METHODS AND APPARATUS FOR CAPTURING EMBOLIC DEBRIS DURING ENDOVASCULAR PROCEDURES

• US 20140163603A1
• Filed: 12/11/2012
• Published: 06/12/2014
• Est. Priority Date: 12/11/2012
• Status: Active Grant

• Current Assignee: Alan Zajarias
• Original Assignee: Alan Zajarias
• Inventors: Zajarias, Alan
• Granted Patent: US 10,307,240 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2230/0067 conical

Abstract

Methods and apparatus for use in capturing embolic debris during a surgical procedure in a patient are provided. The methods include utilizing an embolic capture device that is configured for delivery into a patient via a transapical delivery approach and via an arterial delivery approach, and determining which of a transapical delivery approach and an arterial delivery approach should be used with the patient. The methods also include inserting the embolic capture device within a delivery system, and deploying the embolic capture device at a desired location within the patient'"'"'s blood vessel that is downstream from the location of the surgical procedure. The same embolic capture device is configured for use with a transapical delivery approach and an arterial, such as a transfermoral, delivery approach.

Claims

1. A method of capturing embolic debris during a surgical procedure in a patient, said method comprising:

utilizing an embolic capture device that is configured for delivery into a patient via a transapical delivery approach and via an arterial delivery approach;

determining which of a transapical delivery approach and an arterial delivery approach should be used with the patient;

inserting the embolic capture device within a delivery system; and

deploying the embolic capture device at a desired location within the patient'"'"'s blood vessel that is downstream from the location of the surgical procedure.

2. A method in accordance with claim 1 wherein deploying the embolic capture device at a desired location further comprises releasing the embolic capture device from the delivery system such that the embolic capture device self-expands within the blood vessel.

3. A method in accordance with claim 1 wherein deploying the embolic capture device at a desired location further comprises positioning the embolic capture device within the blood vessel such that the embolic capture device self-expands and extends across substantially the whole cross-section of the blood vessel at the desired location.

4. A method in accordance with claim 1 wherein deploying the embolic capture device at a desired location further comprises positioning the embolic capture device within the blood vessel such that the embolic capture device substantially circumferentially contacts an inner wall of the blood vessel when deployed.

5. A method in accordance with claim 1 further comprising filtering blood flow downstream from the location of the surgical procedure using the embolic capture device and without occluding the blood flow.

6. A method in accordance with claim 1 further comprising filtering blood flow downstream from the location of the surgical procedure using the embolic capture device and without inflating any components within the blood vessel.

7. A method in accordance with claim 1 further comprising filtering blood flow downstream from the location of the surgical procedure using the embolic capture device and without cardiopulmonary bypass.

8. A method in accordance with claim 1 deploying the embolic capture device at a desired location further comprises releasing the embolic capture device from the delivery system such that the embolic capture device self-expands within the blood vessel and is substantially self-centered within the blood vessel.

9. A method in accordance with claim 1 further comprising deploying at least one of a surgical instrument and a surgical tool to the surgical procedure location by selectively moving the at least one of the surgical instrument and the surgical component through the embolic capture device while the embolic capture device is deployed within the blood vessel.

10. A method in accordance with claim 1 wherein the surgical procedure involves replacing a valve within a patient, said method further comprises delivering the replacement valve to the surgical procedure location by moving the replacement valve through the embolic capture device while the embolic capture device is deployed within the blood vessel.

11. A method in accordance with claim 1 further comprising selectively collapsing the embolic capture device to enable the filter to be removed from the patient without losing any debris captured while the embolic capture device was deployed in the blood vessel.

12. A method in accordance with claim 1 further comprising selectively aspirating the embolic capture device while the device is within the patient'"'"'s blood vessel.

13. An embolic protection system comprising:

a filter for use in capturing embolic debris entrained within a patient'"'"'s blood flow in a blood vessel; and

a filter delivery system configured to contain said filter therein for delivery to a desired surgical location within a patient, said delivery system configured to deliver said filter to the desired location within the patient via a transapical approach, said filter delivery system is further configured to deliver said filter to the desired surgical location via an arterial approach through the patient, said filter configured to filter blood flow within the patient without cardiopulmonary bypass.

14. An embolic protection system in accordance with claim 13 wherein said filter delivery system further comprises a sheath and a deployment tool, at least a portion of said deployment tool is slidably coupled within at least a portion of said sheath.

15. An embolic protection system in accordance with claim 13 wherein said sheath extends circumferentially about said deployment tool and said filter when said filter is being at least one of delivered to the desired surgical location and retrieved from the desired surgical location.

16. An embolic protection system in accordance with claim 13 wherein said sheath comprises a side port that facilitates selective aspiration of said filter when said filter is contained within sheath.

17. An embolic protection system in accordance with claim 13 wherein said filter is self-expanding when deployed.

18. An embolic protection system in accordance with claim 13 wherein said filter is self-centering within the blood vessel when deployed.

19. An embolic protection system in accordance with claim 13 wherein said filter is selectively moveable from a collapsed state to an expanded state.

20. An embolic protection system in accordance with claim 13 wherein said deployment tool is configured to:

selectively release said filter from said sheath when said filter is at the desired location; and

selectively reposition said filter within said sheath.

21. An embolic protection system in accordance with claim 13 wherein said delivery system is configured to enable at least one of tools and surgical components to selectively deploy to the desired surgical location by moving the at least one of tools and surgical components through said filter.

22. A filter for use in capturing embolic debris entrained in a blood vessel, said filter comprising:

an inlet end comprising a first mechanism for use inselectively positioning said filter within a blood vessel;

a capture end comprising a second mechanism for use in selectively positioning said filter within a blood vessel;

a body extending between said inlet end and said capture end, said body comprising a plurality of pores sized to capture embolic debris entrained in blood flowing through said filter, said filter is configured for deployment through a delivery system to the blood vessel via an arterial route, said filter is further configured for deployment through a delivery system to the blood vessel via a tranapical route, said filter is selectively moveable from an expanded state in which said inlet end is substantially circular and has a larger diameter than a diameter of said capture end, to a collapsed state wherein said inlet end is non-circular and said inlet end diameter is approximately the same as said capture end diameter, said filter body is biased towards its expanded state.