WO2013067353A1

WO2013067353A1 - Biological sample collection, homogenization, and separation device

Info

Publication number: WO2013067353A1
Application number: PCT/US2012/063326
Authority: WO
Inventors: Amaresh AGRAHARA; Christian Valcke; John L. PASSMORE; Karen L. MENGE; Daniel DORNBUSCH; Keith L. CHUN; David G. SHERMAN; Jody A. MELTON WITT; Taylor G. SANDISON; Mark West; Gaurav Rohatgi; Allan Cameron; Elizabeth KEEN; Jeremy Zietz; Bernadette J. MCCRORY
Original assignee: Novartis Ag
Priority date: 2011-11-04
Filing date: 2012-11-02
Publication date: 2013-05-10

Abstract

Devices and techniques for collecting and homogenizing biological samples in a closed environment are presented. A sample collection unit with a mechanical homogenizer located within a sample collection volume is described, as well as a technique for using the same. The sample collection unit may be sized for use in a hospital environment, including pneumatic delivery systems.

Description

BIOLOGICAL SAMPLE COLLECTION, HOMOGENIZATION, AND SEPARATION DEVICE

BACKGROUND OF THE INVENTION

[0001] Biological sample collection in the hospital setting may occur in various ways depending on the nature of the sample to be collected. One device which is in widespread use is a Lukens trap, which is a cylindrical container with a screw-top lid. The Lukens lid includes two nipples which protrude out of the top of the lid. The first nipple exits the lid near the edge of the Lukens lid. The second nipple protrudes from the center of the Lukens lid and also extends into the volume of the Lukens container some distance when the Lukens lid is attached. A vacuum, source is connected to the center nipple via a flexible hose, and a sample source is connected to the outer nipple using another flexible hose. The vacuum is used to draw the sample into the Lukens trap. After a desired quantity of sample is collected, the vacuum and sample sources are disconnected, and a short length of tubing is used to join both nipples and seal the Lukens trap against contamination of, or contagion from, the collected sample. In some Lukens trap implementations, rather than joining the nipples via a short length of tubing to seal the Lukens trap, the entire lid is removed and replaced with a lid without nipples or other leak paths. To remove the sample, the Lukens lid is typically unscrewed and the sample either poured out or withdrawn using a syringe or other instrument.

SUMMARY OF THE INVENTION

[0002] In some implementations according to this disclosure, a biological sample collection device is provided. The sample collection device may include a handheld sample collection unit (SCU) including an internal sample collection volume and a mechanical homogenizer located within the sample collection volume. In some implementations, the biological sample collection device may be configured to allow air trapped in the sample collection volume to escape while fluids or solids in the sample collection volume are retained. Some

implementations of the sample collection device may further include a sample removal device with a second sample collection volume. The sample removal device may be removably installed in the biological sample collection device. When installed in the sample collection device, the sample removal device may fluidly communicate with the sample collection volume to allow at least a portion of a sample collected with the sample collection device to be transferred into the second sample collection volume. The sample removal device may also prevent the sample collected within the sample collection volume from escaping into the ambient environment when the sample collected with the sample collection device is transferred into the second sample collection volume. In some implementations, the sample removal device may be configured to accept no more than a pre-set amount of the sample collected with the sample collection device. In some implementations, the SCU may fit within a cylindrical volume having a diameter of approximately 1.75 inches and a length of 5.5 inches.

[0003] In some implementations, the SCU may allow the mechanical homogenizer and the sample collection volume to translate, or reciprocate, relative to each other. In some further implementations, the SCU may also allow the mechanical homogenizer and the sample collection volume to rotate about an axis parallel to the direction of translation relative to each other.

[0004] In some implementations, the mechanical homogenizer may include a flat plate with an outer edge substantially proximate to an interior surface of the sample collection volume along the perimeter of the flat plate and one or more openings providing fluidic

communication between opposite sides of the flat plate. In some further implementations, the SCU may also include a main body and a plunger. In such further implementations, the plunger may include a central portion which is configured to translate within the main body, the sample collection volume may be substantially defined by the central portion and by interior surfaces of the main body, and the sample collection volume may decrease when the central portion is translated into the main body. In some additional implementations, the plunger may further include an exhaust passage, which fluidly connects the sample collection volume with the ambient environment outside of the SCU, and a filter configured to permit gas flow through the exhaust passage while substantially preventing liquid flow through the exhaust passage. In some further implementations, the sample collection device may also include a base which is connected with the mechanical homogenizer, configured to remain stationary with respect to the mechanical homogenizer during reciprocating motion of the mechanical homogenizer and the sample collection volume relative to each other, and located substantially outside of the main body. In some implementations, the biological sample collection device may include a spring configured to bias the base and the flat plate away from the central portion. [0005] In some implementations, the biological sample collection device may include a port assembly; the port assembly may be removable. The port assembly may include a stem including a first end and a second end. A first suction port and a first sample port may be located at the first end of the stem, and a second suction port and a second sample port may be located at the second end of the stem. The first suction port may be configured to be connected to a suction source and the first sample port may be configured to be connected to a sample source. A suction passage may fluidly connect the first suction port with the second suction port, and a sample passage may fluidly connect the first sample port with the second sample port. The suction passage and the sample passage may be separate from each other and both housed within the stem. The biological sample collection device may also include a port aperture configured to receive the second end of the stem and permit the second end of the stem to be introduced into the sample collection volume and the second suction port and the second sample port to fluidly communicate with the sample collection volume.

[0006] In some implementations, the biological sample collection device may be a single- use, disposable device. Some implementations of a biological sample collection device may contain one or more chemicals selected from the group consisting of chemicals for stabilizing a biological sample, chemicals for preserving the biological sample, chemicals for pre- treating the biological sample, chemicals for promoting bacterial growth in the biological sample, chemicals for diluting the biological sample, and chemicals for indicating the presence of a particular organism or chemical in the biological sample.

[0007] In some further implementations, the plunger may also include a threaded feature and the main body may include a mating threaded feature. In such implementations, rotation of the plunger with respect to the main body in a first direction may cause the plunger to translate into the main body, and rotation of the plunger with respect to the main body in a second direction may cause the plunger to translate out of the main body.

[0008] In some implementations, the biological sample collection device the SCU may further include a sample aliquot unit. The sample aliquot unit may be in fluidic

communication with the sample collection volume and, when substantially all free gas within the sample collection volume has been bled away, rotation of the plunger in a first direction with respect to the main body may force sample material within the sample collection volume into the sample aliquot unit. In some further implementations, the plunger may include reference marks spaced about at least a portion of an external edge of the plunger in the vicinity of the main body and the main body includes a reference line. In such implementations, rotation of the plunger with respect to the main body by a distance corresponding with the distance between two of the reference marks may force a first amount of sample material into the sample aliquot unit.

[0009] In some implementations, the SCU may include a substantially tubular main body. In such implementations, the main body may include a region of the main body which forms a baffle within, and oriented substantially perpendicular to a major axis of, the main body. The main body may further include a first inner wall and a second inner wall. The first inner wall may be separated from the second inner wall by the baffle. Such implementations may also include a plunger with an exterior housing and an upper plug, as well as a base with a lower plug. The lower plug may be in sliding contact with a first inner wall of the main body, and the upper plug may be inserted into the main body such that the upper plug is in sliding contact with a second inner wall of the main body.

[0010] In some such implementations, when the upper plug is inserted into the main body, the base and plunger may be configured to allow for engagement of the plunger with the base, allow for further insertion of the upper plug into the main body while maintaining the engagement of the plunger with the base, and prevent retraction of the upper plug from the main body. In such implementations, the first inner wall, the second inner wall, a first surface of the upper plug facing the baffle, and a second surface of the lower plug facing the baffle may substantially define a sample collection volume, and the main body may be configured to slide relative to the upper plug and the lower plug, thereby translating the baffle within the sample collection volume. In some further implementations, the main body may be substantially radially symmetric, the first inner wall and the second inner wall may have matching diameters, and the baffle may be formed by a narrowing of the main body to a diameter substantially smaller than the matching diameters of the first inner wall and the second inner wall.

[0011] In some implementations, a technique for collecting a biological sample is provided. The technique may include collecting a biological sample within a hand-held sample collection unit (SCU) and homogenizing the biological sample by moving a first portion of the SCU with respect to a second portion of the SCU. In some further implementations, the homogenizing may be performed by reciprocating the first portion of the SCU with respect to the second portion of the SCU multiple times. In some implementations, the homogenizing may be performed without opening the SCU. [0012] In some implementations, the first portion may include a plunger and a main body, the second portion may include a base and a homogenizer plate. In such implementations, the homogenizing may be performed by translating the plunger and the main body with respect to the base and the homogenizer plate. In some such implementations, the translating may be performed multiple times.

[0013] Further understanding of the above implementations, as well as other

implementations or features, may be gained through reference to the accompanying drawings and detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Fig. 1 depicts a high-level conceptual diagram of an SCU with an integrated homogenization capability.

[0015] Fig. 2A depicts an isometric view of one implementation of an SCU.

[0016] Fig. 2B depicts an isometric view of a port unit for an SCU as depicted in Fig. 2A.

[0017] Fig. 2C depicts an isometric section view of a port unit for an SCU as depicted in Fig.

2A.

[0018] Fig. 2D depicts an alternate isometric section view of a port unit for an SCU as depicted in Fig. 2A.

[0019] Fig. 2E depicts an isometric section view of the SCU depicted in Fig. 2A.

[0020] Fig. 2F depicts an isometric exploded view of the SCU depicted in Fig. 2A.

[0021] Fig. 2G depicts a side section view of the SCU depicted in Fig. 2A prior to sample collection.

[0022] Fig. 2H depicts a side section view of the SCU depicted in Fig. 2A after sample collection and port unit removal.

[0023] Fig. 21 depicts a side section view of the SCU depicted in Fig. 2A after excess air has been bled out.

[0024] Fig. 2 J depicts a side section view of the SCU depicted in Fig. 2A during

homogenization.

[0025] Fig. 2K depicts another side section view of the SCU depicted in Fig. 2A during homogenization.

[0026] Fig. 2L depicts a side section view of the SCU depicted in Fig. 2A during cap removal.

[0027] Fig. 2M depicts a side section view of the SCU depicted in Fig. 2A during aliquot fill. [0028] Fig. 2 depicts a side section view of the SCU depicted in Fig. 2A during aliquot removal.

[0029] Fig. 3A depicts a labeling scheme for one implementation of an SCU.

[0030] Fig. 3B depicts another labeling scheme for one implementation of an SCU .

[0031] Fig. 3C depicts a tab indicator scheme for one implementation of an SCU.

[0032] Fig. 3D depicts a mix/not mixed indicator scheme for one implementation of an SCU.

[0033] Fig. 4 is a flow diagram of one technique of using an SCU.

[0034] Fig. 5A depicts an isometric view of an alternate SCU implementation.

[0035] Fig. 5B depicts an isometric section view of the SCU implementation depicted in Fig.

5A.

[0036] Fig. 5C depicts an isometric exploded view of the SCU implementation depicted in Fig. 5A.

[0037] Fig. 5D depicts a side section view of the SCU of Fig. 5 A prior to sample collection.

[0038] Fig. 5E depicts a side section view of the SCU of Fig. 5 A after sample collection.

[0039] Fig. 5F depicts a side section view of the SCU of Fig. 5A after Lukens cap removal.

[0040] Fig. 5G depicts a side section view of the SCU of Fig. 5A prior to SCU plunger installation.

[0041] Fig. 5H depicts a side section view of the SCU of Fig. 5A after excess air has been bled from the SCU.

[0042] Fig. 51 depicts a side section view of the SCU of Fig. 5A after aliquot installation.

[0043] Fig. 5J depicts another side section view of the SCU of Fig. 5A during

homogenization.

[0044] Fig. 5K depicts another side section view of the SCU of Fig. 5A during

homogenization.

[0045] Fig. 5L depicts another side section view of the SCU of Fig. 5A during

homogenization.

[0046] Fig. 5M depicts another side section view of the SCU of Fig. 5A during

homogenization.

[0047] Fig. 5 depicts another side section view of the SCU of Fig. 5A during aliquot fill.

[0048] Fig. 20 depicts another side section view of the SCU of Fig. 5A during aliquot removal.

[0049] Figures 2A-2 and 5A-50 are drawn to scale, although it is to be understood that other implementations with different dimensions, form factors, and components may also be used in accordance with the principles and concepts described herein, and the fact that some implementations described herein are depicted with figures drawn to scale should not be viewed as limiting the disclosure herein to only those implementations.

DETAILED DESCRIPTION

[0050] Reference will now be made in detail to specific implementations of the invention. Examples of the specific implementations are illustrated in the accompanying drawings. While the invention will be described in conjunction with these specific implementations, it will be understood that it is not intended to limit the invention to such specific

implementations. On the contrary, it is intended to cover alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention. In the following description, numerous specific details are set forth in order to provide a thorough

understanding of the present invention. The present invention may be practiced without some or all of these specific details. In other instances, well known mechanical apparatuses and/or process operations have not been described in detail in order not to unnecessarily obscure the present invention.

[0051] It should also be understood that, unless a term is expressly defined in this patent using the sentence "As used herein, the term ' ' is hereby defined to mean..." or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term by limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word "means" and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. § 1 12, sixth paragraph.

[0052] At a high level, biological sample collection unit (SCU) 100 is provided for collecting biological samples, as shown in Fig. 1. SCU 100 may be used in a hospital setting and may be designed to be a single-use, disposable component. SCU 100 includes sample collection volume (SCV) 102 and mechanical homogenizer 104, which is contained within sample collection volume 102. Mechanical homogenizer 104 may be used to manipulate a sample collected using SCU 100 and render the sample more homogenous. Mechanical homogenizer 100 allows the sample collected using SCU 100 to be homogenized without removing the sample from SCV 102. Sample inlet 106 may be used to introduce the sample to SCV 102. Sample outlet 108 may be used to extract the sample; sample outlet 108 may also serve to provide suction to draw the sample into sample inlet 106. In some implementations, sample inlet 106 and sample outlet 108 may not be required.

[0053] SCU 100 may be configured to receive a collected biological sample at or near the site of collection, e.g., bedside, and provide for safe transport from the collection site to a remote analysis site, e.g., pathology lab. SCU 100 may also be configured to provide for mechanical homogenization of the collected biological sample at either the collection site, the analysis site, or during transit. The mechanical homogenization may be performed manually without opening SCU 100 and without equipment in addition to SCU 100. It is to be understood that "mechanical homogenization," as used herein, refers to the technique of rendering a biological sample more homogenous through the movement of mechanical parts within the sample collection volume. The biological sample, in the case of an SCU used to collect sputum, may include material such as clots of blood, phlegm, mucus, saliva, or other substances which may be found in a respirator tract, for example. Such substances may take the form of a mucoidal, non-homogenous fluid or mass. For example, mucus may be described as a viscous, slimy, non-homogenous mixture of mucins, water, electrolytes, epithelial ceils, leukocytes, and other biological materials that is secreted by glands lining the nasal, esophageal, and other body cavities and serves primarily to protect and lubricate surfaces. Mucus may also include biological and non-biological materials which are not secreted by the organism, but which are foreign to the organism and entrained in the mucus. For example, mucus may include soot, dust, pollens, spores, etc. Depending on the conditions, mucus may also solidify wholly or partially due to moisture loss and other factors.

[0054] It is to be further understood that while a collected biological sample may be rendered somewhat more homogenous by simply shaking or otherwise manipulating the orientation or position of the vessel containing the sample, such actions do not constitute "mechanical homogenization" as used herein since the volume containing the collected sample does not include mechanical parts which move relative to the volume or a volume which moves relative to a mechanical part or parts. In some implementations, it is to be understood that the mechanical liomogenizer is rigidly connected with the SCU, i.e., the mechanical liomogenizer is not free to move about the SCV in any direction, but, due to the rigid connection with the SCU, is constrained in its path of movement within the SCV. In some implementations, it is to be understood that the mechanical homogenizer may be activated by moving a portion of the SCU rigidly connected with the with respect to another portion of the SCU; one of the two portions of the SCU may be fixed in space during operation, i.e., the mechanical homogenizer may be operated without moving the entire SCU during homogenization.

[0055] The degree of homogenization imparted by the SCU may vary, although some implementations may involve mechanical homogenizers which may displace substantially all of the collected sample during a single homogenization cycle. In some implementations, the various components of SCU 100 may be broken down into no more than two separate groups. During homogenization in these implementations, the components in one group may move together, i.e., in the same direction and by the same amount, and the components in the other group may also move together, although each group may move in opposite directions with respect to the other group.

[0056] For example, SCU 100 may be connected to a vacuum source and a sample source (not shown). The vacuum source may be used to draw a sample into SCU 100, where the sample collects in sample collection volume 102. After the sample is collected, the sample source and vacuum source may be disconnected, and mechanical homogenizer 104 may be activated to homogenize the sample. Such a configuration may be used, for example, to collect sputum samples from a respiratory tract via a ventilator.

[0057] In some other implementations, a sample may be introduced to SCU 100 manually, such as via a scoop, spatula, or other instrument. SCU 100 may have a removable cover to facilitate, such introduction. After introduction of the sample, the cover may be reinstalled and mechanical homogenizer 104 activated. Such a configuration may be used, for example, for blood, urine, or stool samples.

[0058] Figs. 2A through 2N depict one implementation of an SCU which is configured for use in collecting sputum samples in conjunction with a ventilator. Items appearing in multiple figures in Figs. 2A-2N are numbered identically in each Figure. Fig. 2A depicts SCU 200, which includes main body 204, plunger 202, and base 206. Also shown is port unit 208 and cap 210, which are removable from SCU 200 during ordinary use. Port unit 2,08, for example, may be removed from SCU 200 by pulling on handle 218, which may be releasabiy clamped to main body 204 by port clip 236. Port unit 208 may include sample port 216 and suction port 214, which, may be connected, for example, to a intubated patient and ventilator or facility vacuum source, respectively. SCU 200 may be designed to be hand-held, lightweight, and disposable. For example, plunger 202 may be approximately 1.75" in diameter and SCU 200 may be approximately 5.5" in length in the configuration shown in Fig. 2A.

[0059] Fig. 2B-2D depict port unit 208 in various isometric views. Fig. 2B depicts port unit 208 in an isometric view. Port clip 256 is designed to snap around main body 204 and anchor port unit 208 in place when installed in SCU 200. Also visible are nipples for suction port 214 and collection port 216, as well as handle 218. Other fittings may be used as well, such as quick-disconnect fittings, barbed hose fittings, threaded fittings, etc. Fig. 2C depicts an isometric sectional view of port unit 208; the section plane in this view is oriented to be parallel to the center axis of SCU 200. As is evident from Fig. 2C, suction port 214 and collection port 216 may share a common path through the wall of main body 204 into sample collection volume (SCV) 230 (SCV 230 is not shown in Figs. 2B-2D, but the interplay between port unit 208 and SCV 230 is visible in, for example, Figs. 2E and 2G). In other implementations, however, the suction and collection ports may be fluidly connected to SCV 230 using separate pathways through or around main body 204. Collection port 216 may be fluidly connected to SCV 230 via interior collection port 258, which may be disposed at the end of riser 260, which may be used to spatially separate incoming sample material from suction provided by suction port 216. Fig. 2D depicts another isometric section view of port unit 208; the section plane in Fig. 2D is oriented to be perpendicular to the center axis of SCU 200. Arrows showing flow directions have also been added to Fig. 2D. White arrows are used to show gaseous flow from SCV 230 through interior suction port 242 and out suction port 214. Black arrows are used to show fluid flow into SCV 230 via interior collection port 258 and collection port 216.

[0060] SCU 200 may be sized sufficiently small enough to be transported using pneumatic tube or capsule, pipeline delivery systems used by some hospitals. These are systems in which pay loads, such as SCU 200, are loaded into capsules which are then introduced into a pneumatic tube. The pneumatic pressure in the tube causes the capsule to travel along the path of the tube until the final destination of the tube is reached. Hospitals may use such systems to allow for the rapid deliver}' of biological samples to a pathology lab. Due to the twists and turns which a pneumatic capsule may undergo during delivery, payloads carried by the capsules may be exposed to a significant degree of shock and vibration, which may negatively affect some payloads. Luken's traps, for example, may become unsealed if the tube joining both nipples becomes loose. ^'This not only can contaminate the sample, but may introduce undesired biological material throughout the capsule or tube system. SCU 200, due to its compact design and more robust sealing system, is safer to use with pneumatic tube systems.

[0061] Reference is now made to Figs. 2E and 2F, which depict SCU 200 in an isometric section view and isometric exploded view, respectively, although not eveiy component shown in Fig. 2E, e.g., port unit 208, has been separately exploded or shown in Fig. 2F. In addition to the components shown in Fig. 2A, Fig. 2E also depicts removable sample aliquot unit (SAU) 2,12, which is housed within plunger 2,02 and underneath removable cap 210. SAO 212 may be removably inserted into aliquot port 248 in plunger 202 and filter housing 228, and be in fluid communication with sample collection volume (SCV) 230 via aliquot port 248. SAU 212 may be connected with aliquot port 248 via a press fit, low-strength adhesive, or other mechanism which may allow SAU 212 to be held in place during normal operation of SCU 200, but which allows for an operator to remove SAU212 from SCU 200 without undue exertion. SAU 212 may include SAU plunger 246, which may be used to draw material into SAU 2, 12 or to expel material out of SAU 212. SCV 230 may be generally defined as the volume bounded by the interior surface of main body 204, the bottom surface of filter housing 228, and the top surface of base 206. The bottom surface of filter housing 228 may be defined by filter 226, which may be a micropore filter configured to allow gaseous flow between SCV 2,30 and the ambient environment. Filter 226 may be selected to allow gaseous flow but prevent most liquid flow, such as flow of a biological sample. Filter 226 may be, for example, a 0.2 micron filter. In general, SCV 230 may refer to the volume which is used to capture a desired biological sample within SCU 200.

[0062] Plunger 202 may be designed to be able to slide, translate, or otherwise move relative to main body 204. For example, plunger 202 may be constructed with female threaded interface 240 on the inside, and main body 204 may be constructed with a matching male threaded interface. By rotating plunger 202 with respect to main body 204, plunger 202 may be screwed into or out of main body 204, i.e., translated with respect to main body 2,04. The use of a threaded interface allows the amount of translation to be easily controlled by an operator. Finer pitch threads may allow for a greater degree of control and less effort, but may require a greater number of rotations, whereas coarser pitch threads may require fe wer rotations but may not support, fine control of the translation distance. A threaded interface such as that shown in Figs. 2A-N may also provide an inherent locking mechanism which prevents undesired translation of plunger 202 with respect to main body 204; coarser pitch threads may reduce or eliminate the effectiveness of such a locking mechanism.

[0063] Other mechanisms may be used as well. For example, a ratchet mechanism may be used in place of a threaded mechanism, or to augment a threaded mechanism. In some implementations, plunger 202 may feature barbs, detents, or other ratcheting mechanisms on a surface, and main body 204 may feature a matching set of ratcheting mechanisms on a mating surface. In such implementations, no threaded interface may be used and an operator may simply compress plunger 202 into main body 204 as would be done with a syringe plunger. The compression force used may be sufficient to advance the ratcheting mechanism past one or more stops. The ratchet may prevent plunger 202 from withdrawing from main body 204 once plunger 202 is advanced. In some implementations, a rotational ratchet mechanism may be used in conjunction with a threaded interface to help prevent withdrawal of plunger 202 from main body 204 after plunger 202 has been advanced into main body 204.

[0064] Plunger 202 may be manufactured as a single piece, or may be manufactured from several pieces which are then connected together. For example, plunger 202 as shown in Fig. 2E includes two separate pieces which are connected together to form plunger 202. For example, the outer surface of plunger 202, which may include textured grip surface 256 to allow operators to easily grasp and rotate plunger 202 with respect to main body 204 and base 206 and may provide a portion of threaded interface 240, may be provided by outer portion 202'. Inner portion 202" may provide features for sealing to the interior surface of main body 204 or for mounting other components, such as filter housing 228, which provide such functionality. Inner portion 202" may also provide features for interfacing with SAU 212, such as aliquot port 248, which allows for SAU 212 to be fluidly connected with SCV 230. Outer portion 202' and inner portion 202" may be joined together, for example, via bonded joint 202'". Bonded joint 202"' may be formed using adhesives or a welding process, such as spin welding. In some implementations, bonded joint 202"' may be replaced with a mechanical joint, such as a threaded interface or snap-fit interface. [0065] Filter housing 228 may be connected with plunger 202 and used to provide a sliding seal interface between plunger 202 and main body 204. Filter housing 228 may, for example, provide all or a portion of an o-ring gland for plunger o-ring 244, which may provide a seal between plunger 202 and main body 204. Filter housing 228 may also include passages which allow gas trapped within SCV 30 to be released when plunger 202 is advanced within main body 204. As mentioned above, filter 226 may be connected to the underside of filter housing 228 to allow gas to exit SCV 230 and to prevent collected liquid or solid sample material from exiting SCV 230.

[0066] SCU 200 may also include main body 204, which may be a single piece or multi- piece component. For example, main body 204 may be made from a clear material to allow for visual verification of the quantity of collected biological sample, and to allow for an operator to visually evaluate the degree of homogenization which is present within a collected sample. Main body 204 may include features which interface with features on plunger 202 and base 206. For example, main body 204 as shown in Fig. 2F includes a male threaded feature for interfacing with a corresponding female threaded feature on plunger 202. Main body 204 as shown in Fig. 2F also includes key 262, which interfaces with keyway 264 on base 206 and prevents rotation of main body 204 with respect to base 206 when plunger 202 is rotated.

[0067] Main body 204 may also be connected with base 206 via a sliding interface. For example, in Fig. 2E, main body 204 may slide with respect to base 206 along the center line of main body 204. Homogenizer plate 220 may be connected with base 206 via support shaft 224 such that homogenizer plate 220 stays fixed relative to base 206 when base 206 is translated relative to main body 204. Support shaft 224 may pass through the bottom of main body 204 via shaft opening 266 in the bottom of main body 204; shaft o-ring 238 may form a seal between support shaft 224 and main body 204. Shaft o-ring cover 268 may secure shaft o-ring 2,38 to the underside of main body 2,04. Spring 232 may be housed between the bottom of base 206 and the underside of main body 204, and be configured to force base 206 and main body 204 apart.

[0068] As noted above, homogenizer plate 220 may be supported within SCV 230 by support shaft 224, which may be connected at an opposite end to base 206. Shaft o-ring 238 may allow for relative sliding motion between support shaft 224 and main body 2,04 while preventing biological sample materials in SCV 230 from freely leaking through the sliding interface between support shaft 224 and main body 204. SCV 200 may also feature one or more openings 222 through homogenizer plate 220. As shown, homogenizer plate 22,0 has two openings 222, although other configurations of openings may be used, including non- round openings and differently-sized openings. Other types of homogenizer plates 220 may be used depending on the nature of the sample to be collected. For example, if an SCU is to be used for collecting stool samples, the homogenizer plate may include a large number of larger-aperture openings to allow for the sample to be homogenized without clogging the openings through homogenizer plate.

[0069] As noted above, SCU 200 may also include port unit 208, which may be inserted through port 234. As discussed previously with respect to Figs. 2B-2D, port unit 2,08 may include suction port 214 and collection port 216, both of which may provide for fluid flow through port 234, although in opposite directions. Suction port 214 and collection port 216 may each be equipped with barbed or other nipples to facilitate easy connection to a variety of different sizes of rubber tubing. Other suitable fittings or interfaces may be used as well, including quick-release fittings or threaded fittings. Port unit 208 may include port clips 236, which may be configured to clip around main body 204 and secure port unit 208 to SCU 200. Other techniques of securing port unit 2,08 to main body 204 may be used as well, such as a press fit within port 234, a clamshell clamp latching around main body 204, or a threaded interface at port 234, for example. Port unit 208 may be removed prior to placing SCU 200 in a pneumatic tube system is such a system is in use.

[0070] Figs. 2G-2N depict cross-sectional side views of SCU 200 during various stages of use. Most of the components discussed previously are also indicated in Figs. 2G-2N, although some of the callouts have been omitted for clarity.

[0071] Fig. 2G, for example, depicts SCU 200 prior to sample collection. Port unit 208 has been inserted through port 234 (not shown), either by an operator or during manufacture, i.e., SCU 200 may be delivered to a healthcare provider fully assembled. Protective caps (not shown) may seal off suction port 214 and collection port 216 and prevent contamination of SCU 200, but these caps may be removed prior to use. [0072] During use, SCU 200 may be connected to a suction source using suction port 214. Such a connection may be made, for example, using flexible tubing which connects to suction port 214 and to a facility vacuum source. Collection port 216 may be connected to a sample source, such as an endotracheal tube connected to a mechanical ventilator and installed in a patient's trachea, via a second flexible tube. More direct collection of a sample may be effected by locating the inlet port of the fluid flow passage including the second flexible tube in closer proximity to the patient's airways or lungs, such as may occur in a bronchoalveolar lavage process. After both suction port 214 and collection port 216 are connected to their respective sources, the vacuum source may be engaged, and gas (including fluids and entrained solids from the sample source) may be drawn into SCV 230. The gas may then flow out of SCV 230 via interior suction port 242 , through port unit 208, and out of port unit 208 via suction port 214. Due to interior suction port 242's location being offset from main body 2,04' s internal wall by riser 260, most fluids or solids entrained with the gas will, due to their mass, gravitationaily separate from the gas flow, collect on the surfaces defining SCV 230, and, in general, not flow out of interior vacuum port 242. Of course, if sample collection is conducted for a sufficiently long period of time, the level of liquids and/or solids in SCV 230 may rise to a level that causes such materials to be introduced into interior suction port 242 despite the offset of interior suction port 242 from the interior walls of main body 204.

[0073] After desired sample material is collected in SCV 230, the supply of vacuum through suction port 214 may be terminated. After the vacuum supply is terminated, port unit 208 may be removed from main body 204 by grasping SCU 2,00 and pulling on handle 218 of port unit 208. In some implementations, port unit 208 may be removed from main body 204 without first terminating the vacuum supply. Fig. 2H depicts SCU 200 after port, unit 208 has been removed.

[0074] Fig. 2H depicts SCU 200 after sample collection has occurred and port unit 208 has been removed. As can be seen, a volume of sample material has been collected within SCV 230, as indicated by the area with irregular-shaped particles/clots entrained within. To assist in understanding, the portion of SCV 230 which has been filled with sample material is indicated by 230'; the portion of SCV 230 which has not been filled is indicated by 2,30". The sample material and unfilled portion of SCV 230 are not shown in the remaining Figures in this way. It is to be understood that the amount of collected sample material may be less than thai shown, and may not completely, or even mostly, fill SCV 230 prior to any gas bleeding of SCV 230 (described later in this paper). For example, portions of collected sputum may coat portions of the interior surface of main body 204, homogenizer plate 2,20, and filter 226, although the inner volume of SCV 230 may be largely empty. The collected sample may include liquids, entrained gases, solids, and semi-solid materials,

[0075] Fig. 21 depicts SCU 200 after excess gas, e.g., air, in SCV 230 has been bled out. An operator of SCU 200 may rotate plunger 202 relative to main body 204 and base 206. Such rotation may, due to threaded interface. 240, cause plunger 202, filter housing 228, and filter 226 to advance into main body 204 in a manner which forces any free gas in SCV30 through filter 226 and through vent hole 270. In this manner, excess gas in SCV30 may be bled off, which reduces the likelihood that such gas may become entrapped within the sample material when homogenization is performed. Filter 226 may of sufficient fineness that gas may permeate through filter 226 while filter 226 is, at the same time, substantially impermeable to the collected biological sample. When plunger 202 has been sufficiently advanced that all, or substantially all, free gas has been bled from SCV 230, and that plunger o-ring 244 has passed port 234, homogenization may be performed. The inner edge of port 234 may be smoothed to allow plunger o-ring 244 to pass over port 234 without damaging plunger o-ring 244. In this example, there is sufficient sample material that plunger o-ring 244 just barely passes port 234.

[0076] After port unit 208 has been removed, SCV 230 may be reduced in volume by translating plunger 202 closer to base 206. Such translation serves several purposes. For example, plunger o-ring 244, which may provide a seal between the in terior surface of main body 202 and filter housing 2,2,8, may be moved past port 234. In this manner, port 234 maybe sealed off from fluidic communication with SCV 230, which prevents collected biological sample material from escaping through relatively large-diameter port 234. In some implementations, port 234 may be additionally or alternatively sealed or partially sealed using some other mechanism, such as a septum or a rotating C-shaped collar. Another result of such translation is that gases which are present in SCV 230 may be forced out of SCV230 through filter 226. SCV 230 may be decreased in size via translation of plunger 202 until all or nearly all of the free gas in SCV 230 has been evacuated, leaving a biological sample which is substantially composed of liquids, solids, or both. In the implementation shown in Fig. 21, the translation is effected by rotating plunger relative to main body 204 and base 206. A screw advance translation mechanism such as that shown allows plunger 202 to be advanced in a gradual manner and with minimal effort. Other translation techniques may be implemented as well, however, such as a plunger configured to translate in response to application of an axial force rather than a torsional moment.

[0077] Fig. 2J depicts SCU 200 after SCV 230 has been reduced in volume by bleeding the free gas from SCV 230. After bleeding has been completed, homogenizer plate 220 may be used to mix the collected biological sample and render it more homogenous. Such homogenization may be effected by reciprocating homogenizer plate 220 with respect to SCV 230. As homogenizer plate 220 reciprocates within SCV 230, the biological sample contained within SCV 230 is forced past homogenizer plate 220 and into the portion of SCV 230 which homogenizer plate 220 just occupied. The biological sample may flow past the perimeter of homogenizer plate 220 or through openings 222 in homogenizer plate 220. In some implementations, an o-ring or other seal may prevent flow past the perimeter of homogenizer plate 220 and all flow past homogenizer plate 220 may instead be through openings 222 in homogenizer plate 220. Because SCV 230 is largely free of gas, the entrainment of gas in the biological sample during homogenization is significantly reduced, which promotes accurate aliquoting downstream.

[0078] Homogenizer plate 220 may be reciprocated within SCV 230 by compressing plunger 202 and main body 204 against base 206. Fig. 2K shows SCU 200 during homogenization, although at a further state of compression than shown in Fig. 2J. The effect of

homogenization is represented in Fig. 2J by the smaller particle/clot size present in the biological sample beneath homogenizer plate 220 as compared with the particle/clot size in the biological sample above homogenizer plate 2,2,0, although the degree of homogenization achieved during each stroke of homogenizer plate 220 may vary. Spring 232, which is compressed between a lo wer surface of base 206 and the bottom of main body 206, may resist such compression and act to restore SCU 200 to its uncompressed state. By placing SCU 200 such that base 206 rests on a fiat surface, an operator may simply push down on plunger 202 to effect a homogenization stroke, and spring 232 may then act to restore SCU 200 to its uncompressed state, effecting the return homogenization stroke. Such compression may also be performed by an operator grasping base 206 and plunger 2,02/main body 204 and compressing them between both hands. In some implementations, spring 232 may not be used, and an operator may need to apply both compressive and tensile loads to SCU 200. [0079] Homogenizer plate 220 may be reciprocated within SCV 230 multiple times to ensure a desired degree of homogenization. For example, standard usage of SCU 200 may, in some implementations, involve reciprocating homogenizer plate 220 within SCV 230 at least once to ensure a consistent degree of homogenization across samples collected using SCU 230s. In some implementations, SCU 200 may be reciprocated within SCV 230 a maximum of 20 times. Some SCU implementations may also feature a mechanism for limiting the number of reciprocations, such as a ratchet mechanism. Such a mechanism may be used to prevent over-homogenization and ensure that samples are all mixed to approximately the same degree. For example, if a bedside operator reciprocates the homogenizer plate 5 times, a lab technician may decide that the homogenizer should be further reciprocated, and perform additional reciprocation limited to, for example, 20 total reciprocations, i.e., 15 additional reciprocations. A ratchet mechanism may limit the number of additional reciprocations such that the total number of reciprocations is the same from SCU to SCU. Other implementations of SCUs may feature differing numbers of reciprocations. The number of reciprocations may be dependent on the physical arrangement of components within the SCU, the testing technique to be used on the collected sample, the nature of the collected sample, or other factors.

[0080] After the biological sample has been homogenized, a portion of the biological sample may be extracted from SCU 200 for laboratory analysis. Such extraction may occur, for example, using SAU 212. In such a technique, cap 210, if present, is first removed from plunger 202, as shown in Fig. 2L. In some implementations, aliquot plunger 246 may then be drawn towards the back end of S AU 212 to draw sample material into SAU 2, 12. After a sufficient amount of biological sample has been drawn into SAU 212, the drawing of aliquot plunger 212 towards the back end of SAU 212 may cease and SAU 212 may be removed from aliquot port 248 in plunger 202 or filter housing 228. In some implementations, SAU 212 may not be contained within plunger 202, but may be introduced into the interior area of plunger 202 after cap 210 is removed or, for a plunger 202 without cap 210, prior to sample extraction. Aliquot port, 248 may equipped with a septum to provide a seal between SCV 230 and the ambient environment when SAU 212 is not installed in aliquot port 248.

[0081] In some implementations, a metering system may be employed which is part of SAU 212 itself. A positive stop in SAU 212 may prevent SAU 212 from being filled beyond the desired level. In such implementations, plunger 202 may be advanced towards base 206 until SAU 212 is filled to capacity. At this point, further advancement of plunger 202 may not be possible due to the generally incompressible nature of the biological sample. In some cases, further advancement of plunger 202 may be possible if SAU 212 is forced out of aliquot port 248 due to the pressure exerted on the biological sample. In some alternative

implementations, aliquot plunger 246 may be withdrawn from SAU 212 until aliquot plunger 246 bottoms out on a positive stop which limits the total amount of biological sample which may be drawn into SAU 212.

[0082] Some implementations of SCU 200 may also allow for biological sample collection from the interior of SCV 230 using instruments other than SAU 212. For example, a pipette or loop may be inserted through aliquot port 248 instead of SAU 212. Alternatively, a portion of th e biological sample may be extruded through aliquot port 248 and into a well inside of plunger 202. Accessing the biological sample using a loop or pipette may be easier in the well of plunger 202 than through aliquot port 248. Cap 210 may be used to protect the purity of the biological sample after the biological sample is exposed to the ambient environment via aliquot port 248.

[0083] In some implementations, such as that shown in Fig. 2-N, SAU 212 may be filled by forcing biological sample material from SCV 230 into SAU 212 by increasing the static pressure on the biological sample material within SCV 230. This may be effected, for example, by applying further torque to plunger 202, which causes further advancement of plunger 202 into main body 204, further decreasing the size of SCV 230 and forcing collected biological sample material into SAU 212 through aliquot port 248. Aliquot plunger 246 may be displaced by the sample material forced into SAU 212.

[0084] In some implementations, such as that shown in Figs. 2A- , SCU 200 may feature a metering system which may allow for preset amounts of biological sample to be transferred to SAU 212. Referring to Fig. 2A, plunger 202 may have a series of markings 250 about the outer circumference near where main body 204 mates with plunger 202. Reference line 252 on main body 204 may line up with one of the markings 250 on plunger 202. The distance between markings 250 may correspond to a unit of volumetric displacement of SCV 230, e.g., 0.1 ml, which may be effected by rotating plunger 202 through the marking separation distance. For example, to transfer 0.5 ml of the biological sample to SAU 212, plunger 202 may be rotated (in the direction which corresponds with further compression of SCV 230) with respect to main body 204 such that reference line 252 on main body 204 shifts about the circumference of plunger 202 by a distance of five markings 250, In some implementations, markings 250 may be on a ring or collar which is rotatably attached to plunger 202. In such implementations, the ring or collar may be rotated to align a "zero" mark 250 with reference line 252 on main body 202, which may allow for more precise metering since situations in which the reference line initially straddles two marks 2,50 may be avoided.

[0085] In some implementations, where the biological sample material is collected using SAU 212, SAU 212 may be removed once the desired amount of sample has been retrieved, as shown in Fig. 2N. If desired, a different SAU 212 may be installed into aliquot port 248 to collect a further sample. Such additional samples may be collected until no further collectible sample remains within SCU 200. In some implementations, plunger 202 may be removed from SCU 200 after homogenization to open SCV 230 to the ambient environment and allow for direct access to the homogenized sample. For example, a loop or pipette may be used to directly withdraw sample material from the homogenized sample. The remaining components of SCU 200 may then be disposed of using normal handling procedures for biologically-contaminated items. In some implementations, SCU 200, or portions thereof, may be re-usable, for example, after autoclaving. In some other implementations, SCU 200 may not be re-usable and re-use of SCU 200 may introduce a risk of cross-sample contamination. Other SCU designs may include similar features.

[0086] SCU 200 may be made from a variety of materials. For example, SCU 200 may be made from any of a variety of plastics, and different components of SCU 200 may be made from different plastics. Some components, such as support shaft 22,4 and spring 232, may be made from metals, such as steel. While the transparency/opacity of most of the materials used may be a matter of design choice, it may be desirable for some components, such as main body 204, to be transparent or partially transparent to allow sample

collection/preparation personnel to easily observe the sample within SCU 200.

[0087] Some implementations of SCUs may, in general, be configured for hand-held use, i.e., some SCUs may be compact enough to be used or operated while being held in the hand or hands. It is to be understood that while many objects are of sufficiently small size to be described as being capable of being held by a human hand or hands, not all such objects may^¬ be described as "handheld" because they are not designed for ease of carrying by hand. For example, most web cameras are small enough to be held by hand, but it would not be reasonable to describe most web cameras as "handheld" cameras since they are typically designed to clip onto a monitor or stand on a base structure. In contrast, it would be entirely reasonable to describe a compact point-and-shoot digital camera as a "handheld'^'' camera, since it is designed to be held in a user's hand while being operated. As mentioned elsewhere in this document, SCUs may also be configured to be compatible with pneumatic transport systems, which may place a further limit on their size and weight.

[0088] Some implementations of SCUs may also be configured to be easily portable, i.e., requiring no special carrying container or equipment for transport from one location to another. For example, an SCU may be lightweight, easily graspable in a human hand, and capable of withstanding minor mechanical insults, such as being dropped from the height of a hospital bed, without failure. Some implementations of an SCU may be easily manipulated by human hands in order to facilitate, making connections to suction sources or sample collection sources. Some implementations of an SCU may require no external electrical or other power to perform homogenization, and may be entirely operated, after sample collection has occurred, by human effort applied directly to the SCU.

[0089] SCU 200 may also include various substances which are designed to interact with a collected biological sample. For example, chemical reagents which may help stabilize and preserve a collected sample may be pre-loaded into SCU 200 before use. Such pre-loading may occur in a medical facility where SCU 200 is being used or earlier, such as at location in the manufacturing chain. Other examples of substances which may be loaded into SCU 200 prior to sample collection include reagents which indicate the presence of a biological organism or a particular chemical or molecule, substances which promote bacterial growth, and substances which may dilute or thin out the collected sample for ease of collection or homogenization.

[0090] SCU 200 may also be designed to be retained, with a collected sample, for a specified period of time. SCU 200 may include various chemicals or other substances which act to preserve collected sample material for a period of several hours or days to allow for delays between collection and testing.

[0091] Various techniques may be used to indicate whether or not a biological sample has undergone homogenization within SCU 200 or other implementations of an SCU, as shown in Figs. 3A-3D. In some implementations, such as shown in Fig. 3A, tear-off tabs 304 may be used which are part of patient label 302 for the SCU. The "Not Mixed" tab may be torn off after a sample is collected but has not yet been mixed. The "Mixed" tab may be torn off after the sample has been mixed. In another example, such as shown in Fig. 3B, label 306 may span across portions of the SCU which move relative to each other during

homogenization, such as main body 204 and base 206 of SCU 200. Label 306 may require removal before homogenization may be performed, or may be automatically torn as a result of performing homogenization. In another example, as shown in Fig. 3C, break-away tab 308, with respect to SCU 200, may prevent movement of main body 204 relative to base 206 until tab 308 is broken and removed. Another example, as shown in Fig. 3D, may use internal bayonet-style track 310 and a pin which travels in track 310. While the pin is in the portion of track 310 which travels in a circumferential direction, track 310 prevents axial motion of the pin with respect to track 310 and thereby prevents, with respect to an implementation similar to SC U 200, reciprocation of homogenize!' plate 220 with respect to base 206. To allow for homogenization, base 206 may be rotated with respect to main body 204 until the pin is in the portion of track 310 which travels in the axial direction and thereby permits reciprocation of homogenizer plate 220 with respect to base 206.

[0092] While one technique for using an SCU has been outlined above with respect to Figs. 2A-20, Fig. 4 provides a high-level flow diagram of an implementation of sample collection technique 400 using an SCU configured for collection of sputum samples. Initially, a sample port of the SCU may be connected to a sample collection source (402), such as a tube used to remove air and liquid from a patient's lungs, e.g. , a ventilator tube. A suction port of the SCU may be connected to a suction source (404), such as a facility vacuum source or a ventilator. After the above connections have been made, the suction, if not already active, may be engaged and biological sample material collected within the SCU (406). After a desired amount of biological sample material has been collected within the SCU (408 ), suction may be disengaged (410) and a port assembly including the sample port and the suction port, may be removed (412). The aperture which allowed the port unit to protrude into the SCU may be then be sealed (414) and the plunger of the SCU depressed to de-gas or de-air the SCU SCV (416). In some implementations, both of these steps may be performed by a single, continuous action. After de-airing the SCU, the collected biological sample may^¬ be homogenized by compressing the SCU (418); the compression (and any corresponding decompressions) may be repeated a desired number of times to ensure a desired degree of homogenization is achieved (420). After homogenization is completed, an aliquot may be filled to a desired level (424). In cases where the amount of aliquot fill is intended to be variable, a metering setting may be set or taken into account (422) prior to filling the aliquot. After the aliquot is filled to the desired level, the aliquot may be removed (426). If additional samples are desired after removal of the aliquot, a new aliquot may be installed in the SCU and 422-426 may be repeated as desired. In some implementations, additional sample material may be retrieved from the aliquot port using a pipette, loop, or other instrument (428). When sample collection is complete, the SCU may be discarded as appropriate for a biological sample container (430).

[0093] In another implementation, the homogenizer plate may remain stationary with respect to the main body, and may even be an integral portion of the main body. In such an implementation, the sample is reciprocated between one side of the homogenizer plate and the other by translation of the base (or of the plunger).

[0094] Fig. 5 A depicts an isometric view of one implementation of such a design. SCU 500 may include plunger 502, main body 504, and base 506. SCU 500 may also include SAU 512, which may contain aliquot plunger 546. Fig. 5B depicts an isometric section view of SCU 500. Additionally visible in Fig. 5B are upper plug 572, lower plug 574, and homogenizer baffle 220, which may be an integral portion of main body 504. Upper plug 572 and lower plug 574 may be made from an elastomeric material, and may be affixed to plunger 502 and base 506, respectively. Fig. 5C shows SCU 500 in an isometric exploded view.

[0095] Fig. 5D depicts SCU 500 just prior to sample collection. In preparation for sample collection, plunger 502 is not installed. Instead, port unit 508, which is modeled after a Lukens' trap cap in this implementation, is installed over the top of main body 504. Port unit 508 includes suction port 14 and collection port 516. Suction port 514 may be connected to a vacuum source, such as a ventilator suction port or a facility vacuum source, and collection port 516 may be connected to a sample source, such as a tube in fluidic communication with a patient's airways.

[0096] Fig. 5E depicts SCU 500 after a biological sample has been collected. After the sample has been collected, port unit 508 may be removed, as shown in Fig. 5F, and replaced with plunger 502, as shown in Fig. 5F. In some implementations, such as that shown, plunger 502 is inserted into main body 504 without SAU 512 present, which allows excess air in the SCV to evacuate SCU 500 via aliquot port 548 when plunger 502 is inserted into main body 54 until upper plug 572 contacts the biological specimen, such as is shown in Fig. 5H. In some implementations, SAU 512 may be installed in plunger 502 prior to inserting plunger 502 into main body 504. In such implementations, other techniques for bleeding trapped has may be used, such as a filter or valve through upper plug 572. Ratchet features 576 on plunger 502 and main body 504 may prevent plunger 502 from being pulled out of SCU 500 once inserted.

[0097] Fig. 51 depicts section view of SCU 500 after SAU 512 has been inserted, effectively sealing the collected biological sample inside of SCU 500. Figs. 5J-5M depict SCU 500 during various stages of homogenization. An operator may grab plunger 502 and outer portion 578 of main body 504 and reciprocate them relative to each other. While main body 504 is substantially enclosed within the outer bounds of plunger 502 and base 506, outer portion 578 protrudes through base 506 to allow main body 504 to be gripped externally. Base 506 may have slots to allow main body 504 protrude through base 506 and to allow the protruding portions to slide back and forth with respect to base 506. As main body 504 is reciprocated with respect to plunger 502, base 506, upper plug 572, and lower plug 574, homogenizer baffle 520 forces the collected biological sample through opening 522, effectively causing the collected biological sample to travel back and forth between one side of homogenizer baffle 520 to the other side of homogenizer baffle 520.

[0098] After homogenization is complete, SAU 512 may be filled by further compressing plunger 502 with respect to base 506 to inject homogenized sample material into SAU 512 as shown in Fig. 5N, or, in some implementations, withdrawing aliquot plunger 546 from SAU 512 to suck homogenized sample material out of SCU 500.

[0099] After a desired amount of homogenized sample has been transferred to SAU 512, SAU 512 may be removed from SCU 500, as shown in Fig. 50.

[00100] It is to be understood that the various components discussed within this paper may, in some implementations, be constructed differently. For example, in some

implementations, components which are shown as a single part may, absent any indication to the contrary, be made from multiple parts which may then be assembled into an assembly which provides functionality similar to that provided by the single part. Conversely, components which are shown or presented as consisting of multiple parts may, absent any indication to the contrary, be made as a single, integrated part in some implementations.

[00101] Although the foregoing invention has been described in some detail for purposes of clarity of understanding, it will be apparent that certain changes and

modifications may be practiced within the scope of the invention. It should be noted that there are many alternative ways of implementing both the processes and apparatuses of the present invention. Accordingly, the present implementations are to be considered as illustrative and not restrictive, and the invention is not to be limited to the details given herein.

[00102] It will be further understood that unless features in any of the particular preferred implementations are expressly identified as incompatible with one another or the surrounding context implies that they are mutually exclusive and not readily combinable in a

complementary and/or supportive sense, the totality of this disclosure contemplates and envisions that specific features of those complementary implementations can be selectively combined to provide one or more comprehensive, but slightly different, technical solutions. It will therefore be further appreciated that the above description has been given by way of example only and that modifications in detail may be made within the scope of the invention.

Claims

What is claimed is:

1. A biological sample collection device comprising:

a handheld sample collection unit (SCU) including an internal sample collection volume; and

a mechanical homogenizer located within the sample collection volume.

2. The biological sample collection device of claim 1, wherein the biological sample collection device is configured to allow air trapped in the sample collection volume to escape while fluids or solids in the sample collection volume are retained.

3. The biological sample collection device of claim 1, further comprising a sample removal device with a second sample collection volume, the sample removal device configured to:

be removably installed in the biological sample collection device,

fluidly communicate with the sample collection volume when installed in the biological sample collection device to allow at least a portion of a sample collected with the sample collection device to be transferred into the second sample collection volume, and prevent the sample collected within the biological sample collection volume from escaping into the ambient environment when the sample collected with the sample collection device is transferred into the second sample collection volume.

4. The biological sample collection device of claim 3, wherein the sample removal device is configured to accept no more than a pre-set amount of the sample.

5. The biological sample collection device of claim 1, wherein the SCU is configured to allow the mechanical homogenizer and the sample collection volume to translate relative to each other.

6. The biological sample collection device of claim 1, wherein the SCU is configured to allow the mechanical homogenizer and the sample collection volume to reciprocate relative to each other.

7. The biological sample collection device of claim 5, wherein the SCU is further configured to allow the mechanical homogenizer and the sample collection volume to rotate about an axis parallel to the direction of translation and relative to each other.

8. The biological sample collection device of claim 1, wherein the biological sample collection device is a single-use, disposable device.

9. The biological sample collection device of claim 5, wherein the mechanical homogenizer comprises a flat plate with:

an outer edge substantially proximate to an interior surface of the sample collection volume along the perimeter of the flat plate, and

one or more openings providing fluidic communication between opposite sides of the flat plate.

10. The biological sample collection device of claim 9, wherein the SCU further comprises:

a main body; and

a plunger, wherein:

the plunger includes a central portion which is configured to translate within the main body,

the sample collection volume is substantially defined by the central portion and by interior surfaces of the main body, and

the sample collection volume decreases when the central portion is translated into the main body.

1 1. The biological sample collection device of claim 10, wherein the plunger further includes:

an exhaust passage, wherein the exhaust passage fluidly connects the sample collection volume with the ambient environment outside of the SCU; and

a filter configured to permit gas flow through the exhaust passage while substantially preventing liquid flow through the exhaust passage.

12. The biological sample collection device of claim 10, further comprising a base, wherein the base is:

connected with the mechanical homogenizer,

configured to remain stationary with respect to the mechanical homogenizer during reciprocating motion of the mechanical homogenizer and the sample collection volume relative to each other, and

located substantially outside of the main body.

13. The biological sample collection device of claim 12, further comprising a spring configured to bias the base and the flat plate away from the central portion.

14. The biological sample collection device of claim 1, further comprising:

a port assembly, wherein the port assembly includes:

a stem, wherein the stem includes a first end and a second end, a first suction port, wherein the first suction port is configured to be connected to a suction source, a second suction port,

a first sample port, wherein the first sample port is configured to be connected to a sample source,

a second sample port,

a suction passage fluidly connecting the first suction port with the second suction port,

a sample passage fluidly connecting the first sample port with the second sample port, wherein:

the suction passage and the sample passage are separate from each other and both housed within the stem,

the first sample port and the first suction port are both located substantially proximate to the first end of the stem, and

the second sample port and the second suction port are both located substantially proximate to the second end of the stem; and

a port aperture, wherein the port aperture is configured to receive the second end of the stem and permit the second end of the stem to be introduced into the sample collection volume and the second suction port and the second sample port to fluidly communicate with the sample collection volume.

15. The biological sample collection device of claim 1, wherein the sample collection volume contains one or more chemicals selected from the group consisting of chemicals for stabilizing a biological sample, chemicals for preserving the biological sample, chemicals for pre-treating the biological sample, chemicals for promoting bacterial growth in the biological sample, chemicals for diluting the biological sample, and chemicals for indicating the presence of a particular organism or chemical in the biological sample.

16. The biological sample collection device of claim 10, wherein:

the plunger further includes a threaded feature,

the main body includes a mating threaded feature,

rotation of the plunger with respect to the main body in a first direction causes the plunger to translate into the main body, and

rotation of the plunger with respect to the main body in a second direction causes the plunger to translate out of the main body.

17. The biological sample collection device of claim 10, wherein the SCU further comprises:

a sample aliquot unit, the sample aliquot unit in fluidic communication with the sample collection volume, wherein, when substantially all free gas within the sample collection volume has been bled away, rotation of the plunger in a first direction with respect to the main body forces sample material within the sample collection volume into the sample aliquot unit.

18. The biological sample collection device of claim 17, wherein:

the plunger includes reference marks spaced about at least a portion of an external edge of the plunger in the vicinity of the main body,

the main body includes a reference line, and

rotation of the plunger with respect to the main body by a distance corresponding with the distance between two of the reference marks forces a first amount of sample material into the sample aliquot unit when all free gas in the sample collection volume has been bled off.

19. The biological sample collection device of claim 1, wherein the SCU is configured to fit within a cylindrical volume having a diameter of approximately 1.75 inches and a length of 5.5 inches.

20. The biological sample collection device of claim 5, wherein the SCU comprises: a substantially tubular main body, wherein:

a region of the main body forms a baffle within, and oriented substantially perpendicular to a major axis of, the main body, and

the main body includes a first inner wall and a second inner wall, the first inner wall separated from the second inner wall by the baffle;

a plunger, the plunger including an exterior housing and an upper plug; and a base, the base including a lower plug, wherein:

the lower plug is in sliding contact with a first inner wall of the main body, and

the upper plug is inserted into the main body such that the upper plug is in sliding contact with a second inner wall of the main body.

21. The biological sample collection device of claim 20, wherein, when the upper plug is inserted into the main body:

the base and plunger are configured to:

allow for engagement of the plunger with the base,

allow for further insertion of the upper plug into the main body while maintaining the engagement of the plunger with the base, and

prevent retraction of the upper plug from the main body;

the first inner wall, the second inner wall, a first surface of the upper plug facing the baffle, and a second surface of the lower plug facing the baffle substantially define a sample collection volume; and

the main body is configured to slide relative to the upper plug and the lower plug, thereby translating the baffle within the sample collection volume.

22. The biological sample collection device of claim 20, wherein main body is substantially radially symmetric, the first inner wall and the second inner wall have matching diameters, and the baffle is formed by a narrowing of the main body to a diameter substantially smaller than the matching diameters of the first inner wall and the second inner wall.

23. A method comprising:

collecting a biological sample within a hand-held sample collection unit (SCU); and

homogenizing the biological sample by moving a first portion of the SCU with respect to a second portion of the SCU.

24. The method of claim 23, wherein the homogenizing is performed by reciprocating the first portion of the SCU with respect to the second portion of the SCU multiple times.

25. The method of claim 23, wherein the homogenizing is performed without opening the SCU.

26. The method of claim 23, wherein:

the first portion includes a plunger and a main body,

the second portion includes a base and a homogenizer plate,

the homogenizing is performed by translating the plunger and the main body with respect to the base and the homogenizer plate.

27. The method of claim 26, wherein the translating is performed multiple times.