Rotational mechanical thrombectomy device

Patent metadata

Field	Value
Publication number	US-10555752-B2
Application number	US-201715426137-A
Country	US
Kind code	B2
Filing date	Feb 7, 2017
Priority date	Feb 8, 2016
Publication date	Feb 11, 2020
Grant date	Feb 11, 2020

Abstract

The present disclosure relates to a mechanical thrombectomy device that includes a catheter assembly with a basket assembly formed of a proximal hub and a distal hub; a flexible tube having a first end attached to the proximal hub and a second end attached to the distal hub; and a plurality of basket wires. The flexible tube may be laser-cut to allow for bending, elongation, and compression. The basket wires each have a first end attached to the proximal hub and a second end attached to the distal hub. The basket wires are disposed around the flexible tube and configured to expand to a preset shape. The basket assembly is attached to a distal end of a rotatable shaft. A drive assembly is configured to rotate the rotatable shaft to rotate the basket assembly. The basket assembly when rotated is configured to macerate a material proximate to the basket assembly.

First claim

What is claimed is:

1. A mechanical thrombectomy device, the device comprising:
a catheter assembly comprising:
a rotatable shaft having a proximal end and a distal end; and
a basket assembly attached to the distal end of the rotatable shaft, the basket assembly comprising:
a proximal hub and a distal hub disposed on a longitudinal axis of the basket assembly;
a flexible inner tube having a first end attached to the proximal hub and a second end attached to the distal hub; and
a plurality of basket wires, each of the plurality of basket wires having a first end attached to the proximal hub and a second end attached to the distal hub, the plurality of basket wires disposed around the flexible inner tube, the plurality of basket wires configured to expand to a preset shape; and

a drive assembly configured to rotate the rotatable shaft,
wherein the basket assembly is configured to rotate with the rotatable shaft to macerate a material proximate to the basket assembly, and
wherein the flexible inner tube comprises a plurality of independent pieces separated by perforations such that the flexible inner tube can bend relative to the longitudinal axis of the basket assembly in the absence of a guidewire when the proximal hub and the distal hub are aligned along the longitudinal axis.

2. The mechanical thrombectomy device of claim 1 , further comprising:
a sheath configured to cover the plurality of basket wires and prevent expansion of the plurality of basket wires; and
a retracting mechanism attached to a proximal end of the sheath, the retracting mechanism configured to retract the sheath to allow expansion of the plurality of basket wires.

3. The mechanical thrombectomy device of claim 2 , further comprising:
an infusion port for receiving a fluid,
wherein an outside surface of the rotatable shaft and an inside surface of the sheath define an infusion lumen, and the infusion lumen is configured to deliver the fluid received by the infusion port to a proximity of the material.

4. The mechanical thrombectomy device of claim 1 , wherein the drive assembly comprises:
a motor;
a first actuation mechanism configured to actuate the motor to rotate the rotatable shaft;
a battery configured to supply power to the motor; and
a circuit board.

5. The mechanical thrombectomy device of claim 4 , wherein the circuit board is configured to disconnect power to the motor from the battery when a current load of the motor is greater than a predefined threshold value.

6. The mechanical thrombectomy device of claim 5 , wherein the drive assembly further comprises a reset switch, and the reset switch is configured to reconnect power to the motor from the battery.

7. The mechanical thrombectomy device of claim 4 , wherein the motor, the first actuation mechanism, the battery, and the circuit board are disposed in a handle housing, and the handle housing comprises a grip area having ergonomic features.

8. The mechanical thrombectomy device of claim 7 , wherein the handle housing further comprises a trigger guard configured to surround a portion of the first actuation mechanism.

9. The mechanical thrombectomy device of claim 4 , wherein the drive assembly further comprises a gear train, the gear train comprising:
a first gear attached to a motor shaft of the motor; and
a second gear configured to engage the first gear,
wherein the motor, the first gear, and the second gear are mounted to a frame, and the motor is configured to rotate the first gear and the second gear.

10. The mechanical thrombectomy device of claim 9 , wherein the catheter assembly comprises a third gear, the second gear of the gear train is further configured to engage with the third gear and to rotate the third gear, and the third gear is configured to rotate the rotatable shaft.

11. The mechanical thrombectomy device of claim 10 , wherein a proximal end of the catheter assembly is enclosed in a cartridge assembly, the cartridge assembly is detachable from the drive assembly, the cartridge assembly further comprises a locking mechanism, the locking mechanism is configured to lock a position of the third gear when the cartridge assembly is detached from the drive assembly, and the cartridge assembly is configured to transfer a manual rotation of the cartridge assembly to the rotatable shaft when the position of the third gear is locked.

12. The mechanical thrombectomy device of claim 11 , wherein the locking mechanism comprises a spring.

13. The mechanical thrombectomy device of claim 1 , wherein the plurality of basket wires comprises at least four basket wires.

14. The mechanical thrombectomy device of claim 1 , wherein the distal hub of the basket assembly comprises a conical tip.

15. The mechanical thrombectomy device of claim 14 , wherein the conical tip comprises at least one of: a cross-cut engraving, a concentric engraving, and a spiral engraving.

16. The mechanical thrombectomy device of claim 1 , further comprising a center lumen configured to receive a guidewire, wherein the center lumen extends through an inner lumen of the rotatable shaft and an inner lumen of the flexible inner tube.

17. The mechanical thrombectomy device of claim 1 , wherein the perforations of the flexible inner tube form a jigsaw pattern.

18. The mechanical thrombectomy device of claim 1 , wherein the flexible inner tube is configured to elongate, to compress, and to rotate.

19. A catheter assembly of a medical thrombectomy device, the catheter assembly comprising:
a rotatable shaft having a proximal end and a distal end; and
a basket assembly attached to the distal end of the rotatable shaft, the basket assembly comprising:
a proximal hub and a distal hub disposed on a longitudinal axis of the basket assembly;
a flexible inner tube having a first end attached to the proximal hub and a second end attached to the distal hub; and
a plurality of basket wires, each of the plurality of basket wires having a first end attached to the proximal hub and a second end attached to the distal hub, the plurality of basket wires disposed around the flexible inner tube, the plurality of basket wires configured to expand to a preset shape,

wherein the basket assembly is configured to rotate to macerate a material proximate to the basket assembly, and
wherein the flexible inner tube comprises a plurality of independent pieces separated by perforations such that the flexible inner tube can bend relative to the longitudinal axis of the basket assembly in the absence of a guidewire when the proximal hub and the distal hub are aligned along the longitudinal axis.

20. A method of treating thrombosis, comprising:
inserting a distal end of a catheter assembly into a vasculature, the catheter assembly comprising:
a rotatable shaft;
a basket assembly, the basket assembly disposed at the distal end of the catheter assembly, the basket assembly attached to the rotatable shaft, the basket assembly comprising:
a proximal hub and a distal hub disposed on a longitudinal axis of the basket assembly;
a flexible inner tube having a first end attached to the proximal hub and a second end attached to the distal hub, the flexible inner tube comprising perforations such that the flexible inner tube and the basket assembly can bend relative to the longitudinal axis of the basket assembly in the absence of a guidewire when the proximal hub and the distal hub are aligned along the longitudinal axis; and
a plurality of basket wires, each of the plurality of basket wires having a first end attach

Assignees

• Teleflex Medical Inc

Inventors

• Robertson Taylor
• Roth Brian K
• Trexler Wade K
• Bohn Richard E
• Rowe David
• Denlinger Rodney Wilmer
• Skelton Eugene
• Wright Anthony
• Benson Ronan

Classifications

• A61B2017/00424

  ergonomic, e.g. fitting in fist · CPC title

• A61B2017/00973

  pedal-operated · CPC title

• A61B17/320725

  with radially expandable cutting or abrading elements (A61B17/32075 takes precedence) · CPC title

• A61B2017/320775

  Morcellators, impeller or propeller like means · CPC title

• A61B17/320758 Primary

  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 title