Pump diagnostic system

• US 5,006,997 A
• Filed: 02/26/1990
• Issued: 04/09/1991
• Est. Priority Date: 12/15/1987
• Status: Expired due to Term

• Current Assignee: Flowonix Medical, Inc.
• Original Assignee: Shiley Infusaid Incorporated
• Inventors: Reich, Sanford
• Primary Examiner(s): Lall, Parshotam S.
• Assistant Examiner(s): Mattson, Brian M.
• Application Number:
  US07/484,284
• Time in Patent Office: 407 Days
• Field of Search: 364/509, 364/510, 364/556, 364/413.02, 364/413.03, 364/413.07, 340/603, 340/606-611, 128/DIG. 12, 128/DIG. 13, 128/748, 604/27, 604/28, 604/30, 604/31, 604/65, 604/67, 604/131, 604/901
• US Class Current: 600/561
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A method and apparatus to evaluate the performance of an implanted medication delivery device such as pumps and ports is described. In the case of a pump, the system measures ambient pressure and obtains two pressure measurements from the implanted device. One of these measurements is device reservoir pressure and the other is based on a disturbance pulse injected into the system at a point downstream of the reservoir. Based on those measurements and input calibration data, an expected flow rate is determined. The expected flow rate together with device refill data is in turn used to determine a normalized flow rate for the in-vivo device. Determinations are then made as to the performance of the reservoir, its pump and the condition of the outlet catheter without explant of the device. In the case of a port, the system measures the catheter resistance based on decay time of a disturbance pulse.

Claims

1. A system for evaluating operation of an in-vivo medication delivery device having a medication reservoir with a fluid therein for delivery, a separate access port and an outlet in fluid communication thereto comprising:

means for detaining ambient pressure,

means for determining an in-vivo pressure in said reservoir,

means for determining a pressure in said medication delivery device at a posit in a flow path of said fluid downstream of said reservoir, and

means receiving values representative of said in-vivo pressure, said pressure downstream of said reservoir and ambient pressure to determine whether said medication delivery device is functioning within predetermined limits.

2. The system of claim 1 wherein said means to determine whether said medication delivery device is functioning within predetermined limits comprises means to determine whether said reservoir requires refilling.

3. The system of claim 1 wherein said means to determine whether said medication delivery device is functioning within predetermined limits comprises means to determine whether said outlet is blocked or leaking.

4. The system of claim 1 wherein said means to determine whether said medication delivery device is functioning within predetermined limits comprises means to determine whether said reservoir is releasing medication to said outlet at a predetermined rate.

5. The system of claim 1 wherein said means to determine the pressure in said reservoir comprises a needle and a pressure transducer, said needle penetrating into said reservoir and said pressure transducer producing an output signal that is input to said means to determine whether said medication delivery device is functioning within predetermined limits.

6. The system of claim 1 further comprising means for inputting data as to previous performance and refill data for the medication delivery device under evaluation into said means to determine whether said device is functioning within predetermined limits.

7. The system of claim 6 wherein said means to determine whether said device is functioning within predetermined limits comprises processor means, said processor means including a read only memory storing equations used to determine device performance and a random access memory for storing determined pressure values and input data.

8. A method of evaluating operation of an in-vivo medication delivery device having a medication reservoir having a fluid for delivery in-vivo, an access port and an outlet in fluid communication thereto, comprising the steps of:

determining, ambient pressure, in-vivo reservoir pressure and in-vivo pressure in said delivery device at a point downstream of said reservoir, and

evaluating, based on the determined pressures, whether said in-vivo device is functioning within predetermined limits.

9. The method as in claim 8, wherein said step of evaluating comprises the step of determining whether said medication reservoir is depleted or has failed to deliver medication.

10. The method as in claim 8, wherein said step of evaluating comprises the step of determining whether said outlet is leaking or is blocked.

11. The method as in claim 8 wherein said step of evaluating comprises the step of determining an expected flow rate of said medication delivery device as a function of determined pressures and calibration data for a particular device under evaluation.

12. The method as in claim 11, further comprising the step of determining a normalized flow rate for said device based on the determination of the expected flow rate and data relating to refill volumes and intervals between refills.

13. The method as in claim 8, wherein the determination of in-vivo pressure at a point in a flow path of said fluid downstream of said reservoir comprises the steps of puncturing said access port with a needle, generating a pressure disturbance pulse in said outlet and measuring a decay time of said pressure disturbance pulse.

14. The method as in claim 8 further comprising the steps of calculating a normalized flow rate for said device and storing said flow rate.

15. A method of determining whether an implanted medication delivery device is functioning within predetermined limits comprising the steps of measuring ambient pressure:

determining a normalized flow rate for said device based on in-vivo pressure measurements, calibration data and device refill data, and

determining, without explant of said device, whether said device requires refill or has malfunctioned.

16. The method as in claim 15 further comprising the step of generating a pressure disturbance pulse in an outlet of said device, measuring a decay time of said pulse, and determining whether said outlet is blocked or is leaking.

17. The method as in claim 15 further comprising the step of measuring in-vivo pressure of a reservoir of said device and in-vivo pressure at a point in said device in a flow path for said fluid between said reservoir and an outlet.

18. A method of determining whether an implanted medication delivery device is functioning within normal limits comprising the steps of measuring ambient pressure:

measuring a flow resistance based on in-vivo measurements, and

determining, without explant of said device, whether said device is dispensing medication within predetermined limits.

19. The method as in claim 18 wherein said step of measuring flow resistance comprises steps of measuring a steady state in-vivo pressure in said device and generating a pressure disturbance pulse in said device and measuring a decay time thereof.

20. The method as in claim 18 wherein the step of determining whether said device is dispensing medication within predetermined limits comprises determining whether said device is blocked or is leaking.

21. A system for evaluating operating of an in-vivo medication delivery device having an access port and an outlet comprising:

means in fluid communication with said device for determining a steady state in-vivo pressure in said device,

means in fluid communication with said device for generating a pressure disturbance pulse in said device and determining a decay time thereof, and

means responsive to said means for determining a steady state in-vivo pressure and said means for generating a pressure disturbance for determining whether said device is functioning within predetermined limits.

22. The system of claim 21 wherein said means to determine whether said device is functioning within predetermined limits comprises means receiving values of said steady state pressure and said decay time and determining whether said device is blocked or is leaking.