METHODS AND APPARATUS FOR TREATING EMBOLISM

• US 20140324091A1
• Filed: 05/28/2014
• Published: 10/30/2014
• Est. Priority Date: 11/20/2012
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: Inceptus Medical, Llc
• Inventors: Rosenbluth, Robert F., Cox, Brian J., Lubock, Paul
• Granted Patent: US 8,968,330 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• 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 device for treating a pulmonary embolism that at least partially restricts blood flow through a pulmonary vessel, the device comprising:

an elongated shaft having a proximal region and a distal region;

an expandable braid attached to the distal region of the elongated shaft, the braid having a plurality of radially extending portions and at least one cylindrical portion, and the radially extending portions and the cylindrical portion being configured to move from a compressed state sized to fit in a delivery catheter to an expanded state;

wherein the cylindrical portion is between a pair of the radially extending portions, and in the expanded state the cylindrical portion is configured to press radially outward against the pulmonary embolism;

wherein the radially extending portions extend radially outward from the cylindrical portion in the expanded state such that portions of the pulmonary embolism are retained between the radially extending portions; and

wherein the cylindrical portion has a first length along a longitudinal direction of the braid in the expanded state and the radially extending portions have a second length along the longitudinal direction of the braid in the expanded state that is less that the first length.

2. The device of claim 1 wherein at least a portion of the individual radially extending portions is disk-shaped.

3. The device of claim 1 wherein the individual radially extending portions include a curved portion and a linear portion.

4. The device of claim 1 wherein, in the expanded state, an exterior surface area of the device is at least two times to four times greater than the surface area of a uniformly cylindrical device.

5. The device of claim 1 wherein the braid includes a plurality of filaments, and wherein:

in the delivery state, the filaments form a first angle with respect to an axis of the device; and

in the expanded state, the filaments form a second angle with respect to an axis of the device that is different than the first angle.

6. A device for treating a pulmonary embolism that at least partially blocks a pulmonary vessel, the device comprising:

an elongated shaft having a proximal region and a distal region;

an expandable braid attached to the distal region of the elongated shaft, the braid having a plurality of radially extending portions and a cylindrical portion between the radially extending portions, and the radially extending portions and the cylindrical portion being configured to move from a compressed state sized to fit in a delivery catheter to an expanded state;

wherein the cylindrical portion is configured to press radially outward against the pulmonary embolism such that the cylindrical portion forms an expanded flow channel through the pulmonary embolism; and

wherein the radially extending portions are configured to project radially outward from the cylindrical portion in the expanded state such that a portion of the pulmonary embolism is retained between the radially extending portions, and at least a portion of the radially extending portions are disk-shaped.

7. The device of claim 6 wherein the radially extending portions are defined by a cylindrical disk shape with a linear triangular cross-section.

8. The device of claim 6 wherein the expandable braid is self-expanding and made of a superelastic material.

9. The device of claim 6 wherein, in the expanded state, an exterior surface area of the device is at least two times to four times greater than the surface area of a uniformly cylindrical device.

10. The device of claim 6 wherein the braid includes a plurality of filaments, and wherein:

in the delivery state, the filaments form a first angle with respect to an axis of the device; and

in the expanded state, the filaments form a second angle with respect to an axis of the device that is different than the first angle.

11. A device for treating a pulmonary embolism that at least partially blocks a pulmonary vessel, the device comprising:

an elongated shaft having a proximal region and a distal region;

an expandable braid attached to the distal region of the elongated shaft, the braid having a plurality of radially extending portions and a plurality of cylindrical portions such that individual cylindrical portions are between a pair of the radially extending portions, and the radially extending portions and the cylindrical portions are configured to move from a compressed state sized to fit within a delivery catheter to an expanded state;

wherein at least a portion of the individual radially extending portions has a disk-like shape;

wherein the cylindrical portions are configured to expand radially outward in the expanded state; and

wherein the radially extending portions are configured to project radially outward from the cylindrical portions in the expanded state such that a portion of the pulmonary embolism is retained between the radially extending portions.

12. The device of claim 11 wherein the radially extending portions individually have a curved edge configured to engage at least a portion of the pulmonary embolism.

13. The device of claim 11 wherein the cylindrical portions have a first length along a longitudinal direction of the braid in the expanded state and the radially extending portions have a second length along the longitudinal direction of the braid in the expanded state that is less that the first length.

14. The device of claim 11 wherein, in the expanded state, an exterior surface area of the device is at least two times to four times greater than the surface area of a uniformly cylindrical device.

15. The device of claim 11 wherein the braid includes a plurality of filaments, and wherein:

in the delivery state, the filaments form a first angle with respect to an axis of the device; and

in the expanded state, the filaments form a second angle with respect to an axis of the device that is different than the first angle.

16. An expandable device for the treatment of a vascular embolus, comprising:

a self-expanding elongate mesh configured to move from a compressed state sized to be in a delivery catheter to an expanded state for use in a blood vessel, the mesh having a proximal end, a cylindrical portion configured to define a flow channel in the expanded state through which blood can flow through the embolus, at least one radially extending portion, and a distal end, wherein the radially extending portion extends radially outward from the cylindrical portion in the expanded state and has a curved edge configured to engage at least a portion of the embolus; and

a plurality of hub members including a proximal hub at the proximal end and a distal hub at the distal end, wherein each of the proximal and distal hubs has a lumen configured to allow passage of an instrument therethrough.

17. The device of claim 16 wherein at least a portion of the individual radially extending portions is disk-shaped.

18. The device of claim 16 wherein the mesh is self-expanding and made of a shape memory material.

19. The device of claim 16 wherein, in the expanded state, an exterior surface area of the device is at least two times to four times greater than the surface area of a uniformly cylindrical device.

20. The device of claim 16 wherein the mesh includes a plurality of filaments, and wherein:

in the delivery state, the filaments form a first angle with respect to an axis of the device; and

in the expanded state, the filaments form a second angle with respect to an axis of the device that is different than the first angle.