US2558395A - Undenatured gelatin hemostatic sponge containing thrombin - Google Patents

Undenatured gelatin hemostatic sponge containing thrombin Download PDF

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US2558395A
US2558395A US1736648A US2558395A US 2558395 A US2558395 A US 2558395A US 1736648 A US1736648 A US 1736648A US 2558395 A US2558395 A US 2558395A
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Prior art keywords
thrombin
solution
gelatin
water
tampons
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Andre Studer
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F Hoffmann-La Roche AG
Hoffmann-La Roche Inc
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F Hoffmann-La Roche AG
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/425Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/64Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the body
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G
    • C08J9/00Working-up of macromolecular substances to porous or cellular articles or materials; After-treatment thereof
    • C08J9/28Working-up of macromolecular substances to porous or cellular articles or materials; After-treatment thereof by elimination of a liquid phase from a macromolecular composition or article, e.g. drying of coagulum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/04Materials for stopping bleeding
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G
    • C08J2389/00Characterised by the use of proteins; Derivatives thereof
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S514/00Drug, bio-affecting and body treating compositions
    • Y10S514/802Fibrinopeptides, blood-coagulation factors or derivatives

Description

Patented June 26, 1951 TUNITED' STATES PATENT OFFICE Andr Studerl...B.a seL Switzerland, assignor to Hoiimann-La Roche Inc., Nutley, N. J acorporation of New Jersey No Drawing. Application March 26, 1948, Serial No. 17,366: In SWitzerlandJune 3, 194.7

The present invention relates to a process for the manufacture of hemostatic tampons and bandages.

In surgery hemostatic tampons and bandages consisting of fibrinand"cellulose-derivative sponges which contain a, thrombin solution are used. These tampons and bandages are prepared for use by dipping them into a thrombin solution immediately priorto application. This mode of use requires the sponges to consist of a material insoluble in water, because otherwise they would collapse during the contact with the aqueous thrombin solution. 'Such sponges have the disadvantage of being resorbed much more slowly by the organism than water soluble sub stances. r

In order to avoid this disadvantage a soluble gelatine gel has been used in place of the said sponges. This gel is immersed in a thrombin solution immediately prior to application. However, it is difiicult and takes a considerable amount of time to obtain the complete impregnation of such gels by the thrombin solution. Furthermore, such impregnated tampons cannot be stored because the thrombin is unstable in the presence of water and its activity quickly diminishes. Again it has been found that thrombin brings about a diminution of the jellifying quality of the gelatin.

It has now been found, according to the present invention, that hemostatic tampon and bandages may be prepared from undenatured water soluble gelatin by adding thrombin to an aqueous gelatin solution, transforming the solution obtained into foam and drying the foam obtained in vacuo at a low temperature. The form of the thrombonic gelatin sponge may be adapted to the requirements of the intended use. The present process yields hemostatic tampons and bandages consisting of an easily soluble mass of gelatin and thrombin and which is of a cotton-wool like appearance. These tampons and bandages need not be dipped into a thrombin solution but may be placed on any wound without prior treatment. The new tampons and bandages quickly cause hemostasis; the blood flowing from the Wound is absorbed into the sponge, thereby dissolving the gelatin component; the thrombin which is thus released immediately causes the transformation of fibrinogen into fibrin. A fibrin film is thus formed over the wound, whereby the latter is closed and the flow of the blood is stopped. The film clings tightly to the surface of the wound, in many cases rendering the use of bandages or like means of protection unneces- The efiiciency of the tampons manufactured in accordance with the present invention may be demonstrated in vitro by the following experiment: .In a test tube (about 1 cm. internal diameterl a few tampons are loosely stamped to form a column about 5 cm. high. 5 com. of plasma of 37 C. are poured thereon. The plasma issucked into the sponge-like material and coagulates so quickly that the test tube may be turned upside down directly after filling in the plasma without any of the latter running out.

If so desired antiseptic agents may be added to the gelatin-thrombin product without influencing the activity of the tampons and bandages. Thymol, a mixture of p-hydroxybenzoic-acidmethyl and propylester, or sulfamides, such as 5-sulfanilamido-3,l-dimethyl-isoxazole, are :antiseptics which may be so used. The addition of substances accelerating cicatrization, such as panthenol, may also be found to be useful. Panthenol is the generic name for 'y-dihydroxy- 3,5 dimethyl butyric acid (3' hydroxypropyl) -amide.

The gelatin has a protective and stabilizing effect on the thrombin with which it is impregnated. It has been found, for instance, that the activity of an aqueous thrombin solution containing 5 per cent. gelatin falls away more slowly than in the case of such a solution containing no gelatin. The following table in which Th. U. stands for thrombin units (1 llh. U. being the amount of thrombin which causes 1 ccm. of plasma of bovine to coagulate within 30 seconds at a temperature of 37 0.), illustrates this fact:

5 grams of gelatin in sheets are added to 100 com. of distilled water. The mixture is heated to C. and filtered while still warm through a filter which retains bacteria. The filtrate is adjusted to a pH of 6.6. 10 com. of a thrombin solution containing 10,000 units per com. (vide supra) are added to 50 com. of the filtrate which ha been cooled down to a temperature of 20 C. (This thrombin solution may be prepared from a,

thrombin preparation showing on titration a content of 100 Th. U./mg.) The slightly turbid solution is passed through, a filter which retains bacteria. The clear solution is transformed into a voluminous foam by blowing in sterile air through a" glass plate. The froth is spread out over a sheet, frozen and dehydrated in high vacuo at low temperature.'

Example 2 70 mg. of thymol are dissolved in 100 com. warm distilled water. grams of gelatin are added to the solution and the mixture is heated to 80 C. Further working as describedin Example 1.

Example 3 20 mg. of p-hydroxybenzoylmethylester and 80 4 freeze-dried foam of an aqueous solution containing undenatured water-soluble gelatin and thrombin.

2. A preformed hemostatic sponge made by drying, at low temperature and under reduced pressure, a foam of an aqueous solution containing undenatured water-soluble gelatin and thrombin.

mg. of p-hydroxybenzoylpropylester are dissolved in 100 ccm. of distilled water. 5 mg. of gelatin are added and the mixture is heated to 80 C. Further working as described in Example 1.

Example 4 5 grams of gelatin in 90 com. distilled water are heated to 80 C. 2 grams of finely pulverised5- sulfanilamido-3,4-dimethylisoxazole are suspended in the warm solution. The solution is set to a pH of 6.6 by adding 5 to 10 com. of normal sodium hydroxide. The sulfanilamide then dissolves. The mixture is heated to 80 C. and Worked further in accordance with Example 1.

Example 5 0.2 gram of panthenol is dissolved in 100 com. of distilled water. 5 grams of gelatin are added. The mixture is heated to 80 C. and worked further in accordance with Example 1.

I claim:

1. As a ready-to-use hemostatic sponge, a

3. A preformed hemostatic sponge made by freezing a foam of an aqueous solution containing undenatured water-soluble gelatin and thrombin, and drying the frozen foam in vacuo at a low temperatur r ANDRE STUDER.

REFERENCES CITED The following references are of record in the file of this patent:

UNITED STATES PATENTS Number .Name Date 2,166,074 Reichel July 11, 1939 2,398,077 Smith Apr. 9, 1946 FOREIGN PATENTS Number Country 7 Date 474,093 Germany Mar. 26, 1929 OTHER REFERENCES Lesser, Drug and Cosmetic Industry, March,

' 1947, page 329.

Bing, Acta Pharmacol, 1947, vol. 3, page 366.

American Druggist, October, 1947, pages 9 96 and 16 8.

Correll et al., Proc. Soc. Exper. Biol.- and Medicine, 58, 233-5, March, 1945.

Bering, J. Clinical Investigation No. 4, 1944, pages 586-590.

Claims (1)

1. AS A READY-TO-USE HEMOSTATIC SPONGE, A FREEZE-DRIED FOAM OF AN AQUEOUS SOLUTION CONTAINING UNDENATURED WATER-SOLUBLE GELATIN AND THROMBIN.
US2558395A 1947-06-03 1948-03-26 Undenatured gelatin hemostatic sponge containing thrombin Expired - Lifetime US2558395A (en)

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US2642375A (en) * 1951-08-21 1953-06-16 Ethicon Suture Lab Inc Hemostatic compositions
US2712672A (en) * 1952-01-28 1955-07-12 Calcagno Luigi Process for preparing proteic sponges
US2718487A (en) * 1950-12-18 1955-09-20 Hoechst Ag Hemostatics containing reaction products of thrombin and acridines and process of preparing same
US3234091A (en) * 1955-07-08 1966-02-08 Ciba Geigy Corp Shaped medicaments and process for their manufacture
US4006220A (en) * 1975-06-04 1977-02-01 Gottlieb Sheldon K Compositions and methods useful for repairing depressed cutaneous scars
US4292972A (en) * 1980-07-09 1981-10-06 E. R. Squibb & Sons, Inc. Lyophilized hydrocolloio foam
US4341207A (en) * 1979-09-07 1982-07-27 Kingsdown Medical Consultants Limited Wound dressing
US4538603A (en) * 1982-04-22 1985-09-03 E. R. Squibb & Sons, Inc. Dressings, granules, and their use in treating wounds
US5039414A (en) * 1989-08-01 1991-08-13 Mueller Marc B Process for separating and/or recovering hydrocarbon oils from water using biodegradable absorbent sponges
US5149540A (en) * 1990-03-01 1992-09-22 Mochida Pharmaceutical Co., Ltd. Thrombin composition for oral administration
US6071301A (en) * 1998-05-01 2000-06-06 Sub Q., Inc. Device and method for facilitating hemostasis of a biopsy tract
US6162192A (en) * 1998-05-01 2000-12-19 Sub Q, Inc. System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge
US6183497B1 (en) 1998-05-01 2001-02-06 Sub-Q, Inc. Absorbable sponge with contrasting agent
US6200328B1 (en) 1998-05-01 2001-03-13 Sub Q, Incorporated Device and method for facilitating hemostasis of a biopsy tract
US6261679B1 (en) 1998-05-22 2001-07-17 Kimberly-Clark Worldwide, Inc. Fibrous absorbent material and methods of making the same
US6315753B1 (en) 1998-05-01 2001-11-13 Sub-Q, Inc. System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge
US20020156495A1 (en) * 1995-09-15 2002-10-24 Rodney Brenneman Apparatus and method for percutaneous sealing of blood vessel punctures
US20020193448A1 (en) * 1996-08-27 2002-12-19 Wallace Donald G. Fragmented polymeric compositions and methods for their use
US20020190226A1 (en) * 2001-03-12 2002-12-19 Mark Ashby Methods for sterilizing cross-linked gelatin compositions
US6540735B1 (en) 2000-05-12 2003-04-01 Sub-Q, Inc. System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge
US20030064109A1 (en) * 2001-07-17 2003-04-03 Zhen Qian Dry hemostatic compositions and methods for their preparation
US6544236B1 (en) 1999-02-10 2003-04-08 Sub-Q, Incorporated Device, system and method for improving delivery of hemostatic material
US20030155679A1 (en) * 2001-12-31 2003-08-21 Reeves William G. Method of making regenerated carbohydrate foam compositions
US6610026B2 (en) 1998-05-01 2003-08-26 Sub-Q, Inc. Method of hydrating a sponge material for delivery to a body
US20040019330A1 (en) * 2001-11-08 2004-01-29 Sub-Q, Inc., A California Corporation Sheath based blood vessel puncture locator and depth indicator
US20040102730A1 (en) * 2002-10-22 2004-05-27 Davis Thomas P. System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge
US20040158287A1 (en) * 2000-07-14 2004-08-12 Cragg Andrew H. Sheath-mounted arterial plug delivery device
US20040176723A1 (en) * 2001-11-08 2004-09-09 Sing Eduardo Chi Pledget-handling system and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure
US6846320B2 (en) 1998-05-01 2005-01-25 Sub-Q, Inc. Device and method for facilitating hemostasis of a biopsy tract
US20050033360A1 (en) * 2001-11-08 2005-02-10 Sing Eduardo Chi Pledget-handling system and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure
US6863680B2 (en) 2001-11-08 2005-03-08 Sub-Q, Inc. System and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure
EP1572004A2 (en) * 2002-11-04 2005-09-14 Sub Q, Inc. Apparatus and method for inhibiting blood loss
US6984219B2 (en) 1999-09-23 2006-01-10 Mark Ashby Depth and puncture control for blood vessel hemostasis system
US7008440B2 (en) 2001-11-08 2006-03-07 Sub-Q, Inc. System and method for delivering hemostasis promoting material to a blood vessel puncture site by fluid pressure
US7029489B1 (en) 2001-05-18 2006-04-18 Sub-Q, Inc. System and method for delivering hemostasis promoting material to a blood vessel puncture site
US7037322B1 (en) 2001-11-08 2006-05-02 Sub-Q, Inc. System and method for delivering hemostasis promoting material to a blood vessel puncture with a staging tube
US20060115805A1 (en) * 2002-12-11 2006-06-01 Hansen John E Gelatine-based materials as swabs
US20060167561A1 (en) * 2003-06-05 2006-07-27 Johann Odar Methods for repairing and regenerating human dura mater
US20070009578A1 (en) * 2004-07-09 2007-01-11 Lene Moller Haemostatic composition comprising hyaluronic acid
US7201725B1 (en) 2000-09-25 2007-04-10 Sub-Q, Inc. Device and method for determining a depth of an incision
US20070160543A1 (en) * 2004-01-30 2007-07-12 Lene Moller Haemostatic sprays and compositions
US20080076722A1 (en) * 2006-09-27 2008-03-27 Hemostasis, Llc Hemostatic Agent and Method
US20080085316A1 (en) * 1996-08-27 2008-04-10 Baxter Healthcare Corporation Dry hemostatic compositions and methods for their preparation
US20080187591A1 (en) * 2006-08-02 2008-08-07 Baxter International, Inc. Rapidly acting dry sealant and methods for use and manufacture
US20090226391A1 (en) * 2008-03-04 2009-09-10 Hemostasis, Llc Hemostatic Sponge and Method of Manufacture
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US20100028309A1 (en) * 2006-05-31 2010-02-04 Baxter International Inc. Method for directed cell in-growth and controlled tissue regeneration in spinal surgery
US7695492B1 (en) 1999-09-23 2010-04-13 Boston Scientific Scimed, Inc. Enhanced bleed back system
US20100183582A1 (en) * 2003-08-07 2010-07-22 Ethicon, Inc. Hemostatic compositions containing sterile thrombin
US20100292717A1 (en) * 2009-05-18 2010-11-18 Baxter International Inc. Method for the improvement of mesh implant biocompatibility
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US20110014290A1 (en) * 1995-09-15 2011-01-20 Boston Scientific Scimed, Inc. System and method for facilitating hemostasis with an absorbable sponge
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Cited By (141)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2718487A (en) * 1950-12-18 1955-09-20 Hoechst Ag Hemostatics containing reaction products of thrombin and acridines and process of preparing same
US2642375A (en) * 1951-08-21 1953-06-16 Ethicon Suture Lab Inc Hemostatic compositions
US2712672A (en) * 1952-01-28 1955-07-12 Calcagno Luigi Process for preparing proteic sponges
US3234091A (en) * 1955-07-08 1966-02-08 Ciba Geigy Corp Shaped medicaments and process for their manufacture
US4006220A (en) * 1975-06-04 1977-02-01 Gottlieb Sheldon K Compositions and methods useful for repairing depressed cutaneous scars
US4341207A (en) * 1979-09-07 1982-07-27 Kingsdown Medical Consultants Limited Wound dressing
US4292972A (en) * 1980-07-09 1981-10-06 E. R. Squibb & Sons, Inc. Lyophilized hydrocolloio foam
EP0044624A1 (en) * 1980-07-09 1982-01-27 E.R. Squibb & Sons, Inc. Lyophilized hydrocolloid foam
US4538603A (en) * 1982-04-22 1985-09-03 E. R. Squibb & Sons, Inc. Dressings, granules, and their use in treating wounds
US5039414A (en) * 1989-08-01 1991-08-13 Mueller Marc B Process for separating and/or recovering hydrocarbon oils from water using biodegradable absorbent sponges
US5149540A (en) * 1990-03-01 1992-09-22 Mochida Pharmaceutical Co., Ltd. Thrombin composition for oral administration
US7175646B2 (en) 1995-09-15 2007-02-13 Boston Scientific Scimed, Inc. Apparatus and method for percutaneous sealing of blood vessel punctures
US20110014290A1 (en) * 1995-09-15 2011-01-20 Boston Scientific Scimed, Inc. System and method for facilitating hemostasis with an absorbable sponge
US20020156495A1 (en) * 1995-09-15 2002-10-24 Rodney Brenneman Apparatus and method for percutaneous sealing of blood vessel punctures
US7871637B2 (en) 1996-08-27 2011-01-18 Baxter International Inc. Dry hemostatic compositions and methods for their preparation
US8603511B2 (en) 1996-08-27 2013-12-10 Baxter International, Inc. Fragmented polymeric compositions and methods for their use
US20020193448A1 (en) * 1996-08-27 2002-12-19 Wallace Donald G. Fragmented polymeric compositions and methods for their use
US8303981B2 (en) 1996-08-27 2012-11-06 Baxter International Inc. Fragmented polymeric compositions and methods for their use
US8512729B2 (en) 1996-08-27 2013-08-20 Baxter International Inc. Fragmented polymeric compositions and methods for their use
US8357378B2 (en) 1996-08-27 2013-01-22 Baxter International Inc. Fragmented polymeric compositions and methods for their use
US20080085316A1 (en) * 1996-08-27 2008-04-10 Baxter Healthcare Corporation Dry hemostatic compositions and methods for their preparation
US6315753B1 (en) 1998-05-01 2001-11-13 Sub-Q, Inc. System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge
US8050741B2 (en) 1998-05-01 2011-11-01 Boston Scientific Scimed, Inc. Device and method for facilitating hemostasis of a biopsy tract
US6527734B2 (en) 1998-05-01 2003-03-04 Sub-Q, Inc. System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge
US6447534B2 (en) 1998-05-01 2002-09-10 Sub-Q, Inc. Device and method for facilitating hemostasis of a biopsy tract
US6440153B2 (en) 1998-05-01 2002-08-27 Sub-Q, Inc. Device and method for facilitating hemostasis of a biopsy tract
US20100029908A1 (en) * 1998-05-01 2010-02-04 Boston Scientific Scimed, Inc. Absorbable sponge with contrasting agent
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DK73956C (en) 1952-03-31 grant
ES183694A1 (en) 1948-07-04 application
ES183694A3 (en) application

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