METHODS AND SYSTEMS FOR USE IN CONTROLLING TISSUE ABLATION VOLUME BY TEMPERATURE MONITORING

• US 20140350542A1
• Filed: 08/06/2014
• Published: 11/27/2014
• Est. Priority Date: 03/27/2012
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: KRAMER, Steve, KAMDAR, Kirti P., KOHM, Andrew, POSER, Robert, GERMAIN, Aaron
• Granted Patent: US 10,028,784 B2
• Time in Patent Office: Days
• US Class Current: 606/34
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00684 using lookup tables
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration

Abstract

This invention relates to medical methods, instruments and systems for creating a controlled lesion using temperature to control the growth of the lesion. The treatment can be used in any tissue area and is particularly useful in or around a vertebral body. The features relating to the methods and devices described herein can be applied in any region of soft or hard tissue including bone or hard tissue.

Claims

1. A medical device for creating regions of heated tissue using temperature to monitor a desired profile of the regions, the medical device, comprising:

a shaft coupled to a handle, where the handle includes a connector for electrically coupling to an energy controller;

a first temperature detecting element spaced axially proximally along the shaft from a proximal end of the energy transfer portion;

a second temperature detecting element spaced proximally from the first temperature detecting element;

where the first and second temperature detecting elements are configured to independently and respectively provide a first and a second actual temperature measurements; and

where the energy controller delivers energy to the energy transfer portion and is configured to control energy delivery compares the at least the first or second actual temperature measurements to at least one associated temperature to produce a heated tissue having a known profile.

2. The device of claim 1, where the shaft includes an articulating portion where the energy transfer portion is located distally to the articulating portion.

3. The device of claim 1, the shaft and the handle are configured to receive an impact force applied on the handle and transfer the impact force to a distal end of the shaft

4. The device of claim 1, where the energy transfer unit comprises an extendable element and a portion of the shaft, where the extendable element is configured to extend axially relative to a distal end of the shaft.

5. The device of claim 1, where at least one of the temperature detecting elements is axially moveable along the shaft independently of the energy transfer unit.

6. The device of claim 1, further comprising an introducer cannula having a length, where the shaft further includes a first and a second visual markers on a proximal end of the shaft adjacent to the handle, where each marker corresponds to the first or second temperature detecting element, such that when placed within the introducer cannula, the markers allow determination of whether the first or second temperature detecting element is distally adjacent to an end of the introducer cannula.

9. The method of claim 2, where controlling expansion of the region of heated tissue comprises ceasing application of the energy when the actual temperature reaches the at least one associated temperature.

7. A method of applying energy to tissue, the method comprising:

positioning a treatment device into a tissue area, the treatment device having an energy transfer portion located at a distal portion of a shaft, the treatment device further including at least a first temperature detecting element coupled to the shaft and axially along the shaft from the energy transfer portion;

applying energy to the energy transfer portion to produce a region of heated tissue about the energy transfer portion;

continuing application of the energy to expand the region of heated tissue;

measuring an actual temperature of a tissue area adjacent to the at least the first temperature detecting element; and

comparing the actual temperature to at least one associated temperature to estimate a size of the region of heated tissue where the associated temperature correlates to a previously measured region of heated tissue having a known size.

8. The method of claim 7, controlling expansion of the region of heated tissue after comparing the actual temperature to the at least one associated temperature.

10. The method of claim 7, where positioning the treatment device into the tissue area comprises positioning the treatment device in an area selected from the group consisting of a vertebral body, a tumor, and surrounding tissue.

11. The method of claim 7, where monitoring the size of the region of heated tissue further comprises determining a characteristic selected from a volume of the region of heated tissue and a length of the region of heated tissue.

12. The method of claim 7, where monitoring the size of the region of heated tissue further comprises providing, user feedback selected from the group consisting of:

the actual temperature is approaching the at least one associated temperature and an approximated length of the region of heated tissue.

13. The method of claim 7, monitoring the size of the region of heated tissue comprises adjusting a power supplied to the energy transfer portion during, the continuing application of energy to control growth of the region of heated tissue.

14. The method of claim 7, wherein an axial distance between the at least the first temperature detecting element and the energy transfer portion can be adjusted between a plurality of positions, the method further comprising selecting one of the plurality of positions to adjust the axial distance between the at least the first temperature detecting element and the energy transfer portion.

15. The method of claim 7, where the previously measured region of heated tissue is one of a plurality of previously measured regions of heated tissue and where the at least one associated temperature comprises a plurality of associated temperatures each corresponding to the plurality of previously measured regions of heated tissue, where each of the plurality of previously measured regions of heated tissue comprises a distinct shape.

16. The method of claim 15, further comprising controlling expansion of the region of heated tissue after comparing the actual temperature to at least one of the plurality of associated temperature by selecting one of the plurality of associated temperatures and ceasing application of the energy when the actual temperature reaches the selected one of the plurality of associated temperature.

17. The method of claim 7, where the at least the first temperature detecting element comprises a plurality of temperature detecting elements spaced along the shaft of the treatment device.

18. The method of claim 7, where the at least the first temperature detecting element is proximally spaced from a distal end of the energy transfer portion.

19. The method of claim 7, where the energy transfer portion comprises an energy modality selected from the group consisting of mono-polar radiofrequency (RF) energy, bi-polar radiofrequency (RF) energy, resistive heating, radiant heating, coherent light, microwave, laser, chemical or any other heat generating methods.

20. The method of claim 7, where the energy transfer portion comprises a first energy transfer portion, and further comprises a second energy transfer portion adjacent to the first energy transfer portion.

21. The method of claim 7, where positioning the treatment device comprises positioning the at least the first temperature detecting element adjacent to a target site within the tissue.

23. The medical system of claim 17, where the shaft includes an articulating portion.

24. The medical system of claim 17, the shaft and the handle are configured to receive an impact force applied on the handle and transfer the impact force to a distal end of the shaft.

25. The medical system of claim 17, where the energy transfer unit comprises an extendable element and a portion of the shaft, where the extendable element is configured to extend axially relative to a distal end of the shaft.

26. The medical system of claim 17, where at least one of the temperature detecting elements is axially moveable along the shaft independently of the energy transfer unit.

27. The medical system of claim 17, further comprising an introducer cannula having a length, where the shaft further includes a first and a second visual markers on a proximal end of the shaft adjacent to the handle, where each marker corresponds to the first or second temperature detecting element, such that when placed within the introducer cannula, the markers allow determination of whether the first or second temperature detecting element is distally adjacent to an end of the introducer cannula.

22. A medical system for creating regions of heated tissue using temperature to monitor a desired profile of the regions, the medical system comprising:

an energy controller capable of controlling energy delivery in response to comparing at least one temperature measurements to at least at least one associated temperature, where the associated temperature correlates to a previously measured region of heated tissue having a known profile;

a treatment device having a shaft coupled to a handle, where the handle includes a connector for electrically coupling to the energy control unit; and

a shaft extending from the handle to a distal portion, an energy transfer portion for delivering energy from the power supply to tissue located at the distal portion; and

at least a first and second temperature detecting elements spaced proximally from a proximal end of the energy transfer portion, each temperature sensor configured to independently and respectively provide a first and a second actual temperature measurements to the energy controller.