KR20000010722A - Apparatus for cosmetically remodeling a body structure - Google Patents

Abstract

The device for reducing the volume of a selected location inside the tongue includes an electrode and a handpiece at least partially located inside the catheter. The electrode includes an electrode electromagnetic energy transfer surface and can be advanced from the interior of the handpiece into the interior of the tongue. The electrode advancing member is coupled to the electrode and is configured to advance the electrode to the advancing distance inside the tongue. This advancing distance is sufficient for the electrode electromagnetic energy transfer surface to transfer the electromagnetic energy to the selected tissue location and to reduce the volume of the selected location without damaging the surface of the tongue and / or the nerve tissue below the tongue. The cable is coupled to the electrode.

Description

Body structure remodeling device for beauty

Sleep apnea syndrome is a medical condition characterized by naps, morning pains, decreased intelligence, cardiac arrhythmias, snoring and writhing during sleep. There are many episodes of sleep apnea in patients. These syndromes fall into two types. One type of “sleep apnea syndrome” is characterized by repeated loss of respiratory activity. The second type, apnea syndrome of sleep disorders, is characterized by repeated apnea episodes during sleep caused by a part of the patient's respiratory tract that does not include the larynx and head to the head, or a disorder of the patient's upper respiratory tract.

Thus, therapies include various medical, surgical and physical measurements. Medical assays use drugs such as protriptyline, methoxide progesterone acetate, acetazolamide, diophylline, nicotine and other drugs and avoid neutrophil inhibitors such as sedatives or alcohols. These medical measures sometimes help but are not completely effective. Moreover, drugs often have undesirable side effects.

Surgical interventions include palatal pharyngeal grafts, tonsillectomy and surgical operations to correct severe upper jaw recession and tracheostomy. In one process, the jaw is moved, pulled forward, and the tongue is seen. This process can be effective, but in such patients it can be suppressed by the risk of surgery, which is often unacceptable to the patient.

Physical measurements include weight loss, nasopharyngeal airways, nasal CPAP, and various tongue holding devices used at night. While these measures are partially effective, they are cumbersome and inconvenient, and patients are often unable to continue using them for a long time. Weight loss is effective but cannot be achieved by such patients.

In patients with sleep apnea syndrome, diaphragmatic neural tissue or diaphragm pacing was used. Diaphragm nerve tissue or diaphragm pacing uses electrical stimulation to control and control the diaphragm of a patient who is symmetrically stimulated by the diaphragm nerve tissue to support or support gout. This pacing was performed from January to February 10, 1987, Part II, PACE Volume 10, Muzika Jay. Direct Diaphragm Stimulation, et al., 1985 Overview pages 263-279, Mujika J from Neurostimulation. Et al., Preliminary Test of a Muscular Diaphragm Pacing System on Human Patients, and in June 1993 in Electrical Activation of Respiration by Nochomovitez IEEE Eng.

However, most of these patients have found that the apnea of sleep disorders is getting worse when the inhalation force is increased by Pacer. Reduced gout due to the activity of the diaphragm also causes disturbances in the upper airway when inhaled and pulls the patient's tongue down the larynx to choke the patient. These patients then require tracheal opening for proper treatment.

Kaneko F. from Trans Am Soc Artif Intern Organs in 1985. Physiological laryngeal facemakers, as described in Physiological Laryngeal Pacemaker, et al., Sense the volume transferred to lung disease and stimulate appropriate neural tissue to open the patient's gates to treat dyspnea. Such a device generates a signal proportional to the air volume of the transferred lung disease so that the generated signal is too late to be used as an indicator for sleep apnea treatment. Often there is no miracle shifted from disturbed sleep apnea.

One of the effective measures of apnea in sleep disorders is tracheal aperture surgery. Surgical intervention, however, has a fairly high mortality rate and is unacceptable for many patients cosmetically. Other surgical procedures pull the tongue forward as far as possible to surgically cut and remove portions of the tongue and other structures that can close the upper airway passages.

There is a need for a method and apparatus that solves this problem.

Summary of the Invention

It is therefore an object of the present invention to provide a device for reducing the volume of a suitable location inside the tongue.

It is another object of the present invention to provide a device for reducing the volume of an appropriate position inside the tongue, including an electrode and an electrode advancement element, wherein the electrode advancement member transmits electromagnetic energy to selected tissues, thereby providing a nerve under the tongue. Advance the electrode at a forward distance inside the tongue sufficient for the electrode electromagnetic energy cut surface to reduce the volume of the selected location without damaging the tissue.

It is another object of the present invention to provide an apparatus for reducing the volume of an appropriate position inside the tongue, including an electrode and an electrode electronic member, wherein the electrode electronic member advances the electrode to the placement position inside the tongue, thereby The electromagnetic energy transfer surface can deliver sufficient electromagnetic energy to reduce the volume at selected locations without damaging the nerve tissue under the tongue.

It is another object of the present invention to provide an apparatus for reducing the volume of an electrode, an electrode electromagnetic energy transfer surface, and an electrode advance length extending from the outside of the handpiece to the inside of the tongue to a suitable position inside the tongue. This forward length places the electrode electromagnetic energy transfer surface at a suitable location and delivers sufficient electromagnetic energy to reduce the volume of the selected tissue location without damaging the nerve tissue under the tongue.

It is a further object of the present invention to provide a device for reducing the volume of a suitable location inside the tongue comprising an electrode with a geometry configured to reduce the volume of the selected location without damaging the nerve tissue underneath the tongue.

These and other objects of the present invention are achieved with a device for reducing the volume of a selected position inside the tongue. Such devices include electrodes and handpieces at least partially located inside the catheter. The electrode includes an electrode electromagnetic energy transfer surface and can be advanced from the interior of the handpiece into the interior of the tongue. The electrode advancing member is coupled to the electrode and is configured to advance the electrode to the advancing distance inside the tongue. This advancing distance is sufficient for the electrode electromagnetic energy transfer surface to transfer the electromagnetic energy to the selected tissue location and to reduce the volume of the selected location without damaging the surface of the tongue and / or the nerve tissue below the tongue. The cable is coupled to the electrode.

In another embodiment, the electrode advancement member is configured to advance at least a portion of the electrode to a placement position inside the tongue. The electrode electromagnetic energy transfer surface at the placement position delivers sufficient electromagnetic energy to reduce the volume at the selected position without damaging the nerve tissue under the tongue.

In another embodiment, the electrode has an electrode advancement length that extends from the outside of the catheter into the tongue. The advancing length locates the electrode electromagnetic energy transfer surface at a selected location and delivers sufficient electromagnetic energy to reduce the volume of the selected tissue location without damaging the nerve tissue under the tongue.

The electrode is preferably an RF electrode coupled to an RF energy source. At least a portion may be located inside the catheter and include a cooling element configured to cool the selected surface of the tongue. The flow rate control element may be coupled to the cooling element to control the cooling medium flow rate through the cooling element.

The insulator has at least a portion located around the outside of the electrode to define the electromagnetic energy cutting surface of the electrode. The sensor may be located at various locations including the distal end of the insulator, the distal end of the electrode, and the outer surface of the catheter.

In one embodiment, the first sensor is located at the distal end of the electrode and the second sensor is located at the distal end of the insulator.

The feedback control element can be coupled to the electrode, sensor and electromagnetic energy source. In addition, the injection media source can be coupled to the electrode.

The present invention relates to a method of maintaining the upper airway patency of a patient, and in particular, debulk selected portions of the tongue and / or tonsils of the tongue using electromagnetic energy without damaging the nerve tissue under the tongue. It is about how to).

1 is a cross-sectional view of an ablation apparatus used in the method of the present invention.

FIG. 2 is a cross-sectional view illustrating the catheter and connector of the ablation apparatus shown in FIG. 1. FIG.

3 is a perspective view of the connector described in FIG.

4 is a perspective view of a needle electrode associated with the ablation apparatus described in FIG. 1.

5 is a perspective view of a flexible needle electrode used in the method of the present invention.

FIG. 6 is a view illustrating creation of an ablation zone according to the ablation apparatus shown in FIG. 1.

7 is a cross-sectional view of the tongue with the mouth closed.

8 is a cross-sectional view of the tongue with the mouth open.

9 is a perspective view of the tongue.

10 is a perspective view of the placement of the tongue.

11 is a cross-sectional view of the tongue.

12 is a cross-sectional view of the tongue illustrating the location of the nerve tissue under the tongue and the creation of the ablation zone.

13 is a cross-sectional view of the tongue illustrating multiple ablation zones.

14 is a perspective view of the abdominal surface of the tongue.

15 is a cross-sectional view of the tongue.

16 is a block diagram illustrating an analog amplifier, an analog multiplexer, and a microprocessor used in a feedback control system.

FIG. 17 is a block diagram of a temperature / impedance feedback system that may be used to control the cooling medium flow rate through the catheter of FIG. 1.

18 is a block diagram of a temperature / impedance feedback system that may be used to control the cooling medium flow rate through the catheter of FIG. 1.

19 is a three-dimensional graph illustrating the degree of contraction of the tongue following RF ablation.

20 is a graph illustrating two-dimensional contraction of bovine tongue tissue following RF ablation.

21 is a graph illustrating the three-dimensional contraction of bobbin tongue tissue by RF ablation.

22 is a graph illustrating the volume change of the tongue following RF ablation.

The method of cosmetically remodeling and debulking the tongue, palate, soft palate, tonsils of the tongue and / or adenoids provides an ablation device that includes an electromagnetic energy source and one or more electromagnetic energy transfer electrodes coupled to the electromagnetic energy source. . At least one electrode is advanced into the interior of the tongue. Sufficient electromagnetic energy is transmitted from the electrode, debulking the part of the tongue without damaging the nerve tissue under the tongue. The electrode is then removed from the inside of the tongue. The method of treating airway disorders is accomplished by debulking the tongue without damaging the sublingual tongue. The electrodes may be introduced into the tongue from the tip of the tongue, the ventral surface, the abdomen, the tongue, along the midline of the tongue, or in some cases through the lower jaw region. The tongue is excised (debulked) without damaging the nerve tissue underneath the tongue, causing remodeling and cosmetic changes of the tongue. This is accomplished by placing the electrode significantly away from the nerve tissue underneath the tongue, so that the nerve tissue under the tongue is not damaged when delivering electromagnetic energy to the tongue. Another method of treating airway disorders is achieved by debulking the tonsils of the tongue without damaging the nerve tissue under the tongue. This method is used to treat sleep apnea.

1 and 2, a resection device 10 for cosmetically remodeling and debulking the tongue, tonsils of the tongue, palate, palate and / or adenoids will be described. The ablation device 10 may be positioned such that one or more energy transfer elements or electrodes 12 are introduced into the tongue through the tongue. The ablation apparatus 10 may include visible or invisible non-traumatic correlations, provide for injecting oxygen or anesthetics, and may inhale blood or secretions. The ablation device 10 is used to treat many different disorders in the body where gas passages are limited. One embodiment uses the electrode 12 to sleep (necrosis) the tongue, tongue tonsils and / or selected portions of the adenoids using resistive heat, RF, microwave, ultrasound, and liquid thermal sprays. Treat apnea. Preferred energy sources are RF sources. In this regard, the ablation apparatus 10 can be used to ablate a targeted mass, including but not limited to tongue, tonsil, nasal bone, soft tissue, hard tissue, and mucosal tissue. In one embodiment, ablation apparatus 10 is used to debulke the tongue to increase the cross-sectional area of the airway. The disinfection medium introduction member introduces a disinfection medium in the oral cavity to reduce infection of the excised body member.

Prior to debulking the tongue, preoperative assessments including physical examination, fiberoptic pharyngoscopy, head measurement analysis, and polygraph monitoring are performed. Physical investigations emphasize the assessment of the head and neck. In addition, the nasal cavity is closely examined to identify disordered malformations of the diaphragm and nasal bone, oral pharyngeal obstruction from long and unnecessary palatal or enlarged tonsils, and hypopharyngeal obstruction from a prominent base of the tongue.

The debulking device 10 includes a catheter 14, an optional handle 16, and a different port 18 formed along the longitudinal surface of the catheter 14 or one extending from the distal end of the electrode 12. The above electrode 12 is included. The catheter 14 may be a handpiece. Advancing element 20 is provided. The battery element 20 may include a guide track or tube 23 located inside the catheter 14. The electrode 12 is located in the guide track 23 and can be advanced from the guide track into the interior of the tongue.

The ablation or debulking device 10 is connected to the catheter 14, the optional handle 16, and to different ports 18 formed along the longitudinal surface of the catheter 14, or to the distal end of the ablation source delivery element 12. One or more ablation source delivery elements 12 extending therefrom. The catheter 14 may be a handpiece. An ablation source transfer element advance element 20 known as advance element 20 may be provided. The ablation source delivery element 20 includes a guide track or tube 23 located inside the catheter 14. The ablation source delivery element 12 may be located in the guide track 23 and advanced from the guide track into the tongue. The cabling is coupled to the ablation source delivery element 12.

The ablation source delivery element 12 may be located at least partially inside the catheter 14. In one embodiment, the ablation source delivery element 12 is advanced and retracted through a port 18 formed in the outer surface of the catheter 14. The ablation source delivery element forward and contraction element 20 advances the ablation source delivery element 12 from the catheter 14 into the interior of the body structure and also causes the ablation source delivery element 12 to contract. Can be. Although the body structure may be any number of different structures, the body structure is hereinafter referred to as the tongue. The ablation source delivery element 12 cuts out the outer surface of the tongue and is directed to the inner region of the tongue. Sufficient ablation energy is delivered by the ablation source 12 into the interior of the tongue, causing the tongue to be significantly ablation and debulk. The ablation source delivery element 12 may be a hollow structure, which is suitable for (i) performing different chemistries to the selected tongue internal ablation site (for chemical ablation), and (ii) salt, chemical Alcohols or other liquids or semi-liquids are delivered to effect ablation as well as a variety of different injection media including but not limited to therapies and the like. Different physiotherapy may be combined to achieve desirable ablation, including but not limited to RF and chemotherapy, chemistry and chemotherapy. The ablation source delivery element 12 may have a limited travel distance within the tongue. In one embodiment according to the RF electrode, this is achieved by an insulating sleeve in a way that surrounds the outside of the electrode. Other devices may include structures located on ablation source delivery element 12 that limit advancement, or structures coupled to the catheter that restrict the advancement of ablation source delivery element 12, such as stop lights. One suitable fluid is an electrolyte solution. Instead of making direct contact with the electrode 12 and tissue for thermal energy transfer, a cold electrolyte solution can be used to transfer thermal energy to the tissue. The electrolyte solution may be cooled in the range of about 30 degrees Celsius to 55 degrees Celsius.

The catheter 14 includes a catheter tissue interface surface 22, a cooling medium inlet tube 24 extending through the interior of the catheter 14, and a cooling medium outlet tube 26. The port 18 is formed outside the catheter 14 and is preferably formed on the catheter tissue interface surface 22. The port 18 is insulated from the cooling medium flowing in the inlet and outlet tubes 24 and 26. The cooling medium inlet and outlet tubes 24 and 26 are configured to provide a cooling of the catheter tissue interface surface 22 of at least 1 to 2 cm ² . More preferably, the cooling portion of the catheter tissue interface surface 22 is at least equal to the cross-sectional diameter of the subregion of ablation.

In one embodiment, the cooling portion of the catheter tissue interface surface 22 is at least equal to the cross-sectional diameter of the subregion of ablation. In other embodiments, the cooling of the catheter tissue interface surface 22 only cools to the area associated with each developed ablation source delivery element.

The size of the cooling portion of the catheter tissue interface surface 22 varies with each patient. This size minimizes tongue flatness following the transfer of electromagnetic energy. The degree of reduction in the PyeongChang state may be at least 50%, at least 75% and at least 90%. The amount of cooling provided allows the patient to return home immediately after performing the debulking process and eliminates the risk of asphyxiation by the tongue. By providing a sufficient level of cooling over a relatively large area, it has been found that the amount of ablation in the internal area of the tongue is enhanced. By providing a fairly large cooling of the catheter tissue interface surface 22, adenoma response is minimized.

The handle 16 is preferably made of an insulating material. The electrode 12 is made of a conductive material such as stainless steel. In addition, the electrode 12 may be comprised of a memory metal shaped like nickel titanium, commercially available from Menlo Park, Raleigh Corporation, California. In one embodiment, only the distal end of the electrode 12 is composed of memory metal shaped to affect the desired deflection. Upon introduction into the oral cavity, the catheter 14 may be advanced until the patient's gag response is initialized. The catheter is then contracted to prevent gagging of the patient. The distal end of the electrode 12 is half curved. This distal end has a geometric shape that conforms to the outside of the tongue.

In one embodiment of the invention, the catheter 14 is a handpiece. In this embodiment, the release handle 16 is not necessary. The debulking device 10 is used to treat internal areas of the tongue. The catheter 14 has a distal end sized to be located in the oral cavity. The ablation source delivery element 12 is located at least partially inside the catheter 14. The ablation source delivery element 12 includes an ablation cut surface 30. The ablation source delivery element 20 is coupled to the ablation source delivery element 12 such that the catheter 14 is adjacent to the surface of the tongue from the catheter 14, including but not limited to the distal location of the catheter 14. Is positioned to irradiate the ablation source delivery element 12 into the interior of the tongue when positioned. The ablation source delivery element 12 advances the advance distance 33 from the urinary catheter 14 of sufficient length to have an ablation energy and / or ablation effect without damaging the nerve tissue underneath the tongue or the surface of the tongue and the interior of the tongue. Treat the area.

The catheter 14 may be adapted to conform to the surface of the tongue when the selected ablation target location is selected. Capsule-sealed soft metal or quenched metal / plastic material, such as copper, may be used to form the smallest possible catheter 14. All or part of the catheter 14 may be made of an adaptable or shaped memory metal.

For various applications, it is desirable for the distal end 14 'of the catheter 14 to be skewed. This may be accomplished mechanically or with a memory metal. A steering wire or other mechanical structure may be attached to the exterior or interior of the distal end 14 '. In one embodiment, the deflection knob located on the handle 16 is activated by the surgeon to make the steering wire rigid. This causes the distal end 14 'to deflate and deflect it. Other mechanical elements can be used in place of the steering wire. Such bias may be desirable for difficult access tissue locations.

Controlled volume reduction of the tongue under feedback control is used to obtain efficient holes in the airway passages. Various different analgesics are used, including but not limited to xylocaine. Digital ultrasonic measurement systems can be used. Ultrasonic measurements quantify biological shape changes, provide ultrasonic transmission and reception, use piezoelectric transducers (crystals), and provide time for flight data.

The disinfection medium introduction member 21 can also be introduced into the oral cavity. Disinfection media can be introduced prior to, during and / or after excision. This can be delivered continuously. The oral disinfection level is selectable by the volume of the oral cavity to be sterilized. The degree of disinfection varies. Sterilize to reduce the infection medium of the excised body structure. The disinfection medium introduction member 21 may be introduced into the oral cavity before, after or during the introduction of the ablation apparatus 10. In addition, the disinfection medium introduction member 21 may be removed at another time or at the same time that the ablation apparatus 10 is removed from the oral cavity.

The disinfection medium introduction member 21 is embedded in the ablation apparatus 10 inside the urinary catheter 14 or outside of the catheter 14 and introduces the disinfectant from the disinfectant source 23 into all or selected portions of the oral cavity. It may be an introduction with lumens configured to. The disinfection medium introduction member 21 can be moved within the oral cavity to provide for disinfection of all or part of the oral cavity. To this end, the oral cavity is an internal environment in which infectious germs can be introduced into the resected tongue, soft palate, and the like. The disinfection medium introduction member 21 is located obliquely on the catheter 14 or its exterior. Optionally, the disinfection medium introduction member 21 may be an optical fiber coupled to a light energy source, including but not limited to a UV source. The optical fiber is also placed obliquely in the oral cavity. The optical fiber is configured to provide for selective disinfection of all or a portion of the oral cavity and may have various different ends to achieve this purpose.

Suitable disinfectants include peridodex, a mouthwash including 0.12% chlorhexidine glucinate (1, 1'-hexaneethylenebis {5- (p-chlorophenyl) biganide}, water, 11.6% alcohol, glosserine, PEG 40 sorbent Base-based di-D-gloconates, including, but not limited to, non-arisorate, fragrance, and calcium saccharin, FD & C Blue No. 1, are not limited thereto.

Various different disinfectants may be used including different electromagnetic wavelengths and various chemical compounds.

At least a portion of the electrode 12 is located inside the catheter 14. Each electrode 12 is advanced and retracted through a port 18 formed in the outer surface of the catheter 14. The advancing and retracting elements advance the electrode 12 from the catheter 14 into the interior of the body structure and contract into the catheter 14. The electrode 12 cuts out the outer surface of the tongue and is directed to the inner region of the tongue. Sufficient electromagnetic energy is transferred by the electrode 12 into the interior of the tongue, causing the tongue to be significantly ablationed and debulked. The electrode 12 may be a hollow portion for receiving a variety of different injection media, including but not limited to salts. The electrode 12 may be limited to the distance that can be advanced into the tongue. This is accomplished with an insulating sleeve, a structure located on the electrode 12 that limits the advance, or a structure that is coupled to the catheter that limits the advance of the electrode 12, such as a stop.

Disinfection media can be introduced before, during and / or after excision. This can be delivered continuously. The oral disinfection level is selectable by the volume of the oral cavity to be sterilized. The degree of disinfection varies. Sterilize to reduce the infection medium of the excised body structure.

An ablation transfer surface, such as the electromagnetic energy transfer surface 30 of the electrode 12, can be adjusted including an adjustable or nonadjustable insulating sleeve 32 (FIGS. 3, 4 and 5). The insulating sleeve 32 may be advanced and contracted along the outer surface of the electrode 12 to increase or decrease the length of the electromagnetic energy transfer surface 30. The insulating sleeve 32 may be made of various materials, including but not limited to nylon, polyimide, other thermoplastics, and the like. The size of the electromagnetic energy transfer surface 30 can be varied by other methods, including but not limited to, methods of creating a divided electrode having multiple electrodes that can be multiplexed and individually activated.

In FIG. 4, the ablation source delivery element 12 extends from the outer surface of the urinary catheter 14 and has a forward length 33 directed toward the interior of the tongue. Advance length 33 is suitable for positioning ablation delivery surface 30 at a suitable tissue location inside the tongue. The ablation delivery surface 30 is of sufficient length so that the ablation effect is delivered to the appropriate tissue location and the desired level of ablation is performed at the appropriate tissue location without causing damage to the nerve tissue under the tongue. Ablation delivery surface 30 is not always at the distal end of ablation source delivery element 12. Insulator 32 may also be located at the distal end of ablation source delivery element 12. In this embodiment, the ablation delivery surface 30 does not extend to the distal end of the ablation source delivery element 12. However, the ablation delivery surface 30 delivers a sufficient ablation effect to produce a desirable level of cell necrosis in the tongue at a suitable tissue location without damaging the nerve tissue under the tongue and / or damaging the surface of the tongue. do. In addition, only part or one side of one side of the ablation source delivery element 12 can be insulated. It can also be located throughout the tongue and provides an ablation source delivery element 12 adjacent to the nerve tissue beneath the tongue. Where the ablation source delivery element 12 is adjacent to the nerve tissue under the tongue, the ablation source delivery element 12 is insulated.

In one embodiment, the advance length 33 is 1.2 to 1.5 cm, and the ablation delivery surface 30 is 5 to 10 mm in length, preferably about 8 mm.

In other embodiments, the advance length 33 is insufficient to reach the nerve tissue below the tongue when introduced through any tongue surface, particularly the tongue's abdomen.

Advance element 20 is configured to advance at least a portion of each ablation source delivery element 12 to a placement position inside the tongue. Advance element 20 may also be configured to retract each ablation source delivery element 12. In the placement position, the ablation delivery surface delivers sufficient ablation energy and / or effect to reduce the volume at the proper location without damaging the surface of the tongue and / or the nerve tissue under the tongue. In one embodiment, the ablation source delivery element and the retraction element 20 with or without the guide track 23 are excised at an angle of 60 to 90 degrees, preferably about 70 degrees, relative to the longitudinal axis of the catheter 14. The source delivery element 12 is delivered from the catheter 14 to the interior of the tongue.

In some embodiments, ablation source delivery element 12 has a geometry that includes, but is not limited to, a curved configuration, which configuration includes one or more insulating surfaces that are insulated on one side with portions at ends, distal ends, etc. close to the base. The surface is configured to reduce the volume of proper tissue location without damaging the nerve tissue under the tongue. In one embodiment, ablation source delivery element 12 is introduced through a surface of any type and a portion of ablation source delivery element 12, which may be located proximal to the nerve tissue under the tongue, is provided as insulator 32. It is configured to be. As discussed above, the insulator 32 may be located at different locations of the ablation source delivery element 12.

The handle 16 includes a connector 34 coupled to the retracting and advancing element 20. Connector 34 couples electrode 12 to a power, feedback control, temperature, and / or imaging system. RF / temperature control block 36 may be included.

In one embodiment, the surgeon moves the retracting and advancing element 20 in the direction of the distal end of the connector 34. The electrode 12 may be spring loaded. As the contraction and advancement element 20 is moved back, the spring causes the selected electrode 12 to advance in the catheter 14.

One or more cables 38 couple the electrodes 12 to the electromagnetic energy source 40. Various energy sources 40 may be used in accordance with the present invention to transfer electromagnetic energy into the interior of a body structure, including but not limited to RF, microwave, ultrasound, coherent light, and heat transfer. Preferably, energy source 40 is an RF generator. When an RF energy source is used, the surgeon can activate the RF energy source 40 using a foot switch (not shown) coupled to the RF energy source 40.

One or more sensors 42 may be located on the inner or outer surface of the electrode 12, on the insulating sleeve 32, or may be individually inserted into the body structure. The sensor 42 accurately measures the temperature at the tissue location to determine (i) the extent of ablation, (ii) the amount of ablation, (iii) whether other ablation is required, and (iv) the boundary or perimeter of the ablation geometry. do. Moreover, sensor 42 ensures that undesired tissue is not destroyed or ablated.

Sensor 42 is of conventional design, including but not limited to thermistor, thermocouple, resistive wire, and the like. Suitable sensors 42 include T-type thermocouples with copper constantene, J-type, E-type, K-type, optical fiber, resistive wires, thermocouple IR detectors, and the like. Sensor 42 does not require a thermal sensor.

Sensor 42 monitors ablation by measuring temperature and / or impedance. This reduces damage to the tissue surrounding the targeted ablation site. By monitoring the temperature at various points inside the body structure, the periphery of the ablation can be identified, and when the ablation is completed can be determined. When at any time determines that sensor 42 exceeds the desired ablation temperature, a suitable feedback signal is received at energy source 40 and the amount of energy delivered is adjusted.

Ablation or debulking device 10 may include visual capabilities, including, but not limited to, a field of view, an enlarged eyepiece, optical fiber, video imaging, and the like.

In addition, ultrasonic imaging can be used to locate the electrode 12 and determine the amount of ablation. One or more ultrasonic transducers 44 may be located in or on the electrode 12, the catheter 14, or the separating element. Imaging probes may also be used inside or outside a suitable tissue location. A suitable imaging probe is Model 21362, manufactured and sold by Halit Packard. Each ultrasonic transducer 44 is coupled to an ultrasonic source (not shown).

In FIG. 6, the catheter 14 is shown to be introduced into the oral cavity, and the multiple RF electrodes 12 are advanced into the interior of the tongue, which created different ablation zones 46. Using RF, the ablation apparatus 10 can be operated in bipolar or monopolar mode. In FIG. 6, the electrode 12 is operated in bipolar mode, creating sufficient ablation zone 46 to debulk the tongue without affecting the nerve tissue underneath the tongue, creating a larger airway passage. With this debulking, the back of the tongue moves forward from the airway passages. As a result, the cross-sectional diameter of the airway passages increases.

Using RF, the ablation apparatus 10 can also be operated in monopolar mode. The groundpad may be located at a convenient location, such as under the chin. The single electrode 12 is located in the tongue to create the first ablation zone 46. The electrode 12 then contracts from the interior of the tongue, the catheter 14 is moved, and the electrode 12 is advanced from the catheter 14 to the other interior of the tongue. The second ablation zone 46 is created. This process can be completed several times to form different ablation zones inside the tongue. One or more electrodes 12 may be introduced into the tongue and operated in bipolar mode. The electrode 12 is repositioned several times inside the tongue, creating a number of connected or disconnected ablation zones 46.

7-15, various anatomical and other structures of the tongue are described. The different anatomy is as follows. The genoglossus muscle or the body of the tongue is represented as (48), the autogenous osteotomy is represented by (50), the sublingual bone is represented by (52), the hyoid bone is represented by (54), The tip of the tongue is (56), the abdominal surface of the tongue is indicated by (58), the back of the tongue is indicated by (60), the lower back of the tongue is indicated by (62), and the reflex of the bone Is represented by (64), tongue vesicle is represented by (66), palate is (68), adenoid area is (70), transverse boundary of tongue is (72), and papillary papilla is (74) , Palatal tonsil is (76), pharyngeal is (78), multiple abdominal pharyngeal tissue is (80), cecum is (82), sublingual nerve tissue is (84), tongue tongue tongue (86) to be.

Dorsal 60 is divided into anterior 2/3 and lower back 62. Its schematic is determined by the papillary papilla 74 and the cecum 82. Lower back 62 is lower abdominal surface for upper reflex and papillary 74 of bone 64. The reflex of the bone 64 is the deep portion of the surface of the tongue in contact with the epiglottis. The tongue vesicle 66 includes the tonsils of the tongue.

The catheter 14 may be introduced through the nose or mouth. The electrode 12 may be inserted into the tongue through the dorsal surface 60, the lower dorsal surface 62, the abdominal surface 58, the tip 56 of the tongue, or the autogenous osteotomy 50. In addition, an electrode is introduced into the tongue vesicle 66 and the adenoid region 70. Once the electrodes 12 are positioned, the insulating sleeve 32 can be adjusted to provide the desired electromagnetic energy transfer surface 30 for each electrode 12.

The ablation zone 46 is created without damaging the nerve tissue 84 under the tongue. This creates a larger airway passageway to treat sleep apnea.

In all instances, the creation of the ablation zone 46 as well as the positioning of the electrode 12 ensures that the nerve tissue 84 under the tongue is not ablation or damaged. The ability to swallow and speak is not diminished.

In one embodiment, the RF electrode 12 is located on the dorsal surface of the tongue. The first electrode is located 0.5 cm close to the papillary papilla. The other electrode is located 1.6 cm apart and 1 cm away from the central axis of the tongue. In one embodiment, 465 MHZ RF is applied. The temperature at the distal end of electrode 12 is about 100 degrees Celsius. The temperature at the distal end of the insulating sleeve 32 is about 60 degrees Celsius. In another embodiment, the temperature at the distal end of the insulating sleeve 32 is at least 43 degrees Celsius. RF energy may be applied briefly during pulses with low frequency RF. Accurate goal setting of the desired ablation position is achieved. One or more electrodes 12 may be used to perform three-dimensional ablation of the volume. Various ablation geometries include, but are not limited to, straight lines, polyhedrons, recrystallized shapes, symmetry, and asymmetry.

In FIGS. 16 and 17, an open or closed loop feedback system couples the sensor 42 to an energy source 40. The temperature of tissue or electrode 12 is monitored so that the output of energy 40 is adjusted. In addition, the level of disinfection in the oral cavity can be monitored. If desired, the surgeon can polymerize the closed or open loop system. The microprocessor can be embedded in a closed or open loop system to switch power on and off as well as modulate power. The closed loop system uses a microprocessor 88 to act as a controller, monitor temperature, adjust RF power, observe the results, and resupply the results to modulate the power.

Using the sensor 42 and feedback control system, tissue adjacent to the RF signal 12 can be maintained at a desired temperature for a selected time period without delay. Each RF electrode 12 is connected to a resource that generates an independent output for each RF electrode 12. The output maintains the selected energy at the RF electrode 12 for a selected length of time.

When an RF electrode is used, the current to be transmitted through the RF electrode 12 is measured by the current sensor 90. The voltage is measured by the voltage sensor 92. Impedance and power are then calculated in the power and impedance calculator 94. This value can then be displayed in the user interface and display 96. Signals indicative of power and impedance values are received by the controller 98.

The control signal is generated by the controller 98 which is proportional to the difference between the actual measured value and the desired value. The control signal is used by the power circuit 100 to adjust the appropriate amount of power output to maintain the desired power transmitted from each RF electrode 12.

In a similar manner, the temperature detected at sensor 42 provides feedback to maintain the selected power. The actual temperature is measured on the temperature measuring element 102 and displayed on the user interface and the display 96. The control signal is generated by the controller 98 which is proportional to the difference between the actual measured temperature and the desired temperature. The control signal is used by the power circuit 100 to adjust the appropriate amount of power output to maintain the desired temperature transmitted from each sensor. By embedding a multiplexer, many sensors 42 can measure current, voltage and temperature, and energy can be delivered to RF electrode 12 in a monopolar or bipolar fashion.

The controller 98 may be a digital or analog controller or a computer with software. When the controller 98 is a computer, it may include a CPU coupled via the system bus. Such systems may include keyboards, disk drives or other non-volatile memory systems, displays, and other peripherals as are known in the art. Also, program memory and data memory are coupled to the bus.

User interface and display 96 includes operator control and display. The controller 98 may be coupled to an imaging system including but not limited to ultrasound, CT scanner, X-ray, MRI, mammographic X-ray, and the like. Moreover, direct visual and tactile imaging can be used.

The outputs of the current sensor 90 and the voltage sensor 92 are used by the controller 98 to maintain the power level selected at the RF electrode 12. The amount of RF energy delivered controls the amount of power. The delivered power profile can be included in the controller 98 and the preset amount of energy to be delivered can also be profiled. Other sensors similar to sensors 90 and 92 may be used by the controller 98 for other ablation source delivery elements 12 to maintain a controllable amount of ablation energy and / or ablation fluid.

Circuitry, software, and feedback to the controller 98 to process control and maintain selected power independent of changes in voltage or current, (i) selected power, (ii) impact coefficients (on-off and watts), (iii) bipolar or monopolar energy transfer and (iv) injection medium transfer including flow rate and pressure. These process variables are controlled and varied to maintain the desired transfer of power independent of changes in voltage or current by the temperature monitored at the sensor 42.

The current sensor 90 and the voltage sensor 92 are connected to the input of the analog amplifier 104. The analog amplifier 104 may be a conventional differential amplifier circuit used as the sensor 42. The output of the analog amplifier 104 is sequentially connected to the input of the A / D converter 108 by the analog multiplexer 106. The output of the analog amplifier 104 is a voltage representing each sensed temperature. The output voltage of the digitized amplifier is supplied to the microprocessor 88 by the A / D converter 108. Microprocessor 88 is a type 68HCII available from Motorola. However, any suitable microprocessor or general purpose digital or analog computer can be used to calculate impedance or temperature.

Microprocessor 88 sequentially receives and stores digital displays of impedance and temperature. Each digital value received by the microprocessor 88 corresponds to a different temperature and impedance.

The calculated power and impedance values can be displayed on the user interface and display 96. Optional or in addition to many indications of power or impedance, the calculated impedance and power values can be compared by the microprocessor 88 to power and impedance limits. When this value exceeds a predetermined power or impedance value, a warning may be given on the user interface and display 96, and in addition, the RF energy transmission may be reduced, modified or interrupted. Control signals from the microprocessor 88 may modify the power level supplied by the energy source 40.

18 is a block diagram of a temperature / impedance feedback system that may be used to control the cooling medium flow rate through the catheter 14. Electromagnetic energy is delivered to electrode 12 by energy source 44 and applied to tissue. The monitor 110 checks the tissue impedance by the energy delivered to the tissue, and compares the measured impedance value with the set value. When the measured impedance exceeds the set value, the disable signal 112 is sent to the energy source 40 so that no more energy is delivered to the electrode 12. If the measured impedance is within an acceptable limit, energy continues to be applied to the tissue. While applying energy to the tissue, sensor 42 measures the temperature of tissue and / or electrode 12. Comparator 114 receives a signal indicative of the measured temperature and compares this value with a pre-set signal indicative of the desired temperature. Comparator 114 sends a signal to flow regulator 116, which indicates the need for a higher cooling medium flow rate when the tissue temperature is too high and the temperature will not exceed the desired temperature. In this case, the flow rate is maintained.

Example 1

The ablation apparatus 10 was used to determine the two-dimensional shrinkage of the cow. RF volume reduction was performed using a single needle electrode. Four small ultrasonic crystals were placed to form a square. Measurements were made at the control, initially post volume reduction at 15 watts with 13% volume reduction, and volume reduction at 15 watts for 4 hours with additional 4% volume reduction. A total 17% volume reduction was done.

Example 2

The ablation apparatus 10 was used to determine the three-dimensional degree of contraction of the bovine tongue. RF volume reduction was done with a single needle electrode with eight small ultrasonic crystals, creating a cube. Initially, a 16-watt application resulted in a 17% reduction in the volume of the tongue, a 25-watt volume reduction at 25 watts initially applied, and an additional 4% reduction at 25 watts after several hours. % Volume reduction was done.

Example 3

35% volume reduction was initially done in pigs in three dimensional gross with 20 watt application.

In FIG. 19, ablation volume dimensions were measured by multidimensional digital negative rational method. The average reduction in the Z direction was 20%, and the volume shrinkage was 26%. Tertiary contraction of tongue tissue by in vivo RF ablation (ablation according to 20 watts) with needles is provided in FIG. 20. The control volume before ablation is compared with the post-ablation volume.

20 illustrates the two-dimensional contraction of the tongue tissue by RF ablation according to the needle electrode. The results before and after resection are explained.

FIG. 21 graphically illustrates ablation resulting in 17% volume shrinkage of post-ablation versus control tissue at 16 watts. Ablation at 25 watts causes 25% volumetric shrinkage after ablation. Additional 4% area shrinkage was achieved after prolonged post ablation (4 hours) versus post ablation.

Figure 22 shows percent volume change after RF ablation, 16 watts, ablation at 16 watts for 20 minutes, 25 watts, ablation at 25 watts for 20 minutes, 25 watts (4 hours) and prolonged post ablation (4 after 25 watt ablation). Time).

The foregoing description of the preferred embodiment of the present invention has been provided for the purposes of illustration. It is not intended to limit the invention to the form described. Many modifications and variations are possible to those skilled in the art. It is intended that the scope of the invention only be limited by the appended claims.

Claims (65)

In the volume reduction device of the selected position inside the tongue, Handpiece, An electrode at least partially located inside the handpiece, comprising an electrode electromagnetic energy transfer surface, capable of advancing from the interior of the handpiece into the tongue, Coupled to the electrode and configured to advance the electrode to a forward distance inside the tongue, which forwards the electromagnetic energy to the selected tissue location and reduces the volume at the selected location without damaging the nerve tissue under the tongue. An electrode advancing member sufficient for the electromagnetic energy transfer surface, And a cable coupled to the electrode. The method of claim 1, The electrode is a volume reduction device, characterized in that the RF electrode. The method of claim 2, A volume reduction device further comprising an RF energy source coupled to the RF electrode. The method of claim 1, And at least a portion located inside the handpiece, the cooling element further configured to cool the surface of the tongue. The method of claim 4, wherein And a flow rate control element coupled to the cooling element and configured to control the cooling medium flow rate through the cooling element. The method of claim 1, And at least a portion further comprising an insulator positioned around the exterior of the electrode. The method of claim 6, And a sensor located at the distal end of the insulator. The method of claim 1, And a sensor located at the distal end of the electrode. The method of claim 1, The volume reduction device further comprises a sensor located outside of the handpiece. The method of claim 1, And a second sensor positioned at the distal end of the electrode and a second sensor positioned at the distal end of the insulator, wherein at least a portion of the insulator is positioned around the outside of the electrode. The method of claim 1, A volume reduction device further comprising a feedback control means, a sensor and an RF energy source coupled to the electrode. The method of claim 1, And a source of injection medium coupled to the electrode. In the volume reduction device of the selected position inside the tongue, Handpiece, An electrode at least partially located inside the handpiece, comprising an electrode electromagnetic energy transfer surface, capable of advancing from the interior of the handpiece into the tongue, Coupled to the electrode and configured to advance at least a portion of the electrode to a placement location inside the tongue, in which the electromagnetic energy transfer surface provides sufficient electromagnetic energy to reduce the volume of the selected location without damaging the nerve tissue under the tongue. An electrode forward and contraction member for transmitting the And a cable coupled to the electrode. The method of claim 13, The electrode advancement and contraction member, And a guide channel configured to receive an electrode in at least a portion of the interior of the handpiece and to guide the forward direction of the electrode from the handpiece into the tongue. The method of claim 13, The electrode is a volume reduction device, characterized in that the RF electrode. The method of claim 14, A volume reduction device further comprising an RF energy source coupled to the RF electrode. The method of claim 13, And at least a portion located inside the handpiece, the cooling element further configured to cool the surface of the tongue. The method of claim 17, And a flow rate control element coupled to the cooling element and configured to control the cooling medium flow rate through the cooling element. The method of claim 13, And at least a portion further comprising an insulator positioned around the exterior of the electrode. The method of claim 19, And a sensor located at the distal end of the insulator. The method of claim 13, And a sensor located at the distal end of the electrode. The method of claim 13, The volume reduction device further comprises a sensor located outside of the handpiece. The method of claim 13, And a second sensor positioned at the distal end of the electrode and a second sensor positioned at the distal end of the insulator, wherein at least a portion of the insulator is positioned around the outside of the electrode. The method of claim 13, A volume reduction device further comprising a feedback control means, a sensor and an RF energy source coupled to the electrode. The method of claim 13, And a source of injection medium coupled to the electrode. In the volume reduction device of the selected position inside the tongue, Handpiece, At least a portion located inside of the handpiece and including an electrode electromagnetic energy transfer surface and an electrode advancement length extending from the outside of the handpiece to the interior of the tongue, the advance length extending the electrode electromagnetic energy transfer surface at a selected location. Positioned to deliver sufficient electromagnetic energy to reduce the volume of the selected tissue location without damaging the nerve tissue under the tongue, An electrode advancement and retraction member coupled to the electrode and configured to advance and retract at least a portion of the electrode; And a cable coupled to the electrode. The method of claim 26, The electrode is a volume reduction device, characterized in that the RF electrode. The method of claim 27, A volume reduction device further comprising an RF energy source coupled to the RF electrode. The method of claim 26, And at least a portion located inside the handpiece, the cooling element further configured to cool the surface of the tongue. The method of claim 29, And a flow rate control element coupled to the cooling element and configured to control the cooling medium flow rate through the cooling element. The method of claim 26, And at least a portion further comprising an insulator positioned around the exterior of the electrode. The method of claim 31, wherein And a sensor located at the distal end of the insulator. The method of claim 26, And a sensor located at the distal end of the electrode. The method of claim 26, The volume reduction device further comprises a sensor located outside of the handpiece. The method of claim 26, And a second sensor positioned at the distal end of the electrode and a second sensor positioned at the distal end of the insulator, wherein at least a portion of the insulator is positioned around the outside of the electrode. The method of claim 26, A volume reduction device further comprising a feedback control means, a sensor and an RF energy source coupled to the electrode. The method of claim 26, And a source of injection medium coupled to the electrode. In the volume reduction device of the selected position inside the tongue, Handpiece, An electrode having a geometry that is at least partly located inside the handpiece, capable of advancing from the interior of the handpiece to the interior of the tongue, and configured to reduce the volume of the selected location without damaging the nerve tissue under the tongue, An electrode advancement and retraction member coupled to the electrode and configured to advance and retract at least a portion of the electrode; And a cable coupled to the electrode. The method of claim 38, The electrode is a volume reduction device, characterized in that the RF electrode. The method of claim 39, A volume reduction device further comprising an RF energy source coupled to the RF electrode. The method of claim 38, And at least a portion located inside the handpiece, the cooling element further configured to cool the surface of the tongue. 42. The method of claim 41 wherein And a flow rate control element coupled to the cooling element and configured to control the cooling medium flow rate through the cooling element. The method of claim 38, And at least a portion further comprising an insulator positioned around the exterior of the electrode. The method of claim 43, And a sensor located at the distal end of the insulator. The method of claim 38, And a sensor located at the distal end of the electrode. The method of claim 38, The volume reduction device further comprises a sensor located outside of the handpiece. The method of claim 38, And a second sensor positioned at the distal end of the electrode and a second sensor positioned at the distal end of the insulator, wherein at least a portion of the insulator is positioned around the outside of the electrode. The method of claim 38, A volume reduction device further comprising a feedback control means, a sensor and an RF energy source coupled to the electrode. The method of claim 38, And a source of injection medium coupled to the electrode. In the volume reduction device of the selected position inside the tongue, Handpiece, At least a portion located inside of the handpiece and including an electrode electromagnetic energy transfer surface and an electrode advancement length extending from the outside of the handpiece to the interior of the tongue, the advance length extending the electrode electromagnetic energy transfer surface at a selected location. And an electrode that delivers sufficient electromagnetic energy to position and reduce the volume of the selected tissue location without damaging the nerve tissue under the tongue. In the volume reduction device of the selected part of the tongue, Catheter means, Electrode means at least partially located inside the catheter and configured to deliver sufficient electromagnetic energy to ablate the interior of the tongue without damaging the nerve tissue under the tongue of the tongue, Electrode advance and contraction means coupled to the electrode means for advancing and contracting at least a portion of the electrode means at a selected tongue surface; And cable means coupled to the electrode means. The method of claim 51, wherein And further comprising an electromagnetic energy source means coupled to said electrode means and cable means. The method of claim 51, wherein And at least a portion located inside the catheter and further comprising cooling means configured to cool the surface of the tongue. The method of claim 53, wherein And means for controlling the cooling medium flow rate through the cooling means. The method of claim 51, wherein Volumetric reducing device, characterized in that it further comprises insulator means, at least part of which is located around the outside of the electrode means. The method of claim 55, And a sensor means located at the distal end of the insulator means. The method of claim 51, wherein And a sensor means positioned at the distal end of the electrode means. The method of claim 51, wherein And a sensor means located outside of the catheter means. The method of claim 51, wherein A first sensor means located at the distal end of the electrode means and a second sensor means located at the distal end of the insulator means, wherein the insulator means has at least a portion located around the outside of the electrode means. Reduction device. The method of claim 51, wherein Said electrode means being an RF electrode coupled to an RF generator. The method of claim 51, wherein Said electrode means being a microwave antenna coupled to a microwave source. The method of claim 51, wherein And a feedback control means coupled to said electrode means and an electromagnetic source. 63. The method of claim 62, And an ultrasonic means coupled to the feedback control means. The method of claim 51, wherein Wherein said electrode means comprises at least two RF electrodes coupled to an RF energy source. The method of claim 51, wherein And volume injection means coupled to said electrode means.