Method and apparatus for treating vulnerable plaque

• US 20060265043A1
• Filed: 03/24/2006
• Published: 11/23/2006
• Est. Priority Date: 09/30/2002
• Status: Abandoned Application

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Michal, Eugene T., Chiu, Jessica G., Chow, Mina, Mandrusov, Evgenia, Claude, Charles D., Webler, William E., Kilpatrick, Deborah, Simhambhatla, Murthy, Hossainy, Syed Faiyez Ahmed
• Application Number:
  US11/388,355
• Publication Number:
  US 20060265043A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/86 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: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 2025/107 having a longitudinal slit in the balloon
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Various apparatuses and methods are described to treat vulnerable plaque with the use of combination drug therapy. In one embodiment, the apparatus has an elongated catheter body adapted for insertion in a body lumen, with a drug delivery device attached near a distal portion of the elongated body. The drug delivery device is configured to deliver a therapeutic or biologically active agent to stabilize a vulnerable plaque. In another embodiment, a drug eluting stent is delivered and deployed in conjunction with a second apparatus that delivers drug in pressurized retrograde perfusion. Still another embodiment uses a uniquely shaped balloon to deploy a stent while utilizing a drug infusion needle to inject drug into the vessel wall through a hollow guide wire.

Claims

1. A method to treat an arterial region comprising:

advancing percutaneously a drug eluting stent system into an arterial vessel to a target site;

inflating a balloon on the drug eluting stent system to deliver a drug eluting stent coated with a first drug at the target site;

advancing percutaneously a retrograde perfusion delivery catheter system to a venous region distal to the coronary artery from a venous vessel;

inflating a second balloon on the retrograde perfusion delivery catheter to occlude the venous vessel;

perfusing with pressure in retrograde a second drug from the retrograde perfusion delivery catheter from a venous region into capillaries; and

bathing the second drug in the capillaries as the retrograde pressure forces the second drug into the capillaries and tissue surrounding the arterial region.

2. The method as in claim 1 wherein the arterial region is a diseased coronary artery with a vulnerable plaque lesion.

3. The method as in claim 2 wherein the drug eluting stent contains a drug comprising at least one drug selected from the group consisting of sirolimus, everolimus, paclitaxel, anti-restenotic agents, anti-inflammatory agents, and anti-proliferative agents.

4. The method as in claim 1 wherein the drug eluting stent system comprises a drug delivery port to deliver at least one of a drug solution and a plaque stabilizing agent.

5. The method as in claim 1 wherein the second drug is different from the first drug on the drug eluting stent, and wherein said second drug is complementary to or augments the effectiveness of the first drug on the drug eluting stent.

6. The method of claim 1 wherein said second drug comprises at least one of a drug selected from the group consisting of a small molecule drug, peptide or gene construct in solution, a controlled release microsphere formulation, a liposome formulation, a second drug formulation and a therapeutic agent.

7. The method as in claim 1 wherein the second balloon on the retrograde perfusion delivery catheter is a compliant balloon that will not injure the venous vessel.

8. An apparatus comprising:

a percutaneous retrograde perfusion drug delivery catheter to treat a vulnerable plaque lesion in a diseased arterial region from a venous system in conjunction with a catheter with an inflatable balloon inflated proximal to the vulnerable plaque lesion, the percutaneous retrograde perfusion drug delivery catheter having three lumens with a first lumen for inflation of a balloon, a second lumen for passing of a guidewire, and a third lumen for pressurized retrograde delivery of a drug from the venous system in a direction of the arterial region.

9. The apparatus as in claim 8 wherein the perfusion drug delivery catheter further comprises a drug eluting stent system and the inflatable balloon is inflated after delivering said drug eluting stent at or near the vulnerable plaque lesion in the diseased arterial region.

10. The apparatus as in claim 9 wherein the drug eluting stent is coated with one or more of a second drug selected from a group consisting of sirolimus, everolimus, paclitaxel, anti-restenotic agents, anti-proliferative agents, and anti-inflammatory agents.

11. The apparatus as in claim 10 wherein the first drug comprises a therapeutic agent having a formulation that is different from the second drug coated onto a drug eluting stent, wherein said first drug is complementary to or augments effectiveness of the second drug.

12. The apparatus as in claim 9 wherein the diseased arterial region also comprises diffuse disease and a discrete lesion.

13. The apparatus as in claim 12 wherein the apparatus is used to treat the arterial region from a venous vessel by way of pressurized retrograde perfusion to bathe the first drug into capillaries and tissue surrounding the diseased arterial region.

14. The apparatus as in claim 8 wherein the first drug comprises at least one of a drug selected from the group consisting of small molecule drugs, peptide constructs in a solution, gene constructs in a solution, controlled release microsphere formulations and liposome formulations.

15. The apparatus as in claim 8 wherein the catheter system is delivered into a coronary venous vessel downstream of a target coronary arterial region and a coronary capillary bed in relation to normal blood flow.

16. The apparatus of claim 15 wherein said coronary venous vessel is the coronary sinus.

17. The apparatus as in claim 15 wherein the pressurized retrograde delivery infuses the first drug from the coronary sinus into the coronary capillary bed and myocardial tissue surrounding the target coronary arterial region.

18. The apparatus as in claim 8 wherein the apparatus is used in conjunction with a drug delivery device other than a drug eluting stent.

19. The apparatus of claim 18 wherein said drug delivery device is a balloon catheter incorporating a needle for drug delivery and a molded balloon inflatable catheter using a flexible and retractable needle in a modified or hollowed guide wire for drug delivery.

20. The apparatus of claim 19 wherein said balloon contains a groove along the balloon region for receiving said guide wire.

21. An apparatus comprising:

a percutaneous drug eluting stent coated with a first drug, wherein said stent is mounted over a catheter delivery system with a flexible needle that can be manually advanced from the catheter along a proximal balloon shoulder into a vessel wall at an angle for injection of a second drug when the balloon is inflated after the drug eluting stent is deployed.

22. The apparatus as in claim 21 wherein the first drug comprises at least one of a drug selected from the group consisting of sirolimus, everolimus, paclitaxel, anti-restenotic agents, anti-inflammatory agents and anti-proliferative agents.

23. The apparatus as in claim 22 wherein the second drug comprises a formulation that is different from the first drug, wherein said second drug is complementary to or augments effectiveness of the first drug.

24. The apparatus as in claim 21 wherein the catheter delivery system is advanced into a diseased coronary artery comprising at least one of discrete lesions, diffusion lesions and vulnerable plaque.

25. The apparatus as in claim 21 wherein the needle is pre-shaped and emerges from the catheter delivery system in a curved fashion to puncture the vessel wall.

26. The apparatus of claim 25 wherein the needle comprises a hollow center.

27. The apparatus of claim 25 wherein the needle is made of a shape memory alloy or polymer.

28. The apparatus as in claim 25 wherein the needle only enters the vessel wall at an angle similar to that of the shoulder of the balloon relative to the vessel wall after the balloon is inflated.

29. The apparatus as in claim 28 wherein the needle is advanced into a range of depths of a coronary artery ranging from the internal elastic lamina to the periadventitial space depending on the drug to be delivered and the state of the diseased artery.

30. The apparatus as in claim 21 wherein the catheter delivery system can be used to simultaneously deploy the drug eluting stent and infuse the second drug in a coronary artery.

31. The apparatus as in claim 21 wherein the catheter delivery system is used to first deploy the drug eluting stent and then deflate the balloon to advance the catheter delivery system along different positions of a coronary artery for multiple infusions of the second drug.

32. The apparatus as in claim 21 wherein the second drug is injected into the periadventitial space of a coronary artery and migrates through a fat layer to bathe the epicardium and other coronary arteries.

33. A method to treat a vessel with a vulnerable plaque comprising:

advancing percutaneously a drug eluting stent to a target site in the vessel, wherein said drug eluting stent is coated with a first drug, and wherein said drug eluting stent is mounted on a needle catheter system;

inflating a balloon on the needle catheter system to deploy the drug eluting stent;

advancing a flexible needle inside a lumen along a shoulder of the inflated balloon;

extracting the flexible needle from an exit port on the shoulder of the inflated balloon into the vessel wall;

injecting a second drug into the vessel wall; and

bathing the second drug in the vessel wall for absorption by the vessel.

34. The method as in claim 33 wherein the first drug on the drug eluting stent comprises at least one of a drug selected from the group consisting of sirolimus, everolimus, paclitaxel, anti-restenotic agents, anti-inflammatory agents and anti-proliferative agents.

35. The method as in claim 33 wherein the second drug comprises a formulation that is different from the first drug on the drug eluting stent, wherein said second drug is complementary to or augments effectiveness of the first drug.

36. The method as in claim 33 wherein the vessel with a vulnerable plaque is a coronary artery with discrete lesions or diffuse disease.

37. The method as in claim 33 wherein the needle is flexible and pre-shaped and emerges from the catheter delivery system in a curved fashion to puncture the vessel wall.

38. The method of claim 37 wherein the needle comprises a hollow center.

39. The method of claim 37 wherein the needle is made of a shape memory alloy or polymer.

40. The method as in claim 37 wherein the needle only enters the vessel wall at an angle similar to that of the shoulder of the balloon relative to the vessel wall after the balloon is inflated.

41. The method as in claim 40 wherein the needle is advanced into a range of depths in a coronary artery ranging from the internal elastic lamina to the periadventitial space depending on the drug to be delivered and state of the disease.

42. The method as in claim 33 wherein the second drug is injected into the periadventitial space of a coronary artery and migrates through a fat layer to bathe the epicardium and other coronary arteries.

43. The method as in claim 33 wherein the catheter delivery system can be used to first deploy the drug eluting stent and then deflate the balloon to advance the catheter delivery system along different positions of a coronary artery for multiple infusions of the second drug.

53. The apparatus as in claim 36 wherein the stent catheter delivery system is used to first deploy the drug eluting stent, and then deflate the balloon to advance the catheter delivery system along different positions of a coronary artery to delivery drug using the delivery guide wire.

44. An apparatus comprising:

a guidewire having a hollow center, said guidewire comprising a retractable, flexible needle to inject a first drug to treat a vessel with a vulnerable plaque; and

a stent catheter system comprising a drug eluting stent coated with a second drug and a balloon molded with an external groove or trench on an outer profile along a length of the balloon, wherein said stent is mounted on said balloon and wherein said groove or trench provides free guidewire movement along the balloon and allows free needle access to a vessel wall from the guidewire after the balloon is inflated against the vessel wall.

45. The apparatus as in claim 44 wherein the second drug comprises at least one of a drug selected from the group consisting of sirolimus, everolimus, paclitaxel, anti-restenotic agents, anti-inflammatory agents and anti-proliferative agents.

46. The apparatus as in claim 45 wherein the first drug comprises a therapeutic agent having a formulation that is different from the second drug on the drug eluting stent, wherein said first drug is complementary to or augments effectiveness of the second drug in treatment of the vessel.

47. The apparatus as in claim 44 wherein the vessel is a diseased coronary artery with discrete lesions and/or diffuse disease.

48. The apparatus as in claim 44 wherein the needle is pre-shaped and emerges from the catheter delivery system in a curved fashion to puncture the vessel wall.

49. The apparatus as in claim 48 wherein the needle comprises a hollow center.

50. The apparatus of claim 48 wherein the needle is made of a shape memory alloy or polymer.

51. The apparatus as in claim 48 wherein the needle is advanced into a range of depths in a coronary artery ranging from internal elastic lamina to periadventitial space depending on the drug to be delivered and disease state of the coronary artery.

52. The apparatus as in claim 44 wherein the catheter delivery system is used to simultaneously deploy the drug eluting stent and infuse the first drug.

54. The apparatus as in claim 44 wherein once the drug to be delivered is injected into a periadventitial space of a coronary artery, the drug will migrate through a fat layer to bathe the epicardium and other coronary arteries.

55. A method to treat a vessel comprising:

advancing percutaneously a stent catheter system to a vessel with a vulnerable plaque said catheter system comprising a drug eluting stent coated with a first drug and a balloon molded with an external groove or trench on an outer profile along a length of the balloon, wherein said stent is mounted on said balloon;

inflating the balloon to deploy the drug eluting stent against the vessel wall;

positioning a needle exit port on a guidewire at a selected region against the vessel wall along the external groove of the balloon;

advancing a flexible and retractable needle inside the guidewire out of the needle exit port;

penetrating the flexible needle into the vessel wall;

injecting a second drug into the vessel wall; and

bathing the second drug in the vessel wall for absorption by the vessel.

56. The method as in claim 55 wherein a first drug on the drug eluting stent comprises at least one of a drug selected from the group consisting of sirolimus, everolimus, paclitaxel, anti-restenotic agents, anti-inflammatory agents and anti-proliferative agents.

57. The method as in claim 56 wherein the second drug comprises a formulation that is different from the first drug, wherein said second drug is complementary to or augments the first drug in treating vulnerable plaque.

58. The method as in claim 55 wherein the catheter delivery system is advanced into a diseased coronary artery with discrete lesions and/or diffusion lesions.

59. The method as in claim 55 wherein the needle is flexible and pre-shaped and emerges from the catheter delivery system in a curved fashion to puncture the vessel wall.

60. The method of claim 59 wherein the needle comprises a hollow center.

61. The method of claim 59 wherein the needle is made of a shape memory alloy or polymer.

62. The method as in claim 59 wherein the needle is advanced into a range of depths in a coronary ranging from the internal elastic lamina to the periadventitial space depending on the second drug to be delivered and disease state of the artery.

63. The method as in claim 55 wherein the second drug is injected into the periadventitial space in a coronary artery and migrates through a fat layer to bathe the epicardium and other coronary arteries.

64. The method to treat a diseased vessel comprising:

deploying a drug eluting stent at a target site in the diseased vessel with a vulnerable plaque, wherein said stent is coated with a first drug;

delivering an infusate to circulate downstream of the target site;

bathing a vessel region with the infusate to allow for diffusion into the vasculature;

wherein the overall therapeutic effect on the diseased vessel is augmented by the combination therapy provided by the first drug and the complementary effects of the infusate acting within the vasculature via diffusion.

65. The method as in claim 64 wherein the diseased vessel comprises a diseased artery that includes a vulnerable plaque.

66. The method as in claim 64 wherein the first drug comprises at least one of a drug selected from the group consisting of sirolimus, everolimus, paclitaxel, anti-proliferative agents, anti-inflammatory agents, and anti-restenotic agents.

67. The method as in claim 64 wherein the infusate comprises a carrier fluid together with nanoparticles such as liposomes.

68. The method as in claim 67 wherein the infusate parameters are optimized according to the disease state based on at least one of vulnerable plaque, diffused diseases and discrete lesion found in the vessel.

69. The method as in claim 67 wherein the infusate parameters are optimized by selecting one or more of a mixed population of drugs, nanoparticle size distribution, bulk property of the nanoparticle, surface chemistry of the nanoparticle, host-material response property of the nanoparticles, and Theological property of the carrier.

70. The method as in claim 64 wherein the bathing of a vessel region is accomplished by retrograde perfusion or access into a pericardial sac.

71. The method as in claim 64 wherein the infusate comprises a second drug comprising at least one of a solution or a controlled release suspension to address the vessel disease.

72. The method as in claim 71 wherein the solution or the controlled release suspension has at least one agent selected from a group consisting of proteins, peptides and genes encapsulated in particles.

73. The method as in claim 71 wherein the solution or the controlled release suspension contains an agent selected from a group consisting of liposomes, statins, anti-inflammatory agents, e-NOS regulators, and oxidant signal antagonists.