Implantable device for treating disease states and methods of using same

• US 20050064009A1
• Filed: 06/09/2004
• Published: 03/24/2005
• Est. Priority Date: 08/25/2000
• Status: Active Grant

• Current Assignee: Nexeon MedSystems, Inc.
• Original Assignee: Global Gene Therapies, Inc.
• Inventors: Bates, Mark C.
• Granted Patent: US 7,651,696 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• 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 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Methods and apparatus are provided for delivering drugs, gene vectors, naturally-occurring or synthetic hormones or proteins or other bioactive agents within a patient'"'"'s vasculature. In a preferred embodiment, the apparatus comprises a material that elutes or secretes a bioactive agent and is held in place within the patient'"'"'s vessel by an anchor. The material may comprise a biocompatible, and optionally, absorbable matrix, or a culture medium that sustains and nourishes stem cells, spleen cells or pancreatic islets or other beneficial cells. The anchor and material are sized and/or collapsible from a delivery configuration, in which the anchor and material may be delivered into the patient'"'"'s vasculature within a delivery sheath, to a deployed configuration, wherein the anchor engages an interior wall of the patient'"'"'s vessel. The apparatus of the invention may be temporarily or permanently implanted, and may in addition self reconfigure after a predetermined period of residency.

Claims

1. Apparatus for delivery of a bioactive substance within a vessel, the apparatus comprising:

an anchor expandable from a delivery configuration adapted for disposition within a delivery sheath, to a deployed configuration adapted for engagement of an interior surface of the vessel; and

a material comprising a bioactive substance, the material adapted to elute or secrete a bioactive agent into blood flowing through the anchor.

2. The apparatus of claim 1 further comprising a delivery sheath having proximal and distal ends, and a lumen extending therebetween, the anchor adapted for disposition within the lumen in the delivery configuration.

3. The apparatus of claim 2 further comprising an advancement device disposed within the delivery sheath lumen and extending proximal of a proximal end of the delivery sheath, the advancement device configured to expand the anchor from the delivery configuration to the deployed configuration.

4. The apparatus of claim 1 further comprising a retriever disposed within the delivery sheath lumen and extending proximal of a proximal end of the delivery sheath, the retriever configured to collapse the anchor from the deployed configuration to the delivery configuration.

5. The apparatus of claim 1, wherein the bioactive agent is chosen from the group consisting of gene therapy vectors, gene therapy sequences, drugs, naturally-occurring hormones, naturally-occurring proteins, synthetic proteins and synthetic hormones.

6. The apparatus of claim 1 wherein the bioactive substance comprises a culture medium containing a mass of cells selected from the group consisting of autologous stem cells, donor stem cells, autologous spleen cells, donor spleen cells, renal tubular cells, autologous pancreatic islets and donor pancreatic islets.

7. The apparatus of claim 5, wherein the drugs are chosen from the group consisting of thrombolytics, anticoagulants, antiplatelet medications, antibiotics, and chemotherapy drugs.

8. The apparatus of claim 7, wherein the thrombolytics are chosen from the group consisting of tissue plasminogen activator, streptokinase, and urokinase.

9. The apparatus of claim 7, wherein the anti-coagulants are chosen from the group consisting of coumadin, heparin, aspirin, direct thrombin inhibitors and GP IIb-IIIa inhibitors.

10. The apparatus of claim 6, wherein the gene therapy vectors are adapted for incorporation into genome of a portion of cells with which the vectors come into contact.

11. The apparatus of claim 3, wherein the advancement device is chosen from the group consisting of a guide wire, a guide tube, and a pusher.

12. The apparatus of claim 3, wherein the advancement device is coupled to the proximal end of the anchor.

13. The apparatus of claim 12, wherein the anchor is collapsible back to the delivery configuration.

14. The apparatus of claim 1, wherein the anchor comprises a resiliently expandable cage.

15. The apparatus of claim 1, wherein the anchor comprises a pair of resilient expandable legs.

16. The apparatus of claim 1, wherein the anchor comprises three or more resilient expandable legs.

17. The apparatus of claim 1 wherein the anchor includes a plurality of struts joined at the proximal and distal ends by bioabsorbable beads, the bioabsorbable beads comprising a material that dissolves after a predetermined time to permit the plurality of struts to reconfigure.

18. The apparatus of claim 1, wherein the material is chosen from the group consisting of a spongy material, a floppy elongated member adapted for multiple turns, and an expandable pellet.

19. The apparatus of claim 1, wherein the material is coupled to the anchor by an extensible band.

20. The apparatus of claim 1, wherein an outside layer surrounds the material.

21. The apparatus of claim 20, wherein the outside layer comprises a porous material that is coated with a drug to prevents biologic material from adhering to its surface.

22. The apparatus of claim 1, wherein one or more sensors are embedded within the material.

23. The apparatus of claim 22, wherein the sensors are used to measure physiological and biochemical properties in the blood stream, and then transmit the information concerning the physiological and biochemical properties to a receiving device.

24. Apparatus for treating atherosclerotic disease, the apparatus comprising:

an anchor expandable from a delivery configuration adapted for disposition within a delivery sheath, to a deployed configuration adapted for engagement of an interior surface of the vessel; and

a matrix disposed within the anchor, the matrix comprising a material adapted to elute or secrete apo-AI (Milano) protein or similar agent.

25. The apparatus of claim 24 further comprising a delivery sheath having proximal and distal ends, and a lumen extending therebetween, the anchor adapted for disposition within the lumen in the delivery configuration.

26. The apparatus of claim 24 further comprising an advancement device disposed within the delivery sheath lumen and extending proximal of a proximal end of the delivery sheath, the advancement device configured to expand the anchor from the delivery configuration to the deployed configuration.

27. The apparatus of claim 24 further comprising a retriever disposed within the delivery sheath lumen and extending proximal of a proximal end of the delivery sheath, the retriever configured to collapse the anchor from the deployed configuration to the delivery configuration.

28. The apparatus of claim 24 wherein the matrix comprises a culture medium for propagating the apo-AI (Milano) protein or similar agent.

29. The apparatus of claim 24 wherein the matrix comprises a bioabsorbable material that elutes or secretes the apo-AI (Milano) protein or similar agent during dissolution of the bioabsorbable material.

30. The apparatus of claim 24, wherein the anchor is coated or impregnated with a drug chosen from the group consisting of thrombolytics, anticoagulants, antiplatelet medications and antibiotics.

31. The apparatus of claim 26, wherein the advancement device is coupled to the proximal end of the anchor.

32. The apparatus of claim 31, wherein the anchor is collapsible back to the delivery configuration.

33. The apparatus of claim 24, wherein the anchor comprises a resiliently expandable cage.

34. The apparatus of claim 24, wherein the anchor comprises a pair of resilient expandable legs.

35. The apparatus of claim 34, wherein each resilient leg includes one or more barbs to provide improved engagement with the vessel.

36. The apparatus of claim 24, wherein the anchor comprises three or more resilient expandable legs that are connected at a hinge.

37. The apparatus of claim 36, wherein each resilient leg includes one or more barbs to provide improved engagement with the vessel.

38. The apparatus of claim 24 wherein the anchor includes a plurality of struts joined at the proximal and distal ends by bioabsorbable beads, the bioabsorbable beads comprising a material that dissolves after a predetermined time to permit the plurality of struts to reconfigure.

39. The apparatus of claim 24, wherein one or more sensors are embedded within the material.

40. The apparatus of claim 30, wherein the sensors are used to measure physiological and biochemical properties in the blood stream, and then transmit the information concerning the physiological and biochemical properties to a receiving device.

41. Apparatus for treating diabetes, the apparatus comprising:

an anchor expandable from a delivery configuration adapted for disposition within a delivery sheath, to a deployed configuration adapted for engagement of an interior surface of the vessel; and

a matrix disposed within the anchor, the matrix comprising a material adapted to elute or secrete a protein or hormone that mitigates diabetes.

42. The apparatus of claim 41 wherein the matrix comprises a multiplicity of cells and a culture medium for nourishing and sustaining the cells.

43. The apparatus of claim 42 wherein the multiplicity of cells comprise autologous or donor spleen cells that secrete complex proteins that inhibit an auto-immune response causing diabetes.

44. The apparatus of claim 41 wherein the matrix comprises a bioabsorbable material that elutes or secretes complex proteins that inhibit an auto-immune response causing diabetes.

45. The apparatus of claim 42 wherein the matrix comprises a multiplicity of autologous or donor pancreatic islets that secrete insulin and a culture medium for nourishing and sustaining the multiplicity of cells.

46. The apparatus of claim 41 wherein the matrix comprises a biocompatible culture medium capable of replacing renal tubular cells and filtering blood.

47. The apparatus of claim 41 further comprising a delivery sheath having proximal and distal ends, and a lumen extending therebetween, the anchor adapted for disposition within the lumen in the delivery configuration.

48. The apparatus of claim 47 further comprising an advancement device disposed within the delivery sheath lumen and extending proximal of a proximal end of the delivery sheath, the advancement device configured to expand the anchor from the delivery configuration to the deployed configuration.

49. The apparatus of claim 41 further comprising a retriever disposed within the delivery sheath lumen and extending proximal of a proximal end of the delivery sheath, the retriever configured to collapse the anchor from the deployed configuration to the delivery configuration.

50. The apparatus of claim 41, wherein the anchor is coated or impregnated with a drug chosen from the group consisting of thrombolytics, anticoagulants, antiplatelet medications and antibiotics.

51. The apparatus of claim 48, wherein the advancement device is coupled to the proximal end of the anchor and the anchor is collapsible back to the delivery configuration.

52. The apparatus of claim 41, wherein the anchor comprises a resiliently expandable cage.

53. The apparatus of claim 41, wherein the anchor comprises a pair of resilient expandable legs.

54. The apparatus of claim 41, wherein the anchor comprises three or more resilient expandable legs.

55. The apparatus of claim 41 wherein the anchor includes a plurality of struts joined at the proximal and distal ends by bioabsorbable beads, the bioabsorbable beads comprising a material that dissolves after a predetermined time to permit the plurality of struts to reconfigure.

56. The apparatus of claim 41, wherein one or more sensors are embedded within the matrix.

57. The apparatus of claim 56, wherein the sensors are used to measure physiological and biochemical properties in the blood stream, and then transmit the information concerning the physiological and biochemical properties to a receiving device.