Extended protection embolic filter

• US 8,968,354 B2
• Filed: 10/24/2012
• Issued: 03/03/2015
• Est. Priority Date: 10/26/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Wang, Huisun, Anderson, James M.
• Primary Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US13/659,051
• Publication Number:
  US 20130110153A1
• Time in Patent Office: 860 Days
• Field of Search: 606/151, 606/153, 606/154, 606/155, 606/156, 606/200, 623/1.13, 623/1.15, 623/1.23
• US Class Current: 606/200
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

The disclosure pertains to porous embolic debris diverters comprising a porous diverter element, a support structure therefor, and a non-hollow flexible elongated retrieval element fixedly attached thereto. The disclosure further pertains to delivery systems for the embolic debris diverters comprising a pusher and an elongated sheath as well as methods of use for the porous embolic debris diverters and the delivery systems therefor. The porous embolic debris diverters are adapted to remain within the body for extended periods of time.

Claims

1. An embolic protection device comprising:

a porous diverter element having a distal opening;

a support structure connected to the distal opening of the porous diverter element; and

a non-hollow flexible elongated retrieval element having a distal end and a proximal end, wherein the distal end is fixedly affixed to at least one of the porous diverter element and the support structure and the proximal end is adapted to remain outside of the body,

further wherein the embolic protection device has a first compressed state and a second expanded deployed state wherein the distal opening of the porous diverter element does not form a closed loop, and wherein the support structure includes a partial loop supporting the distal opening of the porous diverter element.

2. The embolic protection device of claim 1, wherein the non-hollow flexible elongated retrieval element fixedly affixed to at least one of the porous diverter element and the support structure is a suture.

3. The embolic protection device of claim 1, further wherein the porous diverter element has a proximal opening.

4. The embolic protection device of claim 1, wherein the partial loop of the support structure supporting the distal opening of the porous diverter element is sized and adapted to subtend between 180 degrees and 359 degrees of the circumference of a vessel in which it is deployed.

5. The embolic protection device of claim 1, wherein the embolic protection device has a first delivery configuration in which a portion of the non-hollow flexible elongated retrieval element is wrapped around the porous diverter element thereby maintaining the embolic protection device in the first compressed state and a second deployed configuration in which the non-hollow flexible elongated retrieval element has been unwrapped from around the porous diverter element allowing the embolic protection device to assume the second expanded deployed state within the body.

6. The embolic protection device of claim 1, wherein at least one of the porous diverter element and the support structure further comprises a tubular portion having a lumen adapted to slidably receive a guidewire.

7. An embolic protection device delivery system comprising:

the embolic protection device of claim 1 and

a pusher having a distal end and a proximal end,

wherein the distal end of the pusher is adapted to engage a proximal end of at least one of the porous diverter element and the support structure when the embolic protection device in the first compressed state.

8. The embolic protection device delivery system of claim 7, further wherein the pusher distal end includes an extension which at least partially surrounds the proximal end of at least one of the porous diverter element and the support structure when the embolic protection device in the first compressed state.

9. The embolic protection device delivery system of claim 7, further comprising an elongated sheath having a lumen with a distal end and a proximal end,

wherein the distal end of said lumen is adapted to slidably receive the pusher and the proximal end of at least one of the porous diverter element and the support structure when the embolic protection device in the first compressed state.

10. The embolic protection device delivery system of claim 9, wherein the proximal end of the lumen of the elongated sheath is adapted to slidably receive the pusher and the non-hollow flexible elongated retrieval element of the embolic protection device.

11. The embolic protection device delivery system of claim 9, wherein the sheath is adapted to be removed from the non-hollow flexible elongated retrieval element of the embolic protection device when the embolic protection device is in the second expanded deployed state.

12. The embolic protection device delivery system of claim 7, wherein the pusher further includes a lumen adapted to slidably receive the non-hollow flexible elongated retrieval element of the embolic protection device.

13. The embolic protection device delivery system of claim 12, wherein the pusher lumen adapted to slidably receive the non-hollow flexible elongated retrieval element of the embolic protection device extends from the distal end to the proximal end of the pusher.

14. The embolic protection device delivery system of claim 12, wherein the pusher is adapted to be removed from the non-hollow flexible elongated retrieval element of the embolic protection device when the embolic protection device is in the second expanded deployed state.

15. A method of preventing debris from entering a carotid artery for an extended period of time comprising:

disposing an embolic protection device of claim 1 in a first compressed state and a pusher having a distal end and a proximal end within a lumen of an elongated sheath,

wherein the distal end of the pusher is adapted to engage a proximal end of at least one of the porous diverter element and the support structure when the embolic protection device in a first compressed state,

wherein the non-hollow flexible elongated retrieval element of the embolic protection device extends from proximate the distal end of the pusher through the lumen of the sheath and exits the proximal end of the sheath;

advancing the embolic protection device in a first compressed state, the pusher, and the elongated sheath through a vessel to a position proximate a deployment site;

advancing the pusher distally within the lumen of the elongated sheath, thereby ejecting the embolic protection device in a first compressed state thereby allowing the embolic protection device to assume a second deployed state;

withdrawing the sheath from the vessel;

withdrawing the pusher from the vessel;

waiting a specified period of time;

inserting a retrieval device for the embolic protection device along the non-hollow flexible elongated retrieval element of the embolic protection device to a point proximate the proximal end of the embolic protection device;

withdrawing the non-hollow flexible elongated retrieval element of the embolic protection device relative to the retrieval device until the embolic protection device is at least partially contained within the retrieval device; and

withdrawing the embolic protection device, the non-hollow flexible elongated retrieval element, and the retrieval device from the vessel.

16. The method of claim 15, wherein the step of advancing the embolic protection device of claim 1 in a first compressed state, the pusher, and the elongated sheath through a vessel comprises advancing the embolic protection device in a first compressed state, the pusher, and the elongated sheath through a left subclavian artery to an aorta.