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Publication numberUS20070060788 A1
Publication typeApplication
Application numberUS 11/600,491
Publication dateMar 15, 2007
Filing dateNov 16, 2006
Priority dateNov 15, 2000
Also published asUS6689047, US7014607, US8025619, US8845511, US20020058959, US20040106846, US20050197525, US20120016183, WO2002039914A1
Publication number11600491, 600491, US 2007/0060788 A1, US 2007/060788 A1, US 20070060788 A1, US 20070060788A1, US 2007060788 A1, US 2007060788A1, US-A1-20070060788, US-A1-2007060788, US2007/0060788A1, US2007/060788A1, US20070060788 A1, US20070060788A1, US2007060788 A1, US2007060788A1
InventorsBarry Gellman
Original AssigneeBoston Scientific Scimed Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Systems and methods for delivering a medical implant to an anatomical location in a patient
US 20070060788 A1
Abstract
A surgical device for use in a minimally invasive procedure to treat urinary incontinence can include a dilator coupled to a curved needle at one end and a sling at the opposite end. Urinary incontinence can be treated minimally invasively. One treatment includes positioning the sling on an anterior portion of the urethra to provide proper coaptation to the urethra.
Images(4)
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Claims(19)
1-18. (canceled)
19. A sling assembly for treating urinary incontinence comprising:
an implantable surgical sling covered at least partially by a protective pouch; and
a dilator located at an end of the pouch for enlarging an opening in the body of a patient.
20. The sling assembly of claim 19, wherein the dilator has a tapered leading edge.
21. The sling assembly of claim 19, wherein the dilator is substantially cylindrical and tapered at one end.
22. The sling assembly of claim 19, wherein an outer circumference of the dilator increases from a first end of the dilator toward a second end of the dilator.
23. The sling assembly of claim 19, wherein a width of the dilator increases from a first end of the dilator toward a second end of the dilator.
24. The sling assembly of claim of claim 23, wherein the dilator is about 0.5 centimeters to about 4 centimeters in width at the second end of the dilator.
25. The sling assembly of claim 19, wherein a width of the dilator is larger than a width of the sling.
26. The sling assembly of claim 19, wherein the sling comprises a material selected from a natural material, a synthetic material, and a combination of a natural material and a synthetic material.
27. The sling assembly of claim 19, wherein the sling is about 1 centimeter to about 3 centimeters in width.
28. The sling assembly of claim 19, wherein the dilator attaches to the pouch.
29. The sling assembly of claim 19, wherein the pouch releasably attaches to the sling.
30. The sling assembly of claim 19, wherein the pouch encapsulates the sling.
31. The sling assembly of claim 19, wherein the pouch is made of a low friction material.
32. The sling assembly of claim 19, wherein the pouch is substantially flat.
33. The sling assembly of claim 19, wherein the pouch is translucent.
34. The sling assembly of claim 19, wherein the pouch has one or more perforations.
35. The sling assembly of claim 19, wherein the pouch is made from a polyvinyl, a polyester, polyethylene terephthalate (PET), polyethylene (PE), ethylene vinyl acetate (EVA), or combinations thereof.
36. The sling assembly of claim 19, wherein the pouch is porous.
Description
    CROSS-REFERENCE TO RELATED APPLICATIONS
  • [0001]
    This application is a continuation application of U.S. patent application Ser. No. 10/723,334, filed on Nov. 26, 2003, which is a continuation of U.S. patent application Ser. No. 09/992,359, now issued U.S. Pat. No. 6,689,047, filed on Nov. 14, 2001, which claims benefit of and priority to U.S. provisional patent application Ser. No. 60/248,808, filed on Nov. 15, 2000, the entire disclosures of which are incorporated by reference herein.
  • TECHNICAL FIELD
  • [0002]
    The present invention relates to devices and methods for treating urinary incontinence, such as urinary incontinence in women resulting from intrinsic sphincter deficiency.
  • BACKGROUND INFORMATION
  • [0003]
    Urinary incontinence is a widespread problem throughout the world. Urinary incontinence affects people of all ages and can severely impact a patient both physiologically and psychologically.
  • [0004]
    One form of urinary incontinence suffered by women is intrinsic sphincter deficiency (ISD), a condition in which the valve of the urethral sphincter does not function properly, thus preventing proper coaptation of the urethra. Without proper coaptation, a person is unable to control urinary leakage. ISD can arise from loss of urethral vasculature, thinning of urethral mucosa, loss of the urethral connective tissue elements, neurologic compromise of the sympathetic smooth muscle, or compromise of the external striated sphincter.
  • [0005]
    Another form of urinary incontinence is known as bladder neck hypermobility. Bladder neck hypermobility can arise from loss of support by the pelvic floor and loss of suspension by the pelvic connective tissue in ligaments and fascia. In this condition, the bladder neck and proximal urethra descend in response to increases in intra-abdominal pressure, resulting in uncontrollable urinary leakage.
  • [0006]
    Common approaches to treating urinary incontinence in women require invasive surgical procedures either through the vaginal wall or the abdominal wall. These surgical procedures focus on elevating the urethrovesical junction by introducing a sling that passes to the posterior side of the urethra and suspending the urethra from an anatomical structure located anterior to the urethra, for example, the abdominal fascia, the pubic bone, or the Cooper's ligament. Surgical treatments of urinary incontinence that use slings typically involve placing the sling under the urethra to provide suburethral support. Slings of this type simultaneously compress and suspend the urethra to treat urinary incontinence. One disadvantage of these procedures is the invasive nature of these procedures. Another disadvantage is that weight gain or loss can affect the suspension of the urethra causing it to become too tight or too loose. Still another disadvantage is that some types of slings may shrink with age and may cause difficulties with voiding. Other invasive surgical approaches to treating urinary incontinence include the use of vaginal wall slings and/or artificial urinary sphincters.
  • [0007]
    Periurethral injection (PI) of biocompatible bulk-enhancing agents, another approach to treating urinary incontinence, has the advantage of being a less invasive form of treatment and, thus, can be performed on an outpatient basis. PI uses bulk-enhancing agents, such as Teflon® (DuPont), autologous fat, and collagen, to increase pressure on the urethra and reduce the size of the urethral lumen, providing additional resistance to the flow of urine. Such injections may be accomplished either transurethrally or periurethrally. Typically, however, repeat treatments of PI are required because the bulk-enhancing agent can be absorbed by the body or translocated from the site of injection. Another drawback to PI is that accidental over-bulking may result in undesirable urinary retention requiring catheterization to void until the injectant is absorbed by the body.
  • SUMMARY OF THE INVENTION
  • [0008]
    The present invention relates to a treatment for urinary incontinence without drawbacks associated with more invasive surgeries or PI. The invention generally involves coapting a urethra externally between a sling and a vaginal wall. The term “urethra,” as used herein, generally includes the bladder neck. Because of the minimally invasive nature of the invention, a procedure according to the invention can be performed in conjunction with other transvaginal procedures. In addition, such a procedure can quickly and easily be reversed as the sling may be held in place by removable securing devices such as sutures or surgical staples.
  • [0009]
    In one aspect, the invention features a surgical device for treating urinary incontinence that includes a curved needle, a dilator, and a sling. A distal end of the dilator is coupled to a proximal end of the curved needle, and a distal end of the sling is coupled to a proximal end of the dilator.
  • [0010]
    In some embodiments, the curved needle includes a curvature sufficient to allow the needle to enter the body from the vaginal cavity and through the vaginal wall, pass to one side of the urethra, continue over an anterior side of the urethra, and exit the body on the other side of the urethra.
  • [0011]
    The dilator generally can be any shape in which the distal end is tapered and the proximal end can create an opening to accommodate a sling as it follows the dilator into the body. In some embodiments, the dilator can be substantially flat and triangular in shape. In other embodiments, the dilator can be substantially rectangular and tapered at the distal end. The dilator can be made from one or more biocompatible materials such as a plastic or metal. The dilator can also include markings to indicate the location of the sling within the body.
  • [0012]
    The sling can be made of one or more biocompatible materials selected from the group consisting of a natural material, a synthetic material, or a combination of a natural material and a synthetic material. The sling can be about 0.5 cm to about 4 cm in width. In a particular embodiment, the sling is about 1 to about 3 cm in width. In another particular embodiment, the sling is about 1.5 to about 2.5 cm in width.
  • [0013]
    In some embodiments, a tether couples the curved needle to the dilator. Examples of the form the tether may take includes a wire, a suture, and a portion of the sling.
  • [0014]
    In some embodiments, a first portion of the sling can be smaller in width than a middle portion of the sling. In a particular embodiment, the first portion of the sling can couple the sling to the dilator. In another particular embodiment, the first portion of the sling can couple the dilator to the needle.
  • [0015]
    In some embodiments, a pouch can be fixedly attached to the dilator and releasably attached to the sling. In other embodiments, the surgical device can include a stiffener to maintain the sling in a generally planar orientation as it enters the body.
  • [0016]
    In another aspect, the invention features a surgical device that includes a sling, a first tether with a proximal end coupled to a distal end of the sling, a second tether with a distal end coupled to a proximal end of the sling, a curved needle coupled to a distal end of the first tether, and a dilator disposed along the first tether between the curved needle and the distal end of the sling.
  • [0017]
    In yet another aspect, the invention features a method of treating urinary incontinence. The method includes introducing a sling into a body and positioning the sling on an anterior side of the urethra to coapt the urethra against the vaginal wall. The sling can be introduced into the body via the vaginal cavity and through the vaginal wall. In some embodiments, the sling is positioned to surround less than 360° of the circumference of the urethra. In some embodiments, the sling is positioned to surround approximately 180°of the circumference of the urethra on an anterior side of the urethra. In other embodiments, the sling is positioned to surround approximately 90° to approximately 180° of the urethra on the anterior side of the urethra.
  • [0018]
    In some embodiments, a surgical device according the invention is introduced into the body via the vaginal cavity and through the vaginal wall to pass to one side of the urethra, and then pass about the anterior side of the urethra, and to exit the body on the other side of the urethra into the vaginal cavity. The surgical device can include a curved needle, a dilator, and a sling, and the sling can be positioned in the body to coapt the urethra to an anterior portion of the vaginal wall in the body.
  • [0019]
    In some embodiments, the anterior of the urethra is separated from surrounding tissue, for example, the bladder. The separating step can be performed, for example, by using hydrodissection or balloon dissection.
  • [0020]
    In still another aspect, the invention features a method of treating urinary incontinence. The method includes introducing a surgical device into a body via the vaginal cavity. The surgical device can comprise a sling, including a distal end and a proximal end, and a first tether, including a distal end and a proximal end, wherein the proximal end of the tether is coupled to a distal end of the sling. The device can also include a second tether, including a distal end and a proximal end, wherein the distal end of the second tether is coupled to a proximal end of the sling. The device can also include a curved needle coupled to the distal end of the first tether and a dilator disposed along the first tether between the curved needle and the distal end of the sling. The curved needle is passed into the body via the vaginal cavity, through the vaginal wall to one side of the urethra, over an anterior portion of the urethra, and out of the body on the other side of the urethra into the vaginal cavity, creating a path for the first tether, the dilator, the sling, and the second tether to follow. The dilator is advanced along the path to position the sling about the urethra, leaving at least a portion of the second tether in the vaginal cavity. The dilator and at least a portion of the first tether exits the body into the vaginal cavity, leaving the sling in place about the anterior portion of the urethra to coapt the urethra to the anterior portion of the vaginal wall. The first tether and second tether are secured to an interior wall of the vaginal cavity.
  • [0021]
    The method can also include separating the anterior portion of the urethra from the surrounding tissue to create a pocket or opening to accommodate the sling.
  • [0022]
    These and other objects, along with advantages and features of the invention disclosed herein, will be made more apparent from the description, drawings, and claims that follow.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0023]
    In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead being placed generally upon illustrating the principles of the invention.
  • [0024]
    FIG. 1 shows a surgical device according to one embodiment of the invention.
  • [0025]
    FIG. 2 shows a surgical device according to one embodiment of the invention.
  • [0026]
    FIG. 3 shows a transverse cross-sectional view of the surgical device of FIG. 2 along section 3-3.
  • [0027]
    FIG. 4 shows a sling according to one embodiment of the invention.
  • [0028]
    FIG. 5 shows a sling according to one embodiment of the invention.
  • [0029]
    FIG. 6 shows a surgical device according to one embodiment of the invention.
  • [0030]
    FIGS. 7A-C show three exemplary embodiments of transverse cross-sectional views of the surgical device of FIG. 6 along section 7A, 7B, 7C-7A, 7B, 7C.
  • [0031]
    FIG. 8 shows a surgical device according to one embodiment of the invention.
  • [0032]
    FIG. 9 is a schematic diagram of a step in a method according to one embodiment of the invention.
  • [0033]
    FIG. 10 is a schematic diagram of a step in a method according to one embodiment of the invention.
  • [0034]
    FIG. 11 is a schematic diagram of a step in a method according to one embodiment of the invention.
  • DESCRIPTION
  • [0035]
    FIG. 1 depicts a surgical device 10 according to one embodiment of the present invention. FIG. 1 shows a curved needle 20, a first tether 30, a dilator 40, a sling 50, and a second tether 60.
  • [0036]
    The curved needle 20 can be any curved needle used to guide the rest of the surgical device 10 around a bladder neck. The needle 20 can be a curved solid needle, a hollow needle, or a channeled needle. The proximal end of the needle 24 can have an eyelet or other attachment structure. The first tether 30 is shown to couple the dilator 40 to the curved needle 20. The tether 30 can be coupled to the needle 20 by any means including, but not limited to, tying, gluing, looping, crimping, and bonding.
  • [0037]
    The curvature of the needle 20 should be sufficient to pass around a urethra 104 from a vaginal cavity 102, as shown in FIG. 9. The needle 20 may be of any size and/or type. For example, the needle 20 may be a ˝ circle or a ⅜ circle needle. The needle 20 may be of any point configuration such as a cutting point or a reverse cutting point. The size of the needle 20 may also range from 12 mm-25 mm. Examples of needles 20 include, but are not limited to, Ethicon PC-12 and PS-5. (Ethicon, Inc., Somerville, N.J.)
  • [0038]
    The first tether 30 and the second tether 60 can be formed from a suture, a wire, a portion of the sling 50, or any other material that is strong enough to resist breaking as the surgical device 10 is passed through the body. The tethers 30, 60 may be attached to the sling 50 in any number of ways known in the art such as tying, suturing, bonding, or molding. The tethers 30, 60 can also be used to secure the sling 50 in place once it is disposed around the urethra 104. The sling 50 is secured by the tethers 30, 60 to the interior portion of the vaginal wall. Typically, the tethers 30, 60 remaining in the vaginal wall will eventually be covered with endothelial tissue. In some embodiments, the tether 30, 60 is a suture. The suture can be a non-absorbable suture such as a polyester, for example Dacron@ polyester (DuPont, Wilmington, Del.), an expanded polytetrafluoroethylene (EPTFE), such as Gore-Tex® (W.L. Gore & Associates, Inc., Newark, Del.), a polypropylene, or a braided silk. Other suitable materials that can be used as a suture will be apparent to those skilled in the art.
  • [0039]
    The dilator 40 can be made of a semi-rigid plastic material. Examples of such materials include, but are not limited to, polyethylene terephthalate (PET), polyethylene (PE), or ethylene vinyl acetate (EVA). The dilator 40 is sufficiently rigid to push through the tissue of the body and create an opening for the sling 50, but also sufficiently flexible to curve axially around the urethra 104, following the path of the curved needle 20, as shown in FIGS. 9 and 10.
  • [0040]
    The distal end 42 of the dilator 40 can be substantially similar in size to the proximal end 24 of the curved needle 20. From the distal end 42 of the dilator 40, the dilator 40 can expand in a planar direction, a cylindrical direction (i.e., increasing circumference), or combination of both a planar direction and a cylindrical direction. For example, if the dilator 40 expands in a planar direction, the resultant dilator 40 is substantially flat and triangular in shape. The dilator 40 preferably expands until it reaches a size not less than the width of the sling 50, to ensure that the opening created by the dilator 40 will accommodate the width of the sling 50. The dilator 40 can terminate at a maximum width, whereby the passage of the dilator 40 through the body creates an opening sufficiently wide to allow the sling 50 to pass through the body. The length of the dilator 40 can be sufficient to allow the dilator 40 to be grasped with forceps and pulled and/or pushed through the body, if necessary.
  • [0041]
    Alternatively, as shown in FIGS. 2 and 3, the dilator 140 can be extended distally to overlap with or partially enclose the sling 150. In embodiments where the dilator 140 is further extended, the proximal portion of the dilator 140 can also be used as a stiffener 146 to prevent the sling 150 from rolling or curling. Alternatively, the stiffener 146 may be a separate element from the dilator 140. The stiffener 146 provides rigidity and prevents distortion of the sling 150 during passage through the patient's body, as well as permitting the dilator 140 to dilate or cut an opening in the patient's body as it passes through the body in the path created by the curved needle 120.
  • [0042]
    In some embodiments, the curved needle 120 and dilator 140 may be a single unit, for example a curved blade. This single unit may include a sharp point at the distal end to create an incision from which the blade flares out, curving axially along its length, to a maximum width at the proximal end.
  • [0043]
    The dilator 140 and/or the stiffener 146 may also provide a bending effect that permits the sling 150 to follow an axial bend along its length. Finally, the dilator 140 and the stiffener 146 can reduce damage to the sling 150 during handling.
  • [0044]
    The stiffener 146 may be made of the same material or a different material than the dilator 140. The stiffener 146 may be made of any of a variety of materials compatible with the above-described considerations including, but not limited to, polyethylene, polypropylene, and acrylic. The stiffener 146 may provide approximately 1 cm radius of bending to 2 cm radius of bending. The stiffener 146 may be porous to permit a solution to access the sling 150 during a soak with a solution. Examples of such materials include, but are not limited to, polyethylene and polyethylene terephthalate made porous by methods well known in the art. Other suitable materials will be apparent to those skilled in the art. The dilator 140 and the stiffener 146 may be adapted to releasably engage the sling 150.
  • [0045]
    The dilator 140 may also be marked to indicate the position of the sling 150 in the body. The marking(s) 148 are placed along at least a portion of the length of the dilator 140. In this manner, as the surgical device 110 is passed through the body, the user can determine the location of the sling 150 in the body by referring to the markings 148 on the dilator 140.
  • [0046]
    Referring to FIG. 4, the sling 250 can be made of any biologically acceptable material for implantation into a body. The material can be a supple material that is sterile, or can be effectively sterilized, and is otherwise biologically acceptable for implantation into a body. For example, the material can be a synthetic polymer, a processed animal tissue, or a combination of synthetic polymers and animal tissue. The term “processed animal tissue” means tissue from an animal source, wherein antigenic sites within the tissue are bound, destroyed, or removed so as to reduce the antigenicity of the tissue. Slings are also described in U.S. Pat. No. 6,042,534 issued Mar. 28, 2000, the entire disclosure of which is incorporated herein by reference.
  • [0047]
    Where the material is processed animal tissue, the tissue can include, among others, porcine tissue, bovine tissue, ovine tissue, equine tissue, and human tissue. Human tissue can be obtained from human cadavers or living donors. Processed animal tissue can be made from tendons, ligaments, and fibro-serous tissues. Where the processed animal tissue is made from fibro-serous tissues, the tissue can be from the dura mater, pericardium, peritoneum, tunica vaginalis, and dermas. Typically, these tissues are cleansed, dehydrated, cross-linked, and sterilized. Processed animal tissues are preferably chemically cross-linked animal tissues prepared by any of a number of methods that are well known in the art. However, any method of reducing or removing the antigenic sites within the tissue can be used to prepare the animal tissue. Examples of such methods include, but are not limited to, freeze-drying, protease treating, and acid treating the tissue to remove the antigenic sites. Tissues from a patient's own body will not need to undergo these processing steps.
  • [0048]
    Synthetic polymers include polymers such as polytetrafluoroethylene (PTFE), such as Teflon® (DuPont, Wilmington, Del.); expanded polytetrafluoroethylene (EPTFE), such as Gore-Tex® (W.L. Gore & Associates, Inc., Newark, Del.), polyesters or polyethylene terephthalates, such as Dacron@ polyester (DuPont, Wilmington, Del.), and silicone elastomers. Other suitable materials will be apparent to those skilled in the art.
  • [0049]
    Combinations of synthetic polymers and processed animal tissues can also be used in slings 50, 150, 250 of the present invention. These combinations may include spliced strips having a combination of parts, including parts made of synthetic polymers and of processed animal tissues. Such combinations preferably include animal tissue that is treated so as to crosslink the collagen or otherwise render impotent the commonly antigenic fibers in the animal tissue. An example of such a combination material is collagen-coated ultrafine polyester mesh (CUFP) of the type disclosed by T. Okoski et al., ASAIO Trans., 1989, p. 391.
  • [0050]
    The sling 250, as shown in FIG. 4, includes an elongated strip of material having variable dimensions, including a thickness, a width 256 and a length 257. The dimensions of the sling 250 can be varied depending on the use of the sling 250. In some embodiments, the length 257 can be greater than the width 256. In other embodiments, the length 257 can be substantially the same or smaller than the width 256. It is desirable for the width 256 to be at least sufficient to comfortably coapt the urethra to the vaginal wall. In one embodiment, the width 256 may be greater than about 0.5 cm, but less than about 4 cm. Other widths include, but are not limited to, 1-3 cm, 1.5-2.5 cm, and 2 cm. The length 257 should be sufficient to encompass at least a portion of the urethra and provide the urethra with sufficient pressure for proper coaptation. Proper coaptation may be accomplished with a length sufficient to encompass the urethra from at least 90° to about 180° of the circumference of the urethra.
  • [0051]
    Alternatively, the sling 350, as shown in FIG. 5, may be made sufficiently long to be used to secure the sling 350 to the interior vaginal wall without the use of additional sutures. The sling 350 can include a first portion 351, a middle portion 352, and a second portion 353. In this embodiment, the first portion 351 and the second portion 353 can be used as tethers. The middle portion 352 is that area of the sling 350 that is disposed adjacent the urethra. The first portion 351 and second portion 353 can also be used to secure the sling 350 in place. The width of the sling 350 may be the same for the first portion 351, middle portion 352, and second portion 353. However, the width may be different for one or all three portions 351, 352, 353. In FIG. 5, the width of the middle portion 352 is greater than the first portion 351 or second portion 353.
  • [0052]
    The sling 350 may be a single piece or be made of a plurality of pieces that are joined by any of a number of well known attachment methods, such as securing the attached piece or pieces to the other portions of the sling 350 using sutures 354 as shown in FIG. 5. Other methods include, but are not limited to, gluing, bonding, and heat sealing.
  • [0053]
    FIG. 6 depicts another embodiment of the surgical device 410. This embodiment includes a pouch 470. The pouch 470 can be used to permit the sling 450 to be handled without damage, maintain a barrier preventing microorganisms from contacting the sling 450, provide handling flexibility, and ensure that the sling 450 is introduced into the opening or pocket in the patient's body in the desired orientation. When the pouch 470 is made of a low friction material, the pouch 470 may also increase the ease of passage of the sling 450 through the opening created by the dilator 440. The pouch 470 may be made of a variety of materials. Examples of such materials include, but are not limited to, polyvinyls and polyesters such as, polyethylene terephthalate (PET), polyethylene (PE), and ethylene vinyl acetate (EVA). Pouches are also described in copending U.S. patent application Ser. No. 09/023,965 filed Feb. 13, 1998, the entire disclosure of which is incorporated herein by reference.
  • [0054]
    The pouch 470 can be flat to facilitate delivery of the sling 450 in a flat orientation. However, the pouch 470 may also be conical, or rolled conical, and be provided with means for flattening the sling 450 after delivery. Alternatively, the pouch 470 may be used in conjunction with a sling 450 made from a material that adopts a flat configuration after being delivered into the body.
  • [0055]
    The pouch 470 can be clear or translucent to permit visualization of the sling 450 within. The pouch 470 can also be made of a porous material such as polyethylene, polyethylene terephthalate, or vinyl made porous by methods well known in the art. Other suitable materials will be apparent to those skilled in the art. The pouch 470 can be adapted to receive a dilator 440 and a sling 450. The surgical device 410 may also include a stiffener 446 as shown in any one of FIGS. 7A-C. FIGS. 7A-C depict three variations of transverse cross-sections of the surgical device 410 along section 7A, 713, 7C-7A, 7B, 7C of FIG. 6. The stiffener 446 and sling 450 may be housed in the pouch 470 (FIG. 7A). The sling 450 may be housed in the stiffener 446 that is housed in the pouch 470 (FIG. 7B). The sling 450 may be housed in the pouch 470; however, the stiffener 446 is adjacent but not housed in the pouch 470 (FIG. 7C). The length of the pouch 470 may be varied depending upon the length of the sling 450. Alternatively, the pouch 470 may be greater or lesser in length than the sling 450. The pouch 470 is adapted to releasably engage the sling 450.
  • [0056]
    It is desirable that the sling introduced into the opening in the patient's body be sterile. In this regard, FIG. 8 depicts a further embodiment of the surgical device 510, in which the pouch 570 has pores 572 that can permit rehydration of a sling 550 and/or antibiotic or saline soaks of the sling 550 in the pouch 570 prior to introducing the sling 550 into the patient. The pores 572 may be of any size sufficient to permit wetting of the sling 550. The pores 572 may range in size from about 100 microns to about 0.25 inches. Preferably, the pore size ranges from about 0.01 inches to about 0.15 inches. In one preferred embodiment, the pouch 570 is made of vinyl having a pore size of about 0.125 inches.
  • [0057]
    In another aspect, the invention provides methods for introducing a sling from the vaginal cavity to coapt the urethra to the vaginal wall. One method described below includes the use of a surgical device, as contemplated in the present invention, to coapt the urethra 104, as shown in FIG. 11. While the procedure is described with particular reference to the surgical device 410 of FIG. 6, those skilled in the art will appreciate that any of the surgical devices contemplated herein may be used in this procedure.
  • [0058]
    In one method according to the present invention, a curved needle 420 such as a Mayo needle is advanced from the vaginal cavity 102, through the anterior portion 108 of the vaginal wall, to pass to one side of the urethra 104. The needle 420 is advanced around the urethra 104 to the other side of the urethra 104 until the needle 420 emerges from the anterior portion of the vaginal wall 108 back into the vaginal cavity 102.
  • [0059]
    Attached to the needle 420 is a dilator 440 that enlarges the puncture site created by the needle 420. The dilator 440 can increase the area of the puncture site until the opening is sufficiently large to accommodate the sling 450. The dilator 440 is passed about the urethra 104 until it emerges through the anterior vaginal wall 108. The dilator 440 may contain markings 448 along its length to inform the user of the position of the sling 450 in the body. The length of the dilator 440 can permit grasping with a forceps and/or enable pushing the dilator 440 while maintaining tension on the first tether 430 to guide it about the urethra 104. As the needle 420 and dilator 440 are passed through the body, the needle 420 and dilator 440 create a path along the longitudinal axis of the urethra to 104 for the sling 450 to follow.
  • [0060]
    As the dilator 440 is withdrawn from the body into the vaginal cavity 102, the appropriate marking(s) 448 can be used to alert the user to secure the second tether 460 to the anterior portion of the vaginal wall 108 to prevent further passage of the sling 450 and maintain its position above the anterior portion of the urethra 104. The dilator 440 is then withdrawn from the body along with the pouch 470. The sling 450 is thereby disposed axially to the urethra 104. The first tether 430 is used to secure the sling 450 with enough tension to pull the urethra 104 against the vaginal wall 108 to thereby provide proper coaptation to the urethra 104.
  • [0061]
    Alternatively, the needle 420, the dilator 440, and pouch 470 may be removed from the body without first securing the second tether 460. In this method, the physician will see two incisions (one on either side of the urethra 104) on the vaginal wall 108 and each incision having a tether 430, 460 emerging from the incision. When the tether 430, 460 is a suture, the tether 430, 460 can be attached to a Mayo needle and secured to the anterior portion of the vaginal wall 108 approximately centering the sling 450 over the urethra 104. The Mayo needle can then be attached to the other tether 430, 460 to repeat the process. A cystoscope can be placed within the urethra 104 to view the interior of the urethra 104. Under visualization, the second suture 460 can be tightened to coapt the urethra 104 and then secured to the anterior portion of the vaginal wall 108.
  • [0062]
    A device other than sutures may secure the sling 450. The securing device can include, but is not limited to, a fastener, a clip, a staple, or a clamp. The tethers 430, 460 may also be fastened to each other to secure the sling 450. In sutureless embodiments, the sling 450 may be attached directly to the anterior portion of the vaginal wall 108 by a securing device.
  • [0063]
    In another method according to the invention, an opening or pocket around the urethra 104 is created to receive the sling 450. This opening or pocket can be created prior to passing the surgical device 410 through the body. The opening or pocket may be created in a variety of ways. For example, the opening may be created by hydrodissection in which a bolus of saline or other sterile solution can be injected through the anterior portion of the vaginal wall 108 targeting the tissue that surrounds the urethra 104. For this procedure, the opening or pocket to be created is made to the anterior portion of the urethra 104. An advantage of hydrodissection is that the urethra 104 is separated from the surrounding tissue along tissue planes to create an opening or pocket to receive the sling 450.
  • [0064]
    Typically, in hydrodissection procedures the volume of saline injected into the tissue is too large to be readily absorbed and, therefore, the tissue must separate to accommodate the saline bolus. Preferably, the volume of saline introduced into the tissue is from about 4 cc to about 10 cc. More preferably, the volume of saline is from about 4 cc to about 5 cc. Multiple injections may be required to create an opening or pocket of sufficient size.
  • [0065]
    In an alternative approach, the opening or pocket can be created by balloon dissection in which a non-inflated, expandable balloon is introduced into the tissue between the anterior portion of the urethra 104 and the surrounding tissue. When the balloon is expanded, the surrounding tissue is dilated or torn, generating an opening or pocket of sufficient size to receive the sling 450.
  • [0066]
    In yet another approach, the opening or pocket can be created by dissecting the tissue between the anterior portion of the urethra 104 and the surrounding tissue with blunt dissectors and/or sharp cutters to accommodate the sling 450.
  • [0067]
    Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention as claimed. Accordingly, the invention is to be defined not by the preceding illustrative description but instead by the spirit and scope of the following claims.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2671444 *Dec 8, 1951Mar 9, 1954Pease Jr Benjamin FNonmetallic mesh surgical insert for hernia repair
US3124136 *Jan 3, 1961Mar 10, 1964 Method of repairing body tissue
US3364200 *May 19, 1965Jan 16, 1968Johnson & JohnsonOxidized cellulose product and method for preparing the same
US3580313 *Jan 7, 1969May 25, 1971Mcknight Charles ASurgical instrument
US3666750 *Dec 15, 1969May 30, 1972Johnson & JohnsonHemostatic material
US3744495 *Jul 19, 1971Jul 10, 1973Johnson MMethod of securing prolapsed vagina in cattle
US3823705 *Dec 26, 1972Jul 16, 1974Dow CorningBlood vessel bridging device
US4085756 *Sep 30, 1976Apr 25, 1978Kenneth WeaverMethod and apparatus for performing an electrosurgical procedure
US4193137 *May 6, 1977Mar 18, 1980Meadox Medicals, Inc.Warp-knitted double-velour prosthesis
US4400833 *Jun 10, 1981Aug 30, 1983Kurland Kenneth ZMeans and method of implanting bioprosthetics
US4452245 *Jun 23, 1982Jun 5, 1984Usher Francis CSurgical mesh and method
US4509516 *Feb 24, 1983Apr 9, 1985Stryker CorporationLigament tunneling instrument
US4520821 *Apr 30, 1982Jun 4, 1985The Regents Of The University Of CaliforniaGrowing of long-term biological tissue correction structures in vivo
US4633873 *Apr 26, 1984Jan 6, 1987American Cyanamid CompanySurgical repair mesh
US4652264 *Apr 25, 1985Mar 24, 1987American Cyanamid CompanyProsthetic tubular article
US4655221 *May 6, 1985Apr 7, 1987American Cyanamid CompanyMethod of using a surgical repair mesh
US4741330 *Apr 4, 1986May 3, 1988Hayhurst John OMethod and apparatus for anchoring and manipulating cartilage
US4838884 *Oct 17, 1986Jun 13, 1989American Cyanamid CompanyMethod of using a surgical repair mesh
US4850961 *Jul 30, 1987Jul 25, 1989Wanderer Alan AIndwelling placement device with guard
US4854316 *Oct 3, 1986Aug 8, 1989Davis Emsley AApparatus and method for repairing and preventing para-stomal hernias
US4857041 *May 7, 1987Aug 15, 1989National Research Development CorporationUrinary incontinence prostheses
US4905692 *Nov 5, 1987Mar 6, 1990K. T. Medical, Inc.Medical and orthopedic support fabric
US4911165 *Dec 12, 1988Mar 27, 1990Ethicon, Inc.Pliabilized polypropylene surgical filaments
US4938760 *Mar 29, 1989Jul 3, 1990American Medical Systems, Inc.Female suspension procedure
US4986831 *Apr 25, 1988Jan 22, 1991Angeion CorporationMedical implant
US4997434 *Feb 1, 1989Mar 5, 1991Seedhom Bahaa BProsthetic ligaments and instruments for use in the surgical replacement of ligaments
US5002551 *Aug 22, 1985Mar 26, 1991Johnson & Johnson Medical, Inc.Method and material for prevention of surgical adhesions
US5012822 *Sep 10, 1990May 7, 1991Schwarz Gerald RMethod for controlling urinary incontinence
US5013292 *Feb 24, 1989May 7, 1991R. Laborie Medical CorporationSurgical correction of female urinary stress incontinence and kit therefor
US5019032 *Apr 3, 1990May 28, 1991Robertson Jack RRefined suspension procedure with implement for treating female stress incontinence
US5026398 *Oct 9, 1990Jun 25, 1991The Minnesota Mining And Manufacturing CompanyAbrasion resistant prosthetic device
US5112344 *Oct 4, 1989May 12, 1992Petros Peter ESurgical instrument and method of utilization of such
US5122155 *Aug 19, 1991Jun 16, 1992Eberbach Mark AHernia repair apparatus and method of use
US5176692 *Dec 9, 1991Jan 5, 1993Wilk Peter JMethod and surgical instrument for repairing hernia
US5178630 *May 26, 1992Jan 12, 1993Meadox Medicals, Inc.Ravel-resistant, self-supporting woven graft
US5195542 *Apr 25, 1990Mar 23, 1993Dominique GaziellyReinforcement and supporting device for the rotator cuff of a shoulder joint of a person
US5289963 *Oct 18, 1991Mar 1, 1994United States Surgical CorporationApparatus and method for applying surgical staples to attach an object to body tissue
US5290217 *Oct 10, 1991Mar 1, 1994Earl K. SipesMethod and apparatus for hernia repair
US5292328 *Oct 18, 1991Mar 8, 1994United States Surgical CorporationPolypropylene multifilament warp knitted mesh and its use in surgery
US5304220 *May 3, 1993Apr 19, 1994Maginot Thomas JMethod and apparatus for implanting a graft prosthesis in the body of a patient
US5328077 *Nov 19, 1992Jul 12, 1994Lou Ek SengMethod and apparatus for treating female urinary incontinence
US5337736 *Sep 30, 1992Aug 16, 1994Reddy Pratap KMethod of using a laparoscopic retractor
US5381943 *Oct 9, 1992Jan 17, 1995Ethicon, Inc.Endoscopic surgical stapling instrument with pivotable and rotatable staple cartridge
US5382214 *Jun 9, 1993Jan 17, 1995Iwatani Sangyo Kabushiki KaishaMethod for fabricating a cardboard pallet and an apparatus for fabricating the same
US5383477 *Aug 4, 1993Jan 24, 1995Dematteis; Ralph A.Method and apparatus for laparoscopic repair of hernias
US5397332 *Sep 2, 1993Mar 14, 1995Ethicon, Inc.Surgical mesh applicator
US5425737 *Jul 9, 1993Jun 20, 1995American Cyanamid Co.Surgical purse string suturing instrument and method
US5425984 *Jun 9, 1993Jun 20, 1995United States Surgical CorporationBioabsorbable melt spun fiber based on glycolide-containing copolymer
US5437603 *Sep 14, 1993Aug 1, 1995C.R. Bard, Inc.Apparatus and method for implanting prostheses within periurethral tissues
US5441508 *Mar 22, 1993Aug 15, 1995Gazielly; DominiqueReinforcement and supporting device for the rotator cuff of a shoulder joint of a person
US5507796 *Apr 28, 1994Apr 16, 1996Hasson; Harrith M.Method of suspending a pelvic organ and instrument for performing the method
US5527341 *Aug 30, 1994Jun 18, 1996Synthes (U.S.A)Resorbable tendon and bone augmentation device
US5527342 *Dec 14, 1993Jun 18, 1996Pietrzak; William S.Method and apparatus for securing soft tissues, tendons and ligaments to bone
US5591163 *Jun 14, 1995Jan 7, 1997Incont, Inc.Apparatus and method for laparoscopic urethropexy
US5611515 *Apr 5, 1993Mar 18, 1997Boston Scientic CorporationBladder neck suspension procedure
US5620012 *May 16, 1994Apr 15, 1997Benderev; Theodore V.Method of percutaneously anchoring a suture to a bone
US5634931 *Sep 29, 1994Jun 3, 1997Surgical Sense, Inc.Hernia mesh patches and methods of their use
US5634944 *Feb 23, 1995Jun 3, 1997The Nemours FoundationBody membrane prosthesis
US5639274 *Jun 2, 1995Jun 17, 1997Fischell; Robert E.Integrated catheter system for balloon angioplasty and stent delivery
US5641502 *Jun 7, 1995Jun 24, 1997United States Surgical CorporationBiodegradable moldable surgical material
US5641566 *Dec 6, 1995Jun 24, 1997W. L. Gore & Associates, Inc.High strength porous PTFE sheet material
US5643288 *Jun 14, 1995Jul 1, 1997Incont, Inc.Apparatus and method for laparoscopic urethropexy
US5643596 *Jun 7, 1995Jul 1, 1997Clarion Pharmaceuticals, Inc.Hemostatic patch
US5645849 *Jun 7, 1995Jul 8, 1997Clarion Pharmaceuticals, Inc.Hemostatic patch
US5645915 *Mar 29, 1996Jul 8, 1997W. L. Gore & Associates, Inc.High strength porous PTFE sheet material
US5707647 *Nov 14, 1996Jan 13, 1998Atrix Laboratories, Inc.Adjunctive polymer system for use with medical device
US5733337 *Apr 7, 1995Mar 31, 1998Organogenesis, Inc.Tissue repair fabric
US5741323 *Jun 7, 1995Apr 21, 1998Focal, Inc.Polymeric article for intraluminal photothermoforming
US5749884 *Nov 23, 1994May 12, 1998Boston Scientific Technology, Inc.Bone anchor implantation device and method
US5766221 *Feb 9, 1995Jun 16, 1998Boston Scientific Technology, Inc.Bone anchor implantation device
US5769864 *Nov 22, 1996Jun 23, 1998Surgical Sense, Inc.Hernia mesh patch
US5899909 *Feb 25, 1997May 4, 1999Medscand Medical AbSurgical instrument for treating female urinary incontinence
US5904692 *Apr 14, 1997May 18, 1999Mitek Surgical Products, Inc.Needle assembly and method for passing suture
US5922026 *May 1, 1997Jul 13, 1999Origin Medsystems, Inc.Surgical method and prosthetic strip therefor
US6039686 *Jul 8, 1998Mar 21, 2000Kovac; S. RobertSystem and a method for the long term cure of recurrent urinary female incontinence
US6040583 *May 22, 1998Mar 21, 2000Nec CorporationElectron beam exposure method using a moving stage
US6042534 *Feb 13, 1998Mar 28, 2000Scimed Life Systems, Inc.Stabilization sling for use in minimally invasive pelvic surgery
US6042536 *Aug 13, 1998Mar 28, 2000Contimed, Inc.Bladder sling
US6050937 *Sep 21, 1998Apr 18, 2000Benderev; Theodore V.Surgical tension/pressure monitor
US6053935 *Nov 8, 1996Apr 25, 2000Boston Scientific CorporationTransvaginal anchor implantation device
US6059801 *Mar 24, 1998May 9, 2000Samimi; DariusBladder saver retropubic ligature carrier device
US6068591 *Feb 17, 1998May 30, 2000Bruckner; Norman I.Pubo-urethral support harness apparatus for percutaneous treatment of female stress urinary incontinence
US6090116 *Oct 3, 1997Jul 18, 2000D'aversa; Margaret M.Knitted surgical mesh
US6200330 *Nov 23, 1998Mar 13, 2001Theodore V. BenderevSystems for securing sutures, grafts and soft tissue to bone and periosteum
US6221005 *Sep 7, 1999Apr 24, 2001Norman I. BrucknerPubo-urethral support harness apparatus for percutaneous treatment of female stress urinary incontinence with urethal hypemobility
US6264676 *Jan 26, 1999Jul 24, 2001Scimed Life Systems, Inc.Protective sheath for transvaginal anchor implantation devices
US6406423 *Jan 21, 2000Jun 18, 2002Sofradim ProductionMethod for surgical treatment of urinary incontinence and device for carrying out said method
US6423080 *Feb 13, 1998Jul 23, 2002Scimed Life Systems, Inc.Percutaneous and hiatal devices and methods for use in minimally invasive pelvic surgery
US6530943 *Nov 20, 2000Mar 11, 2003Ethicon, GmbhSurgical needle for implanting a tape
US6685629 *May 22, 2002Feb 3, 2004Sofradim ProductionSuburethral support assembly in treatment of female urinary stress incontinence
US6689047 *Nov 14, 2001Feb 10, 2004Scimed Life Systems, Inc.Treating urinary incontinence
US6752814 *Nov 12, 2001Jun 22, 2004Scimed Life Systems, Inc.Devices for minimally invasive pelvic surgery
US6872227 *Dec 11, 2000Mar 29, 2005Ethicon GmbhStrip-like implant
US6916225 *Dec 19, 2000Jul 12, 2005Nikon CorporationMonitor, method of monitoring, polishing device, and method of manufacturing semiconductor wafer
US7014607 *Nov 26, 2003Mar 21, 2006Boston Scientific Scimed, Inc.Treating urinary incontinence
US20020055748 *Nov 12, 2001May 9, 2002Gellman Barry N.Devices for minimally invasive pelvic surgery
US20020072694 *Aug 24, 2001Jun 13, 2002Snitkin Eva S.Coated sling material
US20030009181 *Mar 7, 2002Jan 9, 2003Gellman Barry N.System for implanting an implant and method thereof
US20030045774 *Oct 25, 2002Mar 6, 2003Staskin David R.Sling delivery system and method of use
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US8123671Aug 3, 2006Feb 28, 2012C.R. Bard, Inc.Pelvic implant systems and methods
US8480559Sep 12, 2007Jul 9, 2013C. R. Bard, Inc.Urethral support system
US8574149Jun 15, 2012Nov 5, 2013C. R. Bard, Inc.Adjustable tissue support member
US8845512Jan 6, 2012Sep 30, 2014C. R. Bard, Inc.Sling anchor system
US20040260113 *Aug 30, 2002Dec 23, 2004Wilfried BueschkenMixture of alicyclic polycarboxylic esters with high cis content
US20110015473 *Jan 20, 2011Teslux Holdings S.A.Vaginal operation method for the treatment of urinary incontinence in women
Classifications
U.S. Classification600/39
International ClassificationA61F5/00, A61F2/00, A61B17/00, A61B17/06, A61B17/04
Cooperative ClassificationA61F2/0036, Y10S128/25, A61B2017/00805, A61F2/0045, A61B17/0401, A61B2017/06052, A61F2/0063
European ClassificationA61B17/04A, A61F2/00B6B, A61F2/00B6B4
Legal Events
DateCodeEventDescription
May 22, 2008ASAssignment
Owner name: SCIMED LIFE SYSTEMS, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:GELLMAN, BARRY N.;REEL/FRAME:020999/0639
Effective date: 20011114
Owner name: BOSTON SCIENTIFIC SCIMED, INC., MINNESOTA
Free format text: CHANGE OF NAME;ASSIGNOR:SCIMED LIFE SYSTEMS, INC.;REEL/FRAME:020998/0963
Effective date: 20041222