US2019380766A1PendingUtilityA1

Devices, systems and methods for subdermal coagulation

57
Assignee: APYX MEDICAL CORPPriority: Jun 14, 2018Filed: Jun 13, 2019Published: Dec 19, 2019
Est. expiryJun 14, 2038(~11.9 yrs left)· nominal 20-yr term from priority
A61B 2017/320048A61B 2018/00244A61B 90/02A61B 18/14A61B 2018/00601A61B 2018/1253A61B 2018/00178A61B 2018/0022A61B 2018/00577A61B 2018/00589A61B 18/1206A61B 2018/00452A61B 2018/126A61B 2018/00702A61B 18/042
57
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Claims

Abstract

Devices, systems and methods are provided for subdermal tissue tightening through soft tissue coagulation and for use in cosmetic surgery applications. The devices, systems and methods of the present disclosure may be used for a minimally invasive application of helium-based cold plasma energy to subcutaneous tissue for the purpose of tightening lax tissue.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A surgical method comprising:
 creating an entry incision through the epidermal and dermal layers of a patient's skin;   disposing a balloon device in a subcutaneous layer through the entry incision;   inflating the balloon to dissect tissue to create a dissected tissue plane; and   applying helium-based cold plasma in the dissected tissue plane to coagulate tissue and reduce laxity in the patient's skin.   
     
     
         2 . The method of  claim 1 , wherein the applying the helium-based cold plasma includes:
 flowing helium over an energized electrode; and   ionizing a portion of the flowing helium to generate the cold plasma for coagulating the tissue,   wherein an un-ionized portion of the flowing helium removes heat from the coagulated tissue.   
     
     
         3 . The method of  claim 2 , wherein the ionized portion is approximately less than 0.1% of the volume of the flowing helium and the un-ionized portion is approximately greater than 99.9% of the volume of the flowing helium. 
     
     
         4 . The method of  claim 1 , wherein the balloon device is disposed in a subcutaneous layer by a tunneling member. 
     
     
         5 . The method of  claim 1 , wherein the balloon device is disposed in a subcutaneous layer by a cold plasma generator. 
     
     
         6 . The method of  claim 5 , wherein the balloon is inflated with helium supplied by the cold plasma generator. 
     
     
         7 . The method of  claim 1 , wherein the helium-based cold plasma is applied in a wanding motion to optimize distribution of the plasma. 
     
     
         8 . The method of  claim 1 , further comprising deflating the balloon device and removing the balloon device before the applying of the helium-based cold plasma. 
     
     
         9 . The method of  claim 1 , wherein the balloon device remains inflated during the applying of the helium-based cold plasma to promote flow of the plasma to extremities of the dissected tissue plane. 
     
     
         10 . The method of  claim 1 , wherein the balloon device is configured to correspond to an area of skin of a patient to be tightened. 
     
     
         11 . The method of  claim 10 , wherein the balloon device is configured to correspond to at least one of a patient's buttocks, abdomen, arms, legs, neck, forehead and/or chin. 
     
     
         12 . The method of  claim 1 , wherein the helium-based cold plasma finds tissue that represents the path of least resistance for flow of RF energy in a plasma beam, further comprising drawing the helium-based cold plasma through the dissected tissue plane such that the path of least resistance constantly changes to effect 360 degree tissue treatment. 
     
     
         13 . The method of  claim 12 , wherein the path of least resistance is individual bands of a fibroseptal network in the dissected tissue plane. 
     
     
         14 . The method of  claim 12 , wherein the path of least resistance is tissue having a lowest impedance relative to adjacent tissue. 
     
     
         15 . The method of  claim 1 , wherein the helium-based cold plasma is applied at a constant power output level for a range of tissue impedances. 
     
     
         16 . The method of  claim 1 , wherein the helium-based cold plasma is applied at a power output level of about 40 watts for tissue impedances on a range of about 125 ohms to at least about 5000 ohms. 
     
     
         17 . A system comprising:
 an electrosurgical generator coupled to a power source and configured for generating electrosurgical energy;   a plasma generator including a gas conduit and an electrode disposed within the gas conduit, the electrode operatively coupled to the electrosurgical generator to selectively receive electrosurgical energy therefrom such that the electrode at least partially ionizes a helium supplied to the gas conduit to create a plasma discharge; and   a balloon device configured to be disposed in tissue and to dissect tissue when inflated to create a dissected tissue plane,   wherein the plasma generator coagulates tissue by applying the plasma discharge in the dissected tissue plane.   
     
     
         18 . The system of  claim 17 , wherein the electrode ionizes a portion of the supplied helium to generate the plasma discharge for coagulating the tissue, wherein an un-ionized portion of the supplied helium removes heat from the coagulated tissue. 
     
     
         19 . The system of  claim 18 , wherein the ionized portion is approximately less than 0.1% of the volume of the supplied helium and the un-ionized portion is approximately greater than 99.9% of the volume of the supplied helium. 
     
     
         20 . The system of  claim 17 , further comprising a tunneling member that disposes the balloon device in a subcutaneous layer of tissue. 
     
     
         21 . The system of  claim 17 , wherein the balloon device is coupled to the plasma generator and is disposed in a subcutaneous layer of tissue by the plasma generator. 
     
     
         22 . The system of  claim 21 , wherein the balloon device is inflated with helium supplied by the plasma generator. 
     
     
         23 . The system of  claim 17 , wherein the balloon device is configured to correspond to an area of skin of a patient to be tightened. 
     
     
         24 . The system of  claim 17 , wherein the balloon device is configured to correspond to at least one of a patient's buttocks, abdomen, arms, legs, neck, forehead and/or chin. 
     
     
         25 . The system of  claim 17 , wherein the plasma discharge finds tissue that represents the path of least resistance for flow of RF energy in a plasma discharge and, upon movement of the plasma generator through the dissected tissue plane, the path of least resistance constantly changes to effect 360 degree tissue treatment of the plasma discharge. 
     
     
         26 . The system of  claim 25 , wherein the path of least resistance is individual bands of a fibroseptal network in the dissected tissue plane. 
     
     
         27 . The system of  claim 25 , wherein the path of least resistance is tissue having a lowest impedance relative to adjacent tissue. 
     
     
         28 . The system of  claim 17 , wherein the electrosurgical energy is applied to the electrode at a constant power output level for a range of tissue impedances. 
     
     
         29 . The system of  claim 17 , wherein the electrosurgical energy is applied at a power output level of about 40 watts for tissue impedances on a range of about 125 ohms to at least about 5000 ohms. 
     
     
         30 . An electrosurgical handpiece comprising:
 a plasma generator including a gas conduit and an electrode disposed within the gas conduit, the electrode operatively coupled to an electrosurgical generator to selectively receive electrosurgical energy therefrom such that the electrode at least partially ionizes a helium supplied to the gas conduit to create a plasma discharge at the distal end of the gas conduit; and   a balloon device coupled to the gas conduit and configured to be disposed in tissue and to dissect tissue when inflated to create a dissected tissue plane,   wherein the plasma generator coagulates tissue by applying the plasma discharge in the dissected tissue plane.   
     
     
         31 . The electrosurgical handpiece of  claim 30 , wherein the electrode ionizes a portion of the supplied helium to generate the plasma discharge for coagulating the tissue, wherein an un-ionized portion of the supplied helium removes heat from the coagulated tissue. 
     
     
         32 . The electrosurgical handpiece of  claim 31 , wherein the ionized portion is approximately less than 0.1% of the volume of the supplied helium and the un-ionized portion is approximately greater than 99.9% of the volume of the supplied helium. 
     
     
         33 . The electrosurgical handpiece of  claim 30 , wherein the balloon device is inflated with helium supplied by the gas conduit. 
     
     
         34 . The electrosurgical handpiece of  claim 30 , wherein the balloon device is configured to correspond to an area of skin of a patient to be tightened. 
     
     
         35 . The electrosurgical handpiece of  claim 34 , wherein the balloon device is configured to correspond to at least one of a patient's buttocks, abdomen, arms, legs, neck, forehead and/or chin. 
     
     
         36 . The electrosurgical handpiece of  claim 30 , wherein the plasma discharge finds tissue that represents the path of least resistance for flow of RF energy in a plasma discharge and, upon movement of the plasma generator through the dissected tissue plane, the path of least resistance constantly changes to effect 360 degree tissue treatment of the plasma discharge. 
     
     
         37 . The electrosurgical handpiece of  claim 36 , wherein the path of least resistance is individual bands of a fibroseptal network in the dissected tissue plane. 
     
     
         38 . The electrosurgical handpiece of  claim 36 , wherein the path of least resistance is tissue having a lowest impedance relative to adjacent tissue. 
     
     
         39 . The electrosurgical handpiece of  claim 30 , wherein the electrosurgical energy is applied to the electrode at a constant power output level for a range of tissue impedances. 
     
     
         40 . The electrosurgical handpiece of  claim 30 , wherein the electrosurgical energy is applied at a power output level of about 40 watts for tissue impedances on a range of about 125 ohms to at least about 5000 ohms. 
     
     
         41 . A surgical kit comprising:
 a sterile enclosure;   a plasma generator disposed in the sterile enclosure, the plasma generator including a gas conduit and an electrode disposed within the gas conduit, the electrode configured to be coupled to an electrosurgical generator to selectively receive electrosurgical energy therefrom such that the electrode at least partially ionizes a helium supplied to the gas conduit to create a plasma discharge at the distal end of the gas conduit; and   at least one balloon device disposed in the sterile enclosure, the at least one balloon device configured to be disposed in tissue and to dissect tissue when inflated to create a dissected tissue plane,   wherein the plasma generator coagulates tissue by applying the plasma discharge in the dissected tissue plane.   
     
     
         42 . The surgical kit of  claim 41 , wherein the electrode ionizes a portion of the supplied helium to generate the plasma discharge for coagulating the tissue, wherein an un-ionized portion of the supplied helium removes heat from the coagulated tissue. 
     
     
         43 . The surgical kit of  claim 42 , wherein the ionized portion is approximately less than 0.1% of the volume of the supplied helium and the un-ionized portion is approximately greater than 99.9% of the volume of the supplied helium. 
     
     
         44 . The surgical kit of  claim 41 , wherein the at least one balloon device is inflated with helium supplied by the gas conduit. 
     
     
         45 . The surgical kit of  claim 41 , wherein the at least one balloon device is configured to correspond to an area of skin of a patient to be tightened. 
     
     
         46 . The surgical kit of  claim 45 , wherein the at least one balloon device is configured to correspond to at least one of a patient's buttocks, abdomen, arms, legs, neck, forehead and/or chin.

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