# US 12,214,221 B2 · Apparatus and method for ultrasound spinal cord stimulation

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- Number: US 12,214,221 B2
- Document ID: US12214221B2
- Status: Granted
- Kind: B2
- Application number: 16/623,816
- Filed: 2017-06-21
- Published: 2020-04-16
- Granted: 2025-02-04
- Earliest claimed: 2017-06-21
- Assignees: The Hong Kong Polytechnic University
- Applicants: The Hong Kong Polytechnic University
- Inventors: Md. Monzurul Alam; Yongping Zheng
- Web page: https://patentgrep.com/patent/US12214221B2

## CPC

- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61B 8/4494: {characterised by the arrangement of the transducer elements}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 35/12: Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00)
- A61N 2007/0026: {Stimulation of nerve tissue}
- A61N 2007/0078: {with multiple treatment transducers}
- A61N 2007/0095: {by modifying an excitation signal}
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A method for ultrasound stimulation of spinal cord, the method comprising at least two stimulation cycles, each comprising the steps of: a) obtaining a first real-time spinal cord using a first set of ultrasound transducers; b) selecting a pre-determined stimulation area of the spinal cord from the first real-time spinal cord; c) calculating the position and orientation of the selected stimulation area relative to a second set of ultrasound transducers; and d) stimulating the selected stimulation area of the spinal cord at the calculated relative position and orientation using the second set of ultrasound transducers.

## Claims

### Claim 1

An apparatus for ultrasound image guided ultrasound stimulation of spinal cord in a real-time mode, the apparatus comprising:
an imaging module, wherein the imaging module comprises a first set of ultrasound transducers configured to obtain real-time spinal cord images;
an image recognition module, wherein the image recognition module is configured to select a pre-determined stimulation area of the spinal cord from a first real-time spinal cord image of the real-time spinal cord images, and to calculate a position and orientation of the selected stimulation area relative to the first set of ultrasound transducers represented by a first rigid transform matrix;
a stimulating module, wherein the stimulating module comprises atbe second set of ultrasound transducers configured to stimulate the selected stimulation area of the spinal cord at the calculated relative position and orientation subsequent to the selection of the pre-determined stimulation area of the spinal cord from the first real-time spinal cord image; and
a control module, wherein the control module is configured to coordinate the imaging module, the image recognition module and the stimulating module to operate in at least two stimulation cycles, and whereing in each of the at least two stimulation cycles, at the same time of or after ultrasound stimulation is applied to the se;ected stimulation area of the spinal cord by the stimulating module, the following actions are preformed;
the imaging module obtains a second real-time spinal cord image;
the image recognition module recognizes an actual stimulation area of the spinal cord from the second real-time spinal cord image; and
the control module adjusts the recignition module and/or the stimulating module based on the difference between the actua; stimu;ation area and the predetermined stimulation area;
wherein:
the control module further comprises a receiver configured to generate a magnetic field in space;
the imaging module further comprises a first spatial sensor configured to sense the magnetic field;
the stimulating module further comprises a second spatial sensor configured to sense the magnetic field;
the image recognition module is further configured to calculate a position and orientation of the first and second spatial sensors relative to the receiver according to a strength of the magnetic field and a change of magnitude of the magnetic field, to thereby calculate a position and orientation of the first set of ultrasound transducers relative to the second set of ultrasound transducers represented by a second rigid transform matrix; and
the image recognition module is further configured to calculate the position and orientation of the selected stimulation area relative to the second set of ultrasound transducers with the first and second rigid transform matrixes.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the first and/or second sets of ultrasound transducers are arranged in one or two dimensions as a transducer array.

### Claim 3 (depends on 2)

The apparatus of claim 2, wherein the transducer array is flexible.

### Claim 4 (depends on 1)

The apparatus of claim 1, wherein the difference comprises a difference in location, contour and/or size between the actual stimulation area and the pre-determined stimulation area.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the difference comprises an evoked response of a muscle at the actual stimulation area.

### Claim 6 (depends on 1)

The apparatus of claim 1, wherein adjusting the recognition module comprises at least one of (1) optimizing the image recognition algorithm of the recognition module for selecting the pre-determined stimulation area of the spinal cord from the first real-time spinal cord image; and (2) compensating the calculation of the position and orientation of the selected stimulation area relative to the second set of ultrasound transducers.

### Claim 7 (depends on 1)

The apparatus of claim 1, wherein adjusting the stimulating module comprises adjusting at least one of focus point, focus area, intensity and frequency of an ultrasound beam, and duty cycle, repetition rate and duration of the stimulation cycle.

### Claim 8 (depends on 1)

The apparatus of claim 1, further comprising a feedback module, the feedback module is configured to receive a signal representing muscle contraction from muscle innervated from the pre-determined stimulation area of the spinal cord, and the control module adjusts the recognition module and/or the stimulating module based on the signal.

### Claim 9 (depends on 8)

The apparatus of claim 8, wherein the signal comprises at least one of electromyography, sonomyography, mechanomyography, or electroneurography signal.

### Claim 10 (depends on 8)

The apparatus of claim 8, wherein adjusting the recognition module comprises at least one of (1) optimizing the image recognition algorithm of the recognition module for selecting the pre-determined stimulation area of the spinal cord from the first real-time spinal cord image; and (2) compensating the calculation of the position and orientation of the selected stimulation area relative to the second set of ultrasound transducers.

### Claim 11 (depends on 8)

The apparatus of claim 8, wherein adjusting the stimulating module comprises adjusting at least one of focus point, focus area, intensity and frequency of an ultrasound beam, and duty cycle, repetition rate and duration of the stimulation cycle.

### Claim 12 (depends on 1)

The apparatus of claim 1, further comprising a stem cell injection module, the stem cell injection module is configured to inject stem cells in the pre-determined stimulation area of the spinal cord so that ultrasound stimulation can be applied to the stem cells at the pre-determined stimulation area of the spinal cord.

### Claim 13 (depends on 1)

The apparatus of claim 1, further comprising a brain signal receiving module in communication with the control module, the brain signal receiving module receives a brain signal representing an intended motor action and sends it to the control module, the control module determines a stimulation area with reference to an established functional mapping of the spinal cord so that ultrasound stimulation can be applied to the determined stimulation area to induce the intended motor action.

### Claim 14 (depends on 1)

The apparatus of claim 1, wherein the apparatus is in a wearable form such that the first and second sets of ultrasound transducers are located on a skin surface of a patient in use.
