Patient controlled infusion apparatus and method

• US 5,084,021 A
• Filed: 11/02/1990
• Issued: 01/28/1992
• Est. Priority Date: 11/02/1990
• Status: Expired due to Term

• Current Assignee: BAXA Corporation (Baxter International Inc.)
• Original Assignee: BAXA Corporation (Baxter International Inc.)
• Inventors: Baldwin, Brian E.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US07/608,283
• Time in Patent Office: 452 Days
• Field of Search: 604/131, 604/134, 604/135, 604/137, 604/138, 604/207, 604/236, 604/246
• US Class Current: 604/131
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 5/1424 Manually operated pumps

Abstract

Patient controlled analgesic (PCA) infusion apparatus and method are disclosed, in which a liquid desired to be self-infused into a patient is controllably supplied from a positively pressurized supply reservoir to a lower pressure dose chamber of a patient operable syringe from which the patient may expel the liquid and infuse such into a suitable infusion site, as through a cannula inserted into the patient, the supply of liquid from the reservoir to the dose chamber being controlled by a flow control metering tube assembly, including a connecting tube with a flow-restricting metering rod disposed therein and of a selected effective length such that the combined flow impedance of the flow path formed by the overall flow metering tube and rod provide a selected flow rate for a reference fluid and reference pressure differential. The flow control metering tube assembly may be suitably constructed by empirical testing and sizing of individual flow control tube/rod assemblies to achieve a desired flow impedance. A suction, preferrably forming a vacuum-induced void, is automatically effected in the dose chamber by a return spring acting on a piston forming a rear wall of the dose chamber, after each infusion by the patient, so as to effect a desired selected substantially constant refill flow rate of liquid from the supply reservoir and into the dose chamber. A check valve is provided in an outlet tube to enable patient actuated infusion outflow of liquid from the dose chamber while opposing reverse inflow back into the dose chamber, and thus aiding in enabling a desired suction vacuum induced void to be created within the dose chamber during the dose chamber refill operation as a function of fast rearward spring acting return movement of a piston forming the movable rear wall of the dose chamber.

Claims

1. Patient controllable fluid infusion apparatus comprising a fluid flow metering tube connecting set for attachment between a fluid source under pressure and a use site, which fluid flow metering tube connecting set comprises

a flexible metering connecting tube having connector means at its opposite inlet and outlet ends,

said connecting and metering tube having a central bore which forms a first fluid flow impedance as a function of the cross-sectional size of said bore,

a flow restricting rod having a flow-blocking cross sectional construction with an outer cross sectional size smaller than the cross sectional size of said bore,

said rod being disposed within and extending along a selected longitudinal extent of said bore, to thereby form an effective fluid flow passageway bore cross section of reduced cross-sectional size around the outside of and along the longitudinal extent of said rod within said tube bore, which longitudinal extent of reduced cross-sectional size forms a second fluid flow impedance as a function of the longitudinal extent and cross-sectional size of said reduced cross-sectional size effective fluid flow passage way bore along the length of said rod within said bore,

a fluid delivery syringe having a fillable fluid chamber from which fluid may be expelled by patient action,

a fluid supply reservoir for enabling filling of said chamber, said fluid supply reservoir being connected to said inlet end of said metering connecting tube,

and said outlet end of said metering connecting tube being connected in fluid supply relation to said syringe chamber,

said fluid delivery syringe having a fluid outlet therefrom for patient controlled dispensing of fluid from its said chamber to a selected site after flow of fluid from said fluid source through said metering connecting tube and around said flow restricting rod as a function of and while maintaining a substantially constant pressure differential between said fluid source and said chamber.

2. Patient controllable fluid infusion apparatus according to claim 1, further comprising

a flexible outlet tube in fluid outflow connection with said fluid outlet, and means connected to the outlet end of said outlet tube for fluid flow connection of said outlet tube in fluid flow relation to a patient infusion site.

3. Patient controllable fluid infusion apparatus according to claim 1,

in which fluid flow is enabled into said syringe chamber from said fluid source in response to suction within said syringe chamber and further comprising

unidirectional valve means enabling unidirectional outflow from said syringe chamber while effectively preventing reverse flow from said selected site back to said chamber.

4. Patient controllable fluid infusion apparatus according to claim 1, said syringe comprising

a barrel having a patient controlled piston slidably disposed within said barrel and forming the movable rear end of said chamber,

and spring means effective to move said piston rearwardly to quickly enlarge said chamber and thereby create a vacuum within said chamber which enables metered fluid flow at a rate which is a function of the differential pressure between said fluid source and said syringe chamber and the fluid flow impedance of said rod-restricted flexible metering connecting tube.

5. Patient controllable fluid infusion apparatus according to claim 2,

the pressure of said fluid source being substantially ambient atmospheric pressure.

6. Patient controllable fluid infusion apparatus according to claim 2,

the pressure of said fluid source being greater than ambient atmospheric pressure.

7. Patient controllable fluid infusion apparatus according to claim 1, further comprising

visual indicator means for indicating the fluid content status of said fluid source.

8. Patient controllable fluid infusion apparatus according to claim 1,

said reservoir comprising a movable container wall onto which ambient atmospheric pressure is applied.

9. Patient controllable fluid infusion apparatus according to claim 1, said fluid reservoir comprising

a syringe having a barrel within which said reservoir is formed,

and a fluid sealing piston slidable within said barrel and forming a movable wall of said reservoir as a function of the pressure differential on opposite outer and inner faces of said piston.

29. The method according to claim 1,

in which said rod and said fluid passageway are of effectively substantially constant cross-sectional size along said selected length of said fluid passageway.

30. The method according to claim 1,

wherein said pump has a piston forming a movable wall of said fluid storage chamber and being forwardly movable by patient action to expel fluid from said chamber,

and resiliently biasing said piston rearwardly with a force sufficient to create a vacuum within said chamber for effecting fluid flow from said source and through said flexible fluid passageway having said rod therein and into said fillable fluid storage chamber, which resilient biasing force is sufficiently small to enable ease of patient actuation of said piston for expelling of fluid after fluid charging of said chamber from said source in response to rearward chamber-vacuum-creating movement of said piston.

31. The method according to claim 1,

and selecting said rod extent extending within said tubular passageway to be a length relative to said tubular passageway diameter such that said rod is effectively self-restrained against movement by the flow of fluid therepast.

32. The method according to claim 1,

said maintaining of substantially constant pressure differential comprising the step of effecting substantially constant vacuum within said fluid dose storage chamber, while maintaining a substantially constant positive absolute pressure on fluid medication within said fluid source.

33. The method according to claim 32,

in which said substantially constant positive absolute pressure on fluid medication within said fluid source is effected by subjecting said fluid medication to ambient atmospheric pressure.

34. The method according to claim 1,

said rod being maintained along said selected longitudinal extent of said passageway by securing a fixed length said rod within said passageway.

35. The method according to claim 34,

in which said rod is maintained along said selected longitudinal extent of said passageway by securing one end of said rod within said passageway.

10. Patient controllable fluid infusion apparatus comprising

a fluid flow metering tube connecting set for attachment between

a fluid source under pressure and a use site, which flow metering tube connecting set comprises

a flexible metering connecting and tube having connector means at its opposite inlet and outlet ends,

said metering connecting and tube having a central bore which forms a first fluid flow impedance as a function of the cross-sectional size of said bore,

a flow restricting rod having a fluid flow blocking cross sectional construction and an outer cross sectional size smaller than the cross sectional size of said bore,

said rod being disposed within and extending along a selected length of said bore, to thereby form an effective fluid flow passageway bore cross section of reduced cross-sectional size along the longitudinal extent of said rod length within said bore, which longitudinal extent of cross-sectional size forms a second fluid flow impedance as a function of the longitudinal extent and cross-sectional size of said reduced effective fluid flow passageway bore along the length of said rod within said bore,

a fluid delivery pump having fillable fluid chamber from which fluid may be expelled by patient action,

a fluid supply reservoir for enabling filling of said chamber,

said fluid supply reservoir being connected to said inlet end of said metering connecting tube, and said outlet end of said metering connecting tube being connected in fluid supply relation to said syringe chamber,

said fluid delivery pump having fluid outlet therefrom for patient controlled dispensing of fluid from its said chamber to a selected site after flow of fluid from said fluid source through said metering connecting tube as a function of and while maintaining a substantially constant pressure differential between said fluid source and said chamber.

11. Patient controllable fluid infusion apparatus according to claim 10, further comprising

a flexible outlet tube in fluid outflow connection with said fluid outlet, and means connected to the outlet end of said outlet tube for fluid flow connection of said outlet tube in fluid flow relation to a patient infusion site.

12. Patient controllable fluid infusion apparatus according to claim 10,

in which metered restricted fluid flow is enabled into said syringe chamber from said fluid source in response to suction within said syringe chamber,

and further comprising check valve means enabling unidirectional fluid outflow from said syringe chamber while effectively preventing reverse flow from said selected site back to said chamber.

13. Patient controllable fluid infusion apparatus according to claim 10, said syringe comprising

a barrel having a patient controlled piston slidably disposed within said barrel and forming the movable rear end of said chamber,

and spring means effective to move said piston rearwardly to quickly enlarge said chamber and thereby create a vacuum within said chamber which enables metered fluid flow at a rate which is a function of the differential pressure between said fluid source and said syringe chamber and the fluid flow impedance of the rod-restricted said flexible metering connecting tube.

14. Patient controllable fluid infusion apparatus according to claim 12,

the pressure of said fluid source being substantially ambient atmospheric pressure.

15. Patient controllable fluid infusion apparatus according to claim 12,

the pressure of said fluid source being greater than ambient atmospheric pressure.

16. Patient controllable fluid infusion apparatus according to claim 10,

said reservoir comprising a movable container wall.

17. Patient controllable fluid infusion apparatus according to claim 10,

said fluid reservoir comprising

a syringe having a barrel within which said reservoir is formed,

and a fluid sealing piston slidable within said barrel and forming a movable wall of said reservoir as a function of pressure differential on opposite outer and inner faces of said piston.

18. Patient controlled infusion apparatus, comprising

a syringe having a barrel forming a fluid chamber bounded by a fluid sealing rear piston slidable forwardly by a patient to expel fluid from said chamber,

spring means biasing said piston rearwardly,

fluid inlet and outlet means enabling filling of said chamber with fluid and expelling of fluid from said chamber,

fluid reservoir means maintained at a substantially constant pressure and connectable in fluid supply relation with said fluid inlet means for supply of fluid to said chamber,

a flexible fluid flow metering tube connected in restricted fluid flow relation between said fluid reservoir and said fluid inlet means,

said fluid flow metering tube having a fluid flow bore and a flow-restricting rod having a flow-blocking cross-sectional construction and disposed within said bore and having a selected length,

said rod being smaller in cross section than the corresponding cross section of said bore along said selected length, to thereby form a rod-restricted effective fluid flow passageway of lesser cross-sectional area than said bore alone along said rod extending within said bore, which lesser cross-sectional area passageway forms a second greater fluid flow impedance as compared to the fluid flow impedance of said bore without said rod therein, for enabling desired metering of fluid passing between said reservoir and said syringe chamber in response to rearward return movement of said piston by said spring after forward manual movement thereof, and as a function of the length and cross-sectional area of said lesser cross-sectional area fluid passageway,

means for connection of said syringe fluid outlet means to a patient fluid infusion site for patient controlled expulsion and application of fluid medication to said infusion site through manual forward movement of said piston against the action of said spring,

and check valve means connected in fluid flow relation with said fluid outlet means permitting outflow of fluid from said fluid chamber and preventing return of expelled fluid through said fluid outlet means to said chamber.

19. Patient controlled infusion apparatus according to claim 18,

said flow-restricting rod being flexible for flexing as a function of flexing of said flexible fluid flow metering tube in the zone of said rod extent therewithin.

20. Patient controlled infusion apparatus according to claim 18, further comprising

means for restraining longitudinal movement of said rod within said bore due to forward fluid flow through said bore and past said rod.

21. Patient controlled infusion apparatus according to claim 18, said selected length of said flow restricting rod within said bore being of an extent relative to the diameter of said rod such that said rod is effectively self-restrained against longitudinal movement within said bore.

22. Patient controlled infusion apparatus according to claim 21,

said rod being of a length at least approximately 300 times the diameter of said rod.

23. Patient controlled infusion apparatus according to claim 18,

said rod being anchored within said bore.

24. Patient controlled infusion apparatus according to claim 18,

said rod being anchored within said bore at one end of said rod.

25. Patient controlled infusion apparatus according to claim 18,

said rod having a wider and thinner securing segment formed thereon, which segment is in securing engagement with the bore wall of said tube.

26. Patient controlled infusion apparatus according to claim 18,

said rod having a deformed end segment which has a cross section engagable in retentive relation at two spaced positions with the bore wall of said tube, while being spaced from said bore wall between said spaced positions.

27. Patient controlled infusion apparatus according to claim 26

said deformed end segment being wider than the inner diameter of said tube bore and thinner than the undeformed cross-sectional size of said rod.

28. The method of controlled intermittent infusion of fluid to a patient infusion site, comprising

metering control of fluid flow from a fluid source to a pump having a fillable fluid dose storage chamber and which is patient-actuatable to pump fluid medication from said fluid storage chamber to a patient infusion site, said metering control comprising

passing fluid from a substantially constant pressure fluid source through a flexible tubular passageway to said fillable fluid dose storage chamber while maintaining a substantially constant pressure differential between said fluid source and said fillable fluid dose storage chamber,

and selectively restricting fluid flow through said tubular passageway by disposing a flow-restricting rod having a flow-blocking cross-section therewithin along a selected longitudinal extent of said passageway, which rod is smaller in cross sectional area than the longitudinally corresponding said tubular passageway along said selected length of said rod,

selectively intermittently actuating said pump to expel fluid from said chamber,

and administering said expelled fluid to a patient infusion site.