# US 11,298,204 B2 · Trajectory guide with dual gimbal drive arrangement

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- Number: US 11,298,204 B2
- Document ID: US11298204B2
- Status: Granted
- Kind: B2
- Application number: 16/265,704
- Filed: 2019-02-01
- Published: 2020-08-06
- Granted: 2022-04-12
- Earliest claimed: 2019-02-01
- Assignees: Advanced Neuromodulation Systems, Inc.
- Applicants: Advanced Neuromodulation Systems, Inc.
- Inventors: Robert E. Jones; Galen L. Smith
- Web page: https://patentgrep.com/patent/US11298204B2

## CPC

- A61B 90/11: with guides for needles or instruments, e.g. arcuate slides or ball joints
- A61B 1/0016: {using motor drive units}
- A61B 90/50: Supports for surgical instruments, e.g. articulated arms
- A61B 1/313: for introducing through surgical openings, e.g. laparoscopes
- A61B 1/3135: {for examination of the epidural or the spinal space}
- A61B 10/04: Endoscopic instruments, e.g. catheter-type instruments
- A61B 2017/00911: {for fields applied by a magnetic resonance imaging system}
- A61B 2017/3407: {including a base for support on the body}
- A61B 2017/3409: {including needle or instrument drives}
- A61B 2018/00446: {Brain}
- A61B 2018/00577: {Ablation}
- A61B 2090/103: {Cranial plugs for access to brain}
- A61B 2217/005: with suction drainage system
- A61B 2217/007: with irrigation system
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61N 1/0534: {Electrodes for deep brain stimulation}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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)

## Abstract

A trajectory guiding apparatus and one or more methods associated therewith for facilitating precision-guided alignment and implantation of a DBS therapy device in a patient. A pivotally rotatable stage is pivotally coupled to a base support and a vertical support operative to support a slider assembly arranged to accommodate an instrumentation column (IC) containing the therapy device. A first gimbal drive is disposed between the pivotally rotatable stage and the base support, wherein the first gimbal drive is actuatable to cause a first pivotal motion of the slider assembly including the IC, the first pivotal motion defined along a first arcuate path pivoted around a first pivotal axis. A second gimbal drive is disposed between the pivotally rotatable stage and the vertical support, wherein the second gimbal drive is actuatable to cause a second pivotal motion of the slider assembly including the IC, the second pivotal motion defined along a second arcuate path pivoted around a second pivotal axis perpendicular to the first pivotal axis.

## Claims

### Claim 1

A trajectory guiding apparatus, comprising:
a base support comprising a frame portion and a first pivot housing portion, the frame portion having a first aperture sized to surround a burr hole opening in a patient's cranium and the frame portion configured for fastening the base support to the patient's cranium, wherein the base support further includes a first gimbal coupler;
a pivotally rotatable stage pivotally coupled to the base support at the first pivot housing portion defining a first pivotal axis, wherein the pivotally rotatable stage includes a stage portion and a second pivot housing portion, the stage portion having a second gimbal coupler and a third gimbal coupler;
a vertical support having a bottom end and a top end, the bottom end pivotally coupled to the pivotally rotatable stage at the second pivot housing portion defining a second pivotal axis, wherein the first and second pivotal axes are perpendicular to each other, the bottom end including a fourth gimbal coupler; and
a slider assembly removably coupled to the vertical support at the top end, the slider assembly including a second aperture at least as large as the first aperture in the frame portion and configured to accommodate an instrumentation column having a columnar passage therethrough and coupled to a drive assembly for advancing a distal end of an elongate medical device through the columnar passage of the instrumentation column,
wherein a first gimbal drive is coupled between the first gimbal coupler of the base support and the second gimbal coupler of the stage portion of the pivotally rotatable stage, the first gimbal drive actuatable to cause a first pivotal motion of the slider assembly including the instrumentation column, the first pivotal motion defined along a first arcuate path pivoted around the first pivotal axis,
wherein a second gimbal drive is coupled between the third gimbal coupler of the stage portion of the pivotally rotatable stage and the fourth gimbal coupler of the bottom end of the vertical support, the second gimbal drive actuatable to cause a second pivotal motion of the slider assembly including the instrumentation column, the second pivotal motion defined along a second arcuate path pivoted around the second pivotal axis, the first and second arcuate paths being perpendicular to each other, and
wherein the first and second gimbal drives are independently actuatable such that after aligning a distal end of the instrumentation column with a target entry point in the burr hole using the slider assembly, an axial angle of the instrumentation column is operative to be adjusted by actuating at least one of the first and second gimbal drives while maintaining the alignment of the distal end of the instrumentation column with the target entry point in the burr hole.

### Claim 2 (depends on 1)

The trajectory guiding apparatus as recited in claim 1, wherein the slider assembly further comprises:
a coupling portion having a coupling mechanism configured for facilitating removable coupling with the top end of the vertical support, the coupling portion laterally extending to form a platform portion having a grooved surface surrounding the second aperture therein;
a lower plate slidably engaged with the grooved surface of the platform portion, the lower plate having a third aperture at most as large as the second aperture; and
an upper plate slidably engaged with the lower plate and configured to rigidly couple to the instrumentation column,
wherein the lower plate is operative to slide along a first axis and the upper plate is operative to slide along a second axis, the first and second axes orthogonal to each other and disposed along a translational motion plane substantially parallel relative to a burr hole plane that is co-planar with the burr hole.

### Claim 3 (depends on 2)

The trajectory guiding apparatus as recited in claim 2, wherein the frame portion of the base support comprises an annular structure having a circular orifice forming the first aperture, the circular orifice sized to surround the burr hole in a close proximity.

### Claim 4 (depends on 3)

The trajectory guiding apparatus as recited in claim 3, wherein the first and second gimbal drives each comprise a respective angled screw drive having a threaded shaft.

### Claim 5 (depends on 4)

The trajectory guiding apparatus as recited in claim 4, wherein an angular range of the first pivotal motion is determined by at least one of an angle of the threaded shaft of the first gimbal drive relative to the burr hole plane and a length of the threaded shaft of the first gimbal drive.

### Claim 6 (depends on 5)

The trajectory guiding apparatus as recited in claim 5, wherein an angular range of the second pivotal motion is determined by at least one of an angle of the threaded shaft of the second gimbal drive relative to the burr hole plane and a length of the threaded shaft of the second gimbal drive.

### Claim 7 (depends on 6)

The trajectory guiding apparatus as recited in claim 6, wherein the frame portion includes a minimum number of holes for securely fastening the base support to the patient's cranium with screws of biocompatible and magnetic resonance imaging (MRI) compatible material.

### Claim 8 (depends on 7)

The trajectory guiding apparatus as recited in claim 7, wherein the first and second gimbal drives are configured such that the angular ranges of the first and second pivotal motions are optimized to allow a maximum access to the burr hole during a neurological procedure performed on the patient's cranium.

### Claim 9 (depends on 7)

The trajectory guiding apparatus as recited in claim 7, wherein the instrumentation column includes a vertical opening to the columnar passage to allow a tension member of the drive assembly to frictionally hold the elongate medical device within the columnar passage.

### Claim 10 (depends on 9)

The trajectory guiding apparatus as recited in claim 9, wherein the drive assembly is at least one of a manually operable drive assembly and a motorized drive assembly.

### Claim 11 (depends on 7)

The trajectory guiding apparatus as recited in claim 7, wherein each of the first and second gimbal drives is actuatable by at least one of a manually operable drive assembly and a motorized drive assembly.

### Claim 12 (depends on 7)

The trajectory guiding apparatus as recited in claim 7, wherein the base support, the pivotally rotatable stage, the vertical support, the slider assembly, the instrumentation column and each of the first and second gimbal drives are formed of biocompatible and magnetic resonance imaging (MRI) compatible materials.

### Claim 13 (depends on 7)

The trajectory guiding apparatus as recited in claim 7, wherein the elongate medical device comprises at least one of a deep brain stimulation (DBS) lead comprising a plurality of electrodes at a distal end, a biopsy instrumentation device, a catheter insertion device, an injection and aspiration device, a neurological endoscopy device, a microelectrode recording (MER) device, a macro stimulation device, a cannula device, a neurological ablation device, and a brain lesioning device.