# US 11,992,596 B2 · Medical device dislodgment detection

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,992,596 B2
- Document ID: US11992596B2
- Status: Granted
- Kind: B2
- Application number: 18/056,042
- Filed: 2022-11-16
- Published: 2023-03-09
- Granted: 2024-05-28
- Earliest claimed: 2019-04-15
- Assignees: Mozarc Medical US LLC
- Applicants: Mozarc Medical US LLC
- Inventors: Daniel Bloomberg; VenKatesh Manda
- Web page: https://patentgrep.com/patent/US11992596B2

## CPC

- A61M 1/3656: {Monitoring patency or flow at connection sites; Detecting disconnections}
- A61M 1/1601: {Control or regulation}
- A61M 1/3661: {for haemodialysis}
- A61M 1/16: with membranes
- A61M 1/3655: {Arterio-venous shunts or fistulae}
- A61M 2025/0002: {with a pressure sensor at the distal end}
- A61M 2205/0244: Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
- A61M 2205/15: Detection of leaks
- A61M 2205/18: with alarm
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/581: by audible feedback
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- 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

In examples described herein, a system includes an elongate member configured to be introduced into vasculature of a patient. The elongate member includes a pressure sensor configured to generate a pressure signal indicative of pressure in the vasculature adjacent the needle. The system includes processing circuitry configured to receive the pressure signal from the pressure sensor, detect, based on the pressure signal, dislodgment of the elongate member from the vasculature, and generate an output in response to detecting the dislodgment of the elongate member from the vasculature.

## Claims

### Claim 1

A method comprising:
receiving, by processing circuitry, a pressure signal generated by a pressure sensor on an elongate member configured to be introduced into vasculature of a patient, the pressure signal being indicative of pressure adjacent the elongate member;
detecting, by the processing circuitry and based on the pressure signal, dislodgment of the elongate member from the vasculature, wherein detecting the dislodgment of the elongate member comprises:
determining the pressure adjacent the elongate member based on the pressure signal; and
comparing the pressure adjacent the elongate member with a threshold pressure; and
generating, by the processing circuitry, an output in response to detecting the dislodgment of the elongate member from the vasculature.

### Claim 2 (depends on 1)

The method of claim 1, wherein the elongate member comprises a venous needle fluidically coupled to a dialysis unit, the dialysis unit being configured to dialyze a volume of fluid extracted from the vasculature through an arterial needle and return the volume of dialyzed fluid to the vasculature through the venous needle.

### Claim 3 (depends on 2)

The method of claim 2, wherein generating the output comprises controlling the dialysis unit based on detection of the dislodgment of the venous needle.

### Claim 4 (depends on 3)

The method of claim 3, wherein controlling the dialysis unit comprises causing a dialysis pump of the dialysis unit to stop extracting fluid from the vasculature via the arterial needle.

### Claim 5 (depends on 1)

The method of claim 1, wherein generating the output comprises presenting, via a user interface, a notification that instructs a user to reposition the elongate member in the vasculature.

### Claim 6 (depends on 1)

The method of claim 1, wherein detecting the dislodgment of the elongate member comprises detecting the dislodgment of the elongate member in response to determining the pressure adjacent the elongate member is greater than or equal to the threshold pressure.

### Claim 7 (depends on 6)

The method of claim 6, wherein the threshold pressure is greater than an atmospheric pressure.

### Claim 8 (depends on 1)

The method of claim 1, wherein the pressure sensor comprises a micro-electro-mechanical systems (MEMS) pressure sensor.

### Claim 9 (depends on 1)

The method of claim 1, further comprising detecting a venous stenosis in the vasculature based on the pressure signal.

### Claim 10 (depends on 9)

The method of claim 9, wherein the threshold pressure comprises a first threshold pressure, and wherein detecting the venous stenosis comprises:
detecting the venous stenosis in response to determining the pressure adjacent the elongate member is greater than or equal to a second threshold pressure.

### Claim 11 (depends on 9)

The method of claim 9, wherein detecting the venous stenosis comprises:
determining a flow rate through the vasculature based on the pressure signal;
detecting a threshold pressure change in the vasculature based on the pressure signal;
detecting a threshold flow rate change in the vasculature based on the determined flow rate; and
detecting the venous stenosis in the vasculature in response to detecting the threshold pressure change and the threshold flow rate change.

### Claim 12 (depends on 11)

The method of claim 11, further comprising modifying an operation of a dialysis unit in response to detecting the venous stenosis, the dialysis unit being configured to deliver fluid to the patient via the elongate member.

### Claim 13 (depends on 1)

The method of claim 1, wherein receiving the pressure signal generated by the pressure sensor comprises receiving the pressure signal generated by the pressure sensor on the elongate member configured to be introduced into an arteriovenous fistula or an arteriovenous graft of the patient.

### Claim 14 (depends on 1)

A computer-readable medium comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to perform the method of claim 1.

### Claim 15

A method comprising:
receiving, by processing circuitry, a pressure signal generated by a pressure sensor on an elongate member configured to be introduced into vasculature of a patient, the pressure signal being indicative of pressure adjacent the elongate member, wherein the pressure signal comprises an analog pressure signal;
detecting, by the processing circuitry and based on the pressure signal, dislodgment of the elongate member from the vasculature, wherein detecting the dislodgment of the elongate member comprises:
determining the analog pressure signal does not include a pulse pressure wave component, the pulse pressure wave being indicative of a pulse pressure of the patient, wherein determining the analog pressure signal does not include the pulse wave component comprises:
detecting a dialysis pump pressure wave component in the analog pressure signal,
generating a residual wave by at least filtering the dialysis pump pressure wave component from the analog pressure signal, and
determining the residual wave does not include the pulse pressure wave component; and
detecting the dislodgment of the elongate member in response to determining the analog pressure signal does not include the pulse pressure wave component; and
generating, by the processing circuitry, an output in response to detecting the dislodgment of the elongate member from the vasculature.

### Claim 16 (depends on 15)

The method of claim 15, wherein the elongate member comprises a venous needle fluidically coupled to a dialysis unit, the dialysis unit being configured to dialyze a volume of fluid extracted from the vasculature through an arterial needle and return the volume of dialyzed fluid to the vasculature through the venous needle.

### Claim 17 (depends on 16)

The method of claim 16, wherein generating the output comprises controlling the dialysis unit based on detection of the dislodgment of the venous needle.

### Claim 18

A method comprising:
receiving, by processing circuitry, a pressure signal generated by a pressure sensor on an elongate member configured to be introduced into vasculature of a patient, the pressure signal being indicative of pressure adjacent the elongate member;
receiving, by the processing circuitry, a reference pressure signal indicative of a reference pressure external to the vasculature;
detecting, by the processing circuitry and based on the pressure signal, dislodgment of the elongate member from the vasculature, wherein detecting the dislodgment of the elongate member from the vasculature comprises detecting the dislodgment of the elongate member based on the pressure signal and the reference pressure signal; and
generating, by the processing circuitry, an output in response to detecting the dislodgment of the elongate member from the vasculature.

### Claim 19 (depends on 18)

The method of claim 18, wherein detecting the dislodgment of the elongate member based on the pressure signal and the reference pressure signal comprises:
determining, based on the pressure signal and the reference pressure signal, a differential pressure; and
comparing the differential pressure with a threshold pressure.

### Claim 20 (depends on 18)

The method of claim 18, wherein detecting the dislodgment of the elongate member based on the pressure signal and the reference pressure signal comprises:
determining, based on the pressure signal and the reference pressure signal, a differential pressure;
determining a rate of change of the differential pressure over time; and
comparing the rate of change of the differential pressure with a threshold rate of change.

### Claim 21 (depends on 18)

The method of claim 18, wherein the elongate member comprises a venous needle fluidically coupled to a dialysis unit, the dialysis unit being configured to dialyze a volume of fluid extracted from the vasculature through an arterial needle and return the volume of dialyzed fluid to the vasculature through the venous needle.

### Claim 22 (depends on 21)

The method of claim 21, wherein generating the output comprises controlling the dialysis unit based on detection of the dislodgment of the venous needle.

### Claim 23

A system comprising:
an elongate member configured to be introduced into vasculature of a patient, the elongate member comprising means for generating a pressure signal indicative of pressure adjacent the elongate member; and
means for detecting dislodgment of the elongate member from the vasculature based on the pressure signal, wherein the means for detecting dislodgment of the elongate member detects the dislodgment of the elongate member in response to determining the pressure adjacent the elongate member based on the pressure signal and determining the pressure is greater than or equal to a threshold pressure; and
means for generating an output in response to detecting the dislodgment of the needle from the vasculature.

### Claim 24 (depends on 23)

The system of claim 23, wherein the pressure signal comprises an analog pressure signal, and wherein the means for detecting dislodgment of the elongate member comprises:
means for determining the analog pressure signal does not include a pulse pressure wave component, the pulse pressure wave being indicative of a pulse pressure of the patient; and
means for detecting the dislodgment of the elongate member in response to determining the analog pressure signal does not include the pulse pressure wave component.
