Patient-controlled drug administration device

• US 5,906,597 A
• Filed: 06/09/1998
• Issued: 05/25/1999
• Est. Priority Date: 06/09/1998
• Status: Expired due to Term

• Current Assignee: Avent Incorporated (Avanos Medical, Inc.)
• Original Assignee: I-Flow Corporation (Kimberly-Clark Corporation)
• Inventors: McPhee, Charles J.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US09/094,111
• Time in Patent Office: 350 Days
• Field of Search: 604/246, 604/245, 604/247, 604/249, 604/250, 604/256, 604/30, 604/31, 604/33, 604/34, 604/48, 604/65, 604/407, 604/132, 251/5
• US Class Current: 604/246
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 5/1424 Manually operated pumps

Abstract

A PCA device includes a fluid conduit having an upstream portion and a downstream portion, a first flow-restricting orifice in the upstream portion, a second flow-restricting orifice in the downstream portion, a pressure-responsive check valve in the downstream portion in parallel with the second flow-restricting orifice, and a bolus dose delivery mechanism including a chamber in fluid communication between the upstream portion and the downstream portion. Continuous flow is provided through the first flow-restricting orifice, the chamber, and the second flow-restrictive orifice, the continuous flow serving to fill the chamber at a controlled rate through the first flow-restrictive orifice. The bolus dose delivery mechanism is manually actuable to express the contents of the chamber through the check valve to supplement the continuous flow through the downstream portion. The bolus dose delivery mechanism includes a resilient diaphragm that forms a sealed closure for the chamber. The diaphragm is movable from a decompressed position to a compressed position by a plunger that directly engages the diaphragm, and it is restored to the decompressed position by the flow of fluid into the chamber.

Claims

1. A device for the administration of a liquid therapeutic agent to a patient, comprising:

a housing defining a fluid flow conduit having an upstream portion and a downstream portion;

chamber in the housing having an inlet lumen in fluid

communication with the upstream portion, and first and second outlet lumens separately in communication with the downstream portion;

a check valve in fluid communication with the second outlet lumen that is responsive to a predetermined cracking pressure to allow fluid flow from the second outlet lumen to the downstream portion; and

a resilient diaphragm disposed as a sealing closure for the chamber and movable between a compressed position when the chamber is voided of the agent and a decompressed position when the chamber is filled with the agent;

whereby the diaphragm is moved from the compressed position to the decompressed position by the force of the agent filling the chamber from the inlet lumen, during which filling some of the agent flows out of the chamber through the first outlet lumen; and

whereby the cracking pressure is created in the second outlet lumen in response to the movement of the diaphragm from the decompressed position to the compressed position, thereby allowing the agent to flow out of the chamber through the second outlet lumen.

2. The device of claim 1, wherein the agent flows from the inlet lumen through the chamber and through the first outlet lumen when the diaphragm is in the decompressed position, and the agent flows from the chamber through the second outlet lumen and the check valve only in response to the creation of the cracking pressure in the second outlet lumen.

3. The device of claim 1, further comprising:

a first flow-restricting orifice in the upstream portion; and

a second flow-restricting orifice in the first outlet lumen.

4. The device of claims 1, 2, or 3, wherein the check valve comprises:

a tubular element having an upstream end in fluid communication with the second outlet lumen and a downstream end in fluid communication with the downstream portion through a valve orifice; and

a flexible membrane secured to the tubular element so as to cover the valve orifice when the pressure in the second outlet lumen is less than the cracking pressure, whereby the membrane uncovers the valve orifice in response to the pressure in the second outlet lumen being at least equal to the cracking pressure.

5. The device of claims 1, 2, or 3, further comprising a plunger that is engageable against the diaphragm and that is manually movable from a first position to a second position to compress the diaphragm to express the agent from the chamber, and that is returned from the second position to the first position when the diaphragm is moved to the decompressed position as the chamber is filled with the agent.

6. The device of claim 4, further comprising a plunger that is engageable against the diaphragm and that is manually movable from a first position to a second position to compress the diaphragm to express the agent from the chamber, and that is returned from the second position to the first position when the diaphragm is moved to the decompressed position as the chamber is filled with the agent.

7. A device for the administration of a liquid therapeutic agent to a patient, comprising:

a housing defining a fluid flow conduit having an upstream portion and a downstream portion;

a chamber in the housing having an inlet lumen in fluid communication with the upstream portion, and first and second outlet lumens separately in communication with the downstream portion;

a check valve in fluid communication with the second outlet lumen that is responsive to a predetermined cracking pressure to allow fluid flow from the second outlet lumen to the downstream portion; and

a bolus dose delivery mechanism that is selectively actuable to (a) apply a pressure to the chamber that is at least equal to the cracking pressure to express a predetermined volume of the agent from the chamber through the second outlet lumen and the check valve, and (b) allow a refilling of the chamber with the agent through the first inlet lumen while also allowing a continuous flow of the agent from the chamber through the first outlet lumen.

8. The device of claim 7, wherein the bolus dose delivery mechanism comprises:

a resilient diaphragm disposed as a sealing closure for the chamber and movable between a compressed position when the chamber is voided of the agent and a decompressed position when the chamber is filled with the agent.

9. The device of claim 8, further comprising a plunger that is engageable against the diaphragm and that is manually movable from a first position to a second position to compress the diaphragm to express the agent from the chamber, and that is returned from the second position to the first position when the diaphragm is moved to the decompressed position as the chamber is filled with the agent.

10. The device of claim 8, wherein the agent flows from the inlet lumen through the chamber and through the first outlet lumen when the diaphragm is in the decompressed position, and the agent flows from the chamber through the second outlet lumen and the check valve only in response to the creation of the cracking pressure in the second outlet lumen.

11. The device of claims 7, 8, 9, or 10, further comprising:

a first flow-restricting orifice in the upstream portion; and

a second flow-restricting orifice in the first outlet lumen.

12. The device of claims 7, 8, 9, or 10, wherein the check valve comprises:

a tubular element having an upstream end in fluid communication with the second outlet lumen and a downstream end in fluid communication with the downstream portion through a valve orifice; and

a flexible membrane secured to the tubular element so as to close the valve orifice when the pressure in the second outlet lumen is less than the cracking pressure, whereby the membrane opens the valve orifice in response to the pressure in the second outlet lumen being at least equal to the cracking pressure.

13. The device of claim 11, wherein the check valve comprises:

a tubular element having an upstream end in fluid communication with the second outlet lumen and a downstream end in fluid communication with the downstream portion through a valve orifice; and

a flexible membrane secured to the tubular element so as to close the valve orifice when the pressure in the second outlet lumen is less than the cracking pressure, whereby the membrane opens the valve orifice in response to the pressure in the second outlet.

14. A system for the delivery of a liquid therapeutic agent to a patient, comprising:

a pressurized source for the agent; and

a patient-controllable delivery device having an upstream conduit portion in fluid communication with the source and a downstream conduit portion in fluid communication with a delivery conduit, the device comprising;

a chamber having an inlet lumen in fluid communication with the upstream portion, and first and second outlet lumens separately in communication with the downstream portion;

a check valve in fluid communication with the second outlet lumen that is responsive to a predetermined cracking pressure to allow fluid flow from the second outlet lumen to the downstream portion; and

a bolus dose delivery mechanism that is selectively actuable to (a) apply a pressure to the chamber that is at least equal to the cracking pressure to express a predetermined volume of the agent from the chamber through the second outlet lumen and the check valve, and (b) allow a refilling of the chamber with the agent through the first inlet lumen while also allowing a continuous flow of the agent from the chamber through the first outlet lumen.

15. The system of claim 14, wherein the bolus dose delivery mechanism comprises:

a resilient diaphragm disposed as a sealing closure for the chamber and movable between a compressed position when the chamber is voided of the agent and a decompressed position when the chamber is filled with the agent.

16. The system of claim 15, wherein the agent flows from the inlet lumen through the chamber and through the first outlet lumen when the diaphragm is in the decompressed state, and the agent flows from the chamber through the second outlet lumen and the check valve only in response to the creation of the cracking pressure in the second outlet lumen.

17. The device of claim 14, further comprising a plunger that is engageable against the diaphragm and that is manually movable from a first position to a second position to compress the diaphragm to express the agent from the chamber, and that is returned from the second position to the first position when the diaphragm is moved to the decompressed position as the chamber is filled with the agent.

18. The system of claims 14, 15, or 16, further comprising:

a first flow-restricting orifice in the upstream portion; and

a second flow-restricting orifice in the first outlet lumen.

19. The device of claim 17, wherein the check valve comprises:

a tubular element having an upstream end in fluid communication with the second outlet lumen and a downstream end in fluid communication with the downstream portion through a valve orifice; and

a flexible membrane secured to the tubular element so as to close the valve orifice when the pressure in the second outlet lumen is less than the cracking pressure, whereby the membrane opens the valve orifice in response to the pressure in the second outlet lumen being at least equal to the cracking pressure.

20. The system of claims 14, 15, or 16, wherein the check valve comprises:

a tubular element having an upstream end in fluid communication with the second outlet lumen and a downstream end in fluid communication with the downstream portion through a valve orifice; and

a flexible membrane secured to the tubular element so as to close the valve orifice when the pressure in the second outlet lumen is less than the cracking pressure, whereby the membrane opens the valve orifice in response to the pressure in the second outlet lumen being at least equal to the cracking pressure.