Systems and methods to monitor proper disinfection of needleless connectors

• US 9,216,440 B2
• Filed: 05/29/2013
• Issued: 12/22/2015
• Est. Priority Date: 05/31/2012
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ma, Yiping, Isaacson, S. Ray
• Primary Examiner(s): CONLEY, SEAN EVERETT
• Application Number:
  US13/904,285
• Publication Number:
  US 20130323117A1
• Time in Patent Office: 937 Days
• Field of Search: 422/119
• US Class Current: 1/1
• CPC Class Codes: A61L 2/16 using chemical substances
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: A61L 2202/17 Combination with washing or cleaning means
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: A61M 39/162 with antiseptic agent incorporated within the connector
• CPC Class Codes: B08B 1/143 Wipes
• CPC Class Codes: B08B 1/32 using rotary cleaning members
• CPC Class Codes: B08B 3/08 the liquid having chemical or dissolving effect substances used, see the relevant classes
• CPC Class Codes: G06K 7/10009 sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A device and method for disinfecting a needleless connector, the device including a housing comprising a hub rotationally coupled to a motor, the motor being operably connected to a power source, the hub further comprising a receptacle configured to receive a cleaning head, wherein the device is configured to detect achievement of one or more minimum thresholds which are recommended to achieve proper disinfection of the needleless connector. Various devices and methods are further provided to permit tracking and reporting of disinfection events.

Claims

1. A device for disinfecting a needleless connector, the device comprising:

a housing comprising a hub rotationally coupled to a motor, the motor being operably connected to a power source, the hub further comprising a receptacle configured to receive a cleaning head, the cleaning head having a distal opening into which is inserted a needleless connector to allow the cleaning head to disinfect the needleless connector when the cleaning head is rotated by the motor; and

a pressure-sensitive switch for controlling the motor, the pressure-sensitive switch being positioned proximal to the cleaning head such that proximal movement of the cleaning head activates the motor, the pressure-sensitive switch being configured to require that the needleless connector be inserted into the cleaning head with at least a threshold amount of force to cause the cleaning head to move sufficiently in the proximal direction to activate the pressure-sensitive switch thereby ensuring that the at least a threshold amount of force is applied by the cleaning head on the needleless connector during rotation of the cleaning head.

2. The device of claim 1, further comprising a timer to monitor the duration of disinfection.

3. The device of claim 2, further comprising a disinfection status indicator operably connected to the timer.

4. The device of claim 3, wherein the disinfection status indicator is configured to identify when the duration of disinfection has reached a threshold duration.

5. The device of claim 1, wherein the cleaning head comprises an absorbent and compressible material that lines the distal opening and a separate pad that lines the absorbent material.

6. The device of claim 1, wherein the cleaning head comprises a plurality of indents formed on an outer surface of the cleaning head, and the hub includes a corresponding plurality of hook members that pivot within the receptacle to selectively couple with the indents thereby retaining the cleaning head within the receptacle.

7. The device of claim 1, further comprising an input device for receiving an identification of at least one of the needleless connector, the cleaning head, and the patient.

8. The device of claim 7, further comprising an output for communicating the identification of at least one of the needleless connector, the cleaning head, and the patient.

9. The device of claim 8, wherein the output comprises at least one of a wireless antenna, an electrical connector, an RFID transmitter, and a Bluetooth transmitter.

10. The device of claim 7, wherein the input device comprises at least one of a barcode scanner, an optical camera, a magnetic card reader, and a RFID reader.

11. The device of claim 1, wherein the needleless connector further comprises a computer readable code that identifies at least one of the needleless connector and a patient, and wherein the computer readable code is at least one a barcode, a QR code, an RFID chip, and a magnetic stripe.

12. The device of claim 8, further comprising a network operably connected to the output.

13. The device of claim 12, further comprising an electronic medical record operably connected to the output via the network.

14. The device of claim 7, further comprising memory whereby to store the identification and the disinfection status of the needleless connector.

15. The device of claim 6, wherein the hub includes an ejector at a proximal end of the receptacle, the ejector configured to extend distally within the receptacle to apply a distal force against the cleaning head thereby causing the hook members to decouple from the indents and ejecting the cleaning head from the receptacle.

16. A device for disinfecting a needleless connector, the device comprising:

a housing containing a motor and a shaft that is rotated by the motor;

a hub that is coupled to the shaft, the hub having a receptacle formed in a distal end of the hub, the hub including a plurality of hook members positioned within the receptacle;

a cleaning head having a proximal portion that inserts into the receptacle of the hub, an outer surface of the cleaning head including a plurality of indents into which the plurality of hook members insert to selectively couple the cleaning head within the receptacle of the hub such that the cleaning head is rotated when the hub is rotated, the cleaning head also having a distal opening configured to receive a needleless connector to allow the cleaning head to disinfect the needleless connector when the cleaning head is rotated by the motor.

17. The device of claim 16, wherein the hub includes an ejector at a proximal end of the receptacle, the ejector configured to extend distally within the receptacle to apply a distal force against the cleaning head thereby causing the hook members to decouple from the indents and ejecting the cleaning head from the receptacle.

18. The device of claim 16, further comprising:

a pressure-sensitive switch for controlling the motor, the pressure-sensitive switch being positioned proximal to the cleaning head such that proximal movement of the cleaning head activates the motor, the pressure-sensitive switch being configured to require that the needleless connector be inserted into the cleaning head with at least a threshold amount of force to cause the cleaning head to move sufficiently in the proximal direction to activate the pressure-sensitive switch thereby ensuring that the at least a threshold amount of force is applied by the cleaning head on the needleless connector during rotation of the cleaning head.

19. The device of claim 16, further comprising:

a sensor to monitor a current of the motor as an indication that an amount of force applied by the cleaning head on the needleless connector exceeds a threshold; and

one or more indicators to notify a user when the amount of force does not exceed the threshold.