Devices and methods for remote temperature monitoring in fluid enhanced ablation therapy

• US 10,548,654 B2
• Filed: 03/06/2017
• Issued: 02/04/2020
• Est. Priority Date: 04/12/2011
• Status: Active Grant

• Current Assignee: Thermedical, Inc.
• Original Assignee: Thermedical, Inc.
• Inventors: Curley, Michael G.
• Primary Examiner(s): Wu, Eugene T
• Application Number:
  US15/450,806
• Publication Number:
  US 20170238993A1
• Time in Patent Office: 1,065 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 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00773 Sensed parameters
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00809 measured thermochromatically
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/162 located on the probe body
• CPC Class Codes: F04B 17/03 driven by electric motors
• CPC Class Codes: F04B 19/22 of reciprocating-piston type
• CPC Class Codes: F04B 41/02 having reservoirs
• CPC Class Codes: F04B 43/04 : Pumps having electric drive
• CPC Class Codes: F04B 49/06 : Control using electricity regulating by means of floats actuating electric switches F04B49/04
• CPC Class Codes: F04C 2270/041 : Controlled or regulated
• CPC Class Codes: Y10T 29/49016 : Antenna or wave energy "plumbing" making
• CPC Class Codes: Y10T 29/49085 : Thermally variable

Abstract

Devices and methods for monitoring the temperature of tissue at various locations in a treatment volume during fluid enhanced ablation therapy are provided. In one embodiment, an ablation device is provided having an elongate body, at least one ablation element, and at least one temperature sensor. The elongate body includes a proximal and distal end, an inner lumen, and at least one outlet port to allow fluid to be delivered to tissue surrounding the elongate body. The at least one ablation element is configured to heat tissue surrounding the at least one ablation element. The at least one temperature sensor can be positioned a distance away from the at least one ablation element and can be effective to output a measured temperature of tissue spaced a distance apart from the at least one ablation element such that the measured temperature indicates whether tissue is being heating to a therapeutic level.

Claims

1. An ablation device, comprising:

an elongate body having an inner lumen configured to deliver fluid to tissue surrounding the elongate body through at least one outlet port formed in the elongate body when the elongate body is introduced into a tissue mass;

at least one ablation element configured to heat tissue within a treatment zone surrounding the elongate body;

a plurality of temperature sensors coupled to the elongate body such that each sensor contacts a sidewall of the elongate body, the plurality of temperature sensors being positioned axially along the elongate body such that each of the plurality of temperature sensors is a distance apart from the at least one ablation element and is effective to output a measured temperature of tissue spaced a distance apart from tissue adjacent to the at least one ablation element such that the measured temperature indicates whether tissue is being heating to a therapeutic level;

an insulating tube extending through the inner lumen of the elongate body, wherein the insulating tube contains the fluid flowing through the inner lumen and prevents the fluid from contacting the sidewall of the elongate body; and

a fluid heating assembly disposed within the insulating tube, the fluid heating assembly including one or two wires configured to heat surrounding fluid, the one or two wires extending through at least one spacer disposed within the insulating tube.

2. The ablation device of claim 1, wherein the insulating tube includes a plurality of lumens formed in a sidewall of the insulating tube that surround a central lumen configured to carry the fluid.

3. The ablation device of claim 1, wherein the insulating tube includes a plurality of tabs running longitudinally along the tube and extending laterally therefrom to prevent a sidewall of the insulating tube from contacting the elongate body.

4. The ablation device of claim 1, wherein the plurality of temperature sensors are positioned proximal to the at least one ablation element.

5. The ablation device of claim 1, wherein the plurality of temperature sensors are positioned distal to the at least one ablation element.

6. The ablation device of claim 1, wherein each of the plurality of temperature sensors is positioned at a different distance from the at least one ablation element than a remainder of the plurality of temperature sensors.

7. The ablation device of claim 1, wherein the at least one ablation element comprises a first ablation element and a second ablation element positioned distal to the first ablation element, and the elongate body further includes:

a baffling element disposed within the inner lumen between the first and second ablation elements, the baffling element dividing the inner lumen into a first section proximal of the baffling element and a second section distal of the baffling element; and

a plurality of cannulas extending from a proximal end of the elongate body through the baffling element to allow delivery of separate fluids to each section of the inner lumen.

8. The ablation device of claim 7, wherein the plurality of temperature sensors includes a first plurality of temperature sensors disposed proximal to the first ablation element and a second plurality of temperature sensors disposed distal to the second ablation element.

9. The ablation device of claim 1, wherein the plurality of temperature sensors comprises a first plurality of temperature sensors positioned distal of the at least one ablation element, and a second plurality of temperature sensors positioned proximal of the at least one ablation element.

10. The ablation device of claim 1, wherein the plurality of temperature sensors are located on an outer surface of the elongate body.

11. The ablation device of claim 1, wherein the plurality of temperature sensors are located in the inner lumen of the elongate body.

12. The ablation device of claim 1, wherein the plurality of temperature sensors are each located in a recess formed in the elongate body.

13. The ablation device of claim 1, wherein the plurality of temperature sensors are each thermally isolated from the elongate body.

14. The ablation device of claim 1, wherein a position of at least one of the plurality of temperature sensors is adjustable along a length of the elongate body.

15. The ablation device of claim 1, wherein at least one of the plurality of temperature sensors comprises a thermocouple.

16. A system for delivering saline enhanced ablation, comprising:

an elongate body having an inner lumen and at least one outlet port;

at least one ablation element configured to heat tissue adjacent to the elongate body;

a fluid source in communication with the inner lumen of the elongate body and configured to deliver fluid through the inner lumen such that the fluid can flow through the at least one outlet port and be delivered to tissue;

a plurality of temperature sensors coupled to the elongate body such that each sensor contacts a sidewall of the elongate body, the plurality of temperature sensors being positioned axially along the elongate body such that each of the plurality of temperature sensors is a distance apart from the at least one ablation element and is effective to measure a temperature of tissue spaced a distance apart from tissue adjacent to the at least one ablation element;

an insulating tube extending through the inner lumen of the elongate body, wherein the insulating tube contains the fluid flowing through the inner lumen and prevents the fluid from contacting the sidewall of the elongate body;

a fluid heating assembly disposed within the insulating tube, the fluid heating assembly including one or two wires configured to heat surrounding fluid, the one or two wires extending through at least one spacer disposed within the insulating tube; and

a control unit configured to obtain a temperature of the at least one ablation element and a plurality of temperatures measured by the plurality of temperature sensors;

wherein the plurality of temperatures measured by the plurality of temperature sensors indicate whether tissue within a treatment zone is being heated to a therapeutic level.

17. The system of claim 16, wherein the insulating tube includes a plurality of lumens formed in a sidewall of the insulating tube that surround a central lumen configured to carry the fluid.

18. The system of claim 16, wherein the insulating tube includes a plurality of tabs running longitudinally along the tube and extending laterally therefrom to prevent a sidewall of the insulating tube from contacting the elongate body.

19. The system of claim 16, wherein the control unit is configured to adjust at least one of a flow rate of the fluid flowing through the elongate body, an ablative energy level of the ablation element, and a temperature of the fluid being delivered in response to the plurality of temperatures measured by the plurality of temperature sensors.