Recondition process for a medication infusion pump

• US 5,257,971 A
• Filed: 03/16/1993
• Issued: 11/02/1993
• Est. Priority Date: 03/16/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Minimed Technologics, Ltd.
• Inventors: VanAntwerp, William P., Lord, Peter C.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US08/032,037
• Time in Patent Office: 231 Days
• Field of Search: 604/28, 604/49, 604/153
• US Class Current: 604/500
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

A method is provided for reconditioning a medication infusion pump by removal of accumulated medication deposits and the like to restore pump performance without requiring surgical removal of an implanted pump from a patient. The reconditioning process comprises sequential delivery of a buffer solution and a rinse solution to internal pump flow passages. The rinse solution is effective to dissolve medication deposits and the like within narrow pump flow passages before the rinse solution is neutralized by intermixing with the buffer solution. Dissolution of accumulated medication deposits results in restoration of pump performance substantially to original product specifications.

Claims

1. A method of reconditioning a medication infusion pump having a medication chamber for receiving and storing a supply of a selected medication, and a pump mechanism for delivering the medication in doses from the medication chamber to a patient, said reconditioning method comprising the steps of:

placing a selected buffer solution into the medication chamber;

operating the pump mechanism to draw a portion of the buffer solution from the medication chamber in an amount sufficient to substantially fill internal flow passages of the pump mechanism with the buffer solution;

placing a selected rinse solution into the medication chamber; and

operating the pump mechanism to draw a portion of the rinse solution from the medication chamber and into internal flow passages of the pump mechanism, whereby the rinse solution effectively contacts and cleans internal flow passage surfaces of the pump mechanism and then intermixes within the pump mechanism with the buffer solution for neutralization thereof.

2. A method as described in claim 1, wherein the selected rinse solution comprises:

an alkaline rinse solution provided in a concentration sufficient to dissolve medication deposits within the pump mechanism.

3. A method as described in claim 2, wherein said alkaline rinse solution has a pH greater than approximately 10.

4. A method as described in claim 2, wherein said alkaline rinse solution comprises a solution from the group consisting of sodium hydroxide solution, calcium hydroxide solution, an amines solution, and a phosphines solution.

5. A method as defined in claim 2, wherein the selected rinse solution comprises:

a sodium hydroxide solution.

6. A method as defined in claim 5, wherein the selected rinse solution comprises:

an approximately 0.01 Molar sodium hydroxide solution.

7. A method as described in claim 1, wherein the selected rinse solution comprises:

an acid rinse solution provided in a concentration sufficient to dissolve medication deposits within the pump mechanism.

8. A method as described in claim 7, wherein said acid rinse solution has a pH less than approximately 4.

9. A method as described in claim 7, wherein said acid rinse solution comprises a solution from the group consisting of hydrochloric acid, sulfuric acid, nitric acid, acetic acid, and Coca Cola.

10. A method as defined in claim 1, wherein the selected buffer solution comprises:

a phosphate buffer solution.

11. A method as defined in claim 10, wherein said phosphate buffer solution comprises:

an approximate 0.2 Molar potassium phosphate solution.

12. A method as defined in claim 1, wherein said step of operating the pump mechanism to draw a portion of the rinse solution from the medication chamber and into internal flow passages of the pump mechanism comprises:

operating the pump mechanism to pump a volume of between approximately 40 and 100 microliters of the rinse solution.

13. A method as defined in claim 12, wherein said step of operating the pump mechanism to draw a portion of the rinse solution from the medication chamber and into internal flow passages of the pump mechanism comprises:

operating the pump mechanism to pump a volume of between approximately 60 microliters of the rinse solution.

14. A method as defined in claim 1, wherein said step of operating the pump mechanism to draw a portion of the rinse solution from the medication chamber and into internal flow passages of the pump mechanism comprises:

operating the pump mechanism to pump a volume approximately equal to the volume of the pump and catheter plus approximately 10 microliters of the rinse solution.

15. A method as defined in claim 1, further comprising the step of:

aspirating residual medication from the medication chamber before placing the selected buffer solution therein.

16. A method as defined in claim 1, further comprising the step of:

aspirating residual buffer solution from the medication chamber before placing the selected rinse solution therein.

17. A method as defined in claim 1, further comprising the steps of:

aspirating residual rinse solution from the medication chamber after operating the pump mechanism to draw a portion of the rinse solution into flow passages of the pump mechanism; and

refilling the medication chamber with the selected medication.

18. A method as defined in claim 1, wherein the infusion pump comprises a refill fitting for injecting fluids into and aspirating fluid from the medication chamber, said steps of placing the buffer and rinse solutions into the medication chamber comprising:

injecting the solutions through the refill fitting.

19. A method as defined in claim 1, wherein said reconditioning method steps are performed in situ on a medication infusion pump implanted within the body of a patient.

20. In a medication infusion pump having a medication chamber for receiving and storing a selected medication, and a pump mechanism operable to draw the medication in doses from the medication chamber and to deliver the medication to a patient, a reconditioning method for cleaning medication deposits from internal flow passages of the pump mechanism, said method comprising the steps of:

placing a selected buffer solution into the medication chamber;

operating the pump mechanism to draw a sufficient quantity of the buffer solution from the medication chamber and into the pump mechanism to substantially fill the internal flow passages of the pump mechanism with the buffer solution;

removing residual buffer solution from the medication chamber;

placing a selected rinse solution into the medication chamber;

operating the pump mechanism to draw sufficient quantity of the rinse solution from the medication chamber to contact selected internal flow passage-defining surfaces of the pump mechanism to remove medication deposits from said selected internal surfaces, and in a quantity sufficiently less than the volumetric capacity of the pump mechanism internal flow passages whereby the rinse solution contacts and is substantially neutralized by buffer solution within the pump mechanism; and

removing residual rinse solution form the medication chamber.

21. A method as defined in claim 20, wherein the infusion pump is an implantable pump having a transcutaneously accessible refill fitting, and further wherein said solution placing and removing steps are performed transcutaneously with a hypodermic needle for respectively injecting solution into and aspirating solution from the medication chamber.

22. The method and claim 20, further comprising the step of:

aspirating residual medication from the medication chamber before placing the selected buffer solution therein.

23. A method as defined in claim 20, further comprising the step of:

filling the medication chamber with medication subsequent to said step of removing residual rinse solution therefrom.