WO2010093581A2 - Adaptateurs de capuchons pour flacon de médicament et procédés associés - Google Patents

Adaptateurs de capuchons pour flacon de médicament et procédés associés Download PDF

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Publication number
WO2010093581A2
WO2010093581A2 PCT/US2010/023488 US2010023488W WO2010093581A2 WO 2010093581 A2 WO2010093581 A2 WO 2010093581A2 US 2010023488 W US2010023488 W US 2010023488W WO 2010093581 A2 WO2010093581 A2 WO 2010093581A2
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WO
WIPO (PCT)
Prior art keywords
vial
cap adapter
lumen
wall portion
cap
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2010/023488
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English (en)
Other versions
WO2010093581A3 (fr
Inventor
Willard K. Kelsey
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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Filing date
Publication date
Priority claimed from US12/368,797 external-priority patent/US8162914B2/en
Priority claimed from US12/368,791 external-priority patent/US8123736B2/en
Application filed by Individual filed Critical Individual
Publication of WO2010093581A2 publication Critical patent/WO2010093581A2/fr
Publication of WO2010093581A3 publication Critical patent/WO2010093581A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61J1/202—Separating means
    • A61J1/2037—Separating means having valve 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
    • 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
    • A61J1/2055—Connecting means having gripping 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
    • 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
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting

Definitions

  • the present invention relates to devices and methods for withdrawing medicament from a vial.
  • a typical medicament vial includes an enlarged mouth portion forming an access port for removing liquid medicament from the vial.
  • the mouth portion includes an opening that is sealed by a stopper made of an elastomeric material, such as butyl rubber.
  • a closure typically formed of metal, is crimped over the enlarged mouth portion and the stopper to positively hold the stopper against the opening.
  • the closure has an aperture to expose a central portion of the stopper.
  • a syringe needle pierces the stopper to position the distal end of the needle within the liquid medicament inside the vial. Drawing back on the syringe plunger draws liquid out of the vial and into the syringe barrel.
  • This disclosure describes various embodiments of a medicament vial cap adapter configured to facilitate the transfer of a liquid medicament from a vial to a syringe.
  • These embodiments have several features, no single one of which is solely responsible for the desirable attributes of these embodiments. Without limiting the scope of the present embodiments as expressed by the claims that follow, their more prominent features now will be discussed briefly. This summary, and the following detailed description, will provide an understanding of the present embodiments and the advantages they exhibit, including, without limitation, increased protection for the user, better visibility in a low-light environment, and a reduction or elimination of medicament residue on an outer surface of a sealing stopper in the medicament vial.
  • One embodiment of the present cap adapter comprises a transverse wall portion with a first lumen passing through it.
  • a vial-engaging portion of the cap adapter includes a plurality of clamping members that are circumferentially spaced about an edge of the transverse wall portion and that extend distally from the transverse wall portion. The clamping members are configured to snap fit about a mouth portion of the vial to secure the cap adapter to the vial.
  • a spike extends distally from the transverse wall portion and defines a second lumen passing through the transverse wall portion. The second lumen is spaced from and not in fluid communication with the first lumen.
  • the spike includes a sharp distal tip that is configured to pierce a sealing stopper on the vial.
  • a cone-shaped shield element extends proximally from a vertex defining an inlet port that communicates with the first lumen, the shield element flaring radially outwardly from the inlet port.
  • the shield element is configured to guide a hypodermic needle toward the first lumen, thereby reducing the risk of needlestick to a user handling the vial.
  • a transverse wall portion with a first lumen passing through it comprises a transverse wall portion with a first lumen passing through it.
  • a vial-engaging portion of the cap adapter includes a plurality of clamping members that are circumferentially spaced about an edge of the transverse wall portion and that extend distally from the transverse wall portion.
  • the clamping members are configured to snap fit about a mouth portion of the vial to secure the cap adapter to the vial.
  • a light source cooperates with the cap adapter and is configured to illuminate at least a portion of the cap adapter to enhance the visibility of the vial in a low-light environment.
  • a transverse wall portion with a first lumen passing through it comprises a transverse wall portion with a first lumen passing through it.
  • a vial-engaging portion of the cap adapter includes a plurality of clamping members that are circumferentially spaced about an edge of the transverse wall portion and that extend distally from the transverse wall portion.
  • the clamping members are configured to snap fit about a mouth portion of the vial to secure the cap adapter to the vial.
  • a secondary sealing member abuts a distal face of the transverse wall portion and seals a distal end of the first lumen.
  • Figure 1 is a perspective view of one embodiment of a cap adapter for a medicament vial in accordance with the present disclosure
  • Figures 2A and 2B are cross-sectional views of the cap adapter of Figure 1, taken through the line 2-2 in Figure 1 ;
  • Figure 3 is an exploded front elevation view of the cap adapter of Figure 1;
  • Figure 4 is a cross-sectional view of the cap adapter of Figures 1-3 in combination with a medicament vial and a syringe;
  • Figure 5 is a detail view of the portion of Figure 4 indicated by the circle 5-5;
  • Figure 6 is an exploded cross-sectional view of the cap adapter of Figures 1-3 in combination with a medicament vial;
  • Figure 7 is a cross-sectional view of the assembled cap adapter and medicament vial of Figure 6;
  • Figure 8 is a perspective view of another embodiment of a cap adapter for a medicament vial in accordance with the present disclosure.
  • Figure 9 is a right side elevation view of the cap adapter of Figure 8.
  • Figure 10 is a cross-sectional view of the cap adapter of Figure 9, taken through the line 10-10 in Figure 9;
  • Figure 11 is an exploded perspective view of the cap adapter of Figure 8.
  • Figure 12 is a detail view of the portion of Figure 11 indicated by the circle 12-12;
  • Figure 13 is a sectioned perspective view of the cap adapter of Figure 8, taken through the line 13-13 in Figure 8;
  • Figure 14 is a bottom perspective view of the shield portion of the cap adapter of Figure 8.
  • Figure 15 is a detail view of the portion of Figure 14 indicated by the circle 15-15;
  • Figure 16 is a rear elevation view of the cap adapter of Figure 8.
  • Figure 17 is a cross-sectional view of the cap adapter of Figure 16, taken through the line 17-17 in Figure 16;
  • Figure 18 is a detail view of the portion of Figure 17 indicated by the circle 18-18;
  • Figure 19 is a detail view of the portion of Figure 17 indicated by the circle 19-19;
  • Figure 20 is a front elevation view of another embodiment of a cap adapter for a medicament vial in accordance with the present disclosure.
  • Figure 21 is a cross-sectional view of the cap adapter of Figure 20, taken through the line 21-21 in Figure 20;
  • Figure 22 is a perspective view of another embodiment of a cap adapter for a medicament vial in accordance with the present disclosure.
  • Figure 23 is a front elevation view of the cap adapter of Figure 23;
  • Figure 24 is a cross-sectional view of the cap adapter of Figure 23, taken through the line 24-24 in Figure 23;
  • Figure 25 is an exploded bottom perspective view of another embodiment of a cap adapter, which includes a locking sleeve, in accordance with the present disclosure
  • Figure 26 is an exploded top perspective view of the cap adapter of Figure 25;
  • Figure 27 is an assembled bottom perspective view of the cap adapter of Figure 25, showing the cap adapter and the locking sleeve in a first relative rotated position;
  • Figure 28 is an assembled bottom perspective view of the cap adapter of Figure 25, showing the cap adapter and the locking sleeve in a second relative rotated position;
  • Figure 29 is a cross-sectional view of the assembled cap adapter of Figure 27 engaging a medicament vial
  • Figure 30 is a cross-sectional view of the assembled cap adapter of Figure 28 engaging a medicament vial
  • Figure 31 is an assembled bottom perspective view of another embodiment of a cap adapter with a locking sleeve for a medicament vial in accordance with the present disclosure, showing the cap adapter and the locking sleeve in a first relative rotated position;
  • Figure 32 is an assembled bottom perspective view of the cap adapter of Figure 31, showing the cap adapter and the locking sleeve in a second relative rotated position.
  • Figures 1-3 illustrate one embodiment of the present cap adapter 40 for a medicament vial.
  • Figures 2A and 2B are identical to provide sufficient space to show clearly, and without clutter, the numerous reference numbers and lead lines needed to describe the structure illustrated therein.
  • the cap adapter 40 is configured to facilitate the transfer of liquid medicament from the vial into a syringe, as described in further detail below.
  • the cap adapter 40 comprises a transverse internal wall portion 42.
  • An integral conduit portion 43 extends proximally from the transverse internal wall portion 42 and defines a first lumen 44 that passes through the transverse wall portion 42.
  • the first lumen 44 is located and configured to permit passage of a hypodermic syringe needle during a transfer of liquid medicament from the vial and into the syringe, as explained below.
  • a circumferential axial wall portion 45 extends proximally from a peripheral edge of the transverse wall portion 42.
  • a vial-engaging portion 46 of the cap adapter 40 comprises a plurality of clamping members 48 that extend distally and substantially axially from an outer peripheral edge of the transverse wall portion 42.
  • the clamping members 48 are circumferentially separated from each other by a plurality of substantially axial slots 50.
  • Each clamping member 48 is cantilevered radially from the wall portion 42.
  • each clamping member 48 includes a substantially straight portion 54 extending distally from the wall portion 42, an internally ridged portion 56 and a radially outwardly flaring skirt portion 58.
  • the clamping members 48 are configured to snap fit about a mouth portion of a standard medicament vial to secure the cap adapter 40 to the vial, as described below.
  • a shield element 60 extends proximally from the transverse wall portion 42.
  • the shield element 60 includes a substantially conical entrance portion 61 ( Figures 2 A and 2B) extending proximally from an annular base 68 that is circumferentially surrounded by the axial wall portion 45, and that has a distal surface that seats against the proximal surface of the transverse wall portion 42.
  • the conical configuration of the entrance portion 61 of the shield element 60 serves to guide a syringe needle toward the first lumen 44, thereby to reduce a risk of needlestick to a user handling the vial, as described in further detail below.
  • the shield element 60 is fabricated as a separate piece from the wall portion 42, but it may be integral therewith or adhesively fixed thereto. If, as shown, the shield element 60 and the transverse wall portion 42 are separate components, the shield element 60 may advantageously be held in place against the transverse wall portion 42 by a circumferential lip or detent 66 that extends radially inwardly over the peripheral edge of the base 68.
  • a hollow spike 70 extends distally from the distal surface of the transverse wall portion 42.
  • the interior of the spike 70 defines a second lumen 72, the proximal portion of which passes through the transverse wall portion 42.
  • the second lumen 72 is spaced from, and fluidly isolated from, the first lumen 44.
  • the spike 70 includes a sharp tip 74 at its distal end that is configured to pierce a sealing stopper 138 ( Figure 4) in the mouth portion of the vial, as described below.
  • a radial outlet port 75 that communicates with the second lumen 72.
  • the spike 70 establishes fluid communication between the ambient atmosphere and the interior of the vial. Ambient air can thus pass into the vial to equalize the fluid pressure on either side of the sealing stopper 138 as medicament is withdrawn from the vial.
  • the cap adapter 40 further includes a vent passage 76 in fluid communication with the second lumen 72 by means of an axial connecting passage 95 that extends through the base 68 of the shield element 60 between a distal end 82 of the vent passage 76 and a proximal end of the second lumen 72.
  • the vent passage 76 is open to the ambient atmosphere at a proximal end 78 spaced from the second lumen 72.
  • the vent passage 76 includes a one-way valve or check valve 80 configured to allow air to flow into the vial through the vent passage 76 and the second lumen 72.
  • the one-way valve 80 is further configured to inhibit the liquid medicament in the vial from escaping through the second lumen 72 and the vent passage 76.
  • the vent passage 76 extends along an outside of the conical entrance portion 61 of the shield 60.
  • the vent passage 76 could be located elsewhere.
  • the overflow riser 84 is substantially cylindrical and includes a space 86 at a distal end 87 ( Figure 3) for receiving a ball 88 ( Figures 2B and 3) having a diameter that is slightly smaller than an interior diameter of the space 86 so that air can flow past the ball, as discussed below.
  • An intermediate portion of the overflow riser 84 includes a step 90 (Figure 2B) at which the interior diameter of the overflow riser 84 decreases.
  • the diameter of the step 90 is smaller than that of the ball 88 so that the ball 88 creates a seal inside the overflow riser 84 when it rests against the step 90, as when the cap adapter 40 is inverted from the orientation shown in Figure 2B. In the inverted orientation, engagement of the ball 88 against the step 90 substantially prevents liquid medicament from escaping to ambient through the vent passage 76.
  • the ball 88 and the overflow riser 84 together comprise a ball valve 91 ( Figure 2B) that allows flow in only one direction, from the ambient atmosphere into the vial. The operation of the ball valve 91 is discussed in greater detail below.
  • the overflow riser 84 has a proximal end 92 that receives a duckbill valve 94.
  • the duckbill valve 94 the structure of which is well-known to those of skill in the art, is oriented so that it allows fluid flow in only one direction (i.e., distally), through the vent passage 76, from the ambient atmosphere into the vial.
  • the duckbill valve 94 inhibits the passage of the liquid medicament from the vial to the ambient environment through the vent passage 76.
  • the ball valve 91 and the duckbill valve 94 provide redundant seals that greatly reduce the likelihood that any medicament will leak out of the vial and the cap adapter through the vent passage 76.
  • the interior space 86 of the overflow riser 84 provides a chamber for receiving and capturing any proximal backflow of medicament through the second lumen 72 and the internal axial passage 95.
  • the slightly smaller diameter of the ball 88 as compared to the ball receiving space 86 enables any medicament that enters the overflow riser 84 to travel back down into the vial when the vial is held right-side up (i.e., the orientation shown in Figs. 2A and 2B).
  • the vent passage 76 advantageously enables air to flow from the ambient atmosphere into the vial to equalize the pressure on either side of the sealing stopper 138 and to facilitate withdrawal of medicament from the vial, as discussed in further detail below. From the ambient atmosphere, air flows into the vent passage 76, through the duckbill valve 94 and into the overflow riser 84. Properties of the duckbill valve 94 can be tailored to produce a desired cracking pressure at which the duckbill valve 94 opens to allow airflow therethrough. The air then flows through the overflow riser 84 and past the ball 88.
  • the vent passage 76 may include in its interior an optional tubular filter seat 96 upstream from (i.e., proximally from) the duckbill valve 94.
  • the filter seat 96 advantageously has a distal portion 100, having a first outside diameter, that is received in the proximal end of the overflow riser 84, and to which the upstream (proximal) end of the duckbill valve 94 is fixed for fluid communication therewith.
  • the filter seat 96 has a proximal portion 98, with a second outside diameter larger than the first outside diameter of the distal portion 100, that receives an optional filter 102.
  • the filter 102 removes contaminants and pathogens from ambient air passing through the vent passage 76.
  • the filter 102 may optionally be treated with an anti-microbial substance, of a type well-known in the art.
  • the filter 102 seats against a shoulder 104 ( Figure 2B) formed at the junction of the distal portion 100 and the proximal portion 98 to prevent the filter 102 from being sucked down toward the overflow riser 84 by inrushing air.
  • the filter 102 may be replaceable, either separately from, or together with, the filter seat 96.
  • a secondary sealing member 106 may optionally be provided on the distal surface 108 of the transverse wall portion 42 so as to seal a distal end 110 of the first lumen 44.
  • the secondary sealing member 106 is formed of an elastomeric material, and it is located and configured to seat against the exterior surface of the sealing stopper 138 on the vial when the cap adapter 40 is secured about the mouth portion of the vial, as discussed in further detail below.
  • the secondary sealing member 106 is shaped substantially as a stepped disk, including a thickened central portion 112 circumferentially surrounded by a thinner portion 114. The central portion 112 seals the distal end 110 of the first lumen 44. It will be appreciated that the secondary sealing member 106 may have other configurations, such as a constant thickness, a smaller diameter, etc.
  • the illustrated cap adapter 40 may further comprise an optional light source 116 configured to illuminate at least a portion of the cap adapter 40.
  • the light source 116 comprises a chemiluminescent ring 116 that extends around the base portion 68 of the shield 60, substantially surrounding the first lumen 44.
  • the circumferential axial wall portion 45 extends proximally from the edge 52 of the wall portion 42 and surrounds the light source 116.
  • the axial wall portion 45 connects to the transverse wall portion 42 at a plurality of discrete locations 118, creating a plurality of first gaps 120 that separate the axial wall portion 45 from the transverse wall portion 42.
  • a plurality of second gaps 122 extend perpendicularly to the plurality of first gaps 120 and separate sections 124 of the axial wall portion 45 from one another.
  • the gaps 120, 122 allow the sections 124 to readily flex inwardly under a radial squeezing force provided around the periphery of the axial wall portion 45.
  • a user can, for example, provide a squeezing force by wrapping his or her thumb and forefinger around the axial wall portion 45.
  • the squeezing force causes the sections 124 to bear against the light source 116.
  • a threshold squeezing force induces a chemical reaction within the chemiluminescent ring 116 that produces light.
  • the cap adapter 40 is constructed of one or more translucent materials.
  • the cap adapter 40 may be constructed of polycarbonate, acrylic, polypropylene, styrene, or any other suitable plastic material.
  • the light source 116 When the light source 116 is illuminated, light is transmitted through the cap adapter to provide an advantageous visual cue to a user at night or in a low ambient light environment.
  • the user may reliably guide a syringe needle into the first lumen 44 when there is little or no ambient light, further reducing the risk of needlestick to the user.
  • portions of the cap adapter 40 may be constructed from opaque materials, or treated to reduce or eliminate the ability to transmit light. For example, on a darkened battlefield it may be advantageous to reduce the visibility of the cap adapter 40 to others besides the user.
  • substantially all portions of the cap adapter 40 other than the interior 126 ( Figures 1, 2 A and 2B) of the shield 60 may be constructed of or treated with an opaque or semi-opaque material. To the user looking into the interior 126 of the shield 60 from the proximal side, the shield 60 will appear to glow and thus guide the user to the first lumen 44.
  • Figure 4 illustrates the cap adapter 40 of Figures 1-3 engaging a medicament vial 128 and a syringe 130.
  • Figure 5 illustrates a detail view of the portion of Figure 4 indicated by the circle 5-5.
  • the clamping members 48 extend around the mouth portion 132 of the vial 128.
  • the straight portion 54 of each clamping member 48 extends along a flat side of an enlarged portion 134 of the mouth portion 132.
  • the straight portions 54 may- abut the enlarged mouth portion 134 to reduce relative lateral movement of the vial 128 and the cap adapter 40.
  • the internally-ridged portion 56 extends around an underside 136 of the enlarged mouth portion 134 to resist relative axial movement of the cap adapter 40 away from the vial 128.
  • the cap adapter 40 may be removed from the vial 128 by applying sufficient oppositely directed axial forces to the vial 128 and the cap adapter 40.
  • the spike 70 penetrates the sealing stopper 138 and establishes fluid communication between the interior 140 of the vial 128 and the vent passage 76 via the second lumen 72 and the axial passage 95.
  • the spike 70 thus enables ambient air to enter the vial 128 as medicament is withdrawn.
  • the entering air equalizes fluid pressures on opposite sides of the sealing stopper 138, making it easier for the user to withdraw liquid from the vial 128 since he or she does not have to overcome a vacuum force tending to pull the syringe plunger 142 ( Figure 4) back into the syringe barrel 144.
  • the filter 102 advantageously reduces the likelihood of contaminants entering the vial with the incoming ambient air 128.
  • the valves 91, 94 reduce the likelihood that the medicament within the vial 128 will escape to the ambient.
  • the secondary sealing member 106 abuts against the exterior surface 146 of the vial sealing stopper 138.
  • a syringe needle 148 extends through the first lumen 44, penetrates the secondary sealing member 106 and the sealing stopper 138, and extends into the vial interior 140.
  • the user may withdraw medicament from the vial 128 by positioning the distal tip 150 of the needle 148 within the liquid and drawing back on the plunger 142. The user may then withdraw the needle 148 from vial 128 to perform an injection.
  • Figures 4-7 illustrate one embodiment of a method of using the present cap adapter 40 to withdraw medicament from a vial 128.
  • the user positions the vial-engaging portion 46 adjacent the mouth portion 132 of the vial 128 with the skirt portion 58 facing the enlarged portion 134.
  • the user then applies digital pressure to force the vial 128 and the cap adapter 40 together.
  • the sharp tip 74 of the spike 70 penetrates the sealing stopper 138.
  • the clamping members 48 expand radially as the ridge portion 56 passes over the enlarged portion 134.
  • the vial-engaging portion 46 snaps onto the vial 128 as shown in Figure 7 to create a vial/cap assembly 152.
  • the secondary sealing member 106 abuts against the exterior (proximal) surface of the sealing stopper 138, and the spike 70 establishes fluid communication between the interior 140 of the vial 128 and the vent passage 76, as described above.
  • the user guides the needle 148 into the first lumen 44.
  • the entrance portion 61 of the shield 60 advantageously guides the distal tip 150 of the needle 148 toward the first lumen 44 while at the same time forming a barrier between the sharp needle tip 150 and the user's hand and fingers. The user is thus well protected from accidental needlestick.
  • the shield element 60 may be constructed of any suitable material that substantially prevents the needle from piercing the shield 60 under conditions of anticipated use. The user is thus unlikely to be stuck by a needle passing completely through the shield 60 and into the user's hand.
  • the user pierces the secondary sealing member 106 and the sealing stopper 138 to insert the needle tip 150 into the vial 128 as shown in Figures 4 and 5.
  • the user then withdraws a desired amount of medicament from the vial 128 by positioning the distal tip 150 of the needle 148 within the liquid and drawing back on the plunger 142.
  • the user then withdraws the needle 148 from the vial 128 through the sealing stopper 138 and the secondary sealing member 106.
  • the abutment of the secondary sealing member 106 and the sealing stopper 138 creates a fluid seal that prevents the liquid medicament from being deposited on the outer surface 146 of the sealing stopper 138 through the tip 150 of the needle 148 as it passes the sealing stopper 138.
  • the abutment thus reduces the likelihood that medicament residue will be left on the exterior surface 146 of the sealing stopper 138, which could result in contamination of the environment by such residue.
  • the shield element 60 could have a shape different from the illustrated embodiments in which it is substantially cone-shaped.
  • the shield 60 could include an outwardly flared portion in the region near the wall portion 42 and a substantially cylindrical portion adjoining the flared portion at a location spaced proximally from the wall portion 42.
  • substantially any shape that guides the needle toward the first lumen 44 and/or protects the user from needlestick would be suitable.
  • FIGs 8-19 illustrate another embodiment of the present cap adapter 160 for a medicament vial.
  • the cap adapter 160 is similar in many respects to the cap adapter 40 described above and illustrated in Figures 1-7.
  • the cap adapter 160 includes a light source 162 comprising a light-emitting diode (LED) 162 ( Figures 10-13).
  • a power source 164 such as a battery 164, provides power to light the LED 162.
  • the LED 162 and the battery 164 reside between the base 166 of the shield 168 and the wall portion 42.
  • the shield base 166 includes cavities 170, 172 to accommodate the LED 162 and the battery 164, respectively.
  • the LED 162 includes first electrical leads 174 extending in opposite directions from the LED 162, and the battery 164 includes second electrical leads 176 extending in opposite directions from the battery 164.
  • the first and second electrical leads 174, 176 extend toward each other inside the curved interior of the axial wall portion 178.
  • the first and second electrical leads 174, 176 overlap ( Figure 12), but do not contact each other ( Figures 16-19). Thus, in an initial configuration no power flows from the battery 164 to the LED 162.
  • the axial wall portion 178 includes first and second opposed tabs 180, which flare outwardly from the axial wall portion 178 at a position proximally spaced from the wall portion 42.
  • the tabs 180 provide a contoured surface for the user's thumb and forefinger.
  • gaps 182 space the tabs 180 from the wall portion 42 in the areas beneath the tabs 180. The gaps 182 facilitate the flexing of the axial wall portion 178 inwardly when the user squeezes the tabs 180.
  • each of the tabs 180 includes a conductive layer 184 on its inward surface.
  • the cap adapter 160 can thus advantageously be illuminated and darkened repeatedly. Not only does this feature prolong the lifespan of the cap adapter 160, but it also enhances the utility of the cap adapter 160 in environments where it is advantageous for the cap adapter 160 to be illuminated only intermittently for short periods of time, such as on a darkened battlefield.
  • the cap adapter 160 may be initially shipped with a removable pull tab 186.
  • the pull tab 186 is made of a ribbon or tape of insulative material, and it provides an insulator between the conductive layer 184 on one of the tabs 180 and the adjacent first and second electrical leads 174, 176, as shown in Figure 18.
  • the tab 186 thus prevents inadvertent contact between the leads 174, 176 and the conductive layer 184. Inadvertent squeezing forces applied to the tabs 180 thus do not cause the LED 162 to illuminate, which preserves the lifespan of the battery 164.
  • the user removes the pull tab 186 by grasping the protruding portion and pulling.
  • removable pull tabs 186 may be provided for both tabs 180 of the cap adapter 160.
  • Figures 20 and 21 illustrate another embodiment of the present cap adapter 200 for a medicament vial.
  • the cap adapter 200 is similar to the cap adapter 40 described above and illustrated in Figures 1-7.
  • the cap adapter 200 does not include a spike comprising a second lumen.
  • the cap adapter 200 further does not include a vent passage, filter, secondary sealing member, or axial connecting passage.
  • the cap adapter 200 of Figures 20 and 21 is thus advantageously less expensive to manufacture than the cap adapters 40, 160 described above, because it is less complex.
  • the cap adapter 200 of Figures 20 and 21 advantageously includes a needle entrance lumen 202 that is larger than the first lumen 44 of the cap adapter 40 of Figures 1-7.
  • the user secures the cap adapter 200 over the medicament vial substantially as described above with respect to the embodiment of Figures 1-7.
  • the user then inserts a syringe needle through the secondary seal 106 ( Figure 21) and the vial sealing stopper and into the interior of the vial.
  • the larger lumen 202 advantageously provides a larger target for the user as he or she guides the syringe needle.
  • the user may withdraw liquid from the vial by drawing back on the syringe plunger after the needle has been inserted into the vial.
  • the user may pressurize the vial by drawing the plunger back prior to penetrating the secondary seal and the vial sealing stopper, and then injecting air into the vial.
  • FIGs 22-24 illustrate another embodiment of the present cap adapter 210 for a medicament vial.
  • the cap adapter 210 is needleless, meaning that it is adapted to operate with a syringe having no hypodermic needle.
  • the cap adapter 210 includes a transverse wall portion 212 having a central orifice 214 and a vial-engaging portion 216 extending distally from the wall portion 212.
  • the cap adapter 210 further includes a light source 218, which in the illustrated embodiment is a chemiluminescent ring 218 similar to that described above.
  • a hollow spike 220 extends distally from the transverse wall portion 212, terminating in a sharp distal tip 215.
  • the interior of the spike 220 defines a lumen 217 that is aligned with and in fluid communication with the central orifice 214.
  • the lumen 215 terminates in an inlet port 219 proximal to the distal tip 215.
  • a female luer fitting 222 extends proximally from the wall portion 212.
  • the interior of the female luer fitting 222 includes an internal annular shoulder 226 between a distal portion 228 having a first inside diameter and a proximal portion 230 having a second inside diameter that is less than the first inside diameter.
  • the interior of the female luer fitting 222 receives a resilient elastomeric sealing member 232 that conforms to the interior of the female luer fitting 222.
  • the sealing member 232 includes an external annular shoulder 233 that seats against the internal annular shoulder 226 of the female luer fitting 222 to fix the axial position of the sealing member 232 relative to the female luer fitting 222.
  • the sealing member 232 has a distal surface that seats against the proximal surface of the transverse wall 212, and it has an interior cavity 234 with an open distal end that communicates with the central orifice 214 of the transverse wall 212.
  • the proximal portion of the sealing member 232 includes a slit 235 that opens fluid communication into the interior cavity 234 and through the sealing member 232 when forced open, as described below.
  • the proximal end of the female luer fitting 222 is configured to receive a male luer fitting (not shown) that is fixed to the distal end of a needleless syringe (not shown).
  • the male luer fitting is threaded for engagement with a thread 236 on the female luer fitting 222.
  • the male luer fitting is threaded into the female luer fitting 222, it forces open the slit 235 in the sealing member 232.
  • the syringe engaging the female luer fitting 222 and the sealing member 232 forced open, fluid communication is established between the cavity 234 and the syringe.
  • the syringe can thus withdraw liquid from a vial to which the cap adapter 210 is attached.
  • FIGs 25-30 illustrate another embodiment of the present cap adapter 250 for a medicament vial 128.
  • the cap adapter 250 includes a vial-engaging element 260 that is similar in many respects to the cap adapter 40 described above and illustrated in Figures 1-7.
  • the vial-engaging element 260 includes a transverse wall 252 having a first lumen 254 extending axially through its center.
  • a spike 256, defining a second lumen 258 extends distally from the transverse wall 252, at a position radially offset from the first lumen 254.
  • a circumferential axial wall 264 extends proximally from the transverse wall 252, and a plurality of clamping members 262 extend distally from the periphery of the transverse wall 252.
  • the vial-engaging element 260 may advantageously include a shield element and a one-way valve, as described above with respect to the cap adapter 40 of Figures 1-7. However, for clarity the shield element and the one-way valve have been omitted from Figures 25-30.
  • the vial-engaging element 260 of the cap adaptor 250 of Figures 25-30 advantageously includes no more than three or four widely spaced clamping members 262. It will be appreciated that the present cap adapters 40, 160, 200, 210, 250 may include any number of clamping members, and the illustrated configurations are not limiting.
  • the cap adapter 250 further includes a locking sleeve 266.
  • the locking sleeve 266 is substantially cylindrical, and includes a proximal transverse wall 268 having a central aperture 270 ( Figure 26).
  • a secondary seal 272 which seats against a distal surface of the transverse wall 252, includes an off-center opening 274 that receives the spike 256.
  • the transverse wall 268 of the locking sleeve 266 is fixed to the interior of a circumferential rim 278 by a plurality of radial spokes 279 separated by circumferentially spaced slots 276.
  • the locking sleeve 266 has an outer surface 280 that may advantageously include a plurality of circumferentially-spaced depressions 282 that provide gripping surfaces for the user when relatively rotating the vial-engaging element 260 and the locking sleeve 266, as described in further detail below.
  • a proximal inner edge of the locking sleeve 266 includes a lip or detent 284 that extends radially inwardly so as to engage the periphery of the proximal surface of the transverse wall 252 of the vial-engaging member 250, thereby to prevent the separation of the cap adapter components in the axial direction.
  • Figure 27 illustrates the cap adapter 250 and locking sleeve 266 in an assembled, unlocked configuration.
  • An inner surface 286 of the locking sleeve 266 includes three circumferentially spaced elevated surfaces 288.
  • the elevated surfaces 288 are configured and located so as to engage the clamping members 262, as described in detail below.
  • each of the elevated surfaces 288 includes a ramped surface 290 that extends axially, and a clamping surface 292 that extends circumferentially and faces distally.
  • the clamping members 262 Passing over the locking surfaces 294, the clamping members 262 snap radially outward into retaining cavities 296, as shown in Figure 28. Once the clamping members 262 are located in the retaining cavities 296, end walls 298 of the slots 276 prevent further relative rotation of the vial-engaging element 260 and the locking sleeve 266, and the radial locking surfaces 294 prevent reverse relative rotation.
  • each clamping member 262 passes over the radial locking surfaces 294, a leading edge 300 of each clamping member 262 engages a corresponding clamping surface 292.
  • the clamping surfaces 292 are ramped, so that as the vial-engaging element 260 continues rotating relative to the locking sleeve 266, the vial-engaging element 260 is forced distally relative to the locking sleeve 266. This relative axial movement is illustrated in Figures 29 and 30.
  • Figure 29 illustrates the cap adapter 250 engaging a medicament vial 128.
  • the cap adapter 250 is in the unlocked position of relative rotation, which is illustrated in Figure 27.
  • the spike 256 extends through the sealing stopper 138, and the clamping members 262 secure the cap adapter 250 to the medicament vial 128 as described above with respect to the previous embodiments.
  • the secondary seal 272 may abut the sealing stopper 138, or it may be closely spaced therefrom as shown in Figure 29.
  • the user rotates the locking sleeve 266 with respect to the vial- engaging element 260 in the manner described with respect to Figures 27 and 28.
  • the user can withdraw medicament from the vial 128 in the same manner as described above with respect to the cap adapter 40 of Figures 1-7. Because the locking surfaces 294 ( Figure 28) prevent reverse relative rotation of the vial-engaging element 260 and the locking sleeve 266, and because the elevated surfaces 288 prevent outward radial flexing of the clamping members 262, the cap adapter 250 is permanently secured to the vial 128 and cannot be removed without damaging the cap adapter 250 and/or the vial 128. The cap adapter 250 can thus substantially reduce the likelihood that the contents of the vial 128 will escape into the ambient environment.
  • Figures 31 and 32 illustrate another embodiment of the present cap adapter 310 for a medicament vial.
  • the cap adapter 310 is identical to the cap adapter 250 illustrated in Figures 25-30, except for the structure on the interior surface of the locking sleeve.
  • the cap adaptor 310 includes a locking sleeve 314 that includes, on its interior surface, a plurality of circumferentially-spaced locking structures, each of which comprises an elevated surface 320 adjacent the proximal end of the sleeve 314, and a detent structure, adjacent a distal edge of the elevated surface.
  • the detent structure is radially recessed relative to the elevated surface 320; that is, it has a lower elevation relative to the interior surface of the locking sleeve 314 than does the elevated surface 320.
  • Each detent structure comprises a first, upper step 318 and a second, lower step 322, separated by an axial detent lip 312.
  • Each of the locking structures also includes an axially-extending ramped edge 316 that is contiguous with the elevated surface 320 and the first step 318.
  • each of the clamping members 262 rides up over a corresponding ramped edge 316 and onto an adjacent first step 318.
  • the first steps 318 flex the clamping members 262 radially inward.
  • each of the clamping members 262 passes over a detent lip 312 and onto the adjacent (and lower) second step 322. Passing over the lips 312, the clamping members 262 snap radially outward onto the second steps 322, as shown in Figure 32.
  • the lips 312 resist, but do not prevent, reverse relative rotation.
  • the embodiment 310 of Figures 31 and 32 can thus be removed from the medicament vial 128 by reverse relative rotation of the vial-engaging element 260 and the locking sleeve 314.
  • the lips 312 provide a tactile cue that the cap adapter 310 is fully secured on the medicament vial 128, and also provide light resistance against accidental reverse relative rotation.
  • cap adapters and associated methods are, however, susceptible to modifications and alternate constructions from that discussed above that are fully equivalent. Consequently, these cap adapters and associated methods are not limited to the particular embodiments disclosed. On the contrary, these cap adapters and associated methods cover all modifications and alternate constructions coming within the spirit and scope of the cap adapters and associated methods as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the cap adapters and associated methods.

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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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne des adaptateurs de capuchon pour un flacon de médicament configurés pour faciliter le transfert de médicament liquide du flacon dans une seringue. Dans un mode de réalisation, l'adaptateur de capuchon comprend une partie de paroi avec une première lumière la traversant. Une partie venant en prise avec le flacon fixe l'adaptateur de capuchon sur le flacon. Une projection s'étend à partir de la partie de paroi et définit une seconde lumière traversant la partie de paroi. Une protection en forme de cône s'étend depuis la première lumière. La protection est configurée pour guider une aiguille hypodermique vers la première lumière pour ainsi réduire le risque qu'un utilisateur manipulant le flacon se pique avec une aiguille. Dans certains modes de réalisation, une source de lumière coopère avec l'adaptateur de capuchon pour éclairer au moins une partie de l'adaptateur de capuchon et réduire le risque qu'un utilisateur manipulant le flacon dans un environnement sombre se pique avec une aiguille. Dans certains modes de réalisation, un élément de fermeture secondaire appuie contre une première face de la partie de paroi et ferme une extrémité de la première lumière. Dans certains modes de réalisation, un manchon de fermeture résiste au retrait de l'adaptateur de capuchon du flacon de médicament, ou l'empêche.
PCT/US2010/023488 2009-02-10 2010-02-08 Adaptateurs de capuchons pour flacon de médicament et procédés associés Ceased WO2010093581A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US12/368,797 2009-02-10
US12/368,797 US8162914B2 (en) 2009-02-10 2009-02-10 Cap adapters for medicament vial and associated methods
US12/368,791 2009-02-10
US12/368,791 US8123736B2 (en) 2009-02-10 2009-02-10 Cap adapters for medicament vial and associated methods

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WO2010093581A2 true WO2010093581A2 (fr) 2010-08-19
WO2010093581A3 WO2010093581A3 (fr) 2011-04-14

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US9089475B2 (en) 2013-01-23 2015-07-28 Icu Medical, Inc. Pressure-regulating vial adaptors
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CN104913952A (zh) * 2015-05-15 2015-09-16 国家电网公司 一种用于绝缘油气相色谱分析的玻璃注射器密封取样辅助接头装置
US9351905B2 (en) 2008-08-20 2016-05-31 Icu Medical, Inc. Anti-reflux vial adaptors
US9610217B2 (en) 2012-03-22 2017-04-04 Icu Medical, Inc. Pressure-regulating vial adaptors
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