Patent Publication Number: US-2010113870-A1

Title: Systems and methods for treating posterior pelvic organ prolapse

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority to U.S. Provisional Patent Application Ser. No. 61/095,226, filed Nov. 3, 2008, the disclosure of which is incorporated by reference in its entirety for all purposes. 
    
    
     DESCRIPTION OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to systems and methods for treating posterior pelvic organ prolapse, and more particularly, to transvaginal posterior pelvic organ prolapse treatment utilizing an integrated, light-weight support system. 
     2. Background of the Invention 
     Pelvic organ prolapse (POP) is one of the most common conditions requiring urogynecological surgery. POP occurs when the muscles of the pelvic floor are unable to support the pelvic organs (such as the patient&#39;s intestines). Rectocoele is a common form of posterior POP where the rectum loses support and pushes against the walls of the vagina. Enterocoele is a form of posterior POP where a portion of the small intestine prolapses. Rectoenterocoele refers to the condition where both the rectum and small intestine prolapse into the vagina. Rectocoele, enterocoele, and rectoenterocoele commonly occur when the muscles of the pelvic floor are damaged or weakened during childbirth. 
     According to an analysis of U.S. procedure codes for prolapse surgery, it is estimated that more than a half-million procedures are performed annually accounting for more than one-billion health care dollars. Epidemiological studies demonstrate that only a fraction of women with POP seek medical attention and that the incidence (i.e., the number of new cases during a specified time) and prevalence (i.e., the number of affected persons during a specified time divided by the number of persons in the population at that time) rates based on surgical intervention significantly underestimate the magnitude of this problem. 
     It is estimated that women have an 11% lifetime risk of undergoing a single operation for POP and Urinary Incontinence by age 80 years. Studies have shown that 50% of parous women lose pelvic floor support resulting in POP. Although difficult to determine the number of women affected by POP, it is estimated that the general population of women will increase by 22% over the next 30 years and the demand for care for pelvic floor disorders increase by 45%. 
     Surgery for pelvic floor disorders such as POP and Stress Urinary Incontinence (SUI) is aimed at restoring or improving the function of the pelvic organs. The approach to these complex problems has varied over time and with the advancements in anatomical knowledge, technology and the development of biological and synthetic materials. One conventional method for repairing a rectocoele involves a combined transvaginal and transobturator approach. In this method, two incisions are made in the patient&#39;s buttocks, outside the patient&#39;s vagina. Helical needles are inserted through the incisions, through the obturator foramein in the pelvis, and finally through the vaginal wall at the sacrospinous ligament. The arms of a mesh cape placed within the vagina are attached to the ends of the needles, and the needles are withdrawn, bringing the arms of the cape outside the patient&#39;s body to be tightened. This method is extremely time consuming and difficult. It is difficult, particularly for inexperienced surgeons, to ensure the needles pierce the pelvic sidewalls in the correct location without causing injury to the patient. The patient is also at risk from infection, bleeding, nerve damage, and from the effects of being under anesthesia for long periods of time during the procedure. 
     As such, conventional systems and methods for addressing POP are still complicated, invasive and have a significant potential for harm to the patient, including death. The present invention addresses these and other issues. 
     SUMMARY OF THE INVENTION 
     Methods and systems according to the present invention can be used in treating all forms of posterior wall defects, including rectocoele, enterocoele, and rectoenterocoele. The treatment of posterior pelvic organ prolapse in accordance with the present invention is significantly quicker than other conventional approaches. For example, a surgeon employing systems and methods of the present invention can repair a rectocoele in about fifteen minutes, where other methods can take in excess of an hour. Additionally, the present invention provides a completely transvaginal solution to treating posterior pelvic organ prolapse, is easier for less experienced surgeons to perform, and poses far less risk of injury or death to the patient. 
     A system for treating posterior pelvic organ prolapse according to one aspect of the present invention comprises a cape for supporting a posterior organ (such as a bowel and/or rectum) that has prolapsed into a vagina, a plurality of support arms coupled to the cape, and a plurality of fasteners for attaching the support arms to a portion of the pelvic sidewall. Each one of the plurality of fasteners is coupled to a respective one of the plurality of support arms. The system may further include a tension adjustment system. Among other things, the present invention provides an integrated, pre-fabricated solution for treating posterior pelvic organ prolapse. All components of the system can thus be quickly deployed, without the need to build the repair system piecemeal. Among other things, this results in quicker surgeries, less risk to the patient from anesthesia, and less risk of failure of the repair due to the improper assembly of the repair system. The multiple points of fixation also help recreate and restore the normal structural support of the pelvic sidewall. 
     A method for treating posterior pelvic organ prolapse according to another aspect of the present invention comprises attaching a pair of support arms to a portion of the pelvic sidewall, the pair of support arms coupled to a cape. The method further includes positioning the cape over a posterior organ (such as a rectum and/or bowel) that has prolapsed into the vagina. The method may also include adjusting the support arms using a tension adjustment system. This method can be performed more quickly (and is less difficult) than conventional solutions for posterior pelvic organ prolapse, allowing less experienced surgeons to perform the repair without the risk of substantial harm to the patient present in conventional methods. 
     Both the foregoing summary and the following detailed description are exemplary and explanatory only and are not restrictive of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A more complete understanding of the present invention may be derived by referring to the detailed description and claims when considered in connection with the following illustrative figures. 
         FIG. 1  depicts an exemplary system for the treatment of posterior pelvic organ prolapse according to various aspects of the present invention. 
         FIGS. 2A-2E  depict exemplary fasteners for attaching a support arm to the pelvic sidewall according to various aspects of the present invention. 
         FIG. 3  is a flow diagram depicting an exemplary method for rectocoele repair according to various aspects of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     An exemplary system  100  according to various aspects of the present invention is depicted in  FIGS. 1 . This system  100  may be used in conjunction with the method described in  FIG. 3 , as well as with any subset or combination of the elements thereof. The system  100  shown in  FIG. 1  may also be used in conjunction with any other suitable embodiments of systems and methods, including systems and methods for treating other forms of pelvic organ prolapse (POP). 
     System  100   
     The exemplary system  100  depicted in  FIG. 1  includes a cape  110 , a pair of support arms  120 , fasteners  140  coupled to the support arms  120  and a tension adjustment system  150 . The system  100  is shown covering a rectocoele as viewed from the top of the patient&#39;s pelvis. The support arms  120  attach to the pelvic sidewalls to keep the system  100  in place in order to retain the rectocoele. As used herein, the term “pelvic sidewall” generally refers to any tissue, muscle, ligament, or other structure surrounding and/or defining the vaginal cavity, including the Obturator Internus muscle, Levator Ani muscle, ischial spine, Sacrospinous ligament and/or vaginal mucosa. 
     Cape  110   
     The cape  110  is configured to support a posterior organ (such as a rectum or bowel) that has prolapsed into the vagina. The cape  110  may be any size, shape, and configuration to allow the cape  110  to cover and support the prolapsed organ. The cape  110  may be formed from any suitable material, such as a biological material (including porcine dermus) and/or synthetic material (including polypropylene). In the present exemplary embodiment, the cape  110  is formed from a lightweight synthetic mesh. The mesh cape  110  allows the tissue of the pelvic sidewall to grow across the cape, strengthening the area of the prolapse while the cape retains the posterior organ. The cape  110  can be partially flexible and/or partially elastic to aid in the placement of the system and/or retention of a rectocoele and/or enterocoele. The size and shape of the cape  110  in  FIG. 1  can be altered (e.g., by a surgeon using scissors) prior to installation to conform to a rectocoele and/or enterocoele having a particular size and/or shape. Additionally, the cape  110  may include materials of relatively less rigidity and/or flexibility than other portions of the cape  110  to, for example, provide strength and stability to the system  100 . 
     Support Arms  120   
     The support arms  120  attach to portions of the pelvic sidewalls to help secure the cape  110  in place in order to retain the prolapsed posterior organ. The support arms  120  can be any desired dimension (including size, shape, length, width, and thickness). The dimensions between different support arms  120 , as well as the dimensions throughout an individual support arm  120 , may vary. In the present exemplary embodiment, a pair of support arms  120  are coupled to opposing sides of the cape. Using the fasteners  140  described below, the support arms  120  are configured for attachment to the Sacrospinous ligament of the pelvic sidewall. 
     The support arms  120  can be formed from any desired material. The support arms  120  can be made from the same, or different material(s) than the cape  110 . For example, the support arms  120  can be formed from synthetic material (such as polypropylene), biological material (such as porcine dermus), or a combination of synthetic and biological materials. The support arms  120  and cape  110  can be made from a unitary piece of material, such as a piece of synthetic and/or biological mesh. Among other things, forming the cape  110  and the support arms  120  from a unitary piece of material can increase the strength and/or flexibility of the system  100 . Additionally, the unitary construction of the system  100  allows the system  100  to be quickly deployed, without the need to assemble the system  100  piecemeal. Among other things, this results in quicker surgeries, less risk to the patient from anesthesia, and less risk of failure of the repair due to the improper assembly of the repair system  100 . 
     Fasteners  140   
     Fasteners  140  coupled to the distal ends of the support arms  120  are configured to attach the support arms  120  to the pelvic sidewall. Any suitable fastener may be used in conjunction with the present invention to attach the support arms  120  to any suitable portion of the pelvic sidewall.  FIG. 2A  depicts one exemplary embodiment of a fastener according to various aspects of the present invention. In  FIG. 2A , a fastener  200  comprises a body portion  202 , a proximal end  204  that is coupled to a support arm (not shown), a distal end  206 , and one or more barbs  208  coupled to the exterior of the body portion  202  for attaching the fastener to the pelvic sidewall. The body portion  202  is cylindrical, approximately 1 to 2 centimeters long, and approximately 0.25 centimeters in diameter in the exemplary embodiment depicted in  FIG. 2A , though the body portion of a fastener utilized in conjunction with the present invention may be any suitable size and shape. Likewise, the exemplary fasteners depicted in  FIGS. 2B-2D  and discussed below may also be any suitable size and shape. 
     The body portion  202  of the exemplary fastener  200  is hollow to allow a surgeon to pass a needle through the body portion  202  and perforate the pelvic sidewall in order to insert the fastener  200  in the perforation. The needle can then be withdrawn. The barbs  208  help keep the fastener  200  attached to the pelvic sidewall (such as into the Sacrospinous ligaments) once inserted in the perforation. To assist in inserting the fastener  200  in the perforation, the distal end  206  may be tapered or comprise any other shape or configuration to help guide the fastener  200  into the perforation. In the exemplary fastener  200  depicted in  FIG. 2A , the barbs extend from the exterior of the body portion  202  towards the proximal end  204  in order to resist being pulled free from the pelvic sidewall. 
       FIG. 2B  depicts an alternate exemplary fastener  210  according to various aspects of the present invention. In this exemplary embodiment, fastener  210  includes a body portion  212  having a proximal end  214  that is coupled to a support arm (not shown), a pointed distal end  216 , and one or more barbs  218 . This exemplary embodiment allows a surgeon to perforate the pelvic sidewall with the pointed distal end  216 , which obviates the need to perforate the pelvic sidewall with a separate needle. The body portion may be at least partially hollow (e.g., to allow a tool to be inserted within the body portion  212  to help press the fastener  210  into place) or solid (e.g., to provide added rigidity and/or strength). 
       FIG. 2C  depicts yet another exemplary fastener  220  according to various aspects of the present invention. In this exemplary embodiment, fastener  220  includes a body portion  222  having a proximal end  224  that is coupled to a support arm (not shown), a pointed distal end  226 , and one or more barbs  228 . In this exemplary embodiment, the body portion comprises a non-rectilinear section  229 . In this embodiment, the non-rectilinear section  229  is curved to create ninety degree angle to allow the proximal end  224  to run parallel to the pelvic sidewall. Among other things, the non-rectilinear section  229  aids a surgeon in keeping the support arm coupled to the fastener  220  closer to the surface of the vaginal wall. Instead of protruding out from the surface of the pelvic sidewall, the support arm (connected to the proximal end  224 ) can be run from the site of the fastener  220  to the cape with less of a gap between the pelvic sidewall and the support arm. 
     The exemplary fastener  230  depicted in  FIG. 2D  includes a hollow body portion  232  having a proximal end  234  that is coupled to a support arm (not shown), a distal end  236 , and one or more barbs  238 . Alternately, this embodiment could implement a pointed distal end (such as ends  216  and  226  shown in  FIGS. 2B and 2C , respectively). The exemplary embodiment depicted in  FIG. 2D  also includes a structure  239  to prevent the fastener from penetrating the pelvic sidewall beyond a predetermined depth. The structure may be any size, shape and configuration, and may be located anywhere on the fastener to prevent it from penetrating beyond a predetermined depth in the pelvic sidewall. In  FIG. 2D , the structure comprises a lip radiating from the external surface of the body portion  234 . In this embodiment, the lip  239  extends beyond the total outside diameter of the barbs  238  to allow it to contact the pelvic sidewall, preventing the fastener  230  from penetrating beyond the depth of the lip  239 . 
     The exemplary fastener  240  depicted in  FIG. 2E  includes a hollow body portion  242  having a proximal end  244  that is coupled to a support arm (not shown), a distal end  246 , and one or more barbs  248 . In this exemplary embodiment, the barbs  248  extend from the external surface of the body portion towards the distal end  296  (i.e., opposite to the barbs  208  shown in  FIG. 2A ). Among other things, this allows a surgeon to more easily remove the fastener  240  (e.g., to correct its placement), while still allowing the barbs  248  to engage the muscle or tissue of the pelvic sidewall to keep the fastener  240  in place once the fastener  240  is correctly located. 
     Any of the features of the exemplary fasteners depicted in  FIGS. 2A-2E  and described above may be combined or substituted in accordance with the present invention. While the body portions of the fasteners are depicted as cylindrical, alternate embodiments may include body portions having any size, shape, and configuration. For example, the body portions may be at least partially flexible and/or non-rectilinear. Likewise, the barbs utilized on the exemplary fasteners may be any size, shape, and configuration to allow the fastener to attach to the pelvic sidewall. Fasteners used in conjunction with the present invention can be permanently, or releasably, coupled to the support arms  120 . Any of the barbs used in conjunction with the fasteners depicted in  FIGS. 2A-2E  can be configured to dynamically collapse and extend from the exterior of the body portion to allow the fastener to be inserted and removed from the pelvic sidewall. 
     Tension Adjustment System  150   
     The tension adjustment system  150  allows a surgeon to adjust the tension of the support arms  120  and/or the cape  110  to ensure the cape  110  properly retains the rectocoele. The tension of the support arms  120  and/or cape  110  may be adjusted in any manner using any desired system or device. In the present exemplary embodiment, each support arm  120  includes a tension adjustment system  150  that comprises a grommet coupled to the support arm using a tensioning suture. The tensioning suture loops through an aperture in the support arm. In the case that the support arms are formed from mesh, the aperture through which the tensioning suture loops may be one of the openings formed by the mesh itself. The tensioning grommet includes two holes through which the two respective ends of the tensioning suture pass. A surgeon can adjust the tensioning grommet along the tensioning suture with one hand while holding the two ends of the tensioning suture with the other hand. Once the desired tension is achieved in the support arm and/or cape, the ends of the tensioning suture can be tied, holding the grommet in place and maintaining the level of tension. In this manner, a surgeon is able to increase or decrease the amount of tension in the support arms  120  or cape  110  in order to ensure a rectum or intestine that has prolapsed into the vagina is properly supported. 
     The grommets depicted in  FIG. 1  are substantially cylindrical, though grommets in alternate embodiments of the present invention can be any size, shape, and configuration. The grommets can be formed from any material, such as a biocompatible synthetic. Likewise, the tensioning suture can be formed from any material and can be any suitable length and diameter to help maintain the tension of the support arm. 
     Any other tension adjustment system may be used in conjunction with the present invention to adjust the tension of the support arms  120  and/or the cape  110 . In other exemplary embodiments, the tensioning system  150  for each support arm can be formed from any other suitable fastener connected to the support arm, such as a button, clasp, buckle, hook and loop fastener, clip, ring, clamp, snap, and/or staple. In one such embodiment, a button comprising a first portion that is attached to a support arm has a pair of openings through which a tensioning suture is looped. A second portion of the button is releasably attached to the first portion, the second portion also including a pair openings through which the two ends of the tensioning suture can be passed. A surgeon can adjust the tension in the support arm, fasten the first and second portions of the button together, then tie the tensioning suture to maintain the level of tension in the support arm. 
     Operation 
     An exemplary method according to various aspects of the present invention is depicted in  FIG. 3 . This method may be practiced in conjunction with the system depicted in  FIG. 1 , as well as the fasteners depicted in  FIGS. 2A-2E . In this method, the patient is placed in the lithotomy position ( 302 ) and a transverse incision is made along the vaginal epithelium ( 305 ). The vagina is separated from the prolapsed rectum and/or intestine ( 310 ) and the support arms coupled to the cape of the rectocoele repair system are attached to the Sacrospinous ligaments on opposing sides of the rectocoele and/or enterocoele ( 315 ). The cape is laid over the rectocoele and/or enterocoele and secured with interrupted sutures ( 320 ). The support arms of the system are adjusted and tightened with the tension adjustment system ( 325 ) (e.g., by using a tension adjustment grommet secured with a tension suture). The vaginal incision is closed ( 330 ) and the procedure terminated. 
     The particular implementations shown and described above are illustrative of the invention and its best mode and are not intended to otherwise limit the scope of the present invention in any way. Indeed, for the sake of brevity, conventional data storage, data transmission, and other functional aspects of the systems may not be described in detail. Methods illustrated in the various figures may include more, fewer, or other steps. Additionally, steps may be performed in any suitable order without departing from the scope of the invention. Furthermore, the connecting lines shown in the various figures are intended to represent exemplary functional relationships and/or physical couplings between the various elements. Many alternative or additional functional relationships or physical connections may be present in a practical system. 
     Changes and modifications may be made to the disclosed embodiments without departing from the scope of the present invention. These and other changes or modifications are intended to be included within the scope of the present invention, as expressed in the following claims.