CN108720885B

CN108720885B - Hemostatic device

Info

Publication number: CN108720885B
Application number: CN201710262671.9A
Authority: CN
Inventors: 杜翌群; 林美燕; 陈诗涵; 邱纬翔
Original assignee: Southern Taiwan University of Science and Technology
Current assignee: Southern Taiwan University of Science and Technology
Priority date: 2017-04-20
Filing date: 2017-04-20
Publication date: 2021-02-05
Anticipated expiration: 2037-04-20
Also published as: CN108720885A

Abstract

A hemostatic device, comprising: a main body, a main hemostatic member, at least one auxiliary hemostatic member, a flow sensor, a pressure sensor, a controller, for performing the following steps: A. applying a main geometric surface to a puncture point of a blood vessel for hemostasis pressure, and applying at least one auxiliary geometric surface to a position outside the puncture point for hemostasis pressure outside the puncture point, wherein the hemostasis pressure outside the puncture point directly or indirectly acts on the blood vessel. B. In the process of hemostasis, obtaining a hemostasis period flow rate of blood in the blood vessel, and simultaneously applying pressure through the hemostasis pressure of the puncture point and the hemostasis pressure outside the puncture point to enable the value of the hemostasis period flow rate to be lower than a normal flow rate value of the blood vessel, wherein the hemostasis pressure of the puncture point and the hemostasis pressure outside the puncture point are lower than a systolic pressure of the blood vessel.

Description

Hemostatic device

Technical Field

The present invention relates to a hemostatic device, and more particularly, to a hemostatic device that applies pressure simultaneously at multiple points using a small hemostatic pressure.

Background

In medical clinics, effective hemostasis is required for blood vessels after puncture or trauma, such as radial artery hemostasis after puncture or trauma coronary angioplasty, fistula hemostasis after hemodialysis treatment, and the like. Taking hemodialysis treatment as an example, the number of chronic renal failure patients in taiwan is increasing year by year, and the renal failure diseases are mainly caused by the fact that the kidney is out of function and metabolic wastes of human body cannot be discharged out of body through the kidney and accumulated in the body, so that the patients need to receive hemodialysis treatment regularly to maintain healthy life and lives. Hemodialysis treatment is mainly used to replace the kidney of a patient who has lost function, and remove excessive water, toxins and waste products from the blood of the patient by concentration diffusion (diffusion) and convection (convection) principles.

Before hemodialysis treatment, a patient must firstly receive arteriovenous fistula, a fistula is connected between an artery and a vein of an arm, and when a kidney is washed, a nursing staff can puncture a puncture needle on the fistula to drain the blood of the patient out, pass through a hemodialysis machine and return the washed blood to the body of the patient, so that the continuous circulation takes about 4-5 hours to complete hemodialysis. After the hemodialysis treatment is finished, a nursing staff must remove the puncture needle, and the puncture needle is quite thick, so the puncture point needs to be covered by cotton cloth and pressed by fingers immediately after the puncture needle is removed, the pressure and the pressurization time generally depend on the experience of the medical staff, and after the blood is stabilized, the tourniquet is used for replacing the pressed fingers to continuously pressurize and stanch the puncture point.

The traditional tourniquet used clinically is a bandage made of elastic fibers, when hemostasis is performed, the pressure of tightening can be easily generated due to unquantized winding, the situations of overlarge applied pressure or insufficient pressure and the like can occur, when the pressure applied by the tourniquet is overlarge, fistula can be narrowed and embolism can be caused, finally, the function is lost, and the tissue hypoxia can be caused due to insufficient blood supply of tail end microcirculation. In addition, when the pressure applied by the tourniquet is insufficient, the wound of the renal-washing fistula cannot stop bleeding, and the risk of blood loss is caused.

Therefore, the inventor proposes an improved design of tourniquet, for example, the new model of "tourniquet device" in taiwan published as 8/11/98 in taiwan, it comprises a bandage, a sensor and a warning device which are respectively fixed on the bandage, the bandage comprises a belt body and a hemostatic convex block fixed on the belt body, the sensor is arranged on the bandage and can sense the blood flow smoothness of a bleeding blood vessel and output a sensing signal, the warning device is connected with the sensor signal, and generates a message indicating the smoothness of the blood flow in the blood vessel corresponding to the sensing signal, the sensor fixed on the binding band can output the sensing signal corresponding to the smoothness of the blood flow, the warning device can automatically output the message indicating the smoothness of the blood flow corresponding to the blood flow, so that the renal irrigator can know the current fistula condition directly from the message output by the warning device, and a stethoscope does not need to be worn at any time to listen to the blood flow sound of the fistula when the fistula is pressed to stop bleeding. However, the tourniquet device is not ideal in use because the design of an automatic feedback pressure adjusting mechanism is lacked, and the condition of tissue hypoxia caused by insufficient blood supply of the end microcirculation is still easy to occur because the whole pressure of the tourniquet is excessively applied in use.

Also, as disclosed in patent No. I533835 of the invention, "intelligent pressure-adaptive tourniquet and hemostasis method", published in taiwan 5/21/105, the disclosed intelligent pressure-adaptive tourniquet includes a band, a controller disposed on an outer surface of the band, an air bag disposed inside the band, and a pressure plate disposed on an inner side of the band. The controller is internally provided with a pressurizing unit, a pressure relief valve, a pressure sensing unit and an IC control chip, wherein the pressurizing unit, the pressure relief valve and the pressure sensing unit are respectively communicated with the air bag body, and the IC control chip is respectively and electrically connected to the pressurizing unit, the pressure relief valve and the pressure sensing unit. The average arterial pressure of a region to be stanched is measured by the sensing unit, and then the IC control chip, the pressurizing unit and the pressure release valve are utilized to interact with the air bag body, so that the pressure plate has a hemostasis pressure to act on the region to be stanched. However, because the pressure plate is only used for applying pressure to a to-be-hemostatic area (i.e. a puncture bleeding hole) to stop bleeding, the descending amplitude of the blood flow rate is slow, and particularly for some patients with weak blood coagulation function, longer time for applying pressure to stop bleeding is needed, although the invention No. I533835 can provide set time for stopping bleeding, the setting of the time for stopping bleeding only depends on the experience of medical personnel, if the medical personnel do not pay attention to whether the blood coagulation function of the patient is weak, and only set the blood coagulation function by the experience, the situation that the time for stopping bleeding is reached and the situation that the patient still stops bleeding completely is found after the intelligent pressure-suitable tourniquet is detached is inevitable; on the contrary, in some patients who have a strong blood coagulation function due to taking a medicine, if the hemostatic time is set too long, the fistula is likely to fail.

Therefore, it is necessary to develop an effective hemostasis method to avoid using excessive and inappropriate hemostasis pressure, so as to reduce the discomfort of the patient during hemostasis. In addition, the use of a hemostasis pressure less than the vasoconstriction pressure can avoid over-compression of the fistula during hemostasis, thereby effectively prolonging the service life of the fistula.

Disclosure of Invention

In view of the above-mentioned disadvantages of the conventional single-point hemostasis method, the present invention provides a hemostasis device, comprising: a main body, a main hemostatic member, at least one auxiliary hemostatic member, a flow sensor, a pressure sensor, a controller, for performing the following steps: A. applying a main geometric surface to a puncture point hemostasis pressure on a puncture point of the blood vessel, and applying at least one auxiliary geometric surface to at least one puncture point external hemostasis pressure on a position outside the puncture point, wherein the puncture point external hemostasis pressure directly or indirectly acts on the blood vessel. B. In the process of hemostasis, obtaining a hemostasis period flow rate of blood in the blood vessel, and simultaneously applying pressure through the hemostasis pressure of the puncture point and the hemostasis pressure outside the puncture point to enable the value of the hemostasis period flow rate to be lower than a normal flow rate value of the blood vessel, wherein the hemostasis pressure of the puncture point and the hemostasis pressure outside the puncture point are lower than a systolic pressure of the blood vessel.

Step B above gives a flow rate value during hemostasis of less than 60% of the normal flow rate value.

The auxiliary geometric surface has more than one, the main geometric surface has a main geometric center, the auxiliary geometric surfaces each have an auxiliary geometric center, and the main geometric center and the auxiliary geometric centers are equidistant.

The auxiliary geometric surface has more than one, the main geometric surface has a main geometric center, the auxiliary geometric surfaces each have an auxiliary geometric center, and the main geometric center and the auxiliary geometric centers are not equidistant.

The distance between the main geometric center and the auxiliary geometric centers is between 0.5 cm and 3.5 cm.

The main geometric surface has a main geometric surface edge, the auxiliary geometric surfaces have auxiliary geometric surface edges respectively, and the shortest distance between the main geometric surface edge and the auxiliary geometric surface edges is greater than 0 cm and less than 3.5 cm.

The value of the hemostasis pressure outside the puncture point is the same as that of the hemostasis pressure of the puncture point.

In the step B, the flow rate during the hemostasis period is obtained for a plurality of times, and the hemostasis pressure of the puncture point or/and the hemostasis pressure outside the puncture point is correspondingly changed during the hemostasis process according to the value of the flow rate during the hemostasis period obtained each time.

The step B uses an optical measuring device or an ultrasonic measuring device to obtain the flow rate during hemostasis.

The hemostatic pressure is given to the puncture point and the hemostatic pressure outside the puncture point through manual operation of the pressurizing device.

The computer program controls the pressurizing device to provide the hemostasis pressure to the puncture point and the external hemostasis pressure to the puncture point.

The invention further comprises a step C of collecting messages, during the hemostasis period, a controller collects one or a combination of the following messages: the hemostasis pressure of the puncture point, the external hemostasis pressure of the puncture point, the flow rate during hemostasis, the contraction pressure, the hemostasis operation time, the working temperature of a main geometric surface and the working temperature of an auxiliary geometric surface.

The step C comprises a message output step, in which the collected result of the message collection step is transmitted by the controller.

The step C comprises a prompt step, comparing the collection result of the message collection step with a default value, and selectively outputting a prompt signal according to the comparison result.

According to the technical characteristics, the invention has the following advantages:

1. compared with the existing single-point hemostasis method, the invention can realize hemostasis by using a method of simultaneously applying pressure at multiple points only by using smaller hemostasis pressure, and the applied hemostasis pressure can be smaller than the systolic pressure of blood vessels, so that the discomfort during hemostasis can be greatly reduced.

2. The multi-point hemostasis method is suitable for radial artery hemostasis after coronary angioplasty, arteriovenous fistula hemostasis after renal lavage of renal patients, pressurization hemostasis during limb arteriovenous catheter removal and the like, and can respectively press a puncture point and a position near the puncture point to perform hemostasis through the main hemostasis piece and at least one auxiliary hemostasis piece so as to achieve a multi-point hemostasis method for applying pressure with smaller hemostasis pressure. Thus effectively protecting the fistula from being compressed excessively to narrow embolism, reducing the impact on the fistula and causing fistula complications, reducing the fistula reconstruction rate and ensuring the life safety of a patient.

Drawings

FIG. 1 is a flow chart of the method steps of the present invention.

Fig. 2 is a perspective view of the hemostatic device of the present invention.

FIG. 3 is a schematic view of the main hemostatic member and the two auxiliary hemostatic members of the present invention located in a same line and at equal distances.

FIG. 4 is a schematic view of the main hemostatic member and the two auxiliary hemostatic members of the present invention located on the same line and at different distances.

FIG. 5 is a block diagram of the configuration and control of the controller according to the present invention.

Fig. 6 is a schematic view of the present invention used for hemostasis.

FIG. 7 is a schematic view of the main hemostatic member and the two auxiliary hemostatic members of the present invention not being in the same line and being equidistant.

FIG. 8 is a schematic view of the primary hemostatic member and a secondary hemostatic member of the present invention positioned in a common line.

FIG. 9 is a schematic view of the main hemostatic member and an auxiliary hemostatic member of the present invention not being aligned.

FIG. 10 is a graph showing the pressure values and descending flow rate of the single-point pressing, two-point pressing and four-point pressing according to the present invention.

FIG. 11 is a simplified schematic diagram of a simulation system for performing a hemostasis pressurization experiment in accordance with the present invention.

Fig. 12 is a perspective view of a single point hemostatic member for use in the experiments of the present invention.

Fig. 13 is a perspective view of a two-point hemostatic member for use in the experiments of the present invention.

FIG. 14 is a perspective view of the four-point equidistant hemostatic member of the present invention.

Fig. 15 is a schematic view of a simulated single-point hemostatic device of the present invention applying hemostatic pressure to an artificial fistula.

Fig. 16 is a schematic view of a simulated two-point hemostatic device of the present invention applying hemostatic pressure to an artificial fistula.

Fig. 17 is a schematic view of hemostatic compression on an artificial fistula using a simulated four-point equidistant hemostatic device of the present invention.

Description of reference numerals: 1-body; 11-a belt; 12-hemostatic surface; 2-a primary hemostatic member; 21-a main geometric surface; 22-main geometric center; 23-main geometric face edge; 3-an auxiliary hemostatic member; 31-auxiliary geometric surface; 32-auxiliary geometric center; 33-auxiliary geometric face edge; 4-a flow sensor; 5-a pressure sensor; 6-a controller; 61-a control chip; 62-a pressure unit; 63-a signal transceiver unit; 621-air bag; 622-pressure ball; a-blood vessels; a 1-puncture point; c-limb; c-a simulation system; c1-pulse motor; c2-water pipe; c3-artificial fistula; c4-motor; c5-water storage tank; c6-check valve; c7-pressure gauge; C8-Doppler ultrasound; c9-single point hemostat; c10-two-point hemostat; c11-four-point equidistant hemostatic member; c12-pressure gauge; c13-simulated puncture points; d1, D2-distance; l1, L2-shortest distance.

Detailed Description

Referring to fig. 1 and 2, the hemostatic method of the present invention may be performed by a hemostatic device comprising: the hemostatic device comprises a body 1, a main hemostatic piece 2, at least one auxiliary hemostatic piece 3, a flow sensor 4, a pressure sensor 5 and a controller 6.

The body 1 is provided with a belt 11. The body 1 is provided with a hemostatic surface 12.

A main hemostatic member 2 disposed on the hemostatic surface 12. The primary hemostatic member 2 has a primary geometric surface 21, the primary geometric surface 21 having a primary geometric center 22 and a primary geometric surface edge 23.

At least one auxiliary hemostatic member 3 disposed on the hemostatic surface 12. The auxiliary hemostatic members 3 each have an auxiliary geometric surface 31, the auxiliary geometric surface 31 having an auxiliary geometric center 32 and an auxiliary geometric surface edge 33.

As shown in FIGS. 3 and 4, the embodiment of the present invention has a main hemostatic member 2 and two auxiliary hemostatic members 3, and the distances (D1), (D2) between the main geometric center 22 and the auxiliary geometric centers 32 may be equal or different. In the present embodiment, the distances D1, D2 between the main geometric center 22 and the auxiliary geometric centers 32 are between 0.5 cm and 3.5 cm; the shortest distances L1, L2 between the main geometric face edge 23 and the auxiliary geometric face edges 33 are greater than 0 cm and less than 3.5 cm. To avoid the auxiliary geometric center 32 being too far from the main geometric center 22 to lose the hemostatic effect of the auxiliary compression.

As shown in fig. 2, 3 and 5, the flow sensor 4 is disposed on the hemostasis surface 12 and can be used to detect the normal flow velocity of a blood vessel a and the flow velocity during hemostasis, but the normal flow velocity is different for each person and can change with the physiological or psychological change. The flow sensor 4 may be an optical measuring device or an ultrasonic measuring device, and in the embodiment of the present invention, an optical measuring device is used.

The pressure sensor 5 is disposed on the hemostatic surface 12 and is capable of detecting a systolic pressure generated by the blood flow in the blood vessel a.

As shown in fig. 2 and 5, the controller 6 is disposed inside the main body 1, and the controller 6 has a control chip 61 electrically connected to the flow sensor 4 and the pressure sensor 5 and capable of outputting a control signal, a pressure unit 62 electrically connected to the control chip 61, and a signal transceiver unit 63 electrically connected to the control chip 61 and capable of transmitting the control signal output by the control chip 61 to the outside. Wherein the pressure unit 62 may be a manual mode or an automatic mode. When the pressure unit 62 is a manual sample, it may have an air bag 621 capable of linking the main hemostatic member 2 and the auxiliary hemostatic members 3, a pressurizing ball 622 connected to the air bag 621, a pressure relief valve (not shown) connected to the air bag 621 and electrically connected to the control chip 61, and a pressure gauge (not shown) exposed to the outside for displaying pressure value. The pressurizing ball 622 can provide manual pressing to inflate the air bag 621, so that the main hemostatic member 2 and the two auxiliary hemostatic members 3 can apply a hemostatic pressure outside the puncture point through manual operation of the pressurizing device via the air bag 621. In the present embodiment, a manual movement pattern is used for illustration.

In addition, when the pressure unit 62 is self-dynamic, it may have a pressurizing member (not shown) capable of linking the main hemostatic member 2 and the auxiliary hemostatic members 3, and a motor (not shown) electrically connected to the control chip 61 and capable of driving the pressurizing member. The motor is controlled by the control chip 61 to drive the pressurizing member in time, and the pressurizing device is controlled by the computer program to apply a hemostasis pressure to the main hemostatic member 2 and apply a hemostasis pressure to the outside of the puncture point to the two auxiliary hemostatic members 3.

As shown in fig. 1-3 and 6, the present invention can be implemented by first performing the following preliminary steps, i.e., obtaining a systolic pressure of a blood vessel and a normal flow rate of blood in the blood vessel. The hemostasis method provided by the embodiment of the invention can be suitable for radial artery hemostasis after coronary angioplasty, arteriovenous fistula hemostasis after renal lavage of a renal patient, pressurization hemostasis when a limb arteriovenous catheter is pulled out and the like. In this example, the hemostasis of the blood vessel (i.e., fistula) A after completion of renal washing in a renal washing patient is described. After hemodialysis treatment, the caregiver removes the puncture needle from blood vessel a, and immediately presses the puncture point a1 with a cotton cloth cover to make a single point press, and after the blood is stabilized, the band 11 is tied and positioned on the limb B of the patient, and the main hemostatic member 2 of the hemostatic device is pressed against the puncture point a1, and the two auxiliary hemostatic members 3 are pressed against the positions near the puncture point a 1. The flow sensor 4 is used to detect the change of the normal flow velocity of the blood in the blood vessel a at any time, and the pressure sensor 5 also detects the systolic pressure generated by the blood flow in the puncture point a 1. Besides the above-mentioned hemostasis, the systolic pressure can be measured simultaneously, or the historical average record of the patient can be established by means of a database, and can be used as the reference value of the systolic pressure.

The hemostasis method provided by the embodiment of the invention comprises the following steps: A. applying a main geometric surface to a puncture point hemostasis pressure on a puncture point of the blood vessel, and applying at least one auxiliary geometric surface to at least one puncture point external hemostasis pressure on a position outside the puncture point, wherein the puncture point external hemostasis pressure directly or indirectly acts on the blood vessel. As shown in fig. 2, 3 and 5, the pressurizing ball 622 is manually pressed to inflate the balloon 621, and the pressure unit 62 is controlled to output hemostatic pressure to the main hemostatic member 2 and the two auxiliary hemostatic members 3 by manually operating a pressurizing device, so that the main hemostatic member 2 applies a puncture hemostatic pressure to the puncture point a1 through the main geometric surface 21. The two auxiliary hemostatic members 3 are pressed by the auxiliary geometric surface 31 to the position near the puncture point a1 for pressurized hemostasis. Wherein the value of the hemostatic pressure applied outside the puncture site is the same as the hemostatic pressure applied to the puncture site in this embodiment.

B. In the process of hemostasis, obtaining a flow velocity of blood in the blood vessel during hemostasis, and simultaneously applying pressure through the hemostasis pressure of the puncture point and the hemostasis pressure outside the puncture point to enable the value of the flow velocity during hemostasis to be lower than the value of the normal flow velocity, wherein the hemostasis pressure of the puncture point and the hemostasis pressure outside the puncture point are lower than the systolic pressure. The flow sensor 4 is then used to detect the flow velocity of the blood in the blood vessel a at any time, so as to obtain the flow velocity during the hemostasis for multiple times, and according to the value of the flow velocity during the hemostasis obtained each time, the hemostasis pressure of the puncture point a1 and/or the hemostasis pressure outside the puncture point are/is changed manually in the hemostasis process, the main geometric surface 21 is used to directly apply the hemostasis pressure of the puncture point to the puncture point a1, the auxiliary geometric surface 31 is located at the position 0.5 cm to 3.5 cm outside the puncture point, the hemostasis pressure outside the puncture point is applied, and the hemostasis pressure of the puncture point and the hemostasis pressure outside the puncture point are both lower than the systolic pressure. In this embodiment, the flow rate during hemostasis is made to have a value that is less than 60% of the normal flow rate value. The hemostasis action can be finished until the hemostasis period is finished.

C. Message collection, message output and prompt comparison result. Collecting, by the control unit of the controller 6, during hemostasis, one or a combination of the following messages: the hemostasis pressure of the puncture point, the external hemostasis pressure of the puncture point, the flow rate during hemostasis, the contraction pressure, the hemostasis operation time, the working temperature of a main geometric surface and the working temperature of an auxiliary geometric surface. The controller 6 generates a message output step to transmit the collected result of the message collection step through the signal transceiver 63. And comparing the collected result of the message collection step with a default value, and selectively outputting a prompt signal according to the comparison result. The prompt signal is displayed on the body 1 or output to a remote portable electronic device (such as a smart phone) for display.

As shown in fig. 7, the primary hemostatic member 2 and the secondary hemostatic member 3 are not located on the same straight line. However, the distances D1, D2 between each main geometric center 22 and the auxiliary geometric centers 32 are still equidistant, and each auxiliary hemostatic device 3 is adjacent to the main hemostatic device 2. In the embodiment shown in fig. 7, the main hemostatic member 2 directly presses the puncture site of the blood vessel a, and the two auxiliary hemostatic members 3 press beside the blood vessel a, so as to still generate a pressurized hemostatic effect on the blood vessel a, thereby achieving the same pressurized hemostatic effect.

As shown in fig. 8, the auxiliary hemostatic member 3 is provided as one and is located on the same straight line of the blood vessel a as the main hemostatic member 2. Therefore, in use, the main hemostatic member 2 and the auxiliary hemostatic member 3 can still exert a pressurized hemostatic effect on the blood vessel a, thereby achieving the same pressurized hemostatic effect.

As shown in fig. 9, the auxiliary hemostatic member 3 is provided as one and is always on-line, unlike the main hemostatic member 2, which is located in the blood vessel a. Therefore, in use, the main hemostatic member 2 and the auxiliary hemostatic member 3 can still exert a pressurized hemostatic effect on the blood vessel a, thereby achieving the same pressurized hemostatic effect.

As shown in fig. 10, in the simulated experimental environment, a single point pressure, a two point pressure and a multi point (four point) pressure are applied to a flexible fluid pipeline, and the results show that the two point pressure and the four point pressure have more remarkable effects on reducing the flow rate than the single point pressure under the same applied pressure. Taking the pressure of 120mmHg as an example, a single point of pressure decreased the flow rate by 19.7%, a two point of pressure decreased the flow rate by 50.4%, and a four point of pressure decreased the flow rate by 81.6%. In addition, the method of the embodiment of the invention can apply pressure through two or more points (four points), namely, one main hemostatic member 2 is used for pressing the puncture point A1 and at least more than one auxiliary hemostatic members 3 are used for pressing the positions near the puncture point A1. The pressure applied by the traditional single-point pressure application is improved to be more than 200mmHg mostly to ensure the hemostasis effect, but the excessive pressure application causes the blood vessel damage or the ischemia injury of the rear tissue. In addition, when the flow rate is reduced to 60%, blood can still flow smoothly, i.e. the flow rate reduction amount for effective hemostasis can be obtained, but the difference between the patient body and the wound condition still exists, and when the flow rate is reduced to 60%, it is obvious that the pressure value required by two-point pressurization is close to 140mmHg, and the pressure value required by multi-point (four-point) pressurization is only close to 100mmHg, so that it can be known that the hemostasis mode of two-point or multi-point (four-point) pressurization can achieve good pressurization hemostasis effect without applying excessive pressure (more than 200 mmHg).

The hemostasis method provided by the embodiment of the invention has a wide application range, and can be applied to radial artery hemostasis after coronary angioplasty, arteriovenous fistula hemostasis after renal washing of a renal patient, pressure hemostasis during limb arteriovenous catheter removal and the like. The operation is simple, the use convenience is good, the fistula can be effectively protected from being excessively pressed in the process of pressurizing hemostasis, the impact on the fistula and the complication of the fistula are reduced, the fistula reconstruction rate is reduced, and the life safety of a patient is guaranteed. In addition, the hemostasis device disclosed by the embodiment of the invention has a pressure measurement function, so that the pressure application amount can be fed back in real time and is displayed by the hemostasis device or other portable electronic devices (such as a smart phone), so that a patient can carry the hemostasis device according to the pressure value set by clinical medical personnel and can obtain a hemostasis result by watching a display screen arranged on the hemostasis device, and meanwhile, the hemostasis device can provide physiological parameters measured on blood vessels, such as blood flow rate, blood vessel pulsation or blood oxygen value, so that the patient can know the current health condition of the body and the blood vessels.

As shown in fig. 3 and 5, the controller 6 of the hemostatic device may further include a timing unit (not shown) electrically connected to the control chip 61 to provide a hemostatic timing function, when the hemostatic time is expired, the control chip 61 controls the pressure unit 62 to release the pressure, so that the main hemostatic member 2 and the auxiliary hemostatic member 3 release the pressure applied to the puncture site a1 and the position near the puncture site a1, thereby minimizing the injury of pressurizing the blood vessel a. Furthermore, the controller 6 may further link with a cloud database via the internet to obtain the care recommendation data uploaded remotely, for example, a caregiver at a remote location may provide a recommended hemostasis time according to the physical condition or medication condition of the patient, such as a patient taking anticoagulant drugs, which is recommended to prolong the hemostasis time by 2 hours.

To prove that the embodiment of the present invention can be realized without applying excessive hemostatic pressure, and the pressurized hemostasis effect can be achieved, please refer to the following simulation experiment of hemostasis and pressurization.

As shown in FIG. 11, a closed simulation system C is constructed in advance, and a pulse motor C1 is used to simulate the condition of heart beat. And a two-way pipe C2 is provided to simulate veins and arteries of a human body. And a soft artificial fistula C3 is connected between the two water pipes C2 to simulate a fistula, and a motor C4 and a water storage tank C5 are respectively connected to the front end of the artificial fistula C3 to form a loop. And inputting a liquid to simulate blood, wherein the liquid can be artificial blood or saline, and the viscosity number of the liquid is increased by adding corn starch. Before the motor C4 and the blood flow back to the water storage tank C5, a check valve C6 capable of adjusting water flow is respectively installed for water change and pressure adjustment of the simulation system C. And the artificial fistula C3 was pressure-measured with a pressure gauge C7. A Doppler ultrasound C8 was also used to detect the flow rate of blood through the artificial fistula C3.

As shown in fig. 12-14, a mold with a bump is used to simulate a single point hemostat C9, a mold with two bumps is used to simulate a two point hemostat C10, and a mold with four bumps with equal distances is used to simulate a four point equidistant hemostat C11. As shown in fig. 15 to 17, a pressure gauge C12 is further combined with the single-point hemostatic member C9, the two-point hemostatic member C10 and the four-point equidistant hemostatic member C11, respectively, to simulate the hemostasis state of performing single-point pressure, two-point pressure and four-point equidistant pressure on a simulated puncture point C13 of the artificial fistula C3. In the above simulation, the comparative curves of the pressure values and the descending flow rate obtained by the single-point pressing, the two-point pressing and the four-point pressing are shown in fig. 10.

The foregoing description is intended to be illustrative rather than limiting, and it will be appreciated by those skilled in the art that many modifications, variations, or equivalents may be made without departing from the spirit and scope of the invention as defined in the appended claims.

Claims

1. A hemostasis device comprises a body provided with a bridle, a main hemostasis piece and at least one auxiliary hemostasis piece, and is characterized in that:

the body is provided with a hemostatic surface;

the main hemostatic piece is arranged on the hemostatic surface and is provided with a main geometric surface which is provided with a main geometric center and a main geometric surface edge;

the at least one auxiliary hemostatic piece is arranged on the hemostatic surface and is provided with an auxiliary geometric surface, the auxiliary geometric surface is provided with an auxiliary geometric center and an auxiliary geometric surface edge, the distance between the main geometric center and the auxiliary geometric center is 0.5 cm to 3.5 cm, the shortest distance between the main geometric surface edge and the auxiliary geometric surface edge is more than 0 cm and less than 3.5 cm, and the main geometric center and the auxiliary geometric center are equidistant or not equidistant;

the hemostatic device further comprises:

a flow sensor arranged on the hemostasis surface and used for detecting a normal flow velocity of a blood vessel and a flow velocity during hemostasis;

a pressure sensor arranged on the hemostasis surface and used for detecting a systolic pressure generated by the blood flow in the blood vessel;

a controller, locate inside this body, this controller has this flow sensor of electric connection and this pressure sensor and a control chip of an output control signal, a pressure unit of this control chip of electric connection, and a signal transceiver unit of this control chip of electric connection and this control chip output this control signal transmission in the external world, this pressure unit has an gasbag that links this main hemostatic piece and this supplementary hemostatic piece, a pressurization ball that links this gasbag, a relief valve that links this gasbag and this control chip electric connection, and externally expose and be used for showing the pressure gauge of pressure numerical value, this pressurization ball is aerifyd to this gasbag, in order to carry out the following step:

A. applying a puncture point hemostasis pressure to a puncture point of the blood vessel by using the main geometric surface, and applying at least one puncture point external hemostasis pressure to a position outside the puncture point by using the auxiliary geometric surface, wherein the puncture point external hemostasis pressure directly or indirectly acts on the blood vessel;

B. in the hemostasis process, obtaining the flow velocity of blood in the blood vessel during hemostasis, and simultaneously applying pressure through the hemostasis pressure of the puncture point and the hemostasis pressure outside the puncture point to ensure that the value of the flow velocity during hemostasis is lower than 60% of the value of the normal flow velocity of the blood vessel, wherein the hemostasis pressure of the puncture point and the hemostasis pressure outside the puncture point are lower than the systolic pressure of the blood vessel, so that the value of the flow velocity during hemostasis is lower than the value of the normal flow velocity; and

wherein, the value of the hemostasis pressure outside the puncture point is the same as that of the hemostasis pressure of the puncture point.

2. The hemostatic device according to claim 1, wherein in step B, the flow rate during hemostasis is obtained multiple times, and the hemostasis pressure at the puncture point or/and the hemostasis pressure outside the puncture point is changed correspondingly during hemostasis according to the value of the flow rate during hemostasis obtained each time.

3. The hemostatic device according to claim 1, wherein step B uses an optical or ultrasonic meter to obtain the flow rate during hemostasis.

4. The hemostatic device according to claim 1, wherein hemostatic pressure is imparted to the puncture site and to the outside of the puncture site by manually operating a pressurizing means.

5. The hemostatic device according to claim 1, wherein a pressurizing means is controlled by a computer program to provide a hemostatic pressure to the puncture site and a hemostatic pressure outside the puncture site.

6. The hemostatic device according to claim 1, further comprising a step C of collecting information, wherein during hemostasis, a controller collects one or a combination of the following information: the hemostasis pressure of the puncture point, the external hemostasis pressure of the puncture point, the flow rate during hemostasis, the contraction pressure, the hemostasis operation time, the working temperature of a main geometric surface and the working temperature of an auxiliary geometric surface.

7. The hemostatic device according to claim 6, wherein step C comprises a message output step for transmitting the results collected by the message collection step to the controller.

8. The hemostatic device according to claim 6, wherein the step C comprises a prompt step of comparing the collected results of the message collection step with a default value and selectively outputting a prompt signal according to the comparison result.