Devices and systems for thrombus treatment

• US 10,105,158 B2
• Filed: 11/09/2015
• Issued: 10/23/2018
• Est. Priority Date: 08/14/2012
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Friedman, Nathan L., Zacharias, Eric H.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US14/935,833
• Publication Number:
  US 20160120571A1
• Time in Patent Office: 1,079 Days
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

A thrombus treatment device includes a support wire, a body frame portion that is disposed about an axis defined by the support wire, one or more tethers that each have a first end and a second end, and a filter element extending from the body frame portion. Each of the one or more tethers is attached at its first end to the body frame portion, and at its second end to a collar that couples the second end of each of the multiple tethers to the support wire. When the collar is positioned substantially within a region interior of the body frame portion, a rotational actuation of the support wire causes a swiveling motion of the one or more tethers.

Claims

1. A method of treating a thrombus, comprising:

introducing a catheter to a patient and advancing a distal end of the catheter to a treatment site;

advancing a thrombus treatment device through a lumen of the catheter, the thrombus treatment device comprising;

(a) a support tube, (b) a body frame portion that is disposed about an axis defined by the support tube, the body frame portion including a proximal end and a distal end, (c) a filter portion that extends from the distal end of the body frame portion, and (d) multiple tethers each having a first end and a second end, wherein the first end of each of the multiple tethers extends out a proximal end of the support tube, the tethers extending through a lumen of the support tube and out a distal end of the support tube and engaging the body frame portion near the distal end of the body frame portion and extending to the proximal end of the body frame portion, the second end of each of the multiple tethers being coupled to the body frame portion near the proximal end of the body frame portion;

positioning the thrombus treatment device within the lumen of the catheter such that the body frame portion is generally aligned with at least a portion of a thrombus at the treatment site; and

proximally withdrawing the catheter, wherein the body frame portion expands from a collapsed state to an expanded state with a radial force sufficient to embed in the thrombus in response to the proximal withdrawal of the catheter.

2. The method of claim 1, wherein each tether extends from the distal end of the support tube to the proximal end of the body frame portion such that an intermediate portion of each tether engages the body frame portion near the distal end of the body frame portion.

3. The method of claim 1, wherein each tether of the multiple tethers forms a loop around the body frame portion near the proximal end of the body frame portion.

4. The method of claim 1, wherein the multiple tethers collectively form a loop around the body frame portion near the proximal end of the body frame portion.

5. The method of claim 1, wherein the body frame portion is adapted to open a flow channel through the thrombus when the body frame portion expands and contacts the thrombus.

6. The method of claim 1, wherein the filter portion is adapted to capture thrombus particles displaced by the expansion of the body frame portion.

7. The method of claim 1, further comprising pretreating the filter portion with a thrombogenic material or autologous blood.

8. The method of claim 7, wherein the thrombus treatment device acts as an occluder while the thrombogenic material or autologous blood restricts blood flow through the filter portion.

9. The method of claim 8, further comprising delivering a thrombolytic agent to the thrombus.

10. The method of claim 1, further comprising, applying proximally directed force to the at least one tether such that a portion of the at least one tether moves proximally relative to the support tube, the proximally directed force causing the proximal end and the distal end of the body frame to collapse radially from the expanded state to the collapsed state, and

proximally withdrawing the thrombus treatment device from the treatment site with the thrombus treatment device in its collapsed state.

11. A method of treating a thrombus, comprising:

introducing a catheter to a patient and advancing a distal end of the catheter to a treatment site;

advancing a thrombus treatment device in a collapsed state through a lumen of the catheter, the thrombus treatment device comprising;

(a) a support tube, (b) a body frame portion disposed about an axis defined by the support tube, (c) a filter portion, and (d) at least one tether, said at least one tether having a first end and a second end, the first end extending out a proximal end of the support tube and the second end extending out of a distal end of the support tube such that the second end is coupled to the body frame portion near a proximal end of the body frame portion;

positioning the thrombus treatment device within the lumen of the catheter such that the body frame portion is generally aligned with at least a portion of a thrombus at the treatment site; and

proximally withdrawing the catheter such that the body frame portion radially expands from a collapsed state to an expanded state, said radial expansion causing a portion of the at least one tether to move relative to the support tube, said radial expansion causing a portion of the body frame to embed in the thrombus.

12. The method of claim 11, wherein the at least one tether extends from the distal end of the support tube to the proximal end of the body frame portion such that an intermediate portion of each tether engages the body frame portion near the distal end of the body frame portion.

13. The method of claim 11, wherein each tether of the multiple tethers forms a loop around the body frame portion near the proximal end of the body frame portion.

14. The method of claim 11, wherein the thrombus treatment device comprises multiple tethers, and wherein the multiple tethers collectively form a loop around the body frame portion near the proximal end of the body frame portion.

15. The method of claim 11, wherein the body frame portion is adapted to open a flow channel through the thrombus when the body frame portion expands and contacts the thrombus.

16. The method of claim 11, wherein the filter portion is adapted to capture thrombus particles displaced by the expansion of the body frame portion.

17. The method of claim 11, further comprising pretreating the filter portion with a thrombogenic material or autologous blood.

18. The method of claim 17, wherein the thrombus treatment device acts as an occluder while the thrombogenic material or autologous blood restricts blood flow through the filter portion.

19. The method of claim 18, further comprising delivering a thrombolytic agent to the thrombus.

20. The method of claim 11, further comprising, applying proximally directed force to the at least one tether such that a portion of the at least one tether moves proximally relative to the support tube, the proximally directed force causing the proximal end and the distal end of the body frame to collapse radially from the expanded state to the collapsed state, and

proximally withdrawing the thrombus treatment device from the treatment site with the thrombus treatment device in its collapsed state.