CN1224338A - Apparatus for cosmetically remodeling body structure - Google Patents

Abstract

An apparatus that reduces a volume of a selected site in an interior of the tongue includes a handpiece means and an electrode means at least partially positioned in the interior of the handpiece means. The electrode means includes an electrode means electromagnetic energy delivery surface and is advance able from the interior of the handpiece means into the interior of the tongue. An electrode means advancement member is coupled to the electrode means and configured to advance the electrode means an advancement distance in the interior of the tongue. The advancement distance is sufficient for the electrode means electromagnetic energy delivery surface to deliver electromagnetic energy to the selected tissue site and reduce a volume of the selected site without damaging a hypoglossal nerve. A cable means is coupled to the electrode means.

Description

Consider body structure modified device attractive in appearance

Invention field

The present invention relates to the method for a kind of patient's of maintenance last airway open, relate in particular to and a kind ofly adopt electromagnetic energy to extract the selected part of tongue and/or lingual tonsil but do not damage hypoglossal method.

Invention field

The sleep apnea syndrome is a kind of internal disease, it is characterized in that excessive daytime drowsiness (hypersomnomulence), and morning, arm was painful, intellectual deterioration, and cardiac arrhythmia is snored in bed and is tossed about.Outbreak causes suffocating again and again in bed owing to patient for this.This syndrome generally is divided into two types.A kind of is " center sleep apnea syndrome " (central sleep apnea syndrome), it is characterized in that losing repeatedly Repiration.Second kind is the sleep apnea syndrome that causes obstruction, it is characterized in that in the sleep process since patient on air flue or patient respiration road to the cephalad of larynx but do not comprise that part of obstruction of larynx makes the outbreak repeatedly that suffocates.

Treatment up to now comprises internal medicine, surgery and physical measure.Medical treatment comprises that use such as general Lip river is for woods (protriptyline), medroxyprogesterone acetate, acetazolamide, theophylline, nicotine with except avoiding suppressing such as tranquilizer or ethanol etc. the medication of the other drug the nervous system of center.Above-mentioned internal medicine measure is helpful sometimes, but seldom in full force and effect.In addition, medication often has undesirable side effects.

Operation comprises the surgical operation and the tracheostomy of uvula jaw pharynx anaplasty (uvulopalatopharyngoplasty), tonsillectomy, the serious retrognathia of rectification.In a kind of procedure, jaw is shifted and pulls out forward, so that can touch the tongue base portion.These methods may be effectively, but owing to the too big patient of operation risk dare not use, so these methods patient often can not accept.

Physical measure comprise lose weight, the CPAP of nasopharyngeal airway (nasopharyngeal airway), nose and the tongue holding device that uses multiple night.These measures may part effectively, but unusual trouble feels under the weather, patient often can not adhere to continuing to use them in long-time.Lose weight and also may effectively realize but patient is very difficult.

In having the syndromic patient of center sleep apnea, used phrenic nerves (phrenic nerve) or diaphragm pace-making.Phrenic nerves or diaphragm pace-making comprise the use electricity irritation, to regulate and control patient's both sides are subjected to the diaphragm of phrenic nerves domination, to help and to support ventilation.This pacing method is disclosed in " diaphragm directly stimulates " that people such as J.Mugica write, " to the preliminary test of patient's flesh diaphragm pacing system " of publishing in that " PACE " second portion, the people such as J.Mugica in " nerve stimulation " of the 1-2 month in 1987 the 10th volume write, publish in " medical science and biology " in " nerve stimulation summary " 1985 263-279 pages or leaves and in June, 1993 " breathing electrically activated " of writing by NochomovitezIEEE Eng..

But, find that many such patients also have obstructive sleep to a certain degree to suffocate, when pacemaker was strengthened inspiratory force, this obstructive sleep suffocated and increases the weight of.The ventilation that causes by the activation diaphragm also can make air flue fall down when air-breathing, and patient's tongue is drawn toward throat down, thereby patient is blocked.These patients need tracheostomy subsequently, to obtain sufficient treatment.

The physiology larynx pacemaker of describing in from the people such as F.Kaneko of Trans Am Soc ArtifIntern Organs1985 " physiology larynx pacemaker " detects the capacity by the lung discharging, and stimulate suitable nerve, administer dyspneic problem with the glottis of opening patient.This equipment does not have effect for handling sleep apnea.This equipment produces a kind of and proportional signal of lung discharged air volume, and the signal of Xing Chenging is too late like this, and can not be as the indicator of treatment sleep apnea.Owing to block, in sleep apnea, often do not have the discharging of air.

The effective a kind of measure that suffocates is a tracheostomy to obstructive sleep.But this surgical operation is accompanied by sizable sickness rate, and does not also accept it from the many patients of aesthstic angle.Other Surgery Treatment comprises pull tab head as far as possible forward and prescinds and remove part tongue and other structures that airway passage is gone up in sealing by surgical operation.

Therefore need a kind of method and apparatus to overcome these difficulties.

Brief summary of the invention

Therefore, an object of the present invention is to provide a kind of equipment that reduces the volume at the inner selected position of tongue.

Another object of the present invention provides a kind of equipment that reduces the volume at the inner selected position of tongue, equipment comprises an electrode and an electrode propulsion plant, wherein the electrode propulsive element makes electrode be pushed into one section forward travel distance in tongue inside, this distance is enough to make electrode electromagnetic energy transmission surface that electromagnetic energy is sent to selected tissue site, is not damaging the volume that reduces selected position under the hypoglossal situation.

A further object of the invention provides a kind of equipment that reduces the volume at the inner selected position of tongue, this equipment comprises an electrode and an electrode propulsion plant, wherein the electrode propulsive element makes electrode advance to placement location in tongue inside, so that at this placement location, enough electromagnetic energy can be transmitted in the transmission surface of one electrode electromagnetic energy, are not damaging the volume that reduces selected position under the hypoglossal situation.

Another purpose of the present invention provides a kind of equipment that reduces the volume at the inner selected position of tongue, this equipment has the electrode propelling length that an electrode, electrode electromagnetic energy transmission surface and an outside from head extend to tongue inside, wherein advance length to be enough to the electrode electromagnetic energy is transmitted surface alignment in selected position and the enough electromagnetic energy of transmission, do not damaging the volume that reduces selected tissue site under the hypoglossal situation.

A further object of the present invention provides a kind of equipment that reduces the volume at the inner selected position of tongue, and this equipment comprises an electrode, and electrode has one can not damage the geometry that reduces the volume at selected position under the hypoglossal situation.

These and other objects of the present invention are to realize with reducing at the inner equipment of selecting the volume at position of tongue.Equipment comprises that a head and is positioned at the electrode of catheter interior to small part.Electrode comprises that an electrode electromagnetic energy transmits the surface, and electrode can advance to tongue inside from head inside.One electrode propulsive element is connected in electrode, and can make electrode at one section forward travel distance of the inner propelling of tongue.The electrode electromagnetic energy that is enough to forward travel distance make transmits the surface electromagnetic energy is sent to selected tissue site, reduces the volume at selected position under the situation of not damaging nervus sublingualis and/or tongue surface.One cable is connected in electrode.

In another embodiment, the electrode propulsive element can make at least a portion of electrode advance to the placement location of tongue inside.In this position, the electrode electromagnetic energy transmits the surface and transmits enough electromagnetic energy, is not damaging under the hypoglossal situation, reduces the volume at selected position.

In yet another embodiment, electrode has the electrode propelling length that an outside from conduit extends to tongue inside.Advance length to be enough to the electrode electromagnetic energy is transmitted surface alignment in selected position and the enough electromagnetic energy of transmission, do not damaging the volume that reduces selected tissue site under the hypoglossal situation.

Electrode is a RF electrode that is connected in the RF energy preferably.Can comprise that one is positioned at the chiller of catheter interior, the selected surface of this chiller cooling tongue to small part.One current velocity controller is connected in chiller, so that the flow velocity of the cooling medium of chiller is flow through in control.

One insulator is positioned at the electrode outside at least in part, and limits the electromagnetic energy transmission surface of electrode.Can comprise that at a plurality of positions insulator ends, electrode end and catheter outer surface are provided with pick off.

In one embodiment, first sensor is positioned at the end of electrode, and second pick off is positioned at the end of insulator.

One feed back control system is connected in electrode, all pick offs and electromagnetic-energy.In addition, an infusion medium source is connected in electrode.

Brief Description Of Drawings

Fig. 1 is the cutaway view that is used for an excision equipment of the inventive method;

Fig. 2 is a cutaway view, and it shows the conduit and the coupling of excision equipment shown in Figure 1;

Fig. 3 is the axonometric chart of coupling shown in Figure 1;

Fig. 4 is the view of the needle electrode that links to each other with excision equipment shown in Figure 1;

Fig. 5 is the view that is used for a flexible needle electrode of the inventive method;

Fig. 6 shows the cut-away area that forms with excision equipment shown in Figure 1;

Fig. 7 is the tongue cutaway view of face closure;

Fig. 8 is the open tongue cutaway view of face;

Fig. 9 is the axonometric chart of tongue;

Figure 10 is the axonometric chart at tongue back;

Figure 11 is the cutaway view of tongue;

Figure 12 is the cutaway view of tongue, and it shows the formation of hypoglossal position and cut-away area;

Figure 13 is the cutaway view of tongue, and it shows a plurality of cut-away areas;

Figure 14 is the axonometric chart of tongue front side surface;

Figure 15 is the cutaway view of tongue;

Figure 16 is a block chart, and it shows an analogue amplifier, simulation transport multiplexer and the microprocessor that is used for feedback control system;

Figure 17 is a block chart of temperature/impedance feedback system that is used for the conduit control cooling medium flow velocity by Fig. 1;

Figure 18 one is used for controlling the block chart of temperature/impedance feedback system of the cooling medium flow velocity of the conduit by Fig. 1;

Figure 19 is a graphics, and it shows the tongue shrinking percentage after the RF excision;

Figure 20 is a view, and it shows the collapse in two dimensions with the Sonchus arvensis L. tissue of RF excision;

Figure 21 is a view, and it shows the three-dimensional shrinkage of the Sonchus arvensis L. tissue that causes owing to the RF excision; And

Figure 22 is a view, and it shows the percentage ratio of the tongue change in volume after the RF excision.

The detailed description of invention

The method of considering remodeling attractive in appearance and removing part tongue volume, uvula, soft palate, lingual tonsil and/or adenoid vegetation provides a kind of excision equipment, and this equipment comprises an electromagnetic-energy and one or more electromagnetic energy carry electrode that is connected in electromagnetic-energy.Have at least an electrode to enter the inside of tongue.Come enough electromagnetic energy of self-electrode to remove a part of tongue, but do not damage nervus sublingualis.Take out electrode from the inside of tongue then.By removing the tongue partial volume but do not damage the method that nervus sublingualis obtains to treat airway obstruction.Electrode can or import tongue by chin portion below the tip of the tongue, front side surface, back, tongue, along the tongue center line in some cases.Tongue is excised (excision) by part, but can not damage nervus sublingualis, makes tongue remodeling thus and considers change attractive in appearance.This is to leave nervus sublingualis place enough far away and do not realize so that can not damage nervus sublingualis in electromagnetic energy is sent to the process of tongue by electrode is placed on.Another method of treatment airway obstruction is by removing lingual tonsil but do not damage nervus sublingualis and realize.

Consult Fig. 1 and 2, there is shown the excision equipment 10 of considering remodeling attractive in appearance and removing part tongue, lingual tonsil, uvula, soft palate and/or adenoid vegetation.Excision equipment 10 can be placed like this, one or more energy transfer arrangements or electrode can be imported the inside of tongue by tongue.Excision equipment 10 comprises having or that do not show, AT intubate, with transmission oxygen or anesthetis, and can suck blood or other secretions.Should be understood that, that this excision equipment 10 can be used for treating the difference that air duct is restricted in the multiple health and blocks.Embodiment is with electrode 12 treatment sleep apneas, so that the selected part of excising (necrocytosis) tongue, lingual tonsil and/or adenoid vegetation with resistive heating, RF (radio frequency), microwave, ultrasound wave and/or the hot liquid jet.The preferable energy is the RF source.Like this, excision equipment 10 can be used to excise the material that includes but not limited to tongue, tonsil, turbinates, soft palate tissue, sclerous tissues and viscosity tissue.In one embodiment, excision equipment 10 can be used to remove the part tongue, so that increase the cross-sectional area of air flue.A kind of sterilization medium import part and will sterilizes in the medium importing oral cavity, so that reduce the infection of cut part.

Remove before the part tongue, carry out surgical operation evaluation in advance, comprise that health check-up, fibre optics pharyngoscope, cephalometer analysis and polygraph monitor.The health check-up emphasis is the evaluation of head and cervical region.It also comprises press close to check (the close examination) of nasal cavity, to differentiate the obstruction deformity of barrier film and turbinates; One long unnecessary soft palate or loose amygdaline oropharynx blocks; And the following pharyngemphraxis of tongue protuberance base portion.

Excision equipment 10 comprises a conduit 14, the handle that can be selected for use 16 and one or more electrode 12, all different mouth 18 that electrode 12 forms from the vertical surface along conduit 14 or stretch out from the far-end of electrode 12.Conduit 14 can be a head.A propulsion plant 20 can be provided.Propulsion plant 20 comprises the guide rail that is arranged on conduit 14 inside or manages 23.Electrode 12 can be arranged in the guide rail 23 and be advanced to the inside of tongue from guide rail.

Excision or excision equipment comprise that a conduit 14, can select handle 16 and the one or more excisions source transporter 12 that uses, and an all different mouth 18 that transporter 12 forms from the vertical surface along conduit 14 or a distal portion of excision source transporter 12 are stretched out.Conduit 14 can be a head.The propulsion plant 20 of excision source transporter can be set, be also referred to as propulsion plant 20.The propulsion plant 20 of excision source transporter can comprise the guide rail that is arranged on conduit 14 inside or manage 23.Excision source transporter 12 can be arranged in the guide rail 23 and be advanced to the inside of tongue from guide rail.Cable is connected in excision source transporter 12.

Excision source transporter 12 can be positioned at the inside of conduit 14 to small part.In one embodiment, excision source transporter 12 moves forward and backward by a mouth 18 that is formed in conduit 14 outer surfaces.The device 20 of moving forward and backward of excision source transporter is released the conduits 14 outer inside that enter body structure to excision source transporters 12, and excision source transporter 12 is withdrawed from from the inside of body inner structure.Though the body inner structure has can multiple different structure, the style inner structure refers to tongue down.Excision source transfer equipment 12 passes the outer surface of tongue, and the inside of guiding tongue.Enough excision energy are sent to the inside of tongue by excision source 12, make tongue can be cut fully and part remove.Excision source transfer equipment 12 can be the structure of a sky, promptly ethanol or other liquid or semiliquid (ⅱ) are transmitted in (ⅰ) excision position (so that chemical ablation) of being suitable for different chemicals is sent to chosen tongue inside, to excise and to transmit multiple different infusion medium, include but not limited to saline, chemotherapy or the like.Can make up different forms to carry out required excision, include but not limited to RF in conjunction with chemotherapy, chemicals in conjunction with chemotherapy etc., excision source transfer equipment 12 has a restricted transmission range in tongue.In an embodiment with RF electrode, this is to realize with an insulated sleeve that surrounds the electrode outside.Other device comprises that one is positioned at the propulsive structure of restriction of excision source transfer equipment 12, or source transfer equipment 12 propulsive structures such as similarity pieces such as retainers are excised in a restriction that is connected in conduit.A kind of suitable fluid is an electrolyte solution.Replace directly and transmit heat energy, can use a refrigerative electrolyte solution that heat energy is sent to tissue with contacting of tissue and electrode 12.Electrolyte solution can be cooled in the scope of about 30 to 55 degree C.

Conduit 14 comprises that tissue contacting surface 22, a cooling medium input pipe 24 and of a conduit pass the conduit 14 inner cooling medium outlet tubes 26 that extend.Mouth 18 is formed on the outside of conduit 14, is preferably formed on the tissue contacting surface 22 of conduit.Mouth 18 is isolated with mobile cooling medium in input pipe and outlet tube 24 and 26.Cooling medium input pipe 24 and outlet tube 26 can provide at least 1 to 2 square centimeter the part that is cooled for the tissue contacting surface 22 of conduit.Be more preferably, the part that is cooled of the tissue contacting surface 22 of conduit equals the transversal diameter in the following zone of excising at least.

In one embodiment, the part that is cooled of the tissue contacting surface 22 of conduit equals the transversal diameter in the following zone of excising at least.In another embodiment, the part that is cooled of the tissue contacting surface 22 of conduit only provides cooling for the zone relevant with each unfolded excision source transporter.

The size of the part that is cooled of the tissue contacting surface 22 of conduit changes with each patient.It is enough big that this size is wanted, so that the protuberance of the tongue after the electromagnetic energy transmission is minimum.Protuberance can reduce 50% or more, 75% or more and 90% and Geng Duo.The amount of cooling water that is provided is enough to make patient just can go home in the short time after finishing removing operation, and the danger that can not make tongue occur blocking.Have found that, sufficient cooling is provided on bigger zone, can enlarge the excision amount in the tongue interior zone, provide the fully enough big part that is cooled, make adenoma reaction (adenomas response) reach minimum by tissue contacting surface 22 for conduit.

Handle 16 is preferably made by insulant.All electrodes 12 are by making such as stainless conductive material.In addition, electrode 12 can by the memory metal that is shaped such as can be from California, the NiTi bought of the Raychem company of Menlo Park makes.In one embodiment, have only the end of electrode 12 to make, so that reach required skew by the memory metal that is shaped.Conduit 14 can advance always when conduit 14 is led in the human mouth, till patient begins occur to feel sick or suffocate reaction.Return conduit 14 then, in order to avoid patient feels sick or suffocates.The end of electrode 12 can be half bending.Terminal geometry is consistent with the outside of tongue.

In one embodiment of the invention, conduit 14 is heads.In this embodiment, do not need independent handle 16.Excision equipment 10 can be used for treating the interior zone of tongue.Conduit 14 has a size can be positioned at the end of inside, oral cavity.Excision source transporter 12 is positioned at the inside of conduit 14 to small part.Excision source transporter 12 comprises that excision transmits surface 30.In the time of near conduit is positioned at tongue surface, excision source transporter 20 is connected in excision source transporter 12 and is calibrated, with from conduit 14, include but not limited to the terminal position of conduit, excision source transporter 12 is advanced to the inside of tongue.Excision source transporter 12 has advanced one section sufficiently long progressive distance 33 from conduit 14, with the interior zone with excision energy and/or excision effect treatment tongue, but can not damage nervus sublingualis or tongue surface.

Conduit 14 is ductile, to meet the surface configuration of tongue when having selected the excision target.Can form ductile conduit 14 with a kind of soft metal such as copper of encapsulation or once annealed metal/plastic material.All or part of of conduit 14 is ductile or made by a memory metal that is shaped.

For many application scenarios, require the end 14 ' of conduit 14 to be offset.This can realize by mechanical means or with memory metal.One switch-back or other frame for movement can be contained in terminal 14 ' outside or the inside.In one embodiment, the doctor operates a be offset button that is positioned at handle 16 and makes switch-back tight.Can make terminal 14 ' withdrawal like this, make its skew.It will also be appreciated that available other machinery replaces switch-back.Need this skew for unapproachable tissue site.

Under feedback control, adopt the tongue volume controlledly to reduce effectively to open the perforate in the airway passage.Can use the medicament of many different releasing miseries, include but not limited to lidocaine.Can use a digital ultrasound measurement system.Ultrasonic measurement can be determined the quantity of change of shape biologically quantitatively, provides ultrasound wave to transmit and receives, and uses piezoelectric transducer (crystal) and the data of efflux are provided.

Also the disinfectant medium can be imported part 21 and introduce the oral cavity.Before excision, in the process of excision and/or after the excision, can introduce the disinfectant medium.Can constantly transmit.According to the volume of wanting the disinfectant oral cavity select in the oral cavity disinfectant what.The disinfectant grade can change.Carry out disinfection and to reduce the infection of cut body inner structure.The disinfectant medium imports part 21 can be before excision equipment 10 imports, import after or introduce the oral cavity in the process of importing.In addition, can when from the oral cavity, taking out excision equipment 10 or in different, take out the disinfectant medium and import part 21.

Disinfectant import part 21 can be included in the excision equipment 10, in the inside of conduit 14 or in the outside of conduit 14, it also can be one has an energy disinfectant is imported the whole of oral cavities or selected partly the guiding piece in a chamber from disinfectant source 23.Disinfectant medium guiding piece 21 can move in the oral cavity, so that provide sterilization for oral cavity whole or an only part.In this article, the oral cavity is meant that infectious microorganism can introduce the inside of human body environment of cut tongue, soft tissue structure and similar structures.Disinfectant medium guiding piece 21 is slidably located in the conduit 14 or in its outside.Perhaps, disinfectant medium guiding piece 21 can be a kind of optical fiber that is connected in the light energy source that includes but not limited to UV source 25.Optical fiber also is slidably located in the oral cavity.Optical fiber is constructed to be permeable to provide selectable sterilization for the oral cavity of a part all or only, and has many different ends to reach this purpose.

The disinfectant that is suitable for includes but not limited to Peridex, promptly in collutory (the didextrose acid 1 that contains 0.12% gluconic acid hibitane (chlorhexidine glucinate) that contains in water base, two (5-rubigan) biguanide of 1 '-hexa-methylene) (1,1 '-hexanethylenebis (5-(p-chlorophenyl) biganide) di-D-gulconate), 11.6% ethanol, glycerol, PEG40 sorbitan aristolic acid (sorbitan arisoterate), spice, dosium glucide and FD﹠amp; Blue No. 1 of C.

It should be understood that many different disinfectant all can adopt, comprise other electromagnetic wavelength and all chemical complexs.

Electrode 12 to small part is positioned at the inside of conduit 14.Each electrode 12 moves forward and backward by a bite 18 that is formed in conduit 14 outer surfaces.The device that moves forward and backward makes electrode 12 before conduit 14 and then enter the inside of body inner structure, is withdrawn into conduit 14 again.The outer surface that all electrodes 12 pass tongue enters the interior zone of tongue.Electrode 12 is sent to the inside of tongue with enough electromagnetic energy, makes the tongue can be cut fully and extract.Electrode 12 can be hollow, to hold multiple different infusion medium, includes but not limited to saline.Counter electrode 12 can limit the distance that they can enter tongue.This can be with a kind of insulated sleeve, a kind ofly be positioned at limiting their progressive structures or a kind of all electrode 12 progressive structures of restriction that are connected in conduit, realize such as retainer and similarity piece on the electrode 12.

Can introduce the disinfectant medium before excision, in the excision process and/or after the excision.Can transmit continuously.Select degree of disinfection in the oral cavity according to the volume of wanting the disinfectant oral cavity.The disinfectant grade can change.Carry out disinfection and to reduce the infection of cut body inner structure.

Available adjustable or nonadjustable insulated sleeve 32 (Fig. 3,4 and 5) is regulated excision and is transmitted the surface, transmits surface 30 such as the electromagnetic energy of electrode 12.Insulated sleeve 32 can be along the outer surface forward-reverse of electrode 12, so that increase or reduce the length that electromagnetic energy transmits surface 30.Insulated sleeve 32 can be made of a variety of materials, and includes but not limited to nylon, polyimides, other thermoplastic and materials similar.The size that electromagnetic energy transmits surface 30 can change with other method, includes but not limited to form one and has the segmented electrode and the similar method of a plurality of electrodes that can multiplexed and independent startup.

Consult Fig. 4 especially, excision source transporter 12 has one from the outer surface extension of conduit 14 and the propelling length 33 that enters tongue inside.Advance length 33 enough to make excision transmit surface 30 and be positioned at selected tissue site in tongue inside.Excision transmits surface 30 and has enough length, makes the excision effect be sent to chosen tissue site, forms the excision of required degree at selected tissue site, and does not damage nervus sublingualis.Excision transmits surface 30 not always at the end of excision source transporter 12.Insulated sleeve 32 also can be positioned at the end of excision source transporter 12.In this embodiment, excision transmits the end that surface 30 does not extend to excision source transporter 12.But excision transmits surface 30 and still transmits enough excision effects, forming the necrocytosis of required degree in the selected tissue site of tongue inside, but does not damage the surface of nervus sublingualis and/or damage tongue.In addition, have only a side of excision source transporter 12 or the part of a side to be insulated.This also provides and can be positioned at all places of tongue and comprise near hypoglossal excision source transporter 12.Several is the close hypoglossal places of excision source transporter, and excision source transporter 12 all is insulated.

In one embodiment, advancing length is 1.2 to 1.5 centimetres, and the length that excision transmits surface 30 is 5 to l0 millimeters, is more preferably about 8 millimeters.

In another embodiment, when importing, especially during the back of tongue, advance length 33 to reach nervus sublingualis inadequately by any tongue surface.

Propulsion plant 20 can make at least a portion of each excision source transporter 12 advance to the placement location of tongue inside.Propulsion plant 20 can also make each excision source transporter 12 withdrawal.At placement location, excision transmits the surface and transmits enough excision energy and/or effect, reducing the volume at selected position, but can not damage nervus sublingualis and/or tongue surface.In one embodiment, the device 20 that moves forward and backward excision source transporter, that have or do not have guide rail 23 is with one with respect to conduit 14 longitudinal axis 60 to 90 degree, preferably the inside of tongue is delivered in the transmission that will excise source transporter 12 of the angle about about 70 degree from conduit 14.

In certain embodiments, excision source transporter 12 has geometry, includes but not limited to the structure of a bending, and this structure comprises one or more insulated surfaces; Perhaps partly insulate or on near-end or insulating endways surface, be configured to reduce the volume of selected tissue site but can not damage hypoglossal or the like analogous shape in a side.In one embodiment, excision source transporter 12 passes through any tongue surface and imports, and is configured to be provided with insulator 32 near the part of hypoglossal excision source transporter 12.As previously mentioned, insulator 32 can be arranged on the different parts of excision source transporter 12.

Handle 16 comprises that one is connected in the coupling 34 of propelling and setback device 20.Coupling 34 makes all electrodes 12 be connected in power, feedback control, temperature and/or imaging system.Can comprise a RF/ temperature control unit 36.

In one embodiment, the doctor along one day coupling 34 ends direction move and advance and setback device 20.All electrodes 12 can add upper spring.When advancing and setback device 20 when mobile backward, spring advances selected all electrodes 12 and leaves conduit 14.

One or more cables 38 are connected in an electromagnetic-energy 40 with all electrodes 12.The present invention can use various energy resources 40, and electromagnetic energy is transferred to the inside of body structure, the energy includes but not limited to RF, microwave, ultrasound wave, coherent light or heat transfer.Preferably, the energy 40 is RF generators.When using the RF energy, the doctor can drive the RF energy with a foot control (not shown) that is connected in the RF energy 40.

One or more pick offs 42 can be arranged on the inside of electrode 12 or outer surface, the insulated sleeve 32, or the inside of inserting body structure independently.All pick offs 42 can accurately be measured the temperature of tissue site, so that determine: (ⅰ) Qie Chu scope, whether (ⅱ) Qie Chu amount (ⅲ) also needs further excision, and (ⅳ) border or the periphery of cut geometry.In addition, pick off 42 prevents that the tissue of non-excision target is damaged or excises.

Pick off 42 can be traditional structure, includes but not limited to critesistor, thermocouple, resistance wire and similar structures.The pick off 42 that is suitable for comprises a copper constantan T type thermocouple, J type, E type, K type, optical fiber, resistance wire, thermocouple IR detector or the like.Should be understood that, that pick off 42 not necessarily wants heat sensor.

Pick off 42 is measured temperature and/or impedance, so that can excise monitoring.Can reduce damage like this to the surrounding tissue of target excision body.By the multiple-point temperature of being permitted of monitoring body structure inside, just can determine to excise peripheral extent, finish to determine when to excise.If at any time, pick off 42 is measured required excision temperature and has been surpassed, and the energy 40 will be received a suitable feedback signal so, regulates the energy that is transmitted.

Excision or remove equipment 10 and have display capabilities includes but not limited to observation display, expanded type eyepiece, fibre optics, video imaging or the like.

In addition, available ultrasonic imaging comes the amount of localizing electrode 12 and/or definite excision.One or more ultrasonic sensors 44 can be arranged in the electrode 12, conduit 14 go up or an independent device on.Also can use an imaging probes in the inside or the outside of selected tissue site.A kind of suitable imaging probes is 21362 types, is made and is sold by Hewlett Packard company.Each ultrasonic sensor 44 is connected in a ultrasound source (not shown).

Consult Fig. 6 now, the conduit 14 shown in the figure has imported the oral cavity, and a plurality of RF electrodes 12 have entered the inside of tongue, have formed different cut-away area 46.Use RF, can bipolar or unipolar mode operate excision equipment 10.In Fig. 6, operate all electrodes 12 in bipolar mode, form enough cut-away areas 46, removing the part tongue, but do not influence nervus sublingualis, and form a bigger airway passage.Use this excision method, move along leaving air flue direction forward the back of tongue.Increased the cross-sectional diameter of air flue like this.

Use RF, also can unipolar mode operate excision equipment 10.One ground pad (groundpad) is positioned at a position easily, for example below chin.One single electrode 12 is arranged in tongue, to form first cut-away area 46.Electrode 12 is from the inside withdrawal of tongue then, and mobile conduit 14, electrode 12 enter the other interior zone of tongue again from conduit 14.Form one second cut-away area 46.This process can be carried out any many number of times, forms different excision districts with the inside at tongue.Available more than one electrode 12 imports tongue and operates with bipolar fashion.All then electrodes are reorientated any many number of times in tongue inside, to form a plurality of connections or unconnected cut-away area 46.

Consult Fig. 7 to 15 now, there is shown the various cutaway views of separating of tongue and other structure.Various anatomical structure is as follows: with 48 bodies of representing genioglossus or tongue; Represent geniohyoid with 50; Represent mylohyoid (mylohyoid muscle) with 52; Represent hyoid bone with 54; Represent the tip of the tongue with 56; Represent the tongue front side surface with 58; Represent the tongue back with 60; Represent dorsal part under the tongue with 62; Represent the paddy reflection with 64; Represent the tongue folliculus with 66; Represent uvula with 68; Represent gland sample district with 70; Represent the tongue outer ledge with 72; Represent profile shape nipple with 74; Represent palatine tonsil with 76; Represent pharynx with 78; Represent unnecessary pharynx tissue with 80; With 82 indication window caecums; Represent nervus sublingualis with 84; And with 86 lingual frenum of representing tongue.

The back 60 of tongue is divided into 2/3 and following dorsal part 62 in front.Profile is according to profile shape nipple 74 and 82 decisions of hole caecum.Following dorsal part 62 is under the profile shape nipple 74 and the back surface on the paddy reflection 64.Paddy reflection 64 is the darkest surface portions of the contiguous epiglottis of tongue.Tongue folliculus 66 comprises lingual tonsil.

Conduit 14 can import by nose or by the oral cavity.All electrodes 12 can pass through the inside that back surfaces 60, following back surface 62, front side surface 58, the tip of the tongue 56 or geniohyoid 50 insert tongues.In addition, electrode can import the inside and the gland sample district 70 of tongue folliculus 66.In case surface 30 with regard to adjustable, insulating sleeve pipe 32, is transmitted for each electrode 12 provides required electromagnetic energy in electrode 12 location.

Under the situation of not damaging nervus sublingualis 84, form cut-away area 46.This has formed a bigger airway passage, and provides treatment to sleep apnea.

In all examples, the formation of the location of all electrodes 12 and cut-away area 46 will make the not cut or damage of nervus sublingualis 84.Make the ability of swallowing and speaking not weakened.

In one embodiment, RF electrode 12 is placed on the back surfaces of tongue.First electrode is positioned at the place near 0.5 centimetre of profile shape nipple.Other electrode 12 and apart 1.6 centimetres and 1 centimetre of tongue central axis.In one embodiment, adopt 465Mhz RF.The temperature of electrode 12 ends is about 100 ℃.The terminal temperature of insulated sleeve 32 is about 60 ℃.In another embodiment, the temperature of insulated sleeve 32 ends be 43 ℃ and on.RF can be the short pulse of low frequency RF.Can obtain the accurate location at required excision position.Available one or more electrode 12 forms the excision of three-D volumes.Excision can be all geometries, include but not limited to rectilinear, polyhedral, the shape that redefines, symmetric and asymmetrical shape.

Consult Figure 16 and 17, one open loops or closed loop feedback system now pick off 42 is connected in the energy 40.The temperature of monitoring tissue or electrode 12, thereby the output of the adjusting energy 40.In addition, disinfectant degree in the monitoring oral cavity.If desired, the doctor can be without closed loop or open cycle system.Closed loop or open cycle system can comprise and adopt a microprocessor, with opening and closing output and modulation power.Closed loop system adopts a microprocessor 88 as a controller, wipes temperature, regulates RF power, observed result, sends into result, modulation power then again with prison.

Owing to used pick off 42 and feedback control system, being organized in of contiguous RF electrode 12 can remain on a temperature desired in seclected time and can not go wrong.Each electrode 12 is connected in and can produces the resource of an independent output for each RF electrode 12.Output makes RF electrode 12 keep a selected energy in one selectes for a long time.

When using a RF electrode 12, current sensor 90 can be measured the electric current that transmits by RF electrode 12.Voltage is measured by voltage sensor 92.Computing impedance and power on power and impedance computation device 94 then.Show these numerical value at user interface and display 96 subsequently.Controller 98 accepts to represent the signal of power and resistance value.

The proportional control signal of difference between controller 98 generations one and actual measured value and the desirable value.Power circuit 100 uses control signal that output is adjusted to a suitable amount, so that keep required delivering power at each RF electrode 12.

In a similar approach, the temperature that pick off 42 is surveyed provides feedback, so that keep a selected power.Temperature measuring equipment 102 is measured actual temperature, and described temperature shows on user interface and display 96.Controller 98 produce one and the actual measurement temperature and temperature required between the proportional control signal of difference.Power circuit 100 uses control signal that output is adjusted to a suitable amount, so that keep required transmission temperature at each pick off place.An available multiplexer (multiplexer) is measured electric current, voltage and the temperature of many pick offs 42, energy can one pole or bipolar mode be sent to RF electrode 12.

Controller 98 can be a kind of digital or analog controller, or has the computer of software.When controller 98 was a computer, it can comprise a CPU by the system busbar connection.In this system, keyboard, disc driver or other Nonvolatile memory system can be arranged, a display, and other ancillary equipment, these all are that people know.Be connected in a program memory system and the data-storage system in addition of bus.

User interface and display 96 comprise operator's control piece and display.Controller 98 can be connected in imaging system, includes but not limited to ultrasound wave, CT scanner, X ray, MRI, mammography or the like.In addition, can adopt directly visual and sense of touch imaging.

Controller 98 uses the output of current sensor 90 and voltage sensor 92 to keep the selected power level at RF electrode 12 places.The amount of the amount control power of the RF energy that is transmitted.Controller 98 can comprise the power profile that is transmitted.The predetermined power that transmits also can be drawn.Controller 98 can use other pick off that is similar to pick off 90 and 92, so that other excision source transporter 12 can keep the excision energy and/or the excision agent of a controllable number system.

Circuit, software and to the feedback generation process control of controller 98 with keep selected, be independent of the power that promptly is not subjected to voltage or electric current variable effect, and be used for changing (ⅰ) selected power, (ⅱ) cycle of operation (on-off and wattage), (ⅲ) bipolar or one pole energy transmits, and (ⅳ) infusion medium transmission, comprise flow velocity and pressure.These process variables are controlled and change, and meanwhile, keep required delivering power, are not subjected to influence that voltage or electric current change but temperature controlled according to pick off 42 monitoring.

Current sensor 90 and voltage sensor 92 are connected in the input of an analogue amplifier 104.Analogue amplifier 104 can be a traditional differential amplifier circuit that uses with pick off 42.One analog multiplexer, 106 orders are connected in the outfan of analogue amplifier 104 input of A/D converter 108.The outfan of analogue amplifier 104 is a voltage of representing each temperature that is got by sensor measurement.The digitized amplifier output voltage is supplied to microprocessor 88 by A/D converter 108.Microprocessor 88 can be a kind of 68HCII that buys from Motorola (Motorola).But, should be understood that, that any suitable microprocessor or general general digital or analogue computer all can be used for computing impedance or temperature.

The numeral of representing impedance and temperature is accepted and stored to microprocessor 88 orders.Each numerical value that microprocessor 88 is accepted is corresponding to different temperature and impedance.

Power that is calculated and resistance value can show on user interface and display 96.Perhaps, except the indication of the numeral of power or impedance, available microprocessors 88 is made comparisons the impedance of being calculated and performance number and power and impedance limit value.When numerical value surpassed predetermined electric power or resistance value, user interface and display 96 just gave a warning, and in addition, reduced, change or interrupt the transmission of RF energy.Control signal from microprocessor 88 can change the watt level of being supplied by the energy 40.

Figure 18 shows the block chart that can be used to by the temperature/impedance feedback system of conduit 14 control cooling medium flow velocitys.Electromagnetic energy is sent to electrode 12 by the energy 44, and acts on tissue.One monitor 110 is made the impedance of tissue according to the energy that is sent to tissue, and the resistance value and the setting value that record are made comparisons.If the impedance that records surpasses setting value, be delivered to the energy 40 once the signal 112 that ends or stop to carry out, further be sent to electrode 12 to stop energy.If the impedance that records is within acceptable scope, energy just continues providing organization.Be added in the process of tissue at energy, pick off 42 is measured the temperature of tissue and/or electrode 12.One comparator 114 is accepted represent the signal of dut temperature, and will be worth and represent temperature required prearranged signals to make comparisons.If tissue temperature is too high, comparator 114 is delivered to flow regulator 116 with a signal, and expression needs with higher cooling medium flow velocity, if or temperature above required temperature, just keep original flow velocity.

Example 1

Excision equipment 10 is used for determining the collapse in two dimensions of cattle.Having finished the RF volume with a needle electrode reduces.With four crystal formation squares of miniature ultrasonic.Reduce to measure to the contrast body and with the volume of 15 watts of acquisitions, with 15 watts of initial volume minimizings 13%, carried out 4 hours with 15 watts then, volume reduces 4% again.What volume reduced adds up to 17%.

Example 2

Excision equipment 10 is used for determining the three-dimensional shrinkage of Sonchus arvensis L..Also be to have finished the RF volume with a needle electrode to reduce, eight miniature ultrasonics are a crystal formation cube.Use 16 watt-hours, the volume of initial tongue reduces 17%, use 25 watt-hours, and initial volume reduces 25%, and with after 25 wattage hour, volume reduces 4% again, the volume minimizing add up to 29%.

Example 3

Apply 20 watts at first, total finishes the minimizing of 35% volume in the intravital three-dimensional scope of pig.

Consult Figure 19 now, measure the removal volume size with the digital sound of multidimensional micrometering device.The decreased average amount of Z direction is 20%, and volume contraction is 26%.Figure 20 shows owing to the three-dimensional shrinkage of carrying out the tongue tissue that RF excision (excising with 20 watts) causes in vivo with pin.Among the figure volume after contrast body volume before the excision and the excision is compared.

Figure 20 shows owing to carry out the collapse in two dimensions that RF excises the Sonchus arvensis L. that causes with needle electrode.There is shown before the excision and result afterwards.

Figure 21 with the form of scheming show 16 watts excision cause having excised the back tissue volume contraction 17%, contrast among the figure and with the contrast body.Use 25 watts excision to cause excising back volume contraction 25%.The excision again of being separated by after the excision 4 hours has obtained 4% other regions contract again.

The percent by volume that Figure 22 shows after the RF excision changes.One is 16 watts, and promptly 16 watts were excised 20 minutes; One is 25 watts, and promptly 25 watts were excised 20 minutes; Another is 25 watts (4 hours), i.e. the excision back long period (25 watts excision after 4 hours).

The above stated specification of a preferred embodiment of the present invention is the purpose of illustration and description for example.The present invention is not limited to disclosed accurate description form.Obviously, many changes and variation are conspicuous for those skilled in the art.Therefore, scope of the present invention should be limited by following claims and their equivalent.

Claims (65)

1. A device for reducing the volume of selected parts of the inside of the tongue, comprising: a head; an electrode positioned at least partially within the handpiece, the electrode including an electrode electromagnetic energy delivery surface, the electrode being advanceable from the interior of the handpiece to the interior of the tongue; an electrode advancing member connected to the electrode and capable of advancing the electrode within the tongue an advanced distance sufficient for the electromagnetic energy delivery surface of the electrode to deliver electromagnetic energy to selected tissue sites without damaging the sublingual Reduce the volume of selected sites in the case of nerves; and A cable connected to the electrodes. 2. The device of claim 1, wherein the electrodes are -RE (radio frequency) electrodes. 3. The device of claim 2, further comprising: An RF energy source connected to the RF electrodes. 4. The device of claim 1, further comprising: A cooling device located at least partially inside the handpiece and capable of cooling the surface of the tongue. 5. The device of claim 4, further comprising: A flow rate control device is connected to the cooling device and can control the flow rate of the cooling medium passing through the cooling device. 6. The device of claim 1, further comprising: An insulator is located at least partially around the exterior of the electrode. 7. The device of claim 6, further comprising: A sensor disposed at the end of the insulator. 8. The device of claim 1, further comprising: A sensor placed at the end of the electrode. 9. The device of claim 1, further comprising: A sensor arranged on the outside of the nose. 10. The device of claim 1, further comprising: A first sensor is disposed at the end of the electrode and a second sensor is disposed at the end of an insulator, wherein the insulator is located at least partially around the outside of the electrode. 11. The device of claim 1, further comprising: A feedback control device connected to the electrodes, a sensor and an RF energy source. 12. The device of claim 1, further comprising: A source of infusion medium connected to the electrodes. 13. A device for reducing the volume of selected parts of the inside of the tongue, comprising: a head; an electrode positioned at least partially within the handpiece, the electrode including an electrode electromagnetic energy delivery surface, the electrode being advanceable from the interior of the handpiece to the interior of the tongue; an electrode advancement and retraction member, which is connected to the electrode and advances at least a portion of the electrode to a placement position inside the tongue in which the electromagnetic energy delivery surface of the electrode delivers sufficient electromagnetic energy so as not to damage the hypoglossal nerve reduce the volume of the selected site; and A cable connected to the electrodes. 14. The apparatus of claim 13, wherein the electrode advancing and retracting components further comprise: A guide channel for receiving the electrode in at least a portion of the interior of the handpiece and directing the electrode in a forward direction from the handpiece to the interior of the tongue. 15. 13. The apparatus of claim 13, wherein the electrode is an RF electrode. 16. The device of claim 14, further comprising: An RF energy source connected to the RF electrodes. 17. The device of claim 13, further comprising: A cooling device located at least partially inside the handpiece and capable of cooling the surface of the tongue. 18. The device of claim 17, further comprising: A flow rate control device is connected to the cooling device and can control the flow rate of the cooling medium passing through the cooling device. 19. The device of claim 13, further comprising: An insulator is located at least partially around the exterior of the electrode. 20. The device of claim 19, further comprising: A sensor disposed at the end of the insulator. twenty one. The device of claim 13, further comprising: A sensor placed at the end of the electrode. twenty two. The device of claim 13, further comprising: A sensor arranged on the outside of the nose. twenty three. The device of claim 13, further comprising: A first sensor is disposed at the end of the electrode and a second sensor is disposed at the end of an insulator, wherein the insulator is located at least partially around the outside of the electrode. twenty four. The device of claim 13, further comprising: A feedback control device connected to the electrodes, a sensor and an RF energy source. 25． The device of claim 13, further comprising: A source of infusion medium connected to the electrodes. 26． A device for reducing the volume of selected parts of the inside of the tongue, comprising: a head; an electrode positioned at least partially inside the handpiece, the electrode comprising an electrode electromagnetic energy delivery surface and an electrode advancement length extending from the exterior of the handpiece to the interior of the tongue, wherein the advancement length is sufficient to position the electrode electromagnetic energy delivery surface at a selected location and Deliver sufficient electromagnetic energy to reduce the volume of selected tissue sites without damaging the hypoglossal nerve; an electrode advancement and retraction member, which is connected to the electrode and advances and retracts at least a portion of the electrode; and A cable connected to the electrodes. 27． 26. The apparatus of claim 26, wherein the electrode is an RF electrode. 28． The device of claim 27, further comprising: An RF energy source connected to the RF electrodes. 29． The device of claim 26, further comprising: A cooling device located at least partially inside the handpiece and capable of cooling the surface of the tongue. 30． The device of claim 19, further comprising: A flow rate control device is connected to the cooling device and can control the flow rate of the cooling medium passing through the cooling device. 31． The device of claim 26, further comprising: An insulator is located at least partially around the exterior of the electrode. 32． The device of claim 31, further comprising: A sensor disposed at the end of the insulator. 33． The device of claim 26, further comprising: A sensor placed at the end of the electrode. 34． The device of claim 26, further comprising: A sensor arranged on the outside of the nose. 35． The device of claim 26, further comprising: A first sensor is disposed at the end of the electrode and a second sensor is disposed at the end of an insulator, wherein the insulator is located at least partially around the outside of the electrode. 36． The device of claim 26, further comprising: A feedback control device connected to the electrodes, a sensor and an RF energy source. 37． The device of claim 26, further comprising: A source of infusion medium connected to the electrodes. 38． A device for reducing the volume of selected parts of the inside of the tongue, comprising: a head; an electrode at least partially inside the handpiece, the electrode being advanceable from the inside of the handpiece to the inside of the tongue, wherein the electrode has a geometry that reduces volume at the selected site without damaging the hypoglossal nerve; an electrode advancement and retraction member coupled to the electrode and capable of advancing and retracting at least a portion of the electrode; and A cable connected to the electrodes. 39． 38. The apparatus of claim 38, wherein the electrode is an RF electrode. 40． The device of claim 39, further comprising: An RF energy source connected to the RF electrodes. 41． The device of claim 38, further comprising: A cooling device located at least partially inside the handpiece and capable of cooling the surface of the tongue. 42． The device of claim 41, further comprising: A flow rate control device is connected to the cooling device and can control the flow rate of the cooling medium passing through the cooling device. 43． The device of claim 38, further comprising: An insulator is located at least partially around the exterior of the electrode. 44． The device of claim 43, further comprising: A sensor disposed at the end of the insulator. 45． The device of claim 38, further comprising: A sensor placed at the end of the electrode. 46． The device of claim 38, further comprising: A sensor arranged on the outside of the nose. 47． The device of claim 38, further comprising: A first sensor is disposed at the end of the electrode and a second sensor is disposed at the end of an insulator, wherein the insulator is located at least partially around the outside of the electrode. 48． The device of claim 38, further comprising: A feedback control device connected to the electrodes, a sensor and an RF energy source. 49． The device of claim 38, further comprising: A source of infusion medium connected to the electrodes. 50． A device for reducing the volume of selected parts of the inside of the tongue, comprising: a head; an electrode at least partially inside the handpiece, the electrode comprising an electrode electromagnetic energy delivery surface and an electrode advancement length extending from the exterior of the handpiece to the interior of the tongue, wherein the advancement length is sufficient to position the electrode electromagnetic energy delivery surface at a selected location and Deliver sufficient electromagnetic energy to reduce the volume of selected tissue sites without damaging the hypoglossal nerve. 51． A device for reducing the volume of selected parts of the inside of the tongue, comprising: a catheter device; an electrode assembly positioned at least partially within the catheter assembly, the electrode assembly capable of delivering sufficient electromagnetic energy to ablate the interior tissue of the tongue without damaging the hypoglossal nerve of the tongue; an electrode advancement and retraction member coupled to the electrode assembly to enable at least a portion of the electrode assembly to enter and exit a selected tongue surface; and A cable means connected to the electrode means. 52． The device of claim 51, further comprising: An electromagnetic energy source device connected to the electrode device and the cable device. 53． The device of claim 51, further comprising: A cooling device is located at least partially inside the catheter and cools the surface of the tongue. 54． The device of claim 53, further comprising: A device that controls the flow rate of a cooling medium through a cooling device. 55． The device of claim 51, further comprising: An insulator means is located at least partially around the exterior of the electrode means. 56． The device of claim 55, further comprising: A sensor means disposed at the end of the insulator means. 57． The device of claim 51, further comprising: A sensor means disposed at the end of the electrode means. 58． The device of claim 51, further comprising: A sensor device disposed on the outside of the catheter device. 59． The device of claim 51, further comprising: A first sensor means is disposed at the end of the electrode means and a second sensor means is disposed at the end of an insulator means, wherein the insulator means is at least partly located around the outside of the electrode means. 60． 51. The apparatus of claim 51, wherein the electrode means is an RF electrode connected to an RF generator. 61． 51. The apparatus of claim 51, wherein the electrode means is a microwave antenna connected to a microwave source. 62． The device of claim 51, further comprising: A feedback control device connected to the electrode assembly and an electromagnetic source. 63． The device of claim 62, further comprising: An ultrasonic device connected to the feedback control device. 64． 51. The apparatus of claim 51, wherein the electrode means comprises two or more RF electrodes connected to an RF energy source. 65． 51. The apparatus of claim 51, further comprising: a source of infusion medium coupled to the electrode means.

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