Vascular device and method for valve leaflet apposition

• US 9,737,305 B2
• Filed: 10/23/2015
• Issued: 08/22/2017
• 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:
  US14/922,062
• Publication Number:
  US 20160038146A1
• Time in Patent Office: 669 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 method for treating venous valve insufficiency comprising the steps of:

inserting a delivery device and a vascular device having a plurality of legs into a target vessel adjacent valve leaflets of the vessel;

deploying the vascular device from the delivery device to move a proximal portion of the legs radially outwardly to engage a wall of the vessel; and

subsequently releasing a distal portion of the legs to move the proximal portion of the legs radially inwardly to move the vessel wall radially inwardly and bring the valve leaflets closer together;

wherein the proximal portion of the legs have vessel penetrating members, and wherein in an expanded placement position of the vascular device, the vessel penetrating members are spaced from a center longitudinal axis of the vascular device a radial distance less than a radial distance distal portions of the legs are spaced from the center longitudinal axis; and

prior to releasing the distal portion of the legs, the vessel penetrating members are spaced from the center longitudinal axis a radial distance greater than a radial distance distal tips of the legs are spaced from the center longitudinal axis.

2. The method of claim 1, wherein the step of releasing the distal portion of the legs includes moving a retention member of the vascular device axially, the retention member deployable from the delivery device.

3. The method of claim 1, wherein the step of releasing the distal portion of the legs enables the vascular device to return to a shape memorized position.

4. The method of claim 1, further comprising the step of pulling a retention member proximally to move the legs proximally into contact with the delivery device, the delivery device camming the legs further outwardly.

5. The method of claim 1, wherein the delivery device is inserted to a position upstream of the valve leaflets to deliver the vascular device upstream of the valve leaflets.

6. The method of claim 1, wherein the delivery device is inserted to a position downstream of the valve leaflets to deliver the vascular device downstream of the valve leaflets.

7. The method of claim 1, wherein the vascular device is inserted through the saphenous vein or the popliteal vein to a position downstream of the valve leaflets.

8. The method of claim 1, wherein the vascular device is inserted through the saphenous vein or the popliteal vein to a position upstream of the valve leaflets.

9. The method of claim 1, wherein the device is substantially conical in configuration.

10. The method 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.

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

12. The method of claim 1, wherein the device includes a retention member retaining the distal portion of the legs and the step of releasing a distal portion of the legs includes the step of releasing the retention member into the vessel.

13. The method of claim 1, wherein the device has free ends at the proximal portion and distal portion.

14. The method of claim 1, wherein release of the legs causes distal tips of the legs to diverge radially outwardly.

15. A method for treating venous valve insufficiency comprising the steps of:

inserting a delivery device and a vascular device having a plurality of legs into a target vessel adjacent valve leaflets of the vessel;

deploying the vascular device from the delivery device to move a proximal portion of the legs radially outwardly to engage a wall of the vessel; and

subsequently releasing a distal portion of the legs to move the proximal portion of the legs radially inwardly to move the vessel wall radially inwardly and bring the valve leaflets closer together, wherein the step of releasing the distal portion of the legs releases the legs from a converged position, the proximal portion of the legs are normally angled inwardly as the distal portion of the legs are normally angled outwardly.

16. The method of claim 15, wherein release of the legs causes distal tips of the legs to diverge radially outwardly.

17. The method of claim 16, wherein the device has free ends at the proximal portion and distal portion.

18. A method for treating venous valve insufficiency comprising the steps of:

inserting a delivery device and a vascular device having a plurality of legs into a target vessel adjacent valve leaflets of the vessel;

deploying the vascular device from the delivery device to move a proximal portion of the legs radially outwardly to engage a wall of the vessel;

subsequently releasing a distal portion of the legs to move the proximal portion of the legs radially inwardly to move the vessel wall radially inwardly and bring the valve leaflets closer together, wherein the step of releasing the distal portion of the legs includes moving a retention member of the vascular device axially, wherein the retention member is distal of the proximal portion of the legs and remains distal during release of the distal portion of the legs.