阅读说明：本技术 冠状静脉窦压力调节系统 (Coronary sinus pressure regulating system ) 是由 王建 何奔 于 2021-09-13 设计创作，主要内容包括：本发明公开了冠状静脉窦压力调节系统,包括置于体内的压力测定调节装置和体外的压力控制装置,压力测定调节装置包括固定球囊和限流球囊,限流球囊连接于固定球囊的内侧,固定球囊的前后两端均固定连接有压力测定导丝,压力控制装置包括压力调节管,本发明所达到的有益效果包括：本发明专利采用内、外双球囊的设计能够有效减少装置释放时对冠状静脉窦的损伤,降低手术并发症的发生,本发明专利在采用可调节限流孔的设计,能够在植入后即刻对冠状静脉窦血流产生限流作用,根据固定球囊两端测定的压力阶差,根据冠状静脉窦的血流量实时调节通过孔径,使冠状静脉窦的回流压力保持在一定的范围。(The invention discloses a coronary sinus pressure regulating system, which comprises a pressure measuring and regulating device arranged in a body and a pressure control device arranged in the body, wherein the pressure measuring and regulating device comprises a fixed saccule and a current-limiting saccule, the current-limiting saccule is connected to the inner side of the fixed saccule, the front end and the rear end of the fixed saccule are both fixedly connected with pressure measuring guide wires, the pressure control device comprises a pressure regulating tube, and the coronary sinus pressure regulating system has the following beneficial effects that: the invention adopts the design of the inner balloon and the outer balloon, which can effectively reduce the damage to the coronary sinus when the device is released and reduce the occurrence of operation complications.)

1. Coronary sinus pressure governing system, its characterized in that, including internal pressure measurement adjusting device (1) and external pressure control device (2) of arranging in, pressure measurement adjusting device (1) is including fixed sacculus (11) and current-limiting sacculus (12), current-limiting sacculus (12) are connected in the inboard of fixed sacculus (11), the equal fixedly connected with pressure measurement seal wire (15) in both ends around fixed sacculus (11), pressure control device (2) are including pressure adjustment pipe (22), set up the pressure regulation interface in current-limiting sacculus (12), pressure adjustment pipe (22) fixed connection is in the pressure regulation interface of current-limiting sacculus (12).

2. The coronary sinus pressure regulation system of claim 1, wherein: the middle part of the flow limiting sacculus (12) is provided with a flow limiting hole (13) which transversely penetrates through the flow limiting sacculus, the middle part of the fixed sacculus (11) is provided with a blood flow channel (14), and the blood flow channel (14) is communicated with the flow limiting hole (13).

3. The coronary sinus pressure regulation system of claim 1, wherein: pressure sensor (21) are installed to the tip that pressure measurement seal wire (15) are located external part, pressure sensor (21) and external central controller electric connection, pressure regulation pipe (22) are located external one end and are connected with the force pump.

4. The coronary sinus pressure regulation system of claim 1, wherein: the fixed sacculus (11) is internally provided with an outer connecting pipe interface and is internally connected with a fixed sacculus outer connecting pipe (3), and the fixed sacculus outer connecting pipe (3) is positioned at one external end of the pressure pump fixedly connected with.

5. The coronary sinus pressure regulation system of claim 1, wherein: a low compliance layer (4) is arranged between the fixed saccule (11) and the current limiting saccule (12), and the inner side of the fixed saccule (11) is fixedly connected with the outer wall of the current limiting saccule (12) through the low compliance layer (4).

The technical field is as follows:

the invention belongs to the technical field of equipment for improving myocardial ischemia through a coronary sinus, and particularly relates to a coronary sinus pressure regulating system.

Background art:

with the aging population and the prevalence of risk factors for ischemic heart diseases such as hypertension and diabetes, cardiologists have focused on restoring severely narrowed or blocked coronary arteries to increase the blood perfusion of the heart to improve the clinical symptoms and prognosis of patients with myocardial ischemia. However, the therapeutic quest to improve myocardial perfusion through retrograde coronary venous perfusion has been elusive. At present, the coronary sinus is intermittently blocked by a balloon at foreign countries, and the myocardial tissue of an ischemic region is reversely perfused by increasing the pressure of the coronary sinus. By improving the pressure of coronary sinus, the myocardial perfusion of patients with refractory angina can be remarkably relieved, the myocardial infarction area of patients with acute myocardial infarction is reduced, and the clinical symptoms and prognosis of the patients are improved.

In the prior art, the coronary sinus is intermittently blocked in a balloon expansion mode, and the coronary sinus of a patient has different flow rates, so that the pressure rise degree and time are different, and pericardial effusion or myocardial internal hemorrhage caused by coronary sinus damage can be possibly caused; furthermore, the lack of continuous monitoring of pressure within the coronary sinus does not provide a standardized standard of treatment for the patient.

The invention content is as follows:

the present invention is directed to solving the above problems by providing a coronary sinus pressure regulating system that overcomes the disadvantages of using a balloon dilation version to intermittently occlude the coronary sinus: 1. because the coronary sinus of the patient has different flow, the degree and time of pressure rise are different, and pericardial effusion or myocardial internal hemorrhage caused by coronary sinus damage can occur; 2. the lack of continuous monitoring of pressure within the coronary sinus does not provide a standardized standard of treatment for the patient.

In order to solve the above problems, the present invention provides a technical solution:

coronary sinus pressure governing system, including internal pressure measurement adjusting device and the external pressure control device of arranging in, pressure measurement adjusting device is including fixed sacculus and current-limiting sacculus, the current-limiting sacculus is connected in the inboard of fixed sacculus, the equal fixedly connected with pressure measurement seal wire in both ends around the fixed sacculus, pressure control device includes the pressure regulating tube, set up the pressure regulation interface in the current-limiting sacculus, pressure regulating tube fixed connection is in the pressure regulation interface of current-limiting sacculus, and fixed sacculus is fixed in coronary sinus with the system, according to the pressure that head end pressure measurement seal wire was surveyed, adjusts the internal diameter of current-limiting sacculus through the pressure regulating tube, makes the blood of heart self backward flow right atrium through adjustable aperture inflow, keeps the blood pressure before the pressure regulation system at certain scope through external pressure control device, the blood flow of the heart is redistributed, and the retrograde blood flow perfusion in the ischemic area is increased.

Preferably, the current-limiting sacculus middle part is seted up the current-limiting hole that transversely runs through, the blood runner has been seted up at the middle part of fixed sacculus, the blood runner is linked together with the current-limiting hole, and blood accessible blood runner gets into the current-limiting hole circulation, and pressure controller control force pump aerifys to the pressure regulating tube and bleeds and can make the internal diameter of current-limiting hole change.

Preferably, pressure sensor is installed to the tip that the pressure measurement seal wire is located external part, pressure sensor and external central controller electric connection, the pressure regulating tube is located external one end and is connected with the force pump, and pressure sensor detects pressure, and pressure signal transmits to central controller, and central controller control force pump is aerifyd the air suction to the pressure regulating tube and can be makeed the internal diameter change of spacing sacculus to adjust the pressure in the current-limiting sacculus.

Preferably, it has the outer union coupling of fixed sacculus to have seted up outer union coupling interface and outer union coupling interface in-connection in the fixed sacculus, fixed sacculus outer union coupling is located external one end fixedly connected with force pump, uses force pump to connect fixed sacculus outer union coupling, and it is fixed in coronary sinus opening part to prop up to inflate fixed sacculus, can make fixed sacculus outer union coupling fix more firm at coronary sinus opening part.

Preferably, a low compliance layer is arranged between the fixed balloon and the current limiting balloon, and the inner side of the fixed balloon and the outer wall of the current limiting balloon are fixedly connected through the low compliance layer, so that the fixed balloon and the current limiting balloon are connected more stably.

The beneficial effects of the invention include:

1. the invention adopts the design of the inner balloon and the outer balloon, which can effectively reduce the damage to the coronary sinus when the device is released and reduce the occurrence of operation complications (coronary sinus interlayer or perforation).

2. The invention adopts the design of the adjustable flow limiting hole, can generate the flow limiting effect on the blood flow of the coronary sinus immediately after being implanted, and can adjust the passing aperture in real time according to the blood flow of the coronary sinus according to the pressure step difference measured at the two ends of the fixed saccule, so that the reflux pressure of the coronary sinus is kept in a certain range, and the reverse perfusion that the myocardial hemorrhage or the pressure is too small to increase the ischemic area caused by the overlarge pressure of the coronary sinus is avoided.

3. The invention adopts the design of coronary sinus pressure negative feedback to adjust the inner diameter of the current limiting saccule, and can realize the dynamic adjustment of heart blood under different physiological states according to the individual heart function state. When the total perfusion of the heart is increased, the amount of the return blood which needs to pass through the coronary sinus is increased, and the pressure in the coronary sinus is higher than a set threshold value, the pressure of the flow-limiting saccule is reduced through the external pressure control device, the inner diameter of the flow-limiting saccule is enlarged, and the pressure in the coronary sinus is reduced; and the total perfusion of the heart is reduced, the amount of the return blood needed to pass through the coronary sinus is reduced, and when the pressure in the coronary sinus is lower than a set threshold value, the pressure of the flow-limiting saccule is increased through the external pressure control device, the inner diameter of the flow-limiting saccule is reduced, and the pressure of the coronary sinus is increased.

Description of the drawings:

for ease of illustration, the invention is described in detail by the following detailed description and the accompanying drawings.

FIG. 1 is a schematic sectional view of the present invention;

FIG. 2 is a schematic perspective view of the present invention;

fig. 3 is a schematic side view of the connection between the fixed balloon and the flow limiting balloon of the present invention.

In the figure: 1. a pressure measurement adjusting device; 11. fixing the balloon; 12. a flow-limiting balloon; 13. a flow restriction orifice; 14. a blood flow channel; 15. a pressure measurement guidewire; 2. a pressure control device; 21. a pressure sensor; 22. a pressure regulating tube; 3. fixing a balloon external connecting pipe; 4. a low compliance layer.

The specific implementation mode is as follows:

in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without one or more of these specific details. In other instances, well-known features have not been described in order to avoid obscuring the invention.

Example 1

The coronary sinus pressure regulating system shown in fig. 1-2 comprises a pressure measuring and regulating device 1 arranged in a body and a pressure control device 2 arranged outside the body, wherein the pressure measuring and regulating device 1 comprises a fixed saccule 11 and a current limiting saccule 12, the current limiting saccule 12 is connected to the inner side of the fixed saccule 11, pressure measuring guide wires 15 are fixedly connected to the front end and the rear end of the fixed saccule 11, the pressure control device 2 comprises a pressure regulating tube 22, a pressure regulating interface is arranged in the current limiting saccule 12, and the pressure regulating tube 22 is fixedly connected to the pressure regulating interface of the current limiting saccule 12.

In the prior art, the coronary sinus is intermittently blocked in a balloon expansion mode, and the coronary sinus of a patient has different flow rates, so that the pressure rise degree and time are different, and pericardial effusion or myocardial internal hemorrhage caused by coronary sinus damage can be possibly caused; furthermore, the lack of continuous monitoring of the pressure within the coronary sinus does not provide a standardized treatment for the patient. The invention provides a system which can be safely and temporarily placed in a human coronary sinus and can reversely improve myocardial blood flow perfusion by dynamically adjusting the pressure in the coronary sinus.

In the embodiment, the coronary sinus pressure measuring and adjusting device 1 is sent to a proper position and released by a minimally invasive intervention method, the system is fixed to the coronary sinus by the fixing balloon 11, the pressure measured by the head end pressure measuring guide wire 15 is used, the inner diameter of the flow limiting balloon 12 is adjusted by the pressure adjusting tube 22, the blood flowing back from the heart per se flows into the right atrium through an adjustable aperture, the blood pressure in front of the pressure adjusting system is kept in a certain range by the extracorporeal pressure control device 2, the traffic branch of the heart is fully opened, the blood flow of the heart is redistributed, and the retrograde blood flow perfusion of an ischemic region is increased;

in the preferred embodiment, after local anesthesia, the right internal jugular vein is punctured and the venous sheath is placed, the guiding guide wire is sent into the right atrium to the coronary sinus through the venous sheath, the coronary sinus pressure regulating system with a proper size is selected, the device is sent to a proper position along the guiding guide wire, the fixed balloon 3 is connected with the fixed balloon external connecting pipe by using the pressure pump, the fixed balloon 11 is inflated and supported and fixed at the opening of the coronary sinus, the pressure detected by the pressure sensor 21 on the guide wire 15 is detected according to the head end pressure, the pressure signal is transmitted to the central controller, the pressure controller controls the pressure pump to inflate and exhaust the pressure regulating pipe 22, so that the inner diameter of the flow limiting balloon 12 is changed, the aperture of the flow limiting hole 13 is adjusted, the blood flowing back of the heart per se flows into the right atrium through the adjustable aperture, the diameter of the flow limiting balloon 12 is adjusted by the external pressure control system, when the pressure sensor 21 of the pressure measuring guide wire 15 at the front end measures that the pressure of the coronary sinus is lower than a set value, the pressure in the flow limiting saccule 12 is increased by an in vitro pressure control system through the pressure adjusting tube 22, so that the inner diameter of the flow limiting saccule is reduced, and according to Bernoulli's theorem, the pressure in front of the flow limiting saccule 12 is increased; when the pressure of the coronary sinus measured by the pressure measuring guide wire 15 at the front end is higher than a set value, the internal diameter of the coronary sinus is increased by reducing the pressure in the current-limiting saccule 12 by the external pressure control system, and similarly, the pressure in front of the current-limiting saccule 12 is reduced, so that the pressure in the coronary sinus can be kept to be increased to a certain range, the traffic branch of the heart is fully opened, the blood flow of the heart is redistributed, and the retrograde blood perfusion in an ischemic region is increased.

Example 2

Referring to fig. 1, a further improvement is made on the basis of embodiment 1:

in order to ensure the circulation of blood, a restriction hole 13 which transversely penetrates is formed in the middle of the flow limiting saccule 12, a blood flow channel 14 is formed in the middle of the fixed saccule 11, and the blood flow channel 14 is communicated with the restriction hole 13;

in this embodiment, blood can flow through the blood flow channel 14 and into the restriction orifice 13, and the pressure controller controls the pressure pump to pump air into the pressure regulating tube 22 to cause the inner diameter of the restriction orifice 13 to change.

In order to accurately detect the pressure, the end part of the pressure measurement guide wire 15, which is positioned outside the body, is provided with a pressure sensor 21, the central controller outside the body is electrically connected with the pressure sensor 21, and one end of the pressure adjusting pipe 22, which is positioned outside the body, is connected with a pressure pump.

In this embodiment, the pressure sensor 21 detects the pressure, and the pressure signal is transmitted to the central controller, which controls the pressure pump to inflate and deflate the pressure regulating tube 22, so as to change the inner diameter of the flow restriction balloon 12, thereby regulating the pressure inside the flow restriction balloon 12.

Example 3

Referring to fig. 1 and fig. 3, a further improvement is made on the basis of embodiment 1:

in order to enable the fixed saccule 11 to be connected more stably, an external connecting pipe interface is arranged in the fixed saccule 11, the external connecting pipe 3 of the fixed saccule is connected in the external connecting pipe interface, and one end of the external connecting pipe 3 of the fixed saccule, which is positioned outside the body, is fixedly connected with a pressure pump;

in this embodiment, use the force pump to connect fixed sacculus external union pipe 3, will fix sacculus 11 and inflate the gas and prop up and be fixed in coronary sinus opening part, can make fixed sacculus external union pipe 3 fixed more firm at coronary sinus opening part.

In order to better connect the fixed balloon 11 and the current limiting balloon 12, the low compliance layer 4 is arranged between the fixed balloon 11 and the current limiting balloon 12, and the inner side of the fixed balloon 11 is fixedly connected with the outer wall of the current limiting balloon 12 through the low compliance layer 4, so that the connection between the fixed balloon 11 and the current limiting balloon 12 is more stable.

While there have been shown and described what are at present considered to be the fundamental principles of the invention and its essential features and advantages, it will be understood by those skilled in the art that the invention is not limited by the embodiments described above, which are merely illustrative of the principles of the invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the invention as defined by the appended claims and their equivalents.