Shape memory embolectomy devices and systems

Patent metadata

Field	Value
Publication number	US-11406401-B2
Application number	US-201916701417-A
Country	US
Kind code	B2
Filing date	Dec 3, 2019
Priority date	Apr 8, 2015
Publication date	Aug 9, 2022
Grant date	Aug 9, 2022

Abstract

An embolectomy device comprised of an expansion unit and a support unit is disclosed. The expansion unit can be actuated in response to one or more external stimuli, and the support unit, located proximately to the expansion unit, provides a force to hold the expansion unit in place and to further induce the expansion unit's radial expansion. The radial expansion of the expansion unit causes the expansion unit to physically contact a blood clot, enabling the blood clot to be removed. In some embodiments, the expansion unit can be fabricated from a shape memory polymer foam. In some embodiments the support unit can be fabricated from any elastic material including, without limitation, shape memory alloys.

First claim

What is claimed is:

1. A system comprising:
a sheath and a substrate;
a shape memory polymer (SMP) foam, wherein at least a portion of the SMP foam is slidably coupled to the substrate; and
a multi-splined support coupled to the substrate distal to the SMP foam, wherein the multi-splined support includes at least one of a shape memory (SM) material, an elastic material, or combinations thereof;
wherein the substrate, the SMP foam, and the multi-splined support are coupled to each other and configured such that: (a) in a first orientation the substrate, the SMP foam, and the multi-splined support are included in the sheath; (b) in a second orientation the substrate, the SMP foam, and the multi-splined support are deployed from the sheath and, in response to being deployed from the sheath, the multi-splined support contracts axially and expands radially, (c) in a third orientation the SMP foam expands radially in response to being deployed from the sheath and further in response to plasticization, and (d) in a fourth orientation the at least a portion of the radially expanded SMP foam slides distally along the substrate and towards the multi-splined support;
wherein the SMP foam and the multi-splined support respectively expand radially non-simultaneously with each other.

2. The system of claim 1 , wherein the multi-splined support includes the SM material.

3. The system of claim 2 , wherein the SM material includes a polymer.

4. The system of claim 1 , wherein the multi-splined support includes the elastic material.

5. The system of claim 1 , wherein in the third orientation the SMP foam expands radially in response to being deployed from the sheath and further in response to solvent-based plasticization.

6. The system of claim 1 , wherein in the third orientation the SMP foam expands radially in response to being deployed from the sheath and further in response to thermal-based plasticization.

7. The system of claim 1 , wherein the substrate includes a pusher rod.

8. The system of claim 1 , wherein the substrate includes an additional SM material.

9. The system of claim 1 , wherein:
the multi-splined support comprises a conduit and at least two splines;
the conduit is coupled to proximal portions of the at least two struts; and
the conduit is slidably coupled to the substrate.

10. The system of claim 9 , wherein the conduit and the at least two splines are all monolithic with each other.

11. The system of claim 9 wherein the conduit is configured to slide distally along the substrate when the multi-splined support contracts axially.

12. The system of claim 9 wherein the at least two splines are substantially linear in the first orientation and substantially arcuate in the second orientation.

13. The system of claim 1 , wherein:
the multi-splined support comprises at least two splines;
the substrate, the SMP foam, and the at least two splines are coupled to each other and configured such that in the fourth orientation the at least two splines directly contact a distal face of the SMP foam when the substrate is moved proximally and a proximal face of the SMP foam abuts an obstacle that resists proximal movement of the SMP foam.

14. The system of claim 1 , wherein the expanded SMP foam in the third orientation has an expanded outer diameter that, when unconstrained, is at least 150% of a maximum outer diameter of the sheath.

15. The system of claim 1 , wherein in the fourth orientation the multi-splined support directly contacts the SMP foam.

16. The system of claim 1 wherein in the third orientation the SMP foam contracts axially in response to being deployed from the sheath and further in response to plasticization.

17. The system of claim 1 wherein the substrate passes through the SMP foam and is included in at least a portion of the multi-splined support.

18. A method comprising:
advancing at least a portion of an embolectomy device through a blood vessel and past an embolus within the blood vessel;
actuating a shape memory polymer (SMP) foam of the embolectomy device;
retracting the SMP foam; and
dragging the embolus proximally in response to retracting the SMP foam;
wherein the embolectomy device comprises:
a sheath and a substrate;
the SMP foam, wherein at least a portion of the SMP foam is slidably coupled to the substrate; and
a multi-splined support coupled to the substrate distal to the SMP foam, wherein the multi-splined support includes at least one of a shape memory (SM) material, an elastic material, or combinations thereof;

wherein the substrate, the SMP foam, and the multi-splined support are coupled to each other and configured such that: (a) in a first orientation the substrate, the SMP foam, and the multi-splined support are included in the sheath; (b) in a second orientation the substrate, the SMP foam, and the multi-splined support are deployed from the sheath and, in response to being deployed from the sheath, the multi-splined support contracts axially and expands radially, (c) in a third orientation the SMP foam expands radially in response to being deployed from the sheath and further in response to plasticization, and (d) in a fourth orientation the at least a portion of the radially expanded SMP foam slides distally along the substrate and towards the multi-splined support.

19. The method of claim 18 comprising:
introducing the sheath into the blood vessel;
contacting the embolus with a proximal side of the SMP foam;
dragging the embolus proximally towards the sheath in response to contacting the embolus with the proximal side of the SMP foam; and
removing the sheath and the embolus from the blood vessel.

Assignees

• L Livermore Nat Security Llc
• Texas A & M Univ Sys

Inventors

• Szafron Jason
• Maitland Duncan
• Small Iv Ward
• Buckley Patrick R
• Muschenborn Andrea D

Classifications

• A61B17/22 Primary

  Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for · CPC title

• A61B2017/00526

  Methods of manufacturing · CPC title

• A61B2017/00871

  polymeric · CPC title

• A61B2017/2212

  having a closed distal end, e.g. a loop · CPC title

• A61B2017/00867

  shape memory effect · CPC title