Drug delivery cassette and a medical effector system

• US 7,935,081 B2
• Filed: 06/21/2005
• Issued: 05/03/2011
• Est. Priority Date: 08/31/2004
• Status: Expired due to Fees

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Donofrio, William T., Miller, Michael J., Krogh, Ross, Derouen, Jason P., Bishop, Gregory D., Keilholz, David J., Davis, DeWayne A., Eyster, Curt R., Wuennemann, Jeffery J., Flaker, Richard W., Katz, Hal H., Burdorff, Mark A., Nalagatla, Anil K., Niklewski, Paul J.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Eisenberg; Rebecca E
• Application Number:
  US11/158,262
• Publication Number:
  US 20060106345A1
• Time in Patent Office: 2,142 Days
• Field of Search: 604 65- 67, 604131-135, 604145-155
• US Class Current: 604/131
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/6819 Nose
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/7495 using a reader or scanner device, e.g. barcode scanner
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0493 with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
• CPC Class Codes: A61M 16/0672 Nasal cannula assemblies for oxygen therapy
• CPC Class Codes: A61M 16/0677 Gas-saving devices therefor
• CPC Class Codes: A61M 16/0688 by means of an adhesive
• CPC Class Codes: A61M 16/0808 Condensation traps
• CPC Class Codes: A61M 16/085 Gas sampling
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2021/0027 by the hearing sense
• CPC Class Codes: A61M 21/02 for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/048 : Anaesthetics
• CPC Class Codes: A61M 2202/062 : Desiccants
• CPC Class Codes: A61M 2205/05 : combined with other kinds of therapy
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/13 : with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/14 : Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/273 : preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/7536 : allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• CPC Class Codes: A61M 2210/0618 : Nose
• CPC Class Codes: A61M 2210/0625 : Mouth
• CPC Class Codes: A61M 2210/0662 : Ears
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• 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 5/162 : 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 5/16831 : 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: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

Disclosed is an interface between a drug delivery cassette and a medical effector system. The cassette may be mounted to the medical effector system in such a way that a fluid tube located on the cassette is positioned adjacent to a pump located on the medical effector system. The medical effector system may purge the fluid line of air by activating the pump and forcing fluid through the fluid line until a sensor positioned to monitor the fluid line indicates that fluid and not air is present in the tube. To prevent air purging of the fluid tube when connected to the patient, the medical effector system prohibits air purging unless the drug delivery end portion of the fluid tube is in a designated storage site located on the cassette. This is accomplished with a position sensor at the storage site that monitors the position of the fluid tube.

Claims

1. A drug-delivery infusion pump assembly and drug-delivery cassette assembly combination comprising:

a) a drug-delivery infusion pump housing;

b) a drug-delivery cassette assembly attachable to the infusion pump housing, having a tubing and a luer combination, and having a drug-delivery-cassette main board including a luer-site base portion, wherein the luer is attachable to and detachable from the luer-site base portion, and a tubing storage portion, wherein the tubing is releasably stored in a coiled state in the tubing storage portion;

c) a pump-housing door attached to the infusion pump housing and having door-open and door-closed positions; and

d) a pump-housing door lock which, when the cassette assembly is attached to the infusion pump housing and the pump-housing door is in the door-closed position, cannot unlock unless the luer is attached to the luer-site base portion.

2. The drug delivery infusion pump combination assembly of claim 1, wherein the lock includes a pump-door latch and a door latch solenoid operatively connected to the pump-door latch.

3. The combination assembly of claim 1, further comprising a pump, which controls flow of a drug in the tubing when the tubing is operatively connected to the pump and air purges the tubing prior to delivery of the drug through the tubing to the patient.

4. The combination assembly of claim 3, wherein the tubing is operatively disconnectable from the pump only when the luer is present in the luer-site base portion.

5. The combination assembly of claim 1, further comprising a sensor having an output and disposed to sense the presence and/or absence of the luer in the luer-site base portion.

6. The combination assembly of claim 5, wherein the pump-door housing lock cannot unlock unless the luer is stored in the luer-site base portion as determined from the output of the sensor.

7. The combination assembly of claim 1, wherein the drug-delivery cassette assembly comprises a drug-delivery-cassette main board, wherein a drug vial is attachable to the cassette main board, and wherein the cassette main board has a deflectable drug-vial-site sensor beam which is disposed to be deflected by the drug vial when the drug vial is attached to the cassette main board and to be undeflected when the drug vial is unattached to the cassette main board.

8. The combination assembly of claim 7, wherein the cassette main board is attachable to and detachable from a procedure room unit having a drug-vial-in-place optical sensor disposed to sense only one of the deflected drug-vial-site sensor beam and the undeflected drug-vial-site sensor beam.

9. The combination assembly of claim 8, wherein the procedure room unit controls flow of the drug from the drug vial based at least in part on the drug-vial-in-place optical sensor sensing or not sensing the drug-vial-site sensor beam.

10. The combination assembly of claim 8, wherein the drug-delivery-cassette main board is removably attachable to the procedure room unit of a medical effector system and which includes a peristaltic pump cutout.

11. The combination assembly of claim 8, wherein the drug-delivery-cassette main board comprises a top-left portion, a top-right portion, a bottom-right portion and a bottom-left portion, wherein the cassette main board is removably attachable to a procedure room unit of a medical effector system, wherein the main board has a peristaltic pump cutout disposed between the top-left and top-right portions, and wherein the main board has an air-in-line sensor cutout disposed between the top-right portion and the bottom-right portion.

12. The combination assembly of claim 11, also including a drug-delivery flexible tube having a substantially linear first portion attached to the top-left portion and the top-right portion of the main board and spanning the peristaltic pump cutout and having a substantially linear second portion attached to the top-right portion and the bottom-right portion of the main board and spanning the air-in-line sensor cutout, wherein, when the main board is attached to the procedure room unit, the first portion of the flexible tube is operatively connected to pump fingers of a drug-delivery peristaltic pump of the procedure room unit and the second portion of the flexible tube is operatively connected to an air-in-line sensor of the procedure room unit.

13. The combination assembly of claim 11, wherein the lower-left portion of the main board extends below the lower-right portion of the main board defining a pump-door-latch cutout extending to the right of the lower-left portion and below the lower-right portion of the main board.

14. The combination assembly of claim 7, wherein the drug vial includes a drug-vial seal, and wherein the drug-delivery cassette assembly also includes a spike having a spike tip and a spike barb, wherein, when the drug vial is attached to the cassette main board, the drug-vial seal is perforated by the spike tip and held by the spike barb and the drug-vial-site sensor beam pushes the drug vial up against the spike barb.

15. A drug-delivery infusion pump assembly and drug-delivery cassette assembly combination comprising:

a) a drug-delivery infusion pump housing;

b) a drug-delivery cassette assembly attachable to the infusion pump housing, comprising a tubing having a drug-delivery end portion and a drug-receiving end which is fluidly connectable to a drug vial containing a drug, wherein the drug-delivery end portion is attachable to and detachable from a storage site;

c) a pump-housing door attached to the infusion pump housing and having door-open and door-closed positions; and

d) a pump-housing door lock which, when the cassette assembly is attached to the infusion pump housing and the pump-housing door is in the door-closed position, cannot unlock unless the drug-delivery end portion is attached to the storage site.

16. The combination assembly of claim 15, wherein the tubing is releasably stored in a coiled state in a tubing storage portion.

17. The combination assembly of claim 15, further comprising a sensor having an output and disposed to sense the presence and/or absence of the drug-delivery end portion in the storage site.

18. The combination assembly of claim 17, wherein the pump-door housing lock cannot unlock unless the drug-delivery end portion is stored in the storage site as determined from the output of the sensor.