WO2007101970A1

WO2007101970A1 - Surgical instrument and use thereof

Info

Publication number: WO2007101970A1
Application number: PCT/GB2006/000804
Authority: WO
Inventors: Rajiv Varma
Original assignee: Rajiv Varma
Priority date: 2006-03-07
Filing date: 2006-03-07
Publication date: 2007-09-13

Abstract

The present application relates to a surgical instrument for use in the treatment of female stress urinary incontinence. More particularly, the invention provides a minimally invasive mechanism for the treatment of female stress urinary incontinence comprising a biocompatible small strip of mesh, two curved needle-like elements which are deployed simultaneously to place the said mesh around the mid-urethra region without any exit points through the skin and without the use of additional anchoring equipments, and a supporting device therefor.

Description

Title: Surgical Instrument and use thereof

Technical Field of the Invention

The present invention relates to a surgical method and related instrument for use in the treatment of female stress urinary incontinence. More particularly, the invention provides a minimally invasive mechanism for the treatment of female stress urinary incontinence comprising a biocompatible smaller strip of mesh, one or two curved needle-like elements which are deployed simultaneously or separately to place the said mesh around the mid-urethra region without any exit points through the skin and without the use of additional anchoring equipments, and supporting device for insertion of mesh inside the female body via vagina.

Background of the Invention

Female stress urinary incontinence, defined as the unintentional loss of urine, is caused by anatomical defect function in the tissues or ligaments connecting the vagina wall with the pelvic muscles and pubic bone. Urinary incontinence not only affects number of female patients worldwide but also disturbs their normal day-to-day lifestyle and social appearances. Such a defect results in an improperly functioning urethra.

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. But during urinary incontinence, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its correct position, permitting urine to escape. Most often, the incontinence occurs during coughing, sneezing, or physical activity in females afflicted with this problem.

Consequently, various approaches have been devised in last few decades to treat this problem. Those skilled in the art will be familiar with approaches ranging from pelvic floor exercises to surgical techniques such as Burch colposuspension in which sutures are placed around the bladder neck and Stamey-type endoscopic procedures in which loop sutures are placed so as to elevate the bladder neck. Anatomically, the term "retropubic space" means that region of the female body that is posterior to the pubic bone (i.e. the region that is posterior to the pubic ramus and pubic symphysis). This is an area of loose connective tissue between the bladder with its related fascia and the pubis. It includes endopelvic fascia. The retropubic space extends upward to the rectus fascia, but does not include the suprapubic area with the rectus fascia itself. The retropubic space does not extend beyond the sacrum. The phrases "space of Retzius" or "cave of Retzius" is also used to describe portions of the retropubic space.

The term "endopelvic fascia" means tissue that covers the pelvic organs and surrounds vessels and nerves in the pelvic region (e.g. in the subperitoneal space). Endopelvic fascia includes collagen, elastin and smooth muscle. These structures surround and support the viscera in the pelvic cavity and extend from the pelvic floor to the rectus fascia and respiratory diaphragm. As used herein, endopelvic fascia can include pubocervical fascia and periurethral fascia. Endopelvic fascia is also referred to as visceral pelvic fascia.

The term "pubocervical fascia" means a sheet of thick fibrous tissue that is located on the vagina underneath the bladder. Pubocervical fascia is anterior vaginal fascia that fuses with vaginal tissue, providing a hammock for the urethra and bladder. Proximally, the pubocervical fascia attaches to the cervix; distally it extends beneath the urethra and fuses with the perineal membrane of the ureogenital triangle; and laterally, it is connected to the pelvic wall at the fascial white line (arcus tendineus fasciae pelvis). The pubocervical fascia forms a horizontal platform that supports the bladder, and its anterior portion supports the urethra. With increased abdominal pressure, the lower urinary tract is forced inferiorly and compressed against the pubocervical fascia while this fascial layer displaces to a lesser degree because of its elastic suspensory characteristics.

The use of sling to correct stress urinary incontinence has existed since the late 1990's. Understanding of the physiopathological concepts of female stress urinary incontinence (SUI) has consistently improved over the past decades and their application has lead to the development of numerous surgical techniques aimed at curing this disorder. US Patent No. 5,112,344 discloses a method for treating female urinary incontinence without the necessity of opening the abdomen, which would require hospital care for may be four days. In this method a filamentary element (or mesh tape) is looped around the muscle tissue of the abdomen to either side of urethra to be implanted into the soft tissue between the vaginal wall and the abdominal wall extending over pubis and with the ends of the tape extending into vagina. The tape is left in the body in order that fibrous tissue shall develop around the tape, said scar tissue functioning as a supporting ligament in the soft tissue. The tape is removed from the body when such scar tissue has developed, which may take about two months.

A surgical instrument of special construction is also proposed for use with this method, comprising a shank having a handle at one end thereof and a curved portion at the other end thereof said portion being intended to be passed into the body via the vagina. The results obtained by such surgery are not always satisfactory due to the fact that fibrous tissue does not develop sufficiently since the soft tissue between the vaginal wall and the abdominal wall are in poor condition.

Another US Patent No. 5,899,909 discloses a surgical instrument comprising a shank having a handle at one end and connecting means at the other ends to receive, one at a time, two curved needle-like elements which are connected at one end to one end of a mesh intended to be implanted into the body. In practice, a tape-free end of one of the needle-like elements is inserted through the vaginal incision and into the paraurethral space, through the rectus sheath and out through the lower anterior abdominal wall. Using a handle attached to the needle, the needle is angulated laterally (for example, to the right) to perforate the endopelvic fascia, guided through the retropubic space and passed through the abdominal incision. The handle is disconnected and the needle is then withdrawn through the abdominal wall, thereby threading a portion of the tape through the tissue of the patient. This technique is repeated with the other needle on the other side (for example, to the left), so that the tape is looped beneath the bladder neck or urethra. The tape is adjusted to provide appropriate support to the bladder neck or urethra. The tape ends are then cut at the abdominal wall leaving the ends of the sling anchored in the abdominal (rectus) fascia.

This trans-vaginal procedure is exemplified by the TVT product sold by Gynecare franchise of Ethicon Inc, a Johnson & Johnson Co., of Somerville, NJ., USA. It has been suggested that retro-pubic TVT may stabilize the mid-urethra at the time of an abdominal pressure increase without modifying cervico-urethral mobility. The procedure relies on tightening of the tape around the urethra. The mesh itself provides a "velcro-like" effect within the pelvic musculature to hold the mesh in place while the scar tissue forms. A resulting over tightening may result in de novo urgency. This and similar procedures similar to this also have the risk of bladder injury due to the passage of this rather large mesh into the abdominal wall.

Over the past 4-6 years, there have been several variations to this procedure using the same overall principle. There has been an abdominal approach where the needles essentially start from the abdomen and then exit into the mid-urethral space. The use of retro-pubic TVT and the abdominal approach have been associated with various and relatively frequent peri- and post-operative complications, including bladder perforation, temporary or persistent retention, pain, urinary infection, and de novo urgency. Other rare but severe and possibly underestimated complications have been reported with this approach. Indeed, the blind passage of the needle in the retro- pubic space can result in injuries to other organs than the bladder, in particular the urethra, vessels, nerves and bowel. To avoid these complications, alternate approaches with a pre-pubic or transobturator passage of the tape have been developed and continence rates obtained with these routes have been roughly similar to those after the 'classic' retro-pubic TVT. In the transobturator technique described by Delorme et al., Prog. Urol., 11:1306-13, 2001, the tape is inserted through the obturator foramens from outside to inside (in extension from the thigh folds towards underneath the urethra). Such an approach completely bypasses the risk to the bladder but introduces another potential risk to the obturator bundles. Even though the transobturator outside-in TVT technique is claimed to be a safe procedure, it may occasion urethra and bladder injuries, as reported by Hermieu et al., Prog. Urol, 13:115-117, 2003.

Similarly, De Leval (US 2004/0097974 Al) describes a surgical technique for the treatment of female stress urinary incontinence, in which the posterior urethra is supported using a tape passed through the obturator orifices from inside (underneath the urethra) to outside (thigh folds). In practice, an incision is made of the vaginal wall, a pare-urethral dissection towards the ischio pubic ramus is performed while avoiding a perforation of the vaginal wall. A surgical needle is rotated around the ischio pubic ramus, and exits from a previously identified surgical exit point. An outside in approach is roughly performed in the opposite manner. This procedure may be safer than the outside-in obturator approach but still carries the risk of injury to the obturator bundles if not done correctly. Moreover, due to the exit of the needles into the thigh folds, this procedure results in transient pain as a side effect. Further more, the obturator approach also uses the "Velcro-like" effect within the obturator musculature to hold the tape under the urethra.

More recently, there have been other approaches where the product does not exit the skin at all. These approaches use "anchors" within key anatomical locations within the pelvic floor to achieve fixation of the mesh. For example, Neisz et. al., (US2002/0161382) describe placement of the mesh using anchors or anchor like materials into the retropubic space. Ulmsten et al., (US2002/ 0128670) describes bonding of the ends of the tape to tissue within the pubic bone. Browning (WO2004/004600) also describes the use of an anchor. Finally, Carter et. al (WO2003/028584) describes an anchor patch used within a space of Retzius. The common elements of these approaches are the use of an anchor for anchoring into a fixed anatomical location such as the retropubic space or the space of Retzius. Such approaches require the use of an anchor, which introduces another "foreign-body" and could result in complications.

Anchors and/or the "Velcro-like" effect are deemed necessary to keep the mesh in place while tissue in-growth occurs and a scar forms under the urethra. There is conventional wisdom that the mesh may be dislodged or move out of place if not attached. Recently Carey (WO 2004/045457) described a method for pelvic floor repair that uses a large mesh without anchors. Carey teaches that the mesh can be kept in-place while the tissue in-growth occurs using a pessary or a splint without the need for anchoring.

The use of synthetic mesh for stress urinary incontinence has been controversial in the past but is now well accepted as the gold standard of treatment. The mesh has its effects by causing scar tissue to form under and around the urethra. In all of the current teachings, however, the mesh itself extends beyond the urethra into the retropubic space, the obturator space and/or the abdomen. Some literature also talks about the use of natural meshes or use of synthetic absorbable meshes under the urethra. For example, Trabucco (US Patent 6,306,079) describes the use of combination mesh with an absorbable component under the urethra. The use of absorbable and synthetic meshes for the treatment of female stress urinary incontinence is controversial at best. However, it is also well recognized that the amount of foreign material or implant left within the body should be minimized as much as possible.

No known references teaches or enables the methods of the present invention comprising of minimally invasive surgical instrument useful for the treatment of female urinary incontinence avoiding adverse effects associated with conventional procedures; nor do the published references alone or in combination suggest these methods.

The present invention is novel and relates to use of a surgical instrument for treatment of female urinary incontinence.

Summary of the Invention

The present invention relates to a method and related surgical instrument for use in the treatment of female stress urinary incontinence. More particularly, the present invention provides a safe, effective and minimally invasive surgical procedure for deploying and implanting a biocompatible smaller strip of mesh inside the female body around the mid- urethra region without the additional use of anchoring equipments and without exit points through the skin. The surgical procedure can be suitably carried out under local anesthesia in the office setting or an operating room suite.

In one aspect of the invention, a surgical instrument comprises a biocompatible and a smaller strip of mesh to be implanted in vivo, two curved needle-like elements to be deployed simultaneously or separately for the said mesh to be placed around the mid- urethral region and supporting device for insertion of mesh and needle-like element assembly in vivo via female vagina.

In another aspect of the invention, a surgical instrument includes a biocompatible and smaller strip of mesh of polypropylene, optionally a removable protective sleeve designed to assist deployment of the mesh into the body, and two curved needle-like element having upwardly directional projections or hooks for easy deployment of the said mesh around the mid-urethra region. The sleeve is optional. The sleeve can be made of soluble material which dissolves as the needles are inserted and kept in the body for short time.

In yet another aspect of the invention, the mesh is between 0.1cm to 0.8cm in width and 3 cm to 10 cm in length and placed under the urethra without the need of additional anchoring equipments and with or without the need for a pessary or splint in the vagina.

In yet another aspect of the invention, two curved needle-like elements are positioned at a predetermined angle to the horizontal, to be inserted into a cut made in the vagina at the mid-urethra. One end of each needle-like element is coupled with supporting device and other end is intended to pass into the body via the female vagina.

In yet another aspect of the invention, the needle-like elements can be curved parallel to each other to form U-shaped profile to be inserted in the direction of the pubic bone or obturator foramen or area in between around the mid-urethra region. In yet another aspect of the invention, the needle-like elements can be curved into a V- shape profile to be inserted in the direction of the pubic bone or obturator foramen or area in between around the mid-urethra region.

In yet another aspect of the invention, the needle-like elements can be straight, curved or made of shape memory alloy, which can change its shape as the needle-like elements are deployed.

In yet another aspect of the invention, the supporting device has mechanism to protect the urethra as the needles are deployed.

In yet another aspect of the invention, provide a supporting device, which may or may not be automated to deploy the needles simultaneously or separately.

According to yet another aspect of the invention, a method for mechanically or automatically deploying biocompatible smaller strip of mesh around the mid-urethral region for the treatment of the female urinary incontinence is provided.

Other aspects of the invention will be apparent to those skilled in the art in view of the appended claims and given description.

Brief Description of Drawings

Fig. 1 is example embodiment of needle with hooks/ projections and a piece of mesh

Fig.2 is example embodiment of the a mesh mounted on a needle

Fig. 3 is example embodiment of mesh wrapped around needle assembly and held by hooks. The figure also shows the one of the two sleeves and placement of the sleeve on the needle.

Fig.4 is example embodiment of needle with plurality of holes and illustrates a mesh placed around the needles

Fig. 5 is example embodiment of an alternative method of holding and selectively releasing the mesh. Fig. 6 illustrates an example embodiment of supporting device for placing the mesh

Fig 7 illustrates an example embodiment of supporting device and the mesh mounted on the said supporting device.

Fig 8 illustrates an example embodiment of the procedure of placing the mesh in female body

Fig 9 illustrates how the mesh is placed in the body

Fig 10 illustrates and example embodiment of a manual device to place a mesh in female body.

Detailed Description of Exemplary Embodiments

Method of treating female stress urinary incontinence is disclosed where in as shown in FIG 9, a smaller strip of mesh 100 is implanted in the body 137 through a incision on anterior vaginal wall 136 and placed in the mid-urethral region between vaginal facia and urethra and pointing upwards. The mesh can be placed pointing to retropubic space or obturator foramen or in between. In fig 9 it is shown pointing towards the retropubic space. In this novel approach, there are no anchors used to hold the mesh is place. Also, in this approach, the mesh is of small enough size not to require any exit points. The mesh is left in the body and it produces scar tissue which makes the female continent.

To assist in the procedure above, a surgical instrument is devised to be inserted in vivo via female vagina and positioned in the vicinity of mid-urethral region for deploying and implanting biocompatible smaller strip of mesh (hereinafter referred as "Mesh" or "mesh") 100 optionally covered by removable protective sleeve 108 without the use of external anchoring equipments. The mesh 100 width can range from 0.1 cm to 0.8 cm with length ranging from 1 cm to 10 cm, preferable size is 0.3 cm to 0.6cm in width and 5cm to 6 cm in length.

In one embodiment of the invention, the curved needle-like elements (hereinafter referred as "Needle" or "needle") 102 made of rigid or semi-rigid material has projections 104 which point upwards, towards the tip or outwards, away from the center as illustrated in Fig. 3. Mesh 100 is wrapped around the needle 102 and held in place by the hooks 104 as illustrated in Fig. 2. Optionally, as shown in figure 3, a sleeve 108, which can be made of rigid, semi-rigid or thin material, encloses the mesh 100. The material of the sleeve 108 can be biocompatible polymer or metals like stainless steel. The novel concept of the sleeve 108 provides low friction when the device is inserted into the tissue. The sleeve 108 can be ripped off or slide back while deploying the mesh. The assembly of needle 102, mesh 100 and optional sleeve 108, is inserted into the predefined anatomical space. Once the assembly is in right position, the sleeve 108 can be removed from the mesh, if the sleeve 108 exists on the instrument. This exposes the mesh 100, which comes in contact with the tissue. The hooks 104 help to keep the mesh in place while the instrument is inserted. The specific direction of hooks 104 releases the mesh 100 while the needle 102 is pulled out. As the friction between mesh 100 and tissue is more than the mesh 100 and needle 102, it prevents major movement of mesh 100 when the needle 102 is pulled out, placing mesh 100 in desired place in a desired manner.

A modified embodiment of the invention, mesh is selectively released by using string 114, which passes through plurality of holes 112 made on the needle 102 and holds the mesh 100 in place as illustrated in Fig.4. Alternatively as shown in fig 5 the string 114 can hold only at the distal end through the holes 109 provided at the distal end of the needle 102. As the string 114 is pulled out, the mesh 100 becomes free and is deployed.

Another slight modification in the embodiment of the invention illustrated in Fig 5, the mesh 100 is held in place on the needle 102 by using dissolving adhesive. When the adhesive comes in contact with the body fluids, it will get dissolved leaving the mesh 100 in the tissue. Here the use of string 114 is eliminated. The dissolving adhesive can be like a dissolving sleeve made of gelatin or other such material.

Yet another embodiment of the invention, mesh 100 is selectively releases using a device 120 in the form of medical stapler or gun or any other appropriate resembling shape. Fig. 6 and Fig. 7 exemplifies a device 120 having a gear mechanism or such mechanical force transmitting mechanism 124, which allows the needles 102 to be deployed as desired. The device 120 has a mechanical trigger 122 or other power source 124 to move said mechanism to deploy the mesh 100 and needle 102. As illustrated in Fig 8, the device has optional urethral probe 128 which guides the device and also prevents any damage to the tissue when the needles 102 are deployed. The fire the device 120, the vaginal probe 126 of the device is placed in the female vagina 136, the probe 128 is inserted into the urethra 135. When the trigger 122 is pulled in, it moves the gear train 124, which in turn ejects the needle 102 out of the vaginal probe 126. The needle 102 then travels into the tissue at a predetermined angle. The needle 102 can be made to travel either in direction of retro pubic space or obturator foramen or in between. The needle 102 can be made of memory retaining material (or shape memory alloy) like Nitinol or biomedical grade polymer or biomedical grade metal. When the trigger is pulled or the powering mechanism activated, the needle 102 assembly is pushed out. This assembly then travels through the predetermined direction in the tissue. When the trigger is released, the sleeve 108 shown in Fig 7 will be retracted in the device 120, exposing the mesh 100 to the surrounding tissue. When the handle is pulled back again, the needle 102 is withdrawn leaving the mesh 100 in tissue.

In slightly modified embodiment, the needle 102, mesh 100 and optional sleeve 108 assembly is deployed in the tissue when the trigger or powering mechanism 124 is pulled and later when released, the sleeve 108 retracts first and then the needle 102 retract in the same stroke.

In another modified embodiment as illustrated in Fig. 6 and Fig. 7, an optional urethral probe 128 is inserted into the urethra before deploying the device, to prevent the puncture during deployment of needle 102. Another way of preventing the urethra from getting accidentally punctured, an anvil as shown in Fig 10 is provided on the vaginal probe, which rests against the urethra and prevents the needle 102 from accidentally puncturing the urethra.

In another embodiment as illustrated in Fig 10, pushing the manual slider 145 deploys the needles. The device 140 houses the slider, the needles, mesh and optional sleeve and optional urethral probe. When the slider 145 is pushed, the needles 102 are deployed in the body. The slider can also be used to slide back the needles to deploy the mesh. While the invention has been described in conjunction with several specific embodiments, it is to be understood that many alternatives, modifications and variations will be apparent to those skilled in the art in light of the forgoing description. Accordingly, this invention is intended to embrace all such alternatives, modifications and variations, which fall within the spirit and scope of the appended claims.

Claims

ClaimsWhat I claim is -

1. A minimally invasive surgical procedure for treating female stress urinary incontinence comprising a biocompatible smaller strip of mesh wherein the said mesh is implanted inside the female body without skin exit points around the mid- urethra region without the use of external anchoring equipments, and a surgical instrument for deploying the said mesh.

2. The surgical procedure of claim 1, wherein the said mesh size is in the range of 0.1cm to 0.8cm in width and lcm to 10 cm in length.

3. The surgical procedure of claim 1, wherein the said mesh provides support to the urethra.

4. The surgical procedure of claim 1, wherein the said mesh can be deployed simultaneously or separately into the body.

5. The surgical procedure of claim 1 further comprises an optional pessary-like device placed in the vagina to hold the said mesh in place while tissue in-growth is occurring.

6. A surgical instrument of claim 1, wherein the said instrument is inserted in vivo via female vagina and positioned in the vicinity of mid-urethral region without the use of external anchoring equipments comprising: i) a biocompatible smaller strip of mesh; ii) two curved needle-like elements; iii) an optional removable sleeve for covering the said mesh; iv) a supporting device wherein the one end of said elements is coupled with the said supporting device at a predetermined angle ranging from and v) an optional mechanism to protect the urethra while the said mesh is being deployed.

7. The instrument of claim 6, wherein the said instrument is inserted in the direction of retro pubic space or obturator foramen or in between.

8. The instrument of claim 6, wherein the said elements is curved parallel to each other to form U-shape profile.

9. The instrument of claim 6, wherein the said elements is curved to form V-shape profile.

10. The instrument of claim 6, wherein the said elements is made of shape memory alloy.

11. The instrument of claim 6, wherein the said removable sleeve is made of rigid, semi-rigid, thin material or biocompatible polymer or metals.

12. The instrument of claim 11, wherein the said sleeve provides low friction when the said instrument is inserted inside the body.

13. The instrument of claim 6, wherein the said sleeve is ripped off or slide back while deploying the said mesh.

14. The instrument of claim 6, wherein the said mesh is wrapped around the said elements.

15. The instrument of claim 6, wherein the said elements have upwardly directional hooks for holding the said mesh in place.

16. The instrument of claim 6, wherein the said elements have string passing through plurality of holes for selectively releasing the said mesh.

17. The instrument of claim 6, wherein the said elements have retractable hooks for deploying the said mesh.

18. The instrument of claim 6, wherein the said mesh is attached to the said elements by dissolving adhesive.

19. The instrument of claim 18, wherein the said adhesive is in the form of dissolving sleeve made of gelatin or such like.

20. The instrument of claim 6, wherein the said supporting device is use for deploying the said elements and selectively releasing the said mesh.

21. The instrument of claim 20, wherein the said device is operated manually or automatically.

22. The instrument of claim 20, wherein the said device have gear mechanism or mechanical force transmitting mechanism coupled with trigger or power source to move the said mechanism for deploying the said elements when trigger or power source is activated.

23. The instrument of claim 20, wherein the said device have vaginal probe to be inserted into vagina and optional urethral probe to be inserted into urethra.

24. The instrument of claim 23, wherein the said urethral probe is used to prevent urethra from getting puncture during deployment of said elements.

25. Use of surgical instrument of claim 6 for treatment of female stress urinary incontinence without the use of external anchoring equipments comprises the steps of - i. passing the said instrument into the female body via vagina; ii. positioning the said mesh around the mid-urethral region; iii. removing the said optional sleeve from the said mesh; and iv. leaving the said mesh implanted in the female body by withdrawing the said instrument from female body.