SYSTEM AND METHOD TO LIMIT CEREBRAL ISCHEMIA

• US 20150119977A1
• Filed: 10/27/2014
• Published: 04/30/2015
• Est. Priority Date: 10/30/2013
• Status: Abandoned Application

• Current Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Original Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Parodi, Juan, Berguer, Ramon
• Application Number:
  US14/524,711
• Publication Number:
  US 20150119977A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/006 modular

Abstract

A system to limit cerebral ischemia occurring as a consequence of aortic valve replacement includes an aortic valve having proximal and distal ends, a sleeve having proximal and distal ends, the proximal end of the sleeve disposed at the distal end of the aortic valve, and a filter attached to the distal end of the sleeve to receive blood and particles passing from the proximal end of the sleeve to the distal end of the sleeve and to separate the particles from the blood. A related method includes introducing a system into a heart of a patient, the system comprising an aortic valve having proximal and distal ends and a sleeve having a proximal end disposed at the distal end of the valve, implanting the valve in an aortic valve annulus, and filtering blood that has passed through the valve into the sleeve.

Claims

1. A system to limit cerebral ischemia occurring as a consequence of aortic valve replacement, the system comprising:

an aortic valve having a proximal end and a distal end;

a sleeve having a proximal end and a distal end, the proximal end of the sleeve disposed at the distal end of the aortic valve; and

a filter attached to the distal end of the sleeve to receive blood and particles passing from the proximal end of the sleeve to the distal end of the sleeve and to separate the particles from the blood.

2. The system according to claim 1, further comprising a cannula connected to the filter to return blood from the filter to the patient.

3. The system according to claim 1, further comprising a removable fastener that attaches the proximal end of the sleeve to the distal end of the valve.

4. The system according to claim 3, wherein the removable fastener comprises at least one suture that attaches the proximal end of the sleeve to the distal end of the valve.

5. The system according to claim 4, wherein the removable fastener comprises at least one flexible release mechanism having a proximal end attached to the at least one suture and a distal end.

6. The system according to claim 5, wherein the at least one flexible release mechanism is an extension of the at least one suture.

7. The system according to claim 5, wherein the removable fastener comprises at least one cannula fixedly attached to the sleeve,

the at least one cannula having proximal and distal ends,

the at least one flexible release mechanism disposed within the at least one cannula, and

the at least one flexible release mechanism including a stop disposed between the proximal and distal ends of the at least one flexible release mechanism and the at least one cannula including at least one restriction disposed between the proximal and distal ends, the stop abutting the restriction to limit the relative movement of the release mechanism to the cannula and the attached sleeve.

8. The system according to claim 2, wherein the valve comprises a stent having at least one open cell and the removable fastener comprises at least one wire having a proximal end cooperating with the at least one open cell to attach the fastener to the stent and a distal end.

9. The system according to claim 8, wherein the stent includes wire-like structural elements that define the at least one open cell, the proximal end of the wire disposed through the at least one open cell and about the wire-like structural elements.

10. The system according to claim 1, further comprising a delivery sheath, the valve and at least a portion of the sleeve disposed within the delivery sheath prior to implantation of the valve.

11. The system according to claim 1, wherein the filter is capable of removing particles 120 μ

m and larger.

12. The system according to claim 1, wherein the valve comprises a stent and an animal valve disposed within the stent.

13. A method of limiting cerebral ischemia occurring as a consequence of aortic valve replacement, the method comprising:

introducing a system into a heart of a patient, the system comprising an aortic valve having a proximal end and a distal end and a sleeve having a proximal end disposed at the distal end of the valve;

implanting the valve in an aortic valve annulus; and

filtering blood that has passed through the valve into the sleeve.

14. The method according to claim 13, further comprising rapid pacing the heart of the patient prior to introducing the system and interrupting rapid pacing prior to filtering blood that has passes through the valve into the sleeve.

15. The method according to claim 13, wherein filtering blood that has passed through the valve into the sleeve comprises filtering blood that has passed through the valve into the sleeve for 5 to 10 heart beats.

16. The method according to claim 13, further comprising returning blood that has passed through the valve into the sleeve after filtering the blood that has passed through the valve into the sleeve.

17. The method according to claim 13, further comprising detaching the sleeve from the valve.

18. The method according to claim 17, wherein detaching the sleeve from the valve comprises removing one or more sutures attaching the sleeve to the valve.

19. The method according to claim 17, wherein detaching the sleeve from the valve comprises removing one or more wires attaching the sleeve to the valve.

20. A filter assembly for trapping debris caused by implantation of an artificial aortic valve, comprising:

a sleeve having a proximal end and a distal end, the proximal end of the sleeve being connectable to a self-expanding stent frame of a valve, the sleeve tapering from a first diameter at the proximal end thereof, the first diameter equaling a diameter of a distal end of the valve, inwardly to a second diameter in a direction toward the distal end of the sleeve;

the valve having a proximal end and a distal end, the valve including a valve region comprising an organic biocompatible material with a distal end defining a scalloped skirt, and the self-expanding stent frame attached to the valve region, the stent frame defined by a framework of wire-like structural elements defining a plurality of open cells.