Regional therapies for treatment of pain

• US 20070039625A1
• Filed: 03/14/2006
• Published: 02/22/2007
• Est. Priority Date: 06/09/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Singhal, Ruchika, Schendel, Michael, Heruth, Kenneth, Lent, Mark
• Granted Patent: US 8,244,360 B2
• Time in Patent Office: Days
• US Class Current: 128/898
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

Systems and methods for coordinated delivery of a therapeutic agent and low (less than about 20 Hz) and high (greater than about 50 Hz) frequency stimulation therapy are described. The systems include a control unit for coordinating therapy delivery between an infusion device and a pulse generator, such that a therapeutic agent is administered at a predetermined time relative to application of either low frequency or high frequency stimulation. For example, the control unit may instruct the infusion device to deliver therapeutic agent at a predetermined time prior to delivery of low frequency stimulation. Systems that include more than one infusion device or an infusion pump capable of delivering more than one therapeutic agent are also described.

Claims

1. A system comprising:

a pulse generator capable of alternating between generation of a first electrical signal and generation of a second electrical signal; and

a first infusion device capable of delivering a first therapeutic agent at a first rate at a first predetermined time based on when the pulse generator switches from generation of the first signal to generation of the second signal; and

a control unit configured to coordinate the delivery of the first therapeutic agent at the first rate from the first infusion device with the switch from the generation of the first signal to the generation of the second signal.

2. The system of claim 1, wherein the control unit is capable of providing information to the infusion device regarding when the pulse generator switches from generation of the first signal to generation of the second signal.

3. The infusion system of claim 1, wherein the control unit instructs the first infusion device when to deliver the first therapeutic agent.

4. The system of claim 1, wherein the control unit is an external programmer unit.

5. The system of claim 4, wherein the external programmer unit provides instructions regarding therapy delivery to both the pulse generator and the first infusion device.

6. The system of claim 5, wherein the external programmer informs the first infusion device regarding when the pulse generator will switch from generation of the first signal to generation of the second signal at the time the programmer provides instructions regarding therapy to the first infusion device.

7. The system of claim 1, wherein the control unit and the first infusion device are housed within a single housing.

8. The system of claim 7, wherein the control unit is configured to communicate wirelessly with the pulse generator.

9. The system of claim 1, wherein the pulse generator and the control unit are configured communicate wirelessly.

10. The system of claim 9, wherein the first infusion device and the control unit are configured to communicate wirelessly.

11. The system of claim 1, wherein the first infusion device and the control unit are configured communicate wirelessly.

12. The system of claim 1, wherein the first infusion device is capable of delivering the first therapeutic agent at a second rate at a second predetermined time from when the pulse generator switches from generation of the first signal to generation of the second signal, and wherein the control unit is further configured to coordinate the delivery of the first therapeutic agent at the second rate from the first infusion device with the switch from the generation of the first signal to the generation of the second signal.

13. The system of claim 1, wherein the first infusion device is capable of delivering the first therapeutic agent at a second rate at a second predetermined time from when the pulse generator switches from generation of the second signal to generation of the first signal, and wherein the control unit is further configured to coordinate the delivery of the first therapeutic agent at the second rate from the first infusion device with the switch from the generation of the second signal to the generation of the first signal.

14. The system of claim 1, further comprising a second infusion device capable of delivering a second therapeutic agent at a second predetermined time from when the pulse generator switches from generation of the first signal to generation of the second signal,

wherein the control unit is further configured to coordinate the delivery of the second therapeutic agent from the second infusion device with the switch from the generation of the first signal to the generation of the second signal, and

wherein the second predetermined time is the same or different than the first predetermined time.

15. The system of claim 1, further comprising a second infusion device capable of delivering a second therapeutic agent at a predetermined time from when the pulse generator switches from generation of the second signal to generation of the first signal, wherein the control unit is further configured to coordinate the delivery of the second therapeutic agent from the second infusion device with the switch from the generation of the second signal to the generation of the first signal.

16. The system of claim 1, further comprising a first reservoir and a second reservoir operably coupled to the first infusion device, the first reservoir being configured to house the first therapeutic agent.

17. The system of claim 16, wherein the second reservoir is configured to house a second therapeutic agent.

18. The system of claim 17, wherein the first infusion device is further capable of delivering the second therapeutic agent at a second predetermined time based on when the pulse generator switches from generation of the first signal to generation of the second signal,

wherein the control unit is further configured to coordinate the delivery of the second therapeutic agent from the first infusion device with the switch from the generation of the first signal to the generation of the second signal, and

wherein the first predetermined time and the second predetermined time is the same or different.

19. The system of claim 17, wherein the first infusion device is further capable of delivering the second therapeutic agent at a second predetermined time based on when the pulse generator switches from generation of the second signal to generation of the first signal, wherein the control unit is further configured to coordinate the delivery of the second therapeutic agent from the first infusion device with the switch from the generation of the second signal to the generation of the first signal.

20. A system comprising:

(a) a pulse generator capable of alternating between generation of a first electrical signal and generation of a second electrical signal; and

(b) an infusion device capable of

(i) initiating delivery of first therapeutic agent at a first rate during a time when the pulse generator generates the first signal and

(ii) ceasing delivery of the first therapeutic agent at the first rate during a time when the pulse generator generates the second signal; and

(c) a control unit configured to coordinate the initiation of delivery of the first therapeutic agent from the first infusion device with the generation of the first signal and the cessation of delivery of the first therapeutic agent from the first infusion device with the generation of the second signal.

21. A system comprising:

(a) an infusion device capable of delivering a therapeutic agent at a predetermined rate;

(b) a pulse generator capable of generating a first electrical signal and a second electrical signal; and

(c) a control unit configured to coordinate

(i) generation of the first electrical signal by the pulse generator during a time when the infusion device is delivering the therapeutic agent at the predetermined rate and

(ii) generation of the second electrical signal by the pulse generator at a time when the infusion device is delivering the therapeutic agent at a rate other than the predetermined rate.

22. A system comprising:

means for delivering to a subject a first therapeutic agent;

means for delivering to the subject a first electrical signal having a first frequency;

means for delivering to the subject a second electrical signal having a second frequency;

means for controlling whether the first or second electrical signal is delivered to the subject; and

means for controlling timing of the administration of an amount of the first therapeutic agent based on whether the first or second electrical signal is being delivered.

23. The system of claim 22, wherein the means for controlling timing of the administration of the amount of the first therapeutic agent controls the timing of the administration based on a switch from administering the first electrical signal to administering the second electrical signal.

24. The system of claim 22, further comprising means for delivering to a subject a second therapeutic agent, wherein

the means for controlling the timing of the administration of an amount of the first therapeutic agent is further configured to control whether the second therapeutic agent is delivered to the subject based on whether the first or second electrical signal is being delivered.

25. A system comprising:

a pulse generator capable of alternating between generation of a first and second electrical signal, the first and second electrical signal having different frequencies;

a first infusion device configured to deliver a first therapeutic agent at a first rate at a first predetermined time in response to a switch between generation of the first electrical signal to generation of the second electrical signal; and

a second infusion device configured to deliver a second therapeutic agent at a second predetermined time at a second rate in response to a switch between generation of the second electrical signal and the first electrical signal,

wherein the first and second infusion devices are the same or different, the first and second predetermined times are the same or different, and the first and second rates are the same or different.

26. A system comprising:

a pulse generator capable of alternating between generation of a first electrical signal and generation of a second electrical signal; and

an infusion device configured to deliver a first therapeutic agent at a predetermined time from when the pulse generator switches from generation of the first signal to generation of the second signal.

27. A method comprising:

identifying whether a first predetermined electrical signal is being generated by an implantable pulse generator; and

instructing an infusion device to deliver a therapeutic agent at a rate if the predetermined electrical signal is being generated.

28. A method comprising:

instructing an implantable pulse generator to generate a first and a second electrical signal at predetermined times, and

instructing an infusion device to deliver a therapeutic agent at a predetermined time relative to generation of the first or second electrical signal.