Low dead volume adapter for a syringe

Abstract

An adapter (10) for a syringe (12) includes a shaft (36) having an internal cavity (46) and a seal (38). The shaft is sized and shaped to be inserted into an internal cavity (20) of a syringe tip (18) and form a seal with an opening (22) of the syringe tip, and the seal is sized and shaped to be inserted into a hub (26) and form a seal with the hub such that the adapter reduces the internal volume of the internal cavity of the syringe tip and the hub. Further, the adapter assembly includes an adapter and a delivery housing to which the adapter is attached, the syringe body includes the adapter, the needle assembly includes the adapter, and the syringe includes the adapter. Further, a method of reducing the dead volume of a syringe is provided in which the adapter as described above is disposed in the syringe.

Description

[0001] Cross - reference to Related Applications

[0002] This application claims priority to U.S. Patent Application No. 17 / 969,903, filed on October 20, 2022, entitled "Low Dead Volume Adaptor for a Syringe", the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Background of the Invention

[0004] Field of the Invention

[0005] The present invention relates to an adaptor for reducing the dead volume of a standard syringe, a syringe body including the adaptor, a needle hub including the adaptor, a syringe including the adaptor, and a method for reducing the dead volume of a syringe using the adaptor.

[0006] Description of the Related Art

[0007] Fittings and hubs for attaching a needle to a syringe body have been standardized, such as in ISO - 80369 - 7:2016, revised in 2021, entitled "Small - bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications". As can be seen from Figure 1, in such standard syringes (which use needle assemblies having hubs that fit onto male Luer cones), after using the syringe for injection, there are regions in the lumen of the Luer cone and in the needle hub that retain a large amount of drug. The drug in this volume, as well as the drug retained in the lumen of the needle, is referred to as the dead volume. Thus, standard syringes have a significant dead volume, which results in a large amount of drug being wasted with each injection and a reduced number of doses that can be obtained from a drug vial of a given volume, thereby increasing packaging and storage costs. For many high - value or rare drugs, this inadvertent drug waste can reduce access to the drug and / or increase costs.

[0008] Therefore, it would be advantageous to reduce the dead volume of standard syringes in order to reduce the amount of wasted drug and lower packaging and storage costs, especially when the drug must be refrigerated. Summary of the Invention

[0009] The present invention relates to an adapter for a syringe, the syringe having a syringe tip and a needle assembly, the syringe tip defining a lumen having an opening, and the needle assembly having a needle hub attached to the syringe tip. The adapter includes: a shaft having a proximal end, a distal end, and a sidewall extending between the proximal end and the distal end and defining a lumen extending through the shaft; and a seal extending from the distal end of the shaft. At least a portion of the shaft is sized and shaped to be inserted into the lumen of the syringe tip and form a seal with the opening of the syringe tip, and at least a portion of the seal is sized and shaped to be inserted into the needle hub of the needle assembly to form a seal with the inner surface of the needle hub, thereby reducing the internal volume of the lumen of the syringe tip and the internal volume of the needle hub, the internal volume of the lumen of the syringe tip and the internal volume of the needle hub being filled with a drug contained in the syringe.

[0010] The seal may surround the distal end of the shaft and have a proximal end, a distal end, and a sidewall. The outer surface of the sidewall of the seal may be tapered in the distal direction, wherein the maximum outer diameter of the seal is located at the proximal end of the seal and the minimum outer diameter of the seal is located at the distal end of the seal.

[0011] The seal may be a circumferential flange extending from the distal end of the shaft. The seal may have a concave curvature or the outer diameter of the seal may gradually decrease in the distal direction such that the maximum diameter of the seal is located at the proximal end of the seal, the minimum diameter of the seal is located at the distal end of the seal, and the seal extends in the proximal direction along the shaft. The seal may have a convex curvature or the outer diameter of the seal may gradually decrease in the proximal direction such that the maximum diameter of the seal is located at the distal end of the seal, the minimum diameter of the seal is located at the proximal end of the seal, and the seal extends away from the distal end of the shaft.

[0012] The shaft and / or the seal may be made of a material that compresses or bends when the shaft is inserted into the opening of the syringe tip or the seal is inserted into the needle hub.

[0013] The sealing surface of the seal may have a conical shape, a frustoconical shape, a hemispherical shape, or a cylindrical shape with a flat sealing surface at the front.

[0014] The diameter of the lumen of the shaft may vary along the length of the adapter. The distal portion of the lumen of the shaft is surrounded by the seal and is located in the needle hub, and the diameter of the distal portion may be larger than the diameter of the proximal portion of the shaft, the proximal portion being inserted into the lumen of the syringe tip.

[0015] The distal portion of the shaft is surrounded by the seal and is located within the needle hub, and the outer diameter of the distal portion is greater than the outer diameter of the proximal portion of the shaft, which is inserted into the lumen of the syringe tip.

[0016] The invention also relates to an adapter assembly comprising an adapter as described above and a delivery housing to which the adapter is attached.

[0017] The delivery housing may include an open proximal end, a closed distal end, and a sidewall extending between the proximal end and the distal end.

[0018] The diameter of the inner surface of the sidewall of the delivery housing at the closed distal end of the delivery housing is equal to or less than the maximum diameter of the seal such that the adapter is retained within the delivery housing by frictional and / or compressive forces between the inner surface of the sidewall of the delivery housing and the seal. The inner sidewall of the delivery housing may have a recess, the shape of which corresponds to the shape of the outer surface of the seal. The frictional and / or compressive forces between the adapter and the delivery housing may be less than the frictional and / or compressive forces between the adapter and the syringe tip.

[0019] A post may extend proximally and outwardly from the inner surface of the closed proximal end of the delivery housing and the post is inserted into the lumen of the shaft of the adapter, or a protrusion includes sidewalls defining a channel and the protrusion may extend proximally and outwardly from the inner surface of the closed proximal end of the delivery housing and the shaft of the adapter is inserted into the channel of the protrusion. The frictional and / or compressive forces between the adapter and the delivery housing may be less than the frictional and / or compressive forces between the shaft of the adapter and the post and between the shaft of the adapter and the protrusion.

[0020] A flange adapted to engage the threads of a Luer lock on the syringe may extend radially outwardly from the open distal end of the delivery housing, or the delivery housing may include threads on the inner surface of the sidewall.

[0021] The delivery housing may include ridges that extend radially outwardly from the outer surface of the sidewall.

[0022] The invention also relates to a syringe body comprising: a chamber having a syringe tip that defines a lumen with an opening through which a drug can be discharged from the chamber; and an adapter as described above. At least a portion of the shaft of the adapter is located within the lumen of the syringe tip and forms a seal with the opening of the lumen. The length of the shaft inserted into the lumen of the syringe tip may be substantially equal to the length of the lumen of the syringe tip.

[0023] The present invention also relates to a needle assembly, which includes: a needle hub having a sidewall that defines an internal volume; a needle having a lumen, the lumen of the needle being in fluid communication with the internal volume of the needle hub and extending from the needle hub; and an adapter as described above. The seal of the adapter is located in the internal volume of the needle hub and forms a seal with the inner surface of the sidewall of the needle hub.

[0024] The present invention also relates to a syringe, which includes: a syringe body including a chamber having a syringe tip that defines a lumen with an opening through which a drug can be discharged from the chamber; a needle hub having a sidewall that defines an internal volume connected to the syringe tip; a needle having a lumen, the lumen of the needle being in fluid communication with the internal volume of the needle hub and extending from the needle hub; and an adapter as described above. At least a portion of the shaft of the adapter is located in the lumen of the syringe tip and forms a seal with the opening of the lumen, the seal of the adapter is located in the internal volume of the needle hub and forms a seal with the inner surface of the sidewall of the needle hub, and the lumen of the shaft of the adapter is in fluid communication with the chamber and the lumen of the needle. At least a portion of the shaft of the adapter can fill a portion of the volume of the lumen of the syringe tip, and the seal of the adapter can fill and isolate a portion of the internal volume of the needle hub that would otherwise be filled with the drug. The length of the shaft inserted into the lumen of the syringe tip can be substantially equal to the length of the lumen of the syringe tip.

[0025] The present invention also relates to a method of reducing the dead volume of a syringe having a syringe tip and a needle assembly, the syringe tip defining a lumen with an opening, and the needle assembly having a needle hub attached to the syringe tip. The method includes providing an adapter as described above, inserting at least a portion of the shaft of the adapter into the lumen of the syringe tip, and inserting the seal of the adapter into the internal volume of the needle hub. A seal is provided between the shaft of the adapter and the opening of the syringe tip, and a seal is provided between the seal of the adapter and the inner surface of the needle hub. The adapter reduces the internal volume of the lumen of the syringe tip and the internal volume of the needle hub, and the internal volumes of the lumen of the syringe tip and the needle hub are filled with the drug contained in the syringe. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 is a cross-sectional view of the proximal end of a prior art syringe;

[0027] Figure 2 is a side view of a first embodiment of an adapter according to the present invention;

[0028] Figure 3 is Figure 2 a cross-sectional view of the adapter;

[0029] Figure 4 is a side view of a second embodiment of the adapter according to the present invention;

[0030] Figure 5 is Figure 4 a cross-sectional view of the adapter;

[0031] Figure 6 is a side view of a first embodiment of the adapter according to the present invention;

[0032] Figure 7 is Figure 6 a cross-sectional view of the adapter;

[0033] Figure 8 is a perspective view of the adapter housing according to the present invention;

[0034] Figure 9 is a cross-sectional view of a first embodiment of the adapter assembly according to the present invention, the adapter assembly having an adapter according to the present invention Figure 2 and Figure 3 of the adapter;

[0035] Figure 10 is according to the present invention Figure 9 a cross-sectional view of the adapter assembly, the adapter assembly having Figure 6 and Figure 7 of the adapter;

[0036] Figure 11 is a cross-sectional view of a second embodiment of the adapter assembly according to the present invention, the adapter assembly having Figure 4 and Figure 5 of the adapter;

[0037] Figure 12 is a cross-sectional view of a third embodiment of the adapter assembly according to the present invention, the adapter assembly having Figure 2 and Figure 3 of the adapter;

[0038] Figure 13 is a cross-sectional view of a fourth embodiment of the adapter assembly according to the present invention, the adapter assembly having Figure 2 and Figure 3 of the adapter;

[0039] Figures 14A to 14C is a cross-sectional view of the adapter according to the present invention, the adapter being inserted into the syringe body using the adapter assembly according to the present invention;

[0040] Figure 15 is having Figure 2 and Figure 3 a cross-sectional view of the proximal end of the syringe body of the present invention, the adapter of the present invention;

[0041] Figure 16 a cross-sectional view of the proximal end of the syringe of the present invention, which has the Figure 2 and Figure 3 present invention adapter; and

[0042] Figure 17 a cross-sectional view of the syringe body and the needle hub. DETAILED DESCRIPTION

[0043] As used herein, any numerical values are expressed using a period as the decimal point and a comma as the thousands separator. For example, 1,234 would be one thousand two hundred thirty-four, and 1.2 would be one and two tenths. Unless otherwise expressly specified, all numbers, such as those representing numerical values, ranges, amounts, or percentages, can be understood to begin with the word "about" even if the term does not explicitly appear. Any numerical range described herein is intended to include all sub-ranges subsumed therein. For example, a range of "1 to 10" is intended to include any and all sub-ranges (including 1 and 10) between the stated minimum value of 1 and the stated maximum value of 10, that is, all sub-ranges starting with a minimum value equal to or greater than 1 and ending with a maximum value equal to or less than 10, as well as all sub-ranges therebetween, such as 1 to 6.3, or 5.5 to 10, or 2.7 to 6.1. The plural includes the singular and vice versa. When ranges are given, any endpoints of these ranges and / or the numbers within these ranges can be combined within the scope of the present invention. The terms "comprising," "such as," "for example," and similar terms mean "including / such as / for example but not limited to."

[0044] Hereinafter, for purposes of description, the spatial orientation terms, such as "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," "proximal," "distal," and their derivatives, shall relate to the present invention in the orientation as depicted in the drawings, in the figures, or in the following detailed description. However, it should be understood that the embodiments described hereinafter may adopt many alternative variations and configurations. It should also be understood that the specific components, devices, features, and operating sequences shown in the drawings, in the figures, or otherwise described herein are merely exemplary and should not be considered restrictive.

[0045] As used herein, "proximal" refers to the end of the catheter adapter 10 and the direction indicated by the arrow "P" in the figure, while "distal" refers to the end of the catheter adapter 10 and the direction indicated by the arrow "D" in the figure.

[0046] The present invention relates to a low dead volume adapter for a syringe that may include a delivery housing ( Figures 8 to 14C ), a syringe body including the low dead volume adapter ( Figures 2 to 7 ), Figure 15) A needle hub including a low dead volume adapter ( Figure 16 ), and a syringe including a low dead volume adapter ( Figure 17 ).

[0047] Adapters 10, 10a, 10b are used with standard syringes and needle assemblies, for example, syringes compliant with ISO standards, or needle assemblies having connectors described in ISO - 80369 - 7:2016, revised in 2021, titled "Small - bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications". As shown in Figure 1, syringe 12 includes a syringe body 14 that defines a chamber 16 for containing a pharmaceutical composition and has a syringe tip 18 that has an inner lumen 20 with an opening 22 through which the pharmaceutical composition can be expelled from chamber 16. The syringe tip 18 can be, for example, a male Luer taper and can be surrounded by a threaded Luer lock 24. The syringe tip 18 is removably attached to the needle hub 26 of the needle assembly 28. The needle 30 has an inner lumen 32 that is in fluid communication with the internal volume 34 of the needle hub 26 and extends from the needle hub 26. A plunger rod (not shown) attached to a stopper (not shown) disposed within the chamber 16 of the syringe body 14 is movable relative to the syringe body 14 such that a distal force applied to the plunger rod while keeping the syringe body 14 stationary causes the stopper attached to the plunger rod to move distally within the chamber 16 of the syringe body 14, thereby expelling the pharmaceutical composition through the opening 22 of the syringe tip 18, the needle hub 26, and the inner lumen 32 of the needle 30.

[0048] At the end of an injection, when the stopper reaches the proximal end of the chamber 16 of the syringe body 14, no matter how much force is applied to the plunger rod and the stopper, the pharmaceutical composition remaining in the inner lumen 20 of the syringe tip 18 and the internal volume 34 of the needle hub 26 cannot be expelled from the syringe 12. This wasted pharmaceutical composition is commonly referred to as the "dead volume" of the syringe 12. Adapters 10, 10a, 10b are used to reduce the dead volume in standard syringes 12.

[0049] As Figures 2 to 7As described, the adapters 10, 10a, 10b include a shaft 36 and seals 38, 38a, 38b. The shaft 36 has a proximal end 40, a distal end 42, and a sidewall 44 that extends between the proximal end 40 and the distal end 42. The sidewall 44 defines a lumen 46 that extends through the shaft 36 such that both the proximal end 40 and the distal end 42 of the shaft 36 include openings. The shaft 36 can be generally cylindrical.

[0050] The seals 38, 38a, 38b extend from the distal end 42 of the shaft 36.

[0051] In Figure 2 and Figure 3 In one embodiment shown, the seal 38 surrounds the distal end 42 of the shaft 36 and has a proximal end 48, a distal end 50, and a sidewall 52. At the proximal end 48 of the seal 38, the outer diameter of the sidewall 52 of the seal 38 is greater than the outer diameter of the shaft 36 such that the proximal end 48 of the seal 38 defines a flange 54 that extends radially from the shaft 36. The outer surface 56 of the sidewall 52 of the seal 38 can be tapered in the distal direction, where the maximum outer diameter of the seal 38 is at the proximal end 48 of the seal 38 and the minimum outer diameter of the seal 38 is at the distal end 50 of the seal 38. In this embodiment, the seal 38 is plug-shaped. One or more circumferential ridges 58 can be provided on the sealing surface 60 of the seal 38.

[0052] In Figure 4 and Figure 5 In another embodiment shown, the seal 38a is a circumferential flange that extends from the distal end 42 of the shaft 36. The seal 38a can have a concave curvature, or the outer diameter of the seal 38a can gradually decrease in the distal direction such that the maximum diameter of the seal 38a is at the proximal end 48a of the seal 38a, the minimum diameter of the seal 38a is at the distal end 50a of the seal 38a, and the seal 38a extends along the shaft 36 in the proximal direction. In this embodiment, the adapter 10a is umbrella-shaped. One or more circumferential ridges 58 can be provided on the sealing surface 60a of the seal 38a.

[0053] In Figure 6 and Figure 7 In another embodiment shown, the seal 38b is a circumferential flange that extends from the distal end 42 of the shaft 36. The seal 38b can have a convex curvature, or the outer diameter of the seal 38b can gradually decrease in the proximal direction such that the maximum diameter of the seal 38b is at the distal end 50b of the seal 38b, the minimum diameter of the seal 38b is at the proximal end 48b of the seal 38b, and the seal 38b extends away from the distal end 42 of the shaft 36. In this embodiment, the adapter 10b has an inverted umbrella shape. One or more circumferential ridges 58 can be provided on the sealing surface 60b of the seal 38b.

[0054] Referring toFigures 14A to 14C , Figure 15 and Figure 17 , at least a portion of the shaft 36 of the adapters 10, 10a, 10b is sized to be inserted into the lumen 20 of the syringe tip 18. When the shaft 36 of the adapters 10, 10a, 10b is inserted into the lumen 20 of the syringe tip 18, the shaft of the adapter serves to reduce the drug-filled internal volume 62 of the syringe tip 18 while forming a seal with the opening 22 of the syringe tip 18, such that the drug contained within the syringe 12 is discharged through the lumen 46 of the shaft 36 of the adapters 10, 10a, 10b and prevents the drug from discharging between the opening 22 of the syringe tip 18 and the outer surface 64 of the shaft 36 of the adapters 10, 10a, 10b. The length L of the shaft 36 inserted into the lumen 20 of the syringe tip 18 S can be substantially equal to the length L of the lumen 20 of the syringe tip 18 t .

[0055] Referring Figure 16 and Figure 17 , the seals 38, 38a, 38b of the adapters 10, 10a, 10b are sized to be inserted into the needle hub 26 of the needle assembly 28 such that at least a portion of the sealing surfaces 60, 60a, 60b of the seals 38, 38a, 38b of the adapters 10, 10a, 10b sealingly engages at least a portion of the inner surface 66 of the sidewall 68 of the needle hub 26 of the needle assembly 28, and the lumen 46 of the shaft 36 of the adapters 10, 10a, 10b is in fluid communication with the lumen 32 of the needle 30. When the seals 38, 38a, 38b of the adapters 10, 10a, 10b are inserted into the needle hub 26 of the needle assembly 28, the seals of the adapter form a seal with the inner surface 66 of the sidewall 68 of the needle hub 26, such that the drug contained within the syringe 12 is discharged through the lumen 46 of the shaft 36 of the adapters 10, 10a, 10b and prevents the drug from flowing around the adapters 10, 10a, 10b and into the internal volume 62 of the needle hub 26. As a result, the adapters 10, 10a, 10b reduce the drug-filled internal volume 62 of the needle hub 26.

[0056] The shafts 36 of the adapters 10, 10a, 10b can be made of any suitable material that forms a fluid-tight seal with the opening 22 of the syringe tip 18. The material can be such that it compresses when the shafts 36 of the adapters 10, 10a, 10b are inserted into the opening 22 of the syringe tip 18, such as TPE, rubber, or a mixture of TPE and PE. The shafts 36 of the adapters 10, 10a, 10b can be retained within the opening 22 of the syringe tip 18 and form a seal with the opening 22 of the syringe tip 18 by friction and / or compressive force, and can have an outer diameter that is equal to or greater than the inner diameter of the opening 22 of the syringe tip 18.

[0057] The sealing surfaces 60, 60a, 60b of the seals 38, 38a, 38b of the adapters 10, 10a, 10b can have any shape that, together with the inner surface 66 of the side wall 68 of the needle hub 26 of the needle assembly 28, provides a fluid-tight seal. For example, the sealing surfaces 60, 60a, 60b of the seals 38, 38a, 38b of the adapter can have a conical shape, a frusto-conical shape, a hemispherical shape, or any other shape that the needle hub 26 can have. The seals 38, 38a, 38b of the adapters 10, 10a, 10b can be made of any suitable material that forms a fluid-tight seal with the inner surface 66 of the side wall 68 of the needle hub 26 of the needle assembly 28. The material can be such that it compresses or bends when the seals 38, 38a, 38b of the adapters 10, 10a, 10b are inserted into the needle hub 26 of the needle assembly 28, such as TPE, rubber, or a mixture of TPE and PE. The seals 38, 38a, 38b can be retained within the needle hub 26 of the needle assembly 28 and form a seal with the inner surface 66 of the side wall 68 of the needle hub 26 of the needle assembly 28 by friction and / or compressive force.

[0058] The lumen 46 of the shaft 36 of the adapters 10, 10a, 10b can have a constant diameter, or the diameter of the lumen 46 of the shaft 36 of the adapters 10, 10a, 10b can vary along the length of the adapters 10, 10a, 10b. For example, the distal portion 70 of the lumen 46 of the shaft 36 of the adapters 10, 10a, 10b is surrounded by the seals 38, 38a, 38b of the adapters 10, 10a, 10b and is positioned within the needle hub 26 of the needle assembly 28, and the diameter of this distal portion can be greater than the diameter of the proximal portion 72 of the shaft 36 of the adapters 10, 10a, 10b, which is inserted into the lumen 20 of the syringe tip 18.

[0059] The shafts 36 of the adapters 10, 10a, 10b may have a constant outer diameter, or the outer diameter of the shafts 36 of the adapters 10, 10a, 10b may vary along the length of the adapters 10, 10a, 10b. For example, the distal portion 74 of the shaft 36 of the adapters 10, 10a, 10b is surrounded by the seals 38, 38a, 38b of the adapters 10, 10a, 10b and is positioned within the needle hub 26 of the needle assembly 28, and the outer diameter of this distal portion may be greater than the outer diameter of the proximal portion 76 of the shaft 36 of the adapters 10, 10a, 10b, which proximal portion is inserted into the lumen 20 of the syringe tip 18.

[0060] As Figures 8 to 14C shown, delivery housings 78, 78a, 78b, 78c may be provided with the adapters 10, 10a, 10b to assist in inserting the adapters 10, 10a, 10b into the syringe tip 18 or the needle hub 26 and to prevent the adapters 10, 10a, 10b from being touched during insertion into the syringe tip 20 or the needle hub 26, thereby maintaining the sterility of the fluid path of the syringe 12. The delivery housings 78, 78a, 78b, 78c include an open proximal end 80, a closed distal end 82, and a sidewall 84 that extends between the open proximal end 80 and the closed distal end 82. The delivery housings 78, 78a, 78b, 78c may be substantially cylindrical.

[0061] For a delivery housing 78 ( Figures 9 to 11 ) adapted to insert the shaft 36 of the adapters 10, 10a, 10b into the syringe tip 18, the diameter of the inner surface 86 of the sidewall 84 at the closed distal end 82 of the delivery housing 78 may be equal to or less than the maximum diameter of the seals 38, 38a, 38b such that the adapters 10, 10a, 10b are retained within the delivery housing 78 by the frictional and / or compressive forces between the inner surface 86 of the sidewall 84 of the delivery housing 78 and the seals 38, 38a, 38b ( Figure 9 and Figure 10 ).

[0062] Alternatively, the inner surface 86 of the sidewall 84 of the delivery housing 78a may have a recess 88 that corresponds in shape to the outer surface 56 of the seals 38, 38a, 38b ( Figure 11 ). The recess 88 may optionally include a circumferential groove 90 for receiving optional circumferential ridges 58 on the sealing surfaces 60, 60a, 60b of the seals 38, 38a, 38b. The adapters 10, 10a, 10b are retained within the delivery housing 78a by the frictional and / or compressive forces between the recess 88 and the seals 38, 38a, 38b.

[0063] The seals 38, 38a are tapered distally or concave such that the maximum diameter of the seals 38, 38a is at the proximal ends 48, 48a of the seals 38, 38a, the minimum diameter of the seals 38, 38a is at the distal ends 50, 50a of the seals 38, 38a, and where the seals 38, 38a extend in the proximal direction along the axis 36, the recess 88 in the inner surface 86 of the sidewall 84 of the delivery housing 78a may have a similar shape, wherein the surface of the recess 88 is tapered distally such that the maximum diameter of the recess 88 is at the proximal end 92 of the recess 88, and the minimum diameter of the recess 88 is at the distal end 94 of the recess 88, adjacent the closed distal end 82 of the delivery housing 78a.

[0064] Optionally, a flange 96 adapted to engage the threads of the Luer lock 24 may extend radially outward from the open distal end 82 of the delivery housings 78, 78a.

[0065] In use, as Figures 14A to 14C shown, the delivery housings 78, 78a are pressed or screwed onto the syringe tip 18 until the axis 36 of the adapter 10, 10a, 10b has been inserted into the lumen 20 of the syringe tip 18 ( Figure 14B ). The frictional and / or compressive force between the adapter 10, 10a, 10b and the delivery housings 78, 78a is less than the frictional and / or compressive force between the axis 36 of the adapter 10, 10a, 10b and the opening 22 in the syringe tip 18 such that when the delivery housings 78, 78a are removed from the syringe tip 18, the adapter 10, 10a, 10b remains inserted in the opening 22 of the syringe tip 18 ( Figure 14C ).

[0066] When the syringe tip 18 includes a threaded Luer lock 24 and the delivery housing includes a flange 96 extending radially outward from the proximal end 80 of the delivery housings 78, 78a, the delivery housings 78, 78a are screwed into the Luer lock 24 to insert the axis 36 of the adapter 10, 10a, 10b into the lumen 20 of the syringe tip 18 and are then unscrewed from the Luer lock 24 after insertion.

[0067] For a delivery housing 78b ( Figure 12 and Figure 13 ) adapted to insert the seals 38, 38a, 38b of the adapter 10, 10a, 10b into the needle hub 26, a post 98 may extend proximally outward from the inner surface 100 of the closed proximal end 80 of the delivery housing 78b and the post 98 is inserted into the lumen 46 of the axis 36 of the adapter 10, 10a, 10b ( Figure 12)。The outer diameter of the post 98 can be equal to or greater than the diameter of the inner cavity 46 of the shaft 36 of the adapters 10, 10a, 10b such that the adapters 10, 10a, 10b are retained within the delivery housing 78b by frictional and / or compressive forces between the outer surface of the post 98 and the inner surface of the inner cavity 46 of the shaft 36.

[0068] Alternatively, the protrusion 102 includes a sidewall 104 that defines a channel 106, and the protrusion 102 can extend proximally outwardly from the inner surface 100 of the closed proximal end 80 of the delivery housing 78c, and the shaft 36 of the adapters 10, 10a, 10b is inserted into the channel 106 of the protrusion 102( Figure 13 )。The diameter of the channel 106 of the protrusion 102 can be equal to or less than the outer diameter of the shaft 36 of the adapters 10, 10a, 10b such that the adapters 10, 10a, 10b are retained within the delivery housing 78c by frictional and / or compressive forces between the inner surface of the sidewall 104 of the protrusion 102 and the outer surface of the sidewall 44 of the shaft 36.

[0069] Optionally, the delivery housings 78b, 78c can include threads 108 on the inner surface of the sidewalls 84 of the delivery housings 78b, 78c.

[0070] In use, the delivery housings 78b, 78c are pressed or screwed onto the needle hub 26 until the seals 38, 38a, 38b of the adapters 10, 10a, 10b have been inserted into the internal volume 62 of the needle hub 26 and are in sealing engagement with the inner surface 66 of the sidewall 68 of the needle hub 26. The frictional and / or compressive forces between the adapters 10, 10a, 10b and the delivery housings 78b, 78c are less than the frictional and / or compressive forces between the seals 38, 38a, 38b of the adapters 10, 10a, 10b and the inner surface 66 of the sidewall 68 of the needle hub 26 such that the adapters 10, 10a, 10b remain inserted into the needle hub 26 when the delivery housings 78b, 78c are removed from the needle hub 26.

[0071] When the delivery housings 78b, 78c include threads 108 on the inner surface 86 of the sidewalls 84 and the needle hub 26 includes a flange 110 that extends radially outwardly from the proximal end 106 of the needle hub 26, the needle hub 26 is screwed into the delivery housings 78b, 78c to insert the adapters 10, 10a, 10b into the needle hub 26 and is then unscrewed from the delivery housings 78b, 78c after insertion.

[0072] The seal 38b of the adapter 10b is a flange that has an outer surface 56 that is proximally tapered or convex in its initial position, i.e., in the case where the adapter 10b has an inverted umbrella shape, when the needle hub 26 is pressed or screwed into the needle hub 26, the seal collapses from its initial position to a position where the seal 38b has the opposite orientation such that the sealing surface 60b contacts the inner surface 66 of the sidewall 68 of the needle hub 26, and the seal 38b has a proximally tapered shape or a concave shape, i.e., the adapter 10b is in an umbrella shape.

[0073] Optionally, any one of the delivery housings 78, 78a, 78b, 78c can include a ridge 112 that extends radially outward from an outer surface 114 of a sidewall 84 of the delivery housing 78, 78a, 78b, 78c to assist a user in manipulating the delivery housing 78, 78a, 78b, 78c. The ridge 112 can extend longitudinally along the sidewall 84 of the delivery housing 78, 78a, 78b, 78c.

[0074] In use, as Figure 17 shown, after inserting the shaft 36 of the adapter 10, 10a, 10b into the lumen 20 of the syringe tip 18 and sealing it to the opening 22 of the syringe tip 18, or after inserting the seal 38, 38a, 38b of the adapter 10, 10a, 10b into the needle hub 26 and sealing it to the inner surface 66 of the sidewall 68 of the needle hub 26, then the syringe tip 20 is inserted and connected to the needle hub 26 such that the seal 38, 38a, 38b of the adapter 10, 10a, 10b is inserted into the needle hub 26 and sealed to the inner surface 66 of the sidewall 68 of the needle hub 28, or the shaft 36 of the adapter 10, 10a, 10b is inserted into the lumen 20 of the syringe tip 18 and sealed to the opening 22 of the syringe tip 20.

[0075] If the syringe tip 20 is provided with a threaded Luer lock 24 and the needle hub 26 is provided with a proximal flange 110, attaching the needle hub 26 to the syringe tip 20 by threadedly connecting the needle hub 26 to the syringe tip 18 causes the shaft 36 of the adapter 10, 10a, 10b to be inserted into the lumen 20 of the syringe tip 18 and sealed to the opening 22 of the syringe tip 18, or the seal 38, 38a, 38b of the adapter 10, 10a, 10b to be inserted into the needle hub 26 and sealed to the inner surface 66 of the sidewall 68 of the needle hub 26. Further tightening of the connection ensures a good seal is obtained between the shaft 36 of the adapter 10, 10a, 10b and the opening 22 of the syringe tip 18 and between the seal 38, 38a, 38b of the adapter 10, 10a, 10b and the inner surface 66 of the sidewall 68 of the needle hub 26, and ensures that the shaft 36 of the adapter 10, 10a, 10b extends into the syringe tip 18.

[0076] The adapters 10, 10a, 10b can be attached to any standard syringe 12 or provided with any standard syringe 12, such as an ISO Luer-compatible syringe. The adapter can be provided as a separate component and attached by medical staff during care to the syringe body 14 and the needle hub 26( Figures 2 to 7 ), the adapters 10, 10a, 10b can be attached to the syringe body 14 during the manufacturing process for subsequent attachment to the needle hub 26( Figure 15 ), attached to the needle hub 26 during the manufacturing process for subsequent attachment to the syringe body 14( Figure 16 ), or can be provided within the already assembled syringe body 14 and needle hub 26( Figure 17 ).

[0077] As can be seen from FIG. 1, for a standard syringe body 14 and a needle assembly 28 (the needle assembly having a needle hub 26 connected to the syringe tip 18 (Luer taper)), the internal volume 62 of the inner cavity 20 of the syringe tip 18 and the internal volume 34 of the needle hub 26 are large, such that after injection with the syringe 12, a large amount of the drug remains in these areas. The drug in this volume, as well as the drug remaining in the inner cavity 32 of the needle 30, is referred to as the "dead volume". The adapters 10, 10a, 10b of the present invention are applicable to conventional standard syringe bodies and needle assemblies to provide the beneficial effect of a low dead volume without the need to purchase a dedicated or specialized low dead volume device.

[0078] At least a portion of the shaft 36 of the adapters 10, 10a, 10b fills a portion of the internal volume 62 of the inner cavity 20 of the syringe tip 18, and the seals 38, 38a, 38b of the adapters 10, 10a, 10b fill and isolate a portion of the internal volume 34 of the needle hub 26 that would otherwise be filled with the drug, thereby reducing the dead volume of the standard syringe 12. By reducing the dead volume of the syringe 12, the adapters 10, 10a, 10b reduce the amount of wasted drug, thereby saving money and allowing for more injections to be provided by a given volume of drug.

[0079] Although specific aspects of the present invention have been described above for purposes of illustration, it will be apparent to those skilled in the art that various changes in the details of the invention can be made without departing from the invention.

Claims

1. An adapter for a syringe, the syringe having a syringe tip and a needle assembly, the syringe tip defining a lumen having an opening, the needle assembly having a needle hub attached to the syringe tip, the adapter comprising: a shaft having a proximal end, a distal end, and a sidewall extending between the proximal end and the distal end and defining a lumen extending through the shaft; and a seal extending from the distal end of the shaft, wherein at least a portion of the shaft is sized and shaped to be inserted into the lumen of the syringe tip and form a seal with the opening of the syringe tip, and at least a portion of the seal is sized and shaped to be inserted into the needle hub of the needle assembly to form a seal with the inner surface of the needle hub, thereby reducing the internal volume of the lumen of the syringe tip and the internal volume of the needle hub, the internal volumes of the lumen of the syringe tip and the needle hub being filled with a drug contained in the syringe.

2. The adapter according to claim 1, wherein The seal surrounds the distal end of the shaft and has a proximal end, a distal end, and a sidewall, and the outer surface of the sidewall of the seal is tapered in a distal direction, wherein the maximum outer diameter of the seal is located at the proximal end of the seal and the minimum outer diameter of the seal is located at the distal end of the seal.

3. The adapter according to claim 1, wherein, The seal is a circumferential flange extending from the distal end of the shaft.

4. The adapter according to claim 3, wherein, The seal has a concave curvature or the outer diameter of the seal gradually decreases in a distal direction such that the maximum diameter of the seal is located at the proximal end of the seal, the minimum diameter of the seal is located at the distal end of the seal, and the seal extends in a proximal direction along the shaft.

5. The adapter according to claim 1, wherein, The seal is a circumferential flange extending from the distal end of the shaft, the seal having a convex curvature or the outer diameter of the seal gradually decreases in a proximal direction such that the maximum diameter of the seal is located at the distal end of the seal, the minimum diameter of the seal is located at the proximal end of the seal, and the seal extends away from the distal end of the shaft.

6. The adapter according to claim 1, wherein, The shaft and / or the seal is made of a material that compresses when the shaft is inserted into the opening of the syringe tip or bends when the seal is inserted into the needle hub.

7. The adapter according to claim 1, wherein The sealing surface of the seal has a conical shape, a frustoconical shape, a hemispherical shape, or a cylindrical shape with a flat sealing surface at the front.

8. The adapter according to claim 1, wherein The diameter of the lumen of the shaft varies along the length of the adapter.

9. The adapter according to claim 7, wherein, The distal portion of the lumen of the shaft is surrounded by the seal and is located in the needle hub, and the diameter of the distal portion is greater than the diameter of the proximal portion of the shaft, the proximal portion being inserted into the lumen of the syringe tip.

10. The adapter according to claim 1, wherein, The distal portion of the shaft is surrounded by the seal and is located in the needle hub, and the outer diameter of the distal portion is greater than the outer diameter of the proximal portion of the shaft, the proximal portion being inserted into the lumen of the syringe tip.

11. An adapter assembly, the adapter assembly comprising: the adapter according to claim 1; and a delivery housing to which the adapter is attached, Wherein, the delivery housing includes an open proximal end, a closed distal end, and a sidewall extending between the proximal end and the distal end.

12. The adapter assembly according to claim 11, wherein, The diameter of the inner surface of the sidewall of the delivery housing at the closed distal end of the delivery housing is equal to or less than the maximum diameter of the seal, such that the adapter is retained within the delivery housing by frictional force and / or compressive force between the inner surface of the sidewall of the delivery housing and the seal.

13. The adapter assembly according to claim 12, wherein, The frictional force and / or compressive force between the adapter and the delivery housing is less than the frictional force and / or compressive force between the seal of the adapter and the inner surface of the sidewall of the needle hub.

14. The adapter assembly according to claim 11, wherein, The inner sidewall of the delivery housing has a recess, and the shape of the recess corresponds to the shape of the outer surface of the seal.

15. The adapter assembly according to claim 14, wherein, The frictional force and / or compressive force between the adapter and the delivery housing is less than the frictional force and / or compressive force between the seal of the adapter and the inner surface of the sidewall of the needle hub.

16. The adapter assembly according to claim 11, wherein, A post extends proximally and outwardly from the inner surface of the closed proximal end of the delivery housing, and the post is inserted into the lumen of the shaft of the adapter.

17. The adapter assembly according to claim 16, wherein, The frictional force and / or compressive force between the adapter and the delivery housing is less than the frictional force and / or compressive force between the shaft of the adapter and the post.

18. The adapter assembly according to claim 11, wherein, A protrusion extends proximally and outwardly from the inner surface of the closed proximal end of the delivery housing, the protrusion includes sidewalls defining a channel, and the shaft of the adapter is inserted into the channel of the protrusion.

19. The adapter assembly according to claim 18, wherein, The frictional force and / or compressive force between the adapter and the delivery housing is less than the frictional force and / or compressive force between the shaft of the adapter and the protrusion.

20. The adapter assembly according to claim 11, wherein, A flange adapted to engage the threads of the Luer lock on the syringe extends radially outwardly from the open distal end of the delivery housing.

21. The adapter assembly according to claim 11, wherein, The delivery housing includes threads on the inner surface of the sidewall.

22. The adapter assembly according to claim 11, wherein, The delivery housing includes a ridge that extends radially outwardly from the outer surface of the sidewall.

23. A syringe body, the syringe body comprising: A chamber having a syringe tip that defines an inner lumen with an opening through which a drug can be discharged from the chamber; And an adapter according to claim 1, Wherein at least a portion of the shaft of the adapter is positioned within the inner lumen of the syringe tip and forms a seal with the opening of the inner lumen.

24. The syringe body according to claim 23, wherein, The length of the shaft inserted into the inner lumen of the syringe tip is substantially equal to the length of the inner lumen of the syringe tip.

25. A needle assembly, the needle assembly comprising: A needle hub having a sidewall that defines an internal volume; A needle having an inner lumen that is in fluid communication with the internal volume of the needle hub and extends from the needle hub; And An adapter according to claim 1, Wherein the seal of the adapter is positioned within the internal volume of the needle hub and forms a seal with the inner surface of the sidewall of the needle hub.

26. A syringe, the syringe comprising: A syringe body, the syringe body including a chamber having a syringe tip that defines an inner lumen with an opening through which a drug can be discharged from the chamber; A needle hub, said needle hub having a side wall that defines an internal volume, and said internal volume being connected to the syringe tip; A needle, said needle having a lumen, the lumen of said needle being in fluid communication with the internal volume of said needle hub and extending from said needle hub; And The adapter according to claim 1, wherein at least a portion of the shaft of said adapter is positioned within the lumen of said syringe tip and forms a seal with the opening of said lumen, the seal of said adapter is positioned within the internal volume of said needle hub and forms a seal with the inner surface of the side wall of said needle hub, and the lumen of the shaft of said adapter is in fluid communication with said chamber and the lumen of said needle.

27. The syringe according to claim 26, wherein, At least a portion of the shaft of said adapter fills a portion of the volume of the lumen of said syringe tip, and the seal of said adapter fills and isolates a portion of the internal volume of said needle hub that would otherwise be filled with the drug.

28. The syringe according to claim 26, wherein, The length of the shaft inserted into the lumen of the syringe tip is substantially equal to the length of the lumen of the syringe tip.

29. A method for reducing the dead volume of a syringe, said syringe having a syringe tip and a needle assembly, said syringe tip defining a lumen having an opening, said needle assembly having a needle hub attached to said syringe tip, the method comprising: Providing an adapter according to claim 1; Inserting at least a portion of the shaft of said adapter into the lumen of said syringe tip; And Inserting the seal of said adapter into the internal volume of said needle hub, wherein a seal is provided between the shaft of said adapter and the opening of said syringe tip, and a seal is provided between the seal of said adapter and the inner surface of said needle hub, and said adapter reduces the internal volume of the lumen of said syringe tip and the internal volume of said needle hub, the internal volumes of the lumen of said syringe tip and the internal volume of said needle hub being filled with the drug contained in said syringe.

Images