Patent Grant
12083234
Embodiments described herein relate generally to the parenteral procurement of bodily-fluid samples, and more particularly to systems and methods for parenterally-procuring bodily-fluid samples with reduced contamination from microbes or other contaminants exterior to the bodily-fluid source that can potentially distort the results of diagnostic testing in a healthcare setting.
Health care practitioners routinely perform various types of microbial as well as other broad diagnostic tests on patients using parenterally-obtained bodily-fluids. As advanced diagnostic technologies evolve and improve, the speed and value of information that can be provided to clinicians continues to improve. As such, ensuring that the bodily-fluid sample to be analyzed is collected in a fashion that maintains specimen integrity similarly ensures that analytical diagnostic results are representative of the in vivo conditions of a patient. Examples of diagnostic technologies that are reliant on high quality, non-contaminated bodily-fluid samples include but are not limited to microbial detection, molecular diagnostics, genetic sequencing (e.g., DNA, RNA), and the like. When biological matter, cells external to the intended source for sample procurement, and/or other external contaminants are inadvertently included in the bodily-fluid sample that is to be analyzed, the opportunity for an adulterated specimen driving a potentially inaccurate patient diagnosis may occur.
In some instances, patient samples (e.g., bodily-fluids) are tested for the presence of one or more potentially undesirable microbes, such as bacteria, fungi, or yeast (e.g., Candida). Microbial testing may include incubating patient samples in one or more sterile and/or non-sterile vessels containing culture media or other types of solutions that are conducive to microbial growth and/or other real-time diagnostic approaches including molecular polymerase chain reaction-based (PCR-based) and/or other technologies (e.g. magnetic resonance, automated microscopy, spatial clone isolation, etc.) used to rapidly detect and identify organisms. Generally, when microbes tested for are present in the patient sample, the microbes flourish over time in the culture medium. These organisms may also be identified by other advanced diagnostic testing technologies (e.g., molecular diagnostics, PCR, genetic testing/sequencing, magnetic resonance, automated microscopy, spatial clone isolation, etc.). In the case of employing a culture medium, after an amount of time (e.g., a few hours to several days—which can be longer or shorter depending on the diagnostic technology employed), organism growth can be detected by automated, continuous monitoring. For example, in some instances, such automated monitoring can detect carbon dioxide produced by organism growth. The presence of microbes in the culture medium (as indicated by observation of carbon dioxide) and/or via other detection methods suggests the presence of the same microbes in the patient sample which, in turn, suggests the presence of the same microbes in the bodily-fluid of the patient from which the sample was obtained. Accordingly, when microbes are determined to be present in the culture medium (or more generally in the sample used for testing), the patient may be prescribed one or more antibiotics or other treatments specifically designed to treat or otherwise remove the undesired microbes from the patient.
Generally, patient bodily-fluid samples are collected in various settings and are then transported to a laboratory-type environment for processing and analysis. For example, the settings for collecting the patient sample(s) could include an outpatient clinic, a hospital (including emergency department, intensive care unit (ICU), medical/surgical floor, or the like) or a commercial setting (including a drugstore or any other commercial enterprise that assists with collection of bodily-fluid sample(s)). In all settings, typically, protocols are developed, implemented, and monitored to ensure the quality of the collection, handling, preparation, transportation, etc. of a patient's bodily-fluid sample(s). Generally, practitioners attempt to ensure the integrity of the patient specimen(s), understanding that if the sample is adulterated and/or contains matter that is not representative of the patient's in vivo condition, a diagnostic error and ensuing inaccurate treatment decision(s) may occur.
In some instances, patient samples, nonetheless, can become contaminated during procurement. For example, some equipment used in phlebotomy procedures can include multiple fluidic interfaces (e.g., patient to needle, peripheral IV to catheter, needle/tubing to sample vessels, etc.) that can each introduce points of potential contamination. Additionally, the equipment used to procure, transfer, transport, and/or otherwise contain a patient sample are typically connected and/or otherwise placed in fluid communication via manual intervention (e.g., a doctor, phlebotomist, nurse, etc. handles and/or manipulates the equipment). Since the interfaces of the equipment are not consistently preassembled and/or sterilized as a single fluidically coupled system, external contaminants (e.g., microbes, dermally-residing organisms, cells from the patient that are not from the intended source of bodily-fluid to be tested, etc.) can be introduced to the patient sample via multiple sources (e.g. ambient air, contaminants on surfaces of tables and/or counters in patient room, microbes transferred from linens or clothing, skin deposited on collection supplies from a healthcare worker during assembly and/or sample procurement or transfer, cells from another source within the patient, and/or the like). In some instances, the contaminants can lead to a positive microbial and/or other diagnostic test result, thereby falsely indicating the presence of such microbes or other cells and/or other biological matter in vivo. Such inaccurate results are a concern when attempting to diagnose or treat a suspected illness or condition. For example, false positive results from microbial tests may result in the patient being unnecessarily subjected to one or more anti-microbial therapies, which may cause serious side effects to the patient including, for example, death, as well as produce an unnecessary burden and expense to the healthcare system.
As such, a need exists for improved systems and methods for disinfection of specimen container(s) that reduce microbial and/or any other types of contamination associated with the collection of bodily-fluid test samples by, for example, disinfecting equipment and/or fluidic interfaces to ensure the integrity of the patient sample(s) that are collected and analyzed in diagnostic processes to minimize and/or substantially eliminate false positive as well as false negative diagnostic results.
Apparatus and methods for parenterally-procuring bodily-fluid samples with reduced contamination from microbes exterior to the bodily-fluid source and/or other undesirable external contaminants or biological matter are described herein. In some embodiments, an apparatus includes a fluid reservoir, a sterilization member, and a transfer adapter. The fluid reservoir has an inlet surface and is configured to receive a volume of bodily-fluid transferred from a patient. The sterilization member operably couples to the fluid reservoir and defines at least a portion of a substantially sterile environment. The sterilization member is configured to be transitioned between a first configuration, in which the sterilization member obstructs the inlet surface and maintains the inlet surface in the substantially sterile environment, and a second configuration, in which the inlet surface is unobstructed. The transfer adapter is configured to be placed in fluid communication with a portion of a patient. The transfer adapter is configured to move relative to the sterilization member from a first position to a second position. A surface of the transfer adapter is configured to contact the sterilization member as the transfer adapter moves to the second position to transition the sterilization member from the first configuration to the second configuration. The fluid reservoir is placed in fluid communication with the transfer adapter when the transfer adapter is in the second position.
In some embodiments, an apparatus includes a fluid reservoir, a sterilization member, and a transfer adapter. The fluid reservoir has an inlet surface and is configured to receive a volume of bodily-fluid transferred from a patient. The sterilization member operably couples to the fluid reservoir and defines at least a portion of a substantially sterile environment. The sterilization member is configured to be transitioned between a first configuration, in which the sterilization member obstructs the inlet surface and maintains the inlet surface in the substantially sterile environment, and a second configuration, in which the inlet surface is unobstructed. The transfer adapter is configured to be placed in fluid communication with a portion of a patient. The transfer adapter is configured to move relative to the sterilization member from a first position to a second position. A surface of the transfer adapter is configured to contact the sterilization member as the transfer adapter moves to the second position to transition the sterilization member from the first configuration to the second configuration. The fluid reservoir is placed in fluid communication with the transfer adapter when the transfer adapter is in the second position.
In some embodiments, a system for parenterally-procuring bodily-fluid samples with reduced contamination from microbes exterior to the bodily-fluid source includes a sample reservoir, a handle, and an adapter. The handle is configured to be placed in fluid communication with a patient. The handle has a coupler, a fluid reservoir, and an actuator. The fluid reservoir is disposed within the handle and configured to receive a volume of bodily-fluid from the patient. The actuator is configured to be transitioned between a first configuration, in which the coupler is fluidically isolated from the fluid reservoir, and a second configuration, in which the coupler is in fluid communication with the fluid reservoir. The adapter is configured to be coupled to the coupler of the handle. The adapter is at least temporarily coupled to a sterilization member and to the sample reservoir such that an inlet surface of the sample reservoir is maintained in a substantially sterile environment collectively defined by the adapter and the sterilization member prior to the adapter being coupled to the coupler of the handle. The sterilization member is at least partially removed from the adapter when the adapter is coupled to the coupler of the handle.
In some embodiments, a method for parenterally-procuring bodily-fluid samples with reduced contamination from microbes exterior to the bodily-fluid source includes establishing fluid communication between a patient and a first fluid reservoir, which in turn, is in selective fluid communication with a transfer adapter. A volume of bodily-fluid is withdrawn from the patient and into the first fluid reservoir. A second fluid reservoir is coupled to the to the transfer adapter. The second fluid reservoir has an inlet surface and is coupled to a sterilization member configured to at least temporarily obstruct the inlet surface. The sterilization member is moved relative to the inlet surface such that the inlet surface is unobstructed by the sterilization member as the second fluid reservoir is coupled to the transfer adapter. The second fluid reservoir is placed in fluid communication with the transfer adapter when the portion of the second fluid reservoir is coupled to the transfer adapter and the inlet surface is unobstructed by the sterilization member. Fluid communication between the first fluid reservoir and the second fluid reservoir is established and a volume of bodily-fluid is transferred from the first fluid reservoir to the second fluid reservoir.
In some embodiments, an apparatus includes a sterilization and/or disinfection member at least temporarily coupled to a sample reservoir. The sample reservoir includes an inlet port that is configured to be fluidically coupled to a transfer device to receive a volume of bodily-fluid directly from a patient or indirectly from the patient via an intermediary bodily-fluid collection device. The sterilization and/or disinfection member is configured to be placed in contact with the transfer device and transitioned from a first configuration, in which the sterilization and/or disinfection member fluidically isolates the inlet port of the fluid reservoir, to a second configuration, in which at least a portion of the sterilization and/or disinfection member is spaced apart from the sample reservoir. The sample reservoir is configured to be placed in fluid communication with the transfer device via the inlet port when the sterilization and/or disinfection member is in the second configuration.
In some embodiments, a sterilization and/or disinfection member is coupled to a sample reservoir during a manufacturing process in a position that prevents the clinician from collecting and/or transferring a bodily-fluid sample into a fluid reservoir(s) without engaging the sterilization and/or disinfection member to at least substantially sterilize a connection therebetween, which in turn, facilitates fluid communication of a bodily-fluid sample between the patient and the collection vessel. By ensuring that substantially no external contaminants and/or biological matter (e.g., skin cells, tumor cells, organ tissue, etc.) external to the target bodily-fluid source are captured in the sample vessel, diagnostic results can improve with increased consistency. With accurate diagnostic results, clinicians can derive an accurate treatment/action plan, thereby reducing the likelihood of misdiagnosing a patient, prescribing unnecessary treatment, holding the patient in a clinical and/or hospital setting for an undue and/or unnecessary period of time, and/or the like, which in turn, can substantially reduce a risk of the patient developing a further ailment (e.g., antibiotic complications, adverse drug reactions, hospital-acquired infection, and/or the like) as well as substantially reduce costs to hospital and/or other healthcare institutions, third party payers and the healthcare systems as a whole.
As used in this specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a member” is intended to mean a single member or a combination of members, “a material” is intended to mean one or more materials, or a combination thereof.
As referred to herein, “bodily-fluid” can include any fluid obtained from a body of a patient, including, but not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, and the like, or any combination thereof.
As used herein, the term “set” can refer to multiple features or a singular feature with multiple parts. For example, when referring to set of walls, the set of walls can be considered as one wall with distinct portions, or the set of walls can be considered as multiple walls. Similarly stated, a monolithically constructed item can include a set of walls. Such a set of walls can include, for example, multiple portions that are in discontinuous from each other. A set of walls can also be fabricated from multiple items that are produced separately and are later joined together (e.g., via a weld, an adhesive or any suitable method).
As used herein, the words “proximal” and “distal” refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device.
As used herein, the term “disinfecting agent” refers to a chemical or combination of chemicals used to disinfect and/or to substantially sterilize or maintain the sterility of a surface. A disinfecting agent can be in any suitable form (e.g., gaseous, aqueous, or solid). In some embodiments, a disinfecting agent can be an antiseptic or the like that can be used to kill, destroy, and/or otherwise substantially neutralize negative effects from microbes such as, for example, germs, bacteria, viruses, and/or other target microorganisms. In some embodiments, a disinfecting agent can be in an aqueous form and substantially suspended by a porous substrate. In other embodiments, a surface of a substrate such as a wipe or diaphragm can be impregnated by and/or coated with a disinfecting agent. A non-limiting list of disinfecting agents can include, for example, alcohol (e.g., ethanol, 1-propanol, 2-proponal, isopropanol, and/or the like), quaternary ammonium compounds ((e.g., benzalkonium chloride (BAC), cetyl trimethylammonium bromide (CTMB), cetylpyridinium chloride (Cetrim (CPC)), benzethonium chloride (BZT) and/or the like), boric acid, chlorhexidine gluconate, hydrogen peroxide, iodine, octenidine dihydrochloride, phenol, polyhexanide (e.g., polyhexamethylene biguanide (PHMB)), sodium bicarbonate, silver compounds (e.g., silver nitrate, silver proteinate, chlorhexidine-silver-sulfadiazine, and/or the like), and/or any other suitable disinfectant or antiseptic, and/or a combination thereof. Moreover, any of the disinfecting agents can be used with, for example, a binding agent, a suspension agent, a surfactant, and/or the like.
The collection device 100 includes a transfer adapter 120, a fluid reservoir 140, and a sterilization and/or disinfection member 150. The transfer adapter 120 has a proximal end portion 121 and a distal end portion 122, and defines an inner volume 130 therebetween. The transfer adapter 120 can be any suitable shape, size, or configuration. For example, the transfer adapter 120 can be substantially cylindrical, including a set of annular walls that define at least a portion of the inner volume 130. In other embodiments, the transfer adapter 120 can be polygonal such as rectangular, pentagonal, octagonal, etc. Moreover, as shown in
The proximal end portion 121 of the transfer adapter 120 can be substantially open to movably receive at least a portion of the fluid reservoir 140. In other words, at least a portion of the fluid reservoir 140 can be inserted through the proximal end portion 121 of the transfer adapter 120 to dispose that portion of the fluid reservoir 140 within the inner volume 130. As described in further detail herein, once the portion of the fluid reservoir 140 is disposed within the inner volume 130 of the transfer adapter 120, the fluid reservoir 140 can be moved from a first position in which the sterilization and/or disinfection member 150 obstructs, covers, engages, disinfects, and/or otherwise substantially maintains the sterility of a port of the fluid reservoir 140 to a second position in which the sterilization and/or disinfection member 150 is at least partially disengaged from the fluid reservoir 140 to allow access to the port.
Although not shown in
In some embodiments, the transfer adapter 120 can be physically and fluidically coupled to a transfer device that includes and/or is coupled to a peripheral intravenous (IV) needle or a peripheral IV catheter, which places the transfer device in fluid communication with a portion of the patient. In other embodiments, the transfer adapter 120 can be placed in fluid communication with any suitable intermediary device, which contains and/or receives a bodily-fluid collected from a patient in a separate and/or independent step. In some embodiments, the intermediary device can be a collection device, a diversion device, a syringe-based collection device and/or the like such as those described in U.S. Pat. No. 8,535,241 entitled, “Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed Sep. 17, 2013 (the “'241 patent”); U.S. Pat. No. 9,060,724 entitled, “Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed May 29, 2013 (the “'724 patent”); U.S. Pat. No. 9,204,864 entitled, “Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed Jul. 29, 2013 (the “'864 patent”); U.S. Patent Publication No. 2014/0155782 entitled, “Sterile Bodily-Fluid Collection Device and Methods,” filed Dec. 4, 2013 (the “'782 publication”); and/or U.S. Pat. No. 9,155,495 entitled, “Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed Dec. 2, 2013 (the “'495 patent”), the disclosures of which are incorporated herein by reference in their entireties. In addition, the transfer adapter 120 can include a puncture member or the like (as described above) in fluid communication with such a transfer device, which in turn, can puncture a portion, surface, and/or port of the fluid reservoir 140 to establish fluid flow path between the patient and the fluid reservoir 140. Although described as being physically and fluidically coupled to a transfer device, in other embodiments, the transfer adapter 120 can be monolithically formed with a transfer device. In still other embodiments, the transfer adapter 120 can be operably coupled to a transfer device via any suitable intervening structure (e.g., via sterile flexible tubing, one or more cannulas, one or more intermediate devices, one or more fluid reservoirs, and/or the like).
Although not shown in
As described above, the fluid reservoir 140 is configured to be placed in fluid communication with the transfer adapter 120 to, for example, receive a volume of bodily-fluid from a patient. In some embodiments, the fluid reservoir 140 includes a surface 141 that can be pierced, punctured, and/or otherwise placed in an open configuration to place an inner volume of the fluid reservoir 140 in fluid communication with a volume outside of the fluid reservoir 140. For example, in some embodiments, the surface 141 can include and/or can define a frangible portion, a port, a septum, and/or the like that can be pierced, for example, by a puncture member included in the transfer adapter 120 to place the inner volume of the fluid reservoir 140 in fluid communication with transfer adapter 120 and any suitable device coupled thereto, as described in further detail herein.
The fluid reservoir 140 can be any suitable shape, size, and/or configuration that can receive and/or store a volume of a bodily-fluid. For example, in some embodiments, the fluid reservoir 140 can be any suitable reservoir described in U.S. Pat. No. 8,197,420 (“the '420 patent”), entitled, “Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination,” filed on Dec. 13, 2007, the disclosure of which is incorporated herein by reference in its entirety. In some embodiments, the fluid reservoir 140 can define a negative pressure and/or otherwise can be substantially evacuated. For example, in some embodiments, the fluid reservoir 140 can be a BacT/ALERT® SN or a BacT/ALERT® FA (manufactured by BIOMERIEUX, INC.), a BD Vacutainer® or a BD Microtainer® (manufactured Becton, Dickinson, and Company (BD)), a Nanotainer™ (manufactured by Theranos), and/or any suitable reservoir, syringe, vial, microvial, microliter vial, container, microcontainer, or the like.
In some embodiments, the fluid reservoir 140 can be any suitable sample or culture bottle such as, for example, an aerobic or anaerobic culture bottle containing a culture medium. In such embodiments, a bodily-fluid sample volume can be delivered and/or transferred into the a culture bottle (e.g., the fluid reservoir 140) and after a given time, incubation period, or the like, microbes contained in the bodily-fluid sample can flourish or grow within the culture medium. After the incubation period, the bodily-fluid sample can be tested to determine quantitative and/or qualitative information associated with such microbial growth within the culture medium. In some instances, for example, the bodily-fluid samples can be tested via real-time diagnostics including molecular PCR-based technologies, genetic testing/diagnostics, and/or any other suitable test. In some instances, results of such testing can be indicative of the presence of Gram-Positive bacteria, Gram-Negative bacteria, fungi, yeast (e.g., Candida), and/or any other contaminants or organisms contained within the bodily-fluid sample, which in turn, is indicative of their presence within the patient. As described above, however, contaminants or microbes external to the body of the patient that are transferred into the inner volume of fluid reservoir 140 and/or otherwise entrained in the flow of the bodily-fluid sample can result in false positive or false negative results when testing bodily-fluid sample. Thus, disposing the sterilization and/or disinfection member 150 about a fluidic interface of the fluid reservoir 140 (e.g., at least a portion of the surface 141) prior to use can reduce a likelihood of such contaminants being transferred into the fluid reservoir 140, as described in further detail herein.
The sterilization and/or disinfection member 150 can be any suitable sterilization and/or disinfection member and/or mechanism that is at least temporarily coupled to a portion of the fluid reservoir 140 to at least temporarily maintain a sterility of the portion of the fluid reservoir 140. In some embodiments, the sterilization and/or disinfection member 150 can disinfect the portion of the fluid reservoir 140 to remove contaminants and/or the like. The sterilization and/or disinfection member 150 (also referred to herein as “sterilization member”) can be, for example, a pad, a swab, a diaphragm, a sponge, a wipe, a cap, a foil, and/or the like that can include and/or the can at least partially house a disinfecting agent. In some embodiments, the sterilization member 150 can be a diaphragm or the like that can have at least one surface that is substantially impregnated with a disinfecting agent such as those described above. In some embodiments, the sterilization member 150 can include and/or can define a portion that is substantially porous, for example, to act as a substrate for the disinfection agent. In other embodiments, the sterilization member 150 can include a surface that is formed from a disinfecting material such as, for example, a silver compound.
In some embodiments, the sterilization member 150 can be a sheet, foil, cap, membrane, diaphragm, and/or the like that can form a substantially fluid tight seal with a portion of the fluid reservoir 140. For example, the sterilization member 150 can be coupled to, in contact with, and/or otherwise disposed about at least a portion of the surface 141 of the fluid reservoir 140 such that at least the portion of the surface 141 is maintained in a substantially sterile environment prior to use. For example, in some embodiments, such a sterilization member 150 can be coupled to the fluid reservoir 140 during a manufacturing process performed in a substantially sterile environment. In some embodiments, a disinfecting agent can be disposed within the volume at least partially circumscribed by a seal formed by the sterilization member 150 (e.g., ethylene oxide gas, gamma radiation or the like can be used to create a sterile environment within the inner volume).
In use, a user (e.g., a doctor, nurse, technician, physician, phlebotomist, etc.) can manipulate the collection device 100 to at least indirectly couple the transfer adapter 120 to a lumen-defining device, transfer device, collection device, diversion device, etc. such as, for example, a standard winged butterfly needle, a syringe, a peripheral IV catheter, and/or the like. In some embodiments, such a device can be any of those described in the '241 patent, the '724 patent, the '348 publication, the '782 publication, and/or the '419 publication. In some instances, such a device can be placed in communication with a patient prior to being coupled to the transfer adapter 120. In other instances, the transfer adapter 120 can be coupled to, for example, a needle or cannula prior to being inserted (e.g., percutaneously) into the patient. With the transfer adapter 120 in fluid communication with the patient, the user can manipulate the collection device 100 to insert at least a portion of the fluid reservoir 140 into the proximal end portion 121 of the transfer adapter 120. In some embodiments, prior to inserting the fluid reservoir 140, the user can manipulate the collection device 100 to remove, for example, a seal that substantially covers the proximal end 121 of the transfer adapter 120, as described above.
The user can move the fluid reservoir 140 relative to the transfer adapter 120 to place the fluid reservoir 140 in a first position within the inner volume 130, thereby placing the collection device 100 in a first configuration. In some instances, the sterilization member 150 can be placed in contact with a portion of the transfer adapter 120 such as an inner surface and/or any suitable feature extending from the inner surface when the collection device 100 is in the first configuration. For example, as described above, in some embodiments, the inner surface of the transfer adapter 120 can include a surface feature, contour, protrusion, slot, cutting member, peeling member, and/or the like configured to engage the sterilization member 150 as the fluid reservoir 140 is inserted and/or moved within the inner volume 130 of the transfer adapter 120. In some instances, the user can maintain the fluid reservoir 140 in the first position for a predetermined time (which in some embodiments, is facilitated by physical design characteristics that prevent the user from bypassing the first position) to ensure the sterilization member 150 is engaged with and/or otherwise in contact with a desired portion of the transfer adapter 120 prior to moving the fluid reservoir 140 from the first position to a second position within the transfer adapter 120. In other embodiments, the fluid reservoir 140 need not be held in the first position for the predetermined time. That is to say, in some embodiments, the user can move the fluid reservoir 140 relative to the transfer adapter 120 (or vice versa) in a substantially continuous manner to move the fluid reservoir 140 through the first position and into the second position.
Once the fluid reservoir 140 has been placed at or near a desired position within the transfer adapter 120, a portion of the surface 141 (e.g., a portion including a port, septum, seal, etc.) can be exposed and/or otherwise unobstructed by the sterilization member 150. In other words, placing the fluid reservoir 140 in a desired position within the transfer adapter 120 can transition the sterilization member 150 from a first configuration, in which the sterilization member 150 engages the surface 141 to substantially maintain the sterility of at least a portion of the surface 141, to a second configuration, in which at least a portion of the sterilization member 150 is disengaged from the surface 141. Specifically, the transfer adapter 120 can remove at least a portion of the sterilization member 150 from contact with the surface 141 as the fluid reservoir 140 is placed in the second position, as indicated by the arrow AA in
With the sterilization member 150 in, for example, the second configuration, a user can then manipulate the transfer adapter 120 and/or the fluid reservoir 140 to place the fluid reservoir 140 in fluid communication with the transfer adapter 120, as described in detail above. Thus, the collection device 100 can be used to maintain the sterility of a fluidic interface associated with the surface 141 of the fluid reservoir 140 to reduce the likelihood of contamination from microbes disposed on the surface 141. By having the sterilization member 150 coupled to the fluid reservoir 140 prior to use, contamination of a sample of bodily-fluid can be reduced that might otherwise result from insufficient disinfection by a user. In addition, having the transfer adapter 120 automatically remove the sterilization member 150 as the fluid reservoir 140 is moved relative to the transfer adapter 120 can ensure compliance with a substantially consistent sterilization and/or disinfection process, which in turn, can reduce inaccurate test results, costs, and time associated with collecting and testing a sample volume.
In some embodiments, the collection device 100 and/or the transfer adapter 120 can be included in and/or can form at least a portion of a preassembled and/or all-in-one collection device. In such embodiments, the preassembled and/or all-in-one collection device can include, for example, any suitable number of fluid reservoirs (e.g., one fluid reservoir, two fluid reservoirs, three fluid reservoirs, four fluid reservoirs, or more) that can be preassembled with and/or incorporated in (e.g., unitarily formed with) a transfer device including a sterilization and/or disinfection member such as those described herein. By way of example, in some embodiments, the collection device 100 (and/or any suitable portion thereof) can be included in and/or can otherwise form a portion of a preassembled and/or all-in-one collection device such as those described in '782 publication incorporated by reference above.
While described above as maintaining at least a portion of the surface 141 of the fluid reservoir 140 in a substantially sterile environment, in some embodiments, the sterilization member 150 can be configured to disinfect the surface 141 of the fluid reservoir 140. That is to say, the sterilization member 150 can be used to remove contaminants from the surface 141 of the fluid reservoir 140 (i.e., to disinfect the surface 141 of the fluid reservoir 140). The sterilization and/or disinfection members described herein, therefore, are not intended to be limited to either function and, for simplicity, are referred to henceforth as “sterilization members.”
Referring to
The fluid reservoir 240 can be any suitable reservoir for containing a bodily-fluid, including, for example, a single use disposable collection reservoir, a vacuum based collection reservoir (e.g., maintaining negative pressure conditions that can produce a suction or vacuum force), a sample reservoir as described in the '420 patent, and/or the like. While shown as having a bottle shape or the like, the fluid reservoir 240 can be any suitable bottle, tube, vial, microvial, container, syringe, etc. In some embodiments, the reservoir 240 can be an aerobic culture bottle or an anaerobic culture bottles. That is to say, the fluid reservoir 240 can include an aerobic or anaerobic culture medium disposed within an inner volume defined by the fluid reservoir 240, as described in detail above with reference to the fluid reservoir 140. Moreover, the culture medium disposed therein can be associated with one or more tests, procedures, and/or actions configured to, for example, detect the presence of certain microbes that are known to thrive in that medium. In other embodiments, the fluid reservoir 240 can include common additives such as heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, and/or the like that are used to preserve specific characteristics and/or qualities of a bodily-fluid sample (e.g., blood) prior to diagnostic analysis.
In the embodiment shown in
As shown in
In some embodiments, the label 242 can include a volumetric indicator portion or the like that can provide a visual indicator associated with the bodily-fluid disposed in the fluid reservoir 240. For example, the volumetric indicator portion can include a set of evenly spaced lines, tic marks, dashes, arrows, markers, and/or any other suitable gradation or indicia that can be associated with a specific volume of the fluid reservoir 240 if filled to that point. In some embodiments, the fluid reservoir 240 can be substantially transparent, allowing the user to visualize the sample disposed therein. For example, a user can visually assess the volume of the bodily-fluid disposed in the fluid reservoir 240 by determining at what point along the indicator portion the meniscus of the bodily-fluid aligns. In some embodiments, a device can be coupled to the fluid reservoir 240 that is configured to verify and/or otherwise indicate a volume of bodily-fluid transferred into the fluid reservoir such as, for example, those described in U.S. patent application Ser. No. 15/146,967 entitled, “Devices and Methods for Verifying a Sample Volume,” filed May 5, 2016, the disclosure of which is incorporated herein by reference in its entirety. In some such embodiments, verifying and/or otherwise indicating a volume of bodily-fluid transferred into the fluid reservoir (e.g., the fluid reservoir 240) can facilitate the transfer of a desired and/or predetermined volume of the bodily-fluid into the fluid reservoir, which in turn, can limit false test results otherwise associated with an undesirable volume of the bodily-fluid (e.g., too much bodily-fluid or too little bodily-fluid for a given test or tests).
Although the fluid reservoir 240 is specifically described above, in other embodiments, the fluid reservoir 240 can be any suitable shape, size, and/or configuration. For example, while the fluid reservoir 240 is shown and described as including the label 242 configured to provide a user with information associated with the fluid reservoir 240, in other embodiments, a fluid reservoir without a label and/or other identifying portion can be used.
As described above, in some embodiments, the fluid reservoir 240 can be coupled to and/or can include a sterilization member that can be at least partially disengaged from the fluid reservoir 240 when the fluid reservoir 240 is positioned within a transfer adapter or device. For example,
The collection device 300 (or portion thereof) as shown in
The housing 345 can be any suitable shape, size, and/or configuration. For example, in some embodiments, the housing 345 can have a size and/or shape that is associated with a size and/or shape of the fluid reservoir to be disposed therein. More particularly, the housing 345 defines an inner volume that is sufficient to receive at least the first and second fluid reservoir 340. As shown in
In some embodiments, the fluid reservoirs 340 can be disposed in the housing 345 and the sterilization member 350 can be coupled to the housing 345 during manufacturing. In such embodiments, for example, the housing 345 can be substantially sterilized using standard medical sterilization practices (e.g. ethylene oxide, gamma radiation, e-beam, and/or the like) to facilitate maintenance of a sterile environment. Similarly, the fluid reservoirs 340 can be substantially sterilized and disposed in the inner volume of the housing 345 while the housing 345 and the fluid reservoirs 340 are in the sterile environment. Likewise, the sterilization member 350 can be substantially sterilized and coupled to the housing 345, after the fluid reservoirs 340 have been disposed therein, while the housing 345, the fluid reservoirs 340, and the sterilization member 350 are disposed in the sterile environment. Thus, while the sterilization member 350 is coupled to the housing 345 and in an unused configuration, the inner volume of the housing 345 (containing the fluid reservoirs 340) is a substantially sterile volume and/or environment. For example, in some embodiments, housing 345, fluid reservoirs 340, sterilization member 350 can be assembled (as described above) in a sterile environment such as ethylene oxide gas or the like. Moreover, by sealing the housing 345 with the sterilization member 350, the fluid reservoirs 340 within the inner volume of the housing 345 are maintained in, for example, an ethylene oxide gas environment until the housing 345 is unsealed.
The sterilization member 350 can be any shape, size, and/or configuration suitable for coupling to the housing 345. For example, the sterilization member 350 can be one or more films, foils, sheets, membranes, diaphragms, and/or the like. More particularly, the sterilization member 350 can include a first portion 356 that is removably coupled to a second portion 357. The first portion 356 can be, for example, a base configured to be coupled to the housing 345. As such, the first portion 356 can be formed from a relatively stiff material that can provide structural integrity for the sterilization member 350 to be coupled to the housing 345. The second portion 357 can be removably coupled to the first portion 356 and can be formed from a relatively flexible material to allow the second portion 357 to deform, bend, fold, peel, and/or otherwise at least partially disengage from the first portion 356. Furthermore, a surface of the sterilization member 350 (e.g., of the first portion 356) in contact with the surface of the housing 345 can have and/or can define an area that is greater than an area defined by the surface of the housing 345. In other words, the sterilization member 350 can form a flange or the like that extends beyond a perimeter of the housing 345, as shown in
Prior to use, the arrangement of the sterilization member 350 is such that the second portion 357 is coupled to the first portion 356 to form a substantially fluid tight seal and/or interface. In some embodiments, for example, a perimeter of the second portion 357 (or an area near a perimeter) can be coupled to an associated perimeter of the first portion 356 via an adhesive or ultrasonic weld. In other embodiments, substantially the entirety of a surface of the second portion 357 can be adhered to substantially the entirety of a surface of the first portion 356. In still other embodiments, the second portion 357 can be coupled to the first portion 356 in any suitable manner. Moreover, the second portion 357 is coupled to the first portion 356 in such a manner that the first portion 356 and the second portion 357 collectively form a substantially sterile area. For example, in some embodiments, a substantially sterile area can be circumscribed by a seal defined by the coupling of the second portion 357 to the first portion 356. In some embodiments, the second portion 357 can be coupled to the first portion 356 via an adhesive, which in turn, is impregnated with and/or otherwise includes a sterilizing agent such as those described above. Thus, the sterility of an area of the first portion 356 of the sterilization member 350 aligned with and/or covering, for example, the opening of the housing 345 is maintained prior to use.
The transfer adapter 320 can be any suitable transfer adapter. For example, in some embodiments, the transfer adapter 320 can be substantially similar to the transfer adapter 120 described above with reference to
The inner surface 323 defines a set of channels 324 configured to engage a portion of the sterilization member 350 as the housing 345 is inserted into the inner volume 330. More particularly, the channels 324 can slidably receive a portion of the sterilization member 350 that extends beyond the perimeter of the housing 345 (as described above) and can define a substantially linear range of motion of the housing 345 and the sterilization member 350 relative to the transfer adapter 320. In addition, the arrangement of the channels 324 can be such that as the sterilization member 350 is inserted into the channels 324 and the housing 345 is moved relative to the transfer adapter 320, a portion of the inner surface of the transfer adapter 320 defining the channels 324 peels, removes, decouples, and/or otherwise disengages the second portion 357 of the sterilization member 350 from the first portion 356 of the sterilization member 350, thereby exposing a surface of the first portion 356 that is aligned with and/or otherwise covers at least a portion of the opening defined by the housing 345.
For example, in use, a user can place the transfer adapter 320 in fluid communication with a lumen-defining device, transfer device, collection device, diversion device, and/or the like, which in turn, is in fluid communication with a portion of the body of a patient or an intermediary device containing a bodily-fluid, as described in detail above with reference to the transfer adapter 120. Moreover, the housing 345, the fluid reservoirs 340, and the sterilization member 350 can be in a first configuration in which the sterilization member 350 seals the inner volume of the housing 345 such that the fluid reservoirs 340 disposed therein are maintained in a substantially sterile environment. The user can manipulate the transfer adapter 320 and/or the housing 345 to insert the portion of the sterilization member 350 into the channels 324. As the user inserts the portion of the sterilization member 350 into the channels 324, the portion of the inner surface 323 that defines the channels 323 is placed in contact with the sterilization member 350. As the housing 345 is moved relative to the transfer adapter 320, the portion of the inner surface 323 disengages, peels, and/or otherwise decouples the second portion 357 of the sterilization member 350 from the first portion 356 of the sterilization member 350. As such, the substantially sterile surface of the first portion 356 that is aligned with and/or otherwise covers at least a portion of the opening defined by the housing 345 is exposed.
Once the user places the housing 345—and thus, the fluid reservoirs 340 disposed therein—in a desired position relative to the transfer adapter 320, the user can manipulate the collection device 300 (or portion thereof) to place the transfer adapter 320 in fluid communication with at least one of the fluid reservoirs 340. For example, in some embodiments, the user can actuate an actuator configured to advance a puncture member or the like through a surface of the fluid reservoir 340, thereby placing at least one of the fluid reservoirs 340 in fluid communication with the patient. Thus, at least one of the fluid reservoirs 340 can receive a flow of bodily-fluid from the patient or an intermediary device containing a bodily-fluid.
The arrangement of the collection device 300 (or portion thereof) is such that the sterility of the fluid reservoirs 340 within the housing 345 and the surface of the first portion 356 of the sterilization member 350 is maintained until a time relatively shortly before the transfer adapter 320 is placed in fluid communication with the fluid reservoirs 340. Similarly, although not shown in
Although the collection device 300 is shown and described above as including the housing 345 within which the fluid reservoirs 340 are disposed and to which the sterilization member 350 is coupled, in other embodiments, fluid reservoirs need not be disposed within a housing and can be coupled directly to a sterilization member. For example,
Some aspects of the collection device 400 can be similar in form and function to associated aspects of the collection devices 100, 200, and/or 300 (and/or components thereof) described above. For example, the embodiment shown in
The transfer adapter 420 of the collection device 400 can be any suitable transfer adapter. For example, in some embodiments, the transfer adapter 420 can be substantially similar to the transfer adapter 120 described above with reference to
The inner surface 423 defines a set of channels 424 configured to engage a portion of the sterilization member 450 as the fluid reservoir 440 is inserted into the inner volume 430. For example, the channels 424 can slidably receive a portion of the sterilization member 450 to guide the sterilization member 450 and/or the fluid reservoir 440 to which it is coupled as the fluid reservoir 440 is moved relative to the transfer adapter 420, as described in further detail herein. In addition, the transfer adapter 420 and/or the inner surface 423 thereof includes an engagement portion 426 configured to engage a seal 457 or the like of the sterilization member 450 as the sterilization member 450 is moved relative to the transfer adapter 420 (e.g., as the portion of the sterilization member 450 is moved within the channels 424 as a result of the fluid reservoir 440 being moved relative to the transfer adapter 420). For example, the engagement portion 426 can extend from the inner surface 423 and can include a protrusion, tab, flange, etc. configured to be placed in contact with a portion of the seal 457 of the sterilization member 450. Moreover, the engagement portion 426 is operable in transitioning the sterilization member 450 from a first configuration to a second configuration, as described in further detail herein.
The sterilization member 450 of the collection device 400 can be any suitable sterilization member and/or mechanism. In the embodiment shown in
As shown in
As described above, the sterilization member 450 includes the seal 457. In the embodiment shown in
As shown in
In use, a user can place the transfer adapter 420 in fluid communication with a lumen-defining device, transfer device, collection device, diversion device, and/or the like, which in turn, is in fluid communication with a portion of the body of a patient (or intermediary device containing a bodily-fluid, as described in detail above with reference to the transfer adapter 120. Moreover, the fluid reservoirs 440 and the sterilization member 450 can be in a first configuration in which the sterilization member 450 maintains the sterility of at least the portion of the fluid reservoir 440 (e.g., a fluidic interface such as a surface or port).
The user can manipulate the transfer adapter 420 and/or the fluid reservoir 440 to insert the portion of the sterilization member 450 into the channels 424, as described above with reference to the collection device 300. As the user inserts the portion of the sterilization member 450 into the channels 424, the engagement portion 426 of the inner surface 423 is placed in contact with the portion of the seal 457 of the sterilization member 450. More specifically, the ramp portion 453 of the sterilization member 450 defines a channel 454 or slot that exposes the portion of the seal 457 defining the aperture 458. As such, movement of the sterilization member 450 (and fluid reservoir 440) within the inner volume 430 disposes the engagement portion 426 (or a protrusion extending therefrom) in the aperture 458 defined by the portion of the seal 457, as shown in
With the engagement portion 426 disposed in the aperture 458, further movement of the sterilization member 450 advances the sterilization member 450 relative to the engagement portion 426 of the transfer adapter 420, which in turn, removes, disengages, peels, and/or otherwise decouples at least a portion of the seal 457 from the sterilization member 450, as shown in
Once the user places the sterilization member 450—and thus, the fluid reservoirs 440 coupled thereto—in the desired position relative to the transfer adapter 420, the user can manipulate the collection device 400 (or portion thereof) to place the transfer adapter 420 in fluid communication with at least one of the fluid reservoirs 440. For example, in some embodiments, the user can actuate an actuator configured to advance a puncture member or the like through the opening 455 of the sterilization member 450 and through a surface or port of the fluid reservoir 440, thereby placing at least one of the fluid reservoirs 440 in fluid communication with the patient or an intermediary device containing a bodily-fluid. While not shown, in other embodiments, coupling the collection device 400 to the fluid reservoirs 440 can automatically facilitate access such that bodily-fluid flow begins as soon as physical coupling is complete. Thus, the fluid reservoir 440 can receive a flow of bodily-fluid from the patient or intermediary device containing bodily-fluid.
As described above with reference to the collection device 300, the arrangement of the collection device 400 (or portion thereof) is such that the sterility of at least the portion of the fluid reservoir 440 in contact with the sterilization member 450 is maintained until a time relatively shortly before the transfer adapter 420 is placed in fluid communication with the fluid reservoir 440. Thus, by maintaining the sterility of a fluidic interface between the transfer adapter 420 and the fluid reservoir 440 until a relatively short time before placing the transfer adapter 420 in fluid communication with the fluid reservoirs 440, the probability of external contaminants being transferred into the bodily-fluid sample received by the fluid reservoir 440 can be reduced. Moreover, pre-sterilizing fluidic interfaces and automatically exposing those fluidic interfaces just before establishing fluid communication between the transfer adapter 420 and the fluid reservoir 440 can increase compliance with sterilization protocols and ease of performing the procedure, as well as reduce costs and inadvertent mistakes.
Referring now to
The transfer adapter 520 of the collection device 500 can be any suitable transfer adapter. For example, in some embodiments, the transfer adapter 520 can be substantially similar in form and/or function to the transfer adapters 120, 220, 320, and/or 420 described above. Thus, aspects of the transfer adapter 520 are not described in further detail herein. As shown in
The inner surface 523 includes a first portion 525 and a second portion 527. The first portion 525 defines a set of channels 524 configured to engage a portion of the sterilization member 550 as the fluid reservoir 540 is inserted into the inner volume 530, as described above with reference to the transfer adapter 320 and 420. For example, the channels 524 can slidably receive a portion of the sterilization member 550 to guide the sterilization member 550 and/or the fluid reservoir 540 to which it is coupled when the fluid reservoir 540 is moved relative to the transfer adapter 520, as described in further detail herein.
As shown, for example, in
The sterilization member 550 of the collection device 500 can be any suitable sterilization member and/or mechanism. In the embodiment shown in
As shown in
In use, a user can place the transfer adapter 520 in fluid communication with a lumen-defining device, transfer device, collection device, diversion device, and/or the like, which in turn, is in fluid communication with a portion of the body of a patient (or intermediary device containing a bodily-fluid, as described in detail above with reference to the transfer adapter 120. Moreover, the fluid reservoir 540 and the sterilization member 550 can be in a first configuration in which the sterilization member 550 obstructs, covers, and/or otherwise fluidically isolates the surface 541 of the fluid reservoir to substantially maintain the sterility of the surface 541. The user can manipulate the transfer adapter 520 and/or the fluid reservoir 540 to insert the flange 563 of the collar 560 into the channels 524, as described above, for example, with reference to the collection device 300. As the user inserts the portion of the sterilization member 550 into the inner volume 530 of the transfer adapter 520, sterilization member 550 is placed in contact with the edge surface 528, as shown in
With the sterilization member 550 in contact with the ramp portion 529 of the edge surface 528, further movement of the sterilization member 550 into the inner volume 530 advances the sterilization member 550 relative to the ramp portion 529, which in turn, removes, disengages, peels, and/or otherwise decouples the sterilization member 550 from the fluid reservoir 540, as shown in
With the sterilization member 550 decoupled from the fluid reservoir 540, the surface 541 of the fluid reservoir 540 is substantially exposed. In some embodiments, the desired position of the fluid reservoir 540 within the transfer adapter 520 can substantially align a portion of the surface 541 (e.g., a port or other fluidic interface) with a transfer member (e.g., a puncture member such as a sheathed needle or the like). Thus, with the fluid reservoir 540 in the desired position relative to the transfer adapter 520, the user can manipulate the collection device 500 (or portion thereof) to place the transfer adapter 520 in fluid communication with the fluid reservoir 540. For example, in some embodiments, the user can actuate an actuator configured to advance a puncture member or the like through a port or fluidic interface of the surface 541 of the fluid reservoir 540, thereby placing the fluid reservoir 540 in fluid communication with the patient. While not shown, in other embodiments, the physical process of coupling the collection device 500 to the fluid reservoir 540 via the transfer adapter 520 automatically facilitates a flow path for bodily-fluid without specific user manipulation. Thus, the fluid reservoir 540 can receive a flow of bodily-fluid from the patient or intermediary device containing a bodily fluid.
As described above with reference to the collection device 300, the arrangement of the collection device 500 (or portion thereof) is such that the sterility of at least the surface 541 of the fluid reservoir 540 is maintained until a time relatively shortly before the transfer adapter 520 is placed in fluid communication with the fluid reservoir 540. Thus, by maintaining the sterility of a fluidic interface between the transfer adapter 520 and the fluid reservoir 540 until a relatively short time before placing the transfer adapter 520 in fluid communication with the fluid reservoirs, the probability of external contaminants being transferred into the bodily-fluid sample received by the fluid reservoir 540 can be reduced. Moreover, pre-sterilizing fluidic interfaces and automatically exposing those fluidic interfaces just before establishing fluid communication between the transfer adapter 520 and the fluid reservoir 540 can increase compliance with sterilization protocols and ease of performing the procedure, as well as reduce costs and inadvertent mistakes.
As described above, the transfer adapters 120, 220, 320, 420, and 520 can be included in and/or coupled to any suitable device configured to receive a fluid of bodily-fluid from a patient. Such devices can be any suitable collection device, transfer device, diversion device, and/or the like. For example,
As shown in
The distal end portion 612 includes a coupler 613 or the like configured to be physically and fluidically coupled to any suitable transfer adapter such as, for example, those described herein. In other embodiments, the coupler 613 can form an integrated transfer adapter or the like. As such, the coupler 613 is configured to be at least indirectly physically and fluidically coupled to any suitable device and/or mechanism configured to transfer bodily-fluid to and/or from the collection device 600, as described in further detail herein.
The handle 610 also includes a system actuator 615 configured to initiate, modulate, divert, and/or otherwise control a flow of the bodily-fluid through the handle 610. Although not shown in
The coupler 613 of the handle 610 can be coupled to any suitable device. For example, as shown in
In a similar manner, the coupler 613 can be at least indirectly coupled to one or more fluid reservoirs 640A and/or 640B. For example, as shown in
As shown in
In some embodiments, the adapter 646 can include an actuator 647, which can direct a flow of bodily-fluid from the fluid reservoir(s) 619 within the handle 610 and through the adapter 646 when actuated. In other words, the actuator 647 of the adapter 646 can selectively place the fluid reservoirs 640A and/or 640B in fluid communication with the coupler 613 of the handle 610. In some embodiments, coupling the adapter 646 to the coupler 613 can automatically establish fluid communication between the fluid reservoirs 640A and/or 640B and the handle 610. For example, in some embodiments, the coupler 613 can include one or more puncture members configured to puncture a portion of the adapter 646 and the fluid reservoir(s) 640A and 640B when the adapter 646 is coupled thereto. In other embodiments, the coupling of the adapter 646 to the coupler 613 at least partially removes and/or decouples a sterilization member such that an inlet surface, interface, and/or the like of the fluid reservoir(s) 640A and/or 640B is unobstructed. In such embodiments, the puncture members of the coupler 613 need not puncture a portion of the adapter 646 in conjunction with and/or prior to puncturing, for example, an inlet surface of the fluid reservoirs 640A and/or 640B. Thus, bodily-fluid stored within the fluid reservoir(s) 619 in the handle 610 can be transferred to the fluid reservoirs 640A and/or 640B, which in turn, can be used in any suitable testing and/or analysis process.
In some instances, reducing a number of fluidic interfaces along a fluid flow path can reduce a likelihood of contaminants being transferred into a volume of bodily-fluid flowing within the fluid flow path. Thus, the modular arrangement of the collection device 600 can result in a reduction of contaminants in the bodily-fluid that is ultimately transferred into the fluid reservoirs 640A and/or 640B. Although not shown in
As shown in
The proximal end portion 711 of the handle 710 can include and/or can be coupled to any suitable port or the like configured to be placed in fluid communication with the fluid reservoir(s) 719 disposed within the handle 710, as described above with reference to the handle 610. The distal end portion 712 includes a coupler 713 or the like configured to be physically and fluidically coupled to any suitable transfer adapter such as, for example, those described herein. In other embodiments, the coupler 713 can form an integrated transfer adapter or the like. As such, the coupler 713 is configured to be at least indirectly physically and fluidically coupled to any suitable device and/or mechanism configured to transfer bodily-fluid to and/or from the collection device 700, as described in further detail herein.
The coupler 713 of the handle 710 can be coupled to any suitable device. For example, as shown in
As shown in
As described above with reference to the collection device 600, after a volume of bodily-fluid is transferred to the fluid reservoir(s) 719 disposed within the handle 710, the coupler 713 can be at least indirectly coupled to one or more fluid reservoirs 740A and/or 740B (e.g., external fluid reservoirs and/or sample reservoirs). For example, as shown in
When the adapter 746 is coupled to the coupler 713, the fluid reservoirs 740A and/or 740B can be placed in fluid communication with, for example, the one or more fluid reservoirs 719 within the handle 710. As described above, the adapter 746 can include an actuator 747 that can direct a flow of bodily-fluid from the fluid reservoir(s) 719 within the handle 710 and through the adapter 746 when actuated. In other words, the actuator 747 of the adapter 746 can selectively place the fluid reservoirs 740A and/or 740B in fluid communication with the coupler 713 and/or the fluid reservoirs 719 within the handle 710. Thus, bodily-fluid stored within the fluid reservoir(s) 719 in the handle 710 can be transferred to the fluid reservoirs 740A and/or 740B, which in turn, can be used in any suitable testing and/or analysis process, as described above with reference to the collection device 600.
As shown in
The collection device 800 includes and/or forms a handle 810 having a proximal end portion 811 and a distal end portion 812. The proximal end portion 811 of the handle 810 can include and/or can be coupled to any suitable port or the like configured to be placed in fluid communication with one or more fluid reservoirs, as described above with reference to the handle 610. As shown, the distal end portion 812 of the handle 810 is physically and fluidically coupled to a lumen-defining device 816 such as sterile flexible tubing. The lumen-defining device 816 can include a needle 818 or cannula disposed at a first end of the lumen-defining device 816 that is configured to puncture or pierce the skin of a patient to place the lumen-defining device 816 in fluid communication with the patient. A second end of the lumen-defining device 816 is fixedly coupled to the distal end portion 812 of the handle 810. That is to say, the lumen-defining device 816 can be integrated into the handle 810 and/or otherwise not coupled to an adapter, which in turn, would otherwise be coupled to a coupler of the handle 810 (e.g., as described above with reference to the lumen-defining devices 616 and 716). Thus, as described in detail above with reference to the collection devices 600 and 700, the lumen-defining device 816 can transfer bodily-fluid from a patient to one or more fluid reservoir(s) 819 disposed within the handle 810, as described in further detail herein.
The handle 810 also includes a coupler 813 and a system actuator 815. The system actuator 815 is configured to initiate, modulate, divert, and/or otherwise control a flow of the bodily-fluid through the handle 810. Although not shown in
As described above with reference to the collection devices 600 and 700, the coupler 813 is configured to be physically and fluidically coupled to any suitable transfer adapter such as, for example, those described herein. In other embodiments, the coupler 813 can form an integrated transfer adapter or the like. While the couplers 613 and 713 are shown and described above as being included in and/or disposed at a distal end portion 612 and 712, respectively, of the handles 610 and 710, respectively, in the embodiment shown in
The coupler 813 is configured to be physically and fluidically coupled (at least indirectly) to any suitable device and/or mechanism configured to transfer bodily-fluid to and/or from the collection device 800. For example, as shown in
Although the adapters 646 and 746 are described above as having an actuator, in the embodiment illustrated in
As described above with reference to the portion of the collection device 300, the embodiment shown in
As shown in
In some embodiments, the actuator 815 can be configured to remain in a locked configuration until a volume of bodily-fluid is transferred into, for example, the fluid reservoir 870 (e.g., a pre-sample reservoir). Thus, in some instances, contaminants contained in a fluid flow path defined between the fluid reservoir(s) 819 within the handle 810 and the coupler can be transferred into the fluid reservoir 870. In such instances, after the volume of bodily-fluid is transferred into the fluid reservoir 870, the fluid reservoir 870 can be removed from the coupler 813, which in turn, can sequester the contaminants in the fluid reservoir 870. Thus, subsequent volumes of bodily-fluid transferred to the fluid reservoirs 840A and/or 840B can be substantially free from contaminants. Moreover, disposing the actuator 815 in a locked configuration prior to a volume of bodily-fluid being transferred into the fluid reservoir 870 can ensure a user first collects the volume of bodily-fluid in the fluid reservoir 870, which can reduce an amount of contaminants transferred into the fluid reservoirs 840A and 840B, as described above.
While the handles 610, 710, and 810 are each described above as including the coupler 613, 713, and 813, respectively, that is configured to couple to an adapter, in other embodiments, a handle can include multiple couplers each of which can be coupled to an adapter. For example, in some embodiments, a handle can include a first coupler disposed at, for example, a distal end portion of the handle (e.g., similar to the couplers 613 and 713 described above). The first coupler can be configured to couple to an adapter in fluid communication with, for example, a lumen-defining device that can be placed in fluid communication with one or more fluid reservoirs disposed within the handle when coupled to the first coupler. The handle can also include a second coupler disposed at, for example, a proximal end portion of the handle (e.g., similar to the coupler 813 described above). The second coupler can be configured to couple to an adapter in fluid communication with, for example, one or more sample reservoirs that can be placed in fluid communication with the one or more fluid reservoirs disposed within the handle when coupled to the second coupler. In such embodiments, a volume of bodily-fluid can be transferred from the patient into the one or more fluid reservoirs within the handle, as described above with reference to the handles 610, 710, and/or 810. A volume of the bodily-fluid within the one or more fluid reservoirs within the handle can then be transferred into the sample reservoirs coupled to the second coupler, as described above with reference to the handles 610, 710, and/or 810.
In some embodiments, the first fluid reservoir can be in fluid communication with a lumen-defining device or the like that defines at least a portion of a fluid flow path between the patient and the first fluid reservoir. For example, the lumen-defining device can be coupled to and/or can include a needle at a first end and can be coupled to the first fluid reservoir and/or other suitable flow path at a second end (e.g., opposite the first end), as described above with reference to the collection device 800. In some embodiments, the lumen-defining device can be coupled to and/or included in an adapter or the like configured to couple to a portion of a fluid transfer device that includes the first fluid reservoir, as described above with reference to the collection devices 600 and/or 700. In some embodiments, fluid communication between the first fluid reservoir and the lumen-defining device (and thus, the patient) can be in response to, for example, an actuation of an actuator or the like, as described above with reference to the collection devices 600, 700, and/or 800.
Once fluid communication is established between the first fluid reservoir and the patient, a volume of bodily-fluid can be withdrawn from the patient and into the first fluid reservoir, at 12. Alternatively, as described above, the method 10 can optionally include withdrawing a pre-sample volume of bodily-fluid into one or more pre-sample reservoirs prior to transferring the volume of bodily-fluid to the first fluid reservoir. The pre-sample volume can then be sequestered in the pre-sample volume prior to transferring the bodily-fluid to the first fluid reservoir. In some instances, transferring bodily-fluid to the first fluid reservoir can be blocked and/or substantially prevented until a pre-sample volume has been sequestered in a pre-sample reservoir.
With the volume of bodily-fluid contained in the first fluid reservoir, a second fluid reservoir is coupled to a transfer adapter in fluid communication with the first fluid reservoir, at 13. The transfer adapter can be any of those described herein. In some embodiments, the transfer adapter can be substantially similar to the coupler 613 described above with reference to
The sterilization member is moved relative to the inlet surface of the second fluid reservoir such that fluid communication can be established between the second fluid reservoir and the transfer adapter, at 14. For example, in some embodiments, the transfer adapter can include a surface, a feature, a contour, a protrusion, etc. configured to be placed in contact with the sterilization member as the second fluid reservoir is coupled to the transfer adapter (e.g., occurring at substantially the same time and/or in a single process). In this manner, as the second fluid reservoir moves relative to the transfer adapter to couple thereto, the sterilization member is moved, for example, from a first configuration to a second configuration. In some embodiments, for example, the sterilization member can be at least partially removed from the second fluid reservoir such that the inlet surface is substantially unobstructed, as described in detail above with reference to specific embodiments.
With the inlet surface of the second fluid reservoir substantially unobstructed, fluid communication is established between the first fluid reservoir and the second fluid reservoir, at 15. For example, in some embodiments, a user or the like can actuate an actuator that can be operable to define a fluid flow path between the first fluid reservoir and the second fluid reservoir. In some embodiments, such an actuation of the actuator can, for example, advance one or more puncture members relative to the second fluid reservoir such that a portion of the puncture member punctures or pierces the inlet surface of the second fluid reservoir, as described above. In some embodiments, multiple actuators can be actuated to establish fluid communication between the first fluid reservoir and the second fluid reservoir. Once fluid communication is established between the first fluid reservoir and the second fluid reservoir, a volume of bodily-fluid is transferred from the first fluid reservoir to the second fluid reservoir, at 16. In some instances, maintaining the sterility of at least a portion of the fluid reservoir prior to use and/or maintaining the sterility of one or more interfaces which are coupled to define at least a portion of a fluid flow path, can result in reduced contamination within a sample volume of bodily-fluid transferred to the second fluid reservoir. Similarly, withdrawing a pre-sample volume of bodily-fluid into a pre-sample reservoir and sequestering the pre-sample volume within the pre-sample reservoir can also reduce contaminants that may otherwise be present in a sample volume transferred to the second fluid reservoir.
Any of the embodiments described herein can include components that are manufactured, packaged, and sold independently or collectively. For example, in some instances, any of the embodiments described herein can be manufactured, assembled, and packaged collectively during a manufacturing process. In such instances, one or more sterilization members, such as those described herein, can be positioned within a collection device and/or coupled to a sample reservoir during a manufacturing process (e.g., during assembly), which can be performed, for example, in a substantially sterile environment and/or facilitated using post-manufacturing standard medical sterilization techniques (e.g. ethylene oxide, gamma radiation, e-beam, or the like). Moreover, the position of the sterilization member can be such that during use, a clinician is substantially prevented from collecting and/or transferring a bodily-fluid sample into a fluid reservoir(s) without engaging the sterilization member to at least substantially sterilize a connection between the collection device and the fluid reservoir.
Although not shown, any of the embodiments and/or methods described herein can be used in conjunction with and/or otherwise in the methods described in the '782 publication incorporated by reference above. For example, the embodiments, described herein can be used to collect a bodily-fluid sample, which in turn can be used in any of the testing methods, diagnostic methods, and/or analysis methods described in the '782 publication.
While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. For example, although not shown, the embodiments and/or methods described herein can be used with any suitable fluid transfer device configured to receive a flow of bodily-fluid from a patient and at least temporarily store and/or otherwise transfer at least a portion of the bodily-fluid to one or more sample reservoirs. Similarly, in some embodiments, such a fluid transfer device can be used to transfer bodily-fluid to a transfer adapter such as those described herein, which in turn, can transfer at least a portion of the bodily-fluid to one or more fluid reservoirs (e.g., sample reservoirs). In some embodiments, such a fluid transfer device can be any of those described in the '241 patent, the '724 patent, the '864 patent, the '495 patent, and/or the '782 publication.
For example, in some instances, the embodiments described herein can be used with a syringe-based fluid transfer device. In some such instances, the use of a syringe-based device can allow a user to manually control a flow of bodily-fluid into a syringe (e.g., the transfer device) by modulating a force exerted on an actuator or plunger. For example, in some instances, a user can control a rate of fluid transfer and/or an amount of negative pressure, which, in the case of drawing a volume of blood, can limit and/or reduce a risk of hemolysis of the volume of blood, a risk of vein collapse, a risk of inaccurate volume collection, and/or the like. In some embodiments, such a syringe-based transfer device can be similar to any of those described in the '495 patent. In some embodiments, once a desired volume of bodily-fluid (e.g., blood) is drawn into the syringe-based device, any of the transfer adapters and/or fluid reservoirs (with or without sterilization members coupled thereto) can be coupled to and/or placed in fluid communication with the syringe-based device such that a desired volume of bodily-fluid can be transferred into one or more fluid reservoirs (e.g., sample reservoirs). In other embodiments, any of the transfer adapters and/or devices described herein can be integrated into and/or otherwise included in a syringe-based transfer device.
While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments as discussed above.
By way of example, while the sterilization members 150, 350, 450, 550, 650, 750, and/or 850 have been described above as substantially maintaining the sterility of a surface of a fluid reservoir, in other embodiments, any of the sterilization members described herein can be used to disinfect a surface of a fluid reservoir. For example, in some embodiments, any of the sterilization members can be coupled to a portion of a fluid reservoir in a substantially sterile environment during a manufacturing process or the like such as those described herein. Thus, in such embodiments, the sterilization members can be configured to maintain the sterility of the portion of the fluid reservoir. In other embodiments, however, any of the sterilization members described herein can be coupled to a portion of a fluid reservoir in a non-sterile environment during a manufacturing process and/or by a user prior to use. Thus, in such embodiments, the sterilization members can be configured to disinfect the portion of the fluid reservoir (e.g., an inlet surface or the like) and/or otherwise remove contaminants from the portion of the fluid reservoir. Accordingly, while described above as “sterilization members” configured to maintain the sterility of a portion of a fluid reservoir, it should be understood that such members can be, for example, “disinfection members” configured to disinfect the portion of the fluid reservoir.
The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired rate of bodily-fluid flow into a fluid reservoir. Similarly, the size and/or specific shape of various components can be specifically selected for a desired fluid reservoir. For example, portions of the embodiments described herein can be modified such that any suitable container, microcontainer, microliter container, vial, microvial, microliter vial, nanovial, sample bottle, culture bottle, tube, syringe, etc. can be placed in contact with a disinfection member to sterilize one or more interfaces associated therewith prior to a bodily-fluid being drawn into a volume so defined.
Where methods and/or events described above indicate certain events and/or procedures occurring in certain order, the ordering of certain events and/or procedures may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.
This application is a continuation of U.S. patent application Ser. No. 15/925,159 entitled, “Apparatus and Methods for Maintaining Sterility of a Specimen Container,” filed Mar. 19, 2018, which is a divisional of U.S. patent application Ser. No. 15/257,185 entitled, “Apparatus and Methods for Maintaining Sterility of a Specimen Container,” filed Sep. 6, 2016, now U.S. Pat. No. 9,950,084, which claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 62/213,875 entitled, “Apparatus and Methods for Maintaining Sterility of a Specimen Container,” filed Sep. 3, 2015, the disclosure of each of which is incorporated herein by reference in its entirety.
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| Number | Date | Country | |
|---|---|---|---|
| 20200215211 A1 | Jul 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62213875 | Sep 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15257185 | Sep 2016 | US |
| Child | 15925159 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15925159 | Mar 2018 | US |
| Child | 16815521 | US |
