(19)
(11)EP 3 295 974 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
13.05.2020 Bulletin 2020/20

(21)Application number: 17191827.9

(22)Date of filing:  19.09.2017
(51)Int. Cl.: 
A61M 1/02  (2006.01)
A61J 1/10  (2006.01)
A61J 1/16  (2006.01)
A61J 1/05  (2006.01)
A61J 1/14  (2006.01)
A61J 1/20  (2006.01)

(54)

MEDICAL PREPARATION DIVIDING UNIT AND MEDICAL PREPARATION DIVIDING METHOD

EINHEIT ZUR TEILUNG EINES MEDIZINISCHEN PRÄPARATS UND VERFAHREN ZUR TEILUNG EINES MEDIZINISCHEN PRÄPARATS

UNITÉ DE DIVISION DE PRÉPARATION MÉDICALE ET PROCÉDÉ DE DIVISION DE PRÉPARATION MÉDICALE


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 20.09.2016 JP 2016182879

(43)Date of publication of application:
21.03.2018 Bulletin 2018/12

(73)Proprietor: Terumo Kabushiki Kaisha
Shibuya-ku Tokyo (JP)

(72)Inventors:
  • HOSOE, Kaoru
    Shizuoka, 418-0004 (JP)
  • NAGATA, Koudai
    Shizuoka, 418-0004 (JP)

(74)Representative: Casalonga 
Casalonga & Partners Bayerstraße 71/73
80335 München
80335 München (DE)


(56)References cited: : 
WO-A1-2015/149098
CN-Y- 201 192 459
US-A- 4 994 039
US-A1- 2012 171 658
CN-A- 101 953 750
US-A- 3 187 750
US-A- 5 356 373
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    BACKGROUND


    Technical Field



    [0001] The present invention relates to a medical preparation dividing unit and a medical preparation dividing method for dividing a medical preparation stored in a storage member into a plurality of division bags by head.

    Related Art



    [0002] To effectively use a blood preparation, division of the blood preparation is performed in each hospital in a case of transfusing blood into a newborn infant or an immature infant, where the volume of single blood transfusion is small. The division of the blood preparation is performed by absorbing the blood preparation in a blood sampling bag with a syringe. However, this method has a risk of contamination of the blood preparation (for example, see Mitsuhiro Fujishima and three others, 2003, "Transfusion of Divided Red Blood Cells During Neonatal Period", Journal of the Japan Society of Blood Transfusion, Vol. 49, No. 3, pp. 426-431).

    [0003] Further, Mitsuhiro Fujishima and three others, 2003, "Transfusion of Divided Red Blood Cells During Neonatal Period", Journal of the Japan Society of Blood Transfusion, Vol. 49, No. 3, pp. 426-431 describes a method of connecting a blood sampling bag and a plurality of division bags through a branch tube in an aseptic condition, and transferring a blood preparation in the blood sampling bag into the division bags.

    [0004] Relevant prior art is for instance disclosed in documents WO2015/149098 A1, US5356373 A, CN101953750 A, US4994039 A, US3187750 A, US 2012/171658 A1 and CN201192459 Y.

    SUMMARY



    [0005] By the way, in a case of transferring a medical preparation such as the blood preparation in the blood sampling bag (storage member) into the plurality of division bags while causing the medical preparation to head from above to below in the branch tube, the medical preparation is nonuniformly divided into the plurality of division bags due to nonuniformity of resistance in the branch portion provided to the medical preparation at the time of heading. Therefore, to divide the medical preparation into the plurality of division bags in an approximately uniform manner, the medical preparation in the division bags needs to be measured and adjusted, and the work is troublesome.

    [0006] The present invention has been made in view of such a problem, and an objective is to provide a medical preparation dividing unit and a medical preparation dividing method that enable approximately uniform division of a medical preparation in a storage member into a plurality of division bags by simple and easy work.

    [0007]  To achieve the objective, a medical preparation dividing unit according to the present invention is defined by the technical features of independent claim 1.

    [0008] According to the configuration, when the medical preparation in the storage member is brought to head in the head tube in a state where the plurality of division bags is held with the holding tool, the medical preparation introduced from the head tube flows into the plurality of branch tubes while pushing up the air in the branch portion. With the configuration, in the branch portion and the branch tubes, the medical preparation receives gravity in an opposite direction to a proceeding direction of the fluid (medical preparation) . Therefore, flow separation in the branch portion and the branch tubes is suppressed, and influence of nonuniformity of a tube shape on the branch portion and the branch tubes can be reduced. Therefore, as a result, the medical preparation can be approximately uniformly transferred to the branch tubes. Then, the medical preparations through the branch tubes are approximately uniformly transferred to the plurality of division bags having the inlets having the same shape and the same size as one another and held at the same height. Therefore, the medical preparation in the storage member can be approximately uniformly divided into the plurality of division bags by simple and easy work.

    [0009] The medical preparation dividing unit may further include a shape holding tool that holds the other end side of the head tube into a curved shape so that the medical preparation is introduced through the head tube into the branch portion from below.

    [0010] According to the configuration, the medical preparation in the branch portion can be reliably brought to flow upward.

    [0011] In the medical preparation dividing unit, flow path volumes of the plurality of branch tubes may be approximately the same as one another.

    [0012] According to the configuration, the medical preparation can be further uniformly transferred to the plurality of division bags.

    [0013] In the medical preparation dividing unit, central lines of the plurality of outlets of the branch portion may be positioned on the same circumference around a central line of the inlet of the branch portion.

    [0014] According to the configuration, the medical preparation introduced into the inlet of the branch portion can be uniformly transferred to the branch tubes with a simple configuration.

    [0015] In the medical preparation dividing unit, the holding tool includes a connection portion that connects the plurality of division bags with one another, and a mount portion provided to the connection portion and detachably mounted to the head tube.

    [0016] According to the configuration, the inlets of the plurality of division bags can be easily held at approximately the same height position by mounting the mount portion to the head tube.

    [0017] In the medical preparation dividing unit, a vulnerable portion may be formed in the connection portion so that the plurality of division bags is separable from one another.

    [0018] According to the configuration, the division bags can be separated from one another by breaking the vulnerable portion of the connection portion after the medical preparation in the storage member is divided into the plurality of division bags.

    [0019] The medical preparation dividing unit may further include a clamp capable of blocking or opening the head tube.

    [0020] According to the configuration, the clamp is opened and the medical preparation in the storage member can be divided into the plurality of division bags, after the plurality of division bags is held with the holding tool.

    [0021] A medical preparation dividing method of the present invention is defined by the technical features of independent claim 7.

    [0022] According to the method, the medical preparation in the storage member can be approximately uniformly divided into the plurality of division bags by simple and easy work.

    [0023] In the medical preparation dividing method, a shape holding process of holding the other end side of the head tube into a curved shape with a shape holding tool may be performed before the transfer process so that the medical preparation is introduced through the head tube into the branch portion from below.

    [0024] According to the configuration, in the transfer process, the medical preparation in the branch portion can be reliably brought to flow upward.

    [0025] In the medical preparation dividing method, a residual amount transfer process of causing the medical preparation in the head tube to flow downward to the division bags through the branch portion and the branch tubes may be performed by canceling the holding of the plurality of division bags with the holding tool after the transfer process.

    [0026] According to the method, the total amount of the medical preparation in the storage member can be divided into the plurality of division bags.

    [0027] In the medical preparation dividing method, the holding tool may include a connection portion that connects the plurality of division bags with one another, and a separation process of separating the plurality of division bags from one another may be performed by cutting the connection portion after the residual amount transfer process.

    [0028] According to the method, a plurality of division bags can be individually stored and used.

    [0029] According to the present invention, when a medical preparation in a storage member is caused to head into a head tube, the medical preparation introduced through the head tube into an introduction portion of a branch connector flows into a plurality of branch ports while pushing up the air in the branch connector from below. Therefore, the medical preparation in the storage member can be approximately uniformly divided into a plurality of division bags by simple and easy work.

    BRIEF DESCRIPTION OF DRAWINGS



    [0030] 

    FIG. 1 is a schematic front view of a medical preparation dividing unit according to an embodiment of the present invention;

    FIG. 2 is a schematic side view of the medical preparation dividing unit in FIG. 1;

    FIG. 3A is a sectional view along a IIIA-IIIA line in FIG. 2, FIG. 3B is a sectional view along a IIIB-IIIB line in FIG. 3A, and FIG. 3C is a sectional view along a IIIC-IIIC line in FIG. 3B;

    FIG. 4 is a schematic diagram illustrating a state in which a connection process and a holding process of a medical preparation dividing method according to an embodiment of the present invention are completed;

    FIG. 5 is a schematic diagram illustrating the medical preparation dividing unit during a transfer process;

    FIG. 6A is a sectional schematic diagram illustrating a state in which a medical preparation flows in a first branch portion, and FIG. 6B is a sectional schematic diagram illustrating a state in which a medical preparation flows in a second branch portion;

    FIG. 7 is a schematic diagram illustrating a state in which the transfer process is completed;

    FIG. 8 is a schematic diagram illustrating the medical preparation dividing unit during a residual amount transfer process; and

    FIG. 9A is a first explanatory diagram illustrating a separation process and FIG. 9B is a second explanatory diagram illustrating the separation process.


    DETAILED DESCRIPTION



    [0031] Hereinafter, favorable embodiments about a medical preparation dividing unit and a medical preparation dividing method according to the present invention will be described with reference to the appended drawings.

    [0032] As illustrated in FIGS. 1 and 2, a medical preparation dividing unit 10 according to an embodiment of the present invention divides a medical preparation stored in a storage bag 100 (storage member) into a plurality of division bags 20a to 20d in an approximately uniform manner by head. As the medical preparation, a liquid preparation such as a blood preparation or a cell preparation is used, for example. Examples of the blood preparation include whole blood, packed red blood cells blood plasma, blood platelet, platelet-rich plasma, and platelet poor plasma.

    [0033] That is, the medical preparation dividing unit 10 can be used to divide blood (the medical preparation) stored in a blood sampling bag (the storage bag 100) into the plurality of division bags 20a to 20d in an approximately uniform manner in a case of transfusing blood into a newborn infant or an immature infant, where the volume of single blood transfusion is small.

    [0034] The medical preparation dividing unit 10 of the present embodiment is used to divide the medical preparation in one storage bag 100 (storage member) (see FIG. 4) into the four division bags 20a to 20d. Note that the medical preparation dividing unit 10 may be used to divide the medical preparation in one storage bag 100 into two, three, or five or more division bags 20a to 20d. Further, the medical preparation dividing unit 10 may be used to divide the medical preparation in two or more storage bags 100 into three or more (a larger number than the number of the storage bags 100) division bags 20a to 20d.

    [0035] The medical preparation dividing unit 10 includes a long head tube 12, a valve member 14 provided to one end of the head tube 12, a branch portion 16 provided to the other end of the head tube 12, a plurality of branch tubes 18a to 18d having one ends connected to the branch portion 16, and the plurality of division bags 20a to 20d having inlets 21a to 21d connected with the other ends of the branch tubes 18a to 18d.

    [0036] The head tube 12 is a transparent and flexible resin-made tube. The branch tubes 18a to 18d are similar to the head tube 12. The valve member 14 is an air vent for adjusting an internal pressure in performing high pressure steam sterilization (autoclave sterilization) of the medical preparation dividing unit 10, for example. The valve member 14 may be omitted in a case of applying ethylene oxide gas sterilization (EOG sterilization) or radiation sterilization (gamma sterilization) to the medical preparation dividing unit 10. A clamp 24 that blocks or opens the head tube 12 is provided to one end side (a middle portion) of the head tube 12.

    [0037] As illustrated in FIGS. 3A and 3B, the branch portion 16 includes first to third branch portions 26, 28, and 30. Each of the first to third branch portions 26, 28, and 30 is formed as a Y connector. In other words, the first to third branch portions 26, 28, and 30 are formed into the same shape and the same size as one another, and a combination of these members constitutes the branch portion 16.

    [0038] The first branch portion 26 includes a first leg portion 32 and two first arm portions 34 and 36 extending in a bifurcated manner from the first leg portion 32. A first introduction portion 32a (an inlet of the branch portion 16), in which the other end portion of the head tube 12 is provided, is formed in the first leg portion 32.

    [0039] A first branch port 34a communicating with the first introduction portion 32a is formed in the first arm portion 34. The first arm portion 36 formed similarly to the first arm portion 34, and a first branch port 36a communicating with the first introduction portion 32a is formed in the first arm portion 36. The first branch portion 26 is line-symmetrically formed with respect to a central line CL1 of the first introduction portion 32a, as an axis of symmetry.

    [0040] The second branch portion 28 is formed similarly to the first branch portion 26, and includes a second leg portion 38 provided in the first branch port 34a and two second arm portions 40 and 42 extending in a bifurcated manner from the second leg portion 38. A second introduction port 38a communicating with the first branch port 34a is formed in the second leg portion 38.

    [0041] A second branch port 40a communicating with the second introduction port 38a is formed in the second arm portion 40. The second branch port 40a is provided with one end portion of the branch tube 18a. The second arm portion 42 is formed similarly to the second arm portion 40, and a second branch port 42a communicating with the second introduction port 38a is formed in the second arm portion 42. The second branch port 42a is provided with one end portion of the branch tube 18b. That is, these second branch ports 40a and 42a function as outlets of the branch portion 16. An arranging direction of the second arm portions 40 and 42 is perpendicular to an arranging direction of the first arm portions 34 and 36.

    [0042] The third branch portion 30 is formed similarly to the first branch portion 26, and includes a third leg portion 44 provided in the first branch port 36a and two third arm portions 46 and 48 extending in a bifurcated manner from the third leg portion 44. A third introduction port 44a communicating with the first branch port 36a is formed in the third leg portion 44.

    [0043] A third branch port 46a communicating with the third introduction port 44a is formed in the third arm portion 46. The third branch port 46a is provided with one end portion of the branch tube 18d. The third arm portion 48 formed similarly to the third arm portion 46, and a third branch port 48a communicating with the third introduction port 44a is formed in the third arm portion 48. The third branch port 48a is provided with one end portion of the branch tube 18c. That is, these third branch ports 46a and 48a function as outlets of the branch portion 16. An arranging direction of the third arm portions 46 and 48 is perpendicular to an arranging direction of the first arm portions 34 and 36. That is, the arranging direction of the third arm portions 46 and 48 is the same as the arranging direction of the second arm portions 40 and 42.

    [0044] As illustrated in FIG. 3C, in the branch portion 16, the two second arm portions 40 and 42 (the second branch ports 40a and 42a) and the two third arm portions 46 and 48 (the third branch ports 46a and 48a) are point symmetrically provided with respect to the central line CL1 of the first introduction portion 32a. That is, a space L1 between the central line CL1 of the first introduction portion 32a and a central line CL2 of the second branch port 40a or 42a is approximately the same as a space L2 between the central line CL1 of the first introduction portion 32a and a central line CL3 of the third branch port 46a or 48a. In other words, the central lines CL2 and CL3 are positioned on the same circumference.

    [0045] In FIGS. 1 and 2, the branch tubes 18a to 18d are short tubes formed of a similar material to the head tube 12. The plurality of branch tubes 18a to 18d is formed into the same size and the same shape as one another. In FIGS. 1 and 2, for convenience, the length of the branch tubes 18a and 18d and the length of the branch tubes 18b and 18c are illustrated in different lengths. However, in reality, the plurality of branch tubes 18a to 18d has an equal length.

    [0046] The entire length of the branch tubes 18a to 18d is set to a length that enables joint of the branch tubes 18a to 18d with another tubes in an aseptic joining device after division of the medical preparation is completed and the branch tubes 18a to 18d are cut. To be specific, the entire length of the branch tubes 18a to 18d is 25 mm or more.

    [0047] The plurality of division bags 20a to 20d is formed into a shape having the same size and the same shape as one another. The division bags 20a to 20d are formed in such a manner that sheet material made of a soft resin such as polyvinyl chloride or polyolefin and having flexibility is layered, and a seal portion in a peripheral edge of the sheet material is fusion-bonded (thermal fusion or high-frequency fusion) or glued, and formed into a bag shape.

    [0048] The volume of each of the division bags 20a to 20d is set to 50 ml or more, for example. Note that the volume of the division bags 20a to 20d is smaller than the volume of the storage bag 100. The division bags 20a to 20d have inlets 21a to 21d to which the other end portions of the branch tubes 18a to 18d are provided.

    [0049] The medical preparation dividing unit 10 further includes a holding tool 50 and a shape holding tool 52. The holding tool 50 holds the inlets 21a to 21d of the plurality of division bags 20a to 20d at the same height position above the branch portion 16. The shape holding tool 52 holds the other end side of the head tube 12 in a curved shape.

    [0050] The holding tool 50 includes a connection portion 54 and a mount portion 56. The connection portion 54 connects end portions of the plurality of division bags 20a to 20d on an opposite side of the inlets 21a to 21d with one another. The mount portion 56 is provided to the connection portion 54 and is detachably mountable to the head tube 12. The connection portion 54 is formed of the resin material as the division bags 20a to 20d, for example. In the connection portion 54, a plurality of vulnerable portions 58 is formed so that the plurality of division bags 20a to 20d is separable from one another. The vulnerable portion 58 is formed in such a manner that a plurality of holes (perforation) is formed in the connection portion 54. Note that the vulnerable portion 58 is not limited thereto, and may have a thin-wall portion or a notch shape.

    [0051] A fitting groove 60 into which the head tube 12 is fittable is formed in the mount portion 56, for example. In this case, the mount portion 56 can be easily mounted to/dismounted from the head tube 12, and blockage of a flow path of the head tube 12 in a state where the mount portion 56 is mounted to the head tube 12 can be suppressed.

    [0052] The mount portion 56 is not limited to have the above configuration. The mount portion 56 may be formed of a tube-like member that can be tied to the head tube 12 or may be a belt-like member having an adhesive surface peelably adhering to the head tube 12. Further, the holding tool 50 is not limited to have the above configuration. The holding tool 50 may be a stand provided with a hook that can hang the plurality of division bags 20a to 20d at the same height position.

    [0053] The shape holding tool 52 is used to hold the other end side of the head tube 12 in an approximately U-shaped curved state, and is formed of a hard resin material into a rectangular shape in plan view. Two fitting grooves 62 and 64 into which the head tube 12 is mounted extending along the overall width of the shape holding tool 52 are formed in the shape holding tool 52, for example. The fitting grooves 62 and 64 are similarly formed to the fitting groove 60 of the mount portion 56 in such a manner that the head tube 12 is detachably mountable .

    [0054] The fitting grooves 62 and 64 are separated in a longitudinal direction of the shape holding tool 52. A separation space between the fitting grooves 62 and 64 is set to a distance in which the other end side of the head tube 12 can be curved at curvature by which the flow path of the head tube 12 is not blocked.

    [0055] The medical preparation dividing unit 10 according to the present embodiment is basically configured as described above. Next, a medical preparation dividing method of dividing the medical preparation in the storage bag 100 into the plurality of division bags 20a to 20d in an approximately uniform manner will be described. In the present embodiment, a holding process, a shape holding process, a connection process, a transfer process, a residual amount transfer process, and a separation process are performed in order.

    [0056] As illustrated in FIG. 1, in the holding process, the fitting groove 60 of the holding tool 50 is mounted to the one end side of the head tube 12. With the process, a curved portion 12a is formed on the other end side of the head tube 12, and the plurality of division bags 20a to 20d are held with the inlets 21a to 21d facing downward at the same height position.

    [0057] At this time, the first introduction portion 32a of the branch portion 16 is arranged above the curved portion 12a, and the second branch ports 40a and 42a and the third branch ports 46a and 48a of the branch portion 16 are arranged above the first introduction portion 32a. Further, the plurality of division bags 20a to 20d takes the same posture such that an extending direction of the division bag goes along an up and down direction (gravity direction) . In other words, the plurality of division bags 20a to 20d is held in the same posture with respect to a horizontal direction. A height H from a lowermost portion (a lower portion of the curved portion) of the head tube 12 to the mount portion 56 mounted to the head tube 12 is set to a dimension by which the branch tubes 18a to 18d are not bent.

    [0058] In the holding process, an end portion of the U-shaped curved portion 12a on the other end side of the head tube 12 is mounted to the fitting grooves 62 and 64 of the shape holding tool 52. With the process, the other end side of the head tube 12 is reliably held in the curved shame. Note that the other end side of the head tube 12 may be held in the curved shape in advance. In this case, the holding process may be provided.

    [0059] As illustrated in FIG. 4, in the connection process, the outlet of the storage bag 100 is joined with the one end of the head tube 12 in an aseptic condition in a state where the clamp 24 is blocked. In the description below, the entire medical preparation dividing unit 10 provided with the storage bag 100 in place of the valve member 14 is also called "medical preparation dividing unit 10".

    [0060] As illustrated in FIG. 5, in the transfer process, the clamp 24 is opened in the state where the storage bag 100 is arranged above the plurality of division bags 20a to 20d. At this time, the head tube 12 extends from the one end to the curved portion 12a along the gravity direction. When the clamp 24 is opened, the medical preparation in the storage bag 100 heads in the head tube 12, passes through the curved portion 12a, and flows into the first introduction portion 32a of the branch portion 16. In the branch portion 16, the medical preparation introduced into the first introduction portion 32a is transferred to the plurality of branch tubes 18a to 18d while pushing up the air in the branch portion 16.

    [0061] To be specific, as illustrated in FIG. 6A, the medical preparation introduced into the first introduction portion 32a is divided and transferred to the two first branch ports 34a and 36a in an approximately uniform manner. At this time, liquid levels LS of the medical preparation of the first branch ports 34a and 36a are positioned at the same height. Then, the medical preparation flowing upward in the first branch port 34a is introduced into the second introduction port 38a, and the medical preparation flowing upward in the first branch port 36a is introduced into the third introduction port 44a.

    [0062] Next, as illustrated in FIG. 6B, the medical preparation introduced into the second introduction port 38a is divided and transferred to the two second branch ports 40a and 42a in an approximately uniform manner, and the medical preparation introduced into the third introduction port 44a is divided and transferred to the two third branch ports 46a and 48a in an approximately uniform manner. At this time, liquid levels LS of the medical preparation of the second branch ports 40a and 42a and the third branch ports 46a and 48a are positioned at the same height.

    [0063] After that, the medical preparation in the second branch port 40a is introduced into the branch tube 18a, the medical preparation in the second branch port 42a is introduced into the branch tube 18b, the medical preparation in the third branch port 46a is introduced into the branch tube 18d, and the medical preparation in the third branch port 48a is introduced into the branch tube 18c (see FIG. 5). At this time, liquid levels LS of the medical preparation of the branch tubes 18a to 18d are positioned at the same height. Then, the medical preparations in the branch tubes 18a to 18d flow upward and flow through the inlets 21a to 21d into the division bags 20a to 20d. That is, the medical preparation headed in the head tube 12 from the storage bag 100 changes the direction in the curved portion 12a, flows upward in the branch portion 16, and is approximately uniformly divided into the division bags 20a to 20d through the branch tubes 18a to 18d.

    [0064] Then, as illustrated in FIG. 7, the transfer of the medical preparation to the division bags 20a to 20d is stopped when the liquid level LS of the medical preparation in the head tube 12 and the liquid levels LS of the medical preparation transferred to the division bags 20a to 20d are positioned at the same height. At this stage, the transfer process is terminated.

    [0065] As illustrated in FIG. 8, in the residual amount transfer process, when the mount portion 56 of the holding tool 50 is detached from the head tube 12, the branch portion 16 and the division bags 20a to 20d are arranged below the curved portion 12a in a vertically inverted state. At this time, the first introduction portion 32a of the branch portion 16 is arranged below the curved portion 12a, and the second branch ports 40a and 42a and the third branch ports 46a and 48a of the branch portion 16 are arranged below the first introduction portion 32a. Further, the plurality of division bags 20a to 20d are arranged with the inlets 21a to 21d facing upward at the same height position. With the arrangement, the medical preparation remaining in the head tube 12 flows downward in the branch portion 16 and is transferred to the plurality of division bags 20a to 20d through the branch tubes 18a to 18d, and the total amount of the medical preparation stored in the storage bag 100 is divided into the division bags 20a to 20d.

    [0066] As illustrated in FIG. 9A, in the separation process, the branch tubes 18a to 18d are welded and sealed by a tube sealer or the like, and then the branch tubes 18a to 18d are cut in the sealed portions. Then, as illustrated in FIG. 9B, the plurality of division bags 20a to 20d is separated from one another by breaking the vulnerable portions 58 of the connection portion 54.

    [0067] According to the present embodiment, when the medical preparation in the storage bag 100 is brought to head in the head tube 12 in the state where the plurality of division bags 20a to 20d is held with the holding tool 50, the medical preparation introduced from the head tube 12 flows into the plurality of branch tubes 18a to 18d while pushing up the air in the branch portion 16. With the process, in the branch portion 16 and the branch tubes 18a to 18d, the medical preparation receives gravity in an opposite direction to a proceeding direction. Therefore, flow separation in the branch portion 16 and the branch tubes 18a to 18d is suppressed, and influence of nonuniformity of a tube shape on the branch portion 16 and the branch tubes 18a to 18d can be reduced. Therefore, as a result, the medical preparation can be approximately uniformly transferred to the branch tubes 18a to 18d. Then, the medical preparations through the branch tubes 18a to 18d are approximately uniformly transferred to the plurality of division bags 20a to 20d having the inlets 21a to 21d having the same shape and the same size as one another and held at the same height. Therefore, the medical preparation in the storage bag 100 can be approximately uniformly divided into the plurality of division bags 20a to 20d by simple and easy work.

    [0068] Further, the other end side of the head tube 12 is held in the curved shape with the shape holding tool 52, and thus the medical preparation is introduced into the first introduction portion 32a of the branch portion 16 from below. Therefore, the medical preparation in the branch portion 16 can be reliably brought to flow upward.

    [0069] In the present embodiment, the lengths of the plurality of branch tubes 18a to 18d are approximately the same as one another, and flow path section areas of the plurality of branch tubes 18a to 18d are approximately the same as one another. In other words, the plurality of branch tubes 18a to 18d has approximately the same flow path volume. Therefore, the medical preparation can be further uniformly transferred to the plurality of division bags 20a to 20d.

    [0070] Further, the central lines CL2 of the second branch ports 40a and 42a and the central lines CL3 of the third branch ports 46a and 48a are positioned on the same circumference around the central line CL1 of the first introduction portion 32a. Therefore, the medical preparation introduced into the first introduction portion 32a can be uniformly transferred to the branch tubes 18a to 18d through the second branch ports 40a and 42a and the third branch ports 46a and 48a with a simple configuration.

    [0071] Further, the holding tool 50 includes the connection portion 54 that connects the plurality of division bags 20a to 20d with one another and the mount portion 56 provided to the connection portion 54 and detachably mountable to the head tube 12. Therefore, the inlets 21a to 21d of the plurality of division bags 20a to 20d can be easily held at approximately the same height position by mounting the mount portion 56 to the head tube 12.

    [0072] Still further, the vulnerable portions 58 are formed in the connection portion 54. Therefore, the plurality of division bags 20a to 20d can be separated from one another by breaking the vulnerable portions 58 of the connection portion 54 after the medical preparation in the storage bag 100 is divided into the plurality of division bags 20a to 20d. With the process, the plurality of division bags 20a to 20d can be individually stored and used.

    [0073] In the present embodiment, the medical preparation dividing unit 10 includes the clamp 24 that can block and open the head tube 12. Therefore, the clamp 24 is opened after the plurality of division bags 20a to 20d is held with the holding tool 50, and the transfer process can be started.

    [0074] In the present embodiment, the residual amount transfer process of causing the medical preparation in the head tube 12 to flow downward to the division bags 20a to 20d through the branch portion 16 and the branch tubes 18a to 18d is performed by detaching the mount portion 56 from the head tube 12 after the transfer process. Therefore, the total amount of the medical preparation in the storage bag 100 can be divided into the plurality of division bags 20a to 20d.

    [0075] The medical preparation dividing unit 10 and the medical preparation dividing method according to the present embodiment are not limited to the above examples. The medical preparation dividing unit 10 may be provided with a bottle needle in place of the valve member 14. The vulnerable portions 58 may not be provided in the connection portion 54 of the holding tool 50. Further, in the medical preparation dividing method, the order to perform the holding process, the shape holding process, and the connection process can be arbitrarily changed.

    [0076] The medical preparation dividing unit and the medical preparation dividing method according to the present invention are not limited to the above-described embodiments, and various configurations are employable without departing from the scope of the present invention as defined by the appended claims.


    Claims

    1. A medical preparation dividing unit (10) for dividing a medical preparation stored in a storage member (100) into a plurality of division bags (20a-20d) by head, the medical preparation dividing unit (10) comprising:

    the storage member (100),

    a head tube (12) having one end to which the storage member (100) is connectable;

    a branch portion (16) provided to another end of the head tube (12);

    a plurality of branch tubes (18a-18d) having one ends connected to the branch portion (16);

    the plurality of division bags (20a-20d) having inlets (21a-21d) to which another ends of the branch tubes (18a-18d) are connected, and formed into the same shape and the same size as one another; and

    a holding tool (50) for holding the plurality of division bags (20a-20d) with the inlets (21a-21d) facing downward, below the storage member (100), and for holding the plurality of inlets (21a-21d) at the same height position above the branch portion (16), wherein

    a curved portion (12a) is formed in the head tube (12) on the other end side, an inlet (32a) of the branch portion (16) is arranged above the curved portion (12a), and outlets (40a, 42a) of the branch portion (16) are arranged above the inlet (32a) of the branch portion (16), in a state where the plurality of division bags (20a-20d) is held with the holding tool (50), wherein

    the holding tool (50) includes

    a connection portion (54) that connects the plurality of division bags (20a-20d) with one another, and

    a mount portion (56) provided to the connection portion (54) and detachably mounted to the head tube (12).


     
    2. The medical preparation dividing unit (10) according to claim 1, further comprising:
    a shape holding tool (52) that holds the other end side of the head tube (12) in a curved shape so that the medical preparation is introduced through the head tube (12) into the branch portion (16) from below.
     
    3. The medical preparation dividing unit (10) according to claim 1 or 2, wherein
    flow path volumes of the plurality of branch tubes (20a-20d) are approximately the same as one another.
     
    4. The medical preparation dividing unit (10) according to any one of claims 1 to 3, wherein
    central lines (CL2) of the plurality of outlets (40a, 42a) of the branch portion (16) are positioned on the same circumference around a central line (CL1) of the inlet (32a) of the branch portion (16).
     
    5. The medical preparation dividing unit (10) according to any one of claims 1 to 4, wherein
    a vulnerable portion (58) is formed in the connection portion (54) so that the plurality of division bags (20a-20d) is separable from one another.
     
    6. The medical preparation dividing unit (10) according to any one of claims 1 to 5, further comprising:
    a clamp (24) capable of blocking or opening the head tube (12).
     
    7. A medical preparation dividing method of dividing a medical preparation stored in a storage member (100) into a plurality of division bags (20a-20d) through a head tube (12), a branch portion (16), and a plurality of branch tubes (18a-18d), the method comprising:

    a connection process of connecting the storage member (100) to one end of the head tube (12);

    a holding process of holding, with a holding tool (50), the plurality of division bags (20a-20d) with inlets (21a-21d) facing downward, below the storage member (100) and holding the inlets (21a-21d) of the plurality of bags (20a-20d) at the same height position above the branch portion (16), the plurality of division bags (20a-20d) being formed into the same shape and the same size as one another; and

    a transfer process of transferring the medical preparation to the plurality of division bags (20a-20d) through the branch portion (16) and the branch tubes (18a-18d), by heading the medical preparation from the storage member (100) to the head tube (12) after the holding process, wherein,

    in the transfer process, the medical preparation is transferred to the branch portion (16) through another end side that is curved, of the head tube (12), flows upward in the branch portion (16), and is transferred to the plurality of division bags (20a-20d) through the plurality of branch tubes (18a-18d).


     
    8. The medical preparation dividing method according to claim 7, wherein
    a shape holding process of holding the other end side of the head tube (12) in a curved shape with a shape holding tool (52) is performed before the transfer process so that the medical preparation is introduced through the head tube (12) into the branch portion (16) from below.
     
    9. The medical preparation dividing method according to claim 7 or 8, wherein
    a residual amount transfer process of causing the medical preparation in the head tube (12) to flow downward to the division bags (20a-20d) through the branch portion (16) and the branch tubes (18a-18d) is performed, by canceling the holding of the plurality of division bags (20a-20d) with the holding tool (50) after the transfer process.
     
    10. The medical preparation dividing method according to claim 9, wherein

    the holding tool (50) includes a connection portion (54) that connects the plurality of division bags (20a-20d) with one another, and

    a separation process of separating the plurality of division bags (20a-20d) from one another is performed by cutting the connection portion (54) after the residual amount transfer process.


     


    Ansprüche

    1. Einheit (10) zur Teilung eines medizinischen Präparats zum Teilen eines in einem Aufbewahrungselement (100) gelagerten medizinischen Präparats in eine Vielzahl von Teilungsbeuteln (20a-20d) durch Einbringen, wobei die Einheit (10) zur Teilung eines medizinischen Präparats umfasst:

    das Aufbewahrungselement (100),

    einen Einbringschlauch (12), der ein Ende aufweist, an welches das Aufbewahrungselement (100) anschließbar ist;

    einen Verzweigungsabschnitt (16), der an einem anderen Ende des Einbringschlauchs (12) vorgesehen ist;

    eine Vielzahl von Verzweigungsrohren (18a-18d), die ein Ende aufweisen, welches mit dem Verzweigungsabschnitt (16) verbunden ist;

    wobei die Vielzahl von Teilungsbeuteln (20a-20d) Einlässe (21a-21d) aufweisen, mit denen die anderen Enden der Verzweigungsrohre (18a-18d) verbunden sind, und die in der gleichen Form und der gleichen Größe zueinander ausgeformt sind; und

    ein Haltewerkzeug (50) zum Halten der Vielzahl von Teilungsbeuteln (20a-20d); wobei die Einlässe (21a-21d) nach unten gerichtet sind, unterhalb des Aufbewahrungselements (100), und zum Halten der Vielzahl von Einlässen (21a-21d) in der gleichen Höhenposition oberhalb des Verzweigungsabschnitts (16), wobei

    ein gekrümmter Abschnitt (12a) in dem Kopfschlauch (12) auf der anderen Endseite ausgebildet ist, ein Einlass (32a) des Verzweigungsabschnitts (16) über dem gekrümmten Abschnitt (12a) angeordnet ist und Auslässe (40a, 42a) des Verzweigungsabschnitts (16) über dem Einlass (32a) des Verzweigungsabschnitts (16) in einem Zustand angeordnet sind, in dem die Mehrzahl von Teilungsbeuteln (20a-20d) mit dem Haltewerkzeug (50) gehalten wird, wobei

    das Haltewerkzeug (50) umfasst

    einen Verbindungsabschnitt (54), der die Vielzahl von Teilungsbeuteln (20a-20d) miteinander verbindet, und

    einen Befestigungsabschnitt (56), der an dem Verbindungsabschnitt (54) vorgesehen und abnehmbar an dem Einbringschlauch (12) angebracht ist.


     
    2. Einheit (10) zur Teilung eines medizinischen Präparats nach Anspruch 1, ferner umfassend
    ein Formhaltewerkzeug (52), das die andere Endseite des Kopfrohres (12) in einer gekrümmten Form derart hält, dass das medizinische Präparat durch den Einbringschlauch (12) von unten in den Verzweigungsabschnitt (16) eingeleitet wird.
     
    3. Einheit (10) zur Teilung eines medizinischen Präparats nach Anspruch 1 oder 2, wobei
    die Strömungswegvolumina der Vielzahl von Verzweigungsrohren (20a-20d) annähernd gleich groß untereinander sind.
     
    4. Einheit (10) zur Teilung eines medizinischen Präparats nach einem der Ansprüche 1 bis 3, wobei
    Mittellinien (CL2) der Vielzahl von Auslässen (40a, 42a) des Verzweigungsabschnitts (16) auf dem gleichen Umfang um eine Mittellinie (CL1) des Einlasses (32a) des Verzweigungsabschnitts (16) herum angeordnet sind.
     
    5. Einheit (10) zur Teilung eines medizinischen Präparats nach einem der Ansprüche 1 bis 4, wobei
    ein zerbrechlicher Abschnitt (58) in dem Verbindungsabschnitt (54) ausgebildet ist, sodass die Vielzahl der Teilungsbeutel (20a-20d) voneinander trennbar ist.
     
    6. Einheit (10) zur Teilung eines medizinischen Präparats nach einem der Ansprüche 1 bis 5, ferner umfassend:
    eine Klemme (24), die in der Lage ist, den Einbringschlauch (12) zu blockieren oder zu öffnen.
     
    7. Verfahren zur Teilung eines medizinischen Präparats zum Teilen eines in einem Aufbewahrungselement (100) gelagerten medizinischen Präparats in eine Vielzahl von Teilungsbeuteln (20a-20d) durch einen Einbringschlauch (12), einen Verzweigungsabschnitt (16) und eine Vielzahl von Verzweigungsrohren (18a-18d), wobei das Verfahren umfasst:

    einen Verbindungsvorgang zum Verbinden des Aufbewahrungselements (100) mit einem Ende des Einbringschlauchs (12);

    einen Haltevorgang, bei dem mit einem Haltewerkzeug (50) die Vielzahl von Teilungsbeuteln (20a-20d) mit nach unten gerichteten Einlässen (21a-21d) unterhalb des Aufbewahrungselements (100) gehalten wird und die Einlässe (21a-21d) der Vielzahl von Beuteln (20a-20d) in der gleichen Höhenposition oberhalb des Verzweigungsabschnitts (16) gehalten werden, wobei die Vielzahl von Teilungsbeuteln (20a-20d) in der gleichen Form und der gleichen Größe zueinander ausgeformt sind; und

    einen Übertragungsvorgang zum Übertragen des medizinischen Präparats auf die Vielzahl von Teilungsbeuteln (20a-20d) durch den Verzweigungsabschnitt (16) und die Verzweigungsrohre (18a-18d), indem das medizinische Präparat nach dem Haltevorgang von dem Aufbewahrungselement (100) zu dem Einbringschlauch (12) geleitet wird, wobei,

    bei dem Übertragungsvorgang das medizinische Präparat durch eine weitere, gekrümmte Endseite des Einbringschlauchs (12) in den Verzweigungsabschnitt (16) übertragen wird, in dem Verzweigungsabschnitt (16) nach oben fließt und durch die Vielzahl der Verzweigungsrohre (18a-18d) in die Vielzahl der Teilungsbeutel (20a-20d) übertragen wird.


     
    8. Verfahren zur Teilung eines medizinischen Präparats nach Anspruch 7, wobei
    ein Formhaltevorgang zum Halten der anderen Endseite des Einbringschlauchs (12) in einer gekrümmten Form mit dem Formhaltewerkzeug (52) vor dem Übertragungsvorgang durchgeführt wird, sodass das medizinische Präparat durch den Einbringschlauch (12) von unten in den Verzweigungsabschnitt (16) eingeleitet wird.
     
    9. Verfahren zur Teilung eines medizinischen Präparats nach Anspruch 7 oder 8, wobei
    ein Restmengen-Übertragungsvorgang, der bewirkt, dass das medizinische Präparat in dem Einbringschlauch (12) durch den Verzweigungsabschnitt (16) und die Verzweigungsrohre (18a-18d) nach unten zu den Teilungsbeuteln (20a-20d) fließt, durchgeführt wird, indem das Halten der Vielzahl von Teilungsbeuteln (20a-20d) mit dem Haltewerkzeug (50) nach dem Übertragungsvorgang aufgehoben wird.
     
    10. Verfahren zur Teilung eines medizinischen Präparats nach Anspruch 9, wobei
    das Haltewerkzeug (50) einen Verbindungsabschnitt (54) umfasst, der die Vielzahl von Teilungsbeuteln (20a-20d) miteinander verbindet, und
    einen Trennvorgang zum Trennen der Vielzahl von Teilungsbeuteln (20a-20d) voneinander durch Abschneiden des Verbindungsabschnitts (54) nach dem Restmengen-Übertragungsvorgang durchgeführt wird.
     


    Revendications

    1. Unité de division de préparation médicale (10) pour diviser une préparation médicale contenue dans un élément de stockage (100) en une pluralité de poches de division (20a-20d) par écoulement, l'unité de division de préparation médicale (10) comprenant :

    l'élément de stockage (100),

    un tube d'écoulement (12) ayant une extrémité à laquelle l'élément de stockage (100) peut être raccordé ;

    une partie d'embranchement (16) prévue à une autre extrémité du tube d'écoulement (12) ;

    une pluralité de tubes d'embranchement (18a-18d) ayant des premières extrémités connectées à la partie d'embranchement (16) ;

    la pluralité de poches de division (20a-20d) ayant des entrées (21a-21d) auxquelles les autres extrémités des tubes d'embranchement (18a-18d) sont connectées, et ont la même forme et la même taille les unes que les autres ; et

    un outil de support (50) pour supporter la pluralité de poches de division (20a-20d) avec les entrées (21a-21d) orientées vers le bas, au-dessous de l'élément de stockage (100), et pour supporter la pluralité d'entrées (21a-21d) à la même hauteur au-dessus de la partie d'embranchement (16), où

    une partie courbe (12a) est formée dans le tube d'écoulement (12) du côté de l'autre extrémité, une entrée (32a) de la partie d'embranchement (16) est disposée au-dessus de la partie courbe (12a), et des sorties (40a, 42a) de la partie d'embranchement (16) sont disposées au-dessus de l'entrée (32a) de la partie d'embranchement (16), dans un état où la pluralité de poches de division (20a-20d) est supportée avec l'outil de support (50), où

    l'outil de support (50) comprend

    une partie de connexion (54) qui relie la pluralité de poches de division (20a-20d) les unes aux autres, et

    une partie de montage (56) prévue sur la partie de connexion (54) et montée de façon détachable sur le tube d'écoulement (12).


     
    2. Unité de division de préparation médicale (10) selon la revendication 1, comprenant en outre :
    un outil de maintien de forme (52) qui maintient le côté de l'autre extrémité du tube d'écoulement (12) en une forme courbe de sorte que la préparation médicale est introduite à travers le tube d'écoulement (12) dans la partie d'embranchement (16) par le bas.
     
    3. Unité de division de préparation médicale (10) selon la revendication 1 ou 2, dans laquelle
    des volumes de trajet d'écoulement de la pluralité de tubes d'embranchement (20a-20d) sont approximativement identiques les uns aux autres.
     
    4. Unité de division de préparation médicale (10) selon l'une quelconque des revendications 1 à 3, dans laquelle
    des axes centraux (CL2) de la pluralité de sorties (40a, 42a) de la partie d'embranchement (16) sont positionnés sur la même circonférence autour d'un axe central (CL1) de l'entrée (32a) de la partie d'embranchement (16).
     
    5. Unité de division de préparation médicale (10) selon l'une quelconque des revendications 1 à 4, dans laquelle
    une partie fragile (58) est formée dans la partie de connexion (54) de sorte que la pluralité de poches de division (20a-20d) peuvent être séparées les unes des autres.
     
    6. Unité de division de préparation médicale (10) selon l'une quelconque des revendications 1 à 5, comprenant en outre :
    une pince (24) capable de fermer ou d'ouvrir le tube d'écoulement (12).
     
    7. Procédé de division de préparation médicale pour diviser une préparation médicale contenue dans un élément de stockage (100) en une pluralité de poches de division (20a-20d) par le biais d'un tube d'écoulement (12), d'une partie d'embranchement (16), et d'une pluralité de tubes d'embranchement (18a-18d), le procédé comprenant :

    une opération de connexion consistant à connecter l'élément de stockage (100) à une extrémité du tube d'écoulement (12) ;

    une opération de support consistant à supporter, avec un outil de support (50), la pluralité de poches de division (20a-20d) avec des entrées (21a-21d) orientées vers le bas, au-dessous de l'élément de stockage (100), et supporter les entrées (21a-21d) de la pluralité de poches de division (20a-20d) à la même hauteur au-dessus de la partie d'embranchement (16), la pluralité de poches de division (20a-20d) ayant la même forme et la même taille les unes que les autres ; et

    une opération de transfert consistant à transférer la préparation médicale vers la pluralité de poches de division (20a-20d) par le biais de la partie d'embranchement (16) et des tubes d'embranchement (18a-18d), en faisant s'écouler la préparation médicale depuis l'élément de stockage (100) vers le tube d'écoulement (12) après l'opération de support,

    lors du transfert, la préparation médicale est transférée vers la partie d'embranchement (16) par un côté de l'autre extrémité qui est courbe, du tube d'écoulement (12), s'écoule vers le haut dans la partie d'embranchement (16), et est transférée vers la pluralité de poches de division (20a-20d) à travers la pluralité de tubes d'embranchement (18a-18d).


     
    8. Procédé de division de préparation médicale selon la revendication 7, dans lequel
    une opération de maintien de forme consistant à maintenir le côté de l'autre extrémité du tube d'écoulement (12) en une forme courbe avec un outil de maintien de forme (52) est effectuée avant l'opération de transfert de sorte que la préparation médicale est introduite à travers le tube d'écoulement (12) dans la partie d'embranchement (16) par le bas.
     
    9. Procédé de division de préparation médicale selon la revendication 7 ou 8, dans lequel
    une opération de transfert de quantité résiduelle consistant à amener la préparation médicale présente dans le tube d'écoulement (12) à s'écouler vers le bas vers les poches de division (20a-20d) à travers la partie d'embranchement (16) et les tubes d'embranchement (18a-18d) est effectuée, en annulant le support de la pluralité de poches de division (20a-20d) avec l'outil de support (50) après le transfert.
     
    10. Procédé de division de préparation médicale selon la revendication 9, dans lequel
    l'outil de support (50) comprend une partie de connexion (54) qui relie la pluralité de poches de division (20a-20d) les unes aux autres, et
    une opération de séparation consistant à séparer les poches de division (20a-20d) les unes des autres est effectuée en coupant la partie de connexion (54) après l'opération de transfert de quantité résiduelle.
     




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    REFERENCES CITED IN THE DESCRIPTION



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    Patent documents cited in the description




    Non-patent literature cited in the description