DEVICES AND METHODS FOR PERCUTANEOUS ENERGY DELIVERY

• US 20100010486A1
• Filed: 10/10/2008
• Published: 01/14/2010
• Est. Priority Date: 07/14/2008
• Status: Active Grant

• Current Assignee: Syneron Medical Limited (Syneron Incorporated)
• Original Assignee: Primaeva Medical, Inc. (Syneron Incorporated)
• Inventors: MEHTA, Bankim H., McGILL, Scott A.
• Granted Patent: US 9,066,738 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/203 applying laser energy to the outside of the body
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1807 using light other than laser radiation
• CPC Class Codes: A61B 2018/208 with multiple treatment beams not sharing a common path, e.g. non-axial or parallel
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

The invention provides a system and method for percutaneous energy delivery in an effective, manner using one or more probes. Additional variations of the system include array of probes configured to minimize the energy required to produce the desired effect.

Claims

1. An energy delivery device for delivering energy from an energy supply unit to a target region beneath a surface of tissue, the device comprising:

a device body having a tissue engaging surface, here the tissue engaging surface allows orientation of the device body on the surface of tissue;

a first plurality of energy transfer elements being advanceable from the device body at an oblique angle relative to the tissue engaging, surface;

a stabilization plate adjacent to the tissue engaging surface and being spaced from the plurality of energy transfer elements; and

a connector adapted to couple the energy supply unit to the plurality of energy transfer elements;

wherein the tissue engaging surface and stabilization plate are positioned such that when the tissue engaging surface is placed on the surface of tissue and the first plurality of energy transfer elements is advanced into the surface of tissue at an entry point, the first plurality of energy transfer elements enters the tissue at the oblique angle relative to the tissue surface while the tissue engaging surface and the stabilization plate reduce movement of the surface of tissue adjacent to the entry point.

2. The energy delivery device of claim 1, where the device body further includes a handle portion.

3. The energy delivery device of claim 1, where at least one of the energy transfer elements comprises a visual indicator for confirming depth of placement.

4. The energy delivery device of claim 1, where power supply is configured to deliver sufficient energy to the first plurality of energy transfer elements to create an energy delivery region in tissue

5. The energy delivery device of claim 4, further comprising a window located between the stabilization plate and the tissue engaging surface, where the window is configured to permit direct visualization of advancement of the energy transfer elements into the entry point.

6. The energy delivery device of claim 5, where the window is sized to outline a perimeter of the energy delivery region created by the energy transfer elements.

7. The energy delivery device of claim 5, where the window is sized to outline a distal length of the energy transfer elements when extended.

8. The energy delivery device of claim 4, where the stabilization plate is sized to outline a perimeter of the energy delivery region created by the energy transfer elements.

9. The energy delivery device of claim 4, where the stabilization plate is sized to outline a distal length of the energy transfer elements when extended.

10. The energy delivery device of claim 4, where the window and the stabilization plate are sized to outline a perimeter of the energy delivery from the energy transfer elements.

11. The energy delivery device of claim 4, where the window comprises an opening in the stabilization plate.

12. The energy delivery device of claim 4, where the stabilization plate comprises a transparent material and where the window comprises a marking in the stabilization plate.

13. The energy delivery device of claim 4, where the stabilization plate comprises a translucent material and where the window comprises a marking in the stabilization plate.

14. The energy delivery device of claim 1, further comprising a cooling source coupled to stabilization plate, such that the stabilization plate maintains a temperature at, below, or slightly above body temperature.

15. The energy delivery device of claim 14, where the cooling source comprises at least one heat pipe, where the heat pipe permits a portion of the cooling source to be located at a proximal end of the device body.

16. The energy delivery device of claim 14, where the cooling source comprises a cooling supply selected from the group consisting of a thermo electric cooler, a fan, a cooling fluid.

17. The energy delivery device of claim 1, where a surface of the stabilization plate is configured to change color in response to a rise in temperature.

18. The energy delivery device of claim 1, where a stabilization plate further comprises a suction lumen.

19. The energy delivery device of claim 1, where a stabilization plate further comprises a surface having a feature selected from the group consisting of projections, barbs, and a rough surface.

20. The energy delivery device of claim 14, where the cooling source compresses a cooling source selected from the group consisting of a thermoelectric cooling device, a fluid cooling device, a phase-change type material that absorbs heat during the phase change.

21. The energy delivery device of claim 20, where the cooling source is spaced apart from the stabilization plate to prevent visual interference of the stabilization plate.

22. The energy delivery device of claim 1, further comprising a display unit located on a portion of the device body.

23. The energy delivery device of claim 22, where the display unit is configured to display one or more parameters of the energy delivery unit.

24. The energy delivery device of claim 1, where the first plurality of energy transfer elements is arranged in a first array and where the energy delivery device further comprises at least a second plurality of energy transfer elements arranged in a second array.

25. The energy delivery device of claim 24, where the first plurality of energy transfer elements comprise a first length, and the second plurality of energy transfer elements comprise a second length, where the first and second length are not equal such that upon insertion into tissue, each plurality of needles extends a same vertical length into the tissue.

26. The energy delivery device of claim 24, where at least one of the first plurality of energy transfer elements are offset from the second plurality of energy transfer elements such that upon insertion into tissue, the plurality of energy transfer elements does not create a continuous line of insertion points along the tissue surface.

27. The energy delivery device of claim 24, where the first plurality of energy transfer elements comprises a plurality of electrode pairs, where at least one electrode pair is vertically offset from an adjacent electrode pair so that insertion of electrode pairs into the tissue does not create a continuous line of insertion points.

28. The energy delivery device of claim 27, where at least one of the electrode pairs is axially offset from an adjacent electrode pair.

29. The energy delivery device of claim 1, further comprising a cartridge body removably coupled to the device body, where at least the plurality of first electrodes and the tissue engaging surface are located on or in the cartridge body.

30. The energy delivery device of claim 1, where the first plurality of electrodes are coupled to an actuator, where movement of the actuator causes advancement or retraction of the first plurality of electrodes.

31. The energy delivery device of claim 30, where the actuator is coupled to a spring means and is spring loaded.

32. The energy delivery device of claim 31, where the spring means comprises a spring force when restrained and when unrestrained applies the spring force to the actuator to drive electrode assembly from a retracted position to a treatment position with sufficient force or speed for the energy transfer elements to penetrate the tissue surface.

33. The energy delivery device of claim 30, where movement of the actuator causes advancement or retraction of the first plurality of electrodes with sufficient force to permit the energy transfer elements to penetrate the tissue surface.

34. The energy delivery device of claim 20, where the actuator is slidable or rotatable relative to the device body.

35. The energy delivery device of claim 20, where the device body is configured to allow single handed deployment of the actuator.

36. The energy delivery device of claim 20, where the actuator is coupled to a compressed fluid cylinder, having a valve for driving the actuator.

37. The energy delivery device of claim 20, where the actuator is coupled to an electric actuator or motor.

38. The energy delivery device of claim 20, where the actuator comprises a printed circuit board.

39. The energy delivery device of claim 1, where at least one of the energy transfer elements comprises a temperature detecting element.

40. The energy delivery device of claim 1, where the stabilization plate includes a temperature detecting element.

41. The energy delivery device of claim 1, where the stabilization plate comprises a material selected from the group consisting, of steel, aluminum, silver, old, and copper.

42. The energy delivery device of claim 1, where each of the energy transfer elements has a respective impedance along a respective active region, and wherein the impedance of at least one of the energy transfer elements varies along its respective active region.

43. The energy delivery device of claim 42, where the impedance of each of the first plurality of energy transfer elements varies along the respective active region.

44. The energy delivery device of claim 1, where at least one electrode in the first plurality of energy transfer elements comprises a section of insulation over a portion of an active region.

45. The energy delivery device of claim 1, where the device body further comprises an ink-pad having ink and located on an exterior surface, where the ink pad marks tissue upon contact therewith.

46. The energy delivery device of claim 1, where the device body further comprises a marking lumen for splaying an ink on an exterior surface of the tissue.

47. The energy delivery device of claim 19, where the cartridge body further comprises a marking lumen for spraying an ink on an exterior surface of the tissue.

48. The energy delivery device of claim 1, where the tissue engaging surface further comprises at least one sensor for detecting contact with the surface of tissue.

49. The energy delivery device of claim 1, where at least one of the energy transfer elements comprises a sensor for measuring at leas one tissue parameter.

50. The energy delivery device of claim 49, where the sensor is a temperature sensor located within the at least one of the energy transfer elements.

51. The energy delivery device of claim 49, where the least one tissue parameter comprises electrical impedance, the phase angle of the electrical impedance, acoustic impedance, hydration, moisture content, electromagnetic reflectance/absorption, temperature, movement, and elasticity.

52-116. -116. (canceled)

117. A system configured to treat tissue, the system comprising:

all array of electrically isolated electrode pairs adapted to penetrate the tissue; and

a controller for providing energy to at least one of the electrode pairs in the array of electrode pairs, where the controller independently controls application of energy between electrode pairs in the array to confine flow of energy to between each electrode in the pair to create a plurality of fractional lesions within the tissue between adjacent electrode pairs.

118. The device of claim 117, further comprising at least one sensing element in communication with the controller to monitor at least one tissue condition adjacent to at least one electrode pair, and where the controller is configured to adjust the application energy in response to the local tissue condition.

119. The system of claim 118, where the tissue condition is a temperature of the tissue.

120. The system of claim 118, where the tissue condition is an impedance of the tissue.

121. The system of claim 117, where the fractional lesions are totally embedded within the tissue.

122. The system of claim 117, where the electrode pairs comprise an active area spaced from an end of the electrodes, and where the active area creates the fractional lesion over a surface of the active area.

123-127. -127. (canceled)