LEVATOR FOR REPAIR OF PERINEAL PROLAPSE

Abstract

Improved methods and apparatuses for treatment of pelvic organ prolapse are provided. A specialized mesh having a shape for effective placement via the ischiorectal fossa is provided, as is a method of use of such a device.

Claims

1. A method of treating pelvic organ prolapse, said method comprising the placement of a mesh implant to provide support for levator ani muscles.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] 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:

[0021] FIG. 1 shows the anatomy of the pelvic floor, including the pubococcygeus muscles and iliococcygeus muscles that make up the levator ani muscles.

[0022] FIG. 2 shows a schematic illustrating the general condition of healthy levator muscles.

[0023] FIG. 3 shows a schematic illustrating the general condition of levators associated with prolapsed pelvic organs.

[0024] FIG. 4 shows the anatomy of the ischiorectal fossa (though in a male).

[0025] FIG. 5 shows an embodiment of the mesh implant of the present invention.

[0026] FIG. 6 shows an overview of the anatomical placement of the implant of the present invention.

[0027] FIG. 7 shows the location of the method of the present invention.

[0028] FIGS. 8 and 9 show the anatomical placement of the present invention.

[0029] FIG. 10 shows the anatomy of the pelvic floor.

DETAILED DESCRIPTION

[0030] Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views. The following description is meant to be illustrative only, and not limiting other embodiments of this invention will be apparent to those of ordinary skill in the art in view of this description.

[0031] The relevant anatomy is illustrated in FIG. 1. As can be seen, the levator ani muscles, including the pubococcygeus and iliococcygeus muscles, are a significant portion of the pelvic floor and provide support for the pelvic viscera, FIGS. 1 and 2 show the normal condition of the levator muscles, while FIG. 3 shows the posture of levator muscles associated with prolapsed pelvic organs. As can be seen, such muscles offer less support for the pelvic viscera and may benefit from additional support as provided in the present invention. Further, laxity of such muscles is thought to result in an increased size of the normal opening in the muscles at the urogenital hiatus. With this increased size, there is a tendency of the organs in the anatomical vicinity to fill the opening. This would explain some degree of prolapse. However, this degree of prolapse caused by the organs filing the open space in the pelvic floor, can lead to increased stress on the normal fascia supports for these organs. This leads to failure of this connective tissue, resulting in further prolapse through the pelvic floor opening.

[0032] In the present invention, an implant is placed in position to support the levator muscle in a tension-free manner. The implant is placed via the ischiorectal fossa. The ischiorectal fossa is seen in FIG. 4. It is somewhat prismatic in shape, with its base directed to the surface of the perineum, and its apex at the line of meeting of the obturator and anal fascia. It is bounded medially by the external anal sphincter and the anal fascia. Laterally, it is bounded by the ischial tuberosity and the obturator fascia. It is bounded anteriorly by the fascia of Colles covering the transverse superficial perineal muscle, and by the inferior fascia of the urogenital diaphragm. Posteriorly, the fossa is bound by the gluteus maximus and the sacrotuberous ligament. Crossing the space transversely are the inferior hemorrhoidal vessels and nerves. At the back part are the perineal and perforating cutaneous branches of the pudendal plexus. From the front, the posterior labial vessels and nerves emerge. The internal pudendal vessels and pudendal nerve lie in Alcock's canal on the lateral wall. The fossa is filled with fatty tissue across which numerous fibrous bands extend from side to side.

[0033] The implant may be of any shape suitable for providing adequate support of the Levator musculature. In a preferred embodiment, seen in FIG. 5, the implant includes a central support portion 1 having a trapezoidal shape, with a width of a first side 2 on the base of the trapezoid being less than a width of a second side 3 opposite the base. The implant may have lateral sides 4 and 5 having substantially the same length.

[0034] The implant preferably comprises a pair of arms 6 and 7 extending from points near the junction of second side 3 and lateral sides 4 and 5, respectively.

[0035] The implant of the present invention may be made of a synthetic or non-synthetic material, or a combination thereof. Suitable non-synthetic materials include allografts, homografts, heterografts, autologous tissues, cadaveric fascia, autodennal grafts, dermal collagen grafts, autofascial heterografts, whole skin grafts, porcine dermal collagen, lyophilized aortic homografts, preserved dural homografts, bovine pericardium and fascia lata. Commercial examples of 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 terephthalate) Hernia Mesh also available from Ethicon. Gore-Tex (expanded polytetrafluoroethylene) available from W.L. Gore and Associates, Phoenix, Ariz., and the polypropylene sling available in the SPARC sling system, 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.

[0036] Other examples of suitable materials include those disclosed in published U.S. Patent Application No. 2002/0072694, herein incorporated by reference. More specific examples of synthetic materials include, but are not limited to, polypropylene, cellulose, polyvinyl, silicone, polytetrafluoroethylene, polyglactin, 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. See Cervigni et al., The Use of Synthetics in the Treatment of Pelvic Organ Prolapse, Current Opinion in Urology (2001), 11: 429-435.

[0037] U.S. Publication No. 2005/0245787, U.S. Publication No. 2005/0250977, U.S. Pat. No. 6,802,807, U.S. Pat. No. 6,911,003, U.S. Pat. No. 7,048,682, and U.S. Pat. No. 6,971,986 are herein incorporated by reference.

[0038] In a preferred embodiment, a suitable delivery needle is attached to a first end portion of said implant. An initial incision is made at a point between the anus and the tip of the coccyx. The relationship between the coccyx and the other structures of the pelvic floor is seen in FIG. 10. Following the incision, the tendon of insertion of the levator ani muscle, at the coccyx, is cut. Following this cut, the surgeon bluntly dissects a space for placement of the present implant lateral to the levator muscles. This dissection may require the use of pillow dissection with placement of a balloon device, followed by inflation of such a balloon to create the required space.

[0039] Following the creation of a space on a first side of the levator muscle, the implant of the present invention is attached to a suitable needle. The mesh is placed lateral to the muscle. In a preferred embodiment, the mesh is attached to the obturator internus muscle adjacent to the pubic ramus. The mesh is further attached adjacent the ischial spine into the sacrospinous ligament. The trapezoidal mesh is then draped underneath the ano-rectal junction into the ischiorectal fossa, emerging on the contralateral side of the first and second attachments. The mesh implant is then attached to the obturator internus muscle adjacent to the pubic ramus on the contralateral side of the patient, and adjacent the ischial spine into the sacrospinous ligament on the contralateral side.

[0040] 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 otherwise than as specifically described herein.