A balloon catheter pressure automatic control system and method

Abstract

The present invention discloses a balloon catheter pressure automatic control system and method, which relates to the technical field of medical devices. The system comprises: a balloon, a catheter, a pressure detection module, a control module, a filling module and a pressure relief module; the pressure detection module is used to obtain the pressure data of the balloon in real time; the control module is used to control the filling module or the pressure relief module to adjust the pressure of the balloon in real time according to the pressure data of the balloon; the filling module is used to increase the pressure of the balloon according to the pressure increase control signal of the control module, and the pressure relief module is used to reduce the pressure of the balloon according to the pressure reduction control signal of the control module. The present invention realizes the automatic regulation of the pressure of the balloon catheter.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a balloon catheter pressure automatic control system and method. Background Art

[0002] A balloon catheter is a soft catheter with an inflatable balloon at its tip, which is used to enlarge narrow openings or passages in the body during catheterization. In application, a deflated balloon catheter is placed, then inflated to perform the necessary procedures, and then deflated again for removal. It is commonly used to balloon dilate narrow blood vessels, including peripheral blood vessels and coronary arteries. The dilation effect of the balloon can also be used to treat stenosis of some other organs, such as sinuses, tear ducts, salivary ducts, esophagus, bile duct, urethral strictures, etc. The balloon can also be used to compress and stop bleeding, such as postpartum bleeding, intrauterine bleeding, bile duct, urethra, gastric fundus, and lower esophageal bleeding. In addition, balloon technology is widely used in obstetrics and gynecology, such as cervical dilation balloon catheters and balloon uterine stents.

[0003] The balloon catheter currently used in clinical practice generally adopts the method of pushing gas or liquid into the balloon by a syringe to expand the balloon to a certain volume or reach a certain pressure value. It is often used to expand narrow openings or channels in the body, such as dilating narrow blood vessels, or using the balloon for compression hemostasis. However, to grasp the balloon inflation pressure, doctors need to comprehensively judge whether the current balloon state has reached the ideal state based on various information (such as CT, X-ray, blood vessel wall thickness, etc.). In compression hemostasis, insufficient balloon pressure cannot provide a good hemostasis effect. Excessive balloon pressure will completely compress the blood vessel wall and cause ischemia of the lower end blood vessel. In order to avoid ischemia of the lower end blood vessel, medical staff need to frequently adjust the balloon pressure according to the actual situation, not only to ensure hemostasis, but also to ensure the slight flow of blood in the lower end blood vessel, which has a large workload. At the same time, during the treatment process, if the balloon pressure is not accurately controlled, it will also cause local hematoma, retroperitoneal bleeding, and the risk of pseudoaneurysm and amputation in the local compression of the femoral artery. Summary of the invention

[0004] The purpose of the present invention is to provide a balloon catheter pressure automatic control system and method, which realizes the automatic regulation of the balloon catheter pressure.

[0005] To achieve the above object, the present invention provides the following solutions:

[0006] A balloon catheter pressure automatic control system, comprising: a balloon, a catheter, a pressure detection module, a control module, a filling module and a pressure relief module;

[0007] The pressure detection module is used to obtain the pressure data of the balloon in real time;

[0008] The control module is used to control the filling module or the pressure relief module in real time to adjust the pressure of the balloon according to the pressure data of the balloon;

[0009] The filling module is used to increase the pressure of the balloon according to the pressure increase control signal of the control module, and the pressure relief module is used to reduce the pressure of the balloon according to the pressure reduction control signal of the control module.

[0010] Optionally, the pressure detection module includes 6 pressure sensors, and the 6 pressure sensors are respectively a first pressure sensor, a second pressure sensor, a third pressure sensor, a fourth pressure sensor, a fifth pressure sensor and a sixth pressure sensor;

[0011] The six pressure sensors are symmetrically distributed on the outer surface of the balloon with the cross-section where the catheter in the balloon is located as the separator. The first pressure sensor, the third pressure sensor and the fifth pressure sensor are distributed on one side of the cross-section, and the second pressure sensor, the fourth pressure sensor and the sixth pressure sensor are distributed on the other side of the cross-section.

[0012] Optionally, the first pressure sensor is located between the third pressure sensor and the fifth pressure sensor, and the second pressure sensor is located between the fourth pressure sensor and the sixth pressure sensor;

[0013] When the balloon is located inside the blood vessel, the first pressure signal obtained by the first pressure sensor is the pressure signal on one side of the blood vessel, the second pressure signal obtained by the second pressure sensor is the pressure signal on the other side of the blood vessel, the third pressure signal obtained by the third pressure sensor and the fourth pressure signal obtained by the fourth pressure sensor are both distal balloon wall blood pressure signals, and the fifth pressure signal obtained by the fifth pressure sensor and the sixth pressure signal obtained by the sixth pressure sensor are both proximal balloon wall blood pressure signals.

[0014] Optionally, the six pressure sensors are all flexible film pressure sensors.

[0015] Optionally, each of the pressure sensors is bonded to the balloon surface via a two-component epoxy resin glue, and each of the pressure sensors is connected to the control module via an electrical wire, and the electrical wire is bonded to the corresponding balloon surface and the corresponding catheter outer wall via conductive glue.

[0016] Optionally, the control module is used to:

[0017] performing filtering processing on the third pressure signal, the fourth pressure signal, the fifth pressure signal and the sixth pressure signal;

[0018] Calculate the average pressure value of the third pressure signal after filtering to obtain the third average blood pressure; calculate the average pressure value of the fourth pressure signal after filtering to obtain the fourth average blood pressure; calculate the average pressure value of the fifth pressure signal after filtering to obtain the fifth average blood pressure; calculate the average pressure value of the sixth pressure signal after filtering to obtain the sixth average blood pressure;

[0019] Obtaining a first average blood pressure difference between the proximal end and the distal end of the balloon according to the fifth average blood pressure and the third average blood pressure;

[0020] Obtaining a second average blood pressure difference between the proximal end and the distal end of the balloon according to the sixth average blood pressure and the fourth average blood pressure;

[0021] taking the average of the first average blood pressure difference and the second average blood pressure difference as the average blood pressure difference;

[0022] If the average blood pressure difference is less than the lower threshold, and both the first pressure signal and the second pressure signal are less than a first preset pressure value, then outputting an increase control signal;

[0023] If the average blood pressure difference is greater than the upper limit threshold, and both the first pressure signal and the second pressure signal are greater than a second preset pressure value, a pressure reduction control signal is output.

[0024] Optionally, the filling module is used to inject gas or liquid into the balloon according to an increase control signal, and the pressure relief module is used to extract gas or liquid from the balloon according to a decompression control signal.

[0025] The present invention also discloses a method for automatically regulating the pressure of a balloon catheter, comprising:

[0026] The pressure detection module obtains the pressure data of the outer surface of the bladder in real time;

[0027] The control module controls the filling module or the pressure relief module in real time to adjust the pressure of the balloon according to the pressure data of the balloon.

[0028] According to the specific embodiments provided by the present invention, the present invention discloses the following technical effects:

[0029] The present invention obtains pressure data of the outer surface of the balloon in real time, and controls the filling module or the pressure relief module to adjust the pressure of the balloon in real time according to the pressure data of the balloon, thereby realizing automatic adjustment of the pressure of the balloon catheter, reducing the workload of medical personnel, reducing the influence of human factors and improving the accuracy of pressure control. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0031] Figure 1 A schematic diagram of the structure of a balloon catheter pressure automatic control system provided by an embodiment of the present invention;

[0032] Figure 2 A schematic diagram of the distribution of pressure sensors and electrical wires on the balloon provided by an embodiment of the present invention;

[0033] Figure 3 A schematic diagram of the distribution of pressure sensors on the balloon provided in an embodiment of the present invention.

[0034] Explanation of symbols:

[0035] 1-balloon, 2-catheter, 3-blood vessel wall, 4-electrical wire, s1-first pressure sensor, s2-second pressure sensor, s3-third pressure sensor, s4-fourth pressure sensor, s5-fifth pressure sensor, s6-sixth pressure sensor. DETAILED DESCRIPTION

[0036] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] The purpose of the present invention is to provide a balloon catheter pressure automatic control system and method, which realizes the automatic regulation of the balloon catheter pressure.

[0038] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0039] Example 1

[0040] like Figure 1 As shown, this embodiment provides a balloon catheter pressure automatic control system, which includes: a balloon 1, a catheter 2, a pressure detection module, a control module, a filling module and a pressure relief module.

[0041] The pressure detection module is used to obtain the pressure data of the balloon 1 in real time.

[0042] The control module is used to control the filling module or the pressure relief module in real time to adjust the pressure of the balloon 1 according to the pressure data of the balloon 1 .

[0043] The filling module is used to increase the pressure of the balloon 1 according to the pressure increase control signal of the control module, and the pressure relief module is used to reduce the pressure of the balloon 1 according to the pressure reduction control signal of the control module.

[0044] The pressure detection module includes six pressure sensors, which are a first pressure sensor s1, a second pressure sensor s2, a third pressure sensor s3, a fourth pressure sensor s4, a fifth pressure sensor s5 and a sixth pressure sensor s6.

[0045] The pressure detection module and the control module are connected by an electrical conductor 4. The control module obtains the real-time value of each pressure sensor in the pressure detection module in real time, and determines the current pressure state of the balloon 1 according to the built-in algorithm to achieve pressurization and depressurization of the balloon and the catheter.

[0046] The control module can send a control signal to control the filling module (gas / liquid to filling module) and the pressure relief module. When the pressure value needs to be increased, the control module sends a control signal to the gas / liquid filling module, and the gas / liquid filling module continues to inject gas / liquid, and the pressure value in the balloon and catheter gradually increases; when the pressure value needs to be reduced, the control module sends a control signal to the pressure relief module, and the pressure relief module releases the current pressure value, and the pressure in the balloon and catheter gradually decreases.

[0047] The six pressure sensors are symmetrically distributed on the outer surface of the balloon 1 with the cross section where the catheter in the balloon is located as the separator. The first pressure sensor s1, the third pressure sensor s3 and the fifth pressure sensor s5 are distributed on one side of the cross section, and the second pressure sensor s2, the fourth pressure sensor s4 and the sixth pressure sensor s6 are distributed on the other side of the cross section.

[0048] The first pressure sensor s1 is located between the third pressure sensor s3 and the fifth pressure sensor s5 , and the second pressure sensor s2 is located between the fourth pressure sensor s4 and the sixth pressure sensor s6 .

[0049] When the balloon is located inside the blood vessel, the first pressure signal obtained by the first pressure sensor s1 is the pressure signal on one side of the blood vessel, the second pressure signal obtained by the second pressure sensor s2 is the pressure signal on the other side of the blood vessel, the third pressure signal obtained by the third pressure sensor s3 and the fourth pressure signal obtained by the fourth pressure sensor s4 are both blood pressure signals of the distal end balloon 1 wall, the fifth pressure signal obtained by the fifth pressure sensor s5 and the sixth pressure signal obtained by the sixth pressure sensor s6 are both blood pressure signals of the proximal end balloon 1 wall.

[0050] The first pressure signal and the second pressure signal are pressure signals between the balloon 1 and the upper blood vessel wall 3 and the lower blood vessel wall 3 respectively.

[0051] All six pressure sensors are flexible thin film pressure sensors.

[0052] Each of the pressure sensors is bonded to the surface of the balloon 1 by a two-component epoxy resin glue, and each of the pressure sensors is connected to the control module by an electrical conductor 4, and the electrical conductor 4 is bonded to the corresponding surface of the balloon 1 or the corresponding outer wall of the catheter 2 by a conductive glue, and the electrical conductor 4 corresponding to the outer wall of the catheter 2 is bonded to the outer wall of the catheter 2 as a whole, and finally connected to the control module, such as Figure 2 shown.

[0053] In terms of controlling the filling module or the pressure relief module to adjust the pressure of the balloon in real time according to the pressure data of the balloon, the control module is used to:

[0054] The third pressure signal, the fourth pressure signal, the fifth pressure signal and the sixth pressure signal are filtered.

[0055] The filtering process is specifically as follows: using wavelet analysis to select the signal frequency band of the blood pressure signal, removing the baseline and high-frequency signal (ie, removing the noise), and obtaining a low-frequency blood pressure signal.

[0056] Calculate the average pressure value of the third pressure signal after filtering to obtain the third average blood pressure; calculate the average pressure value of the fourth pressure signal after filtering to obtain the fourth average blood pressure; calculate the average pressure value of the fifth pressure signal after filtering to obtain the fifth average blood pressure; calculate the average pressure value of the sixth pressure signal after filtering to obtain the sixth average blood pressure.

[0057] A first average blood pressure difference P1 between the proximal end and the distal end of the balloon is obtained according to the fifth average blood pressure and the third average blood pressure.

[0058] A second average blood pressure difference P2 between the proximal end and the distal end of the balloon is obtained according to the sixth average blood pressure and the fourth average blood pressure.

[0059] The average of the first average blood pressure difference and the second average blood pressure difference is taken as the average blood pressure difference P. P=(P1+P2) / 2.

[0060] If the average blood pressure difference is within a specified threshold range (the average blood pressure difference is greater than or equal to a lower threshold and less than or equal to an upper threshold), the balloon maintains the current pressure.

[0061] If the average blood pressure difference is less than the lower threshold, and both the first pressure signal and the second pressure signal are less than a first preset pressure value, an increase control signal is output.

[0062] The average blood pressure difference is less than the lower limit threshold, which indicates that the blood pressure at the proximal and distal ends of the balloon is basically the same, the blood flow dynamics at the distal end of the balloon is stronger, and the hemostatic effect cannot be achieved at the distal end. At the same time, the control module combines the first pressure signal and the second pressure signal to make a judgment. The pressure values ​​of the first pressure signal and the second pressure signal are small. At this time, the balloon pressure needs to be increased.

[0063] If the average blood pressure difference is greater than the upper limit threshold, and both the first pressure signal and the second pressure signal are greater than a second preset pressure value, a pressure reduction control signal is output.

[0064] The average blood pressure difference is greater than the upper limit threshold, indicating that there is a large difference in blood pressure between the proximal and distal ends of the balloon, and the blood flow dynamics at the distal end of the balloon is weak. Combined with the first pressure signal and the second pressure signal, it is judged that the pressure values ​​of the first pressure signal and the second pressure signal are large, and the blood vessel wall is in a state of compression. If it continues for a long time, it will cause complications such as congestion, local hematoma, and blood vessel rupture, and the balloon pressure needs to be reduced.

[0065] The control module sends a control signal to the corresponding module according to the above judgment result. If the balloon pressure needs to be increased, a control signal is sent to the gas / liquid filling module, and the gas / liquid filling module starts and continues to inject gas / liquid into the balloon to increase the balloon pressure; if the balloon pressure needs to be reduced, a control signal is sent to the pressure relief module, and the pressure relief module controls the opening and closing of the pressure relief port to reduce the balloon pressure.

[0066] The filling module is used to inject a predetermined amount of gas or a predetermined amount of liquid into the balloon according to an increase control signal, and the pressure relief module is used to extract a predetermined amount of gas or a predetermined amount of liquid from the balloon according to a decompression control signal.

[0067] After the pressure is adjusted, the control module continues to monitor the pressure value sent by the pressure detection module and performs calculations and analysis to adjust the balloon pressure so that the balloon pressure is maintained in a stable range.

[0068] The present invention uses a multi-dimensional pressure sensing device combined with a control algorithm to automatically control the pressure in the balloon catheter according to the patient's physiological characteristics and treatment needs, ensuring that the balloon can achieve the best treatment effect, shorten the treatment time and reduce the risk of treatment failure. At the same time, the system can also avoid excessive or low balloon pressure caused by human factors or improper operation, reduce complications and adverse reactions during treatment, and improve the safety of treatment, and has broad application prospects.

[0069] Example 2

[0070] This embodiment provides a method for automatically controlling pressure of a balloon catheter, the method comprising:

[0071] Step 101: The pressure detection module obtains pressure data of the outer surface of the bladder in real time;

[0072] Step 102: The control module controls the filling module or the pressure relief module in real time to adjust the pressure of the balloon according to the pressure data of the balloon.

[0073] In this specification, each embodiment is described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the embodiments can be referred to each other. For the method disclosed in the embodiment, since it corresponds to the system disclosed in the embodiment, the description is relatively simple, and the relevant parts can be referred to the system part description.

[0074] The principles and implementation methods of the present invention are described in this article using specific examples. The description of the above embodiments is only used to help understand the method and core idea of ​​the present invention. At the same time, for those skilled in the art, according to the idea of ​​the present invention, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A balloon catheter pressure automatic control system, characterized in that: include: Balloon, catheter, pressure detection module, control module, filling module and pressure relief module; The pressure detection module is used to obtain the pressure data of the balloon in real time; The control module is used to control the filling module or the pressure relief module in real time to adjust the pressure of the balloon according to the pressure data of the balloon; The filling module is used to increase the pressure of the balloon according to the pressure increase control signal of the control module, and the pressure relief module is used to reduce the pressure of the balloon according to the pressure reduction control signal of the control module; The pressure detection module includes 6 pressure sensors, which are respectively a first pressure sensor, a second pressure sensor, a third pressure sensor, a fourth pressure sensor, a fifth pressure sensor and a sixth pressure sensor; Six pressure sensors are symmetrically distributed on the outer surface of the balloon with the cross section where the catheter in the balloon is located as a partition, the first pressure sensor, the third pressure sensor and the fifth pressure sensor are distributed on one side of the cross section, and the second pressure sensor, the fourth pressure sensor and the sixth pressure sensor are distributed on the other side of the cross section; The first pressure sensor is located between the third pressure sensor and the fifth pressure sensor, and the second pressure sensor is located between the fourth pressure sensor and the sixth pressure sensor; When the balloon is located inside a blood vessel, the first pressure signal obtained by the first pressure sensor is a pressure signal on one side of the blood vessel, the second pressure signal obtained by the second pressure sensor is a pressure signal on the other side of the blood vessel, the third pressure signal obtained by the third pressure sensor and the fourth pressure signal obtained by the fourth pressure sensor are both distal end balloon wall blood pressure signals, the fifth pressure signal obtained by the fifth pressure sensor and the sixth pressure signal obtained by the sixth pressure sensor are both proximal end balloon wall blood pressure signals; All six pressure sensors are flexible film pressure sensors; The control module is used for: performing filtering processing on the third pressure signal, the fourth pressure signal, the fifth pressure signal and the sixth pressure signal; Calculating an average pressure value of the third pressure signal after filtering to obtain a third average blood pressure; Calculating an average pressure value of the fourth pressure signal after filtering to obtain a fourth average blood pressure; Calculating an average pressure value of the fifth pressure signal after filtering to obtain a fifth average blood pressure; Calculating an average pressure value of the sixth pressure signal after filtering to obtain a sixth average blood pressure; Obtaining a first average blood pressure difference between the proximal end and the distal end of the balloon according to the fifth average blood pressure and the third average blood pressure; Obtaining a second average blood pressure difference between the proximal end and the distal end of the balloon according to the sixth average blood pressure and the fourth average blood pressure; taking the average of the first average blood pressure difference and the second average blood pressure difference as the average blood pressure difference; If the average blood pressure difference is less than the lower threshold, and both the first pressure signal and the second pressure signal are less than a first preset pressure value, then outputting an increase control signal; If the average blood pressure difference is greater than the upper limit threshold, and both the first pressure signal and the second pressure signal are greater than a second preset pressure value, a pressure reduction control signal is output.

2. The balloon catheter pressure automatic control system according to claim 1, characterized in that: Each of the pressure sensors is bonded to the balloon surface by two-component epoxy resin glue, and each of the pressure sensors is connected to the control module by an electrical wire, and the electrical wire is bonded to the corresponding balloon surface and the corresponding catheter outer wall by conductive glue.

3. The balloon catheter pressure automatic control system according to claim 1, characterized in that: The filling module is used to inject gas or liquid into the balloon according to an increase control signal, and the pressure relief module is used to extract gas or liquid from the balloon according to a decompression control signal.

4. A method for automatically controlling the pressure of a balloon catheter, characterized in that: The balloon catheter pressure automatic control method uses the balloon catheter pressure automatic control system according to claim 1, and the balloon catheter pressure automatic control method comprises: The pressure detection module obtains the pressure data of the outer surface of the bladder in real time; The control module controls the filling module or the pressure relief module in real time to adjust the pressure of the balloon according to the pressure data of the balloon.

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