JPH11178918A - Medical heat exchanger bag - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical heat exchanger bag which securely prevents breakage due to decreased pressure or heating during disinfection. SOLUTION: In a medical heat exchanger bag in which multiple sheets 3 facing each other are heat-welded, and liquid paths communicating with the inlet and outlet for connection and a non-heat-welded part 8 in approximately sealed condition which is formed outside the liquid paths resulting from heat- welding the peripheral edge of the sheet 3 are provided, for example, a communication part communicating with the inside and outside areas during disinfection is provided at the non-heat-welded part 8. The communication part is provided at either side of the sheets 3 forming the non-heat-welded part 3, or at welded parts 4, 5, 6 of the circumference of the sheet 3 forming the non-heat-welded part 8.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical heat exchange bag used for heating a replacement fluid for supplementing water removed from blood in hemodiafiltration or the like.

[0002]

2. Description of the Related Art Conventionally, a general medical heat exchange bag is:
A bag-like liquid flow path is formed by stacking and partially heat-welding two PVC sheets, and the outer peripheral edge of the PVC sheet is heat-welded. The reason why the outer peripheral end portion of the PVC sheet is thermally welded is that a predetermined stiffness is obtained in the entire heat exchange bag, that the unwelded end surface portion of the PVC sheet is prevented from being bent, and that the assembling work and the packing work are performed. This is due to the fact that it is easy to handle and the desorption property to the heat exchange device becomes good.

[0003] Then, the medical heat exchange bag thus formed is placed in a sterile bag and EOG (eth
Medical sterilization bags are manufactured by sterilizing (yelene oxide Gas). The medical heat exchange bag is mounted on a heat exchange device having an external heat source such as a heater, so that heat exchange of the replacement fluid (replenisher) in the liquid flow path is performed via the PVC sheet.

[0004]

However, in such a medical heat exchange bag, since the residual sterilant during EOG sterilization adversely affects the living body, a sufficient amount of physiological saline or the like is used before use. There is a problem that cleaning is required. In order to eliminate this defect, for example, it is conceivable to apply steam sterilization, which is mainly used for medical heat exchange bags other than medical heat exchange bags, to this medical heat exchange bag. When applied to an exchange bag, there are the following problems due to its structure.

That is, in the medical heat exchange bag manufactured as described above, the heat-welded portions are on both sides of the liquid flow path and the outer peripheral end of the PVC sheet, and are not heat-welded outside the liquid flow path. Thus, a sealed space is formed between the heat-welded portion forming the fluid flow path and the outer peripheral welded portion. When the medical heat exchange bag is steam-sterilized, the outside of the heat exchange bag is decompressed more than the decompression performed in the sterilization process, so that the air in the closed space expands and the heat exchange bag is damaged. In particular, if there is a heat treatment in the sterilization process, not only the expansion rate becomes larger, but also the PV
Since the strength of the C sheet also decreases, the tendency of breakage increases.

Therefore, a method of eliminating the non-heat-welded portion by heat-welding all the portions other than the liquid flow path can be considered. However, if the width of the heat-welded portion is increased in this way, the heat-welding strength is partially reduced. In this case, the heat-welded portion is easily broken, and is not actually used. That is, in the case of heat welding, if the width of the heat-welded portion is not constant (a part is wide and a part is narrow), it is necessary to set a high heat-welding condition in order to obtain the welding strength of the wide part. Due to these heat welding conditions, the narrow part becomes excessive heat weld, and P
This is because the thickness of the VC sheet is partially reduced, which causes breakage.

The present invention has been made in view of such circumstances, and an object of the present invention is to provide a medical heat exchange bag capable of reliably preventing damage due to decompression or heating during sterilization. To provide.

[0008]

In order to achieve the above object, the invention according to claim 1 of the present invention is formed by heat-welding a plurality of sheets facing each other, and communicates with a connection port. In a medical heat exchange bag having a liquid flow path and a substantially closed non-heat-welded part formed outside the liquid flow path by heat-welding the outer peripheral end of the sheet, the non-heat-welded part is sterilized. It is characterized in that a communication portion that can sometimes communicate inside and outside is provided.

[0009] With this configuration, the liquid passage and the substantially non-heat-welded portion in a substantially closed state are formed in the medical heat exchange bag by heat-sealing the opposing sheets. For example, when steam is sterilized, air trapped inside the non-heat-welded portion is discharged to the outside from the communication portion provided in the non-heat-welded portion, and expansion in the non-heat-welded portion is prevented. This eliminates breakage of the sheet forming the non-heat-welded portion and enables steam sterilization, which has been conventionally difficult with high heating conditions during sterilization, and reliably prevents, for example, adverse effects on the living body due to residual sterilant. Is done.

The communicating portion provided in the non-heat-welded portion is formed by a slit or a hole provided in at least one of the sheets forming the non-heat-welded portion, as in the second aspect of the present invention. As in the third aspect of the present invention, it is formed by not welding a part of the heat-welded portion at the outer peripheral end of the sheet forming the non-heat-welded portion. By this communication portion, the expanded air in the non-heat-welded portion at the time of sterilization is discharged to the outside to prevent the sheet from being damaged.

[0011]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the present invention will be described below in detail with reference to the drawings. 1 to 4 show an embodiment of the medical heat exchange bag according to the present invention, and FIG.
3 is a cross-sectional view thereof, FIG. 2 is a cross-sectional view taken along line AA of FIG. 1, and FIG.
3 is an enlarged view of a portion B in FIG. 1, and FIG. 4 is a sectional view taken along line CC of FIG.

In FIG. 1 and FIG. 2, a medical heat exchange bag 1 (hereinafter, referred to as a heat exchange bag 1) has a substantially rectangular outer shape in plan view due to heat welding of two opposing PVC sheets 2, 3. It is formed in a shape. In the PVC sheets 2 and 3, one meandering liquid flow path 7 and many non-thermally welded parts 8 are formed by a pair of meandering welds 4 and 5 and a weld 6 at the outer peripheral end. ing.

The liquid flow path 7 includes liquid flow path portions 2a, 3a of two PVC sheets 2, 3 located inside the welded portions 4, 5.
a both ends 7a, 7a of the liquid flow path 7
b has an inlet 9 and an outlet 10 for connection.
For example, a tube (not shown) is connected to the inlet 9 and the outlet 10 during hemofiltration and dialysis.

The non-heat-welded portion 8 is located outside the liquid flow path 7,
That is, the non-welded portions 2b and 3b of the two PVC sheets 2 and 3 located between the welded portions 4 and 5 and the welded portion 6 are formed.
A slit 11 is formed in each of 3b. As shown in FIGS. 3 and 4, the slit 11 has a predetermined length and width, and the non-welded portion 2 of the PVC sheets 2 and 3.
b, 3b are formed in a state where they communicate with each other.

According to the heat exchange bag 1, when the pressure is reduced and heated during the steam sterilization, the internal space 8 of the non-heat-welded portion 8 is heated.
a (see FIGS. 3 and 4) expands, and the expanded air is caused by the non-welded portions 2b and 3b of the PVC sheets 2 and 3.
Is discharged to the outside of the non-heat-welded portion 8 (outside of the heat exchange bag 1) from the slit 11 formed at the bottom, preventing tearing of the PVC sheets 2 and 3 and sealing failure due to the tongue and tear of the welded portions 4 to 6. You.

The slits 11 formed in the non-heat-welded portions 8 are not limited to those that communicate in advance with the inside and outside of the non-welded portions 2b, 3b of the PVC sheets 2, 3, but in a normal state,
When the internal space 8a of the non-heat-welded portion 8 is sealed, and a pressure is applied during steam sterilization, the internal space 8a may be formed by a cut-shaped slit communicating inside and outside, or for example, the slit 11 may be formed in a cross shape. Can also.

As described above, the heat exchange bag 1 of the above embodiment
In the above, the PVC sheet 2 forming the non-heat-welded portion 8,
3, the slits 11 are formed in the non-welded portions 2b and 3b, so that when the heat exchange bag 1 is steam-sterilized, the expanded air in the internal space 8a of the non-heat-welded portion 8 can be easily discharged to the outside through the slits 11. PVC sheet 2,
3 is reliably prevented. As a result, the heat exchange bag 1 can be sterilized by steam sterilization, which was conventionally impossible because the heating condition is higher than that of EOG sterilization. It is possible to prevent adverse effects on the external circulation circuit with physiological saline, for example, and to simplify the operation.

Further, since the pressure due to the expanded air does not act on the internal space 8a of the non-thermally welded portion 8, the welding portions 4, 5 forming the liquid flow path 7 can be reliably prevented from cracking. Especially,
Liquid leakage (leakage of the liquid to the outside of the heat exchange bag 1) due to poor sealing of the welded portion 6 at the outer peripheral end can be easily found by a pressure test. The liquid leak due to the failure is difficult to detect even by a pressure test because the liquid leak is stopped by the welded portion 6.

However, in the above-described heat exchange bag 1, when a liquid leaks at the welding portions 4 and 5, this liquid flows through the internal space 8 a of the non-heat welding portion 8 and the slit 11 to cause the heat exchange bag 1 to leak. Since the liquid leaks to the outside, it is possible to easily detect a defective seal due to the liquid leakage, and the accuracy of detecting the defective heat exchange bag 1 can be improved.

The heat exchange bag 1 having the slits 11 having the shapes shown in FIGS. 3 and 4 and the heat exchange bag having no slits 11 were respectively manufactured in sets of 10 and steam sterilized. In the heat exchange bag 1 having no abnormalities such as rupture of the PVC sheets 2 and 3 were observed at all. On the other hand, in the case of the heat exchange bag having no slit 11, all 10 sets burst at at least one portion of the non-heat-welded portion 8, and the above effect has been experimentally confirmed.

5 and 6 show another embodiment of the heat exchange bag according to the present invention. FIG. 5 is an enlarged view similar to FIG.
FIG. 6 is a sectional view taken along line D-D in FIG. The feature of the heat exchange bag 1 of this embodiment is that the slit 1 serves as a communicating portion.
1 in that a hole 12 is provided instead of 1. That is, the PVC sheets 2 and 3 forming the non-heat-welded portion 8 of the heat exchange bag 1
In the non-welded portions 2b, 3b, holes 12 having a predetermined inner diameter communicating with the inside and outside are formed, respectively. The other configuration is the same as that of the above-described embodiment, and therefore, the same reference numerals are given and the detailed description is omitted. The same applies to the following embodiments.

In the heat exchange bag 1 of this embodiment,
Since the expanded air in the internal space 8a of the non-heat-welded portion 8 at the time of steam sterilization is discharged to the outside through the holes 12, the PVC sheets 2 and 3 are prevented from being broken. The same operation and effect can be obtained.

In each of the above-described embodiments, the slit 11 or the hole 12 as the communicating portion is provided in the non-heat-welded portion 8.
Are formed on both the non-welded portions 2b and 3b of the PVC sheets 2 and 3, respectively. However, the present invention is not limited to this. For example, only the non-welded portions 2b and 3b of one of the PVC sheets 2 and 3 are formed. Forming slits 11 and holes 12,
For example, the slit 11 and the hole 12 can be used together.

Further, the slit 11 in each of the above embodiments is used.
The shape such as the length and width of the hole 12 and the inner diameter of the hole 12 is
Can be appropriately set in accordance with the size of the liquid flow path 7, the shape of the liquid flow path 7, and the like.
The PVC sheets 2 and 3 may be heat-welded, or a communication portion such as the slit 11 may be formed in the PVC sheets 2 and 3 after the heat-sealing.

7 and 8 show still another embodiment of the heat exchange bag according to the present invention. FIG. 7 is a sectional view similar to FIG. 1, and FIG. 8 shows an example of a method of forming a communicating portion. It is a fragmentary sectional view. The feature of the heat exchange bag 21 of this embodiment is that the communicating portion provided in the non-heat-welded portion 8
It is in the point provided in. That is, the welding portion 6 on the outer peripheral end of the sheets 2 and 3 forming the non-heat welding portion 8 of the heat exchange bag 21
The opening 22 is provided in a part of the.

The opening 22 is formed by not welding the opening 22 at the time of thermal welding of the welded portions 6 of the sheets 2 and 3. For example, as shown in FIG.
An opening 22 is formed as shown in FIG. 8 (b) by heat-welding the welded portion 6 at the outer peripheral end of the sheets 2, 3, and then cutting and cutting the position indicated by the two-dot chain line a. You can also.

Further, at least one opening 22 is provided in the welded portion 6 forming each non-heat-welded portion 8, and the size thereof is, for example, as shown in FIG. (Internal volume) may be set to different sizes, or may be set to the same size. Also in the heat exchange bag 21 of this embodiment, the expanded air in the non-heat-welded portion 8 at the time of steam sterilization is discharged to the outside through the opening 22, and the operation and effect are exactly the same as those of the heat exchange bag 1 of the above embodiment. Is obtained.

The present invention is not limited to each of the above-described embodiments.
The opening 22 of the heat exchange bag 1 is formed so as to open at a predetermined pressure in the same manner as the slit 11 of the heat exchange bag 1, or the slit 11 is provided in the welded portion 6 forming the non-heat-welded portion 8 of the heat exchange bag 21. The respective embodiments can also be appropriately combined, for example, the opening 22 is formed.

Further, in the above-described embodiment, the case where the method of sterilizing the heat exchange bag 1 is steam sterilization has been described. Although more effective when applied, it is not limited to this steam sterilization, and can be applied to various sterilization methods having a decompression step or a heating step such as EOG sterilization. Further, the overall shape of the heat exchange bags 1 and 21, the shape of the liquid flow path 7, the positions of the entrances and exits 9 and 10 in the above embodiments are merely examples, and can be variously changed without departing from the gist of the present invention. Needless to say.

[0030]

As described in detail above, claims 1 to 3
According to the described invention, since a communicating portion including a slit, a hole, an opening, and the like that can communicate with the inside and outside of the non-heat-welded portion is provided, the expanded air in the non-heat-welded portion due to decompression and heating during sterilization is provided. The heat exchange bag can be discharged to the outside through the communication portion, and the heat exchange bag can be reliably prevented from being damaged during sterilization.

In addition, it is possible to detect a poor sealing of the heat-welded portion forming the liquid flow path by leaking the liquid to the outside of the heat exchange bag through the communicating portion, thereby making it easy to detect the defect of the heat exchange bag. Effects can also be obtained.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view showing one embodiment of a medical heat exchange bag according to the present invention.

FIG. 2 is a sectional view taken along the line AA of FIG. 1;

FIG. 3 is an enlarged view of a portion B in FIG. 1;

FIG. 4 is a sectional view taken along line CC of FIG. 3;

FIG. 5 is an enlarged view similar to FIG. 3, showing another embodiment of the medical heat exchange bag according to the present invention.

FIG. 6 is a sectional view taken along line DD of FIG. 5;

FIG. 7 is a sectional view similar to FIG. 1, showing still another embodiment of the medical heat exchange bag according to the present invention.

FIG. 8 is an essential part cross-sectional view showing one example of a method of forming the communication part;

[Explanation of symbols]

 1, 21 Medical heat exchange bag 2, 3 PVC sheet 2a, 3a Liquid flow path part 2b, 3b Non-welded part 4, 5, 6 Welded part 7 Liquid flow path 8 Non-heat welded part 8a Internal space 9 Inlet 10 Outlet 11 Slit 12 hole 22 opening

Claims (3)

[Claims] 1. A liquid flow path formed by heat-welding a plurality of sheets facing each other and communicating with an inlet / outlet for connection, and an outer peripheral end of the sheet being heat-welded to the outside of the liquid flow path. In a medical heat exchange bag having a substantially heat-sealed non-heat-welded portion formed therein, the non-heat-welded portion is provided with a communication portion capable of communicating inside and outside during sterilization. Exchange bag. 2. The medical heat exchange bag according to claim 1, wherein the communication portion is provided on at least one of the sheets forming the non-heat-welded portion. 3. The medical heat exchange bag according to claim 1, wherein the communication portion is provided at a welded portion at an outer peripheral end of a sheet forming a non-heat-welded portion.