Methods and apparatus for treating embolism

• US 9,408,620 B2
• Filed: 01/21/2015
• Issued: 08/09/2016
• Est. Priority Date: 11/20/2012
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: Inari Medical, Inc.
• Inventors: Rosenbluth, Robert F., Cox, Brian J., Lubock, Paul
• Primary Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US14/602,014
• Publication Number:
  US 20160008014A1
• Time in Patent Office: 566 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22081 Treatment of vulnerable plaque
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members

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.

Claims

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.