Implantable neurostimulator supporting trial and chronic modes

• US 10,046,164 B2
• Filed: 08/15/2013
• Issued: 08/14/2018
• Est. Priority Date: 02/23/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/968,290
• Publication Number:
  US 20130331909A1
• Time in Patent Office: 1,825 Days
• Field of Search: 607 59
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

In some examples, a chronic implantable neurostimulator supports trial and chronic modes of operation. In addition, in some examples, the neurostimulator can alternatively include one or more sensors that may or may not function differently in trial and chronic modes. The device may be designed to be used as both a trial neurostimulator and a permanent, or chronic, neurostimulator. A trial neurostimulation period can be used to evaluate the efficacy of the therapy. A percutaneous or implantable trial neurostimulator is used for the trial neurostimulation period. In most cases, the trial period is successful, in which case the trial stimulator is explanted and replaced with a permanent, i.e., “chronic,” implantable stimulator. In accordance with the disclosure, an implantable neurostimulator supports both trial neurostimulation and chronic neurostimulation in the event trial stimulation is successful.

Claims

1. A system comprising:

an electrical stimulator including;

a pulse generator configured to be coupled to an electrode; and

a processor configured to activate the pulse generator to deliver electrical stimulation for a first authorized use of the pulse generator, and to disable the pulse generator to stop the delivery of electrical stimulation after the first authorized use; and

an external computing device configured to transmit an authorization to the processor,

wherein upon being disabled, the pulse generator is prevented from being reactivated in response to patient input until the processor receives the authorization from the external computing device, and

wherein the processor is configured to reactivate the pulse generator to deliver electrical stimulation for a second authorized use of operation following the first authorized use in response to receiving the authorization.

2. The system of claim 1, wherein the processor is configured to activate the pulse generator to deliver electrical stimulation for the first authorized use by at least controlling the pulse generator to deliver electrical stimulation for a first predetermined period of operation, and wherein the processor is configured to reactivate the pulse generator to deliver electrical stimulation for the second authorized use by at least controlling the pulse generator to deliver electrical stimulation for a second predetermined period of operation.

3. The system of claim 1, wherein the computing device is configured to transmit a plurality of authorizations to the processor, wherein the processor is configured to receive the plurality of authorizations and, for each authorization of the plurality of authorizations, activate the pulse generator to deliver electrical stimulation for a respective authorized use corresponding to the authorization.

4. The system of claim 3, wherein the authorized uses are defined by respective predetermined periods of operation.

5. The system of claim 3, wherein the computing device is configured to provide the authorizations on a recurring basis for a recurring fee.

6. The system of claim 1, wherein the computing device is configured to provide the authorization for a fee.

7. The system of claim 1, wherein the processor is configured to disable the electrical stimulator after the first authorized use and until the authorization is received.

8. A system comprising:

means for delivering electrical stimulation;

means for activating the means for delivering electrical stimulation for a first authorized use of the means for delivering electrical stimulation;

means for disabling the means for delivering electrical stimulation to stop the delivery of electrical stimulation after the first authorized use; and

means for transmitting an authorization to the means for activating,

wherein upon being disabled after the first authorized use, the means for delivering electrical stimulation is prevented from being reactivated in response to patient input until the means for activating receives the authorization from the means for transmitting, and

wherein the means for activating reactivates the means for delivering electrical stimulation for a second authorized use of the means for delivering electrical stimulation when the authorization is received.

9. The system of claim 8, wherein the first authorized use corresponds to an authorized period of operation of the means for delivering electrical stimulation, the system further comprising:

means for determining an expiration of the authorized period of operation, wherein the means for disabling the means for delivering electrical stimulation disables the means for delivering electrical stimulation in response to the expiration of the authorized period of authorization.

10. The system of claim 9, wherein the means for disabling comprises means for controlling the means for delivering electrical stimulation to stop delivering electrical stimulation.

11. The system of claim 8, wherein the authorization comprises a first authorization, the system further comprising:

means for receiving a plurality of additional authorizations; and

means for activating, for each authorization of the plurality of additional authorizations, the means for delivering electrical stimulation to deliver electrical stimulation for a respective additional authorized use corresponding to the authorization.

12. The system of claim 11, wherein the authorized uses are defined by respective predetermined periods of operation.

13. The system of claim 8, further comprising means for disabling the means for delivering electrical stimulation after the first authorized use and until the authorization is received.

14. The system of claim 8, wherein the means for activating comprises means for controlling the means for delivering electrical stimulation to deliver electrical stimulation for a first predetermined period of operation for the first authorized use, and means for controlling the means for delivering electrical stimulation to deliver electrical stimulation for a second predetermined period of operation for the second authorized use.

15. The system of claim 8, wherein the means for transmitting comprises means for transmitting the authorization in response to payment of a fee.

16. The system of claim 15, wherein the means for transmitting comprises means for transmitting additional authorizations for the means for delivering electrical stimulation to deliver electrical stimulation for additional authorized uses in response to payments of additional fees.

17. A medical device system comprising:

an electrical stimulator comprising a pulse generator configured to generate electrical stimulation, and at least one electrode configured to deliver the electrical stimulation to a patient; and

a processor configured to activate the pulse generator to generate electrical stimulation during a first authorized use of the pulse generator, disable the pulse generator after the first authorized use, receive, after disabling the pulse generator after the first authorized use, an authorization from an external computing device, and reactivate the pulse generator to deliver electrical stimulation for a second authorized use when the authorization is received,

wherein upon being disabled, the pulse generator is prevented from being reactivated in response to patient input until the processor receives the authorization from the external computing device.

18. The system of claim 17, wherein the first authorized use corresponds to an authorized period of operation, wherein the processor is configured to disable the pulse generator upon expiration of the authorized period of operation.

19. The system of claim 17, wherein, to disable the pulse generator, the processor is configured to control the pulse generator to stop generating electrical stimulation.

20. The system of claim 17, wherein the authorization comprises a first authorization, and the processor is further configured to receive a plurality of additional authorizations from the computing device, and, for each authorization of the plurality of additional authorizations, activate the pulse generator for a respective additional authorized use corresponding to the authorization.

21. The system of claim 20, wherein the authorized uses are defined by respective predetermined periods of operation.

22. The system of claim 17, wherein the processor is configured to disable the pulse generator after the first authorized use and until the authorization is received from the external computing device.

23. The system of claim 17, wherein the processor is configured to control the pulse generator to deliver electrical stimulation for a first predetermined period of operation for the first authorized use, and control the pulse generator to deliver electrical stimulation for a second predetermined period of operation for the second authorized use.

24. The system of claim 17, further comprising the external computing device configured to transmit the authorization to the processor in response to payment of a fee.

25. The system of claim 24, wherein the computing device is configured to transmit additional authorizations to the processor for additional authorized uses in response to payments of additional fees.

26. A system comprising:

a pulse generator configured to generate electrical stimulation therapy; and

a processor configured to activate the pulse generator to deliver electrical stimulation during a first authorized use of the pulse generator, and to disable the pulse generator to stop the delivery of electrical stimulation after the first authorized use until an authorization from an external computing device is received,

wherein the processor is configured to, after disabling the pulse generator after the first authorized use, receive the authorization from the external computing device, and reactivate the pulse generator to deliver electrical stimulation during a second authorized use following the first authorized use in response to receiving the authorization,

wherein the authorization authorizes use of a different mode of operation than the first authorized use, and wherein the pulse generator is configured to generate electrical stimulation according to the different mode of operating during the second authorized use.

27. The system of claim 26, wherein the processor is configured to control the pulse generator to generate electrical stimulation according to the different mode of operating during the second authorized use by at least controlling the pulse generator to generate electrical stimulation according to a set of electrical stimulation parameter values that is different than any set of electrical stimulation parameter values used by the pulse generator during the first authorized use.

28. The system of claim 26, further comprising the external computing device.

29. A nerve stimulation system comprising:

a neurostimulator unit including;

a pulse generator configured to couple to an electrode configured to be inserted adjacent a stimulation site of a patient; and

a processor in communication with the pulse generator and configured to activate the pulse generator to generate electrical stimulation during an authorized use of the pulse generator, and to disable the pulse generator to stop the delivery of electrical stimulation after the authorized use; and

an external computing device operable to communicate with the processor of the neurostimulator unit to transmit an authorization to the processor, wherein upon being disabled, the pulse generator is prevented from being reactivated in response to patient input until the processor receives the authorization from the external computing device, and wherein the processor is configured to reactivate the pulse generator to generate electrical stimulation during another authorized use of the pulse generator when the authorization is received.

30. The system of claim 29, wherein the authorized use corresponds to an authorized period of operation of the pulse generator, the system further comprising a timer, the timer being configured to time the authorized period of operation, wherein the processor is configured to disable the pulse generator in response to expiration of the timer.

31. The system of claim 30, wherein the processor is configured to disable the pulse generator by at least controlling the pulse generator to stop generating electrical stimulation.

32. The system of claim 29, wherein the authorized use is defined by a predetermined period of operation.

33. The system of claim 29, wherein the computing device is configured to transmit a plurality of authorizations to the processor, wherein the processor is configured to receive the plurality of authorizations and, for each authorization of the plurality of authorizations, activate the pulse generator for a respective authorized use corresponding to the authorization.

34. The system of claim 33, wherein the authorized uses are defined by respective predetermined periods of operation.

35. The system of claim 33, wherein the computing device is configured to provide the authorizations on a recurring basis for a recurring fee.

36. The system of claim 29, wherein the processor is configured to disable the pulse generator after the authorized use and until the authorization is received.

37. A method comprising:

transmitting, by an external computing device, a first authorization to a processor of a neurostimulator unit, wherein the processor is configured to receive the first authorization from the external computing device to activate a pulse generator of the neurostimulator unit for a first authorized use of the pulse generator when the first authorization is received, and to disable the pulse generator to stop the delivery of electrical stimulation after the first authorized use, wherein upon being disabled, the pulse generator is prevented from being reactivated in response to patient input until the processor receives a second authorization from the external computing device; and

transmitting, by the external computing device, the second authorization to the processor of the neurostimulator unit, wherein the processor is configured to, after disabling the pulse generator after the first authorized use, receive the second authorization from the computing device and to reactivate the pulse generator of the neurostimulator unit to generate electrical stimulation for a second authorized use of the pulse generator when the second authorization is received.

38. The method of claim 37, wherein transmitting the second authorization comprises transmitting the second authorization in response to receiving a fee.

39. The method of claim 37, further comprising transmitting additional authorizations for the pulse generator of the neurostimulator unit to generate electrical stimulation for additional authorized uses in response to payments of additional fees.

40. A method comprising:

activating, by a processor, a pulse generator to generate electrical stimulation for a first authorized use of the pulse generator;

disabling, by the processor, the pulse generator to stop the delivery of electrical stimulation after the first authorized use, wherein upon being disabled, the pulse generator is prevented from being reactivated in response to patient input until the processor receives an authorization from an external computing device;

after disabling the pulse generator after the first authorized use, receiving, by the processor, the authorization from the external computing device; and

reactivating, by the processor, the pulse generator to generate electrical stimulation for a second authorized use of the pulse generator when the authorization is received.

41. The method of claim 40, wherein the first authorized use corresponds to an authorized period of operation of the pulse generator, the method further comprising:

timing, by a timer, the authorized period of operation; and

disabling, by the processor, the pulse generator in response to expiration of the timer.

42. The method of claim 41, wherein disabling the pulse generator in response to expiration of the timer comprises controlling the pulse generator to stop generating electrical stimulation.

43. The method of claim 40, wherein the authorization comprises a first authorization, the method further comprising:

receiving, by the processor, a plurality of additional authorizations from the computing device; and

for each authorization of the plurality of authorizations, activating, by the processor, the pulse generator for a respective additional authorized use corresponding to the authorization.

44. The method of claim 43, wherein the authorized uses are defined by respective predetermined periods of operation.

45. The method of claim 40, further comprising disabling the pulse generator after the first authorized use and until the authorization is received.

46. The method of claim 40, wherein activating the pulse generator to generate electrical stimulation for the first authorized use comprises controlling the pulse generator to generate electrical stimulation for a first predetermined period of operation, and wherein reactivating the pulse generator to generate electrical stimulation for the second authorized use comprises controlling the pulse generator to generate electrical stimulation for a second predetermined period of operation.

47. The method of claim 40, further comprising receiving the authorization in response to payment of a fee.

48. The method of claim 40, further comprising receiving additional authorizations for the pulse generator to generate electrical stimulation for additional authorized uses in response to payments of additional fees.