Embolism protection devices

• US 20040093015A1
• Filed: 04/16/2003
• Published: 05/13/2004
• Est. Priority Date: 08/01/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Lumen Biomedical, Inc.
• Inventors: Ogle, Matthew F.
• Granted Patent: US 7,303,575 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12027 Type of occlusion A61B17/12113 takes precedence
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/04 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

Abstract

Embolism protection devices can be formed with a biocompatible expandable polymer that can expand upon release within a patient'"'"'s vessel. Upon release, the structure can be configured to filter flow through the vessel. The material of the embolism protection devices can release one or more biologically active agents, such as a thrombolitic agent, including, for example, tPA. Alternatively or additionally, the embolism protection device can be connected to a tether that elutes one or more biologically active agents.

Claims

1. An embolism protection device comprising a biocompatible expandable polymer, wherein the expandable polymer expands upon release within a patient'"'"'s vessel into a structure configured to filter flow through the vessel.

2. The embolism protection device of claim 1 wherein the expandable polymer comprises a hydrogel.

3. The embolism protection device of claim 2 wherein the polymer expands upon contact with an aqueous solution.

4. The embolism protection device of claim 1 wherein the expandable polymer comprises polyacrylamide.

5. The embolism protection device of claim 1 wherein the expandable polymer comprises an polyether-polyurethane polymer or a polycarbonate-polyurethane polymer.

6. The embolism protection device of claim 1 wherein the expandable polymer comprises a memory polymer.

7. The embolism protection device of claim 6 wherein the polymer expands upon heating to body temperature.

8. The embolism protection device of claim 1 comprising a compressible polymer.

9. The embolism protection device of claim 8 wherein the compressible polymer comprises a foam.

10. The embolism protection device of claim 1 comprising a structural polymer.

11. The embolism protection device of claim 1 comprising a fabric.

12. The embolism protection device of claim 11 wherein the fabric covers the outer surface of the embolism protection device that is oriented for contacting the vessel wall.

14. The embolism protection device of claim 1 wherein the biocompatible expandable polymer comprises a mat of interwoven fibers.

15. The embolism protection device of claim 1 comprising a block copolymer.

16. The embolism protection device of claim 15 wherein the block copolymer comprises a hydrogel block.

17. The embolism protection device of claim 15 wherein the block copolymer comprises a polyester block and a polyacrylamide block.

18. The embolism protection device of claim 1 wherein the device expands at least about 50 volume percent.

19. The embolism protection device of claim 1 wherein the expanded device has a diameter from about 50 microns to about 35 millimeters.

20. The embolism protection device of claim 1 wherein the device has suitable dimensions for insertion within a vessel of a mammal.

21. The embolism protection device of claim 1 wherein the device has a suitable dimension for placement in a human aorta.

22. The embolism protection device of claim 1 wherein the device has a suitable dimension for placement in a human coronary artery.

23. The embolism protection device of claim 1 wherein following expansion the device has a porosity to block the passage of a substantial majority of particulates with a diameter of at least about 0.2 millimeters and allows the flow through the device of a substantial majority of particulates with a diameter of no more than about 0.001 millimeters.

24. The embolism protection device of claim 1 comprising a resorbable polymer.

25. The embolism protection device of claim 1 further comprising a biologically active agent that elutes from the device when in contact with the flow in a patient'"'"'s vessel.

26. The embolism protection device of claim 25 wherein the biologically active agent comprises a thrombolytic agent.

27. The embolism protection device of claim 25 wherein the biologically active agent comprises tPA.

28. The embolism protection device of claim 1 wherein the porous structure blocks a substantial majority of particulates with a diameter of at least about 0.1 millimeters and allows the flow through the device of a substantial majority of particulates with a diameter of no more than about 0.01 millimeters.

29. A method for reducing cellular damage resulting from an embolus, the method comprising delivering into a patient'"'"'s vessel an embolic protection device of claim 1.

30. The method of claim 29 further comprising administering a thrombolytic agent in the vicinity of the embolism protection device within the patient'"'"'s vessel.

13. The embolism protection device of claim II wherein the fabric covers one end of the embolism protection device that is oriented for the passage of flow through the device while not covering the other end.

31. An embolism protection device comprising a biocompatible resorbable polymer forming a porous structure having a configuration to filter flow through a patient'"'"'s vessel.

32. The embolism protection device of claim 31 wherein the resorbable polymer is selected from the group consisting of polysaccharides, hydroxyethyl starch, derivatives of gelatin, polyvinylpyrrolidone, polyvinyl alcohol, poly[N-(2-hydroxypropyl) methacrylamide], poly(hydroxyacids), poly(epsilon-caprolactone), polylactic acid, polyglycolic acid, poly(dimethyl glycolic acid), poly(hydroxybutyrate), copolymers thereof and mixtures thereof.

33. A method for reducing cellular damage resulting from an embolus, the method comprising delivering into a patient'"'"'s vessel an embolic protection device of claim 31.

34. An embolism protection device comprising a polymer forming a porous structure and a biologically active agent that elutes from the device when the device is in contact with flow within a patient'"'"'s vessel, the porous structure having a configuration to filter flow through the patient'"'"'s vessel.

35. The embolism protection device of claim 34 wherein the biologically active agent comprises a thrombolytic agent, an anti-platelet agent, an anti-coagulation agent, a growth factor or a combination thereof.

36. The embolism protection device of claim 34 wherein the biologically active agent comprises tPA.

37. The embolism protection device of claim 34 wherein the biologically active agent comprises a vector the results in in vivo production of tPA.

38. The embolism protection device of claim 34 wherein the polymer comprises a hydrogel.

39. The embolism protection device of claim 34 wherein the polymer comprises a block copolymer.

40. A method for reducing cellular damage resulting from an embolus, the method comprising delivering into a patient'"'"'s vessel an embolic protection device of claim 34.

41. An embolism protection device comprising a first section and a compositionally distinct second section wherein the first section has a different average composition from the average composition of the second section and wherein the first section and the second section are configured for placement within a patient'"'"'s vessel with a substantial fraction of flow passing sequentially through the first section and the second section.

42. The embolism protection device of claim 41 wherein the first section comprises a resorbable polymer.

43. The embolism protection device of claim 41 wherein the first section comprises a biologically active agent.

44. The embolism protection device of claim 41 wherein the first section can be separated from the second section.

45. A method for reducing cellular damage resulting from an embolus, the method comprising delivering into a patient'"'"'s vessel an embolic protection device of claim 41.

46. A system for providing protection from emboli comprising an embolic protection device and a delivery tool that is configured for releasing the embolism protection device into a vessel from the catheter wherein the embolism protection device comprises a biocompatible expandable polymer.

47. The system of claim 46 wherein the delivery tool comprises a sheath within which the embolism protection device can be placed.

48. The system of claim 46 wherein the delivery tool comprises a cannula through which the embolism protection device can be delivered.

49. The system of claim 46 further comprising a retraction device that interfaces with the embolism protection device for removal from the patient'"'"'s vessel.

50. The system of claim 46 further comprising a guide wire with a hollow core.

51. The system of claim 50 further comprising a cannulated syringe with a fitting for attachment to the guide wire.

52. A method for reducing or eliminating adverse effects of an embolus, the method comprising:

delivering an embolism protection device within a vessel of a patent wherein the device is tethered with a tether and wherein the embolism protection device filters flow within the vessel; and

administering a biologically active agent through the tether.

53. The method of claim 52 wherein the biologically active agent comprises tPA in a suitable biocompatible carrier.

54. The method of claim 52 wherein the embolism protection device comprises an expandable polymer.

55. The method of claim 53 further comprising removing the embolism protection device from the patient'"'"'s vessel.