This invention relates to a sterile biological material container, and more particularly, to a clean transportation system for a sterile container.
Certain methods and devices have been proposed for maintaining sterility of biological materials when being transported between sterile and nonsterile fields. For instance, in some cases, blood is obtained in a sterile field from a patient and is introduced into a sterile vessel where it is protected from contamination. Then, the vessel is transferred to a nonsterile field and is spun in a centrifuge to separate the components of the blood. Next, a syringe is used to aspirate one or more blood components from the vessel. Subsequently, the blood is aspirated from the syringe into one or more sterile cups located inside the sterile field, and one or more of the separated components is then used depending on the surgical procedure.
However, conventional methods and devices for transporting biological materials between sterile and nonsterile fields suffer from certain disadvantages. For instance, in the example discussed above, the sterility of the blood may be compromised, especially when the blood is introduced to the cups. More specifically, although the cups are located in the sterile field, the cups are still somewhat exposed to the environment inside the operating room, and contamination may occur.
Furthermore, these conventional methods and devices can be time consuming and inconvenient because the fluids are transferred between a substantial number of vessels. In addition, a substantial amount of waste can be produced using these methods because once a vessel is used, it is typically discarded.
A transportation system for transporting a biological material container between a sterile field and a nonsterile field and substantially maintaining sterility of the biological material container is disclosed. The system includes a housing assembly that removably houses the biological material container. The system also includes a port defined by the housing assembly, and the port provides communication into the biological material container from outside the housing assembly. The housing assembly includes a first member that covers a first portion of the biological material container such that a second portion of the biological material container extends from the first member. The housing assembly also includes a second member that covers the second portion of the biological material container. The second member is removably coupled to the first member to expose the second portion of the biological material container.
In another aspect, a biological material container system is disclosed that includes a biological material container having a first portion and a second portion. The system also includes a transportation system for transporting the biological material container between a sterile field and a nonsterile field and substantially maintaining sterility of the biological material container. The transportation system includes a housing assembly that removably houses the biological material container and a port defined by the housing assembly. The port provides communication into the biological material container from outside the housing assembly. Also, the housing assembly includes a first member that covers a first portion of the biological material container such that the second portion of the biological material container extends from the first member. The housing assembly further includes a second member that covers the second portion of the biological material container. The second member is removably coupled to the first member to expose the second portion of the biological material container for removal of the biological material container from the first member of the housing assembly.
In still another aspect, a method of transporting a biological material container between a sterile field and a nonsterile field and substantially maintaining sterility of the biological material container is disclosed. The method includes encapsulating the biological material container within a housing assembly. The housing assembly includes a first member, a second member removably coupled to the first member, and a port providing communication into the biological material container from outside the housing assembly. The biological material container includes a first portion covered by the first member and a second portion covered by the second member and extending from the first member. The method additionally includes introducing a biological material into the biological material container via the port and transporting the biological material container within the housing assembly between the sterile field and the nonsterile field. Furthermore, the method includes decoupling the second member from the first member and exposing the second portion of the biological material container. Moreover, the method includes removing the biological material container from the first member via the second portion of the biological material container.
Furthermore, a transportation system for transporting a biological material container for centrifugation in a centrifuge is disclosed. The transportation system includes a housing assembly that removably houses the biological material container to maintain sterility of the biological material container. The transportation system also includes a keying member that keys the housing assembly in the centrifuge to maintain a predetermined orientation of the housing assembly in the centrifuge.
Moreover, a centrifuge system is disclosed that includes a housing assembly that removably houses a biological material container to maintain sterility of the biological material container. The centrifuge system also includes a centrifuge with a bucket that receives the housing assembly. The centrifuge centrifuges the housing assembly and the biological material container. Also, the centrifuge system includes a keying member that keys the housing assembly in the centrifuge bucket to maintain a predetermined orientation of the housing assembly in the centrifuge bucket.
Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the embodiments of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein:
The following description of the embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. Moreover, the container system described herein is discussed in association with a biological material container of a type shown in U.S. Pat. No. 7,179,391, which issued Feb. 20, 2007, U.S. Patent Publication No. 2005/0109716, which was filed on Sep. 2, 2004, and/or U.S. Patent Publication No. 2006/0278588, which was filed on May 26, 2006, each of which are incorporated herein by reference. However, it will be appreciated that the container system can be used in association with any suitable biological material container without departing from the scope of the present disclosure.
With initial reference now to
The biological material container 12 is generally a hollow enclosed container. In some embodiments, the container 12 is generally cylindrical and defines an axis A. Furthermore, the container 12 includes at least one port 16a, 16b, 16c. The ports 16a, 16b, 16c provide fluid communication into and out of the container 12. The ports 16a, 16b, 16c can be Luer lock connectors of a male or female type. Furthermore, the ports 16a, 16b, 16c can include an associated cap (not specifically shown) for covering the corresponding ports 16a, 16b, 16c.
The container 12 can be used for containing any suitable biological material. For instance, in one embodiment, the container 12 is used for holding blood. Furthermore, in some embodiments, the container 12 can be inserted into a centrifuge (not specifically shown) for separating the biological materials into components of different densities. It will be appreciated that the container 12 could be of any suitable type. In some embodiments, the container 12 is of a type shown in U.S. Pat. No. 7,179,391, which issued Feb. 20, 2007, U.S. Patent Publication No. 2005/0109716, which was filed on Sep. 2, 2004, and/or U.S. Patent Publication No. 2006/0278588, which was filed on May 26, 2006, each of which are incorporated herein by reference. However, it will be appreciated that the container 12 could be of any other suitable type, including a syringe and the like.
The transportation system 14 generally includes a housing assembly 18 that removably houses (i.e., encapsulates) the biological material container 12 to substantially maintain sterility of the container 12. In some embodiments, the housing assembly 18 is substantially shaped according to an outer shape of the biological material container 12. Also, in some embodiments, the housing assembly 18 is made out of a substantially rigid material. For instance, in some embodiments, the housing assembly 18 is made of a relatively rigid polymer and formed using an injection molding process.
The housing assembly 18 includes a first member 20. The first member 20 is substantially tubular in shape and hollow. Furthermore, the first member 20 defines an open end 22 (
When the container 12 is disposed within the housing assembly 18, the first member 20 covers a first portion 28 (
The housing assembly 18 further includes a second member 34. In some embodiments, the second member 34 is generally ring shaped so as to define a first open end 36 and a second open end 38.
The second member 34 also includes a plurality of hollow side members 40a, 40b. The side members 40a, 40b are substantially box shaped and include a plurality of side walls 42 and a bottom wall 44. The side members 40a, 40b also define an open top end 46. As shown in
The second member 34 can also include a threaded portion 48. The threaded portion 48 can be included on an inner surface of the second member 34 adjacent the second open end 38.
As shown in
The housing assembly 18 additionally includes a cap member 50 (
In some embodiments, the cap member 50 is removably coupled to the second member 34, via a friction fit. More specifically, in some embodiments, the cap member 50 includes a recessed bottom surface 58 (
Furthermore, the tabs 56 extend away from the axis A and outward from the second member 34. As will be explained, the tabs 56 enable removal of the cap member 50 from the housing assembly 18.
Additionally, when the cap member 50 is coupled to the second member 34, the cap member 50 substantially covers the third portion 32 of the biological material container 12.
The housing assembly 18 additionally defines a port 60 (
Furthermore, the housing assembly 18 can include a port cover 62 (
With reference now to
For purposes of the following discussion, it is assumed that the biological material container system 10 is assembled as represented in
Initially, the port cover 62 is removed from the port 60, and blood or other biological material is introduced into the biological material container 12 through the ports 60, 16a. The container 12 and the housing assembly 18 can include a vent (e.g., a hydrophobic vent) to allow pressure to equalize as the biological material is introduced into the biological material container 12. Once the biological material has been introduced, the port cover 62 is re-coupled to the port 60. This can be performed inside or outside a sterile field.
More specifically, in some embodiments, an initial port cover 62 is removed and discarded, the biological material is introduced into the biological material container 12, and a new, sterile, replacement port cover 62 is coupled to the port 60. In some embodiments, the replacement port cover 62 is separately packaged or tethered to the housing assembly 18.
Furthermore, in some embodiments, the initial port cover 62 is removed, leaving a plug (not specifically shown) in the port 60. When it is time to introduce the biological material into the container 12, the plug is removed, and the biological material is introduced into the container 12. Then, a new replacement port cover 62 is coupled to the port 60.
Once the port cover 62 has been replaced, the biological material container system 10 can be moved (e.g., by a circulating nurse, etc.) to a nonsterile field for processing. In some embodiments, the biological material container system 10 is inserted into a centrifuge machine (not specifically shown), and the biological material in the container 12 is centrifuged to separate the components of the biological material. It will be appreciated that the container 12 remains substantially encased within the housing assembly 18 to substantially maintain sterility of the container 12 and the biological material within the container 12. As such, the centrifuge need not be sterilized before centrifuging the container 12.
Then, the biological material container system 10 can be moved to a sterile field (e.g., by the circulating nurse, etc.), and the nonsterile personnel (e.g., the circulating nurse, etc.) can disassemble the housing assembly 18 and expose the biological material container 12 for removal by sterile personnel (e.g., a scrub tech, etc.).
More specifically, in order to disassemble the housing assembly 18, the nonsterile personnel (e.g., the circulating nurse, etc.) holds onto the first member 20 and pushes up on the tabs 56 to move the cap member 50 in an axial direction along the axis A away from the second member 34. Next, the nonsterile personnel unthreads and decouples the second member 34 from the first member 20 by rotating the second member 34 about the axis A. In some embodiments, the threading of the threaded portions 26, 48 allows the second member 34 to be unthreaded from the first member 20 with about one quarter to about one-half of a full turn about the axis A; however, it will be appreciated that the threaded portions 26, 48 can have any suitable threading to allow the components to separate after any suitable amount of turning.
Once the second member 34 is threadably disengaged, the nonsterile personnel slides the second member 34 away from the open end 22 of the first member 20 along the axis A. This exposes the second portion 30 of the container 12 that protrudes from the open end 22. As such, sterile personnel (e.g., the scrub tech, etc.) is able to grasp the exposed second portion 30 of the container 12 and pull the container 12 out of the first member 20 along the axis A. It will be appreciated that this process substantially ensures that the container 12 and the biological material inside the container 12 remain sterile and uncontaminated.
Referring now to
In
In
In
Referring now to
The housing assembly 18″″ also includes a cap member 50″″ that is removably coupled to the hollow member 92 adjacent the open end 94. In some embodiments, the cap member 50″″ is frictionally coupled to the hollow member 92 (i.e., a frictional fitted coupling removably couples the cap member 50″″ and the hollow member 92. The cap member 50″″ defines the port 60″″.
The port 60″″ includes an outer portion 96 and a stem 98, which are in fluid communication with each other. The stem 98 removably couples to the port 16a of the biological material container 12. In some embodiments, the stem 98 extends into and frictionally couples to the port 16a; however, it will be appreciated that the stem 98 can couple to the port 16a in any other suitable manner.
When assembled, the cap member 50″″ covers a first portion 97 of the biological material container 12. Also, the hollow member 92 covers a second portion 99 of the biological material container 12.
To disassemble the system 10″″, non-sterile personnel (e.g., the circulating nurse, etc.) removes the hollow member 92 from the cap member 50″″ and moves the hollow member 92 along the axis A away from the cap member 50″″. This, in turn, exposes the second portion 99 of the biological material container 12. Also, the biological material container 12 extends from and remains coupled to the cap member 50″″, thereby allowing the non-sterile personnel to support the biological material container 12 by holding the cap 50″″. The sterile personnel (e.g., the scrub nurse) is then able to grasp the second portion 99 of the biological material container 12 and remove the container 12 from the cap member 50″″.
It will be appreciated that biological material container system 10, 10′, 10″, 10″′, 10″″ provides a useful, convenient, and effective means of maintain sterility of the biological material container 12 and the biological materials therein. The housing assembly 18, 18′, 18″, 18″′, 18″″ can be easily handled and transported between a sterile and a nonsterile field, and can be quickly and easily disassembled to expose the container 12 for removal from the housing assembly 18, 18′, 18″, 18″′, 18″″. Moreover, the housing assembly 18, 18′, 18″, 18″′, 18″″ can be reused and re-sterilized for use with a plurality of biological material containers 12. More specifically, the housing assembly 18, 18′, 18″, 18″′, 18″″ can be disassembled and reassembled repeatedly (e.g., through the frictional fittings, the threaded couplings, the bayonet couplings, and the slotted couplings, etc.) for added convenience. It will be appreciated, however, that the housing assembly 18, 18′, 18″, 18″′, 18″′ can be disposable along with the container 12.
Referring now to
In the embodiments represented in
The centrifuge system 100 also includes a keying member 106 that maintains a predetermined orientation of the biological container system 10 in the pocket 105. In the embodiments represented in
In each of the embodiments represented in
Accordingly, the biological material container system 10 can be inserted into the pocket 105, and the keying member 106, 106′, 106″ keys and substantially limits movement of the biological material container system 10 against rotation about the longitudinal axis A. As such, it can be ensured that the biological material container system 10 is properly positioned in the pocket 105 of the centrifuge 102 in a predetermined position. In some embodiments, the keying member 106, 106′, 106″ can be configured to ensure proper centrifuging of the biological materials in the biological material container system 10. Also, it will be appreciated that the keying member 106, 106′, 106″ ensures that the biological container system 10 will remain in this predetermined position. Accordingly, the biological material container system 10 is less likely to become unbalanced during centrifuging.
It will be appreciated that the keying member 106, 106′, 106″ can be of any suitable shape and configuration other than those illustrated in
Moreover, the keying member 106, 106′, 106″ can be configured such that the overall shape of the pocket 105 corresponds to the overall shape of the biological material container system 10 and inhibits rotation about the axis A. For instance, the pocket 105 could be shaped so as to have flat surfaces that abut against the side members 40a, 40b (
Moreover a plurality of buckets 104 could be provided, each with pockets 105 of unique shapes (e.g., rectangular, ovate, etc.), and a plurality of biological material container systems 10 could be provided, each having corresponding unique shapes. The biological material container systems 10 would only fit in pockets 105 having the corresponding shape. This would serve to differentiate the biological material container systems 10 for convenient identification thereof.
Furthermore, the foregoing discussion discloses and describes merely exemplary embodiments of the present disclosure. One skilled in the art will readily recognize from such discussion, and from the accompanying drawings and claims, that various changes, modifications and variations may be made therein without departing from the spirit and scope of the disclosure as defined in the following claims.
This application is a divisional of U.S. patent application Ser. No. 13/476,587 filed on May 21, 2012, which is a continuation of U.S. patent application Ser. No. 12/062,817 filed on Apr. 4, 2008, now U.S. Pat. No. 8,182,769 issued on May 22, 2012. The entire disclosures of the above applications are incorporated herein by reference.
Number | Date | Country | |
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Parent | 13476587 | May 2012 | US |
Child | 13863130 | US |
Number | Date | Country | |
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Parent | 12062817 | Apr 2008 | US |
Child | 13476587 | US |