Vascular access device with active needle length adjustment

Abstract

The present invention relates to a vascular access device that has a needle length adjustment function, in which the entire length of the needle penetrates the stopper vial and a desired needle length that is shorter than the entire length of the needle penetrates the patient's skin.

Description

[Technical Field]

[0001] The present disclosure relates to vascular access devices with adjustable needle length, and in particular, the present disclosure relates to an insulin syringe with needle length adjustment for penetrating both the insulin vial and the patient's skin. [Background technology]

[0002] Syringes are commonly used in the art to withdraw medication from vials and inject the medication into a patient's skin. Needle cannulae for syringes come in a variety of gauges and lengths depending on the application, the depth of insertion into the patient's skin, and other factors. Thicker needle gauges can be used when withdrawing medication from vials. Syringes can have an integrated, non-removable needle cannula fixed to the distal end of the barrel, or they can have a needleless connector that can be attached to a removable, replaceable needle hub.

[0003] Common insulin syringes in the art have a standard needle cannula length of 6 mm. The needle cannula of an insulin syringe can be permanently attached to the syringe or can be attached to the insulin syringe's needleless connector via a needle hub. A 6 mm needle cannula is used because it can penetrate the stopper of a standard insulin vial at any angle and reach the insulin in the vial for insulin aspiration.

[0004] Insulin is commonly injected into the subcutaneous layer beneath the skin to ensure rapid and uniform distribution of insulin throughout the patient's body. A 6-mm needle cannula can penetrate the subcutaneous layer and enter the underlying muscle layer, which is undesirable. To prevent this from occurring, practitioners administering insulin shots typically must clamp the area where the insulin shot / injection is to be administered to prevent the 6-mm needle cannula from penetrating the muscle layer. This method can be a tedious process that can lead to patient discomfort, needlestick injuries, and inconsistent results. Alternatively, an interchangeable needle hub can be used to first draw medication from a vial using a 6-mm needle cannula and then administer the medication using a shorter needle length. This alternative results in additional waste.

[0005] Therefore, there is a need to provide a disposable needle vascular access device that can properly withdraw medication from a vial and then administer the medication into the subcutaneous layer beneath the skin. Summary of the Invention

[0006] A first aspect of the present disclosure relates to a vascular access device having a cylindrical base, a tab, and a movable collar. The cylindrical base has a proximal end and a distal end. The proximal end of the cylindrical base has a proximal wall and an elongated tip extending from the proximal wall, the elongated tip having one or more longitudinal slots. The cylindrical base further has an outer cylindrical wall and an outer cavity between the outer cylindrical wall and the elongated tip, the outer cylindrical wall having a notch extending from the distal end to the proximal wall. The tab is connected to the distal end of the outer cylindrical wall with a living hinge connecting the tab to the outer cylindrical wall. The tab is configured to pivot about the living hinge. The tab covers the notch in the cylindrical base in the closed position. The tab further includes a crescent-shaped cam having a stem and a distal peak, the distal peak extending distally in the closed position. A movable collar disposed within the outer cavity has a proximal end and a distal end, the distal end including one or more snap locks configured to move within the one or more longitudinal slots, the movable collar further including a clearance cutout extending from the distal end a distance along the movable collar, the clearance cutout having a cam contact surface.

[0007] In some embodiments, the elongate tip includes a proximal portion and a distal portion, the distal portion having an outer surface, the elongate tip further includes an aperture extending therethrough, and one or more longitudinal slots extend on the proximal portion.

[0008] In some embodiments, the contact surface is formed between a proximal portion and a distal portion of the elongate tip, hi some embodiments, a sterile cap is inserted over the elongate tip and contacts the contact surface.

[0009] In some embodiments, the living hinge includes one or more longitudinal protrusions configured to create a snap fit with corresponding slots disposed in the proximal wall.

[0010] In some embodiments, the proximal wall has a cavity for receiving the distal end of a vascular access device.

[0011] In some embodiments, the movable collar includes a distal flange configured to abut a distal end of the outer cylindrical wall upon full advancement of the movable collar within the cylindrical base, hi some embodiments, the movable collar has an initial position, an aspiration position, and an infusion position.

[0012] In some embodiments, the needle cannula of the vascular access device is fully covered by the movable collar in the initial position. In some embodiments, the needle cannula of the vascular access device is fully exposed by a distance Df in the aspiration position. In some embodiments, the distance Df is 6 mm.

[0013] In some embodiments, the needle cannula of the vascular access device is partially exposed at the injection location by a distance Dn, hi some embodiments, the distance Dn is 4 mm.

[0014] In some embodiments, advancing the movable collar from the initial position causes the cam contact surface of the movable collar to abut the crescent shaped cam on the tab, causing the tab to pivot outwardly about the living hinge.

[0015] In some embodiments, depressing the tab advances the movable collar to the injection position.

[0016] A second aspect of the present disclosure relates to a vascular access device having a cylindrical base, a cammed slide disposed on the cylindrical base, and a biasing element disposed between a distal wall of the cammed slide and a proximal wall of the cylindrical base.

[0017] In some embodiments, the cylindrical base has a proximal end, a distal end, a proximal wall, and an elongated tip extending from the proximal wall. In some embodiments, the elongated tip further includes an opening extending therethrough. In some embodiments, the cylindrical base has an outer cylindrical wall and a cavity defined by the elongated tip, the outer cylindrical wall, and the proximal wall. In some embodiments, the cylindrical base also has a cam path disposed on an outer surface of the outer cylindrical wall, and the distal end has a snap element.

[0018] In some embodiments, the cammed slide is disposed on a cylindrical base having a proximal end, a distal end, and an inner surface, the distal end having a distal wall, the inner surface having an inwardly extending peg and a slot, the peg configured to move within the cam path.

[0019] The biasing element is configured to apply a biasing force.

[0020] In some embodiments, the peg advances along the cam path between at least three points, a first point defining an initial position, a second point defining an aspiration position, and a third point defining an injection position, wherein the needle cannula is fully covered in the initial position, the needle cannula is fully exposed at a distance D1 in the aspiration position, and the needle cannula is partially exposed at a distance D2 in the injection position. In some embodiments, the distance D1 is 6 mm and the distance D2 is 4 mm.

[0021] In some embodiments, the proximal wall includes a cavity for receiving the distal end of a vascular access device.

[0022] In some embodiments, the distal wall of the cammed slide includes a proximally extending inner collar.

[0023] In some embodiments, the peg is disposed in a plane perpendicular to the slot, and the peg is disposed proximal to the slot.

[0024] In some embodiments, the pegs can advance in a clockwise or counterclockwise direction.

[0025] In some embodiments, the snap element includes a flat surface and an angled surface opposite the angled surface.

[0026] In some embodiments, the biasing element is configured to continuously hold the cammed slide in an initial position such that the needle cannula is covered.

[0027] In some embodiments, depressing the cammed slide proximally relative to the cylindrical base with a downward force greater than the biasing force reversibly advances the cammed slide to the suction position. In some embodiments, depressing the cammed slide proximally relative to the cylindrical base with a downward force greater than the biasing force irreversibly advances the cammed slide to the suction position.

[0028] In some embodiments, removing the depressing force causes the cammed slide to enter the injection position.

[0029] In some embodiments, the cammed slide is held in the injection position by a cylindrically based snap element that intersects with a slot in the cammed slide, hi some embodiments, the cammed slide returns to its initial position upon application of a rotational release force. [Brief explanation of the drawings]

[0030] [Figure 1] FIG. 1 shows a side view of a vascular access device attached to a syringe in accordance with one or more embodiments of the present disclosure. [Figure 2] FIG. 2 shows an exploded side view of a vascular access device according to one or more embodiments of the present disclosure. [Figure 3] FIG. 3 shows a detailed cross-sectional view of a vascular access device according to one or more embodiments of the present disclosure. [Figure 4]FIG. 4 shows a perspective view of a base of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 5] FIG. 5 shows a perspective view of a base of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 6] FIG. 6 shows a perspective view of a steerable insert of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 7] FIG. 7 shows a perspective view of a steerable insert of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 8] FIG. 8 illustrates an initial position of a vascular access device according to one or more embodiments of the present disclosure. [Figure 9] FIG. 9 illustrates an aspiration position of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 10] FIG. 10 illustrates an injection position of a vascular access device according to one or more embodiments of the present disclosure. [Figure 11] FIG. 11 illustrates a vascular access device in an initial position according to one or more embodiments of the present disclosure. [Figure 12] FIG. 12 illustrates a vascular access device in an aspiration position in accordance with one or more embodiments of the present disclosure. [Figure 13] FIG. 13 illustrates a vascular access device in an aspiration position in accordance with one or more embodiments of the present disclosure. [Figure 14] FIG. 14 illustrates a vascular access device in an injection position according to one or more embodiments of the present disclosure. [Figure 15] FIG. 15 shows a side view of a vascular access device attached to a syringe in accordance with one or more embodiments of the present disclosure. [Figure 16] FIG. 16 shows an exploded side view of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 17] FIG. 17 shows a detailed cross-sectional view of a vascular access device according to one or more embodiments of the present disclosure. [Figure 18] FIG. 18 shows a perspective view of a base of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 19] FIG. 19 shows a side view of a base of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 20] FIG. 20 shows a detailed view of the base of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 21] FIG. 21 shows a perspective view of a slide of a vascular access device according to one or more embodiments of the present disclosure. [Figure 22] FIG. 22 shows a perspective view of a slide of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 23] FIG. 23 illustrates an initial position of a vascular access device according to one or more embodiments of the present disclosure. [Figure 24] FIG. 24 illustrates an aspiration position of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 25] FIG. 25 illustrates an injection position of a vascular access device according to one or more embodiments of the present disclosure. [Figure 26A] FIG. 26A illustrates a method of use of a vascular access device according to one or more embodiments of the present disclosure. [Figure 26B] FIG. 26B illustrates a method of use of a vascular access device according to one or more embodiments of the present disclosure. [Figure 26C] FIG. 26C illustrates a method of use of a vascular access device according to one or more embodiments of the present disclosure. [Figure 26D] FIG. 26D illustrates a method of use of a vascular access device according to one or more embodiments of the present disclosure. [Figure 26E] FIG. 26E illustrates a method of use of a vascular access device according to one or more embodiments of the present disclosure. [Figure 26F] FIG. 26F illustrates a method of use of a vascular access device according to one or more embodiments of the present disclosure. [Figure 26G] FIG. 26G illustrates a method of use of a vascular access device according to one or more embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0031] Before describing several example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0032] For purposes of the following description, the terms "proximal," "distal," "longitudinal," and their derivatives shall refer to the present disclosure as illustrated in the drawings. However, it will be understood that the present disclosure may be subject to alternative variations unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the following specification, are merely exemplary embodiments of the present disclosure. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0033] As used herein, the use of "a," "an," and "the" includes the singular and plural.

[0034] As used herein, the term "Luer connector" refers to a connecting collar, a standard method for attaching syringes, catheters, hubbed needles, IV tubing, and the like. Luer connectors consist of one or more interlocking tubes that are slightly tapered for a simple pressure / torsion / friction fit. Luer connectors can optionally have an outer periphery of threads added for added security. The male end of a Luer connector can interlock with the female end of a vascular access device (VAD). Luer connectors consist of a distal end, a proximal end, an irregularly shaped outer wall, and a profiled central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. Luer connectors also have a distal end channel that detachably attaches to the hub of the VAD and a proximal end channel that detachably attaches to the syringe barrel. As used herein, the term "Luer connector" refers to a male or female Luer connector.

[0035] As used herein, the term "medical device" refers to a general medical device having a threaded or interlocking connection, the connection having a corresponding mating element. By way of example, but not limitation, a syringe may have a male threaded connection that releasably interlocks with a secondary medical device, such as a male Luer connection on a catheter or IV line. The threaded connection includes a lumen defining a fluid pathway surrounded by a protruding wall having threaded means for attachment to the secondary medical device.

[0036] As will be readily understood by one of ordinary skill in the relevant art, descriptive terms such as "thread," "taper," "tab," "wall," "proximal," "side," "distal," and the like are used throughout this specification for ease of understanding, but are not intended to limit any components that may be used in combination or individually to implement various aspects of the embodiments of the present disclosure.

[0037] Embodiments of the present disclosure relate to vascular access devices with adjustable needle length for penetrating a vial stopper at the full needle length and penetrating a patient's skin at a desired needle length less than the full needle length. The vascular access devices described herein can be integrated into a syringe barrel or attached to a syringe barrel's unnecessary connector. The vascular access devices described herein can be integrated into any medical device for withdrawing or injecting medication from a vial and into a patient's skin. In some embodiments, the vascular access device is integral to or removably connectable to an insulin syringe.

[0038] For insulin administration, needle cannulas typically have a length of 6 mm because such a length allows them to penetrate the stopper of a standard insulin vial at any angle and reach the insulin in the vial for insulin aspiration. The same needle cannula used to withdraw medication from the vial is then used to inject the medication into the patient's skin. For insulin administration, the insulin medication is administered into the subcutaneous layer below the skin to ensure rapid and uniform distribution of the insulin throughout the patient's body. However, a 6 mm cannula length would result in the needle passing through the subcutaneous layer and entering the underlying muscle layer, which is undesirable. Embodiments of the present disclosure have a passive feature that allows a needle cannula (for example, but not limited to, a 6 mm needle cannula) to be fully inserted into the vial at any angle, but only partially inserted into the patient's skin at a desired skin depth (for example, but not limited to, into the subcutaneous layer below the skin).

[0039] Figures 1-14 show an embodiment of a vascular access device 100 having a slide mechanism for partially inserting a fixed length needle cannula into a patient's skin at a desired skin depth. Figures 15-26 show an embodiment of a vascular access device 200 having a cammed slide for partially inserting a fixed length needle cannula into a patient's skin at a desired skin depth.

[0040] Throughout the figures (FIGS. 1-26), a conventional vial 40 is shown. The vial 40 has a cylindrical body 42 having a cavity for storing a medication. The cylindrical body 42 has a closed base and a neck 44 opposite the closed base. The neck 44 has an opening 46 into which a rubber stopper 50 is inserted to form a seal. In some embodiments, the neck 44 further comprises a flange 48. In some embodiments, the rubber stopper 50 has a trapezoidal shape. In some embodiments, the rubber stopper 50 has a width substantially equal to the width of the flange 48. As shown in the figures, a needle cannula penetrates a top surface 52 of the rubber stopper 50 to withdraw the medication from the vial 40.

[0041] Throughout the figures (FIGS. 1-26), a conventional syringe 70 is shown. The syringe 70 includes a barrel 72 having a distal end 76. The syringe further includes a plunger rod 74 that can be partially withdrawn from the barrel 72, creating an internal negative pressure within the barrel 72 so that a fluid or agent can be drawn into the barrel 72. Similarly, the plunger rod 74 can be pushed into the barrel 72, creating an internal positive pressure buildup so that a fluid or agent can be expelled from the barrel 72. In some embodiments, the distal end 76 is integral to one or more of the vascular access devices (100, 200), as described in further detail below. In some embodiments, the distal end 76 is removably attachable to one or more of the vascular access devices (100, 200), as described in further detail below. In some embodiments, the distal end 76 is removably attachable to one or more of the vascular access devices (100, 200) via a needleless connection.

[0042] As shown in Figures 1-14, a vascular access device 100 according to one or more embodiments includes a cylindrical base 110 and a movable collar 150. Figure 1 shows an assembled view of the vascular access device 100 on a syringe 70, and Figure 2 shows an exploded view of the vascular access device. As shown in Figures 1 and 2, in some embodiments, the vascular access device further includes a sterilization cap 190. As described in further detail below, the movable collar 150 is translatable proximally and distally within the cylindrical base to decrease or increase the effective length of the needle cannula 80.

[0043] As shown in FIGS. 2-4 , the base 110 has a cylindrical shape including a proximal end 112 and a distal end 140 having a distal surface 142. The proximal end 112 includes a proximal wall 114 having an elongated tip 116 extending distally. In some embodiments, the elongated tip 116 extends distally beyond the distal end 140 and the distal surface 142. In some embodiments, the elongated tip 116 extends to the distal end 140 and shares a common distal surface 142 with the distal end 140. In some embodiments, a cavity extends distally from the proximal wall 114, and the cavity 120 extends a distance into the elongated tip. The cavity 120 is configured to receive the distal end 76 of the syringe 70. The elongated tip 116 includes an opening 122 extending through the elongated tip 116 and in fluid communication with the cavity 120.

[0044] As best shown in FIG. 5 , elongate tip 116 has a proximal portion 117 and a distal portion 118, with proximal portion 117 adjacent proximal wall 114 and having a larger diameter than distal portion 118. As shown in FIG. 5 , cavity 120 extends within proximal portion 117. Proximal portion 117 has an outer surface 119 with one or more longitudinal slots 124. One or more longitudinal slots 124 extend from proximal wall 114 a distal distance along proximal portion 117 of elongate tip 116. One or more longitudinal slots 124 are configured to intersect with snap locks 156 of movable collar 150, as described in further detail below. The distance of the one or more longitudinal slots 124 provides a longitudinal travel distance limit for the movable collar 150 as the snap lock 156 can move from the proximal wall 114 to the distance of the one or more longitudinal slots 124 .

[0045] As best shown in FIG. 5 , the outer cavity 126 of the base 110 separates the elongated tip 116 from the outer cylindrical wall 128 such that the elongated tip 116 is surrounded by the outer cylindrical wall 128. The outer cylindrical wall 128 extends from the proximal wall 114 to the distal end 140. Stated another way, the outer cylindrical wall 128 surrounds the outer cavity 126 and the elongated tip 116. Because the elongated tip 116 has a proximal portion 117 that has a diameter larger than the diameter of the distal portion 118, a contact surface 130 is formed between the proximal and distal portions 117, 118 of the elongated tip. As shown in FIG. 3 , the sterilization cap 190, when placed over the elongated tip 116, is seated against the contact surface 130. The sterilization cap 190 has a hollow cylindrical body configured to create an interference fit with the distal portion 118 of the elongated tip 116. Additionally, the sterility cap 190 has an outer diameter that is equal to or less than the diameter of the proximal portion 117 of the elongate tip 116 such that the outer surface 192 of the sterility cap 190 does not protrude or project laterally beyond the proximal portion 117. As described in further detail below, the movable collar 150 is movable longitudinally in the proximal and distal directions such that the movable collar 150 can move between the outer cylindrical wall 128, the mating outer surface 192 of the sterility cap 190, and the proximal portion 117 of the elongate tip 116.

[0046] 4, the outer cylindrical wall 128 has a notch 132 that extends a distance proximally from a distal surface 142 at least partially the length of the outer cylindrical wall 128. In some embodiments, the notch 132 extends into the proximal wall 114. The notch 132 is at least partially covered by a tab 134 that is connected to a distal end 140 and to the distal surface 142 of the outer cylindrical wall 128 by a living hinge 136 that provides a pivot for the tab 134 to rotate relative to the distal surface 142.

[0047] FIG. 4 illustrates tab 134 in the open position, and FIG. 5 illustrates tab 134 in the closed position. As shown, tab 134 substantially covers notch 132. In some embodiments, inner surface 137 of tab 134 has a longitudinal protrusion 138 configured to create an interference or snap fit with a corresponding slot 139 in proximal wall 114. As shown in FIGS. 4 and 5 , inner surface 137 of tab 134 further includes a distally disposed crescent cam 144. A stem 146 of crescent cam 144 extends inward, and a distal peak 148 of crescent cam 144 faces distally when in the closed position, as shown in FIG. 3 . As described in more detail below, advancing movable collar 150 proximally causes a contact surface of movable collar 150 to press against distal peak 148, causing tab 134 to rotate about living hinge 136 and enter the open position, as shown in FIG. 4 . As will be explained in more detail below, the tab 134 provides the practitioner with a visual indication of the relative position of the movable collar 150 .

[0048] As shown in FIGS. 3 , 6 , and 7 , the movable collar 150 comprises a hollow cylindrical body having a proximal end 152 and a distal end 154. Extending from the distal end 154 is a flange 158 configured to seat against the outer cylindrical wall 128. In some embodiments, the flange 158 further comprises a relief cutout 160 so that the flange 158 does not interfere with the tab 134 and the living hinge 136 when the flange 158 is seated against the outer cylindrical wall 128. The proximal end 152 comprises one or more snap locks 156 that create a snap fit with the one or more longitudinal slots 124 of the elongated tip 116. The one or more snap locks 156 allow the movable collar 150 to move proximally and distally but prevent the movable collar 150 from being completely removed from the cylindrical base 110. In some embodiments, the clearance cutout 162 extends a distance along the movable collar 150 from the proximal end 152. The clearance cutout 162 is configured so as not to interfere with the crescent cam 144.

[0049] 3, clearance cutout 162 includes a cam contact surface 164. When movable collar 150 is advanced proximally within outer cavity 126, cam contact surface 164 contacts distal peak 148 of crescent cam 144, causing tab 134 to pivot about living hinge 136.

[0050] 8-10 illustrate the initial, aspiration, and injection positions of the vascular access device. As shown in FIG. 8, in the initial position, tab 134 is closed and movable insert 150 fully translates the needle cannula (not shown). As shown in FIG. 9, proximal advancement of movable insert 150 brings cam contact surface 164 into contact with distal peak 148 of crescent cam 144, causing tab 134 to pivot about living hinge 136. This is the aspiration position, with needle cannula 80 fully exposed at distance Df. In some embodiments, distance Df is 6 mm. A distance Df of 6 mm is preferred for aspiration of insulin vials. With tab 134 pivoting outward, the user has a visual indication that vascular access device 100 is in the aspiration position. To place the vascular access device in the injection position, the user closes tab 134 to place it in the closed position. Crescent cam 144 pushes movable collar 150 distally a distance Dc, thereby reducing needle cannula 80 distance Df to effective distance Dn. In some embodiments, distance Df is 6 mm, distance Dc is 2 mm, and effective needle cannula 80 distance Dn is 4 mm. 4 mm penetrates the subcutaneous layer of the patient's skin 20 but does not penetrate the muscle layer.

[0051] Figure 11 shows the vascular access device 100 in an initial position, Figures 12 and 13 show the vascular access device 100 in an aspiration position, and Figure 14 shows the vascular access device 100 in an injection position.

[0052] 11 and 12, a method of using vascular access device 100 includes removing sterilization cap 190 and pressing movable insert 150 against rubber stopper 50 of vial 40 until movable insert 150 biases against crescent cam 144, thus pivoting tab 134 outward. As shown in FIGS. 13 and 14, the method further includes removing vascular access device 100 from vial 40, pressing tab 134 inward, and bringing the vascular access device to an injection position. vascular access device 100 may then be inserted into the patient's skin at the injection position.

[0053] As shown in Figures 15-25, a vascular access device 200 according to one or more embodiments includes a cylindrical base 210, a cammed slide 250, and a biasing element 280. Figure 15 shows an assembled view of the vascular access device 200 on the syringe 70, and Figure 16 shows an exploded view of the vascular access device 200. As shown in Figures 15 and 16, in some embodiments, the vascular access device further includes a sterilization cap 290. As described in further detail below, the cammed slide 250 is translatable proximally and distally on the cylindrical base to decrease or increase the effective length of the needle cannula 80.

[0054] As shown in FIGS. 16-20 , the base 210 has a cylindrical shape including a proximal end 212 and a distal end 240 having a distal surface 242. In some embodiments, the proximal wall 214 is disposed at the proximal end 212. In some embodiments, the proximal wall 214 is disposed at a distance from the proximal end 212. The proximal wall 214 has an elongated tip 216 extending distally. In some embodiments, the elongated tip 216 extends distally beyond the distal end 240 and the distal surface 242. In some embodiments, the elongated tip 216 extends to the distal end 240 and shares a common distal surface 242 with the distal end 240. In some embodiments, a cavity extends distally from the proximal wall 214, and the cavity 220 extends a distance into the elongated tip. The cavity 220 is configured to receive the distal tip 76 of the syringe 70. The elongate tip 216 includes an opening 222 extending therethrough and in fluid communication with the cavity 220 .

[0055] As best shown in FIG. 17 , the outer cavity 226 of the base 210 separates the elongated tip 216 from the outer cylindrical wall 228 such that the elongated tip 216 is surrounded by the outer cylindrical wall 228. The outer cylindrical wall 228 extends from the proximal wall 214 to the distal end 240. Stated another way, the outer cylindrical wall 228 surrounds the outer cavity 226 and the elongated tip 216. As shown in FIG. 17 , the sterility cap 290, when placed over the elongated tip 216, is seated against the proximal wall 214. The sterility cap 290 has a hollow cylindrical body configured to create an interference fit with the elongated tip 216.

[0056] As shown in FIGS. 17-20 , the outer cylindrical wall 228 includes a cam path 232 disposed on an outer surface 230 of the outer cylindrical wall 228. In some embodiments, the cam path 232 is an S-shaped notch in the thickness of the outer cylindrical wall 228 configured to receive a peg 252 of the cammed slide 250, as described in further detail below. The cam path 232 extends around the outer cylindrical wall 228 and includes at least three points (234, 236, 238) within which the peg 252 of the cammed slide 250 rests at least partially (as best shown in FIG. 19 ): the first point 234 defines an initial position, the second point 236 defines an aspiration position, and the third point 238 defines an injection position. As described in further detail below, the peg 252 of the cammed slide 250 can move in a clockwise or counterclockwise direction between at least three points (234, 236, 238). In other words, the positions are reversible, such that the peg 252 of the cammed slide 250 can move from the first point 234 (initial position) to the third point 238 (injection position) through the second point 236 (injection position), and can also reversibly move from the third point 238 (injection position) to the first point 234 (initial position) through the second point 236 (injection position).

[0057] Outer cylindrical wall 228 further comprises a snap element 244 extending laterally from the exterior or outer cylindrical wall 228 at distal end 240. In some embodiments, snap element 244 includes a flat surface 246 opposite a ramped surface 249. In embodiments in which cammed slide 250 is moving counterclockwise between at least three points (234, 236, 238), flat surface 246 is in front of ramped surface 249 (as shown in FIG. 20 ). In embodiments in which cammed slide 250 is moving clockwise between at least three points (234, 236, 238), ramped surface 249 is in front of flat surface 246. As described in more detail below, the snap element is configured to intersect with a slot in the cammed slide. The snap elements 244 and slots in the cammed slide 250 are configured to create a soft stop where the user must apply additional force to the cammed slide 250 to advance to adjacent positions of at least three points (234, 236, 238).

[0058] 21 and 22, cammed slide 250 comprises a hollow cylindrical body having a proximal end 253 and a distal end 254. Distal end 254 has a distal wall 256 with an inner collar 248 extending proximally relative to distal end 254 and distal wall 256. Inner collar 248 has an inner diameter for receiving a sterilization cap 290. The inner surface 258 of the hollow cylindrical body of cammed slide 250 comprises an inwardly extending peg 252 and a slot 260. As shown in FIG. 22, peg 252 is disposed in a plane perpendicular to slot 260, with peg 252 disposed proximal to slot 260.

[0059] Cammed slide 250 is positioned on cylindrical base 210 such that peg 252 is within cam path 232. As peg 252 rotates within cam path 232, the entire cammed slide 250 rotates about cylindrical base 210 and translates in a clockwise or counterclockwise direction between at least three points (234, 236, 238). In other words, the position is reversible, such that peg 252 of cammed slide 250 can move from first point 234 through second point 236 to third point 238, and can also move reversibly from third point 238 through second point 236 to first point 234.

[0060] Figures 23-25 ​​show cammed slide 250 at least partially disposed on cylindrical base 210, and rotatably advanceable peg 252 of cammed slide 250 disposed within cam path 232 of cylindrical base 210. Figure 23 shows the initial position, Figure 24 shows the aspiration position, and Figure 25 shows the injection position.

[0061] 23 , first point 234 is located distally from both second point 236 and third point 238. The location of first point 234 places cammed slide 250 in a fully extended position in which cammed slide 250 completely covers needle cannula 80. Distal end 254 of cammed slide 250 is a distance D1 from distal end 240 of cylindrical base 210. Distance D1 (essentially the projection distance of distal end 254 of cammed slide 250 past distal end 240 of cylindrical base 210) completely covers needle cannula 80.

[0062] 24, second point 236 is located proximal to both first point 234 and third point 238. The location of second point 236 places cammed slide 250 in a fully retracted position with needle cannula 80 fully exposed by distance D. In some embodiments, in the aspirating position, distal wall 256 abuts distal end 240 of cylindrical base 210. In some embodiments, in the aspirating position, distance D is 6 mm, which is a standard needle size for aspirating medication from an insulin vial.

[0063] 25, third point 238 is located proximal to first point 234 and distal to second point 236. The location of third point 238 places cammed slide 250 in a partially retracted position in which needle cannula 80 is partially exposed by a distance D2. In some embodiments, distance D2 is configured to penetrate the subcutaneous layer of the patient's skin but not the muscle layer. In some embodiments in which distance D is 6 mm, distance D2 is 4 mm. Furthermore, in the injection position, slot 260 of cammed slide 250 intersects snap element 244 such that cammed slide 250 cannot further rotate or translate proximally or distally without a force required to overcome snap element 244, as described in more detail below.

[0064] 16, 17, 23, and 25, biasing element 280 is biased against proximal wall 214 of cylindrical base 210 and distal wall 256 of cammed slide 250. The biasing element is disposed within outer cavity 226, more specifically, between inner collar 248 of cammed slide 250 and outer cylindrical wall 228 of cylindrical base 210. Biasing element 280 exerts a biasing force on cammed slide 250 in a distal direction relative to cylindrical base 210. As previously mentioned, the position is reversible, such that peg 252 of cammed slide 250 can move from first point 234 through second point 236 to third point 238, and can also reversibly move from third point 238 through second point 236 to first point 236. In some embodiments, biasing element 280 is configured to continuously hold cammed slide 250 in an initial position so that needle cannula 80 is always covered. Pressing cammed slide 250 proximally against cylindrical base 210 with a downward force greater than the biasing force reversibly advances cammed slide 250 to the aspiration position.

[0065] In some embodiments, the cammed slide 250 and vascular access device 200 remain in the aspiration position until the practitioner or user advances the cammed slide 250 distally against a surface, such as a rubber stopper of a vial, with a downward force. The vascular access device 200 remains in the aspiration position as long as the cammed slide 250 is pressed down against the surface with a downward force, fully exposing the needle cannula 80 only while the needle cannula 80 is within the rubber stopper. Pulling the cammed slide 250 off the surface places the cammed slide 250 and vascular access device 200 in the injection position. As previously described, the cammed slide 250 is held in the injection position by the snap element 244 of the cylindrical base 210, which intersects with the slot 260 in the cammed slide 250. With the cammed slide 250 held so that the needle cannula is exposed a distance D2 (as shown in FIG. 25 ), the user or practitioner can insert the needle cannula 80 into the patient's skin without further movement of the cammed slide 250. Stated another way, snap element 244 and slot 260 are configured as a soft stop. After administering the agent to the subcutaneous layer of the patient's skin, the user or practitioner can either completely dispose of vascular access device 200, or reinstall sterilization cap 290 while the vascular access device is still in the injection position, and dispose of vascular access device 200 and sterilization cap 290. In some embodiments, snap element 244 includes flat surface 246 and angled surface 249 and is configured to prevent cammed slide 250 from rotating in the opposite direction and thus prevent vascular access device 200 from returning to its initial position.

[0066] In some embodiments, releasing the downward force on the cammed slide 250 reversibly returns the cammed slide 250 to its initial position. The biasing force is directed distally relative to the cylindrical base 210, and the downward force is opposite the biasing force proximally relative to the cylindrical base 210. The biasing and downward forces cause the cammed slide 250 to move longitudinally, which also rotates between the initial position and the aspiration position. Only application of a rotational force (by the practitioner's or user's hand) moves the cammed slide 250 into the injection position. The rotational force can be clockwise or counterclockwise. As previously mentioned, the cammed slide 250 is held in the injection position by the snap element 244 on the cylindrical base 210, which intersects with the slot 260 on the cammed slide 250. The cammed slide 250 cannot be released from the injection position by a longitudinal force because the cam path 232 is essentially a worm gear. To release from the injection position, the user must, in some embodiments, apply a rotational release force greater than or equal to the rotational force required to enter the injection position. In other words, snap element 244 and slot 260 are configured as a soft stop. Upon release from the injection position by applying a rotational release force, the biasing element causes cammed slide 250 to enter its initial position, fully covering needle cannula 80.

[0067] 23, the needle cannula 80 is fully covered by the cammed slide 250 and the vascular access device 200 remains in the initial position due to the biasing element 280. Advancement of the vascular access device 200 against a surface, such as a rubber stopper of a vial, applies the necessary downward force to fully expose the needle cannula 80 in the aspirating position, where the practitioner or user can withdraw medication from the vial.

[0068] In some embodiments, removing the vascular access device 200 from the vial advances the vascular access device 200 to the injection position. In some embodiments, removing the vascular access device 200 from the vial returns the vascular access device 200 to its initial position. In some embodiments, applying a rotational force causes the vascular access device 200 to enter the injection position and remain partially locked.

[0069] In the injection position, the needle cannula 80 is partially exposed by a distance D2 such that the needle cannula penetrates only the patient's skin within the subcutaneous layer of the patient's skin, but not the muscle layer. In the injection position, the practitioner or user can inject medication into the subcutaneous layer of the patient's skin. To dispose of the vascular access device 200, the sterilization cap 90 can be replaced and disposed of.

[0070] 21 and 22 , in some embodiments, the cammed slide 250 further comprises markings 262 that indicate to the user the direction of rotational motion that the user must use to actuate the vascular access device 200. In some embodiments, the cammed slide 250 further includes gripping indentations to assist in manipulation of the vascular access device 200.

[0071] As shown in Figures 26A to 26D, a method of using vascular access device 200 includes the steps of advancing cammed slide 250 of vascular access device 200 into stopper 50 of vial 40 by applying a compressive force to stopper 50 such that vascular access device 200 advances from an initial position to an aspiration position, withdrawing the medication from vial 40, withdrawing vascular access device 200 from vial 40 which advances vascular access device 200 from the aspiration position to an injection position using a biasing force, inserting vascular access device 200 into the patient's skin, injecting the medication into the subcutaneous layer of the patient's skin, withdrawing the vascular access device from the patient's skin, and rotating vascular access device 200 to the initial position.

[0072] While the present disclosure has been shown and described with reference to specific exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the embodiments of the present disclosure. Also, the inner and / or outer housing of the cap can be one-shot molded or made by other suitable processes. Furthermore, the features or elements of the exemplary implementations of the embodiments of the present disclosure described above and illustrated in the drawings can be implemented individually or in any combination, as will be readily understood by those skilled in the art, without departing from the spirit and scope of the embodiments of the present disclosure.

[0073] Additionally, the accompanying drawings further illustrate non-limiting examples of certain exemplary embodiments of the present disclosure and aid in explaining the technology associated therewith. Specific or relative dimensions or measurements shown in the above drawings and elsewhere are exemplary and are not intended to limit the scope or content of the inventive designs or methods as would be understood by one of ordinary skill in the relevant art of the invention.

[0074] References throughout this specification to "one embodiment," "a particular embodiment," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with an embodiment is included in at least one embodiment of the disclosure. That is, the appearances of phrases such as "in one or more embodiments," "in a particular embodiment," "in one embodiment," or "in an embodiment" in various places throughout this specification do not necessarily refer to the same embodiment of the disclosure. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0075] Although the present disclosure has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and device without departing from the spirit and scope of the invention. Therefore, it is intended that the present disclosure cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. 1. A vascular access device comprising: a cylindrical base having a proximal end and a distal end, the proximal end having a proximal wall and an elongated tip extending from the proximal wall, the elongated tip having one or more longitudinal slots, the cylindrical base further having an outer cylindrical wall and an outer cavity between the outer cylindrical wall and the elongated tip, the outer cylindrical wall having a notch extending from the distal end to the proximal wall; a tab connected to the distal end of the outer cylindrical wall with a living hinge connecting the tab to the outer cylindrical wall, the tab configured to pivot about the living hinge, the tab covering the notch in the cylindrical base in a closed position, the tab further comprising a crescent-shaped cam having a stem and a distal peak, the distal peak extending distally in the closed position; a movable collar disposed within the outer cavity, the movable collar having a proximal end and a distal end, the distal end including one or more snap locks configured to move within the one or more longitudinal slots, the movable collar further including a clearance cutout extending from the distal end a distance along the movable collar, the clearance cutout having a cam contact surface.

2. 2. The device of claim 1, wherein the elongate tip includes a proximal portion and a distal portion, the distal portion having an outer surface, the elongate tip further including an opening extending therethrough, and the one or more longitudinal slots extend on the proximal portion.

3. The device of claim 2 , wherein an interface is formed between the proximal and distal portions of the elongate tip.

4. The device of claim 3 , wherein a sterile cap is inserted over the elongate tip and contacts the contact surface.

5. The device of claim 1 , wherein the living hinge further comprises one or more longitudinal protrusions configured to create a snap fit with corresponding slots disposed in the proximal wall.

6. The device of claim 1 , wherein the proximal wall comprises a cavity for receiving a distal end of a vascular access device.

7. 2. The device of claim 1, wherein the movable collar further comprises a distal flange configured to abut the distal end of the outer cylindrical wall when the movable collar is fully advanced within the cylindrical base.

8. The device of claim 1 , wherein the movable collar has an initial position, an aspiration position, and an injection position.

9. The device of claim 8 , wherein the needle cannula of the vascular access device is fully covered by the movable collar in the initial position.

10. The device of claim 8 , wherein the needle cannula of the vascular access device is fully exposed a distance Df in the aspiration position.

11. The device of claim 10, wherein the distance Df is 6 mm.

12. The device of claim 8 , wherein the needle cannula of the vascular access device is partially exposed a distance Dn at the injection location.

13. The device of claim 12, wherein the distance Dn is 4 mm.

14. 9. The device of claim 8, wherein advancing the movable collar from the initial position causes the cam contact surface of the movable collar to abut the crescent shaped cam of the tab, causing the tab to pivot outward about the living hinge.

15. The device of claim 14 , wherein depressing the tab advances the movable collar to the injection position.

16. 1. A vascular access device comprising: a cylindrical base having a proximal end, a distal end, a proximal wall, and an elongated tip extending from the proximal wall, the elongated tip further comprising an opening extending therethrough, the cylindrical base having an outer cylindrical wall and a cavity defined by the elongated tip, the outer cylindrical wall, and the proximal wall, the cylindrical base further having a cam path disposed on an outer surface of the outer cylindrical wall, the distal end having a snap element; a cammed slide disposed on the cylindrical base having a proximal end, a distal end, and an inner surface, the distal end having a distal wall, the inner surface having an inwardly extending peg and a slot, the peg configured to move within the cam path; a biasing element disposed between the distal wall of the cammed slide and the proximal wall of the cylindrical base, the biasing element configured to apply a biasing force; the peg advances along the cam path between at least three points, a first point defining an initial position, a second point defining an aspiration position, and a third point defining an injection position, wherein the needle cannula is fully covered in the initial position, the needle cannula is fully exposed at a distance D1 in the aspiration position, and the needle cannula is partially exposed at a distance D2 in the injection position; A vascular access device wherein the cammed slide is held in the injection position by the snap element on the cylindrical base intersecting the slot on the cammed slide.

17. The device of claim 16 , wherein the proximal wall comprises a cavity for receiving a distal end of a vascular access device.

18. The device of claim 16 , wherein the distal wall of the cammed slide includes a proximally extending inner collar.

19. The device of claim 16 , wherein the peg is disposed in a plane perpendicular to the slot, the peg being disposed proximally relative to the slot.

20. 17. The device of claim 16, wherein the peg can be advanced in a clockwise or counterclockwise direction.

21. 17. The device of claim 16, wherein the snap element comprises a flat surface and a sloped surface opposite the sloped surface.

22. 17. The device of claim 16, wherein the distance D1 is 6 mm and the distance D2 is 4 mm.

23. 17. The device of claim 16, wherein the biasing element is configured to continuously hold the cammed slide in the initial position such that the needle cannula is covered.

24. 17. The device of claim 16, wherein depressing the cammed slide proximally against the cylindrical base with a downward force greater than the biasing force reversibly advances the cammed slide to the suction position.

25. 17. The device of claim 16, wherein depressing the cammed slide proximally against the cylindrical base with a downward force greater than the biasing force irreversibly advances the cammed slide to the suction position.

26. 26. The device of claim 25, wherein the cammed slide enters the injection position upon withdrawal of the depressing force.

27. 27. The device of claim 26, wherein the cammed slide returns to the initial position upon application of a rotational release force.

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