WO1999001070A1

WO1999001070A1 - Sterile syringe protector

Info

Publication number: WO1999001070A1
Application number: PCT/US1998/013726
Authority: WO
Inventors: Dominick G. Esposito; Abigail Freeman; David H. Sierra
Original assignee: Cohesion Corporation
Priority date: 1997-07-02
Filing date: 1998-07-01
Publication date: 1999-01-14
Also published as: AU8380198A

Abstract

The present invention relates to a sterile syringe protector (1) which has a pair of telescoped inner, outer tubes (10, 20) sliding, and sealing fit with each other. Each of the inner, and outer members (10, 20) has a free end (12, 24). The inner tube member (20) is adapted to receive at least part of a syringe body. A cap member (30) is provided to be sealing and removably fit at the free end (24) of the outer tube member (10), and engage a syringe handle. The sterile syringe protector (1) also has a fitting (40) at the free end of the inner tube member. The sterile syringe protector (1) encloses the syringe with its outer tube (10) adapted to move with the syringe handle to protect the syringe from contamination during fluid processing.

Description

STERILE SYRINGE PROTECTOR

FIELD OF THE INVENTION The present invention generally relates to a sterile protector for a syringe which allows the syringe to be manipulated in various fluid processing while protecting the outer surface of the syringe against contamination. More specifically, the present invention relates to a telescoping syringe protector which sealingly receives a sterile syringe and works with the syringe in taking a fluid sample and having other fluid processing, such as centrifugation, performed thereon before releasing the syringe to a sterile environment. The sterile syringe protector of the present invention allows fluid processing to be conducted in a non- sterile environment and later delivers the sterile syringe in a sterile field without any fluid transfer.

BACKGROUND OF THE INVENTION A conventional process of obtaining a biological or other fluid samples such as a blood sample and the subsequent centrifugation process usually require multiple steps of fluid transfer with use of multiple devices. In preparing a blood sample, typically a vacuum container or standard syringe is used to withdraw blood. The container of blood is placed into a centrifuge to be centrifuged. After centrifugation, the separated plasma must be transferred to another container or syringe for further processing or use.

In each fluid transfer, the syringe or other container containing the fluid sample must be sterilized or disinfected. Hence, such multiple steps and devices in preparation of the fluid sample can cause extra cost and time and overall inconvenience. In addition, risks of contamination of the sample and/or infection of the medical personnel can increase as the amount of handling and the number of devices increase .

SUMMARY OF THE INVENTION In view of the above problems and disadvantages of the prior art, it is an object of the present invention to provide a device for processing a fluid sample with the least fluid transfer in order to decrease handling by medical personnel, to reduce risks of contamination or fluid loss and to reduce the number of devices involved in the process to thereby minimize costs for obtaining such fluid sample.

It is a further object of the present invention to ^• provide a device which allows a sterile syringe for fluid processing in a non-sterile environment and later delivers the sterile syringe containing a fluid sample to a sterile field without any fluid transfer.

It is yet a further object of the present invention to provide a device which protects a sterile syringe from contamination or infection in fluid processing. The present invention relates to a sterile syringe protector. The sterile syringe has a pair of telescoped inner and outer tube members slidably and sealingly fit with each other. Each of the inner and outer members has a free end. The inner tube member is adapted to receive at least part of a syringe body. A cap member is provided sealingly and removably fit at the free end of the outer tube member for engaging a syringe handle .

The sterile syringe protector also has a luer or other suitable connector at the free end of the inner tube member. The connector has a first portion for removably connecting with a syringe fitting. The sterile syringe protector encloses the syringe with its outer tube adapted to move with the syringe handle to protect the syringe from contamination during fluid processing. The cap member of the sterile syringe protector can be a screw key cap. In a preferred embodiment, the outer tube member has threads provided on its outer surface at the free end and the cap member has a matching thread provided thereon for engaging with the free end of the outer tube member. Alternatively, the outer tube member has a peripheral flange provided on its out surface at the free end and the cap member has an circular recess for engaging with the flange at the free end of the outer tube member.

In a preferred embodiment, the inner and outer tube members of the sterile syringe protector are cylindrical tubes each having a central axis . The outer tube has a keyway in its inner surface extending parallel to the central axis. The inner tube has a key on its outer surface slidably engaging the keyway on the inner surface of the outer tube . In an alternative embodiment, the inner and outer tube members each can have an oval cross-section to thus prevent relative rotation.

The present invention also relates to a sterile syringe assembly. The sterile assembly comprises a syringe having a syringe body, a syringe fitting such as a luer sealed at an end of the syringe body, a plunge member slidably fit in the syringe body and a plunge handle connected to the plunge member and extended out of the syringe body. A pair of telescoped inner and outer tube members slidably and sealingly fit with each other. Each of the inner and outer members has a free end. The inner tube member is adapted to receive at least part of the syringe body. A cap member is provided sealingly and removably fit at the free end of the outer tube member and engage a syringe handle .

In the syringe assembly of the present invention, the inner and outer tube members are cylindrical tubes each having a central axis. The outer tube has a keyway in its inner surface extending parallel to its central axis.

BRIEF DESCRIPTION OF THE DRAWINGS These and other features, aspects, and advantages of the present invention will become much more apparent from the following description, appended claims, and accompanying drawings, in which:

Fig. 1 is an exploded and cross-sectional view of a sterile syringe protector of the present invention; Fig. 1A is a partial cross-sectional view of an alternative embodiment of the invention including the free end of the inner tube of Fig. 1 ;

Fig. 2 is a left end view of the sterile syringe protector shown in Fig. 1; Fig. 3 is a cross-sectional view showing a sterile syringe protector of the present invention in use with a sterile syringe; and

Fig. 4 is a partial cross-sectional view showing the assembly of a sterile syringe protector and a sterile syringe in use with a cell separation device.

DETAILED DESCRIPTION OF THE INVENTION Various sterile syringe protectors embodying the principles of the present invention are illustrated in Figs. 1-4. These sterile syringe protectors can sealingly enclose sterile syringes therein to protect the same against contamination in fluid processing. Hence, such sterile syringe protectors allow fluid processing in a non-sterile or aseptic environment and later deliver the sterile syringe into a sterile field without fluid transfer. In each embodiment, the same elements are designated with the same reference numerals and repetitive descriptions are omitted.

Referring to Fig. 1, a sterile syringe protector 1 of the present invention is shown with its exploded components. The sterile syringe protector 1 has a pair of inner and outer tube members 10, 20 adapted to be telescoped with each other as shown in the later drawings . The outer tube member 10 has such an inner dimension that it can accommodate the inner tube member 20 and be sealingly slidable along the outer surface 22 of the inner tube member 20. Each of the outer and inner tube members 10, 20 has a free end 12, 24 thereon which is adapted to connect with a fitting member 40 and a cap member 30 respectively, as will be described hereinafter. The joints between the components are sealingly formed so that the sterile syringe protector 1 is an enclosed chamber to accommodate a sterile syringe and protect a syringe against contamination. Alternatively, a fitting 40 can be integrally incorporated into free end 24, as shown in Fig. 1A.

The outer and inner tube members 10, 20 can have various circular or non-circular cross-sections such as an oval or square shape. One advantage of such an oval shaped tube members 10, 20 is that they can fit with each other without any relative rotation. In a preferred embodiment of the present invention, the tube members 10, 20 are cylindrical tubes 10, 20 each having a circular cross- section. The outer tube 10 has such an inner diameter that it can sealingly and slidably fit onto the outer surface 22 of the inner tube 20 to accommodate at least a part of the inner tube member 20.

When the outer and inner tube members 10, 20 are cylindrical tubes as described hereinabove, the inner surface 14 of the outer tube member 10 can have a keyway 16 extending parallel to the axis of the outer tube member 10. This keyway 16 is to cooperate with a key member 26 on the outer surface 24 of the inner tube member 20 to restrain any rotation between the two tube members 10, 20.

At the free end 12 of the outer tube member 10, there is provided a connecting member 18 for sealingly and removably joining the cap member 30. The connection between the outer tube member 10 and the cap member 30 at the free end 12 can be various conventional joints, such as a screw connection and a locking detent connection. Therefore, the connecting member 18 is a mating part of such a joint. In a preferred embodiment, the connecting member 18 is a thread member provided on the outer surface 19 of the outer tube member 10. Alternatively, the connecting member 18 can be a mating part of a locking detent such as a circular flange for engaging a complemental member on the cap member 30. The cap member 30 has an end surface 34 which extends beyond the outer surface 19 of the outer tube member 10 and thus can cover an opening formed by the free end 12 of the outer tube member 10. A connecting member 32 is provided on the cap member 30 which joins to the peripheral of the end surface 34 and extends traversely in relation to the end surface 34. The connecting member 32 is adapted to engage with the connecting member 18 on the outer tube member 10 as mentioned hereinabove. Accordingly, the connecting member 32 on the cap member 30 is preferably complemental to the connecting member 18 on the outer tube member 10. In the case when the cap member 30 is a screw key cap, the connecting member 18 can be an outer thread member on the outer tube member 10 and the connecting member 32 can an inner thread member on the cap member 30 or vice versa . Alternatively, when the connecting member 18 is a circular flange member (not shown) on the outer tube member 10, the connecting member 32 is a circular recess member (not shown) on the cap member 30 or vice versa . The cap member 30 also has a capturing member 36 located on the same side of the end surface 34 as the connecting member 32. One embodiment of the capturing member 36 includes a supporting surface 36a protruding from and positioned substantially parallel to the end surface 34. Capturing member 36 also has at least one finger member 36b extends from the supporting surface 36a to form a slot member 36c therebetween. When the sterile syringe protector 1 houses a sterile syringe, the slot member 36c of the capturing member 36 accommodates the handle flange. The finger member 36b of the capturing member 36 captures the plunger rod flange against the supporting surface 36a. Thereby, capturing member 36 carries the cap member 30 and the outer tube member 10, in turn, to move along with the syringe handle and in relation to the inner tube member 20 as will be described later.

In an alternative embodiment as shown in Fig. 3, the capturing member 36 has plural discontinued supporting surfaces 36a. One finger member 36b extends from each supporting surfaces 36a to form a slot member 36c therebetween. When assembled, the finger members 36b hold the handle flange against the supporting surface 36a along the peripheral of the handle flange.

Referring back to Fig. 1, the sterile syringe protector 1 has fitting member 40 for sealingly fitting in the opening formed by the free end 24 of the inner tube member 20. The fitting member 40 can be in the shape of a plug or integrally formed, having first and second ends 40a, 40b. The plug 40 has first and second portions 42, 44, preferably with the first end 40a arranged at the first portion 42. Portion 44 is adapted to be sealingly fit in a connecting member 28 formed at the free end 24 of the inner tube member 20 if not integrally formed. Thus, the sterile syringe protector 1 becomes an enclosed chamber for housing the sterile syringe.

In a preferred embodiment of the present invention, portion 44 on fitting member 40 has a thread member provided thereon. The thread member 44 is adapted to engage with the connecting member 28 of the inner tube member 20, which is a mating thread member. Alternatively, the connection between the cover member 40 and the inner tube member 20 can be a locking detent, similar to the connection between the first portion 42 and a luer or needle fitting 2b as shown in Fig. 3. In this case, the second portion 44 of the cover plug 40 can have a circular flange and the connecting member 28 of the inner tube member 20 can have a mating circular recess, or vice versa . Other conventional sealing joints, as well as integral molding, can be adopted for the connection between fitting member 40 and the inner tube member 20.

First portion 42, 42a of fitting 40 is provided to sealingly and removably connect to a fitting of the sterile syringe. In one embodiment, first portion 42 includes a circular flange for fitting with a circular recess in the syringe needle fitting. Other conventional sealing joints, such as thread 42a or luer, can be adopted for the connection between fitting 40 and the syringe fitting.

Fig. 3 shows that the sterile syringe protector 1 sealingly encloses a sterile syringe 2 to form a sterile syringe assembly 1' . The sterile syringe 2 can be of any conventional syringe, which includes a syringe body 2a, a needle fitting 2b, a plunge handle 2c and a handle flange 2d.

In assembling the syringe protector 1 with the sterile syringe 2, the syringe protector 1 is prepared so that the telescoped outer and inner tube members 10, 20 are sealingly connected with each other and to the cover member 40. The syringe 2 is then inserted into the syringe protector 1 from the opening formed by the free end 12 of the outer tube member 10 so that the needle fitting 2b of the syringe 2 connects with first portion 42, 42a of fitting member 40. The syringe body 2a may provide a key member 2e, aligned with and fit in the keyway 16 of the outer tube member 10. The key member 2e and the keyway 16 cooperate to prevent the syringe body 2a from rotating relative to the outer tube member 10.

The cap member 30 is then fit onto the outer tube member 10 with the capturing member 36 made engaging with the syringe handle flange 2d. Thereby, the sterile syringe 2 can be partly supported by the inner tube member 20 and connected with the sterile syringe protector 1 through connections between first portion 42, 42a and the syringe fitting and between the capturing member 36 and the handle flange 2d of the sterile syringe 2.

Syringe 2 can be sterilized before being placed into syringe protector 1 or the assembly can be sterilized, such as by irradiation, after being assembled. The syringe protector 1 or at least the interior of the syringe protector 1 can also be sterilized and disinfected before or after assembling. In addition, the sterile syringe 2 can be assembled with the syringe protector 1 in a sterile environment. Therefore, the sterile syringe 2 is protected within a sterile environment in the interior of protector 1 until it is removed.

When the outer tube member 10 is forced to move relatively to the inner tube member 20, cap member 30 carries 5 the syringe handle to move along with the outer tube member 10. In this way, the sterile syringe 2 can be used to perform various fluid processing while being enclosed in the sterile syringe protector 1. Thereby, the sterile syringe 2 can be protected in a sterilized environment throughout the

10 fluid processing even though the entire sterile syringe assembly may not be surrounded by a sterilized environment. ^' Hence, the sterile syringe 2 can later be delivered to a sterilized environment without any fluid transfer.

Fig. 4 shows that the sterile syringe assembly 1'

15 of the present invention is connected with a fluid device 3, such as a centrifugation cell separator. As illustrated, the cell separator 3 has an opening 5, which is adapted to be sealingly connected with the cover plug 40.

Fitting member 40 also includes a third portion 46

20 for sealingly connecting with the opening 5 of the cell separator 3. The third portion 46 of fitting member 40 can be in fluid communication with the first and second portions 42, 44 of the fitting member 40. Preferably, the third portion 46 is integrated with the first and second portions

25 42, 44 to form a single piece. The opening 5 of the cell separator 3 may be in the form of a circular flange, adapted to sealingly fit in the fitting member 40 at second end 40b. Other conventional sealing joints can also be adopted for the connection between the cover member 40 and the cell separator

30 3.

In addition, a luer end 48 can be integrated with the first, second and third portions 42, 44, 46. Luer end 48 is also adapted to receive a syringe needle or a luer component tip (not show) for drawing a fluid sample.

35 After the syringe assembly 1' (FIG. 3) draws a fluid sample, it is sealingly fit with the cell separator 3 for subsequent fluid processing such as a centrifugation process. During such centrifugation process, the sterile syringe 2 is protected in a sterilized environment even though the entire sterile syringe assembly may be exposed to a non-sterilized environment. At the end of fluid processing, the syringe assembly 1' can be removed from the cell separator 3. Then, the cap member 30 can be screwed or pulled open to release the sterile syringe 2 directly into a sterile environment. According to the present invention, no fluid transfer is needed between the non-sterile environment and the sterile environment .

A method of use according to the present invention is as follows: The syringe and syringe protector according to the invention are sterilized within a sterile environment. At this point, typically, the syringe would be empty. While within the sterile environment, the syringe is placed within the protector as described above . The syringe protector then may be removed from the sterile environment without compromising the sterility of the syringe because it is completely contained within the protector.

Alternatively, the parts may be assembled in a non- sterile environment and then sterilized inside and out by irradiation or other means of sterilization. Outside the sterile environment, the syringe within the protector may be manipulated to draw fluid into the syringe body through a needle or other connection attached to the fitting member. Additionally, further fluid processing steps, such as centrifugation, using a cell separator as described above may also be performed without jeopardizing the sterility of the syringe itself. Once all fluid processing steps are complete, the syringe, containing sterile fluid, may be passed directly into the sterile environment. To do so, a nurse or other technician outside the sterile environment may handle the protector to open it and expose the syringe, without actually touching the syringe. A sterile nurse or technician within the sterile environment then may grasp the syringe and remove it from the protector without contaminating the outer surfaces of the syringe because that person is sterile. The sterile nurse may then carry the entire syringe and fluid contained therein into the sterile environment. Depending on the particular use of the invention, a first sterile environment, in which the syringe and protector are prepared, may be the same environment or a different environment from the second sterile environment into which the syringe is passed for final use.

One procedure especially well suited for the present invention is the separation of blood plasma and its provision in a sterile field, such as the operating room, for use with the patient from whom the blood was withdrawn. In a contemplated procedure, blood may be withdrawn from a patient in the operating room or prior to entering the operating room. Such blood may be contained in a syringe. Typically, processing of blood to obtain plasma is done outside the operating room, in an environment that is not sterile, at least not to the level required in the operating room. Once the syringe containing the blood has been centrifuged to contain fractions of plasma and cells, the plasma must be transferred to the operating room, but the syringe cannot be because the outside of the syringe has been contaminated by handling. With the present invention, the syringe containing plasma can be easily docked with a syringe in a protector as described above. Plasma is easily transferred into the sterile syringe in the syringe protector without concern for contaminating the outside of the second syringe. The second, sterile syringe is then passed into the operating room as described above . The foregoing description is only illustrative of the principle of the present invention. It is to be recognized and understood that the invention is not to be limited to the exact configuration as illustrated and described herein. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention. The scope of the present invention accordingly is to be defined as set forth in the appended claims.

Claims

What is claimed is:

1. A syringe protector comprising: a pair of telescoped inner and outer tube members slidably and sealingly fit one within the other, each of the inner and outer members having a free end, the inner tube member configured and dimensioned to receive at least part of a syringe body; a cap member sealingly and removably fit at the free end of the outer tube member and including syringe handle engaging element; and a fitting member sealing the free end of the inner tube member and having a first portion for removably connecting with a syringe fitting; whereby the sterile syringe protector can enclose a syringe with its outer tube member movable with the syringe handle to protect the syringe from contamination during fluid processing.

2. The syringe protector of claim 1 wherein the fitting member is integrally formed with the inner member at the inner member free end.

3. The syringe protector of claim 2 wherein the fitting member is a plug received in an opening in the free end of the inner member.

4. The syringe protector of claim 2 wherein the fitting member has an outer luer connector.

5. The syringe protector of claim 3 wherein the fitting member has an outer luer connector.

6. The syringe protector of claim 2 wherein the fitting member has an inner portion which is cylindrical and has a thread.

7. The syringe protector of claim 1 wherein the cap member is a screw key cap.

8. The syringe protector of claim 7 wherein the outer tube member has threads provided on its outer surface at the free end and the cap member has a matching thread provided thereon for engaging with the free end of the outer tube member .

9. The syringe protector of claim 1 wherein the outer tube member has a peripheral flange provided on its outer surface at the free end and the cap member has an inner recess for engaging with the flange at the free end of the outer tube member.

10. The syringe protector of claim 1 wherein the inner and outer tube members are cylindrical tubes each having a central axis .

11. The syringe protector of claim 10 wherein the outer tube has a keyway in its inner surface extending parallel to the central axis.

12. The syringe protector of claim 11 wherein the inner tube has a key on its outer surface slidably engaging the keyway on the inner surface of the outer tube .

13. The syringe protector of claim 1, further comprising, in combination, a syringe received within said inner and outer members, said syringe having a syringe body with a syringe fitting at one end and a plunger handle opposite, wherein said syringe fitting mates with the fitting member and said plunger handle is engaged by the engaging element such that the syringe is operatively enclosed in a sterile environment.

14. A syringe protector assembly comprises: a syringe having a syringe body, a fitting at an end of the syringe body, a plunger member slidably fit in the syringe body and a plunge handle connected to the plunger member and extending out of the syringe body; a pair of telescoped inner and outer tube members slidably and sealingly fit with each other, each of the inner and outer members having a free end, the inner tube member sized to receive at least part of the syringe body; a cap member sealingly and removably fit at the free end of the outer tube member and engaging the syringe handle ; and a fitting member sealing the free end of the inner ^' tube member and having a first portion for removably connecting with the fitting of the syringe, whereby outer surfaces of the syringe are protected within said tube members against contamination during fluid processing and handling.

15. The syringe assembly of claim 14 wherein the inner and outer tube members are cylindrical tubes each having a central axis, the outer tube having a keyway in its inner surface extending parallel to its central axis and the inner tube having a key on its corresponding outer surface slidably engaging the keyway on the inner surface of the outer tube.

16. A method for sterile handling of a syringe and fluid contained therein, comprising: sterilizing a syringe; sterilizing a syringe protector casing, which casing receives and encases the syringe in a sterile manner while permitting operation of the syringe; placing the syringe in said protector casing; drawing a fluid into the syringe within said protector casing; and passing the fluid into a sterile environment by passing the syringe containing the fluid into the sterile environment by removing the syringe from said protector casing.

17. The method according to claim 16 wherein said sterilizing steps are accomplished by sterilizing the syringe within the protector casing.

18. The method according to claim 17, wherein said sterilizing steps comprise irradiating.

19. The method according to claim 16, further comprising processing the fluid within the syringe while the syringe is contained in the protector casing.

20. The method according to claim 19, wherein said processing includes centrifugation.

21. The method according to claim 16, wherein said passing comprises a non- sterile operator holding the protective casing and opening said casing to expose the syringe and a sterile operator grasping the syringe to remove it from said casing and pass it into the sterile environment.

22. The method according to claim 21, wherein said drawing step comprises drawing a first fraction of a separated fluid from a second syringe into said syringe within the protector casing.

23. The method according to claim 22, further comprising drawing a fluid sample into said second syringe and centrifuging said sample to provide at least first and second fractions within said syringe.

24. The method according to claim 23, wherein said fluid is whole blood and said first fraction is plasma.

25. A method for sterile handling of fluid, comprising: placing a first syringe within a protector casing which permits operation of said syringe while encasing it in a sterile container; sterilizing the first syringe and protector casing; drawing a fluid sample into a second syringe; centrifuging said second syringe to provide first and second fractions of the fluid sample in said second syringe; connecting the second syringe to the first syringe within the protector casing; forcing the first fraction into the first syringe; holding the first syringe through the protector casing to prevent contamination of the first syringe; and opening the protector casing and removing the first syringe to a sterile field by holding the first syringe by sterile means.

26. The method according to claim 25, wherein said sterile means are hands of a sterile user.

27. The method according to claim 25, wherein said drawing, centrifuging, connecting and forcing steps occur outside the sterile field.