Method and apparatus for treating vulnerable plaque

• US 8,652,194 B1
• Filed: 03/23/2006
• Issued: 02/18/2014
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kilpatrick, Deborah, Simhambhatla, Murthy, Prabhu, Santosh, Quee, Shawn Chin
• Primary Examiner(s): Houston, Elizabeth
• Application Number:
  US11/388,899
• Time in Patent Office: 2,889 Days
• Field of Search: 623 111- 113, 623 142- 148, 128/898, 424/423, 424/185.1
• US Class Current: 623/1.13
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 27/3808 Endothelial cells
• CPC Class Codes: A61L 27/3843 Connective tissue
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0086 the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An apparatus and method to treat vulnerable plaque. In one embodiment, the apparatus has a medical device to treat an occlusive plaque, and is also adapted to release a biologically active agent to treat vulnerable plaque located downstream from the occlusive plaque. In an alternative embodiment, the apparatus has an expandable tube attached to the inner surface of a stent, and a layer of endothelial cells seeded on the inner surface of the expandable tube. The expandable tube shields a vulnerable plaque from a body lumen.

Claims

1. A method for treating an arterial lumen, comprising:

detecting a presence of an occlusive plaque and a nearby vulnerable plaque within a same arterial lumen region, wherein the vulnerable plaque is disposed downstream from the occlusive plaque;

expanding a stent graft against the occlusive plaque, the stent graft comprising a self-expanding stent, a non-hydrophilic expandable layer, and a vulnerable plaque stabilizing agent coating on an inner surface of the expandable layer, wherein the expandable layer is coupled directly to an inner surface of the self-expanding stent, and wherein the vulnerable plaque stabilizing agent coating is releasably dispersed on the inner surface of the expandable layer; and

delivering a therapeutically effective amount of the vulnerable plaque stabilizing agent coating downstream to the nearby vulnerable plaque from the expandable layer when the vulnerable plaque stabilizing agent coating becomes exposed to blood flowing in the same arterial lumen region, wherein the therapeutically effective amount of the vulnerable plaque stabilizing agent coating remains within the same arterial lumen region during delivery.

2. The method of claim 1, wherein the vulnerable plaque stabilizing agent coating promotes smooth muscle cell proliferation.

3. The method of claim 1, wherein the expanding the stent graft further comprises controlling a release of the vulnerable plaque stabilizing agent coating over a period up to about eight weeks.

4. The method of claim 1, wherein the delivering the therapeutically effective amount of the vulnerable plaque stabilizing agent coating comprises adhering a plurality of micro-particles to a lumen wall near the vulnerable plaque.

5. The method of claim 1, wherein treating the arterial lumen further comprises reducing a lipid core size of the vulnerable plaque.

6. The method of claim 1, wherein a plurality of endothelial cells is seeded within the non-hydrophilic expandable layer.

7. A method for stabilizing a vulnerable plaque, comprising:

advancing a stent graft within an arterial lumen region, the stent graft comprising a self-expanding stent, a non-hydrophilic expandable layer, and a vulnerable plaque stabilizing agent coating on an inner surface of the expandable layer, wherein the expandable layer is coupled directly to an inner surface of the self-expanding stent, and wherein the vulnerable plaque stabilizing agent coating is releasably dispersed on the inner surface of the expandable layer;

expanding the stent graft in the arterial lumen region against an occlusive plaque upstream from a nearby vulnerable plaque within the same arterial lumen region; and

delivering a therapeutically effective amount of the vulnerable plaque stabilizing agent coating from the expandable layer to the vulnerable plaque disposed downstream from the stent graft to stabilize the vulnerable plaque when the vulnerable plaque stabilizing agent coating becomes exposed to blood flowing in the same arterial lumen region, wherein the therapeutically effective amount of the vulnerable plaque stabilizing agent coating remains within the same arterial lumen region during delivery.

8. The method of claim 7, wherein the vulnerable plaque stabilizing agent coating is exposed to the bloodstream during the stent graft expansion.

9. The method of claim 7, wherein stabilizing the vulnerable plaque further comprises thickening a fibrous cap of the vulnerable plaque.

10. The method of claim 7, wherein stabilizing the vulnerable plaque further comprises reducing a lipid core size of the vulnerable plaque.

11. The method of claim 7, wherein stabilizing the vulnerable plaque further comprises altering a distribution of a lipid core of the vulnerable plaque.

12. The method of claim 7, wherein stabilizing the vulnerable plaque further comprises altering a consistency of a lipid core of the vulnerable plaque.

13. The method of claim 7, wherein a plurality of endothelial cells is seeded within the non-hydrophilic expandable layer.

14. A method for stabilizing a vulnerable plaque, comprising:

detecting a presence of an occlusive plaque located within an arterial lumen region;

detecting a presence of a nearby vulnerable plaque located downstream from the occlusive plaque within the same arterial lumen region;

selecting, in response to detecting the presence of both the occlusive plaque and the vulnerable plaque in the same arterial lumen region, a stent graft comprising a self-expanding stent, a non-hydrophilic expandable layer, and a vulnerable plaque stabilizing agent coating on an inner surface of the expandable layer, wherein the expandable layer is coupled directly to an inner surface of the self-expanding stent, and wherein the vulnerable plaque stabilizing agent coating is releasably dispersed on the inner surface of the expandable layer;

expanding the stent graft against the occlusive plaque; and

delivering a therapeutically effective amount of the vulnerable plaque stabilizing agent coating downstream to the nearby vulnerable plaque from the expandable layer when the vulnerable plaque stabilizing agent coating becomes exposed to blood flowing in the same arterial lumen region, wherein the therapeutically effective amount of vulnerable plaque stabilizing agent coating delivered to the vulnerable plaque remains within the same arterial lumen region during delivery.

15. The method of claim 14, wherein the vulnerable plaque stabilizing agent coating is selected from the group consisting of cytokines and growth factors.

16. The method of claim 15, wherein the vulnerable plaque stabilizing agent coating promotes smooth muscle cell proliferation.

17. The method of claim 14, wherein the delivering further comprises controlling a release of the vulnerable plaque stabilizing agent coating.

18. The method of claim 17, wherein controlling comprises releasing the vulnerable plaque stabilizing agent coating over a period up to about eight weeks.

19. The method of claim 14, wherein delivering the therapeutically effective amount of the vulnerable plaque stabilizing agent coating comprises adhering a plurality of micro-particles to a lumen wall near the vulnerable plaque.

20. The method of claim 14, wherein stabilizing the vulnerable plaque comprises reducing a lipid core size of the vulnerable plaque.

21. The method of claim 14, wherein a plurality of endothelial cells is seeded within the non-hydrophilic expandable layer.