CN105615998A - Atherosclerosis targeted therapy device - Google Patents
Atherosclerosis targeted therapy device Download PDFInfo
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- CN105615998A CN105615998A CN201610112668.4A CN201610112668A CN105615998A CN 105615998 A CN105615998 A CN 105615998A CN 201610112668 A CN201610112668 A CN 201610112668A CN 105615998 A CN105615998 A CN 105615998A
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- 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
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- 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
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- A61B2018/00404—Blood vessels other than those in or around the heart
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Abstract
本发明提供了一种动脉粥样硬化靶向治疗装置，包括至少一个治疗球囊和治疗控制系统，治疗球囊的外表面设置有多个可独立工作的射频微电极阵列与温度传感器，治疗球囊的内部设置有用于容纳和循环冷介质的冷介质循环通路，治疗控制系统通过控制冷介质循环控制模块以调节冷介质循环通路中的冷介质的流速，以调节温度，并通过射频治疗控制模块控制每一个射频输出端口的输出信号，其输出信号可以相同也可以不同，以使射频微电极可以处于不同的开关状态及不同的射频频率。本发明操作简便，复杂度低，能够对动脉粥样硬化斑块进行无创或微创的靶向治疗。
The present invention provides an atherosclerosis targeted treatment device, which includes at least one treatment balloon and a treatment control system. The outer surface of the treatment balloon is provided with a plurality of radio frequency microelectrode arrays and temperature sensors that can work independently. The interior of the bag is provided with a cold medium circulation channel for containing and circulating the cold medium, and the treatment control system adjusts the flow rate of the cold medium in the cold medium circulation channel by controlling the cold medium circulation control module to adjust the temperature, and through the radio frequency treatment control module The output signals of each radio frequency output port are controlled, and the output signals can be the same or different, so that the radio frequency microelectrodes can be in different switching states and different radio frequency frequencies. The invention has simple operation and low complexity, and can perform non-invasive or minimally invasive targeted therapy on atherosclerotic plaque.
Description
Technical field
The present invention relates to biomedical engineering field, be specifically related to a kind of atherosclerosis guiding target treatment device.
Background technology
Atherosclerosis (Atherosclerosis) hazardness is big, and sickness rate is high, medical science and biology etc. field be all the emphasis of research all the time. Atherosclerosis can cause that the attenuating of arterial elasticity and arterial lumen narrow, and then causes local organization ischemia, myocardial infarction, apoplexy, angina pectoris etc. Atherosclerosis mainly originates from the propagation of endarterium lipidosis and smooth muscle cell, finally causes inner membrance fibrous thickening, and forms atheromatous plaque.
But, in current topmost Therapeutic Method, blood vessel is reinvented by angioplasty, expand vessel lumen, postoperative easy generation vascular restenosis, and adopt ablation to kill rapidly the smooth muscle cell causing angiostenosis, and can cause that endovascular biological tissue environment is seriously damaged, postoperative restenosis incidence rate is significantly high. Owing to the endotheliocyte of blood vessel wall inner membrance has important regulatory function, it is possible to regulated the propagation of the smooth muscle cell of tunica media by the release cells factor; Vascular endothelial cell, due to mechanical presses, to blood vessel heating or freezing, all can be caused damage in various degree by traditional method. It it is one of main reason causing vessel lumen restenosis.
Existing radio frequency and freezing model are used widely in the treatment of clinical each big disease. As Cai et al. utilizes radio frequency penetration effect heating tumor, the tumor at epidermis position is regarded the spheroidal structure that radius is only small, sets up electric field with this and models for temperature field studies its Temperature Distribution; The tumor at different radii different tissues position is considered as the constant bulk of heat conductivity or annular tissue research heat transfer by S.Halal et al.; And WilliamG and D.E.Fleischer et al. utilizes radio frequency to pass through sacculus to have carried out the treatment of the disease such as ventricular tachycardia and Ba Leiteshi esophagus respectively, and this radio frequency sacculus is not suitable for atherosclerotic blood vessel internal therapentics targetedly; Anderson et al. has considered the factors such as blood vessel, a new scheme is given for neoplastic fevers naturopathy, but its scheme model is still based upon on the basis of large-scale lumps tumor, it does not have consider that the parameters such as heat conductivity can be affected by temperature. In the past ermal physics mode is mainly used in deep tissue as can be seen here, treats as utilized radio frequency etc. that the penetration effect of deep tissue is heated tumor mass.
Swash the essential therapeutic arsenals that optical and radio fequency sacculus is the treatment of current atheromatosis ermal physics. Geschwind, Ginsburg, Choy and Cumberland etc. apply the speckle in laser probe ablation vessels respectively clinically, get through the blood vessel of obturation. Decker and Christensen etc. establish the conducting heat model of LASER HEATING blood vessel, and compare with experimental data.
Except LASER HEATING blood vessel, Becker etc. are that after solving the vasodilation art treatment vascular lesion position of common sacculus, the middle film of caused blood vessel and inner membrance can peel off problem mutually, fit whole piece radio-frequency electrode in Common radio frequency balloon surface, utilize radio-frequency energy heats blood vessel wall, and then vascular lesion position is treated, this Therapeutic Method employs whole balloon surface and is heated ablation as radio-frequency electrode, thus being extremely difficult to carry out conformal targeted therapy for different size focus. Fram etc. consider that radio-frequency electrode is placed on balloon surface and not easily passs through percutaneous surgery sacculus is carried lesion locations, and the catheter shaft in sacculus arranges radio-frequency electrode, and correspondingly arrange one group of thermocouple near radio-frequency electrode for measuring temperature in sacculus, and in radio frequency sacculus, fill normal saline, by the mode of conduction of heat, increase the heat being delivered to blood vessel wall, this mode have employed normal saline and makes the balloon surface of fixed dimension be in thermally equivalent, but all influence areas that same heating region is surrounding electric poles, the conformal therapy to different size speckle cannot be accomplished.
In sum, this area is in the urgent need to having the atherosclerosis guiding target treatment device of better healing effect
Summary of the invention
The purpose that the present invention carries just is to provide a kind of atherosclerosis guiding target treatment device, and atherosclerosis has better curative effect.
In the first aspect of the invention, it is provided that a kind of atherosclerosis guiding target treatment device, including at least one treatment sacculus and treatment control system, wherein
The outer surface for the treatment of sacculus is provided with multiple radio frequency microelectrode array that can work independently and temperature sensor, treats the cold medium circulation path being internally provided with for holding and circulate cold medium of sacculus, and
Treatment control system comprises cold medium circulation and controls module and radio-frequency (RF) therapy control module, cold medium circulation controls module and is connected to cold medium circulation path by control output end mouth, radio-frequency (RF) therapy controls module and comprises radio frequency selection circuit and radio frequency output port, and radio-frequency (RF) therapy controls the treatment radio frequency microelectrode that module selects to connect on radio frequency output port by radio frequency selection circuit; And
Treatment control system controls the flow velocity of the cold medium in cold medium circulation path for controlling module by cold medium circulation, to regulate temperature, and the output signal of each radio frequency output port is controlled by radio-frequency (RF) therapy control module, its output signal can be the same or different, so that radio frequency microelectrode may be at different on off states and different rf frequencies.
In another preference, output signal refers to that the switch controlling signal of radio frequency microelectrode and rf frequency select control signal.
In another preference, treatment control system also comprises main control module, main control module comprises touch screen and is connected to the microcontroller of this touch screen, the main control module size according to atheromatous plaque, shape selects corresponding radio frequency microelectrode that it is carried out conformal targeted therapy, the power of feedback treating simultaneously, treatment energy and real-time treatment temperature, treatment power according to feedback, energy, temperature controls corresponding radio-frequency (RF) therapy and controls module output radiofrequency signal and control the work of respective radio-frequency microelectrode and control the work of cold medium circulation module, thus reaching the treatment to atherosclerotic plaque and the protective effect to blood vessel endothelium.
In another preference, treatment control system also comprises the radio-frequency (RF) therapy being connected with main control module and controls module, for according to the control signal from main control module, control the on off state of radio frequency microelectrode by radio frequency output port and select the rf frequency for the treatment of, radio-frequency (RF) therapy controls module and includes radio frequency frequency selection circuit, radio-frequency power supply circuit for generating, radio frequency controls output circuit and radio frequency output interface.
In another preference, each radio frequency output port respectively with each radio frequency microelectrode one to one or one-to-many or many-one be connected.
In another preference, treatment control system also comprises Feedback of Power circuit and cold medium circulation control circuit, wherein,
Feedback of Power circuit respectively with radio frequency output port, and microcontroller connects, for the power parameter of each radio frequency microelectrode gathered to microcontroller feedback from radio frequency output port and energy parameter;
Cold medium circulation control circuit is connected with microcontroller and cold medium circulation path respectively, for according to microcontroller from the power parameter of radio frequency microelectrode, energy parameter, the determined control signal of real time temperature, flow velocity by the cold medium in SAPMAC method medium control port controlling cold medium circulation path, to regulate temperature, wherein cold medium can be external by being back to, or is flowed in blood vessel by the another port of sacculus.
In another preference, radio frequency microelectrode is burnt at the surface for the treatment of sacculus with the form of multiple electrod-arrays.
In another preference, the temperature range of cold medium is-20 DEG C-37 DEG C.
In another preference, the area of each radio frequency microelectrode is identical, or different, and areal extent is 0.01mm2To 1000mm2��
In another preference, the operating frequency range of radio frequency microelectrode is optional between 200KHz-200MHz.
In another preference, main control module adopts the microprocessor of 32 bit DSPs.
In another preference, comprising at least one treatment sacculus, each radio frequency output port is connected one to one with each radio frequency microelectrode respectively.
In another preference, radio frequency microelectrode is burnt at balloon surface by specific process technology and draws with supravasal microelectrode lead, then passes through flexible cable access control system, forms treatment control access.
In another preference; main control module can select corresponding radio frequency microelectrode that it is carried out conformal targeted therapy according to the size of atheromatous plaque, shape; the power of feedback treating and treatment energy simultaneously; treatment power radio-frequency (RF) therapy corresponding with energy hole according to feedback controls module output radiofrequency signal and controls the work of respective radio-frequency microelectrode and control cold medium circulation module and work, thus protective effect to blood vessel endothelium while reaching the treatment to atherosclerotic plaque.
In another preference; balloon surface distribution have the radio frequency microelectrode array of multiple particular size specification; for according to the corresponding plaque of conformal therapy; and small temperature sensor; for the temperature information in Real-time Collection therapeutic process; further, balloon interior may be equipped with cold medium circulation path for protecting vascular endothelial tissue, and the radio frequency microelectrode size of described particular size specification is at 0.01mm2-1000mm2Between not etc.; The temperature of cold medium here associated media between-20 DEG C-37 DEG C.
In another preference, can be independent from during the work of balloon surface radio frequency microelectrode, and the end of foley's tube it is drawn out to by being burnt at the wire on balloon surface and foley's tube surface, then use flexible cable to access radio frequency circuit for generating by Aviation Connector.
In another preference, system can select the combination of corresponding conformal radio frequency microelectrode according to the size of vascular plaque, size, shape, to reach targeted therapy purpose.
In another preference, control module with radio frequency frequency selection circuit, it is possible to according to the treatment corresponding radio-frequency (RF) therapy frequency of actual selection, to reach the penetration depth requirement to the treatment of different depth speckle; Here the selectable radio-frequency (RF) therapy frequency of radio frequency selection circuit is the frequency between 200KHz-200MHz.
In another preference, the governor circuit of device have employed the microprocessor of 32 bit DSPs as master controller, and whole apparatus system carries out programmed therapy control and the realization for the treatment of algorithm.
In another preference, described device adopts touch screen to carry out system control and visualization display, on screen, selecting to open corresponding therapeutic electrode during treatment treat, thus reaching targeted therapy targetedly, and showing the corresponding treatment parameter in therapeutic process in real time.
In another preference; the device of the atherosclerosis targeted therapy of the present invention and system; described therapy equipment includes master control system and targeted therapy sacculus; described treatment balloon surface distribution has radio frequency microelectrode and the temperature sensor of multiple application treatment of atherosclerosis, and blood vessel endothelium carries out during for treating the cold medium circulation path of real-time guard. Described master control system includes microprocessor control circuit, touch display circuit, radio frequency circuit for generating, electrode selecting circuit, cold medium circulation control circuit; Described control system, according to information such as the size of actual atheromatous plaque to be treated, size, the degree of depth, selects radio frequency microelectrode conformal accordingly, thus controlling electrode selecting circuit, opens the radio frequency microelectrode that sacculus is corresponding; Open accordingly over the course for the treatment of, to regulate cold medium circulation system injury-free over the course for the treatment of with real-time guard blood vessel endothelium simultaneously; And Real-time Feedback treats the relevant parameter of power and treatment energy over the course for the treatment of, the then system work process according to the relevant parameter controlled system with self-regulation in therapeutic process, to realize atherosclerotic targeted therapy.
In another preference, the determination of the information such as the size of the atheromatous plaque in described therapeutic process, size, the degree of depth, have employed the Angiography technology of advanced person, small blood vessel imaging probe is goed deep into internal blood vessel, carries out real-time internal blood vessel imaging and navigation.
In another preference, described therapy equipment also includes radio-frequency power supply and radio frequency generation module, its therapeutic process regulates the power of radio frequency source mainly by Programmed control to reach melting and the purpose for the treatment of corresponding atheromatous plaque.
In another preference, in the design of described radio frequency circuit for generating, employ the radio frequency matching network circuit of multi-frequency, to reach to adapt to the requirement of the atheromatous plaque treatment of different size, size and the degree of depth.
In another preference; described therapy equipment further comprises cold medium circulation system; described cold medium circulation system; by main control circuit according to corresponding treatment parameter in therapeutic process; control cold medium circulation control circuit; thus the cold velocity of medium controlled in cold medium circulation system, to reach the cooling to treatment blood vessel endothelium, thus playing the protective effect to treatment blood vessel endothelium.
In another preference, described therapy equipment have employed resistance type touch control screen carry out system control arrange with visualization man-machine interaction show. Described resistance type touch control screen is mainly used in arranging treatment parameter over the course for the treatment of, lower transmission control parameter and corresponding control command information, and the information such as associated treatment parameter in display therapeutic process in real time; Described touch screen carries out system control, and it adopts having the advantage that of touch screens to be operated over the course for the treatment of easily controlling.
In another preference, treatment sacculus in described treatment system, before treatment sacculus is goed deep into internal blood vessel, then use internally saline injection or other associated medias to enable to sacculus to expand, thus propping up blood vessel to be treated, the treatment microelectrode making balloon surface is fully contacted with speckle to be treated, thus reaching the purpose of targeted therapy; And balloon interior is with cold medium circulation passage, it is used for the cooling down to blood vessel endothelium while radio frequency heating is treated, to protect vascular endothelial tissue injury-free.
In another preference, described electrode control circuit, mainly microprocessor sends corresponding control signal according to specific treatment algorithm, then controls the conformal radio frequency microelectrode of correspondence, thus realizing the selectively unlocking to sacculus radio frequency microelectrode, to reach the purpose of conformal targeted therapy.
In another preference, described radio frequency sacculus microelectrode have employed specific micro-fluidic process technology, by the electrode of specific dimensions according to certain specification arranged in balloon surface, then pass through after the electrode cable on the wire of balloon surface and foley's tube is drawn and access radio-frequency power supply interface by flexible cable, it is achieved treatment path.
The beneficial effects of the present invention is: complexity is low, easy and simple to handle, efficiency is high, it is possible to realize the practical situation according to atheromatous plaque, carry out the targeted therapy of correspondence.
Should be understood that within the scope of the present invention, above-mentioned each technical characteristic of the present invention and can combining mutually between specifically described each technical characteristic in below (eg embodiment), thus constituting new or preferred technical scheme. As space is limited, tired no longer one by one state at this.
Accompanying drawing explanation
Fig. 1 is the attachment structure figure of atherosclerosis guiding target treatment device of the present invention;
Fig. 2 is the balloon structure schematic diagram of the preferred embodiment of the present invention;
Fig. 3 is that the Temperature Distribution that microelectrode heating produces at expandable prosthetic changes over trendgram;
Fig. 4 is that different radio frequency number of electrodes affects schematic diagram to what organize heating efficiency;
Fig. 5 is the different radio frequency number of electrodes 3D temperature profile to tissue heating;
Fig. 6 is that in sacculus, radio frequency sacculus heating efficiency is affected schematic diagram by different temperatures cooling water;
Fig. 7 is that in sacculus, different temperatures cools down the 3D scattergram of sacculus heating-up temperature under water effect.
In the drawings, A: treatment control system, B: power supply, C: cold medium circulation system, D: flexible cable, E: sacculus, A1: microcontroller, A2: touch control display module, A3: rf frequency selection circuit, A4: radio frequency circuit for generating, A5: electrode switch selection circuit, A6: power/energy feedback circuit, A7: radio frequency interface, A8: cold medium circulation control circuit, E1: radio frequency microelectrode, E2: foley's tube, E3: sacculus.
Detailed description of the invention
The present inventor is through extensive and deep research, take into full account that radio frequency sacculus treatment temperature and the pass for the treatment of time are fastened, have employed the model of ermal physics treatment, consider the relation of radio-frequency electromagnetic transmission in the tissue and temperature, probe into the Temperature Distribution of blood vessel wall at different radio frequency field and balloon surface temperature, and take full advantage of the different frequency radiofrequency signal penetration capacity to tissue, devise a kind of atherosclerosis guiding target treatment device and for different size, sized arteries atherosclerotic plaque carries out the treatment sacculus of conformal therapy, effectively atheromatous plaque is carried out targeted therapy.
Term
As used herein, term " microprocessor ", " microcontroller " are used interchangeably.
As used herein, term " radio frequency microelectrode switch selection circuit ", " electrode switch selection circuit " are used interchangeably.
As used herein, term " sacculus ", " treatment sacculus " are used interchangeably.
As used herein, term " cold medium circulation control circuit ", " SAPMAC method control module " are used interchangeably.
As used herein, term " touch screen ", " touch control display module " are used interchangeably.
As used herein, term " main control module ", " master controller " are used interchangeably.
As used herein, term " radio frequency interface ", " radio frequency output port " are used interchangeably.
Always being broadly described of device
In the first aspect of the invention, it is provided that a kind of atherosclerosis guiding target treatment device, including at least one treatment sacculus and treatment control system, wherein
The outer surface for the treatment of sacculus is provided with multiple radio frequency microelectrode array that can work independently and temperature sensor, treats the cold medium circulation path being internally provided with for holding and circulate cold medium of sacculus, and
Treatment control system comprises cold medium circulation and controls module and radio-frequency (RF) therapy control module, cold medium circulation controls module and is connected to cold medium circulation path by control output end mouth, radio-frequency (RF) therapy controls module and comprises radio frequency selection circuit and radio frequency output port, and radio-frequency (RF) therapy controls the radio frequency microelectrode that module selects to connect on radio frequency output port by radio frequency selection circuit; And
Treatment control system controls the flow velocity of the cold medium in cold medium circulation path for controlling module by cold medium circulation, to regulate temperature, and the output signal of each radio frequency output port is controlled by radio-frequency (RF) therapy control module, its output signal can be the same or different, so that radio frequency microelectrode may be at different on off states and different rf frequencies.
In another preference, output signal refers to that the switch controlling signal of radio frequency microelectrode and rf frequency select control signal.
In another preference, treatment control system also comprises main control module, main control module comprises touch screen and is connected to the microcontroller of this touch screen, the main control module size according to atheromatous plaque, shape selects corresponding radio frequency microelectrode that it is carried out conformal targeted therapy, the power of feedback treating and treatment energy simultaneously, and the real time temperature in collection therapeutic process, real time temperature according to feedback, treatment power radio-frequency (RF) therapy corresponding with energy hole controls module output radiofrequency signal and controls the work of respective radio-frequency microelectrode and control the work of cold medium circulation module, thus reaching the treatment to atherosclerotic plaque and the protective effect to blood vessel endothelium.
In another preference, treatment control system also comprises the radio-frequency (RF) therapy being connected with main control module and controls module, for according to the control signal from main control module, control the on off state of radio frequency microelectrode by radio frequency output port and select the rf frequency for the treatment of, radio-frequency (RF) therapy controls module and includes radio frequency frequency selection circuit, radio-frequency power supply circuit for generating, radio frequency controls output circuit and radio frequency output interface.
In another preference, each radio frequency output port respectively with each radio frequency microelectrode one to one or one-to-many or many-one be connected.
In another preference, treatment control system also comprises Feedback of Power circuit, and cold medium circulation control circuit, wherein, Feedback of Power circuit respectively with radio frequency output port, and microcontroller connects, for the power parameter to microcontroller feedback from each radio frequency microelectrode of radio frequency output port collection and energy parameter;
Cold medium circulation control circuit is connected with microcontroller and cold medium circulation path respectively, for according to microcontroller from the power parameter of radio frequency microelectrode and the determined control signal of energy parameter, by the flow velocity of the cold medium in SAPMAC method medium control port controlling cold medium circulation path, to regulate temperature.
In another preference, radio frequency microelectrode is evenly provided on the surface for the treatment of sacculus.
In another preference, radio frequency balloon surface is also distributed temperature sensor.
In another preference, the temperature range of cold medium is-20 DEG C-37 DEG C.
In another preference, the area of each radio frequency microelectrode is identical, or different, and areal extent is 0.01mm2To 1000mm2��
In another preference, the operating frequency range of radio frequency microelectrode is optional between 200KHz-200MHz.
In another preference, main control module adopts the microprocessor of 32 bit DSPs.
In another preference, comprising three treatment sacculus, each radio frequency output port is connected one to one with each radio frequency microelectrode respectively.
In another preference, radio frequency microelectrode is burnt at balloon surface by specific process technology and draws with supravasal microelectrode lead, then passes through flexible cable access control system, forms treatment control access.
In another preference; main control module can select corresponding radio frequency microelectrode that it is carried out conformal targeted therapy according to the size of atheromatous plaque, shape; the power of feedback treating and treatment energy simultaneously; treatment power radio-frequency (RF) therapy corresponding with energy hole according to feedback controls module output radiofrequency signal and controls the work of respective radio-frequency microelectrode and control the work of cold medium circulation module, thus reaching the treatment to atherosclerotic plaque and the protective effect to blood vessel endothelium.
In another preference; balloon surface distribution have the radio frequency microelectrode array of multiple particular size specification; for according to the corresponding plaque of conformal therapy; and; balloon interior may be equipped with cold medium circulation path for protecting vascular endothelial tissue, the radio frequency microelectrode size of particular size specification at 0.01mm2-1000mm2Between not etc.; The temperature of cold medium here associated media between-20 DEG C-37 DEG C.
In another preference, can be independent from during the work of balloon surface radio frequency microelectrode, and the end of foley's tube it is drawn out to by being burnt at the wire on balloon surface and foley's tube surface, then use flexible cable to access radio frequency circuit for generating by Aviation Connector.
In another preference, system can select to be conformal radio frequency microelectrode accordingly according to the size of vascular plaque, size, shape, to reach targeted therapy purpose.
In another preference, control module with radio frequency frequency selection circuit, it is possible to according to the treatment corresponding radio-frequency (RF) therapy frequency of actual selection, to reach the penetration depth requirement to the treatment of different depth speckle; Here the selectable radio-frequency (RF) therapy frequency of radio frequency selection circuit is the frequency between 200KHz-200MHz.
In another preference, the governor circuit of device have employed the microprocessor of 32 bit DSPs as master controller, and whole apparatus system carries out programmed therapy control and the realization for the treatment of algorithm.
In another preference, device adopt touch screen carry out system control with visualization display, on screen, selecting to open corresponding therapeutic electrode during treatment treat, thus reaching targeted therapy targetedly, and showing the corresponding treatment parameter in therapeutic process in real time.
A kind of device for atherosclerosis targeted therapy of offer and system are provided; described therapy equipment includes master control system and targeted therapy sacculus; described treatment balloon surface is uniformly distributed the atherosclerotic conformal radio frequency microelectrode of application and temperature sensor, and blood vessel endothelium carries out during for treating the SAPMAC method path of real-time guard. Described master control system includes microprocessor control circuit, touch display circuit, radio frequency circuit for generating, electrode selecting circuit, SAPMAC method control circuit; Described control system, according to information such as the size of actual atheromatous plaque to be treated, size, the degree of depth, selects corresponding conformal radio frequency microelectrode, thus controlling electrode selecting circuit, opens the radio frequency microelectrode that sacculus is corresponding; Open accordingly over the course for the treatment of, to regulate SAPMAC method system injury-free over the course for the treatment of with real-time guard blood vessel endothelium simultaneously; And Real-time Feedback treats the relevant parameter of power and treatment energy over the course for the treatment of, the then system work process according to the relevant parameter regulation and control system in therapeutic process, to realize atherosclerotic targeted therapy.
Preferably, the determination of the information such as the size of the atheromatous plaque in described therapeutic process, size, the degree of depth, have employed the Angiography technology of advanced person, small blood vessel imaging probe is goed deep into internal blood vessel, carries out real-time internal blood vessel imaging and navigation.
Further, described therapy equipment also includes radio-frequency power supply and radio frequency generation module, its therapeutic process regulates the power of radio frequency source mainly by Programmed control to reach melting and the purpose for the treatment of corresponding atheromatous plaque.
Further, in the design of described radio frequency circuit for generating, employ the radio frequency matching network circuit of multi-frequency, to reach to adapt to the requirement of the atheromatous plaque treatment of different size, size and the degree of depth.
Further; described therapy equipment further comprises cold medium circulation system; described cold medium circulation system; by main control circuit according to corresponding treatment parameter in therapeutic process; control SAPMAC method control circuit; thus the cold velocity of medium controlled in cooling cycle system, to reach the cooling to treatment blood vessel endothelium, thus playing the protective effect to treatment blood vessel endothelium.
Further, described therapy equipment have employed resistance type touch control screen carry out system control arrange with visualization man-machine interaction show. Described resistance type touch control screen is mainly used in arranging treatment parameter over the course for the treatment of, lower transmission control parameter and corresponding control command information, and the information such as associated treatment parameter in display therapeutic process in real time; Described touch screen carries out system control, and it adopts having the advantage that of touch screens to be operated over the course for the treatment of easily controlling.
Further, treatment sacculus in described treatment system, before treatment sacculus is goed deep into internal blood vessel, then use internally saline injection or particular medium to enable to sacculus to expand, thus propping up blood vessel to be treated, the treatment microelectrode making balloon surface is fully contacted with speckle to be treated, thus reaching the purpose of targeted therapy; And balloon interior is with cold medium circulation passage, it is used for the cooling down to blood vessel endothelium while radio frequency heating is treated, to protect vascular endothelial tissue injury-free.
Further, described electrode control circuit, mainly microprocessor sends corresponding control signal according to specific treatment algorithm, then controls the conformal radio frequency microelectrode of correspondence, thus realizing the selectively unlocking to sacculus radio frequency microelectrode, to reach the purpose of conformal targeted therapy.
Further, described radio frequency sacculus microelectrode have employed specific micro-fluidic process technology, by the electrode of specific dimensions according to certain specification arranged in balloon surface, then pass through after the electrode cable on the wire of balloon surface and foley's tube is drawn and access radio-frequency power supply interface by flexible cable, it is achieved treatment path.
The major advantage of the present invention includes:
1) easy and simple to handle;
2) complexity designed is low;
3) different size atherosclerosis plate can be carried out significantly more efficient conformal targeted therapy.
4) protection to endothelial tissue while treatment of atherosclerosis can be realized.
Below in conjunction with specific embodiment, the present invention is expanded on further. Should be understood that these embodiments are merely to illustrate the present invention rather than restriction the scope of the present invention. The experimental technique of unreceipted actual conditions in the following example, generally conventionally condition or according to manufacturer it is proposed that condition. Unless otherwise indicated, otherwise percentage ratio and number are percentage by weight and parts by weight.
Embodiment 1: atherosclerosis guiding target treatment device No.1
The connection figure of the present embodiment atherosclerosis guiding target treatment device refers to Fig. 1, described device controls the system concrete condition according to atheromatous plaque mainly by atherosclerosis targeted therapy, control the radiofrequency signal of corresponding frequencies and the conformal radio frequency microelectrode opened on sacculus, thus reaching the therapeutical effect to atheromatous plaque.
Structure
Shown in accompanying drawing 1, described device includes treatment control system A, power supply B, cold medium circulation system C, flexible cable D, balloon-system E, wherein, treatment control system is made up of microcontroller A1, touch control display module A2, rf frequency selection circuit A3, radio frequency circuit for generating A4, electrode switch selection circuit A5, power/energy feedback circuit A6, radio frequency interface A7, cold medium circulation control circuit A8 etc.
Wherein, rf frequency selection circuit A3, radio frequency circuit for generating A4, electrode switch selection circuit A5 constitute above-mentioned radio-frequency (RF) therapy and control module. Microcontroller A1, touch control display module A2 constitute above-mentioned main control module.
As shown in Figure 2, according to specific standard, sacculus E3 requires that distribution has treatment radio frequency microelectrode E1, described radio frequency microelectrode E1 is burnt at balloon surface by specific process technology to draw with supravasal microelectrode lead, then pass through flexible cable D and access treatment control system A, form treatment control access.
As shown in Figure 1, the treatment control system A of the atherosclerosis guiding target treatment device of the present embodiment is mainly used for the power controlling radio frequency and energy and the corresponding conformal radio frequency microelectrode of selection, and control cold medium circulation system, thus reach the targeted therapy to atheromatous plaque.
Operation principle
In the work process of the atherosclerosis guiding target treatment device of the present embodiment, shape according to corresponding speckle, volume, size, corresponding conformal radio frequency microelectrode E3 is selected by touch screen A2, and (frequency of selection is according to concrete Therapeutic selection to select respective radio-frequency frequency, frequency range 230KHz��20MHz), and set treatment parameter (such as treatment power, treatment energy, the frequency selected, therapeutic electrode selects, treatment temperature), then issue an order to microprocessor A1, make it control rf frequency selection circuit A3 and radio frequency circuit for generating A4 and produce corresponding radiofrequency signal, and control microelectrode switch selection circuit A5, open corresponding electrod-array, power in Real-time Feedback therapeutic process and energy simultaneously, then cold medium circulation system C is controlled according to the treatment power of feedback with the parameter further regulable control radio frequency circuit for generating A4 and cold medium circulation control circuit A8 of energy, thus reaching the protective effect of the treatment to atheromatous plaque and blood vessel endothelium.
As shown in Figure 1; the cold medium circulation system C of described atherosclerosis guiding target treatment device sends modulation signal mainly by treatment control system A; control the rotating speed of peristaltic pump, to control cold velocity of medium, thus reaching the cooling protection effect to treatment blood vessel endothelium.
Radio frequency microelectrode E1
As shown in Figure 2, described atherosclerosis targeted therapy balloon-system E, mainly include sacculus E3, radio frequency microelectrode array E1, foley's tube E2 etc., radio frequency microelectrode array E1 have employed specific processing technique, according to certain specification arrangement, it is burnt on treatment radio frequency sacculus, and the work of each microelectrode is independent from, corresponding sacculus microelectrode can be selected to carry out targeting conformal therapy according to corresponding Patch size over the course for the treatment of.
Radio frequency microelectrode array E1 draws mainly by the wire on sacculus E3 surface and conduit E2 surface, then, treatment control system A is being accessed by flexible cable D, form treatment path, with cold medium circulation system inside foley's tube E2, for passing through to regulate the flow velocity of cold medium circulation system over the course for the treatment of, thus regulating the temperature of balloon surface, reduce the temperature of blood vessel endothelium, thus ensure that therapeutic process Vascular Endothelial is injury-free.
Embodiment 2: atherosclerosis guiding target treatment device No.2
The connection figure of the present embodiment atherosclerosis guiding target treatment device refers to Fig. 1, described device controls the system concrete condition according to atheromatous plaque mainly by atherosclerosis targeted therapy, control the radiofrequency signal of corresponding frequencies and the conformal radio frequency microelectrode opened on sacculus, thus reaching the therapeutical effect to atheromatous plaque. Described device includes treatment control system A, power supply B, cold medium circulation system C, flexible cable D, sacculus E, wherein, treatment control system is made up of microcontroller A1, touch control display module A2, rf frequency selection circuit A3, radio frequency circuit for generating A4, electrode switch selection circuit A5, power/energy feedback circuit A6, radio frequency interface A7, cold medium circulation control circuit A8 etc., and wherein A3, A4, A5 constitute radio-frequency (RF) therapy described above control. According to specific standard, described sacculus E requires that distribution has treatment radio frequency microelectrode, described radio frequency microelectrode is to be burnt at balloon surface by specific process technology to draw with supravasal microelectrode lead, then pass through flexible cable D access control system, form treatment control access.
As shown in Figure 1, the treatment control system A of described atherosclerosis guiding target treatment device is mainly used for the power controlling radio frequency and energy and the corresponding conformal radio frequency microelectrode of selection, and control cold medium circulation system, thus reach the targeted therapy to atheromatous plaque. it is in the course of the work, shape according to corresponding speckle, volume, size, corresponding conformal radio frequency microelectrode is selected by touch screen A2, and select respective radio-frequency frequency, and set treatment parameter, then issuing an order makes it control rf frequency selection circuit A3 and the radio frequency circuit for generating A4 corresponding radiofrequency signal of generation to microprocessor A1, and control microelectrode switch selection circuit A5, open corresponding electrod-array, power in Real-time Feedback therapeutic process and energy simultaneously, then cold medium circulation system is controlled according to the treatment power of feedback with the parameter further regulable control radio frequency circuit for generating A4 and cold medium circulation control circuit A8 of energy, thus reaching the protective effect of the treatment to atheromatous plaque and blood vessel endothelium.
As shown in Figure 1; the cold medium circulation system C of described atherosclerosis guiding target treatment device sends modulation signal mainly by control system; control the rotating speed of peristaltic pump; to control cold velocity of medium; thus reaching the cooling protection effect to treatment blood vessel endothelium; wherein cold medium can be external by being back to, or is flowed in blood vessel by the another port of sacculus.
As shown in Figure 2, described atherosclerosis targeted therapy sacculus E, mainly include sacculus E3, radio frequency microelectrode array E1, foley's tube E2 etc., described radio frequency microelectrode E1 have employed specific processing technique, according to certain specification arrangement, it is burnt on treatment radio frequency sacculus, and the work of each microelectrode is independent from, corresponding sacculus microelectrode can be selected to carry out targeting conformal therapy according to corresponding Patch size over the course for the treatment of; Described electrode is drawn mainly by the wire in balloon surface and catheter surface, then, instrument is being accessed by flexible cable, form treatment path, with cold medium circulation system inside described foley's tube, for passing through to regulate the flow velocity of cold medium circulation system over the course for the treatment of, thus regulating the temperature of balloon surface, reduce the temperature of blood vessel endothelium, thus ensure that therapeutic process Vascular Endothelial is injury-free.
Embodiment 3: atherosclerosis guiding target treatment device No.3
A kind of atherosclerosis guiding target treatment device, described device includes: treatment control system, power supply, SAPMAC method system, flexible cable, treats sacculus; Described treatment controls system and includes microcontroller, touch control display module, rf frequency selection circuit, radio frequency circuit for generating, electrode switch selection circuit, power/energy feedback circuit, radio frequency interface, cold medium circulation control circuit etc.
Described treatment sacculus is in the course of the work, it is deep into internal blood vessel to be treated, then to balloon interior saline injection, from but whole sacculus is in the state of propping up, and then make the electrode on sacculus can effectively touch treatment vascular plaque to treat.
Described treatment controls system and mainly controls radio frequency circuit for generating; corresponding treatment electrode on sacculus is sent radiofrequency signal by radio frequency microelectrode switch selection circuit; with the treatment to atheromatous plaque; control cold medium circulation system at therapeutic process the cooling of blood vessel endothelium is processed simultaneously; thus the protection reaching therapeutic process Vascular Endothelial is unlikely to damage because for the treatment of; and parameter can be treated accordingly by Real-time Feedback over the course for the treatment of, for the feedback parameter in therapeutic process to regulate the output of circuit in real time. And treatment information can be shown on touch screen in real time.
Present invention is disclosed a kind of atherosclerosis guiding target treatment device, described therapy equipment is embodied as comprising the steps:
Step S1: adopt Angiography technology to carry out realtime imaging and navigation in the present invention, observe information such as measuring the size of vascular plaque to be treated, size, the degree of depth, the information according to detection, it is judged that therapeutic scheme, treat.
Step S2: will not be filled with the sacculus of liquid according to angiographic imaging information navigation, it is deep into treatment internal blood vessel, after arriving relevant position, to treatment balloon interior saline injection or associated media, make it prop up, so that the electrode of balloon interior can be adequately exposed to treatment speckle, to reach the purpose for the treatment of
Step S3: according to the blood vessel specifying information of imaging system feedback in art, it is judged that open corresponding conformal radio frequency microelectrode, and select corresponding therapeutic frequency to arrive effective treatment; Then, selected relevant work electrode and rf frequency by touch screen, promote microprocessor to control related circuit work, reach the treatment to atheromatous plaque.
Step S4: over the course for the treatment of, the relevant parameters such as Real-time Collection balloon surface temperature, treatment power and treatment energy, then system is according to relevant parameter as feedback adjustment signal, controls the co-ordination of whole system, and controls the flow velocity of cold medium circulation system at therapeutic process. With the cooling to tunica intima, thus playing the protective effect to tunica intima.
The beneficial effects of the present invention is the Therapeutic Method tightly not disclosing a kind of atherosclerosis guiding target treatment device with system, also described invention device is employed bionical fabric texture glue simultaneously and is simulated treatment test, the thermal infrared imager used in test process is that FLIR company of the U.S. produces (FLIRSystems, Inc.Wilsonville, US) carry out the real-time distribution tests treating temperature field. Test microelectrode heating respectively and change over trendgram such as Fig. 3 (heating time period of every width figure is 20s) in the Temperature Distribution of expandable prosthetic generation; Different radio frequency number of electrodes (six electrodes and five electrodes) impact such as Fig. 4 (left: six electrodes, right: five electrodes), its corresponding 3D Temperature Distribution such as Fig. 5 produced on tissue heating efficiency; And contrast test identical electrodes is after balloon interior adds the aqueous water treatment 50s of 16 DEG C, 12 DEG C, 35 DEG C by cooling water circulation passageway, the temperature field for the treatment of tissue inner membrance and thermo parameters method such as Fig. 6 for the treatment of tissue are (left: to pass into 16 DEG C of cooling water, in: pass into 12 DEG C of cooling water, right: to pass into the aqueous water close with body temperature 35 DEG C), its corresponding 3D Temperature Distribution such as Fig. 7 produced.
In sum, a kind of atherosclerosis guiding target treatment device provided by the invention, not only providing a kind of instrument and equipment being applied to atherosclerotic treatment, also provide for the Therapeutic Method in therapeutic process, the feasibility simultaneously for its principle is tested. Be one simple to operation; high efficiency, low complex degree treatment medical instrument; it is capable of the thorough treatment selectively to atheromatosis, and can over the course for the treatment of effectively tissue be protected, solve the associated treatment problem of atheromatous plaque.
In sum, a kind of atherosclerosis guiding target treatment device provided by the invention, not only providing a kind of instrument and equipment being applied to atherosclerotic treatment, also provide for the Therapeutic Method in therapeutic process, the feasibility simultaneously for its principle is tested. Be one simple to operation; high efficiency, low complex degree treatment medical instrument; it is capable of the thorough treatment selectively to atheromatosis, and can over the course for the treatment of effectively tissue be protected, solve the associated treatment problem of atheromatous plaque.
Test case
Above-mentioned atherosclerosis guiding target treatment device is employed bionical fabric texture glue and is simulated treatment test by applicant, the thermal infrared imager used in test process is that FLIR company of the U.S. produces (FLIRSystems, Inc.Wilsonville, US) carry out the real-time distribution tests treating temperature field.
The Temperature Distribution that microelectrode heating produces at expandable prosthetic changes over shown in trendgram such as Fig. 3 (heating time period of every width figure is 20s), propelling over time, the effect of sacculus heating is more and more significant, and the temperature of expandable prosthetic rises and is also apparent from.
When being 6 radio frequency microelectrodes and 5 radio frequency microelectrodes with right side resolution on the left of Fig. 4, the impact on tissue heating efficiency, (heating region that different amounts of microelectrode can reach is different). Further, Fig. 5 illustrates the corresponding 3D Temperature Distribution produced under above-mentioned condition. The reduction of multi-pair electrodes temperature " point effect " so that the form of the Temperature Distribution around multi-electrode is partial to " area big and peak value is little ".
Left, center, right in Fig. 6 are identical radio frequency microelectrodes respectively after balloon interior adds the aqueous water treatment 50s of 16 DEG C, 12 DEG C, 35 DEG C by cooling water circulation passageway, the temperature field for the treatment of tissue inner membrance and the thermo parameters method for the treatment of tissue, (in sacculus, the Temperature Distribution of radio frequency expandable prosthetic is affected very big by the temperature of cooling medium). Further, Fig. 7 illustrates the corresponding 3D Temperature Distribution produced under above-mentioned condition, illustrates that balloon interior cooling medium is most important on the impact of therapeutic outcome.
The all documents mentioned in the present invention are incorporated as reference all in this application, are individually recited as reference such just as each section of document. In addition, it is to be understood that after the above-mentioned teachings having read the present invention, the present invention can be made various changes or modifications by those skilled in the art, these equivalent form of values fall within the application appended claims limited range equally.
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