Drug delivery device and method

• US 7,291,126 B2
• Filed: 05/29/2003
• Issued: 11/06/2007
• Est. Priority Date: 11/26/2001
• Status: Expired due to Fees

• Current Assignee: Nilimedix Ltd.
• Original Assignee: Nilimedix Ltd.
• Inventors: Shekalim, Avraham
• Primary Examiner(s): Lucchesi; Nicholas
• Assistant Examiner(s): Stigell; Theodore J.
• Application Number:
  US10/446,811
• Publication Number:
  US 20030216683A1
• Time in Patent Office: 1,622 Days
• Field of Search: 604 65- 67, 604131-135, 604/151, 604/152, 604/154, 604/505, 604/118, 604/890.1, 604/246, 417 26- 31, 417/38, 417/44.2, 137/14, 137/115.13
• US Class Current: 604/67
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626

Abstract

A drug delivery device includes a pressurized reservoir in communication with a flow path to an outlet. The flow path includes two normally-closed valves and a flow restriction. A pressure measurement arrangement measures a differential fluid pressure between two points along the flow path which span at least part of the flow restriction, one of the points being between the valves. A controller selectively opens the valves to deliver a defined quantity of the liquid medicament to the outlet.

Claims

1. A drug delivery device for metered delivery of a liquid medicament to an outlet, the device comprising:

(a) a pressurized reservoir configured for storing and supplying the liquid medicament at a pressure above atmospheric pressure;

(b) a flow path in fluid communication with said pressurized reservoir and the outlet, said flow path including;

(i) a first valve assuming a normally-closed flow-blocking state and selectively actuatable to an open state which permits fluid flow through said first valve,

(ii) a flow restriction configured to limit fluid flow along said flow path, and

(iii) a second valve assuming a normally-closed flow-blocking state and selectively actuatable to an open state which permits fluid flow through said second valve,

 

said first and second valves and said flow restriction being deployed such that, when both said first valve and second valve are in said open state, the liquid medicament flows from the pressurized reservoir along said flow path to the outlet at a rate limited primarily by said flow restriction, and such that, when any one of said first and second valves is in said flow-blocking state, flow through said flow restriction is blocked;

(c) a pressure measurement arrangement deployed in pressure-sensing engagement with a first point and a second point along said flow path, at least part of said flow restriction being between said first and second points, one of said first and second points being intermediate to said first and second valves; and

(d) a controller electronically associated with said pressure measurement arrangement and said first and second valves, and configured to selectively open said first and second valves to deliver a defined quantity of the liquid medicament to the outlet, said controller being further configured to;

(i) actuate said first and second valves such that said first and second valves close sequentially, thereby trapping a quantity of the liquid medicament between said first and second valves with a pressure differential across at least one of said first and second valves;

(ii) while said first and second valves are closed, monitor measurements of said pressure measurement arrangement; and

(iii) if said measurements vary so as to indicate a reduction in said pressure differential across said at least one valve, generate a malfunction indication.

2. The drug delivery device of claim 1, wherein said pressure measurement arrangement is configured to determine a differential pressure between fluid at said first and second points.

3. The drug delivery device of claim 1, wherein said controller is configured to determine based upon a differential pressure between said first and second points a current flow rate of liquid medicament through said at least part of said flow restriction.

4. The drug delivery device of claim 1, wherein said controller is configured to actuate pulsed opening of said first and second valves between said normally-closed state and said open state.

5. The drug delivery device of claim 1, wherein said controller is configured to:

(a) actuate both said first and second valves to assume said open state;

(b) compare a differential pressure between said first and second points to a minimum expected differential pressure value; and

(c) if said differential pressure is less than said minimum expected differential pressure value, generate a malfunction indication.

6. The drug delivery device of claim 1, wherein said pressurized reservoir includes an elastic pressurizing member such that a fluid pressure within said reservoir varies as a function of a volume of the liquid medicament currently stored, and wherein said controller is configured to:

(a) estimate a remaining volume of the liquid medicament in said reservoir based upon at least one measurement from said pressure measurement arrangement obtained under zero flow conditions; and

(b) if said remaining volume is less than a minimum volume value, generate a low-remaining-volume indication.

7. The drug delivery device of claim 1, wherein said controller is configured to:

(a) during operation of the drug delivery device, repeatedly;

(i) selectively actuate one of said first and second valves to said open state such that said pressure measurement arrangement measures a value of a differential fluid pressure under zero flow conditions between said reservoir and the outlet, and

(ii) store said differential fluid pressure values;

(b) monitor said stored values to identify an increase in said values relative to a mean peak pressure difference; and

(c) if an increase in said values is identified, generate a disconnection indication.

8. The drug delivery device of claim 1, wherein said pressurized reservoir is configured to deliver the liquid medicament at a pressure in excess of four atmospheres.

9. The drug delivery device of claim 1, further comprising a reservoir pressure release mechanism associated with said controller and selectively actuatable to depressurize said reservoir so as to deactivate delivery of the liquid medicament to the outlet.

10. The drug delivery device of claim 1, wherein the device includes a body and a removable cartridge, wherein said pressurized reservoir and said flow path are implemented as part of said removable cartridge, and wherein said controller is implemented as part of said body.

11. The drug delivery device of claim 10, wherein said first and second valves are implemented as part of said replaceable cartridge, each of said valves having an actuator sufface isolated from said fluid flow path, said valve being configured such that force applied to said actuator surface actuates said valve to assume said open state, and wherein said body includes at least one electrically operated actuator deployed for selectively applying a force to at least one of said actuator surfaces.

12. The drug delivery device of claim 11, wherein said actuator includes:

(a) at least one piezoelectric element electrically actuatable to generate a first displacement; and

(b) a mechanical amplifier mechanically cooperating with said piezoelectric element such that said first displacement of said piezoelectric element generates a second displacement of said actuator surface, said second displacement being greater than said first displacement.

13. The drug delivery device of claim 10, wherein said pressure measurement arrangement includes a differential pressure sensor mounted included within said body, said differential pressure sensor being in fluid connection with two connectors, and wherein said removable cartridge includes a pair of pressure sensing cells each separated from said flow path by a flexible membrane and each having a complementary connector, such that, when said removable cartridge is engaged with said body, each of said sensor connectors mates with a corresponding complementary connector such that said differential pressure sensor measures a differential pressure between liquid in said flow path at said first and second points.

14. The drug delivery device of claim 1, wherein said controller is configured to actuate said first and second valves such that said first and second valves close sequentially, thereby trapping a quantity of the liquid medicament between said first and second valves with a pressure differential across both of said first and second valves.

15. A method for identifying malfunction of at least one valve of a drug delivery device, the method comprising:

(a) providing a drug delivery device having a pressurized source of a liquid medicament supplying a flow path including two valves and a flow restriction;

(b) closing both valves in such a manner as to trap a quantity of the liquid medicament in a part of the flow path between the two valves with a pressure differential across at least one of the valves; and

(c) monitoring by use of a pressure measurement arrangement for a change in liquid pressure between the valves.

16. The method of claim 15, wherein said closing is performed in such a manner as to ensure a pressure differential across both of the valves, such that an increase in pressure between the two valves indicates leakage of a first of the valves and a decrease in pressure between the two valves indicates leakage of a second of the valves.

17. The method of claim 15, wherein said monitoring includes measuring a pressure differential between said pressurized source and liquid between the valves.

18. A method for delivery of a liquid medicament to an outlet the method comprising:

(a) providing a drug delivery device including;

(i) a pressurized reservoir storing and supplying the liquid medicament at a pressure above atmospheric pressure;

(ii) a flow path in fluid communication with said pressurized reservoir and the outlet, said flow path including two valves and a flow restriction, said two valves and said flow restriction being deployed such that, when any one of said two valves is closed, flow though said flow restriction is blocked;

(b) opening the two valves to allow flow from the reservoir through the flow restriction to the outlet;

(c) while the drug is flowing, measuring a fluid pressure differential across at least part of the flow restriction and deriving from the pressure differential a rate of fluid flow;

(d) closing at least one of the valves; and

(e) monitoring a differential fluid pressure between two points in the flow path while at least one of the valves is closed so as to identify at least one state of malfunction.

19. The method of claim 18, wherein said opening is implemented as pulsed opening of the two valves between a normally-closed state and an open state.

20. A drug delivery device for metered delivery of a liquid medicament to an outlet, the device comprising:

(a) a pressurized reservoir configured for storing and supplying the liquid medicament at a pressure above atmospheric pressure;

(b) a flow path in fluid communication with said pressurized reservoir and the outlet, said flow path including;

(i) a first valve assuming a normally-closed flow-blocking state and selectively actuatable to an open state which permits fluid flow through said first valve,

(ii) a flow restriction configured to limit fluid flow along said flow path, and

(iii) a second valve assuming a normally-closed flow-blocking state and selectively actuatable to an open state which permits fluid flow through said second valve,

 

said first and second valves and said flow restriction being deployed such that, when both said first valve and second valve are in said open state, the liquid medicament flows from the pressurized reservoir along said flow path to the outlet at a rate limited primarily by said flow restriction, and such that, when any one of said first and second valves is in said flow-blocking state, flow through said flow restriction is blocked;

(c) a pressure measurement arrangement deployed in pressure-sensing engagement with a first point and a second point along said flow path, at least part of said flow restriction being between said first and second points, one of said first and second points being intermediate to said first and second valves; and

(d) a controller electronically associated with said pressure measurement arrangement and said first and second valves, and configured to selectively open said first and second valves to deliver a defined quantity of the liquid medicament to the outlet,

wherein said pressurized reservoir includes an elastic pressurizing member such that a fluid pressure within said reservoir varies as a function of a volume of the liquid medicament currently stored, and wherein said controller is configured to;

(i) estimate a remaining volume of the liquid medicament in said reservoir based upon at least one measurement from said pressure measurement arrangement obtained under zero flow conditions; and

(ii) if said remaining volume is less than a minimum volume value, generate a low-remaining-volume indication.

21. A drug delivery device for metered delivery of a liquid medicament to an outlet, the device comprising:

(a) a pressurized reservoir configured for storing and supplying the liquid medicament at a pressure above atmospheric pressure;

(b) a flow path in fluid communication with said pressurized reservoir and the outlet, said flow path including;

(i) a first valve assuming a normally-closed flow-blocking state and selectively actuatable to an open state which permits fluid flow trough said first valve,

(ii) a flow restriction configured to limit fluid flow along said flow path, and

(iii) a second valve assuming a normally-closed flow-blocking state and selectively actuatable to an open state which permits fluid flow through said second valve,

 

said first and second valves and said flow restriction being deployed such that when both said first valve and second valve are in said open state, the liquid medicament flows from the pressurized reservoir along said flow pat to the outlet at a rate limited primarily by said flow restriction, and such that, when any one of said first and second valves is in said flow-blocking state, flow through said flow restriction is blocked;

(c) a pressure measurement arrangement deployed in pressure-sensing engagement with a first point and a second point along said flow path, at least part of said flow restriction being between said first and second points, one of said first and second points being intermediate to said first and second valves; and

(d) a controller electronically associated with said pressure measurement arrangement and said first and second valves, and configured to selectively open said first and second valves to deliver a defined quantity of the liquid medicament to the outlet, said controller being configured to;

(i) during operation of the drug delivery device, repeatedly;

(A) selectively actuate one of said first and second valves to said open state such that said pressure measurement arrangement measures a value of a differential fluid pressure under zero flow conditions between said reservoir and the outlet, and

(B) store said differential fluid pressure values;

(ii) monitor said stored values to identify an increase in said values relative to a mean peak pressure difference; and

(iii) if an increase in said values is identified, generate a disconnection indication.

22. A drug delivery device for metered delivery of a liquid medicament to an outlet, the device comprising:

(a) a pressurized reservoir configured for storing and supplying the liquid medicament at a pressure above atmospheric pressure;

(b) a flow path in fluid communication with said pressurized reservoir and the outlet, said flow path including;

(i) a first valve assuming a normally-closed flow-blocking state and selectively actuatable to an open state which permits fluid flow through said first valve,

(ii) a flow restriction configured to limit fluid flow along said flow path, and

(iii) a second valve assuming a normally-closed flow-blocking state and selectively actuatable to an open state which permits fluid flow through said second valve,

 

said first and second valves and said flow restriction being deployed such that, when both said first valve and second valve are in said open state, the liquid medicament flows from the pressurized reservoir along said flow path to the outlet at a rate limited primarily by said flow restriction, and such that, when any one of said first and second valves is in said flow-blocking state, flow through said flow restriction is blocked;

(c) a pressure measurement arrangement deployed in pressure-sensing engagement with a first point and a second point along said flow path, at least part of said flow restriction being between said first and second points, one of said first and second points being intermediate to said first and second valves;

(d) a controller electronically associated with said pressure measurement arrangement and said first and second valves, and configured to selectively open said first and second valves to deliver a defined quantity of the liquid medicament to the outlet; and

(e) a reservoir pressure release mechanism associated with said controller and selectively actuatable to depressurize said reservoir so as to deactivate delivery of the liquid medicament to the outlet.