WO2022195980A1

WO2022195980A1 - Hemostatic device

Info

Publication number: WO2022195980A1
Application number: PCT/JP2021/045050
Authority: WO
Inventors: 太輝人犬飼; 祐治鬼村
Original assignee: テルモ株式会社
Priority date: 2021-03-15
Filing date: 2021-12-08
Publication date: 2022-09-22
Also published as: JPWO2022195980A1

Abstract

Provided is a hemostatic device that can reliably detect the presence or absence of bleeding that has occurred during hemostasis. This hemostatic device 10 has: a pressing part 25 that presses a hemostasis site; a fixing part 20 that fixes the pressing part 25 to the hemostasis site; a first flow passage part 30 that is positioned at a peripheral section of the site where the pressing part 25 presses the hemostasis site, and opens toward the pressing direction of the pressing part 25; a reservoir part 32 that is positioned in a location removed from the site where the pressing part 25 presses the hemostasis site, and is in communication with the first flow passage part 30; and a detection part 42 that detects a color change in the reservoir part 32.

Description

hemostatic device

The present invention relates to a hemostatic device capable of stopping bleeding at a puncture site and detecting blood leakage.

For example, in cardiac catheterization and catheterization, an introducer sheath is introduced into the puncture site formed in the arm or leg, and a catheter or the like is inserted into a blood vessel or the like through the lumen of the introducer sheath for examination and treatment. etc. When such examinations and treatments are performed, it is necessary to stop bleeding at the puncture site after removing the introducer sheath. In order to stop bleeding, a hemostatic instrument is used that presses the site to stop bleeding.

In the radial artery, there is a possibility of occlusion complications due to compression, so when using a hemostatic device, it is required to stop bleeding while securing blood flow. For this reason, it is necessary to finely adjust the compression force while confirming the presence or absence of blood flow in the compressed area. If the pressure is weak and the hemostasis is insufficient, the bleeding may continue and the hemostasis time may be prolonged, or the blood may pool under the skin and cause a hematoma. I had to check regularly to make sure it wasn't there.

Patent Document 1 discloses a hemostatic device that determines the bleeding state based on an image of a hemostatic site captured by an imaging unit and adjusts the pressure that a pressing unit applies to the hemostatic site. This reduces the burden on medical staff.

JP 2020-163047 A

Bleeding that occurs when the hemostatic device starts to stop bleeding adheres to the area around the hemostatic site of the hemostatic device. For this reason, in many cases, some kind of bleeding is recognized in the image obtained by imaging the site of hemostasis. It is difficult to determine whether the bleeding seen in the image is due to insufficient compression.

The present invention was made to solve the above-described problems, and an object thereof is to provide a hemostatic device that can reliably detect the presence or absence of bleeding that occurs during hemostatic.

A hemostatic device according to the present invention that achieves the above objects comprises a pressing portion that presses a hemostatic site, a fixing portion that fixes the pressing portion to the hemostatic site, and a peripheral portion of the pressing portion that presses the hemostatic site. A first flow path portion that opens toward the pressing direction of the pressing portion, and a portion that is spaced apart from a portion of the pressing portion that presses the hemostasis site and communicates with the first flow path portion. It has a storage section and a detection section that detects a color change of the storage section.

The hemostatic device configured as described above allows blood to flow into the reservoir from the first flow path part away from the hemostatic site, and detects the presence or absence of bleeding. Bleeding can be detected with high accuracy without Moreover, since the presence or absence of blood is determined by the color change of the reservoir, erroneous detection of fluids other than blood can be prevented.

Fig. 2 is a plan view of the hemostatic device of the present embodiment as seen from the inner surface side; FIG. 4 is a cross-sectional view of the hemostatic device attached to the wrist; FIG. 4A is a plan view showing the positional relationship between the hemostatic site, the first channel portion, the second channel portion, and the reservoir, in which FIG. FIG. 10 is a diagram of a state in which the It is a partially enlarged view of the AA cross-sectional view of FIG. 3(a). It is a block diagram which shows the structure of a hemostatic device. FIG. 4 is a plan view of the hemostatic device viewed from the outside, in which (a) is a diagram with the opening/closing part closed, and (b) is a diagram with the opening/closing part open. FIG. 11 is a plan view showing the positional relationship among the hemostasis site, the first channel portion, the second channel portion, and the storage portion in a modified example in which the third channel portion is connected to the second channel portion; FIG. 11 is a plan view showing the positional relationship between the first channel portion, the hemostatic portion, the second channel portion, and the storage portion according to the modification;

Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for convenience of explanation and may differ from the actual ratios.

The hemostatic device 10 is used for the purpose of inserting a catheter or the like for examination, treatment, etc. into a blood vessel when and after removing an introducer sheath indwelling at a puncture site (hemostatic site S). Used to stop bleeding. In the following description, as an example, the hemostasis site S is the site where the sheath of the radial artery of the wrist has been introduced.

As shown in FIG. 1, the hemostatic device 10 includes a pressing portion 25 that presses the hemostatic site S, a fixing portion 20 wrapped around the wrist so as to fix the pressing portion 25 to the hemostatic site S, and an internal pressure of the pressing portion 25. and a pressure adjustment unit 27 that increases or decreases the pressing force on the hemostasis site S by adjusting .

The pressing part 25 is a flexible bag-like member that expands by injecting a fluid (gas or liquid such as air) to press and compress the hemostatic site S. In this embodiment, as an example, the fluid is air. Further, the pressing portion 25 may be a flexible sheet-like member that does not expand.

The pressure adjusting section 27 is connected to the pressing section 25 via a connecting tube 28 and can adjust the internal pressure of the pressing section 25 . The pressure adjustment unit 27 has a pressure pump 50 and a pressure adjustment valve 51 inside. The pressure pump 50 can increase the internal pressure of the pressing portion 25 to expand the pressing portion 25 . In addition, the internal pressure of the pressing portion 25 can be reduced by the pressure regulating valve 51 to contract the pressing portion 25 .

The fixing part 20 has a flexible band 21 and hook-and-loop fasteners 22 provided at both ends of the band 21 . As shown in FIG. 2 , the band 21 is wrapped around the wrist P, and both ends of the band 21 are fixed with hook-and-loop fasteners 22 .

The pressing part 25 presses the hemostasis site S at the site S'. A first flow path portion 30 is provided around the portion S'. The first channel portion 30 is formed so as to surround a portion S′ of the pressing portion 25 that presses the hemostasis portion S, and has a groove shape that opens toward the pressing direction of the pressing portion 25 . Therefore, when bleeding occurs from the hemostasis site S, the blood flows into the first channel portion 30 . The width of the first channel portion 30 is 0.1 to 4.0 mm.

As shown in FIG. 3( a ), the first channel portion 30 is connected to one end of a tubular second channel portion 31 . The other end of the second flow path portion 31 is connected to a storage portion 32 arranged at a position away from the portion S' of the pressing portion 25 that presses the hemostasis portion S. As shown in FIG. The second flow path portion 31 is formed to have an inner diameter of 0.1 to 4.0 mm. Note that the first channel portion 30 and the storage portion 32 may be indirectly communicated through the second channel portion 31 in this way, or the first channel portion 30 and the storage portion 32 may be connected. may be in direct communication with each other. The storage part 32 is hollow, and as shown in FIG. 3B, the blood that has flowed into the first flow path part 30 flows into the storage part 32 via the second flow path part 31 due to capillary action. can be done. The reservoir 32 has an air vent hole (not shown) so that blood can flow smoothly. The inner surface of the reservoir 32 may be made of a material that does not transmit light with a wavelength of 640 to 770 nm. As a result, regardless of the skin color of the patient, the background color during detection by the detection unit 42 can be made constant, and the detection accuracy of color change can be improved. As shown in FIG. 4 , the first flow path portion 30 is a groove having a V-shaped cross section formed on the surface of the pressing portion 25 . The first flow path portion 30 may have a shape other than the V-shaped cross section, and may have, for example, a U-shaped cross section or a rectangular cross-section. When the first channel portion 30 has a U-shaped cross section or a rectangular cross section, the edges on both sides are substantially perpendicular to the contact surface with the skin. can be suppressed. Further, when the first flow path portion 30 has a rectangular cross-section, processing is facilitated.

As shown in FIG. 2, a detection unit 40 is provided on the outer surface side of the reservoir 32 . As shown in FIG. 5, the detection unit 40 includes a control section 41 that controls the pressurizing pump 50 and the pressure adjustment valve 51 of the pressure adjustment section 27, and a detection section 42 that detects a change in color of the storage section 32. , and a notification unit 46 that can notify that bleeding has occurred. The detection unit 42 and the notification unit 46 are connected to the control unit 41 . A pressure sensor 44 is also connected to the controller 41 . The pressure sensor 44 is provided in the air flow path from the pressure adjusting portion 27 to the pressing portion 25 or on the inner surface of the pressing portion 25 to detect pressure changes in the pressing portion 25 . As a result, it is possible to detect the fluctuation of the internal pressure of the pressing portion 25 caused by the pulsation of the blood vessel and to detect the presence or absence of occlusion of the blood vessel.

The detection section 42 is a sensor that can detect a change in color when blood flows into the storage section 32 . Specifically, it is possible to use an imaging element that detects only light of red wavelength (640 to 770 nm) of blood. A proximity sensor that detects proximity of an object may be used as the detection unit 42 .

The notification unit 46 may be any one that can notify the user that bleeding has occurred by sound or light. Further, a display unit such as a liquid crystal screen that can display information such as the pressurized state in the detection unit 40 may be used. The notification unit 46 may transmit information to the effect that bleeding has occurred to the external device.

As shown in FIG. 6( a ), an opening/closing part 33 made of a transparent film is provided on the outer surface side of the storage part 32 . Since opening/closing portion 33 is transparent, detection portion 42 can detect the presence or absence of blood in storing portion 32 . One side of the opening/closing portion 33 is fixed to the band 21 . As shown in FIG. 6(b), the inside of the storage section 32 can be exposed by turning over the opening/closing section 33. As shown in FIG. Thereby, the blood that has flowed into the reservoir 32 can be wiped off.

Next, how to use the hemostatic device 10 will be described. On the wrist, the puncture site for the artery is usually located on the inner side of the wrist, biased towards the thumb side. While pressing the puncture site with a finger or the like, the band 21 is wrapped around the wrist so that the puncture site is positioned at the center of the first flow path part 30, and both ends of the band 21 are fixed with hook-and-loop fasteners 22. do.

When the hemostatic device 10 is attached to the wrist, the control section 41 causes the pressure pump 50 to increase the internal pressure of the pressing section 25 . At this time, the control unit 41 detects blood vessel pulsation with the pressure sensor 44 . When the pulsation of the blood vessel changes from being detected to not being detected, it is assumed that the blood vessel is blocked. 51 reduces the internal pressure of the pressing portion 25 .

After increasing the internal pressure of the pressing section 25 to a certain level, the control section 41 causes the pressure regulating valve 51 to gradually reduce the internal pressure over time. Further, when the detection unit 42 detects that blood has flowed into the storage unit 32, the control unit 41 assumes that bleeding has occurred at the hemostatic site S, and causes the notification unit 46 to notify that effect. The internal pressure of the pressing portion 25 is increased by the pressure pump 50 . At this time, the control unit 41 increases the internal pressure of the pressing unit 25 to the value at the beginning of hemostasis. Alternatively, the control section 41 may increase the internal pressure of the pressing section 25 by a constant value, or may increase the internal pressure of the pressing section 25 to an upper limit at which pulsation is detected by the pressure sensor 44 .

When bleeding occurs at the hemostasis site S, the user opens the opening/closing part 33 of the reservoir 32 and wipes off the blood in the reservoir 32 . As a result, when bleeding occurs again, it can be detected by the detection unit 42 .

The first flow path part 30 is separated from the hemostatic site S by a certain distance. Since blood flows in through the hemorrhage, even if blood adheres to the periphery of the hemostatic site S at the start of hemostasis, the possibility of erroneous determination of bleeding can be reduced. Also, in the case of a very small amount of bleeding, it is highly possible that the blood clots as it is over time, so it is possible not to judge this as bleeding.

Bleeding is determined by detecting a color change in the reservoir 32, so even if a liquid other than blood, such as sweat or water from washing hands, flows into the reservoir 32, it will not be determined as bleeding. Therefore, the presence or absence of bleeding can be accurately determined.

The first flow path part 30 and the second flow path part 31 may be coated in advance with a drug that prevents blood from coagulating. Agents that prevent blood coagulation include, for example, heparin and alkoxyalkyl (meth)acrylates. As a result, it is possible to prevent the blood from coagulating in the middle of the first channel portion 30 and the second channel portion 31 and preventing the blood from flowing into the storing portion 32 .

Further, as shown in FIG. 7, a third channel portion 35 communicating with a port portion 36 to which an external device can be connected may be connected to the second channel portion 31 . A syringe for injecting a fluid containing a drug that dissolves clotted blood, for example, can be connected to the port portion 36 . The third channel portion 35 is formed to have a certain inner diameter or more so that the blood flowing through the second channel portion 31 toward the storing portion 32 does not flow due to capillary action. Further, the third flow path part 35 is connected to the second flow path part 31 so that the fluid can be injected from the second flow path part 31 toward the first flow path part 30 side. As a result, the fluid introduced from the port portion 36 can flow from the third channel portion 35 toward the second channel portion 31 and the first channel portion 30 to dissolve the coagulated blood.

Further, as shown in FIG. 8, the first flow path portion 38 may be formed in a groove shape extending radially outward from the vicinity of the hemostasis site S with the hemostasis site S as the center. A plurality of first flow path portions 38 are formed in the circumferential direction, and each communicates with the second flow path portion 31 . Alternatively, each first channel portion 38 may be directly connected to the storage portion 32 . By forming the first flow path part 38 in this way, blood is guided from the first flow path part 38 to the storage part 32 even if the bleeding is very small. Therefore, even if the bleeding is very small, the bleeding can be reliably detected when the pressing portion 25 is to be pressed.

As described above, the hemostatic device 10 according to the present embodiment includes the pressing portion 25 that presses the hemostatic site, the fixing portion 20 that fixes the pressing portion 25 to the hemostatic site, and the portion of the pressing portion 25 that presses the hemostatic site. The first flow path part 30 is arranged in the peripheral part and opens in the pressing direction of the pressing part 25, and the first flow path part 30 is arranged at a position apart from the part of the pressing part 25 that presses the hemostatic part. It has a communicating storage section 32 and a detection section 42 that detects color change of the storage section 32 . The hemostatic device 10 configured in this manner causes blood to flow into the reservoir 32 from the first flow path 30 away from the hemostatic site, and detects the presence or absence of bleeding. Bleeding can be detected with high accuracy without discrimination. Moreover, since the presence or absence of blood is determined based on the color change of the reservoir 32, erroneous detection of fluids other than blood can be prevented.

It has a pressure adjustment unit 27 that adjusts the internal pressure of the pressing unit 25 to increase or decrease the pressing force on the site of hemostasis. The internal pressure of the pressing portion 25 may be increased when the color change of the storing portion 32 is detected by the portion 42 . This eliminates the need for medical staff to check the presence or absence of bleeding and adjust the pressure as needed, thereby reducing the burden on medical staff.

It has a pressure sensor 44 that detects a pressure change in the pressing portion 25, and the pressure adjusting portion 27 detects the presence or absence of blood vessel pulsation by the pressure sensor 44, and based on the presence or absence of the detected blood vessel pulsation, the inside of the pressing portion 25 You may make it control the increase/decrease of a pressure. As a result, it is possible to press the hemostasis site with an appropriate pressure while ensuring blood flow.

The first flow path part 30 may be formed in a groove shape surrounding the hemostasis site. This ensures that blood from the site of hemostasis is captured.

The first flow path part 38 may be formed in a groove shape extending radially outward from the vicinity of the hemostasis site, centering on the hemostasis site. As a result, even if there is a very small amount of bleeding, the blood is guided from the first flow path portion 38 to the storing section 32, so that even a very small amount of bleeding can be reliably detected when pressing by the pressing portion 25 is desired.

A second flow channel portion 31 may be provided to allow communication between the first flow channel portion 30 and the storage portion 32 . As a result, the storing part 32 can be arranged at a position distant from the site of hemostasis, and erroneous detection of bleeding due to blood adhering to the site of hemostasis and its surroundings can be prevented.

The second channel portion 31 may be formed in a tubular shape that opens to the first channel portion 30 and the storage portion 32 respectively. As a result, the blood that has flowed into the first channel portion 30 can be reliably delivered to the reservoir by capillary action.

The second channel portion 31 may be connected to a third channel portion 35 communicating with a port portion 36 to which an external device can be connected. Thereby, the blood clotted in the second channel portion 31 and the first channel portion 30 can be dissolved and removed through the port portion 36 and the third channel portion 35 .

The storage section 32 may have an opening/closing section 33 and may be opened to the outside by opening the opening/closing section 33 . As a result, the inside of the reservoir 32 into which blood has flowed can be wiped off, and the presence or absence of bleeding can be monitored again.

A notification unit 46 that notifies when a color change of the storage unit 32 is detected by the detection unit 42 may be provided. This can inform the surroundings that bleeding has occurred.

It should be noted that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical concept of the present invention. The control unit 41 may control the internal pressure increase of the pressing unit 25 by the pressure pump 50 based on information from sources other than the pressure sensor 44 . For example, the detection unit 42 detects a color change due to blood flowing into the storage unit 32 as well as a change in the area where the color changes, and the control unit 41 detects a change in the color detected by the detection unit 42. The internal pressure of the pressing portion 25 may be increased until the area stops increasing. By detecting a change in the area over which blood spreads in the reservoir 32, it is possible to reliably detect whether or not the bleeding continues. Alternatively, the amount of blood bleeding from the hemostasis site S and the flow velocity of the blood may be measured and compared with preset values to change the amount of increase in the internal pressure of the pressing portion 25 .

If the pressing portion 25 is a flexible sheet-like member that does not expand, the pressurizing pump 50 and the pressure regulating valve 51 are unnecessary. In this case, the pressing portion 25 has the first flow path portion 30 on the surface of the sheet-like member.

This application is based on Japanese Patent Application No. 2021-41465 filed on March 15, 2021, and the disclosure contents thereof are incorporated by reference.

REFERENCE SIGNS LIST 10 hemostatic device 20 fixing part 21 band 22 hook-and-loop fastener 25 pressing part 27 pressure adjusting part 28 connecting tube 30 first channel part 31 second channel part 32 storage part 33 opening/closing part 35 third channel part 36 port part 40 Detection unit 41 control unit 42 detection unit 44 pressure sensor 46 notification unit 50 pressure pump 51 pressure adjustment valve

Claims

a pressing portion that presses the site of hemostasis;
a fixing part that fixes the pressing part to the hemostatic site;
a first flow path portion disposed around a portion of the pressing portion pressing the hemostasis site and opening in the pressing direction of the pressing portion;
a reservoir disposed at a position away from a portion of the pressing portion that presses the hemostasis site and communicating with the first flow path;
a detection unit that detects a color change of the storage unit;
A hemostatic device having a
a pressure adjusting unit that increases or decreases the pressure applied to the bleeding site by adjusting the internal pressure of the pressing unit;
2. The pressure adjusting unit reduces the internal pressure of the pressing unit over time, and increases the internal pressure of the pressing unit when the detecting unit detects a color change of the storage unit. A hemostatic device as described.
Having a pressure sensor that detects a pressure change in the pressing portion,
3. The hemostatic device according to claim 2, wherein the pressure adjusting section detects presence or absence of vascular pulsation by the pressure sensor, and controls increase or decrease of the internal pressure of the pressing section based on the detected presence or absence of vascular pulsation.
The hemostatic device according to any one of claims 1 to 3, wherein the first channel portion is formed in a groove shape surrounding the hemostatic site.
The hemostatic device according to any one of claims 1 to 3, wherein the first channel portion is formed in a groove shape extending radially outward from the vicinity of the hemostatic site to the hemostatic site.
The hemostatic device according to any one of claims 1 to 5, further comprising a second channel portion that communicates the first channel portion and the reservoir portion.
The hemostatic device according to claim 6, wherein the second flow path section is formed in a tubular shape opening to the first flow path section and the storage section, respectively.
The hemostatic device according to claim 6 or 7, wherein the second channel portion is connected to a third channel portion communicating with a port portion to which an external device can be connected.
The hemostatic device according to any one of claims 1 to 8, wherein the storage part has an opening/closing part, and is opened to the outside by opening the opening/closing part.
The hemostatic device according to any one of claims 1 to 9, further comprising a notification section that notifies when the detection section detects a color change of the storage section.