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Fibrin glue without fibrinogen and biosealant compositions and methods

a technology of fibrinogen and fibrin glue, which is applied in the field of fibrin glue without fibrinogen, can solve the problems of clogging the endoscope, preventing the effective delivery of fibrin glue, and affecting the effect of endoscopy

Inactive Publication Date: 2001-08-23
WORTHAM LEON
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0025] The fibrin glue without fibrinogen of the instant invention provides several advantages. One important advantage is that it arrests blood flow immediately on contact with the tissue being treated and prevents unwanted, premature clot formation prior to the application to the tissue being treated. As a result, the fibrin glue may be utilized in endoscopic surgical procedures, in which the fibrin glue is applied through an endoscope to access the tissue being treated, such as an internal organ. Endoscopic use of the fibrin glues of the past proved unworkable as the premixed fibrinogen and thrombin composition would form a clot prior to arriving at the tissue being treated. This would clog the endoscope and prevent effective delivery of the fibrin glue. Also unworkable was the use of low concentrations of thrombin as the thrombin would be further diluted through the endoscope to a concentration that was inadequate to form proper clotting of the tissue being treated.

Problems solved by technology

However, the prior art fibrin glue compositions required the mixture of thrombin with exogenous fibrinogen to form an unwanted, premature fibrin clot, prior to the application of the fibrin glue to the tissue being treated.
Endoscopic use of the fibrin glues of the past proved unworkable as the premixed fibrinogen and thrombin composition would form a clot prior to arriving at the tissue being treated.
This would clog the endoscope and prevent effective delivery of the fibrin glue.
Also unworkable was the use of low concentrations of thrombin as the thrombin would be further diluted through the endoscope to a concentration that was inadequate to form proper clotting of the tissue being treated.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 2

[0059] Manufacture of Thromboplastin

[0060] Thromboplastin is isolated by the following procedure:

[0061] 1. Concentrate platelets by filtering off the plasma through a Buchner funnel.

[0062] 2. Wash platelets with 0.9% NaC I (suitable range 0.1%-2%).

[0063] 3. Resuspend platelets with cold 0.9% NaCl in two times volume.

[0064] 4. Place in a blender for ten minutes at high speed (avoid temperature rising above 37.degree. C.).

[0065] 5. Centrifuge at 5,000 rpm for ten minutes at 2-8.degree. C.

[0066] 6. Discard precipitate and retain supernatant.

example 3

[0067] Blending the Fibrin Glue

[0068] In order to manufacture the fibrin glue of the invention the following components are admixed.

[0069] 1. Add 1% by volume (range 0.0001-99.99%, preferred range 0.5-1.5%) of the thromboplastin from Example 2, step 6 to the thrombin concentrate from Example 1, step 15 (range 0.00001-100,000 U / ml, preferred range 1-100,000 U / ml).

[0070] 2. Add CaCl.sub.2 to the thrombin / thromboplastin solution to a concentration of 0.02 M (range 0.01-1M, preferred range 0.015-0.025 M).

[0071] 3. Blend with a pharmaceutically acceptable carrier if desired. Such carriers and blending techniques are well known in the art and need not be described herein.

[0072] It is recognized that prothrombin, thromboplastin, and Factors VII, IX and X, for use in the composition of the fibrin glue of the present invention can be obtained from other than a human source, such as from animals, or may be synthetically produced, such as with recombinant DNA techniques known by those skilled ...

example 4

[0073] Manufacture of Sealant

[0074] Another embodiment of the fibrin glue of the present invention comprises an improved sealant or "biosealant" with a greater tensile strength than fibrinogen used alone as a sealant. The improved biosealant of the present invention is a two-component system that provides a 200 g / cm.sup.2 tensile strength in the first minute after application to the site being treated, and 650 g / cm.sup.2 two hours after application. This is a great advantage over a tensile strength of 50 g / cm.sup.2 and 450 g / cm.sup.2, respectively, using fibrinogen.

[0075] The first component of the improved sealant comprises 375 ml of 1 g gelatin / 500 ml H.sub.2O, 125 ml of 1M resorcinol, and 500 ml of H.sub.2O (range 0.06-10 g gelatin per 500 ml and 0.001-5 M resorcinol, preferred range about 0.2-0.5 g gelatin / 500 ml and about 0.05-2 M resorcinol).

[0076] The second component of the improved sealant (for a volume of 250 ml for example), comprises 225 ml of 37% (1.76 M glyoxal and 25 ...

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Abstract

The invention is a fibrin glue that avoids the use of fibrinogen and thus eliminates the need for premixing and premature clot formation. The fibrin glue of the invention comprises thrombin, thromboplastin and calcium and may have clotting Factors, VII, IX and X, and the like. The invention also comprises a biosealant for use with the fibrin glue without fibrinogen or for use alone. The biosealant is a two component mixture of gelatin / resorcinol and glyoxal / glutaraldehyde / 4-(p-maleimidophenyl) butyric acid. The two components are mixed on use.

Description

[0001] This is a divisional of application Ser. No. 09 / 159,736, filed Sep. 24, 1998 which claims priority to application Ser. No. 60 / 064,864, filed Sep. 26, 1997.[0002] 1. Related Application[0003] 2. Field of the Invention[0004] The present invention describes various bioadhesive sealants. One is a hemostatic agent commonly known as a "fibrin glue" and is a novel fibrin glue that lacks fibrinogen. There is also provided a biosealant composition. Methods of use and manufacture of the fibrin glue and biosealant are also provided. The fibrin glue and biosealant compositions and methods of the present invention are suitable for arresting blood flow, maintaining hemostasis, and for accelerating and ameliorating the healing process after various types of surgical and nonsurgical procedures or wound healing in mammals, including humans.[0005] 3. Description of the Related Art[0006] The use of fibrin glue has been explored in various surgical disciplines as reported by Lerner, R. & Binur, ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61L24/04A61L24/10
CPCA61L24/043A61L24/104A61L24/106A61L24/108Y10S514/822Y10S514/802
Inventor WORTHAM, LEON
Owner WORTHAM LEON
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