Methods and apparatus for capturing embolic debris during endovascular procedures

• US 10,307,240 B2
• Filed: 12/11/2012
• Issued: 06/04/2019
• Est. Priority Date: 12/11/2012
• Status: Active Grant

• Current Assignee: Alan Zajarias
• Original Assignee: Alan Zajarias
• Inventors: Zajarias, Alan
• Primary Examiner(s): Severson, Ryan J.
• Assistant Examiner(s): Knauss, Christian D
• Application Number:
  US13/710,676
• Publication Number:
  US 20140163603A1
• Time in Patent Office: 2,366 Days
• Field of Search: 606200
• 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. An embolic protection system for use in capturing embolic debris entrained within blood flowing along a blood vessel of a patient at a desired location that is downstream of a location at which an endovascular procedure is to be performed using a surgical component, said embolic protection system comprising:

a filter having a first end and a second end, wherein said second defines an inlet opening and said first end defines an access opening;

a filter delivery system coupled to said filter for delivery of said filter along the blood vessel to the desired location via an arterial approach, wherein said filter delivery system comprises;

a sheath comprising a hollow sheath body that extends from an open sheath proximal end to an open sheath distal end and defines an internal sheath cavity therebetween, said open sheath ends and said internal sheath cavity defined by an inner surface of said sheath body and having a same, substantially constant inner diameter, wherein said sheath body extends continuously between said open sheath ends; and

a hollow deployment tool comprising a hollow tool body that extends from a tool proximal end to an open tool distal end, wherein an outer surface of said deployment tool is slidably coupled to said inner surface of said sheath body such that a seal is defined therebetween, said deployment tool defining an internal tool cavity that extends from said tool distal end to said tool proximal end, said open tool distal end coupled to said filter first end; and

a control mechanism coupled to said deployment tool proximal end, said control mechanism substantially prevents blood from exiting said tool cavity at said proximal end of said deployment tool, wherein when said filter is deployed at the desired location in the patient, (i) said filter second end defines a distal-most location of said embolic protection system, and (ii) said embolic protection system is adapted to pass the surgical component therethrough through said control mechanism, through said tool proximal end, through said sheath proximal end, through said sheath distal end, through said open tool distal end, and through said filter via said access opening and said inlet opening upstream to the location of the endovascular procedure.

2. An embolic protection system in accordance with claim 1 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 location and retrieved from the desired location.

3. An embolic protection system in accordance with claim 1 wherein said hollow deployment tool further comprises a port that facilitates selective aspiration of said filter.

4. An embolic protection system in accordance with claim 1 wherein said filter is self-expanding when deployed.

5. An embolic protection system in accordance with claim 1 wherein said filter is self-centering within the blood vessel when deployed.

6. An embolic protection system in accordance with claim 1 wherein said filter is selectively moveable from a collapsed state to an expanded state.

7. An embolic protection system in accordance with claim 1 wherein said deployment tool is slidable within said sheath to:

selectively release said filter from said sheath; and

selectively reposition said filter within said sheath.

8. An embolic protection system in accordance with claim 1 wherein said filter is removable from the blood vessel after the endovascular procedure.

9. A method of capturing embolic debris entrained within blood flowing along a blood vessel, said method comprising:

delivering a filter along the blood vessel to a desired filter location via an arterial approach using a filter delivery system, the filter having a first end and a second end, wherein the second end defines an inlet opening and the first end defines an access opening, and wherein the filter delivery system includes;

a sheath including a hollow sheath body that extends from an open sheath proximal end to an open sheath distal end and defines an internal sheath cavity therebetween, the open sheath ends and the internal sheath cavity defined by an inner surface of the sheath body and having a same, substantially constant inner diameter, wherein the sheath body extends continuously between the open sheath ends,

a hollow deployment tool comprising a hollow tool body that extends from a tool proximal end to an open tool distal end, wherein an outer surface of the deployment tool is slidably coupled to the inner surface of the sheath body such that a seal is defined therebetween, the deployment tool defining an internal tool cavity that extends from the tool distal end to the tool proximal end, the open tool distal end coupled to the filter first end, and

a control mechanism coupled to the deployment tool proximal end, wherein the control mechanism substantially prevents blood from exiting the cavity at the proximal end of the deployment tool;

deploying the filter at the desired filter location in the patient such that the filter second end defines a distal-most location of the filter delivery system; and

passing a surgical component through the control mechanism, through the tool proximal end, through the sheath proximal end, through the sheath distal end, through the open tool distal end, and through the filter via the access opening and the inlet opening upstream to a location of an endovascular procedure to be performed using the surgical component.

10. A method in accordance with claim 9, further comprising retaining the filter within a circumferential extent of the deployment tool during the step of delivering the filter.

11. A method in accordance with claim 9, further comprising selectively aspirating the filter via a port defined in the hollow deployment tool.

12. A method in accordance with claim 9, wherein the step of deploying the filter comprises allowing the filter to self-expand.

13. A method in accordance with claim 9, wherein the step of deploying the filter comprises allowing the filter to self-center within the blood vessel.

14. A method in accordance with claim 9, wherein the step of deploying the filter comprises the filter moving from a collapsed state to an expanded state.

15. A method in accordance with claim 9, wherein the step of deploying the filter comprises sliding the deployment tool within the sheath to selectively release the filter from the sheath.

16. A method in accordance with claim 9, further comprising sliding the deployment tool within the sheath to selectively reposition the filter within the sheath after the endovascular procedure is completed.

17. A method in accordance with claim 9, further comprising removing the filter from the blood vessel after the endovascular procedure.