# US 9,039,619 B2 · Methods for treating skin laxity

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- Number: US 9,039,619 B2
- Document ID: US9039619B2
- Status: Granted
- Kind: B2
- Application number: 14/169,709
- Filed: 2014-01-31
- Published: 2014-05-29
- Granted: 2015-05-26
- Earliest claimed: 2004-10-07
- Assignees: Guided Therapy Systems, LLC
- Applicants: Guided Therapy Systems, L.L.C.
- Inventors: Peter G. Barthe; Michael H. Slayton; Inder Raj S. Makin
- Web page: https://patentgrep.com/patent/US9039619B2

## CPC

- A61N 7/02: Localised ultrasound hyperthermia
- A61B 5/682: {Mouth, e.g., oral cavity; tongue; Lips; Teeth}
- A61B 5/6842: {by marking the skin}
- A61B 8/08: Clinical applications (A61B8/02, A61B8/04, A61B8/06 take precedence)
- A61B 8/0858: {involving measuring tissue layers, e.g. skin, interfaces}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/13: Tomography (A61B8/10, A61B8/12 take precedence)
- A61B 8/4483: {characterised by features of the ultrasound transducer}
- A61B 8/461: {Displaying means of special interest}
- A61B 8/483: {involving the acquisition of a 3D volume of data}
- A61B 8/546: {involving monitoring or regulation of device temperature}
- A61H 23/0245: {with ultrasonic transducers, e.g. piezoelectric}
- 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})
- G01S 15/8909: {using a static transducer configuration}
- A61B 8/4209: {by using holders, e.g. positioning frames}
- A61B 8/4281: {characterised by sound-transmitting media or devices for coupling the transducer to the tissue}
- A61B 8/4455: {Features of the external shape of the probe, e.g. ergonomic aspects}
- A61B 2017/320069: {for ablating tissue}
- A61H 2201/5007: computer controlled
- A61N 2007/0008: {Destruction of fat cells}
- A61N 2007/0034: {Skin treatment}
- A61N 2007/0052: {using the same transducer for therapy and imaging}
- A61N 2007/027: {with multiple foci created simultaneously}
- 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)
- G01S: RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES

## Abstract

A method and system for ultrasound treatment of skin laxity are provided. Methods and systems can include ultrasound imaging of the region of interest for localization of the treatment area, delivering ultrasound energy at a depth and pattern to achieve the desired therapeutic effects, and/or monitoring the treatment area to assess the results and/or provide feedback. The exemplary treatment method and system can be configured for producing arrays of sub-millimeter and larger zones of thermal ablation to treat the epidermal, superficial dermal, mid-dermal and deep dermal components of tissue.

## Claims

### Claim 1

A method of treating skin laxity, comprising:
imaging a treatment area under a skin surface, the treatment area comprising a combination of a muscle tissue and any one or more of the group consisting of: an epidermal tissue, a superficial dermal tissue, a mid-dermal tissue, a deep dermal tissue, and an adipose tissue;
delivering ultrasound energy with an ultrasound transducer through the skin surface to cause thermal lesions to the treatment area; and
using a motion mechanism to move the ultrasound transducer within a probe to form a plurality of thermal foci to create the lesions along a line in the treatment area
wherein the ultrasound transducer is coupled to the motion mechanism within the probe,
thereby treating skin laxity in the skin surface.

### Claim 2 (depends on 1)

The method according to claim 1,
wherein the motion mechanism comprises an encoder and control system, and
wherein the ultrasound energy is delivered in a frequency range of 2 MHz to 25 MHz and at an energy level sufficient to raise a temperature of a portion of the treatment area to greater than 60° C.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the ultrasound energy is delivered at an energy level sufficient for causing at least one of shrinkage or denaturation of tissue in a portion of the treatment area.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the imaging of the treatment area comprises imaging with an imaging transducer within the probe.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the imaging transducer and the ultrasound transducer are co-housed within the probe.

### Claim 6 (depends on 1)

The method according to claim 1,
wherein the imaging of the treatment area comprises imaging in a frequency range of 2 MHz to 75 MHz with an imaging transducer,
wherein the combination in the treatment area comprises the muscle tissue, the deep dermal tissue, and the adipose tissue,
wherein the imaging transducer and the ultrasound transducer are co-housed within the probe,
wherein the step of delivering ultrasound energy with the ultrasound transducer comprises creating the thermal lesions in at least the muscle tissue, the deep dermal tissue, and the adipose tissue,
wherein the ultrasound energy is delivered in a frequency range of 2 MHz to 25 MHz, and
wherein the ultrasound energy is delivered at an energy level sufficient to raise a temperature in a portion of at least one of the muscle tissue, the deep dermal tissue, and the adipose tissue to greater than 60° C.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the ultrasound energy is delivered at an energy level sufficient to raise a temperature of a portion of the treatment area to greater than 60° C.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the imaging of the treatment area comprises imaging in a frequency range of 2 MHz to 75 MHz with an imaging transducer, wherein the imaging transducer and the ultrasound transducer are co-housed within the probe.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the ultrasound energy is delivered to a depth of 5 mm below the skin surface.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the treatment area comprises a combination of the adipose tissue and the muscle tissue.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the treatment area comprises a combination of the deep dermal tissue and the adipose tissue.

### Claim 12

A method of delivering ultrasound energy for reducing laxity in skin, comprising:
imaging a treatment area under a skin surface, the treatment area comprising a combination of a muscle tissue and any one or more of the group consisting of: an epidermal tissue, a superficial dermal tissue, a mid-dermal tissue, a deep dermal tissue, and an adipose tissue;
delivering ultrasound energy from an ultrasound source to a first target in the treatment area to create a thermal lesion;
moving the ultrasound source with a motion mechanism,
delivering ultrasound energy from the ultrasound source to a second target in the treatment area to create a second thermal lesion, thereby creating a plurality of thermal lesions below the skin surface,
thereby shrinking a volume of tissue comprising the first target and the second target in the treatment area to rejuvenate the laxity in the skin surface.

### Claim 13 (depends on 12)

The method according to claim 12,
wherein the imaging of the treatment area comprises imaging, with an imaging transducer in a frequency range of 2 MHz to 75 MHz,
wherein the ultrasound source is a therapy transducer; and
wherein the therapy transducer and the imaging transducer are co-housed within a single ultrasound probe.

### Claim 14 (depends on 12)

The method according to claim 12,
wherein the imam of the treatment area comprises imaging in a frequency range of 2 MHz to 75 MHz,
wherein the step of delivering ultrasound energy to the first target further comprises causing at least one of shrinkage or denaturation of a portion of the treatment area,
wherein the ultrasound source is a transducer that comprises both a therapy transducer and an imaging transducer.

### Claim 15 (depends on 12)

The method according to claim 12,
wherein the imam of the treatment area comprises imaging in a frequency range of 2 MHz to 75 MHz,
wherein the step of delivering ultrasound energy to the first target is at an energy level sufficient to raise a temperature of a portion of any of the adipose tissue and the muscle tissue to greater than 60° C., and
wherein the delivering ultrasound energy further comprises ablating a portion of the treatment area, wherein the combination in the treatment area comprises the adipose tissue and the muscle tissue.

### Claim 16 (depends on 12)

The method according to claim 12, wherein the treatment area comprises a combination of the deep dermal tissue and the muscle tissue.

### Claim 17 (depends on 12)

The method according to claim 12, wherein the treatment area comprises a combination of the deep dermal tissue and the adipose tissue.

### Claim 18

A method for non-invasive treatment for skin laxity, the method comprising:
providing an ultrasound system comprising an ultrasound probe, a therapy transducer in the probe, and an imaging transducer, the ultrasound system configured for:
(i) imaging, with the imaging transducer, a region of interest under a skin surface, wherein the region of interest comprises an adipose tissue and a muscle tissue;
(ii) treating, with the therapy transducer, skin laxity in the skin surface, wherein the therapy transducer is configured to deliver ultrasound energy to cause thermal lesions in at least the adipose tissue and the muscle tissue in the region of interest; and
(iii) moving the therapy transducer, with a motion mechanism, to form a plurality of the thermal lesions in at least the adipose tissue and the muscle tissue in the region of interest to reduce skin laxity in the skin surface.

### Claim 19 (depends on 18)

The method according to claim 18,
wherein the motion mechanism comprises an encoder and control system, and
wherein the ultrasound energy is delivered in a frequency range of 2 MHz to 25 MHz and at an energy level sufficient to raise a temperature of a portion of the treatment area to greater than 60° C.

### Claim 20 (depends on 18)

The method according to claim 18,
wherein the ultrasound energy is delivered at an energy level sufficient for causing at least one of shrinkage or denaturation of tissue in a portion of the treatment area.

### Claim 21 (depends on 18)

The method according to claim 18, wherein the imaging transducer and the therapy transducer are co-housed within the ultrasound probe.

### Claim 22 (depends on 18)

The method according to claim 18,
wherein the imaging is at a frequency range of 2 MHz to 75 MHz,
wherein the imaging transducer and the therapy transducer are co-housed within the ultrasound probe,
wherein the ultrasound energy is delivered in a frequency range of 2 MHz to 25 MHz, and
wherein the ultrasound energy is delivered at an energy level sufficient to raise a temperature of the treatment region to greater than 60° C.

### Claim 23 (depends on 18)

The method according to claim 18,
wherein the ultrasound energy is delivered at an energy level sufficient to raise a temperature of the treatment area to greater than 60° C.,
wherein the ultrasound energy is delivered to a depth of 5 mm below the skin surface.

### Claim 24 (depends on 18)

The method according to claim 18,
wherein the ultrasound energy is delivered at an energy level sufficient to raise a temperature of a portion of any of the adipose tissue and the muscle tissue to greater than 60° C.,
wherein the imaging transducer and the therapy transducer are co-housed within the ultrasound probe.
