KR20000015918A - Method for ablating interior sections of the tongue - Google Patents

Abstract

As a method for reducing tongue volume, an incision agent source is provided. The incision agent source is connected to the incision agent delivery device. At least a portion of the incision agent delivery device is advanced into the interior of the tongue. A sufficient amount of incision agent is delivered from the incision agent delivery device into the interior of the tongue to reduce the volume of the tongue without damaging the sublingual nerve. The incision agent delivery device is then retracted from the interior of the tongue.

Description

Internal tongue incision

Cross Reference of Related Application

This application is a partial application of US Patent Application No. 08 / 239,658 filed on May 9, 1994 entitled "Method of Reducing Snoring by RF Incision of Neck Milk," Edward, Edward Jay. Gow and David L. Douglas, who was filed on August 18, 1995, entitled "Systems and incisions for removal of soft tissues," filed on February 23, 1996, entitled "Methods for Treating Airway Disorders." Partial continuation of US 08/606195, filed under the application, May 3, 1996 Partial continuation of US application of 08/642053, filed on May 3, 1996, filed May 22, 1996 Part of the ongoing application of US patent application Ser. No. 08 / 651,800 filed entitled " Methods and Devices for Airway Shielding ".

Sleep apnea is characterized by severe daydreaming during the day, morning arm pain, memory loss, cardiac arrhythmias, snoring and sleep during sleep. This occurs because apnea frequently intervenes during sleep of the patient. These symptoms are typically divided into two types. One type called "central sleep apnea" is characterized by repetitive loss of breathing ability. The second type, called “disability sleep apnea,” is characterized by repeated apnea during sleep by blocking part of the patient's respiratory tract, which does not include the patient's upper respiratory tract or larynx.

Treatment includes a variety of medical and internal medical procedures. Medical treatments include the use of drugs such as protriptyline, methoxyprogesterone, acetazolamide, theophylline, nicotine and other agents that do not have a central nervous system sedative effect such as alcohol or alcohol. The above medical treatment is often beneficial but difficult to expect full effect. In addition, drug administration often results in undesirable side effects.

Surgical treatments include palatal plastic surgery, tonsillectomy, surgery to correct severe mandibular condyle and tracheal fistula. In one of these procedures, the jaw is moved and pulled forward to access the base of the tongue. Although these measures are effective, the risk of surgery for these patients can be enormous and often unacceptable to the patient.

Medical treatments include weight loss, nasopharyngeal airways, nasal CPAP, and various tongue support devices used at night. Such treatment may be effective in part, but is cumbersome and inconvenient, and often the patient may not want to continue using such a device in the long term. Weight loss is also effective, but difficult to achieve by these patients.

In patients with central sleep apnea, diaphragmatic nerve or diaphragm pacing is used. Diaphragm nerve or diaphragm coordination involves the use of electrical stimulation to control and control the diaphragm of a patient that has been bilaterally stimulated by the diaphragm nerve to assist and maintain breathing. These pacings are described in J.Mugica's "Direct Diaphragm Stimulation" published in PACE Volume 10 (1987, Jan.-February), and J.Mugica et al. Preliminary Tests for: "Abstracts Nochomovitez IEEE Eng. 1985, pages 263-279 and June 1993, in Medicine and Biology. "Electrical activation of respirators".

However, it has been found that to some extent, many of these patients have obstructive sleep apnea, which is aggravated when the inspiratory force is increased by the pacer. Aeration induced by activation of the diaphragm can suffocate the patient by blocking the upper airway during inspiration and pulling the patient's tongue down the throat. For proper treatment of these patients, tracheal fistula surgery is required. The physiological laryngeal pacemaker, described by Kaneko et al. In Trans Am Soc Artif Intern Organs 1985, detects the volume replaced by the lungs, Iii) Stimulates the proper nerve to open. Such a device is not effective for the treatment of sleep apnea. These devices generate signals that are proportional to the volume of air replaced in the lungs, which is too late to be used as an indicator for treating sleep apnea. Often during sleep apnea due to blockage there may be no air volume replaced.

One effective treatment for obstructive sleep apnea is tracheal fistula surgery. However, these surgical methods result in severe mental impairment and are not aesthetically acceptable to many patients. Other surgical procedures include pulling the tongue forward as far as possible and surgically cutting to remove portions of the structure that may block the tongue and airway passages.

What is needed is a method for treating a disabled sleep apnea without major surgical intervention. There is also a need for a method that can use incision energy and / or incision agents to incite selected internal regions of the tongue without damaging the sublingual nerve.

Summary of the Invention

It is therefore an object of the present invention to provide a method of reducing the volume of a selected area inside the tongue without damaging the sublingual nerve.

Another object of the present invention is to provide a method for incision of a selected area inside the tongue without damaging the sublingual nerve by delivering an incision energy or incision agent to the selected tissue area.

These and other objects of the present invention are achieved by a method of reducing the volume of the tongue. An incision device is provided that includes an incision energy source and an incision energy delivery device. At least a portion of the incision energy delivery device is advanced into the interior of the tongue. Sufficient energy is transferred from the incision energy delivery device into the tongue to reduce the volume of some areas of the tongue without damaging the sublingual nerve. Thereafter, the incision energy delivery device retracts from inside the tongue.

In another embodiment, an incision agent source is provided. The incision agent source is connected to the incision agent delivery device. At least a portion of the incision agent delivery device proceeds inside the tongue. A sufficient amount of incision agent is delivered from the incision agent delivery device into the tongue to reduce the volume of a portion of the tongue without damaging the sublingual nerve. Thereafter, the incision agent delivery device retracts from inside the tongue.

The present invention relates to a method for treating airway shielding, and more particularly to a method for incision of selected tissue regions within the tongue without damaging the sublingual nerve using incision energy and / or incision agents.

1 is a cross-sectional view of a volume reduction device used in the method of the present invention.

FIG. 2 is a cross-sectional view showing the connector and catheter of the volume reduction device shown in FIG. 1.

3 is a perspective view of the connector shown in FIG. 1.

4 is a perspective view of the incision source delivery device associated with the volume reduction device shown in FIG.

5 is a perspective view of a flexible incision source delivery device used in the method of the present invention.

FIG. 6 shows the incidence of incisions by the volume reduction device 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 dorsum of the tongue.

11 is a cross-sectional view of the tongue.

12 is a cross-sectional view of the tongue showing the location of hypoglossal nerves and the development of incisions.

13 is a cross-sectional view of the tongue showing a plurality of incisions.

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

15 is a cross-sectional view of the tongue.

Figure 16 is a block diagram of a feedback control system for use in the method of the present invention.

FIG. 17 is a block diagram illustrating an analog amplifier, an analog multiplexer, and a microprocessor used in the feedback control system of FIG. 17.

FIG. 18 is a block diagram of a temperature / impedance feedback system used to control the flow rate of conductive material through the catheter of FIG. 1.

19 is a three-dimensional graph showing the percentage reduction of the tongue by RF (high frequency) incision.

20 is a graph showing the two-dimensional reduction of the tongue tongue tissue by RF incision.

FIG. 21 is a graph showing three-dimensional reduction of the tongue tongue tissue by RF incision.

22 is a graph showing the percentage volume change of the tongue by RF incision.

1 and 2 show a volume reducing device 10 that reduces the volume of selected tissue regions, including but not limited to tongues, tongue tonsils, and / or throats, and generates controlled cell necrosis. Is shown. The volume reduction device 10 may be positioned such that one or more incision source delivery devices 12 comprising devices for delivering incision energy and / or incision agents may deliver incision energy and / or incision agents to selected tissue areas. The incision energy and incision agent may be incisions, alcohol incisions, diode laser incisions, laser fiber (removal) incisions, chemotherapy associated with incisions, microwave (915 MHz to 2.45 GHz), ultrasound, high temperature or very low temperature solutions. A thermal or cryogenic incision, a solid or gas delivered by injection through a needle or the like, may be provided with a chemical incision with various other features or mixtures to generate RF in all wavelength bands. Each incision source delivery device 12 is inserted into the tongue through the surface of the tongue. The volume reduction device 10 may include a non-traumatic intubation method with or without visualization that can supply oxygen or anesthetics and inhale blood or secretions. It is anticipated that this volume reduction device 10 can be used to treat various other disorders on the body where gas passages are restricted. An embodiment is an incision source delivery device for incision of tongue, tongue tongue and / or selected portions of adenoids (cell necrosis) using resistive heat, RF, microwaves, ultrasound, and liquid thermal jets. It is the treatment of sleep apnea using. Preferred energy sources are RF sources. In this regard, volume reduction device 10 can be used to incise selected tissues including but not limited to tongue, tonsil, turbinate, soft palate, hard tissue and mucosal tissue. In one embodiment, volume reduction device 10 may be used to reduce the volume of the tongue to increase the cross-sectional area of the air passage. The disinfectant insert inserts the disinfectant into the oral cavity to reduce infection of the incised body parts.

Prior to reducing the volume of the tongue, prior surgical evaluations including medical examination, fiber optic pharynx, head measurement analysis and radiography monitor are performed. Medical examination is important for the evaluation of the head and neck. In addition, disturbing deformation of the septum and cuff; Oropharyngeal disorder caused by long, excessive soft palate or hypertrophic tonsils; Detailed examination of the nasal cavity is included to identify the hypopharyngeal disorder caused by the protruding bottom of the tongue.

Volume reduction device 10 includes a catheter 14, selection knob 16 and another port 18 formed along the longitudinal surface of catheter 14, or one or more incision source delivery devices 12 extending from the distal source delivery device end. do. Catheter 14 may be adapted to be held by hand. Advance device 20 may be provided. Advancement device 20 may include a guide track or tube 23 located inside catheter 14. The incision source delivery device 12 may be located within the guide track and travel from the guide track into the tongue. The cable is connected to the incision source delivery device 12.

The volume reduction of the controlled tongue under feedback control is used to create an effective opening in the airway path. Various pain relief agents can be used, including but not limited to, lidocaine. Digital ultrasonic measuring systems can be used. Ultrasonic measurements measure the amount of biological shape change, send and receive ultrasound, use piezoelectric transducers (crystals), and provide time for flight data.

A disinfectant insert 21 is included and inserted into the oral cavity. The disinfectant insert 21 may be inserted before or after the volume reduction device 10 is introduced into the oral cavity. In addition, the disinfectant insert 21 may be removed at the same or different time when the volume reduction device 10 is removed from the oral cavity. The disinfectant insertion member 21 may be included in the volume reduction device 10 inside the catheter 14 or outside the catheter 14, and the lumen may be inserted into the whole or selected portion of the disinfectant source 23 from the disinfectant source 23. It may be an introducer having a lumen. The disinfectant insert 21 may move within the oral cavity to provide disinfection to the entire or only a portion of the oral cavity. For this purpose, the oral cavity is the internal environment in which the infecting bacteria can penetrate into the incision tongue, soft palate, and the like. The disinfectant insert 21 is slidably positioned inside or outside the catheter 14. Also optionally, the disinfectant insert 21 may be an optical fiber coupled with a light energy source, including but not limited to a UV source. The optical fiber may also be slidably positioned in the oral cavity. The optical fiber is shaped to provide selective disinfection of all or part of the oral cavity and may have a variety of different ends to achieve this purpose.

Suitable disinfectants include Peridex, 0.12% chlorohexidine glusinate {1,1'-hexaneethylenebis [5- (p-chlorophenyl) biganide} di-D-gluconate, 11.6% alcohol in base-containing aqueous solution. , Glycerin, PEG 40 sorbitan arsenite, flavoring agents, calcium saccharin and FD & C Blue No. 1

It is anticipated that various disinfectants with different electromagnetic wavelengths and different chemical components may be used. The disinfectant may be inserted before, during and / or after incision. Disinfectants can be delivered continuously. The degree of disinfection of the oral cavity may be selected according to the volume of the oral cavity to be disinfected. The degree of disinfection varies. Disinfection is provided to reduce infection of the incised structure.

The incision source delivery device 12 is at least partially located within the catheter 14. In one embodiment, the incision source delivery device 12 proceeds and contracts through port 18 formed on the outer surface of the catheter 14. The incision source delivery and contraction device 20 may advance the incision source delivery device 12 from the catheter 14 into the body tissue and constrict the incision source delivery device 12 from within the body tissue. The body tissue may be any number of other tissues, but the body tissue below is assumed to be the tongue. The incision source delivery device 12 penetrates through the outer surface of the tongue to the inner region of the tongue. Sufficient incision energy is delivered to the interior of the tongue by the incision source 12 so that the tongue is sufficiently incised and the volume is reduced. The incision source delivery device 12 is suitable for (i) delivery of various chemicals to the internal incision area of the tongue (for chemical incisions), and (ii) a variety of infusions, including but not limited to saline, chemotherapeutic agents, and the like. Rather, it may be a hollow structure for delivering alcohol or other liquids or semi-liquids to achieve incisions. Other modalities may be combined to achieve the necessary incisions, including but not limited to RF and chemotherapy, chemicals, and chemotherapy. The incision source delivery device 12 has a limited tongue internal travel distance. In embodiments involving an RF electrode, this is achieved by an insulating sleeve in a relationship surrounding the outside of the electrode. The other device may include a structure located on the incision source delivery device 12 to limit its progression, such as a stop, or a structure connected to a catheter to limit the progression of the incision source delivery device 12. .

Incision source delivery device 12 may include a plurality of fluid delivery ports as well as a central lumen for receiving various fluids that may be inserted into the interior of the tongue. In one embodiment, the disinfectant may be introduced into the selected body tissue through the incision source delivery device 12. One suitable liquid is an electrolyte solution. Instead of directly contacting the tissue and incision source delivery device 12 for thermal energy transfer, a cooled electrolyte may be used to transfer thermal energy into the tissue. The electrolyte is cooled in the range of 30 to 55 ° C.

Catheter 14 includes a catheter tissue interface 22, a refrigerant inlet conduit 24, and a refrigerant outlet conduit 26 extending through the interior of the catheter 14. Port 18 is formed outside of catheter 14, preferably on catheter tissue interface 22. Port 18 is insulated from refrigerant flowing through inlet and outlet conduits 24 and 26. The refrigerant inlet and outlet conduits 24 and 26 provide a cooled portion of the catheter tissue interface 22 having an area of at least 1 to 2 cm ² . More preferably, the cooled portion of the catheter tissue interface 22 is at least equal to the cross-sectional diameter covering the incision area. In other embodiments, the cooled region of the catheter tissue interface 22 only provides cooling to the area associated with each expanded incision source delivery device.

The size of the cooled portion of the catheter tissue interface 22 is different for each patient. It is of sufficient size to minimize swelling of the tongue by the transfer of electromagnetic energy. The reduction in swelling can be at least 50% or at least 75% and at least 90%. The amount of cooling provided is such that the patient can return home immediately after volume reduction surgery is performed and there is no risk of choking. It can be seen that by providing a sufficient amount of cooling over a relatively large area, the amount of incision inside the tongue is increased. By sufficiently increasing the cooled portion of the catheter tissue interface 22, the adenoma reaction is minimized.

By including an adjustable or non-adjustable insulation sleeve 32 (FIGS. 3, 4 and 5), the incision delivery surface 30 of the incision source delivery device 12 can be adjusted. The insulating sleeve 32 may be advanced or retracted along the outer surface of the incision source delivery device 12 to increase or decrease the length of the incision delivery surface 30. Insulation sleeve 32 is made of various materials including, but not limited to, nylon, polyamide, other thermoplastics, and the like. The size of the incision delivery surface 30 can be varied in various ways, such as by creating a divided incision source delivery device having a plurality of incision source delivery devices capable of multiplexing and individually operating.

With particular reference to FIG. 4, the incision source delivery device 12 extends from the outer surface of the catheter 14 and has a forward length 33 towards the interior of the tongue. Advance length 33 is sufficient to position incision delivery surface 30 in the tongue and select tissue. By having a sufficient length of the incision delivery surface 30, the incision energy is transferred to the selected tissue region, and it is possible to generate the necessary degree of incision (cell degeneration) in the selected tissue region without causing damage to the sublingual tongue. The incision delivery surface 30 need not necessarily be the end of the incision source delivery device 12. Insulator 32 may also be located at the distal end of the incision source delivery device 12. In this embodiment, the incision delivery surface 30 does not extend to the distal end of the incision source delivery device 12. However, the incision delivery device 30 still delivers enough incision energy to form the necessary amount of cell necrosis in the selected tissue region without damaging the sublingual tongue and / or damaging the tongue surface. In addition, only one side or a portion of one side of the incision source delivery device may be insulated. It may also be provided for an incision source delivery device 12 that may be located throughout the tongue, including the sublingual tongue proximal portion. If the incision source delivery device 12 is adjacent to the sublingual nerve, the incision source delivery device 12 is insulated.

In one embodiment, the advancing length 33 is between 1.2 cm and 1.5 cm and the incision delivery surface 30 is between 5 and 10 mm, more preferably about 8 mm.

In another embodiment, the forward length 33 is not sufficient to reach the sublingual tongue when inserted through any part of the surface of the tongue, particularly through the dorsum of the tongue.

The incision source delivery device forward device 20 is shaped to allow at least a portion of each incision source delivery device 12 to advance to a specific location within the tongue. The incision source delivery device forward 20 is also shaped to retract each of the incision source delivery devices 12. In certain locations, the incision delivery surface delivers sufficient incision energy and / or effect to reduce the volume of the selection without damaging the sublingual tongue and / or tongue surface. In one embodiment, the incision source delivery device forward and retractor 20 with or without a guide track is inserted into the tongue from catheter 14 at an angle of 60 to 90 °, preferably about 70 °, relative to the longitudinal axis of catheter 14. Orient the delivery of the incision source delivery device 12.

In some embodiments, the incision source delivery device 12 has a geometry including but not limited to a curved shape that is shaped to reduce the volume of the selected tissue region without damaging the sublingual nerve. The curved shape has one or more insulating surfaces with one side partially insulated at the end, proximal end, and the like. In one embodiment, the incision source delivery device 12 is shaped to include an insulator 32 in the region of the incision source delivery device 12 that is inserted through the surface of any tongue and located close to the sublingual tongue. As noted above, insulator 32 may be located in another region of the incision source delivery device 12.

Handle 16 is preferably made of insulating material. The incision source delivery device 12 is made of a conductive material such as stainless steel. The incision source delivery device 12 may also be made of shape memory metal such as nickel-titanium commercially available from Raychem Corporation of Menlo Park, California. In one embodiment, only the distal end of the incision source delivery device 12 may be made of shape memory metal to bend to a desired degree. When inserted into the mouth, catheter 14 may advance until the patient's vomiting reaction. Catheter 14 retreats to prevent the patient from vomiting. The distal end of the incision source delivery device 12 may be hemispherical. The distal end may have a geometry that fits outside the tongue.

In one embodiment of the present invention, the catheter 14 is hand held, and for the purposes of the present invention, the catheter 14 is referred to as "handpiece 14." In this embodiment, no separate handle 16 is needed. The volume reduction device 10 is used to treat the internal area of the tongue. Handpiece 14 has a distal end sized to be placed in the oral cavity. The incision source delivery device 12 is at least partially located inside the handpiece 14. Incision source delivery device 12 has an incision delivery surface 30. When the incision source delivery device 20 is connected to the incision source delivery device 12 and the handpiece 20 is positioned adjacent to the surface of the tongue, an incision into the tongue from the handpiece 20 including but not limited to the end of the handpiece 20. A scale is set for advancing the source delivery device 12. The incision source delivery device 12 advances by 33 travel distances from the handpiece 20 of sufficient length to treat the internal area of the tongue as an incision energy and / or incision without damaging the surface of the tongue or the sublingual tongue.

Catheter 14 is malleable to suit the surface of the tongue when a selective incision target is selected. Light metals, such as encapsulated copper, or annealed metal / plastic materials may be used to form the annealable catheter 14. All or part of catheter 14 may be workable or may be made of shape memory metal.

In many applications, it is desirable for the terminal 14 'of the catheter 14 to bend. This can be accomplished mechanically or by using a memory metal. A regulating wire, or other mechanical structure, can be attached to either the inside or the outside of the end 14 '. In one embodiment, the tension knob on the handle 16 can be moved by pulling the adjustment wire taut. This allows for the retraction of the end 14 'and consequently bowing. It is anticipated that other machinery may be used instead of the regulating wire. Deflection is useful for accessing various organizational areas.

The handle 6 includes a connector 34 connected to the retracting and advancing device 20. Connector 34 connects the incision source delivery device to the power, feedback controller, temperature and / or imaging system. RF / temperature control block 36 may also be included.

In one embodiment, the surgeon moves the retraction and advancement device 20 toward the distal end of the connector 34. The incision source delivery device 12 may be spring loaded. As the retraction and advancement device 20 moves back, the spring causes the selected incision source delivery device 12 to advance from the catheter 14.

One or more cables 38 connect the incision source delivery device 12 to the electromagnetic energy source 40. The present invention includes, but is not limited to, RF, microwave, ultrasound, interference light, non-interfering light, ultrasound, chemical dissection, alcohol dissection, heat transfer, heat jet, chemotherapy combined with RF, and other combinations of these sources. Various energy sources 40 can be used to transfer electromagnetic energy into the body. Preferably, energy source 40 is an RF generator. When an RF energy source is used, a physician may operate the RF energy source 40 using a foot switch (not shown) connected to the RF energy source 40.

One or more sensors 42 may be located on the interior and exterior surfaces of the incision source delivery device 12, insulation sleeve 32, or may be inserted independently into the body structure. The sensor 42 measures the precise temperature of the tissue area to determine (i) the extent of the incision, (ii) the amount of incision, (iii) whether additional incision is needed, and (iv) the boundary or periphery of the incision geometry. To make it possible. In addition, sensor 42 prevents the undesired tissue from being destroyed or incised.

Sensor 42 is of conventional design, including but not limited to thermistor, thermocouple, resistance wire, and the like. Suitable sensors 42 include T-type thermocouples with copper constantene, J-type, E-type, K-type, fiber optics, resistance wires, thermocouple IR detectors, and the like. It is expected that sensor 42 need not be a thermal sensor.

Sensor 42 measures temperature and / or impedance to enable an incision monitor. This reduces damage to the tissue surrounding the targeted incision mass. By monitoring the temperature at various points inside the body tissue, the outer periphery of the incision can be identified and can determine when the incision is complete. When the sensor 42 determines that the desired incision temperature has been exceeded, an appropriate feedback signal is received at the energy source 40 and the amount of energy delivered is adjusted.

The volume reduction device 10 has visualization capabilities including, but not limited to, viewing scopes, extended eyepieces, fiber optics, video imaging, and the like.

Ultrasound imaging may also be used to determine the location of the incision source delivery device 12 and / or the amount of incision. One or more ultrasound transducers 44 may be located on or outside the incision source delivery device 12, catheter 14, or on each device. Imaging probes can be used internally and externally to selected tissue regions. A suitable imaging probe is Model 21362, manufactured and sold by Hewlett-Packard. Each ultrasonic transducer 44 is connected to an ultrasonic source (not shown).

In FIG. 6, a catheter 14 inserted into the oral cavity is shown, and the multiple RF incision source delivery device 12 is advanced into the tongue, forming various incision zones 46. Using RF, volume reduction device 10 can be operated in bipolar or unipolar mode. In Figure 6, the incision source delivery device is an RF electrode operating in bipolar mode, which reduces the volume of the tongue without affecting the sublingual tongue and forms an incision zone 46 sufficient to expand the airway passages. This volume reduction causes the back of the tongue to move away from the air passages. As a result, the cross-sectional diameter of the air passage increases.

Using RF, volume reduction device 10 can also operate in monopolar mode. The groundpad may be located at a convenient point, such as under the chin. A single RF electrode 12 is placed inside the tongue to form the first incision zone. RF electrode 12 retracts from inside the tongue, and catheter 14 moves, then RF electrode 12 advances from catheter 14 to another internal region of the tongue. A second incision zone 46 is formed. This process can be repeated several times to form various incision zones inside the tongue.

One or more incision source delivery devices 12 may be inserted into the tongue and operated in bipolar mode. One or more incision source delivery devices 12 may be repositioned several times within the tongue to form a plurality of connected or separated incision zones 46.

In Figures 7-15, anatomy of the tongue or other tissue is shown. The various anatomical structures are as follows: the body of the sublingual muscle or tongue is labeled 48; Metatarsal muscle is 50; Posterior hyoid bone 52; Hyoid bone is 54; The tip of the tongue is 56; The tongue's mask was 58; The dorsum of the tongue is 60; The lower back of the tongue is 62; The shadow of the vallecula is 64; Sulfofoam is 66; Wet 68; Adenoids are 70; The transverse boundary of the tongue is 72; Papillary papilla is 74; Palate is 76; Pharynx 78; The remaining pharyngeal tissues are 80; Snow blindness is 82; Sublingual tongue is 84; The novel platoon of tongues is 86.

Dorm 60 is divided into anterior two thirds and lower back 62. The contour is determined by the papillary papilla 74 and the snowman 82. Lower back 62 is lower lower back than upper shadow of papillary papilla 74 and vallecula 64. The shadow of the vallecula (64) is the deepest part of the tongue extension, continuous with the epiglottis. Sulfoforum 66 includes palate tonsils.

Catheter 14 may be inserted through the nose or the oral cavity. The incision source delivery device 12 may be inserted into the tongue through the dorsal surface 60, the lower back 62, the wall 58, the tongue tip 56, or the ear bone muscle 50. In addition, the incision source delivery device 12 may be inserted into the sulfophore 66 and into the adenoid region 70. Once the incision source delivery device 12 is in place, the insulating sleeve 32 is adjusted to provide the energy transfer surface 30 required for each incision source delivery device 12.

An incision 46 is formed without damaging the sublingual tongue 84. This creates a larger airway passage and enables treatment for sleep apnea.

In all cases, the location of the incision source delivery device 12 and the location of the incision zone 46 are determined so that the sublingual nerve 84 is not damaged or incised. Chewing and speaking are not impaired.

Figure 16 shows the incision source delivery device located on the back surface 60 of the tongue. The first electrode is located about 0.5 cm near the papillary papilla. The other electrode is 1.6 cm away and 1 cm away from the central axis of the tongue. In one embodiment, 465 MHz RF is applied. The temperature at the end of the incision source delivery device 12 is about 100 ° C. The temperature at the 32 ends of the insulating sleeve is about 60 ° C. In another embodiment, the terminal temperature of insulation sleeve 32 is at least about 43 ° C. RF energy may be applied as a short period pulse having a low frequency RF. Accurate positioning of the required incision is achieved. One or more incision source delivery devices 12 may be used to achieve a three-dimensional volume of incision. Various incision geometries are possible, including, but not limited to, straight, polyhedral, recrystallized, symmetrical and asymmetrical.

In FIGS. 17 and 18, an open or closed loop feedback system connects sensor 42 to energy source 40. The temperature of the tissue or incision source delivery device 12 is monitored and the output power of the energy source 40 is adjusted accordingly. In addition, the degree of disinfection in the oral cavity is monitored. If necessary, the surgeon may ignore the closed or open loop system. In addition to regulating power, microprocessors can be included in closed or open loop systems to power on and off. The closed loop system utilizes a microprocessor 88 that functions as a controller, monitoring temperature, adjusting RF power, reviewing results, refeeding results, and adjusting power.

By using the sensor 42 and the feedback control system, tissue adjacent to the incision source delivery device 12 can be maintained at a desired temperature for a predetermined period of time without being impeded out. Each incision source delivery device 20 is coupled to a resource generating an independent output of each of the incision source delivery devices. The output maintains the selected energy in the incision source delivery device 12 for a predetermined time.

When an RF electrode is used, the current delivered through the RF electrode is measured by the current sensor 90. The voltage is measured by voltage sensor 92. Impedance and power are calculated by the power and impedance calculator 94. These values can be displayed in the user interface and display 96. Signals indicative of power and impedance are received at controller 98. Signals representing energy transfer for other energy sources may also be generated, measured, and received at controller 98.

The control signal is generated in controller 98 in proportion to the difference between the actually measured value and the required value. The control signal is used in a power circuit 100 that adjusts the power output to an appropriate amount to maintain a predetermined transfer power in each incision source delivery device 12.

In a similar manner, the temperature detected at sensor 42 provides feedback for maintaining the selected power. The actual temperature is measured on the temperature measuring device 102 and displayed on the user interface and the display 96. The control signal is generated in controller 98 in proportion to the difference between the actually measured temperature and the required temperature. The control signal is used in the power circuit 100 to adjust the power output to an appropriate amount to maintain the transfer temperature required for each sensor. A multiplexer may be included to measure current, voltage and temperature in the plurality of sensors 42.

Controller 98 may be a digital or analog controller, or a computer having software. If the controller 98 is a computer, it may include a CPU connected via a system bus. Such systems may include keyboards, disk drivers, or other nonvolatile memory systems, displays, and other peripherals known in the art. Program memory and data memory may also be coupled to the bus.

User interface and display 96 includes operator controls and displays. The controller 98 may be connected to an imaging system, including but not limited to ultrasound, CT scanner, X-rays, MRI, mammograms, x-rays, and the like. In addition, direct visualization and contact imaging can be used.

The outputs of current sensor 90 and voltage sensor 92 are used in controller 98 to maintain a predetermined power level at RF electrode 12. The amount of RF energy delivered controls the amount of power. A profile of the delivered power may be included in the controller 98 and the predetermined amount of energy to be delivered is also profiled. Other sensors similar to sensors 90 and 92 are used in controller 98 so that other incision source delivery devices 12 maintain controllable amount of incision energy and / or incision agent.

Feedback to circuitry, software, and controller 98 controls the process and maintains selected power regardless of changes in current or voltage, (i) selected power, (ii) duty cycle (on-off and watts), (iii) Or bipolar energy transfer and (iv) varying injection material transfer including flow rate and pressure. Based on the temperature or other suitable variable monitored at the sensor 42, these process variables are controlled and changed while maintaining the required transfer power regardless of the change in voltage or current.

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

Microprocessor 88 continuously receives and stores digital representations of impedance and temperature. Each digital value received by microprocessor 88 corresponds to a different temperature and impedance.

The calculated impedance and power value may be displayed on the user interface and the display 96. Alternatively, or in addition to numerical representations of power and impedance, the calculated impedance and power values can be compared by the microprocessor 88 to the power and impedance limits. If the value exceeds a predetermined impedance and power value, a warning may be given on the user interface and display 96, and the RF energy transfer may be reduced, changed, or interrupted. Control signals from microprocessor 88 may alter the power level supplied by energy source 40.

18 shows a block diagram of a temperature / impedance feedback system that can be used to control the refrigerant flow rate through catheter 14. Energy is delivered to the incision source delivery device 12 by energy source 44 and applied to the tissue. The monitor 110 checks the tissue impedance based on the energy delivered to the tissue and compares the measured impedance value with the set point. If the measured impedance exceeds the set value, the inoperable signal 112 is transmitted to the energy source 40 and stops transmitting additional energy to the incision source delivery device 12. If the measured impedance, or other variable, is within an acceptable range, energy continues to be applied to the tissue. While energy is applied to the tissue, sensor 42 measures the temperature of the tissue and / or incision source delivery device 12. Comparator 114 receives a signal indicative of the measured temperature and compares it with a preset signal indicative of the required temperature. If the temperature of the tissue is too high, the comparator 114 sends a signal to the flow regulator 116 indicating that a high refrigerant flow rate is needed, and maintains the flow rate if the temperature does not exceed the required temperature.

Example 1

The volume reduction device 10 is used to determine the two-dimensional contraction of the bovine. RF volume reduction was achieved by using a single needle electrode. Four small ultrasonic crystals were placed to form a rectangle. Measurements were performed under control, with an initial volume loss of 13% at 15 W and an additional volume reduction of 4 over 4 hours. A total of 17% volume change was achieved.

Example 2

The volume reduction device 10 is used to determine the three-dimensional contraction of the tongue. RF volume reduction was achieved by using a single needle electrode with eight small ultrasonic crystals to form a cube. The 16 W application initially provided a 17% reduction in volume of the tongue, the 25 W application initially provided a 25% reduction in volume of the tongue, and a few hours later 25 W provided an additional reduction of 4%. The decrease is 29%.

Example 3

In the initial application of 20 W, a 35% reduction in volume was achieved under the in vivo conditions of pigs as a three-dimensional total.

Referring to FIG. 19, the incision volume size was measured by a multidimensional digital sonomicrometer. The average decrease in the Z direction was 20% and the volumetric shrinkage was 26%. A three-dimensional contraction of the tongue tissue in vivo by RF incision with a needle (incision as 20W) is shown in FIG. 20. The control volume before incision is compared with the volume after incision.

20 shows two-dimensional contraction of the tongue tongue tissue by RF incision with needle electrode. The results before and after incision are shown.

FIG. 21 graphically depicts the incision at 16W with 17% tissue volume loss in control versus incision. The incision at 25W results in a 25% volume reduction after the incision. An additional 4% area contraction is obtained when comparing the incision after a long time (4 hours) after the incision.

22 shows the percentage of volume change after RF incision. Incision for 20 minutes at 16 W, 16 W; 20 min incision at 25 W, 25 W; 25 W (4 hours), and long time after incision (4 hours after 25 W incision).

The foregoing description of the preferred embodiment of the present invention is shown illustratively and descriptively. The present invention is not limited to the specific forms disclosed. Various modifications and variations will be apparent to those skilled in the art. It is intended that the scope of the invention be defined by the following claims and their equivalents.

Claims (20)

Providing an incision device comprising an incision energy source and an incision energy delivery device; Advancing at least a portion of the incision energy delivery device into the tongue; Delivering a sufficient amount of energy from the incision energy delivery device to the interior of the tongue to reduce the volume of the tongue without damaging the sublingual nerve; And, And retracting the incision energy delivery device from the interior of the tongue. The method of claim 1, The energy source is an RF source, the incision energy delivery device tongue volume reduction method, characterized in that the RF electrode. The method of claim 1, The energy source is an interference source of light, the incision energy transfer device is a tongue volume reduction method, characterized in that the optical fiber. The method of claim 1, Wherein said energy source is a heated fluid and said incision energy delivery device is a catheter having a closed channel for receiving said heated fluid. The method of claim 1, Wherein said energy source is a heated fluid and said incision energy delivery device is a catheter having an open channel for receiving said heated fluid. The method of claim 1, Wherein said energy source is a cooled fluid and said incision energy delivery device is a catheter having a closed channel for receiving said cooled fluid. The method of claim 1, Wherein said energy source is a cooled fluid and said incision energy delivery device is a catheter having an open channel for receiving said heated fluid. The method of claim 1, And said energy source is a cryogenic fluid. The method of claim 1, The energy source is a microwave source providing energy of 915MHz to 2.45GHz, the incision energy transfer device is a tongue antenna, characterized in that the microwave antenna. The method of claim 1, The energy source is an ultrasonic source, the incision energy delivery device is a tongue volume reduction method, characterized in that the ultrasonic emitter (emitter). The method of claim 1, The energy source is a tongue source reduction method, characterized in that the microwave source. The method of claim 1, And the electrode is advanced through the ventral surface of the tongue into the interior of the tongue. The method of claim 1, And the electrode is advanced into the tongue through an inferior dorsal surface of the tongue. The method of claim 1, And the electrode is advanced through the dorsum surface of the tongue into the interior of the tongue. The method of claim 1, The electrode is a tongue volume reduction method characterized in that the advancing into the interior of the tongue through the tip (tip) of the tongue. Providing an incision agent source coupled to the incision agent delivery device; Advancing at least a portion of the incision agent delivery device into the tongue; Delivering a sufficient amount of incision agent from the incision agent delivery device to the interior of the tongue to reduce volume of the tongue without damaging the sublingual nerve; And, And retracting the incision agent delivery device from the interior of the tongue. The method of claim 16, The method of reducing tongue volume, characterized in that the cutting agent is a chemical component or a mixture of components. The method of claim 16, The incision agent is a tongue volume reduction method, characterized in that it comprises an alcohol component. The method of claim 16, The incision agent is a tongue volume reduction method, characterized in that the chemotherapy agent. The method of claim 19, And providing an RF electrode for delivering electromagnetic energy to the inner region of the tongue.