Impregnated polymer compositions and devices using them

• US 20060257355A1
• Filed: 05/10/2005
• Published: 11/16/2006
• Est. Priority Date: 05/10/2005
• Status: Abandoned Application

• Current Assignee: Abiomed, Inc. (Johnson & Johnson)
• Original Assignee: Abiomed, Inc. (Johnson & Johnson)
• Inventors: Stewart, Robert B., Bolt, William, Vaughan, Stephen
• Application Number:
  US11/127,058
• Publication Number:
  US 20060257355A1
• Time in Patent Office: Days
• US Class Current: 424/78.270
• 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 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 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 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

Compositions that include a polymer and an agent impregnated in the polymer are disclosed. In certain examples, the agent is a pharmacological agent that is impregnated in the polymer and may elute from the polymer into fluid, such as blood, lymph and the like.

Claims

1. A composition comprising:

a polymer; and

an effective amount of a pharmacological agent impregnated in the polymer.

2. The composition of claim 1, in which the pharmacological agent is an athrombogenic agent.

3. The composition of claim 1, in which the polymer is a biocompatible polymer.

4. The composition of claim 3, in which the polymer is selected from the group consisting of a polyether, a polyurethane, a polyesterurethane, a polyetherurethane, a polyetherurethaneurea, a polyester, a polycarbonate, a low density polyethylene, a medium density polyethylene, a high density polyethylene, a polyethylene terephthalate, a polyvinyl chloride, a polypropylene, a polystyrene, a polyamide, a polyacrylamide, a polyacrylate, and combinations thereof.

5. The composition of claim 2, in which the polymer is a polyurethane and the athrombogenic agent is a heparin.

6. The composition of claim 5, in which the heparin is selected from the group consisting of human heparin, bovine heparin, porcine heparin, heparin sulfate, a low molecular weight heparin, a heparin analogue, a synthetic heparin, a heparanoid, and combinations thereof.

7. The composition of claim 5, further comprising a heparin coated on at least one surface of the polyurethane.

8. The composition of claim 1, further comprising a complexing agent.

9. The composition of claim 8, in which the complexing agent is selected from the group consisting of a benzalkonium salt, an ammonium salt, a tridodecylammonium chloride, a cetylpyrimidine chloride, a sterylammonium chloride, and combinations thereof

10. The composition of claim 2, further comprising a complexing agent.

11. The composition of claim 10, in which the pharmacological agent is a heparin selected from the group consisting of human heparin, bovine heparin, porcine heparin, heparin sulfate, a low molecular weight heparin, a heparin analogue, a synthetic heparin, a heparanoid, and combinations thereof.

12. The composition of claim 10, in which the polymer is a polyetherurethane or a polyesterurethane, the athrombogenic agent is a heparin and the complexing agent is benzalkonium chloride.

13. The composition of claim 1, in which the polymer comprises a compound having formula (I)

in which each of R₁ and R₂ is independently selected from the group consisting of a saturated hydrocarbon, an unsaturated hydrocarbon, a substituted phenyl, an unsubstituted phenyl, a phenoxy, a toluene isocyanate, a toluene diisocyanate, a polyisocyanate, and wherein x and y are each between about 50 to about 1,000.

14. The composition of claim 13, in which each of R₁ and R₂ independently comprises a compound having formula (II)

(II) wherein each of

and R₄ is independently an aromatic or an aliphatic cyclic hydrocarbon and n is between about 1 and about 500.

15. The composition of claim 10, in which the polymer is a block polystyrene co-polymer, the athrombogenic agent is a heparin and the complexing agent is benzalkonium chloride.

16. The composition of claim 15, in which the block polystyrene co-polymer comprises a compound having formula (III)

wherein R₅ is a diene and wherein each of a, b and c is independently between about 10 and about 1,000.

17. The composition of claim 13, further comprising an additional pharmacological agent coated on at least one surface of the polymer.

18. The composition of claim 13, further comprising a complexing agent.

19. The composition of claim 1, comprising about 0.05 to about 0.5 equivalents of the pharmacological agent per equivalent of the polymer.

20. The composition of claim 1, further comprising a surface coating on the composition in which pharmacological agent has been homogeneously incorporated into the surface coating.

21. A device constructed and arranged for use as a ventricle of a human heart and comprising a composition that comprises a polymer and a pharmacological agent impregnated in the polymer.

22. The device of claim 21, in which the polymer is a polyurethane and the pharmacological agent is a heparin.

23. The device of claim 22, in which the heparin is complexed with a complexing agent.

24. The device of claim 22, in which the heparin is selected from the group consisting of human heparin, bovine heparin, porcine heparin, heparin sulfate, a low molecular weight heparin, a heparin analogue, a synthetic heparin, a heparanoid and combinations thereof.

25. The device of claim 21, further comprising:

a first chamber;

an input port in fluid communication with the first chamber and configured to allow fluid flow into the first chamber; and

an output port in fluid communication with the first chamber and configured to allow fluid from the first chamber to an arterial system of a human.

26. The device of claim 25, in which one or both of the input port and the output port comprise a valve.

27. The device of claim 21, further comprising:

a first chamber;

an input port in fluid communication with the first chamber;

a second chamber in fluid communication with the first chamber;

a valve configured to control fluid flow from the first chamber to the second chamber; and

an output port in fluid communication with the second chamber and configured to provide fluid flow to an arterial system of a human.

28. The device of claim 21, in which all blood contacting surfaces of the device comprise a composition that comprises a polymer and an athrombogenic agent impregnated in the polymer.

29. A ventricular assist device constructed and arranged to provide sustained release of a pharmacological agent.

30. The ventricular assist device of claim 29, further comprising a surface coating in which the pharmacological agent has been homogeneously incorporated into the surface coating.

31. The ventricular assist device of claim 29, in which the pharmacological agent is a heparin impregnated in a polyurethane.

32. The ventricular assist device of claim 29, further comprising:

a first chamber;

an input port in fluid communication with the first chamber and configured to allow fluid flow into the first chamber; and

an output port in fluid communication with the first chamber and configured to allow fluid from the first chamber to an arterial system of a human.

33. The ventricular assist device of claim 29, further comprising:

a first chamber;

an input port in fluid communication with the first chamber;

a second chamber in fluid communication with the first chamber;

a valve configured to control fluid flow from the first chamber to the second chamber; and

an output port in fluid communication with the second chamber and configured to provide fluid flow to an arterial system of a human.

34. A catheter comprising:

a bladder comprising a first pharmacological agent impregnated in the bladder; and

a tube connected to the bladder and operative to inflate the bladder.

35. The catheter of claim 34, in which the first pharmacological agent is a heparin.

36. The catheter of claim 34, in which the bladder comprises a polyurethane.

37. The catheter of claim 36, in which the bladder further comprises a surface coating comprising a second pharmacological agent homogeneously incorporated in the surface coating, in which the second pharmacological agent may be the same or different than the first pharmacological agent.

38. The catheter of claim 37, in which the first and second pharmacological agents are each a heparin.

39. A method of facilitating treatment of thrombosis comprising providing a composition comprising a polymer impregnated with an athrombogenic agent.

40. The method of claim 39, further comprising configuring a device with the composition comprising the polymer impregnated with the athrombogenic agent.

41. The method of claim 40, further comprising configuring the device as a ventricular assist device.

42. The method of claim 40, further comprising configuring the device as a stent.

43. The method of claim 40, further comprising configuring the device as a catheter.