# US 12,599,304 B2 · Configurable hardware platform for physiological monitoring of a living body

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- Number: US 12,599,304 B2
- Document ID: US12599304B2
- Status: Granted
- Kind: B2
- Application number: 18/349,544
- Filed: 2023-07-10
- Published: 2023-11-16
- Granted: 2026-04-14
- Earliest claimed: 2019-07-03
- Assignees: Bardy Diagnostics, Inc.
- Applicants: Bardy Diagnostics, Inc.
- Inventors: Jason Felix; Joshua Djon Green; Corey B. Williamson; Gust H. Bardy
- Web page: https://patentgrep.com/patent/US12599304B2

## CPC

- A61B 5/0006: {ECG or EEG signals}
- H04Q 9/00: Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom
- A61B 5/0022: {Monitoring a patient using a global network, e.g. telephone networks, internet}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/02055: {Simultaneously evaluating both cardiovascular condition and temperature}
- A61B 5/073: {Intestinal transmitters}
- A61B 5/076: {Permanent implantation}
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/29: for permanent or long-term implantation
- A61B 5/6861: {Capsules, e.g. for swallowing or implanting}
- G16H 40/67: for remote operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 80/00: ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
- H04L 12/2825: {Reporting to a device located outside the home and the home network (access arrangements H04L12/2856; for remote control or remote monitoring of applications H04L67/025; telephonic communication systems adapted for combination with telemetering systems H04M11/002)}
- H04Q 9/02: Automatically-operated arrangements
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- A61B 5/087: Measuring breath flow
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14551: {for measuring blood gases}
- A61B 5/14552: {Details of sensors specially adapted therefor}
- A61B 2560/0204: of power management
- A61B 2560/0219: of externally powered implanted units
- A61B 2560/0468: Built-in electrodes
- A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
- H04Q 2209/43: using wireless personal area networks [WPAN], e.g. 802.15, 802.15.1, 802.15.4, Bluetooth® or Zigbee®
- H04Q 2209/886: using energy harvesting, e.g. solar, wind or mechanical
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- H04Q: SELECTING (switches, relays, selectors H01H; wireless communication networks H04W)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H04L: TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION (arrangements common to telegraphic and telephonic communication H04M)

## Abstract

An implantable medical device is disclosed. A housing includes a hollow body forming a first electrode on an outer surface with end caps affixed to opposite ends, one end cap forming a second electrode. A microcontroller circuit is provided and includes a microcontroller operable under program instructions stored within a non-volatile memory device. An analog front end is interfaced to the electrodes to sense electrocardiographic signals. A transceiver circuit is operable to wirelessly communicate with an external data device. The program instructions define instructions to continuously sample the electrocardiographic signals into the non-volatile memory device and to offload the non-volatile memory device to the external data device. A receiving coil and a charging circuit are operable to charge an onboard power source for the microcontroller circuit.

## Claims

### Claim 1

An implantable medical device (IMD), comprising:
a housing comprising a hollow body forming a first sensing electrode on an outer surface and a first end cap and a second end cap affixed to opposite ends of the hollow body, wherein the first end cap comprises an electrically conductive semi sphere that serves as a second sensing electrode, the first sensing electrode comprising an electrically conductive surface that is an integral part of a portion of the outer surface of the hollow body and that is separated from the first end cap by an electrically insulated further portion of the outer surface of the hollow body; and
an analog front end within the housing and electrically interfaced to the first and the second sensing electrodes and operable to sense electrocardiographic signals via the first and the second sensing electrodes;
a transceiver circuit within the housing and operable to wirelessly communicate with an external device;
a memory within the housing; and
a microcontroller within the housing and operable under program instructions to continuously sample at least some of the electrocardiographic signals, to store the samples into the memory, and to offload the memory to the external device via the transceiver circuit.

### Claim 2 (depends on 1)

The IMD in accordance with claim 1, wherein the second end cap comprises an electrically insulated semi sphere formed from a medical implantation-safe grade material comprising at least one of an acrylic, glass, ruby crystal, or ceramic.

### Claim 3 (depends on 1)

The IMD in accordance with claim 1, further comprising a high frequency antenna interfaced to the transceiver circuit within the second end cap.

### Claim 4 (depends on 3)

The IMD in accordance with claim 3, further comprising:
a filler material within the second end cap and holding the high frequency antenna in place.

### Claim 5 (depends on 1)

The IMD in accordance with claim 1, wherein the electrocardiographic signals are providing to the microcontroller as an analog signal.

### Claim 6 (depends on 1)

The IMD in accordance with claim 1, further comprising a set of concave dimples formed along an inside shelf surface of the one end cap.

### Claim 7 (depends on 6)

The IMD in accordance with claim 6, the first end cap further comprising:
an insulator ring bonded to the electrically conductive semi sphere; and
a metallic weld ring bonded to the insulator ring and to the hollow body.

### Claim 8 (depends on 7)

The IMD in accordance with claim 7, the metallic weld ring comprising a chamfered edge bonded to the hollow body.

### Claim 9 (depends on 7)

The IMD in accordance with claim 7, wherein the concave dimples facilitate bonding of the electrically semi sphere to the insulator ring.

### Claim 10 (depends on 7)

The IMD in accordance with claim 7, wherein the first end cap is filled with a filler comprising one or more of an epoxy and silicon.

### Claim 11 (depends on 10)

The IMD in accordance with claim 10, wherein the insulator ring comprises one or more of a ruby, glass, and ceramic and at least some of the filler is bonded to the insulator ring.

### Claim 12 (depends on 7)

The IMD in accordance with claim 7, wherein the electrically conductive semi sphere, the insulator ring, and the metallic weld ring are bonded together using one of pressure fitting, brazing, laser welding, and electron beam welding.

### Claim 13 (depends on 1)

The IMD in accordance with claim 1, further comprising:
a cavity formed inside the first end cap;
a circumferential groove longitudinally defined within the cavity, wherein a circuit board mounts within the groove.

### Claim 14 (depends on 13)

The IMD in accordance with claim 13, further comprising:
the circuit board comprising edges plated with a set of electrically conductive coatings.

### Claim 15 (depends on 14)

The IMD in accordance with claim 14, wherein the electrically conductive coatings comprise a copper coating applied on the edges, a nickel coating applied on top of the copper coating, a palladium coating applied on top of nickel coating, and a gold coating applied on top of the palladium coating.

### Claim 16 (depends on 14)

The IMD in accordance with claim 14, wherein the circuit board comprises copper traces and the electrically conductive semi sphere comprises titanium and the electrically conductive coatings inhibit a galvanic reaction between the copper traces and the titanium.

### Claim 17 (depends on 1)

The IMD in accordance with claim 1, wherein the electrically insulated further portion of the outer surface is formed due a polymer-based coating applied to the further portion of the outer surface.

### Claim 18 (depends on 17)

The IMD in accordance with claim 17, wherein the polymer-based coating is at least one of a Parylene C coating and a silicone polymer-based coating.

### Claim 19 (depends on 18)

The IMD in accordance with claim 18, wherein the silicone polymer-based coating is applied over the Parylene C coating on the further portion of the outer surface.
