CN112294278B - Intravascular pressure measuring catheter - Google Patents

Abstract

The present disclosure provides an intravascular pressure measurement catheter comprising: a distal cannula having a guidewire lumen slidably receiving a separate medical guidewire; a proximal portion coupled to the distal cannula; a pressure sensor disposed within and separating the lumen of the proximal portion from a measurement lumen in communication with the guidewire lumen of the distal cannula, the pressure sensor for measuring blood pressure of blood flowing into the measurement lumen and generating a blood pressure signal, and the proximal portion further comprising a signal path for transmitting the blood pressure signal from the pressure sensor. The intravascular pressure measuring catheter provided by the disclosure can reduce the thickness of the distal sleeve and avoid forming a bulge, so that the distal sleeve can pass through a narrower lesion, the application range is widened, and the pushability of the pressure catheter in a blood vessel is also increased.

Description

intravascular pressure measuring catheter

Technical field

The present invention relates to an intravascular pressure measuring catheter.

Background technique

Fractional coronary flow reserve (FFR: Fractional Flow Reserve) refers to the maximum blood flow that can be obtained in the myocardial area supplied by the blood vessel when there is a stenotic lesion in the coronary artery and the maximum blood flow that can be obtained in the same area under normal circumstances. The flow ratio has now become an invasive functional evaluation index, which has important guiding significance for the treatment strategy of coronary heart disease. In medicine, FFR is widely used to accurately diagnose functional myocardial ischemia in coronary heart disease, helping doctors determine whether there is a stenotic lesion and whether cardiac stent implantation (PCI: Percutaneous Coronary Intervention) is needed. At the same time, it can also be used to evaluate the efficacy after stent implantation. The FFR can accurately reflect the functional severity of stenosis, help doctors more objectively select indications for interventional treatment, guide optimal stent implantation, and determine the therapeutic effect and long-term effects. period effect. For example, when the FFR is less than 0.7 to 0.8, stent implantation or coronary artery bypass surgery should be considered for critical coronary artery disease. Therefore, the judgment of FFR can help doctors make accurate judgments and avoid over-treatment due to doctors' misjudgments.

Currently, most pressure-sensing catheters with a Rapid Exchange (RX) port are used. The distal part has an inner lumen for passing a guidewire. By fitting the distal part onto the guidewire, the catheter can be inserted along the guidewire. The guidewire moves the pressure sensing catheter to a predetermined location. Before coronary intervention, the pressure-sensing catheter was passed through the distal side and proximal (right) side of the stenosis, and distal blood pressure and proximal blood pressure were recorded respectively. From this, the narrow FFR value can be calculated.

However, the placement of the pressure sensor often results in a bulge in the local part of the pressure sensing catheter (where the pressure sensor is located). When the pressure sensing catheter moves along the guide wire within the blood vessel, it may be difficult to pass through some of the more serious conditions. The pressure at the narrow part cannot be measured. Moreover, when the pressure sensing catheter passes through the stenotic lesion, the pressure sensor may come into contact with the stenotic lesion. Therefore, it will affect the measurement of the pressure sensor, and the accurate FFR value cannot be obtained, and the doctor cannot provide accurate information. basis for judgment.

Contents of the invention

In view of the above technical problems existing in the prior art, the present disclosure provides an intravascular pressure measurement catheter capable of measuring pressure on stenotic blood vessels, an intravascular pressure measurement method, and an intravascular pressure detection device.

The present disclosure relates to an intravascular pressure measurement catheter that includes: a distal cannula having a guidewire lumen slidably receiving a separate medical guidewire; a proximal portion coupled to the distal cannula; a pressure sensor, which is disposed in the lumen of the proximal part and separates the lumen of the proximal part from a measurement cavity, and the measurement cavity is connected to the guide of the distal cannula The wire lumen is connected, the pressure sensor is used to measure the blood pressure of the blood flow flowing into the measurement chamber and generate a blood pressure signal, and the proximal part further includes a pressure sensor for transmitting the blood pressure signal from the pressure sensor. signal path.

The intravascular pressure measuring catheter provided by the present disclosure can reduce the thickness of the distal casing and avoid the formation of bulges. Therefore, the distal casing can pass through narrower lesions, broaden the scope of application, and also increases the pressure measuring catheter. Pushability in blood vessels. In addition, the pressure sensor is protected by the wall of the proximal part, which can reduce the impact on the pressure sensor when the pressure measurement catheter is bumped or bent, and can improve the accuracy of blood pressure measurement.

In addition, in the intravascular pressure measurement catheter related to the present disclosure, optionally, the pressure sensor includes a sensing portion and a lead portion, the sensing portion has a sensing area for sensing pressure, and the lead portion is formed by The blood pressure signal generated by the sensing area is derived. Thus, the medical staff can connect the lead part to the external device through the signal path and then read the measured blood pressure information through the external device.

In addition, in the intravascular pressure measurement catheter related to the present disclosure, optionally, a quick exchange port for receiving the medical guidewire is provided on the side wall of the distal sleeve. In this case, the guide wire can guide the pressure measuring catheter through the quick exchange port, whereby the intravascular pressure measuring catheter can slide along the guide wire, thereby positioning the hose to a specific location in the patient's body. Improve the surgical efficiency of interventional treatment.

In addition, in the intravascular pressure measurement catheter related to the present disclosure, optionally, at least the Young's modulus of the proximal end portion provided with the pressure sensor is greater than the Young's modulus of the distal cannula. In this case, the proximal part can better protect the pressure sensor and reduce the impact of the intravascular pressure measurement catheter on the pressure sensor due to deformation, thereby ensuring the measurement accuracy of the pressure sensing device.

In addition, in the intravascular pressure measurement catheter related to the present disclosure, optionally, the pressure sensor is a membrane pressure sensor and forms an angle with the length direction of the proximal end portion. This allows the membrane pressure sensor to measure blood pressure at an appropriate angle.

In addition, in the intravascular pressure measurement catheter related to the present disclosure, optionally, it further includes an intermediate portion connecting the distal sleeve and the proximal portion, and the Young's modulus of the intermediate portion is between between the Young's modulus of the distal cannula and the Young's modulus of the proximal portion. Thus, the robustness of the intravascular pressure measurement catheter in the blood vessel can be increased, making it easier for doctors to operate.

In addition, the intravascular pressure measurement catheter according to the present disclosure optionally further includes an outer tube covering the distal sleeve and the proximal portion. Therefore, before the pressure measurement catheter enters the coronary artery, the impact of the collision between the intravascular pressure measurement catheter and the blood vessel wall on the stability of the measurement catheter can be reduced.

In addition, in the intravascular pressure measurement catheter related to the present disclosure, optionally, the included angle is 45° to 135°. As a result, it can better contact the blood flow and measure blood pressure more accurately.

In addition, in the intravascular pressure measurement catheter related to the present disclosure, optionally, the guidewire lumen slidably receives a medical guidewire having an outer diameter of approximately 0.2 mm to 1 mm. Thus, the types of guide wires that can be received can be increased.

In addition, in the intravascular pressure measurement catheter related to the present disclosure, optionally, the distal sleeve and the proximal portion are coaxial. This can improve the stability of the intravascular pressure measurement catheter.

According to the intravascular pressure measuring catheter of the present invention, it is possible to provide an intravascular pressure measuring catheter capable of measuring pressure in a stenotic blood vessel, an intravascular pressure measuring method, and an intravascular pressure detection device.

Description of the drawings

FIG. 1 is a schematic cross-sectional view showing an intravascular pressure measuring catheter according to an embodiment of the present invention.

FIG. 2 is a schematic partial cross-sectional view showing an intravascular pressure measuring catheter according to the embodiment of the present invention.

3 is a schematic partial cross-sectional view showing an intravascular pressure measurement catheter according to another embodiment of the present invention.

4 is a schematic diagram showing the combination of the pressure sensor and the base of the intravascular pressure measurement catheter according to the embodiment of the present invention.

5 is a schematic diagram showing the lead portion of the pressure sensor of the intravascular pressure measurement catheter according to the embodiment of the present invention.

Explanation of drawing symbols:

1…intravascular pressure measuring catheter, 2…medical guide wire, 10…distal cannula, 20…proximal part, 30…pressure sensor, 40…pedestal, 11…annular cannula, 12…outer tube, F… Blood flow inflow direction, θ...the angle between the pressure sensor and the horizontal plane, 31...sensing part, 32...lead part, 32a, 32b, 32c...pins.

Detailed ways

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings. In the following description, the same components are assigned the same reference numerals, and repeated descriptions are omitted. In addition, the drawings are only schematic diagrams, and the dimensional ratios of components or the shapes of components may be different from actual ones.

FIG. 1 is a schematic cross-sectional view showing an intravascular pressure measurement catheter 1 according to an embodiment of the present invention.

As shown in FIG. 1 , an intravascular pressure measurement catheter 1 (hereinafter, sometimes also referred to as "pressure measurement catheter 1", "blood pressure measurement catheter 1", "measurement catheter 1") includes a distal sleeve 10 with a slidable The guidewire lumen that receives an independent medical guidewire 2 (hereinafter, sometimes also referred to as "guidewire 2", "guidewire 2"); the proximal portion 20, which is connected with the distal cannula 10; a pressure sensor 30, which is arranged in the lumen of the proximal part 20 and separates the lumen of the proximal part 20 from the measurement cavity. The measurement cavity is connected with the guidewire lumen of the distal cannula 10. The pressure sensor 30 is used for The blood pressure of the blood flow into the measurement chamber is measured and a blood pressure signal is generated, and the proximal portion 20 further includes a signal path for transmitting the blood pressure signal from the pressure sensor 30 .

The intravascular pressure measurement catheter 1 provided by the present disclosure can reduce the thickness of the distal cannula 10 so that it does not have a bulge. Therefore, the distal cannula 10 can pass through narrower lesions, broaden the scope of application, and also The pushability of the pressure measuring catheter 1 in the blood vessel is increased, making it easier for doctors to operate and saving operation time. In addition, the pressure sensor 30 is protected by the proximal wall of the tube, which can reduce the impact on the pressure sensor when the pressure measurement catheter 1 is bumped or bent, thereby improving the accuracy of blood pressure measurement.

In the blood pressure measurement catheter 1 according to this embodiment, the distal sleeve 10 has a guidewire lumen. The guidewire lumen slidably receives an individual medical guidewire 2 . Therefore, by allowing the distal cannula 10 to receive and slide along the medical guidewire 2, the distal cannula 10 and the pressure sensor 30 provided on the proximal portion 20 can be sent to a predetermined location in the patient's body (eg, vein, artery). Location. Thus, blood pressure can be measured at the predetermined location (such as a lesion location) to obtain a reading of the fractional flow reserve (FFR) of the location, which provides a reference for subsequent interventional treatments.

As mentioned above, the value of fractional flow reserve (FFR) (referred to as "FFR value") can be used to evaluate the extent to which stenotic lesions block blood flow through blood vessels, and provide doctors and others with decisions on whether to carry out interventional treatment. Generally speaking, in order to calculate the FFR value for a given stenosis, blood pressure readings need to be measured and collected separately on the distal side of the stenosis (eg, downstream of the stenosis) and the proximal side of the stenosis (eg, upstream of the stenosis, close to the aorta). The blood pressure gradient across a stenotic lesion reflects an indication of stenosis severity. The more severe the stenosis, the greater the pressure drop and the lower the FFR value.

In some examples, the guidewire lumen slidably receives a medical guidewire 2 having an outer diameter of approximately 0.2 mm to 1 mm. Thus, the types of guide wires 2 that can be received can be increased.

In some examples, a quick exchange port for receiving the medical guidewire 2 is provided on the side wall of the distal cannula 10 . In this case, the guide wire 2 can guide the pressure measuring catheter 1 through the quick exchange port, whereby the intravascular pressure measuring catheter 1 can slide along the guide wire 2 to position the hose into the patient's body. specific position to improve the surgical efficiency of interventional treatment.

In some examples, at least the proximal portion 20 disposed with the pressure sensor 30 has a Young's modulus greater than the Young's modulus of the distal cannula 10 . In this case, the proximal portion 20 can better protect the pressure sensor 30 and reduce the intravascular pressure measurement catheter 1 from squeezing the pressure sensor 30 due to deformation, thereby ensuring the measurement accuracy of the pressure sensing device.

In some examples, a middle portion connecting the distal cannula 10 and the proximal portion 20 is also included, the middle portion having a Young's modulus between the Young's modulus of the distal cannula 10 and the Young's modulus of the proximal portion 20 . between quantities. Thus, the robustness of the intravascular pressure measuring catheter 1 in the blood vessel can be increased, making it easier for doctors to operate.

In some examples, the material constituting the proximal part 20 is not particularly limited, and materials with higher hardness are preferably used to ensure that the doctor can move the distal cannula 10 along the medical guidewire 2 through the proximal part 20 during interventional treatment. It is advanced into the patient's blood vessel and then located at the stenotic lesion.

In some examples, proximal portion 20 may be stiffer and more rigid than distal cannula 10 to enable better movement and advancement of distal cannula 10. In some examples, proximal portion 20 may be constructed from medical grade stainless steel. In other examples, the proximal portion 20 may also be made of other materials such as nitinol, nylon, plastic, polyimide (PI), etc.

In some examples, the pressure sensor 30 includes a sensing portion 31 having a sensing area for sensing pressure, and a lead portion 32 that passes a blood pressure signal generated by the sensing area through pins (32a, 32b, 32c) Export. Thus, the medical staff can connect the lead part to the external device through the signal path and then read the measured blood pressure information through the external device.

In some examples, the signal path may be connected to a device external to the patient, such as a processor, display, computer, monitor, or other medical device.

In some examples, an outer tube 12 covering the distal cannula 10 and the proximal portion 20 is also provided. Therefore, before the pressure measurement catheter 1 enters the coronary artery, the impact of the collision between the intravascular pressure measurement catheter 1 and the blood vessel wall on the stability of the measurement catheter 1 can be reduced.

In addition, in some examples, an annular sleeve 11 as a positioning mark may also be provided at the front end of the distal sleeve 10 . The annular sleeve 11 is flexible and contains an X-ray opaque material. In other examples, the annular sleeve 11 may be flexible. Therefore, when the blood pressure measurement catheter 1 moves within the patient's blood vessel, damage to the blood vessel can be reduced.

In this embodiment, as mentioned above, during interventional treatment, it is necessary to move the distal cannula 10 by operating the proximal part 20 (specifically, connecting the blood pressure measurement catheter 1). When the distal cannula 10 is moved or adjusted within the blood vessel along the medical guidewire 2, the distal cannula 10 may touch the blood vessels near the distal cannula 10 or parts of the blood vessels with large curvature. In this case, even if the distal cannula 10 slides along the medical guidewire 2 and touches a nearby blood vessel, since the annular cannula 11 provided at the front end of the distal cannula 10 has flexibility, Can reduce damage to blood vessels.

In addition, in this embodiment, since the annular sleeve 11 contains a material that is opaque to X-rays, when the human body is irradiated by X-rays, the annular sleeve 11 can form an opaque pattern. Through this opaque pattern, doctors and others can quickly find the corresponding positioning mark.

In some examples, the outer peripheral surface of the outer tube 12 is preferably tangent to the annular cannula 11 , thereby improving the operability of the distal cannula 10 and the annular cannula 11 . The material of the outer tube 12 may be polyester, polyamide, nylon, nylon elastomer, polyurethane, polyimide (PI), etc.

In other examples, outer tube 12 may be part of the distal cannula 10 forming process. For example, the outer tube 12 and the distal sleeve 10 are tightly connected by using welding. In addition, the guidewire lumen of the distal cannula 10 can be formed by heat melt molding.

FIG. 2 is a schematic partial cross-sectional view showing the intravascular pressure measuring catheter 1 according to the embodiment of the present invention. FIG. 3 is a partial cross-sectional schematic diagram showing an intravascular pressure measuring catheter 1 according to another embodiment of the present invention. FIG. 4 is a schematic diagram showing the coupling of the pressure sensor 30 and the base 40 of the intravascular pressure measurement catheter 1 according to the embodiment of the present invention. FIG. 5 is a schematic diagram showing the lead portion 32 of the pressure sensor 30 of the intravascular pressure measurement catheter 1 according to the embodiment of the present invention.

In some examples, pressure sensor 30 is disposed at proximal portion 20 . Blood flows through the distal cannula 10 into the proximal portion 20 and comes into contact with the pressure sensor 30, which (more specifically, the measurement site of the pressure sensor 30) is capable of sensing and/or measuring the patient's intravascular blood pressure, and generate blood pressure signals. The pressure sensor 30 is connected to a signal path, and the blood pressure signal generated by the pressure sensor 30 is transmitted to, for example, an external processing device (not shown) via the signal path.

In some examples, the pressure sensor 30 may be a membrane pressure sensor and form an angle θ with the length direction of the proximal portion 20 . This allows the membrane pressure sensor 30 to measure the blood pressure at an appropriate angle.

In some examples, the angle θ ranges from 45° to 135°. As a result, it can better contact the blood flow and measure blood pressure more accurately.

As shown in FIG. 2 , blood flows in the direction indicated by the arrow, and the pressure sensor 30 can measure the pressure of the blood flow flowing in the F direction. In other examples, the pressure sensor 30 may form an included angle θ with the horizontal plane L1 in the L2 direction, and the included angle θ may be between 45° and 135°.

As shown in FIG. 3 , in other examples, the pressure sensor 30 may be disposed at a position tangential to the quick exchange port. In this case, blood can flow out from the quick exchange port along the pressure sensor 30 , reducing the impact of blood backflow on blood pressure measurement, thereby improving blood pressure measurement accuracy.

Additionally, in some examples, pressure sensor 30 may be a capacitive pressure sensor, a resistive pressure sensor, or the like. In addition, the pressure sensor 30 may also be a MEMS pressure sensor. For example, the pressure sensor 30 has a measurement range of about -50 mm Hg to about +300 mm Hg. Depending on the type of pressure sensor 30, the signal path may be a conductive medium such as an electrical wire. In addition, in some embodiments, the signal path may also be a wireless communication line, an infrared communication line or an ultrasonic communication line.

As shown in Figures 4 and 5, in some examples, the proximal portion 20 can also be provided with a base 40 for supporting the pressure sensor 30. The lead portion 32 of the pressure sensor 30 is combined with the base 40, and the sensing portion 31 is used to Measure blood flow pressure. In some examples, the base 40 may be an alloy made of one or more materials among cobalt-chromium alloy, titanium alloy, aluminum alloy or stainless steel, or a composite material of any of the above alloys. In addition, it can also be made of hard engineering plastics such as ABS, PMMA, PET, etc., which has sufficient flexural strength and can effectively suppress the stress deformation of the stent.

In other examples, the base 40 may be fixed in the lumen of the proximal part 20 by welding, fitting, bonding, or the like.

In addition, in some examples, the base 40 can be configured correspondingly according to the shape of the proximal portion 20 so that the pressure sensor 30 can measure the pressure of the blood in the blood vessel without any impact, more accurately measure the blood pressure value, and provide the doctor with accurate information. data results.

In some examples, the base 40 may not be used to fix the pressure sensor 30 , and the pressure sensor 30 may be directly disposed within the lumen of the proximal portion 20 . Therefore, the pressure sensor 30 can directly receive the pressure of the blood in the blood vessel without being affected by the base 40 .

In other examples, gel may be filled between the pressure sensor 30 and the proximal portion 20 . Specifically, for example, medical silicone gel can be filled, thereby preventing liquids such as blood from penetrating into the lead portion 32 , thereby improving the reliability of the pressure sensor 30 and the signal path that transmits the blood pressure signal. Furthermore, the silicone gel can also provide a cushioning effect for the pressure sensor 30 .

Generally speaking, during interventional treatment, doctors and other operators first advance the medical guidewire 2 from a certain part of the patient's body (such as the femoral artery) along the blood vessels to, for example, the coronary arteries of the heart, and then, for example, The contrast agent is used to perform angiography to find the location of the blood vessel where the disease may occur, and then the blood pressure measuring catheter 1 is advanced along the medical guide wire 2 to a predetermined position. In this case, the blood pressure measurement catheter 1 is passed through the distal cannula 10 to the medical guide wire 2 (see the figure), so that the guide wire lumen slides through the medical guide wire 2, and the blood pressure measurement catheter 1 is passed through the medical guide wire 2 through operations (such as pushing and/or or pull) the connected blood pressure measuring catheter 1 (or an operating device (not shown) connected to the connected blood pressure measuring catheter 1 ) outside the patient to move the distal cannula 10 (and the pressure sensor 30 provided on the distal cannula 10 ) until the pressure sensor 30 is at a predetermined position.

In some examples, distal cannula 10 and proximal portion 20 are coaxial. This can improve the stability of the intravascular pressure measuring catheter 1 .

In some examples, since the distal cannula 10 moves along the medical guidewire 2 and is sent to a predetermined position in the patient's blood vessel, there is no need to re-operate the blood pressure measurement catheter 1 involved in the embodiment of the present invention. Positioning the medical guidewire 2.

Specifically, for example, when the pressure sensor 30 on the blood pressure measurement catheter 1 is positioned at the distal end of the stenosis (for example, downstream of the stenosis), the blood pressure on the distal end side of the stenosis is first measured. Then, without adjusting the position of the medical guidewire 2, the pressure sensor 30 can reach the proximal side of the stenosis by moving (eg, advancing and/or retracting) the distal cannula 10, thereby allowing the pressure sensor 30 to reach the proximal side of the stenosis without moving the medical guidewire 2. With guidewire 2, take blood pressure readings distal to the stenosis and proximal to the stenosis. As a result, the surgical complexity of interventional treatment can be reduced and the surgical time can be saved.

Although the present invention has been specifically described above in conjunction with the drawings and embodiments, it can be understood that the above description does not limit the present invention in any form. Those skilled in the art can deform and change the present invention as necessary without departing from the essential spirit and scope of the present invention, and these deformations and changes all fall within the scope of the present invention.

Claims (6)

1. An intravascular pressure measurement catheter, comprising:

a distal cannula having a guidewire lumen slidably receiving a separate medical guidewire, a quick exchange port being provided in a sidewall of the distal cannula for receiving the medical guidewire;

a proximal portion coupled with the distal cannula;

a pressure sensor disposed within the lumen of the proximal portion and separating the lumen of the proximal portion into a measurement cavity in communication with the guidewire lumen of the distal cannula for measuring blood pressure of blood flowing into the measurement cavity via the distal cannula and generating a blood pressure signal, the pressure sensor forming an angle of 45 ° to 135 ° with the length direction of the proximal portion such that the pressure sensor measures blood pressure at a proper angle, an

The proximal portion further comprises a signal path for transmitting the blood pressure signal from the pressure sensor, wherein at least the proximal portion provided with the pressure sensor has a Young's modulus greater than that of the distal sleeve;

the intravascular pressure measurement catheter further includes an intermediate portion connecting the distal cannula and the proximal portion, the intermediate portion having a Young's modulus that is between the Young's modulus of the distal cannula and the Young's modulus of the proximal portion.

2. The intravascular pressure measurement catheter of claim 1 wherein,

the pressure sensor includes a sensing portion having a sensing region that senses pressure, and a lead portion that derives the blood pressure signal generated by the sensing region.

3. The intravascular pressure measurement catheter of claim 1 wherein,

the pressure sensor is a thin film pressure sensor.

4. The intravascular pressure measurement catheter of claim 1 wherein,

an outer tube is also provided that encases the distal sleeve and the proximal portion.

5. The intravascular pressure measurement catheter of claim 1 wherein,

the guidewire lumen slidably receives a medical guidewire having an outer diameter of 0.2mm to 1 mm.

6. The intravascular pressure measurement catheter of claim 1 wherein,

the distal sleeve is coaxial with the proximal portion.