JP2015119919A - Packaging container of medical device and medical device package - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device package, when storing a plurality of components of a medical device in a packaging container facilitating positioning and, in a state of storing the medical device, causing little thermal deformation, even after high-pressure treatment/sterilization treatment.SOLUTION: A bottom wall 5 of a package container includes: a first bottom reinforcement rib 11.1 at a part corresponding to a storage space SPB of a blood collection bag 32; a groove 12M at a position corresponding to a storage space SPS of a blood collection tube holder 30c; a groove 13M at a part corresponding to a storage space SPN of a needle member 31; a fourth bottom reinforcement rib 11.4S2 in a second side part S2 at a part corresponding to a storage space SPNC of a needle member cover; a fourth bottom reinforcement rib 11.4S1 in a first side part S1 at a part corresponding to a storage space SPCL of a clamp; and a side-wall reinforcement rib 8 at a lower side of the storage space SPOC of passage closure means 36.

Description

The present invention relates to a medical device packaging container and a medical device package.
In the present invention, the medical device refers to, for example, a blood collection device, but can be suitably used for a medical device to which substantially the same packaging form as the blood collection device is applied.
Hereinafter, an example of a blood collection device will be described.

A blood collection device is a comprehensive collection of devices (systems) consisting of a blood collection needle, a blood filter, and a plurality of bags, etc. connected to a circuit for collecting blood from a donor (donor) and storing the collected blood as blood for transfusion. Is a common name.
For example, as illustrated in FIG. 28, a blood collection device 30 targeted by the present invention includes a blood collection bag 32, a sampling pouch 30b (sometimes referred to as a “blood collection initial flow removal bag”), a blood collection tube holder 30c, and a blood filter 43. , And a plurality of child bags 45.
More specifically, as shown in FIG. 28, the blood collection device 30 includes a blood collection bag 32, a blood filter 43, a (first) child bag 45, a (second child) bag 45.2 and (third). Child) bag 45.3 (also referred to as a red blood cell storage solution bag).
As described above, such a blood collection device 30 includes a plurality of bags 32, 45, 45.2, 45 connected by a circuit for storing blood collected from a donor (donor) as blood for transfusion. In the present invention, in a broad sense, the blood flow collecting circuit is included in the broad sense, and the sampling pouch 30b is incorporated in a part of the blood collecting circuit. It is used in the meaning of a comprehensive blood collection device 30 constituting a blood collection and storage system.

A blood collection tube T1 is connected upstream of the blood collection bag 32 to form a blood collection circuit. A needle member 31, a branch pipe 34, and a flow path closing means 36 are connected and arranged from the distal end to the middle of the blood collection tube T1.
A sampling pouch 30b is connected to the branch pipe 34 via an initial blood introduction tube T2 (with a clamp 37.1 attached in the middle).

Furthermore, as illustrated in FIG. 28, the flow path closing means 36 is disposed inside the blood collection tube T1 (between the branch tube 34 and the blood collection bag 32). A so-called communication piece is used for the channel closing means 36. The communication piece is configured to close the fluid flow path in the initial setting of the blood circuit, whereby the initial flow of the collected blood is forcibly introduced into the initial flow blood introduction tube T2.
After collecting the initial flow, the liquid channel from the blood collection tube T1 to the blood collection bag 32 is opened by breaking the closure. Then, the T2 tube is closed by the clamp 37.1.
As a specific means for collecting blood (initial flow) into an external container, a blood collection tube holder 30c as shown in FIG. 28 is used. As shown in FIG. 28, a blood collection needle for initial blood (no sign is intentionally written) is attached to the outlet (no sign is intentionally written), and a blood collection tube holder 30c is attached to the outer periphery of the collection needle. . The sampling needle is covered with a sheath (not marked). The blood collection tube holder 30c is means for collecting the blood collected in the sampling pouch 30b into an external container for inspection or the like.
Thus, after collecting blood in the sampling pouch 30b, a vacuum blood collection tube (not shown) is inserted into the blood collection tube holder 30c, and the blood in the sampling pouch 30b is collected in the vacuum blood collection tube.

A blood filter 43 and a (first) child bag 45 are connected downstream of the blood collection bag 32 via a connecting tube T3. The blood filter 43 captures and removes leukocytes that cause side effects such as fever in the blood, and is a non-woven fabric having a fine fiber diameter in a substantially disc-shaped case of a relatively hard resin (housing). Etc. are loaded with a porous fiber material.
In FIG. 28, a plan view of the housing is described, and a state in which the blood inlet i is connected to the tubes T3 and T4 on the back surface of the paper and the blood outlet o on the front surface (front surface) of the paper is described. .

Further, the (first) child bag 45 is connected to the (second) child bag 45.2, (third) child via the connecting tube T5.1, the branch pipe 34.2, and the connecting tubes T5.2, T5.3. The bag 45.3 is connected.
The blood collection bag 32 and the (third) child bag 45.3 (bag containing erythrocyte storage solution) are provided with, for example, ACD solution, CPD solution, CPDA solution for preventing or storing blood coagulation during blood collection or transfusion storage. An anticoagulant such as erythrocyte and a red blood cell preservation solution such as MAP solution are stored.
(As will be described later, it is required that the preservation solution or the like not be evaporated outside the container when stored in a packaging container (particularly in the high-pressure steam sterilization step).)

(Material etc.)
As a material constituting the bags of the sampling pouch 30b and the blood collection bag 32, a soft flexible synthetic resin that is usually used, such as a soft polyolefin-based resin such as soft polyvinyl chloride, soft polyethylene, or soft polypropylene, is used.
On the other hand, as the resin for forming the housing of the blood filter 43 and the blood collection tube holder 30c, for example, a relatively hard resin such as hard polypropylene is used.

The manufactured medical device is stored and transported as a package that is stored in a packaging container that blocks outside air, sealed and sterilized, and is opened and used in a medical institution or the like.
The applicant of the present invention previously described in Patent Document 1 [Patent No. 3601855 (JP-A-8-98874)] a medical instrument [blood collection instrument (including a blood collection bag)] package comprising the following steps. The manufacturing method of was disclosed. The contents are as follows.
<1> a step of sealing the blood collection bag 32 (with a moisture absorbent paper for water droplet absorption) in a transparent synthetic resin packaging bag (polyethylene inner bag, hereinafter referred to as “first packaging container”) having water vapor permeability;
<2> A step of autoclaving the first packaging container,
<3> a step of drying water droplets generated in the first packaging container at a temperature of 20 to 30 ° C. and a treatment time of 1 to 10 days;
<4> A method for producing a package comprising the step of packaging the first packaging container in a water vapor impermeable second packaging container (aluminum sheet outer bag or polyolefin tray). (In the case of multiple wrapping types, wrap with the packaging tray.)

In addition, the present applicant disclosed in Patent Document 2 an invention of a medical device packaging container and a medical device package. (<> Is added to the reference code 2)
The packaging container <1> has a main body <2> and a lid <3>.
The main body <2> has a bottom wall <5> and a side wall <6>. The bottom wall <5> has a side wall <6> standing upright, and the side wall <6> has a flange <7>.
The lid <3> is formed of a multilayer laminate film, and the laminate film can be thermally welded and sealed to the flange <7> of the main body <2> and has a water vapor barrier property. The material can be easily peeled from the flange <7>.
It is a packaging container <1> in which a lid <3> is thermally welded to a flange <7>.

Japanese Patent No. 3601855 (Claims, FIG. 1) International application number PCT / JP2013 / 0667220 (Claims, FIGS. 1 to 7)

The present invention is to solve a new problem found when the method disclosed in Patent Document 1 is actually applied, and the characteristics thereof are remarkably improved with respect to the method of Patent Document 1. A packaging container is provided.
Problems found by the present inventors to be solved are as follows. That is, in the manufacturing method of the package described in Patent Document 1,
<1> Since two types of packaging containers, a bag-shaped first packaging container and a second packaging container for packaging the same, are used, the opening operation of the user's packaging container is complicated.
<2> In a type (specification) in which a plurality of blood collection devices 30 are packaged in a bag-like first packaging container (specification), once the user opens the second packaging container (aluminum outer bag or tray), the blood collection device 30 The moisture-proof performance is reduced. For this reason, after opening the second packaging container, all of the plurality of first packaging bodies must be used as quickly as possible.
<3> After opening the two types of packaging containers (bag-shaped first packaging container and second packaging container for packaging the same), the first packaging container, moisture absorbent paper for absorbing water droplets, the second packaging container, and the packaging tray A variety of wastes such as these are generated, and these are bulky, which is troublesome for the user to dispose of them.
<4> Since an outer bag made of aluminum is normally used as the second packaging container, the contents in the first packaging container cannot be seen. For this reason, the sterilization state of the blood collection device 30 in the first packaging container cannot be confirmed.
There are problems such as.

The present invention is to solve the new problem found when actually applying the packaging container (medical device package) disclosed in Patent Document 2, and thereby, the packaging container (Medical Device) of Patent Document 2 is disclosed. A packaging container having significantly improved characteristics is provided.
Problems found by the present inventors to be solved are as follows. That is, in the packaging container 100 (medical instrument packaging body 120) described in Patent Document 2,
<5> As shown in FIG. 29A, when the blood collection bags 32 and the like are stacked and stored in the storage section, there is a space SP between the uppermost blood collection bag 32 and the lid 3, and At the time of vacuum suction (degassing), the lid 3 was pulled inside (see FIG. 29B), and there was a case in which the container 2 was deformed at the time of high-pressure steam sterilization.
<6> When the automatic packaging machine of the blood collection device 30 is used and stored in the container main body 2, it takes the longest time to align the blood collection needle 31 and delays the packaging process.
<7> Since the blood collection needle 31 is easily in contact with the end of the sampling pouch 30b, the blood collection needle (a metal needle is implanted in the needle base by the heat and pressure during high-pressure steam sterilization, and the sharp tip of the metal needle is covered with a needle cap. The sampling pouch 30b is covered with a coated tamper-proof (the outer periphery of the joint between the needle cap and the needle base is covered with a thin plastic film so that the trace of the needle cap once removed can be confirmed) There is a possibility of sticking to the material (polyvinyl chloride sheet) and breaking.

Therefore, as a result of intensive studies to solve the above problems, the present inventor has reached the following invention. That is,
[1] The present invention is a medical instrument packaging container,
Having a body (2) and a lid (3),
The main body (2) is formed from a heat-resistant material,
The lid (3) can be heat-sealed and sealed to the main body (2), has a water vapor barrier property, and is easily peeled off from the main body (2) when taking out a medical device. Formed from a material that can
The body (2) has a longitudinal (L) direction and a side (S) direction that intersects the longitudinal (L) direction substantially perpendicularly,
The longitudinal (L) direction has a distal (DE) direction and a proximal (PE) direction,
The side (S) direction has a first side (S1) direction and a second side (S2) direction,
The body (2) has a bottom wall (5) and a side wall (6),
The bottom wall (5) erected the side wall (6) from the lower (D) outer peripheral side to the upper (U) side,
The side wall (6) has a proximal side wall (6PE), a distal side wall (6DE), a first side wall (6S1), and a second side wall (6S2),
The side wall (6) has a flange (7) at the top (U),
The flange (7) has a proximal flange (7PE), a distal flange (7DE), a first sidewall flange (7S1), and a second sidewall flange (7S2),
The main body (2) includes a storage space (SPB) for the blood collection bag (32), a storage space (SPS) for the blood collection tube holder (30c), a storage space (SPF) for the blood filter (43), and a needle member (31). Has a storage space (SPN),
Forming a first bottom reinforcing rib (11.1) on the bottom wall (5) corresponding to the storage space (SPB) of the blood collection bag (32);
Forming a groove (12M) in the bottom wall (5) corresponding to the storage space (SPS) of the blood collection tube holder (30c);
A medical device packaging container (1, 1 ′, 1 ″) having a groove (13M) formed in a bottom wall (5) corresponding to a storage space (SPN) of the needle member (31) is provided.

[2] In the present invention, the main body (2) has a storage space (SPNC) for the needle member cover, a storage space (SPCL) for the clamp, and a storage space (SPOC) for the flow path closing means (36).
A second side (S2) side fourth bottom reinforcing rib (11.4S2) is formed on the bottom wall (5) on the first side (S1) side of the storage space (SPNC) of the needle member cover,
A first side (S1) side fourth bottom reinforcing rib (11.4S1) is formed on the bottom wall (5) on the second side (S2) side of the storage space (SPCL) of the clamp,
A medical device packaging container (1, 1 ′, 1 ″) according to [1], in which a side wall reinforcing rib (8) is formed in a lower portion of a storage space (SPOC) of a flow path closing means (36).
[3] In the present invention, the storage space (SPB) of the blood collection bag (32) is arranged from the approximate center position to the base end (PE) side of the main body (2),
The storage space (SPS) of the blood collection tube holder (30c) is arranged on the first side (S1) side on the base end (PE) side of the main body (2),
The storage space (SPF) of the blood filter (43) is disposed on the end (DE) side of the main body (2),
The storage space (SPN) of the needle member (31) is disposed on the first side portion (S1) side from the proximal end (PE) side and substantially in the center [1]. 1 ′, 1 ″).
[4] In the present invention, the storage space (SPNC) of the needle member cover is disposed closer to the end (DE) side on the second side portion (S2) side,
The storage space (SPCL) of the clamp is arranged closer to the end (DE) side on the first side (S1) side,
The medical container packaging container according to [2], wherein the storage space (SPOC) of the flow path closing means (36) is disposed on the second side (S2) side from the approximate center to the proximal end (PE) side. (1, 1 ′, 1 ″).
[5] In the present invention, the bottom wall (5) forms a plurality of bottom reinforcing ribs (11) (11.1, 11.2, 11.3, 11.4),
The first bottom reinforcing rib (11.1) is formed at a location corresponding to the storage space (SPB) of the blood collection bag (32),
The second bottom reinforcing rib (11.2) is formed at a location corresponding to the storage space (SPF) of the blood filter (43),
A plurality of fourth bottom reinforcing ribs (11.4) are provided on the first side (S1) side, the second side (S2) side, and the base end (PE) side of the storage space (SPF) of the blood filter (43). A medical device packaging container (1, 1 ′, 1 ″) according to [1] formed at a place is provided.

[6] In the present invention, the third bottom reinforcing rib (11.3) is formed on the first side (S1) side and the second side (S2) side of the first bottom reinforcing rib (11.1). A medical device packaging container (1) according to [5] is provided.
[7] In the present invention, the lid (3) is formed of a multilayer laminate film, and the laminate film can be thermally welded to the flange (7) of the main body (2) and sealed. It has a barrier property and is formed of a material that can be easily peeled off from the flange (7) of the main body (2).
The medical device packaging container (1, 1 ′, 1 ″) according to [1], in which a lid (3) is thermally welded to the flange (7).
[8] According to the present invention, the lid (3) has a seal layer (3.1), a strength-resistant layer (3.2), and a waterproof layer (3. 3) in order from the lower (D) side to the upper (U) side. 3)
The waterproof layer (3.3) is formed by stacking two layers of a first waterproof layer (3.31) and a second waterproof layer (3.32). 1, 1 ′, 1 ″).
[9] In the present invention, the lid (3) is formed of a material that can be thermally welded to the flange (7) of the main body (2) as the sealing layer (3.1).
The strength layer (3.2) is formed of any one material selected from nylon, polyamide, polyethylene terephthalate,
The medical device packaging container (1, 1) according to [7] or [8], wherein the first waterproof layer (3.31) and the second waterproof layer (3.32) are formed of a plastic material having a vapor deposition layer. ′, 1 ″).
[10] In the present invention, the lid (3) has a handle that is not welded to the flange (7), and the handle includes a proximal end first side handle (3PES1), a proximal end second side portion. The medical device packaging container according to any one of [7] to [9], which is a side handle (3PES2), a terminal first side part handle (3DES1), and a terminal second side part handle (3DES2) (1, 1 ′, 1 ″).
[11] In the present invention, the main body (2) has a ratio of the size in the longitudinal direction (L) to the size in the height (H) with respect to the height (H): 1 in the longitudinal direction (L). : The packaging container (1, 1 ', 1'') of the medical device according to any one of [1] to [10] formed in 10 to 20 is provided.

[12] The present invention seals the medical device (30) in the packaging container (1) of the medical device selected from any one of [1] to [11],
The medical device (30) is a blood collection device (30);
The blood collection device (30) includes a blood collection bag (32), a child bag (45, 45.2, 45.3), a blood filter (43), a blood collection tube holder (30c), and a sampling pouch (30b). And a needle member (31),
In the blood collection bag (32), a child bag (45, 45.2, 45.3) and a sampling pouch (30b) are arranged in an overlapping manner,
Place the blood filter (43), the blood collection tube holder (30c) and the needle member (31) in the blood collection bag (32) so as not to overlap,
Provided is a medical instrument package (20, 20 ′, 20 ″) arranged so that the needle member (31) does not come into contact with the sampling pouch (30b).
[13] In the present invention, the blood collection device (30) includes a needle member cover (31C), a clamp (37.2), and a flow path closing means (36).
The medical device package (20, 20 ′) according to [12], wherein the needle member cover (31C), the clamp (37.2), and the channel closing means (36) are arranged so as not to overlap the blood collection bag (32). , 20 ″).
[14] In the present invention, the blood filter (43) is disposed on the end (DE) side of the main body (2) of the packaging container (1) so as not to overlap the blood collection bag (32),
The blood collection holder (30c) is arranged on the first side (S1) side on the base end (PE) side of the main body (2) of the packaging container (1) so as not to overlap the blood collection bag (32). And
The needle member (31) is disposed on the second side portion (S2) side from the proximal end (PE) side and substantially in the center [13], and the medical device package (20, 20 ′, 20 ″). I will provide a.
[15] In the present invention, the needle member cover (31C) is disposed closer to the end (DE) side on the second side portion (S2) side,
The clamp (37.2) is disposed closer to the end (DE) side on the first side (S1) side,
The flow path blocking means (36) is disposed on the second side (S2) side from the approximate center to the proximal end (DE) side [14], and the medical device package (20, 20 ′, 20 ′) I will provide a.

[16] The present invention seals the medical device (30) in the packaging container (1),
The packaging container (1) has a main body (2) and a lid (3),
The medical device (30) is a blood collection device (30);
The blood collection device (30) includes a blood collection bag (32) and child bags (45, 45.2, 45.3),
When the blood collection bag (32) and the child bag (45, 45.2, 45.3) are stacked and stored in the main body (2) and sealed with the lid (3), the height of the uppermost blood collection bag (32) is increased. The position (BH) is substantially the same height as the height position (FH) of the flange (7H) of the main body (2),
When the lid (3) is sealed, a medical device package (20, 20 ′, 20 ″) is provided in which there is substantially no space between the uppermost blood collection bag (32) and the lid (3). To do.
[17] In the present invention, the bottom wall (11.1BW) of the first bottom reinforcing rib (11.1) of the bottom wall (5) of the main body (2) is in the upper U direction with respect to the bottom surface of the main body (2). A medical device package (20, 20 ′, 20 ″) according to [16] formed at a high position is provided.
[18] In the present invention, the step wall (11F) is formed on the bottom wall (11.1BW), and the bottom wall (11.1BW) at the substantially central position is the highest position in the bottom wall (11.1BW). The medical device packaging body (20, 20 ′, 20 ″) according to [17] formed in 1. is provided.

In the present invention,
(1) As described in Patent Document 1, it is possible to moisture-proof the content liquid in the medical device (blood collection bag of blood collection device) without using the second packaging container (aluminum outer bag or the like), Moreover, since the lid is formed of a transparent multilayer laminate film, the state of the medical instrument inside the package can be confirmed from the outside.
(2) The lid can be easily peeled off from the main body 2, and the lid can be easily opened.
(3) Compared with the invention described in Patent Document 1, the amount of waste / the number of waste in the packaging container can be reduced to two types: a main body and a lid.
(4) Sterilization is possible over the details of the components of the medical device (blood collection bag of the blood collection device).

(5) When the blood collection bags 32 and the like are stacked and stored in the storage space SPB, the space between the uppermost blood collection bag 32 and the lid 2 is substantially or almost eliminated. Since the lid 2 is substantially or hardly withdrawn into the inside, the deformation of the shape in the vicinity of the center of the container 2 during or after the high-pressure steam sterilization process is reduced as compared with Patent Document 2.
(6) Since the needle member (blood collection needle) 31 can be stored in the storage space SPN, the position of the needle member (blood collection needle) 31 when stored in the container 2 using the packaging machine of the medical device (blood collection device) 30 Matching is easy.
(7) Since the needle member (blood collection needle) 31 can be stored in the storage space SPN, a tamper proof coated on the blood collection needle by heat and pressure during high-pressure steam sterilization is used as a sampling pouch as in the packaging container 2 of Patent Document 2. It will not stick to the component 30b (polyvinyl chloride sheet) and break.
(8) Further, since the needle member cover 31C, the clamp 37.2, and the flow path closing means 36 can be stored in the storage spaces SPNC, SPCL, and SPOC so as not to overlap the blood collection bag 32, the medical instrument (blood collection instrument) 30 is packaged. When using the machine, the needle member cover 31C, the clamp 37.2, and the flow path closing means 36 are easily aligned when stored in the container 2.

FIG. 1 is a schematic view (plan view) of a main body of a packaging container of a medical device according to the present invention (first embodiment, hereinafter the same as in FIGS. 2 to 9) viewed from the upper U portion direction. FIG. 2 is a schematic view (overall perspective view) of the main body of the packaging container of the medical device of the present invention as viewed from the terminal DE direction and from the upper U direction / second side S2 direction. FIG. 3 is a schematic view (overall perspective view) of the main body of the medical device packaging container according to the present invention as viewed from the terminal DE direction and from the upper U direction and the first side S1 direction. FIG. 4 is a partially enlarged cross-sectional view of the lid (an example of the layer structure of the multilayer laminate film forming the lid) of the packaging container for the medical device of the present invention and the upper part of the main body. FIG. 5 is a partially enlarged view of FIG. 6 is a cross-sectional view taken along the line AA ′ of FIG. FIG. 7 is a plan view and a side view of the main body of the packaging container of the medical device of the present invention. (A) corresponds to FIG. 1, (B) and (C) correspond to (A) and (B) of FIG. 8 described later, and (D) and (E) correspond to (A) and (E) of FIG. Corresponds to B). FIG. 8 is a side view of the main body of the packaging container of the medical device of the present invention. (A) is a S2 direction side view, (B) is a S1 direction side view. FIG. 9 is a side view of the main body of the packaging container of the medical device of the present invention. (A) is a side view in the base end PE direction, and (B) is a side view in the DE direction. FIG. 10 shows the medical device (blood collection device) packaged in the packaging container of FIG. 1 (medical device packaging body / first embodiment) as viewed from the terminal DE direction and from the upper U direction and the first side S1 direction. It is a schematic diagram (overall perspective view). FIG. 11 is a schematic view (plan view) of the main body of the packaging container of the medical device, which is another embodiment of the present invention (second embodiment, hereinafter the same applies to FIGS. 12 to 17), as viewed from the upper U portion. is there. FIG. 12 is a schematic view (overall perspective view) of a main body of a packaging container for a medical device according to another embodiment of the present invention as viewed from the terminal DE direction and the upper U direction / second side S2 direction. FIG. 13 is a schematic view (overall perspective view) of a main body of a packaging container for a medical device according to another embodiment of the present invention as viewed from the terminal DE direction and the upper U direction / first side S1 direction. 14 is a cross-sectional view taken along the line BB ′ of FIG. FIG. 15 is a plan view and a side view of a main body of a packaging container for a medical device according to another embodiment of the present invention. (A) corresponds to FIG. 11, (B) and (C) correspond to (A) and (B) of FIG. 16 described later, and (D) and (E) correspond to (A) and (E) of FIG. Corresponds to B). FIG. 16 is a side view of a main body of a packaging container for a medical device according to another embodiment of the present invention. (A) is a S2 direction side view, (B) is a S1 direction side view. FIG. 17 is a side view of a main body of a packaging container for a medical device according to another embodiment of the present invention. (A) is a side view in the base end PE direction, and (B) is a side view in the DE direction. FIG. 18 shows the medical device (blood sampling device) packaged in the packaging container of FIG. 11 (medical device package / second embodiment) as viewed from the terminal DE direction and from the upper U direction / second side S2 direction. It is a schematic diagram (overall perspective view). FIG. 19 is a schematic view of the A1-A1 ′ cross section of FIG. FIG. 20 is a schematic view (plan view) of the main body of the packaging container of the medical device, which is another embodiment of the present invention (third embodiment, hereinafter the same as in FIGS. 21 to 26), as viewed from the upper U portion direction. is there. FIG. 21 is a schematic view (overall perspective view) of a main body of a packaging container for a medical device according to another embodiment of the present invention as viewed from the terminal DE direction and the upper U direction / second side S2 direction. FIG. 22 is a schematic view (overall perspective view) of a main body of a packaging container for a medical device according to another embodiment of the present invention as viewed from the terminal DE direction and the upper U direction / first side portion S1 direction. 23 is a cross-sectional view taken along the line CC ′ of FIG. FIG. 24 is a plan view and a side view of a main body of a packaging container for a medical device according to another embodiment of the present invention. (A) corresponds to FIG. 20, (B) and (C) correspond to (A) and (B) of FIG. 25 described later, and (D) and (E) correspond to (A) and (E) of FIG. Corresponds to B). FIG. 25 is a side view of a main body of a packaging container for a medical device according to another embodiment of the present invention. (A) is a S2 direction side view, (B) is a S1 direction side view. FIG. 26 is a side view of the main body of the packaging container for the medical device according to another embodiment of the present invention. (A) is a side view in the base end PE direction, and (B) is a side view in the DE direction. FIG. 27 shows the medical device (blood sampling device) packaged in the packaging container of FIG. 20 (medical device packaging body / third embodiment) as viewed from the terminal DE direction and the upper U direction / second side S2 direction. It is a schematic diagram (overall perspective view). FIG. 28 is an overall view showing a medical instrument (blood sampling instrument). FIG. 29 is a diagram showing the use state of the packaging container described in Patent Document 2. (A) is sectional drawing of the place (medical instrument packaging body) which wrapped. (B) is a cross-sectional view after autoclaving.

[Method of manufacturing medical device package]
Hereinafter, the manufacturing method of the medical device package of the present invention will be described with reference to the drawings. The method for producing a medical device package of the present invention includes <1> medical device storage step, <2> medical device sealing step, <3> high-pressure steam sterilization step,
The above steps <1> to <3> are included.
<1> “Medical device storing step” is a step of storing the medical device 30 in the main body 2 of the packaging container 1. At this time, the atmospheric gas (gas) in the case of performing the storage step becomes a problem as will be described later when the sterilization step is performed.
<2> “Sealing step of medical device” is a step of sealing with the lid 3 while vacuuming the inside of the main body 2 of the packaging container containing the medical device of the above <1>. As will be described later, the sealing is preferably performed by thermal welding (also referred to as heat sealing).
<3> The “high-pressure steam sterilization step” is a step of high-pressure steam sterilization of the sealed packaging container 1 of <2>.

In the present invention, in order to seal the medical device directly to the packaging container 1 and to sterilize by high pressure steam, the lid 3 is a sheet made of a material having a water vapor barrier property (as will be described later).
It has been found that the effect of high-pressure steam sterilization of the packaging container 1 is mainly influenced by the following factors (conditions). That is,
(A): residual amount of gas in the packaging container after vacuum suction of <2>,
(B): High-pressure steam sterilization conditions (temperature, time) of <3> above,
(C): a packaging container, a form of a packaging body to be described later,
(D): It is also influenced by the combination of the conditions (a) to (c).

This point will be described in more detail.
(A) In the present invention, after vacuum suction of the packaging body, high-pressure steam sterilization is performed in a state where the inside of the container is in a reduced pressure state, so the amount of (residual) gas in the packaging container becomes a problem. Here, the “gas” specifically means “air”, but may be an inert gas composed of nitrogen or a rare gas such as helium, neon, argon, krypton, or xenon (hereinafter referred to as “the air”). These broadly defined inert gases are collectively referred to simply as “inert gases”). Alternatively, air may be used instead of air as it is, and an inert gas such as nitrogen and / or argon may be mixed therewith to increase the inertness thereof.
In the case where the “medical instrument housing step” in <1> is performed in air (atmosphere), the gas is “air”. Moreover, when performing in inert gas (atmosphere), such as nitrogen and argon, gas will be "inert gas, such as nitrogen or argon."

In the present invention, (a) “remaining amount of gas in the packaging container after vacuum suction” is a value measured and defined as follows. That is,
(I) The medical device 30 is housed in the packaging container 1 [main body 2] to obtain the medical device package 20, and the lid 3 is sealed to the flange 7 of the main body 2 except for a part thereof. A nozzle connected to a vacuum pump is inserted into the non-sealed portion, the pump is operated, the gas in the packaging container 1 is sucked, and after suction, “the volume of gas remaining in the packaging container 1 [main body 2]” Is the “residual amount of gas”.
Note that the above gas suction method is merely an example, and other equipment such as heat sealing (thermal welding) in a vacuum chamber can also be used.

(Ii) Here, the “residual amount of gas” can be measured, for example, by the water replacement method as follows.
The medical device package 20 prepared in (i) is immersed in a water tank filled with water, and the lid 3 is opened in water. In the graduated cylinder filled with water, the gas ejected from the medical device package 20 is stored and the amount of gas is measured. This is the “remaining amount of gas”.
The smaller the residual amount of gas, the more the sterilization effect can be improved.
For example, the medical device is accommodated in the packaging container 1, and the entire circumference of the flange 7 of the main body 2 is sealed with the lid 3 in a no-load state in which no gas is sucked. Then present in the packaging container to "volume of gas" (referred to as "initial gas volume" V _0.) (Measuring the ejection amount of gas by opening the lid in water in the same manner) to the and 900ml of a vacuum the residual amount of the gas of the packaging container after the suction (and _{V r.)} is, 600 ml (milliliters) or less.
In the above example, more specifically, in the packaging container 1 to be used, the material of the main body 2, the thickness of the container, the degree of formation of the reinforcing rib in the container, the material of the material of the lid 3, the thickness, etc. However, if the “remaining amount of gas” V _r is too small (for example, much lower than about 400 ml), the degree of vacuum in the container increases, and the packaging container 1 (main body 2 and Since the lid 3) is strongly subjected to the external pressure of the high-pressure steam, it tends to be deformed inward, which is not preferable.

Here, assuming that the remaining air amount ratio is α = (V _r / V ₀ ) × 100 (%), when α is 100, it means that the vacuum suction of the air in the package is hardly performed, and α is In the case of 0, it means that the initial gas is completely sucked and removed by vacuum suction. In the above example, since V ₀ = 900 ml, V _r = 600 ml corresponds to α = 67%, and V _r = 400 ml corresponds to α = 44%. The closer α is to zero, the greater the effect of high-pressure steam sterilization. On the other hand, the apparent strength of the container itself decreases, and it tends to deform inward due to the pressure of high-pressure steam.

In summary, (a) the remaining amount of gas in the packaging container after vacuum suction is not limited to the following conditions, but before vacuum suction (in the unloaded state in which no gas is sucked, the main body 2 Assuming that 100: the amount of gas present in the container when the entire circumference of the flange 7 is sealed with the lid 3, the residual air amount ratio α is desirably at least 70 to 40%, preferably 67 to 44%.
Moreover, about the autoclave sterilization conditions (temperature, time) of (b), the temperature is 105 to 125 °, preferably 1
10.degree. C. to 12.sub.1 21.degree. C., pressure 1. 0 kg f / c
m ² to 1. 8 k gf / c
m ² and a treatment time of 10 minutes to 30 minutes are preferable.

[Medical device packaging 20]
Hereinafter, the case where the medical instrument is the blood sampling instrument 30 will be further described as an example.
The medical device packaging body 20 of the present invention is as follows.
In the medical instrument package 20, a medical instrument (blood sampling instrument 30) is housed and sealed in the packaging container 1.
Moreover, the packaging container 1 has the main body 2 which accommodates a medical device, and the lid | cover 3 which seals the said main body. The main body 2 is formed from a material having heat resistance.
The lid 3 can be heat-sealed and sealed to the main body 2 and has moisture resistance against water vapor (water vapor impermeability (also referred to as water vapor barrier property)) and a liquid atmosphere sealed in a medical device. It is made of a material having a function of preventing transpiration into the inside. The water vapor impermeability, as shown in the examples below, is preferably about 0.1 to 0.8 g / m ² · day, preferably about 0.2 to 0.5 g / m ² · day as the water vapor permeability.
Furthermore, when taking out a medical device, it forms from the material which can be peeled from the main body 2 easily.
A detailed embodiment of the packaging container 1 [main body 2 (tray 2)] will be described later.

The blood collection device 30 includes a blood collection bag 32, a child bag 45, and a blood filter 43 as shown in FIG. FIG. 10 shows a state in which a medical instrument such as a blood collection instrument in the present invention is housed in the main body 2 of the packaging container 1 and the lid 3 is attached to form the medical instrument package 20.
In storing the blood collection device 30 in the packaging container 1, first, the blood collection bag 32 and the blood filter 43, the blood collection holder 30 c, the blood collection needle 31, the blood collection needle cover 31 c, and the clamp 37.2 are partitioned in the container 2. Separated and placed at each location. That is, the child bag 45 is placed on the blood collection bag 32 so that the blood collection bag 32 and the blood filter 43 do not overlap with each other in the main body 2 of the packaging container 1. Is preferred.
More specifically, the blood collection device 30 includes a sampling pouch 30b, a blood collection tube holder 30c, a blood collection needle 31, a blood collection needle cover 31c, and a clamp 37.2 in addition to the blood collection bag 32, the child bag 45, and the blood filter 43. It is necessary to pay attention to.

In this case, the storage is arranged in a place where the blood collection bag 32, the child bag 45, and the sampling pouch 30b are overlapped and partitioned.
Thus, basically, the blood collection bag 32 is partitioned and arranged in the main body 2 of the packaging container 1 so that the blood filter 43 and the blood collection tube holder 30c do not overlap.
The blood filter 43 is preferably disposed on the terminal DE side of the main body 2 of the packaging container 1 so as not to overlap the blood collection bag 32.

Further, as shown in FIG. 10, the blood collection tube holder 30c is arranged on the first side S1 side on the proximal end PE side of the main body 2 so as not to overlap the blood collection bag 32.
The blood collection needle 31 is arranged from the side closer to the proximal end PE toward the substantially center on the first side S1 side of the main body 2 so as not to overlap the blood collection bag 32.
The blood collection needle cover 31c is disposed closer to the terminal DE side on the second side S2 side of the main body 2 so as not to overlap with the blood collection bag 32, the blood filter 43, and the clamp 37.2.
The clamp 37.2 is arranged on the first side S1 side of the main body 2 closer to the terminal DE side or the base end PE side so as not to overlap with the blood collection bag 32, the blood filter 43, and the blood collection needle cover 31c.
Although not shown in FIG. 10, the flow path closing means 36 is provided on the upper side of the side reinforcing rib 8, that is, on the second side S <b> 2 side of the main body 2, from the substantially center to the proximal end PE side, It arrange | positions so that it may not overlap with the blood filter 43 and the blood collection needle cover 31c.

In the present invention, the medical device package 20 is obtained by vacuum-suctioning the inside of the packaging container 1 as described above and performing high-pressure steam sterilization processing in a negative pressure state.
The blood collection bag 32 is arranged so as not to overlap the blood filter 43, the blood collection tube holder 30c, the blood collection needle 31, the blood collection needle cover 31c, and the clamp 37.2. Each is directly exposed to a sufficiently high amount of heat.
In other words, a high amount of heat is uniformly transmitted to each component in this way.

In the medical device package of the present invention, the components of the medical device (for example, “blood collection bag” and “blood filter”, “blood collection bag” and “blood collection holder”, “blood collection needle”, and “sampling pouch”) ) And the like are arranged so as not to overlap at all (with a predetermined distance), or the components of the medical device are slightly in contact with each other. It includes both meanings that the end portions may overlap.

[Medical device packaging container 1]
An example of a medical instrument packaging container (hereinafter simply referred to as “packaging container”) that can be suitably used in the medical instrument packaging body of the present invention will be described.
In order to facilitate understanding of the “packaging container” of the present invention, the following definitions are provided.
The reference numerals attached to the claims of the present invention and the explanation of the invention are described in order to facilitate understanding of the packaging container of the present invention, and are intended to identify (limit) the invention by the reference numerals themselves. is not.
For example, as shown in FIG. 1, the packaging container of the present invention has a longitudinal L direction and a side S direction substantially perpendicular to the longitudinal L direction (meaning a “short” direction with respect to the “longitudinal”). Have
In the present invention, “terminal DE (side or direction)” indicates one direction in the longitudinal L direction, and as shown in FIG. 1, means the direction on the side where the blood filter 43 of the blood collection device 30 is disposed (FIG. 1). 1).

In the present invention, “proximal end PE (side or direction)” indicates one direction in the longitudinal L direction, and as shown in FIG. 1, “terminal DE (side or direction)” (where the blood filter is disposed). Means the opposite end, that is, the direction in which the blood collection bag 32 of the blood collection device 30 is arranged.
In the present invention, the “horizontal axis HL (direction)” means, for example, a direction extending in the longitudinal L direction of the main body 2 (see the broken line in the drawing) or a direction extending in the side S direction of the main body 2 (see FIG. 3). Means both). When necessary in the following description, the horizontal axis in the longitudinal L direction is described as “HLL”, and the horizontal axis in the side S direction is described as “HLS”.

In the present invention, the “first side portion S1 (side or direction)” indicates one direction of the side portion S direction, and as shown in FIG. It means the direction (see broken line arrow in the figure). In other words, as shown in FIG. 1, it means the direction of the left end portion of the main body 2 (see the broken line arrow in the figure) when viewed from the base end PE direction.
In the present invention, the “second side portion S2 (side or direction)” indicates one direction of the side portion S direction, and as shown in FIG. It means the direction (see broken line arrow in the figure). In other words, as shown in FIG. 1, it means the direction of the right end portion of the main body 2 (see the broken line arrow in the figure) when viewed from the base end PE direction.

In the present invention, the “upper U (side or direction)” indicates one direction of the side S direction, and as shown in FIG. 3, for example, the upper direction intersects the longitudinal L direction of the horizontal axis HL substantially perpendicularly. (See broken line U (S) in the figure).
In the present invention, the “lower D (side or direction)” indicates one direction of the side S direction, and as shown in FIG. 3, for example, intersects with the longitudinal L direction of the horizontal axis HL substantially perpendicularly. (See broken line D (S) in the figure).

The packaging container 1 of the present invention has a main body 2 and a lid 3.
The main body 2 is for storing and arranging medical instruments, and has a so-called “tray-like” form. Hereinafter, the main body may be simply referred to as “tray”.
The lid 3 is for depressurizing and sealing the inside of the tray containing the medical device, and has a so-called “sheet-like” form, and may be referred to as a “top seal member” or a “seal member”. .

The present invention can be implemented as, for example, the first embodiment, the second embodiment, and the third embodiment depending on the shape of the inner surface of the tray.
The packaging container 1 (the main body 2 or the tray 2) according to the first embodiment of the present invention is illustrated in FIGS. 10 and 19 illustrate a medical device package 20 in which a medical device is stored in the packaging container 1.
The packaging container 1 ′ (main body 2 ′ or tray 2 ′) of the second embodiment is illustrated in FIGS. 11 to 17. FIG. 18 illustrates a medical instrument package 20 ′ in which a medical instrument is stored in a packaging container 1 ′.
The packaging container 1 ″ (main body 2 ″ or tray 2 ″) of the third embodiment is illustrated in FIGS. FIG. 27 illustrates a medical instrument package 20 ″ in which a medical instrument is stored in a packaging container 1 ″.
FIGS. 1 to 3 of the packaging container 1 of the first embodiment correspond to FIGS. 11 to 13 of the packaging container 1 ′ of the second embodiment, and FIGS. 20 to 20 of the packaging container 1 ″ of the third embodiment. 23.
In order to avoid complication of reference numerals for the drawings and the description of the invention, the packaging container 1 ′ of the second embodiment and the packaging container 1 ″ of the third embodiment are common to the packaging container 1 of the first embodiment. Substantially the same members adopt the same reference signs as they are or omit the description of the reference signs. The same applies to the medical device packages 20, 20 ′, 20 ″.

The packaging container 1 ′ of the second embodiment and the packaging container 1 ″ of the third embodiment are only partly different from the packaging container 1 of the first embodiment in the form and the like, but “′”, “ The symbol “′” was added.
In the packaging container 1 ″ of the third embodiment, a new appearance is described with a new code, and the code “″” is not added to the new code.
The packaging container 1 ′ of the second embodiment and the packaging container 1 ″ of the third embodiment are described only for different parts from the packaging container 1 of the first embodiment, and the packaging container 1 of the first embodiment. The description of the same or substantially the same members as those in FIG.
The same applies to the medical device packages 20, 20 ′, 20 ″.
Hereinafter, the packaging container 1 (the main body 2 or the tray 2) (see FIGS. 1 to 10) and the medical device packaging body 20 of the first embodiment will be mainly described.

[Regarding the description of the sign indicating the direction of the position / arrangement of the name of each component]
In the drawings of the present invention and the description of the invention, in the examples of FIGS. 1 to 3, “6” is used as a symbol indicating “side wall”, and “directionality” (of “side wall 6”) is indicated. It was described with a reference numeral.
For example, as illustrated in FIG. 1, the second side wall is described as “6S2”.
For example, as illustrated in FIG. 2, “11.3” indicates a third bottom reinforcing rib. In this regard, reference numeral “11.3S1” in the drawing indicates “third bottom portion” on the “first side S1 side”. “11.3 S2” indicates “third bottom reinforcing rib” on the “second side S2 side”.
In the example of FIGS. 1 to 3, “11 (11.1, 11.2, 11.3, 11.4)” is used as a symbol indicating “bottom reinforcing rib”, and “(bottom reinforcing rib)” is used for this. ()) “Directional” is attached and described.
For example, as illustrated in FIG. 1, the “fourth bottom reinforcing rib 11.4” on the “second side wall S2 side” of the “fourth bottom reinforcing rib 11.4” is described as “11.4S2.”
Further, the description of the side wall 6, the flange 7, the corner 7 </ b> C, the flange folded portion 9, the bottom reinforcing rib 11, and the outer peripheral seal portion 21 is also “the bottom reinforcing rib 11 (11.1, 11.2, 11.3, 11.4”). ) ".
In the names of these “bottom reinforcing ribs” and other components, the signs indicating the direction of the position / arrangement such as “first side S1 side” can be understood as being necessary for understanding the invention. Within the scope, only a part has been described in the drawings and description of the invention.

[Main unit 2 (tray)]
The main body 2 is a tray-like container structure having an open upper surface for placing and storing medical devices, and has at least a bottom wall 5 and a side wall 6 as shown in FIGS. .
The bottom wall (tray bottom) 5 has the side wall 6 erected from the outer peripheral lower portion D side toward the upper U side.
The main body 2 is usually formed of a single layer, but may be formed of a multilayer laminate sheet or the like.
The material of the main body 2 is not particularly limited as long as it is a synthetic resin having heat resistance (not easily discolored or deformed by heat), mechanical strength (rigidity per unit thickness), and good stackability. For example, polypropylene Is preferred. In addition, as a substitute material for polypropylene, a laminate film or sheet of polyvinylidene chloride (PVDC) and polypropylene, for example, polypropylene / polyvinylidene chloride / polypropylene, a laminate film or sheet of polyvinylidene chloride (PVDC) and polyethylene, for example, polyethylene / polychloride A vinylidene / polyethylene laminate film or sheet can also be used.
The “thickness” of the main body 2 (bottom wall 5 and side wall 6) is 500 μm to 1200 μm, preferably 600 to 1000 μm, more preferably about 600 to 900 μm.

The main body 2 of the packaging container 1 of the present invention is preferably formed to be thinner than a typical commercially available product (hereinafter referred to as “A company product”) (“thickness”: 1000 μm). By making the main body (tray) thinner in this way, it is possible to increase the “heat” at the time of high-pressure steam sterilization, that is, the amount of heat exposed to the blood collection device 30 housed inside, and pack a larger amount of heat. Can be applied to the inside of the body.

Moreover, the packaging container 1 of this invention forms height H smaller (shallow depth) compared with a well-known commercially available company A product, and length: longitudinal direction L is larger (longer). ) Is forming.
Longitudinal direction L (longitudinal): about 390 to 410 mm (A company product: 310 mm)
Side direction S (horizontal): about 190 to 210 mm (A company product: 170 mm)
Height H: Lower D to Upper U: Approximately 25 to 35 mm (A company product: 38 mm)
In the packaging container 1 of the present invention, the main body 2 has a ratio of the size in the longitudinal direction L to the size in the height H with respect to the height H: 1: the longitudinal direction L (vertical): approximately 11.1. 14.6 (Company A product: 8.2).

In the above, the values in parentheses are the sizes of known A company products (dimension and L: H ratio).
Thus, since the packaging container 1 of the medical instrument of the present invention is formed longer than the conventional one, the blood collection bag 32, the blood filter 43, and the needle of the blood collection instrument 30 are provided in the packaging container 1 (main body 2). One of the major features is that the member 31, the needle member cover 31C, the clamp 37.2, the flow path closing means 36, and the like can be arranged separately.
Moreover, since the packaging container 1 of the medical instrument of the present invention is formed with a shallow height (depth) H :, the “heat” during the high-pressure steam sterilization process uniformly heats the internal blood collection instrument 30. You can hang it.
The medical device packaging container 1 of the present invention has a main body 2 in which the ratio of the size in the longitudinal: longitudinal direction L to the size in the height (depth) H is set to the height (depth) H: 1. L: 10-20, preferably L: 12-15.

[Lid 3 (top seal)]
The lid 3 is a sheet or film covering the main body, which can be heat-welded to the main body 2 and sealed together with a medical device that houses the inside of the main body and has a water vapor barrier property (also referred to as water vapor impermeable property). In the present invention, the term “water vapor barrier property” is used as a term having a broad meaning meaning both so-called “moisture resistance” and a function of preventing transpiration of a liquid sealed in a medical device.
As a precaution, the “function to prevent liquid transpiration” means that the liquid (blood preservation solution or the like) enclosed in the “blood collection bag 32” of the “blood collection device 30” “transpirations” to the outside. It means performance that can be prevented.
Thus, the lid 3 is made of a material that can be easily peeled off from the main body 2 when taking out the medical instrument. The lid 3 is preferably formed of a multilayer film or a multilayer sheet, and a specific example thereof is a multilayer laminate film (or laminate sheet) or the like (hereinafter simply referred to as “laminate film or the like”).
The lid 3 is made of a multilayer laminate film or the like, and typically, as shown in FIG. 7, for example, the seal layer 3.1 and the strength layer 3.2 are sequentially formed from the lower D side to the upper U side. The waterproof layer 3.3 is laminated.

Although the waterproof layer 3.3 may be a single layer, it is preferable to laminate two layers (a first waterproof layer 3.31 and a second waterproof layer 3.32) as shown in FIG.
The total thickness of the lid 3 made of a multilayer laminate film or the like is basically 10 to 1000 μm, preferably 20 to 250 μm, more preferably 50 μm to 120 μm, and most preferably 70 μm to 100 μm. These laminated films and the like are obtained by laminating and fusing films by an extrusion laminating method, a dry laminating method, a hot melt laminating method, a hot press method or the like. Moreover, it can also laminate | stack by apply | coating an adhesive agent to a film etc.
The lid 3 has a seal layer 3.1 as the lowermost layer. The seal layer 3.1 is formed of a material that can be thermally welded to the flange 7 of the main body 2.

For the sealing layer 3.1 in the lid 3, for example, polyethylene (PE), polypropylene (PP), polystyrene (PS), or other polyolefin-based materials imparted with easy peel properties, among which polyethylene and polypropylene are preferably used. The The polyethylene may be any of low density PE, medium density PE, and line low density PE (LLDPE).
Easy peelability means that the lid 3 is usually welded and fixed to the flange, but it can be easily peeled off by applying a certain external force during use (easy peelability). Depending on the type of mechanism to be imparted, for example, a cohesive peeling type, an interlayer peeling type, an interfacial peeling type, and the like can be mentioned. In the present invention, any of these types can be adopted.

Here, the most typical case of the cohesive peeling type will be described.
Usually, different plastic materials such as polypropylene (PP) and polyethylene (PE), polystyrene (PS) and polyethylene (PE) cannot be heat sealed. Using this property, for example, random PP, PE, PS, and the like are blended (mixed) at a certain ratio.
Considering the case where polypropylene is basically used for both the main body 2 (flange 7) and the seal layer 3.1, when random polypropylene is blended (mixed) with a part of the seal layer 3.1, the seal layer 3 .1 and the upper portion U (flange 7) of the main body 2 are sealed. In that case, the same kind of material (polypropylene parts) is sealed, but the different parts (random polypropylene / seal layer 3.1 and polypropylene / flange 7) are not sealed. In this way, the strength can be achieved so that it can be peeled off by the hand of the operator.

The strength-resistant layer 3.2 is a layer that serves as a base film (base material), and is basically a layer that imparts mechanical strength. For example, a film having a certain degree of rigidity such as nylon (NY), polyamide (PAm), polyethylene terephthalate (PET) or the like is preferably used. These base films may be unstretched or uniaxially or biaxially stretched. Nylon may be any of NY6, NY7, NY9, NY11, NY12, etc., and is not particularly limited.
As the first waterproof layer 3.31 and the second waterproof layer 3.32, a plastic material (plastic film) having a vapor deposition layer (aluminum layer, alumina layer, silica layer, etc.) is preferably used. The first waterproof layer 3.31 and the second waterproof layer 3.32 are formed on a base film such as nylon (polyamide), polypropylene, polyethylene terephthalate, aluminum, alumina (Al ₂ O ₃ ), or silica ( It may be a laminated laminate of vapor-deposited films vapor-deposited by CVD, PVD, sputtering, etc. on a water vapor impermeable layer (water vapor barrier layer) such as SiO ₂ ), silicon nitride (SiN), magnesium oxide (MgO), or the like A film such as a polyvinylidene film (PVdF) or an ethylenetetrafluoroethylene copolymer, which is a fluorine-based resin film having high moisture resistance, can also be used. The thickness of the vapor deposition layer is not particularly limited, but is usually about 1 to 200 nm, preferably 1 to 100 nm, more preferably 2 to 50 nm, and most preferably about 5 to 30 nm.
Thus, as a waterproof layer, vapor deposition polyethylene terephthalate (PET) etc. which formed waterproof layers, such as aluminum, an alumina, and a silica, are suitable. Alternatively, as already mentioned, a low water vapor permeable fluorine-based film, polyvinylidene chloride (PVdC), polyvinylidene fluoride (PVDF), or the like can also be suitably used.

In the method for manufacturing a medical device package of the present invention, the medical device package is vacuum-sealed and sealed, and is sterilized by applying heat. It may be accompanied by deformation such as twisting.
The packaging container 1 of the present invention has a strength of each component in order to prevent the appearance of the medical device package body from being deformed after the production accompanied with high-pressure steam sterilization, to prevent a reduction in commercial value, and to maintain a high appearance. In order to maintain the above and prevent deformation, for example, as shown in FIGS. 1 to 3 and the like, bottom reinforcing ribs 11 (11.1, 11.2, 11.3, 11.4,... ) Is formed. Further, side walls and flange reinforcing ribs 8 are formed on the side walls 6 and the flanges 7.
Further, as shown in FIGS. 5 and 6, a flange turn-back portion 9 is formed on the flange 7.

[Bottom wall 5]
Side wall 6 (6S1, 6S2, 6PE) is erected around bottom wall 5 (the bottom or bottom of the container) in the direction from lower D to upper U (see FIGS. 1 to 3).
The bottom wall 5 is as shown in FIGS. A bottom reinforcing rib 11 is formed. The bottom reinforcing rib 11 is formed in an uneven shape in the illustrations of FIGS. 1 to 3, the storage wall SPB of the blood collection bag 32, the storage space SPF of the blood filter 43, the storage space SPS of the sampling holder 30c, and the storage space of the blood collection needle 31 are provided on the bottom wall 5 of the present invention. The SPN has a storage space SPNC for the blood collection needle cover 31C, a storage space SPCL for the clamp 37.2, and a storage space SPOC for the flow path closing means 36.

More specifically, the first bottom reinforcing rib 11.1 is formed on the bottom wall 5 corresponding to the storage space SPB of the blood collection bag 32.
A groove 12M is formed in the bottom wall 5 corresponding to the storage space SPS of the blood collection tube holder 30c.
Grooves 13M and ribs 13 are formed in the bottom wall 5 corresponding to the storage space SPN of the needle member 31.
A second side S2 side fourth bottom reinforcing rib 11.4S2 is formed on the bottom wall 5 corresponding to the first side S1 side of the storage space SPNC of the needle member cover.
The packaging container 1 ″ (the main body 2 ″ or the tray 2 ″) has a groove 16M and a rib on the bottom wall 5 (upper portion of the flange reinforcing rib 8) corresponding to the side portion of the storage space SPOC of the flow path closing means 36. 16 is formed. (See FIGS. 20-22)
A first side S1 side fourth bottom reinforcing rib 11.4S1 is formed on the bottom wall 5 corresponding to the second side S2 side of the clamp storage space SPCL.

The storage space SPB for the blood bag is arranged near the base PE side from the substantially central position or the substantially central position of the main body 2.
The storage space SPS of the sampling holder 30c is arranged on the first side S1 side on the base end PE side of the main body 2.
The storage space SPF of the blood filter 43 is arranged on the terminal DE side of the main body 2.
The storage space SPN for the blood collection needle 31 is arranged at the center of the first side S1 side from the proximal end PE side.
The storage space SPNC for the needle cover member is disposed closer to the terminal DE side on the second side S2 side.
The clamp storage space SPCL is disposed closer to the terminal DE side on the first side S1 side.
The storage space SPOC of the flow path closing means 36 is arranged on the second side S2 side from the approximate center to the end DE side.

As illustrated in FIGS. 1 to 3, the first bottom reinforcing rib 11.1 is formed by a combination of a substantially rectangular convex portion and a concave portion.
The bottom wall 11.1BW of the first bottom reinforcing rib 11.1 of the bottom wall 5 is so-called “bottom raising” as shown in FIG. 6 (AA ′ cross-sectional view in FIG. 1). “Bottom raising” means that the bottom wall 11.1BW is formed at a position in the upper (top) direction with respect to the bottom surface of the main body 2 (position of the height of the horizontal axis HLS in FIG. 6).

More specifically, the step portions 11F are formed on the bottom wall 11.1BW, and the bottom wall 11.1BW at the substantially central position is arranged at the highest position in the bottom wall 11.1BW.
Thereby, as shown in FIG. 19 (AA ′ cross-sectional view in FIG. 10), the blood collection bag 32, the sampling pouch (blood collection initial flow removal bag) 30b, and the child bags 45 and 45.2.45.3 are stacked. Sometimes, the height position BH of the uppermost blood collection bag 32 is substantially the same as the height position FH of the flange 7.
For this reason, the volume of the upper space SP is reduced, and the lid 3 (film) is
It is not drawn into the container 2.

In the main body 2 of the packaging container 1 (FIGS. 1 to 3), as illustrated in FIGS. 1 to 3, the second bottom reinforcing rib 11.2 includes a plurality (two) of substantially triangular convex portions and substantially the same. It is formed by a combination of square and linear recesses.
Furthermore, the 3rd bottom part reinforcement rib 11.3 is each formed in the 1st side part S1 side and 2nd side part S2 side of the 1st bottom part reinforcement rib 11.1.
As illustrated in FIGS. 1 to 3, the third bottom reinforcing rib 11.3 is formed by alternately forming substantially rectangular convex portions and concave portions.
Furthermore, a plurality of fourth bottom reinforcing ribs 11.4 are formed on the first side S1 side, the second side S2 side, and the base end PE side so as to surround the storage space SPF of the blood filter 43.
Compared with the packaging container 1 of the first embodiment, the main body 2 of the packaging container 1 ′ (FIGS. 11 to 13) of the second embodiment has the first bottom reinforcing rib 11.1 ′ substantially square in the center. The third bottom reinforcing ribs 11.3 (of the packaging container 1 of the first embodiment) are all deleted.

The fourth bottom reinforcing rib 11.4 is, for example, as shown in FIGS.
1st side part 4th bottom part reinforcement rib 11.4S1, 2nd side part side 4th bottom part reinforcement rib 11.4S2
And it has base end side 4th bottom part reinforcement rib 11.4PE.
The 1st side part 4th bottom part reinforcement rib 11.4S1 is further 1st side part side 4th bottom part reinforcement rib (base end side small rib) 11.4S1PE and 1st side part side 4th bottom part reinforcement in upper part U. Ribs (terminal-side small ribs) 11.4S1DE project.
1 to 3, the second side portion-side fourth bottom reinforcing rib 11.4S2 extends from the bottom wall 5 to the first side portion-side fourth bottom reinforcing rib (proximal end side small rib) 11.4S1PE. Is formed in a substantially plate shape so as to rise in the upper U direction from the first side portion side fourth bottom reinforcing rib 11.4S1.
The first side-side fourth bottom reinforcing rib (end-side small rib) 11.4S1DE is formed in a substantially circular shape (column) so as to rise from the first side-side fourth bottom reinforcing rib 11.4S1 in the upper U direction. doing.
More specifically, the second side-side fourth bottom reinforcing rib 11.4S2 is disposed between the storage space SPNC of the blood collection needle cover and the storage space SPF of the blood filter, and the first side-side fourth bottom reinforcing rib. 11.4S1 is arranged between the storage space SPF of the blood filter and the storage space SPCL of the clamp.

When the fourth bottom reinforcing rib 11.4 is formed so as to have a large area and high, a blood bag is formed.
This is not preferable because it becomes an obstacle when stored in the container. In the present invention, the number of formation locations is smaller (three locations) than in Patent Document 2, the area is reduced, and the height is also reduced.
As described above, the stored blood filter 43 is formed to be fixed to the storage space SPF of the blood filter, the blood collection needle cover 31C to the storage space SPNC of the blood collection needle cover, and the clamp 37.2 to the storage space SPCL of the clamp. doing.
In the present invention, the bottom reinforcing ribs 11 (11.1, 11.2, 11.3, 11.4) can, in short, maintain the strength of the bottom wall 5 and the strength of the entire body 2 and prevent deformation. As long as it is a thing, it will not be limited to the form illustrated to FIGS. 1-3, What kind of form may be sufficient.

As illustrated in FIGS. 1 to 3, the bottom wall 5 further has ribs 12 and grooves 12 </ b> M at locations corresponding to the storage spaces SPS of the sampling holder 30 c.
The rib 12 is formed in a so-called substantially U-shape (or also referred to as a substantially C-shape) so as to rise from the bottom wall 5 in the upper U direction. Further, the groove 12M is a groove formed in the approximate center (inside) of the rib 12, and can fix a part of the sampling holder 30c [one end (side, lid, cylinder, etc.)].
In the container main body 2 ″ of the packaging container 1 ″, the bottom wall 5 ″ forms an extension groove 12MS in the groove 12M ″ as illustrated in FIGS. 20 to 22, and the sampling holder 30c has a wrinkle. It can be fixed.

As illustrated in FIG. 1 to FIG. 3, the bottom wall 5 forms a storage space SPN for the needle member 31 (blood sampling needle) on the first side S1 side from the proximal end PE side toward the substantial center. ing.
Grooves 13M and ribs 13 are formed at positions corresponding to the storage space SPN.
The grooves 13M and the ribs 13 are provided side by side (formed substantially in parallel) from the side closer to the base end PE toward the substantial center on the first side S1 side.
The storage space SPN (groove 13M) is formed between the rib 13 and the side wall 6S1 on the first side S1 side.
Thereby, the needle member 31 (blood collection needle) can be stored (dropped) in the storage space SPN.
The storage space SPS of the sampling holder 30c is formed close to the center (center, middle) side, and is formed so as not to overlap the storage space SPN of the needle member 31 (blood sampling needle) in the longitudinal L direction.

[Sidewall 6]
The side wall 6 has a proximal side wall 6PE, a distal side wall 6DE, a first side wall 6S1, and a second side wall 6S2 (see FIGS. 1 to 3, FIG. 9, etc.).
Each side wall 6 is formed as follows in the illustrations of FIGS. 1 to 3, but may have the following shape as long as the object of the present invention can be achieved, and is not limited to the illustrated form.

The proximal side wall 6PE faces the proximal end PE side, the distal side wall 6DE faces the distal DE side, and the first side wall 6S1 and the second side wall 6S2 are on the first side S1 side and the second side S2 side. In this way, each of them rises at a predetermined angle θ.
As illustrated in FIG. 6, the “angle θ” is an angle at which the extension line 6 </ b> EL that rises at a predetermined angle θ intersects the horizontal axis HLS.
The “angle θ” is 60 ° to 85 °. If it exceeds 85 ° too much, it is not preferable because it is inferior in appearance, and if it is too small below 60 °, the contents are difficult to be accommodated and it is difficult to store the contents.

[Flange 7]
The flange 7 includes a proximal side flange 7PE, a distal side flange 7DE, a first side wall flange 7S1, and a second side wall flange 7S2 (see FIGS. 1 to 3).
Each of these flanges 7 is formed as follows in the illustration of FIGS. 1 to 3, but may have the following shape as long as the object of the present invention can be achieved, and is not limited to the illustrated form. .
The proximal flange 7PE is on the proximal PE side, and the distal flange 7DE is on the distal 7DE side.
The first side wall flange 7S1 and the second side wall flange 7S2 are each formed in a substantially flat plate shape toward the first side part S1 side and the second side part S2 side.
Further, the flange 7 has a corner 7C, and includes a proximal first side corner 7CPES1, a proximal second side corner 7CPES2, a distal first side corner 7CDES1, and a distal second side corner 7CDES2. (See FIGS. 1 to 3)

The lid 3 (which forms the multilayer laminate film) is basically heat-welded to the flange 7 of the main body containing the medical device to form the medical device package 20 as illustrated in FIG. In the figure, reference numeral 21 denotes an outer peripheral seal portion (of the lid 3 and the flange 7). Note that high-frequency welding, ultrasonic welding, or welding with an adhesive may be used instead of heat welding.
The outer peripheral seal portion 21 includes a proximal end side seal portion 21PES, a distal end side seal portion 21DES, a first side portion side seal portion 21S1S, and a second side portion side seal portion 21S2S.

Further, with respect to the outer peripheral seal portion 21, 21PES is composed of a base end first side seal portion 21PES1 and a base end second side seal portion 21PES2, and 21DES is a base end first side seal portion 21DES1, a terminal end It has 2 side part side seal part 21DES2.
The lid 3 is not thermally welded at each of the four corners on the base end first side PES1 side, base end second side PES2 side, terminal first side DES1 side, and terminal second side DES2 side. Has a place.
The four corners that are not thermally welded are the proximal first side handle (non-welded portion) 3PES1, the proximal second side handle (non-welded portion) 3PES2, the distal first side handle ( A non-welded portion) 3DES1 and a terminal second side handle (non-welded portion) 3DES2 are formed.
The non-welded part formed as described above functions as a handle. Thus, the handle comprising the non-welded portion can be easily held from any end (the terminal DE side, the base PE side, the first side S1 side, the second side S2 side) of the main body 2, and the lid 3 Can be easily peeled off.

[Sidewall rib 8]
The side wall ribs 8 are arranged from the base end PE side of the first side part S1 of the side wall 6 to a position beyond the approximate center of the first side part S1.
[Flange turning part 9]
For example, as shown in FIGS. 1 to 3 and 6, the flange 7 further includes a flange turn-back portion 9.
The flange folding portion 9 includes a proximal side flange folding portion 9PE, a distal side flange folding portion 9DE, a first side wall side flange folding portion 9S1, and a second side wall side flange folding portion 9S2.
The proximal side flange folded part 9PE, the distal side flange folded part 9DE, the first sidewall side flange folded part 9S1, and the second sidewall side flange folded part 9S2 are folded toward the lower D direction.

In the main body 2 ″ of the packaging container 1 ″ of the third embodiment (see FIGS. 20 to 27), the packaging container 1 of the first embodiment and the packaging container 1 ′ of the second embodiment are as follows. The point is different.
(1) A plurality of small ribs 11T project in the lower D direction along the longitudinal L direction at substantially the center of the first bottom reinforcing rib 11.1 '' (of the bottom wall 5). The plurality of small ribs 11T are formed in a so-called “substantially cylindrical shape”. (See FIGS. 20 to 23. In FIGS. 20 to 22, an arrow is attached to the position of the “substantially circular hole” on the upper U side where the small rib 11T is formed.)
By forming the plurality of small ribs 11T in this way, the weight of the blood collection bag 32 and the like can be supported.
(2) An extension groove 12MS is further formed in the groove 12M ″ (on the bottom wall 5). By forming the extension groove 12MS in this way, when the sampling holder 30c is mounted in the groove 12M ″, the hook of the sampling holder 30c is fixed to the extension groove 12MS, and the sampling holder 30c can be fixed so as not to move. I can do it.
(3) Grooves 16M and ribs 16 are formed so that a three-dimensional shape can be clearly grasped (from the upper part of the side wall reinforcing ribs 8) from the approximate center on the second side S2 side of the main body 2 ″ to the base end PE side. ing. By the groove 16M and the rib 16, the flow path closing means (communication piece) 36 [the inner cover has a portion to be cut and is attached so as to cover the outside of the cut portion (so-called “substantially tubular” form) Storage space SPOC is formed. Thereby, the installation of the flow path closing means (communication piece) 36 can be improved.

(4) A groove 15M is formed (in the bottom wall 5) from the approximate center on the second side S2 side of the main body 2 ″ to the terminal DE side. By forming the groove 15M, the outlet o of the blood filter 43 can be attached to the groove 15M, and the blood filter 43 can be easily fitted and fixed to the storage space SPF.
(5) A groove 11.4 is formed in the base end side fourth bottom reinforcing rib 11.4PE (of the bottom wall 5).
By forming the groove 11.4, the groove 11.4 absorbs and relaxes the load of sterilization pressure or product weight, and prevents the deformation of the second bottom reinforcing rib 11.2 (floating to the upper U side). I am doing so.
(6) A plurality of small ribs 17S1 are formed between the upper portion U of the first side wall 6S1 and the second side portion S2 side of the first side wall flange 7S1.
A plurality of small ribs 17S2 are formed between the upper portion U of the second side wall 6S2 and the first side portion S1 side of the second side wall flange 7S2.
By forming the plurality of small ribs 17S1 and 17S2, the expansion of the flange (the first side wall flange 7S1 and the second side wall flange 7S2) (deformation in the direction of the first side portion S1 and the second side portion S2) is suppressed. Like to do.
(7) 1st side 4th bottom reinforcement rib 11.4S1 (of the bottom wall 5) 1st side 4th bottom reinforcement rib (base end side small rib) 11.4S1PE, 1st side 4 Bottom part reinforcing rib (end side small rib) 11.4S1DE is deleted.

The packaging container in the present invention, particularly the main body thereof, can be manufactured by a normal thermoplastic molding technique. For example, it can be produced by compression molding, transfer molding, injection molding, blow molding, vacuum molding, pressure molding, press molding, cast molding, and the like.
In addition to blood collection devices, medical devices to which the present invention can be applied include angiographic catheters, balloon catheters, veins or arterial indwelling catheters, but are not limited thereto.

[Method of manufacturing medical device (blood sampling device) package]
An embodiment of a method for producing a medical instrument (blood sampling instrument) package of the present invention will be described.
In this embodiment, the lid 3 was a four-layer laminate film [manufactured by Maruto Sangyo Co., Ltd.] as shown in FIG. The main body 2 was as shown in FIG.

Content of the four-layer laminate film constituting the lid 3 (i) Overall thickness: 99 μm,
(Ii) Thickness of each layer: seal layer 3.1 (PE / 50 μm) / strength layer 3.2 (NY25 / 25 μm) / first waterproof layer 3.31 (alumina 10 nm deposition PET / 12 μm) / second waterproof layer 3.32 (Alumina 10 nm deposition PET / 12 μm)
(Iii) Water vapor permeability: 0.20 g / m ² · day,
(Iv) Gas permeability (oxygen): 0.15 g / m ² · day · atm,
(V) Gas permeability (carbon dioxide): 0.64 g / m ² · day · atm.
Contents of main body 2 ,
(I) A single layer made of polypropylene (manufactured by RP TOPLA, trade name: NOAEXAS-NE-P) was used.
(Ii) Overall thickness: 600 μm
Blood collection instrument 30
The thing of the form shown in FIG. 20 was used.

As described below, the blood collection device 30 was housed in the main body 2, sealed, and autoclaved to produce a package.
<1> (Storing process of blood collection device 30 in packaging container 1):
On the lower part D side of the blood collection bag 32, the child bags 45, 45.2, 45.3 and the sampling pouch 30b are arranged so as to overlap each other.
The blood collection tube holder 30c and the blood filter 43 are arranged so as not to overlap the blood collection bag 32.
That is, the blood filter 43 is arranged on the terminal DE side of the main body 2.
The blood collection tube holder 30c is disposed on the first side S1 side on the proximal end PE side of the main body 2.

<2> (Vacuum suction of packaging container 1 and sealing step of blood collection device):
The inside of the packaging container 1 was vacuum-sucked so that the air remaining amount (V _r ) in the packaging container 1 was 500 ml, and the lid 3 was thermally welded to the main body 2 and sealed. (The initial gas residual amount V ₀ was 1000 ml. Therefore, the residual air amount ratio α = (V _r / V ₀ ) is 50%.)
Using a heat sealing machine (trade name: heater press machine, manufactured by MI Seal Co., Ltd.) at a temperature of 170 ° C., on the upper U side of the main body 2, the base PE side, the terminal DE side, the first side S1 side, It welded along the flange 7 formed in the 2nd side part S2 side. The welding strength was about 20N.
<3> (High-pressure steam sterilization process):
The packaging container 1 (medical device packaging 21) in which the blood collection device 30 was sealed was subjected to high-pressure steam sterilization at a pressure of 0.92 kg / cm ² , a temperature of 121 ° C., and a treatment time of 12 minutes.

[Appearance of packaging container for medical equipment after high-pressure steam sterilization (medical equipment packaging)]
After confirming the appearance of the packaging container 1 (medical instrument packaging body 21) after the high-pressure steam sterilization treatment,
The deformation as shown in FIG. 21B (recess in the center) was not observed.

[Opening of medical device packaging container (medical device packaging) and removal of medical device]
<1>: The end of the lid 3 was grasped with a finger and pulled up by applying a force from the flange 7 of the main body 2 to the upper U side.
<2>: The lid 3 could be peeled off from the flange 7 of the main body 2 with an appropriate strength.
<3>: The blood collection device 30 was taken out from the packaging container 1 (medical device packaging body 21).
<4>: The packaging container 1 (medical instrument packaging body 21) to be discarded was only the two parts of the lid 3 and the main body 2.

As described above, in the present invention, since the blood collection device 30 is individually packaged in the packaging container 1 and sterilized in the packaging container 1, the user can easily put the film in an aseptic state. Can be opened and blood collection device can be used.
The medical device package of the present invention obtained as described above can be sterilized over the details of the packaged blood collection device 30.
In the present invention, the amount of heat set at the time of high-pressure steam sterilization can penetrate into the packaging container 1 as uniformly as possible by the form of the packaging container 1 and the packaging body 20 and the manufacturing method of the packaging body 20.
For this reason, the blood collection instrument 30 can be sterilized reliably.
In addition, according to the present invention, it is possible to prevent moisture in the medical device (blood collection bag of the blood collection device) from using the second packaging container (such as an aluminum outer bag) as in the prior art. Moreover, since the lid is formed of a transparent multilayer laminate film, the state of the medical device inside the package can be confirmed from the outside.

1, 1 ', 1''Packaging container L Longitudinal direction HL Horizontal axis HLL Longitudinal horizontal axis HLS Side horizontal axis PE Base end DE Terminal S Side direction S1 First side S2 Second side U Upper D Lower 2, 2 ′, 2 ″ body (tray)
3 Lid (top seal member)
3.1 Seal layer 3.2 Strength layer 3.3 Waterproof layer 3.31 First waterproof layer 3.32 Second waterproof layer 3PES1 Base end first side handle (non-welded portion)
3PES2 Base end second side handle (non-welded part)
3DES1 Terminal 1st side handle (non-welded part)
3DES2 Terminal second side handle (non-welded part)
5 Bottom wall 6 Side wall 6PE Base end side wall 6DE End side wall 6S1 First side wall 6S2 Second side wall 7 Flange 7PE Base end side flange 7DE End side flange 7S1 First side wall flange 7S2 Second side wall flange 7C Corner 7CPES1 Base end first Side corner 7CPES2 Base end second side corner 7CDES1 Terminal first side corner 7CDES2 Terminal second side corner 8 Side wall reinforcing rib 9 Flange return 9PE Base end flange return 9DE End flange return 9S1 1st side wall side flange folding part 9S2 2nd side wall side flange folding part 11 Bottom part reinforcement rib 11F Step part 11.1 1st bottom part reinforcement rib 11.1 '1st bottom part reinforcement rib 11.1''1st bottom part reinforcement rib 11.1T (first bottom reinforcing rib) small rib 11.2 second bottom reinforcing rib 11.3 third bottom reinforcing rib 11 3S1 1st side part 3rd bottom part reinforcement rib 11.3S2 2nd side part side 3rd bottom part reinforcement rib 11.4 4th bottom part reinforcement rib 11.4M (4th bottom part reinforcement rib) Groove part 11.4S1 1st side part Side fourth bottom reinforcing rib 11.4S1PE First side side fourth bottom reinforcing rib (base end side small rib)
11.4S1DE 1st side part 4th bottom part reinforcement rib (terminal side small rib)
11.4S2 Second side side fourth bottom reinforcing rib 11.4PE Base end side fourth bottom reinforcing rib 12 Rib 12M Groove 12M ″ Groove 12MS Extension groove
13 Ribs
13M groove 15M groove 16 rib 16M groove 17 small rib SPB Blood collection bag storage space SPS Sampling holder storage space SPF Blood filter storage space SPN Needle member (blood collection needle) storage space SPNC Needle member (blood collection needle) cover storage space SPOC storage space SPCL flow passage means (communication piece) storage space SPCL clamp (37.2) storage space 20 medical instrument packaging 21 outer peripheral seal 21 PES proximal seal 21 DES distal seal 21 S 1 S first side seal 21S2S Second side portion seal portion 21PES1 Base end first side portion seal portion 21PES2 Base end second side portion seal portion 21DES1 End base end first side portion seal portion 21DES2 Terminal first side portion seal portion 30 Blood sampling Equipment (medical equipment)
30b Sampling pouch (initial blood removal bag)
30c Blood collection tube holder 31 Needle member (blood collection needle)
31c Needle member cover (blood collection needle cover)
32 Blood collection bag 34, 34.2 Branch pipe 36 Channel block means (communication piece)
37.1, 37.2 Clamp 43 Blood filter 45, 45.2.45.3 Child bag T tube T1 Blood collection tube T2 Primary blood tube T3, T4, T5.1, T5.2, T5.3 Connection tube

Claims (18)

A packaging container for medical equipment,
Having a body (2) and a lid (3),
The main body (2) is formed from a heat-resistant material,
The lid (3) can be heat-sealed and sealed to the main body (2), has a water vapor barrier property, and is easily peeled off from the main body (2) when taking out a medical device. Formed from a material that can
The body (2) has a longitudinal (L) direction and a side (S) direction that intersects the longitudinal (L) direction substantially perpendicularly,
The longitudinal (L) direction has a distal (DE) direction and a proximal (PE) direction,
The side (S) direction has a first side (S1) direction and a second side (S2) direction,
The body (2) has a bottom wall (5) and a side wall (6),
The bottom wall (5) erected the side wall (6) from the lower (D) outer peripheral side to the upper (U) side,
The side wall (6) has a proximal side wall (6PE), a distal side wall (6DE), a first side wall (6S1), and a second side wall (6S2),
The side wall (6) has a flange (7) at the top (U),
The flange (7) has a proximal flange (7PE), a distal flange (7DE), a first sidewall flange (7S1), and a second sidewall flange (7S2),
The main body (2) includes a storage space (SPB) for the blood collection bag (32), a storage space (SPS) for the blood collection tube holder (30c), a storage space (SPF) for the blood filter (43), and a needle member (31). Has a storage space (SPN),
Forming a first bottom reinforcing rib (11.1) on the bottom wall (5) corresponding to the storage space (SPB) of the blood collection bag (32);
Forming a groove (12M) in the bottom wall (5) corresponding to the storage space (SPS) of the blood collection tube holder (30c);
A groove (13M) is formed in the bottom wall (5) corresponding to the storage space (SPN) of the needle member (31).
A packaging container (1, 1 ′, 1 ″) for medical equipment, characterized by that. The main body (2) has a storage space (SPNC) for a needle member cover, a storage space (SPCL) for a clamp, and a storage space (SPOC) for a flow path closing means (36).
A second side (S2) side fourth bottom reinforcing rib (11.4S2) is formed on the bottom wall (5) on the first side (S1) side of the storage space (SPNC) of the needle member cover,
A first side (S1) side fourth bottom reinforcing rib (11.4S1) is formed on the bottom wall (5) on the second side (S2) side of the storage space (SPCL) of the clamp,
Side wall reinforcing ribs (8) are formed in the lower part of the storage space (SPOC) of the flow path closing means (36).
The medical instrument packaging container (1, 1 ', 1'') according to claim 1. The storage space (SPB) of the blood collection bag (32) is disposed closer to the base end (PE) side from a substantially central position or a substantially central position of the main body (2),
The storage space (SPS) of the blood collection tube holder (30c) is arranged on the first side (S1) side on the base end (PE) side of the main body (2),
The storage space (SPF) of the blood filter (43) is disposed on the end (DE) side of the main body (2),
The medical space according to claim 1, wherein the storage space (SPN) of the needle member (31) is arranged at the first side portion (S1) side from the proximal end (PE) side to the approximate center. Instrument packaging container (1, 1 ', 1 "). The storage space (SPNC) of the needle member cover is arranged closer to the end (DE) side on the second side (S2) side,
The storage space (SPCL) of the clamp is arranged closer to the end (DE) side on the first side (S1) side,
The storage space (SPOC) of the flow path closing means (36) is disposed on the second side portion (S2) side from the approximate center to the base end (PE) side.
The medical instrument packaging container (1, 1 ', 1'') according to claim 2. The bottom wall (5) forms a plurality of bottom reinforcing ribs (11) (11.1, 11.2, 11.3, 11.4),
The first bottom reinforcing rib (11.1) is formed at a location corresponding to the storage space (SPB) of the blood collection bag (32),
The second bottom reinforcing rib (11.2) is formed at a location corresponding to the storage space (SPF) of the blood filter (43),
A plurality of fourth bottom reinforcing ribs (11.4) are provided on the first side (S1) side, the second side (S2) side, and the base end (PE) side of the storage space (SPF) of the blood filter (43). The place formed,
The medical instrument packaging container (1, 1 ', 1'') according to claim 1. The third bottom reinforcing rib (11.3) is formed on the first side (S1) side and the second side (S2) side of the first bottom reinforcing rib (11.1). Item 6. A medical device packaging container according to Item 5. The lid (3) is formed of a multilayer laminate film, the laminate film can be heat-sealed to the flange (7) of the main body (2) and sealed, and has a water vapor barrier property. Formed of a material that can be easily peeled from the flange (7) of the body (2),
The medical device packaging container (1, 1 ', 1 ") according to claim 1, wherein the lid (3) is thermally welded to the flange (7). The lid (3) is formed by laminating a seal layer (3.1), a strength-resistant layer (3.2), and a waterproof layer (3.3) sequentially from the lower (D) side to the upper (U) side,
The waterproof layer (3.3) is formed by laminating two layers of a first waterproof layer (3.31) and a second waterproof layer (3.32). Medical instrument packaging container (1, 1 ', 1 "). The lid (3) is formed of a material that can be thermally welded to the flange (7) of the main body (2) as the sealing layer (3.1),
The strength layer (3.2) is formed of any one material selected from nylon, polyamide, polyethylene terephthalate,
The first waterproof layer (3.31) and the second waterproof layer (3.32) were formed of a plastic material having a vapor deposition layer.
A packaging container (1, 1 ', 1'') for a medical instrument according to claim 7 or claim 8, The lid (3) has a handle that is not welded to the flange (7). The handle includes a proximal first side handle (3PES1), a proximal second side handle (3PES2), and a distal end. The medical device packaging container according to any one of claims 7 to 9, which is a first side handle (3DES1) and a terminal second side handle (3DES2). 1, 1 ′, 1 ″). The main body (2) has a ratio between the size in the longitudinal direction (L) and the size in the height (H),
It forms in the longitudinal direction (L): 10-20 with respect to height (H): 1, The packaging container (1) of the medical instrument of any one of Claims 1-10 characterized by the above-mentioned. 1, 1 ′, 1 ″). Sealing the medical device (30) in the packaging container (1) of the medical device selected from any one of claims 1 to 11;
The medical device (30) is a blood collection device (30);
The blood collection device (30) includes a blood collection bag (32), a child bag (45, 45.2, 45.3), a blood filter (43), a blood collection tube holder (30c), and a sampling pouch (30b). And a needle member (31),
In the blood collection bag (32), a child bag (45, 45.2, 45.3) and a sampling pouch (30b) are arranged in an overlapping manner,
Place the blood filter (43), the blood collection tube holder (30c) and the needle member (31) in the blood collection bag (32) so as not to overlap,
The needle member (31) was arranged so as not to contact the sampling pouch (30b),
A medical device package (20, 20 ', 20'') characterized by that. The blood collection device (30) has a needle member cover (31C), a clamp (37.2), and a flow path closing means (36).
The medical device package according to claim 12, wherein the needle member cover (31C), the clamp (37.2), and the flow path closing means (36) are arranged so as not to overlap the blood collection bag (32). Body (20, 20 ', 20 "). The blood filter (43) is arranged on the end (DE) side of the main body (2) of the packaging container (1) so as not to overlap the blood collection bag (32),
The blood collection holder (30c) is arranged on the first side (S1) side on the base end (PE) side of the main body (2) of the packaging container (1) so as not to overlap the blood collection bag (32). And
The needle member (31) is arranged on the second side portion (S2) side from the proximal end (PE) side to the approximate center,
14. The medical device package (20, 20 ′, 20 ″) according to claim 13. The needle member cover (31C) is disposed closer to the end (DE) side on the second side (S2) side,
The clamp (37.2) is disposed closer to the end (DE) side on the first side (S1) side,
The flow path closing means (36) is arranged on the second side (S2) side from the approximate center to the base end (DE) side,
The medical device package (20, 20 ', 20 ") according to claim 14, characterized in that. Sealing the medical device (30) in the packaging container (1);
The packaging container (1) has a main body (2) and a lid (3),
The medical device (30) is a blood collection device (30);
The blood collection device (30) includes a blood collection bag (32) and child bags (45, 45.2, 45.3),
When the blood collection bag (32) and the child bag (45, 45.2, 45.3) are stacked and stored in the main body (2) and sealed with the lid (3), the height of the uppermost blood collection bag (32) is increased. The position (BH) is substantially the same height as the height position (FH) of the flange (7H) of the main body (2),
When the lid (3) is sealed, there is substantially no space between the uppermost blood collection bag (32) and the lid (3), the medical device package (20, 20 ', 20 ″). The bottom wall (11.1BW) of the first bottom reinforcing rib (11.1) of the bottom wall (5) of the main body (2) is formed at a position higher in the upper U direction than the bottom surface of the main body (2). The medical device package (20, 20 ', 20 ") according to claim 16, characterized in that: A step portion (11F) is formed on the bottom wall (11.1BW), and the bottom wall (11.1BW) at a substantially central position is formed at the highest position in the bottom wall (11.1BW). The medical instrument packaging body (20, 20 ', 20' ') according to claim 17.