Vessel occlusion device and method of using same

• US 9,642,691 B2
• Filed: 04/02/2015
• Issued: 05/09/2017
• Est. Priority Date: 10/17/2002
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Vonesh, Michael J.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US14/677,734
• Publication Number:
  US 20150209132A1
• Time in Patent Office: 768 Days
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: B23P 11/00 Connecting or disconnecting metal parts or objects by metal-working techniques not otherwise provided for connecting sheet metal or metal tubes, rods or profiles B21D39/00; riveting B21J; soldering, unsoldering, welding B23K; hand tools for connecting wire or strip B25B25/00; connecting metal parts by adhesives F16B11/00
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An improved embolic filter frame is provided. The filter frame provides enhanced longitudinal compliance, improved sealing, low profile delivery, and short deployed length. The looped support struts have high “radial” stiffness with low “longitudinal” stiffness. When deployed, the frame exerts a relatively high stress onto a vessel wall to maintain an effective seal, yet remains longitudinally compliant. Minor displacements of the support wire or catheter are therefore not translated to the filter. The looped support struts elongate when tensioned and assume a compressed and essentially linear form. When the delivery catheter constraint is removed, the struts “snap open” and assume a looped configuration, exerting a high degree of force onto the vessel wall, creating an enhanced filter to vessel wall seal.

Claims

1. A vessel occluder device comprising:

an occluder element; and

a frame, the frame comprising;

a collar, the collar disposed about a longitudinal axis of the vessel occluder device, the collar disposed at a proximal end of the frame;

an occluder element support portion defining a region disposed about the longitudinal axis, wherein the occluder element is attached to the occluder element support portion such that the occluder element is configured to substantially prevent fluid from flowing through the vessel occluder device; and

multiple support struts that each extend from the collar to respective proximal apices of the occluder element support portion,

wherein the collar, the occluder element support portion, and the multiple support struts are formed from a single piece of precursor material including a tube of shape memory material cut to form a single ring that defines the collar and a plurality of strut elements extending from the single ring to define the support struts, the tube being thermally treated to define an initial, tapered configuration.

2. The vessel occluder device of claim 1, wherein the precursor material comprises a tubular form.

3. The vessel occluder device of claim 2, wherein the tubular form comprises nitinol.

4. The vessel occluder device of claim 1, wherein the precursor material comprises a sheet material.

5. The vessel occluder device of claim 4, wherein the sheet material comprises nitinol.

6. The vessel occluder device of claim 1, wherein the vessel occluder device has a collapsed delivery profile and an expanded deployment profile.

7. The vessel occluder device of claim 6, wherein the vessel occluder device self-expands to reconfigure from the collapsed delivery profile to the expanded deployment profile.

8. The vessel occluder device of claim 1, wherein at least one support strut of the multiple support struts has at least one portion with a bend equal to or greater than 90 degrees while the frame is configured in an expanded deployment profile, and wherein the at least one portion with the bend equal to or greater than 90 degrees is unattached to the occluder element.

9. The vessel occluder device of claim 1, wherein each support strut of the multiple support struts has at least one portion with a bend equal to or greater than 90 degrees while the frame is configured in an expanded deployment profile, and wherein the at least one portion with the bend equal to or greater than 90 degrees is unattached to the occluder element.

10. The vessel occluder device of claim 1, wherein the frame includes multiple diamond shaped cells.

11. The vessel occluder device of claim 1, wherein a distal end portion of the occluder element support portion includes multiple distal apices that define multiple distal scallops of the vessel occluder device.

12. The vessel occluder device of claim 1, wherein the vessel occluder device has a generally circular end view profile while the frame is configured in an expanded deployment profile.

13. The vessel occluder device of claim 1, wherein the occluder element comprises a sheet material.

14. The vessel occluder device of claim 13, wherein the sheet material comprises ePTFE.

15. The vessel occluder device of claim 1, wherein the collar is coupleable to a wire.

16. A method of occluding a vessel, the method comprising:

delivering a vessel occluder device that is configured in a constrained configuration within a lumen of a delivery device to a target location within the vessel, wherein the vessel occluder device comprises;

an occluder element; and

a frame comprising;

a collar, the collar disposed about a longitudinal axis of the vessel occluder device, the collar disposed at a proximal end of the frame;

an occluder element support portion defining a region disposed about the longitudinal axis, wherein the occluder element is attached to the occluder element support portion; and

multiple support struts that each extend from the collar to respective proximal apices of the occluder element support portion,

wherein the collar, the occluder element support portion, and the multiple support struts are formed from a single piece of precursor material including a tube of shape memory material cut to form a single ring that defines the collar and a plurality of strut elements extending from the single, ring to define the support struts, the tube being thermally treated to define an initial, tapered configuration; and

deploying the vessel occluder device out of the lumen of the delivery device to the target location within the vessel, wherein the vessel occluder device self-expands to a deployed configuration such that an outer periphery of the vessel occluder device is in contact with a wall of the vessel, and such that the occluder element substantially prevents fluid within the vessel from flowing through the vessel occluder device.

17. The method of claim 16, wherein at least one support strut of the multiple support struts has at least one portion with a bend equal to or greater than 90 degrees while the frame is configured in the deployed configuration, wherein the at least one portion with the bend equal to or greater than 90 degrees is unattached to the occluder element, and wherein the at least one portion with the bend equal to or greater than 90 degrees enhances a radial force imparted against the wall of the vessel for improved sealing of the vessel occluder device against the wall of the vessel.

18. The method of claim 16, wherein a distal end portion of the occluder element support portion includes multiple distal apices that define multiple distal scallops of the vessel occluder device.

19. The method of claim 16, wherein, while the frame is configured in the deployed configuration, a distal end portion of the occluder element support portion has a smaller outer diameter than another more proximal portion of the occluder element support portion.

20. The method of claim 16, wherein a support wire is releasably coupled to the collar, wherein the deploying the vessel occluder device out of the lumen comprises distally translating the support wire in relation to the lumen, and

wherein the method further comprises, after the deploying the vessel occluder device out of the lumen, decoupling the support wire from the collar.

21. A method of occluding a vessel, the method comprising:

delivering a vessel occluder device that is configured in a constrained configuration within a lumen of a delivery device to a target location within the vessel, wherein the vessel occluder device includes,

an occluder element, and

a frame including,

a collar disposed about a longitudinal axis of the vessel occluder device at a proximal end of the frame,

a support wire releasably coupled to the collar,

an occluder element support portion defining a region disposed about the longitudinal axis, wherein the occluder element is attached to the occluder element support portion, and

multiple support struts that each extend from the collar to respective proximal apices of the occluder element support portion,

wherein the collar, the occluder element support portion, and the multiple support struts are formed from a single piece of precursor material;

deploying the vessel occluder device out of the lumen of the delivery device to the target location within the vessel including distally translating the support wire in relation to the lumen, wherein the vessel occluder device self-expands to a deployed configuration such that an outer periphery of the vessel occluder device is in contact with a wall of the vessel, and such that the occluder element substantially prevents fluid within the vessel from flowing through the vessel occluder device, wherein the deploying the vessel occluder device out of the lumen; and

decoupling the support wire from the collar after deploying the vessel occluder device out of the lumen.