MINIMAL SURFACE AREA CONTACT DEVICE FOR HOLDING PLAQUE TO BLOOD VESSEL WALL

• US 20110004237A1
• Filed: 05/29/2010
• Published: 01/06/2011
• 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: Giasolli, Robert, SCHNEIDER, Peter
• Granted Patent: US 10,188,533 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• 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 focal elevating elements on its outer annular periphery for holding loose plaque under a spring or other expansion force against a blood vessel wall. The focal elevating elements are designed to exert a holding force on a plaque position while minimizing the amount of material surface area in contact with the plaque or blood vessel wall and reducing the potential of friction with the intraluminal surface. This approach offers clinicians the ability to perform a minimally invasive post-angioplasty treatment and produce a stent-like result without using a stent.

Claims

1. A device for holding plaque against a blood vessel wall in treating atherosclerotic occlusive disease, comprising:

a thin, annular band of durable, flexible material having a plurality of focal elevating elements on its outer annular periphery, said focal elevating elements each having a contact surface dimension of contact with the blood vessel wall where it is to be placed that is equal to or less than a width of an adjoining strut of said annular band on which it is supported, said focal elevating elements being configured to reduce regional areas of contact of the device with the blood vessel wall, said annular band being dimensioned and designed to apply point pressure and elevate adjoining struts forming the thin annular band of the device off from contact with the blood vessel wall.

2. A device according to claim 1, wherein the focal elevating elements have regionally lifted sections that are configured to reduce pressure in regions neighboring the focal elevating elements in order to minimize trauma due to contact or movement between the device and the blood vessel wall.

3. A device according to claim 1, wherein the focal elevating elements reduce effective metal interface (EMI) by minimizing the overall material contact with the blood vessel surface.

4. A device according to claim 1, wherein the focal elevating elements are placed at locations of the tack device and have a size and orientation so as to change the point pressure distribution of outward forces of the focal elevating elements in order to generate a desired arterial cross section such as a circle or ellipse.

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 device according to claim 1, wherein said annular band has a length in the axial direction of the blood vessel wall that is about equal to or less than its diameter.

12. A device according to claim 1, wherein the annular band is in a ring or ribbon shape, and the ratio of width of the band strut to band diameter is in the range of 1/10 to 1/100.

13. A method according to claim 5, wherein a series of spaced-apart tack devices are applied over the axial length of a blood vessel treatment site.

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

15. A device according to claim 5, 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 device according to claim 5, wherein the tack device is formed with concentric rings spaced apart coaxially from each other and connected by longitudinally extending bridge members.

17. A device 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 device according to claim 1, adapted for use after balloon angioplasty when there is damage, disruption, dissection, or irregularity to the blood vessel surface caused by the balloon angioplasty treatment, the tack device is configured to tack down the damaged, disrupted, dissected, or irregular blood vessel surface.

19. A device according to claim 1, wherein the tack device is configured to elute or deliver plaque treatment medication to the blood vessel.

20. A device according to claim 1, wherein the tack device is configured to be applied with an expansion force against the plaque in the blood vessel including by balloon expansion.