DEVICE AND METHOD FOR TACKING PLAQUE TO A BLOOD VESSEL WALL

• US 20100262225A1
• Filed: 06/11/2009
• Published: 10/14/2010
• 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
• Granted Patent: US 8,128,677 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• 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 is formed as a thin, annular band of durable, flexible material having a plurality of barbs or anchoring points on its outer annular periphery. The annular band has 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. In a preferred embodiment, the tack device is formed as a compressible metallic mesh band having outer barbs on outer sides of the mesh structure. Another embodiment may have a plurality of compressible mesh bands may be formed spaced apart coaxially from each other and connected by longitudinally extending bridge members. 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 device for holding plaque against blood vessel walls in treating atherosclerotic occlusive disease, comprising:

a thin, annular band of durable, flexible material having a plurality of barbs or anchoring points on its outer annular periphery, said annular band being dimensioned and designed to be applied with an expansion force against the plaque to press and hold the plaque at an applied site of said band against the blood vessel walls.

2. A device according to claim 1, wherein the annular band has 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.

3. A device according to claim 2, wherein the annular band is in a ring or ribbon shape, and the ratio of width of the band to diameter as installed in the blood vessel is in the range of 1/10 to 1/100.

4. A device according to claim 1, formed as a compressible metallic mesh band having outer barbs on outer sides of the mesh structure.

5. A device according to claim 1, comprising a plurality of annular bands that are spaced apart coaxially from each other and applied over an axial length of a blood vessel treatment site.

6. A device according to claim 5, wherein a spacing between adjacent annular bands is at least the width of an annular band.

7. A device according to claim 1, wherein a ratio of Vessel Coverage Area (C) to Total Vessel Surface area (TVS) is in the range of about 60% or less.

8. A device according to claim 1, wherein said device is formed with concentric rings spaced apart coaxially from each other and connected by longitudinally extending bridge members.

9. A device according to claim 8, wherein a measure for Effective Metallic Interface (EMI) of a ratio of vessel coverage area underneath the device (lumen surface) and surface area of metallic members is used for the tack device:

10. A device according to claim 1, wherein said device has a structure for carrying medication such that it elutes a biologically active agent to the plaque when placed in the blood vessel.

11. A method of treating atherosclerotic occlusive disease, comprising:

treating any plaque dissection after balloon angioplasty by installing a tack device formed as a thin, annular band of durable, flexible material having a plurality of barbs or anchoring elements on its outer annular periphery applied with an expansion force to hold the plaque at an applied site of said band against the blood vessel walls.

12. A method according to claim 11, wherein the annular band has 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.

13. A method according to claim 11, wherein a series of spaced-apart tack devices are applied over the axial length of a blood vessel treatment site.

14. A method according to claim 13, wherein a spacing between adjacent annular bands is at least the width of an annular band.

15. A method according to claim 11, wherein a ratio of Vessel Coverage Area (C) to Total Vessel Surface area (TVS) is in the range of about 60% or less.

16. A method according to claim 11, wherein the tack device is formed with concentric rings spaced apart coaxially from each other and connected by longitudinally extending bridge members.

17. A method according to claim 16, wherein a measure for Effective Metallic Interface (EMI) of a ratio of vessel coverage area underneath the device (lumen surface) and surface area of metallic members is used for the tack device:

18. A method according to claim 11, wherein drug eluting balloon angioplasty is performed as a first step, and if there is any damage, disruption, dissection, or irregularity to the blood vessel caused by the balloon angioplasty, one or more tack devices may be used to tack down the damaged, disrupted, dissected, or irregular blood vessel surface.

19. A method according to claim 11, wherein the tack device is used to elute or deliver plaque treatment medication to the blood vessel.

20. A method according to claim 11, wherein the tack device is applied against the plaque in the blood vessel by balloon expansion.