US20080082105A1 - Systems, devices and methods for treating pelvic floor disorders - Google Patents
Systems, devices and methods for treating pelvic floor disorders Download PDFInfo
- Publication number
- US20080082105A1 US20080082105A1 US11/906,969 US90696907A US2008082105A1 US 20080082105 A1 US20080082105 A1 US 20080082105A1 US 90696907 A US90696907 A US 90696907A US 2008082105 A1 US2008082105 A1 US 2008082105A1
- Authority
- US
- United States
- Prior art keywords
- shaft
- implant
- head
- delivery device
- region
- 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
Images
Classifications
-
- 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
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
- A61F2/0045—Support slings
-
- 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
- A61B17/04—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
- A61B17/06109—Big needles, either gripped by hand or connectable to a handle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0042—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
- A61B2017/00424—Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping ergonomic, e.g. fitting in fist
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00805—Treatment of female stress urinary incontinence
-
- 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
- A61B2017/06076—Needles, e.g. needle tip configurations helically or spirally coiled
-
- 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
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2926—Details of heads or jaws
- A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
Definitions
- Pelvic floor disorders afflict many women. According to some studies, about 1 out of 11 women needs surgery for a pelvic floor disorder during her lifetime.
- the pelvic floor generally includes muscles, ligaments, and tissues that collectively act to support anatomical structures of the pelvic region, including the uterus, the rectum, the bladder, and the vagina.
- Pelvic floor disorders include vaginal prolapse, vaginal hernia, cystocele, rectocele, and enterocele. Such disorders are characterized in that the muscles, ligaments and/or tissues are damaged, stretched, or otherwise weakened, which causes the pelvic anatomical structures to fall or shift and protrude into each other or other anatomical structures.
- UI urinary incontinence
- SID stress urinary incontinence
- hypernobility hypernobility
- the pelvic floor In hypermobility, the pelvic floor is distended, weakened, or damaged, resulting in increases in intra-abdominal pressure (e.g., due to sneezing, coughing, straining, etc.) and consequently the bladder neck and proximal urethra rotate and descend. As a result, the urethra does not close with sufficient response time, and urine leaks through the urethra.
- intra-abdominal pressure e.g., due to sneezing, coughing, straining, etc.
- UI and pelvic floor disorders which are usually accompanied by significant pain and discomfort, are typically treated by implanting a supportive sling in or near the pelvic floor region to support the fallen or shifted anatomical structures or to, more generally, strengthen the pelvic region by, for example, promoting tissue ingrowth.
- treatments of stress incontinence are made without treating the pelvic floor disorders at all, potentially leading to an early recurrence of the pelvic floor disorder.
- Existing devices, methods, and kits for treatment typically apply delivery devices to position a supportive sling into a desired position in the pelvic region.
- these devices may be difficult for a surgeon to manipulate within the posterior pelvic region without adversely affecting surrounding anatomical structures during the delivery process.
- surgical kits do not provide devices that are suitably sized and/or shaped.
- surgeons have limited ability to access different locations in the pelvic region. Accordingly, medical operators and patients need improved systems, methods, and surgical kits for the treatment of pelvic floor disorders and/or urinary incontinence.
- the invention generally pertains to devices, systems, and methods to deliver surgical implants within patients.
- the devices include delivery devices which can be used to implant a supportive mesh in the pelvic region of a patient for pelvic floor repair and/or for treatment of urinary incontinence.
- the devices also include surgical implants that are sized, shaped, and constructed to support various organs within the pelvic region of a patient, or more generally to promote tissue growth within and generally stabilize the pelvic region.
- the invention includes a delivery device for delivering an implantable sling to an anatomical location within a patient.
- the devise includes a shaft having a distal end and a proximal end, a head having a curved region, a tip disposed at a distal end of the curved region, and a substantially linear region at a proximal end of the curved region, and a curved junction connecting the proximal end of the curved region and the distal end of the shaft, wherein an axis of the substantially linear region is perpendicular to a longitudinal axis of the shaft.
- the delivery device includes a shaft having a distal end and a proximal end, a rotatable head distal to the shaft including a tip at a distal end of the head, and a pivotable junction connecting the head and the shaft.
- the rotatable head may include a curved region. In one feature, the rotatable head is rotatable about the distal end of the shaft. The curved regions may be semi-circular.
- the tips employed with the device are equiplanar with the longitudinal axis of the shaft portion.
- the head lies in a plane, and the longitudinal axis of the shaft portion is normal to the plane.
- the head may extend in a counterclockwise path from the distal end of the shaft, or the head may extend in a clockwise path from the distal end of the shaft.
- the head lies in a plane, and the longitudinal axis of the shaft has a non-normal incidence with the plane.
- the device may be used to implant a sling within a patient.
- the device may include other components such as stopping mechanisms, implant associators, and soft tissue anchors adapted to aid the implantation of the sling.
- the invention includes methods for delivering to a patient an implant having a central region and at least four extension/appendage regions.
- the methods include securing a first extension of the implant to at least one of a sacrospinous ligament, a coccygeus muscle, an ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani muscle on a first side of a patient, securing a second extension of the implant to at least one of a sacrospinous ligament, a coccygeus muscle, an ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani muscle on a contra-lateral side of the patient, delivering a third extension of the implant through an obturator foramen on the first side of the patient, and delivering a fourth extension of the implant through an obturator foramen on the contra-lateral side of the patient.
- the methods include securing the first extension with a first delivery device, securing the second extension with a second delivery device different from the first delivery device, and delivering the third extension with a third delivery device different from the first delivery device and different from the second delivery device.
- the methods may also include securing a fifth extension to at least one of a sacrospinous ligament, a coccygeus muscle, an ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani muscle on the first side of a patient, and securing a sixth extension to at least one of a sacrospinous ligament, a coccygeus muscle, an ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani muscle on the contra-lateral side of the patient.
- the methods contemplate the use of a plurality of devices having different lengths.
- the methods include securing a fifth extension with a delivery device different from the first delivery device, different from the second delivery device, and different from the third delivery device.
- the methods include associating the respective first or second extension with a delivery device including a head, the head portion including a tip, and driving the tip of the delivery device through the respective sacrospinous ligament, coccygeus muscle, or levator ani muscle. This may include placing the tip against the respective sacrospinous ligament, coccygeus muscle, or levator ani muscle, and applying pressure directly on the head.
- at least one of securing the first extension and securing the second extension may include suturing the respective first or second extension to the respective sacrospinous ligament, coccygeus muscle, or levator ani muscle.
- the invention includes a surgical kit having one or more of the devices described herein for use in delivering an implant within a patient.
- the kit includes a first delivery device having a first shaft for delivering a first implant region, and a second delivery device having a second shaft for delivering a second implant region.
- the kit may include a third delivery device having a third shaft for delivering a third implant region.
- the shafts are provided with differing lengths.
- one shaft is more than about 20% longer than one or more other shafts in the kit.
- the kit may also include an implant, and optionally, other devices for assisting in the exemplary surgical procedures.
- Methods for associating the delivery devices with the implants, methods for delivering the implants to desired locations within a patient, and methods for positioning, tensioning, and/or fixating the implants within a patient are also contemplated.
- Exemplary applications of the devices and methods include the treatment of conditions such as prolapse, vaginal hernia, cystocele, rectocele, enterocele, and urinary incontinence.
- FIG. 1A shows a delivery device for delivering a pelvic floor implant to an anatomical location.
- FIG. 1B illustrates another embodiment of a delivery device for delivering a pelvic floor implant to an anatomical location.
- FIGS. 2A-2B show close-up views of the head portions of an exemplary pelvic floor delivery device.
- FIG. 3 shows an alternative embodiment of an exemplary pelvic floor delivery device having a head oriented perpendicularly to a shaft.
- FIG. 4 shows an alternative configuration of the device of FIG. 3 having a head oriented on a contra-lateral side of the shaft.
- FIG. 5 shows an exemplary pelvic floor device and an implantable mesh strap assembly including an implant associator.
- FIG. 6 shows the delivery device of FIG. 5 coupled with the mesh strap of FIG. 5 .
- FIG. 7 shows the mesh strap of FIG. 5 , with an alternative implant associator.
- FIG. 8 illustrates the use of an exemplary pelvic floor device in implanting a mesh strap into tissue.
- FIG. 9 shows an alternative embodiment of a pelvic floor delivery device having a rotatable head.
- FIG. 10 illustrates the use of the device of FIG. 9 in penetrating tissue.
- FIG. 11 shows the device of FIG. 9 in association with a mesh strap implant associator and penetrating through a target ligament.
- FIG. 12 shows a Miya device which may be used to place one or more mesh straps of an implant.
- FIG. 13A illustrates an inferior view of a sling implanted within a patient using a device according to the invention.
- FIG. 13B illustrates a lateral view of the sling implant illustrated in FIG. 13A .
- FIG. 14 illustrates a surgical kit for use in pelvic floor repair.
- FIGS. 15A-15B show delivery devices for delivering an anterior implant strap.
- FIGS. 16A-16C show various views of a delivery device for delivering anterior implant straps.
- the devices, methods, and kits of this invention are generally used to deliver a surgical implant, such as an implantable sling, to the pelvic region of a patient for pelvic floor repair and/or for treatment of urinary incontinence.
- the devices include improved delivery tools that are sized and shaped to deliver the surgical implant to the pelvic region, and improved surgical implants sized, shaped, and constructed to support various organs within the pelvic region, or more generally to promote tissue growth in and the general stability of the pelvic region.
- the implant includes a central region and a plurality of extensions, such as mesh straps, that extend from the central region and are anchored at respective locations in the pelvic region of a patient to appropriately position and/or tension the implant.
- the extensions are anchored to the patient's pelvic floor using delivery devices that drive the extensions through the tissues, ligaments, and/or muscle regions thereof.
- the devices may be configured to allow the operator to deliver and secure the implant to posterior regions of the pelvic floor, such as the sacrospinous ligament, the coccygeus muscle, the ischiococcygeus muscle, the iliococcygeus mscule, and the tendinous arch of the levator ani muscle.
- posterior regions of the pelvic floor such as the sacrospinous ligament, the coccygeus muscle, the ischiococcygeus muscle, the iliococcygeus mscule, and the tendinous arch of the levator ani muscle.
- Such anatomical locations are useful locations for anchoring the straps of pelvic floor implants within the pelvic region.
- An operator accesses these anatomical locations by guiding the devices through a vaginal incision.
- Methods for associating the delivery devices with the implants, methods for delivering the implants to desired locations within a patient, and methods for positioning, tensioning, and/or fixating the implants within a patient are described.
- the delivery devices used to implant the various extension need not be the same, and in one implementation, a surgical kit including three delivery devices is provided. In such implementations, each of these devices are sized and shaped to facilitate delivery to certain ones of the tissue regions.
- FIG. 1A depicts an exemplary embodiment of a device 100 that is adapted to deliver, through a vaginal incision, a mesh strap to a target tissue region of the sacrospinous ligament.
- the sacrospinous ligament is a thin and triangular tissue that is attached by its apex to the spine of the patient's ischium, and medially, by its broad base, to the lateral margins of the sacrum and coccyx in front of the sacrotuberous ligament.
- the sacrospinous ligament is a convenient location to anchor mesh straps in the posterior regions of the pelvic floor in order to provide posterior support.
- the device 100 may also be adapted to deliver, through a vaginal incision, a mesh strap to a target tissue region of the coccygeus (or ischiococcygeus) muscle.
- the coccygeus muscle is a triangular muscle that originates from the ischial spine and the sacrospinous ligament and the coccyx, and inserts on the lateral aspects of the lower sacrum and the upper coccyx.
- the delivery device 100 includes a shaft 105 , a handle 122 , a head 120 for attaching to an implant and delivering the implant to the patient's anatomy, and a curved junction 124 configured within an arc that allows the head 120 to penetrate the patient's anatomy.
- the shaft 105 includes a distal end 105 a, a proximal end 105 b, and a longitudinal axis 111 .
- the shaft 105 has a length 107 that is substantially longer than the length 108 of the head 120 .
- the relatively long shaft length 107 allows an operator to insert the device through the vaginal cavity of a patient and place the head 120 within the posterior pelvic region in proximity to the sacrospinous ligament or the coccygeus muscle.
- the shaft 105 is shown to be substantially linear, but it may be slightly curved to form either a convex or a concave arc to further facilitate delivery of the head .
- FIG. 1B illustrates an alternate embodiment 101 of the delivery device 100 of FIG. 1A having a curved shaft 103 instead of the linear shaft 105 of FIG. 1A .
- the curved shaft 103 may facilitate passage of the device through the vaginal canal to access the sacrospinous ligament or coccygeus muscle of the patient.
- the curved shaft allows rotation of the delivery device 101 for insertion of the head 120 into the patient's tissues.
- This may be done, for example, by applying a force in direction 140 to the proximal end 103 b of the device 101 thereby rotating the device about the middle area 103 c of the shaft 103 such that the distal end 103 a of the shaft 103 and the head 120 rotate into the tissues in the direction 141 .
- the amount of curvature will typically be chosen to facilitate delivery of the device into the patient using a preferred method and path of insertion, described in exemplary embodiments below.
- the shaft 105 also has a circular cross-section 113 with a radius selected as needed to suit an intended path and location for delivery of the implant.
- the radius is about 0.05 inches, about 0.0625 inches, or about 0.075 inches which allows the device 100 to be inserted through a vaginal incision and into the sacrospinous ligament or coccygeus muscle, as described more particularly in connection with FIGS. 13A-13B .
- the radius is about 0.5 inches or less. In certain embodiments, the radius is about 0.125 inches. In certain embodiments, the radius is between about 0.01 inches and about 0.5 inches, or as otherwise desired to aid in implantation within other pelvic floor areas.
- the device includes a handle 122 that is configured to allow an operator to grasp and manipulate the device as required to deliver a surgical implant to a desired location in a patient's anatomy.
- the handle 122 is generally a looped region of the shaft 105 at the proximal end 105 b of the shaft 105 .
- the depicted handle 122 is not intended to be limiting and other suitable handle configurations can be used.
- the device 100 can include the handle 119 of the device 300 illustrated in FIG. 8 .
- the handle 119 is sized and shaped to be comfortably grasped and manipulated by an operator.
- the handle can be made of a single material, or a combination of materials. Exemplary materials include acrylonitrile butadiene styrene and soft durometer TPE. Other suitable materials may be used, including thermoplastic materials and other materials suitable for surgical environments.
- the device 100 includes a head 120 that is configured to enable an operator to deliver and secure an implant to a desired anatomical structure in the body, such as a region of the sacrospinous ligament, coccygeus muscle, or other positions within the pelvic region. More particularly, the head 120 includes a curved region 120 a, a substantially linear region 120 b at a proximal end of the curved region 120 a, and an end region 120 c at a distal end of the curved region 120 a. The depicted curved region 120 a is C-shaped.
- the substantially linear region 120 b of the head 120 is configured to have a desired length.
- the region 120 b shown in FIG. 1A is between about 0.125 inches and about 0.5 inches in length to allow the head 120 to fit properly through the sacrospinous ligament or coccygeus muscle, though this length can be larger or smaller as desired.
- the substantially linear region 120 b includes a longitudinal axis 123 oriented to be substantially perpendicular to the longitudinal axis 111 of the shaft 105 .
- the axes 111 and 123 are not perpendicular, but intersect at angles of about 90° or at an angle chosen to suit an intended path and location for delivery of the implant.
- the length 107 of the shaft 105 along the axis 111 is about ten times longer than the length 108 of the head 120 along the axis 111 .
- the head 120 also includes an end region 120 c.
- FIG. 2A shows a close-up view of the head 120 of the device 100 and in particular, the end region 120 c.
- the end region 120 c has a tip 130 that extends along a longitudinal axis 131 which intersects the longitudinal axis 111 of the shaft 105 , such that the end of the tip 130 is substantially equiplanar with the longitudinal axis 111 .
- the tip 130 is sharp and configured to dissect tissue material, including contractile tissue, epithelium, and/or connective tissue.
- the tip 130 is preferably sharp enough to dissect muscle and ligament.
- the tip 130 is associated with an implant and driven through a target region in the sacrospinous ligament, coccygues muscle, iliococcygeus muscle, and/or the levator ani muscle.
- the tip 130 is blunt, allowing for the blunt dissection of tissue.
- the tip 130 further includes a shoulder 225 which provides a stopping mechanism for an implant associator of a surgical implant, as discussed below with reference to FIGS. 5-6 .
- the shoulder 225 is generally shaped as a circular step that juts out from the tip 130 , resulting in the end-region 120 c having varying cross-sections. More specifically, a cross section 134 of the device taken in a location proximal to the shoulder (i.e., away from the tip) has a larger radius than a radius of a cross section 136 of the device taken in a location just distal to the shoulder (i.e., toward the tip).
- the device 100 also includes a junction 124 that connects the head 120 and the shaft 105 , and in particular connects the substantially linear region 120 b of the head 120 to the distal end 105 a of the shaft 105 .
- the depicted junction 124 is curved.
- the junction 124 has a radius of curvature 140 between about 0.1 inches and about 0.7 inches.
- the radius of curvature 140 may be smaller or larger than the radius of curvature 121 of the curved region 120 a.
- the junction 124 alternatively need not be curved at all. Instead, the junction 124 may include an angled junction formed by the substantially linear region 120 b and the shaft 105 , with no intervening curvature.
- the appropriate radius of curvature 140 or angle of the junction 124 can be chosen to suit a preferred method and location of delivery of the surgical implant.
- the junction 124 may also include a hinge about which the head 120 is rotatable.
- FIG. 3 shows an alternative embodiment 300 of the device of FIG. 1A having a head 320 oriented perpendicularly to the shaft 305 to allow the operator to deliver a surgical implant to a region of a patient's levator ani muscle, such as the tendinous arch of the levator ani or the iliococcygeus muscle, through a vaginal incision.
- the levator ani muscle is a broad, thin muscle situated generally on the side of the pelvis that is attached to the inner surface of the lesser pelvis. It is a convenient location to anchor mesh straps in order to provide lateral and/or posterior support and tension for a surgical implant.
- the iliococcygeus is a portion of the levator ani muscle originating from the ischial spine and the arcus tendineus levator ani and sloping inferiorly toward the midline.
- the iliococcygeus includes fibers that blend with the longitudinal muscle of the rectum.
- the delivery device 300 is similar to the device 100 , but its head 320 is positioned about 90 degrees clockwise 350 with respect to the operator of the device to allow the head 320 to align next to the levator ani muscle when the device 300 is passed through a vaginal incision.
- the head 320 of the device 300 lies substantially in a plane, and the longitudinal axis 311 of the shaft 305 is normal to the plane.
- the head 320 traces a counter clockwise 360 path from its linear region 320 b to its tip 330 with respect to a distally-looking vantage of the delivery device (i.e., with respect to an operator's vantage).
- This configuration allows the operator to position the implant through a vaginal incision next to the levator ani muscle so the head 120 (coupled to the implant strap) can be driven into the muscle, thereby inserting the strap into the muscle to secure the implant.
- FIG. 4 shows an alternative embodiment 400 of the device 100 of FIG. 1 a having a head 420 oriented on the contra lateral side of its shaft 405 compared to the head 320 and shaft 305 of FIG. 3 .
- the device 400 is then suited to deliver a surgical implant, such as a pelvic floor mesh strap, to a region of a patient's levator ani muscle contra-lateral to the region of the levator ani muscle discussed with respect to FIG. 3 .
- the delivery device 400 is similar to the device 100 , but with the head 420 rotated by about 90 degrees counterclockwise 450 with respect to the operator of the device.
- the head 420 of the device 400 lies substantially in a plane, and the longitudinal axis 411 of the shaft 405 is normal to the plane.
- the head 420 traces a clockwise 460 path from the linear region 420 b to the tip 430 , with respect to a distally-looking vantage of the delivery device (i.e., with respect to an operator's vantage).
- This configuration allows the operator to position the implant through a vaginal incision and next to the levator ani muscle, so the head 120 (with the implant strap) can be driven into the muscle, thereby inserting the strap into the muscle to secure the implant.
- the head can be rotated by more or less than 90 degrees in either the counterclockwise 450 or clockwise 350 directions to allow the implant or its straps to be inserted within any ligaments, muscles or other desired pelvic tissues.
- the heads will lie substantially in a plane, and the respective longitudinal axes of the shaft will have a non-normal incidence with the plane.
- the appropriate incidence angle can be chosen to facilitate insertion of the device using a preferred method and location for delivery.
- the shafts 305 and 405 of the delivery devices 300 and 400 are of about equal length and are shorter in length than the shaft 105 of the delivery device 100 . This is beneficial because the sacrospinous ligament and coccygeus muscle are located posterior to the tendinous arch of the levator ani muscle and the iliococcygeus muscle.
- the shafts 305 and 405 are, in certain embodiments, about 8 times longer than respective heads 320 and 420 .
- the shaft 105 is generally between about 15% and about 50% longer than the shafts 305 and 405 , and in some embodiments is about 20% longer than the shafts 305 and 405 .
- FIG. 5 more particularly shows an exemplary device, such as the device 100 of FIG. 1A , in operation with an implantable mesh strap assembly including an implant 505 .
- the depicted implant 505 is a mesh strap 505 portion of a surgical implant assembly that can be used to treat pelvic floor disorders, UI, or other conditions.
- the implant 505 is configured to couple with the tip 130 of device 100 for delivery of the implant 505 to a target tissue region. It is to be understood that the other tips 330 and 430 of devices 300 and 400 respectively, as well as other device tips discussed herein, can be used in similar operative combinations with surgical implants such as mesh strap 505 .
- the mesh strap 505 includes an implant associator 510 for associating with the tip 130 of the delivery device 100 , and in certain embodiments the implant associator 510 also anchors the mesh strap 505 in tissue.
- the depicted implant associator 510 has a ring 509 and wings 511 a and 511 b. In operation, an operator places the ring 509 over the tip 130 and the ring 509 slides down the tip 130 until the ring 509 abuts the shoulder 225 . The step or shoulder 225 of the end-region 120 c prevents passage of the ring 509 in a direction that is proximal and further down 515 along the delivery device.
- the ring 509 includes an inner surface 507 that is tapered, and thereby the ring 509 inter-fits with the outer surface 226 of the tip 130 .
- the depicted ring 509 is coplanar with the mesh strap 505 .
- the wings 511 a and 511 b of the implant associator 510 extend radially from the ring 509 and form an angle 512 .
- the angle allows the wings 511 a and 511 b to be inserted within a patient's tissue to secure the mesh strap 505 in a desired location.
- the implant associator 510 is flexible such that the angle 512 can be increased or decreased upon application of appropriate mechanical pressure.
- the wings 511 a and 511 b interact with the tissue to reduce the angle 512 .
- the wings 511 a and 511 b interact with the tissue to increase the angle 512 .
- the varying angle 512 facilitates movement of the mesh strap 505 in the forward direction 580 , and impedes movement of the mesh strap 505 in the retrograde direction 582 .
- the angle 512 formed between the wings 511 a and 511 b can be configured so that it varies, as can the flexibility of the connector 505 . These properties are generally chosen to suit the particular delivery path location for delivering the implant, as well as the condition being treated.
- wings 511 a - b are not included and the ring 509 is molded, glued or otherwise affixed to the mesh so that, by itself, it couples the mesh strap 505 and the end region 120 c.
- the ring 509 of implant associator 510 can have varying thicknesses and/or varying lengths.
- FIG. 6 shows the delivery device 100 coupled with the mesh strap 505 of FIG. 5 .
- the end-region 120 c of the device 100 protrudes through the ring 509 even after the device 100 has been associated with the mesh strap 505 .
- This allows the delivery device 100 to dissect tissue as it implants the mesh strap 505 .
- the tip 130 of the device is pushed into the tissue and the associated ring 509 follows into the tissue.
- FIG. 7 shows the mesh strap 505 of FIGS. 5-6 , with an alternative implant associator 514 .
- the implant associator 514 includes a ring 513 that has circular cross-sections lying in a plane that is perpendicular to a plane of the mesh strap.
- the implant associator 514 is, in certain embodiments, used in operative combination with the delivery devices described herein.
- the alternative orientation of the ring 513 with respect to implant associator 514 in comparison to the ring 509 with respect to implant associator 510 results in a different orientation of the mesh strap 505 with respect to the delivery device 100 when the mesh strap 505 and the device 100 are coupled.
- This alternative orientation results in the strap 505 aligning with the end-region 120 c of the head 120 , as opposed to extending from the end-region 120 c of the head 120 at about a 90 degree angle as illustrated in FIG. 6 .
- the alternative orientation using implant associator 514 may be preferred by a medical operator when the operator is delivering the mesh strap 505 through a narrow anatomical incision and/or a narrow pathway through a patient's anatomy.
- FIG. 8 more particularly depicts the use of device 300 of FIG. 3 to implant a mesh strap 505 through a region 810 of the levator ani muscle 810 , more particularly, about the tendinous arch of the levator ani muscle or “white line” 805 .
- the operator associates the mesh strap 505 with the delivery device 300 using implant associator 510 .
- the operator then places the tip 330 of the delivery device 300 proximal to a target tissue region 810 .
- the operator rotates the device 300 counter clockwise along a longitudinal axis 311 of the shaft 305 of the device 300 , applying sufficient force to the shaft 305 to cause the tip 300 to dissect tissue and trace a path 811 below and around the tendinous arch 805 of the levator ani muscle.
- the tip 330 exits the tissue near a tissue region 812 , while the mesh strap 505 remains associated with the device 300 via implant associator 510 .
- the user then retracts the device 300 , leaving mesh strap 505 implanted in the levator ani muscle, by rotating the device 300 in a clockwise direction about the longitudinal axis 311 .
- the implant associator 510 dissassociates from the delivery device 300 when the back side 510 a of the implant associator 510 abuts against the tissue surface near tissue region 812 , thereby preventing the implant associator 510 from continuing in a retrograde direction along path 811 .
- the mesh strap 505 includes tanged edges or barbs to help anchor the strap in surrounding tissue proximal to the path 811 .
- the operator may use a tonged forceps instrument or other tong-like or tweezer-like instrument (not shown) to grasp and hold in place the implant associator 510 as the device 300 is retracted.
- the operator grasps the implant associator 510 with the forceps and pulls the implant associator 510 away from the tip 330 , thereby dissassociating the mesh strap 505 from the delivery device 300 , before retracting the delivery device 300 .
- the operator uses the forceps instrument to grasp the implant associator 510 and pull the implant associator 510 generally away from the tissue region 812 . This allows the operator to tension an implant, as discussed further below.
- the operator can use the device 400 of FIG. 4 to carry out the above procedure.
- the operator inserts the device 400 above the white line 805 using a clockwise rotation for insertion and a counterclockwise rotation for retraction.
- the insertion will be near tissue region 812
- the tip 430 will exit the tissue near region 810 .
- the devices described above include a head that is fixed to a shaft.
- the head and shaft are configured to rotate with respect to each other, thereby allowing the operator to adjust the placement of the head without moving the shaft.
- FIG. 9 shows such an exemplary alternative delivery device 900 including a shaft 905 with a distal end 905 a and a proximal end (not shown) opposite the distal end 905 a, and a head 920 , connected to the shaft 905 by pivotable junction 924 .
- the pivotable junction 924 allows the head 920 to rotate about the distal end 905 a of the shaft 905 , and in particular about an axis 925 in directions 930 and 932 without moving the shaft 905 .
- the axis 925 is perpendicular to the longitudinal axis 911 of the shaft 905 and normal to the plane of the rotatable head 920 .
- the pivotable junction 924 is adjustable to fix the position of the head 920 with respect to the shaft 905 at a desired position.
- the depicted junction 924 may include a hinge and pin assembly for fitting into a slot 927 about which the head 920 rotates.
- the hinge 924 and pin assembly can be configured to provide sufficient tightness such that the rotatable head 920 can be manually rotated to a desired position upon application of appropriate mechanical force to the head 920 , and then remain substantially fixed in that position upon insertion of the pin into the slot 927 .
- the pin can be released from the slot 927 to allow the head 920 to freely rotate about the shaft 905 , and then pushed fully into its slot 927 to fix the head 920 at a preferred orientation.
- the device 900 has a stop surface 926 that restricts the range of motion of the rotatable head 920 .
- a surface 920 a of rotatable head 920 aligns with the stop surface 926 , thereby preventing further rotation of the rotatable head 920 in the direction 930 .
- the stop surface 926 can be oriented at varying angles with respect to the longitudinal axis 911 in order to alter the angle beyond which rotation is prevented.
- the rotatable head feature allows an operator to adapt the configuration of the head 920 to facilitate insertion into various anatomical locations of a patient.
- the device 900 is configured to rotate about an axis 935 , which is tangential to the rotatable head 920 at region 920 b, where the head 920 meets the shaft 905 .
- This embodiment enables an operator to modify the orientation of the head 920 to be similar to the 90 degree angled configurations of the heads 320 and 420 in FIGS. 3-4 , or to be oriented with other preferred angles.
- rotation about the axis 935 is accomplished by inserting a pin in the shaft 911 , the pin's longitudinal axis being aligned with axis 935 , at location 905 c with a point of the needle extending in direction 933 .
- the junction 924 allows the device to rotate about any of axes 925 , 935 , and 911 independently or in combination.
- the hinge may include a ball-and-socket joint. Any of the devices described herein may be configured with a pivotable junction 924 .
- the shaft 905 and the head 920 of device 900 are substantially similar to the shaft 105 and the head 120 of the device 100 of FIG. 1 , and the various alternative embodiments and features of other delivery devices described herein may apply to device 900 .
- the device 900 can be used to secure one or more mesh straps of a surgical implant to a target tissue, for example the sacrospinous ligament or coccygeus muscle.
- a target tissue for example the sacrospinous ligament or coccygeus muscle.
- an operator first couples a mesh strap 505 (not shown in FIG. 9 ) to the device 900 using an implant associator 510 (not shown in FIG. 9 ) as described above.
- the operator positions the device 900 so that its tip 930 overlies a target region 940 a of the tissue 940 .
- the operator applies appropriate torque to the device 900 from its handle (not shown) and thereby drives the tip through the tissue 940 , as shown in FIG. 10 which depicts the head 920 partially disposed within the target tissue 940 .
- the operator may position a forefinger on the head 920 for leverage, thereby rotating the head 920 about the pivotable junction 924 and driving the head 920 into the tissue 940 without moving the shaft 905 .
- FIG. 11 shows the device 900 with its tip 930 associated with mesh strap 505 through implant associator 510 after having penetrated through the target tissue 940 .
- the operator drives the head 920 through the tissue 940 , such that the tip 930 , coupled with implant associator 510 , emerges through the tissue 940 .
- the operator then retracts the rotatable head 920 , leaving the mesh implanted through the tissue 940 and anchored by the implant associator 510 .
- an operator uses a forceps or other tong-like instrument to prevent the connector from retracting through the tissue 940 as discussed above.
- the mesh strap 505 may have tanged edges that help to anchor the strap in the ligament 940 .
- the delivery device 900 may, in one optional aspect, include a cannula 950 disposed about the shaft 905 .
- the cannula 950 is operably coupled to the rotatable pivot head 920 and is configured to control rotation of the head 920 .
- the cannula 950 includes a distal end 950 a that rotates the end of the pivot head 920 near or in contact with the junction 924 as desired by an operator.
- the operator may use external control mechanisms, such as knobs and/or buttons located near the handle (not shown) to rotate the head 920 .
- a Miya hook 990 may be modified and used to place one or more mesh straps of an implant.
- the Miya hook 990 includes a rounded head portion 992 , a shaft 994 , and scissor-like handles 996 .
- the rounded head portion 992 and the shaft 994 are configured to rotate with respect to each other, thereby allowing the operator to adjust the placement of the head portion 992 without moving the shaft.
- the head portion 992 includes a shoulder 993 , such that the tip of the head portion 992 may associate with an associator, such as implant associator 510 of FIG. 5 .
- FIG. 13A depicts an inferior view of a pelvic floor implant 960 positioned within a patient by the use of one or more of the devices described herein.
- the implant 960 includes a central region 964 and a plurality of straps 962 a - 962 f similar to mesh strap 505 .
- the straps 962 a - 962 f include two anterior straps 962 a and 962 b, and four posterior straps, 962 c and 962 e on one side, and 962 d and 962 f on the contra-lateral side.
- an implant 960 includes 6 straps, more or fewer straps may be used depending on the nature of the condition being treated, and exemplary embodiments include 2, 3, 4, or 5 straps. For example, if a medical operator determines that a patient requires posterior support but not anterior support, an implant may consist of four straps 962 c - 962 f, but not straps 962 a - 962 b.
- the mesh implant 960 is sized and shaped to fit on or near the pelvic floor and support the bladder, the vagina, and/or the rectum.
- the straps 962 a - 962 f are spaced apart so as to align with particular anatomical locations within the pelvic region for securing the implant 960 thereto.
- the anterior straps 962 a and 962 b are positioned to align with the patient's obturator foramen (not shown, but generally located at regions 976 a and 976 b ) and optionally can ultimately be pushed through the patient's obturator membranes.
- Posterior straps 962 c and 962 d are positioned to align with the tendinous arch of the levator ani muscle 973 , only a portion of which is depicted in FIG. 13A
- posterior straps 962 e and 962 f are positioned to align with the sacrospinous ligament 975 , only a portion of which is depicted in FIG. 12 .
- the posterior straps 962 c and 962 d are placed in the iliococcygeus muscle.
- the posterior straps 962 e and 962 f may be positioned in the sacrospinous ligament and the coccygeus muscle, or alternatively, only in the coccygeus muscle.
- the mesh straps 962 a - 962 f may include respective implant associators (not shown), similar to implant associator 510 .
- the devices and systems described herein may be used in surgical procedures to treat a patient suffering from pelvic floor disorders or urinary incontinence.
- An exemplary technique for implanting and securing the surgical mesh 960 in an anatomy of a patient is now described.
- the exemplary technique consists of three phases.
- a first phase the operator inserts and secures the posterior straps 960 e and 960 f into the sacrospinous ligament, the coccygeus muscle, or both the sacrospinous ligament and coccygeus muscle.
- the operator inserts and secures the posterior straps 962 c and 962 d into the levator ani muscle, for example, the tendinous arch of the levator ani muscle or the iliococcygeus muscle.
- the operator inserts the anterior straps 962 a and 962 b through the obturator foramen and secures the straps in either obturator membranes or in the patient's tissues proximal to the obturator canals.
- a medical operator creates an incision in a patient's anterior vaginal wall (not shown).
- the incision can be dissected or extended as required to facilitate access of delivery device 100 to target region 974 e.
- the operator couples, preferably external to the body, mesh strap 962 e with delivery device 100 via an implant associator (not shown) similar to implant associator 510 .
- the operator then inserts the device 100 and coupled mesh strap 962 e through the vaginal opening 972 , into the vaginal canal, and through the vaginal incision.
- the operator pierces and drives the mesh strap 962 e through the target region 974 e of the sacrospinous ligament, and then retracts the device, using methods similar to those described above. As mentioned above, the operator may use forceps to facilitate the disassociation of the delivery device 100 from the mesh strap 962 e.
- the operator then delivers the mesh strap 962 f through the vaginal opening 972 and through the vaginal incision in a similar manner as 962 e.
- the vaginal incision may be dissected or extended as necessary to facilitate access of delivery device 100 to target region 974 f.
- the operator may use the same delivery device 100 for delivery of strap 962 f, or alternatively may use a second delivery device 100 .
- the first phase can also be carried out using delivery device 900 of FIG. 9 or delivery device 101 of FIG. 1B instead of delivery device 100 .
- delivery device 900 is beneficial in part because the operator can adjust the rotation of the rotatable head 920 to suit the operator's preference and/or the particular anatomy of the patient.
- delivery device 101 is beneficial in part because its curved shaft 103 may facilitate passage of the device through the vaginal canal in order to access the target regions 974 e and 974 f of the sacrospinous ligament.
- the operator inserts the straps 962 c and 962 d into target regions 974 c and 974 d of the levator ani muscle.
- the operator first couples delivery device 300 to the mesh strap 962 c using an implant associator (not shown), then inserts the device 300 into the vaginal canal, and through the vaginal incision.
- the vaginal incision provides access to the target region 974 c in part because the head 320 of the device 300 is rotated so its tip 330 aligns with the target region 974 c.
- the operator can choose a device 900 and adjust the rotation of rotatable head 920 to align the tip 930 with target region 974 c.
- the operator With the device 300 appropriately placed proximal to the target tissue region 974 c, the operator then pierces and drives the mesh strap 962 c through the target region 974 c of the levator ani muscle, and retracts the delivery device 300 using the method discussed with respect to FIG. 8 .
- the operator similarly delivers mesh strap 962 d to target region 974 d of the tendinous arch of the levator ani muscle contra-lateral to target region 974 c using delivery device 400 . Similar to delivery device 300 accessing target region 974 c, device 400 accesses target region 974 d through the vaginal incision used to deliver strap 962 f. Alternatively, the operator can choose a device 900 and adjust the rotation of rotatable head 920 to align the tip 930 with target region 974 d.
- the operator inserts the anterior straps 962 a and 962 b through the obturator foramen and secures the straps either to respective obturator membranes or to the patient's tissues proximal the obturator canals as discussed in, for example, U.S. patent application Ser. No. 10/957926, the entire contents of which are incorporated by reference herein in their entirety.
- an operator implants the anterior strips 962 a and 962 b using delivery devices that create passages through body tissue from an inferior pubic ramus through an obturator foramen to a location proximal the vaginal opening 972 .
- the operator creates such a passage on each side of the patient.
- the delivery devices may include needles and/or dilators having curved portions that can trace paths through an obturator foramen located generally at 976 a or 976 b, through the vaginal incision in the anterior vaginal wall, and ultimately to a region externally accessible via vaginal opening 972 .
- FIG. 15A shows a delivery device 983 that can deliver anterior strap 962 a
- FIG. 15B shows a delivery device 984 that can deliver anterior strap 962 b
- device 985 depicted in various perspectives in FIGS. 16A , 16 B, and 16 C, can deliver anterior strap 962 b, while a symmetric device can deliver anterior strap 962 a.
- the anterior straps In one implementation of the anterior straps, two incisions are made on the body of the patient. A first incision is made just to the side of the edge of the ishiopubic ramus in the region of the urethral meatus. A second incision, corresponding to the first incision, is made on the contra-lateral side.
- the strap 962 a is associated with the delivery device 983 of FIG. 15A , which is inserted through the vaginal incision toward the obturator foramen.
- the delivery device 983 pierces the obturator membrane, and the tip of the delivery device 983 along with the end of the strap 962 a exits the patient tissue through the first incision.
- the operator delivers and secures strap 962 b by repeating this process symmetrically with delivery device 984 on the contra-lateral side of the body.
- the operator extends the delivery device 983 to an anatomical position in front of the obturator membrane without piercing the membrane.
- the strap 962 a is configured with soft tissue anchor end portions for anchoring into the soft tissue in front of the membrane.
- Sling assemblies with soft tissue anchors and devices and methods for applying slings with soft tissue anchors are disclosed, for example, in commonly assigned U.S. patent application Ser. No. 11/400111, filed Apr. 6, 2006 and entitled “Systems, Devices and Methods for Treating Pelvic Floor Disorders,” U.S. patent application Ser. No. 11/399913, filed Apr. 6, 2006 and entitled “Systems, Devices and Methods for Suburethral Support,” and U.S. patent application Ser. No. 11/152898, filed Jun. 14, 2005 and entitled “Systems, Methods and Devices Relating to Implantable Supportive Slings,” the contents of each of which are incorporated by reference herein in their entirety.
- the delivery device 983 of FIG. 15A is inserted through one ishiopubic incision, piercing the obturator muscle and obturator membrane.
- a forefinger is placed in the vaginal incision and on the distal end of the delivery device. The forefinger is used to guide the distal end of delivery device 983 around the ishiopubic ramus through the vaginal incision.
- the operator associates strap 962 a with the delivery device 983 .
- the delivery device 983 and the mesh strap 962 a can be associated with any of the implant associators discussed herein, or the implant association techniques discussed in U.S. patent application Ser. No. 10/542365.
- the delivery device 983 may include an L-slot near the distal tip, which may be used to associate the mesh strap 962 a with the delivery device 983 , such that the delivery device can pull the mesh strap 962 a back out through the ischiopubic incision.
- the delivery device 983 is then withdrawn from the ischiopubic incision, drawing the end of the mesh strap 962 a through the passage created by the delivery device 983 . Finally, the operator delivers and secures strap 962 b by repeating this process symmetrically with delivery device 984 on the contra-lateral side of the body.
- FIG. 13B shows a lateral view of the pelvic region of the patient, and more particularly shows the device 100 aligned with the sacrospinous ligament 975 , and the device 300 aligned with the tendinous arch of the levator ani muscle 973 , of which only a portion is shown.
- the implant 960 is not shown.
- the straps and incisions need not be inserted or made, respectively, in the order described above.
- An operator can choose any suitable order for creating incisions and delivering straps 962 a - 962 f.
- the operator at his discretion, optionally performs one or more cystoscopies after inserting one or more of the mesh straps 962 a - 962 f to check for damage to the bladder.
- the anterior straps 962 a - 962 b may be cut off or otherwise removed from the implant 960 .
- the anterior straps 962 a - 962 b may be removed from the implant 960 before implantation.
- the central region 964 of the implant 960 may be sutured or otherwise attached to the pubococcygeus muscle and/or the anterior portion of the tendinous arch of the levator ani muscle.
- the exemplary three phase technique described above employed various ones of the delivery devices 100 , 101 , 300 , 400 , 983 , 984 , 985 , and/or 900 to delivery various ones of the straps 962 a - 962 f.
- Each of these devices can be provided with a handle 119 shown in FIG. 8 that is color-coded to match the color of the implant associator corresponding to the mesh strap 962 a - 962 f that the device delivers.
- the operator can thereby visually identify which of the devices 100 , 101 , 300 , 400 , 983 , 984 , 985 , and/or 900 will deliver which of the straps 962 a - 962 f.
- the device 100 may include a handle 119 with multiple color codes. Other visual indications or markers may also be used.
- Implant 960 Other delivery methods can be used for implant 960 .
- suprapubic, prepubic, and transvaginal approaches disclosed in the patents and patent applications cited herein, can be used to delivery one or more of the straps 962 a - 962 f. All operative combinations between the disclosed delivery devices and these alternative procedures are contemplated. Any of the delivery devices described above may be employed to create appropriate passageways to target regions in a patient's anatomy.
- the operator adjusts the tension of the implant 960 by pulling the mesh straps 962 a - 962 f further through their respective target tissue regions.
- an operator inserts a forceps through one of the vaginal incisions to one of the target regions 962 a - 962 f.
- the operator may grasp and pull a respective implant associator (not shown) and thereby pull the respective mesh strap 962 a - 962 f further through its tissue or ligament, as described above. This increases the tension of the implant.
- the operator may perform this process for one or more of the mesh straps until the desired tension is achieved.
- the mesh straps such as mesh straps 962 a - 962 f, are not driven through muscle or ligament, but instead are anchored into general surrounding tissue by barbs or tangs on the edges and/or surfaces of the implant 960 and/or its straps 962 a - 962 f.
- the straps 962 a - 962 f can alternately be secured to soft tissue regions of the pelvic floor using soft tissue anchors as discussed in U.S. Provisional Application No. 60/715362, the contents of which are incorporated herein by reference in their entirety.
- one or more of the straps 962 a - 962 f may be secured to target tissue regions by suturing the straps.
- straps 962 c - f can be sutured to target tissue regions of the levator ani muscle and/or the sacrospinous ligament.
- the invention includes a kit with devices for use in supporting or repairing pelvic floor problems.
- FIG. 14 illustrates an exemplary surgical kit 980 for use in surgery related to pelvic floor repair.
- the kit 980 includes these devices—device 100 , device 300 , and device 400 .
- the shafts 305 and 405 are about equal in length and shaft 105 is between about 15% and 60% longer than shafts 305 and 405 . In certain embodiments, shaft 105 is about 20% longer than shafts 305 and 405 .
- the kit also includes one or more surgical implants, such as the implant 960 .
- the straps 962 a - 962 f are coupled with respective implant associators similar to implant associator 510 , however in alternate embodiments the implant associators can be provided in the kit separate from the straps 962 a - 962 f or may not be provided at all.
- the kit 980 includes one or more of the devices 983 and 984 of FIG. 15A and FIG. 15B . Additionally or alternatively, the kit 980 may include one or more of device 985 of FIGS. 16A-16C , as well as a symmetric device for use on a contra-lateral side of a patient. The kit 980 may additionally or alternatively include one or more of the delivery devices discussed in U.S. patent application Ser. No. 10/957926 and/or device 101 of FIG. 1B . In alternative embodiments, device 900 is provided with (or without) one or more of the devices included in kit 980 .
- FIGS. 15A and 15B depict a pair of delivery devices 983 and 984 , each having an angled handle, according to another illustrative embodiment of the invention.
- the devices 983 and 984 are substantially mirror images of each other for ease of use on either side of a patients body. Accordingly, for illustrative purposes, only FIG. 12A is discussed.
- the handle 987 of the delivery device 983 includes a first section 987 a extending along a first longitudinal axis substantially in a first plane.
- a second section 987 b of the handle 987 extends distally from, but at an angle to, the axis of the first section 987 a.
- the first 987 a and second 987 b sections of the handle 987 are substantially coplanar in the first plane.
- a shaft 989 includes a curved section that extends from a mounting location at a distal end of the second handle section 987 b.
- the curved section first extends out of the first plane of the first 987 a and second 987 b handle sections, then extends back toward the first plane.
- the distal tip 989 a (conically shaped in the illustrative embodiment) of the delivery device 983 extends back through the first plane.
- the distal tip 989 a extends up to or short of the first plane.
- the shaft 989 rotates about an axis that is substantially orthogonal to the first plane.
- the axis need not be substantially orthogonal to the first plane.
- at least one of the first 987 a and second 987 b sections of the handle 987 tapers to have a narrower width as the handle 987 extends distally toward the shaft.
- FIGS. 16A-16C depict various views of a delivery device 985 having a handle 991 with first 991 a and second 991 c substantially straight sections located substantially in a first plane and angled relative to each other at 991 b, a transitional portion 993 extending out of a distal end of the handle 991 , and a shaft 995 extending from a distal end of the transitional portion 993 .
- the shaft includes curved section 995 a, a straight section 995 b, and terminates in a conical tip 995 c.
- the transitional portion 993 interfits and extends axially out of the distal end of the second handle section 991 c to affix the shaft 995 to the handle 991 .
- the transitional portion 993 is substantially co-planar with the handle 991 in the first plane.
- the curved section 995 a of the shaft 995 extends from a distal end of the transitional portion 993 .
- the straight section 995 b of the shaft 995 extends from a distal end of the curved section 995 a.
- the curved section 995 a and the straight section 995 b are substantially coplanar in a second plane. According to the illustrative embodiment of FIGS.
- the first and second planes are substantially orthogonal to each other.
- the first and second planes may be at any suitable angle (e.g., about 10, 20, 30, 45, 60, 70 or 80 degrees) to each other.
- the first and second sections 991 a and 991 c of the handle 991 are at an angle of about 150 degrees to each other.
- first and second sections 991 a and 991 c of the handle 991 may be at any suitable angle (e.g., about 80, 90, 100, 110, 120, 130, 140, 160, 170 or 180 degrees) to each other.
- sections 991 b and 991 c have a cross sectional diameter that tapers to be smaller at the distal end 143 of the handle 991 .
- the tapered portions 991 a, 991 b, and 991 c of the embodiment of FIG. 16 are formed as part of the handle 991 .
- this configuration reduces the length of the transitional portion 993 and thus, provides improved structural support for the curved section 995 a.
- neither the handle 991 nor the transitional portion 993 extends into the body of the patient, and the angle at transitional portion 993 provides a positive stop against this occurring.
- the surgical implants of this invention are typically a mesh material.
- the sling may, in the alternative or in combination, be made of other types of materials.
- Exemplary mesh materials include, for example, synthetic materials, natural materials (e.g., biological) or a combination thereof.
- the mesh may be fabricated from any of a number of biocompatible materials, such as nylon, silicone, polyethylene, polyester, polyethylene, polyimide, polyurethane, polypropylene, fluoropolymers, copolymers thereof, combinations thereof, or other suitable synthetic material(s).
- the material may be, for example, a biodegradable synthetic material.
- biodegradable refers to the property of a material that dissolves in the body. Such materials may also be absorbed into the body, i.e., bioabsorbable.
- Suitable bioabsorbable synthetic materials include, without limitation, polylactic acid (PLA), polyglycolic acid (PGA), poly-L-lactic acid (PLLA), poly(amino acids), polypeptides, human dermis and decellularized animal tissue.
- Human tissues may be derived, for example, from human cadaveric or engineered human tissue.
- Animal tissues may be derived, for example, from porcine, ovine, bovine, and equine tissue sources.
- the material may be an omnidirectional material, a material that has equivalent tensile strength from any direction, such as pericardium or dermis.
- the material may be an oriented material, a material that has a single direction where the tensile strength of the material is the highest.
- Oriented materials may include rectus fascia and/or facia lata, as well as oriented synthetic materials.
- Exemplary biodegradable polymers which may be used to form the tubular mesh 100 , in addition to those listed above, include, without limitation, polylactic acid, polyglycolic acid and copolymers and mixtures thereof, such as poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), polyglycolic acid [polyglycolide (PGA)], poly(L-lactide-co-D,L-lactide) (PLLA/PLA), poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D,L-lactide-co-glycolide) (PLA/PGA), poly(glycolide-co-trimethylene carbonate) (PGA/PTMC), poly(D,L-lactide-co-caprolactone) (PLA/PCL), and poly(glycolide-co-caprolactone) (PGA/PCL); polyethylene oxide (PEO); polydioxanone (PDS); polypropy
- the implant 960 may include an agent for release into the patient's tissues.
- One illustrative agent is a tissue growth factor that promotes, when applied to the patient's tissues in a pharmaceutically acceptable amount, well-organized collagenous tissue growth, such as scar tissue growth, preferably, in large quantities.
- the agent may or may not block or delay the dissolvability of the biodegradable materials. This may be controlled by selecting differing methods for loading the agent onto the sling.
- the tissue growth factor may include natural and/or recombinant proteins for stimulating a tissue response so that collagenous tissue such as scar tissue growth is enhanced.
- Exemplary growth factors include, but are not limited to, platelet-derived growth factor (PDGF), fibroblast growth factor (FGF), transforming growth factor-beta (TGF-beta), vascular endothelium growth factor (VEGF), Activin/TGF and sex steroid, bone marrow growth factor, growth hormone, Insulin-like growth factor 1, and combinations thereof.
- the agent may also include a hormone, including but not limited to estrogen, steroid hormones, and other hormones to promote growth of appropriate collagenous tissue such as scar tissue.
- the agent may also include stem cells or other suitable cells derived from the host patient. These cells may be fibroblast, myoblast, or other progenitor cells to mature into appropriate tissues.
- passive agents may be applied to promote tissue ingrowth. For example, titanium sputtering or chrome sputtering can be used.
- the agent may include one or more therapeutic agents.
- the therapeutic agents may be, for example, anti-inflammatory agents, including steroidal and non-steroidal anti-inflammatory agents, analgesic agents, including narcotic and non-narcotic analgesics, local anesthetic agents, antispasmodic agents, growth factors, gene-based therapeutic agents, and combinations thereof.
- Exemplary steroidal anti-inflammatory therapeutic agents include, but are not limited to, 21-acetoxyprefnenolone, aalclometasone, algestone, amicinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumehtasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, flu
- non-steroidal anti-inflammatory therapeutic agents include, but are not limited to, aminoarylcarboxylic acid derivatives such as enfenamic acid, etofenamate, flufenamic acid, isonixin, meclofenamic acid, mefanamic acid, niflumic acid, talniflumate, terofenamate and tolfenamic acid; arylacetic acid derivatives such as acemetacin, alclofenac, amfenac, bufexamac, cinmetacin, clopirac, diclofenac sodium, etodolac, felbinac, fenclofenac, fenclorac, fenclozic acid, fentiazac, glucametacin, ibufenac, indomethacin, isofezolac, isoxepac, lonazolac, metiazinic acid, oxametacine, proglumetacin,
- Exemplary narcotic analgesic therapeutic agents include, but are not limited to, alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, codeine methyl bromide, codeine phosphate, codeine sulfate, desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, hydrocodone, hydromorphone, hydroxy
- non-narcotic analgesic agents that may be combined with the slings of the invention include, but are not limited to, aceclofenac, acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid, alclofenac, alminoprofen, aloxiprin, aluminum bis(acetylsalicylate), aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine, ammonium salicylate, amtolmetin guacil, antipyrine, antipyrine salicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen, benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide, 5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin
- Exemplary local anesthetic therapeutic agents include, but are not limited to, ambucaine, amolanone, amylocaine hydrochloride, benoxinate, benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, butaben, butanilicaine, butethamine, butoxycaine, carticaine, chloroprocaine hydrochloride, cocaethylene, cocaine, cyclomethycaine, dibucaine hydrochloride, dimethisoquin, dimethocaine, diperadon hydrochloride, dyclonine, ecgonidine, ecgonine, ethyl chloride, beta-eucaine, euprocin, fenalcomine, fomocaine, hexylcaine hydrochloride, hydroxytetracaine, isobutyl p-aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine, mepi
- antispasmodic therapeutic agents include, but are not limited to, alibendol, ambucetamide, aminopromazine, apoatropine, bevonium methyl sulfate, bietamiverine, butaverine, butropium bromide, n-butylscopolammonium bromide, caroverine, cimetropium bromide, cinnamedrine, clebopride, coniine hydrobromide, coniine hydrochloride, cyclonium iodide, difemerine, diisopromine, dioxaphetyl butyrate, diponium bromide, drofenine, emepronium bromide, ethaverine, feclemine, fenalamide, fenoverine, fenpiprane, fenpiverinium bromide, fentonium bromide, flavoxate, flopropione, gluc
- the implants, such as implant 800 , of the invention may include any suitable end portions, such as tissue dilators, anchors, and association mechanisms for associating the sling with the delivery devices of the invention. They may also include other slings, sling assemblies, sling delivery approaches, sling assembly-to-delivery device association mechanisms, and sling anchoring mechanisms.
- tissue dilators such as tissue dilators
- anchors such as anchors
- association mechanisms for associating the sling with the delivery devices of the invention. They may also include other slings, sling assemblies, sling delivery approaches, sling assembly-to-delivery device association mechanisms, and sling anchoring mechanisms.
Abstract
Description
- This application claims the benefit of U.S. Provisional Application Ser. No. 60/849,199, filed Oct. 3, 2006 and titled “Systems, Devices and Methods for Treating Pelvic Floor Disorders,” the entire contents of which are incorporated herein by reference.
- Pelvic floor disorders afflict many women. According to some studies, about 1 out of 11 women needs surgery for a pelvic floor disorder during her lifetime. The pelvic floor generally includes muscles, ligaments, and tissues that collectively act to support anatomical structures of the pelvic region, including the uterus, the rectum, the bladder, and the vagina. Pelvic floor disorders include vaginal prolapse, vaginal hernia, cystocele, rectocele, and enterocele. Such disorders are characterized in that the muscles, ligaments and/or tissues are damaged, stretched, or otherwise weakened, which causes the pelvic anatomical structures to fall or shift and protrude into each other or other anatomical structures.
- Moreover, pelvic floor disorders often cause or exacerbate female urinary incontinence (UI). One type of UI, called stress urinary incontinence (SUI), affects primarily women and is generally caused by two conditions-intrinsic sphincter deficiency (ISD) and hypernobility. These conditions may occur independently or in combination. In ISD, the urinary sphincter valve, located within the urethra, fails to close (or “coapt”) properly, causing urine to leak out of the urethra during stressful activity. In hypermobility, the pelvic floor is distended, weakened, or damaged, resulting in increases in intra-abdominal pressure (e.g., due to sneezing, coughing, straining, etc.) and consequently the bladder neck and proximal urethra rotate and descend. As a result, the urethra does not close with sufficient response time, and urine leaks through the urethra.
- UI and pelvic floor disorders, which are usually accompanied by significant pain and discomfort, are typically treated by implanting a supportive sling in or near the pelvic floor region to support the fallen or shifted anatomical structures or to, more generally, strengthen the pelvic region by, for example, promoting tissue ingrowth. Often, treatments of stress incontinence are made without treating the pelvic floor disorders at all, potentially leading to an early recurrence of the pelvic floor disorder.
- Existing devices, methods, and kits for treatment typically apply delivery devices to position a supportive sling into a desired position in the pelvic region. However, these devices may be difficult for a surgeon to manipulate within the posterior pelvic region without adversely affecting surrounding anatomical structures during the delivery process. Moreover, when treating pelvic floor disorders and UI it is desirable to anchor the sling to a plurality of locations in the pelvic region, but most commonly available surgical kits do not provide devices that are suitably sized and/or shaped. Thus, surgeons have limited ability to access different locations in the pelvic region. Accordingly, medical operators and patients need improved systems, methods, and surgical kits for the treatment of pelvic floor disorders and/or urinary incontinence.
- The invention generally pertains to devices, systems, and methods to deliver surgical implants within patients. The devices include delivery devices which can be used to implant a supportive mesh in the pelvic region of a patient for pelvic floor repair and/or for treatment of urinary incontinence. The devices also include surgical implants that are sized, shaped, and constructed to support various organs within the pelvic region of a patient, or more generally to promote tissue growth within and generally stabilize the pelvic region.
- In one aspect, the invention includes a delivery device for delivering an implantable sling to an anatomical location within a patient. The devise includes a shaft having a distal end and a proximal end, a head having a curved region, a tip disposed at a distal end of the curved region, and a substantially linear region at a proximal end of the curved region, and a curved junction connecting the proximal end of the curved region and the distal end of the shaft, wherein an axis of the substantially linear region is perpendicular to a longitudinal axis of the shaft.
- In another implementation, the delivery device includes a shaft having a distal end and a proximal end, a rotatable head distal to the shaft including a tip at a distal end of the head, and a pivotable junction connecting the head and the shaft. The rotatable head may include a curved region. In one feature, the rotatable head is rotatable about the distal end of the shaft. The curved regions may be semi-circular.
- In one configuration, the tips employed with the device are equiplanar with the longitudinal axis of the shaft portion. In another configuration, the head lies in a plane, and the longitudinal axis of the shaft portion is normal to the plane. For example, the head may extend in a counterclockwise path from the distal end of the shaft, or the head may extend in a clockwise path from the distal end of the shaft. In other configurations, the head lies in a plane, and the longitudinal axis of the shaft has a non-normal incidence with the plane. The device may be used to implant a sling within a patient. The device may include other components such as stopping mechanisms, implant associators, and soft tissue anchors adapted to aid the implantation of the sling.
- In another aspect, the invention includes methods for delivering to a patient an implant having a central region and at least four extension/appendage regions. The methods include securing a first extension of the implant to at least one of a sacrospinous ligament, a coccygeus muscle, an ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani muscle on a first side of a patient, securing a second extension of the implant to at least one of a sacrospinous ligament, a coccygeus muscle, an ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani muscle on a contra-lateral side of the patient, delivering a third extension of the implant through an obturator foramen on the first side of the patient, and delivering a fourth extension of the implant through an obturator foramen on the contra-lateral side of the patient.
- In one implementation, the methods include securing the first extension with a first delivery device, securing the second extension with a second delivery device different from the first delivery device, and delivering the third extension with a third delivery device different from the first delivery device and different from the second delivery device.
- The methods may also include securing a fifth extension to at least one of a sacrospinous ligament, a coccygeus muscle, an ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani muscle on the first side of a patient, and securing a sixth extension to at least one of a sacrospinous ligament, a coccygeus muscle, an ischiococcygeus muscle, an iliococcygeus muscle, and a levator ani muscle on the contra-lateral side of the patient. In one implementation, the methods contemplate the use of a plurality of devices having different lengths. In one configuration, the methods include securing a fifth extension with a delivery device different from the first delivery device, different from the second delivery device, and different from the third delivery device.
- In one feature, the methods include associating the respective first or second extension with a delivery device including a head, the head portion including a tip, and driving the tip of the delivery device through the respective sacrospinous ligament, coccygeus muscle, or levator ani muscle. This may include placing the tip against the respective sacrospinous ligament, coccygeus muscle, or levator ani muscle, and applying pressure directly on the head. In one feature, at least one of securing the first extension and securing the second extension may include suturing the respective first or second extension to the respective sacrospinous ligament, coccygeus muscle, or levator ani muscle.
- In an additional aspect, the invention includes a surgical kit having one or more of the devices described herein for use in delivering an implant within a patient. In certain embodiments the kit includes a first delivery device having a first shaft for delivering a first implant region, and a second delivery device having a second shaft for delivering a second implant region. The kit may include a third delivery device having a third shaft for delivering a third implant region. In certain embodiments, the shafts are provided with differing lengths.
- In one configuration, one shaft is more than about 20% longer than one or more other shafts in the kit. The kit may also include an implant, and optionally, other devices for assisting in the exemplary surgical procedures. Methods for associating the delivery devices with the implants, methods for delivering the implants to desired locations within a patient, and methods for positioning, tensioning, and/or fixating the implants within a patient are also contemplated. Exemplary applications of the devices and methods include the treatment of conditions such as prolapse, vaginal hernia, cystocele, rectocele, enterocele, and urinary incontinence. These and other aspects will be described herein.
- These and other features and advantages of the invention will be more fully understood by the following illustrative description with reference to the appended drawings, in which like elements are labeled with like reference designations and which may not be to scale.
-
FIG. 1A shows a delivery device for delivering a pelvic floor implant to an anatomical location. -
FIG. 1B illustrates another embodiment of a delivery device for delivering a pelvic floor implant to an anatomical location. -
FIGS. 2A-2B show close-up views of the head portions of an exemplary pelvic floor delivery device. -
FIG. 3 shows an alternative embodiment of an exemplary pelvic floor delivery device having a head oriented perpendicularly to a shaft. -
FIG. 4 shows an alternative configuration of the device ofFIG. 3 having a head oriented on a contra-lateral side of the shaft. -
FIG. 5 shows an exemplary pelvic floor device and an implantable mesh strap assembly including an implant associator. -
FIG. 6 shows the delivery device ofFIG. 5 coupled with the mesh strap ofFIG. 5 . -
FIG. 7 shows the mesh strap ofFIG. 5 , with an alternative implant associator. -
FIG. 8 illustrates the use of an exemplary pelvic floor device in implanting a mesh strap into tissue. -
FIG. 9 shows an alternative embodiment of a pelvic floor delivery device having a rotatable head. -
FIG. 10 illustrates the use of the device ofFIG. 9 in penetrating tissue. -
FIG. 11 shows the device ofFIG. 9 in association with a mesh strap implant associator and penetrating through a target ligament. -
FIG. 12 shows a Miya device which may be used to place one or more mesh straps of an implant. -
FIG. 13A illustrates an inferior view of a sling implanted within a patient using a device according to the invention. -
FIG. 13B illustrates a lateral view of the sling implant illustrated inFIG. 13A . -
FIG. 14 illustrates a surgical kit for use in pelvic floor repair. -
FIGS. 15A-15B show delivery devices for delivering an anterior implant strap. -
FIGS. 16A-16C show various views of a delivery device for delivering anterior implant straps. - The devices, methods, and kits of this invention are generally used to deliver a surgical implant, such as an implantable sling, to the pelvic region of a patient for pelvic floor repair and/or for treatment of urinary incontinence. The devices include improved delivery tools that are sized and shaped to deliver the surgical implant to the pelvic region, and improved surgical implants sized, shaped, and constructed to support various organs within the pelvic region, or more generally to promote tissue growth in and the general stability of the pelvic region. In certain embodiments, the implant includes a central region and a plurality of extensions, such as mesh straps, that extend from the central region and are anchored at respective locations in the pelvic region of a patient to appropriately position and/or tension the implant. The extensions are anchored to the patient's pelvic floor using delivery devices that drive the extensions through the tissues, ligaments, and/or muscle regions thereof.
- The devices may be configured to allow the operator to deliver and secure the implant to posterior regions of the pelvic floor, such as the sacrospinous ligament, the coccygeus muscle, the ischiococcygeus muscle, the iliococcygeus mscule, and the tendinous arch of the levator ani muscle. Such anatomical locations are useful locations for anchoring the straps of pelvic floor implants within the pelvic region. An operator accesses these anatomical locations by guiding the devices through a vaginal incision.
- Methods for associating the delivery devices with the implants, methods for delivering the implants to desired locations within a patient, and methods for positioning, tensioning, and/or fixating the implants within a patient are described.
- The delivery devices used to implant the various extension need not be the same, and in one implementation, a surgical kit including three delivery devices is provided. In such implementations, each of these devices are sized and shaped to facilitate delivery to certain ones of the tissue regions.
-
FIG. 1A depicts an exemplary embodiment of adevice 100 that is adapted to deliver, through a vaginal incision, a mesh strap to a target tissue region of the sacrospinous ligament. The sacrospinous ligament is a thin and triangular tissue that is attached by its apex to the spine of the patient's ischium, and medially, by its broad base, to the lateral margins of the sacrum and coccyx in front of the sacrotuberous ligament. The sacrospinous ligament is a convenient location to anchor mesh straps in the posterior regions of the pelvic floor in order to provide posterior support. - The
device 100 may also be adapted to deliver, through a vaginal incision, a mesh strap to a target tissue region of the coccygeus (or ischiococcygeus) muscle. The coccygeus muscle is a triangular muscle that originates from the ischial spine and the sacrospinous ligament and the coccyx, and inserts on the lateral aspects of the lower sacrum and the upper coccyx. - The
delivery device 100 includes ashaft 105, ahandle 122, ahead 120 for attaching to an implant and delivering the implant to the patient's anatomy, and acurved junction 124 configured within an arc that allows thehead 120 to penetrate the patient's anatomy. Theshaft 105 includes adistal end 105 a, aproximal end 105 b, and alongitudinal axis 111. Theshaft 105 has alength 107 that is substantially longer than thelength 108 of thehead 120. The relativelylong shaft length 107 allows an operator to insert the device through the vaginal cavity of a patient and place thehead 120 within the posterior pelvic region in proximity to the sacrospinous ligament or the coccygeus muscle. - The
shaft 105 is shown to be substantially linear, but it may be slightly curved to form either a convex or a concave arc to further facilitate delivery of the head .FIG. 1B illustrates analternate embodiment 101 of thedelivery device 100 ofFIG. 1A having acurved shaft 103 instead of thelinear shaft 105 ofFIG. 1A . Thecurved shaft 103 may facilitate passage of the device through the vaginal canal to access the sacrospinous ligament or coccygeus muscle of the patient. In addition, the curved shaft allows rotation of thedelivery device 101 for insertion of thehead 120 into the patient's tissues. This may be done, for example, by applying a force indirection 140 to theproximal end 103 b of thedevice 101 thereby rotating the device about themiddle area 103 c of theshaft 103 such that thedistal end 103 a of theshaft 103 and thehead 120 rotate into the tissues in thedirection 141. The amount of curvature will typically be chosen to facilitate delivery of the device into the patient using a preferred method and path of insertion, described in exemplary embodiments below. - Referring again to
FIG. 1A , theshaft 105 also has acircular cross-section 113 with a radius selected as needed to suit an intended path and location for delivery of the implant. In certain embodiments, the radius is about 0.05 inches, about 0.0625 inches, or about 0.075 inches which allows thedevice 100 to be inserted through a vaginal incision and into the sacrospinous ligament or coccygeus muscle, as described more particularly in connection withFIGS. 13A-13B . In certain embodiments, the radius is about 0.5 inches or less. In certain embodiments, the radius is about 0.125 inches. In certain embodiments, the radius is between about 0.01 inches and about 0.5 inches, or as otherwise desired to aid in implantation within other pelvic floor areas. - As noted, the device includes a
handle 122 that is configured to allow an operator to grasp and manipulate the device as required to deliver a surgical implant to a desired location in a patient's anatomy. - The
handle 122 is generally a looped region of theshaft 105 at theproximal end 105 b of theshaft 105. However, the depictedhandle 122 is not intended to be limiting and other suitable handle configurations can be used. By way of example, thedevice 100 can include thehandle 119 of thedevice 300 illustrated inFIG. 8 . Thehandle 119 is sized and shaped to be comfortably grasped and manipulated by an operator. The handle can be made of a single material, or a combination of materials. Exemplary materials include acrylonitrile butadiene styrene and soft durometer TPE. Other suitable materials may be used, including thermoplastic materials and other materials suitable for surgical environments. - As noted, the
device 100 includes ahead 120 that is configured to enable an operator to deliver and secure an implant to a desired anatomical structure in the body, such as a region of the sacrospinous ligament, coccygeus muscle, or other positions within the pelvic region. More particularly, thehead 120 includes acurved region 120 a, a substantiallylinear region 120 b at a proximal end of thecurved region 120 a, and anend region 120 c at a distal end of thecurved region 120 a. The depictedcurved region 120 a is C-shaped. It can alternatively be semi-elliptical, and in certain embodiments semi-circular with a radius ofcurvature 121 of between about 0.125 inches and about 0.75 inches, though this length can be larger or smaller as desired. The substantiallylinear region 120 b of thehead 120 is configured to have a desired length. Theregion 120 b shown inFIG. 1A is between about 0.125 inches and about 0.5 inches in length to allow thehead 120 to fit properly through the sacrospinous ligament or coccygeus muscle, though this length can be larger or smaller as desired. The substantiallylinear region 120 b includes alongitudinal axis 123 oriented to be substantially perpendicular to thelongitudinal axis 111 of theshaft 105. However, in alternative embodiments theaxes length 107 of theshaft 105 along theaxis 111 is about ten times longer than thelength 108 of thehead 120 along theaxis 111. - As noted, the
head 120 also includes anend region 120 c.FIG. 2A shows a close-up view of thehead 120 of thedevice 100 and in particular, theend region 120 c. As shown, theend region 120 c has atip 130 that extends along alongitudinal axis 131 which intersects thelongitudinal axis 111 of theshaft 105, such that the end of thetip 130 is substantially equiplanar with thelongitudinal axis 111. Thetip 130 is sharp and configured to dissect tissue material, including contractile tissue, epithelium, and/or connective tissue. Thetip 130 is preferably sharp enough to dissect muscle and ligament. As discussed below, in one exemplary method, thetip 130 is associated with an implant and driven through a target region in the sacrospinous ligament, coccygues muscle, iliococcygeus muscle, and/or the levator ani muscle. In alternate embodiments, as depicted inFIG. 2B , thetip 130 is blunt, allowing for the blunt dissection of tissue. - As shown in
FIG. 2A , thetip 130 further includes ashoulder 225 which provides a stopping mechanism for an implant associator of a surgical implant, as discussed below with reference toFIGS. 5-6 . As illustrated, theshoulder 225 is generally shaped as a circular step that juts out from thetip 130, resulting in the end-region 120 c having varying cross-sections. More specifically, across section 134 of the device taken in a location proximal to the shoulder (i.e., away from the tip) has a larger radius than a radius of across section 136 of the device taken in a location just distal to the shoulder (i.e., toward the tip). - With continued reference to
FIG. 2A , thedevice 100 also includes ajunction 124 that connects thehead 120 and theshaft 105, and in particular connects the substantiallylinear region 120 b of thehead 120 to thedistal end 105 a of theshaft 105. The depictedjunction 124 is curved. In certain embodiments, thejunction 124 has a radius ofcurvature 140 between about 0.1 inches and about 0.7 inches. The radius ofcurvature 140 may be smaller or larger than the radius ofcurvature 121 of thecurved region 120 a. Thejunction 124 alternatively need not be curved at all. Instead, thejunction 124 may include an angled junction formed by the substantiallylinear region 120 b and theshaft 105, with no intervening curvature. The appropriate radius ofcurvature 140 or angle of thejunction 124 can be chosen to suit a preferred method and location of delivery of the surgical implant. As discussed below, thejunction 124 may also include a hinge about which thehead 120 is rotatable. -
FIG. 3 shows analternative embodiment 300 of the device ofFIG. 1A having ahead 320 oriented perpendicularly to theshaft 305 to allow the operator to deliver a surgical implant to a region of a patient's levator ani muscle, such as the tendinous arch of the levator ani or the iliococcygeus muscle, through a vaginal incision. The levator ani muscle is a broad, thin muscle situated generally on the side of the pelvis that is attached to the inner surface of the lesser pelvis. It is a convenient location to anchor mesh straps in order to provide lateral and/or posterior support and tension for a surgical implant. The iliococcygeus is a portion of the levator ani muscle originating from the ischial spine and the arcus tendineus levator ani and sloping inferiorly toward the midline. The iliococcygeus includes fibers that blend with the longitudinal muscle of the rectum. - As shown, the
delivery device 300 is similar to thedevice 100, but itshead 320 is positioned about 90 degrees clockwise 350 with respect to the operator of the device to allow thehead 320 to align next to the levator ani muscle when thedevice 300 is passed through a vaginal incision. Generally, thehead 320 of thedevice 300 lies substantially in a plane, and thelongitudinal axis 311 of theshaft 305 is normal to the plane. Thehead 320 traces a counter clockwise 360 path from itslinear region 320 b to itstip 330 with respect to a distally-looking vantage of the delivery device (i.e., with respect to an operator's vantage). This configuration allows the operator to position the implant through a vaginal incision next to the levator ani muscle so the head 120 (coupled to the implant strap) can be driven into the muscle, thereby inserting the strap into the muscle to secure the implant. -
FIG. 4 shows analternative embodiment 400 of thedevice 100 ofFIG. 1 a having ahead 420 oriented on the contra lateral side of itsshaft 405 compared to thehead 320 andshaft 305 ofFIG. 3 . Thedevice 400 is then suited to deliver a surgical implant, such as a pelvic floor mesh strap, to a region of a patient's levator ani muscle contra-lateral to the region of the levator ani muscle discussed with respect toFIG. 3 . More particularly, thedelivery device 400 is similar to thedevice 100, but with thehead 420 rotated by about 90 degrees counterclockwise 450 with respect to the operator of the device. Generally, thehead 420 of thedevice 400 lies substantially in a plane, and thelongitudinal axis 411 of theshaft 405 is normal to the plane. Thehead 420 traces a clockwise 460 path from the linear region 420 b to thetip 430, with respect to a distally-looking vantage of the delivery device (i.e., with respect to an operator's vantage). This configuration allows the operator to position the implant through a vaginal incision and next to the levator ani muscle, so the head 120 (with the implant strap) can be driven into the muscle, thereby inserting the strap into the muscle to secure the implant. - In other embodiments not illustrated, the head can be rotated by more or less than 90 degrees in either the counterclockwise 450 or clockwise 350 directions to allow the implant or its straps to be inserted within any ligaments, muscles or other desired pelvic tissues. In these cases, the heads will lie substantially in a plane, and the respective longitudinal axes of the shaft will have a non-normal incidence with the plane. The appropriate incidence angle can be chosen to facilitate insertion of the device using a preferred method and location for delivery.
- In certain embodiments, the
shafts delivery devices shaft 105 of thedelivery device 100. This is beneficial because the sacrospinous ligament and coccygeus muscle are located posterior to the tendinous arch of the levator ani muscle and the iliococcygeus muscle. Theshafts respective heads shaft 105 is generally between about 15% and about 50% longer than theshafts shafts -
FIG. 5 more particularly shows an exemplary device, such as thedevice 100 ofFIG. 1A , in operation with an implantable mesh strap assembly including animplant 505. The depictedimplant 505 is amesh strap 505 portion of a surgical implant assembly that can be used to treat pelvic floor disorders, UI, or other conditions. Theimplant 505 is configured to couple with thetip 130 ofdevice 100 for delivery of theimplant 505 to a target tissue region. It is to be understood that theother tips devices mesh strap 505. - As shown, the
mesh strap 505 includes animplant associator 510 for associating with thetip 130 of thedelivery device 100, and in certain embodiments theimplant associator 510 also anchors themesh strap 505 in tissue. The depictedimplant associator 510 has aring 509 andwings ring 509 over thetip 130 and thering 509 slides down thetip 130 until thering 509 abuts theshoulder 225. The step orshoulder 225 of the end-region 120 c prevents passage of thering 509 in a direction that is proximal and further down 515 along the delivery device. - The
ring 509 includes an inner surface 507 that is tapered, and thereby thering 509 inter-fits with theouter surface 226 of thetip 130. The depictedring 509 is coplanar with themesh strap 505. - The
wings implant associator 510 extend radially from thering 509 and form anangle 512. The angle allows thewings mesh strap 505 in a desired location. In one embodiment, theimplant associator 510 is flexible such that theangle 512 can be increased or decreased upon application of appropriate mechanical pressure. By way of example, if themesh strap 505 is passed through tissue in aforward direction 580, thewings angle 512. If themesh strap 505 is passed through tissue in aretrograde direction 582, thewings angle 512. The varyingangle 512 facilitates movement of themesh strap 505 in theforward direction 580, and impedes movement of themesh strap 505 in theretrograde direction 582. Theangle 512 formed between thewings connector 505. These properties are generally chosen to suit the particular delivery path location for delivering the implant, as well as the condition being treated. In certain exemplary embodiments, wings 511 a-b are not included and thering 509 is molded, glued or otherwise affixed to the mesh so that, by itself, it couples themesh strap 505 and theend region 120 c. Thering 509 ofimplant associator 510 can have varying thicknesses and/or varying lengths. -
FIG. 6 shows thedelivery device 100 coupled with themesh strap 505 ofFIG. 5 . The end-region 120 c of thedevice 100 protrudes through thering 509 even after thedevice 100 has been associated with themesh strap 505. This allows thedelivery device 100 to dissect tissue as it implants themesh strap 505. In operation, thetip 130 of the device is pushed into the tissue and the associatedring 509 follows into the tissue. -
FIG. 7 shows themesh strap 505 ofFIGS. 5-6 , with analternative implant associator 514. The implant associator 514 includes aring 513 that has circular cross-sections lying in a plane that is perpendicular to a plane of the mesh strap. The implant associator 514 is, in certain embodiments, used in operative combination with the delivery devices described herein. The alternative orientation of thering 513 with respect toimplant associator 514 in comparison to thering 509 with respect toimplant associator 510 results in a different orientation of themesh strap 505 with respect to thedelivery device 100 when themesh strap 505 and thedevice 100 are coupled. This alternative orientation results in thestrap 505 aligning with the end-region 120 c of thehead 120, as opposed to extending from the end-region 120 c of thehead 120 at about a 90 degree angle as illustrated inFIG. 6 . The alternative orientation usingimplant associator 514 may be preferred by a medical operator when the operator is delivering themesh strap 505 through a narrow anatomical incision and/or a narrow pathway through a patient's anatomy. - Other exemplary alternatives to implant associators 510 and 514 as well as alternate configurations for the
tip 130 and/or endregion 120 c of thedevice 100 are disclosed in U.S. patent application Ser. No. 10/542365 and U.S. patent application Ser. No. 11/152898, the contents of which are incorporated by reference herein in their entirety. - As noted above, the devices can be used to deliver implants to patient tissue.
FIG. 8 more particularly depicts the use ofdevice 300 ofFIG. 3 to implant amesh strap 505 through aregion 810 of thelevator ani muscle 810, more particularly, about the tendinous arch of the levator ani muscle or “white line” 805. - In operation, the operator associates the
mesh strap 505 with thedelivery device 300 usingimplant associator 510. The operator then places thetip 330 of thedelivery device 300 proximal to atarget tissue region 810. The operator rotates thedevice 300 counter clockwise along alongitudinal axis 311 of theshaft 305 of thedevice 300, applying sufficient force to theshaft 305 to cause thetip 300 to dissect tissue and trace apath 811 below and around thetendinous arch 805 of the levator ani muscle. Thetip 330 exits the tissue near atissue region 812, while themesh strap 505 remains associated with thedevice 300 viaimplant associator 510. The user then retracts thedevice 300, leavingmesh strap 505 implanted in the levator ani muscle, by rotating thedevice 300 in a clockwise direction about thelongitudinal axis 311. Upon retraction, theimplant associator 510 dissassociates from thedelivery device 300 when theback side 510 a of theimplant associator 510 abuts against the tissue surface neartissue region 812, thereby preventing theimplant associator 510 from continuing in a retrograde direction alongpath 811. In certain embodiments, themesh strap 505 includes tanged edges or barbs to help anchor the strap in surrounding tissue proximal to thepath 811. - To assist in the retraction, the operator may use a tonged forceps instrument or other tong-like or tweezer-like instrument (not shown) to grasp and hold in place the
implant associator 510 as thedevice 300 is retracted. In certain embodiments, the operator grasps theimplant associator 510 with the forceps and pulls theimplant associator 510 away from thetip 330, thereby dissassociating themesh strap 505 from thedelivery device 300, before retracting thedelivery device 300. Optionally, after thedelivery device 300 is retracted, the operator uses the forceps instrument to grasp theimplant associator 510 and pull theimplant associator 510 generally away from thetissue region 812. This allows the operator to tension an implant, as discussed further below. - Alternately, the operator can use the
device 400 ofFIG. 4 to carry out the above procedure. In such an implementation, the operator inserts thedevice 400 above thewhite line 805 using a clockwise rotation for insertion and a counterclockwise rotation for retraction. In that case, the insertion will benear tissue region 812, and thetip 430 will exit the tissue nearregion 810. - As shown, the devices described above include a head that is fixed to a shaft. In certain alternative embodiments, the head and shaft are configured to rotate with respect to each other, thereby allowing the operator to adjust the placement of the head without moving the shaft.
FIG. 9 shows such an exemplaryalternative delivery device 900 including ashaft 905 with adistal end 905 a and a proximal end (not shown) opposite thedistal end 905 a, and ahead 920, connected to theshaft 905 by pivotable junction 924. - The pivotable junction 924 allows the
head 920 to rotate about thedistal end 905 a of theshaft 905, and in particular about anaxis 925 indirections shaft 905. As shown, theaxis 925 is perpendicular to thelongitudinal axis 911 of theshaft 905 and normal to the plane of therotatable head 920. - In certain embodiments, the pivotable junction 924 is adjustable to fix the position of the
head 920 with respect to theshaft 905 at a desired position. In particular, the depicted junction 924 may include a hinge and pin assembly for fitting into aslot 927 about which thehead 920 rotates. The hinge 924 and pin assembly can be configured to provide sufficient tightness such that therotatable head 920 can be manually rotated to a desired position upon application of appropriate mechanical force to thehead 920, and then remain substantially fixed in that position upon insertion of the pin into theslot 927. The pin can be released from theslot 927 to allow thehead 920 to freely rotate about theshaft 905, and then pushed fully into itsslot 927 to fix thehead 920 at a preferred orientation. - Also shown, the
device 900 has astop surface 926 that restricts the range of motion of therotatable head 920. Operatively, asurface 920 a ofrotatable head 920 aligns with thestop surface 926, thereby preventing further rotation of therotatable head 920 in thedirection 930. Thestop surface 926 can be oriented at varying angles with respect to thelongitudinal axis 911 in order to alter the angle beyond which rotation is prevented. As described below, the rotatable head feature allows an operator to adapt the configuration of thehead 920 to facilitate insertion into various anatomical locations of a patient. - In an alternative embodiment, the
device 900 is configured to rotate about anaxis 935, which is tangential to therotatable head 920 atregion 920 b, where thehead 920 meets theshaft 905. This embodiment enables an operator to modify the orientation of thehead 920 to be similar to the 90 degree angled configurations of theheads FIGS. 3-4 , or to be oriented with other preferred angles. In one exemplary embodiment, rotation about theaxis 935 is accomplished by inserting a pin in theshaft 911, the pin's longitudinal axis being aligned withaxis 935, atlocation 905 c with a point of the needle extending indirection 933. - In still another embodiment, the junction 924 allows the device to rotate about any of
axes shaft 905 and thehead 920 ofdevice 900 are substantially similar to theshaft 105 and thehead 120 of thedevice 100 ofFIG. 1 , and the various alternative embodiments and features of other delivery devices described herein may apply todevice 900. - In operation, the
device 900 can be used to secure one or more mesh straps of a surgical implant to a target tissue, for example the sacrospinous ligament or coccygeus muscle. In an exemplary method, an operator first couples a mesh strap 505 (not shown inFIG. 9 ) to thedevice 900 using an implant associator 510 (not shown inFIG. 9 ) as described above. The operator then positions thedevice 900 so that itstip 930 overlies atarget region 940 a of thetissue 940. Next, the operator applies appropriate torque to thedevice 900 from its handle (not shown) and thereby drives the tip through thetissue 940, as shown inFIG. 10 which depicts thehead 920 partially disposed within thetarget tissue 940. The operator may position a forefinger on thehead 920 for leverage, thereby rotating thehead 920 about the pivotable junction 924 and driving thehead 920 into thetissue 940 without moving theshaft 905. -
FIG. 11 shows thedevice 900 with itstip 930 associated withmesh strap 505 throughimplant associator 510 after having penetrated through thetarget tissue 940. The operator drives thehead 920 through thetissue 940, such that thetip 930, coupled withimplant associator 510, emerges through thetissue 940. The operator then retracts therotatable head 920, leaving the mesh implanted through thetissue 940 and anchored by theimplant associator 510. Alternatively, an operator uses a forceps or other tong-like instrument to prevent the connector from retracting through thetissue 940 as discussed above. Also as discussed above, themesh strap 505 may have tanged edges that help to anchor the strap in theligament 940. - The
delivery device 900 may, in one optional aspect, include acannula 950 disposed about theshaft 905. Thecannula 950 is operably coupled to therotatable pivot head 920 and is configured to control rotation of thehead 920. In particular, thecannula 950 includes adistal end 950 a that rotates the end of thepivot head 920 near or in contact with the junction 924 as desired by an operator. The operator may use external control mechanisms, such as knobs and/or buttons located near the handle (not shown) to rotate thehead 920. - An another embodiment, a
Miya hook 990, as shown inFIG. 12 , may be modified and used to place one or more mesh straps of an implant. The Miya hook 990 includes arounded head portion 992, ashaft 994, and scissor-like handles 996. Therounded head portion 992 and theshaft 994 are configured to rotate with respect to each other, thereby allowing the operator to adjust the placement of thehead portion 992 without moving the shaft. Thehead portion 992 includes ashoulder 993, such that the tip of thehead portion 992 may associate with an associator, such asimplant associator 510 ofFIG. 5 . - The illustrative embodiments discussed above illustrate devices and methods for securing a
mesh strap 505 to a target tissue, such as a muscle or a ligament. As mentioned above, themesh strap 505 can be a portion of a larger surgical implant which can be used for pelvic floor support and/or repair.FIG. 13A depicts an inferior view of apelvic floor implant 960 positioned within a patient by the use of one or more of the devices described herein. As shown, theimplant 960 includes acentral region 964 and a plurality of straps 962 a-962 f similar tomesh strap 505. The straps 962 a-962 f include twoanterior straps - While the depicted
implant 960 includes 6 straps, more or fewer straps may be used depending on the nature of the condition being treated, and exemplary embodiments include 2, 3, 4, or 5 straps. For example, if a medical operator determines that a patient requires posterior support but not anterior support, an implant may consist of fourstraps 962 c-962 f, but not straps 962 a-962 b. - The
mesh implant 960 is sized and shaped to fit on or near the pelvic floor and support the bladder, the vagina, and/or the rectum. The straps 962 a-962 f are spaced apart so as to align with particular anatomical locations within the pelvic region for securing theimplant 960 thereto. As shown in the depicted example, theanterior straps regions Posterior straps levator ani muscle 973, only a portion of which is depicted inFIG. 13A , andposterior straps sacrospinous ligament 975, only a portion of which is depicted inFIG. 12 . In an alternative embodiment, theposterior straps implant associator 510. - In one aspect, the devices and systems described herein may be used in surgical procedures to treat a patient suffering from pelvic floor disorders or urinary incontinence. An exemplary technique for implanting and securing the
surgical mesh 960 in an anatomy of a patient is now described. - The exemplary technique consists of three phases. In a first phase, the operator inserts and secures the posterior straps 960 e and 960 f into the sacrospinous ligament, the coccygeus muscle, or both the sacrospinous ligament and coccygeus muscle. In a second phase, the operator inserts and secures the
posterior straps anterior straps - More particularly, in the first phase, to insert the
strap 962 e a medical operator creates an incision in a patient's anterior vaginal wall (not shown). The incision can be dissected or extended as required to facilitate access ofdelivery device 100 to targetregion 974 e. Next, the operator couples, preferably external to the body,mesh strap 962 e withdelivery device 100 via an implant associator (not shown) similar toimplant associator 510. The operator then inserts thedevice 100 and coupledmesh strap 962 e through thevaginal opening 972, into the vaginal canal, and through the vaginal incision. The operator pierces and drives themesh strap 962 e through thetarget region 974 e of the sacrospinous ligament, and then retracts the device, using methods similar to those described above. As mentioned above, the operator may use forceps to facilitate the disassociation of thedelivery device 100 from themesh strap 962 e. - The operator then delivers the
mesh strap 962 f through thevaginal opening 972 and through the vaginal incision in a similar manner as 962 e. The vaginal incision may be dissected or extended as necessary to facilitate access ofdelivery device 100 to targetregion 974 f. The operator may use thesame delivery device 100 for delivery ofstrap 962 f, or alternatively may use asecond delivery device 100. - The first phase can also be carried out using
delivery device 900 ofFIG. 9 ordelivery device 101 ofFIG. 1B instead ofdelivery device 100. The use ofdelivery device 900 is beneficial in part because the operator can adjust the rotation of therotatable head 920 to suit the operator's preference and/or the particular anatomy of the patient. The use ofdelivery device 101 is beneficial in part because itscurved shaft 103 may facilitate passage of the device through the vaginal canal in order to access thetarget regions - In the second phase, the operator inserts the
straps target regions strap 962 c, the operator first couplesdelivery device 300 to themesh strap 962 c using an implant associator (not shown), then inserts thedevice 300 into the vaginal canal, and through the vaginal incision. The vaginal incision provides access to thetarget region 974 c in part because thehead 320 of thedevice 300 is rotated so itstip 330 aligns with thetarget region 974 c. However, if the rotatedhead 320 does not align withtarget region 974 c using the vaginal incision in a particular patient's anatomy, the operator can choose adevice 900 and adjust the rotation ofrotatable head 920 to align thetip 930 withtarget region 974 c. - With the
device 300 appropriately placed proximal to thetarget tissue region 974 c, the operator then pierces and drives themesh strap 962 c through thetarget region 974 c of the levator ani muscle, and retracts thedelivery device 300 using the method discussed with respect toFIG. 8 . - The operator similarly delivers
mesh strap 962 d to targetregion 974 d of the tendinous arch of the levator ani muscle contra-lateral to targetregion 974 c usingdelivery device 400. Similar todelivery device 300 accessingtarget region 974 c,device 400 accessestarget region 974 d through the vaginal incision used to deliverstrap 962 f. Alternatively, the operator can choose adevice 900 and adjust the rotation ofrotatable head 920 to align thetip 930 withtarget region 974 d. - In a third phase, the operator inserts the
anterior straps - More particularly, according to one method of use, an operator implants the
anterior strips vaginal opening 972. The operator creates such a passage on each side of the patient. In order to create the passages, the delivery devices may include needles and/or dilators having curved portions that can trace paths through an obturator foramen located generally at 976 a or 976 b, through the vaginal incision in the anterior vaginal wall, and ultimately to a region externally accessible viavaginal opening 972. By way of example,FIG. 15A shows adelivery device 983 that can deliveranterior strap 962 a, andFIG. 15B shows adelivery device 984 that can deliveranterior strap 962 b. Alternatively,device 985, depicted in various perspectives inFIGS. 16A , 16B, and 16C, can deliveranterior strap 962 b, while a symmetric device can deliveranterior strap 962 a. - In one implementation of the anterior straps, two incisions are made on the body of the patient. A first incision is made just to the side of the edge of the ishiopubic ramus in the region of the urethral meatus. A second incision, corresponding to the first incision, is made on the contra-lateral side. In an inside-out approach, the
strap 962 a is associated with thedelivery device 983 ofFIG. 15A , which is inserted through the vaginal incision toward the obturator foramen. Thedelivery device 983 pierces the obturator membrane, and the tip of thedelivery device 983 along with the end of thestrap 962 a exits the patient tissue through the first incision. The operator delivers and securesstrap 962 b by repeating this process symmetrically withdelivery device 984 on the contra-lateral side of the body. - In an alternative approach, the operator extends the
delivery device 983 to an anatomical position in front of the obturator membrane without piercing the membrane. In this approach, thestrap 962 a is configured with soft tissue anchor end portions for anchoring into the soft tissue in front of the membrane. Sling assemblies with soft tissue anchors and devices and methods for applying slings with soft tissue anchors are disclosed, for example, in commonly assigned U.S. patent application Ser. No. 11/400111, filed Apr. 6, 2006 and entitled “Systems, Devices and Methods for Treating Pelvic Floor Disorders,” U.S. patent application Ser. No. 11/399913, filed Apr. 6, 2006 and entitled “Systems, Devices and Methods for Suburethral Support,” and U.S. patent application Ser. No. 11/152898, filed Jun. 14, 2005 and entitled “Systems, Methods and Devices Relating to Implantable Supportive Slings,” the contents of each of which are incorporated by reference herein in their entirety. - In an outside-in approach, the
delivery device 983 ofFIG. 15A is inserted through one ishiopubic incision, piercing the obturator muscle and obturator membrane. A forefinger is placed in the vaginal incision and on the distal end of the delivery device. The forefinger is used to guide the distal end ofdelivery device 983 around the ishiopubic ramus through the vaginal incision. - Next, the operator associates strap 962 a with the
delivery device 983. Thedelivery device 983 and themesh strap 962 a can be associated with any of the implant associators discussed herein, or the implant association techniques discussed in U.S. patent application Ser. No. 10/542365. For example, thedelivery device 983 may include an L-slot near the distal tip, which may be used to associate themesh strap 962 a with thedelivery device 983, such that the delivery device can pull themesh strap 962 a back out through the ischiopubic incision. - The
delivery device 983 is then withdrawn from the ischiopubic incision, drawing the end of themesh strap 962 a through the passage created by thedelivery device 983. Finally, the operator delivers and securesstrap 962 b by repeating this process symmetrically withdelivery device 984 on the contra-lateral side of the body. -
FIG. 13B shows a lateral view of the pelvic region of the patient, and more particularly shows thedevice 100 aligned with thesacrospinous ligament 975, and thedevice 300 aligned with the tendinous arch of thelevator ani muscle 973, of which only a portion is shown. Theimplant 960 is not shown. - The straps and incisions need not be inserted or made, respectively, in the order described above. An operator can choose any suitable order for creating incisions and delivering straps 962 a-962 f. The operator, at his discretion, optionally performs one or more cystoscopies after inserting one or more of the mesh straps 962 a-962 f to check for damage to the bladder.
- In one embodiment, for posterior pelvic floor support, the anterior straps 962 a-962 b may be cut off or otherwise removed from the
implant 960. The anterior straps 962 a-962 b may be removed from theimplant 960 before implantation. In this embodiment, thecentral region 964 of theimplant 960 may be sutured or otherwise attached to the pubococcygeus muscle and/or the anterior portion of the tendinous arch of the levator ani muscle. - The exemplary three phase technique described above employed various ones of the
delivery devices handle 119 shown inFIG. 8 that is color-coded to match the color of the implant associator corresponding to the mesh strap 962 a-962 f that the device delivers. The operator can thereby visually identify which of thedevices device 100, can be used to deliver multiple straps, thedevice 100 may include ahandle 119 with multiple color codes. Other visual indications or markers may also be used. - Other delivery methods can be used for
implant 960. For example, suprapubic, prepubic, and transvaginal approaches, disclosed in the patents and patent applications cited herein, can be used to delivery one or more of the straps 962 a-962 f. All operative combinations between the disclosed delivery devices and these alternative procedures are contemplated. Any of the delivery devices described above may be employed to create appropriate passageways to target regions in a patient's anatomy. - After the mesh straps 962 a-962 f are in place near their respective target regions 974 a-f, the operator adjusts the tension of the
implant 960 by pulling the mesh straps 962 a-962 f further through their respective target tissue regions. In certain implementations, an operator inserts a forceps through one of the vaginal incisions to one of the target regions 962 a-962 f. The operator may grasp and pull a respective implant associator (not shown) and thereby pull the respective mesh strap 962 a-962 f further through its tissue or ligament, as described above. This increases the tension of the implant. The operator may perform this process for one or more of the mesh straps until the desired tension is achieved. - Other methods of delivering and securing the mesh are envisioned. In some embodiments, the mesh straps, such as mesh straps 962 a-962 f, are not driven through muscle or ligament, but instead are anchored into general surrounding tissue by barbs or tangs on the edges and/or surfaces of the
implant 960 and/or its straps 962 a-962 f. The straps 962 a-962 f can alternately be secured to soft tissue regions of the pelvic floor using soft tissue anchors as discussed in U.S. Provisional Application No. 60/715362, the contents of which are incorporated herein by reference in their entirety. Alternatively, one or more of the straps 962 a-962 f may be secured to target tissue regions by suturing the straps. For example, straps 962 c-f can be sutured to target tissue regions of the levator ani muscle and/or the sacrospinous ligament. - In another aspect, the invention includes a kit with devices for use in supporting or repairing pelvic floor problems.
FIG. 14 illustrates an exemplarysurgical kit 980 for use in surgery related to pelvic floor repair. Thekit 980 includes these devices—device 100,device 300, anddevice 400. In certain embodiments, theshafts shaft 105 is between about 15% and 60% longer thanshafts shaft 105 is about 20% longer thanshafts - Optionally, the kit also includes one or more surgical implants, such as the
implant 960. In this illustration, the straps 962 a-962 f are coupled with respective implant associators similar toimplant associator 510, however in alternate embodiments the implant associators can be provided in the kit separate from the straps 962 a-962 f or may not be provided at all. - In another optional embodiment, the
kit 980 includes one or more of thedevices FIG. 15A andFIG. 15B . Additionally or alternatively, thekit 980 may include one or more ofdevice 985 ofFIGS. 16A-16C , as well as a symmetric device for use on a contra-lateral side of a patient. Thekit 980 may additionally or alternatively include one or more of the delivery devices discussed in U.S. patent application Ser. No. 10/957926 and/ordevice 101 ofFIG. 1B . In alternative embodiments,device 900 is provided with (or without) one or more of the devices included inkit 980. -
FIGS. 15A and 15B depict a pair ofdelivery devices devices FIG. 12A is discussed. Thehandle 987 of thedelivery device 983 includes afirst section 987 a extending along a first longitudinal axis substantially in a first plane. Asecond section 987 b of thehandle 987 extends distally from, but at an angle to, the axis of thefirst section 987 a. The first 987 a and second 987 b sections of thehandle 987 are substantially coplanar in the first plane. Ashaft 989 includes a curved section that extends from a mounting location at a distal end of thesecond handle section 987 b. The curved section first extends out of the first plane of the first 987 a and second 987 b handle sections, then extends back toward the first plane. In some configurations, thedistal tip 989 a (conically shaped in the illustrative embodiment) of thedelivery device 983 extends back through the first plane. In other configurations, thedistal tip 989 a extends up to or short of the first plane. According to one feature, theshaft 989 rotates about an axis that is substantially orthogonal to the first plane. However, according to other illustrative embodiments, the axis need not be substantially orthogonal to the first plane. According to alternative illustrative embodiment, at least one of the first 987 a and second 987 b sections of thehandle 987 tapers to have a narrower width as thehandle 987 extends distally toward the shaft. -
FIGS. 16A-16C depict various views of adelivery device 985 having ahandle 991 with first 991 a and second 991 c substantially straight sections located substantially in a first plane and angled relative to each other at 991 b, atransitional portion 993 extending out of a distal end of thehandle 991, and ashaft 995 extending from a distal end of thetransitional portion 993. The shaft includescurved section 995 a, astraight section 995 b, and terminates in aconical tip 995 c. - The
transitional portion 993 interfits and extends axially out of the distal end of thesecond handle section 991 c to affix theshaft 995 to thehandle 991. As a result, thetransitional portion 993 is substantially co-planar with thehandle 991 in the first plane. Thecurved section 995 a of theshaft 995 extends from a distal end of thetransitional portion 993. Thestraight section 995 b of theshaft 995 extends from a distal end of thecurved section 995 a. Thecurved section 995 a and thestraight section 995 b are substantially coplanar in a second plane. According to the illustrative embodiment ofFIGS. 16A-16C , the first and second planes are substantially orthogonal to each other. However, the first and second planes may be at any suitable angle (e.g., about 10, 20, 30, 45, 60, 70 or 80 degrees) to each other. In another illustrative embodiment ofFIGS. 16A-16C , the first andsecond sections handle 991 are at an angle of about 150 degrees to each other. However, first andsecond sections handle 991 may be at any suitable angle (e.g., about 80, 90, 100, 110, 120, 130, 140, 160, 170 or 180 degrees) to each other. - To provide structural reinforcement,
sections handle 991. Additionally, rather than having the tapered section of the transitional portion being formed as part of the shaft, thetapered portions FIG. 16 are formed as part of thehandle 991. According to one feature, this configuration reduces the length of thetransitional portion 993 and thus, provides improved structural support for thecurved section 995 a. Preferably, in operation, neither thehandle 991 nor thetransitional portion 993 extends into the body of the patient, and the angle attransitional portion 993 provides a positive stop against this occurring. - As mentioned above, the surgical implants of this invention, such as
implant 960 ofFIG. 14 , are typically a mesh material. There are many possible mesh materials, and the sling may, in the alternative or in combination, be made of other types of materials. Exemplary mesh materials include, for example, synthetic materials, natural materials (e.g., biological) or a combination thereof. The mesh may be fabricated from any of a number of biocompatible materials, such as nylon, silicone, polyethylene, polyester, polyethylene, polyimide, polyurethane, polypropylene, fluoropolymers, copolymers thereof, combinations thereof, or other suitable synthetic material(s). The material may be, for example, a biodegradable synthetic material. The term “biodegradable,” as used herein, refers to the property of a material that dissolves in the body. Such materials may also be absorbed into the body, i.e., bioabsorbable. - Suitable bioabsorbable synthetic materials include, without limitation, polylactic acid (PLA), polyglycolic acid (PGA), poly-L-lactic acid (PLLA), poly(amino acids), polypeptides, human dermis and decellularized animal tissue. Human tissues may be derived, for example, from human cadaveric or engineered human tissue. Animal tissues may be derived, for example, from porcine, ovine, bovine, and equine tissue sources. The material may be an omnidirectional material, a material that has equivalent tensile strength from any direction, such as pericardium or dermis. Alternatively, the material may be an oriented material, a material that has a single direction where the tensile strength of the material is the highest. Oriented materials may include rectus fascia and/or facia lata, as well as oriented synthetic materials.
- Exemplary biodegradable polymers, which may be used to form the tubular mesh 100, in addition to those listed above, include, without limitation, polylactic acid, polyglycolic acid and copolymers and mixtures thereof, such as poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), polyglycolic acid [polyglycolide (PGA)], poly(L-lactide-co-D,L-lactide) (PLLA/PLA), poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D,L-lactide-co-glycolide) (PLA/PGA), poly(glycolide-co-trimethylene carbonate) (PGA/PTMC), poly(D,L-lactide-co-caprolactone) (PLA/PCL), and poly(glycolide-co-caprolactone) (PGA/PCL); polyethylene oxide (PEO); polydioxanone (PDS); polypropylene fumarate; polydepsipeptides, poly(ethyl glutamate-co-glutamic acid), poly(tert-butyloxy-carbonylmethyl glutamate); polycaprolactone (PCL), poly(hydroxy butyrate), polycaprolactone co-butylacrylate, polyhydroxybutyrate (PHBT) and copolymers of polyhydroxybutyrate; polyphosphazenes, poly(phosphate ester); maleic anhydride copolymers, polyiminocarbonates, poly[(97.5% dimethyl-trimethylene carbonate)-co-(2.5% trimethylene carbonate)], cyanoacrylate, hydroxypropylmethylcellulose; polysaccharides, such as hyaluronic acid, chitosan, alginates and regenerate cellulose; poly(amino acid) and proteins, such as poly(lysine), Poly(glutamic acid), gelatin and collagen; and mixtures and copolymers thereof.
- The
implant 960, either as a whole or on a fiber by fiber basis, may include an agent for release into the patient's tissues. One illustrative agent is a tissue growth factor that promotes, when applied to the patient's tissues in a pharmaceutically acceptable amount, well-organized collagenous tissue growth, such as scar tissue growth, preferably, in large quantities. According to one feature, the agent may or may not block or delay the dissolvability of the biodegradable materials. This may be controlled by selecting differing methods for loading the agent onto the sling. The tissue growth factor may include natural and/or recombinant proteins for stimulating a tissue response so that collagenous tissue such as scar tissue growth is enhanced. Exemplary growth factors that may be used include, but are not limited to, platelet-derived growth factor (PDGF), fibroblast growth factor (FGF), transforming growth factor-beta (TGF-beta), vascular endothelium growth factor (VEGF), Activin/TGF and sex steroid, bone marrow growth factor, growth hormone, Insulin-like growth factor 1, and combinations thereof. The agent may also include a hormone, including but not limited to estrogen, steroid hormones, and other hormones to promote growth of appropriate collagenous tissue such as scar tissue. The agent may also include stem cells or other suitable cells derived from the host patient. These cells may be fibroblast, myoblast, or other progenitor cells to mature into appropriate tissues. Besides applying active pharmaceutical agents, passive agents may be applied to promote tissue ingrowth. For example, titanium sputtering or chrome sputtering can be used. - In various illustrative embodiments, the agent may include one or more therapeutic agents. The therapeutic agents may be, for example, anti-inflammatory agents, including steroidal and non-steroidal anti-inflammatory agents, analgesic agents, including narcotic and non-narcotic analgesics, local anesthetic agents, antispasmodic agents, growth factors, gene-based therapeutic agents, and combinations thereof.
- Exemplary steroidal anti-inflammatory therapeutic agents (glucocorticoids) include, but are not limited to, 21-acetoxyprefnenolone, aalclometasone, algestone, amicinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumehtasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halobetasol priopionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methyolprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylaminoacetate, prednisone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortal, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, and pharmaceutically acceptable salts thereof.
- Exemplary non-steroidal anti-inflammatory therapeutic agents include, but are not limited to, aminoarylcarboxylic acid derivatives such as enfenamic acid, etofenamate, flufenamic acid, isonixin, meclofenamic acid, mefanamic acid, niflumic acid, talniflumate, terofenamate and tolfenamic acid; arylacetic acid derivatives such as acemetacin, alclofenac, amfenac, bufexamac, cinmetacin, clopirac, diclofenac sodium, etodolac, felbinac, fenclofenac, fenclorac, fenclozic acid, fentiazac, glucametacin, ibufenac, indomethacin, isofezolac, isoxepac, lonazolac, metiazinic acid, oxametacine, proglumetacin, sulindac, tiaramide, tolmetin and zomepirac; arylbutyric acid derivatives such as bumadizon, butibufen, fenbufen and xenbucin; arylcarboxylic acids such as clidanac, ketorolac and tinoridine; arylpropionic acid derivatives such as alminoprofen, benoxaprofen, bucloxic acid; carprofen, fenoprofen, flunoxaprofen, flurbiprofen, ibuprofen, ibuproxam, indoprofen, ketoprofen, loxoprofen, miroprofen, naproxen, oxaprozin, piketoprofen, pirprofen, pranoprofen, protizinic acid, suprofen and tiaprofenic acid; pyrazoles such as difenamizole and epirizole; pyrazolones such as apazone, benzpiperylon, feprazone, mofebutazone, morazone, oxyphenbutazone, phenybutazone, pipebuzone, propyphenazone, ramifenazone, suxibuzone and thiazolinobutazone; salicylic acid derivatives such as acetaminosalol, aspirin, benorylate, bromosaligenin, calcium acetylsalicylate, diflunisal, etersalate, fendosal, gentisic acid, glycol salicylate, imidazole salicylate, lysine acetylsalicylate, mesalamine, morpholine salicylate, 1-naphthyl salicylate, olsalazine, parsalmide, phenyl acetylsalicylate, phenyl salicylate, salacetamide, salicylamine o-acetic acid, salicylsulfuric acid, salsalate and sulfasalazine; thiazinecarboxamides such as droxicam, isoxicam, piroxicam and tenoxicam; others such as ε-acetamidocaproic acid, s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amixetrine, bendazac, benzydamine, bucolome, difenpiramide, ditazol, emorfazone, guaiazulene, nabumetone, nimesulide, orgotein, oxaceprol, paranyline, perisoxal, pifoxime, proquazone, proxazole and tenidap; and pharmaceutically acceptable salts thereof.
- Exemplary narcotic analgesic therapeutic agents include, but are not limited to, alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, codeine methyl bromide, codeine phosphate, codeine sulfate, desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levorphanol, lofentanil, meperidine, meptazinol, metazocine, methadone hydrochloride, metopon, morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenadoxone, phenazocine, pheoperidine, piminodine, piritramide, proheptazine, promedol, properidine, propiram, propoxyphene, rumifentanil, sufentanil, tilidine, and pharmaceutically acceptable salts thereof.
- Exemplary non-narcotic analgesic agents that may be combined with the slings of the invention include, but are not limited to, aceclofenac, acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid, alclofenac, alminoprofen, aloxiprin, aluminum bis(acetylsalicylate), aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine, ammonium salicylate, amtolmetin guacil, antipyrine, antipyrine salicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen, benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide, 5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin, calcium acetylsalicylate, carbamazepine, carbiphene, carsalam, chloralantipyrine, chlorthenoxazin(e), choline salicylate, cinchophen, ciramadol, clometacin, cropropamide, crotethamide, dexoxadrol, difenamizole, diflunisal, dihydroxyaluminum acetylsalicylate, dipyrocetyl, dipyrone, emorfazone, enfenamic acid, epirizole, etersalate, ethenzamide, ethoxazene, etodolac, felbinac, fenoprofen, floctafenine, flufenamic acid, fluoresone, flupirtine, fluproquazone, flurbiprofen, fosfosal, gentisic acid, glafenine, ibufenac, imidazole salicylate, indomethacin, indoprofen, isofezolac, isoladol, isonixin, ketoprofen, ketorolac, p-lactophenetide, lefetamine, loxoprofen, lysine acetylsalicylate, magnesium acetylsalicylate, methotrimeprazine, metofoline, miroprofen, morazone, morpholine salicylate, naproxen, nefopam, nifenazone, 5′nitro-2′propoxyacetanilide, parsalmide, perisoxal, phenacetin, phenazopyridine hydrochloride, phenocoll, phenopyrazone, phenyl acetylsalicylate, phenyl salicylate, phenyramidol, pipebuzone, piperylone, prodilidine, propacetamol, propyphenazone, proxazole, quinine salicylate, ramifenazone, rimazolium metilsulfate, salacetamide, salicin, salicylamide, salicylamide o-acetic acid, salicylsulfuric acid, salsalte, salverine, simetride, sodium salicylate, sulfamipyrine, suprofen, talniflumate, tenoxicam, terofenamate, tetradrine, tinoridine, tolfenamic acid, tolpronine, tramadol, viminol, xenbucin, zomepirac, and pharmaceutically acceptable salts thereof.
- Exemplary local anesthetic therapeutic agents include, but are not limited to, ambucaine, amolanone, amylocaine hydrochloride, benoxinate, benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, butaben, butanilicaine, butethamine, butoxycaine, carticaine, chloroprocaine hydrochloride, cocaethylene, cocaine, cyclomethycaine, dibucaine hydrochloride, dimethisoquin, dimethocaine, diperadon hydrochloride, dyclonine, ecgonidine, ecgonine, ethyl chloride, beta-eucaine, euprocin, fenalcomine, fomocaine, hexylcaine hydrochloride, hydroxytetracaine, isobutyl p-aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine, mepivacaine, meprylcaine, metabutoxycaine, methyl chloride, myrtecaine, naepaine, octacaine, orthocaine, oxethazaine, parethoxycaine, phenacaine hydrochloride, phenol, piperocaine, piridocaine, polidocanol, pramoxine, prilocaine, procaine, propanocaine, proparacaine, propipocaine, propoxycaine hydrochloride, pseudococaine, pyrrocaine, ropavacaine, salicyl alcohol, tetracaine hydrochloride, tolycaine, trimecaine, zolamine, and pharmaceutically acceptable salts thereof.
- Exemplary antispasmodic therapeutic agents include, but are not limited to, alibendol, ambucetamide, aminopromazine, apoatropine, bevonium methyl sulfate, bietamiverine, butaverine, butropium bromide, n-butylscopolammonium bromide, caroverine, cimetropium bromide, cinnamedrine, clebopride, coniine hydrobromide, coniine hydrochloride, cyclonium iodide, difemerine, diisopromine, dioxaphetyl butyrate, diponium bromide, drofenine, emepronium bromide, ethaverine, feclemine, fenalamide, fenoverine, fenpiprane, fenpiverinium bromide, fentonium bromide, flavoxate, flopropione, gluconic acid, guaiactamine, hydramitrazine, hymecromone, leiopyrrole, mebeverine, moxaverine, nafiverine, octamylamine, octaverine, oxybutynin chloride, pentapiperide, phenamacide hydrochloride, phloroglucinol, pinaverium bromide, piperilate, pipoxolan hydrochloride, pramiverin, prifinium bromide, properidine, propivane, propyromazine, prozapine, racefemine, rociverine, spasmolytol, stilonium iodide, sultroponium, tiemonium iodide, tiquizium bromide, tiropramide, trepibutone, tricromyl, trifolium, trimebutine, n,n-ltrimethyl-3,3-diphenyl-propylamine, tropenzile, trospium chloride, xenytropium bromide, and pharmaceutically acceptable salts thereof.
- According to another feature, the implants, such as implant 800, of the invention may include any suitable end portions, such as tissue dilators, anchors, and association mechanisms for associating the sling with the delivery devices of the invention. They may also include other slings, sling assemblies, sling delivery approaches, sling assembly-to-delivery device association mechanisms, and sling anchoring mechanisms. These and other features with which the delivery devices, implants, methods, and kits of the invention may be employed are disclosed in U.S. Pat. No. 6,042,534, entitled “Stabilization sling for use in minimally invasive pelvic surgery,” U.S. Pat. No. 6,755,781, entitled “Medical slings,” U.S. Pat. No. 6,666,817, entitled “Expandable surgical implants and methods of using them,” U.S. Pat. No. 6,042,592, entitled “Thin soft tissue surgical support mesh,” U.S. Pat. No. 6,375,662, entitled “Thin soft tissue surgical support mesh,” U.S. Pat. No. 6,669,706, entitled “Thin soft tissue surgical support mesh,” U.S. Pat. No. 6,752,814, entitled “Devices for minimally invasive pelvic surgery,” U.S. Ser. No. 10/918,123, entitled “Surgical Slings,” U.S. patent application Ser. No. 10/641,376, entitled “Spacer for sling delivery system,” U.S. patent application Ser. No. 10/641,192, entitled “Medical slings,” U.S. Ser. No. 10/641,170, entitled “Medical slings,” U.S. Ser. No. 10/640,838, entitled “Medical implant,” U.S. patent application Ser. No. 10/460,112, entitled “Medical slings,” U.S. patent application Ser. No. 10/631,364, entitled “Bioabsorbable casing for surgical sling assembly,” U.S. Ser. No. 10/092,872, entitled “Medical slings,” U.S. patent application Ser. No. 10/939,191, entitled “Devices for minimally invasive pelvic surgery,” U.S. patent application Ser. No. 10/774,842, entitled “Devices for minimally invasive pelvic surgery,” U.S. patent application Ser. No. 10/774,826, entitled “Devices for minimally invasive pelvic surgery,” U.S. Ser. No. 10/015,114, entitled “Devices for minimally invasive pelvic surgery,” U.S. patent application Ser. No. 10/973,010, entitled “Systems and methods for sling delivery and placement,” U.S. patent application Ser. No. 10/957,926, entitled “Systems and methods for delivering a medical implant to an anatomical location in a patient,” U.S. patent application Ser. No. 10/939,191, entitled “Devices for minimally invasive pelvic surgery,” U.S. patent application Ser. No. 10/918,123, entitled “Surgical slings,” U.S. patent application Ser. No. 10/832,653, entitled “Systems and methods for sling delivery and placement,” U.S. patent application Ser. No. 10/642,397, entitled “Systems, methods and devices relating to delivery of medical implants,” U.S. patent application Ser. No. 10/642,395, entitled “Systems, methods and devices relating to delivery of medical implants,” U.S. patent application Ser. No. 10/642,365, entitled “Systems, methods and devices relating to delivery of medical implants,” U.S. patent application Ser. No. 10/641,487, entitled “Systems, methods and devices relating to delivery of medical implants,” U.S. patent application Ser. No. 10/094,352, entitled “System for implanting an implant and method thereof,” U.S. patent application Ser. No. 10/093,498, entitled “System for implanting an implant and method thereof,” U.S. patent application Ser. No. 10/093,450, entitled “System for implanting an implant and method thereof,” U.S. patent application Ser. No. 10/093,424, entitled “System for implanting an implant and method thereof,” U.S. patent application Ser. No. 10/093,398, entitled “System for implanting an implant and method thereof,” and U.S. patent application Ser. No. 10/093,371, entitled “System for implanting an implant and method thereof,” U.S. Pat. No. 6,197,036, entitled “Pelvic Floor Reconstruction,” U.S. Pat. No. 6,691,711, entitled “Method of Correction of Urinary and Gynecological Pathologies Including Treatment of Incontinence,” U.S. Pat. No. 6,884,212, entitled “Implantable Article and Method,” U.S. Pat. No. 6,911,003, entitled “Transobturator Surgical Articles and Methods,” U.S. patent application Ser. No. 10/840,646, entitled “Method and Apparatus for Cystocele Repair,” U.S. application Ser. No. 10/834,943, entitled “Method and Apparatus for Treating Pelvic Organ Prolapse,” U.S. patent application Ser. No. 10/804,718, entitled “Prolapse Repair,” and U.S. patent application Ser. No. 11/115,655, entitled “Surgical Implants and Related Methods,” U.S. patent application Ser. No. 11/400111, entitled “Systems, Devices, and Methods for Treating Pelvic Floor Disorders,” and U.S. patent application Ser. No. 11/399913, entitled “Systems, Devices, and Methods for Sub-Urethral Support”. It is intended that the scope of the invention not be limited by this detailed description.
- The present disclosure contemplates all combinations of features and elements disclosed herein. For example, various embodiments of delivery devices, transfer pins, implants, implant associators, and other features described herein are interchangeable with one another, unless explicitly stated otherwise. As such, combinations of these embodiments, if not explicitly disclosed, are contemplated and within the scope of the present disclosure.
- The contents of all references, patents and published patent applications cited throughout this Application, as well as their associated figures are hereby incorporated by reference in entirety.
- The Figures and drawings referred to herein are not necessarily to scale; emphasis instead is generally placed upon illustrating the principles of the illustrated embodiments.
- Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill without departing from the spirit and the scope of the present disclosure. Hence, many equivalents to the specific systems, methods, and other embodiments described herein exist and are considered to be within the scope of the present disclosure. For additional illustrative features that may be used with the present disclosure, including the embodiments described here, refer to the documents listed herein above and incorporated by reference in their entirety. All operative combinations between the above described illustrative embodiments and those features described in the documents incorporated by reference herein are considered to be potentially patentable embodiments of the claimed invention.
Claims (38)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/906,969 US20080082105A1 (en) | 2006-10-03 | 2007-10-03 | Systems, devices and methods for treating pelvic floor disorders |
US13/850,150 US9539078B2 (en) | 2006-10-03 | 2013-03-25 | Systems, devices and methods for treating pelvic floor disorders |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US84919906P | 2006-10-03 | 2006-10-03 | |
US11/906,969 US20080082105A1 (en) | 2006-10-03 | 2007-10-03 | Systems, devices and methods for treating pelvic floor disorders |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US13/850,150 Division US9539078B2 (en) | 2006-10-03 | 2013-03-25 | Systems, devices and methods for treating pelvic floor disorders |
Publications (1)
Publication Number | Publication Date |
---|---|
US20080082105A1 true US20080082105A1 (en) | 2008-04-03 |
Family
ID=39047818
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/906,969 Abandoned US20080082105A1 (en) | 2006-10-03 | 2007-10-03 | Systems, devices and methods for treating pelvic floor disorders |
US13/850,150 Active 2028-07-29 US9539078B2 (en) | 2006-10-03 | 2013-03-25 | Systems, devices and methods for treating pelvic floor disorders |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US13/850,150 Active 2028-07-29 US9539078B2 (en) | 2006-10-03 | 2013-03-25 | Systems, devices and methods for treating pelvic floor disorders |
Country Status (3)
Country | Link |
---|---|
US (2) | US20080082105A1 (en) |
EP (1) | EP2097013B1 (en) |
WO (1) | WO2008042438A2 (en) |
Cited By (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080177132A1 (en) * | 2006-11-06 | 2008-07-24 | Caldera Medical, Inc. | Implants And Procedures For Treatment Of Pelvic Floor Disorders |
US20100191046A1 (en) * | 2009-01-05 | 2010-07-29 | Caldera Medical, Inc. | Implants And Procedures For Supporting Anatomical Structures |
US20100268018A1 (en) * | 2009-04-17 | 2010-10-21 | Boston Scientific Scimed, Inc. | Delivery sleeve for pelvic floor implants |
US20100274074A1 (en) * | 2007-09-21 | 2010-10-28 | Khamis Chaouki A | Pelvic floor treatments and related tools and implants |
US20110077456A1 (en) * | 2009-09-30 | 2011-03-31 | Bruce Drummond | Prolapse repair device and methods of use |
US20110196389A1 (en) * | 2010-02-09 | 2011-08-11 | Coloplast A/S | Digital suture fixation system |
US20110196386A1 (en) * | 2010-02-08 | 2011-08-11 | Coloplast A/S | Digital suture fixation system |
US20120029488A1 (en) * | 2010-07-29 | 2012-02-02 | Boston Scientific Scimed, Inc. | Adjustable device for delivering implants and methods of delivering implants |
US8282657B2 (en) | 2009-07-22 | 2012-10-09 | Coloplast A/S | Suturing system and assembly |
US20130178865A1 (en) * | 2012-01-06 | 2013-07-11 | Jai Singh | Insert and insert system for a laparoscopic instrument |
US8623033B2 (en) | 2011-07-20 | 2014-01-07 | Coloplast A/S | Suture system with capsule eyelet providing multiple suture tissue fixation |
WO2018005467A1 (en) * | 2016-06-29 | 2018-01-04 | Long William H | Subaxillary traction device to address shoulder dystocia during childbirth |
US9974639B2 (en) | 2007-12-28 | 2018-05-22 | Boston Scientific Scimed, Inc. | Devices and methods for treating pelvic floor dysfunctions |
CN111956284A (en) * | 2020-08-17 | 2020-11-20 | 王中显 | Sacrospinous ligament suturing device |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8262557B2 (en) | 2006-06-08 | 2012-09-11 | Ams Research Corporation | Method and apparatus for levator distension repair |
WO2008124056A1 (en) | 2007-04-04 | 2008-10-16 | Ams Research Corporation | Kit for levator avulsion repair |
AU2008271061B2 (en) | 2007-06-29 | 2013-11-14 | Boston Scientific Scimed, Inc. | Surgical articles and methods for treating pelvic conditions |
BRPI0814102A2 (en) | 2007-07-27 | 2015-02-03 | Ams Res Corp | PELVIC IMPLANT, AND, KIT. |
US8708887B2 (en) | 2008-05-29 | 2014-04-29 | Ams Research Corporation | Minimally invasive levator avulsion repair |
Citations (64)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4373530A (en) * | 1980-04-04 | 1983-02-15 | Lisa Ann Kilejian | Surgical stitching instrument |
US5152749A (en) * | 1991-06-28 | 1992-10-06 | American Medical Systems, Inc. | Instrument placement apparatus |
US5334185A (en) * | 1991-06-28 | 1994-08-02 | Giesy Consultants, Inc. | End-to-end instrument placement apparatus |
US5403328A (en) * | 1992-04-22 | 1995-04-04 | United States Surgical Corporation | Surgical apparatus and method for suturing body tissue |
US5520703A (en) * | 1993-06-07 | 1996-05-28 | Essig; Mitchell N. | Laparoscopic deschamp and associated suturing technique |
US5540704A (en) * | 1992-09-04 | 1996-07-30 | Laurus Medical Corporation | Endoscopic suture system |
US5843099A (en) * | 1997-01-16 | 1998-12-01 | Bei Medical Systems, Inc. | Single system ligature carrier and tissue clamp for sacrospinous colpopexy |
US5935138A (en) * | 1997-09-24 | 1999-08-10 | Ethicon, Inc. | Spiral needle for endoscopic surgery |
US5954057A (en) * | 1997-02-12 | 1999-09-21 | Li Medical Technologies, Inc. | Soft tissue suspension clip, clip assembly, emplacement tool and method |
US6056688A (en) * | 1991-12-03 | 2000-05-02 | Boston Scientific Technology, Inc. | Device and method for transvaginally suspending the bladder neck |
US6099538A (en) * | 1999-02-02 | 2000-08-08 | T.A.G. Medical Products | Set of surgical tools and surgical method for connecting soft bone parts to one another or to connective tissue |
US20010010008A1 (en) * | 1996-11-08 | 2001-07-26 | Gellman Barry N. | Protective sheath for transvaginal anchor implantation device |
US6273852B1 (en) * | 1999-06-09 | 2001-08-14 | Ethicon, Inc. | Surgical instrument and method for treating female urinary incontinence |
US20010018549A1 (en) * | 2000-01-21 | 2001-08-30 | Victor Scetbon | Percutaneous device and method for treating urinary stress incontinence in women using a sub-urethral tape |
US6319272B1 (en) * | 1996-11-08 | 2001-11-20 | Boston Scientific Corporation | Transvaginal anchor implantation device and method of use |
US20010053916A1 (en) * | 2000-06-05 | 2001-12-20 | Rioux Robert F. | Methods and devices for the treatment of urinary incontinence |
US20020055748A1 (en) * | 1997-02-13 | 2002-05-09 | Gellman Barry N. | Devices for minimally invasive pelvic surgery |
US20020068948A1 (en) * | 2000-05-01 | 2002-06-06 | Johan Stormby | Aiming device for surgical instrument and method for use for treating female urinary incontinence |
US20020077526A1 (en) * | 1999-06-09 | 2002-06-20 | Kammerer Gene W. | Surgical instrument and method for treating female urinary incontinence |
US20020091298A1 (en) * | 2000-10-20 | 2002-07-11 | Susanne Landgrebe | System with a surgical needle and a handle |
US20020099259A1 (en) * | 2001-01-23 | 2002-07-25 | Anderson Kimberly A. | Surgical instrument and method |
US20020099258A1 (en) * | 2001-01-23 | 2002-07-25 | Staskin David R. | Sling delivery system and method of use |
US20020151762A1 (en) * | 2001-01-23 | 2002-10-17 | Rocheleau Gary A. | Sling assembly with secure and convenient attachment |
US20020156488A1 (en) * | 2001-03-09 | 2002-10-24 | Gellman Barry N. | System for implanting an implant and method thereof |
US20020161382A1 (en) * | 2001-03-29 | 2002-10-31 | Neisz Johann J. | Implant inserted without bone anchors |
US6475139B1 (en) * | 1999-06-09 | 2002-11-05 | Ethicon, Inc. | Visually-directed surgical instrument and method for treating female urinary incontinence |
US20020188169A1 (en) * | 1999-06-09 | 2002-12-12 | Kammerer Gene W. | Surgical instrument and method for treating female urinary incontinence |
US6494887B1 (en) * | 1999-10-22 | 2002-12-17 | George Kaladelfos | Surgical instrument |
US20030004395A1 (en) * | 2000-10-05 | 2003-01-02 | Sofradim Production | Suburethral support assembly in treatment of female urinary stress incontinence |
US20030065246A1 (en) * | 2001-07-27 | 2003-04-03 | Inman Mona J. | Surgical instruments |
US20030078468A1 (en) * | 2001-10-22 | 2003-04-24 | Jeff Skiba | Biological vessel suspending assembly and systems and methods utilizing same |
US6595911B2 (en) * | 2001-04-03 | 2003-07-22 | Lovuolo Michael | Method and device for anchor implantation and support of bodily structures |
US20030191360A1 (en) * | 2000-10-12 | 2003-10-09 | James Browning | Apparatus and method for treating female urinary incontinence |
US6730110B1 (en) * | 1999-01-08 | 2004-05-04 | Ams Research Corporation | Tack device |
US20040087970A1 (en) * | 2001-03-09 | 2004-05-06 | Chu Michael S.H. | Systems, methods and devices relating to delivery of medical implants |
US20040097974A1 (en) * | 2002-08-29 | 2004-05-20 | Jean De Leval | Surgical procedure for the treatment of female urinary incontinence: tension-free inside-out transobturator urethral suspension |
US20040133217A1 (en) * | 2002-03-07 | 2004-07-08 | Ams Research Corporation | Handle and surgical article |
US20040144395A1 (en) * | 2002-08-02 | 2004-07-29 | Evans Douglas G | Self-anchoring sling and introducer system |
US6808486B1 (en) * | 2002-12-03 | 2004-10-26 | Pat O'Donnell | Surgical instrument for treating female urinary stress incontinence |
US20040225181A1 (en) * | 2003-04-25 | 2004-11-11 | Scimed Life Systems, Inc. | Systems and methods for sling delivery and placement |
US20050075660A1 (en) * | 2003-10-03 | 2005-04-07 | Chu Michael S. H. | Systems and methods for delivering a medical implant to an anatomical location in a patient |
US20050131392A1 (en) * | 2001-03-09 | 2005-06-16 | Scimed Life Systems, Inc. | Systems, methods and devices relating to delivery of medical implants |
US20050131393A1 (en) * | 2001-03-09 | 2005-06-16 | Scimed Life Systems, Inc. | Systems, methods and devices relating to delivery of medical implants |
US6911003B2 (en) * | 2002-03-07 | 2005-06-28 | Ams Research Corporation | Transobturator surgical articles and methods |
US20050177022A1 (en) * | 2003-11-17 | 2005-08-11 | Scimed Life Systems, Inc. | Systems and methods relating to associating a medical implant with a delivery device |
US20050197525A1 (en) * | 2000-11-15 | 2005-09-08 | Gellman Barry N. | Systems and methods for delivering a medical implant to an anatomical location in a patient |
US20050256366A1 (en) * | 2004-05-06 | 2005-11-17 | Chu Michael S H | Systems and methods employing a push tube for delivering a urethral sling |
US20050277807A1 (en) * | 2004-05-06 | 2005-12-15 | Maclean Brian | Systems and methods for sling delivery and placement |
US20060015069A1 (en) * | 2002-08-02 | 2006-01-19 | C.R. Bard, Inc. | Transobturator introducer system for sling suspension system |
US20060052800A1 (en) * | 2004-09-03 | 2006-03-09 | Secant Medical, Llc | Surgical tool for incontinence sling implantation |
US20060058578A1 (en) * | 2002-04-11 | 2006-03-16 | Gyne Ideas Limited | Apparatus and method for treating female urinary incontinence |
US20060058574A1 (en) * | 1999-06-09 | 2006-03-16 | Jorg Priewe | Method and apparatus for adjusting flexible areal polymer implants |
US20060089525A1 (en) * | 2004-06-14 | 2006-04-27 | Boston Scientific Scimed, Inc. | Systems, methods and devices relating to implantable supportive slings |
US20060089524A1 (en) * | 2004-10-25 | 2006-04-27 | Chu Michael S H | Systems and methods for sling delivery and placement |
US20060217589A1 (en) * | 2005-03-22 | 2006-09-28 | Wan Shaw P | Pubovaginal sling implanter and procedure for the usage |
US20060229596A1 (en) * | 2005-04-06 | 2006-10-12 | Boston Scientific Scimed, Inc. | Systems, devices, and methods for treating pelvic floor disorders |
US20060235262A1 (en) * | 2005-02-04 | 2006-10-19 | Arnal Kevin R | Needle design for male transobturator sling |
US7131943B2 (en) * | 2000-03-09 | 2006-11-07 | Ethicon, Inc. | Surgical instrument and method for treating organ prolapse conditions |
US20070015953A1 (en) * | 2005-07-13 | 2007-01-18 | Boston Scientific Scimed, Inc. | Snap fit sling anchor system and related methods |
US20070032695A1 (en) * | 2005-08-03 | 2007-02-08 | Boston Scientific Scimed, Inc. | Systems, devices and methods relating to a shape resilient sling-like support for treating urinary incontinence |
US20070038017A1 (en) * | 2005-08-11 | 2007-02-15 | Boston Scientific Scimed, Inc. | Tubular implantable sling and related delivery systems, methods and devices |
US20070123746A1 (en) * | 2005-11-16 | 2007-05-31 | Boston Scientific Scimed, Inc. | Devices for minimally invasive pelvic surgery |
US20080287731A1 (en) * | 2007-05-15 | 2008-11-20 | Generic Medical Devices, Inc. | Needle instruments and implantable sling assembly; kits comprising these components; and methods for use |
US20090216075A1 (en) * | 2008-02-21 | 2009-08-27 | Bell Stephen G | Methods and Apparatus for Treating Pelvic Floor Prolapse |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7407480B2 (en) * | 2001-07-27 | 2008-08-05 | Ams Research Corporation | Method and apparatus for correction of urinary and gynecological pathologies, including treatment of incontinence cystocele |
BR0308172A (en) * | 2002-03-01 | 2005-01-04 | Ethicon Inc | Method and apparatus for the treatment of pelvic organ prolapse in female patients |
US7494495B2 (en) * | 2003-03-28 | 2009-02-24 | Coloplast A/S | Method and implant for curing cystocele |
US7351197B2 (en) * | 2004-05-07 | 2008-04-01 | Ams Research Corporation | Method and apparatus for cystocele repair |
WO2006108045A2 (en) * | 2005-04-05 | 2006-10-12 | Ans Research Corporation | Articles, devices, and methods for pelvic surgery |
-
2007
- 2007-10-03 WO PCT/US2007/021360 patent/WO2008042438A2/en active Application Filing
- 2007-10-03 US US11/906,969 patent/US20080082105A1/en not_active Abandoned
- 2007-10-03 EP EP07839265.1A patent/EP2097013B1/en not_active Not-in-force
-
2013
- 2013-03-25 US US13/850,150 patent/US9539078B2/en active Active
Patent Citations (78)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4373530A (en) * | 1980-04-04 | 1983-02-15 | Lisa Ann Kilejian | Surgical stitching instrument |
US5152749A (en) * | 1991-06-28 | 1992-10-06 | American Medical Systems, Inc. | Instrument placement apparatus |
US5334185A (en) * | 1991-06-28 | 1994-08-02 | Giesy Consultants, Inc. | End-to-end instrument placement apparatus |
US6056688A (en) * | 1991-12-03 | 2000-05-02 | Boston Scientific Technology, Inc. | Device and method for transvaginally suspending the bladder neck |
US5403328A (en) * | 1992-04-22 | 1995-04-04 | United States Surgical Corporation | Surgical apparatus and method for suturing body tissue |
US5540704A (en) * | 1992-09-04 | 1996-07-30 | Laurus Medical Corporation | Endoscopic suture system |
US5520703A (en) * | 1993-06-07 | 1996-05-28 | Essig; Mitchell N. | Laparoscopic deschamp and associated suturing technique |
US20010010008A1 (en) * | 1996-11-08 | 2001-07-26 | Gellman Barry N. | Protective sheath for transvaginal anchor implantation device |
US6319272B1 (en) * | 1996-11-08 | 2001-11-20 | Boston Scientific Corporation | Transvaginal anchor implantation device and method of use |
US5843099A (en) * | 1997-01-16 | 1998-12-01 | Bei Medical Systems, Inc. | Single system ligature carrier and tissue clamp for sacrospinous colpopexy |
US5954057A (en) * | 1997-02-12 | 1999-09-21 | Li Medical Technologies, Inc. | Soft tissue suspension clip, clip assembly, emplacement tool and method |
US20020055748A1 (en) * | 1997-02-13 | 2002-05-09 | Gellman Barry N. | Devices for minimally invasive pelvic surgery |
US6423080B1 (en) * | 1997-02-13 | 2002-07-23 | Scimed Life Systems, Inc. | Percutaneous and hiatal devices and methods for use in minimally invasive pelvic surgery |
US20040230207A1 (en) * | 1997-02-13 | 2004-11-18 | Scimed Life Systems, Inc. | Devices for minimally invasive pelvic surgery |
US5935138A (en) * | 1997-09-24 | 1999-08-10 | Ethicon, Inc. | Spiral needle for endoscopic surgery |
US6730110B1 (en) * | 1999-01-08 | 2004-05-04 | Ams Research Corporation | Tack device |
US6099538A (en) * | 1999-02-02 | 2000-08-08 | T.A.G. Medical Products | Set of surgical tools and surgical method for connecting soft bone parts to one another or to connective tissue |
US6475139B1 (en) * | 1999-06-09 | 2002-11-05 | Ethicon, Inc. | Visually-directed surgical instrument and method for treating female urinary incontinence |
US6273852B1 (en) * | 1999-06-09 | 2001-08-14 | Ethicon, Inc. | Surgical instrument and method for treating female urinary incontinence |
US7226407B2 (en) * | 1999-06-09 | 2007-06-05 | Ethicon, Inc. | Surgical instrument and method for treating female urinary incontinence |
US20020077526A1 (en) * | 1999-06-09 | 2002-06-20 | Kammerer Gene W. | Surgical instrument and method for treating female urinary incontinence |
US7121997B2 (en) * | 1999-06-09 | 2006-10-17 | Ethicon, Inc. | Surgical instrument and method for treating female urinary incontinence |
US20060058574A1 (en) * | 1999-06-09 | 2006-03-16 | Jorg Priewe | Method and apparatus for adjusting flexible areal polymer implants |
US20020188169A1 (en) * | 1999-06-09 | 2002-12-12 | Kammerer Gene W. | Surgical instrument and method for treating female urinary incontinence |
US20030045892A1 (en) * | 1999-10-22 | 2003-03-06 | George Kaladelfos | Surgical instrument |
US6494887B1 (en) * | 1999-10-22 | 2002-12-17 | George Kaladelfos | Surgical instrument |
US20010018549A1 (en) * | 2000-01-21 | 2001-08-30 | Victor Scetbon | Percutaneous device and method for treating urinary stress incontinence in women using a sub-urethral tape |
US7131943B2 (en) * | 2000-03-09 | 2006-11-07 | Ethicon, Inc. | Surgical instrument and method for treating organ prolapse conditions |
US6596001B2 (en) * | 2000-05-01 | 2003-07-22 | Ethicon, Inc. | Aiming device for surgical instrument and method for use for treating female urinary incontinence |
US20020068948A1 (en) * | 2000-05-01 | 2002-06-06 | Johan Stormby | Aiming device for surgical instrument and method for use for treating female urinary incontinence |
US20010053916A1 (en) * | 2000-06-05 | 2001-12-20 | Rioux Robert F. | Methods and devices for the treatment of urinary incontinence |
US20030004395A1 (en) * | 2000-10-05 | 2003-01-02 | Sofradim Production | Suburethral support assembly in treatment of female urinary stress incontinence |
US20030191360A1 (en) * | 2000-10-12 | 2003-10-09 | James Browning | Apparatus and method for treating female urinary incontinence |
US20020091298A1 (en) * | 2000-10-20 | 2002-07-11 | Susanne Landgrebe | System with a surgical needle and a handle |
US6638209B2 (en) * | 2000-10-20 | 2003-10-28 | Ethicon Gmbh | System with a surgical needle and a handle |
US20050197525A1 (en) * | 2000-11-15 | 2005-09-08 | Gellman Barry N. | Systems and methods for delivering a medical implant to an anatomical location in a patient |
US20020107430A1 (en) * | 2001-01-23 | 2002-08-08 | Neisz Johann J. | Implantable article and method |
US6612977B2 (en) * | 2001-01-23 | 2003-09-02 | American Medical Systems Inc. | Sling delivery system and method of use |
US20020151762A1 (en) * | 2001-01-23 | 2002-10-17 | Rocheleau Gary A. | Sling assembly with secure and convenient attachment |
US20020099259A1 (en) * | 2001-01-23 | 2002-07-25 | Anderson Kimberly A. | Surgical instrument and method |
US20020099258A1 (en) * | 2001-01-23 | 2002-07-25 | Staskin David R. | Sling delivery system and method of use |
US20050131393A1 (en) * | 2001-03-09 | 2005-06-16 | Scimed Life Systems, Inc. | Systems, methods and devices relating to delivery of medical implants |
US20050131392A1 (en) * | 2001-03-09 | 2005-06-16 | Scimed Life Systems, Inc. | Systems, methods and devices relating to delivery of medical implants |
US20040087970A1 (en) * | 2001-03-09 | 2004-05-06 | Chu Michael S.H. | Systems, methods and devices relating to delivery of medical implants |
US7235043B2 (en) * | 2001-03-09 | 2007-06-26 | Boston Scientific Scimed Inc. | System for implanting an implant and method thereof |
US20020156488A1 (en) * | 2001-03-09 | 2002-10-24 | Gellman Barry N. | System for implanting an implant and method thereof |
US20020161382A1 (en) * | 2001-03-29 | 2002-10-31 | Neisz Johann J. | Implant inserted without bone anchors |
US20060069301A1 (en) * | 2001-03-29 | 2006-03-30 | Ams Research Corporation | Implant inserted without bone anchors |
US6595911B2 (en) * | 2001-04-03 | 2003-07-22 | Lovuolo Michael | Method and device for anchor implantation and support of bodily structures |
US20030065246A1 (en) * | 2001-07-27 | 2003-04-03 | Inman Mona J. | Surgical instruments |
US20030078468A1 (en) * | 2001-10-22 | 2003-04-24 | Jeff Skiba | Biological vessel suspending assembly and systems and methods utilizing same |
US20040133217A1 (en) * | 2002-03-07 | 2004-07-08 | Ams Research Corporation | Handle and surgical article |
US6911003B2 (en) * | 2002-03-07 | 2005-06-28 | Ams Research Corporation | Transobturator surgical articles and methods |
US20050143618A1 (en) * | 2002-03-07 | 2005-06-30 | Anderson Kimberly A. | Transobturator surgical articles and methods |
US20060058578A1 (en) * | 2002-04-11 | 2006-03-16 | Gyne Ideas Limited | Apparatus and method for treating female urinary incontinence |
US7371245B2 (en) * | 2002-08-02 | 2008-05-13 | C R Bard, Inc | Transobturator introducer system for sling suspension system |
US20060015069A1 (en) * | 2002-08-02 | 2006-01-19 | C.R. Bard, Inc. | Transobturator introducer system for sling suspension system |
US20040144395A1 (en) * | 2002-08-02 | 2004-07-29 | Evans Douglas G | Self-anchoring sling and introducer system |
US7204802B2 (en) * | 2002-08-29 | 2007-04-17 | Universite De Liege | Surgical procedure for the treatment of female urinary incontinence: tension-free inside-out transobturator urethral suspension |
US20040097974A1 (en) * | 2002-08-29 | 2004-05-20 | Jean De Leval | Surgical procedure for the treatment of female urinary incontinence: tension-free inside-out transobturator urethral suspension |
US6808486B1 (en) * | 2002-12-03 | 2004-10-26 | Pat O'Donnell | Surgical instrument for treating female urinary stress incontinence |
US20040225181A1 (en) * | 2003-04-25 | 2004-11-11 | Scimed Life Systems, Inc. | Systems and methods for sling delivery and placement |
US20050075660A1 (en) * | 2003-10-03 | 2005-04-07 | Chu Michael S. H. | Systems and methods for delivering a medical implant to an anatomical location in a patient |
US20050177022A1 (en) * | 2003-11-17 | 2005-08-11 | Scimed Life Systems, Inc. | Systems and methods relating to associating a medical implant with a delivery device |
US20050277807A1 (en) * | 2004-05-06 | 2005-12-15 | Maclean Brian | Systems and methods for sling delivery and placement |
US20050256366A1 (en) * | 2004-05-06 | 2005-11-17 | Chu Michael S H | Systems and methods employing a push tube for delivering a urethral sling |
US20060089525A1 (en) * | 2004-06-14 | 2006-04-27 | Boston Scientific Scimed, Inc. | Systems, methods and devices relating to implantable supportive slings |
US20060052800A1 (en) * | 2004-09-03 | 2006-03-09 | Secant Medical, Llc | Surgical tool for incontinence sling implantation |
US20060089524A1 (en) * | 2004-10-25 | 2006-04-27 | Chu Michael S H | Systems and methods for sling delivery and placement |
US20060235262A1 (en) * | 2005-02-04 | 2006-10-19 | Arnal Kevin R | Needle design for male transobturator sling |
US20060217589A1 (en) * | 2005-03-22 | 2006-09-28 | Wan Shaw P | Pubovaginal sling implanter and procedure for the usage |
US20060229596A1 (en) * | 2005-04-06 | 2006-10-12 | Boston Scientific Scimed, Inc. | Systems, devices, and methods for treating pelvic floor disorders |
US20070015953A1 (en) * | 2005-07-13 | 2007-01-18 | Boston Scientific Scimed, Inc. | Snap fit sling anchor system and related methods |
US20070032695A1 (en) * | 2005-08-03 | 2007-02-08 | Boston Scientific Scimed, Inc. | Systems, devices and methods relating to a shape resilient sling-like support for treating urinary incontinence |
US20070038017A1 (en) * | 2005-08-11 | 2007-02-15 | Boston Scientific Scimed, Inc. | Tubular implantable sling and related delivery systems, methods and devices |
US20070123746A1 (en) * | 2005-11-16 | 2007-05-31 | Boston Scientific Scimed, Inc. | Devices for minimally invasive pelvic surgery |
US20080287731A1 (en) * | 2007-05-15 | 2008-11-20 | Generic Medical Devices, Inc. | Needle instruments and implantable sling assembly; kits comprising these components; and methods for use |
US20090216075A1 (en) * | 2008-02-21 | 2009-08-27 | Bell Stephen G | Methods and Apparatus for Treating Pelvic Floor Prolapse |
Cited By (34)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080177132A1 (en) * | 2006-11-06 | 2008-07-24 | Caldera Medical, Inc. | Implants And Procedures For Treatment Of Pelvic Floor Disorders |
US9149352B2 (en) | 2006-11-06 | 2015-10-06 | Caldera Medical, Inc. | Implants and procedures for treatment of pelvic floor disorders |
US8480558B2 (en) | 2006-11-06 | 2013-07-09 | Caldera Medical, Inc. | Implants and procedures for treatment of pelvic floor disorders |
US9554885B2 (en) | 2006-11-06 | 2017-01-31 | Caldera Medical, Inc. | Implants and procedures for treatment of pelvic floor disorders |
US10010394B2 (en) | 2007-09-21 | 2018-07-03 | Boston Scientific Scimed, Inc. | Pelvic floor treatments and related tools and implants |
US20100274074A1 (en) * | 2007-09-21 | 2010-10-28 | Khamis Chaouki A | Pelvic floor treatments and related tools and implants |
US8708885B2 (en) * | 2007-09-21 | 2014-04-29 | Ams Research Corporation | Pelvic floor treatments and related tools and implants |
US9333065B2 (en) | 2007-09-21 | 2016-05-10 | Astora Women's Health, Llc | Pelvic floor treatments and related tools and implants |
US9974639B2 (en) | 2007-12-28 | 2018-05-22 | Boston Scientific Scimed, Inc. | Devices and methods for treating pelvic floor dysfunctions |
US11207166B2 (en) | 2007-12-28 | 2021-12-28 | Boston Scientific Scimed, Inc. | Devices and methods for treating pelvic floor dysfunctions |
US10959823B2 (en) | 2009-01-05 | 2021-03-30 | Caldera Medical, Inc. | Implants and procedures for supporting anatomical structures for treating conditions such as pelvic organ prolapse |
US10136980B2 (en) | 2009-01-05 | 2018-11-27 | Caldera Medical, Inc. | Implants and procedures for supporting anatomical structures for treating conditions such as pelvic organ prolapse |
US20100191044A1 (en) * | 2009-01-05 | 2010-07-29 | Caldera Medical, Inc. | Implants And Procedures For Supporting Anatomical Structures For Treating Conditions Such As Incontinence |
US20100191045A1 (en) * | 2009-01-05 | 2010-07-29 | Caldera Medical,Inc. | Implants And Procedures For Supporting Anatomical Structures For Treating Conditions Such As Pelvic Organ Prolapse |
US20100191046A1 (en) * | 2009-01-05 | 2010-07-29 | Caldera Medical, Inc. | Implants And Procedures For Supporting Anatomical Structures |
US8758220B2 (en) | 2009-01-05 | 2014-06-24 | Caldera Medical, Inc. | Implants and procedures for supporting anatomical structures for treating conditions such as pelvic organ prolapse |
US9668845B2 (en) | 2009-04-17 | 2017-06-06 | Boston Scientific Scimed, Inc. | Delivery sleeve for pelvic floor implants |
US9125716B2 (en) * | 2009-04-17 | 2015-09-08 | Boston Scientific Scimed, Inc. | Delivery sleeve for pelvic floor implants |
US20100268018A1 (en) * | 2009-04-17 | 2010-10-21 | Boston Scientific Scimed, Inc. | Delivery sleeve for pelvic floor implants |
US8545520B2 (en) | 2009-07-22 | 2013-10-01 | Coloplast A/S | Tissue suturing method |
US8282657B2 (en) | 2009-07-22 | 2012-10-09 | Coloplast A/S | Suturing system and assembly |
US20110077456A1 (en) * | 2009-09-30 | 2011-03-31 | Bruce Drummond | Prolapse repair device and methods of use |
US8257366B2 (en) | 2010-02-08 | 2012-09-04 | Coloplast A/S | Digital suture fixation system |
US20110196386A1 (en) * | 2010-02-08 | 2011-08-11 | Coloplast A/S | Digital suture fixation system |
US20110196389A1 (en) * | 2010-02-09 | 2011-08-11 | Coloplast A/S | Digital suture fixation system |
US20120029488A1 (en) * | 2010-07-29 | 2012-02-02 | Boston Scientific Scimed, Inc. | Adjustable device for delivering implants and methods of delivering implants |
US10085742B2 (en) * | 2010-07-29 | 2018-10-02 | Boston Scientific Scimed, Inc. | Adjustable device for delivering implants and methods of delivering implants |
US8992550B2 (en) | 2011-07-20 | 2015-03-31 | Coloplast A/S | Suture system with capsule eyelet providing multiple suture tissue fixation |
US8623033B2 (en) | 2011-07-20 | 2014-01-07 | Coloplast A/S | Suture system with capsule eyelet providing multiple suture tissue fixation |
US9289194B2 (en) * | 2012-01-06 | 2016-03-22 | Jai Singh | Insert and insert system for a laparoscopic instrument |
US20130178865A1 (en) * | 2012-01-06 | 2013-07-11 | Jai Singh | Insert and insert system for a laparoscopic instrument |
US10398472B2 (en) | 2016-06-29 | 2019-09-03 | William H. Long | Subaxillary traction device to address shoulder dystocia during childbirth |
WO2018005467A1 (en) * | 2016-06-29 | 2018-01-04 | Long William H | Subaxillary traction device to address shoulder dystocia during childbirth |
CN111956284A (en) * | 2020-08-17 | 2020-11-20 | 王中显 | Sacrospinous ligament suturing device |
Also Published As
Publication number | Publication date |
---|---|
US20130225919A1 (en) | 2013-08-29 |
WO2008042438A2 (en) | 2008-04-10 |
US9539078B2 (en) | 2017-01-10 |
WO2008042438A8 (en) | 2008-09-04 |
EP2097013A2 (en) | 2009-09-09 |
EP2097013B1 (en) | 2017-03-29 |
WO2008042438A3 (en) | 2008-07-17 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US10251738B2 (en) | Pelvic floor repair system | |
US9539078B2 (en) | Systems, devices and methods for treating pelvic floor disorders | |
US9308071B2 (en) | Systems, devices and methods for delivering an implant | |
US9655706B2 (en) | Reinforced mesh for retropubic implants | |
US9107659B2 (en) | Snap fit sling anchor system and related methods | |
US7981023B2 (en) | Elastic sling system and related methods | |
US8016741B2 (en) | Systems, devices, and methods for sub-urethral support | |
US8870745B2 (en) | Pelvic floor repair implants | |
US9248010B2 (en) | Tension-adjustable surgical sling assembly |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: BOSTON SCIENTIFIC SCIMED, INC., MINNESOTA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CHU, MICHAEL S. H.;REEL/FRAME:019981/0534 Effective date: 20070919 |
|
AS | Assignment |
Owner name: BOSTON SCIENTIFIC, INC., MINNESOTA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CHU, MICHAEL S.H.;REEL/FRAME:020761/0634 Effective date: 20070919 Owner name: BOSTON SCIENTIFIC SCIMED, INC., MINNESOTA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CHU, MICHAEL S.H.;REEL/FRAME:020761/0634 Effective date: 20070919 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |