System and method for drug preparation and delivery

• US 9,408,966 B2
• Filed: 08/05/2014
• Issued: 08/09/2016
• Est. Priority Date: 08/22/1997
• Status: Expired due to Fees

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Kamen, Dean
• Primary Examiner(s): Bouchelle, Laura
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US14/451,904
• Publication Number:
  US 20140343492A1
• Time in Patent Office: 735 Days
• Field of Search: 705 2- 4
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2206/22 eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• 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 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: F16K 5/0414 : Plug channel at 90 degrees to the inlet
• CPC Class Codes: F16K 5/0478 : on the plug

Abstract

A disposable cassette for mixing a drug in a vial includes a liquid inlet for connection to a liquid supply, a first vial spike, a second vial spike, a chamber and a valve mechanism. The chamber, the first and second vial spikes, and the liquid inlet are in fluid communication with each other. The valve mechanism may be actuated to control flow between the chamber, the vial receptacles and the liquid inlet.

Claims

1. A medical fluid delivery device configured to deliver fluid into a patient, comprising:

a pump configured to pump fluid;

a keypad configured to receive a dosage level;

an alarm configured to sound an alarm;

a control unit in operative communication with the pump, the keypad, and the alarm, wherein the control unit is configured to;

receive the dosage level from the keypad;

sound the alarm when the received dosage level is greater than a maximum dosage level;

override the maximum dosage level to deliver the received dosage level; and

control the pump to deliver the received dosage level.

2. The device according to claim 1, wherein the control unit is configured to determine if a medical provider has sufficient authority to override the maximum dosage prior to the control unit allowing the medical provider to override the maximum dosage level to deliver the received dosage level.

3. The device according to claim 1, wherein the keypad is configured to receive information regarding a desired drug delivery cycle for a given patient, wherein the information is enterable into the system and a drug is prepared and delivered according to the desired drug delivery cycle.

4. The device according to claim 1, wherein the control unit stores a safety framework.

5. The device according to claim 4, wherein the control unit is configured to sound the alarm if a drug delivery cycle entered into the keypad does not fall within the safety framework.

6. The device according to claim 1, wherein the control unit is configured to download safe dosage levels including the maximum dosage level via a network.

7. The device according to claim 1, wherein the control unit is configured to download patient information.

8. The device according to claim 7, wherein the patient information includes at least one drug allergy.

9. The device according to claim 1, wherein the keypad is configured to receive information regarding a desired drug delivery cycle, and wherein:

the information regarding the desired drug delivery cycle is enterable into the device, and

the control unit is configured to deliver a drug according the desired drug delivery cycle.

10. The device according to claim 1, wherein the control unit is configured to operatively receive a patient'"'"'s identification code.

11. The device according to claim 1, wherein the control unit is further configured to sound the alarm when at least one of a patient'"'"'s drug allergy and a patient'"'"'s low weight, as indicated by downloaded patient information, is determined to create an unsafe condition.

12. The system according to claim 11, wherein the unsafe condition is based on at least one of a drug to be delivered and a drug delivery cycle.

13. The device according to claim 1, wherein the control unit is configured to receive a list of dangerous drug interactions provided by a network.

14. The device according to claim 13, wherein the list of dangerous drugs is configured to be updatable by a pharmacy.

15. The device according to claim 13, wherein the control unit is configured to sound the alarm when an entered drug delivery corresponds to a dangerous drug interaction as indicated by the list of dangerous drug interactions.

16. The device according to claim 13, wherein the control unit is further configured to sound an alarm in response to a proposed drug delivery which the list of dangerous drug interactions indicates will cause a dangerous interaction if delivered.

17. The device according to claim 1, wherein the control unit is configured to record all drugs provided to the patient within a network.

18. The device according to claim 1, wherein the maximum dosage level is configured to be updateable by a pharmacy.

19. The device according to claim 1, wherein the control unit is configured to receive a safety framework from a network.

20. The device according to claim 19, wherein the control unit is configured to sound the alarm if a drug delivery cycle programmed into the control unit does not fall within the safety framework.

21. The device according to claim 1, wherein the control unit is configured to store information regarding a drug delivery to the patient and a time frame corresponding to the drug delivery.

22. The device according to claim 21, the control unit is configured to communicate the stored information with a network.

23. The device according to claim 22, wherein the network is configured to provide the stored information for later review by a medical provider and to communicate billing information regarding the stored information.

24. The device according to claim 23, wherein the billing information is configured for communication to the patient.

25. The device according to claim 23, wherein the billing information is configured for communication to an insurance company.

26. A medical fluid delivery device configured to deliver fluid into a patient, comprising:

a user interface configured to receive a dosage level;

an alarm configured to sound an alarm; and

a control unit configured to compare the dosage level received from the user interface and sound the alarm when the dosage level is above a predetermined threshold,

wherein;

the user interface is configured to receive an override, and

the control unit is configured to override the predetermined threshold if the override meets a predetermined criterion.

27. The device according to claim 26, wherein the predetermined criterion is sufficient authority.