Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
1998-09-30
2001-03-06
Buiz, Michael (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
Reexamination Certificate
active
06197036
ABSTRACT:
TECHNICAL FIELD
The present invention relates to patches for use in supporting tissues, organs, parts of organs, or other such anatomical structures. The patches may be used in a variety of pelvic floor reconstruction or stabilization procedures, including treatment of cystoceles, rectoceles, enteroceles, or enterocystoceles. More particularly, the present invention relates to prefabricated patches, methods of making the patches, and kits including the patches.
BACKGROUND INFORMATION
Damage to the pelvic floor is a serious medical condition which may occur during delivery or due to injury to the vesicovaginal fascia. Such an injury can result in a herniation of the bladder called a cystocele. Other similar conditions are known as rectoceles, enteroceles and enterocystoceles. A rectocele is a herniation of the rectum. An enterocele is formed when the intestine protrudes through a defect in the rectovaginal or vesicovaginal pouch and an enterocystocele is a double hernia in which both the bladder and the intestine protrude. These herniations are serious medical problems that can severely and negatively impact a patient both physiologically and psychologically.
Treatment of these conditions requires repositioning of the protruding organs or portions thereof. Existing tissue is often compromised facilitating the need to use a synthetic patch. Current medical procedures for repositioning the protruding organs or portions thereof may be time consuming or invasive. Hence, there is a need for reducing the amount of time which these procedures require and the invasiveness of the procedures.
SUMMARY OF THE INVENTION
The present invention relates to prefabricated repair patches, methods of making the patches, kits comprising the patches, and methods of using the patches to treat pelvic floor weakening and herniation, including cystoceles, rectoceles, and enteroceles.
One aspect of the invention features a prefabricated patch used in pelvic floor reconstruction procedures, including treatment of cystoceles, rectoceles, enteroceles and enterocystoceles. The patch is made of a natural or synthetic biocompatible material suitable for implantation into the body and has a plurality of apertures formed in a central portion of the patch.
Embodiments of this aspect of the invention can include the following features. For example, the natural or synthetic biocompatible material may be made of a material which facilitates tissue ingrowth, and it can have a plurality of interstices in which tissue ingrowth may occur. Also, the natural or synthetic biocompatible material may be adapted to be cleanly trimmed with scissors without generating sharp edges or spines. The synthetic biocompatible material can be absorbable, and it can be a woven or knitted material such as Hemashield® (available from Meadox Medical, 112 Bauer Drive, Oakland, N.J. 07436). In yet another embodiment of the patch, the natural or synthetic biocompatible material is coated. In some embodiments, the coating on the biocompatible material is absorbed after implantation to facilitate tissue ingrowth into the natural or synthetic biocompatible material. In another embodiment of the patch, the natural or synthetic biocompatible material is impregnated with an antibiotic. In one embodiment, the patch is impregnated with bacitracin. In another embodiment the patch is impregnated with polymixim. In another embodiment the patch is impregnated with neomycin. In some embodiments, the patch is capable of releasing a drug, and the drug can be released over time.
The plurality of apertures formed in the central portion of the patch provide enhanced vascularity and are adapted to permit rapid tissue ingrowth after the patch is installed. The apertures may also be used for pexing sutures. The apertures may be substantially circular. Preferably, the apertures are positioned on the patch at locations which reduce the likelihood of crumpling. For example, the apertures may be positioned at locations which lie outside of the force lines created when the patch is attached to a supporting anatomical structure or tissue. The apertures may be positioned at locations adapted to equalize the distribution of force on the patch when the patch is attached to a supporting anatomical structure or tissue. In one embodiment the apertures are also adapted for suture attachment or for allowing a suture to pass therethrough. In some embodiments, the material around the periphery of the apertures is reinforced. In other embodiments, the apertures are strengthened with a reinforcing device.
In some embodiments, the corners of the patch are adapted to receive a suture, thus serving as suture attachment sites. In other embodiments, the corners of the patch are adapted to receive more than one suture. In some embodiments, the sutures may be pre-attached to the patch.
In another aspect, the invention relates to a kit for performing a pelvic floor reconstruction or stabilization. The kit comprises a sterile natural or synthetic biocompatible material having a shape adapted for use in the procedures discussed above. The natural or synthetic biocompatible material has a plurality of apertures formed therein.
In one embodiment of the kit, the patch is packaged and both the patch and packaging are sterile. In another embodiment of the kit, the patch is a filamentous material coated with a coating to decrease the possibility of infection and/or increase biocompatibility. The coating can also include collagen or a polymeric material. In some embodiments, the coating may also include one or more drugs, for example and antibiotic, an immunosuppressant, and/or an anticoagulant. The packaging may be ultra-violet proof to protect the coating and/or drug.
Yet another aspect of the invention involves a method of making a patch for use in pelvic floor reconstruction procedures, such as those for treating cystoceles, rectoceles, enteroceles or cystoenteroceles. A natural or synthetic biocompatible material is cut into a shape adapted for pelvic floor stabilization and apertures are formed in the natural or synthetic biocompatible material. The material is typically sterilized, and a coating and/or drug can be applied to the material. The material can then be packaged.
In still another aspect, the invention features a method of stabilizing the pelvic floor. A patch is provided and it comprises a natural or synthetic biocompatible material having a shape adapted for pelvic floor reconstruction and a plurality of apertures formed in a central portion of the patch. One side of the patch is placed in contact with the tissue to be supported. The patch is secured to a supporting structure such as tissue, fascia, ligament, bone, muscle or other such anatomical structures having sufficient strength to allow the patch to be secured thereto without tearing the supporting structure. The supporting structure is located such that when the patch is secured thereto the herniated tissue is re-positioned in a location which alleviates the hernia. The force applied is sufficient to reposition the tissue in normal anatomical position. One embodiment of this method, the patch is secured by a at least one suture which is connected to a bone anchor which is attached to bone. In another embodiment, at least one suture can be attached to anatomical structures other than bone such as the arcus tendinous fascia pelvis, the ileal pectineal, or the pubococcygeous muscle complex.
In one embodiment, the method is a treatment for a cystocele and the tissue to be supported is the bladder or a portion thereof. The patch is placed in contact with the tissue beneath the bladder or portion thereof. The patch is connected to the supporting structure such that a biasing force is applied to the bladder or portion thereof to reposition the bladder or portion thereof such that the cystocele is alleviated. In further embodiments, the supporting structure may be the pubic bone, a ligament, or muscle tissue. The patch may be connected to the supporting structure through a suture or other fastener. In one embodiment, the suture or
Rackley Raymond
Tripp Hugh Adam
Buiz Michael
Sci-Med Life Systems, Inc.
Trinh Vikki
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