WO2020060708A2 - Interconnecting blood collection tubes - Google Patents

Interconnecting blood collection tubes Download PDF

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Publication number
WO2020060708A2
WO2020060708A2 PCT/US2019/047174 US2019047174W WO2020060708A2 WO 2020060708 A2 WO2020060708 A2 WO 2020060708A2 US 2019047174 W US2019047174 W US 2019047174W WO 2020060708 A2 WO2020060708 A2 WO 2020060708A2
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WIPO (PCT)
Prior art keywords
blood collection
collection tubes
test tube
tube
tubes
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Application number
PCT/US2019/047174
Other languages
French (fr)
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WO2020060708A3 (en
Inventor
Mark Philip WHITE
Original Assignee
White Mark Philip
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Publication of WO2020060708A2 publication Critical patent/WO2020060708A2/en
Publication of WO2020060708A3 publication Critical patent/WO2020060708A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/15074Needle sets comprising wings, e.g. butterfly type, for ease of handling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150755Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150763Details with identification means
    • A61B5/150786Optical identification systems, e.g. bar codes, colour codes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082Test tubes per se
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082Test tubes per se
    • B01L3/50825Closing or opening means, corks, bungs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00Supporting devices; Holding devices
    • B01L9/50Clamping means, tongs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150305Packages specially adapted for piercing devices or blood sampling devices
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02Adapting objects or devices to another
    • B01L2200/025Align devices or objects to ensure defined positions relative to each other
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02Adapting objects or devices to another
    • B01L2200/026Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16Reagents, handling or storing thereof
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/042Caps; Plugs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/044Connecting closures to device or container pierceable, e.g. films, membranes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0475Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0487Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure fluid pressure, pneumatics
    • B01L2400/049Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure fluid pressure, pneumatics vacuum

Definitions

  • the present disclosure relates generally to blood collection tubes, and more particularly to blood collection tubes that may be releasably interconnected with one another.
  • Vacutainer is a trademark of Becton Dickinson; however, the term “vacutainer” has become so ubiquitous as to be understood as a generic term as well. The first patent was issued in 1949, and it was originally called the
  • Evacutainer It is derived from the contraction of 'vacuum' or 'evacuated' and 'container,' describing a system for drawing blood that consists of the following three components:
  • the blood tube consists of four components:
  • a hollow chamber commonly described as a test tube (tube).
  • a plastic cap (cap). This cap was patented in 1990 as a safety feature.
  • the tubes can be made of any transparent rigid material, glass or plastic. They are generally a standard diameter, 12.3mm, but they can be of varying lengths that determine their capacity.
  • the reagent determines the diagnostic tests that can be performed on a blood sample.
  • the stopper is made of a self-sealing material, such as rubber, that can be easily punctured with a hollow needle. The stopper ensures that a vacuum can be maintained within the tube, which allows blood to be easily extracted from the patient. The stopper also ensures that blood will stay within the tube until it is extracted for a diagnostic test.
  • the plastic cap performs the following three functions:
  • the two-sided needle is, in practice, an arrangement of two needles connected by a conduit. It provides a mechanism for puncturing both the patient and the tube, and a conduit allowing blood to flow from patient to tube.
  • This conduit can be of varying lengths and materials, and can itself consist of multiple conduits and connections.
  • the simplest arrangement consists of a steel tube sharpened at both ends.
  • Another common arrangement is known as a butterfly needle, which consists of two needles connected by clear, flexible tubing. This is called a butterfly because it typically has two plastic tabs used for holding the patient-side needle, and they resemble a butterfly.
  • the tube-side needle has a threaded hub, commonly referred to as a Luer lock, that allows it to be secured to a separate holding mechanism.
  • the needle holder can be any one of many possible mechanisms.
  • the simplest arrangement consists of a barrel that holds a Luer lock at one end, and an opening large enough to admit a single tube at the other end.
  • the QuickDraw device is a more complex needle holder that mechanizes an ability to sequentially puncture one or more tubes. A mechanism for sequential puncturing tubes was patented in 1970.
  • Tubes are separate, and therefore must be managed separately.
  • a patient may require a single test, and so a single tube is required. Or, two tests that require different tubes may be needed. If there are merely six different tube options - and there are many more than six real-world options - there would be thirty-six possible two-tube combinations.
  • the combinatorics cause the number of scenarios to grow rapidly. Often tubes must be drawn in a certain order because of reagent interactions. The actual number of scenarios quickly becomes unmanageable.
  • tubes would be manufactured and or prepared in advance in the most efficient combination. Unfortunately, it is often not possible to know - even at the time blood is drawn - which tubes will be needed. This is so common, in fact, that there is a solution used in the field that is called a rainbow. For a rainbow of tubes to be drawn means that five tubes, red - blue - green - purple - gray, are drawn, often in that sequence.
  • tubes are filled with blood, from a practical standpoint, they must somehow be kept together to the point that they are received in the lab and ready to be analyzed. In the field this is commonly achieved with a plastic bag, a rubber band, or adhesive tape. This merely adds additional components, extra steps, and multiple opportunities for inefficiencies and errors. Tubes often get misplaced or lost.
  • an interconnecting blood collection tube includes a test tube with an inner surface that partially defines a hollow chamber, which has a reagent positioned therein.
  • a stopper closes an open end of the test tube and defines a portion of the hollow chamber.
  • a cap secures the stopper to the test tube.
  • a pressure in the hollow chamber is less than a pressure on an outer surface of the test tube.
  • One of the test tube, the cap or an added piece mounted on the test tube includes an outward facing first mateable connection surface at a first location about a longitudinal axis of the test tube, and a outward facing second mateable connection surface at a second location, which is different from the first location, about the longitudinal axis.
  • Each of the first and second mateable connection surfaces are configured to matingly connect to a respective one of a second mateable connection surface and a first mateable connection surface of another interconnecting blood collection tube in a side by side axially parallel orientation.
  • an interconnecting set of blood collection tubes includes a first blood collection and a second blood collection tube.
  • the first and second blood collection tubes have a connected configuration in which the blood collection tubes are in contact in a side-by-side parallel orientation, and a disconnected configuration, in which the blood collection tubes are out of contact with each other.
  • the first mateable connection surface of the first collection tube is matingly connected to the second mateable connection surface of the second blood collection tube in the connected configuration.
  • a method of using a set of interconnecting blood collection tubes includes moving the blood collection tubes from a disconnected configuration to a connected configuration. While in a connected configuration, the stopper of the first blood collection tube is punctured with a hollow needle. Thereafter, the hollow needle is moved out of contact with the stopper of the first blood collection tube and punctures the stopper of a second blood collection tube. Thereafter, the hollow needle may be moved out of contact with the stopper of the second blood collection tube and sequentially puncture the stopper of third, fourth or more blood collection tubes before being moved out of contact with all of the blood collection tubes. This process may be done by hand, or may be at least partially mechanized.
  • Fig. l is a front side view of an interconnecting blood collection tube according to the present disclosure.
  • FIG. 2 includes several views of a cap for an interconnecting blood collection tube according to one aspect of the present disclosure
  • FIG. 3 is a perspective view of an interconnecting set of blood collection tubes in a disconnected configuration
  • FIG. 4 is a perspective view of the interconnecting set of blood collection tubes from Fig. 3 in a connected configuration
  • FIG. 5 is a top view of the interconnecting set of blood collection tubes of Fig. 4;
  • Fig. 6 is a front side view of the interconnecting set of blood collection tubes from Figs. 4 and 5;
  • FIG. 7 is a perspective view of an interconnecting set of blood collection tubes in a connected configuration positioned adjacent a puncturing machine according to another aspect of the present disclosure
  • Fig. 8 is a perspective view of the set of blood collection tubes from Fig. 7 mounted in the puncturing machine according to another aspect of the present disclosure
  • FIG. 9 is a partial perspective view of a pair of interconnecting blood collection tubes in a disconnected configuration showing detents according to another aspect of the present disclosure
  • Fig. 10 is a top view of the blood collection tubes from Fig. 9;
  • FIG. 11 is a top view of the interconnecting blood collection tubes of Figs. 9 and 10 in a connected configuration with a third blood collection tube;
  • Fig. 12 is a perspective view of the set of blood collection tubes from Fig. 11 in an initial step for using an interconnected set of blood collection tubes according to another aspect of the present disclosure
  • Fig. 13 is a side view of the interconnecting set of blood collection tubes from Fig. 12 after a first one of the blood collection tubes has been punctured by a hollow needle;
  • Fig. 14 is a perspective view and the method with the hollow needle preparing to puncture the stopper of a second one of the blood collection tubes;
  • Fig. 15 is a perspective view after the hollow needle has punctured the second one of the blood collection tubes according to a method of the present disclosure
  • FIG. 16 is a perspective view showing the hollow needle being moved for puncturing a third one of the blood collection tubes
  • Fig. 17 is a perspective view showing the hollow needle after puncturing the stopper of the third one of the blood collection tubes;
  • Fig. 18 is a perspective schematic view of a puncturing machine interacting with a first one from a set of blood collection tubes according to another aspect of the present disclosure;
  • FIG. 19 is a top and perspective view of a blood collection tube according to another aspect of the present disclosure in which the mateable surfaces are included on an extra component mounted about the test tube;
  • Fig. 20 includes top and perspective views of a blood collection tube according to another aspect of the present disclosure in which the mateable surfaces are integrally formed as a portion of the test tube;
  • Fig. 21 includes side and perspective views of a blood collection tube according to still another aspect of the present disclosure in which the tubes move to a mated configuration along a line perpendicular to a longitudinal axis of the test tube;
  • Fig. 22 includes top and perspective views of a blood collection tube according to another aspect of the present disclosure in which the blood collection tubes mate via a press fit;
  • Fig. 23 includes top and perspective views of a blood collection tube with flat mateable connection surfaces
  • Fig. 24 includes top and perspective views of a blood collection tube according to still another aspect of the present disclosure in which the mateable surfaces are round and maybe magnetic;
  • Fig. 25 includes top and perspective views of a blood collection tube according to another aspect of the present disclosure in which the mateable surfaces are distributed completely around the circumference of the cap;
  • Fig. 26 includes top and perspective views of a blood collection tube showing a configuration in which the tubes can be connected via either a press fit or via relative sliding according to another aspect of the present disclosure; and [0043] Fig. 27 includes side and perspective views of a blood collection tube according to another press fit connection strategy according to the present disclosure.
  • sample tubes be made so that they interconnect in some way, and can be connected and unconnected quickly and easily.
  • interconnected tubes can be sequentially accessed via a specialized needle holder designed for interconnected tubes.
  • Our proposal is to marry these two functions such that the interconnectivity also facilitates the sequential access.
  • interconnectivity is a solution that does not necessarily cause a new problem - it provides an opportunity for more solutions.
  • Adhesives or fasteners e.g. hook and loop
  • interconnecting tubes could be used in all the same ways that current tubes are used, so that no new components are required by the system.
  • tube pieces could contain a hook and loop system, or double-stick tape, or magnetic material could be embedded in the components.
  • each tube has a male adaptor on one side, and a female adapter on the other.
  • This allows for one or more tubes to be connected linearly. It is analogous to a Lego building block system. Tubes can be quickly and easily connected and unconnected. [0049] Once the tubes are linearly connected in this fashion, they provide surfaces that are utilized in sequential puncturing by specialized needle holder mechanisms. There are many possible mechanisms for this purpose. Common needle holders cannot accept connected tubes unless they are unconnected; however, connected tubes present new substrates that can be more easily utilized by mechanized needle holders.
  • QuickDraw utilizes a toothed drive belt that matches drive surface teeth in the tube cap. It utilizes position switches that detect a locating surface, such as a ridge, on the tube cap. It also utilizes a retaining bar that secures the tube to the mechanism via special cuts in the tube cap. This design merely replaces existing tube caps with new ones that interconnect, and mate with mechanized needle holders.
  • This particular device demonstrates this functionality by adding the following features to existing tube caps:
  • an interconnecting blood collection tube 10 includes a test tube 20 with an inner surface 21 that partially defines a hollow chamber 22.
  • a reagent 30 is positioned in the hollow chamber.
  • the reagent may be any of a number of substances known in the art including anti -coagulants, sodium, heparin, potassium oxalate and others.
  • a stopper 33 closes an open end 24 of the test tube 20 and defines a portion of the hollow chamber 22.
  • a cap 40 secures the stopper 33 to the test tube 20.
  • a test tube 20 according to the present disclosure includes a rounded closed end 25 opposite the open end 24, and a uniform diameter segment between the ends.
  • a pressure in the hollow chamber 22 is less than a pressure on an outer surface 23 of the test tube.
  • Blood collection tube 10 includes an outward facing first mateable connection surface 50 at a first location 51 about a longitudinal axis 26 of test tube 20, and an outward facing second mateable connection surface 52 at a second location 53, which is different than the first location, about the longitudinal axis 26.
  • the cap 40 includes the first and second mateable connection surfaces 50 and 52, and the respective first location 51 and second location 53 are opposite each other on opposite sides of cap 40.
  • the mateable connection surface features could be formed separately and attached to cap 40, the mateable connection surfaces are preferably integrally formed portions of the cap, which may be made from a suitable plastic material known in the art. Integrally formed means that the respective cap and connection surfaces were molded simultaneously and never had a separate identity apart from one another.
  • first and second mateable connection surfaces 50, 52 include a slide surface 55 oriented parallel to the longitudinal axis 26 so the blood collection tube 10 can be mateably connected to a second blood collection tube 10 by moving the slide surfaces 55 along one another along the longitudinal axis 26.
  • the second mateable connection surface 52 is not open on both ends so that it inherently includes a stop surface that contacts the first mateable connection surface 50 of a second blood collection tube when the two tubes are fully connected.
  • first and second mateable connection surfaces 50, 52 are configured to matingly connect to a respective one of a second mateable connection surface 52 and a first mateable connection surface 50 of another interconnecting blood collection tube in a side-by-side axially parallel orientation.
  • the first mateable connection surface 50 in this embodiment is male 60
  • the second mateable connection surface is female 61 and is sized and shaped to matingly match the male 60.
  • cap 40 may also be integrally formed to include at least one link 57 of a translational drive surface 65 that defines a drive direction 66 that is perpendicular to the longitudinal axis 26.
  • the blood collection tube 10 may include a machine readable unique identifier 27, such as a bar code 28, attached to one of the test tube 20 and the cap 40.
  • five interconnecting blood collection tubes 10 may be considered a set 70 of blood collection tubes that are shown in a disconnected configuration 72 in Fig. 3 and a connected configuration 71 in Figs. 4-6.
  • the caps of the various blood collection tubes 10 may be of different colors known in the art to indicate to the user what test might be performed on any blood contained within the tube and what reagent may be present.
  • the blood collection tubes may be of different lengths known in the art without departing from the present disclosure.
  • each of the blood collection tubes 10 may have identically shaped caps, which may be of different colors, and may include identically shaped test tubes 20, which may be of different lengths.
  • the caps 40 of the blood collection tubes are in contact with the respective connected blood collection tubes in a side-by-side parallel orientation.
  • the respective test tubes 20 remain out of contact with each other in the connected configuration 71.
  • the blood collection tubes are entirely out of contact with each other in the disconnected configuration 72 as shown in Fig. 3.
  • the set 70 of blood collection tubes 10, in the connected configuration 71 define a straight line 73 that intersects the respective longitudinal axis 26 of each of the blood collection tubes 10.
  • a curved or arc line passing through the respective longitudinal axis may be desirable without departing from the present disclosure.
  • such an arc may have a radius much larger than the radius of the respective test tubes, such as maybe one foot in such an alternative connective configuration.
  • the mateable connection surfaces 50, 52 may be arranged on the annular side surface 42 of the caps 40 so that a rainbow group of mated five blood collection tubes 10 may interconnect into a circle similar to a quick load configuration for a revolver firearm.
  • the top surfaces 41 of the respective caps 40 of the blood collection tubes 10 are flush in the connected configuration 71 as best shown in Fig. 6.
  • the blood collection tubes 10 together define a plurality of links 57 of a translational drive surface 65 that defines a drive direction 66 that is perpendicular to the longitudinal axis 26 in the event that the set 70 may need to interact with a mechanized device, such as the puncturing machine described infra.
  • a variation on the slide connect mateable connection surfaces includes a detent 56 rather than a stop surface as in the embodiment shown in Figs. 1-6.
  • this embodiment differs from the earlier embodiment in that the female mateable connection surface 52 opens on opposite ends, but relies upon an interaction of detents 56 to mark the full connection of the blood collection tubes 10 so that their top surfaces are flush when the detents 56 are in contact with one another. Nevertheless, slidable mateable connection surfaces without stop surfaces or detents could also fall within the intended scope of the present disclosure.
  • Figures 19-27 a variety of different shapes and strategies for interconnecting blood collection tubes 10 are illustrated. Fig.
  • FIG. 19 is of interest for showing blood collection tube 10 including a separate component 67 that may be mounted on test tube 20.
  • Component 67 may include the first and second mateable connection surfaces 50, 52.
  • the embodiment of Fig. 19 differs from currently available blood collection tubes 10 only by the inclusion of the extra mating component 67, which may be formed of a plastic similar to that of the cap 40, or be molded from another suitable material known in the art.
  • Fig. 20 is of interest for showing the mateable connection surfaces 50, 52 integrally formed as portions of the test tube 20 of blood collection tube 10.
  • Fig. 21 is of interest for showing a slide mateable connection surface
  • Fig. 22 is of interest for showing a configuration that permits a press fit connection in which the first and second mateable connection surfaces 50, 52 slightly deform while being pressed together, before maybe resiliently assuming their original shape that causes the two blood collection tubes 10 to remain connected.
  • Fig. 23 is of interest for showing mateable first and second connection surfaces 50, 52 that may lay in a plane to facilitate use of adhesives, hook and loop fasteners or maybe even magnets, as shown, to facilitate connection between two or more blood collection tubes 10.
  • first and second mateable connection surfaces 50, 52 may both be convex in shape and still be interconnecting, such as by incorporating magnetic features into cap 40, and/or adhesives or maybe even hook and loop fasteners.
  • Fig. 25 is of interest for showing another press fit configuration for first and second mateable connection surfaces 50, 52, which are shown distributed completely around the annular side surface 42 of cap 40 so that blood collection tubes may be joined together in a clustered bunch rather than along a line as shown in the embodiment of Figs. 1-6.
  • Fig. 27 shows still another configuration in which the first and second mateable connection surfaces 50 and 52 are distributed completely around cap 40 and may permit blood collection tubes to be connected in a configuration other than a side-by-side parallel orientation as discussed previously, with the connection being facilitated via a press fit.
  • the present disclosure finds general applicability in blood collection tubes.
  • the present disclosure find particular applicability in associating a plurality of blood collection tubes for one patient at the time of blood collection.
  • the present disclosure might also enable some automation or mechanization in the blood collection process, and may further facilitate processing and testing after blood collection.
  • a set 70 of blood collection tubes in a connected configuration 71 may be used with a machine, such as puncturing machine 90 to automate and hasten a blood collection procedure.
  • Puncturing machine 90 may include a needle holder 94 that is shown with a hollow needle 80 mounted therein which is connected to a conventional butterfly needle 95, that may be connected with a patient's vein in a conventional manner.
  • Puncturing machine 90 may include a needle reciprocator 93 that moves hollow needle 80 into and out of contact with the respective stopper of one blood collection tube 10 in the set 70 while a drive mechanism 91 may move the set 70 via interaction with a translational drive surface 65 (Figs.
  • puncturing machine 90 might also include a code scanner 92 to read a unique machine readable code attached to each blood collection tube 10, and maybe associate all of the unique identifiers in the set 70 with an individual patient to further avoid errors. Puncturing machine 90 might also detect a locating surface 54 (Fig. 2) to stop the set 70 for each puncturing step.
  • Figs. 12-17 a by-hand method of using a set of interconnecting blood collection tubes 10 is illustrated.
  • the blood collection tubes 10 are moved from a disconnected configuration 72 as shown in Fig. 3 to a connected configuration 71 as shown in Fig. 12.
  • the user may then hold an outer slotted guard portion 81 of a blood draw set that conceals a hollow needle 80 with one hand, while holding the set 70 of blood collection tubes in their opposite hand.
  • the hollow needle 80 is aligned with a first one of the blood collection tubes 10 and then the hollow needle is moved as shown in Fig. 13 to puncture the stopper of the first blood collection tube 10 to allow blood to flow therein.
  • the hollow needle 80 is moved out of contact with the first blood collection tube and aligned with the second blood collection tube 10 as shown in Fig. 14.
  • the hollow needle 80 is moved to puncture the stopper of the second blood collection tube 10 as shown in Fig. 15 to collect blood in the second blood collection tube 10.
  • the hollow needle 80 is moved out of the second blood collection tube 10 and aligned with the third blood collection tube 10 as shown in Fig. 16.
  • the hollow needle 80 is moved to puncture the stopper of the third blood collection tube 10 to allow blood to be collected in the third blood collection tube.
  • the hollow needle 80 is moved out of contact with the set 70 of blood collection tubes with the blood collection procedure being completed.
  • the blood collection tubes 10 augments the standard practice of using the vacutainer system of drawing blood. It serves two primary functions within that system:

Abstract

Interconnecting blood collection tubes are typical in that each one includes a test tube containing a reagent and a rubber stopper, which is secured to the test tube by a cap, to close an open end of the test tube. A pressure in the hollow chamber defined by the test tube and stopper is less than a pressure on an outer surface of the test tube. One of the test tube, the cap or maybe an additional component includes outwardly facing first and second mateable connection surfaces that permit a plurality of like shaped interconnecting blood collection tubes to be connected to one another in a side-by-side axially parallel orientation.

Description

INTERCONNECTING BLOOD COLLECTION TUBES
Technical Field
[0001] The present disclosure relates generally to blood collection tubes, and more particularly to blood collection tubes that may be releasably interconnected with one another.
Background
[0002] Vacutainer is a trademark of Becton Dickinson; however, the term "vacutainer" has become so ubiquitous as to be understood as a generic term as well. The first patent was issued in 1949, and it was originally called the
Evacutainer. It is derived from the contraction of 'vacuum' or 'evacuated' and 'container,' describing a system for drawing blood that consists of the following three components:
1. An evacuated blood tube, or a tube containing vacuum.
2. A two-sided needle.
3. A needle holder
The blood tube consists of four components:
1. A hollow chamber commonly described as a test tube (tube).
2. A reagent within the tube (reagent).
3. A rubber stopper (stopper).
4. A plastic cap (cap). This cap was patented in 1990 as a safety feature.
[0003] The tubes can be made of any transparent rigid material, glass or plastic. They are generally a standard diameter, 12.3mm, but they can be of varying lengths that determine their capacity. The reagent determines the diagnostic tests that can be performed on a blood sample. The stopper is made of a self-sealing material, such as rubber, that can be easily punctured with a hollow needle. The stopper ensures that a vacuum can be maintained within the tube, which allows blood to be easily extracted from the patient. The stopper also ensures that blood will stay within the tube until it is extracted for a diagnostic test. The plastic cap performs the following three functions:
1. It helps secure the stopper to the tube.
2. It provides a splash guard when the stopper is removed from a blood-filled tube.
3. It provides a color code signifying the reagent within the tube.
[0004] The two-sided needle is, in practice, an arrangement of two needles connected by a conduit. It provides a mechanism for puncturing both the patient and the tube, and a conduit allowing blood to flow from patient to tube. This conduit can be of varying lengths and materials, and can itself consist of multiple conduits and connections. The simplest arrangement consists of a steel tube sharpened at both ends. Another common arrangement is known as a butterfly needle, which consists of two needles connected by clear, flexible tubing. This is called a butterfly because it typically has two plastic tabs used for holding the patient-side needle, and they resemble a butterfly. The tube-side needle has a threaded hub, commonly referred to as a Luer lock, that allows it to be secured to a separate holding mechanism.
[0005] The needle holder can be any one of many possible mechanisms. The simplest arrangement consists of a barrel that holds a Luer lock at one end, and an opening large enough to admit a single tube at the other end. The QuickDraw device is a more complex needle holder that mechanizes an ability to sequentially puncture one or more tubes. A mechanism for sequential puncturing tubes was patented in 1970.
[0006] This disclosure addresses two basic problems within the general vacutainer system as it exists today:
1. Tubes are separate, and therefore must be managed separately.
2. Sample acquisition requires time, skill, and dexterity. [0007] It is unknown in advance for each patient which tests will be required; therefore, it is unknown which reagents and what quantity of blood to use. In practice, this leads to a separation of tubes from manufacture, to the process of sample acquisition, all the way through the point of delivery to laboratory testing. This causes many logistics problems and many inefficiencies and errors.
[0008] For instance, a patient may require a single test, and so a single tube is required. Or, two tests that require different tubes may be needed. If there are merely six different tube options - and there are many more than six real-world options - there would be thirty-six possible two-tube combinations. The combinatorics cause the number of scenarios to grow rapidly. Often tubes must be drawn in a certain order because of reagent interactions. The actual number of scenarios quickly becomes unmanageable.
[0009] The simple standard solution to this problem has been to keep the tubes separate and tailor the tube sequence at the point of acquisition. Although this solution works for the intended purpose, it introduces many inefficiencies and opportunities for error.
[0010] In an ideal world, tubes would be manufactured and or prepared in advance in the most efficient combination. Unfortunately, it is often not possible to know - even at the time blood is drawn - which tubes will be needed. This is so common, in fact, that there is a solution used in the field that is called a rainbow. For a rainbow of tubes to be drawn means that five tubes, red - blue - green - purple - gray, are drawn, often in that sequence.
[0011] It would seem that if this sequence of tubes is so common, there would be an opportunity to prepackage tubes in this way. However, the common physical mechanism of puncturing each tube requires that they be separated so that they can fit inside the needle holder. So there are really two basic problems in the current system. Tubes cannot be connected, and when they are connected they must be unconnected at some point along the chain of utilization, either at the acquisition or testing stage. There is really no practical way to create connected tubes that can travel from manufacture to lab without at least the chance that they will be unconnected.
[0012] Once tubes are filled with blood, from a practical standpoint, they must somehow be kept together to the point that they are received in the lab and ready to be analyzed. In the field this is commonly achieved with a plastic bag, a rubber band, or adhesive tape. This merely adds additional components, extra steps, and multiple opportunities for inefficiencies and errors. Tubes often get misplaced or lost.
[0013] The present disclosure is directed toward one or more of the problems set forth above.
Summary
[0014] In one aspect, an interconnecting blood collection tube includes a test tube with an inner surface that partially defines a hollow chamber, which has a reagent positioned therein. A stopper closes an open end of the test tube and defines a portion of the hollow chamber. A cap secures the stopper to the test tube. A pressure in the hollow chamber is less than a pressure on an outer surface of the test tube. One of the test tube, the cap or an added piece mounted on the test tube includes an outward facing first mateable connection surface at a first location about a longitudinal axis of the test tube, and a outward facing second mateable connection surface at a second location, which is different from the first location, about the longitudinal axis. Each of the first and second mateable connection surfaces are configured to matingly connect to a respective one of a second mateable connection surface and a first mateable connection surface of another interconnecting blood collection tube in a side by side axially parallel orientation.
[0015] In another aspect, an interconnecting set of blood collection tubes includes a first blood collection and a second blood collection tube. The first and second blood collection tubes have a connected configuration in which the blood collection tubes are in contact in a side-by-side parallel orientation, and a disconnected configuration, in which the blood collection tubes are out of contact with each other. The first mateable connection surface of the first collection tube is matingly connected to the second mateable connection surface of the second blood collection tube in the connected configuration.
[0016] In another aspect, a method of using a set of interconnecting blood collection tubes includes moving the blood collection tubes from a disconnected configuration to a connected configuration. While in a connected configuration, the stopper of the first blood collection tube is punctured with a hollow needle. Thereafter, the hollow needle is moved out of contact with the stopper of the first blood collection tube and punctures the stopper of a second blood collection tube. Thereafter, the hollow needle may be moved out of contact with the stopper of the second blood collection tube and sequentially puncture the stopper of third, fourth or more blood collection tubes before being moved out of contact with all of the blood collection tubes. This process may be done by hand, or may be at least partially mechanized.
Brief Description of the Drawings
[0017] Fig. l is a front side view of an interconnecting blood collection tube according to the present disclosure;
[0018] Fig. 2 includes several views of a cap for an interconnecting blood collection tube according to one aspect of the present disclosure;
[0019] Fig. 3 is a perspective view of an interconnecting set of blood collection tubes in a disconnected configuration;
[0020] Fig. 4 is a perspective view of the interconnecting set of blood collection tubes from Fig. 3 in a connected configuration;
[0021] Fig. 5 is a top view of the interconnecting set of blood collection tubes of Fig. 4; [0022] Fig. 6 is a front side view of the interconnecting set of blood collection tubes from Figs. 4 and 5;
[0023] Fig. 7 is a perspective view of an interconnecting set of blood collection tubes in a connected configuration positioned adjacent a puncturing machine according to another aspect of the present disclosure;
[0024] Fig. 8 is a perspective view of the set of blood collection tubes from Fig. 7 mounted in the puncturing machine according to another aspect of the present disclosure;
[0025] Fig. 9 is a partial perspective view of a pair of interconnecting blood collection tubes in a disconnected configuration showing detents according to another aspect of the present disclosure;
[0026] Fig. 10 is a top view of the blood collection tubes from Fig. 9;
[0027] Fig. 11 is a top view of the interconnecting blood collection tubes of Figs. 9 and 10 in a connected configuration with a third blood collection tube;
[0028] Fig. 12 is a perspective view of the set of blood collection tubes from Fig. 11 in an initial step for using an interconnected set of blood collection tubes according to another aspect of the present disclosure;
[0029] Fig. 13 is a side view of the interconnecting set of blood collection tubes from Fig. 12 after a first one of the blood collection tubes has been punctured by a hollow needle;
[0030] Fig. 14 is a perspective view and the method with the hollow needle preparing to puncture the stopper of a second one of the blood collection tubes;
[0031] Fig. 15 is a perspective view after the hollow needle has punctured the second one of the blood collection tubes according to a method of the present disclosure;
[0032] Fig. 16 is a perspective view showing the hollow needle being moved for puncturing a third one of the blood collection tubes;
[0033] Fig. 17 is a perspective view showing the hollow needle after puncturing the stopper of the third one of the blood collection tubes; [0034] Fig. 18 is a perspective schematic view of a puncturing machine interacting with a first one from a set of blood collection tubes according to another aspect of the present disclosure;
[0035] Fig. 19 is a top and perspective view of a blood collection tube according to another aspect of the present disclosure in which the mateable surfaces are included on an extra component mounted about the test tube;
[0036] Fig. 20 includes top and perspective views of a blood collection tube according to another aspect of the present disclosure in which the mateable surfaces are integrally formed as a portion of the test tube;
[0037] Fig. 21 includes side and perspective views of a blood collection tube according to still another aspect of the present disclosure in which the tubes move to a mated configuration along a line perpendicular to a longitudinal axis of the test tube;
[0038] Fig. 22 includes top and perspective views of a blood collection tube according to another aspect of the present disclosure in which the blood collection tubes mate via a press fit;
[0039] Fig. 23 includes top and perspective views of a blood collection tube with flat mateable connection surfaces;
[0040] Fig. 24 includes top and perspective views of a blood collection tube according to still another aspect of the present disclosure in which the mateable surfaces are round and maybe magnetic;
[0041] Fig. 25 includes top and perspective views of a blood collection tube according to another aspect of the present disclosure in which the mateable surfaces are distributed completely around the circumference of the cap;
[0042] Fig. 26 includes top and perspective views of a blood collection tube showing a configuration in which the tubes can be connected via either a press fit or via relative sliding according to another aspect of the present disclosure; and [0043] Fig. 27 includes side and perspective views of a blood collection tube according to another press fit connection strategy according to the present disclosure.
Detailed Description
[0044] The solution offered by this disclosure is two-fold. First, we propose that sample tubes be made so that they interconnect in some way, and can be connected and unconnected quickly and easily. Second, we propose that the interconnected tubes can be sequentially accessed via a specialized needle holder designed for interconnected tubes. Our proposal is to marry these two functions such that the interconnectivity also facilitates the sequential access. In other words, interconnectivity is a solution that does not necessarily cause a new problem - it provides an opportunity for more solutions.
[0045] There are many possible mechanisms for interconnecting blood tubes that fall into these basic categories:
1. Magnets.
2. Adhesives or fasteners (e.g. hook and loop)
3. Male-female mateable locking structures.
[0046] These mechanisms can be supplied by any component of the collection tubes. Ideally, the interconnecting tubes could be used in all the same ways that current tubes are used, so that no new components are required by the system.
[0047] For instance, tube pieces could contain a hook and loop system, or double-stick tape, or magnetic material could be embedded in the components.
[0048] The particular system illustrated here demonstrates a "linear" approach, where each tube has a male adaptor on one side, and a female adapter on the other. This allows for one or more tubes to be connected linearly. It is analogous to a Lego building block system. Tubes can be quickly and easily connected and unconnected. [0049] Once the tubes are linearly connected in this fashion, they provide surfaces that are utilized in sequential puncturing by specialized needle holder mechanisms. There are many possible mechanisms for this purpose. Common needle holders cannot accept connected tubes unless they are unconnected; however, connected tubes present new substrates that can be more easily utilized by mechanized needle holders.
[0050] The specific mechanism demonstrated here, called QuickDraw, utilizes a toothed drive belt that matches drive surface teeth in the tube cap. It utilizes position switches that detect a locating surface, such as a ridge, on the tube cap. It also utilizes a retaining bar that secures the tube to the mechanism via special cuts in the tube cap. This design merely replaces existing tube caps with new ones that interconnect, and mate with mechanized needle holders.
[0051] These functional features are demonstrated as features of the tube cap, but they are not limited to that component. It is also possible to add an entirely new component to collection tubes to perform any or all these functions. This disclosure anticipates all possible mechanisms for enhancing the functionality of evacuated collection tubes via interconnectivity. No prior art makes collection tubes independently interconnectable. Once tubes are interconnected - by whatever means - they are then more easily punctured sequentially by a mechanized process.
[0052] This particular device demonstrates this functionality by adding the following features to existing tube caps:
1. Male-female connectors.
2. Tube detection features.
3. Restraining apparatus to mate with needle holders.
4. Drive apparatus for sequential movements.
[0053] Referring initially to Figs. 1 and 2, an interconnecting blood collection tube 10 includes a test tube 20 with an inner surface 21 that partially defines a hollow chamber 22. A reagent 30 is positioned in the hollow chamber. Those skilled in the art will appreciate that the reagent may be any of a number of substances known in the art including anti -coagulants, sodium, heparin, potassium oxalate and others. A stopper 33 closes an open end 24 of the test tube 20 and defines a portion of the hollow chamber 22. A cap 40 secures the stopper 33 to the test tube 20. A test tube 20 according to the present disclosure includes a rounded closed end 25 opposite the open end 24, and a uniform diameter segment between the ends. A pressure in the hollow chamber 22 is less than a pressure on an outer surface 23 of the test tube.
[0054] Blood collection tube 10 includes an outward facing first mateable connection surface 50 at a first location 51 about a longitudinal axis 26 of test tube 20, and an outward facing second mateable connection surface 52 at a second location 53, which is different than the first location, about the longitudinal axis 26. In this embodiment, the cap 40 includes the first and second mateable connection surfaces 50 and 52, and the respective first location 51 and second location 53 are opposite each other on opposite sides of cap 40. Although the mateable connection surface features could be formed separately and attached to cap 40, the mateable connection surfaces are preferably integrally formed portions of the cap, which may be made from a suitable plastic material known in the art. Integrally formed means that the respective cap and connection surfaces were molded simultaneously and never had a separate identity apart from one another.
[0055] In this embodiment the first and second mateable connection surfaces 50, 52 include a slide surface 55 oriented parallel to the longitudinal axis 26 so the blood collection tube 10 can be mateably connected to a second blood collection tube 10 by moving the slide surfaces 55 along one another along the longitudinal axis 26. In this example, the second mateable connection surface 52 is not open on both ends so that it inherently includes a stop surface that contacts the first mateable connection surface 50 of a second blood collection tube when the two tubes are fully connected. Thus, the first and second mateable connection surfaces 50, 52 are configured to matingly connect to a respective one of a second mateable connection surface 52 and a first mateable connection surface 50 of another interconnecting blood collection tube in a side-by-side axially parallel orientation. Although many different shapes and structures could facilitate connecting two or more blood collection tubes to one another, the first mateable connection surface 50 in this embodiment is male 60, and the second mateable connection surface is female 61 and is sized and shaped to matingly match the male 60. Although not necessary, cap 40 may also be integrally formed to include at least one link 57 of a translational drive surface 65 that defines a drive direction 66 that is perpendicular to the longitudinal axis 26. Finally, the blood collection tube 10 may include a machine readable unique identifier 27, such as a bar code 28, attached to one of the test tube 20 and the cap 40.
[0056] Referring now in addition to Figs 3-6, five interconnecting blood collection tubes 10 may be considered a set 70 of blood collection tubes that are shown in a disconnected configuration 72 in Fig. 3 and a connected configuration 71 in Figs. 4-6. Although not readily apparent in the black and white drawings of this disclosure, the caps of the various blood collection tubes 10 may be of different colors known in the art to indicate to the user what test might be performed on any blood contained within the tube and what reagent may be present. In addition, the blood collection tubes may be of different lengths known in the art without departing from the present disclosure. Thus, in this example, each of the blood collection tubes 10 may have identically shaped caps, which may be of different colors, and may include identically shaped test tubes 20, which may be of different lengths. When the blood collection tubes 10 are in the connected configuration 71, the caps 40 of the blood collection tubes are in contact with the respective connected blood collection tubes in a side-by-side parallel orientation. In this exampled embodiment, the respective test tubes 20 remain out of contact with each other in the connected configuration 71. Those with ordinary skill in the art will appreciate that the blood collection tubes are entirely out of contact with each other in the disconnected configuration 72 as shown in Fig. 3. As best shown in Fig. 5, the set 70 of blood collection tubes 10, in the connected configuration 71, define a straight line 73 that intersects the respective longitudinal axis 26 of each of the blood collection tubes 10.
However, those skilled in the art will appreciate that alternative configurations may be desirable such as a curved or arc line passing through the respective longitudinal axis may be desirable without departing from the present disclosure. For instance, such an arc may have a radius much larger than the radius of the respective test tubes, such as maybe one foot in such an alternative connective configuration. Alternatively, the mateable connection surfaces 50, 52 may be arranged on the annular side surface 42 of the caps 40 so that a rainbow group of mated five blood collection tubes 10 may interconnect into a circle similar to a quick load configuration for a revolver firearm. Preferably, the top surfaces 41 of the respective caps 40 of the blood collection tubes 10 are flush in the connected configuration 71 as best shown in Fig. 6. In the connected configuration 71, the blood collection tubes 10 together define a plurality of links 57 of a translational drive surface 65 that defines a drive direction 66 that is perpendicular to the longitudinal axis 26 in the event that the set 70 may need to interact with a mechanized device, such as the puncturing machine described infra.
[0057] Referring now in addition to Figs. 9-11, a variation on the slide connect mateable connection surfaces includes a detent 56 rather than a stop surface as in the embodiment shown in Figs. 1-6. Thus, this embodiment differs from the earlier embodiment in that the female mateable connection surface 52 opens on opposite ends, but relies upon an interaction of detents 56 to mark the full connection of the blood collection tubes 10 so that their top surfaces are flush when the detents 56 are in contact with one another. Nevertheless, slidable mateable connection surfaces without stop surfaces or detents could also fall within the intended scope of the present disclosure. [0058] Referring now in addition to Figures 19-27, a variety of different shapes and strategies for interconnecting blood collection tubes 10 are illustrated. Fig.
19 is of interest for showing blood collection tube 10 including a separate component 67 that may be mounted on test tube 20. Component 67 may include the first and second mateable connection surfaces 50, 52. Thus, the embodiment of Fig. 19 differs from currently available blood collection tubes 10 only by the inclusion of the extra mating component 67, which may be formed of a plastic similar to that of the cap 40, or be molded from another suitable material known in the art. Fig. 20 is of interest for showing the mateable connection surfaces 50, 52 integrally formed as portions of the test tube 20 of blood collection tube 10. Fig. 21 is of interest for showing a slide mateable connection surface
configuration in which two tubes slide along a line perpendicular to the longitudinal axis 26, rather than along the longitudinal axis as in the embodiment of Figs. 1-6. Fig. 22 is of interest for showing a configuration that permits a press fit connection in which the first and second mateable connection surfaces 50, 52 slightly deform while being pressed together, before maybe resiliently assuming their original shape that causes the two blood collection tubes 10 to remain connected. Fig. 23 is of interest for showing mateable first and second connection surfaces 50, 52 that may lay in a plane to facilitate use of adhesives, hook and loop fasteners or maybe even magnets, as shown, to facilitate connection between two or more blood collection tubes 10. Fig. 24 is of interest for showing that the first and second mateable connection surfaces 50, 52 may both be convex in shape and still be interconnecting, such as by incorporating magnetic features into cap 40, and/or adhesives or maybe even hook and loop fasteners. Fig. 25 is of interest for showing another press fit configuration for first and second mateable connection surfaces 50, 52, which are shown distributed completely around the annular side surface 42 of cap 40 so that blood collection tubes may be joined together in a clustered bunch rather than along a line as shown in the embodiment of Figs. 1-6. Fig. 26 is of interest for showing a shape that may facilitate either press fit or slide fit, and includes first and second mateable connection surfaces distributed completely around the annular side surface 42 of cap 40 so that any one blood collection tube 10 may be self connected to two or more other like shaped blood collection tubes 10 in a clustered bunch or in a line. Finally, Fig. 27 shows still another configuration in which the first and second mateable connection surfaces 50 and 52 are distributed completely around cap 40 and may permit blood collection tubes to be connected in a configuration other than a side-by-side parallel orientation as discussed previously, with the connection being facilitated via a press fit.
Industrial Applicability
[0059] The present disclosure finds general applicability in blood collection tubes. The present disclosure find particular applicability in associating a plurality of blood collection tubes for one patient at the time of blood collection. In addition, the present disclosure might also enable some automation or mechanization in the blood collection process, and may further facilitate processing and testing after blood collection.
[0060] Referring now to Figs. 7, 8 and 18, a set 70 of blood collection tubes in a connected configuration 71 may be used with a machine, such as puncturing machine 90 to automate and hasten a blood collection procedure. Puncturing machine 90 may include a needle holder 94 that is shown with a hollow needle 80 mounted therein which is connected to a conventional butterfly needle 95, that may be connected with a patient's vein in a conventional manner. Puncturing machine 90 may include a needle reciprocator 93 that moves hollow needle 80 into and out of contact with the respective stopper of one blood collection tube 10 in the set 70 while a drive mechanism 91 may move the set 70 via interaction with a translational drive surface 65 (Figs. 5 and 6) to move the set 70 to sequentially puncture the stopper of each respective blood collection tube 10 in set 70. Finally, puncturing machine 90 might also include a code scanner 92 to read a unique machine readable code attached to each blood collection tube 10, and maybe associate all of the unique identifiers in the set 70 with an individual patient to further avoid errors. Puncturing machine 90 might also detect a locating surface 54 (Fig. 2) to stop the set 70 for each puncturing step.
[0061] Referring now to Figs. 12-17, a by-hand method of using a set of interconnecting blood collection tubes 10 is illustrated. First, the blood collection tubes 10 are moved from a disconnected configuration 72 as shown in Fig. 3 to a connected configuration 71 as shown in Fig. 12. The user may then hold an outer slotted guard portion 81 of a blood draw set that conceals a hollow needle 80 with one hand, while holding the set 70 of blood collection tubes in their opposite hand. First, the hollow needle 80 is aligned with a first one of the blood collection tubes 10 and then the hollow needle is moved as shown in Fig. 13 to puncture the stopper of the first blood collection tube 10 to allow blood to flow therein. Next, the hollow needle 80 is moved out of contact with the first blood collection tube and aligned with the second blood collection tube 10 as shown in Fig. 14. Next, the hollow needle 80 is moved to puncture the stopper of the second blood collection tube 10 as shown in Fig. 15 to collect blood in the second blood collection tube 10. Thereafter, the hollow needle 80 is moved out of the second blood collection tube 10 and aligned with the third blood collection tube 10 as shown in Fig. 16. Finally, the hollow needle 80 is moved to puncture the stopper of the third blood collection tube 10 to allow blood to be collected in the third blood collection tube. Thereafter, the hollow needle 80 is moved out of contact with the set 70 of blood collection tubes with the blood collection procedure being completed.
[0062] The blood collection tubes 10 augments the standard practice of using the vacutainer system of drawing blood. It serves two primary functions within that system:
1. It provides a mechanism for binding blood tubes together. 2. It provides a substrate for mechanically puncturing the tubes in sequential fashion.
[0063] Other advantages and potential uses for the interconnected blood collection tubes 10 of the present disclosure may become readily apparent to those with skill in the art.
[0064] It should be understood that the above description is intended for illustrative purposes only, and is not intended to limit the scope of the present disclosure in any way. Thus, those skilled in the art will appreciate that other aspects of the disclosure can be obtained from a study of the drawings, the disclosure and the appended claims.

Claims

Claims What is claimed is:
1. An interconnecting blood collection tube comprising:
a test tube with an inner surface that partially defines a hollow chamber; a reagent positioned in the hollow chamber
a stopper closing an open end of the test tube and defining a portion of the hollow chamber;
a cap securing the stopper to the test tube;
wherein a pressure in the hollow chamber is less than a pressure on an outer surface of the test tube;
wherein one of the test tube and the cap includes a outward facing first mateable connection surface at a first location about a longitudinal axis of the test tube and a outward facing second mateable connection surface at a second location, which is opposite to the first location, about the longitudinal axis of the test tube;
wherein each of the first and second mateable connection surfaces are configured to matingly connect to a respective one of a second mateable connection surface and a first mateable connection surface of another
interconnecting blood collection tube in a side by side axially parallel orientation.
2. The interconnecting blood collection tube of claim 1 wherein the first and second mateable connection surfaces are integrally formed portions of the cap.
3. The interconnecting blood collection tube of claim 2 wherein each of the first and second mateable connection surfaces include a slide surface oriented parallel to the longitudinal axis.
4. The interconnecting blood collection tube of claim 3 wherein the first and second mateable connection surfaces include relative axial position detents.
5. The interconnecting blood collection tube of claim 2 wherein the first mateable connection surface is male and the second mateable connection surface is female that is sized and shaped to matingly match the male.
6. The interconnecting blood collection tube of claim 2 wherein the cap includes at least one link of a translational drive surface that defines a drive direction that is perpendicular to the longitudinal axis.
7. The interconnecting blood collection tube of claim 1 including a machine readable unique identifier attached to one of the test tube and the cap.
8. An interconnecting set of blood collection tubes comprising:
a first blood collection tube;
a second blood collection tube;
each of the first and second blood collection tubes includes a test tube with an inner surface that partially defines a hollow chamber; a reagent positioned in the hollow chamber; a stopper closing an open end of the test tube and defining a portion of the hollow chamber; a cap securing the stopper to the test tube; and wherein a pressure in the hollow chamber is less than a pressure on an outer surface of the test tube;
the first and second blood collection tubes have a connected
configuration, in which the blood collection tubes are in contact in a side by side parallel orientation, and a disconnected configuration, in which the blood collection tubes are out of contact with each other; wherein one of the test tube and the cap of each of the blood collection tubes includes a outward facing first mateable connection surface at a first location about a longitudinal axis of the test tube and a outward facing second mateable connection surface at a second location about the longitudinal axis of the test tube;
wherein the first mateable connection surface of the first blood collection tube is matingly connected to the second mateable connection surface of the second blood collection tube in the connected configuration.
9. The interconnecting set of blood collection tubes of claim 8 including a third blood collection tube that includes a test tube with an inner surface that partially defines a hollow chamber; a reagent positioned in the hollow chamber; a stopper closing an open end of the test tube and defining a portion of the hollow chamber; a cap securing the stopper to the test tube; wherein a pressure in the hollow chamber is less than a pressure on an outer surface of the test tube; and wherein one of the test tube and the cap includes a outward facing first mateable connection surface at a first location about a longitudinal axis of the test tube and a outward facing second mateable connection surface at a second location about the longitudinal axis of the test tube;
wherein the first mateable connection surface of the second blood collection tube is matingly connected to the second mateable connection surface of the third blood collection tube in the connected configuration.
10. The interconnecting set of blood collection tubes of claim 9 wherein a straight line intersects the longitudinal axes of the first, second and third blood collection tubes in the connected configuration.
11. The interconnecting set of blood collection tubes of claim 9 wherein the first and second mateable connection surfaces are integrally formed portions of the cap of the respective first, second and third blood collection tubes.
12. The interconnecting set of blood collection tubes of claim 9 wherein the third blood collection tube is shorter than at least one of the first and second blood collection tubes; and
a top surface of the respective caps of the first, second and third blood collection tubes are flush in the connected configuration.
13. The interconnecting set of blood collection tubes of claim 9 wherein the respective caps of the first, second and third blood collection tubes are different colors.
14. The interconnecting set of blood collection tubes of claim 9 wherein, in the connected configuration, the first, second and third blood collection tubes together define a plurality of links of a translational drive surface that defines a drive direction that is perpendicular to the longitudinal axes.
15. The interconnecting set of blood collection tubes of claim 9 including a machine readable unique identifier attached to one of the test tube and the cap of each of the respective first, second and third blood collection tubes.
16. A method of using a set of interconnecting blood collection tubes that includes a set of at least three blood collection tubes that each includes a test tube with an inner surface that partially defines a hollow chamber; a reagent positioned in the hollow chamber; a stopper closing an open end of the test tube and defining a portion of the hollow chamber; a cap securing the stopper to the test tube; a pressure in the hollow chamber is less than a pressure on an outer surface of the test tube; one of the test tube and the cap of each of the blood collection tubes includes a outward facing first mateable connection surface at a first location about a longitudinal axis of the test tube and a outward facing second mateable connection surface at a second location about the longitudinal axis of the test tube, the method comprising the steps of:
moving the blood collection tubes from a disconnected configuration, in which the blood collection tubes are out of contact with each other, to a connected configuration, in which the blood collection tubes are connected to each other with each of the blood collection tubes being in contact with, and connected to, at least one other of the blood collection tubes in a side by side parallel orientation;
puncturing the stopper of a first one of the blood collection tubes with a hollow needle in the connected configuration;
moving the hollow needle out of contact with the stopper of the first one of the blood collection tubes in the connected configuration;
puncturing the stopper of a second one of the blood collection tubes, which is in contact with the first one of the blood collection tubes, with the hollow needle in the connected configuration;
moving the hollow needle out of contact with the stopper of the second one of the blood collection tubes in the connected configuration;
puncturing the stopper of a third one of the blood collection tubes, which is in contact with the second on of the blood collection tubes, with the hollow needle in the connected configuration;
moving the hollow needle out of contact with the stopper of the third one of the blood collection tubes in the connected configuration;
wherein the first mateable connection surface of the first one of blood collection tubes is matingly connected to the second mateable connection surface of the second one of the blood collection tubes in the connected configuration, and the first mateable connection surface of the second one of the blood collection tubes is matingly connected to the second mateable connection surface of the third one of the blood collection tubes in the connected configuration.
17. The method of claim 16 wherein a straight line intersects the longitudinal axes of the first one, second one and third one of the blood collection tubes in the connected configuration.
18. The method of claim 17 including mounting the set of blood collection tubes in a puncturing machine, to which the hollow needle is attached, when in the connected configuration; and
moving the set of blood collection tubes with the puncturing machine, while in the connected configuration, perpendicular to a longitudinal axis of each of the blood collection tubes between each of the puncturing steps.
19. The method of claim 16 including positioning top surfaces of the caps of the blood collection tubes flush with each other in the connected configuration; and
wherein the positioning step includes at least one of engaging a detent and contacting a stop surface.
20. The method of claim 19 wherein the cap of the first one of the blood collection tubes is slid in contact with the cap of the second one of the blood collection tube along a longitudinal axis during the positioning step.
PCT/US2019/047174 2018-08-25 2019-08-20 Interconnecting blood collection tubes WO2020060708A2 (en)

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Publication number Priority date Publication date Assignee Title
DE1575122C3 (en) * 1967-06-22 1975-02-13 Eppendorf Geraetebau Netheler & Hinz Gmbh, 2000 Hamburg Holder for mainly cylindrical vessels
EP0414644A3 (en) * 1989-08-25 1991-08-28 Greiner Vibrograf Ag Chain fashioned holding device having tubes for holding a tubular vessel each
US5137693A (en) * 1990-07-30 1992-08-11 Miles Inc. Spring biased test tube holder
JP4542287B2 (en) * 2000-03-31 2010-09-08 シスメックス株式会社 Reagent container opening / closing unit and barcode attaching unit
US9423409B2 (en) * 2012-04-30 2016-08-23 Siemens Healthcare Diagnostics Inc. Articulated sample container rack apparatus, rack conveyor systems, and methods of conveying sample containers
CN105050719B (en) * 2013-03-06 2018-10-19 凯杰有限公司 Method for chemistry, the pipe of biology or biotechnology substance, tube apparatus, the bracket used in tube apparatus, the application of pipe and formation pipe

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