Hemostasis support system

Abstract

To provide a hemostatic procedure assistance system that can more reliably prevent complete occlusion of blood vessels during hemostasis procedures. [Solution] The hemostasis operation assistance system 100 includes a detection unit 130 that detects information about blood flow before the hemostasis operation begins, a control unit 140 that determines compression conditions based on the detection result of the detection unit, and a drive unit 150 that adjusts the amount of compression according to the compression conditions.

Description

Technical Field

[0005]

[0001] The present invention relates to a hemostasis operation assistance system.

Background Art

[0002] As one of the catheter techniques, a technique is known in which a blood vessel such as the radial artery located in the patient's arm, hand, wrist, etc. is punctured, and various medical long bodies are introduced into the blood vessel through the puncture site formed in the patient's arm blood vessel, and treatment or treatment for the lesion site is performed. Such a technique is also called the TRI (Trans-Radial Intervention) method.

[0003] After performing the above technique, generally, a hemostasis device is used to apply a compressive force to the puncture site (hemostasis site) to perform hemostasis. For example, as a conventionally existing hemostasis device, a hemostasis device provided with an expansion part (for example, a balloon) capable of applying a compressive force to the puncture site of a patient (hereinafter, also described as "hemostasis target person") is known. In compression hemostasis using a hemostasis device, in order to prevent the blood vessel such as the radial artery from being completely blocked during the hemostasis operation and maintain open hemostasis in which the hemostasis operation is performed while maintaining a certain amount of blood flow in the blood vessel, a compression protocol in which the compressive force of the expansion part is changed over time and stepwise may be adopted.

[0004] For example, in Patent Document 1, a medical system is proposed that is configured to calculate a compression protocol based on biometric information acquired from a patient, adjust the compression method of the hemostasis device based on the calculated compression protocol, and further present a medical intervention method for the patient based on the biometric information (for example, an intervention method regarding postoperative medication for the patient).

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

[0006] As a result of diligent research, the inventors have obtained knowledge of a hemostatic method that can more reliably prevent complete occlusion of blood vessels during hemostatic procedures, and have completed the present invention.

[0007] The present invention aims to provide a hemostatic procedure assistance system that can more reliably prevent complete occlusion of blood vessels during hemostasis procedures. [Means for solving the problem]

[0008] The above objective is achieved by any one of the following embodiments (1) to (14) of the present invention.

[0009] (1) A hemostatic procedure assistance system for applying pressure to stop bleeding, A detection unit that detects information about blood flow before starting hemostasis procedures, A control unit that determines the compression conditions based on the detection result of the detection unit, A hemostatic operation assistance system comprising a drive unit that adjusts the amount of compression according to the aforementioned compression conditions.

[0010] (2) The hemostatic operation assistance system according to (1), wherein the detection unit is a blood flow sensor.

[0011] (3) The hemostatic operation assistance system according to (1) or (2), wherein the detection unit is configured to detect information regarding blood flow even after the hemostatic operation has started.

[0012] (4) The hemostasis operation assistance system according to any one of (1) to (3), wherein the control unit classifies the compression conditions into at least two groups based on the biological information of the person to be hemostatically controlled acquired in advance and the blood flow information detected by the detection unit, and then determines the compression conditions.

[0013] (5) The compression condition includes a compression amount that enables compression hemostasis and still maintains blood flow without completely occluding the blood vessel, and the hemostasis operation assisting system according to any one of (1) to (4).

[0014] (6) The compression condition further includes the time for maintaining the compression amount, and the hemostasis operation assisting system according to (5).

[0015] (7) The driving part is configured to adjust the compression amount until the determined compression condition is achieved and maintain the compression amount when the compression condition is reached, and the hemostasis operation assisting system according to any one of (1) to (6).

[0016] (8) The hemostasis operation assisting system is used together with a hemostasis device that performs compression hemostasis by injecting a fluid, The driving part is configured to drive to inject the fluid into the hemostasis device, and the hemostasis operation assisting system according to any one of (1) to (7).

[0017] (9) The driving part consists of a diaphragm pump, and the hemostasis operation assisting system according to (8).

[0018] (10) The hemostasis operation assisting system includes a connection part for detachably connecting to the fluid injection part of the hemostasis device, and the hemostasis operation assisting system according to (8) or (9).

[0019] (11) The control part includes a feedback mechanism capable of readjusting the compression amount according to the detection result of the detection part during the hemostasis operation, and the hemostasis operation assisting system according to any one of (1) to (10).

[0020] (12) The control unit determines a compression protocol including the compression conditions, the hemostasis operation assistance system according to any one of (1) to (11).

[0021] (13) The compression protocol includes a maintenance time after achieving the compression conditions and decompression conditions after the lapse of the maintenance time, the hemostasis operation assistance system according to (12).

[0022] (14) The hemostasis operation assistance system according to (13) further includes an input unit that enables control of the change of the compression protocol and the driving of the driving unit according to the changed compression protocol.

Effect of the Invention

[0023] The above hemostasis operation assistance system detects information on the blood flow of the hemostasis target person before the start of the hemostasis operation, determines the compression conditions based on the detection result, and further adjusts the compression amount of the hemostasis device according to the compression conditions. The hemostasis operation assistance system can determine appropriate compression conditions for each hemostasis target person based on the information on the blood flow of the hemostasis target person acquired before the start of the hemostasis operation. Therefore, by using the hemostasis operation assistance system, it is possible to more reliably prevent the complete occlusion of blood vessels during the hemostasis operation and achieve appropriate open hemostasis.

Brief Description of the Drawings

[0024] [Figure 1] It is a perspective view of the hemostasis operation assistance system according to the embodiment. [Figure 2] It is a partially enlarged view of the hemostasis operation assistance system. [Figure 3] It is a block diagram of the hemostasis assistance operation system and a cross-sectional view schematically showing the usage state of the hemostasis device. [Figure 4] It is a diagram for explaining the usage procedure of the hemostasis operation assistance system. [Figure 5] It is a diagram for explaining the usage procedure of the hemostasis operation assistance system. [Figure 6]This is a diagram illustrating the procedure for using a hemostatic assistance system. [Figure 7] This is a flowchart illustrating the classification of control protocols performed by hemostasis assistance systems. [Figure 8] This is a flowchart of the control protocol executed by the hemostasis assistance system. [Modes for carrying out the invention]

[0025] Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown herein are illustrative examples to embody the technical idea of ​​the present invention and do not limit the present invention. Furthermore, all other implementable forms, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included in the scope and spirit of the present invention, as well as in the claims and their equivalents.

[0026] Furthermore, the drawings attached to this specification may be schematically represented with changes to scale, aspect ratio, shape, etc., from the actual object for the sake of illustration and ease of understanding, but these are merely examples and do not limit the interpretation of the present invention.

[0027] Furthermore, in the following explanations, ordinal numbers such as "1st" and "2nd" are used, but unless otherwise specified, they are used for convenience and do not prescribe any particular order.

[0028] The hemostatic operation assistance system 100 according to this embodiment will be described below with reference to Figures 1 to 8.

[0029] Figure 1 is a perspective view of the hemostasis assistance system 100. Figure 2 is a partially enlarged view showing a part of the hemostasis assistance system 100 (a part of the inner surface 112 of the attachment part 110). Figure 3 is a block diagram of the hemostasis assistance system 100 and a schematic cross-sectional view showing the usage state of the hemostasis device 200. Figures 4 to 6 are diagrams illustrating examples of the use of the hemostasis assistance system 100. Figures 7 and 8 are flowcharts showing the processing details of each step performed by the hemostasis assistance system 100 during a hemostasis operation.

[0030] <Hemostasis System 10> As shown in Figures 3 to 6, the hemostasis operation assistance system 100 according to this embodiment can constitute a hemostasis system 10 together with a hemostatic device 200. The hemostasis operation assistance system 100 can be used to assist the operation (operation assistance) of the hemostatic device 200 used for compression hemostasis of a hemostatic site pt formed on the person H to be hemostatic. The hemostasis operation assistance system 100 can also be used together with any hemostatic means (hemostatic instrument) other than the hemostatic device 200.

[0031] <Hemostasis Assistance System 100> As shown in Figures 1 and 2, the hemostasis operation assistance system 100 is a hemostasis operation assistance system for performing compression hemostasis, and comprises a detection unit 130 that detects information on blood flow before the start of the hemostasis operation, a control unit 140 that determines compression conditions (conditions relating to the amount of compression and hemostasis time necessary and sufficient for hemostasis while ensuring a constant amount of blood flow at the hemostasis site pt) based on the detection results of the detection unit 130, and a drive unit 150 that adjusts the amount of compression according to the compression conditions.

[0032] The hemostasis assistance system 100 can include determining the compression conditions when the hemostatic device 200 compresses the hemostasis site pt, and adjusting and readjusting the amount of compression (compression force) applied by the hemostatic device 200 to the hemostasis site pt.

[0033] As shown in Figures 1, 4 to 6, the hemostasis assistance system 100 includes a mounting part 110 that is configured to be attached to the body of the person H to be hemostatic.

[0034] The attachment portion 110 can be configured to have an inner circumferential space 117 through which a part of the body of the person H to be hemostatic can pass. As shown in Figures 4 to 6, the attachment portion 110 can be attached to the person H by passing a part of the body of the person H (for example, a part of limb Ar such as the wrist or forearm) through the space 117.

[0035] There are no particular restrictions on the specific location (site) where the hemostasis assistance system 100 is attached to the body of the person H to be hemostasised. For example, any site can be selected that is a predetermined distance from the hemostasis site pt on the body of the person H to be hemostasised by the hemostasis device 200. However, in order to more accurately detect information about blood flow during the hemostasis procedure, it is preferable to attach it as close as possible to the hemostasis device 200.

[0036] The attachment portion 110 can be configured to be wrapped around a part of the body of the person H to be treated for hemostasis, for example, to form a space 117. One end and the other end of the attachment portion 110 in the wrapping direction can be configured to be connectable and detachable.

[0037] The attachment portion 110 may be provided with fixing portions 113a and 113b to enable the attachment portion 110 to be fixed to the body of the person H receiving hemostasis. Each fixing portion 113a and 113b can be positioned at one end and the other end of the attachment portion 110 and can be configured to be connectable and separable from each other. Medical personnel or the person H receiving hemostasis can fix the attachment portion 110 to a part of the body by connecting the fixing portions 113a and 113b to each other while the attachment portion 110 is positioned on a part of the body of the person H receiving hemostasis.

[0038] Each fixing part 113a, 113b can be made up of, for example, a mechanical connection mechanism, hook-and-loop fastener, etc., and there are no particular restrictions on the specific structure.

[0039] The mounting portion 110 can be made of, for example, a hard resin having a predetermined rigidity. However, there are no particular restrictions on the specific materials used for the mounting portion 110. Furthermore, the mounting portion 110 may have a wrist-mounted device configuration, such as a wristwatch.

[0040] The hemostasis assistance system 100 includes a storage unit 120 for storing a CPU, blood flow detection, and various elements and components that perform various calculations.

[0041] The storage section 120 can be provided, for example, at any position on the outer surface 111 of the mounting section 110. By storing various elements and components in the storage section 120, it is possible to prevent malfunctions or failures of the elements and components when the mounting section 110 is subjected to external impacts or other forces.

[0042] In this embodiment, the storage unit 120 houses a CPU (Central Processing Unit) that functions as a control unit 140 and an input unit 160, memory such as RAM (Random Access Memory) and ROM (Read Only Memory), a storage unit (for example, an HDD (Hard Disc Drive) or SSD (Solid State Drive)), a part of the detection unit 130, and a drive unit 150, etc.

[0043] As shown in Figure 2, the detection unit 130 is positioned such that its detection end 131 is located on the inner surface 112 of the attachment unit 110. By positioning the detection end 131 of the detection unit 130 in this way, when the attachment unit 110 is attached to the body of the person H to be hemostatic, the detection end 131 can be positioned to face the surface of the body of the person H to be hemostatic. Therefore, the detection unit 130 can easily detect blood flow in blood vessels v such as the radial artery.

[0044] The detection unit 130 can be configured as, for example, a blood flow sensor. By configuring the detection unit 130 as a blood flow sensor, it becomes possible to detect blood flow in blood vessel v with higher accuracy.

[0045] There are no particular restrictions on the blood flow sensor that constitutes the detection unit 130, but for example, an ultrasonic sensor can be used. For example, an ultrasonic sensor that emits 8 MHz ultrasonic waves from the detection end 131 and is configured to detect blood flow by ultrasonic Doppler can be used. Note that the frequency of the ultrasonic waves emitted from the ultrasonic sensor is not limited to 8 MHz and may be changed to any frequency depending on the location of the target blood vessel v.

[0046] Furthermore, the detection unit 130 is not particularly limited in terms of its specific type, as long as it can detect blood flow in the blood vessels v running through the body of the person H being targeted for hemostasis. For example, it can be composed of a known optical sensor.

[0047] The detection unit 130 is configured to detect blood flow before the start of the hemostasis operation. The hemostasis operation assistance system 100 can set appropriate compression conditions based on the blood flow acquired by the detection unit 130 before the start of the hemostasis operation. Therefore, the hemostasis operation assistance system 100 can effectively prevent the blood vessel v from becoming completely occluded immediately after the start of the hemostasis operation, and can perform the hemostasis operation while ensuring a constant blood flow.

[0048] Furthermore, the detection unit 130 can be configured to detect information regarding blood flow even after the hemostasis operation has started. The hemostasis operation assistance system 100 can be configured to perform feedback control to adjust the compression conditions based on the blood flow information acquired by the detection unit 130 after the hemostasis operation has started. As a result, the hemostasis operation assistance system 100 can apply an appropriate compression force to the hemostasis site pt while preventing complete occlusion of the blood vessel v even after the hemostasis operation has started and has been continued for a predetermined time.

[0049] The drive unit 150 supplies and discharges fluid (for example, a gas such as air) to operate the expansion and contraction of the expansion portion 210 of the hemostatic device 200.

[0050] The drive unit 150 can be configured, for example, as a diaphragm pump. By configuring the drive unit 150 as a diaphragm pump, the drive unit 150 can be made smaller, and the supply and discharge of a predetermined amount of fluid can be achieved with high precision.

[0051] Furthermore, the drive unit 150 is not particularly limited in terms of its specific type, as long as it can expand and contract the expansion portion 210 of the hemostatic device 200. For example, it can be composed of a centrifugal pump or a peristaltic pump.

[0052] As shown in Figure 1, the hemostatic operation assistance system 100 includes a connection part 115 for detachably connecting to the fluid injection part 250 of the hemostatic device 200.

[0053] The connection part 115 can be positioned, for example, near the storage part 120 in which the drive unit 150 is housed.

[0054] The connection portion 115 is in fluid communication with the drive unit 150. The connection portion 115 has the function of ensuring fluid communication between the drive unit 150 and the expansion portion 210 of the hemostatic device 200.

[0055] A tube 170 is connected to the connection part 115 to allow fluid movement. A connector part 180 is attached to one end of the tube 170, which can be connected to the fluid injection part 250 of the hemostatic device 200.

[0056] When initiating a hemostatic operation using the hemostatic device 200, the hemostatic operation assistance system 100 connects the connector portion 180 to the fluid injection portion 250, thereby enabling control of the fluid supply to the expansion portion 210 by the drive unit 150 and the fluid discharge from the expansion portion 210.

[0057] Furthermore, there are no particular restrictions on the material, length, outer diameter, and inner diameter of the tube 170, as long as it can move a predetermined amount of fluid. Similarly, there are no particular restrictions on the material and structure of the connector part 180, as long as it can be connected to and separated from the fluid injection part 250.

[0058] As shown in Figure 3, the control unit 140 is configured to comprehensively control each part of the hemostasis operation assistance system 100. The control unit 140 is configured to execute predetermined operation processes related to hemostasis by reading a series of programs necessary for controlling the operation of the hemostasis operation assistance system 100 stored in a storage unit (e.g., HDD or SSD).

[0059] The control unit 140 can classify the compression conditions of the hemostatic device 200 into at least two groups based on the biological information (patient information) of the person to be hemostatically controlled H acquired in advance prior to the hemostatic operation and the blood flow information detected by the detection unit 130, and then determine the compression conditions.

[0060] The "biometric information" mentioned above includes, for example, the gender, age, height, and weight of the person to be hemostatic, obtained from electronic medical records, as well as information related to the blood flow of person H (a high-risk factor for vascular occlusion). This information may include blood pressure (whether or not it is hypotension), arm diameter, BMI, presence or absence of arteriosclerosis (including whether or not hemodialysis has been performed), and a history of PCI surgery. The control unit 140 determines appropriate compression conditions according to the specific circumstances of person H to be hemostatic, based on the biological information and the blood flow information detected by the detection unit 130. Therefore, the hemostatic operation assistance system 100 can achieve hemostatic operation under more optimal compression conditions.

[0061] Furthermore, the hemostasis procedure assistance system 100 can acquire the vital signs of the patient H from the in-hospital electronic medical record system or the like prior to the hemostasis procedure, or it can acquire the vital signs of the patient H through input from medical personnel or the patient H.

[0062] The compression conditions determined by the control unit 140 include a compression amount that allows for compression hemostasis while maintaining blood flow without completely occluding the blood vessel. Therefore, by using the hemostasis operation assistance system 100, the control unit 140 can automatically determine the compression force as described above. This makes it possible to set an appropriate compression amount without relying on the experience of medical personnel, which is expected to reduce the risk of complications due to excessive compression. Furthermore, it eliminates the need for medical personnel and the patient H to adjust the compression force, thus improving the efficiency of medical operations.

[0063] The compression conditions determined by the control unit 140 may further include the time for maintaining the compression amount. Therefore, by using the hemostasis operation assistance system 100, it becomes possible to perform hemostasis with an appropriate compression amount maintenance period. Thus, it becomes possible to achieve more optimal compression hemostasis. The compression conditions may also include the time required to reach a predetermined compression amount.

[0064] The control unit 140 can be configured to include a feedback mechanism that allows the amount of compression to be readjusted according to the detection result (output) of the detection unit 130 during the hemostasis operation. Therefore, the hemostasis operation assistance system 100 can readjust the compression force to an appropriate size while the hemostasis operation is being performed. For example, if the hemostasis operation is being performed with an excessively large amount of compression, and the detection unit 130 detects such a condition, the control unit 140 can control the operation of the drive unit 150 to reduce the amount of compression. Thus, the hemostasis operation assistance system 100 can apply an appropriate amount of compression to the hemostasis site pt that is sufficient for the hemostasis operation while preventing complete occlusion of the blood vessel v.

[0065] The control unit 140 can be configured to determine a compression protocol, including compression conditions. By configuring the hemostasis assistance system 100 to determine the compression protocol along with the compression conditions, it becomes possible to achieve more appropriate hemostasis.

[0066] The compression protocol determined by the control unit 140 may include the maintenance time after achieving the compression conditions and the decompression conditions after the maintenance time has elapsed. Therefore, the hemostasis operation assistance system 100 can perform hemostasis under predetermined compression conditions as well as hemostasis under appropriate decompression conditions according to the hemostatic state of the hemostasis site pt. This makes it possible for the hemostasis operation assistance system 100 to more effectively prevent complete occlusion of the blood vessel v during the hemostasis operation.

[0067] As shown in Figure 3, the hemostasis operation assistance system 100 may further include an input unit 160 that enables control over changes to the compression protocol and the operation of the drive unit 150 by the changed compression protocol.

[0068] The hemostasis assistance system 100, equipped with an input unit 160, allows the compression protocol determined by the control unit 140 to be arbitrarily changed by external input operations (for example, by medical personnel or the person H undergoing hemostasis). Since the hemostasis assistance system 100 can arbitrarily change the compression protocol in response to changes in the hemostasis state, user convenience is further improved.

[0069] The input unit 160 can be configured, for example, by an information receiving unit that accepts external input via wireless or wired communication. Alternatively, the input unit 160 can also be configured by, for example, an external input panel, display, or audio input means provided on the mounting unit 110.

[0070] As shown in Figure 3, the hemostasis system 10 may further include an imaging means 300 for photographing the hemostasis site pt during a hemostasis operation using the hemostasis operation assistance system 100 and the hemostasis device 200. The hemostasis operation assistance system 100 can acquire image information (image data) acquired by the imaging means 300, confirm the bleeding state of the hemostasis site pt based on that image information, and further control the operation of the drive unit 150 based on the bleeding state.

[0071] The imaging means 300 can be, for example, a known camera device capable of acquiring still image data and / or video data.

[0072] <Hemostatic device 200> Figures 3 to 6 show hemostatic devices 200. The hemostatic devices 200 described herein are examples and are not limited to those described herein.

[0073] The hemostasis operation assistance system 100 according to this embodiment can be used together with a hemostatic device 200 that performs compression hemostasis by injecting fluid. The drive unit 150 of the hemostasis operation assistance system 100 can be configured to drive (operate) to inject fluid into the hemostatic device 200.

[0074] As shown in Figure 3, the hemostatic device 200 includes an expandable portion 210 that expands and contracts in conjunction with the injection and discharge of fluid, a band portion 220 to which the expandable portion 210 is attached, a support plate 230 held by the band portion 220, a tube 240 connected to communicate with the lumen 210a of the expandable portion 210, a fluid injection portion 250 attached to one end of the tube 240, and an expansion confirmation balloon 260 positioned between the tube 240 and the fluid injection portion 250.

[0075] The expansion section 210 can be configured, for example, as a balloon having a lumen 210a. The expansion section 210 expands when fluid supplied from the drive unit 150 is injected into the lumen 210a via the tube 240. The expansion section 210 also deflates when the fluid injected into the lumen 210a is discharged by the drive unit 150.

[0076] The band portion 220 is configured to be wrapped around a part of the body of the person H to be treated for hemostasis. As shown in Figure 3, fixing portions 224a and 224b for fixing the band portion 220 to the body of the person H are positioned at predetermined locations on the band portion 220. Each fixing portion 224a and 224b can be made up of, for example, a mechanical connection mechanism, hook-and-loop fastener, etc., and there are no particular restrictions on the specific structure.

[0077] As shown in Figure 3, when the hemostatic device 200 has its band portion 220 wrapped around a part of the body of the person H to be hemostatic, and the expandable portion 210 is expanded, a compressive force can be applied from the expandable portion 210 to the hemostatic site pt.

[0078] As shown in Figure 3, a predetermined retaining member 223 is attached to the band portion 220. The retaining member 223 defines a gap between the band portion 220 and the support plate 230 for holding the support plate 230. The support plate 230 is made of a harder material than the band portion 220, and when the expansion portion 210 expands, it presses the expansion portion 210 against the body of the person H being treated for hemostasis, thereby assisting in the compression of the hemostasis site pt by the expansion portion 210.

[0079] The fluid injection section 250 is configured to be connectable to and detachable from the connector section 180 of the hemostasis operation assistance system 100. Inside the fluid injection section 250 is a check valve configured to close when the connector section 180 is not connected. By pushing the connector section 180 into the fluid injection section 250 and connecting them, the check valve can be opened, thereby enabling fluid communication between the drive section 150 and the lumen 210a of the expansion section 210.

[0080] When a predetermined amount or more of fluid flows into the lumen 210a of the expansion section 210, the fluid flows back from the expansion section 210 to the expansion confirmation balloon 260 via the tube 240. The expansion confirmation balloon 260 is configured to expand with the backflowing fluid. Medical personnel and the person being treated for hemostasis H can easily understand the expansion state of the expansion section 210 by visually confirming the expansion of the expansion confirmation balloon 260.

[0081] <Example of use of hemostasis assistance system 100> Next, we will explain the hemostasis procedure using the hemostasis assistance system 100. Below, we will explain the usage procedure shown in Figures 3 to 6 and the processing content (control algorithm) of the hemostasis assistance system 100 shown in Figures 7 and 8. Note that the procedures and other information described below are merely examples, and the usage procedure and method of the hemostasis assistance system 100 are not limited to what is described here.

[0082] First, I will explain the overall procedure for using the hemostasis assistance system 100.

[0083] Figure 4 shows the condition after the TRI method procedure has been completed on patient H, the patient being treated for hemostasis. In this example, the hemostasis site pt is the puncture site connecting the blood vessel v (e.g., radial artery) to the body surface, and is located near the wrist. The sheath tube 410 of the introducer 400 used for the TRI method procedure is inserted into the hemostasis site pt.

[0084] As shown in Figure 4, the worker (for example, a medical professional) aligns the expandable portion 210 with the hemostasis site pt and wraps the band portion 220 around the wrist to attach the hemostatic device 200 to the person H receiving hemostasis.

[0085] As shown in Figure 4, before expanding the expansion section 210 and starting the hemostasis procedure, the worker attaches the hemostasis assistance system 100 to a predetermined location on the person H to be hemostatic (for example, near the forearm, which is located more centrally than the wrist).

[0086] The detection unit 130 of the hemostasis operation assistance system 100 detects blood flow in a blood vessel v (e.g., radial artery) before the hemostasis operation by the hemostatic device 200 is initiated. The control unit 140 determines the compression conditions according to the detection result of the detection unit 130.

[0087] Next, as shown in Figure 5, the connector portion 180 of the hemostasis operation assistance system 100 is connected to the fluid injection portion 250 of the hemostasis device 200. With the connector portion 180 and the fluid injection portion 250 connected, the hemostasis operation assistance system 100 operates the drive unit 150 so that a hemostasis operation is started according to predetermined compression conditions. The drive unit 150 sends a predetermined amount of fluid into the lumen 210a of the expansion portion 210, expanding the expansion portion 210 to a predetermined amount of compression.

[0088] Next, as shown in Figure 6, after the expansion section 210 has expanded, the sheath tube 410 of the introducer 400 is withdrawn from the hemostasis site pt. As the expansion section 210 expands, a compressive force is applied from the expansion section 210 to the hemostasis site pt, and the hemostasis operation of the hemostasis site pt by the hemostatic device 200 begins. Once the hemostasis operation by the hemostatic device 200 has begun, hemostasis assistance is performed by the hemostatic operation assistance system 100 according to the processing details in Figures 7 and 8 described below.

[0089] <Classification of control protocols (compression conditions)> Figure 7 shows a flowchart of an algorithm for determining specific compression conditions based on the characteristics of patient H who is being treated for hemostasis.

[0090] The hemostasis assistance system 100 acquires the vital signs of the person H to be hemostatic when determining the compression conditions (step S1). The hemostasis assistance system 100 acquires the vital signs of the person H to be hemostatic from an electronic medical record or the like in advance before the hemostasis procedure by the hemostatic device 200 is started.

[0091] The hemostasis operation assistance system 100 acquires initial patient blood flow information Q1 before the hemostasis operation by the hemostatic device 200 is initiated (step S2). The detection unit 130 detects the initial patient blood flow information Q1 with the hemostasis operation assistance system 100 attached to the person H to be hemostatic (as shown in Figure 4) before the hemostasis operation by the hemostatic device 200 is initiated.

[0092] The control unit 140 calculates a score based on the biological information of the patient H being treated for hemostasis and the initial patient blood flow information Q1 (step S3). The score is calculated using an additive method, for example, by adding a certain value if the patient H being treated for hemostasis has high-risk factors for vascular occlusion. A higher score indicates a higher risk. For example, a patient with low blood flow is judged to have a relatively high risk of vascular occlusion, and this score is added accordingly.

[0093] The control unit 140 calculates a difference value, which is the calculated score minus a reference value (step S4). The reference value is a predetermined value determined according to information such as that of patients who did not develop vascular occlusion during hemostasis procedures, and can be stored in the memory unit in advance.

[0094] The control unit 140 compares the calculated difference value with a predetermined range X (step S5). Here, the predetermined range X can be set as, for example, a predetermined range that is recognized as an acceptable range relative to the reference value. If the difference value is significantly higher than the range X (range X << difference value) (step S5; Yes), it is presumed that the calculated score is an outlier. Therefore, steps S2 to S4 are repeated in order to recalculate the score. An outlier can be defined as any value, for example, when the difference value is three times or more larger than the upper limit of the range X.

[0095] If the difference value calculated in step S4 exceeds the upper limit of range X (difference value > range X), the control unit 140 determines that there is a high risk of vascular occlusion (step S6; Yes) and executes control protocol 1 according to predetermined compression conditions (step S7).

[0096] If the difference value calculated in step S4 is within the range X (difference value = range X), the control unit 140 determines that the risk of vascular occlusion is moderate (step S8; Yes) and executes control protocol 2 according to predetermined compression conditions (step S9).

[0097] If the difference value calculated in step S4 falls below the lower limit of range X (difference value < range X), the control unit 140 determines that the risk of vascular occlusion is low (step S10; Yes) and executes control protocol 3 according to predetermined compression conditions (step S11).

[0098] Furthermore, if the score distributions for the high-risk and low-risk groups follow a normal distribution, the standard group (difference value = range X) will represent scores that fall within a predetermined range (width) of the normal distribution.

[0099] As described above, the hemostasis assistance system 100 classifies compression conditions into at least two groups (in this embodiment, three groups: control protocols 1 to 3) based on a score calculated from the biological information of the person H to be hemostatic and the initial patient blood flow information Q1.

[0100] Each control protocol 1 to 3 includes control of the operation of the drive unit 150 to achieve predetermined compression conditions (compression amount, compression time, decompression amount) and / or predetermined compression protocols. Below, control protocol 1 will be described based on the flowchart shown in Figure 8. Note that each control protocol adjusts and sets the parameters related to the compression conditions and compression protocols according to the high-risk group, low-risk group, and standard group, respectively. Therefore, the processing flow of the control protocols for the other control protocols 2 and 3 can be set to be substantially the same as that of control protocol 1, which will be described below.

[0101] <Implementation of hemostatic procedures based on control protocols> As shown in Figure 8, the hemostasis assistance system 100 adjusts the compression amount of the expansion portion 210 to the initial compression amount P1 when the hemostasis operation by the hemostasis device 200 is initiated (step S101). The initial compression amount P1 is the compression amount specified in control protocol 1, which is classified based on the score described above.

[0102] Next, the hemostasis operation assistance system 100 detects the second patient blood flow information Q2 by the detection unit 130 while the hemostasis operation has started (step S102).

[0103] Next, the hemostasis operation assistance system 100 compares the initial patient blood flow information Q1 with the second patient blood flow information Q2 (step S103). If the second patient blood flow information Q2 detected when the hemostasis operation has started is lower than the initial patient blood flow information Q1 measured before the hemostasis operation started (second patient blood flow information Q2 < initial patient blood flow information Q1) (step S103; Yes), the decompression parameter D1 is added (step S104). The control unit 140 controls the operation of the drive unit 150 so that the amount of decompression takes the decompression parameter D1 into account.

[0104] The hemostasis assistance system 100 is attached at a predetermined distance from the hemostasis site pt, proximal to the body (see Figure 6). Therefore, it is assumed that the blood flow at the attachment site of the hemostasis assistance system 100 does not change significantly (is maintained at virtually the same level) before and after the start of the hemostasis procedure. Consequently, if the second patient blood flow information Q2 < initial patient blood flow information Q1 (i.e., blood flow after the start of the hemostasis procedure < blood flow before the start of the hemostasis procedure), it is expected that a near-complete occlusion of a vascular tissue has occurred near the hemostasis site pt, and that this has caused a decrease in blood flow at the attachment site of the hemostasis assistance system 100. For these reasons, if such a detection result occurs, the hemostasis assistance system 100 performs a hemostasis procedure using a compression protocol that adds a predetermined decompression parameter D1 to assist in resolving the vascular occlusion.

[0105] When compression hemostasis is performed using a compression protocol that includes the decompression parameter D1, the hemostasis assistance system 100 compares the initial patient blood flow information Q1 and the second patient blood flow information Q2 again (step S103).

[0106] If the determination in step S103 is No, the hemostasis operation assistance system 100 performs bleeding detection (step S105). Bleeding detection (presence or absence of bleeding from the hemostasis site pt) can be performed, for example, based on image information acquired by the imaging means 300.

[0107] If bleeding is detected (step S106; Yes), the pressure parameter A1 is added (step S107). The control unit 140 controls the operation of the drive unit 150 so that the amount of pressure is adjusted to take the pressure parameter A1 into consideration. At this time, the drive unit 150 supplies fluid to the expansion unit 210 and increases the amount of expansion of the expansion unit 210. The hemostasis operation assistance system 100 increases the compressive force on the hemostasis site pt by performing the hemostasis operation with a pressure that takes the pressure parameter A1 into consideration, thereby suppressing bleeding.

[0108] The hemostasis assistance system 100 performs bleeding detection again (step S106) when compression hemostasis is performed using a compression protocol with the pressurization parameter A1 added. If bleeding is not detected (step S106; No), hemostasis is initiated using a predetermined compression protocol (step S108). The compression protocol includes the amount of compression adjusted based on the processing up to this point, the time to maintain the compression (predetermined time T), the amount of decompression after the predetermined time T has elapsed (decompression protocol), etc. By performing hemostasis with an appropriate compression protocol, the hemostasis device 200 can apply an appropriate compressive force to the hemostasis site pt that can prevent complete occlusion of the blood vessel v and bleeding from the hemostasis site pt.

[0109] The hemostasis support system 100 can readjust the compression protocol after performing hemostasis using the compression protocol determined by step S108. The process for readjusting the compression protocol is substantially the same as in steps S102 to S106, so some explanation will be omitted below.

[0110] The hemostasis procedure assistance system 100 detects the third patient blood flow information Q3 by the detection unit 130 while the hemostasis procedure is being continued (step S109).

[0111] Next, the hemostasis operation assistance system 100 compares the initial patient blood flow information Q1 with the third patient blood flow information Q3 (step S110). If the third patient blood flow information Q3 detected while the hemostasis operation is ongoing is lower than the initial patient blood flow information Q1 detected before the start of the hemostasis operation (third patient blood flow information Q3 < initial patient blood flow information Q1) (step S110; Yes), the decompression parameter D2 is added (step S111). The control unit 140 controls the operation of the drive unit 150 so that the amount of decompression takes the decompression parameter D2 into consideration. As described above, by performing a hemostasis operation using a compression protocol that adds a predetermined decompression parameter D2, it becomes possible to resolve the condition even if vascular occlusion has occurred.

[0112] When compression hemostasis is performed using a compression protocol that includes the decompression parameter D2, the hemostasis assistance system 100 compares the initial patient blood flow information Q1 and the third patient blood flow information Q3 again (step S110).

[0113] If the determination in step S110 is No, the hemostatic operation assistance system 100 performs bleeding detection (step S112).

[0114] If bleeding is detected (step S113; Yes), the pressurization parameter A2 is added (step S114). The control unit 140 controls the operation of the drive unit 150 so that the pressurization amount takes into account the pressurization parameter A2.

[0115] The hemostasis support system 100 performs bleeding detection again (step S113) if hemostasis is performed using a compression protocol with added pressure parameter A2. If no bleeding is detected (step S113; No), the hemostasis procedure is started using the readjusted compression protocol.

[0116] Subsequently, the same compression protocol can be readjusted any number of times at predetermined intervals, thereby preventing complete occlusion of blood vessel v and bleeding from the hemostasis site pt, while completing hemostasis at the hemostasis site pt.

[0117] As explained above, by using the hemostasis assistance system 100, the occlusion state of blood vessel v during hemostasis can be detected based on the blood flow state of blood vessel v, and hemostasis can be achieved with appropriate compression conditions (compression protocol) according to the detection result. Therefore, the risk of vascular occlusion of blood vessel v (e.g., radial artery) due to the application of excessive compression force can be reduced. In particular, when performing hemostasis on patients with a relatively high risk of vascular occlusion, such as dialysis patients, it becomes possible to suitably ensure blood flow.

[0118] Furthermore, the hemostasis assistance system 100 is configured to automatically detect blood flow using the detection unit 130 and to implement an appropriate compression protocol that takes the detection results into consideration. Therefore, the hemostasis assistance system 100 can perform both patency hemostasis and hemostasis procedures, which were previously performed by medical professionals. Consequently, it can contribute to improving the quality of medical services provided by medical professionals. Specifically, it eliminates the need for medical professionals to intervene in patency hemostasis, which requires expertise and training experience in outpatient surgery wards, thus improving the efficiency of medical operations.

[0119] Furthermore, the hemostasis assistance system 100 can perform optimized hemostasis procedures for each patient H based on their biological information. Therefore, by using the hemostasis assistance system 100, the time required for hemostasis can be shortened, thereby improving the economic efficiency of medical care.

[0120] As described above, the hemostasis operation assistance system 100 according to this embodiment is a hemostasis operation assistance system for performing compression hemostasis, and comprises a detection unit 130 that detects information about blood flow before the start of the hemostasis operation, a control unit 140 that determines compression conditions based on the detection result of the detection unit 130, and a drive unit 150 that adjusts the amount of compression according to the compression conditions.

[0121] According to the hemostasis assistance system 100 of this embodiment, it is possible to detect information about the blood flow of the person to be hemostasised H before the start of the hemostasis operation, determine compression conditions based on the detection results, and further adjust the amount of compression of the hemostasis device 200 according to the compression conditions. The hemostasis assistance system 100 can determine appropriate compression conditions for each person to be hemostasised H based on the information about the blood flow of the person to be hemostasised H acquired before the start of the hemostasis operation. Therefore, by using the hemostasis assistance system 100, it is possible to more reliably prevent complete occlusion of the blood vessel v during the hemostasis operation and to achieve appropriate patency hemostasis.

[0122] Although the hemostatic procedure assistance system according to the present invention has been described through embodiments, the present invention is not limited to the configuration described in the embodiments and can be modified as appropriate based on the claims.

[0123] For example, the hemostasis assistance system can also be used when performing hemostasis on hemostatic sites other than the wrists and arms of the person being treated. Furthermore, the hemostasis assistance system is not limited in its specific configuration, as long as it comprises at least a detection unit, a control unit, and a drive unit. For example, the structure and shape of the attachment part illustrated can be arbitrarily changed.

[0124] In this embodiment, we described an example in which the hemostasis assistance system acquires the biological information of the person to be hemostasised when initiating hemostasis assistance, and classifies compression conditions (control protocol) based on the biological information of the person to be hemostasised and the blood flow information before initiating the hemostasis procedure (initial blood flow information). However, it is also possible for the hemostasis assistance system to be configured to determine compression conditions based only on the blood flow information before initiating the hemostasis procedure (initial blood flow information), without acquiring or referring to the acquired biological information of the person to be hemostasised. [Explanation of Symbols]

[0125] 10. Hemostatic System 100 Hemostasis Assistance System 110 Mounting part 115 Connection part 120 Storage Unit 130 Detection unit 131 Detection end 140 Control Unit 150 Drive unit 160 Input section 170 tubes 180 Connector section 200 hemostatic devices 210 Expansion section 220 Belt section 250 Fluid injection part 300 Imaging means 400 Introducers H. Patients requiring hemostasis pt Hemostasis site v blood vessels

Claims

1. A hemostatic procedure assistance system for applying pressure to stop bleeding, A detection unit that detects information about blood flow before starting hemostasis procedures, A control unit that determines the compression conditions based on the detection result of the detection unit, A hemostatic operation assistance system comprising a drive unit that adjusts the amount of compression according to the aforementioned compression conditions.

2. The hemostatic operation assistance system according to claim 1, wherein the detection unit is a blood flow sensor.

3. The hemostatic operation assistance system according to claim 1, wherein the detection unit is configured to detect information regarding blood flow even after the hemostatic operation has started.

4. The hemostasis operation assistance system according to claim 1, wherein the control unit classifies the compression conditions into at least two groups based on the biological information of the person to be hemostatically controlled acquired in advance and the blood flow information detected by the detection unit, and then determines the compression conditions.

5. The hemostatic operation assistance system according to claim 1, wherein the compression conditions include a compression amount that enables compression hemostasis and maintains blood flow without completely occluding the blood vessel.

6. The hemostatic operation assistance system according to claim 5, wherein the compression conditions further include the time for which the amount of compression is maintained.

7. The hemostatic operation assistance system according to claim 1, wherein the drive unit is configured to adjust the amount of compression until the determined compression condition is achieved, and to maintain the amount of compression once the compression condition is reached.

8. The aforementioned hemostatic operation assistance system is used in conjunction with a hemostatic device that performs compression hemostasis by injecting fluid. The hemostatic operation assistance system according to claim 1, wherein the drive unit drives the fluid to be injected into the hemostatic device.

9. The hemostatic operation assistance system according to claim 8, wherein the drive unit comprises a diaphragm pump.

10. The hemostatic operation assistance system according to claim 8, further comprising a connecting portion for detachably connecting to a fluid injection portion of the hemostatic device.

11. The hemostatic operation assistance system according to claim 1, wherein the control unit is equipped with a feedback mechanism that can readjust the amount of compression according to the detection result of the detection unit during the hemostatic operation.

12. The hemostatic operation assistance system according to claim 1, wherein the control unit determines a compression protocol including the compression conditions.

13. The hemostatic operation assistance system according to claim 12, wherein the compression protocol includes a maintenance time after achieving the compression conditions and depressurization conditions after the maintenance time has elapsed.

14. The hemostatic operation assistance system according to claim 13, further comprising an input unit that enables control of the change of the compression protocol and the driving of the drive unit by the changed compression protocol.

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