Medical devices for delivering a therapeutic agent and method of preparation

• US 20060085064A1
• Filed: 11/30/2005
• Published: 04/20/2006
• Est. Priority Date: 04/26/1993
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tuch, Ronald J.
• Granted Patent: US 7,419,696 B2
• Time in Patent Office: Days
• US Class Current: 623/1.430
• 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 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/236 Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/432 Inhibitors, antagonists A61L2300/402 - A61L2300/43 take precedence
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/044 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/043 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• 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 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/145 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A device useful for localized delivery of a therapeutic agent is provided. The device includes a structure including a porous polymeric material and an elutable therapeutic agent in the form of a solid, gel, or neat liquid, which is dispersed in at least a portion of the porous polymeric material. Methods for making a medical device having a blood-contacting surface is also provided. One method involves: providing a structure comprising a porous material; contacting the structure comprising a porous material with a concentrating agent to disperse the concentrating agent throughout at least a portion of the porous material; contacting the structure comprising a porous material and the concentrating agent with a solution of a therapeutic agent; and removing the therapeutic agent from solution within the porous material at the locations of the concentrating agent. Another method involves multiple immersion steps without the use of a concentrating agent.

Claims

1-25. -25. (canceled)

26. A medical system comprising:

a catheter having a dilatation balloon disposed on a distal end thereof; and

a deformable stent framework disposed on the dilatation balloon, wherein the stent includes at least one surface capable of contacting a site of vascular injury or trauma, the at least one surface comprising a porous material having dispersed therein an elutable therapeutic agent.

27. A medical system as claimed in claim 26 wherein the deformable stent framework is formed from a polymeric material, a metallic material, or a combination thereof.

28. A medical system as claimed in claim 26 wherein the elutable therapeutic agent is the form of a solid, gel, or neat liquid, which is dispersed in at least a portion of said porous polymeric material.

29. A medical system as claimed in claim 26 wherein said porous material comprises a film.

30. A medical system as claimed in claim 26 wherein said porous material comprises an integral portion of the device.

31. A medical system as claimed in any one of claims 26 to 31 wherein said porous material is a natural hydrogel, a synthetic hydrogel, silicone, polyurethane, polysulfone, cellulose, polyethylene, polypropylene, polyamide, polyester, polytetrafluoroethylene, or a combination of two or more of these materials.

32. A medical system as claimed in any one of claims 26 to 30 wherein said porous material comprises a non-swellable biostable polymer.

34. A medical system as claimed in claim 32 wherein the antithrombotic material is heparin, a heparin derivative or analog.

35. A medical system as claimed in any of one of claims 26 to 31 wherein said therapeutic agent is a peptidic drug.

36. A medical system as claimed in claim 26 wherein the stent has a generally cylindrical or sheet-like shape.

37. A method for making an intravascular medical device, said method comprising the steps of:

(a) providing a structure adapted for introduction into a blood vessel, the structure comprising a porous material;

(b) immersing said structure in a saturated solution of a therapeutic agent for a sufficient period of time to allow the solution to fill the porous material;

(c) removing the structure from the solution;

(d) drying the structure; and

(e) repeating steps (b) through (d) whereby to provide a therapeutic agent dispersed within the porous material.

38. A method as claimed in claim 37 further comprising a step of removing air bubbles from the porous material while immersed in the solution of the therapeutic agent.

39. A method as claimed in claim 38 wherein the step of removing air bubbles from the porous material is effected by applying ultrasonic energy, reduced pressure, elevated pressure, or a combination thereof, to the solution.

40. A method as claimed in any one of claims 37 to 39 further comprising the step of applying an overlayer of a polymer to said structure.

41. A method as claimed in any one of claims 37 to 39 wherein said porous material is a natural hydrogel, a synthetic hydrogel, silicone, polyurethane, polysulfone, cellulose, polyethylene, polypropylene, polyamide, polyester, polytetrafluoroethylene, or a combination of two or more of these materials.

42. A method as claimed in any one of claims 37 to 39 wherein said therapeutic agent is an antithrombotic material.