CN102824692B - Feed-through connector for implantable medical device and manufacturing method - Google Patents
Feed-through connector for implantable medical device and manufacturing method Download PDFInfo
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- CN102824692B CN102824692B CN201210336920.1A CN201210336920A CN102824692B CN 102824692 B CN102824692 B CN 102824692B CN 201210336920 A CN201210336920 A CN 201210336920A CN 102824692 B CN102824692 B CN 102824692B
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Abstract
The invention discloses a feed-through connector for an implantable medical device. The feed-through connector comprises a flange ring, an insulator, at least one signal probe, and a glass sealing body for fixing and tightly sealing the structure. The feed-through connector also comprises a grounding probe, and a plurality of probe sleeves; the flange ring is provided with an upper brim, a lower brim and an inner hole; the glass sealing body contains the components in mass percent: about 60-80% of SiO2, about 5-15% of Al2O3, about 10-25% of B2O3, about 0-5% of Li2O, about 5-15% of Na2O and about 0-5% of K2O. The insulator is sealed in the inner hole of the flange through the glass sealing body; the signal probe is sealed in a through hole of the insulator; the grounding probe is fixed at the lower brim of the flange to provide a metal housing and a simulation circuit to be grounded commonly, and the probe sleeves are fixed at the end part of the probe to improve the connection performance.
Description
Technical field
The present invention relates to a kind of feed through connector for implantable medical device, belong to implantable medical device manufacturing technology field.
Background technology
This section provides background information related to the present invention and technology.
Implantable medical device medically obtains applying more and more widely in recent years.The implantable medical device of electricity irritation function (being also implanted electric stimulator) is had to be the implanting device that a class has Complex Electronic Systems Based, in order to measure human body physiological parameter secular change and to treat some disease.Known implanted electric stimulator system generally includes the pulse generator, extension lead and the electrode that implant, and is positioned at external control device etc.The signal that pulse generator sends, by feed through connector, is connected with outside contiguous block and extension lead, then is transferred to target tissue by electrode catheter, plays electronic stimulation effect.Feed through connector is the vitals connecting pulse generator internal circuit and extension lead, is the passage of Signal transmissions, the functions such as the transmission of realization sealing, insulation, signal and filtering.Current feed through connector has been applied to implantable medical device as cardiac pacemaker, brain depth stimulator and spinal stimulator etc.
Implantable medical device generally implants several years even decades in human body complex environment, once the access arrangement such as body fluid, steam is inner, will cause failure of apparatus.General implantable medical device all requires higher air-tightness, and feed through connector is as the important composition of sealing part, and its sealing property quality directly determines the life-span of implanting device; In addition, based on implantation requirement, the manufacture of feed through connector should meet biocompatibility requirement; As the passage of stimulus signal transmission, insulation and the support function that necessity should be provided of feed through connector; As the circuit connecting mechanism connecting internal circuit board and Outer elongate wire, feed through connector should have good method of attachment with above-mentioned two assemblies.
Typical feed through connector is made up of probe, flange lasso, insulator and sealing-in body.The material category related to includes but not limited to the high molecular polymer, glass, pottery, metal etc. of biocompatibility, and the Sealing Technology related to includes but not limited to the sealing of polymeric seal, glass/metal, ceramic/metal sealing, glass/ceramic sealing, metal/metal sealing etc.As the critical component of implantable medical device, the product of the feed through connector of the current clinical practice mainly offshore company such as U.S. Medtronic.The PCT patent of invention (application publication number CN 102470249 A) that american wheat De Tuonike company enters China devises a kind of glass and makes feed through connector assembly.But this patent only relates to the application of the glass insulator component of certain special component, and the difficult point be not connected with other assemblies feed through connector and solution are studied, and use and have certain limitation.
Summary of the invention
The object of the invention is for implantable medical device provides a kind of feed through connector of permanently effective, dependable performance and relevant manufacture method thereof.Object of the present invention is achieved through the following technical solutions.
For a feed through connector assembly for implantable medical device, comprise flange lasso, probe, insulator and sealing-in body, it is characterized in that, described insulator and sealing-in body formed by glass preform, and the composition of described glass preform comprises:
60-80%(weight) SiO
2,
5-15%(weight) Al
2o
3,
10-25%(weight) B
2o
3,
0-5%(weight) Li
2o,
5-15%(weight) Na
2o, and
0-5%(weight) K
2o.
Preferably, described flange lasso can connect described implantable medical apparatus casing and described insulator, and described flange lasso has endoporus, and described internal via shape includes but not limited to circle, rectangle or triangle; Described flange lasso profile includes but not limited to circle, rectangle or triangle.
Preferably, have outside described flange sleeve collar aperture two or more, the circular foil member that is arranged above and below, and the diameter of bottom sheet is greater than slice.
Preferably, described probe comprises
One or more first signal probe, its arrangement mode is annular, linear or rectangular, and described first signal probe is established through hole respectively and passed in described insulator, in order to connect internal interface end and the outside terminal of described implantable medical device;
A secondary signal probe, for connecting described implantable medical device internal circuit ground wire and described flange lasso.
Preferably, described probe is provided with for forming with other parts the connecting elements be electrically connected.
Preferably, described connecting elements is the annulus being positioned at described probe tips.
Preferably, described connecting elements is the metal coating on probe portion surface.
Present invention also offers a kind of manufacture method of the feed through connector assembly according to above-mentioned arbitrary technical scheme, comprising:
There is provided jig, described jig is provided with the locating hole of flange lasso and probe, the bottom of described flange lasso contacts with the surface of described jig;
Glass preform is inserted in the endoporus of described flange lasso;
Insert probe in described probe positioning hole;
Jig entirety is put into heating furnace to carry out heating and obtain feed through connector.
Preferably, the outer wall of described flange lasso inwall and described probe carries out pretreatment by the method for chemical attack or heating in advance.
Preferably, also comprise and probe tips is connected upper annulus, or do metal coating on probe portion surface.
Preferably, also comprise the secondary signal probe in described probe is fixedly electrically connected with described flange lasso.
Feed through connector of the present invention, bio-compatible, good airproof performance, dependable performance; The manufacture method of feed through connector of the present invention, simple and easy to do, production efficiency is high, economic and practical.
Accompanying drawing explanation
Fig. 1 is the assembling schematic diagram of general implantable medical device shell and feed through connector;
Fig. 2 is the structural representation of feed through connector;
Fig. 3 is the decomposing schematic representation of feed through connector;
Fig. 4 is according in the multiple embodiment of the present invention, with the feed through connector decomposing schematic representation of grounded probe and sleeve pipe;
Fig. 5 is according to multiple embodiment of the present invention, the feed through connector schematic diagram of different structure.
Detailed description of the invention
This section will by reference to the accompanying drawings, illustrates embodiments of the present invention.
The object of the invention is for implantable medical device provides sealing property excellent and feed through connector reliably and with long-term.Feed through connector is the vitals of implantable medical equipment, bears the critical functions such as sealing, signal transmission, insulation, can require higher to biocompatibility, air-tightness, connectivity.
Fig. 1 is the assembling schematic diagram of general implantable medical device shell and feed through connector, and typical structure is applicable to implantable medical device as cardiac pacemaker, brain depth stimulator and cardiac defibrillator etc.Wherein 20 is the shell of implanting device, is generally biocompatibility metal (as titanium or its alloy) made.10 is feed through connector, and in schematic diagram, feed through connector is circular four point probe type feed through connector, can change the quantity of probe and the shape of feed through connector as required in practical application.As shown in Figure 1, shell 20 protects inner circuit, and its signal is outwards transmitted by the probe of feed through connector 10, and shell 20 provides necessary support and connection for feed through connector 10.
Fig. 2 gives the structural representation of feed through connector.Example feed through connector 100 forms primarily of three parts, flange lasso 101, insulator 102 and probe 103, and its assembling form is that flange lasso 101 is enclosed within outside insulator 102, and probe 103 inserts in insulator 102 endoporus.
Fig. 3 gives the decomposing schematic representation of feed through connector.As shown in the figure, flange lasso 101 is generally made up of titanium or titanium alloy, includes for placing insulator 102(herein for cylinder) endoporus, and on flange under 201 and flange along 202.On along 201 be along 202 the foil extended outside circular sleeve down, be greater than along 201 along the external diameter of 202 wherein.Flange lasso 101 mainly plays fixing and supporting role, along 201 and form a groove between 202 down on flange, the metal shell of implanting device is assembled by described groove and feed through connector 100, flange is overlapped on metal shell surface along the bottom of 201, realizes being tightly connected by melting (as argon arc welding, Laser Welding etc.) and shell, reach the fixing of feed through connector 10 and metal shell 20 with this, be tightly connected.Under described flange along the diameter of 202 slightly larger than on along 201, be due on melting (as argon arc welding, Laser Welding etc.) flange along 201 with metal shell 20 process in, effectively can keep out the electric arc or laser that leak through in welded gaps, play heat-blocking action, avoid welding process to damage internal components.
The probe 103 of described feed through connector, lower end is connected to the signal circuit outfan of metal shell 20 inside, and upper end is connected to Outer elongate wire.Probe 103 is unique passages that signal externally conducts from internal circuit, and it mostly is filament, and material can select biocompatibility metal as titanium, niobium, tantalum, platinum, iridium, molybdenum, tungsten, titanium-niobium alloy, platinumiridio or other applicable materials etc.
Insulator 102 can be made up of glass preform.According to such as Fig. 3 exemplary construction, glass preform is column, and center has through hole, and height is basically identical or slightly difference with flange lasso 101, excessive in can effectively avoiding excess glass to melt like this, and glass deficiency cannot fill full flange lasso 101 endoporus.Glass preform is embedded in the endoporus of flange lasso 101, and probe 103 can be inserted in preform endoporus.The one composition of glass preform comprises SiO
2(about 60-80%), Al
2o
3(about 5-15%), B
2o
3(about 10-25%), Li
2o(is about 0-5%), Na
2o(is about 5-15%) and K
2o(is about 0-5%) etc., wherein content is mass percent.In other implementations, available CaO, MgO replace Na
2o, K
2o.The external diameter of preform is slightly less than the endoporus of flange lasso 101, the endoporus of preform slightly larger than the external diameter of probe 103, to adapt to assembling.
In multiple embodiment of the present invention, insulator 102 also can be made up of bio-compatible ceramics, as aluminium oxide, zirconium oxide or silicon nitride etc.Wherein insulator 102 adopts glass solder or brazing metal etc. to carry out soldering with probe 103 and flange lasso 101, forms soldering sealing-in body and realizes the hermetic seal of pottery and metal flange and probe.
The sealing property quality of feed through connector depends on that insulator and metal form the airtight quality of sealing-in body, i.e. the sealing surface 205 of insulator 102 with flange lasso 101 and the sealing surface 204 of insulator 102 and probe 103.Glass preform is heated, and through the process such as softening, fusing, cooling, forms sealing surface respectively with flange lasso 101 and probe 103.The prerequisite that generation is tightly connected is that the glass of molten state can with the metal surface moistening treating sealing-in.And the glass of molten state and simple metal are difficult to moistening, here pretreated way is adopted, make the inwall of flange lasso 101 and the outer wall initial oxidation of probe 103 or nitrogenize, surface forms layer of oxide layer or nitration case, greatly can improve the wettability with glass like this, complete sprawling and sealing-in in 204,205 two faces.Further, thermal coefficient of expansion (CTE) difference of sealing surface two layers of material is to being sealed with material impact, if CTE difference is comparatively large, then sealing surface very easily cracks and causes seal failure.This example feed through connector, by selecting different match materials, flange lasso 101, between glass insulator 102 and probe 103 CTE difference within 15%, can Leakless sealing be realized.
The invention provides the manufacture method of example feed through connector.Select suitable material (material non-wetted with described glass preform, avoids bonding) to make jig, jig has the locating hole of flange lasso and probe.In advance by the method such as chemical attack or heating, pretreatment is carried out, as described in epimere to flange lasso 101 inwall and probe 103 outer wall.Holding clamp, inserted in the middle of jig in locating hole successively by flange lasso 101, bottom 206 contacts with jig surface.Successively glass preform is inserted again in the endoporus of flange lasso 101, then insert probe 103 successively in glass preform and probe positioning hole, complete the assembling of feed through connector.Jig entirety is put into heating furnace heat, adopt the protective atmosphere of high-purity argon gas, avoid polluting.Control sintering process process, regulate the parameter such as sintering temperature, temperature retention time, form glass sealing body, and obtain shaping, airtight qualified feed through connector.In some embodiments, carry out Curve guide impeller to jig, the protection that can also come feed through connector sintering process by jig, avoids the pollution on flange lasso 101 surface.
Fig. 4 is according in the multiple embodiment of the present invention, with the feed through connector decomposing schematic representation of grounded probe and sleeve pipe.Exemplified feed through connector 300, includes flange lasso 301, insulator 302, signal probe 303 and grounded probe 310.There is sleeve pipe 320 end of grounded probe.
The invention provides the insulator 302 of this embodiment, can be made up of glass preform.The one composition of glass preform comprises SiO
2(about 60-80%), Al
2o
3(about 5-15%), B
2o
3(about 10-25%), Li
2o(is about 0-5%), Na
2o(is about 5-15%) and K
2o(is about 0-5%) etc., wherein content is mass percent.In some other embodiment, available CaO, MgO replace Na
2o, K
2o.This glass ingredient differs with the CTE value of institute's sealing-in both sides metal and can maintain within 15%, avoids the appearance of large crackle, ensures sealing.
In multiple embodiment of the present invention, insulator 302 can be made up of biocompatible pottery, as aluminium oxide, zirconium oxide or silicon nitride etc.Adopt glass solder or brazing metal etc. to carry out soldering, realize the hermetic seal of pottery and metal flange and probe.
Example feed through connector 300 has signal probe 303 and grounded probe 310, the two all can by titanium, niobium, tantalum, platinum, iridium, molybdenum, tungsten, platinumiridio or other accommodate material and make.Signal probe 303 and insulator 302 Leakless sealing, 303 is passages of Signal transmissions, needs can design the spininess type feed through connector corresponding with multiple signals, such as crosspointer, four pin feed through connector etc. according to stimulation.Grounded probe 310, one end is connected to the lower on bottom 305 of flange lasso 301, form joint 311, and the other end is connected to the ground wire of stimulation circuit.Joint 311 is shaped by the method such as resistance spot welding, laser weld.
Flange lasso and metal shell are by being welded to connect, therefore metal shell is connected with the ground wire of stimulation circuit with grounded probe 310 by flange lasso 301, as a ring in stimulus signal loop.Stimulus signal spreads out of from internal circuit through signal probe 303, arrives electrode, and there is potential difference between metal shell through extension lead.Known further thus, in feed through connector 300, probe 303 transmits stimulus signal, and flange lasso 301 transmits ground signalling, and the two must isolate by insulating part 302, avoids the harm such as short circuit.
The invention provides a kind of probe casing 320, is for solving following two problems connected.
The bottom of described signal probe 303 and the far-end of described grounded probe 310 need to be connected with the ground wire of stimulation circuit with the signal output part of stimulation circuit respectively, and namely a side end of two kinds of probes need be connected on internal circuit board.Conventional coupling arrangement welds the same with circuit board element, adopts Sn-coupled SSBR.But owing to adopting biocompatibility metal as probe material, portion of material is as poor in niobium, platinum etc. and the adhesive property of stannum and hard fragility is higher, makes the intensity of soldering joint not high, the defects such as normal appearance fracture.
The top of described signal probe 303 is connected with the stainless steel metal block of Outer elongate wire, traditional method adopts the mode of resistance spot welding, and the bonding strength of resistance spot welding is limited, and easily there is the defects such as rosin joint, laser weld can be used instead connect to improve bond strength.But owing to adopting biocompatibility metal as the material of probe 303,310, portion of material is as poor with stainless steel material laser weld associativity in niobium, platinum etc., often needs to be inputted by high-energy just to make it fully fuse.And excess energy easily causes cause thermal damage, distortion to peripheral circuits device or other materials (as plastics), these all limit laser weld application herein.
According to above two sections probe connect on problem, the invention provides a kind of probe casing 320.Casing inner diameter is slightly larger than probe external diameter, suitable just can be assembled into.Sleeve pipe adopts the material that the welding performances such as titanium, nickel, vanadium or its alloy are excellent.First sleeve pipe 320 is enclosed within probe tips 321 place of probe 303 and 310, adopts resistance spot welding to weld several points with 321 by 320 after adjusting position, keep being fixedly connected with.And then be connected with circuit board Sn-coupled SSBR by the probe tips 321 with sleeve pipe 320, shell material can be more easily bonding with stannum, to realize the normal conduction of the signal of telecommunication; And with the probe tips 321 of sleeve pipe 320 and outside stainless steel metal block laser weld, under less hot initial conditions, the two just can realize good fusing connection, to realize the normal conduction of the signal of telecommunication.
In multiple embodiment of the present invention, coated metal can be adopted to realize above-mentioned functions, change in probe tips 321 surface deposition layer of metal by sleeve pipe 320.Adoptable deposition process comprises the modes such as plating, ion plating, sputtering or thermal spraying, and available coated metal comprises copper, nickel, titanium, vanadium or its alloy material etc.The coated metal selected can improve detecting probe surface activity, contributes to the moistening of tin solder and the stable of laser weldability.But note other positions, feed through connector surface also to be plated metal in galvanization process, otherwise the short circuit between signal probe may be caused.
Described feed through connector 100 and 300 is single needle feed through connector, but the specific requirement that can use according to feed through connector in practical application, design spininess type feed through connector.The arrangement mode of its probe can be annular, linear, rectangular or other forms, and the quantity of probe and arrangement mode can change with flange lasso internal via shape according to requirements, and corresponding insulator shape also changes thereupon.Fig. 5 provides several frequently seen feed through connector arrangement form, and diagram black circle representation signal probe, housing line represents flange internal via shape.Be annular outside 401 to 404 flange lassos and insulator, 401 is annular single needle feed through connector, and 402 is annular crosspointer feed through connector, and 403 is annular four pin feed through connector, and 404 is annular six pin feed through connector; Be rectangle (or having fillet) outside the flange endoporus of 405 to 407 and insulator, 405 is single linear array feed through connector, and 406 is double linear array feed through connector, and 407 is square arrangement feed through connector; Be triangle outside the flange endoporus of 408 and insulator, signal probe is also triangle arrangement.Except exemplified form, conversion flange internal via shape and signal probe arrangement can have similar combination, here do not enumerate.
Illustrative for description of the invention in literary composition, because scope of the present invention should not be limited to above-mentioned detailed description of the invention.It will be apparent to one skilled in the art that when not departing from purport or the substitutive characteristics of this reality invention, can other distortion be carried out to above-mentioned detailed description of the invention or change.
Claims (11)
1. for a feed-through component for implantable medical device, comprise flange lasso, probe, insulator and sealing-in body, it is characterized in that, described insulator and sealing-in body formed by glass preform, and the composition of described glass preform comprises:
The SiO of 60-80% (weight)
2,
The Al of 5-15% (weight)
2o
3,
The B of 10-25% (weight)
2o
3,
The Li of 0-5% (weight)
2o,
The Na of 5-15% (weight)
2o, and
The K of 0-5% (weight)
2o;
The inwall of described flange lasso and the outer wall of described probe are formed with layer of oxide layer or nitration case;
Described insulator is made up of aluminium oxide, zirconium oxide or silicon nitride;
Described insulator and described probe and described flange lasso adopt glass solder or brazing metal to carry out soldering, form soldering sealing-in body and realize the hermetic seal of pottery and metal flange and probe;
Described flange lasso, between glass insulator and probe thermal coefficient of expansion (CTE) difference within 15%, to realize Leakless sealing.
2. feed-through component according to claim 1, it is characterized in that, described flange lasso can connect the housing of described implantable medical device and described insulator, and described flange lasso has endoporus, and described internal via shape includes but not limited to circle, rectangle or triangle; Described flange lasso profile includes but not limited to circle, rectangle or triangle.
3. feed-through component according to claim 1, is characterized in that, have outside described flange sleeve collar aperture two or more, the circular foil member that is arranged above and below, and the diameter of bottom sheet is greater than slice.
4. feed-through component according to claim 1, is characterized in that, described probe comprises:
One or more first signal probe, its arrangement mode is annular, linear or rectangular, and described first signal probe is established through hole respectively and passed in described insulator, in order to connect internal interface end and the outside terminal of described implantable medical device;
A secondary signal probe, for connecting described implantable medical device internal circuit ground wire and described flange lasso.
5. feed-through component according to claim 1, is characterized in that, described probe is provided with for forming with other parts the connecting elements be electrically connected.
6. feed-through component according to claim 5, is characterized in that, described connecting elements is the annulus being positioned at described probe tips.
7. feed-through component according to claim 5, is characterized in that, described connecting elements is the metal coating on probe portion surface.
8. a manufacture method for the feed-through component according to any one of claim 1-7, comprising:
There is provided jig, described jig is provided with the locating hole of flange lasso and probe, the bottom of described flange lasso contacts with the surface of described jig;
Glass preform is inserted in the endoporus of described flange lasso;
Insert probe in described probe positioning hole; The inwall of described flange lasso and the outer wall of described probe are formed with layer of oxide layer or nitration case;
Jig entirety is put into heating furnace to carry out heating and obtain feed through connector;
Described insulator is made up of aluminium oxide, zirconium oxide or silicon nitride;
Described insulator and described probe and described flange lasso adopt glass solder or brazing metal to carry out soldering, form soldering sealing-in body and realize the hermetic seal of pottery and metal flange and probe;
Described flange lasso, between glass insulator and probe thermal coefficient of expansion (CTE) difference within 15%, to realize Leakless sealing.
9. method according to claim 8, is characterized in that, the outer wall of described flange lasso inwall and described probe carries out pretreatment by the method for chemical attack or heating in advance.
10. method according to claim 8, is characterized in that, also comprises and probe tips is connected upper annulus, or do metal coating on probe portion surface.
11. methods according to claim 8, is characterized in that, also comprise and being fixedly electrically connected with described flange lasso by the secondary signal probe in described probe.
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| CN201210336920.1A CN102824692B (en) | 2012-09-12 | 2012-09-12 | Feed-through connector for implantable medical device and manufacturing method |
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| CN201210336920.1A CN102824692B (en) | 2012-09-12 | 2012-09-12 | Feed-through connector for implantable medical device and manufacturing method |
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| US9431801B2 (en) * | 2013-05-24 | 2016-08-30 | Heraeus Deutschland GmbH & Co. KG | Method of coupling a feedthrough assembly for an implantable medical device |
| EP3107623B1 (en) | 2014-02-21 | 2019-03-27 | Cardiac Pacemakers, Inc. | Filtered feedthrough assembly for implantable medical electronic devices |
| US9865533B2 (en) * | 2014-12-24 | 2018-01-09 | Medtronic, Inc. | Feedthrough assemblies |
| US9968794B2 (en) * | 2014-12-24 | 2018-05-15 | Medtronic, Inc. | Implantable medical device system including feedthrough assembly and method of forming same |
| US10136535B2 (en) | 2014-12-24 | 2018-11-20 | Medtronic, Inc. | Hermetically-sealed packages including feedthrough assemblies |
| EP3111993B1 (en) * | 2015-06-30 | 2020-06-24 | Oticon Medical A/S | Feedthrough connectors |
| US10098589B2 (en) | 2015-12-21 | 2018-10-16 | Medtronic, Inc. | Sealed package and method of forming same |
| CN108899710B (en) * | 2018-04-28 | 2020-08-11 | 北京品驰医疗设备有限公司 | Feed-through filter, manufacturing method thereof and implantable electrical stimulator |
| CN113054294B (en) * | 2021-03-02 | 2023-04-07 | 清华大学 | Battery for active implanted medical instrument |
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