KR101958042B1 - Liquid-transfer adapter beveled spike - Google Patents

Liquid-transfer adapter beveled spike Download PDF

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Publication number
KR101958042B1
KR101958042B1 KR1020147003621A KR20147003621A KR101958042B1 KR 101958042 B1 KR101958042 B1 KR 101958042B1 KR 1020147003621 A KR1020147003621 A KR 1020147003621A KR 20147003621 A KR20147003621 A KR 20147003621A KR 101958042 B1 KR101958042 B1 KR 101958042B1
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South Korea
Prior art keywords
liquid
vial
injector
spike
adapter
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KR1020147003621A
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Korean (ko)
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KR20140044910A (en
Inventor
줄리우스 씨. 선드
케빈 디. 스완슨
Original Assignee
안타레스 팔마, 인코퍼레이티드
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Priority claimed from US13/184,211 external-priority patent/US9220660B2/en
Application filed by 안타레스 팔마, 인코퍼레이티드 filed Critical 안타레스 팔마, 인코퍼레이티드
Publication of KR20140044910A publication Critical patent/KR20140044910A/en
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Publication of KR101958042B1 publication Critical patent/KR101958042B1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/10—Coring prevention means, e.g. for plug or septum piecing members

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

A liquid-delivery adapter is provided that can be operatively interposed between the injector and the vial. The liquid-delivery adapter includes an injector engagement portion configured to be fluidly coupled to the injector, and a vial engagement portion including a tip portion configured to puncture the septum of the vial and a spike having a spike axis. The tip portion includes a plurality of small surfaces facing each other at one or more edges and one or more edges are inclined with respect to the spike axis. The spikes are arranged without blocking the edges and form a channel that includes a channel opening formed in one or more of the surfaces and extends to be in fluid communication with the injector engagement portion.

Description

LIQUID-TRANSFER ADAPTER BEVELED SPIKE < RTI ID = 0.0 >

This application claims priority from U.S. Provisional Patent Application No. 61 / 671,037, filed July 12, 2012, and U.S. Patent Application No. 13 / 184,211, filed July 15, 2011, each of which is incorporated herein by reference. And it is part of this application.

The present invention generally relates to a liquid-delivery adapter, and specifically to a liquid-delivery adapter that provides liquid communication between the vial and the injector.

In the medical field, the medicament is typically provided in a vial. The drug is delivered from the vial to an injector (e.g., a syringe, a self-injector, a jet injector, etc.) during subsequent scans of the patient. In some cases, the drug is provided as a liquid solution in a sealed vial, while in other cases it is provided in a solid form (e.g., a powder). Generally, when a solid form is provided, a solvent (e.g., water) is injected into the vial to dissolve the drug. The drug is expelled from the vial into the injector for injection to the patient.

A typical vial is sealed with a stopper that may have a side wall extending below the inner wall of the neck portion of the vial. The sidewall geometry and thickness are not limited to powdered medicaments which require a solvent for dissolution and may depend on the nature of the medicament containing them. Typically, a hollow spike is used to fluidly communicate with the contents of the vial. In particular, the hollow spike punctures the stopper to drain and / or introduce liquid from the vial. However, when piercing the stopper, the spike 118 may be inadvertently introduced into the side wall of the stopper, thereby preventing and limiting liquid communication with the contents of the vial, depending on the orientation of the opening for introducing fluid into the spike from the vial.

In addition, as conventional spikes are pressed through the rubber stopper, the rubber stopper is usually stretched, bent, or severed by spikes. In some cases, a portion of the stopper may be introduced into the hollow spike, and even the stopper may be withdrawn to block liquid flow from the vial.

U.S. Patent No. 5,254,106 discloses a needle including a slot extending along a sidewall of a needle. Similarly, US 2006/0266431 discloses a needle having a slot in a side wall. U.S. Patent Nos. 4,411,661 and 2007/0179506 disclose spikes having slots extending from a conical tip on a sidewall. U.S. Patent No. 7,150,735 discloses spikes having one or more openings in inclined surfaces. All patent documents are incorporated herein by reference in their entirety.

U.S. Patent No. 5,254,106 discloses a needle including a slot extending along a sidewall of a needle. Similarly, U.S. Patent Publication No. 2006/0266431 discloses a needle including a slot within a side wall. U.S. Patent No. 4,411,661 and U.S. Patent Publication 2007/0179506 disclose spikes having slots extending from a conical tip on a sidewall. U.S. Patent No. 7,150,735 discloses spikes having one or more openings in inclined surfaces. All patent documents are incorporated herein by reference in their entirety.

A liquid-delivery adapter is provided that can be operatively interposed between the injector and the vial. In some embodiments, the liquid-delivery adapter includes an injector engagement portion configured to be fluidly coupled to the injector, and a vial engagement portion. The vial attachment includes a tip and a spike having a spike axis configured to puncture the septum of the vial. The tip portion includes a plurality of small surfaces facing each other at one or more edges and one or more edges are inclined with respect to the spike axis. The spikes are arranged without blocking the edges and form a channel that includes a channel opening formed in one or more of the surfaces and extends to be in fluid communication with the injector engagement portion.

In some embodiments, the edge includes a bond between the faces. The edge may also include a cutting surface configured to cut the septum as the spike is pressed through the septum. In one embodiment, the tip portion comprises three or more surfaces and the channel opening comprises a channel opening arranged in three or more respective surface planes. The channel opening may be circumferentially spaced from the edge. Additionally, the transverse edge of the channel opening can be arranged radially inward relative to the edge. In addition, the transverse edge of the channel opening is arranged radially inward relative to the edge at any axial location. The transverse edge of the channel opening may be spaced sufficiently away from the edge to minimize introduction of the septum into the channel opening when the spike penetrates the septum. The channel opening may be centered substantially circumferentially on the surface.

In some embodiments, the seal can be arranged in the injector coupled portion configured to match the injector and the injector or inserter for retaining liquid in the channel. In addition, the injector engagement portion has a dimension suitable for engagement with a needleless injector. In addition, the removable insert can be releasably coupled within the injector engagement portion to selectively configure the injector engagement portion to engage the injector of various sizes. The removable insert comprises a dimension suitable for engagement with a syringe having a first width and wherein the injector engaging portion is configured to engage a jet injector having a second width greater than the first width with the insert removed.

In some embodiments, the vial engaging member may be associated with a vial engaging portion configured to engage the liquid-transfer adapter with the vial while the spike is inserted into the vial. In addition, the vial-engaging member may include a reflexed finger extending toward the spike and arranged around the spike to hold and snap-fit the liquid-transfer adapter coupled to the vial. Additionally, the spike may include a shaft extending from the tip toward the injector engagement portion, the opening extending onto the shaft to maximize fluid drainage from the vial with the vial in an inverted position.

In some embodiments, the edge meets at a point substantially in the axial center. Additionally, the surface can be a substantially flat slope. In another embodiment, a liquid-delivery adapter is provided having a spike for providing liquid communication with the sealed vial. The spike includes a piercing portion and a shaft portion configured to puncture the septum of the vial. The tip includes three or more slopes coupled together at a substantially centrally located tip, a channel extending through the spike, and a channel opening disposed on the shaft portion and in each of the slopes. The channel opening is connected to the channel for transferring fluid from or to the vial.

In some embodiments, the present invention includes a liquid-delivery adapter operably interposed between an injector and a vial, the liquid-delivery adapter having an injector engagement portion configured to fluidly couple to the injector, to pierce the septum of the vial Wherein the vial engaging portion including a tip portion and a spike having a spike axis includes a plurality of small surfaces facing each other at one or more edges and one or more edges are inclined with respect to the spike axis and the spike is arranged without blocking the edge, And forming a channel extending in fluid communication with the injector mating portion and a vial configured to function as a guide for coupling the liquid-delivery adapter to the vial with the spike inserted into the vial Including collars and associated colors All.

1 illustrates a liquid-delivery system 100 in accordance with an embodiment of the present invention.
FIG. 2 is a cross-sectional view of the liquid-delivery system 100 of FIG. 1 taken along line II-II.
3 is a cross-sectional view of a distal portion of the distal end of the liquid-delivery adapter of Fig. 2 coupled to vial 102. Fig.
Figures 4 and 5 show the vial 102 after and before sealing with the stopper 120;
Figures 6 to 8 are cross-sectional views of various adapters configured to be connected to vials of various sizes for liquid-transfer.
Figure 9 is a perspective view of the liquid-delivery adapter 104 of Figure 1;
10 is an enlarged cross-sectional view of the liquid-delivery adapter taken along line XX;
Figure 11 is an axial view of the liquid-delivery adapter 104 of Figure 9 from the vial engaging portion.
12 is a side view of the liquid-delivery adapter 104 of Fig. 1 with a cap prior to using the adapter; Fig.
FIG. 13 is a cross-sectional view of the liquid-delivery adapter 104 shown in FIG. 12 taken along line XIV.
14-17 illustrate steps of an embodiment of a method for introducing liquid into a vial using a removable insert and a liquid-delivery adapter 104;
18 is a perspective view of an embodiment of a spike 118 puncturing a septum of a vial.
Figures 19 and 20 are axial views of the spikes of Figure 18, partially and completely perforated through the septum 120 of the vial 102, respectively.
21 illustrates a spike having four sub-planes in accordance with an alternative embodiment;
22 is a perspective view of an exemplary embodiment of a liquid-delivery adapter 200;

Referring to Figure 1, a liquid-transfer system 100 is illustrated in accordance with an exemplary embodiment. In one embodiment, the liquid-delivery system 100 includes a vial 102 holding a liquid 103, a liquid-delivery adapter 104, and an injector 106. In another embodiment, a liquid-delivery adapter 104 may be coupled to the vial 102 to assist delivery of liquid from and / or to the injector 106 and / or vial 102 and / And injector (106).

The injector 106 may have an indicator window 108 for indicating the volume of liquid 103 that the injector receives from the vial 102 (e.g., the liquid withdrawn from the vial 102) . The injector 106 may take one of several different forms including an injector, an automatic injector, or a jet injector (with or without needles). Information about injectors can be found in U.S. Patent Nos. 5,875,976 and / or 6,673,035, which are incorporated herein by reference in their entirety. It is to be understood that needle-free injectors described in these documents may be suitable for needle-assisted infusion, automatic infusion and / or other types of infusions.

A liquid-delivery adapter 104 may be operably coupled between the vial 102 and the injector 106. The liquid-delivery adapter 104 has a vial engagement end 110 that couples the vial with the liquid-delivery adapter 104 and receives the vial 102. Additionally, the liquid-delivery adapter 104 has an injector mating end 112 to which the injector 106 may be attached.

Figure 2 is a cross-sectional view of the liquid-delivery system of Figure 1 taken along line II-II. As shown, the injector 106 includes a distal housing 107 and a proximal housing 109. The proximal housing 109 includes a trigger 113 and a button 113 for pushing the injector 106. The distal housing 107 includes an energy source 17 (e.g., a firing spring) and a ram 115 associated therewith to provide energy for pressing the injector 106. A firing stopper 119 may be attached to the distal end of the ram 115 to eject fluid medication through the jet nozzle 121 when the injector 106 is pushed. In addition, the firing stopper 119 moves in the proximal direction to inject the liquid 103 from the vial 102 into the cartridge 123. The seal is in contact with the jet nozzle 121 of the cartridge 123 and is generally located between the proximal end of the injector 106 and the liquid-delivery adapter 104. The seal 132 may retain liquid in the injector 106 and channel 130 coupled to the liquid-delivery adapter 104.

3 is an enlarged view of a portion of FIG. 2 showing liquid-delivery adapter 104 and vial 102. FIG. In one embodiment, the vial 102 includes a radially projecting lip (not shown) that extends beyond the neck 125 and a concave portion of the neck 127 that may be used to couple the vial 102 to the liquid- 114). The fingers 116 of the liquid-delivery adapter 104 may be provided to engage and seat on the lip 114 to retain the vial 102 in a position coupled to the liquid- . The fingers 116 may be arranged around the spike 118 to hold the liquid-transfer adapter 104 coupled to the vial 102 and extend toward it for snap-fitting.

The spikes 118 of the liquid-delivery adapter 104 in accordance with the combination of the liquid-delivery adapter 104 and the vial 102 puncture the septum 700 (shown in FIG. 4) of the vial 102. In one embodiment, the spike 118 may be a spike having a plurality of facets with a tip 122 that is axially centered with respect to the central axis of the spike 118. In this embodiment, the tip 122 may have a coaxial point, but in an alternative embodiment the tip and the point may be off center. The one or more surfaces 124 may include a channel opening 126. Some or all of the channel openings 126 extend over the sidewalls 128 of the shaft 129 of the spikes 118 and on the surface 124. As the spike 118 is pushed through the septum 700, the septum is deformed (as shown at 117) as the side wall 128 of the shaft 129 is pressed over the septum. In one embodiment, the channel opening 126 extends below the side wall 128 of the shaft 129 so that the spike 118 is inserted through the septum 700 and thus does not extend past the septum 700 Any liquid that flows into the gap 147 along at least a portion of the channel opening 126 has an access to at least a portion of the channel opening 126. The channel opening 126 is fluidly connected to the inner channel 130 extending longitudinally through the spike 118 thereof. The channel opening 126 is generally circumferentially spaced from the edge 190 (FIG. 11). In addition, the transverse edges of the channel openings 126 are arranged radially inwardly from the edge 10 at any axial station. The channel 130 provides liquid communication between the injector mating end 112 of the liquid-delivery adapter 104 and the vial mating end 110.

2 and 3 also illustrate a fluid delivery system 100 that is configured to prevent fluid from leaking out of the interface between, for example, the associated injector 106 and the injector mating end 112 and within the injector mating end 112 over the distal end of the channel 130 Seal 132, such as a rubber seal or an elastomeric septum, is shown. The seal 132 includes an opening 133 for fluidly communicating the channel 130 with the injector 106. Sealing portion 132 includes a dome-shaped region 135 that cooperates with dome cutaway 137 in liquid-delivery adapter 104 to assist in forming the seal. In one embodiment, the jet nozzle 121 somewhat deforms the seal 132 during bonding.

4 shows the vial 102 prior to being seated according to the stopper 120. FIG. The vial 102 has a lip 114 and a concave neck portion 127. The medicament may be inserted into the vial 102 prior to placing the stopper in the neck 125 of the vial. The stopper 120 may include a stopper sidewall 145 configured to extend into the neck 125 of the vial. Before sealing the vial 102, the stopper 120 may be partially inserted into the vial 102 forming the gap 147 of the stopper sidewall 145. The spacing 147 may take the form of a hollow portion of the stopper 120 or a shortened portion of the stopper sidewall 145. The drug may be arranged in the vial in liquid or solid form. Additionally, in some embodiments, the liquid medicament inserted into the vial 102 may be heated before the stopper 120 is fully inserted, or otherwise treated as being solid. 5, when the stopper 120 is fully inserted into the vial 102, a cap 149 (e.g., a metal cap) is arranged over the stopper 120, And then crimped around the lip 114 of the vial 102 to seal the stopper 120 and secure it. The cap 149 includes a detachable tab 153 that can be removed for insertion of the spike, such as the spike 118 of the liquid-delivery adapter 104. The stopper 120 may be provided on top thereof with a circular protrusion 151 that may be provided to provide a target for spikes. The detachable tab 153 may, in some embodiments, be generally centered over the projection 151, thereby exposing the projection 151 upon removal. The stopper 120 and / or vial 102 may be provided in different sizes and / or dimensions.

6 to 8 and 10 show cross-sectional views of a liquid-delivery adapter 104 having a vial 102 including an exemplary stopper having a different dimension, respectively. 6 shows a 20 mm diameter vial lip stopper 155, an alternative 20 mm diameter vial lip stopper 157 is shown in FIG. 7, and a 13 mm diameter vial lip stopper 159 are shown. Each stopper 155, 157, 159 has an interval 161, 163, 165, respectively. The spikes 118 may have the same dimensions in a sized liquid-delivery adapter for use with different vials as in the respective adapter in Figs. 6-8. The common mold can be used for spikes 118 having various vial and stopper sizes and functioning within a variety of adapters. As such, the mold for the other portion of the liquid-delivery adapter 104 can change, but a single mold needs to be manufactured and designed for the spike 118 in this embodiment, .

6 through 8, the channel opening 126 of the spike 118 in this embodiment is such that a portion of the channel opening 126 is sufficiently tapered to extend beyond the septum 700 (not shown) From the surface 124 to the spike sidewall 128 at a distance from the surface 123. [ In some embodiments, at least a portion of the channel opening 126 is retained in the stopper 155, 157 or 159 and a portion of the channel opening 126 is spaced apart (e.g., spaced 161, 163, 165) Lt; / RTI > In another embodiment, at least a portion of the channel opening 126 is arranged flush with the septum 700. In another embodiment, the proximal portion of the channel opening 126 does not extend completely through the septum 700 and into the space. It should be understood that there may be some deformation of the stoppers (e.g., 155, 157, 159) at the center portion when the spike 118 is pushed through as shown in FIG. This modification is not shown in Figs. However, channel opening 126 of spike 118 generally terminates at some point within the central portion of the septum, and thus the combined vial, liquid-delivery adapter 104, and injector are inserted with the vial at the top, The stopper sidewall 145 and the stopper sidewall 145 are spaced apart from each other. In an alternative embodiment, however, some or all of the channel openings 126 may be shortened to remain spaced from the stopper sidewalls 145 when the spike 118 is fully inserted therein.

4 and 5, the degree and / or degree with which a portion of the channel opening 126 is disposed within, or in sealing engagement with, or within the stopper 120 is determined by the distance between the end 140 of the channel opening 126, Such as the thickness of the stopper 120, the length of the channel, and / or the extent to which the channel extends below the sidewalls of the spike. However, it should be understood that in certain embodiments, the dimensions of the spikes 118 are such that they are configured to function as intended for septum / stoppers and / or vials of various dimensions. As such, the tool for spike 118 can be reused. The dimensions of the liquid-delivery adapter 104 may vary, for example, to accommodate vial necks of different sizes. In other embodiments, the dimensions of the spikes 118 may vary and the tool may be configured to accommodate various spike sized dimensions.

Figure 9 is a perspective view of the vial-free liquid-delivery adapter 104. The vial engagement end 110 includes a collar 150 that is coupled to the central body 152 of the liquid-delivery adapter 104 along with the support structure 154. The height of the collar can vary. For example, in one embodiment, the collar 150 has a height 150a as shown in FIG. In another embodiment, the collar 150 has a height 150b as shown in FIG. In one embodiment, the height of collar 150 is about 0.05 inches, about 0.10 inches, about 0.15 inches, about 0.2 inches, about 0.25 inches, about 0.3 inches, about 0.35 inches, about 0.4 inches, about 0.45 inches, , About 0.55 inches, about 0.6 inches, about 0.65 inches, about 0.70 inches, about 0.75 inches, about 0.80 inches, about 0.85 inches, about 0.90 inches, about 0.95 inches, about 1.00 inches, (E.g., from about 0.10 inch to about 1 inch or about 0.45 inch to about 0.60 inch). In one embodiment, the height of collar 150 is about 1%, about 5%, about 10%, about 15%, about 20%, about 25% o, about 30% , About 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95% , About 110%, about 115%, about 120%, about 125%, about 130%, about 135%, about 140%, about 145%, about 150%, about 155%, about 160% , About 170%, about 175%, about 180%, about 185%, about 190%, about 195%, about 200%, about 205%, about 210%, about 215%, about 220% About 260%, about 265%, about 270%, about 275%, about 280%, about 285%, about 230%, about 235%, about 240%, about 245%, about 250% (E.g., from about 1% to about 100% or about 55%, to about 55%) that can be determined from the aforementioned percentages of the height of the support structure 154, about 290%, about 295%, about 300% 115%). In one embodiment, the collar 150 is configured to function as a guide for the liquid-delivery adapter 104 as the mating end 110 of the vial 102 is associated with the vial 102. In one embodiment, the collar 150 is configured to allow the user to dispense fluid from the vial 102 at a variety of angles relative to the stopper 120 of the vial 102 without disturbing fluid entry into the vial 102, Lt; RTI ID = 0.0 > 104 < / RTI > In one embodiment, the collar 150 aligns the spikes 118 with the puncturable surface of the stopper 120 before the spike contacts the puncturable surface of the stopper 120. The collar 150 is sized sufficiently to insert the spike 118 within the septum of the vial 102 to substantially block the sidewall 145 of the stopper 120 , Thickness). In another embodiment, the collar 150 is angled relative to the stopper 120 of the vial 102 without disturbing the fluid flow from the vial 102 or into the vial 102, 104 and the vial 102. The vials 102, In one embodiment, the collar 150 is generally cylindrical. The collar 150 is not limited to this shape and may have any regular or irregular shape. In one embodiment, the central body 152 includes a wall 171 that separates the vial 102 and the injector mating end 110, 112 from one another, and the spike 118 extends from the central body 152. The collar 150 is retained by the support structure 154 at a distance further from the central body 152 than the length of the spikes 118. In one embodiment, the height of the support structure 154 is about 0.2 inches, about 0.25 inches, about 0.3 inches, about 0.35 inches, about 0.4 inches, about 0.45 inches, about 0.50 inches, about 0.55 inches, about 0.6 inches, (E.g., from about 0.30 inches to about 0.30 inches) that can be determined from the height described above, for example, about 0.75 inches, about 0.70 inches, about 0.75 inches, about 0.80 inches, about 0.85 inches, about 0.90 inches, about 0.95 inches, about 1.00 inches, About 1 inch or about 0.45 inches to about 0.60 inches). Fingers 116 extend inwardly from collar 150 toward spike 118 and are distributed around collar 150. The fingers 116 can be bent to hold the liquid-delivery adapter 104 coupled to the vial 102 and snap-fit against the vial 102. Other embodiments may utilize a variety of mechanisms to couple the liquid-delivery adapter 104 to the vial 102. The fingers 116 may be bent to hold the liquid-delivery adapter 104 coupled to the vial 102 and snap-fit to the vial 102. Other embodiments may use a variety of mechanisms to couple the liquid-delivery adapter 104 to the vial 102.

An engagement slot 160 on the injector mating end 112 with a mating member 174 is also shown in Fig. In general, the mating slot 170 may be configured to engage and releasably receive the flange of the injector or cartridge. The engagement member 174 may be an elastic protrusion in the slot 170 configured to retain the injector or cartridge and the flange in a position generally coupled to the liquid-

9, although the particular dimensions of the liquid-delivery adapter 104 may vary, some exemplary dimensions provide a sense of the scale for a particular embodiment of the liquid- Lt; / RTI > The distance from the outer edge of the collar 150 to the end 112 of the fingers 116 may be, for example, approximately one-half inch. In another embodiment, the distance from the outer edge of the collar 150 to the end of the fingers 116 is about 0.1-0.4 inches. In another embodiment, the distance from the outer edge of the collar 150 to the end 112 of the fingers 116 is about 1/4 inch. The plurality of fingers 116 may be provided with four fingers 116 provided in pairs and configured to have the desired strength for engagement with the vial 102. The length of the injector mating end 112 is typically about 1/2 inch to 1 inch or more, and in one embodiment is about 0.8 inch. Additionally, the diameter of the injector mating end 112 may be up to about one inch or more. In one embodiment, the diameter of the injector mating end 112 is 0.4-0.7 inches, e.g., about 1/2 inch, and in one embodiment about 0.6 inches.

Figure 10 is an enlarged cross-sectional view of the liquid-delivery adapter 104 of Figure 9 taken along line X-X. The tip 122 of the spike 118 may be positioned in the center of the spike 118 in a different direction than the spike 118 in the axial direction (e. G., Offset from the center) Lt; / RTI > Generally, an angled surface 124 may have an angle [theta] with respect to the axis of the spike 118 that may be suitable for penetrating the vial stopper 120. [ For example, the angle [theta] may be up to about 45 degrees with respect to the axis of the spike 118, typically between 10 and 20 degrees, or about 15 degrees in some embodiments. The sloped surface 124 is a length A of 0.1-0.17 inches and a length of 0.14 inches along the spike 118 in one embodiment. The length B along the shaft of the spikes of the curved portion from the inclined portion of the base 162 may be 0.21-0.29 inches and 0.24 inches in one embodiment. The curved portion of the base J may be 0.01-0.03 inches and 0.02 inches in one embodiment. The length C along the shaft of the spike 118 including the curved base 162 may be 0.22-0.29 inches and may be 0.25 inches in one embodiment. As such, the ratio A / B and A / C can be approximately 1/3 to 3/4. In some embodiments, C may be equal to B + J.

Spike 118 may generally have a length of up to about 1/2 inch or more, and may be about 0.4 inch in another embodiment. The ratio of A / D can typically have a width (E) of about 0.05 to 0.2 inches, and is 0.07 to 0.1 inches in one embodiment and about 0.08 inches in another embodiment. The width E of the shaft may be somewhat larger at the base 162 of the shaft 178. The channel 130 may be about 0.02-0.06 inches and may have a diameter F of about 0.04 or 0.05 inches in one embodiment or extend through the center of the spike 118 and taper in a downward proximal direction. The downward taper may start at a location where overlap occurs between the channel 130 and the channel opening 126. The channel 130 may have a length of 0.1-0.2 inches from the base of the shaft 178 relative to the location where the overlap occurs. The overlap of the channel and channel opening 126 may have a length (T) of 0.08-0.1 inches. The channel 130 may have a depth (H) of 0.02 to 0.03 inches, and may be approximately 0.025 inches in one embodiment. The ratio (H / E) can be about 1/4 to 1/3. The longitudinal distance I from the tip 122 to the channel opening 126 may be between 0.06 inches and 0.08 inches, and may be 0.07 inches in one embodiment. The ratio (A / I) can be approximately 2 to 3/4. In some embodiments, D may be A + C or A + B + J.

FIG. 11 shows a beak or three spike tips 122 focused at point 122. The surface 124 meets at the edge 190 and the channel opening 126 is located within the surface of the surface without blocking the edge. The channel opening 126 may generally have a width K of between 0.01 and 0.02 inches and is approximately 0.015 inches in one embodiment while the arc surface 124 has an arcuate length L between approximately 0.06 and 0.1 inches ) And in one embodiment is about 0.08 inches. The ratio of K / L may be 1/10 to 1/3.

In one embodiment, the channel opening 126 is positioned centrally within the sphere 124 so as not to extend generally to the junction of the sphere. Thus, the transverse edges of the channel openings 126 are circumferentially spaced from the edges and arranged radially inward relative to the edge 190. This applies at any axis-oriented station. As such, the measured distance R1 from the axis to the channel opening 126 is less than the distance R2 from the axis to the marginal direction edge of the edge 190. In this embodiment, the channel opening 126 is spaced about 120 degrees from the center when viewed in the axial direction, because this opening is approximately equally spaced and centered on the surface 124. The surface 124 can be spaced about the tip 122 of the spike 118 in any suitable manner. In some embodiments, each of the facets 124 is the same size as the other facets, and in other embodiments one or more facets can be formed of different sizes. In one example, the one or more surfaces 124 may have a width less than 1 / 10th of an inch to meet the side wall 128 of the shaft. In one embodiment, the channel opening 126 may be up to about 30 degrees wide in the radial plane around the center, and may be 5 to 30 degrees wide in one embodiment (e.g., in one embodiment about 20 degrees). The distance G between tip 122 and channel opening 126 may be between 0.01-0.02 inches (e.g., 0.015 inches). In one embodiment, the channel opening 126 tapers along the surface 124, but can alternatively have a substantially constant width.

It is to be understood that the dimensions provided herein are merely exemplary and are not intended to be limiting. In addition, in some embodiments, the dimensions may be altered to permit bonding with a vial and / or syringe having various dimensions and / or to permit certain functions.

As shown in FIG. 12, a cap 220 may be provided to cover the syringe mating end 112 of the liquid-delivery adapter 104 prior to use to aid in maintaining the liquid-transfer in a clean state. The cap 220 may be detachable to engage an injector having a liquid-delivery adapter 104.

13 is a cross-sectional view taken along the line XIV in Fig. As shown, a removable insert 230 is disposed within the injector mating end 112 of the liquid-delivery adapter 104. The insert 230 is configured to have a different size where the injector is coupled to and secured to the liquid-delivery adapter 104. In some embodiments, for example, the internal dimensions of the injector mating end 112 of the liquid-delivery adapter 104 may be sized and configured to accommodate pre-selected jet injector types. The insert 230 may be removed for use of the liquid-delivery adapter 104 including a jet injector. With the insert 230 in place, the insert may provide a selected dimension to accommodate the syringe to reconstitute the medicament. Generally, the insert 230 may include a flange 232 that may be inserted into the mating slot 170 of the liquid-delivery adapter 104 to secure the insert against the adapter. These same slots 170 may be used to engage the jet injector as it is mounted (e.g., by draining liquid from the vial).

FIGS. 14-17 illustrate a process for reconstituting a drug using a syringe 240. FIG. In FIG. 14, each vial 102, liquid-delivery adapter 104 and syringe 240 are shown initially spaced from one another. The liquid-delivery adapter 104 may be moved downward to engage the vial 102. In Figure 15, the cap 220 is removed from the liquid-delivery adapter 104 and the cap 242 is removed from the syringe 240. The syringe 240 is coupled to the liquid-delivery adapter 104 by entering the syringe mating end 112 of the adapter. When the syringe 240 and the liquid-delivery adapter 104 are coupled together, the plunger 244 of the syringe 240 may be recessed to introduce liquid into the vial as shown in Fig. When liquid from the syringe enters the vial 102, the syringe 240 will be removed from the liquid-delivery adapter 104. As shown in FIG. 17, once the syringe is removed from the syringe mating end 112 of the liquid-delivery adapter 104, the insert 230 will also be removed from the liquid-delivery adapter 104.

18-20 illustrate a spike 118 that passes through the rubber stopper 120 of the vial 102 when, for example, the liquid-delivery adapter 104 is engaged with the vial. In particular, FIG. 18 shows the spike 118 from the outside of the vial 102. A plurality of small surfaces 124 may be shown having a channel opening 126 extending over the side wall 128 of the shaft 129 of the spike 118. In addition, metal cap 149 can be shown. The tab of the metal cap can be removed so that access to the remaining portion 261 of the position where the tab is connected to the metal cap 149 and the stopper 120 is allowed. The protrusion 151 of the stopper 120 is also shown and is provided as a target for the spike 118. At the junction between the surfaces 124, the edge 190 is provided as a cutting edge as the spike 118 penetrates the stopper 120.

FIG. 19 shows a view from the inside of the vial as the spike 118 is pressed through the stopper 120. In some embodiments, tearing of the stopper 120 may occur upon insertion of the spike 118. In one embodiment, the edge 190 is sharp enough to provide cut through the elastomeric stopper 120 to aid penetration of the spike 118 therein. The pressure from the stopper 120 is concentrated at the edge 190 as the edge 190 extends more radially than the surface of the surface 124. [ More specifically, the stress concentration from cutting, stretching and / or tearing of the stopper 120 is localized in a direction away from the aperture 126 and instead is concentrated at the point 258 where the edge 190 contacts the stopper do. Thus, the channel opening 126 generally does not provide an edge or point for cutting the stopper 120. This can help prevent coring of the stopper 120 and minimize the penetration of the stopper 120 into the channel opening 126. In one embodiment, the material of the stopper 120 will be pulled in a direction away from the channel opening 126 by the edge 190 and the stopper material expanding within the channel opening 126 is minimized at 259.

FIG. 20 shows a spike 118 fully inserted into the vial 102. As shown, the edge 190 is removed from the stopper 120 and the channel opening 126 is exposed. Although not shown in this figure, the stopper 120 is slightly deflected into the vial 102 as the spike 118 is urged through the stopper 120. As such, in one embodiment, the distal end of the channel opening 126 is arranged at the same height as the stopper 120 or arranged in the stopper 120 such that substantially all liquid in the vial is discharged into the syringe as described above .

21 is a perspective view of another embodiment of a liquid-delivery adapter 200 including a spike 202 having four small faces 204. Each of the facets 204 may be formed of a similar or different size, and in one embodiment has a channel opening 206 extending over the side wall 208 of the spike 202 and from within the plane of the surface. The channel opening 206 is in communication with a channel (not shown) within the spike 202 to provide liquid communication between the two ends of the liquid-delivery adapter 200.

The surface 204 meets at the tip 210 and each surface is combined with an adjacent surface to form an edge 212 (referred to as edge 190 in another embodiment). The tip 210 is axially centered with respect to the spike 202. At the junction of the surface 204, the edge 212 may be used for cutting through the stopper or rubber septum of the vial. In addition, edge 212 is a cutting edge. Additionally, channel opening 206 (referred to as channel 126 in other embodiments) is disposed between edges 212 but does not block or interfere with the edge. As such, the edge 212 is arranged radially outwardly more than the inner portion of the arc surface 204 where the channel opening 206 is arranged. The outwardly facing position of the edge 212 localizes the stress concentration of the septum in a direction away from the channel opening 206 as the spike 202 penetrates therethrough.

All documents specifically mentioned in the Detailed Description of the Invention are incorporated herein by reference in their entirety. As used herein, the term "about" should be understood to refer to both the numerical value and the range of the numerical value. It should also be understood that all numerical ranges herein include each whole integer within the range. Accordingly, the specific embodiments described herein should be understood as illustrative and not in a limiting scope.

While illustrative embodiments of the invention have been disclosed herein, it will be understood that many modifications and other embodiments may be devised by those skilled in the art. For example, features of various embodiments may be used in other embodiments. It is, therefore, to be understood that the appended claims are intended to cover such modifications and implementations as fall within the true spirit and scope of the invention. The contents of each and all of the foregoing references are incorporated herein by reference in their entirety.

Claims (26)

As a liquid-delivery adapter 104 that may be operatively interposed between the injector 106 and the vial 102,
An injector engagement portion 112 configured to be fluidly coupled to the injector 106, and
A vial engagement end 110 including a tip portion 122 configured to puncture a vial septum 700 and a spike 118 having a spike axis, the tip portion 122 having a plurality of arc- Wherein the at least one edge is inclined with respect to the spike axis and the spike includes a channel opening formed in the at least one surface and arranged without blocking the edge, , Said liquid-delivery adapter forming a channel extending in fluid communication with said liquid-
And a collar (150) configured to act as a guide for coupling the liquid-delivery adapter (104) to the vial with the spike (118) inserted into the vial (102)
Characterized in that the collar comprises a curved finger (116) extending towards and surrounding the spike (118) for holding and snap-fastening a liquid-transfer adapter (104) coupled to the vial - Forwarding adapter.
The method of claim 1, wherein the edge comprises a bond between the faces,
Wherein the edge comprises a cutting surface configured to cut the septum as the spike (118) is forced through the septum.
delete The liquid-delivery adapter of claim 1, wherein the tip portion (122) comprises three or more surfaces.
5. The liquid-delivering adapter of claim 4, wherein the channel opening (126) comprises channel openings arranged in three or more respective side faces.
The liquid-repellent delivery system of claim 1, further comprising a seal disposed in the injector-engaging portion (112) configured to mate with the injector (230) or injector for retaining liquid in the injector and channel adapter.
delete delete 3. The device of claim 1, wherein the channel opening (126) is circumferentially spaced from the edge,
The transverse edges of the channel openings 126 are arranged radially inward relative to the edges,
The transverse edges of the channel openings 126 are arranged radially inward relative to the edges at any axial location,
The transverse edge of the channel opening 126 is sufficiently away from the edge to minimize insertion of the septum into the channel opening when the spike 118 penetrates through the septum,
The channel openings 126 are arranged substantially centrally in the circumferential direction on the surface,
Wherein the injector engagement portion has a dimension configured to engage a removable insert (230) or a needleless injector.
delete delete delete delete delete 10. The liquid-dispensing adapter of claim 9, wherein the removable insert is releasably coupled within the injector engagement portion to selectively configure the injector engagement position for engaging the injectors of various sizes.
16. The injector of claim 15 wherein the removable insert comprises a dimension suitable for engagement with a syringe having a first width and wherein the injector engaging portion is coupled to a jet injector having a second width greater than the first width, Wherein the liquid-delivery adapter is configured to receive the liquid-delivery adapter.
The device of claim 1, wherein the spike (118) comprises a shaft extending from the tip toward the injector engagement portion (112), the opening extending over the shaft to maximize fluid drainage from the vial with the vial in an inverted position And the liquid-delivery adapter.
2. The method of claim 1 wherein the edge meets at a point substantially in the axial center,
Wherein the surface of the liquid-delivery adapter is a substantially flat slope.
delete delete The collar (150) of claim 1, wherein the collar (150) has a height sufficient to assist in insertion of the liquid-transfer adapter spike (118) within the vial septum target,
The collar 150 has a height sufficient to assist in insertion of the liquid-transfer adapter spike 118 into the vial septum to substantially block the sidewall of the stopper,
The collar 150 has a height sufficient to allow attachment of the vial to the liquid-delivery adapter 104 at an angle to the vial without interfering with the flow from the vial or into the vial. Delivery adapter. delete delete delete delete delete
KR1020147003621A 2011-07-15 2012-07-13 Liquid-transfer adapter beveled spike KR101958042B1 (en)

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US13/184,211 US9220660B2 (en) 2011-07-15 2011-07-15 Liquid-transfer adapter beveled spike
US13/184,211 2011-07-15
US201261671037P 2012-07-12 2012-07-12
US61/671,037 2012-07-12
PCT/US2012/046639 WO2013066435A2 (en) 2011-07-15 2012-07-13 Liquid-transfer adapter beveled spike

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JP2017221717A (en) 2017-12-21
WO2013066435A2 (en) 2013-05-10
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AU2012324002A1 (en) 2013-05-30
ES2672784T3 (en) 2018-06-18
PT3050588T (en) 2018-05-29
LT3050588T (en) 2018-07-10
JP6198732B2 (en) 2017-09-20
AU2012324002B2 (en) 2015-07-16
AU2012324002C1 (en) 2016-03-24
KR20140044910A (en) 2014-04-15
EP2731652A2 (en) 2014-05-21
ES2592180T3 (en) 2016-11-28
JP2014526920A (en) 2014-10-09
EP2731652B1 (en) 2016-08-17
EP2731652B8 (en) 2016-10-19

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