External ultrasound lipoplasty

• US 7,955,281 B2
• Filed: 09/07/2006
• Issued: 06/07/2011
• Est. Priority Date: 09/07/2006
• Status: Active Grant

• Current Assignee: Nivasonix LLC
• Original Assignee: Nivasonix LLC
• Inventors: Pedersen, Laust G., Purkait, Bobby
• Primary Examiner(s): Jung; Unsu
• Assistant Examiner(s): FONTENOT, NIGEL RAI
• Application Number:
  US11/518,367
• Publication Number:
  US 20080097253A1
• Time in Patent Office: 1,734 Days
• Field of Search: None
• US Class Current: 601/2
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 8/546 involving monitoring or regulation of device temperature
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 2007/0065 Concave transducers
• CPC Class Codes: A61N 2007/0073 using multiple frequencies
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 2007/0095 by modifying an excitation signal
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

This invention relates to a non-invasive, safer alternative to current lipoplasty procedures. The preferred embodiment of the invention is a multi-channel system that focuses the low mega Hertz ultrasound at user selectable depths, where fat cells are to be emulsified. The system has independent user control of the main emulsifying property, cavitation, and thermal heating, which can independently be used for skin tightening. One part of the system is a handheld transducer, in shape similar to a typical small diagnostic ultrasound transducer. The other part of the system includes a transmitter with internal tracking of procedure time and with a disabling feature.

Claims

1. An external ultrasound lipoplasty (EUL) system comprising a transmitter and a multichannel transducer comprising an electronic focus and operated in a 0.5 MHz to 20 MHz frequency range, wherein the transmitter is configured to multi-zone focus by electronically sweeping the focus of the transducer such that it generates pulses of acoustic energy at different focal lengths at different times within a user or manufacturer selected depth range between about 1 mm and 30 mm during a use by controlling a plurality of attributes selected from the group consisting of an aperture size, a frequency, a transmit voltage, a delay, an apodization, a pulse repetition frequency and a pulse length for each swept depth to not irreversibly affect tissue of a patient beyond the user or manufacturer selected depth range when an acoustic pressure and intensity of said EUL system is high enough to substantially emulsify fat within said selected depth range of the tissue.

2. The system of claim 1, wherein the transducer is a multi-channel transducer with a 0.5D or 1.5D array.

3. The system of claim 1, wherein the transducer has adequate flexibility to emulsify the fat without significant tissue heating above 39°

C.

4. The system of claim 1, wherein the transducer functions as a skin tightening device through local heating of the tissue without emulsifying fat by locally heating the tissue above 39°

C.

5. The system of claim 1, wherein the transmitter is a multi-channel transmitter that has independent control of a Mechanical Index (MI) and a Thermal Index (TI).

6. The system of claim 1, wherein the transducer has a non-volatile memory containing necessary electro-acoustic information to calculate a Mechanical Index (MI) and a Thermal Index (TI).

7. The system of claim 1, wherein each channel of the multi-channel transducer has a transducer element, and wherein the electronic focus is carried out by electronically delaying the transducer element or expanding the aperture of the transducer element.

8. The system of claim 1, wherein the transducer has a temperature monitoring feature and real-time display of transducer face temperature on a face of said system, and wherein said system is disabled when the transducer face temperature exceeds a predetermined value.

9. The system of claim 1, wherein the transducer has a cavitation detection feature based on pulse-echo signals received by the transducer, the pulse-echo signals being derived from cavitation bubbles or an acoustic shadowing effect of said bubbles within said selected depth range of the tissue.

10. The system of claim 1, wherein the transmitter has a system use counter configured to monitor use of the system or disable the system if a certain time and acoustic activity combination quota is exceeded, wherein said time and acoustic activity combination quota can be updated.

11. The system of claim 10, wherein the system use counter is connected to a personal computer interface, wherein said time and acoustic activity combination quota can be updated through communication with the personal computer.

12. The system of claim 11, wherein system information is uploaded from the system use counter to the personal computer.

13. A method for emulsifying subdermal fat of a patient comprising:

selecting a depth range within which to focus acoustic energy between 1 millimeter and 30 millimeters;

topically applying ultrasound through a hand-held high intensity focused ultrasound transducer acoustically coupled to skin via a liquid or gel, said focused ultrasound transducer comprising a transmitter and a multi-channel transducer operated in a 0.5 MHz to 20 MHz frequency range, wherein the transducer comprises an electronic focus; and

by multi-zone focusing, electronically sweeping the focus of the topically applied acoustic energy within the selected depth range to generate pulses of acoustic energy at different focal lengths at different times and so as to not irreversibly affect tissue of the patient beyond the user or manufacturer selected depth range when an acoustic pressure and intensity of said focused ultrasound transducer is high enough to substantially emulsify said subdermal fat within said selected depth range of the tissue.

14. The method of claim 13, wherein said method further comprises applying a medical diagnostic ultrasound system for measuring an amount of emulsified and metabolized fat from said subdermal fat.

15. The method of claim 13, wherein said method further comprises applying a tactile measurement system for verification of emulsified fat.

16. The method of claim 13, wherein said method further comprises applying a self actuated pressure roller device for redistribution of liquefied fat from said subdermal fat and smoothing of the skin.

17. The method of claim 13, wherein said method further comprises applying a chemical solution and introduction method of the solution to area of the subdermal fat for further dissolution of said fat.

18. The method of claim 13, wherein said method further comprises applying a reagent strip/kit for urine monitoring metabolized fat from said subdermal fat.

19. The method of claim 13, wherein said gel is a skin rejuvenation gel or cream.

20. The method of claim 13, wherein the transducer comprises transducer elements and the electronic sweeping the focus to generate pulses of acoustic energy at different focal lengths comprises electronically delaying the transducer elements.

21. The method of claim 13, wherein the transducer comprises transducer elements and the electronic sweeping the focus to generate pulses of acoustic energy at different focal lengths comprises electronically apodizing an aperture of the transducer elements.