JP7478422B2 - Internal insertion tube set - Google Patents

Description

The present invention relates to an intracorporeal insertion tube set.

Conventionally, there has been known a tracheal tube assembly including a tracheal tube with an inflatable cuff and a flexible expansion wire for inflating the cuff (see, for example, Patent Document 1). In the technology described in Patent Document 1, the tracheal tube assembly before use is contained in a package (packaging bag) made of a sheet of gas-permeable paper and a sheet of flexible plastic.
In addition, in the technology described in Patent Document 1, in order to prevent part of the flexible expansion wire from being positioned at the edge (heat-sealed portion) of the package (packaging bag) during the heat-sealing process of the package (packaging bag), the device side end of the flexible expansion wire is held together with the tracheal tube.
However, in the technology described in Patent Document 1, an adapter for holding the device end of the flexible expansion wire together with the tracheal tube is included in the tracheal tube assembly, which increases the cost of the entire tracheal tube assembly.

Also, a tracheal intubation set including an endotracheal tube to be inserted into the trachea and a packaging bag for housing the endotracheal tube has been known (see, for example, Patent Document 2). In the technology described in Patent Document 2, the endotracheal tube before use is housed in the packaging bag.
However, in the technique described in Patent Document 2, a cuff is not provided on the endotracheal tube.
Therefore, Patent Document 2 does not describe a method for checking for the presence or absence of an abnormality in the cuff inflation system without the need to remove the entire endotracheal tube from the packaging bag.

After removing the entire tracheal tube assembly from the package or the entire endotracheal tube from the packaging bag, the task of checking for any abnormalities in the cuff inflation system is very tedious for emergency medical technicians who are required to perform tracheal intubation quickly in a small space, for example. Therefore, there is a need for improvements in the packaging of tracheal tube assemblies or packaging bags for endotracheal tubes.

Japanese Patent Application Laid-Open No. 61-79468 JP 2008-206568 A

In view of the above problems, the present invention aims to provide an internal insertion tube set that can check for abnormalities in the inflation system without having to remove the entire internal insertion tube from the packaging bag while suppressing overall costs.

One aspect of the present invention is an internal insertion tube set including an internal insertion tube having a tube body and an inflation system, and a packaging bag that contains the internal insertion tube, the tube body including a tip end and a base end located on the opposite side of the tip end, the inflation system including a cuff, an inflation line extending from the cuff, and a pilot balloon located on the opposite side of the cuff across the inflation line, and the packaging bag including a positioning part that brings the base end and the pilot balloon adjacent to each other when the internal insertion tube is contained in the packaging bag.

In one aspect of the present invention, the internal insertion tube set may be configured such that the packaging bag is formed by joining a first outer periphery that is the outer periphery of a first sheet and a second outer periphery that is the outer periphery of a second sheet, and the positioning portion is formed by joining a first joint that is a part of the non-outer periphery of the first sheet and a second joint that is a part of the non-outer periphery of the second sheet.

In one aspect of the present invention, the positioning part may be located between the tube body and the pilot balloon when the internal insertion tube is housed in the packaging bag.

In one aspect of the present invention, the packaging bag has a valve portion disposed adjacent to the pilot balloon, and the valve portion may have a through hole configured to allow the tip of a syringe that supplies air to the pilot balloon to be inserted and removed.

In one embodiment of the present invention, the depth dimension of the through hole may be smaller than the length dimension of the tip portion.

The internal insertion tube set of one aspect of the present invention further includes a lubricant containing bag that contains a lubricant to be supplied to the cuff, and the lubricant containing bag is fixed to the packaging bag, and the lubricant may be supplied to the cuff while the internal insertion tube is contained in the packaging bag.

In one aspect of the present invention, the strength of the lubricant-containing bag may be lower than the strength of the packaging bag.

The intracorporeal insertion tube set of one aspect of the present invention further includes a stylet that is contained in the packaging bag while not being inserted into the intracorporeal insertion tube, and the lubricant may be supplied to the cuff and the stylet while the intracorporeal insertion tube and the stylet are contained in the packaging bag.

In one aspect of the present invention, the internal insertion tube set may be removed from one end of the packaging bag, and the stylet may be removed from the other end of the packaging bag.

This invention provides an internal insertion tube set that can check for abnormalities in the inflation system without having to remove the entire internal insertion tube from the packaging bag while keeping overall costs down.

FIG. 2 is a diagram showing an example of a configuration of an intracorporeal insertion tube set according to the first embodiment. 1A to 1C are diagrams showing an example of an internal insertion tube before being housed in a packaging bag. 3 is an exploded perspective view of a packaging bag for explaining an example of a method of housing the internal insertion tube shown in FIGS. 1 and 2(A) in the packaging bag. FIG. FIG. 13 is a diagram showing an example of a configuration of an intracorporeal insertion tube set according to a second embodiment. 5 is an exploded perspective view of a packaging bag for explaining an example of a method of housing the internal insertion tube shown in FIG. 4 in the packaging bag. FIG. 13 is a diagram for explaining an example of a method for checking the presence or absence of an abnormality in the inflation system of the intracorporeal insertion tube set according to the second embodiment. FIG. FIG. 13 is a diagram showing an example of a configuration of an intracorporeal insertion tube set according to a third embodiment. 8 is an exploded perspective view of a packaging bag for explaining an example of a method for housing the internal insertion tube and the lubricant containing bag shown in FIG. 7 in the packaging bag. FIG.

The following describes an embodiment of the intracorporeal insertion tube set of the present invention with reference to the drawings.

[First embodiment]
Fig. 1 is a diagram showing an example of the configuration of the intracorporeal insertion tube set 1 of the first embodiment. In detail, Fig. 1 is a diagram showing the intracorporeal insertion tube set 1 in a state in which the intracorporeal insertion tube 11 is housed in a packaging bag 14. Fig. 2 is a diagram showing an example of the intracorporeal insertion tube 11 before being housed in the packaging bag 14. In detail, Fig. 2(A) shows an example of the intracorporeal insertion tube 11 before being housed in the packaging bag 14, and Fig. 2(B) shows an example of a syringe SY applied to the intracorporeal insertion tube 11 shown in Fig. 2(A).
In the example shown in Figs. 1 and 2, the intracorporeal insertion tube set 1 includes an intracorporeal insertion tube 11 and a packaging bag 14 that houses the intracorporeal insertion tube 11 in a sterilized state, for example.
The internal insertion tube 11 is a tube that is inserted into an organ such as the trachea, esophagus, or large intestine of a human or animal. The internal insertion tube 11 includes a tube main body 11A and an inflation system 11B. The tube main body 11A is a tubular part, and is a part that ventilates the trachea when the internal insertion tube 11 is used for tracheal intubation, for example.
The tube main body 11A has a tip end 11A1 and a base end 11A2 disposed on the opposite side of the tip end 11A1. The tip end 11A1 is a portion that is inserted into an organ such as the trachea, esophagus, or large intestine of a human or animal when the internal insertion tube 11 is in use. The base end 11A2 is a portion that is disposed (left) outside the human or animal body without being inserted into an organ such as the trachea, esophagus, or large intestine when the internal insertion tube 11 is in use.

The inflation system 11B includes a cuff 11B1, an inflation line 11B2, and a pilot balloon 11B3.
The cuff 11B1 is a part that performs sealing between the outer peripheral surface of the tube main body 11A and the inner wall surface of an organ. The cuff 11B1 is configured to be inflatable. To facilitate understanding of the cuff 11B1, Fig. 2(A) shows the cuff 11B1 in an inflated state. In reality, the internal body insertion tube 11 is housed in the packaging bag 14 with the cuff 11B1 not inflated as shown in Fig. 1.
The inflation line 11B2 extends from the cuff 11B1. The pilot balloon 11B3 is disposed on the opposite side of the cuff 11B1 (the right side in Figs. 1 and 2A) across the inflation line 11B2. The pilot balloon 11B3 is used to inject air into the cuff 11B1 to inflate the cuff 11B1. The pilot balloon 11B3 is also used to deflate the cuff 11B1.
In other words, the inflation system 11B is a system involved in maintaining the internal pressure of the cuff 11B1. The pilot balloon 11B3 of the inflation system 11B is configured to be connectable to a syringe SY (see FIG. 2B). In detail, the pilot balloon 11B3 and the syringe SY are connected by inserting the tip SY1 (see FIG. 2B) of the syringe SY into the pilot balloon 11B3.

FIG. 3 is an exploded perspective view of the packaging bag 14 for explaining an example of a method for housing the internal insertion tube 11 shown in FIGS.
In the example shown in FIG. 3, the packaging bag 14 includes a first sheet 14-1 and a second sheet 14-2.
The first sheet 14-1 has an outer peripheral portion 14-1A and a non-outer peripheral portion which is the portion other than the outer peripheral portion 14-1A. The non-outer peripheral portion of the first sheet 14-1 includes a joining portion 14-1B which is the portion joined to the second sheet 14-2.
The second sheet 14-2 has an outer peripheral portion 14-2A and a non-outer peripheral portion which is the portion other than the outer peripheral portion 14-2A. The non-outer peripheral portion of the second sheet 14-2 includes a joining portion 14-2B which is the portion joined to the first sheet 14-1.

1 to 3, when the internal insertion tube 11 is housed in the packaging bag 14, the internal insertion tube 11 is disposed between the first sheet 14-1 and the second sheet 14-2. That is, the internal insertion tube 11 is disposed below the first sheet 14-1 in Fig. 3 and above the second sheet 14-2 in Fig. 3.
Next, the outer peripheral portion 14-1A of the first sheet 14-1 and the outer peripheral portion 14-2A of the second sheet 14-2 are joined by any known method such as welding, and the joining portion 14-1B of the first sheet 14-1 and the joining portion 14-2B of the second sheet 14-2 are joined by a similar method. As a result, the internal body insertion tube 11 is housed in the packaging bag 14 (as shown in FIG. 1).
In detail, the positioning portion 14A (see FIG. 1) is formed by joining the joint portion 14-1B of the first sheet 14-1 and the joint portion 14-2B of the second sheet 14-2 to each other. That is, the packaging bag 14 formed by joining the outer periphery 14-1A of the first sheet 14-1 and the outer periphery 14-2A of the second sheet 14-2 is provided with the positioning portion 14A.

In the example shown in FIGS. 1 to 3, when the internal insertion tube 11 is contained in the packaging bag 14 as shown in FIG. 1, the positioning portion 14A is located between the tube main body 11A and the pilot balloon 11B3 of the inflation system 11B.
In other words, the positioning portion 14A has a function of aligning the base end portion 11A2 of the tube main body 11A and the pilot balloon 11B3 in a state in which the internal insertion tube 11 is contained in the packaging bag 14.
Therefore, in the example shown in FIGS. 1 to 3, when a user of the internal insertion tube set 1 takes out the internal insertion tube 11 from the packaging bag 14, it is possible to prevent the pilot balloon 11B3 from moving to the side of the tip portion 11A1 of the internal insertion tube 11 (the left side in FIG. 1).

Before inserting the internal insertion tube set 1 into an organ of a human or animal, a user of the internal insertion tube set 1, such as a paramedic, needs to confirm that there is no abnormality in the inflation system 11B related to maintaining the internal pressure of the cuff 11B1 by actually inflating the cuff 11B1.
1 to 3, in order for a user of the intracorporeal insertion tube set 1 to check for the presence or absence of an abnormality in the inflation system 11B, it is not necessary for the user to remove the entire intracorporeal insertion tube 11 from the packaging bag 14. The user of the intracorporeal insertion tube set 1 need only open, for example, only a portion of the packaging bag 14 (a portion on the upper right side in FIG. 1) to expose only a portion of the pilot balloon 11B3 to the outside of the packaging bag 14.
In detail, the user of the intracorporeal insertion tube set 1 can inflate the cuff 11B1 by connecting the pilot balloon 11B3 and the syringe SY through the opened portion of the packaging bag 14.

That is, in the example shown in FIGS. 1 to 3, the user of the intracorporeal insertion tube set 1 can check for the presence or absence of an abnormality in the inflation system 11B without having to remove the entire intracorporeal insertion tube 11 from the packaging bag 14.
1 to 3, in a state in which the internal insertion tube 11 is contained in a packaging bag 14 as shown in Fig. 1, there is no need to provide the internal insertion tube 11 with an adapter as described in Patent Document 1 in order to adjacently position the base end portion 11A2 of the tube main body 11A and the pilot balloon 11B3. Therefore, in the example shown in Figs. 1 to 3, the overall cost of the internal insertion tube set 1 can be reduced more than with the technique described in Patent Document 1.

[Second embodiment]
A second embodiment of the intracorporeal insertion tube set of the present invention will now be described.
Except for the points described below, the intracorporeal insertion tube set 1 of the second embodiment is configured similarly to the intracorporeal insertion tube set 1 of the above-mentioned first embodiment. Therefore, the intracorporeal insertion tube set 1 of the second embodiment can achieve the same effects as the intracorporeal insertion tube set 1 of the above-mentioned first embodiment, except for the points described below.

FIG. 4 is a diagram showing an example of the configuration of the intracorporeal insertion tube set 1 according to the second embodiment.
In the example shown in FIG. 4, the intracorporeal insertion tube set 1 includes an intracorporeal insertion tube 11 configured similarly to the examples shown in FIG. 1 and FIG. 2(A), and a packaging bag 14 that contains the intracorporeal insertion tube 11 in, for example, a sterilized state.

FIG. 5 is an exploded perspective view of the packaging bag 14 for explaining an example of a method for housing the internal insertion tube 11 shown in FIG.
In the example shown in FIG. 5, the packaging bag 14 includes a first sheet 14-1, a second sheet 14-2, and a valve portion 14B.
The first sheet 14-1 has an outer peripheral portion 14-1A and a non-outer peripheral portion. The non-outer peripheral portion of the first sheet 14-1 includes a bonding portion 14-1B.
The second sheet 14-2 has an outer peripheral portion 14-2A and a non-outer peripheral portion. The non-outer peripheral portion of the second sheet 14-2 includes a bonding portion 14-2B.
The valve portion 14B has a through hole 14B1. The through hole 14B1 of the valve portion 14B is configured to allow the insertion and removal of a tip portion SY1 (see FIG. 2B) of a syringe SY (see FIG. 2B) that supplies air to the pilot balloon 11B3 (see FIG. 4).

4 and 5, when the internal body insertion tube 11 is contained in the packaging bag 14, the internal body insertion tube 11 and the valve section 14B are disposed between the first sheet 14-1 and the second sheet 14-2. That is, the internal body insertion tube 11 and the valve section 14B are disposed below the first sheet 14-1 in Fig. 5 and above the second sheet 14-2 in Fig. 5.
Next, the outer periphery 14-1A of the first sheet 14-1 and the outer periphery 14-2A of the second sheet 14-2 are joined by any known method such as welding, and the joining portion 14-1B of the first sheet 14-1 and the joining portion 14-2B of the second sheet 14-2 are joined by a similar method. The valve portion 14B is joined by a part of the outer periphery 14-1A of the first sheet 14-1 and a part of the outer periphery 14-2A of the second sheet 14-2 by a similar method. As a result, the internal body insertion tube 11 is housed in the packaging bag 14 (the state shown in FIG. 4), and the valve portion 14B is sandwiched between the outer periphery 14-1A of the first sheet 14-1 and the outer periphery 14-2A of the second sheet 14-2.

In the example shown in FIGS. 4 and 5, when the internal insertion tube 11 is housed in the packaging bag 14 as shown in FIG. 4, the positioning portion 14A is located between the tube main body 11A and the pilot balloon 11B3 of the inflation system 11B.
Therefore, in the example shown in FIGS. 4 and 5, similarly to the example shown in FIGS. 1 to 3, when a user of the intracorporeal insertion tube set 1 removes the intracorporeal insertion tube 11 from the packaging bag 14, it is possible to prevent the pilot balloon 11B3 from moving to the side of the tip portion 11A1 of the intracorporeal insertion tube 11 (the left side in FIG. 4).
In the example shown in FIGS. 4 and 5, in a state in which the internal insertion tube 11 is contained in the packaging bag 14 as shown in FIG. 4, the valve portion 14B is disposed adjacent to the pilot balloon 11B3.

4 and 5, the user of the intracorporeal insertion tube set 1 does not need to remove the entire intracorporeal insertion tube 11 from the packaging bag 14 in order to check for the presence or absence of an abnormality in the inflation system 11B.
Specifically, in the example shown in Figs. 4 and 5, the user of the intracorporeal insertion tube set 1 does not need to open the packaging bag 14 in order to check for the presence or absence of an abnormality in the inflation system 11B.

Fig. 6 is a diagram for explaining an example of a method for checking the presence or absence of an abnormality in the inflation system 11B of the intracorporeal insertion tube set 1 according to the second embodiment. In detail, Fig. 6 is a diagram showing an enlarged cross section of the valve portion 14B and the like.
6, in the intracorporeal insertion tube set 1 of the second embodiment, when checking for the presence or absence of an abnormality in the inflation system 11B, the tip portion SY1 of the syringe SY is inserted into the through hole 14B1 of the valve portion 14B. The depth dimension DB of the through hole 14B1 is set to a value smaller than the length dimension LS of the tip portion SY1 of the syringe SY.
Therefore, when the tip SY1 of the syringe SY is inserted into the through hole 14B1 of the valve portion 14B, a part of the tip SY1 of the syringe SY protrudes to the inside of the packaging bag 14 (the left side in FIG. 6).
Therefore, a user of the intracorporeal insertion tube set 1 can inflate the cuff 11B1 by connecting a part of the tip portion SY1 of the syringe SY (the part protruding inside the packaging bag 14) to the pilot balloon 11B3.
That is, in the examples shown in FIGS. 4 to 6, the user of the intracorporeal insertion tube set 1 can check for the presence or absence of an abnormality in the inflation system 11B without the need to remove the entire intracorporeal insertion tube 11 from the packaging bag 14 (more specifically, without the need to open the packaging bag 14).

[Third embodiment]
A third embodiment of the intracorporeal insertion tube set of the present invention will now be described.
Except for the points described below, the intracorporeal insertion tube set 1 of the third embodiment is configured similarly to the intracorporeal insertion tube set 1 of the above-mentioned first embodiment. Therefore, the intracorporeal insertion tube set 1 of the third embodiment can provide the same effects as the intracorporeal insertion tube set 1 of the above-mentioned first embodiment, except for the points described below.

FIG. 7 is a diagram showing an example of the configuration of the intracorporeal insertion tube set 1 according to the third embodiment.
In the example shown in FIG. 7, the intracorporeal insertion tube set 1 includes an intracorporeal insertion tube 11 configured similarly to the examples shown in FIGS. 1 and 2(A), a lubricant containing bag 12, a lubricant 13, and a packaging bag 14.
The lubricant containing bag 12 is a bag that contains a lubricant 13. The lubricant 13 is any known medical lubricant, such as KY (registered trademark) Jelly.
The packaging bag 14 contains the internal insertion tube 11 and the lubricant containing bag 12 in, for example, a sterilized state.

FIG. 8 is an exploded perspective view of the packaging bag 14 for illustrating an example of a method for housing the internal insertion tube 11 and the lubricant containing bag 12 shown in FIG.
In the example shown in FIG. 8, the packaging bag 14 includes a first sheet 14-1 and a second sheet 14-2.
The first sheet 14-1 has an outer peripheral portion 14-1A and a non-outer peripheral portion. The non-outer peripheral portion of the first sheet 14-1 includes a bonding portion 14-1B.
The second sheet 14-2 has an outer peripheral portion 14-2A and a non-outer peripheral portion. The non-outer peripheral portion of the second sheet 14-2 includes a bonding portion 14-2B.

7 and 8, when the internal insertion tube 11 and the lubricant containing bag 12 are contained in the packaging bag 14, the internal insertion tube 11 and the lubricant containing bag 12 are disposed between the first sheet 14-1 and the second sheet 14-2. That is, the internal insertion tube 11 and the lubricant containing bag 12 are disposed below the first sheet 14-1 in Fig. 8 and above the second sheet 14-2 in Fig. 8.
Next, the outer peripheral portion 14-1A of the first sheet 14-1 and the outer peripheral portion 14-2A of the second sheet 14-2 are joined by any known method such as welding, and the joining portion 14-1B of the first sheet 14-1 and the joining portion 14-2B of the second sheet 14-2 are joined by a similar method. The lubricant containing bag 12 is joined by a similar method to at least one of a part of the non-outer peripheral portion of the first sheet 14-1 and a part of the non-outer peripheral portion of the second sheet 14-2. As a result, the internal insertion tube 11 and the lubricant containing bag 12 are housed in the packaging bag 14 (as shown in FIG. 7).

In the example shown in FIGS. 7 and 8, when the internal insertion tube 11 and the lubricant containing bag 12 are contained in the packaging bag 14 as shown in FIG. 7, the positioning portion 14A is located between the tube main body 11A and the pilot balloon 11B3 of the inflation system 11B.
Therefore, in the example shown in FIGS. 7 and 8, similarly to the example shown in FIGS. 1 to 3, when a user of the intracorporeal insertion tube set 1 removes the intracorporeal insertion tube 11 from the packaging bag 14, it is possible to prevent the pilot balloon 11B3 from moving to the side of the tip portion 11A1 of the intracorporeal insertion tube 11 (the left side in FIG. 7).
7 and 8, the user of the intracorporeal insertion tube set 1 does not need to remove the entire intracorporeal insertion tube 11 from the packaging bag 14 in order to check for the presence or absence of an abnormality in the inflation system 11B.

In the intracorporeal insertion tube set 1 shown in Fig. 7, a lubricant-containing bag 12 (see Fig. 8) is contained in a packaging bag 14. In addition, the lubricant-containing bag 12 is fixed to the packaging bag 14. In detail, as shown in Fig. 7, the lubricant-containing bag 12 that contains the lubricant 13 is disposed adjacent to the cuff 11B1 of the intracorporeal insertion tube 11. In addition, the strength of the lubricant-containing bag 12 is set to a value lower than the strength of the packaging bag 14.
7 and 8, when the intracorporeal insertion tube set 1 is used, the lubricant containing bag 12 is pressurized by a user of the intracorporeal insertion tube set 1, such as a paramedic. As a result, the lubricant containing bag 12 is broken, and the lubricant 13 contained in the lubricant containing bag 12 is applied to the cuff 11B1 of the intracorporeal insertion tube 11.
On the other hand, even if the lubricant-containing bag 12 is pressurized, the packaging bag 14 that contains the internal insertion tube 11 and the lubricant-containing bag 12 is not broken. As a result, the lubricant 13 is applied to the cuff 11B1 inside the packaging bag 14.
Therefore, in the example shown in FIGS. 7 and 8 , a user of the intracorporeal insertion tube set 1, such as a paramedic, can remove the intracorporeal insertion tube 11 from the packaging bag 14 in a state in which the lubricant 13 is applied to the cuff 11B1.

In other words, the internal insertion tube set 1 shown in FIG. 7 includes a lubricant containing bag 12 that contains the lubricant 13 to be supplied to the cuff 11B1. The lubricant 13 is supplied to the cuff 11B1 while the internal insertion tube 11 is contained in the packaging bag 14.

In the example shown in Figures 1 to 8, the internal insertion tube 11 without a stylet (not shown) inserted therein is contained in the packaging bag 14, but in other examples, the internal insertion tube 11 with a stylet (not shown) inserted therein may be contained in the packaging bag 14.

In the example shown in FIGS. 7 and 8, a stylet (not shown) is not contained in the packaging bag 14.
In another example, a stylet (not shown) may be contained in the packaging bag 14. In a first example in which a stylet is contained in the packaging bag 14, the stylet is contained in the packaging bag 14 in a state in which it is inserted into the internal insertion tube 11.
In a second example in which the stylet is contained in the packaging bag 14, the stylet is contained in the packaging bag 14 without being inserted into the internal insertion tube 11. In this example, when the lubricant containing bag 12 is broken and the lubricant 13 contained in the lubricant containing bag 12 is applied to the cuff 11B1 of the internal insertion tube 11, the lubricant 13 contained in the lubricant containing bag 12 is also applied to the stylet. In other words, with the internal insertion tube 11 and the stylet contained in the packaging bag 14, the lubricant 13 is supplied to the cuff 11B1 and the stylet.
In this example, the internal insertion tube 11 is taken out from one end of the packaging bag 14 (the end on the right side in FIG. 7), and the stylet is taken out from the other end of the packaging bag 14 (the end on the left side in FIG. 7, i.e., the end closer to the lubricant containing bag 12). This allows the lubricant 13 to be applied to the entire stylet. Preferably, the stylet contained in the packaging bag 14 is made of a low-friction material such as FEP (tetrafluoroethylene-hexafluoropropylene copolymer).

<Example>
The present inventors have carried out a study to compare the time required for preparation for tracheal intubation using a conventional tracheal intubation tube and the intracorporeal insertion tube set of the third embodiment.
When the intracorporeal insertion tube set of the third embodiment is used, the time required for preparation for tracheal intubation can be shortened compared to when a conventional tracheal intubation tube is used, and the variation in the time required for each user of the intracorporeal insertion tube set (tracheal intubation tube) can be reduced. The effectiveness of the intracorporeal insertion tube set of the third embodiment has become clear in the study conducted by the present inventor.
In a study conducted by the present inventor, ten in-service paramedics (from fire department ambulances) used a conventional tracheal intubation tube and the internal insertion tube set of the third embodiment, and measured the time required from the start of inspection operations (checking for damage to the cuff, applying lubricant, etc.) before tracheal intubation to the time when the internal insertion tube 11 (tracheal intubation tube) was removed from the packaging bag 14 (package).
The statistical test used for comparison in the study conducted by the present inventors was the "paired-t test."

The average age of the 10 currently employed (fire department emergency medical technicians) was 39.8 years old and the average gender was male.
The time required for the conventional tracheal intubation was 81.1 seconds, with a standard deviation of 12.4 seconds. 95% of the subjects completed the procedure between 56.3 and 165.9 seconds.
On the other hand, the time required for setting the internal insertion tube in the third embodiment was 47.0 seconds, with a standard deviation of 5.8 seconds. 95% of the subjects completed the operation within 35.4 to 58.6 seconds.
The results indicate a statistically significant difference.

The difference in time required between the conventional tracheal intubation tube and the third embodiment of the internal insertion tube set was 34.1 seconds (95% confidence interval) (shortest 23.8 seconds, longest 44.4 seconds).

<Application Examples>
In the first application example, the intracorporeal insertion tube set 1 of the first to third embodiments is applied to tracheal intubation. In detail, in the first application example, the intracorporeal insertion tube 11 is used as a tracheal tube, and the cuff 11B1 of the intracorporeal insertion tube 11 is used as a cuff disposed in the trachea.
In the second application example, the intracorporeal insertion tube set 1 of the first to third embodiments is applied to tracheal intubation, similarly to the first application example. In detail, in the second application example, the cuff 11B1 of the intracorporeal insertion tube 11 is used as an esophageal cuff.
In the third application example, the intracorporeal insertion tube set 1 according to the first to third embodiments is applied to a colonoscopic examination. In detail, in the third application example, the cuff 11B1 of the intracorporeal insertion tube 11 is used as an endo-cuff.

Although an embodiment of the present invention has been described above in detail with reference to the drawings, the specific configuration is not limited to this embodiment, and appropriate modifications can be made without departing from the spirit of the present invention. The configurations described in each of the above-mentioned embodiments may be combined.

1...Internal insertion tube set, 11...Internal insertion tube, 11A...Tube body, 11A1...Tip, 11A2...Base, 11B...Inflation system, 11B1...Cuff, 11B2...Inflation line, 11B3...Pilot balloon, 12...Lubricant storage bag, 13...Lubricant, 14...Packaging bag, 14A...Positioning section, 14B...Valve section, 14B1...Through hole, DB...Depth dimension, 14-1...First sheet, 14-1A...Outer periphery, 14-1B...Joint, 14-2...Second sheet, 14-2A...Outer periphery, 14-2B...Joint, SY...Syringe, SY1...Tip, LS...Length dimension

Claims (7)

an intracorporeal insertion tube having a tube body and an inflation system;
and a packaging bag for housing the internal insertion tube,
The tube body includes a distal end and a proximal end disposed opposite the distal end,
The inflation system includes a cuff, an inflation line extending from the cuff, and a pilot balloon disposed on an opposite side of the cuff across the inflation line;
The packaging bag is
a positioning portion for positioning the base end portion and the pilot balloon adjacent to each other in a state in which the internal insertion tube is contained in the packaging bag ,
The packaging bag is formed by joining a first outer periphery that is an outer periphery of a first sheet and a second outer periphery that is an outer periphery of a second sheet,
the positioning portion is configured by joining a first joint portion that is a part of the non-peripheral portion of the first sheet and a second joint portion that is a part of the non-peripheral portion of the second sheet,
the positioning portion is positioned between the tube main body and the pilot balloon in a state in which the internal insertion tube is contained in the packaging bag . the packaging bag includes a valve portion disposed adjacent to the pilot balloon,
The valve portion has a through hole configured to allow a tip end of a syringe that supplies air to the pilot balloon to be inserted and removed.
The intracorporeal insertion tube set according to claim 1 . The depth dimension of the through hole is smaller than the length dimension of the tip portion.
The intracorporeal insertion tube set according to claim 2 . The cuff further includes a lubricant storage bag in which a lubricant to be supplied to the cuff is stored.
The lubricant-containing bag is fixed to the packaging bag,
The lubricant is supplied to the cuff in a state in which the internal insertion tube is contained in the packaging bag.
The intracorporeal insertion tube set according to claim 1 . The strength of the lubricant storage bag is lower than the strength of the packaging bag.
5. The intracorporeal insertion tube set according to claim 4 . The stylet further includes a stylet that is contained in the packaging bag in a state where the stylet is not inserted into the internal insertion tube,
The lubricant is supplied to the cuff and the stylet in a state in which the internal insertion tube and the stylet are contained in the packaging bag.
The intracorporeal insertion tube set according to claim 4 . the internal insertion tube is removed from one end of the packaging bag, and the stylet is removed from the other end of the packaging bag.
The intracorporeal insertion tube set according to claim 6 .

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