Method and apparatus for selectively occluding lumen of needle

Abstract

To provide an improved fluid transfer device, a catheter introduction technique and device, and a method for transferring fluid to or from a patient, in which microbial contamination and inadvertent injection of external undesirable microorganism into a blood stream of a patient are reduced.SOLUTION: A fluid transfer device for parenterally transferring fluid to and / or from a patient includes a housing, a needle, and an occlusion mechanism. The housing defines a fluid flow path and is couplable to a fluid reservoir. The needle has a distal end portion that is configured to be inserted into the patient and a proximal end portion that is configured to be fluidically coupled to the fluid flow path of the housing, and defines a lumen therebetween. The occlusion mechanism selectively controls a fluid flow between the needle and the fluid flow path. The occlusion mechanism includes an occlusion member that is movable between a first configuration where the lumen of the needle is obstructed during insertion into the patient and a second configuration where the lumen of the needle is unobstructed after the needle is inserted into the patient allowing fluid transfer to or from the patient.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001]

[1001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 61 / 777,758, entitled "Lumenless Needle for Bodily Fluid Sample Collection," filed March 12, 2013, the disclosure of which is incorporated herein by reference in its entirety.

[0002]

[1002] The embodiments described herein relate generally to transferring fluids to or from a patient, and more specifically to devices and methods for transferring fluids to or from a patient with reduced contamination from microorganisms or other contaminants and / or fluid sources external to the body, such as skin-resident microorganisms. [Background technology]

[0003]

[1003] Human skin is normally inhabited by small and variable amounts of certain bacteria, such as coagulase-negative Staphylococcus species, Proprionobacterium acnes, Micrococcus species, Viridans Streptococcus, Corynebacterium species, and Bacillus species. These bacteria often live in a symbiotic relationship with human skin, but in some circumstances can cause serious bloodstream infections known as sepsis. Sepsis caused by these skin-resident organisms is often associated with internal nidus of bacterial growth at the site of damaged tissue, such as damaged and scarred heart valves or foreign bodies (often artificial joints, blood vessels, or valves). In addition, there are predisposing factors for these infections, such as malignancies, immunosuppression, diabetes mellitus, obesity, rheumatoid arthritis, psoriasis, and advanced age. In some cases, these infections can lead to serious illness and / or death. In addition, these infections can be very expensive and difficult to treat, and often involve medical-related legal issues.

[0004]

[1004] In general medical practice, blood is withdrawn from veins (phlebotomy) for two primary purposes: (1) to obtain donor blood in volumes of approximately 500 mL for the treatment of anemia, deficiencies in blood clotting factors including platelets, and other conditions, and (2) to obtain small volumes of blood (e.g., a few drops to 10 mL or more) for testing purposes. In either case, whether donor or test specimen, a fluid communicator (e.g., catheter, cannula needle, etc.) is used to penetrate and enter the vein (known as venipuncture) and allow the withdrawal of a desired amount of blood into a tube or container device for handling, transport, storage, and / or other purposes. The venipuncture site, most commonly the antecubital fossa, is prepared by irrigation with a germicidal agent to prevent the growth of skin-resident bacteria in the blood withdrawn from the vein. It has been found that the venipuncture needle removes a fragment of skin, including hair and sweat gland structures, as well as subcutaneous fat and other adnexal structures that are not completely sterilized by disinfection of the skin surface. These skin fragments can lead to sepsis, false positive blood cultures, and other undesirable outcomes in recipients of donor blood products. Additionally, methods, procedures, and devices are used to divert the initial portion of the venipuncture blood and allow for the exclusion of these skin fragments from the venipuncture specimen to prevent sepsis, false positive blood cultures, and other undesirable outcomes in recipients of donor blood products.

[0005]

[1005] Venipuncture is also the most common method of accessing a patient's bloodstream to deliver parenteral fluids to the bloodstream of a patient who requires this type of medication. Fluids in a container are flowed into the patient's bloodstream through tubing connected to a venipuncture needle or a catheter placed in the patient's vascular system (e.g., peripheral vein, central line, etc.). During this process, incompletely disinfected pieces of skin carrying viable skin-resident microorganisms may be delivered into the bloodstream along with the parenteral fluid flow and / or during venipuncture for introduction and insertion of a peripheral catheter. These pieces are undesirable in the bloodstream, and their introduction into the patient's bloodstream (whether by removal of the pieces by the venipuncture needle when inserting the catheter or by delivery through tubing attached to the needle or catheter) is contrary to good antiseptic practices. Furthermore, these skin pieces carrying viable microorganisms may be accompanied by the well-known phenomenon of colonization by skin-resident organisms of the luminal surfaces of tubing and tubing connectors used to deliver parenteral fluids. Although colonization does not usually indicate true infection, it can cause false-positive blood cultures and may result in antibiotic treatment, laboratory testing, and replacement of tubing equipment, all of which are unnecessary, with attendant patient risks and costs. Additionally, there is an increased risk of clinically significant infection with resident skin organisms.

[0006]

[1006] Thus, there is a need for improved fluid transfer devices, catheterization techniques and devices, and methods for transferring fluids to or from a patient that reduce microbial contamination and the inadvertent introduction of unwanted foreign microorganisms into the patient's bloodstream. Summary of the Invention

[0007]

[1007] Described herein are devices and methods for delivering fluids and / or introducing peripheral catheters to a patient with reduced contamination from skin-resident microorganisms or other external body contaminants. In some embodiments, a fluid transfer device for parenterally transferring fluids to and / or from a patient includes a housing, a needle, and an occlusion mechanism. The housing defines a fluid flow path and is coupleable to a fluid reservoir. The needle has a distal portion configured to be inserted into a patient and a proximal portion configured to be fluidly coupled to the fluid flow path of the housing. The needle defines a lumen between the proximal and distal portions. The occlusion mechanism is operable to selectively control fluid flow between the needle and the fluid flow path. The occlusion mechanism includes an occlusion member that is transitionable between a first configuration in which the lumen of the needle is occluded during insertion into the patient and a second configuration in which the lumen of the needle is unoccluded after the needle is inserted into the patient, allowing fluid transfer to or from the patient. [Brief description of the drawings]

[0008] [Figure 1] FIG. 2 is a schematic diagram of a fluid transfer device in a first configuration, according to one embodiment. [Diagram 2] FIG. 2 is a schematic diagram of a fluid transfer device in a second configuration, according to one embodiment. [Diagram 3] FIG. 1 is a perspective view of a fluid transfer device according to one embodiment. [Figure 4] 4 is a cross-sectional view of the fluid transfer device of FIG. 3 taken along line X1-X1 when in a first configuration. [Diagram 5] 4 is a cross-sectional view of the fluid transfer device of FIG. 3 taken along line X1-X1 when in a second configuration. [Figure 6] FIG. 1 is a perspective view of a fluid transfer device according to one embodiment. [Figure 7] 7 is a cross-sectional view of the fluid transfer device of FIG. 6 taken along line X2-X2 when in a first configuration. [Figure 8] 8 is an enlarged view of a portion of the fluid transfer device of FIG. 6 in a first configuration and designated as region Z1 in FIG. 7. [Figure 9]8 is an enlarged view of a portion of the fluid transfer device of FIG. 6 in a first configuration and designated as region Z2 in FIG. 7. [Figure 10] 7 is a cross-sectional view of the fluid transfer device of FIG. 6 taken along line X2-X2 when in a second configuration. [Figure 11] 11 is an enlarged view of a portion of the fluid transfer device of FIG. 6 in a second configuration and designated as region Z3 in FIG. 10. [Figure 12] 11 is an enlarged view of a portion of the fluid transfer device of FIG. 6 in a first configuration and indicated in FIG. 10 as region Z4. [Figure 13] FIG. 1 is a perspective view of a fluid transfer device according to one embodiment. [Figure 14] 14 is a cross-sectional view of the fluid transfer device of FIG. 13 taken along line X3-X3 when in a first configuration. [Figure 15] 15 is an enlarged view of a portion of the fluid transfer device of FIG. 13 in a first configuration and indicated in FIG. 14 as region Z5. [Figure 16] 14 is a cross-sectional view of the fluid transfer device of FIG. 13 taken along line X3-X3 when in a second configuration. [Figure 17] 17 is an enlarged view of a portion of the fluid transfer device of FIG. 13 in a second configuration and designated as region Z6 in FIG. 16. [Figure 18] FIG. 1 is a perspective view of a fluid transfer device according to one embodiment. [Figure 19] 19 is a cross-sectional view of the fluid transfer device of FIG. 18 taken along line X4-X4 when in a first configuration. [Figure 20] 19 is an enlarged view of a portion of the fluid transfer device of FIG. 18 in a first configuration and indicated in FIG. 19 as region Z7. [Figure 21] 19 is a cross-sectional view of the fluid transfer device of FIG. 18 taken along line X4-X4 when in a second configuration. [Figure 22] 21 is an enlarged view of a portion of the fluid transfer device of FIG. 18 in a second configuration and indicated in FIG. 21 as region Z8. [Figure 23] FIG. 1 is a perspective view of a fluid transfer device according to one embodiment. [Figure 24]24 is a cross-sectional view of the fluid transfer device of FIG. 23 taken along line X5-X5 when in a first configuration. [Diagram 25] 24 is an enlarged view of a portion of the fluid transfer device of FIG. 23 in a first configuration and indicated as region Z9 in FIG. 24. [Figure 26] 24 is a cross-sectional view of the fluid transfer device of FIG. 23 taken along line X5-X5 when in a second configuration. [Figure 27] 26 is an enlarged view of a portion of the fluid transfer device of FIG. 23 in a second configuration and shown as region Z10 in FIG. 26. [Figure 28] FIG. 1 is a perspective view of a fluid transfer device according to one embodiment. [Figure 29] FIG. 29 is an enlarged view of a portion of the fluid transfer device of FIG. 28 in a first configuration and indicated as region Z11. [Diagram 30] FIG. 29 is an enlarged view of a portion of the fluid transfer device of FIG. 28 in a second configuration and indicated as region Z11. [Diagram 31] 1 is a flow chart illustrating a method of transferring fluid to or from a patient that reduces microbial contamination and inadvertent injection of unwanted foreign microorganisms into the patient's bloodstream. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009]

[1038] In some embodiments, a fluid transfer device for parenterally transferring fluid to and / or from a patient includes a housing, a needle, and an occlusion mechanism. The housing defines a fluid flow path and is coupleable to a fluid reservoir. The needle has a distal portion configured to be inserted into a patient and a proximal portion configured to be fluidly coupled to the fluid flow path of the housing. The needle defines a lumen between the proximal and distal portions. The occlusion mechanism is operable to selectively control fluid flow between the needle and the fluid flow path. The occlusion mechanism includes an occlusion member movable between a first configuration in which the lumen of the needle is occluded during insertion into the patient and a second configuration in which the lumen of the needle is unoccluded after the needle is inserted into the patient, allowing fluid transfer to or from the patient.

[0010]

[1039] In some embodiments, a fluid transfer device for parenterally transferring fluid to and / or from a patient includes a needle and an occlusion mechanism. The needle has a proximal portion configured to be fluidly coupled to a fluid reservoir and a distal portion configured to be inserted into the patient. The needle defines a lumen between the proximal portion and the distal portion. The occlusion mechanism is operable to selectively control the flow of fluid between the patient and the fluid reservoir. The occlusion mechanism has a first configuration in which the lumen of the needle is occluded during insertion into the patient and a second configuration in which the lumen of the needle is unoccluded after the needle is inserted into the patient, allowing fluid transfer to or from the patient. The occlusion mechanism is configured to automatically transition from the first configuration to the second configuration when the distal portion of the needle is inserted into the patient.

[0011]

[1040] In some embodiments, a method for transferring fluid to or from a patient uses a parenteral transfer device having a needle and an occlusion mechanism. The needle defines a lumen and is configured to be inserted into the patient. The occlusion mechanism is operable to selectively control the flow of fluid to or from the patient through the lumen of the needle. The method includes placing the occlusion mechanism in a first configuration in which the lumen of the needle is occluded to prevent tissue, bodily fluids and contaminants from entering the lumen. The method includes inserting the needle into the patient and, after the needle is inserted into the patient, moving the occlusion mechanism to a second configuration in which the lumen of the needle is unoccluded to allow fluid transfer to or from the patient.

[0012]

[1041] As used herein, "body fluid" may include any fluid obtained from a patient's body, including, but not limited to, blood, cerebrospinal fluid, urine, bile, lymphatic fluid, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, etc., or any combination thereof.

[0013]

[1042] As used herein, the term "set" can mean multiple features or a single feature with multiple parts. For example, when talking about a set of walls, the set of walls can be considered as one wall with distinct parts, or the set of walls can be considered as multiple walls. Similarly, an integrally assembled article can include a set of walls. Such a set of walls can include, for example, multiple parts that are discontinuous with each other. A set of walls can also be made from multiple articles that are made separately and then joined together (e.g., by welds, adhesives, or any suitable method).

[0014]

[1043] As used herein, the terms "proximal" and "distal" refer to directions toward and away from a user who brings the device into contact with a patient, respectively. Thus, for example, the end of the device that first touches the patient's body is the distal end, and the opposite end of the device (e.g., the end of the device that is manipulated by the user) is the proximal end of the device.

[0015]

[1044] 1 and 2 are schematic diagrams of a fluid transfer device 100 according to one embodiment in a first and second configuration, respectively. Generally, the fluid transfer device 100 (also referred to herein as a "transfer device") is configured to facilitate insertion of a piercing member (e.g., a needle, trocar, cannula, etc.) into a patient and selectively occlude the lumen of the piercing member to transfer fluid to or from the patient with reduced contamination, e.g., by skin-resident microorganisms.

[0016]

[1045] As shown in FIG. 1, the transfer device 100 includes a housing 101, a needle 120, and an occlusion mechanism 140. As described in more detail herein, the transfer device 100 may be coupled to a fluid reservoir 130 that may receive a fluid flow from the transfer device 100 and / or transfer a fluid flow to the transfer device 100. The housing 101 may be of any suitable shape, size, or configuration, specific embodiments of which are described in more detail herein. As shown in FIG. 1, a portion of the housing 101 may be physically and fluidly coupled, at least temporarily, to the needle 120. For example, in some embodiments, a distal portion of the housing 101 may include a port (not shown in FIGS. 1 and 2) configured to physically and fluidly couple to a locking mechanism (not shown in FIGS. 1 and 2) included within the needle 120. In such embodiments, the locking mechanism may be, for example, a Luer-Lok® or the like that may engage the port. In some embodiments, the housing 101 may be integrally formed with at least a portion of the needle 120. In this manner, as described in further detail herein, a portion of the housing 101 can receive bodily fluids from a patient and / or deliver parenteral fluids to a patient through a lumen 123 defined by the needle 120.

[0017]

[1046] Similarly, the housing 101 is fluidly coupled to the fluid reservoir 130. In some embodiments, the proximal portion of the housing 101 may include a port or a locking mechanism (e.g., Luer-Lok®) that may engage a portion of the fluid reservoir 130 to physically and fluidly couple the housing 101 to the fluid reservoir 130. In other embodiments, the housing 101 may be coupled to an intervening structure, such as a cannula, configured to fluidly couple the housing 101 to the fluid reservoir 130. Although shown in FIGS. 1 and 2 as being disposed externally of the housing 101, in some embodiments, the fluid reservoir 130 may be disposed substantially internally of the housing 101 (e.g., at least a portion of the housing 101 may define the fluid reservoir 130). In this manner, the housing 101 may be configured to define a fluid flow path 108 between the needle 120 and the fluid reservoir 130, as described in further detail herein. The fluid reservoir 130 may be any suitable reservoir, such as, for example, those described in U.S. Patent No. 8,197,420, entitled "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination," filed December 13, 2007 (the "'420 Patent"), the entire disclosure of which is incorporated herein by reference. In some embodiments, the fluid reservoir may be similar to known fluid reservoirs, such as, for example, the BacT / ALERT® SN or BacT / ALERT® FA manufactured by BIOMERIEUX, INC. and / or the standard Vacutainer® or Microtainer® manufactured by Becton Dickinson. In this manner, the external fluid reservoir may be configured such that a negative or subatmospheric pressure exists within the interior volume of the reservoir. In other embodiments, the fluid reservoir 130 may contain a fluid (e.g., saline, medication, etc.) intended for delivery to the patient.In yet other embodiments, the fluid reservoir 130 can be any suitable reservoir, such as a vial, microvial, microliter vial, container, microcontainer, nanovial (e.g., Nanotainer™ by Theranos), etc. In some embodiments, the fluid reservoir 130 can be any suitable sample or culture bottle, such as, for example, an aerobic culture bottle, an anaerobic culture bottle, etc., which can contain a culture medium, etc. In this manner, the culture bottle can receive a bodily fluid sample, which can then be tested for the presence of, for example, gram-positive bacteria, gram-negative bacteria, yeast, and / or any other organism, and then tested using, for example, a polymerase chain reaction (PCR) based system to identify the specific organism. In some cases, the culture bottle can receive a bodily fluid sample, and the culture medium (disposed within the culture bottle) can be tested for the presence of any suitable organism. If such a culture medium tests positive, the culture medium can then be tested using a PCR based system to identify the specific organism.

[0018]

[1047] The needle 120 of the delivery device 100 has a proximal portion 121 and a distal portion 122 defining a lumen 123 therebetween. The proximal portion 121 can physically and fluidly couple the needle 120 to the housing 101 (e.g., the proximal portion 121 can be a locking mechanism as described above). In some embodiments, a portion of the housing 101 can be formed around the proximal portion 121 of the needle 120, thereby coupling the needle 120 to the housing 101. For example, in some embodiments, the needle 120 can be formed from a metal (e.g., stainless steel, etc.) or an engineering plastic (e.g., polymers, thermoplastics, glass-filled polymers, carbon-filled polymers, ceramic-based polymers, etc.), and the housing 101 can be formed from a thermoplastic (e.g., polyethylene, polypropylene, polyamide, polycarbonate, silicone, urethane, and silicone / urethane copolymer (hybrid) materials, etc.). In such an embodiment, the housing 101 may, for example, be overmolded around the proximal portion 121 of the needle 120 to fixedly couple the needle 120 to the housing 101 .

[0019]

[1048] The tip portion 122 of the needle 120 can be inserted into a portion of a patient to deliver fluid to or receive fluid from the patient. For example, in some embodiments, the tip portion can include a tip with a sharp point (e.g., a bevel) configured to pierce a portion of a patient, for example, to place the tip portion 122 in a vein. In other embodiments, a piercing member (e.g., a needle defining a lumen) can be movably disposed within the needle 120 (e.g., a trocar) to facilitate insertion of the tip portion 120 into a portion of a patient. In some embodiments, at least a portion of the needle 120 (e.g., the tip portion) can include an antibiotic that is formulated to kill bacteria dislodged during venipuncture and prevent contamination of the fluid sample and / or the patient. For example, an exterior surface and / or a portion of the lumen 123 of the needle 120 can include a coating that includes the antibiotic. In some embodiments, the piercing member (e.g., a trocar) can include a coating that includes the antibiotic. The distal end portion 122 of the needle 120 may define one or more openings that fluidly connect the lumen 123 of the needle 120 with a volume external to the needle 120. For example, in some embodiments, the distal end (e.g., tip) is substantially open. In other embodiments, the tip may be closed and the needle 120 may define one or more openings along the periphery of the needle 120 (i.e., along a sidewall of the needle 120). In such embodiments, the openings may be arranged in any suitable manner. For example, in some embodiments, the openings may be arranged linearly along the length of the needle 120. In other embodiments, the openings may be arranged linearly (e.g., perpendicular to the length of the needle 120) along the periphery of the needle 120. In still other embodiments, the openings may be arranged in a non-linear arrangement.

[0020]

[1049] The occlusion mechanism 140 of the delivery device 100 may be included within or coupled to the housing 101. In some embodiments, the occlusion mechanism 140 may be at least partially disposed within the housing 101. The occlusion mechanism 140 may be any suitable mechanism configured to direct, occlude, or otherwise control fluid flow. More specifically, the occlusion mechanism 140 includes an occlusion member 141 that may be moved (e.g., pushed, pulled, rotated, slid, bent, or otherwise reconfigured) between a first configuration (FIG. 1) and a second configuration (FIG. 2). In some embodiments, the occlusion member 141 may be moved manually. In other embodiments, the occlusion member 141 is pushed by actuation of a portion of the occlusion mechanism 140. In still other embodiments, the occlusion member 140 may be automatically converted (e.g., reconfigured) from the first configuration to the second configuration, as described in more detail herein.

[0021]

[1050] While in the first configuration, the occlusion member 141 can fluidly isolate at least a portion of the lumen 123 defined by the needle 120 from the fluid flow path 108 defined by the housing 101, and when moved to the second configuration (FIG. 2), the occlusion member 141 can allow the lumen 123 of the needle 120 to be in fluid communication with the fluid flow path 108 of the housing 101. For example, in some embodiments, when in the first configuration, the occlusion member 141 can be at least partially disposed within the lumen 123 of the needle 120 such that a portion of the lumen 123 distal to the occlusion member 141 is fluidly isolated from the fluid flow path 108 defined by the housing 101. In such embodiments, when in the second configuration, the occlusion member 141 is removed from the lumen 123 such that substantially the entire lumen 123 of the needle 120 is in fluid communication with the fluid flow path 108 defined by the housing 101 (see, e.g., FIG. 2).

[0022]

[1051] Although the occlusion member 141 is shown in FIGS. 1 and 2 as being disposed within the needle 120, in other embodiments, the occlusion member 141 may be disposed around at least a portion of the needle 120. For example, in some embodiments, the occlusion member 141 may form a sheath or the like that substantially surrounds at least a portion of the needle 120. In such embodiments, when in a first configuration, the occlusion member 141 may block or surround one or more openings (described above) defined by the needle 120, and may move relative to the needle 120 (i.e., to a second configuration) to substantially expose the one or more openings. In this manner, the lumen 123 of the needle 120 may remain in fluid communication with the fluid flow passage 108 of the housing 101, and the occlusion member 141 may fluidly isolate the lumen 123 of the needle 120 from a volume substantially external to the needle 120. In some embodiments, a portion of the needle 120 may form the occlusion mechanism 140. For example, at least a portion of needle 120 may be formed from a shape memory alloy that reconfigures when exposed to certain conditions (e.g., may move to form an opening when exposed to temperature within the body). In other embodiments, at least a portion of needle 120 may be configured to dissolve when exposed to bodily fluids (e.g., a coating is disposed about a portion of needle 120 such that when tip portion 122 is inserted into a patient, the coating comes into contact with bodily fluids and is thereby dissolved).

[0023]

[1052] In use, the occlusion member 141 can be in a first configuration to fluidly isolate at least a portion of the lumen 123 of the needle 120 from the fluid flow path 108 defined by the housing 101. The tip portion 122 of the needle 120 can be inserted into a portion of a patient for placement, for example, in a vein. In this manner, skin-resident microorganisms dislodged during a venipuncture event (e.g., when the needle 120 and / or the occlusion member 141 pierces the patient's skin) are isolated from the fluid flow path 108 of the housing 101. Once the tip portion 122 of the needle 120 is placed in a vein, the occlusion member 141 can move to a second configuration, as shown by arrow AA in FIG. 2. For example, the occlusion member 141 can be in the first configuration within a portion of the lumen 123 of the needle 120 when the needle 120 is inserted into a vein, and the occlusion member 141 can be substantially removed from the lumen 123 of the needle 120 to place the delivery device 100 in the second configuration. In this manner, the lumen 123 of the needle 120 is in fluid communication with bodily fluids and also in fluid communication with the fluid flow passage 108 of the housing 101 .

[0024]

[1053] Although not shown in FIGS. 1 and 2, in some embodiments, the occlusion mechanism 140 may include an actuator configured to move the occlusion member 141 between a first configuration and a second configuration. For example, in some embodiments, the actuator may be a push button, a slider, a toggle, a pull tab, a handle, a dial, a lever, an electronic switch, or any other suitable actuator. In this manner, the actuator may move between a first position corresponding to the first configuration of the occlusion member 141 and a second position different from the first position corresponding to the second configuration of the occlusion member 141. In some embodiments, the actuator may be configured for unidirectional operation. For example, the actuator may move from its first position to its second position, but may not move from its second position to its first position. In this manner, the occlusion member 140 is prevented from moving to its second configuration before its first configuration.

[0025]

[1054] 1 and 2 as moving in a transverse direction perpendicular to the length of needle 120 (e.g., in the direction of arrow AA), in other embodiments, occlusion member 141 can move in any suitable manner or direction between the first and second configurations. For example, in some embodiments, occlusion member 141 can move in a rotational motion between the first and second configurations. In other embodiments, occlusion member 141 can move in a proximal or distal direction (e.g., substantially perpendicular to the direction of arrow AA).

[0026]

[1055] 1 and 2, in some embodiments, the transfer device 100 and / or portions thereof may be included within any suitable transfer device or system configured to withdraw a sample of bodily fluid from a patient and / or to deliver fluid parenterally to a patient. For example, in some embodiments, the transfer device 100 and / or portions thereof may be included within any of the transfer devices described in co-pending U.S. Provisional Patent Application No. 61 / 947,076, filed March 3, 2014, entitled "Apparatus and Methods for Disinfection of a Specimen Container," U.S. Patent Application No. 14 / 096,826, filed December 4, 2013, entitled "Sterile Bodily-Fluid Collection Device and Methods," or U.S. Patent No. 8,535,241, filed October 12, 2012, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," the entire contents of which are incorporated herein by reference. Thus, transfer device 100 may be used in conjunction with any suitable transfer device to withdraw a sample of bodily fluid from a patient and / or deliver fluid parenterally to a patient with reduced contamination from, for example, skin-resident microorganisms, unwanted body tissue, etc.

[0027]

[1056] 3-5 illustrate a fluid transfer device 200 (also referred to herein as a "transfer device") according to one embodiment. The transfer device 200 includes a housing 201, a needle 220, and an occlusion mechanism 240. The needle 220 has a proximal portion 221 and a distal portion 222 defining a lumen 223 therebetween. As described above with reference to FIGS. 1 and 2, the proximal portion 221 of the needle 220 is physically and fluidly coupled to the distal portion 203 of the housing 201. As described in more detail herein, the distal portion 222 is configured to be inserted into a patient such that fluid may be transferred to or from the patient through the lumen 223 of the needle 220.

[0028]

[1057] The housing 201 includes a proximal portion 202, a distal portion 203, and an intermediate portion 204. As shown in FIG. 3, the housing 201 may have an overall shape substantially similar to a known butterfly needle. The housing 201 may be of any suitable shape, size, or configuration. For example, while shown in FIG. 3 as being substantially cylindrical, the housing 201 may be square, rectangular, polygonal, and / or any other non-cylindrical shape. In this manner, the overall shape of the housing 201 may facilitate handling of the delivery device 201 by including geometric features similar to known butterfly needles. As described above, the distal portion 203 of the housing 201 may be physically and fluidly coupled to the proximal portion 221 of the needle 220. The proximal portion 202 may be coupled to a cannula 205. For example, as shown in FIGS. 4 and 5, a portion of the cannula 205 may be disposed within an opening 207 defined by the proximal portion 202 of the housing 201. When positioned within opening 207, cannula 205 may be physically and fluidly coupled to intermediate portion 204 of housing 201. More specifically, when cannula 205 is physically and fluidly coupled to intermediate portion 204 of housing 201, cannula 205 defines a lumen 209 that is in fluid communication with a fluid flow path 208 defined by intermediate portion 204 of housing 201.

[0029]

[1058] The intermediate portion 204 of the housing 201 includes a port 206 that can be coupled to and / or receive a portion of the occlusion mechanism 240. Additionally, the occlusion mechanism 240 can be, for example, a stylet including an engagement member 247 coupled to the occlusion member 241. As shown in FIG. 4, a portion of the occlusion member 241 is disposed within an opening 210 defined by the port 206 to bring the engagement member 247 into contact with the port 206. The engagement member 247 can be coupled to the port 206 in any suitable manner. For example, in some embodiments, a surface of the engagement member 247 and a surface of the port can form a threaded coupling, a press fit (i.e., a friction fit), a snap fit, any number of mating recesses, or the like. As described in more detail herein, the occlusion mechanism 240 can be moved between a first configuration associated with the first configuration of the delivery device 200 (see, e.g., FIG. 4) and a second configuration associated with the second configuration of the delivery device 200 (see, e.g., FIG. 5).

[0030]

[1059] 4, when engagement member 247 of occlusion mechanism 240 is coupled to port 206 (e.g., in a first configuration), proximal portion 242 of occlusion member 241 may be disposed within opening 210 and occlusion member 241 may extend into lumen 223 defined by fluid flow passage 208 of housing 201 and needle 220. More specifically, occlusion member 241 may extend into lumen 223 of needle 220 such that distal portion 243 of occlusion member 241 is substantially aligned with distal portion 222 of needle 220. In other words, a distal surface of occlusion member 241 may be substantially parallel and aligned (e.g., coplanar) with a distal surface of needle 220.

[0031]

[1060] The occlusion member 241 may be configured such that an outer surface of the occlusion member 241 contacts an inner surface of the needle 220 that defines the lumen 223. In this manner, the outer surface of the occlusion member 241 and the inner surface of the needle 220 may form a friction fit. In other words, an outer diameter of at least the distal portion 243 of the occlusion member 240 may be slightly larger than an inner diameter of at least the distal portion 222 of the needle 220. Thus, the occlusion member 241 and the needle 220 may form a friction fit (at least at the distal portion 222 of the needle 220). Thus, when the distal portion 243 of the occlusion member 241 is aligned with the distal portion 222 of the needle 220, the lumen 223 is substantially fluidly isolated from a volume outside the needle 220 (e.g., a volume disposed proximally relative to the needle 220). In other words, the lumen 223 of the needle 220 is occluded by the occlusion member 241.

[0032]

[1061] In use, the transfer device 200 can be in a first configuration (FIG. 4) and the proximal portion of the cannula 205 can be physically and fluidly coupled to a fluid reservoir (not shown). The fluid reservoir can be any suitable fluid reservoir, such as, for example, any known fluid reservoir configured to receive bodily fluids from a patient and / or deliver parenteral fluids to a patient. In some embodiments, the fluid reservoir can be, for example, any of the containers, vials, bottles, reservoirs, etc. described above with reference to Vacutainer®, BacT / ALERT® SN, BacT / ALERT® FA and / or the fluid reservoir 130 of FIGS. 1 and 2. In some embodiments, the external fluid reservoir can be configured such that a negative pressure exists within the internal volume of the reservoir. In other embodiments, the fluid reservoir can contain a liquid intended to be delivered to the patient. The fluid reservoir can be coupled to the cannula 205 in any suitable manner. For example, in some embodiments, the cannula 205 can be disposed about a port of a fluid reservoir. In other embodiments, the proximal portion cannula 205 can include a Luer Lok® (not shown) configured to matingly couple to a fluid reservoir. In yet other embodiments, the proximal portion of the cannula 205 can include a piercing member (not shown) configured to pierce a pierceable septum (such as those included in a Vacutainer®).

[0033]

[1062] With the cannula 205 coupled to the fluid reservoir and the transfer device 200 and occlusion mechanism 240 in the first configuration, a user (e.g., a doctor, nurse, technician, phlebotomist, etc.) can manipulate the transfer device 200 to insert the needle 220 into a patient. In this manner, the tip portion 222 of the needle 220 can pierce the skin of the patient to position the tip portion 222 of the needle 220, for example, within a vein. In some cases, the venipuncture event (e.g., insertion of the tip portion 222 of the needle 220 into a vein) may, for example, remove skin-resident microorganisms from the insertion site. Thus, when the occlusion mechanism 240 is in the first configuration in which the occlusion member 241 occludes the lumen 223 of the needle 220, the lumen 223 is isolated from dislodged skin-resident microorganisms and / or other undesirable external contaminants that may be present on the patient's skin surface (e.g., contaminants, bacteria, fungi, yeasts, etc. from the ambient air, transferred from the medical personnel's fingers when palpating or re-palpating the patient's vein, transferred to the collection tool during assembly and / or opening of the packaging, etc.).

[0034]

[1063] With the tip portion 222 of the needle 220 positioned within the vein, the occlusion mechanism 240 can be moved to the second configuration to place the delivery device in the second configuration, as shown by arrow BB in Figure 5. For example, the engagement member 247 of the occlusion mechanism 240 can be removed (e.g., withdrawn or pulled) from the port 206 and moved in the direction of arrow BB such that the occlusion member 241 is removed from the lumen 223 of the needle 220 and the fluid flow path 208 of the housing 201. Although not shown in Figures 3-5, the intermediate portion 204 can include, for example, a self-sealing septum configured to seal an opening left by removal of the occlusion member 241. 5, with the cannula 205 fluidly coupled to a fluid reservoir (not shown), movement of the occlusion mechanism 240 to the second configuration places the lumen 223 of the needle 220 in fluid communication with the patient's vein and in fluid communication with the fluid reservoir (e.g., through the fluid flow path 208 of the housing 201 and the lumen 209 of the cannula 205). In other words, the lumen 223 of the needle 220 is substantially unoccluded such that a flow of fluid substantially free of contaminants (e.g., skin-resident microorganisms and / or other undesirable external contaminants) may be transferred to or from the patient through the lumen 223 of the needle 220, the fluid flow path 208 of the housing 201, and the lumen 209 of the cannula 205.

[0035]

[1064] 3-5, in some embodiments, transfer device 200 and / or portions thereof may be included within any suitable transfer device or system configured to withdraw a sample of bodily fluid from a patient and / or parenterally deliver to a patient a fluid that is substantially free of contamination from, for example, skin-resident microorganisms, unwanted body tissue, etc. For example, in some embodiments, transfer device 200 and / or portions thereof may be included within any of the transfer devices described above with reference to transfer device 100 of FIGS.

[0036]

[1065] Although the occlusion member 240 is shown in FIG. 5 as being manually actuated from a first configuration to a second configuration, in other embodiments, the transfer device may include an occlusion mechanism having an actuator operable to move the occlusion mechanism from the first configuration to the second configuration. For example, FIGS. 6-12 show a fluid transfer device 300 (also referred to herein as a "transfer device") according to one embodiment. The transfer device 300 includes a housing 301, a needle 320, and an occlusion mechanism 340. The needle 320 has a proximal portion 321 and a distal portion 322 defining a lumen 323 therebetween. As described in more detail herein, the proximal portion 321 of the needle 320 is physically and fluidly coupled to a shuttle member 360 of the occlusion member 340. As described in more detail herein, the distal portion 322 is configured to be inserted into a patient such that fluid may be transferred to or from the patient through the lumen 323 of the needle 320.

[0037]

[1066] The housing 301 has a proximal portion 302, a distal portion 303, and an intermediate portion 304. As shown in FIG. 6, the housing 301 may have an overall shape substantially similar to the housing 201 shown and described with reference to FIG. 3. As shown in FIG. 7, the housing 301 defines an interior volume 312 between the proximal portion 302 and the distal portion 303 that substantially encloses and / or contains the occlusion mechanism 340 and the biasing member 370. The proximal portion 302 and the distal portion 303 of the housing 301 are substantially open. In this manner, the distal portion 303 can receive the proximal portion 321 of the needle 320, which can then be physically and fluidly coupled to the distal portion 362 of the shuttle member 360. The proximal portion 302 can receive a portion of the cannula 305, which can then be physically and fluidly coupled to the proximal portion 361 of the shuttle member 360. 6 and 7, and as described in more detail herein, the housing 301 also defines a slot 311 that can movably receive the retracted portion 365 of the shuttle member 360 as the occlusion mechanism 340 moves between the first and second configurations. Thus, while the occlusion mechanism 340 is disposed within an interior volume 312 of the housing 301, the overall size of the housing 301 can still be substantially similar to, for example, known butterfly needles.

[0038]

[1067] The occlusion mechanism 340 includes an occlusion member 341 and a shuttle member 360. As described above, a distal portion 362 of the shuttle member 360 is physically and fluidly coupled to a proximal portion 321 of the needle 320. The needle 320 may be coupled to the shuttle member 360 in any suitable manner, for example, as described above with reference to FIGS. 1 and 2. In other embodiments, at least a portion of the shuttle member 360 may be integrally formed with the needle 320. For example, in some embodiments, at least a portion of the shuttle 360 ​​and the needle 320 may be formed from a thermoplastic, as described above with reference to FIGS. 1 and 2. In such embodiments, the needle 320 may be, for example, a cannula having a sharpened tip.

[0039]

[1068] As shown in FIG. 7, the shuttle member 360 includes a flange 363 that may contact a biasing member 370 (e.g., a spring, etc.) disposed within the interior volume 312 of the housing 301. More specifically, the biasing member 370 may be disposed between an interior distal surface of the housing 301 and a surface of the flange 363. In some cases, the biasing member 370 may be actuated, either directly or indirectly, to move from a first configuration (e.g., a compressed configuration) to a second configuration (e.g., an expanded configuration). In such examples, movement of the biasing member 370 biases the shuttle member 360 to move from a first position relative to the housing 301 to a second position relative to the housing 301. For example, in some embodiments, after the needle 320 and / or the occlusion member 341 are inserted into the patient's body, the shuttle member 360 may be moved relative to the housing 301 to withdraw the needle 320 and / or the occlusion member 341. Additionally, in some embodiments, housing 301 may include or be coupled to a cannula (not shown in FIGS. 6-12) that may be adjacent to needle 320. In such embodiments, needle 320 may be operable in a venipuncture event and then withdrawn (with or without occlusion member 341) when shuttle member 360 moves to a second position relative to housing 301, thereby leaving the cannula in place within the patient.

[0040]

[1069] As shown in FIGS. 7-11, the occlusion member 341 has a proximal portion 342 and a distal portion 343 and is movable between a first configuration and a second configuration. The proximal portion 342 of the occlusion member 341 is coupled to a coupling projection 366 extending from a surface of the lead-in portion 365 of the shuttle member 360. As shown in FIG. 8, the proximal portion 342 of the occlusion member 341 can be disposed within a channel defined by the coupling projection 366 to couple the occlusion member 341 to the coupling projection 366. For example, the proximal portion 342 of the occlusion member 341 can form a press fit with a surface of the coupling projection 366 that defines the channel. In some embodiments, a preload stress within the proximal portion 342 of the occlusion member 341 can maintain the proximal portion 342 in contact with the surface of the coupling projection 366 that defines the channel. Thus, as shown in FIG. 8, at least a portion of the occlusion member 341 can be wrapped around the coupling projection 366. As described in further detail herein, the occlusion member 341 can be actuated to move from the first configuration to the second configuration such that a larger portion of the occlusion member 341 is wrapped (i.e., wrapped) around the coupling protrusion 366 of the shuttle member 360.

[0041]

[1070] While in the first configuration, the distal portion 343 of the occlusion member 341 is disposed within the lumen 323 of the needle 320. As shown in FIG. 9, the occlusion member 341 may extend into the lumen 323 of the needle 320 such that the distal portion 343 of the occlusion member 341 is substantially aligned with the distal portion 322 of the needle 320. The arrangement of the occlusion member 341 and the needle 320 may be substantially similar or the same as the arrangement of the occlusion member 241 and the needle 220 described above with reference to FIGS. 4 and 5. Thus, when the distal portion 343 of the occlusion member 341 is aligned with the distal portion 322 of the needle 320, the lumen 323 is substantially fluidly isolated from a volume external to the needle 320 (e.g., a volume disposed proximally relative to the needle 320). In other words, the lumen 323 of the needle 320 is occluded by the occlusion member 341.

[0042]

[1071] In use, the transfer device 300 can be in a first configuration (FIG. 7) and the proximal portion of the cannula 305 can be physically and fluidly coupled to a fluid reservoir (not shown). The fluid reservoir can be any suitable fluid reservoir, such as, for example, those described above with reference to the fluid reservoir 130 of FIGS. 1 and 2. With the cannula 305 coupled to the fluid reservoir and the transfer device 300 and occlusion member 341 in the first configuration, a user (e.g., a doctor, nurse, technician, phlebotomist, etc.) can manipulate the transfer device 300 to insert the needle 320 into a patient. In this manner, the distal portion 322 of the needle 320 can pierce the skin of a patient to position the distal portion 322 of the needle 320, for example, within a vein. In some cases, a venipuncture event (e.g., insertion of the distal portion 322 of the needle 320 into a vein) can result in, for example, removal of skin-resident microorganisms from the insertion site. Thus, with occlusion member 341 in the first configuration in which occlusion member 341 occludes lumen 323 of needle 320, lumen 323 is isolated from dislodged skin-resident microorganisms and / or other undesirable external contaminants.

[0043]

[1072] With the distal portion 322 of the needle 320 positioned within the vein, as shown by arrows DD in FIG. 10, the occlusion member 341 can move to the second configuration, placing the delivery device 300 in the second configuration. For example, a user can manipulate an actuator (not shown in FIGS. 6-12) operable to move the occlusion member 341 from the first configuration to the second configuration. In some embodiments, the actuator can be a push button, a toggle, a slide, an electrical circuit, or any other suitable actuator. In some embodiments, a user can actuate the occlusion member 341, for example, by squeezing an area of ​​the intermediate portion 304 of the housing 301. In this manner, the occlusion member 341 can wrap around a coupling protrusion 366 of the retractable portion 365 of the shuttle member 360, as shown in FIG. 11. The wrapping action of the occlusion member 341 causes the tip portion 343 of the occlusion member 341 to move in a base end direction (e.g., in the direction of arrow DD in FIG. 10), thereby removing the tip portion 343 of the occlusion member 341 from the lumen 323 of the needle 320 (see, e.g., FIGS. 11 and 12).

[0044]

[1073] Thus, with the cannula 305 fluidly coupled to a fluid reservoir (not shown), movement of the occlusion member 341 to the second configuration places the lumen 323 of the needle 320 in fluid communication with the patient's vein and in fluid communication with the fluid reservoir. Additionally, when the occlusion member 341 is in the second configuration (e.g., the distal portion 322 is disposed within the lumen 364 of the shuttle member 360 (FIG. 11)), the proximal portion 322 of the needle 320 is physically and fluidly coupled to the shuttle member 360 (as described above) such that the lumen 323 of the needle 320 is in fluid communication with the fluid reservoir. In this manner, the lumen 323 of the needle 320 is substantially unoccluded such that a flow of fluid substantially free of contaminants (e.g., skin-resident microorganisms) may be transferred to or from the patient through the lumen 323 of the needle 320, the lumen 364 of the shuttle member 360, and the lumen 309 of the cannula 305.

[0045]

[1074] As discussed above, in some cases, once the needle 320 is positioned within the patient's vein, the user may manipulate the delivery device 300 to move the shuttle member 360 from a first position to a second position relative to the housing 301. Thus, the needle 320 and occlusion mechanism 340 may be retracted (i.e., moved in a proximal direction) relative to the housing 301. In some embodiments, the delivery device 300 may be configured such that the cannula coupled to the distal portion 303 of the housing 301 remains within the vein as the needle 320 and occlusion mechanism 340 are retracted.

[0046]

[1075] 6-12, in some embodiments, transfer device 300 and / or portions thereof may be included within any suitable transfer device or system configured to withdraw a sample of bodily fluid from a patient and / or parenterally deliver to a patient a fluid that is substantially free of contamination by, e.g., skin-resident microorganisms, unwanted body tissue, etc. For example, in some embodiments, transfer device 300 and / or portions thereof may be included within any of the transfer devices described above with reference to transfer device 100 of FIGS.

[0047]

[1076] Although with reference to Figures 6-12, the occlusion member 341 is shown and described above as being disposed within the lumen 323 of the needle 320, in other embodiments, the transfer device may include an occlusion member disposed about the needle. In other words, the needle of the transfer device may be disposed within the lumen of the occlusion member. For example, Figures 13-17 show a fluid transfer device 400 (also referred to herein as a "transfer device") according to one embodiment. The transfer device 400 includes a housing 401, a needle 420, and an occlusion mechanism 440 (also referred to herein as an "occlusion member"). The needle 420 has a proximal portion 421 and a distal portion 422 defining a lumen 423 therebetween. As described above with reference to Figures 1 and 2, the proximal portion 421 of the needle 420 is physically and fluidly coupled to the distal portion 403 of the housing 401. The tip portion 422 of the needle 420 defines a set of openings or apertures 425 disposed around the periphery of the needle 420 that fluidly connect the lumen 423 of the needle 420 to a volume external to the needle 420. More specifically, the tip portion 422 of the needle 420 has a solid (i.e., closed) tip 424 (see, e.g., FIG. 15 ) that occludes the tip of the needle 420. Thus, the openings 425 disposed around the periphery of the needle 420 fluidly connect the lumen 423 to a volume external to the needle 420, rather than the open tip surfaces of the needles 220 and 320 discussed above. In this manner, the needle 420 may be inserted into a patient such that fluids may be transferred to or from the patient through the openings 425 and lumen 423 of the needle 420, as described in further detail herein.

[0048]

[1077] The housing 401 has a proximal portion 402, a distal portion 403, and an intermediate portion 404. As shown in FIG. 13, the housing 401 may have an overall shape substantially similar to the housing 201 shown and described with reference to FIG. 3. As described above, the distal portion 403 of the housing 401 may be physically and fluidly coupled to the proximal portion 421 of the needle 420. The proximal portion 402 may be coupled to a cannula 405. For example, as shown in FIG. 14, a portion of the cannula 405 may be disposed within an opening 407 defined by the proximal portion 402 of the housing 401. As described above with reference to FIGS. 3-5, when disposed within the opening 407, the cannula 405 may be physically and fluidly coupled to the intermediate portion 404 of the housing 401. Thus, the lumen 409 defined by the cannula 405 is in fluid communication with the fluid flow path 408 defined by the intermediate portion 404 of the housing 401.

[0049]

[1078] The occlusion mechanism 440 has a proximal portion 442 and a distal portion 443 defining a lumen 444 therebetween. The occlusion mechanism 440 is disposed about a portion of the needle 420 and may be movable between a first configuration ( FIG. 14 ) and a second configuration ( FIG. 16 ). Similarly, the occlusion member (mechanism) 440 is movably disposed about the needle 420 such that at least a portion of the needle 420 is disposed within the lumen 444 of the occlusion member 440. As shown in FIGS. 14 and 15 , when in the first configuration, the distal portion 443 of the occlusion member 440 is substantially aligned with the distal portion 422 of the needle 420. In other words, when the occlusion member 440 is in the first configuration, the distal surface of the occlusion member 440 may be substantially parallel and aligned (e.g., coplanar) with the distal surface of the needle 420.

[0050]

[1079] The occlusion member 440 may be configured such that an exterior surface of the needle 420 contacts an interior surface of the occlusion member 440 that defines a lumen 444. In this manner, the interior surface of the occlusion member 440 and the exterior surface of the needle 420 may form a friction fit (e.g., an arrangement similar to that of the needle 220 and the occlusion member 221 described above with reference to FIGS. 3-5). As shown in FIG. 15, when the distal portion 443 of the occlusion member 440 is aligned with the distal portion 422 of the needle 420, the opening 425 of the needle 420 is disposed within the lumen 444 of the occlusion member 440. Thus, the lumen 423 of the needle 420 is substantially fluidly isolated from a volume external to the needle 420 (e.g., a volume disposed proximally relative to the needle 420). In other words, the opening 425 and the lumen 423 of the needle 420 are occluded by the occlusion member 440.

[0051]

[1080] In use, the transfer device 400 can be in a first configuration (FIG. 14) and the proximal portion of the cannula 405 can be physically and fluidly coupled to a fluid reservoir (not shown). The fluid reservoir can be any suitable fluid reservoir, such as, for example, those described above with reference to the fluid reservoir 130 of FIGS. 1 and 2. With the cannula 405 coupled to the fluid reservoir and the transfer device 400 in the first configuration, a user (e.g., a doctor, nurse, technician, phlebotomist, etc.) can manipulate the transfer device 400 to insert the needle 420 into a patient. In this manner, the distal portion 422 of the needle 420 can pierce the skin of the patient to position the distal portion 422 of the needle 420, for example, within a vein. In some cases, a venipuncture event (e.g., insertion of the distal portion 422 of the needle 420 into a vein) can result in, for example, removal of skin-resident microorganisms from the insertion site. Thus, with needle 420 having a closed tip 424 (FIG. 15) and occlusion member 440 occluding opening 425, lumen 423 of needle 420 is isolated from dislodged skin-resident microorganisms and / or other undesirable external contaminants.

[0052]

[1081] Once the distal portion 422 of the needle 420 is positioned within the vein, the occlusion member 440 may be moved to a second configuration to place the delivery device 400 in the second configuration, as shown by arrows EE in FIG. 16. For example, a user may slide the occlusion member 440 in the EE direction (i.e., proximal direction) along the length of the needle 420 such that the proximal portion 442 of the occlusion member 440 contacts the distal portion 403 of the housing 401. In this manner, the distal portion 443 of the occlusion member 440 may be moved to a distal position relative to the opening 425 of the needle 420, as shown in FIG. 17. Thus, the opening 425 of the needle 420 is substantially unoccluded, allowing the lumen 423 to be in fluid communication with the vein in which the needle 420 is positioned. Movement of occlusion member 440 to the second configuration thus places a fluid reservoir (not shown) in fluid communication with the patient's vein through opening 425 and lumen 423 of needle 420, fluid flow path 408 of housing 401, and lumen 409 of cannula 405. In other words, opening 425 of needle 420 is substantially unoccluded such that a flow of fluid substantially free of contaminants (e.g., skin-resident microorganisms) may be transferred to or from the patient through opening 425 and lumen 423 of needle 420, fluid flow path 408 of housing 401, and lumen 409 of cannula 405.

[0053]

[1082] Although the distal portion 443 of the occlusion member 440 is shown and described in FIGS. 13-17 as being substantially aligned (e.g., flush) with the distal portion 422 of the needle 420, in other embodiments, the distal portion 443 of the occlusion member 440 can be offset from the distal tip 424 of the needle 420. For example, in some embodiments, the needle can include a distal tip having a diameter greater than the diameter of the remainder of the needle. In such embodiments, the occlusion member can define a lumen having an inner diameter that substantially matches the diameter of the remainder of the needle (e.g., other than the distal tip), and the occlusion member can have an outer diameter that substantially matches the diameter of the distal tip of the needle. Thus, when in the first configuration, the occlusion member can be disposed adjacent the distal tip such that there is a substantially smooth transition from the diameter of the distal tip to the outer diameter of the occlusion member. In some embodiments, the change in diameter from the distal tip to the remainder of the needle forms a shoulder that can be any substantially linear and can be disposed at any given angle. In other embodiments, the shoulder can be substantially non-linear. Additionally, the configuration of the distal surface of the occlusion member can be such that the distal surface of the occlusion member matingly couples with the shoulder of the needle.

[0054]

[1083] 13-17, in some embodiments, transfer device 400 and / or portions thereof may be included within any suitable transfer device or system configured to withdraw a sample of bodily fluid from a patient and / or parenterally deliver to a patient a fluid that is substantially free of contamination by, e.g., skin-resident microorganisms, unwanted body tissue, etc. For example, in some embodiments, transfer device 100 and / or portions thereof may be included within any of the transfer devices described above with reference to transfer device 400 of FIGS.

[0055]

[1084] Although in Figures 13-17 the occlusion member 440 is shown and described as translating (sliding) from a first configuration to a second configuration along the length of the needle 420, in other embodiments the transfer device may include an occlusion mechanism (occlusion member) that rotates relative to the needle to move from the first configuration to the second configuration. For example, Figures 18-22 show a fluid transfer device 500 (also referred to herein as a "transfer device") according to one embodiment. The transfer device 500 includes a housing 501, a needle 520, and an occlusion mechanism 540 (also referred to herein as an "occlusion member"). The needle 520 has a proximal portion 521 and a distal portion 522 defining a lumen 523 therebetween. As described above with reference to Figures 1 and 2, the proximal portion 521 of the needle 520 is physically and fluidly coupled to the distal portion 503 of the housing 501. The distal portion 522 of the needle 520 defines a set of openings 525 disposed along the periphery of the needle 520 that fluidly connect the lumen 523 of the needle 520 to a volume external to the needle 520. More specifically, the distal portion 522 of the needle 520 has a solid (i.e., closed) tip 524 (see, e.g., FIG. 20) that occludes the tip of the needle 520. Thus, the needle 520 may be substantially similar to the needle 520 shown and described above with reference to FIGS. 13-17. In this manner, the needle 520 may be inserted into a patient such that fluid may be transferred to or from the patient through the openings 525 and lumen 523 of the needle 520, as described in further detail herein.

[0056]

[1085] The housing 501 has a proximal portion 502, a distal portion 503, and an intermediate portion 504. As shown in FIG. 18, the housing 501 may have an overall shape substantially similar to the housing 201 shown and described with reference to FIG. 3. As described above, the distal portion 503 of the housing 501 may be physically and fluidly coupled to the proximal portion 521 of the needle 520. The proximal portion 502 may be coupled to a cannula 505. For example, as shown in FIG. 19, a portion of the cannula 505 may be disposed within an opening 507 defined by the proximal portion 502 of the housing 501. As described above with reference to FIGS. 3-5, when disposed within the opening 507, the cannula 505 may be physically and fluidly coupled to the intermediate portion 504 of the housing 501. Thus, the lumen 509 defined by the cannula 505 is in fluid communication with the fluid flow path 508 defined by the intermediate portion 504 of the housing 501.

[0057]

[1086] The occlusion mechanism 540 has a proximal portion 542 and a distal portion 543 defining a lumen 544 therebetween. The proximal portion 542 of the occlusion member 540 is disposed adjacent the distal portion 503 of the housing 501. The occlusion mechanism 540 may be disposed about a portion of the needle 520 and may be movable between a first configuration (FIG. 19) and a second configuration (FIG. 21). Similarly, the occlusion member (mechanism) 540 is movably disposed about the needle 520 such that at least a portion of the needle 520 is disposed within the lumen 544 of the occlusion member 540. As shown in FIGS. 19 and 20, when in the first configuration, the distal portion 543 of the occlusion member 540 is substantially aligned with the distal portion 522 of the needle 520 and is disposed relative to the needle 520 to occlude the opening 525. Additionally, the occlusion member 540 may be configured such that an exterior surface of the needle 520 contacts an interior surface of the occlusion member 540 that defines the lumen 544. In this manner, the interior surface of the occlusion member 540 and the exterior surface of the needle 520 may form a friction fit, as described above with reference to Figures 13-17. Thus, the lumen 523 of the needle 520 is substantially fluidly isolated from a volume external to the needle 520 (e.g., a volume disposed proximally relative to the needle 520). In other words, the opening 525 and the lumen 523 of the needle 520 are occluded by the occlusion member 540.

[0058]

[1087] In use, the transfer device 500 can be in a first configuration (FIG. 19) and the proximal portion of the cannula 505 can be physically and fluidly coupled to a fluid reservoir (not shown). The fluid reservoir can be any suitable fluid reservoir, such as, for example, those described above with reference to the fluid reservoir 130 of FIGS. 1 and 2. With the cannula 505 coupled to the fluid reservoir and the transfer device 500 in the first configuration, a user (e.g., a doctor, nurse, technician, phlebotomist, etc.) can manipulate the transfer device 500 to insert the needle 520 into a patient. In this manner, the distal portion 522 of the needle 520 can pierce the skin of the patient to position the distal portion 522 of the needle 520, for example, within a vein. In some cases, a venipuncture event (e.g., insertion of the distal portion 522 of the needle 520 into a vein) can result in, for example, removal of skin-resident microorganisms from the insertion site. Thus, with needle 520 having closed tip 524 (FIG. 20) and obstruction member 540 obstructing opening 525, lumen 523 of needle 520 is isolated from dislodged skin-resident microorganisms.

[0059]

[1088] Once the distal portion 522 of the needle 520 is positioned within the vein, the occlusion member 540 can move from a first configuration to a second configuration, as shown by arrow FF in FIG. 21, to place the delivery device 500 in the second configuration. For example, a user can rotate the occlusion member 540 in the FF direction such that the distal portion 543 of the occlusion member 540 rotates relative to the distal portion 522 of the needle 520. Additionally, the distal portion 522 of the needle 520 and the distal portion 543 of the occlusion member 540 each include an angles surface (e.g., a sharp tip). Thus, rotation of the occlusion member 540 does not align the distal surface of the needle 520 with the distal surface of the occlusion member 540. In this manner, the occlusion member 540 is substantially unoccluded (as shown in FIG. 22) so that the opening 525 of the needle 520 can be exposed by rotating the occlusion member 540, thereby placing the lumen 523 in fluid communication with the vein in which the needle 520 is positioned.

[0060]

[1089] Movement of occlusion member 540 to the second configuration fluidly connects a fluid reservoir (not shown) to the patient's vein through opening 525 and lumen 523 of needle 520, fluid flow passage 508 of housing 501, and lumen 509 of cannula 505. In other words, opening 525 of needle 520 is substantially unoccluded such that a flow of fluid substantially free of contaminants (e.g., skin-resident microorganisms) may be transferred to or from the patient through opening 525 and lumen 523 of needle 520, fluid flow passage 508 of housing 501, and lumen 509 of cannula 505, as shown by arrows GG in FIG.

[0061]

[1090] Although in FIG. 22 the needle 520 is shown as including a single opening 525 disposed around the periphery of the needle 520, in other embodiments the needle 525 may define any suitable number of openings 525 in any suitable arrangement. For example, in some embodiments the needle 520 may define more than one opening 525 along the periphery of the needle 520 (e.g., perpendicular to the length of the needle 520). In other embodiments, two or more openings 525 may be linearly arranged along the length of the needle 520 (e.g., adjacent to an existing opening 525 shown in FIG. 22). Thus, when the obstruction member 540 is rotated relative to the needle 520, the linearly aligned openings 525 may not be substantially obstructed. In still other embodiments, the openings 525 may be arranged in a non-linear arrangement.

[0062]

[1091] 18-22, in some embodiments, transfer device 500 and / or portions thereof may be included within any suitable transfer device or system configured to withdraw a sample of bodily fluid from a patient and / or parenterally deliver to a patient a fluid that is substantially free of contamination by, e.g., skin-resident microorganisms, unwanted body tissue, etc. For example, in some embodiments, transfer device 500 and / or portions thereof may be included within any of the transfer devices described above with reference to transfer device 100 of FIGS.

[0063]

[1092] Although the distal surface of the occlusion member 540 has been shown and described as being aligned (e.g., flush) with the distal surface of the needle 520 when the occlusion member 540 is in the first configuration, in other embodiments, the transfer device may include an occlusion member that at least temporarily circumscribes substantially the entire needle. For example, FIGS. 23-27 show a fluid transfer device 600 (also referred to herein as a "transfer device") according to one embodiment. The transfer device 600 includes a housing 601, a needle 620, and an occlusion mechanism 640 (also referred to herein as an "occlusion member"). The needle 620 has a proximal portion 621 and a distal portion 622 defining a lumen 623 therebetween. As described above with reference to FIGS. 1 and 2, the proximal portion 621 of the needle 620 is physically and fluidly coupled to the distal portion 603 of the housing 601. The tip portion 622 of the needle 620 defines a set of openings 625 disposed along the periphery of the needle 620 that fluidly connect the lumen 623 of the needle 620 with a volume exterior to the needle 620. The tip portion 622 also defines a recess 626 that may be configured to retain at least a portion of skin that may be removed during a venipuncture event. In this manner, the needle 620 may be inserted into a patient such that fluids may be transferred to or from the patient through the openings 625 and lumen 623 of the needle 620, as described in further detail herein.

[0064]

[1093] Housing 601 has a proximal portion 602, a distal portion 603, and an intermediate portion 604. As shown in FIG. 23, housing 601 may have an overall shape substantially similar to housing 201 shown and described with reference to FIG. 3. As described above, distal portion 603 of housing 601 may be physically and fluidly coupled to proximal portion 621 of needle 620. Proximal portion 602 may be coupled to cannula 605. For example, as shown in FIG. 24, a portion of cannula 605 may be disposed within opening 607 defined by proximal portion 602 of housing 601. As described above with reference to FIGS. 3-5, when disposed within opening 607, cannula 605 may be physically and fluidly coupled to intermediate portion 604 of housing 601. Thus, lumen 609 defined by cannula 605 is in fluid communication with fluid flow path 608 defined by intermediate portion 604 of housing 601.

[0065]

[1094] The occlusion mechanism 640 has a proximal portion 642 and a distal portion 643 defining a lumen 644 therebetween. The proximal portion 642 of the occlusion member 640 may be coupled to the intermediate portion 604 of the housing 601. The distal portion 643 of the occlusion member 640 includes a set of gripping portions 645 that may selectively seal the distal portion 622 of the needle 620. As described in further detail herein, the distal portion 643 defines a set of openings 646 that may be selectively aligned with the openings 625 of the needle 620. In this manner, the occlusion mechanism 640 may be disposed about the needle portion 620 and may be movable between a first configuration (FIG. 23), a second configuration (FIGS. 24 and 25), and a third configuration (FIGS. 26 and 27). Similarly, the occlusion member (mechanism) 640 may be movably disposed about the needle 620 such that the needle 620 is at least temporarily disposed within the lumen 644 of the occlusion member 640.

[0066]

[1095] As shown in FIG. 23, when in the first configuration, the gripping portion 645 of the occlusion member 640 seals against the distal portion 622 of the needle 620. In use, the proximal portion of the cannula 605 may be physically and fluidly coupled to a fluid reservoir (not shown). The fluid reservoir may be any suitable fluid reservoir, such as, for example, those described above with reference to the fluid reservoir 130 of FIGS. 1 and 2. With the cannula 605 coupled to the fluid reservoir and the transfer device 600 in the first configuration, a user (e.g., a doctor, nurse, technician, phlebotomist, etc.) may manipulate the transfer device 600 to move the occlusion member 640 relative to the needle 620 (as indicated by arrow HH in FIG. 24), thereby placing the occlusion member 640 in the second configuration. For example, in some embodiments, the occlusion member 640 may be formed from a relatively flexible material that may include at least a portion that may be deformed (e.g., a bellows portion, etc.). Thus, distal end portion 643 of occlusion member 640 can move in a proximal direction (ie, in the HH direction) relative to distal end portion 622 of needle 620.

[0067]

[1096] As shown in FIG. 25 , proximal movement of the distal portion 643 of the occlusion member 640 is such that the gripping portion 645 moves to an open configuration, exposing the distal portion 622 of the needle 620. Additionally, the opening 646 of the occlusion member 640 moves to a proximal position relative to the opening 625 defined by the needle 620. Thus, the opening 625 of the needle 620 is substantially blocked by the occlusion member 640. With the occlusion member 640 in the second configuration, the user can manipulate the delivery device 600 to insert the needle 620 into the patient. In this manner, the distal portion 622 of the needle 620 can pierce the skin of the patient to position the distal portion 622 of the needle 620, for example, within a vein. In some cases, a venipuncture event (e.g., insertion of the distal portion 622 of the needle 620 into a vein) can remove a portion of the skin from the insertion site, which may include, for example, skin-resident microorganisms. Thus, with tip portion 622 of needle 620 forming recess 626, the removed skin (e.g., a skin "slice") may be disposed within recess 626. Furthermore, with occlusion member 640 occluding opening 625, lumen 623 of needle 620 is isolated from the removed skin-resident microorganisms.

[0068]

[1097] As shown by arrow II in FIG. 26, once the distal portion 622 of the needle 620 is positioned within the vein, the occlusion member 640 can be moved from the second configuration to a third configuration. In some embodiments, the third configuration can be substantially similar to the first configuration. For example, the distal portion 643 of the occlusion member 640 can be moved in a distal direction (i.e., direction II) such that the gripping portion 645 is repositioned around the distal portion 622 of the needle 620. In this manner, the removed skin section can be substantially held within the recess 626 of the needle 620 by the gripping portion 645 of the occlusion member 640. Additionally, the opening 646 of the occlusion member 640 can be realigned with the opening 625 of the needle 620, as shown in FIG. 27. Movement of occlusion member 640 from the second configuration to the third configuration thus fluidly connects a fluid reservoir (not shown) to the patient's vein through opening 646 of occlusion member 640, opening 625 and lumen 623 of needle 620, fluid flow passage 608 of housing 601, and lumen 609 of cannula 605. In other words, opening 625 of needle 620 is substantially unobstructed such that a flow of fluid substantially free of contaminants (e.g., skin-resident microorganisms) may be transferred to or from the patient through opening 646 of occlusion member 640, opening 625 and lumen 623 of needle 620, fluid flow passage 608 of housing 601, and lumen 609 of cannula 605.

[0069]

[1098] 23-27, in some embodiments, transfer device 600 and / or portions thereof may be included within any suitable transfer device or system configured to withdraw a sample of bodily fluid from a patient and / or parenterally deliver to a patient a fluid that is substantially free of contamination by, e.g., skin-resident microorganisms, unwanted body tissue, etc. For example, in some embodiments, transfer device 600 and / or portions thereof may be included within any of the transfer devices described above with reference to transfer device 100 of FIGS.

[0070]

[1099] While the transfer devices 200, 300, 400, 500, and 600 described above include an occlusion member (e.g., occlusion members 241, 341, 440, 540, and 640), in other embodiments, the transfer device may include a needle or the like that is convertible between a first, occluding configuration and a second, non-occluding configuration. For example, FIGS. 28-30 show a fluid transfer device 700 (also referred to herein as a "transfer device") according to one embodiment. The transfer device 700 includes a housing 701 and a needle 720. The housing 701 has a proximal portion 702, a distal portion 703, and an intermediate portion 704. As shown in FIG. 28, the housing 701 may have an overall shape substantially similar to the housing 201 shown and described with reference to FIG. 3. As described in more detail herein, the distal portion 703 of the housing 701 may be physically and fluidly coupled to a proximal portion (not shown) of the needle 720. Proximal portion 702 may be coupled to a cannula 705. For example, a portion of cannula 705 may be disposed within an opening (not shown) defined by proximal portion 702 of housing 701. As described above with reference to Figures 3-5, when disposed within the opening (not shown), cannula 705 may be physically and fluidly coupled to intermediate portion 704 of housing 701. Thus, a lumen (not shown) defined by cannula 705 is in fluid communication with a fluid flow path (not shown) defined by intermediate portion 704 of housing 701.

[0071]

[1100] The needle 720 has a proximal portion (not shown) and a distal portion 722 defining a lumen 723 therebetween. As described above with reference to FIGS. 1 and 2, the proximal portion (not shown) of the needle 720 is physically and fluidly coupled to the distal portion 703 of the housing 701. The distal portion 722 of the needle 720 includes a distal tip 724 that may be convertible between a first configuration (FIG. 29) and a second configuration (FIG. 30). For example, in some embodiments, at least the distal portion 720 of the needle may be formed from a shape memory alloy such as Nitinol or the like. In this manner, the distal tip 724 of the needle 720 may be configured to convert from a first configuration to a second configuration when exposed to a particular condition, e.g., when heated to a particular temperature, when wet, etc. In this manner, when in the first configuration, the distal tip 724 of the needle 720 may be substantially closed, and when exposed to a particular condition, the distal tip 724 may be convertible to an open configuration (e.g., the second configuration).

[0072]

[1101] In use, the transfer device 700 can be in a first configuration (FIG. 29) and the proximal portion of the cannula 705 can be physically and fluidly coupled to a fluid reservoir (not shown). The fluid reservoir can be any suitable fluid reservoir, such as, for example, those described above with reference to the fluid reservoir 130 of FIGS. 1 and 2. With the cannula 705 coupled to the fluid reservoir and the transfer device 700 in the first configuration, a user (e.g., a doctor, nurse, technician, phlebotomist, etc.) can manipulate the transfer device 700 to insert the needle 720 into a patient. In this manner, the distal portion 722 of the needle 720 can pierce the skin of the patient and the distal portion 722 of the needle 720 can be positioned, for example, within a vein. In some cases, a venipuncture event (e.g., insertion of the distal portion 722 of the needle 720 into a vein) can result in, for example, removal of skin-resident microorganisms from the insertion site. Thus, with the needle 720 in the first configuration, the distal tip 724 is substantially closed such that the lumen 723 is substantially occluded (FIG. 29). In this manner, when the needle 720 is inserted into a patient, the lumen 723 of the needle 720 is isolated from the removed skin-resident microorganisms. Once the distal portion 722 of the needle 720 is positioned within a vein, the distal tip 724 can be converted from the first configuration to a second configuration (FIG. 30). Thus, the distal tip 724 is converted to an open configuration, fluidly connecting the lumen 723 to the vein in which the needle 720 is positioned. Additionally, movement of the distal tip 724 to the second configuration fluidly connects a fluid reservoir (not shown) to the patient's vein through the lumen 723 of the needle 720, the fluid flow path (not shown) of the housing 701, and the lumen of the cannula 705 (not shown). In other words, the lumen 723 of the needle 720 is substantially unobstructed so that a flow of fluid substantially free of contaminants (e.g., skin-resident microorganisms) may be transferred to or from the patient through the lumen 723 of the needle 720, the fluid flow path (not shown) of the housing 701, and the lumen of the cannula 705 (not shown).

[0073]

[1102] Although needle 720 is described above as being formed from a reconfigurable material, in other embodiments, needle 720 may include a coating or the like that is convertible from a first configuration to a second configuration. For example, in some embodiments, needle 720 may be coated with a material that may dissolve upon contact with fluid (e.g., when placed within a patient's vein).

[0074]

[1103] 28-30, in some embodiments, transfer device 700 and / or portions thereof may be included within any suitable transfer device or system configured to withdraw a sample of bodily fluid from a patient and / or parenterally deliver to a patient a fluid that is substantially free of contamination by, e.g., skin-resident microorganisms, unwanted body tissue, etc. For example, in some embodiments, transfer device 700 and / or portions thereof may be included within any of the transfer devices described above with reference to transfer device 100 of FIGS.

[0075]

[1104] 31 is a flow chart illustrating a method 890 of transferring fluid to or from a patient using a parenteral fluid transfer device, according to one embodiment. The parenteral fluid transfer device may be any suitable transfer device described herein (e.g., transfer devices 100, 200, 300, 400, 500, 600, and / or 700). Thus, a parenteral fluid transfer device (also referred to herein as a "transfer device") includes at least a needle and an occlusion mechanism. The needle can define a lumen and is configured to be inserted into a patient. The occlusion mechanism is operable to selectively control the flow of fluid to or from the patient through the needle lumen.

[0076]

[1105] Method 890 includes the step of placing an occlusion mechanism in a first configuration at 891 such that the lumen of the needle is occluded to prevent tissue or other undesirable external contaminants from entering the lumen. For example, in some embodiments, the occlusion mechanism may include an occlusion member disposed within a portion of the lumen of the needle such that at least a portion of the lumen is fluidly isolated from a distal portion of the occlusion member (e.g., as described above with reference to delivery device 200 (FIGS. 3-5) and delivery device 300 (FIGS. 6-12)). In other embodiments, the occlusion member may be disposed about the needle and positioned to occlude an opening and / or port defined by the needle (e.g., as described above with reference to delivery device 400 (FIGS. 13-17), delivery device 500 (FIGS. 18-22) and / or delivery device 600 (FIGS. 23-27)). In still other embodiments, a portion of the needle may form and / or define the occlusion member (e.g., as described above with reference to delivery device 700 (FIGS. 28-30)).

[0077]

[1106] While in the first configuration, the needle is inserted into the patient at 892. In this manner, the distal portion of the needle may pierce the patient's skin to position the distal portion of the needle, for example, within a vein. In some cases, the venipuncture event (e.g., insertion of the distal portion of the needle into a vein) may, for example, remove skin-resident microorganisms from the insertion site. In other instances, as discussed above, external contaminants and microorganisms may be present on the patient's skin. Thus, with the occlusion mechanism in the first configuration with the occlusion member occluding the needle lumen, the lumen is isolated from the removed skin-resident microorganisms and / or other undesirable external contaminants.

[0078]

[1107] After the needle is inserted into the patient, the occlusion mechanism is moved to a second configuration at 893 in which the lumen of the needle is unobstructed and allows for fluid transfer to or from the patient. For example, the occlusion member can be translated, rotated, converted, dissolved, and / or otherwise reconfigured from the first configuration to the second configuration. In this manner, the occlusion member can be moved relative to the needle such that the lumen is substantially unobstructed. In some embodiments, the occlusion member can be moved manually from the first configuration to the second configuration. In other embodiments, the occlusion member can be moved or converted automatically from the first configuration to the second configuration. In still other embodiments, the user can operate an actuator or the like operable to move or convert the occlusion member from the first configuration to the second configuration.

[0079]

[1108] In some embodiments, the needle and / or any other suitable portion of the transfer device may be physically and fluidly coupled to a fluid reservoir (not shown). The fluid reservoir may be any suitable fluid reservoir, such as, for example, any known fluid reservoir configured to collect and / or deliver parenteral fluids. Thus, fluid may be transferred between the patient and the fluid reservoir. In some cases, the embodiments and methods described herein may be used with fluid transfer devices such as those described in U.S. Pat. No. 8,535,241, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed October 12, 2012, and U.S. Provisional Patent Application No. 61 / 712,468, entitled "Systems and Methods for Delivering a Fluid to a Patient With Reduced Contamination," filed October 11, 2012, the entire contents of which are incorporated herein by reference. In such instances, occluding the needle lumen as shown and described by the embodiments and methods herein reduces the amount (e.g., concentration and / or volume ratio) of contaminants, such as, for example, skin-resident microorganisms, contained within the aliquot volume. Thus, the aliquot volume drawn prior to drawing the sample volume may be reduced. Furthermore, the sample volume drawn through the needle lumen after the aliquot volume has been collected may, in some cases, be substantially free of contaminants, etc., that may lead to false positive or false negative results when testing the sample volume.

[0080]

[1109] Although various embodiments have been described above, it should be understood that they are presented by way of example only and not limitation. Where the methods and steps described above show certain events occurring in a particular order, those skilled in the art having the benefit of this disclosure will recognize that the order of certain steps may be altered and that such alterations are in accordance with variations of the invention. Furthermore, where possible, certain of the steps may be performed simultaneously in a parallel process or may be performed sequentially as described above. Additionally, certain steps may be partially completed before proceeding to the next step.

[0081]

[1110] While various embodiments have been specifically shown and described, various changes in form and detail may be made. For example, with respect to FIG. 21, although the occlusion member 541 has been shown and described as rotating in one direction, in other embodiments the actuator may be rotated in a first direction (e.g., in the direction of arrow FF in FIG. 21) and a second direction opposite the first direction. In such embodiments, rotation in the second direction may be configured to move the delivery device between the first and second configurations. In other embodiments, rotation of the actuator in the second direction may be limited.

[0082]

[1111] Although various embodiments have been described as having particular combinations of features and / or components, other embodiments are possible having any combination or subcombination of any of the features and / or components of any of the embodiments described herein.

[0083]

[1112] The specific configuration of the various components can also be modified. For example, the size and specific shape of the various components can be different from the embodiments shown while still providing the functionality described herein. More specifically, the size and shape of the various components can be specifically selected for a desired bodily fluid flow rate into the fluid reservoir or a desired parenteral fluid flow rate to the patient. Similarly, the size and / or specific shape of the various components can be specifically selected for a desired fluid reservoir. For example, some 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, etc. can be contacted with a disinfecting member to sterilize one or more interfaces associated therewith before bodily fluid is drawn into the volume thus defined.

Claims

1. 1. A device for parenterally transferring fluids to or from a patient, comprising: a needle having a distal portion and a proximal portion, defining a lumen between the distal portion and the proximal portion, the distal portion having a beveled distal surface for insertion into the patient, the distal portion defining an opening along a circumference of the needle in fluid communication with the lumen; an occlusion member having a beveled leading surface, the leading surface of the occlusion member being flush with a leading surface of the needle when the occlusion member is in a first position relative to the needle such that the opening of the needle is blocked by the occlusion member, and the leading surface of the occlusion member being non-flush with the leading surface of the needle when the occlusion member is in a second position relative to the needle such that the opening of the needle is not blocked by the occlusion member; A device comprising:

2. The device of claim 1 , wherein the obstruction member covers the opening when in the first position and does not cover the opening when in the second position.

3. the tip surface of the needle is a closed beveled tip surface; The device of claim 1 , wherein the leading surface of the obstruction member is an open, beveled leading surface.

4. The device of claim 3 , wherein the occlusion member is movably disposed on the needle.

5. The device of claim 3 , wherein the opening along the periphery of the needle is proximal to the closed beveled tip surface of the needle.

6. At least a portion of the distal surface of the obstruction member in the first position is distal to the opening; The device of claim 5 , wherein the at least a portion of the distal surface of the obstruction member in the second position is proximal to the opening.

7. The device of claim 1 , wherein the occlusion member is configured to translate along a length of the needle between the first position and the second position.

8. The device of claim 7 , wherein the distal surface of the occlusion member in the second position is offset from the distal surface of the needle.

9. the tip surface of the needle is a beveled tip surface that is planar; The device of claim 7 , wherein the distal surface of the obstruction member is a beveled distal surface that is planar.

10. the occlusion member is configured to rotate relative to the needle between the first position and the second position; The device of claim 1 , wherein the leading surface of the occlusion member in the second position is non-parallel to the leading surface of the needle.

11. 1. A device for parenterally transferring fluids to or from a patient, comprising: a needle having a distal portion and a proximal portion, defining a lumen between the distal portion and the proximal portion, the distal portion having a beveled distal surface for insertion into the patient, the distal portion defining an opening along a circumference of the needle in fluid communication with the lumen; an occlusion member having a beveled leading edge surface that is flush with a leading edge surface of the needle when the occlusion member is in a first position and that is not flush with the leading edge surface of the needle when the occlusion member is in a second position, the occlusion member blocking the opening of the needle in the first position and not blocking the opening of the needle in the second position; A device comprising:

12. The device of claim 11 , wherein the obstruction member covers the opening when in the first position and does not cover the opening when in the second position.

13. the tip surface of the needle is a closed beveled tip surface; The device of claim 11 , wherein the leading surface of the obstruction member is an open, beveled leading surface.

14. The device of claim 13 , wherein the occlusion member is movably disposed on the needle.

15. The device of claim 13 , wherein the opening along the periphery of the needle is proximal to the closed beveled tip surface of the needle.

16. At least a portion of the distal surface of the obstruction member in the first position is distal to the opening; The device of claim 15 , wherein the at least a portion of the distal surface of the obstruction member in the second position is proximal to the opening.

17. The device of claim 11 , wherein the occlusion member is configured to translate along a length of the needle between the first position and the second position.

18. 20. The device of claim 17, wherein the leading surface of the occlusion member in the second position is offset from the leading surface of the needle.

19. the tip surface of the needle is a beveled tip surface that is planar; The device of claim 17 , wherein the leading surface of the obstruction member is a beveled leading surface that is planar.

20. the occlusion member is configured to rotate relative to the needle between the first position and the second position; The device of claim 11 , wherein the tip surface of the occlusion member in the second position is non-parallel to the tip surface of the needle.

21. 1. A device for parenterally transferring fluids to or from a patient, comprising: a needle having a distal portion and a proximal portion, defining a lumen between the distal portion and the proximal portion, the distal portion having a beveled distal surface for insertion into the patient, the distal portion defining an opening along a circumference of the needle in fluid communication with the lumen; an obturator having an angled leading surface, the obturator being movable between a first position in which the leading surface is coplanar such that the obturator obturates the opening, and a second position in which the leading surface is not coplanar such that the obturator does not obturate the opening; A device comprising:

22. 22. The device of claim 21, wherein the obstruction member covers the opening when in the first position and does not cover the opening when in the second position.

23. the tip surface of the needle is a closed beveled tip surface; 22. The device of claim 21, wherein the leading surface of the obstruction member is an open, beveled leading surface.

24. The device of claim 23 , wherein the occlusion member is movably disposed on the needle.

25. 24. The device of claim 23, wherein the opening along the periphery of the needle is proximal to the closed beveled tip surface of the needle.

26. At least a portion of the distal surface of the obstruction member in the first position is distal to the opening; 26. The device of claim 25, wherein the at least a portion of the distal surface of the obstruction member in the second position is proximal to the opening.

27. 22. The device of claim 21, wherein the occlusion member is configured to translate along a length of the needle between the first position and the second position.

28. 28. The device of claim 27, wherein the leading surface of the occlusion member in the second position is offset from the leading surface of the needle.

29. the tip surface of the needle is a beveled tip surface that is planar; 28. The device of claim 27, wherein the leading surface of the obstruction member is a beveled leading surface that is planar.

30. the occlusion member is configured to rotate relative to the needle between the first position and the second position; 22. The device of claim 21, wherein the leading surface of the occlusion member in the second position is non-parallel to the leading surface of the needle.

Images