Aqueous compositions and methods for bone hemostasis

Patent metadata

Field	Value
Publication number	US-9512277-B2
Application number	US-201213663098-A
Country	US
Kind code	B2
Filing date	Oct 29, 2012
Priority date	Oct 28, 2011
Publication date	Dec 6, 2016
Grant date	Dec 6, 2016

Abstract

Bone hemostat compositions, and methods for their use and manufacture are provided. Exemplary hemostatic compositions include polymeric components such as random and non-random copolymers, natural polymers, ceramics, reactive group polymers, and combinations thereof. Bone compositions may be used during surgical procedures, and may be applied to bone to inhibit or prevent bleeding from bone.

First claim

What is claimed is:

1. A biocompatible composition for use as a bone hemostat, the composition comprising:
an oxazoline polymer;
water present within a range from about 20% to about 45% by weight of the composition; and
a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight (Mw) within a range from about 9800 Mw to about 16300 Mw.

2. A biocompatible composition according to claim 1 , wherein the polyoxyethylene-polyoxypropylene block copolymer is a triblock copolymer.

3. A biocompatible composition according to claim 1 , wherein the polyoxyethylene-polyoxypropylene block copolymer has a molecular weight (Mw) within a range from about 9800 Mw to about 14600 Mw.

4. A biocompatible composition according to claim 1 , wherein the block copolymer comprises a percentage of polyethylene oxide within a range from about 60% to about 80%.

5. A biocompatible composition according to claim 1 , wherein the block copolymer comprises a percentage of polypropylene oxide within a range from about 20% to about 40%.

6. A biocompatible composition according to claim 1 , wherein the polyoxyethylene-polyoxypropylene block copolymer comprises 202 ethylene oxide units and 56 propylene oxide units.

7. A biocompatible composition according to claim 1 , wherein:
the polyoxyethylene-polyoxypropylene block copolymer is present within a range from about 20% to about 80% by weight of the composition.

8. A biocompatible composition according to claim 1 , further comprising a natural polymer selected from the group consisting of a gelatin, chitosan, and collagen.

9. A biocompatible composition according to claim 1 , further comprising a cross linked natural polymer, wherein:
the polyoxyethylene-polyoxypropylene block copolymer is present within a range from about 20% to about 40% weight of the composition,
the cross linked natural polymer is present within a range from about 20% to about 40% weight of the composition, and
the natural polymer comprise a member selected from the group consisting of gelatin, chitosan, and collagen.

10. A biocompatible composition according to claim 1 , further comprising an ethylene glycol polymer, wherein:
the oxazoline polymer is present within a range from about 2% to about 10% by weight of the composition.

11. A biocompatible composition according to claim 1 , further comprising an ethylene glycol polymer and cross linked gelatin particles, wherein:
the water is present at about 24.4% by weight of the composition,
the polyoxyethylene-polyoxypropylene block copolymer is present at about 26.7% weight of the composition,
the ethylene glycol polymer is present at about 13.3% by weight of the composition,
the oxazoline polymer is present at about 2.7% by weight of the composition, and
the cross linked gelatin particles are present at about 33.3% weight of the composition.

12. A biocompatible composition according to claim 1 , further comprising an ethylene glycol polymer and a random alkylene oxide copolymer.

13. A biocompatible composition according to claim 1 , further comprising an ethylene glycol polymer, a random alkylene oxide copolymer, and cross linked gelatin particles, wherein:
the water is present at about 27% by weight of the composition,
the polyoxyethylene-polyoxypropylene block copolymer is present at about 20% weight of the composition,
the ethylene glycol polymer is present at about 10% by weight of the composition,
the random alkylene oxide copolymer is present at about 5% by weight of the composition,
the oxazoline polymer is present at about 3% by weight of the composition, and
the cross linked gelatin particles are present at about 35% weight of the composition.

14. A biocompatible composition according to claim 1 , further comprising an ethylene glycol polymer, a random alkylene oxide copolymer and ceramic particles.

15. The biocompatible composition according to claim 14 , wherein the ceramic particles comprise a member selected from the group consisting of Si-substituted ceramic particles and Sr-substituted ceramic particles.

16. The biocompatible composition according to claim 14 , wherein the ceramic particles have a particle size less than about 150 μm.

17. A biocompatible composition according to claim 1 , further comprising an ethylene glycol polymer, a random alkylene oxide copolymer, cross linked gelatin particles, and ceramic particles, wherein:
the water is present at about 27% by weight of the composition,
the polyoxyethylene-polyoxypropylene block copolymer is present at about 20% weight of the composition,
the ethylene glycol polymer is present at about 10% by weight of the composition,
the random alkylene oxide copolymer is present at about 5% by weight of the composition,
the oxazoline polymer is present at about 3% by weight of the composition,
the cross linked gelatin particles are present at about 30% weight of the composition, and
the ceramic particles are present at about 5% weight of the composition.

18. The biocompatible composition according to claim 17 , wherein the random alkylene oxide copolymer comprises an ethylene oxide to propylene oxide ratio of about 1:1.

19. A method of treating a patient, the method comprising:
administering a biocompatible composition to a bone of the patient,
wherein the biocompatible composition comprises: an oxazoline polymer, water present within a range from about 20% to about 45% by weight of the biocompatible composition, and a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight (Mw) within a range from about 9800 Mw to about 16300 Mw.

20. A method of manufacturing a biocompatible composition for use in treating a bone of a patient, the method comprising:
mixing water, a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight (Mw) within a range from about 9800 Mw to about 16300 Mw, and an oxazoline polymer to form the biocompatible composition, wherein: the water is present within a range from about 20% to about 45% by weight of the biocompatible composition.

21. A biocompatible composition according to claim 17 , wherein the ceramic particles comprise silicon-substituted hydroxyapatite.

22. A biocompatible composition according to claim 17 , wherein the ceramic particles comprise strontium-substituted hydroxyapatite.

23. A biocompatible composition according to claim 1 , further comprising a non-random copolymer component, wherein the non-random copolymer component is different from the polyoxyethylene-polyoxypropylene block copolymer.

24. A biocompatible composition according to claim 1 , wherein the oxazoline polymer is a polyoxazoline.

25. A biocompatible composition according to claim 1 , wherein the oxazoline polymer is present at about 3% by weight of the composition.

Assignees

• Baxter Int
• Baxter Healthcare Sa
• Baxter Int
• Baxter Healthcare Sa

Inventors

• Gorna Katarzyna I
• Goessl Andreas
• Gulle Heinz

Classifications

• A61P19/08

  for bone diseases, e.g. rachitism, Paget's disease · CPC title

• A61B2017/00933

  bone or bone-like · CPC title

• A61B17/56

  Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor · CPC title

• A61K31/765 Primary

  Polymers containing oxygen · CPC title

• A61L24/046

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds (A61L24/043 takes precedence) · CPC title