Disposable, sterile fluid transfer device
View Patent ↗The present invention relates to a sterile sample collection device for fluids and a method of using the same. It is comprised of a transfer device having a body with a bore formed through at least a portion of its interior. Contained within the bore is a movable plunger. The body has a first and a second end. The first end contains a face designed to be attached to the upstream component. The second end is connected to tube which is then connected to a collection bag. The plunger has corresponding first and second ends. The first end of the plunger when in the closed position is in alignment with the face of the body which combined form a steamable surface and a sterile barrier against the environment to the rest of the interior of the body, the plunger and downstream components.
1. A sterile fluid transfer device comprising:
a body having a bore formed through at least a portion of its interior, the body including a first end connectable to an upstream component;
a port positioned downstream from the first end of the body, the port formed on a moveable plunger and being connectable to a downstream component;
a fluid pathway through the device between the first end of the body and the port;
the movable plunger contained within the bore, the plunger having a first end and being movable within the bore between a closed position and an open position, the first end of the plunger and at least the first end of the body forming a steamable surface when the plunger is in the closed position, and the plunger enabling a transfer of fluid through the fluid pathway when the plunger is in the open position; and
a sterile barrier between the environment and at least a portion of the plunger and at least a portion of the interior of the body to enable the transfer of fluid through the fluid pathway while maintaining the sterile condition of the fluid being transferred.
2. The device of claim 1 wherein the bore is a central bore formed through a length of the body.
3. The device of claim 1 wherein the port is formed between the first end and a second end of the body.
4. The device of claim 3 wherein the port is positioned at a 90 degree angle to a length of the body.
5. The device of claim 1 wherein the body is formed of a plastic selected from the group consisting of polyetherimides (PEI), polyetheretherketone (PEEK), polyetherketone (PEK), polysulfones, polyarylsulfones, polyalkoxysulfones, polyethersulfones, polyphenylenesulfide, polyphenyleneoxide, and blends thereof.
6. The device of claim 1 wherein the body is formed of polyetherimides (PEI).
7. The device of claim 1 wherein the first end of the body is formed of a material selected from the group consisting of polyetherimides (PEI), polyetheretherketone (PEEK), polyetherketone (PEK), polysulfones, polyarylsulfones, polyalkoxysulfones, polyethersulfones, polyphenylenesulfide, polyphenyleneoxide, and blends thereof, ceramic and metal.
8. The device of claim 1 wherein the plunger is formed of a material selected from the group consisting of polyetherimides (PEI), polyetheretherketone (PEEK), polyetherketone (PEK), polysulfones, polyarylsulfones, polyalkoxysulfones, polyethersulfones, polyphenylenesulfide, polyphenyleneoxide, and blends thereof, ceramic and metal.
9. The device of claim 1 wherein the plunger is formed of polyetherimide (PEI).
10. The device of claim 1 wherein the downstream component is at least one of a bag, a sterile connector, a sanitary flange, a tube, a filter, or a pipe.
11. The device of claim 1 wherein the plunger includes one or more openings that form a fluid connection to the downstream component.
12. The device of claim 1 wherein the plunger, when in the closed position, seals off the downstream component from the upstream component.
13. The device of claim 1 wherein the body is formed of a steam resistant material.
14. The device of claim 1 wherein the surface formed by the first end of the body and the first end of the plunger is formed of metal.
15. The device of claim 1 wherein the body is formed of a plastic.
16. The device of claim 1 wherein the steamable surface further comprises a seal.
17. The device of claim 1 wherein the sterile barrier further comprises at least one seal.
18. The device of claim 17 wherein the sterile barrier further comprises at least three seals.
19. The device of claim 17 wherein the at least one seal is a gland seal.
20. A sterile fluid transfer device comprising:
a body having a bore formed through at least a portion of its interior, the body including a first end connectable to an upstream component;
a filter in fluid communication with the bore, the filter having a steam sensitive membrane;
a fluid pathway through the device;
a movable plunger contained within the bore, the plunger having a first end and being movable within the bore between a closed position and an open position, the first end of the plunger and at least the first end of the body forming a steamable surface when the plunger is in the closed position, and the plunger enabling a transfer of fluid through the fluid pathway when the plunger is in the open position;
a handle for moving the plunger within the bore; and
a sterile barrier between the environment and at least a portion of the plunger and at least a portion of the interior of the body to enable transfer of fluid through the fluid pathway while maintaining the sterile condition of the fluid being transferred.
21. The device of claim 1 , wherein the bore comprises a first bore section proximate the first end and having a first diameter, a second bore section having a second diameter larger than the first diameter and downstream from the first bore section, and a transition bore section between the first and second bore sections, and wherein the plunger has a shape corresponding to that of the bore.
22. A sterile fluid transfer device comprising:
a body having a bore formed through at least a portion of its interior, the body including a first end connectable to an upstream component;
a port connectable to a downstream component;
a fluid pathway through the device between the first end of the body and the port;
a movable plunger contained within the bore, the plunger having a first end and being movable within the bore between a closed position and an open position, the first end of the plunger and at least the first end of the body forming a steamable surface when the plunger is in the closed position, and the plunger enabling a transfer of fluid through the fluid pathway when the plunger is in the open position;
a handle for moving the plunger within the bore; and
a sterile barrier between the environment and at least a portion of the plunger and at least a portion of the interior of the body to enable the transfer of fluid through the fluid pathway while maintaining the sterile condition of the fluid being transferred.
23. A sterile fluid transfer device comprising:
a body having a bore formed through at least a portion of its interior, the body including a first end connectable to an upstream component;
a port formed on a portion of the body downstream of the first end of the body, the port being connectable to a downstream component;
a fluid pathway through the device between the first end of the body and the port;
a movable plunger contained within the bore, the plunger having a first end and being movable within the bore between a closed position and an open position, the first end of the plunger and at least the first end of the body forming a steamable surface when the plunger is in the closed position, and the plunger enabling a transfer of fluid through the fluid pathway when the plunger is in the open position;
a handle for moving the plunger within the bore; and
a sterile barrier between the environment and at least a portion of the plunger and at least a portion of the interior of the body to enable the transfer of fluid through the fluid pathway while maintaining the sterile condition of the fluid being transferred.
24. A sterile fluid transfer device comprising:
a body having a bore formed through at least a portion of its interior, the body including a first end connectable to an upstream component;
a port positioned downstream from the first end of the body, the port being connectable to a downstream component;
a fluid pathway through the device between the first end of the body and the port;
a movable plunger contained within the bore, the plunger having a first end and being movable within the bore between a closed position and an open position, the plunger enabling a transfer of fluid through the fluid pathway when the plunger is in the open position;
a handle for moving the plunger within the bore; and
a sterile barrier between the environment and at least a portion of the plunger and at least a portion of the interior of the body to enable the transfer of fluid through the fluid pathway while maintaining the sterile condition of the fluid being transferred.
25. A sterile fluid transfer device comprising:
a body having a bore formed through at least a portion of its interior, the body including a first end connectable to an upstream component;
a port positioned downstream from the first end of the body, the port being connectable to a downstream component;
a fluid pathway through the device between the first end of the body and the port;
a movable plunger contained within the bore, the plunger having a first end and being movable within the bore between a closed position and an open position, the first end of the plunger and at least the first end of the body forming a steamable surface when the plunger is in the closed position, and the plunger enabling a transfer of fluid through the fluid pathway when the plunger is in the open position;
a handle for moving the plunger within the bore; and
a sterile barrier between the environment and at least a portion of the plunger and at least a portion of the interior of the body to enable the transfer of fluid through the fluid pathway while maintaining the sterile condition of the fluid being transferred through at least one actuation.
26. The device of claim 25 wherein the sterile condition is maintained through multiple actuations.
27. A sterile fluid transfer device comprising:
a body having a bore formed through at least a portion of its interior, the body including a first end connectable to an upstream component;
a port positioned downstream from the first end of the body, the port being connectable to a downstream component;
a fluid pathway through the device between the first end of the body and the port;
a movable plunger contained within the bore, the plunger having a first end and being movable within the bore between a closed position and an open position, the first end of the plunger and at least the first end of the body forming a steamable surface when the plunger is in the closed position, and the plunger enabling a transfer of fluid through the fluid pathway when the plunger is in the open position; and
a sterile barrier between the environment and at least a portion of the plunger and at least a portion of the interior of the body to enable the transfer of fluid through the fluid pathway while maintaining the sterile condition of the fluid being transferred, the sterile barrier comprising at least three seals.
28. A sterile fluid transfer device comprising:
a body having a bore formed through at least a portion of its interior, the body including a first end connectable to an upstream component;
a port positioned downstream from the first end of the body, the port being connectable to a downstream component;
a fluid pathway through the device between the first end of the body and the port;
a movable plunger contained within the bore, the plunger having a first end and being movable within the bore between a closed position and an open position, the first end of the plunger and at least the first end of the body forming a steamable surface when the plunger is in the closed position, and the plunger enabling a transfer of fluid through the fluid pathway when the plunger is in the open position; and
a sterile barrier between the environment and at least a portion of the plunger and at least a portion of the interior of the body to enable the transfer of fluid through the fluid pathway while maintaining the sterile condition of the fluid being transferred, the sterile barrier comprising at least one seal wherein the at least one seal is a gland seal.