JP2001224697A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent erroneous connection of a tube and attempt improvement of safety. SOLUTION: The medical device is called the so-called multiple bag which has the first, second, and third containers, and tubes 4 and 5 connecting these containers and which can be used in virus inactivation treatment of blood or blood components. The tubes 4 and 5 of this medical device has a connection preventing means preventing connection to other tube 106 by a tube aseptic connecting device 100. That is, by coating the tubes 4 and 5 with a coating member 81, a large diameter portion 8 of for example, the order of 4.6 to 5.6 mm in outer diameter is formed, the presence of which does not permit insertion into the grooves 104 and 105 of the holders 101a and 101b of the tube aseptic connecting device 100.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device formed by connecting a plurality of containers such as a multiple bag with a tube.

[0002]

2. Description of the Related Art Diseases such as AIDS, hepatitis B, hepatitis C, adult T-cell leukemia, varicella-zoster, etc. are known as AIDS virus, hepatitis B virus, hepatitis C virus, human T-cell leukemia virus, respectively. It is known that the virus is brought about by the Lupes virus and the like, and various diseases caused by such a virus have recently become a major social problem.

[0003] Prevention of viral infection, which is one of the important measures for preventing diseases caused by viruses, is also strongly demanded for blood products for blood transfusion. Therefore, when manufacturing blood products for transfusion, not only elimination of inappropriate blood by screening, but also virus removal and inactivation of blood from blood have become important issues, and research and development for that purpose have been conducted. I have.

[0004] As a method for removing or inactivating a virus, the following method is conventionally known.

[0005] A method of separating and removing virus particles using a filter (Japanese Patent Laid-Open No. 2-167232).

[0006] A method of biochemically adsorbing and removing a virus by using a receptor on the surface of a virus target cell or the cell itself (US Pat. No. 4,869,826).

A method of inactivating using a virus inactivating agent.

Here, the above-mentioned method includes a method of inactivating with β-propiolactone which is a type of inactivating agent interacting with viral nucleic acid (AM Prince, W. Steph).
an, B. Brotman, "β-Propiolactone / Ultraviolet Irr
adiation: A Review of its Effectiveness for Inact
ivation of Viruses in Blood Derivatives ", Rev. Infe
ct. Dis., (1983), 5, 92-107), but it is not widely used due to the danger of drugs used to inactivate viruses.
After the inactivation treatment, it is often necessary to separate the used drug and virus debris from the liquid to be treated (Table 8).
No. 508048).

In such a blood treatment, a multiple container (multiple bag) in which a plurality of containers are connected by a tube is used, and whole blood or a blood product is transferred between the containers in a predetermined order, and mixed with a drug solution. , An inactivation process, a drug separation process, and the like.

[0010] In particular, such a series of operations performed for each sample is mostly manual, and therefore has the following drawbacks.

For example, a high unit preparation may be divided as needed to prepare a small unit preparation. In this case, a series of inactivation treatment steps is completed in a final container.
Tube aseptic connecting device (for example, Terumo TSCD
Using SC-201A), a tube communicating with the small-unit preparation container is connected, and the tube is subdivided through the tube.

However, due to an error, the possibility of connecting a tube communicating with the small-unit preparation container to the preparation container in the process of the inactivation process cannot be denied. When such an error occurs, an unnecessary drug remains or a necessary drug is missing in the subdivided preparation, and there is a concern about danger when the drug is used clinically.

[0013] Such misconnection of the tubes is not limited to the virus inactivation treatment of blood products, but may occur at various medical sites.

[0014]

SUMMARY OF THE INVENTION An object of the present invention is to provide a medical device which can prevent erroneous connection of tubes and improve safety in, for example, the virus inactivation treatment of blood products as described above. To provide.

[0015]

This and other objects are achieved by the present invention which is defined below as (1) to (13).

(1) A medical device having a first container, a second container, and a tube connecting the first container and the second container, wherein the tube is connected by a tube aseptic connection. A medical device comprising a connection preventing means for preventing a device from being connected to another tube.

(2) The connection preventing means forms a large-diameter portion with an increased outer diameter of the tube, thereby making it impossible to load the tube aseptic connection device into the tube holding portion. The medical device according to 1).

(3) The outer diameter of the large diameter portion is 4.6 to
The medical device according to the above (2), which is 5.6 mm.

(4) The medical device according to the above (2) or (3), wherein the large diameter portion is formed by attaching a covering member.

(5) The medical device according to any one of (2) to (4), wherein the large-diameter portion is formed continuously over substantially the entire length of the tube.

(6) The medical device according to any one of (2) to (4), wherein the large-diameter portion is formed intermittently along a longitudinal direction of the tube.

(7) The length of the intermittent portion of the large diameter portion is 4
The medical device according to the above (6), which is not more than 5 mm.

(8) The medical device according to any one of (1) to (7), wherein the tube has a portion that can be sealed and cut by a tube sealer.

(9) The medical device according to any one of (1) to (8), wherein at least one of the first container and the second container is a flexible bag.

(10) Another tube which can be connected to another tube by a tube aseptic connection device is connected to at least one of the first container and the second container. The medical device according to any one of (9).

(11) The medical device according to any one of (1) to (10), wherein a drug is stored in at least one of the first container and the second container.

(12) The medical device according to any one of the above (1) to (11), which is for treating blood or blood components.

(13) The medical device according to (12), wherein the treatment is a virus inactivation treatment.

[0029]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a medical device of the present invention will be described in detail with reference to preferred embodiments shown in the accompanying drawings.

FIG. 1 is a plan view showing an embodiment of the medical device of the present invention. The medical device 10 shown in FIG. 1 is a triple bag used for virus inactivation processing, and has a first container 1, a second container 2, and a third container 3. First
The container 1 and the second container 2 are connected by a tube 4 so that the insides thereof communicate with each other, and the second container 2 and the third container 3 are connected so that the insides thereof communicate with each other. They are connected by a tube 5.

The first container 1 is a container for storing a virus inactivating agent (drug). This first container 1
Is formed by stacking flexible sheet materials made of a soft resin such as polyvinyl chloride, and fusing (heat fusing, high frequency fusing, etc.) or bonding at the peripheral sealing portion 1a to form a bag. (A virus inactivating agent storage bag).

In the first container 1, for example, aldehydes such as formaldehyde and glutaraldehyde, iodine and iodine compounds, vitamins and provitamins and derivatives thereof, ethyleneimine oligomers and derivatives thereof, photoreactive compounds and derivatives thereof Virus inactivating agent.

The photoreactive compound is defined as a family of compounds that undergo a chemical change in response to electromagnetic radiation. Examples thereof include coumarins, phenothiazines, fullerenes, phthalocyanines, porphyrins, and porphyrazine. , Merocyanines, hypericins, quinolines, flavins, acridines, dyes and the like.

The capacity of the first container 1 is not particularly limited, but is usually preferably about 10 to 600 ml, and more preferably about 20 to 100 ml.

The first container 1 further contains another tube 6 for introducing the blood to be processed (or blood components).
Is connected. The end of the tube 6 is sealed by fusion.

The second container 2 contains blood (or blood components)
And a virus inactivating agent. The second container 2 is formed by laminating a flexible sheet material made of a soft resin such as polyvinyl chloride, for example, and fusing (heat fusing, high frequency fusing, etc.) or It is configured by a bag (blood processing bag) that is bonded and formed into a bag shape.

Although the capacity of the second container 2 is not particularly limited, it is usually preferably about 100 to 1000 ml, more preferably about 200 to 600 ml.

The third container 3 is a container (final container) for removing the virus inactivating agent. This third container 3
For example, a flexible sheet material made of a soft resin such as polyvinyl chloride is overlapped, and is fused (heat-fused, high-frequency fused, or the like) or adhered to the peripheral seal portion 3a to form a bag-like bag. (Chemical adsorption removal bag).

The capacity of the third container 3 is not particularly limited, but is usually preferably about 100 to 1000 ml, and more preferably about 200 to 600 ml.

The third container 3 is further connected to another tube 7 for discharging the processed blood (or blood component). The end of the tube 7 is sealed by fusion.

Examples of the constituent materials of the tubes 4, 5, 6, 7 include thermoplastic elastomers such as soft polyvinyl chloride, polyethylene, polypropylene, ethylene-vinyl acetate copolymer, styrene-butadiene-styrene copolymer and the like. Or a material mainly containing them (such as a polymer blend mainly containing them). Among them, soft polyvinyl chloride or a material mainly containing soft polyvinyl chloride is preferable.

If each of the tubes 4 to 7 is made of soft polyvinyl chloride, sufficient flexibility and flexibility can be obtained, so that it is easy to handle, and it is also suitable for clogging with clamps or the like.
Furthermore, since the tube made of soft polyvinyl chloride has excellent compatibility with the sheet material of each of the containers (bags) 1 to 3 having the same main material, the joining strength when joining these by fusion or adhesion is low. It is high and excellent in airtightness, and is preferable for durability against shaking storage and centrifugation, and maintenance of sterility. In addition, the kind and content of the plasticizer used for each of the tubes 4 to 7 are not particularly limited.

In such a medical device 10, the tubes 4 and 5 (either one of the tubes 4 and 5) are connected to prevent connection (reconnection) with other tubes by a tube aseptic connection device. It has blocking means. In the present embodiment, this connection blocking means
By forming the large-diameter portion 8 in which the outer diameters of the tubes 4 and 5 are increased, it is impossible to load the tube aseptic connection device into the tube holding portion (holder). Hereinafter, the configuration of the large diameter portion 8 will be described.

As shown in FIG. 2 and FIG.
Is formed by covering the outer periphery of the tubes 4 and 5 with the covering member 81. As the covering member 81, a member formed of a tube (tube) made of the same or different material as the tubes 4 and 5 is exemplified. In this case, the constituent material of the covering member 81 is not limited to a soft resin, but may be a hard resin, a metal material, or a ceramic material.

The shape of the covering member is not limited to a tubular shape, but may be, for example, a C-shaped cross section.

The entirety of the tubes 4 and 5 is made thicker so that
It is also possible to, but in this case, each container 1 ~
In the connection part to 3, the adhesive strength is reduced,
Connection may be difficult. On the other hand, the thickness of the tubes 4 and 5 is the same as that of the conventional tube,
When the coating member 81 is separately attached to the tube to form the large-diameter portion 8, the ends of the tubes 4, 5 can be easily and reliably connected to the respective containers 1 to 3. As a result, the reliability (adhesive strength, airtightness) of the connection portion can be maintained high.

The covering member 81 is provided for the tubes 4 and 5
For example, they are preferably fixed by a method such as fusion, adhesion with an adhesive (solvent), or caulking. Further, the covering member 81 may not be fixed to the tubes 4 and 5 but may be installed rotatably or movable in the longitudinal direction with respect to the tubes 4 and 5.

Here, examples of the tube aseptic connection device include those described in JP-B-61-30582. FIG. 5 schematically shows the structure of the main part of the tube aseptic connection device.

The tube aseptic connection device 100 has a pair of holders 101a and 101b. Each holder 101
a and 101b respectively have a lid (clamp) 102
Is installed so as to be rotatable (openable and closable) by a pin 103. A buckle (not shown) that locks the lid 102 in a closed state is provided at the tip of the lid 102.

Each holder 101a, 101b is formed with two parallel grooves 104, 105 for inserting and holding tubes to be connected.
These grooves 104 and 105 have a U-shaped cross section.

The holder 101a and the holder 101b are relatively movable in the X and Y directions in FIG.

The holder 101a and the holder 101
b, between the holders 101a and 101b,
A heated cutting blade (not shown) for cutting the held tube is installed movably in the Z direction in FIG.

When the tube 4 or 5 of the medical device 10 is to be connected to another tube 106 by the tube aseptic connection device 100, the tube 106 can be loaded into the groove 104 (or 105) of both holders 101a and 101b. However, since the tube 4 or 5 has the large-diameter portion 8, the grooves 105 of the holders 101a and 101b are formed.
(Or 104) is not possible. Also, temporarily, the groove 1 of both holders 101a and 101b is used.
Even if insertion into 05 (or 104) is possible, lid 102 cannot be closed normally.

It is preferable that the tubes 4 and 5 having the large diameter portion 8 have a portion that can be sealed and cut by a tube sealer as described in, for example, JP-A-7-52924. As a result, when necessary, the first container 1 and the second container 2 and the second container 2 and the third container 3 are separated from each other, particularly while maintaining the sterility in the containers 1 to 3. can do.

Note that even after the tubes 4 and 5 are sealed and cut by the tube sealer, the tubes 4 and 5 cannot be connected to the other tubes 106 using the tube aseptic connection device 100 due to the presence of the large diameter portion 8.

The outer diameter of the large diameter portion 8 is not particularly limited as long as it cannot be loaded into the tube aseptic connection device, but is preferably about 4.6 to 5.6 mm.
More preferably, it is about 4.8 to 5.4 mm. When the outer diameter of the large diameter portion 8 is 4.6 mm or more, loading into the tube aseptic connection device 100 can be more reliably prevented. If the outer diameter of the large diameter portion 8 exceeds 5.6 mm, it may be difficult to seal the large diameter portion 8 with a generally used tube sealer.

As shown in FIG. 2, such a large diameter portion 8 is formed continuously over substantially the entire length of the tubes 4 and 5. However, as described above, the tubes 4, 5,
It is preferable that the large-diameter portion 8 is not provided at both ends, and the reliability of the connection of the tubes 4 and 5 to the containers 1 to 3 is maintained high.

The large diameter portion 8 can be formed intermittently along the longitudinal direction of the tubes 4 and 5, as shown in FIG. In this case, the length of the intermittent portion (small diameter portion) 82, that is, the gap distance L between the adjacent covering members 81 is 45
mm or less, and more preferably 40 mm or less. With such a length, loading into the tube aseptic connection device 100 can be more reliably prevented.

The gap distance L is preferably 3 mm or more, more preferably 5 mm or more.
Thereby, the tubes 4 and 5 can be easily and reliably sealed and cut at the intermittent portion 82 by the tube sealer. In this case, since it is not necessary to seal and cut the large diameter portion 8 with a tube sealer, the outer diameter of the large diameter portion 8 may exceed 5.6 mm.

The number of the intermittent portions 82 may be one or more than one for the tubes 4 and 5. In the latter case, the intermittent portions 82 are preferably formed at equal intervals along the longitudinal direction of the tubes 4 and 5, but are not limited thereto.

In the present embodiment, the large-diameter portion 8 is formed by mounting the covering member 81. However, the present invention is not limited to this. For example, the outer diameter of the tubes 4 and 5 (whole or part) can be reduced. The large diameter portion 8 may be configured to be increased.

The tubes 6 and 7 are tubes that can be connected to, for example, a blood transfusion tube (not shown) or a tube (such as the tube 106) connected to a blood transfusion bag using a tube aseptic connection device. . Therefore, as shown in FIG. 4, it has the structure which has the same outer diameter as the tubes 4 and 5 or the conventional tube.

Next, an example of a case in which a virus is inactivated on blood components using the medical device 10 will be described.

The first container 1 contains a predetermined amount of a virus inactivating agent in advance. Blood or blood components (for example, plasma, red blood cells, white blood cells, platelets, etc .; hereinafter, represented by plasma) are introduced into the first container 1.
In the method, a tube (not shown) of a plasma bag containing plasma and a tube 6 are connected by a tube aseptic connection device 100, and the first container 1 is separated from the plasma bag via these connected tubes. Transfer plasma to

The plasma introduced into the first container 1 and the virus inactivator (drug) in the first container 1 are transferred to the second container 2 via the tube 4.

[0066] The tube 4 is
(For example, in the middle of the covering member 81, at the intermittent portion 8)
2) is sealed and cut, and the unnecessary first container 1 is separated. After that, the first container 1 is discarded.

In the second container 2, plasma is mixed with a virus inactivating agent (drug) to perform a virus inactivating treatment.
When using a photoactivated virus inactivating agent, if necessary,
Irradiate light.

The plasma subjected to the virus inactivation treatment is transferred to the third container 3 via the tube 5.

[0069] The tube 5 is
(For example, in the middle of the covering member 81, at the intermittent portion 8)
2) is sealed and cut, and the unnecessary second container 2 is separated. Thereafter, the second container 2 is discarded.

In the third container 3, as necessary, as an after-treatment, excess virus inactivating agent or by-product is adsorbed and removed by an adsorbent, or neutralized or neutralized by a neutralizing agent or a decomposing agent. Decompose. Such adsorbents, neutralizers,
It is preferable that the decomposing agent is put in the second container 2 in advance.

The plasma in the third container 3 is divided into small units and formulated. The method includes a blood tube connected to a blood transfusion tube or a blood transfusion bag (not shown).
And the tube 7 are connected by the tube aseptic connection device 100, and the treated plasma in the third container 3 is transferred through the connected tubes. By performing this operation a plurality of times, the plasma in the third container 3 is subdivided into a plurality of pieces to be formulated.

When the tube 4 is mistakenly connected to the tube of the final preparation bag by the tube aseptic connection device 100 during the step, or the tube 5 is mistakenly connected by the tube aseptic connection device 100 during the step. If the product is connected to the tube of the final product bag, the product has not been subjected to virus inactivation treatment or post-treatment (treatment of virus inactivating agents or by-products). However, according to the present invention, the tubes 4 and 5 are prevented from being connected to other tubes by the tube aseptic connection device 100 by the connection prevention means as described above. Unintended operation can be prevented, and high security is ensured.

Although the medical device of the present invention has been described with reference to the illustrated embodiment, the present invention is not limited to this.

For example, in the illustrated embodiment, three containers are connected by a tube, but the number of containers may be two or four or more. The arrangement of the tubes connecting the containers is not particularly limited.

Each container (first to third containers 1 to 3)
Is not limited to a flexible (soft) bag, and the material, form, and shape of the container are not particularly limited. The container may be, for example, a plastic bottle, a bottle, a vial, a column, or a syringe.

The use of the medical device of the present invention is not limited to the above-described virus inactivation treatment. For example, leukocyte inactivation due to GVHD (graft versus host) or sepsis is caused. The present invention can be applied to various uses such as treatment of blood or blood components such as inactivation of bacteria, cell therapy including blood cell stem cell transplantation and gene therapy, and cell culture.

[0077]

Next, specific examples of the medical device of the present invention will be described.

(Example 1) A quadruple multiple bag (TERMO blood bag MAP solution, manufactured by Terumo Corporation) was prepared, and three polyvinyl chloride tubes (inner diameter: 3.0 mm, outer diameter: 3 mm) connecting each bag were connected. A jacketed tube made of polyvinyl chloride (with an inner diameter of 4.4 mm) around the entire length of the outer circumference of 4.4 mm in diameter.
0 mm, outer diameter 5.1 mm).

The tube having the coated tube is inserted into a groove (width: 4 m) of a holder of a tube aseptic connection device (Termo aseptic bonding device TSCD SC-201A) manufactured by Terumo Corporation.
m) was difficult to load. further,
The lid (clamp) of the tube aseptic connection device could not be closed normally.

Further, when an attempt was made to heat seal the mounting portion of the coated tube using a tube sealer manufactured by Terumo Corporation (Termo Tube Sealer AC-157), aseptic sealing and cutting of the tube was possible. there were.

(Example 2) A quadruple multiple bag (TERMO blood bag MAP solution, manufactured by Terumo Corporation) was prepared, and three polyvinyl chloride tubes (3.0 mm inner diameter, outer On the outer circumference of 4.4 mm in diameter, a polyvinyl chloride coated tube (inner diameter 4.0 mm, outer diameter 5.4)
mm, length 70 mm).

The coating tube was intermittently arranged in the longitudinal direction so that an intermittent portion having a length L of 5 mm was formed.

The tube having the coated tube is inserted into a groove (width: 4 m) of a holder of a tube aseptic connection device (Termo aseptic joining device TSCD SC-201A) manufactured by Terumo Corporation.
m), but it was impossible.

Further, when the mounting portion and the intermittent portion of the coated tube were heat-sealed using a tube sealer (TERMO Tube Sealer AC-157) manufactured by Terumo Co., Ltd., both were sterilized. Sealing and cutting were possible.

(Example 3) A quadruple multiple bag (TERMO blood bag MAP solution manufactured by Terumo Corporation) was prepared, and three polyvinyl chloride tubes (3.0 mm inner diameter, outer On the outer circumference of 4.4 mm in diameter, a polyvinyl chloride coated tube (inner diameter 4.0 mm, outer diameter 6.0)
mm, length 70 mm).

The coating tube was intermittently arranged in the longitudinal direction so that an intermittent portion having a length L of 8 mm was formed.

The tube having the coated tube is inserted into a groove (width: 4 m) of a holder of a tube aseptic connection device (Termo aseptic joining device TSCD SC-201A) manufactured by Terumo Corporation.
m), but it was impossible.

Further, the intermittent part was replaced with a tube sealer manufactured by Terumo Corporation (Termo Tube Sealer AC-157).
When heat fusion was attempted using, aseptic sealing and cutting of the tube was possible.

[0089]

As described above, according to the medical device of the present invention, even if a tube is erroneously connected to another tube with a tube aseptic connection device, the connection is impossible or difficult. Incorrect connection is prevented.

Therefore, blood or blood components in the middle of the treatment process are prevented from being used clinically due to, for example, an error, thereby contributing to an improvement in the safety of blood products.

Further, even if connection with a tube aseptic connection device is not possible, the container can be sealed and cut by a tube sealer, so that the container can be cut and separated aseptically. The efficiency of the manufacturing process can be improved.

[Brief description of the drawings]

FIG. 1 is a plan view showing an embodiment of the medical device of the present invention.

FIG. 2 is a perspective view showing a configuration example of a connection preventing means (large-diameter portion) in the medical device of the present invention.

FIG. 3 is a perspective view showing a configuration example of a connection preventing means (large-diameter portion) in the medical device of the present invention.

FIG. 4 is a perspective view showing a configuration of a tube that can be connected using a tube aseptic connection device.

FIG. 5 is a perspective view schematically showing a structure of a main part of the tube aseptic connection device.

[Explanation of symbols]

Reference Signs List 10 medical device 1 first container (bag for storing virus inactivating agent) 2 second container (bag for treating blood) 3 third container (bag for treating drug adsorption and removal) 4 tube 5 tube 6 tube (tube for blood introduction) 7 Tube (blood discharge tube) 8 Large diameter portion 81 Coating member 82 Intermittent portion 100 Tube aseptic connection device 101a Holder 101b Holder 102 Lid 103 Pin 104 Groove 105 Groove 106 Tube

Claims (8)

[Claims] A first container, a second container, and the first container;
A medical device having a container for connecting the container and the second container, wherein the tube includes connection prevention means for preventing connection with another tube by a tube aseptic connection device. Features medical equipment. 2. The connection preventing device according to claim 1, wherein a large-diameter portion having an increased outer diameter of the tube is formed so that the tube aseptic connection device cannot be loaded into the tube holding portion. A medical device according to claim 1. 3. The medical device according to claim 2, wherein the large-diameter portion is formed by attaching a covering member. 4. The medical device according to claim 1, wherein the tube has a portion that can be sealed and cut by a tube sealer. 5. A tube according to claim 1, wherein at least one of said first container and said second container is connected to another tube which can be connected to another tube by a tube aseptic connection device. The medical device according to any one of the above. 6. The medicine container according to claim 1, wherein at least one of said first container and said second container contains a medicine.
The medical device according to any one of the above. 7. The medical device according to claim 1, which is for treating blood or blood components. 8. The medical device according to claim 7, wherein the treatment is a virus inactivation treatment.