WO2016108331A1 - Passive bio-implanted pulsatile high-frequency stimulator for catheter for stimulating transsacral epidural spinal nerve - Google Patents

Passive bio-implanted pulsatile high-frequency stimulator for catheter for stimulating transsacral epidural spinal nerve Download PDF

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Publication number
WO2016108331A1
WO2016108331A1 PCT/KR2015/001112 KR2015001112W WO2016108331A1 WO 2016108331 A1 WO2016108331 A1 WO 2016108331A1 KR 2015001112 W KR2015001112 W KR 2015001112W WO 2016108331 A1 WO2016108331 A1 WO 2016108331A1
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high frequency
pulsatile high
pulsatile
frequency signal
treatment
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PCT/KR2015/001112
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French (fr)
Korean (ko)
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안상호
이상학
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영남대학교 산학협력단
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/06—Electrodes for high-frequency therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36071—Pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/36167—Timing, e.g. stimulation onset
    • A61N1/36175—Pulse width or duty cycle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36189—Control systems using modulation techniques
    • A61N1/36196—Frequency modulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Definitions

  • the present invention relates to a pulsatile radiofrequency stimulator for a catheter for passive biograft cervical epidural spinal nerve stimulation (hereinafter referred to as an pulsatile radiofrequency stimulator for passive catheter), in particular the generation of pulsatile radiofrequency by an appropriate algorithm according to the patient's symptoms.
  • the present invention relates to a passive extracorporeal pulsatile radiofrequency stimulator which transmits to a catheter implanted in the body so as to control pain or neuronal abnormality with the generated pulsatile radiofrequency energy.
  • Pulsatile radiofrequency has been used for the treatment of various chronic pain syndromes. Compared with persistent high frequency, there is almost no nerve damage, and it has recently emerged as a neuromodulator. It can also be seen as a tool to avoid steroid injections in elderly patients with chronic pain disorders, which can cause various complications due to repeated injections. Tricuspid neuralgia, failure syndrome after spinal surgery, complex site pain syndrome For the treatment of postherpetic neuralgia, peripheral nerve pulsatile radiofrequency therapy of spinal nerve, face and trunk and limbs is expanding. Recently, intraarticular pulsatile radiofrequency has been reported to reduce chronic joint pain. Intra-articular pulsatile radiofrequency is expected to act on intra-articular tissues rather than directly on nerve tissues to act as an anti-inflammatory and immune cell regulator.
  • Micropulmonary cells known to be important for the development of neuropathic pain in the dorsal horn, when pulsatile radiofrequency ablation is performed on the dorsal root ganglion of animals with neuropathic pain, It has been found that the activity of microglia), astrocytes, and substance P (substance P) are reduced. Peripheral nerves and joint pain, such as the central nervous system spinal cord and the pain perception of the brain becomes sensitive and central sensitization occurs, the central sensitization is involved in the activation of microglia. Central sensitization causes the pain in the local area to gradually expand, spreading the pain over a wide area, causing pain or spontaneous pain even with minor irritation and not responding well to any treatment.
  • pulsatile radiofrequency therapy that reduces the activity of microglia is required.
  • pulsatile radiofrequency treatment of the nerves over the entire length of the spinal cord is required because it does not respond well to single-time pulsatile radiotherapy for local nerves.
  • pain reduction or neuronal dysregulation effect does not last for a long time, so the pulsatile radiofrequency that can continuously control the pain or nerve abnormality of the patient by inserting a living implantable catheter A stimulation device is needed.
  • pulsatile stimulation of high frequency of 500,000Hz which is more effective than low frequency stimulation, is a biograft cervical epidural that can be stimulated throughout the spinal field to treat centralized sensitized chronic intractable pain or to control nerve abnormalities.
  • a pulsatile radiofrequency device for a catheter for spinal nerve stimulation is a biograft cervical epidural that can be stimulated throughout the spinal field to treat centralized sensitized chronic intractable pain or to control nerve abnormalities.
  • the present invention transmits the generated pulsatile high frequency and the generated pulsatile high frequency energy to the catheter implanted in the body so as to control the pain or nerve abnormality according to the patient's symptoms, thereby causing the patient's pain.
  • An object of the present invention is to provide an extracorporeal pulsatile radiofrequency stimulator for a passive catheter.
  • the extracorporeal pulsatile high frequency stimulation apparatus for passive catheter allows the pulsatile high frequency signal to be selected according to the patient's condition, and converts the selected pulsatile high frequency signal information into a therapeutic pulsatile high frequency signal in a wireless form.
  • Therapeutic pulsatile high frequency signal generator for converting and transmitting through the antenna;
  • Receiving a therapeutic pulsatile high frequency signal through the implanted antenna in the body may include a passive biograft catheter to generate an electrical stimulation to the site.
  • a therapeutic pulsatile high frequency signal generator provides a service for selecting a frequency required for treatment of pain or neuropathy control, and treatment based on frequency information selected by a physical force applied from the outside. And an input unit for generating and outputting a pulsatile high frequency signal generation request signal, and generating and outputting an initial signal for treatment when a therapeutic pulsatile high frequency signal generation request signal is input from the input unit, while causing the pulsatile high frequency signal generator to generate a pulsatile high frequency signal.
  • a control unit for controlling, a pulsating high frequency signal generating unit for generating and outputting a preset pulsating high frequency signal according to the control of the control unit, an initial signal for treatment from the control unit, and receiving pulsatile high frequency signal information from the pulsating high frequency signal generating unit Receive and mix to treat electrical scene Is a pulsatile high frequency gateway that converts the signal into a therapeutic signal and outputs a therapeutic electrical signal, a pulsatile high frequency power amplifier that receives and amplifies a therapeutic electrical signal from the pulsatile high frequency gateway, and converts the amplified electrical signal into a radio frequency therapeutic pulsatile high frequency. It may be made of a wireless power control unit for converting the signal to be transmitted through the antenna.
  • two therapeutic pulsatile high frequency signal generators are inserted for stimulation synchronization of two passive biograft catheters to insert two passive biograft catheters into the body to stimulate a desired spinal cord nerve segment. You can service in synchronization mode.
  • the input unit when the input unit selects a frequency required for pain treatment, it may serve to select a duration and treatment time of the frequency.
  • control unit provides a plurality of patient state information through an input unit, and if one of the patient state information is selected, the service for selecting a corresponding treatment frequency, duration, treatment time
  • the interface screen can be provided.
  • the treatment pulsatile high frequency signal generator further comprises a storage unit for storing the duration and treatment time information linked to the plurality of patient state information and the plurality of patient state information, the control unit, Information stored in the storage may be read and provided through the input unit.
  • the input unit may be provided in the form of a touch screen.
  • the wireless power control unit may perform high frequency matching with an antenna connected to an electrode, and may monitor an output state of a therapeutic pulsatile high frequency signal transmitted through the antenna.
  • an electrical stimulation may be generated at a corresponding site by receiving a pulsatile high frequency signal through an antenna of a passive biograft catheter implanted in the body.
  • the present invention transmits the generated pulsatile radiofrequency by the appropriate algorithm and the generated pulsatile high frequency energy according to the symptoms of the patient to the implanted catheter to control the pain or nerve abnormality, thereby allowing the patient to control the pain. It is effective in relieving pain and nerve abnormalities.
  • the present invention can generate and transmit a pulsatile high frequency signal required for treatment in vitro and non-invasive, thereby eliminating unnecessary pain generated every time a high frequency needle is inserted into the patient, and appropriately according to the symptoms of the patient. It is effective in controlling pain or nerve abnormalities.
  • FIG. 1 is a block diagram for explaining the configuration of the in vitro pulsatile high frequency stimulation apparatus for passive catheter according to the present invention.
  • 2 to 8 is a view for explaining the results of treatment through the extracorporeal pulsatile high frequency stimulation apparatus to which the present invention is applied.
  • 1 is a block diagram for explaining the configuration of the in vitro pulsatile high frequency stimulation apparatus for passive catheter according to the present invention.
  • 2 to 8 is a view for explaining the results of treatment through the extracorporeal pulsatile high frequency stimulation apparatus to which the present invention is applied.
  • the extracorporeal pulsatile high frequency stimulator for a passive catheter includes a therapeutic pulsatile high frequency signal generator 200 and a passive biograft catheter 300.
  • the pulsatile high frequency signal generator 200 for selecting a pulsatile high frequency signal according to a patient's condition converts the selected pulsatile high frequency signal into a therapeutic pulsatile high frequency signal, and transmits it through an antenna in a wireless form. .
  • Passive biograft catheter 300 is inserted into the body of the patient, and receives the therapeutic pulsatile high frequency signal through the antenna to cause electrical stimulation to occur in the site. That is, the basic implantation site is implanted in the sacral region of the pain patient.
  • two or more passive biograft catheter 300 may be implanted to determine the spinal cord region to be stimulated, and the implanted catheter may be controlled by the synchronization mode.
  • Service pulsatile high frequency signal generator 200 to select a frequency required for the treatment of pain or neurological abnormality, and requests for therapeutic pulsatile high frequency signal generation based on frequency information selected by physical force applied from the outside
  • the pulsatile high frequency generator 230 generates the pulsatile high frequency signal while generating and outputting an initial signal for treatment.
  • the control unit 220 to control the control unit, the pulsatile high frequency generator 230 generating and outputting a preset pulsatile high frequency signal according to the control of the control unit 220, and receiving the initial signal for treatment from the control unit 220
  • the pulsatile high frequency signal is input from the high frequency generator 230 and mixed into a therapeutic electrical signal, and the therapeutic electrical Pulsatile high frequency gateway 240 for outputting a signal, Pulsatile high frequency power amplifier 250 for receiving and amplifying a therapeutic electrical signal from the pulsatile high frequency gateway 240, and the amplified electrical signal for the treatment of the radio type
  • the wireless power control unit 260 converts the pulsatile high frequency signal and transmits it through the antenna 270, and the storage unit 280 storing the duration and treatment time information linked to the plurality of patient state information and the plurality of patient state information. Is made of.
  • the input unit 210 may be configured as a touch screen or a plurality of knob switches. When selecting a frequency for pain treatment, the input unit 210 serves to select a duration and treatment time of the frequency.
  • the input unit 210 when the input unit 210 forms a touch screen, the input unit 210 has the function of the output unit at the same time, and provides all menu items for generating pulsatile high frequency signals for controlling pain or nerve abnormality, and selecting menu items. To select and enter conditions.
  • the input unit 210 when the input unit 210 is composed of a plurality of knob switches, the output unit is provided separately, and the duration and treatment time can be selected by turning the knob switch on the basis of the pulsatile high frequency signal selection and the selected pulsatile high frequency signal.
  • the controller 220 recognizes this and outputs the current value of the knob switch through the output unit, so that the doctor or therapist can check and select the values while viewing it.
  • the interface unit 220 provides a plurality of patient state information through the input unit 210, and if one of the patient state information is selected, the interface screen for selecting the treatment frequency, duration, treatment time Can be provided.
  • the input unit 210 is provided in the form of a touch screen.
  • the controller 220 reads the information stored in the storage 280 to be provided through the input unit 210.
  • the wireless power control unit 260 allows high frequency matching with the antenna 310 connected to the passive biograft catheter 300 and monitors the output state of the therapeutic pulsatile high frequency signal transmitted through the antenna 270.
  • the doctor or therapist lays down the patient in the treatment bed, and then the duration of the high frequency signal and the high frequency signal suitable for treating pain or nerve abnormality of the patient through the input unit 210 of the pulsatile high frequency signal generator 200 for treatment. ), Set the treatment time (time).
  • Passive biograft catheter 300 equipped with an antenna 310 is implanted between the spine and the lumbar spine through the procedure.
  • the controller 220 recognizes the pulsatile high frequency generator 230 and presets the pulsatile high frequency signal. While generating a signal, an initial signal for treatment is generated based on the pulsatile high frequency signal, the duration of the pulsatile high frequency signal, and the treatment time information, which is set through the input unit 210, and is output to the pulsatile high frequency gateway 240. At this time, the pulsatile high frequency generator 230 also generates a pulsatile high frequency signal and outputs the pulsatile high frequency gateway 240.
  • the pulsatile high frequency gateway 240 mixes the initial signal for treatment and the pulsatile high frequency signal of the control unit 220 and converts it into a therapeutic electrical signal and outputs the pulsatile high frequency power amplifier 250.
  • the pulsatile high frequency power amplifier 250 amplifies the input therapeutic electrical signal and outputs it to the wireless power controller 260, and the wireless power controller 260 converts the amplified therapeutic electrical signal into a wireless signal to form an antenna.
  • the electrical signal for treatment in the form of a wireless signal transmitted through the antenna 270 and transmitted through the antenna 270 is received through the antenna 310 implanted in the body of the patient and applied to the electrode 320, and the electrode 320. ) Allows electrical stimulation to be performed through a pulsatile high frequency signal inside the patient's body.
  • the electrical stimulation is to relieve pain or neurological abnormalities of the patient, and can be treated for pain or neurological abnormalities when given periodically for a period of time.
  • FIG. 2 is a passive catheter of the present invention implanted in a patient complaining of urethral pain during urination, and initially "600sec 55V, 5Hz / 5ms, 300 ⁇ , 200mA done” condition through an in vitro pulsatile high frequency stimulator (FIG.
  • Pulmonary radiofrequency signals were applied to electrodes implanted in the sacral region between the spine and the lumbar vertebrae for 3 to 4 days. After one month of treatment, the pulsatile high frequency signal was removed using an in vitro pulsatile high frequency stimulator to have a "Pulsed RF 600sec 55V, 5Hz / 5ms, 300 ⁇ , 200mA done" condition (see FIG. 2 (b)). It was applied to the two electrodes so that the electrical stimulation is made to the area to treat the pain, the pain was improved.
  • Figure 3 is a patient complaining of fever in the pain and back around the anus, MRI (see Fig. 3 (a)) and a picture of the present invention (see Fig. 3 (b)), the pain when sitting in a hard place
  • the patient is appealing.
  • the patient who was treated by breaking the tailbone after falling only 3m from the patient, the patient was implanted with a passive catheter of the present invention, and the pulsed RF 600sec 55V, 5Hz / 5ms, 360 ⁇ , 150mA
  • the heat sensitivity of the back improves more than 30% and then
  • the pain in the tailbone was improved by 100% and 40 ⁇ 50% after 5 days more pain after treatment using pulsatile radiofrequency signal.
  • the pain in the tailbone was 70% better than in
  • Figure 4 shows that the whole arm is missing, we complain of pain at night, it is hard to fall asleep, pain in the left arm and left hand, lose weight, hard to stretch fingers, limp walking in limp because there is no strength in the left leg (Atrophic lateral sclerosis)
  • the patient was implanted with a passive catheter of the present invention, and the pulsatile high frequency signal having the condition "Pulsed RF 600sec 55V, 5Hz / 5ms, 182ohm, 304mA done" through an in vitro pulsatile radiofrequency stimulator was applied to the site. After the electrical stimulation treatment, the pain was eliminated and relaxed, the left arm pain improved from 70% to 85%, 0.5kg of dumbbell exercise was possible, Biceps increased, and no longer lost weight. It is possible to grab paper with the left hand, reduce the dim feeling when walking, and improve to walk 4 ⁇ 5km at a time.
  • 5 to 7 is a patient who is hospitalized for continuous rehabilitation treatment with neuropathic pain, the passive catheter of the present invention to a patient complaining of pain such as popping of the hands and feet and the pain of hot feeling such as burning on the back Using a pulsatile high frequency signal having a primary "Pulsed RF mode: 600sec, 55V, 5Hz / 20ms, 42 °C, 320 ⁇ " condition (see Fig. 5 (a)) through an in vitro pulsatile high frequency stimulator After performing the treatment to give electrical stimulation to the site as shown in Fig. 6 (a), the hand and foot and back pain after treatment fell the day after the procedure, after which there was a slight fluctuation, but appeared to be lower than before the procedure. As shown in Fig.

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Abstract

The present invention relates to a passive in vitro pulsatile high-frequency stimulator enabling the modulation of pain or a neurological abnormality of a patient by means of, according to the symptoms of the patient, generating a pulsatile high frequency according to an appropriate algorithm, and transmitting the generated pulsatile high-frequency energy to a catheter implanted in vivo so as to modulate pain or a neurological abnormality, the present invention comprising: a pulsatile high-frequency signal generator for treatment enabling the selection of a pulsatile high-frequency signal according to the state of the patient, converting the selected pulsatile high-frequency signal into a pulsatile high-frequency signal for treatment, then converting same into a wireless form and transmitting same through an antenna; and an electrode receiving the pulsatile high-frequency signal for treatment through the antenna of a passive bio-implant-type catheter inserted inside the body of the patient, and enabling the generation of an electric stimulus on a corresponding site. Further, a synchronization mode may be serviced for stimulus-synchronizing two passive bio-implant-type catheters for inserting the two passive bio-implant-type catheters in vivo and stimulating a desired spinal nerve interval. As such, the present invention has the effect of not only enabling the alleviation of pain or a neurological abnormality of a patient, but also improving pain treatment or neuromodulation treatment for a neurological abnormality.

Description

수동형 생체이식 경천추 경막외 척수신경 자극을 위한 카테터용 박동성 고주파 자극장치Pulsatile High Frequency Stimulator for Catheter for Passive Biological Cervical Spine Epidural Spinal Nerve Stimulation
본 발명은 수동형 생체이식 경천추 경막외 척수신경 자극을 위한 카테터용 박동성 고주파 자극장치(이하 수동형 카테타용 체외 박동성 고주파 자극장치)에 관한 것으로, 특히 환자의 증상에 따라 적절한 알고리즘에 의한 박동성 고주파의 발생과 발생된 박동성 고주파 에너지로 통증이나 신경 이상 조절을 할 수 있도록 체내 이식된 카테타에 전달하여 환자로 하여금 통증이나 신경 이상 조절을 할 수 있도록 하는 수동형 체외 박동성 고주파 자극장치에 관한 것이다.The present invention relates to a pulsatile radiofrequency stimulator for a catheter for passive biograft cervical epidural spinal nerve stimulation (hereinafter referred to as an pulsatile radiofrequency stimulator for passive catheter), in particular the generation of pulsatile radiofrequency by an appropriate algorithm according to the patient's symptoms. The present invention relates to a passive extracorporeal pulsatile radiofrequency stimulator which transmits to a catheter implanted in the body so as to control pain or neuronal abnormality with the generated pulsatile radiofrequency energy.
박동성 고주파는 다양한 만성통증 증후군의 치료를 위해 사용되어 왔다. 지속성 고주파에 비하여 신경손상이 거의 없는 장점이 있어, 최근 신경조절치료기로 부각되고 있다. 또한 만성 통증 질환을 가진 고령의 환자들에게 반복주사로 인해 다양한 합병증을 유발할 수 있는 스테로이드 주사를 피할 수 있는 도구로 볼 수 있다. 경추부와 요추부 후근신경절, 척추후지내측지 등에 박동성 고주파를 시행해 오던 것을 다양한 약물 치료에도 만족할만한 통증의 호전을 보이지 않는 만성 난치성 신경병증성 통증인 삼차신경통, 척추수술후 실패증후군, 복합부위 통증증후군, 대상포진 후 신경통증 등의 치료를 위해 척추신경, 얼굴 및 체간, 사지의 말초신경 박동성 고주파 치료가 확대되어 가고 있는 추세이다. 최근에는 관절강내 박동성 고주파를 시행하여 만성 관절통증을 감소시키는 효과가 있음이 보고되었다. 관절강내 박동성 고주파는 신경조직에 직접 작용하는 것이 아니라 관절강내 조직에 작용하여 항염증 작용, 면역세포 조절 작용을 하는 것을 추정된다.Pulsatile radiofrequency has been used for the treatment of various chronic pain syndromes. Compared with persistent high frequency, there is almost no nerve damage, and it has recently emerged as a neuromodulator. It can also be seen as a tool to avoid steroid injections in elderly patients with chronic pain disorders, which can cause various complications due to repeated injections. Tricuspid neuralgia, failure syndrome after spinal surgery, complex site pain syndrome For the treatment of postherpetic neuralgia, peripheral nerve pulsatile radiofrequency therapy of spinal nerve, face and trunk and limbs is expanding. Recently, intraarticular pulsatile radiofrequency has been reported to reduce chronic joint pain. Intra-articular pulsatile radiofrequency is expected to act on intra-articular tissues rather than directly on nerve tissues to act as an anti-inflammatory and immune cell regulator.
수핵탈출 동물모델을 이용하여 신경병증성 통증을 유발시킨 동물의 척추 후근신경절(dorsal root ganglion)에 박동성 고주파를 시행할 경우, 척추 후각(dorsal horn)에서 신경통증 발현에 중요하다고 알려져 있는 미세교세포(microglia), 성상신경세포(astrocyte), P 물질(substance P) 등의 활성이 감소되는 것이 밝혀져 있다. 말초신경이나 관절 등의 통증이 지속될 경우 중추신경인 척수와 뇌의 통증 지각 부위가 과민하게 되어 중심성 감작화(central sensitization)가 발생하게 되는데, 중심성 감작화는 미세교세포 등의 활성화가 관여하게 된다. 중심성 감작화가 생기면 국소 부위의 통증이 점차 확대되어 넓은 부위로 통증이 퍼지고, 사소한 자극에도 통증의 발생하거나 자발통이 심해지며 어떠한 치료에도 잘 반응하지 않게 된다.Micropulmonary cells, known to be important for the development of neuropathic pain in the dorsal horn, when pulsatile radiofrequency ablation is performed on the dorsal root ganglion of animals with neuropathic pain, It has been found that the activity of microglia), astrocytes, and substance P (substance P) are reduced. Peripheral nerves and joint pain, such as the central nervous system spinal cord and the pain perception of the brain becomes sensitive and central sensitization occurs, the central sensitization is involved in the activation of microglia. Central sensitization causes the pain in the local area to gradually expand, spreading the pain over a wide area, causing pain or spontaneous pain even with minor irritation and not responding well to any treatment.
이러한 난치성 통증을 근원적으로 줄이기 위해선 미세교세포의 활성을 감소시키는 박동성 고주파치료가 필요하다. 이미 확산된 중추신경의 감작화를 치료하기 위해선 국소 부위 신경에 대한 단회성 박동성 고주파 치료에는 잘 반응하지 않아 척수의 전장에 걸친 신경의 박동성 고주파 치료가 필요하다. 또한 이러한 경막외 척추신경 단회성 박동성 고주파 치료에 반응을 한다고 하더라도 통증 감소나 신경이상 조절 효과가 오랫동안 지속되지는 않으므로 생체 이식형 카테타를 삽입하여 환자의 통증이나 신경 이상을 지속적으로 조절 수 있는 박동성 고주파 자극장치가 필요하다.To fundamentally reduce such intractable pain, pulsatile radiofrequency therapy that reduces the activity of microglia is required. In order to treat the sensitization of the central nerve that has already spread, pulsatile radiofrequency treatment of the nerves over the entire length of the spinal cord is required because it does not respond well to single-time pulsatile radiotherapy for local nerves. In addition, even if responding to the epidural spinal nerve pulsatile pulsatile radiofrequency therapy, pain reduction or neuronal dysregulation effect does not last for a long time, so the pulsatile radiofrequency that can continuously control the pain or nerve abnormality of the patient by inserting a living implantable catheter A stimulation device is needed.
기존의 삽입형 척수신경자극술에서는 30~150Hz의 저주파 전기자극을 사용하나, 최근에는 10,000Hz 전기자극기가 개발되어 좀 더 나은 치료 결과를 보인다는 보고가 있다.Conventional spinal nerve stimulation uses low frequency electric stimulation of 30 ~ 150Hz, but recently it has been reported that 10,000Hz electric stimulator has been developed to show better treatment results.
그러나, 저주파 자극에 비해 치료효과가 좋은 500,000Hz의 고주파를 박동성으로 자극함으로써, 중심성 감작화가 된 만성 난치성 통증 치료나 신경 이상 조절을 위해 척추 전장에 걸쳐 자극을 할 수 있는 생체 이식형 경천추 경막외 척수신경 자극용 카테타를 위한 박동성 고주파 장치가 필요하게 되었다.However, pulsatile stimulation of high frequency of 500,000Hz, which is more effective than low frequency stimulation, is a biograft cervical epidural that can be stimulated throughout the spinal field to treat centralized sensitized chronic intractable pain or to control nerve abnormalities. There is a need for a pulsatile radiofrequency device for a catheter for spinal nerve stimulation.
이와 같은 문제점을 해소시키기 위해 본 발명은 환자의 증상에 따라 적절한 알고리즘에 의한 박동성 고주파의 발생과 발생된 박동성고주파 에너지를 통증이나 신경 이상을 조절할 수 있도록 체내 이식된 카테타에 전달하여 환자로 하여금을 통증을 조절할 수 있도록 하는 수동형 카테타를 위한 체외 박동성 고주파 자극장치를 제공하는데 목적이 있다.In order to solve this problem, the present invention transmits the generated pulsatile high frequency and the generated pulsatile high frequency energy to the catheter implanted in the body so as to control the pain or nerve abnormality according to the patient's symptoms, thereby causing the patient's pain. An object of the present invention is to provide an extracorporeal pulsatile radiofrequency stimulator for a passive catheter.
본 발명의 실시예에 따른 수동형 카테타를 위한 체외 박동성 고주파 자극장치는 환자상태에 따라 박동성고주파 신호를 선정할 수 있도록 하고, 선정된 박동성고주파 신호 정보를 치료용 박동성고주파 신호로 변환시킨 후 무선형태로 변환시켜 안테나를 통해 송출하는 치료용 박동성 고주파신호 발생장치; 체내 이식된 안테나를 통해 치료용 박동성 고주파신호를 수신받아 해당 부위에 전기적 자극이 발생되도록 하는 수동형 생체이식형 카테타를 포함할 수 있다.The extracorporeal pulsatile high frequency stimulation apparatus for passive catheter according to an embodiment of the present invention allows the pulsatile high frequency signal to be selected according to the patient's condition, and converts the selected pulsatile high frequency signal information into a therapeutic pulsatile high frequency signal in a wireless form. Therapeutic pulsatile high frequency signal generator for converting and transmitting through the antenna; Receiving a therapeutic pulsatile high frequency signal through the implanted antenna in the body may include a passive biograft catheter to generate an electrical stimulation to the site.
본 발명과 관련된 실시예로서, 치료용 박동성고주파신호 발생장치가 통증이나 신경 이상 조절 치료에 필요한 주파수를 선정할 수 있도록 서비스하고, 외부로부터 가해지는 물리적인 힘에 의해 선정된 주파수 정보를 기반으로 치료용 박동성 고주파신호 발생요청신호를 생성시켜 출력하는 입력부와, 입력부로부터 치료용 박동성 고주파신호 발생요청신호가 입력되면 치료용 초기 신호를 발생시켜 출력하는 한편 박동성 고주파신호 발생부가 박동성 고주파신호를 발생시키도록 제어하는 제어부와, 제어부의 제어에 응하여 미리 설정된 박동성고주파신호를 발생시켜 출력하는 박동성고주파신호 발생부와, 제어부로부터 치료용 초기신호를 입력받고, 상기 박동성 고주파신호 발생부로부터 박동성고주파신호 정보를 입력받아 혼합시켜 치료용 전기적 신호로 변환시키고, 치료용 전기적 신호를 출력하는 박동성 고주파 게이트웨이와, 박동성 고주파 게이트웨이로부터 치료용 전기적 신호를 입력받아 증폭시키는 박동성고주파 전력증폭부와, 증폭된 치료용 전기적 신호를 무선형태의 치료용 박동성고주파신호로 변환시켜 안테나를 통해 송출하는 무선전력 제어부로 이루어질 수 있다.In an embodiment related to the present invention, a therapeutic pulsatile high frequency signal generator provides a service for selecting a frequency required for treatment of pain or neuropathy control, and treatment based on frequency information selected by a physical force applied from the outside. And an input unit for generating and outputting a pulsatile high frequency signal generation request signal, and generating and outputting an initial signal for treatment when a therapeutic pulsatile high frequency signal generation request signal is input from the input unit, while causing the pulsatile high frequency signal generator to generate a pulsatile high frequency signal. A control unit for controlling, a pulsating high frequency signal generating unit for generating and outputting a preset pulsating high frequency signal according to the control of the control unit, an initial signal for treatment from the control unit, and receiving pulsatile high frequency signal information from the pulsating high frequency signal generating unit Receive and mix to treat electrical scene Is a pulsatile high frequency gateway that converts the signal into a therapeutic signal and outputs a therapeutic electrical signal, a pulsatile high frequency power amplifier that receives and amplifies a therapeutic electrical signal from the pulsatile high frequency gateway, and converts the amplified electrical signal into a radio frequency therapeutic pulsatile high frequency. It may be made of a wireless power control unit for converting the signal to be transmitted through the antenna.
본 발명과 관련된 실시예로서, 2개의 수동형 생체이식형 카테타를 체내에 삽입하여 원하는 척수 신경구간을 자극하기 위해 2개의 수동형 생체이식형 카테타의 자극 동기화를 위하여 2개의 치료용 박동성 고주파신호 발생장치를 동기화 모드로 서비스할 수 있다. In an embodiment related to the present invention, two therapeutic pulsatile high frequency signal generators are inserted for stimulation synchronization of two passive biograft catheters to insert two passive biograft catheters into the body to stimulate a desired spinal cord nerve segment. You can service in synchronization mode.
본 발명과 관련된 실시예로서, 입력부가 통증치료에 필요한 주파수를 선정 시, 주파수의 듀레이션(duration) 및 치료시간을 선정할 수 있도록 서비스할 수 있다.As an embodiment related to the present invention, when the input unit selects a frequency required for pain treatment, it may serve to select a duration and treatment time of the frequency.
본 발명과 관련된 실시예로서, 제어부가, 입력부를 통해 복수의 환자상태정보를 제공하고, 환자상태정보 중 하나의 환자상태정보가 선택되면 해당 치료용 주파수, 듀레이션, 치료시간을 선정할 수 있도록 서비스하는 인터페이스 화면이 제공되도록 할 수 있다.In an embodiment related to the present invention, the control unit provides a plurality of patient state information through an input unit, and if one of the patient state information is selected, the service for selecting a corresponding treatment frequency, duration, treatment time The interface screen can be provided.
본 발명과 관련된 실시예로서, 치료용 박동성 고주파신호 발생장치가, 복수의 환자상태정보 및 복수의 환자상태정보에 듀레이션 및 치료시간정보들을 링크시켜 저장하고 있는 저장부를 더 포함하고 있으며, 제어부가, 저장부에 저장된 정보들을 읽어들여 입력부를 통해 제공되도록 할 수 있다.As an embodiment related to the present invention, the treatment pulsatile high frequency signal generator further comprises a storage unit for storing the duration and treatment time information linked to the plurality of patient state information and the plurality of patient state information, the control unit, Information stored in the storage may be read and provided through the input unit.
본 발명과 관련된 실시예로서, 입력부가 터치스크린 형태로 제공될 수 있다.In an embodiment related to the present invention, the input unit may be provided in the form of a touch screen.
본 발명과 관련된 실시예로서, 무선전력 제어부가, 전극에 연결된 안테나와의 고주파 정합이 이루어지도록 하고, 안테나를 통해 송출되는 치료용 박동성고주파 신호의 출력상태를 모니터링할 수 있다.In an embodiment related to the present invention, the wireless power control unit may perform high frequency matching with an antenna connected to an electrode, and may monitor an output state of a therapeutic pulsatile high frequency signal transmitted through the antenna.
본 발명과 관련된 실시예로서, 체내 이식된 수동형 생체이식형 카테타의 안테나를 통해 치료용 박동성 고주파 신호를 수신받아 해당 부위에 전기적 자극이 발생되도록 할 수 있다.In an embodiment related to the present invention, an electrical stimulation may be generated at a corresponding site by receiving a pulsatile high frequency signal through an antenna of a passive biograft catheter implanted in the body.
본 발명은 환자의 증상에 따라 적절한 알고리즘에 의한 박동성 고주파의 발생과 발생된 박동성고주파 에너지를 통증이나 신경 이상을 조절할 수 있도록 체내 이식된 카테타에 전달하여 환자로 하여금을 통증을 조절할 수 있도록 함으로써, 환자의 통증이나 신경 이상을 완화시키는 효과가 있다.The present invention transmits the generated pulsatile radiofrequency by the appropriate algorithm and the generated pulsatile high frequency energy according to the symptoms of the patient to the implanted catheter to control the pain or nerve abnormality, thereby allowing the patient to control the pain. It is effective in relieving pain and nerve abnormalities.
또한, 본 발명은 체외에서 비 침습적으로 치료에 필요한 박동성 고주파 신호를 발생시켜 전달할 수 있도록 함으로써, 환자에게 고주파 바늘을 삽입할 때마다 발생되는 불필요한 고통을 제거할 수 있으며, 환자의 증상에 따라 적절하게 통증이나 신경 이상을 제어하여 치료할 수 있도록 하는 효과가 있다.In addition, the present invention can generate and transmit a pulsatile high frequency signal required for treatment in vitro and non-invasive, thereby eliminating unnecessary pain generated every time a high frequency needle is inserted into the patient, and appropriately according to the symptoms of the patient. It is effective in controlling pain or nerve abnormalities.
도 1은 본 발명에 따른 수동형 카테타용 체외 박동성 고주파 자극장치의 구성을 설명하기 위한 블록도이다.1 is a block diagram for explaining the configuration of the in vitro pulsatile high frequency stimulation apparatus for passive catheter according to the present invention.
도 2 내지 도 8은 본 발명이 적용된 체외 박동성 고주파 자극장치를 통해 치료한 결과를 설명하기 위한 도면이다.2 to 8 is a view for explaining the results of treatment through the extracorporeal pulsatile high frequency stimulation apparatus to which the present invention is applied.
본 발명에서 사용되는 기술적 용어는 단지 특정한 실시 예를 설명하기 위해 사용된 것으로, 본 발명을 한정하려는 의도가 아님을 유의해야 한다. 또한, 본 발명에서 사용되는 기술적 용어는 본 발명에서 특별히 다른 의미로 정의되지 않는 한, 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자에 의해 일반적으로 이해되는 의미로 해석되어야 하며, 과도하게 포괄적인 의미로 해석되거나, 과도하게 축소된 의미로 해석되지 않아야 한다. 또한, 본 발명에서 사용되는 기술적인 용어가 본 발명의 사상을 정확하게 표현하지 못하는 잘못된 기술적 용어일 때에는, 당업자가 올바르게 이해할 수 있는 기술적 용어로 대체되어 이해되어야 할 것이다. 또한, 본 발명에서 사용되는 일반적인 용어는 사전에 정의되어 있는 바에 따라, 또는 전후 문맥상에 따라 해석되어야 하며, 과도하게 축소된 의미로 해석되지 않아야 한다.Technical terms used in the present invention are merely used to describe specific embodiments, it should be noted that it is not intended to limit the present invention. In addition, the technical terms used in the present invention should be interpreted as meanings generally understood by those skilled in the art unless the present invention has a special meaning defined in the present invention, and is excessively comprehensive. It should not be interpreted in the sense of or in the sense of being excessively reduced. In addition, when a technical term used in the present invention is an incorrect technical term that does not accurately express the spirit of the present invention, it should be replaced with a technical term that can be properly understood by those skilled in the art. In addition, the general terms used in the present invention should be interpreted as defined in the dictionary or according to the context before and after, and should not be interpreted in an excessively reduced sense.
또한, 본 발명에서 사용되는 단수의 표현은 문맥상 명백하게 다르게 뜻하지 않는 한 복수의 표현을 포함한다. 본 발명에서, "구성된다" 또는 "포함한다" 등의 용어는 발명에 기재된 여러 구성 요소들, 또는 여러 단계를 반드시 모두 포함하는 것으로 해석되지 않아야 하며, 그 중 일부 구성 요소들 또는 일부 단계들은 포함되지 않을 수도 있고, 또는 추가적인 구성 요소 또는 단계들을 더 포함할 수 있는 것으로 해석되어야 한다.Also, the singular forms used in the present invention include plural forms unless the context clearly indicates otherwise. In the present invention, terms such as “consisting of” or “comprising” should not be construed as necessarily including all of the various components or steps described in the invention, and some of the components or some of the steps are included. It should be construed that it may not be, or may further include additional components or steps.
이하, 첨부된 도면을 참조하여 본 발명에 따른 바람직한 실시 예를 상세히 설명하되, 도면 부호에 관계없이 동일하거나 유사한 구성 요소는 동일한 참조 번호를 부여하고 이에 대한 중복되는 설명은 생략하기로 한다.Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings, and the same or similar components will be given the same reference numerals regardless of the reference numerals, and redundant description thereof will be omitted.
또한, 본 발명을 설명함에 있어서 관련된 공지 기술에 대한 구체적인 설명이 본 발명의 요지를 흐릴 수 있다고 판단되는 경우 그 상세한 설명을 생략한다. In addition, in describing the present invention, when it is determined that the detailed description of the related known technology may obscure the gist of the present invention, the detailed description thereof will be omitted.
또한, 첨부된 도면은 본 발명의 사상을 쉽게 이해할 수 있도록 하기 위한 것일 뿐, 첨부된 도면에 의해 본 발명의 사상이 제한되는 것으로 해석되어서는 아니 됨을 유의해야 한다.In addition, it should be noted that the accompanying drawings are only for easily understanding the spirit of the present invention and should not be construed as limiting the spirit of the present invention by the accompanying drawings.
도 1은 본 발명에 따른 수동형 카테타용 체외 박동성 고주파 자극장치의 구성을 설명하기 위한 블록도이다. 도 2 내지 도 8은 본 발명이 적용된 체외 박동성 고주파 자극장치를 통해 치료한 결과를 설명하기 위한 도면이다.1 is a block diagram for explaining the configuration of the in vitro pulsatile high frequency stimulation apparatus for passive catheter according to the present invention. 2 to 8 is a view for explaining the results of treatment through the extracorporeal pulsatile high frequency stimulation apparatus to which the present invention is applied.
도 1에 도시된 바와 같이 수동형 카테타용 체외 박동성 고주파 자극장치는 치료용 박동성고주파 신호 발생장치(200) 및 수동형 생체이식형 카테타(300)으로 이루어진다.As shown in FIG. 1, the extracorporeal pulsatile high frequency stimulator for a passive catheter includes a therapeutic pulsatile high frequency signal generator 200 and a passive biograft catheter 300.
치료용 박동성고주파 신호 발생장치(200)는 환자상태에 따라 박동성고주파 신호를 선정할 수 있도록 하고, 선정된 박동성고주파 신호를 치료용 박동성고주파 신호로 변환시킨 후 무선형태로 변환시켜 안테나를 통해 송출한다.The pulsatile high frequency signal generator 200 for selecting a pulsatile high frequency signal according to a patient's condition, converts the selected pulsatile high frequency signal into a therapeutic pulsatile high frequency signal, and transmits it through an antenna in a wireless form. .
수동형 생체이식형 카테타(300)는 환자의 몸속에 삽입되어 있으며, 안테나를 통해 치료용 박동성고주파 신호를 수신받아 해당 부위에 전기적 자극이 발생되도록 한다. 즉, 기본적인 이식위치는 통증환자의 천추 부위에 이식된다. Passive biograft catheter 300 is inserted into the body of the patient, and receives the therapeutic pulsatile high frequency signal through the antenna to cause electrical stimulation to occur in the site. That is, the basic implantation site is implanted in the sacral region of the pain patient.
그러나 환자의 상태에 따라서 2 개 이상의 수동형 생체이식형 카테타(300)를 이식하여 자극 하고자 하는 척수 구간을 정할 수 있으며, 이식된 카테타는 동기화모드에 의해 제어할 수 있다.However, according to the patient's condition, two or more passive biograft catheter 300 may be implanted to determine the spinal cord region to be stimulated, and the implanted catheter may be controlled by the synchronization mode.
치료용 박동성고주파 신호 발생장치(200)가 통증이나 신경 이상 치료에 필요한 주파수를 선정할 수 있도록 서비스하고, 외부로부터 가해지는 물리적인 힘에 의해 선정된 주파수 정보를 기반으로 치료용 박동성고주파신호 발생요청신호를 생성시켜 출력하는 입력부(210)와, 입력부(210)로부터 치료용 박동성 고주파신호 발생신호가 입력되면 치료용 초기 신호를 발생시켜 출력하는 한편 박동성 고주파 발생부(230)가 박동성 고주파신호를 발생시키도록 제어하는 제어부(220)와, 제어부(220)의 제어에 응하여 미리 설정된 박동성 고주파신호를 발생시켜 출력하는 박동성 고주파 발생부(230)와, 제어부(220)로부터 치료용 초기신호를 입력받고 박동성고주파 발생부(230)로부터 박동성고주파신호를 입력받아 혼합시켜 치료용 전기적 신호로 변환시키고, 치료용 전기적 신호를 출력하는 박동성 고주파 게이트웨이(240)와, 박동성 고주파 게이트웨이(240)로부터 치료용 전기적 신호를 입력받아 증폭시키는 박동성고주파 전력증폭부(250)와, 증폭된 치료용 전기적 신호를 무선형태의 치료용 박동성고주파신호로 변환시켜 안테나(270)를 통해 송출하는 무선전력 제어부(260)와, 복수의 환자상태정보 및 복수의 환자상태정보에 듀레이션 및 치료시간정보들을 링크시켜 저장하고 있는 저장부(280)로 이루어진다.Service pulsatile high frequency signal generator 200 to select a frequency required for the treatment of pain or neurological abnormality, and requests for therapeutic pulsatile high frequency signal generation based on frequency information selected by physical force applied from the outside When the treatment pulsatile high frequency signal generation signal is input from the input unit 210 to generate and output a signal, the pulsatile high frequency generator 230 generates the pulsatile high frequency signal while generating and outputting an initial signal for treatment. The control unit 220 to control the control unit, the pulsatile high frequency generator 230 generating and outputting a preset pulsatile high frequency signal according to the control of the control unit 220, and receiving the initial signal for treatment from the control unit 220 The pulsatile high frequency signal is input from the high frequency generator 230 and mixed into a therapeutic electrical signal, and the therapeutic electrical Pulsatile high frequency gateway 240 for outputting a signal, Pulsatile high frequency power amplifier 250 for receiving and amplifying a therapeutic electrical signal from the pulsatile high frequency gateway 240, and the amplified electrical signal for the treatment of the radio type The wireless power control unit 260 converts the pulsatile high frequency signal and transmits it through the antenna 270, and the storage unit 280 storing the duration and treatment time information linked to the plurality of patient state information and the plurality of patient state information. Is made of.
입력부(210)가 터치스크린 형태 또는 복수의 노브 스위치들로 이루어져 있을 수 있으며, 통증치료에 필요한 주파수를 선정 시, 주파수의 듀레이션(duration) 및 치료시간을 함께 선정할 수 있도록 서비스한다.The input unit 210 may be configured as a touch screen or a plurality of knob switches. When selecting a frequency for pain treatment, the input unit 210 serves to select a duration and treatment time of the frequency.
즉 입력부(210)가 터치스크린 형태를 이룰 경우 입력부(210)는 출력부의 기능을 동시에 가지게 되며, 통증이나 신경 이상 조절을 위한 박동성 고주파 신호를 발생시키기 위한 모든 메뉴항목을 제공하고, 메뉴항목을 선택하여 조건을 선택하여 입력할 수 있도록 서비스한다. 한편 입력부(210)가 복수의 노브 스위치들로 이루어지는 경우 출력부가 별도로 구비되어 있으며, 박동성고주파 신호 선정 및 선정된 박동성고주파 신호를 기반으로 하여 듀레이션 및 치료시간 등을 노브 스위치를 돌려서 선정할 수 있도록 하며, 노브 스위치를 회전시키면 제어부(220)가 이를 인식하여 출력부를 통해 노브 스위치의 현재 값을 출력시키고, 의사나 또는 치료자가 이를 보면서 확인하고 값들을 선정할 수 있도록 구현 가능하다.That is, when the input unit 210 forms a touch screen, the input unit 210 has the function of the output unit at the same time, and provides all menu items for generating pulsatile high frequency signals for controlling pain or nerve abnormality, and selecting menu items. To select and enter conditions. On the other hand, when the input unit 210 is composed of a plurality of knob switches, the output unit is provided separately, and the duration and treatment time can be selected by turning the knob switch on the basis of the pulsatile high frequency signal selection and the selected pulsatile high frequency signal. When the knob switch is rotated, the controller 220 recognizes this and outputs the current value of the knob switch through the output unit, so that the doctor or therapist can check and select the values while viewing it.
제어부(220)가 입력부(210)를 통해 복수의 환자상태정보를 제공하고, 환자상태정보 중 하나의 환자상태정보가 선택되면 해당 치료용 주파수, 듀레이션, 치료시간을 선정할 수 있도록 서비스하는 인터페이스 화면이 제공되도록 할 수 있다. 즉 이 경우 입력부(210)가 터치스크린 형태로 제공되는 경우에 해당된다.The interface unit 220 provides a plurality of patient state information through the input unit 210, and if one of the patient state information is selected, the interface screen for selecting the treatment frequency, duration, treatment time Can be provided. In this case, the input unit 210 is provided in the form of a touch screen.
제어부(220)가 저장부(280)에 저장된 정보들을 읽어들여 입력부(210)를 통해 제공되도록 한다.The controller 220 reads the information stored in the storage 280 to be provided through the input unit 210.
무선전력 제어부(260)가 수동형 생체이식형 카테타300)에 연결된 안테나(310)와의 고주파 정합이 이루어지도록 하고, 안테나(270)를 통해 송출되는 치료용 박동성 고주파 신호의 출력상태를 모니터링한다.The wireless power control unit 260 allows high frequency matching with the antenna 310 connected to the passive biograft catheter 300 and monitors the output state of the therapeutic pulsatile high frequency signal transmitted through the antenna 270.
상기와 같이 구성된 수동형 카테타용 체외 박동성 고주파 자극장치의 작용에 대해서 설명하면 다음과 같다.Referring to the operation of the extracorporeal pulsatile high frequency stimulation device for a passive catheter configured as described above are as follows.
먼저 의사 또는 치료자가 환자를 치료 침대에 엎드리는 자세로 눕힌 후 치료용 박동성고주파 신호 발생장치(200)의 입력부(210)를 통해 환자의 통증이나 신경 이상 치료에 적합한 고주파 신호, 고주파 신호의 듀레이션(duration), 치료시간(time)을 설정한다.First, the doctor or therapist lays down the patient in the treatment bed, and then the duration of the high frequency signal and the high frequency signal suitable for treating pain or nerve abnormality of the patient through the input unit 210 of the pulsatile high frequency signal generator 200 for treatment. ), Set the treatment time (time).
안테나(310)가 구비된 수동형 생체이식형 카테타(300)는 시술을 통해 척추와 미추 사이에 이식되어 있다. Passive biograft catheter 300 equipped with an antenna 310 is implanted between the spine and the lumbar spine through the procedure.
위에서 기재한 바와 같이 입력부(210)릍 통해 박동성 고주파신호, 박동성 고주파신호의 듀레이션, 치료시간이 설정되면, 제어부(220)는 이를 인식하여 박동성고주파 발생부(230)를 통해 미리 설정되어 있는 박동성 고주파신호를 발생시키는 한편, 입력부(210)를 통해 설정된 박동성 고주파신호, 박동성 고주파신호의 듀레이션, 치료시간 정보를 기반으로 치료용 초기신호를 발생시켜 박동성 고주파 게이트웨이(240)로 출력한다. 이때 박동성 고주파 발생부(230)도 박동성 고주파신호를 발생시켜 박동성 고주파 게이트웨이(240)로 출력한다.As described above, when the pulsatile high frequency signal, the duration of the pulsatile high frequency signal, and the treatment time are set through the input unit 210 제어부, the controller 220 recognizes the pulsatile high frequency generator 230 and presets the pulsatile high frequency signal. While generating a signal, an initial signal for treatment is generated based on the pulsatile high frequency signal, the duration of the pulsatile high frequency signal, and the treatment time information, which is set through the input unit 210, and is output to the pulsatile high frequency gateway 240. At this time, the pulsatile high frequency generator 230 also generates a pulsatile high frequency signal and outputs the pulsatile high frequency gateway 240.
그러면 박동성 고주파 게이트웨이(240)는 제어부(220)의 치료용 초기신호와 박동성고주파 신호를 혼합시킨 후 치료용 전기적 신호로 변환시켜 박동성 고주파 전력증폭부(250)로 출력한다.Then, the pulsatile high frequency gateway 240 mixes the initial signal for treatment and the pulsatile high frequency signal of the control unit 220 and converts it into a therapeutic electrical signal and outputs the pulsatile high frequency power amplifier 250.
박동성 고주파 전력증폭부(250)는 입력된 치료용 전기적 신호를 증폭시킨 후 무선전력 제어부(260)로 출력하고, 무선전력 제어부(260)는 증폭된 치료용 전기적 신호를 무선신호 형태로 변환시켜 안테나(270)를 통해 송출시키고, 안테나(270)를 통해 송출된 무선신호 형태의 치료용 전기적 신호는 환자의 몸속에 이식된 안테나(310)를 통해 수신되어 전극(320)으로 인가되고, 전극(320)은 환자 몸속 내부에 박동성 고주파 신호를 통해 전기적 자극이 이루어지도록 한다. 이러한 전기적 자극은 환자의 통증이나 신경 이상을 완화시켜 주게 되고, 주기적으로 일정 기간 제공받게 되는 경우 통증이나 신경 이상을 치료할 수 있게 된다.The pulsatile high frequency power amplifier 250 amplifies the input therapeutic electrical signal and outputs it to the wireless power controller 260, and the wireless power controller 260 converts the amplified therapeutic electrical signal into a wireless signal to form an antenna. The electrical signal for treatment in the form of a wireless signal transmitted through the antenna 270 and transmitted through the antenna 270 is received through the antenna 310 implanted in the body of the patient and applied to the electrode 320, and the electrode 320. ) Allows electrical stimulation to be performed through a pulsatile high frequency signal inside the patient's body. The electrical stimulation is to relieve pain or neurological abnormalities of the patient, and can be treated for pain or neurological abnormalities when given periodically for a period of time.
도 2는 배뇨시 요도 통증을 호소하는 환자에 대해서 본 발명인 수동형 카테타를 이식하고, 체외 박동성 고주파 자극장치를 통해 처음에는 "600sec 55V, 5Hz/5ms, 300Ω, 200mA done" 조건(도 2의 (a) 참조)을 가지도록 박동성 고주파 신호를 환자의 척추와 미추 사이인 천추 부위에 이식된 전극으로 인가시키는 치료를 3~4일 지속적으로 한 경우로서 배뇨통증이 40% 호전되어, 비교적 편안하게 소변을 볼 수 있는 상태로 치료되었으며, 한달 후 체외 박동성 고주파 자극장치를 통해 "Pulsed RF 600sec 55V, 5Hz/5ms, 300Ω, 200mA done" 조건(도 2의 (b) 참조)을 가지도록 박동성 고주파 신호를 제 2 전극으로 인가시켜 해당 부위에 전기적 자극이 이루어지도록 하여 통증을 치료하여, 통증이 호전되었다.FIG. 2 is a passive catheter of the present invention implanted in a patient complaining of urethral pain during urination, and initially "600sec 55V, 5Hz / 5ms, 300Ω, 200mA done" condition through an in vitro pulsatile high frequency stimulator (FIG. Pulmonary radiofrequency signals were applied to electrodes implanted in the sacral region between the spine and the lumbar vertebrae for 3 to 4 days. After one month of treatment, the pulsatile high frequency signal was removed using an in vitro pulsatile high frequency stimulator to have a "Pulsed RF 600sec 55V, 5Hz / 5ms, 300Ω, 200mA done" condition (see FIG. 2 (b)). It was applied to the two electrodes so that the electrical stimulation is made to the area to treat the pain, the pain was improved.
도 3은 항문 주위 통증 및 등에서 열이 난다고 호소하는 환자로서, MRI 사진(도 3의 (a) 참조)과 본 발명을 시술한 사진(도 3의 (b) 참조)으로서, 딱딱한 곳에 앉으면 통증을 호소하는 환자이다. 이 환자의 겨우 3m 높이에서 떨어진 이후 꼬리뼈가 부러져 치료를 받았던 환자의 경우로서, 환자에게 본 발명인 수동형 카테타를 이식하고, 체외 박동성 고주파 자극장치를 통해 "Pulsed RF 600sec 55V, 5Hz/5ms, 360Ω, 150mA done"의 조건을 가지는 박동성 고주파 신호를 척추 및 미추 사이에 이식된 전극으로 송출시켜 박동성 고주파 신호를 이용하여 해당 부위에 전기적 자극을 30분동안 가해준 후 등의 열감이 30%이상 호전되고 그 이후 100%로 호전되었으며, 꼬리뼈쪽의 통증은 박동성 고주파 신호를 이용하여 치료한 후 5일 정도 더 아픈 후 40~50% 정도 호전되었다. 이러한 박동성 고주파 신호를 이용하여 한달 정도 치료한 후 꼬리뼈쪽 통증은 처음에 비해 70% 호전되었으며, 등에 열나는 느낌은 거의 없고, 좌측 팔쪽으로만 약간 남아 있는 것으로 확인되었다.Figure 3 is a patient complaining of fever in the pain and back around the anus, MRI (see Fig. 3 (a)) and a picture of the present invention (see Fig. 3 (b)), the pain when sitting in a hard place The patient is appealing. In the case of a patient who was treated by breaking the tailbone after falling only 3m from the patient, the patient was implanted with a passive catheter of the present invention, and the pulsed RF 600sec 55V, 5Hz / 5ms, 360Ω, 150mA After transmitting the pulsatile high frequency signal having the condition of “done” to the electrode implanted between the spine and the vertebrae, applying electric stimulation to the corresponding area for 30 minutes by using the pulsatile high frequency signal, the heat sensitivity of the back improves more than 30% and then The pain in the tailbone was improved by 100% and 40 ~ 50% after 5 days more pain after treatment using pulsatile radiofrequency signal. After one month of treatment using these pulsatile radiofrequency signals, the pain in the tailbone was 70% better than in the first place.
도 4는 양팔 전체가 빠질 듯 우리하고, 밤으로 쑤시는 통증을 호소하고, 통증으로 잠들기 힘들며, 왼팔 및 왼손에 힘이 떨어지고 살이 빠지고 손가락을 펴기 힘들며, 왼다리에 힘이 없어 절뚝거리며 걷는 루게릭병(근위축성 측색 경화증) 환자에게 본 발명인 수동형 카테타를 이식하고, 체외 박동성 고주파 자극장치를 통해 "Pulsed RF 600sec 55V, 5Hz/5ms, 182ohm, 304mA done" 조건을 가지는 박동성 고주파 신호를 이용하여 해당 부위에 전기적 자극을 주는 치료를 수행한 후 통증이 제거되어 편안한 상태로 되었고, 왼팔 통증의 경우 70%에서 85%로 호전되었으며, 0.5kg의 아령 운동이 가능하게 되었으며, Biceps 증가하고 더 이상 살 빠지지 않았으며, 왼쪽손으로 종이집기가 가능해졌으며, 걷는데도 어둔한 느낌 줄어들었으며, 한꺼번에 4~5km까지 걸을 수 있도록 호전되었다.Figure 4 shows that the whole arm is missing, we complain of pain at night, it is hard to fall asleep, pain in the left arm and left hand, lose weight, hard to stretch fingers, limp walking in limp because there is no strength in the left leg (Atrophic lateral sclerosis) The patient was implanted with a passive catheter of the present invention, and the pulsatile high frequency signal having the condition "Pulsed RF 600sec 55V, 5Hz / 5ms, 182ohm, 304mA done" through an in vitro pulsatile radiofrequency stimulator was applied to the site. After the electrical stimulation treatment, the pain was eliminated and relaxed, the left arm pain improved from 70% to 85%, 0.5kg of dumbbell exercise was possible, Biceps increased, and no longer lost weight. It is possible to grab paper with the left hand, reduce the dim feeling when walking, and improve to walk 4 ~ 5km at a time.
도 5 내지 도 7은 신경병증성 통증으로 지속적인 재활 치료를 위해 입원한 상태의 환자로서, 손발이 터쳐나가는 듯한 통증 및 등에 불이 나고 있는 정도의 뜨거운 느낌의 통증을 호소하는 환자에게 본 발명인 수동형 카테타를 이식하고, 체외 박동성 고주파 자극장치를 통해 1차 "Pulsed RF mode : 600sec, 55V, 5Hz/20ms, 42℃, 320Ω" 조건(도 5의 (a) 참조)을 가지는 박동성 고주파 신호를 이용하여 해당 부위에 전기적 자극을 주는 치료를 수행한 후 도 6의 (a)에 도시된 바와 같이 치료 후 손발 및 등 통증의 경우 시술 다음날 떨어졌으며, 그 이후 약간의 등락은 있으나 시술전보다 떨어진 것으로 나타났으며 도 7에 도시된 바와 같이 침대의 기울기와 휠체어의 등받이 각도를 변경시켜도 될 정도로 통증이 완화되었으며, 또한 2차 "Pulsed RF mode : 600sec, 55V, 5Hz/5ms, 37℃, 445Ω, 130mA" 조건(도 5의 (b) 참조)을 가지는 박동성 고주파 신호를 이영하여 해당 부위에 전기적 자극을 주는 치료를 수행한 후 도 6의 (b)에 도시된 바와 같이 치료 후 손발 및 등 통증이 더 떨어진 것으로 나타났다.5 to 7 is a patient who is hospitalized for continuous rehabilitation treatment with neuropathic pain, the passive catheter of the present invention to a patient complaining of pain such as popping of the hands and feet and the pain of hot feeling such as burning on the back Using a pulsatile high frequency signal having a primary "Pulsed RF mode: 600sec, 55V, 5Hz / 20ms, 42 ℃, 320Ω" condition (see Fig. 5 (a)) through an in vitro pulsatile high frequency stimulator After performing the treatment to give electrical stimulation to the site as shown in Fig. 6 (a), the hand and foot and back pain after treatment fell the day after the procedure, after which there was a slight fluctuation, but appeared to be lower than before the procedure. As shown in Fig. 7, the pain was relieved enough to change the inclination of the bed and the angle of the backrest of the wheelchair, and the second "Pulsed RF mode: 600sec, 55V, 5Hz / 5ms, 37 ℃, 445Ω, 1 After pulsating high frequency signal having a 30 mA "condition (see FIG. 5 (b)) to perform electrical stimulation treatment on the corresponding site, the limbs and back pain after treatment as shown in FIG. Appeared to fall further.
도 8은 지릿지릿하고 발바닥이 자갈을 밟는 듯한 통증을 호소하는 환자에게 본 발명인 수동형 카테타를 이식하고, 체외 박동성 고주파 자극장치를 통해 박동성 고주파 신호를 이용하여 해당 부위에 전기적 자극을 주는 치료를 수행하도록 하고, 이러한 치료 후 환자 양 발의 지릿지릿한 통증을 50% 감소시킬 수 있었으며, 두 발의 자갈 밟는 느낌은 있으나 이전보다 통증의 규모가 작아진 상태인 것으로 나타났다.8 is implanted in the passive catheter of the present invention to the patient complains of pain like crushing the soles of the feet and perform the treatment to give electrical stimulation to the corresponding site using the pulsatile radiofrequency signal through the in vitro pulsatile radiofrequency stimulator After this treatment, it was possible to reduce the gritty pain of the patients' feet by 50%, and there was a feeling of stepping on the gravel of the two feet, but the pain was smaller than before.
전술한 내용은 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자라면 본 발명의 본질적인 특성에서 벗어나지 않는 범위에서 수정 및 변형이 가능할 것이다. 따라서, 본 발명에 개시된 실시예들은 본 발명의 기술 사상을 한정하기 위한 것이 아니라 설명하기 위한 것이고, 이러한 실시예에 의하여 본 발명의 기술 사상의 범위가 한정되는 것은 아니다. 본 발명의 보호 범위는 아래의 청구범위에 의하여 해석되어야 하며, 그와 동등한 범위 내에 있는 모든 기술 사상은 본 발명의 권리범위에 포함되는 것으로 해석되어야 할 것이다.The foregoing description will be apparent to those skilled in the art that modifications and variations may be made without departing from the essential features of the present invention. Therefore, the embodiments disclosed in the present invention are not intended to limit the technical idea of the present invention but to describe the present invention, and the scope of the technical idea of the present invention is not limited by these embodiments. The protection scope of the present invention should be interpreted by the following claims, and all technical ideas within the equivalent scope should be interpreted as being included in the scope of the present invention.

Claims (8)

  1. 환자상태에 따라 박동성고주파 신호를 선정할 수 있도록 하고, 선정된 박동성고주파 신호 정보를 치료용 박동성고주파 신호로 변환시킨 후 무선형태로 변환시켜 안테나를 통해 송출하는 치료용 박동성 고주파신호 발생장치; 및 A therapeutic pulsatile high frequency signal generating device capable of selecting a pulsatile high frequency signal according to a patient's condition, converting the selected pulsatile high frequency signal information into a therapeutic pulsatile high frequency signal and converting the radio frequency into a wireless form; And
    체내에 이식된 안테나를 통해 치료용 박동성 고주파신호를 수신받아 해당 부위에 전기적 자극이 발생되도록 하는 수동형 생체이식형 카테타;A passive biograft catheter receiving a therapeutic pulsatile high frequency signal through an antenna implanted in the body to generate electrical stimulation at a corresponding site;
    를 포함하는 수동형 카테타용 체외 박동성 고주파 자극장치.In vitro pulsatile high frequency stimulation device for a passive catheter comprising a.
  2. 제 1 항에 있어서,The method of claim 1,
    상기 치료용 박동성고주파신호 발생장치가, The therapeutic pulsatile high frequency signal generator,
    통증치료에 필요한 주파수를 선정할 수 있도록 서비스하고, 외부로부터 가해지는 물리적인 힘에 의해 선정된 주파수 정보를 기반으로 치료용 박동성 고주파신호 발생요청신호를 생성시켜 출력하는 입력부와, An input unit for selecting a frequency required for pain treatment and generating and outputting a therapeutic pulsatile high frequency signal generation request signal based on frequency information selected by a physical force applied from the outside;
    입력부로부터 치료용 박동성 고주파신호 발생요청신호가 입력되면 치료용 초기 신호를 발생시켜 출력하는 한편 박동성 고주파신호 발생부가 박동성 고주파신호를 발생시키도록 제어하는 제어부와, A control unit for generating and outputting an initial signal for treatment when the therapeutic pulsatile high frequency signal generation request signal is input from the input unit, and controlling the pulsatile high frequency signal generator to generate a pulsatile high frequency signal;
    상기 제어부의 제어에 응하여 미리 설정된 박동성고주파신호를 발생시켜 출력하는 박동성고주파신호 발생부와, A pulsatile high frequency signal generator for generating and outputting a preset pulsatile high frequency signal according to the control of the controller;
    상기 제어부로부터 치료용 초기신호를 입력받고, 상기 박동성 고주파신호 발생부로부터 박동성고주파신호 정보를 입력받아 혼합시켜 치료용 전기적 신호로 변환시키고, 치료용 전기적 신호를 출력하는 박동성 고주파 게이트웨이와, A pulsatile high frequency gateway which receives a treatment initial signal from the controller, receives pulsatile high frequency signal information from the pulsatile high frequency signal generator, converts the pulsatile high frequency signal into a therapeutic electrical signal, and outputs a therapeutic electrical signal;
    상기 박동성 고주파 게이트웨이로부터 치료용 전기적 신호를 입력받아 증폭시키는 박동성고주파 전력증폭부와, A pulsatile high frequency power amplifier for receiving and amplifying a therapeutic electrical signal from the pulsatile high frequency gateway;
    상기 증폭된 치료용 전기적 신호를 무선형태의 치료용 박동성고주파신호로 변환시켜 안테나를 통해 송출하는 무선전력 제어부로 이루어진 것을 특징으로 하는 수동형 카테타용 체외 박동성 고주파 자극장치.An extracorporeal pulsatile high frequency stimulation apparatus for a passive catheter, characterized in that the wireless power control unit converts the amplified therapeutic electrical signal into a radio frequency therapeutic pulsatile high frequency signal and transmits the same through an antenna.
  3. 제 1 항에 있어서,The method of claim 1,
    2개의 수동형 생체이식형 카테타를 체내에 삽입하여 원하는 척수 신경구간을 자극하기 위해 2개의 수동형 생체이식형 카테타의 자극 동기화를 위하여 2개의 치료용 박동성 고주파신호 발생장치를 동기화 모드로 서비스하는 것을 특징으로 하는 수동형 카테타용 체외 박동성 고주파 자극장치. In order to stimulate the desired spinal cord nerve segment by inserting two passive biograft catheters into the body, two therapeutic pulsatile high frequency signal generators are serviced in synchronization mode for synchronous synchronization of two passive biograft catheters. Extracorporeal pulsatile high frequency stimulation device for passive catheter.
  4. 제 2 항에 있어서, The method of claim 2,
    입력부가 통증 치료나 신경 이상의 조절 치료에 필요한 주파수를 선정 시, 주파수의 듀레이션(duration) 및 치료시간을 선정할 수 있도록 서비스하는 것을 특징으로 하는 수동형 카테타용 체외 박동성 고주파 자극장치.When the input unit selects a frequency required for pain treatment or neuromodulation control treatment, the extracorporeal pulsatile high frequency stimulation device for passive catheter, characterized in that the service to select the duration (duration) and treatment time.
  5. 제 2 항에 있어서,The method of claim 2,
    상기 제어부가, 상기 입력부를 통해 복수의 환자상태정보를 제공하고, 상기 환자상태정보 중 하나의 환자상태정보가 선택되면 해당 치료용 주파수, 듀레이션, 치료시간을 선정할 수 있도록 서비스하는 인터페이스 화면이 제공되도록 하는 수동형 카테타용 체외 박동성 고주파 자극장치.The controller provides a plurality of patient state information through the input unit, and if one of the patient state information is selected, an interface screen for providing a service frequency, duration, and treatment time may be selected. Extracorporeal pulsatile high frequency stimulator for passive catheter.
  6. 제 1 항에 있어서,The method of claim 1,
    상기 치료용 박동성 고주파신호 발생장치가, The therapeutic pulsatile high frequency signal generator,
    복수의 환자상태정보 및 복수의 환자상태정보에 듀레이션 및 치료시간정보들을 링크시켜 저장하고 있는 저장부를 더 포함하고 있으며, It further comprises a storage unit for storing the duration and treatment time information linked to the plurality of patient status information and a plurality of patient status information,
    상기 제어부가, 상기 저장부에 저장된 정보들을 읽어들여 입력부를 통해 제공되도록 하는 것을 특징으로 하는 수동형 카테타용 체외 박동성 고주파 자극장치.And the control unit reads the information stored in the storage unit to be provided through the input unit.
  7. 제 2 항에 있어서,The method of claim 2,
    상기 입력부가 터치스크린 형태로 제공되는 것을 특징으로 하는 수동형 카테타용 체외 박동성 고주파 자극장치.In vitro pulsatile high frequency stimulation device for a passive catheter, characterized in that the input unit is provided in the form of a touch screen.
  8. 제 2 항에 있어서,The method of claim 2,
    상기 무선전력 제어부가, 전극에 연결된 안테나와의 고주파 정합이 이루어지도록 하고, 안테나를 통해 송출되는 치료용 박동성고주파 신호의 출력상태를 모니터링하는 것을 특징으로 하는 수동형 카테타용 체외 박동성 고주파 자극장치.Wherein the wireless power control unit, to ensure high frequency matching with the antenna connected to the electrode, the extracorporeal pulsatile high frequency stimulation apparatus for passive catheter, characterized in that for monitoring the output state of the pulsatile high frequency signal transmitted through the antenna.
PCT/KR2015/001112 2014-12-31 2015-02-03 Passive bio-implanted pulsatile high-frequency stimulator for catheter for stimulating transsacral epidural spinal nerve WO2016108331A1 (en)

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