Surgery – Internal organ support or sling
Reexamination Certificate
2001-02-02
2004-02-03
Mancene, Gene (Department: 3736)
Surgery
Internal organ support or sling
C600S029000, C600S030000
Reexamination Certificate
active
06685626
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to compositions, devices, methods and kits that are useful in surgical procedures, specifically to induce adhesions for the purposes of stabilizing implants, closing apertures, and otherwise promoting the adhesion of implants and anatomical structures to one another.
BACKGROUND OF THE INVENTION
In the medical art, an adhesion is “a band of scar tissue that binds together two anatomic structures that normally are separate from each other.” (Mosby's Medical, Nursing, & Allied Health Dictionary, Ed. 5, 1998). An adhesion may form in the body as a result of surgery, most commonly in the abdomen, due to inflammation, or due to injury. As used herein, the term “adhesion” is used to define fibrous tissue induced to form between a surgically introduced implant and an adjacent body part (tissue or organ area), or between adjacent body parts.
The field of surgery has long recognized problems caused by undesired formation of surgical adhesions, and technologies and strategies have been developed to minimize, reduce, or repair deleterious surgical adhesions. Among examples of efforts to deal with the undesired effects of surgical adhesions are U.S. Pat. Nos. 6,034,088 (Reeve et al.) and 6,086,907 (Goldberg et al.).
In contrast to these inventions, some inventions are directed to specific methods for forming adhesions or adhesion-like binding for beneficial purposes. For instance, U.S. Pat. No. 5,549,904 (Juergensen et al.) discloses and claims a biological adhesive composition employing as the key ingredient a tissue transglutaminase enzyme. This enzyme has been found to promote adhesion between tissue surfaces. U.S. Pat. Nos. 5,219,895, 5,354,336, and 5,874,537 (all by Kelman et al.), disclosed and claimed specific collagen-based compositions and related methods, where the collagen was polymerizable. A collagen-based composition was applied to an area of a patient needing adhesion of adjacent tissues, and after application the collagen was polymerized to adhere the tissues. Polymerization could occur a number of ways, including through ultraviolet light exposure. The disclosures of these patents are hereby incorporated by reference to show the state of the art prior to this invention.
In contrast to the formation of undesired surgical adhesions, the present invention recognizes a need in the art to induce adhesions at specific regions for a range of surgically useful applications. In contrast to the above referenced patents by Juergensen et al. and Kelman et al., the adhesions of the present invention are promoted at specific sites by means of introducing one or more particulate materials that promote the formation of an adhesion, where that adhesion has characteristics similar to a non-intentionally formed adhesion. The particulate materials are presented in various compositions which may include adhesives, binders, promoters, and the like, and may also include enzymes. The primary purpose for such intentional adhesions is to assure proper attachment and alignment between an implant and a body part, or a body part and another body part. The present invention provides compositions, devices, methods, and kits to provide for the promotion of adhesions where such adhesions are beneficial.
For instance, in the surgical procedure of implanting a bladder sling, the procedure has been known to fail in its desired effect, namely to exert pressure against the urethra and the bladder, to alleviate or prevent incontinence. This failure can result from slippage of the sling adjacent the desired area. In such failure, a second operation may be required, resulting in additional risk, trauma, expense, and recovery period, still without assurance that subsequent slippage will not again render the procedure ineffective. Thus, the present invention provides devices, methods and compositions that promote the formation of one or more adhesions between the implant and the neck of the bladder or other implant material and biological structure.
One embodiment of the present invention is an implant that contains at least one area containing specific water-insoluble particles that induce formation of at least one adhesion. When such adhesion(s) develop, this greatly lessens the possibility of slippage of the sling or other implant, because the adhesion provides a substantial attachment between the implant and the intended contact area of the bladder or other biological structure. In a more general sense, the compositions, devices, methods, and kit of the present invention are utilizable in a number of applications, including the preparation of implants having specific areas with an adhesion-forming capability, and a range of surgical procedures where site-specific adhesion is desired and induced to form.
Other aspects of the present invention are also disclosed. Overall, the present invention represents an improvement in the field of implants, surgical materials, and surgery techniques. These improvements are mechanistically based on the conception of the usefulness of adhesion formation in specific applications, and the development of various means to accomplish formation of beneficial adhesions. However, it should be understood that the usefulness of the compositions, devices, methods, and kits for induction of adhesions disclosed herein is not to be construed as limited to this or on any proposed mechanism of the proposed physiological steps thought to be relevant to formation.
SUMMARY OF THE INVENTION
The present invention provides compositions, devices methods, and kits useful in the intentional promotion of adhesions. Novel materials, compositions, mixtures and methods are disclosed that promote the formation of adhesions when in contact with a tissue of a patient. Preparations for applying these materials so as to adhere to an implant, or in or on a tissue or organ area, are also disclosed. Methods of forming adhesions using these materials, mixtures, compositions and novel implants are also disclosed.
In one embodiment of this invention, a surgical implant is prepared, and the surgical implant comprises a generalized structure and at least one area treated with a preparation containing materials that promote an adhesion between that area and a tissue or organ region contacting that area. An associated surgical method places this implant in a patient in need thereof, such that an adhesion forms between the implant at that area and a specified tissue or organ region contacting that area.
Another embodiment of this invention is a method of preparing materials that promote an adhesion, and injecting a solution, slurry, mixture, or composition comprising that preparation into a tissue or organ, such that an adhesion subsequently forms. For instance, where it is desired to close the uterus for medical reasons, such solution and the like may be injected at or near the cervix, and consequent formation of an adhesion closes off the cervix, thereby closing the uterus.
Another embodiment of the present invention is a composition for application to a surgical implant, the composition preferably comprising hydroxyapatite particles and gelatin, where the gelatin adheres the hydroxyapatite particles to a desired section of an implant. In a preferred embodiment, for instance, this composition is applied to a center section of a bladder sling, that section being the area that would be placed next to the area of the urethra and bladder where an adhesion between the sling and that portion of the bladder sling is desired for stabilization.
Additional objects, advantages, and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
REFERENCES:
patent: 3988782 (1976-11-01), Dardik et al.
patent: 4243652 (1981-01-01), Francis
pa
McAndrews Held & Malloy Ltd.
Nicolas Frederick C.
Pochopien Donald J.
Regeneration Technologies, Inc.
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