# Patent

## Title
Transobturator surgical articles and methods

## Abstract

Described is a surgical instrument and method for treating female urinary stress incontinence. The instrument includes a first curved needle-like element defining in part a curved shaft having a distal end and a proximal, a mesh for implanting into the lower abdomen of a female to provide support to the urethra; a second curved needle element having a proximal end and a distal end, and a coupler for simultaneous attachment to the distal end of the first needle and the distal end of the second needle.

## Background
CROSS REFERENCE TO RELATED APPLICATION
The present invention is a continuation-in-part of co-pending U.S. patent application, Ser. No. 09/521,801, filed on Mar. 9, 2000, which claims the benefit of earlier-filed U.S. provisional patent application, Ser. No. 60/138,231, filed on Jun. 9, 1999, which are both incorporated by reference in their entirety herein.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a surgical instrument and a method for treating female urinary incontinence and in particular to a needle and mesh configuration for creating a sling beneath the urethra.
2. Background Discussion
Women account for more than 11 million of incontinence cases. Moreover, a majority of women with incontinence suffer from stress urinary incontinence (SUI). Women with SUI involuntarily lose urine during normal daily activities and movements, such as laughing, coughing, sneezing and regular exercise. SUI may be caused by a functional defect of the tissue or ligaments connecting the vaginal wall with the pelvic muscles and pubic bone. Common causes include repetitive straining of the pelvic muscles, childbirth, loss of pelvic muscle tone, and estrogen loss. Such a defect results in an improperly functioning urethra. Unlike other types of incontinence, SUI is not a problem of the bladder.
Normally, the urethra, when properly supported by strong pelvic floor muscles and healthy connective tissue, maintains a tight seal to prevent involuntary loss of urine. When a woman suffers from the most common form of SUI, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its correct position. As a result, during normal movements when pressure is exerted on the bladder from the diaphragm, the urethra cannot retain its seal, permitting urine to escape. Because SUI is both embarassing and unpredictable, many women with SUI avoid an active lifestyle, shying away from social situations.

    
    
        U.S. Pat. No. 5,112,344 describes a method and apparatus for treating female incontinence. The surgical instrument for the application of a filamentary element into the body comprises a tubular shaft having a handle at one end and a flexible needle slidably receivable in the shaft and adapted at one end to receive filamentary element. The method of treating female incontinence comprises looping a filamentary element between the wall of the vagina and the rectus abdomens sheath in the anterior wall of the abdomen whereby it passes to each side of the urethra, tightening the loop to bring the vaginal wall and the urethra into the correct spatial relationship to the pubis allowing the development of scar tissue between the vaginal wall and the anterior wall of the abdomen pubic symphysis and removing the filamentary element.
    
    


U.S. Pat. No. 5,899,909 discloses a surgical instrument comprising a shank having a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements which are connected at one end to one of a mesh intended to be implanted into the body. In practice, the mesh is passed into the body via the vagina first at one end and then at the other end at one side and the other, respectively, of the urethra to foam a loop around the end at one side and the other, respectively, of the urethra to form a loop around the urethra, located between the urethra and vaginal wall. The mesh is extended over the pubis and through the abdominal wall and is tightened. The mesh ends are cut at the abdominal wall, and the mesh is left implanted in the body. The trans-vaginal procedure is exemplified by the TVT product sold by the Gynecare franchise of Ethicon Inc., a Johnson & Johnson Company, of Somerville, NJ, USA. In this procedure two 5 mm needles pass a PROLENE mesh trans-vaginally and through the abdomen to create a tension-free support around the mid urethra. U.S. Pat. No. 5,899,909 is incorporated herein by reference in its entirety.
An alternate method to treat SUI is the sling procedure. In this procedure a needle or other suture-retrieving device is first inserted through the abdomen, above the pubic bone. The needle is guided behind the pubic bone, through the subrapubic fascia around the urethra, and out of the body through an incision in the anterior vaginal wall. At this point sutures are attached to the needle(s) and pulled up back through the abdominal cavity, where the sutures are fastened to the rectus muscle.
Techniques for protecting against the puncture of the internal structures during this type of procedure have included laparoscopic procedures. This involves making an incision in the abdomen and inserting a video scope to watch the progress of the needles as they pass through the abdominal cavity. These additional incisions are not optimal for the patient. Also, the needles which pass through the abdomen are not designed to capture a mesh but rather a suture which has been previously attached to the mesh or harvested fascia. These needles are generally in the diameter range of about 0.090 ins. to about 0.120 inches. Therefore, the needles do not create a large channel through the fascia. The channel is only wide enough to pass the suture. Accordingly, the sutures do not possess the elongation properties of the PROLENE mesh and therefore can not provide the tension-free support of the TVT. Also attaching a mesh directly to these needles is not optimal because it is very difficult, if at all possible, to pull the mesh through the narrow channel created by the needle.
It would be beneficial to provide a surgical system for use in implanting a mesh within a female body to prevent incontinence that can be implanted either through a trans-vaginal approach of a trans-abdominal approach.
This invention addresses that need and overcomes the deficiencies of the prior art.
SUMMARY OF THE INVENTION
The invention overcomes the deficiencies of the prior art and provides for a surgical apparatus and a method for the treatment of female stress urinary incontinence. The invention provides a surgical instrument comprising a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements, each of which have a blunt tip and a constant or varying diameter. The distal end of the needle comprises an interlocking coupling means for accepting a guide needle or, alternatively, a mesh.
In one embodiment each curved needle connects at its proximal end to separate ends of a mesh to be implanted within the body. A guide needle, similar in structure to a Stamey needle, is passed through the abdomen and behind the pubic bone, passes along one side of the urethra and to an incision site at the anterior vaginal wall. After the guide needle exits the body through the vagina, the guide needle couples to the distal end of the curved needle. The curved needle is then pushed back through the vagina and through the fascia, following the path of the guide needle. The curved needle and first end of the mesh pass over the pubis and through the abdominal wall. The guide needle is again passed behind the pubic bone from the abdomen, passes along the other side of the urethra to the incision site in the vaginal wall. The guide needle again couples to the distal end of the second curved needle, which then passes through the vagina and fascia, following the second path created by the guide needle. The second end of the mesh is extended over the pubis and through the abdominal wall. The mesh ends are cut at the abdominal wall, and the mesh is left in the body, creating a tension- free support between the vaginal wall and the mid urethra.
In an alternate embodiment a curved needle is passed through the abdomen and behind the pubic bone, passes along one side of the urethra and to an incision site in the anterior vaginal wall. After the curved needle exits the body through the vagina, the distal end of the curved needle couples to one end of the mesh to be implanted within the body. The curved needle is then pulled back through the vagina and through the fascia, following the path it originally created. The curved needle and first end of the mesh pass over the pubis and out through the abdominal wall. The first end of the mesh de-couples from the curved needle and the needle is again passed behind the pubic bone from the abdomen, passes along the other side of the urethra to the incision site in the vaginal wall. The needle couples to second end of the mesh and is then pulled back through the vagina and fascia, following the second path created by the needle. The second end of the mesh is extended over the pubis and through the abdominal wall. The mesh ends are cut at the abdominal wall, and the mesh is left in the body, creating a tension-free support between the vaginal wall and the mid urethra.
The invention is also compatible for use in a trans-vaginal approach as described in U.S. Pat. No. 5,899,909.
The object of the invention is to provide a surgical instrument that implants a mesh for treatment of SUI and is capable for using in a trans-vaginal or a trans-abdominal procedure.
An advantage of the invention is that it is useful across different medical specialties depending on preferred surgical approaches.
These and other features and advantages of the present invention will become apparent from the following more detailed description, when taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side view of the needle in one embodiment thereof;
FIG. 2a is a side view of two needles and a mesh interconnecting the needles;
FIGS. 2b-d are alternate embodiments of the mesh and connecting means between the mesh and needle;
FIG. 3a is an assembly diagram for two needles and a connector;
FIGS. 3b-d are alternate embodiments of a connector for use in FIG. 3a;
FIGS. 4a-j diagrammatically illustrate several surgical steps of a trans-abdominal method utilizing two needles and guide needle according to the invention to treat SUI;
FIGS. 5a-d illustrate alternate embodiments of coupling the guide needle to the needle;
FIGS. 6a-h diagrammatically illustrate several surgical steps of a trans- abdominal method utilizing a single needle according to an alternate embodiment of the invention to treat SUI;
FIGS. 7a-g illustrate alternate embodiments of coupling the needle to the mesh; and
FIGS. 8a-i diagrammatically illustrate several surgical steps of a trans. abdominal method utilizing two needles and two guide needles according to the invention to treat SUI.



DETAILED DESCRIPTION OF THE INVENTION
Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description, because the illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways.
The invention discloses an apparatus and method for treating SUI. A mesh or tape is passed through pelvic tissue and positioned between the urethra and vaginal wall, creating a supportive sling. The mesh provides a structure means for tissue ingrowth and thereby provides a newly created body tissue supporting means for the urethra. When pressure is exerted upon the lower abdomen, such as during a cough or sneeze, the mesh provides support to the urethra, allowing it to keep its seal and prevent the unwanted discharge of urine.
Referring to FIGS. 1 and 2a, in one embodiment the surgical instrument comprises a needle-like element 10 that attaches to a mesh 12. Needle element 10 defines a certain radius R to perform the surgical procedure discussed herein. The distal end of needle element 10 terminates at a conical section 14 having a tip 16. Alternate configurations, such as a blade-like, arrow or burr tips are also possible. Preferably, tip 16 is blunt, wherein the tip 16 has a radius of about 0.6 millimeters. A blunt tip is preferred since it is less likely to stick in bone or penetrate bladder wall tissue or blood vessel wall tissue as will be appreciated from the method of implanting the mesh as described below.
The proximal end of needle 10 terminates in an attachment segment 20 that is adapted to mate and lock into a handle 21 as disclosed in U.S. Pat. No. 5,899,909.
Disposed between tip 14 and segment 20 is a curved shaft segment 18 having a distal end 17 and a proximal end 19. The shape of shaft 18 extends substantially a quarter of a circle in order to follow substantially the profile of the pubis between the vagina and the abdominal wall. For the purposes of the method as will be discussed in more detail below, shaft 18 has a preferred radius R of about 106 millimeters. The diameter of shaft 18 may be constant, for example, about 5 mm. Alternatively, the diameter of segment 18 may transition from a smaller diameter at distal end 17 to a larger diameter at proximal end 19. The minimum diameter of distal end 17 may be as small as 0.5 mm due to the minimal stresses at this point. The minimal diameter of proximal end 19 is about 4 mm.
Needle 10 is preferably tubular with a circular cross section and is made from a material that is compatible with the human body. Preferably, needle 10 is made from AISI 303 stainless steel. The surface of shaft 18 may be smooth, preferably polished, to facilitate penetration of the soft tissue. Alternatively, the surface of needle 10 may have a somewhat rougher surface. A rougher surface would result in slightly additional tissue trauma, which in turn stimulates fibroblast activity around the mesh 12. The surface of needle 10 may also be darkened in shade or color to provide higher visibility while in place in the body during a cystoscopy.
Needle 10 may be manufactured as a single, continuous unit, or alternatively, curved portion 18 may be manufactured separately from linear portion 20. In this manner the two pieces would attach using any conventional attaching means, such as, screwing, or other conventional means as is known to those skilled in the art.
Referring to FIGS. 2a-d, mesh 12 comprises any tissue-compatible synthetic material, or any natural material, including, but not limited to, autologous, allograft, xenograft, a tissue engineered matrix, or a combination thereof. An exemplary synthetic material is PROLENE®polypropylene mesh, a mesh having a thickness of 0.7 mm and openings of about 1 mm manufactured by Ethicon, Inc., Somerville, New Jersey, U.S.A. This material is approved by the U.S. Food and Drug Administration for implantation into the human body. A still further embodiment of the mesh 12 is a combination of a synthetic material 11 and a natural material 13 centered between the synthetic material 11 as shown in FIGS. 2b-c. A still further embodiment of the mesh 12 includes a combination of synthetic material 11 and natural material 13, whereby the natural material is placed over or incorporated within a generally central portion of the synthetic material 11. One advantage of the mesh configurations is that natural material 13 is along the center region of mesh 12 so that after installation of mesh 12, natural material 13 is positioned below the urethra and eliminates possible erosion issues at the interface of the urethra and mesh. Natural material 13 may be connected to the synthetic material 11 by means of sewing, a bio-compatible glue, cell culturing techniques or other known means.
Mesh 12 may be of any convenient shape that suits the intended purpose of the invention. An exemplary width is about 1 cm and the length would be dependent upon the size of the female undergoing the procedure. Mesh 12 may be single or double ply, generally planar in structure, or tubular (FIG. 2d) to provide additional supporting strength and more surface area on which tissue fibers may attach. Moreover, mesh 12 may consist of different types of material, such as a bloabsorbable and non-bioabsorbable material. Mesh 12 may also be coated with an antimicrobial additive to prevent or minimize infection and a lubricous coating, for example, a bioabsorbable hydrogel, to facilitate the mesh passing through the tissue as discussed below. Preferably, mesh 12 is covered by a removal plastic sheath as disclosed in U.S. Pat. No. 5,899,909. The mesh may also be made radio-opaque and/or of a contrasting color to the body tissue to allow for future diagnostic visualization. In one embodiment mesh 12 may be attached to needle segment 20 by means of tying, gluing or other suitable attaching means. Preferably, a bio- compatible heat shrink tube fixes mesh 12 onto needle portion 20, FIG. 2a.
FIG. 3a illustrates a needle 10 for use in conjunction with a guide needle 110 and coupler 112. Guide needle 110 may be configured to have a similar radius R as needle 10. Preferably, guide needle 110 has a smaller diameter, about 2 mm. It is possible, however, for guide needle 110 to have the same diameter as needle 10. A coupler 112 acts as an interfacing element useful to couple guide needle 110 to needle 10. Coupler 112 is substantially elliptical-shaped having a first bore opening 114 for accepting distal end 17 and a second bore opening 116 for accepting the distal end of guide needle 110. Preferably, openings 116 and 114 are configured to allow for a press fit connection with needles 110 and 10, respectively. Alternatively, openings 114 and 116 may comprise a bio-compatible glue or high-friction material to facilitate a strong connection between the needles 10/110 and coupler 112. Coupler 10 may be made from any bio-compatible metal, such as stainless steel or polyurethane, silicone, rubber or other similar compound.
FIGS. 3b-d illustrate alternate connector means utilizing a high friction tube 170, such as Tygon. FIG. 3b discloses a tube having a constant O.D., but a varying l.D. The larger l.D. would accept needle 10 and the smaller l.D. accepts the guide needle 110. FIG. 3c illustrates a tube 172 having both a varying O.D. and l.D. As the needles are placed within the tube the decreasing I.D. compresses around the distal ends of the respective needles and the high coefficient of friction securely anchors the needles. FIG. 3d illustrates the needles within the tube 172. Preferably, the ends of tube 170 and 172 are tapered to eliminate any abrupt surface that adds additional drag to the needles as they are pulled through the abdominal cavity.
The surgical procedure for trans-abdominally implanting mesh 12 using two needles is shown in FIGS. 4a-j. In the figures the relevant parts of the female lower abdomen are disclosed, the vagina being 50, the uterus 52, the urethra 54, the pubic bone 56, the urinary bladder 58 and the abdominal wall 60, A guide needle 110 penetrates the abdominal wall 60, anterior to the pubic bone 56, FIG. 4a and follows the contour of the pubic bone 56 to one side of the urethra 54 and exits the body through an incision having been made in the anterior wall of the vagina 50. Coupler 112 attaches to the distal end of guide needle 110, extending out from the body, and needle 10a, FIG. 4b. One end of mesh 12 is attached to the proximal end of needle 10a. The surgeon then retracts guide needle 110 back through the abdomen and advances needle 10a through the vaginal incision following the same path guide needle 110 created, FIG. 4c. The needles pass through the vaginal wall and through the soft tissue on one side of the urethra 54, the needles then according to FIG. 4d being passed close to the back of the pubic bone 56, through additional layers of fat, muscle and fascia, and then out the abdominal wall 60 above the pubic bone 56. The surgeon uncouples handle 21 from the needle 10a and pulls needle 10a out of the body through the abdominal wall 60, FIG. 4e. Guide needle 110 is disconnected from needle 10a, and the surgeon repeats the same procedure, but passing the guide needle 110 on the opposite side of the urethra 54, FIGS. 4f-j, to complete the implantation of the mesh between the mid- urethra and vaginal wall using needle 10b.
FIGS. 8a-i illustrate an alternate preferred embodiment. A first guide needle 110a penetrates the abdominal wall 60, anterior to the pubic bone 56 and follows the contour of the pubic bone 56 to one side of the urethra 54 and exits the body through an incision having been made in the anterior wall of the vagina 50. A second guide needle 110b penetrates the abdominal wall 60, anterior to the pubic bone 56 and follows the contour of the pubic bone 56 to the opposite side of the urethra 54 as guide needle 110a and exits the body through an incision having been made in the anterior wall of the vagina 50, FIG. 8a. At this point, the surgeon may perform a single cystoscopy to confirm the integrity of the bladder 58. Couplers 112a,b attach to the distal ends of needles 10a,b. Needle 10a, having one end of mesh 12 attached to the proximal end of needle 10a attaches to guide needle 110a via coupler 112a, FIG. 8b. The surgeon then retracts guide needle 110a back through the abdomen and advances needle 10a through the vaginal incision following the same path guide needle 110a created. The needles pass through the vaginal wall and through the soft tissue on one side of the urethra 54, the needles being passed close to the back of the pubic bone 56, through additional layers of fat, muscle and fascia, and then out the abdominal wall 60 above the pubic bone 56, FIGS. 8c-d. The surgeon uncouples handle 21 from the needle 10a and pulls needle 10a out of the body through the abdominal wall 60, FIG. 8e.
The surgeon repeats the same procedure, but removing guide needle 110b and advancing needle 10b on the opposite side of the urethra 54, to complete the implantation of the mesh between the mid-urethra and vaginal wall using needle 10b, FIGS. 8f-i. 
FIGS. 5a-d illustrate alternate embodiments for coupling needle 10 to guide needle 110 to implant a mesh 12 trans-abdominally as indicated above. In FIGS. 5a-b, the distal end of needle 10 is modified to include a bore opening 118 to allow for a press fit connection with the distal end of guide needle 110. Alternatively, bore-opening 118 may comprise other connection means, such as glue or a high-friction material.
In FIG. 5c, the distal end of needle 10 is modified to include a bore opening 120 and a locking pin 122. Guide needle 110 is modified to include an L-shaped groove 124. The distal end of guide needle 110 inserts into opening 120 and groove 124 engages locking pin 122 and locks thereto with a quarter-turn twist.
FIG. 5d illustrates a bore opening 126 in guide needle 110 to accept a protruding element 128 at the distal end needle 10. Protruding element 128 press fits into bore opening 126.
One advantage of the embodiment shown in FIG. 3 is that the needle 10 can be used for either a trans-abdominal approach or a trans-vaginal approach. In this approach, a kit comprising two needles 10, attached to a mesh 12, at least one coupler and at least one guide needle may be distributed for use by multiple surgeon specialists. For example, a gynecologist may prefer the trans-vaginal approach and will simply discard the connector and guide needle from the kit. On the other hand, a urologist may prefer the trans-abdominal approach and utilize the connector(s) and guide needle(s).
Referring now to FIGS. 6a-h, an alternate embodiment of the invention utilizes the needle 10 to penetrate the abdominal wall 60 and couple to the mesh 12. In this embodiment, the mesh 12 is modified to create a connection means for connecting to the distal end of the needle 10. The connection means is preferably detachable so that when the mesh is pulled out of the abdominal wall, the mesh may be detached from the needle and the needle reused to retrieve the other end of the mesh. This embodiment allows for the use of a single needle for the procedure. This embodiment also allows for the use of a mesh constructed, at least in part, of natural materials, which are otherwise not suitable in the pre-affixed embodiment due to the inability of the natural material to survive extended periods in inventory.
A needle 10 with coupling means at the distal end penetrates the abdominal wall 60, anterior to the pubic bone 56, FIG. 6a and follows the contour of the pubic bone 56 to one side of the urethra 54 and exits the body through an incision having been made in the anterior wall of the vagina 50, FIG. 6b. A first end of mesh 12 attaches to the distal end of needle 10 via coupling means. The surgeon then retracts needle 10 back through the pelvic cavity, following the same path created by needle 10, while at the same time causing mesh 12 to follow the needle, FIG. 4c, The needle 10 and mesh 12 pass through the vaginal wall and through the soft tissue on one side of the urethra 54. The needle and mesh then according to FIG. 4f being passed close to the back of the pubic bone 56, through additional layers of fat, muscle and fascia, and then out the abdominal wall 60 above the pubic bone 56.
Needle 10 disconnects from the first mesh end, and the surgeon repeats the same procedure, but this time passes the needle 10 on the opposite side of the urethra 54, FIGS. 6d-h, to complete the implantation of the mesh 12 between the mid urethra and vaginal wall.
Referring to FIGS. 7a-g, alternate embodiments for connecting the needle 10 to the mesh 12 are disclosed. FIGS. 7a-b disclose a coupler 130 having a proximal end 132 configured to accept the mesh 12 and a distal end 134 for accepting the distal end 17 of needle 10. Distal end 17 comprises a contiguous groove 120 for detachably coupling with coupler 130. Coupler 130 further comprises two spring tabs 136 and 138, each with fingers 140 and 142 for engaging groove 120. Mesh 12 is preferably attached to the distal end 132 using a biocompatible glue or other appropriate mechanical fastening means. The surgeon may simply attach or detach needle 10 from coupler 130 by depressing spring tabs 136 and 138 forcing fingers 140 and 142 upward to allow distal end 17 to slide in or out of coupler 130. Fingers 140 and 142 engage groove 120 to hold needle 10 firmly in place within coupler 130.
FIGS. 7c-e illustrate a coupling mechanism 150 similar in function to a safety pin. Spring arm 152 engages with a bore 154 at the distal end 17 of needle 10.
FIGS. 7f-g illustrate a loop coupling mechanism 160 attached to mesh 12 for engaging groove 120.
As would be appreciated by one skilled in the art, there exist multiple means for detachably connecting the mesh to the needle.
Since all procedures may be performed using a local anesthesia, the patient is able to provide feedback to the surgeon after mesh 12 is in place. Typically, the urinary bladder 58 is filled with a fluid, such as water, using a catheter and the patient is requested to cough. The surgeon is able to determine the operation of the urethra and may adjust the placement of the mesh 12, as necessary, by adjusting the ends of mesh 12 located at the outside of the abdomen 60, FIGS. 4h and 5h. After adjustments, the surplus mesh at the abdomen is cut off, and the ends of the mesh are secured within the abdomen and the abdomen is closed. Likewise, the incision at the vaginal wall is dosed whereby the tissue flap seals the mesh between the urethra 54 and the wall of vagina 50.
Mesh 12 is left in the body and forms an artificial ligament attached to the abdominal wall that provides the support for the urethra as required in order to restore urinary continence to the patient.
It will be apparent from the foregoing that, while particular forms of the invention have been illustrated and described, various modifications can be made without departing from the spirit and scope of the Invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.
A modification to the idea of using guides to assist in placing the mesh within the abdominal cavity to repair stress urinary incontinence is to complete the repair of pelvic floor defects. A mesh is placed within the pelvic floor to correct a cystocele or enterocele or rectocele or other prolapse. This concept discloses the method and instrumentation to place the mesh using, either a laparoscopic technique or blind approach with the guides to affix the mesh.
Prolapse is a condition in which organs, namely the bladder, bowel and uterus, which are normally supported by the pelvic floor, herniate or protrude into the vagina. This occurs as a result of damage to the muscles and ligaments making up the pelvic floor support. Childbirth is the most common cause of damage to the pelvic floor, particularly where prolonged labor, large babies and instrumental deliveries were involved. Other factors include past surgery such as hysterectomy, lack of estrogen due to the menopause, and conditions causing chronically raised intra abdominal pressure such as chronic constipation, coughing, and heavy lifting.
Vaginal surgery is the usual method of repair. Abdominal surgery, on the other hand, Is usually performed when there is urinary stress incontinence or when vaginal surgery has failed. The choice of technique will generally depend upon the type, the severity of the prolapse and the surgeon's experience. Recent advances in laparoscopic surgery have helped surgeons repair many pelvic floor defects, which are often difficult to reach by the vaginal method. Examples include prolapse of the vaginal vault, enterocele and paravaginal cystocele.
In the laparoscopic procedure, the surgeons insert a tiny telescope (laparoscope) through a small incision at the umbilicus. This is attached to a camera-television setup, giving the surgeons a magnified view of the pelvic floor. Via three keyhole incisions in the abdomen, the surgeons use specially designed instruments to lift and attach the prolapsed organs back to the ligament and muscle support with many non-absorbable sutures. The sutures act as a bridge allowing scar tissue to form the long-term support.
Surgeons can also make this repair by inserting a layer of mesh through the anterior vaginal wall. The corners of the mesh are attached with sutures to the ligaments and muscles on the sidewalls of the pelvis. The suturing can be done via access through the abdomen as above or by access through the vaginal incision.
Instead of suturing the sheet of mesh to the ligaments, the mesh is suspended from one or more strips of mesh attached at the edges of the main portion of the sheet. The suspension is completed to the abdominal rectus muscle or to the pelvic bone or other ligaments or muscles within the pelvis such as Cooper's ligament or the obturator muscle. Repair of a prolapse can also include passage of the guides and mesh through the obturator fossa or any other fossa in the pelvic bone. Alternately it can be attached along the levator ani muscle at the level of the arcus tendoneius. Portions of the mesh strips are pulled up through the abdominal rectus muscle or other muscle or are attached to the pelvic bone and held in place there by the friction between the mesh and muscle, similar to the TVT attachment.
To accomplish this, a long blunt needle or shaft is passed, under laparoscopic view or blindly with palpation, from the abdomen through the rectus muscle and out the vaginal incision. The mesh is attached to the tip of the needle similar to the attachment of the TVT AA device. The needle is pulled back out of the vagina and abdomen. This is repeated on all corners of the mesh suspending it under the bladder or other organ to hold it in place.
The mesh can be shaped into configurations, which would provide areas of support. Based on the requirements of the repair these configurations can consist of straight strips, crossed strips, a broad or elongated sheet with strips attached to the edges, or diagonal connections.
FIG. #9 shows the configuration of a sheet of mesh with strips extending from two edges. The strips would be pulled through the muscle or ligaments to hold the sheet in place under the organ to be supported. The strips would be inserted through the tissue by attaching them to a needle or shaft. The needle could then be attached to a guide which has been passed through the tissue from the opposite direction, and which has created a path for the needle and strip to egress.
Alternately, the needles could be passed through the tissue pulling the mesh strip behind without the aid of the guide.
FIG. #10 shows a side view of the mesh placed in a front to back position in the body.
FIG. #11 shows a frontal view of the strips, which are placed front to back.
FIG. #12 shows a side view of the front to back placement with the front end of the strip attached to the pubic bone or pubic symphysis.
FIG. #13 shows the strips with crossing bands connecting them under the area, which is to be supported. This band could also be a solid sheet between the two strips.
FIG. #14 is a frontal view of the mesh as it is suspended from two strips with a central connecting section.
FIG. #15 shows the strips in a side view, placed front to back and crossing each other under the organs to be supported.
Positioning of the tape under the organs to be supported is also disclosed here. FIG. #16 shows a side view of the female urogenital organs with an incision made In the mid vagina on the anterior wall. This incision would be approximately 1.5 cm and cut with a scalpel. Blunt dissection would be performed to separate the layers of the vagina. The guide is inserted into a puncture incision along the rim of the pubic bone about 2 cm from mid line. The guide is advanced to the inferior rim of the pubic bone. A finger is inserted into the vaginal incision and is advance toward the pubic symphysis. The tip of the guide is rotated or angled to the posterior section of the vagina and the finger palpates the guide tip. Once the finger and tip are in contact the guide is advanced through the thin layer of tissue on the top of the vagina. The guide is then push out of the vagina where the needle is connected to it via a coupling device. The guide is extracted from the vagina and abdomen pulling the mesh strip and needle with it. FIG. #17 shows the placement of the mesh strip under the bladder.
Additional incisions can be made on each side of the abdomen further along the lateral rim of the pelvic bone. The guide is inserted through these incisions, one at a time. and into the vagina by means of the finger guiding it. Additional strips of the mesh are attached to the guides via the needle and extracted out of the vagina and abdomen. FIG. #18 shows positions of the incisions. FIG. #19 shows a side view with two strips of mesh in place to provide a wider support area. FIG. #20 shows a frontal view of the procedure with a sheet of mesh inserted in the anterior vaginal wall, and strips of mesh extending from its edges and exiting either out of the abdomen, or being secured onto the soft tissue of the pelvic bone, i.e. the tendonous arch or white line.
The position of the mesh is not restricted to the anterior wall of the vagina. It may be placed under the vagina, under the bladder, under the rectum and along the levator ani muscle. When the organs are supported by strips alone the strips can be placed alongside or on top of or underneath the ligaments which are attached to these organs or which are supporting the organs either directly of indirectly. Examples of these type tissues are external anal sphincter, ischio- caverous muscle, central tendon of the perineum, endopelvic fascia such as; urethrovesical, vagino-uterine and rectal. Some examples of ligamentous tissue which can be supported as well are sacrotuberous ligament, sacrospinous ligament, broad ligament and cardinal ligaments.
Passage of the guides and mesh are not limited to, through the vagina. The guides can also be inserted through the anus and penetrate the rectum to exit the ischial fossa or obturator fossa to suspend mesh through those portals. Additional combinations of passage routes include; from the iliac crest to the pubis; from the Ischial spine to the pubis; from right Ischial spine to left Ischial spine and others.
Additional configurations of the mesh include:
FIG. #21 a ladder shape with multiple strands connecting the strips.
FIG. #22 an “X” connecting the strips.
FIG. #23 perpendicular and diagonal strands connecting the strips.
FIG. #25 diagonal strands connecting the strips In order to enhance the passage of the guide through the abdominal cavity it will be necessary for some procedures to have guides, which have different shapes and lengths. The basic guide has a single curve in the shaft, FIG. #26. Other configurations can have “S” curves, FIG.#27. Further shapes can be curves in multiple planes. The shaft can also contain a hinged section which is rotateable and lockable The direction of the guide can be accomplished with a simple hinge or complex hinges along the shaft. Additional designs can include flexible shafts, directable shafts, and stearable shafts. Other designs can incorporate sections, which are rigid and sections, which are flexible or stearable. The use of certain materials can also enhance the passage of the guides through the body. Materials, which can be used, are shape memory alloys and plastics, which deploy to specific shapes under changes in temperature. These materials can also include a super elastic property, which allows significant bending with low force applied and without permanent deformation. The superelastic material can be combined with a cannula so that the cannula makes the initial passage and the memory material is extended beyond the cannula to finish the curved track. Additionally, the superelastic material can be passed through a curved cannula and as it exits continues on a straight path. In this instance the shaft can be constructed from a single or double central core wire which is wrapped with a tight coil of wire producing a configuration which has the flexibility of a spring without the elongation.

## Claims

1. A surgical assembly for treating incontinence comprising: a first surgical instrument for use on a right side of a patient, the first surgical instrument comprising a handle portion and a substantially helical needle portion having substantial structure in three dimensions and a distal end, the needle portion having a portion that is sized and shaped to extend between an incision substantially adjacent the obturator foramen on the patient's right side and a vaginal incision;
a second surgical instrument for use on a left side of a patient, the second surgical instrument comprising a handle portion and a substantially helical needle portion having substantial structure in three dimensions and a distal end, the needle portion having a portion that is sized and shaped to extend between an incision substantially adjacent the obturator foramen on the patient's left side and a vaginal incision; and 
a sling assembly including a mesh material.

2. The assembly of claim 1 wherein the sling assembly comprises a synthetic material.

3. The assembly of claim 1 wherein the sling assembly comprises a knitted polypropylene material.

4. The assembly of claim 1 wherein the sling assembly comprises a sheath.

5. The assembly of claim 1 wherein at least a portion of the sling assembly comprises a non-synthetic material.

6. The assembly of claim 1 wherein the mesh material comprises a woven or knitted material.

7. The assembly of claim 1 wherein the mesh material comprises interlinked fibers that form multiple junctions.

8. The assembly of claim 1 wherein the needle portions of the first and second surgical instruments have structure near the distal ends for associating the first and second surgical instruments with the sling assembly.

9. The assembly of claim 1 wherein the needle portions of the first and second surgical instruments further comprise substantially straight spacer portions along an elongate axis of the handles.

10. The assembly of claim 1 wherein the substantially helical needle portions of the first and second surgical instruments are variable spiral portions.

11. The assembly of claim 1 wherein the needle portions of the first and second surgical instruments include a substantially circular cross sectional shape with a diameter of less than about 4 mm.

12. The surgical assembly of claim 1 wherein the handle portion of the first surgical instrument includes indicia indicating the first surgical instrument is for use on the right side of the patient, and
the handle portion of the second surgical instrument includes indicia indicating the second surgical instrument is for use on the left side of the patient.

13. The assembly of claim 1 wherein the handle portions of the first and second surgical instruments are detachable from the substantially helical needle portions.

14. The assembly of claim 1 wherein the handle portions of the first and second surgical instruments consist of a single handle adapted to removably attach to the substantially helical needle portions of the first and second surgical instruments.

15. A surgical assembly for treating incontinence comprising: a first surgical instrument for use on a right side of a patient, the first surgical instrument comprising a handle portion, and a needle portion having a substantially straight portion projecting from the handle and a variable spiral portion with a distal end, the variable spiral portion being sized and shaped to extend between an incision substantially adjacent the obturator foramen on the patient's right side and a vaginal incision;
a second surgical instrument for use on a left side of a patient, the second surgical instrument comprising a handle portion, and a needle portion having a substantially straight portion projecting from the handle and a variable spiral portion with a distal end, the variable spiral portion being sized and shaped to extend between an incision substantially adjacent the obturator foramen on the patient's left side and a vaginal incision; and 
a sling assembly including a mesh material.

16. The assembly of claim 15 wherein the variable spiral portions of the first and second surgical instruments have a tissue clearance depth of greater than about 1.5 inches and less than about 2.5 inches.

17. The assembly of claim 15 wherein the variable spiral portions of the first and second surgical instruments have a maximum width of greater than about 1.25 inches and less than about 3 inches.

18. A surgical assembly for treating incontinence comprising: a first substantially helical needle having a leading end, a trailing end and substantial structure in three dimensions, the needle having a portion that is sized and shaped to extend between an incision substantially adjacent the obturator foramen on a patient's right side and a vaginal incision;
a second substantially helical needle having a leading end, a trailing end and substantial structure in three dimensions, the needle portion having a portion that is sized and shaped to extend between an incision substantially adjacent the obturator foraxnen on the patient's left side and a vaginal incision; 
a handle removably attachable to the trailing ends of the first and second substantially helical needles; and 
a sling assembly including a mesh material.

19. The surgical assembly of claim 18 wherein the handle is removably attachable to the leading ends of the first and second substantially helical needles.

20. A method of treating incontinence in a patient comprising the steps of:
creating a vaginal incision, 
creating an incision substantially adjacent the patient's obturator foramen, 
providing an elongate, substantially helical surgical instrument comprising first and second ends, with at least one of the ends having a securement surfaces, 
providing a sling assembly having an implantable sling for treating the incontinence, the sling assembly having surfaces complementary to the securement surfaces. 
passing the instrument between the incisions, 
then snap fitting the instrument to the sling assembly to provide a substantially permanent attachment between the instrument and the assembly, 
then passing the implantable material through tissue from the vaginal incision toward the incision substantially adjacent the patient's obturator foramen.

21. A method of treating incontinence in a patient comprising the steps of:
creating a vaginal incision, 
creating an incision substantially adjacent the patient's obturator foranien, 
providing a substantially helical, elongate surgical instrument comprising first and second ends, the instrument having substantial structure in three dimensions, 
providing an implant for treating the incontinence, 
passing the instrument between the incisions, 
then associating the implant with the instrument, and 
passing the implant through tissue and through the patient's obturator foramen with the instrument.

22. A method according to claim 21 wherein the step of passing the implant through tissue includes the step of passing the implant along a substantially three dimensional path.

23. A method according to claim 21 wherein the step of providing an elongate surgical instrument includes the step of providing an instrument with an elongate handle portion having an axis, and
the step of passing the instrument between the incisions includes the step of rotating the instrument about the axis of the handle portion.

24. A method of treating incontinence in a patient comprising the steps of:
creating a vaginal incision, 
creating an incision substantially adjacent the patient's obturator foramen, 
providing an elongate surgical instrument comprising a handle portion,, a needle portion having a substantially straight portion projecting from the handle portion and a variable spiral portion with a distal end, 
providing an implant for treating the incontinence, 
passing at least a portion of the variable spiral portion between the incisions by initially passing the distal end through the incision substantially adjacent the patient's obturator foramen and then through the vaginal incision, 
then associating the implant with a portion of the instrument that has emerged from the vaginal incision, and 
then moving the distal end of the instrument with the implant associated therewith from the vaginal incision toward the patient's obturator foramen to pass the implant through tissue.

25. A method according to claim 24 wherein the step of associating the implant with a portion of the instrument that has emerged from the vaginal incision includes the step of using a suture to tie the implant to an eyelet in the distal end of the needle.

26. A method of treating incontinence in a patient comprising the steps of:
creating a vaginal incision, 
creating an incision substantially adjacent the patient's obturator foramen, 
providing a substantially helical, elongate surgical instrument comprising a pair of ends, 
providing an assembly having an implant for treating incontinence, 
initially passing one end of the instrument initially through the vaginal incision toward the incision substantially adjacent the patient's obturator foramen in a path through the patient's obturator foramen until one end of the instrument emerges from the incision substantially adjacent the patient's obturator foramen, leaving the other end of the needle projecting from the vaginal incision, 
then associating the end of the instrument that projects from the vaginal incision with the assembly, and 
then moving the instrument Out of the patient's body to pass the implant through tissue from the vaginal incision toward the incision substantially adjacent the patient's obturator foramen to place the implant in a therapeutically effective position.