Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-08-16
2001-12-04
Schaetzle, Kennedy (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06327502
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is directed to a housing for an implantable stimulator, such as an implantable pacemaker, with at least one electrode connector for electrically and mechanically connecting the internal components of the stimulator to an electrode lead.
2. Description of the Prior Art
Implantable stimulators, such as a pacemaker, have a housing (also known as a “can”) which contains electronic circuitry and a power source (battery). The stimulator delivers stimulation energy, usually in the form of pulses, in vivo to tissue, such as cardiac tissue, via electrodes which are implanted so as to be in contact with the tissue. One or more electrode leads connect the stimulator to these electrodes. The leads must be mechanically and electrically connected to the housing. A single lead having multiple conductors, leading to respectively different electrodes, can be employed, or multiple leads can be used.
The internal components contained in the housing must be protected against the surrounding environment, especially body fluids, over a relatively long period of time. This requirement imposes high demands on all possible entry paths into the interior of the housing, and particularly on the connections of the leads to the housing. A fluid-type connection must be made between the lead or leads and the housing, but the connection must also afford the possibility to disconnect the stimulator housing from the implanted leads for replacement or servicing of the stimulator.
The connective parts of the stimulator and the leads have been substantially standardized in the pacing field, and generally a relatively deep female socket is used at the stimulator housing, which has a number of contact surfaces, and the lead or leads have a male portion carrying one or more corresponding, peripherally disposed, generally circular, contact surfaces.
Conventionally, the socket portion of the connection is made of a transparent material, usually epoxy resin, which is molded onto the stimulator housing, encompassing contacts which extend outwardly from the housing. The male portion of the lead is normally locked in this socket by set screws, although many other fastening arrangements are known in the art. The positioning and alignment of the different contact surfaces, and the positioning and alignment of the metallic threads for the set screws, prior to the molding of the female portion of the connector is relatively complicated, and there is also an unavoidable delay in the manufacturing process which arises due to the time needed for the epoxy resin to cure.
Moreover, since the connector is disposed at the top of the stimulator housing, the two halves of the housing which are joined together, after the circuit, power source and other components have been mounted therein, must necessarily be non-identical, and are usually mirror-symmetric. This requires that two differently shaped housing halves be manufactured and maintained in inventory.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a connector for an implantable stimulator device which can be assembled in the stimulator housing without the necessity of a molding procedure, which still providing the necessary fluid-tight mechanical and electrical connection of the electrode lead to the components contained in the stimulator housing.
The above object is achieved in accordance with the principles of the present invention in a connector for an electrode lead which is completely self-contained in an exterior tube, and which can be assembled, as a tubular unit, using two identical housing halves.
The entire assembly is prefabricated with an exterior tube, and it is then only necessary to weld the tube into or onto one of the housing halves. When two such prefabricated tubes are employed, the housing halves can be identical, and there is no need to separately manufacture, and maintain in inventory, two different, mirror-symmetrical, housing halves, as is necessary with conventional molded connections.
The electrical connection between the prefabricated tube and the hybrid substrate in the stimulator housing can be made directly, without the need for feed-throughs, by allowing the edge of the substrate to extend into a slot in the exterior tube, with the substrate being bonded thereto by welding, brazing or gluing. The substrate edge can be provided with contacts which may directly contact the contact pin of the lead, or can produce an electrical contact with the lead via an adapter. The two prefabricated tubes can then be attached to the substrate in advance so as to form a unit, and the entire unit then being placed in one housing half of the stimulator and connected to the battery, after which the other housing half is welded onto the first half. This is a considerable simplification over conventional procedures, wherein thin wires must be bonded to the feed-through block and to the substrate after mounting of the parts.
REFERENCES:
patent: 4545381 (1985-10-01), Bournay, Jr. et al.
patent: 4934366 (1990-06-01), Truex et al.
patent: 5324311 (1994-06-01), Acken
patent: 5411538 (1995-05-01), Lin
patent: 5906634 (1999-05-01), Flynn et al.
patent: 6029089 (2000-02-01), Hawkins et al.
Brand Paul
Froberg Paul
Hill Rolf
Jarl Per
Jergefalk David
Pacesetter AB
Schaetzle Kennedy
Schiff & Hardin & Waite
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