Ultrasonically welded, staked or swaged components in an implantable medical device

Abstract

The present invention generally relates to implantable medical devices and more particularly to various means for ultrasonically welding, swaging or staking various components in an implantable medical device, most preferably by employing appropriately configured covers or lids. Covers or lids are attached to header or connector modules mounted on an hermetically enclosed and sealed enclosure, where the connector or header module and enclosure comprise an implantable medical device. The covers or lids preferably trap or otherwise secure any of a number of various connector or header module components within the header or connector modules. Examples of such trapped or secured components include grommets, set screw connector blocks, seals, feedthrough wires, multi-beam contacts, electrical contacts, antennas, radio-opaque markers, connector ribbons and the like.

We claim:  
     
         1 . A method of securing at least one component or part within a recess disposed in a pre-formed header or connector module having an outer surface and formed of a thermoplastic material, the module being attached to an hermetically sealed enclosure, the recess being defined by an inner surface disposed therewithin and an outer periphery contiguous with the outer surface, the outer periphery being propinquant to or contiguous with a first mating surface disposed near or in the recess, at least portions of the recess being configured to receive the part or component therewithin, a cover or lid having a second mating surface for engaging the first mating surface, the cover or lid being formed of thermoplastic material, the cover or lid matingly engaging and covering the recess when the first surface is brought into contact with the second mating surface and ultrasonically welded thereto, comprising the steps of: 
 providing the pre-formed module;    forming the recess within the module;    disposing the part or component within the recess;    aligning the first mating surface of the recess with the second mating surface of the cover;    seating the cover or lid over the recess and the part or component such that at least portions of the first and second mating surfaces are propinquant to or in contact with one another, and    ultrasonically welding the cover to the header or connector module in the region of the first and second mating surfaces to form melted thermoplastic material in the vicinity of the first and second mating surfaces.    
     
     
         2 . The method of    claim 1   , wherein a step of applying medical adhesive in at least portions of the recess precedes the placing and ultrasonically welding steps.  
     
     
         3 . The method of    claim 1   , wherein the ultrasonic welding step further comprises applying ultrasonic energy having an amplitude and duration sufficient to cause adjoining thermoplastic material in the first and second mating surfaces to melt and flow into intimate engagement with one another.  
     
     
         4 . The method of    claim 1   , further comprising the step of cooling the melted thermoplastic material until it solidifies and prevents or impedes the separation of the cover from the connector or header module.  
     
     
         5 . The method of    claim 1   , wherein the component or part is one of a set-screw connector block, a grommet, a multi-beam connector, an electrical connector, a radio-opaque marker, a feedthrough wire and a seal.  
     
     
         6 . The method of    claim 1   , wherein the header or connector module is formed of at least one of polyurethane and polysulfone.  
     
     
         7 . The method of    claim 1   , wherein the implantable medical device is one of an IPG, a pacemaker, a PCD, a defibrillator, an ICD, a nerve stimulator, a muscle stimulator, a monitoring device and a subcutaneous monitoring device.  
     
     
         8 . The method of    claim 1   , wherein the first and second mating surfaces form at least one of corresponding and matingly engaging tongue and groove joints, step joints, textured surfaces, criss-cross joints and shear joints.  
     
     
         9 . An implantable medical device, comprising: 
 (a) a part or component;    (b) a pre-formed header or connector module having an outer surface and formed of a thermoplastic material, the module having a recess disposed therewithin, the recess being defined by an inner surface and an outer periphery contiguous with the outer surface, the outer periphery being propinquant to or contiguous with a first mating surface disposed near or in the recess, at least portions of the recess being configured to receive the part or component therewithin;    (c) an hermetically sealed enclosure attached to the module, and    (d) a cover or lid having a second mating surface for engaging the first mating surface, the cover or lid being formed of thermoplastic material, the second mating surface of the cover or lid being aligned with and matingly engaging at least portions of the first mating surface of the recess, the cover covering the recess and being ultrasonically welded to the connector or header module such that melted thermoplastic material resides in or near the region of the first and second mating surfaces.    
     
     
         10 . The device of    claim 9   , wherein a medical adhesive is disposed between the cover and at least portions of the recess.  
     
     
         11 . The device of    claim 9   , wherein the first and second mating surfaces have melted and flowed into intimate engagement with one another.  
     
     
         12 . The device of    claim 9   , wherein the cover is firmly attached to the connector or header module.  
     
     
         13 . The device of    claim 9   , wherein the component or part is one of a set-screw connector block, a grommet, a multi-beam connector, an electrical connector, a radio-opaque marker, a feedthrough wire and a seal.  
     
     
         14 . The device of    claim 9   , wherein the header or connector module is formed of at least one of polyurethane and polysulfone.  
     
     
         15 . The device of    claim 9   , wherein the implantable medical device is one of an IPG, a pacemaker, a PCD, a defibrillator, an ICD, a nerve stimulator, a muscle stimulator, a monitoring device and a subcutaneous monitoring device.  
     
     
         16 . The device of    claim 9   , wherein the first and second mating surfaces form at least one of corresponding and matingly engaging tongue and groove joints, step joints, textured surfaces, crisscross joints and shear joints.  
     
     
         17 . An implantable medical device, comprising: 
 (a) means for forming a part or component;    (b) means for forming a pre-formed header or connector module having an outer surface and formed of a thermoplastic material, the module forming means having means for forming a recess disposed therewithin, the recess forming means being defined by an inner surface and an outer periphery contiguous with the outer surface, the outer periphery being propinquant to or contiguous with a first means for mating near or in the recess, at least portions of the recess forming being configured to receive the part or component forming means therewithin;    (c) means for forming an hermetically sealed enclosure attached to the module forming means, and    (d) means for forming a cover or lid having a second means for mating and engaging the first mating means, the cover or lid forming means being formed of thermoplastic material, the second mating means of the cover or lid forming means being aligned with and matingly engaging at least portions of the first mating means of the recess forming means, the cover forming means covering the recess forming means and being ultrasonically welded to the connector or header module forming means such that melted thermoplastic material resides in or near the region of the first and second mating means.    
     
     
         18 . The device of    claim 17   , wherein a medical adhesive is disposed between the cover and at least portions of the recess.  
     
     
         19 . The device of    claim 17   , wherein the first and second mating surfaces have melted and flowed into intimate engagement with one another.  
     
     
         20 . The device of    claim 17   , wherein the component or part is one of a set-screw connector block, a grommet, a multi-beam connector, an electrical connector, a radio-opaque marker, a feedthrough wire and a seal.  
     
     
         21 . The device of    claim 17   , wherein the implantable medical device is one of an IPG, a pacemaker, a PCD, a defibrillator, an ICD, a nerve stimulator, a muscle stimulator, a monitoring device and a subcutaneous monitoring device.  
     
     
         22 . The device of    claim 17   , wherein the first and second mating surfaces form at least one of corresponding and matingly engaging tongue and groove joints, step joints, textured surfaces, crisscross joints and shear joints.