Embodiments described herein relate generally to transferring fluid to or from a patient, and more particularly to devices and methods for transferring fluid to or from a patient with reduced contamination from microbes or other contaminants exterior to the body and/or the fluid source, such as dermally residing microbes.
Human skin is normally habituated in variable small amounts by certain bacteria such as coagulase-negative Staphylococcus species, Proprionobacterium acnes, Micrococcus species, Streptococci Viridans group, Corynebacterium species, and Bacillus species. These bacteria for the most part live in a symbiotic relationship with human skin but in some circumstances can give rise to serious infections in the blood stream known as septicemia. Septicemia due to these skin residing organisms is most often associated with an internal nidus of bacterial growth at the site of injured tissue, for example a damaged, scarred heart valve, or a foreign body (often an artificial joint, vessel, or valve). Furthermore, there are predisposing factors to these infections such as malignancy, immunosuppression, diabetes mellitus, obesity, rheumatoid arthritis, psoriasis, and advanced age. In some instances, these infections can cause serious illness and/or death. Moreover, these infections can be very expensive and difficult to treat and often can be associated with medical related legal issues.
In general medical practice, blood is drawn from veins (phlebotomy) for two main purposes; (1) donor blood in volumes of approximately 500 mL is obtained for the treatment of anemia, deficient blood clotting factors including platelets and other medical conditions; and (2) smaller volumes (e.g., from a few drops to 10 mL or more) of blood are obtained for testing purposes. In each case, whether for donor or testing specimens, a fluid communicator (e.g., catheter, cannula, needle, etc.) is used to penetrate and enter a vein (known as venipuncture) enabling the withdrawal of blood into a tube or vessel apparatus in the desired amounts for handling, transport, storage and/or other purposes. The site of venipuncture, most commonly the antecubital fossa, is prepared by cleansing with antiseptics to prevent the growth of skin residing bacteria in blood withdrawn from the vein. It has been shown that venipuncture needles dislodge fragments of skin including hair and sweat gland structures as well as subcutaneous fat and other adnexal structures not completely sterilized by skin surface antisepsis. These skin fragments can cause septicemia in recipients of donor blood products, false positive blood culture tests, and other undesirable outcomes. Furthermore, methods, procedures and devices are in use, which divert the initial portion of venipuncture blood enabling exclusion of these skin fragments from the venipuncture specimen in order to prevent septicemia in recipients of donor blood products, false positive blood culture tests and other undesirable outcomes.
Venipuncture is also the most common method of accessing the blood stream of a patient to deliver parenteral fluids into the blood stream of patients needing this type of medical treatment. Fluids in containers are allowed to flow into the patient's blood stream through tubing connected to the venipuncture needle or through a catheter that is placed into a patient's vasculature (e.g. peripheral IV, central line, etc.). During this process, fragments of incompletely sterilized skin with viable skin residing microbes can be delivered into the blood stream with the flow of parenteral fluids and/or at the time of venipuncture for introduction and insertion of a peripheral catheter. These fragments are undesirable in the blood stream and their introduction into the blood stream of patients (whether due to dislodging of fragments by venipuncture needle when inserting a catheter or delivered through tubing attached to needle or catheter) is contrary to common practices of antisepsis. Further, these skin fragments with viable microbes can be associated with a well-known phenomenon of colonization by skin residing organisms of the luminal surface of tubing and tubing connectors utilized to deliver parenteral fluids. The colonization is not typically indicative of a true infection but can give rise to false positive blood culture tests, which may result in antibiotic treatment, laboratory tests, and replacement of the tubing apparatus with attendant patient risks and expenses all of which are unnecessary. Furthermore, the risk of clinically significant serious infection due to skin residing organisms is increased.
As such, a need exists for improved fluid transfer devices, catheter introduction techniques and devices, as well as methods for transferring fluid to or from a patient with reduced microbial contamination and inadvertent injection of undesirable external microbes into a patient's blood stream.
Devices and methods for delivering a fluid to a patient and/or introducing a peripheral catheter with reduced contamination from dermally residing microbes or other contaminants exterior to the body are described herein. 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 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. The needle defines a lumen between the proximal end portion and the distal end portion. The occlusion mechanism is operable to selectively control 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 has been inserted into the patient allowing fluid transfer to or from the patient.
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 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. The needle defines a lumen between the proximal end portion and the distal end portion. The occlusion mechanism is operable to selectively control 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 has been inserted into the patient allowing fluid transfer to or from the patient.
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 end portion that is configured to be fluidically coupled to a fluid reservoir and a distal end portion that is configured to be inserted into the patient. The needle defines a lumen between the proximal end portion and the distal end portion. The occlusion mechanism is operable to selectively control a fluid flow between the patient and the fluid reservoir. The occlusion mechanism has 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 has been 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 end portion of the needle is inserted into the patient.
In some embodiments, a method for transferring a fluid to or from a patient uses a parenteral transfer device that has 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 fluid flow to or from the patient through the lumen of the needle. The method includes disposing the occlusion mechanism in a first configuration in which the lumen of the needle is obstructed to prevent tissue, bodily fluid, and contaminants from entering the lumen. The method includes inserting the needle into the patient and, after the needle has been inserted into the patient, moving the occlusion mechanism to a second configuration in which the lumen of the needle is unobstructed to allow fluid transfer to or from the patient.
As referred to herein, “bodily fluid” can include any fluid obtained from a body of a patient, including, but not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, and the like, or any combination thereof.
As used herein, the term “set” can refer to multiple features or a singular feature with multiple parts. For example, when referring to set of walls, the set of walls can be considered as one wall with distinct portions, or the set of walls can be considered as multiple walls. Similarly stated, a monolithically constructed item can include a set of walls. Such a set of walls can include, for example, multiple portions that are in discontinuous from each other. A set of walls can also be fabricated from multiple items that are produced separately and are later joined together (e.g., via a weld, an adhesive or any suitable method).
As used in this specification, the words “proximal” and “distal” refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device.
As shown in
Similarly, the housing 101 is fluidically coupled to the fluid reservoir 130. In some embodiments, the proximal end portion of the housing 101 can include a port or lock mechanism (e.g., a Luer-Lok®) that can engage a portion of the fluid reservoir 130 to physically and fluidically couple the housing 101 to the fluid reservoir 130. In other embodiments, the housing 101 can be coupled to intervening structure such as, for example, a cannula that is configured to fluidically couple the housing 101 to the fluid reservoir 130. While shown in
The needle 120 of the transfer device 100 has a proximal end portion 121 and a distal end portion 122 and defines the lumen 123 therebetween. The proximal end portion 121 can physically and fluidically couple the needle 120 to the housing 101 (e.g., it can be the lock mechanism as described above). In some embodiments, a portion of the housing 101 can be formed about the proximal end 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 or the like) or engineered plastics (e.g. polymers, thermoplastics, glass-filled polymers, carbon-filled polymers, ceramic-based polymers, etc.) and the housing 101 can be formed from thermoplastics (e.g., polyethylene, polypropylene, polyamide, polycarbonate, silicone, urethane and silicon/urethane copolymer (hybrid) materials or the like). In such embodiments, the housing 101 can be, for example, over-molded about the proximal end portion 121 of the needle 120 to fixedly couple the needle 120 to the housing 101.
The distal end portion 122 of the needle 120 can be inserted into a portion of a patient to deliver a fluid to or receive a fluid from the patient. For example, in some embodiments, the distal end portion can include a tip with a sharp point (e.g., a beveled tip) configured to pierce a portion of the patient to dispose the distal end portion 122 within, for example, a vein. In other embodiments, a piercing member (e.g., a lumen defining needle) can be movably disposed within the needle 120 to facilitate the insertion of the distal end portion 120 into the portion of the patient (e.g., a trocar). In some embodiments, at least a portion (e.g., the distal end portion) of the needle 120 can include an antibiotic formulated to kill bacteria dislodged during venipuncture and prevent contamination of the fluid sample and/or the patient. For example, an exterior surface of the needle 120 and/or a portion of the lumen 123 can include a coating that included that antibiotic. In some embodiments, the piercing member (e.g., a trocar) can include a coating that included that antibiotic. The distal end portion 122 of the needle 120 can define one or more openings that place the lumen 123 of the needle 120 in fluid communication with a volume outside of the needle 120. For example, in some embodiments, the distal end (e.g., the tip) is substantially open. In other embodiments, the distal end can be closed and the needle 120 can define one or more openings along the circumference of the needle 120 (i.e., along the sidewalls of the needle 120). In such embodiments, the openings can be arranged in any suitable manner. For example, in some embodiments, the openings can be linearly arranged along a length of the needle 120. In other embodiments, the openings can be arranged in a linear manner along the circumference of the needle 120 (e.g., perpendicular to the length of the needle 120). In still other embodiments, the openings can be disposed in a non-linear arrangement.
The occlusion mechanism 140 of the transfer device 100 can be included in or coupled to the housing 101. In some embodiments, the occlusion mechanism 140 can be at least partially disposed within the housing 101. The occlusion mechanism 140 can be any suitable mechanism configured to direct, obstruct, or otherwise control a flow of a fluid. More specifically, the occlusion mechanism 140 includes an occlusion member 141 that can be moved (e.g., pushed, pulled, rotated, slid, bent, or otherwise reconfigured) between a first configuration (
While in the first configuration, the occlusion member 141 can fluidically 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, once moved to the second configuration (
While the occlusion member 141 is shown in
In use, the occlusion member 141 can be in the first configuration to fluidically 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 distal end portion 122 of the needle 120 can be inserted into a portion of the patient to be disposed within, for example, a vein. In this manner, dermally residing microbes dislodged during a venipuncture event (e.g., when the needle 120 and/or the occlusion member 141 pierces the skin of the patient) are isolated from the fluid flow path 108 of the housing 101. Once the distal end portion 122 of the needle 120 is disposed within the vein, the occlusion member 141 can be moved to the second configuration, as indicated by the arrow AA in
While not shown in
While shown in
Although not shown in
The housing 201 includes a proximal end portion 202, the distal end portion 203, and a medial portion 204. As shown in
The medial portion 204 of the housing 201 includes a port 206 that can be coupled to and/or that can receive a portion of the occlusion mechanism 240. Expanding further, the occlusion mechanism 240 can be, for example, a stylet that includes an engagement member 247 that is coupled to an occlusion member 241. As shown in
As shown in
The arrangement of the occlusion member 241 can be such that an outer surface of the occlusion member 241 is in contact with 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 can form a friction fit. Said another way, the outer diameter of at least the distal end portion 243 of the occlusion member 240 can be slightly larger than the inner diameter of at least the distal end portion 222 of the needle 220, thus, the occlusion member 241 and the needle 220 can form a friction fit (at least at the distal end portion 222 of the needle 220). Therefore, when the distal end portion 243 of the occlusion member 241 is aligned with the distal end portion 222 of the needle 220 the lumen 223 is substantially fluidically isolated from a volume outside of 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 obstructed by the occlusion member 241.
In use, the transfer device 200 can be in the first configuration (
With the cannula 205 coupled to the fluid reservoir and with the transfer device 200 and the occlusion mechanism 240 in the first configuration, a user (e.g., a physician, a nurse, a technician, a phlebotomist, or the like) can manipulate the transfer device 200 to insert the needle 220 into a patient. In this manner, the distal end portion 222 of the needle 220 can pierce the skin of the patient to dispose the distal end portion 222 of the needle 220 within, for example, a vein. In some instances, the venipuncture event (e.g., the insertion of the distal end portion 222 of the needle 220 into the vein) can dislodge, for example, dermally residing microbes from the insertion point. Thus, with the occlusion mechanism 240 in the first configuration where the occlusion member 241 obstructs the lumen 223 of the needle 220, the lumen 223 is isolated from the dislodged dermally residing microbes and/or other undesirable external contaminants that may be present on a patient's skin surface (e.g. contaminants, bacteria, fungus, yeast, etc. from: ambient air, healthcare practitioner's finger transferred when palpating or re-palpating the patient's vein, transferred onto collection supplies during assembly and/or when opening packaging, etc.).
With the distal end portion 222 of the needle 220 disposed within the vein, the occlusion mechanism 240 can be moved to the second configuration to place the transfer device in the second configuration, as indicated by the arrow BB in
Although not shown in
While the occlusion member 240 is shown in
The housing 301 has a proximal end portion 302, a distal end portion 303, and a medial portion 304. As shown in
The occlusion mechanism 340 includes an occlusion member 341 and the shuttle member 360. As described above, the distal end portion 362 of the shuttle member 360 is physically and fluidically coupled to the proximal end portion 321 of the needle 320. The needle 320 can be coupled to the shuttle member 360 in any suitable manner, such as, for example, those described above with reference to
As shown in
As shown in
While in the first configuration, the distal end portion 343 of the occlusion member 341 is disposed within the lumen 323 of the needle 320. As shown in
In use, the transfer device 300 can be in the first configuration (
With the distal end portion 322 of the needle 320 disposed within the vein, the occlusion member 341 can be moved to the second configuration to place the transfer device 300 in the second configuration, as indicated by the arrow DD in
Therefore, with the cannula 305 fluidically coupled to the fluid reservoir (not shown), the movement of the occlusion member 341 to the second configuration places the lumen 323 of the needle 320 in fluid communication with the vein of the patient as well as in fluid communication with the fluid reservoir. Expanding further, the proximal end portion 322 of the needle 320 is physically and fluidically coupled to the shuttle member 360 (as described above) such that when the occlusion member 341 is in the second configuration (e.g., the distal end portion 322 is disposed within the lumen 364 of the shuttle member 360 (
As described above, in some instances, once the needle 320 is disposed within the vein of the patient, the user can manipulate the transfer device 300 to move the shuttle member 360 from the first position to the second position relative to the housing 301. Thus, the needle 320 and the occlusion mechanism 340 can be retracted (i.e., moved in the proximal direction) relative to the housing 301. In some embodiments, the arrangement of the transfer device 300 can be such that a cannula coupled to the distal end portion 303 of the housing 301 is maintained within the vein while the needle 320 and the occlusion mechanism 340 are retracted.
Although not shown in
While the occlusion member 341 is shown and described above with reference to
The housing 401 has a proximal end portion 402, the distal end portion 403, and a medial portion 404. As shown in
The occlusion mechanism 440 has a proximal end portion 442 and a distal end portion 443, and defines a lumen 444 therebetween. The occlusion mechanism 440 is disposed about a portion of the needle 420 and can be movable between a first configuration (
The arrangement of the occlusion member 440 can be such that an outer surface of the needle 420 is in contact with an inner surface of the occlusion member 440 that defines the lumen 444. In this manner, the inner surface of the occlusion member 440 and the outer surface of the needle 420 can form a friction fit (e.g., a similar arrangement to the needle 220 and the occlusion member 221 shown in described above with reference to
In use, the transfer device 400 can be in the first configuration (
Once the distal end portion 422 of the needle 420 is disposed within the vein, the occlusion member 440 can be moved to the second configuration to place the transfer device 400 in the second configuration, as indicated by the arrow EE in
While the distal end portion 443 of occlusion member 440 is shown and described in
Although not shown in
Although the occlusion member 440 is shown and described in
The housing 501 has a proximal end portion 502, the distal end portion 503, and a medial portion 504. As shown in
The occlusion mechanism 540 has a proximal end portion 542 and a distal end portion 543, and defines a lumen 544 therebetween. The proximal end portion 542 of the occlusion member 540 is disposed adjacent to the distal end portion 503 of the housing 501. The occlusion mechanism 540 is disposed about a portion of the needle 520 and can be movable between a first configuration (
In use, the transfer device 500 can be in the first configuration (
Once the distal end portion 522 of the needle 520 is disposed within the vein, the occlusion member 540 can be moved from the first configuration to the second configuration to place the transfer device 500 in the second configuration, as indicated by the arrow FF in
The movement of the occlusion member 540 to the second configuration places the fluid reservoir (not shown) in fluid communication with the vein of the patient via the openings 525 and lumen 523 of the needle 520, the fluid flow path 508 of the housing 501, and the lumen 509 of the cannula 505. Said another way, the openings 525 of the needle 520 are substantially unobstructed such that a flow of fluid substantially free from contaminates (e.g., dermally residing microbes) can be transferred to or from the patient via the openings 525 and the lumen 523 of the needle 520, the fluid flow path 508 of the housing 501, and the lumen 509 of the cannula 505, as indicated by the arrow GG in
While the needle 520 is shown in
Although not shown in
While the distal surface of the occlusion member 540 is shown and described as being aligned (e.g., coplanar) with the distal surface of the needle 520 when the occlusion member 540 is in the first configuration, in other embodiments, a transfer device can include an occlusion member that at least temporarily circumscribes substantially the entire needle. For example,
The housing 601 has a proximal end portion 602, the distal end portion 603, and a medial portion 604. As shown in
The occlusion mechanism 640 has a proximal end portion 642 and a distal end portion 643, and defines a lumen 644 therebetween. The proximal end portion 642 of the occlusion member 640 can be coupled to the medial portion 604 of the housing 601. The distal end portion 643 of the occlusion member 640 includes a set of fingers 645 that can selectively enclose the distal end portion 622 of the needle 620. As described in further detail herein, the distal end portion 643 defines a set of openings 646 that can be selectively aligned with the openings 625 of the needle 620. In this manner, the occlusion mechanism 640 is disposed about a portion of the needle 620 and can be movable between a first configuration (
As shown in
As shown in
Once the distal end portion 622 of the needle 620 is disposed within the vein, the occlusion member 640 can be moved from the second configuration to the third configuration, as indicated by the arrow II in
Although not shown in
While the transfer devices 200, 300, 400, 500, and 600 described above include an occlusion member (e.g., the occlusion members 241, 341, 440, 540, and 640), in other embodiments, a transfer device can include a needle or the like that can transform between a first, obstructed configuration and a second, unobstructed configuration. For example,
The needle 720 has the proximal end portion (not shown) and a distal end portion 722 and defines a lumen 723 therebetween. The proximal end portion (not shown) of the needle 720 is physically and fluidically coupled to the distal end portion 703 of the housing 701, as described above with reference to
In use, the transfer device 700 can be in the first configuration (
While the needle 720 is described above as being formed from a material that can be reconfigured, in other embodiments, the needle 720 can include a coating or the like that can be transformed from the first configuration to the second configuration. For example, in some embodiments, the needle 720 can be coated with a material that can dissolve when placed in contact with a fluid (e.g., when disposed in the vein of the patient).
Although not shown in
The method 890 includes disposing the occlusion mechanism in a first configuration in which the lumen of the needle is obstructed to prevent tissue or other undesirable external contaminants from entering the lumen, at 891. For example, in some embodiments, the occlusion mechanism can include an occlusion member that is disposed within a portion of the lumen of the needle such that at least a portion of the lumen is fluidically isolated from a portion distal to the occlusion member (e.g., as described above with reference to the transfer device 200 (
While in the first configuration, the needle is inserted into the patient, at 892. In this manner, the distal end portion of the needle can pierce the skin of the patient to dispose the distal end portion of the needle within, for example, a vein. In some instances, the venipuncture event (e.g., the insertion of the distal end portion of the needle into the vein) can dislodge, for example, dermally residing microbes from the insertion point. In other instances, external contaminants and microbes may be present on a patient's skin as noted in above. Thus, with the occlusion mechanism in the first configuration where the occlusion member obstructs the lumen of the needle, the lumen is isolated from the dislodged dermally residing microbes and/or other undesirable external contaminants.
After the needle has been inserted into the patient, the occlusion mechanism is moved to a second configuration in which the lumen of the needle is unobstructed to allow fluid transfer to or from the patient, at 893. For example, the occlusion member can be translated, rotated, transformed, 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 manually moved from the first configuration to the second configuration. In other embodiments, the occlusion member can automatically move or transform from the first configuration to the second configuration. In still other embodiments, the user can manipulate an actuator or the like that is operable in moving or transforming the occlusion member from the first configuration to the second configuration.
In some embodiments, the needle and/or any other suitable portion of the transfer device can be physically and fluidically coupled to a fluid reservoir (not shown). The fluid reservoir can be any suitable fluid reservoir such as, for example, known fluid reservoirs configured to collect and/or deliver a parenteral fluid. Thus, a fluid can be transferred between the patient and the fluid reservoir. In some instances, the embodiments and methods described herein can be used with a fluid transfer device such as, for example, those described in U.S. Pat. No. 8,535,241, filed Oct. 12, 2012, entitled “Fluid Diversion Mechanism for Bodily-Fluid Sampling” and U.S. Provisional Patent Application Ser. No. 61/712,468, filed Oct. 11, 2012, entitled “Systems and Methods for Delivering a Fluid to a Patient With Reduced Contamination,” the disclosures of which are incorporated herein by reference in their entireties. In such instances, by obstructing the lumen of the needle as shown and described by the embodiments and methods herein, the quantity (e.g., concentration and/or volumetric ratio) of contaminants such as, for example, dermally residing microbes, included in a diversion volume is reduced. Thus, the diversion volume that is drawn prior to drawing a sample volume can be reduced. Moreover, the sample volume drawn through the lumen of the needle after the diversion volume has been collected can be substantially free from contaminants and/or the like that, in some instances, can lead to false positive or false negative results when testing the sample volume.
While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Additionally, certain steps may be partially completed before proceeding to subsequent steps.
While various embodiments have been particularly shown and described, various changes in form and details may be made. For example, while the occlusion member 541 is shown and described with respect to
Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having any combination or sub-combination of any features and/or components from any of the embodiments described herein.
The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired rate of bodily fluid flow into a fluid reservoir or for a desired rate of parenteral fluid flow into the patient. Similarly, the size and/or specific shape of various components can be specifically selected for a desired fluid reservoir. For example, portions of the embodiments described herein can be modified such that any suitable container, microcontainer, microliter container, vial, microvial, microliter vial, nanovial, sample bottle, culture bottle, etc. can be placed in contact with a disinfection member to sterilize one or more interfaces associated therewith prior to a bodily-fluid being drawn into a volume so defined.
This application is a continuation of U.S. patent application Ser. No. 14/490,099, filed Sep. 18, 2014, entitled “Methods and Apparatus for Selectively Occluding the Lumen of a Needle,” now U.S. Pat. No. 9,788,774, which is a continuation of U.S. patent application Ser. No. 14/200,453, filed Mar. 7, 2014, entitled “Methods and Apparatus for Selectively Occluding the Lumen of a Needle,” which claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 61/777,758 entitled, “Lumenless Needle for Bodily Fluid Sample Collection,” filed Mar. 12, 2013, the disclosures of which are incorporated herein by reference in their entirety.
Number | Name | Date | Kind |
---|---|---|---|
2630803 | Baran | Mar 1953 | A |
2707953 | Ryan | May 1955 | A |
2847995 | Adams | Aug 1958 | A |
2850007 | Lingley | Sep 1958 | A |
2992974 | Belcove et al. | Jul 1961 | A |
3013557 | Pallotta | Dec 1961 | A |
3098016 | Cooper et al. | Jul 1963 | A |
3304934 | Bautista | Feb 1967 | A |
3382865 | Worral, Jr. | May 1968 | A |
3405706 | Cinqualbre | Oct 1968 | A |
3467095 | Ross | Sep 1969 | A |
3494351 | Horn | Feb 1970 | A |
3577980 | Cohen | May 1971 | A |
3635798 | Kirkham et al. | Jan 1972 | A |
3648684 | Barnwell et al. | Mar 1972 | A |
3777773 | Tolbert | Dec 1973 | A |
3848579 | Villa-Real | Nov 1974 | A |
3848581 | Cinqualbre et al. | Nov 1974 | A |
3890203 | Mehl | Jun 1975 | A |
3890968 | Pierce et al. | Jun 1975 | A |
3937211 | Merten | Feb 1976 | A |
3978846 | Bailey | Sep 1976 | A |
4056101 | Geissler et al. | Nov 1977 | A |
4057050 | Sarstedt | Nov 1977 | A |
4063460 | Svensson | Dec 1977 | A |
4106497 | Percarpio | Aug 1978 | A |
4133863 | Koenig | Jan 1979 | A |
4166450 | Abramson | Sep 1979 | A |
4340067 | Rattenborg | Jul 1982 | A |
4370987 | Bazell et al. | Feb 1983 | A |
4416291 | Kaufman | Nov 1983 | A |
4425235 | Cornell et al. | Jan 1984 | A |
4444203 | Engelman | Apr 1984 | A |
4459997 | Sarstedt | Jul 1984 | A |
4509534 | Tassin, Jr. | Apr 1985 | A |
4537593 | Alchas | Aug 1985 | A |
4654027 | Dragan et al. | Mar 1987 | A |
4657160 | Woods et al. | Apr 1987 | A |
4673386 | Gordon | Jun 1987 | A |
4737146 | Amaki et al. | Apr 1988 | A |
4790830 | Hamacher | Dec 1988 | A |
4808157 | Coombs | Feb 1989 | A |
4865583 | Tu | Sep 1989 | A |
4886072 | Percarpio et al. | Dec 1989 | A |
4890627 | Haber et al. | Jan 1990 | A |
4976697 | Walder | Dec 1990 | A |
4988339 | Vadher | Jan 1991 | A |
5009847 | Solomons | Apr 1991 | A |
5027827 | Cody et al. | Jul 1991 | A |
5064411 | Gordon, III | Nov 1991 | A |
5097842 | Bonn | Mar 1992 | A |
5100390 | Lubeck et al. | Mar 1992 | A |
5108927 | Dom | Apr 1992 | A |
5122129 | Olson et al. | Jun 1992 | A |
5234406 | Drasner et al. | Aug 1993 | A |
5269317 | Bennett | Dec 1993 | A |
5312345 | Cole | May 1994 | A |
5330464 | Mathias et al. | Jul 1994 | A |
5360011 | McCallister | Nov 1994 | A |
5423824 | Akerfeldt | Jun 1995 | A |
5429610 | Vaillancourt | Jul 1995 | A |
5431635 | Yoon | Jul 1995 | A |
5449351 | Zohmann | Sep 1995 | A |
5450856 | Norris | Sep 1995 | A |
5454786 | Harris | Oct 1995 | A |
5485854 | Hollister | Jan 1996 | A |
5507299 | Roland | Apr 1996 | A |
5511556 | DeSantis | Apr 1996 | A |
5573510 | Isaacson | Nov 1996 | A |
5578053 | Yoon | Nov 1996 | A |
5628734 | Hatfalvi | May 1997 | A |
5718678 | Fleming, III | Feb 1998 | A |
5807338 | Smith et al. | Sep 1998 | A |
5823970 | Terwilliger | Oct 1998 | A |
5848996 | Eldor | Dec 1998 | A |
5865812 | Correia | Feb 1999 | A |
5882318 | Boyde | Mar 1999 | A |
6016712 | Warden et al. | Jan 2000 | A |
6020196 | Hu et al. | Feb 2000 | A |
6024725 | Bollinger et al. | Feb 2000 | A |
6159164 | Neese et al. | Dec 2000 | A |
6210909 | Guirguis | Apr 2001 | B1 |
6328726 | Ishida et al. | Dec 2001 | B1 |
6364890 | Lum et al. | Apr 2002 | B1 |
6387086 | Mathias et al. | May 2002 | B2 |
6403381 | Mann et al. | Jun 2002 | B1 |
6478775 | Galt | Nov 2002 | B1 |
6520948 | Mathias et al. | Feb 2003 | B1 |
6554809 | Aves | Apr 2003 | B2 |
6626884 | Dillon et al. | Sep 2003 | B1 |
6692479 | Kraus et al. | Feb 2004 | B2 |
6716187 | Jorgensen et al. | Apr 2004 | B1 |
6746420 | Prestidge et al. | Jun 2004 | B1 |
6913580 | Stone | Jul 2005 | B2 |
7025751 | Silva et al. | Apr 2006 | B2 |
7044941 | Mathias et al. | May 2006 | B2 |
7060060 | Simpson et al. | Jun 2006 | B1 |
7087047 | Kraus et al. | Aug 2006 | B2 |
7204828 | Rosiello | Apr 2007 | B2 |
7211074 | Sansoucy | May 2007 | B2 |
7258694 | Choi et al. | Aug 2007 | B1 |
7335188 | Graf | Feb 2008 | B2 |
7384416 | Goudaliez et al. | Jun 2008 | B2 |
7744573 | Gordon et al. | Jun 2010 | B2 |
7993310 | Rosiello | Aug 2011 | B2 |
8197420 | Patton | Jun 2012 | B2 |
8231546 | Patton | Jul 2012 | B2 |
8292841 | Gregersen | Oct 2012 | B2 |
8337418 | Patton | Dec 2012 | B2 |
8535241 | Bullington et al. | Sep 2013 | B2 |
8647286 | Patton | Feb 2014 | B2 |
8864684 | Bullington et al. | Oct 2014 | B2 |
8876734 | Patton | Nov 2014 | B2 |
9022950 | Bullington et al. | May 2015 | B2 |
9022951 | Bullington et al. | May 2015 | B2 |
9060724 | Bullington et al. | Jun 2015 | B2 |
9060725 | Bullington et al. | Jun 2015 | B2 |
9149576 | Bullington et al. | Oct 2015 | B2 |
9204864 | Bullington et al. | Dec 2015 | B2 |
9283331 | Olson | Mar 2016 | B2 |
9788774 | Bullington | Oct 2017 | B2 |
9788775 | Bullington | Oct 2017 | B2 |
20020002349 | Flaherty et al. | Jan 2002 | A1 |
20020042581 | Cervi | Apr 2002 | A1 |
20020072720 | Hague et al. | Jun 2002 | A1 |
20020107469 | Bolan et al. | Aug 2002 | A1 |
20020183651 | Hyun | Dec 2002 | A1 |
20020193751 | Theeuwes et al. | Dec 2002 | A1 |
20030055381 | Wilkinson | Mar 2003 | A1 |
20030069543 | Carpenter et al. | Apr 2003 | A1 |
20030139752 | Pasricha et al. | Jul 2003 | A1 |
20030208151 | Kraus et al. | Nov 2003 | A1 |
20030225344 | Miller | Dec 2003 | A1 |
20040010228 | Swenson et al. | Jan 2004 | A1 |
20040054283 | Corey et al. | Mar 2004 | A1 |
20040054333 | Theeuwes et al. | Mar 2004 | A1 |
20040147855 | Marsden | Jul 2004 | A1 |
20040167427 | Quick et al. | Aug 2004 | A1 |
20050004524 | Newby et al. | Jan 2005 | A1 |
20050131344 | Godaire | Jun 2005 | A1 |
20050148993 | Mathias et al. | Jul 2005 | A1 |
20050199077 | Prybella et al. | Sep 2005 | A1 |
20050240161 | Crawford | Oct 2005 | A1 |
20050245885 | Brown | Nov 2005 | A1 |
20050273019 | Conway et al. | Dec 2005 | A1 |
20050281713 | Hampsch et al. | Dec 2005 | A1 |
20060251622 | Suzuki et al. | Nov 2006 | A1 |
20060287639 | Sharp | Dec 2006 | A1 |
20070100250 | Kline | May 2007 | A1 |
20070232956 | Harman et al. | Oct 2007 | A1 |
20080108954 | Mathias et al. | May 2008 | A1 |
20080145933 | Patton | Jun 2008 | A1 |
20090306601 | Shaw et al. | Dec 2009 | A1 |
20100042048 | Christensen | Feb 2010 | A1 |
20100152681 | Mathias | Jun 2010 | A1 |
20100234760 | Almazan | Sep 2010 | A1 |
20110306899 | Brown et al. | Dec 2011 | A1 |
20120035540 | Ferren et al. | Feb 2012 | A1 |
20120083740 | Chebator et al. | Apr 2012 | A1 |
20120136337 | Olson | May 2012 | A1 |
20120323180 | Chebator et al. | Dec 2012 | A1 |
20140155782 | Bullington et al. | Jun 2014 | A1 |
20140276578 | Bullington et al. | Sep 2014 | A1 |
20150018715 | Walterspiel | Jan 2015 | A1 |
20150073348 | Bullington et al. | Mar 2015 | A1 |
20150094615 | Patton | Apr 2015 | A1 |
20160287792 | Olson et al. | Oct 2016 | A1 |
20160287793 | Olson et al. | Oct 2016 | A1 |
20160287795 | Olson et al. | Oct 2016 | A1 |
20160287796 | Olson et al. | Oct 2016 | A1 |
20160287797 | Olson et al. | Oct 2016 | A1 |
20170157336 | Olson et al. | Jun 2017 | A1 |
20190076074 | Bullington et al. | Mar 2019 | A1 |
Number | Date | Country |
---|---|---|
22 05 314 | Aug 1973 | DE |
0761173 | Mar 1997 | EP |
0608985 | Apr 1997 | EP |
0727187 | Aug 2003 | EP |
07-016219 | Jan 1995 | JP |
2006-43392 | Feb 2006 | JP |
WO 9500189 | Jan 1995 | WO |
WO 1995016395 | Jun 1995 | WO |
WO 2000024313 | May 2000 | WO |
WO 2005068011 | Jul 2005 | WO |
WO 2008077047 | Jun 2008 | WO |
WO 2013181352 | Dec 2013 | WO |
WO 2014058945 | Apr 2014 | WO |
WO 2014085800 | Jun 2014 | WO |
WO 2014089186 | Jun 2014 | WO |
WO 2014099266 | Jun 2014 | WO |
WO 2014164263 | Oct 2014 | WO |
WO 2016161062 | Oct 2016 | WO |
Entry |
---|
Office Action for U.S. Appl. No. 11/955,635, dated Jul. 22, 2010, 11 pages. |
Office Action for U.S. Appl. No. 11/955,635, dated Dec. 3, 2010, 11 pages. |
Office Action for U.S. Appl. No. 13/335,241, dated Apr. 20, 2012, 12 pages. |
Office Action for U.S. Appl. No. 13/458,508, dated Jul. 24, 2012, 13 pages. |
Office Action for U.S. Appl. No. 13/675,295, dated May 23, 2013, 15 pages. |
Office Action for U.S. Appl. No. 14/089,267, dated Jun. 19, 2014, 13 pages. |
Office Action for U.S. Appl. No. 14/498,102, dated Oct. 17, 2017, 21 pages. |
Office Action for U.S. Appl. No. 13/954,528, dated Mar. 17, 2014, 10 pages. |
Office Action for U.S. Appl. No. 14/493,796, dated Jan. 27, 2015, 7 pages. |
Office Action for U.S. Appl. No. 14/494,208, dated Jan. 27, 2015, 7 pages. |
Office Action for U.S. Appl. No. 14/200,453, dated Feb. 29, 2016, 16 pages. |
Office Action for U.S. Appl. No. 14/200,453, dated Nov. 8, 2016, 21 pages. |
Office Action for U.S. Appl. No. 14/490,099, dated Jun. 26, 2015, 11 pages. |
Office Action for U.S. Appl. No. 14/490,099, dated Dec. 16, 2015, 10 pages. |
Office Action for U.S. Appl. No. 14/490,099, dated Sep. 8, 2016, 10 pages. |
Office Action for U.S. Appl. No. 14/496,296, dated Jun. 25, 2015, 34 pages. |
Office Action for U.S. Appl. No. 14/496,296, dated Jan. 15, 2016, 28 pages. |
Office Action for U.S. Appl. No. 14/496,296, dated Sep. 30, 2016, 19 pages. |
Office Action for U.S. Appl. No. 14/049,326, dated Apr. 24, 2015, 10 pages. |
Office Action for U.S. Appl. No. 14/838,794, dated Aug. 3, 2017, 7 pages. |
Office Action for U.S. Appl. No. 13/952,964, dated Mar. 20, 2015, 11 pages. |
International Search Report and Written Opinion for International Application No. PCT/US2007/087951 dated May 16, 2008, 8 pages. |
International Search Report and Written Opinion for International Application No. PCT/US2013/071491, dated Aug. 5, 2014, 9 pages. |
International Search Report and Written Opinion for International Application No. PCT/US2013/043289, dated Oct. 24, 2013, 15 pages. |
International Search Report and Written Opinion for International Application No. PCT/US2013/073080, dated Feb. 18, 2014, 14 pages. |
International Search Report and Written Opinion for International Application No. PCT/US2014/021564, dated Jun. 25, 2014, 14 pages. |
International Search Report and Written Opinion for International Application No. PCT/US2013/063975, dated Mar. 20, 2014, 16 pages. |
International Search Report and Written Opinion for International Application No. PCT/US2013/052493, dated Nov. 27, 2013, 7 pages. |
Arkin, C. F. et al., “Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard,” Fifth Edition, Clinical and Laboratory Standards Institute, vol. 23, No. 32 (2003), 52 pages. |
Calam, R. R., “Recommended ‘Order of Draw’ for Collecting Blood Specimens Into Additive-Containing Tubes,” Letter to the Editor, Clinical Chemistry, 28(6):1399 (1982). |
Hall, K. K. et al., “Updated Review of Blood Culture Contamination,” Clinical Microbiology Reviews, 19(4):788-802 (2006). |
Kim, J. Y. et al., “The Sum of the Parts is Greater Than the Whole: Reducing Blood Culture Contamination,” Annals of Internal Medicine, 154:202-203 (2011). |
Levin, P. D. et al., “Use of the Nonwire Central Line Hub to Reduce Blood Culture Contamination,” Chest, 143(3):640-645 (2013). |
Medical Surgical Systems Catalogue (Canadian Version), BD Medical, 2010, 51 pages. |
Notice of Reasons for Rejection for Japanese Application No. 2016-500787, dated Jan. 9, 2018, 11 pages. |
Order of Draw for Multiple Tube Collections, LabNotes, a newsletter from BD Diagnostics,—Preanalytical Systems, 17(1):3 (2007). |
Patton, R. G. et al., “Innovation for Reducing Blood Culture Contamination: Initial Specimen Diversion Technique,” Journal of Clinical Microbiology, 48(12):4501-4503 (2010). |
Proehl, J. A. et al., “Clinical Practice Guideline: Prevention of Blood Culture Contamination, Full Version,” 2012 ENA Emergency Nurses Resources Development Committee, Emergency Nurses Association (Dec. 2012), 14 pages. |
Schuur, J., “Blood Cultures: When Do they Help and When Do They Harm?” Brigham & Women's Hospital, Department of Emergency Medicine, (Jun. 21-23, 2012), 42 pages. |
Sibley, C. D. et al., “Molecular Methods for Pathogen and Microbial Community Detection and Characterization: Current and Potential Application in Diagnostic Microbiology,” Infection, Genetics and Evolution 12:505-521 (2012). |
Stohl, S. et al., “Blood Cultures at Central Line Insertion in the Intensive Care Unit: Comparison with Peripheral Venipuncture,” Journal of Clinical Microbiology, 49(7):2398-2403 (2011). |
Wagner et al., “Diversion of Initial Blood Flow to Prevent Whole-Blood Contamination by Skin Surface Bacteria: an in vitro model,” Transfusion, 40:335-338 (2000). |
Wang, P. et al., “Strategies on Reducing Blood Culture Contamination,” Reviews in Medical Microbiology, 23:63-66 (2012). |
Office Action for U.S. Appl. No. 14/498,102, dated Sep. 24, 2018, 18 pages. |
Office Action for U.S. Appl. No. 15/829,015, dated Feb. 6, 2018, 24 pages. |
Office Action for U.S. Appl. No. 15/829,018, dated Feb. 16, 2018, 24 pages. |
Office Action for U.S. Appl. No. 15/829,023, dated Feb. 7, 2018, 25 pages. |
Office Action for U.S. Appl. No. 15/832,055, dated Feb. 8, 2018, 21 pages. |
Office Action for U.S. Appl. No. 15/832,087, dated Feb. 7, 2018, 24 pages. |
Office Action for U.S. Appl. No. 15/832,091, dated Feb. 22, 2018, 16 pages. |
Office Action for U.S. Appl. No. 14/662,676, dated Sep. 5, 2018, 25 pages. |
Office Action for U.S. Appl. No. 14/712,437 dated Oct. 25, 2018, 20 pages. |
Office Action for U.S. Appl. No. 15/854,273, dated Sep. 7, 2018, 15 pages. |
Office Action for U.S. Appl. No. 14/096,826, dated Mar. 8, 2018, 16 pages. |
Office Action for U.S. Appl. No. 14/728,318, dated Jan. 8, 2018, 36 pages. |
Office Action for U.S. Appl. No. 14/926,784, dated May 25, 2018, 18 pages. |
Examination Report for United Kingdom Application No. GB1805101.1, dated May 25, 2018, 8 pages. |
Extended European Search Report for European Application No. 17204012.3, dated Feb. 14, 2018, 7 pages. |
Notice of Reasons for Rejection for Japanese Application No. 2016-500787, dated Jul. 17, 2018, 4 pages. |
Extended European Search Report for European Application No. 17206745.6, dated Feb. 19, 2018. |
Extended European Search Report for Application No. 18194131.1, dated Jan. 29, 2019, 7 pages. |
Office Action for Canadian Application No. 2,875,118, dated Mar. 21, 2019, 5 pages. |
Number | Date | Country | |
---|---|---|---|
20180125403 A1 | May 2018 | US |
Number | Date | Country | |
---|---|---|---|
61777758 | Mar 2013 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 14490099 | Sep 2014 | US |
Child | 15705695 | US | |
Parent | 14200453 | Mar 2014 | US |
Child | 14490099 | US |