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Rapidly acting dry sealant and methods for use and manufacture

a technology of dry sealant and rapid action, applied in the direction of prosthesis, drug composition, peptide, etc., can solve the problems of less than optimal setting time for these materials, currently available materials may exhibit swelling properties, etc., and achieve the effect of slowing down the reaction tim

Inactive Publication Date: 2012-08-16
BAXTER INT INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides compositions for in vivo applications that can stop bleeding or contain fluid in a vertebrate. The compositions include a first cross-linkable component, a second cross-linkable component that cross-links with the first component, and a hydrogel-forming component that can be hydrated to fill interstices. The compositions have minimal swelling properties and can be used as tissue sealants for hemostatic and wound-healing applications. The first cross-linkable component can have multiple nucleophilic groups and the second cross-linkable component can have multiple electrophilic groups. The compositions can also include a polysaccharide or protein. The hydrogel-forming component can be a glycosaminoglycan or collagen. The compositions can be applied to a vertebrate to facilitate fluid containment.

Problems solved by technology

Yet in many cases the setting time for these materials can be less than optimal, whereas for surgical and other medical applications, a rapidly acting material is often preferred.
In other cases, currently available materials may exhibit swelling properties that are undesirable for certain surgical applications.

Method used

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  • Rapidly acting dry sealant and methods for use and manufacture
  • Rapidly acting dry sealant and methods for use and manufacture
  • Rapidly acting dry sealant and methods for use and manufacture

Examples

Experimental program
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Effect test

example 1

First and Second Component Compositions for Use in Sealant Matrix: Preparation of Crosslinked Multi-Amino PEG Compositions

[0314]The following stock solutions of various di-amino PEGs were prepared: Ten (10) grams of Jeffamine ED-2001 (obtained from Texaco Chemical Company, Houston, Tex.) was dissolved in 9 ml of water. Ten (10) grams of Jeffamine ED-4000 (also obtained from Texaco Chemical Company) was dissolved in 9 ml of water. 0.1 grams of di-amino PEG (3400 MW, obtained from Shearwater Polymers, Huntsville, Ala.) was dissolved in 300 μl of water. Each of the three di-amino PEG solutions prepared above was mixed with aqueous solutions of trifunctionally activated SC-PEG (TSC-PEG, 5000 MW, also obtained from Shearwater Polymers) as set forth in Table 1, below.

TABLE 1Preparation of Crosslinked Polymer CompositionsDi-amino PEGTSC-PEG + Aqueous Solvent50 μl 0 mg + 50 μl water50 μl10 mg + 50 μl PBS50 μl10 mg + 100 μl PBS250 μl 50 mg + 500 μl PBS

[0315]The solutions of di-amino PEG and ...

example 2

First and Second Component Compositions for Use in Sealant Matrix: Preparation of Crosslinked Poly(Lysine) Compositions

[0316]Ten (10) milligrams of poly-L-lysine hydrobromide (8,000 MW, obtained from Peninsula Laboratories, Belmont, Calif.) in 0.1 ml phosphate buffer (0.2M, pH=6.6) was mixed with 10 mg of tetrafunctionally activated SE-PEG (10,000 MW, obtained from Shearwater Polymers, Huntsville, Ala.) in 0.1 ml PBS. The composition formed a soft gel almost immediately.

example 3

First and Second Component Compositions for Use in Sealant Matrix: Effect of pH on Gel Formation of Tetra-Amino PEG / Tetra SE-PEG Formulations

[0317]Gels comprising various concentrations of tetra-amino PEG and tetra SE-PEG at pH 6, 7, and 8 were prepared in petri dishes. Following mixing of the tetra-amino PEG and tetra SE-PEG, the dishes were tilted repeatedly; the gelation time was considered to be the point at which the formulation ceased to flow. The effect of pH on gelation time of the various tetra-amino PEG / tetra SE-PEG formulations at room temperature is shown in Table 2, below.

TABLE 2Effect of pH on Gel Formation of Tetra-amino PEG / TetraSE-PEG FormulationsTetra-amino PEGTetra SE-PEGConc. (mg / ml)Conc. (mg / ml)pHGelation Time20206>90.0min2020720.0min202081.4min5050624.0min505073.5min5050810.0sec10010069.0min100100747.0sec100100810.0sec20020062.0min20020079.0sec20020085.0sec

[0318]The time required for gel formation decreased with increasing pH and increasing tetra-amino PEG and ...

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Abstract

Compositions, methods, and kits are provided for sealing applications. Compositions are prepared by combining a first cross-linkable component with a second cross-linkable component to form a porous matrix having interstices, and combining the porous matrix with a hydrogel-forming component to fill at least some of the interstices. The compositions exhibit minimal swelling properties.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 11 / 832,380 filed Aug. 1, 2007, which claims the benefit of priority from U.S. Patent Application No. 60 / 821,190 filed Aug. 2, 2006. This application is also related to U.S. Pat. Nos. 5,874,500, 6,063,061, 6,066,325, 6,166,130, and 6,458,889. The contents of each of these filings are hereby incorporated by reference.STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT[0002]NOT APPLICABLEREFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISK[0003]NOT APPLICABLEBACKGROUND OF THE INVENTION[0004]U.S. Pat. No. 5,162,430, issued Nov. 10, 1992, to Rhee et al. discusses collagen-synthetic polymer conjugates prepared by covalently binding collagen to synthetic hydrophilic polymers such as various derivatives of polyethylene glycol. U.S. Pat. No. 5,324,775, issued Jun. 28, 1994, to Rh...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/70A61K38/48B32B5/18A61P17/02A61P7/04B32B9/04A61K9/00A61K38/36
CPCA61L24/001A61L24/0031A61L24/06A61L31/06A61L31/145A61L31/146C08L71/02A61L31/044A61L24/0036A61L24/046Y10T428/249983A61K38/363A61K38/4833A61P17/02A61P7/04A61L24/10A61L27/40A61L27/56A61K9/70A61K47/34A61K47/42
Inventor RHEE, WOONZA M.REICH, CARY J.OSAWA, A. EDWARDVEGA, FELIX
Owner BAXTER INT INC
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