NEEDLE DEVICES WITH BISTABLE STRUCTURE AND RELATED METHODS

Abstract

A needle guard located in a first hub and the combination mounted over a needle of a second hub having a shaft, a needle tip, and a change in profile located proximal of the needle tip. The needle guard has a proximal wall having a perimeter defining an opening therein, a first arm extending distal the proximal wall, and a second arm extending distal the proximal wall opposite the first arm. The first arm and the second arm are spaced from the needle in a ready to use position. The first arm, the second arm, or both arms covering the needle tip in a protective position when the needle guard is triggered by an activator.

Claims

1. A needle device, comprising: a first hub having a body defining an interior cavity and having a proximal opening; a second hub; a needle extending distally of the second hub and through the first hub in a ready to use position, said needle comprising a shaft, a needle tip, and a change in profile proximal of the needle tip; a needle guard located in the interior cavity of the first hub, said needle guard comprising a proximal wall having a perimeter defining an opening having the needle passing therethrough, a first arm extending distally of the proximal wall and having a width and a second arm extending distally of the proximal wall opposite the first arm and having a width; and wherein the first arm and the second arm are spaced from the needle in the ready to use position and the needle guard is in a first configuration, and wherein at least the first arm covers the needle tip in a protective position and the needle guard is in a second configuration when the needle guard is activated and part of the width of the first arm, the second arm, or both the first and the second arms change from a first shape to a second shape having less of a curved surface.

2. The needle device of claim 1, further comprising an activator for activating the needle guard to change from the first configuration to the second configuration.

3. The needle device of claim 2, wherein the activator is press fitted into the interior cavity of the first hub.

4. The needle device of claim 2, wherein the activator is located inside the interior cavity and prevented from moving proximally by a projection extending from an interior surface of the interior cavity.

5. The needle device of claim 4, wherein the projection is an annular ring.

6. The needle device of claim 2, wherein the activator has a tapered bore.

7. The needle device of claim 6, wherein the activator has a rectangular bore.

8. The needle device of claim 1, wherein the first shape of the first arm and the second arm comprises an arcuate surface formed along one or more activating portions.

9. The needle device of claim 8, wherein the arcuate surface is concave.

10. The needle device of claim 8, wherein the arcuate surface is convex.

11. The needle device of claim 8, wherein the one or more activating portions of the first arm and the second arm coil towards the needle in the second configuration to cover the needle tip.

12. The needle device of claim 8, wherein a distal extension extends distally from the first arm.

13. The needle device of claim 12, wherein the distal extension is parallel to the first arm.

14. The needle device of claim 8, wherein one or more sidewalls extend from opposite sides of the first arm.

15. The needle device of claim 14, wherein gaps are provided between the one or more sidewalls.

16. The needle device of claim 1, wherein the needle is a fistula needle.

17. The needle device of claim 1, further comprising a tether having a first end attached to the first hub.

18. A method of forming a needle device, the method comprising: providing a needle device of claim 1.

19. A method of using a needle device, the method comprising: providing a needle device having a needle hub with a needle having a change in profile and a needle guard having a perimeter defining a proximal opening slidably mounted on the needle; said needle guard comprising a first arm and a second arm; engaging the change in profile with the proximal opening; and triggering at least one of the first arm and the second arm to coil towards the needle by engaging the first arm and the second arm with an activator.

20. The method of claim 19, further comprising a catheter hub and a catheter tube and wherein the activator is located inside an interior of the catheter hub.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0374] These and other features and advantages of the present devices, systems, and methods will become appreciated as the same becomes better understood with reference to the specification, claims and appended drawings wherein:

[0375] FIG. 1A is a cross-sectional side view of a needle device with a needle guard in a ready to use position;

[0376] FIG. 1B is a sectional end-view taken along line 1B-1B of FIG. 1A, with the needle removed for clarity;

[0377] FIG. 2A is a plan view of the needle guard in an unfolded state, showing the body before folding;

[0378] FIG. 2B is an end view of the body of FIG. 2A in an extended configuration showing an arc-shaped width;

[0379] FIG. 2C is a side view of the body of FIG. 2A in a coiled configuration;

[0380] FIG. 3A is a close-up side view of the needle guard in the needle device of FIG. 1A with the needle retracted from the ready to use position and before the needle tip enters the needle guard;

[0381] FIG. 3B is a perspective view of the needle device of FIG. 3A with the needle guard retracted from the ready to use position;

[0382] FIG. 4A is a front view of the needle device in a protective position; and

[0383] FIG. 4B is a perspective view of the needle device of FIG. 4A in the protective position.

[0384] FIG. 5 is a cross-sectional side view of a fistula needle provided in accordance with aspects of the present disclosure.

[0385] FIGS. 6A-6C show different modes or configurations for activating a needle guard.

[0386] FIG. 7A and 7B are schematic drawings showing the needle guard of the present disclosure usable to contain or seal off a needle bevel to restrict or limit fluid flow.

DETAILED DESCRIPTION

[0387] The detailed description set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of needle devices and their components provided in accordance with aspects of the present assemblies, systems, and methods and is not intended to represent the only forms in which the present devices, systems, and methods may be constructed or utilized. The description sets forth the features and the steps for constructing and using the embodiments of the present assemblies, systems, and methods in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and structures may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the present disclosure. As denoted elsewhere herein, like element numbers are intended to indicate like or similar elements or features.

[0388] With reference now to FIG. 1A, a cross-sectional side view of an embodiment of a needle device 100, such as an over-the-needle catheter assembly or an IV catheter assembly, provided in accordance with aspects of the present disclosure is shown. FIG. 1A shows the needle device 100 in an installed or ready to use position in which a needle tip 110 of a needle 104 extends distally of a distal end 107 of the catheter tube 108 for accessing the vasculature of a patient. In an example, the needle device 100 comprises a first hub 106 having a hub body with a proximal end 130, an interior cavity 120, a catheter tube 108 extending distally from a distal end of the catheter hub 106, a second hub 102 attached to the proximal end 130 and having a cannula or needle 104 extending distally of the needle hub 102 and projecting through the proximal end 130 and the catheter tube 108 and having the needle tip 110 extending distally of a distal opening of the catheter tube 108. The first hub can be a catheter hub and the second hub can be a needle hub. A needle guard or spring clip 122 is slidably positioned on the needle 104 and can be located in the interior cavity 120 of the catheter hub 106 in the ready to use position. A trigger or activator 140 can be located in the interior cavity 120 distal of the Luer taper of the catheter hub 106. A proximal end of the catheter tube 108 can attach to the catheter hub 106 using a bushing 144 or other conventional means. As used herein, the term distal means an end closer to the needle tip 110 and the term proximal is the end farther away.

[0389] In the ready position, the needle 104 projects distally from a nose section 102a of the needle hub 102 through the catheter hub 106. The needle 104 has a needle tip 110 extending out a distal end 107 of the catheter tube 108, as previously described. A proximal end of the needle 104 can extend into a flashback chamber 103 of the needle hub 102, which has an opening at a proximal end 102b that can be closed by a vent plug 133. Optionally, the vent plug can have sampling features that allow blood to be collected and dispensed, such as on a glucose strip or a Petri disc. An exemplary blood stopper can be similar to the blood stopper disclosed in pending U.S. patent application Ser. No. 14/576,802, filed Dec. 19, 2014, the contents of which are expressly incorporated herein by reference.

[0390] The needle tip 110 is configured for penetrating the epidermal layer of a patient and accessing the vasculature of the patient. The needle hub 102 can have a needle guard extension 125 extending from the nose section 102a into the open chamber 120b of the interior cavity 120 for aligning the needle guard 122 during assembly, the details of which are further described below.

[0391] The proximal end 130 of the catheter hub 106 can have a female Luer taper with external threads 132, also known as a threaded female Luer connector. The female Luer connector is configured to matingly receive a male Luer connector, such as an IV line, a Luer access connector, a syringe tip, a vent plug, an IV set, an extension set, another known connector, or future-developed IV devices with a Luer tip. Each of these components can be sized and configured in conformity with at least some of the International Standards Organization (ISO) standards for female and male Luer connections under current or future standards. For discussion purposes, any one of these components or the class of these components can be referred to as a male medical implement or a male connector. As shown, the threaded female Luer connector receives a nose section 102a of the needle hub 102. A physical abutment is provided between the catheter hub 106 and the needle hub 102 so as to set the distance the needle tip extends out the distal end 107 of the catheter tube.

[0392] The catheter hub 106 can include a tab 131 on an exterior thereof configured for use as leverage when handling the device 100, such as to push against during insertion or removal of the needle 104. A pair of wings 109 may extend laterally of the catheter hub 106 to support and stabilize the catheter hub 106 against the patient following successful venipuncture. Optionally, the tab 131 and the wings 109 can be omitted.

[0393] A trigger or activator 140 can be incorporated for triggering the needle guard 122 to change its shape from an extended structural configuration to a coiled structural configuration to cover the needle tip 110 in a protective position, when the needle guard 122 is withdrawn proximally from the ready to use position after successful venipuncture. The trigger 140 can be unitarily formed with the catheter hub or separately formed and subsequently attached to the catheter hub. Explanations of both structural configurations of the needle guard 122 and the trigger 140 are further discussed below. In an example, when the needle guard 122 is in an extended structural configuration, such as that shown in FIGS. 1A and 3A, the distal ends of the two arms are spaced from the needle shaft so that no drag is exerted on the shaft by the flaps or arms 20, 30 of the needle guard 122 when the needle 104 moves relative to the needle guard, such as following placement of the catheter tube in a patient's vasculature. In other examples, no part of the two arms contacts the shaft in the extended structural configuration.

[0394] The activator 140 can be located in the interior cavity 120 by pressing a generally cylindrical outer surface 141 of the activator against the interior wall surfaces of the interior cavity 120, distal of the female Luer chamber of the catheter hub. The shape or contour of the outer surface 141 can match the surface of the interior cavity 120, such as being straight or taper. In one example, the outer surface 141 can include surface features (not shown) to align the activator 140 in a particular orientation inside the interior cavity 120. For example, a notch and a groove can be incorporated between the activator and the interior cavity to facilitate orienting the activator inside the catheter hub.

[0395] A projection 138, which can act as a stop, can be included inside the interior cavity 120 to prevent the activator 140 from displacing proximally out of position from a set position inside the interior cavity 120. The projection 138 can embody a continuous protrusion formed around a periphery or interior diameter of the interior cavity 120. In another example, the projection 138 can comprise a single bump or two or more spaced apart sections formed around a periphery of the interior cavity 120 instead of a continuous annular ring. The projection 138 can have two surfaces forming an apex wherein the two surfaces can include a blocking surface 137 and an inclined surface 139 proximal of the blocking surface 137. The inclined surface 139 elastically deforms the activator 140 as the activator 140 is pushed distally inside the interior cavity 120 over the inclined surface 139 and past the apex. Once the activator 140 has cleared the apex, the activator 140 can snap back into its original shape with the proximal end of the activator 140 contacting the blocking surface 137. The blocking surface 137 can prevent the activator 140 from moving proximally past the blocking surface 137 when the needle guard is retracted proximally during retraction of the needle following successful venipuncture. Alternatively, the activator 140 can be press fitted inside the interior cavity 120 thus eliminating the need for the projection 138. In other examples, the activator can be pressed fit inside the catheter hub and a projection 138 is also incorporated.

[0396] The activator 140 can be made from a number of materials, including from plastic or metal. The activator 140 can have a distal face 142 at a distal end, a proximal face 143 at a proximal end, and a bore 145 extending along a lengthwise axis of the activator through the distal face 142 and the proximal face 143. The distal face 142 can be flat or have a conical shape which tapers inwardly or outwardly. The proximal face 143 can also be flat or have a conical shape which tapers inwardly so as not to interfere with a male Luer taper inserted into the Luer chamber through the proximal opening 130. The shapes of the distal face 142 and proximal face 143 are not limited and can take on a variety of shapes to serve any purpose. In other examples, the activator 140 can be hollow and/or made from a resilient material that readily deforms when pushed into the bore of the catheter hub, such as from a polymer material.

[0397] FIG. 1B illustrates an end-view of the needle device 100 taken from line 1B-1B of FIG. 1A, with the needle 104 removed for clarity. The bore 145 of the activator 140 can be sized and shaped to activate or trigger the needle guard 122 from the extended configuration to the coiled configuration and to allow the needle guard 122 and the needle 104, including the needle tip 110, to pass through the bore 145 in the proximal direction when the needle guard 122 is in the protective position blocking the needle tip. When the needle guard changes from the extended configuration to the coiled configuration or when the needle guard changes from coiled configuration back to the extended configuration, the needle guard can be said to undergo a change in state or a phase change. This term is used differently than its normal meaning, which typically means a change between gas, liquid, and solid phases.

[0398] In one example, the needle guard 122 in the extended configuration cannot pass through the bore 145 of the activator without contacting the activator 140. As shown, the bore 145 can be rectangular in shape and have a length that tapers inwardly from the distal face 142 in the proximal direction. The interior surfaces of the bore 145 can be flat, concave, or convex. In other examples, the bore 145 can be generally cylindrical with a taper lip at the entrance. The bore 145 can be sized and shaped to activate the needle guard 122 and to allow the needle guard to pass from a distal position of the activator 140 to a proximal position of the activator, such as following successful venipuncture and as the needle 104 is retracted away from the catheter hub 106 with the needle guard 122 covering the needle tip 110.

[0399] Activating edges 146 formed between a surface of the bore 145 and the proximal face 143 of the activator can be configured to engage and trigger the needle guard 122 to change its configuration as the needle guard 122 is withdrawn proximally. The activating edges 146 can be flat, concave, or convex. The activating edges can be located along the same axial position of the activator 140 or along different axial positions of the activator 140 to contact and activate the needle guard at different time and/or different locations of the needle guard. In other examples, other surfaces and features of the bore 145 or activator 140 can be configured to change the configuration of the needle guard 122. For example, the needle guard 122 can contact a surface of the bore 145 other than the proximal activating edges 146 to change the configuration of the needle guard 122 from the extended structural configuration to the coiled structural configuration. Details of the interaction between the activator 140 and the needle guard 122 and how the needle guard changes its structural configuration are discussed below.

[0400] As shown in FIGS. 1A, 1B, and 3A, the needle guard 122 is positioned completely inside the interior cavity 120 of the catheter hub 106 in the ready position and during needle withdrawal prior to securing the needle tip 110 with the needle guard 122 in the protective position. In other examples, the needle guard 122 can be positioned partially inside the catheter hub body 106 or completely outside the catheter hub 106, such as in a shroud or a separate needle guard housing between the catheter hub 106 and the needle hub 102, so long as the needle guard 122 can be activated to a coiled position by the activator 140 to prevent exposure of the needle tip 110.

[0401] In an example, the needle guard 122 can comprise a proximal wall 126 and two flaps 20, 30, such as a first or top flap 20 and a second or bottom flap 30, extending distally of the proximal wall 126. The flaps 20, 30 can have the same width or different widths and the same length or different lengths. The flaps 20, 30 may alternatively be labeled or called arms. Optionally, a distal extension or extension 70 can extend from a distal end of the top flap 20 or on an end opposite the proximal wall 126. The extension 70 can also extend from the side flaps 40. The distal extension 70 can include one or more bent sections extending towards the needle 140 or remain parallel with the top flap 20. In another example, a second distal extension can extend from a distal end of each of the two flaps 20, 30 or from the side flaps of both the upper and lower arms. The flaps 20, 30 of the needle guard can be spaced from the interior wall surfaces of the interior cavity 120, the needle 104, and the activator 140 in the ready to use position. During needle retraction, the needle guard 122 can slide proximally and contact the activator 140 but not actuated by the activator 140 until after being pulled in the proximal direction by the change in profile on the needle 104 and into the activator 140. In other examples, during retraction, the needle guard 122 can be spaced from the activator 140 and not touch the activator 140 so that the needle 104 can move within the opening on the proximal wall 126 until the change in profile on the needle 104 engages the proximal wall 126. The length of the needle guard 122 can be greater than a distance between the change in profile 128 and the needle tip 110 to ensure capturing of the needle tip 110 in the needle guard 122 in the protective position.

[0402] The proximal wall 126 can comprise a perimeter defining a proximal opening 127 having the needle 104 passing therethrough. The perimeter of the proximal opening 127 is configured for engaging the change in profile 128 of the needle 104 following placement of the catheter tube 108 into a patient's vasculature. The change in profile 128 can be a crimp, a bulge, a sleeve, or a material buildup formed on the shaft of the needle 104 adjacent the needle tip 110 to prevent the needle guard 122 from displacing distally off of the needle 104 in the protective position.

[0403] In one example, the length of one of the flaps 20, 30 can be greater than the length of the other of the flaps 20, 30. The widths of the two flaps can be the same or different. Having different lengths can allow the two flaps 20, 30 to stagger when in the coiled configuration, as further discussed below. In another example, the length of the two flaps 20, 30 can be substantially the same. Each of the top flap 20 and the bottom flap 30 can have one or more sidewalls 40 extending from opposite sides of the top flap 20 and the bottom flap 30. The one or more sidewalls 40 can extend towards each other. The length, width, and shape of the sidewalls 40 can be uniform or can vary. The two flaps 20, 30, the proximal wall 126 and the sidewalls 40 of the needle guard 122 can define a needle tip holding space when the needle tip 110 is located therein, such as when the needle guard 122 is activated and covers the needle tip 110. The sidewalls 40 can prevent the needle 104 from moving sideways out of the sides of the needle guard 122 and out of the needle holding space.

[0404] The sidewalls 40 can increase the structural rigidity of the flaps 20, 30. Along a side of each flap 20, 30, a gap 45 can be provided between two adjacent sidewalls 40. The gap 45 can be trapezoidal (FIG. 1A), triangular (FIG. 3), rectangular, or other shapes that provide sufficient space or room for the sidewalls 40 to move when the flaps 20, 30 are activated, as further discussed below. Thus, the dimension and shape of each gap 45 is not limited to triangles and trapezoids or other shapes and can vary depending on the shape of the adjacent sidewalls 40 and the extent or amount of movement of the flaps 20, 30 following activation. At least one of the top flap 20 and the bottom flap 30 can have an arcuate surface along their respective widths. In other words, if each flap 20, 30 has a length along the lengthwise axis of the needle 104 and a wide orthogonal thereto, the side has an arcuate surface. In some examples, the entire width is formed along an arc or a curve. In some examples, the entire width of one or both flaps can be flat or not curved.

[0405] As shown, both the top flap 20 and the bottom flap 30 have an arcuate surface along the width. The arcuate surface of the top flap 20 and the bottom flap 30 can be concave or convex and can extend the entire length of the flap distal of the proximal wall 126. The wall surface of the flaps 20, 30 can have a substantially constant thickness and the arcuate surface can have a substantially constant radius of curvature or can have a complex curve. In other examples, the flaps 20, 30 can have a variable thickness and the radius of curvature of the arcuate surface can vary along the width. The arcuate surface of the flaps 20, 30 can force the flaps 20, 30 to extend distally in the extended structural configuration along a lengthwise direction. In other words, by maintaining an arc along the width for the length of the flap 20, 30, the arcuate surface can make the flaps 20, 30 stable in the extended configuration. The arc-shape structure provides reinforcement and stiffness that allow the flap to extend axially without breaking, collapsing, distorting, buckling or otherwise undergo a phase change until activated by a sufficient force, such as by an activator. The sidewalls 40 along the lengthwise direction of the flaps 20, 30 can stiffen the flaps 20, 30 by increasing the moment of inertia. The presence of the sidewalls 40 can prevent portions of the flaps 20, 30 from transitioning into the coiled configuration.

[0406] It has been found that when gaps 45 are provided in the sidewalls 40 along the lengthwise direction of each flap 20, 30, the structural rigidity of the flaps 20, 30 along the activating portions can be altered between the extended configuration and the coiled configuration. This information can be used to control or select the activating portions of the flaps 20, 30 to transition to a coiled configuration when triggered by the activator 140. In some examples, sections of the flaps 20, 30 are not rolled to not create a bi-stable situation. This can be incorporated so that sections of the flaps 20, 30, even without the side walls 40, can remain straight and not coil when activated. Thus, the location and shape of the sidewalls 40 and gaps 45 on the flaps 20, 30 can control the shape of the needle guard 122 in the coiled configuration and therefore how the flaps 20, 30 in the coiled configuration can cover the needle tip 110 in the protective position. Details of the mechanics of the flaps 20, 30 of the needle guard 122 morphing from an extended structural configuration to a coiled structural configuration are illustrated below with reference to an unfolded state of a needle guard, prior to folding the body into its final needle guard shape. The structure that can morph between one stable structural configuration or state to another stable structural configuration or state is known as a bistable structure or a structure with bistable phases.

[0407] Referring now to FIGS. 2A-2C, the needle guard 122 can be formed from a body 90 having an arcuate surface along a width or along a width section, as shown with notation W, which is generally orthogonal to the length. The body 90 can be stamped or cut in the unfolded state from a length of metal sheet or other material having an arcuate surface along the width. The body 90 and the various cut-out sections of the body 90 can be folded or manipulated to form various sections of the needle guard 122. In one example, the body 90 is generally rectangular having a length L, a width W extending orthogonally of the length, a substantially constant thickness T, and an arcuate surface along the width. The arcuate surface can have a substantially constant radius of curvature R along the width or can have a complex curve and the shape can extend along the lengthwise direction of the body.

[0408] The arcuate shaped width of the body 90 has a concave surface 91 and a convex surface 93. Depending on the direction the body 90 is coiled in the lengthwise direction to create the second bistable state, the concave surface 91 can be located to the outside or the convex surface 93 can be located to the outside when the body is activated into its coiled configuration, as further discussed below.

[0409] Although the shape of the body 90 is shown as being generally rectangular, the shape of the body 90 is not limited to the generally rectangular shape and in other examples the shape of the body 90 can have a regular or irregular polygonal shape or can comprise multiple pieces that can be attached or pieced together. In still other examples, the thickness T of the body 90 is not limited to a constant value and can vary. The radius of curvature R is also not limited to a constant value and can vary along the widthwise direction, such as having a complex curve.

[0410] A unique aspect of the body 90 is that one or more sections of the body can be a bistable structure, which means that the one or more sections of the body are capable of morphing between two stable structural configurations. It also means that at least a width section of a flap or both flaps can alternate from a first shape to a second shape and wherein the first shape is characterized by a curved surface and the second state is characterized by a surface that is less curved, such as being more flat or generally flat. As a point of reference, an example of a bistable structure is a slap bracelet, which is widely commercially available as kids' toys and reflectors for cyclists. The two stable configurations can be stabilized by different curvature axes. A first stable configuration of the two stable mechanical configurations can be the extended configuration and the second stable configuration can be the coiled configuration. In the extended configuration, the arcuate surface of the body 90 forces the body 90 in a straight extended configuration along the lengthwise direction, as discussed above. That is, the arcuate surface of the body 90 forces the body 90 to be stable in the extended configuration. An example of the extended configuration is shown in FIGS. 2A and 2B.

[0411] The body 90 can remain in the extended configuration until an external force is applied to the body 90, which then transitions the body 90 from the first stable configuration (extended configuration) to the second stable configuration (coiled configuration). For example, a force, such as an impulse force, can be applied to flatten or bend any part of the concave cross-section of the body 90 to change the body into its coiled configuration. To add, in the extended configuration, the width of the flap can have a bend or arc section. However, when activated to the coil configuration, the width flattens out, or at least has less of a curve, less of a bend, or less of an arc shape than when in the extended configuration, as the length of the body coils up to the second stable configuration. Once in transition, the body 90 can continue transitioning from the extended configuration to the coiled configuration without additional force because internal stresses in the body cause the body 90 to morph from the extended configuration into the coiled configuration. During the transition, the arcuate surface of the body 90 flattens thereby forcing the body 90 to curve or coil along an axis different than the axis of the arcuate surface. The coiling axis can be perpendicular to the arcuate surface axis.

[0412] Thus, an aspect of the present disclosure is understood include a needle device, comprising: a catheter hub having a body defining an interior cavity and having a proximal opening; a catheter tube extending distally of the catheter hub and comprising a distal opening; a needle hub; a needle extending distally of the needle hub and through said catheter hub and said catheter tube in a ready to use position, said needle comprising a shaft, a needle tip extending distally of the distal opening of the catheter tube, and a change in profile proximal of the needle tip; a needle guard comprising a proximal wall having a perimeter defining an opening having the needle passing therethrough, a first arm extending distally of the proximal wall and a second arm extending distally of the proximal wall opposite the first arm; and wherein the first arm and the second arm are spaced from the needle in the ready to use position and the needle guard is in a first configuration, and wherein the first arm and the second arm cover the needle tip in a protective position when the first arm and the second arm are activated and part of a width of the first arm, the second arm, or both change from a first shape to a second shape having less of a curved surface and the needle guard is in a second configuration. In some examples, the needle guard is used with a hub with an interior cavity that is not a catheter hub.

[0413] An example of the body 90 in the coiled configuration is shown in FIG. 2C. In the coiled configuration, the body 90 is coiled along the lengthwise direction. The coiled body can be uniform or non-uniform in which certain sections coil more than others or where some sections are not coiled at all. Thus, in a coil stated, the body may not be circular or round but can have a polygonal shape or an irregular rolled up shaped. The body 90 is also stable in this coiled configuration. Thus, the body 90 cannot transition back to the first stable configuration unless an external force is applied to uncoil the body 90 back into the extended configuration. Once the body 90 returns to the extended configuration from the coiled configuration, the body 90 remains stable in the extended configuration until a force is again applied to the body 90, which then transitions the body back to the coiled configuration. Thus, the body 90 can transition between these two stable configurations, phases, or states.

[0414] In one example, the coiled configuration may be coiled in a coiling direction against or away from the arcuate surface. For example, as shown in FIG. 2C, the body 90 can be coiled such that when activated from the extended configuration to the coiled configuration, the concave surface 91 can be located to the exterior or outside of the coiled shaped structure. In another example, the coiled configuration may be coiled in the opposite direction such that the convex surface 93 is now located to the exterior of the coiled shaped structure when the body 90 is activated from the extended configuration to the coiled configuration.

[0415] In both examples of coiling the body 90 to create a coiled structure with either the concave surface 91 located on the exterior or the convex surface 93 on the exterior, the arcuate surface of the body 90, such as the width of the body, can flatten thus maintaining a substantially flat cross-section in the coiled configuration. The substantially flat cross-section combined with the coiling of the body 90 along an axis different to the axis of the arcuate surface allows the body 90 to be stable in the coiled configuration. In some examples, the shape can be less curved or can have less or a bend without completely or substantially flattened out.

[0416] Although the extended configuration and coiled configuration are described for the unfolded state of the needle guard 122, the same principles apply when the unfolded body 90 is folded into a shape of a needle guard, such as the needle guard shown in FIGS. 1A and 3A. Thus, the flaps or other sections of the needle guard 122 can have bistable configurations that allow the needle guard, such as one or both flaps or sidewalls, to be arranged in a ready to use position inside a catheter hub and a folded or coiled configuration to cover the needle tip following successful venipuncture. Further, while an exemplary application of the needle guard having sections that have different stable configurations of the present disclosure has been disclosed with a needle assembly, such as one with a catheter hub and a catheter tube, the needle guard may be used with any number of needle devices, with or without a catheter tube, such as fistula needles.

[0417] Referring again to FIG. 2A, the various sections of the body 90 can be manipulated, such as bent or curved, to include the proximal wall 126, the bottom flap 30 extending distally of a first connecting side 80b of the proximal wall 126, the top flap 20 extending distally of a second connecting side 80c of the proximal wall 126 opposite the first side, the optional distal extension 70 extending from the top flap 20, and one or more sidewalls 40 extending from opposite sides of the flaps 20, 30 with gaps 45 provided adjacent to or between one or more sidewalls 40. The portions of the flaps 20, 30 coinciding with the gaps 45 can be defined as activating portions, as discussed further below. The width or spacing of each gap and the number of gaps can be selected depending on the shape of the coiled configuration of one or more flaps, as desired. In other examples, the distal extension 70 can extend from other sections of the needle guard, such as from the bottom flap or from the one or more sidewalls.

[0418] In some examples, sidewalls 40 can be incorporated to prevent the needle tip 110 from protruding out a side of the flaps 20, 30 and stiffen the flaps 20, 30 at portions of the flaps 20, 30 bordered by the sidewalls. The portions of the flaps 20, 30 bordered by the sidewalls 40 can be defined as non-activating portions.

[0419] As shown in FIG. 2A, the portion of the body representing the proximal wall 80 can be generally rectangular with the connecting sides 80b, 80c each extending along a widthwise direction and having an arcuate cross-section. Because the connecting sides 80b, 80c have arcuate cross-sections, cutouts 50 can be provided extending inward from opposite sides of the connecting sides 80b, 80c to ease bending along the connecting sides 80b, 80c. As shown, there are four cutouts 50 located between the proximal wall 80 and the two flaps 20, 30. The cutouts 50 can form along upper and lower edges of the proximal wall 80, near the two connecting sides 80b, 80c. Folding lines 60 can be provided on the body 90 to designate foldable or desired locations when forming the needle guard 122. In one example, the folding lines 60 can be etched or marked on the body 90.

[0420] The needle guard 122 can be formed by folding the body along the folding lines 60. In one example, the body 90 can be folded with the arcuate surfaces of the top flap 20 and the bottom flap 30 of the needle guard 122 opening outwardly in a direction away from the needle 104. In another example, the body 90 can be folded with the arcuate surfaces of the top flap 20 and the bottom flap 30 of the needle guard 122 opening in a direction towards the needle 104. For example, in FIG. 1B, the arcuate surfaces of the flaps 20, 30 are concave with the curve facing outwardly in a direction away from the needle 104. Alternatively, in other embodiments, only the flaps 20, 30 have arcuate surfaces, and not the proximal wall. The separately formed flaps can be separately attached, directly or indirectly, to the proximal wall 126, such as by welding.

[0421] The one or more sidewalls 40 can be bent towards each other along the folding lines 60. The sidewalls 40 and the gaps 45 along the flaps 20, 30 can be arranged and shaped to ensure that when activating portions of the flaps 20, 30, the sidewalls 40 do not interfere with each other and obstruct the flaps' ability to coil, as discussed further below. The sidewalls 40 may also be bent outwardly or bent multiple times. The distal extension 70, if present, can be bent towards the bottom flap 30 or remain parallel with the top flap 20. The distal extension 70 can be incorporated for securing or locking the top flap 20 to the bottom flap 30 and/or to obstruct the needle tip from re-emerging out the distal end of the needle guard following activation thereof. After the needle guard 122 is formed, the needle guard 122 can be assembled onto the needle device 100 along with the activator and prior to assembling the needle to the needle hub. In other examples, the needle guard can be mounted onto the needle after the needle is attached to the needle hub. For example, the crimp or change in profile can be formed after the needle guard is slidably placed onto the needle.

[0422] Turning now to FIGS. 3A and 3B, the needle 104 can be retracted proximally away from the catheter hub 106 following successful venipuncture by pulling on the needle hub 102 in the proximal direction. Because the opening 127 on the proximal wall 126 is larger than the diameter of the shaft of the needle 104, the needle 104 can be retracted proximally without dragging or pulling on the needle guard 122 proximally from a needle guard set position or from the catheter hub. As the flaps 20, 30 of the needle guard are spaced from the needle in the ready to use position, the needle 104 can also be retracted following successful venipuncture without the needle shaft or the change in profile 128 contacting the flaps 20, 30. Thus, the needle guard 122 or the flaps 20, 30 can remain in the extended configuration while the needle 104 retracts in the proximal direction until the change in profile 128 engages the perimeter of the opening 127 in the proximal wall 126.

[0423] Referring now to FIGS. 4A and 4B, with the change in profile 128 engaged against the perimeter defining the opening 127, further retraction of the needle 104 can pull the needle guard 122 proximally towards activating edges 146 of the activator 140. When the flaps 20, 30 of the needle guard 122 engage the activating edges 146 or other surface features of the activator 140 and further movement of the needle guard 122 in the proximal direction against the resistance of the activator 140 continues, the contact forces experienced by the flaps 20, 30 will cause the flaps to move inward towards the needle 104. The contact forces can also cause the bistable nature of the flaps to undergo a change.

[0424] The flaps 20, 30 can transition from the extended configuration, as shown in FIGS. 1A, 3A, and 3B, to the coiled configuration to cover the needle tip 110, as shown in FIGS. 4A and 4B, when activated. Said differently, when the needle guard 122 is triggered, the activating portions of the flaps 20, 30 coil inwardly to cover the needle tip 110 in the protective position. That is, the activating portions of the flaps 20, 30 transition into a relatively flat surface along their respective widths and coil towards the needle 104 to cover the needle tip 110. The portions of the flaps 20, 30 that do not undergo a change in state can remain in the extended configuration. For example, because of the increased rigidity from the sidewalls 40, because of no rolling to create bi-stable phases or both, portions of the flaps that border the sidewalls may not experience a phase change. That is, the sidewalls 40 prevent the portions of the flaps 20, 30 bordering the sidewalls from coiling.

[0425] In one embodiment, the sidewalls 40 and the gaps 45 along the flaps 20, 30 can be positioned and shaped to ensure that when portions of the flaps 20, 30 coil or undergo a phase change, the sidewalls 40 do not interfere with each other or interfere with the portions of the flaps that are intended to undergo a change. In other embodiments, the sidewalls 40 and the gaps 45 can be designed to engage each other to interlock the flaps 20, 30 together when the needle guard is in the coiled configuration to cover the needle tip 110 in the protective position.

[0426] The distal ends of the flaps 20, 30 can cooperatively cover the needle tip 110 in the protective position to prevent the needle tip 110 from re-emerging distally out the needle guard 122. If the top flap 20 is longer than the bottom flap 30, the bottom flap 30 can transition to the coiled configuration before the top flap 20 to ensure the top flap 20 covers the bottom flap 30 in the protective position. In other examples, the bottom flap is longer than the top flap and the reverse occurs.

[0427] The sequence of how the flaps transition or undergo a phase change can be controlled by selecting where to place the sidewalls 40, where the flaps contact the activator 140, the location and shape of the activator, the number of gaps, the size of the sidewalls, or combinations thereof.

[0428] The distal extension 70 at the distal end of the top flap 20 can engage with the bottom flap 30 to help secure the needle tip 110. In one example, the distal extension 70 can wrap below the bottom flap 30 to lock the needle guard 122 and secure the top flap 20 and bottom flap 30 together. In another example, an additional distal extension (not shown) can extend distally from the bottom flap 30. The additional distal extension can create additional friction between the two flaps 20, 30 to help secure the top flap 20 and bottom flap 30 together. Once the needle guard 122 covers the needle tip 110 in the protective position, the needle guard 122 can be pulled away from the activator 140 allowing the needle 104 to separate from the catheter hub 106 with the needle guard 122 covering the needle tip 110.

[0429] With reference now to FIG. 5, a fistula needle assembly 150 is shown for use in dialysis access and shown in a ready to use position. The present assembly comprises a first hub 152 and a second hub 154 removably engaged to one another in a ready to use position, which is a position in which the needle assembly 150 is ready for use on a patient. The second hub 154 has a needle 104 with a change in profile 128 proximal of a needle tip 110 extending therefrom. The first hub 152 comprises a body 156 defining an interior cavity 158 having a tip protector or needle guard 122 located therein. The second hub 154, which may also be referred to as a needle hub, has a body 160 defining an interior cavity 162 having a proximal opening having a vent plug 133 attached thereto. The interior cavity 162 may be referred as a blood flashback chamber and the vent plug 133 can include a vent filter 164 at a proximal end thereof for venting air or gas but not fluid, such as blood. A nose section 166 of the second hub 154 can extend into a proximal opening 168 of the first hub 152 to removably secure the two hubs 152, 154 together in the ready to use position. In other examples, the two hubs 152, 154 can removably engage one another in the ready to use position using other means, such as by gripping the external surface of the first hub 152 with a shroud on the second hub. A pair of wings 161 can extend laterally of the body 160 to provide points for securing the second hub 154 to the patient.

[0430] The tip protector 122 of the present embodiment may be similar to the tip protector discussed above with reference to FIGS. 1A-4B and has bistable configurations, phases, or states. In the present embodiment, the tip protector 122 is used with a needle 104 without an over-the-needle tube, such as a catheter tube. As shown, the tip protector 122 is located in the interior cavity 158 of the first hub 152, which has a proximal opening 166 and a distal opening 168. The interior cavity 158 defines a bore that is accessible through the proximal opening 168 and/or the distal opening 168. In other examples, the distal end of the first hub 152 can have a distal wall to partly close the distal opening 168 such that a smaller hole is provided as the distal opening that is sufficiently large for the needle 104 to pass therethrough but not the needle guard 122. The proximal opening 166 of the first hub 152 should be sufficiently large to allow the needle guard 122 to pass proximally thereof in a protective position to separate from the first hub 152, similar to the needle guard 122 of FIGS. 1A, 3A and 3B after activation and is removed from the proximal opening of the catheter hub.

[0431] Interiorly, the first hub 141 has a trigger or activator 140 for activating the needle guard 122, such as to change the state of the needle guard 122 from an extended state or first configuration to a coiled state or second configuration, as previously discussed. The trigger or activator 140 may be retained in the bore 158 by a projection 138. The activator 140 can be similar to the activator discussed elsewhere herein. In some examples, the first housing 152, and the activator 140 are unitarily formed, such as by plastic injection. In other examples, the activator 140 is separately formed and subsequently assembled to the first hub 152.

[0432] In use, the needle 104 is inserted to gain access to the patient's venous system. After use, the needle 104 is retracted away from the patient by pulling on the second hub 154 in the proximal direction while the first hub 152 is held so that the needle moves relative to the first hub and the needle guard 122. The needle 104 moves until the change in profile 128 abuts a perimeter defining an opening 127 on the proximal wall 126 of the needle guard, which is smaller in dimension that the largest width at the change in profile 128 so that a physical contact is made by the change in profile at the opening 127. The needle then pulls the needle guard 122 in the proximal direction against the activator 140, which causes the needle guard to change its state from a first or extended state to a second or coiled state to cover the needle tip 110, as discussed above. The needle guard 122 then separates from the first hub 152 with the needle 104. The first hub 152 and the protected needle 104 having the needle guard 122 covering the needle tip can be disposed of via standard protocol.

[0433] Alternatively, the needle can be removed from the patient before activating the needle guard 122. This can be performed by holding the needle hub or the second hub 154 steady while advancing the first hub 152 with the needle guard 122 located therein distally relative to the needle 104 towards the needle tip 110 so that the proximal wall 126 abuts the change in profile 128. Further movement at this point forces the activator 140 inside the first hub to contact and cause the needle guard 122 to change its state from a first or extended state to a second or coiled state to cover the needle tip 110, as discussed above. Alternatively or additionally, the second hub 154 can be retracted in the proximal direction while the first hub 152 is moved in the distal direction to activate the needle guard 122.

[0434] With reference now to FIG. 6A, a dialysis shunt 180 on an arm 182 with a venous needle assembly 150 and an arterial needle assembly 186 are shown. The two needle assemblies 150, 186 can be arranged in a conventional manner on an arm 182 for hemodialysis. The venous needle assembly 150 of the present embodiment can be the same as the fistula needle assembly 150 shown in FIG. 5. The arterial needle assembly 186 can be a conventional needle assembly for use in hemodialysis.

[0435] FIG. 6A shows an alternative mechanism and method for activating a needle guard 122 located inside a first hub 152 of the present disclosure. As shown, a tether 190 is connected to the first hub 152 to secure the first hub 152 while a user or practitioner retracts the needle 104 with a needle tip in the proximal direction relative to the first hub following dialysis. The user or practitioner can retract the needle 104 by gripping and moving the second hub 154 away from the first hub. This allows the change in profile 128 on the needle to be moved proximally against the proximal wall of the needle guard 122 and then pulling or moving the needle guard 122 proximally against the activator 140 to activate the needle guard, similar to the process discussed above with reference to FIG. 5 when the first hub is held steady by a user and the needle is retracted in the proximal direction relative to the first hub. The needle guard 122 of FIG. 6A therefore can change state from a first or extended state to a second or coiled state to cover the needle tip 110 by using a tether 190 to hold the first hub 152 steady and permit relative movement between the first hub 152 having the needle guard 122 located therein and the needle 104.

[0436] As shown in FIG. 6A, the tether 190 may have a first end connected to the first hub 152 and a second end 194 connected to an arterial needle assembly 186. The tether 190 may be made from any conventional prior art material, including from a fiber material, a plastic material, or a thin gauge wire. The ends 192, 194 of the tether 190 can be secured by adhesive, welding, knotting, or combinations thereof.

[0437] FIG. 6B shows a dialysis shunt 180 on an arm 182 with a venous needle assembly 150 and an arterial needle assembly 186, similar to the embodiment of FIG. 6A. In the present embodiment, one of the ends 194 of the tether 190 is connected to an anchor 200 instead of the arterial needle assembly 186. In an example, the anchor 200 can be a strap, an adhesive strip, or other securement means for holding the end 194 of the tether steady against the force of the retracting needle 104. As the needle 104 is retracted, the anchor 200 holds the tether thus preventing the first hub 152 from moving so that the needle 104 can move relative to the first hub to move the change in profile on the needle against the proximal wall of the needle guard, as discussed above. The needle guard 122 of FIG. 6B therefore can change state from a first or extended state to a second or coiled state to cover the needle tip 110 by using a tether 190 and an anchor 200 to hold the first hub 152 steady and permit relative movement between the first hub 152 having the needle guard therein and the needle 104.

[0438] FIG. 6C shows a dialysis shunt 180 on an arm 182 with a venous needle assembly 150 and an arterial needle assembly 186, similar to the embodiment of FIG. 6A. In the present embodiment, the first hub 152 is secured by an adhesive structure 204, such as a tape, a two-sided tape, an adhesive pad, or combinations thereof. As the needle 104 is retracted, the adhesive structure 204 holds the first hub 152 from moving so that the needle 104 can move relative to the first hub to move the change in profile on the needle against the proximal wall of the needle guard, as discussed above. The needle guard 122 of FIG. 6C therefore can change state from a first or extended state to a second or coiled state to cover the needle tip 110 by using an adhesive structure 204 to hold the first hub 152 steady and permit relative movement between the first hub 152 having the needle guard therein and the needle 104. In other examples, a strap or a band structure can be secured to a patient's arm and the strap or a band structure can have a receiving bay for receiving the first hub to secure the first hub and allowing relative movement between the first hub and the needle. The strap or band with the bay can wrap around the arm or can be secured to the arm with adhesive.

[0439] With reference now to FIG. 7A and 7B, a needle guard 122 having bistable configurations, phases, or states located inside a hub (not shown) and mounted on a needle 104 are shown in a pre-activated position and post-activated position, respectively. The needle guard 122 can be similar to the needle guards discussed elsewhere herein and can be located inside a hub having an activator, similar to the first hub 152 of FIGS. 5 and 6A-6C. The needle guard 122 can be activated to change state from a first or extended state, as shown in FIG. 7A, to a second or coiled state, as shown in FIG. 7B.

[0440] In the present embodiment, the first and second arms 20, 30 of the needle guard 122 are sized and shaped to coil into a gate 210 to close or block the bevel 212 at the needle tip 110 when the needle guard is activated by an activator. In an example, a gap 45 is created between each of two sets of sidewalls 40 on the first arm 20. Each of the gaps 45 can be axially located on the first arm so that when the first arm 20 is activated, a section of the first arm having a length is slanted to form the gate 210 for blocking the needle bevel 212. The length can be selected, such by selecting where to form the gaps 45, so that a bend 214 at or near the apex of the gap 45 extending to a tip 216 near the extension 70 is sufficiently long so as to extend across the entire bevel 212 of the needle. The sidewalls 40 on the second arm 30 can be provided with a distal mating edge 220. When the gate 210 rotates to cover the bevel, the gate can abut or contact the two distal mating edges 220 of the second arm 30.

[0441] In the present embodiment, the second arm 30 can be provided with a sidewall 40 extending from each of the two side edges of the second arm and each with a distal mating edge 220. The sidewalls 40 can be provided without any gap so as to form rigid sections to prevent the second arm from activating. In some examples, the sidewalls 40 of the second arm 30 can include one or more gaps formed at locations that will not affect the gate's ability to slant against the distal mating edges 220.

[0442] In an example, a sealing member 224 can be provided on the interior surface of the gate 210. The sealing member 224 can embody an elastic member, such as a soft rubber or silicone material. The sealing member 224 can be attached to the first arm by forming two or more tabs on the first arm that can be shaped or folded to grip the sealing member. For example, slits or cuts can be formed through the first arm that can then be folded to grab the sealing member. In other examples, adhesive or bonding can be used with or without the folded tabs to secure the sealing member 224 to the first arm. The sealing member 224 is sized and shaped and has a sufficient thickness to cover the needle bevel 212 as the gate 210 folds over the needle tip 110.

[0443] An extension 70 can be provided at a distal end of the first arm 20 for securing the gate 210 to the second arm 30 when the needle guard is activated to a protective position. Activation of the needle guard 122 can be carried out using one of several methods discussed elsewhere herein. The extension 70 can be straight, can have a hook, can include detents, can include an adhesive, or combinations thereof. The extension 70 on the first arm can be configured, such as sized and shaped, to secure against a second extension or a mating surface on the second arm.

[0444] In some examples, the needle guard 122 can include additional sealing members 224 located in the needle holding chamber of the needle guard, which is understood to include a space between the two arms and the sidewalls for accommodating the needle. The additional sealing members 224 can further assist with sealing a chamber around the needle tip and the needle bevel following activation of the needle guard over the needle tip.

[0445] In some examples, sensors can be added to the needle guard 122. For example, a strain gauge can be included to detect or sense activation of the needle guard. When the first arm, the second arm, or both bent or coil, the strain gauge can trigger a signal to notify that the needle guard has been activated. An open loop circuit can also be provided to sense when the first arm 20 and the second arm 30 contact one another, which closes the circuit when the two contact.

[0446] This will in turn trigger a signal to notify that the needle guard has been activated as the first arm now contacts the second arm to close the circuit.

[0447] Methods of making and of using the needle devices and components thereof shown and described elsewhere herein are within the scope of the present disclosure.

[0448] Although limited embodiments of the needle devices and their components have been specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. Furthermore, it is understood and contemplated that features specifically discussed for one needle device embodiment may be adopted for inclusion with another needle device embodiment, provided the functions are compatible. Accordingly, it is to be understood that the needle devices and their components constructed according to principles of the disclosed device, system, and method may be embodied other than as specifically described herein. The disclosure is also defined in the following claims.