CN104606780B - Implantable medical devices of a kind of MRI compatible and attaching method thereof and bindiny mechanism - Google Patents
Implantable medical devices of a kind of MRI compatible and attaching method thereof and bindiny mechanism Download PDFInfo
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- CN104606780B CN104606780B CN201510025781.4A CN201510025781A CN104606780B CN 104606780 B CN104606780 B CN 104606780B CN 201510025781 A CN201510025781 A CN 201510025781A CN 104606780 B CN104606780 B CN 104606780B
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Abstract
The present invention relates to the split implantable medical devices of a kind of MRI compatible, comprising: 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 connects plug, and described connection plug is used for connecting this extension lead and electrode cable thus forms a junction position；And a bindiny mechanism, this bindiny mechanism makes with the marmem with biocompatibility, electrically connect for making extension lead be formed with the conductive shielding layer on electrode cable, it is ensured that screen layer has good inhibition to the RF pyrogenicity temperature rise at stimulation contact.The present invention relates to the method for attachment of the split implantable medical devices of a kind of MRI compatible.
Description
Technical field
The present invention relates to implantable medical devices field, particularly relate to the implantable medical of a kind of MRI compatible
The bindiny mechanism of the screen layer of apparatus and method of attachment, and use the planting of MRI compatible of this bindiny mechanism
Enter formula medical apparatus and instruments.
Background technology
Mr imaging technique (Magnetic Resonance Imaging, MRI) and other imaging techniques (as
X-ray, CT etc.) compare, have and compare significant advantage: nuclear magnetic resonance is relatively sharp, to soft group
It is woven with the highest resolving power, and to human body without ionization radiation injury.So, mr imaging technique quilt
It is widely used among the clinical diagnosis of modern medicine.According to estimates, the nowadays whole world annual the most at least 6000
Ten thousand cases utilize nmr imaging technique to check.
Have three magnetic fields during MRI work to play a role.The homogeneous static magnetic field B0 of one high intensity, one
The individual gradient magnetic that can be adjusted to any direction, and radio frequency (RF) magnetic field for excited nucleus magnetic resonance.
What wherein the intensity of magnetostatic field B0 was common works in coordination with work for 1.5T and 3.0T, magnetostatic field B0 with gradient magnetic
Make to provide the spatial positional information of magnetic resonance signal；And radio-frequency (RF) magnetic field be one high-power, high-frequency
Time-varying magnetic field, its frequency is Larmor frequency, i.e. f=γ B0, wherein γ=42.5MHz/T.So,
In the common MRI that magnetostatic field B0 is 1.5T or 3.0T, the frequency of radio-frequency (RF) magnetic field respectively may be about 64MHz
And 128MHz.
Although MRI will not have directly injury to human body, but if is provided with implanted doctor in the patient
Treat apparatus (Implantable Medical Device, IMD), such as: cardiac pacemaker, defibrillator, fan
Walk nerve stimulator, spinal stimulator, lesions located in deep brain device etc., then, required during MRI work
Three magnetic fields used bring safely the biggest hidden danger will to the life and health of patient.Most important of which
One hidden danger is that implantable medical devices sensing in radio frequency (Radio Frequency, RF) magnetic field is sent out
Heat, especially for those with elongated conductive structures, and this elongated conductive structures can part and group
(the most such as lesions located in deep brain device is with extension lead and electrode cable, the heart to knit the medical apparatus and instruments of contact
Dirty pacemaker is with electrode wires).The internal patient equipped with these implantable medical devices sweeps carrying out MRI
The when of retouching, at the position of elongated conductive structures and contact tissue it is possible that serious temperature rise, so
Temperature rise patient can be caused serious injury.But, major part implants the patient of IMD at instrument life
Need to carry out MRI inspection in cycle, and the potential safety hazard that radio-frequency (RF) magnetic field sensing brings causes this part
Patient is rejected and checks.So, the MRI compatibility function meaning of exploitation implantable medical devices is notable,
And owing to the sensing heating effect of radio-frequency (RF) magnetic field is mainly reflected in elongated conductive structures such as electrode, so open
Send out and can will not cause serious temperature rise due to the sensing heating effect of radio-frequency (RF) magnetic field under MRI environment
Electrode has the highest market value and using value.
In order to overcome the problems referred to above, prior art is in the wire appearance of the implantable medical devices of MRI compatible
Face arranges conductive shielding layer.But, for reasons of each side such as facilitating operation, guarantee reliability, existing
Some implantable medical devices are frequently with split-type structural, i.e. wire is divided into be connected with controller prolong
Long wire and the electrode cable being connected with stimulating electrode contact.This prolongation just can be led by operation process
Line links together with electrode cable.But, with existing technology, at extension lead with electrode cable even
In termination process, it is covered in the conductive shielding layer of extension lead outer surface and is covered in electrode cable outer surface
Electrical connection cannot be directly realized by between conductive shielding layer.Owing to RF thermal effect is pressed down by conductive shielding layer
Ability processed depend heavilys on the integrity of screen layer, say, that the conductive shielding layer of various piece it
Between necessarily be formed electrical connection, just can make conductive shielding layer effectively play the suppression to RF thermal effect make
With.Therefore, prior art cannot play RF cause effectively at the implantable medical devices of MRI compatible
The inhibitory action of heat effect.
Summary of the invention
In view of this, necessary offer is a kind of can be by the prolongation of the implantable medical devices of MRI compatible
Bindiny mechanism that wire is connected with the screen layer of electrode cable and method of attachment, and use this bindiny mechanism
The implantable medical devices of MRI compatible.
A kind of implantable medical devices of MRI compatible, comprising: a controller；One extension lead, institute
The outer surface stating extension lead is coated with conductive shielding layer；One electrode cable, the appearance of described electrode cable
Face is coated with conductive shielding layer；One connects plug, and described connection plug is used for connecting this extension lead and electricity
Polar conductor thus form a junction position；And a bindiny mechanism, described bindiny mechanism includes an employing tool
Having the shroud sleeve that the marmem of biocompatibility is made, this shroud sleeve has an initiating structure,
And this shroud sleeve has memory structures through shape memory heat treatment so that this shroud sleeve is being heated
A tubular consistent with described connecting portion external surface shape can be become with contraction distortion when reaching transition temperature
Structure, this tubular structure is for by the conductive shielding layer of described extension lead outer surface and described electrode cable
The conductive shielding layer of outer surface is electrically connected.
A kind of method of attachment of the implantable medical devices of MRI compatible as above, the method include with
Lower step: use described connection plug to connect described electrode cable and extension lead thus form this connecting portion
Position；Described shroud sleeve is sheathed on this connecting portion；And heat described shroud sleeve and make it shrink change
Formed first barrel corresponding with described connection plug, one with the leading of described extension lead outer surface
Second barrel of shield layer electrical connection and one with the conductive shield of described electrode cable outer surface
3rd barrel of layer electrical connection.
The bindiny mechanism of a kind of implantable medical devices for MRI compatible, wherein, this bindiny mechanism wraps
Include an employing and there is shroud sleeve that the marmem of biocompatibility makes and two employings have
The dead ring that the shape memory alloy material of biocompatibility is made；This shroud sleeve has an initiating structure,
And this shroud sleeve has memory structures through shape memory heat treatment so that this shroud sleeve is being heated
One and extension lead and the connecting portion appearance of electrode cable can be become with contraction distortion when reaching transition temperature
The tubular structure that face shape is consistent, this tubular structure is for by the conductive shield of described extension lead outer surface
Layer electrically connects with the conductive shielding layer of described electrode cable outer surface；Described dead ring is sheathed on cylinder when using
In shape structure；Described dead ring has memory structures through shape memory heat treatment so that this dead ring
Can shrink when being heated and reaching transition temperature, thus this tubular structure is securely fastened to connecting portion
Outer surface.
Compared with prior art, the bindiny mechanism that the present invention provides, can lead extension lead with electrode
Conductive shielding layer on line is connected, it is ensured that the RF pyrogenicity temperature rise at stimulation contact is had good by screen layer
Good inhibition.When the bindiny mechanism of the present invention uses, made the shape with biocompatibility by heating
The shroud sleeve that shape memory alloys is made shrinks, and installs simple and quick, connects reliable.
Accompanying drawing explanation
The implanted lesions located in deep brain device of the MRI compatible that Fig. 1-3 provides for first embodiment of the invention is even
Structural representation before connecing and after connection.
The implanted lesions located in deep brain device of the MRI compatible that Fig. 4-6 provides for first embodiment of the invention
Structure changes.
The company of the implanted lesions located in deep brain device of the MRI compatible that Fig. 7 provides for first embodiment of the invention
The schematic diagram of another initiating structure of connection mechanism.
The company of the implanted lesions located in deep brain device of the MRI compatible that Fig. 8 provides for first embodiment of the invention
The preparation method flow chart of the netted sleeve of connection mechanism.
The structural representation of the difform braiding mould used when Fig. 9 is to prepare netted sleeve in Fig. 8.
The implanted lesions located in deep brain device of the MRI compatible that Figure 10-11 provides for first embodiment of the invention
The cross sectional representation of dead ring of bindiny mechanism.
The implanted lesions located in deep brain device of the MRI compatible that Figure 12 provides for first embodiment of the invention
The preparation method flow chart of the dead ring of bindiny mechanism.
The implanted lesions located in deep brain device of the MRI compatible that Figure 13 provides for first embodiment of the invention
Method of attachment flow chart.
The implanted lesions located in deep brain device of the MRI compatible that Figure 14 provides for second embodiment of the invention is even
Structural representation before connecing.
The implanted lesions located in deep brain device of the MRI compatible that Figure 15 provides for second embodiment of the invention
Method of attachment flow chart.
The implanted lesions located in deep brain device of the MRI compatible that Figure 16 provides for third embodiment of the invention is even
Structural representation before connecing.
The implanted lesions located in deep brain device of the MRI compatible that Figure 17 provides for fourth embodiment of the invention is even
Structural representation before connecing.
The implanted lesions located in deep brain device of the MRI compatible that Figure 18 provides for fifth embodiment of the invention is even
Structural representation before connecing.
The implanted lesions located in deep brain device of the MRI compatible that Figure 19 provides for sixth embodiment of the invention is even
Structural representation before connecing.
Figure 20 embodiment of the present invention provide MRI compatible implanted lesions located in deep brain device application 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
Connect plug 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 the present invention in conjunction with above-mentioned accompanying drawing.
Detailed description of the invention
The implantable medical devices of MRI compatible that the present invention provides can be cardiac pacemaker, defibrillator,
Lesions located in deep brain device, spinal stimulator, vagus nerve stimulator, the intestines and stomach stimulator or other be similar to
Implantable medical devices.The present invention only illustrates as a example by lesions located in deep brain device.
The implantable medical devices of the MRI compatible that the present invention provides is split-type structural, and extension lead
It is all covered with conductive shielding layer with the outer surface of electrode cable.The purpose of the present invention is for using a bindiny mechanism
The conductive shielding layer that the outer surface of this extension lead with electrode cable covers is linked into an integrated entity, it is ensured that shielding
Layer has good inhibition to the RF pyrogenicity temperature rise at stimulation contact.Further, the present invention provides
Various different bindiny mechanisms and method of attachment so that the installation of above-mentioned bindiny mechanism is simple and quick,
Connect reliable, and be more practically applicable to implant surgery process.
Described bindiny mechanism includes a sleeve.Described sleeve uses conductive material to make, and this sleeve is permissible
Contraction distortion becomes a cylinder consistent with the external surface shape of described extension lead and the connecting portion of electrode cable
Shape structure.Preferably, described sleeve itself uses the conductive material with biocompatibility to make.Described
Having the conductive material of biocompatibility is to have the metal material of biocompatibility, have biocompatibility
Carbon-based material and one or more during there is the conducting high polymers thing of biocompatibility.Described
Having the metal material of biocompatibility is platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, stainless
One or many in steel, Nitinol and cobalt-base alloys.It is appreciated that if the conduction material of this sleeve
Material does not have biocompatibility, then need to arrange other guarantor with biocompatibility outside bindiny mechanism
Protective material.For ease of producing bigger deformation in operation process easily, described sleeve can design
For netted, helical form, the caged that include but not limited to, or the structure such as tubular film.It is appreciated that institute
State bindiny mechanism and can also include a conductive film or wire, during use, this conductive film or wire are wound around
Or be wrapped in connecting portion outer surface thus form a sleeve.
Further, described bindiny mechanism could be included for being firmly secured to this sleeve this connecting portion
Securing member.When using bindiny mechanism provided by the present invention to connect, treat that described sleeve collapses is to finally
After structure, said two securing member is respectively fitted over 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 being placed in ring, from
And this sleeve is firmly secured to outside this connecting portion.Preferably, described securing member uses and has biofacies
The material of capacitive is made, and the described material with biocompatibility includes but not limited to have bio-compatible
Metal material such as platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, rustless steel, the Nitinol of property
Or cobalt-base alloys etc., and there are carbon-based material or the high molecular polymer etc. of biocompatibility.Described tightly
The firmware parts to being placed in ring around in the range of produce the method for certain normal pressure and do not limit, permissible
The method used includes but not limited to: utilizes elastic contractile force, utilize the shape memory of shape-memory material
Effect and other external force etc..It is appreciated that described securing member is optional structure.
The method of attachment using the implantable medical devices of the MRI compatible of described bindiny mechanism includes following
Step: step S10, uses connection plug to connect described electrode cable and extension lead thus forms one even
Connect position；And step S20, the sleeve of described bindiny mechanism is sheathed on this connecting portion, and makes institute
State colleting deformation to become outside first barrel corresponding with described connection plug, one and described extension lead
Second barrel and one of the conductive shielding layer electrical connection on surface is with described electrode cable outer surface
3rd barrel of conductive shielding layer electrical connection.Further, it is also possible to use described securing member by this set
Cylinder is firmly secured to this connecting portion.
Below in conjunction with the accompanying drawings and the specific embodiments, the implantable medical to the MRI compatible that the present invention provides
The bindiny mechanism of the screen layer of apparatus and method of attachment, and use the planting of MRI compatible of this bindiny mechanism
Enter formula medical apparatus and instruments to be described in further detail.
Referring to Fig. 1-3, first embodiment of the invention provides the implanted brain deep electricity of a kind of MRI compatible
Stimulator 10, comprising: controller 12, extension lead 14, connects plug 15, electrode
Wire 16 and a bindiny mechanism 18.One end of described extension lead 14 is electrically connected with described controller 12
Connecing, the other end is for electrically connecting with described electrode cable 16.One end of described electrode cable 16 for
Described extension lead 14 electrically connects, and the other end is for providing electrical stimulation signal to organism.Described connection is inserted
15 are used for connecting described extension lead 14 and electrode cable 16.Described extension lead 14 and electrode are led
The outer surface of line 16 is all covered with conductive shielding layer.When described extension lead 14 and electrode cable 16 pass through
After the electrical connection of described connection plug 15, described bindiny mechanism 18 is for by described extension lead 14 and electrode
The conductive shielding layer electrical connection of wire 16 outer surface, thus effectively suppress this MRI under MRI scan environment
RF pyrogenicity temperature rise at the electrode contacts of compatible implanted lesions located in deep brain device 10.
Described electrode cable 16 includes: a flexible insulation conduit 160, and this flexible insulation conduit 160 has
One first end and second end relative with this first end；At least a connector 162 is arranged at this flexibility
The outer surface of the first end of insulated conduit 160；At least one electrode contacts 164 is arranged at this flexible insulation and leads
The outer surface of the second end of pipe 160；And one spiral conducting line (not shown) be arranged at this flexible insulation and lead
Pipe 160 is internal, and this spiral conducting line is by described at least one electrode contacts 164 and at least a connector 162
Electrical connection.
Described flexible insulation conduit 160 acts primarily as this at least a connector 162 and at least one electrode of support and touches
Point 164, and protect the effect of this spiral conducting line and exterior insulation.Described flexible insulation conduit 160
Length, internal diameter and external diameter do not limit, can according to clinical treatment need select.Described flexible insulation is led
Pipe 160 is made up of one or more materials in polyurethane material, silastic material and nylon material.Institute
The outer surface stating flexible insulation conduit 160 is coated with conductive shielding layer.Described conductive shielding layer uses to be had
The metal material of biocompatibility, has conducting high polymers thing or the conductive carbon material of biocompatibility
Preparation.In the present embodiment, described flexible insulation conduit 160 is a cylindrical polyurethane tube, and this flexibility
Insulated conduit 160 is an enclosed construction near the end of at least one electrode contacts 164.Described flexible insulation
The outer surface of conduit 160 is coated with the conductive shielding layer that rustless steel is made.
Described at least a connector 162 is for electrically connecting this spiral conducting line with described extension lead 14.Institute
State and implant in organism when at least one electrode contacts 164 uses, for applying electricity irritation to organism.Institute
State at least a connector 162 and at least one electrode contacts 164 by the electric good conductor with biocompatibility
Material is made.Preferably, the described electric good conductor material with biocompatibility can be to have biology
The metal material of the compatibility, has the conducting high polymers thing of biocompatibility, and CNT and carbon are received
One or more in mitron composite.Described at least a connector 162 and at least one electrode contacts 164
Quantity and size do not limit, can select as required.In the present embodiment, four adapters 162 and four
Individual electrode contacts 164 is respectively separated the two ends being arranged at this flexible insulation conduit 160, and passes through four-wire type
Spiral conducting line one_to_one corresponding electrically connects.Each adapter 162 or electrode contacts 164 are ring-type and cincture
It is coated on the outer surface of this flexible insulation conduit 160.
Described spiral conducting line comprises an electric wire with biocompatibility and and is arranged at this conductor wire
The insulating polymer material coating of material outer surface.The macromolecular material of described coating can be polyurethane, silicon
In rubber, nylon, fluoro-containing plastic (such as PTFE, ETFE etc.), Pai Lalun and polyimides
One or more.The multilamellar that described coating can be the monolayer by single type material or multiple material is formed
Structure.Preferably, the electric wire of described spiral conducting line is by the electric good conductor material with biocompatibility
Make, for transmitting the signal of telecommunication between described at least a connector 162 and at least one electrode contacts 164.
Number of conductors and the number of turn of described spiral conducting line do not limit, and can select as required.In the present embodiment, institute
Stating spiral conducting line is four-wire type structure, has four wires, and every wire by a connector 162 with right
The electrode contacts 164 answered electrically connects.
Described controller 12 is for receiving from the incoming signal of telecommunication of described electrode cable 16 or to described electrode
Output voltage or electric current.The structure of described controller 12 and type can be according to the use of implantable medical devices
Way is designed and selects.
Described extension lead 14 includes a flexible multi-cavity insulated conduit 140 and, and to be arranged at this flexibility multi-cavity exhausted
Spiral conducting line (not shown) in edge conduit 140.Spiral conducting line in described extension lead 14 is from flexibility
Multi-cavity insulated conduit 140 passes.In the present embodiment, described flexible multi-cavity insulated conduit 140 is four chambeies
Cylinder, makes with silicone rubber, and the outer surface of described flexible multi-cavity insulated conduit 140 is coated with stainless
The screen layer that steel is made.The external diameter of described flexible multi-cavity insulated conduit 140 is more than described flexible insulation conduit
The external diameter of 160.
Described connection plug 15 is arranged at this flexibility multi-cavity insulated conduit 140 away from described controller 12
End and electrically connecting with this flexibility multi-cavity insulated conduit 140.Described connection plug 15 uses and flexible multi-cavity
Prepared by the material that insulated conduit 140 is identical.In the present embodiment, described flexible multi-cavity insulated conduit 140
With the described one-body molded preparation of connection plug 15.Described connection plug 15 has a socket 150, is used 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 electrically connects with described controller 12, and the other end is with described
Multiple connecting terminals electrical connection in socket 150.When this socket is inserted in one end of described electrode cable 16
When 150, the adapter 162 of described electrode cable 16 by with the multiple connecting terminals in described socket 150
One_to_one corresponding contacts, so that this electrode cable 16 is fixed with described extension lead 14 and realized electrically connecting.
It is appreciated that described connection plug 15 and the part extension lead 14 of this connection plug 15 close and portion
Sub-electrode wire 16 is collectively forming a junction position 19.In the present embodiment, described connection plug 15 is circle
Cylindricality, and use silicone rubber to prepare.The external diameter of described connection plug 15 is led more than described flexible multi-cavity insulation
The external diameter of pipe 140.Described socket 150 is cylindrical, and diameter is equal to described electrode cable 16 external diameter.
It is appreciated that in addition to scheme as shown in Figure 1, as shown in Figure 4, described connection plug 15
Also can be with the described one-body molded preparation of flexible insulation conduit 160；The most described connection plug 15 has one
Socket 150, is used for housing part extension lead 14, and arranges multiple company at described socket 150 inner surface
Contact point.At extension lead 14, multiple adapter 142 is set away from one end of described controller 12, when
When this socket 150 is inserted in one end of described extension lead 14, the adapter 142 of described extension lead 14
To contact with the multiple connecting terminal one_to_one corresponding in described socket 150, so that this electrode cable 16
Fix with described extension lead 14 and realize electrically connecting.
In addition to above two scheme, as shown in Figure 5, it is also possible to be independently arranged connection plug 15, make institute
The connection plug two ends stated are respectively provided with socket 150, are respectively used to house part extension lead 14 and part
Electrode cable 16.At described socket 150 inner surface, multiple connecting terminal, table in two sockets 150 are set
The connecting terminal in face one_to_one corresponding respectively, and be attached with wire.Arrange in one end of extension lead 14
Multiple adapters 142, when described socket 150 is inserted in one end of described extension lead 14, described connection
Device 142 will contact with the multiple connecting terminal one_to_one corresponding in described socket 150；At electrode cable 16
One end multiple adapter 162 is set, when another socket 150 is inserted in one end of described electrode cable 16,
Described adapter 162 will contact with the multiple connecting terminal one_to_one corresponding in described socket 150；So that
This electrode cable 16 is fixed with described extension lead 14 and is realized electrically connecting.
It is appreciated that as shown in Figure 6, described extension lead 14, connect plug 15 and described electrode
The part that wire 16 is exposed at outside this connection plug 15 can also have identical external diameter, simply this electrode
Wire 16 inserts the external diameter external diameter less than other parts of the part of this connection plug 15.When this electrode is led
After line 16 inserts the realization connection of described connection plug 15, the implantable medical devices of described MRI compatible
There is homogeneous external diameter.
Described bindiny mechanism 18 includes a sleeve 180 and two securing members 182.Described sleeve 180 He
Two securing members 182 all use the shape-memory material with biocompatibility to make.Described has life
The conductive shapes memory material of the thing compatibility includes but not limited to titanium nickel (TiNi) marmem, shape
Memory conducting high polymers thing etc..
Described sleeve 180 is through shape memory heat treatment so that this sleeve 180 be heated reach change
Can become with contraction distortion during temperature is one and the connecting portion of described implanted lesions located in deep brain device 10
The tubular structure that 19 external surface shape are consistent.Described transition temperature can as required depending on.Preferably,
Transition temperature should be between 45 DEG C～90 DEG C.It is appreciated that as the sleeve 180 described in guarantee not at body temperature
Near i.e. shrink deformation, transition temperature should be not less than 45 DEG C, for ensure described in transition temperature permissible
Can reach in operation process with comparalive ease, transition temperature should be not higher than 90 DEG C.
Preferably, described sleeve 180 is a netted airtight tubular structure, so that this sleeve 180 has good
Good pliability and anti-fatigue performance and bigger deformation.Preferably, described sleeve 180 is a monolayer
Network structure, its fibrage using the conductive material with biocompatibility to make forms.Described volume
Organization method can be monofilament braiding or and silk braiding.Preferably, the described shape note with biocompatibility
The diameter recalling the fiber that alloy is made should be greater than equal to 0.02 millimeter and less than or equal to 0.2 millimeter.Can manage
Solving, have enough intensity and electric conductivity for the netted sleeve 180 described in ensureing, the diameter of fiber should
More than or equal to 0.02 millimeter, for the netted sleeve 180 described in ensureing, there is good pliability and resisting fatigue
Performance, the diameter of fiber should be less than equal to 0.2 millimeter.The length of described sleeve 180 is more than described connection
The length of plug 15.
For the ease of describing and understanding, description of the invention defined described sleeve 180 before contraction distortion
Structure be initiating structure, define described sleeve 180 at the transition temperature can with free shrink deformation formed
Structure be memory structures.Described initiating structure and memory structures refer to the shape and size of described sleeve 180.
Length and shape of cross section after the contraction distortion of described sleeve 180 are basically unchanged, but cross sectional dimensions is bright
Show and diminish.Seeing Fig. 2, the described sleeve 180 memory structures after contraction distortion are respectively provided with one and institute
State the first barrel 1802, one and described extension lead that the shape of cross section of connection plug 15 is identical
The second barrel 1804 that the shape of cross section of 14 is identical and one with the horizontal stroke of described electrode cable 16
The 3rd barrel 1806 that cross sectional shape is identical.Described second barrel 1804 is led with described prolongation
The conductive shielding layer contact of line 14 outer surface, and described 3rd barrel 1806 and described electrode cable
The conductive shielding layer contact of 16 outer surfaces, so that the conductive shield of described extension lead 14 outer surface
Layer and the conductive shielding layer of described electrode cable 16 outer surface are by the sleeve 180 after described contraction distortion
Electrical connection.It is appreciated that when using the structure shown in Fig. 6, described first barrel 1802, the
The diameter of two barrel 1804 and the 3rd barrel 1806 is the most identical with cross section.
Preferably, the internal diameter size of the memory structures of described sleeve 180 should be less than being equal to and described connecting portion
The outside dimension of position 19 correspondence positions.It is appreciated that when described sleeve 180 reaches through shape memory effect
Memory structures internal diameter size less than with the outside dimension of the correspondence position of described connecting portion 19 time, by
Final structure after the supporting role of connecting portion 19, the contraction distortion of described sleeve 180 is described set
Cylinder 180 contractilitys at the transition temperature reach the actual knot after balancing with the support force of connecting portion 19
Structure, therefore, the size of the final structure of described sleeve 180 will be greater than the size of memory structures.So,
Described sleeve 180 is closely adhered to intensity bigger connecting portion 19 surface, it is possible to obtain stable
Shape.Preferably, the cross-sectional area S1 of each barrel of the memory structures of described sleeve 180
Less than the cross-sectional area S2 of the connecting portion 19 of its correspondence, and meet relation: (S2-S1)/S2 10%,
With cover each barrel of the practical structures after sleeve 180 contraction distortion described in guaranteeing can be right with it
The outer surface of the connecting portion 19 answered fits tightly.Internal diameter size when the memory structures of described sleeve 180
When being equal to the outside dimension of the correspondence position of described connecting portion 19, the final structure of described sleeve 180
I.e. memory structures.
It is appreciated that the shape of cross section of the initiating structure of described sleeve 180 does not limits, can be as required
Select.As it is shown in figure 1, the initiating structure of described sleeve 180 can have homogeneous internal diameter.Preferably
Ground, this internal diameter should be greater than the maximum outside diameter equal to described connecting portion 19, in order to easily preparation is with sheathed.
Preferably, the shape of cross section of the initiating structure of described sleeve 180 and the described cross section being connected plug 15
Shape is identical, and the internal diameter of initiating structure is more than the external diameter of described connection plug 15.Cover described in it is highly preferred that
The cross-sectional area S3 of the initiating structure of the sleeve 180 and described cross-sectional area S4 being connected plug 15
Meet relation: (S3-S4)/S4 10%.As it is shown in fig. 7, also may be used of the initiating structure of described sleeve 180
To have inhomogenous internal diameter.Such as, the initiating structure part internal diameter of described sleeve 180 is less than other portion
Point, thus form threeth barrel 1806 identical with the shape of cross section of described electrode cable 16.
Then etc. during use, first the 3rd barrel 1806 is sheathed on described electrode cable 16, by described
After one end of electrode cable 16 is inserted in the socket 150 of described connection plug 15, then by this sleeve
180 movable sleevings are located at connecting portion 19, finally heated make these sleeve 180 other parts shrink deformation.
Referring to Fig. 8, first embodiment of the invention further provides for a kind of netted sleeve of above-mentioned shape memory
The preparation method of 180.The method comprises the following steps:
Step S10A: will there is the shape-memory alloy fibers 20 of biocompatibility at one and connecting portion
Braiding mould 30 surface weave that position 19 shapes are consistent is a mesh shields layer 181；
Step S20A: the mesh shields layer 181 braiding completed is carried out with described braiding mould 30 entirety
Shape memory heat treatment, so that this mesh shields layer 181 obtains the note of the shape to described braiding mould 30
Recall；And
Step S30A: this mesh shields layer 181 is taken off from described braiding mould 30, and in making it
Footpath expands, thus obtains a sleeve 180 with memory structures.
In described step S10A, special braiding apparatus is used to weave.Weaving method can be monofilament
Braiding or and silk braiding.For the netted sleeve 180 described in ensureing, there is enough intensity and electric conductivity,
The diameter of fiber 20 should be greater than equal to 0.02 millimeter, has well for the netted sleeve 180 described in ensureing
Pliability and anti-fatigue performance, the diameter of fiber 20 should be less than equal to 0.2 millimeter.See Fig. 9, institute
The shape stating braiding mould 30 can be carried out according to the shape of the nerve stimulator connection member of different model
Select.
In described step S20A, the mesh shields layer 181 braiding completed is whole with described braiding mould 30
Body is put into a heating furnace 40 and is carried out shape memory heat treatment.Described shape memory Principles of Heating Processing are by shape
Shape memory alloys is heated to more than transformation temperature so that it is be fully converted to parent phase (austenite).Will be through heating
Marmem part quench rapidly, then parent phase can be by quenching vacancy and interaction of dislocation
Strengthening.The temperature of heating is the highest, and Parent phase strengthening is the most notable, and the rate of cooling quenched is the fastest, also
The strengthening to parent phase can be strengthened.It is generally required to select different heating temperature according to different shape-memory materials
Degree and hardening media.
In described step S30A, make mesh shields layer 181 internal diameter this sleeve 180 can be made to have after expanding
There is uniform internal diameter, it is possible to have uneven internal diameter.
Described securing member 182 for being securely fastened to the outer surface of connecting portion 19 by sleeve 180, and makes
This sleeve 180 is the most electric with the conductive shielding layer of described extension lead 14 and electrode cable 16 outer surface
Connect.As it was noted above, in order to ensure that described netted sleeve 180 has good pliability and resists tired
Labor performance, the diameter of the fiber making described netted sleeve 180 should be less than equal to 0.2 millimeter.Permissible
Understanding, owing to fiber is relatively thin, its contractility is difficult to ensure that in described netted sleeve 180 and described prolongation
Connecing of the conductive shielding layer of wire 14 outer surface and the conductive shielding layer of described electrode cable 16 outer surface
Synapsis forms electrical connection reliably.The parts being placed in ring can be produced by described securing member 182 around
Raw certain normal pressure, when using bindiny mechanism 18 provided by the present invention to connect, treats described sleeve
After 180 are contracted to final structure, said two securing member 182 is respectively fitted over described sleeve 180
Second barrel 1804 and the outer surface of the 3rd barrel 1806 of final structure.By described pressure
Described second barrel 1804 and the 3rd barrel 1806 can be secured firmly to described prolongation by power
On the conductive shielding layer of wire 14 and electrode cable 16 outer surface.
In the present embodiment, described securing member 182 utilizes the shape memory effect of shape-memory material to quilt
The parts being placed in ring normal direction in the range of 360 ° around produces certain normal pressure, in order to just
In understanding and describing, this securing member 182 is defined as shape memory securing member 182 by this specification.
The structure that can realize shape memory securing member 182 includes but not limited to closed circular knot as shown in Figure 10
Structure or non-close circulus as shown in figure 11.When described securing member 182 closed circular structure, its
Can be to producing certain pressure in the range of the parts being placed in ring around 360 °.Described shape memory
Shape of cross section and the size of securing member 182 do not limit, can be according to supporting extension lead 14 and electrode
Depending on the cross section of wire 16.Described securing member 182 is dead ring, its cross section can be circle, rectangle,
Hexagon or other polygons.
If being appreciated that, the shape memory effect utilizing shape-memory material produces normal pressure, the most described shape
Shape memory securing member 182 must be made with the shape-memory material with biocompatibility.Described has
The shape-memory material of biocompatibility includes but not limited to that titanium nickel (TiNi) marmem, shape are remembered
Recall conducting high polymers thing etc..Described shape memory securing member 182 through shape memory heat treatment,
This shape memory securing member 182 is shunk, to the portion being placed in ring when being heated and reaching transition temperature
Part normal direction in the range of 360 ° around produces certain normal pressure.Described transition temperature can root
Depending on needs.Preferably, transition temperature should be between 45 DEG C～90 DEG C.It is appreciated that as ensureing institute
The shape memory securing member 182 stated i.e. does not shrinks deformation near body temperature, and transition temperature should be not less than
45 DEG C, can reach in operation process with comparalive ease for the transition temperature described in ensureing, change
Temperature should be not higher than 90 DEG C.
When using bindiny mechanism 18 provided by the present invention to connect, treat that described sleeve 180 is contracted to finally
After structure, said two shape memory securing member 182 is respectively fitted over the termination of described sleeve 180
Second barrel 1804 and the outer surface of the 3rd barrel 1806 of structure, and heat make said two
Shape memory securing member 182 shrinks because of shape memory function, thus by described second barrel 1804
It is secured firmly to described extension lead 14 and the screen of electrode cable 16 outer surface with the 3rd barrel 1806
Cover on layer.
For the ease of describing and understanding, description of the invention defines described shape memory securing member 182 and is receiving
Structure before compression deformation is initiating structure, defines described shape memory securing member 182 at the transition temperature
The structure that contraction distortion is formed is memory structures.Described initiating structure and memory structures refer to described securing member
The shape and size of 182.Length after the contraction distortion of described shape memory securing member 182 and cross section
Shape is basically unchanged, but cross sectional dimensions substantially diminishes.The length of described shape memory securing member 182 is fixed
Justice is that this shape memory securing member 182 is at the yardstick along the direction vertical with cross section.Described shape is remembered
Recall the Zhou Changwei 3.5 millimeters～15 millimeters of the initiating structure of securing member 182.Described shape memory securing member
The internal diameter size of the initiating structure of 182 is more than the second corresponding barrel 1804 or the 3rd barrel
The external diameter of 1806, so that the most sheathed.The memory structures of described shape memory securing member 182 interior
Footpath is smaller in size than the second barrel 1804 or external diameter of the 3rd barrel 1806 equal to correspondence, from
And make the shape memory securing member 182 after contraction distortion can be firmly by the second corresponding cylindrical portion
Points 1804 or the 3rd barrel 1806 be fixed to extension lead 14 or the surface of electrode cable 16.When
The internal diameter size of the memory structures of described shape memory securing member 182 is less than the second corresponding barrel
1804 or during the 3rd external diameter of barrel 1806, due to the supporting role of connecting portion 19, described shape
The final structure of shape memory securing member 182 by for described securing member 182 contractility at the transition temperature with
The support force of connecting portion 19 reaches the practical structures after balance, therefore, described shape memory securing member
The size of the final structure of 182 will be greater than the size of memory structures.Preferably, described shape memory fastening
The cross-sectional area S5 of the memory structures of part 182 is less than the second barrel 1804 or the 3rd of its correspondence
The cross-sectional area S6 of barrel 1806, and meet relation: (S6-S5)/S6 10%, to guarantee
State practical structures after shape memory securing member 182 contraction distortion can be corresponding the second tubular
Part 1804 or the 3rd barrel 1806 fit tightly.Note when described shape memory securing member 182
The internal diameter size recalling structure is equal to outside the second corresponding barrel 1804 and the 3rd barrel 1806
During footpath, the final structure i.e. memory structures of described shape memory securing member 182.
In the embodiment of the present invention, described bindiny mechanism 18 includes a sleeve 180 and two securing members 182.
The initiating structure of described sleeve 180 is the cylinder that internal diameter is homogeneous, memory structures include one first cylinder and
It is positioned at these the first cylinder two ends and the second cylinder connected with this first cylinder and the 3rd cylinder.Described second
The diameter of cylinder and the 3rd cylinder is less than the diameter of this first cylinder.The internal diameter of described first cylinder is equal to institute
State the outer warp connecting plug 15.Described second cylinder and the 3rd barrel bore are respectively equal to described extension lead
14 and the outer warp of electrode cable 16.The utilizing elastic contractile force, utilize shape of said two securing member 182
The shape memory effect of the shape memory material parts to being placed in ring normal in the range of 360 ° around
Direction produces certain normal pressure, by described second barrel 1804 and the 3rd barrel 1806 jail
Firmly it is scheduled on the screen layer of described extension lead 14 and electrode cable 16 outer surface.
Referring to Figure 12, first embodiment of the invention further provides for a kind of above-mentioned shape memory securing member
The preparation method of 182.The method comprises the following steps:
Step S10B: utilize processing mold 32 to process internal diameter than extension lead 14 or electrode cable 16
The shape memory securing member 182 that external diameter is smaller；
Step S20B: marmem securing member 182 is carried out together with mould 32 shape memory heat
Processing, 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 make its internal diameter expand.
In described step S10B, described mould 32 have a uniform taper end of diameter and with this taper end pair
The most thicker butt end answered.Described securing member 182 is formed and in this taper end.The shape of described mould 32
Can select 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 one with mould 32 entirety
Shape memory heat treatment is carried out in heating furnace 42.
In described step S30B, shape memory securing member 182 is pushed the butt end of mould 32 to, by shape
The internal diameter of memory securing member 182 expands, and then takes off from mould 32.
Referring to Figure 13, first embodiment of the invention further provides for the above-mentioned bindiny mechanism 18 of a kind of employing
The method that the conductive shielding layer of described extension lead 14 and electrode cable 16 outer surface is electrically connected.The party
Method comprises the following steps:
Step S10C: one end of described electrode cable 16 is inserted the socket 150 of described connection plug 15
In thus form a junction position 19；
Step S20C: described sleeve 180 is sheathed on this connecting portion 19；
Step S30C: heat described sleeve 180 and make its contraction distortion become one with described to be connected plug 15 right
The first barrel 1802, answered electrically connects with the conductive shielding layer of described extension lead 14 outer surface
The second barrel 1804 and be electrically connected with the conductive shielding layer of described electrode cable 16 outer surface
The 3rd barrel 1806 connect；
Step S40C: the first securing member 182 is sheathed in this second barrel 1804, and by
Two securing members 182 are sheathed in the 3rd barrel 1806；And
Step S50C: heat described first securing member 182 and the second securing member 182, makes this first fastening
Part 182 contraction distortion the outer surface with this second barrel 1804 fit tightly, and make this second tight
Firmware 182 contraction distortion the outer surface with the 3rd barrel 1806 fit tightly.
In described step S10C, described electrode cable 16 has one end of adapter 162 and inserts described company
In the socket 150 of patch plug 15, and this adapter 162 and the connecting terminal one_to_one corresponding in socket 150
Contact electrical connection.
In described step S20C, after described sleeve 180 is sheathed on this connecting portion 19, described company
Patch plug 15 is completely disposed in described sleeve 180.It is appreciated that and described sleeve 180 is sheathed on this company
Before connecing position 19, it is also possible to first use a diaphragm seal to cover this connecting portion 19, to prevent liquid from oozing
Short circuit is caused in entering this connecting portion 19.
In described step S30C, the mode heating described sleeve 180 does not limits, as long as guaranteeing this sleeve 180
Can be with thermally equivalent, the heating means that can use include but not limited to: hot-water soak, hot blast blow,
Portable heating device is used to carry out heating etc..Described heating-up temperature is 45 DEG C～90 DEG C.Described sleeve 180
The contraction distortion because of shape memory function, covers equably on connecting portion 19 surface, and at two ends respectively
Overlap joint is formed with the screen layer on extension lead 14 and electrode cable 16 surface.
In described step S40C, it will be understood that described first securing member 182 can step S10 it
Front first it is sheathed on this extension lead 14, until step S40, mobile to this second barrel 1804
Upper.
In described step S50C, the mode heating described securing member 182 does not limits, as long as guaranteeing this fastening
Part 182 can uniformly penetrate heat.Described heating-up temperature is 45 DEG C～90 DEG C.
It is appreciated that described step S40C and S50C are optional step.Described step S40C
With in S50C, it is also possible to the most sheathed and shrink a securing member 182.If bindiny mechanism 18 only includes
Plural securing member 182, then can be the most sheathed and make its contraction distortion；Or it is the most sheathed
And contraction distortion.
Referring to Figure 14, second embodiment of the invention provides the implanted brain deep electricity of a kind of MRI compatible
Stimulator 10A, comprising: controller 12, extension lead 14, connects plug 15, electricity
Polar conductor 16 and a bindiny mechanism 18.
The implanted lesions located in deep brain device 10A of the MRI compatible that second embodiment of the invention provides and basis
The basic phase of structure of the implanted lesions located in deep brain device 10 of the MRI compatible that invention first embodiment provides
With, its difference is, the sleeve 180 of described bindiny mechanism 18 is helical form, and employing has biofacies
The conductive material that the elasticity of capacitive is good is made.The conduction that the described elasticity with biocompatibility is good
Material include but not limited to have the metal material such as platinum, platinum alloy of biocompatibility, iridium, iridium alloy,
Titanium, titanium alloy, rustless steel, Nitinol or cobalt-base alloys etc., and there is the carbon back of biocompatibility
Material or conducting high polymers thing etc..
Specifically, in the present embodiment, described sleeve 180 is Reducing screw spring structure.Employing has life
The conductive material that the elasticity of the thing compatibility is good processes.It is appreciated that at screw sheel 180 not
Same position, the line footpath d of described spring structure can not be unique.Preferably, can be at screw sheel 180
Two ends, suitably add big spring with the conductive shielding layer contact position of extension lead 14 and electrode cable 16
The line footpath d of structure, the most elastic to obtain, increase bindiny mechanism and extension lead 14 and electrode cable
The contact strength of the conductive shielding layer contact of 16.Preferably, the line footpath d in the middle part of described screw sheel 180
It is not to be exceeded 1 millimeter, excessive with the external diameter avoiding bindiny mechanism 18, it is difficult to implant.Described screw-casing
The length of cylinder 180 is more than the length of described connection plug 15.
Described screw sheel 180 is an inner surface and described implanted brain deep electricity thorn in its natural state
Swash the tubular structure that connecting portion 19 external surface shape of device 10 is consistent.As shown in figure 14, described spiral
Sleeve 180 is respectively provided with one identical with the shape of cross section of described connection plug 15 first in its natural state
The second barrel that barrel 1802, is identical with the shape of cross section of described extension lead 14
1804 and one threeth 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 institute
State the 3rd barrel 1806 to contact with the conductive shielding layer of described electrode cable 16 outer surface.Pass through spiral shell
Rotary sleeve 180, the conductive shielding layer of described extension lead 14 outer surface and described electrode cable 16 appearance
Electrical connection is formed between the conductive shielding layer in face.It is appreciated that when implanted lesions located in deep brain device uses
During structure as shown in Figure 6, described first barrel the 1802, second barrel 1804 and
The diameter of three barrel 1806 is the most identical with cross section.
It is appreciated that the shape of cross section of described screw sheel 180 structure in its natural state should be with institute
The shape of cross section stating connecting portion 19 is identical.Described screw sheel 180 internal diameter in its natural state
Size should be less than equal to the outside dimension of correspondence position on described connecting portion 19.When described screw sheel
Outside the internal diameter size of 180 structures in its natural state is less than with the correspondence position of described connecting portion 19
During the size of footpath, due to the supporting role of connecting portion 19, it is arranged on the screw sheel on connecting portion 19
The final structure of 180 is that the elastic contractile force of described screw sheel 180 reaches with the support force of connecting portion 19
Practical structures after balance, therefore, the size of the final structure of described screw sheel 180 will be greater than certainly
So size under state.Preferably, each cylinder of described screw sheel 180 structure in its natural state
The cross-sectional area S7 of shape part is less than the cross-sectional area S8 of the connecting portion 19 of its correspondence, and meets
Relation: (S8-S7)/S8 10%, to guarantee each cylindrical portion of the practical structures of described screw sheel 180
The outer surface dividing connecting portion 19 that can be corresponding fits tightly.When described sleeve 180 is at natural shape
When the internal diameter size of the structure under state is equal to the outside dimension of the correspondence position of described connecting portion 19, institute
State the structure under the final structure i.e. naturalness of screw sheel 180.
It is appreciated that before use, it is necessary to the structure of constraint helical casing cylinder 180.Spiral shell after this constraint
Rotary sleeve 180, before contraction distortion is final structure, should be greater than equal to described connection at its internal diameter minimum
The maximum outside diameter at position 19, in order to sheathed.For the ease of describing and understanding, this specification definition is described
The screw sheel 180 structure under constrained, shape and size are restraining structure.Preferably, described
The restraining structure of screw sheel 180 has homogeneous internal diameter, and the shape of cross section of its restraining structure is with described
The shape of cross section connecting plug 15 is identical, and internal diameter is more than the external diameter of described connection plug 15.
The mode of the restraining structure of the screw sheel 180 described in maintenance does not limits, as long as guaranteeing described screw-casing
Cylinder 180 stably maintains restraining structure, and can constraint relief easily in operation process.This
In inventive embodiments, as shown in figure 15, before surgery, first use a length more than screw sheel 180
Thin cylinder 183 screw sheel 180 is strutted.When operation, by described screw sheel 180 even
It is sheathed on described connecting portion 19 with described thin cylinder 183；By described thin cylinder 183 from spiral shell
Extract out in rotary sleeve 180, then described screw sheel 180 just can fit tightly due to elastic shrinkage in even
Connect the surface at position 19, and at two ends respectively with the conductive shielding layer of described extension lead 14 outer surface and
The conductive shielding layer of described electrode cable 16 outer surface contacts and forms electrical connection.
Described bindiny mechanism 18 farther includes two securing members 182.The fastening of described bindiny mechanism 18
Part 182 utilizes the elastic contractile force parts to being placed in ring direction around to produce certain normal pressure.
For the ease of understanding and describing, this securing member 182 is defined as elastic fastener 182 by this specification.
The structure that can realize elastic fastener 182 includes but not limited to helical spring structure and film cylinder knot
Structure.Being appreciated that in the present embodiment, described elastic fastener 182 should use described has life
The material that the material Elastic of the thing compatibility is good is made, and includes but not limited to platinum, platinum alloy, iridium, iridium
Alloy, titanium, titanium alloy, rustless steel, Nitinol, cobalt-base alloys and elastic good high molecular polymerization
Thing etc..The shape of cross section of described elastic fastener 182 structure in its natural state should be with described set
Second barrel 1804 and the 3rd barrel 1806 shape of cross section phase of the final structure of cylinder 180
With, described elastic fastener 182 internal diameter size in its natural state should be less than described sleeve 180
Second barrel 1804 and the outside dimension of the 3rd barrel 1806 cross section of final structure.Excellent
Selection of land, described elastic fastener 182 cross-sectional area S9 in its natural state is less than the institute of its correspondence
State the cross section S0 of the final structure of sleeve 180, and meet relation: (S0-S9)/S9 10%.Due to
The supporting role of the final structure of described sleeve 180, is arranged on the elastic fastener on connecting portion 19
The final structure of 182 is the elastic contractile force support force with connecting portion 19 of described elastic fastener 182
Reaching the practical structures after balance, therefore, the size of the final structure of described elastic fastener 182 will be big
The size of the structure under naturalness.It is appreciated that, due to elastic reaction, elastic fastener 182 will
Normal direction in the range of the parts being placed in ring around 360 ° is produced certain normal pressure, by institute
State the second barrel 1804 and the 3rd barrel 1806 is secured firmly to described extension lead 14 and electricity
On the screen layer of polar conductor 16 outer surface.
It is appreciated that before use, it is necessary to the structure of constraint elastic fastener 182, in contraction distortion
Before final structure, its internal diameter should be greater than equal to described second barrel 1804 and the 3rd barrel
The outside dimension of 1806 cross sections, in order to sheathed.For the ease of describing and understanding, this specification defines
The described elastic fastener 182 structure under constrained, shape and size are restraining structure.Preferably,
The restraining structure of described elastic fastener 182 has homogeneous internal diameter, the cross section shape of its restraining structure
Shape is identical with the shape of cross section of described connection plug 15, and internal diameter is more than the external diameter of described connection plug 15.
The mode of the restraining structure of the elastic fastener 182 described in maintenance does not limits, as long as guaranteeing described elasticity
Securing member 182 stably maintains restraining structure, and can constraint relief easily in operation process.
In the embodiment of the present invention, as shown in figure 15, before surgery, use a length more than elastic fastener
Elastic fastener 182 is strutted by the thin cylinder 185 of 182.When operation, by described elastic fastening
Part 182 is sheathed on described second barrel 1804 and the 3rd cylindrical portion together with described thin cylinder 185
Divide 1806；Described thin cylinder 185 is extracted out from sleeve 180, the most described elastic fastener 182
Just can fit tightly due to elastic shrinkage in described second barrel 1804 and the 3rd barrel 1806
Surface, described second barrel 1804 and the 3rd barrel 1806 are secured firmly to described in prolong
On the screen layer of long wire 14 and electrode cable 16 outer surface.
Referring to Figure 15, second embodiment of the invention further provides for the above-mentioned bindiny mechanism 18 of a kind of employing
The method that the conductive shielding layer of described extension lead 14 and electrode cable 16 outer surface is electrically connected.The party
Method comprises the following steps:
Step S10D: one end of described electrode cable 16 is inserted the socket 150 of described connection plug 15
In thus form a junction position 19；
Step S20D: use the length thin cylinder 183 more than screw sheel 180 by this spiral
Sleeve 180 struts, and together with described thin cylinder 183, described screw sheel 180 is sheathed on institute
State connecting portion 19；
Step S30D:；Described thin cylinder 183 is extracted out from screw sheel 180, makes described spiral shell
Rotary sleeve 180 is deformed into first barrel corresponding with described connection plug 15 due to elastic shrinkage
1802, second barrel electrically connected with the conductive shielding layer of described extension lead 14 outer surface
1804 and the 3rd barrel electrically connected with the conductive shielding layer of described electrode cable 16 outer surface
1806；
Step S40D: use the length thin cylinder 185 more than elastic fastener 182 by elasticity
Securing member 182 struts, and by described elastic fastener 182 together with described thin cylinder 185 respectively
It is sheathed on described second barrel 1804 and the 3rd barrel 1806；And
Step S50D: described thin cylinder 185 is extracted out from described elastic fastener 182,
Described elastic fastener 182 is made to fit tightly in described second barrel 1804 and due to elastic shrinkage
The surface of three barrel 1806.
It is appreciated that described thin cylinder 183 and thin cylinder 185 structure do not limit, as long as can prop up
The cylindrical body supportting described screw sheel 180 or described elastic fastener 182 is the most permissible.
Referring to Figure 16, third embodiment of the invention provides the implanted brain deep electricity of a kind of MRI compatible
Stimulator 10B, comprising: controller 12, extension lead 14, connects plug 15, electricity
Polar conductor 16 and a bindiny mechanism 18.
The implanted lesions located in deep brain device 10B of the MRI compatible that third embodiment of the invention provides and basis
The basic phase of structure of the implanted lesions located in deep brain device 10 of the MRI compatible that invention first embodiment provides
With, its difference is, the sleeve 180 of described bindiny mechanism 18 is caged, described bindiny mechanism 18
Securing member 182 is helical spring structure, and uses and have the conductive material that the elasticity of biocompatibility is good
Make.The conductive material that the described elasticity with biocompatibility is good includes but not limited to have biology
The metal material of the compatibility such as platinum, platinum alloy, iridium, iridium alloy, titanium, titanium alloy, rustless steel, NiTi
Alloy or cobalt-base alloys etc., and there are carbon-based material or the conducting high polymers thing etc. of biocompatibility.
Specifically, cage-like sleeve 180 includes two non-close rings be arrangeding in parallel and is arranged at this
Multiple bus between two non-close rings.The two ends of the plurality of bus be individually fixed in these two non-
In closed-loop.The fixed form used does not limits, the fixed form that can use include but not limited to welding,
Bonding etc..The plurality of bus and this non-close ring are collectively forming a cage structure.These two non-close
The opening of ring is located parallel on the same straight line of caged sleeve 180 axis, so that this caged sleeve 180
Form the non-close tubular structure of one side opening.Described caged sleeve 180 can be from non-close ring
Opening part is opened and is closed, thus this caged sleeve 180 is located at connecting portion 19.Described non-close
The material that ring uses the elasticity with biocompatibility good is made, the described bullet with biocompatibility
The good conductive material of property include but not limited to have biocompatibility metal material such as platinum, platinum alloy,
Iridium, iridium alloy, titanium, titanium alloy, rustless steel, Nitinol or cobalt-base alloys etc., and there is biology
The high molecular polymer etc. of the compatibility.It is appreciated that described non-close ring can also use and has biology
The material that the plasticity of the compatibility is good is made, and realizes changing opening and closing of caged sleeve 180 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
When connecting portion 19 is located at by this caged sleeve 180, the two ends of described bus are divided by described non-close ring
Be not pressed in described extension lead 14 outer surface and described electrode cable 16 outer surface conductive shielding layer
Outer surface on and form electrical connection.
In the present embodiment, described multiple bus can be soft conductive fiber, is attached to connect and inserts
On the surface of head, it is possible to for having the strip through bending of shape retentivity, so that this caged
Sleeve 180 have first barrel 1802 identical with the shape of cross section of described connection plug 15,
One identical with the shape of cross section of described extension lead 14 second barrel 1804 and one and institute
State the 3rd barrel 1806 that the shape of cross section of electrode cable 16 is identical.
Referring to Figure 17, fourth embodiment of the invention provides the implanted brain deep electricity of a kind of MRI compatible
Stimulator 10C, comprising: controller 12, extension lead 14, connects plug 15, electricity
Polar conductor 16 and a bindiny mechanism 18.
The implanted lesions located in deep brain device 10C of the MRI compatible that fourth embodiment of the invention provides and basis
The basic phase of structure of the implanted lesions located in deep brain device 10 of the MRI compatible that invention first embodiment provides
With, its difference is, it is thin that the sleeve 180 of described bindiny mechanism 18 and securing member 182 are elastic tubular
Film, and use the conductive material having the elasticity of biocompatibility good to make, such as, there is biofacies
The conducting high polymers thing of capacitive or conductive silicon rubber etc..
Be appreciated that described sleeve 180 just as balloon, shape in its natural state does not limits, but
Be be sheathed on connecting portion 19 after there is a shape consistent with connecting portion 19.In the present embodiment, institute
State and there is under sleeve 180 naturalness one first identical with the shape of cross section of described connection plug 15
The second barrel 1804 that shape part 1802, one is identical with the shape of cross section of described extension lead 14,
And threeth barrel 1806 identical with the shape of cross section of described electrode cable 16.Described tightly
Firmware 182 is two elastic rings.
The described elastic sleeve 180 of tubular membrane structure and the securing member 182 of elastic ring structure can use
The method of Figure 15 is attached.As long as be appreciated that have resilient sleeve 180 and securing member 182
The method of Figure 15 all can be used to be attached.
Referring to Figure 18, fifth embodiment of the invention provides the implanted brain deep electricity of a kind of MRI compatible
Stimulator 10D, comprising: controller 12, extension lead 14, connects plug 15, electricity
Polar conductor 16 and a bindiny mechanism 18.
The implanted lesions located in deep brain device 10D of the MRI compatible that fifth embodiment of the invention provides and basis
The basic phase of structure of the implanted lesions located in deep brain device 10 of the MRI compatible that invention first embodiment provides
With, its difference is, the sleeve 180 of described bindiny mechanism 18 and described extension lead 14 outer surface
Conductive shielding layer 146 is structure as a whole.
Specifically, described connection plug 15 is structure as a whole with described extension lead 14.Described connection machine
First barrel 1802 of the sleeve 180 of structure 18 is sheathed on this connection plug 15 outer surface, and the 3rd
It is outside that barrel 1806 then extends to this connection plug 15.When one end of described electrode cable 16 is inserted
After the socket 150 of this connection plug 15, the 3rd barrel 1806 can shrink and be fitted in institute
State on the conductive shielding layer 166 of electrode cable 16 outer surface.It is appreciated that described connection plug 15 also
Not can integrative-structure with described extension lead 14, as long as guaranteeing that the internal diameter of this sleeve 180 is more than this company
The external diameter of patch plug 15, or the internal diameter of this sleeve 180 can strut and be deformed into more than this connection plug 15
External diameter.
In the present embodiment, it is preferable that the sleeve 180 of described bindiny mechanism 18, described extension lead 14
The conductive shielding layer 146 of outer surface and the conductive shielding layer 166 of described electrode cable 16 outer surface are
Use and there is the network structure that the marmem of biocompatibility is compiled into.Described bindiny mechanism 18
Sleeve 180 once work out with described conductive shielding layer 146.The sleeve of described bindiny mechanism 18
180 process through shape memory, have memory structures.
Referring to Figure 19, sixth embodiment of the invention provides the implanted brain deep electricity of a kind of MRI compatible
Stimulator 10E, comprising: controller 12, extension lead 14, connects plug 15, electricity
Polar conductor 16 and a bindiny mechanism 18.
Sixth embodiment of the invention provide MRI compatible implanted lesions located in deep brain device 10E with this
The basic phase of structure of the implanted lesions located in deep brain device 10D of the MRI compatible that bright 5th embodiment provides
With, its difference is, the sleeve 180 of described bindiny mechanism 18 and described electrode cable 16 outer surface
Conductive shielding layer 166 is structure as a whole.
Specifically, described connection plug 15 is structure as a whole with described electrode cable 16.Described connection machine
First barrel 1802 of the sleeve 180 of structure 18 is sheathed on this connection plug 15 outer surface, and second
It is outside that barrel 1804 then extends to this connection plug 15.When one end of described extension lead 14 is inserted
After the socket 150 of this connection plug 15, this second barrel 1804 can shrink and be fitted in institute
State on the conductive shielding layer 146 of extension lead 14 outer surface.It is appreciated that described connection plug 15 also
Not can integrative-structure with described electrode cable 16, as long as guaranteeing that the internal diameter of this sleeve 180 is more than this company
The external diameter of patch plug 15, or the internal diameter of this sleeve 180 can strut and be deformed into more than this connection plug 15
External diameter.
In the present embodiment, it is preferable that the sleeve 180 of described bindiny mechanism 18, described extension lead 14
The conductive shielding layer 146 of outer surface and the conductive shielding layer 166 of described electrode cable 16 outer surface are
Use and there is the network structure that the marmem of biocompatibility is compiled into.Described bindiny mechanism 18
Sleeve 180 once work out with described conductive shielding layer 166.The sleeve of described bindiny mechanism 18
180 process through shape memory, have memory structures.
As shown in figure 20, the implanted lesions located in deep brain device 10 of MRI compatible of the present invention is being answered
Described extension lead 14 and electrode cable 16 are first implanted human body different parts by the used time respectively, then use
Described extension lead 14 and electrode cable 16 are connected by connecting portion.The bindiny mechanism 18 of the present invention is permissible
Extension lead 14 is connected with the conductive shielding layer on electrode cable 16, it is ensured that screen layer is to stimulation
RF pyrogenicity temperature rise at contact has good inhibition.Operation is installed by the bindiny mechanism 18 of the present invention
Simple and fast, uniform force, connect reliable.
It addition, those skilled in the art can also do other changes in spirit of the present invention, these are according to this
The change that spirit is done, all should be included in scope of the present invention.
Claims (16)
1. an implantable medical devices for MRI compatible, comprising:
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 connects plug, and described connection plug is used for connecting this extension lead and electrode cable thus forms one
Connecting portion；And
One bindiny mechanism, described bindiny mechanism includes that an employing has the marmem of biocompatibility
The shroud sleeve made, this shroud sleeve has an initiating structure, and this shroud sleeve is through shape memory
Heat treatment has memory structures so that this shroud sleeve be heated reach transition temperature time contraction distortion become
Being a tubular structure consistent with described connecting portion external surface shape, this tubular structure is for prolonging described
The conductive shielding layer of long wire outer surface is electrically connected with the conductive shielding layer of described electrode cable outer surface
Connect.
2. the implantable medical devices of MRI compatible as claimed in claim 1, it is characterised in that described screen
The shape of cross section of the initiating structure covering sleeve is identical with the shape of cross section of described connection plug；And institute
State the cross-sectional area S3 and the described cross-sectional area S4 being connected plug of the initiating structure of shroud sleeve
Meet relation: (S3-S4)/S4 10%.
3. the implantable medical devices of MRI compatible as claimed in claim 1, it is characterised in that described screen
Covering sleeve is a monolayer network structure, and it uses the marmem with biocompatibility to make
Fibrage forms.
4. the implantable medical devices of MRI compatible as claimed in claim 3, it is characterised in that described tool
There is the diameter of the fiber that the marmem of biocompatibility makes more than or equal to 0.02 millimeter and little
In equal to 0.2 millimeter.
5. the implantable medical devices of MRI compatible as claimed in claim 1, it is characterised in that described screen
Cover the transition temperature of sleeve between 45 DEG C～90 DEG C.
6. the implantable medical devices of MRI compatible as claimed in claim 1, it is characterised in that described tool
The marmem having biocompatibility is Ti-Ni marmem.
7. the implantable medical devices of MRI compatible as claimed in claim 1, it is characterised in that described screen
The memory structures covering sleeve have first tubular identical with the shape of cross section of described connection plug
Partly, second barrel identical with the shape of cross section of described extension lead and one and institute
State the 3rd barrel that the shape of cross section of electrode cable is identical.
8. the implantable medical devices of MRI compatible as claimed in claim 7, it is characterised in that described screen
The shape of cross section that the shape of cross section of the memory structures covering sleeve is corresponding with described connecting portion is identical；
And the cross-sectional area S1 of each barrel of the memory structures of described shroud sleeve is corresponding less than it
The cross-sectional area S2 of connecting portion, and meet relation: (S2-S1)/S2 10%.
9. the implantable medical devices of MRI compatible as claimed in claim 1, it is characterised in that described in prolong
The conductive shielding layer of long wire outer surface and the conductive shielding layer of described electrode cable outer surface all use
The marmem with biocompatibility is made；And outside described shroud sleeve is with described extension lead
The conductive shielding layer on surface is structure as a whole, or described shroud sleeve and described electrode cable outer surface
Conductive shielding layer is structure as a whole.
10. the implantable medical devices of MRI compatible as claimed in claim 1, it is characterised in that described company
Connection mechanism further comprises the shape memory alloy material that two employings have biocompatibility and makes
Dead ring；Described dead ring is sheathed on described tubular structure when using；Described dead ring is through shape
Shape memory heat treatment has memory structures so that this dead ring is received when being heated and reaching transition temperature
Contracting, thus this tubular structure is securely fastened to the outer surface of connecting portion.
The implantable medical devices of 11. MRI compatible as claimed in claim 10, it is characterised in that described
Dead ring is annular wafer, and the thickness of thin slice is 0.1 millimeter～0.5 millimeter, and width is 2 millimeters～8
Millimeter.
The implantable medical devices of 12. MRI compatible as claimed in claim 10, it is characterised in that described
The cross-sectional area S5 of the memory structures of dead ring is less than the cross-sectional area of the tubular structure of its correspondence
S6, and meet relation: (S6-S5)/S6 10%.
The implantable medical devices of 13. 1 kinds of MRI compatible as according to any one of claim 1 to 12
Method of attachment, the method comprises the following steps:
Use described connection plug to connect described electrode cable and extension lead thus form this connecting portion；
Described shroud sleeve is sheathed on this connecting portion；And
Heating described shroud sleeve makes its contraction distortion become first cylindrical portion corresponding with described connection plug
Point, second barrel electrically connected with the conductive shielding layer of described extension lead outer surface, Yi Jiyi
The 3rd barrel electrically connected with the conductive shielding layer of described electrode cable outer surface.
The method of attachment of the implantable medical devices of 14. MRI compatible as claimed in claim 13, its feature
It is, further includes steps of
One first dead ring is sheathed in this second barrel, and one second dead ring is sheathed on this
In 3rd barrel；And
Heating makes described first fastening and the second dead ring contraction distortion.
The method of attachment of the implantable medical devices of 15. MRI compatible as claimed in claim 14, its feature
Being, the temperature of described heating shroud sleeve, the first dead ring and the second dead ring is 45 DEG C～90 DEG C.
16. 1 kinds of bindiny mechanisms for the implantable medical devices of MRI compatible, it is characterised in that this connection
Mechanism includes that an employing has the shroud sleeve and two that the marmem of biocompatibility is made
Individual employing has the dead ring that the shape memory alloy material of biocompatibility is made；This shroud sleeve has
There is an initiating structure, and this shroud sleeve have memory structures through shape memory heat treatment so that
This shroud sleeve be heated reach transition temperature time contraction distortion become one and lead with extension lead and electrode
The tubular structure that the connecting portion external surface shape of line is consistent, this tubular structure is for leading described prolongation
The conductive shielding layer of line outer surface electrically connects with the conductive shielding layer of described electrode cable outer surface；Described
Dead ring is sheathed on tubular structure when using；Described dead ring has one through shape memory heat treatment
Memory structures so that this dead ring shrinks when being heated and reaching transition temperature, thus by this tubular structure
It is securely fastened to the outer surface of connecting portion.
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| CN108808313B (en) * | 2018-07-06 | 2019-12-13 | 清华大学 | connecting mechanism of implantable medical device, implantable medical device and connecting method |
| CN109541511B (en) * | 2018-11-26 | 2020-02-14 | 清华大学 | Temperature rise prediction method and device |
| CN110691549B (en) * | 2019-07-17 | 2022-07-22 | 诺尔医疗（深圳）有限公司 | Intracranial deep electrode |
| CN110520042B (en) * | 2019-07-17 | 2022-05-03 | 诺尔医疗（深圳）有限公司 | Intracranial deep electrode |
| CN112190835B (en) * | 2020-09-17 | 2023-04-07 | 北京品驰医疗设备有限公司 | Connecting mechanism of implantable medical device and manufacturing method thereof |
| CN114125114B (en) * | 2021-11-01 | 2024-05-14 | 维沃移动通信有限公司 | Acoustic module and electronic equipment |
| CN116099125B (en) * | 2023-02-15 | 2024-08-16 | 微智医疗器械有限公司 | Electrode structure of electric stimulator and electric stimulator |
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| CN101039619A (en) * | 2004-08-09 | 2007-09-19 | 约翰斯·霍普金斯大学 | Implantable mri compatible stimulation leads and antennas and related systems and methods |
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| CN101039619A (en) * | 2004-08-09 | 2007-09-19 | 约翰斯·霍普金斯大学 | Implantable mri compatible stimulation leads and antennas and related systems and methods |
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