CA2197066A1 - Wound closure device - Google Patents
Wound closure deviceInfo
- Publication number
- CA2197066A1 CA2197066A1 CA002197066A CA2197066A CA2197066A1 CA 2197066 A1 CA2197066 A1 CA 2197066A1 CA 002197066 A CA002197066 A CA 002197066A CA 2197066 A CA2197066 A CA 2197066A CA 2197066 A1 CA2197066 A1 CA 2197066A1
- Authority
- CA
- Canada
- Prior art keywords
- needle
- sheath
- surgical device
- distal end
- actuator
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06066—Needles, e.g. needle tip configurations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B17/2909—Handles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
- A61B2017/047—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
- A61B2017/0472—Multiple-needled, e.g. double-needled, instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06004—Means for attaching suture to needle
- A61B2017/06019—Means for attaching suture to needle by means of a suture-receiving lateral eyelet machined in the needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06004—Means for attaching suture to needle
- A61B2017/06042—Means for attaching suture to needle located close to needle tip
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06066—Needles, e.g. needle tip configurations
- A61B2017/06085—Needles, e.g. needle tip configurations having a blunt tip
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0801—Prevention of accidental cutting or pricking
- A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30092—Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
- A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
Abstract
A surgical device (2) for closing trocar incision sites and delivering sutures (36). The present invention is a needle assembly (2) in which the needle (4) assembly is constructed of a spring-like material and initially housed within a sheath (6) in a deformed condition. The needle (4) can be easily exposed by sliding an actuator (8) so as to release the constraining means (32) and allow the needle (4) to assume its undeformed condition. The needle assembly (2) has few parts, allows a wide range for deflection of the needle (4), and the needle (4) may be exposed with a relatively short stroke.
Description
2 1 q~O66 WOUND CI OSURF. DF.VICF
This invention relates to a surgical instrument for closing the edges of a woundtogether with surgical sutures.
Rackrol-nd of the Inve~tion Minimurn invasive surgery generally includes the creation of trocar puncture wounds through the abdominal wall of a patient for insertion of a variety of surgical ins~ment~
The structural strength of the abdominal wall is derived mostly from one or more layers of fascia disposed beneath the s~in and between layers of muscle. Unless closed p,o~.ly, the abdominal contents may h~rni~te through these wounds, or body fluids can accumulate, promoting infection. Presently, ~ulgeons attempt to close trocar puncture wounds using conventional needle drivers which are often cumbersome, rnaking it difficult to plo~.ly close the wound.
Larger trocars (lOrnm and larger) are commonly used for surgical procedures. Forlarge trocars and to avoid potential h~rni~c, it is desirable to uhlize flexible threads, or sutures, passing through apposing tissue edges tied to hold the more deeply buried portions of the edge of the wound together. Attempts have been made to address these problems. for example, in U.S. Patent Nos. 5,368,601 to Sauer et al; 5,374,275 to Bradley et al; and European Patent Application No. 0 634 141. However, these devices employ multiple needles, which result in a complex device which is complicated in use and expensivc ~o m~nllf~ctl-re.
U.S. Patent No. 5,403,328 to Sh~llm~n describes a surgical a~dl~lus for closing a ~trocar incision. The Sh~llm~n device includes a curved needle pivotally positioned ~ithin a casing. The meçh~ni~m for pivoting the needle of Sh~llm~n is somewhat cumbersomc. c~cn while deflection of the needle is limited, and requires a long stroke to manipulate the nee~lc Snrnm~ly of th~ ~nv.ontiorl I have ~lesign~d a simple instrument for closing trocar incision sites and delivering sutures. The present invention is a needle assembly in which the needle is constructed of a spring-like material and initially housed within a sheath in a deformed condition. The needle can be easily exposed by sliding an actuator so as to release cor~ g means and allow the needle to assume its undeformed condition. The needle asselllbly has few parts, allows a wide range for deflection of the needle, and the needle may be exposed with a relatively short stroke.
A first aspect of the invention co...l,. ;cçs a surgical device for ~ g a wound in the tissue of a patient comrri~ing:
a sheath having a longitudinal axis in~ Air~ a p~v~illlal end and a distal end;
a recess formed in the wall of said sheath toward said distal end;
a needle constructed of a spring-like m~t,çri~l, said needle being movable from a first retracted position wherein said needle is withdrawn into said recess to a second exposed position wherein said needle is extended from said recess;
means for constraining said needle in its retracted position by defc.ll~g said needle;
an actuator at said proximal end of said sheath for r~leasi~g said COlisll~illillg means, so as to thereby allow said needle to assume its undefollllcd condition and move to said exposed position;
said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said pro~ al end.
A further aspect of the invention comprises a surgical device for s~ ring a wound in the tissue of a patient comprising:
a sheath having a longitudinal axis including a p~ hllal end and a distal end;
a recess formed in the wall of said sheath toward said distal end;
a needle constructed of a shape memory alloy m~t~.ri~l CO~ g a generally S-shape and including a body and having one end fixedly ~ ch~d to the interior of the distal end of said sheath, the body of said needle being movable in said sheath from a first position wherein said needle is retracted into said recess to a second position t;A~osed wherein said needle is ex~n~d laterally from said recess;
means for cor~ll~ ing said needle in its retracted;
an actuator at said proximal end of said sheath for rele~cin~ said cG~ -g means, said a ;~ lor comprising:
a sleeve slidable within said sheath;
an opening formed in the distal end of said sleeve through which said needle extends in the exposed position;
wherein said means for co~l~ g cu...l..;~s a section of said sleeve formed ~1~ ~ ~ n said opening and the distal end of said ~ or such that upon release of said means for co~ i,ling said needle moves to said second, exposed position;
said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said pro~ al end.
Brief T )escription of th-o ~rawin~(s) Fig. 1 is a ~l~cctive view of the present invention.
Fig. 2 is an exploded view of device of Fig. 1.
Figs. 3a, 3b and 3c are scll~om~tic views of deployment of the present invention.
Figs. 4a, 4b and 4c are s~hem~tic views of a second embodiment of the present invention.
Description of the P~eff .ed Fmho-limf~nt~
Referring now to the drawings, Fig. 1 illustrates a surgical device in the form of a puncture closure device 2 including a needle 4 movable in sheath 6. An actuator 8 is capable of moving needle 4 from a first, retracted position, as seen in Fig. 3a, to a second, eYrose~1 position, as seen in Figs. 1 and 3c. Device 2 is dçci~ed to be used in a sterile surgical field. The device may be disposable or reusable or partially ~licpos~ble or reusable.
The outer radial-lim~n~ion of device 2 is lOmm or less.
Sheath 6 is a tubular sheath having a proximal end 10 and a distal end 12 disposed along opposite ends of longit~ inAI axis 14. Sheath 6 in~ dçc a blunt tip 16 located at the distal end and a gripping section 18 located at the l)roxilllal end. The allv~ge of a blunt end is to eliminAte risk of inadvertent puncture of organs or tissue when inserting the device into a wound. A recess 20 is formed in the wall of the sheath ~ljflc~nt to blunt tip 16 through which needle 4 may be ~tçrl~ed as seen in the Figures and as rliecllcc-ed below.
Needle 4 includes a body having a generally S-shaped configuration. A first end 22 of needle 4 is fixedly ~tt~ched to the interior of the distal end of the sheath. Needle 4 may be fixedly AttAc~d to sheath 6 at end 22 by pins or other ~ fltt~l....~..l, or may be formed with the sheath. The end opposite first end 22 of needle 4 is rnanipulation end 24, which includes a straightened portion 26. It should be noted, however, that the manipulation end may include a curved portion, rather than strAighhon~l portion 26. Needle 4 is constructed of a spring-like mAt~riAl In its llnr~efo.. l~A configuration, needle 4 A~.. ÇS
its S-shaped configuration exposed so that the S-shape extends f~om fixed end 22 through recess 20 to manipulation end 24. StrAight~-nPd portion 26 is then generally parallel to longitu.lin~l axis 14. In its defo~ cd configuration, the needle is cc ~.~.-~1 within recess 20.
Needle 4 moves from its retracted position to its exposed position by operation of ac;~ ol 8.
When manipulation end 24 is retracted within recess 20, puncture closure device 2 is in its retracted position. When the manipulation end is ~Ytçn-lçd from recess 20, the In~ ;lu~
closure device is in the exposed position.
As ~ cll~sed above, needle 4 may be constructed of a spring-like material, such as a shape memory alloy or stainless steel. The re4ui~elncnts are that the InAtÇriAl be sufficiently resilient and bio-colll~dlible. However, the needle is plef~bly constructed of a shape memory alloy, more preferably of superelastic m~tçliAI, and most preferably of an alloy 21 97(~66 inc~ in~ nickel titanium. With shape memory alloys, the radius of curvature of the S-shape can be smaller than with conventional materials, thereby pe ,..i~ g construction of a needle which has a canfiguration in which the manipulation end of the needle may be a greater n~e from the sheath and in which the length of the S-shaped needle may be shorter.
Actuator 8 includes a sleeve 28 slidable within sheath 6. The p~oxilllal portion of the sleeve may be solid or rod-like, or may be sllbst~nti~lly hollow. Sleeve 28 includes an opening 30 formed adjacent to the distal end of the sleeve, leaving a section of sleeve 32 ~ l the distal tip of the sleeve and its opening 30. Section 32 forms a ring-shaped portion encircling needle 4 which extends from distal end 12 of the sheath, through the distal tip ofthe sleeve. In its initial state, section 32 is positioned on manipulation end 24 so as to deform needle 4, thereby conaLlail~ing the needle in recess 20 in its re~t~ position.
As actuator 8 is deployed, sleeve 28 slides toward the distal end of sheath 6, ~ g the needle from section 32 and allowing needle 4 to assume its und~follllcd S-shapedconfiguration, thereby exposing the needle for use. In this position, rnanipulation end 24 extends through opening 30, as well as through recess 20. Device 2 may be returned to its initial state by sliding actuator 8 within sheath 6. With an actuation arrangement as described in the present invention, the device can be ~ctl~te~i with a short longit-l~lin~l stroke. A stop having coo~~ g surfaces on actuator 8 and sheath 6 p~ the actuator from being ~ccidçnt~lly withdrawn completely from the sheath.
Manipulation end 24 of needle 4 terrnin~t~s in a sharp point 34. Manipulation end 24 includes means for slidably receiving and ret~ining a suture 36. The means for slidably lc;cci;ving and ret~ining suture 36 may be in the form of a hole 38, as seen in the Figs. or a notch, not shown. The hole or notch is sized to accommod~te sutures of varying diameters.
~n any of these embo.~ , sharp point 3~1 is capable of piercing the tissue ~jacent to the patient's wound when çxtendecl by actualor 8 A thumb grip 40 is disposed at the proximal end of sleeve 8 for ~ ting in conjunction with gripping sections 18 of sheath 6.
In operation, puncture closure device 2 is introduced into a wound with suture 36 attached, as shQwn in Figs. 3, by threading suture 36 through hole 38 or notch) located in the manipulation end of the needle. Device 2 is positioned within the wound such that sharp point 34 is beneath the tissue to be sutured. Actuator 8 is then deployed by holding two fingers beneath gripping section 18 and using thumb grip 40 to push the ~il)p~g section and thumb grip relative to each other, so as to move needle 4 from a first position retracted within sheath 6, as seen in Fig. 3a, through an i--lf ....~ ?.te position as shown in Fig. 3b, to the exposed position as shown in Fig. 3c. However, it is to be understood that any gripping means could be employed for ~ctl-~tin~ the device, such as pistol grip, scissors action, screw mech~ni~m or plunger mec~ At this point, sharp point 34 points in the pro~il,lal direction, toward actuator 8. Device 2 is pulled upward, through tissue, from the intemal layers to the eYtem~l layers, driving sharp point 34 of needle 4 and suture 36 through one edge of the tissue surrounding the wound. A first portion of suture 36 is pulled through the tissue. The device may be t~ ily returned to the ;.~t~ ~...r, li~te position shown in Fig.
3b to facilitate suture retrieval from the wound edge. Device 2 is then pushed back through the tissue in the direction from ~ m~l tissue to internal tissue, such that the needle is no longer piercing any tissue. Suture 36 is still ~lt~çheA.. to needle 4. Device 2 is rotated within the wound. The device is again pulled upward, through the opposile edge of tissue, from intern~l layers to exten~l layers, such that the other tissue edge of the wound is pierced ~ith the sharp point of the needle, pulling the other end of suture 36 through the tissuc. The device may be again tc.llpolalily returned to its i"~ rAi~te position as seen in Fig. ~b.
Suture 36 is removed from the needle, such that suture 36 is now completely free ~rom device 2. Needle 4 is pushed back through the pierced tissue in the direction from extcmal tissue to internal tissue, fully through the internal layer so that the sharp point of thc ncedle is not piercing any tissue. Needle 4 may be returned to its re~cted position such ~hat section 32 of sleeve constrains the needle. Device 2 is fully withdrawn from the ~ ound.
Suture 34 is tied. The specific positions of Figs. 3a, 3b and 3c may be det~rrnined b anv suitable means, for example a detent between the sheath and the sleeve.
Device 2 may be constructed with double needles, as shown in Figs. 4a-4c. Fig. 4a illustrates double needles 4', 4" in the retracted position, moving through an ;"I~"..rtli~te position shown in Fig. 4b to Fig. 4c, which illustrates needles 4', 4'~ in the exposed position.
Actuation of the device may be achieved by a single actuator, as described above, or with the use of dual sleeves. Operation of the device is generally the same as that described in connection with the embodiment of Figs. 1-3.
While the needle is described as being fixed to the shea~, it is within the scope of this invention to construct the device with the needle fixed to the distal end of the a~ tor, rather than the sheath. Variations and modifications can ~e made to the present invention without dep~~ g from the scope of the present invention, which is limited only by the following claims.
This invention relates to a surgical instrument for closing the edges of a woundtogether with surgical sutures.
Rackrol-nd of the Inve~tion Minimurn invasive surgery generally includes the creation of trocar puncture wounds through the abdominal wall of a patient for insertion of a variety of surgical ins~ment~
The structural strength of the abdominal wall is derived mostly from one or more layers of fascia disposed beneath the s~in and between layers of muscle. Unless closed p,o~.ly, the abdominal contents may h~rni~te through these wounds, or body fluids can accumulate, promoting infection. Presently, ~ulgeons attempt to close trocar puncture wounds using conventional needle drivers which are often cumbersome, rnaking it difficult to plo~.ly close the wound.
Larger trocars (lOrnm and larger) are commonly used for surgical procedures. Forlarge trocars and to avoid potential h~rni~c, it is desirable to uhlize flexible threads, or sutures, passing through apposing tissue edges tied to hold the more deeply buried portions of the edge of the wound together. Attempts have been made to address these problems. for example, in U.S. Patent Nos. 5,368,601 to Sauer et al; 5,374,275 to Bradley et al; and European Patent Application No. 0 634 141. However, these devices employ multiple needles, which result in a complex device which is complicated in use and expensivc ~o m~nllf~ctl-re.
U.S. Patent No. 5,403,328 to Sh~llm~n describes a surgical a~dl~lus for closing a ~trocar incision. The Sh~llm~n device includes a curved needle pivotally positioned ~ithin a casing. The meçh~ni~m for pivoting the needle of Sh~llm~n is somewhat cumbersomc. c~cn while deflection of the needle is limited, and requires a long stroke to manipulate the nee~lc Snrnm~ly of th~ ~nv.ontiorl I have ~lesign~d a simple instrument for closing trocar incision sites and delivering sutures. The present invention is a needle assembly in which the needle is constructed of a spring-like material and initially housed within a sheath in a deformed condition. The needle can be easily exposed by sliding an actuator so as to release cor~ g means and allow the needle to assume its undeformed condition. The needle asselllbly has few parts, allows a wide range for deflection of the needle, and the needle may be exposed with a relatively short stroke.
A first aspect of the invention co...l,. ;cçs a surgical device for ~ g a wound in the tissue of a patient comrri~ing:
a sheath having a longitudinal axis in~ Air~ a p~v~illlal end and a distal end;
a recess formed in the wall of said sheath toward said distal end;
a needle constructed of a spring-like m~t,çri~l, said needle being movable from a first retracted position wherein said needle is withdrawn into said recess to a second exposed position wherein said needle is extended from said recess;
means for constraining said needle in its retracted position by defc.ll~g said needle;
an actuator at said proximal end of said sheath for r~leasi~g said COlisll~illillg means, so as to thereby allow said needle to assume its undefollllcd condition and move to said exposed position;
said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said pro~ al end.
A further aspect of the invention comprises a surgical device for s~ ring a wound in the tissue of a patient comprising:
a sheath having a longitudinal axis including a p~ hllal end and a distal end;
a recess formed in the wall of said sheath toward said distal end;
a needle constructed of a shape memory alloy m~t~.ri~l CO~ g a generally S-shape and including a body and having one end fixedly ~ ch~d to the interior of the distal end of said sheath, the body of said needle being movable in said sheath from a first position wherein said needle is retracted into said recess to a second position t;A~osed wherein said needle is ex~n~d laterally from said recess;
means for cor~ll~ ing said needle in its retracted;
an actuator at said proximal end of said sheath for rele~cin~ said cG~ -g means, said a ;~ lor comprising:
a sleeve slidable within said sheath;
an opening formed in the distal end of said sleeve through which said needle extends in the exposed position;
wherein said means for co~l~ g cu...l..;~s a section of said sleeve formed ~1~ ~ ~ n said opening and the distal end of said ~ or such that upon release of said means for co~ i,ling said needle moves to said second, exposed position;
said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said pro~ al end.
Brief T )escription of th-o ~rawin~(s) Fig. 1 is a ~l~cctive view of the present invention.
Fig. 2 is an exploded view of device of Fig. 1.
Figs. 3a, 3b and 3c are scll~om~tic views of deployment of the present invention.
Figs. 4a, 4b and 4c are s~hem~tic views of a second embodiment of the present invention.
Description of the P~eff .ed Fmho-limf~nt~
Referring now to the drawings, Fig. 1 illustrates a surgical device in the form of a puncture closure device 2 including a needle 4 movable in sheath 6. An actuator 8 is capable of moving needle 4 from a first, retracted position, as seen in Fig. 3a, to a second, eYrose~1 position, as seen in Figs. 1 and 3c. Device 2 is dçci~ed to be used in a sterile surgical field. The device may be disposable or reusable or partially ~licpos~ble or reusable.
The outer radial-lim~n~ion of device 2 is lOmm or less.
Sheath 6 is a tubular sheath having a proximal end 10 and a distal end 12 disposed along opposite ends of longit~ inAI axis 14. Sheath 6 in~ dçc a blunt tip 16 located at the distal end and a gripping section 18 located at the l)roxilllal end. The allv~ge of a blunt end is to eliminAte risk of inadvertent puncture of organs or tissue when inserting the device into a wound. A recess 20 is formed in the wall of the sheath ~ljflc~nt to blunt tip 16 through which needle 4 may be ~tçrl~ed as seen in the Figures and as rliecllcc-ed below.
Needle 4 includes a body having a generally S-shaped configuration. A first end 22 of needle 4 is fixedly ~tt~ched to the interior of the distal end of the sheath. Needle 4 may be fixedly AttAc~d to sheath 6 at end 22 by pins or other ~ fltt~l....~..l, or may be formed with the sheath. The end opposite first end 22 of needle 4 is rnanipulation end 24, which includes a straightened portion 26. It should be noted, however, that the manipulation end may include a curved portion, rather than strAighhon~l portion 26. Needle 4 is constructed of a spring-like mAt~riAl In its llnr~efo.. l~A configuration, needle 4 A~.. ÇS
its S-shaped configuration exposed so that the S-shape extends f~om fixed end 22 through recess 20 to manipulation end 24. StrAight~-nPd portion 26 is then generally parallel to longitu.lin~l axis 14. In its defo~ cd configuration, the needle is cc ~.~.-~1 within recess 20.
Needle 4 moves from its retracted position to its exposed position by operation of ac;~ ol 8.
When manipulation end 24 is retracted within recess 20, puncture closure device 2 is in its retracted position. When the manipulation end is ~Ytçn-lçd from recess 20, the In~ ;lu~
closure device is in the exposed position.
As ~ cll~sed above, needle 4 may be constructed of a spring-like material, such as a shape memory alloy or stainless steel. The re4ui~elncnts are that the InAtÇriAl be sufficiently resilient and bio-colll~dlible. However, the needle is plef~bly constructed of a shape memory alloy, more preferably of superelastic m~tçliAI, and most preferably of an alloy 21 97(~66 inc~ in~ nickel titanium. With shape memory alloys, the radius of curvature of the S-shape can be smaller than with conventional materials, thereby pe ,..i~ g construction of a needle which has a canfiguration in which the manipulation end of the needle may be a greater n~e from the sheath and in which the length of the S-shaped needle may be shorter.
Actuator 8 includes a sleeve 28 slidable within sheath 6. The p~oxilllal portion of the sleeve may be solid or rod-like, or may be sllbst~nti~lly hollow. Sleeve 28 includes an opening 30 formed adjacent to the distal end of the sleeve, leaving a section of sleeve 32 ~ l the distal tip of the sleeve and its opening 30. Section 32 forms a ring-shaped portion encircling needle 4 which extends from distal end 12 of the sheath, through the distal tip ofthe sleeve. In its initial state, section 32 is positioned on manipulation end 24 so as to deform needle 4, thereby conaLlail~ing the needle in recess 20 in its re~t~ position.
As actuator 8 is deployed, sleeve 28 slides toward the distal end of sheath 6, ~ g the needle from section 32 and allowing needle 4 to assume its und~follllcd S-shapedconfiguration, thereby exposing the needle for use. In this position, rnanipulation end 24 extends through opening 30, as well as through recess 20. Device 2 may be returned to its initial state by sliding actuator 8 within sheath 6. With an actuation arrangement as described in the present invention, the device can be ~ctl~te~i with a short longit-l~lin~l stroke. A stop having coo~~ g surfaces on actuator 8 and sheath 6 p~ the actuator from being ~ccidçnt~lly withdrawn completely from the sheath.
Manipulation end 24 of needle 4 terrnin~t~s in a sharp point 34. Manipulation end 24 includes means for slidably receiving and ret~ining a suture 36. The means for slidably lc;cci;ving and ret~ining suture 36 may be in the form of a hole 38, as seen in the Figs. or a notch, not shown. The hole or notch is sized to accommod~te sutures of varying diameters.
~n any of these embo.~ , sharp point 3~1 is capable of piercing the tissue ~jacent to the patient's wound when çxtendecl by actualor 8 A thumb grip 40 is disposed at the proximal end of sleeve 8 for ~ ting in conjunction with gripping sections 18 of sheath 6.
In operation, puncture closure device 2 is introduced into a wound with suture 36 attached, as shQwn in Figs. 3, by threading suture 36 through hole 38 or notch) located in the manipulation end of the needle. Device 2 is positioned within the wound such that sharp point 34 is beneath the tissue to be sutured. Actuator 8 is then deployed by holding two fingers beneath gripping section 18 and using thumb grip 40 to push the ~il)p~g section and thumb grip relative to each other, so as to move needle 4 from a first position retracted within sheath 6, as seen in Fig. 3a, through an i--lf ....~ ?.te position as shown in Fig. 3b, to the exposed position as shown in Fig. 3c. However, it is to be understood that any gripping means could be employed for ~ctl-~tin~ the device, such as pistol grip, scissors action, screw mech~ni~m or plunger mec~ At this point, sharp point 34 points in the pro~il,lal direction, toward actuator 8. Device 2 is pulled upward, through tissue, from the intemal layers to the eYtem~l layers, driving sharp point 34 of needle 4 and suture 36 through one edge of the tissue surrounding the wound. A first portion of suture 36 is pulled through the tissue. The device may be t~ ily returned to the ;.~t~ ~...r, li~te position shown in Fig.
3b to facilitate suture retrieval from the wound edge. Device 2 is then pushed back through the tissue in the direction from ~ m~l tissue to internal tissue, such that the needle is no longer piercing any tissue. Suture 36 is still ~lt~çheA.. to needle 4. Device 2 is rotated within the wound. The device is again pulled upward, through the opposile edge of tissue, from intern~l layers to exten~l layers, such that the other tissue edge of the wound is pierced ~ith the sharp point of the needle, pulling the other end of suture 36 through the tissuc. The device may be again tc.llpolalily returned to its i"~ rAi~te position as seen in Fig. ~b.
Suture 36 is removed from the needle, such that suture 36 is now completely free ~rom device 2. Needle 4 is pushed back through the pierced tissue in the direction from extcmal tissue to internal tissue, fully through the internal layer so that the sharp point of thc ncedle is not piercing any tissue. Needle 4 may be returned to its re~cted position such ~hat section 32 of sleeve constrains the needle. Device 2 is fully withdrawn from the ~ ound.
Suture 34 is tied. The specific positions of Figs. 3a, 3b and 3c may be det~rrnined b anv suitable means, for example a detent between the sheath and the sleeve.
Device 2 may be constructed with double needles, as shown in Figs. 4a-4c. Fig. 4a illustrates double needles 4', 4" in the retracted position, moving through an ;"I~"..rtli~te position shown in Fig. 4b to Fig. 4c, which illustrates needles 4', 4'~ in the exposed position.
Actuation of the device may be achieved by a single actuator, as described above, or with the use of dual sleeves. Operation of the device is generally the same as that described in connection with the embodiment of Figs. 1-3.
While the needle is described as being fixed to the shea~, it is within the scope of this invention to construct the device with the needle fixed to the distal end of the a~ tor, rather than the sheath. Variations and modifications can ~e made to the present invention without dep~~ g from the scope of the present invention, which is limited only by the following claims.
Claims (19)
1. A surgical device for suturing a wound in the tissue of a patient comprising:
a sheath having a longitudinal axis including a proximal end and a distal end;
a recess formed in the wall of said sheath toward said distal end;
a needle constructed of a spring-like material, said needle being movable from a first retracted position wherein said needle is withdrawn into said recess to a second exposed position wherein said needle is extended from said recess;
means for constraining said needle in its retracted position by deforming said needle;
an actuator at said proximal end of said sheath for releasing said constraining means, so as to thereby allow said needle to assume its undeformed condition and move to said exposed position;
said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said proximal end.
a sheath having a longitudinal axis including a proximal end and a distal end;
a recess formed in the wall of said sheath toward said distal end;
a needle constructed of a spring-like material, said needle being movable from a first retracted position wherein said needle is withdrawn into said recess to a second exposed position wherein said needle is extended from said recess;
means for constraining said needle in its retracted position by deforming said needle;
an actuator at said proximal end of said sheath for releasing said constraining means, so as to thereby allow said needle to assume its undeformed condition and move to said exposed position;
said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said proximal end.
2. The surgical device as defined in claim 1 wherein said spring-like material is a shape memory alloy.
3. The surgical device as defined in claim 2 wherein said shape memory alloy is superelastic.
4. The surgical device as defined in claim 2 wherein said shape memory alloy is made from an alloy including nickel titanium.
5. The surgical device as defined in claim 1 wherein one end of said needle is fixedly attached to the interior of the distal end of said sheath.
6. The surgical device as defined in claim 1 wherein said actuator comprises:
a sleeve slidable within said sheath;
an opening formed in the distal end of said sleeve through which said needle extends in the exposed position;
wherein said means for constraining comprises a section of said sleeve formed between said opening and the distal end of said actuator.
a sleeve slidable within said sheath;
an opening formed in the distal end of said sleeve through which said needle extends in the exposed position;
wherein said means for constraining comprises a section of said sleeve formed between said opening and the distal end of said actuator.
7. The surgical device as defined in claim 1 wherein in the exposed position, the needle extends outwardly of said sheath.
8. The surgical device as defined in claim 1 wherein in the exposed position, said needle is spaced from the longitudinal axis of said sheath.
9. The surgical device as defined in claim 1 wherein said needle configuration is an S-shape.
10. The surgical device as defined in claim 9 further including a straightened portion at a manipulation end of said needle such that said manipulation end is generally parallel to the longitudinal axis of said sheath.
11. The surgical device as defined in claim 1 wherein said sheath includes a blunt tip.
12. The surgical device as defined in claim 1 wherein said device includes a pair of needles.
13. The surgical device as defined in claim 1 further comprising means for receiving a suture.
14. A surgical device for suturing a wound in the tissue of a patient comprising:
a sheath having a longitudinal axis including a proximal end and a distal end;a recess formed in the wall of said sheath toward said distal end;
a needle constructed of a shape memory alloy material comprising a generally S-shape and including a body and having one end fixedly attached to the interior of the distal end of said sheath, the body of said needle being movable in said sheath from a first position wherein said needle is retracted into said recess to a second position exposed wherein said needle is extended laterally from said recess;
means for constraining said needle in its retracted;
an actuator at said proximal end of said sheath for releasing said constraining means, said actuator comprising:
a sleeve slidable within said sheath;
an opening formed in the distal end of said sleeve through which said needle extends in the exposed position;
wherein said means for constraining comprises a section of said sleeve formed between said opening and the distal end of said actuator such that upon release of said means for constraining said needle moves to said second, exposedposition;
said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said proximal end.
a sheath having a longitudinal axis including a proximal end and a distal end;a recess formed in the wall of said sheath toward said distal end;
a needle constructed of a shape memory alloy material comprising a generally S-shape and including a body and having one end fixedly attached to the interior of the distal end of said sheath, the body of said needle being movable in said sheath from a first position wherein said needle is retracted into said recess to a second position exposed wherein said needle is extended laterally from said recess;
means for constraining said needle in its retracted;
an actuator at said proximal end of said sheath for releasing said constraining means, said actuator comprising:
a sleeve slidable within said sheath;
an opening formed in the distal end of said sleeve through which said needle extends in the exposed position;
wherein said means for constraining comprises a section of said sleeve formed between said opening and the distal end of said actuator such that upon release of said means for constraining said needle moves to said second, exposedposition;
said needle having a configuration such that upon extension from said distal end of said sheath, said needle points in the direction of said proximal end.
15. The surgical device as defined in claim 14 wherein said needle is in a deformed condition in the retracted position and assumes its undeformed condition in the exposed position.
16. The surgical device as defined in claim 14 wherein said body of said needle includes a straightened portion at a manipulation end of said needle such that said manipulation end of said needle is generally parallel to the longitudinal axis of said sheath in said exposed position.
17. The surgical device as defined in claim 14 wherein said sheath includes a blunt tip.
18. The surgical device as defined in claim 14 wherein said device includes a pair of needles.
19. The surgical device as defined in claim 14 further comprising means for receiving a suture.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US47461395A | 1995-06-07 | 1995-06-07 | |
| US08/474,613 | 1995-06-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2197066A1 true CA2197066A1 (en) | 1996-12-19 |
Family
ID=23884293
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002197066A Abandoned CA2197066A1 (en) | 1995-06-07 | 1996-05-20 | Wound closure device |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US5817108A (en) |
| EP (1) | EP0774922B1 (en) |
| JP (1) | JP3729861B2 (en) |
| AT (1) | ATE222076T1 (en) |
| CA (1) | CA2197066A1 (en) |
| DE (1) | DE69622969T2 (en) |
| WO (1) | WO1996039946A1 (en) |
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-
1996
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- 1996-05-20 WO PCT/US1996/007318 patent/WO1996039946A1/en active IP Right Grant
- 1996-05-20 DE DE69622969T patent/DE69622969T2/en not_active Expired - Lifetime
- 1996-05-20 CA CA002197066A patent/CA2197066A1/en not_active Abandoned
- 1996-05-20 EP EP96916518A patent/EP0774922B1/en not_active Expired - Lifetime
- 1996-05-20 AT AT96916518T patent/ATE222076T1/en not_active IP Right Cessation
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1997
- 1997-05-19 US US08/858,782 patent/US5817108A/en not_active Expired - Lifetime
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1998
- 1998-10-05 US US09/166,619 patent/US6113610A/en not_active Expired - Lifetime
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| JP3729861B2 (en) | 2005-12-21 |
| JPH10504222A (en) | 1998-04-28 |
| ATE222076T1 (en) | 2002-08-15 |
| EP0774922B1 (en) | 2002-08-14 |
| DE69622969D1 (en) | 2002-09-19 |
| US5817108A (en) | 1998-10-06 |
| US6113610A (en) | 2000-09-05 |
| EP0774922A1 (en) | 1997-05-28 |
| WO1996039946A1 (en) | 1996-12-19 |
| DE69622969T2 (en) | 2003-04-24 |
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