NASAL TISSUE TREATMENT METHOD AND RELATED DEVICE

Abstract

Nasal airway reshaping is accomplished using a fractional treatment device applied externally to the nose to insert needle electrodes into nasal tissue to be reshaped. Energy is applied via the electrodes to cause at least partial coagulation of the nasal tissue within zones around each of the plurality of needle electrodes while pressure is applied internally to achieve the desired reshaping.

Claims

1. A method of reshaping a nasal airway, the method comprising: applying mechanical pressure from inside a nostril to reshape a portion the nasal airway; inserting, to a predetermined depth, a plurality of needle electrodes of a hand piece through an external skin surface of the nose into nasal tissue adjacent to the reshaped portion; and applying a predetermined amount of radiofrequency (RF) energy via the plurality of needle electrodes after insertion to cause at least partial coagulation of the nasal tissue within respective zones around each of the plurality of needle electrodes.

2. The method of claim 1, wherein a length of each of the plurality of needle electrodes is from 0.5 millimeters (mm) to 10 mm.

3. The method of claim 1, wherein a portion of each of the plurality of needle electrodes is coated with an insulating material to minimize application of RF energy adjacent to the portion.

4. The method of claim 3, wherein each portion is closer to the hand piece than a remaining, uninsulated portion of each of the plurality of nasal electrodes.

5. The method of claim 1, wherein at least four needle electrodes are inserted into the nasal tissue.

6. The method of claim 1, wherein applying the predetermined amount of RF energy includes applying the RF energy in at least one pulse having a duration of 1 millisecond to 5 seconds.

7. The method of claim 1, wherein applying the predetermined amount of RF energy via the plurality of needle electrodes includes using at least one of the plurality of needle electrodes as at least one active electrode, with a remainder of the plurality of needles electrodes being return electrodes.

8. The method of claim 7, wherein using the least one of the plurality of needle electrodes as at least one active electrode includes using only one of the plurality needle electrodes as only one active electrode.

9. The method of claim 8, wherein using only one of the plurality needle electrodes as only one active electrode includes switching which of the plurality of needle electrodes is the only one active electrode.

10. The method of claim 1, wherein applying the predetermined amount of RF energy via the plurality of needle electrodes includes using at least one of the plurality of needle electrodes as at least one active electrode and using a surface electrode applied to the external skin surface as a return electrode.

11. The method of claim 1, wherein applying the predetermined amount of RF energy via the plurality of needle electrodes is performed such that each of the respective zones is smaller than a distance between adjacent ones of the plurality of needle electrodes.

12. The method of claim 1, wherein applying the predetermined amount of RF energy via the plurality of needle electrodes includes: measuring at least one parameter during application of the RF energy, the at least one parameter including at least one of RF current, RF voltage, RF power and tissue impedance during application of the RF energy; and adjusting RF power and pulse duration according to the at least one parameter.

13. The method of claim 1, further comprising cooling nasal mucosa and the external skin surface while applying the predetermined amount of RF energy.

14. A method of reshaping a nasal airway, the method comprising: applying mechanical pressure from inside a nostril to reshape a portion the nasal airway; inserting a plurality of needle electrodes of a hand piece through an external skin surface of the nose into nasal cartilage adjacent to the reshaped portion; applying a predetermined amount of energy via the plurality of needle electrodes after insertion to heat at least a portion of the nasal cartilage above 50° Celsius (C); and cooling nasal mucosa and the external skin surface to prevent thermal damage.

15. The method of claim 14, wherein applying the predetermined amount of energy via the plurality of needle electrodes includes applying a predetermined amount of radiofrequency (RF) energy via the plurality of needle electrodes.

16. A method of reshaping a nasal airway, the method comprising: applying mechanical pressure from inside a nostril to reshape a portion the nasal airway; inserting a plurality of needle electrodes of a hand piece through an external skin surface of the nose into nasal cartilage adjacent to the reshaped portion; receiving temperature feedback from the portion of the nasal cartilage; and applying a predetermined amount of radiofrequency (RF) energy via the plurality of needle electrodes after insertion to heat at least a portion of the nasal cartilage according to the temperature feedback to maintain a predetermined temperature for a predetermined time.

17. The method of claim 16, wherein the predetermined temperature is 50° Celsius (C) to 80° C.

18. The method of claim 16, further comprising cooling the external skin surface to prevent an external skin temperature from exceeding 45° C.

19. The method of claim 16, further comprising cooling nasal mucosa to prevent a nasal mucosa temperature from exceeding 50° C.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] FIG. 1 is a schematic view of an applicator hand piece being applied to an external skin surface of the nose adjacent to nasal tissue to be treated, according to an embodiment of the present invention;

[0039] FIG. 2 is a schematic overview of an applicator assembly including the hand piece of FIG. 1 and a connected power source and microprocessor;

[0040] FIG. 3 is a close-up schematic view of a distal end of the hand piece of FIG. 1, including an electrode array;

[0041] FIG. 4 is a schematic view of the distal end of FIG. 2 with the electrode array applied to the nasal tissue to be treated and a coagulation zone created therein;

[0042] FIG. 5 is a schematic view of another embodiment of the distal end of FIG. 2, with non-insulated electrodes creating coagulation craters therealong; and

[0043] FIG. 6 is a schematic view of the hand piece of FIG. 1, further including a supporting mechanism for reshaping the nasal tissue.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0044] Referring first to FIG. 1, an applicator handpiece 10 includes a reusable handle 12 carrying a disposable tip 14 at the distal end with array 16 of electrodes applied to the nose 20. The disposable tip 14 is connected at its proximal end mechanically and electrically to the handle 12. The array 16 of electrodes is located in the distal end of the disposable tip 14. Referring to FIG. 2, the handle is connected via cable 22 to a control unit 24 including an RF generator 26 and a microprocessor 30 controlling the delivery of RF energy to the electrode array 16.

[0045] A cotton tampon is inserted into the nostril 18 to reshape the nose and enlarge the airway. The RF energy heats the cartilage tissue inside the nose resulting in cartilage stress relaxation and forming a new shape after cartilage cooling.

[0046] Referring to FIG. 3, at the distal end, the tip 14 includes a tissue application surface 32 with electrodes 34 of the electrode array 16 extending therefrom. The electrodes 34 are needle shapes with sharp ends. Upper portions 36 of each electrode 34 can be coated with a polymer to protect the skin surface from thermal damage such that only the uncoated ends deliver RF energy at a predetermined depth.

[0047] The applicator contact surface 32 is applied to the treated area with firm pressure allowing the electrodes 34 to penetrate into the tissue to deliver RF energy into the treated volume and create coagulation zones 40 around the un-insulated ends of each electrode 34. The applicator contact surface 32 could also include a return electrode and/or a cooling element.

[0048] As seen in FIG. 3, the un-insulated ends of the electrodes 34 only create the coagulation zones 40 inside the cartilage 42 while surface tissue 44 is preserved from thermal damage by insulated upper portions 36. This configuration helps avoid surface thermal damage, reduce the risk of infection and minimize healing time.

[0049] Referring to FIG. 4, in an alternate embodiment of the tip 14A (with like elements given like reference numbers followed by an “A”), the conductive elements 34A are completely uninsulated. As a result, coagulation craters 40A extend from the cartilage 42A through the surface tissue 44A. This configuration allows the generation of a larger coagulation volume.

[0050] Referring first to FIG. 5, to facilitate reshaping of the nasal airway during treatment, a supporting mechanism 50 can be connected to the handle 12 along with the disposable tip 15. The supporting mechanism 50 is configured such that a distal end thereof extends into the nostril 18 and engages the side of the treated tissue opposite the electrode array 16. Advantageously, the supporting mechanism 50 is used to enlarge the nose opening airway for better breathing. [0051] a. While the present invention is not necessarily limited thereto, preferred parameters applicator handpiece 10 and control unit 24 include: [0052] b. Up to 100 electrodes, but more preferably from 4 to 25 for easier penetration into the tissue and addressing small treatment areas. [0053] c. The average RF energy per electrode is in the range of 10 millijoules (mJ) to 5 J, with a more preferred energy range being from 20 mJ to 1 J per electrode. [0054] d. The penetration depth of the electrodes is from 0.5 mm to 10 mm. The penetration depth can be fixed or adjustable. [0055] e. RF voltage applied to the skin in the range of 10 volts (V) to 1000V. [0056] f. A pulse repetition rate from 0.2 pulses per second (pps) to 2 pps. [0057] g. A cotton tampon, rubber plug or special mechanical inserted into the nostril is used to expand nasal airway prior to and during the energy application.

[0058] In general, the foregoing description is provided for exemplary and illustrative purposes; the present invention is not necessarily limited thereto. Rather, those skilled in the art will appreciate that additional modifications, as well as adaptations for particular circumstances, will fall within the scope of the invention as herein shown and described and of the claims appended hereto.