Polysaccharide particle mixture

• US 10,420,794 B2
• Filed: 12/22/2016
• Issued: 09/24/2019
• Est. Priority Date: 04/24/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Medina, Jennifer G., Hissong, James Britton, Myntti, Matthew F., Oliver, Dana A., Vaccaro, Brian J.
• Primary Examiner(s): Lau, Jonathan S
• Application Number:
  US15/389,430
• Publication Number:
  US 20170100427A1
• Time in Patent Office: 1,006 Days
• CPC Class Codes: A61K 31/045 Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
• CPC Class Codes: A61K 31/717 Celluloses
• CPC Class Codes: A61K 31/718 Starch or degraded starch, e.g. amylose, amylopectin
• CPC Class Codes: A61K 31/722 Chitin, chitosan
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0046 Ear
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61L 2/007 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: C08B 15/005 : Crosslinking of cellulose derivatives
• CPC Class Codes: C08B 37/003 : Chitin, i.e. 2-acetamido-2-deoxy-(beta-1,4)-D-glucan or N-acetyl-beta-1,4-D-glucosamine; Chitosan, i.e. deacetylated product of chitin or (beta-1,4)-D-glucosamine; Derivatives thereof
• CPC Class Codes: C08B 37/0042 : Carragenan or carragen, i.e. D-galactose and 3,6-anhydro-D-galactose, both partially sulfated, e.g. from red algae Chondrus crispus or Gigantia stellata; kappa-Carragenan; iota-Carragenan; lambda-Carragenan; Derivatives thereof
• CPC Class Codes: C08G 2210/00 : Compositions for preparing hydrogels
• CPC Class Codes: C08J 3/124 : Treatment for improving the free-flowing characteristics
• CPC Class Codes: C08L 1/26 : Cellulose ethers
• CPC Class Codes: C08L 1/286 : substituted with acid radicals, e.g. carboxymethyl cellulose [CMC] C08L1/282 takes precedence
• CPC Class Codes: C08L 2666/26 : Natural polymers, natural resins or derivatives thereof according to C08L1/00 - C08L5/00, C08L89/00, C08L93/00, C08L97/00 or C08L99/00
• CPC Class Codes: C08L 5/08 : Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

Tissue and other body structures may be protected using a dry, free-flowing, sterilized mixture of chitosan particles and oxidized polysaccharide particles in sealed packaging. The mixture may assist in returning an injured, inflamed or surgically repaired surface to a normal state, e.g., through one or more healing mechanisms such as modulation of an inflammatory response, phagocytosis, mucosal remodeling, reciliation or other full or partial restoration of normal function.

Claims

1. A composition comprising a dry, free-flowing, sterilized mixture of separate rehydratable particles comprising about 20 to about 95 wt. % of chitosan particles containing amino groups and about 80 to about 5 wt. % of oxidized polysaccharide particles containing aldehyde groups in sealed packaging, wherein the amino group functionality and molecular weight of the chitosan and the aldehyde group and molecular weight of the oxidized polysaccharide are such that the mixture of chitosan particles and separate oxidized polysaccharide particles are rehydratable in situ when removed from the sealed packaging and applied in a dry state to a surgical tissue site or wound moistened with bodily fluids such that the mixture of chitosan particles and separate oxidized polysaccharide particles will adhere to such tissue site or wound and will adhere to one another by inter-particle crosslinking reaction of amino groups on the chitosan particles with aldehyde groups on the polysaccharide particles, wherein the dry, free-flowing, sterilized mixture of chitosan and oxidized polysaccharide particles contains less than 10% wt. % water.

2. A composition according to claim 1 wherein the chitosan particles have a number average molecular weight of about 10 to about 500 kDa.

3. A composition according to claim 1 wherein the oxidized polysaccharide particles comprise oxidized starch particles.

4. A composition according to claim 1 wherein the mixture contains about 80 to about 20% of the chitosan particles and about 20 to about 80% of the oxidized polysaccharide particles.

5. A composition according to claim 1 wherein the mixture contains about 60 to about 40% of the chitosan particles and about 40 to about 60% of the oxidized polysaccharide particles.

6. A composition according to claim 1 wherein the mixture contains about 60 to about 40% of the chitosan particles and about 40 to about 60% of oxidized starch particles.

7. A composition according to claim 1 wherein the chitosan particles and oxidized polysaccharide particles are non-comminuted.

8. A composition according to claim 1 wherein the chitosan particles and-oxidized polysaccharide particles in the sealed packaging are uncrosslinked.

9. A composition according to claim 1 wherein the chitosan particles and oxidized polysaccharide particles are rehydratable in situ to form a gel on the tissue site or wound.

10. A composition according to claim 9 wherein the chitosan particles and oxidized polysaccharide particles provide a polysaccharide gel when rehydrated.

11. A composition according to claim 1 wherein the chitosan particles and oxidized polysaccharide particles contain a sufficiently low amount of collagen so as not to pose a potential risk of transmission of or infection with bovine spongiform encephalopathy (BSE) or variant Creutzfeldt-Jakob disease (vCJD).

12. A composition according to claim 1 wherein the dry, free-flowing, sterilized mixture of chitosan and oxidized polysaccharide particles are capable of forming a substantially continuous conformal protective layer over such tissue.

13. A composition according to claim 12 wherein the tissue comprises mucosal tissue.

14. A composition according to claim 13 wherein the mucosal tissue is in a nasal cavity.

15. A composition according to claim 13 wherein the mucosal tissue is in a sinus cavity.

16. A composition according to claim 12 wherein the tissue comprises an injured, inflamed or surgically repaired surface and the mixture assists in returning such injured, inflamed or surgically repaired surface to a normal state.

17. A composition according to claim 16 wherein the return of such surface to a normal state includes reciliation.

18. A composition according to claim 1 further comprising a sustained release therapeutic agent.

19. A composition according to claim 1 wherein the mixture of particles is inherently antimicrobial without requiring addition of a separate antimicrobial agent.