This invention relates generally to EMI filter terminal subassemblies and related methods of construction, particularly of the type used in active implantable medical devices (AIMDs) such as cardiac pacemakers, implantable defibrillators, cochlear implants, neurostimulators, active drug pumps and the like, which are designed to decouple and shield undesirable electromagnetic interference (EMI) signals from an associated device. More particularly, the present invention relates to an improved EMI filter capacitor that includes various types of counter-drills, counter-sinks or counter-bores for convenient attachment of the feedthrough capacitor to the associated lead wires. The counter-drills, counter-sinks and counter-bores form a convenient well for placement of a thermal setting conductive adhesive, solder, braze material or the like.
Feedthrough terminal assemblies are generally well known for connecting electrical signals through the housing or case of an electronic instrument. For example, in implantable medical devices, the terminal pin assembly comprises one or more conductive terminal pins supported by an insulator structure for a feedthrough passage from the exterior (body fluid side) to the interior of the medical device. Many different insulator structures and related mounting methods are known for use in medical devices wherein the insulator structure provides a hermetic seal to prevent entry of body fluids into the housing of the medical device. In a cardiac pacemaker, for example, the feedthrough terminal pins are typically connected to one or more lead wires within the case to conduct pacing pulses to cardiac tissue and/or detect or sense cardiac rhythms. However, the lead wires can also undesirably act as an antenna and thus tend to collect stray electro-magnetic interference (EMI) signals for transmission into the interior of the medical device. Studies conducted by the United States Food and Drug Administration (FDA), Mount Sinai Medical Center and other researchers have demonstrated that stray EMI, such as RF signals produced by cellular telephones, can seriously disrupt the proper operation of the pacemaker. It has been well documented that pacemaker inhibition, asynchronous pacing and misbeats can all occur. All of these situations can be dangerous or even life threatening for a pacemaker-dependent patient.
In prior art devices, such as those as shown in U.S. Pat. Nos. 5,333,095 and 4,424,551 (the contents of which are incorporated herein), the hermetic terminal pin subassembly has been combined in various ways with a ceramic feedthrough capacitor filter to decouple EMI signals to the equipotential housing of the medical device. As described in U.S. Pat. No. 6,999,818 (the contents of which are incorporated herein), the feedthrough capacitor can also be combined with inductor elements thereby forming what is known in the art as a multi-element low pass filter.
In general, the ceramic feedthrough capacitor, which has one or more passages or feedthrough holes, is connected to the hermetic terminal of the implantable medical device in a variety of ways. In order for the EMI filtered feedthrough capacitor to properly operate, a low impedance and low resistance electrical connection must be made between the capacitor ground electrode plate stack, and the metallic ferrule of the hermetic seal, which in turn mechanically and electrically connects to the overall conductive housing of the implantable medical device. For example, in a cardiac pacemaker, the hermetic terminal assembly consists of a conductive ferrule generally made of titanium which is laser welded to the overall titanium housing of the implantable medical device. This not only provides a hermetic seal, but also makes the ferrule of the hermetic terminal a continuous part of the overall electromagnetic shield that protects the electronics of the implantable medical device from EMI. The ceramic feedthrough capacitor is in turn, electrically and mechanically bonded to the ferrule of said hermetic terminal. Prior art feedthrough capacitors have two plate sets. There is no real polarity associated with a monolithic ceramic capacitor dielectric. However, for the purposes herein, one of the plate stacks is known as the active plate stack, which will be connected to the feedthrough lead wires and the second electrode plate stack will be known as the ground electrode plate stack, which really isn't connected to a ground, but is connected to the overall electromagnetic shield of the active implantable medical device. In other words, this is a method of shield grounding rather than earth grounding.
In the past, and in particular as described in U.S. Pat. Nos. 5,333,095 and 4,424,551, the connection between the feedthrough capacitor and the ferrule is typically performed using a thermal-setting conductive adhesive. One such material is a silver flake loaded conductive polyimide. The connection between the lead wires of the hermetic terminal and the passages or feedthrough holes of the ceramic feedthrough capacitor are typically made with solder, a thermal-setting conductive adhesive, a braze material or the like. The perimeter or diameter of the feedthrough capacitor is typically where its ground electrodes are connected (reference U.S. Pat. No. 5,333,095). Methods of holding the thermal-setting conductive material in place are well described by the prior art, in particular by U.S. Pat. No. 6,643,903 (the contents of which are incorporated herein) which describes a capture flange for convenient dispensing of materials. It is also described by U.S. Pat. No. 6,275,269 (the contents of which are also incorporated herein). Various methods of providing for leak detection are also provided as described in U.S. Pat. No. 6,566,978 (the contents of which are incorporated herein). However, the methodology to make a proper electrical connection between the lead wires and the feedthrough capacitor holes remains problematic.
Prior art feedthrough capacitors generally have a metallization or termination surface around their outside diameter or outside perimeter. This places all of the ground electrode plates in parallel and also provides for a convenient place for attachment of solder or thermal-setting conductive adhesives or the like. In a similar fashion, the inside diameter or feedthrough holes also have an inside diameter metallization surface which puts the active electrode plate set together in parallel. Various methods are known in prior art to make an electrical contact between the feedthrough lead wire and this inside diameter metallization which in turn contacts all of the electrode plates of the active electrode plate set. Application of the prior art metallization (also known as termination) on the capacitor outside diameter and also into all of the capacitor feedthrough holes is a time consuming and costly process. For a typical quadpolar ceramic feedthrough capacitor, application of the termination usually involves placing the capacitor on a mandrel and then rolling its outside diameter through a bed of a liquid silver-bearing glass frit. This glass frit is fired in place thereby conductively coupling all of the ground electrode plates in parallel. Then a vacuum pull process is used to pull metallization or termination material consisting of the same silver or palladium silver glass frit through the ID holes. This is followed by another high temperature glass firing operation. These operations are then followed by lapping or clean up operations to be sure that for small diameter feedthrough capacitors that there is no metallization left on the top or bottom surfaces that could lead to shorting out of the device. Electroplating is an alternative process to accomplish the above. While these processes tend to be very reliable, they are very expensive and time consuming.
One such methodology is described in U.S. Pat. No. 4,424,551. However, the process of injecting a material through repeated centrifuge steps and then repeated microblast cleaning steps is very time consuming, costly and tends to result in low process yields. A superior method of mounting the ceramic feedthrough capacitor is described in U.S. Pat. No. 5,333,095 wherein the capacitor is surface mounted. This has great advantages in that the ceramic capacitor itself is not subjected to undue mechanical or thermal stresses during laser weld installation of the hermetic seal subassembly and to the overall housing of the AIMD. It is relatively easy to make the perimeter or outside diameter ground attachment to the ferrule. However, for a capacitor with a flat surface with lead wires extending through its through-holes, it is problematic to make a reliable electrical connection. This is because solders, thermal-setting conductive polymers, brazes and the like tend to sit up on top of the capacitor. During re-flow operations, at high temperature these materials tend to migrate into undesirable positions. Sometimes the materials will migrate together and even short out one lead to another.
Accordingly, there is a need for improved structure methods and for making connections between a feedthrough capacitor and its associated lead wires which overcome the aforementioned difficulties. The present invention solves all the aforementioned problems and facilitates manufacturing.
EMI filtered terminal assemblies constructed in accordance with the present invention comprise, generally, at least one conductive terminal pin, a filter capacitor, which in the case of a feedthrough filtered capacitor has a passageway through which one or more terminal pins extend, and one or more wells comprising counter-drills, counter-sinks or counter-bores, which are associated with said passageway and lead wire.
As used herein, the terms “counter-drills,” “counter-sinks,” and “counter-bores” are used interchangeably, all of which are known as “wells.”
More particularly, the present invention involves a process for manufacturing an electromagnetic interference (EMI) filter for use in an active implantable medical device (AIMD).
The novel manufacturing process of the present invention comprises the steps of (1) providing a capacitor comprised of a dielectric material having active and ground electrode plates therein and at least one through hole; (2) forming a well in a surface of the capacitor at one end of the through hole; (3) inserting a pin or a lead wire at least partially into the through hole; (4) placing an electrically conductive material in the well, wherein the electrically conductive material comprises a liquid or semi-liquid material during at least some portion of the manufacturing process; and (5) utilizing the electrically conductive material to conductively couple the pin or the lead wire to one of the active or ground electrode plates. In most preferred embodiments shown herein, the novel manufacturing process further includes the step of utilizing an electrically conductive material to attach the pin or the lead wire to the capacitor.
A feedthrough capacitor is mounted to a hermetic seal and subassembly in accordance with one or more prior art methods as described in, for example, U.S. Pat. Nos. 4,424,551 and 5,333,095. The feedthrough capacitor has first and second sets of electrode plates also known as the ground electrode plate set and the active electrode plate set. As previously described, a metallization or termination surface is placed around the outside diameter (or perimeter) of the feedthrough capacitor and also around the inside diameter of each of the feedthrough holes. These termination surfaces connect the ground electrode plates and the active electrode plates in parallel respectively. The terminal pin(s) extend through the passageway(s) of the capacitor in conductive relation with the active set of electrode plates. In a typical implantable electronic device application like a cardiac pacemaker, there is a hermetic insulator supported by a conductive substrate (usually a titanium ferrule) through which the terminal pin passes in non-conductive relation. The capacitor may be bonded onto or into this insulator or separated from the insulator thereby forming a small air gap depending on the assembly method used. The outside diameter or perimeter of the capacitor is generally installed in conductive relation with the conductive substrate or ferrule so that the feedthrough capacitor is properly grounded. Alternative arrangements are shown in U.S. Pat. Nos. 5,905,627 and 7,199,995.
In a preferred embodiment, a feedthrough capacitor having counter-drilled holes on its top side is first bonded to the hermetic insulator. Then attachment is made to the lead wires through a variety of methods including soldering, placement of a thermal-setting conductive adhesive, braze material or the like. Counter-drills can have a variety of shapes. Thermal-setting conductive epoxies, thermal-setting conductive polyimides, solder paste, solder pre-forms, braze pre-forms and the like, are all used to make electrical connection between one or more lead wires and the associated feedthrough holes in the capacitor. Depending upon the application, these counter-drilled areas may or may not be terminated in a similar manner as the capacitor inside diameter hole or the capacitor outside diameter or perimeter.
The novel counter-drill structure of the present invention offers a number of advantages for placement of these electric-conducting materials. The counter-drill recess allows for sufficient volume of said conductive materials to be dispensed in one pass. This can be done with a hand syringe or more desirably, by a robotic dispenser. Because the counter-drill area provides for a greater volume, this will allow for robotic dispensing, for example, of thermal-setting conductive adhesives. Because of the relatively large mass of said material that is placed, typically only one centrifuging operation would be required to drive the electrical conductive material down into the inside diameter of the feedthrough capacitor passageway or hole. Another advantage of the present invention is that the counter-drill recess allows for convenient loading of a solder or braze pre-form. During high temperature re-flow operations, the counter-drill recess holds the material in place so that it cannot flow or creep to areas that are undesirable or would lead to short circuits or other reliability issues.
In the case where the lead wire that passes through the feedthrough capacitor hole is sufficiently small, and the well is sufficiently large, then it would not be necessary to have the inside wells of the counter-drill or well metallized. That is, after centrifuging, the thermal-setting conductive material would be driven down into the annular space between the lead wire and the inside diameter of the feedthrough capacitor in such a way that said thermal-setting conductive adhesive makes an electrical connection between the metallized area and the lead wire thereby connecting the lead wire to the active electrode plate set. However, in the case where the lead wire is a relatively tight fit to the inside diameter of the feedthrough capacitor, it would be desirable to also metalize the inside diameter or inside walls of the counterbore or well so that one is assured of a continuous electrical connection between the metallization that connects all of the active electrode plates in parallel to the inside diameter or inside perimeter of the well such that the thermal-setting conductive material or solder connects all of the active electrode plate sets to the lead wire.
In another embodiment the inside diameter metallization of the feedthrough hole can be eliminated as well as the metallization on the inside diameter of the well. In this case, a sufficient space is left between the lead wire and the capacitor feedthrough hole such that a thermal-setting conductive material can be centrifuged into place. As previously mentioned, the well would contain a sufficient volume of the thermal-setting conductive material that after centrifuging, it will be driven into by centrifugal force and substantially fill in the angular space between the lead wire in the inside diameter of the feedthrough capacitor. However, in this case, the feedthrough capacitor itself has no inside diameter metallization. This is very novel in that prior art feedthrough capacitors typically have a fired or plated on metallization to be assured that proper contact is made to all of the electrode plates. One way to ensure proper contact to all the electrode plates is the centrifuging operation and driving down of sufficient material so that it makes intimate contact with the exposed end of the electrodes within the capacitor through hole. A way to further improve this process is to carefully control the shrinkage between the bulk ceramic capacitor dielectric and the electrode plates themselves. After the holes are drilled and the capacitor is sintered at high temperature, considerable shrinkage occurs. By controlling a differential shrinkage between the electrode plates and the bulk ceramic, one can cause the electrode plates to stick out into the feedthrough hole. Therefore, when the thermal-setting conductive material is centrifuged into place, it will contact and grab onto a larger surface area of the exposed electrode thereby assuring a high reliable and low impedance electrical connection.
The present invention also allows for optional slotted washers to be placed between the hermetic seal feedthrough assembly and the feedthrough capacitor. This is to allow for an air flow channel between each terminal pin to the outside diameter or perimeter. This is important, for example, during soldering operations. During a high temperature re-flow operation, any air that is trapped between the lead wire and feedthrough capacitor inside diameter tends to be expanding as heat is applied. If a solder pre-form, thermal-setting conductive material or the like is sitting on the top, it tends to be blown upward by this expanding air. This is counter balanced by the forces of gravity and capillary action as the solder tries to flow down near the plates. The result, however, usually involves voids and bubbles which are undesirable in the solder surface. The presence of air channels allows the air to escape out through the bottom as the solder nicely drops into place between the lead wire outside diameter and the feedthrough capacitor through-hole inside diameter.
This is generally not necessary when the material is to be centrifuged. When using a centrifuged or pressure injected thermal-setting conductive polyimide, it is desirable to use solid washers so that the high acceleration forces from centrifuging do not drive the material out through the bottom of the capacitor all the way to its outside diameter (or from pin to pin) where short circuits could result.
Another way to think of the novel counter-drills is that they form wells for proper material placement. As mentioned, the counter-drilled wells have a number of important purposes. One is the short term storage of sufficient material to perform reliable electrical connections in a single operation. Another important reason for having a well around each lead wire is that the placement of the electrical conducting material is very highly controlled. This increases the reliability of the completed assembly by eliminating the possibility of conductive slivers, conductive creepage or the like. When conductive particles creep into the wrong area (for example, from lead to lead or from a lead wire to ground) this can result in reduced insulation resistance, reduced battery life of the active implantable device or in the worse case, catastrophic short circuiting.
It is also possible to form any of the counter-bore, counter-drill, counter-sink or semicircular wells of the present invention by pressing these shapes into the ceramic capacitor in its green state. Green state means when the capacitor has not yet been fired so it is still relatively plastic. Then the capacitor can be subsequently fired (sintered) in order to permanently form the shapes as described.
Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.
The accompanying drawings illustrate the invention. In such drawings:
In the description that follows, functionally equivalent components have the same reference numbers.
The primary novel feature is that a well 138 has been formed around each one of the lead wires 120. This well 138 forms a very convenient structure for containment of a solder pre-form, solder paste, braze material, thermal-setting conductive adhesive or the like.
It is a problem in prior art assemblies, such as those described in
Referring once again to
Elimination of the capacitor inside diameter termination reduces a number of process steps and greatly reduces the cost of the overall assembly. In an alternative embodiment (not shown), outside diameter metallization could also be eliminated and the ground electrode plates could also protrude around the outside diameter of the capacitor. In this case, the outside diameter of the capacitor would also be put into a well and/or the thermal-setting conductive material would have to be placed up along the side such that the ground electrode plates 106 all ended up electrically in parallel.
On the right hand side of
The formation of the feedthrough holes and the novel wells of the present invention are easily performed by robotic operations. That is, it has become very common in the manufacturing of feedthrough capacitors to drill their center holes using automated printed circuit board drilling machines. Bars of green ceramic material are typically placed inside the robotic drilling machine. These bars already contain the inner and outer electrode patterns and have been laminated. Tens or even hundreds of capacitors are in one single bar. Automatic pattern recognition programs are used. The automated drilling machine automatically picks up the right bit size, automatically locates the center of each hole and drills it very quickly. This is done much more accurately than can be done by the human eye. These same printed circuit board automated drilling machines also have the capability of automatically picking up other bits. Therefore, for very little additional labor expense, the machine can be programmed to pick up the various tool shapes to form the various wells (counter-sinks, counterbores, etc.) of the present invention.
Accordingly, it is a feature of the present invention that any of the novel well shapes as previously described could be literally cut or pressed into the capacitor prior to its final sintering operation.
From the foregoing it will be appreciated that the novel manufacturing process of the present invention comprises the steps of: (1) providing a capacitor comprised of a dielectric material having active and ground electrode plates therein and at least one through hole; (2) forming a well in a surface of the capacitor at one end of the through hole; (3) inserting a pin or a lead wire at least partially into the through hole; (4) placing an electrically conductive material in the well, wherein the electrically conductive material comprises a liquid or semi-liquid material during at least some portion of the manufacturing process; and (5) utilizing the electrically conductive material to conductively couple the pin or the lead wire to one of the active or ground electrode plates. In most preferred embodiments shown herein, the novel manufacturing process further includes the step of utilizing an electrically conductive material to attach the pin or the lead wire to the capacitor.
Although several embodiments of the invention have been described in detail for purposes of illustration, various modifications of each may be made without departing from the spirit and scope of the invention. Accordingly, the invention is not to be limited, except as by the appended claims.
Number | Date | Country | |
---|---|---|---|
61055305 | May 2008 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 12437345 | May 2009 | US |
Child | 13926255 | US |