WO2019084371A1 - Adaptor for vials and syringes - Google Patents
Adaptor for vials and syringesInfo
- Publication number
- WO2019084371A1 WO2019084371A1 PCT/US2018/057664 US2018057664W WO2019084371A1 WO 2019084371 A1 WO2019084371 A1 WO 2019084371A1 US 2018057664 W US2018057664 W US 2018057664W WO 2019084371 A1 WO2019084371 A1 WO 2019084371A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- container
- needle
- adaptor
- opening
- recess
- Prior art date
Links
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
- A61J1/2003—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
- A61J1/2096—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
- A61J1/202—Separating means
- A61J1/2044—Separating means having slits
-
- 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
Definitions
- the present invention pertains to adaptors for transferring fluid into and/or out of a container.
- adaptors used to transfer fluid into and/or out of a container.
- Some adaptors have an exposed needle for penetrating a septum of the container.
- U.S. Publication No. 2009/0216212 to Fangrow Jr. discloses a vial adaptor having a penetrating portion that projects between two deflectable tabs.
- Other adaptors have more shielding around the needle, but obstruct much of the view of the vial positioned in the adaptor.
- Adaptors for transferring fluid into and/or out of a container are disclosed.
- the adaptors are arranged to receive a portion of a container and penetrate the portion of the container with a needle when the portion is received in the adaptor.
- the adaptor can include a stop surface arranged to contact the container.
- the stop surface can control (e.g., limit) the depth the needle can be inserted into the container such that an opening of the needle is even (e.g., in-plane) with an adjacent inner surface of the container and/or at least partially in a wall of the container (e.g., a septum) when the container contacts the stop surface.
- the needle can have an open or a closed needle-tip and/or can have an opening in the sidewall of the needle.
- the needle may be a non-coring needle, such as a needle having a Huber or Tuohy tip.
- the opening of the needle can cross an inner surface of the container.
- the opening of the needle can have a first edge portion positioned on a first side of an inner surface of the container and a second edge portion positioned in-line- with the first side of the inner surface and/or on a second side of the inner surface.
- the opening of the needle can have a portion positioned in a wall of the container (e.g., a septum) and/or in a well defined by an inner surface of the container.
- a septum inner surface may taper to form a well.
- the stop surface can extend in a direction transverse to a longitudinal axis of the needle.
- the stop surface can extend in a direction orthogonal to the longitudinal axis of the needle.
- the adaptor body can define a window arranged to allow visualization of the container when the portion of the container is positioned within the recess.
- the adaptor can include indicia.
- the indicia can correspond to one or more attributes of the adaptor, the container receivable in the recess of the adaptor, and/or of the contents of the container.
- the indicia includes gradations along a length of the window that correspond to the volume of liquid within the container.
- the adaptor can include a locking portion arranged to cooperate with a portion of the container so as to lock the container and adaptor to one another.
- the adaptor can include a protrusion that cooperates with a recess (e.g., groove) of the container to lock the adaptor and container together.
- the adaptor can include a recess arranged to receive a protrusion of the container to lock the adaptor and container together.
- such locking portions are arranged so that, once the adaptor and container are locked together, the container and adaptor are unreleasable from one another without destruction of a portion of the adaptor and/or container.
- the adaptor can include a connector.
- the connector can define a lumen in fluid communication with a lumen of the needle.
- the connector can include a valve.
- the valve may close the lumen of the connector and open when the connector is connected with another connector (e.g., tubing or a syringe).
- any of the adaptors described herein may be provided in an assembly or as part of a system.
- Such assemblies and systems can include the container the adaptor is arranged to receive.
- Such assemblies and systems may also include pharmaceutical agent positioned within the container (e.g., drugs or cellular suspension).
- the containers mentioned herein can be syringes or vials, just to name a few non- limiting examples. Portions of such containers receivable by the adaptor can have a needle- penetrable septum. Additionally, such containers can have a vent positioned at an end of the container opposite the needle-penetrable septum.
- FIG. 1 is a perspective view of an exemplary adaptor.
- FIG. 2 is a cross-sectional view of the adaptor of FIG. 1.
- FIG. 3 is a perspective view of a container, specifically a vial.
- FIG. 4 is an exploded, cross-sectional view of the container of FIG. 3.
- FIG. 5 is a cross-sectional view of the vial of FIG. 3 received within the adaptor of FIG. 1.
- FIG. 6 is a cross-sectional view of the vial of FIG. 3 received within another adaptor embodiment.
- FIG. 7 is a perspective view of an adaptor with a make luer connector.
- FIG. 8 is a perspective view of an adaptor with a female luer connector.
- FIG. 9 is a perspective view of an adaptor with an external needle.
- FIG. 10 is a perspective view of an adaptor with tubing.
- Figures 1 and 2 illustrate an adaptor 100 useful for transferring fluid into and/or out of a container such as a syringe and/or vial.
- the adaptor has an adaptor body 101 having a first end region 102 and a second end region 104.
- the first end region has a sidewall 106 having an inner surface 108 and an outer surface 110.
- the inner surface defines a longitudinal recess 112 arranged to receive the container.
- the longitudinal recess is open at a first end 114 and can be at least partially closed at a second end 116.
- the sidewall defines a window, such as a transparent portion and/or a cutout.
- the window can be arranged to allow a user to view a portion of the container positioned within the recess of the adaptor.
- the window can be arranged to allow a user to view the contents of the container positioned within the recess, including the volume of fluid therein, and/or a label of the container.
- the sidewall can have a first longitudinal edge 118 and a second longitudinal edge 120 that define a cutout 122. Cutout 122 can be absent of a material or can include a transparent material 124.
- the window can align with a label and/or markings on the container positioned within the recess.
- the outer surface of the sidewall can include indicia.
- the indicia can be positioned adjacent to and/or in the window.
- the indicia can correspond to one or more attributes of the adaptor, the container receivable in the recess of the adaptor, and/or of the contents of the container.
- the indicia includes gradations along a length of the window that correspond to the volume of liquid within the container.
- the indicia may indicate the volume of fluid within the container when a boundary of the fluid (e.g., a meniscus or a fluid contacting surface of a plunger) aligns with a portion of the indicia.
- the indicia can include one or more colors, symbols, and/or alphanumeric characters that indicate whether a container is one the adaptor is arranged to receive.
- the indicia of the adaptor can be arranged to match and/or complement indicia of a container the adaptor is arranged to receive.
- the adaptor can include a locking portion operable to lock a container in the recess.
- the inner surface of the sidewall can include a locking portion arranged to cooperate with a locking portion of the container to lock to adaptor and container together.
- the locking portions can includes one or more recesses and/or protrusions.
- the inner surface of the sidewall can define a recess 130 that receives a protrusion 132 of the container.
- the inner surface of the sidewall can include a protrusion 132 that is received into a recess 130 of the container.
- the locking portion(s) can have an arrangement that, once locking the container in the adaptor, is unreleasable without destruction of a portion of the adaptor and/or container.
- the locking portion(s) can be positioned proximate the first end 114 of the longitudinal recess, proximate the second end 116 of the longitudinal recess, and/or intermediate the first end and second end of the longitudinal recess.
- a needle 140 Extending into the longitudinal recess from the second end of the longitudinal recess is a needle 140.
- the needle is arranged to pierce a wall (e.g., a septum) of the container portion positioned within the recess.
- the needle has a longitudinal axis 142 and defines a needle lumen 144.
- the needle is preferably a non-coring needle.
- the needle can have a Huber or Tuohy tip.
- the needle can be a closed-tip needle with a side port providing access to the needle lumen.
- the needle may have a side port located proximal the beveled region of the tip.
- the septum-penetrating tip 146 of the needle is preferably positioned within the longitudinal recess defined by the adaptor.
- the septum-penetrating tip of the needle can be positioned between the first end and second end of the longitudinal recess.
- the septum-penetrating tip can be positioned closer to the second end of the longitudinal recess than the first end.
- the longitudinal recess defined by the adaptor can have a cross-sectional dimension (measured in a direction orthogonal to the longitudinal axis of the recess) of 0.5 inch or less, 10 mm or less, and/or 13mm or less.
- the distance between the needle tip positioned in the recess and the first end of the recess can be at least 20 mm, at least 30 mm, at least 40 mm, at least 50 mm, at least 60 mm, at least 70 mm, and/or at least 80 mm.
- such arrangements can aid in avoiding a fingertip from contacting the needle tip inside the longitudinal recess and, therefore, can help prevent unintentional needle sticks of a patient and/or medical professional.
- the adaptor can be arranged such that an opening to the needle lumen is even with an adjacent inner surface of the container when the container is positioned in the adaptor and the needle extends through a wall of the container.
- an opening to the needle lumen can be even with an adjacent inner surface of a needle penetrable septum of the container.
- Such an arrangement can aid in withdrawal all of the fluid from the container, with the exception of residual fluid adhered to the container wall.
- the second end of the adaptor can have a connector 150, such as a luer connector.
- the connector defines a lumen 152 in fluid communication with the lumen of the needle.
- the connector can be a male luer connector (shown in figures 1 and 2) or female luer connector (shown in figure 7) suitable for connecting to a syringe and/or medical tubing.
- the connector can include a valve.
- the connector may include a valve 154 that closes a portion of lumen 152 in a first configuration and is arranged to open and allow fluid communication in a second configuration (e.g, when the connector 150 is mated with another connector).
- the valve includes a flexible material defining a closed slit 156 that opens when compressed and/or twisted, as occurs when the connector 150 is mated with another connector.
- Adaptors may include a spacer 160 positioned between the needle 140 and the adaptor body 101.
- the spacer 160 can be arranged to aid in locating the needle in a needle opening in the adaptor body and/or in the recess of the adaptor during and/or after manufacturing.
- the spacer 160 can be an o-ring that extends around the needle and centers the needle in the needle opening.
- the spacer may be a seal that resists material from leaking outside of the adaptor through a space between the needle and the adaptor body 101.
- FIGS. 3 and 4 illustrate an exemplary container usable with the adapters disclosed herein.
- the container 200 includes a syringe or vial 201 that can be graduated.
- the container 200 has an open lower end 203 and a closed upper end 205.
- the container 200 is essentially a one-piece body forming a hollow interior 202 from the open lower end 203.
- the container can include one or more locking portions (e.g., 132) arranged to cooperate with a corresponding locking portion of the adaptor so as to lock the container to the adaptor.
- the one-piece body is configured to form a pair of tube adapters 207, 208 opening into the hollow interior 202.
- the openings of the two tube adapters into the interior are separated by a wall 210.
- the wall 210 prevents fluid entering through the adapter 208 from being immediately drawn out the adapter 207, particularly when a negative pressure is applied to the adapter 207 to draw fluid into the container.
- the adapter 207 can be connected to a vent, while the adapter 208 can be connected to a source of fluid to be cryogenically preserved within the container 200.
- the container provides for removal of a stored suspension through the lower end (e.g., bottom portion) of the container.
- the open end 203 of the container 201 is closed by a needle -penetrable septum 215.
- the needle-penetrable septum 215 is retained by a cover 217 that is sealed to the open end 203 of the container in a conventional manner to provide a leak- proof seal.
- a removable cover can be provided.
- the cover can be a foil film, and/or the cover can be affixed to the container around the septum.
- the cover can define a tear portion in the form of a thinner or weakened region that allows the central portion of the cover to be removed.
- a tab can be provided to facilitate removal of a portion of the cover over the septum.
- the container 200 further includes an adapter body 220 that includes a vent tube 221 and an inlet tube 223. The ends of the tubes are mounted over the corresponding fittings 207, 208 in a suitable manner to provide a permanent, leak-proof sealed engagement.
- the vent tube 221 can preferably include a filter element 225 lodged within the tube.
- the filter element can be a micro filter, such as a 3 ⁇ sterile micro-filter.
- the micro-filter can be arranged to be gas permeable but generally impermeable to the liquid sample or cell suspension being stored within the container.
- the filter is capable of retaining the suspension within the container and venting gas out of the container when the container is being filled (either partially or completely) and venting gas into the container when suspension is being withdrawn from the container.
- the inlet tube 223 can include a flared end 226 for engagement with a tube adapter.
- the inlet tube can include a needle penetrable septum.
- the inlet branch can be provided with a standard needle or needle-less port.
- the adaptor can be arranged such that an opening to the needle lumen is even with the adjacent inner surface of the container when the container is inserted into the adaptor and the needle of the adaptor penetrates a wall of the container.
- an opening to the needle lumen can be even with an adjacent inner surface of a needle penetrable septum of the container.
- the opening can be defined at least by a first edge portion positioned on a first side of the inner surface and a second edge portion positioned on a second side of the inner surface and/or even with the inner surface.
- the inner surface can face towards the first edge portion and face away from the second edge portion.
- the needle can have an end opening and/or a plurality of side openings without or without a closed needle tip.
- the second edge portion can be positioned in the wall of the container (e.g., in the septum).
- arranging the adaptor and/or container such that an opening of the needle is even with an adjacent inner surface of the needle penetrable septum can enable the withdrawal of substantially all of the fluid (e.g., excluding residual fluid adhered to the inner surface of the container) from the container.
- the inner surface of the container e.g., an inner surface of the septum
- the inner surface of the container can taper towards the portion penetrated by the needle.
- the adaptor can include a stop surface arranged to contact a portion of the container and limit the distance (e.g., depth) the needle can penetrate a wall of the container.
- the stop surface limits the distance the container can be inserted into the adaptor.
- the adaptor may include an inwardly projecting surface, such as surface 168, arranged to contact the container and prevent further insertion of the container into the longitudinal recess of the adaptor and the needle into the septum.
- the adaptor and/or container can be arranged such that when the container is received within the adaptor and contacting the stop surface, the needle of the adaptor protrudes through a wall of the container and has a needle opening even with an adjacent inner surface of the container.
- Figure 5 illustrates a container received within the recess of an adaptor.
- the inner surface 240 of the septum 215 is aligned with the opening 300 of the needle.
- the opening of the needle can be defined at least by a first edge portion 302 positioned on a first side of (e.g., above) the inner surface 240 and a second edge portion 304 positioned on a second side of (e.g., below) the inner surface 240.
- the needle opening can be an end opening.
- the needle opening can be a side opening that is proximal the needle end, as illustrated in figure 6.
- the needle tip 306 may have an opening to the needle lumen or the needle tip may be closed, such as a crimped needle tip.
- the adaptor can have any of a variety of connectors.
- the adaptor may have a connector 150 being male luer connector 170 and/or a female luer connector 172 as shown in figures 7 and 8. These connectors are arranged to mate with, and the adaptors may be provided with, one or more other connectors 176 and/or tubing 180.
- Adaptors described herein may include a second needle 186 (shown in figure 9) having a lumen in fluid communication with the lumen of the needle extending into the recess of the adaptor.
- the second needle can be arranged for tissue-penetration and/or septum penetration.
- the adaptor may include tubing 190 having a lumen in fluid communication with the lumen of the needle extending into the recess of the adaptor.
- Kits, systems, and assemblies including an adaptor and a container (e.g., vial and/or syringe) wherein an opening of a needle of the adaptor aligns (e.g., is even) with an adjacent inner surface of the container when the adaptor and container are mated are envisioned.
- Kits and systems can be provided in sterile medical packaging (e.g., an adaptor and a container can be sealed in sterile medical packaging and packaged togeter).
- a cryopreservation device can include introduction of a cell suspension into the container through the inlet branch, such as through the needle septum described above. As the cell suspension is injected into the container, the air within is vented through the filter in the vent branch. Once the container is partially or completely filled, the two branches can be heat sealed, using for instance a heated pinch sealer, so that the container is hermetically sealed. Of course it is understood that the needle septum and cover can remain intact as the container is filled. Once filled to the desired level and sealed, the container can be
- the container and contents are first thawed. Once thawed, a cover may be removed to expose the septum on the bottom end of the container.
- the vent branch is severed between the sealed portion and the filter element to open the vent passageway.
- a portion of the container is then positioned within the longitudinal recess of the adaptor so that the needle of the adaptor penetrates a wall of the container sufficient to place a lumen of the needle in communication with contents of the container.
- the cell suspension can then be withdrawn through the needle lumen into a syringe or other device (e.g., medical tubing).
- container means an object that can be used to hold or transport a liquid.
- the term includes, but is not limited to, containers having rigid walls, such as syringes and vials.
- fill and “filling” as used herein include complete fill/filling and partial fill/filling of a container.
- syringe as used herein has the ordinary and customary meaning as understood by those in the medical field.
- the term includes a container having an internal chamber of variable volume, such as a chamber defined at least in-part by a movable piston.
- the piston can be useful to draw fluid into the chamber of the syringe and/or expel fluid from the chamber (e.g., to inject fluids into a patient's body).
- vial as used herein has the meaning, a small container arranged to hold liquid and allow for subsequent withdrawal of the liquid. This includes, but is not limited to, containers having a fixed. The volume of the container can be 10 mL or less or 6 mL or less. The term also includes rigid-wall containers, such as a container with a glass or rigid-plastic wall.
- the vials described herein include vials for cryopreservation. The term includes the vials described and/or illustrated in U.S. Patent No. 7,939,316 published on May 10, 2011; U.S. Patent No. 8,222,027 published on July 17, 2012; PCT Publication No. WO 2013/023075 published on April 4, 2013; U.S. Patent No. 8,936,905 published on January 20, 2015; U.S. Publication No. 2015/0140650 published on May 21, 2015; U.S. Patent No.
- the term includes vials having a tubular body with a needle- penetrable septum so as to allow for aseptic withdrawal of fluid from inside the tubular body.
- Certain vials may include one or more tubes extending from the tubular body, the first and second tubes communicating with the interior of the tubular body.
- the first and second tubes may be heat sealable.
- the first tube can have a Luer fitting.
- the second tube can include a sterile filter, such as an anti-microbial filter.
- the filter can have a nominal micron rating between about 10 and 0.1 microns. In some instances, the filter has a nominal micron rating between 5 and 0.1 microns and/or between about 3 and 0.2 microns.
- the first and second tubes can extend from an end of the vial opposite of a needle -penetrable septum.
- vent means an opening to allow equalization of gas pressure between the inside and outside of the container. Vents may allow the passage of gas through the vent (e.g., through a microfilter) and/or include a flexible membrane (e.g., a bag and/or balloon) that allows for expansion and/or contraction of gas within the container.
- a flexible membrane e.g., a bag and/or balloon
- well means a depression for holding a liquid.
- the term includes, but is not limited to, recessed areas such as valleys, troughs, and bowls, just to name a few non-limiting examples.
- a well may be defined by one or more curved surfaces and/or intersecting surfaces.
- An adaptor for a container comprising:
- an adaptor body defining a recess arranged to receive a portion of the container
- a needle extending into the recess and arranged to penetrate into the portion of the container when the portion is received in the recess;
- a stop surface arranged to contact the container to control the depth the needle can be inserted into the container such that an opening of the needle is even with an inner surface of the container when the container contacts the stop surface.
- the opening of the needle has a first edge portion positioned on a first side of the inner surface and a second edge portion positioned in-line-with the first side of the inner surface or on a second side of the inner surface when the container contacts the stop surface.
- the second edge portion is positioned on the second side of the inner surface when the container contacts the stop surface.
- the opening is a side-opening in the needle.
- the stop surface extends in a direction transverse to a longitudinal axis of the needle.
- the adaptor body defines a window arranged to allow visualization of the container when the portion of the container is positioned within the recess.
- a locking portion arranged to cooperate with a locking portion of the container so as to lock the container and adaptor to one another.
- a connector defining a lumen in fluid communication with a lumen of the needle.
- the connector includes a valve that closes the lumen of the connector and opens when the connector is connected with another connector.
- An assembly comprising the adaptor of any preceding clause with the container received within the recess thereof.
- the portion of the vial received within the adaptor has a needle -penetrable septum and the vial has a vent at an end opposing the needle -penetrable septum.
- a system comprising:
- a container having a first end with a needle penetrable septum
- an adaptor having a recess arranged to receive the first end of the container
- the adaptor having a needle extending into the recess and arranged to penetrate the needle penetrable septum when the first end of the container is received in the recess; and the adaptor having a stop surface arranged to contact the container to control the depth the needle can be inserted into the container;
- the needle has an opening in a sidewall of the needle
- the opening of the needle crosses an inner surface of the container when the container contacts the stop surface.
- the opening of the needle has portion positioned in a well defined by an inner surface of the container when the container contacts the stop surface of the adaptor.
- the needle penetrable septum defines the tapered portion.
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Abstract
Adaptors 100 for penetrating a wall of a container (200, 215), such as a syringe or a vial, are arranged to receive a portion of the container (200, 215) and penetrate a septum 215 of the container with a needle 140 such that an opening 300 of the needle 14 is at the same height as an adjacent inner surface 240 of the container (200, 215). Additionally, arrangements are disclosed wherein the adaptor is arranged to lock the container. The adaptors can include a window for viewing the vial's contents and/or a label of the vial, and/or indicia that corresponds to the volume of fluid in the vial.
Description
ADAPTOR FOR VIALS AND SYRINGES
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of US Provisional Application No. 62/577,209 filed October 26, 2017, which is hereby incorporated by reference.
BACKGROUND
The present invention pertains to adaptors for transferring fluid into and/or out of a container. There are a variety of adaptors used to transfer fluid into and/or out of a container. Some adaptors have an exposed needle for penetrating a septum of the container. For example, U.S. Publication No. 2009/0216212 to Fangrow Jr. discloses a vial adaptor having a penetrating portion that projects between two deflectable tabs. Other adaptors have more shielding around the needle, but obstruct much of the view of the vial positioned in the adaptor. For example, U.S. Patent No. 7,615,041 to Sullivan et al. discloses an adaptor with a hollow needle extending downwardly into an inner cavity, but blocks the view of the vial. Additionally, many existing vial adaptors such as those in Fangrow Jr. and Sullivan are ill- suited for drawing all fluid from the vial. Accordingly, there is a desire for further development in this field.
SUMMARY
Adaptors for transferring fluid into and/or out of a container, such as a syringe or a vial, are disclosed. In certain aspects, the adaptors are arranged to receive a portion of a container and penetrate the portion of the container with a needle when the portion is received in the adaptor. The adaptor can include a stop surface arranged to contact the container. The stop surface can control (e.g., limit) the depth the needle can be inserted into the container such that an opening of the needle is even (e.g., in-plane) with an adjacent inner surface of the container and/or at least partially in a wall of the container (e.g., a septum) when the container contacts the stop surface.
The needle can have an open or a closed needle-tip and/or can have an opening in the sidewall of the needle. For example, the needle may be a non-coring needle, such as a needle having a Huber or Tuohy tip.
When the container contacts the stop surface, the opening of the needle can cross an inner surface of the container. The opening of the needle can have a first edge portion positioned on a first side of an inner surface of the container and a second edge portion positioned in-line- with the first side of the inner surface and/or on a second side of the inner surface. Additionally or alternatively, when the container contacts the stop surface the opening of the needle can have a portion positioned in a wall of the container (e.g., a septum) and/or in a well defined by an inner surface of the container. For example, an inner surface of the container, such as a septum inner surface, may taper to form a well.
The stop surface can extend in a direction transverse to a longitudinal axis of the needle. For example, the stop surface can extend in a direction orthogonal to the longitudinal axis of the needle.
The adaptor body can define a window arranged to allow visualization of the container when the portion of the container is positioned within the recess. Additionally or alternatively, the adaptor can include indicia. The indicia can correspond to one or more attributes of the adaptor, the container receivable in the recess of the adaptor, and/or of the contents of the container. In some arrangements, the indicia includes gradations along a length of the window that correspond to the volume of liquid within the container.
The adaptor can include a locking portion arranged to cooperate with a portion of the container so as to lock the container and adaptor to one another. For example, the adaptor can include a protrusion that cooperates with a recess (e.g., groove) of the container to lock the adaptor and container together. Additionally or alternatively, the adaptor can include a recess
arranged to receive a protrusion of the container to lock the adaptor and container together. Preferably, such locking portions are arranged so that, once the adaptor and container are locked together, the container and adaptor are unreleasable from one another without destruction of a portion of the adaptor and/or container.
The adaptor can include a connector. The connector can define a lumen in fluid communication with a lumen of the needle. The connector can include a valve. For example, the valve may close the lumen of the connector and open when the connector is connected with another connector (e.g., tubing or a syringe).
Any of the adaptors described herein may be provided in an assembly or as part of a system. Such assemblies and systems can include the container the adaptor is arranged to receive. Such assemblies and systems may also include pharmaceutical agent positioned within the container (e.g., drugs or cellular suspension).
The containers mentioned herein can be syringes or vials, just to name a few non- limiting examples. Portions of such containers receivable by the adaptor can have a needle- penetrable septum. Additionally, such containers can have a vent positioned at an end of the container opposite the needle-penetrable septum.
Further forms, objects, features, aspects, benefits, advantages, and embodiments of the present invention will become apparent from a detailed description and drawings provided herewith.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of an exemplary adaptor.
FIG. 2 is a cross-sectional view of the adaptor of FIG. 1.
FIG. 3 is a perspective view of a container, specifically a vial.
FIG. 4 is an exploded, cross-sectional view of the container of FIG. 3.
FIG. 5 is a cross-sectional view of the vial of FIG. 3 received within the adaptor of FIG. 1. FIG. 6 is a cross-sectional view of the vial of FIG. 3 received within another adaptor embodiment.
FIG. 7 is a perspective view of an adaptor with a make luer connector.
FIG. 8 is a perspective view of an adaptor with a female luer connector.
FIG. 9 is a perspective view of an adaptor with an external needle.
FIG. 10 is a perspective view of an adaptor with tubing.
DESCRIPTION OF THE SELECTED EMBODIMENTS
For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. One embodiment of the invention is shown in great detail, although it will be apparent to those skilled in the relevant art that some features that are not relevant to the present invention may not be shown for the sake of clarity.
Figures 1 and 2 illustrate an adaptor 100 useful for transferring fluid into and/or out of a container such as a syringe and/or vial. The adaptor has an adaptor body 101 having a first end region 102 and a second end region 104. The first end region has a sidewall 106 having an inner surface 108 and an outer surface 110. The inner surface defines a longitudinal recess 112 arranged to receive the container. The longitudinal recess is open at a first end 114 and can be at least partially closed at a second end 116.
The sidewall defines a window, such as a transparent portion and/or a cutout. The window can be arranged to allow a user to view a portion of the container positioned within the recess of the adaptor. Specifically, the window can be arranged to allow a user to view the contents of the container positioned within the recess, including the volume of fluid therein, and/or a label of the container. For example, the sidewall can have a first longitudinal edge 118 and a second longitudinal edge 120 that define a cutout 122. Cutout 122 can be absent of a material or can include a transparent material 124. The window can align with a label and/or markings on the container positioned within the recess.
The outer surface of the sidewall can include indicia. The indicia can be positioned adjacent to and/or in the window. The indicia can correspond to one or more attributes of the adaptor, the container receivable in the recess of the adaptor, and/or of the contents of the container. In some arrangements, the indicia includes gradations along a length of the window that correspond to the volume of liquid within the container. For example, the indicia may indicate the volume of fluid within the container when a boundary of the fluid (e.g., a meniscus or a fluid contacting surface of a plunger) aligns with a portion of the indicia.
Additionally or alternatively, the indicia can include one or more colors, symbols, and/or alphanumeric characters that indicate whether a container is one the adaptor is
arranged to receive. For example, the indicia of the adaptor can be arranged to match and/or complement indicia of a container the adaptor is arranged to receive.
The adaptor can include a locking portion operable to lock a container in the recess. For example, the inner surface of the sidewall can include a locking portion arranged to cooperate with a locking portion of the container to lock to adaptor and container together. The locking portions can includes one or more recesses and/or protrusions. For example, the inner surface of the sidewall can define a recess 130 that receives a protrusion 132 of the container. Additionally or alternatively, the inner surface of the sidewall can include a protrusion 132 that is received into a recess 130 of the container. The locking portion(s) can have an arrangement that, once locking the container in the adaptor, is unreleasable without destruction of a portion of the adaptor and/or container. The locking portion(s) can be positioned proximate the first end 114 of the longitudinal recess, proximate the second end 116 of the longitudinal recess, and/or intermediate the first end and second end of the longitudinal recess.
Extending into the longitudinal recess from the second end of the longitudinal recess is a needle 140. The needle is arranged to pierce a wall (e.g., a septum) of the container portion positioned within the recess. The needle has a longitudinal axis 142 and defines a needle lumen 144. The needle is preferably a non-coring needle. For example, the needle can have a Huber or Tuohy tip. The needle can be a closed-tip needle with a side port providing access to the needle lumen. For example, the needle may have a side port located proximal the beveled region of the tip.
The septum-penetrating tip 146 of the needle is preferably positioned within the longitudinal recess defined by the adaptor. For example, the septum-penetrating tip of the needle can be positioned between the first end and second end of the longitudinal recess. The septum-penetrating tip can be positioned closer to the second end of the longitudinal recess than the first end.
The longitudinal recess defined by the adaptor can have a cross-sectional dimension (measured in a direction orthogonal to the longitudinal axis of the recess) of 0.5 inch or less, 10 mm or less, and/or 13mm or less. The distance between the needle tip positioned in the recess and the first end of the recess can be at least 20 mm, at least 30 mm, at least 40 mm, at least 50 mm, at least 60 mm, at least 70 mm, and/or at least 80 mm. Advantageously, such arrangements can aid in avoiding a fingertip from contacting the needle tip inside the
longitudinal recess and, therefore, can help prevent unintentional needle sticks of a patient and/or medical professional.
As will be explained in further detail below, the adaptor can be arranged such that an opening to the needle lumen is even with an adjacent inner surface of the container when the container is positioned in the adaptor and the needle extends through a wall of the container. For example, an opening to the needle lumen can be even with an adjacent inner surface of a needle penetrable septum of the container. Such an arrangement can aid in withdrawal all of the fluid from the container, with the exception of residual fluid adhered to the container wall.
The second end of the adaptor can have a connector 150, such as a luer connector.
The connector defines a lumen 152 in fluid communication with the lumen of the needle. The connector can be a male luer connector (shown in figures 1 and 2) or female luer connector (shown in figure 7) suitable for connecting to a syringe and/or medical tubing.
The connector can include a valve. For example, the connector may include a valve 154 that closes a portion of lumen 152 in a first configuration and is arranged to open and allow fluid communication in a second configuration (e.g, when the connector 150 is mated with another connector). In some instances, the valve includes a flexible material defining a closed slit 156 that opens when compressed and/or twisted, as occurs when the connector 150 is mated with another connector.
Adaptors may include a spacer 160 positioned between the needle 140 and the adaptor body 101. The spacer 160 can be arranged to aid in locating the needle in a needle opening in the adaptor body and/or in the recess of the adaptor during and/or after manufacturing. For example, the spacer 160 can be an o-ring that extends around the needle and centers the needle in the needle opening. Advantageously, the spacer may be a seal that resists material from leaking outside of the adaptor through a space between the needle and the adaptor body 101.
Figures 3 and 4 illustrate an exemplary container usable with the adapters disclosed herein. The container 200 includes a syringe or vial 201 that can be graduated. The container 200 has an open lower end 203 and a closed upper end 205. As seen in FIG. 3, the container 200 is essentially a one-piece body forming a hollow interior 202 from the open lower end 203. The container can include one or more locking portions (e.g., 132) arranged to cooperate with a corresponding locking portion of the adaptor so as to lock the container to the adaptor.
At the closed upper end 205, the one-piece body is configured to form a pair of tube adapters 207, 208 opening into the hollow interior 202. The openings of the two tube adapters into the interior are separated by a wall 210. The wall 210 prevents fluid entering through the adapter 208 from being immediately drawn out the adapter 207, particularly when a negative pressure is applied to the adapter 207 to draw fluid into the container. The adapter 207 can be connected to a vent, while the adapter 208 can be connected to a source of fluid to be cryogenically preserved within the container 200.
The container provides for removal of a stored suspension through the lower end (e.g., bottom portion) of the container. The open end 203 of the container 201 is closed by a needle -penetrable septum 215. The needle-penetrable septum 215 is retained by a cover 217 that is sealed to the open end 203 of the container in a conventional manner to provide a leak- proof seal.
To protect the septum and maintain sterility of the surface of the needle-penetrable septum facing away from the interior of the container prior to use, a removable cover can be provided. The cover can be a foil film, and/or the cover can be affixed to the container around the septum. In some instances, the cover can define a tear portion in the form of a thinner or weakened region that allows the central portion of the cover to be removed. A tab can be provided to facilitate removal of a portion of the cover over the septum.
The container 200 further includes an adapter body 220 that includes a vent tube 221 and an inlet tube 223. The ends of the tubes are mounted over the corresponding fittings 207, 208 in a suitable manner to provide a permanent, leak-proof sealed engagement.
The vent tube 221 can preferably include a filter element 225 lodged within the tube. The filter element can be a micro filter, such as a 3 μηι sterile micro-filter. The micro-filter can be arranged to be gas permeable but generally impermeable to the liquid sample or cell suspension being stored within the container. Thus, the filter is capable of retaining the suspension within the container and venting gas out of the container when the container is being filled (either partially or completely) and venting gas into the container when suspension is being withdrawn from the container.
The inlet tube 223 can include a flared end 226 for engagement with a tube adapter. The inlet tube can include a needle penetrable septum. Alternatively, the inlet branch can be provided with a standard needle or needle-less port.
As mentioned above, the adaptor can be arranged such that an opening to the needle lumen is even with the adjacent inner surface of the container when the container is inserted
into the adaptor and the needle of the adaptor penetrates a wall of the container. For example, an opening to the needle lumen can be even with an adjacent inner surface of a needle penetrable septum of the container.
For the opening in the needle to be even, the opening can be defined at least by a first edge portion positioned on a first side of the inner surface and a second edge portion positioned on a second side of the inner surface and/or even with the inner surface. The inner surface can face towards the first edge portion and face away from the second edge portion. The needle can have an end opening and/or a plurality of side openings without or without a closed needle tip. The second edge portion can be positioned in the wall of the container (e.g., in the septum).
Advantageously, arranging the adaptor and/or container such that an opening of the needle is even with an adjacent inner surface of the needle penetrable septum can enable the withdrawal of substantially all of the fluid (e.g., excluding residual fluid adhered to the inner surface of the container) from the container. In many instances, the inner surface of the container (e.g., an inner surface of the septum) can taper towards the portion penetrated by the needle.
The adaptor can include a stop surface arranged to contact a portion of the container and limit the distance (e.g., depth) the needle can penetrate a wall of the container. In some instances, the stop surface limits the distance the container can be inserted into the adaptor. For example, the adaptor may include an inwardly projecting surface, such as surface 168, arranged to contact the container and prevent further insertion of the container into the longitudinal recess of the adaptor and the needle into the septum. The adaptor and/or container can be arranged such that when the container is received within the adaptor and contacting the stop surface, the needle of the adaptor protrudes through a wall of the container and has a needle opening even with an adjacent inner surface of the container.
Figure 5 illustrates a container received within the recess of an adaptor. With the container in contact with the stop surface 168, the inner surface 240 of the septum 215 is aligned with the opening 300 of the needle. For example, the opening of the needle can be defined at least by a first edge portion 302 positioned on a first side of (e.g., above) the inner surface 240 and a second edge portion 304 positioned on a second side of (e.g., below) the inner surface 240. As illustrated in figure 5, the needle opening can be an end opening.
However, it is also contemplated that the needle opening can be a side opening that is proximal the needle end, as illustrated in figure 6. In such instances, the needle tip 306 may
have an opening to the needle lumen or the needle tip may be closed, such as a crimped needle tip.
Any of the adaptors described herein can have any of a variety of connectors. For example, the adaptor may have a connector 150 being male luer connector 170 and/or a female luer connector 172 as shown in figures 7 and 8. These connectors are arranged to mate with, and the adaptors may be provided with, one or more other connectors 176 and/or tubing 180.
Adaptors described herein may include a second needle 186 (shown in figure 9) having a lumen in fluid communication with the lumen of the needle extending into the recess of the adaptor. The second needle can be arranged for tissue-penetration and/or septum penetration. Alternatively or additionally, the adaptor may include tubing 190 having a lumen in fluid communication with the lumen of the needle extending into the recess of the adaptor.
Kits, systems, and assemblies including an adaptor and a container (e.g., vial and/or syringe) wherein an opening of a needle of the adaptor aligns (e.g., is even) with an adjacent inner surface of the container when the adaptor and container are mated are envisioned. Kits and systems can be provided in sterile medical packaging (e.g., an adaptor and a container can be sealed in sterile medical packaging and packaged togeter).
Exemplary methods of use will now be described with reference to the adaptor and containers described above; however, such methods are not intended to be limited to such.
Use of a cryopreservation device can include introduction of a cell suspension into the container through the inlet branch, such as through the needle septum described above. As the cell suspension is injected into the container, the air within is vented through the filter in the vent branch. Once the container is partially or completely filled, the two branches can be heat sealed, using for instance a heated pinch sealer, so that the container is hermetically sealed. Of course it is understood that the needle septum and cover can remain intact as the container is filled. Once filled to the desired level and sealed, the container can be
cryogenically stored.
When it is desired to withdraw the cell suspension, the container and contents are first thawed. Once thawed, a cover may be removed to expose the septum on the bottom end of the container. The vent branch is severed between the sealed portion and the filter element to open the vent passageway. A portion of the container is then positioned within the longitudinal recess of the adaptor so that the needle of the adaptor penetrates a wall of the container sufficient to place a lumen of the needle in communication with contents of the
container. The cell suspension can then be withdrawn through the needle lumen into a syringe or other device (e.g., medical tubing).
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes, equivalents, and modifications that come within the spirit of the inventions defined by following claims are desired to be protected. All publications, patents, and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.
The language used in the claims and the written description is to only have its plain and ordinary meaning, except for terms explicitly defined below. Such plain and ordinary meaning is defined here as inclusive of all consistent dictionary definitions from the most recently published (on the filing date of this document) general purpose Merriam- Webster dictionary.
As used in the claims and the specification, the following terms have the following defined meanings:
The term "container" as used herein means an object that can be used to hold or transport a liquid. The term includes, but is not limited to, containers having rigid walls, such as syringes and vials.
The terms "fill" and "filling" as used herein include complete fill/filling and partial fill/filling of a container.
The term "syringe" as used herein has the ordinary and customary meaning as understood by those in the medical field. The term includes a container having an internal chamber of variable volume, such as a chamber defined at least in-part by a movable piston. The piston can be useful to draw fluid into the chamber of the syringe and/or expel fluid from the chamber (e.g., to inject fluids into a patient's body).
The term "vial" as used herein has the meaning, a small container arranged to hold liquid and allow for subsequent withdrawal of the liquid. This includes, but is not limited to, containers having a fixed. The volume of the container can be 10 mL or less or 6 mL or less. The term also includes rigid-wall containers, such as a container with a glass or rigid-plastic wall. The vials described herein include vials for cryopreservation. The term includes the vials described and/or illustrated in U.S. Patent No. 7,939,316 published on May 10, 2011;
U.S. Patent No. 8,222,027 published on July 17, 2012; PCT Publication No. WO 2013/023075 published on April 4, 2013; U.S. Patent No. 8,936,905 published on January 20, 2015; U.S. Publication No. 2015/0140650 published on May 21, 2015; U.S. Patent No.
9,565,854 published on February 14, 2017; and U.S. Publication No. 2017/0099832 published on April 13, 2017. The term includes vials having a tubular body with a needle- penetrable septum so as to allow for aseptic withdrawal of fluid from inside the tubular body. Certain vials may include one or more tubes extending from the tubular body, the first and second tubes communicating with the interior of the tubular body. The first and second tubes may be heat sealable. In some instances, the first tube can have a Luer fitting. Additionally or alternatively, the second tube can include a sterile filter, such as an anti-microbial filter. The filter can have a nominal micron rating between about 10 and 0.1 microns. In some instances, the filter has a nominal micron rating between 5 and 0.1 microns and/or between about 3 and 0.2 microns. The first and second tubes can extend from an end of the vial opposite of a needle -penetrable septum.
The term "vent" as used herein means an opening to allow equalization of gas pressure between the inside and outside of the container. Vents may allow the passage of gas through the vent (e.g., through a microfilter) and/or include a flexible membrane (e.g., a bag and/or balloon) that allows for expansion and/or contraction of gas within the container.
The term "well" as used herein means a depression for holding a liquid. The term includes, but is not limited to, recessed areas such as valleys, troughs, and bowls, just to name a few non-limiting examples. A well may be defined by one or more curved surfaces and/or intersecting surfaces.
The following numbered clauses set out specific embodiments that may be useful in understanding the present invention:
1. An adaptor for a container, comprising:
an adaptor body defining a recess arranged to receive a portion of the container;
a needle extending into the recess and arranged to penetrate into the portion of the container when the portion is received in the recess; and
a stop surface arranged to contact the container to control the depth the needle can be inserted into the container such that an opening of the needle is even with an inner surface of the container when the container contacts the stop surface.
2. The adaptor of clause 1, wherein:
the opening of the needle has a first edge portion positioned on a first side of the inner surface and a second edge portion positioned in-line-with the first side of the inner surface or on a second side of the inner surface when the container contacts the stop surface. 3. The adaptor of clause 2, wherein:
the second edge portion is positioned on the second side of the inner surface when the container contacts the stop surface.
4. The adaptor of any preceding clause, wherein:
the opening is a side-opening in the needle.
5. The adaptor of any preceding clause, wherein:
the needle has a closed tip. 6. The adaptor of any preceding clause, wherein:
the stop surface extends in a direction transverse to a longitudinal axis of the needle.
7. The adaptor of any preceding clause, wherein:
the adaptor body defines a window arranged to allow visualization of the container when the portion of the container is positioned within the recess.
8. The adaptor of any preceding clause, comprising
a locking portion arranged to cooperate with a locking portion of the container so as to lock the container and adaptor to one another.
9. The adaptor of any preceding clause, comprising:
a connector defining a lumen in fluid communication with a lumen of the needle.
10. The adaptor of clause 9, wherein:
the connector includes a valve that closes the lumen of the connector and opens when the connector is connected with another connector.
11. An assembly comprising the adaptor of any preceding clause with the container received within the recess thereof.
12. The assembly of clause 11, wherein the inner surface of the container defines a well and the opening of the needle has portion positioned in the well when the container contacts the stop surface of the adaptor.
13. The assembly of any one of clauses 11-12, wherein the container is a syringe. 14. The assembly of any one of clauses 11-12, wherein the container is a vial.
15. The assembly of clause 14, wherein:
the portion of the vial received within the adaptor has a needle -penetrable septum and the vial has a vent at an end opposing the needle -penetrable septum.
16. A system, comprising:
a container having a first end with a needle penetrable septum; and
an adaptor having a recess arranged to receive the first end of the container;
the adaptor having a needle extending into the recess and arranged to penetrate the needle penetrable septum when the first end of the container is received in the recess; and the adaptor having a stop surface arranged to contact the container to control the depth the needle can be inserted into the container;
wherein the needle has an opening in a sidewall of the needle; and
wherein at least a portion of the opening is in the needle -penetrable septum when the container contacts the stop surface of the adaptor.
17. The system of clause 16, wherein:
the opening of the needle crosses an inner surface of the container when the container contacts the stop surface.
18. The system of any one of clauses 16 or 17, wherein:
the opening of the needle has portion positioned in a well defined by an inner surface of the container when the container contacts the stop surface of the adaptor.
The system of clause 18, wherein:
the container defines an internal chamber and the well is defined by a tapered portion ternal chamber. The system of clause 19, wherein:
the needle penetrable septum defines the tapered portion.
Claims
1. An adaptor for a container, comprising:
an adaptor body defining a recess arranged to receive a portion of the container; a needle extending into the recess and arranged to penetrate into the portion of the container when the portion is received in the recess; and
a stop surface arranged to contact the container to control the depth the needle can be inserted into the container such that an opening of the needle is even with an inner surface of the container when the container contacts the stop surface.
2. The adaptor of claim 1, wherein:
the opening of the needle has a first edge portion positioned on a first side of the inner surface and a second edge portion positioned in-line-with the first side of the inner surface or on a second side of the inner surface when the container contacts the stop surface.
3. The adaptor of claim 2, wherein:
the second edge portion is positioned on the second side of the inner surface when the container contacts the stop surface.
4. The adaptor of any preceding claim, wherein:
the opening is a side-opening in the needle.
5. The adaptor of any preceding claim, wherein:
the needle has a closed tip.
6. The adaptor of any preceding claim, wherein:
the stop surface extends in a direction transverse to a longitudinal axis of the needle.
7. The adaptor of any preceding claim, wherein:
the adaptor body defines a window arranged to allow visualization of the container when the portion of the container is positioned within the recess.
8. The adaptor of any preceding claim, comprising
a locking portion arranged to cooperate with a locking portion of the container so as to lock the container and adaptor to one another.
9. The adaptor of any preceding claim, comprising:
a connector defining a lumen in fluid communication with a lumen of the needle.
10. The adaptor of claim 9, wherein:
the connector includes a valve that closes the lumen of the connector and opens when the connector is connected with another connector.
11. An assembly comprising the adaptor of any preceding claim with the container received within the recess thereof.
12. The assembly of claim 11, wherein the inner surface of the container defines a well and the opening of the needle has portion positioned in the well when the container contacts the stop surface of the adaptor.
13. The assembly of any one of claims 11-12, wherein the container is a syringe.
14. The assembly of any one of claims 11-12, wherein the container is a vial.
15. The assembly of claim 14, wherein:
the portion of the vial received within the adaptor has a needle -penetrable septum and the vial has a vent at an end opposing the needle -penetrable septum.
16. A system, comprising:
a container having a first end with a needle penetrable septum; and
an adaptor having a recess arranged to receive the first end of the container;
the adaptor having a needle extending into the recess and arranged to penetrate the needle penetrable septum when the first end of the container is received in the recess; and the adaptor having a stop surface arranged to contact the container to control the depth the needle can be inserted into the container;
wherein the needle has an opening in a sidewall of the needle; and
wherein at least a portion of the opening is in the needle -penetrable septum when the container contacts the stop surface of the adaptor.
17. The system of claim 16, wherein:
the opening of the needle crosses an inner surface of the container when the container contacts the stop surface.
18. The system of any one of claims 16 or 17, wherein:
the opening of the needle has portion positioned in a well defined by an inner surface of the container when the container contacts the stop surface of the adaptor.
19. The system of claim 18, wherein:
the container defines an internal chamber and the well is defined by a tapered portion of the internal chamber.
20. The system of claim 19, wherein:
the needle penetrable septum defines the tapered portion.
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US201762577209P | 2017-10-26 | 2017-10-26 | |
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