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.
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, which is incorporated herein by reference.
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.
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.
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 chamber defined by a base and a lid. The chamber includes at least one holder, configured to receive one of the first or second reusable connectors. The hand-held sterilization 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 yet another aspect, a method for transferring fluid in a sterile manner is disclosed. The method includes attaching an open first end of a tube to a first tube connector wherein the tube includes a second end in flow communication with a source of fluid, and attaching an open first end of a second tube to a second tube connector. The first and second connectors are located within a sterilization chamber carried by a handle of a hand-held device, wherein the chamber receives light from a light source associated with the device. The method further includes temporarily joining the first and second connectors to establish a flow path between the first and second tubes, exposing at least the flow path to a sterilizing light from said light source for a selected period of time, opening the flow path and flowing fluid from said source of fluid through the flow path, and separating the first and second connectors.
A more detailed description of the systems and methods in accordance with the present disclosure is set forth below. It should be understood that the description below of specific devices and methods is intended to be exemplary, and not exhaustive of all possible variations or applications. Thus, the scope of the disclosure is not intended to be limiting and should be understood to encompass variations or embodiments that would occur to persons of ordinary skill.
Sterilization device 10 may be used to sterilize reusable connectors shown and described below. In general, the reusable connectors may be attached to tubing associated with two different parts of a fluid kit, circuit, or system. Using reusable connectors allows a user to make a temporary fluid connection between two tubes without physically welding the tubes together or otherwise making an irreversible permanent connection. Generally, the tubing and fluid kit associated with the respective tubing, including the pre-attached reusable connector, will be sterilized prior to making a connection.
The outer surfaces of reusable connectors may be, but are not limited to being, made of a transparent material. In one embodiment, the reusable connectors are made of a transparent material that can be penetrated by light from the sterilizing light source. In a more particular embodiment, the material may be transparent to at least UV-C light. In another embodiment, the reusable connectors may be made of a cyclic olefin copolymer (COC). Other transparent materials known in the art may be used without departing from the scope of the disclosure.
As further seen in
The footprint of lid 16 may correspond with the perimeter of the base 14. For instance, if the perimeter of the base 14 is a rectangular shape, the footprint of lid 16 will be a corresponding rectangular shape to cover the entirety of the base 14.
Lid 16 may include slots 24 in opposed side walls 16b and 16c configured to receive tubing when lid 16 is placed in its closed configuration.
As also shown in
The holders 26 may be configured to receive a reusable connector(s) 22a, 22b. In one embodiment, holders 26 may include slots such as U-shaped slots 29 for receiving collars 25, 27 (shown in
To establish a sterile flow path, holders 26 (with connectors mounted thereon) are moveable towards each other. Movement of holders 26 may be initiated by actuator 20 coupled to holders 26. In one embodiment, the actuator 20 may be a trigger. In another embodiment, the actuator 20 may be a button or a set of buttons. For example, by pressing actuator/trigger 20 to a first position, holders 26 may be moved towards one another to a first position, connecting the reusable connectors 22a, 22b above the light source 28. Again, by moving actuator 20 to a second position, the moveable holders 26 may be moved even closer to one another, opening a fluid pathway between the reusable connectors 22a, 22b.
The actuator 20 may be attached to the device 10 using a pin and hole system. For instance, the actuator 20 may contain a hole in the upper portion. A pin is then inserted through the hole to secure the actuator 20 to the handle 18. This allows the actuator 20 to rotate about the pin in the handle 18. Other methods of attaching the actuator 20 to the device may be used without departing from the scope of the disclosure.
In one embodiment, the actuator 20 is configured to move the holders 26 using a linkage system that will be known to those of skill in the art. For example, actuator 20 may turn a gear which engages two racks configured to move holders 26 closer together. In another embodiment, the actuator 20 may turn a cam which displaces internal stops to allow for linear springs to move the holders 26 towards one another. In yet another embodiment, the actuator 20 could drive two lead screws or roller screws together to move the holders 26 towards one another.
In another embodiment, the actuator 20 may be a button that sends a signal to a controller configured to move the holders 26. The controller may control motor driven movements within the device 10. In one instance, a single button may be used to move the holders 26. The button may be pressed a first time to send a first signal to the controller to move the holders 26 to a first position above the light source 28. Once the holders 26 are in the first position, the light source 28 may be activated for a preset amount of time. The button may then be pressed a second time to send a second signal to the controller to move the holders 26 into the second position, opening the fluid pathway. In another example, the button may activate the sterilization process by activating a controller associated with a timer. Once the button is pressed, the controller may move the holders 26 into a first position where they are sterilized for a preset amount of time. After sufficient sterilization, the controller may automatically move the holders 26 to a second position, opening the fluid pathway. The controller may then return holders 26 to their initial positions after a preset amount of time or by the user pressing the button a second time sending a second signal to the controller. In another instance, a two-button system may be utilized, where a first button may be pressed to move the holders 26 into the first position, and the second button may be pressed to move the holders 26 into the second position.
Sterilization chamber 12 includes or may be otherwise associated with a light source for providing sterilizing light to sterilization chamber 12. The light source 28 may be housed within base unit 14 and/or upper region of handle 18, such that the connectors 22a, 22b are irradiated from below. In one embodiment, the inner surface of top wall 16a of lid 16 may be coated with a reflective material to provide more uniform irradiation to connectors 22a, 22b and the flow path established by the connectors. For example, the inner surface of top wall 16a may have a mirror finish. In one embodiment, the light source 28 is located in the center of the base 14. In another embodiment, the light source 28 may span the entire area between the holders 26.
In yet another embodiment, the light source 28 may be placed anywhere inside the sterilization chamber 12, such that the reusable connectors 22a, 22b will be irradiated by the light source 28. For instance, the light source 28 could be associated with the lid 16, such that the light source 28 would irradiate the reusable connectors 22a, 22b from above.
The light source 28 may be, but is not limited to being, an LED light source emitting UV-C light. In an embodiment, the light source 28 may be a UV-C germicidal bulb. Other sterilizing light sources known in the art may be used without departing from the scope of the disclosure. Device 10 may further include a power supply for powering light source 28. Power supply may be housed in handle 18. In one embodiment, the power supply may be a rechargeable battery. In another embodiment, the power supply may be a cord to be plugged into an electrical socket in a wall. The cord may be long enough to allow for mobile use of the device 10.
The hand-held device 10 may be used to create a temporary sterile connection flow path between a source of fluid and other containers. For instance, it may be desirable to transfer fluid from a source container with a large volume of fluid to many smaller containers. In another aspect, the device may be used to take samples from large biological processes requiring sterile pathways.
Sterilization of connectors using hand-held device 10 is further shown in
Once the reusable connectors 22a, 22b are attached to the tubing ends 30, at step 42 the connectors 22a, 22b are located within the sterilization chamber 12 by mounting them into a holder 26, as seen in
At step 44 the connectors 22a, 22b are temporarily joined together. To join the connectors 22a, 22b, the actuator 20 is moved/pressed to a first position, moving the holders 26 towards one another such that connector 22b enters the open end of connector 22a. Seal members (O-rings 23) create an air-tight seal between connectors 22a and 22b. Furthermore, while in the first position, the light source 28 is activated. The actuator 20 may directly activate the light source 28. The actuator 20 is kept in the first position for a selected period of time, for example, until the flow path established by the connectors 22a, 22b is sufficiently exposed to light and the flow path is sterilized. In one embodiment where the sterilizing medium is UV-C and the connector housings are made of cyclic olefin copolymer, the duration of irradiation by the light source may be anywhere between 0.1 seconds and 300 seconds. It will be understood that the duration of irradiation may depend, at least in part, on the light intensity.
After the flow path is sufficiently irradiated and sterilized, at step 48 the actuator 20 is further depressed towards the handle 18 to a second position. In the second position, the light source is turned off and the connectors 22a, 22b are moved closer together to engage the O-ring face seals of the spring-plunger system, opening the flow path. With an open flow path between processing systems established, fluid from one system, for example a source of fluid, may flow through the sterilized connection and into a second system.
Once the desired transfer of fluid through the sterilized flow path is complete, the actuator 20 may be released, returning it to its starting position. By releasing the actuator 20, the holders 26 are returned to their starting positions near the ends of the base 14, thus closing the fluid pathway and disconnecting the connectors 22a, 22b. At this point, the lid 16 may be opened to remove the reusable connectors 22a, 22b from the device 10. Both connectors 22a, 22b can be removed from the device. Alternatively, a single connector 22 may be removed and replaced with a new connector attached to a tube in preparation to create a new sterile pathway.
Aspects of the present subject matter described above may be beneficial alone or in combination with one or more other Aspects, as described below.
Aspect 1. A hand-held sterilization device including a sterilization chamber defined by a base unit and a lid, an at least one holder within the sterilization chamber, a handle supporting the sterilization chamber, and an actuator configured to cause movement of said at least one holder.
Aspect 2. The sterilization device of Aspect 1, wherein the lid is attached to the base unit.
Aspect 3. The sterilization device of any one of Aspects 1 and 2, wherein the lid comprises slots configured to receive tubing when the lid is in a closed position.
Aspect 4. The sterilization device of any one of Aspects 1-3, comprising a first holder and a second holder.
Aspect 5. The sterilization device of any one of Aspects 1-4, wherein one of the at least one holder is moveable.
Aspect 6. The sterilization device of any one of Aspects 4 or 5, wherein the first and second holder are moveable towards each other.
Aspect 7. The sterilization device of Aspect 6, wherein both the first holder and second holder are moveable to a first position and a second position.
Aspect 8. The sterilization device of any one of Aspects 1-7, wherein the at least one holder comprises a groove configured to receive a tubing connector.
Aspect 9. The sterilization device of any one of Aspects 1-8, wherein the actuator is a trigger on the handle.
Aspect 10. The sterilization device of any one of Aspects 7-9, wherein the actuator is movable to a first position for moving the at least one holder into the holder first position.
Aspect 11. The sterilization device of any one of Aspects 7-10, wherein the actuator is movable to a second position for moving the at least one holder into a second position.
Aspect 12. The sterilization device of any one of Aspects 7-8, wherein the actuator is a button on the handle, the button being configured to move the at least one holder into the first position when the button is pressed a first time and to move the at least one holder into the second position when the button is pressed a second time.
Aspect 13. The sterilization device of any one of Aspects 7-8, wherein the actuator is a first and second button on the handle, the first button being configured to move the at least one holder to the first position and the second button being configured to move the at least one holder into the second position.
Aspect 14. The sterilization device of any one of Aspects 7-13, wherein sterilization occurs when the at least one holder is in the first position and a fluid pathway is opened when the at least one holder is in the second position.
Aspect 15. A system for providing a sterile fluid pathway connection including 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 hand-held sterilization device includes a sterilization chamber defined by a base unit and a lid, an at least one holder within the sterilization chamber, wherein said at least one holder is configured to receive one of the first or second reusable connectors, 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.
Aspect 16. The system of Aspect 15, wherein the first reusable tube connector is configured to receive the second reusable tube connector to provide a fluid pathway connection.
Aspect 17. The system of any one of Aspects 15 or 16, wherein the at least one holder comprises a first holder and a second holder, the first holder being configured to receive the first reusable tube connector and the second holder being configured to receive the second reusable tube connector
Aspect 18. The system of any one of Aspects 15-17, wherein one of the at least one holder is moveable.
Aspect 19. The system of any one of Aspects 17-18, wherein both the first holder and the second holder are moveable towards each other.
Aspect 20. The system of any one of Aspects 15-19, wherein the actuator is moveable to a first position to move the at least one holder to a first position.
Aspect 21. The system of any one of Aspects 15-20, wherein the actuator is moveable to a second position to open a fluid pathway.
Aspect 22. A method for transferring fluid in a sterile manner including attaching an open first end of a tube to a first tube connector 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, locating said first and second connectors within a sterilization chamber carried by a handle of a hand-held device, wherein the chamber receives light from a light source associated with the device, temporarily joining said first and second connectors 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 for a selected period of time, opening the flow path and flowing fluid form said source of fluid though said flow path, and separating said first and second connectors.
Aspect 23. The method of Aspect 22, further comprising placing the first tube connector into a first holder and the second tube connector into a second holder within the sterilization chamber.
Aspect 24. The method of any one of Aspects 22-23, further comprising moving an actuator to a first position to establish an air-tight seal between the first connector and second connector.
Aspect 25. The method of any one of Aspects 22-24, further comprising moving the actuator to a second position to open the flow path.
It will be understood that the embodiments and examples described above are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including those combinations of features that are individually disclosed or claimed herein. For these reasons, the scope hereof is not limited to the above description but is as set forth in the following claims, and it is understood that claims may be directed to the features hereof, including as combinations of features that are individually disclosed or claimed herein.
This application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 63/319,635, filed on Mar. 14, 2022, the disclosure of which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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63319635 | Mar 2022 | US |