System and method for temporary programming for implanted medical devices

• US 7,460,912 B2
• Filed: 11/19/2004
• Issued: 12/02/2008
• Est. Priority Date: 11/19/2004
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation), Guidant Corporation (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hoyme, Kenneth P., Quiles, Sylvia, Ternes, David, Simms, Howard D. Jr., Sowder, Conrad L., Smythe, Alan H.
• Primary Examiner(s): Getzow; Scott M.
• Application Number:
  US10/993,699
• Publication Number:
  US 20060111759A1
• Time in Patent Office: 1,474 Days
• Field of Search: 607 28- 30, 607/59
• US Class Current: 607/59
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• 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 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A system and method for temporary programming of an implantable medical device. The system and method include a repeater uploading temporary programming and instructions to a temporary memory of the device and then instructing the device to operate according to the temporary instructions. If during a first time period, the device is not in continuous periodic communication with the repeater, the device automatically reverts to operation under the normal operating instructions. At the end of the first time period, the caregiver or the patient may decide to revert to the normal programming. During a second time period, the device operates according to the temporary programming unless the caregiver or the patient instructs the device to revert to the normal programming, or the device fails to receive a periodic continuation signal from the repeater. Adverse health affects to the patient may also trigger the device to revert to the normal programming during either the first or second time period.

Claims

1. A system for programming an implanted medical device comprising:

a medical device configured to be implanted within in a body of a patient;

the medical device including electrical circuitry to provide treatment to the patient, a first digital storage area for holding normal operation instructions and settings, a second digital storage area for holding temporary operating instructions and settings, a communications subsystem and a timing subsystem;

a repeater external of the patient'"'"'s body, the repeater including a communication subsystem configured to communicate with the communications subsystem of the medical device and with a programming device;

the patient, the medical device and the repeater remotely located from the programming device;

the medical device configured to provide therapy to the patient using the normal operation instructions and settings stored in the first digital storage area;

the repeater configured to transmit temporary operation instructions and settings to the medical device for storage in the second digital storage area;

the repeater configured to instruct the medical device to use the temporary operating instructions and settings to deliver therapy to the patient;

wherein upon receiving from the repeater the instruction to use the temporary operating instructions and settings to deliver therapy to the patient, the medical device initiates a first predetermined period of time during which the medical device begins delivering therapy using the temporary operation instructions and settings, and wherein the medical device will revert to the normal operation instructions and settings if the medical device fails to receive a continuation signal from the repeater within a first time interval during the first predetermined period of time; and

wherein upon completion of the first predetermined period of time without reverting to normal operation, the medical device initiates a second predetermined period of time during which the medical device is configured to revert to the normal operation instructions and settings if the medical device fails to receive a continuation signal from the repeater within a second time interval during the second predetermined period of time, wherein the second time interval is longer than the first time interval.

2. The system of claim 1, wherein the periodic continuation signal received from the repeater during a second predetermined period of time includes a request to transfer device function information from the medical device.

3. The system of claim 2, wherein the patient is ambulatory during the second predetermined period of time.

4. The system of claim 1, wherein the device is configured to replace the normal operation instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions after the second predetermined period of time.

5. The system of claim 1, wherein the device is configured to revert to delivery of therapy to the patient based on the normal operation instructions after the second predetermined period of time, unless instructed to replace the normal operation instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions.

6. The system of claim 1, wherein the repeater is configured to signal the device to replace the normal instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions.

7. The system of claim 1, wherein the repeater is configured to signal to the device to revert to delivery of therapy to the patient based on the normal operation instructions, and remove the temporary operation instructions from the second digital storage area.

8. The system of claim 1, wherein the device is configured to sense patient response to the therapy based on the temporary operation instructions and revert to delivering therapy based on the normal operation instructions if the device senses an adverse response to the therapy based on the temporary operation instructions.

9. The system of claim 1, wherein the device is configured to sense patient response to the therapy based on the temporary operation instructions and, if the response is acceptable, to replace the normal instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions.

10. The system of claim 1, wherein the repeater is configured to receive data from the device regarding patient response to therapy delivered based on the temporary operation instructions and communicating to the device to revert to delivering therapy based on the normal operation instructions if the patient response to therapy based on the temporary operation instructions is adverse.

11. The system of claim 1, wherein the repeater is configured to receive data from the device regarding patient response to therapy delivered based on the temporary operation instructions and, if the response is acceptable, to signal the device to replace the normal instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions.

12. The system of claim 1, wherein the device is configured to respond to the patient signaling the device by reverting to delivering therapy based on the normal operation instructions if the temporary operation instructions do not provide acceptable patient response.

13. The system of claim 12, wherein the patient signals the device to revert to delivering therapy based on the normal operation instructions using a magnet.

14. The system of claim 12, wherein the patient signals the device to revert to delivering therapy based on the normal operation instructions using an electronic wand.

15. The system of claim 1, wherein the device is configured to respond to the patient signaling the device by replacing the normal operation instructions with the temporary operation instructions and normally delivering therapy to the patient based on the formerly temporary operation instructions.

16. The system of claim 15, wherein the patient signals the device to replace the normal instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions using a magnet.

17. The system of claim 15, wherein the patient signals the device to replace the normal instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions using an electronic wand.

18. The system of claim 1, wherein the device is configured to respond to the caregiver signaling the device by reverting to delivering therapy based on the normal operation instructions if the temporary operation instructions do not provide acceptable patient response.

19. The system of claim 18, wherein the caregiver signals the device to revert to delivering therapy based on the normal operation instructions using a magnet.

20. The system of claim 18, wherein the caregiver signals the device to revert to delivering therapy based on the normal operation instructions using an electronic wand.

21. A method of providing therapy to a patient with a programmable implantable medical device, the method comprising:

providing the programmable implantable medical device and an external repeater remotely located from a caregiver facility, the device delivering therapy to the patient based on normal operating instructions stored in a first memory of the device, the repeater to communicate with a programming device;

the programming device at the caregiver facility communicating temporary operating instructions to the repeater;

the repeater communicating the temporary operating instructions to the device, and the device storing the temporary operating instructions in a second memory;

the repeater communicating with the device to begin delivering therapy to the patient based on the temporary operating instructions during a first predetermined period of time initiated by the device upon receiving from the repeater an instruction to use the temporary operating instructions and settings to deliver therapy to the patient;

the device reverting to delivering therapy to the patient based on the normal operating instructions if the device does not receive a continuation signal from the repeater within a first time interval during the first predetermined period of time;

the device initiating a second predetermined upon completion of the first predetermined period of time without reverting to normal operation; and

the device reverting to delivery of therapy to the patient based on the normal operation instructions if the device fails to receive a continuation signal from the repeater within a second time interval during the second predetermined period of time following the first predetermined period of time, wherein the second time interval is longer than the first time interval.

22. The method of claim 21, wherein the device reverting during the second predetermined time period includes the device reverting to delivering therapy to the patient based on the normal operating instructions if the device does not receive a request to transfer device function information from the medical device to the repeater within a second predetermined period of time.

23. The method of claim 22, wherein the patient is ambulatory during the second predetermined period of time.

24. The method of claim 21, further comprising the device replacing the normal operating instructions with the temporary operating instructions and normally delivering therapy to the patient based on the formerly temporary operating instructions after the second predetermined period of time.

25. The method of claim 21, further comprising the device is not instructed to replace the normal operation instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions, and the device reverting to delivery of therapy to the patient based on the normal operation instructions after the second predetermined period of time.

26. The method of claim 21, further comprising the repeater signaling the device to replace the normal instructions with the temporary instructions and normally provide therapy to the patient based on the formerly temporary instructions.

27. The method of claim 21, further comprising the repeater signaling the device to revert to delivery of therapy to the patient based on the normal operation instructions, and remove the temporary operation instructions from the second digital storage area.

28. The method of claim 21, further comprising the device sensing patient response to the therapy based on the temporary instructions and reverting to delivering therapy based on the normal instructions if the device senses an adverse response to the therapy based on the temporary instructions.

29. The method of claim 21, further comprising the device sensing patient response to the therapy based on the temporary operation instructions and, if the response is acceptable, replacing the normal instructions with the temporary operation instructions and delivering therapy to the patient based on the formerly temporary operation instructions.

30. The method of claim 21, further comprising the repeater receiving data from the device regarding patient response to therapy delivered based on the temporary instructions and communicating to the device to revert to delivering therapy based on the normal instructions if the patient response to therapy based on the temporary instructions is adverse.

31. The method of claim 21, further comprising the repeater receiving data from the device regarding patient response to therapy delivered based on the temporary operation instructions and, if the response is acceptable, signaling the device to replace the normal instructions with the temporary operation instructions and deliver therapy to the patient based on the formerly temporary operation instructions.

32. The method of claim 21, further comprising the patient signaling the device to revert to delivering therapy based on the normal operation instructions if the temporary operation instructions do not provide acceptable patient response.

33. The method of claim 32, wherein the patient signals the device using a magnet.

34. The method of claim 32, wherein the patient signals the patient with an electronic wand.

35. The method of claim 21, further comprising the device responding to a signal from the patient by replacing the normal operation instructions with the temporary operation instructions and delivering therapy to the patient based on the formerly temporary operation instructions.

36. The method of claim 35, further comprising the patient signaling the device to replace the normal instructions with the temporary operation instructions and deliver therapy to the patient based on the formerly temporary operation instructions using a magnet.

37. The method of claim 35, further comprising the patient signaling the device to replace the normal instructions with the temporary operation instructions and deliver therapy to the patient based on the formerly temporary operation instructions using an electronic wand.

38. The method of claim 21, further comprising the device responding to a signal from the caregiver by reverting to delivering therapy based on the normal operation instructions if the temporary operation instructions do not provide acceptable patient response.

39. The method of claim 38, wherein the caregiver signals the device to revert to delivering therapy based on the normal operation instructions using a magnet.

40. The method of claim 38, wherein the caregiver signals the device to revert to delivering therapy based on the normal operation instructions using an electronic wand.

41. The method of claim 32, further comprising the patient instructing the repeater to signal the device to revert to delivering therapy based on the normal instructions if the temporary instructions do not provide acceptable patient response.

42. A system for programming an implanted medical device comprising:

a medical device to be implanted within in a body of a patient, the medical device including electrical circuitry to provide treatment to the patient, a first digital storage area for holding normal operation instructions and settings, a second digital storage area for holding temporary operating instructions and settings, a communications subsystem and a timing subsystem;

a repeater for use external of the patient'"'"'s body, the repeater including a communication subsystem configured to communicate with the communications subsystem of the medical device and with a programming device;

the implanted medical device configured to provide therapy to the patient using the normal operation instructions and settings stored in the first digital storage area;

the repeater configured to transmit temporary operation instructions and settings to the medical device for storage in the second digital storage area;

the repeater configured to instruct the medical device to use the temporary operating instructions and settings to deliver therapy to the patient;

wherein upon receiving from the repeater the instruction to use the temporary operating instructions and settings to deliver therapy to the patient, the medical device initiates a first predetermined period of time during which the medical device begins delivering therapy using the temporary operation instructions and settings, and wherein the medical device is configured to revert to delivering therapy using the normal operation instructions and settings if the medical device fails to receive a continuation signal from the repeater within a first time interval during the first predetermined period of time; and

wherein after the first predetermined period of time completes without reverting to normal operation, the medical device initiates a second predetermined period of time during which the patient is ambulatory and the medical device is configured to revert back delivering therapy using the normal operation instructions and settings if the medical device fails to receive a continuation signal from the repeater within a second time interval during the second predetermined period of time, wherein the second time interval is longer than the first time interval.

43. The system of claim 42, wherein the device is configured to replace the normal operation instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions after the second predetermined period of time.

44. The system of claim 42, wherein the repeater is configured to signal the device to replace the normal instructions with the temporary operation instructions and normally deliver therapy to the patient based on the formerly temporary operation instructions.

45. The system of claim 42, wherein the device is configured to sense patient response to the therapy based on the temporary operation instructions and revert to delivering therapy based on the normal operation instructions if the device senses an adverse response to the therapy based on the temporary operation instructions.

46. The system of claim 42, wherein the repeater is configured to receive data from the device regarding patient response to therapy delivered based on the temporary operation instructions and communicating to the device to revert to delivering therapy based on the normal operation instructions if the patient response to therapy based on the temporary operation instructions is adverse.

47. The system of claim 42, wherein the device is configured to respond to the patient signaling the device by reverting to delivering therapy based on the normal operation instructions if the temporary operation instructions do not provide acceptable patient response.

48. The system of claim 47, wherein the patient signals the device to revert to delivering therapy based on the normal operation instructions using a magnet.

49. The system of claim 47, wherein the patient signals the device to revert to delivering therapy based on the normal operation instructions using an electronic wand.

50. A method of providing therapy to a patient wit a programmable implantable medical device, the method comprising:

providing the programmable implantable medical device and an external repeater;

delivering therapy with the device to the patient based on normal operating instructions stored in a first memory of the device;

communicating temporary operating instructions to the repeater;

communicating the temporary operating instructions to the device with the repeater;

storing the temporary operating instructions in a second memory of the device;

communicating to the device wit the repeater, instructing the device to begin delivering therapy to the patient based on the temporary operating instructions during a first predetermined period of time initiated by the device upon receiving from the repeater an instruction to use the temporary operating instructions and settings to deliver therapy to the patient;

reverting the device to delivering therapy to the patient based on the normal operating instructions if the device does not receive a continuation signal from the repeater within a first time interval during the first predetermined period of time;

while the patient is ambulatory, delivering therapy to the patient with the device based on the temporary operating instructions during a second predetermined period of time when the device receives a continuation signal from the repeater;

while the patient is ambulatory during the second predetermined period of time, reverting the device to delivering therapy to the patient based on the normal operating instructions if the device does not receive the continuation signal from the repeater within a second time interval during the second predetermined period of time, wherein the second time interval is longer than the first time interval.

51. The method of claim 50, further comprising the device replacing the normal operating instructions with the temporary operating instructions and normally delivering therapy to the patient based on the formerly temporary operating instructions after the second predetermined period of time.

52. The method of claim 50, further comprising the repeater signaling the device to replace the normal instructions with the temporary instructions and normally provide therapy to the patient based on the formerly temporary instructions.

53. The method of claim 50, further comprising the device sensing patient response to the therapy based on the temporary instructions and reverting to delivering therapy based on the normal instructions if the device senses an adverse response to the therapy based on the temporary instructions.

54. The method of claim 50, further comprising the repeater receiving data from the device regarding patient response to therapy delivered based on the temporary instructions and communicating to the device to revert to delivering therapy based on the normal instructions if the patient response to therapy based on the temporary instructions is adverse.

55. The method of claim 50, further comprising the patient signaling the device to revert to delivering therapy based on the normal instructions if the temporary instructions do not provide acceptable patient response.

56. The method of claim 55, wherein the patient signals the device using a magnet.

57. The method of claim 55, wherein the patient signals the patient with an electronic wand.