Methods and systems for use in controlling tissue ablation volume by temperature monitoring

• US 8,864,760 B2
• Filed: 03/11/2013
• Issued: 10/21/2014
• 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
• Primary Examiner(s): DELLA, JAYMI E
• Application Number:
  US13/793,632
• Publication Number:
  US 20130261615A1
• Time in Patent Office: 589 Days
• Field of Search: 606/34, 606/38, 606/41
• US Class Current: 606/41
• 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 a region of heated tissue using temperature to monitor a desired profile of the region, the medical device, comprising:

a shaft coupled to a handle, where the handle includes a connector for electrically coupling to a source of energy;

a first temperature detecting element spaced axially and proximally along the shaft from a proximal end of an energy transfer portion located at a working end of the shaft;

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 measurement; and

an energy controller capable of delivering energy from the source of energy to the energy transfer portion, the energy controller configured to control the delivering of the energy in response to comparing at least the first or second actual temperature measurements to at least one associated temperature, where the associated temperature correlates to a previously measured region of heated tissue having a known profile.

2. The medical 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 medical 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 medical 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 medical device of claim 1, where at least one of the first and second temperature detecting elements is axially moveable along the shaft independently of the energy transfer portion.

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

7. The medical device of claim 1, where the shaft further comprises a first sleeve located concentrically within a second sleeve, the shaft having a distal portion comprising the working end capable of moving reversibly between a linear configuration and an articulated configuration in response to movement of an actuating portion coupled to the handle, where the articulated configuration is limited to a single plane, and where the first and second sleeves comprise a series of slots or notches to limit deflection of the working end to the articulated configuration, where the series of slots or notches are radially offset between the first sleeve and second sleeve;

and

where the actuating portion includes a ratchet mechanism to permit temporary locking of the working end in a certain degree of rotation.

8. The medical device of claim 7, further comprising a force-limiting assembly coupled between the actuating portion and the first sleeve such that upon reaching a threshold force, the actuating portion disengages the first sleeve.

9. The medical device of claim 7 further comprising, a sharp tip located at a distal tip of the working end of the shaft, the sharp tip adapted to penetrate hard tissue and a point of the sharp tip is offset to engage hard tissue when advanced therein to assist in deflecting the working end.

10. The medical device of claim 7, wherein the first sleeve is coupled to the actuating portion coupled to the handle such that rotation of the actuating portion coupled to the handle is configured to cause axial movement of the first sleeve to deform the working end into the articulated configuration.