Patient device for bidirectional data communication with an implant

Abstract
A patient device (PD) for wireless data communication with an implant. The PD can be at least in an unpaired state or a paired state. In the paired state the PD is paired to a specific implant specified by an implant's identification code (IIC). The IIC is stored in PD memory. Automatic pairing of the PD to a specific implant is performed upon receiving an incoming data packet containing an IIC when the PD is in its unpaired state with no valid IIC stored in memory. Thus, the PD is tentatively paired to an implant identified by the IIC contained in the incoming data packet by storing the IIC in the memory. Tentative pairing is cancelled if no further communication occurs within a predetermined period of time. A soft paired state is entered if further data communication does occur.
Description

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features and advantages of the present invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings wherein:



FIG. 1 shows a system comprising an implantable pacemaker, a patient device and a programmer, the patient device being represented by a schematic block diagram showing the main features of the patient device being of importance with respect to a preferred embodiment of the invention.



FIG. 2 is a state diagram of the patient device illustrating the functional behavior of the patient device.





DETAILED DESCRIPTION

The following description is of the best mode presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention. The scope of the invention should be determined with reference to the claims.


In FIG. 1, a patient device 10 is depicted in an environment also comprising an implant 12 and a programmer 14.


Patient device 10 is a patient device comprising—among other features of no particular interest for the present invention—a patient device transceiver eTRX, connected to an antenna 20 and to a patient device control unit eCTRL. Control unit eCTRL is connected to a timer 22 and to a patient device memory eMEM. Memory eMEM comprises program or instruction data defining an assignment procedure to be carried out by the control unit eCTRL and the patient device during pairing of patient device 10 to an implant. Memory eMEM also comprises dedicated address space for storing an implant identification code IID.


Control unit eCTRL further is connected to a patient device read only memory eROM comprising the patient devices identification code EID (external device ID).


The implant also comprises a memory iMEM, that preferably is a read only memory ROM for storing an implant identification code IID, a control unit iCTRL connected to the implant's memory iMEM and a transceiver iTRX for bidirectional data communication with the patient device 10.


The tranceiver eTRX of the patient device and of the implant iTRX are both adapted to operate in the MICS band, a wireless communication frequency band reserved for medical implant communications services.


A real world environment may comprise a plurality of patient devices and implants. Therefore, any patient device in such environment shall be assigned to its specific single implant or to no implant at all. Assigning a patient device to an implant is called pairing for the purpose of this description.


Patient device 10 may be in different states of pairing. Patient device 10 may be unpaired, can be soft paired or can be permanently paired (hard paired) to a specific implant. Soft pairing of a patient device to an implant results from automatic pairing, whereas hard pairing of a patient device to an implant results from manual pairing, e.g. via programmer 14.


When in its soft paired state, patient device 10 will return to its unpaired state if for a predetermined period of time no data communication has occurred with the implant that patient device 10 is paired to. For a hard paired patient device, no such period of time is applicable, thus a hard paired patient device is permanently paired to a specific implant.


When patient device 10 is in its unpaired state, patient device 10 also is in a search mode wherein patient device 10 carries out a protocol for automatic pairing. As long as patient device 10 is paired to its specific implant, patient device 10 may be either in a wait mode as long as no data communication is going on with the implant patient device 10 is assigned (paired) to, or in a communication mode during data communication between patient device 10 and the implant patient device 10 is paired to.


As long as patient device 10 is unpaired and therefore is in its search mode, control unit eCTRL causes the patient devices transceiver eTRX to periodically scan the MICS band in order to determine a least used channel. This is called “listen before talk”. Thereafter, patient device 10 will use the least used channel to send out a data packet containing the patient device's identification code EID and an unspecific implant identification code IID as is stored in memory eMEM. Since, when in its search mode patient device 10 is in its unpaired state, no or an unspecific implant identification code is stored in the memory eMEM. In the data packet, an origin identifier bit is set in order to mark the data packet as originating from a patient device.


An implant like implant 12 scanning all channels of the MICS bend eventually may receive a data packet originating from patient device 10. If the data packet contains a specific implant identification code IID that does not correspond to the receiving implant's implant identification code IID, then the receiving implant will not respond to such data packet. On the other hand, if the data packet received by the implant contains an unspecific implant identification code IID (e.g. IID=0), the implant will respond to the data packet by sending out a data packet containing the patient device identification code EID as received with the incoming data packet, its implant identification code IID and a origin identifier bit set as to mark a data packet originating from an implant.


If patient device 10 receives such data packet originating from an implant containing the patient device's own identification code EID, such data packet causes patient device 10 to enter its tentatively paired mode and to store the implant identification code IID received with the data package in memory eMEM.


Patient device 10 thereupon will send out a further data packet with its own identification code EID being the specific patient device identification code as stored in patient device's eROM and the origin identifier bit set to “patient device”. Thereafter, patient device 10 will wait for a predetermined first period of time for a response data packet from the specific implant patient device 10 is tentatively paired to. If during the predetermined period of time a response data packet is received from the implant the patient device is tentatively paired to, and the response data packet contains the patient device's own identification code, then patient device 10 will enter its soft paired state.


The patient device will stay in its soft paired state as long as a data communication periodically occurs with the implant to which the patient device is paired, and as long as no manual reset of the patient device to its unpaired state occurs.


If for another predetermined period of time, being longer than the first period of time that the patient device will wait until leaving its tentatively paired state no data communication between the patient device and the implant it is paired to occurs, the soft paired state is cancelled and the patient device returns into its unpaired state. This is controlled by timer and control unit eCTRL, and is performed by storing an unspecific implant identification code IID, e.g. IID=0, into memory eMEM of patient device 10.


At any time patient device 10 may be manually reset by pressing reset button RESET, or via other means, e.g., a physician, programmer or via the internet.


For further details of the patient device's behavior with respect to pairing please refer to the state diagram in FIG. 2 and the description above.


Although an exemplary embodiment of the present invention has been shown and described, it should be apparent to those of ordinary skill that a number of changes and modifications to the invention may be made without departing from the spirit and scope of the invention. This invention can readily be adapted to such devices by following the present teachings. All such changes, modifications and alterations should therefore be recognized as falling within the scope of the present invention.

Claims
  • 1. A patient device for wireless data communication with an implant comprising: a first receiver; a volatile memory operatively connected to said first receiver, said volatile memory being configured to store an implant identification code (IID);a non-volatile memory operatively connected to said first receiver, said non-volatile memory being configured to permanently store a patient device identification code (EID);a timer; and,a control unit operatively connected to said first receiver, said volatile and non-volatile memories and said timer;wherein said patient device can be at least in an unpaired state and in a paired state, wherein in said paired state said patent device is paired to an implant specified by said implant identification code that is stored in said volatile memory of said patient device, and wherein said control unit is adapted to automatically pair said patient device to said implant upon receiving an incoming data packet containing said implant identification code when said patient device is in said unpaired state with no valid implant identification code stored in said volatile memory prior to receiving said incoming data packet containing said implant identification code; and,said control unit being further adapted to either cancel pairing to said implant, if no further data communication occurs within a first predetermined period of time after first receiving said incoming data packet containing said implant identification code leading to tentative pairing, or,maintain a soft paired state to said implant by keeping said implant identification code in said volatile memory if further data communication occurs within a predetermined period of time after first receiving said incoming data packet containing said implant identification code leading to tentative pairing.
  • 2. The patient device according to claim 1, wherein said control unit is adapted to tentatively pair said patient device to said implant identified by said implant identification code contained in said incoming data packet by storing said implant identification code in said volatile memory and to cancel tentative pairing to said implant by deleting said implant identification code in said memory.
  • 3. The patient device according to claim 1, wherein said patient device comprises a second receiver for receiving programmer commands and wherein said control unit is adapted to permanently pair (hard pair) said patient device to said implant if said patient device receives a command via said second receiver containing said implant identification code and a hard-pair instruction.
  • 4. The patient device according to claim 1, wherein said control unit is adapted to cause said patient device's receiver to periodically or continuously scan or monitor a predetermined wireless communication frequency band or a predetermined channel within said wireless communication frequency band, respectively, for incoming data packets containing said implant identification code.
  • 5. The patient device according to claim 4, wherein said control unit is adapted to cause said patient device's receiver to periodically or continuously scan all channels of a predetermined wireless communication frequency band for incoming data packets containing said implant identification code when said patient device is in its unpaired state.
  • 6. The patient device according to claim 4, wherein said control unit is adapted to cause said patient device's receiver to periodically or continuously monitor a predetermined channel in said wireless communication frequency band for incoming data packets containing said implant identification code when in said paired mode, said channel being determined during pairing.
  • 7. The patient device according to claim 1, wherein said first receiver is part of a transceiver and wherein said control unit is adapted to cause said patient device's transceiver to: periodically or continuously scan a predetermined data transmission band for a least used channel;send out an outgoing data packet containing said patient device identification code using said least used channel; and,wait for an incoming data packet in response to said outgoing data packet containing said patient device identification code and said implant identification code.
  • 8. The patient device according to claim 1, wherein said control unit is adapted to discriminate data packets originating from said implant from data packets originating from other devices.
  • 9. The patient device according to claim 8, wherein said control unit is adapted to evaluate a predetermined bit of an incoming data packet in order to determine whether or not said data originates from said implant or not.
  • 10. The patient device according to claim 8, wherein said control unit is adapted to reject pairing when determination of said incoming data packets origin indicates that said incoming data packet does not originate from said implant.
  • 11. The patient device according to claim 1, wherein said control unit is adapted to reject pairing when said patient device receives an incoming data packet containing a specific patient device identification code other than said patient device's own patient device identification code.
  • 12. The patient device according to claim 11, wherein said control unit is adapted to allow for pairing when said patient device receives an incoming data packet containing an unspecific patient device identification code.
  • 13. The patient device according to claim 1, wherein said patient device comprises a user actionable means for setting said patient device in said unpaired state.
  • 14. The patient device according to claim 13, wherein said user actionable means is a reset button operatively connected to said control unit, said control unit being adapted to delete said implant identification code in said volatile memory in response to pressing said reset button.
  • 15. The patient device according to claim 1, wherein said control unit is adapted to reset said patient device from said soft paired state to said unpaired state if for a second predetermined period of time no further incoming data packet containing a stored implant identification code is received, said second period of time being longer than said first predetermined period of time.
  • 16. The patient device according to claim 1, wherein said control unit is adapted to set said patient device in its unpaired state.
  • 17. The patient device according to claim 1, wherein said control unit is adapted to respond differently to different incoming data packets, based on a priority indicator contained in said data packets.
  • 18. The patient device according to claim 17, wherein said control unit is adapted to accept and to forward each data packet containing a high priority indicator regardless whether or not said data packet contains said specific implant identification code that is stored in said patient device and regardless of a state of pairing of said patient device.
  • 19. The patient device according to claim 17, wherein if said patient device is in said soft paired state, then said control unit is adapted to accept and to respond to each data packet containing a medium priority indicator regardless of whether or not said data packet contains said specific implant identification code that is stored in said patient device.
  • 20. The patient device according to claim 17, wherein said control unit is adapted to accept and to respond to a data packet containing a low priority indicator only if said data packet contains said specific implant identification code corresponding to said implant identification code stored in said patient device.
  • 21. The patient device according to claim 1 being adapted to be paired to at least two implants at said same time, wherein said volatile memory is configured to store at least two implant identification codes.
  • 22. The patient device according to claim 1 wherein said data packet for use in wireless communication between said patient device and said implant comprises: said implant identification code;said patient device identification code; and,an identifier of data packet origin.
  • 23. The patient device according to claim 22 wherein said identifier of data packet origin is a single origin identifier bit which in its first state, 0 or 1, characterizes a data packet originating from an implant and in its second state, 1 or 0, respectively, characterizes a data packet originating from a patient device.
  • 24. The patient device according to claim 22, wherein said data packet further comprises a priority indicator, said priority indicator having at least thee different states, a first state thereof corresponding to a low priority, a second state thereof corresponding to a medium priority and a third state thereof corresponding to a high priority.