Apparatus for tissue remodeling

• US 6,430,446 B1
• Filed: 03/28/1997
• Issued: 08/06/2002
• Est. Priority Date: 05/05/1995
• 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:
  US08/827,237
• Time in Patent Office: 1,957 Days
• Field of Search: 606/32-52, 604/19, 604/20, 607/108-112, 607/98, 607/99, 607/101, 607/102
• US Class Current: 607/101
• 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 18/12 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 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/0047 Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00523 Treatment of incontinence
• CPC Class Codes: A61B 2018/0066 without feedback, i.e. open loop control
• 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 2/12 Mammary prostheses and implants
• CPC Class Codes: A61N 1/28 Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2/002 in combination with another treatment
• 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
• CPC Class Codes: G06F 16/9017 using directory or table look-up use of a directory or look-up table in file systems G06F16/13
• CPC Class Codes: G10L 2015/0631 Creating reference templates; Clustering

Abstract

An apparatus to modify a skin surface or a soft tissue structure underlying the skin surface includes a template with a mechanical force application surface and a receiving opening to receive a body structure. The mechanical force application surface is configured to receive the body structure and apply pressure to the soft tissue structure. An energy delivery device is coupled to the template. The energy delivery device is configured to deliver sufficient energy to the template to form a template energy delivery surface.

Claims

1. An apparatus for remodeling a tissue structure of a host to adopt a desired shape, the apparatus comprising:

a template including a mechanical force application surface which adopts the desired shape of the tissue structure and conforms to the skin surface overlaying the tissue structure of the host when an external mechanical force is applied to the template through the mechanical application surface; and

an electromagnetic energy delivery device incorporated into the template for delivering electromagnetic energy to the tissue structure through the skin surface while the mechanical force is being applied to the tissue structure;

wherein delivering the electromagnetic energy by the apparatus causes the tissue beneath the skin surface to be gradually modified by the combined application of the mechanical force and the electromagnetic energy such that the three-dimensional tissue structure of the host is remodeled to adopt desired shape.

2. The apparatus of claim 1, wherein the mechanical force application surface is a pressure application surface that is configured to apply a pressure mechanical force to the underlying tissue structure.

3. The apparatus of claim 2, wherein the mechanical force application surface is a positive pressure application surface that is configured to apply a compression force to the underlying tissue structure.

4. The apparatus of claim 2, wherein the mechanical force application surface is a negative pressure application surface that is configured to apply an extension force to the underlying tissue structure.

5. The apparatus of claim 2, wherein the mechanical force application surface is a pressure application surface that is configured to apply a shearing force to the underlying tissue structure.

6. The apparatus of claim 1, wherein the mechanical force application surface is a compression application surface that is configured to apply a compression mechanical force that is capable of creating an extension and compression of the underlying tissue structure.

7. The apparatus of claim 1, wherein the mechanical force application surface is configured to apply a substantially even pressure to the underlying tissue structure.

8. The apparatus of claim 1, wherein the mechanical force application surface is configured to supply a variable pressure to the skin surface.

9. The apparatus of claim 8, wherein the mechanical force application surface is configured to apply a substantially even pressure to the underlying tissue structure.

10. The apparatus of claim 1, wherein the template is a garment wearable by the host.

11. The apparatus of claim 10, wherein the garment is a tight fitting garment.

12. The apparatus of claim 11, wherein the tight fitting garment is a bra.

13. The apparatus of claim 12, wherein the bra is supported by a strap.

14. The apparatus of claim 1, further comprising:

a reverse thermal gradient device coupled to the template.

15. The apparatus of claim 14, wherein the reverse thermal gradient device is a cooling media delivery device coupled to the template.

16. The apparatus of claim 14, wherein the reverse thermal gradient device is a closed loop cooling channel positioned in an interior of the template.

17. The apparatus of claim 14, wherein the reverse thermal gradient device is a closed loop cooling channel positioned at the mechanical force application surface.

18. The apparatus of claim 1, wherein the template is configured to deliver sufficient electromagnetic energy and pressure to collagen in the tissue structure to cleave collagen cross-links and contract a longitudinal axis of a collagen fibril.

19. The apparatus of claim 1, further comprising:

a sensor coupled to the template for measuring a condition of the skin surface.

20. The apparatus of claim 19, further comprising:

a feedback control system coupled to the sensor to receive a measured value from the sensor and coupled to the energy delivery device to permit adjustment of a delivery of energy to the energy delivery device in response to the measured value from the sensor.

21. The apparatus of claim 20, wherein the feedback control system provides a controlled delivery of energy from an energy source to the energy delivery device.

22. The apparatus of claim 20, wherein the feedback control system is configured to minimize an ablation of the skin surface.

23. The apparatus of claim 20, wherein the feedback control system provides a controlled delivery of electromagnetic energy to the skin surface that does not exceed 1,000 joules/cm² with a single application of energy in response to the measured value from the sensor.

24. The apparatus of claim 20, wherein the feedback control system provides a controlled dose rate of electromagnetic energy to the skin surface of no more than 10 joules/sec/cm² with a single application of energy in response to the measured value from the sensor.

25. The apparatus of claim 20, wherein the feedback control system provides a controlled delivery of electromagnetic energy to a skin surface to operate in an impedance range at the skin surface of 10 ohms cm² measured at a frequency of 88 Hz to 40 Kohms cm² measured at a frequency of 10 KHz with a single application of energy in response to the measured value from the sensor.

26. The apparatus of claim 20, wherein the feedback control system adjusts a frequency of the electromagnetic energy to correspond to a selected energy delivery dose rate at the skin surface with a single application of energy in response to the measured value from the sensor.

27. The apparatus of claim 20, wherein the feedback control system adjusts a frequency of the electromagnetic energy to correspond to a selected temperature at the skin surface with a single application of energy in response to the measured value from the sensor.

28. The apparatus of claim 20, wherein the feedback control system provides a controlled delivery of electromagnetic energy to operate in a range of thermal conductivity at a skin surface of 0.21 to 0.60 k with a single application of energy in response to the measured value from the sensor.

29. The apparatus of claim 20, wherein the feedback control system provides a controlled delivery of electromagnetic energy to operate in a range of compression force applied to the underlying tissue structure not exceeding 400 mmHg in response to the measured value from the sensor.

30. The apparatus of claim 20, wherein the energy delivery device is an RF electrode and the feedback control system provides a controlled delivery of electromagnetic energy to operate with a frequency modulation of 250 KHz to 4 MHz in response to the measured value from the sensor.

31. The apparatus of claim 20, wherein the energy delivery device is a dielectric heating delivery device and the feedback control system provides a controlled delivery of electromagnetic energy in the range of 4 MHz to 60 MHz in response to the measured value from the sensor.

32. The apparatus of claim 20, wherein the energy delivery device is a microwave antenna and the feedback control system provides a controlled delivery of electromagnetic energy in the range of 915 MHz to 2,450 MHz.

33. The apparatus of claim 20, wherein the feedback control system further comprises:

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

an impedance measurement circuitry coupled to the energy delivery device and capable of measuring an impedance of a selected site at the skin surface.

34. The apparatus of claim 33, wherein the impedance measurement circuitry includes circuitry that is configured to compare a measured impedance value to a target impedance value and alter the energy control signal when the measured impedance value exceeds the target impedance value.

35. The apparatus of claim 33, further comprising:

an energy source coupled to the energy control signal generator.

36. The apparatus of claim 33, wherein the impedance measuring circuitry comprises:

a first device which determines a minimum impedance value;

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

a first comparison device which compares measured impedance values to the target impedance value and generates a signal indicating whether the measured impedance value exceeds the target impedance value.

37. The apparatus of claim 20, wherein the impedance measurement circuitry includes a microprocessor controller.

38. The apparatus of claim 19, wherein the sensor is a thermal sensor.

39. The apparatus of claim 19, wherein the sensor is an impedance sensor.

40. The apparatus of claim 19, wherein the sensor is a hydration sensor.

41. The apparatus of claim 19, wherein the sensor is a thermal conductivity sensor.