Abstract:
A surgical support apparatus and method includes a central support member or portion and six or more straps or arms, with each of the straps comprising a connector configured to mate with a tip of a needle device. Each connector is adapted for attachment to target tissue within the pelvis of a patient such that attachment of the connectors to the patient tissue allows for selective placement of the central support member to provide internal pelvic support, e.g., treat vaginal prolapse. Further, a neo-ligament apparatus can be provided. The neo-ligament apparatus generally includes a first member, and a second member connected to and extending out from first member at a junction, at a predetermined angle.

Description:
RELATED APPLICATION 
       [0001]    This application claims priority to and the benefit of U.S. Provisional Application No. 61/159,719, filed Mar. 12, 2009, which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to urogenital surgery and, more specifically, to repairing genital prolapse in a patient. 
       BACKGROUND OF THE INVENTION 
       [0003]    Female genital prolapse has long plagued women. Vaginal prolapse develops when intra-abdominal pressure pushes the vagina outside the body. In a normal situation, the levator ani muscles close the pelvic floor. This results in little force being applied to the fasciae and ligaments that support the genital organs. Increases in abdominal pressure, failure of the muscles to keep the pelvic floor closed, and damage to the ligaments and fasciae all contribute to the development of prolapse. 
         [0004]    Many techniques have been tried to correct or ameliorate the prolapse and its symptoms, with varying degrees of success. Nonsurgical treatment of prolapse involves measures to improve the factors associated with prolapse, including treating chronic cough, obesity, and constipation. Other nonsurgical treatments may include pelvic muscles exercises or supplementation with estrogen. These therapies may alleviate symptoms and prevent worsening, but the actual hernia or weakness will remain. Vaginal pessaries are the primary type of nonsurgical treatment, but there can be complications due to vaginal wall ulceration. 
         [0005]    There is a desire to obtain a minimally invasive yet highly effective device and method that can be used to treat pelvic organ prolapse with minimal to no side effects. Such a device should increase organ support, reduce the complexity of the surgical procedure, be biocompatible, adjustable, and non-toxic. The treatment methods using the device should reduce pain, operative risks, infections and post operative hospital stays. Further, the method of treatment should also improve the quality of life for patients. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention broadly provides a method and apparatus for genital prolapse repair. In one embodiment, the method includes the steps of: establishing a plurality of pathways in tissue around a bladder of a patient, introducing a strap or arm into each of the pathways, and positioning beneath the bladder of the patient a support member having each of the straps connected thereto such that the bladder of the patient is supported by the support member. A bulge of the bladder into a vagina of the patient is reduced as a consequence of applying this method. 
         [0007]    In one embodiment, a surgical implant kit includes a support apparatus including a central support member and at least six straps or arms, each of the straps comprising a connector configured to mate with a tip of a needle. Each connector is adapted for attachment to or penetration through tissue within the pelvic region of a patient such that attachment of the connectors to the patient tissue allows for selective placement of the central support member to support the patient&#39;s bladder or other anatomical structures. The kit can further include a plurality of needle devices, adapted to engage and direct the connectors of the apparatus. 
         [0008]    In another embodiment, a surgical implant kit includes a support apparatus including a central support member and at least eight straps or arms, each of the straps comprising a connector configured to mate with a tip of a needle. Each connector is adapted for attachment to tissue within the pelvic region of a patient such that attachment of the connectors to the patient tissue allows for selective placement of the central support member to support the patient&#39;s bladder. 
         [0009]    In yet another embodiment, the connector and/or the straps of a support apparatus include indicia matching indicia on a corresponding needle device. 
         [0010]    In another embodiment, a neo-ligament apparatus is provided that generally includes a first strap or arm member, and a second strap or arm member connected to and extending out from the first member. The second member can extend out from the first member at an angle, such as approximately 45 degrees. Each of the members can include end connectors or anchors adapted for attachment to target tissue within the patient such that the neo-ligament apparatus can be employed to repair levator ballooning, vaginal prolapse, and/or rectal prolapse. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein: 
           [0012]      FIG. 1  is a fragmented front schematic view of a surgical support apparatus with connecting tabs and attachable connecting straps in accordance with embodiments of the present invention. 
           [0013]      FIG. 2  is a fragmented front schematic view of a surgical support apparatus with integral connecting straps in accordance with embodiments of the present invention. 
           [0014]      FIG. 3  is a fragmented front schematic view of a surgical support apparatus with attachable connecting straps in accordance with embodiments of the present invention. 
           [0015]      FIG. 4  is a fragmented front schematic view of a neo-ligament apparatus in accordance with embodiments of the present invention. 
           [0016]      FIG. 5  is a front schematic view of a neo-ligament apparatus with intermediate mesh support in accordance with embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0017]    Referring generally to  FIGS. 1-3 , a surgical support apparatus or implant  10  according to embodiments of the present invention is shown. The apparatus  10  can be configured and adapted to be surgically implanted in a female patient to repair anterior prolapse of the vagina. Further, the present invention may be used to correct central defects, midline defects, or both midline and central defects at once. 
         [0018]    Apparatus  10  can comprise four straps or arms  12   a - 12   d , four straps or arms  13   a - 13   d , and a support member or portion  40 . In such an embodiment, a total of eight straps  12 ,  13  are provided and can correspond with superior and inferior anatomical positioning and attachment. Straps  12   a ,  13   a  can be opposingly provided to extend at or proximate an end region of the support member  40 , with straps  12   b,c  and  13   b,c  positioned to extend at an intermediate or mid region of the support member  40 , and straps  12   d ,  13   d  extending from a tail or second end region of the support member  40 . Such strap mirroring generally provides bilateral attachment or support. 
         [0019]    In other embodiments, a total of six straps  12 ,  13  can be included with apparatus  10 . For instance, rather than providing two straps extending from each side of the support member mid region  40   b , a single strap could be included on each side at the mid region. Other embodiments are envisioned as well with varying combinations, numbers and configurations for providing the straps along the support member  40 . 
         [0020]    Each of straps  12   a - 13   d  and  13   a - 13   d  can include a connector or anchor  30  at its respective distal end. Further, each strap  12   a - 12   d  and  13   a - 13   d  can be covered by a respective sheath (not shown). The anchors  30  are adapted to attach to or penetrate through at least a portion of anatomical structure or tissue within the pelvic region of the patient. Certain embodiments of the anchors  30  can include one or more tines or barbs provided to facilitate tissue penetration and attachment. 
         [0021]    Straps  12   a - 12   d  and  13   a - 13   d  can be constructed of known compatible mesh material and can be connected to tabs  42   a - 42   d  and  43   a - 43   d  of support member  40 , respectively, by known means, as shown in  FIG. 1 . Alternatively, one or all of straps  12   a - 12   d  and  13   a - 13   d  can be integrally formed with support member  40 , as shown in  FIG. 2 . In yet another embodiment, the straps  12   a - 12   d  and  13   a - 13   d  can be connected to support member  40  by linking portions  36  of support member  40  with portions  38  of straps  12   a - 12   d ,  13   a - 13   d , as shown in  FIG. 3 . With such an embodiment, clips, rivets, rings, eyelets, grommets, or other mechanisms or devices known in the art can be used to attach portions  36 ,  38 . The positional attachment of straps or arms  12 ,  13  to tissue can vary depending on the particular support requirements and respective anatomy of the patient. 
         [0022]    In one embodiment, sheath is made of polyethylene. Other material may be used, such as polypropylene, nylon, polyester, or Teflon™. The sheath is configured for removal from the strap after the strap is in the correct position in the body. In general, the sheath can be employed to facilitate deployment of the apparatus, providing needed stiffness, tissue protection, or like benefits. 
         [0023]    Straps  12   a - 12   d  and  13   a - 13   d , and/or respective sheaths, may also include indicia provided thereon to signify the correct orientation for implantation into a patient. For instance, sheaths can include indicia to identify the respective straps  12  or  13  as superior or inferior straps during deployment, adjustment and general manipulation of the apparatus  10 . Words, symbols, and colors are all possible indicia that may be used, and these modifications are intended to be within the spirit and scope of the invention as claimed. Further, the indicia may be located on any or all of the straps, the connectors, and the sheaths. 
         [0024]    Suitable connectors or anchors, deployment tools, materials, devices and implant components envisioned for use with the present invention are disclosed in U.S. Pat. No. 7,351,197, International Patent Publication Nos. WO 2008/057261 and WO 2007/097994, and U.S. Patent Publication Nos. 2009/0192347, 2002/151762 and 2002/147382. Accordingly, the above-identified disclosures are hereby incorporated by reference in their entirety. 
         [0025]    In one embodiment, connectors  30  of each of the straps  12 ,  13  are configured to attach generally at eight respective tissue targets. As such, mirroring anatomical support connections (e.g., superior and inferior) are provided in pairing straps  12   a  and  13   a ,  12   b  and  13   b ,  12   c  and  13   c , and  12   d  and  13   d . For example, straps  12   a ,  13   a  can extend such that their connectors  30  are attachable at or proximate the obturator internus or levator muscles; straps  12   b ,  13   b  can be attachable at or proximate the “white line”; and straps  12   c - d ,  13   c - d  can be attachable at or proximate the uterosacral/cardinal ligament complex. 
         [0026]    Support member  40  can be sized and shaped to afford repair of a cystocele without directly lifting the patient&#39;s bladder and placing undue tension on the bladder or vaginal wall. Support member  40  can be constructed of various known materials utilized in repairing vaginal prolapse, e.g., compatible mesh or polymer materials. The shape of member  40  may be predetermined, or the member may be trimmed based on patient anatomy before implantation. For instance, support member  40  can include a tail portion  46  at end region  40   c  that can be trimmed according to the anatomy of the patient to prevent bunching. Similarly, the size and shape of support member  40  (e.g., regions  40   a - 40   c ), straps  12 ,  13 , and connectors  30  can vary widely depending on manufacturing and vaginal support objectives, as well as the anatomy of the particular patient. The final form of support member  40  can be manipulated during implantation based generally on its material and shape construct, and the attachment of straps  12 ,  13 . Further, various support attachment devices, sutures, material specifications, kit components, structures and other devices, methods and apparatus disclosed in the previously-incorporated references can be employed with the embodiments of the present invention. As shown in specific embodiments, the support member  40  can be generally wider at one end portion  40   a , with a degree of tapering at the mid region  40   b  or opposing end  40   c , to facilitate support, conformity, physical manipulation or overall performance of the implant  10 . For instance, as shown in the embodiments of  FIGS. 1-3 , the mid region  40   b  can be angled or tapered such that it is narrower at least along a portion of its length compared to the top end region  40   a . Further, the bottom or opposing end region  40   e  can extend from the mid region  40   b  to define the tail portion. The tail portion can be configured to have varying lengths depending on the particular application. The tail portion can be generally uniform for its width or it can taper or angle much like the previously-described mid region. 
         [0027]    Surgical support apparatus  10  can include a biological graft or synthetic body for support member  40 . To attach support member  40  to straps  12   a - 12   d  and  13   a - 13   d , clamps, rivets, sutures, rings, eyelets, grommets, or other known connecting devices or techniques, can be used to hold and secure the surfaces of the strap and member together. 
         [0028]    In various embodiments, support member  40  or straps  12 ,  13  can be constructed in whole, or in part, of a synthetic material, including polypropylene, cellulose, polyvinyl, silicone, polytetrafluoroethylene, polygalactin, Silastic, carbon-fiber, polyethylene, nylon, polyester (e.g., Dacron) polyanhydrides, polycaprolactone, polyglycolic acid, poly-L-lactic acid, poly-D-L-lactic acid and polyphosphate esters. Commercial examples of suitable synthetic materials include Marlex™ (polypropylene) available from Bard of Covington, R.I., Prolene™ (polypropylene); Prolene Soft Polypropylene Mesh or Gynemesh (nonabsorbable synthetic surgical mesh), both available from Ethicon, of New Jersey, and Mersilene (polyethylene terphthalate); Hernia Mesh also available from Ethicon, Gore-Tex™ (expanded polytetrafluoroethylene) available from W. L. Gore and Associates, Phoenix, Ariz.; the polymer supports available in the APOGEE™ PERIGEE™, or SPARC™ implant systems, available from American Medical Systems, Inc. of Minnetonka, Minn.; Dexon™ (polyglycolic acid) available from Davis and Geck of Danbury, Conn.; and Vicryl™ available from Ethicon. Other suitable synthetic materials known to those of ordinary skill in the art may be employed without deviating from the spirit and scope of the present invention. 
         [0029]    In certain embodiments, support member  40  or straps  12 ,  13  may be constructed in whole, or in part, of a non-synthetic material. Suitable non-synthetic materials include allografts, homografts, heterografts, autologous tissues, cadaveric fascia, autodermal grafts, dermal collagen grafts, autofascial heterografts, whole skin grafts, porcine dermal collagen, lyophilized aortic homografts, preserved dural homografts, bovine pericardium and fascia lata. Other suitable non-synthetic materials known to those of ordinary skill in the art may be employed without deviating from the spirit and scope of the present invention. 
         [0030]    The individual components or elements of the present invention may be packaged together in a kit assembly, including introduction or deployment devices or systems. Alternatively, the individual elements may be separately packaged or packaged in subassemblies depending on a variety of factors such as shelf life and sterilization requirements. They may be assembled at the manufacturing location or at the healthcare location. Any suitable sterilization procedure may be utilized to sterilize the contents of a kit. Suitable sterilization techniques include, but are not limited to, steam, ethylene oxide, electron beam, vapor (e.g., hydrogen peroxide or peracetic acid), gamma or plasma procedures. 
         [0031]    In preparation for surgery, the patient can be placed in a modified dorsal lithotomic position with hips flexed, legs elevated in stirrups and buttocks even with the edge of the surgical table. The patient&#39;s bladder is emptied. A catheter is not required during the procedure, but may aid in identifying the urethra during the procedure. A weighted vaginal retractor or other suitable vaginal retraction can be used, if desired. Various techniques, devices and procedures known to those of ordinary skill in the art, and those disclosed in previously-incorporated U.S. Pat. No. 7,351,197, and International Patent Publication Nos. WO 2008/057261 and WO 2007/097994, are available for positioning and attaching the support member  40  and its corresponding straps  12 ,  13  and connectors  30  within the patient. 
         [0032]    Referring generally to  FIGS. 4-5 , a neo-ligament apparatus or implant  100  in accordance with embodiments of the present invention is provided. The apparatus  100  generally includes a first strap or arm member  102 , and a second strap or arm member  104  connected to and extending out from first member  102 . The first and second members  102  and  104  can be integrally formed, or attached using known connection methods and techniques. In one embodiment, second member  104  extends out from first member  102  at an angle, such as approximately 45 degrees. Each of the members  102 ,  104  can include end connectors or anchors  106  adapted for attachment to target tissue within the patient. Each element or member of apparatus  100  can be constructed of materials, and configured with methods and techniques known to those of ordinary skill in the art, and as described herein or otherwise incorporated in the disclosures provided hereinabove. The neo-ligament apparatus  100  can be generally employed to repair levator ballooning, vaginal prolapse, rectal prolapse, and/or anal incontinence. As such, the apparatus  100  can replace or otherwise supplement anatomical structure within the pelvic region of the patient. 
         [0033]    In one embodiment, the apparatus  100  includes a juncture  108 , where an end portion of the second member  104  crosses or links with the first member  102 . This junction  108  can emulate the anatomical juncture of the arcus tendineus rectovaginalis (posterior white line) with the arcus tendineus fasciae pelvis (anterior white line). As such, first member  102  can emulate the anterior white line and second member  104  can emulate the posterior white line to provide pelvic support to repair ballooning of the levators through ligament reconstruction. The connectors  106  can be respectively configured for attachment to the tissue structure where the posterior and anterior white lines attach, such as the perineal body and the ischial spine. 
         [0034]    Further, first member  102  can include a plurality of optional, or selectively adjustable, connection points for second member  104  to create various junctures  108  along the length of first member  102 . This permits adjustment of the angle and positioning of the second member  104  relative to the first member  102  to accommodate the specific anatomy of a particular patient and the reconstructing support requirements of the patient. Further, various pins, rivets or other devices or connectors can be provided at the juncture  108  to facilitate rotation, movement and overall adjustability. 
         [0035]    In an alternative embodiment, apparatus  100  can further include an intermediate mesh portion  110 . The mesh portion  110  can provide a netting support extending from the first member  102  to the angled second member  104 , as shown in  FIG. 5 . The material construction, size, shape and positioning of the mesh portion  110  can vary widely depending on support requirements and the particular anatomy of the patient. In addition to those anatomical applications described, the apparatus  100  can be employed to provide neo-ligament or tissue support or repair for or along other anatomical structures within the pelvic region of the patient. 
         [0036]    All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications. 
         [0037]    Obviously, numerous modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced other than as specifically described herein.