The present invention relates to implantable medical devices, and more particularly to an improved design and method of construction and testing of a circuit board for an implantable medical device.
Implantable stimulation devices deliver electrical stimuli to nerves and tissues for the therapy of various biological disorders, such as pacemakers to treat cardiac arrhythmia, defibrillators to treat cardiac fibrillation, cochlear stimulators to treat deafness, retinal stimulators to treat blindness, muscle stimulators to produce coordinated limb movement, spinal cord stimulators to treat chronic pain, cortical and deep brain stimulators to treat motor and psychological disorders, and other neural stimulators to treat urinary incontinence, sleep apnea, shoulder subluxation, etc. The description that follows will generally focus on the use of the invention within a Spinal Cord Stimulation (SCS) system, such as that disclosed in U.S. Pat. No. 6,516,227. However, the present invention may find applicability with any implantable medical device or in any implantable medical device system.
An SCS system typically includes an Implantable Pulse Generator (IPG), whose structure and construction is further described in U.S. Provisional Patent Application No. 61/874,194, entitled “Construction for an Implantable Medical Device Employing an Internal Support Structure,” filed Sep. 5, 2013, which is incorporated herein by reference in its entirety. The IPG 10 of the '194 Application is shown in
Some of the construction steps of the IPG 10 are shown in
The inventors consider it desirable to electrically test the IPG PCB 42 before it is attached to the support structure 38 and electrically coupled to the battery 34 and feedthrough pins 48, and sealed within its case 30, and techniques are disclosed for doing so, which also involve improved designs and methods of constructing the IPG PCB 42.
Designs and methods of construction for a printed circuit board (PCB) in an implantable pulse generator (IPG) are disclosed which facilitate IPG PCB testing while also providing for protection of IPG circuitry in a simple and cost effective manner. The IPG PCB is formed as part of a larger test PCB, which includes an extender portion with traces routing nodes of interest in the IPG PCB to an edge connector. IPG electronics are mounted or soldered to the IPG PCB, and then such electronics are tested via the edge connector. The IPG PCB is then singulated from the extender portion in a manner leaving one or more PCB tabs at the severed edge of the PCB. The PCB tab(s) extend from the severed edge, and create an offset distance preventing traces severed and now exposed at the severed edge from contacting and potentially shorting to conductive structures in the IPG, such as a feedthrough.
The inventors consider it desirable to electrically test the IPG PCB 42 before it is attached to the support structure 38 and electrically coupled to the battery 34 and feedthrough pins 48, and sealed within its case 30, as explained earlier (
The edge connector 106's contacts 106a are of standard size and pitch to meet with corresponding contacts in an edge connector socket 112 coupled to a test system 110, which test system 110 can be of many different types used by a manufacturer. In one example, edge connector 106 and socket 112 comprise 80 pins, with 40 contacts 106a on the top and bottom of the extender PCB 104 (and in the socket 112), although not all of these pins would necessarily be used.
In one example, the test PCB 102, and hence the IPG PCB 42 and extender PCB 104, comprise a two-layer PCB in which two layers of conductive traces can be formed. However, this is not strictly necessary, and the numbers of layers needed in test PCB 102 will largely be dictated by the number of layers needed to interconnect the electrical components on IPG PCB 42. Additional layers needed by the IPG PCB 42, but not necessary to form traces 108 connecting the edge connector 106 with nodes of interest in the IPG PCB 42, may simply be unused in the extender PCB 104.
Thus, the electronic components needed to implement the functionality of the implantable medical device of the IPG PCB 42 (IPG 10) can be surface mounted or otherwise soldered to the IPG PCB 42 portion of the test PCB 102 in standard fashion, and then the edge connector 106 of the extender PCB 104 portion of the test PCB 102 can be inserted in the socket 112 associated with the test system 110 to test the IPG PCB 42 electronics.
As discussed above, nodes of interest in the IPG PCB 42 are routed via traces 108 to the edge connector 106 to allow such testing to occur. For example, the test system 110 can provide reference voltages to the nodes on IPG PCB 42 where the positive (Vbat) and negative (GND) battery terminals 46 will eventually be coupled, i.e., to battery terminal solder holes 52. As well as providing power to operate the IPG PCB 42 during the test, the test system 110 can also monitor the current drawn from node Vbat to verify whether significant leakage current is being drawn by the IPG PCB 42 indicative of a defect.
Traces 108 can also be connected to the electrode nodes (Ex) on the IPG PCB 42, i.e., to the feedthrough pin solder holes 54 to which the feedthrough pins 48 will eventually be connected, allowing these nodes to be coupled to the IPG electrodes 16. This is useful for example to allow the test system 110 to make sure the electrode electronics on IPG PCB 42 are not short or open circuited.
Other nodes of interest in the IPG PCB 42 may be routed via traces 108 as well, such as various bus signals on the IPG PCB 42 including control (C) and address/data (A/D) signals, which the tester can use to activate or monitor various modes of operation of the IPG PCB 42 circuitry. Other nodes of interest which may be routed include clock signals, other power supply or reference voltages, the nodes where the coil 40 will eventually be connected, i.e., to coil solder pin holes 50, etc. The signals shown in
Note that the traces 108 can pass anywhere between the IPG PCB 42 and the extender PCB 104, except in the location of PCB tabs 130, whose function is explained further below. Preferably, the traces 108 pass through a portion 132 between the two PCB tabs 130 that are shown, but this is not strictly necessary, and some traces are shown passing through portions 134 on the outsides of the PCB tabs 130.
After electronic testing is completed, and if proper operation of the IPG PCB 42 is confirmed, the IPG PCB 42 is singulated from the PCB extender 104 along sever line 114, and the PCB extender 104 portion of test PCB 102 can then be disposed of. In one example, a Computer Numerical Control (CNC) router or milling machine is used to cut (e.g., saw) the IPG PCB 42 from the extender PCB 104, with a Computer Aided Design (CAD) file used to guide the router's cutting element along sever line 114 so as to define the shape of the PCB tabs 130. Other methods of singulating the IPG PCB 42 may also be used, such as manual breaking, v-score shearing, nibbling, punching, etc. Note that while the sever line 114 may be perforated or scored on the test PCB 102, this is not strictly necessary, particularly if cutting is used for singulation.
Shorting of the severed traces 108′ is especially concerning for the design of IPG 10 given the proximity of severed edge 114′ of IPG PCB 42 to the feedthrough 32, as shown in
While an insulator could be applied to the severed edge 114′ to cover the severed traces 108′, such as additional manufacturing step is not desired, as it would raise the risk of damaging the IPG PCB 42 or introducing new defects.
Instead, and in accordance with an aspect of the invention, at least one PCB tab 130 is provided along the severed edge 114′ of the side of the IPG PCB 42, and two such tabs 130 are shown in
Because the particular concern for IPG 10 is the shorting of severed traces 108′ to the feedthrough 32, the PCB tabs 130 are located near to the ends of the feedthrough 32 along its length as shown in
The operation of PCB tab(s) 130 are shown in further detail in the magnified view of
PCB tab(s) 130 prevent this from occurring. Notice that the PCB tabs 130 extend perpendicularly from the severed edge 114′ by an offset distance of x, which distance x is designed to be larger than a longest expect length y of any severed trace 108′ or unwanted particulate. This recesses the severed traces 108′, and guarantees that the distance w between the severed traces 108′ and the feedthrough 32 will never be smaller than x, and thus w will always be greater than y. As a result, no severed trace 108′ can touch the feedthrough 32. Distance x in one example is 0.005 inches (5 mils).
If d1 and/or d2 are unusually large, the natural resting position of the feedthrough 32 relative to the IPG PCB 42 may be such that the feedthrough 32 does not touch the surface of the PCB tab(s) 130. In other words, w would be bigger than x, and a gap may exist between the feedthrough 32 and the top of the PCB tab(s) 130 as shown, which condition does not raise the risk of shorting the severed traces 108′. However, if d1 and/or d2 are unusually small, the feedthrough 32 would contact the top of the PCB tab(s) 130, thus limiting w to x. If w is naturally small by virtue of how the feedthrough pins 48 are bent, offset distance x may force the ends of the feedthrough pins 48 to bend in the feedthrough pin solder holes 54 from their otherwise natural resting positions, but this is not problematic. In effect, PCB tab(s) 130 force an air gap inside of the IPG case 30 to exist between the severed traces 108′ and the feedthrough 32, which prevents their shorting. Thus, PCB tab(s) 130 eliminate the need for additional insulation or spacers at the severed edge 114′, and provide a simple and cost-effective solution to isolate severed traces 108′.
As noted earlier, it is preferred that none of the traces 108 passing between the extender PCB 104 and the IPG PCB 42 pass through the portion(s) where the PCB tab(s) 130 will be formed. This is because PCB tab(s) 130 may contact the feedthrough 32 as just noted, and thus any severed traces passing through PCB tab(s) 130 might be shorted. However, traces 108 may pass through the portion 134 outside of the PCB tab(s) 130. As shown in
Other modifications can be made to affect the goal of preventing severed traces from contacting conductive structures in the IPG. For example, in
It should be noted that while the present invention was contemplated given the particular geometry of the IPG 10 in which the severed edge 114′ of the IPG PCB 42 is close to the feedthrough 32, severed edges formed as disclosed herein may run the risk of shorting to any conductive structures 150 in an IPG or other medical device, such as the case 30, another PCB, other electrical components or wires, etc. The PCB tab(s) 130 and/or PCB recess(es) 140 can also be used to prevent shorting of the severed traces 108′ to such other conductive structures 150. Indeed, the disclosed techniques can have applicability outside of medical devices.
Although particular embodiments of the present invention have been shown and described, it should be understood that the above discussion is not intended to limit the present invention to these embodiments. It will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present invention. Thus, the present invention is intended to cover alternatives, modifications, and equivalents that may fall within the spirit and scope of the present invention as defined by the claims.
This is a non-provisional of U.S. Provisional Patent Application Ser. No. 61/902,062, filed Nov. 8, 2013, to which priority is claimed, and which is incorporated herein by reference in its entirety.
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