Rotational thrombectomy device

• US 7,037,316 B2
• Filed: 04/01/2002
• Issued: 05/02/2006
• Est. Priority Date: 07/24/1997
• Status: Expired due to Term

• Current Assignee: Argon Medical Devices
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. Jr., Peters, Walter H., Hinchliffe, Peter W. H.
• Primary Examiner(s): Truong, Kevin T.
• Application Number:
  US10/113,248
• Publication Number:
  US 20020173812A1
• Time in Patent Office: 1,492 Days
• Field of Search: 606/159, 606/170, 606/174, 606/180, 606/113, 606/114, 606/127
• US Class Current: 606/159
• 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 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 2017/00734 battery operated
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320008 Scrapers
• 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: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: B82Y 10/00 Nanotechnology for information processing, storage or transmission, e.g. quantum computing or single electron logic
• CPC Class Codes: H01J 1/3042 microengineered, e.g. Spindt-type
• CPC Class Codes: H01J 2201/319 Circuit elements associated with the emitters by direct integration

Abstract

A thrombectomy apparatus for breaking up thrombus or other obstructive material in a lumen of a vascular graft or vessel comprising a flexible sheath, and a wire positioned within the flexible sheath wherein the wire and flexible sheath are relatively movable. The wire is substantially sinuous in configuration and assumes a substantially sinuous shape when in the deployed position and assumes a straighter position in the retracted position. The wire is operatively connected to a motor for rotation of the wire to enable peaks of the sinuous wire to contact a wall of the lumen to break up the thrombus or other obstructive material.

Claims

1. A thrombectomy apparatus for breaking up thrombus or other obstructive material in a lumen of a vascular graft or vessel, the apparatus comprising:

a flexible sheath extending in an axial direction;

a wire positioned within the flexible sheath; and

a motor operatively connected to the wire;

the wire and the flexible sheath being relatively movable in the axial direction so that the wire has a first configuration when positioned within the flexible sheath and a second configuration when deployed from the flexible sheath, the wire having a sinuous shape in the second configuration and a straighter shape in the first configuration, the wire being rotatable by the motor to enable peaks of the wire in the sinuous shape to contact a wall of the lumen to break up the thrombus or other obstructive material.

2. The thrombectomy apparatus of claim 1, wherein the wire includes an inner core and an outer coil.

3. The thrombectomy apparatus of claim 2, wherein the inner core is formed by at least two wires twisted together.

4. The thrombectomy apparatus of claim 2, wherein the inner core is welded within the outer coil at proximal and distal ends.

5. The thrombectomy apparatus of claim 1, wherein the wire includes a plurality of wires twisted together.

6. The thrombectomy apparatus of claim 1, further comprising a soft blunt tip affixed to a distal end of the wire.

7. The thrombectomy apparatus of claim 6, wherein a distal portion of the flexible sheath is at transverse angle to the axial direction of the sheath.

8. The thrombectomy apparatus of claim 1, further comprising a housing, the housing including the motor and a battery for supplying power to the motor, the wire extending from the housing.

9. The thrombectomy apparatus of claim 8, further comprising a metal tube operatively connected to the motor, the wire being connected to the metal tube such that rotation of the metal tube rotates the wire.

10. The thrombectomy apparatus of claim 1, further comprising first and second balloons, wherein the flexible sheath has first and second lumens, the first lumen communicating with the first balloon and the second lumen communicating with the second balloon.

11. The thrombectomy apparatus of claim 10, wherein the first balloon is an angioplasty balloon and the second balloon is configured for engaging and pulling an arterial plug, the first balloon being proximal of the second balloon.

12. The thrombectomy apparatus of claim 1, further comprising an angioplasty balloon expandable radially with respect to the flexible sheath.

13. The thrombectomy apparatus of claim 1, further comprising an inflatable balloon for engaging and pulling an arterial plug into the lumen of the graft, the balloon being expandable radially with respect to the flexible sheath.

14. A thrombectomy apparatus for breaking up thrombotic material in a vascular structure, the apparatus comprising:

a flexible sheath extending in an axial direction;

a rotatable wire positioned within the flexible sheath; and

a motor operatively connected to the wire;

the wire and the flexible sheath being relatively slidable in the axial direction so that the wire is movable between a substantially straightened configuration when positioned within the flexible sheath and a curved configuration when deployed from the flexible sheath, in the curved configuration the wire having a first arcuate region extending in a first direction and a second arcuate region spaced in the axial direction from the first arcuate region and extending in a second direction, the wire being rotatable by the motor to enable the first and second arcuate regions to break up the thrombotic material in the vascular structure.

15. The thrombectomy apparatus of claim 14, wherein the wire is formed of an inner core of twisted wires and an outer coil.

16. The thrombectomy apparatus of claim 15, further comprising an expandable balloon, wherein the flexible sheath contains a first lumen to receive the wire and a second lumen communicating with the balloon for injection of fluid to inflate the balloon.

17. A thrombectomy apparatus for breaking up thrombotic material in a vascular structure, the apparatus comprising:

a flexible sheath extending in an axial direction;

a thrombectomy wire rotatably positioned within the flexible sheath, the thrombectomy wire including at least one wire forming an inner core and at least one wire wound around the inner core to form an outer layer, the thrombectomy wire having a first arcuate region extending in a first direction, a second arcuate region extending in a second direction, and a substantially linear region; and

a motor operatively connected to the thrombectomy wire, the thrombectomy wire being rotatable by the motor to enable the first and second arcuate regions to break up the thrombotic material in the vascular structure.

18. A thrombectomy apparatus for breaking up thrombotic material in a vascular structure, the apparatus comprising:

a flexible tube;

a wire having a non-linear configuration positioned within the flexible tube and being rotatable with respect to the flexible tube;

first and second balloons connected to the flexible tube and being inflatable to expand radially with respect to the flexible tube; and

a motor operatively connected to the wire for rotating the wire to break up the thrombotic material in the vascular structure.

19. A thrombectomy apparatus for performing a thrombectomy procedure to break up thrombus from a graft functioning as a shunt between an artery and a vein, the apparatus comprising:

a flexible catheter having a declotting mechanism to break up thrombotic material or other obstructive material;

a first angioplasty balloon connected to the flexible catheter and being inflatable to expand radially with respect to the flexible catheter into a first configuration to perform an angioplasty procedure; and

a second balloon connected to the flexible catheter and being inflatable to a second configuration capable of pulling vascular material into the graft, the second configuration being different from the first configuration.

20. A method for breaking up thrombotic material from a lumen of a vascular graft or vessel, the method comprising:

inserting a sheath into the lumen;

deploying a wire with from the sheath, the wire having a first configuration when positioned within the sheath and a second configuration when deployed from the sheath, the wire having a sinuous shape in the second configuration and a straighter shape in the first configuration; and

rotating the wire so that peaks of the wire in the sinuous shape directly contact a wall of the lumen to break up the thrombotic material.

21. A method for performing a thrombectomy procedure to break up thrombotic material in a vascular graft which forms a shunt between an artery and a vein, the method comprising:

inserting an introducer sheath into the vascular graft;

providing a thrombectomy device having a flexible sheath extending in an axial direction, a wire positioned within the flexible sheath, a motor operatively connected to the wire, and at least one inflatable balloon connected to the flexible sheath, the wire and the flexible sheath being relatively movable in the axial direction so that the wire has a first configuration when positioned within the flexible sheath and a second configuration when deployed from the flexible sheath, the wire having a sinuous shape in the second configuration and a straighter shape in the first configuration;

inserting the thrombectomy device through the introducer sheath and into a vascular lumen;

inflating the at least one balloon to expand the balloon radially from the thrombectomy device;

deflating the balloon; and

actuating the motor to rotate the wire to enable peaks of the wire in the sinuous shape to contact a wall of the vascular graft to break up thrombotic material in the vascular graft.

22. The method of claim 21, wherein the step of actuating the thrombectomy device comprises exposing a rotatable wire and rotating the wire.

23. The method of claim 22, wherein the thrombectomy device includes a second balloon, and the method includes inflating the second balloon.