Surgery: splint – brace – or bandage – Bandage structure – Skin laceration or wound cover
Reexamination Certificate
2002-03-22
2004-07-13
Lewis, Kim M. (Department: 3761)
Surgery: splint, brace, or bandage
Bandage structure
Skin laceration or wound cover
C602S042000, C602S043000
Reexamination Certificate
active
06762336
ABSTRACT:
I. FIELD OF THE INVENTION
The present invention relates to a hemostatic sandwich bandage which comprises a plurality of layers that contain resorbable materials and/or coagulation proteins. The inventive hemostatic sandwich bandage is useful for the treatment of wounded tissue.
II. BACKGROUND OF THE INVENTION
The control of hemorrhage (bleeding) is a critical step in first aid and field trauma care. Unfortunately, the materials and methods available to stop bleeding in prehospital care (gauze dressings, direct pressure, and tourniquets) have not changed greatly in the past 2000 years. L. Zimmerman et al.,
Great Ideas in the History of Surgery
(San Francisco, Calif.: Norman Publishing; 1993), 31. Even in good hands they are not uniformly effective, and the occurrence of excessive bleeding or fatal hemorrhage from an accessible site is not uncommon. J. M. Rocko et al.,
J. Trauma
22:635 (1982).
Mortality data from Vietnam indicates that 10% of combat deaths were due to uncontrolled extremity hemorrhage.
SAS/STAT Users Guide
, 4th ed. (Cary, N.C.: SAS Institute Inc; 1990). Up to one third of the deaths from exsanguination during the Vietnam War could have been prevented by the use of effective field hemorrhage control methods.
SAS/STAT Users Guide
, 4th ed. (Cary, N.C.: SAS Institute Inc; 1990).
Although civilian trauma mortality statistics do not provide exact numbers for prehospital deaths from extremity hemorrhage, case and anecdotal reports indicate similar occurrences. J. M. Rocko et al.,
J. Trauma
22:635 (1982). These data suggest that a substantial increase in survival can be effected by the prehospital use of a simple and effective method of hemorrhage control.
Liquid fibrin sealants have been used for years as an operating room adjunct for hemorrhage control. J. L. Garza et al.,
J. Trauma
30:512-513 (1990); H. B. Kram et al.,
J. Trauma
30:97-101(1990); M. G. Ochsner et al.,
J. Trauma
30:884-887 (1990); T. L. Matthew et al.,
Ann. Thorac. Surg
. 50:40-44 (1990); H. Jakob et al.,
J. Vasc. Surg
., 1:171-180 (1984). The first mention of tissue glue used for hemostasis dates back to 1909
. Current Trends in Surgical Tissue Adhesives: Proceedings of the First International Symposium on Surgical Adhesives
, M. J. MacPhee et al., eds. (Lancaster, Pa.: Technomic Publishing Co; 1995). The widespread use of fibrinogen and thrombin was common in the last year of World War II, but was abandoned because of the transmission of hepatitis. D. B. Kendrick,
Blood Program in WW II
(Washington. D.C.: Office of the Surgeon General, Department of Army; 1989). 363-368.
Currently, single donor fibrin sealants are widely used clinically, not only for hemorrhage control but in various surgical situations. W. D. Spotnitz,
Thromb. Haemost
. 74:482-485 (1995); R. Lerner et al.,
J. Surg. Res
. 48:165-181 (1990). Even more extensive use is limited by the strict requirements for temperature control, availability of thawed blood components, and the need for mixing of components. Additional problems with the standard fibrin sealants stem from the transfusion risk of human cryoprecipitate (E. M. Soland et al.,
JAMA
274:1368-1373 (1995)), the low and variable amounts of fibrinogen in the cryoprecipitate (10-30 mg) (P. M. Ness et al.,
JAMA
241:1690-1691 (1979)), hypotensive responses to bovine thrombin (R. Berguer et al.,
J. Trauma
31:408-411 (1991)) and antibody responses to bovine thrombin (S. J. Rapaport et al.,
Am. J. Clin. Pathol
. 97:84-91 (1992)).
The American Red Cross and others have developed plasma protein purification methods that seem to eliminate the hepatitis risk. R. F. Reiss et al.,
Trans. Med. Rev
. 10:85-92 (1996). These products are presently being considered for approval by the Food and Drug Administration.
A dry fibrinogen-thrombin dressing (TACHOCOMB™, Hafslund Nycomed Pharma, Linz, Austria) is also available for operating room use in many European countries. U. Schiele et al.,
Clin. Materials
9:169-177 (1992). Present formulations of this dressing use bovine thrombin. While this fibrinogen-thrombin dressing requires no premixing and is easy to use, its utility for field applications is limited by a requirement for storage at 4° C. and the necessity for prewetting with saline solution prior to application to the wound.
III. SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a hemostatic sandwich bandage that can be used for wound healing. Other objects, features and advantages of the present invention will be set forth in the detailed description of preferred embodiments that follows, and in part will be apparent from the description or may be learned by practice of the invention. These objects and advantages of the invention will be realized and attained by the compositions and methods particularly pointed out in the written description and claims hereof.
In accordance with these and other objects, a first embodiment of the present invention is directed to a hemostatic sandwich bandage for treating wounded tissue in a patient which comprises: (i) a first fibrinogen layer; (ii) a thrombin layer adjacent to the first fibrinogen layer; and (iii) a second fibrinogen layer adjacent to the thrombin layer.
A second embodiment of the present invention is directed to a hemostatic sandwich bandage for treating wounded tissue in a patient which comprises: (i) a resorbable material layer; (ii) a first fibrinogen layer adjacent to the resorbable material layer; (iii) a thrombin layer adjacent to the first fibrinogen layer; and (iv) a second fibrinogen layer adjacent to the thrombin layer.
A third embodiment of the present invention is directed to a hemostatic sandwich bandage or treating wounded tissue in a patient which comprises: (i) a first fibrinogen layer; (ii) a resorbable material layer adjacent to the first fibrinogen layer; (iii) a thrombin layer adjacent to the resorbable material layer; and (iv) a second fibrinogen layer adjacent to the thrombin layer.
A fourth embodiment of the present invention is directed to a hemostatic sandwich bandage for treating wounded in a patient which comprises: (i) a resorbable material layer; and (ii) a thrombin layer adjacent to the resorbable material layer. The resorbable material layer may also optionally contain fibrinogen.
A fifth embodiment of the present invention is directed to a hemostatic sandwich bandage for treating wounded in a patient which comprises: (i) a first resorbable material layer; (ii) a second resorbable material layer adjacent to the first resorbable material layer; and (iii) a thrombin layer adjacent to the second resorbable material layer. The resorbable material layers may also optionally contain fibrinogen.
Each layer of the inventive hemostatic bandages may also optionally contain one or more suitable fillers, binding agents and/or solubilizing agents. In addition, each of the inventive hemostatic bandages may also optionally further comprise a release layer which contains a release agent and/or a backing material.
A sixth embodiment of the present invention is directed to methods for treating wounded tissue in a patient, which comprises applying any of the inventive hemostatic sandwich bandages to the wounded tissue.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the invention as claimed.
IV. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
A. Definitions
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which this invention belongs. All patents and publications mentioned herein are incorporated by reference.
“Patient” as used herein refers to human or animal individuals in need of medical care and/or treatment.
“Wound” as used herein refers to any damage to any tissue of a patient that results in the loss of brood from the circulatory system. The tissue may be an internal tissue, such as an organ or blood vessel, or a
Bayer Valdislav
Beall Dawson
Drohan William H.
Friedman Stanley A.
MacPhee Martin J.
Lewis Kim M.
Sterne Kessler Goldstein & Fox P.L.L.C.
The American National Red Cross
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