Patent Application
20140345934
One aspect relates to a feedthrough device for an implantable medical device. Feedthroughs establish an electrical connection between a hermetically sealed interior and an exterior of the medical device. Known implantable therapeutic devices include cardiac pacemakers or defibrillators, which usually include a hermetically sealed metal housing, which is provided with a connection body, also called header, on one side. Said connection body includes a connection socket for connecting electrode leads. In this context, the connection socket includes electrical contacts that serve to electrically connect electrode leads to the control electronics in the interior of the housing of the implantable therapeutic device—also called implantable device. An essential prerequisite for an electrical bushing of this type is hermetic sealing with respect to the surroundings.
Accordingly, it needs to be made sure that the conducting wires that are introduced into an insulation element and via which the electrical signals proceed, are introduced into the insulation element without any gaps. In this context, it has proven to be disadvantageous that the conducting wires in general are made of a metal and need to be introduced into a ceramic insulation element. In order to ensure long-lasting connection between the two elements, the internal surface of the bore hole in the insulation element must be metallized for soldering the conducting wires into them. Said metallization inside the bore hole in the insulation element has proven to be difficult to apply. Homogeneous metallization of the internal surface of the bore hole in the insulation element can be ensured only by means of expensive procedures. Alternatively or in addition to, brazing may be used to connect the wires to the insulation element. Both metallization and brazing, however, can lead to leaks over time.
For these and other reasons there is a need for the present invention.
The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise.
One embodiment is a method of coupling a feedthrough assembly to a surrounding case of an implantable medical device. The method provides an insulator having a plurality of conducting elements extending therethrough. The insulator with conducting elements is placed within an opening of a case, thereby defining a narrow space between the insulator and the case. A braze preform is placed adjacent the insulator and case in the narrow space. The insulator is heated with a laser until the temperature of the adjacent preform is raised above its melting point such that it flows and fills the space between the insulator and the case.
In one embodiment, the temperature of the preform is raised above its melting point by directing the laser exclusively at the case and the insulator and not at the preform. In this way, by avoiding directing too much energy at the preforms, this creates a high-quality seal between the feedthrough assembly and the case with the melted preform. If the laser were to be directed at the preform, spattering of the material of the preforms will occur, such that the seal between the case and feedthrough assembly can be compromised.
In one embodiment, the braze preform is place on a feature that is formed in the case or in the insulator, or in their combination. In one embodiment, the feature is configured with a surface configured to securely hold the braze preform while it is heated by the laser. In this way, the preform will stay in the correct position between the case and in the insulator so that its melting will fill the narrow space therebetween.
In one embodiment, the braze preform, the insulator, and the case are first heated in an oven or other heating apparatus prior to heating the insulator with the laser. In this way, the heat from the laser does not need to increase the temperature of the preform from room temperature all the way up to its melting point, which would require significant laser energy and could cause defects in some instances. For example, if the laser is used to increase the temperature all the way from room temperature to the melting point of the preform, the insulator at which the laser is directed may experience surface damage and cracking. In one embodiment, the braze preform, the insulator, and the case are heated to at least 600-800° C. prior to heating the insulator with the laser. In that case, the heat from the laser only needs to increase the temperature of the preforms from 600-800° C. to the melting temperature of the preforms.
In one embodiment, the braze preform, the insulator, and the case are heated in a container, which is vacuum-sealed, prior to heating the insulator with the laser. In one embodiment, the container is filled with an inert gas while heating the braze preform, the insulator, and the case in the container. In one embodiment, it is advantageous to leave the braze preform, the insulator, and the case in the container even after it is heater therein, and then heating the insulator with a laser through a glass portion of the container while the insulator is within the container. In one embodiment, the vacuum-sealed and/or inert gas-filled container prevents oxidation of the case during heating.
In one embodiment, the insulator is heated with a laser on a surface opposite where the braze preform is placed, such that the braze preform is pulled toward the laser as it melts from the heat of the applied laser. In some cases this will help pull the molten braze through the narrow space between the insulator and the case ensuring a filled and hermetic seal between them.
In one embodiment, an implantable medical device includes a feedthrough assembly comprising an insulator and a plurality of conducting elements extending therethrough. A case is provided with an opening into which the feedthrough assembly is placed defining a narrow space therebetween. A braze material fills the narrow space, thereby hermetically sealing the feedthrough assembly to the case. The medical device is characterized in that one of the feedthrough assembly and the case comprise a feature configured to securely hold the braze and in that the implantable medical device does not include a ferrule. In one embodiment, the feature is a step in the case or feedthrough assembly defining a surface on which the braze material is securely held. In this way, the preform will stay in the correct position between the case and in the insulator so that its melting will fill the narrow space therebetween.
In one embodiment, the feedthrough assembly comprises a top surface that is exterior to the case and the step has a surface that is parallel to the top surface of the feedthrough assembly. This surface in the step provides an ideal flat surface on which the preform can sit, without sliding or moving, so that it can be melted into place. In one embodiment, the narrow space between the feedthrough assembly and case is no less than 10 μm and no more than 50 μm. This distance range provides a good capillary action for the braze to fill the space and provide a good seal.
In one embodiment, the insulator and plurality of conducting elements are hermetically sealed together without solder or braze. In this way, the hermetic seal between the insulator and plurality of conducting elements is not compromised during the melting of the braze between the feedthrough assembly and case. In one embodiment, this is achieved by using cermet for the plurality of conducting elements.
In one embodiment, the medical device is characterized in that the feedthrough assembly includes metallization on at least one surface in order to control the dimensions of the braze. In one embodiment, it is advantageous for the metallization on the feedthrough assembly to control the braze dimensions such that it is at least 0.010 inches below the top surface of the feedthrough assembly and at least 0.010 inches above a bottom surface of the feedthrough assembly.
Ferrule 12 is configured to fit into an opening of a case for an implantable medical device and such that it can be tightly secured thereto in order to ensure a hermetic seal with respect to an internal space of the medical device. Feedthrough pins 16 extend from within the internal space of the case of the medical device to outside the device, thereby providing electrical connection from the inside to the outside, while maintaining a hermetic seal. Flanges 22 can be provided on ferrule 12 to further aid in securing feedthrough device 10 to the opening of the case of the implantable medical device and ensuring its hermetic seal.
Typically, insulator 14 is a ceramic or glass material, while ferrule 12 is metallic. Ferrule 12 is metallic so that it can be readily welded to a metallic case of the implantable medical device. In order for the ceramic material of insulator 14 to be coupled to the metallic material of ferrule 12, insulator 14 is typically “metalized” with metalized coating 20. Alternatively, a metallic braze is used to secure ceramic material of insulator 14 to the metallic material of ferrule 12. Similarly, braze 18 is used to couple the ceramic material of insulator 14 to feedthrough pins 16, which are metallic conductors.
Use of braze 18 to secure insulator 14 to feedthrough pins 16 and to secure insulator 14 to ferrule 12, and/or the need for metalized coating 20 to secure insulator 14 to ferrule 12 creates extra processing steps and adds to the complication and expense of manufacturing feedthrough device 10. Such braze 18 and metallization 20 can also lead to leaks and failure of a hermitic seal for feedthrough device 10.
In one embodiment, conducting elements 114 of feedthrough assembly 102 are an electrically conductive material such that they provide a conductive path from internal space 120 to external space 122 of case 104. Insulator 112 is of a non-electrically conductive material such that there is no conductive connection among the conducting elements 114 or between the conducting elements 114 and case 104. All of the interfaces between insulator 112 and conducting elements 114 and between insulator 112 and case 104 are sealed in such a way that a hermetic seal is maintained between internal space 120 and external space 122 of case 104. In one embodiment, all of the interfaces between insulator 112 and conducting elements 114 are hermetically sealed without the use of braze or solder, as will be more fully explained below.
Unlike feedthrough device 10 of
In one embodiment, feedthrough assembly 102 is assembled by forming insulator 112 and conducting elements 114 in a first process. In one embodiment, insulator 112 is a ceramic material, such as aluminum oxide (Al2O3), and conducting elements 114 are a cermet material.
In the context of one embodiment, the terms, “cermet” or “cermet-containing,” shall refer to all composite materials made of ceramic materials in a metallic matrix (binding agent). These are characterized by their particularly high hardness and wear resistance. The “cermets” and/or “cermet-containing” substances are cutting materials that are related to hard metals, but contain no tungsten carbide hard metal and are produced by powder metallurgical means. A sintering process for cermets and/or the cermet-containing elements proceeds just like with homogeneous powders with the exception that the metal is compacted more strongly at the same pressuring force as compared to the ceramic material. The cermet-containing bearing element has a higher thermal shock and oxidation resistance than sintered hard metals. In most cases, the ceramic components of the cermet are aluminum oxide (Al2O3) and zirconium dioxide (ZrO2), whereas niobium, molybdenum, titanium, cobalt, zirconium, chromium and platinum are conceivable as metallic components.
The ceramic of insulator 112 can be, for example, a multi-layer ceramic sheet into which a plurality of vias is introduced. The cermet of conducting elements 114 is then introduced into the vias. In one embodiment, both materials are introduced in a green state, and as such, the combination is fired together. Accordingly, the joining of the insulator 112 and conducting elements 114 forms a hermetic seal therebetween without the use of braze or solder.
In one embodiment, preforms 110a are gold braze placed relatively close to outside surface 102b of feedthrough 102. In one embodiment, lasers 140 and 141 heat feedthrough 102 to a temperature high enough so as to induce a temperature in preforms 110a above the melting point of gold. As such, preforms 110a will begin to melt and flow from the high temperature caused by activated lasers 140 and 141.
In one embodiment, two lasers 140 and 141 are used, but in other embodiments a single laser is used. In yet other embodiments, additional lasers are used to heat feedthrough 102. In some embodiments, the lasers are directed toward outside surface 102b to ensure it is heated and will therefore transfer heat effectively to preforms 110a. In other embodiments, lasers 140 and 141 scan the entire top surface of feedthrough 102 to heat the entire feedthrough 102. In yet other embodiments, lasers 140 and 141 scan the entire device, including case 104, preforms 110a, and feedthrough assembly 102. In most instances, however, lasers 140 and 141 are not directed exclusively at preforms 110a, because if too much energy is focused directly at preforms 110a spattering of the material of preforms 110a will occur. In that situation, the seal between case 104 and feedthrough assembly 102 can be compromised.
Furthermore, although lasers 140 and 141 are illustrated “above” (relative to how illustrated in
In one embodiment, the space defined between outside surface 102b of feedthrough 102 and the adjacent portions of case 104 is controlled such that it remains relatively narrow in order to encourage good capillary action of molten preforms 110b. In one embodiment, the space between outside surface 102b of feedthrough 102 and the adjacent portions of case 104 is maintained between 10-50 μm. Where molten preforms 110b are a gold braze, this distance range provides a good capillary action for the braze to fill the space.
In one embodiment, lasers 140 and 141 are CO2 lasers controlled to heat the ceramic of insulator 112 to a high temperature above the melting point of preforms 110a. In one example, where preforms are gold braze, the lasers heat the insulator 112 well above the melting point of gold, that is, well above 1,064° C. In one embodiment, both the feedthrough assembly 102 and case 104 are preheated before application of laser energy from lasers 140 and 141, such as for example, in an oven. In one example, feedthrough assembly 102 and case 104 are preheated to a temperature of 600-800° C. before application of energy from lasers 140 and 141. In this way, less heating energy is needed from lasers 140 and 141 to melt preforms 110a. In some cases, if lasers 140 and 141 are used without first preheating in order to melt preforms 110a, such as all the way from room temperature, surface damage to insulators 112 can result because the energy needed from lasers 140 and 141 is much greater to maintain a high temperature to melt preforms 110a.
In one embodiment, feedthrough assembly 102, case 104 and preforms 110a are heated in a vacuum or in an inert gas. For example, feedthrough assembly 102, case 104 and preforms 110a are heated in argon gas in order to prevent oxidation of case 104, which is in one example, titanium. In one embodiment, feedthrough assembly 102, case 104 and preforms 110a are maintained in the vacuum or inert gas even during laser heating from lasers 140 and 141. In one embodiment, a vacuum/gas controlled sealed container or box is provided for heating feedthrough assembly 102, case 104 and preforms 110a. In one example, the box includes a window through which lasers 140 and 141 are directed in order to transmit light through to the feedthrough assembly 102, case 104 and/or preforms 110a.
Because conducting elements 114 are cermet embedded adjacent ceramic insulator 112, a hermetic seal therebetween is established without the use of braze or solder. In one embodiment, this assures that even where the entire feedthrough assembly 102 is heated to high temperatures, there is no concern of braze or solder reflowing, as there would be for conventional feedthrough assemblies (such as in
In one embodiment, braze 110 is controlled relative to feedthrough assembly 102 and case 104 in order to optimize its final configuration.
In this way, in one embodiment metallization 115 is stepped back slightly from the top and bottom surfaces 102a and 102c of feedthrough assembly 102 such that braze 110 will accordingly also be slightly offset. In one embodiment, metallization 115, and accordingly braze 110, is controlled to be 0.010 inches below the top surface 102a of feedthrough assembly 102 and 0.010 inches above the bottom surface 102c of feedthrough assembly 102. In one embodiment, this offset forms a superior seal between feedthrough assembly 102 and case 104.
At step 230, a laser is scanned over the surface of the insulator of the feedthrough assembly in order to bring up the temperature of the insulator. In one embodiment, the insulator is immediately adjacent the preform such that heating the insulator also heats the preform. In one embodiment, the laser is controlled to heat the ceramic a temperature above the melting point of the preforms. In one embodiment, where preforms are gold braze, the laser heat the insulator well above 1,064° C. In one embodiment, each of the feedthrough assembly, the case and the preform are first preheated before application of laser energy. In one example, the feedthrough assembly, case and preform are preheated to a temperature of 600-800° C. before application of energy from the laser.
At step 240, the laser continues to heat the feedthrough assembly, and in some instances the case and preform as well, such that the preform flows into the space between the feedthrough assembly and case. Once the space is filled, the laser is deactivated such that the molten preform solidifies thereby securing the feedthrough assembly to the case.
In one embodiment, feedthrough assembly 302, case 304, and preforms 310a are all secured and heated in sealed container 400. In one example, container 400 is vacuum-sealed and in another it is filled with an inert gas, such as argon. In one embodiment, container 400 includes window 402 through which lasers 340 and 341 are directed to heat feedthrough assembly 302, case 304 and/or preforms 310a. Once preforms 310a are in place, lasers 340 and 341 are directed at feedthrough 302 and activated. In one embodiment, lasers 340 and 341 are scanned across insulator 312, and particularly toward outside surface 302b, in order to heat up the ceramic in that area. In addition, preforms 310a are placed so that they are closely proximate to the outside surface 302b of feedthrough 302. As such, preforms 310a will begin to heat up from the adjacent heat from insulator 312.
In one embodiment, preforms 310a are gold braze placed relatively close to outside surface 302b of feedthrough 302. In one embodiment, lasers 340 and 341 heat feedthrough 302 to a temperature high enough so as to induce a temperature in preforms 310a above the melting point of gold. As such, preforms 310a will begin to melt and flow from the high temperature.
As with the embodiment described above, a single laser, or two or more lasers may be used. Also, the lasers can be directed toward outside surface 302b or can scan the entire top surface of feedthrough 302. Similarly to the previous embodiment, lasers can be directed at top surface 302b or directed at lower surface 302c of feedthrough 302.
In one embodiment, implantable medical device 100 of
Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.
