Therapeutic treatment of disorders based on timing information

• US 6,923,784 B2
• Filed: 10/31/2001
• Issued: 08/02/2005
• Est. Priority Date: 04/30/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stein, Marc T.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/000,638
• Publication Number:
  US 20020038137A1
• Time in Patent Office: 1,371 Days
• Field of Search: 604/65, 604/66, 604/67, 604/93, 604/891.1, 128/13, 128/DIG.12
• US Class Current: 604/67
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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 1/36071 Pain

Abstract

Disclosed are techniques for operation of neurostimulation or drug delivery devices to stop treatment therapy during times when the patient does not need to be treated. Advantageously, the present invention reduces battery usage and/or drug dosage during periods when treatment therapy need not be provided. Further, the present invention slows or reduces the tolerance the patient may develop from the electrical stimulation or treatment therapy. In one embodiment, the present invention includes a timer or a real time clock for shutting off the device during periods when the patient is sleeping in accordance with a preset schedule. The present invention preferably turns off after the patient has fallen asleep and right before the patient has awakened. Alternatively, the invention may include a sensor for sensing conditions indicative of whether the patient is awake or asleep. This sensed information may also be used to determine whether the treatment therapy should be delivered or stopped.

Claims

1. A drug delivery system device for treatment of a disorder comprising in combination:

(a) an implantable pump having at least one reservoir for storing at least one drug;

(b) a real time clock coupled to the pump and providing time-of-day information to establish whether the pump is to deliver the drug;

(c) at least one implantable catheter coupled to the pump and adapted to deliver the drug to at least one predetermined site in a body of a patient; and

(d) a sensor coupled to the pump for generating a signal indicative of whether a patient is asleep or awake, wherein the pump is responsive to the signal.

2. A drug delivery system of claim 1, further comprising:

(e) an analog-to-digital converter coupling the sensor to the pump.

3. In an implanted drug delivery device for treatment of a disorder having an implantable pump and at least one implantable catheter coupled to the pump, a method of automatically starting and stopping delivery of treatment therapy to a patient comprising the steps of:

(a) calibrating the implantable pump with at least two parameters for determining whether treatment is to be delivered, a first parameter corresponding to a first time of day indicating that the therapy is to be started and a second parameter corresponding to a second time of day indicating that the therapy is to be stopped;

(b) monitoring a timer to determine whether at least one of the parameters is satisfied;

(c) if the first parameter is satisfied, automatically initiating the implantable pump to start delivering drug treatment therapy to the patient; and

(d) if the second parameter is satisfied, automatically initiating the implantable pump to stop the delivery of the drug treatment therapy.

4. A method of claim 3, wherein a third parameter corresponds to a pattern indicative of whether the patient is asleep or awake and further comprising the step of:

(e) if the third parameter indicates that the patent is awake, automatically initiating the implantable pump to start delivering drug treatment therapy to the patient; and

(f) if the third parameter indicates that the patient is asleep, automatically initiating the implantable pump to stop the delivery of the drug treatment therapy.

5. A method of claim 3, wherein the disorder is selected from the group consisting of pain, movement disorder and epilepsy.

6. A system for automatically starting and stopping delivery of treatment therapy to a patient comprising in combination:

(a) an implantable pump;

(b) at least one implantable catheter coupled to the implantable pump and adapted to deliver at least one drug to at least one site in a body of a patient;

(c) a timer providing timing information; and

(d) means responsive to the timer for causing the implantable pump to start delivering drug treatment therapy to the patient if the timing information satisfies a first time of day parameter and for causing the implantable pump to stop delivering drug treatment therapy to the patient if the timing information satisfies a second time of day parameter.

7. The system of claim 6, wherein the means is a microprocessor.

8. The system of claim 6, wherein the means is a controller.

9. The system of claim 6, wherein the means is circuitry.

10. The system of claim 6, wherein the timer is a real time clock.

11. The system of claim 10, wherein the real time clock is configured to receive input from an external source to provide time of day information.

12. The system of claim 6, further comprising:

(e) a sensor coupled to the implantable pump for generating a signal indicative of whether a patient is asleep or awake.

13. The system of claim 6, further comprising:

(e) a switch coupled to the implantable pump and responsive to input by a patient to allow the patient to manually turn off the device.

14. A system for automatically starting and stopping delivery of treatment therapy to a patient comprising in combination:

(a) an implantable pump;

(b) at least one implantable catheter coupled to the implantable pump and adapted to deliver the drug treatment therapy to at least one site in a body of a patient;

(c) a sensor that provides information as to whether the patient is asleep or awake; and

(d) means responsive to the sensor for causing the implantable pump to start delivering drug treatment therapy if the patient is awake and for causing the implantable pump to stop delivering drug treatment therapy if the patient is asleep.

15. The system of claim 14, wherein the means is a microprocessor.

16. The system of claim 14, wherein the means is a controller.

17. The system of claim 14, wherein the means is circuitry.

18. The system of claim 14, wherein the sensor is coupled to the implantable pump utilizing an analog-to-digital converter.

19. The system of claim 14, further comprising:

(e) a real-time clock coupled to the implantable pump for providing timing information.

20. The system of claim 19, wherein the real time clock is configured to receive input from an external source to provide time of day information.

21. The system of claim 14, further comprising:

(e) a switch coupled to the signal generator and responsive to input by a patient to allow the patient to manually turn off the device.

22. A method of automatically starting and stopping delivery of treatment therapy to a patient with an implantable pump having at least one implantable catheter coupled to the implantable pump, comprising the steps of:

(a) sensing by a sensor a characteristic of the patient to determine whether the patient is awake or asleep;

(b) if the sensor indicates that the patient is awake, causing the implantable pump to start delivering drug treatment therapy to the patient; and

(c) if the sensor indicates that the patient is asleep, causing the implantable pump to stop delivering drug treatment therapy to the patient.

23. The method of claim 22, wherein the step of sensing includes the step of sensing motion by the patient.

24. The method of claim 22, wherein the step of sensing includes the step of sensing a heart rate of the patient.

25. The method of claim 22, wherein the step of sensing includes the step of sensing respiration of the patient.

26. The method of claim 22, wherein the step of sensing includes the step of sensing a chemical characteristic of the patient.

27. The method of claim 22, wherein the step of sensing includes the step of sensing a chemical characteristic of the patient selected from the group consisting of oxygen partial pressure, carbon dioxide concentration, glucose concentration, and insulin concentration.

28. The method of claim 22, wherein the step of sensing includes the step of sensing whether eyes of the patient are open or closed.