MANUFACTURING PROCESS IN CONNECTION WITH PACER CONNECTORS

Abstract: The present invention relates to a process for manufacturing a female connector for a pacer, comprising the steps of : forming a tubular ceramic insert with a longitudinal bore and with two radial holes connecting internal contact surfaces with external contact surfaces, filling said radial holes with conductive material, metallizing the internal and the external contact surfaces, covering said ceramic insert with a layer of metal except for an area around each of said external contact surfaces.

Description: Manufacturing process in connection with pacer connectors Field of the invention. The present invention relates to a method of manufacturing an internal connector part for a pacer. Background of the invention Implantable pacers normally comprise a pacer housing (also called can) containing electronic circuitry and a unit for electric power as well as different electrodes which are connected to the interior parts in the pacer housing and which are to be implanted in or in the vicinity of the heart. The electrodes are connected to the pacer by means of leads. The internal parts of the pacers have to be well protected against the internal environment, especially the body fluids in the body for a long period of time, which places strict requirements on all entries into the interior of the can and especially on the connections of the leads to the housing. At the same time it should be possible to disconnect the pacer from the implanted leads for replacement or servicing of the pacer. The connective parts of the pacer and the leads have largely been standardized so as to encompass a relatively deep female socket comprising a number of contact surfaces whereas the leads are provided with a male part comprising one or several corresponding peripheral, generally circular contact surfaces. At present the connective part of the pacer housing containing the female socket is made of a transparent material, normally of epoxy resin, which is molded onto the housing and onto contacts extending outwardly from the housing. The male part of the leads is normally locked by means of set-screws, although other fastening means have been envisaged. The positioning and alignment of the different contact surfaces and of the fastening means or metallic threads for the set screws prior to the molding of the connective part is however very complicated and the delay in the manufacturing process incurred by the curing of the epoxy resin is considerable. It would thus be desirable if the molding procedure could be dispensed with. It has been discussed that these complexities could be avoided by designing the pacer with a socket located inside the metal housing. To our knowledge this kind of sockets, sometimes termed "black holes", are not used at present. US-A-4, 934,366 and US-A-5, 324 , 311, both of which are incorporated by reference, describe two interior sockets or black holes for pacers. Both designs comprise a tubular member consisting of a number of alternating sections made of metal respectively of insulating ceramics. An end section of metal can be welded or bonded to an opening in the pacer housing by means of a flange. The use of different materials however set high standards in regard of precision and durability of the component parts and as well as on the assembly procedure thereof. This is especially important since the interior sockets must meet very high standards regarding the integrity of the interior of the pacer housing during long times of implantation in a demanding environment. The manufacture of these prior art sockets thus is relatively complicated. The same is valid for the device disclosed in US-A-4 , 262, 982, a ceramic socket combined with a metal flange for welding to a pacer housing and with a metallic interior contact pin. This device also comprises locking means in the form of an inwardly directed, circumferential rib located adjacent the opening of socket. This rib is intended to cooperate with barb-shaped sealing rings on the contact plug on the proximal end of the lead or catheter. Other connectors of the "black hole" type are disclosed in co-pending International Patent Applications No PCT/SE99/01383 and PCT/SE99/01893 assigned to the Assignee of the present invention. These connectors comprise a metallic tube containing a sintered ceramic plug with a longitudinal bore and a number of metallic contact surfaces in the form of metal rings and/or plugs molded into the ceramic materials. The object of the present invention is an alternative way of manufacturing connectors of this kind. Short description of the inventive concept This object is achieved by means of a process according to the appended main claim. Preferred embodiments are set forth in the dependent claims. Short description of the appended drawings Fig 1 shows a connector design with a ceramic plug and concentric metal rings; Fig 2 shows a connector of the general type shown on Fig 1, but manufactured in accordance with the present invention; Fig 3 is a section through the connector shown in Fig 2. Detailed description of preferred embodiments of the invention . Fig 1 shows a connector of the type comprising a tubular member 20 comprising a tube 21 of metal. The mid-section of the tube is provided with two relatively small lateral openings 24, 25. The openings 24, 25 are sealed by means of a ceramic plug 26 fitting snugly in the tube and soldered with gold or otherwise bonded against the inside of the tube. Two contact rings 27, 28 have been molded into the ceramic plug. The ceramic plug is provided with an interior bore corresponding to the shape of the proximal part of a standard male connector. The ceramic plug thus includes an interior sealing surface 53 for engagement with sealing rings on the male connector. The central part 30, 31 of the inside of the contact rings is not covered with the ceramic material. In this way two inner circumferential grooves are obtained in the inner bore of the ceramic plug. The bottom of the grooves consists of the metal in the contact rings. Two openings 32, 33 are also provided in the outer surface of the ceramic plug that may be made to coincide with the lateral openings 24, 25 in the tube wall. These openings give access to the contact rings 27, 28 when the ceramic plug has been mounted correctly in the tube 21. Leads for contacting the interior of the housing can be bonded to the parts of the contact rings 27, 28 accessible through the openings 24, 25 and 32, 33. Thus, when the ceramic plug 26 has been soldered or bonded into place, the openings 24, 25 will be completely sealed by the plug 26 although allowing electrical connection between the interior of the tube and the interior of the housing via the contact rings 27, 28. The inner end 23 of the tube 21 is closed by means of a ceramic plug 70 soldered into the tube. The plug 70 may be made in one piece with the plug 26 or, as illustrated, in a separate piece. The grooves 30, 31 contain spring contact rings 50, 51 of the same type as the ones described US-A-4 , 934 , 366. The locking means 40 but may, as illustrated, for instance be in the form of a resilient flange intended to engage a circumferential sealing ring on the male connector or may for instance be of the type disclosed in US-A-4 , 93 , 366. Fig 2 and 3 illustrate a connector manufactured in accordance with the present invention. The connector thus comprises a metal tube 121 having one open end 122 and a closed end 123. The metal tube contains a ceramic plug or insert 126 fitting snugly within the tube. In similarity with the embodiment described above, the insert 126 comprises a longitudinal bore, one end of which being closed. The bore also comprises two inner circumferential grooves 130, 131. The bottom surface of these grooves is provided with a metal layer 127, 128. The metal tube is provided with two lateral openings 124, 125 giving access to the outside of the ceramic insert 126. The ceramic insert is provided with two holes or vias 160, 161, each connecting a respective groove 130, 131 with the outer surface of the ceramic insert exposed in the lateral openings 124, 125. The holes are filled with conductive material, thus connecting the metal layer 127, 128 in a respective groove with a respective contact means 162, 163 located on the surface of the ceramic insert. The insert is made of an insulating ceramic material such as of alumina. In similarity with the design described in connection with Fig 1, the connector also is provided with a space 140 intended for a means for fixing a male lead connecting part in the connector as well as an interior sealing surface 153. The grooves 130, 131 preferably should contain a respective spring contact ring. These parts do however not form part of the present invention and are not described more closely. The process according to the invention for manufacturing the above connector comprises the following steps: -forming and sintering a tubular ceramic insert with a longitudinal bore with a contour corresponding to a male connector, preferably a standard IS-1 male connector, the bore also being provided with internal circumferential grooves, said insert also being formed with radial holes connecting said grooves with the exterior of the insert, -filling said radial holes in said insert with a conductive material, for instance by melting a solder paste into said holes -metallizing the bottoms of said grooves as well as an area around each of said radial holes -covering the exterior of said insert with a brazing or soldering agent with the exception of an area around each of said radial holes, for instance by metallizing or sputtering, -inserting said ceramic insert into a metal tube provided with lateral openings arranged to coincide with said holes in said insert when the insert is fully inserted, -brazing or soldering said insert to the inside of said metallic tube. As is evident from the above, the manufacturing process only involves the assembly of two simple parts, namely the metal tube and the ceramic insert, both being simple to manufacture . The forming of the ceramic insert may for instance by made by means of hot isostatic pressing on a core or mandrel made of a polymer or at least partly being made of a polymer. During the heating stage the polymer will be vaporized, thus allowing for the undercut interior grooves. If the same material is used for contact surfaces and for soldering, the application of soldering agent and of contact surfaces may be made in one single step. An alternative to filling the vias with a solder paste is to solder or braze a conductor into the vias. It might also be possible to design the tube initially without said lateral openings, the openings then being obtained by grinding or abrading parts of the metal so as o uncover the ceramic material in a circular groove around the radial holes in the ceramic insert whilst leaving some metal in the center to serve as a contact plate. The insertion of the ceramic insert into the metal tube might be facilitated if the tube is heated separately before the insertion of the ceramic insert. This would also allow for a very tight fit between insert and tube. In another embodiment the metallic tube might be dispensed with if the insert is metallized to a degree that is sufficient to ensure the structural integrity of the insert. In the above description of a preferred embodiment, the tube has been described as being open at one end only, i. e. that the connector will not go through the entire pacer housing when mounted therein. The invention is however also applicable to connectors with two opposite openings in which the space for the fixation means have been move to the opening opposite to the opening into which the male connector is to be inserted. The fixation means then would be accessible from the other end and could for instance engage the terminal end pin of the male connector. In this case, the bore in the ceramic insert would also have two opposing openings.

Claims: Claims 1. Process for manufacturing a female connector for a pacer, comprising the steps of - forming a tubular ceramic insert with a longitudinal bore and with two radial holes connecting internal contact surfaces with external contact surfaces, - filling said radial holes with conductive material, metallizing the internal and the external contact surfaces, - covering said ceramic insert with a layer of metal except for an area around each of said external contact surfaces . 2. Process according to claim 1, characterized in that said ceramic insert is covered with a soldering agent and inserted into a tube of metal, said metal tube being soldered or brazened to said insert. 3. Female connector manufactured in accordance with any one of the preceding claims.

Inventors: DAHLBERG KENNETH, DAHLBERG, KENNETH
Applicants: DAHLBERG KENNETH, ST JUDE MEDICAL, DAHLBERG, KENNETH, ST. JUDE MEDICAL AB
Application year: 2001
Main classification: A61N1
IPC codes: A61N1