JP2713116B2 - Pressing 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 pressure hemostasis device for safely performing hemostasis after removing an insertion catheter used for medical diagnosis without disturbing a doctor's hand. .

[0002]

2. Description of the Related Art In order to diagnose the heart and blood vessels, it is often practiced in ordinary medical diagnosis to inject a contrast agent and perform X-ray imaging. At this time, in order to stop bleeding from the blood vessel puncture site, a doctor confirms the bleeding while pressing the site by hand for 30 to 60 minutes, and sometimes more. Further, in a patient who has a tendency to bleed, it may be necessary to continue the pressing after stopping the blood once, and there is a drawback that the physical and time burden on the doctor during this period is extremely large. Proposals have already been made to solve this problem, but none have yet become widespread. For example, (a) a compression method using a hard object, (b) a compression method using a single bag, and the like have been proposed. However, in (a), since the target tissue does not have a flat structure, the pressure is unevenly applied, and a large amount of pressure acts on other tissues (bones, etc.) before sufficient pressure is applied to the blood vessel. Because it is painful and cannot measure the pressure applied to the blood vessels, it is not possible to know whether or not the pressurization is appropriate. Is generated). In the above (b), a hint is given to an air bag called a manchette of a blood pressure measuring device that is widely used at present, but air is sent into a soft bag,
The puncture portion is pressed by the expanding force, and the pressure applied to the blood vessel can be grasped to some extent. However, this method has the following disadvantages. Sometimes the pressure applied to an artery cannot be accurately determined. Generally, when the bag is inflated, the surface of the bag into which a fluid (gas) having a capacity greater than the bag's specific volume is fed becomes tight, and the internal pressure becomes higher than the external pressure. Therefore, in this method of squeezing a blood vessel by inflation of the bag, the bag is over-inflated before sufficient effective pressure on the blood vessel is achieved, and the internal pressure of the bag increases from the middle regardless of the surrounding pressure. Such a situation easily occurs. In the case of obese patients, even though the pressure in the bag has reached a sufficient level, the pressure is not transmitted to the blood vessels. In the above-described bag compression method, the operation of gradually reducing the pressure still remains, and the doctor and nurse cannot leave the site, and the aimed labor saving is not so achieved. Since there is no problem in the effectiveness and safety of hemostasis with human power (by hand), if labor saving is not sufficiently achieved, there is no need for such a device, and the existence value is significantly reduced. There is a danger of prolonged compression causing damage to peripheral tissues and inducing intravascular thrombus. The decompression of the bag must be performed frequently by a doctor or nurse while measuring the time, and therefore, it is easy to cause mistakes such as forgetting or delaying the work. As a result, cases in which compression is unnecessarily performed for a long time frequently occur, and there is a risk that peripheral blood ischemia and intravascular thrombus formation may occur. In addition, since such a hemostatic device is contaminated by blood, it is necessary to use a disposable type in which the device is discarded after being used once without being reused. Therefore, it is necessary to manufacture without using expensive materials and equipment.

[0003]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a disposable type hemostatic device which performs a conventional hemostatic method with the device, and which can finely adjust a hemostatic pressing performed by a doctor or the like. Is what you do. Normally, in a pressurized hemostatic device that controls hemostasis while observing the bleeding state of the wound using a pressurized bag that is inflated by pressurized air, bleeding is initially stopped by pressure equal to or higher than blood pressure, and blood coagulation at the hemostatic site Even if the hemostatic pressure is reduced, hemostasis is maintained. In such a case, it is desirable to reduce the hemostatic pressure as much as possible. The hemostatic pressure required to maintain the blood flow necessary to maintain the normal state of the living tissue in the hemostatic portion depends on the size of the hemostatic portion, but if the pressing is performed while maintaining the normal (about 40 to 80 mmHg), the biological tissue The present inventors have found that it is possible to stop bleeding while flowing blood. Therefore, in accordance with the recovery of the autonomous hemostatic ability of the affected part of the hemostasis, the present invention is to reduce the hemostatic pressure to about 40 to 80 mmHg as soon as possible.
It is an object of the present invention to provide a press hemostatic device that accurately and stably maintains a hemostatic pressure at a pressure that does not damage a living tissue at about 40 to 80 mmHg as soon as hemostasis of an affected area is achieved, as much as possible without applying manual labor. It is.

[0004]

That is, the present invention comprises a pressurizing bag and pressurizing means, pressurizing release means and residual pressure controlling means communicating therewith, wherein the pressurizing bag has a fluid sealed therein. Consisting of a pressure sensing bag made of non-stretchable material and a compression bag made of non-stretchable material, wherein the pressurizing means presses a blood vessel by sending fluid into the non-stretchable material compression bag, The disposable type pressurized hemostatic device, characterized in that the pressure control means continuously reduces the pressure from a maximum hemostatic pressure to a desired residual pressure by a pressure adjusting valve or a pressure adjusting bag. It is. The press hemostatic device of the present invention,
This is a device in which a pressure bag, preferably a pressure bag made of a transparent plastic material, is fixed to an affected area to be stopped, air is pressurized into the affected area to inflate the affected area, and the affected area is stopped by pressing. The pressurized bag used in the present invention is connected to a pressure generating source by a vent pipe, and the vent pipe is connected to a pressure release means and a residual pressure control means. Further, a known jig such as a pressure gauge, a cock, a check valve, or a connector can be attached to the ventilation pipe, if desired, so that the hemostatic operation can be easily performed. One of the features of the present invention, the residual pressure adjusting means, by means of a pressure adjusting bag or a pressure adjusting valve, presses the hemostasis at an appropriate speed to follow an appropriate pressure required for hemostasis predicted based on clinical diagnostic findings. The pressure of the pressurized bag is controlled in conjunction with a pressure regulating bag or a pressure regulating valve so as to continuously lower the pressure and continuously reach a predetermined final residual pressure in which the blood flow required for the living tissue flows. By controlling the process of decreasing the pressure, the pressure required for hemostasis is maintained until the hemostatic ability of the living tissue itself is restored, without causing damage to the living tissue due to excessive pressure applied to the hemostasis. Can be completely controlled. As a pressurized bag, a non-stretchable material compression bag is laminated on a non-stretchable material pressure sensing bag filled with fluid, and a blood vessel is compressed by sending a fluid into the compression bag. Can be used.

[0005] The pressure sensing bag and the compression bag may be bonded and integrated, or may be individually configured, and can be used properly depending on the application. Since the pressure sensing bag is made of a non-stretchable material filled with a volume of fluid that does not exceed its volume, the pressure inside it is equal to the pressure pressed by the bag, and the pressure transmitted to the blood vessel is accurately monitored. can do. In addition, by using the pressure sensing bag and the compression bag separately, the pressure applied to the blood vessel can be accurately grasped by the pressure sensing bag, thereby improving safety and convenience. Furthermore, since only the pressure sensing bag directly touches the affected area,
It is sufficient to dispose only this, and the running cost can be reduced. By automatically reducing the pressure, labor saving is achieved, and the danger that the blood ischemia time is unnecessarily long due to delay or forgetting of the decompression work is avoided. Further, by pressing the pressure sensing bag in advance, it is possible to set so that a certain degree of pressurization remains in the affected part even after all the air in the compression bag is exhausted.
The pressurized bag used in the present invention is a hollow bag made of a plastic body, for example, polyethylene or polyvinyl chloride, for about 5 hours.
The one whose peripheral part is sealed so as to withstand a pressure of up to 00 mmHg can be used. Particularly, a transparent bag is preferable since the affected part can be observed. The same material can be used for the residual pressure adjusting bag used in the present invention. The pressurizing means used in the present invention is not particularly limited as long as it applies air pressure to the pressurizing bag, and any type can be used. It is preferable to pressurize by hand pressure or the like with a pump or the like in terms of ease of handling.

As the pressure releasing means used in the present invention, a known jig can be used without any particular limitation. For example, a cock, a pinch cock, a valve and the like can be used. The press hemostatic device according to the present invention can apply a normal biological blood pressure value (for example, 1) under a condition where the state of bleeding and hemostasis is preferably visible without damaging the living tissue around the puncture part.
20 ± 20 mmHg) or more, and then, according to the degree of recovery of the ability of the living body itself to stop and bleed due to blood coagulation in the puncture hole, to a set value (for example, 50 mmHg) considered to be desirable based on clinical data for a predetermined time. Automatically and continuously, and if necessary, maintain a predetermined pressure value. As a result, it is possible to minimize damage to living tissue due to stoppage or restriction of blood circulation due to excessive hemostatic pressure.
In the present invention, this pressing control is performed by the residual pressure control means.
The residual pressure control means used in the present invention is means for gradually decreasing the pressure of the pressurized bag to a constant low pressure, for example, continuously for 20 to 60 minutes. Or a method in which a pressurized bag is connected to a residual pressure adjusting bag with a vent pipe, and an orifice, a fine adjustment cock, and the like are provided in an intermediate passage therebetween. When a pressure regulating valve is used as the residual pressure regulating means used in the present invention, it is possible to simply open a cock that communicates with the pressure regulating valve whose release pressure is set to a predetermined pressure. As the pressure adjusting valve, a gas leaks at a set constant pressure, and a known pressure adjusting valve can be used without limitation as long as the inside of the system can be maintained at the set pressure. It is preferable that the air leaks slightly when the pressure of the valve sealed with a pressure equal to or higher than the rubber elastic force is applied.

As the residual pressure adjusting means used in the present invention,
When using a pressure adjustment bag, it can be performed by opening a ventilation pipe between the pressurization bag and the residual pressure adjustment bag. In this case, a method in which a fine adjustment cock and an orifice having an appropriate diameter are provided in parallel in an intermediate passage with the residual pressure adjustment bag is preferable because the rate of pressure decrease can be continuously and precisely controlled. In this method, when the pressure reduction speed is increased, the fine adjustment cock is used. When a gentle pressure reduction speed is required, the fine adjustment cock is closed to reduce the pressure by the orifice. In this case, by installing two or more orifices having different diameters in parallel as the orifice passage, the speed until reaching the final residual pressure can be variously adjusted. For example, when two types of orifices are used, one of them can be opened, two can be opened, and three types of reduction speed can be selected. If the number is three or more, more reduction rates can be selected. If a fine adjustment needle valve that can adjust the flow rate more accurately than the fine adjustment cock is used instead of the method using the orifice, the rate of decrease in pressing can be easily adjusted. The final residual pressure of the press hemostasis device of the present invention can be set to the minimum press required for hemostasis, which is deemed necessary by a doctor. The minimum residual pressure can be controlled by adjusting the release pressure of the pressure regulating valve and adjusting the initial pressure or the initial air volume of the pressure regulating bag.

[0008]

EXAMPLES Hereinafter, the present invention will be described in more detail by way of examples, but the present invention is not limited to the description of the examples. Embodiment 1 An embodiment of the present invention will be described below. The press hemostatic device shown in FIG. 1 is made of polyethylene film (thickness: 200 μm, press area: 130 mm × 130 mm, seal width: 5 mm).
A transparent polyethylene band 7 (thickness: 100 to 200 μm, width: 100 to 1) attached to a transparent pressure bag 1 of 00 mmHg.
The pressure bag 1 is fixed by wrapping the band 7 around the thigh or arm of the person to be measured (30 mm, length: 400 mm).
The strippable adhesive layer 11 having a width of 10 mm or 20 mm is provided at an appropriate interval in the length direction of the band 7, so that the fixation to the human body can be more reliably performed. The pressurized bag 1 includes a vent pipe 12
Thus, it is connected to the fine adjustment cock 2, the pressure gauge 3, the pressure adjustment valve 4, the connector 5 and the rubber ball 6 for pressurization. The pressurized bag 1 and the ventilation pipe 12 are appropriately held by a clamp or the like. The fine adjustment cock 2 is released when the pressure is released from the pressurized bag 1, and adjusts the amount of air passing through the pressure adjustment valve 4. The pressure can be monitored by the pressure gauge 3, and a safety valve is built in. The pressure regulating valve 4 attached to the ventilation pipe in FIG. 1 controls the residual pressure.
When it exceeds 0 mmHg, it functions as an open system, and when it reaches 50 mmHg, it closes and closes the pipeline system. The rubber ball pump 6 generates air pressure in the form of a pump by being pressed by hand pressure. The rubber ball pump 6 is connected to the pipeline system via the connector 5 and is provided with a pressure required for pressing the pressure bag. Is
Remove from connector 5. First, the pressurized hemostatic device of FIG. 1 first installs the pressurized bag 1 into which air has been press-fitted quickly on the affected part where hemostasis has been performed by a doctor's hand, winds the band around the band 7 and strongly fixes the bag. Pull out the hand of the doctor who stopped bleeding. At this time, since the pressure bag 1 and the band 7 are transparent, the state of hemostasis of the affected part can be well observed. When the pressure when the coil is firmly wound is insufficient for hemostasis, air is pressed into the pressurized bag 1 by the rubber ball pump 6,
Pressing is increased to a predetermined pressure required for hemostasis. In some cases, the physician can manually stop the bleeding until the stage of increasing the pressure. Next, the cock 2 is closed and the hemostasis is maintained by this pressing for a predetermined time. After the hemostasis is continued for a while by this pressing, the rubber ball pump 6 is removed. The fine control cock 2 is released to gradually release air from the pressure control valve 4 to gradually reduce the pressure of the pressurizing bag 1 to the pressure set by the pressure control valve.

Embodiment 2 FIG. 2 is a circuit diagram of another embodiment of the present invention, in which residual pressure adjustment is performed using a pressure adjustment bag 8. The same pressure gauges 31 and 32, fine adjustment cock 2, connectors 51 and 52, and rubber ball pumps 61 and 62 as those in the first embodiment can be used. Two vent pipes 12 and 13 emerge from the pressurized bag 1, and the vent pipe 12 at one outlet has a fine adjustment cock 2 and two orifices 10.
1 and 102 are connected in parallel, and a rubber ball pump 61 is connected to the other ventilation pipe 13 via a connector 51. Cocks 91 to 95 are provided at the positions of the ventilation pipes shown in the circuit diagram. When a plurality of orifices are arranged in parallel and cocks 93 and 94 are connected in series, three types of speeds at which the pressure of the pressure bag 1 is reduced to a predetermined residual pressure can be selected. The orifices 101 and 102 may be any of a capillary molded product, a filter membrane, and a rubber molded structure. The process is the same as that of the apparatus shown in FIG. The difference is that the pressure adjustment bag 8 is used instead of the pressure adjustment valve when releasing the pressure. Further, the use of the orifices 101 and 102 as the pressure releasing means allows the pressure drop to be adjusted precisely. Pressure adjustment bag 8
Is made of transparent vinyl chloride resin film and can withstand a pressure of up to 500 mmHg. A pressure gauge 31, a connector 51, and a rubber ball pump 61 are connected to the ventilation pipe 13 from the pressurized bag 1. Vent tube 1 from pressure adjustment bag
2, the pressure gauge 32, the connector 52, and the rubber ball pump 62 are connected. A cock 92 for an opening is provided in the residual pressure adjusting bag.

[0010] The pressure system of the apparatus having the above configuration is operated in the following procedure. First, a circuit is formed as shown in FIG. 2 with all the fine adjustment cocks and the cocks closed. The cock 91 in the ventilation tube 13 of the pressurized bag 1 is opened, and the rubber ball pump 61 is connected via the connector 51 to
Air is injected into the pressurized bag 1 to a pressure of 150 to 170 mmHg. The cock 91 of the ventilation pipe 13 is closed, and the pressing is performed to stop the bleeding for a certain time. Next, while observing the gauges 32 and 31, first open the cock of 93 or / and 94,
The pressure is continuously released to the residual pressure regulating bag by a predetermined orifice. At this time, a difference is observed between the pressures of the gauges 31 and 32. If the pressure of the gauge 32 and the pressure of the gauge 31 are close to each other, but the pressure has not yet decreased to the predetermined residual pressure, the cock 92 is opened, and the pressure of the residual pressure adjustment bag 8 is adjusted to a predetermined value while watching the gauge 32. Reduce to just below the residual pressure. By repeating this, the pressure of the pressure bag 1 can be reduced to a predetermined residual pressure. If the rate of decrease in pressure is too fast due to an erroneous operation or the like, and the hemostatic portion bleeds,
Increase pressure until bleeding stops. When it is determined that the pressing speed is too fast, the pressure of the residual pressure adjusting bag is increased by the rubber ball pump 62 while watching the gauge 32. Also, when temporarily reducing the pressure, the rubber ball pump 62 can be used, and the cocks 93 and 94 can be closed. As described above, in the second embodiment, it is possible to select various pressing reduction speeds and control the pressing by selecting the orifice, selecting the pressure of the residual pressure adjusting bag, selecting the opening / closing degree of the fine adjustment cock, and the like. FIG. 3 shows the pressure bag shown in FIG. 1 comprising a pressure sensing bag 21 and a compression bag 22. The pressure sensing bag is provided with a pressure gauge 3 and a pressure reducing valve for discharging a pressure fluid. The pressurizing bag is provided with a pressurizing rubber ball pump 6 through a vent pipe 12. A residual pressure control means (not shown) is connected to the connection pipe 14 in the compression bag. The pressure sensing bag and the compression bag are laminated by bonding or the like, but may be merely laminated. The pressure transmitted to the blood vessel is monitored by the pressure sensing bag, and the predetermined pressure required for hemostasis is sent to the compression bag by a rubber ball to measure the hemostasis of the affected area,
After hemostasis, the pressure is reduced by the residual pressure control means. The materials for the pressure sensing bag and the compression bag are as described above, for example, polyethylene film and polyvinyl chloride film. Of these, the pressure sensing bag can be removed and made disposable. The operation is performed in the same manner as in Example 1 or Example 2.

[0011]

According to the hemostatic device of the present invention, after diagnosis or medical treatment such as angiography, the pressure is controlled by using a disposable transparent resin pressure bag when bleeding caused by catheter puncture is stopped by pressing. Accordingly, in an environment in which the hemostatic state is visible, the pressure can be lowered while always maintaining the blood flow of the tissue in accordance with the degree of hemostasis, and the residual pressure can be continuously maintained until complete hemostasis. According to the press hemostasis device of the present invention, while significantly reducing the labor of the doctor for the conventionally required pressing, pressure reduction control can be performed based on the knowledge of clinical diagnosis, and after insertion of the catheter safely and securely for the living body. There is an advantage that hemostasis can be performed.

[Brief description of the drawings]

FIG. 1 is a schematic diagram showing a configuration of a press hemostasis device of the present invention.

FIG. 2 is a circuit diagram showing aspects and operations of another embodiment of the present invention.

FIG. 3 is a schematic diagram showing a configuration of another embodiment of a pressure bag.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Pressurization bag 2 Fine adjustment cock 3, 31, 32 Pressure gauge 4 Check valve 5, 51, 52 Connector 6, 61, 62 Rubber ball pump 7 Zone 8 Residual pressure adjustment bag 9, 91, 92, 93, 94, 95 cock 10, 101, 102 orifice 11 adhesive layer 12, 13 vent pipe 14 connecting pipe 15 pressure reducing valve 21 pressure sensing bag 22 compression bag

Claims (2)

(57) [Claims] 1. A pressure bag and pressurizing means for communicating thereto, have a pressure release means and a residual pressure control means, the pressure
The pressure bag is a pressure sensing bag made of a non-stretch material
And a compression bag made of non-stretch material.
Means for delivering fluid to the compression bag made of non-stretch material.
By compressing the blood vessel
Force control means, by a pressure regulating valve or pressure regulating bag,
The pressure is continuously reduced from the maximum hemostatic pressure to the desired residual pressure
It consists in, disposable blanking, characterized in that
Pressure type hemostatic device. 2. The pressure hemostatic device according to claim 1, wherein the pressure bag is made of a transparent plastic body.