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EP-4245324-B1 - HAND-HELD STERILE CONNECTION DEVICE, SYSTEM, AND METHOD OF USE

EP4245324B1EP 4245324 B1EP4245324 B1EP 4245324B1EP-4245324-B1

Inventors

  • MADSEN, JAMES
  • WEGENER, CHRISTOPHER J.

Dates

Publication Date
20260506
Application Date
20230310

Claims (14)

  1. A hand-held sterilization device (10) comprising: a sterilization chamber (12) defined by a base unit (14) and a lid (16); a first moveable holder (26) and a second moveable holder (26) within said sterilization chamber (12), wherein the first moveable holder and the second moveable holder are configured to hold tubing connectors (22a, 22b); a handle (18) supporting said sterilization chamber (12); a light source (28) associated with said sterilization chamber (12); and an actuator (20) configured to cause movement of said first and second moveable holders (26).
  2. The sterilization device of Claim 1, wherein the lid is attached to the base unit and wherein the lid (16) comprises slots (24) configured to receive tubing extending from the tubing connectors (22a, 22b) when the lid is in a closed position.
  3. The sterilization device of any one of Claims 1-2 wherein the first and second holders (26) are moveable towards each other.
  4. The sterilization device of Claim 3, wherein the first and second holder (26) are moveable towards each other to a first position for sterilization of the tubing connectors and a second position to open a fluid pathway between the tubing connectors (22a, 22b).
  5. The sterilization device of any one of Claims 1-4, wherein the first holder and the second holder (26) comprise a groove (29) configured to receive the tubing connectors (22a, 22b).
  6. The sterilization device of any one of Claims 4-5, wherein the actuator (20) is a trigger on said handle (18), wherein said trigger is movable to a first position for moving said first and second holders into the holder first position and a second position for moving the first and second holders into a second position.
  7. The sterilization device of any one of Claims 4-5, wherein said actuator (20) is a button on the handle (18), said button being configured to move the first and second holders into the first position when said button is pressed a first time and to move the first and second holders into the second position when said button is pressed a second time.
  8. The sterilization device of any one of Claims 4-5, wherein said actuator (20) comprises a first and second button on the handle (18), said first button being configured to move the first and second holders to the first position and said second button being configured to move the first and second holders into the second position.
  9. A system for providing a sterile fluid pathway connection comprising: a first reusable tube connector (22a) configured to receive a first tube and a second reusable tube connector (22b) configured to receive a second tube; and a hand-held sterilization device (10) according to any of the preceding claims.
  10. The system of Claim 9, wherein the first reusable tube connector is configured to receive the second reusable tube connector to provide a fluid pathway connection.
  11. The system of any one of Claims 9-10, wherein said first moveable holder and second moveable holder are moveable towards each other.
  12. The system of Claim 11, wherein the actuator is moveable to a first position to move the first and second holders to a first position and to a second position to open a fluid pathway.
  13. A method for transferring fluid in a sterile manner comprising: attaching an open first end of a tube to a first tube connector (22a) wherein said tube includes a second end in flow communication with a source of fluid; attaching an open first end of a second tube to a second tube connector (22b); locating said first and second connectors (22a, 22b) within a sterilization chamber (12) carried by a handle (18) of a hand-held device as defined in any of the claims 1-8, wherein said chamber (12) receives light from a light source (28) associated with said device; placing the first tube connector (22a) into a first holder (26) and the second tube connector (22b) into a second holder (26) within the sterilization chamber (12); temporarily joining said first and second connectors (22a and 22b) to establish a flow path between said first and second tubes; exposing at least said flow path to a sterilizing light from said light source (28) for a selected period of time; opening the flow path and flowing fluid from said source of fluid through said flow path; and separating said first and second connectors.
  14. The method of Claim 13, further comprising moving an actuator (20) to a first position to establish to establish an air-tight seal between the first connector and second connector and moving said actuator to a second position to open the flow path.

Description

Field of the Disclosure The present disclosure is directed to a hand-held sterilization device, system, and a method for transferring fluid in a sterile manner. More particularly, the present disclosure is directed to a hand-held sterilization device and system, and a method for creating temporary sterile fluid flow path connections. Background Fluid flow processing systems or assemblies for transferring or dispensing a fluid (liquid) from a source container to one or more receiving containers or receptacles are used in a variety of medical and non-medical applications. In the medical field, in particular, the transfer of fluid must be carried out in a sterile manner, i.e., without exposing the fluids or the open ends of the tubing that carries the fluid to the outside environment. One example of this is the collection of multiple samples from a large volume of a collected biological fluid. Currently, sterile connections are typically made by joining the ends of connecting tubing associated with a respective part of a processing system, for instance, by cutting, then melting the tubes together creating a fluid pathway, and then sterilizing the pathway. One example of a device that creates a sterile connection is the TSCD-II sterile tubing welder, available from Terumo Medical Corporation. This device uses a heated cutting element to sever and melt the ends of tubing using a heated wafer, which are joined together after the cutting element is removed. The heated wafer creates an aseptic connection. Aspects of this device are disclosed in U.S. Patent Application Publication No. 2020/0047423. One disadvantage of welding devices and the traditional methods of making a sterile connection is that such a connection cannot be easily undone as the tubes are physically and permanently bonded. For example, where a fluid from a single source container must be dispensed to multiple (smaller volume) containers or receptacles, each transfer from the source container would require severing the first connection between the source container to the receiving containers, followed by the (re)establishing a new sterile connection between the source and the next receiving container. This sequence of creating a sterile connection, transferring fluid, severing the connection, and re-establishing a sterile connection with the next receiving container is time-consuming, inefficient, and wasteful. Furthermore, currently available tubing welding devices are benchtop devices that require connections to be made wherever the device is located and not necessarily where the transfer of fluid is to occur. Large, benchtop models are not well suited to be moved from place to place. While there are handheld sterilization devices are known, they mostly are only applicable for sterilizing a single end of a tube or catheter. WO 2018/013581 A1 refers to a handheld and portable disinfection device for use with patients having indwelling catheters hospitalized or in an intensive care unit. WO 2010/036617 A1 refers to a portable photodynamic disinfection light deliver device for catheter disinfection US 2015/258230 A1 refers to a UV-C catheter hub sterilization and data acquisition system. EP 2854873 B1 refers to a UV disinfection system. Thus, it would be desirable to provide a device which can easily and repeatedly establish a sterile fluid pathway without the successive cutting, heating and physical connecting of plastic tubes. It would also be desirable to provide a portable device that can establish the sterile connection where the fluid transfer is to occur (rather than transport a fluid processing set to a stationary sterile connection device). The device disclosed herein addresses these and other needs. Summary There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto. In one aspect, a hand-held sterilization device is disclosed. The hand-held sterilization device includes a sterilization chamber defined by a base and a lid and at least one holder within the sterilization chamber. The device includes a handle supporting the sterilization chamber, a light source associated with the sterilization chamber, and an actuator configured to move the at least one holder. In another aspect, a system for providing a sterile fluid pathway connection is disclosed. The system includes a first reusable tube connector configured to receive a first tube and a second reusable tube connector configured to receive a second tube and a hand-held sterilization device. The sterilization device of the system includes a sterilization chambe