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CN102481449A - Electrical neurostimulator package - Google Patents

Electrical neurostimulator package Download PDF

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Publication number
CN102481449A
CN102481449A CN2010800055911A CN201080005591A CN102481449A CN 102481449 A CN102481449 A CN 102481449A CN 2010800055911 A CN2010800055911 A CN 2010800055911A CN 201080005591 A CN201080005591 A CN 201080005591A CN 102481449 A CN102481449 A CN 102481449A
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CN
China
Prior art keywords
coil
cage
equipment according
container
equipment
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CN2010800055911A
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Chinese (zh)
Inventor
雅努什·A·库茨马
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NEUROSTIMULATION DEVICES AND T
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NEUROSTIMULATION DEVICES AND T
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Priority claimed from AU2009900289A external-priority patent/AU2009900289A0/en
Application filed by NEUROSTIMULATION DEVICES AND T filed Critical NEUROSTIMULATION DEVICES AND T
Publication of CN102481449A publication Critical patent/CN102481449A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/3752Details of casing-lead connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36036Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
    • A61N1/36038Cochlear stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37217Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223Circuits for electromagnetic coupling
    • A61N1/37229Shape or location of the implanted or external antenna

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Acoustics & Sound (AREA)
  • Electromagnetism (AREA)
  • Prostheses (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Described herein is technology relevant to the field of implantable electrical neurostimulators. For example, embodiments include but are not limited to cochlear implants, implantable hearing aids, deep brain stimulators and pain control devices, as well as constituent components of such devices, methods for their manufacture, and methods for their use. For the present purposes, embodiments are described particularly by reference to exemplary cochlear implants, although that should not be regarded as necessarily limiting on the underlying concepts.

Description

The electro-neural stimulator instrument encapsulation
Technical field
Present invention relates in general to field of medical, wherein embodiment relates to the field of implantable electro-neural stimulator instrument.For example embodiment includes but not limited to the building block of cochlear implant, implantable sonifer, DBS device and pain control appliance and these equipment, their manufacturing approach and their method for using.
Background technology
The discussion of following background technology is intended to the present invention is placed suitable situation, and allows its unique characteristic and advantage more to be made much of.Yet any discussion to background technology in the whole description should not be considered to approval following clear and definite or hint: promptly this prior art is well known in the art, and has perhaps formed the part of general knowledge known in this field.
In nerve stimulator design aspect (for example in the situation at cochlear implant), reliability requirement has advanced the restriction of manufacturing technology.United States Patent(USP) No. 5,105,811 with United States Patent(USP) No. 5,562,7101 in this example of equipment has been described.
The design of most nerve stimulator is promptly made closed type metal or the ceramic capsule that is equipped with a plurality of sealed electrical feedthrough components based on such notion, and said sealed electrical feedthrough component is used between the inner space of capsule and surrounding, the signal of telecommunication being imported into or spreading out of.
In in the past 20 years, formed be used for multichannel output nerve stimulator, especially for the industrial standard of cochlear implant.Especially, main capsule is processed by the biocompatible metals such as titanium, and the multiconductor feedthrough component provides internal circuit, stimulate being connected between the wiring of lead-in wire and exterior antenna loop, is used for data and power delivery.
Be the desired reliability of this equipment that guarantees to be designed to sometimes in effect duration, to move, and for provide a kind of size very little, have equipment based on ergonomic shape, this design and fabrication technology is complicated and challenging especially.
Summary of the invention
The objective of the invention is to overcome or improve at least one shortcoming of prior art, or provide substituting of usefulness.
An embodiment provides a kind of implantable devices, and this implantable devices comprises:
By the first that flexible, non-conducting material form, first holds one or more conductive coils;
Be couple to the second portion in the first, second portion comprises rigid container, is defined for the chamber that keeps treatment circuit in the rigid container; And
Be couple to the electrode assemblie on the second portion, electrode assemblie comprises the longitudinal bodies of extension away from first and second portion, and wherein, electrode assemblie is couple on the treatment circuit.
An embodiment provides a kind of equipment, and wherein second portion comprises base portion and the top that is separated by sidewall, and wherein, a plurality of feedthrough components form through sidewall to be used to allowing wiring between first and second portion, to pass.
An embodiment provides a kind of equipment, and wherein, first contacts with the exterior section of feedthrough component.
An embodiment provides a kind of equipment that comprises rigid cage, and rigid cage is fixedly secured on the second portion, and rigid cage comprises first is mechanically secured to the configuration on the second portion.
An embodiment provides a kind of equipment, and wherein cage is welded on the second portion.
An embodiment provides a kind of equipment, and wherein cage and second portion form.
An embodiment provides a kind of equipment, and wherein cage comprises one group of cage member, and one group of cage member is positioned to be defined for first is fixed to the window on the cage.
An embodiment provides a kind of equipment, and wherein first forms through molding process, thus, but the moulding material that limits first substantially flow through window and flow in the cage, thereby with respect to the fixing first of second portion.
An embodiment provides a kind of equipment, and wherein electrode assemblie is couple on the treatment circuit through feedthrough component.
An embodiment provides a kind of equipment, and wherein rigid container is configured for protecting at junction point between electrode assemblie and the second portion, on the equipment downside and avoids downward impact.
An embodiment provides a kind of equipment, and wherein electrode assemblie is installed on the second portion in the position of the lower surface of second portion or in the position of the lower surface that is close to second portion, and wherein above-mentioned position is upcountry spaced apart from the periphery of second portion.
An embodiment provides a kind of equipment, and wherein above-mentioned position is in the center basically with respect to the lower surface of second portion.
An embodiment provides a kind of equipment, and wherein rigid container is metal, and electrode assemblie is an electric insulation with respect to rigid container.
An embodiment provides a kind of equipment, and this equipment comprises the power delivery loop, and the power delivery loop comprises:
The multi cord coil; With
Around the chamber of said coil, wherein, said chamber is processed by the elastoplast pipe.
An embodiment provides a kind of equipment, and this equipment comprises ground electrode, and this ground electrode comprises the circular metal dish, and wherein the top surface of this dish and connecting band expose, and the edge of this dish and lower surface are insulating.
An embodiment provides a kind of equipment, and wherein rigid container is metal, and ground electrode is installed in the recess in the outer surface that is formed at rigid container.
An embodiment provides a kind of method that is used to form implantable devices, and said method comprises:
Rigid container is provided, is defined for the chamber that keeps treatment circuit in this rigid container, wherein, rigid container comprises the feedthrough assembly, and this feedthrough assembly is used to allow wiring between the parts of treatment circuit and external container, to pass, and this feedthrough assembly is protected by cage;
Processing unit is connected on the parts of external container through the feedthrough assembly, the parts of this external container comprise electrode assemblie and coil;
Through using molding process to limit in order to hold the flexible alar part of coil, wherein, flexible alar part extends in the cage, thereby alar part is mechanically connected on the container.
An embodiment provides a kind of implantable devices, and this implantable devices comprises:
Rigid container is defined for the chamber that keeps treatment circuit in this rigid container, wherein, rigid container comprises the feedthrough assembly, and this feedthrough assembly is used to allow wiring between the parts of treatment circuit and external container, to pass, and wherein said feedthrough assembly is protected by cage;
Be positioned at the parts of external container, the parts of this external container are couple on the processing unit through the feedthrough assembly, and wherein the parts of this external container comprise electrode assemblie and coil;
In order to hold the flexible alar part of coil, wherein, flexible alar part forms through molding process, and extends in the cage, thereby alar part is mechanically connected on the container.
An embodiment is provided for the power delivery loop of implantable devices, and this power delivery loop comprises:
The multi cord coil; With
Around the chamber of said coil, wherein, said chamber is processed by the elastoplast pipe.
An embodiment provides the method for the power delivery loop that is formed for implantable devices, and said method comprises:
The multi cord coil is provided; With
Coil is encapsulated into the elastoplast intracavity, thereby limits the coil of encapsulation;
With the encapsulation coil heats to more than the predetermined temperature;
With the coil molding of encapsulation is intended shape; And
Allow the coil cooling of encapsulation, make the coil of encapsulation be set at intended shape.
Run through " embodiment ", " some embodiments " or " embodiment " quoted in this description, the meaning is: combine concrete characteristic, structure or the characteristics of embodiment explanation to be included at least one embodiment of the present invention.Thus, the phrase " embodiment ", " some embodiments " or " embodiment " that occur throughout in the whole description need not to be and all refer to same embodiment, but also may all refer to same embodiment.In addition,, will be apparent that in one or more embodiments, concrete characteristic, structure or characteristics possibly combine with the mode that is fit to arbitrarily to those of ordinary skills according to the disclosure.
Likewise; Should be understood that in the exemplary embodiment of the invention of above explanation, various characteristics of the present invention are combined in single embodiment, accompanying drawing or its explanation sometimes together; So that the disclosure simplification, and help to understand one or more different novelty aspects.Yet the method in the present disclosure is not interpreted as the following purpose of reflection, and promptly the present invention for required protection requires than the more characteristic of the characteristic of specifically quoting in every claim.On the contrary, like that claim reflects enclosed, the novelty aspect is to be less than all characteristics of single aforementioned open embodiment.So, specially will be incorporated in the explanation of this specific embodiment at this with the appended claim of the description of the specific embodiment, wherein, every claim is all separately as the present invention's embodiment independently.
In addition; Though some embodiments of describing among this paper include only some characteristics; And do not comprise other characteristics that comprise in other embodiments, still, as understood by one of ordinary skill in the art; The combination of the characteristic of different embodiments is intended to fall into scope of the present invention, and forms different embodiment.For example, in accompanying claims, any one can be used with combination arbitrarily in the embodiment required for protection.
In addition, in this article, some embodiments are described as the combination of each key element of processor or method of implementing through other equipment of carrying out said function or method that can be through computer system.Therefore, the processor that has a necessity instruction that is used to carry out this method or method key element has formed the device that is used to carry out this method or this method key element.In addition, be to realize the present invention, the key element of describing in this article of equipment embodiment is the example that is used to carry out the device of the said function that is realized by said key element.
In the description that this paper provided, many concrete details have been set forth.Yet be understood that: embodiment of the present invention can be implemented under the situation of these details not having.In other example, be not shown specifically well-known method, structure and technology, not obscure understanding of this description.
As used herein; Only if other special explanations are arranged; Use the common objects of descriptions such as ordinal number adjective " first ", " second ", " the 3rd " only to represent to relate to the different examples of analogical object, and and be not intended to object that hint describes like this must be in the time upward, on the space, on the grade or the particular order of any alternate manner.
In this paper accompanying claims and description, term " comprises ", " including " or in " it comprises " any one are open terms, and the meaning is the elements/features that comprises at least subsequently, but does not get rid of other elements/features.Thus, when in claim, using a technical term " comprising ", should not be interpreted as restriction to device, element or the step of listing subsequently.For example, the expression scope of " equipment that comprises A and B " should not be restricted to the equipment of only being made up of element A and B.The term that uses in this article " comprises ", in " it comprises " or " it comprises " any one is open term, and the meaning is to comprise the elements/features of following this term at least, but does not get rid of other elements/features.Therefore " comprise " and " comprising " is synonym, and expressed equivalent in meaning.
Similarly, term " couples " when using in this article, should only not be interpreted as and only be limited to direct connection." coupling " and " connection " and their derivative together can use a technical term.The expression scope that " is couple to the device A of equipment B " should not be limited to such equipment or system, that is, the output of device A is directly connected to the input of equipment B.Its meaning is between the input of the output of A and B, to have the path, and this path possibly be the path that comprises miscellaneous equipment or device." couple " and can mean that two or more elements are in direct physical contact or electrically contact, though perhaps two or more element directly do not contact each other, but still be fitted to each other or interact.
Description of drawings
Referring now to accompanying drawing, only preferred implementation of the present invention is described through example, wherein:
Figure 1A provides the isometric front view according to the equipment of an embodiment.
Figure 1B provides the perspective rear view of the equipment of Figure 1A.
Fig. 2 provides the axonometric chart of partly cut-away of housing parts of the equipment of Figure 1A, shows one group of closed type electricity feedthrough component.
Fig. 3 A provides the decomposition isometric front view of the equipment of Figure 1A.
Fig. 3 B provides the decomposition isometric front view of the equipment of Figure 1A.
Fig. 4 illustrates the equipment of the Figure 1A under the local structure state.
Fig. 5 A provides the vertical view of Figure 1A equipment.
Fig. 5 B provides along the profile of the line B-B of Fig. 5 A.
Fig. 5 C provides the more detailed view in the zone of Fig. 5 B, shows the wiring to feedthrough component.
Fig. 6 A provides the axonometric chart according to the electrode assemblie of an embodiment.
Fig. 6 B provides the perspective, cut-away view of the electrode assemblie shown in Fig. 6 A.
Fig. 7 A and Fig. 7 B have demonstrated according to the structure of the Low ESR coil of an embodiment.
Fig. 8 provides the axonometric chart according to the parts of an embodiment, and these parts provide the coil alar part for the equipment of Figure 1A.
The specific embodiment
The technology that relates to implantable electro-neural stimulator instrument field described herein.For example, embodiment includes but not limited to cochlear implant, implantable sonifer, deep brain pacemaker and pain control appliance, and the building block of these equipment, their manufacturing approach and their method for using.For this purpose, the exemplary cochlear implant of special reference is explained embodiment, and this should not be considered to necessity restriction to basic conception.
Situation roughly
Embodiment of the present invention is intended to be specially adapted to wait that the mode that is implanted to the lip-deep stimulator of human skull improves design, reliability and other factors.The best example of these equipment is cochlear implant, implantable sonifer, deep brain pacemaker and like the peripheral nerve stimulation device of migraine suppression equipment and so on.Consider that the equipment that is positioned at skull surface bears very big mechanical stress, the inventor has been noted that variety of issue, and still there is significant challenge in these problems and still improbably fully overcomes through existing design or technology.These problems comprise:
Make equipment (but still possessing enough inner spaces) acceptable, low profile with holding electronic equipment; Said equipment is maintained at settling position; And if the loss to sealing has elasticity when suffering mechanical shock, adequately protect thereby internal circuit provided.
Be provided to effectively and reliably to connect to give and stimulate lead-in wire or pick off.
For external power and communication antenna coil provide the mechanical robustness protection, thereby keep its electrical characteristics as well as possible.
The design and fabrication technology of hereinafter describing provides effective solution for some embodiments having under the situation of these challenges, thereby provides shape to be suitable for being placed on the high reliability equipment of adult and child's height of head.
Device overview
Described in this article embodiment relates to the design and fabrication technology of implantable, sealed package of the electro-neural stimulator instrument of (RF) power that is used to have radio frequency and data communication facility.Through with reference to shown in each figure, form is that the sealed package type equipment of equipment 10 is explained embodiment.Equipment 10 is particularly suitable for the nerve stimulator of cochlear implant, implantable sonifer and other implantation heads.
It seems that totally equipment 10 is the equipment of general planar, its visually/conceptively limit three parts: rigid seal container 11, said rigid seal container 11 holds processing unit; Flexible alar part 70, said flexible alar part 70 holds the telemetry coil of embedding; And electrode assemblie 20, said electrode assemblie 20 is configured to nerve stimulation.Each importance of equipment 10 will further be discussed following, comprise:
Total structure and manufacturing approach.
Reliable feedthrough assembly.
Electrode below the equipment connects.
The structure of ground electrode.
Structure/the formation of coil.
Will be understood that: each of these aspects all can provide corresponding advantages for equipment 10.Yet similarly, will be understood that: not every these aspects all are present in all embodiments; Each embodiment comprises some key characters of equipment 10, and does not comprise other key characters.
Total structure and manufacturing approach
Detailed description is used to form the illustrative methods of equipment 10 with the lower part.This method provides as the introduction of each parts of equipment 10 basically, and from the building method angle, should not think restriction.In addition, each step can be carried out successively, rather than is undertaken by mode illustrated among this paper.Fig. 3 A and Fig. 3 B show the exploded view of equipment 10.Two figure all show the reference location of all critical pieces, and show crucial assembling process.
Container 11 is defined for to hold and handles the chamber that equipment (for example one or more printed circuit board (PCB)) waits and be the similar chamber that equipment 10 provides the nerve stimulation function.The characteristic of this processing equipment has been left in the basket owing to present disclosure basically, and is somebody's turn to do the concrete application of the feature of handling equipment and difference.In this article, container 11 comprises upper shell 100 and lower house 120, and upper shell 100 and lower house 120 are welded together between them, to limit the chamber.In this embodiment, upper shell is basic to work as the open containers with sidewall, and lower house is smooth substantially and conduct is used so that the lid of the seal of vessel of upper shell.Yet, in other embodiments, use replaceable structure to limit this canister.The effect of sealing canister is to protect the sensitive electronic circuit in the inner space that is contained in gas-tight seal to avoid the destruction of body fluid, and mechanically protects the perishable distribution connection of feedthrough component output.
Preferably, housing 100 is processed by the solid piece such as the metalloid of titanium or titanium alloy.The tapered edge of housing 100 is attached under the skin through the profile with this equipment, comes for this equipment provides based on ergonomic profile, and makes the distortion that the structure of this equipment is hard and impact head is to external world caused have elasticity simultaneously.
Container 11 comprises the sidewall that is equipped with one group of sealed electrical feedthrough component 101, shown in the best in Fig. 2, these feedthrough component integral body are called as feedthrough assembly 15.Said feedthrough assembly is that a plurality of holes of feedthrough component 101 limit form, and these holes extend through the sidewall of container 11 and get into alar part 70.Feedthrough component 101 is positioned at makes on the sidewall of housing 100 and can form big open spaces 105 with ccontaining internal circuit in that metal shell is inner, but it also contains the integral thickness of equipment.Feedthrough assembly 15 allows to be wired to the parts (for example being wired to telemetry coil and electrode assemblie) outside the chamber from the parts of intracavity.The side section that this structure allows under the situation that does not increase the equipment integral thickness, to comprise responsive feedthrough component 100 is more thickeied, and has more elasticity for damage.
Assembling starts from circuit arrangement and the inside feedthrough outfan that is connected to feedthrough component 101.Through they being sealed welding and sealed container 11 along upper shell 100 and lower house 120 edge separately.
Process recess 103 at the top of housing 100, with ccontaining ground electrode assembly 30 in settling position.Electrode assemblie 30 is fixed to the bottom of recess with agglutinating mode and selectively keeps in place through the independent becket that is welded to the recess edge.Ground electrode assembly 30 in use directly towards cover implant, power provides the skin of limited protection to external world, on this meaning, above set-up mode is favourable.In manufacture process, ground electrode assembly 30 is fixed in the recess 103, and ground electrode assembly 30 is connected to its each feedthrough component (or a plurality of feedthrough component).
With regard to manufacturing, after wiring connected, ground electrode assembly 30 was fixed in the housing recess 103, and connecting band 33 is welded in the feedthrough component 101 corresponding one.Next step, power coil 50 and data coil 60 are connected in the feedthrough component 101 corresponding one.Then feedthrough cage 90 is placed feedthrough component (and be connected to feedthrough component arrange parts of the 101) top of arranging 101, and feedthrough cage 90 is connected to the edge of housing 100 anterior recesses through spot welding, as shown in the figure.
Then, electrode assemblie 20 is connected to their corresponding outside feedthrough component outfans with the wiring of telemetry coil 50 and 60.At this moment, accomplished wiring to equipment 10.
Next step of structure equipment 10 is that feedthrough cage 90 is placed feedthrough assembly 15 tops (and in some embodiments, at distribution elder generation's location feedthrough before cage, for example in these embodiments, the hole in the feedthrough cage is passed in wiring).This feedthrough cage is connected to container 11 through spot welding, promptly is connected to housing 100 or housing 120, perhaps be connected to housing 100 and housing 120 through spot welding simultaneously through spot welding.In some embodiments, cage 90 and housing 110 or housing 120 integrated formation, perhaps the two is integrally formed with housing 110 and housing 120.Cage 90 is constructed to provide following two kinds of key functions:
Protection feedthrough assembly 15.Cage 90 comprises protectiveness upper surface 91, and this protectiveness upper surface 91 is protected the accurate wiring exit point of feedthrough assembly 15 through the lid that covers on the rigidity is provided.
Alar part 70 is connected to container 11.Cage 90 comprises one group of cage member, and in this article, said cage member is to be connected to the lower horizontal member that therefore upper surface 91 also limits window 92 through a plurality of stays.To further discuss as following, these members allow fixedly alar part 70.
Next be that cage 90 is installed, bottom 110 is positioned over the top of electrode assemblie 20 and is connected on the housing 120 through spot welding.The characteristic of lid 110 provides multiple favourable function, and these will be discussed further following.
At last, as shown in Figure 4, comprise that the black box of magnet 80 is arranged in the inside of pressing mold, liquid polymers (like silicone rubber or analog) is injected filling up die cavity, thereby form alar part 70.Flexible alar part 70 remains on stable qualification position with telemetry coil 50,60 and magnet assembly 80.A very important details of this process is: liquid polymers flows through cage 90 forward windows, thereby between the seal closure assembly of alar part and container 11, forms firm mechanical bond.That is to say that the liquid polymers that forms alar part 70 flows into cage 90, thereby alar part 70 is fixed on the container 11.In addition, said polymer flows around feedthrough assembly 15, thus the protection distribution, and said polymer moieties ground inflow feedthrough component 101, thereby auxiliary seal.
Fig. 5 A, Fig. 5 B and Fig. 5 C illustrate in greater detail the final position fixing process that all parts are in the end assembled the stage, and the process that forms aerial coil 70.What specifically illustrate among Fig. 5 C is the connection of electrode assemblie wiring 21 to feedthrough component 101, and the mechanical engagement of alar part 70 and cage 90.The important basic point of this embodiment is: the edge that lid 110 overhangs housing 100, thus form clear passages to feedthrough component 101 for wiring 21.This has formed effective mechanical protection for perishable in essence wiring 21.Simultaneously, when being positioned over skull when getting out in the portion (drillout), very tangible columniform lid 110 plays fixation for implant.
Compliant member is connected with rigid element
In the stimulator structure of the type, a great challenge provides reliable mechanical connection between flexible alar part 70 and hard canister 11.This connection is for getting into 90 times side spaces of cage and being connected to the telemetry coil 50 of corresponding feedthrough component and 60 connection integrity is important.Conventional method is that the alar part material is spread all over hard metal cap and as main overmolded layer.Though this method has been improved the combination between said two parts, this method has also increased the integral thickness and the bottom of equipment, and this is real defective.
In the technology disclosed herein, of previous section, this connection is sent in 90 times side spaces of cage via cage 90 forward group window groups through the polymer that will be used to form alar part 70 and realizes.This provides good mechanical connection under the situation that does not increase the implant size.As stated, the selectivity that particular importance step is a black box in the assembling of equipment 10 coats molded, to form coil alar part 70 as shown in Figure 8.The implant assembly that this process relates to whole local structure is positioned over mould intracavity portion.Then liquid polymers is injected this instrument.This instrument is so shaped that polymer formation antenna alar part 70; The space that said polymer is filled in the cage 90 via window 92; And through covering 110 extension, fill the chamber, lead-in wire is fixed therein.
Under the situation of this embodiment, the effect of the window 92 in the cage 90 is particular importances.These perforation provide fixed form very efficiently for antenna alar part 70 to said shade assembly, and have therefore eliminated housing 100 is carried out the molded necessity that keeps with the abundant machinery that the antenna alar part is provided of traditional big outside coating.And the molded size that also can increase implant greatly of such coating.
Fig. 5 shows in detail the design principle that wiring 21 is connected to feedthrough component 101.The end of lead assemblies is positioned near the edge of the housing that comprises 101 groups of feedthrough components.Wiring 21 is sent to feedthrough component and is fused to corresponding feedthrough component pin.After wiring connects, sacrificial metal lid 110 is positioned over the top of lead-in wire end, and will covers 110 through spot welding and be connected to bottom 120.
Electrode below the equipment connects
Notice that like preceding text electrode assemblie 20 draws from container 11 through covering 110, said lid 110 is positioned on the downside of equipment 10 and away from the periphery of this equipment.In this way, the connection of electrode and the point of drawing are avoided impact failure through the protection of rigid container 11.That is to say that the location of lid 110 provides the electrode link position, this electrode link position is avoided the mechanical stress via the outer covering layer transmission of skin by the overhanging partial protection of container 11.This is different from (and having improved widely) known equipment, and electrode assemblie is drawn from periphery usually in said known equipment.
In this article, bottom 110 is configured to get out the fixing short column of equipment in the portion as embed skull with fixed form.This permission equipment 10 is located with respect to skull reliably.In addition, cover the lead-in wire entering tympanum of 110 lead electrode assemblies 20.
The important basic point of another of this embodiment is that lid 110 stretches out the edge of housing 100, thereby forms the clear passage of wiring 21 to feedthrough component 101.This has formed effective mechanical protection for perishable in essence wiring 21.
The structure of ground electrode
Building method according to the ground electrode assembly 30 of an embodiment has been shown among Fig. 6 A and Fig. 6 B.Generally, circular metal dish 31 molded forming in plastic pattern 32 of preferably processing, preferably molded forming in " polyether-ether-ketone " by platinum foil.Polyether-ether-ketone is because therefore its good mechanical strength (high more a lot of than the employed gold of coil structure), good insulation performance characteristic and bio-compatibility are preferable material.
As shown in the figure, the end face of platinum dish 31 and connecting band 33 remain exposure.The edge of this dish and bottom are insulating, to prevent when the mounting equipment 10 and housing 100 is short-circuited.Compare with known prior art, this has formed particularly advantageous electrode structure.
Structure/the formation of coil
Fig. 7 A and Fig. 7 B have demonstrated out according to the method that is used to construct the Low ESR coil of an embodiment.This is specially adapted to power transmission coil 50.As above hereinafter described, self not charged pool passive implant or have under the situation of implant of rechargable power supplies, having very efficiently, power delivery then is very important.Through by such as the metal individual pen of pure gold Low ESR, bio-compatible or enclose aerial coil more and can realize optimum performance.Regrettably, though gold utensil has good electrical characteristics, mechanical strength is but very low.Owing to motion or impact under the mechanical stress produces, even configuration flexibility, multiply also is very crackly.The measure that embodiment of the present invention proposes is included in the inner chamber of mechanical elasticity plastic tube 51 and places the multiply winding wiring.The preferred selection that is used to manage 51 material is " PEEK (polyether-ether-ketone) " with excellent mechanical properties, and the excellent mechanical properties of said polyether-ether-ketone protects the wiring that it held to avoid impacting or tensile stress effectively.Yet, also can use other material.
The assembly of wiring shown in Fig. 7 A 52 and pipe 51 is formed the shape of expecting, the for example shape shown in Fig. 7 B.Preferably, this is to cool off then and realize through assembly being heated to about 300 ℃ in the intracavity portion that keeps instrument.This process is the shape of molded again whole winding assembly 50 for good and all substantially.
Data coil 60 selectively is made up of similar equipment, perhaps forms by have more elastic metal like rustless steel and so on.Have more in use under the situation of elastic material, then can use polymer cavity.
Conclusion
Will be understood that embodiment described above has very big advantage in the nerve stimulation field.Though passed through with reference to concrete example description the present invention, one skilled in the art will appreciate that the present invention can realize through many other forms.Though the content that is considered to preferred implementation of the present invention has been described; But one of ordinary skill in the art will recognize that; That under the situation that does not depart from spirit of the present invention, can carry out other and further revise to it, the invention is intended to require to protect all this change and modifications that fall into the scope of the invention.For example any method given above all just can employable program representative.Can from block diagram, increase or delete function, also can between functional device, exchange operation.Can from method described herein, increase or delete step, and still among scope of the present invention.

Claims (20)

1. implantable devices comprises:
By the first that flexible, non-conducting material form, said first holds one or more conductive coils;
Be couple to the second portion in the said first, said second portion comprises rigid container, is defined for the chamber that keeps treatment circuit in the said rigid container; And
Be couple to the electrode assemblie on the said second portion, said electrode assemblie comprises the longitudinal bodies of extension away from said first and said second portion, and wherein, said electrode assemblie is couple on the said treatment circuit.
2. equipment according to claim 1, wherein, said second portion comprises base portion and the top that is separated by sidewall, and a plurality of feedthrough components form through said sidewall to be used to allowing wiring between said first and said second portion, to pass.
3. equipment according to claim 2, wherein, said first contacts with the exterior section of said feedthrough component.
4. equipment according to claim 2 comprises inflexible cage, and said cage is fixedly secured on the said second portion, and said cage comprises said first is mechanically secured to the configuration on the said second portion.
5. equipment according to claim 4, wherein, said cage is welded on the said second portion.
6. equipment according to claim 4, wherein, said cage and said second portion form.
7. equipment according to claim 4, wherein, said cage comprises one group of cage member, said one group of cage member is positioned to be defined for said first is fixed to the window on the said cage.
8. equipment according to claim 7; Wherein, said first forms through molding process, thus; But the moulding material that limits said first substantially flows through said window and gets into said cage, thereby with respect to the fixing said first of said second portion.
9. equipment according to claim 2, wherein, said electrode assemblie is couple on the said treatment circuit through said feedthrough component.
10. equipment according to claim 1, wherein, said rigid container is configured for protecting junction point between said electrode assemblie and the said second portion, that be positioned at said equipment downside to avoid downward impact.
11. equipment according to claim 1; Wherein, Said electrode assemblie in the position of the lower surface of said second portion or the position of the lower surface of contiguous said second portion be installed on the said second portion, said position is upcountry spaced apart from the periphery of said second portion.
12. equipment according to claim 11, wherein, said position is in the center basically with respect to the said lower surface of said second portion.
13. equipment according to claim 1, wherein, said rigid container is metal, and said electrode assemblie is an electric insulation with respect to said rigid container.
14. equipment according to claim 1 comprises the power delivery loop, said power delivery loop comprises:
The multi cord coil; With
Around the chamber of said coil, wherein, said chamber is formed by the elastoplast pipe.
15. equipment according to claim 1 comprises ground electrode, said ground electrode comprises the circular metal dish, and wherein, the top surface and the connecting band of said dish expose, and the edge of said dish and lower surface are insulating.
16. equipment according to claim 15, wherein, said rigid container is metal, and said ground electrode is installed in the recess in the outer surface that is formed at said rigid container.
17. a method that is used to form implantable devices, said method comprises:
Rigid container is provided; Be defined for the chamber that keeps treatment circuit in the said rigid container, wherein, said rigid container comprises the feedthrough assembly; Said feedthrough assembly is used to allow wiring between the parts of said treatment circuit and said external container, to pass, and said feedthrough assembly is protected by cage;
Said processing unit is connected on the parts of said external container through said feedthrough assembly, the parts of said external container comprise electrode assemblie and coil;
Utilize molding process to be defined for to hold the flexible alar part of said coil, wherein, said flexible alar part extends in the said cage, thereby said alar part is mechanically connected on the said container.
18. an implantable devices, said implantable devices comprises:
Rigid container; Be defined for the chamber that keeps treatment circuit in the said rigid container, wherein, said rigid container comprises the feedthrough assembly; Said feedthrough assembly is used to allow wiring between the parts of said treatment circuit and said external container, to pass, and said feedthrough assembly is protected by cage;
Be positioned at the parts of said external container, the parts of said external container are couple on the said processing unit through said feedthrough assembly, and wherein, the parts of said external container comprise electrode assemblie and coil;
Be used to hold the flexible alar part of said coil, wherein, said flexible alar part is formed that extend in the said cage through molding process, thereby said alar part is mechanically connected on the said container.
19. a power delivery loop that is used for implantable devices, said power delivery loop comprises:
The multi cord coil; With
Around the chamber of said coil, wherein, said chamber is processed by the elastoplast pipe.
20. a method that is formed for the power delivery loop of implantable devices, said method comprises:
The multi cord coil is provided; With
Said coil is encapsulated in the elastoplast intracavity, thereby limits the coil of encapsulation;
With the coil heats of said encapsulation to more than the predetermined temperature;
With the coil molding of said encapsulation is intended shape; And
Allow the coil cooling of said encapsulation, make the coil of said encapsulation be set at intended shape.
CN2010800055911A 2009-01-27 2010-01-14 Electrical neurostimulator package Pending CN102481449A (en)

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AU2009900289 2009-01-27
PCT/AU2010/000029 WO2010085838A1 (en) 2009-01-27 2010-01-14 Electrical neurostimulator package

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