US20080249549A1 - Skin lesion exciser and skin-closure device therefor - Google Patents
Skin lesion exciser and skin-closure device therefor Download PDFInfo
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- US20080249549A1 US20080249549A1 US12/062,085 US6208508A US2008249549A1 US 20080249549 A1 US20080249549 A1 US 20080249549A1 US 6208508 A US6208508 A US 6208508A US 2008249549 A1 US2008249549 A1 US 2008249549A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3209—Incision instruments
- A61B17/32093—Incision instruments for skin incisions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/3211—Surgical scalpels, knives; Accessories therefor
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms
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- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00747—Dermatology
- A61B2017/00761—Removing layer of skin tissue, e.g. wrinkles, scars or cancerous tissue
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
- A61B2017/081—Tissue approximator
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/122—Clamps or clips, e.g. for the umbilical cord
- A61B2017/1225—Clamps or clips, e.g. for the umbilical cord for clipping and cutting in a single operation
Definitions
- the present invention relates to the excision of skin tags, moles, lesions and other types of discrete patches or points on the skin (herein collectively referred to as lesions) from a human or animal.
- the current medical practice model for treatment of skin cancer involves preliminary screening of skin lesions. This requires surgical excision of the skin lesion typically done in the office of a plastic surgeon.
- Alternative methods by which dermatologists can biopsy lesions in screening for cancer include shaving small segments for microscopic analysis, or punch biopsy.
- a punch biopsy involves coring out a small sample of the skin lesion and then leaving the skin defect open with a covering bandage. Because it is such a small sample, no skin closure is used.
- the first approach is often a visit to the family practice physician or internist. At that time, evaluation of the lesion is performed and if necessary, referral to the dermatologist or plastic surgeon is given.
- Plastic surgeons or other physicians performing surgical excision typically prepare and drape the area, inject the area locally with an anesthetic such as lidocaine, and then perform a surgical excision using a scalpel.
- the skin is re-approximated and closed using suture material, which is sewn and then tied.
- devices and methods are provided by which skin lesions are excised safely and effectively with substantially simultaneous closure of the skin.
- the excision and closure of the excision site through use of the present invention could change the paradigm for screening and treatment of skin cancer in the industrialized world.
- inventive devices are quick and easy to manipulate, and the method requires only a minimum of local anesthesia or analgesia for patient comfort.
- inventive methods could be performed in the office of the internist or family practice physician where the patient initially presents and often by a physician extender, such as a nurse practitioner, under the supervision and guidance of the physician.
- the present invention Through use of the present invention, it would be unnecessary for patients to make a secondary appointment with another physician for examination and potential excision of the lesion.
- the usual 30-minute procedure could be reduced to 2 or 3 minutes using the present invention.
- the excised lesion may be easily retrieved from the inventive device and submitted for pathologic examination.
- the present invention also provides a device for excising tissue and closing a wound that results from excision of the tissue.
- the device comprises structure defining an aperture into which tissue to be excised is exposed, a cutting member for excising the tissue, a closure member for closing the wound, and an actuatable drive member associated with the structure.
- the drive member is actuatable to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture and for closing the wound with the closure member.
- the present invention also provides a method for excising tissue and closing a wound that results from excision of the tissue.
- the method comprises the steps of: exposing the tissue to be excised into an aperture formed in a structure; moving a portion of a drive member over a first distance to move a closure member into engagement with the tissue that is exposed in the aperture; moving the drive member over a second distance beyond the first distance so as to move a cutting member relative to the aperture for excising the tissue that is exposed in the aperture; and moving the drive member over a third distance beyond the second distance for closing the wound with the closure member.
- the present invention still further provides a method for excising tissue and closing a wound that results from excision of the tissue.
- the method comprises the steps of exposing the tissue to be excised into an aperture formed in a structure; moving a portion of a drive member over a first distance to move a closure member into a closed condition for clamping the tissue that is exposed in the aperture; moving the drive member over a second distance beyond the first distance so as to move a cutting member relative to the aperture for excising the tissue that is exposed in the aperture.
- the present invention also provides an exciser for excising tissue.
- the exciser comprises structure defining an aperture into which tissue to be excised is exposed, a cutting member for excising the tissue, and an actuatable drive member associated with the structure.
- the drive member is actuatable to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture.
- the exciser also comprises an actuator handle that is associated with the drive member. Movement of the actuator handle relative to the structure actuates the drive member.
- the present invention also provides a method of excising tissue.
- the method comprises the steps of: exposing tissue into an aperture defined in a structure; supporting a cutting member on an actuatable drive member that is movable relative to the structure; associating an actuator handle to the drive member; and moving the actuator handle to actuate the drive member to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture.
- the present invention also provides a closure member for clamping tissue adjacent a wound.
- the closure member comprises a planar body portion including first and second retaining portions and a deformable portion that connects the first and second retaining portions.
- the closure member has an open condition in which the deformable portion spaces the first and second retaining portions apart from one another so that the tissue to be clamped may be placed between the first and second retaining portions.
- the closure member also has a closed condition in which the deformable portion is elastically deformed to bring the first and second retaining portions together to clamp the tissue between the first and second retaining portions.
- the body portion of the closure member is planar in both the open and closed conditions.
- the closure member further includes a first set of tines that extends outwardly of the first retaining portion and a second set of tines that extends outwardly of the second retaining portion.
- the first and second sets of tines engage the tissue to secure the body portion to the tissue when the closure member is in the closed condition.
- FIG. 1 is an oblique view of a first embodiment of the inventive device positioned against the skin of the patient and in a first state, prior to lesion excision, with the forceps retracted;
- FIG. 2 shows the device of FIG. 1 in a second, sequential state, prior to lesion excision, with the forceps extended and capturing the lesion to be excised;
- FIG. 3 shows the device of FIG. 1 in a third, sequential state, prior to lesion excision, with the forceps shown in a lesion-pulling position and the safety pin removed;
- FIG. 4 shows the device of FIG. 1 in a fourth, sequential state, during lesion excision, with the staple partially closed through the skin surrounding the lesion;
- FIG. 5 shows the device of FIG. 1 in a fifth, sequential state, during lesion excision, with the staple more fully closed;
- FIG. 6 shows the device of FIG. 1 in a sixth, sequential state, after lesion excision, with the staple fully closed, the forceps being withdrawn from the device and removing the lesion from the skin;
- FIG. 7 shows the device of FIG. 1 in a seventh, sequential state, after lesion excision, the device housing being removed from the skin, the forceps holding the excised lesion fully removed from the device housing;
- FIG. 8 is an enlarged fragmentary sectional view of the exciser of FIG. 1 along line 8 - 8 , showing the staple retention feature of the housing and the position of a lesion to be excised from the skin;
- FIG. 9 is an oblique view of a second embodiment of the inventive device located on the skin of the patient, assembled and in a first, open position;
- FIG. 10 is a view of the component parts of the device of FIG. 9 in a disassembled state
- FIG. 11 is an oblique view of the first applicator block of the device of FIG. 9 , with the male staple half inserted therein;
- FIG. 12 is an oblique view of the second applicator block of the device of FIG. 9 , with the female staple half inserted therein;
- FIG. 13 is an oblique view of the blade assembly of the device of FIG. 9 ;
- FIG. 14 is an oblique view of the blade assembly of FIG. 13 fitted to the second applicator block of FIG. 12 ;
- FIG. 15 is a view of the male and female staple halves of FIGS. 11 and 12 , respectively, shown interfitted;
- FIG. 16 shows the device of FIG. 9 in a first state, prior to lesion excision
- FIG. 17 shows the device of FIG. 9 in a second, sequential state, prior to lesion excision and during interfitting of the staple halves;
- FIG. 18 shows the device of FIG. 9 in a third, sequential state, prior to lesion excision but after closure of the staple;
- FIG. 19 shows the device of FIG. 9 in a forth, sequential state, during lesion excision
- FIG. 20 shows the device of FIG. 9 in a fifth, sequential state, upon lesion excision
- FIG. 21 shows the device of FIG. 9 in a sixth, sequential state, after upon completion of the excision and during partial release of the closed staple from the device;
- FIG. 22 is an oblique view of a third embodiment of the inventive device.
- FIG. 23 is a sectional view of the device of FIG. 22 in a fully opened state
- FIG. 24 is a sectional view of the device of FIG. 22 in a first state, prior to lesion excision, the integral tweezers or forceps of the device closed on the lesion to be excised;
- FIG. 25 shows the device of FIG. 22 in a second, sequential state, prior to lesion excision and during closure of the staple halves through the skin surrounding the lesion;
- FIG. 26 shows the device of FIG. 22 in a third, sequential state, subsequent to closure of the staple and during lesion excision;
- FIG. 27 shows the device of FIG. 22 in a fourth, sequential state, subsequent to lesion excision and during removal of the excised lesion from the skin;
- FIG. 28 is a side view of a fourth embodiment of the inventive device in a fully opened state, with separate, known tweezers or forceps also shown;
- FIG. 29 shows the separate tweezers pulling the lesion away from the skin and the device of FIG. 28 in a second, sequential state prior to lesion excision and during closure of the staple halves through the skin surrounding the lesion;
- FIG. 30 shows the device of FIG. 28 in a third, sequential state, after closure of the staple and during lesion excision;
- FIG. 31 shows the device of FIG. 28 in a fourth, sequential state, subsequent to lesion excision and during removal of the excised lesion from the skin with the tweezers;
- FIG. 32 is a disassembled view of a first embodiment of a two-piece staple for use with the inventive device of FIG. 22 or 28 , the staple pieces shown attached thereto;
- FIG. 33 is a disassembled view of a second embodiment of a two-piece staple for use with the inventive device of FIG. 22 or 28 , the staple pieces shown attached thereto.
- FIGS. 34 a - 34 d schematically illustrate a sectional view a device constructed in accordance with a fifth embodiment of the present invention
- FIG. 35 is an oblique view of a first exemplary device constructed in accordance with the fifth embodiment of the present invention.
- FIG. 36 is an oblique, exploded view of the device of FIG. 35 ;
- FIG. 37 is a sectional view of the device of FIG. 35 ;
- FIG. 38 is a plan view of a drive member of the device of FIG. 35 in a first position relative to a base plate portion of the device;
- FIG. 39 is a plan view of the drive member in a second position relative to the base plate portion
- FIG. 40 is a plan view of the drive member in a third position relative to the base plate portion
- FIG. 41 is a plan view of the drive member in a fourth position relative to the base plate portion
- FIG. 42 is an oblique view of a second exemplary device constructed in accordance with the fifth embodiment of the present invention.
- FIG. 43 is an oblique, exploded view of the device of FIG. 42 ;
- FIG. 44 is a sectional view of the device of FIG. 42 ;
- FIG. 45 is a plan view of a drive member of the device of FIG. 42 in a first position relative to a base plate portion of the device;
- FIG. 46 is a plan view of the drive member in a second position relative to the base plate portion
- FIG. 47 is a plan view of the drive member in a third position relative to the base plate portion
- FIG. 48 is a plan view of the drive member in a fourth position relative to the base plate portion
- FIG. 49 is a first exemplary embodiment of a closure member for use with the devices of FIGS. 35 and 42 ;
- FIG. 50 is a second exemplary embodiment of a closure member
- FIG. 51 is a third exemplary embodiment of a closure member
- FIG. 52 is a fourth exemplary embodiment of a closure member
- FIG. 53 is a fifth exemplary embodiment of a closure member
- FIG. 54 is a sixth exemplary embodiment of a closure member
- FIG. 55 is a seventh exemplary embodiment of a closure member
- FIG. 56 is an eighth exemplary embodiment of a closure member
- FIG. 57 is a ninth exemplary embodiment of a closure member
- FIG. 58 is a tenth exemplary embodiment of a closure member
- FIG. 59 is an eleventh exemplary embodiment of a closure member
- FIG. 60 is a twelfth exemplary embodiment of a closure member
- FIG. 61 is a thirteenth exemplary embodiment of a closure member
- FIG. 62 is a fourteenth exemplary embodiment of a closure member.
- FIG. 63 is a fifteenth exemplary embodiment of a closure member.
- FIG. 1 shows exciser 10 , a first embodiment of the present invention which includes base assembly 12 and separable forceps assembly 14 . It is envisioned that exciser 10 may be a single use device, all or part of which may be discarded after a lesion has been excised therewith.
- Base assembly 12 includes transparent, elongate plastic housing or frame 16 which, as shown, has the shape of a parallelepiped. If is envisioned, however, that housing 16 may be of any suitable shape.
- the lower side of housing 16 that side which, in use, lies against skin S of the patient, is provided with rectangular first aperture 18 which frames lesion L to be excised.
- first aperture 18 which frames lesion L to be excised.
- the upper side of housing 16 is provided with circular second aperture 20 into which the end of cylindrical body 22 of forceps assembly 14 is inserted.
- Forceps assembly 14 further includes forceps or tweezers 24 having a pair of elongate, separable, somewhat flexible arms which are retractable into and extendable from the interior of cylindrical forceps body 22 , and spring 26 which acts to urge tweezers 24 into the interior body 22 .
- Forceps assembly 14 is also provided with plunger 28 which, when depressed with the thumb, urges tweezers 24 out of body 22 against the action of spring 26 , the extended tweezers urged into an open position in which its arms are spread. Release of plunger 28 allows spring 26 to force tweezers 24 upwardly and into body 22 , closing the tweezers.
- forceps assembly 14 may include a mechanism similar to slender, elongate tools commonly used by mechanics for grasping small parts such as screws and nuts, for example, which have been dropped into hard to reach places. Such grasping tools typically employ spring-biased tweezers which are opened by depression of a plunger, as described above.
- forceps assembly 14 may include a mechanism (not shown) by which tweezers 24 are similarly extended from a body and opened, or retracted into the body and closed, by turning a screw threaded into the body, the tip of the screw attached to the tweezers inside the body.
- second aperture 20 may be enlarged, or housing 16 otherwise adequately fashioned to allow the lesion to be manually captured with an ordinary pair of tweezers or forceps.
- Unitary staple 30 in its opened condition, is somewhat V-shaped, having a pair of distant, splayed straight legs, 32 and 34 , each having an end integrally connected to central portion 36 which extends between one end of the legs.
- the free, end of legs 32 and 34 are respectively provided with barbs 38 and 40 which, when the legs are proximate and the staple is closed, interlock and hold the staple in its closed condition.
- Staple 30 may be lightly adhered to the inside surface of housing 16 to help maintain its position prior to being closed.
- the interfacing, or inward sides of legs 32 and 34 are provided with a plurality of pointed pins 42 which extend therefrom and which, when the staple is closed, are alternating relative to the legs from which they extend.
- the pointed free end of each pin 42 abuts or is at least proximal the inward side of the opposite leg.
- staple 30 and/or any of the other skin-closure devices or staples described further herein below, are exemplary embodiments which may be adapted for use with the inventive excisers. It is envisioned that other types of skin-closure devices which serve to close or maintain closed the skin at the lesion excision site may also be in accordance with the present invention, and such devices or the use thereof fall within the scope of the present invention.
- Housing 16 is provided with inverted U-shaped clip 43 ( FIG. 8 ) which is integrally molded or otherwise attached thereto at the edge of rectangular first aperture 18 nearest blade assembly 44 .
- Clip 43 surrounds three sides of staple central portion 36 to prevent its movement longitudinally of housing 16 when engaged by the blade assembly, as disclosed further below.
- the opening of clip 43 is located over first aperture 18 such that, upon removal of base assembly 12 from the skin of the patient after excision of the lesion, closed staple 30 may exit the housing with clearance between its central portion 36 and the adjacent edge of first aperture 18 .
- excisers and skin-closure devices of different sizes may be provided to accommodate the excision various sized lesions and closure of skin at the excision site.
- blade assembly 44 which includes surgical steel blade 46 fixed between wedges or hammers 48 and 50 .
- Hammers 48 and 50 are staple-engaging portions of blade assembly 44 and are provided with surfaces 52 and 54 which are curved or flat and are oblique to the longitudinal axis 55 of housing 16 .
- surfaces 52 and 54 which are curved or flat and are oblique to the longitudinal axis 55 of housing 16 .
- hammers 48 and 50 and blade 46 move coincidentally such that surfaces 52 and 54 slidably engage legs 32 and 34 of staple and move legs 32 and 34 together, thereby closing the staple and the skin simultaneously with the excision of the lesion from the skin by blade 46 .
- the sharp edge of blade 46 is located adjacent to surfaces 52 and 54 , and slicing of the lesion from the skin occurs as opposite portions of legs 32 and 34 along axis 55 are squeezed together by surfaces 52 and 54 to their closed distance from each other.
- above-described clip 43 is located well beneath blade 46 so that the clip will not interfere with the blade's movement.
- Blade assembly 44 further includes block 56 to which hammers 48 and 50 and blade 46 are attached.
- Block 56 is provided with post 58 which extends vertically and hole 60 ( FIGS. 3-7 ) which extends laterally.
- Base assembly 12 is also provided with removable elongate safety pin 62 which, prior to actuation of exciser 10 , extends into hole 60 and through hole 64 in housing 16 .
- Compression spring 66 is provided inside housing 16 , and has one end fixed relative to the housing; the other end abuts block 56 .
- Spring 66 thus urges blade assembly 44 from its cocked position along axis 55 toward staple 30 .
- blade assembly 44 With safety pin 62 installed, blade assembly 44 is retained in its cocked position against the force of compression spring 66 and may not be inadvertently actuated or triggered. With safety pin 62 installed, blade assembly 44 thus may not be slidably moved within housing 16 along axis 55 .
- Base assembly 12 also provided with plunger 68 which extends through the lateral wall of housing 16 and has head 70 , the depression of which triggers, blade assembly 44 once safety pin 62 has been removed.
- Plunger 68 is provided with J-shaped latching end or hook 72 which, in the blade assembly cocked position, partially, surrounds post 58 , the free end of hook 72 extending laterally in a direction perpendicular to axis 55 and abutting the post. Depression of plunger head 70 moves plunger 68 laterally such that post 58 is no longer captured within hook 72 and, with safety pin 62 removed, spring 66 will then immediately force blade assembly 44 to move along axis 55 toward the lesion and staple 30 .
- Parallel lines 74 and 76 are etched or printed onto the transparent lateral sides of body 16 , and blade 46 lies and moves in a plane containing lines 74 and 76 ; these lines thus establish the location on the skin at which the lesion will be excised by the blade.
- the doctor or nurse practitioner can establish the desired elevated position of the lesion by first sighting lines 74 and 76 laterally through the body such that they are viewed as being superposed, and adjusting the lesion with forceps assembly 14 , if and as necessary, such that perimeter P of lesion L, which may be irregularly shaped, is pulled to a position above the superposed lines, as best shown in FIG. 8 . So positioned, the lesion will, after actuation of the blade assembly, be placed in proximity to blade 46 which cuts the skin located outside lesion perimeter P. In adjusting forceps assembly 14 , its body 22 may be moved relative to base assembly housing 16 , or its plunger 28 may be pulled further upward, drawing tweezers 24 further into body 22 .
- the lesion may be captured manually using an ordinary pair of tweezers or forceps and appropriately positioned prior to triggering blade assembly 44 .
- the lesion may be captured with a skin hook (not shown) and appropriately positioned prior to triggering the blade.
- blade assembly 44 is triggered by depression of plunger head 70 .
- plunger hook 72 sliding clear of block post 58 .
- blade assembly 44 quickly moves along axis 55 .
- Blade 46 passes below the free ends of tweezers 24 and through the skin outside of lesion perimeter P, slicing the lesion from the skin while staple 30 simultaneously closes the skin at a location below the excision site.
- pins 42 pierce and protrude through the skin of the patent, and hold the staple in place and prevent it from being pulled from the re-approximated skin after closure.
- the shorn edges of the skin on opposite sides of the excision are captured between staple legs 32 , 34 , and are upwardly diverted, resulting in a desirable, elliptically-shaped closure. Further, the dermis of these shorn skin edges, rather than merely the epidermis, is brought into abutting contact, thereby allowing the stronger parts of the skin to mend together and speeding the excision site healing time.
- the flat interfacing and parallel surfaces of hammers 48 and 50 are spaced such that central portion 36 of staple 30 fits closely therebetween and when barbed ends 38 and 40 of the staple become interlocked, the staple will assume a rectangular shape which is smaller than the periphery of rectangular first aperture 18 .
- Blade assembly 44 After blade assembly 44 has traveled its entire distance along axis 55 , the lesion will be fully excised from the skin and staple 30 is completely closed.
- Base assembly 12 may then be removed from the patient's skin, closed staple 30 passing through first aperture 18 .
- Forceps assembly 14 still gripping the excised lesion, may then be withdrawn from hole 20 of housing 16 . In FIG.
- forceps assembly 14 is shown having been completely and separably withdrawn from base assembly 12 with the excised lesion captured between the ends of tweezers 24 .
- the excised lesion may then be discarded or sent to a laboratory for biopsy or other analysis as appropriate.
- Staple 30 may be removed by cutting it, perhaps at its central portion 36 , and peeling its legs 32 , 34 away from the skin and withdrawing pins 42 therefrom.
- exciser 100 a second embodiment of the present invention which was prototyped and successfully used in animal experiments.
- Exciser 100 comprises first applicator block 102 and second applicator block 104 . Disposed between the applicator blocks is blade assembly 106 . Guide rods 108 are fixed within bores 110 provided in first applicator block 102 and slidably extend through bores 112 in second applicator block 104 . First and second applicator blocks 102 and 104 may be made of a polymeric material such as nylon, for example.
- Blade assembly 106 comprises block portion 114 and blade 116 .
- Block portion 114 is made of a material similar to that of applicator blocks 102 , 104 , and blade 116 is surgical steel or suitable plastic material, like blade 46 of first embodiment exciser 10 .
- Blade 116 is attached to block portion 114 through means of fastener 120 or by any other suitable means.
- Guide rods 108 slidably extend through bores 118 provided in blade assembly block portion 114 .
- Two-part staple 122 comprises interfitting male half 124 and female half 126 .
- Male staple half 124 comprises a pair of parallel rod portions 128
- female staple half 126 comprises a pair of similarly spaced parallel tube portions 130 .
- Rod portions 128 each include extending portion 132 and pointed engaging portion 134 .
- Tube portions 130 each include extending portion 136 and engaging portion 138 .
- each solid engaging portion 134 of the male staple half slidably and interferingly engages its mating hollow engaging portion 138 of female staple half 124 during closure of the staple.
- staple 122 When staple halves 124 and 126 are separated or less than fully seated, staple 122 is in its open condition, and when staple halves 124 and 126 are fully engaged, staple 122 is in its closed condition.
- the interference fit between engaging portions 134 and 138 ensure that staple 122 remains in its closed condition after excision of the lesion.
- legs 140 and 142 When fitted into exciser 100 , or when staple 122 is closed, legs 140 and 142 are parallel and extend in directions perpendicular to the longitudinal directions of rod and tube portions 128 , 130 .
- Each of legs 140 and 142 is provided with a plurality of sharpened pins 144 , which correspond to pins 42 of first embodiment exciser 10 shown in FIGS. 1 through 8 .
- Pins 144 extend in the longitudinal directions of engaging portions 134 and 136 and, when the staple 122 is closed, the pins of the male and female staple halves are misaligned such that they alternate along the legs, and the pointed tips of the pins of one staple half are in close proximity to the leg of the opposite staple half. Notably, when staple 122 is closed as shown in FIG. 15 , engaging portions 134 of male staple half 124 extend beyond the engaging portion 138 of female staple half 126 and into the female staple half's tubular extending portions 136 .
- the distance between parallel legs 140 and 142 when staple 122 is closed may be limited by the length of female staple half engaging portion 138 relative to its leg 142 , i.e., the ends of engaging portions 136 abut leg 140 , thereby minimizing the distance between the staple legs.
- holes 146 receive extending portions 132 of male staple half 124 , and the male staple half is slid into first applicator block 102 until the interfacing surfaces of the first applicator block and leg 140 abut.
- extending portions 136 of female staple half 126 are slidably received in holes 148 provided in second applicator block 104 , with the interfacing surfaces of the second applicator block and leg 142 abutting.
- FIGS. 9 and 16 show exciser 100 loaded with a staple 122 and in its open condition, in which legs 140 and 142 are distant. So configured, exciser 100 is placed onto skin S of the patient. Perimeter P of lesion L to be excised is framed between legs 140 and 142 of the staple and also between the parallel engaging portions 134 of the male staple half 124 . Is it again noted that excisers and staples of different sizes may be provided to accommodate the excision various sized lesions and closure of the excision site.
- first applicator block 102 is held stationary relative to the patient's skin and second applicator block 104 and blade assembly 106 are moved relative to first applicator block 102 along guide rods 108 .
- Lesion L to be excised with exciser 100 may be pulled away from skin S through a means of ordinary tweezers or forceps (not shown). Alternatively, the lesion may be captured and pulled away from the skin with a skin hook (not shown). Lesion L is pulled through exciser 100 , between the staple legs and the engaging portions of the male staple half, to an extent which places its perimeter P on the side of the plane defined by blade 116 opposite that on which staple 122 is located. This ensures that the entire lesion, and not just a portion thereof, will be excised by blade 116 and the staple will close the skin beneath the excision site by pinching together, between proximate legs 140 , 142 , only skin located outside of perimeter P.
- the sharpened pins of the staple pierce the skin and hold the staple in place on the patient during healing.
- the excision site is closed by staple 122 into ah elliptical shape, and the dermis of the skin, rather than merely the epidermis is brought into and held in abutting contact by the closed staple to promote faster healing.
- FIGS. 16-20 the sequence of movements of exciser 100 and its staple halves are shown sequentially. Prior to the cutting of the skin by blade 116 , it can be seen ( FIGS. 16-18 ), that planar blade 116 overlies flat surface 150 of second applicator block 104 and thus cannot begin cutting engagement with me patient's skin until blade assembly 106 is moved relative to second applicator block 104 along guide rods 108 .
- FIG. 17 shows the second applicator block 104 and blade assembly 106 having been moved together along guide rods 108 toward first applicator block 102 such that engaging portions 134 and 138 of male and female staple halves 124 and 126 have entered into partial engagement.
- closure of staple 122 has begun prior to any cutting by blade 116 .
- FIG. 18 shows that further movement of second applicator block 104 and blade assembly 106 together along guide rods 108 toward first applicator block 102 has completely closed staple 122 , applicator blocks 102 and 104 being in their closest proximity to each other.
- exciser 10 in which excision of the lesion and closure of the excision site are done substantially simultaneously exciser 100 completely closes staple 122 prior to any cutting by blade 116 .
- Lesion L which had previously been pulled outwardly away from the rest of the patient's skin by ordinary tweezers or forceps, is held in place such that its perimeter P is above the plane defined by flat blade 116 by the staple.
- Pins 144 which pierce the skin, support the lesion above the plane defined by flat blade 116 ; but the lesion may still be grasped by the tweezers or forceps for easy handling after excision.
- FIG. 19 it can be seen that movement of blade assembly 106 relative to second applicator block 104 along guide rods 108 and toward first applicator block 102 forces blade 116 over the closed staple and through the patient's skin, preferably outside of the perimeter of the lesion.
- blade 116 it is received in recess 152 formed in first applicator block 102 .
- exciser 100 is shown in a position in which the lesion has been completely severed and perhaps removed from the excision site by the tweezers or forceps. In this position, the interfacing surfaces of first applicator block 102 and blade assembly block portion 114 abut, and further movement of blade assembly 106 along guide rods 108 away from second applicator block 104 is prevented.
- blade assembly 106 is reversely slid along guide rods 108 back to its initial position relative to second applicator block 104 , and second applicator block 104 and blade assembly 106 are held together.
- First applicator block 102 is moved away from second applicator block 104 and blade assembly 106 , withdrawing guide rods 108 therefrom.
- Extending portions 132 of staple 122 are withdrawn from holes 146 in first applicator block 102 .
- the position of staple 122 of course remains stationary relative to skin S.
- Extending portions 136 of staple 122 are then withdrawn from holes 148 in second applicator block 104 and the exciser completely removed from the patient.
- staple 122 may then be trimmed to reduce the size of the staple.
- staple 122 would remain in place for approximately four days while the excision site heals, after which the staple halves may be separated by pulling them apart, overcoming the interference fit between the engaging portions 134 and 136 .
- the staple may be cut in any convenient manner such that it may be removed in pieces from the patient.
- exciser 200 a third embodiment of the present invention which is formed of elongate first and second halves 202 and 204 , each respectively having a handle portion 206 , 208 and a jaw portion 210 , 212 .
- First and second halves 202 and 204 are pivotally joined together through rivets 214 to form a basic structure similar to an ordinary pair of pliers or clippers.
- Formed in first and second halves 202 and 204 is central recess 216 , in which is disposed barrel 218 .
- Barrel 218 has the general form of a parallelepiped having closed sides and open ends.
- barrel 218 Opposite sides of barrel 218 are provided with holes through which rivets 214 extend, thereby securing barrel 218 to the rest of exciser 200 .
- Extending through the open ends of barrel 218 are integral tweezers or forceps 220 comprising first and second flexible arms 222 and 224 . Arms 222 and 224 are fixed together at attached end 226 of tweezers 220 .
- Fixed to attached end 226 are short rods 228 which are separated from and attached to each other through neck 230 .
- Rods 228 extend in directions parallel to the longitudinal axes of rivets 214 .
- Neck 230 extends through slot 232 centrally provided in elongate spring steel strip 234 , the opposite ends 236 of which are pivotally attached to first and second exciser halves 202 and 204 .
- Spring steel strip is plastically deformed at its center, and retains and controls longitudinal movement of integral tweezers or forceps 220 through the engagement of rods 228 with the portions of strip 234 on opposite sides of slot 232 .
- First and second arms 222 and 224 of tweezers 220 are provided with plastically deformed portions 238 which, when tweezers 220 are longitudinally moved in the direction of arrow 252 , causes the opposed free ends 240 of first and second arms 222 and 224 to move towards each other and close.
- the closing action of free ends 240 of integral tweezers or forceps 220 capture the lesion to be excised, and longitudinal movement of tweezers 220 in the direction of arrow 252 pulls the lesion to be excised away from the skin.
- Jaw portions 210 and 212 are each provided with opposed blades or cutting edges 242 which, when the jaws are closed, move towards each other and, when the jaws are fully closed, abut each other.
- blades 242 , jaw portions 210 , 212 , halves 202 , 204 or indeed entire exciser 200 may be made of surgical stainless steel.
- first and second separate staple halves 246 and 248 which comprise staple 250
- staple 250 another embodiment of a skin-closure device in accordance with the present invention.
- staple halves 246 and 248 are separated or at least not fully engaged, staple 250 has an open condition.
- First and second staple halves 246 and 248 are, and thus staple 250 is, closed through manipulation of exciser 220 which interlocks the staple halves to each other. With the staple halves in this fully engaged state, the staple has a closed condition.
- exciser 200 is now discussed with reference to FIGS. 24-27 .
- free ends 240 of the integral tweezers or forceps capture lesion L to be excised from skin S, and the lesion is pinched therebetween as handle portions 206 and 208 are closed towards each other slightly.
- a third sequential state shown in FIG. 26 handle portions 206 and 208 have been brought further together, and tweezers have moved further in the direction of arrow 252 .
- staple 250 is fully closed, and blades 242 are brought into abutting engagement with each other, severing lesion L from skin S below lesion perimeter P.
- staple 250 may achieve its fully closed condition prior to actual engagement of blades 242 with skin S, the closing of the staple and the excision of lesion L may alternatively occur substantially simultaneously.
- exciser 200 In a fourth sequential state shown in FIG. 27 , exciser 200 , with excised lesion L still captured between tweezer free ends 240 , is removed from the patient, staple 250 having closed skin S below the excision site such that the dermis located on opposite sides of the excision site are in abutting contact and an elliptically-shaped closure wound is formed as described above.
- the adhesive which holds staple halves 246 and 248 to their respective flat surfaces 244 of the staple-engaging portions at the free ends of the exciser jaws, breaks free upon slight release of handle portions 206 , 208 which are urged away from each other by spring steel strip 232 , and exciser 200 can then be freely removed, leaving staple 250 behind.
- tweezers 220 As handle portions 206 , 208 are more fully released, tweezers 220 move in a direction opposite to arrow 252 , allowing free ends 240 to separate, freeing excised lesion L.
- exciser 300 a fourth embodiment of a device according to the present invention, in a series of sequential states of operation.
- Exciser 300 like exciser 200 has a basic structure similar to that of an ordinary pair of pliers or clippers, and a common skin-closure device may be used with these exciser embodiments.
- Exciser 300 has a pair of elongate first and second halves 302 and 304 , each respectively having handle portion 306 , 308 and jaw portion 310 , 312 , halves 302 and 304 being pivotally joined together by pin 314 .
- exciser 300 is used with separate, known tweezers or forceps 320 as shown. Tweezers 320 are used to capture and pull lesion L away from the skin S of the patient prior to moving handle portions 306 and 308 towards each other to close the skin closure device or staple, and excise lesion L. Alternatively; the lesion may be captured and pulled with a skin hook (not shown). Except for these differences, the structure and operation of exciser 300 are substantially identical to those of exciser 200 .
- Exemplary tweezers 320 have first and second arms 322 and 324 joined at attached end 326 . With the ends of jaw portions 310 , 312 placed against skin S and lesion L placed loosely therebetween, tweezer free ends 340 , which may be serrated, grasp lesion L which is then pulled away from skin S of the patient and into the jaws of exciser 300 . Once the captured lesion has been pulled into jaw portions 310 and 312 to an extent that lesion perimeter P is above blades 342 , handle portions 306 and 308 are squeezed further together, and staple halves 246 and 248 which comprise staple 250 are brought into engagement with the skin outside the outer perimeter of the lesion L and with each other, as shown in FIG. 29 .
- staple 250 is fully closed on skin S and blades 342 sever lesion L from skin S at a location outside lesion perimeter P, as described above.
- staple 250 may achieve its fully closed condition prior to actual engagement of blades 342 with skin S, the closing of the staple and the excision of lesion L may alternatively occur substantially simultaneously.
- the lesion held by tweezers 320 is then removed from the excision site.
- the jaws of exciser 300 are separated, causing the adhesive, which held staple halves 246 , 248 to flat surfaces 344 of the staple-engaging portions of the jaws, to break free.
- the resulting elliptically-shaped excision wound in which the dermis located on opposite sides of the excision is held in abutting contact by staple 250 , is substantially identical to that resulting from use of exciser 200 .
- staples 250 a and 250 b first and second embodiments of staple 250 which can be used with either of above-described excisers 200 and 300 .
- Identical elements of staples 250 a and 250 b are identified with a common reference numeral, whereas corresponding elements of staples 250 a and 250 b are identified alphanumerically with a common numeric portion an alphabetic character (a or b) which correlates with a particular embodiment staple 250 a or 250 b.
- Each embodiment of staple 250 comprises staple halves 246 and 248 which, in the figure, are respectively shown adhered to flat surfaces 244 , 344 of jaw portions 210 , 310 and 212 , 312 of excisers 200 , 300 .
- Staple halves 246 , 248 may be made of surgical stainless steel or a suitable plastic material.
- Each staple half 246 is provided with elongate flat central portion 360 extending between legs 362 and 364 .
- a suitable releasable adhesive 366 which is later broken free during removal of the exciser from the patient as described above, is provided between the outer planar surface of flat central portion 360 and the abutting surface 244 , 344 of jaw portion 210 , 310 .
- each staple half 248 is provided with elongate flat central portion 370 extending between legs 372 and 374 , staple half 248 being releasably adhered to its mating jaw surface 244 , 344 by adhesive 366 .
- Pointed pins 368 extend from the inner planar sides of flat central portions 360 , 370 , and when staple 250 is closed, the terminal ends of pins 368 of one staple half abut the interfacing inner surface of the other staple half. Further, with staple 250 closed, the pins alternate along the staple length on the basis of which staple half they extend from.
- each staple half 246 , 248 is substantially symmetrical about the center of its central portion 360 , 370 , thereby allowing the staple halves to each be oriented on flat surfaces 244 , 344 in either of two orientations 180 degrees apart; i.e., the locations of legs 362 and 364 of staple half 246 , or the locations of legs 372 and 374 of staple half 248 may be switched relative to the exciser.
- legs 362 a and 364 a are provided with barbs 376 which, when staple 250 a is closed, are interconnected with barbs 378 provided at the ends of legs 372 a and 374 a , the interconnecting barbs holding staple 250 a in its closed condition.
- the interconnection of barbs 376 and 378 occurs as they slide past each other, resiliency deflecting at least one leg of each interconnecting pair, and become hooked to each other.
- the legs 362 b and 364 b are substantially tubular and telescopically engage legs 372 b and 374 b, which are interference fitted therein during closure of staple 250 b to maintain its closed condition.
- the engaging surfaces of legs 362 b, 364 b and 372 b, 374 b may be smooth, their sliding interference fit being substantially as disclosed above with respect to rod portions 128 and tube portions 130 of staple 122 of second embodiment exciser 100 (see FIG. 15 ).
- Staple halves 246 b , 248 b which are made of plastic may alternatively have its legs 372 b, 374 b provided with ribs 380 , as shown in FIG. 33 , which are compressed as they are forced into smooth-walled hollow legs 362 b, 364 b, the compression of ribs 380 providing a secure interference fit between the interconnected legs.
- the interior surfaces of hollow legs 362 b and 364 b may be also provided with recesses 382 into which ribs 380 are received as legs 372 b, 374 b are forced therein, the interfitting engagement of ribs 380 and recesses 382 holding staple 250 b in its closed condition.
- FIGS. 34 a - 34 d schematically illustrate a sectional view a device 410 constructed in accordance with a fifth embodiment of the present invention.
- the device 410 may be used for excising tissue and closing a wound that results from excision of the tissue.
- FIGS. 34 a - 34 d schematically illustrate the device 410 excising a lesion 412 from skin 414 .
- the device 410 includes a housing 418 .
- An aperture 420 extends vertically through the housing 418 .
- the device 410 also includes a cutting member 422 and a clamping member 424 .
- At least one actuator 426 is movable relative to the housing 418 for moving the cutting member 422 and for closing the closure member 424 .
- An optional second actuator that cooperates with the actuator 426 for closing the closure member 424 is shown by dashed lines at 428 in FIGS. 34 a - 34 d.
- the housing 418 is positioned relative to the skin 414 so that the lesion 412 is located directly below the aperture 420 .
- the lesion 412 is pulled through the aperture 420 of the housing 418 using a skin hook 432 or other suitable device for grabbing the lesion 412 .
- the skin 414 adjacent the lesion 412 is tensioned.
- the actuator 426 of the device 410 is moved relative to the housing 418 . Movement of the actuator 426 causes the closure member 424 to begin to close. As the closure member 424 begins to close, tines (not shown) of the closure member 424 pierce the tensioned skin 414 and the closure member begins to pinch the skin adjacent the lesion 412 .
- FIG. 35 is an oblique view of a first exemplary device 510 constructed in accordance with the fifth embodiment of the present invention.
- FIG. 36 is an exploded oblique view of the device 510 and
- FIG. 37 is a sectional view of the device 510 .
- the device 510 includes a housing 512 having a base plate portion 514 and a top plate portion 516 .
- the base plate portion 514 of the housing 512 includes lower and upper surfaces 520 and 522 , respectively. As best shown in FIG. 37 , a cavity 536 extends upwardly into the lower surface 520 of the base plate portion 514 .
- the cavity 536 is generally elliptical and terminates at an upper surface 538 ( FIG. 37 ).
- An elliptical aperture 540 extends through the base plate portion 514 and into the cavity 536 .
- a first recess 544 extends downwardly into the upper surface 522 of the base plate portion 514 . As will be described in detail below, the first recess 544 receives a driver 640 of the device 510 .
- the first recess 544 includes a generally planar bottom surface 546 .
- the first recess 544 includes a narrow section having laterally opposite side surfaces 558 and 560 . Corners 562 and 564 , which preferably have equal radii, form transitions between the laterally opposite side surfaces 558 and 560 and a wider section of the first recess 544 . As will be discussed below, the location of the corners 562 and 564 determines a timing for cutting the lesion and clamping the skin adjacent the lesion.
- FIG. 36 another section of the first recess 544 is located between laterally opposite side surfaces 582 and 584 .
- a protruding portion 586 that includes the elliptical aperture 540 extends upwardly into the first recess 544 in a location between the side surfaces 582 and 584 .
- Two elongated slots 588 and 590 connect the first recess 544 to the cavity 536 on longitudinally opposite ends of the protruding portion 586 .
- Two pivot pin holes 592 and 594 and a second recess 600 extend into the bottom surface 546 of the first recess 544 .
- the pivot pin holes 592 and 594 are located in the slot 590 and a curved end surface 596 of the first recess 544 .
- the second recess 600 extends longitudinally through a center of the first recess 544 .
- Two axially extending ribs 602 extend into the second recess 600 near the curved end surface 596 of the first recess 544 .
- the ribs 602 form three elongated slots in the second recess 600 .
- the base plate portion 514 also includes four fastener holes 604 .
- the four fastener holes 604 extend between the lower and upper surfaces 520 and 522 of the base plate portion 514 .
- the top plate portion 516 of the housing 512 also a lower surface 610 ( FIG. 37 ) and an upper surfaces 612 ( FIG. 36 ).
- An elliptical aperture 621 extends through the top plate portion 516 of the housing 512 .
- the elliptical aperture 621 extends between the lower and upper surfaces 610 and 612 and has a location corresponding the elliptical aperture 540 of the base plate portion 514 .
- the upper surface 612 of the top plate portion 516 is chamfered adjacent the elliptical aperture 621 .
- Each of the four fastener holes 622 is associated with and has a location corresponding to a fastener hole 604 of the base plate portion 514 of the housing 512 .
- Each of the fastener holes 622 is located in a circular boss 628 that extends upwardly above the upper surface 612 of the top plate portion 516 .
- Each of the two pivot pin holes 624 and 626 is associated with and has a location corresponding to a pivot pin hole 592 and 594 of the base plate portion 514 of the housing 512 .
- the slot 634 has a length and width of approximately four times the length and width of the slot 632 .
- the device 510 also includes a driver 640 .
- FIG. 36 illustrates an oblique view of the driver 640 and FIGS. 38-41 illustrate a plan view of the driver located in the first recess 544 of the base plate portion 514 of the housing 512 .
- the protruding portion 586 of the base plate portion 514 that includes the elliptical aperture 540 is not shown.
- the driver 640 is injection molded from a plastic material that is flexible enough to allow for a living hinge to be formed on the driver.
- Exemplary plastic materials include nylon, polycarbonate, polyester, or any other suitable polymer.
- the driver 640 includes a yoke portion 642 and a driving portion 644 .
- the yoke portion 642 of the driver 640 includes longitudinally spaced first and second end portions 650 and 652 , respectively, and laterally spaced first and second side portions 654 and 656 , respectively, that collectively surround a central opening 658 .
- first and second side portions 654 and 656 of the yoke portion 642 of the driver 640 connect the first and second end portions 650 and 652 .
- the second end portion 652 includes first and second pivotal drive portions 680 and 682 that are connected to the first and second side portions 654 and 656 , respectively, with living hinges.
- a pivot pin hole 692 extends through the first pivotal drive portion 680 and a pivot pin hole 708 extends through the second pivotal drive portion 682 .
- the yoke portion 642 of the driver 640 also includes proximal and distal engaging members 714 and 716 .
- the proximal engaging member 714 extends into the central opening 658 from the first end portion 650 .
- the proximal engaging member 714 includes a recessed end portion 734 ( FIG. 37 ).
- the distal engaging member 716 is interposed between the first and second pivotal drive portions 680 and 682 .
- the distal engaging member 716 also includes a recessed end portion 770 ( FIG. 37 ).
- the driving portion 644 of the driver 640 is located longitudinally opposite the first end portion 650 of the yoke portion 642 from the central opening 658 .
- the driving portion 644 includes a blade support portion 778 , and first and second collapsible legs 782 and 784 , respectively.
- the blade support portion 778 includes circular boss 790 ( FIG. 38 ) that extends upwardly from the blade support portion 778 .
- a rectangular protrusion (not shown) extends downwardly from the blade support portion 778 for being received in the second recess 600 of the base plate portion 514 .
- the first and second collapsible legs 782 and 784 are located on laterally opposite sides of the blade support portion 778 .
- the first and second collapsible legs 782 and 784 extend between the blade support portion 778 and the firsts end portion 650 of the yoke portion 642 .
- the first collapsible leg 782 includes first and second leg portions 796 and 798 , respectively. Living hinges connect the first and second leg portions 796 and 798 to one another and to the blade support portion 778 and the first end portion 650 of the yoke portion 642 .
- the second collapsible leg 784 includes first and second leg portions 810 and 812 , respectively. Living hinges connect the first and second leg portions 810 and 812 to one another and to the blade support portion 778 and the first end portion 650 of the yoke portion 642 .
- the device 510 also includes a cutting member or blade 830 .
- the blade 830 includes an aperture 836 that is sized for receiving the circular boss 790 that extends upwardly from the blade support portion 778 of the driving portion 644 of the driver 640 .
- the blade 830 also includes a sharpened edge 838 .
- the blade 830 is formed from surgical steel. In one embodiment of the invention, the blade 830 is formed from 440 stainless steel.
- the device 510 also includes an actuator handle 844 .
- the actuator handle 844 is molded from plastic.
- An aperture 846 extends through the actuator handle 844 for receiving the circular boss 790 that extends upwardly from the blade support portion 778 of the driving portion 644 of the driver 640 and a fastener 848 that fixes the actuator handle 844 to the boss 790 .
- the driver 640 is placed in the first recess 544 of the base plate portion 514 of the housing 512 so that the central opening 658 of the yoke portion 642 of the driver receives the protruding portion 586 of the base plate portion.
- the proximal and distal engaging members 714 and 716 extends through the slots 588 and 590 in the base plate portion 514 and slightly into the cavity 536 ( FIG. 37 ) in the lower surface 520 of the base plate portion 514 .
- the blade 830 is then placed on the driving portion 644 of the driver 640 so that the circular boss 790 extends through the aperture 836 in the blade.
- the blade 830 is also received in the first recess 544 of the base plate portion 514 .
- the side surfaces 558 and 560 of the first portion 550 of the first recess 544 prevent the blade 830 from rotating about the circular boss 790 and relative to the base plate portion 514 .
- the top plate portion 516 of the housing 512 is placed over the base plate portion 514 of the housing.
- the slot 634 of the top plate portion 516 receives the circular boss 790 of the blade support portion 778 of the driving portion 644 of the driver 640 .
- the slot 632 of the top plate portion 516 receives a portion of the distal engaging member 716 .
- pivot pin holes 692 and 708 of the first and second drive portions 680 and 682 of the second end portion 652 of the yoke portion 642 of the driver 640 are aligned with the pivot pin holes 592 and 594 of the base plate portion 514 and the pivot pin holes 624 and 626 of the top plate portion 516 .
- fasteners 854 ( FIG. 35 ) are then inserted through the fastener holes 622 of the top plate portion 516 and the fastener holes 604 of the base plate portion 514 to hold the top plate portion relative to the base plate portion.
- a first pivot pin 856 is inserted through the pivot pin hole 624 of the top plate portion 516 , the pivot pin hole 692 in the first pivotal drive portion 680 of second end portion 652 of the yoke portion 642 , and the pivot pin hole 592 in the base plate portion 514 of the housing 512 .
- a second pivot pin 858 is inserted through the pivot pin hole 626 of the top plate portion 516 , the pivot pin hole 708 in the second pivotal drive portion 682 of second end portion 652 of the yoke portion 642 , and the pivot pin hole 594 in the base plate portion 514 of the housing 512 .
- the aperture 846 in the actuator handle 844 is aligned with the circular boss 790 of the blade support portion 778 of the driving portion 644 of the driver 640 .
- the actuator handle 844 is pressed onto the circular boss 790 and a fastener 848 is inserted into the aperture 846 to lock the actuator handle to the boss.
- the circular boss 790 is located at a first end of the slot 634 .
- the device 510 is turned over so that a clip 870 may be attached to the device.
- exemplary clips are illustrated in FIGS. 49-63 and will be discussed later in this application.
- the clip 870 of FIG. 37 includes opposite first and second retaining portions 872 and 874 , respectively, that when pressed together clamp onto tissue.
- the clip 870 is placed in the cavity 536 that extends into the lower surface 520 of the base plate portion 514 .
- the first retaining portion 872 of the clip 870 is placed on the recessed end portion 734 of the proximal engaging member 714 and the second retaining portion 874 of the clip 870 is placed on the recessed end portion 770 of the distal engaging member 716 .
- the lower surface 520 of the base plate portion 514 of the housing 512 of the assembled device 510 to which the clip 870 has been attached, is placed against the patient's tissue so that the elliptical apertures 540 and 621 overlie the portion of tissue to be removed.
- a skin hook, or another device for grabbing the patient's tissue is inserted through the elliptical apertures 540 and 621 of the housing 512 and hooks the portion of tissue.
- the portion of tissue is pulled through the clip 870 and the elliptical apertures 540 and 621 of the housing 512 so that the tissue is placed under tension.
- Pushing the actuator handle 844 through the slot 634 toward the elliptical aperture 621 actuates the device 510 .
- the first and second collapsible legs 782 and 784 are pressed against the side surfaces 558 and 560 of the first recess 544 in the base plate portion 514 , as is shown in FIG. 38 .
- the first and second collapsible legs 782 and 784 are prevented from collapsing and the movement of the actuator handle 844 causes the yoke portion 642 of the driver 640 begin to close the clip 870 so that tines of the clip penetrate the tissue and the clip begins to pinch the tissue.
- FIG. 39 illustrates the device 510 at a position in which the clip 870 begins to close.
- Adjusting the location of the corners 562 and 564 enables the timing for cutting the tissue with the blade 830 and clamping the tissue with the clip 870 to be controlled.
- the longitudinal lengths of side surfaces 558 and 560 illustrates in FIG. 38 as distance X, controls the timing of when the first and second collapsible legs 782 and 784 of the driving portion 644 begin to collapse.
- the device 510 timing for cutting the tissue with the blade 830 and clamping the tissue with the clip 870 may be adjusted. For example, when the distance X is increased, the yoke portion 642 of the driver 640 will close the clip 870 prior to the driving portion 644 moving the blade 830 to cut the tissue.
- first and second collapsible legs 782 and 784 of the driving portion 644 of the driver 640 move out of contact with the side surfaces 558 and 560 and over corners 562 and 564 , respectively, the first and second collapsible legs 782 and 784 begin to collapse, as is shown in FIG. 39 .
- the blade support portion 778 begins to move toward the first end portion 650 .
- the blade 830 cuts through the tissue that extends through the elliptical aperture 621 of the top plate portion 516 to excise the tissue from the tissue that extends through the elliptical aperture 540 of the base plate portion 514 .
- the tissue that extends into elliptical aperture 540 remains pinched between the first and second retaining portions 872 and 874 of the clip 870 .
- the proximal and distal engaging members 714 and 716 continue to move together as the actuator handle 844 is moved through the slot 634 toward the elliptical aperture 621 .
- the first and second retaining portions 872 and 874 of the clip 870 are pressed together into the position shown in FIG. 41 .
- the clip 870 fully occludes the wound that results from the excision of the tissue.
- the actuator handle 844 is moved in the slot 634 in a direction away from the elliptical aperture 621 . Movement of the actuator handle 844 away from the elliptical aperture 621 causes the proximal and distal engaging member 714 and 716 to move apart from one another and to release the clip 870 .
- the device 510 may be modified to include a biasing member or spring (not shown) that biases the first end portion 650 of the yoke portion 642 of the driver 640 relative to the base plate portion 514 to remove the clip 870 from the proximal and distal engaging member 714 and 716 .
- the biasing member may be an integral part of the driver 640 .
- the device 510 is molded from plastic material.
- the device 510 is a single use device that is discarded after its use, while the clip 870 remains attached to the skin to close the wound.
- FIG. 42 is an oblique view of a second exemplary device constructed in accordance with the fifth embodiment of the present invention.
- FIG. 43 is an exploded oblique view of the device 1010 and
- FIG. 44 is a sectional view of the device 1010 .
- the device 1010 includes a housing 1012 having a base plate portion 1014 and a top plate portion 1016 .
- the base plate portion 1014 of the housing 1012 includes a lower surface 1020 ( FIG. 44 ) and an upper surfaces 1022 ( FIG. 43 ).
- a cavity 1034 ( FIG. 44 ) extends upwardly into the lower surface 1020 of the base plate portion 1014 .
- the cavity 1034 terminates at an upper surface 1036 .
- An elliptical aperture 1038 extends through the base plate portion 1014 through the upper surface 1036 of the cavity 1034 .
- a first recess 1044 extends downwardly into the upper surface 1022 of the base plate portion 1014 .
- the first recess 1044 includes a generally planar bottom surface 1046 .
- a protruding portion 1056 having the elliptical aperture 1038 extends upwardly from the bottom surface 1046 of the first recess 1044 .
- elongated slots 1066 and 1074 are located on opposite sides of the protruding portion 1056 and connect the first recess 1044 to the cavity 1034 .
- the first recess 1044 includes a narrowed section having laterally opposite side surfaces 1058 and 1060 . As shown in FIG. 45 , corners 1062 and 1064 , which preferably have equal radii, form transitions between the laterally opposite side surfaces 1058 and 1060 and a wider section of the first recess 1044 . As will be discussed below, the location of the corners 1062 and 1064 determines a timing for cutting the lesion and clamping the skin adjacent the lesion.
- the first recess 1044 also includes a generally elliptical section that includes arcuate side surfaces 1068 and 1070 .
- the arcuate sides surfaces 1068 and 1070 are located on laterally opposite sides of the protruding portion 1056 .
- a second recess 1080 extends downwardly into the bottom surface 1046 of the first recess 1044 .
- the second recess 1080 extends longitudinally through a center of the first recess 1044 .
- the base plate portion 1014 also includes four fastener holes 1082 .
- the four fastener holes 1082 extend between the lower and upper surfaces 1020 and 1022 of the base plate portion 1014 .
- the top plate portion 1016 of the housing 1012 also includes a lower surface 1088 ( FIG. 44 ) and an upper surfaces 1090 .
- a recess 1102 extends into the upper surface 1090 of the top plate portion 1016 .
- the recess 1102 has a planar bottom surface 1104 .
- An elliptical aperture 1116 extends through the top plate portion 1016 of the housing 1012 .
- the elliptical aperture 1116 extends between the bottom surface 1104 of the recess 1102 and the lower surface 1020 of the top plate portion 1016 .
- the elliptical aperture 1116 has a location corresponding the elliptical aperture 1038 of the base plate portion 1014 .
- Each of the four fastener holes 1118 extend through top plate portion 1116 between the lower and upper surfaces 1020 and 1022 .
- Each of the four fastener holes 1118 is associated with and has a location corresponding to a fastener hole 1082 of the base plate portion 1014 of the housing 1012 .
- Two axially elongated slots 1120 and 1122 extend through the top plate portion 1016 .
- the slots 1120 and 1122 extend along a centerline of the top plate portion 1016 from longitudinally opposite ends of the top plate portion.
- the device 1010 also includes a driver 1130 .
- FIG. 45-48 illustrate plan views of the driver 1130 in the base plate portion 1014 of the housing 1012 .
- the protruding portion 1056 of the base plate portion 1014 that includes the elliptical aperture 1038 is not shown.
- the driver 1130 is injection molded from plastic material and includes a yoke portion 1132 and a cutting portion 1134 .
- the yoke portion 1132 of the driver 1130 includes opposite first and second end portions 1140 and 1142 , respectively, and opposite first and second collapsible legs 1144 and 1146 , respectively.
- a central opening 1148 extends between the first and second end portions 1140 and 1142 and the first and second collapsible legs 1144 and 1146 , respectively.
- first and second collapsible legs 1144 and 1146 connect the first and second end portions 1140 and 1142 .
- the first collapsible leg 1144 includes first and second leg portions 1162 and 1164 , respectively.
- Living hinges connect the first and second leg portions 1162 and 1164 to one another and to the first and second end portions 1140 and 1142 .
- the second collapsible leg 1146 also includes first and second leg portions 1176 and 1178 , respectively. Living hinges connect the first and second leg portions 1176 and 1178 to one another and to the first and second end portions 1140 and 1142 .
- the yoke portion 1132 of the driver 1130 also includes proximal and distal engaging members 1208 and 1210 , respectively.
- the proximal engaging member 1208 extends longitudinally outwardly of the first end portion 1140 and into the central opening 1148 .
- the proximal engaging member includes a recessed end portion 1218 ( FIG. 44 ).
- the distal engaging member 1210 also extends longitudinally into the central opening 1148 .
- the distal engaging member includes a recessed end portion 1230 ( FIG. 44 ).
- the cutting portion 1134 of the driver 1130 is located longitudinally opposite the first end portion 1140 of the yoke portion 1132 from the central opening 1148 .
- the cutting portion 1134 includes a blade support portion 1238 and first and second collapsible legs 1240 and 1242 , respectively.
- a circular aperture 1260 extends through the blade support portion 1238 .
- a rectangular protrusion extends downwardly from the blade support portion 1238 for being received in the second recess 1080 of the base plate portion 1014 .
- the first and second collapsible legs 1240 and 1242 extend longitudinally between the blade support portion 1238 and the first end portion 1140 of the clamping portion 1232 .
- the first collapsible leg 1240 includes first and second leg portions 1266 and 1268 , respectively. Living hinges connect the first and second leg portions 1266 and 1268 together and to the blade support portion 1238 and the first end portion 1140 .
- the second collapsible leg 1242 also includes first and second leg portions 1278 and 1280 , respectively. Living hinges connect the first and second leg portions 1278 and 1280 together and to the blade support portion 1238 and the first end portion 1140 .
- the device 1010 also includes a cutting member or blade 1290 .
- the blade 1290 includes an aperture 1296 and a sharpened edge 1298 .
- the blade 1290 is formed from surgical steel. In one embodiment of the invention, the blade is formed from 440 stainless steel.
- the device 1010 also includes first and second actuator handles 1304 and 1306 , respectively.
- the actuator handles 1304 and 1306 are molded from plastic.
- An aperture 1308 extends vertically through actuator handle 1304 .
- an aperture 1310 extends vertically through actuator handle 1306 .
- the device 1010 also includes six fastener 1314 and two blind nuts 1316 .
- the fasteners 1314 illustrated in FIG. 43 are screws having associated washers 1318 . Alternatively, snap features may be incorporated into the various structures of the device 1010 .
- the six fasteners 1314 include four housing fasteners and two actuator fasteners.
- Each of the two blind nuts 1316 includes a circular boss 1320 and a planar base 1322 .
- the planar bases 1322 of the blind huts 1316 are sized for being received in the second recess 1080 of the base plate portion 1014 of the housing 1012 .
- a circular boss 1320 of one of the blind nut 1316 is inserted into the aperture 1260 of the blade support portion 1238 of the driver 1130 so that the circular boss extends upwardly beyond an upper surface of the blade support portion.
- the circular boss 1320 of the other blind nut 1316 is inserted into an aperture 1202 of the second end portion 1142 so that the circular boss extends upwardly beyond an upper surface of the second end portion.
- the driver 1130 is then placed in the first recess 1044 of the base plate portion 1014 of the housing 1012 so that the central opening 1148 of the yoke portion 1132 of the driver receives the protruding portion 1056 of the base plate portion that includes the elliptical aperture 1038 .
- the driver 1130 When the driver 1130 is placed in the first recess 1044 , the bases 1322 of the blind nuts 1316 and the rectangular protrusions of the blade support portion 1238 , the first end portion 1140 , and the second end portion 1142 are received in the second recess 1080 of the base plate portion 1014 .
- the second recess 1080 acts to guide the driver 1130 during movement relative to the base plate portion 1014 .
- the proximal and distal engaging members 1208 and 1210 extends through the slots 1062 and 1074 in the base plate portion 1014 and slightly into the cavity 1034 of the base plate portion.
- the driver 1130 is positioned within the first recess 1044 so that the first and second collapsible legs 1240 and 1242 of the cutting portion 1134 of the driver 1130 engage the first and second side surfaces 1058 and 1060 of the first portion 1048 of the first recess 1044 , as is shown in FIG. 45 .
- the blade 1290 is then placed over the blade support portion 1238 of the cutting portion 1134 of the driver 1130 so that the circular boss 1320 of the blind nut 1316 that extends through the aperture 1260 in the blade support portion also extends through the aperture 1296 of the blade.
- the blade 1290 is also received in the first recess 1044 of the base plate portion 1014 .
- the first and second side surfaces 1058 and 1060 of the first portion 1048 of the first recess 1044 prevent the blade 1290 from rotating about the circular boss 1320 and relative to the base plate portion 1014 .
- the top plate portion 1016 of the housing 1012 is placed over the base plate portion 1014 of the housing.
- the slot 1120 of the top plate portion 1016 receives the circular boss 1320 of the blind nut 1316 that extends through the aperture 1296 of the blade 1290 .
- the slot 1122 receives the circular boss 1320 of the blind nut 1316 that extends through the second end portion 1142 of the yoke portion 1132 of the driver 1130 .
- fasteners 1314 are then inserted through the fastener holes 1118 of the top plate portion 1016 and the fastener holes 1082 of the base plate portion 1014 to hold the top plate portion relative to the base plate portion.
- the aperture 1308 in the actuator handle 1304 is aligned with and receives the circular boss 1320 of the blind nut 1316 that extends through the aperture 1296 of the blade 1290 .
- a fastener 1314 fixes the actuator handle 1304 to the blind nut 1316 .
- the aperture 1310 in the actuator handle 1306 is aligned with and receives the circular boss 1320 of the blind nut 1316 that extends through the aperture 1202 in the second end portion 1142 .
- a fastener 1314 fixes the actuator handle 1306 to the blind nut 1316 .
- the device 1010 is turned over so that a clip 1326 may be attached to the device.
- exemplary clips are illustrated in FIGS. 49-63 and are discussed later in this application.
- the clip 1326 of FIG. 43 includes opposite first and second retaining portions 1228 and 1230 , respectively, that when pressed together clamp onto tissue.
- the clip 1326 is placed in the cavity 1034 that extends into the lower surface 1020 of the base plate portion 1014 .
- the first retaining portion 1328 of the clip 1326 is supported on the recessed end of the proximal engaging member 1208 and the second retaining portion 1330 is supported on the recessed end of the distal engaging member 1210 .
- the lower surface 1020 of the base plate portion 1014 of the assembled device 1010 to which the clip 1326 has been attached, is placed against a patient's tissue.
- a skin hook, or another device for grabbing the patient's tissue is inserted through the elliptical apertures 1038 and 1116 of the housing 1012 and grabs the tissue.
- the skin hook pulls the tissue through the clip 1326 and the elliptical apertures 1038 and 1116 of the housing 1012 .
- the tissue is placed under tension.
- the first and second actuator handles 1304 and 1306 are pushed together to actuate the driver 1130 .
- the side surfaces 1058 and 1060 of the first portion 1048 of the first recess 1044 prevent the first and second collapsible legs 1240 and 1242 of the cutting portion 1134 of the driver 1130 from collapsing, as illustrated in FIG. 45 .
- the proximal and distal engaging members 1208 and 1210 moves toward one another to begin closing the clip 1326 .
- tines of the clip 1326 pierce the tensioned tissue and the clip begins to pinch the tissue.
- FIG. 46 illustrates the device 1010 with the clip 1326 partially closed.
- Adjusting the location of the corners 1062 and 1064 enables the timing for cutting the tissue with the blade 1290 and clamping the tissue with the clip 1326 to be controlled.
- the longitudinal lengths of side surfaces 1058 and 1060 illustrates in FIG. 45 as distance Y, controls the timing of when the first and second collapsible legs 1240 and 1242 of the cutting portion 1134 of the driver 1130 begin to collapse.
- the distance Y controls the timing of when the first and second collapsible legs 1240 and 1242 of the cutting portion 1134 of the driver 1130 begin to collapse.
- the distance Y controls the timing of when the first and second collapsible legs 1240 and 1242 of the cutting portion 1134 of the driver 1130 begin to collapse.
- the device 1010 timing for cutting the tissue with the blade 1290 and clamping the tissue with the clip 1326 may be adjusted.
- the yoke portion 1132 of the driver 1130 will close the clip 1326 prior to the cutting portion 1134 moving the blade 1290 to cut the tissue.
- the collapsible legs 1240 and 1242 of the cutting portion 1134 of the driver 1130 When the living hinges of the first and second collapsible legs 1240 and 1242 of the cutting portion 1134 of the driver 1130 extend longitudinally beyond the corners 1062 and 1064 , as is shown in FIG. 46 , the collapsible legs 1240 and 1242 begin to collapse. As the actuator handle 1304 continues to move toward through slot 1120 toward the elliptical aperture 1116 , the collapsible legs 1240 and 1242 of the cutting portion 1134 of the driver 1130 collapse into the position illustrated in FIG. 47 and the blade support portion 1238 moves into contact with the first end portion 1140 of the yoke portion 1132 of the driver 1130 . During the movement of the blade support portion 1238 toward the first end portion 1140 , the blade 1290 cuts the tissue that extends through the elliptical aperture 1116 of the top plate portion 1016 of the housing 1012 .
- the tissue that extends through the elliptical aperture 1038 of the base plate portion 1014 of the housing 1012 remains pinched between the first and second retaining portions 1328 and 1330 of the clip 1326 .
- the blade support portion 1238 of the cutting portion 1134 of the driver 1130 contacts the first end portion 1140 of the yoke portion 1132 of the driver, further movement of the actuator handles 1304 and 1306 toward one another and toward the elliptical aperture 1116 moves the proximal engaging member 1208 and the distal engaging member 1210 , respectively, toward a center of the elliptical aperture 1116 .
- the proximal and distal engaging members 1208 and 1210 continue to move together as the actuator handles 1304 and 1306 are moved toward one another so as to press the first and second retaining portions 1328 and 1330 of the clip 1326 together.
- the first and second actuator handles 1304 and 1306 reach the ends of the slots 1120 and 1122 , respectively, the first and second retaining portions 1328 and 1330 of the clip 1326 fully occlude the wound that results from excision of the tissue.
- FIG. 48 illustrates the driver 1130 and the clip 1326 when the clip is in a closed condition.
- the actuator handles 1304 and 1306 are moved away from one another to cause the proximal and distal engaging members 1208 and 1210 to move apart from one another and to release the clip 1326 .
- the device 1010 may be modified to include a biasing member or spring that biases the first end portion 1140 of the yoke portion 1132 of the driver 1130 in a direction for releasing the clip 1326 .
- the biasing member may form an integral part of the driver 1130 .
- the device 1010 is molded from plastic.
- the device 1010 is a single use device that is discarded after its use while the clip 1326 remains attached to the skin to close the wound.
- the device 1010 may come in various sizes for removing lesions of various sizes. When multiple sizes of the device 1010 are available, a template may be supplied for enabling the clinician to determine the correct size of the device 1010 to be used in removing the desired lesion.
- FIG. 49 is a first exemplary embodiment of a closure member or clip 1502 .
- the clip 1052 of FIG. 49 may be used with the devices 510 and 1010 of FIGS. 35 and 42 .
- the clip 1502 is preferably stamped from stainless steel, titanium, or any other bio-compatible metal.
- the clip 1502 includes a planar body portion 1504 .
- the body portion 1504 of the clip 1502 includes first and second retaining portions 1506 and 1508 , respectively, and first and second deformable portions 1512 and 1514 , respectively.
- the first retaining portion 1506 includes opposite first and second ends 1516 and 1518 , respectively.
- the second retaining portion 1508 includes opposite first and second ends 1522 and 1524 , respectively.
- the first deformable portion 1512 connects the first end 1516 of the first retaining portion 1506 and the first end 1522 of the second retaining portion 1508 .
- the first deformable portion 1512 includes three deformation zones 1528 .
- Each of the deformation zones 1528 is formed from a thinned portion of the first deformable portion 1512 .
- Each deformation zone 1528 has a width, measured within the plane of the body portion 1504 of the clip 1502 , i.e., within the plane of FIG. 49 , that is less than a material thickness of the first deformable portion 1512 , measured in a direction perpendicular to the plane of the body portion of the clip, i.e., into FIG. 49 .
- the second deformable portion 1514 connects the second end 1518 of the first retaining portion 1506 and the second end 1524 of the second retaining portion 1508 .
- the second deformable portion 1512 also includes three deformation zones 1530 .
- Each of the deformation zones 1530 of the second deformable portion 1514 has a width, measured within the plane of the body portion 1504 of the clip 1502 , that is less than a material thickness of the second deformable portion 1514 , measured in a direction perpendicular to the plane of the body portion of the clip.
- An oblong or elliptical opening 1532 is formed between the first and second retaining portions 1506 and 1508 and the first and second deformable portions 1512 and 1514 .
- a first set of tines 1534 extends outwardly of the first retaining member 1506 and into the opening 1532 .
- a second set of tines 1536 extends outwardly of the second retaining member 1508 and into the opening 1532 .
- the first and second sets of tines 1534 and 1536 are adapted to puncture tissue and, thus, each of the tines ends in a point, indicated as 1540 on one of the tines in FIG. 49 .
- the clip 1502 has an open condition shown in FIG. 49 and a closed condition.
- FIGS. 41 and 48 illustrate clips 870 and 1326 that are similar to clip 1502 in closed conditions.
- the opening 1532 of the clip 1502 is adapted to receive tissue.
- the first and second retaining portions 1506 and 1508 of the clip 1502 move together to clamp the tissue and occlude a wound.
- the first and second sets of tines 1534 and 1536 pierce the tissue that is received in the opening 1532 for retaining the clip to the tissue.
- the body portion 1504 of the clip 1502 may be planar in both the open condition and the closed condition.
- the body portion 1504 may also be planar during movement between the open and closed conditions. It should be understood by those of ordinary skill in the art that the configuration of the clip 1502 may be changed to be non-planar, such as by placing tines of the clip 1502 out of a plane of the body portion 1504 .
- FIGS. 39 and 40 illustrate a clip 870 that is similar to clip 1502 during movement between the open and closed conditions.
- FIGS. 46 and 47 illustrate a clip 1326 that is similar to clip 1502 during movement between the open and closed conditions. During movement between the open and closed conditions, the deformation zones 1528 and 1530 of the deformable portions 1512 and 1514 of the clip 1502 are deformed to enable movement within the plane of the body portion 1504 .
- FIG. 50 illustrates a second exemplary embodiment of a clip 1502 a.
- the clip 1502 a of FIG. 50 is similar to the clip 1502 of FIG. 49 and therefore, structures of FIG. 50 that are the same as or similar to those described with reference to FIG. 49 have the same reference numbers with the addition of the suffix “a”.
- the clip 1502 a of FIG. 50 is identical to the clip 1502 of FIG. 49 with the exception of the first and second sets of tines 1534 a and 1536 a .
- the first and second sets of tines 1534 a and 1536 a include fewer tines that the first and second sets of tines 1534 and 1536 of FIG. 49 .
- each tine of the first and second sets of tines 1534 a and 1536 a includes a tapered surface 1544 .
- the tapered surface 1544 sharpens the point 1540 a of each of the tines of the first and second sets of tines 1534 a and 1536 a.
- FIG. 51 illustrates a third exemplary embodiment of a clip 1502 b .
- the clip 1502 b of FIG. 51 is similar to the clip 1502 of FIG. 49 and therefore, structures of FIG. 51 that are the same as or similar to those described with reference to FIG. 49 have the same reference numbers with the addition of the suffix “b”.
- the clip 1502 b of FIG. 51 is identical to the clip 1502 of FIG. 49 with the exception of the first and second sets of tines 1534 b and 1536 b and the inclusion of locking devices 1548 .
- the first and second sets of tines 1534 b and 1536 b include fewer tines that the first and second sets of tines 1534 and 1536 of FIG. 49 .
- the clip 1502 b includes the locking devices 1548 for locking the clip in the closed condition.
- One locking device 1548 is associated with each of the first and second deformable portions 1512 b and 1514 b.
- Each locking device 1548 includes first and second toothed members 1550 and 1552 , respectively. When the clip 1502 b moves into the closed condition, the first and second toothed members 1550 and 1552 of the locking devices 1548 mesh together to lock the clip in the closed condition.
- FIG. 52 illustrates a fourth exemplary embodiment of the clip 1602 .
- the clip 1602 includes a planar body portion 1604 having first and second retaining portions 1606 and 1608 , respectively, and first and second deformable portions 1612 and 1614 , respectively.
- the first and second retaining portions 1612 and 1614 include docking features 1622 for enabling the first and second retaining portions to be docked onto a closing device.
- FIG. 52 illustrates the clip 1602 having a single tine 1626 that extends inwardly into the opening 1624 from the first retaining portion 1612 and a single tine 1628 that extends inwardly into the opening 1624 from the second retaining portion 1614 .
- the tines 1626 and 1628 are bent to extend at an angle of in the range of approximately twenty to ninety degrees relative to the planar body portion 1604 .
- the first deformable portion 1612 of the clip 1602 includes a single outwardly extending tine 1634 and four deformation zones 1636 , only two of which are labeled in FIG. 52 .
- the second deformable portion 1614 of the clip 1602 includes a single outwardly extending tine 1638 and four deformation zones 1640 , only two of which are labeled in FIG. 52 .
- Each of the deformation zones 1636 and 1640 of the clip 1602 has a width, measured within the plane of the body portion 1604 , that is less than a material thickness of the body portion, measured in a direction perpendicular to the plane of the body portion of the clip so as to enable the clip to remain planar during movement from an open condition to a closed condition.
- FIG. 53 illustrates a fifth exemplary embodiment of a clip 1602 a .
- the clip 1602 a of FIG. 53 is similar to the clip 1602 of FIG. 51 and therefore, structures of FIG. 53 that are the same as or similar to those described with reference to FIG. 52 have the same reference numbers with the addition of the suffix “a”.
- FIG. 53 illustrates the clip 1602 a having two tines 1626 a that extend inwardly into the opening 1624 a from the first retaining portion 1606 a and three tines 1628 a that extends inwardly into the opening from the second retaining portion 1608 a.
- the tines 1626 a and 1628 a are bent to extend at an angle of in the range of approximately twenty to ninety degrees relative to the planar body portion 1604 a.
- FIG. 54 illustrates a sixth embodiment of the clip 1702 .
- the clip 1702 includes a planar body portion 1704 that includes first and second retaining portions 1706 and 1708 , respectively, and first and second deformable portions 1712 and 1714 , respectively.
- the first and second deformable portions 1712 and 1714 of the clip 1702 include deformation zones 1720 .
- the first and second retaining portions 1706 and 1708 include expansion zones 1722 .
- the deformation zones 1720 and the expansion zones 1722 enable the body portion 1704 of the clip 1702 to remain planar during movement from an open condition to a closed condition.
- An opening 1726 in the clip 1702 is located between the first and second retaining portions 1706 and 1708 and the first and second deformable portions 1712 and 1714 .
- the first retaining portion 1706 of the clip 1702 includes a first set of tines 1728 that extends inwardly into the opening 1726 and a second set of tines 1730 that extends outwardly away from the opening.
- the second retaining portion 1708 of the clip 1702 includes a first set of tines 1734 that extends inwardly into the opening 1726 and a second set of tines 1736 that extends outwardly away from the opening. All of the tines 1728 , 1730 , 1734 , and 1736 of the clip 1702 extend radially relative to a center of the opening 1726 .
- the tines 1728 , 1730 , 1734 , and 1736 are bent to extend at an angle of in the range of approximately twenty to ninety degrees relative to the planar body portion 1704 .
- FIG. 55 illustrates a seventh exemplary embodiment of a clip 1702 a.
- the clip 1702 a of FIG. 55 is similar to the clip 1702 of FIG. 54 and therefore, structures of FIG. 55 that are the same as or similar to those described with reference to FIG. 54 have the same reference numbers with the addition of the suffix “a”.
- the clip 1702 a of FIG. 55 is identical to the clip 1702 of FIG. 54 with the exception that, the tines 1728 a , 1730 a , 1734 a , and 1736 a of the clip 1702 a extend parallel to one another and not radially relative to a center of the opening 1726 a. Again, prior to use, the tines 1728 a, 1730 a, 1734 a , and 1736 a are bent to extend at an angle of in the range of approximately twenty to ninety degrees relative to the planar body portion 1704 a.
- the clip 1802 of FIG. 56 includes tines 1804 that have planar ends 1808 .
- the clip 1812 of FIG. 57 has a bone-shape with lobed deformable portions 1814 and 1816 .
- the clip 1822 of FIG. 58 is oval.
- Each of the deformable portions 1824 and 1826 of the clip 1822 of FIG. 58 includes only a single deformation zone 1828 .
- the clip 1832 of FIG. 59 is oblong and, similar to the clip 1822 of FIG. 58 , includes only a single deformation zone 1834 in each deformable portion 1836 and 1838 .
- the tines of the clips 1802 , 1812 , 1822 , and 1832 of FIGS. 56-59 are bent to extend at an angle of in the range of approximately twenty to ninety degrees relative to the planar body portion.
- the clip 1902 of FIG. 60 includes a planar body portion 1904 having first and second retaining portions 1906 and 1908 , respectively, and first and second deformable portions 1910 and 1912 , respectively.
- a first set of tines 1914 extends outwardly from the first retaining portion 1906 .
- a second set of tines 1916 extends outwardly from the second retaining portion 1908 .
- a single 1920 tine extends outwardly of each of the deformable portions 1910 and 1912 .
- the tines 1914 , 1916 , and 1920 are bent so as to extend at an angle of in the range of approximately twenty to ninety degrees relative to the planar body portion 1904 of the clip 1902 .
- the tines 1914 and 1916 are bent to extend at a ninety degree angle relative to the planar body portion 1904 .
- the clip 2002 of FIG. 61 includes a planar body portion 2004 having first and second retaining portions 2006 and 2008 , respectively, and first and second deformable portions 2010 and 2012 , respectively.
- the first and second retaining portions 2006 and 2008 include docking features 2016 for enabling the first and second retaining portions to be docked onto a closing device.
- a first set of tines 2020 extends outwardly from and perpendicular to the first retaining portion 2006 .
- a second set of tines 2022 extends outwardly from and perpendicular to the second retaining portion 2008 .
- FIG. 62 illustrates a clip 2102 that includes a planar body portion 2104 having first and second retaining portions 2106 and 2108 , respectively, and first and second deformable portions 2110 and 2112 , respectively.
- the first and second retaining portions 2106 and 2108 include docking features 2116 for enabling the first and second retaining portions to be docked onto a closing device.
- a first set of tines 2120 extends outwardly from and perpendicular to the first retaining portion 2106 .
- a second set of tines 2122 extends outwardly from and perpendicular to the second retaining portion 2108 .
- the clip 2102 of FIG. 62 also includes two locking devices 2126 .
- Each locking device 2126 includes a barb 2128 and an associated receiving portion 2130 .
- the barb 2128 of each locking device 2126 pierces its associated receiving portion 2130 and locks in the associated receiving portion.
- FIG. 63 illustrates a fifteenth exemplary embodiment of a clip 1502 c.
- the clip 1502 c of FIG. 63 is similar to the clip 1502 of FIG. 49 and therefore, structures of FIG. 63 that are the same as or similar to those described with reference to FIG. 49 have the same reference numbers with the addition of the suffix “c”.
- the first and second deformable portions 1512 c and 1514 c , respectively, of the body portion 1504 c of the clip 1502 c of FIG. 63 are formed from a polymeric material that degrades after a predetermined time period for releasing the clip 1502 c from the tissue.
- the first and second deformable portions 1512 c and 1514 c are formed from an acetyl with a high starch concentration, preferably 10 to 20 percent. The starch absorbs moisture and degrades so that the clip 1502 c is released.
- the clip 1502 c is released in a period of approximately one to two weeks.
Abstract
A device for excising tissue and closing a wound that results from excision of the tissue includes structure defining an aperture into which tissue to be excised is exposed. The device also includes a cutting member for excising the tissue, a closure member for closing the wound, and an actuatable drive member associated with the structure. The drive member is actuatable to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture and for closing the wound with the closure member.
Description
- This application is a continuation-in-part of co-pending patent application Ser. No. 10/261,155, filed Sep. 30, 2002, which claims priority to provisional patent application No. 60/326,254, filed Oct. 1, 2001, and 60/357,520, filed Feb. 15, 2002.
- 1. Field of Invention
- The present invention relates to the excision of skin tags, moles, lesions and other types of discrete patches or points on the skin (herein collectively referred to as lesions) from a human or animal.
- 2. Description of the Related Art
- In 1996, the Center for Disease Control estimated that approximately 2 million skin lesions were excised (from humans) per year in the United States. This estimate was based on voluntary reporting by several centers and is most likely an underestimate of the actual number of skin lesions excised. In that same year, it was estimated that approximately 8 million skin lesions were excised (again, from humans) per year in industrialized nations worldwide.
- The current medical practice model for treatment of skin cancer involves preliminary screening of skin lesions. This requires surgical excision of the skin lesion typically done in the office of a plastic surgeon. Alternative methods by which dermatologists can biopsy lesions in screening for cancer include shaving small segments for microscopic analysis, or punch biopsy. A punch biopsy involves coring out a small sample of the skin lesion and then leaving the skin defect open with a covering bandage. Because it is such a small sample, no skin closure is used.
- When an individual identifies a mole or skin lesion that he or she wishes excised, either for cosmetic purposes or screening for skin cancer, the first approach is often a visit to the family practice physician or internist. At that time, evaluation of the lesion is performed and if necessary, referral to the dermatologist or plastic surgeon is given.
- Plastic surgeons or other physicians performing surgical excision typically prepare and drape the area, inject the area locally with an anesthetic such as lidocaine, and then perform a surgical excision using a scalpel. The skin is re-approximated and closed using suture material, which is sewn and then tied.
- These methods of skin lesion excision can be awkward, time consuming and inconvenient. Often patients fail to follow up with screening for skin lesions because of the inconvenience and fear of surgical procedures even though minor. A device and/or method of simply and effectively excising skin lesions while the underlying skin is simultaneously re-approximated and closed is highly desirable. Patients would then be more likely to follow through with the procedures and derive greater satisfaction overall. This would also lead to earlier detection of skin cancer when it is more easily treated.
- In accordance with the present invention, devices and methods are provided by which skin lesions are excised safely and effectively with substantially simultaneous closure of the skin. The excision and closure of the excision site through use of the present invention could change the paradigm for screening and treatment of skin cancer in the industrialized world.
- The inventive devices are quick and easy to manipulate, and the method requires only a minimum of local anesthesia or analgesia for patient comfort. The inventive methods could be performed in the office of the internist or family practice physician where the patient initially presents and often by a physician extender, such as a nurse practitioner, under the supervision and guidance of the physician.
- Through use of the present invention, it would be unnecessary for patients to make a secondary appointment with another physician for examination and potential excision of the lesion. The usual 30-minute procedure could be reduced to 2 or 3 minutes using the present invention. Moreover, the excised lesion may be easily retrieved from the inventive device and submitted for pathologic examination.
- The present invention also provides a device for excising tissue and closing a wound that results from excision of the tissue. The device comprises structure defining an aperture into which tissue to be excised is exposed, a cutting member for excising the tissue, a closure member for closing the wound, and an actuatable drive member associated with the structure. The drive member is actuatable to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture and for closing the wound with the closure member.
- The present invention also provides a method for excising tissue and closing a wound that results from excision of the tissue. The method comprises the steps of: exposing the tissue to be excised into an aperture formed in a structure; moving a portion of a drive member over a first distance to move a closure member into engagement with the tissue that is exposed in the aperture; moving the drive member over a second distance beyond the first distance so as to move a cutting member relative to the aperture for excising the tissue that is exposed in the aperture; and moving the drive member over a third distance beyond the second distance for closing the wound with the closure member.
- The present invention still further provides a method for excising tissue and closing a wound that results from excision of the tissue. The method comprises the steps of exposing the tissue to be excised into an aperture formed in a structure; moving a portion of a drive member over a first distance to move a closure member into a closed condition for clamping the tissue that is exposed in the aperture; moving the drive member over a second distance beyond the first distance so as to move a cutting member relative to the aperture for excising the tissue that is exposed in the aperture.
- The present invention also provides an exciser for excising tissue. The exciser comprises structure defining an aperture into which tissue to be excised is exposed, a cutting member for excising the tissue, and an actuatable drive member associated with the structure. The drive member is actuatable to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture. The exciser also comprises an actuator handle that is associated with the drive member. Movement of the actuator handle relative to the structure actuates the drive member.
- The present invention also provides a method of excising tissue. The method comprises the steps of: exposing tissue into an aperture defined in a structure; supporting a cutting member on an actuatable drive member that is movable relative to the structure; associating an actuator handle to the drive member; and moving the actuator handle to actuate the drive member to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture.
- The present invention also provides a closure member for clamping tissue adjacent a wound. The closure member comprises a planar body portion including first and second retaining portions and a deformable portion that connects the first and second retaining portions. The closure member has an open condition in which the deformable portion spaces the first and second retaining portions apart from one another so that the tissue to be clamped may be placed between the first and second retaining portions. The closure member also has a closed condition in which the deformable portion is elastically deformed to bring the first and second retaining portions together to clamp the tissue between the first and second retaining portions. The body portion of the closure member is planar in both the open and closed conditions. The closure member further includes a first set of tines that extends outwardly of the first retaining portion and a second set of tines that extends outwardly of the second retaining portion. The first and second sets of tines engage the tissue to secure the body portion to the tissue when the closure member is in the closed condition.
- The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
-
FIG. 1 is an oblique view of a first embodiment of the inventive device positioned against the skin of the patient and in a first state, prior to lesion excision, with the forceps retracted; -
FIG. 2 shows the device ofFIG. 1 in a second, sequential state, prior to lesion excision, with the forceps extended and capturing the lesion to be excised; -
FIG. 3 shows the device ofFIG. 1 in a third, sequential state, prior to lesion excision, with the forceps shown in a lesion-pulling position and the safety pin removed; -
FIG. 4 shows the device ofFIG. 1 in a fourth, sequential state, during lesion excision, with the staple partially closed through the skin surrounding the lesion; -
FIG. 5 shows the device ofFIG. 1 in a fifth, sequential state, during lesion excision, with the staple more fully closed; -
FIG. 6 shows the device ofFIG. 1 in a sixth, sequential state, after lesion excision, with the staple fully closed, the forceps being withdrawn from the device and removing the lesion from the skin; -
FIG. 7 shows the device ofFIG. 1 in a seventh, sequential state, after lesion excision, the device housing being removed from the skin, the forceps holding the excised lesion fully removed from the device housing; -
FIG. 8 is an enlarged fragmentary sectional view of the exciser ofFIG. 1 along line 8-8, showing the staple retention feature of the housing and the position of a lesion to be excised from the skin; -
FIG. 9 is an oblique view of a second embodiment of the inventive device located on the skin of the patient, assembled and in a first, open position; -
FIG. 10 is a view of the component parts of the device ofFIG. 9 in a disassembled state; -
FIG. 11 is an oblique view of the first applicator block of the device ofFIG. 9 , with the male staple half inserted therein; -
FIG. 12 is an oblique view of the second applicator block of the device ofFIG. 9 , with the female staple half inserted therein; -
FIG. 13 is an oblique view of the blade assembly of the device ofFIG. 9 ; -
FIG. 14 is an oblique view of the blade assembly ofFIG. 13 fitted to the second applicator block ofFIG. 12 ; -
FIG. 15 is a view of the male and female staple halves ofFIGS. 11 and 12 , respectively, shown interfitted; -
FIG. 16 shows the device ofFIG. 9 in a first state, prior to lesion excision; -
FIG. 17 shows the device ofFIG. 9 in a second, sequential state, prior to lesion excision and during interfitting of the staple halves; -
FIG. 18 shows the device ofFIG. 9 in a third, sequential state, prior to lesion excision but after closure of the staple; -
FIG. 19 shows the device ofFIG. 9 in a forth, sequential state, during lesion excision; -
FIG. 20 shows the device ofFIG. 9 in a fifth, sequential state, upon lesion excision; -
FIG. 21 shows the device ofFIG. 9 in a sixth, sequential state, after upon completion of the excision and during partial release of the closed staple from the device; -
FIG. 22 is an oblique view of a third embodiment of the inventive device; -
FIG. 23 is a sectional view of the device ofFIG. 22 in a fully opened state; -
FIG. 24 is a sectional view of the device ofFIG. 22 in a first state, prior to lesion excision, the integral tweezers or forceps of the device closed on the lesion to be excised; -
FIG. 25 shows the device ofFIG. 22 in a second, sequential state, prior to lesion excision and during closure of the staple halves through the skin surrounding the lesion; -
FIG. 26 shows the device ofFIG. 22 in a third, sequential state, subsequent to closure of the staple and during lesion excision; -
FIG. 27 shows the device ofFIG. 22 in a fourth, sequential state, subsequent to lesion excision and during removal of the excised lesion from the skin; -
FIG. 28 is a side view of a fourth embodiment of the inventive device in a fully opened state, with separate, known tweezers or forceps also shown; -
FIG. 29 shows the separate tweezers pulling the lesion away from the skin and the device ofFIG. 28 in a second, sequential state prior to lesion excision and during closure of the staple halves through the skin surrounding the lesion; -
FIG. 30 shows the device ofFIG. 28 in a third, sequential state, after closure of the staple and during lesion excision; -
FIG. 31 shows the device ofFIG. 28 in a fourth, sequential state, subsequent to lesion excision and during removal of the excised lesion from the skin with the tweezers; -
FIG. 32 is a disassembled view of a first embodiment of a two-piece staple for use with the inventive device ofFIG. 22 or 28, the staple pieces shown attached thereto; -
FIG. 33 is a disassembled view of a second embodiment of a two-piece staple for use with the inventive device ofFIG. 22 or 28, the staple pieces shown attached thereto. -
FIGS. 34 a-34 d schematically illustrate a sectional view a device constructed in accordance with a fifth embodiment of the present invention; -
FIG. 35 is an oblique view of a first exemplary device constructed in accordance with the fifth embodiment of the present invention; -
FIG. 36 is an oblique, exploded view of the device ofFIG. 35 ; -
FIG. 37 is a sectional view of the device ofFIG. 35 ; -
FIG. 38 is a plan view of a drive member of the device ofFIG. 35 in a first position relative to a base plate portion of the device; -
FIG. 39 is a plan view of the drive member in a second position relative to the base plate portion; -
FIG. 40 is a plan view of the drive member in a third position relative to the base plate portion; -
FIG. 41 is a plan view of the drive member in a fourth position relative to the base plate portion; -
FIG. 42 is an oblique view of a second exemplary device constructed in accordance with the fifth embodiment of the present invention; -
FIG. 43 is an oblique, exploded view of the device ofFIG. 42 ; -
FIG. 44 is a sectional view of the device ofFIG. 42 ; -
FIG. 45 is a plan view of a drive member of the device ofFIG. 42 in a first position relative to a base plate portion of the device; -
FIG. 46 is a plan view of the drive member in a second position relative to the base plate portion; -
FIG. 47 is a plan view of the drive member in a third position relative to the base plate portion; -
FIG. 48 is a plan view of the drive member in a fourth position relative to the base plate portion; -
FIG. 49 is a first exemplary embodiment of a closure member for use with the devices ofFIGS. 35 and 42 ; -
FIG. 50 is a second exemplary embodiment of a closure member; -
FIG. 51 is a third exemplary embodiment of a closure member; -
FIG. 52 is a fourth exemplary embodiment of a closure member; -
FIG. 53 is a fifth exemplary embodiment of a closure member; -
FIG. 54 is a sixth exemplary embodiment of a closure member; -
FIG. 55 is a seventh exemplary embodiment of a closure member; -
FIG. 56 is an eighth exemplary embodiment of a closure member; -
FIG. 57 is a ninth exemplary embodiment of a closure member; -
FIG. 58 is a tenth exemplary embodiment of a closure member; -
FIG. 59 is an eleventh exemplary embodiment of a closure member; -
FIG. 60 is a twelfth exemplary embodiment of a closure member; -
FIG. 61 is a thirteenth exemplary embodiment of a closure member; -
FIG. 62 is a fourteenth exemplary embodiment of a closure member; and -
FIG. 63 is a fifteenth exemplary embodiment of a closure member. - Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate various embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
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FIG. 1 showsexciser 10, a first embodiment of the present invention which includesbase assembly 12 andseparable forceps assembly 14. It is envisioned thatexciser 10 may be a single use device, all or part of which may be discarded after a lesion has been excised therewith. -
Base assembly 12 includes transparent, elongate plastic housing orframe 16 which, as shown, has the shape of a parallelepiped. If is envisioned, however, thathousing 16 may be of any suitable shape. The lower side ofhousing 16, that side which, in use, lies against skin S of the patient, is provided with rectangularfirst aperture 18 which frames lesion L to be excised. At a location directly oppositefirst aperture 18, the upper side ofhousing 16 is provided with circularsecond aperture 20 into which the end ofcylindrical body 22 offorceps assembly 14 is inserted. -
Forceps assembly 14 further includes forceps ortweezers 24 having a pair of elongate, separable, somewhat flexible arms which are retractable into and extendable from the interior ofcylindrical forceps body 22, andspring 26 which acts to urgetweezers 24 into theinterior body 22.Forceps assembly 14 is also provided withplunger 28 which, when depressed with the thumb, urgestweezers 24 out ofbody 22 against the action ofspring 26, the extended tweezers urged into an open position in which its arms are spread. Release ofplunger 28 allowsspring 26 to forcetweezers 24 upwardly and intobody 22, closing the tweezers. Those of ordinary skill in the art will recognize thatforceps assembly 14 may include a mechanism similar to slender, elongate tools commonly used by mechanics for grasping small parts such as screws and nuts, for example, which have been dropped into hard to reach places. Such grasping tools typically employ spring-biased tweezers which are opened by depression of a plunger, as described above. Alternatively,forceps assembly 14 may include a mechanism (not shown) by which tweezers 24 are similarly extended from a body and opened, or retracted into the body and closed, by turning a screw threaded into the body, the tip of the screw attached to the tweezers inside the body. As a further, unshown alternative,second aperture 20 may be enlarged, orhousing 16 otherwise adequately fashioned to allow the lesion to be manually captured with an ordinary pair of tweezers or forceps. - Disposed inside
housing 16, adjacent tofirst aperture 18, is a skin-closure device which may be made of a surgical stainless steel or a suitable plastic material:Unitary staple 30, in its opened condition, is somewhat V-shaped, having a pair of distant, splayed straight legs, 32 and 34, each having an end integrally connected tocentral portion 36 which extends between one end of the legs. The free, end oflegs barbs Staple 30 may be lightly adhered to the inside surface ofhousing 16 to help maintain its position prior to being closed. - The interfacing, or inward sides of
legs pins 42 which extend therefrom and which, when the staple is closed, are alternating relative to the legs from which they extend. When the staple is closed, and pins 42 extend through the skin below the excision site, the pointed free end of eachpin 42 abuts or is at least proximal the inward side of the opposite leg. It is to be understood thatstaple 30, and/or any of the other skin-closure devices or staples described further herein below, are exemplary embodiments which may be adapted for use with the inventive excisers. It is envisioned that other types of skin-closure devices which serve to close or maintain closed the skin at the lesion excision site may also be in accordance with the present invention, and such devices or the use thereof fall within the scope of the present invention. -
Housing 16 is provided with inverted U-shaped clip 43 (FIG. 8 ) which is integrally molded or otherwise attached thereto at the edge of rectangularfirst aperture 18nearest blade assembly 44.Clip 43 surrounds three sides of staplecentral portion 36 to prevent its movement longitudinally ofhousing 16 when engaged by the blade assembly, as disclosed further below. Notably, the opening ofclip 43 is located overfirst aperture 18 such that, upon removal ofbase assembly 12 from the skin of the patient after excision of the lesion,closed staple 30 may exit the housing with clearance between itscentral portion 36 and the adjacent edge offirst aperture 18. Note that excisers and skin-closure devices of different sizes may be provided to accommodate the excision various sized lesions and closure of skin at the excision site. - Also disposed within
housing 16 isblade assembly 44 which includessurgical steel blade 46 fixed between wedges or hammers 48 and 50.Hammers blade assembly 44 and are provided withsurfaces longitudinal axis 55 ofhousing 16. As will be described further hereinbelow, during actuation ofexciser 10, hammers 48 and 50 andblade 46 move coincidentally such that surfaces 52 and 54 slidably engagelegs legs blade 46. Notably, the sharp edge ofblade 46 is located adjacent tosurfaces legs axis 55 are squeezed together bysurfaces clip 43 is located well beneathblade 46 so that the clip will not interfere with the blade's movement. -
Blade assembly 44 further includesblock 56 to which hammers 48 and 50 andblade 46 are attached.Block 56 is provided withpost 58 which extends vertically and hole 60 (FIGS. 3-7 ) which extends laterally.Base assembly 12 is also provided with removableelongate safety pin 62 which, prior to actuation ofexciser 10, extends intohole 60 and throughhole 64 inhousing 16. -
Compression spring 66 is provided insidehousing 16, and has one end fixed relative to the housing; the other end abutsblock 56.Spring 66 thus urgesblade assembly 44 from its cocked position alongaxis 55 towardstaple 30. Withsafety pin 62 installed,blade assembly 44 is retained in its cocked position against the force ofcompression spring 66 and may not be inadvertently actuated or triggered. Withsafety pin 62 installed,blade assembly 44 thus may not be slidably moved withinhousing 16 alongaxis 55.Base assembly 12 also provided withplunger 68 which extends through the lateral wall ofhousing 16 and hashead 70, the depression of which triggers,blade assembly 44 oncesafety pin 62 has been removed. -
Plunger 68 is provided with J-shaped latching end or hook 72 which, in the blade assembly cocked position, partially, surroundspost 58, the free end ofhook 72 extending laterally in a direction perpendicular toaxis 55 and abutting the post. Depression ofplunger head 70 moves plunger 68 laterally such thatpost 58 is no longer captured withinhook 72 and, withsafety pin 62 removed,spring 66 will then immediately forceblade assembly 44 to move alongaxis 55 toward the lesion andstaple 30. - The operation of
exciser 10 will now be described with sequential reference toFIGS. 1-7 . Thebody 16 ofbase assembly 12 is placed against skin S of the patient such that lesion L to be excised is framed byaperture 18, andsafety pin 62 is removed. Referring toFIG. 2 ,plunger 28 offorceps assembly 14 is depressed againstspring 26 andtweezers 24 are extended into the interior ofhousing 16 and expand. The free ends oftweezers 24, which may be serrated for enhanced gripping ability, acquire or grab, the lesion and, with reference toFIG. 3 ,plunger 28 is released. Under the influence ofspring 26, tweezers 24 are at least partially retracted intocylindrical body 22 and pull the lesion upwardly throughaperture 18.Parallel lines body 16, andblade 46 lies and moves in aplane containing lines - Because
body 16 is transparent, the doctor or nurse practitioner can establish the desired elevated position of the lesion byfirst sighting lines forceps assembly 14, if and as necessary, such that perimeter P of lesion L, which may be irregularly shaped, is pulled to a position above the superposed lines, as best shown inFIG. 8 . So positioned, the lesion will, after actuation of the blade assembly, be placed in proximity toblade 46 which cuts the skin located outside lesion perimeter P. In adjustingforceps assembly 14, itsbody 22 may be moved relative tobase assembly housing 16, or itsplunger 28 may be pulled further upward, drawingtweezers 24 further intobody 22. Alternatively, as mentioned above, the lesion may be captured manually using an ordinary pair of tweezers or forceps and appropriately positioned prior to triggeringblade assembly 44. As a further alternative, the lesion may be captured with a skin hook (not shown) and appropriately positioned prior to triggering the blade. - Once the lesion is in its desired position within
housing 16,blade assembly 44 is triggered by depression ofplunger head 70. In immediate response to the free end ofplunger hook 72 sliding clear ofblock post 58,blade assembly 44 quickly moves alongaxis 55.Blade 46 passes below the free ends oftweezers 24 and through the skin outside of lesion perimeter P, slicing the lesion from the skin whilestaple 30 simultaneously closes the skin at a location below the excision site. During closure ofstaple 30, assurfaces hammers close legs staple legs - Referring to
FIGS. 5 and 6 , the flat interfacing and parallel surfaces ofhammers central portion 36 ofstaple 30 fits closely therebetween and when barbed ends 38 and 40 of the staple become interlocked, the staple will assume a rectangular shape which is smaller than the periphery of rectangularfirst aperture 18. Afterblade assembly 44 has traveled its entire distance alongaxis 55, the lesion will be fully excised from the skin andstaple 30 is completely closed.Base assembly 12 may then be removed from the patient's skin,closed staple 30 passing throughfirst aperture 18.Forceps assembly 14, still gripping the excised lesion, may then be withdrawn fromhole 20 ofhousing 16. InFIG. 7 ,forceps assembly 14 is shown having been completely and separably withdrawn frombase assembly 12 with the excised lesion captured between the ends oftweezers 24. The excised lesion may then be discarded or sent to a laboratory for biopsy or other analysis as appropriate. - It is envisioned that after approximately four days the excision wound will have sufficiently healed that
staple 30 may be removed.Staple 30 may be removed by cutting it, perhaps at itscentral portion 36, and peeling itslegs pins 42 therefrom. - Referring now to
FIGS. 9-21 , there is shown exciser 100, a second embodiment of the present invention which was prototyped and successfully used in animal experiments. -
Exciser 100 comprisesfirst applicator block 102 andsecond applicator block 104. Disposed between the applicator blocks isblade assembly 106.Guide rods 108 are fixed withinbores 110 provided infirst applicator block 102 and slidably extend throughbores 112 insecond applicator block 104. First and second applicator blocks 102 and 104 may be made of a polymeric material such as nylon, for example. -
Blade assembly 106 comprisesblock portion 114 andblade 116.Block portion 114 is made of a material similar to that of applicator blocks 102, 104, andblade 116 is surgical steel or suitable plastic material, likeblade 46 offirst embodiment exciser 10.Blade 116 is attached to blockportion 114 through means offastener 120 or by any other suitable means.Guide rods 108 slidably extend throughbores 118 provided in bladeassembly block portion 114. - The basic components of
exciser 100 and its associated skin-closure device are shown inFIG. 10 . Two-part staple 122 comprises interfittingmale half 124 andfemale half 126. Malestaple half 124 comprises a pair ofparallel rod portions 128, and femalestaple half 126 comprises a pair of similarly spacedparallel tube portions 130.Rod portions 128 each include extendingportion 132 and pointed engagingportion 134.Tube portions 130 each include extendingportion 136 and engagingportion 138. As further described hereinbelow, each solid engagingportion 134 of the male staple half slidably and interferingly engages its mating hollow engagingportion 138 of femalestaple half 124 during closure of the staple. When staple halves 124 and 126 are separated or less than fully seated,staple 122 is in its open condition, and when staple halves 124 and 126 are fully engaged,staple 122 is in its closed condition. The interference fit between engagingportions staple 122 remains in its closed condition after excision of the lesion. - Extending between and fixed to
rod portions 128 of malestaple half 124 iselongate leg 140, and extending between and fixed totube portions 130 of femalestaple half 126 iselongate leg 142. When fitted intoexciser 100, or whenstaple 122 is closed,legs tube portions legs pins 144, which correspond topins 42 offirst embodiment exciser 10 shown inFIGS. 1 through 8 .Pins 144 extend in the longitudinal directions of engagingportions staple 122 is closed, the pins of the male and female staple halves are misaligned such that they alternate along the legs, and the pointed tips of the pins of one staple half are in close proximity to the leg of the opposite staple half. Notably, whenstaple 122 is closed as shown inFIG. 15 , engagingportions 134 of malestaple half 124 extend beyond the engagingportion 138 of femalestaple half 126 and into the female staple half's tubular extendingportions 136. The distance betweenparallel legs staple 122 is closed may be limited by the length of female staplehalf engaging portion 138 relative to itsleg 142, i.e., the ends of engagingportions 136abut leg 140, thereby minimizing the distance between the staple legs. - Referring again to
FIG. 9 , it can be seen that prior to excision of lesion L from skin S, extendingportions holes portions 132 of malestaple half 124, and the male staple half is slid intofirst applicator block 102 until the interfacing surfaces of the first applicator block andleg 140 abut. Similarly, extendingportions 136 of femalestaple half 126 are slidably received inholes 148 provided insecond applicator block 104, with the interfacing surfaces of the second applicator block andleg 142 abutting. -
FIGS. 9 and 16 show exciser 100 loaded with astaple 122 and in its open condition, in whichlegs exciser 100 is placed onto skin S of the patient. Perimeter P of lesion L to be excised is framed betweenlegs engaging portions 134 of the malestaple half 124. Is it again noted that excisers and staples of different sizes may be provided to accommodate the excision various sized lesions and closure of the excision site. During operation ofexciser 100,first applicator block 102 is held stationary relative to the patient's skin andsecond applicator block 104 andblade assembly 106 are moved relative tofirst applicator block 102 alongguide rods 108. - Lesion L to be excised with
exciser 100 may be pulled away from skin S through a means of ordinary tweezers or forceps (not shown). Alternatively, the lesion may be captured and pulled away from the skin with a skin hook (not shown). Lesion L is pulled throughexciser 100, between the staple legs and the engaging portions of the male staple half, to an extent which places its perimeter P on the side of the plane defined byblade 116 opposite that on whichstaple 122 is located. This ensures that the entire lesion, and not just a portion thereof, will be excised byblade 116 and the staple will close the skin beneath the excision site by pinching together, betweenproximate legs staple 122 into ah elliptical shape, and the dermis of the skin, rather than merely the epidermis is brought into and held in abutting contact by the closed staple to promote faster healing. - Referring to
FIGS. 16-20 , the sequence of movements ofexciser 100 and its staple halves are shown sequentially. Prior to the cutting of the skin byblade 116, it can be seen (FIGS. 16-18 ), thatplanar blade 116 overliesflat surface 150 ofsecond applicator block 104 and thus cannot begin cutting engagement with me patient's skin untilblade assembly 106 is moved relative tosecond applicator block 104 alongguide rods 108. -
FIG. 17 shows thesecond applicator block 104 andblade assembly 106 having been moved together alongguide rods 108 towardfirst applicator block 102 such that engagingportions staple 122 has begun prior to any cutting byblade 116. -
FIG. 18 shows that further movement ofsecond applicator block 104 andblade assembly 106 together alongguide rods 108 towardfirst applicator block 102 has completely closedstaple 122, applicator blocks 102 and 104 being in their closest proximity to each other. Notably, unlikefirst embodiment exciser 10, in which excision of the lesion and closure of the excision site are done substantially simultaneously exciser 100 completely closesstaple 122 prior to any cutting byblade 116. Lesion L, which had previously been pulled outwardly away from the rest of the patient's skin by ordinary tweezers or forceps, is held in place such that its perimeter P is above the plane defined byflat blade 116 by the staple.Pins 144, which pierce the skin, support the lesion above the plane defined byflat blade 116; but the lesion may still be grasped by the tweezers or forceps for easy handling after excision. - Referring to
FIG. 19 , it can be seen that movement ofblade assembly 106 relative tosecond applicator block 104 alongguide rods 108 and towardfirst applicator block 102forces blade 116 over the closed staple and through the patient's skin, preferably outside of the perimeter of the lesion. Here it can be seen that asblade 116 is moved, it is received inrecess 152 formed infirst applicator block 102. - Referring to
FIG. 20 ,exciser 100 is shown in a position in which the lesion has been completely severed and perhaps removed from the excision site by the tweezers or forceps. In this position, the interfacing surfaces offirst applicator block 102 and bladeassembly block portion 114 abut, and further movement ofblade assembly 106 alongguide rods 108 away fromsecond applicator block 104 is prevented. - Finally, with reference to
FIG. 21 ,blade assembly 106 is reversely slid alongguide rods 108 back to its initial position relative tosecond applicator block 104, andsecond applicator block 104 andblade assembly 106 are held together.First applicator block 102 is moved away fromsecond applicator block 104 andblade assembly 106, withdrawingguide rods 108 therefrom. Extendingportions 132 ofstaple 122 are withdrawn fromholes 146 infirst applicator block 102. The position ofstaple 122 of course remains stationary relative to skinS. Extending portions 136 ofstaple 122 are then withdrawn fromholes 148 insecond applicator block 104 and the exciser completely removed from the patient. The extending portions ofstaple 122 may then be trimmed to reduce the size of the staple. As noted above, it is anticipated thatstaple 122 would remain in place for approximately four days while the excision site heals, after which the staple halves may be separated by pulling them apart, overcoming the interference fit between the engagingportions - Referring now to
FIGS. 22-27 there is shown exciser 200, a third embodiment of the present invention which is formed of elongate first andsecond halves handle portion jaw portion second halves rivets 214 to form a basic structure similar to an ordinary pair of pliers or clippers. Formed in first andsecond halves central recess 216, in which is disposedbarrel 218.Barrel 218 has the general form of a parallelepiped having closed sides and open ends. Opposite sides ofbarrel 218 are provided with holes through which rivets 214 extend, thereby securingbarrel 218 to the rest ofexciser 200. Extending through the open ends ofbarrel 218 are integral tweezers orforceps 220 comprising first and secondflexible arms Arms attached end 226 oftweezers 220. Fixed to attachedend 226 areshort rods 228 which are separated from and attached to each other throughneck 230.Rods 228 extend in directions parallel to the longitudinal axes ofrivets 214. -
Neck 230 extends throughslot 232 centrally provided in elongatespring steel strip 234, the opposite ends 236 of which are pivotally attached to first and second exciser halves 202 and 204. Spring steel strip is plastically deformed at its center, and retains and controls longitudinal movement of integral tweezers orforceps 220 through the engagement ofrods 228 with the portions ofstrip 234 on opposite sides ofslot 232. - First and
second arms tweezers 220 are provided with plasticallydeformed portions 238 which, whentweezers 220 are longitudinally moved in the direction ofarrow 252, causes the opposed free ends 240 of first andsecond arms forceps 220 capture the lesion to be excised, and longitudinal movement oftweezers 220 in the direction ofarrow 252 pulls the lesion to be excised away from the skin. -
Jaw portions edges 242 which, when the jaws are closed, move towards each other and, when the jaws are fully closed, abut each other. Thus, skin located outside perimeter P of lesion L to be excised is pinched betweenblades 242 and cut from the remainder of the skin thereby.Blades 242,jaw portions halves entire exciser 200 may be made of surgical stainless steel. - Near the free ends of
jaw portions flat surfaces 244 to which are adhered first and secondseparate staple halves staple 250, another embodiment of a skin-closure device in accordance with the present invention. When staple halves 246 and 248 are separated or at least not fully engaged,staple 250 has an open condition. First and second staple halves 246 and 248 are, and thus staple 250 is, closed through manipulation ofexciser 220 which interlocks the staple halves to each other. With the staple halves in this fully engaged state, the staple has a closed condition. - The operation of
exciser 200 is now discussed with reference toFIGS. 24-27 . In a first state shown inFIG. 24 , free ends 240 of the integral tweezers or forceps capture lesion L to be excised from skin S, and the lesion is pinched therebetween as handleportions - In a second, sequential state shown in
FIG. 25 , further movement ofhandle portions spring steel strip 234 to flex and its center to move in the direction ofarrow 252, which forcestweezers 220 in that direction. Movement tweezers 220 upward in the direction ofarrow 252 bringsdeformed portions 238 of first andsecond arm barrel 218 and forces free ends 240 of the first andsecond arms portions past blades 242, staple halves 246 and 248 enter engagement with the skin outside of perimeter P and with each other in the manner disclosed further hereinbelow. - In a third sequential state shown in
FIG. 26 , handleportions arrow 252. In this state,staple 250 is fully closed, andblades 242 are brought into abutting engagement with each other, severing lesion L from skin S below lesion perimeter P. Althoughstaple 250 may achieve its fully closed condition prior to actual engagement ofblades 242 with skin S, the closing of the staple and the excision of lesion L may alternatively occur substantially simultaneously. - In a fourth sequential state shown in
FIG. 27 ,exciser 200, with excised lesion L still captured between tweezer free ends 240, is removed from the patient,staple 250 having closed skin S below the excision site such that the dermis located on opposite sides of the excision site are in abutting contact and an elliptically-shaped closure wound is formed as described above. The adhesive, which holdsstaple halves flat surfaces 244 of the staple-engaging portions at the free ends of the exciser jaws, breaks free upon slight release ofhandle portions spring steel strip 232, andexciser 200 can then be freely removed, leavingstaple 250 behind. Ashandle portions tweezers 220 move in a direction opposite toarrow 252, allowing free ends 240 to separate, freeing excised lesion L. - Referring now to
FIGS. 28-31 there is shown exciser 300, a fourth embodiment of a device according to the present invention, in a series of sequential states of operation.Exciser 300, likeexciser 200 has a basic structure similar to that of an ordinary pair of pliers or clippers, and a common skin-closure device may be used with these exciser embodiments. -
Exciser 300 has a pair of elongate first andsecond halves handle portion jaw portion halves pin 314. Rather than being provided with integral tweezers or forceps, asexciser 200 is,exciser 300 is used with separate, known tweezers orforceps 320 as shown.Tweezers 320 are used to capture and pull lesion L away from the skin S of the patient prior to moving handleportions exciser 300 are substantially identical to those ofexciser 200. -
Exemplary tweezers 320 have first andsecond arms attached end 326. With the ends ofjaw portions exciser 300. Once the captured lesion has been pulled intojaw portions blades 342, handleportions staple halves staple 250 are brought into engagement with the skin outside the outer perimeter of the lesion L and with each other, as shown inFIG. 29 . - In
FIG. 30 ,staple 250 is fully closed on skin S andblades 342 sever lesion L from skin S at a location outside lesion perimeter P, as described above. As noted above, althoughstaple 250 may achieve its fully closed condition prior to actual engagement ofblades 342 with skin S, the closing of the staple and the excision of lesion L may alternatively occur substantially simultaneously. The lesion held bytweezers 320 is then removed from the excision site. InFIG. 31 , the jaws ofexciser 300 are separated, causing the adhesive, which heldstaple halves flat surfaces 344 of the staple-engaging portions of the jaws, to break free. The resulting elliptically-shaped excision wound, in which the dermis located on opposite sides of the excision is held in abutting contact bystaple 250, is substantially identical to that resulting from use ofexciser 200. - Referring now to
FIGS. 32 and 33 , there are respectively shownstaples 250 a and 250 b, first and second embodiments ofstaple 250 which can be used with either of above-describedexcisers staples 250 a and 250 b are identified with a common reference numeral, whereas corresponding elements ofstaples 250 a and 250 b are identified alphanumerically with a common numeric portion an alphabetic character (a or b) which correlates with aparticular embodiment staple 250 a or 250 b. Each embodiment ofstaple 250 comprisesstaple halves flat surfaces jaw portions excisers - Each
staple half 246 is provided with elongate flatcentral portion 360 extending betweenlegs 362 and 364. A suitable releasable adhesive 366, which is later broken free during removal of the exciser from the patient as described above, is provided between the outer planar surface of flatcentral portion 360 and theabutting surface jaw portion - Similarly, each
staple half 248 is provided with elongate flatcentral portion 370 extending between legs 372 and 374,staple half 248 being releasably adhered to itsmating jaw surface - Pointed pins 368 extend from the inner planar sides of flat
central portions staple 250 is closed, the terminal ends of pins 368 of one staple half abut the interfacing inner surface of the other staple half. Further, withstaple 250 closed, the pins alternate along the staple length on the basis of which staple half they extend from. Moreover, eachstaple half central portion flat surfaces legs 362 and 364 ofstaple half 246, or the locations of legs 372 and 374 ofstaple half 248 may be switched relative to the exciser. - Referring to
FIG. 32 , the ends oflegs 362 a and 364 a are provided withbarbs 376 which, when staple 250 a is closed, are interconnected withbarbs 378 provided at the ends oflegs 372 a and 374 a, the interconnecting barbs holding staple 250 a in its closed condition. The interconnection ofbarbs - Referring to
FIG. 33 , the legs 362 b and 364 b are substantially tubular and telescopically engagelegs 372 b and 374 b, which are interference fitted therein during closure ofstaple 250 b to maintain its closed condition. The engaging surfaces oflegs 362 b, 364 b and 372 b, 374 b may be smooth, their sliding interference fit being substantially as disclosed above with respect torod portions 128 andtube portions 130 ofstaple 122 of second embodiment exciser 100 (seeFIG. 15 ). -
Staple halves legs 372 b, 374 b provided withribs 380, as shown inFIG. 33 , which are compressed as they are forced into smooth-walled hollow legs 362 b, 364 b, the compression ofribs 380 providing a secure interference fit between the interconnected legs. As shown inFIG. 33 , the interior surfaces of hollow legs 362 b and 364 b may be also provided withrecesses 382 into whichribs 380 are received aslegs 372 b, 374 b are forced therein, the interfitting engagement ofribs 380 and recesses 382holding staple 250 b in its closed condition. -
FIGS. 34 a-34 d schematically illustrate a sectional view adevice 410 constructed in accordance with a fifth embodiment of the present invention. Thedevice 410 may be used for excising tissue and closing a wound that results from excision of the tissue.FIGS. 34 a-34 d schematically illustrate thedevice 410 excising alesion 412 fromskin 414. - The
device 410 includes ahousing 418. Anaperture 420 extends vertically through thehousing 418. Thedevice 410 also includes a cuttingmember 422 and a clampingmember 424. At least oneactuator 426 is movable relative to thehousing 418 for moving the cuttingmember 422 and for closing theclosure member 424. An optional second actuator that cooperates with theactuator 426 for closing theclosure member 424 is shown by dashed lines at 428 inFIGS. 34 a-34 d. - to remove the
lesion 412 from theskin 414, thehousing 418 is positioned relative to theskin 414 so that thelesion 412 is located directly below theaperture 420. As is shown inFIG. 34 a, thelesion 412 is pulled through theaperture 420 of thehousing 418 using askin hook 432 or other suitable device for grabbing thelesion 412. When thelesion 412 is pulled through theaperture 420, theskin 414 adjacent thelesion 412 is tensioned. - Next, as is shown in
FIG. 34 b, theactuator 426 of thedevice 410 is moved relative to thehousing 418. Movement of theactuator 426 causes theclosure member 424 to begin to close. As theclosure member 424 begins to close, tines (not shown) of theclosure member 424 pierce the tensionedskin 414 and the closure member begins to pinch the skin adjacent thelesion 412. - As shown in
FIG. 34 c, further movement of theactuator 426 relative to thehousing 418 causes the cuttingmember 422 to begin excising thelesion 412 from theskin 414. When thelesion 412 is completely removed from theskin 414, as shown inFIG. 34 d, further movement of theactuator 426 closes theclosure member 424 to close a wound that results from excision of thelesion 412. Alternatively, theclosure member 424 may be closed prior to the cuttingmember 422 completely removing thelesion 412 from theskin 414. The following description with reference toFIGS. 35-48 will describe two devices constructed in accordance with the fifth embodiment of the present invention. -
FIG. 35 is an oblique view of a firstexemplary device 510 constructed in accordance with the fifth embodiment of the present invention.FIG. 36 is an exploded oblique view of thedevice 510 andFIG. 37 is a sectional view of thedevice 510. Thedevice 510 includes ahousing 512 having abase plate portion 514 and atop plate portion 516. - The
base plate portion 514 of thehousing 512 includes lower andupper surfaces FIG. 37 , acavity 536 extends upwardly into thelower surface 520 of thebase plate portion 514. Thecavity 536 is generally elliptical and terminates at an upper surface 538 (FIG. 37 ). Anelliptical aperture 540 extends through thebase plate portion 514 and into thecavity 536. - As best shown in
FIG. 36 , afirst recess 544 extends downwardly into theupper surface 522 of thebase plate portion 514. As will be described in detail below, thefirst recess 544 receives adriver 640 of thedevice 510. Thefirst recess 544 includes a generally planarbottom surface 546. - The
first recess 544 includes a narrow section having laterally opposite side surfaces 558 and 560.Corners first recess 544. As will be discussed below, the location of thecorners - As shown in
FIG. 36 , another section of thefirst recess 544 is located between laterally opposite side surfaces 582 and 584. A protrudingportion 586 that includes theelliptical aperture 540 extends upwardly into thefirst recess 544 in a location between the side surfaces 582 and 584. Twoelongated slots first recess 544 to thecavity 536 on longitudinally opposite ends of the protrudingportion 586. - Two pivot pin holes 592 and 594 and a
second recess 600 extend into thebottom surface 546 of thefirst recess 544. The pivot pin holes 592 and 594 are located in theslot 590 and acurved end surface 596 of thefirst recess 544. Thesecond recess 600 extends longitudinally through a center of thefirst recess 544. Two axially extendingribs 602 extend into thesecond recess 600 near thecurved end surface 596 of thefirst recess 544. Theribs 602 form three elongated slots in thesecond recess 600. - The
base plate portion 514 also includes four fastener holes 604. The fourfastener holes 604 extend between the lower andupper surfaces base plate portion 514. - The
top plate portion 516 of thehousing 512 also a lower surface 610 (FIG. 37 ) and an upper surfaces 612 (FIG. 36 ). Anelliptical aperture 621 extends through thetop plate portion 516 of thehousing 512. Theelliptical aperture 621 extends between the lower andupper surfaces elliptical aperture 540 of thebase plate portion 514. Theupper surface 612 of thetop plate portion 516 is chamfered adjacent theelliptical aperture 621. - Four fastener holes 622 and two pivot pin holes 624 and 626 also extend through
top plate portion 516 between the lower andupper surfaces fastener holes 622 is associated with and has a location corresponding to afastener hole 604 of thebase plate portion 514 of thehousing 512. Each of the fastener holes 622 is located in acircular boss 628 that extends upwardly above theupper surface 612 of thetop plate portion 516. Each of the two pivot pin holes 624 and 626 is associated with and has a location corresponding to apivot pin hole base plate portion 514 of thehousing 512. - Two longitudinally
elongated slots top plate portion 516. Theslot 634 has a length and width of approximately four times the length and width of theslot 632. - The
device 510 also includes adriver 640.FIG. 36 illustrates an oblique view of thedriver 640 andFIGS. 38-41 illustrate a plan view of the driver located in thefirst recess 544 of thebase plate portion 514 of thehousing 512. For clarity in viewing thedriver 640 inFIGS. 38-41 , the protrudingportion 586 of thebase plate portion 514 that includes theelliptical aperture 540 is not shown. - The
driver 640 is injection molded from a plastic material that is flexible enough to allow for a living hinge to be formed on the driver. Exemplary plastic materials include nylon, polycarbonate, polyester, or any other suitable polymer. Thedriver 640 includes ayoke portion 642 and a drivingportion 644. Theyoke portion 642 of thedriver 640 includes longitudinally spaced first andsecond end portions second side portions central opening 658. - As shown in
FIG. 38 , the first andsecond side portions yoke portion 642 of thedriver 640 connect the first andsecond end portions second end portion 652 includes first and secondpivotal drive portions second side portions FIG. 38 , apivot pin hole 692 extends through the firstpivotal drive portion 680 and apivot pin hole 708 extends through the secondpivotal drive portion 682. - The
yoke portion 642 of thedriver 640 also includes proximal and distal engagingmembers member 714 extends into thecentral opening 658 from thefirst end portion 650. The proximal engagingmember 714 includes a recessed end portion 734 (FIG. 37 ). The distal engagingmember 716 is interposed between the first and secondpivotal drive portions member 716 also includes a recessed end portion 770 (FIG. 37 ). - The driving
portion 644 of thedriver 640 is located longitudinally opposite thefirst end portion 650 of theyoke portion 642 from thecentral opening 658. The drivingportion 644 includes ablade support portion 778, and first and secondcollapsible legs - The
blade support portion 778 includes circular boss 790 (FIG. 38 ) that extends upwardly from theblade support portion 778. A rectangular protrusion (not shown) extends downwardly from theblade support portion 778 for being received in thesecond recess 600 of thebase plate portion 514. - The first and second
collapsible legs blade support portion 778. The first and secondcollapsible legs blade support portion 778 and thefirsts end portion 650 of theyoke portion 642. The firstcollapsible leg 782 includes first andsecond leg portions second leg portions blade support portion 778 and thefirst end portion 650 of theyoke portion 642. The secondcollapsible leg 784 includes first andsecond leg portions second leg portions blade support portion 778 and thefirst end portion 650 of theyoke portion 642. - With reference again to
FIG. 36 , thedevice 510 also includes a cutting member orblade 830. Theblade 830 includes anaperture 836 that is sized for receiving thecircular boss 790 that extends upwardly from theblade support portion 778 of the drivingportion 644 of thedriver 640. Theblade 830 also includes a sharpenededge 838. Theblade 830 is formed from surgical steel. In one embodiment of the invention, theblade 830 is formed from 440 stainless steel. - The
device 510 also includes anactuator handle 844. The actuator handle 844 is molded from plastic. Anaperture 846 extends through theactuator handle 844 for receiving thecircular boss 790 that extends upwardly from theblade support portion 778 of the drivingportion 644 of thedriver 640 and afastener 848 that fixes theactuator handle 844 to theboss 790. - To assemble the
device 510, thedriver 640 is placed in thefirst recess 544 of thebase plate portion 514 of thehousing 512 so that thecentral opening 658 of theyoke portion 642 of the driver receives the protrudingportion 586 of the base plate portion. When thedriver 640 is located in thebase plate portion 514 of thehousing 512, the proximal and distal engagingmembers slots base plate portion 514 and slightly into the cavity 536 (FIG. 37 ) in thelower surface 520 of thebase plate portion 514. - The
blade 830 is then placed on the drivingportion 644 of thedriver 640 so that thecircular boss 790 extends through theaperture 836 in the blade. Theblade 830 is also received in thefirst recess 544 of thebase plate portion 514. The side surfaces 558 and 560 of thefirst portion 550 of thefirst recess 544 prevent theblade 830 from rotating about thecircular boss 790 and relative to thebase plate portion 514. - The
top plate portion 516 of thehousing 512 is placed over thebase plate portion 514 of the housing. Theslot 634 of thetop plate portion 516 receives thecircular boss 790 of theblade support portion 778 of the drivingportion 644 of thedriver 640. Theslot 632 of thetop plate portion 516 receives a portion of the distal engagingmember 716. When thetop plate portion 516 is properly positioned relative to thebase plate portion 514, the pivot pin holes 624 and 626, the fastener holes 622, and theelliptical aperture 621 of thetop plate portion 516 are in locations corresponding to the pivot pin holes 592 and 594, fastener holes 604, and theelliptical aperture 540 of thebase plate portion 514. Also, the pivot pin holes 692 and 708 of the first andsecond drive portions second end portion 652 of theyoke portion 642 of thedriver 640 are aligned with the pivot pin holes 592 and 594 of thebase plate portion 514 and the pivot pin holes 624 and 626 of thetop plate portion 516. - Four fasteners 854 (
FIG. 35 ) are then inserted through the fastener holes 622 of thetop plate portion 516 and the fastener holes 604 of thebase plate portion 514 to hold the top plate portion relative to the base plate portion. Afirst pivot pin 856 is inserted through thepivot pin hole 624 of thetop plate portion 516, thepivot pin hole 692 in the firstpivotal drive portion 680 ofsecond end portion 652 of theyoke portion 642, and thepivot pin hole 592 in thebase plate portion 514 of thehousing 512. Asecond pivot pin 858 is inserted through thepivot pin hole 626 of thetop plate portion 516, thepivot pin hole 708 in the secondpivotal drive portion 682 ofsecond end portion 652 of theyoke portion 642, and thepivot pin hole 594 in thebase plate portion 514 of thehousing 512. - The
aperture 846 in theactuator handle 844 is aligned with thecircular boss 790 of theblade support portion 778 of the drivingportion 644 of thedriver 640. The actuator handle 844 is pressed onto thecircular boss 790 and afastener 848 is inserted into theaperture 846 to lock the actuator handle to the boss. When theactuator handle 844 is placed on thecircular boss 790, thecircular boss 790 is located at a first end of theslot 634. - After assembly of the
device 510 is complete, thedevice 510 is turned over so that aclip 870 may be attached to the device. Exemplary clips are illustrated inFIGS. 49-63 and will be discussed later in this application. Theclip 870 ofFIG. 37 includes opposite first and second retainingportions - To attach the
clip 870 to thedevice 510, theclip 870 is placed in thecavity 536 that extends into thelower surface 520 of thebase plate portion 514. Thefirst retaining portion 872 of theclip 870 is placed on the recessedend portion 734 of the proximal engagingmember 714 and thesecond retaining portion 874 of theclip 870 is placed on the recessedend portion 770 of the distal engagingmember 716. - To use the
device 510 for removing a lesion or other portion of tissue, thelower surface 520 of thebase plate portion 514 of thehousing 512 of the assembleddevice 510, to which theclip 870 has been attached, is placed against the patient's tissue so that theelliptical apertures elliptical apertures housing 512 and hooks the portion of tissue. The portion of tissue is pulled through theclip 870 and theelliptical apertures housing 512 so that the tissue is placed under tension. - Pushing the
actuator handle 844 through theslot 634 toward theelliptical aperture 621 actuates thedevice 510. When theactuator handle 844 begins to move toward theelliptical aperture 621, the first and secondcollapsible legs first recess 544 in thebase plate portion 514, as is shown inFIG. 38 . As a result, the first and secondcollapsible legs yoke portion 642 of thedriver 640 begin to close theclip 870 so that tines of the clip penetrate the tissue and the clip begins to pinch the tissue. The first andsecond drive portions yoke portion 642 of thedriver 640 rotate to move the distal engagingmember 716 by an amount equal to the movement of the proximal engagingmember 714 to begin to close theclip 870.FIG. 39 illustrates thedevice 510 at a position in which theclip 870 begins to close. - Adjusting the location of the
corners blade 830 and clamping the tissue with theclip 870 to be controlled. The longitudinal lengths of side surfaces 558 and 560, illustrates inFIG. 38 as distance X, controls the timing of when the first and secondcollapsible legs portion 644 begin to collapse. Thus, by adjusting the distance X, thedevice 510 timing for cutting the tissue with theblade 830 and clamping the tissue with theclip 870 may be adjusted. For example, when the distance X is increased, theyoke portion 642 of thedriver 640 will close theclip 870 prior to the drivingportion 644 moving theblade 830 to cut the tissue. - When the first and second
collapsible legs portion 644 of thedriver 640 move out of contact with the side surfaces 558 and 560 and overcorners collapsible legs FIG. 39 . When the first and secondcollapsible legs blade support portion 778 begins to move toward thefirst end portion 650. During the movement of theblade support portion 778 toward thefirst end portion 650, theblade 830 cuts through the tissue that extends through theelliptical aperture 621 of thetop plate portion 516 to excise the tissue from the tissue that extends through theelliptical aperture 540 of thebase plate portion 514. - The tissue that extends into
elliptical aperture 540 remains pinched between the first and second retainingportions clip 870. After theblade support portion 778 of the drivingportion 644 of thedriver 640 contacts thefirst end portion 650 of theyoke portion 642 of the driver, as is shown inFIG. 40 , further movement of theactuator handle 844 through theslot 634 toward theelliptical aperture 621 results in movement of the proximal engagingmember 714 toward the center of theelliptical aperture 540 and equal movement of the distal engagingmember 716 toward the center of theelliptical aperture 540. The proximal and distal engagingmembers actuator handle 844 is moved through theslot 634 toward theelliptical aperture 621. When the proximal and distal engagingmembers portions clip 870 are pressed together into the position shown inFIG. 41 . When theactuator handle 844 reaches the end of theslot 634, theclip 870 fully occludes the wound that results from the excision of the tissue. - After the
clip 870 fully occludes the wound, theactuator handle 844 is moved in theslot 634 in a direction away from theelliptical aperture 621. Movement of theactuator handle 844 away from theelliptical aperture 621 causes the proximal and distal engagingmember clip 870. As an alternative to manually moving theactuator handle 844 to remove theclip 870, thedevice 510 may be modified to include a biasing member or spring (not shown) that biases thefirst end portion 650 of theyoke portion 642 of thedriver 640 relative to thebase plate portion 514 to remove theclip 870 from the proximal and distal engagingmember driver 640. - Preferably, all of the parts of the
device 510, with the exception of theblade 830 and theclip 870, are molded from plastic material. In a preferred embodiment, thedevice 510 is a single use device that is discarded after its use, while theclip 870 remains attached to the skin to close the wound. -
FIG. 42 is an oblique view of a second exemplary device constructed in accordance with the fifth embodiment of the present invention.FIG. 43 is an exploded oblique view of thedevice 1010 andFIG. 44 is a sectional view of thedevice 1010. - The
device 1010 includes ahousing 1012 having abase plate portion 1014 and atop plate portion 1016. Thebase plate portion 1014 of thehousing 1012 includes a lower surface 1020 (FIG. 44 ) and an upper surfaces 1022 (FIG. 43 ). A cavity 1034 (FIG. 44 ) extends upwardly into thelower surface 1020 of thebase plate portion 1014. Thecavity 1034 terminates at anupper surface 1036. Anelliptical aperture 1038 extends through thebase plate portion 1014 through theupper surface 1036 of thecavity 1034. - With reference to
FIG. 43 , afirst recess 1044 extends downwardly into theupper surface 1022 of thebase plate portion 1014. Thefirst recess 1044 includes a generallyplanar bottom surface 1046. A protrudingportion 1056 having theelliptical aperture 1038 extends upwardly from thebottom surface 1046 of thefirst recess 1044. As shown inFIG. 44 ,elongated slots portion 1056 and connect thefirst recess 1044 to thecavity 1034. - The
first recess 1044 includes a narrowed section having laterallyopposite side surfaces FIG. 45 ,corners opposite side surfaces first recess 1044. As will be discussed below, the location of thecorners - The
first recess 1044 also includes a generally elliptical section that includes arcuate side surfaces 1068 and 1070. The arcuate sides surfaces 1068 and 1070 are located on laterally opposite sides of the protrudingportion 1056. - A second recess 1080 extends downwardly into the
bottom surface 1046 of thefirst recess 1044. The second recess 1080 extends longitudinally through a center of thefirst recess 1044. - The
base plate portion 1014 also includes fourfastener holes 1082. The fourfastener holes 1082 extend between the lower andupper surfaces base plate portion 1014. - The
top plate portion 1016 of thehousing 1012 also includes a lower surface 1088 (FIG. 44 ) and anupper surfaces 1090. Arecess 1102 extends into theupper surface 1090 of thetop plate portion 1016. Therecess 1102 has aplanar bottom surface 1104. Anelliptical aperture 1116 extends through thetop plate portion 1016 of thehousing 1012. Theelliptical aperture 1116 extends between thebottom surface 1104 of therecess 1102 and thelower surface 1020 of thetop plate portion 1016. Theelliptical aperture 1116 has a location corresponding theelliptical aperture 1038 of thebase plate portion 1014. - Four
fastener holes 1118 extend throughtop plate portion 1116 between the lower andupper surfaces fastener holes 1118 is associated with and has a location corresponding to afastener hole 1082 of thebase plate portion 1014 of thehousing 1012. - Two axially
elongated slots top plate portion 1016. Theslots top plate portion 1016 from longitudinally opposite ends of the top plate portion. - The
device 1010 also includes adriver 1130.FIG. 45-48 illustrate plan views of thedriver 1130 in thebase plate portion 1014 of thehousing 1012. For clarity in viewing thedriver 1130 inFIGS. 45-48 , the protrudingportion 1056 of thebase plate portion 1014 that includes theelliptical aperture 1038 is not shown. - The
driver 1130 is injection molded from plastic material and includes ayoke portion 1132 and acutting portion 1134. Theyoke portion 1132 of thedriver 1130 includes opposite first andsecond end portions collapsible legs central opening 1148 extends between the first andsecond end portions collapsible legs - As shown in
FIG. 45 , the first and secondcollapsible legs second end portions collapsible leg 1144 includes first andsecond leg portions 1162 and 1164, respectively. Living hinges connect the first andsecond leg portions 1162 and 1164 to one another and to the first andsecond end portions collapsible leg 1146 also includes first andsecond leg portions second leg portions second end portions - The
yoke portion 1132 of thedriver 1130 also includes proximal and distal engagingmembers member 1208 extends longitudinally outwardly of thefirst end portion 1140 and into thecentral opening 1148. The proximal engaging member includes a recessed end portion 1218 (FIG. 44 ). The distal engagingmember 1210 also extends longitudinally into thecentral opening 1148. The distal engaging member includes a recessed end portion 1230 (FIG. 44 ). - The cutting
portion 1134 of thedriver 1130 is located longitudinally opposite thefirst end portion 1140 of theyoke portion 1132 from thecentral opening 1148. As shown inFIG. 43 , the cuttingportion 1134 includes ablade support portion 1238 and first and secondcollapsible legs circular aperture 1260 extends through theblade support portion 1238. A rectangular protrusion extends downwardly from theblade support portion 1238 for being received in the second recess 1080 of thebase plate portion 1014. - The first and second
collapsible legs blade support portion 1238 and thefirst end portion 1140 of the clamping portion 1232. The firstcollapsible leg 1240 includes first and second leg portions 1266 and 1268, respectively. Living hinges connect the first and second leg portions 1266 and 1268 together and to theblade support portion 1238 and thefirst end portion 1140. The secondcollapsible leg 1242 also includes first andsecond leg portions second leg portions blade support portion 1238 and thefirst end portion 1140. - As shown in
FIG. 43 , thedevice 1010 also includes a cutting member orblade 1290. Theblade 1290 includes anaperture 1296 and a sharpenededge 1298. Theblade 1290 is formed from surgical steel. In one embodiment of the invention, the blade is formed from 440 stainless steel. - The
device 1010 also includes first and second actuator handles 1304 and 1306, respectively. The actuator handles 1304 and 1306 are molded from plastic. Anaperture 1308 extends vertically throughactuator handle 1304. Likewise, anaperture 1310 extends vertically throughactuator handle 1306. - The
device 1010 also includes sixfastener 1314 and two blind nuts 1316. Thefasteners 1314 illustrated inFIG. 43 are screws having associated washers 1318. Alternatively, snap features may be incorporated into the various structures of thedevice 1010. The sixfasteners 1314 include four housing fasteners and two actuator fasteners. Each of the twoblind nuts 1316 includes acircular boss 1320 and aplanar base 1322. Theplanar bases 1322 of theblind huts 1316 are sized for being received in the second recess 1080 of thebase plate portion 1014 of thehousing 1012. - To assemble the
device 1010, acircular boss 1320 of one of theblind nut 1316 is inserted into theaperture 1260 of theblade support portion 1238 of thedriver 1130 so that the circular boss extends upwardly beyond an upper surface of the blade support portion. Thecircular boss 1320 of the otherblind nut 1316 is inserted into anaperture 1202 of thesecond end portion 1142 so that the circular boss extends upwardly beyond an upper surface of the second end portion. Thedriver 1130 is then placed in thefirst recess 1044 of thebase plate portion 1014 of thehousing 1012 so that thecentral opening 1148 of theyoke portion 1132 of the driver receives the protrudingportion 1056 of the base plate portion that includes theelliptical aperture 1038. When thedriver 1130 is placed in thefirst recess 1044, thebases 1322 of theblind nuts 1316 and the rectangular protrusions of theblade support portion 1238, thefirst end portion 1140, and thesecond end portion 1142 are received in the second recess 1080 of thebase plate portion 1014. The second recess 1080 acts to guide thedriver 1130 during movement relative to thebase plate portion 1014. - When the
driver 1130 is located in thebase plate portion 1014 of thehousing 1012, the proximal and distal engagingmembers slots base plate portion 1014 and slightly into thecavity 1034 of the base plate portion. Thedriver 1130 is positioned within thefirst recess 1044 so that the first and secondcollapsible legs portion 1134 of thedriver 1130 engage the first andsecond side surfaces first recess 1044, as is shown inFIG. 45 . - The
blade 1290 is then placed over theblade support portion 1238 of the cuttingportion 1134 of thedriver 1130 so that thecircular boss 1320 of theblind nut 1316 that extends through theaperture 1260 in the blade support portion also extends through theaperture 1296 of the blade. Theblade 1290 is also received in thefirst recess 1044 of thebase plate portion 1014. The first andsecond side surfaces first recess 1044 prevent theblade 1290 from rotating about thecircular boss 1320 and relative to thebase plate portion 1014. - The
top plate portion 1016 of thehousing 1012 is placed over thebase plate portion 1014 of the housing. Theslot 1120 of thetop plate portion 1016 receives thecircular boss 1320 of theblind nut 1316 that extends through theaperture 1296 of theblade 1290. Theslot 1122 receives thecircular boss 1320 of theblind nut 1316 that extends through thesecond end portion 1142 of theyoke portion 1132 of thedriver 1130. When thetop plate portion 1016 is properly positioned relative to thebase plate portion 1014, the fastener holes 1118 and theelliptical aperture 1116 of thelop plate portion 1016 are in locations corresponding to the fastener holes 1082 and theelliptical aperture 1038 of thebase plate portion 1014. - Four
fasteners 1314 are then inserted through the fastener holes 1118 of thetop plate portion 1016 and the fastener holes 1082 of thebase plate portion 1014 to hold the top plate portion relative to the base plate portion. Theaperture 1308 in theactuator handle 1304 is aligned with and receives thecircular boss 1320 of theblind nut 1316 that extends through theaperture 1296 of theblade 1290. Afastener 1314 fixes theactuator handle 1304 to theblind nut 1316. Theaperture 1310 in theactuator handle 1306 is aligned with and receives thecircular boss 1320 of theblind nut 1316 that extends through theaperture 1202 in thesecond end portion 1142. Afastener 1314 fixes theactuator handle 1306 to theblind nut 1316. - After assembly of the
device 1010 is complete, thedevice 1010 is turned over so that aclip 1326 may be attached to the device. Exemplary clips are illustrated inFIGS. 49-63 and are discussed later in this application. Theclip 1326 ofFIG. 43 includes opposite first andsecond retaining portions 1228 and 1230, respectively, that when pressed together clamp onto tissue. - To attach the
clip 1326 to thedevice 1010, theclip 1326 is placed in thecavity 1034 that extends into thelower surface 1020 of thebase plate portion 1014. Thefirst retaining portion 1328 of theclip 1326 is supported on the recessed end of the proximal engagingmember 1208 and thesecond retaining portion 1330 is supported on the recessed end of the distal engagingmember 1210. - To use the
device 1010 for removing a lesion or other portion of tissue, thelower surface 1020 of thebase plate portion 1014 of the assembleddevice 1010, to which theclip 1326 has been attached, is placed against a patient's tissue. A skin hook, or another device for grabbing the patient's tissue, is inserted through theelliptical apertures housing 1012 and grabs the tissue. The skin hook pulls the tissue through theclip 1326 and theelliptical apertures housing 1012. When pulled through theelliptical apertures - The first and second actuator handles 1304 and 1306 are pushed together to actuate the
driver 1130. When the first and second actuator handles 1304 and 1306 are moved toward one another, the side surfaces 1058 and 1060 of the first portion 1048 of thefirst recess 1044 prevent the first and secondcollapsible legs portion 1134 of thedriver 1130 from collapsing, as illustrated inFIG. 45 . As a result, the proximal and distal engagingmembers clip 1326. When theclip 1326 begins to close, tines of theclip 1326 pierce the tensioned tissue and the clip begins to pinch the tissue.FIG. 46 illustrates thedevice 1010 with theclip 1326 partially closed. - Adjusting the location of the
corners blade 1290 and clamping the tissue with theclip 1326 to be controlled. The longitudinal lengths ofside surfaces FIG. 45 as distance Y, controls the timing of when the first and secondcollapsible legs portion 1134 of thedriver 1130 begin to collapse. Thus, by adjusting the distance Y, thedevice 1010 timing for cutting the tissue with theblade 1290 and clamping the tissue with theclip 1326 may be adjusted. For example, when the distance Y is increased, theyoke portion 1132 of thedriver 1130 will close theclip 1326 prior to the cuttingportion 1134 moving theblade 1290 to cut the tissue. - When the living hinges of the first and second
collapsible legs portion 1134 of thedriver 1130 extend longitudinally beyond thecorners FIG. 46 , thecollapsible legs actuator handle 1304 continues to move toward throughslot 1120 toward theelliptical aperture 1116, thecollapsible legs portion 1134 of thedriver 1130 collapse into the position illustrated inFIG. 47 and theblade support portion 1238 moves into contact with thefirst end portion 1140 of theyoke portion 1132 of thedriver 1130. During the movement of theblade support portion 1238 toward thefirst end portion 1140, theblade 1290 cuts the tissue that extends through theelliptical aperture 1116 of thetop plate portion 1016 of thehousing 1012. - The tissue that extends through the
elliptical aperture 1038 of thebase plate portion 1014 of thehousing 1012 remains pinched between the first andsecond retaining portions clip 1326. After theblade support portion 1238 of the cuttingportion 1134 of thedriver 1130 contacts thefirst end portion 1140 of theyoke portion 1132 of the driver, further movement of the actuator handles 1304 and 1306 toward one another and toward theelliptical aperture 1116 moves the proximal engagingmember 1208 and the distal engagingmember 1210, respectively, toward a center of theelliptical aperture 1116. The proximal and distal engagingmembers second retaining portions clip 1326 together. When the first and second actuator handles 1304 and 1306 reach the ends of theslots second retaining portions clip 1326 fully occlude the wound that results from excision of the tissue.FIG. 48 illustrates thedriver 1130 and theclip 1326 when the clip is in a closed condition. - After the
clip 1326 fully occludes the wound, the actuator handles 1304 and 1306 are moved away from one another to cause the proximal and distal engagingmembers clip 1326. As an alternative to manually moving the actuator handles 1304 and 1306 away from one another, thedevice 1010 may be modified to include a biasing member or spring that biases thefirst end portion 1140 of theyoke portion 1132 of thedriver 1130 in a direction for releasing theclip 1326. For example, the biasing member may form an integral part of thedriver 1130. - Preferably, all of the parts of the
device 1010, with the exception of theblade 1290 and theclip 1326, are molded from plastic. In a preferred embodiment, thedevice 1010 is a single use device that is discarded after its use while theclip 1326 remains attached to the skin to close the wound. Thedevice 1010 may come in various sizes for removing lesions of various sizes. When multiple sizes of thedevice 1010 are available, a template may be supplied for enabling the clinician to determine the correct size of thedevice 1010 to be used in removing the desired lesion. -
FIG. 49 is a first exemplary embodiment of a closure member orclip 1502. The clip 1052 ofFIG. 49 may be used with thedevices FIGS. 35 and 42 . Theclip 1502 is preferably stamped from stainless steel, titanium, or any other bio-compatible metal. - The
clip 1502 includes aplanar body portion 1504. Thebody portion 1504 of theclip 1502 includes first andsecond retaining portions 1506 and 1508, respectively, and first and seconddeformable portions second ends second retaining portion 1508 includes opposite first andsecond ends - The first
deformable portion 1512 connects thefirst end 1516 of the first retaining portion 1506 and thefirst end 1522 of thesecond retaining portion 1508. The firstdeformable portion 1512 includes threedeformation zones 1528. Each of thedeformation zones 1528 is formed from a thinned portion of the firstdeformable portion 1512. Eachdeformation zone 1528 has a width, measured within the plane of thebody portion 1504 of theclip 1502, i.e., within the plane ofFIG. 49 , that is less than a material thickness of the firstdeformable portion 1512, measured in a direction perpendicular to the plane of the body portion of the clip, i.e., intoFIG. 49 . - The
second deformable portion 1514 connects thesecond end 1518 of the first retaining portion 1506 and thesecond end 1524 of thesecond retaining portion 1508. Thesecond deformable portion 1512 also includes threedeformation zones 1530. Each of thedeformation zones 1530 of thesecond deformable portion 1514 has a width, measured within the plane of thebody portion 1504 of theclip 1502, that is less than a material thickness of thesecond deformable portion 1514, measured in a direction perpendicular to the plane of the body portion of the clip. - An oblong or
elliptical opening 1532 is formed between the first andsecond retaining portions 1506 and 1508 and the first and seconddeformable portions tines 1534 extends outwardly of the first retaining member 1506 and into theopening 1532. A second set oftines 1536 extends outwardly of thesecond retaining member 1508 and into theopening 1532. The first and second sets oftines FIG. 49 . - The
clip 1502 has an open condition shown inFIG. 49 and a closed condition.FIGS. 41 and 48 illustrateclips clip 1502 in closed conditions. When in the open condition, theopening 1532 of theclip 1502 is adapted to receive tissue. In the closed condition, the first andsecond retaining portions 1506 and 1508 of theclip 1502 move together to clamp the tissue and occlude a wound. When theclip 1502 is in the closed condition, the first and second sets oftines opening 1532 for retaining the clip to the tissue. - The
body portion 1504 of theclip 1502 may be planar in both the open condition and the closed condition. Thebody portion 1504 may also be planar during movement between the open and closed conditions. It should be understood by those of ordinary skill in the art that the configuration of theclip 1502 may be changed to be non-planar, such as by placing tines of theclip 1502 out of a plane of thebody portion 1504.FIGS. 39 and 40 illustrate aclip 870 that is similar toclip 1502 during movement between the open and closed conditions. Similarly,FIGS. 46 and 47 illustrate aclip 1326 that is similar toclip 1502 during movement between the open and closed conditions. During movement between the open and closed conditions, thedeformation zones deformable portions clip 1502 are deformed to enable movement within the plane of thebody portion 1504. -
FIG. 50 illustrates a second exemplary embodiment of aclip 1502 a. Theclip 1502 a ofFIG. 50 is similar to theclip 1502 ofFIG. 49 and therefore, structures ofFIG. 50 that are the same as or similar to those described with reference toFIG. 49 have the same reference numbers with the addition of the suffix “a”. - The
clip 1502 a ofFIG. 50 is identical to theclip 1502 ofFIG. 49 with the exception of the first and second sets of tines 1534 a and 1536 a. InFIG. 50 , the first and second sets of tines 1534 a and 1536 a include fewer tines that the first and second sets oftines FIG. 49 . Also, inFIG. 50 , each tine of the first and second sets of tines 1534 a and 1536 a includes a taperedsurface 1544. The taperedsurface 1544 sharpens the point 1540 a of each of the tines of the first and second sets of tines 1534 a and 1536 a. -
FIG. 51 illustrates a third exemplary embodiment of a clip 1502 b. The clip 1502 b ofFIG. 51 is similar to theclip 1502 ofFIG. 49 and therefore, structures ofFIG. 51 that are the same as or similar to those described with reference toFIG. 49 have the same reference numbers with the addition of the suffix “b”. - The clip 1502 b of
FIG. 51 is identical to theclip 1502 ofFIG. 49 with the exception of the first and second sets oftines 1534 b and 1536 b and the inclusion of lockingdevices 1548. InFIG. 51 , the first and second sets oftines 1534 b and 1536 b include fewer tines that the first and second sets oftines FIG. 49 . Also, inFIG. 51 , the clip 1502 b includes thelocking devices 1548 for locking the clip in the closed condition. - One
locking device 1548 is associated with each of the first and seconddeformable portions 1512 b and 1514 b. Eachlocking device 1548 includes first and secondtoothed members toothed members locking devices 1548 mesh together to lock the clip in the closed condition. -
FIG. 52 illustrates a fourth exemplary embodiment of theclip 1602. Theclip 1602 includes a planar body portion 1604 having first and second retaining portions 1606 and 1608, respectively, and first and seconddeformable portions 1612 and 1614, respectively. The first andsecond retaining portions 1612 and 1614 include docking features 1622 for enabling the first and second retaining portions to be docked onto a closing device. - An
opening 1624 in theclip 1602 is formed from the first and second retaining portions 1606 and 1608 and the first and seconddeformable portions 1612 and 1614.FIG. 52 illustrates theclip 1602 having asingle tine 1626 that extends inwardly into theopening 1624 from thefirst retaining portion 1612 and asingle tine 1628 that extends inwardly into theopening 1624 from the second retaining portion 1614. Prior to use, thetines - The first
deformable portion 1612 of theclip 1602 includes a single outwardly extendingtine 1634 and fourdeformation zones 1636, only two of which are labeled inFIG. 52 . Likewise, the second deformable portion 1614 of theclip 1602 includes a single outwardly extending tine 1638 and four deformation zones 1640, only two of which are labeled inFIG. 52 . Each of thedeformation zones 1636 and 1640 of theclip 1602 has a width, measured within the plane of the body portion 1604, that is less than a material thickness of the body portion, measured in a direction perpendicular to the plane of the body portion of the clip so as to enable the clip to remain planar during movement from an open condition to a closed condition. -
FIG. 53 illustrates a fifth exemplary embodiment of a clip 1602 a. The clip 1602 a ofFIG. 53 is similar to theclip 1602 ofFIG. 51 and therefore, structures ofFIG. 53 that are the same as or similar to those described with reference toFIG. 52 have the same reference numbers with the addition of the suffix “a”. - The clip 1602 a of
FIG. 53 is identical to theclip 1602 ofFIG. 52 with the exception of the number of inwardly extending tines.FIG. 53 illustrates the clip 1602 a having two tines 1626 a that extend inwardly into the opening 1624 a from the first retaining portion 1606 a and three tines 1628 a that extends inwardly into the opening from the second retaining portion 1608 a. Prior to use, the tines 1626 a and 1628 a are bent to extend at an angle of in the range of approximately twenty to ninety degrees relative to the planar body portion 1604 a. -
FIG. 54 illustrates a sixth embodiment of the clip 1702. The clip 1702 includes aplanar body portion 1704 that includes first andsecond retaining portions 1706 and 1708, respectively, and first and second deformable portions 1712 and 1714, respectively. - The first and second deformable portions 1712 and 1714 of the clip 1702 include
deformation zones 1720. The first andsecond retaining portions 1706 and 1708 includeexpansion zones 1722. Thedeformation zones 1720 and theexpansion zones 1722 enable thebody portion 1704 of the clip 1702 to remain planar during movement from an open condition to a closed condition. - An
opening 1726 in the clip 1702 is located between the first andsecond retaining portions 1706 and 1708 and the first and second deformable portions 1712 and 1714. Thefirst retaining portion 1706 of the clip 1702 includes a first set oftines 1728 that extends inwardly into theopening 1726 and a second set oftines 1730 that extends outwardly away from the opening. Likewise, the second retaining portion 1708 of the clip 1702 includes a first set oftines 1734 that extends inwardly into theopening 1726 and a second set of tines 1736 that extends outwardly away from the opening. All of thetines opening 1726. Prior to use, thetines planar body portion 1704. -
FIG. 55 illustrates a seventh exemplary embodiment of a clip 1702 a. The clip 1702 a ofFIG. 55 is similar to the clip 1702 ofFIG. 54 and therefore, structures ofFIG. 55 that are the same as or similar to those described with reference toFIG. 54 have the same reference numbers with the addition of the suffix “a”. - The clip 1702 a of
FIG. 55 is identical to the clip 1702 ofFIG. 54 with the exception that, the tines 1728 a, 1730 a, 1734 a, and 1736 a of the clip 1702 a extend parallel to one another and not radially relative to a center of the opening 1726 a. Again, prior to use, the tines 1728 a, 1730 a, 1734 a, and 1736 a are bent to extend at an angle of in the range of approximately twenty to ninety degrees relative to the planar body portion 1704 a. - The
clip 1802 ofFIG. 56 includestines 1804 that have planar ends 1808. Theclip 1812 ofFIG. 57 has a bone-shape with lobeddeformable portions clip 1822 ofFIG. 58 is oval. Each of thedeformable portions 1824 and 1826 of theclip 1822 ofFIG. 58 includes only asingle deformation zone 1828. Theclip 1832 ofFIG. 59 is oblong and, similar to theclip 1822 ofFIG. 58 , includes only asingle deformation zone 1834 in each deformable portion 1836 and 1838. Prior to use, the tines of theclips FIGS. 56-59 , respectively, are bent to extend at an angle of in the range of approximately twenty to ninety degrees relative to the planar body portion. - The
clip 1902 ofFIG. 60 includes a planar body portion 1904 having first andsecond retaining portions deformable portions 1910 and 1912, respectively. A first set oftines 1914 extends outwardly from thefirst retaining portion 1906. A second set oftines 1916 extends outwardly from thesecond retaining portion 1908. A single 1920 tine extends outwardly of each of thedeformable portions 1910 and 1912. Prior to use of theclip 1902, thetines clip 1902. Prior to use, thetines - The
clip 2002 ofFIG. 61 includes aplanar body portion 2004 having first andsecond retaining portions deformable portions second retaining portions first retaining portion 2006. A second set oftines 2022 extends outwardly from and perpendicular to thesecond retaining portion 2008. -
FIG. 62 illustrates a clip 2102 that includes a planar body portion 2104 having first andsecond retaining portions deformable portions second retaining portions tines 2120 extends outwardly from and perpendicular to thefirst retaining portion 2106. A second set oftines 2122 extends outwardly from and perpendicular to thesecond retaining portion 2108. - The clip 2102 of
FIG. 62 also includes twolocking devices 2126. Eachlocking device 2126 includes abarb 2128 and an associated receivingportion 2130. When the clip 2102 is moved to the closed condition, thebarb 2128 of eachlocking device 2126 pierces its associated receivingportion 2130 and locks in the associated receiving portion. -
FIG. 63 illustrates a fifteenth exemplary embodiment of a clip 1502 c. The clip 1502 c ofFIG. 63 is similar to theclip 1502 ofFIG. 49 and therefore, structures ofFIG. 63 that are the same as or similar to those described with reference toFIG. 49 have the same reference numbers with the addition of the suffix “c”. - The first and second
deformable portions 1512 c and 1514 c, respectively, of thebody portion 1504 c of the clip 1502 c ofFIG. 63 are formed from a polymeric material that degrades after a predetermined time period for releasing the clip 1502 c from the tissue. In a preferred embodiment of the invention, the first and seconddeformable portions 1512 c and 1514 c are formed from an acetyl with a high starch concentration, preferably 10 to 20 percent. The starch absorbs moisture and degrades so that the clip 1502 c is released. Preferably, the clip 1502 c is released in a period of approximately one to two weeks. - While the present invention has been described as having exemplary structures and methods, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.
Claims (44)
1. A device for excising tissue and closing a wound that results from excision of the tissue, the device comprising:
structure defining an aperture for completely framing tissue to be excised;
a cutting member for excising the tissue;
a closure member for closing the wound; and
an actuatable drive member associated with the structure, the drive member being actuatable to move the cutting member relative to the aperture for excising the tissue that is framed by the aperture and for closing the wound with the closure member.
2. The device of claim 1 wherein the drive member moves the cutting member relative to the structure defining the aperture and closes the wound with the closure member at a location adjacent the structure defining the aperture.
3. The device of claim 1 wherein the drive member includes first and second portions, the first portion of the drive member supporting the cutting member and the second portion of the drive member moving the closure member from an open condition to a closed condition, the closure member, when in the closed condition, closing the wound.
4-8. (canceled)
9. The device of claim 3 wherein the first portion of the drive member moves the cutting member relative to the structure defining the aperture so that the structure guards against cutting any tissue other than the tissue that is framed by the aperture.
10-11. (canceled)
12. The device of claim 1 wherein the drive member moves the cutting member relative to the structure defining the aperture so that only the tissue that is framed by the aperture is cut.
13. The device of claim 1 wherein the drive member includes first and second portions, the first portion of the drive member supporting the cutting member and the second portion of the drive member moving the closure member from an open condition to a closed condition in which the closure member closes the wound, the second portion of the drive member surrounding the structure defining the aperture.
14. (canceled)
15. The device of claim 1 wherein the drive member supports the cutting member, the drive member beginning to move the closure member toward the closed condition prior to excising the tissue that is framed by the aperture with the cutting member.
16. The device of claim 1 wherein a single actuator handle is attached to the drive member, the drive member being actuated in response to movement of the single actuator handle relative to the structure defining the aperture.
17. The device of claim 1 wherein first and second actuator handles are attached to opposite ends of the drive member, the drive member being actuated in response to movement of the first and second actuator handles toward one another.
18. The device of claim 1 wherein the closure member includes a planar body portion, the body portion including first and second retaining portions and a deformable portion that connects the first and second retaining portions, the closure member having an open condition in which the deformable portion spaces the first and second retaining portions apart from one another and a closed condition in which the deformable portion is elastically deformed to bring the first and second retaining portions together to close the wound, the body portion of the closure member being planar in both the open and closed conditions.
19. The device of claim 18 wherein the closure member further includes first and second sets of tines, the first set of tines extending outwardly of the first retaining portion and the second set of tines extending outwardly of the second retaining portion, at least one of the first and second sets of tines including skin-piercing portions that, when the closure member is in the closed condition, engage tissue adjacent the wound to secure the body portion of the closure member relative to the tissue.
20. The device of claim 19 wherein the first and second sets of tines are located within a plane of the body portion of the closure member.
21. A method for excising tissue and closing a wound that results from excision of the tissue, the method comprising the steps of:
framing the tissue to be excised with an aperture formed in a structure;
moving a portion of a drive member over a first distance to move a closure member into engagement with the tissue that is framed by the aperture;
moving the drive member over a second distance beyond the first distance so as to move a cutting member relative to the aperture for excising the tissue that is framed by the aperture; and
moving the drive member over a third distance beyond the second distance after the tissue is at least partially excised, for closing the wound with the closure member.
22. The method of claim 21 wherein the steps of moving the drive member each include the steps of:
engaging a single actuator handle associated with the drive member; and
moving the single actuator handle relative to the structure.
23. The method of claim 21 wherein the steps of moving the drive member each include the steps of:
engaging a first actuator handle associated with a portion of the drive member located on a first side of the aperture;
engaging a second actuator handle associated with a portion of the drive member located on a second side of the aperture; and
moving the first and second actuator handles together.
24. A method for excising tissue and closing a wound that results from excision of the tissue, the method comprising the steps of:
completely framing the tissue to be excised with an aperture formed in a structure;
moving a portion of a drive member over a first distance to move a closure member into a closed condition for clamping the tissue that is framed by the aperture;
moving the drive member over a second distance beyond the first distance so as to move a cutting member relative to the aperture for excising the tissue that is framed by the aperture.
25. The method of claim 24 wherein the steps of moving the drive member each include the steps of:
engaging a single actuator handle associated with the drive member; and
moving the single actuator handle relative to the structure.
26. The method of claim 24 wherein the steps of moving the drive member each include the steps of:
engaging a first actuator handle associated with a portion of the drive member located on a first side of the aperture;
engaging a second actuator handle associated with a portion of the drive member located on a second side of the aperture; and
moving the first and second actuator handles together.
27. An exciser for excising tissue, the exciser comprising:
structure defining an aperture into which tissue to be excised is exposed;
a cutting member for excising the tissue;
an actuatable drive member associated with the structure, the drive member being actuatable to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture; and
an actuator handle associated with the drive member, movement of the actuator handle relative to the structure actuating the drive member.
28. The exciser of claim 27 wherein the drive member moves the cutting member relative to the structure defining the aperture so that only the tissue that is exposed in the aperture is cut.
29. The exciser of claim 27 wherein the drive member includes a support portion for supporting the cutting member, the actuator handle being fixedly attached to the support portion so that the cutting member is interposed between the support portion and the actuator handle.
30. The exciser of claim 29 wherein the drive member further includes an end wall that is spaced from the support portion and a pair of collapsible legs that connect the support portion and the end wall, the cutting member, when attached to the support portion extending outwardly of the support portion and toward the end wall, movement of the actuator handle causing the pair of collapsible legs to collapse and moving the support portion toward the endwall, the cutting member excising the tissue that is exposed in the aperture during movement of the support portion toward the end wall.
31. The exciser of claim 30 further including a top plate that overlies the base plate to form a housing, the drive member being located in the recess of the base plate and between the base plate and the top plate, the actuator handle being located on a side of the top plate opposite the base plate, the top plate including an elongated slot through which the actuator handle is attached to the drive member, movement of the actuator handle through the slot of the top plate actuating the drive member.
32. The exciser of claim 31 wherein the cutting member is also located between the base plate and the top plate, the cutting member engaging only the tissue that is exposed in the aperture of the structure.
33. The exciser of claim 27 wherein the actuator handle is a first actuator handle and wherein the exciser further includes a second actuator handle, the second actuator handle being located on a side of the aperture opposite the first actuator handle, the drive member being actuated in response to movement of the first and second actuator handles toward one another.
34. A method of excising tissue, the method comprising the steps of:
exposing tissue into an aperture defined in a structure;
supporting a cutting member on an actuatable drive member that is movable relative to the structure;
associating an actuator handle to the drive member; and
moving the actuator handle to actuate the drive member to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture.
35. A closure member for clamping tissue adjacent a wound, the closure member comprising:
a planar body portion including first and second retaining portions and a deformable portion that connects the first and second retaining portions, the closure member having an open condition in which the deformable portion spaces the first and second retaining portions apart from one another so that the tissue to be clamped may be placed between the first and second retaining portions, the closure member also having a closed condition in which the deformable portion is elastically deformed to bring the first and second retaining portions together to clamp the tissue between the first and second retaining portions, the body portion of the closure member being planar in both the open and closed conditions, the closure member further including a first set of tines that extends outwardly of the first retaining portion and a second set of tines that extends outwardly of the second retaining portion, the first and second sets of tines engaging the tissue to secure the body portion to the tissue when the closure member is in the closed condition.
36. The closure member of claim 35 wherein the first set of tines includes multiple tissue engaging members and wherein the second set of tines also includes multiple tissue engaging members.
37. The closure member of claim 35 wherein the first and second sets of tines are located within a plane of the body portion.
38. The closure member of claim 35 wherein the first and second sets of tines are positioned relative to one so as to mesh together when the closure member is in the closed condition.
39. The closure member of claim 35 wherein the deformable portion includes multiple deformation zones, a width, measured in the plane of the body portion, of the material within the deformation zones being less than a material thickness of the body portion, measured in a direction perpendicular to the plane of the body portion.
40. The closure member of claim 35 further including structure for locking the closure member in the closed condition.
41. The closure member of claim 40 wherein the structure for locking the closure member in the closed condition includes first and second toothed members, the first and second toothed members meshing together when the closure member is in the closed condition.
42. The closure member of claim 35 wherein the deformable portion is a first deformable portion and the closure member also includes a second deformable portion, the first deformable portion connecting a first end of the first retaining portion to a first end of the second retaining portion, the second deformable portion connecting a second end of the first retaining portion to a second end of the second retaining portion.
43. The closure member of claim 42 wherein an oblong opening is defined in the closure member when the closure member is in the open condition, the oblong opening being adapted for accepting tissue and having a length that is defined between the first and second deformable portions and a width that is defined between the first and second retaining portions, the length of the oblong opening being greater than the width of the oblong opening.
44. The closure member of claim 35 wherein the closure member is formed from a polymeric material that degrades after a predetermined time period for releasing the closure member from the tissue.
45. The closure member of claim 35 wherein the body portion remains planar during movement between the open and closed conditions.
46. The method of claim 21 wherein the closure member further includes at least one skin-piercing portion adapted to engage tissue adjacent the wound to secure the closure member relative to the tissue when the closure member is closing the wound.
47. A device for excising tissue and closing a wound that results from excision of the tissue, the device comprising:
structure defining a completely framing aperture into which tissue to be excised is exposed, the aperture being in contact with the tissue to limit at least one of a size and a shape of the tissue;
a cutting member for excising the tissue;
a closure member for closing the wound; and
an actuatable drive member associated with the structure, the drive member being actuatable to move the cutting member relative to the aperture for excising the tissue that is exposed in the aperture and for closing the wound with the closure member.
48. The device of claim 47 , including a housing member within which the closure member is at least partially located and wherein the structure defining an aperture is associated with at least one of the closure member and the housing.
49. The device of claim 47 , wherein the tissue is pulled through the aperture and the aperture limits at least one of a size and a shape of the tissue at least partially by resisting tension resulting from the pulling of the tissue through the aperture.
Priority Applications (1)
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US12/062,085 US20080249549A1 (en) | 2001-10-01 | 2008-04-03 | Skin lesion exciser and skin-closure device therefor |
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US35752002P | 2002-02-15 | 2002-02-15 | |
US10/261,155 US7806907B2 (en) | 2001-10-01 | 2002-09-30 | Skin lesion exciser and skin-closure device therefor |
US10/845,313 US7513902B2 (en) | 2001-10-01 | 2004-05-13 | Skin lesion exciser and skin-closure device therefor |
US12/062,085 US20080249549A1 (en) | 2001-10-01 | 2008-04-03 | Skin lesion exciser and skin-closure device therefor |
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US10/845,313 Continuation US7513902B2 (en) | 2001-10-01 | 2004-05-13 | Skin lesion exciser and skin-closure device therefor |
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US12/062,085 Abandoned US20080249549A1 (en) | 2001-10-01 | 2008-04-03 | Skin lesion exciser and skin-closure device therefor |
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US10/845,313 Expired - Fee Related US7513902B2 (en) | 2001-10-01 | 2004-05-13 | Skin lesion exciser and skin-closure device therefor |
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WO2011066533A1 (en) * | 2009-11-30 | 2011-06-03 | Clevex, Inc. | Clip assembly and method for approximating a wound in tissue |
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EP1962703A2 (en) * | 2005-12-21 | 2008-09-03 | The Cleveland Clinic Foundation | Apparatus and method for excising tissue and bandaging the resulting wound |
US20070232954A1 (en) * | 2006-04-04 | 2007-10-04 | Harris Jeffrey P | Automated skin biopsy device |
US7696399B2 (en) * | 2006-08-23 | 2010-04-13 | Rogers Gary S | Sutureless wound closure and method of application |
US20090253998A1 (en) * | 2008-04-03 | 2009-10-08 | Convergent Medical Solutions, Inc. | Skin biopsy with suturing prior to resection |
US20090253997A1 (en) * | 2008-04-03 | 2009-10-08 | Convergent Medical Solutions, Inc. | Skin biopsy with automated lesion stabilization and resection |
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DE602005017136D1 (en) | 2009-11-26 |
US7513902B2 (en) | 2009-04-07 |
CA2566066A1 (en) | 2005-12-01 |
EP1744680B1 (en) | 2009-10-14 |
AU2005244855B2 (en) | 2010-01-21 |
JP2007537008A (en) | 2007-12-20 |
CN1980607A (en) | 2007-06-13 |
WO2005112790A1 (en) | 2005-12-01 |
EP1744680A1 (en) | 2007-01-24 |
ATE445365T1 (en) | 2009-10-15 |
US20040215217A1 (en) | 2004-10-28 |
CA2566066C (en) | 2010-11-30 |
AU2005244855A1 (en) | 2005-12-01 |
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