# US 9,302,104 B2 · Devices, systems, and methods for automated optimization of energy delivery

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- Number: US 9,302,104 B2
- Document ID: US9302104B2
- Status: Granted
- Kind: B2
- Application number: 14/532,595
- Filed: 2014-11-04
- Published: 2015-05-07
- Granted: 2016-04-05
- Earliest claimed: 2008-07-02
- Assignees: Niveus Medical, Inc.
- Applicants: Niveus Medical, Inc.
- Inventors: Brian J. Fahey
- Web page: https://patentgrep.com/patent/US9302104B2

## CPC

- A61N 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)}
- A61B 5/296: for electromyography [EMG]
- A61B 5/4523: {Tendons}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/6828: {Leg}
- A61B 5/6841: {by using templates}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61H 39/002: {Using electric currents (electrotherapy A61N1/32)}
- A61N 1/0452: {Specially adapted for transcutaneous muscle stimulation [TMS]}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61N 1/3603: {Control systems}
- A61B 5/4585: {Evaluating the knee}
- A61B 2090/3904: {specially adapted for marking specified tissue}
- A61H 2201/165: Wearable interfaces
- A61H 2201/5005: for controlling frequency distribution, modulation or interference of a driving signal
- A61H 2201/5015: using specific interfaces or standards, e.g. USB, serial, parallel
- A61H 2201/5061: Force sensors
- A61H 2201/5084: Acceleration sensors
- A61H 2201/5092: Optical sensor
- A61H 2201/5097: wireless
- A61H 2205/10: Leg
- A61H 2205/104: Patella
- A61H 2230/045: used as a control parameter for the apparatus
- A61H 2230/655: used as a control parameter for the apparatus
- 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)
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)

## Abstract

Devices, systems, and methods for automated optimization of muscle stimulation energy. In some embodiments the disclosure optimizes stimulation parameters and/or stimulation location.

## Claims

### Claim 1

A method of electrically stimulating muscle, comprising:
applying a first electrical stimulating signal from an energy source to a muscle at a stimulation region;
sensing an electrical signal in a sensing region that is away from the stimulation region when applying the first electrical stimulating signal;
adjusting at least one parameter of the first electrical stimulating signal based on the sensed electrical signal; and
applying a second electrical stimulating signal from the energy source to the muscle, wherein the second electrical stimulating signal comprises the at least one adjusted parameter.

### Claim 2

The method of claim I wherein sensing an electrical signal comprises sensing the first electrical stimulating signal, or a change that occurs in the first electrical stimulating signal between the stimulation region and the sensing region.

### Claim 3 (depends on 1)

The method of claim 1 wherein sensing an electrical signal comprises sensing an electrical signal independent of or multiplexed into the first electrical stimulating signal, or a change that occurs in the independent or multiplexed signal between the stimulation region and the sensing region.

### Claim 4 (depends on 1)

The method of claim 1 wherein the first electrical stimulating energy signal has a general waveform shape and the sensing step comprises sensing an electrical signal with the same general waveform shape.

### Claim 5 (depends on 4)

The method of claim 4 wherein the first waveform is biphasic and the sensing step comprises sensing the biphasic signal.

### Claim 6 (depends on 5)

The method of claim 5 wherein the sensing step comprises sensing a biphasic signal with the same phase distribution and approximately the same pulse width as the first waveform.

### Claim 7 (depends on 1)

The method of claim 1 wherein the method further comprises using a control unit to analyze the peak voltage amplitude of the sensed signal, and wherein adjusting the at least one parameter of the electrical stimulation energy is based on analyzing the peak voltage amplitude of the sensed energy.

### Claim 8 (depends on 1)

The method of claim 1 wherein the applying step comprises applying a first electrical stimulating signal with a first energy intensity, the method further comprising determining if the sensed electrical signal satisfies a threshold for adequate muscle contraction, and if so, the method further comprises delivering muscle stimulation therapy with a stimulating signal that comprises the first energy intensity.

### Claim 9 (depends on 8)

The method of claim 8 wherein if the sensed electrical signal does not satisfy the threshold for adequate muscle contraction, applying the second electrical stimulating signal with an second energy intensity greater than the first energy intensity, and further sensing an electrical signal during the time when the second electrical stimulating signal is applied, and determining if the second electrical stimulating signal satisfies a threshold for adequate muscle contraction.

### Claim 10

A muscle stimulation system, including:
at least one stimulating electrode adapted to apply a stimulating electrical signal to a muscle at a stimulation region;
at least one sensor adapted to sense the stimulating electrical signal or a change in the stimulating electrical signal at a sensing region; and
a control unit adapted to analyze the sensed stimulating electrical signal or a change in the stimulating electrical signal that occurs between the stimulation region and the sensing region.

### Claim 11 (depends on 10)

The system of claim 10 wherein the control unit is adapted to modify at least one parameter of the stimulating electrical signal, deliver a second stimulating electrical signal to the at least one stimulating electrode with the modified parameter, and compare a second sensed stimulating electrical signal with the sensed stimulating electrical signal.

### Claim 12 (depends on 10)

The system of claim 10 wherein the control unit is further adapted to determine which of the second stimulating electrical signal and the stimulating electrical signal results in a more efficient muscle contraction.

### Claim 13 (depends on 12)

The system of claim 12 wherein the control unit is adapted to automatically deliver a muscle stimulation therapy to the muscle with either the second stimulating electrical signal or the stimulating electrical signal depending on which results in a more efficient muscle contraction.

### Claim 14 (depends on 10)

The system of claim 10 wherein the control unit is adapted to analyze the peak voltage amplitude of the sensed stimulating electrical signal.

### Claim 15 (depends on 10)

The system of claim 10 further comprising a stimulation pad comprising the at least one stimulating electrode, and a sensing pad comprising the at least one sensor.

### Claim 16

A method of electrically stimulating muscle comprising:
delivering a first electrical muscle stimulation signal to a muscle region of the patient;
sensing a signal indicative of a state of a tendon coupled to the muscle during the delivering step; and
delivering a second electrical muscle stimulation signal to the muscle region with at least one signal parameter modified based on the sensed signal indicative of the state of the tendon.

### Claim 17 (depends on 16)

The method of claim 16 wherein the sensing step comprises sensing a signal indicative of a change in the state of a tendon coupled to the muscle.

### Claim 18 (depends on 16)

The method of claim 16 wherein the sensing step comprises sensing a signal indicative of a state of tension in the tendon coupled to the muscle.

### Claim 19 (depends on 16)

The method of claim 16 wherein the sensing step comprises performing an ultrasound analysis of the tendon when delivering the first electrical muscle stimulation signal.

### Claim 20 (depends on 16)

The method of claim 16 wherein the sensing step comprises sensing, at a sensing region on the body, an electrical signal that is applied to the body by an external source at a stimulation region on the body.

### Claim 21 (depends on 20)

The method of claim 20 where the signal applied by the external source is applied when the muscle stimulation energy is applied to the stimulation region.

### Claim 22

A system for electrical muscle stimulation, comprising:
a first sensing pad comprising at least one electrical sensor and an anatomical marker adapted to align with a readily identifiable anatomical feature, wherein the anatomical marker allows the stimulation pad to be positioned on a patient's body in a particular location; and
a stimulation pad comprising at least one electrical stimulation electrode,
wherein the first sensing pad further comprises a first alignment marker that corresponds with a second alignment marker on the stimulation pad, wherein the corresponding first and second alignment markers allow a desired positioning of the stimulation pad on the user's body by aligning the first and second markers.

### Claim 23 (depends on 22)

The system of claim 22 wherein the anatomical marker is an aperture.

### Claim 24 (depends on 23)

The system of claim 23 wherein anatomical marker is an aperture adapted to accommodate the patient's knee.

### Claim 25 (depends on 22)

The system of claim 22 wherein the first alignment marker has a first shape and the second alignment marker has a second shape, wherein the first and second shapes are complementary.