Ambulatory patient infusion apparatus

• US 5,558,639 A
• Filed: 06/10/1993
• Issued: 09/24/1996
• Est. Priority Date: 06/10/1993
• Status: Expired due to Fees

• Current Assignee: David Stokes, Gangemi, Ronald J.
• Original Assignee: David Stokes, Gangemi, Ronald J.
• Inventors: Stokes, David, Gangemi, Ronald J.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US08/075,144
• Time in Patent Office: 1,202 Days
• Field of Search: 604/152, 604/67, 128/DIG. 12, 128/DIG. 13, 417/42, 417/43, 417/63, 417/360, 417/477.2, 222/52, 222/63, 222/309, 222/325, 222/333, 222/383.1
• US Class Current: 604/67
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A modular ambulatory patient infusion apparatus including a control module and an infusion fluid or solution-containing interlocking cassette. The control module includes thumbwheel presettable electronic circuitry and display means in the form of windows for viewing the preset numerical values. In accordance with these settings, the circuitry drives a motor-operated reciprocable piston actuator terminating in a finger-like flange engaging portion. The motor shaft drives a worm and worm gear arrangement for reciprocating the piston actuator, with each of the worm and worm gear interoperatively associated with light cells for determining both motor speed and worm gear revolution. These, in turn, provide signals to the circuitry to vary the duty cycle of a pulse width modulated motor controller, while providing an indication of a complete revolution of the worm gear (which correlates to one cycle of the piston actuator) and providing an indication of motor speed which is utilized to detect occlusions by motor speed slowdown or stall. A flexible solution bag is retained within the cassette with the discharge tube thereof in fluid communication with a fluid pumping means within a block having a chamber therein and valve arrangement therein. The fluid pump includes a piston communicating with the chamber and having a flanged end configured for coacting engagement with the finger-like flange engaging portion of the piston actuator of the control module. The valve arrangement includes first and second check valves in fluid flow communication with the chamber, the first valve being in flow communication with the tube from the bag and the second valve being in flow communication with a passage leading to an IV tube set for connection to the patient.

Claims

1. Infusion apparatus comprising:

a control module having motor means;

a cassette adapted for connection to said control module and having solution containing means therein, said cassette having a side thereof configured for matingly slidably engaging a side of said control module for connecting the two parts together as a unit;

a valve assembly within said cassette for controlling flow of solution from said solution containing means;

a piston member within said valve assembly, said piston member having a head protruding from said side of said cassette; and

reciprocable means within said control module protruding from said side thereof and reciprocated by said motor means, said reciprocable means and said head having coacting engaging configurations for enabling releasable attachment with said cassette positioned with its side in abutting relation with said side of said control module with said sides out of alignment, the sliding of one of said cassette and said module relative to the other both interlocking the two parts and engaging said head with said reciprocable means.

2. The apparatus of claim 1 wherein said control module includes a plurality of controls for setting solution discharge parameters and wherein said controls are positioned on said side of said control module for rendering the controls inaccessible with said cassette matingly engaging said control module.

3. The apparatus of claim 2 wherein said controls are thumbwheel switches which protrude slightly through slots in said side of said control module.

4. The apparatus of claim 1 wherein said control module includes microprocessor means electrically coupled to said motor for controlling the operation of the motor.

5. The apparatus of claim 4 wherein said reciprocable means is a piston actuator and said microprocessor means includes means for determining the time duration of the push stroke of said actuator and the pull stroke of said actuator and means for utilizing said time durations for determining operation of said apparatus.

6. The apparatus of claim 5 wherein said microprocessor means includes means for regularly periodically calculating the ratio between said time durations and for emitting an alarm in response to significant changes in the thus-calculated ratio over a number of successive calculated ratios.

7. The apparatus of claim 6 wherein said alarm is an occlusion alarm emitted in response to a significant increase in the time duration of the push stroke of said actuator relative to the time duration of the pull stroke of said actuator.

8. The apparatus of claim 4 wherein said reciprocable means is a piston actuator and wherein said microprocessor means includes means for monitoring actuation of said piston in both directions and determining values related to time of actuation in each direction.

9. The apparatus of claim 8 wherein the determined values relate to the time duration of actuation of said piston in each direction for providing an indication of the force acting against said piston by the solution and said microprocessor means issues an alarm in response to a significant change in values determined by said monitoring means.

10. The apparatus of claim 9 wherein said alarm is one of an occlusion alarm and an empty alarm.

11. The apparatus of claim 1 further including a tubing set connected in fluid flow relation with said valve assembly and wherein said head of said piston member protrudes a distance sufficient to enable manual grasping thereof with said control module separated from said cassette for enabling manual priming of said tubing set.

12. Fluid flow control apparatus comprising:

pump means having a reciprocable piston member in fluid flow communication with the fluid;

motor means;

means interconnecting said motor means and said piston member for reciprocating the same;

means in circuit relation with said motor means for setting desired fluid flow parameters;

means for determining the time duration of movement of said piston member in each direction of travel during operation of said motor means when pumping fluid; and

means responsive to the time durations thus determined for determining at least one state of said fluid flow parameters and for controlling said motor means in accordance with said desired fluid flow parameters.

13. The apparatus of claim 12 wherein said control means includes a microprocessor.

14. The apparatus of claim 12 wherein said fluid flow apparatus is an infusion apparatus and further includes tubing for transferring solution to a patient by means of said tubing and wherein said at least one state of fluid flow is an occlusion of fluid flow through said tubing.

15. The apparatus of claim 12 wherein said apparatus includes a control module and a separable cassette and wherein said motor means is contained in said control module and said reciprocable piston is contained in said cassette.

16. The apparatus of claim 15 wherein said cassette includes solution containing means and wherein said pump means includes a chamber in flow communication with first and second valve means within said cassette, said first valve means enabling flow of solution from said solution containing means into said chamber and said second valve means enabling flow of solution from said chamber to an intravenous tubing set.

17. The apparatus of claim 12 wherein said fluid flow apparatus is an infusion apparatus and further includes a solution bag and tubing for transferring solution to a patient from said solution bag by means of said tubing and wherein said at least one state of fluid flow is absence of solution in said bag.

18. The apparatus of claim 12 wherein said infusion apparatus includes a control module having a side with manually operable controls;

and a cassette having said piston member and a solution containing means therein with a side of said cassette configured for mating slidable engagement with said side of said control module for connecting the two parts together as a unit, the parts when thus connected together rendering said controls inaccessible, and wherein said interconnecting means is within said control module and includes a portion protruding from said control module side for engagement with and actuation of said reciprocable piston member.

19. The apparatus of claim 18 wherein said portion and said piston have coacting engaging configurations for enabling releasable attachment with said cassette positioned with its side in abutting relation with said side of said control module with said sides out of alignment, the sliding of one of said cassette and said module relative to the other both interlocking the two parts and engaging said portion with said reciprocable piston member.

20. Infusion apparatus comprising:

a control module having manually operable controls for setting solution discharge parameters, said module having a side with said manually operable controls on said side;

a separable cassette having solution containing means therein and a side thereof configured for mating engagement with said side of said control module for connecting the two parts together as a unit, the parts when thus connected together rendering said control means inaccessible; and

pumping means, part of which is contained in said control module and part of which is contained in said cassette, said pumping means enabling discharge of solution from said solution containing means in accordance with the setting of said controls, said part of said pumping means within said cassette including a chamber in flow communication with first and second valve means within said cassette, said first valve means enabling flow of solution from said solution containing means into said chamber and said second valve means enabling flow of solution from said chamber to an intravenous tubing set.

21. The apparatus of claim 20 wherein said pumping means includes a reciprocable piston within said chamber and said first valve means is actuable to an open condition on withdraw of said piston and said second valve means is normally closed during the drawing motion of the piston and opens in response to reverse movement of said piston.

22. The apparatus of claim 21 wherein said first and second valve means are each formed as one piece nipple-shaped valve members of elastic material of different durometers to thereby require a different force for actuation of each of said valve means.

23. The apparatus of claim 22 wherein said first valve member is formed of a lower durometer material than said second valve member.

24. The apparatus of claim 23 wherein said first valve member, at the outer end, has a deep single slit with low durometer material to provide minimal resistance, and said second valve member, at the outer end, has a shallow slit and is formed of a higher durometer material to eliminate possible seepage.

25. The apparatus of claim 22 wherein said part of said pumping means within said control module includes means for reciprocating said piston.

26. The apparatus of claim 25 wherein said means for reciprocating said piston includes reciprocable means within said control module protruding from said side thereof and motor means for actuation of said reciprocable means.

27. The apparatus if claim 21 further including microprocessor means for actuating said pumping means, said microprocessor means including means for monitoring actuation of said piston in both directions and determining values related to time of actuation in each direction.

28. The apparatus of claim 27 wherein said microprocessor means issues an alarm in response to a significant change in values determined by said monitoring means.

29. The apparatus of claim 28 wherein said alarm is one of an occlusion alarm and an empty alarm.

30. Fluid flow control apparatus comprising:

a control module;

a separable cassette including solution containing means;

pump means having a reciprocable piston member in fluid flow communication with the fluid, said reciprocable piston being contained in said cassette, and wherein said pump means includes a chamber in flow communication with first and second valve means within said cassette, said first valve means enabling flow of solution from said solution containing means into said chamber and said second valve means enabling flow of solution from said chamber to an intravenous tubing set, and wherein said reciprocable piston is within said chamber and said first valve means is actuable to an open condition on withdraw of said piston and said second valve means is normally closed during the drawing motion of the piston and opens in response to reverse movement of said piston;

motor means contained in said control module;

means interconnecting said motor means and said piston member for reciprocating the same;

means in circuit relation with said motor means for setting desired fluid flow parameters;

means for determining the time duration of movement of said piston member in each direction of travel during operation of said motor means when pumping fluid; and

means responsive to the time durations thus determined for determining at least one state of fluid flow and for controlling said motor means in accordance with said desired fluid flow parameters.

31. The apparatus of claim 30 wherein said first and second valve means are each formed as one piece nipple-shaped valve members of elastic material of different durometers.

32. The apparatus of claim 31 wherein said first valve member is formed of a lower durometer material than said second valve member.

33. The apparatus of claim 32 wherein said first valve member, at the outer end, has a deep single slit with low durometer material to provide minimal resistance, and said second valve member, at the outer end, has a shallow slit and is formed of a higher durometer material to eliminate possible seepage.