Methods and apparatus for treating embolism

• US 10,004,531 B2
• Filed: 11/20/2013
• Issued: 06/26/2018
• Est. Priority Date: 11/20/2012
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: Inari Medical, Inc.
• Inventors: Rosenbluth, Robert, Cox, Brian J., Lubock, Paul, Quick, Richard
• Primary Examiner(s): Miles, Jonathan
• Application Number:
  US14/646,358
• Publication Number:
  US 20150305756A1
• Time in Patent Office: 1,679 Days
• 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 system for treating a pulmonary embolism, comprising:

an elongated member having a proximal portion and a distal portion; and

a clot treatment device having a proximal portion fixed to the distal portion of the elongated member, the clot treatment device including;

an expandable generally cylindrical portion; and

a plurality of capture elements including at least a first capture element and a second capture element, wherein the generally cylindrical portion is positioned between the first and second capture elements, and wherein the generally cylindrical portion and the capture elements are configured to move from a low-profile undeployed state sized to fit within a delivery catheter to a deployed state in which the generally cylindrical portion has a first cross-sectional dimension greater than that of the low-profile state and the capture elements project outwardly from the generally cylindrical portion,

wherein the generally cylindrical portion has a first longitudinal dimension and each of the capture elements has a second longitudinal dimension, the first longitudinal dimension being greater than the second longitudinal dimension.

2. The system of claim 1 wherein the generally cylindrical portion and the capture elements comprise an expandable braided material that is heat set to have the deployed state.

3. The system of claim 1 wherein the generally cylindrical portion and the capture elements are integrally formed from a common braided material.

4. The system of claim 1, further comprising a plurality of generally cylindrical portions, wherein the capture elements comprise a series of radially extending capture portions, and wherein the radially extending capture portions are separated from each other by individual generally cylindrical portions.

5. The system of claim 4 wherein the generally cylindrical portions comprise expandable cylindrical sections and the capture elements comprise radially expandable disk-like capture portions of braided material.

6. The system of claim 1 wherein the generally cylindrical portion comprises a radially expandable cylindrical braided material and the capture elements comprise protuberances projecting from the generally cylindrical portion.

7. The system of claim 1 wherein the generally cylindrical portion has an expansion ratio from the undeployed state to the deployed state of approximately 1:

4 to 1;

8.

8. The system of claim 1 wherein the generally cylindrical portion has an expansion ratio from the undeployed state to the deployed state of approximately 1:

5 to 1;

7.

9. The system of claim 1 wherein the generally cylindrical portion has a diameter of approximately 4-8 mm in the deployed state to restore blood flow through a pulmonary embolism.

10. The system of claim 1 wherein the generally cylindrical portions and the capture elements comprises a self-expanding braided material, and the capture elements comprise capture portions that have a second diameter greater than the first cross-sectional dimension of the generally cylindrical portions in the deployed state.

11. The system of claim 1 wherein the generally cylindrical portion comprises a single expandable braided tube, and the capture elements comprise clot engagement members configured to project from the generally cylindrical portion in the deployed state.

12. The system of claim 11 wherein the clot engagement members comprise arcuate members that form hook-like members projecting from the generally cylindrical portion.

13. The system of claim 11 wherein the clot engagement members are formed from wires of the expandable braided tube that defines the generally cylindrical portion.

14. The system of claim 11 wherein the clot engagement members are formed from separate wires that project through interstices of the expandable braided tube that defines the generally cylindrical portion.

15. A pulmonary embolism treatment device, comprising:

an outer elongated member having a distal end;

an inner elongated member within the outer elongated member, wherein the inner elongated member and the outer elongated member slides relative to each other, and wherein the inner elongated member has a distal end; and

an expandable member having a proximal portion fixed to the distal end of the outer elongated member and a distal portion fixed to the distal end of the inner elongated member, the expandable member having a generally cylindrical portion and a plurality of capture elements arranged along the generally cylindrical portion, wherein the generally cylindrical portion and the capture elements are configured to move from a low-profile undeployed state sized to fit within a delivery catheter to a deployed state in which the generally cylindrical portion has a first cross-sectional dimension greater than that of the low-profile state and the capture elements project outwardly from the generally cylindrical portion,

wherein the generally cylindrical portion has a first longitudinal dimension and each of the capture elements has a second longitudinal dimension, the first longitudinal dimension being greater than the second longitudinal dimension.

16. The pulmonary embolism treatment device of claim 15 wherein the expandable member comprises a braided material.

17. The pulmonary embolism treatment device of claim 15 wherein the device has a plurality of generally cylindrical portions and the capture elements are separated by individual generally cylindrical portions, and wherein (a) the capture elements comprise capture portions formed from a continuous shape-memory braided material heat-set to the deployed state and (b) the capture portions project from the generally cylindrical portions to a second cross-sectional dimension in the deployed state.

18. The pulmonary embolism treatment device of claim 17 wherein the generally cylindrical portions comprise cylindrical portions and the first cross-sectional dimension comprises a first diameter in the deployed state, and the capture portions comprise disk-like projections having a second diameter greater than the first diameter in the deployed state.

19. The pulmonary embolism treatment device of claim 15 wherein the generally cylindrical portion has an expansion ratio from the undeployed state to the deployed state from 1:

4 to 1;

8.

20. The pulmonary embolism treatment device of claim 15 wherein the generally cylindrical portion has an expansion ratio from the undeployed state to the deployed state from 1:

5 to 1;

7.