Pressure measuring catheter, pressure measuring system, key lesion area identification system and storage medium

Abstract

This application relates to a pressure measuring catheter, a pressure measuring system, a system for identifying critical lesion areas, and a storage medium. The pressure measuring catheter comprises a tubular body with an inner lumen and several pressure sensors. The tubular body comprises a distal tube and a proximal tube that are connected to each other. The pressure sensors are arranged in an array along the axial direction of the distal tube, with the area between two pressure sensors serving as the measurement area. The solution provided in this application simplifies the measurement process and facilitates vascular pressure measurement.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a pressure measuring catheter, a pressure measuring system, a key lesion area identification system, and a storage medium. Background Art

[0002] Cardiovascular disease has gradually become the greatest threat to human health, ranking first in both morbidity and mortality. Currently, cardiovascular intervention has become an important treatment for vascular stenosis. In 1993, Nico Pijls et al. proposed the FFR (Fractional Flow Reserve) metric, which refers to the ratio of the maximum blood flow available to the myocardial region supplied by a coronary artery stenosis to the theoretically maximum blood flow available to the same region under normal conditions. Specifically, it is the ratio of the mean intracoronary pressure distal to the stenosis (Pd) at maximum myocardial hyperemia to the mean aortic pressure at the coronary ostium (Pa). FFR technology can assess the degree of cardiovascular stenosis before surgery, providing an accurate functional assessment for determining the need for stent placement. Furthermore, after stent implantation, postoperative FFR measurement is used to assess the therapeutic efficacy of the procedure. Higher FFR values ​​after percutaneous coronary intervention (PCI) are associated with lower rates of revascularization, making FFR a valuable tool for post-PCI assessment.

[0003] In related technologies, when performing FFR measurements, in order to confirm the location of vascular lesions, the catheter is first inserted deep into the blood vessel and the pressure sensor is passed through the location of the vascular lesion to measure the pressure and record the pressure data. The catheter is then withdrawn to return the pressure sensor to the coronary artery orifice. During the withdrawal process, changes in pressure data are observed and recorded to identify the location of the corresponding blood vessel where the pressure suddenly begins to rise and disappear, and the measurement steps are complicated. Summary of the Invention

[0004] In order to solve or partially solve the problems existing in the related art, the present application provides a pressure measuring catheter, a pressure measuring system, a key lesion area identification system and a storage medium, which can simplify the measurement steps, accurately and quickly confirm the location of vascular lesions, and facilitate the operator to perform vascular pressure measurement.

[0005] In a first aspect, the present application provides a pressure measuring catheter, comprising a tube body having an inner cavity and a plurality of pressure sensors, wherein:

[0006] The tube body comprises a distal tube and a proximal tube connected to each other;

[0007] The plurality of pressure sensors are distributed in an axial array along the distal tube, wherein the area between two pressure sensors is a measurement area.

[0008] In some embodiments, a side wall of the distal tube is provided with an installation groove, and a plurality of the pressure sensors are respectively installed in the installation groove.

[0009] In some embodiments, the number of the mounting slots is the same as the number of the pressure sensors, and the individual pressure sensors are respectively installed in corresponding mounting slots.

[0010] In some embodiments, a plurality of glue injection holes communicating with the inner cavity are opened on the wall of the distal tube, and the pressure sensor is fixed to the distal tube by adhesive injected through the glue injection holes.

[0011] In some embodiments, the glue injection hole is disposed adjacent to the mounting groove, and the glue injection hole is communicated with the adjacent mounting groove.

[0012] In some embodiments, the distal tube is a single-tube integrally formed structure or a multi-tube spliced ​​structure, and the distal tube is a constant-diameter tube or a variable-diameter tube.

[0013] In some embodiments, the tube body is formed integrally with a distal tube and a proximal tube; or

[0014] The tube body is formed by splicing a distal tube and a proximal tube;

[0015] Wherein, the tube body is a constant diameter tube or a reducing diameter tube.

[0016] In some embodiments, the distance between two adjacent pressure sensors is 0.5 cm to 10 cm.

[0017] A second aspect of the present application provides a pressure measurement system, comprising the above-mentioned pressure measurement catheter and a host;

[0018] The pressure measuring catheter is used to collect pressure measurement values ​​in the vascular lesion area;

[0019] The host is connected to the pressure measuring catheter and is used to obtain pressure measurement values ​​corresponding to the multiple pressure sensors in the pressure measuring catheter, and obtain an FFR value or a pressure drop value based on the pressure measurement values ​​corresponding to two pressure sensors.

[0020] A third aspect of the present application provides a system for identifying critical lesion areas, comprising the above-mentioned pressure measuring catheter and a host;

[0021] The pressure measuring catheter is used to collect pressure measurement values ​​in the vascular lesion area;

[0022] The host is connected to the pressure measuring catheter and is used to obtain the pressure measurement values ​​corresponding to the multiple pressure sensors in the pressure measuring catheter, and obtain the FFR value or pressure drop value based on the pressure measurement values ​​corresponding to two pressure sensors; compare the FFR values ​​or pressure drop values ​​of at least two measurement areas of the same length, and determine the key lesion area based on the comparison results.

[0023] In some embodiments, comparing the FFR values ​​or pressure drop values ​​of at least two measurement regions of the same length comprises:

[0024] The areas where any two adjacent pressure sensors are located are selected as measurement areas, and the FFR values ​​or pressure drop values ​​of the adjacent measurement areas having the same length are compared.

[0025] In some embodiments, determining the key lesion area based on the comparison result includes:

[0026] Determining that the measurement area corresponding to the FFR value with the smallest numerical value among the FFR values ​​is the critical lesion area; or

[0027] The measurement area corresponding to the pressure drop value with the largest value among the pressure drop values ​​is determined to be the key lesion area.

[0028] A fourth aspect of the present application provides a computer-readable storage medium having a computer program stored thereon, wherein the computer program implements a pressure measurement method when executed by a processor;

[0029] The pressure measurement method comprises:

[0030] obtaining pressure measurements from a plurality of pressure sensors within the distal tube;

[0031] An FFR value or a pressure drop value is obtained according to the pressure measurement values ​​corresponding to the two pressure sensors.

[0032] A fifth aspect of the present application provides a computer-readable storage medium having a computer program stored thereon, wherein the computer program implements a method for identifying a key lesion area when executed by a processor;

[0033] The method for identifying key lesion areas comprises:

[0034] obtaining pressure measurements from a plurality of pressure sensors within the distal tube;

[0035] Obtaining an FFR value or a pressure drop value according to the pressure measurement values ​​corresponding to the two pressure sensors;

[0036] Comparing the FFR values ​​or pressure drop values ​​of at least two measurement areas of equal length;

[0037] The critical lesion area is determined based on the comparison results.

[0038] In some embodiments, comparing the FFR values ​​or pressure drop values ​​of at least two measurement regions of the same length comprises:

[0039] The areas where any two adjacent pressure sensors are located are selected as measurement areas, and the FFR values ​​or pressure drop values ​​of the adjacent measurement areas having the same length are compared.

[0040] In some embodiments, determining the key lesion area based on the comparison result includes:

[0041] Determining that the measurement area corresponding to the FFR value with the smallest numerical value among the FFR values ​​is the critical lesion area; or

[0042] The measurement area corresponding to the pressure drop value with the largest value among the pressure drop values ​​is determined to be the key lesion area.

[0043] The technical solution provided by the present application may include the following beneficial effects: by using several pressure sensors in the distal tube, the calibration steps of the internal pressure sensors and the external invasive pressure flow sensors before measurement are reduced, making the operation simpler and more convenient, and the vascular lesion area can be confirmed more quickly; and the measurement of the intravascular pressure gradient can be realized, while simplifying the operation of withdrawing the catheter or performing multiple measurements to clarify the vascular lesion area, and the location and range of the vascular lesion can be identified more quickly and accurately, with high lesion positioning accuracy, which can better provide guidance on whether stent implantation is necessary, and provide guidance on the therapeutic effect of PCI surgery.

[0044] The technical solution of the present application can also: by directly fixing the pressure sensor inside the tube body, the specific fixing base and other parts required to fix the pressure sensor can be omitted. On the one hand, the fixing base, core wire and other parts that fix the pressure sensor inside the tube body for measurement can be reduced, thereby avoiding the expansion of the tube diameter, which is conducive to the catheter entering the blood vessel, and the catheter is not easy to cause damage to the blood vessel during the process of penetrating into the blood vessel and retracting; on the other hand, it can reduce production and use costs and reduce the generation of disposable medical waste.

[0045] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The above and other objects, features and advantages of the present application will become more apparent by describing in more detail the exemplary embodiments of the present application in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments of the present application.

[0047] Figure 1 1 is a schematic diagram of the overall structure of a pressure measuring catheter shown in an embodiment of the present application;

[0048] Figure 2 1 is a schematic structural diagram of the distal end tube of the pressure measuring catheter shown in an embodiment of the present application;

[0049] Figure 3 1 is a schematic structural diagram of a pressure measuring catheter in which the distal end tube is a reducing tube as shown in an embodiment of the present application;

[0050] Figure 4 This is a schematic diagram of one connection structure of the distal tube and the proximal tube of the pressure measuring catheter shown in an embodiment of the present application;

[0051] Figure 5 Schematic diagram of the structure of the pressure measurement system shown in the embodiment of the present application;

[0052] Figure 6 This is a schematic diagram of a pressure measuring catheter in use according to an embodiment of the present application;

[0053] Figure 7 1 is a schematic structural diagram of one measurement area of ​​a pressure measurement system shown in an embodiment of the present application;

[0054] Figure 8 1 is a schematic structural diagram of one measurement area of ​​a pressure measurement system shown in an embodiment of the present application;

[0055] Figure 9 It is a structural schematic diagram of one of the measurement areas of the pressure measurement system shown in an embodiment of the present application.

[0056] Reference numerals:

[0057] 10. Pressure sensor; 10A, sensor No. 1; 10B, sensor No. 2; 10C, sensor No. 3; 10D, sensor No. 4;

[0058] 20. Distal tube; 21. Mounting slot; 22. Glue injection hole;

[0059] 30, proximal tube;

[0060] 40. Measurement area; 40A. Measurement area 1; 40B. Measurement area 2;

[0061] 50. Areas of vascular lesions. DETAILED DESCRIPTION

[0062] The following describes embodiments of the present application in more detail with reference to the accompanying drawings. Although the accompanying drawings illustrate embodiments of the present application, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. Rather, these embodiments are provided to make the present application more thorough and complete, and to fully convey the scope of the present application to those skilled in the art.

[0063] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. As used in this application and the appended claims, the singular forms "a," "an," "the," and "the" are intended to include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

[0064] It should be understood that although the terms "first", "second", "third", etc. may be used in this application to describe various information, this information should not be limited to these terms. These terms are only used to distinguish information of the same type from each other. For example, without departing from the scope of this application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0065] In related technologies, when performing FFR measurements, in order to confirm the location of vascular lesions, the catheter is first inserted deep into the blood vessel and the pressure sensor is passed through the location of the vascular lesion to measure the pressure and record the pressure data. The catheter is then withdrawn to return the pressure sensor to the coronary artery orifice. During the withdrawal process, changes in pressure data are observed and recorded to identify the location of the corresponding blood vessel where the pressure suddenly begins to rise and disappear, and the measurement steps are complicated.

[0066] In response to the above problems, an embodiment of the present application provides a pressure measuring catheter that can simplify the measurement steps, accurately and quickly confirm the location of vascular lesions, and facilitate the operator to perform pressure measurement work.

[0067] The technical solutions of the embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0068] See also Figure 1 The pressure measuring catheter includes a tube body with an inner lumen and several pressure sensors 10. The tube body includes a distal tube 20 and a proximal tube 30, which are connected to each other. The distal tube 20 is the section of the tube body away from the operator, and the proximal tube 30 is the section of the tube body closer to the operator. The pressure sensors 10 are disposed within the distal tube 20, located on the same side of the distal tube 20, and arranged in an array along the axial direction of the distal tube 20. The area between any two pressure sensors 10 is a measurement area 40. The cables of the pressure sensors 10 are passed through the tube body.

[0069] There is no limit to the number of pressure sensors 10 within the distal tube 20; it can be two or more. The area between two adjacent pressure sensors 10 can be considered a measurement area 40; the area between two spaced-apart pressure sensors 10 can also be considered a measurement area. A measurement area 40 can also be defined by two spaced-apart pressure sensors 10. The number of measurement areas 40 increases as the number of pressure sensors 10 increases, thereby enabling the acquisition of pressure variations across different locations in the blood vessel.

[0070] By placing several pressure sensors 10 in the distal tube 20, the environment in which each pressure sensor 10 is located is the same during the measurement process. There is no need to use an invasive pressure sensor to calibrate the pressure sensor 10 in the distal tube 20 before measurement, which simplifies the measurement steps and makes the measurement work simpler and more convenient. Furthermore, since the environment in which each pressure sensor 10 is located is the same, the pressure measurement results can be prevented from being affected by the invasive pressure sensor outside the body, and the measurement results are more accurate.

[0071] Moreover, by distributing a plurality of pressure sensors 10 in an array, accurate measurement of the intravascular pressure gradient can be achieved, and the location and range of vascular lesions can be more accurately identified, providing accurate pre-operative and post-operative guidance for PCI surgery; at the same time, the operation of withdrawing the catheter to clarify the location of vascular lesions is omitted, and the operation of multiple measurements to clarify the location of vascular lesions can also be omitted, further simplifying the measurement steps, and more quickly and accurately determining the location and range of vascular lesions.

[0072] In some embodiments, the distance between two adjacent pressure sensors 10 is 0.5 cm to 10 cm. Furthermore, the distance between two adjacent pressure sensors 10 can be 2 cm to 4 cm. For example, the distance between two pressure sensors 10 can be 0.5 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 8 cm, or 10 cm. The distance between one pressure sensor 10 and its two adjacent pressure sensors 10 can be the same. This is for example only and is not intended to be limiting.

[0073] In some embodiments, see Figure 2The side wall of the distal tube 20 is provided with a mounting groove 21 , and a plurality of pressure sensors 10 are respectively mounted in the mounting grooves 21 . The mounting groove 21 provides positioning, limiting, and securing for the pressure sensor 10 within the distal tube 20. First, the mounting groove 21 can be used as a reference to quickly determine the corresponding position of the pressure sensor 10 within the distal tube 20. Second, the mounting groove 21 is provided for mounting the pressure sensor 10, so that the pressure sensor 10 does not occupy excessive space within the distal tube 20, thus avoiding the need to increase the diameter of the tube body due to the use of the pressure sensor 10. This allows the pressure measuring catheter to penetrate deeper into the blood vessel with a smaller diameter, facilitating the pressure measuring catheter's entry into the blood vessel and reducing damage to the blood vessel during entry. Third, the provision of the mounting groove 21 for mounting the pressure sensor 10 eliminates the need for a specific fixing base for the pressure sensor 10 to secure it within the distal tube 20. This not only reduces the production cost of the pressure measuring catheter, but also reduces the number of components such as the fixing base within the distal tube 20. This eliminates the need to reserve space for the base within the lumen of the tube body, allowing the tube body to have a smaller diameter, further facilitating the insertion of the pressure measuring catheter into the blood vessel and making it suitable for use in blood vessels of varying diameters.

[0074] In some embodiments, the number of mounting slots 21 may be set to be less than the number of pressure sensors 10. For example, if there is only one mounting slot 21, each pressure sensor 10 is installed in the same mounting slot 21, and each pressure sensor 10 is distributed in an array along the axial direction of the distal tube 20 within the mounting slot 21.

[0075] In other embodiments, the number of mounting slots 21 is the same as the number of pressure sensors 10, and the mounting slots 21 are arranged in an array along the axial direction of the distal tube 20, with individual pressure sensors 10 installed in corresponding mounting slots 21. Providing the same number of mounting slots 21 as the number of pressure sensors 10 allows for precise positioning of the pressure sensors 10 within the distal tube 20, maintaining consistent spacing between adjacent pressure sensors 10, and thus enabling accurate measurement of intravascular pressure gradients. Furthermore, because the mounting slots 21 separate the pressure sensors 10, interference between the pressure sensors 10 is less likely to occur during installation, allowing for quick installation of the pressure sensors 10 within the distal tube 20. Furthermore, the area of ​​the grooves in the sidewalls of the distal tube 20 can be reduced, thereby avoiding a reduction in the structural strength of the distal tube 20.

[0076] In some embodiments, the wall of the distal tube 20 is provided with a plurality of glue injection holes 22 that communicate with the inner cavity. After the pressure sensor 10 is inserted into the distal tube 20 through the inner cavity of the tube body, adhesive can be injected into the inner cavity of the distal tube 20 through the glue injection holes 22, thereby bonding and fixing the pressure sensor 10 to the distal tube 20. The cured adhesive automatically seals the glue injection holes 22, thereby sealing the tube body. The method of injecting adhesive through the glue injection holes 22 makes the fixing method of the pressure sensor 10 in the distal tube 20 simple and easy to operate. Moreover, no specific fixing base or other parts are required to achieve the purpose of fixing the pressure sensor 10 in the distal tube 20. The diameter of the tube body can be reduced, thereby reducing the resistance encountered by the tube body when penetrating into the blood vessel and when withdrawing from the blood vessel, making it easier for the operator to perform measurement operations and reducing damage to the blood vessel caused by the measurement catheter during advancement or withdrawal.

[0077] In some embodiments, the number of glue injection holes 22 and pressure sensors 10 can be the same or different, and this is not limited here. For example, a plurality of glue injection holes 22 can be distributed in an axial array along the wall of the distal tube 20, with a single pressure sensor 10 corresponding to a single glue injection hole 22. Alternatively, the plurality of glue injection holes 22 can be grouped to form glue injection hole groups, each glue injection hole group having the same number of glue injection holes 22, each glue injection hole group distributed in an array along the wall of the distal tube 20, with a single pressure sensor 10 corresponding to a group of glue injection hole groups. Injecting adhesive into the distal tube 20 through the glue injection hole groups can more stably secure the single pressure sensor 10 within the distal tube 20, preventing the pressure sensor 10 from falling off.

[0078] In some embodiments, after injecting adhesive into the inner cavity of the distal tube 20 through the glue injection hole 22, the cable transmission line of the pressure sensor 10 can also be bonded and fixed in the distal tube 20, so that the cable transmission lines of each pressure sensor 10 are arranged in an orderly manner in the inner cavity of the tube body, avoiding the cable transmission lines from interfering with the installation of other pressure sensors 10 in the distal tube.

[0079] In some embodiments, the wall of the distal tube 20 is provided with both a mounting groove 21 and a glue injection hole 22. In this case, the glue injection hole 22 is disposed adjacent to the mounting groove 21 and connects the mounting groove 21 to the glue injection hole 22. When there are multiple glue injection holes 22, a single group of glue injection holes is provided around the periphery of the mounting groove 21. First, the pressure sensor 10 is introduced into the distal tube 20 through the inner cavity of the tube body and placed into the mounting groove 21. Adhesive is then injected into the mounting groove 21 through the glue injection hole 22, thereby securing the pressure sensor 10 placed in the mounting groove 21 to the groove wall of the mounting groove 21 and the inner wall of the distal tube 20. This allows the pressure sensor 10 to be more stably secured within the distal tube 20 and prevents it from falling off. Furthermore, the injection of adhesive can seal the mounting groove 21, i.e., fill the mounting groove 21 with glue, thereby sealing the distal tube 20 and preventing the intravascular environment from communicating with the intravascular environment, thereby affecting the accurate measurement of vascular pressure.

[0080] In some embodiments, the surface of the distal tube 20 is covered with a coating, which is a biocompatible coating, thereby forming a protective film for the distal tube 20 . The coating can further seal the glue injection hole 22 or the installation groove 21 .

[0081] In some embodiments, the distal tube 20 can be made of a metal material or a polymer material. Metal materials such as nickel-titanium alloy and stainless steel are examples and are not limiting. The distal tube 20 made of a polymer material can be made into a single-layer tube or a multi-layer composite tube.

[0082] In some embodiments, the distal tube 20 may be a constant diameter tube or a reducing diameter tube. Figure 3 and Figure 4 When the distal tube 20 is a reducer, the distal tube 20 body can have a uniformly variable diameter or a stepped variable diameter structure, and the diameter of the distal end of the distal tube 20 is smaller than the diameter of the proximal end of the distal tube 20. The small diameter of the distal end of the distal tube 20 facilitates the distal tube 20 to pass through the narrow part of the blood vessel, and the larger diameter of the proximal end of the distal tube 20 has better support strength, which can provide better pushing support force for the tube body to penetrate into the blood vessel.

[0083] In some embodiments, the distal tube 20 can be an integrally formed structure or a multi-tube splicing structure. That is, the distal tube 20 can be a single constant-diameter tube or a single variable-diameter tube structure. When the distal tube is a single variable-diameter tube, the variable-diameter tube body is formed by stretching and deformation. The distal tube 20 can also be formed by splicing multiple constant-diameter tubes of the same diameter, using bonding, welding, etc.; the distal tube 20 can also be formed by splicing multiple constant-diameter tubes of different diameters, in which case the diameter of the constant-diameter tube at the distal end of the distal tube 20 increases relative to the diameter of the constant-diameter tube at the proximal end of the distal tube 20, resulting in a stepped variable-diameter structure. The splicing methods include bonding, welding, and sheathing. The distal tube 20 can also be formed by splicing multiple variable-diameter tubes, with the diameter of the distal end of a single variable-diameter tube smaller than the diameter of its proximal end, resulting in a uniform variable-diameter structure or a stepped deformed structure. The splicing methods include bonding, welding, etc.

[0084] In some embodiments, the distal tube 20 and the proximal tube 30 can be integrally formed. In this case, the tube body can be a constant diameter tube or a reducer. When the tube body is a reducer, the tube body can have a uniform or stepped diameter reduction structure, and the reducer body of the tube body is obtained by stretching and deforming. The diameter of the distal end of the tube body is smaller than that of the proximal end. The smaller diameter at the distal end facilitates passage through narrowed blood vessels, while the larger diameter at the proximal end provides greater support strength, facilitating operator use and providing better support for pushing the tube deeper into the blood vessel.

[0085] In some embodiments, the tube body can be formed by splicing the distal tube 20 and the proximal tube 30. Specifically, the tube body can be spliced ​​by splicing the distal tube 20 and the proximal tube 30 of the same diameter, and the splicing methods include bonding, welding, and sleeve fitting. If the distal tube 20 and the proximal tube 30 are both equal-diameter tubes, the tube body is an equal-diameter tube; if the distal tube 20 and the proximal tube 30 are both reducer tubes, the tube body is a reducer tube. Figure 4 The tube body can also be spliced ​​together by a distal tube 20 and a proximal tube 30 of different diameters, and the splicing methods include bonding, welding, and sheathing; if the distal tube 20 and the proximal tube 30 are both equal-diameter tubes, and the diameters of the distal tube 20 and the proximal tube 30 are different, the tube body is a reducing tube; if the distal tube 20 and the proximal tube 30 are both reducing tubes, and the diameters of the distal tube 20 and the proximal tube 30 are different, the tube body is a reducing tube.

[0086] Corresponding to the embodiment of the pressure measuring catheter described above, see Figure 5 The present application also provides a pressure measurement system 100 , including a pressure measurement catheter 110 , a host 120 , a guide wire 130 and an injection pump 140 .

[0087] The pressure measuring catheter 110 is used to establish an interventional channel and collect pressure measurements of the vascular lesion area 50. The blood vessel may be a tubular artery.

[0088] The plurality of pressure sensors 10 in the distal end of the pressure measuring catheter 110 can obtain a plurality of corresponding pressure measurement values. Before use, the plurality of pressure sensors 10 in the pressure measuring catheter 110 are first zeroed.

[0089] The pressure measuring catheter 110 is delivered into the body via a guidewire 130. After the pressure sensor 10 at the distal end of the pressure measuring catheter 110 reaches the coronary artery ostium, an EQ (equalizer) operation is performed on the multiple pressure sensors 10 to ensure consistent readings across all pressure sensors 10 within the pressure measuring catheter 110. For example, the EQ operation can be performed using the average value of all pressure sensors 10 as a reference, or the value of a single pressure sensor 10, such as the pressure sensor 10 at the distal end of the pressure measuring catheter 110, or an external invasive pressure sensor (in this case, the pressure measuring system 100 also includes an invasive pressure sensor to provide a coronary pressure reference for the pressure sensor 10 within the pressure measuring catheter 110).

[0090] Combine Figure 6 The pressure measuring catheter 110 is delivered into the coronary artery via a guidewire 130, with the pressure sensor 10 at the distal end of the distal tube 20 passing through the vascular lesion site and the pressure sensor 10 at the proximal end of the distal tube 20 not reaching the vascular lesion site. In other words, the total measurement area corresponding to all pressure measuring catheters 110 now completely covers the vascular lesion area 50. A coronary vasodilator drug is injected into the coronary artery via a syringe pump 140, causing the coronary artery to reach a congested state. The pressure in this state of coronary congestion is then measured using the multiple pressure sensors 10.

[0091] The host 120 is connected to the pressure measuring catheter 110 , and is used to obtain pressure measurement values ​​corresponding to the pressure sensors 10 in the pressure measuring catheter 110 , and obtain an FFR value or a pressure drop value according to the pressure measurement values ​​corresponding to two pressure sensors 10 .

[0092] In some embodiments, the FFR value or pressure drop value is obtained based on the pressure measurement values ​​corresponding to the two pressure sensors 10. Two adjacent pressure sensors 10 may be selected to measure the pressure measurement values ​​to obtain the FFR value or pressure drop value. Figure 7 , set the pressure sensor at the distal end of the distal tube 20 to be sensor No. 1 10A, the pressure sensor adjacent to sensor No. 10A to be sensor No. 2 10B, and the measurement area 40 to be the area between sensor No. 10A and sensor No. 2 10B. At this time, the pressure value measured by sensor No. 10A is Pd1, the pressure value measured by sensor No. 2 10B is Pd2, the FFR value of the measurement area 40 is the ratio of Pd1 to Pd2, and the pressure drop value of the measurement area 40 is the difference between Pd2 and Pd1.

[0093] In some embodiments, the FFR value or pressure drop value is obtained based on the pressure measurement values ​​corresponding to the two pressure sensors 10. The pressure measurement values ​​of the two pressure sensors 10 set at intervals can be selected to obtain the FFR value or pressure drop value. Figure 8 , set the pressure sensor at the distal end of the distal tube 20 to be sensor No. 1 10A, the pressure sensor separated from sensor No. 10A to be sensor No. 3 10C, and the measurement area 40 to be the area between sensor No. 10A and sensor No. 3 10C. At this time, the pressure value measured by sensor No. 10A is Pd1, the pressure value measured by sensor No. 3 10C is Pd3, the FFR value of the measurement area 40 is the ratio of Pd1 to Pd3, and the pressure drop value of the measurement area 40 is the difference between Pd3 and Pd1.

[0094] In some embodiments, the FFR value or pressure drop value can be obtained based on the pressure measurement values ​​corresponding to the two pressure sensors 10. The pressure measurement values ​​of the two pressure sensors 10 with the greatest distance between them can be selected to obtain the FFR value. Figure 9 , set the pressure sensor 10 at the distal end of the distal tube 20 to be sensor No. 1 10A, the pressure sensor 10 farthest from sensor No. 10A to be sensor No. 4 10D, and the measurement area 40 to be the area between sensor No. 10A and sensor No. 4 10D. At this time, the pressure value measured by sensor No. 10A is Pd1, the pressure value measured by sensor No. 4 10D is Pd4, the FFR value of the measurement area 40 is the ratio of Pd1 to Pd4, and the pressure drop value of the measurement area 40 is the difference between Pd4 and Pd1.

[0095] The pressure measurement system of the embodiment of the present application can synchronously measure the pressure values ​​of different parts of the blood vessels through a plurality of pressure sensors arranged in the distal tube, thereby quickly and accurately identifying the location and range of the vascular lesion site; the use of the blood pressure gradient measurement method can omit the operation of withdrawing the pressure measuring catheter to further confirm the vascular lesion site, and can also omit the step of calibrating the internal pressure sensor 10 using an invasive pressure sensor outside the body, thereby simplifying the measurement steps.

[0096] With reference to the aforementioned pressure measurement system, the present application further provides a system for identifying critical lesion areas, including a pressure measurement catheter 110 , a host 120 , a guide wire 130 and an injection pump 140 .

[0097] The pressure measuring catheter 110 , the guide wire 130 and the injection pump 140 can be referred to the description of the pressure measuring system 100 above, and will not be described in detail here.

[0098] The host 120 is connected to the pressure measuring catheter 110. The host 120 is used to obtain the pressure measurement values ​​corresponding to the multiple pressure sensors 10 in the pressure measuring catheter 110, and to obtain the FFR value or pressure drop value based on the pressure measurement values ​​corresponding to the two pressure sensors 10. The host 120 is also used to compare the FFR values ​​or pressure drop values ​​of at least two measurement areas 40 of the same length, and to determine the key lesion area based on the comparison results.

[0099] In some embodiments, the host 120 is used to compare the FFR values ​​or pressure drop values ​​of at least two measurement areas 40 with the same length. The areas where any two adjacent pressure sensors are located can be selected as measurement areas to compare the FFR values ​​or pressure drop values ​​of adjacent measurement areas 40 with the same length.

[0100] For example, combined with Figure 6 The three consecutive pressure sensors in distal tube 20 are assumed to be sensor 10A, sensor 2 10B, and sensor 3 10C. The spacing between sensor 10A and sensor 10B, and between sensor 10B and sensor 3 10C is the same. The measurement area 40 between sensor 10A and sensor 10B is measurement area 1 40A, and the measurement area 40 between sensor 10B and sensor 3 10C is measurement area 2 40B. The lengths of measurement areas 10A and 40B are the same. The pressure measurement value of sensor 10A is Pd1, the pressure measurement value of sensor 10B is Pd2, and the pressure measurement value of sensor 3 10C is Pd3. The FFR value of measurement area No. 1 40A is obtained by the ratio of Pd1 and Pd2, and the FFR value of measurement area No. 2 40B is obtained by the ratio of Pd2 and Pd3, and the numerical values ​​of measurement area No. 1 40A and measurement area No. 2 40B are compared; the pressure drop value of measurement area No. 1 40A is obtained by the difference between Pd2 and Pd1, and the pressure drop value of measurement area No. 2 40B is obtained by the difference between Pd3 and Pd2, and the numerical values ​​of measurement area No. 1 40A and measurement area No. 2 40B are compared.

[0101] In other embodiments, the areas where any two adjacent pressure sensors are located can be selected as measurement areas, the FFR values ​​or pressure drop values ​​of non-adjacent measurement areas 40 with the same length can be compared, and the key lesion area can be determined based on the comparison results; or, the areas where any two non-adjacent pressure sensors are located can be selected as measurement areas, the FFR values ​​or pressure drop values ​​of measurement areas 40 with the same length can be compared, and the key lesion area can be determined based on the comparison results.

[0102] The FFR values ​​or pressure drop values ​​of the measurement regions 40 that are compared are at least the FFR values ​​or pressure drop values ​​of two measurement regions 40 .

[0103] In some embodiments, determining the key lesion area based on the comparison result may be determining that the measurement area corresponding to the smallest FFR value among the FFR values ​​is the key lesion area. For example:

[0104] The FFR values ​​of the first measurement area 40A and the second measurement area 40B are compared. If the FFR value of the first measurement area 40A is smaller than that of the second measurement area 40B, it indicates that the vascular stenosis in the first measurement area 40A is more severe than that in the second measurement area 40B, and the first measurement area 40A is determined to be a critical lesion area.

[0105] In some embodiments, determining the key lesion area based on the comparison result may be determining that the measurement area corresponding to the largest pressure drop value among the pressure drop values ​​is the lesion area. For example:

[0106] The pressure drop values ​​of the first measurement area 40A and the second measurement area 40B are compared. If the pressure drop value of the first measurement area 40A is greater than that of the second measurement area 40B, it means that the vascular stenosis in the first measurement area 40A is more severe than that in the second measurement area 40B, and the first measurement area 40A is determined to be a diseased area.

[0107] In the embodiment of the present application, the pressure gradient in the blood vessel is measured by a plurality of pressure sensors, and the FFR value or pressure drop value between different pressure sensors is used to judge the location of the vascular lesion and the stenosis, the size of the lesion, etc., and the positioning accuracy of the lesion is high. Moreover, there is no need to use an invasive pressure sensor as a reference, thereby avoiding the influence of factors such as the different environments between the invasive pressure sensor and the internal pressure sensor in the pressure measuring catheter, and the high or low position of the invasive pressure sensor outside the body on the FFR value or pressure drop value. Moreover, the operation of withdrawing the pressure measuring catheter to further determine the location of the vascular lesion can be omitted, thereby avoiding the influence of the FFR value or pressure drop value caused by the sudden increase or sudden decrease of the pressure measurement value due to factors such as the deep insertion of the catheter when withdrawing the pressure measuring catheter, making the FFR value or pressure drop value more accurate. The more accurate the FFR value and pressure drop value, the more accurate the judgment of the extent of the lesion, which helps to provide preoperative guidance for PCI surgery, change surgical strategies, and also helps to evaluate the therapeutic effect of PCI surgery.

[0108] Corresponding to the aforementioned pressure measurement system, the present application also provides a computer-readable storage medium (or non-temporary machine-readable storage medium or machine-readable storage medium) on which a computer program (or executable code or computer instruction code) is stored. When the computer program (or executable code or computer instruction code) is executed by a processor, a pressure measurement method is implemented.

[0109] The pressure measurement method includes:

[0110] S110, obtaining pressure measurement values ​​of several pressure sensors in the distal tube;

[0111] S120 : Obtain an FFR value or a pressure drop value according to the pressure measurement values ​​corresponding to the two pressure sensors.

[0112] Corresponding to the aforementioned system for identifying critical lesion areas, the present application also provides a computer-readable storage medium (or non-temporary machine-readable storage medium or machine-readable storage medium) on which a computer program (or executable code or computer instruction code) is stored. When the computer program (or executable code or computer instruction code) is executed by a processor, a method for identifying critical lesion areas is implemented.

[0113] Among them, the methods for identifying key lesion areas include:

[0114] S110, obtaining pressure measurement values ​​of a plurality of pressure sensors in the distal tube;

[0115] S120, obtaining an FFR value or a pressure drop value according to the pressure measurement values ​​corresponding to the two pressure sensors;

[0116] S130, comparing FFR values ​​or pressure drop values ​​of at least two measurement areas of the same length;

[0117] S140. Determine the key lesion area based on the comparison result.

[0118] In some embodiments, comparing the FFR values ​​or pressure drop values ​​of measurement areas of at least the same length can be performed by selecting the areas where any two adjacent pressure sensors are located as the measurement areas and comparing the FFR values ​​or pressure drop values ​​of adjacent measurement areas of the same length; or by selecting the areas where any two adjacent pressure sensors are located as the measurement areas and comparing the FFR values ​​or pressure drop values ​​of non-adjacent measurement areas of the same length; or by selecting the areas where any two non-adjacent pressure sensors are located as the measurement areas and comparing the FFR values ​​or pressure drop values ​​of measurement areas of the same length.

[0119] In some embodiments, determining the critical lesion area based on the comparison result may be determining that the measurement area corresponding to the smallest FFR value among the FFR values ​​is the critical lesion area.

[0120] In some embodiments, determining the key lesion area based on the comparison result may be determining that the measurement area corresponding to the pressure drop value with the largest value among the pressure drop values ​​is the caliber lesion area.

[0121] In some embodiments, the processor may be a central processing unit (CPU), or other general-purpose processors, digital signal processors (DSP), application-specific integrated circuits (ASIC), field-programmable gate arrays (FPGA), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. The general-purpose processor may be a microprocessor or any conventional processor, etc.

[0122] The embodiments of the present application have been described above. The above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, their practical applications, or improvements to the technology in the market, or to enable other persons skilled in the art to understand the embodiments disclosed herein.

Claims

1. A pressure measuring catheter, characterized in that: The device comprises a tube body having an inner cavity and a plurality of pressure sensors, wherein: The tube body includes a distal tube and a proximal tube connected to each other; a mounting groove is provided on the side wall of the distal tube, the number of the mounting grooves being the same as the number of the pressure sensors, and a plurality of the pressure sensors are respectively installed in the corresponding mounting grooves; a plurality of glue injection holes are provided on the wall of the distal tube, communicating with the inner cavity, and the pressure sensors are fixed to the distal tube by adhesive injected through the glue injection holes; The plurality of pressure sensors are located on the same side of the distal tube and are distributed in an array along the axial direction of the distal tube, wherein the area between two pressure sensors is a measurement area.

2. The pressure measuring catheter according to claim 1, wherein: The glue injection hole is arranged adjacent to the mounting groove, and the glue injection hole is communicated with the adjacent mounting groove.

3. The pressure measuring catheter according to claim 1, wherein: The distal tube is a single-tube integrally formed structure or a multi-tube spliced ​​structure, and the distal tube is a constant diameter tube or a variable diameter tube.

4. The pressure measuring catheter according to claim 1, wherein: The tube body is formed integrally of a distal tube and a proximal tube; or The tube body is formed by splicing a distal tube and a proximal tube; Wherein, the tube body is a constant diameter tube or a reducing diameter tube.

5. The pressure measuring catheter according to claim 1, wherein: The distance between two adjacent pressure sensors is 0.5 cm to 10 cm.

6. A pressure measurement system, characterized in that: Comprising the pressure measuring catheter and host according to any one of claims 1 to 5; The pressure measuring catheter is used to collect pressure measurement values ​​in the vascular lesion area; The host is connected to the pressure measuring catheter and is used to obtain pressure measurement values ​​corresponding to the multiple pressure sensors in the pressure measuring catheter, and obtain an FFR value or a pressure drop value based on the pressure measurement values ​​corresponding to two pressure sensors.

7. A system for identifying critical lesion areas, characterized in that: Comprising the pressure measuring catheter and host according to any one of claims 1 to 5; The pressure measuring catheter is used to collect pressure measurement values ​​in the vascular lesion area; The host is connected to the pressure measuring catheter and is used to obtain pressure measurement values ​​corresponding to the plurality of pressure sensors in the pressure measuring catheter, and obtain an FFR value or a pressure drop value based on the pressure measurement values ​​corresponding to two of the pressure sensors; The FFR values ​​or pressure drop values ​​of at least two measurement areas of the same length are compared, and the critical lesion area is determined based on the comparison results.

8. The system for identifying critical lesion areas according to claim 7, characterized in that: The comparing of the FFR values ​​or pressure drop values ​​of at least two measurement areas of the same length includes: The areas where two adjacent pressure sensors are located are selected as measurement areas, and the FFR values ​​or pressure drop values ​​of the adjacent measurement areas having the same length are compared.

9. The system for identifying critical lesion areas according to claim 7 or 8, characterized in that: Determining the key lesion area according to the comparison results includes: Determining that the measurement area corresponding to the FFR value with the smallest numerical value among the FFR values ​​is the critical lesion area; or The measurement area corresponding to the pressure drop value with the largest value among the pressure drop values ​​is determined to be the key lesion area.

10. A computer-readable storage medium, characterized in that A computer program is stored thereon, and when the computer program is executed by the processor, a pressure measurement method is implemented; The pressure measurement method uses the pressure measurement catheter according to any one of claims 1 to 5, comprising: obtaining pressure measurements from a plurality of pressure sensors within the distal tube; An FFR value or a pressure drop value is obtained according to the pressure measurement values ​​corresponding to the two pressure sensors.

11. A computer-readable storage medium, characterized in that A computer program is stored thereon, and when the computer program is executed by a processor, a method for identifying a key lesion area is implemented; The method for identifying a critical lesion area uses the pressure measuring catheter according to any one of claims 1 to 5, comprising: obtaining pressure measurements from a plurality of pressure sensors within the distal tube; Obtaining an FFR value or a pressure drop value according to the pressure measurement values ​​corresponding to the two pressure sensors; Compare the FFR or pressure drop values ​​of at least two measurement areas of equal length; The critical lesion area is determined based on the comparison results.

12. The computer-readable storage medium according to claim 11, wherein The comparing of the FFR values ​​or pressure drop values ​​of at least two measurement areas of the same length includes: The areas where two adjacent pressure sensors are located are selected as measurement areas, and the FFR values ​​or pressure drop values ​​of the adjacent measurement areas having the same length are compared.

13. The computer-readable storage medium according to claim 11 or 12, wherein: Determining the key lesion area according to the comparison results includes: Determining that the measurement area corresponding to the FFR value with the smallest numerical value among the FFR values ​​is the critical lesion area; or The measurement area corresponding to the pressure drop value with the largest value among the pressure drop values ​​is determined to be the key lesion area.

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