Sealing apparatus for cryopreservation bag

There is provided a sealing apparatus for a cryopreservation bag, with which a sealing treatment of an inlet/outlet of the cryopreservation bag is carried out automatically and anyone can safely and properly carry out the sealing treatment.The sealing apparatus includes: a bag clamping device 56; a laser device 57; and a scanning structure 58 for moving the bag clamping device 56, for example. The bag clamping device 56 includes a fixed pinching block 67, a movable pinching block 69, and a clamp actuator 70. The laser device 57 includes a laser oscillator 104 and a condensing lens 107. The fixed pinching block 67 includes a block base 73, a heat radiator 74, and a heat radiator holder 75. An infrared laser beam is radiated to a sealed portion 55 of the bag to form a seal bead 125 for sealing in a state in which the sealed portion 55 is pinched and fixed by the heat radiator 74 and the movable pinching block 69 and while the bag clamping device 56, for example, is moved by the scanning structure 58.

TECHNICAL FIELD

The present invention relates to a sealing apparatus for sealing and hermetically closing an opening portion of a cryopreservation bag used in cryopreserving human, animal, or plant biological tissue. The cryopreservation bag is formed as a bag-shaped container by welding two layered fluorine-based resin sheets by use of an infrared laser beam.

BACKGROUND ART

This type of cryopreservation bag is disclosed in Patent Literature 1, for example. Here, the bag-shaped cryopreservation bag is formed by sandwiching and pressurizing two layered thermoplastic resin films between a supporter and an infrared transmitting solid heat radiating member (hereinafter merely referred to as “heat radiating member”) and radiating an infrared laser beam on both the films from a side of the heat radiating member to form a weld bead.

Regarding the sealing apparatus according to the invention, sealing of an opening portion of a cryopreservation container by thermal welding is disclosed in Patent Literature 2. Here, a plastic container main body for housing a biological sample is integrally provided with an opening portion and a tear portion and the opening portion is sealed by thermal welding with a sealer after the biological sample is housed into the container main body.

PRIOR ART DOCUMENTS

Patent Documents

SUMMARY OF THE INVENTION

Problems to be Solved by the Invention

Because the cryopreservation bag in Patent Literature 2 is made of polyethylene terephthalate, for example, the bag can be satisfactorily sealed by use of a commercially available impulse sealer. However, a cryopreservation bag made of fluorine-based resin need be sealed at a higher temperature and therefore it is difficult for the commercially available sealer to uniformly impart a high-level sealing function to every bag by thermally welding an inlet/outlet. Liquid nitrogen may enter the cryopreservation bag which cannot perform the high-level sealing function. If this cryopreservation bag is taken out of a container for liquid nitrogen while the entry is not known, the liquid nitrogen may suddenly expand to break the cryopreservation bag and scatter contents. The cryopreservation bag is often used in clinical settings such as a hospital and doctors and medical technologists who are main users are expected to safely and properly seal the cryopreservation bag and obtain the high-level of sealing function of the bag.

It is an object of the present invention to provide a sealing apparatus for a cryopreservation bag, with which a sealing treatment of the cryopreservation bag can be carried out easily, automatically, safely, and properly.

Solution to Problems

A sealing apparatus for a cryopreservation bag according to a first aspect of the present invention includes: a bag clamping device56for pinching and fixing a sealed portion55of the cryopreservation bag; a laser device57for radiating an infrared laser beam toward the sealed portion55pinched and fixed by the bag clamping device56; a scanning structure58for moving any one of the bag clamping device56and the laser device57; and a frame59for supporting the respective members56to58. The bag clamping device56includes a fixed pinching block67supported by a scanning base65fixed to the frame59, a movable pinching block69supported by a guide shaft68provided to the fixed pinching block67to be able to come in contact with and move away from the fixed pinching block67, and a clamp actuator70for bringing the movable pinching block69into contact with and moving the movable pinching block69away from the fixed pinching block67. The laser device57includes a laser oscillator104and a condensing lens107for condensing the infrared laser beam radiated from the laser oscillator104toward the sealed portion55of the cryopreservation bag. The fixed pinching block67includes a block base73in which a radiation window72for the infrared laser beam is open, a heat radiator74made of solid material with high infrared transmissivity and high heat conductivity, and a heat radiator holder75mounted to the block base73to support the heat radiator74so that the heat radiator74faces the radiation window72. The infrared laser beam is radiated to the sealed portion55of the cryopreservation bag to form a seal bead125crossing an inlet/outlet3at the sealed portion55in a state in which the sealed portion55is pinched and fixed by the heat radiator74, the heat radiator holder75, and the movable pinching block69and while any one of the bag clamping device56and the laser device57is moved by the scanning structure58.

The scanning structure58includes a guide body89provided to the scanning base65, a slide body90guided and supported by the guide body89to be able to slide leftward and rightward, a clamping table91fixed to the slide body90, and a scanning actuator93provided to the scanning base65to reciprocate the clamping table91leftward and rightward. The block base73of the fixed pinching block67is supported by the clamping table91. The infrared laser beam is radiated from the radiation window72to the sealed portion55to form the seal bead125crossing the inlet/outlet3at the sealed portion55while the bag clamping device56is moved by the scanning structure58.

The scanning base65is fixed to an upper frame60forming the frame59. A scanning window66for allowing leftward and rightward movements of the bag clamping device56is open in the scanning base65and the movable pinching block69and the fixed pinching block67face an outer face of the scanning window66. The sealed portion55of the cryopreservation bag can be attached to and detached from the bag clamping device56on the outer face of the scanning window66.

The movable pinching block69is supported by paired left and right sliders79supported by the guide shaft68to be able to slide forward and backward in a reciprocating manner, a plate-shaped movable base80fixed to and supported by both the sliders79, and paired left and right block support shafts81fixed to left and right positions of a front face of the movable base80. The clamp actuator70for moving the movable pinching block69forward and backward via the movable base80and the block support shafts81is provided to an inner base84fixed to the guide shaft68. The sealed portion55of the cryopreservation bag is clamp-fixed by both the fixed and movable pinching blocks67and69by operating the movable pinching block69with the clamp actuator70in a state in which the sealed portion55is brought in contact with an outer face of the heat radiator74of the fixed pinching block67.

The movable pinching block69is detachably mounted to a block support shaft81by a first mounting member83. The heat radiator holder75is detachably mounted to the block base73by a second mounting member77. The movable pinching block69and the heat radiator holder75can be detached from the block support shaft81and the block base73and sterilized.

A focus adjustment structure for adjusting a focus position of the condensing lens107is provided inside the frame59. The focus adjustment structure includes a lens base108supported by an inner frame92fixed to the scanning base65, a lens guide109fixed to the lens base108, a forward-backward slider110supported by the lens guide109to be able to slide forward and backward, a lens holder111fixed to the forward-backward slider110to support the condensing lens107, and a focus adjustment actuator112for operating the lens holder111forward and backward. The focus position of the condensing lens107is adjusted according to a thickness of the sealed portion55pinched and fixed by the bag clamping device56.

A vertical scanning structure for adjusting a vertical position of the bag clamping device56is provided inside the frame59. The vertical adjustment structure includes a vertical guide97fixed to the clamping table91, a vertical slider98fixed to the block base73and supported by the vertical guide97to be able to slide vertically, an actuator base100fixed to the clamping table91, and a vertical scanning actuator99disposed between the base100and the inner base84to operate the bag clamping device56vertically. A position of the sealed portion55where the seal bead125is formed can be changed by vertically operating the bag clamping device56with the vertical scanning structure.

A moving stroke of the bag clamping device56by the scanning structure58is set to be larger than a left-right width of the sealed portion55of the cryopreservation bag and the seal bead125can be formed across the sealed portion55of the cryopreservation bag from one end to the other end.

An outer face of the frame59is covered with a protective barrier117for preventing exposure to infrared laser leaking from the laser device57. A protective cover118for preventing exposure to the infrared laser is provided to an outer face of the bag clamping device56to be able to open and close.

Advantageous Effects of Invention

The sealing apparatus for the cryopreservation bag according to the first aspect of the invention is formed by the bag clamping device56, the laser device57, the scanning structure58, and the like. The bag clamping device56is formed by the fixed pinching block67, the movable pinching block69, the clamp actuator70for bringing the fixed pinching block67and the movable pinching block69into contact with each other and moving them away from each other, and the like so that the sealed portion55of the cryopreservation bag can be pinched and fixed by both the pinching blocks67and69by actuating the actuator70. Furthermore, the fixed pinching block67is formed by the block base73, the heat radiator74, the heat radiator holder75, and the like so that the infrared laser beam throttled by the condensing lens107can be radiated to the sealed portion55through the heat radiator74to form the seal bead125while any one of the bag clamping device56and the laser device57is moved by the scanning structure58.

With the above-described sealing apparatus, the inlet/outlet3of the cryopreservation bag formed by fluorine-based resin sheets S1and S2can be sealed easily and automatically by moving the movable pinching block69by the clamp actuator70to clamp the sealed portion55and then actuating the scanning structure58and the laser device57. The sealing operation of the sealed portion55of the cryopreservation bag is carried out by doctors or medical technologists. Because a series of welding operations is carried out automatically after the sealed portion55is clamped by the bag clamping device56, it is possible to safely and properly carry out the sealing treatment of the cryopreservation bag. Moreover, the sealing treatment is always carried out automatically under constant conditions and therefore there is no variation between welding results. As a result, it is possible to provide the sealing apparatus for the cryopreservation bag, with which anyone can easily carry out the sealing treatment which can stably impart the high sealing function. Especially, the sealing treatment can be carried out properly even for the cryopreservation bag made of fluorine-based resin which need be sealed at a high temperature.

If the scanning window66for allowing the leftward and rightward movements of the bag clamping device56is open in the scanning base65and the movable pinching block69and the fixed pinching block67face the outer face of the scanning window66, it is possible to easily attach and detach the sealed portion55to and from the bag clamping device56on the outer face of the scanning window66. Therefore, it is possible to appropriately clamp the sealed portion55with the bag clamping device56while checking a position and an attitude of the cryopreservation bag or it is possible to reliably retrieve the cryopreservation bag after the welding operation is finished, which improves usability of the sealing apparatus.

If the movable pinching block69is supported by the paired sliders79, the movable base80, and the paired block support shafts81fixed to the movable base80to be able to slide forward and backward with respect to the guide shaft68of the fixed pinching block67, the movable pinching block69can be smoothly moved forward and backward with respect to the fixed pinching block67and parallelism between pinching faces of both the pinching blocks67and69can be enhanced. Moreover, if the clamp actuator70is provided to the inner base84fixed to the guide shaft68, the movable pinching block69can be operated forward and backward by the clamp actuator70with the simpler structure and the sealed portion55can be reliably clamp-fixed between both the fixed and movable pinching blocks67and69.

The movable pinching block69is detachably mounted to the block support shaft81by the first mounting member83. The heat radiator holder75is detachably mounted to the block base73by the second mounting member77. With this sealing apparatus, the movable pinching block69and the heat radiator holder75can be detached from the block support shaft81and the block base73as necessary and the movable pinching block69and the heat radiator holder75to which the biological tissue may be attached can be sterilized. Therefore, it is possible to facilitate hygiene control of the movable pinching block69, the heat radiator74, and the heat radiator holder75to carry out the sealing treatment of the sealed portion55of the cryopreservation bag in a hygienically safe condition.

If the focus adjustment structure for adjusting the focus position of the condensing lens107is provided, the focus position of the condensing lens107can be easily adjusted by only actuating the focus adjustment actuator112. Therefore, the sealed portion55can be welded under optimum welding conditions by adjusting the focus position of the condensing lens107according to differences in material and thickness of the fluorine-based resin sheets S1and S2forming the cryopreservation bag.

If the vertical scanning structure for adjusting the vertical position of the bag clamping device56is provided, a position of the sealed portion55to be welded can be changed easily in a vertical direction by actuating the vertical scanning actuator99. Moreover, by actuating the vertical scanning actuator99in synchronization with a feeding operation of the scanning structure58, it is possible to diversify patterns in which the seal bead125is formed, e.g., multiple seal beads125may be formed or the seal bead125may be formed in a continuous wave pattern.

If the moving stroke of the bag clamping device56by the scanning structure58is set to be larger than the lateral width of the sealed portion55of the cryopreservation bag, the seal bead125can be formed continuously from one end to the other end of the sealed portion55. Therefore, it is possible to obtain the cryopreservation bag in which the sealed portion55is more reliably sealed with the continuous seal bead125and which has sufficient durability to withstand severe cryopreservation.

If the outer face of the frame59is covered with the protective barrier117and the protective cover118which can open and close is provided to the outer face of the bag clamping device56, it is possible to prevent a user from being exposed to the infrared laser leaking from the laser device57in welding of the sealed portion55and therefore the sealing treatment of the sealed portion55can be carried out further safely.

DESCRIPTION OF EMBODIMENTS

FIGS. 1 to 14show embodiments of a sealing apparatus and related devices for a cryopreservation bag according to the invention. Front, back, left, right, up, and down in the invention are shown by four-direction arrows shown inFIGS. 2 and 3and words, front, back, left, right, up, and down written near the respective arrows. The sealing apparatus according to the invention seals the cryopreservation bag having a structure shown inFIG. 8, for example. Before describing the sealing apparatus, the structure of the cryopreservation bag and a manufacturing device of the bag will be described briefly.

InFIG. 8, the cryopreservation bag is obtained by forming a traversable outline bead1at an interface between two layered fluorine-based resin sheets S1and S2by radiating an infrared laser beam on the sheets S1and S2to form a housing portion2in which biological tissue is to be housed and an inlet/outlet3continuous with the housing portion2in an area between both the sheets S1and S2and surrounded with the outline bead1. The outline bead1defining the housing portion2is formed by paired parallel upper bead portion4and lower bead portion5, paired parallel left bead portion6and right bead portion7, and four corner bead portions8formed at corner portions adjacent to the respective bead portions4to7. In this way, the housing portion2is formed into a vertically-long rectangular shape with four rounded corners. The inlet/outlet3is formed at a center in a left-right direction of the upper bead portion4. By providing the corner bead portions8, right-angled inner corners are not formed in the housing portion2and the biological tissue housed in the housing portion2can be taken out until nothing is left.

The fluorine-based resin sheets S1and S2are formed as infrared laser transmitting transparent sheets made of any one of perfluorinated resin, partially fluorinated resin, and fluorinated resin copolymer. Specifically, the materials may be polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF), polyvinyl fluoride (PVF), perfluoroalkoxy fluorine-based resin (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), ethylene-tetrafluoroethylene copolymer (ETFE), chlorotrifluoroethylene copolymer (ECTFE), and the like. In the embodiment, the fluorine-based resin sheets S1and S2are formed by the sheets made of tetrafluoroethylene-hexafluoropropylene copolymer and having thicknesses of 100 μm and both the sheets S1and S2are irradiated with the infrared laser beam to form the cryopreservation bag.

InFIG. 11, the manufacturing device for the cryopreservation bag is formed by a sheet fixing structure15on a base14, a laser device16for radiating the infrared laser beam toward the two layered fluorine-based resin sheets S1and S2supported by the sheet fixing structure15, a scanning structure17for moving the sheet fixing structure15with respect to the infrared laser beam, and the like.

The sheet fixing structure15is formed by a sheet table18for supporting the two layered fluorine-based resin sheets S1and S2and a sheet pressing body19for pressing and retaining the fluorine-based resin sheets S1and S2placed on the sheet table18. The sheet table18includes an aluminum table main body20having high heat conductivity and a table base21for fixing and supporting the table main body20and a bracket22to which hinges29(described later) are mounted on left and right sides of a back end of the table base21is formed to protrude upward (seeFIG. 10). An upper face (placing face) of the table main body20on which the fluorine-based resin sheets S1and S2are placed is formed as a flush horizontal face.

The sheet pressing body19includes a heat radiator25made of solid material having high infrared transmissivity and heat conductivity and a steel pressing frame26for supporting the heat radiator25. The heat radiator25is formed by a single-crystal silicon disc transparent to the infrared laser. As shown inFIG. 12, the pressing frame26is formed by an octagon-shaped metal frame body, a circular laser window27is open at a center of the pressing frame26, and a circular mounting seat28is formed on a lower face side of the window27. The heat radiator25is fitted and fixed into the mounting seat28.

By connecting a back portion of the pressing frame26and the bracket22of the table base21with the paired left and right hinges29, the entire sheet pressing body19is supported on the sheet table18to be able to swing open and close in a vertical direction. The sheet pressing body19can be displaced between a welding attitude shown inFIGS. 12 and 13and a standby attitude shown inFIG. 10when a handle30is gripped and opened/closed. A stopper32fixed to the bracket22receives a rubber block31provided at a center of the back portion of the sheet pressing body19so as to retain the sheet pressing body19, which has been opened into the standby attitude, in a backward inclined attitude. In this state, the two layered fluorine-based resin sheets S1and S2are placed on the table main body20or a blank body of the cryopreservation bag after the welding treatment can be taken out of the table main body20.

The laser device16is a commercially available carbon dioxide laser unit, a radiating pipe34protrudes from a side end of a rectangular box-shaped case which is long in a left-right direction, and a laser beam output from a resonator in the case is deflected downward by a deflecting mirror35and then throttled by a condensing lens36provided in a laser head and radiated from a laser nozzle37. The laser device16is supported by a laser base38fixed onto the base14and a height adjustment structure39provided to the laser base38. The height adjustment structure39is formed by assembling a plurality of pairs of linkages in X shapes and a vertical height of the laser device16can be adjusted by increasing and decreasing angles of intersection of the X-shaped pairs of linkages by turning an adjustment threaded shaft40disposed at a center in a vertical direction of the linkage pairs.

The scanning structure17is formed as an X-Y stage by a Y-axis slider43fixed onto the base14and an X-axis slider44fixed to a moving table45of the Y-axis slider43. The Y-axis slider43and the X-axis slider44are respectively formed by commercially available ball screw type electric sliders and disposed to be orthogonal to each other. The table base21of the sheet table18is fixed to a moving table46of the X-axis slider44. By supporting the table base21on the X-Y stage provided to the base14, it is possible to freely displace the table main body20with respect to the laser nozzle37. In this way, by radiating the infrared laser beam on the fluorine-based resin sheets S1and S2while moving the moving tables45and46of the Y-axis slider43and the X-axis slider44according to preset X-Y coordinates, it is possible to form a weld bead in an arbitrary shape in the interface between both the sheets S1and S2. InFIG. 11, reference sign47designates a controller for controlling actuated states of the laser device16and the scanning structure17.

The cryopreservation bag is manufactured by the following manufacturing procedure. The laser device16carries out focus adjustment of its condensing lens36in advance so that the infrared laser beam is focused on the interface between the two layered fluorine-based resin sheets S1and S2. After the sheet pressing body19is opened into the standby attitude as shown inFIG. 10, the fluorine-based resin sheets S1and S2are placed and positioned at a center of the table main body20and the sheet pressing body19is swung down into the welding attitude. Then, as shown inFIG. 13, the scanning structure17is actuated to align a welding start position with a radiation position of the infrared laser beam and the traversable outline bead1is formed in the interface between the fluorine-based resin sheets S1and S2while the laser device16and the scanning structure17are actuated synchronously.

InFIGS. 1 to 9, the sealing apparatus for the cryopreservation bag is formed by a bag clamping device56for pinching and fixing a sealed portion55(seeFIG. 9) of the cryopreservation bag, a laser device57for radiating the infrared laser beam toward the sealed portion55pinched and fixed by the bag clamping device56, a scanning structure58for moving the bag clamping device56, a frame59for supporting the respective members56to58, and the like. The frame59includes an upper frame60to which the bag clamping device56, the scanning structure58, and the like are mounted and a lower frame61for supporting the upper frame60and the laser device57and a controller62are disposed inside the lower frame61. A scanning base65in a laterally-long plate shape is fixed to an inner face of a backward-inclining front portion of the upper frame60and a scanning window66for allowing leftward and rightward movements of the bag clamping device56is open at the center in a vertical direction of the scanning base65.

As described already, after the biological tissue is filled into the housing portion2of the cryopreservation bag and the bag is evacuated, seal beads125(described later) are formed at the sealed portion55to be orthogonal to the inlet/outlet3. As shown inFIG. 9, the sealed portion55is a sheet area between the upper bead portion4and an upper end of the inlet/outlet3and the seal beads125are preferably formed to be orthogonal to or to intersect the inlet/outlet3at the center in the vertical direction of the sealed portion55.

InFIGS. 1, 4, and 5, the bag clamping device56is formed by a fixed pinching block67supported by the scanning base65, a movable pinching block69supported by paired guide shafts68fixed to a back face of the fixed pinching block67to be able to come in contact with and move away from the fixed pinching block67, a solenoid (clamp actuator)70(seeFIG. 1) for bringing the movable pinching block69in contact with and moving the movable pinching block69away from the fixed pinching block67, compression coil springs71for moving and biasing the movable pinching block69forward, and the like. The fixed pinching block67includes a block base73which is long in the left-right direction and in which a radiation window72for the infrared laser beam is open, a heat radiator74made of solid material having high infrared transmissivity and heat conductivity and a heat radiator holder75mounted to the block base73to support the heat radiator74so that the heat radiator74faces the radiation window72.

The block base73of the fixed pinching block67is supported by a clamping table91and a vertical adjustment structure and this will be described later in detail. The heat radiator74is made of solid material having high infrared transmissivity and heat conductivity. As the solid material forming the heat radiator74, any one of zinc selenide, zinc sulfide, and silicon, which are transparent to the infrared laser, can be used, because the welding treatment is carried out by use of the carbon dioxide laser. In the embodiment, the heat radiator74is formed in a laterally-long plate shape by using single-crystal silicon. The heat radiator74is mounted and fixed to the heat radiator holder75so as to close a front face of a radiation slit76open at a center in the vertical direction of the heat radiator holder75made of steel. Front faces of the heat radiator74and the heat radiator holder75are flush with each other. Left and right opposite ends of the heat radiator holder75are detachably mounted by second screw bodies (second mounting members)77screwed into the block base73(seeFIG. 4). The second screw bodies77are hand screws, each formed by fixing an operating knob to an end portion of a threaded shaft, and it is possible to mount and detach the heat radiator holder75by turning the operating knob with fingertips.

The movable pinching block69is formed by an aluminum plate material having high heat conductivity and supported by paired left and right sliders79supported by the above-described guide shafts68to be able to slide in reciprocating manners, a plate-shaped movable base80fixed to and supported by both the sliders79, and paired left and right block support shafts81fixed to left and right positions of a front face of the movable base80as shown inFIG. 1. The block support shafts81protrude forward from shaft insertion holes82(seeFIG. 4) formed in the block base73and the movable pinching block69is detachably mounted to front ends of the block support shafts81by first screw bodies (first mounting members)83. The first screw bodies83are hand screws similar to the second screw bodies77. In order to make attachment and detachment of the sealed portion55by the bag clamping device56easy and reliable, the movable pinching block69and the fixed pinching block67respectively face an outer face of the scanning window66.

As described above, the movable pinching block69is operated forward and backward by the solenoid70and the springs71to be displaced between a clamping attitude in which the movable pinching block69comes in contact with the heat radiator holder75from outside and a standby attitude in which the movable pinching block69moves forward away from the heat radiator holder75. In a normal state, the movable pinching block69receives biasing forces of the springs71and is kept in the standby attitude. As shown inFIG. 1, the solenoid70is mounted to an inner base84fixed to back ends of the guide shafts68and an operating shaft85continuous from a moving core of the solenoid70is fixed to a center in the left-right direction of the movable base80. As shown inFIGS. 2 and 3, a foot switch (switch)86for actuating the solenoid70is provided on a floor face in front of the sealing apparatus. If the switch86is stepped on, the moving core is attracted to an inside of the solenoid70and, in this way, it is possible to switch the movable pinching block69into the clamping attitude against the biasing forces of the springs71. This clamping attitude is maintained until the sealing treatment is finished. If the foot switch86is stepped on after the sealing treatment is finished, the movable pinching block69is returned into the standby attitude by the springs71.

As described above, if the movable pinching block69is supported to be able to slide forward and backward with respect to the guide shafts68of the fixed pinching block67, the movable pinching block69can smoothly move forward and backward with respect to the fixed pinching block67and it is possible to obtain high parallelism between pinching faces of both the pinching blocks67and69. Moreover, if the solenoid70is provided to the inner base84fixed to the guide shafts68, the movable pinching block69can be operated forward and backward by the solenoid70with a simpler structure and the sealed portion55can be reliably clamp-fixed between both the fixed and movable pinching blocks67and69.

The scanning structure58is formed by the scanning base65, guide rails (guide bodies)89provided to upper and lower positions of a front edge of the scanning window66of the scanning base65, four slide bodies90in total guided and supported by the guide rails89to be able to slide leftward and rightward, the laterally-long rectangular frame clamping table91fixed to the slide bodies90, a gate-shaped inner frame92fixed to a back face of a lower portion of the scanning base65, an electric slider (scanning actuator)93which is long in the left-right direction and fixed to the inner frame92, and the like. The clamping table91is formed in a laterally-long rectangular frame shape and the table91and a moving table94of the electric slider93are connected by an interlocking arm95in an inverted L shape. By actuating the electric slider93, the bag clamping device56can be moved while scanning from one end of the scanning window66to the other end. At this time, a moving stroke of the bag clamping device56by the scanning structure58is set to be sufficiently longer than a left-right width of the sealed portion55of the cryopreservation bag. A touch-screen display96is provided at a right upper corner of a front face of the frame59and it is possible to actuate the electric slider93to simultaneously cause the laser device57to radiate the infrared laser beam by touching a start button displayed on the display96.

In order to cause the bag clamping device56to scan upward and downward, a vertical scanning structure is provided inside the frame59. The vertical scanning structure is formed by a vertically-long guide rail (vertical guide)97fixed to the clamping table91, vertical sliders98supported by the guide rail97to be able to slide in reciprocating manners, a servomotor (vertical scanning actuator)99for operating the bag clamping device56upward and downward via the above-described inner base84, and the like. As shown inFIG. 4, the block base73of the fixed pinching block67is fixed to the paired left and right vertical sliders98. The servomotor99is disposed on an upper face of an actuator base100fixed to an inner face of an upper portion of the clamping table91and rotation power of the servomotor99is converted into reciprocating motion by a threaded shaft101and an internal thread body102fixed to the inner base84to move the bag clamping device56upward and downward.

InFIG. 2, the laser device57is a commercially available carbon dioxide laser unit and formed by a vertically-long rectangular box-shaped laser oscillator104, a radiating pipe105protruding from an upper end of the laser oscillator104, a deflecting mirror106for deflecting the laser beam output from the laser oscillator104into a diagonally upward direction, a condensing lens107for throttling the laser beam and radiating the laser beam toward the heat radiator74, and the like. In order to adjust a focus position of the condensing lens107, a focus adjustment structure is provided behind the inner frame92.

The focus adjustment structure is formed by a lens base108supported by the inner frame92, paired left and right lens guides109fixed to the lens base108, a forward-backward slider110supported to be able to slide forward and backward in a reciprocating manner by the respective lens guides109, a lens holder111fixed to the forward-backward slider110and supporting the condensing lens107, a servomotor (focus adjustment actuator)112for operating the lens holder111forward and backward, and the like. The servomotor112is disposed on a lower face side of the lens base108and rotation power of the servomotor112is converted into reciprocating motion by a threaded shaft113and an internal thread body114fixed to the lens holder111to adjust the focus position of the condensing lens107.

In the process of sealing the cryopreservation bag, the infrared laser emitted from the laser device57may leak and all peripheral side faces and an upper face of the frame59are covered with protective barriers117in order to avoid exposure to the leaking laser light. Moreover, in order to prevent leakage of the infrared laser radiated toward the sealed portion55, a protective cover118is provided to a front face of the bag clamping device56and supported to be swung open and close by a bracket119and hinges120provided to the frame59(seeFIGS. 1 and 2). In attaching and detaching the cryopreservation bag to and from the bag clamping device56, the protective cover118can be swung open upward and retained in an open position as shown inFIG. 2. InFIGS. 1 and 2, reference numeral121designates a drop prevention plate for preventing a drop of the cryopreservation bag after the sealing treatment onto a floor face by mistake.

A sealing procedure for the cryopreservation bag will be described below. Prior to the sealing treatment, preparation for radiation of the infrared laser is made by carrying out adjustment of the laser device57and the focus adjustment of the condensing lens107and the bag clamping device56is moved to a home position shown inFIG. 3. Moreover, the bag clamping device56is brought into a standby state by setting welding conditions while checking display on the display96. The biological tissue is filled into the housing portion2of the cryopreservation bag and the bag is evacuated so that the sealed portion55is flattened into a sheet shape. In this state, as shown inFIG. 6, the sealed portion55is inserted between the movable pinching block69and the heat radiator74and positioned. In this state, the foot switch86is stepped on and the solenoid70operates the movable pinching block69backward to bring the movable pinching block69into the clamping attitude.

In the state in which the movable pinching block69is brought into the clamping attitude, as shown inFIGS. 7 and 8, a most portion of the sealed portion55of the cryopreservation bag is pinched and fixed between the movable pinching block69and the heat radiator74. In this state, if the start button displayed on the display96is touched, the infrared laser beam is radiated from the laser device57toward the heat radiator74. Simultaneously, the electric slider93is actuated to feed the bag clamping device56from the home position toward a left side inFIG. 3at a constant speed to thereby form the seal bead125.

At this time, because the infrared laser passes through the heat radiator74, the heat radiator74does not absorb the infrared laser to generate heat. Moreover, although welding heat is conducted to a periphery of a position where the bead is formed when the seal bead125is formed, the welding heat which has reached to a back surface of the sealed portion55is absorbed by the heat radiator74with high heat conductivity and diffused. Similarly, the welding heat which has reached a front surface of the sealed portion55is absorbed by the movable pinching block69with high heat conductivity and diffused. Therefore, at the sealed portion55, only the interface between the fluorine-based resin sheets S1and S2is welded as shown in an enlarged view inFIG. 7.

When the seal bead125is formed from one end of the sealed portion55to the other end, the radiation of the infrared laser and the feeding operation by the scanning structure58are stopped temporarily. In this state, the servomotor99of the vertical scanning structure is actuated to move the bag clamping device56upward (or downward) a distance corresponding to a spot diameter of the infrared laser beam. Moreover, while the scanning structure58is actuated to feed the bag clamping device56toward a right side inFIG. 3, the infrared laser beam is radiated to the sealed portion55to form the return seal bead125below (or above) the outgoing seal bead125. When the bag clamping device56returns to the home position, as shown inFIG. 9, the two seal beads125extending across the sealed portion55in the outgoing and returning manners are formed. Then, if the foot switch86is stepped on while the cryopreservation bag is supported with a hand, clamping of the sealed portion55by the bag clamping device56is released and the cryopreservation bag can be taken out. The vertical scanning structure may be returned into an initial state when the bag clamping device56returns to the home position or the bag clamping device56may be moved in a reverse direction from the previous direction after the return seal bead125is formed. By repeating the above-described procedure, it is possible to properly form the seal beads125at the sealed portions55of the cryopreservation bags.

According to the sealing apparatus formed as described above, it is possible to automatically seal the inlet/outlet3of the cryopreservation bag formed by the fluorine-based resin sheets S1and S2by moving the movable pinching block69with the clamp actuator70to clamp the sealed portion55and then actuating the scanning structure58and the laser device57. The sealing operation of the sealed portion55of the cryopreservation bag is carried out by users on the site such as doctors and medical technologists. Because a series of welding operations is carried out automatically after the sealed portion55is clamped by the bag clamping device56, it is possible to safely and properly carry out the sealing treatment of the cryopreservation bag. Moreover, the sealing treatment is always carried out automatically under constant conditions and therefore there is no variation between welding results. As a result, it is possible to provide the sealing apparatus for the cryopreservation bag, with which anyone can easily carry out the sealing treatment which can stably impart the high sealing function.

Because the movable pinching block69and the fixed pinching block67face the outer face of the scanning window66, it is possible to easily attach and detach the sealed portion55to and from the bag clamping device56on the outer face of the scanning window66facing a free space. Therefore, it is possible to appropriately clamp the sealed portion55with the bag clamping device56while checking a position and an attitude of the cryopreservation bag or it is possible to reliably retrieve the cryopreservation bag after the welding operation is finished, which improves overall usability of the sealing apparatus.

If the movable pinching block69is supported to be able to slide forward and backward with respect to the guide shafts68of the fixed pinching block67, the movable pinching block69can be smoothly moved forward and backward with respect to the fixed pinching block67and the parallelism between the pinching faces of both the pinching blocks67and69can be enhanced. Moreover, if the clamp actuator70is provided to the inner base84fixed to the guide shafts68, the movable pinching block69can be operated forward and backward by the clamp actuator70with the simpler structure and the sealed portion55can be reliably clamp-fixed between both the fixed and movable pinching blocks67and69.

The movable pinching block69is detachably mounted to the block support shafts81by the first screw bodies83and the heat radiator holder75is detachably mounted to the block base73by the second screw bodies77. According to the sealing apparatus, the movable pinching block69and the heat radiator holder75can be detached from the block support shafts81and the block base73as necessary and the movable pinching block69and the heat radiator holder75to which the biological tissue may be attached can be sterilized. Therefore, it is possible to facilitate hygiene control of the movable pinching block69, the heat radiator74, and the heat radiator holder75to safely carry out the sealing treatment of the sealed portion55of the cryopreservation bag from a hygiene perspective.

Although the seal beads125are formed continuously from one end to the other end of the sealed portion55in the above embodiment, this is not necessary. It suffices if the seal beads125are formed across at least the inlet/outlet3. Although the two seal beads125are formed by forming the return seal bead125beside the outgoing seal bead125in the above embodiment, the sealed portion55may be sealed with only any one of the outgoing and return seal beads125. If necessary, it is possible to actuate the vertical scanning actuator99in synchronization with the feeding operation of the scanning structure58to thereby form the seal beads125in continuous wave patterns or sawtooth patterns.

FIGS. 14 and 15show a variation of the cryopreservation bag. Here, an infrared laser beam is radiated to two layered transparent fluorine-based resin sheets S1and S2to form paired left and right outline beads1in an interface between both the sheets S1and S2to thereby form a housing portion132for housing biological tissue, a vent hole133continuous with the housing portion2, and an air bleed portion134continuous with the vent hole133in an area between both the sheets S1and S2and between the outline beads1. A portion of the air bleed portion134near an end portion is sealed with a first seal bead135. The vent hole133is formed at a center in a left-right direction of bag walls.

The housing portion132is defined by the paired left bead portion136and right bead portion137and shoulder bead portions138inclined in a tapered shape from both the bead portions136and137toward the vent hole133, upper end portions of both the left and right bead portions136and137intersect a short-side portion of the fluorine-based resin sheets S1and S2at right angles, and a filling hole139through which the biological tissue is filled into the housing portion132is open between both the bead portions136and137. The air bleed portion134is formed in a funnel shape. As shown inFIG. 15, a left-right width of the air bleed portion134is set to be sufficiently larger than a left-right width of the vent hole133and a left-right width of the housing portion132is set to be even larger than the left-right width of the air bleed portion134.

The cryopreservation bag formed as described above is sealed after the biological tissue such as blood is filled into the housing portion132and a series of operations is carried out by the following procedure.

First, as shown inFIG. 15, the filling hole139is oriented upward and opened and then the biological tissue is filled into the housing portion2from the filling hole139(step1). At this time, the biological tissue can be filled from the wide-open filling hole139having the same width as the housing portion132and therefore the biological tissue can be filled or poured into the housing portion2easily and quickly. Next, by bringing the bag walls on a side of the filling hole139into close contact with each other while pushing air out of the housing portion132, the side of the filling hole139of the cryopreservation bag filled with the biological tissue is sealed with second seal beads140as shown inFIG. 16(step2). The housing portion2in this state includes a small amount of air in many cases. In order to release the air, the bag walls are cut along a cutoff line141along the first seal bead135to separate and remove the bag walls including the first seal bead140to form an air bleed opening142near the end portion of the air bleed portion4(step3).

The cryopreservation bag in which the air bleed opening142is formed is erected and held with the air bleed portion134positioned above the housing portion132. Next, a liquid level is raised by pushing the biological tissue in the housing portion132out from the vent hole133into the air bleed portion134and air is released from the air bleed opening142while the bag walls of the air bleed portion134are brought into close contact with each other (step4). At this time, all the air in the air bleed portion134can be reliably exhausted by releasing the air from the air bleed opening142while bringing the bag walls of the wide air bleed portion134into close contact with each other. Furthermore, a provisional sealed portion143can be formed by bringing the bag walls between the air bleed portion134and an upper portion of the housing portion132into close contact with each other. By sealing the provisional sealed portion143with a third seal bead144in this state (step5), it is possible to seal only the biological tissue in the housing portion132.

According to the above-described cryopreservation bag, the biological tissue can be filled from the wide open filling hole139having the large width and therefore the biological tissue can be filled or poured into the housing portion132easily and quickly. Moreover, the liquid level can be raised by pushing the biological tissue in the housing portion2out from the vent hole133into the wide air bleed portion134and the air can be released from the air bleed opening142while the bag walls of the air bleed portion134are brought into close contact with each other. Therefore, it is possible to easily and quickly exhaust the air trapped in the housing portion132. The first seal bead135can be formed in a manufacturing process of the cryopreservation bag while the second seal beads140and the third seal bead144are formed by using the sealing apparatus.

Besides the above-described variation, the clamp actuator70does not necessarily have to be the solenoid but may be an electric slider, an electric cylinder, a liner actuator, or the like. Similarly, the scanning actuator93may be formed by an electric cylinder, a linear actuator, or the like besides the electric slider. Furthermore, the vertical adjustment actuator99and the focus adjustment actuator112may be formed by an electric slider, an electric cylinder, a linear actuator, or the like. The laser oscillator104may be disposed in such an attitude to be long in a lateral direction or a front-back direction. Although the sealing apparatus according to the invention is especially suitable to the sealing treatment of the sealed portion of the cryopreservation bag formed by the fluorine-based resin sheets S1and S2, the sealing treatment can be equally carried out for a cryopreservation bag formed by resin sheets other than the fluorine-based resin sheets. Therefore, the cryopreservation bag to be sealed is not limited to the bag formed by the fluorine-based resin sheets S1and S2.

REFERENCE SIGNS LIST