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

• US 7,776,031 B2
• Filed: 08/18/2004
• Issued: 08/17/2010
• 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.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US10/921,015
• Publication Number:
  US 20050020996A1
• Time in Patent Office: 2,190 Days
• Field of Search: 604/890.1, 604/891.1, 604/500, 604/502, 604/65, 604/66, 604/67, 604/288.01, 604/503, 604/31
• US Class Current: 604/891.1
• 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. A method for providing a drug therapy in an automatic drug therapy delivery system, the method comprising:

(a) implanting at least one implantable pump into a patient;

(b) programming a dose infusion characteristic value into a programmable memory location using a radio frequency signal, the dose infusion characteristic value selected from the group consisting of a base rate drug flow, a maximum allowable dose for a predetermined period of time, a minimum allowable dose for a predetermined period of time, a patient activation request, drug monitoring delivery data, a rolling average rate limit for a predetermined period of time, a nominal dosage rate, and a minimum time interval between bolus requests;

(c) delivering using the at least one implantable pump, in response to a patient originated stimulus, a bolus of a first drug to the patient in response to an input signal received by a programmable controller upon the determination of the programmable controller that the bolus is compliant with the dose infusion characteristic;

(d) determining a first amount of the first drug and a second amount of a second drug delivered to the patient;

(e) determining whether there exists a risk of overdosage or underdosage of the drug therapy;

(f) if a risk of overdosage or underdosage is determined, notifying the patient;

(g) sensing an efficacy of a treatment based on the first drug and the second drug; and

(h) determining a first alternative dosage of the first drug and a second alternative dosage of the second drug from the sensed efficacy.

2. The method of claim 1 wherein the dose infusion characteristic limits the drug bolus frequency.

3. The method of claim 1 wherein the dose infusion characteristic limits the drug bolus size.

4. The method of claim 1 wherein the dose infusion characteristic limits the drug bolus frequency and size.

5. The method of claim 1 wherein the dose infusion characteristic is programmed into the programmable controller by a patient care provider.

6. The method of claim 1 wherein the programmable controller is programmable using a radio frequency programming link.

7. The method of claim 1, further comprising:

sensing efficacy of the bolus.

8. The method of claim 1, wherein the alternative dosage is limited by a dose limit.

9. A method of providing controlled treatment therapy to a patient using at least one implantable pump, comprising:

(a) implanting at least one implantable pump into a patient;

(b) receiving from a health care provider a set of drug dosage limit information for a first drug and a second drug describing at least one drug therapy dosage limit, the at least one drug therapy limit selected from the group consisting of a base rate drug flow, a maximum allowable dose for a predetermined period of time, a minimum allowable dose for a predetermined period of time, a patient activation request, drug monitoring delivery data, a rolling average rate limit for a predetermined period of time, a nominal dosage rate, and a minimum time interval between bolus requests;

(c) receiving from the patient drug delivery instructions describing a first amount for a first drug and a second amount for a second drug to be delivered;

(d) storing in memory historical information relating to the first and second amounts delivered to the patient;

(e) sensing an efficacy of the first and second drugs delivered to the patient based on the historical information; and

(f) separately administering the first drug and the second drug based on the sensed efficacy using the at least one implantable pump.

10. The method of claim 9, further comprising:

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

11. The method of providing a controlled treatment therapy of claim 10, wherein the notification mechanism is a LCD display.

12. The method of providing a controlled treatment therapy of claim 10, wherein the notification mechanism is an enunciator.

13. The method of providing a controlled treatment therapy of claim 9, wherein the drug dosage limit information is selected from the group consisting of maximum daily dosage, minimum daily dosage, and bolus dosage.

14. The method of claim 9, further comprising:

determining an alternate dosage based on the sensed efficacy, the alternate dosage limited by a dose limit.

15. An apparatus that is implantable into a patient and that provides a drug therapy, the apparatus comprising:

a processor;

a memory having stored therein machine executable instructions, that when executed, cause the apparatus to;

sense an efficacy of a treatment, wherein the treatment incorporates a first drug and a second drug; and

separately administer within the patient the first drug and the second drug based on the sensed efficacy and a dose infusion characteristic value selected from the group consisting of a base rate drug flow, a maximum allowable dose for a predetermined period of time, a minimum allowable dose for a predetermined period of time, a patient activation request, drug monitoring delivery data, a rolling average rate limit for a predetermined period of time, a nominal dosage rate, and a minimum time interval between bolus requests using at least one implantable pump.

16. The apparatus of claim 15, wherein the instructions further cause the apparatus to:

administer the first drug and the second drug at different rates and different times.