Non-biodegradable drug-eluting sleeves for intravascular devices

• US 20050154449A1
• Filed: 11/29/2004
• Published: 07/14/2005
• Est. Priority Date: 07/31/2002
• Status: Abandoned Application

• Current Assignee: David Elmaleh
• Original Assignee: David Elmaleh
• Inventors: Elmaleh, David R.
• Application Number:
  US10/999,840
• Publication Number:
  US 20050154449A1
• Time in Patent Office: Days
• US Class Current: 623/1.150
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

An intravascular device having a removable biocompatible sleeve pulled substantially over the length of the device is provided. The device may be a substantially expandable tubular body defined by a mesh framework. The sleeve can include a plurality of perforations to permit fluid communication with the mesh framework. The sleeve may contain a pharmacotherapeutic agent to permit treatment of certain conditions. After deployment to a site of interest, the device and more specifically, the sleeve, can provide local delivery of sustained or controlled therapeutic dose of the suitable pharmacotherapeutic agent.

Claims

1. An intravascular device comprising:

an expandable substantially tubular body defined by a mesh framework;

a removable non-biodegradable biocompatible sleeve for positioning over the mesh framework, the sleeve being flexible and extensible to permit expansion and movement with the body;

a layer of a pharmacotherapeutic agent on the sleeve; and

a plurality of perforations positioned on the sleeve to permit communication with the mesh framework.

2. A device as set forth in claim 1, wherein the mesh framework includes openings between filaments defining the framework, which openings substantially compliment the perforations on the sleeve.

3. A device as set forth in claim 1, wherein the biocompatible sleeve includes a substantially uniform thickness along the entire sleeve.

4. A device as set forth in claim 1, wherein the biocompatible sleeve is made from a polymer.

5. A device as set forth in claim 4, wherein the polymer includes at least one of polyurethane, polyester, polytetrafluoroethylene (PTFE), polyethylacrylate/polymethylmethacrylate, polylactide, polylactide-co-glycolide, polyamides, polydioxanone, polyvinyl chloride, polymeric or silicone rubber, collagen, thermoplastics, or a combination thereof.

6. A device as set forth in claim 1, wherein the biocompatible sleeve is constructed so that it minimizes failure of the expansion of the mesh framework.

7. A device as set forth in claim 1, wherein the pharmacotherapeutic agent includes at least one of an immunosuppressant, an antibiotic, a cell cycle inhibitor, an anti-inflammatory, an anticoagulant, an antiplatelet aggregation, an antibody, an antiallergen, and a gene therapy and a ceramide therapy compound.

8. A device as set forth in claim 1, wherein the layer of pharmacotherapeutic agent includes a coating of at least on pharmacotherapeutic agent on an outer surface of the sleeve.

9. A device as set forth in claim 8, further including a coating of at least one pharmacotherapeutic agent on an interior surface of the sleeve.

10. A device as set forth in claim 8, further including a coating of a biodegradable polymer having at least one pharmacotherapeutic agent dispersed therein on an interior surface of the sleeve.

11. A device as set forth in claim 1, wherein the layer of pharmacotherapeutic agent includes a coating of a biodegradable polymer having the pharmacotherapeutic agent dispersed therein on an outer surface of the sleeve.

12. A device as set forth in claim 11, further including a coating of at least one pharmacotherapeutic agent on an interior surface of the sleeve.

13. A device as set forth in claim 11, further including a coating of a biodegradable polymer having at least one pharmacotherapeutic agent dispersed therein on an interior surface of the sleeve.

14. A device as set forth in claim 1, wherein the layer of pharmacotherapeutic agent includes a layer within the sleeve.

15. A devices as set forth in claim 1, wherein the layer of pharmacotherapeutic agent includes a mixture of the agent throughout the sleeve.

17. A method as set forth in claim 11, further including positioning the plurality of perforations on the body of the sleeve in such a way that when the mesh framework is in an expanded state, the perforations on the sleeve are substantially aligned with openings in the mesh framework.

16. A method of preparing an intravascular device, the method comprising:

providing an expandable substantially tubular body defined by a mesh framework;

providing a non-biodegradable, biocompatible, flexible and extensible sleeve having opposite open ends, a body portion extending between the open ends, a layer of a pharmacotherapeutic agent on the body, and a plurality of perforations on the body;

expanding at least one open end of the sleeve along its diameter;

placing one end of the tubular body within the expanded open end of the sleeve; and

pulling the sleeve over the remainder of the tubular body until the sleeve substantially covers the tubular body.

18. A kit comprising:

a removable non-biodegradable biocompatible sleeve for positioning over a mesh framework of a substantially tubular intravascular device,

the sleeve being flexible and extensible to permit expansion and movement with the mesh framework, and including

a layer of a pharmacotherapeutic agent; and

a plurality of perforation to permit communication with the mesh framework.