Patient programmer for implantable devices

• US 20030114899A1
• Filed: 01/31/2003
• Published: 06/19/2003
• Est. Priority Date: 07/27/1999
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Woods, Carla Mann, Thacker, James R., Peterson, David K.L.
• Granted Patent: US 7,177,690 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

The invention is a system and method for detecting the status of a rechargeable battery included within an implantable medical device. The medical device can incorporate a status indicator which signals the user concerning the battery status, e.g., low battery level. The signal may be audible or it may arise from an electrical stimulation that is perceptually distinguished from the operative, therapeutic stimulation. The external programmer may also incorporate a second battery status indicator that is visual, audible, or physically felt. Battery status data may be conveyed on visual displays on the external programmer by uploading this information from the medical device using a bi-directional telemetry link. Such battery status data are helpful to the user to indicate when the battery should be recharged and to the clinician to monitor patient compliance and to determine end-of-useful life of the rechargeable battery.

Claims

1. An implantable medical device system having a replenishable power source comprising:

an implantable medical device, the device having a housing which contains processing circuitry; and

an external programmer that may be placed in telecommunicative contact with the implantable medical device,

wherein the external programmer includes a status indicator for indicating the status of the replenishable power source within the implantable medical device.

2. The system of claim 1, wherein the replenishable power source is a rechargeable battery.

3. The system of claim 2, wherein the status indicator provides an indication of battery status, including the level of battery charge.

4. The system of claim 3, further comprising:

means for recording battery charging information, which may be recalled later.

5. The system of claim 4, wherein the means for recording charging information is a memory storage contained within the implantable device, which can record battery status data, including time of charge, duration of charge, rate of charge, and level of charge, and which battery status data can be recalled from the memory storage by the external programmer using RF communication.

6. The system of claim 4, wherein the battery charging information can only be recalled by a clinician program in the handheld device.

7. The system of claim 6, wherein the clinician program in the external programmer is enabled through a password or key code system.

8. The system of claim 2, wherein the rechargeable battery is a lithium-ion battery.

9. The system of claim 1, wherein the status indicator is selected from the group consisting of an audible signal emanating from the external programmer and a visual signal on the external programmer.

10. The system of claim 1, wherein the external programmer is a portable, hand held programmer (HHP);

and

wherein the status indicator is a vibration of the HHP.

11. The system of claim 1,

wherein the medical device is an implantable pulse generator (IPG) connected to an electrode array;

and

wherein the IPG includes a second status indicator which is an electrical signal delivered through the electrode array, which electrical signal can be perceived and distinguished from normal, therapeutic stimulation.

12. The system of claim 11, wherein the second status indicator is the electrical signal applied to cochlear nerves that is perceived as a distinguishable sound.

13. The system of claim 12, wherein the sound is selected from the groups consisting of tones, pattern of sounds, music and speech.

14. The system of claim 11, wherein the second status indicator is the electrical signal applied to spinal cord nerves that is felt as a distinguishable perception.

15. The system of claim 1, further comprising:

means for non-invasively recharging the replenishable power source through the skin.

16. The system of claim 15, wherein the means for non-invasively recharging the replenishable power source is transcutaneous, RF power transmissions using a primary, implanted coil connected to the IPG and a secondary, external coil connected to an external recharger, wherein the primary and secondary coils are placed over each other to effect RF power transmission.

17. An implantable medical device system, having a rechargeable battery comprising:

an implantable medical device having a housing which contains processing circuitry and memory; and

an external programmer that may be placed in telecommunicative contact with the medical device,

wherein the medical device includes a status indicator for indicating the status of the rechargeable battery contained in the medical device.

18. The system of claim 17, wherein the status indicator is a distinguishable, audible sound emanating from the medical device.

19. The system of claim 18, wherein the sound is selected from the group consisting of tones, pattern of sounds, music and speech.

20. The system of claim 17,

wherein the medical device is an implantable pulse generator (IPG) connected to an electrode array;

and

wherein the IPG has a status indicator that is an electrical signal delivered through the electrode array which can be perceived and distinguished from normal, operative stimulation used for therapy.

21. The system of claim 20, wherein the electrical signals are delivered directly to cochlear nerves and perceived as distinguishable sounds.

22. The system of claim 21, wherein the sounds perceived are selected from the group consisting of tones, pattern of sounds, music and speech.

23. The system of claim 20, wherein the electrical signals are delivered to the spinal cord nerves and felt as a distinguishable sensation.

24. A method for detecting and indicating the status of the rechargeable battery contained within an implanted medical device, the device having a memory storage for storing battery status data, the method comprising:

(a) implanting the medical device;

(b) interrogating the medical device with an external programmer to upload battery status data stored in memory storage; and

(c) indicating the battery status with a status indicator included on the external programmer.

25. The method of claim 24, wherein the rechargeable battery is a lithium-ion battery.

26. The method of claim 24, wherein the status indicator is selected from the group consisting of an audible signal emanating from the external programmer and a visual signal on the external programmer.

27. The method of claim 26, wherein the external programmer is a hand held programmer (HHP);

and

wherein the status indicator is vibration emanating from the HHP.

28. The method of claim 24, wherein the status indicator is a visual signal from a display indicating battery status data, which may include the last time the battery was charged, duration of the last charge and number of times charging has been performed.

29. The method of claim 28, wherein the battery status data can only be recalled by a clinician program in the external programmer.

30. The method of claim 29, wherein the clinician program in the programmer is enabled through a password or key code system, which permits access to the clinician program.

31. The method of claim 24, further comprising:

(d) indicating the battery status data with a second status indicator included in the implantable medical device.

32. The method of claim 31, wherein the second status indicator is an audible sound emanating from the medical device that can act as a signal to indicate battery status.

33. The method of claim 31, wherein the medical device is an implantable pulse generator (IPG) connected to an electrode array;

wherein the second status indicator is an electrical signal delivered through the electrode array to produce a signal perceived by a user in which the IPG is implanted; and

wherein the perceived electrical signal is distinguishable from the normal, operative perception produced by therapeutic stimulation.

34. The method of claim 33, wherein the second status indicator is an electrical signal delivered to the cochlea that is perceived as a distinguishable sound.

35. The method of claim 33, wherein the second status indicator is an electrical signal delivered to the spinal cord that is felt as a distinguishable perception.

36. A method for detecting and indicating the status of the rechargeable battery contained within an implantable medical device that has a memory storage for storing battery status data, the method comprising:

(a) implanting the medical device; and

(b) indicating the battery status data with a status indicator included in the medical device.

37. The method of claim 36, wherein the rechargeable battery is a lithium-ion battery.

38. The method of claim 36, wherein the status indicator is selected from the group consisting of an audible signal emanating from the medical device and vibration of the medical device.

39. The method of claim 38, wherein the status indicator indicates low battery charge level, signaling the need to recharge the battery.

40. The method of claim 36,

wherein the implantable medical device is an implantable pulse generator (IPG) connected to an electrode array;

wherein the status indicator is an electrical signal delivered through the electrode array to produce a signal perceived by a user in which the IPG is implanted; and

wherein the perceived signal is distinguishable from the normal, operative perception produced by therapeutic stimulation.

41. The method of claim 40, wherein the perceived signal is a distinguishable, sound produced by delivering the electrical signal directly to the user'"'"'s cochlea.

42. The method of claim 41, wherein the sound is selected from the group consisting of tones, pattern of sounds, music and speech.

43. The method of claim 40, wherein the perceived signal is a distinguishable, felt perception produced by delivering the electrical signal to the user'"'"'s spinal cord nerves.