# US 12,594,092 B2 · Fly by wire control for atherectomy

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- Number: US 12,594,092 B2
- Document ID: US12594092B2
- Status: Granted
- Kind: B2
- Application number: 17/894,059
- Filed: 2022-08-23
- Published: 2023-04-20
- Granted: 2026-04-07
- Earliest claimed: 2021-10-20
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Daniel Frank Massimini; Michael Kaland; Corydon Carlson; Jarrod Kenneth Neuharth
- Web page: https://patentgrep.com/patent/US12594092B2

## CPC

- A61B 17/320758: {with a rotating cutting instrument, e.g. motor driven (A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002)}
- A61B 34/25: {User interfaces for surgical systems}
- A61B 34/76: {Manipulators having means for providing feel, e.g. force or tactile feedback}
- A61B 2017/00075: {Motion}
- A61B 2017/00199: {with a console, e.g. a control panel with a display}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2017/00398: {using powered actuators, e.g. stepper motors, solenoids}
- A61B 2017/320004: {abrasive}
- A61B 2034/301: {for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes}
- A61B 2090/061: {for measuring dimensions, e.g. length}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/08021: {of the patient or his organs}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An atherectomy system includes a user interface that an operator engages with in order to indicate requested movement of a drive assembly. One or more sensors are adapted to ascertain one or more conditions of the drive assembly and to output one or more condition signals to a controller that is operably coupled with the operator assembly and the drive assembly. The controller is adapted to receive the request signal from the operator assembly and the one or more condition signals, to determine a command signal in response to the received request signal and the received one or more condition signals, and provide the command signal to the drive assembly. The drive assembly is adapted to move relative to the advancer assembly in accordance with the command signal.

## Claims

### Claim 1

An atherectomy system, comprising:
an advancer assembly;
a drive assembly adapted to translate relative to the advancer assembly, the drive assembly including:
a rotatable drive shaft operably coupled with the drive assembly such that the rotatable drive shaft translates with the drive assembly; and
an atherectomy burr coupled to the drive shaft, the drive shaft adapted to rotate the atherectomy burr at speeds exceeding 100,000 revolutions per minute;
wherein the drive shaft and the atherectomy burr are adapted to be advanced through a patient's vasculature to reach a treatment site within the patient's vasculature;
an operator assembly including a user interface that an operator engages with in order to indicate requested translation of the drive assembly, the user interface configured to output a request signal indicating requested translation of the drive assembly;
one or more sensors adapted to ascertain one or more conditions of the drive assembly and to output one or more condition signals;
a controller operably coupled with the operator assembly and the drive assembly, the controller adapted to:
receive the request signal from the operator assembly and the one or more condition signals;
determine a command signal in response to the received request signal and the received one or more condition signals; and
provide the command signal to the drive assembly;
wherein the drive assembly is adapted to translate relative to the advancer assembly in accordance with the command signal.

### Claim 2 (depends on 1)

The atherectomy system of claim 1, further comprising a servo motor that is adapted to translate the drive assembly relative to the advancer assembly in response to the command signal.

### Claim 3 (depends on 2)

The atherectomy system of claim 2, wherein one of the one or more sensors comprises a servo force sensor that is adapted to provide the controller with a force signal indicating resistance to translation of the drive assembly relative to the advancer assembly.

### Claim 4 (depends on 2)

The atherectomy system of claim 2, wherein the drive assembly further comprises a drive motor adapted to rotate the rotatable drive shaft.

### Claim 5 (depends on 4)

The atherectomy system of claim 4, wherein one of the one or more sensors comprises a drive motor sensor that is adapted to provide the controller with a drive motor condition signal indicating a current operating condition of the drive motor.

### Claim 6 (depends on 2)

The atherectomy system of claim 2, wherein one of the one or more sensors comprises a drive assembly position sensor that is adapted to provide the controller with a drive assembly position signal indicating a relative position of the drive assembly.

### Claim 7 (depends on 2)

The atherectomy system of claim 2, further comprising a feedback generator that is adapted to change a feel of the user interface in order to indicate a sensed condition of the drive assembly.

### Claim 8 (depends on 7)

The atherectomy system of claim 7, wherein the feedback generator comprises an active feedback generator.

### Claim 9 (depends on 8)

The atherectomy system of claim 8, wherein the controller is further adapted to:
determine an active feedback generation signal based upon signals received from the one or more sensors adapted to ascertain one or more conditions of the drive assembly; and
provide the active feedback generation signal to the active feedback generator;
wherein the active feedback generator is adapted to generate feedback to the user interface in accordance with the active feedback generation signal.

### Claim 10 (depends on 9)

The atherectomy system of claim 9, wherein the controller is further adapted to:
determine the active feedback generation signal in accordance with a first set of tuning parameter values when the operator is requesting that the drive assembly move in an anterograde ablation direction; and
determine the active feedback generation signal in accordance with a second set of tuning parameter values, different from the first set of tuning parameter values, when the operator is requesting that the drive assembly move in a retrograde ablation direction.

### Claim 11 (depends on 10)

The atherectomy system of claim 10, wherein the controller is further adapted to provide a first level of feedback to the user interface via the active feedback generator when the operator is requesting low force movement of the drive assembly and to provide a greater level of feedback to the user interface via the active feedback generator when the operator is requesting high force movement of the drive assembly.

### Claim 12 (depends on 10)

The atherectomy system of claim 10, wherein the controller is further adapted to provide a first level of feedback to the user interface via the active feedback generator when the operator is requesting that the drive assembly move in the anterograde ablation direction and to provide a greater level of feedback to the user interface via the active feedback generator when the operator is requesting that the drive assembly move in the retrograde ablation direction.

### Claim 13 (depends on 1)

The atherectomy system of claim 1, wherein the atherectomy burr includes:
a tapered body including a proximal taper and a distal taper;
a first ablating surface disposed on the proximal taper for retrograde ablation; and
a second ablating surface disposed on the distal taper for anterograde ablation.

### Claim 14 (depends on 1)

The atherectomy system of claim 1, wherein the controller is further adapted to engage a fail-safe operation in the event that communication between the controller and any of the one or more sensors is lost.

### Claim 15 (depends on 1)

The atherectomy system of claim 1, wherein the operator assembly further comprises a user interface position sensor that provides the controller with a signal indicating a current position of the user interface.

### Claim 16

An atherectomy system that is adapted for both anterograde direction ablation and retrograde direction ablation, the atherectomy system comprising:
an operator assembly including:
a user interface that an operator engages with in order to indicate requested translation of a drive assembly, the user interface configured to output a request signal indicating requested translation of the drive assembly;
a first controller operably coupled with the operator assembly and adapted to receive the request signal from the user interface; and
an advancer assembly including:
a drive assembly adapted to translate relative to the advancer assembly, the drive assembly including:
a drive shaft operably coupled with the drive assembly such that the drive shaft translates with the drive assembly;
a drive motor adapted to rotate the drive shaft at atherectomy speeds; and
an atherectomy burr coupled to the drive shaft;
one or more sensors adapted to ascertain one or more conditions of the drive assembly and to output one or more condition signals;
a second controller operably coupled with the operator assembly and the drive assembly, the second controller adapted to:
receive the request signal from the first controller and the one or more condition signals;
determine a command signal in response to the received request signal and the received one or more condition signals; and
provide the command signal to the drive assembly;
wherein the drive assembly is adapted to translate relative to the advancer assembly in accordance with the command signal.

### Claim 17 (depends on 16)

The atherectomy system of claim 16, wherein the first controller and the second controller are each adapted to communicate wirelessly with each other.

### Claim 18 (depends on 16)

The atherectomy system of claim 16, wherein the operator assembly further comprises an active feedback generator operably coupled with the user interface.

### Claim 19 (depends on 16)

The atherectomy system of claim 16, wherein the atherectomy burr includes:
a tapered body including a proximal taper and a distal taper;
a first ablating surface disposed on the proximal taper for retrograde ablation; and
a second ablating surface disposed on the distal taper for anterograde ablation.

### Claim 20

An atherectomy system, comprising:
an advancer assembly;
a drive assembly adapted to translate relative to the advancer assembly, the drive assembly including:
a drive shaft operably coupled with the drive assembly such that the drive shaft translates with the drive assembly;
a drive motor adapted to rotate the drive shaft at atherectomy speeds; and
an atherectomy burr coupled to the drive shaft;
an operator assembly including:
a user interface that an operator engages with in order to indicate requested translation of the drive assembly, the user interface configured to output a request signal indicating requested translation of the drive assembly;
an active feedback generator operably coupled with the user interface, the active feedback generator adapted to alter a feel of the user interface in response to a received feedback signal;
one or more sensors adapted to ascertain one or more conditions of the drive assembly and to output one or more condition signals;
a controller operably coupled with the operator assembly and the drive assembly, the controller adapted to:
receive the request signal from the operator assembly and the one or more condition signals;
determine a command signal in response to the received request signal and the received one or more condition signals;
determine the feedback signal;
provide the command signal to the drive assembly; and
provide the feedback signal to the active feedback generator;
wherein the drive assembly is adapted to translate relative to the advancer assembly in accordance with the command signal.
