Devices and methods for delivering fluid to tissue during ablation therapy

• US 11,013,555 B2
• Filed: 07/31/2017
• Issued: 05/25/2021
• Est. Priority Date: 08/11/2016
• Status: Active Grant

• Current Assignee: Thermedical, Inc.
• Original Assignee: Thermedical, Inc.
• Inventors: Curley, Michael G., Eberl, Gregory R., Clevenger, Jason M., Howard, Michael T., Delly, Erik
• Primary Examiner(s): Peffley, Michael F
• Assistant Examiner(s): Zink, Amanda L
• Application Number:
  US15/663,929
• Publication Number:
  US 20180042669A1
• Time in Patent Office: 1,394 Days
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00744 Fluid flow
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

Devices and methods for delivering fluid to tissue during ablation therapy are described herein. An exemplary device can include an elongate body having an inner lumen, outlet ports, and an ablation element configured to heat tissue. A flow resistance of the elongate body can increase along a length of the elongate body containing the outlet ports in a proximal to distal direction. This can be accomplished by, for example, varying outlet port size or relative spacing, decreasing a cross-sectional area of the inner lumen through which fluid can flow using a flow diverter or tapered inner lumen sidewalls, or limiting a ratio between a total area of the outlet ports and a cross-sectional area of the inner lumen. Adjusting flow resistance of the elongate body can provide more uniform fluid distribution or a desired non-uniform distribution.

Claims

1. An ablation device, comprising:

an elongate body having a tissue-puncturing distal tip, an inner lumen, and a fluid delivery portion extending along a length of the elongate body, the fluid delivery portion having a plurality of outlet ports configured to deliver fluid from the inner lumen to tissue surrounding the elongate body; and

an ablation element configured to heat tissue surrounding the elongate body;

wherein the fluid delivery portion of the elongate body is configured such that less than about 70% by volume of fluid delivered to tissue is emitted from outlet ports disposed in a distal 25% of the fluid delivery portion.

2. The device of claim 1, wherein the fluid delivery portion is further configured such that less than about 55% by volume of fluid delivered to tissue is emitted from outlet ports disposed in a distal 25% of the fluid delivery portion.

3. The device of claim 1, wherein the fluid delivery portion is further configured such that less than about 70% by volume of fluid delivered to tissue is emitted from outlet ports disposed in a proximal 25% of the fluid delivery portion.

4. The device of claim 1, wherein the fluid delivery portion is further configured such that less than about 55% by volume of fluid delivered to tissue is emitted from outlet ports disposed in a proximal 25% of the fluid delivery portion.

5. The device of claim 1, wherein the fluid delivery portion is further configured such that less than about 70% by volume of fluid delivered to tissue is emitted from outlet ports disposed in a central 50% of the fluid delivery portion.

6. The device of claim 1, wherein the fluid delivery portion is further configured such that less than about 40% by volume of fluid delivered to tissue is emitted from outlet ports disposed in a distal 25% of the fluid delivery portion.

7. The device of claim 1, wherein the fluid delivery portion is further configured such that more than about 40% by volume of fluid delivered to tissue is emitted from outlet ports disposed in a proximal 25% of the fluid delivery portion.

8. The device of claim 1, wherein at least a distal portion of the elongate body is configured to be inserted into tissue.

9. The device of claim 8, wherein the fluid delivery portion extends along at least about 10% of a length of the elongate body configured to be inserted into tissue.

10. The device of claim 1, wherein the fluid delivery portion extends along at least about a distal 10% of a length of the elongate body.

11. The device of claim 1, wherein the fluid delivery portion extends along at least about a distal half of a length of the elongate body.

12. The device of claim 1, wherein the tissue-puncturing distal tip is a pointed tip.

13. The device of claim 1, further comprising a heating assembly disposed within the inner lumen of the elongate body that is configured to heat fluid as it passes through the inner lumen.

14. The device of claim 13, wherein the heating assembly is disposed proximal to the plurality of outlet ports.

15. The device of claim 1, wherein a ratio of a sum of an area of each of the plurality of outlet ports to an area of the inner lumen is less than 6:

1.

16. The device of claim 1, wherein a ratio of a sum of an area of each of the plurality of outlet ports to an area of the inner lumen is less than about 3:

1.

17. The device of claim 1, wherein a cross-sectional area of substantially all of the plurality of outlet ports decreases from a proximal end of the elongate body to a distal end of the elongate body.

18. The device of claim 1, wherein spacing between substantially all axially-aligned outlet ports increases from a proximal end of the elongate body to a distal end of the elongate body.

19. The device of claim 1, wherein at least one of the plurality of outlet ports has a non-circular shape.

20. The device of claim 1, wherein at least one of the plurality of outlet ports has a slot shape.

21. The device of claim 1, wherein the ablation element is a radio frequency electrode disposed along a length of the elongate body;

and

wherein the device includes at least one outlet port positioned at least partially beyond a boundary of the ablation element to deliver fluid to tissue immediately adjacent to the boundary of the ablation element.

22. The device of claim 1, wherein the elongate body includes tapered sidewalls that progressively increase in thickness from a proximal end to a distal end of the fluid delivery portion.

23. The device of claim 1, further comprising:

a flow diverter disposed within the inner lumen of the elongate body and extending along a length of the fluid delivery portion thereof;

wherein a diameter of the flow diverter increases from a proximal end thereof to a distal end thereof.

31. The device of claim 1, wherein the elongate body is non-porous and each of the plurality of outlet ports formed therein is a discrete outlet port extending through the elongate body into the inner lumen.

24. An ablation device, comprising:

an elongate body having a tissue-puncturing distal tip and an inner lumen;

means for delivering fluid from the inner lumen to tissue surrounding the elongate body; and

means for delivering ablative energy to tissue surrounding the elongate body;

wherein the means for delivering fluid is configured to deliver substantially uniform flow of fluid over a substantial portion of a length of the elongate body.

25. The device of claim 24, wherein the means for delivering fluid is configured to deliver substantially uniform flow of fluid over at least about a distal 10% of the length of the elongate body.

26. The device of claim 24, wherein the means for delivering fluid is configured to deliver substantially uniform flow of fluid over at least about a distal 50% of the length of the elongate body.

27. The device of claim 24, wherein the means for delivering fluid is configured to deliver substantially uniform flow of fluid over substantially all of the length of the elongate body.

28. The device of claim 24, wherein a portion of the length of the elongate body configured to be inserted into tissue includes the substantial portion of the length of the elongate body configured to deliver substantially uniform flow of fluid.

29. An ablation device, comprising:

an elongate body having a tissue-puncturing distal tip;

means for delivering fluid to tissue surrounding the elongate body; and

an ablation element configured to heat tissue surrounding the elongate body;

wherein the means for delivering fluid is configured to deliver substantially uniform flow of fluid over a portion of a length of the elongate body configured to be inserted in tissue.

30. The device of claim 29, wherein the portion of the length of the elongate body configured to be inserted in tissue includes at least about a distal 10% of a length of the elongate body.