CN107847261A - For identifying and limiting the system and equipment of nerve conduction - Google Patents

For identifying and limiting the system and equipment of nerve conduction Download PDF

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Publication number
CN107847261A
CN107847261A CN201680016537.4A CN201680016537A CN107847261A CN 107847261 A CN107847261 A CN 107847261A CN 201680016537 A CN201680016537 A CN 201680016537A CN 107847261 A CN107847261 A CN 107847261A
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CN
China
Prior art keywords
equipment
probe
nerve
energy
working end
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Pending
Application number
CN201680016537.4A
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Chinese (zh)
Inventor
班吉姆·H·梅塔
詹姆斯·P·纽曼
斯科特·A·迈克基尔
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Siyn Medical
Serene Medical Inc
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Siyn Medical
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Filing date
Publication date
Priority claimed from US14/602,180 external-priority patent/US20160206362A1/en
Priority claimed from US14/602,187 external-priority patent/US9113912B1/en
Priority claimed from US14/602,196 external-priority patent/US9119628B1/en
Application filed by Siyn Medical filed Critical Siyn Medical
Publication of CN107847261A publication Critical patent/CN107847261A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1402Probes for open surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1477Needle-like probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4848Monitoring or testing the effects of treatment, e.g. of medication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4887Locating particular structures in or on the body
    • A61B5/4893Nerves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434Neural system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00666Sensing and controlling the application of energy using a threshold value
    • A61B2018/00678Sensing and controlling the application of energy using a threshold value upper
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00702Power or energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00839Bioelectrical parameters, e.g. ECG, EEG
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00892Voltage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002Irrigation
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

For finding one or more nerves and then interrupting the method and apparatus for improving accuracy during the transmission by the nerve signal of target nerve.Nerve through treatment can be rendered as that nerve signal can not be transmitted within the duration of selection, wherein such duration can based on the short time (such as, hour, day or week) or based on longer/permanent (for example, the moon or year).One embodiment of device includes accurate energy resource system, it is characterised in that the energy transfer element of nerve damage, suppression and the region of ablation can be produced with accuracy.

Description

For identifying and limiting the system and equipment of nerve conduction
The cross reference of related application
This application claims the senior interest of each in following patent application:U.S. Patent Application No. 14/602,180 Number;U.S. Patent Application No. 14/602,187 (is the U.S. Patent No. 9,113,912 authorized on the 25th of August in 2015 now Number);And U.S. Patent Application No. 14/602,196 (is the U.S. Patent No. 9,119,628 authorized on the 1st of September in 2015 now Number), each in above application was submitted on January 21st, 2015, and each of these applications passes through It is incorporated herein by reference.
Background of invention
The present invention relates to for improving the nerve signal for finding one or more nerves and then interrupting by target nerve Transmission precision method and apparatus.Nerve through treatment can prevent it from transmitting nerve letter within the duration of selection Number, wherein such duration can be based on the short time (for example, hour, day or week) or with longer-term/be permanently Basic (for example, the moon or year).One embodiment of device includes accurate energy resource system, it is characterised in that can accurately produce The energy transfer element in the region of neurotrosis, suppression and ablation.
Human nervous system is sent and received signal to pass on such as pain, heat, cold and the sensory information touched and control The command signal of muscular movement processed.In many cases, prevention, treatment and/or U.S. can be provided for individual by interrupting nerve signal Hold benefit.For example, (or transmission) external, undesirable or abnormal signal can be generated along nervous system pathways.For example, The nervelet at back shrinks the back pain that can cause extreme.Similarly, some neural compressings or other activation can trigger aobvious Or lasting pain.Some diseases may also damage neu (lining of nerves) so that nerve signal occurs certainly Into.This be spontaneously generated may cause various diseases, (in extreme circumstances) dead from epileptic attack to pain, or even. Abnormal signal activation may result in many other problems, including but not limited to twitch, spasm, epileptic attack, deform, take out Muscle, deformity (in addition to pain), other undesirable conditions or other pains, exception, undesirable condition, on social or body Unfavorable pain.
In some cases, the normal conduction of nerve signal can cause glabella line caused by 4 bad muscle, and this may lead Cause the permanent deformation of eyebrow (or forehead);Look like premature aging.Interrupting the nerve signal of superciliary corrugator muscle activation nerve can subtract The deformation of light eyebrow or forehead.
Traditional electrosurgery uses the monopole or bipolar devices for being connected to energy source.Monopolar electrode system includes small table Area electrode and it is placed in the refurn electrode that the opening position for separating and being spaced apart with small surface area electrode contacts with body.Return The size of telegram in reply pole is generally larger, and resistance or is capacitively coupled to body.Because same amount of electric current has to flow through each electricity Pole could complete circuit.Because refurn electrode generally has big surface area, the current density reduced allows heat more Dissipated on big surface area.In some cases, it is desirable to by refurn electrode be positioned at high blood flow region (such as biceps, Buttocks or other muscular or very vascular regions) so that the heat of any generation is promptly dissipated.Monopolar DC system An advantage be by monopole probes be precisely placed to need place and when needed optimization focusing electrosurgical energy energy Power.Resistance refurn electrode is general coated with conductive paste or jelly.If the contact with patient reduces or if jelly is dried, Areas of high current density is may result in, increases the possibility burnt at contact point.
The equipment that typical bipolar electrode system is typically based on the electrode with opposite polarity.Each electrode is connected to outside electricity Two of section's generator extremely in one.When applying electrosurgical energy, it is concentrated (and focusing) so that electric current is in battery limits Flowed between the electrode of opposite polarity in domain.Assuming that instrument will be limited by appropriately designed and use, caused electric current flowing In the target tissue of system between two surfaces.
Treatment for eliminating place between the eyebrows wrinkle includes the lifting of surgical operation forehead, the excision of superciliary corrugator muscle muscle, such as Guyuron, Michelow and Thomas are in nineteen ninety-five in the 691-696 of Plastic Reconstructive Surgery 95 In Corrugator Supercilli Muscle Resection Through BlepharoplastyIncision on page It is described.In addition, the motorial operation segmentation of superciliary corrugator muscle is used, and carried out in the following documents by Ellis and Bakala Description:Anatomy of the Motor on the 222-227 pages of J Otolaryngology27 in 1998 Innervation of the Corrugator Supercilli Muscle:Clinical Significance and Development of a New Surgical Technique for Frowning.These described technologies are that height is invaded Entering property, and it is sometimes temporary transient, because nerve regenerates over time, and need the operation for repeating or substituting.
Treating another less invasive operation of place between the eyebrows wrinkle includes botulinum toxin (Botox) being directly injected into flesh Meat.This produces flaccid paralysis, and in the The New England Journal of Medicine of 1991, and 324 the Obtain preferably describing in 1186-1194 pages.Although minimal invasive, this technology is predictably of short duration;So must It must be done again once every some months.
Hernandez-Zendejas and Guerrero-Santos describes via crosspointer bipolar DC system in the following documents Use the specific effort of RF energy:1994 in Aesthetic Plastic Surgery, 18:41 on the 41-48 pages Percutaneous Selective Radio-Frequency Neuroablation in Plastic Surgery.Author Describe the bipolar DC system using two parallel needle-like electrodes.Utley describes a kind of similar in the following documents with Goode System:Archives of Facial Plastic Surgery, the 1-3 months, 99, VI the 46-48 pages and U.S. Patent No. 6, Radio-frequency Ablation of the Nerve to the Corrugator Muscle in No. 139,545 for Elimination of Glabellar Furrowing.These systems obviously can not produce permanent result, it may be possible to Due to limitation intrinsic in crosspointer bipole arrangement.Therefore, as Botox, parallel pin electrode system usually requires periodically Repeat surgery.
Many modes be present active electrode is appropriately positioned near target tissue and determines if, close to nerve, to make It must treat and be limited on region interested.In numerous applications, therefore, to assure that nerve is positioned and is processed with the phase of establishing The effect of prestige, while minimize the collateral damage to surrounding tissue.It is especially true in cosmetic applications.
Various stimulation apparatus be made with it is patented.Disclosed in U.S. Patent No. 6,139,545 using double A kind of method of stimulation and the ablation of needle system.Stimulation can also negatively be implemented, wherein to stimulating unresponsive tissue quilt Ablation, as described in U.S. Patent No. 5,782,826 (mandate on July 21st, 1998).
Summary of the invention
The present invention relates to for therapeutic equipment to be positioned adjacent to nerve, stimulate nerve and then apply therapeutic treatment To damage the apparatus and method of the ability of neural traffic nerve signal.Especially, apparatus and method can be used for head and face In terms of cosmetic applications in region.However, these apparatus and method can be used for any position of body.
The disclosure includes the neural method in treatment tissue regions.One example of this method is included the work of equipment Navigated to as end in tissue regions;Wherein equipment includes stimulus modality and Therapeutic mode, and the stimulus modality includes at least first ginseng Number is set and the second parameter setting, and first parameter setting is stimulating nerve at the distance of working end first, and the second parameter is set Put is stimulating nerve at the second distance of working end, wherein the first distance is more than second distance, and equipment is configured as Stimulus modality prevents the activation of Therapeutic mode when being in the first parameter setting;Set under the first parameter setting with stimulus modality activation The standby stimulation with observation nerve;The working end of equipment is repositioned in tissue regions so that working end be moved to closer to Nerve;Equipment is reactivated under stimulus modality with the second parameter, with the stimulation of observation nerve, and confirms the working end weight of equipment New definition is into closer to nerve;And the activation equipment in Therapeutic mode, with it is predetermined treatment set under produce on First area for treatment of nerve, wherein activation equipment makes equipment replacement be the first parameter setting in Therapeutic mode.
This method is additionally may included in relative to mobile working end on neural direction to produce multiple treatments along nerve Area.In some variations, the working end of equipment is moved up in the side relative to nerve to be included controlling away from first along nerve Treat the working end for moving up equipment forwards in region so that the muscle associated with nerve can be during the stimulation of nerve It is stimulated.
The modification of this method includes the working end of location equipment and sent out in the case of not from site of puncture removing device The raw working end for repositioning equipment.Mobile device can be included in not in the case of the tissue regions removing device in multiple sides Equipment is moved up to increase the region of the stimulation for observing nerve.
This method can further include in the therapeutic mode before activation equipment at the first treatment region or near it Injecting narcotic.
Method and apparatus is additionally may included in the temperature that the skin surface on therapentic part is reduced before applying energy, And ice is held in position in during energy is applied.
In other modification, method is additionally may included in before insertion equipment using external neurostimulators with skin Upper mapping nerve anatomies, and use guide of the mapping as identification target treatment position.
In some variations, the first parameter setting is set including the first electric current, and the second parameter setting includes the second electricity Stream is set, wherein the second electric current, which is set, is less than the setting of the first electric current.First parameter setting can be fixed and/or the second parameter Setting can be adjustable.
This method is additionally may included under the first parameter setting with stimulus modality activation equipment to observe the stimulation to nerve, The motion on the surface including tissues observed region.This method is additionally may included under the first parameter setting to be set with stimulus modality activation The standby stimulation to observe to nerve, including pair at least one muscle associated with nerve perform electromyography.In addition, Under one parameter setting with stimulus modality activation equipment with observe to nerve stimulation including the use of measuring electrode measurement with nerve Electric pulse in associated at least one muscle.
In another example, the disclosure includes the neural method in treatment tissue regions.In a modification, the party Method, which is included at first position, navigates to equipment in tissue regions;Using being configured to apart from the first of the working end of equipment Set apart from the first of internal stimulus nerve and to apply energy to tissue regions at first position by equipment;Observe to nerve Stimulate;Using be configured to second of the second distance internal stimulus nerve apart from the working end of equipment set come by equipment the Two opening positions apply energy again to tissue regions, and wherein second distance is less than the first distance;Nerve is reappraised whether the Two set under be stimulated with determine the second place whether than first position closer to nerve;If the second place is closer to god Through then when observing using the second setting to neural stimulation, applying energy to nerve using the equipment to influence neural biography The ability of defeated nerve signal.
This method can be included in nerve apply energy after by equipment replacement be first set, this method also include will Equipment is readjusted to be set for second, and then refreshing in the second distance internal stimulus apart from the working end of equipment using being configured to The second of warp is set to apply energy again to tissue regions at subsequent position by equipment.
This method can also move up equipment in the side relative to nerve, to produce multiple area for treatment along nerve. Movement of the equipment on the direction relative to nerve can include along nerve in moving up forwards away from first position Equipment make it that the muscle associated with nerve can be stimulated during the stimulation to nerve.In other modification, not from thorn Occur equipment being positioned at first position and the second place in the case of wearing position removing device.
This method is additionally may included in mobile device in multiple directions, and before the second place applies energy again not From tissue regions removing device.This method is additionally may included in before applying energy to tissue regions, at first position position Injecting narcotic at or near the tissue regions at place.
In another modification, method can include the tissue regions for navigating to the working end of equipment at first position In, the equipment is configured as applying stimulation energy and applies treatment energy at the first position;Wherein when offer stimulation energy When, the equipment is can be configured with a setting in multiple settings, it is the plurality of set include at least first set and Second is set, wherein the stimulation area of equipment is larger when being operated under equipment is set first, and wherein equipment is configured as The application for the treatment of energy is prevented when equipment is set in first;Operation equipment under being set second;It is right in tissues observed region The reaction of the stimulation of nerve;When observing reaction, treatment energy is applied at least a portion of nerve, with by the way that energy will be treated Amount is applied to tissue regions to prevent neural traffic nerve signal, wherein after treatment energy is applied, the equipment replacement is the One is set;The working end of equipment is repositioned in subsequent opening position;Equipment is set from first and is adjusted to the second setting;Observation The subsequent reaction of stimulation in tissue regions to nerve;And when observing subsequent reaction, by applying treatment energy, Nerve is in subsequent position applies treatment energy at least at Part II.
This method can be included in moves up equipment to produce multiple treatment regions along nerve relative to the side of nerve.
In another modification, treating the method for nerve can include single longitudinal probe being inserted into tissue regions, Its middle probe is set including threshold value stimulating current, wherein preventing probe to be stimulated at threshold value stimulating current setting or higher than threshold value Electric current, which is set, applies treatment energy;Guide probe tip into nerve;It is related to nerve to trigger that stimulating current is conveyed by probe The muscular movement of connection;Stimulating current is set and is decreased below the setting of threshold value stimulating current so that the stimulation area of probe reduces; Probe in tissue regions is mobile towards nerve;Stimulate nerve to trigger the motion of muscle, and confirm that the position of nerve is being visited In the stimulation area of the reduction of pin;Apply electric current when observing muscular movement with heating nerve, wherein after electric current is applied, Stimulating current is set and is reset as being higher than threshold value stimulating current.
The disclosure also includes being used to treat the neural system in tissue regions, and the system includes:Probe, it, which has, is used for The working end being positioned in tissue;Controller, it is configured as providing electric power to probe with Therapeutic mode and stimulus modality;Wherein It is adjustable that the controller, which is additionally configured between multiple stimulations are set, and the plurality of stimulation, which is set, includes at least first thorn Swash to set to stimulate with second and set, and wherein the controller is additionally configured to prevent to apply in Therapeutic mode electric power unless setting It is set to the second stimulation setting;Wherein with compared with first stimulates the effective stimulus area for setting middle probe, stimulating and setting second The effective stimulus area of middle probe reduces so that the working end of probe must be set in stimulating and set second than being stimulated first In closer to nerve to stimulate nerve;And wherein controller is additionally configured to be reset to after applying electric power in Therapeutic mode First stimulates setting.
The system can include the anesthetic supply for the opening being fluidly coupled on the working end of probe.In some modifications In, it is fixed that the first stimulation, which is set,.Alternatively, or in combination, the second stimulation setting can be adjustable.
The system can be included in the energy transmission part on working end, and wherein energy transmission part is comprised at least in probe Upper longitudinally spaced the first current-carrying part and the second current-carrying part opened, the first current-carrying part and the second current-carrying part are by electric insulation material Material separates.
The modification of system can be included on working end and between the first current-carrying part and the second current-carrying part Fluid port.
In some variations, temperature sensor is between the first current-carrying part and the second current-carrying part.
The system is additionally may included in the light source on working end.Light source can include proportional to the amount of stimulation energy Modulation flash rate.
The equipment can also include the chamber (lumen) operationally set along the length of single shaft probe.
The disclosure also includes electrosurgery unit, and the electrosurgery unit is used for the stimulation energy with simulating and treating hypodermis Source is used together with treatment energy source and for being used together with the holder with flowable mass.For example, equipment can wrap Include equipment body;The probe of the part extension of slave unit main body, the probe are rigid so that the manipulation to equipment body is permitted Perhaps probe moves in tissue;Remote electrode at the working end of probe;It is positioned on probe and and remote electrode In the proximal electrode that nearside is spaced apart, wherein remote electrode and proximal electrode can be coupled to stimulation energy source and treatment energy source, The application of wherein treatment energy to remote electrode and proximal electrode is developed across the tissue between proximal electrode and remote electrode Damage in region;Fluid distribution sleeve (fluid dispensing sleeve) with one or more fluid ports, The fluid distribution sleeve is positioned between remote electrode and proximal electrode, and wherein at least one fluid port is oriented at and visited Controllable conveying of fluid material causes flowable mass to be directed into tissue regions on the direction of the axis vertical take-off of pin.
The equipment can also include fluid distribution chamber, and flowable mass is transported to by it from the point of probe in the axial direction In tissue.
The disclosure also includes being used for the system for realizing or performing treatment disclosed herein.Such system can include being used for The neural system in tissue regions is treated, it includes equipment and controller, and the controller is coupled to the equipment with working end, Wherein controller includes stimulus modality and energy transport model, and stimulus modality comprises at least the first parameter setting and the second parameter is set Put, the first parameter setting stimulates nerve at the first distance apart from working end, and the second parameter setting is apart from the of working end Nerve is stimulated at two distances, wherein the first distance is more than second distance, and wherein equipment is configured as stimulus modality and is in The activation of energy transport model is prevented during the first parameter setting;Wherein when the working end of equipment is positioned in tissue regions and When being activated under stimulus modality, controller provides energy to allow the stimulation to nerve under the first parameter setting;And work as The working end of equipment is repositioned in tissue regions so that working end is moved to closer to nerve and existed with the second parameter When being reactivated under stimulus modality, controller conveys energy to allow the stimulation to nerve and confirm that the working end of equipment is more leaned on Adnerval repositioning;And when equipment is activated in energy transport model, controller provides energy with true in advance Fixed treatment sets lower the first treatment region produced on nerve, wherein activation equipment thinks highly of control in energy transport model It is set to the first parameter setting.
Another modification of system includes being used for the neural system for treating the muscle associated with nerve, and the system includes: Single longitudinal probe including being coupled to controller, wherein single longitudinal probe is configured as being inserted into tissue regions;Control Threshold value stimulating current on device is set, and its middle probe, which is prevented from applying, is equal to or higher than the treatment energy that threshold value stimulating current is set Amount;Controller also includes stimulating current and set, and it allows to convey energy by probe to trigger the muscle associated with nerve Motion;Wherein controller, which is additionally configured to set stimulating current, decreases below the setting of threshold value stimulating current so that probe Area is stimulated to reduce;Wherein when stimulating current, which is set lower than threshold value stimulating current, to be set, nerve is stimulated to confirm by probe The position of nerve is in the stimulation area of the reduction of probe;It is low that treatment setting on controller is configured as stimulating current setting It is applied in when the threshold current on controller is set so that treatment, which is set, allows probe to apply electric current with heating nerve, wherein After probe is to treat setting application electric current, controller is configured as setting to reset to by stimulating current stimulating electricity higher than threshold value Stream.
System described herein can be included at least one injection port at the working end of equipment and for any The fluid of anesthetic or medicine is supplied.
System can include external neurostimulators, and it is configured as mapping nerve anatomies before equipment is inserted Onto skin, for use as the guide of identification target treatment position.
Can be by these system configurations into causing the first parameter setting to include the first electric current and set, and the second parameter setting Set including the second electric current, wherein the second electric current, which is set, is less than the setting of the first electric current.First parameter setting or the second parameter setting Can be fixed or variable.
The system can also include measuring electrode, wherein with stimulus modality activation equipment to observe under the first parameter setting The stimulation of nerve measures the electric pulse at least one muscle associated with nerve including the use of measuring electrode.
System, which may be configured so that predetermined treatment is set, includes predetermined temperature.
Any one in system can be configured so that the equipment or controller include manual override to allow when thorn Energizing mode applies energy transport model when being in the first parameter setting.
Above and other feature (including combination of the various novel details and part of construction and other excellent of the present invention Point) it is more particularly described now with reference to accompanying drawing, and point out in the claims.It should be appreciated that embody the spy of the present invention Determine method and apparatus to show by way of illustration, rather than limitation of the present invention.Without departing from the scope of the invention, The principle and feature of the present invention can be embodied as with multiple embodiments in various embodiments.
Brief description
From the following description with reference to accompanying drawing, method described herein, the foregoing end other objects of equipment and system, feature It will be apparent with advantage, wherein reference character refers to identical part in different views.Accompanying drawing is painted not necessarily to scale System, but focus on the principle for showing the present invention.
Fig. 1 shows the example of the equipment of the stimulation and the treatment that are arranged to nerve.
Fig. 2 shows another modification for the therapeutic equipment for being coupled to holder transfer member and controller/power supply.
Fig. 3 A show the modification of the working end of single shaft probe, and the single shaft probe has the band sensing for being placed on working end At least one the energy transmission range and/or fluid of device transmit port.
Fig. 3 B show another modification of the working end of equipment as described herein.
Fig. 3 C show the example for being placed equipment in the tissue, wherein energy transmission range and the generation damage in tissue Wound.
Fig. 4 A to Fig. 4 G show the use of the equipment and system as described herein when for being treated in patients.
Fig. 5 shows another feature of difunctional equipment, wherein therapy section of the fluid port in equipment in equipment / transmission material.
Fig. 6 A and Fig. 6 B, which are shown, produces therapentic part to realize the various other examples for the treatment of benefit.
Fig. 6 C show another example of the caused damage on the nerve of angle in a manner of as described herein.
Fig. 7 bipolar driving systems.
The bipolar pin schematic diagrames of Fig. 8 A.
Fig. 8 B separate the schematic diagram of bipolar pin (split bi-polar needle).
The enlarged side view of Fig. 9 A conical bipolar probes.
The enlarged side view of Fig. 9 B hollow chisel bipolar probes.
The Zoom Side of the bipolar probe (tapered conical bi-polar probe) for the taper that Fig. 9 C are tapered View.
The enlarged side view of the bipolar probe of Fig. 9 D separation tapers.
The schematic diagram of Figure 10 bipolar driving systems.
Figure 11 A do not utilize the ablative surgery of assist probes.
Figure 11 B utilize the ablative surgery of assist probes.
Figure 12 A are used for the side view of the hybrid bypolar pin of nerve ablation.
Figure 12 B are used for the side view of the hybrid bypolar pin of tumour ablation.
The side view of the auxiliary nervous probes of Figure 13 A.
Figure 13 B aid in the side view of double pointed terminal nerve probe.
The side view for the ablative surgery that Figure 14 is guided using auxiliary nervous probe.
The sampling of Figure 15 electrosurgical waveforms.
Figure 16 A-16B controllers and probe data library structure.
The side view of the ablative surgery of Figure 17 vision guides.
Figure 18 is the side view of the single shaft electrosurgical probe with equal surface region electrode.
Figure 19 is the side view of the single shaft electrosurgical probe for two electrodes that there are different surfaces to accumulate.
Figure 20 is the side view of the single shaft electrosurgical probe for two electrodes that there are different surfaces to accumulate.
Figure 21 is the side view of the single shaft electrosurgical probe with three electrodes.
Figure 22 is the side view of the single shaft electrosurgical probe with three electrodes and crank handle part.
Figure 23 is the side view of the single shaft electrosurgical probe with the multiple electrodes for crossing nerve.
Figure 24 is the side view of the single shaft electrosurgical probe with the multiple electrodes parallel with nerve.
Figure 25 is the side view of the single shaft electrosurgical probe with the multiple electrodes for passing through nerve at a certain angle.
Figure 26 is that the form for the treatment of energy scheme consistent with the present invention represents.
Figure 27 is that the figure for the treatment of energy scheme consistent with the present invention represents.
The detailed description of invention
Illustrated below is the example for the method and apparatus that invention described herein includes.It is contemplated that specific embodiment Aspect combination or specific embodiment combination in itself in the scope of the present disclosure.Although method described herein, equipment and System discussed (particularly for cosmetic purpose) according to for treating nerve, but the equipment of the disclosure, method and is System can be used for other needs part that accurately ablation or energy apply of body.
Present disclose relates generally to the following application being assigned:The Publication No. US-2005- that on June 17th, 2004 submits 0283148-A1 No. 10/870,202 application;The Publication No. US-2007-0060921-A1 that on July 28th, 2006 submits No. 11/460,870 application;No. 14/594,935 application submitted on January 12nd, 2015;On November 13rd, 2006 submits No. 11/559,232 of Publication No. US-2007-0167943-A1 application;On November 4th, 2009 Publication No. submitted US-2010-0114095-A1 No. 12/612,360 application;The Publication No. US-2013- that August in 2012 is submitted on the 8th 0046292-A1 No. 13/570,138 application;The Publication No. US-2010-0114191- that on October 23rd, 2009 submits A1, it is No. 12/605,295 application of U.S. Patent No. 8666498 now;On January 15th, 2014 Publication No. submitted US-2014-0180360-A1, present U.S. Patent No. 8938302 No. 14/156,033 application;And 2015 1 The 14/599th, No. 161 application submitted for 16th moon, the entirety of each of these applications are incorporated by reference into.
Fig. 1 shows an example of the equipment 100 for being configured as positioning and treating nerve.As described below, equipment 100 is Nerve can be identified and also transmit energy to disturb a part for the system of the ability of the transmission signal of nerve.In many situations Under, energy is by with the fuel factor to nerve.However, any treatment mode can be used in destroying the energy of neural traffic nerve signal Power.As illustrated, the modification of equipment 100 includes equipment body 102, it can be designed to alternatively meeting ergonomics Doctor is allowd to use fine technical performance correspondingly chucking device 100 and correspondingly place apparatus 100 and/or working end 104.Generally, such placement can be by balancing in tiger's jaw (web) in hand 2 or that hand 2 is between forefinger 4 and thumb 6 Equipment body 102 realize.However, apparatus and method described herein can include being allowed for any amount of of placement Configuration.In addition, the modification of the equipment allows to use such as robotic arm (robotic manipulator) and/or locator etc Automation placed.The modification of equipment 100 can include the feature for allowing operation or right hand operation.Alternatively, if Standby main body 102 can be that symmetrical permission left-handed operation or the right hand operate.
Fig. 1 also show the switch 112 on equipment body 102, and allow doctor easily and safely to stimulate mould Formula or Therapeutic mode start energy conveying.Equally, the modification of equipment can be included in the switch outside equipment body 102, such as Pedal, voice command or other trigger devices.However, the modification shown depicts rocker switch 112, wherein forward and to 114,116 wave or the movement of trigger switch 112 increases or decreases the intensity of stimulus signal afterwards.Therefore, the system shown in Fig. 1 And system as described herein includes the dual purpose system that can be operated under nerve stimulation pattern and ablation/Therapeutic mode.
As described below, doctor can adjust stimulation degree (that is, the scope that the nerve from equipment is stimulated) and triggering Stimulate, without mobile device 100 or move the slave unit of hand 2.Equipment body 102 can generally include three Operation switches (or the single switch with three positions.In institute's diagram, switch 112 lateral operation/position 114,116 and increase or decrease The stimulating current (or scope) of equipment.Center operations/position 118 starts stimulus modality.Once doctor located acceptable control Position is treated, doctor can start treatment energy transport model by the switch (for example, 152 or 154) by lower switch.In many In the case of, doctor can start Therapeutic mode by pressing pedal 152.This feature makes the inadvertent free of Therapeutic mode most Smallization.However, the modification of equipment is including the use of the optional switch 154 in equipment 100.In other modification, Ke Yicong Controller 150 triggers Therapeutic mode and/or continues operation triggering Therapeutic mode from switch 112.
The other modification of the equipment can using the either end trigger energy transport model of switch, and as scheme institute Show via the center of switch or single pedal activation stimulus modality.Alternatively, or in combination, (for example, 154) individually are switched The optional position that can be placed on equipment body 102.Fig. 1 shows that the sealing at before equipment body 102 1/3 is shaken Arm switch 112.Such configuration allows easily to carry out operation processing using the forefinger or thumb of doctor.Furthermore although diagram What is gone out is rocker switch, but other single switch, multiple switch and/or multifunction switch pattern are also suitable for realizing the present invention This aspect.
Fig. 1 also show the working end 104 of the equipment 100 including single shaft probe.Although example as shown below includes electricity Electrosurgical energy mode, but other energy modalities can also be applied in combination or instead of electrosurgery mode.For example, this mode can wrap Include:Cooling, low temperature, hot RF, heat (resistance heating), microwave, focusing or non-focused ultrasound, heat or non-thermal DC, UV, radiation and its appoint What is combined, available for the ability for reducing or otherwise controlling neural traffic signal.Fig. 1 schematically shows equipment 100 It is coupled to power supply 150, power supply 150, which can provide, performs the energy modality needed for treatment and the stimulation energy for positioning nerve Amount.Other modification considers single power supply (not shown) and stimulation energy is powered/controlled.In other modification, Handle 100 can include power supply.Term power supply is intended to include the unit of the wherein conveying of energy of the controller regulation from power supply. Therefore, power supply 150 described herein can include controller.Alternatively, controller can include single physical location.
Equipment as described herein can also provide physicians with feedback using various features.For example, show can be to by Fig. 1 Doctor provides the feedback indicator of feedback.Feedback can be vision, tactile, vibration, audio or its combination.It is although shown Modification shows the feedback indicator 120 of the distal end of ancillary equipment main body 102, but the modification of equipment allows that equipment can be located at Indicator in 100 any part and/or in equipment multiple positions.Feedback can include generator state, treatment Number, equipment whether target nerve or ablation site tolerance interval in instruction.
Fig. 1 also show the exemplary operation end 104 of equipment 100.As discussed herein, working end generally includes to have Distally 106 single shaft probe 105.In some variations, distal end 106 includes being used to allow working end 104 to be penetrated into tissue Tip.Alternatively, distal end 106 can include blunt shape, and it allows working end 104 to be penetrated into tissue, but minimum pair The undesirable collateral damage of tissue.Working end 104 also includes one or more energy conveyor zones 106,108,110.Example Such as, when energy modality includes electrosurgery unit, working end 104 can include being electrically isolated from each other into a bipolar fashion or unipolar fashion Make one or more electrodes 106,108,110 that electric current passes through.
Any probe disclosed herein can include light source 107, such as optical fibre illumination, light emitting diode, for aiding in Doctor is identified by the lasing light emitter of the position of the working end of the transcutaneous placement of tissue.Light source can pass through controller/power supply 150 Power supply, or can be powered by the source in equipment body 102 itself.
Fig. 2 shows another modification for the therapeutic equipment 100 for being coupled to holder transfer member 170.The equipment can be with It is coupled to other connectors of controller/power supply 150 including cable 122 or by equipment 100.In shown modification, connector Including hub 124.However, optional modification allows the equipment 100 for being directly wired into controller 150.Shown in Fig. 2 Holder 170 is also portrayed as single syringe by modification.However, the optional modification of equipment includes the line concentration by equipment 100 Device 124 or cable 122 are fluidically coupled to the holder of working end 104.In this case, there will be to material in holder Flowing pressurization or start means.Holder 170 is typically fluid source, but the particulate of modification including injectable, gel or its Its nonfluid injectable materials.Any kind of fluid can be transported to the working end 104 of equipment 100 by holder 170.Institute In the example shown, holder 170 includes the syringe with piston.Optional modification includes being coupled to electronics or point of automation The holder of orchestration.
Generally, the material in holder 170 includes aesthstic solution (aesthetic solution), cooling solution, conduction Fluid, medicine, enamel and/or any other bioactivator.The modification of apparatus and method is multiple including being conveyed by equipment Material or to target position.For example, salting liquid can be transported to target position to adjust the impedance of tissue, while enamel can be Conveyed before, during or after conveying salt fluid.As described below, holder 170 connects with the port flow at working end, To allow the trandfer fluid at or near therapentic part.Material can be allocated at any time, including during tissue penetration, During being moved in tissue, and before stimulating and/or applying energy/period/afterwards.Material can be every sub-distribution by Volume is controlled, or can be based on doctor's preference and the adjustable volume distributed.In addition, distribution can before treatment, period Or automatic generation afterwards.
Controller/power supply 150 is also shown as with visual displays 150 by Fig. 2.Visual displays can provide to doctor Treat information and facility information.For example, system can provide the information on application for the treatment of number;System can provide on Treatment whether successful information (for example, target site whether keep predetermined temperature and continue for how long).System is also Information about the temperature and time curve for treating every time can be provided.For example, in a modification, controller includes more Individual predetermined selectable treatment sets (for example, 80 degrees Fahrenheits, 70 degrees Fahrenheits and 85 degrees Fahrenheits), and attempts therapy section Position is kept the predetermined time (such as 30 seconds) at these tem-peratures.In some variations, doctor can be based on target site Whether position or skin at target site are very shallow or thin and determine to use any setting.Controller can also be established Cut-off temperature, then stop treating higher than the cut-off temperature.In one example, cut-off temperature is 93 degrees Fahrenheits, but up to 130 Degrees Fahrenheit).Controller can also check temperature over the course for the treatment of, and if temperature rise is not observed, then controller can To stop treating or a small amount of electric power can be applied.Other safety measure can be used, such as passes through multiple medium temperatures Foundation is progressively risen progressively to target temperature (for example, each unit interval is higher than body temp x degree, until reaching target temperature).This Outside, system can monitor impedance and establish maximum impedance when treatment stops.In one example, the system can monitor 100 Impedance between ohm and 500 ohm, wherein impedance when closing is about 2000 ohm.
Modification shown in Fig. 2 also includes equipment body that is as described above contoured or meeting ergonomics 102, it is applied to the equipment 100 of one-handed performance, and wherein equipment body 102 is equilibrated at the hand of user between thumb and forefinger In tiger's jaw.This place allows user that single finger is placed on switch 112 with forward 116 direction or backward 114 Direction on activation switch 112 come adjust the stimulation of system set.As described above, in some variations, forward 116 and backward 114 movements allow the stimulus intensity of adjusting device 100, and when suitably identifying target position, the finger of user can select Trigger 118 is to apply stimulation energy to identify nerve.Once doctor recognizes target site, doctor can operate any amount of Switch 152,154 and combination discussed above are to start to treat desired tissue regions.
Fig. 3 A show a modification of the working end 104 of single shaft probe 105, and the single shaft probe 105 has at least one Energy transmission region and the sensor and/or fluid delivery ports being placed in working end 104.Modification shown in Fig. 3 A Including first or distal energy transmission region 122 and near-end transmission region 124.For example, two energy transmission regions 122,124 can The electrode of opposite polarity during including the use of RF energy sources.As illustrated, two electrodes 122 and 124 may be positioned so that it Extending through limit with holder (as shown in Figure 2) fluid communication fluid conveyor chamber sleeve 130 or similar knot On the either side of the delivery port 132 of structure.Alternatively, sensor 126 (such as detector unit) can be placed adjacent to Energy transmission region 122 and 124.
Configuration shown in Fig. 3 A allows the fluid in central area and/or material being transported to expected target region.Should Equipment can include any amount of fluid port 132, including multiple from single fluid port to circumferentially being placed around equipment Or it is only limitted to the one side of equipment.The modification described in Fig. 3 A shows multiple fluid ports 132, its be oriented at relative to Flowing is guided in the radially outward direction of the central axis of single shaft probe 105.Port 132 is disposed close to energy transfer list One of member is advantageous in that material can be delivered directly to the tissue regions of targeting during operation.
Fig. 3 B show another modification of the working end 104 of equipment as described herein.In the modification, energy transmission region 122nd, 124 by non-energy transmission region 130 and for the circular passage in probe 105 be opening fluid delivery ports 132 Separated.Fig. 3 B also show one or more sensor elements 126 can be placed in energy transmission region 122,124 it Between.In some variations, sensor element 126 will be positioned in outside the flow path of port 132 so that leaves port 132 Material do not influence the reading of sensor 126.
Fig. 3 C show the example for the equipment 100 being placed in tissue 10, and wherein energy transmission region 122 and 124 is in group Knit and damage 12 is produced in 10.This graphically depict application of the RF electric currents 136 between two regions 122,124, however, as above Pointed, it can apply and result in the damage on energy transmission region 122 and 124 or any energy of area for treatment 12 Mode.The example described is shown after doctor is identified for the appropriate location for the treatment of (to be used for example, being identified in stimulus modality After the correct position for the treatment of) state of equipment 100 is shown.Fig. 3 C also show by the defeated of the material 134 of port 132 Send.In shown modification, port 132 allows material to be delivered up in the side of the axis radially away or perpendicular to probe 105. As discussed above, configuration in addition is defeated in the scope of the present disclosure, including on the different directions being oriented in identical equipment Send the combination of the port of material.Anyway, the material can be conveyed before, during or after treatment mode is applied. In addition, the placement of neighbouring transmission region 122 and 124 or the port 132 between transmission region 122 and 124 allows to have material It is transported to area for treatment to target.
For example, in cosmetic applications, it may be necessary to convey numb agent (numbing agent) to region.In such case Under, once doctor determines the correct placement of the working end of equipment, numb agent can be transported to by doctor from holder by port Tissue regions to be treated.Port and the close amount for allowing to minimize the material that must be conveyed of target region.Minimize fiber crops The amount of wooden agent and/or diffusion are desired, because numb agent may damage the ability that muscle is reacted to nerve stimulation.
As described herein, equipment can include any amount of energy modality to provide therapeutic treatment.Therefore, in Fig. 3 A RF energy electrodes are not limited to the energy transmission region 122,124 shown in Fig. 3 B.In other modification, region can include Cooled region, cryogen, hot RF, resistance heat heating region, microwave antenna, focusing or non-focusing ultrasonic transducer, by DC Electric current, UV, radiation and the hot surface of any combination of them power supply.In these modifications dependent on source of radio frequency energy, two Individual energy transmission region 122,124 may include the electrode of opposite polarity.The type of energy used in, it may be desirable that Be that sensor 126 (or other sensors) is placed between transmission region 122,124.However, alternatively, or additionally, one Individual or more sensor can be placed along any other part of probe 105 or equipment.
Fig. 4 A to Fig. 4 G show the use of the equipment and system as described herein when for being treated to patient.Institute The example shown show using equipment 100 melt control facial muscle movements nervus temporalis one or more regions and/or Branch.It will be appreciated, however, that method described herein, feature and aspect can apply to control any observable/measurable Any neuromechanism of body function.
Fig. 4 A are intended to show that the feature of the system similar with the system being discussed herein, and wherein therapeutic equipment 100 can be to carry Operated for the dual purpose pattern of nerve stimulation and therapeutic treatment.In a modification, work of the stimulatory function in probe 105 Delivery of pulses direct current between energy transfer surface 122,124 in end 104, to be operated under nerve stimulation pattern.In addition Modification in, nerve stimulation pattern can provide the alternating current electric current of generation (or RF) to identify nerve, such as ability via muscle Known to field technique personnel.Anyway, when with stimulus modality in use, the working end 104 of equipment 105 to tissue apply electric current To stimulate the nerve for the motion for producing the muscle that nerve is controlling.This motion can be physically observed (for example, logical Cross the motion for feeling muscle) or be visually observed (for example, when doctor stimulates and observe which facial muscle or which During componental movement).In addition it is possible to use any amount of pacing devices or camera apparatus move to detect.
Equipment 100 can operate in the multiple settings for stimulating nerve.As long as the working end of equipment sufficiently closes to nerve, its Distance depends on the parameter (for example, amplitude of the magnitude of current or electric current) of the electric current applied.The circulation of electric current causes the contraction of muscle And relaxation, this can be observed by doctor or other sensing/identification devices.Electric current can be adjusted from probe body or from controller Amplitude.The intensity of stimulation and the amplitude of electric current and directly related with the motorial degree of approach.As doctor is closer neural, He/her can reduce stimulating current amount, and still observe contraction of muscle.When stimulating current it is low (《.7mA) and observe flesh When meat shrinks, probe electrode is close to target kinesitherapy nerve.In a Working Examples, low stimulating current (for example .7 milliamperes) is found Nerve stimulation is produced in the 2mm of the working end of equipment.Known device allows system to apply in the certain limit of nerve can The energy to work within the range.
For example, in present exemplary, if stimulating nerve/muscle using threshold value stimulation energy (for example, low stimulating current), Then doctor and/or sensing identification device will confirm that the working end of equipment is placed in the coverage/model of target tissue (for example, nerve) Apply treatment energy in a controlled manner in enclosing, without producing the group of undesirable subsidiary injury or encirclement far beyond target tissue Knit.In a modification, system is allowed to apply stimulation energy using the stimulation of threshold value stimulation energy/electric current, while convey treatment Energy simultaneously maintains the predetermined predetermined time quantum of goal treatment constant temperature.Doctor and/or sensing identification device will Confirm to have reached effective treatment end points on target tissue (i.e. neural).It should be appreciated that the design of electrode or area for treatment also may be used To influence the scope of equipment (including lesion size, shape, volume and thermoisopleth).After kinesitherapy nerve is positioned, pass through identical Electrode applies RF energy to heat tissue and suppress nervous function.Once RF damages are placed on nerve, then brain and flesh Nerve exchange between meat is interrupted, and patient can not activate muscle again.
Fig. 4 A represent the influence of two parameter settings under stimulus modality.Under the first parameter setting, equipment 100 can be with Nerve in stimulating tissue at the first distance 142.In the second parameter setting, equipment 100 stimulates nerve at second distance. As shown in Figure 4 A, the first distance is more than second distance.This function allow doctor under the first parameter setting operating system with total Target nerve is positioned on body.In order to which the working end 104 of equipment 100 is placed closer into target, doctor changes to be set to the second parameter Put, and check the contraction and relaxation of the muscle by target nerve control.Because the field stimulation 140 of equipment 100 is restricted, The stimulation of target muscle confirms working end 104 close to the target site on nerve.If doctor operates under the second parameter setting Equipment 100 and any muscular movement is not observed, then doctor will be appreciated by working end and not put most preferably relative to nerve Put.It is apparent that system can include any number of parameter setting.In addition, the purpose that scope 140 and 142 is merely to illustrate. In one Working Examples, the second parameter area is about .7 milliamperes and corresponds to the scope 140 less than 2mm.Furthermore Ke Yigen Come adjusting parameter level and scope according to application, tissue regions, required stimulation degree etc..In another modification of equipment and system In, controller/power supply (and/or equipment 100 feature of itself) prevents equipment from operating in the therapeutic mode, unless equipment is switched to Corresponding to the second parameter setting compared with pinprick scope 140.
In another modification, it is not the preference pattern for applying therapeutic treatment that system can provide stimulus modality to doctor Warning, rather than prevent apply treat.Therefore, system can require that doctor carries out override so that doctor is purposefully controlled Treat sex therapy.
Fig. 4 B show nervus temporalis branch 14 and access point 20, and the probe 105 of its traditional Chinese physician's puopulsion equipment 100 is with by probe It is placed on below skin and neighbouring target is neural.As discussed herein, variant of the invention can be come most using single shaft probe Smallization enters wound 20 and accurately tracked along neuropeptide 11 4.In optional modification, multiaxis probe can be utilized and begged for herein The parameter function of the change of opinion is used.
Fig. 4 C show that the working end 104 of equipment is advanced by accessing opening 20 towards neuropeptide 11 4.As illustrated, equipment can To be operated in the first parameter setting so that stimulate distance 142 to be enough to allow doctor generally to position be responsible for specific muscle Nerve.Opening 20 is not limited to the position of diagram.Probe can enter any part of body as needed.
During the process that probe is placed, stimulating current level can be one or more in equipment by pressing successively Increased or decreased as switch is described (referring to fig. 1 above and Fig. 2).The loudspeaker associated with system can launch tool Have volume or frequency tone or to the amplitude of the stimulating current of each switch closure set substantially proportional other sound and/ Or perceptual property.This feature allows operational staff to adjust irritation level, without adjusting any level associated with generator Driver plate or switch, so as to allow operational staff to be absorbed in the probe placement of key.
In a modification, when doctor position neuropeptide 11 4 when, doctor can by system call interception to the second parameter setting, so as to Reduce field stimulation 140.As illustrated, work as the energy that the stimulation of neuropeptide 11 4 in the second parameter setting will notify doctor working end Transmitting portions are close enough, close to and/or the desired target region 30 of contact.
Fig. 4 D represent the field stimulation 140 reduced in the second parameter setting during operation equipment.Observing muscular movement When, the switch that doctor can apply treatment energy/treatment (as described above) by operating enters system without mobile device Therapeutic mode.Once being in Therapeutic mode, target region 30 can be melted or otherwise be handled to doctor.As described above, because The stimulation of target nerve occurs when using threshold current, so system can predefine by applying known action to tissue Amount treatment energy (controlling specified temp as described above and/or time) come carry out nerve treatment.In some variations, The energy of predetermined amount is set to ensure threshold value field stimulation of the therapeutic effect without departing from equipment (that is, when using threshold value energy The scope of equipment during amount, for example, Fig. 4 A scope 140).
In other modification, system can use the setting that contraction of muscle or stimulation are produced during treatment energy applies To handle target region 30.Therefore, doctor can observe the stimulation of associated muscle during treatment.In this modification, when During associated muscle stop motion, doctor can confirm that treatment.It is believed that when being depolarized the nerve of muscle weakness, muscle Twitch occur.If frequency is sufficiently low (for example, 60Hz), then nerve can be depolarized directly.
Fig. 4 E depict doctor and promote working end 104 along neuropeptide 11 4 by identical opening 20, and further depict and be The reduction with the second parameter setting is readjusted or are switched to automatically to another feature of system, wherein equipment and/or controller/power supply Opposite the first parameter setting corresponding to larger field stimulation 142 of field stimulation 140.As described above, in some variations, When system is in the first parameter setting, system prevents the use to applying therapeutic treatment.In some variations, system can only Apply therapeutic treatment in the second parameter setting.One of this feature is advantageous in that, by equipment from the first therapentic part 30 Parameter setting must be readjusted as the first parameter setting for certain towards the doctor of the second therapentic part 32 movement, to ensure The close enough purpose nerve of energy transfer surface and/or target site 32 of working end.Fig. 4 F show equipment 100, its traditional Chinese physician Reselect the second parameter setting corresponding to the field stimulation 140 reduced.Once doctor is by identifying that associated muscle is transported Move and carry out place apparatus, doctor can then apply therapeutic treatment in the case of not mobile device.As illustrated, the second place 32 Along closer to the distal side of position 30 the neural virtual longitudinal axis.This " near-end to distal end " orientation along the longitudinal axis of nerve disappears Melt the effect for being considered as improving the treatment duration.
Fig. 4 G show its traditional Chinese physician identification and the modification of the treatment operation for the treatment of are produced at three positions 30,32,34.For For the sake of clear, the figure shows the working end 105 recalled by access point 20.Also shown is the probe on double hair ways Specific characteristic, it is provided to being caused in the neurological region of identical nerve or the one or more of muscle for needing to treat in control The ability of multiple damages 30,32,34.In the example shown, doctor causes initial damage 30.This initial damage destroys and nerve Exchange, but keep complete from damage 30 to the pars nervosa point of muscle (being represented by region 22).This complete area of nerve Doctor is allowed to be continuing with the stimulatory function of probe, with by a distal direction (that is, in the close muscle region along nerve On 22 direction) traveling probe further stimulates the motion of muscle region 22.The movement of equipment by this way allows to cure Equipment is accurately repositioned at upper (or the different nervous ramifications for the muscle for needing to treat in control of identical nerve by teacher On).As long as probe tip distad advances from initial damage along nerve (towards muscle), doctor's can is by as above being begged for The stimulation and observation of opinion positions nerve.In the example shown, damage and produced with three continuous process, i.e., by initial damage 30, Next damage 32 and final damage 34 are formed continuously.As long as probe damages away from last, stimulus modality may result in flesh Meat shrinks.
The process that nerve is repositioned and applies multiple damages to single nerve can be applied, to ensure the long-term for the treatment of Effect.In view of before it can relay signal nerve must be healed in three opening positions, along identical nerve (or identical Neurological region) multiple damages add life-span of effect.Multiple longevities for damaging the duration for being believed to be helpful in treatment, Because nerve is considered as being healed by near-end to distal end.Mean that nearest neurotrosis (for example, 30) will be likely to heal, it is allowed to Re-establish and exchange along nerve before the neurotrosis (that is, 32 and 34) of more distal end.
In another modification, as shown in Fig. 4 A to Fig. 4 G, for causing the method for multiple damages to include on same nerve Using outside stimulus equipment and map neural position to obtain the rough instruction of nerve location.Then doctor visits probe or equipment Pin inserts tissue.Then doctor positions target nerve using stimulatory function.In modification, stimulatory function is set to increase The parameter setting of the field stimulation of equipment, but also prevent equipment start (firing) it is therapeutic/ablation.Then doctor will Stimulating current is adjusted to pinpoint nerve, and confirms contraction of muscle.Assuming that stimulation parameter is arranged to reduce the thorn of equipment Swash scope and doctor is by the placement of observation confirmation probe, then doctor then can be with the Therapeutic mode of starting device (for example, logical Cross and apply energy to influence the ability of nerve/organizing transmission nerve signal or ablation nerve/tissue).In some variations, system Automatic first parameter that resets to is stimulated into setting, which increase the field stimulation of equipment and prevents equipment from swashing in the therapeutic mode It is living.Next, probe alternatively can be advanced to the new position away from initial damage by doctor, and by repetitive stimulation and control Treat.Doctor can repeat subsequent treatment as desired along nerve, to produce any amount of damage.
The modification of equipment includes at least three parameter settings, and two of which parameter setting corresponds to bigger than the 3rd parameter setting The field stimulation reduced greatly.In this case, the parameter settings of two reductions can correspond to the first tolerance interval and the Two finer scopes.Such set will allow the accuracy of doctor in various degree to come relative to nerve positioning equipment.
Fig. 5 shows another feature of difunctional equipment 100.In the modification, the fluid port in equipment is being set Material 134 is conveyed between standby treatment part 122,124.In this example, material include anesthetic or numb agent with produce by The effective coverage 44 of limitation (as shown in Fig. 5 dash area).One of this configuration is advantageous in that, applies over larger areas The ability for adding numb agent to could potentially interfere with nerve stimulation muscle.Therefore, if numb agent influences nerve so that it is no longer able to Muscular movement is triggered, or if can not be stimulated away from the neural region of the first therapentic part, then the validity of the operation It may be damaged.The modification of operation conveys numb agent before, during and/or after being included in application therapeutic progresses.In some situations Under, contracted muscles because doctor may require patient, it is therefore desirable for be patient maintain motion control to the muscle treated.Flesh The contraction of meat allows doctor to determine the progress treated.In this case, because patient can not shrink his/her muscle, because This may not expect to cover face or muscle with anesthetic.<The example of numb agent includes dilution lidocaine %1 or 2%, had Adrenergic lidocaine and Articaine (septocaine).However, it is possible to use any numb agent.
Fig. 6 A and Fig. 6 B, which are shown, produces therapentic part to realize the various other examples for the treatment of benefit.Fig. 6 shows One damage 30 is on the near-end of nerve or main split, and the damage 34 of the second damage the 32, the 3rd and the 4th damage 36 are in neuropeptide 11 4 In different branches.As described above, the order of ablation site is based on near-end to distal direction (for example, away from insertion point, or direction Muscle).Fig. 6 B show the example for treating multiple horizontal nervous ramifications.As shown in Figure 6B, the modification of operation includes applying damage It is added on main neural " transverse direction " branch close to muscle.Intended effect can be by putting on nervus temporalis by single damage Multiple nervous ramifications realize suppression nervous function, so as to eliminating the high power face line (wrinkle) as caused by muscle activity.Though The first damage 30 being so not required is placed adjacent to access point 16 and off-target muscle is farthest, but the second damage 32 is away from the One damage 30 is formed, and the 3rd damage 32 is formed away from the second damage 32, wherein each damage be in nervus temporalis not In same branch 17.
Fig. 6 C show another example of the caused damage 30 on the nerve of angle in a manner of as described herein.As above institute State, disclosed method and equipment can produce in any amount of region of body and along any number of nerve.
The optional modification of Fig. 7 bipolar driver systems.
Two of Fig. 7 identifying systems required component, various modules and option.Two groups always used during operation Part will be power generator/controller/data storage device 400 and probe 371.400 include advanced electronic system, and it can know The probe of other proper authorization, prevent from reusing the probe used in the past, generate appropriate energy as described above, perform safety inspection Look into, data storage and other described functions.400 major function can include but is not limited to the generation of light, position thorn Swash the generation of electric current, the generation of ablation energy, data record, storage, communication and retrieval and to MIS operation it is vital its Its function.Probe 371 and its various forms are that single punctures bipolar surgical instrument, and it can be used for identifying its sophisticated 301 phase The correct position for the target tissue 101 for being ablated to, changing or destroying for expectation.Probe 771 and its various derivatives can be with optional Ground is used for auxiliary positioning and is properly positioned the tip 301 of probe 371.
The isometric views of Fig. 8 A and Fig. 8 B bipolar probes.
Bipolar probe 310 represent the probe 371 in addition to the needle point type on probe shown in Fig. 9 A-9C, 372, 373.Fig. 9 D are different with other because it has separation to return to probe (split return probe).Bipolar probe 310 (being not drawn on scale) is made up of insulation dielectric body 309, and insulation dielectric body 309 is made up of suitable bio-inert material (such as Teflon, PTFE or other insulating materials), cover the electrode in addition to wherein electrode 302 exposes as refurn electrode 302.The pipe of conductive return electrode 302 is made up of medical grade stainless steel, titanium or other conductive materials.Hollow or solid conductive tip electricity Pole 301 protrudes from the dielectric insulator 305 of surrounding.Size (diameter, the length of 309,302,305 and 301 and its chamber can be adjusted Degree, thickness etc.), to allow to cause such as to apply the different surface regions of required certain current density for particular treatment.
Coreless armature 301 is commonly used as syringe to convey the medicine of such as local anesthetic.Point electrode 301 is via resistance Anti- matching network 418 (Figure 10) is connected to power amplifier 416.Refurn electrode 302 will return to electricity via impedance matching network 418 Stream is conveyed to power amplifier 416.Dielectric insulator in the disclosed embodiments is used as the transparent of light pipe or fiber optic cables Medical grade polycarbonate.Light source led or laser 408 (Figure 10) are via fiber optic cables/transparent dielectric 305 in the distal end of probe Place provides illumination, for guiding probe, i.e., shallow operation under the skin.In an alternate embodiment of the invention, dielectric insulator is replaced It is multiple optical fiber for observing and illuminating, as Figure 12 A are instructed.
Ablation areas 306 and 140 radially extends generally along electric field line around electrode 301.For very close skin 330 Operation, there is a possibility that to burn in region 306.In order to minimize the possibility burnt, separation is provided in Fig. 9 D and is returned Electrode catheter 374.So as to which electric current be concentrated away from region 306 to 140, vice versa.In fig. 8 a, insulator 307 will return Telegram in reply pole is divided into two parts 302 and 303, return current ratio is divided into from 0-50%, this can also be selectively activated. Active electrode is also divided into two parts 301 and 311, therefore can be along desired direction guide energy.This electrode configuration quilt It is identified as on the proximal part of probe, therefore operator can correspondingly place pin and electrode.Figure 12 A teach laser orientation Ablation is conveyed with obtaining more accurate energy.
Fig. 8 A separate the isometric views of bipolar probe.
Bipolar probe 380 (being not drawn on scale) is separated the suitable biologically inert material of refurn electrode 302 and 303 by covering Insulation dielectric body 309 made of material (such as Teflon PTFE or other electric insulations) forms.Disclosed conductive return electrode 302 and 303 are made up of medical grade stainless steel, titanium or other conductive materials.The hollow or solid He of separation conductive tip electrode 301 311 protrude from the dielectric 305 of surrounding.Operation and the probe pinpoint taught in Fig. 9 D of hollow/separation conductive tip Hold 310 closely similar.Ablation areas 1203 (Figure 10) and 140-144 are generally radially extending along electric field line around electrode 301. Operation for very close skin 330, there is a possibility that to burn in region 306.In order to minimize the possibility burnt, make With refurn electrode probe 311 is separated, so as to which electric current be concentrated away from region 306 to 140.For wherein nearby structure 111 is deposited In the operation of risk, ablation areas 1203 must be non-radial ablation areas.Disclosed separation electrode 380 allows to divide or divided From the energy for being transported to electrode pair 301/302 and 311/303.Disclosed division or paired ratio are 0-100%.Positioned at electrode pair Between dual amplifier or time division multiplexing/switching main amplifier 416 energy be directed to target 101 avoid 111.It is this simple Switching network reliably quantitative proportioning electric energy, while minimize the injury to neighbouring structure.
Fig. 9 A conical bipolar pins.
Bipolar probe 371 discloses the conical electrode 301 and tip 351 for minimally invasive single-point entrance.Probe diameter 358 Similar to No. 20 (20-gage) or other small syringe syringe needles, but according to application, required surface area and required penetrate Depth, can be with greater or lesser.In the disclosed embodiment, 302 long 30mm of electrode axis, wherein about 5mm is on-insulated.Both Length and surface area can be modified to meet various applications, such as aesthetic surgery or elimination back pain.Conduction returns Electrode 302 is made up of medical grade stainless steel, titanium or other conductive materials.Dielectric insulator 305 in the disclosed embodiments is The transparent medical grade material of such as makrolon, it can also serve as (double as) light pipe or fiber optic cables.High-intensity light source 408LED/ lasers (Figure 10) provide guiding illumination 448 at the working end of probe.Light source modulation/flash rate is with receiving Stimulating current 810 it is proportional, as Fig. 8 is instructed.Minor diameter electrode allows the Minimally Invasive Surgery generally carried out with local anesthetic. The configuration can include the chamber for being used for conveying medicament, such as described elsewhere.
Fig. 9 B hollow chisels.
Hollow chisel electrode 352 is typically used as syringe to convey medicine, such as local anesthetic, medicine/tracer dyestuff. Hollow electrode can also extract sample.Dielectric insulator 305 in the disclosed embodiments is transparent medical grade polycarbonate, and And perform and be used as light pipe or fiber optic cables.Novel dual purpose dielectric reduces probe diameter and manufacturing cost.Light source 408 (being usually LED or laser (Figure 10 is not shown)) provides illumination 448 at the working end of probe.It is provided under the skin Face guides the light source of probe.Second embodiment, as Figure 12 A are instructed, dielectric insulator be replaced by multiple optical fiber or with this Multiple optical fiber combinations are for observation/illumination.
The taper that Fig. 9 C are tapered.
Bipolar probe 373 discloses the tapered probe being tapered for minimally invasive single-point entrance.It is similar to such as Fig. 3 A The probe 371 instructed is constructed.Probe tip is not necessarily to scale to instruct tip geometry.In disclosed implementation In example, electrode 301 is about 5mm, and is made up of medical grade stainless steel, but can have various length to adapt to concrete application and table Area requirements.The solid conductive tip electrode 353 being tapered protrudes from the dielectric insulator 305 being tapered.Transparent dielectric Insulator 305 performs also as the light pipe or fiber optic cables that terminate at the high-intensity light source 408 (Fig. 7) for providing illumination 448.Electricity Pole component, which is arranged on, to be met in the handle 388 (it is not drawn on scale) of ergonomics.Handle 388 keeps ablation connection/pass Disconnect and close 310, ablation/stimulus modality switch 367, identification module 331 and terminal (Figure 73) for cable 1334.TEMP Device 330 (is located at close to tip) monitoring tissue temperature.
Fig. 9 D separate conical bipolar probe.
The description of the probe is described in Fig. 8 B and Fig. 9 D.Bipolar probe 374 (being not drawn on scale) is separated by covering Insulating dielectric 309 made of the suitable bio-inert material (such as teflon) of refurn electrode 302 and 303 forms.It is conductive Refurn electrode 302 is made up of medical grade stainless steel, titanium or other suitable conductive materials.Hollow or solid separation conductive tip electricity Pole 301 and 311 protrudes from the dielectric insulator 305 of surrounding.Their operation is very similar to the probe pinpoint instructed such as Fig. 8 A End 380.The solid conductive tip electrode 311 and 301 being tapered protrudes from transparent dielectric insulator 305.Dielectric insulator 305 Also performed as light pipe or the fiber optic cables that the high-intensity light source 408 for illuminating 448 is provided with terminating at.
Probe handle (being not drawn on scale) surrounds memory module 331, ON/OFF switch 310 and mode switch 367.Temperature sensor 330 (close to tip positioning) monitoring tissue temperature.Separation electrode 380 (Fig. 8 A) allows to divide or point separation It is transported to the energy of electrode pair 301/302 and 311/303.Dual amplifier or time division multiplexing/switching main amplifier 416 are located at energy Amount is directed between the electrode pair of target 101, is avoided 111, is produced asymmetric ablated volume.Minor diameter is injected from single entrance Electrode needle, minimize scar, and simplify accurate electrode and place.
Connector is made up of the dielectric sleeve 309 being tapered for covering carinate stainless steel electrode pipe 302.Insulating sleeve 309 are made up of suitable bio-inert material, and it covers electrode 302.Dielectric 305 makes cone point electrode 351 and 301 exhausted Edge.
Figure 11 A ablative surgeries (not utilizing assist probes).
The region (frame 531) that ablation probe 371 by anatomy inserts and be directed to where the target wherein to be melted nerve. Apply test electric current 811 (frame 532).If probe is positioned to against target nerve, will detect/it was observed that physiological reaction (such as: During place between the eyebrows wrinkle is eliminated, it will it was observed that the muscular irritation of forehead).If it is observed that reaction, then can be alternatively in skin Apply mark on surface to position the region of nerve.Apply electric power (frame 535) to attempt to melt nerve.If life is not observed Reason reaction, (frame 534) probe will be relocated to be neural closer to target, and repetitive stimulation is tested (frame 536 and 537). If physiological reaction is not observed, operation (frame 544) can be terminated.In addition, probe can in any direction (it is upper and lower, Closely, far, circle, pattern etc.) on move, to produce bigger ablation area, for more longlasting result.
In frame 537, if observe stimulates again, ablation power can be set get Geng Gao (frame 538), Huo Zheru Upper described, pin can move in all directions, or can apply the energy of larger dose again, to form bigger ablation Area is used to more effectively or for good and all terminate the signal transduction by nerve.After transmitting electric power (frame 540), it can apply again Stimulation energy (frame 541).If do not stimulated, (frame 544) is completed in operation.If still have signal flow through nerve (stimulate or Physiological reaction), then probe may be relocated (frame 542), and performed the operation and started again at (frame 533).
Figure 11 B use the flow chart of the vision guide ablative surgery of assist probes (such as 771 and 772).
Assist probes 771 and 772 (Figure 13 A and 13B) provide a kind of quickly and accurately positioning target structure 101 simultaneously then The method for marking target position 755.Assist probes may be more much smaller than ablation probe (such as acupuncture needle).Structure generally uses ink or class Marked like pen (pen), it is allowed to which the ablation probe 371 or other ablation probes of illumination are rapidly directed into mark 755.It is optional Ground, non-illumination probe can be used, it is allowed to which operational staff only experiences probe tip.For deep structure, probe 771 (Fig. 8) quilt As electronic beacon.It is used to guide ablation probe similar to stimulating current but smaller low current 811 from probe tip 702 372 (Fig. 8).
Operate 530 (Figure 11 B) insertion assist probes 771 or 772 (Figure 13 A and 13B) and pass through the skin close to neuropeptide 11 01 330 and muscle layer 710.The depth 766 (Figure 13 A and 13B) of target 101 is measured using assist probes mark 765.If in 534 Adjustment is not performed, then determines whether 533 inspection probes are in place.Neurn simulation electric current 811 is realized in operation 532.Pierced when obtaining muscle When swashing or obtaining physiological reaction, assist probes tip is in place.By reading mark 765 it may be noted that depth, and can be Position mark 755 is carried out in operation 535.Operating 536 and 537 middle probes in place, setting power electricity of operation 538 below mark Put down 404 and close ablation switch 410.Alternatively, stimulation directly can apply from ablation probe, as instructed elsewhere 's.Operation 540 and controller 401 set the frequency of generator 411 (Fig. 7), modulate 420 envelopes and enable power amplifier 416 Enough convey default ablation energy.Region 1203 (Figure 10) shows the overall shape of such as ablation areas of cone point 301.
Between each ablation, 540 (Figure 11 A) (nerve conductions) of test operation in 541.Probe amplifier 416 is from electricity Pole 301 or assist probes 771 or both convey small nerve stimulating current 811.Based on nerve conduction test 541, if realized Required conduction level, then operation is competition.Probe is moved to next position and repeats conduction test 541 by operation 542. If competition, probe is removed in operation 544.Quantity and ablation intensity/energy are according to particular procedure and desired persistence Set.Operational staff selects operation/power level 404 (Fig. 7), and controller 401 compares installation via 331 (Fig. 7) of identification Probe, for meeting selected operation., will be to if the probe of installation does not meet selected power bracket 404 Operational staff alarms.
As example rather than limitation, five ablation areas (140,141,142,143 and 144) are shown in Figure 10.Disappear Melt since region 144, probe is then moved to 143 etc. until 140.Alternatively, movement can be during insertion with horizontal stroke It is in a circular manner or other means mobile to expand the region of target nerve damage to mode.Every time nerve can be tested after ablation Reaction, so as to allow operational staff to check the level of nerve conduction immediately.If desired, carried out before extra ablation is applied Probe location and power adjustment.Accurate probe positioning instrument and the method instructed herein allow using minimum ablation energy, So as to minimize the injury to non-target structure.This, which is converted to, reduces healing time and minimum patient discomfort.The present invention, which gives, to be held The new instrument of administrative staff is performed the operation to perform minimally invasive nerve conduction limitation, is had temporarily or permanently refreshing with new confidence level selection Ability through conduction blockage.This new tool provides the operation of low cost, generally carries out in office or clinic, generally makes Carried out with local anaesthesia less than one hour.Compared with prior art, its surgery needs suture and longer healing interval, And the Control constraints of persistence (nerve regneration length).
Assist probes 771 and 772 (Figure 13 A and 13B) are accurately positioned target structure 101, then mark target position 140 to 144. Shallow structure is generally marked with pen (755), it is allowed to which illumination will be quickly guided to the ablation probe 371,372 or equivalent of the point Thing.For deep structure, instructed using probe 771 as electronic beacon, such as Figure 14, use the small electricity from probe tip 702 811 are flowed to guide ablation probe 372.
Ablation probe 372 is inserted by the skin 330 close to neuropeptide 11 01 and muscle layer 710.Light source 408 allows to perform Personnel rapidly and accurately guide 448 ablation probes 372 of illumination in place.The illumination 448 such as executor of ablation probe 775 findings of member, it is used as the additional aids of estimation of Depth.Optional neurn simulation electric current 811 aids in default in region 1204 Position neuropeptide 11 01.This novel probe place system makes operational staff's belief system normal work, therefore s/he can be absorbed in Careful operation.Accurate probe location allows to use minimum energy during ablation, minimizes the injury to non-target structure, And reduce healing time and patient's discomfort.
Region 1203 shows the overall shape of the ablation areas for cone point 301.Tip 301 be placed with close to Target neuropeptide 11 01.Ablation usually requires once or a series of local ablations.Quantity and ablation intensity/energy according to particular procedure and Desired persistence setting.
Five ablation areas 140,141,142,143 and 144 are shown in figure;However, it is possible to have more or less Region.Then probe is moved to 143 etc. until 140, on the contrary, ablation can start 140 by ablation since region 144 And proceed to 144.In addition, operational staff can perform rotary motion, so as to further increase the area of ablation and operation Persistence.Between each ablative surgery 540 (Fig. 5 C), send small nerve stimulation from electrode 301 and test electric current 811.Nerve The approximate effective range of stimulating current 811 is by 1204 displays.Testing nerves reaction after ablation every time allows operational staff to examine immediately Look into nerve conduction level.In the case where no probe 372 removes, operational staff will obtain on the anti-of ablation quality immediately Feedback.Then small probe location adjustment is carried out before extra ablation (if desired) is carried out.
Figure 10 shows another example of the system for being used together with method described herein with operation.First, visit Pin electrode 301 is placed on desired position (Figure 10) relative to target neuropeptide 11 01, then the power setting selected by user's use 404 (Figure 10) start via switch 410 and 310 to be treated.Generator 411 (Figure 10) and 412 are configured to amplitude-frequency by controller With modulation envelope, conveying 50KHz-2.5MHz 5 to 500 watts of utilisable energy.Summing point 413 needs combination RF defeated according to application Go out, and transfer them to pulse width modulator 415 and carry out output power.The output of modulation generator 420 is believed with radio frequency Numbers 422 and 423 put on multiplier 415.This allows complicated Energy distribution to be transported to time-variant nonlinear biological load.It is all These settings are all based on installed probe 371 and are supplied to the information of generator, selected power 404 to set and then The modulation envelope 420 (Figure 10) loaded by generator 421 is set.
For example, the high-amplitude sine wave 910 (Figure 15) for cutting and pulsewidth modulation (or PWM) sine wave for solidification 920 be all well-known in electrosurgery field.The limitation of accurate power and average total power is controlled by integrator 435, The injury to neighbouring structure is minimized, or the burning close to skin under shallower operation.As neighbouring structure 111 (Fig. 8 B) When being too near to and can not be avoided by such as 371 (Fig. 9 A) and 372 (Fig. 9 B) electrode, extra probe as taught herein is several What shape provides other method and carrys out guide energy and limit ablation to arrive less region, so as to avoid other structures.In order to For the sake of safety, in the case where the system failure occurs, hardwire switch 436 disables power amplifier, and probe is pulled out or is in Over-power condition, so as to protect patient and operational staff.
The output of modulator 415 is applied to the input of the part of power amplifier 416.416 outputs of power amplifier It is then fed into impedance matching network 418, it provides dynamic control output to alterable height and nonlinear biological load, And need dynamic control power level and impedance matching.The tuning of matching network 418 is performed for the power of optimization probe The stabilization of transmission, power level and therapeutic frequency.Peak power for the system of embodiment of the disclosure is 500 watts.Pass through The control loop that sophisticated neighbouring and generator includes in itself, which is established, to be accurately controlled.Last energy envelope 420 is transported to spy Needle tip 301 and refurn electrode 302.
The ablation of guiding
In addition to the substantially radial symmetrical ablation mode for the probe instructed in such as 371 (Fig. 9 A) and 372, switching Or division ablation power can generate asymmetric ablation areas to multiple electrodes (Fig. 9 D).With probe 610 (Figure 12 A and 1B) The skin 330 that minimizes in the injury or shallow-layer operation of neighbouring structure 111 of high-intensity source 608 burn.In addition, Fig. 8 B and figure 9D identifies the probe configuration for selectivity or asymmetric ablation.
Feedback of Power
The feedback signal 437 of power amplifier output 430 and buffering may be coupled to analog-digital converter (or ADC) 431, use Analyze and control in processor.The signal 437 controls algorithm for power modulation 420 to set and influence impedance matching control signal 419.Should Integrated power signal 437 is recorded to operating condition database (Figure 16 A) so that operation later examines.Such as with perform the operation maximum Compare, the power level is also compared with the reading read from probe 1492 (Figure 16 B), if it does, next can then prohibit Only amplifier exports, so as to protect patient from mistake or equipment fault.Similarly, it can alternatively use and come from probe and hair Raw device sensor (such as temperature 330) is limited to terminate or substantially reduce the power level of modulation and final operation.
Controller as described herein can also verify 1415 (Figure 16 A) of selected operation and the probe of installation compatibility.Such as Fruit is incompatible, then also prompts user to select different power settings 404, operation or probe 371.If the mesh power of probe 371 404 are set, then system enables power amplifier 416, guides light source 408 and low pressure neurn simulation 732.The two operations are all logical Cross what enforceable " handshaking " scheme and serialization information performed, it must be by being on the electronic circuit of the operation to be formulated Verified now and suitably.In clinical operation, information needs to be passed on by the embedded electronic instrument in probe, This provides the another way for implementing the protection, so as to be again prevented from reusing for unauthorized.Final goal is to prevent from suffering from Cross pollution between person.Probe will be realized by uniqueness, serializing and given above-mentioned operation.Once insertion, visit Sequence number will be input in digital data recording system by pin via universal serial bus 403, and then circuit logic will prevent from hereafter again making With probe and cross pollution occurs.In addition, the program will prevent to use unwarranted third party's probe, because they will not be by Activation, prevent potential poor quality or not authenticated probe use and there is potential danger to patient.
Optical probe instructs
Disclosed invention is provided by supplementing stimulus 732 and placing (Figure 17) as initial guide come assist probes Light source 408.Probe 771 can nerve stimulator or be to and from assist probes tip 702 electric current 811 measure between selected Select.The selection low energy stimulator of ablation probe switch 367/receiver or the high-energy for being to and from probe 371,372,373 and 374 Ablation.In this mode, doctor operator will obtain previously enterprising on the surface of skin by described various means Capable mark 755.When if 448 illumination opticals are connected, doctor operator 775 then will be seen that tip.It 448 will under the skin side Bright spot, the sophisticated position relative to mark 755 of instruction are provided.Then, doctor 775 will guide probe tip 301 to arrive in these marks 755 times accurate alignments of note, so as to melt the target tissue 101.Optional probe configuration
Figure 19 is the schematic diagram of the alternative embodiment of the single shaft electrosurgical probe 2000 with longitudinal probe axis 2001, its It is similar with above-mentioned probe.However, Figure 19 probe 2000 is characterized in that with the roughly equal surface positioned along the longitudinal axis Product conductive electrode 2002 and 2004.Being illustrated above also has the probe for the surface area electrode 301 and 302 being substantially identical 371。
In waiting electrode surface area to implement, as described above, one in conductive electrode 2002,2004 optionally connects To stimulating current source or ablation current source.Other electrodes 2002,2004 can be not connected to or the ground connection of current source as connection Or return path is attached.In embodiment shown in Figure 19, conductive electrode 2002, which is configured to connect to, makes electrode 2002 be the ablation source of active electrode.Therefore, electrode 2004 is refurn electrode in the present embodiment.Any electrode 2002,2004 It may be coupled to current source or returned with appropriate switch.
Because electrode 2002 and 2004 has the surface area being substantially identical, therefore disappear applying RF to active electrode 2002 Melt the heating zone for the ellipsoid form that the local heating formed during energy causes to have substantial symmetry.
Figure 19 single shaft electrosurgical probe 2000 is further characterized in that dielectric insulator 2006 is placed with along in conductive electricity Probe shaft between pole 2002 and 2004.Dielectric insulator 2006 can have any suitable length, and have optional length The probe of the insulator of degree can be produced for specific ablative surgery.The length for changing dielectric insulator 2006 changes electricity Gap size 2008 between pole 2002 and 2004.Change the optimization that gap size 2008 provides current density in zone of ablation, If desired, change the length of zone of ablation and allow to use higher voltage.Therefore, such as electrode surface area can be combined and disappeared Melt the other parameters of electric current to select gap size, to realize for application-specific selection ablated volume and tissue temperature.
Figure 19 probe 2000 also has blunt tip 2010, rather than cone point 351, chisel edge end 352 or this paper institutes The other tips for the probe stated.Figure 19 blunt tip 2010 has smooth circular contour, and has in some cases Profit, to allow probe to be easily advanced and manipulate under the skin, so as to minimize puncture or adjacent tissue or anatomical structure The risk of cutting.Therefore, blunt tip 2010 can reduce the bruise or other wounds associated with operation with significant.
Figure 19 probe 2000 can include sensor 2012.Sensor can be temperature sensor 2012.TEMP Device provides the active temperature monitoring in zone of ablation.Alternatively, the single shaft electrosurgical probe of any configuration can use Kalman filter Device is realized, as such as being instructed by Conolly U.S. Patent No. 6,384,384, entire contents are by quoting simultaneously Enter herein.Kalman filter is also used for estimating the tissue temperature in ablated volume.Kalman filter is applied in specific temperature Under degree due to protein denaturation (such as collagenous degeneration at 65 DEG C) and occur clearly limit structural state change situation. Kalman filter temperature monitoring is favourable, because the volume and cost of single temperature sensor can be avoided.
Figure 20 is the schematic diagram for the asymmetric single shaft probe 2014 for also limiting longitudinal probe axis 2015.The feature of probe 2014 It is the first conductive electrode 2016 and the second conductive electrode 2018 with different surfaces product.Shown embodiment in fig. 20 In, first electrode 2016 is active electrode, and the second electrode 2018 with large surface area is refurn electrode.In active electrode The probe with any surface area ratio can be manufactured between refurn electrode, and for realizing specific ablation result.In addition, can To switch the sophisticated relative position of active electrode 2016 and refurn electrode 2018 relative to given probe.In one embodiment In, the surface area ratio of active electrode 2016 and refurn electrode 2018 is 1:3.Other ratios, including 1 can be implemented:8, with up to To specific result.Sleeve or other mechanisms can be used further to adjust surface area ratio, the sleeve or other mechanisms will shield Or the part on covering electrode or two electrodes, so as to increased or decrease the length in the gap for limiting dielectric insulator 2019.It is logical Often, due to the higher current density of the RF ablation energies at the electrode with small surface area, asymmetric electrode surface Product will cause asymmetric heating and ablation.For example, in the active electrode being applied to RF energy in Figure 20 embodiment, by The larger current density caused by the relatively small surface area as active electrode 2016, close to the organizer of active electrode 2016 Product may be heated asymmetrically.The asymmetric tissue of thermal coupling and various probes are integrated with the accurate RF power instructed herein Geometry allows to form selected repeatable and controlled ablated volume.
Figure 21 schematically shows optional asymmetric probe 2020, its asymmetric probe with Figure 20 in many aspects 2014 is similar.However, Figure 21 asymmetric probe 2020, which is characterised by that active electrode 2022 has, is more than refurn electrode 2024 Surface area surface area.In Figure 21 embodiment, current density is higher at relatively small surface area electrode 2024, because This ablation energy is concentrated in the dielectric insulation body space 2025 between electrode 2022 and 2024, closer to refurn electrode 2024 And the tip away from probe.
Figure 22 is the schematic diagram of one embodiment of multi-electrode probe 2026.Multi-electrode probe 2026 includes limiting longitudinal direction spy The probe body 2028 of the substantially aciculiform of needle axis 2029.More than two electrode is associated with probe body and is placed on edge At the diverse location of probe axis.In Figure 22 embodiment, electrode includes active electrode 2030, refurn electrode 2032 and stimulated Electrode 2034.In this embodiment, active electrode is placed near the tip of multi-electrode probe 2026, the quilt of refurn electrode 2032 Tip is placed away from, and stimulating electrode 2034 is placed between active electrode 2030 and refurn electrode 2032.Should Pay attention to, thus it is possible to vary various electrodes place advantage to realize specifically to melt with the position at tip with probe relative to each other.This Outside, the connection as any given physical electrode of active electrode, return or stimulating electrode can be utilized in electrode by user Simple switching mechanism between ablation or stimulation energy source freely changes.Individually it is grounded or returns it is alternatively possible to utilizes Loop footpath 2035 and any configuration of electrode.Each electrode of multi-electrode probe 2026 is by the first dielectric insulator 2036 and second Dielectric insulator 2038 separates.Figure 23 schematically shows Figure 22 multipole probe 2026, with the addition of associated with electrode The relative bent portion 2040 in the part of probe body 2028.In some cases, bent portion 2040 can allow operational staff Realize that optimal probe is placed with the unnecessary disorganization of minimum.Multi-electrode probe 2026 can use various sizes of dielectric Insulator 2036,2038, the sensor of different surfaces product or electrode are realized, as above described in whole, to realize desired ablation As a result.
Figure 23-25 schematically shows the alternative embodiment of multi-electrode probe 2042.Multi-electrode probe in Figure 23-25 2042 include limiting the probe body 2044 of longitudinal probe axis 2045.Multiple electrodes 2046-2062 along probe axis not It is associated with probe body 2044 with opening position.In embodiment shown in Figure 23-25, the size of electrode and interval are uniform. However it is important to note that, it is possible to achieve the uneven interval of various sizes of electrode and electrode is to realize specific ablation As a result.Preferably, each in electrode 2046-2062 can be connected to stimulation optionally by one or more switches Current source, ablation current source, the ground connection for stimulating current source, the ground connection for ablation energy source keep not connected.It is as follows As face is described in detail, by by the switching of each electrode be connected to current source or the flexibility that provides of ground connection in probe location and Some advantages are provided in terms of ablation.In addition, multi-electrode probe 2042 can be disposed with reference to single refurn electrode 2064, It is typically placed in and is contacted away from ablation site with tissue.
Allocation method
It discussed above is and probe is suitably disposed adjacent to several method of the selected nerve for ablation energy application. For example, it is discussed in detail probe allocation method, it is characterised in that fluorescent marker dyes, the light using low energy nerve stimulating current Learn probe guiding and electron probe guiding.Some optional probe configurations shown in Figure 19-25 are provided using above-mentioned basic The fine probing needles allocation method of the modification of electrical stimulation technology.
Figure 18 single shaft electrosurgical probe 2000 or asymmetric probe described herein 2014,2020 can be each using repeatedly Generation technique is suitably placed, as explained above with described in Figure 11 A-C.Iteration allocation method can be refined for it is more electric Pole probe is used together, described in such as Figure 16-20.
In the probe embodiments that stimulating electrode is placed between ablating electrode 2030,2032, above-mentioned alternative manner is protected Card target nerve is placed in oval zone of ablation 2064 (see Figure 17), and the oval zone of ablation 2064 (see Figure 17) will apply Formed during RF ablation energies between active electrode 2030 and refurn electrode.
Figure 23-25 shows the optional reality in the multi-electrode probe 2042 disposed relative to target nerve 2066 with various orientations Apply example.For example, in fig 23, multi-electrode probe 2042 is positioned to across nerve 2066, in fig. 24 multi-electrode probe 2042 The part parallel to nerve 2066 is positioned to, and Figure 25 shows and multi-electrode probe 2042 is placed in into target at a certain angle On nerve 2066.It is described above, it each can preferably selectively be connected to stimulating current in electrode 2046-2065 Source, ablation energy source, ground keep not connected.Electrode 2046-2062 can manually be connected or electronically be switched and swash It is living.
The multiple electrodes of embodiment in Figure 23-25 of multi-electrode probe 2042 provide some advanced placements and ablation Operation.For example, Figure 23 is shown for positioning target nerve 2066 and optionally applying the method for energy to target nerve 2066, should Target nerve 2066 is substantially transverse to probe trend at the point of the axial length along probe 2042.The allocation method is characterized in Probe is initially placed on target nerve 2066 by operational staff.Then, electrode 2046 to 2062 is in adjacent active/ground connection pair It is activated using stimulating current or is individually activated dependent on external ground 2064 (monopolar mode) successively in (double pole mode).So Afterwards, when stimulating current is applied to continuous electrode 2046-2062, operational staff can observe one associated with target nerve The reaction of individual or more muscle.
For example, with reference to figure 23, stimulating current can be applied between electrode 2046 and 2048.Operational staff pays attention to not having Corresponding muscle response.Next stimulating current can apply between electrode 2048 and 2050.Furthermore operational staff does not see Observe muscle response.Then, then stimulating current is applied in continuous electrode pair.When stimulating current is applied to electrode 2054 And when between 2056, it is understood that there may be slight muscle response.Apply stimulating current between electrode 2056 and 2058 however, working as When, it will be observed that strong muscle response.Continue, then applying between electrode 2058 and 2060 stimulates.Here observe To the muscle response greatly reduced, show nerve essentially through the probe between electrode 2056 and 2058.Then, Ke Yi Apply ablation energy between the electrode 2056 and 2058 specified to melt nerve 2066.
Figure 24 shows similar nerve location and ablative surgery, wherein nerve 2066 is arranged essentially parallel to probe 2042 Axial length is simultaneously adjacent thereto, neighbouring electrode 2048 to 2056.In second example, operational staff is first in the He of electrode 2046 Apply stimulating current between 2048.Slight muscle response can be observed or without muscle response.When electrode 2048 and 2050 it Between apply stimulating current when, operational staff notices strong muscle response.
Then, between stimulating current being applied into electrode 2050 and 2052, it was observed that similar strong muscle response.Pass through Active electrode 2056 and 2058 substantially weakens to observe this continuous stimulation and course of reaction, wherein muscle response or can not Observation.This shows that electrode 2048 to 2056 all contacts with nerve 2042.Electrode 2048 to 2056, which may then switch to, to be activated Ablation current source, and with bipolar to being sequentially or simultaneously switched or individually being switched over bipolar or monopolar mode, With ablation nerve 2042.The selection length that nerve can be limited along the number of electrodes activated by operational staff is melted. This method can also be realized with monopolar mode, thus apply in one or more electrodes 2046 to 2062 and outside body Apply stimulation or ablation energy between single refurn electrode.
Figure 25 shows substantially similar nerve location and ablative surgery, wherein multi-electrode probe 2042 and probe axis pair Angle or with angle of inclination intersect nerve 2066.Therefore, Figure 25 shows probe 2042 relative to the angled of nerve 2066 The method of placement.In this example, the stimulating current applied as described above at electrode 2052,2054 and possible 2056 will be led Cause the reaction of associated muscle.If large number of electrode causes muscle response, this is relative to god by probe 2042 Instruction through broader nerve/probe contact area caused by 2066 more parallel contact placement.Can by relative to There is the probe of relatively short distance to strengthen this angled peace between neural diameter manufacture adjacent electrode of concern The determination put.Operational staff can also manipulate probe to obtain muscle response from more or less electrodes as needed, there is provided Longer or more short length neural chance is melted in the case where not repositioning probe axially.
The method that above-mentioned angled probe is placed and order stimulates can combine with same above-mentioned iterative technique.Example Such as, stimulating current generator at relatively high level and can ought determine nerve relative to some electrodes substantially with initial setting up Reduce during position.
For example, stimulating current threshold value (to draw observable reaction) between Figure 25 electrode 2048 and 2050 is by height Threshold value between electrode 2050 and 2053.The information can be indicated with figure, numeral or the sense of hearing, to allow operational staff's weight New definition probe, with relative to nerve 2066 it is more parallel or more laterally place probe 2042.
The above apparatus and method can be by the various features of the security of strengthening system, ease for use and validity come real It is existing.For example, probe can be realized with the handle for meeting ergonomics and functionalization, which increase operation validity and provide The realization of security feature.Single probe can be managed with delicacy, it is preferred to use system software ensures normal work Selected probe is sterile and is not repeated use, and appropriate probe is used for each specific treatment operation.It is similar Ground, system can include safeguard, to ensure that operator is authenticated and trained to selected particular treatment.Can be with Various Case management methods and particular treatment therapy are selected for optimum and for strengthening patient safety.In a reality Apply in example, treatment, therapy and security method menu can be by running on the processor associated with ablating device and system Software is implemented and strictly controlled, as described in detail later.
Method for managing system
The concurrent mesh of patient safety, procedure efficiency and success rate can be improved by efficient system management method Mark.Such as system as described herein management method can be realized by computer software and hardware, the computer software It is included in hardware in console and probe system described herein or the computer processor and memory of matched operation. It there may be the various interfaces between operational staff, console and probe system.In addition, with including probe stimulating current source, disappear Melting the associated hardware of ablation system of current source and probe system can communicate with system processor and be carried to system processor For feedback.Alternatively, the step of method for managing system can be with manually implemented.
It is described below to be used to manage electrosurgical probe and system in the system embodiment based on software and processor Technology may be implemented as producing software, firmware, hardware or the side of any combination using standard program and/or engineering technology Method, device or product.Term " product " used herein refer to medium or equipment (for example, such as hard disk drive, floppy disk, The magnetic storage mediums such as tape), optical memory (such as CD-ROM, CD etc.), volatibility and non-volatile memory devices (example Such as, EEPROM, ROM, PROM, RAM, DRAM, SRAM, firmware, FPGA etc.) on realize or storage code or patrol Volume.Code in computer-readable medium is accessed by a processor and performed.The code for wherein completing to realize can also pass through transmission Medium or by network from file server access.In this case, wherein such as net can be included by realizing the product of code Network transmission line, wireless transmission medium, the transmission medium by the signal of spatial, radio wave, infrared ray, optical signal etc.. Certainly, it would be recognized by those skilled in the art that in the case where not departing from practical range, many can be carried out to the configuration and repaiied Change, and product can include any information bearing medium known in the art.
Therapeutic treatment scheme
As disclosed herein, ablation of tissue or nerve block or other can be performed using the RF energy accurately applied Minimally invasive electrosurgery.The basic demand of therapeutic RF waveforms is in selected time range, is, for example, less than 25 seconds, in cell Tissue is heated in domain and makes human body tissue degeneratiaon.Laboratory experiment shows that this is melted enough needed for small kinesitherapy nerve Right times.Longer or shorter treatment time may be needed for other application.Make the fine structure of selected tissue (mainly Protein and lipid) denaturation needed for temperature be about 65 degrees Celsius and more than.
In order to safely realize appropriate ablation, nerve block or other treatment target, it can generate and apply RF waveforms To meet following standard:1. probe temperature, which will be limited in, is less than 160 degrees Celsius to prevent to the excessive of side shoot tissue regions Damage.2. probe temperature is preferably remained between 90 degrees Celsius and 105 degrees Celsius.The scope will prevent excessive tissue adhesion with And contribute to the growth of appropriate ablation lesions.
Initial RF power, which applies, should make the temperature of probe tip reach the treatment temperature of work in a controlled manner, produce most Small overshoot.The time range of initial heat-up stage can be between 0.2 to 2.5 seconds.
In order to realize above-mentioned broad object, specific therapeutic scheme can be developed.In one embodiment of the invention In, the conveying of particular treatment (being also been described as " energy group " (energy bolus)) herein is automation.Automatically Change can improve security and therapeutic effect, because when ensuring the conveying of selected energy group in system, operational staff can be with Concentrate on probe placement.For example, system controller 401 can be configured as the electrosurgical probe that control is fed to the system of being connected to Energy waveform.Especially, waveform, waveform modulated or burst length can be controlled.Furthermore, it is possible to apply the total time of power supply With peak power or voltage can be set to limit.In addition, particular treatment can be according to such as probe temperature, adjacent tissue temperature Degree, tissue impedance or the feedback of other physical parameters that can be measured during treatment energy conveys and be actively controlled.Can be with Specific energy transportation program or energy group are developed for specific therapeutic purpose.These energy schedulings can be controlled as what is allowed Treatment scheme is stored in the memory associated with controller.Representational treatment energy scheme 3250 is in fig. 26 with form shape Formula is shown.
Figure 27 therapeutic scheme 3250 is optimized for the therapeutic ablation for the human nerve that there is diameter to be about 1 millimeter. As shown in figure 27, therapeutic scheme 3250 is usually designed to the quick heating tissue during the starting stage 3252.Have been shown in just Quick heating during stage beginning can minimize the pain felt, and reduce with after-applied pulsed RF energy to muscle Stimulate.Second stage 3254 includes constant power and applied, and causes slower slope to reach desired therapeutic tissue/probe Temperature.Also as shown in figure 27, the phase III 3256 includes maintaining steady temperature to rise to ablation lesions with the power of reduction Desired size.
Therapeutic treatment scheme 3250 shown in Figure 26 and Figure 27 is that one kind is had been observed that suitable for small motorial The therapeutic scheme of ablation.Other therapeutic schemes for other or identical treatment target can be developed.In all cases, organize The level of ablation is generally exponentially related to time and more than 40 degrees Celsius of temperature product, as known in the art A Lieniwusi rates (Arrehenius rate).The heat transfer by target tissue can be calculated by finite-difference algorithm.Can With the specified tissue attribute on 2D grids, and these attributes can be the arbitrary function of room and time.For by elevated Degree of ablation caused by temperature, can solve A Lieniwusi rate equations.Furthermore, it is possible to measured and really by Histological research It is set for the electrical and optical properties of the characteristic for ablation tissue.Therefore, various therapeutic schemes (as shown in Figure 26 and Figure 27) can be with It is developed and optimizes controlledly to realize desired treatment results.Preferably, therapeutic scheme is automatically conveyed to ensure The energy group of selection is accurately conveyed.
Device, described below and system are provided as the construction of component and the example of details of arrangement.Present invention bag Include the various equipment, system and method that can be other embodiment and can be practiced or carried out in a variety of ways.In addition, this Wording and term used in text are in order at the purpose of description, are not construed as restrictive.Used herein " including (including) ", " including (comprising) ", " having (having) ", " including (containing) ", " are related to (involving) " and its variant is intended to the item and its equivalent and other item listed thereafter.

Claims (84)

1. a kind of be used to treat the neural system in tissue regions, including equipment and controller, the controller are coupled to institute Equipment is stated, the equipment has working end, wherein the controller includes stimulus modality and energy transport model, the stimulation mould Formula comprises at least the first parameter setting and the second parameter setting, first parameter setting apart from the working end first away from The nerve is stimulated from place, second parameter setting stimulates the nerve at the second distance apart from the working end, its Described in the first distance be more than the second distance, and wherein described equipment is configured as preventing when the stimulus modality is in The energy transport model is activated during first parameter setting;
Wherein, when the working end of the equipment is positioned in the tissue regions and is swashed under the stimulus modality When living, the controller provides energy to allow to the neural stimulation under first parameter setting;
And when the working end of the equipment is repositioned in the tissue regions so that the working end to be moved to When under the stimulus modality being reactivated closer to the nerve and with second parameter, the controller conveys energy Measure to allow to the neural stimulation and confirm that the working end of the equipment is repositioned to closer to the nerve; And
When the equipment is activated in the energy transport model, the controller provides energy to be controlled predetermined Treat set it is lower produce on the first neural treatment region, wherein, in the energy transport model activating the equipment makes Obtain the controller and reset to first parameter setting.
2. system according to claim 1, at least one dispensing end being additionally included at the working end of the equipment Mouthful.
3. system according to claim 1, in addition to external neurostimulators, its be configured as insert the equipment it It is preceding that nerve anatomies are mapped on skin, for use as the guiding of identification target treatment position.
4. system according to claim 1, wherein, first parameter setting is set including the first electric current, and described Second parameter setting is set including the second electric current, wherein, second electric current, which is set, is less than first electric current setting.
5. system according to claim 1, wherein, first parameter setting is fixed.
6. system according to claim 5, wherein, second parameter setting is adjustable.
7. system according to claim 1, in addition to measuring electrode, wherein, with described under first parameter setting Stimulus modality activates the equipment to observe to the neural stimulation including the use of measuring electrode measurement and the nerve Electric pulse in associated at least one muscle.
8. system according to claim 1, wherein, the predetermined treatment, which is set, includes predetermined temperature.
9. system according to claim 1, wherein, the equipment or controller include manual override, with described Stimulus modality allows to apply the energy transport model when being in first parameter setting.
10. a kind of neural system for being used to treat the muscle associated with nerve, the system include:
It is coupled to single longitudinal probe of controller, wherein, single longitudinal probe is configured for insertion into tissue regions In;
Threshold value stimulating current on the controller is set, wherein, the probe, which is prevented from applying, is equal to or higher than the threshold value The treatment energy that stimulating current is set;
The controller also includes stimulating current and set, and it allows energy by the conveying of the probe to trigger and the nerve The motion of the associated muscle;
Wherein, the controller is additionally configured to set the stimulating current and is decreased below the threshold value stimulating current and sets Put so that the stimulation area of the probe reduces;
Wherein, when the stimulating current, which is set lower than the threshold value stimulating current, to be set, the god is stimulated by the probe Through, it is thus identified that in the stimulation area of reduction of the neural position in the probe;
Treatment on the controller is set, and it is configured as the threshold value that the stimulating current is set lower than on the controller Electric current is applied in when setting so that and the treatment, which is set, allows the probe to apply electric current to heat the nerve, wherein, in institute After probe is stated with the treatment setting application electric current, the controller, which is configured as setting the stimulating current, resets to height In the threshold value stimulating current.
11. system according to claim 10, in addition to injection port on the working end of the probe and it is coupled to The infusion source of the processing end of the probe.
12. system according to claim 10, in addition to external neurostimulators, it is configured as inserting by the probe Before entering the tissue regions, the nerve anatomies in the tissue regions are mapped.
13. system according to claim 10, wherein, it is fixed that the threshold value stimulating current, which is set,.
14. a kind of be used to treat the neural system in tissue regions, the system includes:
Probe, the probe have the working end for being used for being positioned in tissue;
Controller, the controller are configured as providing electric power to the probe with Therapeutic mode and stimulus modality;
Wherein, the controller is additionally configured to can adjust between multiple stimulations are set, the multiple to stimulate setting at least to wrap Including the first stimulation setting and second stimulates setting, and wherein described controller is additionally configured to prevent in the Therapeutic mode Apply electric power and set unless being arranged to described second and stimulating;
Wherein, compared with the effective stimulus area of the probe under setting is stimulated described first, stimulate and set described second Put down the effective stimulus area for reducing the probe so that the working end of the probe is in described second stimulates and set Than must be closer to the nerve in stimulating and set described first to stimulate the nerve;And
Wherein, the controller be additionally configured in the Therapeutic mode apply electric power after be reset to it is described first stimulate set Put.
15. system according to claim 14, in addition to the opening fluid coupling on the working end of the probe Anesthetic supply.
16. system according to claim 14, wherein, it is fixed that first stimulation, which is set,.
17. system according to claim 16, wherein, the second stimulation setting is adjustable.
18. system according to claim 14, wherein, the probe is included in the energy transmission portion on the working end Point, wherein, the energy transmission part comprises at least longitudinally spaced the first current-carrying part opened and second on the probe and led Electric part, first current-carrying part and second current-carrying part are separated by electrically insulating material.
19. system according to claim 14, in addition to be located on the working end and be located at first current-carrying part Fluid port between second current-carrying part.
20. system according to claim 14, wherein, the surface area of first current-carrying part and second conductive part The surface area divided is different.
21. system according to claim 14, in addition to be spaced apart with first current-carrying part or the second current-carrying part At least one other current-carrying part.
22. system according to claim 14, in addition to it is located at first current-carrying part and second current-carrying part Between temperature sensor.
23. system according to claim 14, wherein, the insulating materials includes the profile being tapered.
24. system according to claim 14, in addition to the light source on the working end.
25. system according to claim 24, wherein, the light source includes proportional to the amount of the stimulation energy Modulate flash rate.
26. system according to claim 14, in addition to the chamber that operationally sets of length along single shaft probe.
27. system according to claim 26, wherein, the chamber connects with fluid reservoir.
28. system according to claim 14, wherein, the controller is additionally configured to determine around the probe The impedance of tissue.
29. system according to claim 14, wherein, the probe also includes handle, and the handle, which is configured with, to be used for The switch of the controller is adjusted between the Therapeutic mode and the stimulus modality.
30. system according to claim 29, wherein, the switch is oriented to the singlehanded use for allowing the switch.
31. system according to claim 14, in addition to the indicator source on the handle.
32. system according to claim 31, wherein, the indicator source provides to be regarded for the first of the stimulus modality Feel indicator and the second visual detector for the Therapeutic mode.
33. system according to claim 14, wherein, described first stimulates setting to include 0.07 milliampere.
34. a kind of electrosurgery unit, the electrosurgery unit is used to be used together with mould with treatment energy source with stimulation energy source Treatment hypodermis is fitted, and for being used together with the holder with flowable mass, the equipment includes
Equipment body;
Probe, the probe is from the part extension of the equipment body, and the probe is rigid so as to the equipment master The manipulation of body allows to move the probe in tissue;
Remote electrode, the remote electrode positioning is at the working end of the probe;
Proximal electrode, the proximal electrode are positioned on the probe and are spaced apart with the remote electrode in nearside, its In, the remote electrode and proximal electrode can be coupled to the stimulation energy source and the treatment energy source, wherein, treatment The application of energy to the remote electrode and proximal electrode is developed across the tissue between the proximal electrode and remote electrode Damage in region;
Fluid distribution sleeve, the fluid distribution sleeve have one or more fluid ports, the fluid distribution sleeve quilt It is positioned between the remote electrode and proximal electrode, wherein, at least one fluid port in the fluid port is directed The side of the axis vertical take-off of probe described in Cheng Yu is delivered up the flowable mass so that the flowable mass is directed into The tissue regions.
35. equipment according to claim 34, including fluid distribution chamber, by the flowable mass in the axial direction It is transported to from the tip of the probe in the tissue.
36. equipment according to claim 34, in addition to the opening being fluidly coupled on the working end of the probe Anesthetic supply.
37. equipment according to claim 34, wherein, the surface of the surface area of the remote electrode and the proximal electrode Product is different.
38. equipment according to claim 34, in addition at least one be spaced apart with the proximal electrode or remote electrode Individual other electrode.
39. equipment according to claim 34, in addition to the temperature between the remote electrode and the proximal electrode Spend sensing element.
40. equipment according to claim 34, in addition to the light source on the working end.
41. equipment according to claim 40, wherein, the light source include with the amount of stimulation energy conveyed into than The modulation flash rate of example.
42. equipment according to claim 34, wherein, the probe also includes the handle with least one switch, institute At least one switch is stated to be configured as switching the controller between the Therapeutic mode and the stimulus modality.
43. equipment according to claim 42, wherein, the switch is oriented to allow one hand to use the switch.
44. equipment according to claim 34, in addition to the indicator source on the handle.
45. equipment according to claim 44, wherein, the indicator source provides to be regarded for the first of the stimulus modality Feel indicator and the second visual detector for the Therapeutic mode.
46. equipment according to claim 34, wherein, described first stimulates setting to include 0.07 milliampere.
47. a kind of neural method treated in tissue regions, methods described include:
Equipment is navigated in the tissue regions at first position;
Used and be configured to apart from the first of the working end of the equipment at the first position by the equipment Set apart from described in internal stimulus neural first to the tissue regions and apply energy;
Observation is to the neural stimulation;
Used and be configured in the second distance apart from the working end of the equipment in the second place by the equipment Neural second sets to the tissue regions and applies energy again described in internal stimulus, wherein the second distance is less than described the One distance;
Reappraise and be stimulated under whether the nerve is set described second to determine the second place whether than described the One is located closer to the nerve;
If the second place is set to the neural stimulation closer to the nerve observing using described second When, apply treatment energy to the nerve using the equipment to influence the ability of the neural transmission nerve signal, with And set on predetermined treatment and monitor the nerve.
48. according to the method for claim 47, wherein, the equipment is reset to institute after energy is applied to the nerve The first setting is stated, methods described also includes the equipment readjusting second setting and then by the equipment Use and be configured as described in the second distance internal stimulus apart from the working end of the equipment in subsequent opening position The second of nerve is set to the tissue regions applies energy again.
49. according to the method for claim 47, wherein, by the equipment in the second place to the tissue area Domain applies energy and is included in again moves up the equipment to produce along described neural more relative to the neural side Individual treatment region.
50. according to the method for claim 49, wherein, include moving up the equipment relative to the neural side The equipment is being moved up forwards away from the first position along the nerve so as to the neural stimulation The period muscle associated with the nerve can be stimulated.
51. according to the method for claim 49, wherein, occurring in the case where not removing the equipment from site of puncture will The equipment is positioned at the first position and the second place.
52. according to the method for claim 47, be additionally included in before the second place applies energy again, not from In the case that the tissue regions remove the equipment, the equipment is moved in a plurality of directions.
53. according to the method for claim 47, it is additionally included in before applying energy to the tissue regions, described first Injecting narcotic at or near the tissue regions at position position.
Apply energy to reduction before the nerve in therapentic part 54. according to the method for claim 47, being additionally included in On the tissue regions surface temperature, and ice is held in place by during energy conveys.
55. according to the method for claim 47, it is additionally included in before the insertion probe, will using external neurostimulators Nerve anatomies are mapped on skin, and use guiding of the mapping as identification target treatment position.
56. according to the method for claim 47, wherein, described first sets and includes the first electric current and set, and described the Two settings include the setting of the second electric current, wherein, second electric current, which is set, is less than first electric current setting.
57. according to the method for claim 47, wherein, first setting is fixed.
58. according to the method for claim 28, wherein, second setting is adjustable.
59. according to the method for claim 47, wherein, observe includes observing the tissue regions to the neural stimulation Surface motion.
60. according to the method for claim 47, wherein, observe the neural stimulation is included it is pair related to the nerve At least one muscle of connection performs electromyography.
61. according to the method for claim 47, wherein, observe and the neural stimulation is measured including the use of measuring electrode Electric pulse at least one muscle associated with the nerve.
62. a kind of neural method treated in tissue regions, methods described include:
The working end of equipment is navigated in the tissue regions;
Stimulate the nerve;
The working end of the equipment is repositioned in the tissue regions, by the working end movement be closer to The nerve;
The equipment is reactivated under the stimulus modality with the second parameter, to observe to the neural stimulation, and confirmed To the working end of the equipment closer to the neural repositioning;And
Activate the equipment in the energy transport model, with the first neural treatment position produce on The first neural area for treatment;
By the working end of the equipment be repositioned at by it is described nerve control muscle and first treatment position it Between the neural distal portions on;
Activate the equipment in the energy transport model, with the second neural treatment position produce on The second neural treatment region.
63. method according to claim 62, wherein, the equipment includes stimulus modality and energy transport model, described Stimulus modality comprises at least the first parameter setting and the second parameter setting, and first parameter setting is apart from the working end The nerve is stimulated at first distance, second parameter setting stimulates the god at the second distance apart from the working end Through, wherein, first distance is more than the second distance, and wherein, the equipment is configured as in the stimulus modality The activation of the energy transport model is prevented during in first parameter setting.
64. method according to claim 63, wherein, the equipment is activated in the energy transport model makes described set It is standby to reset to first parameter setting.
65. method according to claim 62, wherein, position described in the working end and the repositioning of the equipment The working end of equipment occurs in the case where not removing the equipment from the site of puncture.
66. method according to claim 62, it is additionally included in before activating the equipment under the energy transport model, Injecting narcotic at or near first treatment region.
67. method according to claim 62, use external neurostimulators will before being additionally included in the insertion equipment Nerve anatomies are mapped on skin, and use guiding of the mapping as identification target treatment position.
68. method according to claim 62, wherein, the predetermined treatment, which is set, includes predetermined temperature Degree.
69. method according to claim 62, wherein, the equipment includes controller, and the controller is configured as Powered between the stimulus modality and the energy transport model to the equipment.
70. method according to claim 62, wherein, when the stimulus modality is in first parameter setting, The equipment can apply the energy transport model by manual override.
71. a kind of neural method treated in tissue regions, methods described include:
The working end of equipment is navigated in the tissue regions at first position, wherein the equipment is configured as applying Stimulation energy simultaneously is configured as applying treatment energy;
Wherein, when providing stimulation energy, the equipment is to may be configured as a setting in multiple settings, the multiple to set Put including at least first set and second set, wherein when the equipment described first set under operate when the equipment thorn It is larger to swash region, and wherein described equipment is configured as preventing from controlling described in application when the equipment is in the described first setting Treat energy;
The equipment is operated under being set described second;
On observing the neural stimulation reaction in the tissue regions;
When observing the reaction, apply treatment energy to described neural at least a portion at first position, to pass through The treatment energy is applied to the tissue regions to prevent the neural traffic nerve signal, wherein applying the treatment After energy, the equipment replacement to described first is set;
Set on predetermined treatment and monitor described neural at least a portion;
The working end of the equipment is repositioned at the subsequent opening position away from the first position;
The equipment is set from described first and is adjusted to second setting;
On the subsequent reaction to the neural stimulation observation in the tissue regions;And
When observing the subsequent reaction by applying treatment energy, the subsequent opening position to it is described it is neural extremely Few Part II applies treatment energy.
72. the method according to claim 71, wherein, the working end of the equipment is repositioned at subsequent position The place of putting is included in moves up the equipment relative to the neural side, to produce multiple area for treatment along the nerve.
73. the method according to claim 72, wherein, the institute of the equipment is being moved up relative to the neural side Working end is stated to be included in along the work that forwards moves up the equipment of the nerve away from the first position End so that the muscle associated with the nerve during the neural stimulation to being stimulated.
74. the method according to claim 71, wherein, not by the working end of the equipment from the tissue regions Occur the working end of the equipment being repositioned at the subsequent opening position in the case of removal.
75. the method according to claim 71, wherein, reposition the equipment the working end be additionally included in not from The tissue regions move the working equipment in a plurality of directions in the case of removing the working end of the equipment, without The working end of the equipment is removed from the tissue regions.
76. the method according to claim 71, it is additionally included in before applying energy to the tissue regions, described first Injecting narcotic at or near the tissue regions at position position.
77. the method according to claim 71, being additionally included in before applying treatment energy reduces on the processing region The tissue regions surface temperature, and ice is held in place by during the energy conveys.
78. the method according to claim 71, it is additionally included in and the tissue area is inserted into the working end of the equipment Use external neurostimulators to map the nerve anatomies in the tissue regions before domain, and known using the mapping Other target treatment position.
79. the method according to claim 71, wherein, first setting includes the setting of the first electric current, and described second Setting includes the setting of the second electric current, wherein second electric current, which is set, is less than first electric current setting.
80. the method according to claim 71, wherein, first setting is fixed.
81. the method according to claim 80, wherein, second setting is adjustable.
82. the method according to claim 71, wherein, on observing in the tissue regions the neural stimulation The motion for reacting the surface for including observing the tissue regions.
83. the method according to claim 71, wherein, on observing in the tissue regions the neural stimulation The reaction includes pair at least one muscle associated with the nerve and performs electromyography.
84. the method according to claim 71, described in observing in the tissue regions the neural stimulation React the electric pulse measured including the use of measuring electrode at least one muscle associated with the nerve.
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US14/602,187 US9113912B1 (en) 2015-01-21 2015-01-21 Systems and devices to identify and limit nerve conduction
US14/602,196 US9119628B1 (en) 2015-01-21 2015-01-21 Systems and devices to identify and limit nerve conduction
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