Multi-functional thrombectomy device

• US 7,645,290 B2
• Filed: 05/05/2005
• Issued: 01/12/2010
• Est. Priority Date: 05/05/2005
• Status: Active Grant

• Current Assignee: Paul R. Lucas
• Original Assignee: Paul R. Lucas
• Inventors: Lucas, Paul R.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Tanner; Jocelin C
• Application Number:
  US11/122,032
• Publication Number:
  US 20060253145A1
• Time in Patent Office: 1,713 Days
• Field of Search: 606/127, 606/128, 606/113, 606/159, 606/167, 606/169, 606/170, 606/171, 606/180, 606/192, 606/194, 606/198, 606/200, 604/96.01, 604/158, 604/164.01, 604/171, 604/172, 604/181, 604/264, 604/509, 604/22, 604/19, 604/523, 604/533
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• 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 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• 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: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy

Abstract

A hand held motor powered device for percutaneous thrombolysis and evacuation of a clot from a clotted arterio-venous fistula is disclosed. The percutaneous thrombectomy device is provided with a plurality of nested coaxial lubricious catheters. The multi-functional thrombectomy device can simultaneously and sequentially degrade and evacuate a blood clot from a blood vessel by multiple modalities that combines to degrade the clot by mechanical agitation, fragmentation and disruption, by peri-thrombus delivery of enzymatic fluids, by irrigation with biocompatible fluids, and by balloon displacement. The thrombectomy device further provides for balloon containment and isolation of clot debris from the general circulation, thereby minimizing the risks to a patient of embolic sequelae. There is also provided an optional steering mechanism for controlled deflection of the working end of the device.

Claims

1. A medical percutaneous thrombectomy device for removal of a clot from a blood vessel, comprising:

(a) a handle housing having a through conduit longitudinally formed therein for slidingly receiving therethrough a guidewire and provided with an actuating mechanism fixedly located through a surface of said handle housing;

(b) a control housing protruding from and slidably positioned within said handle housing, having a pair of irrigation catheters mounted to said control housing being linearly displaceable within a recess formed through a wall of said handle housing, and adapted for longitudinal displacement relative to said handle housing;

(c) a tined catheter having a balloon catheter extending therethrough, said tined catheter having a plurality of tines and a fusiform tip member fixedly mounted thereto and contiguous a distal end of an evacuation catheter when said medical percutaneous thrombectomy device is in an undeployed state wherein said plurality of tines are contained within said evacuation catheter and displaced from said distal end of evacuation catheter when said medical percutaneous thrombectomy device is in a deployed state, said fusiform tip member having a base diameter substantially equal to an outer diameter of said evacuation catheter in said undeployed state, said tined catheter being longitudinally secured and undisplaceable relative to said handle housing and rotatably seated within said through conduit, distally protruding through said handle housing and said control housing, being rotationally coupled at a proximal end to a motor housed in said handle housing; and

,

(d) a plurality of coaxially positioned catheters positioned over said balloon catheter through said control housing, said coaxially positioned catheters including said evacuation catheter, an infusion catheter, and said tined catheter,

wherein said balloon catheter has a balloon mounted on a distal end of said balloon catheter, at least one of said catheters having at least one of a plurality of thrombectomy modalities, providing for fragmentation of said clot wherein said balloon is positioned distal to said clot for preventing fragments of said clot from being displaced distal to said balloon within said blood vessel; and

wherein said evacuation catheter and said infusion catheter are slidably positioned over said tined catheter and said balloon catheter.

2. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 1 with said plurality of thrombectomy modalities further comprising a fragmentation mechanism including said plurality of tines for mechanical agitation, shearing, and disruption of a clot within a vascular structure.

3. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 1, with said plurality of thrombectomy modalities includes at least one reversibly inflatable member defining said balloon for isolating a plurality of clot fragments of said clot from entering a vascular circulation wherein one of said irrigation catheters is provided with an infusion port to infuse a biocompatible fluid in an effective proximity to said clot, and an evacuation port to remove said fluid with said plurality of clot fragments contained therein.

4. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 1 wherein said guidewire has a length greater than a longitudinal length of said thrombolytic device, said guidewire being external to said device and inserted into and through said through conduit, said through conduit being positioned coaxially central to a plurality of successive longitudinal segments of the respective plurality of coaxially positioned catheters.

5. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 1 wherein said balloon catheter is positioned within said catheters and surrounding said guidewire having said balloon secured thereon and further provided proximally with at least one inflation port with a valve for reversibly filling said balloon with a fluid under pressure.

6. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 4 having a balloon catheter length substantially equal to said guidewire length.

7. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 2, wherein said fragmentation mechanism comprises said plurality of tines that are radially expandable and resilient, formed on a distal end of said tine catheter.

8. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 3, wherein said biocompatible fluid comprises at least one active species for biochemically degrading said clot.

9. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 3, wherein said biocompatible fluid comprises at least one active species for enzymatically degrading said clot.

10. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 7, having a deployed condition and an undeployed condition, wherein said device is in the deployed condition when said control housing is longitudinally displaced proximally to a reversibly complementary juxtaposition with said handle housing thereby reversibly uncovering said plurality of tines and allowing said plurality of tines to expand radially.

11. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 10 wherein a change is effected between a deployed condition and an undeployed condition by a displacing guard member pivotally attached to said handle housing, wherein said displacing guard member has a closed position for obstructing an access to an activation member, and upon pivotal displacement assumes an open position that allows access to said activation member, said displacement guard being attached to said control housing so as to effect a longitudinal displacement with respect to said handle housing.

12. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 1, further comprising a control wheel rotatably mounted on said handle housing and connected to said fusiform tip member formed on a distal end of said tined catheter, wherein rotation of said control wheel causes a responsive displacement of said plurality of coaxially positioned catheters.

13. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 2 wherein said fragmentation mechanism comprises at least three tines formed at regular intervals on a distal end of said tined catheter.

14. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 1 wherein said plurality of coaxially positioned catheters comprises said infusion catheter coaxially positioned around said evacuation catheter, each of said catheters proximally fixed to said control housing and extending therethrough and terminating proximally with a catheter connector formed at a proximal opening of each of said catheters to reversibly couple said catheters to a plurality of standard fluid conduits, said catheters further including an opening formed in a catheter outer surface located in longitudinal alignment with said through conduit and hermetically sealed with an elastomeric member having a self-sealing aperture centrally positioned and adapted to accept therethrough said guidewire and said balloon catheter and maintain a fluid-tight seal.

15. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 14 wherein each of said plurality of coaxially positioned catheters is provided with a lubricious coating.

16. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 1 wherein said tined catheter is provided with a lubricious coating.

17. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 1 wherein a motor is electrically connected to a battery housed within said handle housing and actuated by said actuating member.

18. The medical percutaneous thrombectomy device for removal of a clot from a blood vessel as recited in claim 17 wherein said motor is powered by an external power source and actuated by said actuating member.