Tissue remodeling apparatus containing cooling fluid

• US 6,350,276 B1
• Filed: 06/30/1999
• Issued: 02/26/2002
• Est. Priority Date: 01/05/1996
• Status: Expired due to Term

• Current Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Thermage Incorporated (Bausch Health Cos., Inc.)
• Inventors: Knowlton, Edward W.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/337,015
• Time in Patent Office: 972 Days
• Field of Search: 607/96, 607/101-102, 607/104, 607/108, 606/27, 606/28, 606/29, 606/31-33
• US Class Current: 607/104
• CPC Class Codes: A45D 44/22 Face shaping devices, e.g. chin straps; Wrinkle removers, e.g. stretching the skin skin stretchers for shaving A45D27/38
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/0066 without feedback, i.e. open loop control
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2007/0021 Female breast
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2207/00 Anti-cellulite devices
• CPC Class Codes: A61H 7/001 without substantial movement between the skin and the device
• CPC Class Codes: A61H 9/005 Pneumatic massage
• CPC Class Codes: A61H 9/0071 by localized pressure, e.g. air streams or jets
• CPC Class Codes: A61M 2205/3606 : cooled
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 1/28 : Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/30 : Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2005/0645 : Applicators worn by the patient
• CPC Class Codes: A61N 5/04 : Radiators for near-field treatment
• CPC Class Codes: A61N 5/0616 : Skin treatment other than tanning

Abstract

A fluid delivery apparatus for introducing a fluid cooling media to a skin surface includes a template with a skin interface surface. An energy delivery device is coupled to the template. A fluid cooling media introduction member is coupled to the template. Resources controllably deliver energy from the energy delivery device to the skin surface. In a related embodiment, the resources are configured to controllably deliver the flowable cooling media to the introduction member. In another embodiment, a sensor is coupled to the resources and to the skin surface.

Claims

1. An apparatus for cooling a skin surface during remodeling of a soft tissue structure underneath the skin surface, comprising:

a template comprising a layer that is made of semiconductive material and has a curved skin interface surface that substantially conforms to the general three-dimensional contour of the soft tissue structure;

an energy delivery device coupled to the template;

a flowable cooling media introduction member coupled to the template; and

an energy resource configured to controllably deliver energy from the energy delivery device to the skin surface.

2. The apparatus of claim 1, further comprising a fluid resource configured to controllably deliver the flowable cooling media to the introduction member.

3. The apparatus of claim 2, further comprising:

a sensor coupled to the fluid resource and adapted to be coupled to the skin surface.

4. The apparatus of claim 1, further comprising:

a sensor coupled to the energy resource and adapted to be coupled to the skin surface.

5. The apparatus of claim 4, wherein the sensor is a thermal sensor.

6. The apparatus of claim 1, wherein the energy resource provides a pulsed delivery of energy from the energy delivery device.

7. The apparatus of claim 4, wherein the energy resource includes a feedback control.

8. The apparatus of claim 1, wherein the energy resource provides a controlled delivery of energy to the skin surface that does not exceed 1000 joules/cm2 during a single delivery of energy.

9. The apparatus of claim 1, wherein the energy resource provides a controlled dose rate of energy to the skin surface of no more than 10 joules/sec/cm2.

10. The apparatus of claim 1, wherein the energy resource provides a controlled delivery of electromagnetic energy to a skin surface to operate in an impedance range at the skin surface of 70 ohms cm2 measured at a frequency of 88 Hz to 40 Kohms cm2 measured at a frequency of 10 KHz.

11. The apparatus of claim 1, wherein the energy delivery device produces electromagnetic energy and the energy resource adjusts a frequency of the electromagnetic energy to correspond to a selected temperature at the skin surface.

12. The apparatus of claim 11, wherein the energy resource provides a controlled delivery of electromagnetic energy to operate in a range of thermal conductivity at a skin surface of 0.2 to 1.2 W/(m°

C.).

13. The apparatus of claim 1, wherein the energy delivery device is an RF electrode and the energy resource provides a controlled delivery of energy to operate with a frequency modulation of 250 KHz to 4 MHz.

14. The apparatus of claim 1, wherein the energy delivery device is a dielectric heating delivery device and the energy resource provides a controlled delivery of energy in the range of 4 MHz to 60 MHz.

15. The apparatus of claim 1, wherein the energy delivery device is a microwave antenna and the energy resource provides a controlled delivery of energy in the range of 915 MHz to 2,450 MHz.

16. The apparatus of claim 1, wherein the energy resource includes:

an energy control signal generator that generates an energy control signal to control energy supplied from an energy source to the energy delivery device;

a temperature measurement circuitry coupled to the energy delivery device and configured to measure a temperature of a selected site at the skin surface.

17. The apparatus of claim 16, further comprising:

an energy source configured to supply energy to the energy delivery device, wherein the energy source is responsive to the control signal to supply energy to the energy delivery device.

18. The apparatus of claim 16, wherein the temperature measuring circuitry comprises:

a first device for determining the minimum temperature value;

a target determining device coupled to the first device configured to determine the target temperature value as a function of the minimum temperature value; and

a first comparison device for comparing measured temperature values to the target temperature value and generating a signal indicating whether the measured temperature value exceeds the target temperature value.

19. Apparatus of claim 16, wherein the temperature measurement circuitry includes a microprocessor controller.

20. The apparatus of claim 1, wherein the energy resource includes:

an energy control signal generator that generates an energy control signal to control energy supplied from an energy source to the energy delivery device.

21. The apparatus of claim 20, further comprising:

an energy source coupled to the energy delivery device and configured to supply energy to the energy delivery device, wherein the energy source is responsive to the control signal to supply energy to the energy delivery device.

22. The apparatus of claim 1, wherein the energy delivery device provides resistive heating.

23. The apparatus of claim 22, wherein the energy delivery device comprises one or more resistive heating coils.

24. The apparatus of claim 1, wherein the energy resource includes impedance measuring circuitry coupled to the energy delivery device and configured to measure an impedance of one of a selected site at the skin surface or the energy delivery device.

25. The apparatus of claim 24, wherein the impedance measuring circuitry determines a minimum impedance value to determine a target measurement value as a function of the minimum measurement value and compares the measured measurement values to the target measurement value and alter the control signal when said measured measurement value exceeds the target measurement value.

26. The apparatus of claim 24, wherein the impedance measuring circuitry comprises:

a first device for determining the minimum impedance value;

a target determining device coupled to the first device configured to determine the target impedance value as a function of the minimum impedance value; and

a first comparison device for comparing measured impedance values to the target impedance value and generating a signal indicating whether the measured impedance value exceeds the target impedance value.

27. The apparatus of claim 24, wherein the impedance measurement circuitry includes a microprocessor controller.

28. The apparatus of claim 1, wherein the introduction member coupled to the template is configured to retain the flowable cooling media within the introduction member during the remodeling of the soft tissue structure.

29. The apparatus of claim 1, wherein the introduction member coupled to the template is configured to introduce the flowable cooling media to the skin surface during the remodeling of the soft tissue structure.

30. The apparatus of claim 1, wherein the conductivity of the semiconductive material ranges from 10⁻

4 to 10³ (ohm-cm)<sup>−

1</sup>.

31. The apparatus of claim 1, wherein the conductivity of the semiconductive material ranges from 10⁻

4 to 1 (ohm-cm)<sup>−

1</sup>.

32. The apparatus of claim 1, wherein the semiconductive material is a semiconductive polymer.

33. The apparatus of claim 32, wherein the semiconductive polymer is metallophthalocyanine.

34. The apparatus of claim 1, wherein the semiconductive material is a conformable polymer coated with germanium.

35. The apparatus of claim 34, wherein the conformable polymer is selected from the group consisting of polyurethanes, silicones and polytetrafluoroethylene.

36. An apparatus for remodeling of a soft tissue structure underneath the skin surface, comprising:

a template comprising a layer that is made of semiconductor material and having a curved skin interface surface that substantially conforms to the general three-dimensional contour of the soft tissue structure;

an energy delivery device coupled to the template;

a flowable cooling media introduction member coupled to the template; and

an energy resource configured to controllably deliver energy from the energy delivery device to the skin surface,

wherein the energy resource includes a flow rate signal generator that generates a flow rate control signal to control cooling media supplied from a cooling media source to the flowable cooling media introduction member; and

flow rate measurement circuitry coupled to the flowable cooling media introduction member and configured to measure a flow rate of the cooling media at the skin surface.

37. The apparatus of claim 36, further comprising:

a cooling media source coupled to the flowable cooling media introduction member, wherein the cooling media source is responsive to the flow rate control signal to supply cooling media to the cooling media introduction member.

38. The apparatus of claim 36, wherein the flow rate measuring circuitry comprises:

a first device for determining the minimum flow rate value;

a target determining device coupled to the first device configured to determine the target flow rate value as a function of the minimum flow rate value; and

a first comparison device for comparing measured flow rate values to the target flow rate value and generating a signal indicating whether the measured flow rate value exceeds the target flow rate value.

39. The apparatus of claim 36, wherein the flow rate measurement circuitry includes a microprocessor controller.

40. An apparatus for remodeling of a soft tissue structure underneath the skin surface, comprising:

a template comprising a skin-contacting layer that is made of semiconductive material and has a curved skin interface surface that substantially conforms to the general three-dimensional contour of the soft tissue structure, and a non-skin-contacting layer that is rigid and adopts a desired shape of the soft tissue structure;

an energy delivery device coupled to the template; and

an energy resource configured to controllably deliver energy from the energy delivery device to the skin surface.

41. The apparatus of claim 40, further comprising:

a flowable cooling media introduction member coupled to the template.