WO2012054985A1

WO2012054985A1 - Method and devices for repair of vaginal wall or uterus

Info

Publication number: WO2012054985A1
Application number: PCT/AU2011/001385
Authority: WO
Inventors: Marcus Patrick Carey
Original assignee: Carey Tasca Pty Ltd
Priority date: 2010-10-29
Filing date: 2011-10-28
Publication date: 2012-05-03

Abstract

A method for repairing a vaginal wall damaged by pelvic organ prolapse includes forming an access opening to provide abdominal access to the vaginal apex and introducing a reinforcing implant, having a body and a tongue, through the access opening and positioning the body of the reinforcing implant over a portion of the vaginal wall for repair. At least a portion of the body of the reinforcing implant is attached to the vaginal wall and the tongue of the reinforcing implant is positioned anterior to the sacrum. Placement of the reinforcing implant is stabilized for a duration sufficient to achieve tissue in-growth into the reinforcing implant. The method may also be used to repair the uterus and may be performed using a variety of techniques. The invention also relates to a reinforcing implant for use during the repair of the vagina or uterus, and a splinting appliance therefor.

Description

METHOD AND DEVICES FOR REPAIR OF VAGINAL WALL OR UTERUS

Field of the Invention

This invention relates to a method for surgical repair of a vaginal wall or uterus. It relates particularly but not exclusively to a method performed by laparoscopy or other minimally invasive technique and to devices such as an elevator device and a splinting apparatus for use during the surgery and during initial convalescence of the woman undergoing treatment. Background to the Invention

Vaginal prolapse is a condition in which the bladder, uterus and/or bowel protrude into the vagina, typically due to loss of natural support for the pelvic organs and the vaginal vault in women who have undergone a prior hysterectomy. In the normal female anatomy, direct support for the vaginal vault is provided by the parametrium (cardinal and uterosacral ligaments) and paracolpium fibers. These fibers act like suspensory ligaments and arise from the fascia of the piriformis muscle, sacroiliac joint and lateral sacrum, and insert into the lateral upper third of the vagina. Indirect support for the vaginal vault is provided by the levator plate, formed by the fusion of the right and left levator ani muscles between the rectum and coccyx. Pelvic organ prolapse and vaginal vault prolapse occurs after failure of these direct and indirect supporting mechanisms and is frequently accompanied by weakness of the muscular pelvic floor and suspensory fibers of the parametrium and upper paracolpium. Vaginal vault prolapse occurs in approximately 10% of women following hysterectomy and occurs in equal numbers following abdominal and vaginal hysterectomy.

Traditional surgery for repair of pelvic organ prolapse involves making incisions in the vaginal wall and strengthening the fascial tissues with stitches to reinforce the repair. This vaginal repair approach has a high failure rate with around 30% of women surgically treated for prolapse requiring repeat surgery for recurrent pelvic floor symptom. Women aged less than 60 years and women with stages 3 and 4 prolapse are more likely to experience recurrent prolapse after vaginal repair. Abdominal sacral colpopexy (ASC) is a procedure that was developed to address the high rate of failure with vaginal surgery to treat vaginal vault prolapse. ASC employs retroperitoneal interposition of a suspensory prosthesis (typically a mesh) between the vaginal apex and the sacrum. In addition to the high success rate reported with the ACS procedure, other advantages include preservation of vaginal capacity resulting in maintenance of coital function. Significant problems associated with the ASC operation include de novo postoperative stress incontinence, intraoperative hemorrhage, dyspareunia and vaginal mesh exposure. Use of a laparotomy incision brings with it risk of infection and long recovery time.

The use of laparoscopy to treat pelvic organ prolapse has steadily increased over the past 30 years. Laparoscopic sacrocolpopexy (LSC) is performed in an identical manner to ASC with the only difference being the smaller laparoscopic incisions which avoid a major laparotomy incision. Thus, LSC is associated with less postoperative pain, shorter hospital stay, and a quicker return to normal activities. However, current methods of LSC require a high level of laparoscopic surgical skill and expertise. Thus, use of laparoscopy for the treatment of pelvic organ prolapse has been limited to a relatively small number of surgeons with sufficient laparoscopic and reconstructive pelvic surgical skills to perform these procedures safely and effectively.

It would be desirable to provide an alternative method of vaginal wall repair which overcomes or at least ameliorates one or more of the disadvantages of the prior art.

The discussion of the background to the invention included herein including reference to documents, acts, materials, devices, articles and the like is intended to explain the context of the present invention. This is not to be taken as an admission or a suggestion that any of the material referred to was published, known or part of the common general knowledge in Australia as at the priority date of any of the claims. Summary of the Invention

According to a first aspect of the present invention, there is provided a method for repairing a vaginal wall damaged by pelvic organ prolapse, including the steps of: (a) forming an access opening to provide abdominal access to the vaginal apex; (b) introducing a reinforcing implant, having a body and a tongue, through the access opening and positioning the body of the reinforcing implant over a portion of the vaginal wall for repair;

(c) attaching at least a portion of the body of the reinforcing implant to the vaginal wall;

(d) positioning the tongue of the reinforcing implant anterior to the sacrum; and

(e) stabilizing the placement of the reinforcing implant in situ for a duration sufficient to achieve tissue in-growth into the reinforcing implant.

In this description of the invention including the claims, the term "vaginal wall" is intended to include either the anterior vaginal wall or the posterior vaginal wall, or both the anterior vaginal wall and posterior vaginal wall, and includes the vaginal apex (vaginal vault), or part of any of the foregoing.

The method may be modified to repair prolapse of the uterus. Thus, in another aspect of the present invention, there is provided a method for repairing a uterus damaged by pelvic organ prolapse, including the steps of:

(a) forming an access opening to provide abdominal access to the uterus;

(b) introducing a reinforcing implant, having a body and a tongue, through the access opening and positioning the body of the reinforcing implant over a portion of the uterus for repair;

(c) attaching at least a portion of the body of the reinforcing implant to one or both of the uterus and the vaginal wall;

Various features, alternatives and advantages of the inventive methods are possible, many of which will now be described. It is to be understood that these features, alternatives and advantages may be combined with either or both inventive methods such that they relate to repair of the vaginal wall and/or the uterus.

The reinforcing implant may be xenograft material (such as a pig dermis), an allograft or a homograft of skin, or a synthetic material such as a monofilament polypropylene knitting. In a preferred embodiment, the reinforcing implant is a synthetic bio-compatible implant having a braided, porous, laser-cut, woven and/or mesh-like construction with a plurality of openings facilitating tissue in-growth. The openings may be pits formed in the surfaces of the body and/or tongue of the reinforcing implant into which tissue in-growth is desirable, or the openings may be through-holes. Preferably the reinforcing implant has a periphery which is laser cut.

Preferably, there is substantially tensionless placement of the reinforcing implant prior to tissue in-growth. That is, the reinforcing implant is not in tension immediately following it's positioning. It is desirable to avoid use of sutures, anchors, clips, staples or other fasteners to maintain the position of the tongue of the reinforcing implant anterior to or in contact with the sacrum. Instead, it is desirable to stabilize placement of the reinforcing implant by locating a vaginal splinting appliance in the vaginal canal for a duration sufficient to achieve tissue in-growth into the reinforcing implant. In one embodiment, ideal placement is with the tongue of the reinforcing implant resting along the anterior curvature of the sacral hollow and/or sacral promontory. A biocompatible resorbable adhesive may be used to assist with and/or stabilize placement prior to tissue in-growth. The vaginal splinting appliance is preferably manufactured from a semi-rigid, biocompatible and non-reactive material such as medical grade silicon or polyvinyl chloride (PVC) or other suitable polymer. Preferably, the vaginal splinting appliance is secured in position e.g. by placing a suture in each of the left and right vaginal walls, for the duration sufficient to achieve tissue in-growth, after which time the vaginal splinting appliance is removed. Tissue in-growth may be achieved in 20 to 30 days although it is typical for satisfactory in-growth to have occurred within 22 to 27 days of implantation of the reinforcing implant. Most desirably, the vaginal splinting appliance is removed about 25 days after implantation where, in most cases, tissue in-growth sufficient to resist reinforcing implant pull-out has been achieved. In one embodiment, the method includes, prior to attaching the body of reinforcing implant to the vaginal wall, elevating the vaginal vault to facilitate location of the vaginal apex. This assists with positioning the reinforcing implant prior to attaching at least a portion of the body of the reinforcing implant to the vaginal wall. Vaginal wall elevation may be achieved using a vaginal elevator device inserted into the vaginal canal. Preferably, the vaginal elevator device is couplable with a vaginal splinting appliance which is also inserted into the vaginal canal and assists in locating the vaginal apex.

In one embodiment, the method includes forming an opening in the peritoneum anterior to the sacral promontory, and locating a portion of the implant tongue within the opening. The opening may be an incision or a cavity formed in the pre-sacral space between the peritoneum and the sacral promontory. The end of the tongue of the reinforcing implant may include a widened portion, a barb, lateral projection or other feature which substantially limits retraction of the tongue from the opening. Alternatively, the tongue of the reinforcing implant may simply rest in contact with the peritoneum of the sacral hollow and/or sacral promontory and become fixed in that position after tissue in-growth has occurred. This latter approach avoids forming an opening in the peritoneum.

Where a peritoneal opening is used, it is preferred that the opening is formed by creating a first peritoneal opening anterior to the sacral promontory; and forming a tunnel from the first peritoneal opening into the pre-sacral space, wherein the tunnel receives at least a portion of the tongue of the reinforcing implant in the region of the sacral curve. Forming the opening may further include creating a second peritoneal opening, preferably below the first peritoneal opening, and extending the tunnel to the second peritoneal opening. Thus, the tunnel is formed between the peritoneal openings, in the pre-sacral space between the peritoneum and the sacrum. Preferably, each peritoneal opening is a transverse incision in the midline allowing entry into the pre-sacral space. The transverse incisions may have a length of 1 to 3 cm, preferably 1 .5 to 2.5 cm and more preferably 1 .5 to 2 cm. In one embodiment, the tongue of the reinforcing implant is drawn through the tunnel until at least a portion of the tongue of the reinforcing implant rests superior to the peritoneal openings and in abutment with the anterior longitudinal ligament. The method may be used to repair the anterior, posterior or both anterior and posterior vaginal walls. The method may also be used to repair the vaginal apex (vaginal vault). The method may also be used to repair the vaginal apex (vaginal vault) after concomitant hysterectomy or sub-total hysterectomy. The method may be used to repair prolapse of the uterus in women wishing to retain their uterus.

When the vaginal wall being repaired is the posterior vaginal wall, a posterior arm of the body of the reinforcing implant is typically positioned onto an upper portion of the posterior vaginal wall and is attached to the vaginal wall, preferably by tacking with a single resorbable suture placed laparoscopically. When the vaginal wall being repaired is the anterior vaginal wall, an anterior arm of the body of the reinforcing implant is typically positioned onto an upper portion of the anterior vaginal wall and is attached to the vaginal wall, preferably using a single resorbable suture placed laparoscopically. When the prolapsed uterus is being repaired, a posterior arm of the body of the reinforcing implant is typically positioned onto an upper portion of the posterior vaginal wall and in contact with the supra-vaginal portion of the posterior cervix and is attached to the posterior cervix at this level, preferably by tacking with a single resorbable suture placed laparoscopically. However, in some surgeries it may be desirable to attach an arm of the body of the reinforcing implant to part of the uterus only, typically the lower portion of the uterus, without attachment to the vaginal wall. This may be desirable e.g. if a repair to the uterus is performed abdominally while a repair to the vaginal walls is being performed in a vaginal surgery. Whether the repair is to the vaginal wall (or apex) or the uterus, the single suture attaching the anterior or posterior arm of the body of the reinforcing implant may be replaced with one or more staples, clips, tacks or fasteners. When attaching to the vaginal wall, the fastener may be placed vaginally. When placed vaginally the fastener need not be resorbable (although it may be) and may be removed once tissue in-growth has occurred.

Preferably, the method is performed using minimally invasive surgical techniques, such as by laparoscopy. The method may be performed, at least in part using robotic surgical techniques or by laparotomy. Forming the access opening may further involve separating at least a portion of the posterior and/or anterior vaginal wall from surrounding pelvic organ tissue to facilitate positioning the body of the reinforcing implant on the anterior and/or posterior vaginal wall. In women with the uterus present, concomitant hysterectomy or sub-total hysterectomy may be performed prior to the steps of the inventive method. In women with the uterus present and wanting preservation of the uterus, forming the access opening may further involve separating at least a portion of the posterior vaginal wall from surrounding pelvic organ tissue to facilitate positioning the body of the reinforcing implant on the posterior vaginal wall and posterior cervix.

In accordance with another aspect of the present invention, there is provided a software program product embodying instructions for controlling a robotic surgical apparatus performing steps in a method described in the foregoing.

In accordance with another aspect of the present invention still, there is provided a software program product embodying instructions for providing an interface between a user and a robotic surgery control system with which a user plans or executes a robotic surgery according to a method described in the foregoing.

In accordance with a further aspect of the present invention, there is provided a reinforcing implant for use in vaginal wall repair, the reinforcing implant having a tongue and a body, the body having first and second arms for supporting the anterior and posterior vaginal walls respectively, the first and second arms joining the tongue at a reinforcing implant apex; wherein the tongue has a length sufficient to rest within at least a portion of the curvature of the sacral hollow when in situ in a female subject.

In accordance with another embodiment of the present invention, there is provided a reinforcing implant for repair of the uterus, the reinforcing implant having a tongue and a body, the body having first and second arms for supporting the anterior and posterior walls of one or both of the uterus and vagina, the first and second arms joining the tongue at a reinforcing implant apex; wherein the tongue has a length sufficient to rest within at least a portion of the curvature of the sacral hollow when in situ in a female subject.

The reinforcing implant tongue may have a length of e.g. 4 to 25 cm although lengths of 7 to 20 cm are more preferable. For most women, a reinforcing implant having a tongue of 9 to 13 cm in length is considered suitable.

In one embodiment, at least a portion of a surface of the first and second arms facing away from the vaginal wall or uterus when implanted have anti-adhesion properties. A portion of a surface of the tongue may also possess anti-adhesion properties. Preferably, the reinforcing implant is a synthetic, bio-compatible implant having a braided, porous, laser-cut, woven and/or mesh-like construction with a plurality of openings facilitating tissue in-growth. The openings may be pits formed in one side of the body and/or tongue of the reinforcing implant, or may be formed as through-holes. In one embodiment, the tongue includes an atraumatic barb or widened portion for anchoring the tongue in the peritoneum. Preferably at least one of the first and second arms includes one or more frangible regions facilitating resizing of the reinforcing implant by shortening the respective arm.

In accordance with a further aspect of the present invention, there is provided a vaginal splinting appliance for use in repair of the vaginal wall or uterus, the appliance having a body portion shaped to support a substantially normal vaginal apex. The vaginal splinting appliance includes attachment means for attaching the splinting appliance to the vaginal wall and means for receiving a vaginal elevator device inserted in the vaginal canal during surgery to aid in location of the vaginal apex. Preferably, the vaginal splinting appliance has a hollow region for receiving an end portion of the vaginal elevator device so as to couple the splinting appliance and the elevator device.

The vaginal splinting appliance may further include lateral extensions attachable to the left and right vaginal walls, wherein each lateral extension may provide one or more attachment means. The attachment means may include one or more of e.g. a suture eyelet, a hook and a barb. Alternatively/additionally, the lateral extensions may include break-off or trimmable portions separable from the appliance for re-sizing.

According to yet another aspect, the present invention provides a vaginal elevator comprising:

(a) a body portion configured to be coupled with a vaginal splinting appliance;

(b) a shaft attached to the body; and

(c) a handle portion on the shaft for gripping by a user.

Preferably, the handle portion and the shaft are oriented approximately 30 degrees to one another. In a preferred embodiment, part of the body portion of the vaginal elevator is adapted to fit within a hollow portion of a vaginal splinting device.

According to another aspect still, the present invention provides a kit for vaginal wall or uterus repair surgery, the kit including:

(a) a reinforcing implant;

(b) a vaginal splinting appliance; and

(c) instructions for performing a surgical method described in the foregoing.

The instructions may be provided in written form, and/or in pictographic form.

Alternatively/additionally, the instructions may be provided in the form of an audiovisual instruction set in which the method is demonstrated with a real example or pictographic example, and recorded in an electronic format such as mp3 or avi file and stored on DVD or other electronic storage media. The kit may also include a vaginal elevator device configured for releasable coupling with the vaginal splinting appliance.

According to another aspect, the present invention provides a method for repairing a vaginal wall damaged by pelvic organ prolapse, including the steps of:

(a) forming an access opening to provide abdominal access to the vaginal apex;

(b) introducing a reinforcing implant, having a body and a tongue, through the access opening and positioning the body of the reinforcing implant over a portion of the vaginal wall for repair; (c) attaching at least a portion of the body of the reinforcing implant to the vaginal wall;

(e) stabilizing the placement of the reinforcing implant such that it is capable of remaining positioned in situ for a duration sufficient to achieve tissue in-growth into the reinforcing implant.

According to another aspect still, the present invention provides a method for repairing a vaginal wall damaged by pelvic organ prolapse, including the steps of: (a) forming an access opening to provide abdominal access to the vaginal apex;

(b) introducing a reinforcing implant, having a body and a tongue, through the access opening and positioning the body of the reinforcing implant over a portion of the vaginal wall for repair;

(e) stabilizing the placement of the reinforcing implant by locating a vaginal splinting appliance in the vaginal canal. Preferably, the splinting appliance is removed when tissue in-growth has occurred, i.e. when tissue growth is sufficient to resist reinforcing implant pull-out. In embodiment, the splinting appliance is removed after the reinforcing implant has been stabilized in situ for 20 to 30 days, more preferably for 22 to 27 days and more preferably still, for 25 days.

In another aspect, the present invention provides a method for repairing a vaginal wall damaged by pelvic organ prolapse, including the steps of:

(a) forming an access opening to provide abdominal access to the vaginal apex;

(d) positioning the tongue of the reinforcing implant anterior to the sacrum; and (e) stabilizing the placement of the reinforcing implant such that it is capable of remaining positioned in situ for a duration sufficient to achieve tissue growth onto the reinforcing implant. Thus, the invention is intended to cover methods, implants and kits in which the reinforcing implant is adapted to permit tissue on-growth, as well as or as an alternative to tissue in-growth. Such implants may be substantially solid although perforations or e.g. pits (as previously described) may be provide to improve tissue growth onto the implant.

Brief Description of the Drawings

The invention will now be described with reference to the accompanying drawings in which some preferred embodiments are illustrated. In the drawings:

Figure 1 is a schematic representation showing the vaginal canal anteriorly in the vicinity of the sacrum, and showing a portion of the sacral peritoneum, with a vaginal splinting appliance prior to insertion into the vaginal canal.

Figure 2 is schematic representation similar to Figure 1 , with a transparent view through the vaginal wall to show a vaginal splinting appliance located therein, and vaginal elevator shaft device, and also showing the location for making first and second peritoneal openings in the peritoneum.

Figure 3 is a schematic representation similar to Figures 1 and 2, showing anterior and posterior arms of a reinforcing implant positioned over and attached to the anterior and posterior vaginal walls, with a tongue of the implant passed through a tunnel formed in the peritoneum.

Figure 4 is a schematic representation similar to Figures 1 to 3, with a transparent view thorough the vaginal wall to show the vaginal splinting appliance in situ, and also showing removal of a vaginal elevator.

Figures 5a and 5b are schematic representations showing front and side views respectively of a vaginal splinting appliance according to an embodiment of the invention.

Figures 6a and 6b are schematic representations showing front and side views respectively of a vaginal elevator device for use with an embodiment of the invention.

Figure 7a is a schematic representation showing the vaginal elevator device of Figures 6a and 6b just prior to insertion within the vaginal splinting appliance of Figures 5a and 5b. Figure 7b is a schematic representation of the vaginal splinting appliance in transparent view, showing the elevator device positioned therein.

Figures 8a, 8b and 8c are front, side and perspective views of a reinforcing implant according to an embodiment of the invention.

Detailed Description

Referring firstly to Figure 1 , components of the pelvic anatomy of a woman are shown in a schematic illustration. Vaginal canal 100 has apex 101 and opening 102 into which vaginal splinting appliance 500 is inserted. Prior to insertion, the vaginal splinting appliance is coupled with the body 601 of a vaginal elevator device 600 (see Figures 6a, 6b) of which only shaft 602 is visible in Figure 1 . A portion of the sacral peritoneum 200 is shown, overlaying part of the sacrum 201 in the region of the sacral curve.

Following induction with general anesthesia the woman is placed in a low lithotomy position. Preferably the inventive surgical method is performed via laparoscopy or other minimally invasive technique although it may also be performed via a laparotomy incision or by robotic or robotic-assisted surgery through the abdomen.

Standard techniques are used to introduce a 10 mm operating laparoscope at the umbilicus. Under laparoscopic vision, two ports are inserted through the anterior abdominal wall into the peritoneal cavity. For a right-handed surgeon this includes a 10 mm port on the patient's left and a 5 mm port on the patient's right. Preferably these ports are sited two fingerbreadths above and two fingerbreadths medial to the anterior superior iliac spine to avoid injury to the inferior epigastric artery and vein and damage to the lateral cutaneous nerve to the thigh. A further 5 mm port is introduced suprapubically in the midline under laparoscopic vision. The vaginal splinting appliance 500 is inserted into the vagina 100 as is illustrated in Figure 2 aided by a vaginal elevator device 600. Preferably, the vaginal splinting appliance 500 is sutured into position using lateral sutures 205, with one suture located in each of the lateral vaginal walls at a level above the hymen remnant (Figure 4). Preferably, sutures 205 are made through suture eyelets 502 of the vaginal splinting appliance.

Figures 5a and 5b illustrate front and side views respectively of a vaginal splinting appliance according an embodiment of the present invention. The vaginal splinting appliance may be manufactured from semi-rigid biocompatible, non-reactive material (e.g. medical grade silicon, PVC) and includes a body 501 and lateral extensions 503 with attachment means. In the embodiment illustrated, the attachment means are in the form of 3 pairs of suture eyelets 502a, 502b, 502c provided on lateral extensions 503. The lateral extensions may be trimmed for resizing. The vaginal splinting appliance illustrated in Figures 1 to 4 has been trimmed to remove the last suture eyelet, and sutures 205 (Figure 4) have been made through the second eyelet 502b on lateral extensions 503.

Various sizes and dimensions are contemplated for the vaginal splinting appliance 500. In one embodiment, the vaginal splinting appliance is approximately 8.5 cm in overall length and approximately 4 cm in overall width. In such embodiment, body 501 is approximately 5 cm long and approximately 4 cm wide with a maximum thickness of approximately 1 .25cm. A portion of the body 501 provides a hollow interior for receiving the body 601 of a vaginal elevator device 600. In one embodiment, lateral extensions 503 are approximately 3 cm long and 1 cm wide and have markings 504 which may be frangible such that the lateral extensions may be shortened by trimming or tearing off part of the extension. This enables the vaginal splinting appliance to be appropriately sized for an individual patient. In a preferred embodiment of the inventive method, the support provided by the vaginal splinting appliance 500 is maintained until tissue in-growth into the reinforcing implant fixes the implant in position. This helps to provide substantially tensionless placement of the reinforcing implant. Now turning to Figures 6a and 6b, front and side views of a vaginal elevator device 600 are shown. Vaginal elevator device includes a body 601 , a shaft 602 and a handle portion 603. The body portion is shaped to fit inside the vaginal splinting appliance 500 during surgery as shown in Figures 7a and 7b although other coupling arrangements may be contemplated. In the embodiment illustrated, the vaginal elevator device body 601 is approximately 3 cm wide, 3 cm long and with thickness that can be accommodated within the hollow in the vaginal splinting appliance (e.g. 1 cm). The shaft 602 is approximately 15 cm long and attaches at approximately 30 degrees to handle 603 which is approximately 12 cm in length. The vaginal elevator device 600 facilitates location of the vaginal apex and assists with placement of the implant onto the vaginal walls during the inventive surgical method.

With sutures placed through each of the right and left suture eyelets 502 and into the lateral vaginal walls, vaginal elevator device 600 is inserted. The vaginal elevator device 600 is inserted inside the vaginal splinting appliance 500 to assist the surgeon to identify the vaginal apex (vaginal vault). With the vagina elevated cranially using the vaginal elevator, the surgeon opens the peritoneum transversely at the vaginal apex. Dissection continues posteriorly into the rectovaginal septum so that the peritoneum is dissected off the upper half of the posterior vaginal wall. At around this point the rectovaginal septum is entered and the rectum is dissected off the middle and lower posterior vaginal wall. On occasion, dissection can be facilitated by using a rectal probe. This dissection is carried out in the midline and extended laterally on both sides to the insertion of the uterosacral ligaments. The bladder is then dissected off the upper anterior vaginal wall. This dissection continues to approximately the midpoint of the anterior vaginal wall. Dissection is continued laterally towards both bladder pillars but generally dissection of the bladder pillars is avoided. This is to reduce intra-operative bleeding and injury to the autonomic nerves to the bladder.

Figures 8a, 8b and 8c show front, side and perspective views of a reinforcing implant 800 according to an embodiment of the invention. The implant has a generally Y-shaped form with a tongue 801 and a body 802. In the embodiment shown, body 802 has first and second arms 802a, 802b which contact the anterior and posterior vaginal walls respectively. The arms join the tongue at implant apex 803. However, reinforcing implants having only one arm (e.g. posterior or anterior) joining the tongue at the implant apex, or having a significantly shortened arm (e.g. with one arm extending just beyond the apex), may also be contemplated. In a preferred embodiment, the implant includes one or more frangible regions 804 which facilitate re-sizing of the implant by shortening one or both of the arms prior to implantation. This may be useful e.g. when performing a repair of only the anterior vaginal wall, where the posterior arm may be removed by separating part of the implant along the relevant frangible line. The reinforcing implant tongue may also be trimmable e.g. for repair to the vaginal apex.

In one embodiment, the reinforcing implant may be manufactured from a type 1 light-weight mesh made from a monofilamentous material with pore sizes of around 75 microns, although other materials and pore sizes may be suitable.

In cases where the uterus is present the inventive surgical method may be performed concomitantly with a hysterectomy. Alternatively, if the uterus is conserved then the inventive approach may be used to perform a hysteropexy. When performing a hysteropexy the anterior arm of the implant is removed e.g. by tearing along anterior frangible line 804 or trimming with scissors prior to introduction of the implant into the pelvis. The posterior arm of the implant is attached to the supravaginal part of the posterior cervix with a monofilament non-absorbable or delayed absorbable suture (e.g. 2/0 Prolene or 2/0 PDS). Preferably the reinforcing implant is laser cut and has an anti-adhesion barrier on one side "C" of the reinforcing implant tongue 801 so that the pelvic peritoneum does not need to be closed over the implant. Various configurations and sizes are contemplated for the reinforcing implant. Preferably, the reinforcing implant tongue 801 is sufficiently long that it is able to rest along at least a portion of the curvature of the sacral hollow when in placed situ for tissue in-growth. Thus, the tongue may be e.g. 9 cm long or preferably about 13 cm long or as long as 20 or 25 cm. In one embodiment, the tongue is trimmable to accommodate the anatomy of the woman being treated. In one embodiment, the tongue is approximately 4.5 cm wide at its base, gradually tapering to approximately 1 cm width at the tip although this too may vary. The anterior arm 802a may have dimensions of approximately 5 cm length and 4.5 cm width. The posterior arm 802b may have dimensions of approximately 10 cm length and 4.5 cm width. It is to be understood, however, that the invention is not to be limited to the dimensions suggested herein. They are merely provided as a guide. In a preferred embodiment, the anterior arm has an anti-adhesion barrier "A" facing anteriorly when in situ and in the same orientation as the tongue. Meanwhile, the posterior arm may include an anti-adhesion barrier "B" facing posteriorly when in situ. Thus, both anterior and posterior arms, when enhanced with anti-adhesion properties, have the anti-adhesion barrier facing away from the vagina.

The reinforcing implant 800 is introduced into the abdominal cavity and correctly orientated in the pelvis so that the anti-adhesion barrier "C" on reinforcing implant tongue 801 is facing anterior and the apex 803 of the implant is directed cranially. The anterior and posterior leaves 802a, 802b of the implant are placed onto the upper anterior and posterior vaginal walls respectively as illustrated in Figures 3 and 4. The anterior and posterior arms of the implant are then tacked to the upper anterior and posterior vaginal walls respectively. Preferably this is achieved with a single absorbable suture 215 placed laparoscopically. The sutures may be e.g. 2/0 Vicryl or 2/0 Monocryl although other attachment means known in the art may be suitable. Alternatively, the anterior and/or posterior arms of the reinforcing implant may be tacked to the anterior and posterior vaginal walls by a bio-compatible tissue glue or adhesive material. Alternatively, the anterior and/or posterior arms of the reinforcing implant may be tacked to the anterior and posterior vaginal walls by sutures, staples or clips placed vaginally.

Once the implant arms have been tacked to the upper vagina, the sacral promontory is identified. The peritoneum over the sacral promontory is grasped and elevated. A first peritoneal opening 210 is formed as a transverse 1 .5 to 2 cm incision in the midline to allow entry into the presacral space and the anterior longitudinal ligament 250 is exposed by gentle blunt dissection of the presacral tissues over the sacral promontory. The reinforcing implant tongue 801 may be tucked into the first peritoneal opening. In one embodiment, the tip of the tongue 801 may include a barb, a projection or a widened portion which once inserted into the opening, minimizes the risk of the tongue retracting from the opening while the position of the reinforcing implant is stabilized during tissue in-growth.

In a preferred embodiment, a second peritoneal opening 220 is formed as a transverse 1 .5 to 2 cm incision, below first opening, in the midline in the hollow of the sacrum at about the level of the second sacral vertebra. A tunnel 230 is created beneath the peritoneum between the first and second peritoneal openings 210, 220 (e.g. sacral promontory and mid-sacral peritoneal incisions). This may be facilitated by grasping and elevating the lower part of the first peritoneal opening 210 (i.e. sacral promontory peritoneal incision) with a laparoscopic grasping forceps and introducing a tunneling device into this incision, making a tunnel down to, and then through, the second (i.e. mid-sacral) peritoneal opening 220. The tunneling device may be used to grasp the tip of the reinforcing implant tongue 801 which is then gently drawn back through the tunnel 230 until it comes into abutment with the anterior longitudinal ligament 250 ideally at, and just above, the level of the sacral promontory. Alternatively a second instrument such as forceps may be used to grasp and draw the reinforcing implant tongue 801 through the tunnel 230. In one embodiment, a single device is used to form the peritoneal openings and the tunnel.

Using this technique, it is possible to position the reinforcing implant 800 so that the reinforcing implant tongue 801 lies in the sacral hollow substantially without tension. The reinforcing implant tongue 801 need not be sutured, anchored, tacked nor stapled to the anterior longitudinal ligament 250. Rather, the vaginal splinting appliance 500 supports the position of the implant 800 during convalescence to allow for fixation of the reinforcing implant tongue 801 onto the sacral promontory and upper sacrum by a process of tissue in-growth into the interstices of the implant. Tissue in-growth may be stimulated by providing growth agents in the vicinity of the reinforcing implant, or onto those surfaces of the reinforcing implant where tissue ingrowth is encouraged. Preferably the period of convalescence is approximately 25 days although a period of a few more or a few less days may be required depending on the individual.

At the completion of surgery the pelvis is carefully inspected to ensure adequate haemostasis is present. The vaginal elevator device 600 is withdrawn from the vaginal splinting appliance 500 which remains in situ. The sigmoid colon is then gently placed over the reinforcing implant as it lies in the sacral hollow. Cystoscopy may be performed to exclude any urinary tract injury. Digital rectal examination should be performed to exclude any rectal injury. The pneumoperitoneum is released, the laparoscopic instruments are removed and the port site incisions closed. A urethral catheter may be placed.

The surgical methods, appliances and devices disclosed herein aim to simplify procedures for repairing vaginal wall, vaginal vault and/or uterus prolapse so that the surgery may be more readily performed by an increased number of surgeons. By obviating the need for sutures to attach the reinforcing implant to tissue in the sacral promontory, more surgeons will be able to perform this surgery, thereby benefiting larger numbers of women. Use of the vaginal splinting appliance along with the vaginal elevator device and reinforcing implant with an anti-adhesion barrier during the procedure make surgery quicker to perform than other forms of prolapse repair, and with the potential to reduce complications associated with current methods.

Importantly, the inventive methods enable the reinforcing implant to be placed without sutures or other anchoring means in the sacral peritoneum enabling tensionless positioning of the implant. This has the potential to reduce problems associated with tensioned mesh as can arise in traditional therapies. Tensionless implant placement should result in reduced scar tissue formation, reduced implant retraction, less postoperative stress urinary incontinence, less pain and less sexual dysfunction. It is believed that reinforcing implants positioned in accordance with the inventive method can achieve excellent functional outcomes when stabilized with a vaginal splinting appliance during initial tissue in-growth.

As a result of tissue in-growth into the implant, the maximal 'pull-out' force of the implant is typically reached 25 days after implantation. By supporting the position of the implant with the vaginal splinting appliance for around 25 days after surgery, fixation of the implant to the sacral promontory by sutures, anchors or staples is not required. Resorbable sutures or fixations for tacking the implant arms onto the vaginal walls are required for initial placement but significant numbers of laparoscopically performed sutures are not required, thereby avoiding intricate and time consuming movements that are required in LSC approaches. This potentially makes the inventive methods simpler, quicker and safer to perform when compared to current methods. While the present invention has been described with reference to a particular example, it is to be understood that various modifications may be made to the surgical method without departing from the ambit of the invention. For instance it is contemplated that the method may involve positioning the tongue of the reinforcing implant along alternative structures such as the uterosacral ligaments. Similarly, modifications, alterations and/or additions may be made to the reinforcing implant, the vaginal splinting appliance and/or the vaginal elevator device without departing from the ambit of the present invention as defined in the claims appended hereto. Where the terms "comprise", "comprises", "comprised" or "comprising" are used in this specification (including the claims) they are to be interpreted as specifying the presence of the stated features, integers, steps or components, but not precluding the presence of one or more other features, integers, steps or components, or groups thereof.

Claims

The claims defining the invention are as follows:

1 . A method for repairing a vaginal wall damaged by pelvic organ prolapse, including the steps of:

(a) forming an access opening to provide abdominal access to the vaginal apex;

2. A method according to claim 1 wherein the reinforcing implant is not in tension immediately following its positioning according to claim 1 .

3. A method according to claim 1 or claim 2 wherein stabilizing the placement of the reinforcing implant includes locating a vaginal splinting appliance in the vaginal canal for a duration sufficient to achieve tissue in-growth into the reinforcing implant.

4. A method according to any one of the preceding claims including the step of, prior to attaching the body of reinforcing implant to the vaginal wall, elevating the vaginal vault to facilitate location of the vaginal apex.

5. A method according to any one of the preceding claims including the steps of:

(a) forming an opening in the peritoneum anterior to the sacral promontory; and

(b) locating a portion of the tongue of the reinforcing implant within the opening.

6. A method according to claim 5 wherein the opening is formed by:

(a) creating a first peritoneal opening anterior to the sacral promontory; and

(b) forming a tunnel from the first peritoneal opening into the pre-sacral space; wherein the tunnel receives at least a portion of the tongue of the reinforcing implant in the region of the sacral hollow.

7. A method according to claim 6 wherein forming the opening further includes:

(a) creating a second peritoneal opening above or below the first peritoneal opening; and

(b) extending the tunnel to the second peritoneal opening, between the peritoneum and the sacrum.

8. A method according to claim 6 or claim 7, wherein each peritoneal opening is a transverse incision in the midline allowing entry into the pre-sacral space.

9. A method according to claim 8 wherein each transverse incision has a length of 1 to 3 cm.

10. A method according to claim 8 or claim 9 wherein each transverse incision has a length of 1 .5 to 2.5 cm.

1 1 . A method according to any one of claims 8 to 10 wherein each transverse incision has a length of 1 .5 to 2 cm.

12. A method according to any one of claims 7 to 1 1 , wherein the tongue of the reinforcing implant is drawn through the tunnel until at least a portion of the tongue of the reinforcing implant rests superior to the peritoneal openings and in abutment with the anterior longitudinal ligament.

13. A method according to any one of the preceding claims wherein the duration sufficient to achieve tissue in-growth is 20 to 30 days.

14. A method according to any one of the preceding claims wherein the duration sufficient to achieve tissue in-growth is 22 to 27 days.

15. A method according to any one of the preceding claims wherein the duration sufficient to achieve tissue in-growth is about 25 days.

16. A method according to any one of the preceding claims including the step of securing the vaginal splinting appliance in position for the duration sufficient to achieve tissue in-growth.

17. A method according to claim 16 wherein said securing step includes suturing the vaginal splinting appliance to the lateral vaginal walls.

18. A method according to any one of the preceding claims wherein the reinforcing implant is a synthetic bio-compatible implant having a braided, porous, laser-cut, woven and/or mesh-like construction with a plurality of openings facilitating tissue ingrowth.

19. A method according to any one of the preceding claims wherein the vaginal wall being repaired includes the posterior vaginal wall, and the method includes:

(a) positioning a posterior arm of the body of the reinforcing implant onto an upper portion of the posterior vaginal wall; and

(b) attaching the posterior arm to the vaginal wall.

20. A method according to any one of the preceding claims wherein the vaginal wall being repaired includes the anterior vaginal wall, and the method includes:

(a) positioning an anterior arm of the body of the reinforcing implant onto an upper portion of the anterior vaginal wall; and

(b) attaching the anterior arm to the vaginal wall.

21 . A method for repairing a uterus damaged by pelvic organ prolapse, including the steps of:

(a) forming an access opening to provide abdominal access to the uterus;

(d) positioning the tongue of the reinforcing implant anterior to the sacrum; and (e) stabilizing the placement of the reinforcing implant in situ for a duration sufficient to achieve tissue in-growth into the reinforcing implant.

22. A method according to claim 21 wherein there is substantially tensionless placement of the reinforcing implant prior to tissue in-growth.

23. A method according to claim 21 or claim 22 wherein stabilizing the placement of the reinforcing implant includes locating a vaginal splinting appliance in the vaginal canal.

24. A method according to any one of claims 21 to 23 including the steps of:

(a) forming an opening in the peritoneum anterior to the sacral promontory; and

25. A method according to claim 24 wherein the opening is formed by:

(a) creating a first peritoneal opening anterior to the sacral promontory; and

26. A method according to claim 25 wherein forming the opening further includes:

27. A method according to claim 25 or claim 26, wherein each peritoneal opening is a transverse incision in the midline allowing entry into the pre-sacral space.

28. A method according to any one of claims 25 to 27, wherein the tongue of the reinforcing implant is drawn through the tunnel until at least a portion of the tongue of the reinforcing implant rests superior to the peritoneal openings and in abutment with the anterior longitudinal ligament.

29. A method according to any one of claims 21 to 28 wherein the duration sufficient to achieve tissue in-growth is 20 to 30 days, preferably 22 to 27 days and more preferably about 25 days.

30. A method according to any one of claims 23 to 29 including the step of suturing the vaginal splinting appliance to the lateral vaginal walls for the duration sufficient to achieve tissue in-growth.

31 . A method according to any one of claims 21 to 30, wherein the method includes:

(a) positioning a posterior arm of the body of the reinforcing implant onto an upper portion of the posterior vaginal wall and in contact with a supra-vaginal portion of the posterior cervix; and

(b) attaching the posterior arm to the posterior cervix.

32. A method according to any one of claims 19, 20 or 31 wherein said attaching step is achieved using a single resorbable suture, staple, clip, tack, fastener, tissue glue or biocompatible adhesive material.

33. A method according to any one of the preceding claims including the step of separating at least a portion of the posterior and/or anterior vaginal wall from surrounding tissue to facilitate positioning at least a portion of the implant body on the vaginal wall.

34. A method according to any one of the preceding claims performed using Minimally Invasive Surgery (MIS) techniques.

35. A method according to any one of the preceding claims performed, at least in part using robotic surgical techniques.

36. A software program product embodying instructions for controlling a robotic surgical apparatus performing steps in the method of any one of the preceding claims.

37. A software program product embodying instructions for providing an interface between a user and a robotic surgery control system with which a user plans or executes a robotic surgery according to the method of any one of claims 1 to 35.

38. A reinforcing implant for use in vaginal wall repair, the reinforcing implant having a tongue and a body, the body having first and second arms for supporting the anterior and posterior vaginal walls respectively, the first and second arms joining the tongue at a reinforcing implant apex; wherein the tongue has a length sufficient to rest within at least a portion of the curvature of the sacral hollow when in situ in a female subject.

39. A reinforcing implant for use in repair of the uterus, the reinforcing implant having a tongue and a body, the body having first and second arms for supporting the anterior and posterior walls of one or both of the uterus and vagina, the first and second arms joining the tongue at a reinforcing implant apex; wherein the tongue has a length sufficient to rest within at least a portion of the curvature of the sacral hollow when in situ in a female subject.

40. A reinforcing implant according to claim 38 or claim 39, wherein the tongue has a length of 9 to 13 cm.

41 . A reinforcing implant according to any one of claims 38 to 40, wherein at least one of the first and second arms includes one or more frangible regions facilitating resizing of the reinforcing implant by shortening the respective arm.

42. A reinforcing implant according to any one of claims 38 to 41 , wherein at least a portion of a surface of the first and second arms facing away from the vaginal wall or uterus when implanted have anti-adhesion properties.

43. A reinforcing implant according to any one of claims 38 to 42, having a braided, porous, laser-cut, woven and/or mesh-like construction with a plurality of openings facilitating tissue in-growth.

44. A reinforcing implant according to any one of claims 38 to 43 wherein the tongue includes an atraumatic barb for anchoring the tongue in the peritoneum.

45. A vaginal splinting appliance for use in repair of the vaginal wall or uterus, the appliance including:

a body portion shaped to support a substantially normal vaginal apex;

attachment means for attaching the splinting appliance to the vaginal wall; and means for receiving a vaginal elevator device inserted in the vaginal canal during surgery to aid in location of the vaginal apex.

46. A vaginal splinting appliance according to claim 45, having a hollow portion for receiving an end portion of the vaginal elevator device.

47. A vaginal splinting appliance according to claim 45 or claim 46, including lateral extensions attachable to the left and right vaginal walls.

48. A vaginal splinting appliance according to claim 47 wherein each lateral extension has one or more attachment means selected from the group including: a suture eyelet, a hook and a barb.

49. A vaginal splinting appliance according to claim 47 or claim 48 wherein the lateral extensions include break-off portions separable from the appliance for resizing.

50. A vaginal elevator comprising:

(a) a body portion configured to be coupled with a vaginal splinting appliance;

(b) a shaft attached to the body; and

(c) a handle portion on the shaft for gripping by a user.

51 . A vaginal elevator according to claim 50, configured to be coupled with a vaginal splinting appliance according to any one of claims 45 to 49.

52. A vaginal elevator according to claim 50 or claim 51 , wherein the handle portion and the shaft are oriented approximately 30 degrees to one another.

53. A vaginal elevator according to any one of claims 50 to 52, wherein at least part of the body portion of the vaginal elevator is adapted to fit within a hollow portion of a vaginal splinting device.

54. A kit for vaginal wall or uterus repair surgery, the kit including:

(a) a reinforcing implant;

(b) a vaginal splinting appliance; and

(c) instructions for performing a surgical method according to any one of claims 1 to 35.

55. A kit according to claim 57 including a vaginal elevator device releasably couplable with the vaginal splinting appliance.

56. A method for repairing a vaginal wall damaged by pelvic organ prolapse, the method substantially as hereinbefore described with reference to any one of the embodiments illustrated in the accompanying drawings.

57. A method for repairing a vaginal wall damaged by pelvic organ prolapse, including the steps of:

(a) forming an access opening to provide abdominal access to the vaginal apex;

58. A method for repairing a vaginal wall damaged by pelvic organ prolapse, including the steps of:

(a) forming an access opening to provide abdominal access to the vaginal apex; (b) introducing a reinforcing implant, having a body and a tongue, through the access opening and positioning the body of the reinforcing implant over a portion of the vaginal wall for repair;

(e) stabilizing the placement of the reinforcing implant by locating a vaginal splinting appliance in the vaginal canal.

59. A method according to claim 58, wherein the splinting appliance is removed when tissue in-growth has occurred.

60. A method according to claim 58 or claim 59, wherein the splinting appliance is removed after the reinforcing implant has been stabilized in situ for 20 to 30 days, more preferably for 22 to 27 days and more preferably still, for 25 days.

61 . In another aspect, the present invention provides a method for repairing a vaginal wall damaged by pelvic organ prolapse, including the steps of:

(e) stabilizing the placement of the reinforcing implant such that it is capable of remaining positioned in situ for a duration sufficient to achieve tissue growth onto the reinforcing implant.

62. A reinforcing implant for use in vaginal wall repair surgery, the implant substantially as hereinbefore described with reference to any one of the embodiments illustrated in the accompanying drawings.

63. A vaginal splinting appliance substantially as hereinbefore described with reference to any one of the embodiments illustrated in the accompanying drawings.

64. A vaginal elevator substantially as hereinbefore described with reference to any one of the embodiments illustrated in the accompanying drawings.