Abstract:
A group select matrix is added to an implantable stimulator device to allow current sources to be dedicated to particular groups of electrodes at a given time. The group select matrix can time multiplex the current sources to the different groups of electrodes to allow therapy pulses to be delivered at the various groups of electrodes in an interleaved fashion. Each of the groups of electrodes may be confined to a particular electrode array implantable at a particular non-overlapping location in a patient&#39;s body. A switch matrix can be used in conjunction with the group select matrix to provide further flexibility to couple the current sources to any of the electrodes.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This is a non-provisional of U.S. Provisional Application Ser. No. 61/502,409, filed Jun. 29, 2011, which is incorporated herein by reference, and to which priority is claimed. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to implantable medical devices, and more particularly to improved current source architectures for an implantable neurostimulator. 
     BACKGROUND 
     Implantable neurostimulator devices are devices that generate and deliver electrical stimuli to body 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. 
       FIGS. 1A and 1B  shows a traditional Implantable Pulse Generator (IPG)  100 , which includes a biocompatible device case  30  formed of a conductive material such as titanium for example. The case  30  typically holds the circuitry and a battery necessary for the IPG  100  to function, although IPGs can also be powered via external RF energy and without a battery. The IPG  100  includes in this simple example an electrode array  102  containing a linear arrangement of electrodes  106 . The electrodes  106  are carried on a flexible body  108 , which also houses the individual electrode leads  112  coupled to each electrode. In the illustrated embodiment, there are eight electrodes on array  102 , labeled E 1 -E 8 , although the number of electrodes is application specific and therefore can vary. Array  102  couples to case  30  using a lead connector  38 , which is fixed in a non-conductive header material  36  such as epoxy for example. As is well known, the array  102  is implanted in an appropriate location in a patient to provide suitable simulative therapy, and is coupled through the patient&#39;s tissue to the IPG  100 , which may be implanted somewhat distant from the location of the array. 
     As shown in  FIG. 1B , the IPG  100  typically includes an electronic substrate assembly  14  including a printed circuit board (PCB)  16 , along with various electronic components  20 , such as microprocessors, integrated circuits, and capacitors mounted to the PCB  16 . Two coils (more generally, antennas) are generally present in the IPG  100 : a telemetry coil  13  used to transcutaneously transmit/receive data to/from an external controller (not shown); and a charging coil  18  for transcutaneously charging or recharging the IPG&#39;s battery  26  using an external charger (also not shown). 
     A portion of circuitry  20  in the IPG  100  is dedicated to the provision of therapeutic currents to the electrodes  106 . Such currents are typically provided by current sources  150 , as shown in  FIGS. 2A and 2B . In many current-source based architectures, some number of current sources  150  are associated with a particular number of electrodes  106 . For example, in  FIG. 2A , it is seen that N electrodes E 1 -E N  are supported by N dedicated current sources  150   1 - 150   N . In this example, and as is known, the current sources  150  are programmable (programming signals not shown) to provide a current of a certain magnitude and polarity to provide a particular therapeutic current to the patient. For example, if source  150   2  is programmed to source a 5 mA current, and source  150   3  is programmed to sink a 5 mA current, then 5 mA of current would flow from anode E 2  to cathode E 3  through the patient&#39;s tissue, R, hopefully with good therapeutic effect. Typically such current is allowed to flow for a duration, thus defining a current pulse, and such current pulses are typically applied to the patient with a given frequency. If the therapeutic effect is not good for the patient, the electrodes chosen for stimulation, the magnitude of the current they provide, their polarities, their durations, or their frequencies could be changed. 
     ( FIG. 2A  shows that each of the electrodes is tied to a decoupling capacitor. As is well known, decoupling capacitors promote safety by prevent the direct injection of current form the IPG  100  into the patient. For simplicity, decoupling capacitors are not shown in subsequent drawings, even though they are typically present in practical implementations). 
       FIG. 2B  shows another example current source architecture using a switch matrix  160 . In this architecture, the switch matrix  160  is used to route current from any of the sources  150   P  to any of the electrodes E N . For example, if source  105   2  is programmed to source a 5 mA current, and source  105   1  is programmed to sink a 5 mA current, and if source  150   2  is coupled to electrode E 2  by the switch matrix  160 , and if source  150   1  is connected to electrode E 3  by the switch matrix  160 , then 5 mA of current would flow from anode E 2  to cathode E 3  through the patient&#39;s tissue, R. In this example, because any of the current sources  150  can be connected to any of the electrodes, it is not strictly required that the number of electrodes (N) and the number of current sources (P) be the same. In fact, because it would perhaps be rare to activate all N electrodes at once, it may be sensible to make P less than N, to reduce the number of sources  150  in the IPG architecture. This however may not be the case, and the number of sources and electrodes could be equal (P=N). Although not shown, it should be understood that switch matrix  160  would contains P×N switches, and as many control signals (C 1,1 -C P,N ), to controllably interconnect all of the sources  150   P  to any of the N electrodes. Further details of a suitable switch matrix can be found in U.S. Patent Pub. U.S. Patent Publication 2007/0038250, which is incorporated herein by reference. 
     The architecture of  FIG. 2B , like the architecture of  FIG. 2A , also comprises some number of current sources  150  (P) associated with a particular number of electrodes  106  (N). Other more complicated current architectures exist in the implantable stimulator art. See, e.g., the above-incorporated &#39;250 Publication. But again generally such approaches all require some number of current sources  150  to be associated with a particular number of electrodes  106 . 
     The inventor considers the association of numbers of current sources and electrodes to be limiting because such architectures do not easily lend themselves to scaling. As implantable stimulator systems become more complicated, greater numbers of electrodes will provide patients more flexible therapeutic options. However, as the number of electrodes grows, so too must the number of current sources according to traditional approaches discussed above. This is considered undesirable by the inventor, because current source circuitry—even when embodied on an integrated circuit—is relatively large and complicated. Newer architectural approaches are thus believed necessary by the inventor to enable the growth of more complicated implantable stimulator systems, and such new architectures are presented herein. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A and 1B  show an implantable pulse generator (IPG), and the manner in which an electrode array is coupled to the IPG in accordance with the prior art. 
         FIGS. 2A and 2B  show traditional current source architectures for an IPG in accordance with the prior art. 
         FIG. 3  shows an IPG in accordance with an embodiment of the invention in which a plurality of electrodes are grouped and provided at different locations in a patient. 
         FIGS. 4A and 4B  show different current source architectures in accordance with embodiments of the invention to support the IPG of  FIG. 3 . 
         FIGS. 5, 6A and 6B  show timing diagrams for operating the IPG of  FIG. 3 . 
         FIG. 7  shows logic for enabling the current source architectures described herein. 
         FIGS. 8A and 8B  show alternative arrangements for grouping of electrodes in an IPG in accordance with embodiments of the invention. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 3  shows a more complicated IPG  200  which contains a higher number of electrodes than that illustrated earlier, and which may be indicative of the future progress of IPG technology. In the example shown, there are three electrode arrays  102   1 - 102   3 , each containing eight electrodes, with electrodes E 1 -E 8  on array  102   1 , E 9 -E 16  on array  102   2 , and E 17 -E 24  on array  102   3 . Each of the arrays  102  couples to the IPG  200  at a suitable lead connector  38   1 - 38   3 , which lead connectors can be arranged in the header  36  in any convenient fashion. It should be understood that this is merely an example, and that different numbers of arrays, and different numbers of electrodes on each array, could be used. 
     In this example, each of the arrays  102   1 - 102   3  comprises a group of electrodes that is implanted (or implantable) in a different location in a patient&#39;s body, thus allowing for the provision of complex stimulation patterns and/or stimulation across a wider portion of the patient&#39;s body. For example, in a therapy designed to alleviate sciatica, Location  1  for the Group  1  electrodes of array  102   1  (E 1 -E 8 ) might comprise the patient&#39;s right leg; Location  2  for the Group  2  electrodes of array  102   2  (E 9 -E 16 ) the left leg; and Location  3  for the Group  3  electrodes of array  102   3  (E 17 -E 24 ) the patient&#39;s spinal column. In a therapy designed to alleviate lower back pain, Location  1  of Group  1  might comprise the right side of a patient&#39;s spinal column; Location  2  of Group  2  the left side of the spinal column; and Location  3  of Group  3  a central location in the spinal column. Or each of Locations  1 - 3  may comprise different portions of a patient&#39;s brain in a deep brain stimulation example. The exact locations of each of the arrays, the number of electrodes in each array, and the particular therapies they provide, are not important to the concepts discussed herein. It is preferred that the Locations are non-overlapping in the patient&#39;s body. 
     As discussed in the Background section, conventional wisdom suggests that tripling the number of electrodes (from eight to 24 in this example) would require tripling the number of current sources in the IPG  200  used to support those electrodes. This is because conventional approaches associate a number of current sources with a particular number of electrodes, and hence the two would scale. As noted earlier, the inventor finds this unfortunate given the complexity and size of typical current course circuitry. 
     The present current source architecture diverges from this conventional approach by sharing current sources with an increased number of electrodes, such as is shown first in  FIG. 4A . Consistent with  FIG. 3 , 24 total electrodes are supported by the current source circuitry of  FIG. 4A , comprising three arrays  102   1 - 102   3  (e.g., Groups) present in three different Locations in the body.  FIG. 4A  is somewhat similar to the architecture of  FIG. 2A  discussed earlier, in that there is a one-to-one correspondence of current sources  150  to electrodes within a given Group. For example, there are eight current sources  150 , and eight electrodes in each Group. New to  FIG. 4A  is a group select matrix  170 . The group select matrix  170  allows current from the current sources  150  to be sent to particular electrodes in each of the Groups. For example, current source  150   1  can send its current to electrode E 1  in Group  1 , to E 9  in Group  2 , and to E 17  in Group  3 . Current source  150   2  can send its current to E 2  in Group  1 , to E 10  in Group  2 , and E 18  in Group  3 , etc. 
     Group control is enabled in this example by the use of three group control signals G 1 -G 3 . When G 1  is asserted, switches (e.g., transistors) in the group switch matrix  170  are closed to respectively route the current from each of the current sources  150   1 - 150   8  to Group  1  electrodes E 1 -E 8 . (Of course, not all of the current sources  150   1 - 150   8  may be programmed at a given moment to provide a current, and so current will not necessarily flow at an electrode E 1 -E 8  merely because of the assertion of G 1 ). When G 2  is asserted, each of the current sources  150   1 - 150   8  are coupled to Group  2  electrodes E 9 -E 16 , and likewise when G 3  is asserted, each of the current sources  150   1 - 150   8  are coupled to Group  3  electrodes E 17 -E 24 . Although shown as switches, it should be understood that the group switch matrix  170  may also comprise a plurality of multiplexers. 
     Assume electrode E 13  is to output 5 mA of current while electrode E 12  is to receive that 5 mA of current. In this example, source  150   5  is programmed to source 5 mA worth of current, source  150   4  is programmed to sink 5 mA of current, and group control signal G 2  is asserted. 
     With this architecture, there is no need to scale the number of current sources; for example, the number of current sources  150  in this example equals eight, even though 24 electrodes are supported. A fourth group of electrodes (e.g., E 25 -E 32 ) could also be supported by these same eight current sources, etc. This is of great benefit, and conserves current source resources with the IPG  200 . 
       FIG. 4B  shows another current source architecture employing a group select matrix  170 . The architecture of  FIG. 4B  is somewhat similar to the architecture of  FIG. 2B  discussed earlier in that it uses a switch matrix  160  to associate P current sources  150   1 - 150   P  with a number of switch matrix outputs equal to the number of electrodes (N=8) in each Group. The switch matrix  160  thus allows the current of any of the current sources  150   1 - 150   P  to be presented at any of the switch matrix  160  outputs, and the group select matrix  170  then routes those outputs to particular electrodes in the selected group. 
     Assume again that electrode E 13  is to output 5 mA of current while electrode E 12  is to receive that 5 mA of current. In this example, any of the P sources can be chosen to source and sink the current; assume that source  150   1  will source the current, while source  150   2  will sink the current. Electrode control signals C 1,5  and C 2,4  are asserted to close the necessary switches (not shown) in the switch matrix  160  to respectively connect source  150   1  to the fifth switch matrix output, and source  150   2  to the fourth switch matrix output. Then group control signal G 2  is asserted to respectively route those switch matrix outputs to electrodes E 13  and E 12 . 
       FIG. 5  shows examples of therapies that can be enabled using the current source architectures of  FIG. 4A or 4B . As before, three arrays of electrodes, defining three Groups, are used to provide therapy to three different Locations in the patient. Assume that the therapies appropriate at each of these Locations have already been determined. For example, assume that at Location  1  it has been determined to source current from electrode E 3  and to sink that current from electrodes E 2  and E 4 , and to do so at particular magnitudes and durations t d  which are unimportant for purposes of this example. Assume further that such therapy is to be provided at a frequency of f as shown. Assume further that at Location  2  it has been determined to sink current from electrode E 11  and to source that current from electrodes E 10  and E 12 , again at a frequency of f. Assume still further that at Location  3  it has been determined to source current from electrode E 18  and to sink that current from electrode E 19 , again at a frequency of f. 
     If the architecture of  FIG. 4A  is used, such therapy can be delivered as shown in  FIG. 5 . As shown, the therapies at each of the Locations are interleaved, so that the various therapies are non-overlapping. This allows the current sources  150  to be shared and activated in a time-multiplexed fashion, first being dedicated to provision of therapy at Location  1 , then Location  2 , then Location  3 , and back to Location  1  again, etc. Assume that the architecture of  FIG. 4A  is used, in which there is a one-to-one correspondence of current sources  150   1 - 150   8  to electrodes within a given Group, i.e., at a particular Location. In this instance, current sources  150   2 - 150   4  are used to provide the therapy to electrodes E 2 -E 4  in Group  1 /Location 1 . Notice that group control signal G 1  is asserted during this time as shown in  FIG. 5 . Then later, for example, after a recovery period t as discussed further below, these same current sources  150   2 - 150   4  are used to provide therapy to electrodes E 10 -E 12  in Group  2 /Location  2 , but this time with group control signal G 2  asserted. Again after another recovery period, two of these three same current sources  150   2 - 150   3  are used to provide the therapy to electrodes E 18  and E 19  in Group  3 /Location  3 , but this time with group control signal G 3  asserted. To summarize, by interleaving the therapy pulses at the different Groups/Locations, the current sources  150  can be shared and do not have to be increased in number to support the increased number of electrodes. 
     As is well known, stimulation pulses such as those shown in  FIG. 5  would normally be followed by pulses of opposite polarity at the activated electrodes, and even thereafter additional steps may be taken to reduce the build-up of injected charge or to prepare for the provision of the next stimulation pulse. Such portions of time may be referred to generally as a recovery phase, and are shown in  FIG. 5  as taking place during a time period t rp . It is preferable to not issue a next stimulation pulse until the preceding recovery phase is completed. The details of what occurs during the recovery phases are not shown in  FIG. 5  for simplicity. 
     The extent to which therapies at different Locations can be interleaved will depend on several factors, such as the frequency f of simulation, the duration of the stimulation pulses t d , and the duration of the recovery periods t rp . For interleaving and sharing of current sources to occur as shown, these various timing periods should not be in conflict so that access to the current sources can be time multiplexed. 
     That being said, modifications can be made in the disclosed technique to accommodate at least some potential conflicts. For example, as shown in  FIG. 6A , it is seen that the frequency of the therapy provided to the electrodes in Group  2 /Location  2  is different (f 2 ) from the frequency provided at the electrodes in Group  1 /Location  1  and Group  3 /Location  3  (f 1 ). This at times crates periods of conflict, t c , where the Group  2 /Location  2  stimulation may overlap with stimulation in other Groups/Locations. For example, specifically shown in  FIG. 6A  is a conflict between Group  2 /Location  2  and Group  1 /Location  1 , where both of these Groups/Location would be calling for support from the same current sources  150   2 - 150   4 . In this circumstance, and assuming the conflict would not occur too often, the logic  250  in the IPG  200  (discussed below with reference to  FIG. 7 ) may decide to arbitrate the conflict by allowing only the Group  1 /Location  1  electrodes access to the desired current sources  150   2 - 150   4 . In other words, the Group  2 /Location  2  electrodes would simply not be pulsed during the conflict, as represented by dotted lies in  FIG. 6A . Again, assuming such conflicts will not occur frequently, occasionally missing a stimulation pulse at a Group/Location should not materially affect patient therapy. Also, the downside to such therapy gaps can be alleviated by alternating the Groups/Locations being allowed access to the current sources during a conflict, e.g., by enabling Group  1 /Location  1  at a first instance of conflict, Group  2 /Location  2  at a second instance of conflict, Group  1 /Location  1  at a third instance of conflict, etc. 
     Conflicts of this type can also be resolved in different ways depending on the current source architecture used.  FIG. 6B  shows the same conflict between Group  1 /Location  1  and Group  2 /Location  2  presented in  FIG. 6A . However, here the logic  250  in the IPG resolves the conflict not by sharing current sources, but instead providing different current sources to Group  1 /Location  1  and Group  2 /Location  2 . Of course, this assumes a more flexible architecture is used in which current sources can be freely assigned to particular electrodes, such as the architecture of  FIG. 4B  employing a switch matrix  160 . Recognizing the conflict, the logic  250  assigns current sources  150   1 ,  150   5 , and  150   6  to electrodes E 10 , E 11 , and E 12  in Group  2 /Location  2 , rather than the current sources that might otherwise be expected (i.e., sources  150   2 - 150   4 ) which are instead assigned to the electrodes in Group  1 /Location  1 . Note that during the conflict both group control signals G 1  and G 2  can be asserted. Note also that current sources  150   2 - 150   3  are also assigned to the electrodes in Group  3 /Location  3 , which is possible because there is no conflict between Group  1 /Location  1  and Group  3 /Location  3 . 
     As noted above, control of the various current source architectures disclosed herein can be achieved by suitably programmed logic circuitry  250 , as shown in  FIG. 7 . Logic  250  in one example can comprise a microcontroller, as is common in an IPG. While the microcontroller  250  can implement many different IPG functions, as relevant here the microcontroller is responsible for processing one or more stimulation programs  255  dictating therapy for a patient, and for enabling the current sources and groups accordingly. In one embodiment, the stimulation program  255  comprises separate stimulation programs for each Group/Location, which specific programs may have been arrived at through a fitting procedure during which the patient expresses his preference for particular settings. As shown, the microcontroller  250  ultimately issues commands to the current source architecture at appropriate times, including enabling particular current sources  150 , and specifying the magnitude, polarity, and duration of the current pulses. Also ultimately issued by the microcontroller  250  are the group control signals (G 1 , G 2 , etc.), which are received at the group select matrix  170 . If the current source architecture employs a switching matrix  160  as shown and described in  FIG. 4B  for example, the microcontroller  250  can also issue the control signals for that matrix (C 1,1 -C P,N ). To the extent that the stimulation program  255  presents a conflict, such as those discussed earlier with respect to  FIGS. 6A and 6B , special arbitration logic  260  may be used to resolve the conflict, such as by skipping certain stimulation pulses ( FIG. 6A ), rerouting alternative current sources  150  if possible ( FIG. 6B ), or in other ways. 
     To this point it has been assumed that Groups/Locations of electrodes correspond to particular arrays  102  coupled to the IPG. But this is not necessarily the case, and groups of electrodes and their locations can be established in other ways. For example,  FIG. 8A  shows a single electrode arrays having 24 electrodes, divided into three Groups of eight. Each of these Groups corresponds to a different Location for therapy, even though present on the same array  102 , and thus this type of electrode grouping arrangement can still benefit from the current source architectures described herein. For example, eight current sources  150  can be employed if the architecture of  FIG. 4A  is used, or P current sources if the architecture of  FIG. 4B  is used.  FIG. 8B  shows another example in which a plurality of arrays ( 102   1  and  102   2 ) are treated as one Group of eight electrodes, even though such arrays would not be at exactly the same location in the patient. Nonetheless, the 24 electrodes present in  FIG. 8B  can be supported by eight current sources ( FIG. 4A ) or P current sources ( FIG. 4B ). 
     It should be understood that a “current source” comprises any type of power source capable of delivering a stimulation current to an electrode, such as a constant current source, a constant voltage source, or combinations of such sources. 
     A “microcontroller” should be understood as any suitable logic circuit, whether integrated or not, or whether implemented in hardware or software. 
     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.