Methods and apparatus for treating embolism

Patent metadata

Field	Value
Publication number	US-9408620-B2
Application number	US-201514602014-A
Country	US
Kind code	B2
Filing date	Jan 21, 2015
Priority date	Nov 20, 2012
Publication date	Aug 9, 2016
Grant date	Aug 9, 2016

Abstract

A method and apparatus for treating a clot in the blood vessel of a patient, and particularly the treatment of a pulmonary embolism is disclosed. The treatment includes restoring flow through the clot followed by clot removal, either partially or substantially completely. The clot treatment device is expandable into the blood vessel and may contain radial extensions that assist in restoring flow as well as in removing clot material.

First claim

We claim:

1. A method of treating a pulmonary embolism that at least partially restricts blood flow through a pulmonary vessel, the method comprising:
delivering an embolectomy device at least partially through the pulmonary embolism, wherein the embolectomy device includes an expandable braided structure;
deploying the braided structure within at least a portion of the pulmonary embolism, wherein deploying the braided structure includes withdrawing a delivery sheath such that the braided structure expands and forms a flow channel that restores blood flow through the pulmonary embolism and wherein, in a deployed state, the braided structure has an expandable cylindrical portion positioned between a first portion and a second portion that individually extend radially outwardly from the cylindrical portion such that a surface area to length ratio of the individual first and second portions is greater than the surface area to length ratio of the cylindrical portion;
moving the embolectomy device and at least a portion of the pulmonary embolism along the pulmonary vessel; and
withdrawing the embolectomy device and at least a portion of the pulmonary embolism from the pulmonary vessel.

2. The method of claim 1 wherein deploying the braided structure includes expanding at least one of the first and second portions distal to the pulmonary embolism.

3. The method of claim 1 wherein deploying the braided structure comprises expanding the braided structure such that a combined surface area of the cylindrical portion, first portion, and the second portion is within a range of at least two times to four times the surface area of a uniformly cylindrical device having a diameter that is the same as that of the cylindrical portion and a length that is the same as the combined length of the first, second, and third portions.

4. The method of claim 1 , further comprising applying vacuum while withdrawing the embolectomy device.

5. The method of claim 1 wherein, in a deployed state, the cylindrical portion has a length in a longitudinal direction and each of the first and second portions have a length in the longitudinal direction that is less than the length of the cylindrical portion.

6. The method of claim 1 wherein the braided structure is self-expanding.

7. The method of claim 1 wherein withdrawing the braided structure includes elongating the braided structure.

8. The method of claim 1 wherein deploying the braided structure includes expanding the cylindrical portion such that a diameter of the cylindrical portion increases by a ratio of at least 4:1 to 8:1.

9. The method of claim 1 wherein the first and second portions are disc-shaped.

10. The method of claim 1 wherein deploying the clot treatment device includes urging an outer surface of the cylindrical portion against an inner surface of the pulmonary embolism to form a channel having a longitudinal length that is between about 4 mm to about 8 mm.

11. The method of claim 1 wherein deploying the braided structure reduces a mean resting pulmonary artery pressure within a range of about 20-50 mmHg.

12. A method of treating a pulmonary embolism at a treatment site within a pulmonary vessel, the method comprising:
delivering a catheter to the treatment site such that at least a portion of the catheter is positioned within the pulmonary embolism;
delivering a clot treatment device in a delivery state through the catheter to the treatment site and into at least a portion of the pulmonary embolism, wherein, in a deployed state, the clot treatment device includes a first portion, a second portion, and a third portion between the first and second portions;
expanding the third portion from a delivery state to a deployed state;
expanding the first and second portions from a delivery state to a deployed state, wherein, in the deployed state, the first and second portions have a diameter that is greater than a diameter of the third portion in the deployed state, and wherein the third portion has a length in a longitudinal direction and each of the first and second portions have a length in the longitudinal direction that is less than the length of the third portion;
engaging at least a portion of the pulmonary embolism with the clot treatment device to secure the pulmonary embolism to the clot treatment device; and
withdrawing the clot treatment device, captured pulmonary embolism, and catheter simultaneously from the treatment site.

13. The method of claim 12 wherein the catheter is a first catheter, and wherein the method further comprises drawing the clot treatment device, the first catheter, and the captured pulmonary embolism into a second catheter.

14. The method of claim 12 wherein expanding the first and second portions includes expanding at least one of the first and second portions distal to the pulmonary embolism.

15. The method of claim 12 wherein delivering the catheter includes delivering the catheter such that a distal terminus of the catheter is located distal to a distal portion of the pulmonary embolism.

16. The method of claim 12 , further comprising applying vacuum while withdrawing the clot treatment device.

17. The method of claim 12 wherein expanding the clot treatment device includes expanding the first, second, and third portions such that a combined surface area of the first, second, and third portions expands within a range of at least two times to four times the surface area of a uniformly cylindrical device having a diameter that is the same as that of the third portion and a length that is the same as the combined length of the first, second, and third portions.

18. The method of claim 12 wherein expanding the third portion includes the urging an outer surface of the third portion against an inner surface of the pulmonary embolism to form a channel having a longitudinal length that is between about 4 mm to about 8 mm.

19. The method of claim 12 wherein expanding the third portion includes increasing the blood flow rate through the pulmonary embolism by at least about 50 mL/min.

20. The method of claim 12 wherein the first, second, and third portions are self-expanding.

Assignees

• Inceptus Medical LLC
• Inari Medical Inc

Inventors

• Rosenbluth Robert F
• Cox Brian J
• Lubock Paul

Classifications

• A61B2017/320716

  comprising means for preventing embolism by dislodged material · CPC title

• A61B2017/22094

  for crossing total occlusions, i.e. piercing · CPC title

• A61B2017/00862

  elastic or resilient · CPC title

• A61B2017/22038

  with a guide wire · CPC title

• A61B2017/22081

  Treatment of vulnerable plaque · CPC title