JP2596518Y2 - Wearable hemostatic device - Google Patents

Description

[Detailed description of the invention]

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a hemostatic device used to compress and stop bleeding that occurs when a catheter inserted into a blood vessel is removed during angiography or the like.

[0002]

2. Description of the Related Art In general, angiographic examination or treatment using a vascular catheter involves making a small incision in the femoral artery and the brachial artery and vein from the body surface, placing the sheath in the blood vessel, and inserting the catheter. It is done by doing. For this reason, if the sheath is removed after the completion of the examination or treatment, a large amount of blood will flow out of the blood vessel opening, and immediately after the removal, the operator will manually compress and stop the bleeding, and then use gauze, bandage, etc. Hemostasis is performed by fixing.

[0003] If the hemostatic portion is tightened or pressed to ensure hemostasis, the peripheral arteries and veins other than the target blood vessel will also be compressed, resulting in impaired hemodynamics on the peripheral side. This causes symptoms such as pain, numbness, coldness, and swelling of the upper limbs in the patient. In addition, if the bleeding site is not sufficiently pressed, rebleeding may occur during compression hemostasis or after the end of the treatment, and the pain given to the patient may be extremely large. In addition, the patient is tied to the bed, usually for 3 hours to overnight, until the hemostasis is completed by pressing and fixing, resulting in great physical and mental pain.

[0004] Various measures have been devised for the situation in the medical field as described above. For example, JP-A-4-4096
Japanese Patent Application Publication No. 4 (Kokai) No. 4 (1993) -214, discloses a hemostatic device in which a support ring that is worn through an upper limb is provided with a presser that moves up and down by a mechanism of a screw, a spring, and an elastic bag in opposition to a hemostatic site. In the case of a commercially available product, the forearm is placed in a U-shaped receiving portion, and a plate-shaped member provided with a presser is placed from above so as to close the U-shape, and the both ends are connected to compress and stop bleeding. There is something. These tools are intended to be worn on a part of the forearm, and have no function to restrain body movement. Therefore, when used for the anterior elbow wedge, which is the insertion site of the cardiovascular catheter, the compressor is likely to deviate from the hemostatic site due to the expansion and contraction of the elbow joint of the patient, causing rebleeding.

In Japanese Utility Model Laid-Open No. 4-11010,
A hemostatic device is disclosed in which a closed hollow body provided with a gas-liquid supply / discharge member and a pressure gauge is provided on a fixed member, and is expanded by supplying a fluid to the hollow body to press the opening of a blood vessel in contact with the hollow body. This hemostatic device employs a use method in which, for example, the fixing plate, which is attached to the tip of an arm fixed to the bedside, is positioned above the bleeding site of the patient lying on the bed and pressed against the patient's body. It is not a model to be attached. Therefore, during compression hemostasis, the patient is restrained at the place where the hemostat is provided, and the body cannot be moved from the specified compression position even on the bed. Although there is a certainty of hemostasis, there is a problem that the pain given to the patient is great.

Further, in Japanese Patent Application Laid-Open No. 64-125262, the movement of the elbow joint is completely restricted by providing a projection comprising a fixing plate and a wrap band and defining a recess for preventing vein compression. In addition, there has been disclosed a hemostatic elbow joint fixator for preventing edema of the arm and concurrent venous thrombosis due to delayed venous blood circulation. By fixing the elbow joint, external force is applied to the coagulated clot at the hemostatic site and it is useful in preventing re-bleeding, and there is a device to prevent venous congestion by tightening and fixing, It is excellent in that it can be walked in the hospital, such as when urinating. However, it is only a tool for fixing the elbow joint, and it is not sufficient as a tool complete with necessary functions as a hemostatic tool.

[0007]

[Problems to be Solved by the Invention] The present invention has been made as a result of various studies in order to solve the above-mentioned problems in the prior art. It is an object of the present invention to provide an effective wearable hemostatic device that can fix the movement of the elbow joint and can easily adjust the pressure without seriously impairing the hemodynamics of the patient.

[0008]

In order to achieve the above object, a wearable hemostatic device according to the present invention is provided with an inflatable and deflated balloon on a central surface and cushioning materials on both surfaces. A fixed plate composed of the hemostatic portion and two fixed portions that are connected and integrated via arms on both sides of the hemostatic portion, and the cushioning material is disposed on the surface, and the distal end of the connection tube is opened in the balloon. It is characterized by comprising a supply / exhaust member, and a fixing band attached to the hemostatic portion and the two fixing portions.

Hereinafter, the present invention will be described in detail with reference to the drawings. FIG. 1 is an external view showing an embodiment of a wearable hemostatic device according to the present invention, FIG. 2 is a top view of a fixing plate, and FIG. 3 is a cross-sectional view taken along the line AA 'in FIG.

As shown in FIG. 1, a fixing plate (20) serving as a skeleton of the hemostatic device according to the present invention is provided on both sides of the hemostatic portion (1).
Each of the two fixed portions (2) is connected and integrated via an arm (3), and the hemostatic portion (1) is for pressing a blood vessel opening for hemostasis. The forearm and the two fixing portions (2) are for fixing the hemostatic portion so as not to shift, and contact the upper arm and the forearm, respectively. At the center of the surface of the hemostatic portion (1), an inflatable and deflateable balloon (12) for pressing the opening of the blood vessel is provided, and a rubber ball (9) having a valve (10) at the rear end is provided. An exhaust device is provided with the connection pipe (8) having a distal end opened in the balloon (12) to expand and contract the balloon. Furthermore, when using this hemostatic device,
In order to ease the contact of the fixation plate with the patient's body (arm), cushions (13, 14) are provided on both sides of the hemostatic balloon (12) and on the surface of the fixation portion (2), respectively.
And to prevent the hemostatic device from slipping,
Fixing bands (4, 5) are attached to the fixing part (2) and the hemostatic part (1), respectively.

The fixing plate (20) comprising the hemostatic part (1), the fixing part (2) and the arm (3) needs sufficient rigidity and strength to fix the bending and stretching movement of the arm mainly composed of the elbow joint. But polycarbonate resin, polystyrene resin,
Using a hard synthetic resin such as a vinyl chloride resin or a polymethylpentene resin, it is relatively easily manufactured by a method such as injection molding, vacuum molding, and sheet processing. Also, stainless steel,
Pipes, plates, rods made of metal materials such as brass and aluminum alloys, and fiber processed products such as cotton, polyester, and nylon, as well as soft materials such as silicone rubber and natural rubber, etc., combined with general medical device materials. Sometimes. However, it is desirable that at least a portion of the hemostatic portion (1) corresponding to the opening of the blood vessel to be subjected to hemostasis has transparency that does not hinder confirmation of the presence or absence of bleeding. It is preferable to use a material having a grade of transparency.

In terms of rigidity and strength of the fixing plate (20),
It is sufficient to use the above-mentioned hard synthetic resin. For example, in the case of a hard vinyl chloride resin, a plate processed product having a wall thickness of 3 mm, a minimum width of the arm (3) of 50 mm, and a total length of 370 mm is sufficient. there were. In addition, the appropriate shape and size of the fixing plate (20) vary depending on the physique of the patient to which the present hemostatic device is worn, but generally, the hemostatic portion (1) has a width of 30 to 1 mm.
The fixed part (2) has a width of 30 to 100 mm and a length of 10 to 80 mm, and has a total length of 100 to 400 mm by connecting and integrating both members with an arm (3). In addition, in order to absorb individual differences in physique, since individual differences tend to appear in the length of the upper arm, the length from the center of the hemostatic part (1) to the end of the fixed part (2) is shorter on the upper arm side. Is preferred. Further, the fixing part (2) and the arm (3) on the upper arm side may have a shape included (integrated) in the hemostatic part body (1).

[0013] Furthermore, the hemostatic device of the present invention can be worn on the body of a patient, and can be used for walking in hospitals, such as during stool.
It is preferable that the weight is light, and the members described below are relatively light. However, it is necessary to reduce the weight of the fixing plate (20), and it is appropriate that the weight is 100 gr or less for adult patients. In addition, in order to be easily attached to the arm, the sectional shape of the fixing plate (20) is an arc shape as shown in FIG.
It is preferable to form a U-shape or a V-shape, and it is desirable that a corner portion in contact with the skin is rounded.

The balloon (12) is made of, for example, natural rubber,
Dipping molding, slash molding, high frequency, heat welding, adhesive bonding of sheet materials using rubbers such as silicone rubber or elastic materials such as soft synthetic resins such as soft vinyl chloride resin, polyethylene resin and EVA resin. A bag that can be easily formed by processing, etc., and generally has a width of 10 to 10.
0 mm, length 30-100 mm, wall thickness 0.01-0.5 mm, withstand pressure 100-300 mmHg. This balloon (12)
Is fixed to the surface of the hemostatic portion (1) of the fixing plate as shown in FIG. 2, but is formed in the form of a bag in advance as described above, and a part of the contact surface of the hemostatic portion (1) of the fixing plate. Alternatively, instead of bonding to the entire surface, the periphery of the elastic sheet may be bonded and fixed to the hemostatic portion (1) to form a closed hollow balloon. The shape may be an ellipse or a circle other than the rectangle as shown in FIG. 2, but it is preferable that the bulge is located slightly inside the center of the front elbow. Further, in addition to the balloon having a flat shape when contracted, a molded body having a peripheral surface thereof and having, for example, a bellows-like fold is also within the scope of the present invention.

The connection pipe (8), which is opened inside the balloon (12) and communicates gas and liquid, is made of a relatively flexible material, for example, the aforementioned rubber or soft synthetic resin, and is integrated with the balloon. Adhesive processing by molding or post-processing, inner diameter 1-8m
m, wall thickness 0.3 to 2 mm, length 50 to 500 mm.
A general tube used for a medical device is sufficient, except that the gas or liquid for inflating the balloon (12) needs to be pressure-resistant so that the lumen is not significantly deformed when injecting or discharging. Further, as shown in FIG. 3, the connecting pipe (8) is guided to the outer surface through the hemostatic part (1) of the fixing plate (20), so that the passage is sandwiched between the cushion (13) and the skin when worn. It is preferable because it is not blocked. It is preferable that a pressure gauge be incorporated in the passage since an operator can easily perform pressure control.

As a supply / exhaust member for inflating and deflating the balloon (12), for example, as shown in FIG. 1, a rubber ball used for inflating a mansent of a sphygmomanometer is used. This rubber ball
When it is compressed and deformed manually and then recovered, the valve (1
0) opens to inhale the outside air, and when compressed again, the valve (1)
0) is closed, the built-in valve near the set screw (11) is opened, air is injected into the balloon (12) through the connecting pipe (8), and the built-in valve is closed. This operation is repeated until the balloon (12) is inflated until a predetermined pressure is obtained.
Then, to prevent leakage, close the set screw (11),
Shut off the balloon system. The built-in valve and the valve (10) are not completely sealed, and are of a type that is discharged from the valve (10) through a reverse path when the set screw (11) is opened at the end of the treatment. is there.

A connector, which is merely a connecting member, may be attached to the end of the connecting pipe (8), and a mechanical or manual air supply / exhaust device may be connected as necessary. In this case, it is preferable to provide a means that can be optionally closed and opened by attaching a commercially available two-way stopcock or the like.

Next, the cushion members (13, 14) are elastic members having relatively large flexibility, and generally have a thickness of 10 mm.
The foamed sheet is processed and bonded or welded. As the material, for example, a synthetic resin such as a polyurethane resin or a polyethylene resin, or a foam sheet of a rubber such as natural rubber, isoprene rubber, neoprene rubber, or silicone rubber is used. As shown in FIG. 2, the position where the fixing plate is in contact with the skin is attached in the form of a stripe or over the entire surface, and at least the upper arm, the fixing part (2) of the forearm, and the hemostatic part (1). ) Are required at four locations on both sides of the balloon (12). In addition, it is preferable to select the elasticity and thickness of the material so that the fixing plate and the bands (4, 5) float on both sides of the fixing plate without coming into contact with the skin.

The bands (4, 5) are used to attach and fix a hemostatic device. Both ends of the fixing plate are fixed to the upper arm and the forearm with the two bands (4), and the elbow joint is pressed by the band (5). However, as a material thereof, for example, a cloth processed product such as cotton, hemp, chemical fiber, or the like, or a synthetic resin molded product of a urethane resin or a soft vinyl chloride resin is processed into a belt shape. One end is fixed to the hemostatic portion (1) of the fixing plate and the fixing portions (2) on both sides, but a device that can easily adjust the tightening diameter according to individual differences of patients is required. For example, when a magic cloth (manufactured by Nippon Velcro Co., Ltd.) for crimping a loop-like raised cloth (A) and a key-like raised cloth (B) is used, a band (4) is manufactured using the cloth (A). When the cloth (B) is pasted as a band fixing part (6) on the back side of the fixing part (2), the band (4) is crimped to the band fixing part (6) while being wound around the arm of the patient. If this is the case, tightening suitable for the outer diameter of the arm of the patient can be easily obtained.

The band (5) is attached to a side end of the hemostatic portion (1) while being wound around an elbow in order to ensure transparency of the hemostatic portion (1) of the fixing plate. )
It is preferable to adopt a method of inverting the band and turning it over with a magic cloth attached to the back surface of the band (5). Alternatively, a commercially available fixture made of metal or synthetic resin may be used. The band (5) has a width of about 30 to 150 mm, and the band (4) has a width of about 15 to 100 mm. However, the band (5) has a wide width in consideration of misalignment of the mounting operation in order to securely wrap the outer surface of the elbow. Is more preferred. In general, the maximum winding diameter of the band (4) is φ150 mm for the upper arm and φ
100 mm, φ140 mm for band (5), fits most patients.

[0021]

According to the wearable hemostatic device of the present invention, when the device is worn on the upper limb, the fixing plate is positioned so as to contact the upper arm, the elbow joint, and the forearm, and the fixing portions (2) at both ends are the upper arm and the forearm. Is securely fastened with a band (4). When the patient tries to bend the elbow joint, it is supported by the arm (3) of the rigid fixing plate, and the fixing points cannot be brought close to each other. Furthermore, when the band (5) for tightening and fixing the hemostatic part (1) located on the front elbow service is bent when the elbow joint is bent,
The outer surface of the elbow which is going to be separated from the hemostatic portion (1) is firmly held on the hemostatic portion (1) of the fixing plate. Therefore, by wearing the wearable hemostat of the present invention, the state of the wearer with the upper limb extended can be reliably fixed.

In addition, since there is a relatively soft cushion (13, 14) between the skin and the fixing plate, the cushion protects the skin and relieves excessive pressure on the peripheral blood vessels, and at least presses both sides thereof. Since no floating condition is formed, the peripheral hemodynamics can be maintained. Further, the balloon (12) serving as a pressurizer can be easily adjusted in pressure by supplying and discharging the gas or liquid from the rubber ball (9), and can be moved from a fixed plate fixed to the upper limb to a bleeding site. Because it swells, it can be reliably pressed to a limited area,
There is no danger that the position will shift during use. In addition, since the fixed plate hemostatic portion (1) and the balloon (12) are made of a transparent material, abnormalities such as rebleeding from the compressed hemostatic site during wearing can be easily visually recognized.

[0023]

[Effects of the Invention] As described above, the use of the wearable hemostatic device of the present invention prevents the movement of the elbow joint and the accompanying shift of the hemostatic device, thereby enabling safe and reliable pressing hemostasis limited to the bleeding site. In addition, the hemostasis time can be reduced in consideration of hemodynamics. In addition, since the pressure can be easily adjusted while observing the hemostatic site, effective hemostasis can be achieved by appropriate treatment. Furthermore, the lightweight and simple structure can be worn on the body, so that the patient can be treated. It is a wearable hemostatic device that can reduce the internal restraint and is useful for pressure hemostasis at the bleeding site of the upper limb from which a vascular catheter or the like has been removed.

[Brief description of the drawings]

FIG. 1 is an external view of a wearable hemostatic device according to an embodiment of the present invention.

FIG. 2 is a top view of a fixing plate.

FIG. 3 is a cross-sectional view taken along line AA ′ of the center of the fixing plate in FIG. 2;

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Hemostasis 2 Fixing part 3 Arm 4 and 5 Band 6 Band fixing part 7 Metal fitting 8 Connecting tube 9 Rubber ball 10 Valve 11 Set screw 12 Balloon 13, 14 Cushion 20 Fixing plate

Claims (2)

(57) [Scope of request for utility model registration] An inflatable and deflated balloon is provided on the surface of a central portion, and a hemostatic portion having cushioning materials disposed on both surfaces thereof is connected to and integrated with both sides of the hemostatic portion via arms. A fixing plate composed of two fixing portions provided with cushioning members, a supply / exhaust member having a distal end of a connecting pipe opened in the balloon, and a fixing band attached to the hemostatic portion and the two fixing portions. A wearable hemostatic device characterized by being constituted. 2. The fixing plate is made of transparent plastic,
The wearable hemostatic device according to claim 1, wherein the balloon is made of a transparent elastic material so that the hemostatic affected part can be seen through.