JP7090964B1 - Hemostasis device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a hemostatic device capable of pressing a puncture portion with a more appropriate pressure. SOLUTION: A blood stop device 1 sandwiches a compression module 5 having a pad 51 having a compression surface 512, a module connection portion 4 integrated with the compression module by connecting the compression module, and a module connection portion. A pair of belts 2 to be attached are provided, and the compression module includes a fixed compression module in which the position of the compression surface of the pad is fixed with respect to the module connection portion, and a pad with respect to the module connection portion with respect to the compression surface. It has an adjustment compression module, which moves in the direction of vertical pad movement. [Selection diagram] Fig. 1

Description

The present invention relates to a hemostatic device.

For example, in artificial dialysis, vascular access (hereinafter referred to as “VA”) is required to take blood out of the blood vessel and return it to the blood vessel via a dialysis circuit. VA includes an internal shunt using an autologous blood vessel (AVF: ArterioVenotus Fistila), an internal shunt using an artificial blood vessel (AVG: ArterioVenolis Graft), and arterial superficialization. In the blood return work at the end of dialysis, after removing the two dialysis indwelling needles on the A side and the V side from the VA, hemostasis treatment of the puncture portion is started. Among VA, in AVF, as a general rule, the patient will perform pressure hemostasis (hereinafter referred to as "self-hemostatic") with the arm opposite to the arm of AVF, and if it is easy to stop bleeding, a hemostasis belt etc. will be supplemented. Can be used.

In Patent Document 1, a hard case is attached to a predetermined position of a band made of non-stretchable or low-stretchable fibers, a non-woven fabric, a film, or the like by any means, and the inside of the hard case is filled with a fluid to expand. In a compression hemostatic belt accommodating a possible balloon, a check valve is detachably attached to the balloon, the balloon, a fluid supply pipe for filling the balloon with fluid, and the fluid supply. The compression part is composed of a check valve that is detachably attached to the pipe, and the check valve is attached to the end of the fluid supply pipe by fitting or screwing in, and the check valve and fluid are attached. A sealing material such as packing is sandwiched between the supply pipe and the like.

Japanese Patent Application Laid-Open No. 7-040772

However, at present, manual compression hemostasis by medical staff is required for AVF, all AVG, arterial superficialization, and direct arterial puncture except when hemostasis is easy, and this hemostasis treatment requires at least. It takes about 10 minutes. Especially in a normal dialysis facility, the blood return work of patients is sequentially started with a short time difference, and as a result, the staff is in charge of multiple patients in parallel, and there is a concern that the efficiency of the blood return work is lost. ..
In the near future, dementia caused by the aging of dialysis patients, difficulty in self-hemostasis due to frail sarcopenia, etc., and increase in the transition to AVG due to the devastation and reconstruction difficulty of AVF due to the prolonged dialysis period. It is predicted that the number of AVF closures and switching to arterial superficialization will increase due to the decline in cardiac function, and there is a demand for hemostasis devices that can replace the current manual hemostasis.

The present disclosure has been made in view of the above circumstances, and an object of the present disclosure is to provide a hemostatic device capable of pressing a puncture site with a more appropriate pressure.

The hemostatic device of the present disclosure is a pair of a compression module having a pad having a compression surface, a module connection portion integrated with the compression module by connecting the compression module, and a pair attached by sandwiching the module connection portion. The compression module comprises a fixed compression module in which the position of the compression surface of the pad is fixed with respect to the module connection portion, and the pad is attached to the module connection portion with the compression surface. A hemostatic device with an adjustable compression module that moves the pad in the direction of movement perpendicular to the pad.

The hemostatic device of the present disclosure is a pair of a compression module having a pad having a compression surface, a module connection portion integrated with the compression module by connecting the compression module, and a pair attached by sandwiching the module connection portion. The compression module is a hemostatic device that is an adjustment compression module that moves the pad with respect to the module connection portion in a pad moving direction perpendicular to the compression surface.

Further, in the hemostatic device of the present disclosure, the direction in which the compression module is connected can be a direction perpendicular to both the pad moving direction and the extending direction of the pair of belts.

Further, in the hemostatic device of the present disclosure, the adjustment compression module may have a male screw for moving the pad in the pad moving direction. In this case, even if the adjustment compression module has a coil spring that supports the pad at one end and a spring pressing portion that contacts the other end of the coil spring and moves in the pad moving direction together with the male screw. good.

Further, in the hemostatic device of the present disclosure, the adjustment compression module may have a pinion for moving the pad in the pad moving direction. In this case, the adjustment compression module may have a coil spring that supports the pad at one end, and a spring pressing portion that contacts the other end of the coil spring and moves together with the pinion in the pad moving direction. ..

Further, in the hemostatic device of the present disclosure, the adjustment compression module may further include an electric motor for moving the spring pressing portion. In this case, even if the adjustment compression module further includes a vibration detection unit that converts vibration into an electric signal and a control unit that controls the electric motor in response to an input signal from the vibration detection unit. good. Further, in this case, the control unit determines whether or not the signal is within the predetermined range of the input signal, and if it is determined that the signal is not within the predetermined range, the operation unit moves the spring pressing unit with respect to the electric motor. May be instructed. The vibration detection unit may move within a range of 25 to 35 mm from the center of the compression surface.

Further, the hemostatic device of the present disclosure may further include a D ring attached to one of the pair of belts. Further, in the hemostatic device of the present disclosure, the pair of belts 2 may be made of nylon, and the module connection portion may be made of polycarbonate.

With the above configuration, the hemostatic device can be pressed against the puncture site with a more appropriate pressure.

It is a top view of the hemostatic device of this invention. It is a side view when the hemostatic device of FIG. 1 is made into an annular shape. It is a perspective view showing the vicinity of the compression module of the hemostatic device to which the fixed compression module is connected. It is a side view of a fixed compression module. It is a bottom view of a fixed compression module. It is a side sectional view showing the vicinity of the compression module of the hemostatic device to which the adjustment compression module is connected. It is a perspective view showing the vicinity of the compression module of the hemostatic device to which the adjustment compression module is connected. It is a figure which shows the state which the hemostatic device to which the adjustment compression module was connected attached to the arm. It is a figure which shows the 1st modification of the adjustment compression module, and is the sectional view around the compression module. It is a figure which shows the 2nd modification of the adjustment compression module, and is the partial sectional view around the compression module. It is a figure which shows the 3rd modification of the adjustment compression module, and is the perspective view near the compression module. It is a figure which shows the 4th modification of the adjustment compression module, and is the figure which shows the appearance of the hemostatic device to which the adjustment compression module having a microphone is attached attached to the arm. It is a block diagram which shows the control composition of the adjustment compression module in 4th modification. It is a flowchart which shows the example of the processing by a control unit.

Hereinafter, the configuration and function of the hemostatic device of the present disclosure will be described with reference to the drawings. In the description, the same elements are designated by the same reference numerals, and duplicate description will be omitted as appropriate.

FIG. 1 is a plan view of the hemostatic device 1 of the present invention. FIG. 2 is a side view when the hemostatic device 1 of FIG. 1 is fixed in an annular shape. FIG. 3 is a perspective view showing the vicinity of the compression module 5 of the hemostatic device 1 using the fixed compression module. FIG. 4 is a side view of the fixed compression module. FIG. 5 is a bottom view of the fixed compression module.
As shown in these figures, the hemostatic device 1 has a compression module 5, a module connection portion 4, and a pair of belts 2. Here, the hemostatic device 1 is attached to the D ring 3, which is a D-shaped ring attached to one end of the pair of belts 2, and the other of the pair of belts 2, and the other is bent through the D ring 3. It may have a hook-and-loop fastener 21 that can be overlapped and connected at the time.

The compression module 5 has a pad 51 with a compression surface 512 and a module body 52. The module body 52 can be made of a metal such as steel, and the pad 51 can be made of a material such as silicon rubber having elasticity and transparency. The module connection portion 4 is integrated with the compression module 5 by connecting the compression module 5. The pair of belts 2 are attached to the module connecting portion 4 with the module connecting portion 4 interposed therebetween.
The compression module 5 is a fixed compression module in which the position of the compression surface 512 of the pad 51 is fixed with respect to the module connection portion 4, and the pad 51 is moved with respect to the module connection portion 4 and the pad is moved perpendicular to the compression surface 512. It has two types, an adjustment compression module that moves in the direction (± Z direction), and each has a configuration that can be connected to the module connection portion 4. By having the different types of compression modules 5 in this way, the hemostatic device 1 can be used between different users and different user states. However, the hemostatic device 1 may be configured to have only the adjusting compression module, or may have a configuration having a plurality of types of adjusting compression modules instead of the fixed module.
Further, the pair of belts 2 may be made of a flexible member such as nylon or silicon, and the module connecting portion 4 may be made of a resin such as polycarbonate. As a result, the hemostatic device 1 from which the module connection portion 4 has been removed can be reused by performing autoclave sterilization or disinfection with hypochlorous acid.

As particularly shown in FIG. 3, a convex portion 521 is formed in the module main body 52, and a concave portion 41 is formed in the module connecting portion 4. The compression module 5 is fixed to the module connection portion 4 by inserting the convex portion 521 into the concave portion 41. The direction in which the compression module 5 is connected is ± X direction in which the pair of belts 2 extends, and ± Z direction in which the pad movement direction perpendicular to the compression surface 512 is ± Z direction. The direction. As a result, the compression module 5 is attached and detached in a direction different from the direction of pressure for hemostasis, so that the compression module 5 is securely fixed to the module connection portion 4 at the time of hemostasis.

FIG. 6 is a side sectional view of the vicinity of the compression module 5 of the hemostatic device 1 to which the adjustment compression module, which is one of the compression modules 5, is connected. FIG. 7 is a perspective view of the vicinity of the compression module 5 of the hemostatic device 1 to which the adjustment compression module is connected. As shown in these figures, the compression module 5 has a screw hole 522 in the module body 52, a male screw 532 having a screw thread 534 having one end connected to the pad 51 and screwing into the screw hole 522, and a male screw. It has a dial 531 connected to the other end of the 532. With such a configuration, by rotating the dial 531 the male screw 532 moves the pad 51 in the pad moving direction (± Z direction). Here, the dial 531 may be a screw head portion of the male screw 532.

FIG. 8 is a diagram showing a state in which the hemostatic device 1 to which the adjustment compression module is connected is attached to the arm A. The hemostatic device 1 has a configuration as shown in FIGS. 6 and 7, and even after the belt 2 is attached to the arm A by the hook-and-loop fastener 21, the male screw 532 is turned by using the dial 531. , The compression surface 512 can be moved in the direction of the arm A or in the direction away from the arm A, and the force for compressing the puncture portion can be adjusted. Further, for example, the dial 531 has a scale, and the user remembers the position where the belt 2 is fixed by the hook-and-loop fastener 21 and the scale of the dial 531 so that the puncture portion can be pressed with the same pressing force each time. can. Therefore, according to the hemostatic device 1 in the present disclosure, it is possible to press the puncture portion with a more appropriate pressure.

The adjustment compression module as shown in FIGS. 7 and 8 uses the screw mechanism itself as the pressing force adjusting means. Specifically, it is a pressing force generated from an axial movement toward the limb due to the rotation of the male screw 532. Since the skin at the hemostasis target site has elastic properties, it is not possible to apply a pressing force as accurately as the one using the coil spring 54 described later, but by measuring under the same conditions as the coil spring 54, it is a guideline to some extent. Can be attached.
The head of the male screw 532 is integrated with the dial 531 which is an adjustment dial, and the dial 531 has a scale. That is, the adjustment dial is located at the top of the module. Since the scale and the movement on the axis of the male screw 532 correspond to each other, it can be used as an approximate guide for the pressing force. Compared to the spring type, which will be described later, the structure is simpler and the cost can be reduced, so it is expected to be used when the compression force is not as precise as the spring type.
When the male screw 532 is rotated to move the male screw 532 on the axis line, the tip of the screw will naturally rotate, so if it is in direct contact with the pad 51, it will also rotate to the pad 51 due to friction between them. There is a risk that the hemostasis target site by the pad 51 will shift as the movement of the pad 51 tries to be transmitted. In order to prevent this, a cap may be attached to the tip of the screw. As a whole, it has a thin disk shape with one side open in the axial direction, and has a structure that covers the tip of the screw. As a result, the pad 51 does not rotate even if the tip of the screw rotates, and the above-mentioned inconvenience can be avoided.

FIG. 9 is a diagram showing a first modification of the adjustment compression module, and is a cross-sectional view of the vicinity of the compression module 5. As shown in this figure, in the first modification, the compression module 5 has a male screw 532 as in FIGS. 6 and 7, but further has a coil spring 54 that supports the pad 51 at one end and a coil spring. It has a spring pressing portion 533 that comes into contact with the other end of the 54 and moves in the direction of the compression surface 512. In the example of FIG. 9, the pad 51 is supported by a spring receiver 511 connected to the coil spring 54 by adhesion or the like. Here, the pad 51 and the spring receiver 511 may be integrated. In the present embodiment, the module main body 52 is provided with a hole portion 523 for arranging the coil spring 54. With such a configuration, as in FIGS. 6 and 7, the hemostatic device 1 adjusts the force for pressing the puncture portion even after the belt 2 is attached to the arm A by the hook-and-loop fastener 21. Can be done. Further, since the pressure on the puncture portion is buffered by the coil spring 54, the puncture portion can be pressed while maintaining the pressure within a predetermined range even when the arm A or the like vibrates or moves, and the puncture portion can be pressed. On the other hand, it can be pressed at an appropriate angle.

When the compression module 5 according to the first modification is used, the restoring force of the spring is generated by compressing the coil spring 54 from above toward the limb while the pad 51 is in close contact with the hemostasis target site. As a result, the pad 51 attached to the tip of the spring can press the hemostasis target site.
By using the coil spring 54, the pressing force generated from the restoring force of the spring can be calculated from Hooke's law. Specifically, it is possible to make precise adjustment with the optimum pressing pressure according to the blood pressure (mmHg) of the blood vessel to be stopped. As an example, in hemostasis for VA, the strength of the coil spring 54 is set in advance so that the restoring force generated when the coil spring 54 is compressed can be adjusted in the range of 6.7 to 33.3 kPa (50 mmHg to 250 mmHg). ing.
A screw mechanism is used as a pressing force adjusting means for compressing the coil spring 54. By performing the rotation operation of the male screw 532, the spring compression plate attached to the tip of the screw moves in the axial direction of the limb, and the compression ratio of the coil spring 54 is changed. The head of the male screw 532 is integrated with the adjustment dial, and the adjustment dial has a scale. That is, the adjustment dial is located at the top of the module. Since the scale and the movement of the screw on the axis correspond to each other, the compression ratio of the coil spring 54 can be adjusted by the scale. That is, the pressing force can be adjusted by the adjustment dial.

The core rod 58 extending from the spring receiver 511 is a cylindrical object located in the center of the coil spring 54 and extending from the pad 51 in the direction opposite to the limb, and has a role of preventing buckling of the coil spring 54 and a role of setting an upper limit of the pressing force. Also fulfills. That is, by adjusting the length of the core rod 58 of the pad 51, it is possible to set the limit at which the coil spring 54 is not further compressed. Therefore, the restoring force of the coil spring 54, that is, the upper limit of the pressing force is physically determined. Make it possible.
When the male screw 532 is rotated to move the male screw 532 on the axis line, the tip of the screw naturally rotates, so if it is in direct contact with the spring compression plate, the friction between them causes the spring compression plate to become. However, the movement of rotation becomes a resistance as it tries to be transmitted. In order to prevent this, a cap may be attached to the tip of the screw. The cap has a thin disk shape with one side open in the axial direction as a whole, and has a structure that covers the tip of the screw. As a result, the cap does not rotate even if the tip of the screw rotates.
A circular female screw penetrating in the thickness direction is formed on the upper surface of the spring frame. By taking a large rotation resistance when the male screw 532 is screwed here, it is possible to eliminate the need for means for preventing the reverse rotation of the male screw 532. If this is not the case, it is necessary to separately provide a ratchet claw mechanism as a rotation regulating means.

FIG. 10 is a diagram showing a second modification of the adjustment compression module, and is a partial cross-sectional view of the vicinity of the compression module 5. As shown in this figure, in the second modification, the compression module 5 has a coil spring 54 and a spring pressing portion 533 as in FIG. 9, but the rack 56 that moves the pad 51 in the pad moving direction. And have a pinion 57. More specifically, the rack 56 and the pinion 57 move the pad 51 via the coil spring 54 by moving the spring pressing portion 533 in the pad moving direction. With such a configuration, the central axis of the dial 531 can be provided in any direction in the XY plane of the module main body 52. Thereby, even when the dial 531 is turned, the force for pressing the puncture portion can be adjusted without applying the force for rotating the puncture surface. In the second modification, the rack 56 and the pinion 57 are used in the configuration having the coil spring 54, but the configuration shown in FIGS. 6 and 7, which does not have the coil spring 54, is replaced with the screw hole 522 and the male screw 532. The rack 56 and the pinion 57 may be used.

The second modification differs from the first modification in that a rack and a pinion mechanism are used as the pressing force adjusting means for compressing the coil spring 54. Specifically, the rack 56 is arranged on the axis of the module with respect to the limbs, and a spring compression plate is adhered to the lower end of the rack. Since the rack 56 moves on the axis due to the rotation of the pinion 57, the spring compression plate also moves on the axis, and as a result, the compression ratio of the coil spring 54 also changes.
Further, by connecting or integrating the pinion 57 and the adjustment dial with the scale, it is possible to make the scale of the adjustment dial correspond to the rotation ratio of the pinion 57, and the compression ratio of the coil spring 54 is also adjusted. That is, the pressing force can be adjusted by the adjustment dial.
Also in the second modification, the structure and position of the coil spring 54 are the same as those in the basic example, and only the structure above the spring compression plate is deformed. Since the pinion 57 is located vertically on the axis, the adjustment dial is located on the side surface of the module. As a result, the height of the entire module can be suppressed as compared with the basic example, and the affinity with the electric module described later in terms of mechanism can be enhanced.
A circular female screw penetrating in the thickness direction is formed on the side surface of the spring frame. By taking a large rotation resistance when the male screw 532 is screwed here, it is possible to eliminate the need for means for preventing the reverse rotation of the male screw 532. If this is not the case, it is necessary to separately provide a ratchet claw mechanism as a rotation regulating means.

FIG. 11 is a diagram showing a third modification of the adjustment compression module, and is a perspective view of the vicinity of the compression module 5. As shown in this figure, in the third modification, in addition to the configuration of any of the above-mentioned adjustment compression modules, an electric motor 61 for rotating the dial 531 to move the spring pressing portion 533 is further provided. There is. It also has a battery 62 that supplies electric power to drive the electric motor 61, and an operation panel 63 for instructing the operation of the electric motor 61. With such a configuration, the user can press the puncture portion with an appropriate force by a simpler operation of operating the operation panel 63.

FIG. 12 is a diagram showing a fourth modification of the adjustment compression module, and is a diagram showing a state in which a hemostatic device 1 to which an adjustment compression module having a microphone 7 is connected is attached to an arm A. FIG. 13 is a block diagram showing a control configuration of the adjustment compression module in the fourth modification. As shown in these figures, in the fourth modification, in addition to the configuration of the third modification described above, in response to an input signal from the microphone (vibration detection unit) 7 that converts vibration into an electric signal. It differs in that it further has a control unit 8 for controlling the electric motor 61. As shown in FIG. 13, the control unit 8 inputs signals from the microphone 7 and the operation panel 63, and outputs an instruction to control the operation of the electric motor 61. In the present embodiment, the microphone 7 that detects voice is used as the vibration detection unit, but a vibration detection unit that detects vibration other than voice may be used. Here, the control unit 8 is mainly composed of a semiconductor device, and is connected to a volatile storage unit such as a CPU (Central Processing Unit) and a RAM (Random Access Memory), a non-volatile storage unit such as a flash memory, and a communication network. It may be configured as an information processing device having a network interface unit or the like.

FIG. 14 is a flowchart showing an example of processing by the control unit 8. As shown in this figure, the control unit 8 first acquires the audio signal detected from the microphone 7 in step S11. Next, in step S12, it is determined whether or not the volume is within the predetermined range. When it is determined that the volume is lower than the predetermined range, the electric motor 61 is instructed to drive the compression surface 512 to be raised in the −Z direction, the compression is relaxed, and the process proceeds to step S15. On the other hand, if it is determined that the compression surface 512 is larger than the predetermined range, the electric motor 61 is instructed to drive the compression surface 512 to be lowered in the + Z direction, the compression is increased, and the process proceeds to step S15. If it is determined that the range is within the predetermined range, the process proceeds to step S15 as it is. In step S15, it is determined whether or not there is an end instruction from the operation panel 63, and if there is no end instruction, the process returns to step S11 and the process is repeated. On the other hand, when the end instruction is given, the electric motor 61 is instructed to drive the electric motor 61 to a predetermined position where the pressure is relieved in step S16, and the process is terminated.

As described above, when the vibration detection unit such as the microphone 7 is used, the force of pressing the puncture portion by the compression module can be adjusted while checking the so-called shunt sound. For example, when the shunt sound is small, it can be determined that the blood vessel is occluded because the pressing force is large. Further, when the shunt sound is loud, it can be determined that the pressing force is small and a large amount of blood flow is flowing. In this way, the control unit 8 determines whether or not the value of the input signal is within the predetermined range, and if it is determined that the value is not within the predetermined range, the operation unit 8 moves the spring pressing unit 533 and the pad 51 with respect to the electric motor 61. Therefore, the hemostatic device 1 can press the puncture portion more appropriately.
The vibration detection unit as the microphone 7 can be configured to move within a range of 25 to 35 mm from the center of the compression surface 512. With such a configuration, for example, the shunt sound can be detected at an appropriate position downstream of the hemostatic site in dialysis. Further, the operation panel 63 may have a sensitivity adjusting unit for adjusting the sensitivity of the vibration detection unit as the microphone 7.

As described above, according to the hemostatic device 1 according to the present embodiment, the puncture portion can be pressed with a more appropriate pressure.
It should be noted that the description of the above-described embodiment is an example, and the case where changes and modifications that can be conceived by those skilled in the art are included in the scope of the idea of the present invention also belongs to the scope of the present invention. For example, a configuration in which the constituent elements of the embodiment are changed to alternative configurations or the constituent elements are deleted is also within the scope of the present invention as long as it is within the scope of the idea of the present invention.

1 Blood stop device, 2 belt, 3D ring, 4 module connection part, 41 concave part, 5 compression module, 21 side fastener, 51 pad, 511 spring receiver, 512 compression surface, 52 module body, 521 convex part, 522 screw hole, 523 holes, 513 dials, 532 male screws, 533 spring presses, 534 threads, 54 coil springs, 56 racks, 57 pinions, 58 core rods, 61 electric motors, 62 batteries, 63 operation panels, 7 vibration detectors (microphones). ), 8 Control unit

Claims (7)

A module connection part that integrates an adjustable compression module with a pad with a compression surface and the adjustment compression module, and attaches a pair of belts across the adjustment compression module.
An electric motor that moves the pad with respect to the module connection portion in the pad moving direction perpendicular to the compression surface.
A vibration detector that converts vibration into an electrical signal,
A hemostatic device including a control unit that controls the electric motor in response to an input signal from the vibration detection unit. The control unit determines whether or not the input signal is within a predetermined range, and if it is determined that the input signal is not within the predetermined range, the control unit instructs the electric motor to move the pad. The listed hemostatic device. The hemostatic device according to claim 1 or 2, wherein the vibration detection unit is arranged within a distance of 25 to 35 mm from the center of the compression surface. The adjustment compression module is
A coil spring that supports the pad at one end and
The hemostatic device according to claim 1 or 2 , further comprising a spring pressing portion that comes into contact with the other end of the coil spring and moves in the pad moving direction. The hemostatic device according to claim 1 or 2 , wherein the adjustment compression module has a pinion that moves the pad in the pad moving direction. The adjustment compression module is
A coil spring that supports the pad at one end and
The hemostatic device according to claim 5, further comprising a spring pressing portion that comes into contact with the other end of the coil spring and moves together with the pinion in the pad moving direction. The hemostatic device according to claim 1 or 2 , wherein the direction in which the adjusting compression module is connected to the module connection portion is a direction perpendicular to both the pad moving direction and the direction in which the pair of belts extends.

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