Systems for treating skin laxity

• US 9,427,600 B2
• Filed: 04/21/2015
• Issued: 08/30/2016
• Est. Priority Date: 10/06/2004
• Status: Active Grant

• Current Assignee: Guided Therapy Systems Llc
• Original Assignee: Guided Therapy Systems Llc
• Inventors: Barthe, Peter G., Slayton, Michael H., Makin, Inder Raj S.
• Primary Examiner(s): Peng, Bo J
• Application Number:
  US14/692,114
• Publication Number:
  US 20150224347A1
• Time in Patent Office: 497 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6842 by marking the skin
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/0858 involving measuring tissue layers, e.g. skin, interfaces
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/13 Tomography A61B8/10, A61B8/12 take precedence; tomography for radiation diagnosis A61B6/02
• CPC Class Codes: A61B 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4455 Features of the external shape of the probe, e.g. ergonomic aspects
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/483 involving the acquisition of a 3D volume of data
• CPC Class Codes: A61B 8/546 involving monitoring or regulation of device temperature
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 23/0245 with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 2007/0034 Skin treatment
• CPC Class Codes: A61N 2007/0052 using the same transducer for therapy and imaging
• CPC Class Codes: A61N 2007/027 with multiple foci created simultaneously
• CPC Class Codes: 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
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: G01S 15/8909 : using a static transducer configuration

Abstract

A system and method for ultrasound treatment of skin laxity are provided. Systems and methods 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. In an embodiment, a treatment system and method 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

1. An ultrasound system for treatment of skin laxity, the system comprising:

an ultrasound probe comprising a housing, wherein the housing comprises a motion mechanism and an ultrasound transducer,

wherein the ultrasound transducer comprises a therapy component and an imaging component,

wherein the therapy component consists of;

a single active spherically-focused ultrasound therapy element,

wherein the ultrasound therapy element is configured to provide a single mechanical focus,

wherein the single mechanical focus is configured to provide ultrasound therapy energy in the form of a single thermal focus in a tissue at a depth below a skin surface,

wherein the depth is a single, fixed depth in a range of up to 5 mm below the skin surface to treat the tissue,

wherein the tissue comprises a combination of any of the group consisting of;

an epidermal tissue, a superficial dermal tissue, a mid-dermal tissue, a deep dermal tissue, a muscle tissue, and an adipose tissue,

wherein the single thermal focus is formed without electronic focusing and without a lens,

wherein the imaging component comprises an ultrasound imaging element,

wherein the ultrasound imaging element is configured for imaging a region of interest under the skin surface, wherein the region of interest comprises the tissue,

wherein a portion of the ultrasound probe is configured for acoustic coupling to a skin surface;

a control system connected to the motion mechanism and the ultrasound therapy element;

a display configured to display an image of the region of interest;

an input device connected to the control system; and

a power supply connected to the control system;

wherein the ultrasound imaging element is connected to the display and the control system,

wherein the ultrasound therapy element is configured for delivery of energy at a temperature sufficient to shrink at least a portion of the tissue at the depth under the skin surface,

wherein the ultrasound therapy element is connected to the motion mechanism,

wherein the motion mechanism moves the ultrasound therapy element to form a plurality of thermal lesions at the depth for shrinking at least a portion of the tissue for reducing the appearance of skin laxity.

2. The system of claim 1, wherein the imaging element is configured for imaging at a frequency range of 2 MHz to 75 MHz,

wherein the imaging component and the therapy component are co-housed within the ultrasound probe,

wherein the ultrasound therapy element is configured to increase the temperature of the tissue in the region of interest to greater than 60°

C.

3. The system of claim 1, further comprising a monitoring system,

wherein the monitoring system is configured to monitor a treatment parameter, wherein the treatment parameter measured comprises a temperature of the tissue below the skin surface,

wherein the housing further comprises a temperature monitoring sensor,

wherein the therapy element is a single element that delivers ultrasound energy at a frequency of between 2 MHz to 25 MHz.

4. The system of claim 1, wherein the housing contains a temperature monitoring sensor,

wherein the control system comprises a processor, software, and a communication device,

wherein the ultrasound probe is connected to the control system via a cable,

wherein the processor relays data from the temperature monitoring sensor via the communication device.

5. The system of claim 1,

wherein the motion mechanism comprises an encoder and the ultrasound energy is configured to deliver an energy level for causing at least one of shrinking collagen and denaturing the tissue in the region of interest under a wrinkle,

wherein the therapy element delivers ultrasound energy at a frequency of between 2 MHz to 25 MHz.

6. The system of claim 1, wherein the control system comprises a spatial control and a temporal control,

wherein the spatial control and the temporal control are configured for controlling the delivery of energy at a temperature sufficient to cause denaturation of at least the portion of the tissue at the depth under the skin surface,

wherein the spatial control and the temporal control are configured for controlling the delivery of energy at a frequency of between 2 MHz to 25 MHz.

7. An ultrasound system for treatment of skin laxity, the system comprising:

an ultrasound probe configured for delivery of an ultrasound energy at a temperature sufficient to heat at least a portion of a tissue at a depth under a skin surface,

wherein the tissue comprises a combination of any of the group consisting of;

an epidermal tissue, a superficial dermal tissue, a mid-dermal tissue, a deep dermal tissue, a muscle tissue, and an adipose tissue; and

a control system;

wherein the ultrasound probe comprises a housing, wherein the housing comprises a motion mechanism and an ultrasound transducer,

wherein the ultrasound transducer comprises a therapy component and an imaging component,

wherein the therapy component consists of;

a single active ultrasound therapy element,

wherein the single active ultrasound therapy element is configured to provide a single, spherically-focused mechanical focus,

wherein the single, spherically-focused mechanical focus is configured to provide ultrasound therapy energy in the form of a single thermal focus in the tissue at a depth below a skin surface,

wherein the single thermal focus is formed without electronic focusing and without a lens,

wherein the imaging component comprises an ultrasound imaging element,

wherein the ultrasound therapy element is in communication with the control system,

wherein the motion mechanism is in communication with the control system,

wherein the ultrasound therapy element is configured for delivery of the ultrasound energy at the temperature sufficient to heat the at least a portion of the tissue at the depth under the skin surface,

wherein the ultrasound therapy element is connected to a portion of the motion mechanism,

wherein the motion mechanism moves the ultrasound therapy element to form a plurality of thermal lesions at the depth for reducing the appearance of skin laxity.

8. The system of claim 7,

wherein the ultrasound imaging element is configured for imaging a region of interest under the skin surface, wherein the region of interest comprises the tissue, wherein the skin surface comprises a wrinkle.

9. The system of claim 7, further comprising a monitoring system,

wherein the monitoring system is configured to monitor a treatment parameter, wherein the treatment parameter measured comprises a temperature of the tissue below the skin surface,

wherein the housing further comprises a temperature monitoring sensor,

wherein the ultrasound therapy element delivers ultrasound energy at a frequency of between 2 MHz to 75 MHz.

10. The system of claim 7, wherein the ultrasound probe is connected to the control system via a cable, and wherein the control system comprises:

a communication device;

a motion mechanism control;

a processor, software, an input device, and a power supply.

11. The system of claim 7,

wherein the ultrasound therapy element is a single element that delivers ultrasound energy at a frequency of between 2 MHz to 25 MHz,

wherein the ultrasound therapy element is configured to increase the temperature of the tissue in the region of interest to greater than 60°

C.

12. An ultrasound system for treatment of skin laxity, the system comprising:

an ultrasound probe comprising a housing, wherein the housing comprises a motion mechanism and an ultrasound transducer,

wherein the ultrasound transducer comprises a therapy component and an imaging component,

wherein the therapy component consists of;

a single active spherically-focused ultrasound therapy element,

wherein the ultrasound therapy element is configured to provide a single mechanical focus,

wherein the single mechanical focus is configured to provide ultrasound therapy energy in the form of a single thermal focus in a tissue at a depth below a skin surface,

wherein the depth is up to 5 mm below the skin surface,

wherein the tissue comprises a combination of any of the group consisting of;

an epidermal tissue, a superficial dermal tissue, a mid-dermal tissue, a deep dermal tissue, an adipose tissue, and a muscle tissue,

wherein the single thermal focus is formed without electronic focusing and without a lens,

wherein the imaging component comprises an ultrasound imaging element,

a control system comprising a processor and power supply; and

a display,

wherein the ultrasound imaging element is in communication with the display,

wherein the ultrasound imaging element is configured for imaging the tissue,

wherein the display is configured to display an image of the tissue,

wherein the ultrasound therapy element is in communication with the control system,

wherein the ultrasound therapy element is configured for delivery of energy at a temperature sufficient to denature at least a portion of the tissue in the region of interest at a depth under the skin surface,

wherein the ultrasound therapy element is connected to a portion of the motion mechanism,

wherein the motion mechanism is in communication with the control system,

wherein the motion mechanism moves the ultrasound therapy element to form a plurality of thermal lesions at the depth for reducing skin laxity.

13. The system of claim 12,

wherein the motion mechanism comprises an encoder, wherein the ultrasound probe is connected to the control system via a cable,

wherein the imaging component and the ultrasound therapy component are co-housed within the ultrasound probe,

wherein the skin surface comprises a wrinkle.

14. The system of claim 12, further comprising an acoustic coupler between the ultrasound probe and the skin surface,

wherein the therapy element is a single element that delivers ultrasound energy at a frequency of between 2 MHz to 25 MHz,

wherein the housing further comprises a temperature monitoring sensor.

15. The system of claim 12,

wherein the ultrasound imaging element and the ultrasound therapy element are in a combined transducer,

wherein the ultrasound therapy element is configured to increase the temperature of the tissue in the region of interest to greater than 60°

C.

16. The system of claim 12,

wherein the ultrasound imaging element is separate from, and co-housed with, the ultrasound therapy element in the probe.

17. The system of claim 12, further comprising a monitoring system,

wherein the monitoring system is configured to monitor a treatment parameter, wherein the treatment parameter measured comprises a temperature of the tissue below the skin surface,

wherein the housing further comprises a temperature monitoring sensor.

18. The system of claim 12,

wherein the motion mechanism is a linear motion mechanism for linear movement of the ultrasound therapy element to form a plurality of thermal lesions along a line at the depth in the region of interest.

19. The system of claim 12,

wherein the motion mechanism is configured for any one of the group consisting of linear, rotational, and variable movement of the ultrasound therapy element.

20. The system of claim 12,

wherein the motion mechanism comprises an encoder for monitoring a position of the ultrasound therapy element on the motion mechanism in a housing of the probe,

wherein the therapy element is a single element that delivers ultrasound energy at a frequency of between 2 MHz to 25 MHz,

wherein the ultrasound therapy element is configured to deliver the energy at the depth below the skin surface.