# US 11,432,731 B2 · Ultra-low profile wireless flow sensors to monitor hemodynamic alterations in the vascular system

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- Number: US 11,432,731 B2
- Document ID: US11432731B2
- Status: Granted
- Kind: B2
- Application number: 16/303,190
- Filed: 2017-05-26
- Published: 2019-06-06
- Granted: 2022-09-06
- Earliest claimed: 2016-05-27
- Assignees: University of Pittsburgh—Of the Commonwealth System of Higher Education; Virginia Commonwealth University
- Applicants: University of Pittsburgh-Of the Commonwealth System of Higher Education; Virginia Commonwealth University
- Inventors: Young Jae Chun; Brian T. Jankowitz; Sung Kwon Cho; Yanfei Chen; Woon-Hong Yeo; Yongkuk Lee; Connor Howe
- Web page: https://patentgrep.com/patent/US11432731B2

## CPC

- A61B 5/026: Measuring blood flow {(A61B3/1233, A61B3/1241 take precedence)}
- A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)}
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/6852: {Catheters}
- A61B 5/6862: {Stents}
- A61B 2562/12: Manufacturing methods specially adapted for producing sensors for in-vivo measurements
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The invention relates to endovascular medical implant devices, systems and methods that including a sensing device and a flow diverter device, which are effective to monitor intra-/post-operative hemodynamic properties in the location of a cerebral aneurysm and, hemodynamic alterations following placement of the system for treating ischemic diseases in carotid, coronary and peripheral arteries. The sensing device includes wireless, non-thrombogenic, highly stretchable, ultra-low profile flow sensors.

## Claims

### Claim 1

An endovascular medical implant system positioned in a vascular system of a patient, comprising:
a flow diverting device, comprising a thin film nitinol; and
a wireless, non-thrombogenic, highly stretchable, ultra-low profile, microflow capacitive sensor component, comprising:
a first metallic layer comprising an etched overall pattern, connected to at least a portion of the flow diverting device;
a dielectric elastomer layer deposited on the first metallic layer; and
a second metallic layer comprising an etched overall pattern, deposited on the dielectric elastomer layer,
wherein the first metallic layer, the dielectric elastomer layer and the second metallic layer are in a stacked configuration, and
wherein the capacitive sensor component is structured to produce a capacitive change when the capacitive sensor component is deflected by a flow of blood and the dielectric elastomer layer is deformed, and structured to measure a flow rate of the blood.

### Claim 2 (depends on 1)

The system of claim 1, wherein each of the first and second metallic layers is selected from the group consisting of gold, magnesium, nitinol and blends thereof.

### Claim 3 (depends on 1)

The system of claim 1, wherein the flow diverting device comprises:
a framework composed of a biocompatible material; and
a cover composed of the thin film nitinol that is attached to at least a portion of the framework.

### Claim 4 (depends on 1)

The system of claim 1, wherein the dielectric elastomer is polydimethylsiloxane.

### Claim 5 (depends on 1)

The system of claim 1, wherein the flow diverting device is selected from the group consisting of a coil and a stent.

### Claim 6 (depends on 1)

The system of claim 1, wherein the flow diverting device is composed of a polymer.

### Claim 7

The system of claim4 1 wherein the etched overall pattern is a meandering curved mesh pattern.

### Claim 8 (depends on 1)

The system of claim 1, further comprising a transmitter device, a flexible antenna and an external data receiver device, to continually transfer data through the antenna to the receiver device.

### Claim 9 (depends on 1)

The system of claim 1, wherein the sensor component has a stacked configuration, comprising:
a carrying substrate;
a polymer deposited on the carrying substrate;
polyimide deposited on the polymer;
the first metallic layer deposited on the polyimide, having an etched pattern;
the dielectric elastomer deposited on the first metallic layer;
the second metallic layer deposited on the dielectric elastomer, having an etched pattern; and
an encapsulate elastomer deposited as a final layer.

### Claim 10

A method of measuring blood flow in a vascular system of a patient body, comprising:
forming an integrated sensor and flow diverter, comprising:
fabricating a flow diverter, comprising:
forming a framework having a surface and composed of a biocompatible material; and
connecting a thin film nitinol cover to at least a portion of the surface of the framework;
fabricating a microflow sensor component, comprising:
forming a first metallic layer comprising an etched overall pattern;
connecting the first metallic layer to at least a portion of the flow diverting device;
depositing a dielectric elastomer on the first metallic layer; and
depositing a second metallic layer on the dielectric elastomer comprising an etched overall pattern;
connecting the microflow sensor component to at least a portion of the flow diverter to form the integrated sensor and flow diverter,
wherein the first metallic layer, the dielectric elastomer and the second metallic layer are in a stacked configuration;
deploying the integrated sensor and flow diverter in the patient body to a target site;
deflecting the microflow sensor component with a flow of blood and deforming the dielectric elastomer layer, resulting in the microflow sensor component producing a capacitive change and measuring a flow rate of the blood; and
transferring data in real time from the integrated sensor and flow diverter to an external data receiving device.

### Claim 11 (depends on 10)

The method of claim 10, further comprising etching the first metallic layer and the second metallic layer to form an overall pattern.

### Claim 12 (depends on 10)

The method of claim 10, wherein the deploying of the integrated sensor and flow diverter is achieved by employing a microdelivery catheter.

### Claim 13 (depends on 10)

The method of claim 10, wherein the target site is in an aneurysm or in a blood vessel adjacent the aneurysm.
