CN108031006A - A kind of wireless pacemaker delivery conduit device turned to memory alloy wire control and production method - Google Patents
A kind of wireless pacemaker delivery conduit device turned to memory alloy wire control and production method Download PDFInfo
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- CN108031006A CN108031006A CN201810068374.5A CN201810068374A CN108031006A CN 108031006 A CN108031006 A CN 108031006A CN 201810068374 A CN201810068374 A CN 201810068374A CN 108031006 A CN108031006 A CN 108031006A
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- delivery conduit
- alloy wire
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0266—Shape memory materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/36—General characteristics of the apparatus related to heating or cooling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/12—Blood circulatory system
- A61M2210/125—Heart
Abstract
The invention belongs to interventional medical device field, and in particular to a kind of wireless pacemaker delivery conduit device turned to memory alloy wire control and production method.Include joystick on the delivery conduit apparatus structure, delivery conduit, the specific device and control system of distal end of catheter, it is characterized mainly in that the electric current that memory alloy wire is passed through by handle integrated control, the different length change of every B alloy wire is realized to realize the bending function of delivery conduit, and angle of bend is shown on the display screen of control system, to realize the Digital Control of angle of bend, wherein control system has data record and upload function, the implantation path of medical treatment device can be recorded and be uploaded, to optimize implantation path, wherein the present invention makes delivery conduit by way of gluing again pyrocondensation.The present invention can precisely and easily realize the Digital Control of guiding-tube bend function, shorten Implantation Time, improve implantation security, have preferable application prospect in the conveying of wireless pacemaker.
Description
Technical field
The invention belongs to interventional medical device field, and in particular to a kind of to control bending to turn to and lead to by memory alloy wire
The method for crossing wireless pacemaker delivery conduit device prepared by lamination heat shrink technique.
Background technology
Arrhythmia cordis refers to that the rhythm of the heart origin any one or more such as position and rhythm of the heart frequency, the rhythm and pace of moving things and impulse conduction is different
Often, it is one of clinical common cardiovascular disease, is broadly divided into feature and two kinds organic.Feature it is more with it is excited,
Stress, vegetative nerve functional disturbance, cardiac neurosis etc. are related；It is organic more by coronary heart disease, rheumatic heart disease, cardiomyopathy
Etc. causing, when acute myocardial infarction AMI, is particularly common, is the major reason for causing death.There are 17,000,000 people in the whole world because of painstaking effort every year
Pipe disease and it is dead；In the Asian-Pacific area, especially the trend of rising is showed, has been had in China, the incidence of angiocardiopathy
There is an urgent need to treat for substantial amounts of patients with arrhythmia；The patient of China's annual arrhythmia cordis at present reaches 20,000,000, wherein 540,000
People's premature death due to heart failure.
Implanted pacemaker technology is the first-line treatment means of arrhythmia cordis at present.Pacemaker is that one kind is implanted in body
Interior electronic therapeutic instrument.Traditional wired pacemaker usually sends electricity by the impulse generator being implanted under subcutaneous or muscle
Pulse, the cardiac muscle contacted by the conduction stimulating electrode of conducting wire, makes heart excitement and shrinks, so as to reach treatment due to some
The purpose of arrhythmia caused heart dysfunction.Although there is the conventional pacemakers implant surgery counted with 100,000 every year,
It is to still suffer from some clearly disadvantageous parts, as the corrosion of impulse generator and connecting position of wires even disconnects phenomenon, with conducting wire
The high incidence of related severe complication, aesthetics after implant surgery etc..In order to solve the short slab of conventional pacemaker, nothing
Line pacemaker comes into being.It can be said that wireless pacemaker has started the Second Revolution of pacemaker.As shown in Figure 1, wireless pacemaker
Device 100 is fixed by the sensing electrode 141,142 of the battery 120, circuit board 130 and the outside that are sealed in titanium alloy casing 110
Device 150, trap setting 160 form.In certain embodiments, fixing device 150 is also designed to helical form, is grasped by rotating
Pacemaker is fixed in cardiac muscle by work.Wireless pacemaker 100 is fixed in 260 sheath of distal end of catheter by tether 170, is implanted into
Cheng Zhong, wireless pacemaker 100 is sent to inferior caval vein (IVC) via femoral vein, sheath sequentially enter to atrium dextrum (RA) and
In right ventricle (RV), discharge pacemaker and be fixed in cardiac muscle.The whole implant surgery time is short, and wound is small, and is not required to
Conducting wire is chronically implanted, reduces the breaking-out of complication to the full extent.During wireless heart Pacemaker implantation, conveying device
Play the role of to the success or not of operation operation vital, it is desirable to which conveying device has and also to have one while enough rigidity
Fixed flexibility, enables conveying device circuitous forward in vein or artery, and can realize that accurately bending turns to work(
Can, it is finally reached target location.
Currently used wireless pacemaker transport system is to realize bending turning function by the bracing wire in conduit mostly,
Such as United States Patent (USP)（US 8,721,587 B2、US 8,945,146 B2、US 2014/0249543 A1）And Chinese patent
（CN103945899A）Disclosed, it uses the material of different hardness to cause conduit to have the classification flexibility in axial direction, and
Distal end of catheter bending is had a certain degree by thermosetting process, can also be further by bracing wire during Pacemaker implantation
Adjust angle of bend.
Chinese patent CN103619395A disclose it is a kind of apply it is in ablation catheter field, by memory alloy wire and add
The mode of thermal element coupling controls the method that conduit turns to, which changes memory alloy wire by the temperature change of heating element
Temperature, so as to fulfill memory alloy wire from first shape to the change of the second shape.
External article Batch fabricated at meandering shape memory alloy actuator
For active catheter, Multi-functional Active Catheter etc. are reported on utilizing memorial alloy
The conduit for kidney ultrasonoscopy that silk control turns to, which is 2-3mm.Memory alloy wire is located at ectonexine conduit
Between, three B alloy wires are radially uniformly distributed conduit, by polymer and lining ring or bonding agent and lining ring by B alloy wire
It is fixed.Memory alloy wire is fabricated by electrochemical etching technology, controls the length of B alloy wire by pulse current so as to control
System turns to.
In terms of conduit making, Chinese patent CN101443068A disclose it is a kind of by pyrocondensation mode by conduit liner,
The method that flat pull, mesh grid and outer tube are fused into one.The invention provides a core bar first, then that liner is flat
Bracing wire, mesh grid and outer tube and heat-shrink tube are respectively placed in interior lining from inside to outside, after heating under the action of heat-shrink tube, make
Cladding material is circumferentially flowed and redistributed, and most mesh grid and flat pull coat at last, form one.
The present invention is using the memory alloy wire control angle of bend of mounted in pairs, and angle of bend real-time display is in control system
Display screen on, can precisely and easily realize the Digital Control of angle of bend；The control system tool of delivery conduit device
There is data recording function, be able to record that the figure and features such as height, weight of patient feature and forward displacement, guiding-tube bend angle etc. are implanted into
Parameter, can more accurately instruct implantation path after analysis.The invention discloses a kind of method of gluing pyrocondensation again, by difference
The outer tube of material and different-diameter is coated in the inner tube and mesh grid for scribbling glue, and the connection for enhancing ectonexine pipe is strong
Degree.
The content of the invention
Turned to and using memory alloy wire control bending by being laminated heat shrink technique it is an object of the invention to provide one kind
The method of the wireless pacemaker delivery conduit device with data recording function of manufacture.In order to realize above-mentioned technical characterstic, this
The technical solution of invention is：
Curved guide memory alloy wire is symmetrically installed in pairs, and being placed on needs in the fluting of curved inner conductor distal end, paired
Memory alloy wire passes to different electric currents and by joystick integrated control so that the different length change of every B alloy wire is so as to reality
The bending function of conduit can now be turned to.Before and after implant surgery, control system is by the figure and features such as the height of patient and weight feature with rising
The implantation such as the forward displacement of device, guiding-tube bend angle parameter of fighting carries out recording transmission terminal, by statistics and big data analysis,
Optimization implantation path parameter and the relation of patient's figure and features feature.Outer conductor by different materials, different-diameter several sections of conduit groups
Into multistage outer conductor is coated on inner conductor and mesh grid by way of gluing again pyrocondensation, one is ultimately formed and leads
Pipe.Beneficial effects of the present invention are：
1. the angle of bend of delivery conduit can be visualized, Neng Goujing by joystick integrated control in implantation process
The Digital Control of angle of bend is realized accurately；
2. by the relation for optimizing patient's figure and features feature with being implanted into parameter, transport system is improved to different patient's relevance grades；
3. making delivery conduit by way of gluing again pyrocondensation, the bonding strength of ectonexine conduit is enhanced, is had broad
Conduit material use scope.
Brief description of the drawings
Figure 1A is the structure diagram of wireless pacemaker.
Figure 1B is that wireless pacemaker is fixed on distal end of catheter schematic diagram.
Fig. 1 C are wireless Pacemaker implantation process schematics.
Fig. 2A is the overall schematic of delivery conduit.
Fig. 2 B are the overall schematics of delivery conduit inner conductor.
Fig. 2 C are the overall schematics of delivery conduit outer conductor.
Fig. 3 A are the section figures of delivery catheter distal end.
Fig. 3 B are the section figures of delivery conduit interlude.
Fig. 3 C are the section figures of delivery conduit interlude.
Fig. 3 D are the section figures of delivery conduit near-end.
Fig. 4 A are flexure mems B alloy wire control schematic diagrams.
Fig. 4 B are multigroup flexure mems B alloy wire placement location schematic diagrames.
Fig. 4 C are multigroup flexure mems B alloy wire placement location schematic cross-sections.
Fig. 5 A are control system composition schematic diagrams.
Fig. 5 B are electrode placement positions schematic diagrames.
Fig. 6 is lamination pyrocondensation process schematic representation.
Fig. 7 is lamination shrinkage apparatus schematic diagram.
Fig. 8 is that delivery catheter distal end is equipped with ablating electrode schematic diagram.
Fig. 9 is that delivery catheter distal end is equipped with plugging device schematic diagram.
Embodiment
Presently preferred embodiments of the present invention is described in detail below in conjunction with the accompanying drawings, so that advantages and features of the invention energy
It is easier to be readily appreciated by one skilled in the art, so as to make a clearer definition of the protection scope of the present invention.
Fig. 2 is a preferred embodiment appearance schematic diagram of delivery conduit device according to the present invention, and delivery conduit 200 has
It is four sections of changes in material, the diameter changes of conduit in the axial direction respectively to have distal end 210 and near-end 290,220,230,240 and 250
Run, wherein run 250 is using the larger biocompatible material of hardness, 220,230 and 240 3 sections of run
Then using the hardness implantable material smaller than run 250.As alternative embodiment, run 220 can use softer
Biocompatible material.The diameter of run 250 is maximum, and specific size can be 6F-23F.The diameter ratio of run 240
250 is small, and the diameter of run 230 is bigger than run 240, and its object is to conduit is had less bending journey in the section
Degree, so as to fulfill more accurately bending, the diameter of run 220 is minimum, is easiest to realize bending in this section of conduit, is conducive to defeated
Device is sent to reach atrium dextrum and right ventricle via inferior caval vein.Distal end of catheter 260 has specific device, such as sheath, electrode, magnetic
Iron catcher either other mechanical structures available for conveying, fetch medical treatment device or melted, the operation such as diagnose.Control
Handle 270 controls the propulsion and bending of delivery conduit.Inner conductor 300 is multi-lumen tube, and proximally arriving distal end has unanimously
Material properties and diameter.The material and architectural characteristic of whole delivery conduit 200 are realized by the characteristic of outer conductor 400.
Fig. 3 is the section figure that delivery conduit 200 corresponds to run.Wherein, inner conductor 300 is multi-lumen tube, inner cavity
It is evenly distributed in catheter section, the polytetrafluoroethylene material that materials'use lubricity is preferable, fusing point is higher.
Marmem is to cause changed kind of intellectual material of its own shape by temperature change, has and replys
The advantages that power is big, corrosion-resistant, good biocompatibility.As shown in figure 3, curved guide memory alloy wire 510 and 520 is symmetrical in 180 °
Ground is placed in the distal end fluting of inner conductor 300, controls the flexural deformation of delivery catheter distal end.Each pair memory alloy wire is all
It is square memory wire to contain two sections.According to one embodiment of present invention, using pwm pulse electric current to memorial alloy
Silk is heated, and the type of cooling is natural cooling.The deformation temperature of the memory alloy wire of selection is 60 DEG C or so, and cooling temperature is
40 DEG C or so.In order to avoid influence of the memory alloy wire temperature rise to implant surgery, between inner conductor 300 and mesh grid 350
Spray adiabatic gum.As shown in figure 4, the memory alloy wire 511 and 512 to mounted in pairs passes to different pwm pulse electric currents, every
Memory alloy wire is heated temperature rise degree difference, result in every memory alloy wire in catheter shaft different length change upwards, from
And realize the flexural deformation to memory wire.Insulating layer 600 is covered between memory alloy wire, is avoided on every memory alloy wire
Electric current and temperature interfere.The electric current of every memory alloy wire is realized by 270 integrated control of joystick by control button
The consecutive variations of angle of bend, in this way, doctor can be controlled in implantation process according to the individual difference of patient it is different curved
Bent angle, realizes the accurate implantation of pacemaker.
In different implementation scenarios, multigroup memory alloy wire is placed in the axial direction of delivery conduit knee, such as Fig. 4 B institutes
Show.During implementing bending steering, control successively first group (510,520), second group (530,540) and the 3rd group
The temperature change of (550,560) memory alloy wire, it is possible to achieve delivery conduit more accurately bends and realize the bending of bigger
Angle.As shown in Figure 4 C, in the radially symmetrically placed multipair memory alloy wire of delivery conduit, conduit at least two can be realized
Bending in plane.
The electric current of memory alloy wire is provided by the power supply in control system, and conducting wire is passed through in conduit by joystick 270
Chamber is connected on memory alloy wire.System composition schematic diagram in order to control as shown in Figure 5A, the control system by power supply, display,
Integrated circuit and central processing unit composition, can not only realize the Digital Control of angle of bend, and have data record, deposit
Storage and bluetooth upload function.When carrying out wireless artificial or electronic heart pacemaker implant surgery, three pairs of electrodes are respectively placed in the body surface of patient,
As shown in Figure 5 B, electrode 711 and 712 is individually positioned in patient's neck and lower extremity；Electrode 721 and 722 is placed on patient's
Flank；Electrode 731 and 732 is placed on the front and rear thoracic cavity position of patient.The three-dimensional coordinate of wireless pacemaker is produced in three pairs of electrodes
Magnetic field or electric field in uniquely determine.Conveying device with wireless artificial or electronic heart pacemaker is entered into internal, the control system by femoral vein
Beginning records the positional information of wireless artificial or electronic heart pacemaker in real time；It is pushed further into delivery conduit crossing to inferior caval vein and atrium dextrum
Place, doctor are observed the position of artificial or electronic heart pacemaker by X-ray equipment, delivery catheter distal end are realized by the manipulation knob on joystick
Bend for the first time so that the sheath of distal end of catheter enters atrium dextrum, at this time by the store function of control system by display
Bent angle alpha record.The angle of bend of bigger, then secondary control are needed when the sheath of distal end of catheter passes through tricuspid
Manipulation knob on handle realizes second of bending of delivery catheter distal end, and angle of bend β, angle of bend is recorded simultaneously
Continuing to promote conduit so that the sheath of distal end of catheter eventually arrives at apex of the heart position, after the completion of artificial or electronic heart pacemaker parameter adjustment, release
Wireless artificial or electronic heart pacemaker, releases conveying device.Control system records whole transport path, uploads and carries out statistical analysis, leads to
The data analysis for crossing large sample has finally obtained the transport path of an optimum optimization.
As shown in figure 3, mesh grid 350 is tightly coated on 300 outer wall of inner conductor, only conduit does not provide the branch of radial direction
The pushability of support force and enhancing axial direction, and during implanting, prevent conduit overstress bending.According to some
Embodiment, the density of the upward mesh grid of catheter shaft is adjusted by adjusting the speed of braider draw-gear, proximally arrives distal end
Count gradually become sparse, add 210 curved flexibility of delivery catheter distal end, such as count proximally arrives
Distal end is reduced to 30 PPI by 70 PPI.Mesh grid is using 16 ingots, two lower weaving manner on two, and angle of weave is 54 °, use
Square-section, sectional dimension substantially 0.02mm × 0.15mm.
Outer conductor section 420,430,440 and 450 has different wall thickness, be respectively 0.1mm, 0.3mm, 0.2mm and
0.5mm, wherein outer conductor section 420,430 and 440 use softer implantable material, so that the distal end of delivery conduit is with good
Good flexible, and catheter injury body vessel and the risk of tissue can be reduced, the material of outer conductor section 450 is led than other
Pipeline section material is hard, can pushability and torsion transitivity with strengthen delivery conduit.The length of outer conductor section 450 is longer, about
90cm, the length of run 420,430 and 440 is respectively 5cm, 3cm and 5cm.In the present invention, according in delivery conduit axial direction
Hardness feature, using different hardness, the medical grade PEBAX materials of the trade mark, such as France ARKEMA, the product of EMS companies of Switzerland.
In order to make intervention delivery conduit have good pushability and a torsion transitivity, the rigidity in delivery conduit axial direction is
Change.The present invention is using the outer conductor of different materials and different-diameter by being laminated mesh grid by the way of pyrocondensation, bending
Guide memory B alloy wire and inner conductor are fused into an intervention delivery conduit.As shown in Figure 6,7, mesh grid 350 is woven in
It placed on 300 outer wall of inner conductor of curved guide memory alloy wire, equably applied in mesh grid by glue coating machine
One layer of glue, several sections of outer conductors of different materials, different-diameter are sleeved in mesh grid, then by 800 sets of heat-shrink tube outside
On layer conduit, whole conduit is clamped on draw-gear 910,920 and passes through the center of heating ring 1000, whole conduit
Slowly uniformly across heating ring.According to the deformation temperature of heat-shrink tube and the suitable heating of the fusion temperature of ectonexine conduit setting
Temperature.Heat-shrink tube 800 is equably shunk so as to which outer conductor and mesh grid stick together to form one whole conduit after heating.
According to preferred embodiment, the crest clearance control of the internal diameter of outer conductor after extrusion and inner conductor 0.1 ~
Between 0.5mm, the gap determine to ensure after mesh grid gluing outer conductor can ground be sleeved in mesh grid, and when hot
Avoided after 800 heat shrinkable of the draw due to there is unbonded phenomenon between the excessive outer conductor in gap and mesh grid.Heat-shrink tube selects
Select the not high medical grade PVC of deformation temperature, PET or PE materials, its purpose：First, avoid the PEBAX pipes of outer layer from melting
Phenomenon, second avoids glue from being hardened or fail since temperature is excessive.The selection of glue has claimed below：Selected heat can be withstood
The pyrocondensation temperature of the draw；Mesh grid and outer conductor material can be bonded；Hardness cannot be too big after glue curing, otherwise can influence
The rigidity of conduit.The present invention uses PE heat-shrink tubes, and the temperature for heating ring is set in 80 DEG C.
According to one embodiment of present invention, as shown in Figure 8,9, catheter delivery device distal end 260 can be turned to can also be
Fixed electrode 1110 to carry out ablative surgery, or plugging device 1120 and mechanical structure known in the art carry out it is related
Intervention operation.
The foregoing is merely presently preferred embodiments of the present invention, is not intended to limit the invention, all in the spiritual and former of invention
The modification made within then, equivalent substitution, improvement etc., should all be comprising within the scope of the present invention.
Claims (25)
1. a kind of wireless pacemaker delivery conduit device turned to memory alloy wire control and production method, its primary clustering bag
Include：
The inner conductor of two chambers or multi-cavity structure；
The memory alloy wire that controllable bending turns to；
Strengthen the metal net of mechanical strength；
The outer conductor being made of the multistage conduit of identical or different material, different-diameter；
Distal end has the device of specific function, such as sheath, electrode, magnet catcher or other mechanical structures；
Catheter control systems.
2. delivery conduit device according to claim 1, it is characterised in that：The inner conductor can be two chambers or
Multi-cavity, a diameter of 3F-30F.
3. delivery conduit device according to claim 1, it is characterised in that：Slot needing curved inner conductor distal end
In, the curved guide memory alloy wire forms in pairs, is symmetrically installed.
4. delivery conduit device according to claim 1, it is characterised in that：The inner conductor and the bending are led
Coated to memory alloy wire by one layer of metal net；In another case, mesh grid and memory alloy wire are distributed in respectively
The upward different sections of distal catheter shaft.
5. delivery conduit device according to claim 1, it is characterised in that：The outer conductor by different materials, no
Formed with several sections of conduits of diameter or wall thickness so that the rigidity that the intervention delivery conduit proximally arrives distal end is gradually reduced；
In another case, the outer conductor is made of several sections of conduits of identical material, different-diameter or wall thickness.
6. curved guide memory alloy wire component according to claim 3, it is characterised in that：Paired memory alloy wire connects
Contacting surface links together, and passes to different electric currents and is respectively heated, and causes the different length change of every B alloy wire so as to reality
The bending function of existing delivery conduit；Multipair memory alloy wire is installed in the different parts of delivery catheter distal end, by controlling wherein
A pair of or several bendings for causing the delivery catheter distal end to realize different angle, Different Plane to memory alloy wire.
7. curved guide memory alloy wire component according to claim 6, it is characterised in that：Pass through the electricity of memory alloy wire
Flowing by joystick integrated control, can realize the consecutive variations of delivery conduit angle of bend；The angle of bend of delivery conduit is real
When be shown on the display of control system, it is achieved thereby that the Digital Control of delivery conduit.
8. outer conductor component according to claim 5, it is characterised in that：The outer conductor includes at least two sections of materials
Expect attribute and two sections of diameters or wall thickness.
9. outer conductor component according to claim 8, it is characterised in that：The existing enough rigidity of delivery conduit,
Also there is suitable flexibility, which realized by the material and architectural feature of the outer conductor.
10. outer conductor component according to claim 9, it is characterised in that：Form the material of the outer conductor from
The hardness of near-end to distal end is gradually reduced, such to design the bending for not only improving delivery conduit, while is also beneficial to reduction and is led
Injury of the pipe in implantation process to human vas tissue and heart tissue.
11. outer conductor component according to claim 9, it is characterised in that：In terms of guide-tube structure, the delivery conduit
The diameter of outer conductor in axial direction is gradually reduced so that distal end of catheter is easier to realize bending.
12. delivery conduit device according to claim 1, it is characterised in that：The device of the distal end of catheter can be sheath
Pipe, electrode, magnet catcher or other mechanical structures, to realize that the conveying of different medical apparatus, taking-up etc. operate, Yi Jiying
The interventions such as the ablative surgery for atrial fibrillation are performed the operation, these devices may include other plants such as wireless pacemaker, plugging device, cardiac valves
Enter internal medical instrument.
13. delivery conduit device according to claim 1, it is characterised in that：Catheter control systems by power supply, display,
Integrated circuit and central processing unit composition；
Delivery conduit device according to claim 1, it is characterised in that：The control system tool of the delivery conduit device
There is data recording function.
14. before implant surgery, the figure and features feature such as the height of patient and weight is input in conveying device；In implant surgery
Cheng Zhong, monitors the three-dimensional coordinate position of medical treatment device, forward displacement, guiding-tube bend is drawn according to the height of patient and weight in real time
Angle etc. is implanted into parameter；After implant surgery, by transmission terminal in the data；By statistics and big data analysis, optimization implantation
Path parameter and the relation of patient's figure and features feature, so as to more accurately instruct implantation path.
15. one kind is using heat shrink technique manufacture delivery conduit device, step is laminated：
The extrusion of inner conductor；
Curved guide memory alloy wire is placed on during inner conductor distal end is slotted to control the angle of distal end device, direction；
Metal knitted silk is woven on inner conductor outer wall using braider；
One layer of glue is uniformly coated in mesh grid using glue coating machine, it is straight then to coat several sections of different materials, difference
The outer conductor in footpath；
Heat-shrink tube is coated on several sections of outer conductors；
The conduit assembled is passed through into heating unit（Heat ring, or other equipment）, both ends are clamped on draw-gear, protect respectively
Certain tightening force is held, prevents that memory alloy wire is deformed due to heated during heating；
The temperature of heating unit is transferred to the shrinkage temperature of heat-shrink tube so that heat-shrink tube uniform shrinkage；
Cooling, etc. removing heat-shrink tube after glue curing, so that inner conductor, flexure mems B alloy wire, mesh grid and outer layer
Conduit becomes a conduit.
16. according to the method for claim 15, it is characterised in that：The delivery conduit is according to implantation position and the device of implantation
Part determines its outside diameter.
17. according to the method for claim 15, it is characterised in that：The inner conductor material can be PTFE or intervention
The material of the common medical grade bio-compatibility in field, such as nylon, PEBAX, PC, PP, polyurethane.
18. according to the method for claim 15, it is characterised in that：The flexure mems B alloy wire can use common
Ti-Ni base marmem materials, or other memory alloy materials.
19. according to the method for claim 15, it is characterised in that：The mesh grid provides radial direction for the delivery conduit
The pushability of support force and enhancing axial direction, and during implanting, avoid the excessive bending of conduit.
20. according to the method for claim 15, it is characterised in that：The heat-shrink tube extrudes outer layer after heat shrinkable and leads
Pipe, promotes during this glue to flow so that the glue is evenly distributed on mesh grid periphery.
21. according to the method for claim 15, it is characterised in that：The glue uses soft glue, prevent cure after its
Hardness is too high and to influence the rigidity of the conduit.
22. according to the method for claim 15, it is characterised in that：The shrinkage temperature of heat-shrink tube will be less than inner conductor and outer
The melt temperature of layer conduit, for example select the relatively low material contracting with heat of the shrinkage temperatures such as medical rank PVC, PET or PE.
23. according to the method for claim 15, it is characterised in that：In the pyrocondensation stage, the conduit of heat-shrink tube is cased with by leading
Leading-in device passes through the center of heating ring so that heat-shrink tube being capable of thermally equivalent and contraction.
24. according to the method for claim 15, it is characterised in that：After glue curing, remove heat-shrink tube, use heat gun
The outer conductor seam crossings of several sections of different-diameters, different materials fused Deng heating unit so that the smooth smooth-going of whole conduit.
25. delivery conduit according to claim 1, it is characterised in that：It is described to turn to conduit and pass through interruption
The technologies such as co-extrusion technology, outer wall coating are realized the outer conductor of several sections of different materials, different-diameter is coated outside mesh grid
On wall.
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| CN201810068374.5A CN108031006A (en) | 2018-01-24 | 2018-01-24 | A kind of wireless pacemaker delivery conduit device turned to memory alloy wire control and production method |
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| CN201810068374.5A CN108031006A (en) | 2018-01-24 | 2018-01-24 | A kind of wireless pacemaker delivery conduit device turned to memory alloy wire control and production method |
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| CN114470487A (en) * | 2021-12-22 | 2022-05-13 | 广东博迈医疗科技股份有限公司 | Medical guide wire and interventional medical equipment |
| CN117339108A (en) * | 2023-12-04 | 2024-01-05 | 山东瑞安泰医疗技术有限公司 | Leadless cardiac pacemaker system capable of reducing pacing threshold and accurately positioning |
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