# US 12,599,786 B2 · Ultrasound device with attachable components

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- Number: US 12,599,786 B2
- Document ID: US12599786B2
- Status: Granted
- Kind: B2
- Application number: 17/628,341
- Filed: 2020-07-17
- Published: 2022-08-11
- Granted: 2026-04-14
- Earliest claimed: 2019-07-19
- Assignees: Madorra Inc.
- Applicants: Madorra Inc.
- Inventors: Ryan Taylor Krone; Holly Elizabeth Rockweiler; Lauren Paige Jones; Eric Schultz; Bryan Flaherty
- Web page: https://patentgrep.com/patent/US12599786B2

## CPC

- A61B 90/96: using barcodes
- A61N 7/02: Localised ultrasound hyperthermia
- A61B 8/4411: {Device being modular}
- 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 2090/0803: {Counting the number of times an instrument is used}
- A61B 2090/0814: {Preventing re-use}
- A61B 2562/08: Sensors provided with means for identification, e.g. barcodes or memory chips
- A61B 2562/24: Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
- A61N 2007/0004: {Applications of ultrasound therapy}
- A61N 2007/0073: {using multiple frequencies}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

A handheld ultrasound device and corresponding methods, including devices and methods used for rejuvenating the vulvovaginal area of the user. In general, the handheld ultrasound devices include a device body coupled to an acoustic coupler and a handle. The device body further includes internal components including an ultrasound transducer, an energy delivery element, and circuitry for controlling the ultrasound output. In particular examples, the methods of using the handheld ultrasound device include engaging the tissue in and around the vulvovaginal area with the energy delivery element, applying ultrasound energy to the vulvovaginal tissue from the energy delivery element and through the acoustic coupler, and affecting a measurable parameter associated with vulvovaginal rejuvenation.

## Claims

### Claim 1

A device for applying ultrasonic energy to a subject, comprising:
a plurality of disposable components adapted to contact tissue of the subject comprising a plurality of optically readable codes, wherein the plurality of optically readable codes includes encoded identification information associated with the disposable component; and
a reusable component comprising an ultrasound transducer assembly and a code reader assembly adapted to detect the plurality of optically readable codes of the plurality of disposable components, wherein the reusable component is adapted to verify that a one of the plurality of disposable components corresponds to a pre-approved disposable component, that the one of the plurality of disposable components is unused, or that the one of the plurality of disposable components corresponds to a pre-approved disposable component and is unused,
wherein when the reusable component and the one of the plurality of disposable components are attached together, the ultrasound transducer assembly and the one of the plurality of disposable components are adapted to deliver ultrasound energy to the subject based on parameters for prescribed therapeutic treatments stored in the plurality of optically readable codes, wherein the parameters for the prescribed therapeutic treatment stored in the plurality of optically readable codes include therapy duration, lockout duration, ultrasound frequency, duty cycle, and intensity of the ultrasonic energy; wherein the one of plurality of disposable components having the one of the plurality of optically readable codes is configured to be swappable with another one of the plurality of disposable components having a different one of the plurality of optically readable codes to change the prescribed therapeutic treatment.

### Claim 2 (depends on 1)

The device of claim 1, wherein the reusable component and the plurality of disposable components are adapted to deliver the ultrasound energy for imaging internal body structures of the subject.

### Claim 3 (depends on 1)

The device of claim 1, wherein the reusable component and the plurality of disposable components are adapted to deliver a therapeutic ultrasound energy to one or more tissues of the subject including vaginal tissue of the subject.

### Claim 4 (depends on 1)

The device of claim 1, wherein the reusable component and the plurality of disposable components are adapted to deliver a therapeutic ultrasound energy to the subject's genital tissue.

### Claim 5 (depends on 1)

The device of claim 1, wherein the disposable component includes a coupling pad adapted to contact external genital tissue around the subject's vagina.

### Claim 6 (depends on 1)

The device of claim 1, wherein the code reader assembly is adapted to emit light to illuminate the optically readable code.

### Claim 7 (depends on 1)

The device of claim 1, wherein the optical reader assembly operates at a focal distance ranging from about 1 millimeter (mm) to about 12 mm.

### Claim 8 (depends on 1)

The device of claim 1, wherein the plurality of disposable components include a coupling pad comprising a gel.

### Claim 9 (depends on 1)

The device of claim 1, wherein a housing of the reusable component includes a window through which the code reader assembly transmits and receives light.

### Claim 10 (depends on 9)

The device of claim 9, wherein the window is on a head portion of the reusable component, the head portion including a transducer head of the ultrasound transducer assembly.

### Claim 11 (depends on 10)

The device of claim 10, wherein the window is on a transducer face of the head portion, wherein the transducer face is adapted to contact a support of the one of the plurality of disposable components when the one of the plurality of disposable components is properly attached to the reusable component.

### Claim 12 (depends on 1)

The device of claim 1, wherein the device is configured to provide feedback to a user indicating that the one of the plurality of disposable components is properly attached to the reusable component.

### Claim 13

A method of applying ultrasonic energy to a subject, the method comprising:
verifying a one of a plurality of optically readable codes on one of a plurality of disposable components using an optical reader assembly of an ultrasound device, wherein the verifying includes determining that the one of the plurality of disposable components corresponds to a pre-approved disposable component, that the one of the plurality of disposable components is unused, or that the one of the plurality of disposable components corresponds to a pre-approved disposable component and is unused;
delivering the ultrasonic energy to the subject based on parameters for prescribed therapeutic treatment stored in the one of the plurality of optically readable codes using the ultrasonic device with the one of the plurality of disposable components attached thereto contacting tissue of the subject, wherein delivering the ultrasonic energy to the subject based on the parameters for the prescribed therapeutic treatment stored in the one of the plurality of optically readable codes includes delivering the ultrasonic energy based on parameters stored in the one of the plurality of optically readable codes for therapy duration, lockout duration, ultrasound frequency, duty cycle, and intensity of the ultrasonic energy; and
changing the prescribed therapeutic treatment by swapping the one of the plurality of disposable components having the one of the plurality of optically readable codes with another one of the plurality of disposable components having another one of the plurality of optically readable codes.

### Claim 14 (depends on 13)

The method of claim 13, wherein the ultrasonic energy is adapted to deliver a therapeutic dose of ultrasonic energy to one or more tissues of the subject including vaginal tissue of the subject.

### Claim 15 (depends on 14)

The method of claim 14, wherein delivering the therapeutic dose of ultrasonic energy increases blood flow to internal vaginal tissue up to 300% above a baseline level of blood flow to the internal vaginal tissue such that the increased level of blood flow to the internal vaginal tissue persists after delivery of therapeutic ultrasonic energy ceases.

### Claim 16 (depends on 15)

The method of claim 15, wherein the plurality of disposable components includes a coupling pad comprising a deformable coupling structure adapted to contact external genital tissue around the subject's vagina.

### Claim 17 (depends on 13)

The method of claim 13, further comprising determining that the one of the plurality of disposable components is properly attached to the ultrasound device prior to delivering the ultrasonic energy to the subject.

### Claim 18 (depends on 17)

The method of claim 17, wherein the determining includes verifying sufficient contact between the disposable component and the ultrasound device.

### Claim 19 (depends on 17)

The method of claim 17, wherein the determining includes detecting attachment of the disposable component to the ultrasound device using one or more magnetoresistive sensors.
