CN204469005U - A kind of split implantable medical devices of MRI compatible - Google Patents

A kind of split implantable medical devices of MRI compatible Download PDF

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Publication number
CN204469005U
CN204469005U CN201520035805.XU CN201520035805U CN204469005U CN 204469005 U CN204469005 U CN 204469005U CN 201520035805 U CN201520035805 U CN 201520035805U CN 204469005 U CN204469005 U CN 204469005U
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China
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sleeve
medical devices
implantable medical
biocompatibility
mri compatible
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姜长青
莫晓龙
董延涛
李路明
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Beijing Pins Medical Co Ltd
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Tsinghua University
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Abstract

This utility model relates to a kind of split implantable medical devices of MRI compatible, and it comprises: a controller; One extension lead, the outer surface of this extension lead covers conductive shielding layer; One electrode cable, the outer surface of this electrode cable covers conductive shielding layer; One connecting pin, described connecting pin is for connecting this extension lead and electrode cable thus forming a junction position; And a bindiny mechanism, this bindiny mechanism electric good conductor material with biocompatibility is made, being formed with the conductive shielding layer on electrode cable for making extension lead and be electrically connected, guaranteeing that screen layer has good inhibition to stimulating the RF pyrogenicity temperature rise at contact place.

Description

A kind of split implantable medical devices of MRI compatible
Technical field
This utility model relates to implantable medical devices field, particularly relates to a kind of bindiny mechanism and method of attachment of screen layer of implantable medical devices of MRI compatible, and adopts the implantable medical devices of MRI compatible of this bindiny mechanism.
Background technology
Mr imaging technique (Magnetic Resonance Imaging, MRI) compared with other imaging techniques (as X-ray, CT etc.), there is more significant advantage: nuclear magnetic resonance is more clear, very high resolving power is had to soft tissue, and to human body without ionization radiation injury.So mr imaging technique is widely used among the clinical diagnosis of modern medicine.According to estimates, nowadays the whole world has at least 6,000 ten thousand cases to utilize nmr imaging technique inspection every year.
Have three magnetic fields during MRI work to play a role.The homogeneous static magnetic field B0 of a high strength, a gradient magnetic that can be adjusted to any direction, and for radio frequency (RF) magnetic field of excited nucleus magnetic resonance.That wherein the intensity of magnetostatic field B0 is common is 1.5T and 3.0T, and magnetostatic field B0 and gradient magnetic collaborative work are to provide the spatial positional information of magnetic resonance signal; And radio-frequency (RF) magnetic field is high-power, a high-frequency time-varying magnetic field, its frequency is Larmor frequency, i.e. f=γ B0, wherein γ=42.5MHz/T.So be in the MRI of 1.5T or 3.0T at common magnetostatic field B0, the frequency of radio-frequency (RF) magnetic field is about 64MHz and 128MHz respectively.
Although MRI can not have direct injury to human body, but if implantable medical devices (Implantable Medical Device is installed in patient body, IMD), such as: cardiac pacemaker, defibrillator, vagus nerve stimulator, spinal stimulator, lesions located in deep brain device etc., so, during MRI work, three magnetic fields of required use bring safely very large hidden danger just can to the life and health of patient.Wherein a most important hidden danger is that implantable medical devices is at radio frequency (Radio Frequency, RF) the induction heating in magnetic field, particularly for those with elongated conductive structures, and this elongated conductive structures can the medical apparatus and instruments (typically such as lesions located in deep brain device is with extension lead and electrode cable, and cardiac pacemaker is with electrode wires) of part and contact tissue.When carrying out MRI scanning, may there is serious temperature rise at the position of elongated conductive structures and contact tissue built with the patient of these implantable medical devices in body, such temperature rise can cause serious injury patient.But major part implants the patient of IMD to be needed to carry out MRI inspection within the instrument life cycle, and radio-frequency (RF) magnetic field is responded to the potential safety hazard brought and is caused this part patient to be rejected checking.So, the MRI compatibility function meaning of exploitation implantable medical devices is remarkable, and be mainly reflected in elongated conductive structures as on electrode due to the induction heating effect of radio-frequency (RF) magnetic field, so exploitation can will cause the electrode of serious temperature rise to have very high market value and using value due to the induction heating effect of radio-frequency (RF) magnetic field under MRI environment.
In order to overcome the problems referred to above, prior art arranges conductive shielding layer at the wire outer surface of the implantable medical devices of MRI compatible.But for facilitating operation, the reason ensureing each side such as reliability, existing implantable medical devices often adopts split-type structural, that is, electrode cable wire being divided into the extension lead be connected with controller and being connected with stimulating electrode contact.Just this extension lead and electrode cable can be linked together in operation process.But with existing technology, in extension lead and electrode cable connection procedure, the conductive shielding layer being covered in extension lead outer surface cannot directly realize being electrically connected with between the conductive shielding layer being covered in electrode cable outer surface.Because conductive shielding layer greatly to depend on the integrity of screen layer to the rejection ability of RF thermal effect, that is, must electrical connection be formed between the conductive shielding layer of various piece, conductive shielding layer just can be made effectively to play inhibitory action to RF thermal effect.Therefore, prior art cannot play inhibitory action to RF thermal effect effectively at the implantable medical devices of MRI compatible.
Utility model content
In view of this, the necessary implantable medical devices that a kind of MRI compatible that extension lead can be connected with the screen layer of electrode cable is provided.
A split implantable medical devices for MRI compatible, it comprises: a controller; One extension lead, the outer surface of described extension lead is coated with conductive shielding layer; One electrode cable, the outer surface of described electrode cable is coated with conductive shielding layer; One connecting pin, described connecting pin is for connecting this extension lead and electrode cable thus forming a junction position; And a bindiny mechanism, described bindiny mechanism comprises the sleeve that conductive material that an employing has biocompatibility is made, and this sleeve is used for the conductive shielding layer of the conductive shielding layer of described extension lead outer surface with described electrode cable outer surface to be electrically connected.
Compared with prior art, the bindiny mechanism that this utility model provides, can be connected extension lead with the conductive shielding layer on electrode cable, guarantees that screen layer has good inhibition to stimulating the RF pyrogenicity temperature rise at contact place.
Accompanying drawing explanation
Before the implanted lesions located in deep brain device of the MRI compatible that Fig. 1-3 provides for this utility model first embodiment connects be connected after structural representation.
The structure change of the implanted lesions located in deep brain device of the MRI compatible that Fig. 4-6 provides for this utility model first embodiment.
The schematic diagram of another initiating structure of the bindiny mechanism of the implanted lesions located in deep brain device of the MRI compatible that Fig. 7 provides for this utility model first embodiment.
The preparation method flow chart of the netted sleeve of the bindiny mechanism of the implanted lesions located in deep brain device of the MRI compatible that Fig. 8 provides for this utility model first embodiment.
The structural representation of the difform braiding mould that Fig. 9 adopts when being and preparing netted sleeve in Fig. 8.
The cross sectional representation of the dead ring of the bindiny mechanism of the implanted lesions located in deep brain device of the MRI compatible that Figure 10-11 provides for this utility model first embodiment.
The preparation method flow chart of the dead ring of the bindiny mechanism of the implanted lesions located in deep brain device of the MRI compatible that Figure 12 provides for this utility model first embodiment.
The method of attachment flow chart of the implanted lesions located in deep brain device of the MRI compatible that Figure 13 provides for this utility model first embodiment.
Structural representation before the implanted lesions located in deep brain device connection of the MRI compatible that Figure 14 provides for this utility model second embodiment.
The method of attachment flow chart of the implanted lesions located in deep brain device of the MRI compatible that Figure 15 provides for this utility model second embodiment.
Structural representation before the implanted lesions located in deep brain device connection of the MRI compatible that Figure 16 provides for this utility model the 3rd embodiment.
Structural representation before the implanted lesions located in deep brain device connection of the MRI compatible that Figure 17 provides for this utility model the 4th embodiment.
Structural representation before the implanted lesions located in deep brain device connection of the MRI compatible that Figure 18 provides for this utility model the 5th embodiment.
Structural representation before the implanted lesions located in deep brain device connection of the MRI compatible that Figure 19 provides for this utility model the 6th embodiment.
The application of the implanted lesions located in deep brain device of the MRI compatible that Figure 20 this utility model embodiment provides and principle schematic.
Main element symbol description
Implanted lesions located in deep brain device 10,10A, 10B, 10C, 10D, 10E
Controller 12 sleeve 180
Extension lead 14 mesh shields layer 181
Flexible multi-cavity insulated conduit 140 first barrel 1802
Conductive shielding layer 146,166 second barrel 1804
Connecting pin 15 the 3rd barrel 1806
Socket 150 securing member 182
Electrode cable 16 thin cylinder 183,185
Flexible insulation conduit 160 connecting portion 19
Adapter 142,162 shape-memory alloy fibers 20
Electrode contacts 164 mould 30,32
Bindiny mechanism 18 heating furnace 40,42
Following detailed description of the invention will further illustrate this utility model in conjunction with above-mentioned accompanying drawing.
Detailed description of the invention
The implantable medical devices of the MRI compatible that this utility model provides can be cardiac pacemaker, defibrillator, lesions located in deep brain device, spinal stimulator, vagus nerve stimulator, the intestines and stomach stimulator or other similar implantable medical devices.This utility model is only described for lesions located in deep brain device.
The implantable medical devices of the MRI compatible that this utility model provides is split-type structural, and the outer surface of extension lead and electrode cable is all coated with conductive shielding layer.To be employing one bindiny mechanism link into an integrated entity the conductive shielding layer that the outer surface of this extension lead and electrode cable covers the purpose of this utility model, guarantees that screen layer has good inhibition to stimulating the RF pyrogenicity temperature rise at contact place.Further, this utility model provides various different bindiny mechanism and method of attachment, makes the installation of above-mentioned bindiny mechanism simple and quick, connects reliable, and is more practically applicable to implant surgery process.
Described bindiny mechanism comprises a sleeve.Described sleeve adopts conductive material to make, and this sleeve contraction distortion can become a tubular structure consistent with the external surface shape of the connecting portion of described extension lead and electrode cable.Preferably, described sleeve itself adopts the conductive material with biocompatibility to make.The described conductive material with biocompatibility be have biocompatibility metal material, have biocompatibility carbon-based material and have in the conducting high polymers thing of biocompatibility one or more.The described metal material with biocompatibility is the one or many in platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, rustless steel, Nitinol and cobalt-base alloys.Be appreciated that if the conductive material of this sleeve does not have biocompatibility, then need other protective material in bindiny mechanism's outer setting with biocompatibility.For ease of producing larger distortion easily in operation process, described sleeve can be designed to netted, helical form, the caged that include but not limited to, or the structure such as tubular film.Be appreciated that described bindiny mechanism also can comprise a conductive film or wire, during use, this conductive film or wire be wound around or be wrapped in connecting portion outer surface thus form a sleeve.
Further, described bindiny mechanism can also comprise the securing member for this sleeve being firmly secured to this connecting portion.When using bindiny mechanism provided by the utility model to connect, after treating described sleeve collapses to final structure, described two securing members are enclosed within respectively the end of the final structure of described sleeve.Described securing member can produce certain normal pressure around to the final structure of the described sleeve be placed in ring, thus is firmly secured to outside this connecting portion by this sleeve.Preferably, described securing member adopts the material with biocompatibility to make, the described material with biocompatibility includes but not limited to that the metal material with biocompatibility is as platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, rustless steel, Nitinol or cobalt-base alloys etc., and has the carbon-based material or high molecular polymer etc. of biocompatibility.Described securing member is not limit the method producing certain normal pressure in the parts be placed in ring around scope, and the method that can adopt includes but not limited to: utilize elastic contractile force, utilize the shape memory effect of shape-memory material and other external force etc.Be appreciated that described securing member is alternate configurations.
Adopt the method for attachment of the implantable medical devices of the MRI compatible of described bindiny mechanism to comprise the following steps: step S10, adopt connecting pin to connect described electrode cable and extension lead thus form a junction position; And step S20, the jacket casing of described bindiny mechanism is located at this connecting portion, and makes described colleting deformation become first barrel, second barrel that with the conductive shielding layer of described extension lead outer surface be electrically connected and three barrel that with the conductive shielding layer of described electrode cable outer surface be electrically connected corresponding with described connecting pin.Further, can also adopt described securing member that this sleeve is firmly secured to this connecting portion.
Below in conjunction with the accompanying drawings and the specific embodiments, to bindiny mechanism and the method for attachment of the screen layer of the implantable medical devices of the MRI compatible that this utility model provides, and the implantable medical devices of the MRI compatible of this bindiny mechanism is adopted to be described in further detail.
Refer to Fig. 1-3, this utility model first embodiment provides a kind of implanted lesions located in deep brain device 10 of MRI compatible, and it comprises: controller 12, extension lead 14, connecting pin 15, one electrode cable 16 and a bindiny mechanism 18.One end of described extension lead 14 is electrically connected with described controller 12, and the other end is used for being electrically connected with described electrode cable 16.One end of described electrode cable 16 is used for being electrically connected with described extension lead 14, and the other end is used for providing electrical stimulation signal to organism.Described connecting pin 15 is for connecting described extension lead 14 and electrode cable 16.The outer surface of described extension lead 14 and electrode cable 16 is all coated with conductive shielding layer.After described extension lead 14 and electrode cable 16 are electrically connected by described connecting pin 15, described bindiny mechanism 18 for being electrically connected by the conductive shielding layer of described extension lead 14 and electrode cable 16 outer surface, thus effectively suppresses the RF pyrogenicity temperature rise at the electrode contacts place of the implanted lesions located in deep brain device 10 of this MRI compatible under MRI scanning circumstance.
Described electrode cable 16 comprises: a flexible insulation conduit 160, and this flexible insulation conduit 160 has a first end and second end relative with this first end; At least one adapter 162 is arranged at the outer surface of the first end of this flexible insulation conduit 160; At least one electrode contacts 164 is arranged at the outer surface of the second end of this flexible insulation conduit 160; And one spiral conducting line (not shown) to be arranged at this flexible insulation conduit 160 inner, and described at least one electrode contacts 164 and at least one adapter 162 are electrically connected by this spiral conducting line.
Described flexible insulation conduit 160 mainly rises and supports this at least one adapter 162 and at least one electrode contacts 164, and protects the effect of this spiral conducting line and exterior insulation.The length of described flexible insulation conduit 160, internal diameter and external diameter are not limit, can according to clinical treatment need select.Described flexible insulation conduit 160 is made up of one or more materials in polyurethane material, silastic material and nylon material.The outer surface of described flexible insulation conduit 160 is coated with conductive shielding layer.Described conductive shielding layer adopts the metal material with biocompatibility, has conducting high polymers thing or the conductive carbon material preparation of biocompatibility.In the present embodiment, described flexible insulation conduit 160 is a cylindrical polyurethane tube, and this flexible insulation conduit 160 is an enclosed construction near the end of at least one electrode contacts 164.The outer surface of described flexible insulation conduit 160 is coated with the conductive shielding layer that rustless steel is made.
Described at least one adapter 162 is for being electrically connected this spiral conducting line with described extension lead 14.When described at least one electrode contacts 164 uses in implantable bioartificial body, for applying electricity irritation to organism.Being made up of the electric good conductor material with biocompatibility of described at least one adapter 162 and at least one electrode contacts 164.Preferably, the described electric good conductor material with biocompatibility for having the metal material of biocompatibility, can have the conducting high polymers thing of biocompatibility, one or more in CNT and carbon nano tube compound material.Quantity and the size of described at least one adapter 162 and at least one electrode contacts 164 are not limit, and can select as required.In the present embodiment, four adapters 162 and four electrode contacts 164 are arranged at intervals at the two ends of this flexible insulation conduit 160 respectively, and by the electrical connection of four-wire type spiral conducting line one_to_one corresponding.Each adapter 162 or electrode contacts 164 are ring-type and around the outer surface being coated on this flexible insulation conduit 160.
Described spiral conducting line comprises the insulating polymer material coating that an electric wire and with biocompatibility is arranged at this electric wire outer surface.The macromolecular material of described coating can be one or more in polyurethane, silicone rubber, nylon, fluoro-containing plastic (as PTFE, ETFE etc.), Pai Lalun and polyimides.Described coating can be the multiple structure formed by the monolayer of single type material or multiple material.Preferably, the electric wire of described spiral conducting line is made up of the electric good conductor material with biocompatibility, for transmitting the signal of telecommunication between described at least one adapter 162 and at least one electrode contacts 164.Number of conductors and the number of turn of described spiral conducting line are not limit, and can select as required.In the present embodiment, described spiral conducting line is four-wire type structure, has four wires, and a connector 162 is electrically connected with corresponding electrode contacts 164 by every bar wire.
Described controller 12 is for receiving the signal of telecommunication that imports into from described electrode cable 16 or to described electrode output voltage or electric current.The structure of described controller 12 and type can carry out designing and selecting according to the purposes of implantable medical devices.
Described extension lead 14 is drawn together a flexible multi-cavity insulated conduit 140 and and is arranged at spiral conducting line (not shown) in this flexible multi-cavity insulated conduit 140.Spiral conducting line in described extension lead 14 passes from flexible multi-cavity insulated conduit 140.In the present embodiment, described flexible multi-cavity insulated conduit 140 is four chamber cylinders, makes with silicone rubber, and the outer surface of described flexible multi-cavity insulated conduit 140 is coated with the screen layer that rustless steel is made.The external diameter of described flexible multi-cavity insulated conduit 140 is greater than the external diameter of described flexible insulation conduit 160.
Described connecting pin 15 is arranged at this flexible multi-cavity insulated conduit 140 away from the end of described controller 12 and is electrically connected with this flexible multi-cavity insulated conduit 140.Described connecting pin 15 adopts the material identical with flexible multi-cavity insulated conduit 140 to prepare.In the present embodiment, described flexible multi-cavity insulated conduit 140 and the one-body molded preparation of described connecting pin 15.Described connecting pin 15 has a socket 150, for resettlement section sub-electrode wire 16.The inner surface of described socket 150 is provided with multiple connecting terminal (not shown).One end of the spiral conducting line of described extension lead 14 is electrically connected with described controller 12, and the other end is electrically connected with the multiple connecting terminals in described socket 150.When this socket 150 is inserted in one end of described electrode cable 16, the adapter 162 of described electrode cable 16 contacts with the multiple connecting terminal one_to_one corresponding in described socket 150, thus makes this electrode cable 16 fix with described extension lead 14 and realize being electrically connected.Be appreciated that part extension lead 14 and the partial electrode wire 16 of described connecting pin 15 and this connecting pin 15 close form a junction position 19 jointly.In the present embodiment, described connecting pin 15 is cylindrical, and adopts silicone rubber preparation.The external diameter of described connecting pin 15 is greater than the external diameter of described flexible multi-cavity insulated conduit 140.Described socket 150 is cylindrical, and diameter equals described electrode cable 16 external diameter.
Be appreciated that except scheme as shown in Figure 1, as shown in Figure 4, described connecting pin 15 also can with the described one-body molded preparation of flexible insulation conduit 160; Described connecting pin 15 simultaneously has a socket 150, for accommodating part extension lead 14, and arranges multiple connecting terminal at described socket 150 inner surface.At extension lead 14, multiple adapter 142 is set away from one end of described controller 12, when this socket 150 is inserted in one end of described extension lead 14, the adapter 142 of described extension lead 14 contacts with the multiple connecting terminal one_to_one corresponding in described socket 150, thus makes this electrode cable 16 fix with described extension lead 14 and realize being electrically connected.
Except above-mentioned two schemes, as shown in Figure 5, also can connecting pin 15 be independently set, makes described connecting pin two ends that socket 150 is all set, be respectively used to collecting part extension lead 14 and partial electrode wire 16.Multiple connecting terminal is set at described socket 150 inner surface, the connecting terminal one_to_one corresponding respectively of two socket 150 inner surfacies, and connects with wire.Arrange multiple adapter 142 in one end of extension lead 14, when described socket 150 is inserted in one end of described extension lead 14, described adapter 142 contacts with the multiple connecting terminal one_to_one corresponding in described socket 150; Arrange multiple adapter 162 in one end of electrode cable 16, when another socket 150 is inserted in one end of described electrode cable 16, described adapter 162 contacts with the multiple connecting terminal one_to_one corresponding in described socket 150; Thus make this electrode cable 16 fix with described extension lead 14 and realize being electrically connected.
Be appreciated that, as shown in Figure 6, described extension lead 14, the part that connecting pin 15 and described electrode cable 16 are exposed at outside this connecting pin 15 also can have identical external diameter, and the external diameter that just this electrode cable 16 inserts the part of this connecting pin 15 is less than the external diameter of other parts.After this electrode cable 16 inserts described connecting pin 15 realization connection, the implantable medical devices of described MRI compatible has homogeneous external diameter.
Described bindiny mechanism 18 comprises a sleeve 180 and two securing members 182.Described sleeve 180 and two securing members 182 all adopt the shape-memory material with biocompatibility to make.The described conductive shapes memory material with biocompatibility includes but not limited to titanium nickel (TiNi) marmem, shape memory conducting high polymers thing etc.
Described sleeve 180 through shape memory heat treatment, make this sleeve 180 be heated reach transition temperature time can contraction distortion to become be a tubular structure consistent with connecting portion 19 external surface shape of described implanted lesions located in deep brain device 10.Described transition temperature can be determined as required.Preferably, transition temperature should between 45 DEG C ~ 90 DEG C.Be appreciated that transition temperature should be not less than 45 DEG C in order to ensure that namely described sleeve 180 does not shrink distortion near body temperature, for ensureing that described transition temperature can reach with comparalive ease in operation process, transition temperature should not higher than 90 DEG C.
Preferably, described sleeve 180 is a netted airtight tubular structure, has good pliability and anti-fatigue performance and larger deformation to make this sleeve 180.Preferably, described sleeve 180 is a monolayer network structure, and its fibrage adopting the conductive material with biocompatibility to make forms.Described weaving method can be monofilament braiding or doubling braiding.Preferably, the diameter of the fiber that the described marmem with biocompatibility is made should be more than or equal to 0.02 millimeter and be less than or equal to 0.2 millimeter.Be appreciated that, for ensureing that described netted sleeve 180 has enough intensity and electric conductivity, the diameter of fiber should be more than or equal to 0.02 millimeter, and for ensureing that described netted sleeve 180 has good pliability and anti-fatigue performance, the diameter of fiber should be less than or equal to 0.2 millimeter.The length of described sleeve 180 is greater than the length of described connecting pin 15.
For convenience of description and understand, it is initiating structure that this utility model description defines the structure of described sleeve 180 before contraction distortion, define described sleeve 180 at the transition temperature can free shrink distortion formed structure be memory structures.Described initiating structure and memory structures refer to the shape and size of described sleeve 180.Length after the contraction distortion of described sleeve 180 and shape of cross section substantially constant, but cross sectional dimensions obviously diminishes.See Fig. 2, the memory structures of described sleeve 180 after contraction distortion all have identical with the shape of cross section of described connecting pin 15 first barrel 1802, identical with the shape of cross section of described extension lead 14 second barrel 1804 and three barrel 1806 identical with the shape of cross section of described electrode cable 16.Described second barrel 1804 contacts with the conductive shielding layer of described extension lead 14 outer surface, and described 3rd barrel 1806 contacts with the conductive shielding layer of described electrode cable 16 outer surface, thus the conductive shielding layer of described extension lead 14 outer surface is electrically connected by the sleeve 180 after described contraction distortion with the conductive shielding layer of described electrode cable 16 outer surface.Be appreciated that the diameter of described first barrel 1802, second barrel 1804 and the 3rd barrel 1806 is all identical with cross section when adopting the structure shown in Fig. 6.
Preferably, the internal diameter size of the memory structures of described sleeve 180 should be less than or equal to the outside dimension with described connecting portion 19 correspondence position.Be appreciated that, when the internal diameter size of the memory structures that described sleeve 180 reaches through shape memory effect is less than the outside dimension with the correspondence position of described connecting portion 19, due to the supporting role of connecting portion 19, final structure after the contraction distortion of described sleeve 180 is the practical structures after the support force of described sleeve 180 contractility at the transition temperature and connecting portion 19 reaches balance, therefore, the size of the final structure of described sleeve 180 will be greater than the size of memory structures.Like this, described sleeve 180 is closely fitted in intensity larger connecting portion 19 surface, can obtain stable shape.Preferably, the cross-sectional area S1 of each barrel of the memory structures of described sleeve 180 is less than the cross-sectional area S2 of the connecting portion 19 of its correspondence, and meet relation: (S2-S1)/S2≤10%, with the intimate laminating of connecting portion 19 that each barrel of the practical structures of covering after sleeve 180 contraction distortion described in guaranteeing can be corresponding with it.When the internal diameter size of the memory structures of described sleeve 180 equals the outside dimension with the correspondence position of described connecting portion 19, the final structure of described sleeve 180 and memory structures.
Be appreciated that the shape of cross section of the initiating structure of described sleeve 180 is not limit, can select as required.As shown in Figure 1, described sleeve 180 initiating structure can have homogeneous internal diameter.Preferably, this internal diameter should be more than or equal to the maximum outside diameter of described connecting portion 19, so that easily preparation and sheathed.Preferably, the shape of cross section of the initiating structure of described sleeve 180 is identical with the shape of cross section of described connecting pin 15, and the internal diameter of initiating structure is greater than the external diameter of described connecting pin 15.More preferably, the cross-sectional area S4 of the cross-sectional area S3 and described connecting pin 15 that cover the initiating structure of sleeve 180 described in meets relation: (S3-S4)/S4≤10%.As shown in Figure 7, described sleeve 180 initiating structure also can have inhomogenous internal diameter.Such as, the initiating structure part internal diameter of described sleeve 180 is less than other parts, thus forms three barrel 1806 identical with the shape of cross section of described electrode cable 16.During use, first the 3rd barrel 1806 is sheathed on described electrode cable 16, then wait one end of described electrode cable 16 is inserted into described connecting pin 15 socket 150 in after, again this sleeve 180 movable sleeving is located at connecting portion 19, finally heating makes these sleeve 180 other parts shrink deformation.
Refer to Fig. 8, this utility model first embodiment provides the preparation method of the netted sleeve 180 of a kind of above-mentioned shape memory further.The method comprises the following steps:
Step S10A: be a mesh shields layer 181 at braiding mould 30 surface weave consistent with connecting portion 19 shape by the shape-memory alloy fibers 20 with biocompatibility;
Step S20A: the mesh shields layer 181 and described braiding mould 30 entirety that have woven are carried out shape memory heat treatment, with the memory making this mesh shields layer 181 obtain the shape to described braiding mould 30; And
Step S30A: this mesh shields layer 181 is taken off from described braiding mould 30, and its internal diameter is expanded, thus obtain the sleeve 180 that has memory structures.
In described step S10A, special braiding apparatus is used to weave.Weaving method can be monofilament braiding or doubling braiding.For ensureing that described netted sleeve 181 has enough intensity and electric conductivity, the diameter of fiber 20 should be more than or equal to 0.02 millimeter, for ensureing that described netted sleeve 181 has good pliability and anti-fatigue performance, the diameter of fiber 20 should be less than or equal to 0.2 millimeter.See Fig. 9, the shape of described braiding mould 30 can be selected according to the shape of the nerve stimulator link of different model.
In described step S20A, the mesh shields layer 181 and described braiding mould 30 entirety that have woven are put into a heating furnace 40 and carries out shape memory heat treatment.Described shape memory Principles of Heating Processing, for marmem is heated to more than transformation temperature, make it be converted into parent phase (austenite) completely.Will through the marmem part rapid quench of heating, then parent phase can be subject to quenching vacancy and interaction of dislocation and strengthen.The temperature of heating is higher, and Parent phase strengthening is also more remarkable, and the rate of cooling of quenching is faster, also can strengthen the strengthening to parent phase.General needs select different heating-up temperatures and hardening media according to different shape-memory materials.
In described step S30A, this sleeve 180 can be made to have uniform internal diameter after mesh shields layer 181 internal diameter is expanded, also can have uneven internal diameter.
Described securing member 182 for sleeve 180 being firmly fixed on the outer surface of connecting portion 19, and makes this sleeve 180 reliably be electrically connected with the conductive shielding layer of described extension lead 14 and electrode cable 16 outer surface.As mentioned before, in order to ensure that described netted sleeve 180 has good pliability and anti-fatigue performance, the diameter making the fiber of described netted sleeve 180 should be less than or equal to 0.2 millimeter.Be appreciated that its contractility is difficult to ensure to form reliable electrical connection at described netted sleeve 180 with the contact position of the conductive shielding layer of described extension lead 14 outer surface and the conductive shielding layer of described electrode cable 16 outer surface because fiber is comparatively thin.Described securing member 182 can produce certain normal pressure around to the parts be placed in ring, when using bindiny mechanism 18 provided by the utility model to connect, after treating that described sleeve 180 is contracted to final structure, described two securing members 182 are enclosed within respectively the second barrel 1804 of the final structure of described sleeve 180 and the outer surface of the 3rd barrel 1806.Described second barrel 1804 and the 3rd barrel 1806 firmly can be fixed on the conductive shielding layer of described extension lead 14 and electrode cable 16 outer surface by described pressure.
In the present embodiment, described securing member 182 utilizes the shape memory effect of shape-memory material to produce certain normal pressure to the normal direction within the scope of the parts be placed in ring around 360 °, for the ease of understanding and describing, in this description, this securing member 182 is defined as shape memory securing member 182.The structure that can realize shape memory securing member 182 includes but not limited to closed circular structure as shown in Figure 10 or non-close circulus as shown in figure 11.When described securing member 182 closed circular structure, the pressure that it can be certain to the generation within the scope of the parts be placed in ring around 360 °.Shape of cross section and the size of described shape memory securing member 182 are not limit, and can determine according to the cross section of supporting extension lead 14 and electrode cable 16.Described securing member 182 is dead ring, and its cross section can be circle, rectangle, hexagon or other polygons.
Utilize the shape memory effect of shape-memory material to produce normal pressure if be appreciated that, then described shape memory securing member 182 must be made with the shape-memory material with biocompatibility.The described shape-memory material with biocompatibility includes but not limited to titanium nickel (TiNi) marmem, shape memory conducting high polymers thing etc.Described shape memory securing member 182, through shape memory heat treatment, makes this shape memory securing member 182 shrink when being heated and reaching transition temperature, produces certain normal pressure to the normal direction within the scope of the parts be placed in ring around 360 °.Described transition temperature can be determined as required.Preferably, transition temperature should between 45 DEG C ~ 90 DEG C.Be appreciated that, for ensureing that namely described shape memory securing member 182 does not shrink distortion near body temperature, transition temperature should be not less than 45 DEG C, and for ensureing that described transition temperature can reach with comparalive ease in operation process, transition temperature should not higher than 90 DEG C.
When using bindiny mechanism 18 provided by the utility model to connect, after treating that described sleeve 180 is contracted to final structure, described two shape memory securing members 182 are enclosed within respectively the second barrel 1804 of the final structure of described sleeve 180 and the outer surface of the 3rd barrel 1806, and heating makes described two shape memory securing members 182 because of shape memory function contraction, thus described second barrel 1804 and the 3rd barrel 1806 are firmly fixed on the screen layer of described extension lead 14 and electrode cable 16 outer surface.
For convenience of description and understand, it is initiating structure that this utility model description defines the structure of described shape memory securing member 182 before contraction distortion, define described shape memory securing member 182 at the transition temperature contraction distortion formed structure be memory structures.Described initiating structure and memory structures refer to the shape and size of described securing member 182.Length after the contraction distortion of described shape memory securing member 182 and shape of cross section substantially constant, but cross sectional dimensions obviously diminishes.The length of described shape memory securing member 182 is defined as this shape memory securing member 182 at the yardstick along the direction with cross-section normal.The girth of the initiating structure of described shape memory securing member 182 is 3.5 millimeters ~ 15 millimeters.The internal diameter size of the initiating structure of described shape memory securing member 182 is greater than the second corresponding barrel 1804 or the external diameter of the 3rd barrel 1806, thus makes easily sheathed.The internal diameter size of the memory structures of described shape memory securing member 182 is less than or equal to the second corresponding barrel 1804 or the external diameter of the 3rd barrel 1806, thus the second barrel 1804 of correspondence or the 3rd barrel 1806 firmly can be fixed to the surface of extension lead 14 or electrode cable 16 by the shape memory securing member 182 after making contraction distortion.When the internal diameter size of the memory structures of described shape memory securing member 182 is less than the external diameter of the second corresponding barrel 1804 or the 3rd barrel 1806, due to the supporting role of connecting portion 19, support force for described securing member 182 contractility at the transition temperature and connecting portion 19 is reached the practical structures after balance by the final structure of described shape memory securing member 182, therefore, the size of the final structure of described shape memory securing member 182 will be greater than the size of memory structures.Preferably, the cross-sectional area S5 of the memory structures of described shape memory securing member 182 is less than the second barrel 1804 of its correspondence or the cross-sectional area S6 of the 3rd barrel 1806, and meet relation: (S6-S5)/S6≤10%, with guarantee practical structures after the contraction distortion of described shape memory securing member 182 can be corresponding with it the second barrel 1804 or the 3rd barrel 1806 fit tightly.When the internal diameter size of the memory structures of described shape memory securing member 182 equals the external diameter of the second corresponding barrel 1804 and the 3rd barrel 1806, the final structure of described shape memory securing member 182 and memory structures.
In this utility model embodiment, described bindiny mechanism 18 comprises a sleeve 180 and two securing members 182.The initiating structure of described sleeve 180 is the homogeneous cylinder of internal diameter, and memory structures comprise one first cylinder and are positioned at these the first cylinder two ends and the second cylinder be communicated with this first cylinder and the 3rd cylinder.The diameter of described second cylinder and the 3rd cylinder is less than the diameter of this first cylinder.The internal diameter of described first cylinder equals the outer warp of described connecting pin 15.Described second cylinder and the 3rd barrel bore equal the outer warp of described extension lead 14 and electrode cable 16 respectively.The shape memory effect utilizing elastic contractile force, utilize shape-memory material of described two securing members 182 produces certain normal pressure to the normal direction within the scope of the parts be placed in ring around 360 °, described second barrel 1804 and the 3rd barrel 1806 is firmly fixed on the screen layer of described extension lead 14 and electrode cable 16 outer surface.
Refer to Figure 12, this utility model first embodiment provides a kind of preparation method of above-mentioned shape memory securing member 182 further.The method comprises the following steps:
Step S10B: utilize processing mold 32 to process internal diameter than extension lead 14 or the smaller shape memory securing member 182 of electrode cable 16 external diameter;
Step S20B: marmem securing member 182 is carried out shape memory heat treatment together with mould 32, after heat treatment completes, this securing member 182 just obtains the shape memory of right mould 32;
Step S30B: dead ring is taken off from mould 32, and its internal diameter is expanded.
In described step S10B, described mould 32 has the uniform taper end of a diameter and the gradually thicker butt end corresponding with this taper end.Described securing member 182 is formed with in this taper end.The shape of described mould 32 can be selected according to the shape of described extension lead 14 or electrode cable 16.
In described step S20B, this marmem securing member 182 is put into a heating furnace 42 with mould 32 entirety and carries out shape memory heat treatment.
In described step S30B, shape memory securing member 182 is pushed to the butt end of mould 32, the internal diameter of shape memory securing member 182 is expanded, then takes off from mould 32.
Refer to Figure 13, this utility model first embodiment provides a kind of further and adopts above-mentioned bindiny mechanism 18 by the method for the conductive shielding layer of described extension lead 14 and electrode cable 16 outer surface electrical connection.The method comprises the following steps:
Step S10C: form a junction position 19 in the socket 150 one end of described electrode cable 16 being inserted described connecting pin 15;
Step S20C: described sleeve 180 is sheathed on this connecting portion 19;
Step S30C: heat the second barrel 1804 and the 3rd barrel 1806 be electrically connected with the conductive shielding layer of described electrode cable 16 outer surface that described sleeve 180 makes its contraction distortion become first barrel 1802, corresponding with described connecting pin 15 to be electrically connected with the conductive shielding layer of described extension lead 14 outer surface;
Step S40C: the first securing member 182 is sheathed in this second barrel 1804, and the second securing member 182 is sheathed in the 3rd barrel 1806; And
Step S50C: heat described first securing member 182 and the second securing member 182, make this first securing member 182 contraction distortion and fit with the intimate of this second barrel 1804, and make this second securing member 182 contraction distortion and fit with the intimate of the 3rd barrel 1806.
In described step S10C, one end that described electrode cable 16 has adapter 162 is inserted in the socket 150 of described connecting pin 15, and this adapter 162 contacts with the connecting terminal one_to_one corresponding in socket 150 and is electrically connected.
In described step S20C, after described sleeve 180 is sheathed on this connecting portion 19, described connecting pin 15 is placed in described sleeve 180 completely.Be appreciated that before described sleeve 180 is sheathed on this connecting portion 19, a diaphragm seal first can also be adopted to cover this connecting portion 19, infiltrate in this connecting portion 19 to prevent liquid and cause short circuit.
In described step S30C, the mode heating described sleeve 180 is not limit, as long as guarantee that this sleeve 180 can thermally equivalent, the heating means that can adopt include but not limited to: hot-water soak, hot blast are blown, use Portable heating device to heat etc.Described heating-up temperature is 45 DEG C ~ 90 DEG C.The contraction distortion because of shape memory function of described sleeve 180, covers connecting portion 19 surface equably, and is formed with the screen layer on extension lead 14 and electrode cable 16 surface respectively at two ends and overlap.
In described step S40C, be appreciated that described first securing member 182 first can be sheathed on this extension lead 14 before step S10, by the time during step S40, move in this second barrel 1804.
In described step S50C, the mode heating described dead ring 182 is not limit, as long as guarantee that this dead ring 182 can evenly penetrate heat.Described heating-up temperature is 45 DEG C ~ 90 DEG C.
Be appreciated that described step S40C and S50C is optional step.In described step S40C and S50C, also can only sheathed and shrink a securing member 182.If bindiny mechanism 18 only comprises plural securing member 182, then can be once all sheathed and make its contraction distortion; Or repeatedly sheathed and contraction distortion.
Refer to Figure 14, this utility model second embodiment provides a kind of implanted lesions located in deep brain device 10A of MRI compatible, and it comprises: controller 12, extension lead 14, connecting pin 15, one electrode cable 16 and a bindiny mechanism 18.
The structure of the implanted lesions located in deep brain device 10 of the MRI compatible that the implanted lesions located in deep brain device 10A of the MRI compatible that this utility model second embodiment provides provides with this utility model first embodiment is substantially identical, its difference is, the sleeve 180 of described bindiny mechanism 18 is helical form, and adopts the conductive material having the elasticity of biocompatibility good to make.The good conductive material of the described elasticity with biocompatibility includes but not limited to that the metal material with biocompatibility is as platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, rustless steel, Nitinol or cobalt-base alloys etc., and has the carbon-based material or conducting high polymers thing etc. of biocompatibility.
Particularly, in the present embodiment, described sleeve 180 is Reducing screw spring structure.The conductive material having the elasticity of biocompatibility good is adopted to process.Be appreciated that the different parts at screw sheel 180, the wire diameter d of described spring structure can not be unique.Preferably, can at the two ends of screw sheel 180, the wire diameter d of spring structure is suitably strengthened with the conductive shielding layer contact position of extension lead 14 and electrode cable 16, to obtain better elasticity, the contact strength that the conductive shielding layer increasing bindiny mechanism and extension lead 14 and electrode cable 16 contacts.Preferably, the wire diameter d in the middle part of described screw sheel 180 should, more than 1 millimeter, to avoid the external diameter of bindiny mechanism 18 excessive, not be difficult to implant.The length of described screw sheel 180 is greater than the length of described connecting pin 15.
Described screw sheel 180 is the inner surface tubular structure consistent with connecting portion 19 external surface shape of described implanted lesions located in deep brain device 10 in its natural state.As shown in figure 14, described screw sheel 180 all has identical with the shape of cross section of described connecting pin 15 first barrel 1802, identical with the shape of cross section of described extension lead 14 second barrel 1804 and three barrel 1806 identical with the shape of cross section of described electrode cable 16 in its natural state.Described second barrel 1804 contacts with the conductive shielding layer of described extension lead 14 outer surface, and described 3rd barrel 1806 contacts with the conductive shielding layer of described electrode cable 16 outer surface.By screw sheel 180, formed between the conductive shielding layer of described extension lead 14 outer surface and the conductive shielding layer of described electrode cable 16 outer surface and be electrically connected.Be appreciated that the diameter of described first barrel 1802, second barrel 1804 and the 3rd barrel 1806 is all identical with cross section when implanted lesions located in deep brain device adopts structure as shown in Figure 6.
Be appreciated that the shape of cross section of described screw sheel 180 structure in its natural state should be identical with the shape of cross section of described connecting portion 19.Described screw sheel 180 internal diameter size in its natural state should be less than or equal to the outside dimension of correspondence position on described connecting portion 19.When the internal diameter size of described screw sheel 180 structure is in its natural state less than the outside dimension with the correspondence position of described connecting portion 19, due to the supporting role of connecting portion 19, the final structure being arranged on the screw sheel 180 on connecting portion 19 is the practical structures after the elastic contractile force of described screw sheel 180 and the support force of connecting portion 19 reach balance, therefore, the size that will be greater than under naturalness of the size of the final structure of described screw sheel 180.Preferably, the cross-sectional area S7 of each barrel of described screw sheel 180 structure is in its natural state less than the cross-sectional area S8 of the connecting portion 19 of its correspondence, and meet relation: (S8-S7)/S8≤10%, with each barrel of the practical structures guaranteeing described screw sheel 180 can be corresponding with it connecting portion 19 intimate laminating.When the internal diameter size of described sleeve 180 structure in its natural state equals the outside dimension with the correspondence position of described connecting portion 19, the structure under the final structure of described screw sheel 180 and naturalness.
Be appreciated that before use, be necessary the structure of constraint helical casing cylinder 180.Screw sheel 180 after this constraint is before contraction distortion is final structure, and the minimum place of its internal diameter should be more than or equal to the maximum outside diameter of described connecting portion 19, so that sheathed.For convenience of description and understand, this description defines the structure of described screw sheel 180 under being tied, shape and size are restraining structure.Preferably, the restraining structure of described screw sheel 180 has homogeneous internal diameter, and the shape of cross section of its restraining structure is identical with the shape of cross section of described connecting pin 15, and internal diameter is greater than the external diameter of described connecting pin 15.
The mode of the restraining structure of the screw sheel 180 described in maintenance is not limit, as long as guarantee described screw sheel 180 stable maintenance restraining structure, and can constraint relief easily in operation process.In this utility model embodiment, as shown in figure 15, before surgery, screw sheel 180 struts by the thin cylinder 183 first adopting a length to be greater than screw sheel 180.When performing the operation, described screw sheel 180 is sheathed on described connecting portion 19 together with described thin cylinder 183; Described thin cylinder 183 is extracted out from screw sheel 180, then described screw sheel 180 just can fit tightly the surface in connecting portion 19 due to elastic shrinkage, and contacts with the conductive shielding layer of described electrode cable 16 outer surface and formed with the conductive shielding layer of described extension lead 14 outer surface at two ends respectively and be electrically connected.
Described bindiny mechanism 18 comprises two securing members 182 further.The securing member 182 of described bindiny mechanism 18 utilizes elastic contractile force to produce certain normal pressure in direction around to the parts be placed in ring.For the ease of understanding and describing, in this description, this securing member 182 is defined as elastic fastener 182.The structure that can realize elastic fastener 182 includes but not limited to helical spring structure and film cylinder structure.Be appreciated that, in the present embodiment, described elastic fastener 182 should use the good material of the described material Elastic with biocompatibility to make, and includes but not limited to the high molecular polymer etc. that platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, rustless steel, Nitinol, cobalt-base alloys and elasticity are good.The shape of cross section of described elastic fastener 182 structure in its natural state should be identical with the 3rd barrel 1806 shape of cross section with the second barrel 1804 of the final structure of described sleeve 180, and described elastic fastener 182 internal diameter size in its natural state should be less than the second barrel 1804 of the final structure of described sleeve 180 and the outside dimension of the 3rd barrel 1806 cross section.Preferably, described elastic fastener 182 cross-sectional area S9 is in its natural state less than the cross section S0 of the final structure of the described sleeve 180 of its correspondence, and meets relation: (S0-S9)/S9≤10%.Due to the supporting role of the final structure of described sleeve 180, the final structure being arranged on the elastic fastener 182 on connecting portion 19 is the practical structures after the elastic contractile force of described elastic fastener 182 and the support force of connecting portion 19 reach balance, therefore, the size of structure that will be greater than under naturalness of the size of the final structure of described elastic fastener 182.Be appreciated that, due to elastic reaction, elastic fastener 182 produces certain normal pressure by the normal direction within the scope of the parts be placed in ring around 360 °, described second barrel 1804 and the 3rd barrel 1806 is firmly fixed on the screen layer of described extension lead 14 and electrode cable 16 outer surface.
Be appreciated that before use, be necessary the structure retraining elastic fastener 182, before contraction distortion is final structure, its internal diameter should be more than or equal to the outside dimension of described second barrel 1804 and the 3rd barrel 1806 cross section, so that sheathed.For convenience of description and understand, this description defines the structure of described elastic fastener 182 under being tied, shape and size are restraining structure.Preferably, the restraining structure of described elastic fastener 182 has homogeneous internal diameter, and the shape of cross section of its restraining structure is identical with the shape of cross section of described connecting pin 15, and internal diameter is greater than the external diameter of described connecting pin 15.
The mode of the restraining structure of the elastic fastener 182 described in maintenance is not limit, as long as guarantee described elastic fastener 182 stable maintenance restraining structure, and can constraint relief easily in operation process.In this utility model embodiment, as shown in figure 15, before surgery, elastic fastener 182 struts by the thin cylinder 185 adopting a length to be greater than elastic fastener 182.When performing the operation, described elastic fastener 182 is sheathed on described second barrel 1804 and the 3rd barrel 1806 together with described thin cylinder 185; Described thin cylinder 185 is extracted out from sleeve 180, then described elastic fastener 182 just can fit tightly surface in described second barrel 1804 and the 3rd barrel 1806 due to elastic shrinkage, described second barrel 1804 and the 3rd barrel 1806 is firmly fixed on the screen layer of described extension lead 14 and electrode cable 16 outer surface.
Refer to Figure 15, this utility model second embodiment provides a kind of further and adopts above-mentioned bindiny mechanism 18 by the method for the conductive shielding layer of described extension lead 14 and electrode cable 16 outer surface electrical connection.The method comprises the following steps:
Step S10D: form a junction position 19 in the socket 150 one end of described electrode cable 16 being inserted described connecting pin 15;
Step S20D: this screw sheel 180 struts by the thin cylinder 183 adopting a length to be greater than screw sheel 180, and described screw sheel 180 is sheathed on described connecting portion 19 together with described thin cylinder 183;
Step S30D:; Described thin cylinder 183 is extracted out from screw sheel 180, makes described screw sheel 180 be deformed into the second barrel 1804 and the 3rd barrel 1806 be electrically connected with the conductive shielding layer of described electrode cable 16 outer surface that first barrel 1802, corresponding with described connecting pin 15 be electrically connected with the conductive shielding layer of described extension lead 14 outer surface due to elastic shrinkage;
Step S40D: elastic fastener 182 struts by the thin cylinder 185 adopting a length to be greater than elastic fastener 182, and described elastic fastener 182 is sheathed on described second barrel 1804 and the 3rd barrel 1806 respectively together with described thin cylinder 185; And
Step S50D: extracted out from described elastic fastener 182 by described thin cylinder 185, makes described elastic fastener 182 fit tightly the surface in described second barrel 1804 and the 3rd barrel 1806 due to elastic shrinkage.
Be appreciated that described thin cylinder 183 and thin cylinder 185 structure are not limit, as long as the cylindrical body that can support described screw sheel 180 or described elastic fastener 182 is all passable.
Refer to Figure 16, this utility model the 3rd embodiment provides a kind of implanted lesions located in deep brain device 10B of MRI compatible, and it comprises: controller 12, extension lead 14, connecting pin 15, one electrode cable 16 and a bindiny mechanism 18.
The structure of the implanted lesions located in deep brain device 10 of the MRI compatible that the implanted lesions located in deep brain device 10B of the MRI compatible that this utility model the 3rd embodiment provides provides with this utility model first embodiment is substantially identical, its difference is, the sleeve 180 of described bindiny mechanism 18 is caged, the securing member 182 of described bindiny mechanism 18 is helical spring structure, and adopts the conductive material having the elasticity of biocompatibility good to make.The good conductive material of the described elasticity with biocompatibility includes but not limited to that the metal material with biocompatibility is as platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, rustless steel, Nitinol or cobalt-base alloys etc., and has the carbon-based material or conducting high polymers thing etc. of biocompatibility.
Particularly, described caged sleeve 180 multiple bus of comprising two non-close rings be arranged in parallel and being arranged between these two non-close rings.The two ends of the plurality of bus are individually fixed on these two non-close rings.The fixed form adopted is not limit, and the fixed form that can adopt includes but not limited to welding, bonding etc.The plurality of bus and this non-close ring form a cage structure jointly.The opening of these two non-close rings be positioned at be parallel to caged sleeve 180 axis same straight line on, thus make this caged sleeve 180 form the non-close tubular structure of a lateral opening.This caged sleeve 180 from the opening part open and close of non-close ring, thus can be located at connecting portion 19 by described caged sleeve 180.The material that described non-close ring adopts the elasticity with biocompatibility good is made, the good conductive material of the described elasticity with biocompatibility includes but not limited to that the metal material with biocompatibility is as platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, rustless steel, Nitinol or cobalt-base alloys etc., and has the high molecular polymer etc. of biocompatibility.Be appreciated that the material that described non-close ring also can adopt the plasticity with biocompatibility good is made, realize changing opening of caged sleeve 180 and closed by plasticity.Preferably, the string diameter of described non-close ring is not less than 0.5 millimeter, to make it have enough elasticity.When connecting portion 19 is located at by this caged sleeve 180, the outer surface that the two ends of described bus are pressed in the conductive shielding layer of described extension lead 14 outer surface and described electrode cable 16 outer surface by described non-close ring respectively forms electrical connection.
In the present embodiment, described multiple bus can be soft conductive fiber, be attached on the surface of connecting pin, also can be the strip through bending with shape retentivity, thus make this caged sleeve 180 have identical with the shape of cross section of described connecting pin 15 first barrel 1802, identical with the shape of cross section of described extension lead 14 second barrel 1804 and three barrel 1806 identical with the shape of cross section of described electrode cable 16.
Refer to Figure 17, this utility model the 4th embodiment provides a kind of implanted lesions located in deep brain device 10C of MRI compatible, and it comprises: controller 12, extension lead 14, connecting pin 15, one electrode cable 16 and a bindiny mechanism 18.
The structure of the implanted lesions located in deep brain device 10 of the MRI compatible that the implanted lesions located in deep brain device 10C of the MRI compatible that this utility model the 4th embodiment provides provides with this utility model first embodiment is substantially identical, its difference is, sleeve 180 and the securing member 182 of described bindiny mechanism 18 are elasticity tubular film, and adopt the conductive material having the elasticity of biocompatibility good to make, such as, there is the conducting high polymers thing or conductive silicon rubber etc. of biocompatibility.
Be appreciated that described sleeve 180 is just as balloon, shape is not in its natural state limit, but has a shape consistent with connecting portion 19 after being sheathed on connecting portion 19.In the present embodiment, there is under described sleeve 180 naturalness identical with the shape of cross section of described connecting pin 15 first barrel 1802, identical with the shape of cross section of described extension lead 14 second barrel 1804 and three barrel 1806 identical with the shape of cross section of described electrode cable 16.Described securing member 182 is two elastic rings.
The described sleeve 180 of elasticity tubular membrane structure can adopt the method for Figure 15 to be connected with the securing member 182 of elastic ring structure.As long as be appreciated that having elastic sleeve 180 all can adopt the method for Figure 15 to be connected with securing member 182.
Refer to Figure 18, this utility model the 5th embodiment provides a kind of implanted lesions located in deep brain device 10D of MRI compatible, and it comprises: controller 12, extension lead 14, connecting pin 15, one electrode cable 16 and a bindiny mechanism 18.
The structure of the implanted lesions located in deep brain device 10 of the MRI compatible that the implanted lesions located in deep brain device 10D of the MRI compatible that this utility model the 5th embodiment provides provides with this utility model first embodiment is substantially identical, its difference is, the sleeve 180 of described bindiny mechanism 18 is structure as a whole with the conductive shielding layer 146 of described extension lead 14 outer surface.
Particularly, described connecting pin 15 is structure as a whole with described extension lead 14.First barrel 1802 of the sleeve 180 of described bindiny mechanism 18 is sheathed on this connecting pin 15 outer surface, and it is outside that the 3rd barrel 1806 then extends to this connecting pin 15.After the socket 150 of this connecting pin 15 is inserted in one end of described electrode cable 16, the 3rd barrel 1806 can be shunk and is fitted on the conductive shielding layer 166 of described electrode cable 16 outer surface.Be appreciated that, described connecting pin 15 can not be integrative-structure with described extension lead 14 yet, as long as guarantee that the internal diameter of this sleeve 180 is greater than the external diameter of this connecting pin 15, or the internal diameter of this sleeve 180 can strut the external diameter being deformed into and being greater than this connecting pin 15.
In the present embodiment, preferably, the conductive shielding layer 166 of the sleeve 180 of described bindiny mechanism 18, the conductive shielding layer 146 of described extension lead 14 outer surface and described electrode cable 16 outer surface is the network structure adopting the marmem with biocompatibility to be compiled into.Sleeve 180 and the described conductive shielding layer 146 of described bindiny mechanism 18 are once worked out.The sleeve 180 of described bindiny mechanism 18, through shape memory process, has memory structures.
Refer to Figure 19, this utility model the 6th embodiment provides a kind of implanted lesions located in deep brain device 10E of MRI compatible, and it comprises: controller 12, extension lead 14, connecting pin 15, one electrode cable 16 and a bindiny mechanism 18.
The structure of the implanted lesions located in deep brain device 10D of the MRI compatible that the implanted lesions located in deep brain device 10E of the MRI compatible that this utility model the 6th embodiment provides provides with this utility model the 5th embodiment is substantially identical, its difference is, the sleeve 180 of described bindiny mechanism 18 is structure as a whole with the conductive shielding layer 166 of described electrode cable 16 outer surface.
Particularly, described connecting pin 15 is structure as a whole with described electrode cable 16.First barrel 1802 of the sleeve 180 of described bindiny mechanism 18 is sheathed on this connecting pin 15 outer surface, and it is outside that the second barrel 1804 then extends to this connecting pin 15.After the socket 150 of this connecting pin 15 is inserted in one end of described extension lead 14, this second barrel 1804 can be shunk and is fitted on the conductive shielding layer 146 of described extension lead 14 outer surface.Be appreciated that, described connecting pin 15 can not be integrative-structure with described electrode cable 16 yet, as long as guarantee that the internal diameter of this sleeve 180 is greater than the external diameter of this connecting pin 15, or the internal diameter of this sleeve 180 can strut the external diameter being deformed into and being greater than this connecting pin 15.
In the present embodiment, preferably, the conductive shielding layer 166 of the sleeve 180 of described bindiny mechanism 18, the conductive shielding layer 146 of described extension lead 14 outer surface and described electrode cable 16 outer surface is the network structure adopting the marmem with biocompatibility to be compiled into.Sleeve 180 and the described conductive shielding layer 166 of described bindiny mechanism 18 are once worked out.The sleeve 180 of described bindiny mechanism 18, through shape memory process, has memory structures.
As shown in figure 20, the implanted lesions located in deep brain device 10 of MRI compatible described in the utility model first by described extension lead 14 and electrode cable 16 implant into body different parts respectively, then adopts connecting portion to be connected with electrode cable 16 by described extension lead 14 when applying.Extension lead 14 can be connected with the conductive shielding layer on electrode cable 15 by bindiny mechanism 18 of the present utility model, guarantees that screen layer has good inhibition to stimulating the RF pyrogenicity temperature rise at contact place.Bindiny mechanism 18 of the present utility model installs simple and quick, uniform force, connects reliable.
In addition, those skilled in the art can also do other changes in this utility model spirit, and these changes done according to this utility model spirit all should be included in this utility model scope required for protection.

Claims (14)

1. a split implantable medical devices for MRI compatible, it comprises:
One controller;
One extension lead, the outer surface of described extension lead is coated with conductive shielding layer;
One electrode cable, the outer surface of described electrode cable is coated with conductive shielding layer;
One connecting pin, described connecting pin is for connecting this extension lead and electrode cable thus forming a junction position; And
One bindiny mechanism, described bindiny mechanism comprises the sleeve that conductive material that an employing has biocompatibility is made, and this sleeve is used for the conductive shielding layer of the conductive shielding layer of described extension lead outer surface with described electrode cable outer surface to be electrically connected.
2. the split implantable medical devices of MRI compatible as claimed in claim 1, it is characterized in that, described sleeve is a helical spring structure, and this helical spring structure inner surface is in its natural state consistent with the external surface shape of described connecting portion.
3. the split implantable medical devices of MRI compatible as claimed in claim 2, it is characterized in that, described sleeve is Reducing screw spring structure; And this Reducing screw spring structure has first barrel identical with the shape of cross section of described connecting pin, second barrel identical with the shape of cross section of described extension lead and three barrel identical with the shape of cross section of described electrode cable in its natural state.
4. the split implantable medical devices of MRI compatible as claimed in claim 2, it is characterized in that, described helical spring structure cross-sectional area S7 is in its natural state less than the cross-sectional area S8 of the connecting portion of its correspondence, and meets relation: (S8-S7)/S8≤10%.
5. the split implantable medical devices of MRI compatible as claimed in claim 1, it is characterized in that, described sleeve is an elasticity tubular film, and this sleeve adopts the conducting high polymers thing or conductive silicon rubber preparation with biocompatibility.
6. the split implantable medical devices of MRI compatible as claimed in claim 1, it is characterized in that, described in there is biocompatibility conductive material be have biocompatibility metal material, have biocompatibility carbon-based material and have in the conducting high polymers thing of biocompatibility one or more.
7. the split implantable medical devices of MRI compatible as claimed in claim 6, it is characterized in that, described in there is biocompatibility metal material be one or many in platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, rustless steel, Nitinol and cobalt-base alloys.
8. the split implantable medical devices of MRI compatible as claimed in claim 1, it is characterized in that, the conductive shielding layer of described sleeve and described extension lead outer surface is structure as a whole, or the conductive shielding layer of described sleeve and described electrode cable outer surface is structure as a whole.
9. the split implantable medical devices of MRI compatible as claimed in claim 1, it is characterized in that, described bindiny mechanism comprises the elastic fastener for this sleeve being fixed on this connecting portion further, and it adopts the elastomeric material with biocompatibility to make; Described elastic fastener is helical spring structure or film cylinder structure.
10. the split implantable medical devices of MRI compatible as claimed in claim 9, it is characterized in that, described elastic fastener cross-sectional area S9 is in its natural state less than the cross section S0 of the final structure of the described sleeve of its correspondence, and meets relation: (S0-S9)/S9≤10%.
The split implantable medical devices of 11. MRI compatible as claimed in claim 1, it is characterized in that, described sleeve adopts the shape-memory alloy fibers braiding with biocompatibility to form, and this sleeve has memory structures through shape memory heat treatment, make this sleeve contraction distortion can become a tubular structure consistent with described connecting portion external surface shape when being heated and reaching transition temperature.
The split implantable medical devices of 12. MRI compatible as claimed in claim 11, is characterized in that, described in there is the shape-memory alloy fibers of biocompatibility diameter be more than or equal to 0.02 millimeter and be less than or equal to 0.2 millimeter.
The split implantable medical devices of 13. MRI compatible as claimed in claim 11, is characterized in that, described in there is biocompatibility shape-memory alloy fibers be Ti-Ni marmem fiber.
The split implantable medical devices of 14. MRI compatible as claimed in claim 11, is characterized in that, the transition temperature of described sleeve is between 45 DEG C ~ 90 DEG C.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104606781A (en) * 2015-01-19 2015-05-13 清华大学 MRI-compatible split implantable medical device
WO2020019307A1 (en) * 2018-07-27 2020-01-30 尚华 Memory metal optical fiber puncture needle tube

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104606781A (en) * 2015-01-19 2015-05-13 清华大学 MRI-compatible split implantable medical device
WO2020019307A1 (en) * 2018-07-27 2020-01-30 尚华 Memory metal optical fiber puncture needle tube

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