Method of treating atherosclerotic occlusive disease

• US 10,299,945 B2
• Filed: 05/18/2018
• Issued: 05/28/2019
• 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 D
• Application Number:
  US15/984,111
• Publication Number:
  US 20180303640A1
• Time in Patent Office: 375 Days
• 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 a blood vessel comprising:

advancing a delivery catheter loaded with multiple independently deployable self-expanding tacks to a treatment area including a dissection in the blood vessel surface;

independently deploying two or more self-expanding tacks of the multiple independently deployable self-expanding tacks from the delivery catheter at the discretion of an operator to treat the dissection in the blood vessel surface, such that a vessel coverage area (C) of the deployed two or more self-expanding 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 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.

2. The method of treating a blood vessel of claim 1, wherein deploying two or more self-expanding tacks from the delivery catheter further comprises deploying each self-expanding tack of the two or more self-expanding tacks such that it does not overlap with any adjacent tack of the two or more self-expanding tacks.

3. The method of treating a blood vessel of claim 1, wherein deploying two or more self-expanding tacks from the delivery catheter further comprises deploying each self-expanding tack of the two or more self-expanding tacks spaced apart from any adjacent self-expanding tack of the two or more self-expanding tacks by at least an axial length of a self-expanding tack of the two or more self-expanding tacks.

4. The method of treating a blood vessel of claim 1, wherein a ratio of an axial length to a diameter (L/D) for each self-expanding tack of the multiple independently deployable self-expanding tacks is equal to or less than 1.

5. The method of treating a blood vessel of claim 1, further comprising engaging a wall of the blood vessel with at least one of a barb and an anchor on each of the deployed two or more self-expanding tacks of the multiple independently deployable self-expanding tacks to maintain a locking relationship between each of the deployed two or more self-expanding tacks and the wall of the blood vessel.

6. The method of treating a blood vessel of claim 5, wherein engaging the wall of the blood vessel further comprises piercing the wall of the blood vessel with the at least one of the barb and the anchor.

7. The method of treating a blood vessel of claim 1, wherein a spacing of the deployed two or more self-expanding tacks in the blood vessel is different than a spacing of the multiple independently deployable self-expanding tacks loaded in the delivery catheter.

8. The method of treating a blood vessel of claim 1, wherein each self-expanding tack of the multiple independently deployable self-expanding tacks comprises concentric rings connected by a series of bridging members, and wherein independently deploying two or more self-expanding tacks of the multiple independently deployable self-expanding tacks from the delivery catheter further comprises self-expansion of the concentric rings.

9. The method of treating a blood vessel of claim 1, wherein the treatment area comprises a plurality of dissections in the blood vessel surface, the plurality of dissections including the dissection.

10. A method of treating a blood vessel comprising:

advancing a delivery catheter including multiple independently deployable implants to a treatment area defined by a balloon treatment region including a dissection in the blood vessel surface due to the balloon treatment; and

deploying two or more implants of the multiple independently deployable 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.

11. The method of treating a blood vessel of claim 10, wherein deploying two or more implants from the delivery catheter further comprises deploying each implant of the two or more implants such that it does not overlap with any adjacent implant of the two or more implants.

12. The method of treating a blood vessel of claim 10, wherein deploying two or more implants from the delivery catheter further comprises deploying each implant of the two or more implants spaced apart from any adjacent implant of the two or more implants by at least an axial length of an implant of the two or more implants.

13. The method of treating a blood vessel of claim 10, wherein deploying two or more implants from the delivery catheter further comprises releasing two or more self-expanding implants from the delivery catheter and allowing the two or more self-expanding implants to self-expand.

14. The method of treating a blood vessel of claim 10, further comprising positioning a balloon at the treatment site and inflating the balloon to further expand the deployed two or more implants.

15. The method of treating a blood vessel of claim 10, wherein a ratio of an axial length to a diameter (L/D) for each implant of the multiple independently deployable implants is equal to or less than 1.

16. The method of treating a blood vessel of claim 10, further comprising engaging a tissue of the blood vessel with at least one of a barb and an anchor on each of the deployed two or more implants of the multiple independently deployable implants.

17. The method of treating a blood vessel of claim 10, wherein a spacing of the deployed two or more implants in the blood vessel is different than a spacing of the multiple independently deployable implants included with the delivery catheter.

18. The method of treating a blood vessel of claim 10, wherein the treatment area comprises a plurality of dissections in the blood vessel surface, the plurality of dissections including the dissection.

19. The method of treating a blood vessel of claim 10, wherein the balloon treatment comprises an angioplasy balloon treatment.

20. The method of treating a blood vessel of claim 10, wherein the balloon treatment comprises a drug eluting balloon treatment.