ROBOTIC ABLATION CATHETER

• US 20090254083A1
• Filed: 03/10/2009
• Published: 10/08/2009
• Est. Priority Date: 03/10/2008
• Status: Abandoned Application

• Current Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Original Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Inventors: Murphy, Sean, Lee, Katherine Whitin, Yee, William K., Wallace, Daniel T., Schlesinger, Randall L., Schultheis, Eric A.
• Application Number:
  US12/401,588
• Publication Number:
  US 20090254083A1
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 34/35 for telesurgery
• CPC Class Codes: A61B 34/71 Manipulators operated by drive cable mechanisms

Abstract

Assemblies, systems, and methods related to remotely-steerable ablation procedures are described. A necked-down ablation catheter may be coupled within a working lumen of a robotically-steerable sheath configured to be driveably coupled to an electromechanical instrument driver. The ablation catheter may be an irrigated ablation catheter having an irrigation fluid reservoir at its distal tip. The outer diameter of the distal portion of the ablation catheter is generally larger than that of the more proximal aspects due, in part, to the fact that the proximal aspects are designed to fit through a relatively low-profile steerable sheath.

Claims

1. An ablation instrument system, comprising:

a. a robotically-steerable sheath having proximal and distal ends and defining a working lumen between said ends; and

b. a necked-down ablation catheter having a distal ablation tip, a proximal end, and a tubular body coupling the distal ablation tip and the proximal end;

wherein at least a portion of the tubular body is slideably disposed through the working lumen of the robotically-steerable sheath; and

wherein the distal ablation tip has an outer diameter configured to prevent such tip from fitting into the working lumen of the sheath.

2. The instrument system of claim 1, wherein the distal ablation tip and tubular body are coupled with a substantially stepwise neckdown.

3. The instrument system of claim 2, wherein the distal ablation tip has a substantially cylindrical side outer shape with a substantially flat distal face.

4. The instrument system of claim 2, wherein the distal ablation tip has a substantially cylindrical side outer shape with a substantially hemispherical distal face.

5. The instrument system of claim 2, wherein the distal ablation tip has a substantially spherical outer shape.

6. The instrument system of claim 2, wherein the distal ablation tip has a substantially cylindrical side outer shape with a substantially bullet-shaped distal face.

7. The instrument system of claim 1, wherein the ablation catheter comprises a first irrigation lumen defined between the proximal end and the distal tip.

8. The instrument system of claim 7, wherein the distal tip comprises thin-shell design comprising sidewalls having a sidewall thickness, a distal face having a distal face thickness, and defining a distal irrigation reservoir volume defined between the sidewalls, distal face, and a proximal surface of the distal ablation tip, the irrigation reservoir volume being accessible via the first irrigation lumen.

9. The instrument system of claim 8, wherein the outer diameter of the distal tip is at least four times greater than the sidewall thickness.

10. The instrument system of claim 8, wherein the distal face has a substantially uniform thickness.

11. The instrument system of claim 10, wherein the distal face thickness is at least two times greater than the sidewall thickness.

12. The instrument system of claim 8, wherein the distal face has an inner surface defining a distal portion of the distal irrigation reservoir volume, the distal face inner surface having a channeled geometry to maximize surface area of the distal face inner surface.

13. The instrument system of claim 8, further comprising a metallic heat sink member suspended within the distal irrigation reservoir volume.

14. The instrument system of claim 13, wherein the metallic heat sink member has a surface shape at least partially defining channels configured to maximize surface engagement between the metallic heat sink member and fluids which may be present in the distal irrigation reservoir volume.

15. The instrument system of claim 8, wherein a plurality of sideholes are defined through the sidewalls to allow for the escape of irrigation fluids pressurized into the distal irrigation reservoir volume.

16. The instrument system of claim 8, the ablation catheter further comprising a return irrigation lumen defined between the proximal end and the distal tip and configured to allow at least a portion of fluid pressurized through the first irrigation lumen to the irrigation reservoir volume to return to the proximal end of the ablation catheter.

17. The instrument system of claim 7, wherein the necked-down ablation catheter comprises at least one electrical lead coupled between the distal ablation tip and the proximal end, and a proximal quick connect interface configured to allow coupling of an electrical source to the at least one electrical lead as well as coupling of an irrigation source to the first irrigation lumen with manual actuation of a single mechanical coupling.

18. A method of conducting a minimally invasive ablation procedure, comprising:

a. coupling a necked-down ablation catheter through a working lumen of a robotically-steerable sheath by threading a proximal end of the ablation catheter into the lumen through a distal end of the sheath and continuing to advance the ablation catheter relative to the sheath until the proximal end of the ablation catheter at least partially emerges from a proximal end of the sheath;

b. connecting an RF energy source and an irrigation fluid source to the proximal end of the ablation catheter;

c. coupling at least the robotically-steerable sheath to an electromechanical instrument driver;

d. inserting at least the distal ends of the coupled ablation catheter and robotically-steerable sheath into a patient; and

e. utilizing the electromechanical instrument driver to navigate the distal end of the sheath and thereby navigate the distal end of the ablation catheter.

19. The method of claim 18, wherein connecting an RF energy source and an irrigation fluid source to the proximal end of the ablation catheter comprises actuating a proximal quick connect interface configured to allow coupling of the RF energy source to at least one electrical lead on the ablation catheter as well as coupling of the irrigation fluid source to a first irrigation lumen defined by the ablation catheter, with manual actuation of a single mechanical coupling.

20. The method of claim 18, wherein inserting comprises commanding the electromechanical instrument driver to insert the coupled ablation catheter and steerable sheath.

21. The method of claim 18, further comprising advancing irrigation fluid from a proximally disposed reservoir to a reservoir disposed within the distal end of the ablation catheter.

22. The method of claim 21, further comprising disbursing at least a portion of said irrigation fluid out of the distal end of the ablation catheter through a plurality of side ports.

23. The method of claim 21, further comprising returning at least a portion of the advanced irrigation fluid from the distal end of the ablation catheter to the proximal end of the ablation catheter via a return irrigation lumen.

24. A method, comprising:

a. inserting a distal portion of an elongate instrument into a patient'"'"'s body, the elongate instrument comprising a necked down ablation catheter having a distal ablation tip, a proximal end, and a tubular body coupling the distal ablation tip and the proximal end, wherein at least a portion of the tubular body is slideably disposed through the working lumen of a robotically-steerable sheath and the outer diameter of the distal ablation tip is greater than the inner diameter of the sheath defining the working lumen; and

b. dithering the elongate instrument relative to the sheath.

25. The method according to claim 24, further comprising:

a. advancing the distal tip of the necked down ablation catheter into contact with a tissue structure surface within the patient'"'"'s body; and

b. calculating loads imparted to the distal tip of the necked down ablation catheter as a result of such contact.

26. The method according to claim 25, wherein calculating comprises measuring relative loads between the necked down ablation catheter and sheath during the dithering.