Coating material and medical device system including same

• US 9,682,175 B2
• Filed: 04/14/2014
• Issued: 06/20/2017
• Est. Priority Date: 09/28/2004
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Labrecque, Roger, Rogers, Lisa, Martakos, Paul, Herweck, Steve A., Karwoski, Theodore, Ferraro, Joseph F., Moodie, Geoffrey
• Primary Examiner(s): Arnold, Ernst V
• Application Number:
  US14/252,671
• Publication Number:
  US 20140308333A1
• Time in Patent Office: 1,163 Days
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 47/22 Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 47/44 Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14
• CPC Class Codes: A61L 2300/22 Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
• 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 2300/428 Vitamins, e.g. tocopherol, riboflavin
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/00 : Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

A coating material including a bio-absorbable cross-linked material and a cellular uptake inhibitor. The bio-absorbable cross-linked material includes two or more fatty acids cross-linked into a substantially random configuration by ester bonds. The coating material may be adhered to a medical device. A medical device system including a medical device and a coating is also included.

Claims

1. A coating material on an implantable medical device, wherein the coating material comprises:

a bio-absorbable cross-linked material;

a therapeutic agent; and

a cellular uptake inhibitor;

wherein the bio-absorbable cross-linked material comprises two or more fatty acids of a fish oil cross-linked into a random configuration by ester bonds to form a three-dimensional network of a gel.

2. The coating material of claim 1, wherein the cellular uptake inhibitor comprises alpha-tocopherol.

3. The coating material of claim 1, wherein the two or more fatty acids are omega-3 fatty acids.

4. The coating material of claim 3, wherein the two or more omega-3 fatty acids are selected from the group consisting of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and α

-linolenic acid (ALA).

5. The coating material of claim 1, wherein the medical device is a stent.

6. The coating material of claim 5, wherein the stent is formed of one or more substance selected from the group of substances consisting of stainless steel, nitinol alloy, nickel alloy, titanium alloy, cobalt-chromium alloy, ceramics, metals, plastics, or polymers.

7. The coating material of claim 1, wherein the medical device comprises a pre-treatment, and wherein the pre-treatment improves the adhesion of the coating to the medical device.

8. The coating material of claim 1, wherein the therapeutic agent comprises one or more agents selected from the group of agents consisting of antioxidants, anti-inflammatory agents, anti-coagulant agents, drugs to alter lipid metabolism, anti-proliferatives, anti-neoplastics, anti-fibrotics, immunosuppressive, tissue growth stimulants, functional protein/factor delivery agents, anti-infective agents, imaging agents, anesthetic agents, chemotherapeutic agents, tissue absorption enhancers, anti-adhesion agents, germicides, antiseptics, proteoglycans, gene delivery, polynucleotides, analgesics, prodrugs and polysaccharides.

9. The coating material of claim 1, wherein the coating material is configured to effect controlled release of the therapeutic agent.

10. The coating material of claim 1, wherein the two or more fatty acids cross-linked into a substantially random configuration by ester bonds are formed by heat curing or UV curing.

11. The coating material of claim 1, wherein the therapeutic agent comprises an agent selected from the group consisting of cerivastatin, cilostazol, fluvastatin, lovastatin, paclitaxel, pravastatin, rapamycin, and simvastatin.

12. The coating material of claim 1, wherein the coating material inhibits neointimal growth.

13. The coating material of claim 1, wherein the coating material promotes endothelialization.

14. The coating material of claim 1, wherein the gel is a flexible gel structure.

15. The coating material of claim 1, wherein the therapeutic agent remains pharmacologically effective after the coating material is cured.

16. The coating material of claim 1, wherein the two or more fatty acids cross-linked into a random configuration by ester bonds are formed by curing without the addition of external crosslinking agents.

17. The coating material of claim 1, wherein upon implantation in a patient there is no break-down of the coating into sub parts and substances which induce an inflammatory response.

18. A medical system comprising:

a medical device; and

a coating disposed on the medical device, wherein the coating includes

a bio-absorbable cross-linked material; and

a cellular uptake inhibitor;

wherein the bio-absorbable cross-linked material comprises two or more omega-3 fatty acids cross-linked into a random configuration by ester bonds to form a non-polymeric three-dimensional network.

19. The medical system of claim 18, further comprising a therapeutic agent mixed in with the bio-absorbable cross-linked material and the cellular uptake inhibitor.

20. The medical system of claim 18, wherein the two or more omega-3 fatty acids are derived from fish oil.