Controlling stimulation parameters of implanted tissue stimulators

• US 7,801,602 B2
• Filed: 03/24/2006
• Issued: 09/21/2010
• Est. Priority Date: 04/08/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Carbunaru, Rafael, McClure, Kelly H., Vamos, George
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/388,836
• Publication Number:
  US 20060229688A1
• Time in Patent Office: 1,642 Days
• Field of Search: 600/544, 600/510, 607/3, 607/9, 607/41, 607/197, 607/46, 607/2, 607/118, 607/378, 607/45, 607/34, 607/44, 607/72, 607/60
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Systems and techniques for controlling the stimulation of tissue. In one aspect, an apparatus includes an implantable stimulation device to elicit a response in a tissue by delivering one or more stimuli. The stimulation device includes a stimulus delivery element to deliver the one or more stimuli to elicit the response, a memory to store a range value identifying a range of values of a stimulation parameter relative to a first value, and a controller to control delivery of the stimuli by the stimulus delivery element in accordance with the range value. The stimulation parameter characterizes the stimuli to be delivered by the stimulation device.

Claims

1. An apparatus comprising:

an implantable stimulation device to elicit a response in a tissue by delivering one or more stimuli, the stimulation device including

a stimulus delivery element to deliver the one or more stimuli to elicit the response;

a memory to store a range value identifying a range of values of a stimulation parameter relative to a first value; and

a controller to control delivery of the one or more stimuli by the stimulus delivery element in accordance with the range value,

the stimulation parameter characterizing the one or more stimuli to be delivered by the stimulation device; and

a user interface configured to receive a proposed change to the stored range value.

2. The apparatus of claim 1, wherein the first value comprises a default value of the stimulation parameter.

3. The apparatus of claim 1, wherein the range value identifies the range of values by identifying a range of excluded values of the stimulation parameter.

4. The apparatus of claim 1, wherein the range of values comprises a range of allowable values of the stimulation parameter.

5. The apparatus of claim 1, wherein the range of values comprises a group of discrete allowable values of the stimulation parameter.

6. The apparatus of claim 1, wherein the first value comprises a midpoint of the range identified by the range value.

7. The apparatus of claim 1, wherein the first value comprises a boundary of the range identified by the range value.

8. The apparatus of claim 1, wherein the stimulation parameter characterizes an electrical signal delivered to stimulate the tissue.

9. The apparatus of claim 8, wherein the stimulation parameter characterizes one or more of a primary pulse amplitude, a primary pulse duration, a delay between a primary pulse and a secondary pulse, a secondary pulse amplitude, a secondary pulse duration, a period, a primary pulse shape, and a secondary pulse shape.

10. The apparatus of claim 1, wherein the stimulation parameter characterizes a bolus of chemical delivered to stimulate the tissue.

11. The apparatus of claim 1, wherein the stimulus delivery element comprises an electrode to deliver electrical stimuli to elicit the response.

12. The apparatus of claim 1, wherein the stimulus delivery element comprises a drug delivery device to deliver a chemical stimulus to elicit the response.

13. The apparatus of claim 1, wherein the controller comprises a data processing device to control the delivery of the one or more stimuli in accordance with logic of a set of machine-readable instructions.

14. The apparatus of claim 1, further comprising a data receiver to receive data from an extracorporeal portion, the received data including the range value stored at the memory.

15. An apparatus comprising:

an implantable stimulation device configured to deliver one or more stimuli to elicit a response from a tissue, the stimulation device including

a stimulus delivery element configured to deliver the one or more stimuli to elicit the response;

a transceiver configured to exchange data with an extracorporeal device;

a controller configured to control delivery of the one or more stimuli by the stimulus delivery element in light of the data exchanged with the extracorporeal device; and

a hardware limiter configured to limit the range of a characteristic of the one or more stimuli to be delivered by the stimulus delivery element independently of the controller.

16. The apparatus of claim 15, wherein the hardware limiter comprises a voltage limiter to limit a primary pulse voltage amplitude.

17. The apparatus of claim 15, wherein the hardware limiter comprises a current limiter configured to limit a primary pulse current amplitude.

18. The apparatus of claim 15, wherein the hardware limiter comprises a charge limiter configured to limit a charge delivered during a primary pulse.

19. The apparatus of claim 15, wherein the hardware limiter comprises a power limiter configured to limit a power delivered during a primary pulse.

20. The apparatus of claim 15, wherein the hardware limiter comprises a dosage limiter configured to limit a dosage of a chemical delivered to stimulate a tissue.

21. The apparatus of claim 20, wherein the dosage limiter comprises:

a flowmeter to measure the dosage delivered and generate a shut-off signal; and

a valve to receive the shut-off signal and stop the delivery of the chemical.

22. A system for stimulating tissue, comprising:

an implanted portion including

a stimulator configured to elicit a response from tissue using a stimulus, and

a data transmitter configured to transmit, over a data link, data regarding whether the stimulator is active; and

an extracorporeal portion including

a data receiver configured to receive the data from the implanted portion over the data link,

a user interface configured to receive a proposed change to the stimulus from a user,

a processor configured to hinder the change to the stimulus when the data receiver receives data indicating that the stimulator is not currently active, and

a logic circuit to determine if the proposed change to the stimulus received from the user would increase the stimulation,

wherein the processor is configured to reject the change to the stimulus when the data receiver receives data indicating that the stimulator is not active and the logic circuit determines that the proposed change would increase the stimulation, and

wherein the processor is configured to allow the change to the stimulus when the logic circuit determines that the proposed change would not increase the stimulation irrespective of whether the implanted device is active or inactive.

23. The system of claim 22, wherein the processor is configured to reject the change to the stimulus when the data receiver receives data indicating that the stimulator is not active.

24. A method comprising:

receiving a stimulation adjustment at an extracorporeal portion of a system for stimulating tissue, the stimulation adjustment proposing a change to one or more aspects of an stimulus to be delivered by an implanted stimulation device to elicit a response from a tissue;

at the extracorporeal portion of the system for stimulating tissue, deciding whether the proposed stimulation adjustment is appropriate by determining if the proposed stimulation adjustment would yield a stimulation parameter outside a range of values of the stimulation parameter, the stimulation parameter characterizing the stimulus to be delivered by the implanted stimulation device;

at the extracorporeal portion, if the proposed stimulation adjustment is appropriate,

determining a setting for the stimulation parameter based on the proposed stimulation adjustment and

transmitting the stimulation parameter setting to the implanted stimulation device;

at the implanted stimulation device, receiving the stimulation parameter setting from the extracorporeal portion; and

at the extracorporeal portion, if the proposed stimulation adjustment is not appropriate,

automatically altering the proposed stimulation adjustment to a value within the range of values of the stimulation parameter.

25. The method of claim 24, wherein determining if the proposed stimulation adjustment is appropriate comprises:

retrieving a stored stimulation boundary from the implanted portion; and

determining if the proposed stimulation adjustment is within the boundary retrieved from the implanted portion.

26. The method of claim 24, wherein determining if the proposed stimulation adjustment is appropriate comprises:

accessing a range value identifying a range of values of a stimulation parameter relative to a first value, the stimulation parameter characterizing the stimulus to be delivered by the stimulation device; and

determining if the proposed stimulation adjustment is within the range identified by the range value.

27. The method of claim 24, wherein transmitting the stimulation parameter setting to the implanted stimulation device comprises transmitting an incremental or decremental change to the stimulation parameter setting.

28. A method comprising:

at an extracorporeal portion of a system for delivering a stimulus to elicit a response from a tissue, comparing a stimulation parameter that would be yielded by a proposed adjustment to the stimulation parameter to a range of values of the stimulation parameter, the stimulation parameter characterizing the electrical signal to be delivered by an implanted portion of the system;

determining, based on the comparison, that the proposed adjustment is inappropriate if the proposed adjustment would violate a boundary on the range of values; and

accommodating the proposed stimulation adjustment by changing a setting of the stimulation parameter to the violated boundary.

29. The method of claim 28, wherein accommodating the proposed stimulation adjustment comprises transmitting the setting of the stimulation parameter from the extracorporeal portion to the implanted portion.

30. The method of claim 28, wherein accommodating the proposed stimulation adjustment comprises incrementing or decrementing the setting of the stimulation parameter to the violated boundary.

31. The method of claim 28, wherein accommodating the proposed stimulation adjustment comprises transmitting a revised stimulation adjustment from the extracorporeal portion to the implanted portion.

32. A method comprising:

receiving, at an extracorporeal device, a proposed adjustment to a stimulus to be delivered by an implanted device, the stimulus to elicit a response from a tissue;

determining whether the implanted device is active;

determining whether the proposed adjustment would increase the stimulation provided by the stimulus; and

if the implanted device is not active, rejecting the adjustment to leave the stimulus unchanged if the stimulation would be increased, but if the stimulation would not be increased, then allowing the proposed adjustment irrespective of whether the implanted device is active or inactive.