METHOD AND APPARATUS FOR PREVENTING THE USE OF UNAUTHORIZED DISPOSABLE SETS IN INFUSION PUMPS

• US 20090204075A1
• Filed: 02/08/2008
• Published: 08/13/2009
• Est. Priority Date: 02/08/2008
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Simpson, Peter C.
• Granted Patent: US 7,762,989 B2
• Time in Patent Office: Days
• US Class Current: 604/151
• CPC Class Codes: A61M 2039/1094 at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 39/287 Wedge formed by a slot having varying width, e.g. slide clamps
• 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

Abstract

A system and method for automatically delivering an infusate to a patient is disclosed. The system includes an infusion set and an infusion device. A signaling component disposed on an infusion set component identifies the infusion set and is encrypted for security. The encryption may include both an encryption algorithm and a valid number algorithm. A detection device operatively connected to the infusion device decrypts and detects the signaling component and identifies the infusion set. The infusion device is then configured to operate according to an administration protocol suitable for the infusion set and an infusion device, such as an infusion pump.

Claims

1. A slide clamp for use with an infusion device and an infusion set, comprising:

a body having an aperture adapted to receive an infusate tube connected to the infusion device; and

a signaling component encoded with a key that includes an encryption algorithm and a valid number algorithm, the signaling component configured to communicate information indicative of the infusion set to a detection device operatively connected to the infusion device.

2. The slide clamp of claim 1 wherein the signaling component is selected from the group consisting of an optical signaling component, an electrical signaling component, a radio frequency signaling component, a magnetic signaling component, a thermal signaling component, an ultrasonic signaling component, a mechanical signaling component, and combinations thereof.

3. The slide clamp of claim 1 wherein the signaling component is an optical signaling component selected from the group consisting of a bar code, a reflective material, a fluorescent material, a metal component, a color, a translucent material, printing, etching, ink, an ink printed code, ultraviolet pigment, infrared pigment, a heat marking, a laser mark, an arrangement of translucent areas, a protrusion extending from a slide clamp surface, an indentation disposed on a slide clamp surface, and combinations thereof.

4. The slide clamp of claim 1 wherein the signaling component is disposed at a location selected from the group consisting of on a surface of the body, within the body, on a lip of the slide clamp, in a lip of the slide clamp, and combinations thereof.

5. The slide clamp of claim 1 wherein the signaling component is affixed to a body surface by an attachment selected from the group consisting of a heat bond, an adhesive material, and a swaged attachment.

6. The side clamp of claim 1 wherein the signaling component further comprises a plurality of legs and the body surface further comprises a plurality of openings corresponding to the plurality of legs wherein each leg is inserted in a corresponding opening to secure the signaling component to the body.

7. The slide clamp of claim 1 wherein the detection device reads the signal component and generates a signal corresponding to the read signal component.

8. The slide clamp of claim 7 wherein the detection device sends the generated signal to one of the infusion device or a central server for decoding.

9. The slide clamp of claim 8 wherein the generated signal is decoded by the infusion device or the central server, and the infusion set is validated or rejected.

10. The slide clamp of claim 9 wherein decoding is accomplished using a decryption algorithm and a valid number algorithm.

11. The slide clamp of claim 7 wherein the detection device is part of the infusion device.

12. The slide clamp of claim 7 wherein the detection device is remotely located from the infusion set.

13. A system for delivering infusate to a patient, the system comprising:

an infusion device;

an infusion set;

a slide clamp corresponding to the infusion set;

a signaling component disposed on the clamp and encoded with a key, the signaling component identifying the infusion set; and

a detection device to read the signaling component and configured to generate a signal, wherein the key includes an encryption algorithm and a valid number algorithm.

14. The system of claim 13 wherein the infusion device is an infusion pump.

15. The system of claim 13 wherein the signaling component is selected from the group consisting of an optical signaling component, an electrical signaling component, a radio frequency signaling component, a magnetic signaling component, a thermal signaling component, an ultrasonic signaling component, a mechanical signaling component, and combinations thereof.

16. The system of claim 13 wherein the signaling component is an optical signaling component selected from the group consisting of a bar code, a reflective material, a fluorescent material, a metal component, a color, a translucent material, printing, etching, ink, an ink printed code, ultraviolet pigment, infrared pigment, a heat marking, a laser mark, an arrangement of translucent areas, a protrusion extending from a slide clamp surface, an indentation disposed on a slide clamp surface, and combinations thereof.

17. The system of claim 13 further comprising a controller to receive the signal and operatively connected to the infusion device, the controller adapted to configure the infusion device to operate according to an administration protocol.

18. The system of claim 13 wherein the detection device reads the signal component and generates a signal corresponding to the read signal component.

19. The system of claim 18 wherein the detection device sends the generated signal to one of the infusion device or a central server for decoding.

20. The system of claim 19 wherein the generated signal is decoded by the infusion device or the central server, and the infusion set is validated or rejected.

21. The system of claim 20 wherein decoding is accomplished using a decryption algorithm and a valid number algorithm.

22. The system of claim 18 wherein the detection device is part of the infusion device.

23. The system of claim 18 wherein the detection device is remotely located from the infusion set.

24. A method for delivering an infusate to a patient with an infusion set and an infusion device, the infusion set having a slide clamp component, the method comprising:

providing a signaling component on a component of the infusion set, the signaling component encoded with a key that includes an encryption algorithm and a valid number algorithm, the signal component configured with information indicative of the infusion set;

detecting the signaling component with a detection device and generating a signal;

decrypting and validating the signal, and determining the infusion set identified by the signaling component; and

operating the infusion device according to the infusion set.

25. The method of. claim 24 further comprising disposing the signaling component on the slide clamp component.

26. The method of claim 25 wherein the signaling component is one of an RFID tag or a bar code with an embedded code.

27. The method of claim 26 wherein the decryption and validation of the signal is performed at one of a central server or the infusion device.