# US 10,478,153 B2 · System and method for monitoring device engagement

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- Number: US 10,478,153 B2
- Document ID: US10478153B2
- Status: Granted
- Kind: B2
- Application number: 15/206,394
- Filed: 2016-07-11
- Published: 2016-11-03
- Granted: 2019-11-19
- Earliest claimed: 2013-05-14
- Assignees: ACIST Medical Systems, Inc.
- Applicants: ACIST Medical Systems, Inc.
- Inventors: Arcadi Elbert
- Web page: https://patentgrep.com/patent/US10478153B2

## CPC

- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/4209: {by using holders, e.g. positioning frames}
- A61B 8/4461: {Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe}
- A61B 8/461: {Displaying means of special interest}
- A61B 8/54: {Control of the diagnostic device}
- A61B 8/58: {Testing, adjusting or calibrating the diagnostic device}
- A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers}
- A61B 2560/0266: for monitoring or limiting apparatus function
- A61B 2560/0276: Determining malfunction
- A61B 2562/228: Sensors with optical connectors
- 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)}

## Abstract

An intravenous ultrasound (IVUS) system can include a catheter and a translation mechanism for translating the catheter. Engagement between the catheter and the translation mechanism may be detected, and the translation mechanism can be placed in a connected or disconnected mode, accordingly. When in connected mode, certain IVUS operations may be enabled when compared to disconnected mode, wherein such operations may be disabled. Thus, some embodiments may ensure proper engagement between the catheter and the translation mechanism prior to allowing certain IVUS operations to be carried out.

## Claims

### Claim 1

An intravascular ultrasound (IVUS) system, comprising:
an IVUS catheter comprising:
a sheath,
a drive cable extending through the sheath being coupled to an IVUS transducer at a distal end,
a connector at a proximal end of the IVUS catheter, the connector being coupled to a proximal end of the drive cable, and
an anchor assembly positioned near a proximal end of the sheath, the anchor assembly being separate from the connector of the IVUS catheter; and
a translation mechanism comprising:
a catheter interface configured to electrically and mechanically interface with the connector of the IVUS catheter,
an anchor port separate from the catheter interface and configured to receive the anchor assembly of the IVUS catheter in order to anchor the anchor assembly of the IVUS catheter to the translation mechanism, and
a sensor positioned proximate the anchor port, the sensor outputting a signal representative of whether or not the anchor assembly of the IVUS catheter is anchored to the anchor port of the translation mechanism to enable a controller to place the translation mechanism in a connected mode if the anchor assembly is anchored to the anchor port or in a disconnected mode if the anchor assembly is not anchored to the anchor port, wherein
the translation mechanism is configured to translate the catheter interface relative to the anchor port.

### Claim 2 (depends on 1)

The IVUS system of claim 1, wherein the sensor comprises an optical sensor.

### Claim 3 (depends on 2)

The IVUS system of claim 2, wherein the anchor port comprises a notch formed in a portion of the translation mechanism, the notch having a first side and a second side opposite the first side, and wherein the optical sensor comprises a photo emitter positioned in the first side of the notch and a photo detector positioned in the second side of the notch such that, when the anchor assembly of the IVUS catheter is anchored to the anchor port of the translation mechanism, the anchor assembly blocks the light from the photo emitter from reaching the photo detector.

### Claim 4 (depends on 1)

The IVUS system of claim 1, wherein the sensor comprises a mechanical switch.

### Claim 5 (depends on 1)

The IVUS system of claim 1, further comprising the controller that is configured to determine whether to place the translation mechanism in the connected mode or in the disconnected mode.

### Claim 6 (depends on 5)

The IVUS system of claim 5, wherein at least one IVUS operation is enabled when the translation mechanism is in the connected mode and is disabled when the translation mechanism is in the disconnected mode.

### Claim 7 (depends on 6)

The IVUS system of claim 6, wherein the at least one IVUS operation comprises performing a pullback operation via the translation mechanism.

### Claim 8 (depends on 5)

The IVUS system of claim 5, further comprising a display in communication with the controller and being configured to present a graphical representation, and wherein the presented graphical representation includes an indication representing whether or not the anchor assembly of the IVUS catheter is anchored to the anchor port of the translation mechanism.

### Claim 9 (depends on 1)

The IVUS system of claim 1, wherein the IVUS catheter comprises a memory including catheter information, and wherein the controller communicates with the memory of the IVUS catheter via the connector and the catheter interface.

### Claim 10 (depends on 9)

The IVUS system of claim 9, wherein the controller communicates with the memory of the IVUS catheter only if the anchor assembly of the IVUS catheter is anchored to the anchor port of the translation mechanism.

### Claim 11 (depends on 1)

The IVUS system of claim 1, wherein the translation mechanism comprises a patient interface module (PIM) and a linear translation system (LTS), the LTS being configured to translate the PIM between distal and proximal positions, and wherein the anchor port of the translation mechanism is positioned on the LTS and the catheter interface of the translation mechanism is positioned on the PIM.

### Claim 12

An intravascular ultrasound (IVUS) system comprising:
an anchor sensor;
an IVUS catheter having
a sheath,
a drive cable positioned within the sheath, the drive cable being coupled to an IVUS transducer at a distal end,
a connector located at a proximal end of the drive cable, the connector being separate from the sheath, and
an anchor assembly positioned near a proximal end of the sheath,
a translation mechanism comprising a catheter interface and an anchor port separate from the catheter interface, the translation mechanism being configured to translate the catheter interface relative to the anchor port, and wherein the catheter interface being configured interface with the IVUS catheter via the connector of the IVUS catheter, and wherein the anchor port being configured to engage with the IVUS catheter via the anchor assembly of the IVUS catheter; and
a controller in communication with the anchor sensor and configured to:
measure a first output from the anchor sensor corresponding to engagement between the anchor assembly of the IVUS catheter and the translation mechanism;
determine, via the first output, if the anchor assembly of the IVUS catheter is anchored to the anchor port of the translation mechanism;
place the translation mechanism in a connected mode if the anchor assembly is anchored to the anchor port or in a disconnected mode if the anchor assembly is not anchored to the anchor port; and
provide a signal to a user alerting the user if the translation mechanism is in the disconnected mode.

### Claim 13 (depends on 12)

The IVUS system of claim 12, wherein providing the signal to the user alerting the user that the translation mechanism is in the disconnected mode comprises sounding an audible alarm.

### Claim 14 (depends on 12)

The IVUS system of claim 12 further comprising a display, and wherein providing the signal to the user alerting the user if the translation mechanism is in the disconnected mode comprises indicating on the display that the anchor assembly is not anchored to the anchor port.

### Claim 15 (depends on 14)

The IVUS system of claim 14, wherein the controller is configured to generate on the display information that includes a connection status of the anchor assembly and the anchor port.

### Claim 16 (depends on 12)

The IVUS system of claim 12, wherein the anchor sensor comprises a sensor positioned proximate the anchor port, the sensor outputting a signal representative of whether or not the anchor assembly of the IVUS catheter is anchored to the anchor port of the translation mechanism.

### Claim 17 (depends on 16)

The IVUS system of claim 16, wherein the sensor comprises an optical sensor and/or a mechanical switch.

### Claim 18

A method of operating an intravascular ultrasound (IVUS) system that includes:
a translation mechanism comprising a catheter interface and an anchor port separate from the catheter interface, the translation mechanism being configured to translate the catheter interface relative to the anchor port, and
an IVUS catheter having
a sheath including an anchor assembly positioned near a proximal end of the sheath, the anchor assembly being configured to engage the anchor port of the translation mechanism,
a drive cable positioned within the sheath, the drive cable being coupled to an IVUS transducer at a distal end,
a connector located at a proximal end of the drive cable, the connector being separate from the sheath and configured to provide an electrical and mechanical interface between the IVUS catheter and the catheter interface of the translation mechanism, and
a sensor positioned proximate the anchor port, the sensor outputting a signal representative of whether or not the anchor assembly of the IVUS catheter is anchored to the anchor port of the translation mechanism, the method comprising:
receiving the signal output from the sensor;
determining if the anchor assembly of the IVUS catheter is anchored to the anchor port of the translation mechanism;
preventing one or more IVUS tasks of the IVUS system if the anchor assembly of the IVUS catheter is not anchored to the anchor port of the translation mechanism; and
enabling one or more IVUS tasks of the IVUS system if the anchor assembly of the IVUS catheter is anchored to the anchor port of the translation mechanism.

### Claim 19 (depends on 18)

The method of claim 18, wherein preventing one or more IVUS tasks comprises disabling an operation of the IVUS system.

### Claim 20 (depends on 18)

The method of claim 18, wherein preventing one or more IVUS tasks comprises alerting a user that the anchor assembly of the IVUS catheter is not anchored to the anchor port of the translation mechanism.
