Apparatus and method of intravenous fluid infusion

• US 6,641,562 B1
• Filed: 05/10/2000
• Issued: 11/04/2003
• Est. Priority Date: 05/10/2000
• Status: Expired due to Fees

• Current Assignee: HPS Medical Incorporated
• Original Assignee: HPS Medical Incorporated
• Inventors: Peterson, Dean McCormack
• Primary Examiner(s): Huson, Gregory L.
• Assistant Examiner(s): NGUYEN, TUAN N
• Application Number:
  US09/567,966
• Time in Patent Office: 1,273 Days
• Field of Search: 604/65-67, 604/131-133, 604/140, 604/141, 604/150, 604/151, 604/153, 604/246, 604/408-409
• US Class Current: 604/141
• CPC Class Codes: A61J 1/05 for collecting, storing or administering blood, plasma or medical fluids multiple bags systems for separating or storing blood components A61M1/0209; Infusion or perfusion containers
• CPC Class Codes: A61J 2200/70 Device provided with specific sensor or indicating means
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence

Abstract

An infusion system packaged in a light weight nylon portable mesh container, which is also the pump of the system, includes a removable therapy bag holding the Rx to be infused into the patient. A bladder within the pump is inflatable to provide pressure onto the therapy bag to aid in the discharge of the Rx. When filling the therapy bag, the pharmacist, using his computer to comply with standards, simultaneously programs an EPROM with data specifying the Rx as well as instructions for dispensing the Rx. In one embodiment of the invention, the EPROM fits into a docking receptacle in the pump, while in a second embodiment the EPROM is integral with the therapy bag. A microcomputer mounted in the pump is programmed to control the flow of the Rx to the patient, reading the data from the EPROM in generating the control signals. The microcomputer cyclically drives a fluid control module which outputs a fixed amount of Rx for each cycle of operation. Three fluid control modules are disclosed; a cavity which deliver a bolus of Rx for each rotor rotation, or a shuttling longitudinally displaceable “cork” positioned in the output connector of the therapy bag, or a squeezed tube. Flow is monitored, and alarm interrupts to the microcomputer are provided for flow failure generating appropriate alarms. An alarm shuts down system operation and alerts the patient by means of visual messages on the microcomputer display and by an audible alarm. A buffer memory in the pump stores data relevant to such a mishap for later examination to determine responsibility and cause. Data is tied to a real-time clock (date and time).

Claims

1. A therapy infusion apparatus for delivery of a therapeutic fluid to a patient, the apparatus comprising:

a) a flexible therapy bag,

b) a moveable surface comprising an inflatable bladder which can apply force to an outside surface of the therapy bag, wherein the inflatable bladder is inflatable by a fluid,

c) an exit port in said therapy bag comprising a memory unit storing information relating to at least one of identification of a patient and name of medication which therapy bag will allow fluid to exit in a delivery direction from said flexible therapy bag under pressure, and

d) an adjustable, fluid control element located along said delivery direction, after said exit port.

2. The therapy infusion apparatus of claim 1 wherein said therapy bag has at least one major face which comprises at least 25% of the total surface area of said therapy bag, and said movable surface can be moved into contact with said at least one major surface so that contact between said at least one major surface and said movable surface covers at least 50% of the surface area of said at least one major surface by the time that said movable surface is fully extended.

3. The therapy infusion apparatus of claim 1 wherein said therapy bag comprises at least two flow ports within a fluid control element, one of said ports comprising said exit port, and adjacent to at least one of said ports is a storage area for a memory unit and access ports for accessing information from said memory unit.

4. The therapy infusion apparatus of claim 3 wherein said memory unit comprises a chip, and the access ports enable electronic connection from an outside memory reading or memory writing apparatus to said chip.

5. The therapy infusion apparatus of claim 4 wherein the chip is present within said storage area, and said chip contains readable information relating to at least two different topics of information selected from the group consisting of a prescription for a therapeutic material;

the name of an active ingredient in the prescription;

the chemical name of a prescription carrier;

additives in the prescription;

volume of the prescription;

expiration date;

name of a prescribing doctor;

name of a local supplier or manufacturer of ingredients in the prescription;

source of at least some materials in the prescription;

a name of a therapy bag manufacturer;

a name of a pharmacist;

a patient name;

patient information relating to at least one of age, allergies, address, frequency of prescription refill, weight, and chemical intolerances;

instructions for a flow control module with respect to desired flow rates;

intervals for delivery;

rate and volume of delivery; and

drip rate.

6. The infusion apparatus of claim 1 wherein said fluid is a liquid, which moves said moveable surface of the bladder against a surface of the therapy bag.

7. The therapy infusion apparatus of claim 1 further comprising a microcomputer for controlling at least one operating function of said infusion apparatus.

8. The therapy infusion apparatus of claim 1 wherein said memory chip in said infusion therapy apparatus is programmable by an auxiliary computer external to said infusion apparatus, whereby information may be entered for storage in said memory chip relating to said therapeutic fluid.