Intravascular pressure measurement catheter with indication of pressure sensor location

Abstract

The present invention provides an intravascular pressure measurement catheter capable of indicating the position of a pressure sensor, comprising: a distal cannula, a developing ring disposed on the distal cannula, and a pressure sensor disposed on the outer circumference of the distal cannula. The developing ring has at least one end formed by beveling an annular tube at an angle to the length of the annular tube and is disposed proximate to the pressure sensor. The pressure sensor measures blood pressure within a blood vessel and generates a blood pressure signal. Under X-ray conditions, the pattern of the developing ring can indicate the radial position of the pressure sensor disposed on the outer circumference of the distal cannula. Medical personnel can use the pattern formed by the beveled portion of the developing ring, disposed on one side of the pressure sensor, to determine the radial position of the pressure sensor under X-ray conditions. This improves the accuracy with which medical personnel can identify the sensing position of the pressure measurement catheter.

Description

[0001] This application is a divisional application of a patent application with an application date of August 7, 2019, application number 201910724191.9, and invention name “Intravascular pressure measuring catheter with developing ring”. Technical Field

[0002] The invention relates to an intravascular pressure measuring catheter capable of indicating the position of a pressure sensor. Background Art

[0003] Percutaneous coronary intervention (PCI) is currently a relatively effective treatment for many cardiovascular diseases, such as coronary artery disease. In recent years, the use of fractional flow reserve (FFR), which assesses the degree to which a stenotic lesion obstructs blood flow through a vessel, has become increasingly popular and widely used to more accurately determine whether a patient truly requires interventional therapy. FFR is defined as the ratio of the maximum blood flow delivered to the myocardium by a stenotic coronary artery to the maximum blood flow available to the myocardium in a normal (non-stenotic) state. When the small vessels in the coronary artery supply are maximally dilated and central venous pressure is not significantly elevated, FFR is approximately equal to the ratio of blood pressure readings distal to the stenosis (e.g., downstream of the stenosis) to those proximal to the stenosis (e.g., upstream of the stenosis, near the aorta). Clinical studies have shown that higher stenosis is associated with lower FFR values. Whether an FFR value is less than an estimated value (e.g., 0.8) can serve as a useful criterion for physicians to decide whether to proceed with interventional therapy in such patients. The effectiveness of this criterion has been confirmed by the results of several large-scale clinical studies in Europe and the United States, such as the FAME clinical study.

[0004] Pressure-sensing catheters with rapid exchange (RX) ports have recently been adopted as a method for measuring intravascular blood pressure. These catheters have a distal lumen that allows for the insertion of a guidewire. By fitting this distal lumen over the guidewire, the catheter can be moved along the guidewire to a predetermined position. Before coronary stent placement, the catheter is passed over the distal and proximal sides of the stenosis, and the distal and proximal blood pressures are recorded, respectively. This allows the calculation of the FFR value of the stenosis.

[0005] For existing pressure-sensing catheters, developing material is usually placed at the distal or proximal end of the catheter to facilitate positioning of the catheter. However, in the prior art, the position of the developing material often does not match the position of the pressure sensor. Therefore, it is difficult for doctors to accurately locate the pressure sensing position based on the position of the developing material during operation. As a result, there is a certain deviation between the recorded distal and proximal blood pressures of the stenosis, which affects the accuracy or precision of the measured FFR value. Summary of the Invention

[0006] The present invention is made in view of the above-mentioned prior art conditions, and its object is to provide an intravascular pressure measuring catheter that is easy to position and can improve the measurement accuracy or precision of the pressure sensing catheter.

[0007] To this end, the present disclosure provides an intravascular pressure measuring catheter with a developing ring, characterized in that it includes: a distal sleeve having a guidewire lumen for slidably receiving a separate medical guidewire; a pressure sensor, which is arranged at the front end of the distal sleeve and is used to measure the blood pressure in the blood vessel and generate a blood pressure signal; a developing ring, which is arranged on a side close to the pressure sensor, and one end of the developing ring is formed by beveling an annular tube along a direction forming an angle with the length direction of the annular tube; and a proximal part, which is connected to the distal sleeve and includes a signal path for transmitting the blood pressure signal from the pressure sensor, and a connecting catheter for supporting the signal path and moving the distal sleeve, wherein, under X-rays, the pattern of the developing ring can indicate the radial position of the pressure sensor arranged on the outer circumference of the distal sleeve.

[0008] In the intravascular pressure measuring catheter involved in the present invention, medical staff can obtain the radial position of the pressure sensor by using the pattern formed by the oblique part of the developing ring provided on one side of the pressure sensor under X-rays, thereby improving the accuracy of medical staff in identifying the sensing position of the pressure measuring catheter.

[0009] The intravascular pressure measurement catheter of the present invention may optionally further include an auxiliary imaging ring, disposed on the other side of the pressure sensor, wherein one end of the auxiliary imaging ring is formed by chamfering the annular tube at an angle relative to the longitudinal direction of the annular tube. In this case, the pressure sensor is positioned between the imaging ring and the auxiliary imaging ring, thereby improving the accuracy of positioning the pressure sensor.

[0010] In addition, in the intravascular pressure measuring catheter of the present invention, optionally, under X-ray, the pattern of the developing ring is gradually tapered toward the sensing position of the pressure sensor, thereby clearly indicating the radial position of the pressure sensor.

[0011] In the intravascular pressure measurement catheter of the present invention, the other end of the developing ring can optionally be formed by beveling the annular tube at an angle relative to the longitudinal direction of the annular tube. In this case, both ends of the developing ring can have beveled surfaces, thereby better indicating the radial position of the pressure sensor.

[0012] In addition, in the intravascular pressure measurement catheter of the present invention, optionally, the radial position is a sensing position of the pressure sensor. Thus, the sensing position can be determined by determining the radial position.

[0013] In the intravascular pressure measuring catheter according to the present invention, the pattern of the developing ring and the pattern of the auxiliary developing ring may be the same, thereby reducing the possibility of misidentification due to unclear patterns.

[0014] In the intravascular pressure measurement catheter according to the present invention, the pressure sensor may optionally be located centrally between the imaging ring and the auxiliary imaging ring, with the pattern on the imaging ring and the pattern on the auxiliary imaging ring both pointing toward the pressure sensor. In this case, the position of the pressure sensor can be further inferred from the positions of the imaging ring and the auxiliary imaging ring, thereby improving the accuracy of identifying the radial position of the pressure sensor.

[0015] In addition, another aspect of the present invention provides an intravascular pressure measuring catheter with a developing ring, which is characterized in that it includes: a distal cannula having a guidewire lumen that can slidably receive a separate medical guidewire; a developing ring that is arranged on the distal cannula, and one end of the developing ring is formed by beveling the annular tube body along a direction forming an angle with the length direction of the annular tube body; a pressure sensor that is arranged on the developing ring and is used to measure the blood pressure in the blood vessel and generate a blood pressure signal; and a proximal part that is connected to the distal cannula and includes a signal path for transmitting the blood pressure signal from the pressure sensor, and a connecting catheter for supporting the signal path and moving the distal cannula, wherein, under X-rays, the pattern of the developing ring indicates the position of the pressure sensor.

[0016] In an intravascular pressure measuring catheter with a developing ring involved in the present invention, medical staff can obtain the radial position of the pressure sensor based on the characteristics of the pressure sensor set on the developing ring and the pattern formed by the oblique part of the developing ring under X-rays to thereby know the specific position of the pressure sensor. This can improve the accuracy of medical staff in identifying the sensing position of the pressure measuring catheter.

[0017] In the intravascular pressure measurement catheter of the present invention, the pressure sensor optionally includes a sensing portion and a lead portion, wherein the sensing portion has a sensing area for sensing pressure, and the lead portion derives a blood pressure signal generated by the sensing area. Thus, blood pressure can be measured using the pressure sensor.

[0018] In addition, in the intravascular pressure measuring catheter of the present invention, the Young's modulus of the imaging ring is optionally greater than that of the distal cannula, thereby reducing the effect of deformation of the pressure measuring catheter on the imaging ring.

[0019] According to the present invention, it is possible to provide an intravascular pressure measuring catheter that facilitates positioning and can improve the measurement accuracy or precision of the pressure sensing catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Embodiments of the present disclosure will now be explained in further detail, by way of example only, with reference to the accompanying drawings, in which:

[0021] Figure 1 It is a schematic perspective view showing the structure of the intravascular pressure measurement catheter with a developing ring according to the first embodiment of the present disclosure.

[0022] Figure 2 It is a schematic side view showing the structure of the intravascular pressure measurement catheter with a developing ring according to the first embodiment of the present disclosure.

[0023] Figure 3 This is a partially enlarged view showing the intravascular pressure measurement catheter with a developing ring according to the first embodiment of the present disclosure.

[0024] Figure 4 1 is a schematic perspective view showing the structure of a developing ring of the intravascular pressure measurement catheter with a developing ring according to the first embodiment of the present disclosure.

[0025] Figure 5 This is a diagram showing the Figure 2 A locally enlarged schematic diagram of area A1.

[0026] Figure 6 It is a schematic perspective structural diagram showing a modified example of the intravascular pressure measurement catheter with a developing ring according to the first embodiment of the present disclosure.

[0027] Figure 7 It shows Figure 6 The schematic diagram of the side structure of the intravascular pressure measurement catheter is shown.

[0028] Figure 8 This is a diagram showing the Figure 7 A locally enlarged schematic diagram of area A2.

[0029] Figure 9 It shows Figure 7 FIG. 1 is a schematic diagram showing the radial position of a pressure sensor disposed on the outer circumference of a distal cannula in an intravascular pressure measurement catheter.

[0030] Figure 10It is a schematic perspective view showing the structure of an intravascular pressure measurement catheter with a developing ring according to a second embodiment of the present disclosure.

[0031] Figure 11 It is a schematic side view showing the structure of an intravascular pressure measurement catheter with a developing ring according to a second embodiment of the present disclosure.

[0032] Figure 12 This is a diagram showing the Figure 11 A partially enlarged schematic diagram of area A3.

[0033] Description of Figure Numbers:

[0034] 1…Intravascular pressure measurement catheter, 10…Distal cannula, 11…Guidewire lumen, 20…Proximal portion, 30…Development ring, 31…Step portion, 40…Pressure sensor, 41…Guide wire, 50…Auxiliary development ring, L1…Length direction, 2…Medical guidewire. DETAILED DESCRIPTION

[0035] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. In the accompanying drawings, identical components or components having identical functions are marked with identical symbols, and repeated descriptions thereof are omitted.

[0036] [First embodiment]

[0037] Figure 1 1 is a schematic perspective view showing the structure of the intravascular pressure measurement catheter 1 with the developing ring 30 according to the first embodiment of the present disclosure. Figure 2 1 is a schematic side view showing the structure of the intravascular pressure measurement catheter 1 with the developing ring 30 according to the first embodiment of the present disclosure.

[0038] The intravascular pressure measuring catheter 1 with a developing ring 30 involved in the present disclosure (sometimes also referred to as "blood pressure measuring catheter 1", "measuring catheter 1", "pressure measuring catheter 1") can include a distal cannula 10, a pressure sensor 40 and a developing ring 30 (refer to Figure 1 and Figure 2 ). The distal sleeve 10 may have a structure that can slidably receive a separate medical guide wire 2 (refer to Figure 3 ) of the guidewire lumen 11. The pressure sensor 40 can be provided at the front end of the distal cannula 10 to measure the blood pressure in the blood vessel and generate a blood pressure signal. The developing ring 30 can be provided on a side close to the pressure sensor 40, and one end of the developing ring 30 is formed by obliquely cutting the annular tube along a direction forming an angle α with the longitudinal direction L1 of the annular tube (refer to Figure 4The proximal portion 20 can be coupled to the distal cannula 10 and includes a signal path for transmitting a blood pressure signal from the pressure sensor 40, and a connecting catheter 1 for supporting the signal path and moving the distal cannula 10. Under X-rays, the pattern of the developing ring 30 can indicate the radial position of the pressure sensor 40 disposed on the outer circumference of the distal cannula 10.

[0039] In the intravascular pressure measuring catheter 1 involved in this embodiment, medical personnel and the like can obtain the radial position of the pressure sensor 40 (described in detail later) by using the pattern formed by the oblique portion of the developing ring 30 provided on one side of the pressure sensor 40 under X-rays, thereby improving the accuracy with which medical personnel can identify the sensing position of the pressure measuring catheter 1.

[0040] In clinical applications, sometimes an abnormality may occur in the signal on the host communicating with the intravascular pressure measuring catheter 1. At this time, the pressure sensor 40 is positioned by the direction (orientation) of the developing ring 30 of the intravascular pressure measuring catheter 1 involved in this embodiment, thereby determining whether the abnormality is caused by the pressure sensor hitting the blood vessel wall.

[0041] In this embodiment, as described above, the distal cannula 10 may have a guidewire lumen 11 that slidably receives a separate medical guidewire 2. In this case, the distal cannula 10 receives the medical guidewire 2 and slides along the medical guidewire 2, thereby enabling the distal cannula 10 and the developing ring 30 and pressure sensor 40 disposed thereon to be pushed to a predetermined location in the patient's body (e.g., a vein or artery).

[0042] In some examples, a groove for accommodating the pressure sensor 40 may be provided on the outer wall of the distal sleeve 10. This can reduce the height of the pressure sensor 40 on the surface of the measuring catheter 1 and reduce the possibility of collision with the inner wall of the blood vessel.

[0043] During an interventional procedure, a blood pressure measuring catheter 1 can be introduced into a patient's body via, for example, the femoral or brachial artery. Specifically, a distal cannula 10 can be threaded with a medical guidewire 2. A physician manipulates the proximal portion 20 of the blood pressure measuring catheter 1, sliding the distal portion along the medical guidewire 2 and advancing it to a predetermined location, such as near a stenosis in a coronary artery. The physician then uses a pressure sensor 40 to measure the blood pressure at the stenosis, including blood pressure readings distal to the stenosis (e.g., downstream of the stenosis, away from the aorta) and proximal to the stenosis (e.g., upstream of the stenosis, closer to the aorta).

[0044] As mentioned above, the value of the fractional flow reserve (FFR) (abbreviated as "FFR value") can be used to assess the extent to which a stenotic lesion blocks blood flow through a blood vessel, providing doctors with a decision on whether to conduct interventional treatment. Generally speaking, in order to calculate the FFR value of a given stenosis, it is necessary to measure and collect blood pressure readings on the distal side of the stenosis (e.g., downstream of the stenosis) and the proximal side of the stenosis (e.g., upstream of the stenosis, close to the aorta). The blood pressure gradient of the stenotic lesion reflects an indication of the severity of the stenosis. The more severe the stenosis, the greater the pressure drop and the lower the FFR value.

[0045] In some examples, there are no particular restrictions on the medical guidewire 2. For example, the medical guidewire 2 may be a guidewire commonly used in interventional surgery. In some examples, the diameter of the medical guidewire 2 is, for example, 0.2 mm to 0.7 mm. Typical or standard medical guidewires 2 have diameters of, for example, 0.36 mm (0.014 inches), 0.40 mm (0.016 inches), 0.64 mm (0.025 inches), and other sizes. Thus, medical guidewires 2 of various specifications can be used in the intravascular pressure measurement catheter 1 of this embodiment. Doctors and the like can easily select medical guidewires 2 of different sizes, especially sizes that meet the doctor's usage habits, thereby facilitating the doctor's operation and use.

[0046] In some examples, the inner diameter of the guidewire lumen 11 of the distal cannula 10 can be slightly larger than the outer diameter of the medical guidewire 2. In this case, doctors and the like can conveniently select medical guidewires 2 of different sizes, as long as the outer diameter of the medical guidewire 2 is smaller than the inner diameter of the guidewire lumen 11. Thus, when using such a medical guidewire 2, on the one hand, it is easier to thread the medical guidewire 2 through the distal cannula 10 and allow the medical guidewire 2 to move or slide relative to the guidewire lumen 11 of the distal cannula 10. On the other hand, it can also prevent the cross-sectional area of ​​the measuring catheter 1 (particularly the cross-sectional area of ​​the distal cannula 10) from increasing.

[0047] In addition, in some examples, in order to allow the medical guide wire 2 to move or slide in the guide wire lumen 11 of the distal cannula 10, the guide wire lumen 11 preferably has a smooth inner surface. This can substantially reduce the resistance during the movement, making it easier for doctors to operate.

[0048] Additionally, in some examples, the guidewire lumen 11 for receiving the medical guidewire 2 may be provided only in the distal cannula 10. That is, the guidewire lumen 11 is limited to the distal cannula 10. In this case, since the guidewire lumen 11 for receiving the medical guidewire 2 is provided only in the distal cannula 10, when the medical guidewire 2 is passed through the guidewire lumen 11, the length of the medical guidewire 2 received by the guidewire lumen 11 is relatively limited, for example, approximately 5 cm to 20 cm. Therefore, the doctor can easily and quickly replace the medical guidewire 2 through the guidewire lumen 11.

[0049] In this embodiment, the shape of the distal cannula 10 is not particularly limited and can be generally in the form of an extended circular tube. However, this embodiment is not limited thereto and the distal cannula 10 of this embodiment can also be in the form of an extended rectangular tube, an elliptical tube, or the like. In some examples, the distal cannula 10 is preferably in the form of an elongated tube for ease of processing and ease of movement within a blood vessel.

[0050] In addition, in this embodiment, the length of the distal cannula 10 is not particularly limited, as long as the distal cannula 10 can conveniently pass the medical guidewire 2 and support the medical guidewire 2 to slide within the guidewire lumen 11 of the distal cannula 10. In some examples, the length of the distal cannula 10 can be, for example, approximately 0.5 cm to 20 cm, preferably 5 cm to 15 cm.

[0051] In addition, in this embodiment, the receiving port of the guidewire lumen 11 can be set at the front end of the distal cannula 10, thereby making it easy to guide the medical guidewire 2 from the receiving port to the distal cannula 10. In addition, the guide port of the guidewire lumen 11 can be set on the side of the measuring catheter 1. In this case, the medical guidewire 2 can slide along the guidewire lumen 11 from the receiving port of the guidewire lumen 11 and be led out from the guide port. As a result, the increase in the cross-sectional area of ​​the distal cannula 10 can be suppressed, thereby suppressing the adverse effect of the cross-sectional area of ​​the distal cannula 10 on the accuracy of blood pressure measurement.

[0052] Figure 3 It is a partially enlarged view showing the intravascular pressure measurement catheter 1 with the developing ring 30 according to the first embodiment of the present disclosure.

[0053] In addition, in this embodiment, the guidewire lumen 11 may include an extension section 111 and a curved section 112 communicating with the extension section 111. In this case, the extension section 111 may include the aforementioned receiving port 11a, and the curved section 112 may include the aforementioned guiding port 11b.

[0054] like Figure 3 As shown, dashed lines L1 and L2 respectively represent the centerlines of the extension section 111 and the curved section 112 of the distal cannula 10. The extension section 111 and the curved section 112 communicate with each other to form a through lumen, thereby receiving the aforementioned separate medical guidewire 2. Specifically, the guidewire lumen 11, including the extension section 111 and the curved section 112, receives the medical guidewire 2, thereby enabling the distal cannula 10 to slide along the medical guidewire 2 to a predetermined location (e.g., a lesion) within the patient's body.

[0055] Furthermore, in this embodiment, the extension section 111 of the guidewire lumen 11 can extend along the length of the distal cannula 10. This ensures that the extension section 111 and the distal cannula 10 move in substantially the same direction. Furthermore, the curved section 112 of the guidewire lumen 11 can be curved. In this case, the increase in the cross-sectional area of ​​the distal cannula 10 can be suppressed, thereby minimizing the adverse effect of the cross-sectional area of ​​the distal cannula 10 on blood pressure measurement accuracy.

[0056] In addition, in this embodiment, the center line L1 of the extension section 111 and the center line L2 of the curved section 112 may form a predetermined angle θ (see Figure 3 From the perspective of suppressing an increase in the cross-sectional area of ​​the distal cannula 10, the predetermined angle θ formed by L1 and L2 is preferably greater than zero and less than 90°. In some examples, the predetermined angle θ formed by L1 and L2 can be, for example, 20° to 60°. Furthermore, from the perspective of facilitating the insertion of the medical guidewire 2, the predetermined angle θ formed by L1 and L2 is preferably 30° to 50°.

[0057] As described above, the medical guide wire 2 can enter the guide wire lumen 11 from the receiving port 11a of the extension section 111, move relatively along the extension section 111, then enter the curved section 112, and finally be led out from the guide port 11b of the curved section 112. In addition, in some examples, the medical guide wire 2 can also enter the guide wire lumen 11 from the guide port 11b of the curved section 112, move relatively or slide relatively within the guide wire lumen 11, and then be extended from the receiving port 11a of the extension section 111.

[0058] Furthermore, in this embodiment, the medical guide wire 2 is constrained by the curved section 112 as it moves relative to the guide wire lumen 11, causing the direction of movement of the medical guide wire 2 to change accordingly. This prevents the medical guide wire 2 (specifically, the end that first enters the guide wire lumen 11) from causing damage to the distal cannula 10 or the proximal portion 20.

[0059] Furthermore, in this embodiment, since the medical guidewire 2 can extend from or enter the side of the distal cannula 10 (specifically, the guide opening 11b of the curved section 112), the distal cannula 10 and the proximal portion 20 can be coaxially coupled, for example. In this case, the increase in the cross-sectional area of ​​the entire intravascular pressure measurement catheter 1 (particularly at the junction of the distal cannula 10 and the proximal portion 20) can be effectively suppressed, thereby facilitating movement of the measurement catheter 1 within the blood vessel and enabling delivery of the measurement catheter 1 to narrower blood vessels.

[0060] In addition, although the guidewire lumen 11 is described above as including the extension 111 and the curved section 112, the present invention is not limited thereto. For example, in some examples, the guidewire lumen 11 may consist solely of the extension 111. In this case, the distal cannula 10 and the proximal portion 20 may not be coupled in a continuous manner, for example, at staggered positions (not shown).

[0061] In some examples, the distal cannula 10 can be preferably made of at least one selected from polyimide (PI), polyester, or nylon. This ensures that the distal cannula 10 can adapt to the shape of a complex and curved blood vessel when passing through it, thereby preventing damage to the blood vessel caused by the distal cannula 10 of the measurement catheter 1.

[0062] (Proximal portion 20)

[0063] In this embodiment, the proximal portion 20 (specifically, one end of the proximal portion 20) is coupled (connected) to the distal cannula 10. Furthermore, the coupling method of the one end of the proximal portion 20 and the distal cannula 10 is not particularly limited, and for example, the proximal portion 20 and the distal cannula 10 may be coupled by bonding or by a connector such as an outer tube (described later).

[0064] In addition, in some examples, the end of the proximal portion 20 away from the distal portion can be connected to an external monitoring device, etc., outside the patient's body. Since the blood pressure signal measured by the pressure sensor 40 can be transmitted to the monitoring device or other processing device, such as a computer terminal (not shown), the monitoring device or other processing device can display and store the FFR value obtained by calculating the blood pressure signal, providing a reference for subsequent interventional treatment.

[0065] Furthermore, in this embodiment, the proximal portion 20 and the distal cannula 10 may be connected in a continuous manner on the outer surface, or in a discontinuous manner, such as at staggered positions. In some examples, the proximal portion 20 may overlap with the distal cannula 10, while in other examples, the proximal portion 20 may be separated from the distal cannula 10 and connected by a protective tube.

[0066] Furthermore, in this embodiment, the proximal portion 20 (specifically, the other end of the proximal portion 20) extends outside the body along an anatomical structure (e.g., a blood vessel) to connect, for example, to the aforementioned external device (not shown). For ease of illustration, the portion of the proximal portion 20 located outside the patient's body and connected to the external device is not shown in the figures. This portion of the proximal portion 20 generally serves as the portion through which a physician or other person manipulates (e.g., pushes and adjusts the position of the distal portion) the blood pressure measurement catheter 1. By manipulating this portion, the blood pressure measurement catheter 1 can be advanced deeper into or withdrawn from a patient's blood vessel.

[0067] In addition, in this embodiment, the material of the proximal portion 20 is not particularly limited, but preferably a material with a relatively high hardness is used. This ensures that during interventional treatment, the doctor can use the proximal portion 20 to advance the distal cannula 10 (and the imaging ring 30 and pressure sensor 40 disposed thereon) along the medical guidewire 2 into the patient's blood vessel, thereby locating the stenotic lesion.

[0068] In addition, in this embodiment, the proximal portion 20 is generally harder and more rigid than the distal cannula 10 to better enable movement and advancement of the distal cannula 10. In this embodiment, the proximal portion 20 can be made of medical stainless steel, such as hypotube. In addition, in some examples, the proximal portion 20 can also be made of other materials, such as nickel-titanium alloy, nylon, plastic, etc.

[0069] In addition, in this embodiment, the shape of the proximal portion 20 is not particularly limited. In some examples, the proximal portion 20 may be in the shape of an extended long tube. In other examples, the proximal portion 20 may be in the shape of an extended rectangular tube, an elliptical tube, etc. In this embodiment, the proximal portion 20 is preferably in the shape of a long tube from the perspectives of ease of processing and ease of movement within a blood vessel.

[0070] Furthermore, the length of the proximal portion 20 is not particularly limited, as long as the proximal portion 20 is long enough to extend from a predetermined location (e.g., a lesion) within the patient's body (e.g., a vein or artery) to a monitoring device outside the patient's body. A typical length of the proximal portion 20 is, for example, 60 cm to 200 cm. Of course, the proximal portion 20 may also be longer, such as 300 cm, or shorter, such as 50 cm.

[0071] (Developing ring 30)

[0072] Figure 4 1 is a schematic perspective view showing the structure of the developing ring 30 of the intravascular pressure measurement catheter 1 with the developing ring 30 according to the first embodiment of the present disclosure. Figure 5 This is a diagram showing the Figure 2 A locally enlarged schematic diagram of area A1.

[0073] In this embodiment, the developing ring 30 can be made of a material opaque to X-rays, such as platinum. In this case, when exposed to X-rays, the developing ring 30 forms an opaque pattern. This opaque pattern allows doctors to quickly locate the developing ring 30 relative to an anatomical structure (e.g., the coronary arteries of the heart), serving as a location marker.

[0074] Specifically, the position of the developing ring 30 can be used to locate the position of the pressure sensor 40. Therefore, during interventional surgery, the doctor can determine the position of the developing ring 30 through X-ray irradiation or other techniques, and then use the pattern formed under the X-ray to locate the radial position of the pressure sensor 40. This allows for more accurate positioning of the sensing position of the pressure sensor 40, improving the measurement accuracy or precision of the blood pressure measurement catheter 1.

[0075] In this embodiment, the developing ring 30 can be arranged on a side close to the pressure sensor 40 (see Figure 5 In some examples, one end of the developing ring 30 is formed by obliquely cutting the annular tube along a direction forming an angle α with the longitudinal direction L1 of the annular tube (see Figure 4 ). Among them, under X-ray, the pattern of the developing ring 30 can indicate the radial position of the pressure sensor 40 provided on the outer periphery of the distal cannula 10 (refer to the later described Figure 9 In some examples, the angle of α can be between 45° and 90°.

[0076] In some examples, the bevel cutting of the annular tube body can be performed along a direction forming an angle with the length direction L1 of the annular tube body. In some examples, only a portion of one end of the annular tube body can be cut off at an angle, such as Figure 4 The dotted portion is shown. In other examples, both ends of the annular tube body can be beveled simultaneously, that is, a portion of each end of the annular tube body is cut off at an angle. Similarly, the other end of the annular tube body can also be formed by beveling the annular tube body along a direction that forms an angle with the longitudinal direction L1 of the annular tube body (for example, an angle of 180° minus α). In this case, both ends of the developing ring 30 can have a beveled surface, thereby better indicating the radial position of the pressure sensor 40.

[0077] In some examples, under X-ray, the pattern of the developing ring 30 can be displayed as a predetermined pattern only in a predetermined direction. That is, the pattern displayed by the developing ring 30 under X-ray has only one predetermined pattern (in Figure 4 The radial position of the pressure sensor 40 can be indicated by rotating the distal cannula 10 (see the later described example) under X-ray. Figure 9 ), the predetermined pattern of the developing ring 30 provided on the outer periphery of the distal sleeve 10 may be presented as a trapezoid when viewed from the side (see Figure 5 ), in this case, the developing ring 30 cannot be presented as a trapezoid when viewed from any other angle, and such a pattern is unique, thereby being able to indicate the radial position of the pressure sensor 40 through the predetermined pattern.

[0078] In some examples, under X-ray, the predetermined pattern of the developing ring 30 that can indicate the radial position of the pressure sensor 40 can be gradually reduced toward the sensing position of the pressure sensor 40, thereby being able to clearly indicate the radial position of the pressure sensor 40. Figure 5 A trapezoidal predetermined pattern is shown, but the present embodiment is not limited thereto, and the predetermined pattern of the developing ring 30 may also be a triangle, an irregular shape, or the like.

[0079] In this embodiment, under X-ray, when the developing ring 30 of the pressure measuring catheter 1 is in Figure 5 The diagram shows a tapered shape along the radial direction F (i.e., the sensing direction of the pressure sensor 40), thereby indicating the radial position of the pressure sensor 40 disposed on the outer circumference of the distal cannula 10. In this case, an operator or the like can roughly determine the position of the pressure sensor 40 and the sensing position of the pressure sensor 40 by using the distance H between the pressure sensor 40 and the developing ring 30.

[0080] In other examples, under X-rays, the predetermined pattern of the developing ring 30 may be in a gradually shrinking shape along the direction of the outer circumferential surface where the pressure sensor 40 is located.

[0081] In addition, in some examples, the pattern of the developing ring 30 under X-ray can be a trapezoid, triangle, parallelogram or other irregular shapes, etc. Thus, the radial position of the pressure sensor 40 on the outer circumference of the distal cannula 10 can be indicated according to the predetermined pattern.

[0082] Figure 6 It is a schematic perspective structural diagram showing a modified example of the intravascular pressure measurement catheter with a developing ring according to the first embodiment of the present disclosure. Figure 7 It shows Figure 6 The side structural diagram of the intravascular pressure measurement catheter 1 is shown. Figure 8 This is a diagram showing the Figure 7 A locally enlarged schematic diagram of area A2.

[0083] In a modified embodiment, the intravascular pressure measurement catheter 1 may further include an auxiliary imaging ring 50 (see Figure 6 and Figure 7 That is, the intravascular pressure measurement catheter 1 includes two developing rings: a developing ring 30 and an auxiliary developing ring 50. In some examples, the auxiliary developing ring 50 can be positioned on the other side of the pressure sensor 40. One end of the auxiliary developing ring 50 is formed by chamfering the annular tube at an angle to the longitudinal direction L1 of the annular tube. In this case, the pressure sensor 40 is positioned between the developing ring 30 and the auxiliary developing ring 50, thereby improving the accuracy of locating the pressure sensor 40.

[0084] In other examples, the auxiliary developing ring 50 may also be provided on the same side as the developing ring 30 . Thus, the auxiliary developing ring 50 can be used to further confirm whether the pattern under X-ray can correctly indicate the radial position of the pressure sensor 40 .

[0085] like Figure 8 As shown, in some examples, the developing ring 30 near the proximal portion 20 may have a groove for passing the wire 41. Thus, the wire 41 can be allowed to pass through the developing ring 30 to reach the signal path of the proximal portion 20 and fix the wire 41.

[0086] In some examples, the pattern of the developing ring 30 can be the same as the pattern of the auxiliary developing ring 50. This can reduce the possibility of recognition errors caused by unclear patterns. In other examples, the pattern of the developing ring 30 can be different from the pattern of the auxiliary developing ring 50. This can improve the uniqueness of the identifiable direction.

[0087] In some examples, the inner diameter of the developing ring 30 can be greater than or equal to the outer diameter of the pressure measuring catheter 1. In other examples, the developing ring 30 can be fixed to the outer circumference of the pressure measuring catheter 1 by bonding or other methods. Furthermore, the developing ring 30 can be fixed to the distal cannula 10 by welding or other methods, or can be integrally formed with the distal cannula 10.

[0088] In some examples, the Young's modulus of the developing ring 30 is greater than that of the distal cannula 10. This reduces the effect of deformation of the pressure measuring catheter 1 on the developing ring 30. Specifically, the rigidity (or hardness) of the developing ring 30 is greater than that of the distal cannula 10. As a result, even if the distal cannula 10 is bent or squeezed, the developing ring 30 is less likely to deform, thereby reducing the effect of deformation of the pressure measuring catheter 1 on the developing ring 30 and further improving the recognizability of the pattern on the developing ring 30.

[0089] In some examples, the developer ring 30 can be made of stainless steel, a metal alloy, or a hard engineering plastic. The metal alloy can be a cobalt-chromium alloy or a titanium alloy; the hard engineering plastic can be acrylonitrile-butadiene-styrene copolymer (ABS), polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), or polybutylene terephthalate (PBT). Using these materials ensures that the developer ring 30 has sufficient flexural strength, effectively suppressing stress deformation in the developer ring 30 even when the distal cannula 10 is bent.

[0090] (Pressure sensor 40)

[0091] Figure 9 It shows Figure 7 FIG. 1 is a schematic diagram showing the radial position of a pressure sensor disposed on the outer circumference of a distal cannula in an intravascular pressure measurement catheter.

[0092] Figure 9 FIG4 shows the position of the pressure sensor 40 on the outer circumference of the distal cannula 10. In some examples, by rotating the distal cannula 10, the sensing position of the pressure sensor 40 can be positioned by the predetermined pattern of the development ring 30 described above (see FIG4 ). Figure 8 Specifically, the pressure sensor 40 is disposed on the outer circumference of the distal cannula 10. The preset pattern of the developing ring 30 can be confirmed by rotation, thereby determining the position (radial position) of the pressure sensor 40 on the outer circumference of the distal cannula 10. Thus, the sensing position of the pressure sensor 40 can be determined by determining the radial position.

[0093] In some examples, the pressure sensor 40 may include a sensing portion 40a and a lead portion 40b (see FIG. Figure 12 The sensing portion 40a has a sensing area for sensing pressure, and the lead portion 40b derives a blood pressure signal generated by the sensing area. Thus, the pressure sensor 40 can measure blood pressure.

[0094] In this embodiment, the pressure sensor 40 may have a sensing portion 40a oriented in the same direction as the radial position of the pressure sensor 40. In this case, after the radial position of the pressure sensor 40 is obtained by the predetermined pattern of the developing ring 30, the position toward which the sensing portion of the pressure sensor 40 is directed can be obtained, thereby determining the sensing position of the pressure sensor 40.

[0095] In other examples, the pressure sensor 40 can be selected from a piezoresistive pressure sensor 40, a ceramic pressure sensor 40, a diffused silicon pressure sensor 40, a sapphire pressure sensor 40, a capacitive pressure sensor 40, a MEMS pressure sensor 40, or a piezoelectric pressure sensor 40, etc. Therefore, different configurations and designs can be made according to different application scenarios or usage requirements to improve the versatility of the blood pressure measurement catheter 1.

[0096] In some examples, the pressure sensor 40 may be located in the center between the developing ring 30 and the auxiliary developing ring 50, with the pattern of the developing ring 30 and the pattern of the auxiliary developing ring 50 both pointing toward the pressure sensor 40. In this case, the position of the pressure sensor 40 can be further inferred from the positions of the developing ring 30 and the auxiliary developing ring 50, thereby improving the accuracy of identifying the radial position of the pressure sensor 40.

[0097] Furthermore, in this embodiment, the wire 41 connected to the pressure sensor 40 can be connected to a device external to the patient, such as a processor, display, computer, monitor, or other medical device. In some examples, the connecting wire 41 can also be disposed within the proximal portion 20, such that the proximal portion 20 at least partially encases the connecting wire 41. That is, the connecting wire 41 is at least partially contained within the proximal portion 20. Thus, the proximal portion 20 can support and protect the connecting wire 41. Furthermore, in some embodiments, the connecting wire 41 can also be disposed along the outer surface of the proximal portion 20.

[0098] In addition, in this embodiment, the shape of the pressure sensor 40 is not particularly limited, and can be, for example, a rectangular parallelepiped as shown in this embodiment, but can also be other shapes, such as a cylindrical shape, an irregular shape, etc.

[0099] In addition, in this embodiment, at least one of Parylene, silicone, and gel may be coated on the surface of the pressure sensor 40. In this case, the pressure sensor 40 can meet the biocompatibility requirements of interventional surgery.

[0100] In addition, in some examples, the lead portion of the pressure sensor 40 can be fixed to the distal cannula 10 by bonding, such as dispensing glue. In this case, the lead portion can be prevented from separating from the distal cannula 10 during the pushing process of the measuring catheter 1, thereby improving the welding reliability between the lead portion and the sensing portion.

[0101] In some examples, the pressure measuring catheter 1 may include an outer tube (not shown) that covers at least the pressure sensor 40, with an opening provided in the outer tube in a region corresponding to the sensing portion. In other examples, the distal cannula 10 and the proximal portion 20 may be coupled via the outer tube, which may partially or completely cover both the distal cannula 10 and the proximal portion 20, but the present embodiment is not limited thereto. For example, the outer tube and the proximal portion 20 may be integrally formed to form a coupled structure.

[0102] [Second embodiment]

[0103] Figure 10 1 is a schematic perspective view showing the structure of an intravascular pressure measurement catheter 1 with a developing ring 30 according to a second embodiment of the present disclosure. Figure 11 1 is a schematic side view showing the structure of an intravascular pressure measurement catheter 1 with a developing ring 30 according to a second embodiment of the present disclosure.

[0104] The second embodiment of the present disclosure provides an intravascular pressure measuring catheter 1 with a developing ring 30, which includes: a distal sleeve 10, which has a guidewire lumen 11 that can slidably receive a separate medical guidewire 2; a developing ring 30, which is arranged on the distal sleeve 10, and one end of the developing ring 30 is formed by beveling the annular tube body along a direction forming an angle with the length direction L1 of the annular tube body; a pressure sensor 40, which is arranged on the developing ring 30 and is used to measure the blood pressure in the blood vessel and generate a blood pressure signal; and a proximal part 20, which is connected to the distal sleeve 10 and includes a signal path for transmitting the blood pressure signal from the pressure sensor 40, and a connecting catheter 1 for supporting the signal path and moving the distal sleeve 10, wherein, under X-rays, the pattern of the developing ring 30 indicates the position of the pressure sensor 40.

[0105] In the intravascular pressure measuring catheter 1 involved in this embodiment, medical staff and the like can obtain the radial position of the pressure sensor 40 based on the characteristics (predetermined pattern) of the pressure sensor 40 set on the developing ring 30, and thus know the specific position of the pressure sensor 40 by using the predetermined pattern formed by the oblique part of the developing ring 30 under X-rays. This can improve the accuracy of medical staff in identifying the sensing position of the pressure measuring catheter 1.

[0106] The main difference between this embodiment and the first embodiment is that the pressure sensor 40 is provided on the developing ring 30 , thereby enabling the position of the pressure sensor 40 to be more accurately located by the pattern formed by the developing ring 30 under X-rays.

[0107] Figure 12 This is a diagram showing the Figure 11 A partially enlarged schematic diagram of area A3.

[0108] like Figure 12 As shown, in this embodiment, the developing ring 30 may have a stepped portion 31. As described above, the pressure sensor 40 may be specifically disposed on the stepped portion 31 of the developing ring 30. This can further mitigate the impact between the distal cannula 10 and the pressure sensor 40, thereby further improving the measurement precision or accuracy of the pressure sensor 40.

[0109] In other examples, the step 31 can create a gap between the sensing portion 40a of the pressure sensor 40 and the developing ring 30. This prevents contact between the sensing portion 40a of the pressure sensor 40 and the developing ring 30. In this case, even if the developing ring 30 is squeezed or deformed within the blood vessel, the adverse effects on the sensing portion of the pressure sensor 40, particularly the developing ring 30, can be effectively suppressed, thereby further effectively improving the measurement accuracy of the pressure sensor 40.

[0110] Although the present invention has been specifically described above in conjunction with the accompanying drawings and embodiments, it will be understood that the above description does not limit the present invention in any form. Those skilled in the art may modify and change the present invention as needed without departing from the spirit and scope of the present invention, and these modifications and changes all fall within the scope of the present invention.

Claims

1. A catheter for measuring intravascular pressure capable of indicating the position of a pressure sensor, characterized in that: The device comprises: a distal cannula, a developing ring arranged on the distal cannula, and a pressure sensor arranged on the outer circumference of the distal cannula; at least one end of the developing ring is formed by beveling an annular tube along a direction forming an angle with the length direction of the annular tube and is arranged on a side close to the pressure sensor; the pressure sensor is used to measure the blood pressure in the blood vessel and generate a blood pressure signal; under X-rays, the pattern of the developing ring can indicate the radial position of the pressure sensor arranged on the outer circumference of the distal cannula.

2. The intravascular pressure measuring catheter according to claim 1, wherein: The device also includes a proximal portion coupled to the distal cannula, a signal path for transmitting the blood pressure signal from the pressure sensor, and a connecting catheter for supporting the signal path and moving the distal cannula.

3. The intravascular pressure measuring catheter according to claim 1, wherein: It also includes an auxiliary developing ring, which is respectively arranged on both sides of the pressure sensor and one end of the auxiliary developing ring is formed by beveling the annular tube body along a direction forming an angle with the length direction of the annular tube body, or the auxiliary developing ring and the developing ring are arranged on the same side of the pressure sensor.

4. The intravascular pressure measuring catheter according to claim 3, wherein: The pattern of the developing ring is the same as or different from the pattern of the auxiliary developing ring.

5. The intravascular pressure measuring catheter according to claim 3, wherein: When the pressure sensor is located at the center between the developing ring and the auxiliary developing ring, the pattern of the developing ring and the pattern of the auxiliary developing ring both point to the pressure sensor.

6. The intravascular pressure measuring catheter according to claim 1, wherein: Under X-rays, the pattern of the developing ring is gradually shrunk toward the sensing position of the pressure sensor, and the radial position is the sensing position of the pressure sensor.

7. The intravascular pressure measuring catheter according to claim 1, wherein: The distal sleeve has a guidewire inner cavity for slidably receiving a separate medical guidewire, and the distal sleeve is in the shape of an extended circular tube.

8. An intravascular pressure measuring catheter capable of indicating the position of a pressure sensor, characterized in that: include: A distal cannula, a developing ring arranged on the distal cannula, a pressure sensor arranged on the developing ring, and a proximal portion connected to the distal cannula; the distal cannula has a guidewire lumen for slidably receiving a separate medical guidewire; at least one end of the developing ring is formed by beveling an annular tube along a direction forming an angle with the length direction of the annular tube; the pressure sensor is used to measure the blood pressure in the blood vessel and generate a blood pressure signal; the proximal portion includes a signal path for transmitting the blood pressure signal from the pressure sensor, and a connecting catheter for supporting the signal path and moving the distal cannula, the rigidity of the proximal portion is greater than that of the distal cannula; under X-rays, the pattern of the developing ring indicates the position of the pressure sensor.

9. The intravascular pressure measuring catheter according to claim 8, wherein: The developing ring has a stepped portion, and the pressure sensor is provided on the stepped portion.

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