Vascular device and method for valve leaflet apposition

• US 10,159,488 B2
• Filed: 07/28/2017
• Issued: 12/25/2018
• Est. Priority Date: 04/26/2012
• Status: Active Grant

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: Leedle, John D.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Shipmon, Tiffany
• Application Number:
  US15/663,683
• Publication Number:
  US 20170333045A1
• Time in Patent Office: 515 Days
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00796 Breast surgery
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A vascular device having a plurality of struts having a distal portion and a proximal portion. The distal portion of the struts are retained in a converged position. The struts diverge radially outwardly. A plurality of vessel penetrating members extend from the proximal portion of the struts for engaging the internal wall of the vessel, wherein release of the retention of the distal portions of the struts causes the distal portions to move outwardly away from the longitudinal axis and the proximal portions of the struts to move inwardly toward the longitudinal axis such that the vessel engaging members pull the internal wall of the vessel radially inwardly.

Claims

1. A vascular device for minimally invasively treating valve insufficiency within a vessel of a patient, the vascular device comprising a plurality of struts, each strut having a first end portion and a second end portion on an opposing end of the strut from the first end portion, the struts movable from a delivery position to a treatment position, in the delivery position the first end portions of the struts diverge radially outwardly and the second end portions of the struts converge radially inwardly and are retained in a converged position, wherein release of retention of the second end portions of the struts causes the second end portions of the struts to move outwardly away from a central longitudinal axis of the vascular device so the second end portions diverge radially outwardly and the first end portions of the struts move radially inwardly toward the central longitudinal axis such that the first end portions pull an internal wall of the vessel radially inwardly to place the device in the treatment position, in the treatment position the second end portions are a greater radial distance from the central longitudinal axis than the first end portions.

2. The vascular device of claim 1, further comprising a retention member to retain the second end portions in the converged position, the retention member releasable to release the second end portions of the struts from the converged position.

3. The vascular device of claim 2, wherein the device is composed of shape memory material and release of the retention member enables the struts to return to their shape memorized position.

4. The vascular device of claim 2, wherein the retention member is movable axially to release the second end portions from the converged position.

5. The vascular device of claim 2, wherein in the converged position a transverse dimension of the second end portions of the struts is less than a transverse dimension of the first end portions of the struts and after release of the retention member, the transverse dimension of the second end portions of the struts exceeds the transverse dimension of the first end portions of the struts.

6. The vascular device of claim 2, wherein the retention member includes a cap placed over the second end portions.

7. The vascular device of claim 1, wherein in the delivery position the first end portions are a greater radial distance from the central longitudinal axis than the second end portions.

8. The vascular device of claim 1, wherein the struts include a vessel engaging member extending from the first end portion for engaging the internal wall of the vessel.

9. The vascular device of claim 8, wherein the vessel engaging members have penetrating tips.

10. The vascular device of claim 1, wherein the device has connecting struts in an intermediate region of the struts angled between adjacent struts.

11. The vascular device of claim 1, wherein the device is substantially oval in transverse cross-section to form a shorter dimension and a longer dimension and the longer dimension is substantially parallel with a valve commissure.

12. The vascular device of claim 1, further comprising a retention member to retain the second end portions in the converged position, wherein when the retention member is released, the first end portions pivot toward the central longitudinal axis of the device.

13. The vascular device of claim 1, wherein the struts terminate in free ends at the second end portions.

14. The vascular device of claim 1, wherein the struts extend linearly having a longitudinal axis extending from the first end portion to the second end portion.

15. The vascular device of claim 1, wherein the first end portions are unconnected.

16. The vascular device of claim 15, wherein the second end portions in the treatment position are unconnected.

17. The vascular device of claim 1, wherein the second end portions in the treatment position are unconnected.

18. The device of claim 1, wherein the device is formed from a tube and the struts are formed from cutouts in the tube.