Medical device for removing thromboembolic material from cerebral arteries and methods of use

• US 6,165,199 A
• Filed: 01/12/1999
• Issued: 12/26/2000
• Est. Priority Date: 01/12/1999
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Coaxis Incorporated (Trimble Inc.)
• Inventors: Barbut, Denise
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): NGO, LIEN M
• Application Number:
  US09/228,718
• Time in Patent Office: 714 Days
• Field of Search: 606/200, 606/192, 606/194, 606/195, 606/159, 606/160, 604/96, 604/97, 604/101, 604/19, 604/22
• US Class Current: 606/200
• 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 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material

Abstract

The invention provides a medical device having an elongate catheter, a balloon occluder mounted on a distal end of the catheter, and optionally a chopping mechanism associated with an aspiration port of the catheter. Continuous or intermittent suction can be applied to the aspiration port which is distal to the occluder to dislodge thromboembolic material in a carotid or cerebral artery. Oxygenated blood or other fluid, which may be hypothermic, can be perfused through at least one perfusion port proximal to the occluder to maintain and augment perfusion of the collateral vasculature proximal to the occlusive lesion. The flow rate of blood or fluid can be controlled by rotating two cylindrical members. Neuroprotective agents or t-PA can also be infused distal to the occluder through the aspiration port or an infusing port. Methods of using the devices in treating patients with acute stroke or occlusive cerebrovascular disease are also disclosed.

Claims

1. A medical device for removing thromboembolic material from a carotid artery or any other extracranial or intracranial artery, comprising:

an elongate catheter having a proximal end, a distal end, and a lumen therebetween communicating with an aspiration port at the distal end, the catheter further comprising first and second concentric cylindrical members and a perfusion lumen communicating with one or more perfusion ports, whereby relative rotation of the first and second members causes the perfusion ports on the first member to align with the perfusion ports on the second member;

a balloon occluder mounted on the distal end of the catheter proximal the aspiration port and distal the one or more perfusion ports; and

a chopping mechanism associated with the aspiration port, wherein thromboembolic material engaged by suction through the aspiration port is chopped and aspirated through the catheter.

2. The medical device of claim 1, wherein the balloon occluder comprises an elastomeric balloon.

3. The medical device of claim 1, wherein the balloon occluder communicates with a balloon inflation lumen.

4. The medical device of claim 1, wherein the proximal end of the catheter is adapted for attachment to a vacuum.

5. The medical device of claim 1, wherein the aspiration port and lumen are adapted for infusion of fluid, blood, and pharmaceutical agents.

6. The medical device of claim 5, wherein the pharmaceutical agent is a vasodilator.

7. The medical device of claim 6, wherein the vasodilator is selected from the group consisting of nifedipine and nitroprusside.

8. The medical device of claim 5, wherein the pharmaceutical agent is t-PA.

9. The medical device of claim 1, further comprising an additional lumen and port for infusion of blood and pharmaceutical agent.

10. The medical device of claim 1, further comprising a manometer distal to the balloon occluder.

11. The medical device of claim 1, wherein the chopping mechanism comprises an abrasive grinding surface.

12. The medical device of claim 1, wherein the chopping mechanism comprises a rotatable blade which operates within a housing.

13. The medical device of claim 12, wherein the catheter further comprises a second balloon occluder proximal the perfusion ports.

14. A method for removing thromboembolic material from a carotid or cerebral artery, comprising the steps of:

providing a catheter having a proximal end, a distal end, an expandable occluder mounted on the distal end, an aspiration port distal the occluder, an aspiration lumen communicating with the port, and a chopping mechanism;

inserting the distal end of the catheter into the artery;

expanding the occluder to occlude the artery;

applying a negative pressure to the aspiration port, wherein the thromboembolic material is engaged by the port; and

operating the chopping mechanism to remove at least a portion of the thromboembolic material.

15. The method of claim 14, wherein the carotid artery is the common carotid artery.

16. The method of claim 14, wherein the carotid artery is selected from the group consisting of the internal carotid artery and carotid siphon.

17. The method of claim 14, wherein the artery is the middle cerebral artery.

18. The method of claim 14, wherein the artery is the anterior cerebral artery.

19. The method of claim 14, wherein the occluder is a balloon which communicates with an inflation lumen.

20. The method of claim 14, wherein the catheter further comprises an additional lumen and port for infusion of blood and pharmaceutical agent.

21. The method of claim 14, wherein chopping mechanism comprises an abrasive grinding surface.

22. The method of claim 14, wherein the chopping mechanism comprises a rotatable blade which operates within a housing.

23. The method of claim 14, further comprising the step of infusing pharmaceutical agent into the carotid artery through the aspiration port.

24. The method of claim 23, wherein the pharmaceutical agent is a vasodilator.

25. The method of claim 24, wherein the vasodilator is selected from the group consisting of nifedipine and nitroprusside.

26. The method of claim 23, wherein the pharmaceutical agent is t-PA.

27. The method of claim 14, further comprising the step of localizing the atheroma with intravascular ultrasound.

28. The method of claim 14, further comprising the step of localizing the thromboembolic material with carotid doppler.

29. The method of claim 14, further comprising the step of localizing the thromboembolic material and direction of flow with transcranial doppler.