Image-guided therapy of a tissue

• US 9,492,121 B2
• Filed: 03/18/2015
• Issued: 11/15/2016
• 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): TANNER, JOCELIN C
• Application Number:
  US14/661,212
• Publication Number:
  US 20150265290A1
• Time in Patent Office: 608 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
• 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 neurosurgical instrument introduction apparatus comprising:

a low profile skull anchor device configured to attach to an area of a skull of a patient, the low profile skull anchor device including an upper surface and a lower surface, wherein

the low profile skull anchor device comprises a central opening at least sixty millimeters in diameter for providing access to an entry formed in the skull of the patient,

the low profile skull anchor device includes at least two different types of fasteners for connecting to the skull of the patient, and

the lower surface of the low profile skull anchor device forms a gap between a surface of the skull of the patient upon mounting the low profile skull anchor device to the skull of the patient, wherein

the gap provides clearance for a scalp region of the patient without skin compression, and

the gap is 30 millimeters or less from the surface of the skull of the patient; and

a removable guide stem configured to detachably connect to the low profile skull anchor device, wherein

the removable guide stem comprises an opening that, when connected to the low profile skull anchor device, is positioned above the entry formed in the skull of the patient, and

the removable guide stem is configured to adjust a trajectory corresponding to the opening of the removable guide stem in at least one of a pivot alignment and a rotation alignment.

2. The apparatus of claim 1, wherein the at least two types of fasteners include bone screws for attaching to bone anchors set in the skull of the patient and pins for further attaching the low profile skull anchor device to the skull of the patient.

3. The apparatus of claim 2, wherein the at least two types of fasteners include at least three bone screws and at least three pins for attaching the low profile skull anchor device to the skull of the patient.

4. The apparatus of claim 1, wherein the removable guide stem comprises a ball joint that adjusts the trajectory corresponding to the opening of the removable guide stem.

5. The apparatus of claim 1, wherein the removable guide stem comprises a tilt adjustment mechanism that adjusts the pivot alignment corresponding to the opening of the removable guide stem and a rotation adjustment mechanism that adjusts the rotational alignment corresponding to the opening of the removable guide stem.

6. The apparatus of claim 1, wherein at least one of the removable guide stem and the low profile skull anchor device includes a plurality of guide markers that enables selection of a particular trajectory of a plurality of trajectories associated with the opening of the removable guide stem.

7. The apparatus of claim 1, further comprising a plurality of fiducial markers detectable by a magnetic resonance imaging (MRI) system, wherein the plurality of fiducial markers are arranged on at least one of the removable guide stem and the low profile skull anchoring device.

8. The apparatus of claim 1, wherein the removable guide stem is configured to linearly adjust the opening of the removable guide stem relative to the low profile skull anchor device in an x, y plane defined by the central opening of the low profile skull anchor device, such that the opening of the removable guide stem can be offset relative to the center opening of the low profile skull anchor device.

9. The apparatus of claim 8, wherein the opening of the removable guide stem is linearly adjustable in the x,y plane by at least ten millimeters.

10. The apparatus of claim 1, wherein the removable guide stem is configured to linearly adjust the opening of the removable guide stem relative to the low profile skull anchor device in an x, y plane orthogonal to a linear axis of the trajectory of the opening of the removable guide stem.

11. The apparatus of claim 1, further comprising a guide sheath for intracranial insertion proximate to a tissue region of interest, wherein the removable guide stem includes a lock mechanism configured to lock the guide sheath to the removable guide stem at a selected linear depth of insertion with respect to the opening of the removable guide stem, the selected linear depth of insertion being selected from a plurality of linear depths of insertion.

12. The apparatus of claim 1, wherein the opening of the removable guide stem is cylindrical in shape.

13. An apparatus for neurosurgical instrument introduction, comprising:

a low profile skull anchor device configured to attach to an area of a skull of a patient, the low profile skull anchor device including an upper surface and a lower surface, wherein

the low profile skull anchor device comprises a central opening at least sixty millimeters in diameter for providing access to an entry formed in the skull of the patient, and

the low profile skull anchor device includes at least three bone screws and at least three pins for connecting to the skull of the patient; and

a removable guide stem configured to detachably connect to the low profile skull anchor device, wherein

the removable guide stem comprises an opening that, when connected to the low profile skull anchor device, is positioned above the entry formed in the skull of the patient, and

at least one of the low profile skull anchor device and the removable guide stem comprises at least one of

a tilt adjustment mechanism for use in adjusting a pivot alignment corresponding to the opening of the removable guide stem, and

a rotation adjustment mechanism for use in adjusting a rotational alignment corresponding to the opening of the removable guide stem;

wherein the low profile skull anchor device and the removable guide stem consist of materials that are compatible with and can operate within an operational field of a medical imaging system to image the tissue without substantially disrupting imaging performed by the medical imaging system.

14. The apparatus of claim 13, wherein the low profile skull anchor device comprises at least three fiducial markers arranged upon a surface region.

15. The apparatus of claim 14, wherein a first fiducial marker of the at least three fiducial markers differs from the remaining fiducial marker of the at least three fiducial markers in one or more of length, width, and shape.

16. The apparatus of claim 13, wherein a trajectory corresponding to the opening of the guide stem is adjusted by actuating, by a processor executing instructions stored upon a non-transitory computer readable medium, a guidance device to adjust a position of at least one of the tilt adjustment mechanism and the rotation adjustment mechanism.

17. The apparatus of claim 13, wherein the medical imaging system comprises an MRI system.

18. The apparatus of claim 13, wherein:

the lower surface of the low profile skull anchor device forms a gap between a surface of the skull of the patient upon mounting the low profile skull anchor device to the skull of the patient, wherein

the gap provides clearance for a scalp region of the patient without skin compression, and

the gap is 30 millimeters or less from the surface of the skull of the patient.

19. An apparatus for neurosurgical instrument introduction, comprising:

a low profile skull anchor device comprising at least two types of fasteners for attaching to an area of a skull of a patient, the low profile skull anchor device including an upper surface and a lower surface, wherein

the low profile skull anchor device comprises a central opening at least sixty millimeters in diameter for providing access to an entry formed in the skull of the patient, and

the lower surface of the low profile skull anchor device, when mounted to the skull of the patient using the at least two types of fasteners, provides a mounting height of the low profile skull anchor device of 30 millimeters or less from a surface of the skull of the patient to a lower surface of the low profile skull anchor device, wherein the mounting height is configured to provide a clearance for a scalp region of the patient without skin compression; and

a removable guide stem configured to detachably connect to the low profile skull anchor device, the removable guide stem comprising an opening for access, upon connection to the skull of the patent, to at least a portion of the entry;

wherein at least one of the low profile skull anchor device and the removable guide stem is configured to

adjust a trajectory corresponding to the opening of the removable guide stem in at least one of a pivot alignment and a rotation alignment, and

lock at least one of the pivot alignment and the rotation alignment at a current trajectory.

20. The apparatus of claim 19, further comprising a guide sheath for intracranial insertion proximate to a tissue region of interest for introducing a neurosurgical instrument into the skull of the patient via the entry, wherein

the guide sheath comprises a proximal opening and a distal opening, and

the guide sheath is configured for insertion in the removable guide stem, wherein at least one of the removable guide stem and the guide sheath comprises a locking mechanism for locking a linear depth of the guide sheath within the skull of the patient.

21. The apparatus of claim 20, wherein the guide sheath comprises a plurality of connection points for mating with the locking mechanism of the guide stem.

22. The apparatus of claim 21, wherein each consecutive pair of connection points of the plurality of connection points is separated by a precise distance to enable selection of a particular depth of a plurality of depths.

23. The apparatus of claim 20, further comprising a second guide sheath for introduction of another neurosurgical instrument, wherein a diameter of a distal opening of the second guide sheath is smaller than the diameter of the distal opening of the guide sheath.

24. The apparatus of claim 23, wherein the second guide sheath is configured for insertion within the guide sheath.

25. The apparatus of claim 19, further comprising a second removable guide stem having a smaller diameter opening than the removable guide stem, wherein the removable guide stem and the second removable guide stem are configured to be interchangeably connected to the low profile skull anchor device.

26. The apparatus of claim 25, wherein a shape of the opening of the second removable guide stem is different from a shape of an opening of the removable guide stem.

27. The apparatus of claim 19, wherein the at least two types of fasteners include bone screws for attaching to bone anchors set in the skull of the patient and pins for further attaching the low profile skull anchors device to the skull of the patient.