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

• US 6,312,444 B1
• Filed: 04/12/2000
• Issued: 11/06/2001
• 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): Reip, David O.
• Assistant Examiner(s): NGO, LIEN M
• Application Number:
  US09/547,951
• Time in Patent Office: 573 Days
• Field of Search: 606/200, 606/192, 606/196, 606/197, 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 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 at least one perfusion port proximal to the occluder and communicating with a perfusion lumen;

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

perfusing oxygenated medium into the artery through the perfusion port.

2. The method of claim 1, wherein the carotid artery is the common carotid artery.

3. The method of claim 1, wherein the carotid artery is selected from the group consisting of the internal carotid artery and carotid siphon.

4. The method of claim 1, wherein the artery is the middle cerebral artery.

5. The method of claim 1, wherein the artery is the anterior cerebral artery.

6. The method of claim 1, wherein the occluder is a balloon which communicates with an inflation lumen.

7. The method of claim 1, wherein the catheter further comprises a chopping mechanism.

8. The method of claim 1, wherein a plurality of perfusion ports are located on first and second concentric cylindrical members.

9. The method of claim 8, wherein the perfusion ports on the first member align with the perfusion ports on the second member by relative rotation of the first and second members.

10. The method of claim 9, further comprising the step of controlling the perfusion rate of oxygenated medium into the artery by relative rotation of the first and second members.

11. The method of claim 1, wherein the catheter further comprises a second balloon occluder proximal the perfusion port.

12. The method of claim 1, wherein the oxygenated medium is hypothermic.

13. The method of claim 1, further comprising the step of infusing pharmaceutical agent into the carotid artery through the aspiration port.

14. The method of claim 13, wherein the pharmaceutical agent is a vasodilator.

15. The method of claim 14, wherein the vasodilator is selected from the group consisting of nifedipine and nitroprusside.

16. The method of claim 13, wherein the pharmaceutical agent is t-PA.

17. The method of claim 1, further comprising the step of localizing the thromboembolic material with intravascular ultrasound.

18. The method of claim 1, further comprising the step of localizing the thromboembolic material with carotid doppler.

19. The method of claim 1, further comprising the step of localizing the atheroma and establishing the direction of flow with transcranial doppler.

20. The method of claim 1, where in the oxygenated medium is blood.