Medical device cap for drug transfer assembly

• US 11,446,479 B2
• Filed: 07/11/2019
• Issued: 09/20/2022
• Est. Priority Date: 09/29/2014
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Sathe, Tushar R.
• Primary Examiner(s): Medway, Scott J
• Assistant Examiner(s): Doubrava, John A
• Application Number:
  US16/508,874
• Publication Number:
  US 20190329019A1
• Time in Patent Office: 1,167 Days
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 39/162 with antiseptic agent incorporated within the connector
• CPC Class Codes: A61M 39/20 Closure caps or plugs for connectors or open ends of tubes

Abstract

A medical device cap that protectively surrounds a medical device component for disinfection purposes and includes an identification element that can record and transmit pertinent information of the medical device cap and the medical device component is disclosed. The medical device cap enables documentation of instances when the cap is used and promotes stronger compliance with the use of medical device caps for applications involving disinfection of a medical device component such as an IV access port or a luer tip. Use of the medical device cap results in better compliance and monitoring of the use of such caps and leads to reduced incidence of CRBSI infections related to medical device component contamination. In one embodiment, the medical device cap enables automated real-time electronic documentation of when the cap is applied, while also documenting duration of application and tracking of device for inventory management.

Claims

1. A medical device cap comprising:

a cap body removably connectable with a medical device; and

an identification element disposed on the cap body, wherein the identification element records and transmits information, wherein the identification element includes a radio-frequency identification (RFID) element, wherein the RFID element is configured to automatically record and transmit compliance information related to the medical device cap and/or the medical device upon connection of the medical device cap with the medical device, wherein the compliance information includes at least one of;

a time when the medical device cap is connected to the medical device, a frequency that the medical device cap is connected to the medical device, or any combination thereof, and wherein the RFID element is configured to automatically record and transmit the compliance information related to the medical device cap and/or the medical device upon removal of the medical device cap from the medical device.

2. The medical device cap of claim 1, wherein the cap body includes a cap exterior wall and a cap interior wall respectively corresponding to an exterior profile and an interior profile of the medical device cap, wherein the cap interior wall defines a cavity that is sized and shaped to receive the medical device.

3. The medical device cap of claim 1, wherein compliance information includes at least one of:

a time when the medical device cap is removed from the medical device, a duration of application to the medical device, a frequency that the medication device cap is connected to the medical device, or any combination thereof.

4. The medical device cap of claim 1, wherein the identification element includes a unique ID associated with the medical device cap.

5. The medical device cap of claim 1, wherein with the cap body connected to the medical device, the cap body protectively surrounds at least a portion of the medical device.

6. The medical device cap of claim 2, wherein the identification element is disposed on the cap exterior wall of the cap body.

7. The medical device cap of claim 2, further comprising a disinfecting sponge disposed within the cavity, wherein the disinfecting sponge includes cleaning and disinfecting agents that are released to contact the medical device when the medical device cap is connected to the medical device.

8. The medical device cap of claim 6, wherein the cap exterior wall includes a plurality of ribs extending around a periphery of the cap body.

9. A drug transfer assembly comprising:

an IV access port;

an intravenous line adapted for connection to a bloodstream of a patient, wherein the intravenous line includes a patient portion, a first portion, and a second portion;

a first connector connected to a first portion of the intravenous line;

a second connector connected to a second portion of the intravenous line;

an intravenous line connector connecting in fluid communication the patient portion of the intravenous line with the first portion of the intravenous line and the second portion of the intravenous line;

a patient connector disposed at a patient end of the patient portion of the intravenous line; and

a medical device cap removably connectable with the IV access port via the first connector, wherein the medical device cap includes an identification element, and wherein the identification element records and transmits information, wherein the identification element includes a radio-frequency identification (RFID) element, wherein the RFID element is configured to automatically record and transmit compliance information related to the medical device cap and/or the IV access port upon connection of the medical device cap with the IV access port, wherein the compliance information includes at least one of;

a time when the medical device cap is connected to the IV access port, a frequency that the medical device cap is connected to the IV access port, or any combination thereof, and wherein the RFID element is configured to automatically record and transmit the compliance information related to the medical device cap and/or the IV access port upon removal of the medical device cap from the IV access port.

10. The drug transfer assembly of claim 9, further comprising:

a clamp configured to temporarily restrict a flow of fluid within the intravenous line.

11. The drug transfer assembly of claim 9, further comprising:

an injector removably connectable with the IV access port via the first connector; and

a syringe assembly containing a medication.