Sample collection system

Abstract

A sample collection system is provided. In one aspect, a sample collection system includes a container, an adapter, and a fixture. The adapter receives the first end of the container into an interior of the adapter. The fixture holds the container in a first position in which the first end of the container is thereby held in a spaced relationship with the needle of the adapter. The fixture is operated or operated to allow the container to be advanced distally within the interior of the adapter from the first position to a second position to engage the needle to receive a sample in the container. The fixture also allows the container to be proximally withdrawn to remove the container from the interior of the adapter, where the securing mechanism is removed by the container when the container is removed from the interior of the adapter.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 359,373, filed on July 8, 2022, which is incorporated herein by reference. Technical Field

[0003] The present technology relates to a sample collection system having an adapter and a disposable sample collection container into which an initial portion of a patient sample is collected. The adapter is fluidly coupled to a patient's vein using venipuncture. Initially, the patient sample is drawn through the adapter and enters the disposable collection system. Once the initial portion of the sample is collected, the disposable sample collection container and the mechanism that holds the disposable sample collection container in the adapter are discarded and the adapter is fluidly coupled to a sample collection vessel for collecting the remainder of the patient sample. Background Art

[0004] Blood culture testing is currently the preferred method for identifying bacteremia and sepsis (sepsis). Sepsis is a systemic response to a bloodstream bacterial infection that can lead to organ failure and death. One in six infected patients dies from sepsis. In addition, half of all hospital deaths involve sepsis. In fact, sepsis kills more people than AIDS, breast cancer, and prostate cancer combined. Sepsis affects more hospital patients than any other diagnosis. Given the prevalence of sepsis, patients' blood is frequently monitored to determine if bacteria indicative of the onset of sepsis are present in the patient's blood.

[0005] Clearly, there is a need to accurately and reliably determine whether a patient has sepsis. Unfortunately, the U.S. healthcare system spends more than $4 billion per year on unnecessary treatment associated with false-positive blood culture results. See Oren Zwang & Richard K. Albert, Analysis of Strategies to Improve Cost Effectiveness of Blood Cultures, 1 J. Hosp. Med. 272 ​​(Sep. 2006). In addition, "[i]t is currently accepted that most organisms identified as contaminants in blood cultures originate from the skin of the patient." Robert A. Garcia et al., Multidisciplinary Team Review of Best Practices 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).

[0006] Therefore, during the blood collection process, a device is needed that can capture the initial blood flow from the patient, which may contain contaminants from the patient's skin, to prevent part of the collected sample from entering the blood culture. Capturing the initial portion of the collected blood can reduce the number of positive collections. One such device is described in WO2019018324 to Milan Ivosevic, filed on July 17, 2018 as PCT / US2018 / 042367 and incorporated herein by reference in its entirety. Another such device is described in U.S. Provisional Application No. 62 / 883941, filed on August 7, 2019 and incorporated herein by reference in its entirety. Summary of the invention

[0007] A sample collection system is described herein. The system includes: a container for collecting a sample; an adapter having a distal end, a proximal end, a needle, and an interior. The adapter is configured to receive a sample through a connector at the distal end. The sample can be collected via venous puncture or via an intravenous catheter. The needle extends from the connector to the interior of the adapter, and the proximal end includes an opening to receive the first end of the container into the interior of the adapter. The system also includes a fixing mechanism configured to releasably fix the container at a first position, wherein, at the first position, the first end of the container is maintained in a spaced relationship with the needle in the interior of the adapter. On the one hand, the fixing mechanism is operated to allow the container to be advanced distally from the first position to a second position within the interior of the adapter, thereby engaging the needle to receive the sample into the container. On the one hand, the fixing mechanism is further configured to enable the container to be withdrawn proximally to remove the container from the interior of the adapter. On the other hand, when the container is removed from the interior of the adapter, the fixing mechanism is configured to be removed by the container.

[0008] In one aspect, the securing mechanism comprises a collar that fits over the container. In another aspect, the collar has an inner diameter that is greater than the outer diameter of the container and an outer diameter that is less than the inner diameter of the adapter. In another aspect, the collar provides an interference fit when advanced into the adapter. In yet another aspect, the collar has a flange that prevents the collar from being fully advanced into the adapter.

[0009] In another aspect, the securing mechanism is a c-clamp. The securing mechanism may also have a resilient washer received on the container and forming an interference fit to the container within the adapter.

[0010] In another aspect, the container has a cap, which may have a septum and a shield. The shield may extend from the septum and surround a portion of the periphery of the container. In another aspect, the shield may have a first O-ring at a proximal end and a second O-ring at a distal end, each O-ring providing an interference fit when in the adapter.

[0011] In another aspect, the securing mechanism is a collar on the container that forms a snap fit with the base of the shield, and when advanced into the adapter, the securing mechanism provides an interference fit in the adapter. In yet another aspect, the collar has a flange at its proximal end to prevent the collar from being fully advanced into the adapter.

[0012] In another aspect, the adapter may have a spring on its interior that provides resistance as the container is advanced into the adapter and engages the needle, the spring being biased to push the container out of the adapter after sample collection.

[0013] In another aspect of the sample collection system, the securing mechanism is a flanged foam rubber ring placed on the container which forms an interference fit with the adapter when pushed into the adapter, the flange having a diameter greater than an inner diameter of the adapter to prevent the flanged ring from being fully pushed into the adapter.

[0014] In another aspect of the sample collection system, the securing mechanism is a foam rubber collar placed on the container that seats within a flanged opening at the proximal end of the adapter, the foam rubber collar forming an interference fit with the container but allowing the container to be advanced and withdrawn through the collar.

[0015] In another aspect of the sample collection system, the securing mechanism is a foam rubber collar secured to the container that forms an interference fit when introduced into the adapter. In yet another aspect, the foam rubber collar is secured to the container with an adhesive.

[0016] In another aspect of the sample collection system, the securing mechanism can be a flanged O-ring on the container, wherein the O-ring forms a friction fit in the adapter when the container is advanced in the adapter, and wherein the flange is not advanced into the adapter. In this aspect, the container is removably received in the flanged portion. In another aspect, a sticker is provided to secure the container in its shipping position.

[0017] In another aspect, an alternative mechanism is provided that provides a friction fit for a flange / O-ring assembly that separates the container (i.e., the disposal tube) from the adapter needle during shipping. In this aspect, the O-ring is positioned below the cap on the container and has a friction fit within the adapter such that the container is slidably engaged in the adapter. A securement is provided to secure the container in its shipping position. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a side cross-sectional view of a sample collection system according to the present technology.

[0019] Figure 2A is a side cross-sectional view of another sample collection system according to the present technology.

[0020] Figure 2B yes Figure 2A Side perspective view of the system's C-clip.

[0021] Figure 3A is a side cross-sectional view of another sample collection system according to the present technology.

[0022] Figure 3B yes Figure 3A A close-up of the system's securing mechanism.

[0023] Figure 4 is a side cross-sectional view of another sample collection system according to the present technology.

[0024] Figure 5A-5D Another aspect of the assembly is to maintain the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. As shown, a side view of the sample collection system shows a foam rubber flange that provides the desired separation during shipping and storage and remains attached to the disposal tube when removed from the adapter.

[0025] Figure 6 Another aspect of the assembly is to maintain the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. As shown, a side view of the sample / collection discharge tube has a foam rubber flange that is friction fit on the discard tube, which is pulled away from the adapter when the tube is removed from the adapter. A tab defines the spaced relationship between the discard tube and the cap thereon.

[0026] Figure 7 Another aspect of the assembly is to maintain the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. Figure 7 Shown in FIG. 1 is an alternative foam flange that friction fits with the tube.

[0027] Fig. 8A An alternative mechanism to provide a friction fit to the flange / O-ring assembly that separates the discard tube from the adapter needle during shipping. In this aspect, the O-ring is positioned below the cap and has a friction fit within the adapter so that the discard tube is slidably engaged in the adapter. A retainer is provided to secure the discard tube in its shipping position.

[0028] Figure 8B The invention is an improved cap or stopper with an O-ring disposed in a groove for slidable engagement of the cap in the adapter. The O-ring provides a friction fit in the adapter.

[0029] Figure 8C A sample collection system is shown having Figure 8B A cap in the adapter and a fastener located at the flange of the adapter base, the fastener secures the collection / disposal tube in a spaced relationship with the adapter needle.

[0030] Figure 9A-9I The operation of the sample collection / disposal tube in the adapter is shown. The sample collection / disposal tube has a sleeve fitted thereon with a flange to receive an O-ring, which secures the sample collection / disposal tube from engaging the needle in the adapter during shipping, but allows the collection / disposal tube to be slid into engagement with the needle for sample collection and then removed from the adapter after sample collection.

[0031] Figure 10A-10B Another aspect of the assembly is to maintain the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. Figure 10A-10B Specifically shown is a rubber ring that fits over the bottom of the adapter and snugly receives the collection tube to ensure it remains spaced apart from the needle in the adapter during shipping. The collection / disposal tube can be advanced into engagement with the needle for sample collection. After sample collection, the rubber ring is pulled out of engagement with the adapter along with the collection / disposal tube.

[0032] Fig.11 Figure 10- Fig. 10B The rubber ring fits in the adapter and the sample collection / disposal tube has a flanged ring that engages the rubber ring in the adapter. When the collection / disposal tube is removed from the adapter, the rubber ring is pulled from the adapter ring by the flanged ring.

[0033] Fig.12 is another alternative structure of a rubber ring disposed at the bottom of the adapter. In this aspect, the rubber ring has a bearing that allows the collection / disposal tube to be advanced into engagement with the needle in the adapter. The flange prevents the rubber ring from being advanced into the adapter. When the collection / disposal tube cap is pushed out of the adapter, the rubber ring is removed from the adapter.

[0034] Figure 13A-13B Another aspect of the assembly is to maintain the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. Figure 13A-13B A collar is shown with tabs that provide an interference fit in the adapter. Fig. 13B As shown, when the tube is advanced into engagement with the adapter needle, the collar remains in place. When the collection / disposal tube is pulled from the adapter, the collar is removed from the adapter.

[0035] Figure 14A-Figure 14D is another aspect of the assembly that maintains the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. Figure 14A-Figure 1 4D shows a one-way collar with an inner grip that provides friction that allows the collection / disposal tube to be pushed into the adapter. As shown in FIG. 14D , the collar grips the tube so that when the collection / disposal tube is pulled from the adapter, the collar is removed from engagement with the adapter. The collar has a catch that receives a flange at the base of the adapter. The catch is made of a soft material (TPE) so that the seal to the adapter can be broken and separated from the adapter.

[0036] Figures 15A-15D Show Figure 14A-Figure 1 An alternative to the collar of the 4D. The one-way collar in this aspect has ratchets that engage the base of the adapter. The collar cannot be pushed upward into the adapter. The collar grips the collection / disposal tube so that when the ratchet mechanism is placed in the correct orientation to allow the collection / disposal tube to be pulled from the adapter, the collar disengages from engagement with the adapter. The grip is directed upward to further secure the collar on the collection / disposal tube.

[0037] Figures 16A-16D Show Figures 15A-15D An alternative to the collar of a collection / disposal tube in which a fastener is added to secure the collar to the collection / disposal tube.

[0038] Figure 16E-16K Show Figures 16A-16D The upward facing grip makes it possible to push the collection / disposal tube up into the adapter, but when the collection / disposal tube is pushed out of the adapter, it carries the collar away from the adapter.

[0039] Figure 17A-17B yes Figure 13A-13B Two-piece alternative to the collar shown. The barbed collar is attached to the collection / disposal tube by an interference fit. When pushed into the adapter, the barbs lock into the holes of the adapter collar. When the collection / disposal tube is pushed out of the adapter, it takes the two-piece assembled collar away from the adapter.

[0040] Figures 18A-18CAnother two-piece assembly for holding a collection / disposal tube in a spaced arrangement with a needle in an adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. When the collection / disposal tube is removed from the adapter, the two-piece assembly is pulled therefrom. A snap ring with an upwardly facing extension fits into the base of the adapter. A sleeve with first and second flanges fits over the collection / disposal tube. When the first flange is advanced over the snap ring, the collection tube is held in place for shipping. When the second flange passes through the snap ring, the collection tube engages with the needle for sample collection. When the collection / disposal tube is removed from the adapter, the second flange on the sleeve pulls the snap ring from the adapter.

[0041] Figure 19A-Figure 19C yes Figures 18A-18C An alternative aspect of a two-piece assembly for holding a collection / disposal tube in a spaced arrangement with a needle in an adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. When the collection / disposal tube is removed from the adapter, the two-piece assembly is pulled from the adapter. A snap ring with an upwardly facing extension fits into the base of the adapter. In this aspect, the sleeve has a first, second, and third flanges on the sleeve that fits over the collection / disposal tube. When the first flange is advanced over the snap ring, the collection tube is held in place for shipping. When advanced within the snap ring, the second flange pushes the snap ring outward, holding the collection / disposal tube in place for shipping. When the third flange passes the snap ring, the collection tube engages with the needle for sample collection. When the collection / disposal tube is removed from the adapter, the third flange on the sleeve pulls the snap ring out of it.

[0042] Fig. 20 A collection / discard tube having a flanged sleeve thereon that is used to hold the collection / discard tube in a spaced arrangement with the needle in the adapter during shipping but allows the collection / discard tube to be advanced into engagement with the needle for sample collection. When the collection / discard tube is placed in the adapter, the flanged sleeve prevents the sleeve from being advanced beyond the open end of the adapter. The flanged sleeve is flexible. When the collection / discard tube is advanced through the sleeve and into engagement with the needle in the adapter for blood collection, the sleeve remains in place. Because the sleeve is flexible, it can assist in holding the collection / discard tube when it is removed from the adapter.

[0043] Fig.21The invention is a two-part collar in which the collar fits into the base of the adapter but is not pushed into it. The first part of the collar in the base of the adapter cooperates with the collar on the collection / disposal tube to hold the collection / disposal tube in a spaced relationship with the needle in the adapter. The second part of the collar on the collection / disposal tube has an arm with a notched engagement member that will be pushed through the first part of the collar when the collection / disposal tube is pushed into the adapter. Thus, the second part of the collar is made into an outside clamp. When the collection / disposal tube is removed from the adapter after sample collection, the engagement member on the second part of the collar pulls the first part of the collar from the base of the adapter.

[0044] Fig. 22 is another flanged sleeve for a collection / disposal tube. The flange locks to a flange at the bottom of the adapter, with the lip fitting over the adapter base flange. The collection / disposal tube is held in a spaced arrangement with the needle in the adapter by the sleeve during shipment. Advancing the collection / disposal tube through the sleeve advances the collection / disposal tube into connection with the adapter needle. After sample collection, the sleeve's flexible flange fasteners detach from the flange at the base of the adapter, and the collection / disposal tube with the sleeve attached is removed from the adapter.

[0045] Figure 23A-23C Another flanged sleeve is separated by squeezing the elastomeric sleeve to separate the sleeve flange from the flange at the base of the adapter when the collection / disposal tube is removed from the adapter. In one aspect, the sleeve is attached to the collection / disposal tube during shipping by a shrink wrap or band that ensures that the collection / disposal tube remains spaced apart from the needle during shipping.

[0046] Figure 24A-24B yes Figure 23A-23C One aspect of what is shown shows how the sleeve flange seats on a flange at the base of the adapter to keep the collection / disposal tube and adapter needle in a spaced position during shipping.

[0047] Figure 25A-25B yes Figure 23A-23C One aspect of what is shown shows how a sleeve can be attached to a collection / disposal tube to ensure that the discard collection tube is maintained in a spaced arrangement with the adapter flange needle during shipping.

[0048] Fig.26A collar for a collection / disposal tube is shown, the collar having a foldable section with a living hinge, the living hinge allows the collar to hold the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping, but for blood collection, when the collection / disposal tube is advanced toward the needle, the living hinge folds, allowing the collection / disposal tube to be advanced into contact with the adapter needle for blood collection. After collection, when the collection / disposal tube is removed from the adapter, the collar is removed with the collection / disposal tube.

[0049] Figure 27A-27B Another aspect of the collection / disposal tube assembly is wherein the collection / disposal tube has a sleeve attached thereto, the sleeve having 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 blood is drawn into the collection / disposal tube when a needle in the adapter pierces a seal in the cap of the collection / disposal tube when the collection / disposal tube is advanced into contact with the needle. The collection / disposal tube is advanced in the sleeve, and the sleeve remains fixed when locked onto the flange of the adapter. When the sleeve is twisted off the flange of the adapter, the collection / disposal tube is removed from the adapter.

[0050] Fig.28 It is another aspect of the assembly of the collection / discarding tube for keeping the collection / discarding tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / discarding tube to be advanced into engagement with the needle for sample collection. In this aspect, the collection / discarding tube has a sleeve that can be threaded into the adapter. There is a flange at the base of the sleeve, as shown in the figure, the flange has a spiral ridge, and the spiral ridge provides a friction fit when it is advanced into the adapter. The flange limits the distance that the sleeve can be advanced. During shipping and storage, the sleeve keeps the collection / discarding tube in a spaced relationship with the needle. The collection / discarding tube is twisted to advance it in the sleeve. As shown in the figure, the pipeline set is in fluid communication with the adapter, and when the needle in the adapter pierces the seal in the cap of the collection / discarding tube when the collection / discarding tube is advanced into contact with the needle, blood is drawn into the collection / discarding tube. After sample collection, the collection / discarding tube is removed from the adapter.

[0051] Figures 29A-29CAnother aspect of a collection / disposal tube assembly is shown for maintaining a collection / disposal tube in a spaced relationship with a needle in an adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. The collection / disposal tube has a hinged spring ring that locks the collection / disposal tube in a spaced relationship with the needle during shipping and storage. When the collection / disposal tube is advanced in the adapter, the spring flattens into the ring. When the needle in the adapter pierces the seal in the cap of the collection / disposal tube when the collection / disposal tube is advanced into contact with the needle, blood is drawn into the collection / disposal tube. After sample collection, the collection / disposal tube is removed from the adapter along with the hinged spring.

[0052] Figure 30A-Figure 30C Another aspect of a two-piece collar / sleeve assembly, wherein the collar has a notch, is used to maintain a collection / disposal tube in a spaced relationship with a needle in an adapter during shipping and storage, but to allow the collection / disposal tube to be advanced into engagement with the needle for sample collection. The sleeve has a raised guide that travels through the notch in the adapter collar. The sleeve fits over the collection / disposal tube. The sleeve has ratchets that maintain the collection / disposal tube in a spaced relationship with the needle during shipping and storage. Blood is drawn into the collection / disposal tube when the needle in the adapter pierces the seal in the cap of the collection / disposal tube as the collection / disposal tube is advanced into contact with the needle by bypassing the ratchets. After sample collection, the collection / disposal tube is removed from the adapter along with the collar and sleeve, and the sleeve forces the collar away from the adapter when the collection / disposal tube is removed from the adapter.

[0053] Figure 31A-Figure 31B yes Figure 30A-Figure 30C A modified aspect of the content shown in . The two-piece collar / sleeve assembly in this aspect also has a collar with a notch. The collar has a clamp that is fastened to a flange at the base of the adapter. The sleeve has a raised guide that travels through the notch in the adapter collar. The sleeve fits on the collection / disposal tube. The sleeve has a raised portion at the base of the sleeve that prevents the sleeve from being pushed too far into the adapter collar and ensures that the collection / disposal tube remains in a spaced relationship with the needle during shipping and storage. When the needle in the adapter pierces the seal in the cap of the collection / disposal tube when the collection / disposal tube is pushed into contact with the needle due to bypassing the ratchet, blood is drawn into the collection / disposal tube. After the sample is collected, the collection / disposal tube is removed from the adapter together with the collar and sleeve, and the sleeve forces the collar to leave the adapter when the collection / disposal tube is removed from the adapter.

[0054] Figure 32A-32BA modified aspect of an assembly for maintaining a collection / discarding tube in a spaced arrangement with a needle in an adapter during shipping but allowing the collection / discarding tube to be advanced into engagement with the needle for sample collection. In this aspect, a collar disposed / fixed on the collection / discarding tube has a post that engages a slot in the adapter housing. The side slots allow the collar to be rotated into a locked position that locks the collection / discarding tube into a spaced relationship with the needle during shipping and storage. To advance the collection / discarding tube into engagement with the adapter needle, the collection / discarding tube is rotated and the collar / collection / discarding tube assembly can be advanced into engagement with the needle in the adapter for blood collection because the collar pin can be advanced again along the slot in the adapter housing. After sample collection, the collection / discarding tube is removed from the adapter together with the collar.

[0055] Figure 33A-Figure 33B yes Figure 32A-32B A modification of the aspect of the invention. A collar disposed on the collection / discarding tube has a post that engages a slot in the adapter housing. The side slots allow the collar to be rotated into a locked position that locks the collection / discarding tube in a spaced relationship with the needle during shipping and storage. The side slots are angled downward so that the collection / discarding tube is pulled slightly out of the adapter as the pin is advanced in the ratchet slot. To advance the collection / discarding tube into engagement with the adapter needle, the collection / discarding tube is rotated and the collar / collection / discarding tube assembly can be advanced into engagement with the needle in the adapter for blood collection as the collar pin can be advanced again along the slot in the adapter housing. After sample collection, the collection / discarding tube is removed from the adapter along with the collar.

[0056] Figure 34A-Figure 34B yes Figure 32A-32B A modification of the aspect of the invention. A collar disposed on the collection / discarding tube has a post that engages a slot in the adapter housing. The side slots allow the collar to be rotated into a locked position that locks the collection / discarding tube in a spaced relationship with the needle during shipping and storage. To advance the collection / discarding tube into engagement with the adapter needle, the collection / discarding tube is rotated and the collar / collection / discarding tube assembly can be advanced into engagement with the needle in the adapter for blood collection because the collar pin can be advanced again along a slot adjacent to the side slot in the adapter housing. After sample collection, the collection / discarding tube is rotated again and the collar pin travels down the discarding slot, thereby removing the collection / discarding tube from the adapter together with the collar.

[0057] Figure 35A-Figure 35B yes Figure 32A-32BIn one aspect, the adapter has a collar with a ratchet pin and the collection / discarding tube has a slot that engages the ratchet post and controls the movement of the collection / discarding tube relative to the adapter. The ribbed sleeve fits snugly over the collection / discarding tube. When the collection / discarding tube is rotated so that the ratchet post is engaged in the side slot, this locks the collection / discarding tube into a spaced relationship with the needle during shipping and storage. To advance the collection / discarding tube into engagement with the adapter needle, the collection / discarding tube is rotated and the collar / collection / discarding tube assembly can be advanced into engagement with the needle in the adapter for blood collection because the collar pin can be advanced again along the slot in the sleeve. After sample collection, the collection / discarding tube is rotated again and the sleeve moves downward because the collar pin is aligned with the slot in the sleeve. When the collection / discarding tube is removed from the adapter, it engages with the adapter collar, thereby pulling it from the adapter.

[0058] Figure 36A-36B Another aspect of the assembly is to maintain the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and to allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In the illustrated aspect, the adapter has a sleeve that locks into an opening in the adapter housing. The collection / discarding tube has a collar with a flexible extension that aligns with a groove in the adapter sleeve. When the latch in the sleeve is depressed, the collection / discarding tube can be advanced into engagement with the needle in the adapter. At this point, the flexible extension engages the opening in the sleeve, causing the collar and sleeve to engage. After sample collection, the collection / discarding tube is removed from the adapter together with the adapter sleeve.

[0059] Figure 37A-Figure 37B Another aspect of the assembly is to maintain the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and to allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In the illustrated aspect, the adapter has a sleeve with a bump off that receives a latch on a collar that is press-fit onto the collection / discarding tube. When the latch in the collar is depressed, the collection / discarding tube can be advanced into engagement with the needle in the adapter. The collar also has an extension that travels along a guide in the adapter sleeve. At this point, the latch on the collar engages the sleeve. After sample collection, the collection / discarding tube is removed from the adapter together with the adapter sleeve engaged with the collar.

[0060] Fig.38 yes Figure 37A-Figure 37B but uses a strap rather than relying on a stop to lock the collection / disposal tube into place during shipping and storage.

[0061] Figure 39A-Figure 39BAnother aspect of the assembly is to maintain the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and to allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. In the illustrated aspect, the adapter has a sleeve with a resilient stop that will allow a protrusion on a collar that is press-fit onto the collection / disposal tube to pass through it when force is applied to advance the collection / disposal tube in the adapter. Thus, the application of the band is to ensure that the collection / disposal tube maintains the desired spaced relationship with the adapter needle. When the band is removed, the collection / disposal tube can be advanced into engagement with the needle in the adapter. The collar also has a protrusion that travels along a guide in the adapter sleeve. At this point, the protrusion on the collar and the resilient stop engage the protrusion on the collar. After sample collection, the collection / disposal tube is removed from the adapter together with the adapter sleeve engaged with the collar.

[0062] Figure 40A-40B Another aspect of the assembly is to maintain the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. In the illustrated aspect, the adapter has a sliding groove and a locking groove that cooperate with a flexible finger-like member on a collar attached to the collection / disposal tube. Initially, the flexible finger-like member is disposed in the locking groove to ensure that the collection / disposal tube is maintained in the desired spaced relationship with the adapter needle during shipping and storage. The collection / disposal tube is rotated to place the finger-like member in the sliding groove of the adapter, and the collection / disposal tube can be advanced into engagement with the needle in the adapter. After sample collection, the collection / disposal tube is removed from the adapter by sliding it out along the sliding groove.

[0063] Fig.41 Another aspect of the assembly is to maintain a collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and to allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. In the illustrated aspect, the collection / disposal tube has a sleeve attached thereto, wherein a portion of the sleeve has an enlarged diameter. The adapter has a window that maintains an O-ring in an oval configuration. The oval O-ring maintains the collection / disposal tube in a spaced relationship with the adapter needle. When the collection / disposal tube is forced past the O-ring, the tube can be advanced into contact with the adapter needle for sample collection. In this position, the wider portion of the sleeve changes the O-ring configuration to a circular shape, thereby allowing the collection / disposal container to be withdrawn from the adapter, taking the O-ring with it.

[0064] Figure 42A-42BAnother aspect of the assembly is to maintain a collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and to allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. In the illustrated aspect, the collection / disposal tube has a sleeve attached thereto, wherein a portion of the sleeve has an enlarged diameter. The adapter has a window above a flange at its base that holds an oval ring. The oval ring holds the collection / disposal tube in a spaced relationship with the needle adapter. When the collection / disposal tube is forced past the oval ring, the tube can be advanced into contact with the adapter needle for sample collection. In this position, the wider portion of the sleeve changes the oval ring configuration to a circular shape, thereby allowing the collection / disposal container to be withdrawn from the adapter, taking the oval ring with it.

[0065] Figure 43A-43B Another aspect of the assembly is to maintain the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and to allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In the illustrated aspect, the adapter has a threaded inner collar with a flange that abuts a flange at the base of the adapter. The collection / discarding tube has a ring with a post. When the collection / discarding tube is placed in the adapter, the collection / discarding tube is held away from the adapter needle. When sample collection is required, the collection / discarding tube is rotated, which advances the ring, threading it so that the ring post falls into the ratchet teeth in the threaded inner collar. When engaged, the sample is collected. After the sample is collected, the sample collection / discarding tube ring is pulled out of the adapter together with the threaded inner collar.

[0066] Figures 44A-44B yes Figure 43A-43B An alternative aspect of the invention is another aspect of an assembly that maintains a collection / discarding tube in a spaced relationship with an adapter needle during shipping and storage and will allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In the illustrated aspect, the adapter has a flanged, slotted inner collar that abuts a flange at the base of the adapter. The slot has two ratchets. The collection / discarding tube has a ring with a post. When the collection / discarding tube is placed in the adapter, the collection / discarding tube is held away from the adapter needle by engagement of the post with the first ratchet. When sample collection is required, the collection / discarding tube is advanced so that the ring post falls into the locking ratchet at the top of the adapter sleeve. When engaged, the sample is collected into the collection / discarding tube. After sample collection, the sample collection / discarding tube ring is pulled out of the adapter together with the slotted inner collar.

[0067] Figure 45A-Figure 45BAnother aspect of the assembly is to maintain the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. The adapter has two retaining holes in its housing, near a flange at the bottom of the adapter. The collection / disposal tube has a sleeve having a first larger diameter, a second smaller diameter, and a flange distal to the cap of the collection / disposal tube. Disposed in the sleeve are fingers that extend outwardly and when aligned with the retaining holes in the adapter housing, the fingers will fit into the retaining holes in the adapter housing and hold the collection / disposal tube away from the needle in the adapter for storage and processing. Retracting the collar will release the fingers from the holes in the adapter housing. The collection / disposal tube is then advanced upward for sample collection. After sample collection, the sample collection / disposal tube is pulled from the adapter together with the sleeve and the fingers attached thereto.

[0068] Figure 46A-46B The invention relates to another aspect of the assembly that maintains the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. The adapter has two retaining holes in its housing, near the flange at the bottom of the adapter. The collection / discarding tube has a flanged collar and a holster with fingers thereon, the fingers extending upward and outward from the holster into the adapter. As the collar and collection / discarding tube are advanced into the adapter, the holes in the collar align with the holes in the adapter and the fingers extending from the holster on the collection / discarding tube lock the collection / discarding tube in a position away from the needle in the adapter for storage and processing. Retracting the collar releases the fingers from the holes in the adapter housing. The collection / discarding tube is then advanced upward for sample collection. After sample collection, the sample collection / discarding tube is pulled from the adapter together with the holster and the fingers attached thereto.

[0069] Figure 47A-47B A diversion adapter is shown that provides a first flow path for collecting a first portion of a collected sample and a second flow path for collecting a portion of the sample to be tested. The adapter has an inner sleeve that is retracted into the adapter when shipped. The inner sleeve is pulled back and the post in the inner sleeve locks into a ratchet in the adapter housing, and the diversion portion of the sample is drawn through the first flow path in the adapter into the upper chamber of the adapter. After the diversion sample is collected, the inner sleeve is pushed upward and the adapter engages a sample collection bottle, and the sample travels through the second flow path into the sample collection bottle.

[0070] Figure 48A-Figure 48BAnother aspect of an assembly is shown that maintains a collection / discard tube in a spaced relationship with an adapter needle during shipping and storage and will allow the collection / discard tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, the collection / discard tube is delivered into the adapter within a sleeve having a flange on the end of the sleeve away from the adapter needle. In a first position, when the collection / discard tube is held away from the adapter needle for shipping and storage, the band secures the sleeve in a position where the sleeve flange is spaced from the adapter flange at the adapter opening. When the retainer is peeled off, the collection / discard tube and sleeve are further advanced into the adapter for sample collection. After sample collection, the sample collection / discard tube is pulled from the adapter together with the sleeve.

[0071] Figure 49A-49F Different retainer configurations and placements are shown that maintain the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and that, after removal of the retainer, will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection.

[0072] Fig.50 Different fixture configurations and placements are shown that maintain the collection / discard tube in a spaced relationship with the adapter needle during shipping and storage and that will allow the collection / discard tube to be advanced into engagement with the needle in the adapter for sample collection after the fixture is removed. In this aspect, the collection / discard tube has a collar on it and the fixture maintains the collar and adapter separated. With the fixture severed, the collar can be advanced into the adapter for sample collection. After sample collection, the collection / discard tube is removed from the adapter along with the sleeve.

[0073] Fig.51 Shown is the use of heat shrink material that maintains the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and that will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection after the heat shrink material is removed. To advance the collection / disposal tube into the adapter, the heat shrink material is removed. After collection, the collection / disposal tube is removed from the adapter.

[0074] Fig.52 Another aspect of an assembly is shown that maintains a collection / discard tube in a spaced relationship with an adapter needle during shipping and storage and will allow the collection / discard tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, the collection / discard tube is delivered into the adapter within a sleeve having a bellows at its end. The bellows operate to maintain the collection / discard tube spaced from the adapter needle during shipping and storage. When sample collection is initiated, the collection / discard tube is forced upward, thereby crimping the bellows and allowing the adapter needle to be inserted into the collection / discard tube for sample collection. When the desired amount of sample is collected, the collection / discard tube and sleeve are removed from the adapter.

[0075] Fig.53 Another aspect of an assembly is shown that maintains a collection / discard tube in a spaced relationship with an adapter needle during shipping and storage and will allow the collection / discard tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, the collection / discard tube is delivered into the adapter in a sleeve having a crimped, corrugated portion. The crimped, corrugated portion operates to maintain the collection / discard tube spaced from the adapter needle during shipping and storage. When sample collection begins, the corrugated portion expands and the collection / discard tube is forced upward, allowing the adapter needle to be inserted into the collection / discard tube for sample collection. When the desired amount of sample is collected, the collection / discard tube and sleeve are removed from the adapter.

[0076] Fig.54 yes Fig.52 Another aspect of the components described in . Fig.54 Another aspect of an assembly is shown that maintains a collection / discard tube in a spaced relationship with an adapter needle during shipping and storage and will allow the collection / discard tube to be advanced into engagement with a needle in an adapter for sample collection. In this aspect, the collection / discard tube is disposed in a sleeve having a bellows at its distal end adjacent to a flange that does not allow the bellows to enter the adapter. The bellows operate to maintain the collection / discard tube spaced from the adapter needle during shipping and storage. When sample collection is initiated, the collection / discard tube is forced upward, thereby causing the bellows to collapse and allowing the adapter needle to be inserted into the collection / discard tube for sample collection. When the desired amount of sample is collected, the collection / discard tube is removed from the adapter. The sleeve, which has never entered the adapter, remains on the collection / discard tube.

[0077] Figure 55A-Figure 55B Another aspect of the assembly is to maintain the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and to allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, the collection / discarding tube is placed in a sleeve with a netting disposed on the exterior of the collection / discarding tube. The folding operation in the netting is to keep the collection / discarding tube separated from the adapter needle during shipping and storage. When sample collection begins, the collection / discarding tube is forced upward, allowing the folding to unfold, thereby allowing the collection / discarding tube to engage the adapter needle, whereby the needle is inserted into the collection / discarding tube for sample collection. When the desired amount of sample is collected, the collection / discarding tube is removed from the adapter together with the netting.

[0078] FIG. 56 is another aspect of an assembly that maintains the collection / discard tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discard tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, a stopper is positioned on top of the cap of the collection / discard tube. When the stopper / collection / discard tube assembly is positioned within the adapter, the stopper has a perimeter that forms a friction fit with the adapter. The friction fit allows the stopper to maintain the collection / discard tube in a spaced relationship with the adapter needle.

[0079] Fig.57 Another aspect of the assembly is to maintain the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and to allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, a removable clamp, tear-away strip, or fixture is used to force the spaced relationship between the sleeve in which the collection / discarding tube is disposed and the adapter. The spaced relationship ensures that the collection / discarding tube does not engage the adapter needle during storage and shipping. When sample collection begins, the clamp or fixture is removed and the sleeve in which the collection / discarding tube is disposed can be advanced into contact with the adapter needle for sample collection. After sample collection, the collection / discarding tube (still disposed in the sleeve) is removed from the adapter.

[0080] Figure 58A-Figure 58C A three-piece assembly for maintaining a collection / disposal tube in a spaced relationship with a needle in an adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. When the collection / disposal tube is removed from the adapter, the three-piece assembly is pulled therefrom. A retaining ring with an upwardly facing extension fits into the base of the adapter. A sleeve with first and second flanges fits over the collection / disposal tube. The collar is placed adjacent to the cap on the collection / disposal tube, and the collar is sized to be advanced over the retaining ring, which allows the collection / disposal tube to remain spaced from the adapter needle during shipping and storage. When the first flange passes over the retaining ring, the collection tube engages with the needle for sample collection. When the collection / disposal tube is removed from the adapter, the first flange on the sleeve cooperates with the collar to pull the retaining ring therefrom.

[0081] Fig.59 A proof of concept illustration of using an elastomeric tube to hold a collection / discard tube in a spaced relationship with a needle in an adapter during shipping but allowing the collection / discard tube to be advanced into engagement with the needle for sample collection. When the elastomeric tube is removed, the collection / discard tube can be engaged with the adapter needle for sample collection. When the desired amount of sample is collected, the collection / discard tube is removed from the adapter.

[0082] Fig.60A proof of concept illustration of using an extension extending from a sleeve on a collection / disposal tube to keep the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. When the collection / disposal tube is advanced into engagement with the adapter needle for sample collection, the extension is brought into the adapter. When the collection / disposal tube is removed from the adapter, the extension is taken away with it.

[0083] Fig.61 yes Fig.60 A further modification of the illustrated aspect, also a proof of concept illustration of using an extension extending from a sleeve on a collection / disposal tube to hold the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. A band is used to hold the sleeve together. In certain aspects, the cardboard is corrugated to increase thickness and robustness. When the collection / disposal tube is advanced into engagement with the adapter needle for sample collection, the extension is brought into the adapter. When the collection / disposal tube is removed from the adapter, the extension is taken away with it.

[0084] Fig.62 yes Fig.60 A further modification of the illustrated aspect is also a proof of concept illustration of using an extension extending from a sleeve on a collection / discard tube to hold the collection / discard tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / discard tube to be advanced into engagement with the needle for sample collection. A band is used to hold the sleeve together and hold the collection / discard tube in a spaced relationship with the adapter needle. In certain aspects, the cardboard is corrugated to increase thickness and sturdiness. When collection is initiated, the band holding the collection / discard tube in place is removed, allowing the collection / discard tube to be advanced into engagement with the adapter for sample collection, and the extension is brought into the adapter. When the collection / discard tube is removed from the adapter, the extension is taken away with it.

[0085] Fig.63 is a conceptual illustration of a sleeve structure for a collection / disposal tube that is wide enough not to enter the adapter, thereby keeping the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. The collection / disposal tube can be advanced in the sleeve structure. After sample collection, squeezing the structure allows the collection / disposal tube assembled to the sleeve to exit the adapter.

[0086] FIG64 is a conceptual illustration of a sleeve structure for a collection / disposal tube that is wide enough not to enter the adapter, thereby keeping the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection when the sleeve is squeezed. The collection / disposal tube can then be advanced in the sleeve structure. After sample collection, the structure is squeezed to allow the collection / disposal tube assembled to the sleeve to be withdrawn from the adapter.

[0087] Figure 65A-Figure 65B The invention is a valve assembly having a first adapter for receiving a collection / disposal tube and at least one other adapter for receiving a sample bottle. The assembly has an inlet that can be connected to a tubing set for collecting a sample from a patient. The valve can direct a first portion of the collected sample into the collection / disposal tube. After the desired amount of sample is collected, the valve is rotated and additional sample is directed to one or more sample containers.

[0088] Fig.66 yes Figure 65A-Figure 65B In this aspect, a pin is provided to prevent the valve from rotating beyond a position that would direct the sample out of the sample collection / disposal tube adapter unless the collection / disposal tube is engaged with a needle in the adapter.

[0089] Figure 67A-Figure 67B An alternative aspect of the assembly described herein is shown, which deploys a collection / discard tube to communicate with an adapter for connection to a patient line set to collect a sample from a patient into a container. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle during shipping and storage. The collection / discard tube may have one of the many examples of a collar or sleeve or band described herein for maintaining such a spaced relationship between the collection / discard tube and the needle. The adapter has a valve on its end, which is placed to connect to a patient line set (not shown). The collection / discard tube is pushed into the adapter to collect the sample, after which the valve is opened. Once the initial portion of the patient sample is collected in the collection / discard tube, the collection / discard tube is removed from the adapter, and then the patient sample collection bottle is placed in fluid communication with the adapter needle for collecting the patient sample into a blood culture container.

[0090] Figure 68A-Figure 68BAn alternative aspect of the assembly described herein is shown, which deploys a collection / discard tube to communicate with an adapter for connection to a patient line set to collect a sample from a patient into a container. In this aspect, the collection / discard tube is assembled with the adapter, but is maintained in a spaced relationship with the adapter needle by rotating a flap during shipping and storage. The adapter has a first port for receiving the collection / discard tube and a second port for receiving a blood culture bottle. The flap moves from a first position, the first position being located in the middle between the collection / discard tube and the adapter needle, thereby preventing the collection / discard tube from contacting the adapter needle during shipping and storage, to a second position, in which the flap is positioned alongside the collection / discard tube and is therefore no longer in the path between the collection / discard tube and the adapter needle. The collection / discard tube is advanced in the adapter, causing the flap to move from the first position to the second position. The collection / discard tube is advanced into the adapter to collect the sample, after which the valve is opened. Once the initial portion of the patient sample is collected into the collection / disposal tube, the collection / disposal tube is removed from the adapter and the patient sample collection bottle is placed in fluid communication with the adapter needle in the larger port for collection of the patient sample into the blood culture container.

[0091] Figure 69A-Figure 69B Show Figure 68A-Figure 68B An alternative aspect of the dual-port adapter described in . The assembly described herein deploys a collection / discard tube to communicate with the dual-port adapter for connection to a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle during shipping and storage by a ring or other mechanism described herein. The adapter has a first port for receiving the collection / discard 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 in the port receiving the collection / discard tube is positioned on the pin in the second port. In this position, the pin cannot move upward and the culture bottle cannot contact the needle in the second port. When the collection / discard tube is advanced into fluid communication with the needle in the adapter, the lever moves away from above the pin and the pin can move upward, thereby allowing the culture bottle to be placed into fluid communication with the needle in the second port for collecting the rest of the sample. Once the initial portion of the patient sample is collected into the collection / disposal tube, the collection / disposal tube is removed from the adapter and the patient sample collection bottle is placed in fluid communication with the adapter needle in the larger port for collection of the patient sample into the blood culture container.

[0092] Figure 70A-70B Show Figure 69A-Figure 69BAn alternative aspect of the dual-port adapter described in . The assembly described herein deploys a collection / discard tube to communicate with the dual-port adapter for connection with a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle by a ring or other mechanism described herein during shipping and storage. The adapter has a first port for receiving the collection / discard tube and a second port for receiving a blood culture bottle. The adapter also has a needle shuttle that will move the needle from the first port to the second port. A lock out peg prevents the needle from moving from the first port to the second port until the sample is collected in the collection / discard tube in the first port. When the collection / discard tube is advanced into communication with the needle fluid in the adapter, the lock out peg is moved upward, which allows the needle shuttle to move. Moving the needle shuttle will move the needle from the first port to the second port. The culture bottle can then be placed in communication with the needle fluid in the second port for collecting the rest of the sample. Once the initial portion of the patient sample is collected into the collection / disposal tube, the collection / disposal tube is removed from the adapter and the patient sample collection bottle is placed in fluid communication with the adapter needle in the larger port for collection of the patient sample into the blood culture container.

[0093] Fig.71 Show Figure 70A-70B An alternative aspect of the dual-port adapter described in . The assembly described herein deploys a collection / discard tube to communicate with the dual-port adapter for connection with a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle by a ring or other mechanism described herein during shipping and storage. The adapter has a first port for receiving the collection / discard tube and a second port for receiving a blood culture bottle. The adapter also has a needle shuttle that will move the needle from the first port to the second port. In this aspect, the assembly lacks a locking pin. Once the initial portion of the patient sample is collected into the collection / discard tube, the collection / discard tube is removed from the adapter, which allows the needle shuttle to move from the first port to the second port, and then the patient sample collection bottle is placed in fluid communication with the adapter needle in the larger port for collecting the patient sample into the blood culture container. Moving the needle shuttle will move the needle from the first port to the second port. The culture bottle can then be placed in fluid communication with the needle in the second port for collecting the rest of the sample.

[0094] Figure 72A-72BAn alternative aspect of a dual-port adapter is shown. The assembly described herein deploys a collection / discard tube to communicate with a dual-port adapter for connection with a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle by a ring or other mechanism described herein during shipment and storage. The adapter has a first port for receiving a collection / discard tube and a second port for receiving a blood culture bottle. The adapter also has a rotary valve, which in one position will allow a patient sample to flow into the collection / discard tube, and in a second position will allow a patient sample to flow into the blood culture bottle. Initially, before the sample is collected, the rotary valve is in a third position ("closed" position). When the collection / discard tube is in fluid communication with the needle in the adapter, the rotary valve is moved to the first position. Once the initial portion of the patient sample is collected in the collection / discard tube, the collection / discard 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 in fluid communication with the adapter needle.

[0095] Fig.73 yes Figure 72A-72B An alternative aspect of the invention wherein the adapter has a locking pin that requires the blood culture bottle to be inserted into the adapter before the rotary valve is moved to the third position.

[0096] Figure 74A-Figure 74B An alternative aspect of a dual port adapter is shown. The assembly described herein deploys a collection / discard tube to communicate with a dual port adapter for connection with a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle by a ring or other mechanism described herein during shipment and storage. The adapter has a first port for receiving the collection / discard tube and a second port for receiving a blood culture bottle. These ports are staggered so that the collection / discard tube can be placed in one port and the culture bottle can be placed in another port at the same time, thereby providing a pressure difference between the flow path leading to the collection / discard tube and the flow path leading to the culture bottle. When the collection / discard tube is connected to the needle fluid in the adapter, the sample is collected in the sample collection / discard tube. Once the initial portion of the patient sample is collected in the collection / discard tube, the blood culture bottle is placed in communication with the needle fluid in the second port. Because the second port is lower than the first port (or more precisely, because the sample collection tube is held higher in the adapter than the blood culture set), the sample preferentially flows to the blood culture set when both the collection / disposal tube and the culture bottle are connected in the adapter.

[0097] Fig.75is one aspect of a dual port adapter in which a sample collection / disposal tube is held in a spaced relationship with a needle in the adapter by various mechanisms described herein (eg, a rubber ring, a clutch, a fastener, or other spacing mechanism). Fig.75 Shown with Fig.71 A universal separation mechanism integrated with the sliding needle shuttle described in.

[0098] Fig.76 An adapter is shown in fluid communication with a sample collection / disposal tube. The adapter has a piezoelectric flow monitor that will indicate to the user when the sample collection / disposal tube contains a target amount of sample.

[0099] Fig.77 is an alternative aspect of a dual port adapter. Each port is attached to one end of a "Y" shaped connector. The port that receives the sample collection / disposal tube has a retaining mechanism that holds the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping and storage. When the sample collection / disposal tube is placed in fluid communication with the needle in the adapter port, the line from the tubing set to the "Y" connector is primed. When the sample is collected into the sample collection / disposal tube, the sleeve on the needle in the second port acts as a shut off valve. When the 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.

[0100] Fig.78 yes Fig.77 An alternative aspect of a dual port adapter of the present invention. Each port is attached to one end of a "Y" shaped connector, and the ports themselves are arranged in a "Y" shape. The port that receives the sample collection / discard tube has a retaining mechanism that holds the collection / discard tube in a spaced relationship with the needle in the adapter during shipping and storage. When the sample collection / discard tube is placed in fluid communication with the needle in the adapter port, the line from the tubing set to the "Y" connector is primed. When the sample is collected into the sample collection / discard tube, the sleeve on the needle in the second port acts as a shutoff valve. 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 because the requisite amount of sample is in the collection / discard tube. DETAILED DESCRIPTION

[0101] The various embodiments of the present disclosure are described in detail with reference to the accompanying drawings, wherein the same reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. Well-known functions or configurations are not described in detail to avoid unnecessary details from obscuring the present disclosure. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but only as the basis for the claims and as a representative basis for teaching those skilled in the art to adopt the present disclosure in various ways with almost any appropriate detailed structure.

[0102] refer to Figure 1 , shows a side cross-sectional view of a sample collection system 100 according to the present technology. Figure 1 The sample collected by the system can be a fluid, such as blood drawn from a patient. Figure 1 The system includes: a container 102 (e.g., a bottle or tube) for collecting or storing a collected sample; and an adapter 150, which is configured to fluidly couple a collection container (e.g., container 102) fluidly coupled to the adapter to a tubing set (e.g., a venipuncture needle and tubing coupled to a patient) for receiving a sample therefrom. The container 102 is shown as a tube having an open end 104A and a closed end 104B. The container 102 also includes a cap or stopper 106 including a septum. The cap 106 is coupled to the open end 104A and seals the interior of the container 100 from being in fluid communication with the environment outside the container 100. The container 102 may also include a shield 108 disposed around the cap 106 to protect the cap 106 from damage during use. The adapter 150 includes a distal end 154A, a proximal end 154B, a body 160 (e.g., configured to be substantially tubular), and a needle 158. The adapter 150 has a connector 152 (shown as a Luer connector) at a distal end 154A of the adapter 150. A needle 158 is mounted to and in fluid communication with the connector 152. The needle 158 extends from the connector 152 in a proximal direction into an interior 156 of the adapter 150. The proximal end 154B of the adapter 150 includes an opening that provides access to the interior 156 and is configured to receive the end 104A of the container 102.

[0103] Sample collection device (sample collection) Figure 1158 is manufactured and shipped in the configuration shown. In this configuration, the container 102 remains separated from and not engaged with the needle 158. This 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 into the interior 156 from the end 154B of the adapter 150 from the first position to the second position. As described above, in the first position, the cap 106 is in a spaced relationship (e.g., at a predetermined distance) with the proximal end of the needle 158 and is 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., in this case the needle 158 pierces the septum of the cap 106). In addition, the connector 152 is also coupled to a corresponding tubing set connector and a tubing set needle, wherein the tubing set needle is used for venipuncture to collect a blood sample from a patient. It should be understood that in some embodiments, the connector 152 can be a female connector that can be connected to a tubing set. Adapter Male Adapter or connector, however, other types of connectors for use with adapters and containers (eg, adapter 150 and container 102) are also contemplated within the scope of the present disclosure, such as a catheter in place of a line set.

[0104] Container 102 is a sealed container, and its internal pressure is a complete vacuum or a partial vacuum (i.e., negative pressure). When needle 158 pierces cap 106, the negative pressure inside container 102 draws the initial portion of blood from the patient into the interior of container 102 via tubing set, connector 152 and needle 158. After the initial portion of the patient sample is collected, container 102 is then withdrawn proximally from the interior 156 of adapter 150 so that needle 158 is disconnected from the fluid communication with the interior of container 102. Once needle 158 is no longer in fluid communication with the interior of container 102, blood flow from the patient stops. Container 102 is discarded together with the initial portion of blood collected therein. At this point, a second container (e.g., a blood culture bottle) is pushed into the interior 156 of adapter 150 to draw blood from the patient. The internal pressure of the second container is also negative pressure. The blood drawn into the second container will be used as blood to be tested to determine whether the patient's blood contains microbial contamination.

[0105] In some embodiments, Figure 1 The blood collection system can be used with Becton, Dickinson and Company ("BD") This can be done with one of the blood collection kits, such as BD's Button blood collection kit, BD Safety-Lok TM Blood collection kit or BD UltraTouch TMTherefore, in some embodiments, the adapter 150 can use BD In addition, in some embodiments, the adapter 150 can also use BD's A disposable retainer is used to achieve this.

[0106] As described above, most organisms identified as contaminants in blood cultures come from the patient's skin. These contaminants are generally introduced into the patient's blood sample through venipuncture and the initial flow of blood from the patient to a container or collection bottle (such as container 102). In the sample collection system 100 described herein, an initial portion of blood collected from the patient is contained in a first container 102, which is then discarded. Then, a second portion of the blood collected from the patient is collected in a second container and stored for subsequent testing. Therefore, the sample collection system 100 described herein potentially reduces the number of false positive blood cultures that may produce false positives due to the presence of microbial contamination of the sample from the patient's skin by discarding the first portion of the collected sample.

[0107] According to the present technology, a securing mechanism is provided that is configured to releasably hold or secure a container (e.g., container 102) to an adapter (e.g., adapter 150) in a first position (i.e., a spaced relationship in which container 102 is not engaged with needle 158 of adapter 150). In this manner, container 102 and adapter 150 can be shipped to a user or technician as an assembled unit, wherein container 102 is held in the first position relative to adapter 150 by the securing mechanism. After the technician connects the tubing set to the patient and adapter 150, the securing mechanism is configured to allow container 102 to be advanced from the first position to the second position. As described above, in the second position, needle 158 of adapter 150 pierces the seal of container 102, and negative pressure in container 150 draws a patient sample into container 102 through the tubing set, connector / needle 158. After blood is collected from the patient into container 102, the operator can remove container 102 from adapter 150. The securing mechanism is also configured to be removed with the container 102 when the container 102 is removed from the adapter 150 by an operator.

[0108] For example, Figure 1 The system may include a fixing mechanism 110 configured with the above-mentioned features. Figure 1As shown, the fixing mechanism 110 includes a distal end or distal portion 112 and a proximal end or proximal portion 114. The fixing mechanism 110 can be made of rubber and configured in a ring shape. The fixing mechanism 110 is arranged around the outside of the container 102. The distal portion 112 has a predetermined thickness (between the outer diameter of the portion 112 and the inner diameter shared by the portions 112 and 114), and the predetermined thickness is selected so that the portion 112 can fit between the outside of the container 102 and the inner wall 160 of the adapter 150 defining the inner diameter. In addition, the proximal portion 114 is configured as an edge or flange having a predetermined thickness (between the outer diameter of the portion 114 and the inner diameter shared by the portions 112 and 114), and the predetermined thickness is selected to be greater than the predetermined thickness of the portion 112 so that the outer diameter of the portion 114 is greater than the inner diameter of the adapter 150. In this way, the predetermined thickness of the portion 114 ensures that the fixing mechanism 110 is retained at the proximal end of the adapter 150 without being advanced distally into the interior 156 of the adapter 150.

[0109] The predetermined thickness of portion 112 is also configured to provide a sufficient amount of friction between the inner diameter of portion 112 of securing mechanism 110 and the outer diameter of container 102 such that container 102 is releasably secured or retained in the first position (e.g., Figure 1 156) and will not move relative to the adapter 150 in the absence of a user-applied force to the container 102. From the first position, the user can advance the container 102 in the distal direction against the friction force applied by the securing mechanism 110 into the second position, so that the septum seal of the cap 106 of the container 102 is caused to engage with and be pierced by the needle 158. Because, as described above, the predetermined thickness of the portion 114 prevents the portion 114 from being advanced distally into the interior 156 of the adapter 150, the securing mechanism 110 is retained at the proximal end 154B of the adapter 150 when the container 102 is advanced from the first position to the second position. After the initial portion of the blood sample is drawn from the patient-user into the container 102 (in the manner described above), the operator or user pulls the container 102 proximally to remove the container 102 from the adapter interior 156. As the container 102 is withdrawn from the interior 156 , the securing mechanism 110 remains disposed about the exterior of the body 102 and is also pulled away from the adapter 150 as the container 102 is removed from the adapter 150 .

[0110] It should be understood that in addition to the above-mentioned fixing mechanism 110, the fixing mechanism of the present technology can also take other forms. Figure 2A, a securing mechanism 210 is shown for use in a sample collection system 100 according to the present technology. The securing mechanism 210 is configured as a c-clip that is configured to be disposed about the outer diameter of the body 102 of the container 100. A gasket, washer, o-ring, or the like 212 is provided to provide an interference fit between the adapter 150 and the container 102. The c-clip 210 may be made of rubber and include a predetermined thickness (between the inner diameter and the outer diameter of the c-clip) that is configured to provide sufficient friction to hold or secure the container 100 in a first position (as shown in FIG. 2 ) such that the container 100 does not move relative to the adapter 150 from the first position in the absence of a force applied by a user or technician. As described above, the technician may advance the container 102 distally to the second position after venipuncture so that the tubing set is in fluid communication with the connector 152 and the needle 158 of the adapter 150. In the second position, the needle 158 pierces the septum seal of the cap 106. The negative pressure in the container 102 draws an initial portion of blood from the patient into the container 102. Thereafter, when a sufficient volume of the initial portion has been collected to ensure that microbial skin contaminants are collected with the initial portion, the technician pulls the container 102 proximally 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-clip 210 remains disposed about the outer diameter of the container 102, such that removing the container 102 from the interior 156 also removes the c-clip 210 from the interior 156. In one aspect, when the container 102 is removed from the adapter, the c-clip 210 and the gasket / washer / O-ring 212 are also removed. According to this aspect, the outer diameter of the shield 108 can be greater than the inner diameter of the c-clip 210. In this way, when the container 102 is withdrawn proximally to remove the container 102 from the interior 156, the proximal end of the shield 108 contacts the c-clip 210 and the gasket / washer / O-ring 212 to pull the c-clip 210 and the gasket / washer / O-ring 212 together with the container 102 from the interior 156 of the adapter.

[0111] As another example, see Figure 3A , Figure 3B , the fixing mechanism 310 is shown for use in a sample collection system 100 according to the present technology. Figure 3AAs shown, the fixing mechanism 310 can form a snap fit with the shield 308 of the container 102. On the proximal end of the shield 308, the edge 309 protrudes in a direction away from the outside of the container 102. In addition, the fixing mechanism 310 is also configured in a ring shape and is arranged around the outside of the container 102. The fixing mechanism 310 includes edges 312 and 314 extending oppositely. The edge 312 is arranged on the distal end of the fixing mechanism 310 and protrudes to the outside of the container 102 (i.e., in the opposite direction to the protrusion of the edge 309). The edge 314 is arranged on the proximal end of the fixing mechanism 310 and protrudes away from the outside of the container 102. The outer diameter of the fixing mechanism 310 from the distal end to the position of the proximal edge 314 is selected so that the distal portion of the fixing mechanism 310 can be inserted into the interior 156. The edge 314 extends beyond the inner diameter of the adapter defined by the inner surface 160 and acts as a stop or flange at the proximal end 154B. In this manner, the rim 314 prevents the securing mechanism 310 from being advanced distally into the container 150 beyond the position where the rim 314 is adjacent and engaged with the proximal end of the adapter and retains the securing mechanism 310 at the proximal end 154B of the adapter 150 .

[0112] In use, the end 104A of the container 102 is inserted into the interior 156 through the hole of the fixing mechanism 310 and advanced distally until the edge 312 contacts the edge 309 and the edge 314 contacts the distal end 154B of the adapter 150, as shown. Figure 3B As shown. The edges 312 and 314 are arranged at a predetermined distance from each other so that Figure 3B In the illustrated arrangement, the container 100 is releasably secured or held in a first position relative to the adapter 150 by the interlocking of the edges 309, 312 (and the edge 134 abutting the end 154B), thereby preventing the container 102 from being advanced distally within the interior 156. The edge 312 and / or edge 309 are configured to deform slightly under a predetermined amount of force, so that a user applying a distal force to the container 100 can force the edge 309 distally beyond the edge 312 (edge ​​312 being held stationary relative to the adapter 150 due to the interaction of the edge 314 with the end 154B) to advance the container 100 from the first position to the second position so that the needle 158 pierces the septum of the cap 106. During the process of distal advancement of the container 102, the interaction between the edge 314 and the distal end 154B holds the securing mechanism 310 at the distal end 154B of the adapter 150. When container 102 is removed from interior 156 by withdrawing container 100 proximally, edge 309 again contacts edge 312 and pulls securing mechanism 310 proximally to remove securing mechanism 310 from adapter 150. As container 102 is pushed out of adapter 150, edge 314 is pushed away from proximal end 154B of adapter 150.

[0113] As another example, see Figure 4, a securing mechanism 410 is shown for use with a sample collection system 100 according to the present technology. Figure 4 In the system, the fixing mechanism 410 is configured as a compressible spring attached to the cap and / or shield 108 at the end 104A of the container 102. The spring 410 is releasably attached to the interior 156 of the adapter 150, for example, to the distal surface 162 of the adapter 150 (e.g., Figure 4 162 and the cap 106. The spring 410 is configured to bias the container 102 in the first position so that the needle 158 and the cap 106 are in a spaced relationship and not engaged. Figure 4 When the system is ready for use (i.e., the tubing set is connected to the patient and the connector 152), the technician can push the container 100 distally against the tension of the spring 410 from the first position to the second position, in which the needle 158 engages the cap 106 (i.e., the needle 158 pierces the septum of the cap 106) and blood is drawn into the container 1020. It should be understood that in order 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 pushes the container 100 proximally to the second position to automatically disengage 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 the shield 108 , the spring 410 is also removed from the interior 156 upon removal of the container 100 .

[0114] Figure 5A-5D Another aspect of the assembly is shown with a securing mechanism 510 that keeps the collection / disposal tube 102 spaced from the adapter needle 108 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 108 in the adapter 150 for sample collection. Figures 5A-5C1 shows a foam rubber flange as a securing mechanism 510 that provides the desired separation during shipping and storage and remains attached to the discard tube 102 when removed from the adapter 150. In one example, the securing mechanism 510 includes portions 512, 514, which can be configured with the same features as described above with respect to portions 112, 114 of the securing mechanism 110. In this manner, portions 512, 514 of the securing mechanism 510 provide an interference fit between the collection / disposal tube 102 and the foam 510 and the adapter 150. The interference fit holds the tube 102 in place relative to the adapter 150 (e.g., in a spaced relationship in the first position), but allows the tube 102 to easily move toward the needle 158 when an advancement force is applied. Portion 514 has a predetermined thickness that is greater than the inner diameter of the adapter 150 to ensure that the securing mechanism 510 is retained at the proximal end of the adapter 150 and is not advanced 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 fixing mechanism 510 includes one or more protrusions 516, 518. The protrusion 516 in the foam 510 is configured to protrude radially inward from the inner diameter of the foam 510 (defined by the inner diameter of the portions 512, 514) to control the interference force between the tube 102 and the foam 104. The protrusion 518 can also be on the outer diameter of the portion 512 on the adapter side of the foam rubber flange 510. The point 520 on the collection / disposal tube 102 shows an optional feature in which a drop of adhesive can be provided to snap into the receiving hole in the foam flange to attach it to the collection / disposal tube 102.

[0115] Figure 6 Another aspect of the assembly with a securing mechanism 610 that holds the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. As shown, a side view of the sample / collection discharge tube 102 has a foam rubber flange 610 that is friction fit on the discard tube 102, and when the tube 102 is removed from the adapter 150, the foam rubber flange 610 is pulled from the adapter 150. The foam rubber flange 610 has a low-tack adhesive to attach the flange 610 in the base 154B of the adapter 150 (e.g., the flange at one end). The tabs define the spaced relationship between the discard tube 102 and the cap 106 thereon. In one aspect, the adhesive strength can be selected so that when the tube 102 is pulled out of the adapter 150, the cap 106 applies a pulling force to the securing mechanism 610 when the cap 106 contacts the securing mechanism 610. The pulling force is sufficient to overcome the adhesion between the securing mechanism 610 and the base or flange 154B to decouple the mechanism 610 from the base or flange 154B. In this way, the securing mechanism 610 is taken away from the adapter 150 as the tube 102 is removed.

[0116] Figure 7 Another aspect of the assembly according to the present disclosure is a securing mechanism 710 that maintains the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. Figure 7 Shown in FIG. 1 is an alternative foam friction fit collar 710 disposed about the collection / disposal tube 102. The collar 710 does not have Figure 5A-5D and Figure 6 The collar 710 is configured with the friction fit features described above with respect to the above-described securing mechanisms (e.g., securing mechanisms 110, 510, etc.). In one aspect, the collar 710 can be affixed (e.g., using a low-tack adhesive or using one or more fixations—described below) to the exterior of the tube 102 to prevent accidental translation of the tube 102 before the user pushes the tube 102 into the adapter 150.

[0117] Fig. 8A An alternative mechanism to provide a friction fit to the flange / O-ring assembly that separates the discard tube from the adapter needle during shipping. In this aspect, the O-ring is positioned below the cap and has a friction fit within the adapter so that the discard tube is slidably engaged in the adapter. A retainer is provided to secure the discard tube in its shipping position. The retainer is labeled as such.

[0118] Figure 8B The invention is an improved cap or stopper with an O-ring disposed in a groove for slidable engagement of the cap in the adapter. The O-ring provides a friction fit in the adapter.

[0119] Figure 8C A sample collection system is shown having Figure 8B A cap in the adapter and a fastener located at the flange of the adapter base, the fastener secures the collection / disposal tube in a spaced relationship with the adapter needle.

[0120] Figure 9A-9I The operation of the sample collection / disposal tube in the adapter is shown. The sample collection / disposal tube has a sleeve fitted thereon with a flange to receive an O-ring which secures the sample collection / disposal tube from engaging the needle in the adapter during shipping but allows the collection / disposal tube to slide into engagement with the needle for sample collection and then be removed from the adapter after sample collection.

[0121] Figure 10A-10BAnother aspect of the assembly with a securing mechanism 1010 maintains the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. In this regard, Figure 10A-10B The aspects shown are Figure 13A-13B The aspects shown are relevant. Figure 10A-10B Specifically shown is a ring as the securing mechanism 1010. The ring 1010 may be made of rubber. The rubber ring 1010 includes (ring-shaped) portions 1012, 1014. The portion 1014 has a predetermined outer diameter, which is configured to provide an interference fit with the inner diameter of the bottom end opening of the adapter 150. The inner diameter of the portion 1012 (which defines the inner diameter of the ring 1010) is configured to snugly receive the collection tube 102 to ensure that it remains spaced apart from the needle 158 in the adapter 150 during shipping. On the one hand, the portion 1012 extends distally from the portion 1014 and has a diameter that tapers distally. The portion 1012 is configured (via its inner diameter and shape) to allow the tube 102 to be easily advanced into the adapter 150 in only a single direction when a pushing force is applied - such as Fig. 10B As shown - so that the collection / disposal tube 102 can be advanced into engagement with the needle 158 for sample collection. After sample collection, the rubber ring 1010 is pulled out of engagement with the adapter 150. When a pulling force is applied to the tube 102 to remove the tube 102 from the adapter 150, the portion 1012 catches or snaps on the outside of the tube 102 and causes the ring 1010 to disengage from the adapter 150 and the tube 102 and the ring 1010 are pulled out of the adapter 150 together. The ring 1010 is configured as a one-way ratchet mechanism.

[0122] Fig.11 A fixing mechanism 1110 is shown, which is Figure 10A-10B 110. The rubber ring or securing 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 manner described above. The portions 1112 and 1114 each include an inner diameter. The inner diameter of the portion 1112 is smaller than the inner diameter of the portion 1114 and is selected to receive and clamp the flange 1122 of the sleeve 1120 disposed on the tube 102 to maintain the tube 102 in a spaced relationship with the needle 158 within 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 / disposal tube 102 is pulled and removed from the adapter 150, the rubber ring 1110 is pulled out of the adapter 150 by the flanged ring 1120.

[0123] Fig.12The fixing mechanism 1210 is shown as another alternative configuration of a rubber ring disposed in the bottom of the adapter 150. Figure 10A-10B and Fig.11 154B of the adapter 150. In one 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 outer diameter and inner diameter of the ring 1210 are 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 extending 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 clamp the outside of the tube 102 to hold the tube 102 in place. When a thrust is applied to the tube 102 entering the adapter 150, the ring 1210 and the bearing 1212 are configured to easily allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150. In one aspect, the rubber ring 1210 is prevented from being advanced into the adapter 150 by a flange or stepped end 1250 in the inner diameter of the open proximal end 154B of the adapter 150. The inner diameter of the stepped end 1250 matches the outer diameter of the ring 1210. The surface 1216 of the ring 1210 abuts the surface or ledge 1252 of the stepped end 1250 to prevent the ring 1210 from being pushed into the adapter 150. When the tube 102 is pulled or pushed out of the adapter 150, the rubber ring 1210 is removed from the adapter 150. In one aspect, when the tube 102 is pulled out of the adapter 150, the ring 1210 (e.g., due to the clamping ring 1214 and the surrounding material of the ring 1212) is configured to clamp the ball bearing 1212 so that the clamping force of the ring 1210 on the tube 102 increases and the ring 1210 disengages from the adapter 150 and is pulled out of the adapter 150 together with the tube 102.

[0124] Figure 13A-13B Another aspect of the assembly is a securing mechanism 1310 that maintains the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. Figure 13A-13B The securing mechanism is shown as a ratchet collar 1310 having tabs 1312 extending from a flanged portion 1314. Tabs 1312 are spaced around the inner circumference of collar 1310 and extend distally from flanged portion 1314. The central opening of collar 1310 receives tube 102, and tabs 1312 provide an interference fit for collar 1310 and tube 102 in adapter 150 so that a collection / disposal tube can be advanced through collar 1310. Fig.13AAs shown, at least a portion of each fin 1312 extends in a direction toward the center of the central opening of the collar 1310. When the tube 102 is pushed into the adapter 150, the flanged portion 1314 of the collar 1310 abuts the open proximal end of the adapter 150 to hold the adapter 150 in place. Fig. 13B As shown, the collar 1310 remains in place when the tube 102 is advanced into engagement with the adapter needle 158. The collar 1310 allows the collection / disposal tube 102 to be freely advanced toward the needle 158, but the tabs 1312 of the collar 1310 are configured to grip and bundle around the outside of the tube 102 as the collection / disposal tube 102 is pulled away from the needle 158. Thus, when the collection / disposal tube 102 is pulled from the adapter 150, the collar 1310 is removed from the adapter 150. In one aspect, as shown in FIG. Figure 13A-13B As shown, the tab 1312 can be supported by a ring or edge 1312 extending distally from the flanged portion 1314. Figure 10A-10B , Fig.12 , Figure 14A-Figure 1 4D, Figures 15A-15D and Figures 16A-16E An alternative to this configuration is described in . In this manner, collar 1310 resembles a one-way ratchet mechanism, allowing tube 102 to be easily advanced into adapter 150, but catching and gripping tube 102 when tube 102 is pulled out.

[0125] Figure 14A-Figure 1 4D is another aspect of the assembly with a securing mechanism 1410 that maintains the collection / disposal tube 102 and adapter needle 158 in a spaced relationship during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. Figure 14A-Figure 1 4D is Figure 13A-13B Another alternative to . Figure 14A-Figure 14D shows the securing mechanism as a one-way collar 1410. The collar 1410 includes a tubular or barrel-shaped portion 1414 and a flanged portion. The collar 1410 includes an inner gripping portion 1416 disposed on the inner surface of the portion 1414 and extending therefrom. When the tube 102 is received inside the portion 1414, the gripping portion 1416 provides a friction force for gripping the exterior of the tube 102. The gripping portion 1416 is configured to hold the tube 102 in place (e.g., in a spaced relationship with the needle 158) and allow the collection / disposal tube 102 to be advanced into the adapter 150 when a pushing force is applied to the tube 102. As shown in FIG. 14D, the gripping portion 1416 of the collar 1410 grips the tube 102 so that when the collection / disposal tube 102 is pulled from the adapter 150, the tube 102 is removed from engagement with the adapter 150. The flanged portion 1412 of the collar 1410 has a catch 1418 that receives a flange at the base or open proximal end of the adapter 150. The catch 1418 may form all or part of the outer edge or circumference of the flanged portion 1412. The grip 1416 grips the exterior of the tube 102 so that the seal / coupling of the catch 1418 to the base of the adapter 150 is broken when the tube 102 is pulled from the adapter 102. The catch 1418 may be made of a soft material (TPE) so that the seal / coupling to the flanged base of the adapter 150 can be broken and disengaged from the adapter 150 when the tube 102 is pulled out of the adapter 150.

[0126] Figures 15A-15D Show Figure 13A-13BThe one-way collar 1510 is an alternative fixing mechanism 1510 of the collar 1310 of the embodiment of the present invention and operates in a similar manner. The one-way collar 1510 in this aspect has portions 1512 and 1514. Portion 1512 includes a ratchet or catch 1518 that engages with the base of the adapter 150 in a manner similar to the description above regarding catch 1418. Thus, in this aspect, the collar 1510 does not have an interference fit with the adapter 150. Due to the impact 1520 in the ratchet 1518 on the collar 1510, the collar 1510 cannot be pushed upward into the adapter 150. The collar 1510 includes a gripping portion 1516 that extends upward (distal) from the inner wall of portion 1514 and toward the center of the interior of portion 1514. The gripping portion 1516 acts as a one-way ratchet mechanism on the tube 102. In use, the collar 1510 is disposed around the tube 102, and the grip 1516 grips the exterior of the tube 102, and the ratchet 1518 engages with the base of the adapter 1510 to hold the tube 102 in a spaced relationship with the needle 158. The grip 1516 is configured to allow the tube 102 to be easily moved toward the interior of the adapter 150 and engaged with the needle 158 with relatively low pushing forces. In addition, the grip 1516 is configured to bunch and provide high resistance or friction on the exterior of the tube 102 when the tube 102 is pulled toward the exterior of the adapter 150. Fig. 16B , Fig. 16C and Figure 16E-16K The operation and bundling of the gripper 1616 of a similar configuration in FIG. 1 is shown as an example of the operation and bundling occurring at the gripper 1516. The gripper 1516 holds the collection / disposal tube 102 so that the ratchet 1518 can be detected from the base of the adapter when the tube 102 is removed or pulled from the adapter 150. Thus, by pulling on the tube 102, both the collar 1510 and the tube 102 are removed from the adapter 150.

[0127] Figures 16A-16D An alternative securing mechanism 1610 of the collar of FIG. 15 is shown, wherein a fastener 1650 is added to secure the collar 1610 to the collection / disposal tube 102 when in the shipping / storage position. The collar 1610 includes portions 1612, 1614 configured with similar features to the portions 1512, 1514 described above. The bumper and ratchet 1618 are positioned relative to Figures 15A-15D Shown rotated 90 degrees.

[0128] Figure 16E-16K Show Figures 16A-16DThe upward facing grip 1618 makes it possible to push the collection / disposal tube 102 upward into the adapter 150, but when the collection / disposal tube 102 is pushed out of the adapter 150, it takes the collar 1610 away from the adapter 150 along with the tube 102. The grip 1616 acts as a one-way grip so that the tube 102 can be pushed upward through the grip, but when pushed outward from the adapter, the tube 102 takes the collar 1610 away.

[0129] Figure 17A-17B It is a two-piece fixing mechanism. Figures 17A-17B The fixing mechanism 1710 shown includes rings 1711 and 1721. Variations in this aspect are Figures 18A-18C and Figure 19A-Figure 19C 17. The collar 1721 includes a base portion 1722 and a barb 1724 extending longitudinally (i.e., in the direction of insertion and withdrawal of the tube 102 into and out of the adapter 150) from the base portion 1722. The collar 1722 is attached (e.g., affixed) to the exterior of the collection / disposal tube 102 by an interference fit. The collar 1711 includes portions 1712, 1714 that are configured in a manner similar to the portions 512, 514 described above to form an interference fit with the open base end of the adapter 150 and prevent the collar 1711 from being further advanced into the adapter 150. The inner diameter of the collar 1711 provides an interference grip against the exterior 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. The collar 1711 includes a hole 1716 configured to receive the barb 1724. During shipment and storage, the tube 102 is held by the collar 1711 in a spaced relationship with the needle 158, while the collar 1721 is in a spaced relationship with the collar 1711. When the tube 102 is pushed or advanced into the adapter 105 and engaged with the needle 158, the collar 1721 is advanced toward the collar 1711 and the barbs 1724 lock into the holes 1716 in the flanged adapter collar 1711, which is an interference fit with the adapter base. The barbs 1724 of the collar 1722 lock into the openings 1716 of the flanged adapter collar 1711, forming a two-piece assembled collar. When the collection / disposal tube 102 is pushed out of the adapter 150, the tube 102 carries the two-piece assembled collar (including the collars 1711, 1721) away from the adapter 150.

[0130] Figures 18A-18C1811 is another securing mechanism configured as a two-piece assembly for holding the collection / disposal tube 102 in a spaced arrangement with the needle 158 in the adapter 150 during shipping, but allowing the collection / disposal tube 102 to be advanced into engagement with the needle 158 for sample collection. When the collection / disposal tube 102 is removed from the adapter 150, the two-piece assembly or securing mechanism is pulled from the adapter 150. The securing mechanism includes a snap ring 1811 having a ring portion 1814 and an upwardly facing extension or snap fin 1812 extending from the ring portion 1814 and biased to be angled toward the interior of the snap ring 1811. The snap ring 1811 fits into the open end base of the adapter 150. The adapter 150 includes a stepped end 1828 to receive the snap ring 1811. The securing mechanism also includes a sleeve 1821 and raised portions 1822 and 1823, the raised portions 1822 and 1823 being configured to retain an O-ring 1825 between portions 1822 and 1823. The sleeve 1821 also includes a raised portion or flange 1824. The sleeve 1821 fits over the collection and disposal tube 102 (e.g., the sleeve 1821 may be affixed to the exterior and / or tube 102 or by gripping the exterior of the tube 102 with a compression rib 1826). When the tube 102 is inserted into the adapter 150, the extension 1812 allows the raised portions 1822, 1823 and the O-ring 1825 to pass through the retaining ring 1811. The O-ring 1825 provides friction against the interior of the adapter 150 to maintain the tube 102 in a desired spaced relationship with 158 during shipping and / or storage. The extension 1812 of the snap ring 1811 signs against the outside of the sleeve 1821 and abuts the raised portion 1823, thereby not allowing the tube 102 to be pulled out of the adapter 150. The tube 102 is pushed into the adapter 150 to engage the desired 158 for sample collection. During this engagement, the extension 1812 allows the raised portion 1824 to pass through the snap ring 1811. When the tube 102 is pulled out of the adapter 150, the flange or raised portion 1824 on the sleeve 1821 catches on the end of the extension 1812 and pulls the snap ring 1821 therefrom as the collection / disposal tube 102 is removed from the adapter 150.

[0131] Figure 19A-Figure 19C yes Figures 18A-18C1914. An alternative aspect of the two-piece assembly in the adapter 150 is used to maintain the collection / disposal tube 102 in a spaced arrangement with the needle 158 in the adapter 150 during shipping, but allows the collection / disposal tube 102 to be advanced into engagement with the needle 158 for sample collection. When the collection / disposal tube 102 is removed from the adapter 150, the two-piece assembly or securing mechanism is pulled therefrom. The securing mechanism includes a snap ring 1911 and a sleeve 1921. The snap ring 1921 includes an upwardly facing extension or snap fin 1912 that extends against a ring portion or base 1914 and is biased to be angled toward the interior of the snap ring 1911. The snap ring forms an interference fit on the collection / disposal tube 102. The snap ring 1911 also includes a rib 1916 for gripping the interior of the adapter 150 and a flange 1915 formed in the base 1914 for abutting the edge of the open base end of the adapter 150. The snap ring 1911 fits into the base of the adapter 150 as shown, while the ribs 1916 grip the interior of the adapter 150 and the flanges 1915 prevent the snap ring 1911 from being pushed further into the adapter 150. In this aspect, the sleeve 1921 has first, second and third flanges or raised portions 1921, 1922, 1924 extending from the exterior of the sleeve 1921. The sleeve 1921 also includes ribs 1926 extending from the interior surface of the sleeve 1921 for gripping the exterior of the collection / disposal tube 102 when the sleeve 1921 is fitted thereon so that the sleeve 1921 and the tube 102 are immobile relative to each other. When the tube 102 is advanced into the adapter 150 for shipping, the fins 1912 allow the first raised portion 1922 to be advanced past the fins 1912 such that the end of the fins 1912 is inserted between the raised portions 1922 and 1923 to lock the tube 102 and the sleeve 1921 in place for shipping and storage, with the tube 102 in a spaced relationship with the needle 158. In this position, the inner surface of the fins 1912 rests on a portion of the second flange or raised portion 1923, thereby holding the collection / disposal tube 102 in place for shipping or storage. When the collection / disposal tube is in place in the second position, the angled flange 1923 is advanced past the retaining ring 1911. When the tube 102 is advanced into the adapter 150, the fins 1912 allow the second and third raised portions 1923 and 1924 to pass through the retaining ring 1911 such that the collection tube 102 engages the needle 158 for sample collection. As the tube 102 is pulled out of the adapter 150 , a third flange or raised portion 1924 on the sleeve 1921 snaps onto the end of the extension 1912 and pulls the retaining ring 1921 therefrom as the collection / disposal tube 102 is removed from the adapter 150 .

[0132] Fig. 201 is a collection / disposal tube 102 with a securing mechanism 2010, the securing mechanism 2010 comprising a flanged sleeve disposed about the tube 102 for holding the collection / disposal tube 102 in a spaced arrangement with the needle 158 in the adapter 150 during shipment, but allowing the collection / disposal tube 102 to be advanced into engagement with the needle 158 for sample collection. The securing mechanism 2010 comprises a sleeve 2016 coupled to and extending from a flanged portion comprising portions 2012, 2014. The portions 2012, 2014 may be configured with the same features as described above with respect to the portions 112, 114 of the securing mechanism 110 and the portions 512, 514 of the securing mechanism 510. In this manner, 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 engages with the adapter 150 by an interference fit. There is a gap between the outer diameter of the collection / disposal tube 102 and the inner diameter of the sleeve portion 2016, which allows the collection / disposal tube 102 to move easily (or freely) in the fixing mechanism 2010 and into the adapter 150 when a push / pull force is applied to the tube 102. The portion 2014 has a larger diameter than the proximal end of the adapter 150 and prevents the fixing mechanism 2010 from being advanced into the adapter 150 beyond the open end of the adapter 150 when the collection / disposal tube 102 is placed in the adapter 150. The flanged sleeve portion 2016 is flexible. When the collection / disposal tube 102 is advanced through the fixing mechanism 2010 and engages with the needle 158 in the adapter 150 for blood collection, the fixing mechanism 2010 remains in place. There is a radial gap between the tube and the sleeve 2016, allowing the tube to move freely in the sleeve 2016. When the collection / disposal tube 102 is advanced into engagement with the needle 158 in the adapter 150, the operator grips the collar adjacent the bottom of the adapter 150. Because the sleeve 2016 is flexible, as indicated by arrow 2018, the sleeve 2016 can assist in gripping (e.g., when gripped by the operator) the collection / disposal tube 102 when it is removed from the adapter 150. The portion 2016 is sized to have sufficient length so that when the tube 102 is advanced into the adapter 150 and engaged with the needle 150, the only way to grasp the tube 102 is by gripping the sleeve 2016 (as indicated by arrow 2018). This forces the user to pull the securing mechanism 2010 out with the tube 102. When the collection / disposal tube 102 is pulled from the adapter 150, the interference fit between the portion 2012 and the adapter 150 is overcome, and the flanged sleeve securing mechanism 2010 (being gripped by the user) is removed with the collection / disposal tube 102.

[0133] Fig.21 A securing mechanism 2110 is shown comprising a two-part collar, wherein the collar comprises portions 2112, 2114, the collar being, for example, similar to that described above with respect to Figure 5A-5D and Fig. 20 The collar 2114 fits into the bottom of the adapter 150 in the same manner as described above for the collar in the adapter 150, but is not advanced therein. The first portion 2112, 2114 of the collar in the base of the adapter 150 cooperates with the collar on the collection / disposal tube 102 to hold the collection / disposal tube 102 in a spaced relationship with the needle 158 in the adapter 102. The second portion 2116 of the collar on the collection / disposal tube 102 has an arm 2108 with a notched engagement member 2120 that will be advanced past the first portion 2114 of the collar when the collection / disposal tube 102 is advanced into the adapter 150. Thus, the second portion 2116 of the collar is made into an outer clamp. When the collection / disposal tube 102 is removed from the adapter 150 after sample collection, the engagement member 2120 on the second portion 2118 of the collar pulls the first portion 2114 of the collar from the base of the adapter 150.

[0134] Fig. 22 Another fixing mechanism 2210 is configured as a flanged sleeve for the collection / disposal tube 102. Fig. 20 The securing mechanism 2210 includes a flanged portion 2212 and a sleeve portion 2214. The flange 2212 locks to a flange at the base of the adapter 150 using a lip / ratchet 2218 that is similar to the one described above with respect to the Figure 14A-Figure 1 4D, the flanged portion 4112 including the catch 1418 fits onto the adapter base flange. Thus, the securing mechanism 2210 is secured by a locking fit with the adapter 150 rather than an interference fit. The inner diameter of the securing mechanism 2210 grips the outer diameter of the tube 102, and the collection / disposal tube 102 is held in a spaced arrangement with the needle 158 in the adapter 150 by the securing mechanism 2210 during shipment. The collection / disposal tube 102 is advanced through the securing mechanism 2210, advancing the collection / disposal tube 102 into connection with the adapter needle 158. After collecting the sample, the flexible flanged portion 2212 is separated from the flange at the base of the adapter 150, and the collection / disposal tube 102 with the sleeve 2210 attached is removed from the adapter 150. In one aspect, when locked to the base of the adapter 150, the flanged portion 2212 forms a sealed unit with the adapter 150 for enhanced sterilization. In one aspect, the sleeve portion includes one or more openings 2216 to enable an operator to view the contents of the tube 102 (eg, a collected sample).

[0135] Figure 23A-23C Another fixing mechanism 2310 is configured as a flanged sleeve. Fig. 20 and Fig. 22An alternative to the fixing mechanism shown. The fixing mechanism 2310 in this aspect includes portions, namely a flanged portion 2312 and a sleeve portion 2314. The flanged portion 2312 has ratchet teeth with a stop for locking to the base of the adapter 150, as described and shown above. The flanged sleeve 2310 is separated from the adapter 150 by squeezing the (elastomeric) sleeve 2314 and applying a pulling force away from the adapter 150, which causes the sleeve flange 2312 to separate from the flange at the base of the adapter 150 when the collection / disposal tube 102 is removed from the adapter 150. The sleeve 2314 provides a clamping surface for removing the collection / disposal tube 102. There is a radial gap between the sleeve 2314 and the collection / disposal tube 102. In one aspect, part or all of the sleeve portion 2314 can be made of a transparent elastomeric material so that the contents of the tube 102 can be seen through the sleeve portion 2314. In one aspect, the sleeve portion 2314 is secured during shipment by shrink wrap or band 2350 (e.g., Fig.23C 2314) is attached to the collection / disposal tube 102. The shrink wrap or band 2350 helps ensure that the collection / disposal tube 102 remains spaced apart from the needle 150 during shipping (in addition to the friction provided by the interior of the sleeve portion 2314).

[0136] Figure 24A-24B is another fixing mechanism 2410, also Fig. 20 and Figure 23A-23C Another aspect of the securing mechanism shown. The securing mechanism 2410 includes a flanged portion 2412 and a sleeve portion 2410 that include features similar to the flanged portions 2212, 2312 and sleeve portions 2214, 2314 described above. The sleeve portion 2414 includes (one or more) openings 2416 for enabling a user to observe the contents of the tube 102. Each of the (one or more) openings 2416 may be formed as a closed loop ( Fig.24A ) or slot ( Fig. 24B In one aspect, the securing mechanism 2410 can include friction beads 2420 on an inner circumference of the securing mechanism 2410 (eg, an inner circumference of the portion 2412 ) to add additional friction and help maintain the tube 102 in a stationary position relative to the securing mechanism 2410 . Fig.24A and Fig. 24B It is shown how the sleeve flange securing mechanism 2410 seats on the flange at the base of the adapter 150 to hold the collection / disposal tube 102 in a spaced position with the adapter needle 150 during shipping. As described above, the tube 102 can be moved relative to the securing mechanism 2410 and the adapter 150 when a push or pull force is applied to push in / pull out the adapter 150.

[0137] Fig.25A - FIG. 25C is another fixing mechanism 2510, also Fig. 20 , Figure 23A-23C and Figure 24A-24B Another aspect of the fixing mechanism shown is shown. Fixing mechanism 2510 includes the same features as fixing mechanism 2410 (i.e., a flange portion and a sleeve portion with (one or more) openings). In this aspect, as Fig.25B As shown, the securing mechanism 2510 may include a tape or adhesive strip 2550 (e.g., U-shaped, L-shaped, etc.) attached to a portion of the securing mechanism 2510 (e.g., attached to the sleeve portion) and a portion of the tube 102 to assist in maintaining the tube 102 in a stationary position relative to the securing 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 securing mechanism 2510. The securing mechanism 2510 maintains the tube 102 in a spaced relationship with the needle 158 during shipping, and allows the tube 102 to move relative to the securing mechanism and the adapter 150 when a push or pull force is applied to push in / pull out the adapter 150. It should be understood that after shipping and during use, the pulling and pushing forces on the tube 102 will decouple the strip 2550 from the tube 102.

[0138] Fig.26 A securing mechanism 2610 is shown, configured as a collar for a collection / disposal tube 102, the collar having a foldable section with a living hinge, the living hinge allowing the collar to hold the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping, but for blood collection, when the collection / disposal tube is advanced toward the needle, the living hinge folds, allowing the collection / disposal tube to be advanced into contact with the adapter needle for blood collection. After collection, when the collection / disposal tube is removed from the adapter, the collar is removed with the collection / disposal tube.

[0139] Figure 27A-27B 27 is another securing mechanism 2710 and another aspect of the collection / disposal tube assembly, wherein the collection / disposal tube has a sleeve attached thereto, the sleeve having a screw-on, screw-off flange attached to a flange at the base of the adapter. As shown, the tubing set is in fluid communication with the adapter, and blood is drawn into the collection / disposal tube when the needle in the adapter pierces the seal in the cap of the collection / disposal tube when the collection / disposal tube is advanced into contact with the needle. The collection / disposal tube is advanced in the sleeve, and the sleeve remains secured when locked onto the flange of the adapter. When the sleeve is screwed off the flange of the adapter, the collection / disposal tube is removed from the adapter.

[0140] Fig.282810 is another fixing mechanism, which is another aspect of the collection / disposal tube assembly, for keeping the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping, but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. In this aspect, the collection / disposal tube has a sleeve that can be threaded into the adapter. There is a flange at the base of the sleeve, as shown in the figure, the flange has a spiral ridge, and the spiral ridge provides a friction fit when it is advanced into the adapter. The flange limits the distance that the sleeve can be advanced. During shipping and storage, the sleeve keeps the collection / disposal tube in a spaced relationship with the needle. Twist the collection / disposal tube so that it is advanced within the sleeve. As shown in the figure, the tubing set is in fluid communication with the adapter, and when the needle in the adapter pierces the seal in the cap of the collection / disposal tube when the collection / disposal tube is advanced into contact with the needle, blood is drawn into the collection / disposal tube. After sample collection, the collection / disposal tube is removed from the adapter.

[0141] Figure 29A-29C Another securing mechanism 2910 is shown, which is another aspect of the collection / disposal tube assembly, for maintaining the collection / disposal tube 102 in a spaced relationship with the needle 158 in the adapter 150 during shipment, but allowing the collection / disposal tube 102 to be advanced into engagement with the needle 158 for sample collection. The securing 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 by the hinge 2918 to a tilted or angled position relative to the collar 2912. In one aspect, as Fig.29A As shown, the ring 2918 is biased to be inclined toward the interior of the collar 2912 and toward the interior of the adapter 150. In another embodiment, as shown in FIG. Fig.29C As shown, the ring 2918 is biased to be inclined toward the exterior of the collar 2912 and the exterior of the adapter 150.

[0142] The collar 2912 includes an outer diameter selected to fit within an inner circumference at the open end of the base of the adapter 150 with an interference fit (e.g., snugly). The securing mechanism 2910 includes one or more tabs 2916 extending away from the outer circumference of the collar 2912. The tabs 2916 are configured to abut the circumference defining the opening at the base end of the adapter 150 to prevent the securing mechanism 2910 from being further advanced into the interior of the adapter 150 and to maintain the securing mechanism 2910 in place at the base of the adapter 150. The flexible hinged spring ring 2912 is configured to receive the tube 102 and grip and hold the exterior of the collection / disposal tube 102 in a spaced relationship with the needle 158 during shipping and storage. When the ring 2914 is angled relative to the base of the adapter and / or the collar 2912, the inner circumference of the ring 2914 contacts the collection / disposal tube and grips or locks against the exterior of the tube 102. This gripping allows the tube 102 to move in and out of the adapter 150 relative to the securing mechanism 2910 and the adapter 150 when a pulling or pushing force is applied to the tube 102. The ring 2914 bends in the direction of the tube's movement. When the tube 102 moves the ring 2914 toward the adapter 150, the ring 2914 reduces or releases contact with the collection / disposal tube 102 and allows the collection / disposal tube 102 to be advanced. When the needle 158 in the adapter 150 pierces the seal in the cap of the collection / disposal tube 102 when the collection / disposal tube 102 is advanced into contact with the needle 158, blood is drawn into the collection / disposal tube 102. After the sample is collected, the collection / disposal tube 102 is removed from the adapter 150 along with the securing mechanism 2910. When the collection / disposal tube 102 is pulled away from the needle 158 in the adapter 150, the ring 2914 bends away from the retainer and more tightly grasps or clamps the collection / disposal tube 102. This locks the ring 2914 against the collection / disposal tube 102 , and when the collection / disposal tube 102 is removed from the adapter 150 , the collection / disposal tube 102 pulls on the securing mechanism 2910 .

[0143] Figure 30A-Figure 30CAnother securing mechanism 3010 and another aspect of a two-piece collar / sleeve assembly for maintaining a collection / disposal tube 102 in a spaced relationship with a needle 158 in an adapter 150 during shipping and storage but allowing the collection / disposal tube 102 to be advanced into engagement with the needle 158 for sample collection is shown. The securing mechanism 3010 includes a collar 3011 and a sleeve 3021. The collar 3011 includes portions 3012 and 3014 that are configured in the same manner as described above with respect to portions 512, 514, and portions to provide an interference fit with the open end at the base of the adapter 150 and prevent the collar 3011 from being advanced further into the adapter 150. The collar 3011 includes notched channels 3016 in the interior of the collar 3011. The collar 3011 also includes ratchet teeth or protrusions 3017 extending from the inner surface of each notched channel 3016. The sleeve 3021 has raised guides 3023 that travel through the notches 3016 in the adapter collar 3011. The raised guides 3023 each include a step or raised portion 3022. The sleeve 3021 includes a raised tab 3024 that extends toward the exterior of the sleeve 3021. The sleeve 3021 fits over the collection / disposal tube 102. In one aspect, the sleeve 3021 is mounted to the tube 102 via friction or grip between the interior of the sleeve 3021 and the exterior of the tube 102, or via an adhesive applied between the interior of the sleeve 3021 and the exterior of the tube 102. During shipping or storage, the raised portion 3022 seats behind the ratchet 3017 so that the collection / disposal tube 102 is held in a stationary position and in a spaced relationship with the needle 158 and requires additional pushing force to advance the tube 102 into the interior of the adapter 150. In one aspect, the raised portion 3022 has an interference fit with the inner surface of the recessed channel 3016, thereby also assisting in holding the tube 102 in a stationary position unless a pulling or pushing force is applied to the tube 102. When the needle in the adapter 150 is advanced into contact with the needle 158 in the collection / disposal tube 102, when the force on the tube 102 forces the raised portion 3022 to bypass the ratchet 3017, blood is drawn into the collection / disposal tube 102 when the seal in the cap of the collection / disposal tube 102 is pierced. The channel 3016 and the guide 3023 cooperate to provide 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 tabs 3024 are configured to flex inwardly in a direction toward the interior of the sleeve 3021 when compressed by contact with the edges and inner surfaces of the portions 3014 and 3012. As the tube 102 is pushed, the fins 3024 advance beyond the portion 3012 into the interior of the adapter 150, at which point the fins 3024 bend or deflect outward to their initial position due to the natural bias of the fins 3024. After the sample is collected, the collection / disposal tube 102 is pulled to remove the tube 102 from the adapter 150.When the tube 102 is pulled, the end of the wing 3024 abuts the edge of the open end of the portion 3012 that defines the collar 3011, thereby transferring the pulling force applied to the tube 102 to the collar 3011 and forcing the collar 3011 to disengage from the adapter 150, and the collar 3011 is removed together with the sleeve 3021 and the tube 102 when the collection / disposal tube 102 is removed from the adapter 150.

[0144] Figure 31A-Figure 31B A fixing mechanism 3110 is shown, which is also Figure 30A-Figure 30C Modifications to the fixing mechanism shown. It should be understood that Fig.31A Zhongyu Figure 30A-Figure 30C Components with similar component numbers (i.e., 30XX vs. 31XX) are configured with the same features unless otherwise noted. The collar 3111 has a clamp 3115 secured to a flange at the base of the adapter 150, as described in the previous embodiments above. The inner surface of the collar 3111 includes an inclined surface or raised portion 3019 that converges toward the center of the collar 3111. The clamp 3115 and the raised portion 3019 are configured as deflectable flaps, wherein deflection of a first flap 3119 in an arc toward the exterior of the collar 3111 causes the first clamp 3115 to deflect in an arcuate motion toward the interior of the collar 3111. The same relationship applies to the second flap 3119 and the second clamp 3115, etc. The arcuate motion is caused by Figure 31A-Figure 31B 1. As described above, the sleeve 3021 has a raised guide 3121 that travels through a notch 3116 in the adapter collar 3111 and a ratchet 3117 that cooperates with a raised portion 3122. The sleeve 3011 also includes a raised portion 3125 that corresponds to each pair of clamps 3115 and tabs 3119, which contact the tabs 3119 to cause deflection of the clamps 3115 as described below. The sleeve 3121 fits over the collection / disposal tube 102. The sleeve has a raised portion 3112 at the base of the sleeve 3112 that interacts with the ratchet 3117 to ensure that the collection / disposal tube 102 remains in a spaced relationship with the needle 158 during shipping and storage. When the needle 158 in the adapter 150 pierces the seal in the cap of the collection / disposal tube 102 as the collection / disposal tube 102 is advanced into contact with the needle 102 by bypassing the ratchet 3017, blood is drawn into the collection / disposal tube 102. When the tube 102 is advanced into the adapter 150 and engages the needle 158, the raised portion 3125 deflects the raised portion 3119, which causes the clamp 3115 to deflect, as shown in FIG. Figure 31A-Figure 31B100. As shown by the dashed lines and arrows in FIG. 101. When the clamp 3115 is deflected in this manner, the clamp 3115 disengages from the flange of the base of the adapter 150. When the raised portion 3125 deflects the raised portion 3119, the portions 3125 and 3119 can form an interference fit so that after sample collection, when the collection / discarding tube 102 is pulled and removed from the adapter 150, the collar 3111 and sleeve 2131 of the clamp 3115 are also removed from the adapter 150 along with the tube 102. The disengaged clamp 3115 allows for withdrawal.

[0145] Figure 32A-32B150 during shipment but allows the collection / disposal tube 102 to be advanced into engagement with the needle 158 for sample collection. In this aspect, the securing mechanism 3210 includes a ring or collar 3212 and a slot 3214 on the adapter 150. The collar 3212 is disposed on the collection / disposal tube 102 and has posts 3212, each of which engages a slot 3214 in the adapter housing 150. It should be understood that although multiple slots and posts are shown, in some aspects, a single slot and post may be used. The side slot 3214 includes portions 3215 and 3216. The portion 3215 extends in a longitudinal direction parallel to the direction in which the tube 102 is inserted into and removed from the adapter 150. The portion 3216 branches out from the portion 3215 in a direction transverse to the longitudinal direction. The portion 3215 of the slot 3214 is configured to receive the post 3213 and allow the collar and tube 102 to be advanced longitudinally within the portion 3215 of the slot 3214. The portion 3216 receives the post 3213 to allow the collar 3212 (and tube 102) to be rotated into a locked position (i.e., to prevent longitudinal movement of the collar 3212 and tube 102), which locks the collection / disposal tube 102 in a spaced relationship with the needle 158 during shipping and storage. In one aspect, the portion 3216 of the slot 3214 includes a ratchet or protrusion 3217 extending into the portion 3216 to lock the post 3213 in the portion 3215. The slot 3219 behind the ratchet 3217 allows the ratchet 3217 to move longitudinally when the post 3213 is formed to traverse (e.g., by a torque applied to the tube 102 by a user) the portion 3216 of the slot 3214. To advance the collection / disposal tube 102 into engagement with the adapter needle 158, the collection / disposal tube 102 is rotated / twisted so that the post 3213 travels through the portion 3215 and into the portion 3215 of the slot 3214, and then the tube 102 is pushed longitudinally to allow the post 3213 to travel longitudinally through the portion 3215 until the tube 102 is advanced into engagement with the needle 158 in the adapter 150 for blood collection, as the collar pin / post 3213 can be advanced again along the slot portion 3215 in the adapter housing 150. After sample collection, the collection / disposal tube 102 is removed from the adapter 150 by pulling on it, thereby pulling the post 3213 through the slot portion 3215, along with the collar 3212, until the tube 102 and collar 3212 are removed from the adapter 150. It should be appreciated that the collar 3212 may be fixedly coupled to the tube 102 or may be interference fit or friction fit with the tube 102 such that the collar 3212 and the tube 102 remain stationary relative to each other.

[0146] Figure 33A-Figure 33B yes Figure 32A-32B modifications in terms of. Figure 33A-Figure 33BThe securing mechanism in the adapter 150 includes a collar 3312 and a slot 3314 in the adapter 150. The collar 3312 includes a post 3313 slidable in the slot 3314, which includes slot portions 3316, 3315. The slot portion 3315 extends longitudinally, while the slot portion 3316 branches out in a direction transverse to the longitudinal direction. The collar 3312 disposed on the collection / disposal tube 102 has a post 3313 that engages an angled slot 3316 in the adapter housing 150. The side slot 3316 receives the follower pin / post 3313 on the collar 3312 and holds the collection / disposal tube 102 in a spaced relationship with the needle 158 in the adapter 150. The slot portion 3316 is angled so that the post 3313 prevents the tube 102 from being pulled out of the adapter 150 when seated at the closed end of the portion 3316. At the same time, the slot portion 3316 is angled relative to the portion 3315 so that when the operator longitudinally advances the collection / discarding tube 102, the follower pin / post 3313 is allowed to move through and past the ratchet into the slot portion 3315, which causes the collection / discarding tube 102 to twist 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 longitudinally advanced into the adapter 150 and engage the needle 158. After sample collection, the collection / discarding tube 102 is removed from the adapter 150 by pulling on the tube 102. The tube 102 is removed along with the collar 3312. The follower pin / post 3313 moves along the vertical main slot 3315 to remove the collection / discarding tube 102 from the collection / discarding device 150.

[0147] Figure 34A-Figure 34B yes Figure 32A-32B Modifications in various aspects. Figure 34A-Figure 34BThe fixing mechanism 3410 in the adapter housing 150 includes a collar 3412 with a post 3413 and a slot 3414 in the adapter housing 150. The slot 3414 is configured as a "U-turn" shaped path and forces the user to collect the sample in the tube 102 before removing the collection / disposal tube 102 from the adapter 150. The slot may include a ratchet or protrusion 3417. The configuration described herein that requires the collection / disposal tube 102 to engage the needle 158 in the adapter 150 before removing the collection / disposal tube 102 from the adapter 150 is referred to herein as a forced compliance configuration. The collar 3412 disposed on the collection / disposal tube 102 has a driven post 3413 that engages the slot 3414 in the adapter housing 150. The side slot allows the collar 3414 to be rotated into a locked position, which locks the collection / disposal tube 102 in a spaced relationship with the needle during shipping and storage. The ratchet or protrusion 3417 can hold the post 3413 in the locked position. To advance the collection / disposal tube 102 into engagement with the adapter needle 158, the collection / disposal tube 102 is rotated so that the post 3413 is also rotated past the ratchet 3417 and the collar / collection / disposal tube assembly can be advanced longitudinally (i.e., while the post 3413 travels along the first longitudinal portion 3419 of the slot 3414 to the end of the portion 3419) into engagement with the needle 158 in the adapter 150 for blood collection, as the collar follower pin 3413 can be advanced again along the slot 3419 adjacent to the side slot in the adapter housing 150. After sample collection, the collection / disposal tube 102 is rotated again and the collar pin 3413 travels downward along the discard slot longitudinal portion 3421, thereby removing the collection / disposal tube 102 from the adapter 150 together with the collar 3412. To follow this path, the collection / disposal tube 102 must be engaged with the needle 158 in the adapter 150.

[0148] Figure 35A-Figure 35B yes Fig.33A - Modification of aspects of Figure 32b. Figure 35A-Figure 35B The fixing mechanism 3510 in the embodiment 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 abut the flange base of the adapter 150 to prevent 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, while post 3518 extends toward the exterior of portion 3511. Posts 3516, 3518 are configured to be able to bend radially inwardly toward the center of the collar 3511. As will be described below, post 3516 controls the movement of the collection / disposal tube 102 relative to the adapter 150.

[0149] The sleeve 3521 includes a ribbed interior (e.g., includes ribs 3521 extending from an inner surface of the sleeve 3521 for gripping the tube 102). The ribbed sleeve 3521 fits snugly over the collection / disposal tube 102. When the portion 3512 is inserted into the adapter 150 and the portion 3514 abuts the adapter 150, the locking ratchet pin 3518 locks into and extends into the slot 3522 in the adapter 150 to hold the collar 3511 in a stationary position relative to the adapter 150. The sleeve 3521 includes a relief or slot 3527 in the outer surface of the sleeve 3521. The sleeve 3521 also 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 / disposal tube 102 is rotated so that the post 3516 is engaged in the end of the angled slot 3525, this locks the collection / disposal tube 102 in a spaced relationship with the needle 158 during shipping and storage and prevents (i.e., by the closed end of the pin 3516 abutting the portion 3525) the tube 102 or the collar 3511 from being further advanced into the adapter 150. Fig.35B As shown, in this position, the relief slot 3527 on the exterior of the sleeve 3521 is not aligned with the post 3518, so the securing mechanism cannot escape the adapter 150. To advance the collection / disposal tube 102 into engagement with the adapter needle 158, the collection / disposal tube 102 is pushed and rotated and guided by the travel of the pin 3516 in the portion 3525 of the slot 3520 and into the portion 3523 so that the collar / collection / disposal tube assembly can be advanced into engagement with the needle 158 in the adapter 150 for blood collection, as the collar pin 3516 can be advanced again along the portion 3523 of the slot 3520 in the sleeve 3521. After sample collection, the collection / disposal tube 102 is pulled and guided by the pin 3516 in the sleeve 3520 and the sleeve 3521 travels downwardly, as the collar pin 3516 is aligned with the slot 3520 in the sleeve 3521. When the collection and disposal tube 102 is removed from the adapter 150, the pin 3516 engages the closed end of the portion 3523 of the slot 3520 (a hard stop) and the relief slot 3527 aligns with the pin 3518, allowing the pin 3518 to flex radially inward and out of the slot 3522 in the adapter 150. Thus, when the pin 3516 engages the hard stop at the closed end of the portion 3523 of the slot 3520, the collar 3511 is not locked with the adapter 150, but is pulled out of the adapter 150 along with the tube 102.

[0150] Figure 36A-36B150 and the like. The embodiment of the present invention is another aspect of the assembly with a securing mechanism that maintains the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. In this aspect, the securing mechanism includes a collar 3612 and an insert 3614. The collar 3612 is disposed around the tube 102 and includes a flexible finger or post 3616 extending toward the exterior of the tube 102. The insert 3614 includes a cylindrical or tubular portion 3620 received in the interior of the adapter 150. The insert 3614 also includes a flanged end 3618 having a diameter greater than the inner diameter of the adapter 150, thereby preventing the insert 3618 from being advanced further into the adapter 150. The insert 3614 also 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 toward the interior 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 shipped or stored, the tube 102 and the collar 3612 are held in a spaced relationship with the needle 158. In one aspect, the finger 3616 presses into the inner surface of the insert 3614 so that the tube 102 is held in a spaced relationship unless force is applied. In one aspect, the insert 3614 includes a longitudinal groove 3613 in which the post 3616 travels or slides when the tube 102 is pushed into the adapter 150. The collection / disposal tube 102 can be advanced into engagement with the needle 158 in the adapter 150. As the tube 102 is pressed into the adapter 150, the fingers 3616 enter the slots 3622 and force the tabs 3624 out of the slots 3622 to release the insert 3614 from the locked arrangement with the adapter 150. After sample collection, the collection / discarding tube 102 is pulled and removed from the adapter 150, and the fingers 3616 in the slots 3622 pull the insert 3614 out of the adapter 150 along with the tube 102 and the collar 3612.

[0151] Figure 37A-Figure 37B yes Figures 36A-36BAnother aspect of the assembly shown includes a securing mechanism that holds the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. In the illustrated aspect, the securing mechanism has a sleeve 3714 having a bump 3717, a slot 3715, and a slot 3716. The securing mechanism also includes a collar 3731 that includes a raised portion 3732 and a flexible extension or fin 3734 that is biased to extend at an angle toward the exterior of the collar 3731. As shown, the collar 3731 includes ribs 3733 to grip the exterior of the tube 102. The sleeve 3714 is received in the adapter 150 as shown and includes a flanged end to prevent the sleeve 3731 from being advanced further into the adapter 150 than shown. The adapter includes a flexible extension or fin 3724 that is biased to extend toward the interior of the adapter 150. When the sleeve 3714 is inserted into the adapter 150, the extension 3724 extends into and captures the end of the corresponding slot 3716 to hold the sleeve 3714 in the adapter 150 in a locked position. The collar 3731 holds the tube 102 as shown, and the tube 102 is inserted into the sleeve 3714 so that the extension 3734 extends into and captures the slot 3717 to hold the tube 102 and the collar 3731 in a locked position so that the tube 102 is in a spaced relationship with the needle 158 of the adapter 150. When the tube 102 is advanced into the adapter 150, the raised portion 3716 is guided along the slot 3716 and the extension 3734 is deflected inwardly to release the collar 3731 from the locked position. In this way, the collection / disposal tube 102 can be advanced into engagement with the needle 158 in the adapter 150. When the tube 102 engages the needle 158, the raised portion 3732 presses the extension 3724 out of the slot 3716, thereby unlocking the sleeve 3714 from the adapter 150. In addition, the extension 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 along with the now engaged sleeve 3714 and collar 3731.

[0152] Fig.38 yes Figure 37A-Figure 37B An aspect of the invention is to utilize a strap or fastener 3850 to lock the collection / disposal tube in place away from the needle in the adapter during shipping and storage rather than relying on a protrusion.

[0153] Figure 39A-Figure 39B yes Figures 36A-36BAnother aspect of the assembly shown includes a securing mechanism that maintains the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. In the illustrated aspect, the adapter has a sleeve with a resilient stop that will allow a protrusion on the collar that is press-fit onto the collection / disposal tube to pass through it when a force is applied to advance the collection / disposal tube in the adapter. Thus, the application of the band is to ensure that the collection / disposal tube maintains the desired spaced relationship with the adapter needle. When the band is removed, the collection / disposal tube can be advanced into engagement with the needle in the adapter. The collar also has a ratchet protrusion that travels along a guide in the adapter sleeve. At this point, the protrusion on the collar and the resilient stop engage the protrusion on the collar. After sample collection, the collection / disposal tube is removed from the adapter along with the adapter sleeve engaged with the collar.

[0154] Figure 40A-40B Another aspect of the assembly with a securing mechanism that holds the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. In the illustrated aspect, the adapter has a longitudinal sliding groove 4022 and a locking groove or slot 4020 disposed in the inner surface of the adapter 150. In addition, the securing mechanism also includes a collar 4011 secured or coupled to the exterior of the tube 102. The collar 4011 includes flexible fingers or extensions 4012 extending from a ring portion of the collar 4012. The flexible fingers 4012 on the collar 4012 extend into corresponding locking grooves 4020, when the tube 102 is in a spaced relationship with the needle 158 (i.e., not engaged therewith) for storage and / or shipping, and the grooves 4020 and flexible fingers 4012 prevent the tube 102 from being inserted into / removed from the adapter 150. The flexible fingers 4012 are configured to press down when the collar 4012 and the tube 102 are rotated. Thus, the fingers 4012 allow the tube 102 to rotate so that the rotation of the tube 102 causes the fingers 4012 to exit the locking groove 4020 and enter the sliding groove 4022. When the collection / disposal tube 102 is rotated to place the fingers 4012 in the sliding groove 4020 of the adapter 150, the collection / disposal tube 102 can be advanced into engagement with the needle 158 in the adapter 150 while the fingers 4012 slide longitudinally in the sliding groove 4022 to allow advancement. After sample collection, the collection / disposal tube 102 is removed from the adapter 150 by sliding it out with the flexible fingers 4012 sliding along the sliding groove 4022.

[0155] Fig.41Another aspect of the assembly with a securing mechanism that holds the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. In this aspect, the securing mechanism is configured so that the collection / disposal tube 102 must be placed into engagement with the needle 158 in the adapter 150 before it is removed from the adapter 150. Thus, this aspect is also a forced compliance configuration. In the illustrated aspect, the collection / disposal tube 102 has a sleeve 4111 attached thereto, with a portion 4112 of the sleeve 4111 having an enlarged diameter relative to a portion 4113. The sleeve 4111 has a flange at the proximal end that prevents the sleeve from being fully advanced into the adapter 150. The adapter 150 has a window 4122 cut into the side of the housing that holds a molded flexible member 4124 (e.g., a free-floating oval locking ring) in an oval configuration. When in the resting state, the member 4124 is oval in shape. The oval member 4124 holds the collection / disposal tube 102 in a spaced relationship with the adapter needle 158. In this regard, on the one hand, the ring 4124 grips the outer surface of the sleeve 4111 at the portion 4113 along the inner circumference of the minor axis (i.e., the apex of the minor axis) to hold (via friction) the tube 102 in the spaced relationship. The larger diameter portion of the oval member 4124 extends into / out of the window 4122 in the base of the adapter 150 and this oval member 4124 locks the collection / disposal tube 102 in place so that it is maintained in a spaced relationship with the needle 158 during shipping and storage. When the collection / disposal tube 102 is forced past the oval member 4124, the tube 102 can be advanced into contact with the adapter needle 158 for sample collection. In this position, the wider portion 4112 of the sleeve 4111 changes the configuration of the elliptical component 4124 into a circle (i.e., the outer surface of the portion 4112 contacts and pushes against the inner circumference of the minor axis or minor diameter of the elliptical component 4124 to change the shape into a circle), which pulls those portions of the elliptical component 4124 that extend beyond the window 4122 at the base of the adapter 150 to the inside of the adapter 150. In this position, the component 4124 is held snugly by friction against the outer diameter of the portion 4112. This change in shape allows the collection / disposal container 102 to be withdrawn from the adapter 150, thereby taking the component 4112 with the tube 102 and the sleeve 4111 away.

[0156] Figure 42A-42B yes Fig.41Another aspect of the assembly of the invention includes a securing mechanism that holds the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. In this aspect, the collection / disposal tube 102 must be placed into engagement with the needle 158 in the adapter 150 before it is removed from the adapter 150. Thus, this aspect is also a forced compliance configuration. In the illustrated aspect, the collection / disposal tube 102 has a sleeve 4211 attached thereto, wherein a portion 4212 of the sleeve 4211 has an enlarged diameter relative to a portion 4213. The adapter 150 has a window 4222 above a flange at its base that holds a flexible oval ring 4224. The oval ring 4224 includes a fin or extension 4226 located at the vertex of the major axis (largest diameter) of the oval ring 4224. The fin or extension 4226 is shaped to be received in the window 4222. The larger diameter portion of the elliptical member 4224 (i.e., the fin 4226) protrudes from the window 4222 in the base of the adapter 150 and the ring 4224 extends along the inner circumferential portion of the minor axis (i.e., the apex of the minor axis) into the window 4215 of the sleeve 4211. In this way, the elliptical member 4224 locks the collection / disposal tube 102 in place so that it is maintained in a spaced relationship with the needle 158 during shipping and storage. The elliptical ring 4224 holds the collection / disposal tube 102 (by engaging the windows 4222 and 4215) in a spaced relationship with the needle 158 in the adapter 150. When the collection / disposal tube 102 is forced through the elliptical ring 4224 and into the interior of the adapter 150, the tube 102 can be advanced into contact with the adapter needle 158 for sample collection. In this position, the tube 102 is locked in place in the same manner as described above with respect to the adapter needle 158. Fig.41 In the same manner as described above, the wider portion 4212 of the sleeve 4211 changes the oval ring 4224 configuration to a circular shape, which pulls the tabs 4226 extending into the window 4222 at the base of the adapter 150 into the inside of the adapter 150 and pulls the portion of the inner circumference of the ring 4224 extending into the window 4215 out of the window 4215. This change in shape allows the collection / disposal container 102 to be withdrawn from the adapter 150, thereby taking the ring member 4224 and the sleeve 4211 with it.

[0157] Figure 43A-43BAnother aspect of the assembly is a securing mechanism that holds the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In the illustrated aspect, the adapter has a threaded inner collar with a flange that abuts a flange at the base of the adapter. The collection / discarding tube has a ring with a post. When the collection / discarding tube is placed in the adapter, the collection / discarding tube is held away from the adapter needle. When sample collection is desired, the collection / discarding tube is rotated, which advances the ring, threading it so that the ring post falls into the ratchet teeth in the threaded inner collar. When engaged, the sample is collected. After sample collection, the sample collection / discarding tube ring is pulled out of the adapter together with the threaded inner collar.

[0158] Figures 44A-44B yes Figure 43A-43B 150 and 150. The alternative aspect of the assembly with a securing mechanism that holds the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. In the illustrated aspect, the securing mechanism includes a slotted inner collar 4111 having a flanged end that abuts the base of the adapter 150 and prevents the collar 4111 from being further inserted 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 ratchet teeth 4415, 4415. The collection / disposal tube has a ring 4431 attached thereto, the ring 4431 having a post 4433 extending from the base of the ring. When the collection / disposal tube 102 is placed in the adapter 150, the collection / disposal tube 102 is held away from the adapter needle 158 by the engagement of each post 4433 with each first ratchet 4414. When sample collection is required, the collection / disposal tube 102 is pushed into the adapter 150 so that the ring post 4433 falls into the locking ratchet 4415 at the top of the slot 4413. When engaged, the sample is collected into the collection / disposal tube 102. After sample collection, the sample collection / disposal tube 102 ring 4431 is pulled out of the adapter 150 together with the slotted inner collar 4411.

[0159] Figure 45A-Figure 45BAnother aspect of the assembly with a securing mechanism that holds the collection / disposal tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / disposal tube to be advanced into engagement with the needle in the adapter for sample collection. The adapter has two retaining holes in its housing, near a flange at the bottom of the adapter. An inner sleeve is provided on the collection / disposal tube. A collar is provided on the sleeve. The collar has a first larger diameter, a second smaller diameter, and a flange distal to the cap of the collection / disposal tube. A finger-like member is provided in the sleeve that extends outwardly and when aligned with the retaining hole in the collar, the finger-like member will fit into the retaining hole in the collar and hold the collection / disposal tube away from the needle in the adapter for storage and processing. Retracting the collar will release the finger-like member from the hole. The collection / disposal tube can then be advanced upward for sample collection or downward to remove the collection / disposal tube from the adapter. After sample collection, the sample collection / disposal tube is pulled from the adapter together with the sleeve and the finger-like member attached thereto.

[0160] Figure 46A-46B Another aspect of the assembly with a securing mechanism that holds the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. The adapter has two retaining holes in its housing, near the flange at the bottom of the adapter. The collection / discarding tube has a flanged collar thereon and a seat with fingers extending upward and outward from the seat into the adapter. As the collar and collection / discarding tube are advanced into the adapter, the holes in the collar align with the holes in the adapter and the fingers extending from the seat on the collection / discarding tube lock the collection / discarding tube in a position away from the needle in the adapter for storage and processing. Retracting the collar releases the fingers from the holes in the adapter housing. The collection / discarding tube is then advanced upward for sample collection. After sample collection, the sample collection / discarding tube is pulled from the adapter together with the seat and the fingers attached thereto.

[0161] Figure 47A-47B A diversion adapter is shown that provides a first flow path for collecting a first portion of a collected sample and a second flow path for collecting a portion of the sample to be tested. The adapter has an inner sleeve that is retracted into the adapter when shipped. The inner sleeve is pulled back and the post in the inner sleeve locks into a ratchet in the adapter housing, and the diversion portion of the sample is drawn through the first flow path in the adapter into the upper chamber of the adapter. After the diversion sample is collected, the inner sleeve is pushed upward and the adapter engages a sample collection bottle, and the sample travels through the second flow path into the sample collection bottle.

[0162] Figure 48A-Figure 48BAnother aspect of the assembly with a securing mechanism is shown, which retains the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, the collection / discarding tube is delivered into the adapter within a sleeve having a flange on the end of the sleeve away from the adapter needle. In a first position, when the collection / discarding tube is held away from the adapter needle for shipping and storage, the band secures the sleeve in a position where the sleeve flange is spaced from the adapter flange at the adapter opening. When the securing material is peeled off, the collection / discarding tube and sleeve are further advanced into the adapter for sample collection. After sample collection, the sample collection / discarding tube is pulled from the adapter together with the sleeve.

[0163] Figure 49A-49F Different fastener configurations and placements are shown that maintain the collection / disposal tube 102 and the adapter needle 158 in a spaced relationship during shipping and storage and that will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection after the fastener 4960 is removed. As shown, one or more stickers 4960 may be disposed on the base end of the adapter 150 and on a portion of the exterior of the tube 102. The fastener placement and configuration are selected so that the tube 102 cannot be inadvertently pulled from or pushed into the adapter 150. Prior to use, the fastener 4960 holds the tube 102 in place. In addition, the fastener placement and configuration is such that when the tube 102 is pushed into the adapter 150, the portion of the fastener 4960 that is attached to the exterior of the tube 102 is peeled off, or torn or otherwise decoupled from the tube 102 (e.g., Fig.49E 150) to allow the collection / discarding tube to be advanced to the second position. On the one hand, as the tube 102 is pushed into the adapter 150, the perforations 4962 (or thinned sections 4964) in the fixation are configured to tear to cut the fixation 4960 and allow the tube 102 to be pushed into engagement with the needle 158. As shown, the fixation 4960 can be in various shapes (e.g., capital letter I-shaped, rectangular, U-shaped, Y-shaped, etc.). The fixation may include perforations 4962 or thinned sections 4964 to help the fixation continue to tear. The fixation 4960 may be configured with suitable properties, such as fixation size, orientation, (one or more) perforations 4962 (number of perforations, perforation locations, perforation depths, etc.), so that (one or more) fixation 4960 maintain a spaced relationship and peel off from the tube 102 when the tube 102 is pushed into the adapter 150 to engage with the needle 158. In one aspect, a retainer is included on either side of the tube 102 and the adapter 150 , maintaining the tube 102 aligned within the adapter 105 with the needle 150 engaged with the tube 102 during insertion of the tube 102 into the adapter 150 .

[0164] Fig.50Different fixture configurations and placements are shown that maintain the collection / disposal tube 102 and adapter needle 158 in a spaced relationship during shipping and storage and that will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection after removal of the fixture(s) 4960. In this aspect, the securing mechanism of the collection / disposal tube 102 has a collar 5011 thereon (e.g., including the same features as the collar 510 and other similar collars described above) and the fixture(s) 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 cutting edge(s) 5012 configured to cut or sever the fixture(s) 4960 (e.g., at a center, perforation, or thinner section thereof) into two separate pieces. With the fixture(s) 4960 severed, the collar 5011 can be advanced into the adapter 150 for sample collection. After sample collection, the collection / disposal tube 102 together with the collar 5011 is removed from the adapter 150.

[0165] Fig.51 The use of a heat shrink material or wrap 5170 is shown to maintain the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and, after removal of the heat shrink material 5170, will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. To advance the collection / disposal tube 102 into the adapter 150, the heat shrink material 5170 is removed. The shrink wrap 5170 may include perforations (as described below with respect to the wrap 5770) to facilitate easy tearing / breaking of the wrap 5170 and removal of the wrap 5170, thereby allowing the tube 102 to be inserted into the adapter 150. The wrap 5170 has the advantage of conforming to different geometries of the adapter 150, tube 102, securing mechanisms, etc. that may be present in the assembly. After collection, the collection / disposal tube 102 is removed from the adapter 150.

[0166] Fig.52 Another aspect of an assembly with a securing mechanism is shown that maintains the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, the collection / discarding tube is delivered into the adapter within a sleeve having a bellows at its end. The bellows operate to maintain the collection / discarding tube spaced from the adapter needle during shipping and storage. When sample collection is initiated, the collection / discarding tube is forced upward, thereby crimping the bellows and allowing the adapter needle to be inserted into the collection / discarding tube for sample collection. When the desired amount of sample is collected, the collection / discarding tube and sleeve are removed from the adapter.

[0167] Fig.53 Another aspect of an assembly with a securing mechanism is shown that maintains the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, the collection / discarding tube is delivered into the adapter in a sleeve having a crimped corrugated portion. The crimped corrugated portion operates to maintain the collection / discarding tube spaced from the adapter needle during shipping and storage. When sample collection begins, the corrugated portion expands and the collection / discarding tube is forced upward, allowing the adapter needle to be inserted into the collection / discarding tube for sample collection. When the desired amount of sample is collected, the collection / discarding tube and sleeve are removed from the adapter.

[0168] Fig.54 yes Fig.52 Another aspect of the components described in . Fig.54 An assembly is shown with a securing mechanism that maintains the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, the collection / discarding tube is disposed in a sleeve having a bellows at its distal end adjacent to a flange that does not allow the bellows to enter the adapter. The bellows operate to maintain the collection / discarding tube spaced from the adapter needle during shipping and storage. When sample collection is initiated, the collection / discarding tube is forced upward, thereby causing the bellows to collapse and allowing the adapter needle to be inserted into the collection / discarding tube for sample collection. When the desired amount of sample is collected, the collection / discarding tube is removed from the adapter. The sleeve, which has never entered the adapter, remains on the collection / discarding tube.

[0169] Figure 55A-Figure 55B Another aspect of the assembly is a securing mechanism that maintains the collection / discarding tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discarding tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, the collection / discarding tube is placed in a sleeve with a netting disposed on the exterior of the collection / discarding tube. The folding operation in the netting is to maintain the collection / discarding tube spaced from the adapter needle during shipping and storage. When sample collection begins, the collection / discarding tube is forced upward, allowing the folding to unfold, thereby allowing the collection / discarding tube to engage the adapter needle, whereby the needle is inserted into the collection / discarding tube for sample collection. When the desired amount of sample is collected, the collection / discarding tube is removed from the adapter together with the netting.

[0170] FIG. 56 is another aspect of an assembly with a securing mechanism that maintains the collection / discard tube in a spaced relationship with the adapter needle during shipping and storage and will allow the collection / discard tube to be advanced into engagement with the needle in the adapter for sample collection. In this aspect, a stopper is positioned on top of the cap of the collection / discard tube. When the stopper / collection / discard tube assembly is positioned within the adapter, the stopper has a perimeter that forms a friction fit with the adapter. The friction fit allows the stopper to maintain the collection / discard tube in a spaced relationship with the adapter needle.

[0171] Fig.57 Another aspect of the assembly is a clamp-like or shrink wrap securing mechanism that holds the collection / disposal tube 102 in a spaced relationship with the adapter needle 158 during shipping and storage and will allow the collection / disposal tube 102 to be advanced into engagement with the needle 158 in the adapter 150 for sample collection. In this aspect, a removable clamp 5750, a tear-away strip or fastener 5760, or a shrink wrap 5770 (disposed on the base end of the adapter 150 and on the tube 102 and at least a portion of the sleeve 5721) is used to force the spaced relationship between the sleeve 5721 (configured with the same features as the sleeve 5821 described below) in which the collection / disposal tube 102 is disposed and the adapter 150. The shrink wrap 5770 may include a tear handle 5772 and perforations (indicated by dashed lines) for tearing the shrink wrap 5770 from the assembly. It should be understood that the assembly may include any of the securing mechanisms described herein, and that a clamp, a fastener, or a shrink wrap may be used in addition to or in lieu of a securing mechanism to maintain the spaced relationship. The spaced relationship ensures that the collection / disposal tube 102 does not engage the adapter needle 158 during storage and shipment. When sample collection is to begin, the clamp 5750 or fastener 5760 is removed and the sleeve in which the collection / disposal tube is disposed can be advanced into contact with the adapter needle 158 for sample collection. After sample collection, the collection / disposal tube 102 (still disposed in the sleeve) is removed from the adapter.

[0172] Figure 58A-Figure 58C yes Figure 17A-17B , Figures 18A-18C and Figure 19A-Figure 19CAn alternative aspect of the invention. Shown is a securing mechanism comprising a three-piece assembly for holding a collection / disposal tube 102 in a spaced relationship with a needle 158 in an adapter 150 during shipping but allowing the collection / disposal tube 102 to be advanced into engagement with the needle 158 for sample collection. When the collection / disposal tube 102 is removed from the adapter 150, the three-piece assembly is pulled therefrom. The securing mechanism comprises a snap ring 5811, a sleeve 5821, and a ring 5831. The snap ring 5821 comprises an upwardly facing extension 5812 extending against a ring base 5814 and biased to be angled toward the interior of the snap ring 5811. The outer diameter of the ring base 5814 is adapted to be snugly retained in the base open end of the adapter 150. In this aspect, the sleeve 5821 is configured as a tube having an open end for receiving a portion of the tube 102 and a closed end 5825. In one aspect, sleeve 5821 is secured (e.g., by an adhesive) to tube 102. Sleeve 5821 includes first and second flanges or raised portions 5822 and 5824. Collar or ring 5831 is placed adjacent to cap 5831 on collection and disposal tube 102. Collar 5831 is sized to be pushed through and over snap ring 5811 and allowed to pass through extension 5812. The outer diameter of collar 5831 can be configured to grip the interior of adapter 150 to hold collection / disposal tube 102 in a spaced relationship with adapter needle 158 during shipping and storage. Additionally and / or alternatively, extension 5812 can grip the exterior of tube 102 to hold tube 102. In one aspect, adapter 150 includes a stepped end in the base to receive snap ring 5811. The collar 5831 abuts the end of the extension 5812 and thus prevents the tube 102 from being easily pulled out of the adapter 150 and is held in a spaced relationship with the needle 158. The tube 102 can be pushed further into the adapter 150, wherein the extension 5812 allows the raised portion 5822 to pass through the collar 5811 and the extension snaps onto the exterior of the sleeve 5821 to the area between the raised portions 5822 and 5824. In this position, the collar 5811 and the sleeve 5831 are locked to each other and the extension 5812 prevents the tube 102 from being easily pulled out of the adapter 150. Furthermore, in this position, the collection tube 102 is engaged with the needle 158 for sample collection. As the tube 102 is pulled out of the adapter 150, the first flange 5822 on the sleeve 5821 is caught on the end of the extension 5812 to pull the retaining ring 5811 from the adapter 150, at which point the collection / disposal tube 102 and the sleeve 5821 are removed therefrom. Fig.58CAs shown, when the assembly is stored or shipped, a removable clamp 5850 (e.g., configured with the same features as clamp 5750) is disposed around the tube 102 between the open end of the sleeve 5821 and the collar 5831 abutting the base of the adapter 150 and the sleeve 5831. The clamp 5850 prevents the tube 102 from being pushed into the adapter 150 prematurely, and the ring 5831 abutting 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 with the needle 158.

[0173] Fig.59 A proof of concept illustration of using an elastomeric tube to hold a collection / discard tube in a spaced relationship with a needle in an adapter during shipping but allowing the collection / discard tube to be advanced into engagement with the needle for sample collection. When the elastomeric tube is removed, the collection / discard tube can be engaged with the adapter needle for sample collection. When the desired amount of sample is collected, the collection / discard tube is removed from the adapter.

[0174] Fig.60 An extension (e.g., made of any suitable material) is shown extending from a sleeve on a collection / disposal tube to maintain the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. When the collection / disposal tube is advanced into engagement with the adapter needle for sample collection, the extension is brought into the adapter. When the collection / disposal tube is removed from the adapter, the extension is taken away with it.

[0175] Fig.61 yes Fig.60 A further modification of the illustrated aspect, also a proof of concept illustration of using an extension extending from a sleeve on a collection / disposal tube to hold the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. A band is used to hold the sleeve together. In certain aspects, the cardboard is corrugated to increase thickness and robustness. When the collection / disposal tube is advanced into engagement with the adapter needle for sample collection, the extension is brought into the adapter. When the collection / disposal tube is removed from the adapter, the extension is taken away with it.

[0176] Fig.62 yes Fig.60A further modification of the illustrated aspect is also a proof of concept illustration of using an extension extending from a sleeve on a collection / discard tube to hold the collection / discard tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / discard tube to be advanced into engagement with the needle for sample collection. A band is used to hold the sleeve together and hold the collection / discard tube in a spaced relationship with the adapter needle. In certain aspects, the cardboard is corrugated to increase thickness and sturdiness. When collection is initiated, the band holding the collection / discard tube in place is removed, allowing the collection / discard tube to be advanced into engagement with the adapter for sample collection, and the extension is brought into the adapter. When the collection / discard tube is removed from the adapter, the extension is taken away with it.

[0177] Fig.63 is a conceptual illustration of a sleeve structure for a collection / disposal tube that is wide enough not to enter the adapter, thereby keeping the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection. The collection / disposal tube can be advanced in the sleeve structure. After sample collection, squeezing the structure allows the collection / disposal tube assembled to the sleeve to exit the adapter.

[0178] FIG64 is a conceptual illustration of a sleeve structure for a collection / disposal tube that is wide enough not to enter the adapter, thereby keeping the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping but allowing the collection / disposal tube to be advanced into engagement with the needle for sample collection when the sleeve is squeezed. The collection / disposal tube can then be advanced in the sleeve structure. After sample collection, the structure is squeezed to allow the collection / disposal tube assembled to the sleeve to be withdrawn from the adapter.

[0179] Figure 65A-Figure 65B The invention is a valve assembly having a first adapter for receiving a collection / disposal tube and at least one other adapter for receiving a sample bottle. The assembly has an inlet that can be connected to a tubing set for collecting a sample from a patient. The valve can direct a first portion of the collected sample into the collection / disposal tube. After the desired amount of sample is collected, the valve is rotated and additional sample is directed to one or more sample containers.

[0180] Fig.66 yes Figure 65A-Figure 65B In this aspect, a pin is provided to prevent the valve from rotating beyond a position that would direct the sample out of the sample collection / disposal tube adapter unless the collection / disposal tube is engaged with a needle in the adapter.

[0181] Figure 67A-Figure 67BAn alternative aspect of the assembly described herein is shown, which deploys a collection / discard tube to communicate with an adapter for connection to a patient line set to collect a sample from a patient into a container. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle during shipping and storage. The collection / discard tube may have one of the many examples of a collar or sleeve or band described herein for maintaining such a spaced relationship between the collection / discard tube and the needle. The adapter has a valve on its end, which is placed to connect to a patient line set (not shown). The collection / discard tube is pushed into the adapter to collect the sample, after which the valve is opened. Once the initial portion of the patient sample is collected in the collection / discard tube, the collection / discard tube is removed from the adapter, and then the patient sample collection bottle is placed in fluid communication with the adapter needle for collecting the patient sample into a blood culture container.

[0182] Figure 68A-Figure 68B An alternative aspect of the assembly described herein is shown, which deploys a collection / discard tube to communicate with an adapter for connection to a patient line set to collect a sample from a patient into a container. In this aspect, the collection / discard tube is assembled with the adapter, but is maintained in a spaced relationship with the adapter needle by rotating a flap during shipping and storage. The adapter has a first port for receiving the collection / discard tube and a second port for receiving a blood culture bottle. The flap moves from a first position to a second position, the first position being located in the middle between the collection / discard tube and the adapter needle, thereby preventing the collection / discard tube from contacting the adapter needle during shipping and storage, and in the second position, the flap is positioned next to the collection / discard tube and is therefore no longer in the path between the collection / discard tube and the adapter needle. The collection / discard tube is advanced in the adapter, causing the flap to move from the first position to the second position. The collection / discard tube is advanced into the adapter to collect the sample, after which the valve is opened. Once the initial portion of the patient sample is collected into the collection / disposal tube, the collection / disposal tube is removed from the adapter and the patient sample collection bottle is placed in fluid communication with the adapter needle in the larger port for collection of the patient sample into the blood culture container.

[0183] Figure 69A-Figure 69B Show Figure 68A-Figure 68BAn alternative aspect of the dual-port adapter described in . The assembly described herein deploys a collection / discard tube to communicate with the dual-port adapter for connection to a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle during shipping and storage by a ring or other mechanism described herein. The adapter has a first port for receiving the collection / discard 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 in the port receiving the collection / discard tube is positioned on the pin in the second port. In this position, the pin cannot move upward and the culture bottle cannot contact the needle in the second port. When the collection / discard tube is advanced into fluid communication with the needle in the adapter, the lever moves away from above the pin and the pin can move upward, thereby allowing the culture bottle to be placed into fluid communication with the needle in the second port for collecting the rest of the sample. Once the initial portion of the patient sample is collected into the collection / disposal tube, the collection / disposal tube is removed from the adapter and the patient sample collection bottle is placed in fluid communication with the adapter needle in the larger port for collection of the patient sample into the blood culture container.

[0184] Figure 70A-70B Show Figure 69A-Figure 69B An alternative aspect of the dual-port adapter described in . The assembly described herein deploys a collection / discard tube to communicate with the dual-port adapter for connection with a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle by a ring or other mechanism described herein during shipping and storage. The adapter has a first port for receiving the collection / discard tube and a second port for receiving a blood culture bottle. The adapter also has a needle shuttle that will move the needle from the first port to the second port. The locking pin prevents the needle from moving from the first port to the second port until the sample is collected in the collection / discard tube in the first port. When the collection / discard tube is advanced into communication with the needle fluid in the adapter, the locking pin is moved upward, which allows the needle shuttle to move. Moving the needle shuttle will move the needle from the first port to the second port. The culture bottle can then be placed in communication with the needle fluid in the second port for collecting the rest of the sample. Once the initial portion of the patient sample is collected into the collection / disposal tube, the collection / disposal tube is removed from the adapter and the patient sample collection bottle is placed in fluid communication with the adapter needle in the larger port for collection of the patient sample into the blood culture container.

[0185] Fig.71 Show Figure 70A-70BAn alternative aspect of the dual-port adapter described in . The assembly described herein deploys a collection / discard tube to communicate with the dual-port adapter for connection with a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle by a ring or other mechanism described herein during shipping and storage. The adapter has a first port for receiving the collection / discard tube and a second port for receiving a blood culture bottle. The adapter also has a needle shuttle that will move the needle from the first port to the second port. In this aspect, the assembly lacks a locking pin. Once the initial portion of the patient sample is collected into the collection / discard tube, the collection / discard tube is removed from the adapter, which allows the needle shuttle to move from the first port to the second port, and then the patient sample collection bottle is placed in fluid communication with the adapter needle in the larger port for collecting the patient sample into the blood culture container. Moving the needle shuttle will move the needle from the first port to the second port. The culture bottle can then be placed in fluid communication with the needle in the second port for collecting the rest of the sample.

[0186] Figure 72A-72B An alternative aspect of a dual-port adapter is shown. The assembly described herein deploys a collection / discard tube to communicate with a dual-port adapter for connection with a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle by a ring or other mechanism described herein during shipment and storage. The adapter has a first port for receiving a collection / discard tube and a second port for receiving a blood culture bottle. The adapter also has a rotary valve, which in one position will allow a patient sample to flow into the collection / discard tube, and in a second position will allow a patient sample to flow into the blood culture bottle. Initially, before the sample is collected, the rotary valve is in a third position ("closed" position). When the collection / discard tube is in fluid communication with the needle in the adapter, the rotary valve is moved to the first position. Once the initial portion of the patient sample is collected in the collection / discard tube, the collection / discard 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 in fluid communication with the adapter needle.

[0187] Fig.73 yes Figure 72A-72B An alternative aspect of the invention wherein the adapter has a locking pin that requires the blood culture bottle to be inserted into the adapter before the rotary valve is moved to the third position.

[0188] Figure 74A-Figure 74BAn alternative aspect of a dual port adapter is shown. The assembly described herein deploys a collection / discard tube to communicate with a dual port adapter for connection with a patient line set to collect a sample from a patient into a container. The collection / discard tube will only fit into one of the dual ports. In this aspect, the collection / discard tube is assembled with the adapter, but is kept in a spaced relationship with the adapter needle by a ring or other mechanism described herein during shipment and storage. The adapter has a first port for receiving the collection / discard tube and a second port for receiving a blood culture bottle. These ports are staggered so that the collection / discard tube can be placed in one port and the culture bottle can be placed in another port at the same time, thereby providing a pressure difference between the flow path leading to the collection / discard tube and the flow path leading to the culture bottle. When the collection / discard tube is connected to the needle fluid in the adapter, the sample is collected in the sample collection / discard tube. Once the initial portion of the patient sample is collected in the collection / discard tube, the blood culture bottle is placed in communication with the needle fluid in the second port. Because the second port is lower than the first port (or more precisely, because the sample collection tube is held higher in the adapter than the blood culture set), the sample preferentially flows to the blood culture set when both the collection / disposal tube and the culture bottle are connected in the adapter.

[0189] Fig.75 is one aspect of a dual port adapter in which a sample collection / disposal tube is held in a spaced relationship with a needle in the adapter by various mechanisms described herein (eg, a rubber ring, clamp, fastener, or other spacing mechanism). Fig.75 Shown with Fig.71 A universal separation mechanism integrated with the sliding needle shuttle described in.

[0190] Fig.76 An adapter is shown in fluid communication with a sample collection / disposal tube. The adapter has a piezoelectric flow monitor that will indicate to the user when the sample collection / disposal tube contains a target amount of sample.

[0191] Fig.77 is an alternative aspect of a dual port adapter. Each port is attached to one end of a "Y" shaped connector. The port that receives the sample collection / disposal tube has a retaining mechanism that holds the collection / disposal tube in a spaced relationship with the needle in the adapter during shipping and storage. When the sample collection / disposal tube is placed in fluid communication with the needle in the adapter port, the line from the tubing set to the "Y" connector is primed. When sample is collected into the sample collection / disposal tube, the sleeve on the needle in the second port acts as a shutoff valve. 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.

[0192] Fig.78 yes Fig.77Another aspect of the dual port adapter of the present invention. Each port is attached to one end of a "Y" shaped connector, and the ports themselves are arranged in a "Y" shape. The port that receives the sample collection / discard tube has a retaining mechanism that holds the collection / discard tube in a spaced relationship with the needle in the adapter during shipping and storage. When the sample collection / discard tube is placed in fluid communication with the needle in the adapter port, the line from the tubing set to the "Y" connector is pre-charged. When the sample is collected into the sample collection / discard tube, the sleeve on the needle in the second port acts as a shut-off valve. When the 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 because the necessary amount of sample is in the collection / discard tube.

[0193] A sample collection system is described herein. In one aspect, the sample collection system includes: a container for collecting a sample; an adapter having a distal end, a proximal end, a needle, and an interior. The adapter is configured to receive a sample through a connector at the distal end. The needle extends from the connector to the interior of the adapter, and the proximal end includes an opening to receive 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 at a first position, wherein, at the first position, the first end of the container is maintained in a spaced relationship with the needle in the interior of the adapter. In one aspect, the fixing mechanism is operated to allow the container to be advanced distally from a first position to a second position within the interior of the adapter, thereby engaging the needle to receive the sample into the container. In one aspect, the fixing mechanism is further configured to enable the container to be withdrawn proximally to remove the container from the interior of the adapter. In another aspect, when the container is removed from the interior of the adapter, the fixing mechanism is configured to be removed by the container.

[0194] In one aspect, the securing mechanism includes a collar that fits over the container. In another aspect, the collar has an inner diameter that is greater than the outer diameter of the container and an outer diameter that is less than the inner diameter of the adapter. In another aspect, the collar provides an interference fit when pushed into the adapter. In yet another aspect, the collar has a flange that prevents the collar from being fully pushed into the adapter.

[0195] In another aspect, the securing mechanism is a c-clip.The securing mechanism may also have a resilient washer that is received on the container and forms an interference fit to the container within the adapter.

[0196] In another aspect, the container has a cap, which may have a septum and a shield. The shield may extend from the septum and surround a portion of the periphery of the container. In another aspect, the shield may have a first O-ring at a proximal end and a second O-ring at a distal end, each O-ring providing an interference fit when in the adapter.

[0197] In another aspect, the fixing mechanism is a collar on the container that forms a snap fit with the base of the shield, and when pushed into the adapter, the fixing mechanism provides an interference fit in the adapter. In another aspect, the collar has a flange at its proximal end to prevent the collar from being fully pushed into the adapter.

[0198] In another aspect, the adapter may have a spring on its interior that provides resistance as the container is advanced into the adapter and engages the needle, the spring being biased to push the container out of the adapter after sample collection.

[0199] In another aspect of the sample collection system, the securing mechanism is a flanged foam rubber ring placed on the container which forms an interference fit with the adapter when pushed into the adapter, the diameter of the flange being larger than the inner diameter of the adapter to prevent the flanged ring from being fully pushed into the adapter.

[0200] In another aspect of the sample collection system, the securing mechanism is a foam rubber collar placed on the container that seats within a flanged opening at the proximal end of the adapter, the foam rubber collar forming an interference fit with the container but allowing the container to be advanced and withdrawn through the collar.

[0201] In another aspect of the sample collection system, the securing mechanism is a foam rubber collar that is secured to the container and forms an interference fit when introduced into the adapter. In yet another aspect, the foam rubber collar is secured to the container with an adhesive.

[0202] In another aspect of the sample collection system, the securing mechanism can be a flanged O-ring on the container, wherein the O-ring forms a friction fit in the adapter when the container is advanced in the adapter, and wherein the flange is not advanced into the adapter. In this aspect, the container is movably received in the flanged portion.

[0203] On the other hand, the present invention describes a method for collecting a sample from a patient, the method comprising: providing a sample collection system as described above; manipulating a fixing mechanism of the sample collection system to allow a container to be advanced into communication with a needle fluid in an adapter; collecting a sample into the container; and removing the container from the adapter.

[0204] On the other hand, a sample collection system is described, comprising: a container for collecting a sample; an adapter having 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 to the interior of the adapter, and the proximal end including an opening to receive a first end of the container into the interior of the adapter; and a securing 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 spaced relationship with the needle in the interior of the adapter. In the above aspect, the securing mechanism is operated to allow the container to be advanced distally from the first position to a second position within the interior of the adapter, thereby engaging the needle to receive the sample into the container, wherein the securing mechanism is further configured to enable the container to be withdrawn proximally to remove the container from the interior of the adapter. Optionally, the securing mechanism is configured to be withdrawn by the container when the container is removed from the interior of the adapter.

[0205] On the other hand, the fixing mechanism is made of rubber and has an annular shape, wherein the fixing mechanism is arranged around the outside of the container, and wherein the fixing mechanism has: a distal portion comprising a thickness to be fitted between the container and the adapter; and a proximal portion comprising a flange having a diameter exceeding the inner diameter of the adapter.

[0206] In another aspect, the securing mechanism provides a snap fit with the shield of the container, the securing mechanism includes a lip extending away from the container and provides a stop that prevents the securing mechanism from being advanced further into the adapter.

[0207] In another aspect, the securing mechanism includes a compressible spring attached to a distal end of the container, the compressible spring being configured to be inserted between the container and the adapter, wherein the compressible spring retains the container in a first position but allows the container to be advanced into a second position when tension provided by the spring is overcome.

[0208] In another aspect, the securing mechanism includes a foam rubber flange that provides an interference fit on the container, wherein the container can be pushed from a first position to a second position in the foam rubber flange upon application of a force, and wherein a first portion of the foam rubber flange can be pushed into the adapter while a second portion of the foam rubber flange is too large to be pushed into the adapter.

[0209] In another aspect, the securing mechanism is a foam rubber flange that is adhesively secured to a corresponding flange at the base of the adapter.

[0210] In another aspect, the securing mechanism is a collar that forms a friction fit with the container such that the collar cannot be advanced into the adapter, but the container can be advanced through the collar from the first position to the second position.

[0211] In another aspect, the fixing mechanism is an O-ring, which is fixed to the container by a flange formed on the container.

[0212] In another aspect, a removable fastener is applied to the adapter and the container to secure the container in the first position.

[0213] In another aspect, the securing mechanism is a collar that retains an O-ring that forms an interference fit between the container and the adapter, wherein the collar is positioned adjacent the cap on the container.

[0214] In another aspect, the securing mechanism includes a collar that forms an interference fit with both an outer diameter of the container and an inner diameter of the adapter.

[0215] In another aspect, the securing mechanism further comprises a second portion, the second portion being a sleeve that fits over the container, wherein the sleeve comprises a flange that engages the collar such that when the container is removed from the adapter, the flange pulls the collar therefrom.

[0216] In another aspect, the securing mechanism includes a collar that forms an interference fit on the container, wherein the securing mechanism has a bearing therein.

[0217] In another aspect, the securing mechanism includes a ratchet collar, wherein the ratchet collar includes tabs that grip the container when the container is removed from the adapter.

[0218] In another aspect, the fixing mechanism is a one-way collar fitted on the container, the one-way collar comprising a tubular portion and a flange portion, wherein the tubular portion comprises a gripping portion on a surface in contact with the container.

[0219] In another aspect, the securing mechanism includes a collar and a ratchet that engages the base of the adapter and a flange that prevents the collar from being advanced into the adapter.

[0220] In another aspect, the securing mechanism includes a collar including a one-way clamp extending upwardly into the collar that fits over the container so that the container can only be advanced through the collar in one direction, wherein the securing mechanism further includes a band affixed to the container and the collar to secure the container in a first position, wherein the band is removed or torn when the container is advanced to a second position.

[0221] In another aspect, the securing mechanism includes a first collar portion and a second collar portion, each collar portion forming an interference fit with the container, wherein the first collar portion includes a receptacle for a barb on the second collar portion, wherein when the container is advanced into the second position, the first collar portion and the second collar portion are coupled together so that when the container is removed from the adapter, the first collar portion and the second collar portion are carried along with the container.

[0222] In another aspect, the securing mechanism comprises a snap ring including a protrusion that extends upwardly into the adapter when the snap ring is received by the adapter, the container carries a sleeve thereon, the sleeve carries an O-ring that forms an interference fit between the container and the adapter when the O-ring is pushed into the adapter, and the sleeve includes a raised portion that captures on the protrusion when the container is pushed into the adapter.

[0223] In another aspect, the securing mechanism includes a flanged sleeve, wherein the sleeve is flexible and wherein a radial gap exists between the sleeve and the container.

[0224] In another aspect, the securing mechanism has a first portion of a two-part collar including a clamp and a second portion including a collar that also provides an interference fit on the container, wherein when the container is advanced to the second position, the clamp advances through the second portion of the collar and when the container is removed from the adapter, the clamp pulls the second portion of the collar from the adapter.

[0225] In another aspect, the securing mechanism is a flanged sleeve including ratchets that engage the base of the adapter, wherein the ratchets can be rotated out of engagement with the base of the adapter to remove the container and the securing mechanism from the adapter.

[0226] In another aspect, the container is secured in the first position with the removable adhesive strip.

[0227] In another aspect, the securing mechanism is a threaded sleeve, wherein the threaded sleeve forms an interference fit with the container and is pushed upwardly into the adapter by screwing the sleeve into the adapter, wherein the container is withdrawn from the adapter by unscrewing the sleeve from the adapter.

[0228] In another aspect, the securing mechanism comprises a collar and a sleeve, wherein the collar comprises a guide recess for receiving a raised guide on the sleeve, the guide recess having ratchet teeth therein, the ratchet teeth holding the raised guide in place when the container is in the first position, wherein the sleeve further comprises a tab biased outwardly so that the tab carries the collar away from the adapter when the container is removed from the adapter.

[0229] In another aspect, the securing mechanism includes a collar and a sleeve, wherein the collar includes a clamp configured to attach to a base of an adapter and a tapered inner portion that receives a sleeve, wherein the sleeve has: a first raised portion that cooperates with a ratchet on an interior of the sleeve to retain the container in a first position; and a second raised portion that deflects the sleeve, whereby the clamp disengages from the base, allowing the container to be removed from the adapter.

[0230] In another aspect, the securing mechanism is a collar with a post that cooperates with a first transverse slot and a second linear slot that intersects the first transverse slot and is provided in the adapter, wherein the slots receive the post to allow the container to be locked in a first position by rotating the container so that the post on the collar is received in the transverse slot, and if the container is rotated so that the post is in the linear slot, the container can be advanced into a second position or removed from the adapter.

[0231] In another aspect, the securing mechanism is a collar with a post that cooperates with a first inclined slot and a second linear slot that intersects the first inclined slot and is provided in an adapter, wherein the inclined slot receives the post to allow the container to be locked in a first position, and to advance the container to a second position, the container is rotated so that the post is in the linear slot, which allows the container to be advanced into the second position or removed from the adapter.

[0232] In another aspect, the securing mechanism includes a collar with a post that cooperates with an open slot track in the adapter, wherein the slot track engages the post at a first end, at which the track retains the post so that the container is retained in a first position in the adapter, wherein rotating the container moves the post into a portion of the track that allows the container to be advanced to a second position, wherein rotating the container again advances the post into a portion of the track that allows the container to be removed from the adapter, the container bringing the collar out of the adapter.

[0233] In another aspect, the portion of the slot track that retains the container in the first position includes a ratchet that retains the post in place.

[0234] In another aspect, the securing mechanism includes a collar and sleeve assembly, the collar including a first portion received in the adapter and a flange portion that will not be advanced into the adapter, the collar also including an offset ratchet pin, the offset ratchet pin including a locking ratchet and a driven ratchet that locks into a slot provided in the adapter, the sleeve including a slot having an angled portion and a longitudinal portion, wherein when the ratchet pin is aligned with the angled portion of the slot, the container is locked in a first position by the locking ratchet, and wherein when the ratchet pin is aligned with the longitudinal portion of the slot so that the locking ratchet is no longer retained in the adapter slot, the container can be advanced into a second position or removed from the adapter.

[0235] In another aspect, the securing mechanism includes a collar and sleeve assembly, the collar including a flexible post and the sleeve including a flange that will not be advanced into an adapter, wherein the adapter includes a deflectable tab positioned to be received by a slot in the sleeve to lock the container in a first position in the adapter, wherein advancing the collar into the container causes the flexible post to move the deflectable tab out of engagement with the slot in the sleeve, allowing the container to be advanced to a second position or out of the adapter.

[0236] In another aspect, the securing mechanism comprises: a sleeve comprising a stop, a first slot, a second slot, and a flange that prevents the sleeve from being fully advanced into the adapter; and a collar comprising a raised portion and a flexible protrusion biased toward the interior of the adapter in which the container is received, and a rib, wherein the rib engages the container on which the sleeve is placed, wherein the adapter comprises an inwardly biased protrusion, wherein the protrusion engages the sleeve slot to retain the container in a first position, and wherein the raised portion of the collar moves the protrusion out of engagement with the sleeve slot to allow the container to be advanced to the second position and locks the collar to the sleeve, allowing the sleeve and collar to be removed together with the container.

[0237] Based on the above and with reference to the various drawings, those skilled in the art will recognize that certain modifications can be made to the present disclosure without departing from the scope of the present disclosure. Although several embodiments of the present disclosure have been shown in the drawings, this does not mean that the present disclosure is limited thereto, because the scope of the present disclosure is intended to be as wide as the art will allow and the specification should be read similarly. Therefore, the above description should not be regarded as restrictive, but merely as an example of a specific embodiment. Those skilled in the art will appreciate other modifications that fall within the scope and spirit of the appended claims.

Claims

1. A sample collection system comprising: A container for collecting a sample; an adapter comprising a distal end, a proximal end, a needle, and an interior, the adapter being configured to receive a sample through a connector at the distal end, the needle extending from the connector to the interior of the adapter, and the proximal end comprising an opening to receive the first end of the container into the interior of the adapter; and a securing mechanism configured to releasably secure the container in a first position wherein, in the first position, the first end of the container is held in spaced relationship with the needle in the interior of the adapter, wherein the securing mechanism is operated to allow the container to be advanced distally within the interior of the adapter from the first position to a second position thereby engaging the needle to receive the sample into the container, wherein the securing mechanism is further configured to enable proximal withdrawal of the container to remove the container from the interior of the adapter, Wherein, when the container is removed from the interior of the adapter, the securing mechanism is configured to be removed by the container.

2. The sample collection system of claim 1, wherein the securing mechanism comprises a collar that fits over the container.

3. The sample collection system of claim 2, wherein the collar has an inner diameter greater than an outer diameter of the container and an outer diameter less than an inner diameter of the adapter.

4. The sample acquisition system of any one of claims 2 and 3, wherein the collar provides an interference fit when advanced into the adapter.

5. The sample acquisition system of any one of claims 2-4, wherein the collar has a flange that prevents the collar from being fully advanced into the adapter. The sample acquisition system of claim 1 , wherein the securing mechanism is a C-clip.

7. The sample acquisition system of claim 6, wherein the securing mechanism further comprises a resilient washer received on the container and forming an interference fit with the container within the adapter.

8. The sample acquisition system of claim 1, wherein the container has a cap including a septum and a shield extending from the septum and surrounding a periphery of a portion of the container.

9. The sample collection system of claim 8, wherein the securing mechanism is a collar on the container that forms a snap fit with a base of the shield, and when pushed into the adapter, the securing mechanism provides an interference fit in the adapter.

10. The sample acquisition system of claim 9, wherein the collar has a flange at its proximal end to prevent the collar from being fully advanced into the adapter.

11. The sample collection system of claim 1 , wherein the adapter has a spring on its interior that provides resistance when the container is advanced into the adapter and engages the needle, the spring being biased to push the container out of the adapter after sample collection.

12. The sample collection system of claim 1 , wherein the securing mechanism is a flanged foam rubber ring placed on the container, wherein the flanged foam rubber ring forms an interference fit with the adapter when pushed into the adapter, and wherein the diameter of the flange is greater than the inner diameter of the adapter to prevent the flanged ring from being fully pushed into the adapter.

13. The sample collection system of claim 1 , wherein the securing mechanism is a foam rubber collar placed on the container, the foam rubber collar seated within a flanged opening at the proximal end of the adapter, the foam rubber collar forming an interference fit with the container but allowing the container to be advanced and withdrawn through the collar.

14. The sample acquisition system of claim 1, wherein the securing mechanism is a foam rubber collar that is secured to the container and forms an interference fit when introduced into the adapter.

15. The sample collection system of claim 14, wherein the foam rubber collar is secured to the container with an adhesive.

16. The sample collection system of claim 1 , wherein the securing mechanism is a flanged and O-ring collar on the container, wherein the O-ring forms a friction fit in the adapter when the container is advanced in the adapter and wherein the flange is not advanced into the adapter, wherein the container is movably received in the flange.

17. The sample acquisition system of claim 8, wherein the shield has a first O-ring at a proximal end and a second O-ring at a distal end, each O-ring providing an interference fit when in the adapter.

18. A sample collection system comprising: A container for collecting a sample; an adapter comprising a distal end, a proximal end, a needle, and an interior, the adapter being configured to receive a sample through a connector at the distal end, the needle extending from the connector to the interior of the adapter, and the proximal end comprising an opening to receive the first end of the container into the interior of the adapter; and a securing mechanism configured to retain the container in a first position wherein the first end of the container is retained in a spaced relationship with the needle in the interior of the adapter, wherein the securing mechanism is configured to allow the container to be advanced distally from the first position to a second position within the interior of the adapter to engage the needle to receive the sample into the container, wherein the securing mechanism is further configured to enable proximal withdrawal of the container to remove the container from the interior of the adapter, Wherein, when the container is removed from the interior of the adapter, the securing mechanism is configured to be withdrawn by the container.

19. The sample collection system of claim 18, wherein the fixing mechanism is made of rubber and has an annular shape, wherein the fixing mechanism is disposed around the exterior of the container, and wherein the fixing mechanism has: a distal portion comprising a thickness to be fitted between the container and the adapter; and a proximal portion comprising a flange having a diameter exceeding an inner diameter of the adapter.

20. The sample acquisition system of claim 18, wherein the securing mechanism provides a snap fit with a shield of the container, the securing mechanism includes a lip extending away from the container and provides a stop that prevents the securing mechanism from being advanced further into the adapter.

21. A sample collection system according to claim 18, wherein the securing mechanism comprises a compressible spring attached to a distal end of the container, the compressible spring being configured to be inserted between the container and the adapter, wherein the compressible spring holds the container in the first position but allows the container to be advanced into the second position when the tension provided by the spring is overcome.

22. The sample collection system of claim 18, wherein the securing mechanism comprises a foam rubber flange that provides an interference fit on the container, wherein the container can be urged from the first position to the second position in the foam rubber flange upon application of a force, and wherein a first portion of the foam rubber flange can be urged into the adapter while a second portion of the foam rubber flange is too large to be urged into the adapter.

23. The sample acquisition system of claim 18, wherein the securing mechanism is a foam rubber flange that is adhesively secured to a corresponding flange at the base of the adapter.

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

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

26. The sample acquisition system of claim 25, wherein a removable fastener is applied to the adapter and container to secure the container in the first position.

27. The sample acquisition system of claim 18, wherein the securing mechanism is a collar that holds an O-ring that forms an interference fit between the container and the adapter, wherein the collar is positioned adjacent a cap on the container.

28. The sample acquisition system of claim 18, wherein the securing mechanism comprises a collar that forms an interference fit with both an outer diameter of the container and an inner diameter of the adapter.

29. The sample collection system of claim 28, wherein the securing mechanism further comprises a second portion, the second portion being a sleeve that fits over the container, wherein the sleeve comprises a flange that engages the collar so that when the container is removed from the adapter, the flange pulls the collar therefrom.

30. The sample collection system of claim 18, wherein the securing mechanism comprises a collar forming an interference fit on the container, wherein the securing mechanism has a bearing therein.

31. The sample acquisition system of claim 18, wherein the securing mechanism comprises a ratchet collar, wherein the ratchet collar includes tabs that grip the container when the container is removed from the adapter.

32. The sample collection system of claim 18, wherein the securing mechanism is a one-way collar fitted on the container, the one-way collar comprising a tubular portion and a flange portion, wherein the tubular portion comprises a gripping portion on a surface in contact with the container.

33. The sample acquisition system of claim 18, wherein the securing mechanism comprises a collar and a ratchet that engages a base of the adapter and a flange that prevents the collar from being advanced into the adapter.

34. A sample collection system according to claim 18, wherein the fixing mechanism includes a ring, the ring includes a one-way clamping portion, the one-way clamping portion extends upwardly into the ring that fits on the container so that the container can only be advanced through the ring in one direction, wherein the fixing mechanism also includes a band attached to the container and the ring to fix the container in the first position, wherein when the container is advanced to the second position, the band is removed or torn.

35. The sample collection system of claim 18, wherein the securing mechanism comprises a first collar portion and a second collar portion, each collar portion forming an interference fit with the container, wherein the first collar portion comprises a receptacle for a barb on the second collar portion, wherein when the container is advanced into the second position, the first collar portion and the second collar portion are coupled together such that when the container is removed from the adapter, the first collar portion and the second collar portion are carried along with the container.

36. The sample collection system of claim 18, wherein the securing mechanism comprises a snap ring, the snap ring comprising a protrusion that extends upwardly into the adapter when the snap ring is received by the adapter, the container carrying a sleeve thereon, the sleeve carrying an O-ring that forms an interference fit between the container and the adapter when the O-ring is advanced into the adapter, the sleeve comprising a raised portion that captures on the protrusion when the container is advanced into the adapter.

37. The sample acquisition system of claim 18, wherein the securing mechanism comprises a flanged sleeve, wherein the sleeve is flexible and wherein a radial gap exists between the sleeve and the container.

38. The sample collection system of claim 18, wherein the securing mechanism comprises a two-part collar, a first portion of the two-part collar comprising a clamp and a second portion comprising a collar, the collar also providing an interference fit on the container, wherein when the container is advanced to the second position, the clamp advances through the second portion of the collar, and when the container is removed from the adapter, the clamp pulls the second portion of the collar from the adapter.

39. The sample collection system of claim 18, wherein the securing mechanism is a flanged sleeve comprising a ratchet that engages with a base of the adapter, wherein the ratchet can be rotated out of engagement with the base of the adapter to remove the container and the securing mechanism from the adapter.

40. The sample acquisition system of claim 39, wherein the container is secured in the first position with a removable adhesive strip.

41. A sample collection system according to claim 18, wherein the fixing mechanism is a threaded sleeve, wherein the threaded sleeve forms an interference fit with the container and is pushed upward into the adapter by screwing the sleeve into the adapter, and wherein the container is withdrawn from the adapter by unscrewing the sleeve from the adapter.

42. A sample collection system according to claim 18, wherein the fixing mechanism includes a ring and a sleeve, wherein the ring includes a guide recess for receiving a raised guide on the sleeve, and the guide recess has a ratchet therein, and when the container is in the first position, the ratchet holds the raised guide in place, and the sleeve also includes a wing, which is biased outward so that when the container is removed from the adapter, the wing takes the ring away from the adapter.

43. The sample collection system of claim 18, wherein the securing mechanism comprises a collar and a sleeve, wherein the collar comprises a clamp configured to attach to a base of the adapter and a tapered inner portion that receives the sleeve, wherein the sleeve has: a first raised portion that cooperates with a ratchet on an interior of the sleeve to retain the container in the first position; and a second raised portion that deflects the sleeve, whereby the clamp disengages from the base, allowing the container to be removed from the adapter.

44. A sample collection system according to claim 18, wherein the fixing mechanism is a collar with a post, the post cooperating with a first transverse slot and a second linear slot, the first transverse slot intersecting the second linear slot and being provided in the adapter, wherein the slot receives the post to allow the container to be locked in the first position by rotating the container so that the post on the collar is received in the transverse slot, and if the container is rotated so that the post is in the linear slot, the container can be advanced into the second position or removed from the adapter.

45. A sample collection system according to claim 18, wherein the fixing mechanism is a collar with a post, the post cooperating with a first inclined slot and a second linear slot, the first inclined slot intersecting the second linear slot and being provided in the adapter, wherein the inclined slot receives the post to allow the container to be locked in the first position, and in order to advance the container to the second position, the container is rotated so that the post is in the linear slot, which allows the container to be advanced into the second position or removed from the adapter.

46. ​​A sample collection system according to claim 18, wherein the securing mechanism includes a collar with a post, wherein the post cooperates with an open slot track in the adapter, wherein the slot track engages the post at a first end, at which the track holds the post so that the container is held in the first position in the adapter, wherein rotating the container moves the post into a portion of the track that allows the container to be advanced to the second position, wherein rotating the container again advances the post into a portion of the track that allows the container to be removed from the adapter, and the container brings the collar out of the adapter.

47. The sample acquisition system of claim 46, wherein the portion of the slot track that retains the container in the first position includes a ratchet that holds the post in place.

48. A sample collection system according to claim 18, wherein the securing mechanism includes a collar and sleeve assembly, the collar including a first portion that is received in the adapter and a flange portion that will not be advanced into the adapter, the collar also including a biasing ratchet pin, the biasing ratchet pin including a locking ratchet and a driven ratchet that locks into a slot provided in the adapter, the sleeve including a slot having an angled portion and a longitudinal portion, wherein when the ratchet pin is aligned with the angled portion of the slot, the container is locked in the first position by the locking ratchet, and wherein when the ratchet pin is aligned with the longitudinal portion of the slot so that the locking ratchet is no longer retained in the adapter slot, the container can be advanced into the second position or removed from the adapter.

49. A sample collection system according to claim 18, wherein the securing mechanism includes a ring and sleeve assembly, the ring includes a flexible post and the sleeve includes a flange that will not be advanced into the adapter, wherein the adapter includes a deflectable tab positioned to be received by a narrow slot in the sleeve to lock the container in the first position in the adapter, wherein advancing the ring into the container causes the flexible post to move the deflectable tab without engaging the narrow slot in the sleeve, allowing the container to be advanced to the second position or pushed out of the adapter.

50. The sample acquisition system of claim 18, wherein the securing mechanism comprises: a sleeve including a stop, a first slot, a second slot, and a flange that prevents the sleeve from being fully advanced into the adapter; and a collar comprising a raised portion and a flexible protrusion biased toward an interior of the adapter in which the container is received, and a rib, wherein the rib engages the container on which the sleeve is placed, wherein the adapter comprises an inwardly biased protrusion, wherein the protrusion engages a first sleeve slot to retain the container in the first position, and wherein the raised portion of the collar moves the protrusion out of engagement with the first sleeve slot to allow the container to be advanced to the second position and lock the collar to the sleeve, allowing the sleeve and collar to be removed with the container.

51. A sample collection system according to claim 18, wherein the fixing mechanism includes a sleeve attached to the container, the sleeve having a larger diameter portion, wherein the adapter includes a base portion with a window, the window receiving a tab on a locking oval ring, the locking oval ring retaining the container and the sleeve thereon in the first position in its relaxed state, and as the larger diameter portion of the sleeve is pushed into the locking oval ring, the oval ring expands, causing the tab to withdraw from the adapter window and attach to the sleeve.

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