Patent Publication Number: US-2011077456-A1

Title: Prolapse repair device and methods of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 61/247,257, filed Sep. 30, 2009, the content of which is incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     An anterior vaginal wall prolapse occurs when the vaginal wall fails to hold the bladder in place. Anterior vaginal wall prolapse may present as one of two defects. Paravaginal defect is caused by weakness in the lateral supports (pubourethral ligaments and attachment of the bladder to the endopelvic fascia), and central defect is caused by weakness in the central supports. A posterior vaginal wall prolapse occurs when the rectum descends into the vagina. The severity of the prolapse is typically rated from stage I to stage IV, with stage IV being the most severe. Other prolapse conditions are known, including the presence of small intestine in a hernia sac between the rectum and vagina, called an enterocele. 
     Several factors have been implicated as contributing genital prolapse in women. Genetic differences result in individual women having different inherent strength of the relevant connective tissue. Environmental and behavioral differences also play a role, however. For example, loss of connective tissue strength might be associated with damage at childbirth, deterioration with age, poor collagen repair mechanisms, and poor nutrition. Loss of muscle strength might be associated with neuromuscular damage during childbirth, neural damage from chronic straining, and metabolic diseases that affect muscle function. Other factors involved in prolapse include increased loads on the supportive system, as seen in prolonged lifting or chronic coughing from chronic pulmonary disease, or some disturbance in the balance of the structural support of the genital organs. Obesity, constipation, and a history of hysterectomy have also been implicated as possible factors. 
     There are generally two different types of tissue that make up the supportive structure of the vagina and uterus. First, there are fibrous connective tissues that attach these organs to the pelvic walls (cardinal and uterosacral ligaments; pubocervical and rectovaginal fascia). Second, the levator ani muscles close the pelvic floor so the organs can rest on the muscular shelf thereby provided. It is when damage to the muscles opens the pelvic floor or during the trauma of childbirth that the fascia and ligaments are strained. Breaks in the fascia allow the wall of the vagina or cervix to prolapse downward. 
     Treatment for vaginal prolapse varies based on the symptoms of the prolapse as well as the health and age of the patient. If symptoms are more severe, treatment is commonly by either surgery or pessary. Surgical options might include hysterectomy, however newer sling methods have reduced the incidence of hysterectomy associated with prolapse repairs. Such procedures may include abdominal or vaginal access routes. Sacralcolpopexy or sacrospinous fixation may be used. 
     Unfortunately, many women who undergo surgery to repair prolapsed organs experience re-prolapse, pain, or infection. The high failure rate for prolapse repair has motivated the development of a number of implants to augment the known prolapse repair methods. Studies indicate that the implants have reduced the recurrence of prolapse as well as the morbidity associated with prolapse repair. Among the more successful implants, synthetic mesh systems for prolapse repair such as PINNACLE (Boston Scientific, Natick, Mass.) and ELEVATE (American Medical Systems, Minnetonka, Minn.) provide a means to support prolapsed organs by securing a mesh sling to various anatomical points within the pelvis. The mesh repair systems have proven especially beneficial for women who have weak tissues that otherwise would not support conventional prolapse repair. While mesh systems provide many benefits, long term results suggest an unacceptable rate of erosion of tissue, which can cause additional complications and require subsequent surgical procedures and hospitalization. Erosion rates between 10-20% have been reported (Watson,  J. Am. Coll. Surg ., vol. 183, p. 257 (1996)). In a recent study containing 43 cases the Pinnacle Pelvic Floor Repair Kit (Boston Scientific, Natick, Mass.) was used to correct anterior and apical pelvic floor defects. The study found a mesh erosion rate of about 27.9% and a surgical re-operation rate of about 14%. (Female Pelvic Medicine &amp; Reconstructive Surgery: March/April 2010—Volume 16—Issue 2—S19). 
     To avoid erosion of tissue by the mesh, medical device manufacturers have introduced dermis-based systems comprising human (allograft) or animal (xenograft) dermis, such as REPLIFORM (cadaver dermis) and XENFORM (bovine dermis), both from Boston Scientific. These dermis based-systems are typically affixed to one or more ligaments to provide support to the pelvic organs. While the dermis-based systems have lower rates of erosion, the dermis systems are not as simple to secure as the mesh-based systems, often requiring a larger dissection plane. Additionally, the dermis-based systems do not offer consistent support for ingrown tissues as the dermis material, like human tissue, stretches and tears. 
     Other hybrid systems have been developed to allow the incorporation of materials other than mesh. Several examples are shown in U.S. Published Patent Application No. 2008/0081945, published Apr. 3, 2008, and incorporated by reference herein. These systems offer easier placement than dermis, and because the sling may be made from non-mesh material, erosion complications may be minimized. For example, FIG. 1 of U.S. Published Patent Application No. 2008/0081945 shows a sling assembly with a trapezoidal sling and four support arms to aid securing the sling. 
     SUMMARY 
     The invention provides, among other things, an implantable prolapse repair device comprising a central graft material suitable for placement inside a human and first, second, and third mesh strips, suitable for placement inside a human body. The central graft material has at least two slits, a first connection point and a second connection point. The first mesh strip has a first free end, including a first needle attached thereto, and a second free end, including a second needle attached thereto. The first mesh strip is operatively coupled to the central graft material by weaving the first mesh strip through the at least two slits to form a supportive weave. The second mesh strip has a free end, including a needle attached thereto, and a connector end. The connector end of the second mesh strip is coupled to the first connection point of the central graft material. The third mesh strip has a free end, including a needle attached thereto, and a connector end. The connector end of the third mesh strip is coupled to the second connection point of the central graft material. The central graft material may comprise dermis or decellularized animal tissue. Each of the mesh strips may comprise at least one of polypropylene, polyethylene, polylactic acid (PLA), polyglycolic acid (PGA), poly-L-lactic acid (PLLA), polypeptides, and combinations thereof. 
     The invention additionally provides, among other things, a method for the repair of a prolapsed organ within a pelvis of a female using an implantable prolapse repair device of the invention. The method comprises dissecting anatomical structures beyond a vaginal wall through an incision in the vaginal wall to create a dissection plane, wherein the dissection plane has a first end and a second end of the anatomical structures, inserting an implantable prolapse repair device of the invention through the incision in the vaginal wall, coupling a cephalad end of the central graft material to a cervix or a vaginal cuff, coupling the first free end of the first mesh strip to a first sacrospinous ligament, coupling the second free end of the first mesh strip to a second sacrospinous ligament, coupling the free end of the second mesh strip to a first arcus tendineous, coupling the free end of the third mesh strip to a second arcus tendineous and suturing the central graft material to the second end of the anatomical structures defined by the dissection plane. In many embodiments, the supportive weave is spaced apart from the vaginal wall by the central graft material. The method may additionally comprise performing a site-specific repair. 
     The invention additionally provides, among other things, a prolapse repair kit comprising a central graft material suitable for placement inside a human and first, second, and third mesh strips, suitable for placement inside a human body. The central graft material has two slits and first and second connection points. The first mesh strip has a first free end, including a first needle attached thereto, and a second free end, including a second needle attached thereto. The second mesh strip has a free end, including a needle attached thereto, and a connector end. The third mesh strip has a free end, including a needle attached thereto, and a connector end. The two slits in the central graft material allow passage of the first mesh strip through the central graft material to form a supportive weave such that the first and second free ends extend outwardly from the central graft material. The connector end of the second mesh strip is coupleable to the first connection point of the central graft material, and the connector end of the third mesh strip is coupleable to the second connection point of the central graft material. The central graft material may comprise human dermis or decellularized animal tissue. Each of the mesh strips may comprise at least one of polypropylene, polyethylene, polylactic acid (PLA), polyglycolic acid (PGA), poly-L-lactic acid (PLLA), polypeptides, and combinations thereof. 
     The invention additionally provides, among other things, a method of making a prolapse repair device, comprising passing a first mesh strip through a central graft material having two slits, thereby forming a supportive weave, the first mesh strip having a first free end, including a first needle attached thereto, and a second free end, including a second needle attached thereto, the first and second free ends extending outwardly from the central graft material, coupling a connector end of a second mesh strip to a first connection point of the central graft material such that the free end of the second mesh strip extends outwardly from the central graft material, and coupling a connector end of a third mesh strip to a second connection point of the central graft material such that the free end of the second mesh strip extends outwardly from the central graft material. 
     Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a prolapse repair device in accordance with at least one embodiment of the present invention. 
         FIG. 2  shows an enlarged view of the prolapse repair device illustrated in  FIG. 1 . 
         FIG. 3  illustrates a kit used to assemble the prolapse repair kit shown in  FIG. 2  in accordance with at least one embodiment of the present invention. 
         FIG. 4A  illustrates placement of a first mesh strip of the prolapse repair device in a sacrospinous ligament. 
         FIG. 4B  illustrates placement of a second mesh strip of the prolapse repair device in the arcus tendineous. 
     
    
    
     Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. The figures referred to herein are not necessarily to scale; emphasis instead is generally placed upon illustrating the principles of the illustrated embodiments. 
     DETAILED DESCRIPTION 
     The invention discloses an improved prolapse repair devices that offers superior results when used to repair prolapsed organs. In one embodiment, shown in  FIG. 1 , an implantable prolapse repair device  100  comprises a central graft material  110 , a first mesh strip  120 , a second mesh strip  130 , and a third mesh strip  140 . The central graft material  110 , first mesh strip  120 , second mesh strip  130 , and third mesh strip  140  are all suitable for placement inside a human body. The central graft material  110  has at least two slits  150 , as well as a first connection point  160  and a second connection point  170 . (First connection point  160  and second connection point  170  need not be on a particular side of central graft material  110 , and are named “first” and “second” for convenience). In a further embodiment, the central graft material  110  may include more than two slits  150 . By example, the graft material  110  can include 3, 4, 5, 6 or more slits. The first mesh strip  120  is operatively coupled to the central graft material  110  by weaving the first mesh strip  120  through the at least two slits  150  to form a supportive weave  180 . (Supportive weave  180  need not be made from a woven material, however.) An anchor suture  190  can be used to couple the first mesh strip  120  and the central graft material  110  to restrict motion there between. Alternatively, the graft material is presented with out connection points  160 ,  170 , and the device utilizes one or more mesh strips. 
     The central graft material  110  can be constructed of any materials acceptable for placement within humans that have suitable mechanical properties. In some embodiments, the central graft material  110  can comprise dermis or decellularized animal tissue. The decellularized animal tissue can comprise, but need not be limited to, bovine tissue, porcine tissue, ovine tissue, or equine tissue. The central graft material  110  may be an omnidirectional material, a material that has equivalent tensile strength from any direction, such as pericardium or dermis. Alternatively, the central graft material  110  may be an oriented material, having a single direction where the tensile strength of the material is the highest. Oriented materials may include rectus fascia and/or fascia lata. Mesh strips  120 ,  130 , and  140  may be constructed of any materials acceptable for placement within humans that have suitable mechanical properties. While the materials need not be mesh, open materials such as mesh, weave, open fabrics, etc., allow for ingrowth of cellular material, thus stabilizing the implantable prolapse repair device  100 . In some embodiments, the mesh strips  120 ,  130 , and  140  may be constructed from polypropylene, polyethylene, polylactic acid (PLA), polyglycolic acid (PGA), poly-L-lactic acid (PLLA), polypeptides, combinations thereof, or other suitable materials. 
     As shown in  FIG. 2 , the first mesh strip  120  has a first free end  220 , including a first needle  223  attached thereto. The first mesh strip  120  also has second free end  225 , including a second needle  227  attached thereto. The second mesh strip  130  has free end  230 , including a needle  233  attached thereto, and a connector end  235 . The connector end  235  of the second mesh strip  130  is coupled to the first connection point  160  of the central graft material  110 . The third mesh strip  140  has a free end  240 , including a needle  243  attached thereto, and a connector end  245 . The connector end  245  of the third mesh strip  140  is coupled to the second connection point  170  of the central graft material  110 . As shown in  FIG. 2 , free ends  220 ,  225 ,  230 , and  240  may be arranged to extend outwardly from the central graft material  110 . The first mesh strip  120  may additionally include a reinforcing wire  228 , the second mesh strip  130  may additionally include a reinforcing wire  238 , and the third mesh strip  140  may additionally include a reinforcing wire  248 . The first mesh strip  120  may include a contiguous reinforcing wire, or multiple reinforcing wires to avoid pressure points along the central graft material  110 . Needles  223 ,  227 ,  233 ,  243  may be constructed of stainless steel, titanium, or other suitable materials. Needles  223 ,  227 ,  233 ,  243  need not be true needle structures, and may, for example, be small sharpened or blunt tips, as necessary to interface with implantation devices, such as CAPIO (Boston Scientific). 
     As shown in  FIG. 3 , the implantable prolapse device  100  may be sold as a prolapse repair kit  300 , comprising the central graft material  110 , the first mesh strip  120 , the second mesh strip  130 , and the third mesh strip  140 , as described above. In alternative embodiments, prolapse repair kit  300  may contain a singular piece of mesh (not shown) from which mesh strips  120 ,  130 , and  140  may be fabricated. For example, a singular piece of mesh with free ends with needles (or similar structures) attached thereto can be cut to create mesh strips  120 ,  130 , and  140 , and the newly-fabricated mesh strips incorporated into an implantable prolapse repair kit of the invention. 
     In some embodiments, elements of the prolapse repair kit  300  may be separately packaged because of separate storage needs, e.g., the central graft material  110  may need to stay hydrated in saline, and thus, is not packaged with mesh strips  120 ,  130 , or  140 . In other embodiments, pieces of the prolapse repair kit may be sold separately, with the surgeon being instructed how to assemble the pieces to create an implantable prolapse repair device according to the invention. 
     The implantable prolapse repair device  100  is assembled from the prolapse repair kit  300  by passing the first mesh strip  120  through the central graft material  110  using the at least two slits  150 , thereby forming the supportive weave  180 . In the illustrated embodiment, the anchor suture  190  is used to couple the first mesh strip  120  and the central graft material  110  to restrict motion there between, although in further embodiments an anchor suture may not be necessary. The first mesh strip  120  is arranged such that the first free end  220  and the second free end  225  extend outwardly from the central graft material  110 , as is shown in  FIG. 2 . Next, the connector end  235  of the second mesh strip  130  is coupled to the first connection point  160  of the central graft material  110  such that the free end  230  of the second mesh strip  130  extends outwardly from the central graft material  110 , as is shown in  FIG. 2 . Finally, the connector end  245  of the third mesh strip  140  is coupled to the second connection point  170  of the central graft material  110  such that the free end  240  of the third mesh strip  140  extends outwardly from the central graft material  110 , as is shown in  FIG. 2 , thereby producing a complete implantable prolapse repair device  100 . 
     In the illustrated embodiment, each of the connections points  160 ,  170  are slits formed in the central graft material  110 . The second and third mesh strips  130 ,  140  are coupled to the central graft material  110  by looping mesh strips  130 ,  140  through the connection points  160 ,  170 . Each of the connector ends  235 ,  245  are passed through the respective connection points  160 ,  170 . Each of the free ends  230 ,  240  of mesh strips  130 ,  140  is passed through an opening formed in the respective connector end  235 ,  245  to couple mesh strips  130 ,  140  to the central graft material  110 . In further embodiments, the mesh strips  130 ,  140  are coupled to the central graft material  110  by other known means. 
     An implantable prolapse repair device according to the invention may be used to repair prolapsed organs in the female pelvis using the following technique: The patient is placed in the dorsal lithomy position and is prepped and draped as standard. An incision is made in the anterior vaginal wall below the level of the vaginal muscularis to maintain a vascularized epithelium. A finger is inserted through the incision to create a dissection plane. At this point, one or more optional site-specific repairs such as a midline vaginal defect repair, paravaginal plication of the anterior wall, a posterior repair of the rectovaginal fascia, or a repair of the pubocervical fascia, can be performed. These repairs, typically done with absorbable suture, can be completed prior to implanting the prolapse repair device. Additionally, these repairs are often advisable when the repair device incorporates a central graft material containing dermis, decellularized animal tissue or other similar material. 
     Next, an implantable prolapse repair device is inserted through the incision in the vaginal wall, and a cephalad end  270  of the central graft material  110  is affixed to the cervix or vaginal cuff. The central graft material is attached such that when the prolapse repair device is placed, the supportive weave will be separated from the vaginal wall by the central graft material. A CAPIO Device (Boston Scientific, Natick Mass.) is then loaded with the needle attached to first mesh strip free first end  223 . A sacrospinous ligament  440  on the corresponding side of the patient is located by dissecting with a finger. The CAPIO device is then located adjacent to the finger, contacting the sacrospinous ligament  440 , and activated, causing the needle attached to first mesh strip first free end  223  to pass through the sacrospinous ligament  440  as illustrated in  FIG. 4A , resulting in the first mesh strip  120  being coupled to the sacrospinous ligament  440 . In a similar fashion, the needle attached to first mesh strip second free end  227  is attached to a contralateral sacrospinous ligament  450 . A suture can be placed through a central portion of the mesh and a central portion of the cervix or vaginal cuff in order to prevent and/or lessen the likelihood of slippage of the graft from the apex of the vagina. 
     Following attachment of the first strip  120  to the sacrospinous ligaments  440  and  450 , the finger is used to locate an arcus tendineous  460  in order to secure the second mesh strip  130 . The CAPIO device is again located adjacent to the finger, contacting the arcus tendineous  460 , and activated, causing the needle attached to the second mesh strip free end  233  to pass through arcus tendineous  460 , as illustrated in  FIG. 4B , resulting in second mesh strip  130  being coupled to the arcus tendineous  460 . In a similar fashion, the needle attached to the third mesh strip free end  243  is attached to a contralateral arcus tendineous  470 . At this point, the strips  120 ,  130 ,  140 , may be adjusted to achieve the desired support, and free ends  220 ,  225 ,  230 , and  240  trimmed and removed from the patient. Prior to closing the incision, a caudal portion  280  of the central graft material  110  is sutured to the caudal portion of the anterior dissection. The vaginal incision is then closed with suture. 
     In a similar fashion, the implantable prolapse repair device  100  may be placed via a posterior vaginal incision. Additionally, an embodiment (not shown) of the repair device of  FIG. 1-2  is presented absent the left and right Arcus mesh arms. Without these arms, complications from mesh placement may be reduced. Use of the device with or without the right and left arcus mesh arms can be selected based upon a surgeon&#39;s preference and/or based upon a particular patient&#39;s medical condition. The alternative embodiment can include a substantially smaller portion of the central graft material  110 , and can be prefabricated or cut to the desired dimensions by the surgeon. 
     The central graft material  110  and mesh strips  120 ,  130 , and  140  may include one or more agents for release into a patient&#39;s tissues. In one embodiment, the agent may be a tissue growth factor that, when applied to the patient&#39;s tissues in a pharmaceutically acceptable amount, promotes well-organized collagenous tissue growth, such as scar tissue growth, preferably, in large quantities. According to one feature, the agent may or may not block or delay the dissolvability of the biodegradable materials. Whether or not an agent blocks or delays such dissolvability may be controlled by selecting differing methods for loading the agent onto the sling. Exemplary tissue growth factors may include natural and/or recombinant proteins for stimulating a tissue response to enhance collagenous tissue growth. Exemplary growth factors that may be used include, but are not limited to, platelet-derived growth factor (PDGF), fibroblast growth factor (FGF), transforming growth factor-beta (TGF-beta), vascular endothelium growth factor (VEGF), Activin/TGF and sex steroid, bone marrow growth factor, growth hormone, Insulin-like growth factor 1, and combinations thereof. The agent may also include a hormone, including but not limited to estrogen, steroid hormones, and other hormones to promote growth of appropriate collagenous tissue such as scar tissue. The agent may also include stem cells or other suitable cells derived from the host patient. These cells may be fibroblast, myoblast, or other progenitor cells to mature into appropriate tissues. 
     In some embodiments, the agent may additionally comprise one or more therapeutic agents. The therapeutic agents may be, for example, anti-inflammatory agents, including steroidal and non-steroidal anti-inflammatory agents, analgesic agents, including narcotic and non-narcotic analgesics, local anesthetic agents, antispasmodic agents, growth factors, gene-based therapeutic agents, and combinations thereof. Exemplary steroidal anti-inflammatory therapeutic agents (glucocorticoids) include, but are not limited to, 21-acetoxyprefnenolone, aalclometasone, algestone, amicinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumehtasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halobetasol priopionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methyolprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylaminoacetate, prednisone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortal, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, and pharmaceutically acceptable salts thereof. 
     Exemplary non-steroidal anti-inflammatory therapeutic agents include, but are not limited to, aminoarylcarboxylic acid derivatives such as enfenamic acid, etofenamate, flufenamic acid, isonixin, meclofenamic acid, mefanamic acid, niflumic acid, talniflumate, terofenamate and tolfenamic acid; arylacetic acid derivatives such as acemetacin, alclofenac, amfenac, bufexamac, cinmetacin, clopirac, diclofenac sodium, etodolac, felbinac, fenclofenac, fenclorac, fenclozic acid, fentiazac, glucametacin, ibufenac, indomethacin, isofezolac, isoxepac, lonazolac, metiazinic acid, oxametacine, proglumetacin, sulindac, tiaramide, tolmetin and zomepirac; arylbutyric acid derivatives such as bumadizon, butibufen, fenbufen and xenbucin; arylcarboxylic acids such as clidanac, ketorolac and tinoridine; arylpropionic acid derivatives such as alminoprofen, benoxaprofen, bucloxic acid; carprofen, fenoprofen, flunoxaprofen, flurbiprofen, ibuprofen, ibuproxam, indoprofen, ketoprofen, loxoprofen, miroprofen, naproxen, oxaprozin, piketoprofen, pirprofen, pranoprofen, protizinic acid, suprofen and tiaprofenic acid; pyrazoles such as difenamizole and epirizole; pyrazolones such as apazone, benzpiperylon, feprazone, mofebutazone, morazone, oxyphenbutazone, phenybutazone, pipebuzone, propyphenazone, ramifenazone, suxibuzone and thiazolinobutazone; salicylic acid derivatives such as acetaminosalol, aspirin, benorylate, bromosaligenin, calcium acetylsalicylate, diflunisal, etersalate, fendosal, gentisic acid, glycol salicylate, imidazole salicylate, lysine acetylsalicylate, mesalamine, morpholine salicylate, 1-naphthyl salicylate, olsalazine, parsalmide, phenyl acetylsalicylate, phenyl salicylate, salacetamide, salicylamine o-acetic acid, salicylsulfuric acid, salsalate and sulfasalazine; thiazinecarboxamides such as droxicam, isoxicam, piroxicam and tenoxicam; others such as c-acetamidocaproic acid, s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amixetrine, bendazac, benzydamine, bucolome, difenpiramide, ditazol, emorfazone, guaiazulene, nabumetone, nimesulide, orgotein, oxaceprol, paranyline, perisoxal, pifoxime, proquazone, proxazole and tenidap; and pharmaceutically acceptable salts thereof. 
     Exemplary narcotic analgesic therapeutic agents include, but are not limited to, alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, codeine methyl bromide, codeine phosphate, codeine sulfate, desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, fentanyl, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levorphanol, lofentanil, meperidine, meptazinol, metazocine, methadone hydrochloride, metopon, morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone, papavereturn, pentazocine, phenadoxone, phenazocine, pheoperidine, piminodine, piritramide, proheptazine, promedol, properidine, propiram, propoxyphene, rumifentanil, sufentanil, tilidine, and pharmaceutically acceptable salts thereof. 
     Exemplary non-narcotic analgesic agents that may be combined with the slings of the invention include, but are not limited to, aceclofenac, acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid, alclofenac, alminoprofen, aloxiprin, aluminum bis(acetylsalicylate), aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine, ammonium salicylate, amtolmetin guacil, antipyrine, antipyrine salicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen, benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide, 5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin, calcium acetylsalicylate, carbamazepine, carbiphene, carsalam, chloralantipyrine, chlorthenoxazin(e), choline salicylate, cinchophen, ciramadol, clometacin, cropropamide, crotethamide, dexoxadrol, difenamizole, diflunisal, dihydroxyaluminum acetylsalicylate, dipyrocetyl, dipyrone, emorfazone, enfenamic acid, epirizole, etersalate, ethenzamide, ethoxazene, etodolac, felbinac, fenoprofen, floctafenine, flufenamic acid, fluoresone, flupirtine, fluproquazone, flurbiprofen, fosfosal, gentisic acid, glafenine, ibufenac, imidazole salicylate, indomethacin, indoprofen, isofezolac, isoladol, isonixin, ketoprofen, ketorolac, p-lactophenetide, lefetamine, loxoprofen, lysine acetylsalicylate, magnesium acetylsalicylate, methotrimeprazine, metofoline, miroprofen, morazone, morpholine salicylate, naproxen, nefopam, nifenazone, 5′ nitro-2′ propoxyacetanilide, parsalmide, perisoxal, phenacetin, phenazopyridine hydrochloride, phenocoll, phenopyrazone, phenyl acetylsalicylate, phenyl salicylate, phenyramidol, pipebuzone, piperylone, prodilidine, propacetamol, propyphenazone, proxazole, quinine salicylate, ramifenazone, rimazolium metilsulfate, salacetamide, salicin, salicylamide, salicylamide o-acetic acid, salicylsulfuric acid, salsalte, salverine, simetride, sodium salicylate, sulfamipyrine, suprofen, talniflumate, tenoxicam, terofenamate, tetradrine, tinoridine, tolfenamic acid, tolpronine, tramadol, viminol, xenbucin, zomepirac, and pharmaceutically acceptable salts thereof. 
     Exemplary local anesthetic therapeutic agents include, but are not limited to, ambucaine, amolanone, amylocalne hydrochloride, benoxinate, benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, butaben, butanilicaine, butethamine, butoxycaine, carticaine, chloroprocaine hydrochloride, cocaethylene, cocaine, cyclomethycaine, dibucaine hydrochloride, dimethisoquin, dimethocaine, diperadon hydrochloride, dyclonine, ecgonidine, ecgonine, ethyl chloride, beta-eucaine, euprocin, fenalcomine, fomocaine, hexylcaine hydrochloride, hydroxytetracaine, isobutyl p-aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine, mepivacaine, meprylcaine, metabutoxycaine, methyl chloride, myrtecaine, naepaine, octacaine, orthocaine, oxethazaine, parethoxycaine, phenacaine hydrochloride, phenol, piperocaine, piridocaine, polidocanol, pramoxine, prilocalne, procaine, propanocaine, proparacaine, propipocaine, propoxycaine hydrochloride, pseudococaine, pyrrocaine, ropavacaine, salicyl alcohol, tetracaine hydrochloride, tolycaine, trimecaine, zolamine, and pharmaceutically acceptable salts thereof. 
     Exemplary antispasmodic therapeutic agents include, but are not limited to, alibendol, ambucetamide, aminopromazine, apoatropine, bevonium methyl sulfate, bietamiverine, butaverine, butropium bromide, n-butylscopolammonium bromide, caroverine, cimetropium bromide, cinnamedrine, clebopride, coniine hydrobromide, coniine hydrochloride, cyclonium iodide, difemerine, diisopromine, dioxaphetyl butyrate, diponium bromide, drofenine, emepronium bromide, ethaverine, feclemine, fenalamide, fenoverine, fenpiprane, fenpiverinium bromide, fentonium bromide, flavoxate, flopropione, gluconic acid, guaiactamine, hydramitrazine, hymecromone, leiopyrrole, mebeverine, moxaverine, nafiverine, octamylamine, octaverine, oxybutynin chloride, pentapiperide, phenamacide hydrochloride, phloroglucinol, pinaverium bromide, piperilate, pipoxolan hydrochloride, pramiverin, prifinium bromide, properidine, propivane, propyromazine, prozapine, racefemine, rociverine, spasmolytol, stilonium iodide, sultroponium, tiemonium iodide, tiquizium bromide, tiropramide, trepibutone, tricromyl, trifolium, trimebutine, n,n-ltrimethyl-3,3-diphenyl-propylamine, tropenzile, trospium chloride, xenytropium bromide, and pharmaceutically acceptable salts thereof. 
     The implantable prolapse repair device  100  is expected to have favorable long-term outcomes when implanted as described above. One improvement over the existing prolapse repair devices, such as described in U.S. Published Patent Application No. 2008/0081945, is the use of the supportive weave  180 , which allows the implantable prolapse repair device  100  to provide mesh-like support to prolapsed organs (e.g., vagina, bladder, rectum, uterus) while not actually contacting the vaginal wall with mesh material. In particular, benefits are anticipated when the supportive weave is spaced apart from the vaginal wall by the central graft material. Such an arrangement provides improved support with reduced risk of erosion. Additionally, the prior attachment of needles to free ends  220 ,  225 ,  230 , and  240  allows for fast and accurate implantation. Other benefits may include lower incidence of post-operative bleeding, infection, and re-operation. 
     EXAMPLES 
     Example 1 
     Prolapse Repair Using Implantable Prolapse Repair Device 
     A 68-year-old woman presented with complaints of urinary discomfort and incontinence. A pelvic exam indicated anterior vaginal wall prolapse. After pre-op and prep, a longitudinal anterior vaginal incision was made and a dissection plane was established with sharp and blunt disection. Prior to implanting the prolapse repair device, a site specific repair was performed, repairing the pubocervical fascial defect using absorbable suture. Following the fascial repair, an implantable prolapse repair device similar to the device shown in  FIG. 2  was placed beyond the dissection plane, and the cephalad end of the central graft material was attached to the midline of the vaginal cuff with suture. Following attachment of the cephalad end, the free ends of the first mesh strip were passed through the left and right sacrospinous ligaments, using the attached needles, by using a CAPIO Device (Boston Scientific, Natick, Mass.). The central area of the mesh was sutured to the midline of the vaginal cuff. Next, the free ends of the second and third mesh strips were passed through the left and right arcus tendineous using the corresponding attached needles and a CAPIO Device. The free ends were then trimmed and the remnant free ends removed. After securing the free ends, the caudal end of the central graft material was attached to the caudal end of the anterior dissection, and the incision closed. The patient stayed overnight at the hospital for observation and rested at home for approximately two weeks before resuming light activities. Eleven months post-operative, the patient reports no abnormal bleeding, discharge and no pain. No complications are known. 
     Example 2 
     Results of 19 Prolapse Repair Procedures 
     Using the techniques described in EXAMPLE 1, nineteen women of varying age, presenting Stage II or greater vaginal prolapse, underwent repair procedures without concurrent hysterectomy. The results are summarized in Table 1. 
     
       
         
           
               
             
               
                 TABLE 1 
               
             
            
               
                   
               
               
                 Summary of prolapse repair procedures using the invention 
               
               
                 after 2 years. 
               
            
           
           
               
               
               
               
               
            
               
                 Patient 
                 Age 
                 Repair 
                 Months Post 
                 Known Complications 
               
               
                   
               
            
           
           
               
               
               
               
               
            
               
                 1 
                 79 
                 Anterior 
                 23 
                 None 
               
               
                 2 
                 68 
                 Anterior 
                 23 
                 Skin Dehiscence (1) 
               
               
                 3 
                 76 
                 Anterior 
                 22 
                 Recurrent prolapse (2) 
               
               
                 4 
                 48 
                 Anterior 
                 20 
                 Recurrent prolapse (3) 
               
               
                 5 
                 56 
                 Anterior 
                 20 
                 None 
               
               
                 6 
                 61 
                 Anterior 
                 20 
                 None 
               
               
                 7 
                 41 
                 Anterior 
                 21 
                 Erosion(4) 
               
               
                 8 
                 58 
                 Anterior 
                 18 
                 None 
               
               
                 9 
                 81 
                 Anterior 
                 18 
                 None 
               
               
                 10 
                 70 
                 Posterior 
                 14 
                 None 
               
               
                 11 
                 63 
                 Anterior 
                 17 
                 None 
               
               
                 12 
                 77 
                 Anterior 
                 15 
                 None 
               
               
                 13 
                 57 
                 Anterior 
                 13 
                 None 
               
               
                 14 
                 69 
                 Anterior 
                 11 
                 None 
               
               
                 15 
                 66 
                 Anterior 
                 11 
                 None 
               
               
                 16 
                 73 
                 Anterior 
                 11 
                 None 
               
               
                 17 
                 69 
                 Anterior 
                 11 
                 None 
               
               
                 18 
                 79 
                 Anterior 
                 11 
                 None 
               
               
                 19 
                 76 
                 Posterior 
                 10 
                 None 
               
               
                 20 
                 78 
                 Anterior 
                 9 
                 None 
               
               
                 21 
                 77 
                 Anterior 
                 7 
                 Skin Dehiscence (5) 
               
               
                 22 
                 75 
                 Anterior 
                 4 
                 None 
               
               
                 23 
                 66 
                 Anterior 
                 3 
                 Skin Dehiscence (6) 
               
               
                   
               
            
           
         
       
     
     Overall, the results are encouraging. Patient follow-up indicates fewer mesh erosions than would be expected from a similar patient population undergoing mesh-only prolapse repair. Nonetheless, patients reported apical support similar to that provided by mesh-only systems. Patients 1, 21 and 23 each presented within 6 weeks post procedure with increased discharge and were noted to have 3 cm or less skin separation exposing the dermis without mesh erosions. These patients all resolved with oral or vaginal antibiotics. Patient 3, a 76 year old, presented at 14 months post procedure with a recurrent cystocele. The apex was well supported. A subsequent surgical repair was done to successfully repair the cystocele. Patient 4, a 48 year old, experienced a severe cough immediately after surgery and recurrence was noted at 6 weeks post procedure. The cervix was elongated. At 20 months, the patient had a total vaginal and uterosacral ligament fixation. Patient 7, a 41 year old, was found to have an apical mesh erosion at 6 weeks post procedure and this was corrected by removing the exposed mesh in the midline, at an office visit soon thereafter, the right arcus tendineus mesh attachment was removed in the operating room. 
     The singular mesh erosion noted in Table 1 was corrected by removing the exposed mesh during an office visit; the patient did not experience any recurrent anatomical failure thereafter. The recurrent anterior prolapse noted in Table 1 required re-operation and placement of new mesh over the anterior vaginal wall. The new mesh was attached to the cephalad mesh from the prior procedure, which remained affixed to the sacrospinous ligaments. 
     During the prodcedures listed in Table 1 there were no serious complications, such as large vessel injuries leading to hemorrhage, nerve injury, or serious infection. The patients experienced no significant post-operative chronic pain associated with graft placement. The patients represented in Table 1 have not reported any urinary retention as a result of the repair. 
     Thus, the invention provides, among other things, an implantable prolapse repair device, a method of using a prolapse repair device, a kit containing a prolapse repair device, and a method of making a prolapse repair device. Various features and advantages of the invention are set forth in the following claims.