IP Library Granted Patent US 10,675,378
Granted Patent B2
US 10,675,378 · App. 16/401,644 · Granted Jun 9, 2020

Biocompatible phase invertible proteinaceous compositions and methods for making and using the same

Inventors: Ronald Dieck (Palo Alto, CA); Ian J. Handley (Mountain View, CA); Neil Winterbottom (Mountain View, CA); Joanna Wong (Mountain View, CA)
Assignee: Baxter International Inc.
A61L24/108A61L24/043A61L24/10A61L31/041
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Quick Facts
Patent No.
US 10,675,378
App. No.
16/401,644
Granted
Jun 9, 2020
Kind
B2
Abstract

Biocompatible phase invertible proteinaceous compositions and methods for making and using the same are provided. Phase invertible compositions in accordance with the invention are prepared by combining a liquid proteinaceous substrate and a liquid crosslinking composition, where the liquid crosslinking composition includes a macromolecular crosslinking agent. Also provided are kits for use in preparing the subject compositions. The subject compositions, kits and systems find use in a variety of different applications.

Claims (30)

1. A method of sealing a surgical site comprising:

(a) mixing

(a1) a liquid proteinaceous substrate with

(a2) a preformed liquid crosslinking composition comprising a macromolecular crosslinking agent which comprises a reaction product of an excess of a liquid aldehyde crosslinking agent and a glycosaminoglycan,

thereby forming a phase invertible composition; and

(b) applying the phase invertible composition to a surgical site of a patient in need thereof to seal the surgical site.

2. The method of claim 1 , wherein the glycosaminoglycan is hyaluronan.

3. The method of claim 1 , wherein liquid proteinaceous substrate comprises a proteinaceous material selected from the group consisting of: albumin, elastin, fibrin and soluble and insoluble forms of collagen and combinations thereof.

4. The method of claim 1 , wherein the proteinaceous substrate further comprises a tackifying agent.

5. The method of claim 1 , wherein the proteinaceous substrate further comprises a plasticizer.

6. The method of claim 1 , wherein the proteinaceous substrate further comprises a carbohydrate.

7. The method of claim 1 , wherein the liquid aldehyde crosslinking agent comprises glutaraldehyde.

8. The method of claim 7 , wherein the glutaraldehyde is heat stabilized.

9. The method of claim 1 , wherein liquid proteinaceous substrate comprises albumin.

10. The method of claim 1 , wherein the macromolecular crosslinking agent comprises at least one reactive moiety that can covalently bind proteins in the proteinaceous substrate.

11. The method of claim 1 , wherein the macromolecular crosslinking agent comprises bound crosslinking agent molecules and at least a portion of the bound crosslinking agent molecules retain a free crosslinking aldehyde moiety that can bind proteins in the proteinaceous substrate.

12. The method of claim 1 , wherein the macromolecular crosslinking agent is a reaction product of heat stabilized glutaraldehyde and hyaluronic acid.

13. The method of claim 1 , further comprising allowing the applied phase invertible composition to undergo a phase inversion from a first, liquid state to a second, solid state.

14. The method of claim 1 , wherein the surgical site is a vessel or an organ.

15. The method of claim 1 , wherein the phase invertible composition has an average burst of about 200 to about 850 mmHg, as measured at about room temperature.

16. The method of claim 1 , wherein forming the phase invertible composition comprises reacting the macromolecular crosslinking agent with proteins in the proteinaceous substrate.

17. The method of claim 16 , wherein reacting occurs at a pH from about 6 to about 8.

18. The method of claim 1 , wherein applying comprises flowing the phase invertible composition through a medical cannula or spraying the phase invertible composition onto the surgical site.

19. The method of claim 1 , wherein applying comprises delivering the phase invertible composition from a dual barrel syringe.

20. A method of sealing a surgical site comprising:

(a) mixing

(a1) a liquid proteinaceous substrate composition comprising about 30%-50% (w/w) albumin with

(a2) a preformed liquid crosslinking composition comprising a macromolecular crosslinking agent which comprises a reaction product of an excess of a liquid aldehyde crosslinking agent and a glycosaminoglycan, wherein the crosslinking composition comprises about 3%-10% (v/v) heat treated glutaraldehyde and about 0.1%-1% (w/v) hyaluronic acid,

thereby forming a phase invertible composition; and

applying the phase invertible composition to a surgical site of a patient in need thereof to seal the surgical site.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2019
From: DIECK, RONALD; HANDLEY, IAN J.; WINTERBOTTOM, NEIL; WONG, JOANNA
To: TENAXIS MEDICAL, INC.
Reel/Frame 049187/0646 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2019
From: MALLINCKRODT PHARMA IP TRADING DAC
To: BAXTER INTERNATIONAL INC.
Reel/Frame 049187/0725 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2019
From: TENAXIS MEDICAL, INC.
To: MALLINCKRODT PHARMA IP TRADING D.A.C.
Reel/Frame 049187/0932 →
Continuity (5)
Continuation 14055712 · Oct 16, 2013
Continuation 13471746 · May 15, 2012
Continuation 12326835 · Dec 2, 2008
Provisional Application 60991867 · Dec 3, 2007
Related Publication 20190255214A1 · Aug 22, 2019