Methods and Devices for Removal of Thromboembolic Material

• US 20160166266A1
• Filed: 04/09/2015
• Published: 06/16/2016
• Est. Priority Date: 12/16/2014
• Status: Active Grant

• Current Assignee: Penumbra, Inc.
• Original Assignee: Penumbra, Inc.
• Inventors: Nita, Henry
• Granted Patent: US 9,943,321 B2
• Time in Patent Office: 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 17/320758 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22078 for rotating the instrument within a channel, e.g. an optical fibre
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Methods and devices to remove thromboembolic material from the human body using rotational energy and aspiration are disclosed. A thromboembolic removal system includes an extraction device and drive unit. The extraction device is introduced to the treatment area and activated by the drive unit to separate, break apart, loosen or soften thromboembolic material and to facilitate its aspiration outside the patient.

Claims

1. An extraction device for removing thromboembolic material from a patient, comprising:

a drive unit that rotates within 100 to 500,000 RPM;

an elongated rotational member made at least partially of cable having a proximal end that is connected to the drive unit, and a distal tip having a shaped configuration; and

an aspiration catheter at least partially surrounding the rotational member and having an aspiration passage;

wherein the rotational member traverses concomitant bends as the aspiration catheter during a therapeutic procedure.

2. The device of claim 1, wherein the shaped configuration positioned at the distal tip of the rotational member has a radial diameter that is larger than the dimension of an adjacent proximal portion of the rotational member.

3. The device of claim 1, further including a fitting assembly.

4. The device of claim 1, wherein the drive unit includes at least one of the following:

an aspiration pump, an electrical motor, or both.

5. The device of claim 1, wherein the rotational member circles distally using one of the following motions:

angular motion, reciprocal motion, off-centered motion, or combinations thereof.

6. The device of claim 1, wherein the rotational member comprises at least one longitudinal element selected from the group consisting of:

a single solid rod, multiple solid rods, a bundle, strands, cable, a tube, and combinations thereof.

7. The device of claim 1, wherein the structure of the rotational member comprises polymer, metal, metal alloys or combinations thereof.

8. The device of claim 1, wherein shaped configuration of the distal tip of the rotational member is selected from the group consisting of:

winged, quarter sinusoidal, half-sinusoidal, finned, blade, hook, loop, basket, bend, coil and braid.

9. The device of claim 1, wherein the aspiration catheter is one of the following:

an integral part of the extraction device, or detachable from the extraction device.

10. The device of claim 1 wherein the aspiration catheter is fluidly coupled with an aspiration pump.

11. The device of claim 1, wherein the aspiration catheter has a separate guidewire lumen.

12. The device of claim 1, wherein the aspiration catheter and the rotational member are further configured to deliver radiofrequency for the blood vessel or for tissue cauterization.

13. The device of claim 1, wherein the gap formed between the radial diameter of the rotational member and inner diameter of the aspiration catheter is between 0 and 5 mm.

14. The device of claim 1, further comprising a radiopaque marker positioned at one of the following locations:

on the distal end of the aspiration catheter, on the distal end of the rotational member, or at both locations.

15. The device of claim 1, wherein the distal tip of the rotational member is housed in a one of the following locations:

inside the aspiration catheter, outside of the aspiration catheter, even with the aspiration catheter, or moveable between the inside and outside of the distal end of the aspiration catheter.

16. The device of claim 3, wherein the fitting assembly includes a Y-connector, a rigid tube and a stopper positioned on the rigid tube to prevent the distal tip of the rotational member from being exposed outside the aspiration catheter.

17. The device of claim 1, further comprising an aperture along the extraction device in fluid communication with the aspiration catheter and configured to regulate the level of the vacuum used for aspiration.

18. The device of claim 1, wherein the rotational member has a profile selected from the group consisting of:

continuous diameter along its length, tapered along its entire length, tapered along the distal portion in a distal direction, at least partially tapered in the proximal direction, multi-tapered, and combinations thereof.

19. The device of claim 1, wherein the rotational member comprises a rod, and wherein the cable has a distal end that is attached a proximal end of the rod.

20. The device of claim 1, wherein the rotational member transmits torque in one of the following directions:

one direction clockwise, one direction counterclockwise, or both directions.

22. The device of claim 20, wherein rotational member rotates in one of the following modes:

continuous, modulated, ON/OFF.

23. The device of claim 20, wherein the distal tip of the rotational member applies centripetal forces to the thromboembolic material.

24. The device of claim 20, further including a separate guidewire lumen.

21. An extraction device for removing thromboembolic material from a patient, comprising:

a drive unit that rotates within 100 to 500,000 RPM;

an elongated rotational member made at least partially of two rods or wires and having a distal tip, and a proximal end that is connected to the drive unit;

an aspiration catheter at least partially surrounding the rotational member and having aspiration passage; and

a shaped configuration positioned on the distal tip of the rotational member and having radial diameter larger than the adjacent proximal portion of the rotational member.