WO2006076492A2 - Dispositif et procede de transfert et de reconstitution - Google Patents

Dispositif et procede de transfert et de reconstitution Download PDF

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Publication number
WO2006076492A2
WO2006076492A2 PCT/US2006/001080 US2006001080W WO2006076492A2 WO 2006076492 A2 WO2006076492 A2 WO 2006076492A2 US 2006001080 W US2006001080 W US 2006001080W WO 2006076492 A2 WO2006076492 A2 WO 2006076492A2
Authority
WO
WIPO (PCT)
Prior art keywords
receptacle
cannula
main body
passageway
receiving portion
Prior art date
Application number
PCT/US2006/001080
Other languages
English (en)
Other versions
WO2006076492A3 (fr
Inventor
Helen Shi Liu
John Pipinias
Steven Tortorella
Original Assignee
Whatman, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Whatman, Inc. filed Critical Whatman, Inc.
Publication of WO2006076492A2 publication Critical patent/WO2006076492A2/fr
Publication of WO2006076492A3 publication Critical patent/WO2006076492A3/fr

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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
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix 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
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • 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
    • 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
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration
    • 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
    • A61J1/2079—Filtering means
    • A61J1/2086—Filtering means for fluid filtration
    • 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

Definitions

  • the present invention relates generally to transfer devices and methods for mixing substances. More particularly, the apparatus and method of the present invention concern transferring a first substance into a container containing a second substance, mixing the first substance and second substance and delivering the resulting mixture aseptically to a delivery device.
  • Reconstitution is often necessary prior to the administration of a therapeutic agent to a patient.
  • reconstitution typically consists of injecting an appropriate diluents into a container previously filled with a predetermined quantity of a therapeutic agent and mixing the therapeutic agent with the diluents substance. The resulting mixture then is transferred into a syringe or other transfer device for administration to the patient orally, by injection or otherwise.
  • Contamination in the administration of reconstituted medicines may result in serious complications to patients. Specifically, such contamination has been found to result from breaches of sterile conditions or particulates that are not completely dissolved during the reconstitution process among other sources. This problem has been found to be particularly acute in the self-administration of medicines in a home-care environment.
  • U.S. Pat. 6,558,365 describes a fluid transfer device that includes a plastic spike for piercing elastomeric seals found on typical medicine containers, and an adapter that is used to shield the plastic spike and to receive the container.
  • Two of these devices apparently may be connected to one another so as to form a liquid flow pathway through the respective spikes that may be used in the course of drug reconstitution.
  • the connected devices are disconnected, and a needleless syringe is connected with one of the devices to transfer the resultant mixture.
  • this disclosure does not provide any particular capturing mechanisms to prevent solid particles from entering into the syringe or other forms of contamination.
  • U.S. Pat. 6,238,372 describes another fluid transfer device.
  • that device includes a housing that contains three ports, one for receiving a syringe, one for establishing a liquid flow path into a medicine container, and one for fluid transfer.
  • two of the ports are connected for reconstitution.
  • this device has been found to be too bulky and awkward to be handled conveniently during reconstitution.
  • a third port is needed for fluid transfer thereby complicating the reconstitution process.
  • U.S. Pat. 5,743,312 describes yet another drug reconstitution device, but fails to include any fluid transfer mechanism. Accordingly, a conventional syringe is required to transfer the mixture according to the latter disclosure.
  • European Patent No. 0 521 460 Al describes a fluid transfer device that can be used for both reconstitution and transfer purposes. That device is designed to include a filtration mechanism for the purpose of keeping the drug environment sterile and preventing undesired large particles from entering into the syringe or other transfer device. Therefore, the main drawbacks of this design are that it also is bulky and awkward, and that it is so complex that its manufacture is a challenging task.
  • a reconstitution and transfer device in a preferred embodiment of the present invention, includes a main body, and first and second receptacle receivers connected with the main body such that the interiors of receptacles engaging the respective receptacle receivers are connected to one another through a passageway through the main body. More specifically, lumens of first and second piercing cannulas are connected respectively with a first passageway through the main body such that the piercing cannulas are capable of piercing typical seals covering the open ends of receptacles received by the respective receptacle receivers and transferring a substance from one of the receptacles to the other therethrough.
  • a side opening associated with a sidewall of the main body between its ends is provided which is adapted to have a closure member removeably disposed therein.
  • This side opening when the closure member is disassociated from the main body, is capable of releasing a reduced pressure in a receptacle which is adapted to receive a substance from the other receptacle through the second passageway through the main body to the surrounding atmosphere in order to facilitate the aspiration of the mixed substances contained therein into a transfer device.
  • the present invention provides an apparatus for mixing a first substance contained within a first receptacle (typically a liquid) with a second substance (typically a powder) contained within a second receptacle under reduced pressure.
  • the first and second receptacles each respectively include a sealed open end.
  • the apparatus of the present invention is adapted to facilitate a transfer of the resultant mixture to an aspirator.
  • the apparatus of the present invention generally includes a main body portion having a longitudinal axis, a peripheral surface, and opposing first and second ends.
  • the main body portion defines a first substantially longitudinal passageway connecting the first " end of the main body to its second ' end and a second passageway connecting the second end of the main body to an opening in its peripheral side surface.
  • a first receptacle receiver is located at the first end of the main body and a second receptacle receiver is located at the second end of said main body, the first and second receptacle receivers being substantially centered on the longitudinal axis and adapted to respectively receive and releasably hold at least the sealed open ends of the first and second receptacles.
  • a first piercing cannula is removeably connected with the main body adjacent the first end of the main body so as to extend substantially along the longitudinal axis of the main body into the first receptacle receiver.
  • the first cannula defines a longitudinal lumen connecting an outer piercing end that is surrounded by the peripheral walls of the first receptacle receiver with the first passageway through the main body.
  • a second piercing cannula extends substantially longitudinally from the second end of the main body into the second receptacle receiving portion.
  • the second cannula defines a pair of substantially parallel longitudinal lumens that respectively connect an outer piercing end that is surrounded by the peripheral walls of the second receptacle receiver with the first passageway and the second passageway, respectively.
  • a closure member is removably associated with the second passageway at its opening into the peripheral surface of said main body.
  • a sterile air filter extends across the second passageway substantially adjacent to a cavity in the peripheral wall of the main body adapted to removeably receive the closure member.
  • a first particle- capturing filter extends across the lumen of the first cannula substantially adjacent to its connection with the first passageway.
  • a second particle-capturing filter extends across the first passageway substantially adjacent to its connection to the lumen of the first cannula.
  • the peripheral walls of the first and second receptacle receivers are adapted to substantially elastically deflect outwardly so as to allow the secure, yet removable, receipt of a sealed open end of one of the receptacles in the cavity formed thereby.
  • the peripheral walls may, for example, define a plurality of circumferentially spaced longitudinal slots and inwardly extending projections adjacent the outer edge of each of the portions of the peripheral wall between each pair of longitudinal slots for releaseably retaining a sealed open end of a receptacle in the cavity formed thereby.
  • the peripheral wall of the first receptacle receiver may be as just described (i.e., include circumferentially spaced, longitudinal slots) while the peripheral wall of the second receptacle receiver defines instead of the above-mentioned longitudinal slots having inwardly extending projections therebetween, an inwardly extending projection adjacent to its outer edge and a slot that extends longitudinally toward the main body from its outer edge to one end of a substantially circumferentially disposed slot that extends approximately one-halfway around the circumference of the second receptacle receiver.
  • a second receptacle defining a projection receiving portion adjacent to its sealed open end may be easily, yet securely, inserted into the second receptacle receiver by virtue of the resilient movability of the outer circumferential portion of the peripheral wall of the second receptacle receiver located between the circumferentially extending slot and the outer edge of the peripheral wall.
  • this construction further facilitates the secure, yet removable, disposition of a second receptacle in the second receptacle receiver in the present invention in those cases in which it is important to load the second receptacle receiver quickly in order to avoid liquid loss from the first receptacle and to maintain the reduced pressure in the second receptacle for drawing the first substance into the second receptacle through the first passageway through the main body.
  • the first receptacle and the cannula extending longitudinally into the first receptacle receiver are to be removable from the first receptacle receiver together.
  • the removal of these elements together from the first receptacle receiver provides immediate open access to the first passageway through the main body and thence to the interior of the second receptacle for the aspiration of the mixed substances from the first end of the main body through the longitudinal passageway.
  • the first receptacle receiver defines a central, hollow, cylindrical portion surrounding a longitudinal projection of the first passageway into the first receptacle receiver having a threaded external surface.
  • the first cannula is mounted on a fitting defining a central passageway connecting the lumen of the first cannula with the first passageway of the main body. That fitting includes a first portion adapted to screw onto the exterior of the hollow, cylindrical portion just described and a second portion adapted to project into the central hollow portion of the longitudinally cylindrical portion (i.e., a so-called Luer fitting).
  • the fitting just mentioned defines a plurality of radially extending projections substantially adjacent the location at which the cannula enters the fitting. Each of these projections is adapted to pierce the seal of a receptacle inserted into the first receptacle receiver adjacent to the location at which the first cannula pierces that seal.
  • the result of this construction is that axial rotation of the first receptacle mounted in the first receptacle receiver causes the projections adjacent to the joinder of the first cannula to its mounting fitting to bear circumferentially against the seal. In this way, the fitting may be unscrewed from the cylindrical portion by axial rotation of the first receptacle. Also, by virtue of the tight frictional engagement of the cannula and the radial projections with the seal, the first cannula, its associated fitting and the first receptacle can be easily removed from the first receptacle receiver together.
  • the opening from the first receptacle receiver into the first passageway through the hollow longitudinal projection adjacent to the base of the first receptacle receiver is immediately available for the receipt of an aspirator (such as a syringe) for drawing the mixed substances out of the second receptacle mounted in the second receptacle receiver.
  • an aspirator such as a syringe
  • the fitting adapted to mount the first cannula onto the central cylindrical hollow portion may include a handle extending substantially radially outwardly from the fitting through a slot in the peripheral wall of the first receptacle receiver to an outer handle end.
  • the longitudinal slots in the peripheral wall of the first receptacle receiver are replaced with a slot that extends in a spiral toward said main body from an inner end of a longitudinal slot that extends from the outer edge of the peripheral wall a preselected distance toward said main body.
  • This construction permits movement of the handle from a closed end of the spiral slot when the fitting fully engages the hollow cylindrical projecting portion in the first receptacle receiver along the spiral slot in a manner that acts to unscrew the fitting from the cylindrical hollow portion.
  • the pitch of the threads of the engaged fitting and those of the exterior of the hollow cylindrical portion are matched with the spiral of the slot in the peripheral wall of the first receptacle receiver such that when the handle reaches the inner end of the longitudinal slot, the fitting is fully released from its threaded engagement with the longitudinally extending cylindrical portion.
  • the fitting, the first cannula and the first receptacle can be removed from the first receptacle receiving portion together with the assistance of the handle portion guided outwardly through the longitudinal slot portion of the slot formed in the peripheral wall of the first receptacle receiver.
  • the method for mixing a first substance contained within a first receptacle with a second • substance contained under reduced pressure within a second receptacle, the first and second receptacles each respectively having an opening sealed with a pierceable seal, and for facilitating a transfer of the resultant mixture to an aspirator or other delivery device now will be summarized.
  • a sealed end of a first receptacle containing a first substance is inserted into the first receptacle receiver such that the first cannula pierces the sealed end of the first receptacle and the first receptacle is releasably held in the first receptacle receiving portion. This is usually accomplished with the first receptacle in an upright position (i.e., with its sealed open end facing upwardly).
  • a sealed end of the second receptacle is inserted into the second receptacle receiver such that the second cannula pierces the sealed end of the second receptacle and the second receptacle is releasably held in the second receptacle receiver.
  • the substance in the first receptacle is a liquid, that substance will tend to leak out of the first passage through the main body as the second receptacle is mounted in the second receptacle receiver. Accordingly, a quick and sure mounting of the second receptacle is desired, even though the first passageway diameter is small thereby limiting the volume of the first substance that flows therethrough per unit time.
  • the apparatus having the first and second receptacles mounted in the first and second receptacle receivers is inverted so as to place the first receptacle in an upside down position.
  • the first substance is typically a liquid and the second substance is typically a powder, but the nature of the substances may vary from this so long as the first substance can flow through the first cannula into the longitudinal passageway in the main body and thence through the second cannula into the second receptacle.
  • the first substance contained in the first receptacle is transferred into the second receptacle through the first passageway and second cannula by gravity and under the applied drawing force of the reduce pressure in said second receptacle.
  • the first receptacle is mounted in the first receptacle receiving portion and thereafter the second receptacle is mounted in the second receptacle receiving portion such that upon the piercing of the seal of the second receptacle the reduced pressure therein provided by the manufacturer of the medicinal or other material contained therein creates a drawing force that pulls the first substance from the first receptacle into the second receptacle with sufficient force to cause a mixing of the first and second substances within the second receptacle.
  • the second receptacle may be shaken while mounted in the apparatus to complete satisfactory mixing of the first and second substances.
  • the closure member associated with the opening in the peripheral wall to the second passageway in the main body is removed or otherwise opened.
  • the first cannula, its associated fitting and said first receptacle are removed together from the first receptacle receiver by unscrewing the fitting holding the first cannula from the hollow cylindrical projection at the base of the first receptacle receiver and pulling the cannula, the fitting and the first receptacle out of the first receptacle receiving portion thereby disengaging any locking engagement or other feature tending to retain the open end of the first receptacle within the first receptacle receiving portion) as generally discussed above.
  • the fitting portion of an aspirator such as a syringe is attached to the hollow cylindrical portion at the base of the first receptacle receiver and the mixed first and second substances in the second receptacle are drawn out of the second receptacle into the reservoir of the aspirator.
  • the open second passageway assures the equalization of the pressure inside the second receptacle with the outside during aspiration of the mixed first and second substances. This acts to avoid the potential for the creation of an air pressure lock in the second receptacle/first passageway that could prevent satisfactory aspiration of the mixed substances.
  • Fig. IA is an exploded side elevation of a first embodiment of an apparatus in accordance
  • Fig. IB is a cross sectional view taken along the line A-A of the first embodiment of the
  • Fig. 2 A is a side elevation of the first embodiment of the apparatus in accordance with
  • Fig. 2B is a cross sectional view taken along the line A-A of the first embodiment of the
  • Fig. 3 A is a side elevation of the first embodiment of the apparatus in accordance with
  • Fig. 3B is a cross-sectional view taken along the line A-A of Fig. 3 A;
  • Fig. 4 A is a side elevation of the first embodiment of the apparatus in accordance with
  • Fig. 4B is a cross sectional view taken along the line A-A of Fig. 4A;
  • Fig. 5 A is a side elevational view of the apparatus in accordance with the invention of
  • Fig. 5B is a cross sectional side view taken along the line A-A of Fig. 5 A;
  • Fig. 6 A is a side elevational view of the first embodiment of the apparatus in accordance
  • Fig. 5 including a syringe-type aspirator engaging the Luer
  • Fig. 6B is a cross sectional side view taken along the line A-A of Fig. 6 A;
  • Figs 7A to 7D are representative depictions of four possible configurations of the
  • Fig. 8 A is an exploded side elevation of a second embodiment of the apparatus in
  • Fig. 8B is a cross sectional view taken along the line A-A of the second embodiment of
  • Fig. 9 A is a side elevation of the second embodiment of the apparatus in accordance with
  • Fig. 9B is a cross sectional view taken along the line A-A of the second embodiment of
  • Fig. 1OA is a side elevation of the second embodiment of the apparatus in accordance
  • Fig. 1OB is a cross-sectional view taken along the line A-A of Fig. 1OA;
  • Fig. 1 IA is a side elevation of the second embodiment of the apparatus in accordance
  • Fig. 1 IB is a cross sectional view taken along the line A-A of Fig. 1 IA;
  • Fig. 12A is a side elevational view of the second embodiment of the apparatus in
  • Fig. 12B is a cross sectional side view partially cut away taken along the line A-A of
  • Fig. 12A; Fig. 13 A is a side elevational view of the second embodiment of the apparatus in
  • Fig. 12A including a syringe-type aspirator
  • Fig. 13B is a cross sectional side view taken along the line A-A of Fig. 13 A;
  • Fig. 14A is an exploded side elevation of a third embodiment of the apparatus in
  • Fig. 14B is a cross sectional view taken along the line A-A of the third embodiment of
  • Fig. 15A is a side elevation of the third embodiment of the apparatus in accordance with
  • Fig. 15B is a cross sectional view taken along the line A-A of the third embodiment of
  • Fig. 16A is a side elevation of the third embodiment of the apparatus in accordance with
  • Fig. 16B is a cross-sectional view taken along the line A-A of Fig. 16 A;
  • Fig. 17A is a side elevation of the third embodiment of the apparatus in accordance with
  • Fig. 17B is a cross sectional view taken along the line A-A of Fig. 17 A;
  • Fig. 18A is a side elevational view of the third embodiment of the apparatus in
  • Fig. 18B is a cross sectional side view taken along the line A-A of Fig. 18 A;
  • Fig. 19A is a side elevational view of the third embodiment of the apparatus in
  • Fig. 18A including a syringe-type aspirator
  • Fig. 19B is a cross sectional side view taken along the line A-A of Fig. 19A.
  • the present invention relates to an apparatus and method for transferring a first substance contained in a first container into a second container containing a second substance, mixing the first and second substances and delivering the resulting mixture aseptically to a delivery device.
  • a first substance contained in a first container into a second container containing a second substance, mixing the first and second substances and delivering the resulting mixture aseptically to a delivery device.
  • common elements will be referred to throughout by the same reference numerals for the sake of ease of understanding.
  • a first receptacle 56 for use with the present invention contains a liquid substance 60 and includes an upper, generally cylindrically shaped portion 62 including an undercut portion 62a.
  • a second receptacle 58 contains a solid substance (typically a powder) 66 under reduced pressure or partial vacuum conditions, and includes an upper, generally cylindrically shaped portion 68 having an undercut portion 68a.
  • the generally cylindrical portions 62 and 68 closely fit within first and second receptacle receivers 14 and 12, respectively, as will be discussed in further detail below.
  • the receptacles 56 and 58 are contemplated to be of conventional, commonly commercially available construction including a seal or stopper, 64 and 70, that seals the open upper end of the generally cylindrically shaped upper portion, 62 or 68, of the receptacle 56 or 58.
  • the seals or stoppers 64 and 70 may be formed entirely of polymeric material suitable for the formation of a closure of the central portion of the open ends of the containers 56 and 58 that may be pierced with a needle or other thin pointed element.
  • a plastic or metal cap portion defining a central opening could be used to clamp a pierceable membrane across the open end of each of the receptacles 56, 58.
  • a first preferred embodiment of the apparatus of the invention includes a main body 10 and receptacle receivers, 12 and 14, extending outwardly from opposite ends of the body 10.
  • the receptacle receivers, 12 and 14 are hollow cavities formed by peripheral walls 16, 18 that may define a plurality of circumferentially spaced longitudinal slits, generally indicated at 20 or 22, extending from the outer peripheral edge of each receptacle substantially all the way to the adjacent end of the main body 10. Accordingly, each portion of the peripheral wall of the receptacle can flex outwardly about its attachment to the main body 10.
  • receptacle locking members in the form substantially radially inwardly extending ridges, 24 and 26, are located substantially adjacent to the outer edges of the wall portions 16, 18 defining the receptacle receivers, 12 and 14, respectively. These locking members in conjunction with the flexibility of the wall portions allow the receptacle receivers, 12 and 14, to securely engage the upper portion of the receptacles 56 and 58 adjacent their open ends 62, 68.
  • the open ends 62, 68 of receptacle receivers, 12 and 14 can have the same or different diameters according to the size(s) of the open receptacle receivers provided.
  • a second piercing cannula 34 extends from the main body 10 so as to protrude into the second receptacle receiver 12.
  • the second piercing cannula 34 defines multiple (here 2) internal lumens; specifically transfer lumen 36 and venting lumen 38.
  • a substantially cylindrical, hollow, connecting portion 40 extending from the main body 10 so as to protrude into the first receptacle receiver 14 is a substantially cylindrical, hollow, connecting portion 40.
  • the transfer lumen 36 is aligned and communicates with the first connecting portion 40 via a first passageway 72 extending substantially along the longitudinal axis of the main body from its first end to its second end.
  • the venting lumen 38 communicates with a side opening 42 in the peripheral surface of the main body 10 via a second passageway 47.
  • a first filter 44 is located between the transfer lumen 36 and the first connecting portion 40 internally of the main body 10. Specifically, the first filter 44 is disposed adjacent the base of the first receptacle receiver 14 so as to extend across the first passageway 72 and also across the base of the hollow interior of the substantially cylindrical connecting portion 40. In addition, a second filter 46 is disposed across the second passageway 47 at the inner end of the side opening 42.
  • a closure member 48 (such as the rubber cap depicted in the drawings) is removeably inserted into the side opening 42.
  • the closure member 48 acts to substantially preserve a pressure difference between the reduced pressure interior of the second receptacle 58 and the interior of the first receptacle 56 during their connection with one another and the transfer of the first substance from the first receptacle to the second receptacle, as will be described more fully below.
  • the closure member 48 is removable from the side opening 42 to allow air to flow through the venting lumen 38 and into the second receptacle 58 during the aspiration of the mixed substances from the second receptacle, also as will be described more fully below.
  • a first piercing cannula 50 is connected to the first connecting portion 40.
  • the first piercing cannula 50 includes a piercing outer end, an internal lumen 52, a plurality of sharp features 51 adapted secure an inner end of the piercing cannula to the outer surface of the seal 64 of a first receptacle 56 mounted in the first receptacle receiver 14, and connecting elements 54a and 54b forming part of a fitting for attaching the first piercing cannula to said first connecting portion 40.
  • the sharp features 51 are thin, substantially planar members that are aligned substantially parallel with the longitudinal axis of the first piercing cannula so as to extend radially outwardly therefrom adjacent to the portion thereof connecting the cannula to the projecting portion 40. These sharp features 51 are adapted to pierce the seal 64 of the receptacle 56 inserted into the first receptacle receiver 14 adjacent to the opening therein formed by the cannula 50 when the cannula 50 is fully inserted into the receptacle receiver 14. These sharp features 51 establish a secure, non-rotatable attachment of the cannula to the pierced seal 64 (see, Figs. 3B and 4B).
  • first connecting portion 40 is preferably provided in the form longitudinally extending, hollow, cylindrical projection into the first receptacle receiver 14 from the adjacent end of the main body 10, while the connecting elements 54a and 54b form a Luer connector adapted to mate respectively with the exterior and interior of the connecting portion 40.
  • connecting element 54b defines a longitudinal opening that communicates with the lumen of the first cannula 50 and is inserted into the hollow portion of the connecting portion 40, while threads located on the connecting portion 54a engage a threaded portion on the outer surface of the connecting portion 40.
  • the first piercing cannula 50 includes a fitting at its inner end having a central portion that frictionally engages the interior of the connecting portion 40 in telescoping relation therewith, while an outer portion thereof screws onto the connecting portion 40 in engagement with its outer surface.
  • the threads on the outer surface of the connecting portion 40 are configured such that they also mate with fittings on various aspirators such as those having connectors of the type found on conventional and readily commercially available needleless syringes and the like (see, for example, Fig. 6B). Accordingly, as shown in Figs.
  • the first piercing cannula 50 is adapted to extend into the first receptacle 56 through its seal when the first receptacle is mounted in the first receptacle receiver 14.
  • the first receptacle 56 includes a container portion that is filled with a first substance, typically a liquid substance 60 as shown in the drawings, and an upper, generally cylindrical shaped portion 62 that is sealed by an elastomeric plug or the like 64 as described above.
  • Receptacle 56 is of a type that is of conventional construction and is readily commercially available, usually as the container in which the substance is packaged by its manufacturer or distributor.
  • the first piercing cannula 50 pierces the seal 64 to open communication between the container portion of the receptacle 56 and the hollow interior of the connecting portion 40 and thence to the first passageway 72 through the main body 10 as the receptacle is inserted into the first receptacle receiver 14.
  • the second receptacle 58 mates with the second receptacle receiver 12.
  • the second receptacle 58 includes a container portion that typically contains a powdered, solid substance 66 under reduced pressure or vacuum conditions, and an upper, generally cylindrical shaped, open topped portion 68 that is sealed by a sealing member 70.
  • Receptacle 58 is also of conventional construction and is readily commercially available.
  • the second piercing cannula 34 pierces the sealing member 70 to open communication between container portion of the receptacle 58 and the first passageway 72 through the main body 10 as the second receptacle is inserted into the second receptacle receiver 12.
  • the present invention can function with or without the peripheral walls that surround the piercing cannulas 34 and 50, respectively.
  • the receptacle receiverl2 can have depth that is larger or smaller than the length of piercing cannula 34 and/or the receptacle receiver 14 can have a depth that is larger or smaller than the combined assembled length of piercing cannula 50 and connecting portion 40. It is preferred, however, that peripheral walls 16, 18 are provided, and that those walls exceed the length of cannulas 34 and 50 respectively so as to shield the pointed tips of the cannulas from the surrounding environment and protect users from needlepoint injury.
  • Fig 7 A shows the piercing cannula 34 with venting lumen, 38, opening on the side
  • Fig 7B shows the piercing cannula 34 with transferring lumen, 36, opening on the side
  • Fig 7C shows the piercing cannula 34 with both venting and transferring lumens, 36 and 38, openings on the side
  • Fig 7D shows the piercing cannula 50 with internal lumen, 52, opening on the side.
  • the positions of the lumen openings are a matter of design choice that can vary along the lengthwise direction of the piercing cannula, 34 or 50 according to the dictates of the remainder of the structure into which they are to be incorporated.
  • Fig 2 shows side opening 42 entering the sidewall of the main body 10 substantially perpendicularly to the longitudinal axis of the main body 10.
  • the side opening 42 can be disposed at an angle other than perpendicular to the longitudinal axis of the main body 10 without departing from the present invention in its broadest aspects.
  • the side opening 42 does not have to enter the sidewall of the main body at all.
  • the side opening may be defined by projections extending outwardly from the side wall of the main body that form a cavity adapted to hold the closure member, the cavity being in communication with the second receptacle receiver 12 via the second passageway 47 through the main body 10 and lumen 38 in the cannula 32.
  • the configuration of the various filters in the apparatus also can be varied without departure from the present invention. Accordingly, while Fig 2 shows a preferred embodiment that utilizes the three filters, 44, 32 and 46, alternative embodiments of the present invention can have none, one, or any combination of two of the three filters discussed above without departure from the present invention in its broadest aspects. Furthermore, other alternative embodiments could include more than the three filters of the preferred embodiment discussed above and/or any combination thereof.
  • the specific nature of the sharp feature 51 also is variable without departure from the present invention.
  • the preferred embodiment discussed above uses plurality of fin-like elements that partially pierce the seal 64
  • alternative configurations such as a single fin, a spike, a plurality of spikes, and the selection of the material of the piercing cannula 50 such that it will generate enough friction with the sides of the pierced opening in the seal to hold the position of the cannula fixed relative to the seal, all such that the first piercing cannula 50 will turn so as to disengage the fitting 56a, 56b from the connecting portion 40 protruding from the main body 10 when the first receptacle 56 is rotated are contemplated within the scope of the present invention in its broadest aspects.
  • Fig 2 shows the preferred Luer type connection, but any means that can connect the piercing cannula 50 with the connecting portion 40 in a functionally equivalent manner are equally applicable as alternative embodiments of the present invention.
  • the fitting 100 adapted to mount the first cannula 50 onto the cylindrical hollow portion 40 in the first receptacle receiver 14 may include a handle 102 extending substantially radially outwardly from the fitting through a slot 104 in the peripheral wall of the first receptacle receiver 14 to an outer handle end 106.
  • the longitudinal slots in the peripheral wall of the second receptacle receiver 12 are retained, but in the first receptacle receiver 14 the slot 104 replaces those longitudinal slots.
  • Slot 104 extends in a spiral generally indicated at 107 in Fig.
  • the thread pitches of the engaged fitting 100 and the exterior of the hollow cylindrical connecting portion 40 are matched with the pitch of the spiral of the slot 104 in the peripheral wall of the first receptacle receiver 14 such that when the handle 102 reaches the inner end 108 of the longitudinal slot 104 (i.e., the inner end of the longitudinal slot portion), the fitting is fully released from its threaded engagement with the hollow, cylindrical connecting portion 40.
  • the fitting 100, the first cannula 50 and the first receptacle 56 can be removed from the first receptacle receiver 14 together with the assistance of the handle portion 102 guided outwardly through the longitudinal slot portion 110 of the slot formed in the peripheral wall of the first receptacle receiver 14.
  • the peripheral wall of the first receptacle receiver may include circumferentially spaced, longitudinal slots as described above or the spiral slot just described, while the peripheral wall of the second receptacle receiver 12 defines instead of the above-mentioned longitudinal slots, an inwardly extending projection adjacent to its outer edge and a slot 200 (See Fig. 16A) that includes a portion 202 that extends longitudinally toward the main body from its outer edge to one end 204 of a substantially circumferentially disposed slot 206 that extends approximately one-halfway around the circumference of the second receptacle receiver 12.
  • a second receptacle 58 defining a projection receiving portion adjacent to its sealed open end may be easily, yet securely, inserted into the second receptacle receiver 12 by virtue of the resilient movability of the outer circumferential portion 208 (see, Fig. 15A) of the peripheral wall of the second receptacle receiver located between the circumferentially extending slot 206 and the outer edge of the peripheral wall.
  • This construction facilitates the secure, yet removable, disposition of a second receptacle 58 in the second receptacle receiver 12 particularly in those cases in which it is important to load the second receptacle receiver quickly so as to avoid liquid loss from the first receptacle 56 and to maintain the reduced pressure in the second receptacle 58 for drawing the first substance into the second receptacle through the first passageway 72 through the main body 10.
  • Fig 2 shows the receptacle receivers as having a circular cross-section, however, in permissible alternative embodiments, the interiors of the receptacle receivers can have cross sectional shapes other than circular, including oval, square, rectangular or other closed shapes.
  • the operation of the present invention now will be discussed with reference to the preferred embodiments depicted in the drawings (which are similar in this regard as between Figs. 1A - 6B, 8A - 13B and 14A- 19B).
  • the first piercing cannula 50 is attached to the main body 10 in the manner generally shown in Figs. 2A - 3B.
  • the closure member 48 is used to tightly seal the side opening 42 of the main body 10 in the manner shown in Figs. 2 A - 3B.
  • the assemblage thus formed is interconnected with the first receptacle 56 in the manner shown in Figure 3.
  • the first receptacle receiver 14 receives the first receptacle 56 securely with the first locking member 26 engaging the upper portion 60 of the first receptacle 56.
  • This assemblage that at this stage comprises the first piercing cannula 50, the main body 10, the closure means 48, and the first receptacle 56, is mated with the second receptacle 58 in the manner generally shown in Figs. 4A -4B.
  • the substance in the second receptacle 58 as previously mentioned is under reduced pressure or vacuum.
  • the liquid substance in the first receptacle 56 will be automatically and rapidly drawn into the container portion 66 of the second receptacle 58 in the manner indicated in Figs. 4A — 5B.
  • particulates that may be contained in the liquid substance or generated otherwise will be prevented from entering into the container portion 66 of the second receptacle 58 by the first filter means 32 in the piercing cannula 50.
  • the first receptacle 56 along with the first piercing cannula 50 is disconnected from the main body 10 as generally indicated in Figs. 5 A and 5B.
  • the presence of sharp features 51 ensures that the first piercing cannula 50 disengages from the main body 10 as the first receptacle 56 is axially rotated as discussed above.
  • an aspirating means 76 is attached to the connecting portion 40 as discussed above.
  • the aspirating means 76 is a needleless syringe assembly that is threadably connected the main body 10.
  • the closure member 48 is removed from the opening 42 in the sidewall of the main body 10 so as to expose one end of the second passageway 47 which in turn is connected to the venting lumen 38 of the second piercing cannula 34 with filter means 46 attached.
  • the aspirator or syringe 76 then is used in a conventional manner to withdraw the mixture from the container while the venting lumen and second passageway equalize the pressure in the second receptacle with the outside environment in order to avoid the creation of air locks in the first passageway 72.
  • the aspirator 76 is disconnected from the assemblage by unscrewing its fitting from the connecting portion 40 as generally shown in Figure 6, and the mixture is delivered to patient or other desired destination via the aspirator 76.
  • the reconstitution and transfer device of the present invention solves numerous problems associated with conventional reconstitution and transfer devices. Specifically,
  • receptacles that contain a liquid substance or a solid substance can be securely connected with the apparatus of the present invention, thereby simplifying the mixing and transfer operation;

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention a trait à un appareil et un procédé pour le transfert d'une première substance depuis un premier réceptacle dans un deuxième réceptacle sous pression réduite, le mélange des substances et la distribution aseptique du mélange vers un dispositif de réception. L'appareil comporte un corps principal présentant des première et deuxième extrémités, un premier dispositif de réception de réceptacle à la première extrémité et un dispositif de réception de réceptacle à la deuxième extrémité. Un premier passage relie les première et deuxième extrémités et un deuxième passage relie la deuxième extrémité à une ouverture latérale. Un organe de fermeture engage de manière amovible l'ouverture latérale. Une canule perforante comprenant une pluralité de lumières s'étend depuis la deuxième extrémité pour relier l'intérieur du deuxième réceptacle aux premier et deuxième passages, et une autre canule perforante comprenant une lumière est reliée de manière amovible à la première extrémité et s'étend à partir de celle-ci pour relier l'intérieur du premier réceptacle au premier passage. Lorsque les premier et deuxième passages sont reliés à l'appareil, les canules s'étendent à travers des joints au niveau des extrémités ouvertes de ceux-ci pour permettre le prélèvement de la première substance vers l'autre réceptacle pour former le mélange. Le mélange est transféré vers un dispositif d'aspiration par le retrait de l'organe de fermeture pour égaliser la pression dans le deuxième réceptacle avec l'atmosphère environnante, le retrait de la première canule perforante conjointement avec le premier réceptacle du dispositif de réception du premier réceptacle, et le prélèvement du mélange hors du deuxième dispositif de réception à travers le premier passage avec le dispositif d'aspiration.
PCT/US2006/001080 2005-01-13 2006-01-12 Dispositif et procede de transfert et de reconstitution WO2006076492A2 (fr)

Applications Claiming Priority (2)

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US64354805P 2005-01-13 2005-01-13
US60/643,548 2005-01-13

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8268566B2 (en) 2006-04-07 2012-09-18 Hitachi Chemical Research Center, Inc. Enhanced FC receptor-mediated tumor necrosis factor superfamily MRNA expression in peripheral blood leukocytes in patients with rheumatoid arthritis
WO2014028745A2 (fr) * 2012-08-17 2014-02-20 Archon Pharmaceutical Consulting Llc Système de formulation et d'emballage prêt pour reconstituer des poudres de solutions de médicament en solution ou en suspension ou en injectable
US11028443B2 (en) 2015-08-31 2021-06-08 Showa Denko Materials Co., Ltd. Molecular methods for assessing urothelial disease

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3938520A (en) * 1974-06-10 1976-02-17 Abbott Laboratories Transfer unit having a dual channel transfer member
US5098407A (en) * 1989-01-09 1992-03-24 Terumo Kabushiki Kaisha Medical piercing cannula with drip chamber
US5636660A (en) * 1994-04-27 1997-06-10 Caremed Gmbh Device for transferring and drawing liquids
US20040249341A1 (en) * 2003-06-06 2004-12-09 Newbrough Jerry W. Reconstitution device and method of use

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3938520A (en) * 1974-06-10 1976-02-17 Abbott Laboratories Transfer unit having a dual channel transfer member
US5098407A (en) * 1989-01-09 1992-03-24 Terumo Kabushiki Kaisha Medical piercing cannula with drip chamber
US5636660A (en) * 1994-04-27 1997-06-10 Caremed Gmbh Device for transferring and drawing liquids
US20040249341A1 (en) * 2003-06-06 2004-12-09 Newbrough Jerry W. Reconstitution device and method of use

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8268566B2 (en) 2006-04-07 2012-09-18 Hitachi Chemical Research Center, Inc. Enhanced FC receptor-mediated tumor necrosis factor superfamily MRNA expression in peripheral blood leukocytes in patients with rheumatoid arthritis
WO2014028745A2 (fr) * 2012-08-17 2014-02-20 Archon Pharmaceutical Consulting Llc Système de formulation et d'emballage prêt pour reconstituer des poudres de solutions de médicament en solution ou en suspension ou en injectable
WO2014028745A3 (fr) * 2012-08-17 2014-04-10 Archon Pharmaceutical Consulting Llc Système de formulation et d'emballage prêt pour reconstituer des poudres de solutions de médicament en solution ou en suspension ou en injectable
US9688434B2 (en) 2012-08-17 2017-06-27 Archon Pharmaceutical Consulting Llc System for compounding and packaging ready to reconstitute ophthalmic drug powders to a solution or to a suspension for administration to an eye of patient
US10669063B2 (en) 2012-08-17 2020-06-02 Archon Pharmaceutical Consulting Llc System for compounding and packaging ready to reconstitute drug powders of solutions to a solution or to a suspension or to an injectable
US10703532B2 (en) 2012-08-17 2020-07-07 Archon Pharmaceutical Consulting Llc System for compounding and packaging ready to reconstitute ophthalmic drug powders to a solution or to a suspension for administration to an eye of a patient
US11028443B2 (en) 2015-08-31 2021-06-08 Showa Denko Materials Co., Ltd. Molecular methods for assessing urothelial disease

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