Foldable access needle system for medical device access

Abstract

An access needle system includes a body defining a bottom surface configured to engage a skin surface of a patient, a needle hub releasably coupled to the body, the needle hub supporting a transversely extending needle, and a left and right wing hingedly coupled to the needle hub. The left wing can include a left main hinge configured to pivot the left wing between a vertical position and a horizontal position, and a left sub-hinge configured to pivot a left outer leaf relative to a left inner leaf from an aligned position to a folded position. The right wing can include a right main hinge configured to pivot the right wing between a vertical position and a horizontal position, and a right sub-hinge configured to pivot a right outer leaf relative to a right inner leaf from an aligned position to a folded position.

Description

FOLDABLE ACCESS NEEDLE SYSTEM FOR MEDICAL DEVICE ACCESSPRIORITY

[0001] This application claims the benefit of priority to International Application No. PCT / CN2024 / 070460, filed lanuary 3, 2024, which is incorporated in its entirety into this application.BACKGROUND

[0002] Various access needle systems have been developed for accessing medical devices within a patient’s body, for example subcutaneous vascular access devices (VAD), ports, or the like. These access needle systems typically include a needle that extends along a transverse axis, perpendicular to the skin surface, and a needle hub that supports the needle and extends along a longitudinal axis. The needle defines a needle lumen in fluid communication with a fluid line coupled to the needle hub and configured to delivering a bolus of fluid, medication, or the like. The needle hub facilitates manipulation and control of the needle during the insertion process.

[0003] In some existing access needle systems, the needle hub is releasably coupled to a body that defines a bottom surface. The body provides stability and support to the needle hub, ensuring proper alignment and control during the insertion process. However, these systems often lack additional features that could enhance the functionality and ease of use. One approach to improving access needle systems involves the incorporation of wings on either side of the needle hub. These wings can be designed to pivot between a vertical position, facilitating grasping the needle hub and body assembly, and a horizontal position, providing additional support and stability once placed.

[0004] The wings can be angled downwards into the skin surface to stabilize the access needle assembly. However, in such a position, the outer edges of the wings can press into the skin surface, causing irritation, trauma, or discomfort for the patient. Further, the edges of the wings can slip against the skin surface allowing the needle body to rotate, which can apply stress to the needle, damage to the access needle system and cause internal trauma to the patient. Further, in the angled position the wings can define cavities between the lower surface of the wing and the skin surface. These cavities can accumulate sweat and promote the growth of bacteria and other pathogens, increasing the risk of infection at the insertion site.

[0005] In order to mitigate the problems above, practitioners may wad the cavities with gauze to cushion the impact of the wings on the skin surface. However, such practices are not accepted standard of care since the waddings do not prevent rotation of the needle hub and may promote the growth of bacteria, increasing the risk of infection.

[0006] What is needed therefore is an access needle system that provides wings of sufficient size within which to grasp and manipulate the system, while being able to fold to mitigate the aforementioned problems.SUMMARY

[0007] In some aspects, the techniques described herein relate to an access needle system for accessing a medical device including, a needle extending along a transverse axis, perpendicular to a skin surface, a needle hub supporting the needle and extending along a longitudinal axis, a body coupled to the needle hub and defining a bottom surface, a left wing including a left main hinge configured to pivot the left wing between a vertical position and a horizontal position, and a left sub-hinge configured to pivot a left outer leaf relative to a left inner leaf from an aligned position to a folded position, and a right wing including a right main hinge configured to pivot the right wing between a vertical position and a horizontal position, and a right sub-hinge configured to pivot a right outer leaf relative to a right inner leaf from an aligned position to a folded position.

[0008] In some aspects, the techniques described herein relate to an access needle system, wherein the left wing in the vertical position includes the left outer leaf and the left inner leaf aligned along a first axis, and the right wing in the vertical position includes the right outer leaf and the right inner leaf aligned along a second axis.

[0009] In some aspects, the techniques described herein relate to an access needle system, wherein the left wing in the vertical position extends perpendicular to the skin surface, and the right wing in the vertical position extends perpendicular to the skin surface.

[0010] In some aspects, the techniques described herein relate to an access needle system, wherein the left wing and the right wing in the vertical position includes an outer edge of the left wing contacting an outer edge of the right wing and positioned along a central vertical longitudinal plane.

[0011] In some aspects, the techniques described herein relate to an access needle system, wherein the outer edge of the left wing releasably engages the outer edge of the right wing in a snap fit, press fit, interference fit engagement, or a protrusion and socket engagement.

[0012] In some aspects, the techniques described herein relate to an access needle system, wherein the left main hinge is configured to prevent the left wing from pivoting in a clockwise direction past a central vertical longitudinal plane, and the right main hinge is configured to prevent the right wing from pivoting in an anticlockwise direction past the central vertical longitudinal plane.

[0013] In some aspects, the techniques described herein relate to an access needle system, wherein the left sub-hinge is configured to allow the left outer leaf to pivot relative to the left inner leaf in a clockwise direction between the aligned position and the folded position, and wherein the right sub-hinge is configured to allow the right outer leaf to pivot relative to the right inner leaf in an anticlockwise direction between the aligned position and the folded position.

[0014] In some aspects, the techniques described herein relate to an access needle system, wherein the left sub-hinge is configured to prevent the left outer leaf from pivoting relative to the left inner leaf in the anticlockwise direction from the aligned position, and wherein the right sub-hinge is configured to prevent the right outer leaf from pivoting relative to the right inner leaf in the clockwise direction from the aligned position.

[0015] In some aspects, the techniques described herein relate to an access needle system, wherein the left sub-hinge is configured to prevent further rotation of the left outer leaf relative to the left inner leaf beyond a 90° angle in the clockwise direction, and wherein the right sub-hinge is configured to prevent further rotation of the right outer leaf relative to the right inner leaf beyond a 90° angle in the anticlockwise direction.

[0016] In some aspects, the techniques described herein relate to an access needle system, wherein the left wing in the folded position includes the left inner leaf aligned vertically with a left side wall of the body and the left outer leaf aligned parallel with a skin surface, and the right wing in the folded position includes the right inner leaf aligned vertically with a right side wall of the body and the right outer leaf aligned parallel with the skin surface.

[0017] In some aspects, the techniques described herein relate to an access needle system, wherein a surface of the left wing or the right wing includes an overmolded elastomer disposed thereon.

[0018] In some aspects, the techniques described herein relate to an access needle system, wherein a surface of the left outer leaf configured to engage the skin surface, or a surface of the right outer leaf configured to engage the skin surface includes an elastomer overmolded thereon.

[0019] In some aspects, the techniques described herein relate to an access needle system, wherein a length (L) of the left inner leaf, extending between the left main hinge and the left sub-hinge is greater than a distance (d) extending between a top surface of the body and a bottom surface of the body, and wherein a length (L) of the right inner leaf, extending between the right main hinge and the right sub-hinge is greater than a distance (d) extending between the top surface of the body and the bottom surface of the body.

[0020] In some aspects, the techniques described herein relate to an access needle including body defining a bottom surface configured to engage a skin surface of a patient, a needle hub releasably coupled to the body, the needle hub supporting a transversely extending needle, a left wing hingedly coupled to the needle hub, the left wing including a left main hinge configured to pivot the left wing between a vertical position and a horizontal position, and a left sub-hinge configured to pivot a left outer leaf relative to a left inner leaf from an aligned position to a folded position, and a right wing hingedly coupled to the needle hub, the right wing including a right main hinge configured to pivot the right wing between a vertical position and a horizontal position, and a right sub-hinge configured to pivot a right outer leaf relative to a right inner leaf from an aligned position to a folded position.

[0021] In some aspects, the techniques described herein relate to a method of accessing a subcutaneous medical device including, grasping a left wing and a right wing that are hingedly coupled to a needle hub and positioned in a vertical position, a needle extending from the needle hub along a transverse axis, the needle hub releasably coupled to a body defining a bottom surface and one or more side surfaces extending perpendicular thereto, the left wing hingedly coupled to the needle hub by a left main hinge, the right wing hingedly coupled to the needle hub by a right main hinge, urging the needle transversely to penetrate a skin surface until the bottom surface of the body contacts the skin surface, rotating the left wing and theright wing from the vertical position to a horizontal position, transitioning the left wing from an aligned position to a folded position where a left outer leaf is angled relative to a left inner leaf of the left wing, the left outer leaf hingedly coupled to the left inner leaf by a left subhinge, and transitioning the right wing from an aligned position to a folded position where a right outer leaf is angled relative to a right inner leaf of the right wing, the right outer leaf hingedly coupled to the right inner leaf by a right sub-hinge.

[0022] In some aspects, the techniques described herein relate to a method, wherein the left wing in the vertical position includes the left outer leaf and the left inner leaf aligned along a first axis, and the right wing in the vertical position includes the right outer leaf and the right inner leaf aligned along a second axis.

[0023] In some aspects, the techniques described herein relate to a method, wherein the left wing in the vertical position extends perpendicular to the skin surface, and the right wing in the vertical position extends perpendicular to the skin surface.

[0024] In some aspects, the techniques described herein relate to a method, wherein the left wing and the right wing in the vertical position includes an outer edge of the left wing contacting an outer edge of the right wing and positioned along a central vertical longitudinal plane.

[0025] In some aspects, the techniques described herein relate to a method, further including releasably engaging the outer edge of the left wing with the outer edge of the right wing in a snap-fit, press-fit, interference fit engagement, or a protrusion and socket engagement.

[0026] In some aspects, the techniques described herein relate to a method, wherein the left main hinge is configured to prevent the left wing from pivoting in a clockwise direction past a central vertical longitudinal plane, and the right main hinge is configured to prevent the right wing from pivoting in an anticlockwise direction past the central vertical longitudinal plane.

[0027] In some aspects, the techniques described herein relate to a method, wherein the left wing in the folded position includes the left outer leaf angled relative to the left inner leaf, and the right wing in the folded position includes the right outer leaf angled relative to the right inner leaf.

[0028] In some aspects, the techniques described herein relate to a method, wherein the left wing in the folded position includes the left outer leaf angled perpendicular to the left inner leaf, and the right wing in the folded position includes the right outer leaf angled perpendicular to the right inner leaf.

[0029] In some aspects, the techniques described herein relate to a method, wherein the left sub-hinge is configured to maintain the left outer leaf at an angle of 90° or greater relative to the left inner leaf, and the right sub-hinge is configured to maintain the right outer leaf at an angle of 90° or greater relative to the right inner leaf.

[0030] In some aspects, the techniques described herein relate to a method, wherein the left wing in the folded position includes the left inner leaf aligned vertically with a left side wall of the body and the left outer leaf aligned parallel with a skin surface, and the right wing in the folded position includes the right inner leaf aligned vertically with a right side wall of the body and the right outer leaf aligned parallel with the skin surface.

[0031] In some aspects, the techniques described herein relate to a method, wherein a length (L) of the left inner leaf, extending between the left main hinge and the left sub-hinge is greater than a distance (d) extending between a top surface of the body and a bottom surface of the body, and wherein a length (L) of the right inner leaf, extending between the right main hinge and the right sub-hinge is greater than a distance (d) extending between the top surface of the body and the bottom surface of the body. .

[0032] In some aspects, the techniques described herein relate to a method, wherein a surface of the left wing or the right wing includes an overmolded elastomer disposed thereon.

[0033] In some aspects, the techniques described herein relate to a method, wherein a surface of the left outer leaf configured to engage the skin surface, or a surface of the right outer leaf configured to engage the skin surface includes an overmolded elastomer disposed thereon.DRAWINGS

[0034] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0035] FIG. 1 shows a perspective view of an access needle system in a vertical position, in accordance with embodiments disclosed herein.

[0036] FIG. 2 shows a perspective view of an access needle system in a horizontal position, in accordance with embodiments disclosed herein.

[0037] FIG. 3 shows a perspective view of an access needle system in a folded position, in accordance with embodiments disclosed herein.

[0038] FIGS. 4A-4B show a front-end view of an access needle system in a vertical position, in accordance with embodiments disclosed herein.

[0039] FIG. 4C shows a front-end view of an access needle system in a horizontal position, in accordance with embodiments disclosed herein.

[0040] FIG. 4D shows a front-end view of an access needle system in a folded position, in accordance with embodiments disclosed herein.

[0041] FIG. 5A shows a front-end view of an access needle system in a first folded position, in accordance with embodiments disclosed herein.

[0042] FIG. 5B shows a front-end view of an access needle system in a second folded position, in accordance with embodiments disclosed herein.DESCRIPTION

[0043] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0044] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”

[0045] In the following description, the terms “or” and “and / or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and / or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.

[0046] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a needle disclosed herein includes a portion of the needle intended to be near a clinician when the needle is used on a patient. Likewise, a “proximal length” of, for example, the needle includes a length of the needle intended to be near the clinician when the needle is used on the patient. A “proximal end” of, for example, the needle includes an end of the needle intended to be near the clinician when the needle is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the needle can include the proximal end of the needle; however, the proximal portion, the proximal end portion, or the proximal length of the needle need not include the proximal end of the needle. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the needle is not a terminal portion or terminal length of the needle.

[0047] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a needle disclosed herein includes a portion of the needle intended to be near or in a patient when the needle is used on the patient. Likewise, a “distal length” of, for example, theneedle includes a length of the needle intended to be near or in the patient when the needle is used on the patient. A “distal end” of, for example, the needle includes an end of the needle intended to be near or in the patient when the needle is used on the patient. The distal portion, the distal end portion, or the distal length of the needle can include the distal end of the needle; however, the distal portion, the distal end portion, or the distal length of the needle need not include the distal end of the needle. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the needle is not a terminal portion or terminal length of the needle.

[0048] To assist in the description of embodiments described herein, as shown in FIG. 1, a longitudinal axis extends substantially parallel to an axial length of the needle hub. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes and parallel to an axial length of the needle. A horizontal plane extends parallel to a skin surface and is defined by the longitudinal and lateral axes. A vertical plane extends perpendicular to a horizontal plane.

[0049] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0050] FIG. 1 shows an exemplary access needle system (“system”) 100 generally including a needle 102 supported by a needle hub 104. The needle defines a needle lumen that is in fluid communication with a tubing 106, such as a medical line, fluid line, or the like. The system 100 is configured to access a subcutaneous medical device, such as a subcutaneous vascular access device (VAD), port, or similar medical device and provide fluid communication therewith. In an embodiment, the needle 102 is a non-coring, or “Huber” needle. However, it will be appreciated that other types of needles, or needle tip designs are contemplated to fall within the scope of the present invention.

[0051] In an embodiment, the needle is slidably engaged with a body 110. The body 110 includes a top surface, a bottom surface, and one or more side surfaces, or walls, extending therebetween. The bottom surface is configured to engage a skin surface 90 of a patient. In an embodiment, the body 110 defines a recess configured to receive at least a portion of the needle hub 104 therein. The needle hub 104 is releasably engaged with the body 110 using one or more of a press-fit, snap-fit, interference-fit, and friction-fit engagement.

[0052] As used herein, the skin surface 90 defines a horizontal plane with a vertical plane extending perpendicular thereto. The tubing 106 extends from the needle hub 104 along a longitudinal axis, with a lateral axis extending perpendicular thereto. The needle 102 extends from the needle hub 104 along a transverse axis. In an embodiment, a proximal portion of the needle 102 extends from the needle hub along a longitudinal axis and a distal portion of the needle 102 extends at an angle relative to the proximal portion, e.g., to extend along a transverse axis. These and other configurations of access needle 102 and needle hub 104 are contemplated to fall within the scope of the present invention.

[0053] With continued reference to FIG. 1, the needle 102 extends from the needle hub 104 along the transverse axis, through an aperture in a bottom surface of the body 110 to slidably engage the body 110. In an embodiment, the needle hub 104 is coupled with the body 110 using one or more arms. The one or more arms are configured to allow the body 110 to slide relative to the needle hub 104 and needle 102 but prevent the body 110 from disengaging the needle 102. As such the body 110 can slide between a proximal end and a distal tip of the needle 102. When in the extended position, the one or more arms align and lock the body 110 with a distal tip of the needle 102 mitigating accidental needle stick injuries once the system 100 is removed.

[0054] In an embodiment, the body 110 includes one or more stabilizing features (“stabilizers”), for example a first stabilizer 112A and a second stabilizer 112B. The one or more stabilizing features can extend from the body 110 along a horizontal plane and can mitigate any rotation of the body 110 relative to the skin surface 90 which might cause discomfort to the patient or damage to the system 100. As shown the first stabilizer 112A extends from a left side of the body 110 and a second stabilizer 112B extends from a right side of the body 110. However, it will be appreciated that other numbers and configurations of stabilizers are contemplated.

[0055] In an embodiment, the system 100 further includes a left wing 120, or “first wing,” and a right wing 130, or “second wing.” In an embodiment, one or both of the left wing 120 and the right wing 130 are hingedly coupled to one or both of the needle hub 104 and the body 110. As shown in FIGS. 1-3, the left wing 120 and the right wing 130 are hingedly coupled with the needle hub 104. For example, the left wing 120 is coupled to the needle hub 104 with a left main hinge 122 and the right wing 130 is coupled to the needle hub 104 with a right main hinge 132. An axis of the left main hinge 122 and an axis of the right main hinge132 extends along a longitudinal axis so as to allow the left wing 120 and the right wing 130 to rotate through a vertical lateral plane, defined by the transverse axis and the lateral axis.

[0056] As shown in FIGS. 1 and 4A-4B, in an embodiment, the left main hinge 122 and the right main hinge 132 allow the respective left wing 120 and right wing 130 to rotate to a vertical position, parallel to a transverse axis, e.g., FIG. 4A. In an embodiment, the left main hinge 122 and the right main hinge 132 allow the respective left wing 120 and right wing 130 to rotate past the transverse axis to a vertical position where the outer edge 124 of the left wing 120 contacts the outer edge 134 of the right wing 130, e.g., FIG. 4B. The outer edge 124 of the left wing 120 being disposed at an opposite end of the left wing 120 from the left main hinge 122, and the outer edge 134 of the right wing 130 being disposed at an opposite end of the right wing 130 from the right main hinge 132. In an embodiment, the outer edge 124 of the left wing 120 can contact the outer edge 134 of the right wing 130 along a central longitudinal axis 70 of the body 110. As such, as shown in FIG. 1, in the vertical position the left wing 120 and the right wing 130 can co-operate to provide a handle with which a user can grasp and manipulate the needle hub 104 or system 100 as a whole.

[0057] In an embodiment, the left main hinge 122 is configured to allow the left wing 120 to rotate through the vertical lateral plane up to the central longitudinal plane 70, but prevent further rotation beyond the central longitudinal plane 70 to prevent the left wing 120 from passing over to the right side of the central longitudinal plane 70. In an embodiment, the right main hinge 132 is configured to allow the right wing 130 to rotate through the vertical lateral plane up to the central longitudinal plane 70, but prevent further rotation beyond the central longitudinal plane 70 to prevent the right wing 130 from passing over to the left side of the central longitudinal plane 70. For example, the body 110 and / or needle hub 104 can include a one or more abutments 140 configured to engage against one of the left wing 120 or the right wing 130 and prevent further rotation.

[0058] In an embodiment, the outer edge 124 of the left wing 120 can contact the outer edge 134 of the right wing 130 to prevent either the left wing 120 from extending beyond the central longitudinal plane 70 over to the right side of the system 100, or prevent the right wing 130 from extending beyond the central longitudinal plane 70 to the left side of the system 100.

[0059] In an embodiment, the system 100 includes a latch configured to releasably secure the left outer edge 124 with the right outer edge 134 in the vertical position. Forexample, as shown in FIGS. 2 and 3, the right wing 130 includes a pawl 142 disposed adjacent the right outer edge 134 and the left wing 120 includes a socket 144 disposed adjacent the left outer edge 124. When the left wing 120 and the right wing 130 are in the vertical position (FIG. 1) the pawl 142 abuts against, or releasably engages, the socket 144 in a press-fit, snap fit, interference fit engagement to secure the left wing 120 to the right wing 130 along the central longitudinal plane 70 and / or prevent further rotation of either of the left wing 120 or the right wing 130 through the central longitudinal plane 70.

[0060] It will be appreciated that the opposite configuration of the latch is also contemplated where the left wing 120 includes the pawl 142 and the right wing 130 includes the socket 144. It will be appreciated that other configurations of latches, or similar releasable securement mechanisms such as hook-and-loop (e.g., VELCRO®), adhesive, protrusions and detents, or the like, are also contemplated.

[0061] As shown in FIGS. 2 and 4C, in an embodiment, one or both of the left main hinge 122 and the right main hinge 132 are configured to allow the respective left wing 120 and right wing 130 to rotate from the vertical position (FIG. 1) to a horizontal position (FIGS. 2 and 4C) where the left wing 120 and the right wing 130 extend parallel to the skin surface 90. For example, the left main hinge 122 is configured to allow the left wing 120 to rotate from the central longitudinal plane 70 through a vertical lateral plane in a leftwards direction (anticlockwise direction) until the left wing 120 extends parallel to a skin surface 90. The right main hinge 132 is configured to allow the right wing 130 to rotate from the central longitudinal plane 70 through a vertical lateral plane in a rightwards direction (clockwise direction) until the right wing 130 extends parallel to a skin surface 90.

[0062] In an embodiment, the left wing 120 further includes a left sub-hinge 126 disposed between the left main hinge 122 and the outer edge 124 of the left wing 120. An axis of the left sub-hinge 126 is aligned with the longitudinal axis, parallel with the axis of the left main hinge 122. The left sub-hinge 126 allows a left outer leaf 152 to pivot relative to the left inner leaf 154 from an aligned position (FIGS. 1-2, and 4A-4C) to a folded position (FIGS. 3 and 4D). In the aligned position the left outer leaf 152 and the left inner leaf 154 are aligned along the same axis, e.g., left wing axis 72. In the folded position, the left outer leaf 152 and the left inner leaf 154 are angled relative to each other.

[0063] In an embodiment, the right wing 130 further includes a right sub-hinge 136 disposed between the right main hinge 132 and the outer edge 134 of the right wing 130. An axis of the right sub-hinge 136 is aligned with the longitudinal axis, parallel with the axis of the right main hinge 132. The right sub-hinge 136 allows a right outer leaf 162 to pivot relative to the right inner leaf 164 from an aligned position (FIGS. 1-2 and 4A-4C) to a folded position (FIGS. 3 and 4D). In the aligned position the right outer leaf 162 and the right inner leaf 164 are aligned along the same axis, e.g., right wing axis 74. In the folded position, the right outer leaf 162 and the right inner leaf 164 are angled relative to each other.

[0064] As shown in FIG. 4C, in an embodiment, the left sub-hinge 126 is configured to allow the left outer leaf 152 to pivot from the aligned position in a clockwise direction, but prevent the left outer leaf 152 from pivoting from the aligned position in an anticlockwise direction. In an embodiment, the right sub-hinge 136 is configured to allow the right outer leaf 162 to pivot from the aligned position in an anticlockwise direction, but prevent the right outer leaf 162 from pivoting from the aligned position in a clockwise direction. Advantageously, the left sub-hinge 126 prevents the left outer leaf 152 and the left inner leaf 154 from folding when the left wing 120 is grasped in the vertical position. Further, the right sub-hinge 136 prevents the right outer leaf 162 and the right inner leaf 164 from folding when the right wing 130 is grasped in the vertical position. In an embodiment, one or more of the left main hinge 122, the right main hinge 132, the left sub-hinge 126, and the right sub-hinge 136 can be a mechanical hinge, a living hinge, or similar hinge mechanism.

[0065] As shown in FIGS. 3 and 4D, the left sub-hinge 126 allows the left wing 120 to fold, allowing the left inner leaf 154 to align parallel with a side of the body 110 and the left outer leaf 152 to align parallel with a skin surface 90, i.e., parallel with a left stabilizer 112A. Further, the right sub-hinge 136 allows the right wing 130 to fold, allowing the right inner leaf 164 to align parallel with a side of the body 110 and the right outer leaf 162 to align parallel with a skin surface 90, i.e., parallel with a right stabilizer 112B.

[0066] In an embodiment, when the left outer leaf 152 reaches an angle of 90° relative to the left inner leaf 154, the left sub-hinge 126 is configured to prevent further rotation, i.e., prevent further rotation to an angle of less than 90°. Worded differently, the left sub-hinge 126 is configured to allow rotation of the left outer leaf 152 relative to the left inner leaf 154 of between, or equal to, 90° and 180°. In an embodiment, when the right outer leaf 162 reaches an angle of 90° relative to the right inner leaf 164, the right sub-hinge 136 is configured toprevent further rotation, i.e., prevent further rotation to an angle of less than 90°. Worded differently, the right sub-hinge 136 is configured to allow rotation of the right outer leaf 162 relative to the right inner leaf 164 of between, or equal to, 90° and 180°.

[0067] Advantageously, the system 100 including the left wing 120 having the left subhinge 126 and the right wing 130 having the right sub-hinge 136 allows the wings 120, 130 to fold flat against the body 110 and the skin surface 90. Optionally, one or more of the left outer leaf 152, right outer leaf 162, left stabilizer 112 A, and the right stabilizer 112B can be taped down against the skin surface 90.

[0068] Advantageously, the system 100 prevents the formation of cavities between the left wing 120 and the right wing 130 and the skin surface. For example, as shown in FIG. 4D, the system 100 is shown with a left wing 120a and the right wing 130a in wire frame that do not include the respective left sub-hinge 126 and the right sub-hinge 136. As such, the wings 120a, 130a are not able to fold from the aligned position. The wings 120a, 130a form cavities between the wings 120a, 130a and the skin surface 90 promoting the growth of bacteria, pathogens, or the like.

[0069] In an embodiment, a portion of the one or both of the left wing 120 and the right wing 130 is overmolded with a soft elastomeric material. Exemplary elastomers include thermoplastic elastomer (TPE), or the like. In an embodiment, a surface of one or both of the left outer leaf 152 and the right outer leaf 162 is overmolded with a soft elastomeric material, i.e., the portion of the left wing 120 or the right wing 130 contacting the skin surface 90. Advantageously, the soft elastomeric material can mitigate pressure sores and improve patient comfort.

[0070] In an exemplary method of use, an access needle system 100 is provided as described herein. The system 100 includes a left wing 120 and a right wing 130 rotated to a vertical position where, as shown in FIG. 4B, an axis 72 of the left wing 120 and an axis 74 of the right wing 130 are aligned parallel with a transverse axis. In an embodiment, as shown in FIGS. 1 and 4A one or both of the left wing 120 and the right wing 130 are rotated past the transverse axis such that the left wing 120 and the right wing 130 are tilted towards a central longitudinal plane 70. In an embodiment, and outer edge 124 of the left wing 120 and an outer edge 134 of the right wing 130 contact each other at the central longitudinal vertical plane 70and prevent one or both of the left wing 120 or the right wing 130 from crossing to an opposite side.

[0071] In an embodiment, the left outer edge 124 is releasably secured to the right outer edge 134 with a press-fit, snap-fit, interference fit engagement, latches, pawl and socket, or similar abutment or securement means, as described herein. Advantageously, the releasable securement between the left outer edge 124 and the right outer edge 134 mitigates movement therebetween and prevents either of the left wing 120 or the right wing 130 from rotating past the central vertical longitudinal plane 70. In an embodiment, the system 100 includes one or more abutments 140 configured to inhibit further rotations of the wings 120, 130 past the central longitudinal vertical plane 70. Advantageously, the wings 120, 130 support each other in the vertical position in a resilient tri angle- shaped configuration when viewed from a front end, and create a robust handle that facilitates grasping and manipulating the system 100.

[0072] The left wing 120 includes a left sub-hinge 126 hingedly coupling a left outer leaf 152 to a left inner leaf 154. From the aligned position, where the left outer leaf 152 and the left inner leaf 154 are aligned along an axis 72 of the left wing 120, the left sub-hinge 126 is configured to allow the left outer leaf 152 to rotate clockwise relative to the left inner leaf 154 but also configured to prevent anti-clockwise rotation. Similarly, the right wing 130 includes a right sub-hinge 136 hingedly coupling a right outer leaf 162 to a right inner leaf 164. From the aligned position, where the right outer leaf 162 and the right inner leaf 164 are aligned along an axis 74 of the right wing 130, the right sub-hinge 136 is configured to allow the right outer leaf 162 to rotate anticlockwise relative to the right inner leaf 164 but also configured to prevent clockwise rotation. Advantageously, as shown in FIGS. 1 and 4A, the left sub-hinge 126 and the right sub-hinge 136 maintain the wings 120, 130 in an aligned position and prevent the wings 120, 130 from collapsing at the respective mid-points when grasped in the vertical position, maintaining the resilient triangular configuration.

[0073] As shown in FIGS. 1 and 4 A, with the wings 120, 130 in the vertical position, a user can grasp the wings 120, 130 and urge the tip of the needle 102 through a skin surface, for example, to access a subcutaneous medical device, VAD, port, or the like. The needle 102 can be inserted through the skin surface 90 until a bottom surface of the body 110, and optionally the stabilizers 112A, 112B engage a skin surface 90.

[0074] As shown in FIGS. 4A-4C, a user can then rotate the wings 120, 130 from the vertical position to a horizontal position. More specifically, the user can rotate a left wing 120 from the vertical position in an anticlockwise direction until an axis of the left wing 120 is aligned horizontally. Similarly, the user can rotate a right wing 130 from the vertical position in a clockwise direction until an axis of the right wing 130 is aligned horizontally. (FIG. 4C).

[0075] As shown in FIGS. 3 and 4D, the left sub-hinge 126 and right sub-hinge 136 then allow the respective left wing 120 and right wing 130 to fold, allowing the left inner leaf 154 and the right inner leaf 164 to align vertically with a side surface of the body 110. Further, the left outer leaf 152 and right outer leaf 162 aligns horizontally with a skin surface 90.

[0076] In an embodiment, the left sub-hinge 126 and right sub-hinge 136 are configured to prevent rotation beyond a perpendicular angle. For example, the left sub-hinge 126 prevents the left outer leaf 152 from rotating beyond a 90° angle relative to the left inner leaf 154 in an anticlockwise direction. Similarly, the right sub-hinge 136 prevents the right outer leaf 162 from rotating beyond a 90° angle relative to the right inner leaf 164 in a clockwise direction. Advantageously, the left wing 120 and the right wing 130, in the folded position (FIG. 4D) stabilizes the body 110 against the skin surface 90, mitigating rocking or rotation of the body 110 about a longitudinal axis, while the planar contact surface disperses pressure on the skin surface 90 mitigating pressure sores, trauma and discomfort to the patient. Advantageously, the wings 120, 130 in the vertical position still provide sufficient surface are with which to grasp and manipulate the system 100.

[0077] As shown in FIG. 4D, where the left wing 120a and right wing 130a do not include a respective left sub-hinge or right sub-hinge and is unable to transition from the horizontal position (FIG. 4C) to the folded position (FIG. 4D), the wings may fold downwards towards the skin surface 90. The respective left outer edge and right outer edge can impinge against a skin surface causing abrasions, pressure sores, or similar trauma or discomfort for the patient. Further, the cavities formed between the left wing 120a and right wing 130a in the unfolded position also accumulate sweat, promoting the growth of bacteria and other pathogens and increasing the risk of infection. Where wings 120a, 130a do not include respective left sub-hinge 126 and right sub-hinge 136 a user may be forced to pack the space between the skin surface 90 and the wings 120a, 130a with gauze or similar wadding to prevent cavities from forming, and / or mitigating trauma or discomfort to the patient by maintaining the wings 120a, 130a in the horizontal position (FIG. 4C). However, such a practice is not a recommendedstandard of care since it prevents the wings 120a, 130a from stabilizing body 110, increasing the risk of damage to the needle 102.

[0078] Once the treatment has been completed, the access needle system 100 can be removed. Optionally, any tape used to stabilize the system 100 with the skin surface 90 can be removed. The left wing 120 and the right wing 130 can be transitioned from the folded position (FIG. 4D) to the horizontal position (FIG. 4C) where the wings 120, 130 are aligned along respective axes. The left wing 120 and the right wing 130 can be rotated from the horizontal position to the vertical position (FIG. 4A). A user can then stabilize the body 110 against the skin surface 90 using the stabilizers 112 A, 112B and grasping the wings 120, 130 can urge the needle hub 104 vertically upwards. The needle hub 104 can disengage the body 110 allowing the needle 102 to slide with respect to the body 110, withdrawing the needle 102 from the skin surface 90. Once the needle tip is disposed within the body 110, one or more arms of the needle hub prevent further movement of the needle 102 with respect to the body 110 locking the needle tip within the body 110. The system 100 can then be disposed of safely.

[0079] As shown in FIGS. 5A-5B, in an embodiment, the system 100 includes a left inner leaf 154 as defining a length (Z) between a left main hinge 122 and a left sub-hinge 126 that is greater than a distance (d) that extends between the top of the body 110 and the bottom of the body 110. Similarly, a right inner leaf 164 defines a length (Z) between a right main hinge 132 and a right sub-hinge 136 that is greater than a distance (d) that extends between the top of the body 110 and the bottom of the body 110. Advantageously, the wings 120, 130 allow for variation in needle penetration depth between different patients.

[0080] For example, the depth of the medical device being accessed varies between individual patients and specific placements procedures. Differences in gender, age, and body compositions can results in the medical device, or port, being placed at different depths requiring different length needles to penetrate and access the medical device. Even when controlling for the differences in gender, age, body composition, etc., different placement procedures can still result in different placement depths, requiring different needle lengths. Even when controlling for such differences, placement depths can vary up to + / - 3mm, however, greater or lesser placement depths are also contemplated.

[0081] As shown in FIGS. 5A-5B, the system 100, including the extended inner left leaf 154 and the inner right leaf 164 can accommodate these differences in a single device.This provides a more versatile device, mitigates the selection of an incorrect device requiring additional access attempts and reduces the complexity and amount of inventory hospitals are required to carry. As shown in FIG. 5A, where a medical device is placed at a more shallow depth, and the needle 102 does not need to penetrate as deep, the wings 120, 130, support the body 110 and needle hub 104, at a relatively elevated position. The left inner leaf 154 and the right inner leaf 164 are aligned substantially vertically, against a side wall of the body 110, and the left outer leaf 152 and right outer leaf 162 extend perpendicular to the respective left inner leaf 154 and the right inner leaf 164. The left outer leaf 152 and right outer leaf 162 engage a skin surface 90 and support the system 100.

[0082] As shown in FIG. 5B, where a medical device is placed at a deeper depth, the left inner leaf 154 and the right inner leaf 164 rotate away from the body 110. The left outer leaf 152 and right outer leaf 162 pivot relative to the respective left inner leaf 154 and the right inner leaf 164 and remain engaged with the skin surface 90. In such a configuration, the body 110 and stabilizers 112 A, 112B are allowed extend towards the skin surface 90 and, optionally, engage the skin surface 90. This allows the same system 100, having the same length needle 102 as that of FIG. 5 A, to penetrate deeper and access a medical device disposed further from the skin surface 90 than that of FIG. 5 A.

[0083] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. An access needle system, comprising: a body defining a bottom surface configured to engage a skin surface of a patient; a needle hub releasably coupled to the body, the needle hub supporting a transversely extending needle; a left wing hingedly coupled to the needle hub, the left wing including a left main hinge configured to pivot the left wing between a vertical position and a horizontal position, and a left sub-hinge configured to pivot a left outer leaf relative to a left inner leaf from an aligned position to a folded position; and a right wing hingedly coupled to the needle hub, the right wing including a right main hinge configured to pivot the right wing between a vertical position and a horizontal position, and a right sub-hinge configured to pivot a right outer leaf relative to a right inner leaf from an aligned position to a folded position.

2. The access needle system according to claim 1, wherein the left wing in the vertical position includes the left outer leaf and the left inner leaf aligned along a first axis, and the right wing in the vertical position includes the right outer leaf and the right inner leaf aligned along a second axis.

3. The access needle system according to claim 1, wherein the left wing in the vertical position extends perpendicular to the bottom surface of the body, and the right wing in the vertical position extends perpendicular to the bottom surface of the body.

4. The access needle system according to claim 1, wherein the left wing and the right wing in the vertical position includes an outer edge of the left wing contacting an outer edge of the right wing and positioned along a central vertical longitudinal plane.

5. The access needle system according to claim 4, wherein the outer edge of the left wing releasably engages the outer edge of the right wing in a snap fit, press fit, interference fit engagement, or a protrusion and socket engagement.

6. The access needle system according to claim 1, wherein the left main hinge is configured to prevent the left wing from pivoting in a clockwise direction past a central vertical longitudinal plane, and the right main hinge is configured to prevent the right wing from pivoting in an anticlockwise direction past the central vertical longitudinal plane.

7. The access needle system according to claim 1, wherein the left sub-hinge is configured to allow the left outer leaf to pivot relative to the left inner leaf in a clockwise direction between the aligned position and the folded position, and wherein the right sub-hinge is configured to allow the right outer leaf to pivot relative to the right inner leaf in an anticlockwise direction between the aligned position and the folded position.

8. The access needle system according to claim 7, wherein the left sub-hinge is configured to prevent the left outer leaf from pivoting relative to the left inner leaf in the anticlockwise direction from the aligned position, and wherein the right sub-hinge is configured to prevent the right outer leaf from pivoting relative to the right inner leaf in the clockwise direction from the aligned position.

9. The access needle system according to claim 7, wherein the left sub-hinge is configured to prevent further rotation of the left outer leaf relative to the left inner leaf beyond a 90° angle in the clockwise direction, and wherein the right sub-hinge is configured to prevent further rotation of the right outer leaf relative to the right inner leaf beyond a 90° angle in the anticlockwise direction.

10. The access needle system according to claim 1, wherein the left wing in the folded position includes the left inner leaf aligned vertically with a left side wall of the body and the left outer leaf aligned parallel with the bottom surface of the body, and the right wing in the folded position includes the right inner leaf aligned vertically with a right side wall of the body and the right outer leaf aligned parallel with the bottom surface of the body.

11. The access needle system according to claim 1, wherein a surface of the left wing or the right wing includes an overmolded elastomer disposed thereon.

12. The access needle system according to claim 11, wherein a surface configured to engage the skin surface of at least one of the left outer leaf and the right outer leaf includes an elastomer overmolded thereon.

13. The access needle system according to claim 1, wherein a length ( / .) of the left inner leaf, extending between the left main hinge and the left sub-hinge is greater than a distance (d) extending between a top surface of the body and a bottom surface of the body, and wherein a length ( / .) of the right inner leaf, extending between the right main hinge and the right sub-hinge is greater than a distance (d) extending between the top surface of the body and the bottom surface of the body.

14. A method of accessing a subcutaneous medical device, comprising: grasping a left wing and a right wing that are hingedly coupled to a needle hub and positioned in a vertical position, a needle extending from the needle hub along a transverse axis, the needle hub releasably coupled to a body defining a bottom surface and one or more side surfaces extending perpendicular thereto, the left wing hingedly coupled to the needle hub by a left main hinge, the right wing hingedly coupled to the needle hub by a right main hinge; urging the needle transversely to penetrate a skin surface until the bottom surface of the body contacts the skin surface; rotating the left wing and the right wing from the vertical position to a horizontal position; transitioning the left wing from an aligned position to a folded position where a left outer leaf is angled relative to a left inner leaf of the left wing, the left outer leaf hingedly coupled to the left inner leaf by a left sub-hinge; and transitioning the right wing from an aligned position to a folded position where a right outer leaf is angled relative to a right inner leaf of the right wing, the right outer leaf hingedly coupled to the right inner leaf by a right sub-hinge.

15. The method according to claim 14, wherein the left wing in the vertical position includes the left outer leaf and the left inner leaf aligned along a first axis, and the right wing in the vertical position includes the right outer leaf and the right inner leaf aligned along a second axis.

16. The method according to claim 14, wherein the left wing in the vertical position extends perpendicular to the skin surface, and the right wing in the vertical position extends perpendicular to the skin surface.

17. The method according to claim 14, wherein the left wing and the right wing in the vertical position includes an outer edge of the left wing contacting an outer edge of the right wing and positioned along a central vertical longitudinal plane.

18. The method according to claim 17, further including releasably engaging the outer edge of the left wing with the outer edge of the right wing in a snap-fit, press-fit, interference fit engagement, or a protrusion and socket engagement.

19. The method according to claim 14, wherein the left main hinge is configured to prevent the left wing from pivoting in a clockwise direction past a central vertical longitudinal plane, and the right main hinge is configured to prevent the right wing from pivoting in an anticlockwise direction past the central vertical longitudinal plane.

20. The method according to claim 14, wherein the left wing in the folded position includes the left outer leaf angled relative to the left inner leaf, and the right wing in the folded position includes the right outer leaf angled relative to the right inner leaf.

21. The method according to claim 20, wherein the left wing in the folded position includes the left outer leaf angled perpendicular to the left inner leaf, and the right wing in the folded position includes the right outer leaf angled perpendicular to the right inner leaf.

22. The method according to claim 20, wherein the left sub-hinge is configured to maintain the left outer leaf at an angle of 90° or greater relative to the left inner leaf, and the right sub-hinge is configured to maintain the right outer leaf at an angle of 90° or greater relative to the right inner leaf.

23. The method according to claim 14, wherein the left wing in the folded position includes the left inner leaf aligned vertically with a left side wall of the body and the left outer leaf aligned parallel with a skin surface, and the right wing in the folded position includes the right inner leaf aligned vertically with a right side wall of the body and the right outer leaf aligned parallel with the skin surface.

24. The method according to claim 14, wherein a length (Z) of the left inner leaf, extending between the left main hinge and the left sub-hinge is greater than a distance (d) extending between a top surface of the body and a bottom surface of the body, and wherein a length (Z) of the right inner leaf, extending between the right main hinge and the right sub-hinge is greater than a distance (d) extending between the top surface of the body and the bottom surface of the body.

25. The method according to claim 14, wherein a surface of the left wing or the right wing includes an overmolded elastomer disposed thereon.

26. The method according to claim 14, wherein a surface of the left outer leaf configured to engage the skin surface, or a surface of the right outer leaf configured to engage the skin surface includes an overmolded elastomer disposed thereon.

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