# US 11,439,812 B2 · Array operative to perform distributed/patterned sensing and/or stimulation across patient bodily section

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- Number: US 11,439,812 B2
- Document ID: US11439812B2
- Status: Granted
- Kind: B2
- Application number: 16/891,591
- Filed: 2020-06-03
- Published: 2021-12-09
- Granted: 2022-09-13
- Earliest claimed: 2020-06-03
- Assignees: Sigmasense, LLC.
- Applicants: Sigmasense, LLC.
- Inventors: John Christopher Price; Shayne X. Short; Timothy W. Markison
- Web page: https://patentgrep.com/patent/US11439812B2

## CPC

- A61N 1/0484: {Garment electrodes worn by the patient}
- A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium}
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/363: Detecting tachycardia or bradycardia
- A61B 5/4519: {Muscles (measuring muscular strength A61B5/224; using electromyography [EMG] A61B5/389)}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61N 1/3622: {comprising two or more electrodes co-operating with different heart regions}
- A61N 1/36507: {controlled by gradient or slope of the heart potential}
- A61N 1/3706: {Pacemaker parameters (stimulation threshold A61N1/371)}
- A61N 1/3712: {Auto-capture, i.e. automatic adjustment of the stimulation threshold}
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 2562/0209: Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
- A61B 2562/046: in a matrix array
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An electrical stimulation system includes a sheath that includes conductive points that are operative to facilitate electrical stimulation to a bodily portion of a user. Drive-sense circuits (DSCs) generate electrical stimulation signals based on reference signals and provide those electrical stimulation signals via electrodes to the conductive points of the sheath. The electrical stimulation signal is coupled into respective locations of the bodily portion of the user that are in proximity to or in contact with the conductive points of the sheath. In addition, the DSCs sense, via the conductive points of the sheath and via the electrodes, changes of the electrical stimulation signals based on coupling of them into the respective locations of the bodily portion of the user. The DSCs provide digital signals that are representative of the changes of the electrical stimulation signals to one or more processing modules that includes and/or is coupled to memory.

## Claims

### Claim 1

An electrical stimulation system comprising:
a sheath that includes a plurality of conductive points that are operative to facilitate electrical stimulation to a bodily portion of a user;
a plurality of drive-sense circuits (DSCs) operably coupled to the plurality of conductive points of the sheath via a plurality of electrodes, wherein the plurality of DSCs are configured to generate a plurality of electrical stimulation signals based on a plurality of reference signals, wherein the plurality of electrical stimulation signals are coupled into the bodily portion of the user via the plurality of conductive points of the sheath, wherein:
when enabled, a first DSC of the plurality of DSCs configured to:
provide a first electrical stimulation signal via a first electrode to a first conductive point of the sheath, wherein the first electrical stimulation signal is coupled into a first location of the bodily portion of the user that is in proximity to or in contact with the first conductive point of the sheath;
sense, via the first conductive point of the sheath and via the first electrode, a first change of the first electrical stimulation signal based on coupling of the first electrical stimulation signal into the first location of the bodily portion of the user; and
generate a first digital signal that is representative of the first change of the first electrical stimulation signal;
when enabled, a second DSC of the plurality of DSCs configured to:
provide a second electrical stimulation signal via a second electrode to a second conductive point of the sheath, wherein the second electrical stimulation signal is coupled into a second location of the bodily portion of the user that is in proximity to or in contact with the second conductive point of the sheath;
sense, the second conductive point of the sheath and via the second electrode, a second change of the second electrical stimulation signal based on coupling of the second electrical stimulation signal into the second location of the bodily portion of the user; and
generate a second digital signal that is representative of the second change of the second electrical stimulation signal;
memory that stores operational instructions; and
one or more processing modules operably coupled to the plurality of DSCs and the memory, wherein, when enabled, the one or more processing modules is configured to execute the operational instructions to:
generate the plurality of reference signals; and
process a plurality of digital signals generated by the plurality of DSCs including the first digital signal generated by the first DSC and the second digital signal generated by the first DSC to determine a response profile of one or more electrical characteristics of the bodily portion of the user.

### Claim 2 (depends on 1)

The electrical stimulation system of claim 1, wherein the sheath is implemented with a rigid material that is shaped to interface with the bodily portion of the user.

### Claim 3 (depends on 1)

The electrical stimulation system of claim 1, wherein the sheath is implemented with a flexible and wrap-able material that is operative to be placed against the bodily portion of the user, wherein the sheath includes one or more fasteners to keep sheath in place against the bodily portion of the user.

### Claim 4 (depends on 1)

The electrical stimulation system of claim 1, wherein the first electrical stimulation signal is 180 degrees out of phase to the second electrical stimulation signal, and the first conductive point of the sheath and the second conductive point of the sheath operate cooperatively to provide differential electrical stimulation between the first location of the bodily portion of the user and the second location of the bodily portion of the user.

### Claim 5 (depends on 1)

The electrical stimulation system of claim 1, wherein the plurality of electrodes are electrically isolated from each other within the sheath by an electrically insulating material.

### Claim 6 (depends on 1)

The electrical stimulation system of claim 1, wherein the bodily portion of the user is a leg, an arm, abdomen, chest or thorax, or head of the user.

### Claim 7 (depends on 1)

The electrical stimulation system of claim 1, wherein the plurality of conductive points of the sheath are arranged in a matrix pattern including rows of conductive points and columns of conductive points.

### Claim 8 (depends on 7)

The electrical stimulation system of claim 7, wherein, when enabled, the plurality of DSCs is configured to:
provide the plurality of electrical stimulation signals via the plurality of electrodes to the plurality of conductive points, including the first electrical stimulation signal via the first electrode to the first conductive point of the sheath and the second electrical stimulation signal via the second electrode to the second conductive point of the sheath, such that electrical stimulation is provided sequentially and successively via the rows of conductive points or via the columns of conductive points such that a first row or first column of the conductive points provide electrical stimulation at or during a first time and a second row or second column of the conductive points provide electrical stimulation at or during a second time that follows the first time.

### Claim 9 (depends on 1)

The electrical stimulation system of claim 1, wherein the first DSC further comprises:
a power source circuit operably coupled via a single line to the first electrode that couples to the first conductive point, wherein, when enabled, the power source circuit is configured to provide an analog signal via the single line coupling to the first electrode that couples to the first conductive point, and wherein the analog signal includes at least one of a DC (direct current) component or an oscillating component; and
a power source change detection circuit operably coupled to the power source circuit, wherein, when enabled, the power source change detection circuit is configured to:
detect an effect on the analog signal that is based on coupling of the first electrical stimulation signal into the first location of the bodily portion of the user; and
generate the first digital signal that is representative of the first change of the first electrical stimulation signal.

### Claim 10 (depends on 9)

The electrical stimulation system of claim 9 further comprising:
the power source circuit including a power source to source at least one of a voltage or a current via the single line to the first electrode that couples to the first conductive point; and
the power source change detection circuit including:
a power source reference circuit configured to provide at least one of a voltage reference or a current reference; and
a comparator configured to compare the at least one of the voltage or the current provided via the single line to the first electrode that couples to the first conductive point to the at least one of the voltage reference or the current reference to produce the analog signal.

### Claim 11

An electrical stimulation system comprising:
a sheath that includes a plurality of conductive points that are operative to facilitate electrical stimulation to a bodily portion of a user;
a plurality of drive-sense circuits (DSCs) operably coupled to the plurality of conductive points of the sheath via a plurality of electrodes, wherein the plurality of DSCs are configured to generate a plurality of electrical stimulation signals based on a plurality of reference signals, wherein the plurality of electrical stimulation signals are coupled into the bodily portion of the user via the plurality of conductive points of the sheath, wherein:
when enabled, a DSC of the plurality of DSCs configured to:
provide an electrical stimulation signal via an electrode to a conductive point of the sheath, wherein the electrical stimulation signal is coupled into a location of the bodily portion of the user that is in proximity to or in contact with the conductive point of the sheath;
sense, via the conductive point of the sheath and via the electrode, a change of the electrical stimulation signal based on coupling of the electrical stimulation signal into the location of the bodily portion of the user; and
generate a digital signal that is representative of the change of the electrical stimulation signal; and
when enabled, the plurality of DSCs is configured to provide the plurality of electrical stimulation signals via the plurality of electrodes to the plurality of conductive points sequentially and successively via respective subsets of the plurality of conductive points that each include fewer than all of the plurality of conductive points such that a first subset of the plurality of conductive points provide electrical stimulation at or during a first time and a second subset of the plurality of conductive points provide electrical stimulation at or during a second time that follows the first time;
memory that stores operational instructions; and
one or more processing modules operably coupled to the plurality of DSCs and the memory, wherein, when enabled, the one or more processing modules is configured to execute the operational instructions to:
generate the plurality of reference signals; and
process a plurality of digital signals generated by the plurality of DSCs including the digital signal generated by the DSC to determine a response profile of one or more electrical characteristics of the bodily portion of the user.

### Claim 12 (depends on 11)

The electrical stimulation system of claim 11, wherein the sheath is implemented with a rigid material that is shaped to interface with the bodily portion of the user.

### Claim 13 (depends on 11)

The electrical stimulation system of claim 11, wherein the sheath is implemented with a flexible and wrap-able material that is operative to be placed against the bodily portion of the user, wherein the sheath includes one or more fasteners to keep sheath in place against the bodily portion of the user.

### Claim 14 (depends on 11)

The electrical stimulation system of claim 11, when enabled, another DSC of the plurality of DSCs configured to:
provide another electrical stimulation signal via another electrode to another conductive point of the sheath, wherein the another electrical stimulation signal is coupled into another location of the bodily portion of the user that is in proximity to or in contact with the another conductive point of the sheath;
sense, via the another conductive point of the sheath and via the another electrode, another change of the another electrical stimulation signal based on coupling of the another electrical stimulation signal into the another location of the bodily portion of the user; and
generate another digital signal that is representative of the another change of the another electrical stimulation signal.

### Claim 15 (depends on 14)

The electrical stimulation system of claim 14, wherein the electrical stimulation signal is 180 degrees out of phase to the another electrical stimulation signal, and the conductive point of the sheath and the another conductive point of the sheath operate cooperatively to provide differential electrical stimulation between the location of the bodily portion of the user and the another location of the bodily portion of the user.

### Claim 16 (depends on 11)

The electrical stimulation system of claim 11, wherein the plurality of electrodes are electrically isolated from each other within the sheath by an electrically insulating material.

### Claim 17 (depends on 11)

The electrical stimulation system of claim 11, wherein the bodily portion of the user is a leg, an arm, abdomen, chest or thorax, or head of the user.

### Claim 18 (depends on 11)

The electrical stimulation system of claim 11, wherein:
the plurality of conductive points of the sheath are arranged in a matrix pattern including rows of conductive points and columns of conductive points;
the first subset of the plurality of conductive points includes a first row of conductive points; and
the second subset of the plurality of conductive points includes a second row of conductive points.

### Claim 19 (depends on 11)

The electrical stimulation system of claim 11, wherein the DSC further comprises:
a power source circuit operably coupled via a single line to the electrode that couples to the conductive point, wherein, when enabled, the power source circuit is configured to provide an analog signal via the single line coupling to the electrode that couples to the conductive point, and wherein the analog signal includes at least one of a DC (direct current) component or an oscillating component; and
a power source change detection circuit operably coupled to the power source circuit, wherein, when enabled, the power source change detection circuit is configured to:
detect an effect on the analog signal that is based on coupling of the electrical stimulation signal into the location of the bodily portion of the user; and
generate the digital signal that is representative of the change of the electrical stimulation signal.

### Claim 20 (depends on 19)

The electrical stimulation system of claim 19 further comprising:
the power source circuit including a power source to source at least one of a voltage or a current via the single line to the electrode that couples to the conductive point; and
the power source change detection circuit including:
a power source reference circuit configured to provide at least one of a voltage reference or a current reference; and
a comparator configured to compare the at least one of the voltage or the current provided via the single line to the electrode that couples to the conductive point to the at least one of the voltage reference or the current reference to produce the analog signal.
