Sample collection system

Abstract

A sample collection system is provided. In one aspect, the sample collection system includes a container, an adapter, and a fixing portion. The adapter receives a first end of the container into its interior. The fixing portion holds the container in a first position where the first end of the container is thereby held in a spaced relationship from the needle of the adapter. The fixing portion is actuated or operates to allow the container to be advanced distally within the interior of the adapter from the first position to a second position so as to engage the needle for receiving a sample into the container. The fixing portion further allows the container to be withdrawn proximally to remove the container from the interior of the adapter, and when the container is removed from the interior of the adapter, the fixing mechanism is removed by the container.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 359,373, filed on July 8, 2022, which is incorporated herein by reference.

[0002] The present technology relates to a sample collection system having an adapter and a disposable sample collection container within which an initial portion of a patient sample is collected. Using venipuncture, the adapter is fluidly coupled to the patient's blood vessel. Initially, the patient sample is drawn into the disposable collection system through the adapter. Once the initial portion of the sample is collected, the disposable sample collection container and the mechanism for holding the disposable sample collection container to the adapter are discarded, and the adapter is fluidly coupled to a sample collector for collecting the remaining portion of the patient sample.

Background Art

[0003] Blood culture testing is currently the preferred method for identifying bacteremia and sepsis. Sepsis is a systemic response to a bacterial infection in the bloodstream and can lead to organ failure and death. One in six infected patients die from sepsis. Furthermore, half of all in - hospital deaths are associated with sepsis. In fact, more people die from sepsis than from the combined total of AIDS, breast cancer, and prostate cancer. Sepsis affects more hospitalized patients than any other diagnosis. Given the morbidity of sepsis, a patient's blood is frequently monitored to determine whether bacteria are present in the blood of patients showing signs of sepsis onset.

[0004] The need to accurately and reliably determine whether a patient has sepsis is clear. Unfortunately, the U.S. healthcare system spends over $4 billion annually on unnecessary treatments related to false-positive blood culture results. See "Oren Zwang & Richard K. Albert, Analysis of Strategies to Improve Cost Effectivenss of Blood Cultures, 1 J. Hosp. Med. 272 (Sep. 2006)". Further, "it is now recognized that most organisms recognized as contaminants in blood cultures originate from the patient's skin". Robert A. Garcia et al., Multidisciplinary Team Review of Best Bractices for Collection and Handling of Blood Cultures to Determine Effective Interventions for Increasing the Yield of True-Positive Bacteremia, Reducing Contamination, and Eliminating False-Positive Central Line-Associated Bloodstream Infections, 43 Am. J. Infect. Control 1222 (Nov. 2015).

[0005] Accordingly, there is a need for a device that can capture the initial flow of blood from a patient that may contain contaminants from the patient's skin in order to prevent that portion of the collected sample from entering the blood culture during the blood collection process. Capturing the initial portion of the collected blood can reduce the number of collection positives. One such device is described in International Publication No. WO 2019 / 018324 to Milan Ivosevic, filed Jul. 17, 2018 as PCT / US2018 / 042367, which is incorporated herein by reference in its entirety. Another such device is described in U.S. Provisional Application No. 62 / 883941, filed Aug. 7, 2019, which is incorporated herein by reference in its entirety.

Summary of the Invention

[0006] A sample collection system is described herein. The system includes a container for collecting a sample, and an adapter having a distal end, a proximal end, a needle, and an interior. The adapter is configured to receive the sample through a connector at the distal end. The sample can be collected by venipuncture or via a venous catheter. The needle extends from the connector into the interior of the adapter, and the proximal end includes an opening for receiving a first end of the container into the interior of the adapter. The system also includes a fixing mechanism configured to releasably fix the container in a first position, in which the first end of the container is held in a spaced relationship from the needle within the interior of the adapter. In one aspect, the fixing mechanism is actuated such that the container is advanced distally within the interior of the adapter from the first position to a second position, thereby enabling engagement with the needle to receive the sample into the container. In one aspect, the fixing mechanism is further configured to enable the container to be pulled proximally to remove the container from the interior of the adapter. In a further aspect, the fixing mechanism is configured to be removed by the container when the container is removed from the interior of the adapter.

[0007] In one aspect, the fixing mechanism includes a collar attached to the container. In a further aspect, the collar has an inner diameter larger than the outer diameter of the container and an outer diameter smaller than the inner diameter of the adapter. In a further aspect, the collar provides an interference fit when advanced into the adapter. In a further aspect, the collar has a flange that prevents the collar from being fully advanced into the adapter.

[0008] In another aspect, the fixing mechanism is a c-clamp. The fixing mechanism may also have an elastic gasket that is received within the container and forms an interference fit for the container within the adapter.

[0009] In another aspect, the container has a cap that may have a septum and a shield. The shield extends from the septum and may surround a portion of the outer perimeter of the container. In a further aspect, the shield described above may have a first O-ring at the proximal end and a second O-ring at the distal end, and each O-ring provides an interference fit when within the adapter.

[0010] In another aspect, the fixing mechanism is a collar on the container that forms an interference fit with the base of the shield in the adapter, and the fixing mechanism provides an interference fit in the adapter when advanced therein. In a further aspect, the collar has a flange at the proximal end of the collar to prevent the collar from advancing completely into the adapter.

[0011] In another aspect, the adapter may have a spring inside the adapter, and the spring provides resistance when the container is advanced into the adapter and engages the needle, and the spring is biased to advance the container out of the adapter after sample collection.

[0012] In another aspect of the sample collection system, the fixing mechanism is a flanged foam rubber collar disposed on the container that forms an interference fit with the adapter when advanced into the adapter, and the flange has a diameter larger than the inner diameter of the adapter to prevent the flanged collar from being advanced completely into the adapter.

[0013] In another aspect of the sample collection system, the fixing mechanism is a foam rubber collar disposed on the container that seats within a flanged opening at the proximal end of the adapter, and the foam rubber collar forms an interference fit with the container but allows the container to be advanced through and withdrawn from the collar.

[0014] In another aspect of the sample collection system, the fixing mechanism is a foam rubber collar fixed to the container that forms an interference fit when introduced into the adapter. In a further aspect, the foam rubber collar is fixed to the container by an adhesive.

[0015] In another aspect of the sample collection system, the fixing mechanism may be a flanged O-ring collar on the container. The O-ring forms a friction fit in the adapter when the container is advanced in the adapter, and the flange does not advance into the adapter. In this aspect, the container is movably accommodated in the flanged portion. In another aspect, a sticker is provided to fix the container in its transport position.

[0016] Another aspect is an alternative mechanism that provides a friction fit for a flange / O-ring assembly that separates the container (i.e., the waste tube) from the adapter needle during transportation. In this aspect, the O-ring is positioned under a cap on the container and has a friction fit within the adapter such that the container is slidably engaged in the adapter. A sticker is provided to fix the container in its transport position.

Brief Description of the Drawings

[0017]

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[0018] Embodiments of the present disclosure are described in detail with reference to the drawings, in which like reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the disclosure, and that the disclosure may be embodied in various forms. Well-known functions or constructions are not described in detail in order to avoid obscuring the present disclosure in unnecessary detail. Accordingly, the specific structural and functional details disclosed herein should not be construed as limiting, but rather as a representative basis for the claims and as a basis for teaching one skilled in the art to employ the present disclosure in virtually any appropriately detailed structure.

[0019] Referring to FIG. 1, a vertical cross-sectional view of a sample collection system 100 is shown in accordance with the present technology. The sample collected by the system of FIG. 1 can be a fluid withdrawn from a patient, such as blood. The system of FIG. 1 includes a container 102 (e.g., a bottle or tube) for collecting or storing the collected sample, and an adapter 150 configured to fluidly couple the collection container (e.g., container 102) fluidly coupled to the adapter to a line set (e.g., a venipuncture needle and tube coupled to the patient) for receiving the sample therefrom. Container 102 is shown as a tube having an open end 104A and a closed end 104B. Container 102 further includes a cap or stopper 106 that includes a septum. Cap 106 is coupled to open end 104A and seals the interior of container 100 from fluid communication with the environment outside of container 100. Container 102 may further include a shield 108 disposed around cap 106 to protect cap 106 from damage during use. Adapter 150 includes a distal end 154A, a proximal end 154B, a body 160 (e.g., configured substantially tubularly), and a needle 158. Adapter 150 has a connector 152 (shown as a luer connector) at distal end 154A of adapter 150. Needle 158 is attached to connector 152 and is in fluid communication with connector 152. Needle 158 extends proximally from connector 152 into interior 156 of adapter 150. Proximal end 154B of adapter 150 includes an opening configured to provide access to interior 156 and to receive end 104A of container 102.

[0020] Sample collection is manufactured and transported in the configuration shown in FIG. 1. In this configuration, the container 102 is separated from the needle 158 and held without engaging the needle 158, which is referred to herein as the first position. During the process of collecting a sample, such as blood from a patient, the end 104A of the container 102 is further advanced from the first position into the interior 156 from the end 154B of the adapter 150 to the second position. As described above, in the first position, the cap 106 is spaced from the proximal end of the needle 158 (e.g., a predetermined distance) and not engaged with the needle 158. In the second position, the needle 158 engages (i.e., pierces) the cap 106 of the container 100 (e.g., where the needle 158 penetrates the septum of the cap 106). Further, the connector 152 is coupled to a corresponding connector for the line set and the line set needle, and the line set needle is used for venipuncture to collect a blood sample from a patient. In some embodiments, the connector 152 can be a male Luer-Lok® adapter or connector connectable to a female Luer-Lok® adapter of the line set, but it should be recognized that other types of connectors for use with adapters and containers, such as the adapter 150 and the container 102, like a catheter in place of the line set, are contemplated within the scope of the present disclosure.

[0021] Container 102 is a sealed container having an internal pressure that is a complete or partial vacuum (i.e., a pressure lower than the atmosphere). When the needle 158 pierces the cap 106, a pressure lower than the atmosphere inside the container 102 draws the initial portion of the blood from the patient through the line set, connector 152, and needle 158 into the interior of the container 102. After the initial portion of the patient sample has been collected, the container 102 is then withdrawn proximally from the interior 156 of the adapter 150, whereby the needle 158 is separated from fluid communication with the interior of the container 102. When the needle 158 is no longer in fluid communication with the interior of the container 102, the flow of blood from the patient stops. The container 102 is then discarded along with the initial portion of the blood collected therein. At this point, a second container (e.g., a blood culture bottle) is advanced into the interior 156 of the adapter 150 to draw blood from the patient. The internal pressure of the second container is also lower than the atmosphere. The blood drawn into the second container serves as the blood to be tested to determine whether the patient's blood contains microbial contamination.

[0022] In some embodiments, the blood collection system of FIG. 1 can be implemented using one of Becton, Dickinson and Company’s (“BD’s”) Vacutainer® blood collection sets, e.g., BD’s Vacutainer® push-button blood collection set, BD’s Vacutainer® Safety-Lok™ blood collection set, or BD’s Vacutainer® UltraTouch™ push-button blood collection set. Thus, in some embodiments, the adapter 150 can be implemented using BD’s Vacutainer® Multiple Sample Luer Adaptor. Further, in some embodiments, the adapter 150 can be implemented using BD’s Vacutainer® One Use Holder.

[0023] As described above, most organisms identified as contaminants in blood cultures originate from the patient's skin. These contaminants are typically introduced into the patient's blood sample by venipuncture and the initial flow of blood from the patient into a container such as container 102 or collection bottle. In the sample collection system 100 described herein, the initial portion of the blood collected from the patient is confined in the first container 102 and then discarded. The second portion of the blood collected from the patient is then collected into a second container and stored for subsequent testing. As a result, the sample collection system 100 described herein potentially reduces the number of false positive blood cultures by discarding the first portion of the collected sample that may result in false positives due to the presence of microbial contamination of the sample from the patient's skin.

[0024] According to the present technology, a fixing mechanism is provided that is configured to releasably hold or fix a container such as container 102 to an adapter such as adapter 150 at a first position (i.e., a spaced-apart relationship where container 102 is not engaged with the needle 158 of adapter 150). Thereby, with container 102 held in the first position relative to adapter 150 by the fixing mechanism, container 102 and adapter 150 can be transported as an assembled unit to a user or technician. After the technician connects the line set to the patient and adapter 150, the fixing mechanism is configured to allow container 102 to be advanced from the first position to a second position. As described above, in the second position, the needle 158 of adapter 150 penetrates the seal of container 102, and a pressure lower than the atmosphere in container 150 draws the patient sample into container 102 through the line set and connector / needle 158. After blood is collected from the patient into container 102, the operator can remove container 102 from adapter 150. The fixing mechanism is further configured to be removed with container 102 when container 102 is removed from adapter 150 by the operator.

[0025] For example, the system of FIG. 1 may include a fixation mechanism 110 configured with the above-described features. As shown in FIG. 1, the fixation mechanism 110 includes a distal end or portion 112 and a proximal end or portion 114. The fixation mechanism 110 may be formed from rubber and may be configured annularly. The fixation mechanism 110 is disposed around the outside of the container 102. The distal portion 112 has a predetermined thickness (between the outer diameter of portion 112 and the inner diameter shared by portions 112, 114) selected to allow portion 112 to fit between the outside of the container 102 and the inner wall 160 of the adapter 150 that defines the inner diameter. Further, the proximal portion 114 is configured as a rim or flange having a predetermined thickness (between the outer diameter of portion 114 and the inner diameter shared by portions 112, 114) selected to be greater than the predetermined thickness of portion 112 such that the outer diameter of portion 114 is greater than the inner diameter of the adapter 150. Thereby, the predetermined thickness of portion 114 ensures that the fixation mechanism 110 is held at the proximal end of the adapter 150 and does not advance distally into the interior 156 of the adapter 150.

[0026] The container 102 is releasably fixed or held in a first position (shown in FIG. 1) and is configured such that in the absence of a force applied to the container 102 by the user, it does not move relative to the adapter 150. A predetermined thickness of the portion 112 is further configured to provide a sufficient amount of friction between the inner diameter of the portion 112 of the fixing mechanism 110 and the outer diameter of the container 102. The diaphragm seal of the cap 106 of the container 102 is engaged with the needle 158 and the user can advance the container 102 from the first position in a distal direction against the friction applied by the fixing mechanism 110 so that the needle 158 penetrates it to a second position. As described above, when the container 102 is advanced from the first position to the second position, the predetermined thickness of the portion 114 prevents the portion 114 from advancing distally into the interior 156 of the adapter 150, so that the fixing mechanism 110 is held at the proximal end 154B of the adapter 150. After an initial portion of the blood sample has been drawn from the patient user into the container 102 (in the manner described above), the container 102 is pulled proximally by the operator or user to remove it from the adapter interior 156. When the container 102 is withdrawn from the interior 156, the fixing mechanism 110 remains disposed around the outside of the body 102 and the fixing mechanism 110 is also withdrawn from the adapter 150 by the removal of the container 102 from the adapter 150.

[0027] It should be recognized that the fixing mechanism of the present technology can take other forms in addition to the fixing mechanism 110 described above. For example, referring to FIG. 2A, a fixing mechanism 210 for use in a sample collection system 110 according to the present technology is shown. The fixing mechanism 210 is configured as a c-clamp configured to be disposed around the outer diameter of the body 102 of the container 100. A gasket, washer or O-ring 212 is provided to provide an interference fit between the adapter 150 and the container 102. The c-clamp 210 may be formed from rubber and includes a predetermined thickness (between the inner and outer diameters of the c-clamp) configured to provide sufficient friction to hold or fix the container 100 in a first position (shown in FIG. 2) so that the container 100 does not move relative to the adapter 150 in the absence of force applied by the user or technician. As described above, the technician may advance the container 102 distally to a second position after venipuncture so that the line set is in fluid communication with the connector 152 and the needle 158 of the adapter 150. In the second position, the needle 158 penetrates the septum seal of the cap 106. A pressure lower than the atmosphere in the container 102 draws the initial portion of the blood from the patient into the container 102. Then, after a sufficient volume of the initial portion is collected to ensure that microbial skin contamination is collected with the initial portion, the container 102 is pulled proximally by the technician to remove the container 102 from the interior 156 of the adapter 150. When the container 102 is removed from the interior 156, the c-clamp 210 remains disposed around the outer diameter of the container 102, so the removal of the container 102 from the interior 156 also removes the c-clamp 210 from the interior 156. In one aspect, when the container 102 is removed from the adapter, the c-clamp 210 and the gasket / washer / O-ring 212 are also removed. According to this aspect, the outer diameter of the shield 108 may be larger than the inner diameter of the c-clamp 210.Thus, when the container 102 is pulled distally to remove it from the interior 156, the proximal end of the shield 108 contacts the c-clamp 210 and the gasket / washer / O-ring 212, and pulls the c-clamp 210 and the gasket / washer / O-ring 212 out of the interior 156 of the adapter along with the container 102.

[0028] As another example, referring to FIGS. 3A and 3B, a fixing mechanism 310 for use in the sample collection system 100 according to the present technique is shown. As shown in FIG. 3A, the fixing mechanism 310 may form a snap fit with a shield 308 for the container 102. At the proximal end of the shield 308, a rim 309 projects in a direction away from the outside of the container 102. Further, the fixing mechanism 310 is annularly configured and is disposed around the outside of the container 102. The fixing mechanism 310 includes rims 312, 314 that extend in opposite directions. The rim 312 is disposed at the distal end of the fixing mechanism 310 and projects towards the outside of the container 102 (i.e., in a direction opposite to the direction in which the rim 309 projects). The rim 314 is disposed at the proximal end of the fixing mechanism 310 and projects in a direction away from the outside of the container 102. The outer diameter of the fixing mechanism 310 from the distal end to before the position of the proximal rim 314 is selected to allow the distal portion of the fixing mechanism 310 to be inserted into the interior 156. The rim 314 extends beyond the inner diameter of the adapter defined by the inner surface 160 and functions as a stop or flange at the proximal end 154B. Thereby, the rim 314 prevents the fixing mechanism 310 from being advanced distally into the container 150 beyond the point where the rim 314 abuts and engages the proximal end of the adapter and holds the fixing mechanism 310 at the proximal end 154B of the adapter 150.

[0029] In use, the end 104A of the container 102 is inserted through the opening of the fixing mechanism 310 into the interior 156 and advanced distally until, as shown in FIG. 3B, the rim 312 contacts the rim 309 and the rim 314 contacts the distal end 154B of the adapter 150. Since the rims 312 and 314 are arranged at a predetermined distance from each other, in the arrangement shown in FIG. 3B, the container 100 is releasably fixed or held in a first position relative to the adapter 150 by the engagement of the rims 309, 312 (and the rim 314 in contact with the end 154B) which prevent the container 102 from being advanced distally within the interior 156. Since the rim 312 and / or the rim 309 are configured to deform slightly when subjected to a force of a predetermined magnitude, a user applying a distal force to the container 100 can press the rim 309 distally beyond the rim 312 (which is held stationary relative to the adapter 150 by the interaction of the rim 314 with the end 154B), advancing the container 100 from the first position to the second position, whereby the needle 158 penetrates the diaphragm of the cap 106. The interaction between the rim 314 and the distal end 154B holds the fixing mechanism 310 against the distal end 154B of the adapter 150 during the distal advancement of the container 102. When the container 102 is removed from the interior 156 by pulling the container 100 proximally, the rim 309 contacts the rim 312 again and pulls the fixing mechanism 310 proximally to remove the fixing mechanism 310 from the adapter 150. When the container 102 is advanced out of the adapter 150, the rim 314 is advanced away from the proximal end 154B of the adapter 150.

[0030] As yet another example, referring to FIG. 4, a fixing mechanism 410 for use in a sample collection system 100 according to the present technology is shown. In the system of FIG. 4, the fixing mechanism 410 is configured as a compressible spring attached to a cap and / or shield 108 at an end 104A of the container 102. The spring 410 is releasably attached to the interior 156 of the adapter 150, e.g., the distal surface 162 (shown in FIG. 4), and is disposed between the distal surface 162 and the cap 106. The spring 410 is configured to bias the container 102 to a first position such that the needle 158 and the cap 106 are spaced apart and do not engage. When the system of FIG. 4 is ready for use (i.e., the line set is connected to the patient and the connector 152), the technician may advance the container 100 distally from the first position against the tension of the spring 410 to a second position, in which the needle 158 engages the cap 106 (i.e., the needle 158 penetrates the diaphragm of the cap 106) and blood is drawn into the container 1020. To maintain the second position and the engagement between the needle 158 and the cap 106, the user must actively hold the container 102 in the second position by applying a distal force to the container 102 to overcome the tension of the spring 410. When the user removes the distal force from the container 100, the tension of the spring 410 advances the container 100 proximally to the second position, automatically separating the cap 106 and the needle 158. Thereafter, the user may remove the container 100 from the interior 156, and since the spring 410 is fixedly attached to the cap 106 and / or shield 108, the removal of the container 100 also removes the spring 410 from the interior 156.

[0031] Figures 5A-5D show another aspect of an assembly with a securing mechanism 510 that maintains the collection / waste tube 102 in a spaced-apart relationship from the adapter needle 108 during transport and storage and allows the collection / waste tube 102 to advance to engage the needle 108 at the adapter 150 for sample collection. As shown, side views in FIGS. 5A-5C of the sample collection system show a foam rubber flange as a securing mechanism 510 that provides the desired separation during transport and storage and remains attached to the waste tube 102 when removed from the adapter 150. In one example, the securing mechanism 510 may include portions 512, 514 configured with the same features described above with respect to portions 112, 114 of the securing mechanism 110. Thereby, portions 512, 514 of the securing mechanism 510 provide an interference fit between the collection / waste tube 102, the foam 510, and the adapter 150. The interference fit holds the tube 102 in a predetermined position relative to the adapter 150 (i.e., a spaced-apart relationship in a first position) but allows easy movement of the tube 102 toward the needle 158 by applying a forward force. Portion 514 has a predetermined thickness greater than the inner diameter of the adapter 150 to ensure that the securing mechanism 510 is held at the proximal end of the adapter 150 and does not advance distally into the interior 156 of the adapter 150. When the tube 102 is pulled out of the adapter 150, the tube 102 and the foam 510 come out of the adapter 150 together. In one example, the securing mechanism 510 includes one or more protrusions 516, 518. The protrusion 516 in the foam 510 is configured to project radially inward from the inner diameter of the foam 510 (defined by the inner diameters of portions 512, 514) to control the interference force between the tube 102 and the foam 104. The protrusion 518 may be at the outer diameter of portion 512 on the adapter side of the foam rubber flange 510. A spot 520 on the collection / waste tube 102 indicates an optional feature where a drop of adhesive may be provided for snap engagement in a receiving hole in the foam flange to attach the foam flange to the collection / waste tube 102.

[0032] FIG. 6 shows another aspect of an assembly with a securing mechanism 610 that maintains the collection / waste tube 102 spaced from the adapter needle 158 during transport and storage and allows the collection / waste tube 102 to advance to engage the needle 158 at the adapter 150 for sample collection. As shown, a side view of the sample / collection discharge tube 102 has a foam rubber flange 610 with a friction fit on the waste tube 102 that is pulled out of the adapter 150 when the tube 102 is removed from the adapter 150. The foam rubber flange 610 has a low-adhesion adhesive for attaching the flange 610 at the base 154B (e.g., a flange at the end) of the adapter 150. The tab defines a spaced relationship between the waste tube 102 and the cap 106 on the waste tube 102. In one aspect, the adhesive strength can be selected to apply a tensile force to the securing mechanism 610 when the cap 106 contacts the securing mechanism 610 as the tube 102 is pulled out of the adapter 150. The tensile force is sufficient to overcome the adhesion between the securing mechanism 610 and the base or flange 154B to detach the mechanism 610 from the base or flange 154B. Thereby, the securing mechanism 610 is carried out of the adapter 150 with the removal of the tube 102.

[0033] FIG. 7 is another aspect of an assembly with a fixing mechanism 710 according to the present disclosure that maintains the collection / waste tube 102 in a spaced-apart relationship from the adapter needle 158 during transportation and storage, and allows the collection / waste tube 102 to advance to engage with the needle 158 at the adapter 150 for sample collection. FIG. 7 shows an alternative foam friction fit collar 710 disposed around the collection / waste tube 102. The collar 710 does not have the flanges shown in FIGS. 5A-5D and FIG. 6. The collar 710 is configured with friction fit features described above with respect to the fixing mechanisms (e.g., fixing mechanisms 110, 510, etc.). In one aspect, the collar 710 is attached to the outside of the tube 102 (e.g., using a low-adhesion adhesive or one or more stickers as described below) to prevent accidental translation of the tube 102 before the user pushes the tube 102 into the adapter 150.

[0034] FIG. 8A shows an alternative mechanism that provides a friction fit for a flange / O-ring assembly that separates the waste tube from the adapter needle during transportation. In this aspect, the O-ring is disposed under the cap and has a friction fit within the adapter such that the waste tube is slidably engaged at the adapter. A sticker is provided to fix the waste tube in the transport position. The sticker is labeled as such.

[0035] FIG. 8B shows a modified cap or stopper with an O-ring disposed in a groove for slidable engagement of the cap at the adapter. The O-ring provides a friction fit at the adapter.

[0036] FIG. 8C shows a sample collection system comprising the cap of FIG. 8B and a sticker on a flange at the base of the adapter that fixes the collection / waste tube in a spaced-apart relationship from the adapter needle.

[0037] Figs. 9A-9I show the operation of the sample collection / waste tube in the adapter. The sample collection / waste tube is protected from engagement with the needle in the adapter during transportation, but is slidable so that the collection / waste tube engages with the needle for sample collection and is then removable from the adapter after sample collection, and a sleeve with a flange for receiving an O-ring is fitted.

[0038] Figures 10A and 10B are another aspect of an assembly with a fixing mechanism 1010 that maintains the collection / waste tube 102 at a spaced-apart relationship from the adapter needle 158 during transportation and storage, and allows the collection / waste tube 102 to advance to engage with the needle 158 at the adapter 150 for sample collection. In this regard, the aspect shown in Figures 10A and 10B is related to the aspect shown in Figures 13A and 13B. Figures 10A and 10B particularly show a ring as the fixing mechanism 1010. The ring 1010 can be formed from rubber. The rubber ring 1010 includes (annular) portions 1012, 1014. The portion 1014 has a predetermined outer diameter configured to provide an interference fit with the inner diameter of the lower end opening of the adapter 150. The inner diameter of the portion 1012 (defining the inner diameter of the ring 1010) is configured to snugly receive the collection tube 102 to ensure that the collection tube 102 remains in a spaced-apart relationship from the needle 158 at the adapter 150 during transportation. In one aspect, the portion 1012 projects distally from the portion 1014 and has a diameter that tapers distally. The portion 1012 is configured (through the inner diameter and shape of the portion 1012) such that by applying a pressing force, the tube 102 can be easily advanced in only one direction into the adapter 150 as shown in Figure 10B so that the collection / waste tube 102 can be advanced to engage with the needle 158 for sample collection. After sample collection, the rubber ring 1010 is detached from the engagement with the adapter 150. By applying a tensile force to the tube 102 to remove the tube 102 from the adapter 150, the portion 1012 grabs or captures the outside of the tube 102, separates the adapter 150 from the tube 102 at the ring 1010, and the ring 1010 is pulled out together from the adapter 150. The ring 1010 is configured as a one-way ratchet mechanism.

[0039] FIG. 11 shows a fixing mechanism 1110 which is an alternative configuration of the rubber ring 1010 of FIGS. 10A and 10B. The rubber ring or the fixing mechanism 1110 includes portions 1114 and 1112. The outer diameter of the ring 1110 is configured to provide an interference fit with the adapter 150 in the above-described manner. The portions 1112 and 1114 each include an inner diameter. The inner diameter of the portion 1112 is smaller than that of the portion 1114 and is selected to accommodate and grip the flange 1122 of the sleeve 1120 disposed on the tube 102 to hold the tube 102 in a spaced relationship from the needle 158 in the adapter 150. The tube 102 can be pushed into the adapter 150 to engage the needle 158. When the tube 102 is pulled out of the adapter 150, the flange 1122 engages the rubber ring 1110. When the collection / waste tube 102 is pulled out of and removed from the adapter 150, the rubber ring 1110 is pulled out of the adapter 150 by the flanged ring 1120.

[0040] FIG. 12 shows a fixing mechanism 1210 which is another alternative configuration of a rubber ring disposed at the bottom of an adapter 150 which is a variant of what was described in FIGS. 10A, 10B, and 11. In this aspect, the rubber ring 1210 has a bearing 1212 (e.g., a ball bearing) embedded in the inner circumference of the rubber ring 1210. The ring 1210 has an outer diameter and an inner diameter configured to hold the tube 102 in an interference fit with the adapter 150. In one aspect, the ring 1210 may include an inner ring 1214 that projects from the inner circumference of the ring 1210 toward the center of the central opening of the ring 1210. The ring 1214 is configured to grip the outside of the tube 102 to hold the tube 102 in place. By applying a pressing force to the tube 102 into the adapter 150, the ring 1210 and the bearing 1212 are configured to facilitate the advancement of the collection / disposal tube 102 so as to engage with the needle 158 in the adapter 150. In one aspect, the rubber ring 1210 is prevented from advancing into the adapter 150 by a flange or stepped end 1250 at the inner diameter of the open proximal end 154B of the adapter 150. The stepped end 1250 has an inner diameter that matches the outer diameter of the ring 1210. To prevent the ring 1210 from advancing into the adapter 150, the surface 1216 of the ring 1210 is in contact with the surface or ledge 1252 of the stepped end 1250. When the tube 102 is withdrawn or advanced from the adapter 150, the rubber ring 1210 is removed from the adapter 150. In one aspect, when the tube 102 is withdrawn from the adapter 150, the ring 1210 is configured to sandwich the ball bearing 1212 (by the surrounding material of the gripping ring 1214 and the ring 1212), so that the gripping force of the ring 1210 on the tube 102 is increased, the ring 1210 is separated from the adapter 150, and is withdrawn from the adapter 150 together with the tube 102.

[0041] Figures 13A and 13B show another aspect of an assembly with a securing mechanism 1310 that maintains the collection / waste tube 102 at a spaced-apart relationship from the adapter needle 158 during transport and storage and allows the collection / waste tube 102 to advance to engage the needle 158 at the adapter 150 for sample collection. Figures 13A and 13B show the securing mechanism as a ratchet collar 1310 with tabs 1312 extending from a flanged portion 1314. The tabs 1312 are spaced along the inner circumference of the collar 1310 and extend distally from the flanged portion 1314. The central opening of the collar 1310 receives the tube 102, and the tabs 1312 provide an interference fit for the collar 1310 at the adapter 150 and an interference fit with the tube 102, whereby the collection / waste tube can be advanced through the collar 1310. As shown in Figure 13A, at least a portion of each tab 1312 extends in a direction toward the center of the central opening of the collar 1310. The flanged portion 1314 of the collar 1310 contacts the open proximal end of the adapter 150 to hold the adapter 150 in place when the tube 102 is pushed into the adapter 150. As shown in Figure 13B, the collar 1310 remains in place when the tube 102 is advanced to engage the adapter needle 158. The collar 1310 allows the collection / waste tube 102 to freely advance toward the needle 158, but the tabs 1312 of the collar 1310 grip the outside of the tube 102 and are configured to bunch up on the outside of the tube 102 when the collection / waste tube 102 is pulled away from the needle 158. Thus, when the collection / waste tube 102 is pulled from the adapter 150, the collar 1310 is removed from the adapter 150. In one aspect, as shown in Figures 13A and 13B, the tabs 1312 can be supported by a ring or rim 1312 that extends distally from the flanged portion 1314. Alternative examples of this configuration are described in Figures 10A, 10B, 12, 14A-14D, 15A-15D, 16A-16E.This allows the color 1310 to enable the easy advancement of the tube 102 into the adapter 150, but is something like a one-way ratchet mechanism that captures and grips the tube 102 when the tube 102 is withdrawn.

[0042] Figures 14A - 14D are another aspect of an assembly with a securing mechanism 1410 that maintains the collection / waste tube 102 at a spaced - apart relationship from the adapter needle 158 during transport and storage, and allows the collection / waste tube 102 to advance to engage with the needle 158 at the adapter 150 for sample collection. Figures 14A - 14D are another alternative to Figures 13A and 13B. Figures 14A - 14D show a securing mechanism as a one - way collar 1410. The collar 1410 includes a tubular or barrel portion 1414 and a flanged portion. The collar 1410 includes an inner grip 1416 disposed on and projecting from the inner surface of the portion 1414. The grip 1416 provides a frictional force for gripping the outer side of the tube 102 when the tube 102 is received inside the portion 1414. The grip 1416 holds the tube 102 in a predetermined position (e.g., a spaced - apart relationship from the needle 158) and is configured to allow the collection / waste tube 102 to be advanced into the adapter 150 when a pressing force is applied to the tube 102. As shown in Figure 14D, the grip 1416 of the collar 1410 grips the tube 102 such that the tube 102 is removed from engagement with the adapter 150 when the collection / waste tube 102 is pulled out from the adapter 150. The flanged portion 1412 of the collar 1410 has a catch 1418 for receiving a flange at the base or open proximal end of the adapter 150. The catch 1418 may form all or part of the outer rim or outer perimeter of the flanged portion 1412. Since the grip 1416 grips the outer side of the tube 102, when the tube 102 is pulled out from the adapter 102, the sealing / attachment of the catch 1418 to the base of the adapter 150 is broken. The catch 1418 may be formed from a flexible material (TPE) so that it can break the sealing / attachment to the flanged base of the adapter 150 and disconnect from the adapter 150 when the tube 102 is pulled out from the adapter 150.

[0043] Figures 15A - 15D show an alternative securing mechanism 1510 for the color 1310 of FIGS. 13A and 13B and operate in a similar fashion. The one - way color 1510 in this aspect includes portions 1512 and 1514. Portion 1512 includes a detent or catch 1518 that engages the base of the adapter 150 in a fashion similar to that described above with respect to catch 1418. Thereby, in this aspect, the color 1510 does not have an interference fit with the adapter 150. Due to the bump - off 1520 at the detent 1518 on the color 1510, the color 1510 cannot advance upward into the adapter 150. The color 1510 includes a grip 1516 that extends upward (distal direction) from the inner wall of portion 1514 toward the center of the interior of portion 1514. The grip 1516 functions as a one - way ratchet mechanism in the tube 102. In use, the color 1510 is disposed around the tube 102, the grip 1516 holds the outside of the tube 102, and the detent 1518 engages the base of the adapter 1510 to hold the tube 102 in a spaced - apart relationship from the needle 158. The grip 1516 is configured to allow easy movement of the tube 102 to engage with the needle 158 toward the interior of the adapter 150 with a relatively small pressing force. Further, the grip 1516 is configured to bunch up when the tube 102 is pulled toward the outside of the adapter 150 and provide a high resistance or frictional force on the outside of the tube 102. An example of the operation and bunching that occurs for the grip 1516 is shown for a similarly configured grip 1616 in FIGS. 16B, 16C, and 16E - 16K. The grip 1516 holds the collection / discard tube 102 such that the detent 1518 is separated from the base of the adapter when the tube 102 is removed or pulled out from the adapter 150. Thus, pulling on the tube 102 removes both the color 1510 and the tube 102 from the adapter 150.

[0044] Figures 16A - 16D show an alternative fixing mechanism 1610 for the color shown in FIG. 15, with a sticker 1650 added to fix the color 1610 to the collection / waste tube 102 at the transport / storage position. The color 1610 includes portions 1612, 1614 configured with similar features to the portions 1512, 1514 described above. The bump-off and detent 1618 is rotated 90 degrees relative to that shown in FIGS. 15A - 15D.

[0045] Figures 16E - 16K show the operation of the assembly of FIGS. 16A - 16D. The upward grip 1618 allows the collection / waste tube 102 to be advanced upward into the adapter 150, but when the collection / waste tube 102 is advanced outward from the adapter 150, the collection / waste tube 102 carries the color 1610 with it out of the adapter 150. The tube 102 can be advanced upward through the grip, but the grip 1616 acts as a one-way grip such that the tube 102 carries the color 1610 when advanced outward from the adapter.

[0046] Figures 17A and 17B are two-piece fixing mechanisms. The fixing mechanism 1710 shown in Figures 17A and 17B includes collars 1711 and 1721. Variations of this embodiment are shown in Figures 18A - 18C and Figures 19A - 19C. Collar 1721 includes a base 1722 and a return 1724 that extends longitudinally from the base 1722 (i.e., the insertion direction of the tube 102 into the adapter 150 and the withdrawal direction of the tube 102 from the adapter 150). Collar 1722 is attached (e.g., adhered) to the outside of the collection / waste tube 102 by an interference fit. Collar 1711 forms an interference fit with the open base end of the adapter 150 and includes portions 1712, 1714 configured in a similar manner to the portions 512, 514 described above to prevent the collar 1711 from being further advanced into the adapter 150. The inner diameter of the collar 1711 provides an interference grip on the outside of the tube 102 to hold the tube 102 in a stationary position relative to the collar 1711 and the adapter 150 unless sufficient force is applied to the tube 102. Collar 1711 includes a hole 1716 configured to receive the return 1724. The tube 102 is held by the collar 1711 in a spaced relationship from the needle 158 during transportation and storage with the collar 1721 spaced from the collar 1711. When the tube 102 is pushed or advanced into engagement with the needle 158 within the adapter 105, the collar 1721 is advanced toward the collar 1711 and the return 1724 locks into the hole 1716 in the flanged adapter collar 1711 that is interference-fitted with the adapter base. The return 1724 of the collar 1722 locks into the opening 1716 in the flanged adapter collar 1711 to form a two-piece assembled collar. When the collection / waste tube 102 is advanced out of the adapter 150, the tube 102 carries the two-piece assembled collar (including collars 1711, 1721) away from the adapter 150.

[0047] Figures 18A - 18C show another fixing mechanism configured as a two - piece assembly that holds the collection / waste tube 102 in a spaced - apart arrangement from the needle 158 in the adapter 150 during transport, but allows the collection / waste tube 102 to be advanced into engagement with the needle 158 for sample collection. The two - piece assembly or fixing mechanism is withdrawn from the adapter 150 when the collection / waste tube 102 is removed from the adapter 150. The fixing mechanism includes a snap ring 1811, which comprises a ring portion 1814 and an upward - projecting portion or snap fin 1812 that projects from the ring portion 1814 and is biased to be angled inwardly towards the interior of the snap ring 1811. The snap ring 1811 is fitted to the open - end base of the adapter 150. The adapter 150 includes a stepped end 1828 for receiving the snap ring 1811. The fixing mechanism further includes a sleeve 1821 and projecting portions 1822 and 1823 configured to hold an O - ring 1825 between portions 1822 and 1823. The sleeve 1821 further includes a projecting portion or flange 1824. The sleeve 1821 is fitted to the collection - waste tube 102 (e.g., the sleeve 1821 can be adhered to the outside and / or the tube 102 or gripped on the outside of the tube 102 by a crush rib 1826). When the tube 102 is inserted into the adapter 150, the projection 1812 allows the projecting portions 1822, 1823 and the O - ring 1825 to pass through the snap ring 1811. The O - ring 1825 provides friction against the interior of the adapter 150 to hold the tube 102 in a spaced - apart relationship from the needle 158 during transport and / or storage. The projection 1812 of the snap ring 1811 signs against the outside of the sleeve 1821 and contacts the projecting portion 1823, thereby preventing the tube 102 from being withdrawn from the adapter 150. The tube 102 is pushed into the adapter 150 to engage the needle 158 for sample collection. During this engagement, the projection 1812 allows the projecting portion 1824 to pass through the snap ring 1811.When the tube 102 is withdrawn from the adapter 150, a flange or protruding portion 1824 on the sleeve 1821 captures the end of the protrusion 1812 and pulls the snap ring 1821 out of the adapter 150 when the collection / waste tube 102 is removed from the adapter 150.

[0048] Figures 19A - 19C are an alternative embodiment of the two - piece assembly in FIGS. 18A - 18C that holds the collection / waste tube 102 in a spaced - apart arrangement from the needle 158 in the adapter 150 during transport, but allows the collection / waste tube 102 to be advanced into engagement with the needle 158 for sample collection. The two - piece assembly or fixing mechanism is withdrawn from the adapter 150 when the collection / waste tube 102 is removed from the adapter 150. The fixing mechanism includes a snap ring 1911 and a sleeve 1921. The snap ring 1921 includes an upwardly projecting portion or snap fin 1912 that projects from a ring portion or base 1914 and is biased to be angled towards the inside of the snap ring 1911. The snap ring forms an interference fit in the collection / waste tube 102. The snap ring 1911 further includes a rib 1916 for gripping the inside of the adapter 150 and a flange 1915 formed on the base 1914 for contacting the rim of the open base end of the adapter 150. The snap ring 1911 is fitted into the base of the adapter 150 as shown, with the rib 1916 gripping the inside of the adapter 150 and the flange 1915 preventing the snap ring 1911 from being further advanced into the adapter 150. In this embodiment, the sleeve 1921 has first, second, and third flanges or projecting portions 1921, 1922, 1924 that project from the outside of the sleeve 1921. The sleeve 1921 further includes a rib 1926 that projects from the inner surface of the sleeve 1921 to grip the outside of the tube 102 when the sleeve 1921 is fitted onto the collection / waste tube 102 such that the sleeve 1921 and the tube 102 are fixed relative to each other. When the tube 102 is advanced into the adapter 150 for transport, the fin 1912 allows the first projecting portion 1922 to advance over the fin 1912, whereby the end of the fin 1912 is inserted between the projecting portions 1922 and 1923, locking the tube 102 and the sleeve 1921 in place for transport and storage with the tube 102 in a spaced - apart relationship from the needle 158.The inner surface of fin 1912 is positioned at this location relative to a part of the second flange or protruding portion 1923 and holds the collection / waste tube 102 in place for transportation or storage. When the collection / waste tube is in place at the second location, the beveled flange 1923 advances beyond the snap ring 1911. The fin 1912 allows the second and third protruding portions 1923 and 1924 to pass through the snap ring 1911 when the tube 102 is pushed into the adapter 150 such that the collection tube 102 is engaged with the needle 158 for sample collection. When the tube 102 is withdrawn from the adapter 150, the third flange or protruding portion 1924 on the sleeve 1921 captures the end of the protrusion 1912 and pulls the snap ring 1911 away from the adapter 150 when the collection / waste tube 102 is removed from the adapter 150.

[0049] FIG. 20 shows a collection / waste tube 102 having a securing mechanism 2010 disposed about the tube 102 that holds the collection / waste tube 102 in a spaced-apart arrangement from the needle 158 in the adapter 150 during transport, but allows the collection / waste tube 102 to be advanced to engage the needle 158 for sample collection. The securing mechanism 2010 includes a flanged sleeve having a portion 2012, 2014 coupled to a flanged portion and a sleeve 2016 extending from the flanged portion. The portions 2012, 2014 may be configured with the same features described above with respect to the portions 112, 114 of the securing mechanism 110 and the portions 512, 514 of the securing mechanism 510. Thereby, the portions 2012, 2014 of the securing mechanism 2010 provide an interference fit between the securing mechanism 2010 and the adapter 150. The flanged portion 2014 is engaged with the adapter 150 by an interference fit. A gap exists between the outer diameter of the collection / waste tube 102 and the inner diameter of the sleeve portion 2016, which allows for easy (or free) movement of the collection / waste tube 102 in the securing mechanism 2010 and into the adapter 150 by applying a pressing / tensile force to the tube 102. The portion 2014 has a diameter larger than the proximal end portion of the adapter 150 and prevents the securing mechanism 2010 from advancing into the adapter 150 beyond the open end of the adapter 150 when the collection / waste tube 102 is disposed in the adapter 150. The flanged sleeve portion 2016 is flexible. When the collection / waste tube 102 is advanced through the securing mechanism 2010 to engage the needle 158 in the adapter 150 for blood collection, the securing mechanism 2010 remains in place. A diametrical gap exists between the tube and the sleeve 2016, which allows for free movement of the tube in the sleeve 2016. When advancing the collection / waste tube 102 to engage the needle 158 in the adapter 150, the operator grasps a collar adjacent the bottom of the adapter 150.As indicated by arrow 2018, since sleeve 2016 is flexible, sleeve 2016 can assist in grasping collection / waste tube 102 when removed from adapter 150 (e.g., when grasped by an operator). When tube 102 is advanced into adapter 150 and engaged with needle 150, portion 2016 is dimensioned with sufficient length such that the only way to grasp tube 102 is by grasping sleeve 2016 (as indicated by arrow 2018). This forces the user to pull out fixation mechanism 2010 together with tube 102. When collection / waste tube 102 is pulled out from adapter 150, the interference fit between portion 2012 and adapter 150 is overcome and the flanged sleeve fixation mechanism 2010 (being grasped by the user) is removed together with collection / waste tube 102.

[0050] FIG. 21 shows a fixation mechanism 2110 including a two - part collar with portions 2112, 2114 that fit at the bottom of adapter 150 but do not advance within adapter 150, in the same format described above with respect to color in FIGS. 5A - 5D and FIG. 20. The first portions of collars 2112, 2114 at the base of adapter 150 cooperate with the collar on collection / waste tube 102 to hold collection / waste tube 102 in a spaced - apart relationship with needle 158 in adapter 102. The second portion 2116 of the collar on collection / waste tube 102 has an arm 2108 with a notched engagement member 2120 that advances beyond the first portion 2114 of the collar when collection / waste tube 102 is advanced into adapter 150. Thereby, the second portion 2116 of the collar is designed as an outer clip. When collection / waste tube 102 is removed from adapter 150 after sample collection, the engagement member 2120 of the second portion 2118 of the collar pulls the first portion 2114 of the collar from the base of adapter 150.

[0051] FIG. 22 shows another fixing mechanism 2210 configured as a flanged sleeve for the collection / waste tube 102, which is an alternative to that shown in FIG. 20. The fixing mechanism 2210 includes a flanged portion 2212 and a sleeve portion 2214. The flange 2212 locks to the flange at the base of the adapter 150 by a lip / backstop 2218 that fits onto the adapter base flange in the same form described above with respect to the flanged portion 4112 including the catch 1418 in FIGS. 14A-14D. Thereby, the fixing mechanism 2210 is fixed by a locking fit with the adapter 150 instead of an interference fit. The inner diameter of the fixing mechanism 2210 grips the outer diameter of the tube 102, and the collection / waste tube 102 is held in a spaced-apart arrangement from the needle 158 in the adapter 150 during transport by the fixing mechanism 2210. By advancing the collection / waste tube 102 through the fixing mechanism 2210, the collection / waste tube 102 advances to connect with the adapter needle 158. After the sample has been collected, the flexible flanged portion 2212 is separated from the flange at the base of the adapter 150, and the collection / waste tube 102 with the sleeve 2210 attached is removed from the adapter 150. In one aspect, the flanged portion 2212 forms a sealed unit with the adapter 150 to enhance sterilization when locked to the base of the adapter 150. In one aspect, the sleeved portion includes one or more openings 2216 to allow the operator to view the contents (e.g., the collected sample) within the tube 102.

[0052] Figures 23A - 23C show another fixing mechanism 2310 configured as a flanged sleeve which is an alternative to those shown in Figures 20 and 22. The fixing mechanism 2310 in this embodiment includes a flanged portion 2312 and a sleeve portion 2314. The flanged portion 2312 has a detent with a bump-off for locking to the base of the adapter 150 as previously described and shown. By compressing the (elastomeric) sleeve 2314 and applying a tensile force to pull it away from the adapter 150, the flanged sleeve 2310 is separated from the adapter 150, which separates the sleeve flange 2312 from the flange at the base of the adapter 150 when the collection / waste tube 102 is removed from the adapter 150. The sleeve 2314 provides a gripping surface for removing the collection / waste tube 102. There is a diametrical gap between the sleeve 2314 and the collection / waste tube 102. In one embodiment, part or all of the sleeve portion 2314 may be formed from a transparent elastomeric material so that the contents of the tube 102 are visible through the sleeve portion 2314. In one embodiment, the sleeve portion 2314 is attached to the collection / waste tube 102 by a shrink wrap or tape 2350 (shown in Figure 23C) during transportation. The shrink wrap or tape 2350 (in addition to the friction provided by the inside of the sleeve portion 2314) helps to ensure that the collection / waste tube 102 remains spaced from the needle 150 during transportation.

[0053] Figures 24A and 24B depict another fixing mechanism 2410, which represents another aspect of those shown in Figures 20 and 23A - 23C. The fixing mechanism 2410 includes a flanged portion 2412 and a sleeve portion 2414, which contain features similar to the flanged portions 2212, 2312 and the sleeve portions 2214, 2314 described above. The sleeve portion 2414 includes an opening 2416 to enable the user to view the contents of the tube 102. Each opening 2416 can be formed as a closed loop (Figure 24A) or a slot (Figure 24B). In one aspect, the fixing mechanism 2410 may include friction beads 2420 on the inner circumference of the fixing mechanism 2410 (e.g., the inner circumference of portion 2412) to add additional friction and assist in holding the tube 102 in a stationary position relative to the fixing mechanism 2410. Figures 24A and 24B show how the sleeve flange fixing mechanism 2410 attaches to the flange at the base of the adapter 150 to hold the collection / waste tube 102 at a position spaced from the adapter needle 150 during transportation. As described above, the tube 102 can be moved relative to the fixing mechanism 2410 and the adapter 150 by applying a pressing or pulling force into / from the adapter 150.

[0054] Figures 25A - 25C show another fixing mechanism 2510, which is another aspect of that shown in FIGS. 20, 23A - 23C, 24A and 24B. The fixing mechanism 2510 includes the same features as the fixing mechanism 2410 (i.e., a flanged portion and a sleeve portion with an opening). In this aspect, as shown in FIG. 25B, the fixing mechanism 2510 may include a tape or adhesive strip 2550 (e.g., U - shaped, L - shaped, etc.) attached to a part of the fixing mechanism 2510 (e.g., the sleeve portion) and a part of the tube 102 to assist in holding the tube 102 in a position stationary with respect to the fixing mechanism 2510 (and the adapter 150). The strip 2550 may be positioned and configured to contact the tube 102 through one of the openings in the fixing mechanism 2510. The fixing mechanism 2510 holds the tube 102 in a spaced - apart relationship from the needle 158 during transportation and allows the tube 102 to be moved relative to the fixing mechanism and the adapter 150 by applying a tensile or compressive force into / from the adapter 150. It should be recognized that after transportation and during use, the tensile and compressive forces in the tube 102 cause the strip 2550 to separate from the tube 102.

[0055] FIG. 26 shows a fixing mechanism 2610 configured as a collar for a collection / discard tube 102 having a folding section with a living hinge. The living hinge allows the collar to maintain the collection / discard tube in a spaced - apart relationship from the needle in the adapter during transportation, but when the collection / discard tube is advanced towards the needle for blood collection, the living hinge folds and allows the collection / discard tube to be advanced into contact with the adapter needle for blood collection. After collection, the collar is removed together with the collection / discard tube when the collection / discard tube is removed from the adapter.

[0056] Figures 27A and 27B illustrate another fixing mechanism 2710 and another embodiment of the collection / waste tube assembly. In this case, the collection / waste tube has a sleeve attached to the collection / waste tube by a twist-on / twist-off flange attached to a flange at the base of the adapter. As shown, the line set is in fluid communication with the adapter, and when the collection / waste tube is advanced such that the needle in the adapter penetrates a seal in the cap of the collection / waste tube, blood is drawn into the collection / waste tube. The collection / waste tube is advanced within the sleeve, and the sleeve remains fixed when locked to the flange of the adapter. When the sleeve is unscrewed from the adapter flange, the collection / waste tube is removed from the adapter.

[0057] Figure 28 illustrates another fixing mechanism 2810 and another embodiment of the collection / waste tube assembly that holds the collection / waste tube in a spaced relationship from the needle in the adapter during transport but allows the collection / waste tube to be advanced to engage the needle for sample collection. In this embodiment, the collection / waste tube has a sleeve that can be screwed onto the adapter. The base of the sleeve is provided with a flange that has helical splines that provide a friction fit when advancing into the adapter as shown. The flange limits how far the sleeve can advance. The sleeve holds the collection / waste tube in a spaced relationship from the needle during transport and storage. The collection / waste tube is twisted to advance the collection / waste tube within the sleeve. As shown, the line set is in fluid communication with the adapter, and when the collection / waste tube is advanced such that the needle in the adapter penetrates a seal in the cap of the collection / waste tube, blood is drawn into the collection / waste tube. After sample collection, the collection / waste tube is removed from the adapter.

[0058] Figures 29A - 29C show another fixing mechanism 2910, and a collection / waste tube 102 held in a spaced - apart relationship from the needle 158 in the adapter 150 during transport, but which allows the collection / waste tube 102 to be advanced to engage the needle 158 during sample collection, showing another aspect of the collection / waste tube assembly. The fixing mechanism 2910 has a collar 2912 and a flexible hinged spring ring 2914 attached to the collar 2912 by a hinge 2918. The ring 2918 is biased to an inclined or angled position relative to the collar 2912 by the hinge 2918. In one aspect, as shown in Figure 29A, the ring 2918 is biased to be inclined towards the inside of the collar 2912 and the inside of the adapter 150. In another embodiment, as shown in Figure 29C, the ring 2918 is biased to be inclined towards the outside of the collar 2912 and the outside of the adapter 150.

[0059] Color 2912 includes an outer diameter selected to fit (e.g., snugly) within the inner circumference at the open end of the base of adapter 150 in an interference fit. Fixing mechanism 2910 includes one or more tabs 2916 extending in a direction away from the outer circumference of color 2912. Tabs 2916 are configured to contact the circumference defining the opening at the end of the base of adapter 150 to prevent fixing mechanism 2910 from being further advanced into adapter 150 and to hold fixing mechanism 2910 in a predetermined position at the base of adapter 150. Flexible hinged spring ring 2912 is configured to receive tube 102 and grasp and hold the outside of collection / waste tube 102 in a spaced-apart relationship from needle 158 during transportation and storage. When ring 2914 is at a predetermined angle with respect to the base of the adapter and / or color 2912, the inner circumferential surface of ring 2914 contacts the collection / waste tube and grasps or locks the outside of tube 102. The grip is such that tube 102 is movable into and out of adapter 150 relative to fixing mechanism 2910 and adapter 150 by applying a tensile or compressive force to tube 102. Ring 2914 bends in the direction of tube movement. When tube 102 moves ring 2914 towards adapter 150, ring 2914 reduces or releases contact with collection / waste tube 102 and allows collection / waste tube 102 to advance. When the needle 158 in adapter 150 penetrates the seal in the cap of collection / waste tube 102 as collection / waste tube is advanced into contact with needle 158, blood is drawn into collection / waste tube 102. After sample collection, collection / waste tube 102 is removed from adapter 150 together with fixing mechanism 2910. When collection / waste tube 102 is pulled away from needle 158 in adapter 150, ring 2914 bends away from the holder and grasps or clamps collection / waste tube 102 more tightly. This locks ring 2914 to collection / waste tube 102 such that when collection / waste tube 102 is removed from adapter 150, collection / waste tube 102 pulls fixing mechanism 2910 along with collection / waste tube 102.

[0060] Figures 30A - 30C show another fixed mechanism 3010, and a two-piece collar / sleeve assembly for holding the collection / waste tube 102 in a spaced relationship to the needle 158 in the adapter 150 during transport and storage, but allowing the collection / waste tube 102 to be advanced to engage the needle 158 for sample collection. The fixed mechanism 3010 includes a collar 3011 and a sleeve 3021. The collar 3011 includes portions 3012 and 3014 configured in the same form as described above with respect to portions 512, 514 that provide an interference fit with the open end at the base of the adapter 150 and prevent the collar 3011 from being further advanced into the adapter 150. The collar 3011 includes a notched channel 3016 inside the collar 3011. The collar 3011 further includes a detent or protrusion 3017 extending from the inner surface of each notched channel 3016. The sleeve 3021 has a protruding guide 3023 that moves through the notch 3016 in the adapter collar 3011. Each protruding guide 3023 includes a stepped or protruding portion 3022. The sleeve 3021 includes a protruding tab 3024 that extends towards the outside of the sleeve 3021. The sleeve 3021 is fitted to the collection / waste tube 102. In one aspect, the sleeve 3021 is attached to the tube 102 via friction or grip between the inside of the sleeve 3021 and the outside of the tube 102, or via an adhesive applied between the inside of the sleeve 3021 and the outside of the tube 102. During transport and storage, the protruding portion 3022 remains behind the detent 3017, whereby the collection / waste tube 102 is maintained in a spaced relationship from the needle 158 in a fixed position and an additional pressing force is required to advance the tube 102 into the interior of the adapter 150. In one aspect, the protruding portion 3022 also has an interference fit with the inner surface of the notched channel 3016 to assist in holding the tube 102 in a fixed position unless a tensile or pressing force is applied to the tube 102.When the protruding portion 3022 is forced to bypass the detent 3017 by the force on the tube 102 and the collection / waste tube 102 is advanced to contact the needle 150, when the needle in the adapter 150 penetrates the seal in the cap of the collection / waste tube 102, blood is drawn into the collection / waste tube 102. The channel 3016 and the guide 3023 cooperate to provide a smooth linear motion to the tube 102. When the cap of the tube 102 is advanced into the adapter 150 to engage the needle 158, the tab 3024 is configured to bend inward in a direction toward the inside of the sleeve 3021 by being compressed by contact with the rims and the inner surfaces of the portions 3014 and 3012. When the tube 102 is pressed, the tab 3024 advances into the interior of the adapter 150 beyond the portion 3012, where, due to the natural biasing of the tab 3024, the tab 3024 bends outward or deflects back to its original position. After sample collection, the collection / waste tube 102 is pulled to remove the tube 102 from the adapter 150. When the tube 102 is pulled, the end of the tab 3024 contacts the rim defining the open end of the portion 3012 of the collar 3011, thereby transmitting the tensile force applied to the tube 102 to the collar 3011 and separating the collar 3011 from the adapter 150 and removing it together with the sleeve 3021 and the tube 102 when the collection / waste tube 102 is removed from the adapter 150.

[0061] Figures 31A and 31B show the fixing mechanism 3110, which is a modified version of that shown in Figures 30A - 30C. It should be recognized that the components of Figure 31A (i.e., 30XX and 31XX) with numbers similar to those of the components in Figures 30A - 30C are configured with the same features unless otherwise explicitly stated. The collar 3111 has a clip 3115 fixed to the flange at the base of the adapter 150 as described above in the previous embodiment. The inner surface of the collar 3111 includes a sloped or protruding portion 3019 that converges towards the center of the collar 3111. The clip 3115 and the protruding portion 3019 are configured as deflectable tabs, and the deflection of the first tab 3119 towards the outside of the collar 3111 in the arc causes the deflection of the first clip 3115 towards the inside of the collar 3111 in the arc movement. The same relationship also applies to the second end 3119 and the second clip 3115, etc. The arc movement is indicated by the dotted arrows in Figures 31A and 31B. The sleeve 3021 has a protruding guide 3121 that moves through the notch 3116 in the adapter collar 3111 and a detent 3117 that cooperates with the protruding portion 3122. The sleeve 3011 further includes a protruding portion 3125 corresponding to each pair of the clip 3115 and the tab 3119 that contacts the tab 3119 to cause the deflection of the clip 3115 as described later. The sleeve 3121 is fitted to the collection / waste tube 102. The sleeve has a protruding portion 3112 at the base of the sleeve 3112 that interacts with the detent 3117, ensuring that the collection / waste tube 102 is held in a spaced relationship from the needle 158 during transportation and storage. When the collection / waste tube 102 is advanced to contact the needle 102 by bypassing the detent 3117 and the needle 158 in the adapter 150 penetrates the seal in the cap of the collection / waste tube 102, blood is drawn into the collection / waste tube 102.When the tube 102 is advanced into the adapter 150 and engages the needle 158, the protruding portion 3125 deflects the protruding portion 3119, which results in the deflection of the clip 3115 as shown by the dotted lines and arrows in FIGS. 31A and 31B. When the clip 3115 is deflected in this manner, the clip 3115 separates from the flange at the base of the adapter 150. When the protruding portion 3125 deflects the protruding portion 3119, the portions 3125 and 3119 may form an interference fit such that when the collection / waste tube 102 is pulled out and removed from the adapter 150 after sample collection, the separated collar 3115 and sleeve 2131 of the clip 3115 are also removed from the adapter 150 along with the tube 102. The separated clip 3115 allows for withdrawal.

[0062] Figures 32A and 32B are a modified aspect of the assembly for holding the collection / waste tube 102 in a spaced-apart arrangement from the needle 158 in the adapter 150 during transport, but allowing the collection / waste tube 102 to be advanced to engage the needle 158 for sample collection. In this aspect, the fixing mechanism 3210 includes a ring or collar 3212 and a slot 3214 in the adapter 150. The collar 3212 is disposed on the collection / waste tube 102 and has posts 3212 that engage the slots 3214 in the adapter housing 150, respectively. Although a plurality of slots and posts are shown, it should be appreciated that in some aspects, one slot and one post may be used. The side slot 3214 includes portions 3215 and 3216. Portion 3215 extends along a longitudinal direction parallel to the insertion and extraction direction of the tube 102 into the adapter 150. Portion 3216 branches from portion 3215 in a direction transverse to the longitudinal direction. The portion 3215 of the slot is configured to receive the post 3213 and allows the collar and the tube 102 to advance longitudinally within the portion 3215 of the slot 3214. Portion 3216 is configured to receive the post 3213 to allow the collar 3212 (and the tube 102) to be rotated to a locked position (i.e., preventing longitudinal movement of the collar 3212 and the tube 102) that spaces the collection / waste tube 102 from the needle 158 during transport and storage. In one aspect, the portion 3216 of the slot 3214 includes a detent or protrusion 3217 that extends into the portion 3216 to lock the post 3213 to the portion 3215. The slot 3219 behind the detent 3217 allows the detent 3217 to move longitudinally when the post 3213 is formed to cross through the portion 3216 of the slot 3214 (e.g., by a torque force applied to the tube 102 by the user).To advance the collection / waste tube 102 to engage the adapter needle 158, the collection / waste tube 102 is rotated / twisted, whereby the post 3213 moves through the portion 3215 into the portion 3215 of the slot 3214. Then the tube 102 is pressed longitudinally, whereby the collar pin / post 3213 can move forward again along the slot portion 3215 in the adapter housing 150, enabling the post 3213 to move longitudinally through the portion 3215 until the tube 102 is advanced to engage the needle 158 in the adapter 150 for blood collection. After sample collection, the collection / waste tube 102 is removed from the adapter 150 by pulling the tube 102, whereby the post 3213 is pulled through the slot portion 3215 with the collar 3212 until the tube 102 and the collar 3212 are removed from the adapter 150. It should be appreciated that the collar 3212 can be fixedly coupled to the tube 102 or the tube 102 and the collar 3212 can have an interference fit or a friction fit with respect to each other such that they remain fixed relative to each other.

[0063] Figures 33A and 33B are modifications of the aspects of Figures 32A and 32B. The fixing mechanism in Figures 33A and 33B includes a collar 3312 and a slot 3314 in the adapter 150. The collar 3312 includes a post 3313 that is slidable in a slot 3314 including slot portions 3316, 3315. The slot portion 3315 extends longitudinally, and the slot portion 3316 branches in a direction transverse to the longitudinal direction. The collar 3312 disposed on the collection / waste tube 102 has a post 3313 that engages with the angled slot 3316 in the adapter housing 150. The side slot 3316 houses the follower pin / post 3313 on the collar 3312 and holds the collection / waste tube 102 in a spaced relationship to the needle 158 in the adapter 150. The slot portion 3316 is angled so as to prevent the tube 102 from being pulled out of the adapter 150 when the post 3313 remains at the closed end of the portion 3316. At the same time, since the slot portion 3316 is angled with respect to the portion 3315, when the operator advances the collection / waste tube 102 longitudinally, the follower pin / post 3313 is allowed to move through the detent and into the slot portion 3315 beyond the detent, thereby twisting the collection / waste tube 102 so that the follower pin / post 3313 is in the main vertical slot 3315. The pin 3313 in the slot 3315 allows the tube 102 to be advanced longitudinally into the adapter 150 so as to engage the needle 158. After sample collection, the collection / waste tube 102 is removed from the adapter 150 by the pulled tube 102. The tube 102 is removed together with the collar 3312. For removal of the collection / waste tube 102 from the collection / waste device 150, the follower pin / post 3313 moves along the vertical main slot 3315.

[0064] Figures 34A and 34B are modifications of the aspects of Figures 32A and 32B. The fixing mechanism 3410 in Figures 34A and 34B includes a collar 3412 with a post 3413 and a slot 3414 in the adapter housing 150. The slot 3414 is configured in a "U-turn" path, forcing the user to collect the sample in the collection / waste tube 102 before the tube 102 is removed from the adapter 150. The slot may include a detent or protrusion 3417. The configuration described herein that requires the collection / waste tube 102 to engage the needle 158 in the adapter 150 before the collection / waste tube 102 is removed from the adapter 150 is referred to herein as a forced compliance configuration. The collar 3412 disposed on the collection / waste tube 102 has a follower post 3413 that engages the slot 3414 in the adapter housing 150. The side slot allows the collar 3414 to be rotated to a locked position that locks the collection / waste tube 102 in a spaced relationship from the needle during transport and storage. The detent or protrusion 3417 may hold the post 3413 in the locked position. To advance the collection / waste tube 102 to engage the adapter needle 158, the collection / waste tube 102 is rotated, causing the post 3413 to also rotate past the detent 3417 and allowing the collar follower pin 3413 to advance again along the slot 3419 adjacent to the side slot in the adapter housing 150 so that the collar / collection / waste tube assembly can be advanced longitudinally to engage the needle 158 in the adapter 150 for blood collection (i.e., the post 3413 moves along the first longitudinal portion 3419 of the slot 3414 to the end of the portion 3419). After sample collection, the collection / waste tube 102 is rotated again and the collar pin 3413 moves along the waste slot longitudinal portion 3421, thereby removing the collection / waste tube 102 from the adapter 150 together with the collar 3412. To follow this path, the collection / waste tube 102 must be engaged with the needle 158 in the adapter 150.

[0065] Figures 35A and 35B are modifications of the embodiments of Figures 33A and 33B. The fixing mechanism 3510 in Figures 35A and 35B includes a collar 3511 and a sleeve 3521. The collar 3511 includes portions 3512 and 3514. Portion 3512 is configured to be received by the open base end of the adapter 150. Portion 3514 is configured to contact the flanged base of the adapter 150 to stop the fixing mechanism 3510 from being further advanced into the interior of the adapter 150. Portion 3512 includes pins or posts 3516, 3518. Post 3516 extends toward the interior of portion 3511, and post 3518 extends toward the outside of portion 3511. The posts 3516, 3518 are configured to be bent radially inwardly toward the center of the collar 3511. As will be described below, post 3516 controls the movement of the collection / waste tube 102 relative to the adapter 150.

[0066] The sleeve 3521 includes a ribbed interior (e.g., including ribs 3521 extending from the inner surface of the sleeve 3521 for gripping the tube 102). The ribbed sleeve 3521 fits snugly onto the collection / waste tube 102. When the portion 3512 is inserted into the adapter 150 and the portion 3514 contacts the adapter 150, the locking detent pin 3518 locks into and extends into the slot 3522 in the adapter 150, holding the collar 3511 in a fixed position relative to the adapter 150. The sleeve 3521 includes irregularities or slots 3527 on the outer surface of the sleeve 3521. The sleeve 3521 further includes a slot 3520 having a longitudinal portion 3523 and an angled portion 3525 branching from the portion 3523. The pin 3516 is slidably disposed in the slot 3520. When the collection / waste tube 102 is rotated such that the post 3516 engages the end of the angled slot 3525, this locks the collection / waste tube 102 in a spaced relationship from the needle 158 during transport and storage, preventing the tube 102 or collar 3511 from further advancing into the adapter 150 (i.e., by the pin 3516 contacting the closed end of the portion 3525). As shown in FIG. 35B, at this position, the irregularity slot 3527 on the outside of the sleeve 3521 is not aligned with the post 3518, and thus it is impossible for the fixing mechanism to release the adapter 150. To advance the collection / waste tube 102 to engage the adapter needle 158, the collection / waste tube 102 is pressed and rotated, and guided into the portion 3523 of the slot 3520 by the movement of the pin 3516 in the portion 3525, whereby the collar pin 3516 can advance again along the portion 3523 of the slot 3520 in the sleeve 3521 so that the collar / collection / waste tube assembly can be advanced to engage the needle 158 in the adapter 150 for blood collection.After sample collection, the collection / waste tube 102 is pulled and guided by the pin 3516 in the sleeve 3520, and the color pin 3516 is aligned with the slot 3520 in the sleeve 3521 so that the sleeve 3521 moves downward. When the collection waste tube 102 is removed from the adapter 150, the pin 3516 engages with the closed end (hard stop) of the portion 3523 of the slot 3520, the concave-convex slot 3527 is aligned with the pin 3518, and the pin 3518 bends radially inward to enable it to exit from the slot 3522 in the adapter 150. Thus, when the pin 3516 engages with the hard stop at the closed end of the portion 3523 of the slot 3520, the collar 3511 is not locked to the adapter 150 and is pulled out of the adapter 150 together with the tube 102.

[0067] Figures 36A and 36B are another aspect of an assembly with a fixing mechanism that maintains the collection / waste tube 102 in a spaced-apart relationship from the adapter needle 158 during transportation and storage and allows the collection / waste tube 102 to advance to engage with the needle 158 at the adapter 150 for sample collection. In this aspect, the fixing mechanism includes a collar 3612 and an insert 3614. The collar 3612 is disposed around the tube 102 and includes flexible fingers or posts 3616 that extend outwardly of the tube 102. The insert 3614 includes a barrel or tubular portion 3620 that is received inside the adapter 150. The insert 3614 further includes a flanged end 3618 that has a diameter larger than the inner diameter of the adapter 150 and thus prevents the insert 3618 from being further advanced into the adapter 150. The insert 3614 further includes a slot 3622 in the portion 3620. In this aspect, the adapter 150 includes a flexible or deflectable tab 3624 that is biased to tilt inwardly of the adapter 150 and is received by a corresponding slot 3622 of the insert 3614 to lock the insert 3614 in a stationary position relative to the adapter 150. When the assembly is transported or stored, the tube 102 and the collar 3612 are held in a spaced-apart relationship from the needle 158. In one aspect, the fingers 3616 are pushed into the inner surface of the insert 3614 so that the tube 102 is held in a spaced-apart relationship unless a force is applied. In one aspect, the insert 3614 includes a longitudinal groove 3613 in which the post 3616 moves or slides longitudinally when the tube 102 is pushed into the adapter 150. The collection / waste tube 102 can advance to engage with the needle 158 at the adapter 150. When the tube 102 is pushed into the adapter 150, the fingers 3616 enter the slot 3622, push the tab 3624 out of the slot 3622, and release the insert 3614 from a locked arrangement with the adapter 150.After sample collection, the collection / waste tube 102 is pulled and removed from the adapter 150, and the finger 3616 in the slot 3622 pulls the insert 3614 out of the adapter 150 together with the tube 102 and the collar 3612.

[0068] Figures 37A and 37B are another aspect of the assembly shown in Figures 36A and 36B, including a fixing mechanism that maintains the collection / waste tube 102 in a spaced-apart relationship from the adapter needle 158 during transportation and storage and allows the collection / waste tube 102 to advance to engage with the needle 158 at the adapter 150 for sample collection. In the illustrated aspect, the fixing mechanism has a sleeve 3714 with a bump-off 3717, a slot 3715, and a slot 3716. The fixing mechanism further includes a collar 3731 that includes a protruding portion 3732 and a flexible protrusion or fin 3734 biased to protrude at a predetermined angle towards the outside of the collar 3731. The collar 3731 includes ribs 3733 for gripping the outside of the tube 102 as shown. The sleeve 3714 is received in the adapter 150 as shown and includes a flanged end to prevent the sleeve 3731 from advancing further into the adapter 150 than shown. The adapter includes a flexible protrusion or fin 3724 biased to protrude towards the inside of the adapter 150. When the sleeve 3714 is inserted into the adapter 150, the protrusions 3724 extend into the ends of the respective slots 3716, capturing these ends and holding the sleeve 3714 in a locked position in the adapter 150. The collar 3731 grips the tube 102 as shown, and the tube 102 is inserted into the sleeve 3714, whereby the protrusion 3734 protrudes into the slot 3717 and captures the slot 3717, holding the tube 102 and the collar 3731 in a locked position, whereby the tube 102 is in a spaced-apart relationship from the needle 158 at the adapter 150. When the tube 102 is advanced into the adapter 150, the protruding portion 3716 is guided along the slot 3716, and the protrusion 3734 deflects inwards, releasing the collar 3731 from the locked position. Thereby, the collection / waste tube 102 can advance to engage with the needle 158 at the adapter 150. When the tube 102 engages with the needle 158, the protruding portion 3732 pushes the protrusion 3724 outwards from the slot 3716, thereby unlocking the sleeve 3714 from the adapter 150.Further, the protrusion 3734 extends into the slot 3715 and captures the closed end of the slot 3715, thereby locking the collar 3731 to the sleeve 3714. After sample collection, the collection / disposal tube 102 is removed from the adapter 150 together with the sleeve 3714 and the collar 3731 that are engaged at this point.

[0069] FIG. 38 is an aspect of FIGS. 37A and 37B, but instead of relying on the bump-out to lock the collection / disposal tube in a position spaced from the needle in the adapter during transportation and storage, it includes a tape or sticker 3850.

[0070] FIGS. 39A and 39B are another aspect of the assembly shown in FIGS. 36A and 36B that includes a fixing mechanism to maintain the collection / disposal tube 102 in a spaced relationship from the adapter needle 158 during transportation and storage and allow the collection / disposal tube 102 to advance to engage with the needle 158 in the adapter 150 for sample collection. In the illustrated aspect, the adapter has a sleeve with an elastic stop that allows the protrusion in the collar press-fitted to the collection / disposal tube to pass through the collection / disposal tube when a force is applied to advance the collection / disposal tube in the adapter. Thereby, a tape is applied to ensure that the collection / disposal tube is held in a desired spaced relationship from the adapter needle. When the tape is removed, the collection / disposal tube can advance to engage with the needle in the adapter. The collar also has a detent protrusion that moves along the guide in the adapter sleeve. At this point, the protrusion in the collar engages with the elastic stop. After sample collection, the collection / disposal tube is removed from the adapter together with the adapter sleeve engaged with the collar.

[0071] Figures 40A and 40B are another aspect of an assembly with a fixing mechanism that maintains the collection / waste tube 102 in a spaced-apart relationship from the adapter needle 158 during transportation and storage and allows the collection / waste tube 102 to advance to engage with the needle 158 at the adapter 150 for sample collection. In the illustrated aspect, the adapter includes a longitudinal sliding groove 4022 and a locking groove or slot 4020 disposed on the inner surface of the adapter 150. Further, the fixing mechanism includes a collar 4011 fixed or coupled to the outside of the tube 102. The collar 4011 includes a flexible finger or protrusion 4012 extending from a ring portion of the collar 4012. The flexible fingers 4012 on the collar 4012 extend into their respective locking grooves 4020, and the tube 102 is in a spaced-apart relationship from the needle 158 (i.e., not engaged with the needle 158) for storage and / or transportation, and the grooves 4020 and the flexible fingers 4012 prevent insertion / removal of the tube 102 into / from the adapter 150. The flexible fingers 4012 are configured to be depressed when the collar 4012 and the tube 102 are rotated. Thus, the fingers 4012 allow rotation of the tube 102, whereby rotation of the tube 102 causes the fingers 4012 to exit the locking grooves 4020 and enter the sliding groove 4022. When the collection / waste tube 102 is rotated and the fingers 4012 are positioned in the sliding groove 4022 of the adapter 150, the collection / waste tube 102 can be advanced to engage with the needle 158 at the adapter 150 while the fingers 4012 slide longitudinally in the sliding groove 4022 to allow advancement. After sample collection, the collection / waste tube 102 is removed from the adapter 150 by sliding the collection / waste tube 102 out while the flexible fingers 4012 slide along the sliding groove 4022.

[0072] Figure 41 is another aspect of an assembly with a fixing mechanism that maintains the collection / waste tube 102 in a spaced relationship from the adapter needle 158 during transportation and storage, and allows the collection / waste tube 102 to advance to engage with the needle 158 at the adapter 150 for sample collection. In this aspect, the fixing mechanism is configured such that the collection / waste tube 102 must be arranged in engagement with the needle 158 at the adapter 150 before the collection / waste tube 102 is removed from the adapter 150. Thus, this aspect is also a forced compliance configuration. In the illustrated aspect, the collection / waste tube 102 has a sleeve 4111 attached to the collection / waste tube 102, and a portion 4112 of the sleeve 4111 has a larger diameter than portion 4113. The sleeve 4111 has a flange at its proximal end that prevents the sleeve from being fully advanced into the adapter 150. The adapter 150 has a window 4122 cut into a side of the housing that holds a molded flexible component 4124 (e.g., a freely floating elliptical locking ring) in an elliptical configuration. The component 4124 is elliptical when in a rest state. The elliptical component 4124 holds the collection / waste tube 102 in a spaced relationship from the adapter needle 158. In this regard, in one aspect, the inner circumference of the ring 4124 along the minor axis (i.e., the apex of the minor axis) grips the outer surface of the sleeve 4111 at portion 4113 to hold the tube 102 in a spaced relationship (by friction). The larger diameter portion of the elliptical component 4124 projects into / out of the window 4122 at the base of the adapter 150, and this elliptical component 4124 locks the collection / waste tube 102 in place such that the collection / waste tube 102 is maintained in a spaced relationship from the needle 158 during transportation and storage. When the collection / waste tube 102 is pressed past the elliptical component 4124, the tube 102 can be advanced to contact the adapter needle 158 for sample collection.At that position, the wider portion 4112 of the sleeve 4111 changes the elliptical component 4124 configuration to circular (i.e., the outer surface of portion 4112 contacts the inner circumference at the minor axis or shorter diameter of the elliptical component 4124 and pushes out this inner circumference, changing the shape to circular), thereby pulling those portions of the elliptical component 4124 that extended out from the window 4122 at the base of the adapter 150 within the adapter 150. At this position, the component 4124 is held snugly by friction at the outer diameter of portion 4112. This shape change enables the collection / waste container 102 to be retracted from the adapter 150, carrying the component 4112 along with the tube 102 and sleeve 4111.

[0073] Figures 42A and 42B are another aspect of the assembly of FIG. 41 that includes a fixing mechanism that maintains the collection / waste tube 102 in a spaced-apart relationship from the adapter needle 158 during transportation and storage and allows the collection / waste tube 102 to advance to engage with the needle 158 at the adapter 150 for sample collection. In this aspect, before the collection / waste tube 102 is removed from the adapter 150, the collection / waste tube 102 must be arranged to engage with the needle 158 at the adapter 150. Thus, this aspect is also a forced compliance configuration. In the illustrated aspect, the collection / waste tube 102 has a sleeve 4211 attached to the collection / waste tube 102, and a portion 4212 of the sleeve 4211 has a diameter enlarged relative to portion 4213. The adapter 150 has a window 4222 that holds a flexible elliptical ring 4224 above a flange at the base of the adapter 150. The elliptical ring 4224 includes a tab or protrusion 4226 at the apex (maximum diameter) of the major axis of the elliptical ring 4224. The tab or protrusion 4226 is shaped to be received within the window 4222. The larger diameter portion of the elliptical component 4224 (i.e., the tab 4226) protrudes from the window 4222 at the base of the adapter 150, and the inner peripheral portion of the ring 4224 along the minor axis (i.e., the apex of the minor axis) extends into the window 4215 of the sleeve 4211. Thus, the elliptical component 4224 locks the collection / waste tube 102 in a predetermined position so that the collection / waste tube 102 is maintained in a spaced-apart relationship from the needle 158 during transportation and storage. The elliptical ring 4224 holds the collection / waste tube 102 in a spaced-apart relationship to the needle 158 at the adapter 150 (by engaging both windows 4222 and 4215). When the collection / waste tube 102 is pushed through the elliptical ring 4224 and into the interior of the adapter 150, the tube 102 can be advanced to contact the adapter needle 158 for sample collection.At that position, in the same format described above with respect to FIG. 41, the wider portion 4212 of the sleeve 4211 changes the elliptical ring 4224 configuration to circular, which pulls out from the window 4215 the tab 4226 that extended into the window 4222 at the base of the adapter 150 within the adapter 150 and the inner circumferential portion of the ring 4224 that extended into the window 4215. This shape change enables the collection / waste container 102 to be retracted from the adapter 150, carrying with it the ring component 4224 and the sleeve 4211.

[0074] Figures 43A and 43B are another aspect of an assembly with a securing mechanism that maintains the collection / waste tube in spaced relation from the adapter needle during transport and storage and allows the collection / waste tube to advance to engage the needle in the adapter for sample collection. In the illustrated aspect, the adapter has a threaded inner collar with a flange that contacts a flange at the base of the adapter. The collection / waste tube has a ring with a post. When the collection / waste tube is disposed within the adapter, the collection / waste tube is held away from the adapter needle. When sample collection is desired, the collection / waste tube is rotated, which advances the ring and threads the ring such that the ring post lands on a detent in the threaded inner collar. Once engaged, the sample is collected. After sample collection, the sample collection / waste tube is withdrawn from the adapter along with the ring and the threaded inner collar.

[0075] Figures 44A and 44B are alternative embodiments of Figures 43A and 43B and are another embodiment of an assembly with a securing mechanism that maintains the collection / waste tube 102 in a spaced-apart relationship from the adapter needle 158 during transport and storage and allows the collection / waste tube 102 to advance to engage the needle 158 at the adapter 150 for sample collection. In the illustrated embodiment, the securing mechanism includes a slotted inner collar 4111 with a flanged end, the flanged end contacting the flange at the base of the adapter 150 and preventing further insertion of the collar 4111 into the adapter 150. The barrel portion of the collar 4111 is inserted into the adapter 150. The slot 4413 of the collar 4111 has two detents 4415, 4415. The collection / waste tube has a ring 4431 attached to the collection / waste tube and comprising a post 4433 extending from the ring base. When the collection / waste tube 102 is positioned within the adapter 150, each post 4433 engages a respective first detent 4414 to hold the collection / waste tube 102 spaced from the adapter needle 158. When sample collection is desired, the collection / waste tube 102 is advanced into the adapter 150, whereby the ring post 4433 seats in the locking detent 4415 at the upper portion of the slot 4413. Upon engagement, a sample is collected into the collection / waste tube 102. After sample collection, the sample collection / waste tube 102 is withdrawn from the adapter 150 together with the ring 4431 and the slotted inner collar 4411.

[0076] Figures 45A and 45B are another aspect of an assembly with a securing mechanism that maintains the collection / waste tube spaced from the adapter needle during transport and storage and allows the collection / waste tube to advance to engage the needle in the adapter for sample collection. The adapter has two retaining holes in its housing proximal to the flange at the bottom of the adapter. The collection / waste tube has an inner sleeve. A collar is disposed on the sleeve. The collar has a first larger diameter, a second smaller diameter, and a distal flange of the cap of the collection / waste tube. The sleeve has outwardly extending fingers that fit into retaining holes in the collar when aligned with the retaining holes in the collar and hold the collection / waste tube away from the needle in the adapter for storage and handling. Retracting the collar releases the fingers from the holes. The collection / waste tube can then be advanced upward for sample collection or downward to remove the collection / waste tube from the adapter. After sample collection, the sample collection / waste tube is withdrawn from the adapter along with the sleeve and the fingers attached to the sleeve.

[0077] Figures 46A and 46B are another aspect of an assembly with a fixing mechanism that maintains the collection / waste tube at a spaced-apart relationship from the adapter needle during transportation and storage and allows the collection / waste tube to advance to engage with the needle in the adapter for sample collection. The adapter has two retaining holes in its housing proximal to the flange at the bottom of the adapter. The collection / waste tube has a flanged collar and a holder with fingers that extend upward and outward from the holder into the adapter. When the collar and the collection / waste tube are advanced into the adapter, the holes in the collar align with the holes in the adapter, and the fingers extending from the holder on the collection / waste tube lock the collection / waste tube in a position away from the needle in the adapter for storage and handling. Pulling the collar back releases the fingers from the holes in the adapter housing. The collection / waste tube is then advanced upward for sample collection. After sample collection, the sample collection / waste tube is withdrawn from the adapter together with the holder and the fingers attached to the holder.

[0078] Figures 47A and 47B show a diverter adapter that provides a first flow path for collecting a first portion of the sample to be collected and a second flow path for collecting a portion of the sample used for testing. The adapter has an inner sleeve that is retracted into the adapter when it is transported. The inner sleeve is pulled back and the post in the inner sleeve locks into the detent in the adapter housing, and the diverted portion of the sample is drawn into the upper chamber of the adapter through the first flow path in the adapter. After the diverted sample is collected, the inner sleeve is advanced upward, the adapter engages with the sample collection bottle, and the sample moves into the sample collection bottle through the second flow path.

[0079] Figures 48A and 48B show another aspect of an assembly with a securing mechanism that maintains the collection / waste tube spaced from the adapter needle during transport and storage and allows the collection / waste tube to advance to engage the needle in the adapter for sample collection. In this aspect, the collection / waste tube is fed into the adapter within the sleeve, and the sleeve has a flange at the distal end of the sleeve of the adapter needle. In a first position, when the collection / waste tube is held away from the adapter needle for transport and storage, the tape secures the sleeve in a position where the sleeve flange is spaced from the adapter flange at the adapter opening. When the sticker is peeled off, the collection / waste tube and the sleeve are further advanced into the adapter for sample collection. After sample collection, the sample collection / waste tube is withdrawn from the adapter together with the sleeve.

[0080] Figures 49A - 49F show different sticker configurations and arrangements that maintain the collection / waste tube 102 in a spaced - apart relationship from the adapter needle 158 during transportation and storage, and allow the collection / waste tube 102 to advance to engage with the needle 158 at the adapter 150 for sample collection upon removal of the sticker 4960. As shown, one or more stickers 4960 can be disposed on the proximal end portion of the adapter 150 and on a portion of the outside of the tube 102. The sticker arrangement and configuration are selected such that the tube 102 cannot be inadvertently pulled out of the adapter 150 or pushed into the adapter 150. The sticker 4960 holds the tube 102 in a predetermined position prior to use. Further, the sticker arrangement and configuration are such that when the tube 102 is pushed into the adapter 150, the portion of the sticker 4960 attached to the outside of the tube 102 is peeled off, or torn, or otherwise separated from the tube 102 (as shown in FIG. 49E) to allow the collection / waste tube to advance to a second position. In one aspect, when the tube 102 is pushed into the adapter 150, the perforation 4962 (or thinned section 4964) in the sticker is configured to tear or cut the sticker 4960 and allow the tube 102 to be pushed in to engage with the needle 158. As shown, the sticker 4960 can be of various shapes (e.g., capital - letter I - shape, rectangle, U - shape, Y - shape, etc.). The sticker can include a perforation 4962 or a thinner section 4964 to consistently assist in sticker tearing. The sticker 4960 is configured with appropriate characteristics such as sticker size, orientation, perforation 4962 (amount of perforation, perforation position, perforation depth, etc.) such that the sticker 4960 maintains a spaced - apart relationship and is peeled off from the tube 102 when the tube 102 is pushed into the adapter 150 for engagement with the needle 158.In one aspect, including one sticker on each side of the tube 102 and the adapter 150 maintains the alignment of the tube 102 within the adapter 105 with the needle 150 for engaging the tube 102 during insertion of the tube 102 into the adapter 150.

[0081] Figure 50 shows different sticker configurations and arrangements that maintain the collection / waste tube 102 spaced from the adapter needle 158 during transport and storage and allow the collection / waste tube 102 to advance to engage the needle 158 in the adapter 150 for sample collection upon removal of the sticker 4960. In this aspect, the securing mechanism for the collection / waste tube 102 has a collar 5011 (e.g., including the same features as the collar 510 and other similar collars described above), and the sticker 4960 maintains the separation of the collar 5011 from the adapter 150 and the separation of the tube 102 from the needle 158. The collar 5011 includes a blade 5012 configured to cut or sever the sticker 4960 into two separate pieces (e.g., in its central section, the section where perforations are formed, or a thinner section). When the sticker 4960 is cut, the collar 5011 can advance into the adapter 150 for sample collection. After sample collection, the collection / waste tube 102 is removed from the adapter 150 along with the collar 5011.

[0082] Figure 51 shows the use of a heat shrink material or wrap 5170 that maintains the collection / waste tube 102 in a spaced-apart relationship from the adapter needle 158 during transport and storage and allows the collection / waste tube 102 to advance to engage the needle 158 at the adapter 150 for sample collection upon removal of the heat shrink material. To advance the collection / waste tube 102 into the adapter 150, the heat shrink material 5170 is removed. The shrink wrap 5170 may include perforations (as will be described later with respect to wrap 5770) to facilitate easy cutting / splitting of the wrap 5170 and removal of the wrap 5170 to allow insertion of the tube 102 into the adapter 150. The wrap 5170 has the advantage of conforming to different shapes of the adapter 150, tube 102, fixing mechanisms, etc. that may be present in the assembly. After collection, the collection / waste tube 102 is removed from the adapter 150.

[0083] Figure 52 shows another aspect of an assembly with a fixing mechanism that maintains the collection / waste tube in a spaced-apart relationship from the adapter needle during transport and storage and allows the collection / waste tube to advance to engage the needle at the adapter for sample collection. In this aspect, the collection / waste tube is fed into the adapter within a sleeve having bellows at its end. The bellows serves to separate the collection / waste tube from the adapter needle during transport and storage. When sample collection is initiated, the collection / waste tube is pressed upward, folding the bellows and allowing the adapter needle to be inserted into the collection / waste tube for sample collection. When the desired amount of sample has been collected, the collection / waste tube and sleeve are removed from the adapter.

[0084] FIG. 53 shows another aspect of an assembly having a securing mechanism that maintains the collection / discard tube in a spaced relationship from the adapter needle during transport and storage and allows the collection / discard tube to advance to engage the needle in the adapter for sample collection. In this aspect, the collection / discard tube is fed into the adapter within a sleeve having a folded, corrugated portion. The folded corrugated portion serves to separate the collection / discard tube from the adapter needle during transport and storage. When sample collection is initiated, the corrugated portion expands, pressing the collection / discard tube upward and allowing the adapter needle to be inserted into the collection / discard tube for sample collection. When the desired amount of sample has been collected, the collection / discard tube and sleeve are removed from the adapter.

[0085] FIG. 54 is another aspect of the assembly described in FIG. 52. FIG. 54 shows an assembly having a securing mechanism that maintains the collection / discard tube in a spaced relationship from the adapter needle during transport and storage and allows the collection / discard tube to advance to engage the needle in the adapter for sample collection. In this aspect, the collection / discard tube is disposed within a sleeve having a bellows at its end adjacent a flange that prevents the bellows from entering the adapter. The bellows serves to separate the collection / discard tube from the adapter needle during transport and storage. When sample collection is initiated, the collection / discard tube is pressed upward, collapsing the bellows and allowing the adapter needle to be inserted into the collection / discard tube for sample collection. When the desired amount of sample has been collected, the collection / discard tube is removed from the adapter. The sleeve that did not enter the adapter remains on the collection / discard tube.

[0086] Figures 55A and 55B are another aspect of an assembly with a fixing mechanism that maintains the collection / waste tube at a spaced-apart relationship from the adapter needle during transportation and storage and allows the collection / waste tube to advance to engage with the needle in the adapter for sample collection. In this aspect, the collection / waste tube is disposed within a sleeve having a net disposed on the outside of the collection / waste tube. The creases in the net serve to separate the collection / waste tube from the adapter needle during transportation and storage. When sample collection is initiated, the collection / waste tube is pressed upward, allowing the creases to expand, thereby enabling the collection / waste tube to engage with the adapter needle, and thereby allowing the needle to be inserted into the collection / waste tube for sample collection. When the desired amount of sample has been collected, the collection / waste tube, along with the net, is removed from the adapter.

[0087] Figure 56 is another aspect of an assembly with a fixing mechanism that maintains the collection / waste tube at a spaced-apart relationship from the adapter needle during transportation and storage and allows the collection / waste tube to advance to engage with the needle in the adapter for sample collection. In this aspect, a stopper is disposed on the upper portion of the cap of the collection / waste tube. The stopper has a peripheral portion that forms a friction fit with the adapter when the stopper / collection / waste tube assembly is disposed within the adapter. The friction fit allows the stopper to maintain the collection / waste tube at a spaced-apart relationship from the adapter needle.

[0088] FIG. 57 is another aspect of an assembly that maintains the collection / waste tube 102 in a spaced-apart relationship from the adapter needle 158 during transport and storage, and allows the collection / waste tube 102 to advance to engage the needle 158 at the adapter 150 for sample collection. In this aspect, a removable clip 5750, a cut-away strip or sticker 5760, or a shrink wrap 5770 (disposed on the proximal end portion of the adapter 150 and at least a portion of the tube 102 and sleeve 5721) is used to enforce a spaced-apart relationship between the sleeve 5721 (configured with the same features as sleeve 5821 described later) in which the collection / waste tube 102 is disposed and the adapter 150. The shrink wrap 5770 may include a tear handle 5772 and a perforation (indicated by the dotted line) for tearing the shrink wrap 5770 of the assembly. The assembly may include any of the securing mechanisms described herein, and it should be recognized that the clip, sticker, or shrink wrap may be used in addition to or in place of the securing mechanism to maintain the spaced-apart relationship. The spaced-apart relationship ensures that the collection / waste tube 102 does not engage the adapter needle 158 during storage and transport. When sample collection is initiated, the clip 5750 or sticker 5760 is removed, and the sleeve in which the collection / waste tube is disposed can be advanced to contact the adapter needle 158 for sample collection. After sample collection, the collection / waste tube 102 (still disposed in the sleeve) is removed from the adapter.

[0089] Figures 58A - 58C are alternative embodiments of Figures 17A and 17B, Figures 18A - 18C, and Figures 19A - 19C. A fixing mechanism is shown that holds the collection / waste tube 102 in a spaced - apart relationship from the needle 158 in the adapter 150 during transportation, but allows the collection / waste tube 102 to be advanced to engage with the needle 158 for sample collection. When the collection / waste tube 102 is removed from the adapter 150, the three - piece assembly is pulled out from the adapter 150. The fixing mechanism includes a snap ring 5811, a sleeve 5821, and a ring 5831. The snap ring 5821 includes an upwardly projecting portion 5812 that extends for the ring base 5814 and is biased to be angled toward the inside of the snap ring 5811. The outer diameter of the ring base 5814 is fitted to fit snugly into the base open end portion of the adapter 150. The sleeve 5821 in this embodiment is tubular in configuration with an open end that houses a portion of the tube 102 and a closed end 5825. In one embodiment, the sleeve 5821 is fixed to the tube 102 (e.g., by an adhesive). The sleeve 5821 includes first and second flanges or protruding portions 5822 and 5824. The collar or ring 5831 is disposed adjacent to the cap 5831 on the collection waste tube 102. The collar 5831 is dimensioned to be advanced through the snap ring 5811 and above the snap ring 5811 and to be able to pass through the projecting portion 5812. The outer diameter of the collar 5831 can be configured to grip the inside of the adapter 150 to hold the collection / waste tube 102 spaced from the adapter needle 158 during transportation and storage. Additionally and / or alternatively, the projecting portion 5812 grips the outside of the tube 102 to hold the tube 102. In one embodiment, the adapter 150 includes a stepped end at the base to accommodate the snap ring 5811. The collar 5831 contacts the end of the projecting portion 5812, thereby preventing the tube 102 from being easily pulled out from the adapter 150 and holding it in a spaced - apart relationship from the needle 158.The tube 102 may be further pushed into the adapter 150. The protrusion 5812 allows the protruding portion 5822 to pass through the snap ring 5811. The protrusion snap-engages outside the sleeve 5821 in the region between the protruding portions 5822 and 5824. In this position, the snap ring 5811 and the sleeve 5831 are locked to each other, and the protrusion 5812 prevents the tube 102 from being easily pulled out of the adapter 150. Further, in this position, the collection tube 102 is engaged with the needle 158 for sample collection. When the collection / waste tube 102 and the sleeve 5821 are removed from the adapter 150, the first flange 5822 on the sleeve 5821 captures the end of the protrusion 5812 when the tube 102 is pulled out of the adapter 150 to pull the snap ring 5811 out of the adapter 150. In one aspect, as shown in FIG. 58C, when the assembly is stored or transported, a removable clip 5850 (e.g., configured with the same features as the clip 5750) is disposed around the tube 102 between the open end of the sleeve 5821 and the collar 5831 that contacts the base of the adapter 150 and the sleeve 5831. The clip 5850 prevents the tube 102 from being pushed too far into the adapter 150 too quickly, and the ring 5831 that contacts the snap ring 5811 prevents the tube 102 from being pulled out of the adapter 150. Thus, the tube 102 is held in a spaced relationship from the needle 158.

[0090] FIG. 59 is a conceptual proof-of-concept diagram using an elastomer tube that holds the collection / waste tube in a spaced relationship from the needle in the adapter during transport, but allows the collection / waste tube to be advanced to engage with the needle for sample collection. When the elastomer tube is removed, the collection / waste tube can be engaged with the adapter needle for sample collection. When the desired amount of sample has been collected, the collection / waste tube is removed from the adapter.

[0091] Figure 60 shows an extension (formed from any suitable material) from a sleeve on a collection / waste tube that holds the collection / waste tube in a spaced relationship from the needle in the adapter during transport, but allows the collection / waste tube to be advanced to engage the needle for sample collection. When the collection / waste tube is advanced to engage the adapter needle for sample collection, the extension is carried into the adapter. When the collection / waste tube is removed from the adapter, the extension is carried with the collection / waste tube.

[0092] Figure 61 is a further modification of the embodiment shown in Figure 60 and is also a proof-of-concept diagram using an extension from a sleeve on a collection / waste tube that holds the collection / waste tube in a spaced relationship from the needle in the adapter during transport, but allows the collection / waste tube to be advanced to engage the needle for sample collection. Tape is used to hold the sleeves together. In some embodiments, the cardboard is corrugated for additional thickness and robustness. When the collection / waste tube is advanced to engage the adapter needle for sample collection, the extension is carried into the adapter. When the collection / waste tube is removed from the adapter, the extension is carried with the collection / waste tube.

[0093] Figure 62 is a further modification of the embodiment shown in Figure 60 and is a proof-of-concept diagram using an extension from a sleeve on the collection / disposal tube that holds the collection / disposal tube in a spaced relationship from the needle in the adapter during transport but allows the collection / disposal tube to be advanced to engage the needle for sample collection. Tape is used to hold the sleeves together and to hold the collection / disposal tube in a spaced relationship to the adapter needle. In some embodiments, the cardboard is corrugated for additional thickness and strength. When collection is initiated, the tape that holds the collection / disposal tube in place is removed, allowing the collection / disposal tube to be advanced to engage the adapter for sample collection and the extension to be carried into the adapter. When the collection / disposal tube is removed from the adapter, the extension is carried with the collection / disposal tube.

[0094] Figure 63 is a conceptual diagram of a sleeve structure for a collection / disposal tube that is wide enough not to enter the adapter, thereby maintaining the collection / disposal tube in a spaced relationship from the needle in the adapter during transport but allowing the collection / disposal tube to be advanced to engage the needle for sample collection. The collection / disposal tube can be advanced within the sleeve structure. After sample collection, the structure is compressed so that the collection / disposal tube attached to the sleeve can be retracted from the adapter.

[0095] Figure 64 is a conceptual diagram of a sleeve structure for a collection / disposal tube that is wide enough not to enter the adapter, thereby maintaining the collection / disposal tube in a spaced relationship from the needle in the adapter during transport but allowing the collection / disposal tube to be advanced to engage the needle for sample collection when the sleeve is compressed. The collection / disposal tube can then be advanced within the sleeve structure. After sample collection, the structure is compressed so that the collection / disposal tube attached to the sleeve can be retracted from the adapter.

[0096] Figures 65A and 65B are an assembly comprising a valve having a first adapter for accommodating a collection / waste tube and at least one other adapter for accommodating a sample bottle. The assembly has an inlet that can be connected to a line set for collecting a sample from a patient. The valve can direct a first portion of the collected sample into the collection / waste tube. When a desired amount of sample has been collected, the valve is rotated and additional sample is directed to one or more sample containers.

[0097] Figure 66 is an alternative embodiment of that described in Figures 65A and 65B. In this embodiment, a pin is provided to prevent the valve from rotating beyond a position where the sample is directed beyond the sample collection / waste tube adapter unless the collection / waste tube is engaged with the needle in the adapter.

[0098] Figures 67A and 67B show alternative embodiments of the assembly described herein that deploy a collection / waste tube in communication with an adapter for connection to a patient line set for collecting a sample from a patient into a container. In this embodiment, the collection / waste tube is attached to the adapter but is held in a spaced relationship from the adapter needle during transport and storage. The collection / waste tube can have one of a number of examples of the colors or sleeves or tapes described herein to maintain such a spaced relationship between the collection / waste tube and the needle. The adapter has a valve at an end of the adapter arranged to connect with a patient line set (not shown). The collection / waste tube is advanced into the adapter to collect a sample, and then the valve is opened. When an initial portion of the patient sample is collected in the collection / waste tube, the collection / waste tube is removed from the adapter, and then a patient sample collection bottle is arranged in fluid communication with the adapter needle to collect the patient sample into a blood culture container.

[0099] Figures 68A and 68B show alternative embodiments of the assembly described herein that deploy a collection / discard tube in communication with an adapter for connection to a patient line set to collect a sample from a patient into a container. In this embodiment, the collection / discard tube is attached to the adapter but is held in a spaced relationship from the adapter needle during transport and storage by a rotating flap. The adapter has a first port for receiving the collection / discard tube and a second port for receiving a blood culture bottle. The flap is intermediate the collection / discard tube and the adapter needle and moves from a first position that prevents the collection / discard tube from contacting the adapter needle during transport and storage to a second position where the flap is positioned alongside the collection / discard tube and thus out of the way between the collection / discard tube and the adapter needle. Advancing the collection / discard tube in the adapter causes the flap to move from the first position to the second position. The collection / discard tube is advanced into the adapter to collect a sample and then the valve is opened. When an initial portion of the patient sample is collected in the collection / discard tube, the collection / discard tube is removed from the adapter and then a patient sample collection bottle is placed in fluid communication with the adapter needle at a larger port for collecting the patient sample into a blood culture container.

[0100] Figures 69A and 69B show alternative embodiments of the dual port adapter described in Figures 68A and 68B. The assemblies described herein deploy a collection / waste tube in communication with the dual port adapter for connection to a patient line set to collect a sample from a patient into a container. The collection / waste tube fits into only one of the dual ports. In this embodiment, the collection / waste tube is attached to the adapter but is held spaced from the adapter needle during transport and storage by the ring or other mechanism described herein. The adapter has a first port for receiving the collection / waste tube and a second port for receiving a blood culture bottle. The adapter also has a lever / pin assembly with a first position and a second position. In the first position, the lever at the port receiving the collection / waste tube is positioned over the pin at the second port. In this position, the pin cannot move upward and the culture bottle cannot be brought into contact with the needle at the second port. When the collection / waste tube is advanced so as to be in fluid communication with the needle in the adapter, the lever moves away from over the pin and the pin can move upward, allowing the culture bottle to be positioned in fluid communication with the needle at the second port for the remainder of the sample collection. When an initial portion of the patient sample is collected in the collection / waste tube, the collection / waste tube is removed from the adapter and then a patient sample collection bottle is positioned in fluid communication with the adapter needle at a larger port for collecting the patient sample into the blood culture container.

[0101] Figures 70A and 70B show alternative embodiments of the dual port adapter described in Figures 69A and 69B. The assemblies described herein deploy a collection / waste tube in communication with a dual port adapter for connection to a patient line set to collect a sample from a patient into a container. The collection / waste tube fits into only one of the dual ports. In this embodiment, the collection / waste tube is attached to the adapter but is held in a spaced relationship from the adapter needle during transport and storage by the ring or other mechanism described herein. The adapter has a first port for receiving the collection / waste tube and a second port for receiving a blood culture bottle. The adapter also has a needle shuttle for moving the needle from the first port to the second port. A lockout peg prevents the needle from being moved from the first port to the second port until a sample is collected into the collection / waste tube at the first port. When the collection / waste tube is advanced into fluid communication with the needle in the adapter, the lockout peg is moved upward, which enables the needle shuttle to be moved. Moving the needle shuttle moves the needle from the first port to the second port. A culture bottle can then be placed in fluid communication with the needle at the second port to collect the remainder of the sample. When an initial portion of the patient sample is collected into the collection / waste tube, the collection / waste tube is removed from the adapter and then a patient sample collection bottle is placed in fluid communication with the adapter needle at a larger port to collect the patient sample into a blood culture container.

[0102] FIG. 71 shows an alternative embodiment of the dual port adapter described in FIGS. 70A and 70B. The assembly described herein deploys a collection / waste tube in communication with the dual port adapter for connection to a patient line set to collect a sample from a patient into a container. The collection / waste tube fits into only one of the dual ports. In this embodiment, the collection / waste tube is attached to the adapter but is held in a spaced relationship from the adapter needle during transport and storage by the ring or other mechanism described herein. The adapter has a first port for receiving the collection / waste tube and a second port for receiving a blood culture bottle. The adapter also has a needle shuttle for moving the needle from the first port to the second port. In this embodiment, the assembly lacks a lockout peg. When an initial portion of the patient sample is collected into the collection / waste tube, the collection / waste tube is removed from the adapter, which allows the needle shuttle to be moved from the first port to the second port. The patient sample collection bottle is then placed in fluid communication with the adapter needle at the larger port to collect the patient sample into the blood culture container. By moving the needle shuttle, the needle moves from the first port to the second port. The culture bottle can then be placed in fluid communication with the needle at the second port for collection of the remainder of the sample.

[0103] Figures 72A and 72B show alternative embodiments of the dual port adapter. The assemblies described herein deploy a collection / waste tube in communication with the dual port adapter for connection to a patient line set to collect a sample from a patient into a container. The collection / waste tube fits into only one of the dual ports. In this embodiment, the collection / waste tube is attached to the adapter but is held in a spaced-apart relationship from the adapter needle during transport and storage by the ring or other mechanism described herein. The adapter has a first port for receiving the collection / waste tube and a second port for receiving a blood culture bottle. The adapter also has a rotary valve that allows a patient sample to flow into the collection / waste tube at one position and into the blood culture bottle at a second position. Initially, before the sample is collected, the rotary valve is in a third position ("off" position). When the collection / waste tube is placed in fluid communication with the needle in the adapter, the rotary valve is moved to the first position. When an initial portion of the patient sample is collected into the collection / waste tube, the collection / waste tube is removed from the adapter and the valve is moved to the third position, which allows the patient sample to be collected into the blood culture container when the blood culture bottle is placed in fluid communication with the adapter needle.

[0104] Figure 73 is an alternative embodiment to Figures 72A and 72B, where the adapter has a locking pin that requires the blood culture bottle to be inserted into the adapter before the rotary valve can be moved to the third position.

[0105] Figures 74A and 74B show alternative embodiments of the dual port adapter. The assemblies described herein deploy a collection / waste tube in communication with the dual port adapter for connection to a patient line set to collect a sample from a patient into a container. The collection / waste tube fits into only one of the dual ports. In this embodiment, the collection / waste tube is attached to the adapter but is held in a spaced relationship from the adapter needle during transport and storage by a ring or other mechanism described herein. The adapter has a first port for receiving the collection / waste tube and a second port for receiving a blood culture bottle. The ports are offset so that the collection / waste tube can be placed in one port and the culture bottle can be placed in the other port simultaneously, providing a differential pressure between the flow path to the collection / waste tube and the flow path to the culture bottle. When the collection / waste tube is placed in fluid communication with the needle in the adapter, a sample is collected into the sample collection / waste tube. When an initial portion of the patient sample is collected into the collection / waste tube, the blood culture bottle is placed in fluid communication with the needle in the second port. Since the second port is lower than the first port (or more precisely, since the sample collection tube is held higher in the adapter than the blood culture container), when both the collection / waste tube and the culture bottle are connected to the adapter, the sample preferentially flows into the blood culture container.

[0106] Figure 75 is an embodiment of a dual port adapter in which a sample collection / waste tube is held in a spaced relationship from the needle in the adapter by various mechanisms described herein, such as a rubber ring, clutch, sticker, or other separation mechanism. Figure 75 shows an encompassing separation mechanism integrated with the sliding needle shuttle described in Figure 71.

[0107] Figure 76 shows an adapter in fluid communication with a sample collection / waste tube. The adapter has a piezoelectric flow meter that indicates to the user when the sample collection waste tube contains a target amount of sample.

[0108] Figure 77 shows an alternative embodiment of a two-port adapter. Each port is attached to the end of a "Y" connector. The port for accommodating the sample collection / waste tube has a holding mechanism that maintains the sample collection / waste tube in a spaced relationship from the needle in the adapter during transportation and storage. When the sample collection / waste tube is brought into fluid communication with the needle in the port of the adapter, a line from the line set to the "Y" connector is prepared. The sleeve on the needle in the second port acts like a shut-off valve when a sample is being collected into the sample collection / waste tube. When a culture bottle is placed in fluid communication with the needle in the second port of the adapter, the sample preferentially flows into the culture bottle.

[0109] Figure 78 is an alternative embodiment of the two-port adapter of Figure 77. Each port is attached to the end of a "Y" connector and the port itself is arranged in a "Y". The port for accommodating the sample collection / waste tube may have a holding mechanism that maintains the sample collection / waste tube in a spaced relationship from the needle in the adapter during transportation and storage. When the sample collection / waste tube is brought into fluid communication with the needle in the adapter port, a line from the line set to the "Y" connector is prepared. The sleeve on the needle in the second port acts like a shut-off valve when a sample is being collected into the sample collection / waste tube. When a culture bottle is placed in fluid communication with the needle in the second port of the adapter, since the collection / waste tube has the required amount of sample therein, the sample preferentially flows into the culture bottle.

[0110] A sample collection system is described herein. In one aspect, the sample collection system includes a container for collecting a sample and an adapter including a distal end, a proximal end, a needle, and an interior. The adapter is configured to receive the sample through a connector at the distal end. The needle extends from the connector into the interior of the adapter, and the proximal end includes an opening for receiving a first end of the container into the interior of the adapter. The system also includes a fixing mechanism configured to releasably fix the container in a first position, in which the first end of the container is held in a spaced-apart relationship from the needle within the interior of the adapter. In one aspect, the fixing mechanism is operative to allow the container to be advanced distally within the adapter from the first position to a second position, thereby enabling engagement with the needle for receiving the sample into the container. In one aspect, the fixing mechanism is further configured to allow the container to be withdrawn proximally to remove the container from within the adapter. In a further aspect, when the container is removed from within the adapter, the fixing mechanism is configured to be removed by the container.

[0111] In one aspect, the fixing mechanism includes a collar fitted over the container. In a further aspect, the collar has an inner diameter larger than the outer diameter of the container and an outer diameter smaller than the inner diameter of the adapter. In a further aspect, the collar provides an interference fit when advanced into the adapter. In a further aspect, the collar has a flange that prevents the collar from being fully advanced into the adapter.

[0112] In another aspect, the fixing mechanism is a c-clamp. The fixing mechanism may also have an elastic gasket received over the container and forming an interference fit for the container within the adapter.

[0113] In another aspect, the container has a cap that may have a diaphragm and a shield. The shield may extend from the diaphragm and surround a portion of the outer periphery of the container. In a further aspect, the above-described shield may have a first O-ring at the proximal end and a second O-ring at the distal end, and each O-ring provides an interference fit when within the adapter.

[0114] In another aspect, the fixing mechanism is a collar on the container that forms an interference fit with the base of the shield in the adapter, and the fixing mechanism provides an interference fit in the adapter when advanced into the adapter. In a further aspect, the collar has a flange at the proximal end of the collar to prevent the collar from advancing completely into the adapter.

[0115] In another aspect, the adapter has a spring inside the adapter, and the spring provides resistance when the container is advanced into the adapter and engages the needle, and the spring is biased to advance the container out of the adapter after sample collection.

[0116] In another aspect of the sample collection system, the fixing mechanism is a foam rubber collar with a flange disposed on the container that forms an interference fit with the adapter when advanced into the adapter, and the flange has a diameter larger than the inner diameter of the adapter to prevent the flange-attached collar from being advanced completely into the adapter.

[0117] In another aspect of the sample collection system, the fixing mechanism is a foam rubber collar disposed on the container that seats within a flanged opening at the proximal end of the adapter, and the foam rubber collar forms an interference fit with the container but allows the container to be advanced through and withdrawn from the collar.

[0118] In another aspect of the sample collection system, the fixing mechanism is a foam rubber collar fixed to the container that forms an interference fit when introduced into the adapter. In a further aspect, the foam rubber collar is fixed to the container by an adhesive.

[0119] In another aspect of the sample collection system, the fixing mechanism may be a flanged O-ring collar on the container, the O-ring forming a friction fit in the adapter when the container is advanced in the adapter, and the flange not advancing into the adapter. In this aspect, the container is movably received at the flanged portion.

[0120] In another aspect, a method for collecting a sample from a patient is described herein, the method comprising providing a sample collection system as described above, operating the fixing mechanism of the sample collection system to enable the container to be advanced so as to be in fluid communication with the needle in the adapter, collecting the sample into the container, and removing the container from the adapter.

[0121] In another aspect, a sample collection system is described, comprising a container for collecting a sample, and an adapter including a distal end, a proximal end, a needle and an interior, the adapter being configured to receive the sample through a connector at the distal end, the needle extending from the connector into the interior of the adapter, the proximal end including an opening for receiving a first end of the container into the interior of the adapter, the adapter, and a fixing mechanism configured to hold the container in a first position, in which first position the first end of the container is held in a spaced relationship from the needle in the interior of the adapter. In the above aspect, the fixing mechanism is configured such that the container is advanced distally from the first position to a second position within the adapter, thereby enabling engagement with the needle to receive the sample into the container, and the fixing mechanism is further configured to enable the container to be withdrawn proximally to remove the container from the interior of the adapter. Optionally, when the container is removed from the interior of the adapter, the fixing mechanism is configured to be pulled by the container.

[0122] In another aspect, the fixing mechanism is formed of rubber and has an annular shape. The fixing mechanism is disposed around the outside of the container. The fixing mechanism has a distal portion that includes a thickness that fits between the container and the adapter, and a proximal portion that includes a flange having a diameter that exceeds the inner diameter of the adapter.

[0123] In another aspect, the fixing mechanism provides a snap fit with a shield for the container. The fixing mechanism includes a rim that extends in a direction away from the container and provides a stop that prevents the fixing mechanism from being further advanced into the adapter.

[0124] In another aspect, the fixing mechanism includes a compressible spring attached to the distal end of the container. The compressible spring is configured to be inserted between the container and the adapter. The compressible spring holds the container in a first position, but allows the container to be advanced to a second position when the tension provided by the spring is overcome.

[0125] In another aspect, the fixing mechanism includes a foamed rubber flange that provides an interference fit in the container. The container can be advanced from a first position to a second position by applying a force at the foamed rubber flange. A first portion of the foamed rubber flange can be advanced into the adapter, but a second portion of the foamed rubber flange is too large to be advanced into the adapter.

[0126] In another aspect, the fixing mechanism is a foamed rubber flange fixed to a corresponding flange by adhesion at the base of the adapter.

[0127] In another aspect, the fixing mechanism is a collar. The collar forms a friction fit with the container such that the collar cannot be advanced into the adapter, but the container can be advanced from a first position to a second position through the collar.

[0128] In another aspect, the fixing mechanism is an O-ring fixed on the container by a flange formed on the container.

[0129] In another aspect, a removable sticker is attached to the adapter and the container to fix the container in the first position.

[0130] In another aspect, the fixing mechanism is a collar that holds an O-ring forming an interference fit between the container and the adapter, and the collar is disposed adjacent to a cap on the container.

[0131] In another aspect, the fixing mechanism includes a collar that forms an interference fit with both the outer diameter of the container and the inner diameter of the adapter.

[0132] In another aspect, the fixing mechanism further includes a second part that is a sleeve that fits over the container, and the sleeve includes a flange that engages the collar such that when the container is removed from the adapter, the flange pulls the collar out of the adapter.

[0133] In another aspect, the fixing mechanism includes a collar that forms an interference fit on the container, and the fixing mechanism has a bearing within the fixing mechanism.

[0134] In another aspect, the fixing mechanism includes a ratchet collar, and the ratchet collar includes tabs that grip the container when the container is removed from the adapter.

[0135] In another aspect, the fixing mechanism is a one-way collar that fits over the container, and the one-way collar includes a tubular portion and a flange portion, and the tubular portion includes a grip on a surface that contacts the container.

[0136] In another aspect, the fixing mechanism includes a collar, a detent that engages the base of the adapter, and a flange that prevents the collar from advancing into the adapter.

[0137] In another aspect, the securing mechanism includes a collar, the collar including a one-way grip that extends upwardly into a collar that fits onto the container, whereby the container can be advanced through the collar in only one direction. The securing mechanism further includes a tape adhered to the container and the collar to secure the container in a first position, the tape being removed or torn when the container is advanced to a second position.

[0138] In another aspect, the securing mechanism includes a first collar portion and a second collar portion, each of the first and second collar portions forming an interference fit with the container. The first collar portion includes a receptacle for a return on the second collar portion, and the first and second collar portions are joined when the container is advanced to a second position such that the first and second collar portions are carried with the container when the container is removed from the adapter.

[0139] In another aspect, the securing mechanism includes a snap ring, the snap ring including a protrusion that extends upwardly into the adapter when the snap ring is received by the adapter. The container supports a sleeve thereon, the sleeve supporting an O-ring, the O-ring forming an interference fit between the container and the adapter when the O-ring is advanced into the adapter. The sleeve includes a protruding portion that is captured by the protrusion when the container is advanced into the adapter.

[0140] In another aspect, the securing mechanism includes a flanged sleeve, the sleeve being flexible and having a diametrical gap between the sleeve and the container.

[0141] In another aspect, the securing mechanism has a first portion of a two-piece collar that includes a clip, and a second portion that includes a collar that also provides an interference fit on the container. When the container is advanced to a second position, the clip advances over the second portion of the collar, and when the container is removed from the adapter, the clip pulls the second portion of the collar out of the adapter.

[0142] In another aspect, the fixing mechanism is a flanged sleeve that includes a detent that engages the base of the adapter, and the detent can be rotated to disengage from the engagement with the base of the adapter to remove the container and the fixing mechanism from the adapter.

[0143] In another aspect, the container is fixed in the first position by a removable adhesive tape.

[0144] In another aspect, the fixing mechanism is a threaded sleeve that forms an interference fit with the container and is advanced upward into the adapter by screwing the sleeve into the adapter, and the container is retracted from the adapter by loosening the screw of the sleeve.

[0145] In another aspect, the fixing mechanism includes a collar and a sleeve. The collar includes a guide notch that accommodates a protruding guide on the sleeve. The guide notch has a detent at the guide notch. The detent holds the protruding guide in a predetermined position when the container is in the first position. The sleeve further includes a tab that is biased outward so that the tab carries the collar away from the adapter when the container is removed from the adapter.

[0146] In another aspect, the fixing mechanism includes a collar and a sleeve. The collar includes a clip configured to be attached to the base of the adapter and a tapered inner portion that houses the sleeve. The sleeve has a first protruding portion that cooperates with a detent inside the sleeve to hold the container in the first position, and a second protruding portion that deflects the sleeve, thereby allowing the clip to separate from the base and the container to be removed from the adapter.

[0147] In another aspect, the securing mechanism is a collar having posts that cooperate with a first lateral slot and a second linear slot provided in the intersecting and adapter, the slots accommodating the posts such that rotating the container causes the posts on the collar to be received in the lateral slot, enabling the container to be locked in the first position, and when the container is rotated such that the posts are positioned in the linear slot, the container can be advanced to the second position or removed from the adapter.

[0148] In another aspect, the securing mechanism is a collar having posts that cooperate with a first inclined slot and a second linear slot provided in the intersecting and adapter, the inclined slot accommodating the posts to enable the container to be locked in the first position and to advance the container to the second position, the container being rotated such that the posts are positioned in the linear slot, which enables the container to be advanced to the second position or removed from the adapter.

[0149] In another aspect, the securing mechanism is a collar having posts that cooperate with a slotted track in the adapter, the slotted track engaging the posts at a first end that holds the posts such that the container is held in the first position in the adapter, rotating the container causes the posts to move to a portion of the track that enables the container to be advanced to the second position, rotating the container again causes the posts to advance to a portion of the track that enables the container to be removed from the adapter, and the container carries the collar out of the adapter.

[0150] In a further aspect, the portion of the slotted track that holds the container in the first position includes a detent for holding the posts in a predetermined position.

[0151] In another aspect, the fixing mechanism includes a collar and a sleeve assembly. The collar includes a first portion that is received within the adapter and a flange portion that does not advance into the adapter. The collar further includes a biased detent pin that includes a locking detent and a follower detent that locks within a slot provided in the adapter. The sleeve includes a slot having an angled portion and a longitudinal portion. The container is locked in a first position by the locking detent when the detent pin is aligned with the angled portion of the slot, and the container can be advanced to a second position or removed from the adapter when the detent pin is aligned with the longitudinal portion of the slot such that the locking detent is not retained within the adapter slot.

[0152] In another aspect, the fixing mechanism includes a collar and a sleeve assembly. The collar includes a flexible post, and the sleeve includes a flange that does not advance into the adapter. The adapter includes a deflectable tab arranged to be received within a slot in the sleeve to lock the container in a first position in the adapter. Advancing the collar into the container causes the flexible post to move the deflectable tab out of engagement with the slot in the sleeve, enabling the container to be advanced to a second position or out of the adapter.

[0153] In another aspect, the fixing mechanism includes a sleeve that includes a bump-off, a first slot, a second slot, and a flange that stops the sleeve from advancing completely into the adapter, and a collar that includes a protruding portion and a flexible protrusion and rib biased towards the interior of the adapter in which the container is received. The rib engages the container in which the sleeve is disposed, and the adapter includes a protrusion biased inwardly. The protrusion engages the sleeve slot to hold the container in a first position. The protruding portion of the collar moves the protrusion out of engagement with the sleeve slot, thereby enabling the container to advance to a second position, locking the collar to the sleeve, and enabling the sleeve and collar to be removed together with the container.

[0154] From the foregoing and with reference to the various drawings, those skilled in the art will recognize that they can make certain modifications to the present disclosure without departing from the scope of the present disclosure. Although multiple embodiments of the disclosure are shown in the drawings, the disclosure is not intended to be limited thereto, and the disclosure has as broad a scope as the technology permits and is intended to be read in conjunction with the specification. Accordingly, the above description should not be construed as limiting, but rather should be construed merely as an exemplification of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

1. A sample collection system, A container for collecting samples, An adapter comprising a distal end, a proximal end, a needle, and an interior, wherein the adapter is configured to receive a sample through a connector at the distal end, the needle extends from the connector into the interior of the adapter, and the proximal end includes an opening for accommodating the first end of the container into the interior of the adapter, A fixing mechanism configured to fix the container in a releasable manner in a first position, wherein in the first position, the first end of the container is held in a position that is spaced apart from the needle inside the adapter, comprising: The fixing mechanism is operated such that the container is advanced distally from the first position to the second position within the adapter, thereby enabling engagement with the needle to receive the sample into the container. The fixing mechanism is further configured to allow the container to be pulled out in a proximal direction in order to remove the container from the inside of the adapter, A sample collection system wherein the fixing mechanism is configured to be removed by the container when the container is removed from the inside of the adapter.

2. The sample collection system according to claim 1, wherein the fixing mechanism includes a collar fitted onto the container.

3. The sample collection system according to claim 2, wherein the collar has an inner diameter larger than the outer diameter of the container and an outer diameter smaller than the inner diameter of the adapter.

4. The sample collection system according to claim 2 or 3, wherein the collar provides a tight fit when advanced into the adapter.

5. The sample collection system according to any one of claims 2 to 4, wherein the collar has a flange that prevents the collar from being fully advanced into the adapter.

6. The sample collection system according to claim 1, wherein the fixing mechanism is a c-clamp.

7. The sample collection system according to claim 6, wherein the fixing mechanism further includes an elastic gasket housed on the container, forming a tight fit for the container in the adapter.

8. The sample collection system according to claim 1, wherein the container includes a cap, the cap includes a diaphragm and a shield, the shield extending from the diaphragm and surrounding a portion of the outer circumference of the container.

9. The sample collection system according to claim 8, wherein the fixing mechanism is a collar on the container that forms a snap fit with the base of the shield, and the fixing mechanism provides a tightening fit in the adapter when advanced into the adapter.

10. The sample collection system according to claim 9, wherein the collar has a flange at its proximal end to prevent the collar from advancing completely into the adapter.

11. The sample collection system according to claim 1, wherein the adapter has a spring inside the adapter, the spring provides resistance when the container is advanced into the adapter and engages with the needle, and the spring biases the container to advance out of the adapter after sample collection.

12. The sample collection system according to claim 1, wherein the fixing mechanism is a flanged foam rubber collar positioned on the container, which, when advanced into the adapter, tightens and fits with the adapter, and the flange has a diameter larger than the inner diameter of the adapter to prevent the flanged collar from being fully advanced into the adapter.

13. The sample collection system according to claim 1, wherein the fixing mechanism is a foamed rubber collar positioned on the container and fixed within a flanged opening at the proximal end of the adapter, the foamed rubber collar forming a tight fit with the container, but allowing the container to be advanced and pulled out through the collar.

14. The sample collection system according to claim 1, wherein the fixing mechanism is a foamed rubber collar fixed on the container and forms a tight fit when introduced into the adapter.

15. The sample collection system according to claim 14, wherein the foamed rubber collar is fixed onto the container by adhesive.

16. The sample collection system according to claim 1, wherein the fixing mechanism is a flanged O-ring collar on the container, the O-ring forms a friction fit in the adapter when the container is advanced in the adapter, the flange does not advance into the adapter, and the container is movably housed in the flange.

17. The sample collection system according to claim 8, wherein the shield has a first O-ring at its proximal end and a second O-ring at its distal end, and each O-ring provides a tight fit when it is inside the adapter.

18. A sample collection system, A container for collecting samples, An adapter comprising a distal end, a proximal end, a needle, and an interior, wherein the adapter is configured to receive a sample through a connector at the distal end, the needle extends from the connector into the interior of the adapter, and the proximal end includes an opening for accommodating the first end of the container into the interior of the adapter, A fixing mechanism configured to hold the container in a first position, wherein in the first position, the first end of the container is held in a position that is spaced apart from the needle inside the adapter, comprising: The fixing mechanism is configured such that the container is advanced distally from the first position to the second position within the adapter, thereby enabling engagement with the needle to receive the sample into the container. The fixing mechanism is further configured to allow the container to be pulled out in a proximal direction in order to remove the container from the inside of the adapter, A sample collection system wherein, when the container is removed from the inside of the adapter, the fixing mechanism is configured to be pulled out by the container.

19. The sample collection system according to claim 18, wherein the fixing mechanism is formed of rubber and has an annular shape, the fixing mechanism is arranged around the outside of the container, and the fixing mechanism has a distal portion including a thickness that fits between the container and the adapter, and a proximal portion including a flange having a diameter exceeding the inner diameter of the adapter.

20. The sample collection system according to claim 18, wherein the fixing mechanism provides a snap fit with a shield for the container, and the fixing mechanism includes a rim that extends away from the container and provides a stop to prevent the fixing mechanism from being advanced further into the adapter.

21. The sample collection system according to claim 18, wherein the fixing mechanism includes a compressible spring attached to the distal end of the container, the compressible spring being configured to be inserted between the container and the adapter, the compressible spring holding the container in the first position, but allowing the container to be advanced to the second position when the tension provided by the spring is overcome.

22. The sample collection system according to claim 18, wherein the fixing mechanism includes a foamed rubber flange that provides a tight fit in the container, and the container can be advanced from a first position to a second position by applying force to the foamed rubber flange, the first portion of the foamed rubber flange can be advanced into the adapter, but the second portion of the foamed rubber flange is too large to be advanced into the adapter.

23. The sample collection system according to claim 18, wherein the fixing mechanism is a foamed rubber flange fixed by adhesive to the corresponding flange at the base of the adapter.

24. The sample collection system according to claim 18, wherein the fixing mechanism is a collar, and the collar cannot be advanced into the adapter, but the collar forms a friction fit with the container so that the container can be advanced through the collar from a first position to a second position.

25. The sample collection system according to claim 18, wherein the fixing mechanism is an O-ring fixed on the container by a flange formed on the container.