Sheath And Method Of Use

• US 20110306970A1
• Filed: 06/14/2011
• Published: 12/15/2011
• Est. Priority Date: 06/14/2010
• Status: Active Grant

• Current Assignee: Texas Heart Institute
• Original Assignee: Texas Heart Institute
• Inventors: Razavi, Mehdi
• Granted Patent: US 9,474,881 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• 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;

deploying a catheter within the first lumen;

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 ablating the tissue with the catheter while removing the fluid via the second lumen.

3. The method of claim 1 including stabilizing the sheath against additional tissue by applying negative pressure, relative to pressure inside the patient'"'"'s body nearby the catheter, to a fenestration included in the sheath.

4. The method of claim 1 including:

(a) ablating the tissue with the catheter; and

(b) after step (a), removing the fluid via the second lumen; and

(c) after step (b), ablating additional tissue with the catheter; and

wherein steps (a), (b), and (c) are performed sequentially without removing the catheter from the first lumen during or between any of steps (a), (b), and (c).

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

6. The method of claim 1 including removing the fluid via multiple fenestrations included in the second lumen.

7. The method of claim 1 including:

deploying the catheter within the patient'"'"'s pericardial space;

ablating the tissue with the catheter, wherein the tissue is included in 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 including repeatedly, without removing the catheter from the first lumen, both (a) ablating tissue with the catheter;

and (b) removing fluid via the second lumen;

wherein the tissue is included in the pericardial space.

10. The method of claim 1, wherein the sheath includes first and second fenestrations included entirely between, but separate from, the proximal and distal ends of the sheath, the method further including:

applying negative pressure, relative to pressure inside the body nearby the catheter, to the first fenestration but not the second fenestration; and

then

applying negative pressure, relative to pressure inside body nearby the catheter, to the second fenestrations but not the first fenestration.

12. The method of claim 1 including navigating the sheath within a patient'"'"'s pericardial space based on applying negative pressure, relative to pressure inside the body nearby the catheter, to a fenestration included in the sheath.

13. The method of claim 1 including simultaneously (a) ablating the tissue with the catheter, (b) removing the fluid via the second lumen, and (c) irrigating an area near the tissue.

14. The method of claim 13 including irrigating the area near the tissue via a third lumen included in the sheath.

11. The method of claim 11 including stabilizing the sheath against additional tissue by applying the negative pressure to the first fenestration.

15. An apparatus comprising:

a sheath having first and second lumens;

wherein the first lumen is configured to receive a catheter that ablates tissue and the second lumen is configured to remove fluid while the catheter is deployed within the first lumen.

16. The apparatus of claim 15, wherein the first and second lumens are configured to allow simultaneous tissue ablation with the catheter and fluid removal with the second lumen.

17. The apparatus of claim 15, wherein the distal end of the sheath includes a maximum outer diameter no greater than 12 French.

18. The apparatus of claim 15, wherein a distal end of the second lumen is closed and a side wall of the second lumen includes first and second fenestrations to allow fluid exchange between the second lumen and a patient.

19. The apparatus of claim 15, wherein a first portion of a side wall of the second lumen, the first portion being proximal to the distal end of the second lumen, includes a plurality of fenestrations.

20. The apparatus of claim 19, wherein no second portion of any side wall of the first lumen, the second portion being proximal to the distal end of the first lumen, includes a fenestration.