Devices and systems for thrombus treatment

• US 9,579,119 B2
• Filed: 03/07/2016
• Issued: 02/28/2017
• 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): Manahan, Todd E
• Assistant Examiner(s): HERBERMANN, ERICH G.
• Application Number:
  US15/062,738
• Publication Number:
  US 20160183965A1
• Time in Patent Office: 358 Days
• Field of Search: 606/200, 606/159, 606/114, 606/128, 606/127, 606/110
• US Class Current: 1/1
• 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. 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 advanced to a position 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. The swiveling motion of the tethers operates to macerate a thrombus.

Claims

1. A method of treating a thrombus, comprising:

inserting a catheter having a proximal end and a distal end into a patient and advancing the distal end of the catheter to a treatment site;

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

(a) a body frame portion, wherein the body frame portion defines one or more interstices, (b) a tether portion that includes one or more tethers, said one or more tethers extending from the body frame portion to a collar that is coupled to a support wire, and (c) a filter portion that extends from the body frame portion;

positioning the thrombus treatment device within the lumen of the catheter at a position wherein the body frame portion is generally aligned with at least a portion of a thrombus at the treatment site, and proximally withdrawing the catheter;

providing a distally directed force to the support wire to advance the collar to a location substantially within a region interior of the body frame portion or substantially within a region interior of the filter portion; and

rotationally actuating the support wire, wherein the rotational actuation of the support wire causes a swiveling motion of the one or more tethers, the one or more tethers being adapted to macerate the thrombus.

2. The method of claim 1, wherein the swiveling motion of the one or more tethers operates to cause thrombotic material protruding through one or more interstices defined by the body frame portion to be severed.

3. The method of claim 1, wherein a rotation of the support wire causes the one or more tethers to sweep through a range of motion without imparting substantial motion to the body frame portion.

4. The method of claim 1, wherein the rotation of the support wire causes substantially zero motion at the body frame portion.

5. The method of claim 4, wherein the rotation of the support wire through about 360 degrees causes substantially zero motion at the body frame portion.

6. The method of claim 4, wherein a rotation of the support wire through about 180 degrees causes the portion of the one or more tethers to sweep through a range of motion without imparting substantial motion to the body frame portion.

7. The method of claim 1, wherein the device includes, with respect to the rotational actuation, a neutral position associated with a zero-degree rotation of the support wire, a first torqued position associated with a clockwise rotation of the support wire, and a second torqued position associated with a counter-clockwise rotation of the support wire.

8. The method of claim 7, wherein the one or more tethers comprise an “

S”

shape when the device is in the neutral position.

9. The method of claim 7, wherein the one or more tethers comprise a first generally linear shape when the device is in the first torqued position, and comprise a second generally linear shape when the device is in the second torqued position.

10. The method of claim 7, wherein the one or more tethers comprise a looped configuration when the device is in the neutral position.

11. A method of treating a thrombus, comprising:

inserting a catheter having a proximal end and a distal end into a patient and advancing the distal end of the catheter to a treatment site;

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

(a) a body frame portion, (b) a tether portion that includes one or more tethers, said one or more tethers extending from the body frame portion to a collar that is coupled to a support wire, and (c) a filter portion that extends from the body frame portion;

positioning the thrombus treatment device within the lumen of the catheter at a position wherein the body frame portion is generally aligned with at least a portion of a thrombus at the treatment site, and proximally withdrawing the catheter;

providing a distally directed force to the support wire to advance the collar to a location substantially within a region interior of the body frame portion or substantially within a region interior of the filter portion; and

actuating the support wire to cause one or more of the tethers to macerate the thrombus, wherein the actuation of the support wire causes a portion of the one or more tethers to sweep through a range of motion relative to the body frame and the thrombus.

12. The method of claim 11, wherein said one or more tethers extend from a distal end of the body frame portion and the filter portion extends from a proximal end of the body frame portion.

13. The method of claim 11, wherein the body frame portion defines one or more closed interstices.

14. The method of claim 13, wherein actuation of the support wire causes the one or more tethers to operate to cause thrombotic material protruding through the one or more interstices defined by the body frame portion to be severed.

15. The method of claim 14, wherein the filter operates to capture any severed thrombotic material while permitting blood cells to pass therethrough.

16. The method of claim 11, wherein actuation of the support wire causes actuation of the one or more tethers without imparting substantial motion to the body frame portion.

17. The method of claim 11, wherein the actuation of the support wire includes translating the support wire distally and proximally in an oscillating manner.

18. The method of claim 17, where the actuation of the support wire further includes rotating the support wire to cause a swiveling motion of at least a portion of the one or more tethers.

19. The method of claim 18, wherein actuation of the support wire causes actuation of the one or more tethers without imparting substantial motion to the body frame portion.

20. The method of claim 18, wherein during actuation, the support wire is simultaneously translated and rotated.