JP7424046B2 - medical suction device - Google Patents

Description

TECHNICAL FIELD The present invention relates to a medical suction device.

As a medical suction device, for example, there is a medical suction device described in Patent Document 1.
The medical suction device of Patent Document 1 is a medical suction device that suctions drainage fluid using negative pressure, and includes:
A negative pressure container that generates negative pressure inside, an exhaust part that is connected to the negative pressure container and exhausts air to the outside, a storage part that stores drained liquid, and a balloon that is placed inside the negative pressure container. It is configured with the following.

Japanese Patent Application Publication No. 2006-102486

According to studies by the inventor of the present application, there is room for improvement in the structure of the medical suction device of Patent Document 1 from the viewpoint of suctioning waste fluid with good reproducibility.

The present invention has been made in view of the above-mentioned problems, and provides a medical suction device having a structure capable of suctioning waste fluid with good reproducibility.

According to the present invention, there is provided a medical suction device that suctions drainage fluid using negative pressure,
negative pressure container,
an exhaust section connected to the negative pressure container, which exhausts air from the inside to the outside when contracted by a squeezing operation, and sucks air from the negative pressure container when elastically restored;
a balloon arranged in the negative pressure container and elongated in the axial direction;
Equipped with
The inside of the balloon communicates with the outside air through pores formed in the negative pressure container,
The balloon expands as the negative pressure container becomes negative pressure,
Changes in dimensions of the balloon in the axial direction between before and after inflation/deflation when the balloon is inflated to the maximum once and deflated in the negative pressure container, and with respect to the axial direction of the balloon Provided is a medical suction instrument in which at least one of the dimensional change in the orthogonal width direction is less than 1.0%.

According to the present invention, the medical suction instrument can aspirate waste fluid with good reproducibility.

FIG. 2 is a front view of the medical suction instrument according to the present embodiment, showing a state in which the balloon is not inflated. FIG. 2 is a front view of the medical suction instrument according to the present embodiment, showing a state in which the balloon is inflated to its maximum. FIGS. 3A and 3B are schematic diagrams of balloons in Examples and Comparative Examples. FIGS. 4(a) and 4(b) show changes in each dimension of the balloon before and after inflation/deflation in the example. 5(a) and 5(b) show changes in each dimension of the balloon before and after inflation/deflation in a comparative example. FIGS. 6(a) and 6(b) are line graphs showing changes in each dimension of the balloon before and after inflation/deflation in the example. 7(a) and 7(b) are line graphs showing changes in each dimension of the balloon before and after inflation/deflation in the comparative example.

Embodiments of the present invention will be described below using FIGS. 1 and 2. In addition, in all the drawings, the same reference numerals are given to the same components, and the explanation is omitted as appropriate.

As shown in FIGS. 1 and 2, the medical suction device 100 according to the present embodiment is a medical suction device 100 that suctions waste fluid using negative pressure, and includes a negative pressure container 10 and a negative pressure container 10. It is connected to an exhaust section 20 that exhausts air from the inside to the outside when contracted by a squeezing operation and sucks air from the negative pressure container 10 when elastically restored. A long balloon 30 is provided.
The inside of the balloon 30 communicates with the outside air through pores (not shown) formed in the negative pressure container 10, and as the negative pressure container 10 becomes negative pressure, the balloon 30 expands. In addition, when the balloon 30 is inflated once to the maximum in the negative pressure container 10 and then deflated, the change in the dimension of the balloon 30 in the axial direction before and after inflation/deflation, and the change in the dimension in the axial direction of the balloon 30 At least one of the dimensional change in the orthogonal width direction is less than 1.0%.

Here, in the following explanation, when the balloon 30 is inflated to the maximum, as shown in FIG. ) means to expand the negative pressure container 10 until it can no longer expand. Furthermore, deflation of the balloon 30 means that the balloon 30 returns to its natural shape, which is not an inflated state, that is, a substantially cylindrical shape as shown in FIG.
Furthermore, a series of operations in which the exhaust section 20 is contracted by a squeezing operation and then the squeezing operation on the exhaust section 20 is released to elastically restore the exhaust section 20 to its natural state is referred to as a pumping operation.

In the case of this embodiment, the inside of the negative pressure container 10 gradually becomes negative pressure by repeating the pumping operation on the exhaust part 20 while the inflow of air into the inside of the negative pressure container 10 is restricted. Further, as the inside of the negative pressure container 10 becomes negative pressure, outside air is sucked into the inside of the balloon 30 through the above-mentioned pores, and the balloon 30 expands. When the restriction on the inflow of air into the negative pressure container 10 is lifted while the balloon 30 is inflated, a suction force is generated inside the negative pressure container 10, and the medical suction device 100 is discharged. Start suctioning the liquid.
Then, when the pressure inside the negative pressure container 10 gradually returns to atmospheric pressure due to suction of the drained liquid by the medical suction device 100, the balloon 30 gradually deflates and the suction force also gradually decreases. Then, when the balloon 30 is completely deflated (when the balloon 30 is restored to its natural state), suction of the drained liquid is stopped.
After the suction of the drained liquid has stopped, as described above, the pumping operation on the exhaust part 20 is repeated, and the inside of the negative pressure container 10 is made negative pressure, and the balloon 30 is inflated, so that the medical suction device 100 is discharged again. Can aspirate liquid.

According to this embodiment, the change in dimensions of the balloon 30 before and after inflation/deflation, that is, the tensile permanent strain produced in the balloon 30 due to inflation, is perpendicular to the axial direction of the balloon 30 or the axial direction of the balloon 30. It is less than 1.0% in at least one of the width directions. Therefore, even if the operation of inflating/deflating the balloon 30 is repeated multiple times, the balloon 30 inflates/deflates stably each time, so the medical suction instrument 100 can aspirate waste fluid with good reproducibility.

In the following description, it is assumed that the downward direction in FIG. 1 is the downward direction, and the upward direction is the upward direction. That is, the downward direction (downward) is the direction of gravity when the bottom of the medical suction device 100 is placed on a horizontal placement surface and the medical suction device 100 stands on its own. Also, the front side of the medical suction device 100 (the near side of the page in FIG. 1) is referred to as the front, the back side of the medical suction device 100 (the back side of the page in FIG. 1) is referred to as the rear, and the right side in FIG. 1 is the right side. On the other hand, the left side in FIG. 1 is called the left side. However, these directions are for convenience and do not limit the directions when manufacturing or using the medical suction instrument 100.

The medical suction device 100 according to the present embodiment suctions drained fluids such as blood and exudate from a wound in a human body, for example, via a suction tube 110 (see FIGS. 1 and 2) that is placed in the body.

As shown in FIG. 1, the medical suction device 100 includes, for example, a container body 11, a cap member 40 to which a balloon 30 is attached, and a liquid collection port 52 connected to a suction tube 110. There is.
In the case of this embodiment, the negative pressure container 10 is constituted by a container body 11.
The container body 11 is, for example, a box-shaped container in which the front and back dimensions are smaller than the width dimensions. The container body 11 includes a horizontally arranged top and bottom, a pair of vertically arranged left and right side walls, and a vertically arranged front and rear walls.
The container body 11 further includes, for example, a mouth and neck part 12. The mouth and neck portion 12 is, for example, formed in a cylindrical shape with the vertical direction as the axial direction, and communicates the outside with the inside of the container body 11 (negative pressure container 10). The upper end of the mouth and neck part 12 is open to the outside, and the lower end of the mouth and neck part 12 is open to the inside of the container body 11. By detachably attaching the cap member 40 to the mouth and neck portion 12, the opening on the upper end side of the mouth and neck portion 12 is closed.
The mouth and neck part 12 is arranged, for example, at the center of the top of the container body 11. However, the position where the mouth and neck part 12 is arranged is not limited to this, and the mouth and neck part 12 may be arranged at one end of the top of the container body 11, for example.

In the case of this embodiment, the internal space of the container main body 11 constitutes the storage section 15 that stores the sucked waste liquid. That is, the sucked drainage liquid is stored inside the negative pressure container 10.
Here, the opening on the upper end side of the mouth and neck portion 12 also has the role of, for example, a discharge port for discharging the liquid contained in the storage portion 15 to the outside. After suction of the drained liquid is completed, the cap member 40 can be removed from the mouth and neck section 12, and the drained liquid can be discharged from the discharge port (opening on the upper end side of the mouth and neck section 12).
In addition, in the medical suction device 100, a discharge port may be provided separately from the opening on the upper end side of the mouth and neck portion 12. In this case, the container main body 11 has, for example, a cylindrical second neck part (not shown) that communicates the outside with the inside of the container main body 11, and the upper end side of the second neck part The opening may constitute a discharge port. In this case, it is preferable that the second neck part is arranged near the corner of the top of the container body 11. Further, in this case, the negative pressure container 10 includes a second cap member (not shown) that is detachably attached to the second mouth and neck.

The container body 11 is made of, for example, a transparent (transparent to visible light) resin material. Transparent resin materials include, but are not particularly limited to, hard vinyl chloride resins, polyester resins such as polyethylene terephthalate, styrene resins such as acrylonitrile-styrene copolymer resins, and polyolefins such as polypropylene (PP) and PE. Examples include resins.

Further, the container body 11 may be provided with a scale (not shown) so that the amount of drained liquid sucked into the interior of the container body 11 (accommodating portion 15) can be confirmed.

The volume of the container body 11 (negative pressure container 10) is not particularly limited, but is preferably, for example, 100 ml or more and 500 ml or less.

The cap member 40 includes, for example, an attachment part 41 that is detachably attached to the mouth and neck part 12, and a cylindrical part 42 to which the balloon 30 is attached.
The mounting portion 41 has a closed opening on the upper end side and is formed in a cylindrical shape with the vertical direction as the axial direction. The attachment part 41 is detachably attached to the mouth and neck part 12 by a fastening method such as screwing.
The cylindrical part 42 protrudes downward from the upper part of the mounting part 41, and is formed in a cylindrical shape having a diameter smaller than that of the mounting part 41, for example. The cylindrical part 42 and the mounting part 41 are arranged coaxially with each other. The lower end of the cylindrical part 42 is arranged below the lower end of the mounting part 41.

The balloon 30 is, for example, formed into a substantially cylindrical shape with the vertical direction as the axial direction. The inner diameter and outer diameter of the balloon 30 are substantially constant regardless of the position in the axial direction.
The lower end of the balloon 30 is closed and has a downwardly convex hemispherical shape. The upper end of the balloon 30 is open, and the cylindrical part 42 is inserted through the opening, and the balloon 30 is airtightly attached to the cylindrical part 42.
Here, a flange portion 42a projecting outward is formed at the upper end portion of the cylindrical portion 42. The state in which the balloon 30 is attached to the cylindrical portion 42 is maintained in a good manner by the flange portion 42a. Furthermore, the balloon 30 has a fixing part 32 that fixes the upper end of the balloon 30 to the cap member 40, for example. The fixing part 32 is disposed in close contact with the upper end of the cylindrical part 42 and the upper end of the balloon 30 so as to circumferentially surround each of them.
The fixing portion 32 is made of, for example, a hard resin material. Therefore, when the inside of the negative pressure container 10 becomes negative pressure and the balloon 30 expands, the portion of the balloon 30 below the lower end of the fixing portion 32 (the portion that is not in close contact with the fixing portion 32) is substantially Expand.

Further, the above-mentioned pore is formed in the center of the upper part of the mounting part 41, which communicates the inside of the balloon with the outside air. When the negative pressure container 10 becomes negative pressure, air is sucked into the negative pressure container 10 through the pores, and the sucked air flows into the balloon 30 through the cylindrical portion 42 . This causes the balloon 30 to expand.

In the case of this embodiment, the balloon 30 is disposed inside the negative pressure container 10 by attaching the cap member 40 to the mouth and neck region 12 . More specifically, when the cap member 40 is attached to the mouth and neck part 12, for example, the cylindrical part 42 is inserted into the inner cavity of the mouth and neck part 12 and is arranged inside the negative pressure container 10. ing. Therefore, the balloon 30 attached to the cylindrical part 42 is also inserted into the inner cavity of the mouth and neck part 12 and is arranged inside the negative pressure container 10.

The balloon 30 is made of an elastic material that can be expanded and deflated. Materials for the balloon 30 include, for example, rubber materials such as natural rubber, isoprene rubber, and chloroprene rubber, styrene-based thermoplastic elastomers such as styrene-butadiene copolymers, styrene-isoprene copolymers, olefin-based thermoplastic elastomers, and amide-based thermoplastic elastomers. Thermoplastic elastomer materials such as elastomers and polyester elastomers are preferred.
The hardness (JIS hardness) of the material of the balloon 30 is not particularly limited, but is preferably, for example, 20 degrees or more and 50 degrees or less. In the case of this embodiment, the hardness of the material forming the balloon 30 is, for example, about 30 degrees. Here, the JIS hardness is a value measured using a durometer defined in JIS K 6253 as a measuring instrument.
The thickness of the balloon 30 is not particularly limited, but is preferably, for example, 0.2 mm or more and 0.6 mm or less. In the case of this embodiment, the wall thickness of the balloon 30 is, for example, approximately 0.4 mm.
The longitudinal dimension of the balloon 30 is, for example, 40 mm or more and 80 mm or less, and the radial dimension perpendicular to the longitudinal direction is, for example, 15 mm or more and 30 mm or less.

When the balloon 30 is inflated, further expansion of the balloon 30 is regulated by the inner surface of the container body 11, so that the balloon 30 is inflated into a shape that conforms to the inner surface of the container body 11, and (See Figure 2). More specifically, for example, when the balloon 30 is inflated to its maximum, the balloon 30 is located at a portion of the container body 11 excluding eight corners (corners), a portion where the mouth and neck portion 12 are formed, and an exhaust portion. 20 and the connection part with the liquid collecting port 52.

The liquid collection port 52 is, for example, formed in a substantially cylindrical shape that projects upward from the top of the container body 11. The liquid collection port 52 is arranged, for example, on the left side of the mouth and neck 12.
The liquid collection port 52 communicates the inside and outside of the container body 11 (negative pressure container 10). For example, a suction tube 110 is attached to the upper end of the liquid collection port 52. The suction tube 110 is, for example, a long tubular member, and the end opposite to the side connected to the liquid collection port 52 is left in the body. The drained liquid passes through, for example, the inner cavity of the suction tube and the inner cavity of the liquid collection port 52, and is sucked into the interior of the container body 11 (accommodating portion 15).
The portion below the upper end of the liquid collection port 52 is made of, for example, a flexible resin material. The upper end of the liquid collection port 52 is made of, for example, a hard resin material.

Furthermore, a clamp member 53 is attached to the liquid collection port 52, for example.
The clamp member 53 is, for example, formed in a plate shape that is elongated in one direction. A slit (not shown) extending in the longitudinal direction of the clamp member 53 is formed. A liquid collection port 52 is inserted through this slit, and the clamp member 53 is held by the liquid collection port 52. Further, the clamp member 53 is attached to a portion below the upper end of the liquid collection port 52 (a relatively flexible portion of the liquid collection port 52).
A part of the slit of the clamp member 53 is a relatively wide wide part, and the remaining part of the slit is a relatively narrow part. The wide portion and the narrow portion are arranged continuously with each other.
By sliding the clamp member 53 relative to the liquid collection port 52 so that the liquid collection port 52 passes through the wide part of the slit, the flow path inside the liquid collection port 52 is opened, and the liquid collection port The inside of 52 communicates with the internal space of negative pressure container 10 .
By sliding the clamp member 53 relative to the liquid collection port 52 so that the liquid collection port 52 passes through the narrow part of the slit, the liquid collection port 52 is tightened by the clamp member 53 and the liquid collection port 52 is closed. The internal flow path is closed, and the internal space of the negative pressure container 10 is closed from the outside.

The exhaust section 20 is, for example, a hollow, spherical exhaust pump. The exhaust section 20 is disposed, for example, on the right side of the mouth and neck section 12 at the top of the container body 11.
Further, the exhaust section 20 includes, for example, a first one-way valve 21 that restricts air from flowing into the inside of the negative pressure container 10, and a first one-way valve 21 that restricts air from flowing into the inside of the exhaust section 20. A second one-way valve 22 is provided. The first one-way valve 21 is provided at the boundary between the negative pressure vessel 10 and the exhaust section 20, and the second one-way valve is provided at the boundary between the exhaust section 20 and the external space.
When a squeezing operation is performed on the exhaust section 20, the air inside the exhaust section 20 is discharged to the outside without flowing into the inside of the negative pressure container 10.
When the squeezing operation on the exhaust section 20 is released, the exhaust section 20 returns to its natural shape, that is, the spherical shape, due to the elastic restoring force. At this time, the exhaust section 20 sucks the air inside the negative pressure container 10. When these operations, that is, the above-mentioned pumping operation, are repeated multiple times, the air inside the negative pressure container 10 is exhausted to the outside through the first one-way valve 21, the exhaust part 20, and the second one-way valve 22, The inside of the negative pressure container 10 becomes negative pressure.
The material of the exhaust section 20 is not particularly limited, and may be, for example, natural rubber, or synthetic rubber such as isoprene rubber or silicone rubber.

In the case of this embodiment, the body fluid inlet at the top of the container body 11 (the part communicating with the liquid collection port 52), the exhaust port of the exhaust part 20 (the boundary between the negative pressure container 10 and the exhaust part 20) It is also preferable that grooves (not shown) are formed on the inner surface of the container body 11 around the body fluid inlet and the exhaust port in order to prevent the balloon 30 from clogging the body fluid inlet and outlet. It is preferable that this groove surrounds, for example, the body fluid inlet or the exhaust port in a circumferential manner.
Further, it is also preferable that the liquid collection port 52 is arranged near the corner of the container body 11. When the balloon 30 is deflated, the first place where a gap is created between the balloon 30 and the inner surface of the container body 11 is near the corner of the container body 11. If the container has two necks, by providing the liquid collection port 52 near the second neck, it is possible to easily secure a space for the drained liquid to enter the container body 11 from the start of the suction operation. be able to.
Note that it is more preferable that grooves be formed around the body fluid inlet and the exhaust port, and that the liquid collection port 52 be arranged near the corner of the container body 11.

In the case of this embodiment, the pumping operation for the exhaust section 20 is performed multiple times while the flow path inside the liquid collection port 52 is in a closed state and the mouth and neck section 12 is closed by the cap member 40. By doing so, the inside of the negative pressure container 10 becomes negative pressure, and the balloon 30 is inflated.
Then, when the flow path inside the liquid collection port 52 is opened, the balloon 30 contracts and a suction force is generated, and the drained liquid is sucked into the storage part 15 from the suction tube through the liquid collection port 52. Ru. As the balloon 30 deflates, the suction force decreases, and when the balloon 30 stops deflating (when the balloon 30 returns to its natural state), the suction of the drained fluid by the medical suction device 100 also stops.

Here, in the case of this embodiment, the change in dimension of the balloon 30 in the axial direction between before and after inflation/deflation is less than 0.5%.
More specifically, the change in the axial dimension of the balloon 30 in its natural state after the first inflation/deflation with respect to the axial dimension of the balloon 30 in its natural state before the first inflation/deflation is Less than 0.5%. Even after the second and subsequent inflation/deflation, the dimensional change in the axial direction of the balloon 30 is less than 0.5%.
Thereby, it is possible to suppress the difference between the rate of variation in the suction force caused by the second and subsequent inflation/deflation of the balloon 30 and the rate of variation in the suction force caused by the first inflation/deflation of the balloon 30. That is, the medical suction device 100 can suction the drained liquid with good reproducibility.

Furthermore, in the case of this embodiment, when the balloon 30 is repeatedly inflated and deflated three times, the dimension in the width direction after the second and subsequent deflation is the same as the dimension in the width direction after the first deflation. It is within ±10%.
More specifically, when the dimension in the width direction of the balloon 30 in its natural state after the first inflation/deflation is taken as 100%, the dimension in the width direction of the balloon 30 in its natural state after the second and subsequent inflations/deflations is 100%. The dimensions are 90% or more and 110% or less.
As a result, even when the balloon 30 is inflated/deflated for the second time or later, the balloon 30 is inflated/deflated stably each time, so that the medical suction instrument 100 can aspirate waste fluid with better reproducibility.

The balloon 30 in this embodiment is obtained, for example, by subjecting it to a conditioning process as described below.

First, the balloon 30 is severely inflated once by introducing air into the balloon 30 outside the negative pressure container 10, that is, under atmospheric pressure and in an environment where expansion is not restricted by the inner wall of the negative pressure container 10. Note that severe inflation here refers to inflating the balloon 30 so that the diameter of the balloon 30 is about 4 to 5 times the normal size and the longitudinal dimension of the balloon 30 is about 2 to 3 times the normal size. It means to do something. Further, the volume of the severely inflated balloon 30 is, for example, approximately twice as large as the internal volume of the negative pressure container 10.
After the balloon 30 is left in the severely inflated state for about 1 minute, the balloon 30 is deflated (restored to its natural state).
Next, with the balloon 30 disposed inside the negative pressure container 10, the inside of the negative pressure container 10 is made negative pressure to inflate the balloon 30 once to the maximum. After the balloon 30 is left in the maximum inflated state for one minute, the balloon 30 is deflated (restored to its natural state).
Note that it is preferable that the balloon 30 be left for about 24 hours after being severely inflated and before being maximally inflated.
In this way, the balloon 30 in this embodiment is obtained.

Although the embodiments have been described above with reference to the drawings, these are merely examples of the present invention, and various configurations other than those described above may also be adopted.

For example, in the above description, an example in which the negative pressure container 10 has the accommodating section 15 has been described, but the present invention is not limited to this example, and the accommodating section 15 for accommodating drainage liquid and the negative pressure container 10 are provided in separate containers. may be configured. That is, the medical suction device 100 includes, for example, a negative pressure container 10, a storage container (not shown) having a storage section 15 for storing waste fluid sucked by the negative pressure container 10, and the inside of the negative pressure container 10. A connecting tube (not shown) communicating with the inside of the storage container may be provided.
In this case, the negative pressure container 10 includes a balloon 30 and an exhaust section 20, and the storage container includes a liquid collection port 52 and a clamp member 53. When a pumping operation is performed on the exhaust section 20, the inside of the negative pressure container 10 becomes negative pressure, and the inside of the storage container connected via the connecting tube also becomes negative pressure. Then, by opening the clamp member 53, the drained liquid is sucked into the interior of the storage container (accommodation section 15) via the liquid collection port 52.

This embodiment includes the following technical ideas.
(1) A medical suction device that suctions drainage fluid using negative pressure,
negative pressure container,
an exhaust section connected to the negative pressure container, which exhausts air from the inside to the outside when contracted by a squeezing operation, and sucks air from the negative pressure container when elastically restored;
a balloon arranged in the negative pressure container and elongated in the axial direction;
Equipped with
The inside of the balloon communicates with the outside air through pores formed in the negative pressure container,
The balloon expands as the negative pressure container becomes negative pressure,
Changes in dimensions of the balloon in the axial direction between before and after inflation/deflation when the balloon is inflated to the maximum once and deflated in the negative pressure container, and with respect to the axial direction of the balloon A medical suction device in which at least one of the change in dimension in the orthogonal width direction is less than 1.0%.
(2) The medical suction device according to (1), wherein a change in dimension of the balloon in the axial direction between before and after the inflation/deflation is less than 0.5%.
(3) When the balloon is repeatedly inflated and deflated three times, the dimension in the width direction after the second and subsequent deflation is ± with respect to the dimension in the width direction after the first deflation. The medical suction device according to (1) or (2), which is within 10%.

Examples and comparative examples will be described below using FIGS. 3(a) to 7(b).

In Examples and Comparative Examples, using the balloons described below, the balloon was inflated to its maximum value in a negative pressure container and then deflated three times, and the temperature of the balloon was measured between before and after each inflation/deflation. Changes in each dimension were evaluated. Each series of balloon inflation/deflation operations was performed at 5-10 minute intervals. In addition, each dimension of the balloon here means the dimension L1, the dimension L2, the dimension L3, and the dimension L4 shown in FIG. 3(a) and FIG. 3(b), respectively. More specifically, the dimension L1 is a dimension of a portion of the balloon in the axial direction, and the dimension L2 is a dimension of a portion of the balloon in a direction perpendicular to the axial direction (hereinafter referred to as the width direction). Further, the dimension L3 is a dimension of a portion of the balloon in the radial direction, and the dimension L4 is a dimension of a portion of the balloon in the radial direction and in a direction perpendicular to the dimension L3.
In the example, a medical suction device having a balloon having the structure described in the embodiment was used.
In the comparative example, a medical suction instrument having a balloon that was not subjected to the above-mentioned conditioning treatment was used, compared to the balloon having the structure described in the embodiment.

Among FIGS. 4(a) to 6(b), FIGS. 4(a), 4(b), 6(a), and 6(b) correspond to the example, and FIG. a), FIG. 4(b), FIG. 6(a), and FIG. 6(b) correspond to the modified example.
More specifically, FIGS. 4(a) and 4(b) show changes in each dimension of the balloon before and after three inflations/deflations in the example, of which FIG. 4(a) Figure 4(b) shows the actual measured value (mm) of each dimension of the balloon, and Figure 4(b) shows the percentage change (%) of each dimension of the balloon after inflation/deflation with respect to each dimension of the balloon before the test. ing.
Similarly, FIGS. 5(a) and 5(b) show changes in each dimension of the balloon before and after three inflations/deflations in the comparative example, of which FIG. Figure 5(b) shows the ratio (%) of change in each dimension of the balloon with respect to each dimension of the balloon before the test.
In addition, FIGS. 6(a) and 6(b) show the changes in each dimension of the balloon before and after three inflations/deflations in the example as line graphs, of which FIG. 6(a) is a graph of the actual measured values (mm) of each dimension of the balloon shown in Fig. 4(a), and Fig. 6(b) is a graph of the change rate (%) of each dimension of the balloon shown in Fig. 4(b). is graphed.
Similarly, FIGS. 7(a) and 7(b) show the changes in each dimension of the balloon before and after three inflations/deflations in the comparative example using line graphs. ) graphs the measured values (mm) of each dimension of the balloon shown in Figure 5(a), and Figure 7(b) graphs the percentage change (%) of each dimension of the balloon shown in Figure 5(b). ) is graphed.
In addition, FIG. 3(a) is a view of the balloon viewed in a direction perpendicular to the axial direction, and FIG. 3(b) is a view of the balloon viewed from the distal end side (the side opposite to the side where the cylindrical part is inserted). It is a figure seen from.

As shown in FIGS. 4(a) and 6(a), in the example, in the actual measurement values (mm) of each dimension of the balloon before and after three inflations/deflations, none of the dimensions L1 to L4 , no large fluctuations in numerical values were observed.
More specifically, as shown in FIGS. 4(b) and 6(b), in the example, the percentage change in each dimension of the balloon before and after three inflations/deflations is It was 0.85% or less, and both were less than 1.0%. The rate of change (%) in the dimension L1 was 0.41% or more and 0.45% or less in each case, and was less than 0.5% in each case. Therefore, it can be estimated that the percentage change in the dimensions of the balloon in the axial direction is also less than 0.5%.
Furthermore, the dimension L2 after the second and subsequent contractions was within ±10% of the dimension L2 after the first contraction. That is, when the dimension L2 after the first shrinkage was taken as 100%, the dimension L2 after the second and subsequent shrinkages were all 90% or more and 110% or less. Therefore, it can be estimated that the percentage change in dimensions in the width direction of the balloon is also within ±10%. Further, the rate of change (%) in each of the dimensions L3 and L4 was 0.09% or less each time, and both were less than 0.2%. Therefore, it can be estimated that the percentage change (%) in the dimensions of the balloon in the radial direction is also less than 0.2%.

On the other hand, as shown in FIGS. 5(a) and 7(a), the actual measured values of each dimension of the balloon (especially the actual measured value of dimension L2) before and after three inflations/deflations were compared with the example. A slight fluctuation in the numerical values was confirmed.
More specifically, as shown in FIGS. 5(b) and 7(b), in the comparative example, the percentage change in each dimension of the balloon before and after three inflations/deflations was It was confirmed that the size was larger compared to the example. More specifically, the rate of change (%) in the dimension L2 among the dimensions of the balloon was 1.21% or more and 1.44% or less, which was significantly greater than 1.0%. In addition, the rate of change (%) in the dimension L1 is 0.96% or more and 1.0% or less, which is a value close to 1.0%, in any case.
These results show that by subjecting a balloon to the conditioning treatment described in the embodiment, it is possible to obtain a balloon with small dimensional changes before and after inflation/deflation, that is, a balloon with small tensile permanent strain caused by inflation. Do you get it.

Furthermore, in Examples and Comparative Examples, the tests described below were conducted, and the amount of fluid sucked by the medical suction device between the time the balloon was inflated to its maximum and the time it was deflated (hereinafter referred to as the amount of fluid sucked) (ml)) was evaluated.
First, three samples of medical suction devices are prepared. A first balloon inflation/deflation is performed for each sample. Next, in any one of the three samples, the strain after the first inflation as shown in Fig. 4(a) or Fig. 5(a) is measured, and then the balloon is inflated/deflated again and the liquid is drained. Aspirate and measure the amount of drained liquid aspirated (ml). Then, for the remaining two samples, the balloon is inflated/deflated a second time without aspirating the drainage liquid. Next, in one of the two samples, the strain after the second inflation as shown in FIG. 4(a) or FIG. 5(a) is measured, and then the balloon is inflated/deflated again and discharged. Aspirate the liquid and measure the amount of drained liquid aspirated (ml). Then, for the remaining sample, the balloon is inflated/deflated for the third time without aspirating the drainage liquid. Finally, for the remaining sample, measure the strain after the third inflation as shown in Figure 4(a) or Figure 5(a), then inflate/deflate the balloon again to suck out the drained liquid. Measure the suction volume (ml). As a result, in a medical suction device, the amount of drained liquid aspirated by the sample after the first balloon inflation/deflation (ml) and the amount of drained liquid sucked by the sample after the second balloon inflation/deflation (ml) are determined. , and the amount of drained liquid (ml) aspirated by the sample after the third balloon inflation/deflation can be measured.

In the example, the amount of drained liquid aspirated (ml) was stable each time (each sample), and no large fluctuations were observed.
More specifically, the ratio (%) of the change in the amount of drained liquid aspirated (ml) by the sample after the second and subsequent expansion/deflation to the amount (ml) of drained liquid sucked by the sample after the first expansion/deflation is: It was less than 0.35%.
On the other hand, in the comparative example, it was confirmed that the amount of drained liquid suctioned (ml) varied greatly each time (each sample) compared to the example.
More specifically, the ratio (%) of the change in the amount of drained liquid aspirated (ml) by the sample after the second and subsequent expansion/deflation to the amount (ml) of drained liquid sucked by the sample after the first expansion/deflation is: It was 0.35% or more.
From these results, it was found that according to the balloon subjected to the conditioning treatment described in the embodiment, the medical suction device can aspirate drainage fluid with good reproducibility at least during the second and subsequent balloon inflations/deflations. .

10 Negative pressure container 11 Container body 12 Mouth and neck part 15 Storage part 20 Exhaust part 21 First one-way valve 22 Second one-way valve 30 Balloon 32 Fixing part 40 Cap member 41 Mounting part 42 Cylindrical part 42a Flange part 50 Bottle cap 52 Liquid collection Port 53 Clamp member 100 Medical suction instrument 110 Suction tube

Claims (3)

A medical suction device that suctions drainage fluid using negative pressure,
negative pressure container,
an exhaust section connected to the negative pressure container, which exhausts air from the inside to the outside when contracted by a squeezing operation, and sucks air from the negative pressure container when elastically restored;
a balloon arranged in the negative pressure container and elongated in the axial direction;
Equipped with
The inside of the balloon communicates with the outside air through pores formed in the negative pressure container,
As the negative pressure container becomes negative pressure, the balloon expands and comes into surface contact with an inner wall surface of the negative pressure container ,
When the balloon is inflated once to a maximum shape along the inner wall surface in the negative pressure container and then deflated, a change in the dimension of the balloon in the axial direction before and after inflation/deflation; A medical suction device in which both the change in dimension in the width direction perpendicular to the axial direction of the balloon is less than 1.0% ,
When the balloon is repeatedly inflated and deflated three times, the dimension in the width direction after the second and subsequent deflation is within ±10% of the dimension in the width direction after the first deflation. A medical suction device. The medical suction device according to claim 1, wherein the dimension of the balloon in the axial direction changes by less than 0.5% between before and after the inflation/deflation. A method for manufacturing a medical suction device that suctions waste fluid using negative pressure, the method comprising:
The medical suction device includes:
negative pressure container,
an exhaust section connected to the negative pressure container, which exhausts air from the inside to the outside when contracted by a squeezing operation, and sucks air from the negative pressure container when elastically restored;
a balloon arranged in the negative pressure container and elongated in the axial direction;
Equipped with
The inside of the balloon communicates with the outside air through pores formed in the negative pressure container, and the balloon expands as the negative pressure in the negative pressure container becomes negative,
The method is
Severely inflating the volume of the balloon to be larger than the internal volume of the negative pressure container by introducing air into the balloon outside the negative pressure container;
With the balloon disposed inside the negative pressure container, the balloon is inflated to the maximum by making the inside of the negative pressure container negative pressure, and the balloon is inflated to a shape along the inner wall surface of the negative pressure container. a step of bringing it into contact;
Equipped with
In the step of maximally expanding,
A method for manufacturing a medical suction device, comprising leaving the balloon in a maximum inflated state inside the negative pressure container, and then deflating the balloon.

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