Incubation and/or stroage container system and method

Abstract

A container assembly ( 10 ) comprises a vessel ( 21 ) for containing a biological medium, gametes and/or one or more embryo(s). The vessel ( 21 ) has a CO 2 permeable seal ( 28 ) and a closure device ( 30 ) for selective access. A buffer chamber ( 60 ) for a CO 2 enriched atmosphere at least partially surrounds the vessel and is defined by a shell ( 61 ). The buffer chamber is in communication with the CO 2 permeable wall. Such a container assembly is particularly adapted for IVC in which case the permeable seal ( 28 ) prevents ingress of vaginal secretions. The buffer chamber ( 60 ) mediates the aqueous pH in the vessel after the container assembly is removed from a CO 2 enriched environment.

1 . A container assembly comprising (i) a vessel for containing a biological medium, gametes and/or one or more embryo (s), the vessel having a C0 2  permeable wall; (ii) a closure device for selective access to the interior of the vessel, and (iii) a buffer chamber for a C0 2  enriched atmosphere cooperable with the vessel and in communication with the C0 2  permeable wall.  
     
     
         2 . A container assembly according to  claim 1 , wherein the buffer chamber has an open condition for communication with a C0 2  enriched environment and a closed condition for closing off the chamber from the surroundings.  
     
     
         3 . A container assembly according to  claim 1 , further comprising a C0 2  permeable seal for impeding the ingress of liquids into the buffer chamber while allowing the entry of CO 2 .  
     
     
         4 . A container assembly according to  claim 1 , wherein the buffer chamber is defined by a shell disposed at least partly around the vessel.  
     
     
         5 . A container assembly according to  claim 4 , wherein the buffer chamber is defined by a shell disposed at least partly around the vessel and wherein said shell is mounted relative to the vessel for movement between an open position and a closed position corresponding to the respective open and closed conditions.  
     
     
         6 . A container assembly according to  claim 5 , further comprising a fluid tight seal operatively disposed between the vessel and the shell to prevent ingress and egress of fluids to and from the buffer chamber in the closed position.  
     
     
         7 . A container assembly according to  claim 1 , wherein the vessel comprises a main chamber and a microchamber for communication of the biological medium, gametes and/or one or more embryo (s) therebetween, the microchamber and at least part of the main chamber being surrounded by the buffer chamber and the C0 2  permeable wall including a wall defining the microchamber.  
     
     
         8 . A container assembly according to  claim 1 , wherein substantially the entire vessel wall is C0 2  permeable.  
     
     
         9 . A container assembly according to  claim 1 , wherein the buffer chamber has a lower C0 2  outflow rate than the C0 2  inflow rate of the vessel.  
     
     
         10 . A container assembly according to  claim 1 , wherein the buffer chamber ensures C0 2  equilibration after removal of the container assembly from a C0 2  enriched environment.  
     
     
         11 . A container assembly according to  claim 3 , for use in intravaginal fertilization and culture, wherein the C0 2  permeable seal is operatively disposed between the buffer chamber and the surroundings for impeding the ingress of vaginal fluids into the buffer chamber while allowing the entry of the C0 2  enriched gas.  
     
     
         12 . The container assembly according to  claim 3 , wherein the CO 2  permeable seal is readily replaceable with another seal having a different C0 2  permeable inflow rate.  
     
     
         13 . The container assembly according to  claim 1 , wherein the closure device comprises a valve including disc-shaped members in overlying relationship mounted for relative angular movement.  
     
     
         14 . The container assembly according to  claim 13 , wherein an inner one of the disc-shaped members is fixed relative to the vessel and an outer one of the disc-shaped members is mounted for angular movement.  
     
     
         15 . The container assembly according to  claim 14 , wherein each of the disc-shaped members has an orifice in a central panel for introducing a catheter or pipette for gametes and/or one or more embryo (s), an upstanding sidewall around the central panel and a peripheral flange extending radially outwardly from the sidewall.  
     
     
         16 . The container assembly according to  claim 1 , wherein the vessel comprises a main chamber and a microchamber for the flow of the biological medium and movement of gametes and/or embryos therebetween, the inner wall surface of the main chamber member tapering from an end fitted with the closure device, towards the microchamber.  
     
     
         17 . The container assembly according to  claim 16 , wherein an upper part of the vessel has an upwardly flaring sidewall and a peripheral flange extending outwardly therefrom, the sidewalls of the disc-shaped members being nested in the upwardly flaring sidewall of the vessel, and the peripheral flanges of disc-shaped members extending parallel to the peripheral flange of the vessel.  
     
     
         18 . The container assembly according to  claim 15 , wherein a liner of sealing material is affixed to the central panel of one of the disc-shaped members.  
     
     
         19 . The container assembly according to  claim 15 , wherein one of the disc-shaped members has a protruding lip along an edge defining an orifice therein, the lip facing the other of the disc-shaped members of the valve and sealingly engageable therewith.  
     
     
         20 . The container assembly according to  claim 19 , wherein said one of the disc-shaped members has a raised portion of substantially the same height of the protruding lip and spaced therefrom for maintaining the central panels parallel to each other.  
     
     
         21 . The container assembly according to  claim 15 , wherein the peripheral flange of upper one of the disc-shaped members has a peripheral sidewall radially outwardly beyond the peripheral flange of a lower one of the disc-shaped members and the peripheral flange of the lower disc-shaped member, the peripheral flange of the lower disc-shaped members having protrusions selectively cooperable with cutouts in the peripheral sidewall in a closed position of the closure device.  
     
     
         22 . The container assembly according to  claim 15 , wherein the peripheral sidewall of the upper disc-shaped member has one or more hooking members for snap-fitting axial retention of the upper disc-shaped member on the lower disc-shaped member.  
     
     
         23 . The container assembly according to  claim 5 , wherein an upper edge of the shell is in sealing engagement with a radially outwardly extending flange at an upper end of the vessel in the closed position of the buffer chamber.  
     
     
         24 . The container assembly according to  claim 5 , wherein said shell has an upstanding locating member on a bottom wall thereof and the vessel has a protruding complementary locating member at the lower end thereof.  
     
     
         25 . The container assembly according to  claim 24 , wherein the vessel in the open condition of the buffer chamber is angular offset from the vessel in the closed condition of the buffer chamber.  
     
     
         26 . The container assembly according to  claim 5 , wherein a locating member and complementary locating member define two locating positions corresponding respectively to the open and closed positions of the shell, a portion of a lower end part of the vessel being in engagement with the complementary locating member in a first locating position, a portion of the lower end part of the vessel extending beyond the upper part of the complementary locating member in the second locating position.  
     
     
         27 . The container assembly according to  claim 26 , wherein the locating member and complementary locating member have respective cooperable detent means for defining said first and second locating positions.  
     
     
         28 . The container according to  claim 1 , wherein the buffer chamber comprises a shell having a marking surface on an external wall for patient identification.  
     
     
         29 . The container assembly according to  claim 1 , wherein the vessel and closure device define an intravaginal container for intravaginal incubation, and further comprising a container sleeve with opposed rounded ends suitable for cooperation with a vaginal vault, the rounded ends having inner faces cooperable with opposed ends of the container, and an elastic sidewall connecting the rounded ends and urging the inner faces towards each other when the container is received in the sleeve.  
     
     
         30 . The intravaginal incubation container assembly according to  claim 29 , wherein the elastic sidewall has one or more openings for introduction and removal of the intravaginal container.  
     
     
         31 . The intravaginal incubation container assembly according to  claim 29 , wherein an inner face of one of the sleeve ends has a plug engageable in and mating with a central recess defined by the closure member for urging elements of a closure member towards each store.  
     
     
         32 . The container assembly according to  claim 7 , wherein the microchamber has opposed walls of suitable quality for viewing the contents of the microchamber under magnification, an abutment being provided on an inner surface of one or both of the opposed walls for docking a catheter, substantially at the middle of the opposed walls.  
     
     
         33 . The container assembly according to  claim 32 , wherein the abutment is a part of a recess in the one of the opposed walls of the microchamber.  
     
     
         34 . The container assembly according to  claim 33 , wherein a portion of the recess in the one of the opposed walls of the microchamber defines an interior lens face and the outer surface of the vessel proximate to a junction of the main chamber and the microchamber and in viewing alignment with the interior lens face comprising an exterior lens face, a lens thus defined by the lens faces being located for viewing one or more embryos in a catheter during or after retrieval from the microchamber.  
     
     
         35 . The container assembly according to  claim 32 , wherein a portion of the opposed walls of the microchamber and a portion of the main chamber proximate to a junction of the main chamber and the microchamber define an interior lens face in viewing alignment with an exterior lens face, the lens thus defined by the lens faces being located for viewing one or more embryos in the catheter during or after retrieval from the microchamber.  
     
     
         36 . The container assembly according to  claim 35 , wherein the zones adjoining internal walls and a floor of the microchamber include an inclined portion for opposing the formation of fluid vortexes.  
     
     
         37 . The container assembly according to  claim 7 , wherein, the inner wall surface of the main chamber is generally frustoconical and includes a small end section adjoining and merging into the microchamber, the microchamber being of generally rectangular cross section, the configuration of the inner wall surface of the main chamber favoring the flow of biological medium therebetween.  
     
     
         38 . The container assembly according to  claim 1 , wherein said buffer chamber mitigates temperature changes inside the vessel when the container assembly is removed from a C0 2  enriched environment at a temperature of about 37° C.  
     
     
         39 . The container assembly according to  claim 6 , wherein the fluidtight seal operatively disposed between the vessel and the shell in a closed position of the shell is adapted to prevent inflow of the atmosphere of 
 the surroundings after removal from a temperature controlled C0 2  enriched environment and/or outflow of C0 2  enriched atmosphere from the buffer chamber.    
     
     
         40 . The container assembly according to  claim 6 , wherein the fluidtight seal operatively disposed between the vessel and the shell in a closed position of the shell is adapted to prevent inflow of 0 2  into the buffer chamber after removal from a temperature controlled 0 2  depleted atmosphere.  
     
     
         41 . The container assembly according to  claim 4 , wherein the shell defining the buffer chamber impedes the loss of gas therefrom, and the shell has a much lower C0 2  outflow than the C0 2  inflow rate of the vessel wall.  
     
     
         42 . The container assembly according to  claim 1 , wherein the CO 2  permeable seal has a C0 2  permeability at least an order of magnitude greater than that of the vessel wall.  
     
     
         43 . The container assembly according to  claim 1 , wherein the C0 2  permeable seal has a C0 2  permeability at least two orders of magnitude greater than that of the shell.  
     
     
         44 . The container assembly according to  claim 7 , wherein the volume of the main chamber is between about 10 and about 100 ml, and the volume of the microchamber is between about 0.4 and about 1.5 ml.  
     
     
         45 . The container assembly according to  claim 21 , wherein the at least radial protrusion is adapted to audibly clear an edge of at least one of the cutouts, as the closure device reaches the closed position.  
     
     
         46 . The container assembly according to  claim 1 , wherein the buffer chamber is defined by a shell surrounding the vessel.  
     
     
         47 . The container assembly according to  claim 46 , wherein said shell has at least two parts, the shell parts having coupling means for coupling the shell parts in the closed position.  
     
     
         48 . The container assembly according to  claim 47 , wherein a gas flow passage is defined between respective ones of said at least two shell parts.  
     
     
         49 . The container assembly according to  claim 48 , wherein a C0 2  permeable seal is located in the gas flow passage for allowing the flow of C0 2  enriched air from a source of C0 2  enriched air into the buffer chamber.  
     
     
         50 . The container assembly according to  claim 49 , wherein said C0 2  permeable seal is adapted to prevent the ingress of vaginal fluids into the buffer chamber.  
     
     
         51 . The container assembly according to  claim 47 , wherein the CO 2  permeable seal is compressed between respective shell parts in the closed position.  
     
     
         52 . The container assembly according to  claim 46 , wherein the shell has rounded ends and is sized and configured for residence in the posterior fornix.  
     
     
         53 . The container assembly according to  claim 46 , wherein the shell is made of rigid and transparent biocompatible material.  
     
     
         54 . The container assembly according to  claim 46 , wherein the shell has a transverse dimension of about 20 mm to about 25 mm and a longitudinal dimension of about 40 mm to about 50 mm.  
     
     
         55 . The container assembly according to  claim 47 , wherein said coupling means holds the respective shell parts against angular and longitudinal movement in the closed position of the shell.  
     
     
         56 . The container assembly according to  claim 55 , wherein said coupling means comprises a groove in one of said respective shell parts having a first longitudinal portion followed by a circumferential portion, and the other one of the respective shell parts having a boss shaped for restrained movement in the groove.  
     
     
         57 . The container assembly according to  claim 56 , wherein the circumferential portion has an endwall cooperable with the boss for defining the closed position of the shell and a bump located in the circumferential portion spaced from the endwall to limit inadvertent relative angular movement of the shell parts from the closed position.  
     
     
         58 . The container assembly according to  claim 47 , wherein at least one of the shell parts has a label groove along the inside wall of said at least one shell part.  
     
     
         59 . The container assembly according to  claim 58 , wherein the label groove protrudes inwardly from the inner sidewall of the at least one part of the shell for cooperating with the vessel or an appurtenance thereon for axially aligning the vessel relative to the shell.  
     
     
         60 . The container assembly for storage or shipment of gametes and/or at least one embryo according to  claim 1.