Drug – bio-affecting and body treating compositions – Embalming or undertaking compositions
Reexamination Certificate
2001-11-06
2003-02-18
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Embalming or undertaking compositions
Reexamination Certificate
active
06521221
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is directed to methods and compositions capable of rapidly preparing mammalian tissue and organs for harvesting and subsequent transplantation while minimizing the potential for infection of the harvested tissues and organs. This invention is also directed to methods and compositions used to prepare the donor for subsequent handling by a mortician.
2. References
The following publications, patent applications and patents are cited in this application as superscript numbers:
1
Barley, “
Methods for Retarding Blister Formation by Use of Cyanoacrylate Adhesives
”, U.S. Pat. No. 5,306,490, issued Apr. 26, 1994.
2
Barley, et al.,
Methods for Treating Suturable Wounds by Use of Sutures and Cyanoacrylate Adhesives
, U.S. Pat. No. 5,254,132, issued Oct. 19, 1993
3
McIntire, et al.,
Process for the Preparation of Poly
(&agr;-
Cyanoacrylates
), U.S. Pat. No. 3,654,239, issued Apr. 4, 1972
4
Barley, et al., International Patent Application Publication No. WO 93/25196, for
Methods for Treating Non-Suturable Wounds by Use of Cyanoacrylate Adhesives
, published Dec. 23, 1993
5
Barley, et al.,
Methods for Reducing Skin Irritation From Artificial Devices by Use of Cyanoacrylate Adhesives
, U.S. Pat. No. 5,653,769, issued Aug. 5, 1997
6
Tighe, et al.,
Methods for Inhibiting Skin Ulceration by Use of Cyanoacrylate Adhesives
, U.S. Pat. No. 5,403,591, issued Apr. 4, 1995
7
Tighe, et al., for
Use of Cyanoacrylates for Providing a Protective Barrier Film for the Skin
, U.S. Pat. No. 5,580,565, issued Dec. 6, 1996
8
Askill, et al., for
Methods for Draping Surgical Incision Sites
, U.S. Pat. No. 5,807,563 issued Sep. 15, 1998
All of the above publications, patent applications and patents are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent application or patent was specifically and individually indicated to be incorporated by reference in its entirety.
State of the Art
The procedures for harvesting tissues and organs for transplantation, implantation, research and other medical uses are fraught with complications which can cause reluctance to approve the use of the deceased in a donor program and limit the utility of the recovered tissues. Among these complications are infection of the removed tissues as well as ensuring that the donor's body is cosmetically acceptable after removal of the desired tissues and/or organs.
The infection rate for harvested tissues is approximately 30% despite extensive anti-infective procedures during organ and/or tissue harvest. After treatment of the harvested tissues and organs, there are approximately 10% that remain unusable due to infection.
Current practice in human cadavers is to first prepare the skin for subsequent tissue and/or organ harvesting by use of alcohol washes, followed by iodophor scrubs such as Betadine, followed by draping the incision site with a surgical incise drape such as Ioban. Such procedures are time consuming and expensive and all of the preparations have to be removed and all incisions have to be repaired to make the donor cosmetically presentable to family and friends.
Sutures and staples are frequently used for incision closures in human cadavers, but without the hemostasis mechanisms present in living tissue, mechanical closure will not prevent egress of body fluids. Commercial superglues, such as ethyl cyanoacrylate, are sometimes used to seal these incisions but the resulting polymer is too brittle and can easily crack whereas the reactive monomer can react too quickly making it hard to control. These superglues also have an unpleasant sharp odor and are respiratory irritants.
This invention is directed, in part, to the discovery that the in situ formation of a cyanoacrylate polymeric film at the site of tissue and/or organ harvesting overcomes many of the prior art problems noted above. For example, the cyanoacrylate polymer is known in the art to have bacteriostatic properties and the cyanoacrylate monomer permits the inclusion of compatible antimicrobial agents if such is desired. Still another advantage is the formation of an appropriately configured film which completely covers the transplantation area and forms a waterproof film over the skin, thereby inhibiting infection. Subsequent to tissue and/or organ harvesting, the reformation of the polymeric film over the incision site prevents fluid loss as well as improves the cosmetic appearance of the donor. Finally, the use of suitable cyanoacrylates with or without an appropriate perfume overcomes prior art problems with unpleasant odors and respiratory irritants.
The use of cyanoacrylate polymers per this invention is in contrast to their known medical uses as an alternative or adjunct to sutures
2
or as a hemostat
3
. Other described uses of cyanoacrylate prepolymers include their use on mammalian tissue to form polymeric films which are utilized:
to prevent friction blister formation
1
,
in treating small non-suturable wounds
4
,
in inhibiting surface skin irritation arising from friction between the skin surface and artificial devices such as tapes, prosthetic devices, casts, etc.
5
,
as surgical incise drapes
8
,
in inhibiting skin ulcerations
6
, and
forming a protective film to inhibit skin degradation due to incontinence.
7
SUMMARY OF THE INVENTION
This invention is directed to methods for the rapid and effective preparation of donor skin for tissue and/or organ transplation by the in situ formation of a cyanoacrylate film from a cyanoacrylate prepolymer. A film-forming cyanoacrylate prepolymer can also be used to seal incisions and tissue/organ harvest sites so as to restore mechanical integrity and prevent fluid leakage from these sites. Preferably, the cyanoacrylate prepolymer compositions contain an antimicrobial agent or a plurality of agents to further inhibit infection in the harvested tissue and/or organs.
Such methods involve application of a cyanoacrylate prepolymer composition onto the cadaver skin at the site of tissue and/or organ transplantation followed by in situ polymerization of the prepolymer to form a polymeric film. The cyanoacrylate prepolymer composition can be applied as a liquid/gel to the skin surface and can include antimicrobial agents, and the like. Subsequent to formation of the cyanoacrylate film, an incision is made there through and the appropriate tissues/organs are harvested. In a particularly preferred embodiment, a cyanoacrylate prepolymer is then used to seal incisions and tissue/organ harvest sites so as to restore mechanical integrity to the cadaver and/or to prevent fluid leakage from these sites.
Accordingly, in one of its method aspects, this invention is directed to a method for harvesting tissue and/or organs from a mammalian cadaver which method comprises:
(a) identifying the tissue and/or organ to be harvested from a mammalian cadaver;
(b) applying a sufficient amount of a composition comprising a polymerizable cyanoacrylate ester to the skin covering the tissue and/or organ defined in (a) above so as to cover this skin with the composition;
(c) polymerizing the cyanoacrylate ester so as to form a flexible, waterproof, adhesive polymer film which adheres to and overlays the skin area(s) where the composition was applied; and
(d) harvesting said tissue and/or organ by incision through the polymeric film and the underlying skin and subsequent removal of the tissue and/or organ.
Preferably, the polymerizable cyanoacrylate ester comprises an ester which, in monomeric form, is represented by formula I:
where R is selected from the group consisting of:
alkyl of 3 to 10 carbon atoms,
alkenyl of 2 to 10 carbon atoms,
cycloalkyl groups of from 5 to 8 carbon atoms,
phenyl,
2-ethoxyethyl,
3-methoxybutyl,
3-propoxypropyl,
and a substituent of the formula:
wherein each R′ is independently selected from the group consisting of:
hydrogen and methyl, and
R″ is selected from the group consisting of:
alkyl of from 1 to 6 carbon atoms,
alkenyl of from 2 to 6 carbon atoms,
alky
Burns Doane Swecker & Mathis L.L.P.
Flowers Park Ltd.
George Konata M.
Hartley Michael G.
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