Image-guided therapy of a tissue

• US 9,486,170 B2
• Filed: 03/18/2015
• Issued: 11/08/2016
• Est. Priority Date: 03/18/2014
• Status: Active Grant

• Current Assignee: Monteris Medical Incorporated (Monteris Medical US, Inc.)
• Original Assignee: Monteris Medical Incorporated (Monteris Medical US, Inc.)
• Inventors: Andrews, Eric, Grant, Mark, Ren, Brooke, Tyc, Richard
• Primary Examiner(s): Lamprecht, Joel
• Application Number:
  US14/661,170
• Publication Number:
  US 20150265365A1
• Time in Patent Office: 601 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• 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 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00321 Head or parts thereof
• CPC Class Codes: A61B 2018/00446 Brain
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/0293 using an instrument interstitially inserted into the body, e.g. needle
• CPC Class Codes: A61B 2018/1869 with an instrument interstitially inserted into the body, e.g. needles
• CPC Class Codes: A61B 2018/20361 with redirecting based on sensed condition, e.g. tissue analysis or tissue movement
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/3954 : magnetic, e.g. NMR or MRI
• CPC Class Codes: A61B 2576/026 : for the brain
• CPC Class Codes: A61B 34/10 : Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/0035 : adapted for acquisition of images from more than one imaging mode, e.g. combining MRI and optical tomography
• CPC Class Codes: A61B 5/0042 : for the brain
• CPC Class Codes: A61B 5/01 : Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/015 : By temperature mapping of body part
• CPC Class Codes: A61B 5/055 : involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/702 : Posture restraints
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/748 : Selection of a region of interest, e.g. using a graphics tablet
• CPC Class Codes: A61B 6/032 : Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/04 : Positioning of patients; Tiltable beds or the like operating tables A61G13/00; operating chairs A61G15/00
• CPC Class Codes: A61B 6/0421 : with immobilising means
• CPC Class Codes: A61B 6/0492 : using markers or indicia for aiding patient positioning
• CPC Class Codes: A61B 90/11 : with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61B 90/14 : Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/50 : Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 5/37 : Restraining devices for the body or for body parts , e.g. slings; Restraining shirts handcuffs E05B75/00
• CPC Class Codes: A61F 5/3707 : for the head cervical supports A61F5/055; splints A61F5/05883
• CPC Class Codes: A61N 2005/1051 : using an active marker markers in general A61B90/39
• CPC Class Codes: A61N 2005/1055 : using magnetic resonance imaging [MRI]
• CPC Class Codes: A61N 2005/1097 : Means for immobilizing the patient
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 2007/0047 : interstitial
• CPC Class Codes: A61N 2007/025 : interstitial
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/1048 : Monitoring, verifying, controlling systems and methods
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: A61N 7/022 : intracavitary
• CPC Class Codes: G16H 30/40 : for processing medical images, e.g. editing

Abstract

Image-guided therapy of a tissue can utilize magnetic resonance imaging (MRI) or another medical imaging device to guide an instrument within the tissue. A workstation can actuate movement of the instrument, and can actuate energy emission and/or cooling of the instrument to effect treatment to the tissue. The workstation and/or an user of the workstation can be located outside a vicinity of an MRI device or other medical imaging device, and drive means for positioning the instrument can be located within the vicinity of the MRI device or the other medical imaging device. The instrument can be an MRI compatible laser or high-intensity focused ultrasound probe that provides thermal therapy to, e.g., a tissue in a brain of a patient.

Claims

1. A method for effecting thermal therapy using an in vivo probe, comprising:

identifying a three-dimensional region of interest at which to apply thermal therapy;

positioning the probe in a volume in the patient through a removable guide stem, wherein the volume is adjacent to or included in the three-dimensional region of interest;

identifying, by processing circuitry, a treatment profile for effecting thermal therapy to the three-dimensional region of interest, wherein the treatment profile comprises i) a plurality of target positions, and ii) for each target position of the plurality of target positions, one or more of a respective power level, a respective energy level, a respective emission pattern, a respective time period, and a respective geometry of a target area of the three-dimensional region of interest;

deploying, through a first distal opening of at least one distal opening of the guide stem, the probe to the three-dimensional region of interest at a first radial trajectory corresponding to a first target position of the plurality of target positions according to the treatment profile; and

applying, by the processing circuitry, thermal therapy to the volume using the probe according to the treatment profile, wherein applying the thermal therapy comprises

a) activating delivery of therapeutic energy by the probe to the three-dimensional region of interest at the first target position,

b) after delivery of therapeutic energy, retracting the probe into the guide sheath;

c) causing actuation of the probe, in the guide sheath, to adjust at least one of a linear position and a rotational position of the probe to select a next radial position,

d) deploying the probe, through a next distal opening of the guide stem, to the three-dimensional region of interest at the next radial trajectory corresponding to a next target position of the plurality of target positions according to the treatment profile,

e) activating delivery of therapeutic energy to the three-dimensional region of interest at the next target position according to the treatment profile, and

repeating steps (b) through (e) until therapeutic energy is delivered to at least a first volume of the three-dimensional region of interest.

2. The method of claim 1, wherein the next distal opening is the first distal opening, and the probe is a pre-shaped probe.

3. The method of claim 1, wherein applying thermal therapy further comprises:

while delivering therapeutic energy at the first target position, monitoring a temperature of a point, wherein the point is one of within the three-dimensional region of interest and adjacent to the three-dimensional region of interest; and

prior to adjusting the probe to the next target position, determining, based at least in part upon at least one of i) the temperature of the point and ii) a thermal dose that is based on a temperature history of the three-dimensional region of interest over a specified time period, to conclude delivery of therapeutic energy at the first target position, the thermal dose including a thermal dose of the point.

4. The method of claim 3, wherein monitoring the temperature of the point comprises performing thermographic analysis of magnetic resonance (MR) images.

5. The method of claim 4, wherein applying thermal therapy further comprises monitoring a temperature of an external point that is external to the three-dimensional region of interest, wherein

the thermal dose is calculated based on a temperature history over the specified time period of the respective external point, and

the external point is one of i) at a periphery of the region of interest and ii) between the periphery of the region of interest and an emission region of the probe.

6. The method of claim 5, wherein applying thermal therapy further comprises, responsive to monitoring the temperature of the external point, adjusting delivery of therapeutic energy to minimize damage to tissue near the probe.

7. The method of claim 5, wherein applying thermal therapy further comprises, responsive to monitoring the temperature of the external point, activating a cooling functionality of the probe to minimize damage to tissue near the probe.

8. The method of claim 3, wherein monitoring the temperature of the point comprises indicating, based at least in part upon the thermal dose of the point, thermal damage of tissue at the first target position.

9. A system for effecting in vivo thermal therapy comprising:

a thermal imaging system;

a removable guide stem for deployment within a skull of a patient;

a probe configured for deployment through the removable guide stem;

a probe driver configured to actuate the probe in at least a linear direction;

a processor; and

a memory having instructions stored thereon, wherein the instructions, when executed by the processor, cause the processor to;

identify a treatment profile for effecting thermal therapy to a three-dimensional region of interest,

direct a probe driver to deploy, through a first distal opening of at least one distal opening of the guide stem while the guide stem is positioned within in a volume in the patient, the probe to the three-dimensional region of interest at a first radial trajectory corresponding to a first target position of the plurality of target positions according to the treatment profile, and

apply thermal therapy to the volume using the probe according to the treatment profile, wherein applying thermal therapy comprises

a) activating delivery of therapeutic energy by the probe to the three-dimensional region of interest at the first target position,

b) monitoring a respective temperature of each point of at least one point at the first target position, wherein

each point of the at least one point at the first target position is one of within the three-dimensional region of interest and adjacent to the three-dimensional region of interest, and

monitoring comprises receiving a plurality of imaging data sets from the thermal imaging system, and determining one or more temperature values from the imaging data, wherein each imaging data set of the plurality of imaging data sets represents data captured at a different time over a period of time by the thermal imaging system,

c) determining, based at least in part upon at least one of the respective temperature and a respective thermal dose of each of the at least one point at the first target position, completion of thermal therapy at the first target position, the respective thermal dose being based on a temperature history of each of the at least one point at the first target position over a specified time period,

d) directing the probe driver to retract the probe into the guide stem,

e) directing the probe driver to adjust at least one of a linear position and a rotational position of the probe, in the guide sheath, to select a next radial trajectory,

f) directing the probe driver to deploy the probe, through a next distal opening of the guide stem, to the three-dimensional region of interest at the next radial trajectory corresponding to a next target position of the plurality of target positions according to the treatment profile,

g) activating delivery of therapeutic energy by the probe to the three-dimensional region of interest at the next target position,

h) monitoring at least one of the respective temperature and the respective thermal dose of each point of the at least one point at the next target position, wherein each point of the at least one point at the next target position is one of within the three-dimensional region of interest and adjacent to the three-dimensional region of interest,

i) determining, based at least in part upon at least one of i) the respective temperature of each point of the at least one point at the next target position, and ii) the respective thermal dose of each point of the at least one point at the next target position, completion of treatment at the next target position, and

j) repeating steps (d) through (i) until therapeutic energy is delivered to at least a first volume of the three-dimensional region of interest.

10. The system of claim 9, further comprising a workstation located in a control room separate from a room containing the probe and probe driver, wherein the workstation comprises the processor.

11. The system of claim 10, wherein:

thermal therapy is initiated by user input received via the workstation; and

delivery of therapeutic energy is activated responsive to receipt of an activation input via an input device in communication with the workstation, wherein the input device is operable to be manipulated by a user.

12. The system of claim 9, wherein the probe is a flexible laser probe.

13. The system of claim 10, wherein the instructions, when executed, further cause the processor to:

direct the probe driver to retract the probe from the volume;

direct the probe driver to position a second instrument within the volume; and

apply a second therapy to another three-dimensional region of interest using the second instrument.

14. The system of claim 13, wherein:

the thermal therapy causes reversible thermal damage; and

the second instrument is a pharmaceutical agent delivery instrument.

15. The system of claim 13, wherein the probe and the second instrument are simultaneously positioned within the guide sheath.

16. The system of claim 15, wherein the guide sheath is a multi-lumen guide sheath, wherein the probe is positioned in a first lumen of the guide sheath and the second instrument is positioned in a second lumen of the guide sheath.

17. The system of claim 13, wherein the instructions, when executed, cause the processor to, prior to applying the second therapy, verify a current placement of the second instrument.

18. The system of claim 17, wherein verifying a current placement of the second instrument comprises identifying evidence of one or more fiducial markers within imaging data of the volume.

19. The system of claim 18, wherein verifying the current placement of the second instrument comprises:

identifying, within imaging data, a plurality of fiducial markers; and

calculating an instrument position based at least in part upon identification of the plurality of fiducial markers.

20. A non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a processor, cause the processor to effect thermal therapy to a three-dimensional region of interest within a patient using a pre-shaped probe, effecting thermal therapy comprising:

a) identifying a first emission level for treatment of the three-dimensional region of interest at a first radial trajectory of the pre-shaped probe,

b) deploying the pre-shaped probe from a guide sheath, at the first radial trajectory to treat a first position of the three-dimensional region of interest,

c) activating delivery of therapeutic energy by the pre-shaped probe at the first emission level to the three-dimensional region of interest at the first position;

d) receiving, from at least one of a magnetic resonance (MR) imaging system and a thermometry imaging system, feedback data related to a first target area, wherein the feedback data comprises at least one of temperature data and imaging data;

e) determining, based at least in part on the feedback data, completion of thermal therapy at the first position;

f) retracting the pre-shaped probe into the guide sheath;

g) actuating the pre-shaped probe, within the guide sheath, in at least one of a linear direction and a rotational direction to select a next radial trajectory;

h) deploying the pre-shaped probe outside the guide sheath at the next radial trajectory to treat a next position;

i) identifying a next emission level for treatment of the three-dimensional region of interest at the next position of the pre-shaped probe;

j) activating delivery of therapeutic energy by the pre-shaped probe at the next emission level to the three-dimensional region of interest at the next position;

k) monitoring feedback data related to the next target area;

l) determining, based at least in part on the feedback data, completion of thermal therapy at the next position; and

m) repeating steps (f) through (l) until therapeutic energy is delivered to at least a first volume of the three-dimensional region of interest.

21. The computer readable medium of claim 20, wherein deploying the pre-shaped probe from the guide sheath, at the first radial trajectory comprises selecting a first delivery hole of the guide sheath and deploying the pre-shaped probe from the guide sheath at the next radial trajectory comprises selecting a next delivery hole of the guide sheath different than the first delivery hole of the guide sheath.

22. The computer readable medium of claim 21, wherein the probe projects from the first delivery hole at a first angle of projection different than a second angle of projection out of the next delivery hole.

23. The computer readable medium of claim 21, wherein the instructions, when executed, cause the processor to, after delivery of thermal therapy to the first volume of the three-dimensional region of interest:

activate retraction of the probe into the guide sheath;

activate positioning of a second therapeutic instrument within the volume, wherein the second therapeutic instrument is deployed from the guide sheath; and

apply a second therapy to the three-dimensional region of interest using the second therapeutic instrument.

24. The computer readable medium of claim 23, wherein the second therapeutic instrument is one of a needle, a fiber, and an intravenous line.

25. The computer readable medium of claim 20, wherein a tip region of the pre-shaped probe comprises at least one fiducial marker for confirming, via MRI imaging, a current trajectory of the pre-shaped probe upon deployment from the guide sheath.