# US 5,702,715 A · Reinforced biological sealants

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- Number: US 5,702,715 A
- Document ID: US5702715A
- Status: Granted
- Kind: A
- Application number: 08/549,365
- Filed: 1995-10-27
- Granted: 1997-12-30
- Earliest claimed: 1995-10-27
- Assignees: Drying Technology
- Inventors: Victor V. Nikolaychik; Brent A. Burdick; Leonid V. Nikolaychik
- Web page: https://patentgrep.com/patent/US5702715A

## CPC

- A61L 24/106: {Fibrin; Fibrinogen}
- A61L 24/0073: {with a macromolecular matrix}
- A61L: METHODS 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 (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A reinforced biological sealant is disclosed. The sealant includes a fibrinogen composition adapted to be applied to a wound, and a solid thrombin composition layered on the fibrinogen film. At least one of the fibrinogen or thrombin compositions comprises a reinforcement filler. Means are provided for activating formation of a fibrin mesh from the fibrinogen and thrombin compositions, thereby effecting hermetization and hemostasis of the wound.

## Claims

### Claim 1

A reinforced, prefabricated biological sealant, the sealant comprising:
a) a fibrinogen composition adapted to be applied to a treatment condition, and
b) a thrombin composition layered on the fibrinogen composition,
wherein at least one of the fibrinogen or thrombin composition comprises a reinforcement filler so that the sealant comprises a reinforcement filler, wherein the sealant has a critical pressure of at least 150 mm Hg at two minutes, and wherein the sealant is a solid film.

### Claim 2 (depends on 1)

The sealant of claim 1 wherein the fibrinogen composition is a solid.

### Claim 3 (depends on 2)

The sealant of claim 2 wherein the fibrinogen composition is a film.

### Claim 4 (depends on 1)

The sealant of claim 1 wherein the thrombin composition is a solid.

### Claim 5 (depends on 4)

The sealant of claim 4 wherein the thrombin composition is a film.

### Claim 6 (depends on 1)

The sealant of claim 1 wherein the thrombin composition is a solution.

### Claim 7 (depends on 1)

The sealant of claim 1 wherein the thrombin composition comprises a reinforcement filler.

### Claim 8 (depends on 1)

The sealant of claim 1 wherein the fibrinogen composition comprises a reinforcement filler.

### Claim 9 (depends on 1)

The sealant of claim 1 wherein the filler is selected from the group consisting of polyethylene glycol, myo-inositol, polyvinylpyrrolidone, bovine serum albumin, dextran, mannitol, sodium chlorate, and FICOLL.

### Claim 10 (depends on 1)

The sealant of claim 1 wherein a colored indicator substance is added to at least one of the compositions.

### Claim 11 (depends on 10)

The sealant of claim 10 wherein the colored substance indicates the formation of the mesh by a color change.

### Claim 12 (depends on 1)

The sealant of claim 1, wherein the sealant has a critical pressure of at least 200 mm Hg at two minutes.

### Claim 13 (depends on 1)

The sealant of claim 1 wherein the sealant has a critical pressure of at least 320 mm Hg at two minutes.

### Claim 14

A reinforced, prefabricated biological sealant, the sealant comprising:
a) a fibrinogen composition adapted to be applied to a treatment condition, and
b) a thrombin composition layered on the fibrinogen composition,
wherein at least one of the fibrinogen or thrombin composition comprises a reinforcement filler so that the sealant comprises a reinforcement filler, wherein the sealant has a critical pressure of at least 150 mm Hg at two minutes, wherein the sealant is a solid film, and wherein the fibrinogen and thrombin compositions are dried for 5 to 24 hours at temperatures in the range of 10.degree. C. to 50.degree. C., at a pressure in the range of 25 Torr to 300 Torr.

### Claim 15 (depends on 14)

The sealant of claim 14, wherein the sealant is dried at about 15.degree. C. for about 6 hours at about 50 Torr.