CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provision Application Serial No. 63/183,195 filed May 3, 2021, the contents of which is hereby incorporated by reference as if set forth in its entirety herein.

BACKGROUND OF THE DISCLOSURE

Blood draws are frequently utilized to assess the health of animals. Existing blood draws require a user to grasp and hold a syringe with one hand while moving a plunger relative to the syringe with the other hand. It can be challenging to accurately control a volume of a blood draw when utilizing a syringe with two hands. Therefore, a need exists for an improved blood draw syringe.

SUMMARY

A blood-draw controller can include a first attachment member, an offset member, a second attachment member, and a biasing member. The first attachment member can be coupled to a syringe. The offset member can be coupled to the first attachment member. The offset member can include a bore. The second attachment member can be movably coupled to the offset member. The second attachment member can be adapted to couple with a syringe plunger. The biasing member can be configured to bias the second attachment member and the plunger of the syringe away from the syringe.

The first attachment member can comprise a split barrel. The first attachment member can have a complementary profile to the flange of the syringe. The first attachment member can have a recess sized and shaped to receive the flange of the syringe. The biasing member can be a compression member. The biasing member can be a tension member. The first attachment member can include a sidewall defining a recess to receive a portion of the syringe. The sidewall can include a first end and a second end resiliently movable relative to the second end such that the portion of the syringe can move into the recess and the sidewall at least partially envelops the portion of the syringe. The syringe can include a barrel adapted to receive a fluid, the syringe plunger movable relative to the barrel to draw fluid into the barrel. The blood-draw controller can be detachably coupled to the syringe. The bore can be disposed about a central axis that can be configured to be parallel with a longitudinal axis of the syringe when the first attachment member can be coupled to the syringe. The offset member can be fixed relative to the first attachment member. The second attachment member can include a controller plunger coupled to the plunger of the syringe. The second attachment member can be slidably received within the bore of the offset member. The syringe can include a distal end and a proximal end spaced from the distal end along a central axis, the biasing member positioned proximally to the proximal end of the syringe.

A method of drawing blood with a blood-draw controller can include identifying a syringe including a barrel adapted to receive a fluid, a syringe plunger movable relative to the barrel to draw fluid into the barrel, and a flange. The method can include coupling a first attachment member of the blood-draw controller to the barrel of the syringe. The method can include coupling a second attachment member of the blood-draw controller to the syringe plunger. The method can include moving the second attachment member relative to the first attachment member. The method can include causing the blood-draw controller to move the syringe plunger relative to the barrel to draw fluid into the barrel.

Moving the second attachment member relative to the first attachment member can include manually moving the second attachment member and the syringe plunger relative to the barrel. In a further embodiment, the method includes detaching the first attachment member from the barrel of the syringe and detaching the second attachment member from the syringe plunger. The method can include identifying a second syringe including a barrel adapted to receive a fluid, a plunger movable relative to the barrel to draw fluid into the barrel, and a second syringe flange. The method can include coupling the first attachment member to the barrel of the second syringe and coupling the second attachment member to the plunger of the second syringe. The method can include moving the second attachment member relative to the first attachment member. The method can include causing the blood-draw controller to move the second syringe plunger relative to the barrel to draw fluid into the barrel. In a further embodiment, the method includes moving the syringe plunger relative to the barrel to eject the fluid from the barrel into a container while the blood-draw controller can be coupled to the syringe. In a further embodiment, the method includes detaching the blood-draw controller from the syringe and moving the syringe plunger relative to the barrel to eject the fluid from the barrel into a container. BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and desired objects of the present disclosure, reference is made to the following detailed description taken in conjunction with the accompanying drawing figures wherein like reference characters denote corresponding parts throughout the several views.

FIGS. 1A-1C provide cross-sectional views of a controller engaged with a syringe according to an embodiment of the disclosure. FIG. 1 A depicts the assembly in a first position in which the second attachment member and the plunger are biased proximally. FIG. IB depicts the assembly in a second position in which the second attachment member and the plunger are advanced distally. FIG. 1C depicts the assembly in a third position in which the second attachment member and the plunger are biased proximally after drawing fluid into the barrel of the syringe.

FIG. 2 provides a perspective view of a controller according to an embodiment of the disclosure.

FIG. 3 depicts a method of using a syringe and/or controller according to an embodiment of the disclosure.

DEFINITIONS

The instant disclosure is most clearly understood with reference to the following definitions.

As used herein, the singular form “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

Unless specifically stated or obvious from context, as used herein, the term “about” is understood as within a range of normal tolerance in the art, for example within 2 standard deviations of the mean. “About” can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless otherwise clear from context, all numerical values provided herein are modified by the term about.

As used in the specification and claims, the terms “comprises,” “comprising,” “containing,” “having,” and the like can have the meaning ascribed to them in U.S. patent law and can mean “includes,” “including,” and the like. Unless specifically stated or obvious from context, the term “or,” as used herein, is understood to be inclusive.

The terms “proximal” and “distal” can refer to the position of a portion of a device relative to the remainder of the device or the opposing end as it appears in the drawing. The proximal end can be used to refer to the end manipulated by the user. The distal end can be used to refer to the end of the device that is inserted and advanced and is furthest away from the user. As will be appreciated by those skilled in the art, the use of proximal and distal could change in another context, e.g. , the anatomical context in which proximal and distal use the patient as reference, or where the entry point is distal from the user.

Ranges provided herein are understood to be shorthand for all of the values within the range. For example, a range of 1 to 50 is understood to include any number, combination of numbers, or sub-range from the group consisting 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,

16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41 42, 43, 44, 45, 46, 47, 48, 49, or 50 (as well as fractions thereof unless the context clearly dictates otherwise).

DETAILED DESCRIPTION OF THE EMBODIMENTS

Aspects of the disclosure provide blood-draw controllers and syringes. Embodiments of the disclosure can improve accuracy ( e.g ., blood volume), speed, and/or ease (e.g, by enabling single-handed use).

Referring now to FIGS. 1 A-2, an embodiment of a blood-draw controller 100 is provided. The controller 100 includes a first attachment member 102, an offset member 104, a second attachment member 106, and a biasing member 108.

The first attachment member 102 and the offset member 104 can be fixedly coupled by an arm 202 depicted in FIG. 2. The distance between the proximal surface of the first attachment member 102 and the distal surface of the offset member 104 determines the axial travel of the plunger and, thus, defines the volume of the blood draw. The distance and resulting volume can be varied between controllers to accommodate clinical needs.

The arm 202 can include a body 203 with a first strut 205 coupled to the body 203. The arm 202 and the body 203 can be a unitary construct. A longitudinal axis of the body 203 can be parallel to a longitudinal axis AL of a syringe 110 when the arm 202 is coupled to the syringe 110. The first strut 205 can extend from a proximal end of the body 203. The first strut 205 can extend proximally of the proximal end of the body 203. The first attachment member 102 can be coupled to the first strut 205. The first attachment member 102 can extend proximally of the proximal end of the first strut 205. The first strut 205 can extend in a lateral direction, perpendicular to the longitudinal axis of the body 203, such that the body 203 is laterally spaced from the syringe 110 when the arm 202 is coupled to the syringe 110. The arm 202 can be laterally spaced from the syringe 110 during use to provide clearance between any moving parts and the arm 202. In some embodiments, a user can grasp the controller 100 by the arm 202 during use.

The first attachment member 102 is adapted and configured to couple with a syringe 110, e.g ., at a portion such as a barrel, a flange, and the like. The syringe 110 may have a proximal end 111 and a distal end 113 opposite the proximal end.

The syringe 110 can have a barrel 112 disposed between the proximal end 111 and the distal end 113. The barrel 112 can define a chamber adapted to receive a fluid (e.g, blood). A flange 114 may be disposed on the barrel 112. The flange 114 may be disposed at or adjacent to the proximal end 111, or, alternatively between the proximal end 111 and the distal end 113. A longitudinal axis AL can extend through the syringe 110 through at least the proximal end 111 and the distal end 113. A plunger 120 can be movable within the barrel 112, with at least a portion of the plunger 120 being movable along the longitudinal axis AL between the proximal end 111 and the distal end 113 of the barrel 112. A needle 122 can be disposed at, or adjacent to, the distal end 113 of the syringe 110. In other embodiments, the distal end 113 of the barrel 112 includes a coupling element (e.g, Luer lock) adapted to couple to another element in fluid connection with a patient’s vein. For example, the coupling element can couple to a catheter, indwelling arterial or central venous line or intravenous line. The needle 122 can be affixed to the barrel 112 and be in fluid communication with the barrel 112. The needle 122 can be disposed between the barrel 112 and the distal end 113 of the syringe 110. The syringe 110 can include a flange 118 operably connected with the plunger 120 and configured to cause the plunger 120 to move proximally and/or distally within the barrel 112. The flange 118 may be disposed at, or adjacent to, the proximal end 111 of the syringe 110. The flange 118 can extend laterally from a central portion of the plunger 120 The coupling of the first attachment member 102 can be mechanical ( e.g ., frictional, interference, compression, and the like), chemical (e.g., adhesive), and the like. For example, the first attachment member 102 can be a split barrel, bushing, or sleeve that can expand slightly to fit over a barrel 112 of the syringe 110 when pressed laterally against the syringe 110, e.g, against the barrel 112 in a direction orthogonal to the longitudinal axis AL. The first attachment member can include a sidewall 211 that defines a recess to receive the barrel 112. The sidewall can include a first end 213 and a second end 215 moveable relative to each other to allow the barrel 112 to be positioned within the recess defined by the sidewall 211. The first attachment member 102 can be resilient such that the first attachment member 102 returns to its original shape after the first end 213 and second end 215 move relative to each other.

In another example, the first attachment member 102 can have a complementary geometry to the flange 114 of the syringe 110 and be pressed laterally onto the flange 114, e.g, in a direction orthogonal to the longitudinal axis AL. For example, the first attachment member 102 can define a recess that receives the flange 114 of the syringe.

A second strut 207 can connect the body 203 of the arm 202 to the offset member 104. The second strut 207 and the body 203 can be a unitary construct. The second strut 207 can extend in the lateral direction between the body 203 and the offset member 104 such that the body 203 is laterally spaced from the syringe 110 during use.

The offset member 104 can include a bore 116 adapted to receive the second attachment member 106. The offset member 104 can be substantially parallel with the longitudinal axis AL of the syringe when the first attachment member 102 is engaged with the syringe 110. The bore 116 can be configured to be coaxial with the syringe 110. As depicted in FIGS. 1 A and 1C, the offset member 104 is configured to contact the second attachment member 106 when the second attachment member 106 is moved in the proximal direction toward the offset member 104. The offset member 104 may preclude at least a portion of the second attachment member 106 from moving past the offset member 104 in the proximal direction, thus defining a proximal-most position of the second attachment member 106. This arrangement can limit proximal movement of the second attachment member 106 and the plunger 120, thereby drawing a controlled volume of fluid. The second attachment member can include a dog bone shape. The second attachment member 106 can include a proximal flange, a distal flange, and a central portion extending from the proximal flange to the distal flange. The central portion can have a smaller cross-sectional dimension that the proximal flange and the distal flange such that eh central portion is maintained within the bore 116. The offset member 104 can be rigid. The offset member 104 can be rigid and the first attachment member 102 can be flexible.

The second attachment member 106 can be slidably received within the bore 116 of the offset member 104 and adapted and configured for coupling with the flange 118 of the syringe 110. Such coupling can be mechanical ( e.g ., frictional, interference, compression, and the like), chemical (e.g., adhesive), and the like. For example, the second attachment member 106 can have a recess complementary geometry to the flange 118 of the syringe 110 such that the second attachment member 106 can be pressed laterally onto the flange 118.

The biasing member 108 is adapted and configured to bias the second attachment member 106 (and thereby the flange 118 and the plunger 120) away from the syringe 110. Movement of the plunger 120 away from the syringe 110 (or proximally) creates a vacuum in the barrel 112 of the syringe 110 distal to the plunger 120 and draws a fluid (e.g, blood) into the syringe 110 through the distal end 113 of the syringe 110 (e.g, through the needle 122, Luer- style blood port, and the like). The biasing member 108 facilitates single-handed use by allowing the user to hold the barrel 112 of the syringe 110 (e.g, between two or more fingers) while moving the second attachment member 106 distally relative to the barrel 112 (e.g, before engaging the fluid source) by applying a loading force thereto. The second attachment member 104 can be moved by depressing with a thumb. The initial movement of the second attachment member 106 can move the biasing member 108 from a relaxed configuration to a ready configuration. The biasing member 108 can be compressed in the ready configuration. The biasing member 108 can move the second attachment member 106 (and thereby the plunger 120) proximally away from the syringe 110 when the loading force is removed, thereby drawing fluid (e.g, blood) into the syringe 110. Exemplary biasing members 108 include springs (e.g, compression, tension, torsional,), elastomers, magnets, gas-piston cylinders, and the like.

The biasing member 108 can optionally be omitted to provide a controlled-volume device in which the second attachment member 106 can be withdrawn proximally by the user.

Although FIGS. 1 A-1C depict a controller that can be coupled to existing syringes, embodiments of the disclosure can also be manufactured to be integral with a syringe 110 (e.g, in which the first attachment member 102 could be integrally molded with the barrel 112). The syringe 110 can have a variety of features. In some embodiments, the syringe 110 can be a zero-dead-volume syringe, in which the plunger 120 includes a distal geometry complementary to the needle 122 that displaces air from the needle 122 when the plunger 120 is advanced distally. The first attachment member 102 can be adapted to receive a variety of syringe sizes.

The syringe 110 can have a variety of volumes, e.g ., 1 cc (1,000 pL). The arm 202 can be detachably coupled to the syringe 110. The arm 202 can be coupled to a first syringe 110 during a first blood draw. The arm 202 can be detached from the first syringe 110 after the first blood draw. The arm 202 can then be coupled to a second syringe 110 and utilized to complete a second blood draw. The volume of the first blood draw can be the same as the volume of the second blood draw. In other embodiments, the volume of the first blood draw is different than the volume of the second blood draw. The second syringe 110 can have a dimension that is different from the first syringe 110. For example, a diameter of the barrel 112 of the first syringe 110 can be different than a diameter of the barrel 112 of the second syringe 110.

The components described herein can be fabricated from a variety of biocompatible materials such as polymers, glass, metal, ceramics, and the like. Exemplary polymers include thermoplastic polymers, thermoset polymers, polycarbonate, polystyrene, PEEK (poly-ether- ether-ketone), PES (poly-ether-sulfone), ABS (acrylonitrile butadiene styrene), polypropylene, polymethylpentene, polycarbonate, acetal products, polytetrafluoroethylene (PTFE) (e.g, TEFLON® available from The Chemours Company of Wilmington, Delaware), polysulfone products, DELRIN® acetal resin available from E. I. du Pont de Nemours and Company of Wilmington, Delaware, and the like.

Components of the systems described herein can be fabricated using a variety of techniques including casting, molding, machining, thermomolding, thermosetting, injection molding, vacuum forming, additive manufacturing (also known as 3D printing), and the like.

Referring now to FIG. 3, another aspect of the disclosure provides a method 300 of drawing a fluid such as blood. The steps can be performed in a variety of orders.

In step S302, a system as described herein is provided in a first position so that plunger is biased proximally.

In step S304, the second attachment member is pressed distally, e.g, with the user’s thumb to advance the plunger distally and expel air from the syringe. In step S306, the syringe is engaged with a vessel ( e.g ., an anatomical vessel, an anatomical blood vessel, tubing, blood draw port, and the like). Engagement can be through piercing the vessel or a septum with a needle. The second attachment member can remain distally pressed during engagement.

In step S308, the second attachment member is released and the biasing member biases the second attachment member proximally to draw fluid into the barrel of the syringe.

In step S310, the syringe is withdrawn from the vessel.

In step S312, the second attachment member can be pressed distally again to expel the fluid into another container. In some embodiments, the syringe can be detached from the controller 100 prior to expelling the fluid into the container.

The method can be performed by a single person. The method can be preformed by a user with one hand.

It is to be appreciated that certain features of the invention which are, for clarity, described herein in the context of separate embodiments, may also be provided in combination in a single embodiment. That is, unless obviously incompatible or specifically excluded, each individual embodiment is deemed to be combinable with any other embodiment s) and such a combination is considered to be another embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any sub-combination. Finally, while an embodiment may be described as part of a series of steps or part of a more general structure, each said step may also be considered an independent embodiment in itself, combinable with others.

It should be understood that the steps of the exemplary methods set forth herein are not necessarily required to be performed in the order described, and the order of the steps of such methods should be understood to be merely exemplary. Likewise, additional steps may be included in such methods, and certain steps may be omitted or combined, in methods consistent with various embodiments of the present invention. Although the elements in the following method claims, if any, are recited in a particular sequence with corresponding labeling, unless the claim recitations otherwise imply a particular sequence for implementing some or all of those elements, those elements are not necessarily intended to be limited to being implemented in that particular sequence.