US5643596A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Hemostatic patch
Assignee: CLARION FUND Inc
•
Filing: 1995-06-07
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Granted: 1997-07-01
•
Expires: 2015-06-07
Abstract
Abstract A fibrogen-free substrate having as a hemostatic agent on a surface thereof a mixture of a clot-promoting amount of thrombin and an amount of epsilon aminocaproic acid (EACA) effective to accelerate the rate of blood clotting induced by the thrombin is useful as a hemostatic patch which is safe, inexpensive and which rapidly controls bleeding from a wound. A patch which rapidly stanches the flow of blood from a lesion on a parenchymal organ by pressing it against the surface of the organ for 3-5 minutes, is produced by applying thrombin, EACA and CaCl 2 to a rigid sheet of biodegradable foam, such as an absorbable gelatin sponge, and compressing the dry sheet to produce a flexible sheet which conforms to the contour of the organ without the necessity of pre-moistening. The problem associated with thrombin-fibrinogen glues of adhesion of the wounded surface of the organ to adjacent tissue is avoided by applying the hemostatic agent to only the wound-contacting face of the sheet.
Inventors
- 👤 Thaddeus P. Pruss
- 👤 James A. Will
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 04:54
CPC Classifications
A; A61; A61L; A61L26/00; A61L26/0061; A61L26/009; A61F; A61F13/00; A61F13/02; A61F13/0203; A61L15/00; A61L15/16; A61L15/42; A61L15/44; A61L15/64; A61L24/00; A61L24/001; A61L24/0015; A61L24/0042; A61F2013/00089; A61F2013/00217; A61F2013/00221; A61F2013/00361; A61F2013/00365; A61F2013/00463; A61F2013/00472; A61L2300/00; A61L2300/40; A61L2300/418; A61L2300/432; A61L2300/434; A61L2400/00; A61L2400/04
Claims Analysis
Total Claims: 18
Claim 1
Independent Claim
102 words
A hemostatic patch suitable for rapidly and without pre-moistening arresting bleeding from a lesion on a parenchymal organ, in the form of a dry sterile storage stable fibrogen-free flexible sheet of a biodegradable matrix selected from the group consisting of absorbable gelatin, calcium alginate, calcium/sodium alginate, collagen and oxidized regenerated cellulose and containing a hemostatic agent on one face only thereof, which hemostatic agent comprises an amount of thrombin effective to promote accelerated hemostasis and an amount of epsilon aminocaproic acid effective to inhibit fibrinolysis and to accelerate the activation of the thrombin when the patch is applied to the bleeding lesion.
Claim 2
Dependent Claim
102 words
A hemostatic patch suitable for rapidly and without pre-moistening arresting bleeding from a lesion on a parenchymal organ, in the form of a dry sterile storage stable fibrogen-free flexible sheet of a biodegradable matrix selected from the group consisting of absorbable gelatin, calcium alginate, calcium/sodium alginate, collagen and oxidized regenerated cellulose and containing a hemostatic agent on one face only thereof, which hemostatic agent comprises an amount of thrombin effective to promote accelerated hemostasis and an amount of epsilon aminocaproic acid effective to inhibit fibrinolysis and to accelerate the activation of the thrombin when the patch is applied to the bleeding lesion.
Claim 3
Dependent Claim
14 words
A hemostatic patch according to claim 1, wherein the biodegradable matrix is a foam.
Claim 4
Dependent Claim
14 words
A hemostatic patch according to claim 1, wherein the biodegradable matrix is absorbable gelatin.
Claim 5
Dependent Claim
28 words
A hemostatic patch according to claim 1, wherein the patch contains one or more of a source of calcium ions, RGD peptide, RGDS peptide, protamine sulfate and buffer.
Claim 6
Dependent Claim
13 words
A hemostatic patch according to claim 1, wherein the thrombin is bovine thrombin.
Claim 7
Dependent Claim
29 words
A hemostatic patch according to claim 1, wherein the epsilon aminocaproic acid is present in an amount from about 10-100 mg/cm 2 of the wound-contacting surface of the matrix.
Claim 8
Dependent Claim
26 words
A hemostatic patch according to claim 1, wherein the thrombin is present in an amount between 1-4 IU/cm 2 of the wound-contacting surface of the matrix.
Claim 9
Dependent Claim
31 words
A hemostatic patch according to claim 1, wherein calcium ions are present in an amount equivalent to between 25-150 micrograms CaCl 2 /cm 2 of the wound-contacting surface of the matrix.
Claim 10
Dependent Claim
99 words
A hemostatic patch according to claim 1, wherein the biodegradable matrix is an absorbable gelatin foam; wherein the patch optionally contains one or more of RGD peptide, RGDS peptide, protamine sulfate and buffer; wherein the epsilon aminocaproic acid is present in an amount between 60-70 mg/cm 2 of the wound-contacting surface of the matrix; wherein the thrombin is present in an amount between 1-4 IU/cm 2 of the wound-contacting surface of the matrix; and wherein calcium ions are present in an amount equivalent to between 25-150 micrograms of CaCl 2 /cm 2 of the wound-contacting surface of the matrix.
Claim 11
Dependent Claim
11 words
A sterile package containing a hemostatic patch according to claim 1.
Claim 12
Dependent Claim
11 words
A sterile package containing a hemostatic patch according to claim 9.
Claim 13
Dependent Claim
22 words
A method for stanching bleeding from a wound, which comprises applying to the wounded surface a hemostatic patch according to claim 1.
Claim 14
Dependent Claim
22 words
A method for stanching bleeding from a wound, which comprises applying to the wounded surface a hemostatic patch according to claim 9.
Claim 15
Dependent Claim
28 words
A method for effecting hemostasis in a bleeding parenchymal organ, which comprises applying to the bleeding surface of the parenchymal organ a hemostatic patch according to claim 1.
Claim 16
Dependent Claim
28 words
A method for effecting hemostasis in a bleeding parenchymal organ, which comprises covering the bleeding surface of the parenchymal organ with a hemostatic patch according to claim 9.
Claim 17
Dependent Claim
45 words
A method according to claim 15, which comprises manually pressing the hemostatic agent-containing surface of the patch against the wounded surface of the parenchymal organ for a period of time until clotting has occurred at the interface between the hemostatic patch and the wounded surface.
Claim 18
Dependent Claim
16 words
A method according to claim 15, wherein the parenchymal organ is a liver, kidney or spleen.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2000-06-30 | 2000-12-30 | 2001-07-01 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2004-06-30 | 2004-12-30 | 2005-07-01 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2008-06-30 | 2008-12-30 | 2009-07-01 | $7700.00 | Window Closed / Lapsed |