Method and apparatus for neuromodulation treatments of pain and other conditions

• US 10,335,596 B2
• Filed: 12/20/2016
• Issued: 07/02/2019
• Est. Priority Date: 03/14/2014
• Status: Active Grant

• Current Assignee: Nalu Medical, Inc.
• Original Assignee: Nalu Medical, Inc.
• Inventors: Yakovlev, Anatoly, Pivonka, Daniel, Palmer, Logan
• Primary Examiner(s): Porter, Allen
• Application Number:
  US15/385,729
• Publication Number:
  US 20170095667A1
• Time in Patent Office: 924 Days
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/40 Detecting, measuring or recording for evaluating the nervous system A61B5/4806, A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4824 Touch or pain perception evaluation A61B5/4821 takes precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 : Details of circuitry or electric components
• CPC Class Codes: A61N 1/362 : Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37229 : Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37235 : Aspects of the external programmer
• CPC Class Codes: A61N 1/37288 : Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: A61N 2/002 : in combination with another treatment
• CPC Class Codes: A61N 2/006 : for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/008 : for pain treatment or analgesia
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: H02J 2310/23 : The load being a medical device, a medical implant, or a life supporting device
• CPC Class Codes: H02J 50/00 : Circuit arrangements or systems for wireless supply or distribution of electric power
• CPC Class Codes: H02J 7/00034 : Charger exchanging data with an electronic device, i.e. telephone, whose internal battery is under charge

Abstract

Systems, devices, and methods for neurostimulation using a combination of implantable and external devices to treat pain are disclosed.

Claims

1. An apparatus for delivering stimulation energy to tissue, comprising:

an implantable device comprising an implantable energy storage element and at least one implantable antenna, the implantable device configured to deliver stimulation energy to tissue;

an external device comprising an external antenna, the external device configured to transmit power and data to the implantable device via a wireless link;

wherein the apparatus is configured to assess quality of the wireless link by assessing rate of charging of the implantable energy storage element,

wherein the apparatus is configured to perform the assessment of the quality of the wireless link periodically,

wherein the apparatus is further configured to increase power level of transmissions during the performance of the assessment, and

wherein the apparatus is further configured to reduce the power level of the external device transmissions until a discharge rate of the implantable energy storage element is faster than the charge rate of the energy storage element.

2. The apparatus according to claim 1, wherein the apparatus is further configured to assess at least one of relative wireless link quality information or absolute wireless quality link information.

3. The apparatus according to claim 1, wherein the quality of the wireless link is adjustable by a user adjusting external antenna orientation.

4. The apparatus according to claim 1, wherein the quality of the wireless link is adjustable by adjusting a parameter selected from the group consisting of:

external device antenna position;

external device output power level;

external device operating frequency;

parameter of an impedance matching network; and

combinations thereof.

5. The apparatus according to claim 1, wherein the apparatus is further configured to notify the external device when the implantable device has received sufficient power to turn on.

6. The apparatus according to claim 1, wherein the apparatus is further configured to adjust the power level of the external device transmissions to the implantable device.

7. The apparatus according to claim 6, wherein the apparatus is configured to increase the power level of the external device transmissions during the assessment of the quality of the wireless link.

8. The apparatus according to claim 7, wherein increasing the power level increases speed of the assessment of the quality of the wireless link.

9. The apparatus according to claim 6, wherein the apparatus is configured to adjust the power level based on a parameter selected from the group consisting of:

a stimulation therapy parameter;

charge rate of the implantable energy storage element;

discharge rate of the implantable energy storage assembly; and

combinations thereof.

10. The apparatus according to claim 6, wherein the apparatus is configured to adjust the power level during an event selected from the group consisting of:

event in which patient physical activity varies;

event in which environmental conditions change;

event in which wireless link gain changes; and

combinations thereof.

11. The apparatus according to claim 6, wherein the apparatus is configured to adjust the power level during data transmission and/or reception phases.

12. The apparatus according to claim 6, wherein the adjusting of the power level can comprise bursts of high power delivered by the external device to quickly charge the implantable energy storage element.

13. The apparatus according to claim 1, wherein the apparatus is further configured to prevent unintended operation by monitoring a parameter selected from the group consisting of:

a therapy parameter;

a wireless data link parameter;

wireless power link parameter;

a sensing circuitry parameter;

an antenna parameter;

an impedance parameter; and

combinations thereof.

14. The apparatus according to claim 1, wherein the apparatus is further configured to use a gradient search algorithm to maximize quality of the wireless link.

15. The apparatus according to claim 1, wherein the apparatus further comprises a safety protocol and a kill switch, wherein the apparatus is further configured to shut down and notify the user if an undesired condition is detected.

16. The apparatus according to claim 15, wherein the safety protocol is configured to monitor a parameter selected from the group consisting of:

temperature of the apparatus;

temperature of the external device;

a wireless power link parameter;

impedance mismatch;

electric current draw;

bit error rate;

antenna failure;

reflection coefficient;

standing wave ratio; and

combinations thereof.

17. The apparatus according to claim 15, wherein the apparatus is configured to perform a calibration of an undesired condition if determined by the safety protocol.

18. The apparatus according to claim 1, wherein the external device is configured to deliver power at a first power level during stimulation and a second power level during the assessment of the quality of the wireless link, and wherein the second power level is higher than the first power level.

19. The apparatus according to claim 1, wherein the external device comprises an adhesive layer, and wherein the adhesive layer is a configured to adhesively attach to patient skin at a location over the implantable device.

20. The apparatus according to claim 1, wherein the implantable device comprises a shunting network, and wherein the implantable device is configured to discharge the implantable energy storage assembly via the shunting network based on a command from the external device.

21. The apparatus according to claim 1, wherein the implantable energy storage element comprises at least one of a battery or a capacitor.

22. An apparatus for delivering stimulation energy to tissue, comprising:

an implantable device comprising an implantable energy storage element and at least one implantable antenna, the implantable device configured to deliver stimulation energy to tissue;

an external device comprising an external antenna, the external device configured to transmit power and data to the implantable device via a wireless link;

wherein the apparatus is configured to assess quality of the wireless link by assessing rate of charging of the implantable energy storage element,

wherein the external device is configured to deliver power at a first power level during stimulation and a second power level during the assessment of the quality of the wireless link, and wherein the second power level is higher than the first power level.

23. The apparatus according to claim 22, wherein the apparatus is further configured to assess at least one of relative wireless link quality information or absolute wireless quality link information.

24. The apparatus according to claim 22, wherein the quality of the wireless link is adjustable by a user adjusting external antenna orientation.

25. The apparatus according to claim 22, wherein the quality of the wireless link is adjustable by adjusting a parameter selected from the group consisting of:

external device antenna position;

external device output power level;

external device operating frequency;

parameter of an impedance matching network; and

combinations thereof.

26. The apparatus according to claim 22, wherein the apparatus is further configured to notify the external device when the implantable device has received sufficient power to turn on.

27. The apparatus according to claim 22, wherein the apparatus is further configured to adjust the power level of the external device transmissions to the implantable device.

28. The apparatus according to claim 27, wherein the apparatus is configured to increase the power level of the external device transmissions during the assessment of the quality of the wireless link.

29. The apparatus according to claim 28, wherein increasing the power level increases speed of the assessment of the quality of the wireless link.

30. The apparatus according to claim 27, wherein the apparatus is configured to adjust the power level based on a parameter selected from the group consisting of:

a stimulation therapy parameter;

charge rate of the implantable energy storage element;

discharge rate of the implantable energy storage assembly; and

combinations thereof.

31. The apparatus according to claim 27, wherein the apparatus is configured to adjust the power level during an event selected from the group consisting of:

event in which patient physical activity varies;

event in which environmental conditions change;

event in which wireless link gain changes; and

combinations thereof.

32. The apparatus according to claim 27, wherein the apparatus is configured to adjust the power level during data transmission and/or reception phases.

33. The apparatus according to claim 27, wherein the adjusting of the power level can comprise bursts of high power delivered by the external device to quickly charge the implantable energy storage element.

34. The apparatus according to claim 22, wherein the apparatus is configured to perform the assessment of the quality of the wireless link periodically.

35. The apparatus according to claim 34, wherein the apparatus is further configured to increase power level of transmissions during the performance of the assessment.

36. The apparatus according to claim 22, wherein the apparatus is further configured to prevent unintended operation by monitoring a parameter selected from the group consisting of:

a therapy parameter;

a wireless data link parameter;

wireless power link parameter;

a sensing circuitry parameter;

an antenna parameter;

an impedance parameter; and

combinations thereof.

37. The apparatus according to claim 22, wherein the apparatus is further configured to use a gradient search algorithm to maximize quality of the wireless link.

38. The apparatus according to claim 22, wherein the apparatus further comprises a safety protocol and a kill switch, wherein the apparatus is further configured to shut down and notify the user if an undesired condition is detected.

39. The apparatus according to claim 38, wherein the safety protocol is configured to monitor a parameter selected from the group consisting of:

temperature of the apparatus;

temperature of the external device;

a wireless power link parameter;

impedance mismatch;

electric current draw;

bit error rate;

antenna failure;

reflection coefficient;

standing wave ratio; and

combinations thereof.

40. The apparatus according to claim 39, wherein the apparatus is configured to perform a calibration of an undesired condition is determined by the safety protocol.

41. The apparatus according to claim 22, wherein the external device comprises an adhesive layer, and wherein the adhesive layer is a configured to adhesively attach to patient skin at a location over the implantable device.

42. The apparatus according to claim 22, wherein the implantable device comprises a shunting network, and wherein the implantable device is configured to discharge the implantable energy storage assembly via the shunting network based on a command from the external device.

43. The apparatus according to claim 22, wherein the implantable energy storage element comprises at least one of a battery or a capacitor.