Infusion pump with a sealed drive mechanism and improved method of occlusion detection

• US 6,423,035 B1
• Filed: 06/18/1999
• Issued: 07/23/2002
• Est. Priority Date: 06/18/1999
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Animas Corporation (Johnson & Johnson)
• Inventors: Shipway, Ian Maxwell, Das, Kusal K.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): HAN, MARK K
• Application Number:
  US09/335,999
• Time in Patent Office: 1,131 Days
• Field of Search: 604/131, 604/154, 604/155, 604/118, 604/151, 604/156, 128/DIG.12, 128/DIG.1
• US Class Current: 604/155
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• 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: Y10S 128/01 Motorized syringe
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A piston-type infusion pump is provided having an improved method of occlusion detection. The infusion pump includes processing circuitry for controlling the drive mechanism to infuse medication to a patient, including a sensor to track the position of the syringe plunger, thereby metering the amount of medication dispensed to the patient. The processing circuitry also includes a force sensor for providing signals indicative of the presence of occlusions along the infusion path. The operation of the drive mechanism causes delivery of medication to the patient. The infusion pump is constructed to be watertight.

Claims

1. An infusion pump for dispensing volumetrically proportioned doses of pharmaceutical product to a subject by way of an infusion path, the infusion path being adapted to connect the pump intravenously or subcutaneously to the subject, the pump including a power source, motor and processor, the processor selectively controlling the motor to dispense the volumetrically proportioned doses of pharmaceutical product along the infusion path, the infusion pump comprising:

a housing;

a pharmaceutical storage area formed in the interior of the housing, said storage area including a first aperture formed in a wall of the housing;

a pump door connected to said housing for accessing the storage area of said housing, the pump door including a second aperture for accessing said first aperture through said pump door;

a latch movable between a first position and a second position for securing the pump door to the housing in said second position, the latch including a stem extending into the housing along a latching axis, the stem including a lever section rotating upon movement of the latch between said first and second positions;

a pharmaceutical cartridge for containing a supply of medication, said cartridge having a dispensing tip and a plunger, said plunger provided to urge the medication of the cartridge in the direction of the dispensing tip, the cartridge positioned in said storage area such that the dispensing tip is in registry with said first aperture for connection to the infusion path for dispensing pharmaceutical product thereto, said plunger extending along a drive axis, the drive axis being parallel to the latching axis;

a lead screw positioned along the drive axis, the lead screw operably linked to the motor and including a slide to operatively engage said plunger, the lead screw rotated by the motor when said motor is actuated by the processor; and

a pivotable drive nut positioned in operative relation to the lever section and for engaging the slide with the lead screw, the drive nut including a tab portion for engaging said lever section, whereby movement of the latch to the second position to secure the pump door to the housing upon installation of the cartridge rotates the lever section to move said drive nut to threadedly engage the lead screw, and upon rotation of the lead screw the drive nut is moved against the slide to incrementally urge the plunger for dispensing volumetrically proportioned doses of medication along the infusion path.

2. The infusion pump of claim 1 wherein the lead screw has a buttress thread.

3. The infusion pump of claim 1 wherein the housing is watertight.

4. The infusion pump of claim 1 wherein the plunger is U-shaped and surrounds a half circumference of the lead screw.

5. The infusion pump of claim 1 further comprising a linear position sensor for providing a signal to the processor to determine the position of the drive nut along the drive axis.

6. The infusion pump of claim 5 wherein a linear sensor detection surface is parallel to and spans the entire length of the lead screw.

7. The infusion pump of claim 6 further comprising an LED light source mounted to the slide for providing input to the linear position sensor whereby the sensor signal provided to the processor determines the remaining medication in the cartridge.

8. The infusion pump of claim 1 wherein the pivotable drive nut includes an over center spring assembly such that the movement of the latch from the first position to the second position releases the lever section from against the tab portion of said drive nut to pivot said drive nut to an opposing side of the spring assembly for threadedly engaging the lead screw.

9. The infusion pump of claim 1 further comprising an elastomeric seal affixed to the wall of the housing about the periphery of the first aperture to provide a water tight seal between the cartridge and said housing.

10. The infusion pump of claim 1 further comprising a keypad operably linked to the processor for programming the operation of said processor to adjust the basal rate of the medication infusion.

11. The infusion pump of claim 1 further comprising an LCD display having a longitudinally formatted menu for programming and accessing pump status information.

12. The infusion pump of claim 11 wherein the amount of medication remaining in the cartridge is included in the status information.

13. The infusion pump in accordance with claim 1 wherein the infusion pump includes a menu driven graphic display, the data in said display being displayed in portrait format.

14. An infusion pump for dispensing volumetrically proportioned doses of pharmaceutical product to a subject by way of an infusion path, the infusion path being adapted to connect the pump intravenously or subcutaneously to the subject, the pump including a power source, motor and processor, the processor selectively engaging the motor to dispense the volumetrically proportioned doses of pharmaceutical product along the infusion path, the infusion pump comprising:

a watertight housing;

a cartridge port formed in the interior of the housing, said port including a first aperture formed in a wall of the housing, said first aperture including an elastomeric seal about the periphery interior to the housing;

a pump door connected to said housing wall for accessing the cartridge port of said housing, the pump door including a second aperture for accessing said first aperture through said pump door;

a latch movable between a first position and a second position for securing the pump door to the housing in said second position, the latch including a stem extending into the housing along a latching axis, the stem including a lever section rotating upon movement of the latch between said first and second positions;

a pharmaceutical cartridge for containing a supply of medication, said cartridge having a dispensing tip and a plunger, said plunger provided to urge the medication of the cartridge in the direction of the dispensing tip, the cartridge positioned in the cartridge port such that the dispensing tip is in registry with said first aperture creating a watertight seal about the periphery of the first aperture, said plunger extending along a drive axis, the drive axis being parallel to the latching axis;

a lead screw positioned along the drive axis, the lead screw operably linked to the motor and a slide to engage said plunger, the lead screw rotated by said motor when said motor is actuated by the processor; and

a pivotable drive nut positioned in operative relation to the lever section and along the drive axis of the latch stem, the drive nut including a tab portion for engaging said lever section, whereby movement of the latch to the second position to secure the pump door to the housing upon installation of the cartridge rotates the latch stem lever section to pivot said drive nut to threadedly engage the lead screw, and upon rotation of the lead screw, the drive nut is moved against the slide to incrementally urge the plunger for dispensing volumetrically proportioned doses of medication along the infusion path.

15. An infusion pump for dispensing volumetrically proportioned doses of pharmaceutical product to a subject by way of an infusion path, the infusion path being adapted to connect the pump intravenously or subcutaneously to the subject, the pump including a power source, motor and processor, the processor selectively controlling the motor to dispense the volumetrically proportioned doses of pharmaceutical product along the infusion path, the infusion pump comprising:

a pharmaceutical cartridge for containing a supply of medication, said cartridge having a dispensing tip and a plunger, said plunger provided to urge the medication of the cartridge in the direction of the dispensing tip, said plunger extending along a drive axis;

a linear sensor positioned within the infusion pump and having a detection surface parallel to the drive axis, said linear sensor being operably linked to the processor for providing a position signal to the processor;

a lead screw positioned along the drive axis, the lead screw operably linked to the motor and including a slide to engage said plunger, the lead screw rotated by the motor when said motor is actuated by the processor to move the slide against the plunger to incrementally urge the plunger for dispensing volumetrically proportioned doses of medication along the infusion path; and

an LED mounted on the slide to provide light to the linear sensor detection surface for producing said position signal whereby the position of the slide on the lead screw is determined by the processor to gauge the remaining medication in the cartridge.

16. An infusion pump comprising:

a housing, including a storage area formed in the interior of the housing, and a first aperture formed in a wall of the housing, the storage area and the housing being adapted to receive a syringe containing medication;

a pump door connected to the housing for accessing the storage area of the housing, the pump door including a second aperture which aligns with the first aperture when the pump door is closed providing access to the storage area;

a latch mounted on the housing moveable between a first position and a second position for securing the pump door to the housing in the second position, the latch having a stem extending into the housing along a latching axis, the stem including a rotatable lever section which rotates upon movement of the latch between the first and second positions;

a lead screw positioned along a drive axis within the storage area;

a motor operably linked to the lead screw to rotate the lead screw;

circuitry connected to the motor for controlling operation of the motor;

a slide adapted to operatively engage a plunger rod of a syringe when inserted into the storage area, the plunger rod being positioned along the drive axis and extending into the storage area; and

a pivotable drive nut mounted on the slide for engaging the lead screw, the drive nut positioned in operative relation to the lever section, the drive nut including a tab portion for engaging the lever section, whereby movement of the latch to the second position to secure the pump door to the housing, rotates the lever section thereby permitting the drive nut to threadedly engage the lead screw, and wherein upon rotation of the lead screw the slide engages the plunger rod to incrementally urge the plunger rod to dispense volumetrically proportioned doses of medication along an infusion path.

17. The infusion pump of claim 16 wherein the lead screw has a buttress thread.

18. The infusion pump of claim 16 wherein the housing is substantially watertight when the syringe is inserted into the storage area.

19. The infusion pump of claim 16 wherein the lead screw is positioned such that it resides in a cavity formed by the plunger rod when the syringe is inserted into the storage area.

20. The infusion pump of claim 16 wherein the plunger rod is substantially U-shaped.

21. The infusion pump of claim 16 further comprising a linear position sensor mounted on a wall of the housing for determining the position of the slide along the drive axis, the linear position sensor including a linear detection surface parallel to the lead screw for receiving input to the linear position sensor.

22. The infusion pump of claim 21 further comprising an LED light source mounted to the slide for providing input to the linear position sensor.

23. The infusion pump of claim 16 wherein the medication delivered along the infusion path is insulin.

24. The infusion pump of claim 16 further comprising a spring assembly connected to the drive nut and slide, wherein movement of the latch from the first position to the second position disengages the lever section from the tab portion of the drive nut, and wherein the lever section pivots the drive nut to threadedly engage the lead screw.

25. The infusion pump of claim 16 further comprising a seal affixed to the wall of the housing about the periphery of the first aperture to provide a substantially water tight seal between the syringe inserted into the storage area and the housing.

26. The infusion pump of claim 16 further comprising a keypad operably linked to the circuitry for programming and controlling the operation of the infusion pump.

27. The infusion pump of claim 16 wherein the circuitry includes a processor.

28. The infusion pump of claim 16 further comprising an LCD display.

29. The infusion pump of claim 28 wherein the LCD display indicates the amount of medication remaining in the storage area.

30. The infusion pump of claim 16 wherein the circuitry further detects occlusion and/or leakage within the infusion pump and/or infusion path.

31. The infusion pump of claim 16 further comprising an occlusion detector for detecting an occlusion within the infusion pump and/or the infusion path, the occlusion detector including a force transducer, detection circuitry and a processor.

32. The infusion pump of claim 16 further comprising a leakage detector for detecting a leak within the infusion pump and/or the infusion path, the leakage detector including a force transducer, detection circuitry and a processor.