Drug Delivery Medical Device

• US 20100015200A1
• Filed: 07/16/2009
• Published: 01/21/2010
• Est. Priority Date: 07/17/2008
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: Neet, John, McClain, James B., Taylor, Douglas
• Granted Patent: US 9,486,431 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2002/30535 Special structural features of bone or joint prostheses not otherwise provided for
• CPC Class Codes: A61F 2250/0058 Additional features; Implant or prostheses properties not otherwise provided for
• CPC Class Codes: A61K 31/20 having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
• CPC Class Codes: A61K 31/7088 Compounds having three or more nucleosides or nucleotides
• CPC Class Codes: A61K 31/7105 Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, 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 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61L 17/005 containing a biologically active substance, e.g. a medicament or a biocide
• CPC Class Codes: A61L 17/145 Coating
• CPC Class Codes: A61L 2300/406 Antibiotics
• 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 2300/426 Immunomodulating agents, i.e. cytokines, interleukins, interferons
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/63 Crystals
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/34 Macromolecular materials
• 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 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/08 : Materials for coatings
• CPC Class Codes: A61L 29/085 : Macromolecular materials
• CPC Class Codes: A61L 29/14 : Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 29/148 : Materials at least partially resorbable by the body
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/08 : Materials for coatings
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

Abstract

Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on said substrate, wherein said coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within said coating and on said substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of said medical device in the body of said subject a portion of said pharmaceutical agent and/or active biological agent is delivered at said intervention site along with at least a portion of said polymer and/or a at least a portion of said pharmaceutical carrying agents.

Claims

1. A medical device comprising:

a substrate; and

a coating on at least a portion of said substrate,

wherein the coating comprises a plurality of layers, wherein at least one layer comprises a pharmaceutical agent that is crystalline, and

wherein the device is adapted to free at least a portion of the coating from the substrate upon stimulation of the coating.

6. The device of any of claims 1-2, wherein the crystalline pharmaceutical agent is not a microcapsule.

11. The device of any of claims 1-5, wherein the substrate comprises a balloon.

12. The device of one of claims 1-5, wherein the coating comprises at least one of a non-absorbable polymer and a bioabsorbable polymer.

13. The device of claim 1-2, wherein the pharmaceutical agent and a polymer are in the same layer, in separate layers, or form overlapping layers.

14. The device of claim 1, wherein the plurality of layers comprise five layers deposited as follows:

a first polymer layer, a first pharmaceutical agent layer, a second polymer layer, a second pharmaceutical agent layer and a third polymer layer.

2. A medical device comprising:

a substrate; and

a coating on at least a portion of said substrate,

wherein said coating is at least partially continuous, has at least one portion conformal to the substrate, and comprises a pharmaceutical agent that is crystalline, and

wherein the device is adapted to free at least a portion of the coating from the substrate upon stimulation of the coating.

3. A medical device comprising:

a substrate; and

a coating on at least a portion of said substrate,

wherein said coating comprises an active agent, and

wherein the device is adapted to free greater than 35% of the coating from the substrate upon a single stimulation of the coating.

7. The device of any of claims 3, wherein the stimulation lasts at most 20 seconds.

4. A medical device comprising:

a substrate; and

a coating on at least a portion of said substrate,

wherein said coating comprises an active agent,

wherein the coating is patterned, and

wherein at least a portion of the coating is adapted to free from the substrate upon stimulation of the coating.

8. The device of any claims of 4, wherein the patterned coating comprises at least two different shapes.

5. A medical device comprising:

a substrate; and

a coating on at least a portion of said substrate,

wherein the coating comprises a plurality of layers, wherein at least one layer comprises an active biological agent, and

wherein the device is adapted to free at least a portion of the coating from the substrate upon stimulation of the coating.

9. The device of claim 5, wherein the active biological agent comprises an active secondary, tertiary or quaternary structure.

10. The device of claim 5, wherein the active biological agent comprises growth factors, cytokines, peptides, proteins, enzymes, glycoproteins, nucleic acids, antisense nucleic acids, fatty acids, antimicrobials, vitamins, hormones, steroids, lipids, polysaccharides, carbohydrates, a hormone, gene therapies, RNA, siRNA, and/or cellular therapies such as stem cells and/or T-cells.

15. The device of claim 5, wherein the plurality of layers comprise five layers deposited as follows:

a first polymer layer, a first active biological agent layer, a second polymer layer, a second active biological agent layer and a third polymer layer.

16. A method comprising:

providing a medical device, wherein the medical device comprises a substrate and a coating on at least a portion of said substrate, and wherein the coating comprises a plurality of layers, wherein at least one layer comprises a pharmaceutical agent that is crystalline, and

freeing at least a portion of the coating from the substrate upon stimulating the coating with a stimulation.

21. The method of any of claims 16-17, wherein the crystalline pharmaceutical agent is not a microcapsule.

22. The method of claim 16, wherein the stimulation lasts at most 20 seconds.

23. The method of one of claims 16-20, wherein the substrate comprises a balloon.

24. The method of one of claims 16-20, wherein the coating further comprises at least one of a non-bioabsorbable polymer and a bioabsorbable polymer.

25. The method of claim 16, wherein at least one of the layers comprises the pharmaceutical agent.

26. The method of claim 16, wherein at least one of the layers comprises a polymer.

27. The method of claim 16, wherein the pharmaceutical agent and a polymer are in the same layer, in separate layers, or form overlapping layers.

28. The method of claim 16, wherein the plurality of layers comprise five layers deposited as follows:

a first polymer layer, a first pharmaceutical agent layer, a second polymer layer, a second pharmaceutical agent layer and a third polymer layer.

17. A method comprising:

providing a medical device, wherein the medical device comprises a substrate and a coating on at least a portion of said substrate, wherein said coating is at least partially continuous, has at least one portion conformal to the substrate, and comprises a pharmaceutical agent that is crystalline, and

freeing at least a portion of the coating from the substrate upon stimulating the coating with a stimulation.

18. A method comprising:

providing a medical device, wherein the medical device comprises a substrate and a coating on at least a portion of said substrate, and wherein said coating comprises an active agent, and

freeing greater than 35% of the coating from the substrate upon stimulating the coating with a stimulation.

19. A method comprising:

providing a medical device, wherein the medical device comprises a substrate and a coating on at least a portion of said substrate, wherein said coating comprises an active agent, and wherein the coating is patterned, and

freeing at least a portion of the coating from the substrate upon stimulating the coating with a stimulation.

20. A method comprising:

providing a medical device, wherein the medical device comprises a substrate and a coating on at least a portion of said substrate, and wherein the coating comprises a plurality of layers, wherein at least one layer comprises an active biological agent, and

freeing at least a portion of the coating from the substrate upon stimulating the coating with a stimulation.

29. The method of claim 20, wherein the plurality of layers comprise five layers deposited as follows:

a first polymer layer, a first active biological agent layer, a second polymer layer, a second active biological agent layer and a third polymer layer.