Drug container entry mechanisms and method

• US 7,150,735 B2
• Filed: 05/16/2003
• Issued: 12/19/2006
• Est. Priority Date: 05/16/2002
• Status: Expired due to Fees

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Deak, Leslie R.
• Application Number:
  US10/439,327
• Publication Number:
  US 20030229330A1
• Time in Patent Office: 1,313 Days
• Field of Search: 604/6.05, 604/27, 604/28, 604/30, 604/43, 604/44, 604/83, 604 85- 88, 604151-155, 604/164.02, 604/506, 604/508, 604519-520, 604/181, 604/187, 604/188, 604/262, 604272- 74, 604/159, 604/403, 604/411, 604412-416, 604/163, 604/171, 604/164.08, 604/194, 210/252, 210/256, 210/257.1, 210/258, 210/198.1, 210/282, 417/477.2, 417/437, 417/439, 417/472, 417/474
• US Class Current: 604/411
• CPC Class Codes: A61M 2005/1623 Details of air intake
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3386 Low level detectors
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 39/281 Automatic tube cut-off devices, e.g. squeezing tube on detection of air
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The invention of this application relates generally to intravenous (IV) infusion of drugs to patients, and more particularly to aspects of an IV infusion system comprising an infusate cassette and an infusate container. The present invention provides a drug infusion cassette that incorporates a strong vial spike that may be non-metal, a means for sheathing the spike when it is not in use, an anti-free flow device, and other beneficial features such as an air entrainment lockout mechanism, quality assurance tags, stopcocks made of soft materials and means of securing tubing to the cassette with a minimum of individual parts. The drug cassette can be used with an automated spiking mechanism comprising a motorized vial holder that holds a vial. The spike remains sheathed if the drug cassette is not fully engaged with a mating surface of devices such as a pumping unit or a sedation and analgesia delivery system.

Claims

1. A cassette for use with an intravenous infusion apparatus including a pumping mechanism which administers an infusate to a patient, wherein said cassette is removably attachable to the intravenous infusion apparatus, and wherein said cassette comprises:

a drug container entry mechanism having an infusate flow umen configured such that infusate flows from the container and into the flow lumen;

a sheath for said entry mechanism, wherein said sheath is configured so that said drug container entry mechanism is not unsheathed until said cassette is safely engaged with a mating surface of said intravenous infusion apparatus;

a means for securing an infusate delivery conduit to the infusate flow lumen such that infusate can flow from the flow lumen into the delivery conduit;

a means for preventing flow of infusate from the flow lumen into the delivery conduit and into a patient in an uncontrolled manner; and

an indexing means for aligning the cassette when the cassette is attached to the intravenous infusion apparatus in a manner that allows proper administration of infusate to the patient.

2. The cassette of claim 1, wherein said drug container entry mechanism is a trocar assembly having a spike with a sharp tip configured for promoting puncturing and cutting of a membrane while minimizing lateral movement of said membrane'"'"'s fibers, said sharp tip including at least two cutting surfaces.

3. The cassette of claim 2, wherein said spike includes a cross-section and at least two bevels across portions of said cross-section such that the area of the cross section increases with increasing distance from the tip of said spike along the longitudinal centerline, the rate of change of the cross sectional area being minimized.

4. The cassette of claim 2, wherein said spike includes two lumens with the openings of said lumens located at or near said sharp tip.

5. The cassette of claim 4, wherein said spike is manufactured of plastic by injection molding.

6. The cassette of claim 4, wherein said spike has a cross-sectional shape that looks like a rectangle with equal semi-circles replacing two opposite sites of the rectangle and curved outward from the center of said rectangle.

7. The cassette of claim 6, wherein said cross-sectional shape includes three beveled surfaces.

8. The cassette of claim 6, wherein said spike includes a bevel across the entire cross-section at an angle between 70 degrees and 80 degrees from a plane extending perpendicular to the longitudinal centerline of said spike.

9. The cassette of claim 8, wherein the width of said cross-sectional shape is between 0.14 inches to 0.16 inches at the widest point.

10. The cassette of claim 8, wherein the thickness of said cross-sectional shape is between 0.06 inches to 0.08 inches.

11. The cassette of claim 6, wherein said spike includes two bevels extending down from a line spanning the cross-sectional thickness of said spike.

12. The cassette of claim 4, wherein said spike has a cross-sectional shape like a diamond.

13. The cassette of claim 12, wherein said diamond shaped cross-section includes three beveled surfaces.

14. The cassette of claim 4, wherein said spike has a cross-sectional shape that looks like a trapezoid with semi-circles of different diameters replacing two opposite sides of the trapezoid and curved outward from the center of said trapezoid.

15. The cassette of claim 4, wherein said spike has a cross-sectional shape like a stretched hexagon.

16. The cassette of claim 4, wherein said spike has a cross-sectional shape similar to that of a football.

17. The cassette of claim 4, wherein said spike has a semi-ogival cross-section.

18. The cassette of claim 1, wherein said sheath is operatively connected to said cassette and is configured for automatically covering said drug container entry mechanism upon detachment from said mating surface of said intravenous infusion apparatus.

19. The cassette of claim 1, wherein said intravenous infusion apparatus is a sedation and analgesia system.

20. A cassette for use with an intravenous infusion apparatus including a pumping mechanism which administers an infusate to a patient, wherein said cassette is removably attachable to the intravenous infusion apparatus, and wherein said cassette comprises:

a vial spike assembly comprising a spike for entering a drug container, at least one infusate flow lumen configured such that infusate flows from the container and into the flow lumen, an outlet connector to secure an infusate delivery conduit to the infusate flow lumen such that infusate can flow from the flow lumen into the delivery conduit, and a lever arm connected to a flow control valve to prevent flow of infusate through said infusate delivery conduit in an uncontrolled manner;

a sheath for said vial spike assembly having an interior surface and an exterior surface, wherein said sheath is configured so that said drug container entry mechanism remains sheathed until said cassette is safely engaged with a mating surface of said intravenous infusion apparatus; and

an indexing means for aligning the cassette when the cassette is attached to the intravenous infusion apparatus in a manner that allows proper administration of infusate to the patient.

21. The cassette of claim 20, wherein said sheath comprises one or more protuberances located on said interior surface to engage with said lever arm of said vial spike assembly to close and open said flow control means as said sheath moves to respectively cover and uncover said vial spike assembly.

22. The cassette of claim 21, wherein said sheath further comprises on said exterior surface mechanical means to engage a holder for said drug container and mechanical means to engage said sheath with said intravenous infusion apparatus.

23. The cassette of claim 20, wherein said vial spike assembly further comprises an air filter housing to house a filter element that filters out airborne disease organisms from the ambient air.

24. The cassette of claim 23, wherein said air filter housing includes an integrated air filter media holder.

25. A method for extracting from a vial infusate for use in an intravenous infusion apparatus comprising the steps of:

providing a cassette with a vial trocar assembly, said trocar assembly having a spike with an infusion flow lumen and a means to prevent infusate flow from said lumen, and a sheath, wherein said sheath is configured so that said spike is not unsheathed until said cassette is safely engaged with a matins surface of said intravenous infusion apparatus;

affixing said cassette to a drug pumping apparatus;

attaching a vial of infusate to said cassette such that said spike is simultaneously unsheathed and inserted into said vial and such that flow of infusate from said vial through said flow lumen and said delivery conduit is permitted;

initiating means to generate flow of infusate from said vial, through said flow lumen, into said delivery conduit; and

upon completion of infusate delivery, removing said vial such that said spike is simultaneously removed from said vial and sheathed and such that flow of infusate from said vial through said flow lumen and said delivery conduit is simultaneously disabled.

26. The method of claim 25, comprising the additional step of purging said infusion flow lumen and said infusion delivery conduit immediately following said step of attaching a vial.

27. The method of claim 25, comprising the additional step of securing said infusion delivery conduit against said intravenous infusion apparatus.

28. The method of claim 25, comprising the additional step of attaching a second vial of infusate.