JP4997638B2 - Frozen drug thawing device - Google Patents

Description

  The present invention relates to a frozen product thawing device, and more particularly, a device for thawing a frozen product in a heated water tank system that enables thawing at an appropriate temperature, reduction of the risk of bacterial contamination, safety work, quality control, and work efficiency improvement. It is about.

  Typical frozen preparations include blood preparations such as FFP preparations and erythrocyte preparations. The FFP preparation is obtained by freezing plasma obtained from donated blood within 6 hours after blood collection. The FFP preparation stored at −20 ° C. or lower is thawed at a temperature of 30 to 37 ° C. in the United States. Or it is said that it will be thawed in a microwave oven approved by the US Food and Drug Administration (FDA). On the other hand, in Japan, when thawing in a constant temperature water bath of 30 to 37 ° C or a container filled with 37 ° C of hot water, use a thermometer and keep warm to a temperature of 30 to 37 ° C by adding warm water as appropriate. However, the method is different for each hospital facility and is currently not unified.

  The administration of FFP is performed for the purpose of correcting bleeding tendency due to lack of coagulation factors, and in particular, to bring about a hemostatic effect by supplementing a plurality of coagulation factors. However, if the temperature at the time of thawing is not appropriate, it is necessary to adversely affect the FFP preparation, and thawing at a high temperature may cause protein denaturation. On the other hand, if thawing at a low temperature, insoluble cryoprecipitate may be generated. Therefore, temperature control at the time of thawing is very important. Since reduction of contamination risk, safety work, quality control, improvement of work efficiency, etc. are required, development of a dedicated FFP thawing apparatus with a shortened FFP thawing time and a simple operation method satisfying those conditions is required. It is desired.

  The thawing methods that have been adopted globally from the past include the heated water tank method, air heating method, microwave method and warm sac method, and dedicated thawing devices with the advantages of each method have been commercialized. Yes. The features of the heated water tank method, air heating method, microwave method and warm sac method are briefly described below.

  The warming water tank method is a so-called hot water water bath method, and it is easy to manage the water temperature by stirring hot water, and has the advantages of water temperature control and water temperature stability. However, there are drawbacks such as floating the frozen preparation in the water tank and requiring exchange of hot water.

  Further, the air heating method is a hot air circulation method using a so-called blower, and has an advantage that the frozen preparation is not floated in the water tank and does not exchange hot water, which are disadvantages of the water bath method. However, there are drawbacks that it is difficult to uniformly warm the entire preparation and that temperature control and temperature stability are relatively difficult.

  Furthermore, the microwave method is a heating method using a so-called microwave oven, and has an advantage that work is easy. However, a microwave oven approved by the US Food and Drug Administration (FDA) must be used, and temperature control is relatively difficult.

  The warm sac system is a system in which a so-called warm water-filled bag body is brought into contact and has an advantage that it is hygienic because it does not directly contact warm water. However, since the warming to the preparation is indirect, there is a disadvantage that it takes time for thawing.

  In view of the above, the proposal of an air heating method that solves these problems, “thawing device for frozen plasma” (Patent Literature 1) and “thawing device for frozen blood” (Patent Literature 2), metal powder and activated carbon Proposal by heating consisting of powder or the like “Warming device made of frozen plasma” (Patent Document 3) has been proposed, but all of them have improved structure and method, but the above-mentioned thawing method It did not provide the fundamental strengths that straddled, nor compensated for the common drawbacks.

JP 2001-218817 A JP-A-62-189073 JP 2006-149678 A US Frozen Bag Automatic Defroster Product Catalog

  In view of the above problems, an object of the present invention is to provide a frozen preparation thawing device that enables thawing at an appropriate temperature, reduction of the risk of bacterial contamination, safe work, quality control, and work efficiency improvement.

In order to achieve the above object, the present invention provides a frozen product thawing device comprising a protector holder, a protector bag, a shaking unit, a control unit, and a thermostatic water bath, wherein the protector holder has a frame structure. The protector bag has a holding means for holding the protector bag at a predetermined position, and the protector bag has an opening on the upper side, and is locked to the protector holder at a position corresponding to the holding means provided in the protector holder. The shaking unit is composed of a fixed frame and a shaking frame, and the fixed frame can be placed on the upper side of the constant temperature water tank and has a structure equipped with a wave-dissipating plate below. A holding mechanism for holding the protector holder is provided and the shaking generated by the shaking generating mechanism is transmitted. The control unit has a structure that can be placed on the upper side of the thermostatic water tank, and at least the occurrence of shaking is supported by a fixed frame so that it can be shaken up and down about one side as a pivot. The structure includes a mechanism, a temperature management mechanism, and a stirring mechanism.

  In addition, the present invention can adopt a configuration in which the protector holder includes a U-shaped frame and a C-shaped frame connected to the upper outer side of the U-shaped frame.

  Furthermore, this invention can employ | adopt the structure by which the opening part of the said protector bag is folded outside.

  Furthermore, the present invention can adopt a configuration in which the protector bag is transparent or translucent.

  And this invention can also take the structure where the said constant temperature water tank is transparent or translucent.

  According to the frozen product thawing device according to the present invention, the frozen product stored in a protector bag is sealed in a protector bag and isolated from the warm water in the thermostatic water tank, so that the contents due to the breakage of the frozen product flow into the warm water. The risk of bacterial contamination of the frozen product can be reduced, and the frozen product is held in a protector bag made of a soft material to prevent damage to the frozen product due to contact with protrusions. Furthermore, since the frozen product is suspended in a vertically standing state and softly tightly wrapped by the water pressure in the thermostatic water tank, the temperature is uniformly transmitted to the entire frozen product, so that efficient thawing is achieved. Is possible.

  Further, according to the frozen product thawing device according to the present invention, the protector bag is immersed in the constant temperature water tank by the immersion of the protector holder by its own weight, so that the floating phenomenon of the frozen product enclosed in the protector bag is prevented. The protector holder that holds the frozen preparation can be locked in an obliquely leaning state by the holding mechanism in the shaking frame, so that it is possible to enter and exit the preparation without touching the hot water. Further, it is possible to finely adjust the preparation administration waiting time.

  Furthermore, according to the frozen preparation thawing device according to the present invention, by making the protector bag transparent or translucent, further, by making the thermostatic water tank transparent or translucent, the visibility inside the water tank is increased, The progress of thawing can be confirmed from the outside at any time, which contributes to early detection of a damaged preparation.

  Furthermore, according to the frozen product thawing device according to the present invention, the protector holder, the protector bag, the shaking unit, the control unit, and the constant temperature bath can be easily separated from each other, so that the disassembly work in maintenance such as component replacement is possible. Cleaning and cleaning work can be easily performed.

  Furthermore, according to the frozen preparation thawing apparatus according to the present invention, the frozen preparation can be shaken in the water tank by the shaking generation mechanism and the shaking unit provided in the control unit, thereby enabling efficient early thawing.

  In addition, according to the frozen preparation thawing device according to the present invention, the frozen preparation bag can be prevented from directly contacting the warm water by the frozen preparation being stored in the protector bag. There is also an advantage that the protector bag is hygienic because it can be replaced with a new one for a while.

  Hereinafter, embodiments of a frozen preparation thawing device according to the present invention will be described in detail with reference to the drawings.

1 and 2 show a frozen product thawing device 1 according to the present invention, FIG. 1 is a perspective view, and FIG. 2 is an exploded perspective view.
The frozen preparation thawing device 1 includes a protector holder 8, a protector bag 6, a shaking unit 3, a control unit 4, and a constant temperature water bath 5.

The frozen preparation thawing apparatus 1 according to the present invention can be easily separated from each unit as shown in FIG. That is, FIG. 2 shows a state where each unit is separable.
By adopting a configuration in which each unit can be easily separated, it is possible to easily perform disassembling work and cleaning work in maintenance such as parts replacement.

FIG. 3 is an explanatory view showing the protector holder 8 and the protector bag 6 in the frozen product thawing device 1 according to the present invention.
The protector holder 8 has a frame structure and includes holding means 9 for holding the protector bag 6 at a predetermined location.

  As shown in the drawing, the protector holder 8 can employ a structure including a U-shaped frame 8a and a C-shaped frame 8b connected to the upper outer side of the U-shaped frame 8a. With this structure, the upper end portion of the U-shaped frame 8a can function as the holding means 9b of the protector bag 6, and the C-shaped frame 8b is inserted into and removed from the constant temperature water tank 5 with the protector holder 8. It is possible to fulfill the handle function at the time of this.

  Further, both end portions of the C-shaped frame 8b (portions protruding outward from the U-shaped frame 8a) serve as a locking function when the protector holder 8 is inserted into the shaking unit 3. That is, when the protector holder 8 is inserted into the shaking unit 3, both ends of the C-shaped frame 8b are hooked on the holding mechanism 14 provided in the shaking frame 10 of the shaking unit 3, and the protector holder 8 is further inserted. It will be locked at the position where it does not.

  The material of the protector holder 8 is not particularly limited, but is preferably made of a material having a heavy mass such as metal. By using a heavy material such as metal, when the protector bag 6 is immersed in the constant temperature water tank 5, the protector holder 8 is immersed by its own weight, and the frozen preparation F enclosed in the protector bag 6 The floating phenomenon can be prevented.

  The protector bag 6 has an opening 6 a on the upper side, and includes a locking means 7 for the protector holder 8 at a position corresponding to the holding means 9 provided in the protector holder 8.

  About the opening part 6a of the protector bag 6, the structure currently folded outside can be employ | adopted. By adopting such a structure, the opening end has a thickness, and when the frozen preparation F is inserted into the protector bag 6 from the opening 6a, it can be inserted smoothly, and conversely, the frozen preparation F can be inserted. When taking out the hand, even if a hand is inserted through the opening 6a, the work can be smoothly performed without being caught by the opening end.

  The protector bag 6 is preferably transparent or translucent. By being transparent or translucent, the visibility in the protector bag 6 is increased, the progress of thawing can be confirmed from the outside, and it contributes to early detection of a damaged preparation.

  The protector bag 6 is preferably made of a flexible material. By using a flexible material, it is possible to hold the preparation itself with water pressure of hot water, and to reduce or prevent the risk of damage to the preparation.

  The shaking unit 3 includes a fixed frame 11 and a shaking frame 10.

  The fixed frame 11 has a structure that can be placed on the upper side of the constant temperature water tank 5. In order to fix the fixed frame 11 when the fixed frame 11 is placed on the upper side of the constant temperature water tank 5, for example, as shown in FIG. 2, a locking means 11 a is provided on the fixed frame 11 side, and a holding means is provided on the constant temperature water tank 5 side. A structure with 5a can be considered.

  The shaking frame 10 includes a holding mechanism 14 for holding the protector holder 8 and a transmission mechanism 26 for transmitting shaking by the shaking generating mechanism 19.

  The holding mechanism 14 has a structure in which one or more recesses 14 a into which the frame of the protector holder 8 can be inserted are formed so as to accept the insertion of the protector holder 8. The number of recesses 14a in one holding mechanism 14 is not particularly limited, but a plurality of recesses 14a are preferably provided, and are determined in consideration of the thawing efficiency of FFP preparation F, the size of FFP hot water thawing apparatus 1 as a whole, and the like. . Moreover, it is preferable to shape the upper end of the recess 14a into a shape that gradually expands toward the upper end as shown in the drawing so that the protector holder 8 can be easily inserted.

  Such holding mechanisms 14 are provided in pairs on opposite sides of the shaking frame 10, hold the U-shaped frame 8 a of the protector holder 8, and engage both ends of the C-shaped frame 8 b.

  In addition, as shown in FIG. 7, the aspect which further provides the concave hollow 14b in the intermediate position of the recessed part 14a in the holding mechanism 14 of at least one side can be considered. By adopting such an aspect, as shown in FIGS. 6A and 7A, when trying to lean the protector holder 8 on the shaking unit 3, one curved portion of the U-shaped frame 8a It enters into the concave recess 14b and is stably held, which contributes to improvement of work efficiency.

  The shaking frame 10 is pivotally supported by the fixed frame 11 so that it can be shaken up and down about one side as a pivot axis 15. A transmission mechanism 26 for transmitting the shaking by the shaking generation mechanism 19 is provided on the side facing the rotation pivot 15, and the transmission mechanism 26 shakes up and down by the operation of the shaking generation mechanism 19. As a result, the shaking frame 10 is shaken up and down with one side pivotally supported by the fixed frame 11 as a pivot axis 15.

Incidentally, in shake unit 3, as shown in the drawings, the fixed frame 11, Shonamiban 27 below its has become a provided structure. When the shaking frame 10 is shaken, the held protector holder 8 and the protector bag 6 are shaken in the warm water of the constant temperature water tank 5, and at that time, waves are generated in the hot water. Such waves cause hot water to spill over the constant temperature bath 5. Therefore, by providing such a wave-dissipating plate 27, it is possible to cancel waves generated by shaking and prevent hot water spillage.

  The control unit 4 controls the occurrence of shaking, the temperature management of hot water, and the like, and has a structure that can be placed on the upper side of the constant temperature water tank 5. In order to fix the control unit 4 when the control unit 4 is placed on the upper side of the constant temperature water tank 5, for example, as shown in FIG. 2, the control unit 4 is provided with a locking means 4a, and the constant temperature water tank 5 is provided with a holding means. A structure with 5b can be considered.

The control unit 4 includes at least a shaking generation mechanism 19, a temperature management mechanism 20, and a stirring mechanism 21.
The shaking generation mechanism 19 is for shaking the shaking unit 3 via a transmission mechanism 26 from a centering cam motor or the like built in the control unit 4.
The temperature management function 20 operates a heater, a thermo stud or the like built in the control unit 4 and manages the temperature management of the hot water.
The stirring function 21 is for stirring and circulating hot water so that the water temperature in the constant temperature water tank 5 is uniform by a screw motor or the like built in the control unit 4.

In addition to the above-described mechanism, the control unit 4 can incorporate various mechanisms such as a time control mechanism, a safety mechanism, and a power supply circuit mechanism as required.
These mechanisms are operated and set by the operation panel 18 on the control unit 4, and each mechanism is automatically or manually controlled by the operation and setting.

  The constant temperature water tank 5 has a structure in which the shaking water 3 and the control unit 4 can be placed while storing warm water, and a structure provided with holding means 5a and 5b on the upper side of the constant temperature water tank 5 to hold each unit. It has become.

  The constant temperature water tank 5 is preferably transparent or translucent. By being transparent or translucent, visibility in the constant temperature bath 5 is increased, and the synergistic action of the protector bag 6 with the transparency and translucency allows the progress of thawing to be confirmed from the outside and early detection of a damaged preparation. It will also contribute to.

4 to 7 are side views showing an embodiment of the frozen product thawing device 1.
In the frozen preparation thawing apparatus 1, the shaking unit 3 and the control unit 4 are placed on the upper side of the constant temperature water bath 5. The temperature management mechanism 20 provided in the control unit 4 measures the water temperature in the constant temperature water tank 5 with a thermostud or the like, and performs ON / OFF control of the heater or the like according to the measured value. Further, the stirring mechanism 21 provided in the control unit 4 performs stirring / circulation of the hot water in the constant temperature water tank 5 by a screw motor or the like. The water flow at that time is indicated by black arrows in FIG.

  As shown in FIG. 5, the operation by the eccentric cam motor or the like of the shaking generation mechanism 19 provided in the control unit 4 is transmitted to the shaking unit 3 via the transmission mechanism 26, so that the shaking unit 3 is moved up and down in conjunction with each other. Shake on. As a result, the protector holder 8 held in the shaking unit 3 via the holding means 14 is similarly shaken up and down, and the protector bag 6 held in the protector holder 8 is shaken up and down. The frozen preparation F inserted in the protector bag 6 is shaken up and down.

  In addition, although it does not specifically limit about the frequency | count per unit time of shaking, The grade which reciprocates up and down in the range of 140 to 180 times per minute is preferable. If it is slow (less than 140 times per minute), there is no effect on accelerating the thawing time by shaking, and conversely if it is too early (more than 180 times per minute). .

  The shaking stroke (vertical movement distance) is preferably around 20 mm. If the stroke is small, the structure can be reduced in size, but the influence on thawing that shakes is reduced. Conversely, if the stroke is large, the influence of shaking is large, but the structure is enlarged. In addition, problems such as intense hot water in the water tank occur. Therefore, considering the influence of shaking on thawing and structural miniaturization, the shaking stroke is preferably about 20 mm.

As shown in FIGS. 6 (a) and 7 (a), the protector holder 8 can also be locked in a leaning state on the shaking unit 3 when the frozen preparation F is put in and out of the protector bag 6. It has a structure, and it is possible to improve work efficiency and hygiene when the frozen preparation F is in and out, and to finely adjust the preparation administration waiting time.
When the protector holder 8 is inserted into and removed from the shaking unit 3, the C-shaped frame 8b performs a handle function.

FIG. 8 is a graph and a table showing the thawing performance of the frozen product thawing apparatus 1. In addition, this thawing | decompression performance is based on the experimental example about the thawing | decompression of a FFP formulation.
FIG. 8A is a graph showing the time required for the thawing performance by this apparatus. As can be seen from the drawing, the conventional control group spent an average of 17.0 minutes to completely thaw FFP-1, whereas this device group could thaw in an average of 4.6 minutes. did it.

  FIG. 8B is a graph regarding the required thawing time for each unit and bag number according to the present apparatus. An average of 5.1 minutes was measured with FFP-1, an average of 8.8 minutes with FFP-2, and an average of 14.5 minutes with FFP-5. With the three types of FFP preparations F, results were obtained in which the thawing time did not increase even when the number of bags increased to four.

  FIG.8 (c) is a graph which shows the water temperature fluctuation | variation of the warm water stored in the water tank 5 at the time of thawing | decompression by this apparatus. In FFP-1 and FFP-2, there is no change in water temperature in 1 to 4 bags and the number of bags, and the temperature condition is stable at 37 ° C. In FFP-5, no change in temperature was observed until the thawing of 1-2 bags, but the water temperature decreased to 36 ° C by 1 minute after thawing of 3 bags, and the water temperature increased to 37 ° C at the end of thawing. And stable. In the case of 4 bags, the water temperature gradually decreased from the start of thawing, and the minimum temperature was 34.4 ° C. after 10 minutes. After the thawing was completed, the water temperature rose again, and then returned to 37 ° C. in 5 minutes and a stable result was obtained.

FIG. 8 (d) is a data table showing the measurement results of clotting factor activity by this apparatus. The prothrombin time (PT) was 88.2% in this device group and 81.7% in the control group, showing a significant difference (p <0.005).
There was no significant difference in the activated partial thromboplastin (APTT), fibrinogen, and unstable coagulation factors (factors 5 and 8) of other items.

  According to the present invention, human body parts, human body fluids, frozen medical drugs, research materials, medical samples, bacterial culture drugs, etc. can be applied to pharmaceuticals and food medical institutions and research fields that are thawed for each purpose of use. And its application range is wide. Therefore, it is understood that the industrial applicability of the frozen product thawing device 1 according to the present invention is extremely high.

It is a perspective view which shows the frozen formulation thawing | decompression apparatus concerning this invention. It is a disassembled perspective view which shows the frozen formulation thawing | decompression apparatus concerning this invention. It is explanatory drawing which shows the protector holder and protector bag in the frozen preparation thaw | decompression apparatus concerning this invention. It is a side view which shows the embodiment of the frozen preparation thawing | decompression apparatus concerning this invention. It is a side view which shows the embodiment of the frozen preparation thawing | decompression apparatus concerning this invention. It is a side view which shows the embodiment of the frozen preparation thawing | decompression apparatus concerning this invention. It is an expansion perspective view which shows the holder holding plate in the frozen preparation thawing | decompression apparatus concerning this invention. It is the graph and table | surface which show the thawing | decompression performance of the frozen formulation thawing | decompression apparatus concerning this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Frozen preparation thawing apparatus 3 Shaking unit 4 Control unit 5 Constant temperature water tank 6 Protector bag 7 Locking means 8 Protector holder 9 Holding means 10 Shaking frame 11 Fixed frame 14 Holding mechanism 15 Rotating pivot 18 Operation panel 19 Shaking generation mechanism 20 Temperature management Mechanism 21 Agitation mechanism 26 Transmission mechanism 27 Dissipating plate F Frozen preparation

Claims (5)

A frozen product thawing device comprising a protector holder, a protector bag, a shaking unit, a control unit, and a constant temperature water bath,
The protector holder has a frame structure, and includes a holding means for holding the protector bag at a predetermined position.
The protector bag has an opening on the upper side, and includes a locking means for the protector holder at a location corresponding to the holding means provided on the protector holder,
The shaking unit is composed of a fixed frame and a shaking frame. The fixed frame can be placed on the upper side of the thermostatic water tank and has a structure equipped with a wave-dissipating plate below . The shaking frame holds the protector holder. A holding mechanism for carrying out, and a transmission mechanism for transmitting the shaking by the shaking generating mechanism, and pivotally supported by the fixed frame so as to be able to shake up and down with one side as a pivot axis,
The control unit has a structure that can be placed on the upper side of the constant temperature water tank, and is provided with at least a shaking generation mechanism, a temperature management mechanism, and a stirring mechanism.   The frozen product thawing device according to claim 1, wherein the protector holder includes a U-shaped frame and a C-shaped frame connected to an upper outer side of the U-shaped frame. The frozen product thawing device according to claim 1 or 2 , wherein an opening of the protector bag is folded outward. The frozen product thawing device according to any one of claims 1 to 3 , wherein the protector bag is transparent or translucent. The frozen preparation thawing device according to any one of claims 1 to 4 , wherein the constant-temperature water tank is transparent or translucent.

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