Pressure infusion pump

• US 5,954,696 A
• Filed: 12/15/1997
• Issued: 09/21/1999
• Est. Priority Date: 12/15/1997
• Status: Expired due to Fees

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Original Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Ryan, Timothy C.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US08/990,362
• Time in Patent Office: 645 Days
• Field of Search: 604/131, 604/140, 604/141, 128/DIG. 12
• US Class Current: 604/141
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A portable, ambulatory infusion pump for use with standard pre-filled infusion medicament containers is powered by a miniature compressed gas cylinder coupled to a mechanical pressure regulator which supplies regulated gas at a substantially constant pressure to an inflatable bladder. The bladder is positioned between a substantially rigid pressure surface and a moveable pressure transfer plate and pushes against the transfer plate when inflated. A pre-filled medicament container is positioned over the pressure transfer plate and is squeezed between the transfer plate and the pump housing cover as the plate is displaced in response to inflation of the flexible bladder. A safety interlock assembly is connected between the pressure regulator and the inflatable bladder and prevents inflation of the bladder unless the housing cover is completely closed. Upon inadvertent opening of the pump, the internal pressurization system is vented to atmosphere.

Claims

1. A portable, ambulatory infusion pump comprising:

a housing defining an interior volume, the housing having exterior dimensions so as to be held comfortably in a human hand, the housing further comprising;

a base;

a cover, configured to be slidably mounted on the base;

an end portion, the end portion including an access opening communicating with the interior volume, the access opening configured to receive an infusion set access spike therethrough;

a pressurization system, further comprising;

a replaceable, miniature compressed gas cylinder;

a mechanical pressure regulator coupled to the cylinder by a bushing;

a flexible inflatable bladder connected to receive pressure-regulated gas, whereby the bladder is pressurized upon introduction of pressure-regulated gas and volumetrically expands in response thereto;

a pressure member angularly disposed within the housing and having a substantially flat pressure surface;

a pivotally movable pressure plate, the flexible inflatable bladder disposed between the pressure surface and the pivotally movable pressure plate, the bladder expansion causing the movable pressure plate to rotatable displace in response thereto, the pressure surface and rotatably movable pressure plate defining an area therebetween sized to accept a standard, disposable pre-filled infusion medicament container; and

a safety interlock assembly, coupled between the pressure regulator and the inflatable bladder, the safety interlock assembly operatively responsive to the cover being completely mated to the housing base, the safety interlock assembly preventing introduction of the pressure-regulated gas to the bladder unless the cover is completely mated to the base.

2. The portable, ambulatory infusion pump according to claim 1, wherein the replaceable, miniature compressed gas cylinder is configured to contain from about 8 to about 20 grams of compressed gas at an internal cylinder pressure of from about 500 to about 1,000 psi.

3. The portable, ambulatory infusion pump according to claim 2, wherein the replaceable, miniature compressed gas cylinder is configured to contain about 16 grams of CO₂ gas at an internal at a nominal internal cylinder pressure of from about 800 to about 900 psi.

4. The portable, ambulatory infusion pump according to claim 3, wherein the mechanical pressure regulator is configured to regulate the cylinder pressure of the compressed gas and deliver the gas at a substantially constant outlet pressure in the range of from about 3 to about 25 psi to the flexible inflatable bladder.

5. The portable, ambulatory infusion pump according to claim 4, further comprising activation means for initiating an infusion, the activation means for preventing introduction of pressure-regulated gas to the bladder unless in an on condition, the activation means further for venting pressure-regulated gas from the bladder to the ambient atmosphere when in an off condition.

6. The portable, ambulatory infusion pump according to claim 5, wherein the activation means is a switch controlled two-way valve coupled between the mechanical pressure regulator and the safety interlock assembly.

7. The portable, ambulatory infusion pump according to claim 6, wherein the interlock safety assembly comprises a spring operated, piston controlled two-way valve, the valve including a protruding pin coupled to the piston, the pin engaged by an activation surface of the cover as the cover is slidably advanced to mate to the base.

8. A portable, ambulatory infusion system comprising:

a standard, disposable, flexible, pre-filled infusion medicament container including an outlet port adapted to be accessed by a standard infusion set port spike;

a re-useable, mechanical infusion pump for receiving the medicament container and for infusing medicament into a patient in a rate controlled fashion, the pump including;

a housing having exterior dimensions so as to enable the pump to be held comfortably in a human hand, the housing including an access opening configured to receive an infusion set port spike therethrough, the housing having a base, a cover and an end portion, in combination defining an interior volume;

a mechanical pressure regulator disposed in the housing;

a replaceable, miniature compressed gas cylinder coupled to the pressure regulator by a bushing, the regulator configured to provide gas at an outlet port at a substantially constant pressure;

a pressure member angularly disposed within the housing and having a substantially flat pressure surface;

a pivotably moveable pressure plate; and

a flexible inflatable bladder disposed over the pressure surface and underlying the moveable pressure plate, the bladder connected to receive pressure-regulated gas, whereby the bladder is pressurized upon introduction of pressure-regulated gas and volumetrically expands, the bladder expansion causing the pivotably movable pressure plate to rotatably displace in response thereto;

wherein, the medicament container is disposed between the pivotably moveable pressure plate and the housing cover, the bladder expansion causing a substantially constant pressure to be applied to the container by squeezing the container between the moveable pressure plate and the cover to thereby infuse the medicament into a patient at a substantially constant rate.

9. The portable, ambulatory infusion system according to claim 8, further comprising an infusion set, coupled to the medicament container, the infusion set including;

clear, flexible tubing defining a flow path;

a port spike disposed at one end of the flow path, the spike configured to access a spike port of a standard infusion medicament container;

a check valve disposed along a flow path;

an air elimination filter; and

a variable flow controlling resistive lumen, the lumen variably adjustable to define a selectable flow rate therethrough.

10. The portable, ambulatory infusion system according to claim 9, wherein the miniature compressed gas cylinder is configured to contain from about 8 to about 20 grams of compressed gas at an internal cylinder pressure of from about 500 to about 1,000 psi.

11. The portable, ambulatory infusion system according to claim 10, wherein the miniature compressed gas cylinder is configured to contain about 16 grams of compressed CO₂ gas at an internal cylinder pressure of from about 800 to about 900 psi.

12. The portable, ambulatory infusion system according to claim 11, wherein the mechanical pressure regulator is adapted to regulate the cylinder pressure of the compressed CO₂ gas and deliver the gas at a substantially constant outlet pressure in the range of from about 3 to about 25 psi.

13. The portable, ambulatory infusion system according to claim 12, further comprising:

activation means for initiating infusion, activation means for preventing introduction of pressure-regulated gas to the bladder unless in an on condition, the activation means further for venting pressure-regulated gas from the bladder to the ambient atmosphere when in an off condition; and

a safety interlock assembly, coupled between the pressure regulator and the inflatable bladder, the safety interlock assembly operatively responsive to the cover being completely mated to the housing base, the safety interlock assembly preventing introduction of pressure-regulated gas to the bladder unless the cover is completely mated to the base.

14. The portable, ambulatory infusion system according to claim 13, wherein the cover includes a viewing port, overlying the medicament container, the viewing port providing visual access to the medicament container so as to allow a patient to view the progress of infusion.

15. The portable, ambulatory infusion system according to claim 14, further including a mechanical pressurization indicator coupled to the pressure regulator, the indicator operatively responsive to the regulator'"'"'s outlet pressure, the indicator providing a pressurization indication so long as the regulator'"'"'s outlet pressure exceeds a minimum bladder inflation pressure.

16. A portable, ambulatory infusion system comprising:

a standard, disposable, flexible, pre-filled infusion medicament container including an outlet port adapted to be accessed by a standard infusion set port spike;

a re-useable, mechanical infusion pump for receiving the medicament container and for infusing medicament into a patient in a rate controlled fashion, the pump including;

a housing having exterior dimensions so as to enable the pump to be held comfortably in a human hand, the housing including an access opening configured to receive an infusion set port spike therethrough, the housing having a base, a cover and an end portion, in combination defining an interior volume;

a mechanical pressure regulator disposed in the housing;

a replaceable, miniature compressed gas cylinder coupled to the pressure regulator by a bushing, the regulator configured to provide gas at an outlet port at a substantially constant pressure;

a pressure member disposed within the housing and having a substantially flat pressure surface;

a moveable pressure plate;

a flexible inflatable bladder disposed over the pressure surface and underlying the moveable pressure plate, the bladder connected to receive pressure-regulated gas, whereby the bladder is pressurized upon introduction of pressure-regulated gas and volumetrically expands, the bladder expansion causing the movable pressure plate to displace in response thereto; and

a mechanical pressurization indicator coupled to the pressure regulator, the indicator providing a pressurization indication so long as the regulator'"'"'s outlet pressure exceeds a minimum bladder inflation pressure, wherein the pressurization indicator is a spring-operated pin, the spring having a spring constant such that the spring force is overcome by a gas pressure, whereby the gas pressure forces the pin against the spring allowing the pin to protrude outwardly in a manner so as to be visible by a patient;

wherein, the medicament container is disposed between the moveable pressure plate and the housing cover, the bladder expansion causing a substantially constant pressure to be applied to the container by squeezing the container between the moveable pressure plate and the cover to thereby infuse the medicament into a patient at a substantially constant rate.

17. The portable, ambulatory infusion system according to claim 16, wherein the cover includes fill state indicator means for gauging the progression of an infusion by indicating the volume capacity of an infusion container.

18. The portable, ambulatory infusion system according to claim 17, wherein the fill state indicator means comprises at least one clear viewing port disposed in the housing, the at least one viewing port positioned to allow observation of the rotational position of a back edge of the movable pressure plate.

19. The portable, ambulatory infusion system according to claim 18, wherein the housing includes spike capture means for securing the spike in the housing such that the spike cannot be inadvertently removed from the medicament container'"'"'s spike port, once the medicament container and spike are placed within the infusion system housing.