Method and apparatus to control drug therapy dosages in an implantable pump

• US 20010037083A1
• Filed: 03/12/2001
• Published: 11/01/2001
• Est. Priority Date: 04/30/1999
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bourget, Duane L., Hartlaub, Jerome T.
• Granted Patent: US 6,796,956 B2
• Time in Patent Office: Days
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: G05B 19/106 for selecting a programme, variable or parameter
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

An implantable drug infusion pump for delivering drug therapy to a patient and which also permits a patient to deliver or self-administer an additional bolus, reduces the likelihood of over dosage or under dosage by drug dosage characteristic limitations programmed into a microprocessor memory. The dose limits define the maximum and minimum amount of drug to be delivered per unit time or otherwise, reducing the likelihood that a patient may inadvertently or deliberately interfere with a treatment regimen.

Claims

1. An automatic drug therapy delivery system, capable of being implanted into a patient comprised of:

a) at least one implantable reservoir of a drug to be administered to the patient;

b) an implantable, programmable pump coupled to the implantable reservoir, for delivering from the implantable reservoir at least one drug from the reservoir to the patient;

c) a programmable first memory module for storing a dose infusion characteristic;

d) a first input port receiving a first input signal from a patient so as to cause the pump to administer a bolus of drug, the bolus limited by the dose infusion characteristic;

e) a programmable microprocessor coupled to the programmable first memory module and to the first input port, the programmable microprocessor monitoring the amount of drug therapy administered to the patient according to instructions stored in the programmable first memory module and ensuring against overdosage or underdosage of the drug therapy; and

f) a programming link coupled to the implanted programmable pump for receiving instructions for the implantable programmable pump from outside the patient'"'"'s body and for programming the dose infusion characteristic.

2. The system of

claim 1

wherein the microprocessor performs the step selected from the group consisting of denying further activation requests, activating the smallest programmed dose when an activation request is made and prompting the patient to select the next lowest base rate, when an overdosage condition is detected.

3. The system of

claim 1

wherein the programmable first memory module is a memory device storing data controlling bolus dosage frequency.

4. The system of

claim 1

wherein the programmable first memory module is a memory device storing data controlling bolus dosage size per unit time.

5. The system of

claim 1

wherein the programmable first memory module is a memory device storing data for a dosage bolus size.

6. The system of

claim 1

wherein the programmable first memory module is a memory device capable of receiving data received from the programming link.

7. The system of

claim 1

further including an enunciator coupled to the pump.

8. The system of

claim 1

further including a piezoelectric enunciator coupled to the pump.

9. An automatic drug therapy delivery apparatus, capable of being implanted into a patient comprised of:

a) an implantable reservoir of a drug to be administered to the patient;

b) an implantable, programmable pump coupled to the implanted reservoir, for delivering from the implantable reservoir a programmable amount of drug from the reservoir to a patient;

c) at least one programmable memory location, storing a dose infusion characteristic;

d) a first input port receiving a first input signal from a patient so as to administer a bolus of drug, the bolus limited by the dose infusion characteristic;

e) a positive displacement pump coupled to and drawing drug material from the implantable reservoir;

f) a programmable microprocessor coupled to the at least one programmable memory location, the first input port and to the positive displacement pump, the programmable microprocessor monitoring the amount of drug therapy administered to the patient according to instructions stored in the programmable first memory module and ensuring against overdosage or underdosage of the drug therapy; and

g) a programming link coupled to the implantable programmable pump for receiving signals for the implanted programmable pump and for programming the dose infusion characteristic into the programmable memory location;

whereby the system based on historical drug usage by the patient notifies the patient of any underdosage or overdosage conditions.

10. The apparatus of

claim 9

wherein the remotely programmable pump includes a programmable microcontroller.

11. The apparatus of

claim 9

wherein the programmable controller includes at least one programmable memory device.

12. The apparatus of

claim 9

wherein the programmable controller includes at least one electrically erasable programmable read only memory.

13. The apparatus of

claim 9

wherein the at least one programmable memory location is a programmable memory device storing data controlling bolus dosage frequency.

14. The apparatus of

claim 9

wherein the at least one programmable memory location is a memory device storing data controlling bolus dosage size per unit time.

15. The apparatus of

claim 9

wherein the at least one programmable memory location is a memory device storing data for a dosage bolus size.

16. The apparatus of

claim 9

further including an enunciator coupled to the pump.

17. The apparatus of

claim 9

further including a piezoelectric enunciator coupled to the pump.

18. In an automatic drug therapy delivery system capable of being implanted into a patient, the system capable of being remotely programmed by radio frequency signals, the drug therapy system for delivering a bolus of drug to the patient in response to a patient-originated stimulus, the automatic drug therapy delivery system including a programmable controller having at least one input port through which signals from the patient are received by the controller and having at least one programmable memory location, a method of limiting the amount of patient-requested drug delivered to the patient comprised of the steps of:

a) programming at least one dose infusion characteristic value into the programmable memory location using a radio frequency signal;

b) delivering a bolus of a drug to the patient in response to an input signal received by the programmable controller upon the determination of the programmable controller that the bolus is compliant with the dose infusion characteristic;

c) determining the amount of drug delivered to a patient;

d) determining whether there exists a risk of overdosage or underdosage of the drug therapy; and

e) if a risk of overdosage or underdosage is determined, notifying the patient.

19. The method of

claim 18

wherein the dose infusion characteristic limits the drug bolus frequency.

20. The method of

claim 18

wherein the dose infusion characteristic limits the drug bolus size.

21. The method of

claim 18

wherein the dose infusion characteristic limits the drug bolus frequency and size.

22. The method of

claim 18

wherein the dose infusion characteristic is programmed into the programmable controller by a patient care provider.

23. The method of

claim 18

wherein the programmable controller is programmable using a radio frequency programming link.

24. A computer-readable medium having computer-executable instructions for performing steps comprising of:

a) storing historical base rates and bolus drug infusion rates for an implantable drug delivery device;

b) comparing the stored historical base rates and bolus drug infusion rates with prescribed dosage rate limits; and

c) if the compared rates indicate an overdosage or underdosage situation, then notifying the patient of the underdosage or overdosage conditions.

25. A method of providing controlled treatment therapy to a patient using an implantable pump, comprising the steps of:

(a) receiving from a health care provider a set of drug dosage limit information describing at least one drug therapy dosage limit;

(b) receiving from the patient drug delivery instructions describing an amount of drug to be delivered;

(c) storing in memory historical information relating to the amount of drug delivered to the patient; and

(d) displaying feedback in the form of a notification mechanism if the drug delivery approaches the drug therapy dosage limit.

26. The method of providing a controlled treatment therapy of

claim 25

, wherein the notification mechanism is a LCD display.

27. The method of providing a controlled treatment therapy of

claim 25

, wherein the notification mechanism is an enunciator.

28. The method of providing a controlled treatment therapy of

claim 25

, wherein the drug dosage limit information is selected from the group consisting of maximum daily dosage, minimum daily dosage, and bolus dosage.

29. A controller in communication with an implantable drug delivery device for delivering at least one drug to a patient, the controller comprising in combination:

(a) an input for receiving drug usage information and drug dosage limit information;

(b) a memory for storing therein the drug usage information and the drug dosage limit information; and

(c) a drug therapy program determining whether the drug information has reached the drug dosage limit information, and if so, notifying the patient of the condition.

30. The controller of

claim 29

, wherein the controller is part of the implantable drug delivery device and the pump further comprises telemetry providing bi-directional communication between the controller and an external device.

31. The controller of

claim 29

, wherein the controller part of an external programmer and the pump further comprises telemetry providing bi-directional communication between the external programmer and the pump.

32. The controller of

claim 29

, wherein the external programmer is a patient programmer.

33. The controller of

claim 29

, wherein the drug therapy program determines whether a drug delivery rate may be adjusted based on the drug usage information and the drug dosage limit information, and if so, notifying the patient of the condition.

34. A controller in communication with an implantable drug delivery device for delivering at least one drug to a patient, the controller comprising in combination:

(a) an input for receiving drug usage information and drug dosage limit information;

(b) a memory for storing therein the drug usage information and the drug dosage limit information; and

(c) a drug therapy program determining whether a drug delivery rate may be adjusted based on the drug usage information and the drug dosage limit information, and if so, notifying the patient of the condition.

35. The controller of

claim 34

, wherein the controller is part of the implantable drug delivery device and the pump further comprises telemetry providing bi-directional communication between the controller and an external device.

36. The controller of

claim 34

, wherein the controller part of an external programmer and the pump further comprises telemetry providing bi-directional communication between the external programmer and the pump.

37. The controller of

claim 34

, wherein the external programmer is a patient programmer.

38. A computer-readable medium having computer-executable instructions for performing steps comprising of:

a) storing historical base rates and bolus drug infusion rates for an implantable drug delivery device;

b) comparing the stored historical base rates and bolus drug infusion rates with prescribed dosage rate limits; and

c) if the compared rates indicate that drug delivery rate may be adjusted notifying the patient of the condition.