Sheath and method of use

• US 9,474,881 B2
• Filed: 06/14/2011
• Issued: 10/25/2016
• Est. Priority Date: 06/14/2010
• Status: Active Grant

• Current Assignee: Texas Heart Institute
• Original Assignee: Texas Heart Institute
• Inventors: Razavi, Mehdi
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): ZINK, AMANDA L
• Application Number:
  US13/160,219
• Publication Number:
  US 20110306970A1
• Time in Patent Office: 1,960 Days
• Field of Search: 606 35- 48
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00363 Epicardium
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

In an embodiment a sheath allows one to simultaneously ablate tissue, using a catheter located in the sheath, and remove fluid from a patient'"'"'s pericardial space, via the same sheath, all without withdrawing the ablation catheter from the sheath. Applying pressure (positive or negative) to fenestrations in the sheath may allow one to withdraw fluid from the space, navigate the sheath within the space, and/or adhere the sheath to tissue in the space. Other embodiments are described herein.

Claims

1. A method comprising:

providing a sheath having first and second lumens and first and second fenestrations, wherein the first and second fenestrations are included entirely between, but separate from, proximal and distal ends of the sheath;

deploying a catheter within the first lumen;

applying negative pressure to the first fenestration but not the second fenestration;

applying negative pressure to the second fenestration but not the first fenestration;

ablating patient tissue with the catheter; and

removing patient fluid via the second lumen while the catheter is deployed within the first lumen.

2. The method of claim 1 including simultaneously performing:

(a) the ablating the patient tissue with the catheter and (b) the removing the patient fluid via the second lumen.

3. The method of claim 1 including stabilizing the sheath against the patient tissue by applying negative pressure to at least one of the first and second fenestrations.

4. The method of claim 1 comprising again ablating the patient tissue with the catheter;

wherein;

(a) the ablating the patient tissue with the catheter;

(b) the removing the patient fluid via the second lumen; and

(c) the again ablating the patient tissue with the catheter are performed without removing the catheter from the first lumen during or between any of the ablating the patient tissue with the catheter, the removing the patient fluid via the second lumen, and the again ablating the patient tissue with the catheter.

5. The method of claim 1 including irrigating an area near the patient tissue via the second lumen.

6. The method of claim 1, wherein:

the second lumen includes multiple fenestrations including two or more of the first fenestration, the second fenestration, and additional fenestrations;

the removing the patient fluid via the second lumen includes removing the patient fluid via the multiple fenestrations.

7. The method of claim 1, wherein the patient tissue is included in a pericardial space, the method including:

deploying the catheter within the pericardial space.

8. The method of claim 1 including monitoring a cardiac biosignal via an electrode fixedly connected to the sheath and separate from the catheter.

9. The method of claim 1, wherein the patient tissue is included in a pericardial space, the method including repeatedly, without removing the catheter from the first lumen, both (a) ablating the patient tissue with the catheter;

and (b) removing the patient fluid via the second lumen.

10. The method of claim 1 including stabilizing the sheath against the patient tissue by applying negative pressure to the first fenestration.

11. The method of claim 1, wherein the patient tissue is included in a pericardial space, the method including navigating the sheath within the a pericardial space based on applying negative pressure to the first fenestration.

12. The method of claim 1 including irrigating an area near the patient tissue and simultaneously performing:

(a) the ablating the patient tissue with the catheter, (b) the removing the patient fluid via the second lumen, and (c) the irrigating the area near the patient tissue.

13. The method of claim 12 wherein the irrigating the area near the patient tissue includes irrigating the area near the patient tissue via a third lumen included in the sheath.

14. A method comprising:

providing a sheath having first and second lumens;

deploying a catheter within the first lumen but not the second lumen;

stabilizing the sheath against patient tissue by applying negative pressure to a fenestration included in a lateral wall of the sheath;

ablating the patient tissue with the catheter emerging from a distal end portion of the sheath; and

removing patient fluid via the second lumen while the catheter is deployed within the first lumen.

15. The method of claim 14 including stabilizing the sheath directly against the patient tissue by applying negative pressure to the fenestration to directly contact the sheath to the patient tissue;

wherein the catheter moves independently of the sheath.

16. The method of claim 14 including irrigating the patient tissue with a fluid that directly contacts an inner wall of the second lumen.

17. The method of claim 14 including irrigating the patient tissue via a third lumen included in the distal end portion of the sheath.

18. The method of claim 14, wherein the lateral wall couples the distal end portion of the sheath to a proximal end portion of the sheath and the lateral wall is orthogonal to the distal end portion.