Syringe attachment
The single, integrated syringe attachment solves the problem of inaccurate injection depth and angle, providing stable control and improved ergonomics, reducing user errors and material waste.
Patent Information
- Application Number
- CN202480064369.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-08-07
- Filing Date
- 2024-08-05
- Publication Date
- 2026-05-05
AI Technical Summary
Existing syringes and syringe accessories cannot solve the problem of inaccurate injection depth and angle in a simple and straightforward manner, which leads to a high possibility of user error, patient injury, material waste, and increased nursing time.
A single, integral syringe accessory is provided, comprising a tubular portion, a flange, and a base portion, which limits the depth of needle protrusion and provides a stable contact angle, improving ergonomics.
It achieves stable depth and angle control of the syringe, reduces user errors, improves the user experience, and reduces material waste and care time.
Smart Images

Figure CN121985973A_ABST
Abstract
Description
[0001] Cross-references to related applications This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 518,097, the contents of which are incorporated herein by reference. Technical Field
[0002] This disclosure generally relates to syringe accessories, and more specifically to syringe accessories comprising a single integral body and methods of using the syringe accessory with a syringe for injection. Background Technology
[0003] Various devices and methods are used to deliver medications (such as active pharmaceutical ingredients (APIs)) to patients. For example, APIs can be injected using a syringe or autoinjector, orally ingested / consumed, or inhaled. Syringes can be used to deliver APIs in fluid form directly to the intended injection site (e.g., bloodstream) with maximum efficacy. Furthermore, different APIs require injection at different depths through the skin to achieve maximum potency, such as intravenous, intramuscular, subcutaneous, and intradermal. In some cases, different APIs may also require injection at specific angles; for example, intramuscular injection may be avoided if the intended site is subcutaneous. Several types of syringes with varying complexities exist. For example, syringes may be pre-filled, may include needle safety features, and may vary in the number of components (e.g., barrel, plunger rod, needle, and optional plunger stop), etc. In clinical studies, conventional manual syringes are typically used for manual injection of medications. Summary of the Invention
[0004] This document describes syringe accessories and methods of using syringe accessories with syringes for injection. Syringe accessories can be attached to a syringe or incorporated into the syringe device itself to limit the injection depth of the syringe, provide stable contact with the skin surface, and improve the ergonomics of syringe use. A syringe accessory may include a single integral housing comprising a tubular portion, one or more flanges located at a proximal end of the tubular portion, and a base portion located at a distal end. When the syringe is inserted into the syringe accessory described herein, the protrusion of the needle from the base of the syringe accessory can be limited to the desired injection depth. The base portion provides a stable contact angle for injection onto the user's skin. The use of the syringe is improved and simplified due to the larger flanges at the ends of the syringe accessory described herein.
[0005] As mentioned above, the most common method (e.g., at least in clinical studies) is to manually inject APIs using low-cost, conventional manual syringes. While conventional syringes are simple in design and function, they have a high potential for user error. For example, without extensive experience, it can be difficult to determine the appropriate injection depth and / or angle for a particular type of injection using a conventional syringe. Incorrect injections require repeated attempts to achieve the correct result, which can lead to patient injury or pain, waste of materials (e.g., not only the syringe but also the syringe contents (API) and syringe packaging), and increased patient care time. Furthermore, variations in injection angle, injection depth, and / or skin contact effects during syringe use in clinical trials can lead to inaccurate results. Finally, conventional manual syringes may have minimal ergonomic features, which in turn makes them difficult for users to use easily.
[0006] Existing syringes and / or syringe accessories (e.g., attachments) have attempted to address one or more of these problems; however, in addition to failing to comprehensively resolve each of the aforementioned shortcomings of syringes, existing syringes and / or syringe accessories typically comprise multiple parts and are compatible with only one or a limited number of syringe types. Therefore, a gap remains in the field of devices such as syringes or syringe accessories where all these problems can be solved in a concise and simple manner.
[0007] The syringe accessories described herein can be used to alleviate difficulties associated with syringes, whether they are conventional manual syringes as described herein, more complex variations thereof, or syringe attachments that attempt to solve one or more of the aforementioned problems. The syringe accessories described herein may include a single, integral housing into which the syringe can be easily inserted for injection. The single, integral housing may include one or more flanges located at the distal end of a tubular portion of the housing, which improve ergonomics and ease of use for the user. The housing may also include a base portion extending outward from the tubular portion of the housing in at least one direction to provide a stable contact surface at the injection site. Finally, when inserted into the single, integral housing, protrusion of the needle from the syringe can be restricted, thereby providing a consistent injection depth.
[0008] In some embodiments, a syringe accessory is provided comprising: a single integral housing including: a tubular portion configured to receive a syringe barrel; one or more flanges located at a proximal end of the tubular portion; and a base portion located at a distal end of the tubular portion, the base portion extending outwardly from an outer surface of the tubular portion toward an end of the base portion in at least one direction, the end of the base portion being configured to provide a stable contact surface at an injection site, wherein the single integral housing is configured to restrict the protrusion of the syringe needle when the syringe barrel is received in the tubular portion.
[0009] In some embodiments, a method of assembling a syringe and a syringe accessory is provided, the method comprising: inserting a syringe barrel into a proximal end of a tubular portion of a syringe accessory; and advancing the barrel toward a distal end of the tubular portion until one or more flanges of the syringe are clamped onto one or more latches on an inner surface of the syringe accessory, wherein the syringe accessory includes a single integral housing comprising: a tubular portion; one or more flanges located at the proximal end of the tubular portion; and a base portion located at the distal end of the tubular portion, the base portion extending outwardly from an outer surface of the tubular portion toward an end of the base portion in at least one direction to provide a stable contact surface at the injection site.
[0010] In some embodiments, a method of injecting an active pharmaceutical ingredient (API) contained in a syringe is provided, the method comprising: inserting a needle of the syringe into an injection site, the syringe being disposed in a single integral housing including: a tubular portion receiving a barrel of the syringe; one or more flanges located at a proximal end of the tubular portion; and a base portion located at a distal end of the tubular portion, the base portion extending outwardly from an outer surface of the tubular portion toward an end of the base portion in at least one direction to provide a stable contact surface at the injection site; and injecting the API at the injection site at a depth of the needle limited by the single integral housing.
[0011] In some embodiments, a syringe includes: a plunger including a plunger stop at a distal end of the plunger and a plunger rod extending from the plunger stop; and a single integral housing including: a barrel configured to receive the plunger rod; one or more flanges located at a proximal end of the barrel; and a base portion located at a distal end of the barrel, the base portion extending outward from an outer surface of the barrel toward an end of the base portion in at least one direction, the end of the base portion being configured to provide a stable contact surface at an injection site, wherein the single integral housing is configured to limit needle protrusion when a needle is engaged with the distal end of the barrel.
[0012] In some embodiments, a method of injecting an active pharmaceutical ingredient (API) contained in a syringe is provided, the method comprising: inserting a needle of the syringe into an injection site, the syringe comprising: a plunger including a plunger stop at a distal end of the plunger and a plunger rod extending from the plunger stop; and a single integral housing comprising: a barrel receiving the plunger rod; one or more flanges at a proximal end of the barrel; and a base portion at a distal end of the barrel, the base portion extending outward from an outer surface of the barrel toward an end of the base portion in at least one direction, the end of the base portion providing a stable contact surface at the injection site; and injecting the API at the injection site at a depth of the needle limited by the single integral housing. Attached Figure Description
[0013] Various aspects of the disclosed system and method are specifically described in the appended claims. The features and advantages of the disclosed system and method will be better understood by referring to the detailed description of exemplary embodiments and the accompanying drawings.
[0014] Figure 1A A perspective view of a first exemplary syringe accessory according to some embodiments is shown.
[0015] Figure 1B A front view of a first exemplary syringe accessory according to some implementations is shown.
[0016] Figure 1C A cross-sectional perspective view of a first exemplary syringe accessory according to some embodiments is shown.
[0017] Figure 1D A side view of a first exemplary syringe accessory according to some embodiments is shown.
[0018] Figure 1E A bottom view of a first exemplary syringe accessory according to some embodiments is shown.
[0019] Figure 1F A top view of a first exemplary syringe accessory according to some embodiments is shown.
[0020] Figure 1G A partial perspective view of a first exemplary syringe accessory according to some embodiments is shown.
[0021] Figure 2A A perspective view of a second exemplary syringe accessory according to some embodiments is shown.
[0022] Figure 2B A front view of a second exemplary syringe accessory according to some implementations is shown.
[0023] Figure 2C A cross-sectional perspective view of a second exemplary syringe accessory according to some embodiments is shown.
[0024] Figure 2D A side view of a second exemplary syringe accessory according to some embodiments is shown.
[0025] Figure 2E A bottom view of a second exemplary syringe accessory according to some embodiments is shown.
[0026] Figure 2F A top view of a second exemplary syringe accessory according to some embodiments is shown.
[0027] Figure 2G A partial perspective view of a second exemplary syringe accessory according to some embodiments is shown.
[0028] Figure 3A A perspective view illustrating a first exemplary syringe accessory and syringe assembly according to some embodiments is shown.
[0029] Figure 3B A perspective view illustrating a second exemplary syringe accessory and syringe assembly according to some embodiments is shown.
[0030] Figure 4A A perspective view of a first exemplary syringe accessory and syringe assembly relative to an injection site is illustrated according to some embodiments.
[0031] Figure 4B A perspective view of a second exemplary syringe accessory and syringe assembly relative to an injection site is illustrated according to some embodiments.
[0032] Figure 5AA perspective view of an exemplary syringe accessory according to some embodiments is shown, the syringe accessory including a locking member disposed at the proximal end of a tubular portion within one or more flanges of the syringe accessory to retain the syringe within the syringe accessory.
[0033] Figure 5B Examples are given based on some implementation schemes. Figure 5A A perspective view of a syringe accessory having a syringe disposed therein.
[0034] Figure 5C Examples are given based on some implementation schemes. Figures 5A to 5B A top view of the syringe accessory.
[0035] Figure 5D Examples are given based on some implementation schemes. Figures 5A to 5C A partial side view of the syringe accessory.
[0036] Figure 6A An exemplary syringe accessory according to some embodiments is illustrated in perspective view, the syringe accessory including an opening extending the length of a tubular portion of the syringe accessory and one or more retaining portions positioned relative to the opening to retain the syringe within the syringe accessory.
[0037] Figure 6B Examples are given based on some implementation schemes. Figure 6A A perspective view of a syringe accessory having a syringe disposed therein.
[0038] Figure 7A A perspective view of an exemplary syringe accessory according to some embodiments is shown, the syringe accessory including a gate extending the length of a tubular portion of the syringe for receiving and removing the syringe from within the syringe accessory.
[0039] Figure 7B Examples are given based on some implementation schemes. Figure 7A A perspective view of an exemplary syringe accessory having a syringe disposed therein.
[0040] Figure 8A A perspective view of an exemplary syringe accessory according to some embodiments is shown, the syringe accessory including an opening extending the length of a tubular portion and a base portion of the syringe accessory, and one or more retaining portions disposed relative to the opening to retain the syringe within the syringe accessory.
[0041] Figure 8B Examples are given based on some implementation schemes. Figure 8A A perspective view of an exemplary syringe accessory having a syringe disposed therein.
[0042] Figure 8C Examples are given based on some implementation schemes. Figure 8A A perspective view of the base portion of an exemplary syringe accessory.
[0043] Figure 8D Examples are given based on some implementation schemes. Figure 8C A cross-sectional view of the base portion.
[0044] Figure 9A A perspective view of an exemplary syringe accessory according to some embodiments is shown, the syringe accessory including an opening extending the length of a tubular portion and a base portion of the syringe accessory, and a door extending a portion of the length of the opening to retain the syringe within the syringe accessory.
[0045] Figure 9B Examples are given based on some implementation schemes. Figure 9A A perspective view of a syringe accessory having a syringe disposed therein.
[0046] Figure 9C Examples are given based on some implementation schemes. Figure 9A A perspective view of the base portion of an exemplary syringe accessory.
[0047] Figure 9D Examples are given based on some implementation schemes. Figure 9C A cross-sectional view of the base portion.
[0048] Figure 10A A perspective view of the base portion of an exemplary syringe accessory according to some embodiments is shown, the base portion including a convex surface for contacting the surface of a patient's skin.
[0049] Figure 10B Examples are given based on some implementation schemes. Figure 10A A cross-sectional view of the base portion.
[0050] Figure 11A A perspective view of a base portion of an exemplary syringe accessory according to some embodiments is shown, the base portion including a convex surface for contacting a patient's skin surface, the base portion including one or more openings separated by one or more ribs along the convex surface of the base portion.
[0051] Figure 11B Examples are given based on some implementation schemes. Figure 11A A cross-sectional view of the base portion.
[0052] Figure 12A A perspective view of a base portion of an exemplary syringe accessory according to some embodiments is shown, the base portion including an outer portion and an inner portion extending distal to the outer portion.
[0053] Figure 12B Examples are given based on some implementation schemes. Figure 12A A cross-sectional view of the base portion.
[0054] Figure 13A A perspective view of a base portion of an exemplary syringe accessory according to some embodiments is shown, the base portion including an outer portion and an inner portion aligned at a distal end of the base portion.
[0055] Figure 13B Examples are given based on some implementation schemes. Figure 13A A cross-sectional view of the base portion.
[0056] Figure 14A A perspective view of the base portion of an exemplary syringe accessory according to some embodiments is shown, the base portion including an outer portion extending outward in at least one direction.
[0057] Figure 14B Examples are given based on some implementation schemes. Figure 14A A cross-sectional view of the base portion.
[0058] Figure 15A A perspective view of a base portion of an exemplary syringe accessory according to some embodiments is shown, the base portion including an outer portion extending inward in at least one direction.
[0059] Figure 15B Examples are given based on some implementation schemes. Figure 15A A cross-sectional view of the base portion.
[0060] Figure 16 A perspective view of a portion of a tubular portion of a syringe accessory according to some embodiments is shown, the tubular portion including a finger pad disposed along the length of the tubular portion. Detailed Implementation
[0061] This document describes syringe accessories and methods for using syringe accessories with syringes for injection. Syringe accessories are attached to syringes and can provide several advantages to the user of the syringe. These advantages may include: 1) limiting the injection depth of the needle, 2) providing stable contact with the user's skin, and 3) improving the user's grip on the syringe. Syringe accessories may include a housing comprising a tubular portion, one or more flanges located at a proximal end of the tubular portion, and a base portion located at a distal end of the tubular portion. The housing may be formed from a single, integral piece of material. The housing can limit the protrusion of the syringe needle extending from the base portion of the housing to only the amount necessary to provide the desired injection depth. Therefore, when properly inserted into the tubular portion of the integral housing, the syringe can achieve the desired injection depth at the injection site. The base portion of the single, integral housing can also provide a stable injection angle at the injection site. For example, the base portion may extend outward from the outer surface of the tubular portion of the housing toward the end of the base portion in at least one direction, and the end of the base portion is configured to contact the skin surface at the injection site, which can provide a stable injection angle (e.g., an injection angle of about 90° relative to the skin surface).
[0062] The syringe accessories described herein are adaptable for use with syringes of varying complexity and for a wide range of intended uses. For example, they can be used with conventional manual syringes, which are commonly used in clinical trials of drugs, at least due to their availability and affordability. Furthermore, they can be used with needles intended for intravenous, intramuscular, subcutaneous, and / or intradermal injections. Therefore, the syringe accessories described herein can mitigate one or more disadvantages of syringes to improve the outcomes of syringe use and the user experience. In cases where the syringe accessories described herein accommodate syringes used in clinical studies, they can mitigate any potential variations in outcomes, at least due to inconsistent syringe use.
[0063] The syringe accessories described herein can provide consistent desired injection depth and angle, and can improve the ergonomics of the device within a single, simple housing. The syringe accessories can be used with syringes and / or needles that include needle safety features, and in some cases, may additionally or alternatively include needle safety features themselves. In some cases, the syringe accessories described herein can be reasonably embodied in the syringe and / or needle itself, which is understood to be within the scope of the disclosure provided herein. Implementing each of the aforementioned features in a single, simple, monolithic device is a challenge that existing syringes and / or syringe accessories have not yet adequately met.
[0064] As used herein, syringes may include hypodermic syringes, pre-filled syringes, glass syringes, plastic syringes, etc. Syringes may include a barrel, a plunger rod, and in some embodiments include a plunger stop. Syringes may be configured to attach to a variety of needles, the range of which is not intended to be limited to the disclosure provided herein. In some embodiments, the syringes, needles, and / or syringe accessories described herein may include one or more needle safety features, such as retractable needle features, pivoting needle caps, etc. Those skilled in the art will be able to reasonably apply the syringe accessories disclosed herein to a variety of injection devices, including various syringes, injectors, needles, etc.
[0065] As used herein, active pharmaceutical ingredients (APIs) can include pharmaceutical products, preparations, antibiotics, vaccines, drugs, etc. Exemplary APIs may include recombinant antibiotics, injectable formulations, and other large molecule drugs in liquid form (e.g., Nipocalimab). The list of APIs provided above is not intended to be exhaustive and can be extended to any pharmaceutical products, preparations, antibiotics, vaccines, etc., not explicitly stated herein.
[0066] As used herein, the proximal and distal portions or ends of the casing (or the tubular portion of the casing) are understood to be defined relative to the user of the syringe. For example, the proximal portion or end of the casing is the part / end closest to the user's hand holding the syringe. Conversely, the distal portion or end of the casing (or the tubular portion of the casing) is the part / end furthest from the user's hand holding the syringe. In other words, the distal portion / end would be the end of the syringe, which is understood to be attached to (or configured to be attached to) a needle that will then be injected into the patient.
[0067] In some embodiments, the syringe accessory described herein may be provided pre-attached to the syringe. That is, the syringe may be provided to be housed within the syringe accessory described herein. In some embodiments, the user may need to insert the syringe into the syringe accessory before administering an injection with the syringe. The syringe accessory and the syringe may be securely attached such that, once assembled, the syringe (e.g., syringe barrel) and the housing of the syringe accessory will not translate relative to each other.
[0068] In some embodiments, the syringe accessory may be single-use and disposable. In some embodiments, the syringe accessory may be sterilizable and therefore reusable. In some embodiments, the syringe may be pre-filled with API. Alternatively, the user may need to fill the syringe with API before using the syringe and associated syringe accessory.
[0069] As will be described in more detail below, it should be understood that the features of the syringe accessories described herein can be incorporated into a syringe device. That is, instead of providing separate syringes and syringe accessories, a single device can be provided that includes the features of a conventional syringe and the features of the syringe accessories described herein.
[0070] The syringe accessory provided herein will now first be described as a stand-alone device with reference to two exemplary embodiments. Then, components including the syringe accessory and the syringe, methods for using the syringe with the syringe accessory, and methods for assembling the syringe and the syringe accessory will be described. Next, an exemplary syringe device including the syringe accessory features described herein and its method of use will be described.
[0071] Syringe accessories Figures 1A to 1G Various views of a syringe accessory according to a first embodiment are illustrated, the syringe accessory including a single integral housing 100. The single integral housing 100 (hereinafter referred to as housing 100 for simplicity) may include a tubular portion 102 configured to receive a syringe barrel, one or more flanges 104 located at a proximal end of the tubular portion 102, and a base portion 106 located at a distal end of the tubular portion 102. As shown, the base portion 106 may extend outwardly from the outer surface of the tubular portion 102 toward its end in at least one direction.
[0072] In some embodiments, the tubular portion 102 may be configured to receive syringe cartridges, such as those with a volume capacity between 0.1 mL and 70 mL. For example, the tubular portion 102 may be configured to receive syringe cartridges with a volume capacity of 3 mL or 5 mL, wherein each syringe cartridge is respectively... Figure 3A and Figure 3B As shown in the figure. In some embodiments, the tubular portion 102 may be configured to receive a syringe barrel having a volumetric capacity of 0.1 mL, 0.25 mL, 0.3 mL, 0.5 mL, 1 mL, 2.5 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, 45 mL, 50 mL, 60 mL, 70 mL, or other volumes thereof, and is not explicitly stated.
[0073] In some embodiments, the shape of the housing 100 (e.g., the tubular portion 102) can be taken into account the shape and / or size of the syringe to which the housing is configured to receive. For example, the dimensions of at least the internal structure of the tubular portion 102 can be designed to accommodate the syringe barrel. In other words, the dimensions (e.g., length, width, etc.) of at least the internal structure of the tubular portion 102 can depend at least on the syringe to which the housing 100 is configured to receive. The external structure of the tubular portion 102 can mimic this structure, such as... Figures 1A to 1G As shown. For example, housing 100 (e.g., tubular portion 102) may include a uniform wall structure along the length of tubular portion 102. The wall thickness of housing 100 (more specifically, at least the wall thickness of tubular portion 102) may be about 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm, 2.25 mm, 2.5 mm, 2.75 mm, or 3 mm, or other volumetric values in between, and is not explicitly stated.
[0074] Alternatively, in some embodiments, the external structure of the housing 100 may include various shapes, for example, to improve ergonomics and / or allow visualization of the syringe (e.g., visualization of APIs in the syringe and / or markings on the syringe). For example, the external structure of at least the tubular portion 102 of the housing 100 may include an integral rectangular, circular, oval, or other body formed around the internal structure of the tubular portion 102, the body including a hollow receptacle configured to receive the syringe.
[0075] As shown, the tubular portion 102 may include a constriction portion 108. The constriction portion 108 can substantially distinguish the proximal portion of the tubular portion 102 from the distal portion of the tubular portion 102. In some embodiments, the constriction portion may be located substantially only within the internal structure of the tubular portion 102. When a syringe is inserted into the housing 100, the syringe barrel can be advanced through the tubular portion 102 until the end of the syringe barrel encounters the constriction portion 108 (e.g., the end of the proximal portion of the tubular portion 102). Therefore, the constriction portion 108 can restrict the advancement of the syringe through the housing 100 such that substantially all of the syringe barrel is located proximal to the constriction portion 108 (e.g., in the proximal portion of the tubular portion 102), and substantially all of the syringe needle is located distal to the constriction portion 108 (e.g., in the distal portion of the tubular portion 102). Furthermore, the constriction portion 108 can restrict the protrusion of the needle beyond the distal portion (and base portion 106) of the tubular portion 102. When the syringe barrel is inserted into the proximal portion of the tubular portion 102, the distal portion of the tubular portion 102 can shield at least a portion of the syringe needle. Alternatively or additionally, the tubular portion 102 (e.g., the distal portion of the tubular portion 102) can be configured to receive shielding (e.g., shielding with a removable cap, such as at least in...). Figures 3A to 3B The syringe needle shown in the image.
[0076] As described herein, the base portion 106 may extend outward from the outer surface of the tubular portion 102 toward its end. In some embodiments, the base portion 106 may extend outward from the outer surface of the tubular portion 102 in one, two, three, four, five, six or more directions. Figures 1A to 1GAn example is shown that includes a base portion 106 in a trumpet or conical shape. In other words, as... Figures 1A to 1G The base portion 106 shown may extend uniformly outward from the outer surface of the tubular portion 102. In some embodiments, the base portion 106 may additionally or alternatively extend vertically (e.g., along a longitudinal axis concentric with the tubular portion 102) outward from the end of the tubular portion 102 toward the end of the base portion 106. Figure 1G An embodiment is illustrated in which the base portion 106 includes an outer portion 114 extending circumferentially outward from the outer surface of the tubular portion 102 toward an end of the base portion 106, and an inner portion 116 extending vertically outward from the end of the tubular portion 102 toward an end of the base portion 106. Each of the outer portion 114 and the inner portion 116 of the base portion 106 may extend to intersect a plane (e.g., the XZ plane) substantially orthogonal to the longitudinal axis of the housing 100. In some embodiments, one of the outer portion 114 and the inner portion 116 of the base portion 106 may not extend fully into the XZ plane, such that only one of the outer portion 114 or the inner portion 116 may contact the injection site during use of the syringe accessory with the syringe. For example, the outer portion 114 may be configured to contact the injection site, while the inner portion 116 may not contact the injection site. In this configuration, the inner portion 116 may extend from the distal end of the base portion 106 by approximately 20%, 25%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 90%, or 95% of the distance the outer portion 114 extends along the Y-axis from the distal end of the base portion 106. In some embodiments, the portion of the base portion 106 located between the outer portions 114 and 116 may be hollow (e.g., as at least in...). Figure 1G (as shown), partially solid or solid.
[0077] In some embodiments, the base portion 106 may additionally or alternatively include one or more "legs" that extend individually from the outer surface of the tubular portion 102 toward the end of the base portion 106 at an angle to provide a stable contact surface at the injection site. For example, the base portion 106 may include two legs extending from the tubular portion 102 in opposite directions (e.g., along the X-axis or Z-axis), three legs extending outward to form a tripod base, four legs (e.g., two legs in the X-direction and two legs in the Z-direction), etc. One or more legs may extend from the outer surface of the tubular portion 102 toward the end of the base portion 106 at an angle, such as 20°, 30°, 45°, 60°, 70°, or less than 90° relative to the central longitudinal axis of the tubular portion 102.
[0078] The two-dimensional surface profile of the base portion 106 (e.g., a profile in the XY plane, YZ plane, and / or any plane therebetween) may include arcs, lines, or other types of curves. In some embodiments, the profile may include a first curve (e.g., a line, arc, etc.) having a first curvature, a second curve (e.g., a line, arc, etc.) having a second (different) curvature, etc. For example, Figure 1B and Figure 1D The outline of the base portion 106 in each of the XY and YZ planes is illustrated, wherein the outline comprises continuous arcs. However, the outline of the base portion 106 may additionally or alternatively include straight (or substantially straight) lines, or a combination of arcs and lines.
[0079] Because the housing 100 is configured to receive a syringe (e.g., the barrel of a syringe) extending through the tubular portion 102 and beyond the end of the base portion 106, it should be understood that the base portion 106 includes an opening (e.g., a through-hole) for receiving the syringe (e.g., the needle of the syringe, or, in some embodiments, the shielding needle of the syringe). The size of the opening in the base portion 106 can be designed such that at least the needle or shielding needle can be inserted through the base portion 106. The cross-section of the opening in the base portion 106 can be circular, oval, triangular, hexagonal, octagonal, square, rectangular, or another polygonal shape. In cases where the base portion 106 includes an outer segment 114 and an inner segment 116, the cross-section of the opening in the base portion 106 can differ from the overall cross-section of the base portion 106. For example, the overall cross-section of the base portion 106 can be circular, oval, triangular, hexagonal, octagonal, square, rectangular, or another polygonal shape. In some embodiments, the width of the cross-section (e.g., the width extending from a first point on the inner surface of the base portion 106 to a second point on the inner surface of the base portion 106 opposite the first point and within the same cross-section) can be between about 10 mm and 40 mm. For example, the width can be greater than or equal to 10 mm, 15 mm, 20 mm, 25 mm, or 30 mm. In some embodiments, the width can be less than or equal to 40 mm, 35 mm, 30 mm, 25 mm, 20 mm, or 15 mm. When the cross-sectional shape of the base portion 106 is circular, the width can be the diameter of the circular cross-section. When the base portion 106 includes an outer portion 114 and an inner portion 116, the respective widths of the inner portion 114 and the outer portion 116, as defined herein, can be within the aforementioned width range.
[0080] At least one cross-sectional dimension of the base portion 106 may be larger than the cross-sectional dimension of the tubular portion 102. For example, in at least Figure 1A and Figure 1CThe dimensions measured in the XZ plane shown can be larger in the base portion 106 than in the tubular portion 102. For example, in Figures 1A to 1G In the syringe accessory shown, from the central axis of the housing 100 (e.g., Figures 1A to 1D The radial dimension of the cross-section extending toward the outer surface of the housing 100 (shown as Y-axis) may be larger in the base portion 106 than in the tubular portion 102. In another example, the cross-sectional width measured from a first point on the outer surface to a second point on the outer surface opposite to the first point (and within the same cross-sectional plane) may be larger in the base portion 106 than in the tubular portion 102. When the base portion 106 includes an outer portion 114 and an inner portion 116, at least the aforementioned cross-sectional dimension of the outer portion 114 of the base portion 106 may be larger in the base portion 106 than in the tubular portion 102. In some embodiments, the aforementioned cross-sectional dimension of the inner portion 116 of the base portion 106 may be substantially the same as the cross-sectional dimension of the tubular portion 102 (e.g., the inner portion 116 may be an extension of the distal portion of the tubular portion 102). In some embodiments, the cross-sectional dimension of the inner portion 116 may be smaller or larger than the cross-sectional dimension of the tubular portion 102.
[0081] The aforementioned cross-sectional dimensions of the base portion 106 can increase (e.g., linearly, parabolically, etc.) as it extends outward from the outer surface of the tubular portion 102 toward the end of the base portion 106. Therefore, the cross-sectional dimension of the end of the base portion 106 can be the largest cross-sectional dimension (e.g., radius, diameter, width, etc.), at least the largest cross-sectional dimension among the tubular portion 102 and the base portion 106 of the housing 100. For example, the cross-sectional dimension of the end of the base portion 106 can be approximately 1.25 times, 1.5 times, 1.75 times, 2 times, 2.5 times, 3 times, or more times the cross-sectional dimension of the tubular portion 102.
[0082] The end of the base portion 106 may include a surface substantially orthogonal to the central axis of the housing 100 (e.g., the Y-axis shown), which is configured to provide a stabilizing surface at the injection site. The shape of this surface may depend on the shape of the cross-section of the base portion 106 described above. In some embodiments, the size (e.g., surface area) of this surface may depend on the size of the opening extending through the base portion 106, also as described above. In cases where the base portion 106 includes an outer portion 114 and an inner portion 116, the size of this surface may depend on one or more characteristics of the outer portion 114 and / or the inner portion 116. For example, as explained herein, the bottom surface of the base portion 106 may include the bottom surface of each of the outer portion 114 and the inner portion 116 of the base portion 106. However, in some embodiments, the surface of the base portion 106 may include only the surface of the outer portion 114, or alternatively, the surface of the inner portion 116, such that one of the outer portion 114 or the inner portion 116 of the base portion 106 is configured to contact the injection site.
[0083] In some embodiments, the width of the bottom surface of the base portion 106 (e.g., extending between a first point on the bottom surface and a second point on the bottom surface opposite the first point) can be between 20 mm and 40 mm. For example, the width of the bottom surface of the base portion 106 can be greater than or equal to 20 mm, 22 mm, 24 mm, 26 mm, 28 mm, or 30 mm. In some embodiments, the width of the bottom surface of the base portion 106 can be less than or equal to 40 mm, 38 mm, 36 mm, 34 mm, 32 mm, or 30 mm. Where at least the bottom surface of the base portion 106 comprises a circular shape, the width can be understood as the diameter of the circular bottom surface.
[0084] As described herein, a single integral housing 100 may include one or more flanges 104 disposed at the proximal end of the tubular portion 102. For example, Figures 1A to 1F A pair of flanges 104 of the housing 100 are illustrated. However, the syringe accessory described herein is not intended to be limited to the two flanges shown, but may include at least one, two, three, four, or more flanges based on user preference. One or more flanges 104 may be larger than one or more flanges of a conventional manual syringe capable of being accommodated in the syringe accessory. For example, one or more flanges 104 may be about 1.25 times, 1.5 times, 1.75 times, 2 times, 2.5 times, 3 times, or more times the flange of a syringe. Therefore, flanges 104 can improve the user's grip during use of the syringe and syringe accessory.
[0085] In some embodiments, housing 100 may include one or more latches extending from the inner surface of housing toward the central longitudinal axis of tubular portion 102, examples of which are described in more detail herein. One or more flanges 104 of housing 100 may include one or more receiving portions configured to receive a syringe flange when a syringe is inserted into housing 100. For example, at least Figure 1A , Figure 1C and Figure 1F A receiving portion 110 configured to receive one or more flanges of a syringe is illustrated. The one or more receiving portions 110 may include one or more latches configured to latch, clamp, or removably lock into place with the one or more syringe flanges when they are inserted into the receiving portion 110. For example, during assembly, the syringe may be advanced into the tubular portion 102 of the housing 100 until the syringe flange is fully received by the receiving portion 110, and optionally removably locked in place by one or more latches disposed in the receiving portion 110 of the one or more flanges 104. Thus, the receiving portion 110 may be configured to restrict advance of the syringe into the tubular portion 102.
[0086] In some embodiments, the housing 100 may include one or more latches located at the proximal end of the tubular portion 102. For example, the tubular portion 102 may include one or more latches 105 configured to latch, clamp, or removably lock into place with a portion of the syringe barrel when the syringe is inserted into the tubular portion 102. At least regarding Figure 1A and Figure 1F A latch 105 is illustrated. The housing 100 may include the latch 105 in addition to or in place of the latch in the receiving portion 110.
[0087] In some embodiments, the tubular portion 102 may include one or more engagement surfaces located on the inner surface of the tubular portion 102. For example, one or more engagement surfaces may be provided at the proximal end of the tubular portion 102, at the distal end of the tubular portion 102, and / or elsewhere along the length of the tubular portion 102 between the proximal and distal ends. Figure 1CAn exemplary engagement surface 112 within the tubular portion 102 is illustrated. As shown, one or more engagement surfaces 112 may include one or more ridges or ribs raised from the inner surface of the tubular portion 102. In some embodiments, engagement surfaces on the housing 100 (e.g., engagement surfaces 112 within the tubular portion 102) may alternatively or additionally include one or more spring-loaded arms and / or one or more deformable tabs disposed along the inner surface of the tubular portion 102. In any case, at least a portion of one or more engagement surfaces 112 may extend from the inner surface of the tubular portion 102 toward the central longitudinal axis of the tubular portion 102. Thus, when the syringe barrel is inserted into the tubular portion 102 of the housing 100, one or more engagement surfaces 112 may contact the syringe (e.g., the syringe barrel) to provide traction and stability at least between the housing 100 and the syringe. In some embodiments, one or more engagement surfaces 112 may prevent the syringe from retracting from the housing 100 as a portion of the syringe (e.g., a portion of the syringe barrel) advances to or past one or more engagement surfaces. For example, where one or more engagement surfaces 112 include one or more spring-loaded arms, the syringe can be locked onto the spring-loaded arms once the syringe is advanced past them, preventing the syringe from retracting from the housing 100. The syringe body may include one or more external features (e.g., tabs extending from the outer surface of the syringe) that can engage with one or more engagement surfaces 112 on the housing 100.
[0088] A single integral housing 100 can be configured to be securely attached to a syringe (such as a syringe barrel, syringe flange, etc.) when the syringe barrel is received in the tubular portion 102 of the housing 100. For example, one or more of the aforementioned latches (e.g., latches on the receiving portion 110, engagement surface 112, latch 105, etc.) can securely attach the housing 100 to the syringe. Therefore, once assembled, the housing 100 and the syringe barrel cannot translate relative to each other. Instead, in this configuration, only the syringe plunger (e.g., plunger rod) can be advanced within the syringe barrel.
[0089] In some embodiments, the syringe accessory may be single-use. For example, after use, the syringe and syringe accessory may be appropriately discarded together. As described herein, the housing 100 may be securely attached to the syringe; however, it should be understood that the housing 100 may also be removably attached to the syringe under a predetermined amount of force applied by the user. Therefore, it is contemplated that in some embodiments, the housing 100 may be detached from the syringe and then sterilized to at least allow for the reuse of the syringe accessory.
[0090] The single integral housing 100 may include transparent, translucent, and / or opaque materials. For example, Figures 3A to 3B Figure 4 illustrates a syringe accessory including a shell with a transparent material. For example, where at least a portion of the shell material is opaque, the shell 100 may include one or more slits. The slits may allow the user of the syringe accessory to observe the fluid level and / or any markings on the syringe barrel during use. The material of the shell 100 may include polycarbonate, polypropylene, polyethylene, polyetheretherketone (PEEK), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), polyethylene terephthalate diol (PETG), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), or mixtures of polymers.
[0091] In some embodiments, the material of the housing 100 may be selected such that components of the syringe (such as one or more flanges, a portion of the syringe barrel, etc.) are deformable to removably lock into place within the housing 100. In other words, the material of the housing 100 may be stiffer or stronger than the material of the syringe. Alternatively, in some embodiments, the opposite scenario may occur, where the material of the housing 100 is selected such that a portion of the housing 100 (e.g., one or more latches, ribs, spines, clips, tabs, etc. on the housing 100) is deformable when the syringe is inserted into the housing 100. In a non-limiting example, polycarbonate syringe accessories that may be stiffer than polypropylene syringes can be manufactured.
[0092] In some embodiments, the syringe accessory may include a housing 100. That is, the syringe accessory described herein may include additional parts, components, or features not embodied within the housing 100. Alternatively, in some embodiments, the syringe accessory may be a housing 100. That is, the syringe accessory may not include any additional parts other than those described herein with respect to the housing 100. The housing 100 may be a single monolithic body. The single monolithic body may be manufactured from a single piece of material, for example, using injection molding or other techniques known to those skilled in the art. However, it is also contemplated that the housing 100 may include more than one body, such as two, three, or four bodies. In one example, the tubular portion 102 may include a first body, the flange 104 may include a second body, and the base portion 106 may include a third body, each individual body capable of removably attaching. Other combinations of features of the syringe accessory (e.g., the tubular portion 102, the flange 104, and the base portion 106) across different bodies are understood to be covered by the disclosure provided herein.
[0093] Figures 2A to 2GAn example of a syringe accessory according to a second embodiment is illustrated, the syringe accessory comprising a single integral housing 200. Syringe accessories including housing 200 may include, as described herein... Figures 1A to 1G The syringe accessory including housing 100 may include any one or more features. For example, housing 200 may include a tubular portion 202 configured to receive a syringe barrel, one or more flanges 204 located at a proximal end of tubular portion 202, and a base portion 206 located at a distal end of tubular portion 202. The base portion 206 may extend outward from the outer surface of tubular portion 202 toward its end in at least one direction.
[0094] In some embodiments, housing 200 may differ from housing 100 because housing 200 (e.g., tubular portion 202) may not include a contraction section. For example, tubular portion 202 may be configured to receive any syringe size described herein with respect to tubular portion 102. However, in some embodiments (e.g., for syringes with smaller volumetric capacities), the syringe accessory may not require a contraction section to restrict the advance of the syringe barrel through the housing (e.g., at least as...). Figure 2C (As shown). In this case, the advance of the syringe through the tubular portion 202 can be conversely limited by one or more receiving portions 210, one or more latches 205, one or more engagement surfaces 212, etc., of the flange 204 configured to receive the syringe. The receiving portions 210, latches 205, and engagement surfaces 212 may each include, as described herein, […]. Figures 1A to 1G The described receiving portion 110, latch 205, and engagement surface 112 are any one or more of the features.
[0095] Figure 3A and Figure 3B Examples of syringe and housing assemblies 150 and 250 are shown. For example, Figure 3A The component 150 shown may be included in Figures 1A to 1G The syringe accessories (e.g., housing 100) and syringe 120 are shown and described in relation to them. Figure 3B The component 250 shown may be included in Figures 2A to 2G The syringe accessories (e.g., housing 200) and syringe 220 are shown and described herein. This document refers to component 150 and... Figure 3A The described features are understood to apply to component 250 and Figure 3B ,vice versa.
[0096] Figure 3A The syringe 120 shown may include conventional syringe features known to those skilled in the art, including syringe barrel 122, needle 124, plunger 126, and in some embodiments includes a removable cap 128. Figure 3B The syringe 220 shown may include similar features, including a syringe barrel 222, a needle 224, a plunger 226, and a removable cap 228. Plungers 126 and 226 may include a plunger stop at a distal end of the plunger and a plunger rod extending from the plunger stop. As described herein, syringe 120 and / or syringe 220 may include additional features not explicitly stated. For example, syringes including other needle safety features (e.g., pivot needle guards, retractable needles, stops, etc.) are understood to be covered by the syringes described herein.
[0097] As described herein, housing 100 may be configured to limit the needle protrusion length, for example, beyond the base portion 106 of housing 100. For example, housing 100 may include one or more engagement surfaces 112, latches 105, and / or retraction portions 108 configured to limit movement of the syringe within housing 100 and, consequently, the amount of needle not shielded within housing 100. In some embodiments, a single integral housing 100 may be configured to limit the protrusion of needle 124 to between approximately 4 mm and 12 mm beyond the end of housing 100 (e.g., the end of base portion 106). In some embodiments, housing 100 may limit the protrusion of needle 124 to less than or equal to approximately 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, or 7 mm beyond the end of base portion 106. In some embodiments, housing 100 may limit the protrusion of needle 124 to greater than or equal to approximately 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm.
[0098] The needle 124, coupled to the distal end of the syringe 120, may include a Luer locking needle or a Luer sliding needle (e.g., a concentric or eccentric sliding needle). In some embodiments, the needle 124 may include a conventional needle or a safety needle. For example, the needle 124 may retract into the syringe barrel 122, the needle may be detachable from the rest of the syringe 120, and / or, as described herein, the needle 124 may be protected within a cap 128. For example, the cap 128 may be removable from the syringe 120, or in some embodiments, the cap may pivot between an open and closed position to cover the needle 124 before and / or after use.
[0099] In some embodiments, the syringe barrel 122 may be pre-filled. For example, the syringe barrel 122 may be pre-filled with an active pharmaceutical ingredient (API).
[0100] Figures 4A to 4BComponents 350 and 450 are illustrated relative to the injection site. Component 350 may include a syringe accessory (e.g., housing 300) and a syringe 320. Similarly, component 450 may include a syringe accessory (e.g., housing 400) and a syringe 420. In some embodiments, components 350 and 450 may include component 150 (e.g., housing 100 and syringe 120) or component 250 (e.g., housing 200 and syringe 220). Each feature described herein with respect to component 350 is to be understood to apply to component 450, and vice versa.
[0101] like Figure 4A As shown, the housing 300 can be configured to elevate the skin portion 330 at the injection site 340. When the base portion 306 contacts the injection site 340, the elevated skin 330 can be located within the periphery of the base portion 306. In other words, as shown, the housing 300 can be configured to create a "bubble" of skin 330 that facilitates injection at the injection site 340. Figure 4A It can be illustrated that the contact surface provided by the housing 300 at the injection site 340 is based on the outer portion of the base portion 306 (e.g., as described above regarding...). Figures 1A to 1G The embodiment shown is the base portion 306. The base portion 306 of the housing 300 may additionally include an internal portion (e.g., an internal portion 116 that is distinct from the external portion 114 of the base portion 106, such as...). Figure 1G (as shown), however, the internal portion may not affect the manner in which the skin 330 is raised at the injection site 340.
[0102] Figure 4B A similar implementation is illustrated, wherein when the base portion 406 comes into contact with the injection site 440, the skin 430 may be raised at the injection site 440. Figure 4B An example can be illustrated where the contact surface provided by the housing 400 at the injection site 440 is based on the outer and inner portions of the base portion 406 (e.g., in...). Figure 1G An embodiment is shown in the diagram and described above with respect to the outer portion 114 and the inner portion 116. The base portion 406 of the housing 400 may include a gap between the outer portion and the inner portion of the base portion 406 (e.g., as described herein at least with respect to the outer portion 114 and the inner portion 116). Figure 1G As described, as shown, a portion of the skin 430 can be raised into the gap. The skin 430 can also be raised, alternatively or additionally, by the base portion 406 of the housing 400 into an opening surrounded by the inner portion (e.g., through which a syringe needle passes).
[0103] As described herein, the housing 300 can be configured to limit the protrusion of the syringe needle beyond the housing (e.g., beyond the base portion of the housing). Therefore, the housing 300 can be configured to limit the depth to which the needle can be injected into the skin. For example, the housing 300 can limit the needle from being injected into the subcutaneous layer of the skin, into muscles (e.g., intramuscular), into the dermis of the skin (e.g., intradermal, subepidermal), or into a vein (e.g., intravenous). As those skilled in the art will understand, the depth of injection can be controlled by modifying the body length of the housing 300 and / or the length of the needle used with the syringe.
[0104] As described herein, the end portion of the base portion 306 can be configured to provide a stable contact surface at the injection site. For example, the base portion 306 can provide a plane coplanar with the end surface of the base portion 306 and an axis orthogonal to said plane (e.g., Figures 1A to 1D and Figure 1G A consistent injection angle between 80° and 100° is measured between the Y-axis (shown in the diagram). In some embodiments, the injection angle provided by the base portion 106 can be greater than or equal to 80°, 82°, 85°, 88°, or 90°. In some embodiments, the injection angle provided by the base portion 106 can be less than or equal to 100°, 98°, 95°, 92°, or 90°. For example, the injection angle can be between 80-95 degrees, 80-92 degrees, 80-90 degrees, 82-100 degrees, 82-95 degrees, 82-90 degrees, 85-100 degrees, 85-98 degrees, 85-95 degrees, 85-90 degrees, 88-100 degrees, 88-98 degrees, 88-95 degrees, 90-100 degrees, 90-98 degrees, or 90-95 degrees.
[0105] Figures 5A to 5D Another syringe accessory housing 500 is illustrated, the features of which are to be understood as applicable to any syringe accessory housing described herein (e.g., housing 100, 200, etc.). Figures 5A to 5D The housing 500 shown may differ from those previously described because the housing 500 may include a locking member 508 disposed at the proximal end of the tubular portion 502 for retaining the syringe 520 within the housing 500 (e.g., Figure 5B (as shown in component 550).
[0106] A locking member 508 may be positioned at the proximal end of the tubular portion 502, at least partially within one or more flanges 504. The locking member 508 may include an elongated portion 512 for limiting translational movement of the locking member 508 within the housing 500. The locking member 508 may include a central portion 514 that engages with the syringe 520 when inserted into the tubular portion 502. The central portion 514 may be configured to limit axial movement of the locking member 508 within the housing. The locking member 508 may be movable (e.g., translated) from an unlocked position to a locked position, in which the syringe 520 may be inserted into the tubular portion 502 of the housing 500, and in the locked position, the syringe 520 may be locked within the tubular portion 502 by the locking member 508. Figures 5A to 5D An example is shown of a housing 500 and its locking member 508 in the locked position. The following describes the features of the housing 500 and its locking member 508 that can implement this locking mechanism.
[0107] The housing 500 may include a track 518 configured to maintain the position of the locking member 508 along the X-axis. The track 518 may be disposed within one or more flanges 504 to receive an elongated portion 512 of the locking member 508. The track 518 may be configured to restrict movement of the locking member 508 along the X-axis. For example, the track 518 may include one or more openings 519 along its length, configured to receive one or more fins 513 projecting from the elongated portion 512. Once the one or more fins 513 are disposed within the one or more openings 519, movement of the locking member 508 can be restricted (e.g., within a threshold amount of movement).
[0108] The housing 500 may include a slot 521 located at the outer end of one or more flanges 504, the slot being configured to receive an elongated portion 512 of the locking member 508. In the unlocked position (i.e., a position where the housing 500 can be provided for inserting a syringe 520 into the housing 500), the elongated portion 512 may extend through the slot 521 to the outside of the housing 500. The elongated portion 512 may be deformable such that the fin 513 may retract within the track 518 in the unlocked position. For example, the elongated portion 512 may include one or more elongated members 511 separated by one or more openings 516 for deforming the elongated portion 512. Figures 5A to 5DIn the example shown, the elongated portion 512 may include three elongated members 511 separated by two openings 516. Fins 513 may be disposed on one or more of the outermost elongated members 511. To advance the locking member 508 into the locked position, a user may push the end of the elongated portion 512 through the slot 521 and along the track 518 to the outside of the housing 500 until one or more fins 513 engage in one or more openings 519 of the track 518. The one or more openings 519 may be positioned along the length of the track 518 such that when the fins 513 are received therein, the central portion 514 of the locking member 508 is positioned to retain the syringe 520 within the housing 500.
[0109] In some examples, the locking member 508 may be configured to removably lock the syringe 520 in place within the housing 500. For example, the elongated portion 512 may be deformable to allow the locking member 508 to move back to the unlocked position after use in the locked position. In this example, one or more fins 513 may be configured to retract back into the track 518 after being positioned in one or more openings 519 in the locked position. In this way, the syringe 520 can be removed from the housing 500 after use, and the housing 500 can be reused.
[0110] The housing 500 may include one or more slots 510 configured to hold the locking member 508 in position within the XY plane. One or more slots 510 may be located at the proximal end of the tubular portion 502 to receive one or more external tabs 515 projecting outward from the central portion 514 of the locking member 508 away from the longitudinal axis of the tubular portion 502. In both the unlocked and locked positions of the locking member 508, the one or more external tabs 515 may be translatable within the one or more slots 510 of the housing 500. The central portion 514 may include one or more internal tabs 517 projecting outward from the central portion 514 toward the longitudinal axis of the tubular portion 502. In the locked position of the locking member 508, the one or more internal tabs 517 may extend over the syringe 520 to hold the syringe 520 in place.
[0111] Figures 6A to 6B Another syringe accessory housing 600 is illustrated, the features of which are to be understood to be applicable to any syringe accessory housing described herein (e.g., housing 100, 200, etc.). Figures 6A to 6B The housing 600 shown may differ from those previously described because housing 600 may include an opening 608 and one or more retaining portions 612 that extend at least a portion of the length of the tubular portion 602, the one or more retaining portions being configured to... Figure 6B (As shown in component 650) When the tubular portion 602 is inserted, it is held in place. The size (e.g., length) of the opening 608 can be designed such that the barrel of the syringe 620 can be inserted into the housing 600 through the opening 608. The opening 608 can extend only a portion of the circumference of the tubular portion 602, such that the tubular portion 602 still surrounds at least a portion of the syringe 620 when inserted therein.
[0112] Once the syringe 620 is inserted into the housing 600, one or more retaining portions 612 can maintain the syringe 620 in position within the tubular portion 602. For example, one or more retaining portions 612 may protrude into the lumen of the tubular portion 602 configured to receive the syringe 620. In this way, when the syringe is inserted into the tubular portion 602, one or more retaining portions 612 can be configured to securely contact the syringe 620 to hold it in place. In some examples, the proximal end of the syringe 620 may include one or more syringe flanges 622, and the housing 600 may be configured to receive the syringe flanges 622 in one or more corresponding receiving portions 610. One or more receiving portions 610 may be located at the proximal end of the tubular portion 602, adjacent to one or more flanges 604. In some examples, one or more receiving portions 610 include one or more slots, such as extending at least a portion of the circumference of the tubular portion 602 as a single slot corresponding to the size of one or more syringe flanges 622. By using one or more receiving portions 610 and / or one or more retaining portions 612, the position of the syringe 620 within the housing 600 can be secured to ensure safe use of the syringe 620. In some examples, the controller 620 may be removably secured within the housing 600. For example, one or more retaining portions 612 may be deformable to a degree that allows the user to remove the syringe 620 from the housing 600 by pulling it out of the tubular portion 602.
[0113] Figures 7A to 7B Another syringe accessory housing 700 is illustrated, the features of which are to be understood to be applicable to any syringe accessory housing described herein (e.g., housing 100, 200, etc.). Figures 7A to 7B The housing 700 shown may differ from those previously described, because the housing 700 may include a means for receiving the syringe 720 (in... Figure 7B (As shown in component 750) a door 708 inserted into and removed from the tubular portion 702. For example, the tubular portion 702 may include a door 708 with respect to... Figures 6A to 6BThe opening 608 described in the housing 600 shown is similar to an opening, and a door 708 can allow and restrict access to the opening for inserting and removing the syringe 720 into the tubular portion 702. The door 708 can be engaged to the tubular portion 702 at a hinge 712. The door 708 can be removably attached to the tubular portion 702 to retain the syringe 720 within the housing 700. For example, the door 708 can be removably attached to the tubular portion 702 on the opposite side of the tubular portion 702 relative to the hinge 712.
[0114] Such as about Figures 6A to 6B As described in the housing 600, the housing 700 may include one or more receiving portions 710 configured to receive one or more syringe flanges 722. The receiving portion 710 may include any one or more features described with respect to the receiving portion 610. By using one or more receiving portions 710 and / or a door 708, the syringe 720 can be secured within the housing 700 to enable safe use of the syringe 720. In some examples, the controller 720 may be removably secured within the housing 700. For example, the door 708 may be opened, and the user can remove the syringe 720 from the housing 700 by pulling it out from the tubular portion 702.
[0115] Figures 8A to 8B Another syringe accessory housing 800 is illustrated, the features of which are to be understood to be applicable to any syringe accessory housing described herein (e.g., housing 100, 200, etc.). Figures 8A to 8B The housing 800 shown may differ from those previously described because the housing 800 may include an opening 808 extending the length of the tubular portion 802 and the length of the base portion 806. The housing 800 may be particularly advantageous, for example, in a syringe 820 into which the housing 800 is inserted, including a needle safety feature protruding from the barrel of the syringe 820. Figures 8A to 8B In cases where not explicitly stated in the text; however, in Figures 9A to 9B A similar syringe is shown, described in more detail below. However, the housing 800 is not intended to be limited to use with syringes having such needle safety features, and can be used with syringes that do not include these features. For example, Figure 9B Component 950 illustrates a syringe 820 disposed within a housing 800, the syringe not including any particular features protruding from the barrel of the syringe 820. However, the housing 800 may use one or more retaining portions 812 and / or receiving portions 810 to retain the syringe 820 within the tubular portion 802. As stated above regarding at least Figures 6A to 6B and Figures 7A to 7BAs described, one or more retaining portions 812 may be configured to retain the syringe 820 in a suitable position within the tubular portion 802. One or more receiving portions 810 may be configured to receive one or more syringe flanges 822 of the syringe 820. The housing 800 may be configured to removably secure the syringe 820 within the housing 800.
[0116] Figures 8C to 8D A base portion 806 of housing 800 is illustrated. It should be understood that base portion 806 can be used in any syringe accessory housing described herein (e.g., housing 100, 200, etc.). As described above, base portion 806 may include an opening 808 extending the length of base portion 806. Despite the opening 808, base portion 806 can still be configured to provide a stable surface on the patient's skin because opening 808 may extend only a portion of the circumference of base portion 806. For example, opening 808 may extend less than 50% (e.g., 40%, 30%, 25%, 20% or less) around the circumference of base portion 806, thereby enabling the remainder of the distal end of base portion 806 to provide a stable surface for injection. At least the distal portion of the inner surface 807 of base portion 806 may have a concave shape to receive the patient's skin when base portion 806 is applied under pressure to the patient's skin, which may allow the skin to protrude into base portion 806.
[0117] Figures 9A to 9B Another syringe accessory housing 900 is illustrated, the features of which are to be understood to be applicable to any syringe accessory housing described herein (e.g., housing 100, 200, etc.). Figures 9A to 9B The housing 900 shown can be similar to the one described above. Figures 7A to 7B The housing 700 is described, as the housing 900 also includes a door 908. However, the housing 900 can differ from the housing 700 (and other previously described syringe accessory housings) because the door 908 may extend only a portion of the length of the tubular portion 902. The shorter door 908 may be intended, for example, to enable the housing 900 to be used with a syringe having one or more features (e.g., a needle safety feature) protruding from the barrel of the syringe 920. Figure 9B An example of this situation is depicted in component 950, wherein syringe 920 includes a needle safety slide 926 (depicted in a retracted position) for shielding the needle of syringe 920 after use. Door 908 and / or one or more receiving portions 910 (located at the proximal end of tubular portion 902, near one or more flanges 904) can be configured to secure syringe 920 within housing 900 for safe use of syringe 920.
[0118] The housing 900 may further differ from the housing previously described because the opening 914 (part of which may be covered by the door 908) may extend at least the length of the base portion 906 (in addition to the length of the extended tubular portion 902). The opening 914 may extend the length of the tubular portion 902 and at least a portion of the length of the extended base portion 906 for a variety of reasons. For example, a longer opening 914 may make it easier for the syringe 920 to be inserted into the housing 900. This may be advantageous, for example, when the syringe 920 inserted into the tubular portion 902 includes additional accessories that may increase the size of the syringe 920 inserted into the housing 900. Exemplary accessories may include a removable shield 924, such as... Figure 9B As shown. Additionally or alternatively, the opening 914 extending into the base portion 906 can ensure the full deployment of the needle safety slide 926 after use of the syringe 920.
[0119] like Figures 9A to 9B As shown, the opening 914 may not extend the entire length of the base portion 906. For example, the distal end of the base portion 906 may not have an opening along its side. The entire distal surface of the base portion 906 can provide a stable surface for safe injection by the syringe 920. The base portion 906 in Figures 9C to 9D Further examples are provided. It should be understood that the characteristic portion of the base portion 906 can be used for any housing base portion described herein. As shown, the base portion 906 may include a convex distal surface 916. This convex distal surface 916 can provide a smooth and stable engagement surface between the patient's skin and the base portion 906 for safe injection by the syringe. In some examples, applying pressure to the base portion 906 of the housing 900 onto the patient's skin can cause a portion of the patient's skin at the injection site to protrude into the lumen 915 of the base portion 906.
[0120] Figures 10A to 10B Another base portion 1006 for a syringe accessory housing is illustrated, which may be similar to the one described above. Figures 9A to 9D The base portion 906 is described. The base portion 1006 is understood to be usable in any housing described herein. The base portion 1006 may differ from the base portion 906 because it may not include an opening therein. The base portion 1006 may include a similar convex distal surface 1016 that provides a smooth and stable surface for injection onto a patient's skin. In some examples, when the housing including the base portion 1006 is applied under pressure to the injection site, the skin at the injection site may protrude into the lumen 1015 of the base portion 1006.
[0121] Figures 11A to 11BAnother base portion 1106 for a syringe accessory housing is illustrated, which may be similar to the one described above. Figures 10A to 10B The base portion 1006 is described. The base portion 1106 is understood to be usable in any housing described herein. The base portion 1106 may differ from the base portion 1006 because the base portion 1006 may include one or more ribs 1120 separating one or more openings 1118. The base portion 1106 may include a similar convex distal surface 1116, which, despite the openings 1118, provides a smooth and stable surface for injection onto the patient's skin. This stable surface may be provided at least partially by the ribs 1120. In some examples, when the housing including the base portion 1106 is applied under pressure to the injection site, the skin at the injection site may protrude into the lumen 1115 and / or opening 1118 of the base portion 1106. Providing additional space for the patient's skin to protrude therein when the base portion 1106 is applied under pressure to the injection site can be beneficial in creating a stable surface for injection. Additionally or alternatively, the benefit of base portion 1106 may be that base portion 1106 is lighter in weight than an alternative base portion without any openings. This may also have manufacturing benefits, as base portion 1106 may require less material to produce.
[0122] Figures 12A to 12B Another base portion 1206 for a syringe accessory housing is illustrated, which can be used in any housing described herein. In some examples, the base portion 1206 can be at least similar to Figures 1A to 1G The base portion 106 is shown. However, the base portion 1206 may differ from the base portion 106 because the base portion 1206 may include an inner portion 1224 that extends distally to the outer portion 1222 of the base portion 1206. In other words, the distal end of the outer portion 1222 may extend to a first plane, and the distal end of the inner portion 1224 may extend to a second plane parallel to and distal to the first plane. During use, at least the distal end of the inner portion 1224 of the base portion 1206 may contact the patient's skin. In some examples, depending on the amount of pressure applied to the patient's skin using the housing including the base portion 1206, the patient's skin may also contact the outer portion 1222. For example, the skin at the injection site may protrude into one or more openings 1218 between the inner portion 1224 and the outer portion 1222. Because the inner portion 1224 extends distally to the outer portion 1222, the skin can also protrude into one or more openings 1218 in addition to protruding into the lumen 1215 of the base portion 1206.
[0123] Figures 13A to 13BAn example is shown of a base portion 1306 for a syringe accessory housing, which can be used in any housing described herein. In some examples, the base portion 1306 can be at least similar to Figures 1A to 1G The base portion 106 is shown. The base portion 1306 can be optimized such that the diameter of each of the inner portion 1324 and the outer portion 1322 produces a stable surface at the injection site.
[0124] During use, the distal ends of each of the inner portion 1324 and the outer portion 1322 of the base portion 1206 may contact the patient's skin. When pressure is applied to the skin through the base portion 1306, the skin at the injection site may protrude into one or more openings 1318 between the inner portion 1324 and the outer portion 1322 and / or protrude into the lumen 1315 within the inner portion 1324.
[0125] Figures 14A to 14B Another base portion 1406 for a syringe accessory housing is illustrated, which can be used in any housing described herein. Base portion 1406 can be similar to... Figures 13A to 13B The base portion 1306 described is different from the base portion 1406, which may not include the different inner portion 1324 and outer portion 1322. Instead, the base portion 1406 may include only the outer portion 1422. The distal end of the outer portion 1422 may provide a stable surface for injection onto the patient's skin. For example, the outer portion 1422 may extend outward toward the distal end in one or more directions (or be funnel-shaped). The base portion 1006 may include a concave distal surface 1407 into which the skin may protrude when pressure is applied to the patient's skin during use of the housing including the base portion 1406.
[0126] Figures 15A to 15BAnother base portion 1506 for a syringe accessory housing is illustrated, which can be used in any housing described herein. Base portion 1506 may differ from the base portions previously described and illustrated (e.g., base portion 1406) because, as base portion 1506 extends distally, its outer surface 1522 may recede inwardly toward the longitudinal axis of base portion 1506. Therefore, base portion 1506 may not include a concave or convex distal surface for contact with the patient's skin. Instead, the distal end of the outer surface 1522 that contacts the injection site may be the smallest diameter of base portion 1506, and thus provide a minimal contact surface with the skin. This embodiment may be advantageous to more experienced users who desire a certain amount of support from the syringe accessory, but also desire to manipulate the angle at which the syringe with the accessory contacts the injection site. Since the diameter of the circular outer surface 1522 decreases as it extends to the distal end of the base portion 1506, the housing having the base portion 1506 can be manipulated in this manner. When pressure is applied to the injection site with the base portion 1506, the skin at the injection site can protrude into the cavity 1515 of the base portion 1506.
[0127] Figure 16 Additional features that may be included on the housing described herein are illustrated. Figure 16 A portion of a tubular portion 1602 according to some embodiments is illustrated, the tubular portion including a finger pad 1603 disposed along the length of the tubular portion 1602. The finger pad 1603 is reasonably understood to be usable in any housing described herein. The finger pad 1603 can be ergonomically configured so that a user can hold the finger pad 1603 while using a syringe with syringe attachments thereon, thereby increasing the flexibility of the device. The finger pad 1603 can be positioned at any desired location along the length of the tubular portion 1602. For example, the finger pad 1603 can be positioned along the distal portion, the proximal portion, or between the distal and proximal portions of the tubular portion 1602.
[0128] Methods for assembling syringes and syringe components This document provides a method for assembling syringe accessories and syringes. For example, syringe accessories may include those described in this document. Figures 1A to 1G and Figures 2A to 2GThe 100 or 200 described herein. Therefore, the syringe accessory described herein may include a single integral housing comprising a tubular portion, one or more flanges located at a proximal end of the tubular portion, and a base portion located at a distal end of the tubular portion. The base portion may extend outward from the outer surface of the tubular portion toward the end of the base portion in at least one direction to provide a stable contact surface at the injection site. The syringe may include the features of the syringe described herein, such as features of a conventional manual syringe (e.g., barrel, plunger rod, plunger stop, needle, and one or more flanges). The method is also understood to be suitable for applications such as... Figures 5A to 5B , Figures 6A to 6B , Figures 7A to 7B , Figures 8A to 8D and Figures 9A to 9B The image shows syringe accessories and components, including a syringe.
[0129] The method may include inserting the syringe barrel into the proximal end of a tubular portion of a syringe accessory. For example, the end of the syringe barrel that is attached (or will be attached) to the needle may be inserted into the proximal end of the tubular portion.
[0130] The method may include advancing the syringe barrel toward the distal end of the tubular portion. The syringe barrel may be advanced until one or more flanges of the syringe are clamped onto one or more latches on the inner surface of the syringe attachment. For example, one or more latches may be located in one or more receiving portions of one or more flanges and / or at the distal end of the tubular portion of the single integral housing. One or more latches may extend from the inner surface of the syringe attachment (e.g., the inner surface of one or more flanges and / or the tubular portion of the housing) toward the central longitudinal axis of the tubular portion of the housing. Thus, one or more latches may clamp the syringe flanges to prevent the syringe from retracting from the syringe attachment as the one or more flanges of the syringe are advanced distally past one or more latches. In some embodiments, one or more latches located on the inner surface of the syringe attachment may additionally or alternatively include one or more engagement surfaces, such as one or more ribs, spines, spring-loaded arms, and / or one or more deformable tabs on the inner surface of the tubular portion. In any case, the single integral housing may be securely attached to the syringe barrel when the syringe barrel is fully inserted into the tubular portion of the single integral housing.
[0131] The tubular portion may include a proximal portion and a distal portion, the proximal portion receiving the syringe barrel and the distal portion shielding at least a portion of the syringe needle when the barrel is inserted into the proximal portion. In some embodiments, the tubular portion may include a constriction along the length of the tubular portion between the proximal and distal portions, the constriction restricting needle protrusion when the syringe barrel is inserted into the proximal portion of the tubular portion.
[0132] After assembly, the syringe and syringe accessory assembly can be used to inject APIs. This syringe and syringe accessory assembly provides a stable contact surface for injection, as well as a consistent injection angle. A method for injecting APIs using the syringe and syringe accessory assembly described herein is provided below.
[0133] Method of injecting API using syringes and syringe accessories This document provides methods for using syringe accessories with syringes. For example, this document provides a method for injecting an active pharmaceutical ingredient (API) contained in a syringe. The syringe can be contained in a syringe accessory described according to the embodiments provided herein. For example, the syringe accessory may include, respectively, those described herein. Figures 1A to 1G and Figures 2A to 2G The described housing 100 or 200. Therefore, a syringe for injection can be housed in a single integral housing comprising: a tubular portion receiving the syringe barrel; one or more flanges located at a proximal end of the tubular portion; and a base portion located at a distal end of the tubular portion. The method is also understood to be suitable for applications such as... Figures 5A to 5B , Figures 6A to 6B , Figures 7A to 7B , Figures 8A to 8D and Figures 9A to 9B The image shows syringe accessories and components, including a syringe.
[0134] The syringe may be pre-loaded with an API. Alternatively, in some embodiments, the method may include loading the API onto the syringe. For example, the user may load the syringe before assembling the syringe and syringe accessories.
[0135] This method may include inserting a syringe into a single integral housing, as described above in the exemplary method of assembling a syringe and syringe accessories. In some embodiments, inserting the syringe into the syringe accessory may include advancing the syringe into a tubular portion of the housing until one or more flanges of the syringe contact one or more latches disposed on one or more flanges of the housing and / or the inner surface of the tubular portion. As the one or more flanges are advanced distally past the one or more latches, the one or more latches may clamp the one or more flanges of the syringe to prevent the syringe from retracting from the housing. In some embodiments, the one or more latches may include one or more engagement surfaces, such as ribs, spines, clips, spring-loaded arms, and / or one or more deformable tabs disposed on the inner surface of the tubular portion of the housing.
[0136] In some embodiments, inserting the syringe into a single integral housing may additionally or alternatively include advancing the syringe into a tubular portion of the housing until the distal end of the syringe barrel contacts a contraction along the length of the tubular portion. For example, the tubular portion of the single integral housing may include a proximal portion receiving the syringe barrel, and a distal portion shielding at least a portion of the needle when the barrel is received in the proximal portion. The distal and proximal portions may be distinguished by the contraction. In this way, when the syringe is received in the tubular portion of the housing before use (e.g., in the proximal portion of the tubular portion), the housing may restrict needle protrusion (e.g., even if the needle has not yet been inserted into the injection site).
[0137] In any case, as described herein, a single integral housing can be securely attached to the syringe barrel when the barrel is fully inserted into the tubular portion of the housing.
[0138] In some implementations, the syringe needle may be protected by a removable cap. Therefore, the method may include removing the cap from the needle before inserting it into the injection site, and then injecting the API.
[0139] This method may include inserting the needle of a syringe (a syringe disposed in a single integral housing) into an injection site. Inserting the needle into the injection site may include advancing the needle into the injection site until the end of the base portion providing a stable contact surface contacts the injection site. In some embodiments (e.g., where the syringe includes a retractable needle feature), a syringe attachment may be placed on the injection site first, such that the base portion contacts the injection site before the needle is advanced into the injection site. In this case, substantially all of the needle can be shielded by the syringe attachment before use, and the syringe needle can be advanced toward the injection site to contact the site while the housing maintains stable contact at the injection site. When the base portion contacts the injection site, the base portion may elevate a portion of the skin at the injection site. For example, at least a portion of the skin located within the periphery of the base portion may be elevated based on contact with the base portion.
[0140] This method may include injecting an API contained in a syringe at an injection site at a needle depth limited by a single monolithic housing. For example, the housing may limit the injection depth to subcutaneous, intramuscular, intradermal, and / or intravenous injection sites. In some embodiments, a combination of needle length and features of the housing (e.g., latch, retraction, etc.) may provide a desired needle protrusion length from the syringe and syringe accessory assembly. For example, at least a single monolithic housing may limit the needle depth at the injection site to between 4 mm and 12 mm (e.g., for subcutaneous injection), depending on the desired injection site. For example, intramuscular injections may require a longer needle depth, while skin injections may require a shorter needle depth. As described herein, during API injection to the injection site, a single monolithic housing (e.g., the base portion of the housing) may provide a consistent injection angle relative to the injection site. For example, the injection angle may be between 85 degrees and 95 degrees.
[0141] In some embodiments, the injection of APIs using the syringes and syringe accessory components provided herein can be achieved using a syringe device that embodies at least each of the features described herein with respect to the various embodiments of syringe accessories. For example, the syringe device can provide a stable contact surface and a consistent injection angle. Exemplary syringe devices and methods of using them are provided below.
[0142] syringe device In some embodiments, a syringe device may be provided that includes one or more features of the syringe accessories described herein. Although a housing configured to receive a syringe is shown and described herein, it is contemplated that the syringe and housing may be provided as a single piece. For example, refer to Figure 3A The barrel 122 of the syringe 120 may include any one or more features of the housing 100 described herein. In such embodiments, the syringe device may include at least a plunger and a single integral housing including a barrel configured to receive a plunger (e.g., at least a plunger rod), one or more flanges located at a proximal end of the barrel, and a base portion located at a distal end of the barrel. The base portion of the syringe device may include features described herein. Figures 1A to 1G , Figures 2A to 2G and Figures 4A to 4B The base portion 106, 206, 306, and / or 406 described herein refers to any one or more of the features. For example, the base portion may extend from the outer surface of the cylinder toward an end of the base portion in at least one direction, the end of which is configured to provide a stable contact surface at the injection site. More generally, the housing may include features described herein. Figures 1A to 1G , Figures 2A to 2G , Figures 3A to 3B and / or Figures 4A to 4B The housings 100, 200, 300, and / or 400 describe any one or more features. For example, the housing may be a single integral housing configured to limit the protrusion of the needle when it is engaged with the distal end of the tube.
[0143] Method of injecting API using a syringe device This document provides methods for using the aforementioned syringe device. For example, this document provides a method for injecting an active pharmaceutical ingredient (API) contained in a syringe. The syringe device used in these methods may include any one or more features of the aforementioned syringe device described according to the embodiments provided herein. For example, a syringe device for injection may include at least a plunger and a single integral housing including a barrel configured to receive the plunger (e.g., at least a plunger rod), one or more flanges located at a proximal end of the barrel, and a base portion located at a distal end of the barrel.
[0144] The syringe device may come pre-loaded with an API. Alternatively, in some embodiments, the method may include loading the API into the syringe device. For example, the user may load the syringe before assembling the syringe and syringe accessories.
[0145] In some embodiments, the needle of the syringe device may be protected by a removable cap. Therefore, the method may include removing the cap from the needle before inserting it into the injection site, and subsequently injecting the API.
[0146] The method may include inserting a needle of a syringe device into an injection site. Inserting the needle into the injection site may include advancing the needle into the injection site until the end of the base portion providing a stable contact surface contacts the injection site. In some embodiments (e.g., where the syringe includes a retractable needle feature), the syringe device may be initially placed on the injection site such that the base portion contacts the injection site before the needle is advanced into the injection site. In this case, substantially all of the needle can be shielded by the syringe device before use, and the syringe needle can be advanced toward the injection site to contact the site while the housing maintains stable contact at the injection site. When the base portion contacts the injection site, the base portion may elevate a portion of the skin at the injection site. For example, at least a portion of the skin located within the periphery of the base portion may be elevated based on contact with the base portion.
[0147] This method may include injecting an API contained in a syringe at an injection site at a needle depth limited by a single integral housing. For example, the housing may limit the injection depth to subcutaneous, intramuscular, intradermal, and / or intravenous injection sites. In some embodiments, a combination of needle length and features of the housing (e.g., latch, retraction, etc.) may provide a desired needle protrusion length from the syringe and syringe accessory assembly. For example, at least a single integral housing may limit the needle depth injected at the injection site to between 4 mm and 12 mm, depending on the desired injection site. As described herein, during API injection to the injection site, the single integral housing (e.g., the base portion of the housing) may provide a consistent injection angle relative to the injection site. For example, the injection angle may be between 85 degrees and 95 degrees.
[0148] Unless otherwise defined, all specialized terms, symbols, and other technical and scientific terms or specialized expressions used herein are intended to have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some instances, for clarity and / or ease of reference, terms with commonly understood meanings are defined herein, and these definitions should not necessarily be construed as indicating a significant difference from the meanings commonly understood in the art.
[0149] As used herein, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” also include the plural forms. It should also be understood that, as used herein, the term “and / or” refers to and covers any and all possible combinations of one or more of the associated listed items. It should also be understood that, when used herein, the terms “comprising” and / or “including” specify the presence of the stated feature, integer, step, operation, element, component, and / or unit, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.
[0150] The disclosed numerical ranges inherently support any range or value within the disclosed numerical ranges, including endpoints, even if no precise range limitation is stated verbatim in the specification, because this disclosure can be practiced throughout the entire disclosed numerical range.
[0151] For purposes of explanation, the foregoing description has been described with reference to specific embodiments. However, the foregoing illustrative discussion is not intended to be exhaustive or to limit the invention to the exact forms disclosed. Many modifications and changes can be made to this disclosure based on the foregoing teachings. The embodiments were chosen and described in order to best explain the principles of these techniques and their practical application. Thus, it is made possible for others skilled in the art to best utilize these techniques and various embodiments with various modifications suitable for the particular intended use.
[0152] Although this disclosure and examples have been fully described with reference to the accompanying drawings, it should be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood to be included within the scope of this disclosure and examples as defined by the claims.
[0153] Implementation Plan Implementation Scheme 1. A syringe accessory, the syringe accessory comprising: A single integral housing, the single integral housing comprising: A tubular portion, the tubular portion being configured to receive a syringe barrel; One or more flanges, said one or more flanges being located at the proximal end of said tubular portion; and A base portion, located at the distal end of the tubular portion, extends outward from the outer surface of the tubular portion toward its end in at least one direction, and the end of the base portion is configured to provide a stable contact surface at the injection site. The single integral housing is configured to restrict the protrusion of the syringe needle when the syringe barrel is received in the tubular portion.
[0154] Implementation Scheme 2. The syringe accessory according to claim 1, wherein the base portion has a cross-sectional dimension larger than that of the tubular portion.
[0155] Implementation Scheme 3. The syringe accessory according to Implementation Scheme 1 or 2, wherein the base portion includes a flared shape extending outward from the outer surface of the tubular portion toward the end of the base portion that provides the stable contact surface.
[0156] Implementation Scheme 4. The syringe accessory according to any one of Implementation Schemes 1 to 3, wherein the base portion is configured to elevate the skin portion of the injection site located within the periphery of the base portion when the base portion contacts the injection site.
[0157] Implementation Scheme 5. The syringe accessory according to any one of Implementation Schemes 1 to 4, wherein the single integral housing is configured to provide an injection angle between 85 degrees and 95 degrees relative to the contact surface.
[0158] Implementation Scheme 6. The syringe accessory according to any one of Implementation Schemes 1 to 5, wherein the single integral housing includes one or more latches extending from the inner surface of the housing toward the central longitudinal axis of the tubular portion.
[0159] Implementation Scheme 7. The syringe accessory according to Implementation Scheme 6, wherein the one or more latches are disposed at the proximal end of the tubular portion and are configured to clamp the syringe barrel as it is advanced distally past the one or more latches to prevent the syringe from retracting from the single integral housing.
[0160] Implementation Scheme 8. The syringe accessory according to Implementation Scheme 6 or 7, wherein the one or more latches include one or more ribs, spring-loaded arms and / or one or more deformable tabs disposed on the inner surface of the tubular portion.
[0161] Implementation Scheme 9. The syringe accessory according to any one of Implementation Schemes 1 to 8, wherein the tubular portion of the single integral housing is configured to receive the barrel of a syringe with a volumetric capacity between 0.1 mL and 70 mL.
[0162] Implementation Scheme 10. The syringe accessory according to any one of Implementation Schemes 1 to 9, wherein the tubular portion of the single integral housing is configured to receive a 3 mL syringe or a 5 mL syringe.
[0163] Implementation Scheme 11. The syringe accessory according to any one of Implementation Schemes 1 to 10, wherein the single integral housing is configured to limit the protrusion of the needle to between 4 mm and 12 mm beyond the end of the base portion.
[0164] Implementation Scheme 12. The syringe accessory according to any one of Implementation Schemes 1 to 11, wherein the syringe accessory is for single use.
[0165] Implementation Scheme 13. The syringe accessory according to any one of Implementation Schemes 1 to 12, wherein the syringe accessory is the single integral housing.
[0166] Implementation Scheme 14. The syringe accessory according to any one of Implementation Schemes 1 to 13, wherein the tubular portion includes a proximal portion and a distal portion, the proximal portion being configured to receive the barrel of the syringe, and the distal portion being configured to shield at least a portion of the needle of the syringe when the barrel is received in the proximal portion.
[0167] Implementation Scheme 15. The syringe accessory according to Implementation Scheme 14, wherein the tubular portion includes a constriction portion located along the length of the tubular portion between the proximal portion and the distal portion, the constriction portion being configured to limit the protrusion of the needle when the barrel of the syringe is received in the proximal portion of the tubular portion.
[0168] Implementation Scheme 16. The syringe accessory device according to Implementation Scheme 14 or 15, wherein the distal portion of the tubular portion includes one or more latches extending from the inner surface of the tubular portion toward the central longitudinal axis of the tubular portion, the one or more latches being configured to provide traction when the barrel of the syringe is received in the proximal portion of the tubular portion.
[0169] Implementation Scheme 17. The syringe accessory according to any one of Implementation Schemes 1 to 16, wherein the single integral housing is configured to be fixedly attached to the barrel of the syringe when the barrel of the syringe is received in the tubular portion of the single integral housing.
[0170] Implementation Scheme 18. The syringe accessory according to any one of Implementation Schemes 1 to 17, wherein the single integral housing is configured to limit the depth of the needle when injected into the subcutaneous layer of the skin and / or when injected intramuscularly.
[0171] Implementation Scheme 19. The syringe accessory according to any one of Implementation Schemes 1 to 18, wherein the one or more flanges located at the proximal end of the tubular portion are larger than the one or more flanges of the syringe.
[0172] Implementation Scheme 20. The syringe accessory according to any one of Implementation Schemes 1 to 19, wherein the single integral housing comprises a transparent material, a translucent material, or an opaque material having one or more cutouts.
[0173] Implementation Scheme 21. The syringe accessory according to Implementation Scheme 20, wherein the material comprises polycarbonate, polypropylene, polyethylene, polyetheretherketone (PEEK), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), polyethylene terephthalate diol (PETG), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), or a mixture of polymers.
[0174] Implementation Scheme 22. A syringe assembly, the syringe assembly comprising: The syringe accessory according to any one of embodiments 1 to 21; and syringe.
[0175] Implementation Scheme 23. The syringe assembly according to Implementation Scheme 22, wherein the syringe includes a Luer locking needle or a Luer sliding needle coupled to the distal end of the barrel of the syringe.
[0176] Implementation Scheme 24. The syringe assembly according to Implementation Scheme 22 or 23, wherein, prior to use, the needle of the syringe is protected within a removable cap.
[0177] Implementation Scheme 25. The syringe assembly according to any one of Implementation Schemes 22 to 24, wherein the syringe is a pre-filled syringe containing an active pharmaceutical ingredient (API).
[0178] Implementation Scheme 26. A method for assembling a syringe and syringe accessories, the method comprising: Insert the syringe barrel into the proximal end of the tubular portion of the syringe accessory; and Advance the barrel toward the distal end of the tubular portion until one or more flanges of the syringe are engaged with one or more latches on the inner surface of the syringe accessory. The syringe accessory includes a single integral housing comprising: a tubular portion; one or more flanges located at the proximal end of the tubular portion; and a base portion located at the distal end of the tubular portion, the base portion extending outward from the outer surface of the tubular portion toward the end of the base portion in at least one direction to provide a stable contact surface at the injection site.
[0179] Implementation Scheme 27. The method according to Implementation Scheme 26, wherein the one or more latches are disposed at the proximal end of the tubular portion of the single integral housing such that the one or more latches prevent the syringe from retracting from the syringe accessory when the syringe barrel is advanced distally past the one or more latches.
[0180] Implementation Scheme 28. The method according to Implementation Scheme 28, wherein the one or more latches extend from the inner surface of the syringe accessory toward the central longitudinal axis of the tubular portion.
[0181] Implementation Scheme 29. The method according to any one of Implementation Schemes 26 to 28, wherein the one or more latches include one or more ribs, spring-loaded arms and / or one or more deformable tabs located on the inner surface of the tubular portion.
[0182] Implementation Scheme 30. The method according to any one of Implementation Schemes 26 to 29, wherein the single integral housing is fixedly attached to the barrel of the syringe when the barrel of the syringe is fully inserted into the tubular portion of the single integral housing.
[0183] Implementation Scheme 31. The method according to any one of Implementation Schemes 26 to 30, wherein the tubular portion includes a proximal portion and a distal portion, the proximal portion receiving the barrel of the syringe, and the distal portion shielding at least a portion of the needle of the syringe when the barrel is inserted into the proximal portion.
[0184] Implementation Scheme 32. The method according to Implementation Scheme 31, wherein the tubular portion includes a constriction portion located along the length of the tubular portion between the proximal portion and the distal portion to limit the protrusion of the needle when the barrel of the syringe is inserted into the proximal portion of the tubular portion.
[0185] Implementation Scheme 33. The method according to Implementation Scheme 31 or 32, wherein the distal portion of the tubular portion includes one or more latches extending from the inner surface of the tubular portion toward the central longitudinal axis of the tubular portion to provide traction when the barrel of the syringe is received in the proximal portion of the tubular portion.
[0186] Implementation Scheme 34. The method according to any one of Implementation Schemes 26 to 33, wherein the barrel of the syringe has a volume capacity between 0.1 mL and 70 mL.
[0187] Implementation Scheme 35. The method according to any one of Implementation Schemes 26 to 34, wherein the syringe is a 3mL syringe or a 5mL syringe.
[0188] Implementation Scheme 36. The method according to any one of Implementation Schemes 26 to 35, wherein the one or more flanges located at the proximal end of the tubular portion are larger than the one or more flanges of the syringe.
[0189] Implementation Scheme 37. The method according to any one of Implementation Schemes 26 to 36, wherein the syringe accessory is the single integral housing.
[0190] Implementation Scheme 38. A method for injecting an active pharmaceutical ingredient (API) contained in a syringe, the method comprising: The needle of the syringe is inserted into the injection site, the syringe being housed in a single integral housing, the single integral housing comprising: A tubular portion that receives the barrel of the syringe; One or more flanges, said one or more flanges being located at the proximal end of said tubular portion; and A base portion, located at the distal end of the tubular portion, extends outward from the outer surface of the tubular portion toward the end of the base portion in at least one direction to provide a stable contact surface at the injection site; as well as The API is injected at the injection site at the depth of the needle, which is limited by the single integral housing.
[0191] Implementation Scheme 39. The method according to Implementation Scheme 38, the method comprising inserting the syringe into the single integral housing.
[0192] Implementation Scheme 40. The method according to Implementation Scheme 38 or 39, wherein inserting the syringe comprises: advancing the syringe into the tubular portion until one or more flanges of the syringe contact one or more latches disposed on the inner surface of the one or more flanges of the single integral housing.
[0193] Implementation Scheme 41. The method according to Implementation Scheme 40, wherein, as the one or more flanges of the syringe are advanced distally past the one or more latches, the one or more latches clamp the one or more flanges of the syringe to prevent the syringe from retracting from the single integral housing.
[0194] Implementation Scheme 42. The method according to Implementation Scheme 40 or 41, wherein the one or more latches include one or more spring-loaded arms and / or one or more deformable tabs located on the inner surface of the tubular portion.
[0195] Implementation Scheme 43. The method according to any one of Implementation Schemes 38 to 42, wherein inserting the syringe comprises: advancing the syringe into the tubular portion until the one or more flanges of the syringe are received by one or more receiving portions of the one or more flanges of the single integral housing.
[0196] Implementation Scheme 44. The method according to any one of Implementation Schemes 38 to 43, wherein inserting the syringe comprises: advancing the syringe into the tubular portion until the distal end of the syringe barrel contacts a constricted portion along the length of the tubular portion.
[0197] Implementation Scheme 45. The method according to any one of Implementation Schemes 38 to 44, wherein inserting the needle into the injection site comprises: advancing the needle into the injection site until the end of the base portion providing the stable contact surface contacts the injection site.
[0198] Implementation Scheme 46. The method according to any one of Implementation Schemes 38 to 45, wherein when the base portion contacts the injection site, the base portion elevates a portion of the skin at the injection site located within the periphery of the base portion.
[0199] Implementation Scheme 47. The method according to any one of Implementation Schemes 38 to 46, wherein, during the injection of the API at the injection site, the single integral housing provides an injection angle between 85 degrees and 95 degrees relative to the contact surface.
[0200] Implementation Scheme 48. The method according to any one of Implementation Schemes 38 to 47, wherein the barrel of the syringe has a volume capacity between 0.1 mL and 70 mL.
[0201] Implementation Scheme 49. The method according to any one of Implementation Schemes 38 to 48, wherein the syringe is a 3mL syringe or a 5mL syringe.
[0202] Implementation Scheme 50. The method according to any one of Implementation Schemes 38 to 49, wherein, during the injection of the API at the injection site, the single integral housing restricts the depth of the needle to between 4 mm and 12 mm.
[0203] Implementation Scheme 51. The method according to any one of Implementation Schemes 38 to 50, wherein the tubular portion includes a proximal portion and a distal portion, the proximal portion receiving the barrel of the syringe, and the distal portion shielding at least a portion of the needle of the syringe when the barrel is received in the proximal portion.
[0204] Implementation Scheme 52. The method according to Implementation Scheme 51, wherein the distal portion of the tubular portion includes one or more latches extending from the inner surface of the tubular portion toward the central longitudinal axis of the tubular portion to provide traction when the barrel of the syringe is received in the proximal portion of the tubular portion.
[0205] Implementation Scheme 53. The method according to any one of Implementation Schemes 38 to 52, wherein the single integral housing is fixedly attached to the barrel of the syringe when the barrel of the syringe is fully inserted into the tubular portion of the single integral housing.
[0206] Implementation Scheme 54. The method according to any one of Implementation Schemes 38 to 53, wherein the single integral housing restricts the depth of the needle to the subcutaneous layer of the skin and / or intramuscular injection.
[0207] Implementation Scheme 55. The method according to any one of Implementation Schemes 38 to 54, wherein, when the barrel of the syringe is received in the tubular portion and the needle has not yet been inserted into the injection site, the single integral housing restricts the protrusion of the needle of the syringe.
[0208] Implementation Scheme 56. The method according to any one of Implementation Schemes 38 to 55, wherein the syringe is pre-loaded with the API.
[0209] Implementation Scheme 57. The method according to any one of Implementation Schemes 38 to 56, the method comprising loading the API into the syringe.
[0210] Implementation Scheme 58. The method according to any one of Implementation Schemes 38 to 57, wherein, prior to use, the needle is protected by a removable cap, and the method includes removing the cap from the needle.
[0211] Implementation Scheme 59. A syringe, the syringe comprising: A plunger, the plunger including a plunger stop located at a distal end of the plunger and a plunger rod extending from the plunger stop; and A single integral housing, the single integral housing comprising: A cylinder configured to receive the plunger rod; One or more flanges, said one or more flanges being located at the proximal end of the cylinder; and A base portion, located at the distal end of the barrel, extends outward from the outer surface of the barrel toward the end of the base portion in at least one direction, and the end of the base portion is configured to provide a stable contact surface at the injection site. The single integral housing is configured to limit the protrusion of the needle when the needle is attached to the distal end of the tube.
[0212] Implementation Scheme 60. The syringe according to Implementation Scheme 1, wherein the base portion has a cross-sectional dimension larger than the cross-sectional dimension of the barrel.
[0213] Implementation Scheme 61. The syringe according to Implementation Scheme 59 or 60, wherein the base portion includes a flared shape extending outward from the outer surface of the barrel toward the end of the base portion that provides the stable contact surface.
[0214] Implementation Scheme 62. The syringe according to any one of Implementation Schemes 59 to 61, wherein the base portion is configured to elevate a portion of the skin at the injection site located within the periphery of the base portion when the base portion contacts the injection site.
[0215] Implementation Scheme 63. The syringe according to any one of Implementation Schemes 59 to 62, wherein the single integral housing is configured to provide an injection angle between 85 degrees and 95 degrees relative to the contact surface.
[0216] Implementation Scheme 64. The syringe according to any one of Implementation Schemes 59 to 63, wherein the barrel has a volume capacity between 0.1 mL and 70 mL.
[0217] Implementation Scheme 65. The syringe according to any one of Implementation Schemes 59 to 64, wherein the syringe is a 3 mL syringe or a 5 mL syringe.
[0218] Implementation Scheme 66. The syringe according to any one of Implementation Schemes 59 to 65, wherein the single integral housing is configured to limit the protrusion of the needle to between 4 mm and 12 mm beyond the end of the base portion.
[0219] Implementation Scheme 67. The syringe according to any one of Implementation Schemes 59 to 66, wherein the syringe is for single use.
[0220] Implementation Scheme 68. The syringe according to any one of Implementation Schemes 59 to 67, wherein the syringe comprises the plunger and the single integral housing.
[0221] Implementation Scheme 69. The syringe according to any one of Implementation Schemes 59 to 68, wherein the single integral housing is configured to limit the depth of the needle when injected into the subcutaneous layer of the skin and / or when injected intramuscularly.
[0222] Implementation Scheme 70. The syringe according to any one of Implementation Schemes 59 to 69, wherein at least the single integral housing comprises a transparent material, a translucent material, or an opaque material.
[0223] Implementation Scheme 71. The syringe according to Implementation Scheme 70, wherein the material comprises polycarbonate, polypropylene, polyethylene, polyetheretherketone (PEEK), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), polyethylene terephthalate diol (PETG), acrylonitrile butadiene styrene (ABS), acrylonitrile styrene acrylate (ASA), or a mixture of polymers.
[0224] Implementation Scheme 72. The syringe according to any one of Implementation Schemes 59 to 71, wherein the distal end of the barrel is configured to be coupled to a Luer locking needle or a Luer sliding needle.
[0225] Implementation Scheme 73. The syringe according to Implementation Scheme 72, wherein, prior to use, the needle of the syringe is protected within a removable cap.
[0226] Implementation Scheme 74. The syringe according to any one of Implementation Schemes 59 to 73, wherein the syringe is a pre-filled syringe containing an active pharmaceutical ingredient (API).
[0227] Implementation Scheme 75. A method for injecting an active pharmaceutical ingredient (API) contained in a syringe, the method comprising: The needle of the syringe is inserted into the injection site, the syringe comprising: A plunger, the plunger including a plunger stop located at a distal end of the plunger and a plunger rod extending from the plunger stop; and A single integral housing, the single integral housing comprising: A cylinder that receives the plunger rod; One or more flanges, said one or more flanges being located at the proximal end of the cylinder; and A base portion, located at the distal end of the barrel, extending outward from the outer surface of the barrel toward the end of the base portion in at least one direction, the end of the base portion providing a stable contact surface at the injection site; and The API is injected at the injection site at the depth of the needle, which is limited by the single integral housing.
[0228] Implementation Scheme 76. The method according to Implementation Scheme 75, wherein inserting the needle into the injection site comprises: advancing the needle into the injection site until the end of the base portion providing the stable contact surface contacts the injection site.
[0229] Implementation Scheme 77. The method according to Implementation Scheme 75 or 76, wherein when the base portion contacts the injection site, the base portion elevates a portion of the skin at the injection site located within the periphery of the base portion.
[0230] Implementation Scheme 78. The method according to any one of Implementation Schemes 75 to 77, wherein, during the injection of the API at the injection site, the single integral housing provides an injection angle between 85 degrees and 95 degrees relative to the contact surface.
[0231] Implementation Scheme 79. The method according to any one of Implementation Schemes 75 to 78, wherein the cylinder has a volume capacity between 0.1 mL and 70 mL.
[0232] Implementation Scheme 80. The method according to any one of Implementation Schemes 75 to 79, wherein the syringe is a 3 mL syringe or a 5 mL syringe.
[0233] Implementation Scheme 81. The method according to any one of Implementation Schemes 75 to 80, wherein, during the injection of the API at the injection site, the single integral housing restricts the depth of the needle to between 4 mm and 12 mm.
[0234] Implementation Scheme 82. The method according to any one of Implementation Schemes 75 to 81, wherein the single integral housing restricts the depth of the needle to the subcutaneous layer of the skin and / or intramuscular injection.
[0235] Implementation Scheme 83. The method according to any one of Implementation Schemes 75 to 82, wherein the single integral housing restricts the protrusion of the needle of the syringe when the needle has not yet been inserted into the injection site.
[0236] Implementation Scheme 84. The method according to any one of Implementation Schemes 75 to 83, wherein the syringe is pre-loaded with the API.
[0237] Implementation Scheme 85. The method according to any one of Implementation Schemes 75 to 84, the method comprising loading the API into the syringe.
[0238] Implementation Scheme 86. The method according to any one of Implementation Schemes 75 to 85, wherein, prior to use, the needle is protected by a removable cap, and the method includes removing the cap from the needle.
[0239] Implementation Scheme 87. The syringe accessory according to any one of Implementation Schemes 1 to 25, the syringe accessory including a locking member disposed at the proximal end of the tubular portion and configured to retain the syringe within the tubular portion.
[0240] Implementation Scheme 88. The syringe accessory according to any one of Implementation Schemes 1 to 25, wherein the tubular portion includes an opening extending the length of the tubular portion and configured to receive the syringe, and the syringe accessory includes one or more retaining members disposed at a proximal end of the opening and configured to retain the syringe within the tubular portion.
[0241] Implementation Scheme 89. The syringe accessory according to any one of Implementation Schemes 1 to 25, wherein the tubular portion includes an opening extending the length of the tubular portion and configured to receive the syringe, and the syringe accessory includes a gate disposed along at least a portion of the length of the opening and configured to retain the syringe within the tubular portion.
[0242] Implementation Scheme 90. A syringe accessory according to any one of Implementation Schemes 1 to 25, 88 and 89, the syringe accessory comprising a slot disposed at the proximal end of the tubular portion and configured to receive the one or more flanges of the syringe.
Claims
1. A syringe accessory, comprising: A single integral housing, the single integral housing comprising: A tubular portion, the tubular portion being configured as a cylinder for receiving a syringe; One or more flanges, said one or more flanges at the proximal end of the tubular portion; and A base portion, located at the distal end of the tubular portion, extending outward from the outer surface of the tubular portion toward the end of the base portion in at least one direction, the end of the base portion being configured to provide a stable contact surface at the injection site. The single integral housing is configured to limit the protrusion of the syringe needle when the syringe barrel is received in the tubular portion.
2. The syringe accessory according to claim 1, wherein, The base portion has a larger cross-sectional dimension than the tubular portion.
3. The syringe accessory according to claim 1 or 2, wherein, The base portion is configured to elevate the skin portion of the injection site within the periphery of the base portion when the base portion contacts the injection site.
4. The syringe accessory according to any one of claims 1-3, wherein, The single integral housing is configured to provide an injection angle between 85 and 95 degrees relative to the contact surface.
5. The syringe accessory according to any one of claims 1-4, wherein, The single integral housing includes one or more latches disposed at the proximal end of the tubular portion and configured to clamp the syringe barrel as it is advanced distally past the one or more latches to prevent the syringe from retracting from the single integral housing.
6. The syringe accessory according to any one of claims 1-5, wherein, The syringe accessory is the single, integral housing.
7. The syringe accessory according to any one of claims 1-6, wherein, The tubular portion includes a constriction along the length of the tubular portion between a proximal portion and a distal portion of the tubular portion, the constriction being configured to restrict the needle from protruding from the distal portion when the barrel of the syringe is received in the proximal portion of the tubular portion.
8. The syringe accessory according to any one of claims 1-7, wherein, The one or more flanges at the proximal end of the tubular portion are larger than the one or more flanges of the syringe.
9. A syringe assembly, comprising: Syringe accessory according to any one of claims 1-8; and syringe.
10. The syringe assembly of claim 9, wherein, The syringe is a pre-filled syringe containing an active pharmaceutical ingredient (API).
11. A method for assembling a syringe and syringe accessories, comprising: Insert the syringe barrel into the proximal end of the tubular portion of the syringe accessory; as well as Advance the barrel toward the distal end of the tubular portion until one or more flanges of the syringe are engaged with one or more latches on the inner surface of the syringe accessory. The syringe accessory includes a single integral housing comprising a tubular portion, one or more flanges at the proximal end of the tubular portion, and a base portion at the distal end of the tubular portion, the base portion extending outward from the outer surface of the tubular portion toward the end of the base portion in at least one direction to provide a stable contact surface at the injection site.
12. The method according to claim 11, wherein, The one or more latches are disposed at the proximal end of the tubular portion of the single integral housing such that, as the syringe barrel is advanced distally past the one or more latches, the one or more latches prevent the syringe from retracting from the syringe accessory.
13. The method according to claim 11 or 12, wherein, The tubular portion includes a constriction along the length of the tubular portion between a proximal portion and a distal portion of the tubular portion to restrict the protrusion of the needle from the distal portion when the barrel of the syringe is inserted into the proximal portion of the tubular portion.
14. A syringe, comprising: A plunger, the plunger including a plunger stop at a distal end of the plunger and a plunger rod extending from the plunger stop; and A single, monolithic housing, comprising: A cylinder configured to receive the plunger rod; One or more flanges, said one or more flanges being located at the proximal end of the cylinder; and A base portion, located at the distal end of the barrel, extending outward from the outer surface of the barrel toward the end of the base portion in at least one direction, the end of the base portion being configured to provide a stable contact surface at the injection site. The single integral housing is configured to limit the protrusion of the needle when the needle is attached to the distal end of the tube.
15. The syringe according to claim 14, wherein, The base portion is configured to elevate the skin portion of the injection site within the periphery of the base portion when the base portion contacts the injection site.
16. The syringe according to claim 14 or 15, wherein, The single integral housing is configured to provide an injection angle between 85 and 95 degrees relative to the contact surface.
17. The syringe according to any one of claims 14-16, wherein, The syringe consists of the plunger and the single integral housing.
18. The syringe according to any one of claims 14-17, wherein, The syringe is a pre-filled syringe containing an active pharmaceutical ingredient (API).
19. The syringe accessory according to any one of claims 1-8, comprising a locking member disposed at the proximal end of the tubular portion and configured to retain the syringe within the tubular portion.
20. The syringe accessory according to any one of claims 1-8, wherein, The tubular portion includes an opening that extends the length of the tubular portion and is configured to receive the syringe, and the syringe accessory includes one or more retaining members disposed at a proximal end of the opening and configured to retain the syringe within the tubular portion.
21. The syringe accessory according to any one of claims 1-8, wherein, The tubular portion includes an opening that extends the length of the tubular portion and is configured to receive the syringe, and the syringe accessory includes a door that is disposed along at least a portion of the length of the opening and configured to retain the syringe within the tubular portion.
