Syringe assembly and method for filling a syringe with a drug

Abstract

A syringe assembly (10) includes a syringe barrel (12) having a proximal end and a distal end (16), a needle hub portion (20) coupled to the distal end of the syringe barrel. A guide member (30) extends from the needle hub portion (20) for sliding within an axial opening (76, 118, 132) of an adapter (32, 100, 130) connected to a container (36) or bottle containing a drug substance, medicine, or pharmaceutical. The guide member (30) has a shape and length that mates with the axial opening (76, 118, 132) in the adapter to guide the needle of the syringe straight through a septum (42) in the container, wherein the syringe can be filled and aspirated. In one embodiment, the guide member (30) has a plurality of radially extending ribs (52) that mate with complementary axial channels or grooves in the axial opening (76, 118, 132) of the adapter (32).

Description

Technical Field

[0001] The present invention relates to a syringe assembly that cooperates with an adapter. The adapter is configured to be connected to a bottle or container for filling and withdrawing a syringe. The present invention also relates to a syringe assembly having a guide member for guiding a needle through a septum in the bottle or container. The present invention also relates to a method for filling a syringe with a medicament. Background Art

[0002] Needles with lengths ranging from 4 mm to 5 mm are difficult to insert into containers or bottles and to aspirate due to their short length and the shape and size of the septum on the bottle's open end. The shorter length requires the needle to pierce the bottle's septum in a straight line to ensure penetration and reduce the risk of needle bending. The bottle's septum has a thickness that varies across its width. The septum is typically thicker at the outer edges to engage the inner surface of the bottle or container's neck. The center of the septum has a thinner area, which is more easily pierced by the needle for syringe filling.

[0003] Insertion of a needle into the patient's skin depends primarily on the characteristics of the needle rather than on the characteristics or structure of the needle support, as disclosed in Needle Insertion Modeling; Identifiability and Limitations, L. Barbe, Biomedical Signal Processing and Control 2 (207) 191-198. Needle insertion into the patient's skin is generally categorized into three stages that affect the depth of injection. The first stage corresponds to the initial contact of the needle with the skin, in which the tissue deforms without piercing the skin surface. The second stage refers to the puncture of the skin and the relaxation of the skin when the insertion force of the needle ceases. The third stage is the withdrawal of the needle and the pulling or stretching of the skin outward as the needle is withdrawn.

[0004] The needle length, for example, a needle having a length of about 4 mm to 5 mm, is suitable for injecting a medication to a specified target depth in the subcutaneous area. The present invention provides a structure so that the needle can be consistently inserted to the desired target depth. Existing pen needles have a cannula supported on an axial post extending from a seat. The axial post forms a narrow portion and a relatively wide base that does not contact the skin during injection. In other pen needles known in the art, the distal side of the seat that is placed against the injection site can be relatively large and can be provided with a slight taper at the edge. When the cannula is inserted at an angle relative to the patient's skin surface, the edge of the seat can engage the skin.

[0005] Various injection devices have been produced in which the support structure does not contact the skin during injection or retraction of the needle. Other devices have also been proposed in which the end face of the device is positioned to contact the skin surface to limit the depth of penetration into the patient's body.

[0006] Pen-type delivery devices facilitate the self-administration of injectable medications. A pen needle is a component of a needle-based injection system and consists of a double-ended cannula assembled into a plastic housing using adhesive. The housing has internal threads that allow it to be connected to the pen-type device. The pen-type attachment mechanism allows the proximal end of the cannula to penetrate the rubber septum of the medication cartridge to create a fluid flow path. For many people with diabetes, maintaining glycemic control is achieved by injecting insulin multiple times daily into the subcutaneous (SC) tissue using a pen-type delivery device, developed as a convenient and discreet alternative to bottles and syringes. Numerous pen-type delivery devices are commercially available in disposable or multi-use configurations, each offering a variety of patient-focused features. The distal pen-type cannula interfaces with the delivery site, providing a conduit for delivery. Pen needle design is designed to enable consistent delivery to the target tissue space, minimize leakage of the injectate, and reduce pain / discomfort and injection-related site effects such as bleeding and bruising. Key design features, needle length / gauge, and seating surface geometry combined with the mechanics of the delivery system and injection technique determine the success of the injection.

[0007] Injections can be performed in the intradermal, subcutaneous, and intramuscular (IM) regions of the skin. For many types of injectable medications, including insulin, the SC region is preferred for injection administration. See, for example, Lo Presti et al., Skin and subcutaneous thickness at injecting sites in children with diabetes: ultrasound findings and recommendations for giving injections, Pediatric Diabetes (2012).

[0008] While existing devices are generally suitable for their intended use, there remains a need for improved devices for filling and aspirating syringes for delivering medication or drugs to patients. Summary of the Invention

[0009] The present invention relates to a syringe assembly for piercing a septum in a bottle or other container containing a medication to reduce the risk of the syringe needle bending. The syringe assembly is configured to cooperate with an adapter connected to the container to facilitate filling and withdrawing the syringe. In one embodiment, the syringe assembly includes a guide member to orient the syringe and needle in a specific alignment relative to the bottle and septum during filling and withdrawing the syringe.

[0010] In one embodiment, a syringe assembly includes: a syringe barrel having a proximal end and a distal end; a needle hub portion coupled to the distal end of the syringe barrel; a needle extending axially from the needle hub portion; and an adapter configured to be coupled to a container, the adapter having an axial opening having a shape complementary to that of the needle hub portion and sized to receive the needle hub portion and the needle, wherein the adapter is configured to align the syringe barrel and the needle relative to the adapter when the needle is advanced to pierce a septum on the container.

[0011] In another embodiment, a syringe assembly includes: a syringe barrel having a proximal end and a distal end; a needle hub portion coupled to the distal end of the syringe barrel; a needle extending axially from the needle hub portion; a guide member extending from the distal end of the needle hub portion and having an outer surface with a non-circular configuration; and an adapter configured to couple to an open end of a container containing a medicament, the adapter having an axial opening having an inner surface having a configuration complementary to the outer surface of the guide member.

[0012] Syringe assemblies are primarily used with short needles having a length of about 4 mm to about 6 mm. Needles having a length of about 4 mm are desirable for certain applications, such as the delivery of insulin, where a 4 mm needle delivers insulin to a desired depth within the patient's body. Loading a syringe with a 4 mm needle requires careful insertion of the needle through the septum of a bottle containing insulin or other medication. The syringe assembly provides a mechanism whereby the needle can be inserted through the septum of a container in such a way that syringes can be loaded with needles of different lengths. The syringe assembly reduces the occurrence of bending or damage to the needle or septum puncture or provides for puncturing the septum at a position where the distal end of the needle is embedded in the septum and cannot contact the contents of the bottle or container.

[0013] The syringe assembly includes a syringe barrel having a needle extending from a needle hub, wherein the syringe barrel cooperates with an adapter that couples to a bottle. In one embodiment, the adapter has a distal end formed with a coupling member, such as one or more flexible legs. The legs flex outwardly to receive the neck of a bottle or container, thereby coupling the bottle or container to the adapter. The flexible legs have at least one, and typically multiple, ribs or detents to grip the neck of the container. The needle of the syringe passes through the adapter and into the container to load the syringe.

[0014] In one embodiment, a syringe assembly includes a guide member having an outer surface having a shape complementary to an opening in an adapter. The guide member and the adapter maintain constant alignment of the needle relative to the septum during insertion to reduce bending of the needle. The guide member generally has a non-circular outer surface and configuration. In other embodiments, the guide member and the opening of the adapter may have complementary circular cross-sectional profiles. The adapter has an axial opening having an inner surface substantially corresponding to the shape of the guide member, and the axial opening is typically non-circular. The complementary shapes of the guide member and the adapter provide a desired alignment of the needle with the septum of the container to facilitate piercing the septum and filling the syringe.

[0015] The syringe barrel has a distal end with a needle hub that supports the needle. The needle can have a length suitable for its intended use. In one embodiment, the needle has a length of approximately 4 mm. An adapter is configured to couple to the open end of a bottle or container and to receive the needle and needle hub. In one embodiment, the adapter has a guide surface for guiding the needle to a selected position on the septum of the bottle to ensure that the needle penetrates the cavity of the bottle, which can be filled with a syringe. In one embodiment, the adapter has an axial opening that centers the needle in the septum when the needle penetrates the septum.

[0016] The adapter has a coupling member, such as a collar having at least one, and typically multiple, axially extending legs, for coupling with a bottle or container during filling and aspirating the syringe. The legs include inwardly extending detents for engaging the neck of the bottle. The adapter is configured to align the needle with the septum of the bottle. The legs are flexible enough to snap onto the neck of the container to attach and detach the bottle from the adapter.

[0017] In one embodiment, a syringe assembly includes a guide member having a shape and configuration for coupling with an adapter. The guide member has a shape and configuration for stabilizing the needle and syringe when the needle pierces the septum of a vial. The guide member may have a non-circular shape that mates with an adapter having an axial opening having a non-circular shape that complements the shape of the guide member.

[0018] The guide member may have at least one, and typically a plurality, of radially extending ribs, wherein the opening in the adapter has at least one recess, groove, or channel for receiving the ribs on the guide member. The opening in the adapter has a shape and length that enables the guide member to slide into the opening in the adapter so that the needle can pierce the septum of the vial. The opening in the adapter has an axial length to stabilize the syringe and inhibit angular movement relative to the axis of the opening in the adapter.

[0019] These features are substantially achieved by providing a syringe assembly comprising a syringe barrel having a proximal end and a distal end, a needle hub coupled to the distal end of the syringe barrel, and an adapter for connecting to a bottle or container. The adapter is connected to the open end of the bottle and has an axial opening having a shape complementary to that of the distal end of the needle hub. The adapter is configured to support and guide the needle and the needle hub of the syringe barrel as the needle is advanced to pierce a septum on the bottle.

[0020] The syringe assembly is further characterized by a syringe barrel having a proximal end and a distal end, and a needle hub portion coupled to the distal end of the syringe barrel. The needle hub portion has a non-circular outer surface. An adapter is configured to couple to the open end of a vial containing a medication, wherein the adapter has an axial opening with an inner surface having a configuration complementary in shape and size to the non-circular needle hub portion.

[0021] A method for filling a syringe for injecting a medication into a subject is provided. The method includes providing a syringe assembly comprising a syringe barrel having a proximal end and a distal end, a needle hub coupled to the distal end of the syringe barrel, wherein the needle hub has a distal end with a non-circular configuration. An adapter is coupled to the open end of a bottle and has an axial opening. The distal end of the needle hub is guided through the open end of the adapter, wherein the needle pierces a septum on the bottle, and wherein the syringe can be filled with a substance from the bottle. The syringe is separated from the adapter, whereby the syringe is ready for use.

[0022] These and other features of the present invention will become apparent from the following detailed description of the invention, which, taken in conjunction with the annexed drawings, discloses various embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The following is a brief description of the accompanying drawings, in which:

[0024] Figure 1 is a perspective view of a syringe and adapter for attachment to a vial and for guiding the syringe and needle during aspiration in accordance with one embodiment of the present invention.

[0025] Figure 2 yes Figure 1 A perspective view of the adapter;

[0026] Figure 3 yes Figure 1 A top view of the adapter in an embodiment of the present invention;

[0027] Figure 4 It is along Figure 3 A cross-sectional view of the adapter taken along line 4-4;

[0028] Figure 5 is a cross-sectional side view of the assembly showing Figure 1 a needle that pierces the septum in the bottle in an embodiment of;

[0029] Figure 6 is a top view of an adapter in another embodiment;

[0030] Figure 7 It is along Figure 6 A partial cross-sectional side view of the adapter taken along line 7-7;

[0031] Figure 8 is a cross-sectional view of the assembly showing the needle piercing the septum;

[0032] Figure 9 is a perspective view of an adapter in yet another embodiment;

[0033] Figure 10 yes Figure 9 A top view of the adapter;

[0034] Figure 11 It shows Figure 9 a partial cross-sectional view of the guide surface of the adapter; and

[0035] Figure 12 It is along Figure 9 A cross-sectional view of the adapter taken along line 12-12. DETAILED DESCRIPTION

[0036] The syringe assembly of the present invention refers to a syringe having a needle or cannula for injecting a medication or other substance into a patient. The terms needle and cannula are used interchangeably herein to refer to a thin, tubular member having a pointed end for insertion into an injection site in a subject. The distal direction is toward the injection site, while the proximal direction is the opposite direction. The axial direction refers to a direction along or parallel to the longitudinal axis of the syringe needle and needle hub, while the radial direction refers to a direction perpendicular to the axial direction.

[0037] The dermal layer of an adult typically has a thickness of about 2 to 3 mm, allowing for an intradermal injection depth of up to about 3 mm, measured from the outer surface of the skin. The thickness of the subcutaneous layer varies depending on the patient's age, sex, body mass index (BMI), and the part of the body where the injection is being administered. The average thickness of the subcutaneous region is about 7 mm to about 15 mm. Insulin is preferably delivered to the subcutaneous region. Insulin injections are typically administered using a 4 mm needle.

[0038] The syringe assembly is suitable for use in methods for injection and for injecting a drug into a patient. The description of the embodiments should not be construed as limiting the invention. The disclosure is intended to enable a person of ordinary skill to implement the described variations of the invention without departing from the scope of the invention. The numerical limitations herein in the specification and claims are understood to be limited by the modifier "about" so that minor deviations that produce equivalent results are within the scope of the invention. Features disclosed in conjunction with one embodiment or independent claim or dependent claim limitations may be combined in another embodiment or in different independent claims without departing from the scope of the invention.

[0039] The present invention relates to a syringe assembly configured to be connected to a container, such as a bottle or other container containing medication, to facilitate filling and drawing the syringe. In the description of the embodiments, the terms bottle and container are used interchangeably to define a reservoir containing medication (e.g., insulin) for filling a syringe, wherein the syringe can be used to inject the medication into a patient. Referring to the accompanying drawings, the syringe assembly includes a syringe barrel 12 having a proximal end and a distal end 16. The proximal end receives a movable plunger and stopper for dispensing the substance contained in the syringe assembly in a typical manner. The syringe barrel and plunger have standard structures known in the art and are not shown for clarity. An adapter 32 is connected to a bottle 36, container, or other reservoir containing medication or other medication to facilitate drawing the syringe.

[0040] like Figure 1 As shown, a needle hub 20 is coupled to the distal end 16 of the syringe barrel 12. The needle hub 20 includes a needle 22 extending axially therefrom for dispensing the contents of the syringe barrel by depressing a plunger in a conventional manner. The needle hub 20 is configured for coupling to the distal end of the syringe barrel 12. The needle hub 20 has a generally cylindrical body having a proximal end 26. A distal end 28 faces axially outward for contacting a patient's skin surface during use.

[0041] The needle 22 in the illustrated embodiment has a length extending from the distal end of the syringe of approximately 4-6 mm, although the exposed length of the needle can vary depending on the specific needs of the syringe assembly. The syringe assembly described is primarily intended for use with shorter needle lengths, such as approximately 4 mm, which may make it more difficult to penetrate the septum of a vial than longer needle lengths. Shorter needle lengths may also make it difficult to penetrate the septum in a straight line to load the syringe. The needle 22 has a sharp distal tip and a lumen for communicating with the syringe barrel in a typical manner.

[0042] Reference Figure 1 The distal end 28 of the needle hub 20 includes a guide member 30 for cooperating with an adapter 32 to guide the needle through a septum 34 of a bottle 36 or other container containing a medication such as insulin. Figure 5 As shown, bottle 36 defines a container for storing medication until it is ready for use. Bottle 36 has an interior cavity 38 and a neck 40 with an outwardly protruding annular lip 42. A septum 34 fits into the open end of bottle 36 to seal it. The septum 34 has an annular collar 44 that extends into the neck 40 for friction-fit connection to the bottle. The collar 44 defines an interior space 47 that communicates with cavity 38 of the bottle 36. A top wall 46 with a flat outer surface contacts the top end of the neck 40. The top wall 46 has a thickness that enables the needle 22 to pierce the septum 34 and extend into the interior space of the collar 44 to load the syringe. A cap 45 is typically provided on the septum to secure it to the bottle. As shown, the cap 45 can be a metal film that is press-fit or crimped onto the septum to wrap around the lip of the bottle. Figure 5 The central open area of ​​the top surface of the cap shown in FIG. 3 exposes a portion of the top wall of the septum to enable a needle to pierce the septum 34 .

[0043] The hub portion 20 includes a guide member 30 extending axially from the distal end of the hub portion. The guide member 30 is shaped and configured to cooperate with the adapter 32 to guide the needle 22 through the septum 34 so that the end of the needle is positioned within the cavity 38 of the vial 36 for loading the syringe. The needle 22 can extend from the guide member 30 a distance to provide an exposed needle length suitable for injecting the medication to a desired depth into the patient's body. In the illustrated embodiment, the exposed needle length extending from the distal end of the guide member 30 is approximately 4 mm, although this length can be varied as desired.

[0044] Guide member 30 has an outer surface configured to cooperate with adapter 32 to control the angle and orientation of the needle and guide member relative to the bottle and the septum therein. Guide member 30 and adapter 32 have cooperating and complementary surfaces to center the needle within septum 34 so that the needle can properly penetrate the center of the septum and enter the interior space of annular collar 44 for filling the syringe. Needles 4 mm or less in length must penetrate the septum in a thin portion of the top wall (typically the center) to penetrate cavity 38 containing the medication. Guide member 30 and adapter 32 provide a mechanism for centering the needle within the septum and bottle and for guiding the needle along the central axis of septum 34 and annular collar 44 for filling the syringe. Guide member 30 and adapter 32 maintain axial alignment of the needle with the septum and resist angular movement of the needle relative to the central axis, which could cause the needle to bend or become misaligned with the lumen of the bottle.

[0045] In the illustrated embodiment, the guide member 30 has a non-circular outer surface for mating with the non-circular opening in the adapter 32. The guide member 30 can have a plurality of planar or curved surfaces that mate with corresponding surfaces in the axial opening 76 in the adapter 32. As shown, the guide member 30 has at least one rib 48 forming the non-circular outer surface. The guide member 30 typically has a plurality of ribs 48 spaced about the periphery of the guide member 30. In the illustrated embodiment, the guide member has four ribs 48 extending radially outward from the body of the guide member. The ribs 48 have a longitudinal length extending axially from the distal end of the needle hub portion 20 to provide a length sufficient to stabilize and guide the needle as it passes through the adapter, pierces the septum 34, and loads the syringe.

[0046] The ribs 48 have a substantially planar configuration having radial and longitudinal dimensions. The ribs 48 have distal surfaces 50 that form skin-contacting surfaces when the needle penetrates the skin surface to limit penetration depth and control skin distortion during penetration. The ribs 48 have radial outer surfaces 52 that extend the length of the respective ribs and extend longitudinally parallel to the axis of the needle hub and needle. In the illustrated embodiment, the ribs 48 have opposing parallel sides 54, wherein the sides of adjacent ribs converge at a central body 57 of the guide member 30. The ribs 48 in the illustrated embodiment form a guide member having a substantially X-shaped cross-section. As shown, the needle 22 extends axially from the guide member.

[0047] In one embodiment, guide member 30 is integrally formed with the distal end of needle hub 20. Ribs 48 and a central body 57 extend axially from the distal side of needle hub 20. Body 57 and needle hub 20 have an axial bore that receives needle 22. Guide member 30 can be secured to the needle and needle hub. Ribs 48 and central body 57 extend axially from the distal side of needle hub 20. Needle 22 extends through body 57 and the axial bore of needle hub 20 to communicate with the lumen of the syringe barrel for filling the syringe and delivering a substance or medication from the syringe to a patient.

[0048] In one embodiment, guide member 30 is a separate component that is removable from the needle and hub. The body 57 of guide member 30 has an axial bore sized to receive and slide over the needle 22. Guide member 30 can be slid onto needle 22 with the needle inserted through the axial bore until the proximal end of body 57 and rib 48 contact the distal end of hub 20, where the distal end of needle 22 extends from guide member 30. The size of the axial bore relative to the outer diameter of the needle allows the guide member to be retained on the needle by a friction fit. Guide member 30 can then guide the needle through the opening in adapter 32 for loading syringe 10. After syringe 10 is loaded, the needle is withdrawn from the vial. Guide member 30 can be detached from the needle by sliding away from it. Alternatively, guide member 30 can remain in place during use of the syringe to reduce the exposed length of the needle during use.

[0049] The adapter 32 is configured to attach to the open end of the bottle 36 and cooperate with the syringe and the guide member 30 extending from the needle hub. The adapter 32 has an open top end 56 and an open bottom end 58, and a coupling mechanism for coupling the adapter to the bottle 36. The open bottom end 58 has an internal cavity shaped and sized to couple with the top end of the bottle 36. The adapter 32 is shown as an integrally formed, one-piece member. The adapter can be made of a suitable material that can be coupled to the bottle to support the guide member and syringe when the needle penetrates the septum on the bottle. The adapter 32 can be made of a molded plastic material that is sufficiently flexible to attach to the bottle.

[0050] Adapter 32 has a generally circular shape, with a body 60 having a depending collar 62 defining an open bottom end 58. Collar 62 has a generally cylindrical shape with an outer surface 64 and an inner surface. A notch 66 is cut into the distal end of the bottom to form a leg 68. Leg 68 has an inwardly extending detent, shown surrounding the open bottom end 58 to define a lip 70 for coupling to a bottle. Lip 70 has an angled distal edge 72 for sliding onto lip 42 of bottle 36 and an angled proximal edge 74 for enabling separation of the adapter from the bottle lip. Leg 68 is resilient enough to snap onto the bottle lip for attaching and detaching the adapter from the bottle after use. The radial dimension of lip 70 is sufficient to engage the neck of bottle 36 and attach the adapter to the bottle when filling the syringe.

[0051] The outer surface of the body 60 includes an annular recess to aid the user in manipulating the adapter when attaching and detaching it from the bottle. The adapter 32 has an axial passageway defining an axial opening 76 and an inclined guide surface 78 for guiding the guide member 30 to the axial opening 76. The inclined guide surface 78 is formed in the first portion of the adapter, while the axial opening 76 is formed in the second portion of the adapter. In the illustrated embodiment, the guide surface 78 at the proximal tip 56 is in the form of a tapered surface that converges to the axial opening 76. The inclined guide surface 78 forms a self-centering feature, allowing the syringe needle and guide member 30 to pierce the center of the bottle's septum. The guide surface 78 and axial opening 76 are oriented to align with a selected location on the septum where the needle can access the bottle's contents. In the illustrated embodiment, the selected location on the septum is the area where the needle can pierce the septum to remove medication from the bottle. The central portion or area of ​​the septum is typically the thinnest portion, so the adapter and guide surface typically center the needle relative to the septum.

[0052] An axial opening 76 extends through the adapter 32 and has a shape and size complementary to that of the guide member 30 to enable the needle to pass through the septum and into the cavity of the bottle. The axial opening 76 has a non-circular shape that is complementary to the outer surface of the guide member 30. In the embodiment shown, the axial opening 76 has a substantially X-shape that corresponds to the cross-sectional shape of the ribs of the guide member.

[0053] See also Figure 3 and 4 The axial opening 76 is formed by an inwardly extending rib 80 having a substantially triangular cross-section. The rib 80 has a longitudinal dimension extending the axial length of the axial opening 76, as shown in FIG. Figure 4As shown. Each rib 80 has opposing side surfaces 82 oriented at substantially right angles to one another. The side surfaces 82 of adjacent ribs 80 are spaced apart to define a longitudinally extending channel 84 that forms the axial opening 76 and an X-shape corresponding to the cross-sectional shape of the guide member 30. The rib 80 has a bottom end surface that is aligned with the bottom surface of the body 60 of the adapter 32 and a top end surface 86 that is aligned with the bottom end of the inclined or chamfered guide surface 78. The top end of the rib 80 has an inclined, chamfered edge 87 that extends between the top end surface 86 and the side surfaces 82 to help guide the guide member into and through the axial opening 76. Figure 1-5 In the embodiment shown, the axial length of the axial opening 76 in the adapter is less than the axial length of the guide member 30, so that the guide member does not extend completely through the axial opening when inserted into the adapter and the adapter is seated on the septum 34. Figure 5 The guide surface 78 and the axial opening 76 are oriented to guide the needle to a selected location on the septum 34. In one embodiment, the axial opening 76 centers the syringe needle on the center of the septum, which is typically the thinnest portion of the septum.

[0054] During use of syringes and adapters, if Figure 5 As shown, the adapter 32 is attached to the open end of the bottle by sliding the open end of the adapter over the lip 42 of the bottle 36. Figure 5 As shown, the lip 70 on the leg 68 of the collar 62 snaps onto the neck 40 of the bottle. The collar 62 of the adapter 32 in the illustrated embodiment has an axial length where the bottom surface of the body 60 contacts the top surface of the septum 34 and an inner diameter substantially corresponding to the outer diameter of the lip 42 of the bottle 36. Figure 5 As shown, the syringe needle 22 and guide member 30 are inserted into the open top end of the adapter, with the needle passing through the axial opening 76 in the adapter 32 to pierce the septum 34. The open top end of the adapter assists the user in orienting the needle substantially perpendicular to the top surface of the septum and parallel to the axis of the annular collar 44 of the septum so that the needle enters the open cavity of the collar 44 to access the medication in the bottle. The guide member 30 is aligned with the axial opening 76 to slide therethrough, orienting the needle and syringe perpendicular to the axis of the bottle and orienting the needle at the center of the septum where it can pierce the septum to receive the contents of the bottle and fill the syringe in the conventional manner. Figure 5 In the embodiment shown, the axial length of the guide member 30 is greater than the axial length of the axial opening 76 so that the distal end of the guide member 30 contacts the top surface of the septum 34 when inserted into the adapter. Figure 5The syringe is inverted in the position shown in Figure 1 so that the contents of the bottle cover the lumen of the needle. The plunger is withdrawn to transfer the contents of the bottle into the syringe. Excess air can be aspirated into the bottle. The needle is separated from the bottle and the adapter, and the syringe is ready for use.

[0055] Figure 6-8 Another embodiment is shown in which an adapter 100 is similar to the previous embodiment and has a cylindrical body 112 and a collar 102 extending from the body 112. The collar 102 includes legs 106 for connecting to the open end of a bottle 108. As in the previous embodiment, an inwardly extending lip 110 is formed on the legs 106. The lip 110 has a radial dimension sufficient to grip the collar of the bottle 108. The lip 110 has an inclined distal surface 111 and an inclined proximal surface 113 to slide over the lip of the bottle 108. The adapter 100 is configured to use the syringe 10 and guide member 30 of the previous embodiment. The elements of the syringe and guide member are formed by Figure 1-5 The adapter 100 is configured to connect to the bottle 108 and cooperate with the syringe and guide member as in the previous embodiment. Figure 7 As shown, the inclined distal surface 111 and the inclined proximal surface 113 allow the lip 110 to slide onto the neck of the bottle 108.

[0056] The body 112 of the adapter 100 has a tapered recess 114 in the open top end of the adapter. An axial opening 116 extends axially through the body 112 to the cavity formed by the collar 102, as shown. Figure 7 Ribs 118 project inwardly from the inner surface of opening 116 to form an axially extending channel 119 and an X-shaped channel for receiving syringe 10 and guide member 30, as in the previous embodiment.

[0057] exist Figure 6-8 In the embodiment of FIG. 1 , the axial length of the axial opening 116 substantially corresponds to the axial length of the guide member 30 . Figure 8 The axial length of the axial opening 116 enables the distal end of the guide member 30 to contact the top end of the septum 120 of the bottle, wherein the distal end of the needle hub portion 20 contacts or is closely spaced from the tapered recess 114 of the open end of the adapter 100. Figure 6-8 In the embodiment shown, the axial length of the axial opening 116 is greater than the axial length of the guide member 30. Figure 1-5 In the embodiment. Figure 1-5 Compared to the embodiment in FIG. 1 , the angle of the tapered recess 114 is steeper and the axial depth of the axial opening 116 is smaller.

[0058] Figure 9-12Another embodiment of an adapter 130 for coupling to the open end of a bottle as in the previous embodiments is shown. Figure 9-12 In the embodiment of the present invention, the adapter 130 has an axial opening 132 having a shape for receiving the syringe 10 and the guide member extending from the syringe, as in the previous embodiment. The axial opening 132 has an inner surface having ribs 134 extending inwardly, the ribs being spaced apart from each other to form channels 136 between adjacent ribs 134, as shown in FIG. Figure 10 As shown. The guide member on the syringe will have a corresponding number of ribs so that each groove passes through the axial opening in a similar manner to the previous embodiment. In this embodiment, the guide member will have three ribs for cooperating with the three channels 136 in the axial opening 132.

[0059] As in the previous embodiment, the adapter 130 has a body 138 and a collar 140 extending from the bottom end of the body 138 for coupling to a bottle. The collar 140 is formed with flexible legs 142 having inwardly extending lips 144 for connecting to a bottle as in the previous embodiment.

[0060] The foregoing embodiments and advantages are exemplary and are not intended to be interpreted as limiting the scope of the present invention. The description of alternative embodiments is intended to illustrate, but not to limit the scope of the present invention. Various modifications, replacements, and variations are readily apparent to those skilled in the art and are intended to fall within the scope of the present invention. It is particularly noted that the features of different embodiments and claims may be combined with each other as long as they do not contradict each other. Therefore, all such modifications are intended to be included within the scope of the present invention as defined in the appended claims and their equivalents.

Claims

1. A syringe assembly comprising: a syringe barrel having a proximal end and a distal end; a needle hub portion coupled to the distal end of the syringe barrel; a needle extending axially from the needle hub; a guide member removable from the needle hub portion, the guide member extending in an axial direction from a distal end of the needle hub portion, the needle extending axially from the guide member, the guide member having at least one rib extending in a radial direction relative to the guide member; and an adapter configured to couple to a container, the adapter having an axial opening having a shape complementary to that of the hub portion and sized to receive the hub portion and the needle, wherein the adapter is configured to connect to the container and align the syringe barrel and the needle relative to the adapter when the needle is advanced to pierce a septum on the container, wherein the adapter comprises a first portion and a second portion, the first portion forming an inclined guide surface for guiding the guide member to the axial opening, the inclined guide surface having a top end and a bottom end, the top end having a width greater than a width of the bottom end, the second portion extending from the first portion and forming the axial opening, the second portion having an inner surface complementary to an outer surface of the guide member, and Therein, the inclined guide surface of the adapter is in the form of a tapered surface converging to the axial opening, the tapered surface forming a self-centering surface for centering the needle relative to the axial opening of the adapter.

2. The syringe assembly of claim 1, wherein: The adapter has a distal end with a coupling member for coupling with the container.

3. The syringe assembly of claim 2, wherein: The coupling member on the distal end of the adapter includes an inwardly extending detent configured to engage a lip of the container.

4. The syringe assembly of claim 1, wherein: The guide member includes a plurality of ribs extending axially relative to the guide member.

5. The syringe assembly of claim 4, wherein: The axial opening of the adapter has a plurality of axially extending channels that are complementary to corresponding ribs of the guide member.

6. The syringe assembly of claim 5, wherein: The channel has an axial length that is less than an axial length of the rib, and the rib and the guide member are axially slidable through the axial opening of the adapter.

7. The syringe assembly of claim 1, wherein: The guide member has a plurality of ribs extending in the axial direction relative to the guide member, and the adapter has a plurality of ribs, the plurality of ribs of the adapter extending radially inwardly into the axial opening of the adapter to define an axially extending channel for receiving the plurality of ribs of the guide member.

8. The syringe assembly of claim 7, wherein: Each of the plurality of ribs on the adapter has a top end with an inclined surface oriented for guiding the plurality of ribs of the guide member into the channel.

9. A syringe assembly comprising: a syringe barrel having a proximal end and a distal end; a needle hub portion coupled to the distal end of the syringe barrel; a needle extending axially from the needle hub; a removable guide member extending from a distal end of the hub portion and having an outer surface with a non-circular configuration; and an adapter configured for coupling to an open end of a container containing a medicament, the adapter having an axial opening with an inner surface having a configuration complementary to the outer surface of the guide member, wherein the adapter has a first portion and a second portion, the first portion forming an inclined guide surface for guiding the guide member to the axial opening, the inclined guide surface having a top end and a bottom end, the top end having a width greater than a width of the bottom end, the second portion extending from the first portion, the axial opening extending through the second portion, and Therein, the inclined guide surface of the adapter is in the form of a tapered surface converging to the axial opening, the tapered surface forming a self-centering surface for centering the needle relative to the axial opening of the adapter.

10. The syringe assembly of claim 9, wherein: The adapter has an axially extending collar forming a plurality of legs that are sufficiently flexible for coupling to the open end of the container.

11. The syringe assembly of claim 9, wherein: The guide member has at least one rib extending radially, and the axial opening of the adapter has a shape corresponding to that of the guide member.

12. The syringe assembly of claim 9, wherein: The guide member has a plurality of radially extending ribs, and the axial opening of the adapter has a shape corresponding to that of the guide member.

13. The syringe assembly of claim 12, wherein: The axial opening of the adapter has a plurality of radially extending ribs, the plurality of ribs of the axial opening defining a plurality of axially extending channels for receiving corresponding ribs of the guide member.

14. A method for filling a syringe with a drug, comprising: A syringe assembly is provided, the syringe assembly comprising: a syringe barrel having a proximal end and a distal end; a needle hub portion coupled to the distal end of the syringe barrel; a removable guide member extending from the distal end of the needle hub portion and having an outer surface with a non-circular configuration; a needle extending axially from the needle hub portion; and an adapter having an axial opening; connecting the adapter to an open end of a container containing a drug, the container having a septum; guiding the guide member through the axial opening of the adapter, piercing the septum on the container with the needle, and filling the syringe barrel with the medicament from the container; and Separate the syringe from the adapter, wherein the adapter comprises a first portion and a second portion, the first portion forming an inclined guide surface for guiding the guide member to the axial opening, the inclined guide surface having a top end and a bottom end, the top end having a width greater than a width of the bottom end, the second portion extending from the first portion and forming the axial opening, the second portion having an inner surface complementary to an outer surface of the guide member, and Therein, the inclined guide surface of the adapter is in the form of a tapered surface converging to the axial opening, the tapered surface forming a self-centering surface for centering the needle relative to the axial opening of the adapter.

15. The method according to claim 14, wherein The method further includes sliding the guide member and the needle through the axial opening of the adapter, whereby the needle pierces the septum on the container.

16. The method according to claim 15, wherein The guide member has a plurality of radially extending ribs defining the non-circular configuration, and the axial opening of the adapter has a plurality of inwardly extending ribs forming a plurality of axially extending channels for receiving corresponding ribs of the guide member.

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