ARTICLES AND METHODS OF TREATING VASCULAR CONDITIONS

• US 20140364404A1
• Filed: 08/22/2014
• Published: 12/11/2014
• Est. Priority Date: 03/13/2009
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cleek, Robert L., Drumheller, Paul D., Holland, Theresa A.
• Granted Patent: US 10,314,783 B2
• Time in Patent Office: Days
• US Class Current: 514/180
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• 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 47/40 Cyclodextrins; Derivatives thereof
• 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 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 29/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

The present invention relates to articles and methods of treating vascular conditions with a thixotropic, turbid, bioactive agent-containing gel material capable of being essentially removed from an implantation site upon re-establishment of fluid flow at the implantation site.

Claims

1. A method of treating a vascular condition comprising:

providing a thixotropic, turbid, gel material containing at least one bioactive agent capable of treating vascular tissue in sufficient amounts to treat said vascular condition in said vascular tissue upon release of said bioactive agent from said gel material;

administering said gel material to a vascular treatment site within an interior space of a blood vessel;

allowing said gel material to remain at said vascular treatment site for a dwell time sufficient to release said bioactive agent from said gel material.

2. The method of claim 1 wherein said gel material does not occlude vascular structures upon introduction into flowing blood.

3. The method of claim 2 further comprising removing said gel material from within said blood vessel.

4. The method of claim 1 wherein said bioactive agent has one of anti-inflammatory properties and anti-proliferative properties.

5. The method of claim 1 wherein said bioactive agent is selected from the group consisting of dexamethasone, estradiol, carvedilol, and cilostazol.

6. The method of claim 1 wherein said vascular disease is intimal hyperplasia.

7. The method of claim 1 wherein administrating said gel material includes injection through one of a needle-containing syringe, a catheter, and balloon.

8. The method of claim 1 wherein the gel material is applied to at least a portion of an outer surface of a medical device comprising one of a stent-graft and a balloon.

9. A method of treating a vascular condition comprising:

identifying a vascular structure in need of treatment or repair;

isolating said vascular structure;

applying means for stopping any blood flow in said vascular structure;

providing a thixotropic, turbid, gel material containing at least one bioactive agent capable of treating vascular tissue in sufficient amounts to inhibit vascular disease in said vascular tissue upon release of said bioactive agent from said gel material;

administering said gel material to a vascular treatment site within an interior space of the vascular structure;

allowing said gel material to remain at said vascular treatment site for a dwell time sufficient to release said bioactive agent from said gel material;

removing said means for stopping blood flow;

allowing said gel material to be removed within said vascular structure by flowing blood in the vascular structure; and

closing said vascular structure.

10. The method of claim 9 wherein said gel material does not occlude vascular structures upon introduction into flowing blood.

11. The method of claim 9 wherein said bioactive agent has one of anti-inflammatory properties and anti-proliferative properties.

12. The method of claim 9 wherein said bioactive agent is selected from the group consisting of dexamethasone, estradiol, carvedilol, and cilostazol.

13. The method of claim 9 wherein administrating said gel material includes injection through one of a needle-containing syringe, a catheter, and a balloon.

14. The method of claim 9, wherein the gel material is applied to at least a portion of an outer surface of a medical device comprising one of a stent-graft and a balloon.

15. A method of treating a vascular condition comprising:

providing a cyclodextrin polymer-based composition comprising cyclodextrin, a polymer, and a pharmacologically effective amount of at least one drug;

wherein the polymer comprises ethylene glycol units that can form a hydrogel with the cyclodextrin, wherein the cyclodextrin and the polymer self-assemble to form a hydrogel by spontaneous association and are present in the composition in respective amounts effective to make the hydrogel thixotropic and injectable into the body of a person through a needle, and wherein the hydrogel forms a matrix for the drug such that when the composition is injected into the body of the person, the drug is released from the hydrogel in a sustained manner,

administering said hydrogel material to a vascular treatment site within an interior space of a blood vessel; and

allowing said hydrogel material to remain at said vascular treatment site for a dwell time sufficient to release said bioactive agent from said hydrogel material.