Methods and apparatus for treating embolism

• US 10,709,471 B2
• Filed: 04/10/2018
• Issued: 07/14/2020
• 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, Quick, Richard
• Primary Examiner(s): Miles, Wade
• Application Number:
  US15/949,350
• Publication Number:
  US 20180296240A1
• Time in Patent Office: 826 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 for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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:

a clot treatment device including—

an expandable flow restoration portion; and

a plurality of capture elements including at least a first capture element and a second capture element, wherein the flow restoration portion is positioned between the first and second capture elements, and wherein the flow restoration 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 flow restoration portion has a cross-sectional dimension greater than that of the undeployed state and the capture elements project outwardly from the flow restoration portion;

a guide catheter having a shaft with a distal end portion, wherein the shaft includes a lumen configured to receive the clot treatment device in the undeployed state; and

an expandable guide member at the distal end portion of the shaft, wherein the expandable guide member includes a mesh having a permeable portion and a substantially non-permeable portion, wherein the non-permeable portion includes a non-permeable coating formed on a proximal portion of the mesh, and wherein the expandable guide member is configured to guide clot material into the guide catheter as the clot treatment device is withdrawn into the guide catheter.

2. The system of claim 1 wherein the permeable portion of the mesh is configured to allow blood to flow through the expandable guide member.

3. The system of claim 1 wherein the mesh is self-expanding.

4. The system of claim 1 wherein the mesh is formed from a tubular braid of elastic or super-elastic filaments that have been heat set to have a desired expanded shape.

5. The system of claim 1 wherein, when the guide catheter is positioned within a pulmonary vessel, the expandable guide member is configured to expand radially outward to contact or nearly contact the pulmonary vessel and block less than about 50% of blood flow about the guide catheter.

6. The system of claim 1 wherein the expandable guide member is configured to position the shaft at or near a center of a pulmonary vessel in which the guide catheter is positioned.

7. The system of claim 1 wherein the expandable guide member has a tapered or funnel shape for guiding thrombus material into a distal opening in the shaft.

8. The system of claim 1 wherein the substantially non-permeable portion of the mesh is affixed to the distal end portion of the shaft and the permeable portion of the mesh extends distally from the substantially non-permeable portion.

9. The system of claim 8 wherein the permeable portion has a tapered or funnel shape, and wherein the substantially non-permeable portion comprises an elastic material.

10. The system of claim 1 wherein the flow restoration 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.

11. A system for treating a pulmonary embolism, comprising:

a clot treatment device including—

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 slide 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 flow restoration portion and a plurality of capture elements arranged along the flow restoration portion, wherein the flow restoration 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 flow restoration portion has a cross-sectional dimension greater than that of the undeployed state and the capture elements project outwardly from the flow restoration portion;

a guide catheter having a shaft with a distal end portion, wherein the shaft includes a lumen configured to receive the clot treatment device in the undeployed state; and

a radially expandable guide member including a mesh having a first portion affixed to the distal end portion of the shaft and a second portion extending distally from the first portion, wherein the first portion is substantially non-permeable and the second portion is permeable, wherein the first portion includes a non-permeable coating formed thereon, and wherein the guide member is configured to guide clot material into the guide catheter as the clot treatment device is withdrawn into the guide catheter.

12. The system of claim 11 wherein, when the guide member is expanded—

the guide member defines a distal opening,

the first portion has a first diameter, and

the second portion has a second diameter greater than the first diameter.

13. The system of claim 11 wherein, when the guide catheter is positioned within a pulmonary vessel and the guide member is expanded—

the first portion is configured to divert blood flow away from the distal end portion of the shaft, and

the second portion is configured to allow blood to flow through the guide member and around the guide catheter.

14. The system of claim 11 wherein the flow restoration 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.

15. A system for treating a pulmonary embolism, comprising:

a clot treatment device configured to move from a low-profile undeployed state sized to fit within a delivery catheter to a deployed state, wherein the clot treatment device has a greater cross-sectional dimension in the deployed state than in the undeployed state;

a guide catheter having a shaft with a distal end, wherein the shaft includes a lumen configured to receive the clot treatment device in the undeployed state; and

an expandable guide member including a mesh having a first portion affixed at or near the distal end of the shaft and a second portion extending distally from the first portion, wherein the first portion includes a non-permeable coating formed thereon, and wherein the second portion is permeable to allow blood to flow through the expandable guide member when the expandable guide member is expanded.

16. The system of claim 15 wherein the second portion is radially expanding and has a tapered or funnel shape, and wherein the first portion comprises an elastic material configured to flex with expansion of the second portion.