Surgical instrument and tape for treating female urinary incontinence

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DESCRIPTION

Surgical instrument for the treatment of female urinary incontinence.

Background of the invention

The present invention relates generally to a surgical instrument for use in a procedure for the treatment of female urinary incontinence and, in particular, to a conical needle to facilitate the perforation of different layers of tissue, each layer of tissue having a resistance different versus perforation.

Women account for more than 11 million cases of incontinence. In addition, a majority of women with incontinence suffer from stress urinary incontinence (SUI). Women with SUI involuntarily leak urine during normal daily activities and movements, such as laughing, coughing, sneezing, and regular exercise.

SUI can be caused by a functional defect in the tissue or ligaments that connect the wall of the vagina with the pelvic muscles and pubic bone. Common causes include repetitive strain on the pelvic muscles, childbirth, loss of pelvic muscle tone, and loss of estrogen. Such a defect results in an improperly functioning urethra. Unlike other types of incontinence, SUI is not a bladder problem.

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. However, when a woman has the most common form of SUI, the weakened pelvic muscle and tissues cannot 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 maintain its closure, allowing urine to escape. Since SUI is both embarrassing and unpredictable, many women with SUI avoid an active lifestyle, shunning social situations.

US Patent 5,112,344 describes a method and apparatus for treating female incontinence. The surgical instrument for applying a filamentous element to the body comprises a tubular body having a handle at one end and a flexible needle that can be slidably housed in the body and adapted at one end to receive a filamentary element. The procedure to treat female incontinence comprises forming loops in a filamentous element between the wall of the vagina and the abdominal envelope of the rectum on the anterior wall of the abdomen through which it passes on each side of the urethra, tightening the loop to bring the wall of the vagina and urethra into their correct spatial relationship to the pubis allowing the development of scar tissue between the wall of the vagina and the anterior wall of the pubic symphysis of the abdomen and removing the element filamentous.

US Patent 5,899,909 and WO 96/06567 describe surgical instruments comprising a shaft having a handle at one end and connecting means at the other end to house, one at a time, two curved needle-shaped elements. that are connected at one end with one end of a ribbon intended to be implanted in the body. In practice, the tape is passed into the body through the vagina first at one end and then at the other end to one side and the other, respectively, of the urethra to form a loop around the urethra, located between the urethra and the wall of the vagina. The tape is extended over the pubis and through the abdominal wall and is taut. The ends of the tape are cut into the abdominal wall, and the tape is left implanted in the body.

Current ribbon implant needles have a short tapered tip and a curved shaft with a constant diameter. When the tapered tip of the tapered needle pierces a layer of human tissue that has a high resistance to perforation (such as fascia or muscle), the force required is high compared to the force required to pierce human soft tissue ( like fat). To decrease the maximum force required by the surgeon to penetrate the fascia or muscle, the tip of the needle is pointed. However, once the tapered tip passes through a layer of tissue with a high puncture resistance, the force required to further pass the needle through the tissue suddenly drops close to zero. Then, as an undesirable consequence, the needle can penetrate through the tissue more quickly than the surgeon wishes, possibly causing the surgeon to lose control of the needle and risking the possibility of inadvertently piercing other structures of the body, such as , bone, organs or blood vessels, with the pointed tip of the needle.

It would be beneficial to provide a needle for use in implanting a mesh tape into a female body to prevent incontinence that is designed to provide more uniform resistance to piercing different types of tissue.

It would also be beneficial to simplify the design of the surgical instrument to facilitate loading of the tape onto a needle during operation. In this way, the instrument would be more receptive to various types of tapes, such as synthetic cadaveric tissue and genetically engineered tissue.

Summary of the invention

The invention overcomes the shortcomings of the prior art and provides an improved needle for use with an apparatus for the treatment of female stress urinary incontinence. The invention provides an instrument

ES 2 291 202 T3 surgical according to claim 1 which may comprise a handle at one end and connection means at the other end to house, one at a time, two elements in the shape of a curved needle, each having a blunt tip and a variable diameter. Each needle is connected at one end with the separate ends of a tape intended to be implanted within the body. In practice, a first end of the tape is passed, through one of the curved needles, into the body through the vagina on one side of the urethra. The needle and the first end of the tape pass over the pubis and through the abdominal wall. The second needle element connects to the handle and to the second end of the tape. The needle and second end of the tape pass into the body through the vagina on the opposite side of the urethra from the first end of the tape, thus forming a loop or sling around the urethra with the tape. The second end of the tape extends over the pubis and through the abdominal wall. The ends of the tape are cut at the abdominal wall, and the tape is left in the body.

The invention further provides a single curved needle element having a blunt tip and variable diameter and further provides an easy attachment means that allows the surgeon to connect both the first and second ends of the tape to the single needle to perform the procedure. explained above.

The invention still further provides a tape comprising a synthetic mesh in combination with a natural material, whereby the natural material would lodge below the urethra to eliminate possible erosion problems.

In one aspect, the invention provides a needle element having a distal end and a proximal end. The diameter of the needle varies, increasing from the distal end to the proximal end. The distal end further defines a tip that has a blunt end. The proximal end provides a connecting means for the handle.

The object of the invention is to provide a surgical instrument that requires a reduced maximum force to pass the tape through the tissue of the body.

Another object of the invention is to provide a needle that requires a more constant force to pass through body tissue.

An advantage of the invention is that it reduces the risk of perforating other structures in the body.

Another advantage of the invention is that it provides a means of quick connection of the tape to the needle, thus allowing the use of non-synthetic fabric as a support element.

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

Figure 1 is a side view of the needle in one embodiment thereof;

Figure 2a is a side view of two needles and a tape that interconnects the needles;

Figures 2b-d are alternative embodiments of the tape and the connecting means between the tape and the needle;

Figure 3a is a side view of an alternative embodiment of the needle;

Figures 3b-c are an enlarged view of the distal tip of the needle shown in Figure 3a and a means for removably connecting the tape to the needle;

Figures 3d-e are an enlarged view of the distal tip of the needle shown in Figure 3a and an alternative means for removably connecting the tape to the needle;

Figures 3f-g are an enlarged view of the distal tip of the needle shown in Figure 3a and an alternative means for removably connecting the tape to the needle;

Figures 4a-g schematically illustrate various surgical steps of the procedure using two needles according to the invention to treat SUI;

Figure 4h illustrates the final position of the tape within the body before the ends of the tape are cut:

Figures 5a-g schematically illustrate the surgical steps of the procedure using a needle according to the invention to treat SUI: and

Figure 5h illustrates the final position and an alternative embodiment of the tape within the body before the ends of the tape are cut.

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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 the parts illustrated in the accompanying drawings and description, since illustrative embodiments of the invention may be implemented or incorporated into other embodiments, variations and modifications, and can be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions used herein have been chosen for the purpose of describing illustrative embodiments of the present invention.

The application describes an apparatus and procedure for treating SUI. A tape is passed through the pelvic tissue and placed under the urethra, creating a support sling. The tape provides a structural medium for tissue growth and thus provides a newly created body tissue support medium for the urethra. When pressure is exerted on the lower abdomen, such as during a cough or sneeze, the tape provides support to the urethra, allowing it to maintain its closure and preventing unwanted urination.

Referring to Figures 1 and 2, the surgical instrument comprises a needle-shaped element 10 that is attached to a mesh tape 12. Needle element 10 defines a determined radius R to perform the surgical procedure discussed herein. The distal end of needle element 10 terminates in a conical section 14 having a tip 16. Alternative configurations are also possible, such as blade, arrow or bulge shaped tips. Preferably tip 16 is blunt, where tip 16 has a radius of approximately 0.6 millimeters. A blunt tip is preferred as it is less likely to dig into bone or penetrate bladder wall tissue or blood vessel wall tissue, as will be appreciated from the implantation procedure tape as described below.

The proximal end of needle 10 terminates in a fixation segment 20 that is adapted to engage and lock into a handle 21, as described in US Patent No. 5,899,909.

Disposed between tip 14 and segment 20 is a curved body segment 18 having a distal end 17 and a proximal end 19. The shape of the body 18 extends substantially a quarter circle in order to substantially follow the outline of the pubis between the vagina and the abdominal wall. For purposes of the procedure as will be discussed in more detail below, body 18 has a preferred radius R of approximately 106 millimeters. Furthermore, the diameter of segment 18 ranges from a smaller diameter at the distal end 17 to a larger diameter at the proximal end 19. The minimum diameter of the distal end 17 can be as low as 0.5 mm due to the minimal stresses at this point. The minimum diameter diameter of the proximal end 19 is approximately 4 mm. Preferably, the diameter at the proximal end is approximately 6mm, and is continuously reduced to a diameter of approximately 3mm at the distal end 17. This design takes into account that, in the procedure for implanting the tape 12, the bending stresses are lower at the distal end 17, while the bending stresses are greatest at the proximal end 19. In other words, during the procedure, the internal bending moment at the distal end 17 is negligible, while the internal bending moment at the proximal end 19 is substantial. The design is also beneficial because the needle provides tactile feedback to the surgeon as the needle passes through the different layers of tissue, unlike a needle that has a minimal diameter.

An unexpected result of needle 10 having a blunt tip 16 and a body 18 of varying diameter is a reduced maximum force required to pierce a layer of tissue, such as fascia, muscle, fat, and skin. In addition, once the needle tip 16 has passed through a layer of tissue, the force required by the surgeon to continue passage of the needle 10 through the subsequent tissue layer or tissue layers having resistances to lower perforation, it does not decrease precipitously as in the prior art. This is a result of the body 18, which has an increasing diameter from the distal end 17 to the proximal end 19, which has to continue to pass through the tissue, thus requiring a more constant force on the part of the surgeon.

Table 1 compares the force required to penetrate a pig fascia (lateral to the linea alba) between a prior art needle and a needle of the present invention. The prior art needle was characterized as having a constant diameter of 5mm and a needle tip having a radius of 0.2mm. The needle of the present invention was characterized as having a diameter varying from 3mm to 6mm from the distal end to the proximal end of the curved body 18 and a needle tip having a radius of 0.6mm. The fascia was placed in a trial device and each needle pierced the fascia at a 90 ° angle at a speed of 50 mm / min. Table 1 lists the maximum force required to penetrate the test tissue.

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TABLE 1

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The test results indicate that the needle of the present invention reduces the penetration force by 29% over the prior art needle.

Needle 10 is preferably tubular with a circular cross section and is made of a material that is compatible with the human body. It is also preferred that the needle 10 is made of a material that can be sterilized in an autoclave to allow multiple surgical procedures of the needle 10. Preferably, the needle 10 is made of AISI 303 stainless steel. The body surface 18 may be smooth, preferably polished, to facilitate soft tissue penetration. Alternatively, the surface of the needle 10 may have a somewhat rougher surface. A rougher surface would result in additional slight tissue trauma which, in turn, stimulates fibroblast activity around the tape 12.

The needle 10 can be manufactured as a single, continuous unit, or alternatively the curved part 18 can be manufactured separately from the linear part 20. In this way, the two pieces would be fixed using any conventional fixing means, such as, screwing, or other conventional means as known to those skilled in the art.

Referring to Figures 2a-d, tape 12 comprises any tissue-compatible synthetic material, or any natural material, including, but not limited to, autologous tissue, allograft, xenograft, a genetically engineered tissue 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 approximately 1 mm, manufactured by Ethicon, Inc., Somerville, NJ, East USA. material is approved by the US Food and Drug Administration for implantation in the human body. Still another embodiment of the tape 12 is a combination of a synthetic material 11 and a natural material 13 centered between the synthetic material 11 as shown in Figures 2b-c. Still another embodiment of the tape 12 includes a combination of the synthetic material 11 and the natural material 13, whereby the natural material is positioned on or incorporated within a generally central portion of the synthetic material 11. An advantage of the tape configurations is that the natural material 13 is along the central region of the tape 12, so that upon installation of the tape 12, the natural material 13 is positioned below the urethra and Eliminates potential erosion problems at the contact surface of the urethra and the tape. The natural material 13 can be connected to the synthetic material 11 by stitching means, a biocompatible adhesive, cell culture techniques or other known means.

Tape 12 can be in any convenient shape that suits the desired purpose of the invention. An exemplary width is approximately 1 cm and the length would depend on the size of the woman undergoing the procedure. Tape 12 may be single or double ply, generally flat in structure, or tubular (Figure 2d) to provide additional supporting force and a more surface area on which the tissue fibers can be attached. In addition, the tape 12 can be made up of different types of material, such as a bioabsorbable and a non-bioabsorbable material. The tape 12 may also be coated with an antimicrobial additive to prevent or minimize infection and a lubricating coating, eg, a bioabsorbable hydrogel, to facilitate the tape to pass through tissue as discussed below. Preferably, tape 12 is lined with a plastic disposal wrap, such as described in US Patent No. 5,899,909. The tape can also be made of a radiopaque and / or contrasting color to body tissue to allow for future diagnostic visualization.

In one embodiment, the tape 12 may be attached to the needle segment 20 by tying, gluing, or other suitable attachment means. Preferably, a biocompatible heat shrink tube secures the tape 12 on the needle portion 20, Figure 2a. In another embodiment, as shown in Figures 2b-d and 3a-g, needle 10 and tape 12 are confi5

ES 2 291 202 T3 additionally shaped to allow easy attachment and detachment of tape 12 to and from needle 10 by the surgeon during operation. This embodiment allows the use of a single needle for the procedure. This embodiment also allows the use of a tape constructed, at least in part, of natural materials that are otherwise unsuitable in the pre-bonded embodiment, due to the natural material's inability to survive prolonged periods in storage.

In one embodiment, shown in Figures 3a-c, the body 18 provides a notch or slot 40 for slidably accommodating the connecting tabs 32 and 32a that are attached to either end of the tape 12. Preferably, the slot 40 extends through the curved body 18 and is further located at the distal end 17 of the needle 10, so that the tape 12 can be disconnected from the needle 10 immediately after the needle 10 penetrates the wall. abdominal, which is discussed later.

Tab 32 can be constructed from any biocompatible material, such as plastic or metal. The tab 32 can be of any shape, such as a square or arrow shape, as long as the tab 32 can be securely inserted into the notch or slot 40. Figures 3b-c illustrate the tab 32 having two arms 33 and spring 33a, which when inserted into slot 40, expand and securely hold tab 32 within slot 40. Tab 32 may be attached to tape 12 in any number of convenient procedures as discussed above and well known to those skilled in the art.

Figures 3d-e illustrate a slot 40 at two levels, in which the tab 32 slides into the lower level that holds the tab 32 in place. Alternative means of capturing tab 32 are provided within slot 40, as is well known in the art.

Figures 3f-g illustrate an alternative embodiment of attaching the tape 12 to the distal end 17a of the needle 10. A removable blunt tip 16a having a connecting pin 15, secures the distal end 17a via a mounting hole 15a to accept the spike 15. The spike 15 can be securely attached to the hole 15a by compression fit, mating threads, or other convenient attachment methods. The distal end 17a further defines a groove 23 of variable depth to allow the end of the tape 12 connected to the spike 15 to pass from within the hole 15a to the exterior of the needle 10. In conjunction with the embodiment of Figures 3ae, this This embodiment allows the surgeon to attach tape 12 to needle 10 just prior to the surgical procedure. An advantage is the ability to use a tape 12 constructed of, at least in part, a natural material.

As one skilled in the art would appreciate, there are multiple means for removably connecting the tape to the needle. Alternate embodiments would include tying the ends of tape 12 to form a knot and securely inserting the knot into the V-type slit in body 18. Alternatively, a diagonal slit in body 18 could accept tape 12 or a suture thread extending from tape 12.

Figures 4a-g show the surgical procedure for implanting tape 12 using two needles. The figures describe the relevant parts of the lower part of the female abdomen, being the vagina 50, the uterus 52, the urethra 54, the pubic bone 56, the urinary bladder 58 and the abdominal wall 60. The first needle 10a penetrates the wall of the vagina, with an incision first being made in the wall to create a flap of tissue. The needle is attached to the handle 21, and the surgeon guides the needle 10a through the wall of the vagina and through the soft tissue on one side of the urethra 54, then the needle according to Figure 4b is passed near the back. from the pubic bone 56, through additional layers of fat, muscle and fascia, and then through the abdominal wall 60 above the pubic bone 56. An incision may be made through the abdominal wall for the needle to pass through. The handle 21 is disconnected from the needle 10a, figure 4c, and the needle 10a together with the tape 12, are removed from the abdominal wall by means of forceps, figure 4d.

Referring to Figure 4e, needle 10b is now attached to handle 21, and needle 10b is passed through the incision in the vaginal wall guided by the surgeon and through the soft tissue on the side of the urethra. opposite the anterior end of tape 12. Needle 10b passes near the back of the pubic bone, through additional layers of fat, muscle, and fascia, Figure 4f, and then through the abdominal wall above the pubic bone and is removed, figure 4g.

Figures 5a-g illustrate an alternative procedure for implanting tape 12 using a single needle 10. Tape 12 is attached to needle 10 via tab 32 (not shown). The needle 10 penetrates the wall of the vagina, with an incision first being made in the wall to create a flap of tissue. The surgeon guides the needle 10 through the wall of the vagina and through the soft tissue on one side of the urethra 54, the needle according to Figure 5b then being passed near the back of the pubic bone 56, through layers additional fat, muscle, and fascia, and then through the abdominal wall 60 above the pubic bone 56. An incision may be made through the abdominal wall for passage of the distal end 17 therethrough. The needle 10 only continues to pass through the abdominal wall until the barb 32 can be disconnected from the body 18, Figure 5c. To do this, the surgeon simply inserts a narrow instrument into slot 40 to force tab 32 out of slot 40 opposite the side where tab 32 was inserted. Tab 32 can then be cut and tape 12 can be removed from the abdominal wall to allow the surgeon additional length for the procedure. The needle 10 is then withdrawn from the patient along the same path as it entered, but in the opposite direction, Figure 5d. Alternatively, needle 10 can be disconnected from handle 21 and withdrawn through abdominal wall 60 using forceps, as discussed with respect to the two needle procedure.

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Referring to Figure 5e, needle 10 is now attached to the opposite end of tape 12 using connector 32a. The surgeon passes the needle 10 through the incision in the wall of the vagina and through the soft tissue on the side of the urethra opposite the anterior end of the tape 12. The needle 10 passes near the back of the pubic bone, through additional layers of fat, muscle, and fascia, figure 5f, and then through the abdominal wall above the pubic bone. The needle 10 continues to pass through the abdominal wall only until the barb 32a can be disconnected from the body 18, Figure 5g. The tape 12 can be removed from the abdominal wall to allow the surgeon additional length for the procedure. The needle 10 is then withdrawn from the patient along the same path as it entered, but in the opposite direction. Alternatively, needle 10 can be disconnected from handle 21 and withdrawn through abdominal wall 60 using forceps.

Since both procedures can be performed using local anesthesia, the patient can provide feedback to the surgeon once the tape 12 is in place. Normally, the urinary bladder 58 is filled with a liquid, such as water, using a catheter, and the patient is asked to cough. The surgeon can determine the function of the urethra and can adjust the tension of the tape 12, as necessary, by adjusting the ends of the tape 12 located on the outside of the abdomen 60, Figures 4h and 5h. After adjustments, the excess tape is cut at the abdomen and the ends of the tape are clamped inside the abdomen and the abdomen is closed. Also, the incision in the wall of the vagina is closed, whereby the flap of tissue closes the tape between the urethra 54 and the wall of the vagina 50.

Tape 12 is left on the body and forms an artificial ligament attached to the abdominal wall that provides support for the urethra as required in order to restore urinary continence to the patient.

It will be apparent from the foregoing that although particular forms of the invention have been illustrated and described, various modifications can be made without departing from the scope of the invention. Accordingly, it is not intended to limit the invention, except by the appended claims.