Foldable insertion needle system for medical device access

Abstract

This document discloses an insertion needle system comprising: a body defining a bottom surface configured to engage a patient's skin surface; a needle bushing releasably coupled to the body, the needle bushing supporting a laterally extending needle; and a left wing and a right wing hingedly coupled to the needle bushing. The left wing may include a left main hinge and a left sub-hinge, the left main hinge being configured to pivot the left wing between a vertical and a horizontal position, and the left sub-hinge being configured to pivot a left outer leaflet relative to a left inner leaflet from an aligned position to a folded position. The right wing may include a right main hinge and a right sub-hinge, the right main hinge being configured to pivot the right wing between a vertical and a horizontal position, and the right sub-hinge being configured to pivot a right outer leaflet relative to a right inner leaflet from an aligned position to a folded position.

Description

[0001] priority

[0002] This application claims priority to International Application No. PCT / CN2024 / 070460, filed on January 3, 2024, the full text of which is incorporated herein by reference. Background Technology

[0003] Various needle insertion systems have been developed for medical devices that enter the patient's body, such as subcutaneous vascular access devices (VADs), ports, etc. These needle insertion systems typically include a needle extending along a transverse axis perpendicular to the skin surface, and a needle bushing supporting the needle and extending along a longitudinal axis. The needle defines a needle lumen, which is in fluid communication with a fluid line coupled to the needle bushing and configured to deliver a rapid bolus of fluids, medications, etc. The needle bushing facilitates manipulation and control of the needle during insertion.

[0004] In some existing needle insertion systems, the needle bushing is releasably coupled to a body defining a bottom surface. The body provides stability and support for the needle bushing, thereby ensuring proper alignment and control during insertion. However, these systems typically lack additional features that could enhance functionality and ease of use. One method for improving needle insertion systems involves incorporating wings on either side of the needle bushing. These wings can be designed to pivot between an vertical position that facilitates gripping of the needle bushing and body assembly and a horizontal position that provides additional support and stability once in place.

[0005] The wings can be angled downwards against the skin surface to stabilize the insertion needle assembly. However, in this position, the outer edge of the wing may press into the skin surface, causing irritation, trauma, or discomfort to the patient. Furthermore, the edge of the wing may slide against the skin surface, allowing the needle body to rotate, which can apply pressure to the needle, damage the insertion needle system, and cause internal trauma to the patient. Additionally, in the angled position, the wing may define a cavity between its lower surface and the skin surface. These cavities can trap sweat and promote the growth of bacteria and other pathogens, increasing the risk of infection at the insertion site.

[0006] To mitigate these issues, practitioners may pack these cavities with gauze to cushion the impact of the wings on the skin. However, this practice is not a recognized standard of care because the packing does not prevent the needle liner from rotating and may promote bacterial growth, thus increasing the risk of infection.

[0007] Therefore, there is a need for an entry needle system that provides wings of sufficient size for gripping and manipulating the system, while also being able to fold to alleviate the aforementioned problems. Summary of the Invention

[0008] In some aspects, the technology described herein relates to an access needle system for use in a medical device, comprising: a needle extending along a transverse axis perpendicular to the skin surface; a needle bushing supporting the needle and extending along a longitudinal axis; a body coupled to the needle bushing and defining a bottom surface; a left wing including a left main hinge and a left sub-hinge, the left main hinge being configured to pivot the left wing between a vertical and a horizontal position, the left sub-hinge being configured to pivot a left outer leaflet relative to a left inner leaflet from an aligned position to a folded position; and a right wing including a right main hinge and a right sub-hinge, the right main hinge being configured to pivot the right wing between a vertical and a horizontal position, the right sub-hinge being configured to pivot a right outer leaflet relative to a right inner leaflet from an aligned position to a folded position.

[0009] In some aspects, the technology described herein relates to an insertion needle system in which a left wing in a vertical position includes a left outer leaf and a left inner leaf aligned along a first axis, and a right wing in a vertical position includes a right outer leaf and a right inner leaf aligned along a second axis.

[0010] In some respects, the technology described herein relates to an insertion needle system in which a left wing in a vertical position extends perpendicular to the skin surface, and a right wing in a vertical position extends perpendicular to the skin surface.

[0011] In some aspects, the technology described herein relates to an entry needle system in which a left wing and a right wing in a vertical position include the outer edge of the left wing contacting the outer edge of the right wing and being positioned along a central vertical longitudinal plane.

[0012] In some aspects, the technology described herein relates to an insertion needle system in which the outer edge of the left wing releasably engages the outer edge of the right wing by means of a snap-fit, press-fit, interference fit, or protrusion-and-socket engagement.

[0013] In some aspects, the technology described herein relates to an entry needle system in which the left main hinge is configured to prevent the left wing from pivoting clockwise across the central vertical longitudinal plane, and the right main hinge is configured to prevent the right wing from pivoting counterclockwise across the central vertical longitudinal plane.

[0014] In some aspects, the technology described herein relates to an entry needle system in which the left sub-hinge is configured to allow the left outer leaf to pivot clockwise relative to the left inner leaf between an aligned position and a folded position, and wherein the right sub-hinge is configured to allow the right outer leaf to pivot counterclockwise relative to the right inner leaf between an aligned position and a folded position.

[0015] In some aspects, the technology described herein relates to an entry needle system in which a left sub-hinge is configured to prevent the left outer leaf from pivoting counterclockwise relative to the left inner leaf from an aligned position, and a right sub-hinge is configured to prevent the right outer leaf from pivoting clockwise relative to the right inner leaf from an aligned position.

[0016] In some aspects, the technology described herein relates to an entry needle system in which the left sub-hinge is configured to prevent the left outer leaf from rotating further clockwise by more than 90° relative to the left inner leaf, and in which the right sub-hinge is configured to prevent the right outer leaf from rotating further counterclockwise by more than 90° relative to the right inner leaf.

[0017] In some aspects, the technology described herein relates to an insertion needle system in which the left wing in the folded position includes a left inner leaflet vertically aligned with the left side wall of the body and a left outer leaflet parallel to the skin surface, and the right wing in the folded position includes a right inner leaflet vertically aligned with the right side wall of the body and a right outer leaflet parallel to the skin surface.

[0018] In some aspects, the technology described herein relates to an insertion needle system in which the surface of the left or right wing includes an overmolded elastomer disposed thereon.

[0019] In some aspects, the technology described herein relates to an access needle system in which a surface of the left lateral leaflet configured to engage a skin surface or a surface of the right lateral leaflet configured to engage a skin surface includes an elastomer molded thereon.

[0020] In some aspects, the technology described herein relates to an entry needle system in which the length (L) of the left inner leaf extending between the left main hinge and the left sub-hinge is greater than the distance (d) extending between the top surface and the bottom surface of the body, and in which the length (L) of the right inner leaf extending between the right main hinge and the right sub-hinge is greater than the distance (d) extending between the top surface and the bottom surface of the body.

[0021] In some aspects, the technology described herein relates to an insertion needle comprising: a body defining a bottom surface configured to engage a patient's skin surface; a needle bushing releasably coupled to the body, the needle bushing supporting a laterally extending needle; a left wing hingedly coupled to the needle bushing, the left wing including a left main hinge and a left sub-hinge, the left main hinge configured to pivot the left wing between a vertical and a horizontal position, the left sub-hinge configured to pivot a left outer leaflet relative to a left inner leaflet from an aligned position to a folded position; and a right wing hingedly coupled to the needle bushing, the right wing including a right main hinge and a right sub-hinge, the right main hinge configured to pivot the right wing between a vertical and a horizontal position, the right sub-hinge configured to pivot a right outer leaflet relative to a right inner leaflet from an aligned position to a folded position.

[0022] In some aspects, the technology described herein relates to a method of inserting a subcutaneous medical device, comprising: grasping a left wing and a right wing, the left and right wing being hingedly connected to a needle bushing and positioned in an upright position, a needle extending from the needle bushing along a transverse axis, the needle bushing being releasably connected to a body, the body defining a bottom surface and one or more side surfaces extending perpendicular to the bottom surface, the left wing being hingedly connected to the needle bushing via a left main hinge, and the right wing being hingedly connected to the needle bushing via a right main hinge; and laterally pushing the needle to penetrate. The skin surface is rotated until the bottom surface of the main body contacts the skin surface; the left and right wings are rotated from a vertical position to a horizontal position; the left wing is rotated from an aligned position to a folded position, in which the left outer leaf is angled relative to the left inner leaf of the left wing, and the left outer leaf is hinged to the left inner leaf via a left sub-hinged joint; and the right wing is rotated from an aligned position to a folded position, in which the right outer leaf is angled relative to the right inner leaf of the right wing, and the right outer leaf is hinged to the right inner leaf via a right sub-hinged joint.

[0023] In some aspects, the technology described herein relates to a method in which a left wing in a vertical position includes a left outer leaf and a left inner leaf aligned along a first axis, and a right wing in a vertical position includes a right outer leaf and a right inner leaf aligned along a second axis.

[0024] In some respects, the technique described herein relates to a method in which a left wing in a vertical position extends perpendicular to the skin surface, and a right wing in a vertical position extends perpendicular to the skin surface.

[0025] In some aspects, the technique described herein relates to a method in which a left wing and a right wing in a vertical position include the outer edge of the left wing contacting the outer edge of the right wing and being positioned along a central vertical longitudinal plane.

[0026] In some aspects, the technology described herein relates to a method that also includes releasably engaging the outer edges of the left wing and the outer edges of the right wing by means of snap-fit, press-fit, interference fit, or protrusion-and-receptor engagement.

[0027] In some aspects, the technology described herein relates to a method in which a left main hinge is configured to prevent the left wing from pivoting clockwise across the central vertical longitudinal plane, and a right main hinge is configured to prevent the right wing from pivoting counterclockwise across the central vertical longitudinal plane.

[0028] In some aspects, the technology described herein relates to a method in which a left wing in a folded position includes a left outer leaf angled relative to a left inner leaf, and a right wing in a folded position includes a right outer leaf angled relative to a right inner leaf.

[0029] In some aspects, the technology described herein relates to a method in which a left wing in a folded position includes a left outer leaf angled perpendicular to the left inner leaf, and a right wing in a folded position includes a right outer leaf angled perpendicular to the right inner leaf.

[0030] In some aspects, the technology described herein relates to a method in which a left sub-hinge is configured to maintain a left outer leaf at an angle of 90° or greater relative to a left inner leaf, and a right sub-hinge is configured to maintain a right outer leaf at an angle of 90° or greater relative to a right inner leaf.

[0031] In some aspects, the technology described herein relates to a method in which the left wing in the folded position includes a left inner leaf vertically aligned with the left side wall of the body and a left outer leaf parallel to the skin surface, and the right wing in the folded position includes a right inner leaf vertically aligned with the right side wall of the body and a right outer leaf parallel to the skin surface.

[0032] In some aspects, the technique described herein relates to a method in which the length (L) of the left inner leaf extending between the left main hinge and the left sub-hinge is greater than the distance (d) extending between the top surface and the bottom surface of the body, and in which the length (L) of the right inner leaf extending between the right main hinge and the right sub-hinge is greater than the distance (d) extending between the top surface and the bottom surface of the body.

[0033] In some aspects, the technology described herein relates to a method in which the surface of a left or right wing includes an overmolded elastomer disposed thereon.

[0034] In some aspects, the technology described herein relates to a method in which a surface of the left lateral leaflet configured to engage a skin surface or a surface of the right lateral leaflet configured to engage a skin surface includes an overmolded elastomer disposed thereon. Attached Figure Description

[0035] A more specific description of the disclosed text will be presented by reference to specific embodiments of the disclosed text illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit the scope of the invention. Exemplary embodiments of the invention will be described and explained with additional specificity and detail using the accompanying drawings, in which:

[0036] Figure 1 A perspective view of the needle insertion system in a vertical position according to the embodiment disclosed herein is shown.

[0037] Figure 2 A perspective view of the insertion needle system in a horizontal position according to the embodiment disclosed herein is shown.

[0038] Figure 3 A perspective view of the inlet needle system in the folded position according to the embodiment disclosed herein is shown.

[0039] Figures 4A to 4B A front view of the needle insertion system in a vertical position according to the embodiment disclosed herein is shown.

[0040] Figure 4C A front view of the needle insertion system in a horizontal position according to the embodiment disclosed herein is shown.

[0041] Figure 4D A front view of the inlet needle system in the folded position according to the embodiment disclosed herein is shown.

[0042] Figure 5A A front view of the insertion needle system in a first folded position, according to an embodiment disclosed herein, is shown.

[0043] Figure 5B A front view of the insertion needle system in the second folded position according to the embodiment disclosed herein is shown. Detailed Implementation

[0044] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may optionally be combined with or replace features of any of the many other embodiments disclosed herein. It should be understood that the accompanying drawings are schematic and illustrative representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0045] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and 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 set of features or steps and do not provide for a sequence or numerical limitation. For example, features or steps “first,” “second,” and “third” do not necessarily appear in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise. Furthermore, the words “comprising,” “having,” and “containing” as used herein (including the claims) shall have the same meaning as the word “comprising.”

[0046] In the following description, the terms “or” and “and / or” as used herein shall be interpreted as inclusive or referring to either or any combination thereof. For example, “A, B, or C” or “A, B, and / or C” means “any one of the following: A; B; C; A and B; A and C; B and C; A, B, and C”. Exceptions to this definition will only occur if a combination of elements, components, functions, steps, or actions is inherently mutually exclusive in some way.

[0047] In contrast to "proximal," for example, the "proximal portion" or "proximal portion" of a needle disclosed herein includes the portion of the needle intended to be placed near the clinician when the needle is used on a patient. Similarly, for example, the "proximal length" of a needle includes the length of the needle intended to be placed near the clinician when the needle is used on a patient. For example, the "proximal end" of a needle includes the end of the needle intended to be placed near the clinician when the needle is used on a patient. The proximal portion, proximal portion, or proximal length of a needle may include the proximal end of the needle; however, the proximal portion, proximal portion, or proximal length of a needle does not necessarily include the proximal end of the needle. That is, unless the context otherwise indicates, the proximal portion, proximal portion, or proximal length of a needle is not the distal portion or distal length of the needle.

[0048] In contrast to "distal," for example, the "distal portion" or "distal part" of a needle disclosed herein includes the portion of the needle intended to be placed near or inside the patient when the needle is used with the patient. Similarly, for example, the "distal length" of a needle includes the length of the needle intended to be placed near or inside the patient when the needle is used with the patient. For example, the "distal end" of a needle includes the end of the needle intended to be placed near or inside the patient when the needle is used with the patient. The distal portion, distal part, or distal length of a needle may include the distal end of the needle; however, the distal portion, distal part, or distal length of a needle does not necessarily include the distal end of the needle. That is, unless the context otherwise indicates, the distal portion, distal part, or distal length of a needle is not the distal portion or distal length of the needle.

[0049] To help describe the implementation scheme described in this article, such as Figure 1 As shown, the longitudinal axis extends substantially parallel to the axial length of the needle bushing. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes and is parallel to the axial length of the needle. The horizontal plane extends parallel to the skin surface and is defined by the longitudinal and lateral axes. The vertical plane extends perpendicular to the horizontal plane.

[0050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0051] Figure 1 An exemplary access needle system (“system”) 100 is illustrated, which typically includes a needle 102 supported by a needle bushing 104. The needle defines a needle lumen in fluid communication with a tubing 106, such as a medical line, fluid line, etc. System 100 is configured to access and provide fluid communication with a subcutaneous medical device, such as a subcutaneous vascular access device (VAD), port, or similar medical device. In one embodiment, needle 102 is a non-core needle, also known as a “Huber” needle. However, it should be understood that other types of needles or needle tip designs are also contemplated to fall within the scope of this invention.

[0052] In one 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 with a patient's skin surface 90. In one embodiment, the body 110 defines a recess configured to receive at least a portion of a needle liner 104 therein. The needle liner 104 is releasably engaged with the body 110 using one or more of press-fit, snap-fit, interference fit, and friction fit engagements.

[0053] As used herein, skin surface 90 defines a horizontal plane, wherein a vertical plane extends perpendicular to the horizontal plane. A tube 106 extends from needle bushing 104 along a longitudinal axis, wherein a lateral axis extends perpendicular to the longitudinal axis. A needle 102 extends from needle bushing 104 along a transverse axis. In one embodiment, a proximal portion of needle 102 extends from needle bushing along a longitudinal axis, and a distal portion of needle 102 extends at an angle relative to the proximal portion, for example, along a transverse axis. These and other configurations of access to needle 102 and needle bushing 104 are also contemplated to fall within the scope of the invention.

[0054] Continue to refer to Figure 1 The needle 102 extends from the needle bushing 104 along a transverse axis, passing through a hole in the bottom surface of the body 110 to slidably engage the body 110. In one embodiment, one or more arms are used to engage the needle bushing 104 with the body 110. The one or more arms are configured to allow the body 110 to slide relative to the needle bushing 104 and the needle 102, but to prevent the body 110 from disengaging from the needle 102. Thus, the body 110 can slide between the proximal and distal ends of the needle 102. When in the extended position, the one or more arms align and lock the body 110 with the distal end of the needle 102, thereby mitigating accidental needlestick injuries during removal of the system 100.

[0055] In one embodiment, the body 110 includes one or more stabilizing features (“stabilizers”), such as a first stabilizer 112A and a second stabilizer 112B. One or more stabilizing features may extend from the body 110 along a horizontal plane and may mitigate any rotation of the body 110 relative to the skin surface 90, which could cause patient discomfort or damage to the system 100. As shown, the first stabilizer 112A extends from the left side of the body 110, and the second stabilizer 112B extends from the right side of the body 110. However, it should be understood that other numbers and configurations of stabilizers are also contemplated.

[0056] In one embodiment, system 100 further includes a left wing 120 (or "first wing") and a right wing 130 (or "second wing"). In one embodiment, one or both of the left wing 120 and the right wing 130 are hingedly connected to one or both of the needle bushing 104 and the body 110. Figures 1 to 3 As shown, the left wing 120 and the right wing 130 are hingedly connected to the needle bushing 104. For example, the left wing 120 is connected to the needle bushing 104 via a left main hinge 122, and the right wing 130 is connected to the needle bushing 104 via a right main hinge 132. The axes of the left main hinge 122 and the right main hinge 132 extend along a longitudinal axis to allow the left wing 120 and the right wing 130 to rotate through a vertical lateral plane defined by a transverse axis and a lateral axis.

[0057] like Figure 1 and Figures 4A to 4B As shown, in one embodiment, the left main hinge 122 and the right main hinge 132 allow the corresponding left wing 120 and right wing 130 to rotate to a vertical position, parallel to the transverse axis, for example, Figure 4A In one embodiment, the left main hinge 122 and the right main hinge 132 allow the corresponding left wing 120 and right wing 130 to rotate through the transverse axis to a vertical position, in which the outer edge 124 of the left wing 120 contacts the outer edge 134 of the right wing 130, for example, Figure 4B The outer edge 124 of the left wing 120 is located at the end of the left wing 120 opposite to the left main hinge 122, and the outer edge 134 of the right wing 130 is located at the end of the right wing 130 opposite to the right main hinge 132. In one embodiment, the outer edge 124 of the left wing 120 may contact the outer edge 134 of the right wing 130 along the central longitudinal axis 70 of the body 110. Therefore, as Figure 1 As shown, in the vertical position, the left wing 120 and the right wing 130 can cooperate to provide a handle, which the user can use to grip and manipulate the needle bushing 104 or the entire system 100.

[0058] In one 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 prevents further rotation beyond the central longitudinal plane 70 to prevent the left wing 120 from crossing the right side of the central longitudinal plane 70. In one 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 prevents further rotation beyond the central longitudinal plane 70 to prevent the right wing 130 from crossing the left side of the central longitudinal plane 70. For example, the body 110 and / or the needle bushing 104 may include one or more abutments 140 configured to engage against one of the left wing 120 or the right wing 130 and prevent further rotation.

[0059] In one embodiment, the outer edge 124 of the left wing 120 may contact the outer edge 134 of the right wing 130 to prevent the left wing 120 from extending beyond the central longitudinal plane 70 and crossing the right side of the system 100, or to prevent the right wing 130 from extending beyond the central longitudinal plane 70 and crossing the left side of the system 100.

[0060] In one embodiment, system 100 includes a latch configured to releasably secure the left outer edge 124 and the right outer edge 134 in a vertical position. For example, as Figure 2 and Figure 3As shown, the right wing 130 includes a pawl 142 arranged near the right outer edge 134, and the left wing 120 includes a recess 144 arranged near the left outer edge 124. When the left wing 120 and the right wing 130 are in the vertical position ( Figure 1 The pawl 142 engages with the socket 144 in a press-fit, snap-fit, or interference fit, or releasably engages with it, to secure the left wing 120 to the right wing 130 along the central longitudinal plane 70 and / or prevent either the left wing 120 or the right wing 130 from further rotating through the central longitudinal plane 70.

[0061] It should be understood that a reverse latching configuration is also contemplated, in which the left wing 120 includes a pawl 142 and the right wing 130 includes a socket 144. It should be understood that other latching structures, or similar releasable locking mechanisms, such as hooks and loops (e.g., VELCRO), are also contemplated. ® ), adhesives, protrusions and locking components, etc.

[0062] like Figure 2 and Figure 4C As shown, in one 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 move from a vertical position ( Figure 1 Rotate to horizontal position ( Figure 2 and Figure 4C In the horizontal position, 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 in a leftward (counterclockwise) direction across the vertical lateral plane until the left wing 120 extends parallel to the skin surface 90. The right main hinge 132 is configured to allow the right wing 130 to rotate from the central longitudinal plane 70 in a rightward (clockwise) direction across the vertical lateral plane until the right wing 130 extends parallel to the skin surface 90.

[0063] In one 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. The axis of the left sub-hinge 126 is aligned with the longitudinal axis and parallel to the axis of the left main hinge 122. The left sub-hinge 126 allows the left outer leaf 152 to move relative to the left inner leaf 154 from an aligned position ( Figures 1 to 2 and Figures 4A to 4C Pivot to the folding position ( Figure 3 and Figure 4D In the aligned position, the left outer leaf 152 and the left inner leaf 154 are aligned along the same axis (e.g., the axis 72 of the left wing). In the folded position, the left outer leaf 152 and the left inner leaf 154 are at an angle relative to each other.

[0064] In one 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. The axis of the right sub-hinge 136 is aligned with the longitudinal axis and parallel to the axis of the right main hinge 132. The right sub-hinge 136 allows the right outer leaf 162 to move relative to the right inner leaf 164 from an aligned position ( Figures 1 to 2 and Figures 4A to 4C Pivot to the folding position ( Figure 3 and Figure 4D In the aligned position, the right outer leaf 162 and the right inner leaf 164 are aligned along the same axis (e.g., the right wing axis 74). In the folded position, the right outer leaf 162 and the right inner leaf 164 are at an angle relative to each other.

[0065] like Figure 4C As shown, in one embodiment, the left sub-hinge 126 is configured to allow the left outer leaf 152 to pivot clockwise from the aligned position, but prevents it from pivoting counterclockwise from the aligned position. In one embodiment, the right sub-hinge 136 is configured to allow the right outer leaf 162 to pivot counterclockwise from the aligned position, but prevents it from pivoting clockwise from the aligned position. Advantageously, when the left wing 120 is gripped in the vertical position, the left sub-hinge 126 prevents the left outer leaf 152 and the left inner leaf 154 from folding. Furthermore, when the right wing 130 is gripped in the vertical position, the right sub-hinge 136 prevents the right outer leaf 162 and the right inner leaf 164 from folding. In one embodiment, one or more of the left main hinge 122, right main hinge 132, left sub-hinge 126 and right sub-hinge 136 may be mechanical hinges, movable hinges or similar hinge mechanisms.

[0066] like Figure 3 and Figure 4D As shown, the left sub-hinge 126 allows the left wing 120 to fold, thereby allowing the left inner leaf 154 to be aligned parallel to one side of the body 110, and the left outer leaf 152 to be aligned parallel to the skin surface 90 (i.e., parallel to the left stabilizer 112A). Furthermore, the right sub-hinge 136 allows the right wing 130 to fold, thereby allowing the right inner leaf 164 to be aligned parallel to one side of the body 110, and the right outer leaf 162 to be aligned parallel to the skin surface 90 (i.e., parallel to the right stabilizer 112B).

[0067] In one embodiment, when the left outer leaf 152 reaches a 90° angle relative to the left inner leaf 154, the left sub-hinge 126 is configured to prevent further rotation, i.e., to prevent further rotation to an angle less than 90°. In other words, the left sub-hinge 126 is configured to allow the left outer leaf 152 to rotate between 90° (inclusive) and 180° (inclusive) relative to the left inner leaf 154. In one embodiment, when the right outer leaf 162 reaches a 90° angle relative to the right inner leaf 164, the right sub-hinge 136 is configured to prevent further rotation, i.e., to prevent further rotation to an angle less than 90°. In other words, the right sub-hinge 136 is configured to allow the right outer leaf 162 to rotate between 90° (inclusive) and 180° (inclusive) relative to the right inner leaf 164.

[0068] Advantageously, the system 100, including a left wing 120 with a left sub-hinge 126 and a right wing 130 with a right sub-hinge 136, allows the wings 120, 130 to fold flat against the body 110 and the skin surface 90. Alternatively, one or more of the left outer leaf 152, right outer leaf 162, left stabilizer 112A, and right stabilizer 112B can be attached downwards to the skin surface 90 with adhesive tape.

[0069] Advantageously, system 100 prevents the formation of cavities between the left wing 120 and the right wing 130 and the skin surface. For example, as Figure 4D As shown, system 100 is illustrated as having a left wing 120a and a right wing 130a in wireframe form, which do not include the corresponding left sub-hinge 126 and right sub-hinge 136. Therefore, wings 120a and 130a cannot be folded from their aligned positions. Wings 120a and 130a form cavities between wings 120a and 130a and the skin surface 90, thereby promoting the growth of bacteria, pathogens, etc.

[0070] In one embodiment, a portion of one or both of the molded left wing 120 and right wing 130 is covered with a soft elastomeric material. Exemplary elastomers include thermoplastic elastomers (TPEs) and the like. In one embodiment, the surface of one or both of the molded left lateral leaf 152 and right lateral leaf 162, i.e., a portion of the skin-contacting surface 90 of the left wing 120 or right wing 130, is covered with a soft elastomeric material. Advantageously, the soft elastomeric material can alleviate pressure ulcers and improve patient comfort.

[0071] In an exemplary method of use, an insertion needle system 100 as described herein is provided. System 100 includes a left wing 120 and a right wing 130 that rotate to a vertical position, as... Figure 4B As shown, the axis 72 of the left wing 120 and the axis 74 of the right wing 130 are aligned parallel to the transverse axis. In one embodiment, as... Figure 1 and Figure 4A As shown, one or more of the left wing 120 and the right wing 130 are rotated through the transverse axis, such that the left wing 120 and the right wing 130 are tilted toward the central longitudinal plane 70. In one embodiment, the outer edge 124 of the left wing 120 and the outer edge 134 of the right wing 130 contact each other at the central longitudinal vertical plane 70, preventing one or both of the left wing 120 or the right wing 130 from crossing to the opposite side.

[0072] In one embodiment, the left outer edge 124 is releasably secured to the right outer edge 134 by a press-fit, snap-fit, interference fit, latch, pawl and socket, or similar abutment or securing device, as described herein. Advantageously, the releasable securing between the left outer edge 124 and the right outer edge 134 reduces movement between them and prevents either the left wing 120 or the right wing 130 from rotating through the central vertical longitudinal plane 70. In one embodiment, the system 100 includes one or more abutments 140 configured to prevent further rotation of the wings 120, 130 through the central vertical longitudinal plane 70. Advantageously, when viewed from the front end, the wings 120, 130 support each other in a resilient triangular configuration in the vertical position and form a robust handle that facilitates gripping and manipulating the system 100.

[0073] The left wing 120 includes a left sub-hinge 126 that hinges the left outer leaf 152 to the left inner leaf 154. From an alignment position where the left outer leaf 152 and the left inner leaf 154 are aligned along the 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 is also configured to prevent counterclockwise rotation. Similarly, the right wing 130 includes a right sub-hinge 136 that hinges the right outer leaf 162 to the right inner leaf 164. From an alignment position where the right outer leaf 162 and the right inner leaf 164 are aligned along the axis 74 of the right wing 130, the right sub-hinge 136 is configured to allow the right outer leaf 162 to rotate counterclockwise relative to the right inner leaf 164, but is also configured to prevent clockwise rotation. Advantageously, as Figure 1 and Figure 4A As shown, the left sub-hinge 126 and the right sub-hinge 136 keep the wings 120 and 130 in an aligned position and prevent the wings 120 and 130 from collapsing at their respective midpoints when gripped in a vertical position, thereby maintaining a flexible triangular configuration.

[0074] like Figure 1 and Figure 4AAs shown, with wings 120 and 130 in the vertical position, a user can grasp wings 120 and 130 and push the end of needle 102 through the skin surface, for example, to enter a subcutaneous medical device, VAD, port, etc. Needle 102 can be inserted through the skin surface 90 until the bottom surface of the body 110 (and optionally, stabilizers 112A, 112B) engages with the skin surface 90.

[0075] like Figures 4A to 4C As shown, the user can then rotate wings 120 and 130 from a vertical position to a horizontal position. More specifically, the user can rotate the left wing 120 counterclockwise from the vertical position until the axis of the left wing 120 is horizontally aligned. Similarly, the user can rotate the right wing 130 clockwise from the vertical position until the axis of the right wing 130 is horizontally aligned. Figure 4C ).

[0076] like Figure 3 and Figure 4D As shown, the left sub-hinge 126 and the right sub-hinge 136 then allow the corresponding left wing 120 and right wing 130 to fold, thereby allowing the left inner leaf 154 and right inner leaf 164 to be vertically aligned with the side surface of the body 110. Furthermore, the left outer leaf 152 and right outer leaf 162 are horizontally aligned with the skin surface 90.

[0077] In one embodiment, the left sub-hinge 126 and the right sub-hinge 136 are configured to prevent rotation beyond a vertical angle. For example, the left sub-hinge 126 prevents the left outer leaf 152 from rotating more than 90° counterclockwise relative to the left inner leaf 154. Similarly, the right sub-hinge 136 prevents the right outer leaf 162 from rotating more than 90° clockwise relative to the right inner leaf 164. Advantageously, the left wing 120 and the right wing 130 in the folded position ( Figure 4D This allows the main body 110 to rest stably against the skin surface 90, thereby reducing the swaying or rotation of the main body 110 about the longitudinal axis, while the planar contact surface disperses the pressure on the skin surface 90, thereby reducing pressure sores, trauma, and discomfort for the patient. Advantageously, the wings 120, 130, in the vertical position, still provide sufficient surface for gripping and manipulating the system 100.

[0078] like Figure 4D As shown, the left wing 120a and right wing 130a do not include corresponding left or right sub-hinge members and cannot be moved from a horizontal position ( Figure 4C ) Convert to fold position ( Figure 4DIn the case of folding wings 120a and 130a, the wings may fold downwards toward the skin surface 90. The corresponding left and right outer edges may impact the skin surface, potentially causing abrasions, pressure sores, or similar trauma or discomfort to the patient. Furthermore, the cavity formed between the left wing 120a and right wing 130a in the unfolded position can trap sweat, promoting the growth of bacteria and other pathogens and increasing the risk of infection. Without the corresponding left and right sub-hinges 126 and 130a, the user may be forced to fill the space between the skin surface 90 and the wings 120a and 130a with gauze or similar padding to maintain the wings 120a and 130a in a horizontal position. Figure 4C This is done to prevent cavity formation and / or reduce trauma or discomfort to the patient. However, such practices are not recommended as standard of care because they prevent the wings 120a and 130a from stabilizing the body 110, thereby increasing the risk of damage to the needle 102.

[0079] Once processing is complete, the needle system 100 can be removed. Optionally, any tape used to stabilize the system 100 against the skin surface 90 can be removed. The left wing 120 and right wing 130 can be removed from the folded position ( Figure 4D Convert to horizontal position ( Figure 4C In the horizontal position, wings 120 and 130 are aligned along their respective axes. The left wing 120 and right wing 130 can be rotated from the horizontal position to the vertical position. Figure 4A The user can then use stabilizers 112A and 112B to stabilize the body 110 against the skin surface 90, and the gripping wings 120 and 130 can push the needle bushing 104 vertically upward. The needle bushing 104 can disengage from the body 110, allowing the needle 102 to slide relative to the body 110 and be withdrawn from the skin surface 90. Once the needle tip is positioned within the body 110, one or more arms of the needle bushing prevent further movement of the needle 102 relative to the body 110, thereby locking the needle tip within the body 110. The system 100 can then be safely disposed of.

[0080] like Figures 5A to 5B As shown, in one embodiment, system 100 includes a left inner leaflet 154 defining a length (L) between the left main hinge 122 and the left sub-hinge 126, which is greater than a distance (d) extending between the top and bottom of body 110. Similarly, a right inner leaflet 164 defines a length (L) between the right main hinge 132 and the right sub-hinge 136, which is greater than a distance (d) extending between the top and bottom of body 110. Advantageously, wings 120, 130 allow for variations in needle penetration depth between different patients.

[0081] For example, the depth of insertion into a medical device varies between patients and specific placement procedures. Differences in gender, age, and body composition may result in the medical device or port being placed at different depths, thus requiring needles of different lengths to penetrate and enter the device. Even when differences in gender, age, body composition, etc., are controlled, different placement procedures may still result in different placement depths, thus requiring different needle lengths. Even when such differences are controlled, the placement depth can vary by up to + / -3 mm; however, even greater or smaller placement depths are envisioned.

[0082] like Figures 5A to 5B As shown, the system 100, including the extended left medial lobe 154 and right medial lobe 164, can accommodate these differences in a single device. This provides a more versatile device, reduces the selection of incorrect devices requiring additional access attempts, and lowers the complexity and quantity of inventory that hospitals need to maintain. Figure 5A As shown, when the medical device is placed at a shallow depth and the needle 102 does not need to penetrate that deeply, the wings 120 and 130 support the body 110 and the needle bushing 104 in a relatively elevated position. The left inner leaflet 154 and the right inner leaflet 164 are substantially vertically aligned against the sidewall of the body 110, and the left outer leaflet 152 and the right outer leaflet 162 extend perpendicularly to their respective left inner leaflet 154 and right inner leaflet 164. The left outer leaflet 152 and the right outer leaflet 162 engage the skin surface 90 and support the system 100.

[0083] like Figure 5B As shown, when the medical device is placed at a deeper depth, the left inner lobe 154 and right inner lobe 164 rotate away from the body 110. The left outer lobe 152 and right outer lobe 162 pivot relative to the corresponding left inner lobe 154 and right inner lobe 164 and remain engaged with the skin surface 90. In this configuration, the body 110 and stabilizers 112A, 112B are allowed to extend toward and optionally engage with the skin surface 90. This allows the same system 100, having a needle 102 of the same length as in Figure 5A, to penetrate deeper and reach deeper than... Figure 5A Medical equipment is placed 90 degrees further away from the skin surface.

[0084] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will arise in those skilled in the art, and are also encompassed in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. An access needle system, comprising: The main body, which is defined by a bottom surface configured to engage with the patient's skin surface; A needle bushing, releasably coupled to the body, the needle bushing supporting a laterally extending needle; The left wing is hingedly connected to the needle bushing. The left wing includes a left main hinge and a left sub-hinge. The left main hinge is configured to pivot the left wing between a vertical position and a horizontal position. The left sub-hinge is configured to pivot the left outer leaf relative to the left inner leaf from an aligned position to a folded position. and The right wing is hingedly connected to the needle bushing. The right wing includes a right main hinge and a right sub-hinge. The right main hinge is configured to pivot the right wing between a vertical position and a horizontal position. The right sub-hinge is configured to pivot the right outer leaf relative to the right inner leaf from an aligned position to a folded position.

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

3. The insertion 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 needle insertion system according to claim 1, wherein the left wing and the right wing in the vertical position include the outer edge of the left wing, which contacts the outer edge of the right wing and is positioned along a central vertical longitudinal plane.

5. The insertion needle system according to claim 4, wherein the outer edge of the left wing releasably engages the outer edge of the right wing by means of a snap-fit, press-fit, interference fit, or protrusion-receiver engagement.

6. The insertion needle system of claim 1, wherein the left main hinge is configured to prevent the left wing from pivoting clockwise across the central vertical longitudinal plane, and the right main hinge is configured to prevent the right wing from pivoting counterclockwise across the central vertical longitudinal plane.

7. The insertion needle system of claim 1, wherein the left sub-hinge is configured to allow the left outer leaf to pivot clockwise relative to the left inner leaf between the aligned position and the folded position, and wherein the right sub-hinge is configured to allow the right outer leaf to pivot counterclockwise relative to the right inner leaf between the aligned position and the folded position.

8. The insertion needle system of claim 7, wherein the left sub-hinge is configured to prevent the left outer leaf from pivoting counterclockwise relative to the left inner leaf from the alignment position, and wherein the right sub-hinge is configured to prevent the right outer leaf from pivoting clockwise relative to the right inner leaf from the alignment position.

9. The insertion needle system of claim 7, wherein the left sub-hinge is configured to prevent the left outer leaf from rotating further clockwise by more than 90° relative to the left inner leaf, and wherein the right sub-hinge is configured to prevent the right outer leaf from rotating further counterclockwise by more than 90° relative to the right inner leaf.

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

11. The insertion needle system of claim 1, wherein the surface of the left wing or the right wing comprises an overmolded elastomer disposed thereon.

12. The insertion needle system of claim 11, wherein the surface of at least one of the left lateral leaflet and the right lateral leaflet configured to engage the skin surface comprises an elastomer molded thereon.

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

14. A method of inserting a subcutaneous medical device, comprising: The left and right wings are grasped, the left and right wings are hinged to the needle bushing and positioned in a vertical position, the needle extends from the needle bushing along a transverse axis, the needle bushing is releasably connected to the body, the body defines a bottom surface and one or more side surfaces extending perpendicular to the bottom surface, the left wing is hinged to the needle bushing via a left main hinge, and the right wing is hinged to the needle bushing via a right main hinge; The needle is pushed laterally to penetrate the skin surface until the bottom surface of the body contacts the skin surface; Rotate the left wing and the right wing from the vertical position to the horizontal position; The left wing is changed from the aligned position to the folded position. In the folded position, the left outer leaf of the left wing is at an angle relative to the left inner leaf. The left outer leaf is hinged to the left inner leaf via a left sub-hinged connector. as well as The right wing is changed from the aligned position to the folded position. In the folded position, the right outer leaf of the right wing is at an angle relative to the right inner leaf. The right outer leaf is hinged to the right inner leaf via a right sub-hinged connector.

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

16. The method of 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 of claim 14, wherein the left wing and the right wing in the vertical position include the outer edge of the left wing, which contacts the outer edge of the right wing and is positioned along a central vertical longitudinal plane.

18. The method of claim 17, further comprising releasably engaging the outer edge of the left wing and the outer edge of the right wing by means of a snap-fit, press-fit, interference fit, or protrusion-and-receptor engagement.

19. The method of claim 14, wherein the left main hinge is configured to prevent the left wing from pivoting clockwise across the central vertical longitudinal plane, and the right main hinge is configured to prevent the right wing from pivoting counterclockwise across the central vertical longitudinal plane.

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

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

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

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

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

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