Vascular access device with active needle length adjustment

Abstract

To provide a disposable needle vascular access device capable of properly withdrawing a medicament from a vial and then administering the medicament to a subcutaneous layer under the skin.SOLUTION: A vascular access device having needle length adjustability for penetrating a stoppered vial with a full needle length and for penetrating a patient's skin with a desired needle length less than the full needle length includes a cylindrical base, a compressible foamtip, and a needle cannula.SELECTED DRAWING: Figure 11

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 adjustable needle length for penetrating both an insulin vial and a 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 needle 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 integral, non-removable needle cannula fixed to the distal end of the barrel, or 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 pinch 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, interchangeable needle hubs can be used to first withdraw 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 flange, and a needle cannula. The cylindrical base has a proximal end and a distal end. The flange includes two prongs extending distally from the flange, each prong having a distal end extending a predetermined length from the flange. The two prongs are spaced a distance Dp from each other, the distance Dp being greater than the width Wv of the vial's rubber stopper so that the two prongs can pass through the rubber stopper. The vascular access device further includes a distal protrusion extending distally from the flange, the distal protrusion having a distal surface and an opening extending from the proximal end of the base to the distal surface of the distal protrusion. The needle cannula extends through the opening and extends a distance Dc from the distal surface of the distal protrusion. The two prongs extend a distance Dn from the distal surface of the distal protrusion.

[0007] In some embodiments, the proximal end of the cylindrical base is removably attached to or integral with the distal end of the syringe barrel, hi some embodiments, the needle cannula is secured to the distal end of the syringe barrel extending through an opening from the distal end of the barrel.

[0008] In some embodiments, the two prongs are substantially perpendicular to the flange and form a U-shape with the flange.

[0009] In some embodiments, the distance Dc is sufficient to pierce the rubber stopper of the vial. In some embodiments, the distance Dc is 6 mm and the vial is an insulin vial. In some embodiments, the needle cannula is sufficient to pierce the insulin vial at an angle ranging from 90 degrees to 45 degrees relative to the rubber stopper.

[0010] In some embodiments, the prongs are effective to limit the needle cannula from fully penetrating the patient's skin to only a distance Dn. In some embodiments, if the needle cannula has a distance Dc of 6 mm and a distance Dn of 2 mm, and the two prongs limit the distal face of the distal end from contacting the flat surface, the cannula can only insert 4 mm into the flat surface.

[0011] In some embodiments, the flange is connected to the base by a connection point on the flange that connects the flange to a pivot located at the distal end of the base. In some embodiments, the base and flange are separate components that snap together by the pivot on the flange and the connection point on the distal end of the base. In some embodiments, the pivot and connection point have an angular range of motion of 0 to 75 degrees. In some embodiments, the base and flange are of unitary construction and connected by a living hinge to provide a range of motion of the base of the flange relative to the base.

[0012] A second aspect of the present disclosure relates to a vascular access device having a cylindrical base, a compressible foam tip, and a needle cannula. The cylindrical base has a proximal end and a distal end, the distal end having an elongated tip and a collar extending therefrom, the collar surrounding the elongated tip, the elongated tip having an opening extending from the proximal end of the base to the elongated tip, the collar being spaced apart from the elongated tip, a channel being formed between the collar and the elongated tip, the channel having a distal surface. The compressible foam tip has proximal and distal ends and a proximal and distal portion, the distal portion having a diameter larger than the diameter of the proximal portion forming a contact surface, the compressible foam tip being inserted into and secured to the base, the distal surface of the base abutting the contact surface of the compressible foam tip, and the distal portion of the compressible foam tip being compressible from an initial uncompressed length Lu in an uncompressed state to a final compressed length Lc in a compressed state. The needle cannula extends through the opening and extends a distance Dc' from the distal portion in the uncompressed state. When the compressible foam tip is compressed to its final compressed state, the needle cannula extends a distance Dc' plus a length L.

[0013] In some embodiments, the proximal end of the cylindrical base is removably attached to or integral with the distal end of the syringe barrel. In some embodiments, the needle cannula is fixed to the distal end of the barrel and extends through an opening in the distal end of the syringe barrel. In some embodiments, the elongated tip and the collar extend the same length and share a distal surface. In some embodiments, the base further includes an adhesive channel at least partially within the channel below the distal end of the base, the adhesive channel being lateral to the channel. In some embodiments, the proximal end of the compressible foam tip is inserted into the adhesive channel, the proximal end of the compressible foam tip having a width substantially equal to the adhesive channel, and a cavity is formed between the elongated tip of the base and the proximal portion of the compressible foam tip.

[0014] In some embodiments, the compressible foam tip is compressed by applying a compressive force against the top surface of the rubber stopper such that the needle cannula is inserted into the top surface of the rubber stopper by the combined distance Dc' and length L.

[0015] In some embodiments, the distance Dc' is 4 mm, and the combined length of the distance Dc' and the length L is 6 mm.

[0016] A third aspect of the present disclosure is directed to a vascular access device having a cylindrical base with a proximal end and a distal end, the distal end including a distal end shape, the base including an opening extending through the base, the distal end shape having an inclined surface and a distal flat surface located distal to the inclined surface, the inclined surface being inclined at an angle θ relative to the base, the distal flat surface being located a distance Dn from the opening, and a needle cannula extending through the opening, the needle cannula extending from the inclined surface by a distance Dc at the opening.

[0017] In some embodiments, the distal flat surface includes a lateral extension. In some embodiments, distance Dc is 6 mm, distance Dn is 2 mm, and the needle cannula has an effective length of 4 mm. [Brief explanation of the drawings]

[0018] [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 2A] FIG. 2A shows a cross-sectional view of a vascular access device penetrating a vial in accordance with one or more embodiments of the present disclosure. [Figure 2B] FIG. 2B shows a cross-sectional view of a vascular access device penetrating a vial in accordance with one or more embodiments of the present disclosure. [Figure 3A] FIG. 3A shows a cross-sectional view of a vascular access device penetrating a vial in accordance with one or more embodiments of the present disclosure. [Figure 3B]FIG. 3B shows a cross-sectional view of a vascular access device penetrating a vial in accordance with one or more embodiments of the present disclosure. [Figure 4] FIG. 4 shows a cross-sectional view of a vascular access device penetrating the skin of a patient in accordance with one or more embodiments of the present disclosure. [Figure 5] FIG. 5 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 6] FIG. 6 shows a detailed perspective view of a vascular access device attached to a syringe in accordance with one or more embodiments of the present disclosure. [Figure 7] FIG. 7 shows a detailed side view of a vascular access according to one or more embodiments of the present disclosure. [Figure 8] FIG. 8 shows a cross-sectional view of a vascular access device penetrating a vial in accordance with one or more embodiments of the present disclosure. [Figure 9] FIG. 9 shows a cross-sectional view of a vascular access device penetrating a vial in accordance with one or more embodiments of the present disclosure. [Figure 10] FIG. 10 shows a cross-sectional view of a vascular access device penetrating the skin of a patient in accordance with one or more embodiments of the present disclosure. [Figure 11] FIG. 11 shows a perspective view of a vascular access device attached to a syringe in accordance with one or more embodiments of the present disclosure. [Figure 12] FIG. 12 shows an exploded side view of a vascular access device attached to a syringe in accordance with one or more embodiments of the present disclosure. [Figure 13A] FIG. 13A shows a detailed side view of a vascular access device according to one or more embodiments of the present disclosure. [Figure 13B] FIG. 13B shows a detailed cross-sectional view of a vascular access device according to one or more embodiments of the present disclosure. [Figure 14A] FIG. 14A shows a perspective view of a base of a vascular access device according to one or more embodiments of the present disclosure. [Figure 14B]FIG. 14B shows a cross-sectional view of the base of a vascular access device according to one or more embodiments of the present disclosure. [Figure 15A] FIG. 15A shows a perspective view of a foam tip of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 15B] FIG. 15B shows a cross-sectional view of a foam tip of a vascular access device in accordance with one or more embodiments of the present disclosure. [Figure 16] FIG. 16 shows a foam tip of a vascular access device in an initial, uncompressed state in accordance with one or more embodiments of the present disclosure. [Figure 17] FIG. 17 shows a foam tip of a vascular access device in a final compressed state in accordance with one or more embodiments of the present disclosure. [Figure 18] FIG. 18 shows a foam tip of a vascular access device in a final compressed state in accordance with one or more embodiments of the present disclosure. [Figure 19] FIG. 19 shows a foam tip of a vascular access device in an initial, uncompressed state in accordance with one or more embodiments of the present disclosure. [Figure 20A] FIG. 20A illustrates steps in a method for drawing a medication from a vial and administering the medication to a patient's skin, according to one or more embodiments of the present disclosure. [Figure 20B] FIG. 20B illustrates steps in a method for drawing a medication from a vial and administering the medication to a patient's skin, according to one or more embodiments of the present disclosure. [Figure 20C] FIG. 20C illustrates steps in a method for drawing a medication from a vial and administering the medication to a patient's skin, according to one or more embodiments of the present disclosure. [Figure 20D] FIG. 20D illustrates steps in a method for drawing a medication from a vial and administering the medication to a patient's skin, according to one or more embodiments of the present disclosure. [Figure 21] FIG. 21 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 22]FIG. 22 shows a detailed view of a vascular access device attached to a syringe in accordance with one or more embodiments of the present disclosure. [Figure 23] FIG. 23 shows a cross-sectional view of a vascular access device penetrating a vial in accordance with one or more embodiments of the present disclosure. [Figure 24] FIG. 24 shows a cross-sectional view of a vascular access device penetrating a vial in accordance with one or more embodiments of the present disclosure. [Figure 25] FIG. 25 shows a cross-sectional view of a vascular access device penetrating the skin of a patient in accordance with one or more embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] 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.

[0020] For purposes of the following description, the terms "proximal," "distal," "longitudinal," and their derivatives shall refer to the present disclosure as shown 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.

[0021] As used herein, the use of "a," "an," and "the" includes the singular and plural.

[0022] 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 / twist-fit / friction fit. Luer connectors can optionally have an outer perimeter of threads added for added security. Luer connectors can interlock with and connect to the 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 removably attaches to the hub of the VAD and a proximal end channel that removably attaches to the syringe barrel. As used herein, the term "Luer connector" refers to a male or female Luer connector.

[0023] 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 and not limitation, a syringe may have a threaded connection that releasably interlocks with a secondary medical device, such as a catheter, an IV line, or other unnecessary connector. The threaded connection may include a lumen defining a fluid pathway surrounded by a protruding wall having threaded means for attachment to the secondary medical device.

[0024] 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.

[0025] Embodiments of the present disclosure relate to vascular access devices with adjustable needle length for penetrating a stopper vial with the full length of the needle and penetrating a patient's skin with a desired needle length less than the full length of the needle. 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 integral to any medical device for withdrawing or injecting medication from a vial and injecting it into a patient's skin. In some embodiments, the vascular access device is integral to or removably connectable to an insulin syringe.

[0026] For insulin administration, a 6 mm needle cannula length is common because such a length allows it 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 insulin throughout the patient's body. However, a 6 mm cannula length results in the needle passing through the subcutaneous layer and into the underlying muscle layer, which is undesirable. In other words, upon injection, the muscle layer is perpendicular and below the subcutaneous layer. 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, the subcutaneous layer below the skin).

[0027] Figures 1-4 show an embodiment of a vascular access device 100 having a fixed flange for partially inserting a fixed-length needle cannula into a patient's skin at a desired skin depth. Figures 5-10 show an embodiment of a vascular access device 200 having a swivel-arm flange for partially inserting a fixed-length needle cannula into a patient's skin at a desired skin depth. Figures 11-20D show an embodiment of a vascular access device 300 having a depressible foam tip for partially inserting a fixed-length needle cannula into a patient's skin at a desired skin depth. Figures 21-25 show an embodiment of a vascular access device 400 having a cam shape for partially inserting a fixed-length needle cannula into a patient's skin at a desired skin depth.

[0028] A conventional vial 40 is illustrated throughout the figures (FIGS. 1-25). The vial 40 has a cylindrical body 42 with 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 through which a rubber stopper 50 is inserted to form a seal. In some embodiments, the neck 44 further includes 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 the top surface 52 of the rubber stopper 50 to withdraw the medication from the vial 40. As best shown in FIG. 3B, the rubber stopper 50 of the vial 40 has a width Wv.

[0029] Throughout the figures (FIGS. 1-25), 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 with one or more of the vascular access devices (100, 200, 300, 400), 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, 300, 400), 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, 300, 400) by a needleless connection.

[0030] Throughout the figures (FIGS. 4, 10, and 25), a cross section of a patient's skin 20 is shown. The outermost layer is the epidermal layer 22. Beneath the epidermal layer 22 is the dermal layer 24, which is in turn subcutaneous layer 26. Insulin is typically injected beneath the skin into the subcutaneous layer 26 to ensure rapid and uniform distribution of insulin throughout the patient's body. A needle cannula having a length of 6 mm can pass through the subcutaneous layer 26 and into the muscle layer (not shown), which is undesirable.

[0031] 1-4, vascular access device 100 comprises a cylindrical base 110 having a proximal end 112 that is removably attached to or integral with the distal end 76 of the syringe, and a distal end 114. An opening 142 extends through cylindrical base 110 configured to receive needle cannula 80.

[0032] The distal end 114 further comprises a flange 120 extending outward from the distal end 114 at a substantially right angle relative to the base 110 and is integral with the base 110. The flange 120 further comprises two prongs 130 extending distally from the flange 120, the two prongs 130 having distal ends 132 extending a length from the flange 120. The two prongs 130 are substantially perpendicular to the flange 120 and form a U-shape with the flange 120. In some embodiments, the flange 120 has a disc-shaped configuration, and in some embodiments, the flange has a triangular configuration. In embodiments in which the flange 120 has a disc-shaped configuration, the two prongs can be uniform collars surrounding the disc-shaped flange 120. In some embodiments, a rib 122 extends between the flange 120 and each of the two prongs 130. The rib 122 is configured to provide additional structural rigidity to the flange 120 and the prongs 130.

[0033] Vascular access device 100 further includes a distal protrusion 140 extending distally from flange 120, distal protrusion 140 having a distal surface 144. In some embodiments, distal protrusion 140 has a cylindrical body and has the same width as base 110. In some embodiments, as best shown in FIG. 3B, base 110 and distal protrusion 140 share a common central axis C. As best shown in FIG. 2A, base 110 and distal protrusion 140 share an opening 142 extending therethrough for receiving needle cannula 80. In some embodiments, needle cannula 80 is secured to distal end 76 of barrel 72 (as best shown in FIGS. 12 and 13B). When the vascular access device 100 is connected to the distal end 76 of the barrel, the needle cannula 80 extends from the distal end 76 of the barrel 72 through the distal surface 144 of the distal projection 140 of the vascular access device 100. In some embodiments, the needle cannula 80 extends a distance Dc from the distal surface 144 of the distal projection 140 of the vascular access device 100. In some embodiments, the distance Dc is sufficient to penetrate the rubber stopper 50 of the vial 40. As best shown in FIGS. 2A, 2B, 3A, and 3B, in some embodiments, the distance Dc is sufficient to penetrate the rubber stopper 50 of the vial 40 at an angle having a range of 90 degrees to 45 degrees relative to the rubber stopper 50 of the vial 40. In some embodiments, the distance Dc is 6 mm, which allows the needle cannula 80 to penetrate the rubber stopper 50 of the vial 40 at an angle ranging from 90 degrees to 45 degrees relative to the rubber stopper 50 of the vial when the vial 40 is a common or standard insulin vial.

[0034] 3B, the two prongs 130 are spaced apart from each other by a distance Dp. The distance Dp is greater than the width Wv (cross-section) of the rubber stopper 50 of the vial 40 so that the two prongs 130 can pass through the rubber stopper 50 of the vial 40. Because the two prongs 130 can pass over the rubber stopper 50 of the vial 40, the needle cannula 80 can be fully inserted into the rubber stopper 50 of the vial 40 until the distal surface 144 of the projection 140 abuts the top surface 52 of the rubber stopper 50, withdrawing the medication from the vial 40.

[0035] 2B illustrates that needle cannula 80 and vascular access device 100 may be inserted at a 45-degree angle, at which angle needle cannula 80 is in fluid communication with neck 44 of vial 40. FIG. 3B illustrates the range of motion of needle cannula 80 and vascular access device 100 behind needle cannula 80. In particular, needle cannula 80 and vascular access device 100 can access top surface 52 of rubber stopper 50 at angles ranging from 45 degrees to 135 degrees relative to top surface 52 of rubber stopper 50. For the entire range of angles from 45 degrees to 135 degrees relative to top surface 52 of rubber stopper 50, needle cannula 80 is in fluid communication with neck 44 of vial 40.

[0036] 3B shows needle cannula 80 and vascular access device 100 inserted into top surface 52 of rubber stopper 50 at a 90 degree angle relative to top surface 52 of rubber stopper 50. In FIG. 3B, distal surface 144 of protrusion 140 fully contacts top surface 52 of rubber stopper 50, and therefore the entire distance Dc of needle cannula 80 is inserted through top surface 52 of rubber stopper 50.

[0037] 4 shows the needle cannula 80 and vascular access device 100 partially inserted into the subcutaneous layer 26 of a patient's skin 20. As shown in FIG. 4 , the U-shape of the flange 120 and the two prongs 130 prevents the epidermal layer 22 from contacting the distal surface 144 of the projection 140, and therefore, the U-shape of the flange 120 and the two prongs 130 prevents the needle cannula 80 from being fully inserted into the patient's skin 20. Thus, the flange 120 and the two prongs 130 effectively limit the distance Dc of the needle cannula 80 as the vascular access device 100 is advanced against a flat surface, such as the patient's skin 20.

[0038] As shown in FIG. 4 , the two prongs 130 have a distance Df that extends beyond the distal surface 144 of the projection 140 by a distance Dn. Thus, the two prongs 130 are effective to limit the distance Dc that the needle cannula 80 fully penetrates the patient's skin 20 to only the distance Dn. In some embodiments in which the needle cannula 80 has a distance Dc of 6 mm, the distance Dn (the distance that the two prongs 130 extend beyond the distal surface 144 of the projection 140) is 2 mm, ensuring an effective needle cannula length Dn′ of 4 mm. In such a configuration, as shown in FIG. 4 , the needle cannula 80 can be inserted only 4 mm into the patient's skin 20 and, therefore, is inserted only into the subcutaneous layer 26. In other words, the two prongs 130 are configured as a hard stop to prevent further insertion of the needle cannula into the patient's skin 20. Additionally, the flange 120 and the two prongs 130 ensure the verticality of the needle cannula 80 while administering the medication (while inserting the needle cannula into the patient's skin 20).

[0039] A method of using the vascular access device 100 includes attaching the proximal end 112 of the base 110 of the vascular access device 100 to the distal end 76 of the syringe 70; inserting the needle cannula 80 into the top surface 52 of the rubber stopper 50 of the vial 40 until the distal surface 144 of the prong 140 abuts the top surface 52 of the rubber stopper 50; withdrawing the medication from the vial 40 by at least partially withdrawing the plunger rod 74 from the barrel 72 of the syringe 70; inserting the needle cannula 80 into the patient's skin 20 until the two prongs 130 abut the epidermal layer 22 of the patient's skin 20; and injecting the medication into the patient's skin 20 by at least partially advancing the plunger rod 74 into the barrel 72 of the syringe 70.

[0040] As shown in FIGS. 5-10 , a vascular access device 200 according to one or more embodiments includes a cylindrical base 210 having a proximal end 212 that is removably attached to or integral with the distal end 76 of the syringe, and a distal end 214. The distal end 214 further includes a flange 220 extending outwardly from the distal end 214. Each of the flanges 220 further includes a prong 230 extending distally from the flange 220. Each prong 230 has a distal end 232 that extends a certain length from the flange 220. In some embodiments, the distal end 232 is a flat surface. In some embodiments, each prong 230 is substantially perpendicular to the flange 220, forming a U-shape with the flange 220. In some embodiments, each prong 230 is at an acute angle to the flange 220, forming a U-shape with the flange 220.

[0041] As best shown in FIG. 6 , the flanges 220 are connected by a body 222 between the flanges 220. In some embodiments, the body 222 further comprises a cavity 224 for receiving a portion of the distal end 214 of the base 210. In some embodiments, the body 222 further comprises a connection point 226 for connecting to a pivot 216 located at the distal end 214 of the base 210. In some embodiments, the pivot 216 is a pair of tabs to which the connection point 226 connects. In some embodiments, the connection point 226 is an opening in the body 222 for receiving the pair of tabs of the pivot 216 of the base 210. In some embodiments, the base 210 and the body 222 of the flange 220 are two separate components that are snap-fit ​​together by the pivot 216 and the connection point 226. In some embodiments, the base 210 and the body 222 are a unitary structure with a living hinge to provide a range of motion for the body 222 of the flange 220 relative to the base 210. Both the pivot 216-connection point 226 and the living hinge have an angular range of motion shown in FIG. 6 as θ of 0 to 75 degrees.

[0042] Vascular access device 200 further includes a distal protrusion 240 extending distally from flange 220, distal protrusion 240 having a distal surface 244. In some embodiments, distal protrusion 240 has a cylindrical body and has the same width as base 210. In some embodiments, distal protrusion 240 has a width that is narrower than the width of cavity 224 in flange 220 such that distal protrusion 240 can extend beyond cavity 224, at least as shown in FIG.

[0043] As best shown in FIG. 10 , needle cannula 80 extends a distance Dc from distal surface 244 of distal projection 240 of vascular access device 100. In some embodiments, distance Dc is sufficient to penetrate rubber stopper 50 of vial 40. As best shown in FIGS. 8-10 , in some embodiments, distance Dc is sufficient to penetrate rubber stopper 50 of vial 40 at an angle ranging from 90 degrees to 45 degrees relative to rubber stopper 50 of vial 40 due to rotation of flange 220 about pivot 216. In some embodiments, distance Dc is 6 mm, which allows needle cannula 80 to penetrate rubber stopper 50 of vial 40 at an angle ranging from 90 degrees to 45 degrees relative to rubber stopper 50 of vial 40 when vial 40 is a common or standard insulin vial.

[0044] 9, the two prongs 230 are positioned at a distance Dp from each other. The distance Dp is greater than the width Wv of the rubber stopper 50 of the vial 40 so that the prongs 230 can pass through the rubber stopper 50 of the vial 40. Because the prongs 230 can pass over the rubber stopper 50 of the vial 40, the needle cannula 80 can be fully inserted into the rubber stopper 50 of the vial 40 until the distal surface 244 of the prongs 240 is adjacent the top surface 52 of the rubber stopper 50 to withdraw the medication from the vial 40.

[0045] 8 and 9 illustrate that the needle cannula 80 and vascular access device 200 can be inserted at a 45-degree angle, at which the needle cannula 80 is in fluid communication with the neck 44 of the vial 40. FIG. 9 illustrates the range of motion of the needle cannula 80 and the vascular access device 200 behind the needle cannula 80. In particular, the needle cannula 80 and vascular access device 200 can access the top surface 52 of the rubber stopper 50 at angles ranging from 45 degrees to 135 degrees relative to the top surface 52 of the rubber stopper 50. For the entire range of angles from 45 degrees to 135 degrees relative to the top surface 52 of the rubber stopper 50, the needle cannula 80 is in fluid communication with the neck 44 of the vial 40. In FIG. 9, the distal surface 244 of the protrusion 240 fully contacts the top surface 52 of the rubber stopper 50, and therefore the entire distance Dc of the needle cannula 80 is inserted through the top surface 52 of the rubber stopper 50.

[0046] 10 shows needle cannula 80 and vascular access device 200 partially inserted into subcutaneous layer 26 of a patient's skin 20. As shown in FIG. 10 , the U-shape of flange 220 prevents epidermal layer 22 from contacting distal surface 244 of prong 240, thereby preventing full insertion of needle cannula 80 into the patient's skin 20. Thus, flange 220 and prong 230 effectively limit distance Dc of needle cannula 80.

[0047] As shown in FIG. 10 , the prongs 230 have a distance Df that extends a distance Dn beyond the distal surface 244 of the projections 240. Thus, the prongs 230 are effective in limiting the distance Dc that the needle cannula 80 fully penetrates the patient's skin 20 to only the distance Dn. In some embodiments in which the needle cannula 80 has a distance Dc of 6 mm, the distance Dn (the distance the prongs 230 extend beyond the distal surface 244 of the projections 240) is 2 mm, ensuring an effective needle cannula length Dn′ of 4 mm. In such a configuration, as shown in FIG. 10 , the needle cannula 80 can be inserted only 4 mm into the patient's skin 20 and, therefore, only into the subcutaneous layer 26. In other words, the prongs 230 are configured as a hard stop to prevent further insertion of the needle cannula 80 into the patient's skin 20. Additionally, flange 220 and prongs 230 ensure the verticality of needle cannula 80 while administering medication (while inserting the needle cannula into the patient's skin 20).

[0048] 6 and 10, the vascular access device 200 further comprises a slide 260 that surrounds the base 210 and is advanceable both proximally and distally relative to the base 210. The slide 260 includes a distal end 262 that has a width greater than the cavity 224 of the flange 220. When the slide 260 is advanced distally, the distal end 262 of the slide 260 abuts the flange 220, causing the flange 220 to become perpendicular to the distal end 262 and the base 210. FIG. 6 illustrates a retracted position of the slide 260 in which the flange 220 is free to pivot, while FIG. 10 illustrates a fully advanced position of the slide 260 in which the distal end 262 of the slide 260 fully abuts the flange 220.

[0049] In embodiments without slide 260, flange 220 passively adjusts to be perpendicular to needle cannula 80 and base 110. In particular, if flange 220 is not perpendicular to needle cannula 80 and base 110 during insertion, the prong 230 distal to the other prongs 230 will contact the patient's skin first (due to the acute angle), resulting in rotation of flange 220 until the other prongs 230 contact the patient's skin. In other words, if flange 220 is not perpendicular to the skin, insertion of vascular access device 200 will adjust the entire flange 220 as the leading prong 230 contacts the patient's skin, so that flange 220 is perpendicular.

[0050] A method of using the vascular access device 200 includes attaching the proximal end 212 of the base 210 of the vascular access device 200 to the distal end 76 of the syringe 70; inserting the needle cannula 80 into the top surface 52 of the rubber stopper 50 of the vial 40 until the distal surface 244 of the prong 240 abuts the top surface 52 of the rubber stopper 50; withdrawing the medication from the vial 40 by at least partially withdrawing the plunger rod 74 from the barrel 72 of the syringe 70; inserting the needle cannula 80 into the patient's skin 20 until the prong 230 abuts the epidermal layer 22 of the patient's skin 20; and injecting the medication into the patient's skin 20 by at least partially advancing the plunger rod 74 into the barrel 72 of the syringe 70.

[0051] As shown in Figures 11-21B, a vascular access device 300 according to one or more embodiments comprises a cylindrical base 310 and a compressible foam tip 350. Figure 11 shows an assembled view of the vascular access device 300 on a syringe 70, and Figure 12 shows an exploded view of the vascular access device. As shown in Figures 11 and 12, in some embodiments, the vascular access device further includes a sterilization cap 390.

[0052] As shown in FIGS. 13A through 15B , base 310 has a cylindrical shape including proximal end 312 and distal end 314. Proximal end 312 includes a cavity 313 for receiving distal end 76 of syringe 70. An elongated tip 316 extends distally from distal end 314. Elongated tip 316 includes an opening 318 extending through elongated tip and base 310 for receiving needle cannula 80 (as best shown in FIGS. 13B and 14B ). Base 310 further includes a collar 320 extending from distal end 314, wherein collar 320 surrounds elongated tip 316 and opening 318. As shown in FIGS. 14A and 14B , collar 320 is spaced apart from elongated tip 316 such that a channel 322 is formed between collar 320 and elongated tip 316. In some embodiments, elongated tip 316 and collar 320 extend the same length and share a common distal surface 326. In some embodiments, base further comprises an adhesive channel 324 below distal end 314 of base and extending partially into channel 322. As described in further detail below, adhesive channel 324 can be filled with a medical-grade adhesive to permanently secure compressible foam tip 350 to base 310.

[0053] The compressible foam tip 350 has a substantially cylindrical shape. The compressible foam tip 350 has a distal portion 352 and a proximal portion 354, with the distal portion 352 having a diameter larger than the diameter of the proximal portion 354. The compressible foam tip 350 has a proximal end 356, a distal end 358, and a contact surface 360. The contact surface 360 ​​is formed by a proximal ridge of the distal portion 352 because the distal portion 352 has a diameter larger than the diameter of the proximal portion 354. The compressible foam tip 350 is hollow and has an opening 362 extending therethrough. In some embodiments, the distal end 358 is rounded.

[0054] As best shown in FIG. 13B , adhesive channel 324 is transverse to channel 322. Compressible foam tip 350 is inserted into and secured to base 310 until distal surface 326 of base 310 is adjacent contact surface 360 ​​of compressible foam tip 350 and proximal end 356 of compressible foam tip 350 is fully inserted into adhesive channel 324. As shown, proximal end 356 of compressible foam tip 350 has a width substantially equal to adhesive channel 324. Because adhesive channel 324 is transverse to channel 322, a cavity 364 is formed between elongated tip 316 of base 310 and proximal portion 354 of compressible foam tip 350. Cavity 364 can receive a sterilization cap 390.

[0055] As best shown in Figures 16 and 17, the distal portion 352 of the compressible foam tip 350 is compressible from an initial uncompressed length Lu in an initial uncompressed state to a final compressed length Lc in a final compressed state. The distal portion 352 compresses a length L from the uncompressed length Lu to the compressed length Lc by pressing the distal end 358 against a surface. In other words, pressing the distal portion 352 of the compressible foam tip 350 down against a surface compresses the distal portion 352 by a length L from the initial uncompressed length Lu to the final compressed length Lc. Releasing the distal portion 352 of the compressible foam tip 350 returns the distal portion 352 to the final uncompressed length Lu. Thus, the distal portion 352 of the compressible foam tip 350 has an initial uncompressed length Lu, a final compressed length Lc, and a final uncompressed length Lu.

[0056] As best shown in FIGS. 16 and 17 , the needle cannula 80 extends a distance Dc′ in the initial uncompressed state and in the final uncompressed state. When the compressible foam tip 350 is compressed to the final compressed state, the needle cannula 80 further extends a length L in addition to the distance Dc′. As shown in FIGS. 18 and 20B-20C , the compressible foam tip 350 is compressed by applying a compressive force against the top surface 52 of the rubber stopper 50 such that the needle cannula 80 is inserted into the top surface 52 of the rubber stopper 50 by the combined distance Dc′ and length L. As shown in FIGS. 19 and 20D , the compressible foam tip 350 can be abutted against the patient's skin 20 by advancing the syringe 70 against the patient's skin 20 with a force less than the compressive force such that the compressible foam tip 350 does not deform and only the distance Dc′ is advanced into the patient's skin 20. 16 and 17, in some embodiments where distance Dc' is 4 mm and length L is 2 mm, the effective needle length in the final compressed state is 6 mm (the combined length Dc' and length L). In such a configuration, needle cannula 80 can be inserted only 4 mm into the patient's skin 20, and therefore only into the subcutaneous layer 26, as shown in FIGS.

[0057] As shown in FIGS. 20A-20D, a method of using vascular access device 300 includes attaching proximal end 312 of base 310 of vascular access device 300 to distal end 76 of syringe 70; inserting needle cannula 80 into top surface 52 of rubber stopper 50 until distal end 358 of distal portion 352 of compressible foam tip 350 abuts top surface 52, as shown in FIG. 20B; and further compressing distal portion 352 against top surface 52 of rubber stopper 50 of vial 40 with a compressive force. 20D , and withdrawing the medication from the vial 40 by at least partially withdrawing the plunger rod 74 from the barrel 72 of the syringe 70; inserting the needle cannula 80 into the patient's skin 20 until the distal end 358 of the distal portion 352 of the compressible foam tip 350 abuts the top surface 52 of the rubber stopper 50 of the vial 40, as shown in FIG. 20D ; and injecting the medication into the patient's skin 20 by at least partially advancing the plunger rod 74 into the barrel 72 of the syringe 70.

[0058] 22-25, a vascular access device 400 according to one or more embodiments includes a cylindrical base 410 having a distal end shape 450 configured to limit the effective needle cannula length. The base 410 includes an opening 418 extending therethrough for receiving the needle cannula 80. As shown in FIGS. 11 and 12, in some embodiments, the vascular access device further includes a sterilization cap 490.

[0059] Base 410 has a cylindrical shape including proximal end 412 and distal end 414, with the distal end having a distal end shape 450 configured to limit the effective needle cannula length. As best shown in FIG. 25 , distal end shape 450 includes a beveled surface 452 and a distal flat surface 454 located distally of beveled surface 452. Beveled surface 452 is inclined at an angle θ relative to base 410. In some embodiments, angle θ is 45 degrees. In some embodiments, angle θ is between 30 and 60 degrees. In some embodiments, distal flat surface 454 includes a lateral extension 456.

[0060] As best shown in FIGS. 23 and 24, angled surface 452 is configured to allow needle cannula 80 to be advanced at either an angle θ or a right angle relative to top surface 52 of rubber stopper 50 .

[0061] As best shown in FIG. 25 , needle cannula 80 extends a distance Dc from beveled surface 452 at opening 418, with distal flat surface 454 located a distance Dn from opening 418. When vascular access device 400 is inserted into a patient's skin 20, distal flat surface 454 can prevent the needle cannula from being fully inserted, particularly when vascular access device 400 is inserted until distal flat surface 454 abuts epidermal layer 22, as shown in FIG. 25 . In some embodiments, where distance Dc is 6 mm, distance Dn is 2 mm, and thus needle cannula 80 can be inserted only 4 mm. In some embodiments, distance Dc is 6 mm so that needle cannula 80 can penetrate rubber stopper 50 of vial 40 at angles ranging from 90 degrees to 45 degrees relative to rubber stopper 50 of vial 40 when vial 40 is a common or standard insulin vial.

[0062] 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 antiseptic 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.

[0063] 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.

[0064] 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.

[0065] 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 apparatus 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 distal end having an elongated tip and a collar extending therefrom, the collar surrounding the elongated tip, the elongated tip having an opening extending from the proximal end of the base to the elongated tip, the collar being spaced a distance from the elongated tip, a channel being formed between the collar and the elongated tip, the channel having a distal surface; a compressible foam tip having proximal and distal ends and a proximal and distal portion, the distal portion having a diameter greater than a diameter of the proximal portion forming a contact surface, the compressible foam tip being inserted into and secured to the base, the distal surface of the base abutting the contact surface of the compressible foam tip, the distal portion of the compressible foam tip being compressible from an initial uncompressed length Lu in an initial uncompressed state to a final compressed length Lc in a final compressed state; a needle cannula extending through the opening, the needle cannula extending a distance Dc' from the distal portion in the uncompressed state; Including, the needle cannula further extends a length L in addition to the distance Dc' upon compressing the compressible foam tip to the final compressed state; Vascular access devices.

2. 10. The device of claim 1, wherein the proximal end of the cylindrical base is removably attached to or integral with the distal end of a syringe barrel.

3. The device of claim 2 , wherein the needle cannula is attached to the distal end of the barrel and extends from the distal end of the syringe barrel through the opening.

4. The device of claim 1 , wherein the elongate tip and collar extend the same length and share the distal surface.

5. The device of claim 1 , wherein the base further includes an adhesive channel beneath the distal end of the base and at least partially within the channel, the adhesive channel being transverse to the channel.

6. 6. The device of claim 5, wherein the proximal end of the compressible foam tip is inserted into the adhesive channel, the proximal end of the compressible foam tip having a width substantially equal to the adhesive channel, and a cavity is formed between the elongated tip of the base and the proximal portion of the compressible foam tip.

7. 2. The device of claim 1, wherein the compressible foam tip is compressed by applying a compressive force against the top surface of the rubber stopper such that the needle cannula is inserted into the top surface of the rubber stopper a combined distance Dc' and length L.

8. The device of claim 1 , wherein the distance Dc′ is 4 mm.

9. 8. The device of claim 7, wherein the combined length of the distance Dc' and the length L is 6 mm.

10. 1. A vascular access device comprising: a cylindrical base having a proximal end and a distal end, the distal end including a distal end feature, the base including an opening extending therethrough, the distal end feature having an inclined surface and a distal flat surface disposed distally relative to the inclined surface, the inclined surface being inclined at an angle θ relative to the base, the distal flat surface being disposed a distance Dn from the opening; a needle cannula extending through the opening, the needle cannula extending a distance Dc from the beveled surface at the opening; Including, Vascular access devices.

11. The device of claim 10 , wherein the distal planar surface includes a lateral extension.

12. 11. The device of claim 10, wherein the distance Dc is 6 mm, the distance Dn is 2 mm, and the needle cannula has an effective length of 4 mm.

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