# US 9,492,121 B2 · Image-guided therapy of a tissue

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- Number: US 9,492,121 B2
- Document ID: US9492121B2
- Status: Granted
- Kind: B2
- Application number: 14/661,212
- Filed: 2015-03-18
- Published: 2015-09-24
- Granted: 2016-11-15
- Earliest claimed: 2014-03-18
- Assignees: Monteris Medical Corporation
- Applicants: Monteris Medical Corporation
- Inventors: Eric Andrews; Mark Grant; Brooke Ren; Richard Tyc
- Web page: https://patentgrep.com/patent/US9492121B2

## CPC

- A61B 90/14: Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
- A61B 5/0042: {for the brain}
- A61B 5/015: {By temperature mapping of body part}
- A61B 5/055: involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
- A61B 5/4839: {combined with drug delivery}
- A61B 5/702: {Posture restraints}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 5/748: {Selection of a region of interest, e.g. using a graphics tablet}
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 6/04: Positioning of patients; Tiltable beds or the like
- A61B 6/0421: {with immobilising means}
- A61B 6/0492: {using markers or indicia for aiding patient positioning}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/1703: {using imaging means, e.g. by X-rays}
- A61B 17/1739: {specially adapted for particular parts of the body}
- A61B 17/3403: {Needle locating or guiding means}
- A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18)
- A61B 18/1477: {Needle-like probes}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/22: the beam being directed along or through a flexible conduit, e.g. an optical fibre; {Couplings or} hand-pieces therefor
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 90/11: with guides for needles or instruments, e.g. arcuate slides or ball joints
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 90/50: Supports for surgical instruments, e.g. articulated arms
- A61F 5/37: Restraining devices for the body or for body parts; Restraining shirts
- A61F 5/3707: {for the head (cervical supports A61F5/055; splints A61F5/05883)}
- A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent}
- A61N 7/02: Localised ultrasound hyperthermia
- A61N 7/022: {intracavitary}
- A61B 5/0035: {adapted for acquisition of images from more than one imaging mode, e.g. combining MRI and optical tomography}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 2018/00011: {with fluids}
- A61B 2018/00321: {Head or parts thereof}
- A61B 2018/00446: {Brain}
- A61B 2018/00791: {Temperature}
- A61B 2018/0293: {using an instrument interstitially inserted into the body, e.g. needle}
- A61B 2018/1869: {with an instrument interstitially inserted into the body, e.g. needles}
- A61B 2018/20361: {with redirecting based on sensed condition, e.g. tissue analysis or tissue movement}
- A61B 2034/107: {Visualisation of planned trajectories or target regions}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2065: {Tracking using image or pattern recognition}
- A61B 2090/103: {Cranial plugs for access to brain}
- A61B 2090/374: {NMR or MRI}
- A61B 2090/3954: {magnetic, e.g. NMR or MRI}
- A61B 2576/026: for the brain
- A61N 5/1048: {Monitoring, verifying, controlling systems and methods}
- A61N 2005/1051: {using an active marker}
- A61N 2005/1055: {using magnetic resonance imaging [MRI]}
- A61N 2005/1097: {Means for immobilizing the patient}
- A61N 2007/003: {Destruction of nerve tissue}
- A61N 2007/0047: {interstitial}
- A61N 2007/025: {interstitial}
- G16H 30/40: for processing medical images, e.g. editing
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 8)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 1)

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

### Claim 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.

### Claim 14 (depends on 13)

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

### Claim 15 (depends on 14)

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.

### Claim 16 (depends on 13)

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.

### Claim 17 (depends on 13)

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

### Claim 18 (depends on 13)

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.

### Claim 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.

### Claim 20 (depends on 19)

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.

### Claim 21 (depends on 20)

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.

### Claim 22 (depends on 21)

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.

### Claim 23 (depends on 20)

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.

### Claim 24 (depends on 23)

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

### Claim 25 (depends on 19)

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.

### Claim 26 (depends on 25)

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.

### Claim 27 (depends on 19)

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.
