Apparatus and method for inhibiting pain signals transmitted during a skin related medical treatment

• US 20060293722A1
• Filed: 08/03/2006
• Published: 12/28/2006
• Est. Priority Date: 08/02/2002
• Status: Active Grant

• Current Assignee: Candela Corporation
• Original Assignee: Candela Corporation
• Inventors: Slatkine, Michael, Shavit, Raphael
• Granted Patent: US 7,740,600 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• 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 2017/00747 Dermatology
• CPC Class Codes: A61B 2017/00752 Hair removal or transplantation
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/00458 Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
• CPC Class Codes: A61B 2018/00476 Hair follicles
• 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: A61H 7/008 Suction kneading
• CPC Class Codes: A61H 9/005 Pneumatic massage
• CPC Class Codes: A61H 9/0057 Suction suction kneading A61H7/008
• CPC Class Codes: A61M 5/422 Desensitising skin
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• 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

Abstract

An apparatus adapted to inhibit pain signals generated by pain receptors in the skin during a skin related medical treatment such as an injection. An evacuation chamber is provided with an essentially rigid interface element larger than a threshold surface area through which a medical treatment can be administered to a selected skin region, one or more walls which are placeable in the vicinity of the skin region, an interior defined by the walls and by the interface element, and an opening at the bottom of the interior which is sealable by the skin region. A device generates a vacuum within the evacuation chamber interior to a level greater than the threshold vacuum level suitable for drawing the skin region through the opening towards, and in a compressing relation against, the interface element, to inhibit the transmission of a pain signal generated by pain receptors located within the skin region.

Claims

1. An apparatus which is adapted to inhibit pain signals generated by pain receptors in the skin during a skin related medical treatment from being transmitted to the brain by inducing a controlled compression of a skin region, comprising:

a) an evacuation chamber comprising an essentially rigid interface element through which a medical treatment can be administered to a selected skin region, one or more walls which are placeable on, or in the vicinity of, said skin region, an interior defined by at least said one or more walls and by said interface element, and an opening at the bottom of said interior which is sealable by said skin region;

b) means for generating a vacuum within said evacuation chamber interior, the level of the generated vacuum being suitable for drawing said skin region through said opening towards, and in a compressing relation against, said interface element, whereby to inhibit the transmission of a pain signal generated by pain receptors located within said skin region; and

c) means for administering a skin related medical treatment, said administering means adapted to pass through said interface element and to be directed to said compressed and pain inhibiting skin region.

2. The apparatus according to claim 1, wherein the surface area of the interface element is greater than a threshold surface area suitable for inhibiting the transmission of a pain signal generated by pain receptors located within the skin region.

3. The apparatus according to claim 2, wherein the threshold surface area is at least 100 mm².

4. The apparatus according to claim 2, wherein the vacuum level within the evacuation chamber is greater than a threshold vacuum level suitable for inhibiting the transmission of a pain signal generated by pain receptors located within the skin region.

5. The apparatus according to claim 4, wherein the threshold vacuum level is at least 150 mmHg.

6. The apparatus according to claim 5, wherein the threshold vacuum level is at least 400 mmHg.

7. The apparatus according to claim 1, wherein the vacuum generating means comprises a vacuum pump in fluid communication with the evacuation chamber.

8. The apparatus according to claim 1, wherein the vacuum generating means is a vacuum source in fluid communication with the evacuation chamber and means for isolating said vacuum source from the evacuation chamber interior.

9. The apparatus according to claim 1, further comprising control means for synchronizing the activation of the vacuum generating means.

10. The apparatus according to claim 9, wherein the control means is a mechanical control means.

11. The apparatus according to claim 9, wherein the control means comprises a controller and a skin contact detector in communication with said controller for sensing the placement of the evacuation chamber onto the skin region, said controller adapted to generate a first signal for activating the vacuum generating means following placement of the evacuation chamber onto the skin region and to generate a second signal for deactivating the vacuum generating means a predetermined duration following generation of said first signal.

12. The apparatus according to claim 11, wherein the duration of the generated vacuum is no longer than approximately 6 seconds.

13. The apparatus according to claim 11, wherein the control means further comprises a pressure sensor in fluid communication with the interior of the evacuation chamber and in electrical communication with the controller, the controller being further adapted to control the operation of the vacuum generating means so that a predetermined pain inhibiting vacuum level ranging between 400 mmHg and 1 atmosphere will be generated within the evacuation chamber.

14. The apparatus according to claim 11, wherein the vacuum generating means comprises at least one control valve, the controller being suitable for delivering air through said at least one control valve in order to increase the pressure in the evacuation chamber to atmospheric pressure following the generation of the second signal, to allow for effortless repositioning of the evacuation chamber to a second skin region, the control means being selected from the group of electronic means, pneumatic means, electrical means, and optical means.

15. The apparatus according to claim 11, wherein the skin contact detector is an opto-coupler or a microswitch.

16. The apparatus according to claim 7, wherein the vacuum pump is a dual air-gel vacuum pump.

17. The apparatus according to claim 1, wherein the interface element is pre-compressed.

18. The apparatus according to claim 1, wherein the interface element is planar.

19. The apparatus according to claim 18, wherein the interface element is retained in a cover element attached to one or more sidewalls.

20. The apparatus according to claim 1, wherein the interface element is curvilinear.

21. The apparatus according to claim 22, wherein the interface element is retained by one or more sidewalls.

22. The apparatus according to claim 1, which is suitable for the painless administration of medical treatments selected from the group of ultrasonic-based hair removal, ultrasonic-based collagen tightening, ultrasonic-based blood vessel sealing, ultrasonic-based treatment of fatty or cellulite tissue, injections for vaccines, injections for the administration of drugs, injection of collagen, mesotherapy, removal of hair with a hand held implement, needle epilation, injection of collagen within the epidermis, tattoo removal, and the treatment of pigmented lesions.

23. The apparatus according to claim 1, wherein the means for administering the medical treatment is an injection needle.

24. The apparatus according to claim 23, wherein the interface element is puncturable.

25. The apparatus according to claim 23, wherein the interface element is an apertured interface element, an injection needle being introducible through each of said apertures.

26. The apparatus according to claim 25, wherein the total area of the apertures is less than 20% of the total area of the interface element.

27. The apparatus according to claim 24, wherein the interface element is a subdivided interface element.

28. The apparatus according to claim 25, wherein the apertures are covered by a shield element.

29. The apparatus according to claim 28, wherein the shield element is placed directly on top of the interface element.

30. The apparatus according to claim 28, wherein a seal element is interposed between the shield element and the interface element.

31. The apparatus according to claim 28, wherein marks corresponding to the location of the apertures are indicated on the upper face of the shield.

32. The apparatus according to claim 25, further comprising means for maintaining the vacuum within the evacuation chamber following termination of the vacuum generating means.

33. The apparatus according to claim 32, wherein the vacuum maintaining means comprises a plurality of rims connected to the underside of the apertured interface element, each of said rims encircling a corresponding aperture formed in the interface element and adapted to produce a volume of negative pressure within the evacuation chamber for drawing the skin region in compressing relation against the interface element following termination of the vacuum generating means, said volume being enclosed by the interface element, rim, and drawn skin region or being enclosed by the interface element, evacuation chamber sidewall, and drawn skin region,

34. The apparatus according to claim 25, further comprising means for guiding the injection needle through an aperture to the drawn skin region.

35. The apparatus according to claim 34, further comprising means for administering a plurality of injection needles.

36. The apparatus according to claim 35, wherein the means for administering a plurality of injection needles comprises a bar for holding a plurality of needle applicators therebelow and a guide track substantially perpendicular to said bar.

37. The apparatus according to claim 1, wherein an evacuation chamber sidewall is an interface element.

38. The apparatus according to claim 37, wherein the evacuation chamber is configured as a slit defined by elongated, planar sidewalls and by a rigid upper surface extending between, and having a considerably shorter length than, said sidewalls.

39. The apparatus according to claim 8, wherein the volume of the vacuum source is at least twice the volume of the evacuation chamber.

40. The apparatus according to claim 8, wherein the vacuum source is a pre-evacuated container.

41. The apparatus according to claim 40, wherein the isolation means is openable by control means.

42. The apparatus according to claim 41, wherein the isolation means is a valve.

43. The apparatus according to claim 41, wherein the isolation means is a breakable stop.

44. The apparatus according to claim 41, wherein the control means is a controller and a skin contact detector in communication with said controller for sensing the placement of the evacuation chamber onto the skin region, said controller adapted to generate a signal for opening the isolation means following placement of the evacuation chamber onto the skin region.

45. The apparatus according to claim 41, wherein the control means comprises a pin placeable on the skin region, the pointed end of said pin adapted to pierce a membrane stretched across the interior of a conduit extending between the pre-evacuated container and the evacuation chamber once the evacuation chamber is placed on the skin region.

46. The apparatus according to claim 41, wherein the control means further comprises a valve in communication with both the conduit and surrounding ambient air, said valve being openable whereby to release the vacuum by kinematic means a predetermined period of time following placement of the evacuation chamber on the skin region.

47. The apparatus according to claim 40, wherein the pre-evacuated container is integrally connected to the evacuation chamber.

48. The apparatus according to claim 1, further comprising a vibrator kinematically connected to the interface element.

49. The apparatus according to claim 1, wherein the means for administering the medical treatment is a beam of ultrasonic waves and the interface element is made of a material which is transparent to ultrasonic waves.

50. The apparatus according to claim 49, wherein the ultrasonic waves have a frequency ranging from 1 to 10 MHz and are generated by means of an ultrasonic transducer.

51. An apparatus for alleviating or preventing pain caused by a treatment with electromagnetic energy of a targeted skin structure, comprising:

a) an element subjected to a generated vacuum therebelow, the level of the generated vacuum being sufficiently high to draw a skin target underlying said element towards, and in a compressing relation against, said element, whereby to alleviate or prevent the transmission of a pain signal generated by pain receptors located within said skin target; and

b) a pulsed source of electromagnetic energy for generating waves that are transmitted through said element and that are suitable for treating a skin disorder within said skin target.

52. The apparatus according to claim 51, wherein the electromagnetic energy is laser or IPL light.

53. The apparatus according to claim 51, wherein the light has a wavelength ranging from 400 to 1800 nm.

54. The apparatus according to claim 53, wherein the element which is subjected to a generated vacuum therebelow is an interface element of an evacuation chamber, said evacuation chamber further comprising one or more walls which are placeable on, or in the vicinity of, said skin region, an interior defined by at least said one or more walls and by said interface element, and an opening at the bottom of said interior which is sealable by the skin target.

55. The apparatus according to claim 54, wherein each wall of the evacuation chamber is puncturable, a darkened needle capable of piercing a wall of the evacuation chamber, attracting the optical energy of the light, and thermally damaging the surrounding skin structure.

56. The apparatus according to claim 55, wherein the light has an energy density ranging from 10 to 100 J/cm² and a pulse duration ranging from 10 to 300 millisec.

57. The apparatus according to claim 54, further comprising gliding apparatus for displacing a light source distal end over the interface element at a speed ranging from 0.3 to 40 cm/sec.

58. The apparatus according to claim 57, wherein the light source distal end is displaced by means of an optical detector that senses the presence of a marker on the interface element.

59. The apparatus according to claim 57, wherein the light source distal end is displaced by means of a texture sensing mechanism.

60. The apparatus according to claim 54, wherein the interface element is an apertured interface element, the light propagating through each of the apertures without being transmitted through the material from which the interface element is composed.

61. The apparatus according to claim 60, wherein the light is generated by a CO₂ or Erbium laser.

62. A method for inhibiting pain signals generated by pain receptors in the skin during a skin related medical treatment, comprising the steps of:

d) positioning a rigid interface element above a selected skin region;

e) applying a vacuum of a sufficient value over said skin region such that the latter is flattened and compressed against said interface element; and

f) administering a skin related medical treatment by means adapted to pass through said interface element and to be directed to said compressed skin target, whereby pain signals generated by the nervous system during said medical treatment are inhibited due to the contact of said skin region onto said interface element.

63. The method according to claim 62, wherein the surface area of the interface element is greater than a threshold surface area suitable for inhibiting the transmission of a pain signal generated by pain receptors located within the skin region.

64. The method according to claim 63, wherein the threshold surface area is at least 100 mm².

65. The method according to claim 62, wherein the vacuum level within the evacuation chamber is greater than a threshold vacuum level suitable for inhibiting the transmission of a pain signal generated by pain receptors located within the skin region.

66. The method according to claim 65, wherein the threshold vacuum level is at least 150 mmHg.

67. The method according to claim 66, wherein the threshold vacuum level is at least 400 mmHg.

68. The method according to claim 62, wherein the medical treatment is selected from the group of ultrasonic-based hair removal, ultrasonic-based collagen tightening, ultrasonic-based blood vessel sealing, ultrasonic-based treatment of fatty or cellulite tissue, injections for vaccines, injections for the administration of drugs, injection of collagen, mesotherapy, removal of hair with a hand held implement, needle epilation, injection of collagen within the epidermis, tattoo removal, the treatment of pigmented lesions, and making a small incision in the gums.

69. The method according to claim 62, wherein the duration of the applied vacuum ranges from 0.1 to 6 seconds.