Methods and apparatus for treating embolism

• US 10,238,406 B2
• Filed: 10/21/2014
• Issued: 03/26/2019
• Est. Priority Date: 10/21/2013
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: Inari Medical, Inc.
• Inventors: Cox, Brian J., Lubock, Paul, Rosenbluth, Robert, Quick, Richard, Marchand, Philippe
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/031,102
• Publication Number:
  US 20160287276A1
• Time in Patent Office: 1,617 Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A device and method for intravascular treatment of an embolism, and particularly a pulmonary embolism, is disclosed herein. One aspect of the present technology, for example, is directed toward a clot treatment device that includes a support member having a plurality of first clot engagement members and second clot engagement members positioned about the circumference of a distal portion of the support member. In an undeployed state, individual first clot engagement members can be linear and have a first length, and individual second clot engagement members can be linear and have a second length that is less than the first length. The clot engagement members can be configured to penetrate clot material along an arcuate path and hold clot material to the clot treatment device.

Claims

1. A clot treatment device for treating an embolism within a blood vessel, the clot treatment device comprising:

a support member configured to extend through a delivery catheter, wherein the support member has a proximal portion and a distal portion;

a plurality of first clot engagement members positioned about the circumference of the distal portion of the support member, wherein, in deployed state, individual first clot engagement members extend radially outwardly with respect to the support member and have a curved portion that includes a first radially furthest apex that extends a first radial distance from the support member;

a plurality of second clot engagement members positioned about the circumference of the distal portion of the support member, wherein, in the deployed state, individual second clot engagement members have a curved portion that includes a second radially furthest apex that extends a second radial distance from the support member, and wherein the first radial distance is greater than the second radial distance;

wherein, in the deployed state, individual curved portions of the first and second clot engagement members project radially outwardly relative to the support member in a curve that has a proximally extending section which defines a proximally facing concave portion, and wherein the curved portion of the first and second clot engagement members further includes an end section that curves radially inwardly from the proximally extending section;

wherein the first clot engagement members have a first stiffness and the second clot engagement members have a second stiffness greater than the first stiffness, and

wherein the clot engagement members are configured to penetrate clot material along an arcuate path and hold clot material to the clot treatment device.

2. The clot treatment device of claim 1, further comprising:

a first hub positioned around the support member at a first location; and

a second hub positioned around the support member at a second location spaced apart from the first location along the support member;

wherein—

individual first clot engagement members extend from the first hub, wherein a proximal portion of the first clot engagement members are integral with the first hub; and

individual second clot engagement members extend from the second hub, wherein a proximal portion of the second clot engagement members are integral with the second hub.

3. The clot treatment device of claim 1 wherein:

at least one of the first radially furthest apices of the individual first clot engagement members are configured to engage the vessel wall in the deployed state; and

none of the second radially furthest apices of the individual second clot engagement members are configured to engage the vessel wall in the deployed state.

4. The clot treatment device of claim 1 wherein:

the first clot engagement members are positioned about the support member at a first location along the length of the support member; and

the second clot engagement members are positioned about the support member at a second location along the length of the support member that is spaced longitudinally apart from the first location along the support member.

5. The clot treatment device of claim 1, further comprising:

a plurality of third clot engagement members positioned about the circumference of the distal portion of the support member, wherein, in the deployed state, individual third clot engagement members extend radially outwardly with respect to the support member and have a curved portion that includes a third radially furthest apex that extends a third radial distance from the support member; and

wherein the third radial distance is substantially the same as the first radial distance.

6. The clot treatment device of claim 5, further comprising:

a plurality of fourth clot engagement members positioned about the circumference of the distal portion of the support member, wherein, in the deployed state, individual fourth clot engagement members extend radially outwardly with respect to the support member and have a curved portion that includes a fourth radially furthest apex that extends a fourth radial distance from the support member; and

wherein the fourth radial distance is substantially the same as the second radial distance.

7. The clot treatment device of claim 6 wherein:

the first clot engagement members are positioned at a first location along the length of the support member;

the second clot engagement members are positioned at a second location along the length of the support member that is different than the first location;

the third clot engagement members are positioned at a third location along the length of the support member that is different than the first and second locations;

the fourth clot engagement members are positioned at a fourth location along the length of the support member that is different than the first, second, and third locations.

8. The clot treatment device of claim 1, further comprising:

a plurality of third clot engagement members positioned about the circumference of the distal portion of the support member, wherein, in the deployed state, individual third clot engagement members extend radially outwardly with respect to the support member and have a curved portion that includes a third radially furthest apex that extends a third radial distance from the support member; and

wherein the third radial distance is different than the second radial distance and the first radial distance.

9. The clot treatment device of claim 1, further comprising:

a plurality of third clot engagement members positioned about the circumference of the distal portion of the support member, wherein, in the deployed state, individual third clot engagement members extend radially outwardly with respect to the support member and have a curved portion that includes a third radially furthest apex that extends a third radial distance from the support member; and

wherein, in the deployed state, individual curved portions of the third engagement members project radially outwardly relative to the support member in a curve that has a distally extending section which defines a distally facing concave portion, and wherein the curved portion of individual third engagement members further includes an end section that curves radially inwardly from the distally extending section.

10. A clot treatment device for treating an embolism within a blood vessel, the clot treatment device moveable between a low-profile undeployed state and a deployed state, the clot treatment device comprising:

a support member configured to extend through a delivery catheter, wherein the support member has a proximal portion and a distal portion;

a plurality of first clot engagement members positioned about the circumference of the distal portion of the support member, wherein, in the undeployed state, individual first clot engagement members are linear and have a first length;

a plurality of second clot engagement members positioned about the circumference of the distal portion of the support member, wherein, in the undeployed state, individual second clot engagement members are linear and have a second length that is less than the first length;

wherein, in the deployed state, the individual first and second clot engagement members project radially outwardly relative to the support member in a curve that has a proximally extending section which defines a proximally facing concave portion,

and

wherein the clot engagement members are configured to penetrate clot material along an arcuate path and hold clot material to the clot treatment device.

11. The clot treatment device of claim 10 wherein the curve further includes an end section that curves radially inwardly from the proximally extending section.

12. The clot treatment device of claim 10 wherein, in the undeployed state:

individual first clot engagement members are positioned parallel to the support member; and

individual second clot engagement members are positioned parallel to the support member.

13. The clot treatment device of claim 10, further comprising:

a first hub positioned around the support member at a first location; and

a second hub positioned around the support member at a second location spaced apart from the first location along the support member;

wherein—

individual first clot engagement members extend distally from the first hub in the undeployed state, wherein a proximal portion of the first clot engagement members are integral with the first hub; and

individual second clot engagement members extend distally from the second hub in the undeployed state, wherein a proximal portion of the second clot engagement members are integral with the second hub.