Method of treating atherosclerotic occlusive disease

• US 9,974,670 B2
• Filed: 09/27/2011
• Issued: 05/22/2018
• Est. Priority Date: 12/12/2007
• Status: Active Grant

• Current Assignee: Intact Vascular, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Intact Vascular, Inc. (Koninklijke Philips N.V.)
• Inventors: Schneider, Peter, Giasolli, Robert
• Primary Examiner(s): Severson, Ryan J
• Assistant Examiner(s): Knauss, Christian
• Application Number:
  US13/246,776
• Publication Number:
  US 20120083872A1
• Time in Patent Office: 2,429 Days
• Field of Search: 623 111, 623 114, 623 116, 623 136, 623 142, 606 7
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 : stapled
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A tack device for holding plaque against blood vessel walls in treating atherosclerotic occlusive disease can be formed as a thin, annular band of durable, flexible material. The tack device may also have a plurality of barbs or anchoring points on its outer annular periphery. The annular band can have a length in the axial direction of the blood vessel walls that is about equal to or less than its diameter as installed in the blood vessel. A preferred method is to perform angioplasty with a drug eluting balloon as a first step, and if there is any dissection to the blood vessel caused by the balloon angioplasty, one or more tack devices may be installed to tack down the dissected area of the blood vessel surface, in order to avoid the need to install a stent and thereby maintain a ‘stent-free’ environment.

Claims

1. A method of treating atherosclerotic occlusive disease in a blood vessel comprising:

positioning a guide wire across a blockage or narrowing in the blood vessel;

advancing a drug eluting balloon (DEB) over the guide wire to the blockage or narrowing in the blood vessel;

inflating and then deflating the DEB at the blockage or narrowing in the blood vessel thereby creating an expanded area of the blood vessel, inflating further comprising creating a dissection in a blood vessel surface;

removing the DEB from the blood vessel;

advancing a delivery catheter loaded with multiple self-expanding Nitinol tacks to the treatment area;

independently deploying two or more self-expanding Nitinol tacks from the delivery catheter at the discretion of an operator to treat the dissection in the blood vessel surface creating a treatment area, such that a vessel coverage area (C) of the deployed two or more self-expanding Nitinol tacks divided by a Total Vessel Surface Area (TVS) of the treatment area has a ratio (C/TVS) of less than or equal to 60%, wherein the vessel coverage area is based on summation of an axial length measured from a distal-most end to a proximal-most end for each of the deployed two or more self-expanding Nitinol tacks, and the Total Vessel Surface Area is based on a distance from a distal-most end to a proximal-most end of the treatment area having the dissection in the blood vessel surface;

positioning a balloon at the site of the deployed two or more self-expanding Nitinol tacks; and

inflating the balloon to further expand the deployed two or more self-expanding Nitinol tacks into a wall of the blood vessel.

2. The method of claim 1, wherein deploying two or more self-expanding Nitinol tacks from the delivery catheter further comprises deploying the two or more self-expanding Nitinol tacks such that the ratio (C/TVS) is less than or equal to 50%.

3. The method of claim 1, wherein deploying two or more self-expanding Nitinol tacks from the delivery catheter further comprises deploying each tack such that they do not overlap with any adjacent tack.

4. The method of claim 1, wherein deploying two or more self-expanding Nitinol tacks from the delivery catheter further comprises deploying each self-expanding Nitinol tack at least one tack axial length apart from any adjacent self-expanding Nitinol tack.

5. The method of claim 1, further comprising delivering medication to the blood vessel with one or more of the deployed two or more self-expanding Nitinol tacks.

6. The method of claim 1, wherein a ratio of axial length to a diameter (L/D) for each self-expanding Nitinol tack is equal to or less than 1.

7. The method of claim 1, further comprising engaging the wall of the blood vessel with a barb or anchor on each of the deployed two or more self-expanding Nitinol tacks to maintain a locking relationship between the tack and the wall.

8. The method of claim 7, wherein engaging the wall of the blood vessel further comprises piercing the wall with the barb or anchor.

9. The method of claim 1, wherein a spacing of the tacks in the vessel is different than a spacing of the tacks in the delivery catheter.

10. The method of claim 1, wherein each self-expanding Nitinol tack comprises concentric rings connected by a series of bridging members and deploying two or more self-expanding Nitinol tacks from the delivery catheter further comprises self-expanding the concentric rings.

11. A method of treating a blood vessel comprising:

advancing a first balloon to a blockage or narrowing in the blood vessel;

inflating and then deflating the first balloon at the blockage or narrowing in the blood vessel thereby creating an expanded area, the expanded area further having a treatment area defined by a dissection in the blood vessel surface;

removing the first balloon from the blood vessel;

advancing a delivery catheter including multiple independently deployable implants to the treatment area; and

deploying two or more implants from the delivery catheter to treat the dissection in the blood vessel surface at the treatment area, such that a vessel coverage area (C) of the deployed two or more implants divided by a Total Vessel Surface Area (TVS) of the treatment area has a ratio (C/TVS) of less than or equal to 60%, wherein the vessel coverage area is based on summation of an axial length measured from a distal-most end to a proximal-most end for each of the deployed two or more implants, and the Total Vessel Surface Area is based on a distance from a distal-most end to a proximal-most end of the treatment area having the dissection in the blood vessel surface.

12. The method of claim 11, wherein deploying two or more implants from the delivery catheter further comprises deploying the two or more implants such that the ratio (C/TVS) is less than or equal to 50%.

13. The method of claim 11, wherein deploying two or more implants from the delivery catheter further comprises deploying each implant of the two or more implants such that they do not overlap with any adjacent implant of the two or more implants.

14. The method of claim 11, wherein deploying two or more implants from the delivery catheter further comprises deploying each implant at least one implant axial length apart from any adjacent implant.

15. The method of claim 11, wherein deploying two or more implants from the delivery catheter further comprises releasing two or more self-expanding Nitinol implants from the delivery catheter and allowing the two or more self-expanding Nitinol implants to self-expand.

16. The method of claim 11, further comprising delivering medication to the blood vessel with one or more of the deployed two or more implants.

17. The method of claim 11, wherein advancing a first balloon to the blockage or narrowing in the blood vessel further comprises advancing a drug eluting balloon to the blockage or narrowing in the blood vessel.

18. The method of claim 11, further comprising positioning a second balloon at the treatment site and inflating the second balloon to further expand the deployed two or more implants.

19. The method of claim 11, wherein deploying two or more implants from the delivery catheter further comprises releasing two or more polymer implants.

20. The method of claim 19, wherein deploying two or more implants from the delivery catheter further comprises releasing two or more polymer implants from the delivery catheter and allowing the two or more polymer implants to self-expand.

21. The method of claim 19, wherein deploying two or more implants from the delivery catheter further comprises releasing at least one polymer implant consisting of polyglycolic acid from the delivery catheter.

22. The method of claim 11, wherein a ratio of the axial length to a diameter (L/D) for each implant is equal to or less than 1.

23. The method of claim 11, further comprising engaging tissue of the blood vessel with a barb or anchor on each of the deployed two or more implants.

24. The method of claim 23, wherein engaging tissue of the blood vessel further comprises piercing the tissue with the barb or anchor.

25. The method of claim 11, wherein a spacing of the implants in the blood vessel is different than a spacing of the implants in the delivery catheter.

26. The method of claim 11, wherein each implant comprises concentric rings connected by a series of bridging members and deploying two or more implants from the delivery catheter further comprises expanding the concentric rings.

27. A method of treating a blood vessel comprising:

advancing a balloon to a blockage in the blood vessel;

inflating and then deflating the balloon at the blockage in the blood vessel thereby creating one or more dissections in a surface of the blood vessel;

removing the first balloon from the blood vessel;

advancing a delivery catheter having multiple implants to the one or more dissections in the surface of the blood vessel; and

independently deploying two or more implants from the delivery catheter to treat a single dissection of the one or more dissections, such that a vessel coverage area (C) of the deployed two or more implants divided by a Total Vessel Surface Area (TVS) of the single dissection has a ratio (C/TVS) of less than or equal to 60%, wherein the vessel coverage area is based on summation of an axial length measured from a distal-most end to a proximal-most end for each of the deployed two or more implants, and the Total Vessel Surface Area is based on a distance from a distal-most end to a proximal-most end of the single dissection.

28. The method of claim 27, wherein deploying two or more implants from the delivery catheter further comprises deploying the two or more implants such that the ratio (C/TVS) is less than or equal to 50%.

29. The method of claim 27, wherein deploying two or more implants from the delivery catheter further comprises deploying each implant of the two or more implants such that they do not overlap with any adjacent implant.

30. The method of claim 27, wherein deploying two or more implants from the delivery catheter further comprises deploying each implant of the two or more implants at least one implant axial length apart from any adjacent implant.