# US 12,109,378 B2 · Digital external ventricular drain with integrated intracranial pressure monitor and cerebral spinal fluid monitor/pressure regulator

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- Number: US 12,109,378 B2
- Document ID: US12109378B2
- Status: Granted
- Kind: B2
- Application number: 16/765,618
- Filed: 2018-11-20
- Published: 2020-09-24
- Granted: 2024-10-08
- Earliest claimed: 2017-11-20
- Assignees: The Regents of the University of Michigan
- Applicants: The Regents of the University of Michigan
- Inventors: Rodney C. Daniels; Ashwin Belle
- Web page: https://patentgrep.com/patent/US12109378B2

## CPC

- A61M 27/006: {Cerebrospinal drainage; Accessories therefor, e.g. valves}
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/031: {Intracranial pressure}
- A61B 5/032: {Spinal fluid pressure}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61M 2205/18: with alarm
- A61M 2205/3337: Controlling, regulating pressure or flow by means of a valve by-passing a pump
- A61M 2205/3584: using modem, internet or Bluetooth®
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A dependent closed pressure vessel is fluidly coupled to an independent closed pressure vessel. A pressure sensor monitors pressure in the vessels to generate raw pressure measurement data. A flow meter monitors multidirectional rate of flow of fluid between the vessels and the volume of fluid flowing from the independent closed pressure vessel to generate raw rate of flow and raw volume measurement data. A pressure/flow regulator valve adjusts pressure in the dependent closed pressure vessel in response to a pressure set point signal generated in response to the raw pressure data, adjusts the rate of flow of fluid between the vessels in response to a rate of flow set point signal generated in response to the raw rate of flow data, and adjusts the rate of flow of fluid between the vessels in response to a volume set point signal generated in response to the raw volume data.

## Claims

### Claim 1

A device comprising:
a dependent closed pressure vessel adapted to fluidly couple to an independent closed pressure vessel and adapted to collect fluid from the independent closed pressure vessel;
a computing device;
a pressure sensor operatively coupled to the computing device and adapted to monitor pressure in the independent closed pressure vessel and in the dependent closed pressure vessel, adapted to generate raw pressure measurement data from the monitored pressure and adapted to provide the raw pressure measurement data to the computing device; and
a flow/pressure sensor downstream of the pressure sensor, with the dependent closed pressure vessel extending between the pressure sensor and the flow/pressure sensor, and operatively coupled to the computing device and adapted for monitoring multidirectional rate of flow of fluid between the independent closed pressure vessel and the dependent closed pressure vessel, adapted for measuring a volume of fluid flowing from the independent closed pressure vessel, adapted to generate raw data from which a rate of flow and a volume measurement data are determined, and adapted to provide the rate of flow and volume measurement data to the computing device;
wherein the computing device is adapted to generate a pressure set point signal in response to the raw pressure measurement data, adapted to generate a rate of flow set point signal in response to the rate of flow measurement data, and adapted to generate a volume set point signal in response to the volume measurement data,
the device further comprising a pressure/flow regulator valve operatively coupled to the computing device and adapted to adjust pressure in the dependent closed pressure vessel in response to the pressure set point signal, adapted to adjust the rate of flow of fluid between the independent closed pressure vessel and the dependent closed pressure vessel in response to the rate of flow set point signal, and adapted to adjust the rate of flow of fluid between the independent closed pressure vessel and the dependent closed pressure vessel in response to the volume set point signal.

### Claim 2 (depends on 1)

The device of claim 1, wherein the dependent closed pressure vessel is adapted to fluidly couple to the independent closed pressure vessel via an intraventricular catheter.

### Claim 3 (depends on 1)

The device of claim 1, wherein the dependent closed pressure vessel is adapted to fluidly couple to the independent closed pressure vessel via an external ventricular drain.

### Claim 4 (depends on 1)

The device of claim 1, wherein the dependent closed pressure vessel is a collecting reservoir for cerebral spinal fluid from the independent closed pressure vessel.

### Claim 5 (depends on 1)

The device of claim 1, wherein the independent closed pressure vessel is an intracranial/intraventricular space within a brain of a person, the pressure in the independent closed pressure vessel is intracranial pressure, and the fluid is cerebral spinal fluid.

### Claim 6 (depends on 1)

The device of claim 1, wherein the computing device is further adapted to automatically adjust the pressure set point signal in response to raw pressure measurement data from the pressure sensor when the pressure on the dependent closed pressure vessel meets a predefined threshold.

### Claim 7 (depends on 1)

The device of claim 1, wherein the computing device is further adapted to automatically adjust the rate of flow set point signal in response to a raw rate of flow measurement data from the flow/pressure sensor when the rate of flow of fluid meets a predefined threshold.

### Claim 8 (depends on 1)

The device of claim 1, wherein the computing device is further adapted to automatically adjust the rate of flow set point signal in response to a raw volume measurement data from the flow/pressure sensor when the fluid volume meets a predefined threshold.

### Claim 9 (depends on 1)

The device of claim 1, wherein the computing device is further adapted to adjust the pressure set point signal in response to a user defined pressure input, adjust the rate of flow set point signal in response to a user defined rate of flow input, and adjust the rate of flow set point signal in response to a user defined volume input.

### Claim 10 (depends on 1)

The device of claim 1, wherein the computing device comprises a real-time stream publication process to encode and encrypt messages with the raw measurement data from the pressure sensor and flow meter, and publish the messages to a subscription process.

### Claim 11 (depends on 1)

The device of claim 1, wherein the dependent closed pressure vessel, pressure sensor, flow meter, computing device, and pressure/flow regulator value are integrated.

### Claim 12 (depends on 1)

The device of claim 1, further comprising:
a sensor operatively coupled to the computing device and positioned on or proximate to the independent closed pressure vessel, the sensor adapted to monitor a position of the independent closed pressure vessel in at least a two-dimensional space, and adapted to provide data on the position of the independent pressure vessel to the computing device.

### Claim 13 (depends on 12)

The device of claim 12, wherein the sensor comprises one or more of the following: an altimeter, an accelerometer-gyroscope, and three dimensional positioning sensor.
