A system for the control of bleeding after coronary angiography

Abstract

The invention is a system for monitoring whether the patient is bleeding after coronary angiography, which reduces post-procedure complications by warning health care personnel when bleeding is detected instantaneously and at the times when bleeding control should be performed, comprising an oximeter (1) worn on the patient's finger that instantaneously measures the oxygen value in the blood, a wrist sleeve (3) worn on the patient's wrist that delivers a predetermined amount of pressure to the patient to detect whether there is bleeding, an air motor (8) that generates the pressure sent to the patient through the wrist sleeve (3), a micro-controller (9) that analyzes the oxygen values coming from the oximeter (1) and the pressure values delivered to the wrist sleeve (3), determines whether these values exceed the predetermined values as a result of the analysis, and generates a command to warn the health care personnel in case it detects that they exceed, a warning indicator (2), which, upon command from the micro-controller (9), provides a visual warning instantaneously when there is a deviation in the values of the oximeter (1) and wrist sleeve (3); and to ensure that the personnel attend to the patient when the time set by the health care personnel is over, a mute button (5) which, when pressed, stops the warnings coming from the warning indicator (2), an LCD display (4) showing the patient's health values and the system's running time, and a battery (7) to power the system.

Description

[0001] A SYSTEM FOR THE CONTROL OF BLEEDING AFTER CORONARY ANGIOGRAPHY

[0002] TECHNICAL FIELD

[0003] The invention relates generally to a system developed for the control of bleeding after angiography.

[0004] The invention relates in particular to a control and notification system for ensuring hemostasis after coronary angiography (CAG), which allows minimizing complications by monitoring oxygenation and periodically informing health care personnel with an audible warning at the times when bleeding control should be performed.

[0005] STATE OF THE ART

[0006] The prevalence of cardiovascular diseases (CVD), which are among chronic diseases, is increasing in the society and accordingly, the risk of mortality and morbidity in the society is also increasing. Cardiovascular diseases are considered the leading cause of death worldwide, claiming approximately 17.9 million lives each year. Among cardiovascular diseases, coronary artery disease (CAD) is on top. Coronary angiography (CAG) is the most preferred method in the diagnosis and treatment of coronary artery diseases. Coronary angiography is the procedure of taking images from the cardiac veins by administering radiopaque materials through the radial, brachial or femoral arteries. Since the procedure and intervention area in coronary angiography affect the patient’s hospitalization duration and ability to meet their needs such as activity and eating, the patient’s comfort may be negatively affected.

[0007] In the present art, an access route called an arterial sheath is inserted by entering through the femoral, radial or brachial arteries under local anesthesia, which is commonly performed. Catheters are advanced through this sheath with a guide wire to reach the ascending aorta and heart. A special x-ray device is used to guide the physician. After the catheter is inserted into the coronary arteries, the radiopaque material is introduced into the artery. The radiopaque material allows better visualization of the coronary arteries. Images can also be taken to obtain information about the function of the heart valves and cardiac contraction. The procedure usually takes 15-45 minutes. After the procedure is completed, if the intervention area is radial, pressure is applied to this area with a radial compression device while the vascular cannula called sheath is removed. The compression device stops the bleeding by applying pressure to the artery, it is removed after 2-5 hours and a mini bandage is applied. At the end of the procedure, 10-15 mL of air is injected into the reservoir of the compression device and when the patient’s systolic blood pressure is above 20 mmHg or after the visual observation that the bleeding has stopped, 2 mL of additional air is injected and the treated area is compressed by applying pressure. This pressure is monitored for bleeding by removing 1 mL of air after 30 minutes and 2 mL after 60 minutes, or by reducing the pressure by 30 mmHg per hour. After it is observed that there is no bleeding with 8 mL or less air, the band is completely removed within 2-5 hours in total and the area is cleaned. If bleeding is observed while the pressure is reduced by removing the air, the pressure is increased by injecting air again and waited and the pressure is reduced again after 30 minutes.

[0008] One of the most common complications after radial artery interventions is radial artery occlusion. The reasons for this include damage to the radial artery endothelium during the procedure and application of occlusive compression during post-procedural compression. Hemostasis with compression of the radial artery without occlusion is an independent predictor of radial artery patency. In addition, although ulnar artery patency is tested with the Modified Allen test before the procedure, radial artery occlusion that may occur during and after the procedure due to endothelial damage and thrombus risk during the procedure may result in hand ischemia, pain, paresthesia or loss of hand motor functions in patients with insufficient collateral circulation.

[0009] Although radial and femoral artery routes have been specifically used for coronary angiography, radial artery entry has become increasingly common. In interventions with radial artery entry, positive aspects such as decreased complications related to the entry site, early mobilization, avoiding the need for long hospitalization, cost and patient comfort are among the reasons for preference. Radial artery entry significantly reduces bleeding complications and increases patient comfort. For angiography via the radial route, with the use of appropriate materials and increasing experience, the success rates are similar to those of the femoral route, while the procedure time is shorter and complication rates are reduced. It has been shown that the procedure cost and intervention area complication rate are higher and hospitalization duration is longer in patients with femoral route stent implantation. Monitoring hemostasis after radial artery intervention requires frequent monitoring of the patient. However, health care professionals themselves monitor this process. In this case, bleeding can occur, ranging from mild bleeding to subcutaneous hematomas. These situations constitute a risk for patient health and comfort. Applying compression for too long and with too much pressure is associated with pain, paresthesia and an increased rate of radial artery occlusion. After angiography, the health care professional responsible for the monitoring of each patient after the procedure records the time of initiation of radial artery compression, then monitors the presence of bleeding by reducing the pressure every hour for 5 hours, and removes the compression device completely when the time is over. However, due to the increase in the number of patients and the limited number of health care professionals, this is too important to be left to the individual monitoring of health care professionals during the intervention to the patient.

[0010] The radial artery compression devices used in the present art require monitoring by health care professionals and cause subjective action. In services with a high volume of patients, they may cause compression to be applied for longer than necessary, increasing the risk of complications.

[0011] A search of the state of the art revealed the application numbered CN208404728U and titled “A KIND OF RADIAL ARTERY COMPRESSION HEMOSTAT WITH PRESSURE MONITORING FUNCTION”. Said application discloses a medical instrument comprising ontology for a radial artery hemostat by compression of a pressure sensing function. The said ontology is equipped with an air inflation and deflation control device to compress the radial artery. The air inflation and deflation control device comprises: a main control center, an inflation module that applies the inflation / deflation process to the airbag; a pressure detection module and a timing module that allows recording up to the pressing time for puncturing the air intake part of the airbag. Said application has the advantages of automatic monitoring pressure, and the hemostatic effect on compression is good. However, the device described in said application only provides pressure application and the type and duration of the pressure is monitored remotely. Here, by applying a certain mm Hg pressure and warning when the time is up, the patient cannot be easily monitored by health care professionals. In addition, monitoring of oxygenation with an oximeter and providing patient-specific pressure is not possible. A search of the state of the art revealed another application numbered CN209253006U and titled “Radial Artery Compressor Timed to Automatically Reduce Bleeding After Coronary Angiography”. Said application relates to a timing-type radial artery compressor that can automatically reduce pressure and alarm for bleeding after coronary angiography. Herein, the sliding sleeve is arranged in the shell, the sliding sleeve is sleeved with a limiting sleeve; cotton pads are arranged on the lower parts of the sliding sleeves; a positive power connector and a negative power connector are arranged on the side; a lower compression bolt is arranged on the cotton pad; the lower compression bolt is connected to the upper compression bolt by means of a spring; a limiting groove is formed on the side face of the sliding sleeve and mated with a limiting column, the limiting column slides in an air gap, the air gap is connected to an electromagnetic switch valve, the electromagnetic switch valve is connected to a controller, a timer, an air pump and a controller are connected to a negative power connector, the air pump and a buzzer, and the internal threads are arranged at the top of the shell and match the external threads of the limiting bolt body. The corresponding strap grips are arranged at the top of the shell and secure the belt body, the clasps are arranged at the end of the belt body and the length of the external threads is larger than that of the internal threads. The utility model describes automatic decompression, automatic control of bleeding alarm, convenient operation, reducing manual work, guaranteeing safety. However, the aim here is to provide compression only by applying pressure, and there is no individual-specific pressure application, monitoring, informing the main center when the time is over, and monitoring of oxygenation.

[0012] As a result, improvements are being made in the systems provided for the control of bleeding after angiography, therefore, there is a need for new embodiments that will eliminate the disadvantages mentioned above and bring solutions to the existing systems.

[0013] OBJECT OF THE INVENTION

[0014] The present invention relates to a device for the control of bleeding after angiography, which meets the requirements mentioned above, eliminates all disadvantages and brings some additional advantages. The main object of the invention is to provide a control and notification system for monitoring hemostasis after coronary angiography (CAG), which allows minimizing complications by informing health care personnel with an audible warning at the times when bleeding control should be performed.

[0015] An object of the invention is to ensure that the patient’s compression pressure after coronary angiography (CAG) is set correctly from the beginning, to ensure that the radial artery is not occluded during compression, to recognize hand ischemia early and to reduce the occlusion rate by completing compression as soon as possible.

[0016] An object of the invention is to protect the patient from the risks of bleeding or hematoma at the intervention area, and radial artery occlusion due to prolonged compression by informing health care professionals with an audible warning at the times when bleeding control should be performed to monitor hemostasis after coronary angiography (CAG) during the busy work schedule of health care personnel.

[0017] The structural and characteristic features and all advantages of the invention will be more apparent from the following figures and the detailed description with reference to these figures. Therefore, the interpretation should be based on these figures and the detailed description.

[0018] BRIEF DESCRIPTION OF THE FIGURES

[0019] In order to best understand the embodiment of the present invention and its advantages together with the additional elements, it should be interpreted in conjunction with the figures described below.

[0020] Fig. 1 is a representative view of the system for the control of bleeding after coronary angiography according to the invention.

[0021] Fig. 2 is another representative view of the system for the control of bleeding after coronary angiography according to the invention.

[0022] REFERENCE NUMBERS 1. Oximeter

[0023] 2. Warning indicator

[0024] 3. Wrist sleeve

[0025] 4. Display

[0026] 5. Mute button

[0027] 6. Buzzer

[0028] 7. Battery

[0029] 8. Air motor

[0030] 9. Micro-controller

[0031] DETAILED DESCRIPTION OF THE INVENTION

[0032] In this detailed description, the preferred embodiments of the system according to the invention are described solely for the purpose of a better understanding of the subject and without any limiting effect.

[0033] The invention, representative views of which are shown in Figs. 1 and 2, is a control and notification system for monitoring hemostasis after coronary angiography (CAG), which allows minimizing complications by informing health care personnel with an audible warning at the times when bleeding control should be performed. The system according to the invention comprises:

[0034] • An oximeter (1) worn on the patient’s finger that instantaneously measures the oxygen value in the blood,

[0035] • A wrist sleeve (3) worn on the patient’s wrist that delivers predetermined amounts of pressure to the patient to detect whether there is bleeding,

[0036] • An air motor (8) that generates the pressure sent to the patient through the wrist sleeve (3),

[0037] • A micro-controller (9) that analyzes the values coming from the oximeter (1 ) and delivered to the wrist sleeve (3), determines whether these values deviate from the predetermined values as a result of the analysis, and generates a command to warn the health care personnel in case that a deviation is detected,

[0038] • A warning indicator (2), which, upon command from the micro-controller (9), provides a visual warning instantaneously when there is a deviation in the values coming from the oximeter (1 ) and delivered to the wrist sleeve (3); and to ensure that the personnel attend to the patient when the time set by the health care personnel is over,

[0039] • A buzzer (6), which, upon command from the micro-controller (9), provides an audible warning instantaneously when there is a deviation in the values coming from the oximeter (1) and delivered to the wrist sleeve (3); and to ensure that the personnel attend to the patient when the time set by the health care personnel is over,

[0040] • A mute button (5) which, when pressed, mutes the warnings coming from the warning indicator (2) and buzzer (6),

[0041] • An LCD display (4) showing the patient’s health values and the system’s running time,

[0042] • A battery (7) to power the system.

[0043] With the system according to the invention, the pressure generated at the desired level by an air motor (8) is sent to a wrist sleeve (3) worn on the patient’s wrist to provide post-intervention bleeding control of the patient who has undergone coronary angiography (CAG). The pressure sent to the wrist sleeve (3) can be adjusted in the desired time and amount. An oximeter (1) is worn on the patient’s finger to measure the oxygen value in the blood. The information coming from the oximeter (1) and the wrist sleeve (3) is continuously controlled by a micro-controller (9). When the microcontroller (9) detects a deviation in the values read from the oximeter (1) and wrist sleeve (3) outside the required values, a warning indicator (2) lights up and a buzzer (6) emits an audible warning, instantaneously warning the health care personnel about the patient’s condition. An LCD display (4) shows warnings about the patient’s condition, thereby allowing the health care personnel to monitor the patient’s condition by looking at the display (4) and monitor the running time and warnings instantaneously. For example, when hours 1 and 2 of the running time are over, the patient from whom the warning has been received is shown on display (4) to the health care personnel. The warning indicator (2) and buzzer (2) provide a warning when there is a deviation in the patient’s instantaneous health values, as well as a warning to the health care personnel to check the patient when the predetermined time intervals for bleeding control (e.g. every hour) have passed. The warnings coming from the warning indicator (2) and buzzer (2) can only be stopped by the mute button (5). An exemplary embodiment of the invention is described below. When the procedure is over after coronary angiography (CAG), the control system according to the invention is applied to the intervention area after the sheath is removed and the counter is started. The system is also connected to an oximeter (1) placed on the patient’s thumb. The pressure is set 20 mmHg above the systolic blood pressure and delivered to the patient with a wrist sleeve (3). If it is observed that the patient is not bleeding at this pressure value, the pressure value is increased to determine whether there is bleeding in the form of leakage. At this stage, manual pressure is applied on the ulnar artery and when the oxygen value on the oximeter (1 ) falls below 94% or when the waveform is seen to disappear with the plethysmography function of the oximeter (1), the pressure is reduced and the pressure value is adjusted at the first pressure at which the waveform is restored. After 60 minutes, the first phase ends and health care professionals are informed via the warning indicator (2) and buzzer (2) before the system reduces the pressure by 30 mmHg. The health care professional approaches the respective wrist sleeve (3) and checks for bleeding and if there is no bleeding, the pressure is reduced by 30 mmHg and adjusted to the new pressure level. The timer is switched on again and after 60 minutes the health care professionals are informed again via the warning indicator (2) and buzzer (2). The warning continues until the health care professional approaches the respective wrist sleeve (3) and presses the mute button (5). The health care professional checks for bleeding and adjusts the pressure to the new level by reducing it by 30 mmHg again. Lastly, the health care professionals are warned via the warning indicator (2) and buzzer (2) to remove the wrist sleeve (3) after 2-5 hours. At any time during this cycle, when the oxygen value on the oximeter (1) falls below 94% or when the waveform is seen to disappear with the plethysmography function of the oximeter (1 ), health care professionals are warned instantaneously via the warning indicator (2) and buzzer (2).

Claims

CLAIMS1 . A system for monitoring whether the patient is bleeding after coronary angiography, which reduces post-procedure complications by warning health care personnel when bleeding is detected instantaneously and at the times when bleeding control should be performed, characterized in that it comprises:• An oximeter (1) worn on the patient’s finger that instantaneously measures the oxygen value in the blood,• A wrist sleeve (3) worn on the patient’s wrist that delivers predetermined amounts of pressure to the patient to detect whether there is bleeding,• An air motor (8) that generates the pressure sent to the patient through the wrist sleeve (3),• A micro-controller (9) that analyzes the oxygen values coming from the oximeter (1 ) and the pressure values delivered to the wrist sleeve (3), determines whether these values exceed the predetermined values as a result of the analysis, and generates a command to warn the health care personnel in case it detects that they exceed,• A warning indicator (2), which, upon command from the micro-controller (9), provides a visual warning instantaneously when there is a deviation in the values of the oximeter (1 ) and wrist sleeve (3); and to ensure that the personnel attend to the patient when the time set by the health care personnel is over,• A mute button (5) which, when pressed, stops the warnings coming from the warning indicator (2),• An LCD display (4) showing the patient’s health values and the system’s running time,• A battery (7) to power the system.

2. A system according to claim 1 , characterized in that it comprises a buzzer (6), which, upon command from the micro-controller (9), provides an audible warning instantaneously when there is a deviation in the values of the oximeter (1 ) and wrist sleeve (3); and to ensure that the personnel attend to the patient when the time set by the health care personnel is over and a mute button (5) which, when pressed, stops the warnings coming from the buzzer (6).

Images