Drug coating balloon with real-time pressure monitoring function

Abstract

The invention relates to the technical field of interventional medical instruments, in particular to a drug coating balloon with a real-time pressure monitoring function, a full balloon surface of the drug coating balloon is formed by compounding a high-molecular polymer matrix and a piezoelectric material layer, the piezoelectric material layer is processed by a polarization process, and the polarization direction of the piezoelectric material layer is perpendicular to the full balloon surface. A micron-sized groove array is arranged on the surface of the filling balloon, a guide wire path, a filling path and a signal transmission path which are mutually independent are arranged in the catheter, one end of the signal transmission path is connected with the micron-sized groove array, and the other end of the signal transmission path is connected with the display terminal. In-situ sensing is realized by utilizing a piezoelectric material, and the adherence pressure can be monitored in real time in the balloon filling and dilating process, so that the problem that a drug coating cannot be efficiently adhered to a blood vessel wall due to insufficient dilating pressure is effectively avoided, and meanwhile, blood vessel injury caused by overlarge dilating pressure is prevented.

Description

Technical Field

[0001] This application relates to the field of interventional medical device technology, and in particular to a drug-coated balloon with real-time pressure monitoring function. Background Technology

[0002] Drug-coated balloons (DCBs) are key devices in interventional therapy. With balloon inflation, the anti-proliferative drug on their surface is rapidly released to the vessel wall, significantly inhibiting intimal hyperplasia. However, current clinical applications of DCBs have a significant drawback: during the balloon inflation phase, the operator cannot directly and in real-time obtain the actual contact pressure between the balloon and the vessel wall; they can only indirectly judge the DCB's adhesion to the vessel wall by observing changes in the balloon's shape using X-ray angiography.

[0003] This indirect assessment method raises two issues: First, two-dimensional images cannot accurately represent the actual contact state in three-dimensional space, which can easily lead to incomplete local drug adhesion or excessive balloon expansion, thereby affecting drug delivery efficiency or causing vascular damage. Second, the radiation generated by repeated angiography increases the medical risks for both doctors and patients. Although intravascular ultrasound (IVUS) and optical coherence tomography (OCT) can assist in assessment, they require additional equipment, significantly increasing the complexity and cost of the procedure and negatively impacting patient prognosis. Summary of the Invention

[0004] To address the aforementioned technical issues—namely, the difficulty in accurately representing the actual contact state in three-dimensional space using two-dimensional imaging, which can lead to incomplete local drug adhesion or excessive balloon expansion, thereby affecting drug delivery efficiency or causing vascular damage; and the increased radiation from repeated angiography raising medical risks for both doctors and patients. Although intravascular ultrasound (IVUS) and optical coherence tomography (OCT) can assist in assessment, they require additional equipment, significantly increasing surgical complexity and cost, and negatively impacting patient prognosis—this application provides a drug-coated balloon with real-time pressure monitoring capabilities, the technical solution of which is as follows.

[0005] A drug-coated balloon with real-time pressure monitoring function has an inflatable balloon surface composed of a polymer matrix and a piezoelectric material layer. The piezoelectric material layer is treated with a polarization process, and the polarization direction of the piezoelectric material layer is perpendicular to the surface of the inflatable balloon. The surface of the inflatable balloon is provided with a micron-level groove array. The catheter has independent guidewire paths, inflation paths, and signal transmission paths. One end of the signal transmission path is connected to the micron-level groove array, and the other end of the signal transmission path is connected to a display terminal. The piezoelectric material layer withstands pressure and generates an electrical signal; The signal transmission path delivers the electrical signal to the display terminal, which then converts the electrical signal into a three-dimensional pressure distribution surface for display.

[0006] Optionally, the catheter, from distal to proximal, comprises: a balloon segment, wherein the inflation balloon is located in the balloon segment; a catheter tip, wherein the catheter tip includes an independent guidewire lumen, an inflation lumen, and a signal transmission lumen; a catheter stem, wherein the catheter stem includes an independent inflation channel and a signal transmission channel, the inflation channel communicating with the inflation lumen, and one end of the signal transmission channel being connected to the micron-level groove array via the signal transmission lumen; and a catheter hub, wherein the catheter hub includes an inflation interface and a signal transmission interface, the inflation interface communicating with the inflation channel, and the signal transmission interface being connected to the other end of the signal transmission channel; the signal transmission channel transmits the electrical signal to the signal transmission interface, the signal transmission path including the signal transmission channel and the signal transmission interface, the guidewire path including the guidewire lumen, and the inflation path including the inflation lumen, the inflation channel, and the inflation interface.

[0007] Optionally, the display terminal includes a filtering module, an analog-to-digital converter module, and a pressure distribution cloud map module. The signal transmission interface sends the electrical signal to the filtering module to eliminate electrical signal interference. The filtering module sends the electrical signal to the analog-to-digital converter module to convert the electrical signal into a digital signal. The analog-to-digital converter module sends the digital signal to the pressure distribution cloud map module to fit the digital signal into a continuous three-dimensional pressure distribution surface for display.

[0008] Optionally, the surface of the balloon segment is coated with a drug coating.

[0009] Optionally, the catheter rod further includes a guidewire channel that communicates with the guidewire lumen.

[0010] Optionally, the catheter hub may further include a guidewire interface, which communicates with the guidewire channel.

[0011] Optionally, the signal transmission channel is a shielded coaxial cable.

[0012] Optionally, the filling interface and the guide wire interface are standard Luer connectors, the signal transmission interface uses a waterproof miniature connector, and the surface of the catheter seat is provided with anti-slip texture.

[0013] Optionally, a storage module may also be included, which records pressure monitoring data and supports data export via a USB interface or wireless communication module.

[0014] Optionally, the piezoelectric material in the piezoelectric material layer includes one or more of the following: polyvinylidene fluoride and its copolymers, potassium sodium niobate, quartz, potassium sodium tartrate, lithium niobate, lithium tantalate, lithium gallium oxide, bismuth germanate, barium titanate, sodium bismuth titanate, barium strontium niobate, aromatic polyurea, polypeptide polymer, liquid crystal polymer, zinc oxide, aluminum nitride, and gallium nitride.

[0015] Compared with the prior art, the technical solution of this application has the following advantages: by using piezoelectric materials to achieve in-situ sensing, the wall pressure can be monitored in real time during the balloon inflation and expansion process, thereby effectively avoiding the inability of the drug coating to adhere efficiently to the blood vessel wall due to insufficient expansion pressure, and preventing vascular damage caused by excessive expansion pressure. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the overall structure of a drug-coated balloon with real-time pressure monitoring function according to this patent. Figure 2 This is a partial enlarged view of the balloon segment of a drug-coated balloon with real-time pressure monitoring function according to this patent. Figure 3 This is a partial enlarged view of the tip of a drug-coated balloon catheter with real-time pressure monitoring function according to this patent. Figure 4 This is a partially enlarged view of the drug-coated balloon catheter rod and catheter seat with real-time pressure monitoring function, as described in this patent. In the diagram: 1. Balloon segment; 2. Drug coating; 3. Catheter tip; 31. Guidewire lumen; 32. Filling lumen; 33. Signal transmission lumen; 4. Catheter rod; 41. Filling channel; 42. Signal transmission channel; 43. Guidewire channel; 5. Catheter hub; 51. Filling interface; 52. Signal transmission interface; 53. Guidewire interface; 6. Display terminal. Detailed Implementation

[0017] To facilitate understanding and implementation of this application by those skilled in the art, the patent will be further described in detail below with reference to the accompanying drawings and specific embodiments. The following embodiments are used to illustrate the patent, but it should be understood that the scope of protection of the patent is not limited by the specific embodiments.

[0018] This application provides a drug-coated balloon with real-time pressure monitoring function, such as... Figures 1 to 4 As shown, the surface of its inflatable balloon is composed of a polymer matrix and a piezoelectric material layer. The piezoelectric material layer is treated with a polarization process, and the polarization direction of the piezoelectric material layer is perpendicular to the surface of the inflatable balloon. The surface of the inflatable balloon is provided with a micron-level groove array. The catheter is provided with independent guidewire paths, inflatable paths and signal transmission paths. One end of the signal transmission path is connected to the micron-level groove array, and the other end of the signal transmission path is connected to the display terminal. When the piezoelectric material layer is subjected to pressure, it generates an electrical signal. The signal transmission path delivers the electrical signal to the display terminal, which then converts the electrical signal into a three-dimensional pressure distribution surface for display.

[0019] The term "inflatable balloon" does not refer to a balloon in a fully inflated state, but rather to a balloon that can be inflated.

[0020] One end of the signal transmission path is connected to a micron-level groove array to realize the transmission of electrical signals on the surface of the balloon.

[0021] Among them, the polarization process makes the charge output of the piezoelectric layer linearly positively correlated with the contact pressure of the blood vessel wall, thereby converting the external pressure into an electrical signal in real time.

[0022] In some embodiments, the catheter comprises, from distal to proximal,: a balloon segment, wherein an inflatable balloon is located in the balloon segment; a catheter tip, wherein the catheter tip includes an independent guidewire lumen, an inflatable lumen, and a signal transmission lumen; a catheter stem, wherein the catheter stem includes an independent inflatable channel and a signal transmission channel, the inflatable channel communicating with the inflatable lumen, and one end of the signal transmission channel being connected to a micron-scale groove array via the signal transmission lumen; and a catheter hub, wherein the catheter hub includes an inflatable interface and a signal transmission interface, the inflatable interface communicating with the inflatable channel, and the signal transmission interface being connected to the other end of the signal transmission channel; the signal transmission channel transmits an electrical signal to the signal transmission interface, the signal transmission path includes the signal transmission channel and the signal transmission interface, the guidewire path includes the guidewire lumen, and the inflatable path includes the inflatable lumen, the inflatable channel, and the inflatable interface.

[0023] In some embodiments, the display terminal includes a filtering module, an analog-to-digital conversion module, and a pressure distribution cloud map module. The signal transmission interface sends electrical signals to the filtering module to eliminate electrical signal interference. The filtering module sends the electrical signals to the analog-to-digital conversion module to convert the electrical signals into digital signals. The analog-to-digital conversion module sends the digital signals to the pressure distribution cloud map module to fit the digital signals into a continuous three-dimensional pressure distribution surface for display.

[0024] Among them, the filtering module is used to eliminate electrical signal interference, the analog-to-digital conversion module realizes signal digitization, and the pressure distribution cloud map module uses algorithms to fit discrete pressure point data into a continuous three-dimensional pressure distribution surface, so as to realize the visualization and dynamic monitoring of pressure data.

[0025] The integrated design of the dual-lumen catheter rod ensures flexibility while supporting single-person operation, significantly reducing the time for guidewire exchange and balloon positioning.

[0026] This technical solution solves the problem that traditional drug-coated balloons cannot monitor vascular contact pressure in real time, significantly improving the accuracy and safety of treatment.

[0027] First, the balloon adopts a composite structure of polymer and piezoelectric material. Through polarization process, the piezoelectric layer can directly convert external pressure into electrical signal. Combined with the signal transmission channel composed of independent wires, dynamic detection of blood vessel wall contact pressure can be achieved without damaging the integrity of the drug coating, avoiding the coating damage caused by traditional external sensors.

[0028] Secondly, the display terminal has a built-in filtering module to eliminate electromagnetic noise and motion artifacts. Through analog-to-digital conversion and algorithm processing, it generates a three-dimensional pressure distribution cloud map, allowing the operator to adjust the filling pressure or balloon position in real time, improving the uniformity of drug release and reducing the probability of vascular injury.

[0029] In some embodiments, the surface of the balloon segment is coated with a drug coating.

[0030] The drug coating does not contain piezoelectric materials.

[0031] In some embodiments, the catheter rod further includes a guidewire channel that communicates with the guidewire lumen.

[0032] In some embodiments, the catheter hub further includes a guidewire interface that communicates with a guidewire channel.

[0033] Among them, the three-lumen integrated catheter rod structure provides excellent pushability and maneuverability, making it suitable for interventional procedures with complex anatomical pathways or those requiring stronger support.

[0034] In some embodiments, the signal transmission channel is a shielded coaxial cable.

[0035] The mutual shielding is achieved by covering each conductor with a metal foil shielding layer and an insulating sheath, and filling the spaces between adjacent conductors with insulating material, in order to suppress electromagnetic interference and improve the accuracy of pressure signal transmission.

[0036] In some embodiments, the filling interface and guide wire interface are standard Luer connectors, the signal transmission interface uses a waterproof miniature connector, and the surface of the catheter seat is provided with anti-slip texture.

[0037] In some embodiments, a storage module is also included, which records pressure monitoring data and supports data export via a USB interface or a wireless communication module.

[0038] In some embodiments, the piezoelectric material in the piezoelectric material layer includes one or more of polyvinylidene fluoride and its copolymers, sodium potassium niobate, quartz, sodium potassium tartrate, lithium niobate, lithium tantalate, lithium gallium oxide, bismuth germanate, barium titanate, sodium bismuth titanate, barium strontium niobate, aromatic polyurea, polypeptide polymer, liquid crystal polymer, zinc oxide, aluminum nitride, and gallium nitride.

[0039] For example, in a drug-coated balloon with real-time pressure monitoring, the balloon is made of a mixture of a high molecular weight polymer (including polyamide and polyether block polyamide) and a piezoelectric material (including polyvinylidene fluoride and its copolymers, and potassium sodium niobate) in a certain ratio (1:5 to 5:1), and the mixture is hot-melt extruded to obtain a balloon tube. The piezoelectric composite balloon tube is then hot-blown to obtain a balloon segment with piezoelectric properties. The obtained balloon segment is placed in a DC electric field (10 to 30 kV / mm) with a certain field strength for polarization treatment, and kept at a certain temperature (50 to 80 °C) and for a certain time (1 to 5 h) to make the polarization direction of the piezoelectric material layer perpendicular to the balloon surface.

[0040] Several micron-sized (1 to 10 μm) grooves are pre-processed in the piezoelectric material layer of the balloon segment. Medical-grade conductive materials (including polypyrrole and polyaniline) are filled in the grooves. The distal wire of the signal transmission channel is inserted into the piezoelectric groove filled with medical-grade conductive material after the insulation is stripped off, or the distal wire is welded to the piezoelectric groove filled with medical-grade conductive material using a femtosecond laser. The connection between the wire and the piezoelectric layer of the balloon is covered with medical-grade insulating material (including polyimide) to effectively prevent liquid from seeping in and causing short circuits when the balloon is inflated.

[0041] The catheter tip includes independently designed guidewire, filling, and signal transmission lumens. The catheter shaft employs a multi-lumen integrated design, integrating the filling channel, signal transmission channel, and guidewire lumen separately depending on the catheter type. These three channels are physically isolated to prevent interference between fluid and electrical signals, while flexible polymer materials ensure catheter delivery performance in tortuous blood vessels. The signal interface connects quickly to the display terminal via a standardized plug, eliminating the need for additional wiring during the procedure.

[0042] The terminal features a built-in filtering module (cutoff frequency 10 to 50 Hz) to eliminate catheter motion artifacts and environmental electromagnetic interference; a high-precision analog-to-digital conversion module digitizes analog signals at a sampling rate of 150 to 200 Hz; and a pressure distribution cloud map module generates a three-dimensional dynamic cloud map based on a finite element interpolation algorithm, with a resolution of 0.01 to 0.1 mm², using red-blue gradient chromatography to mark the 50 to 200 kPa pressure range. The terminal is equipped with a touchscreen, allowing operators to zoom in and out of the cloud map in real time, mark risk areas, and export pressure data, improving drug adhesion uniformity by 30% to 60%.

Claims

1. A drug-coated balloon with real-time pressure monitoring function, characterized in that, The surface of the inflatable balloon is composed of a polymer matrix and a piezoelectric material layer. The piezoelectric material layer is treated with a polarization process, and the polarization direction of the piezoelectric material layer is perpendicular to the surface of the inflatable balloon. The surface of the inflatable balloon is provided with a micron-level groove array. The catheter is provided with independent guidewire paths, inflatable paths and signal transmission paths. One end of the signal transmission path is connected to the micron-level groove array, and the other end of the signal transmission path is connected to the display terminal (6). The piezoelectric material layer withstands pressure and generates an electrical signal; The signal transmission path transmits the electrical signal to the display terminal (6), and the display terminal (6) converts the electrical signal into a three-dimensional pressure distribution surface for display.

2. A drug-coated balloon with real-time pressure monitoring function according to claim 1, characterized in that, The catheter, from distal to proximal, comprises: a balloon segment (1), wherein the inflation balloon is located in the balloon segment (1); a catheter tip (3), wherein the catheter tip (3) includes an independent guidewire lumen (31), an inflation lumen (32), and a signal transmission lumen (33); a catheter rod (4), wherein the catheter rod (4) includes an independent inflation channel (41) and a signal transmission channel (42), wherein the inflation channel (41) is connected to the inflation lumen (32), and one end of the signal transmission channel (42) is connected to the micron-level groove array via the signal transmission lumen (33); and a catheter seat (5). The device includes a filling interface (51) and a signal transmission interface (52). The filling interface (51) is connected to the filling channel (41), and the signal transmission interface (52) is connected to the other end of the signal transmission channel (42). The signal transmission channel (42) transmits the electrical signal to the signal transmission interface (52). The signal transmission path includes the signal transmission channel (42) and the signal transmission interface (52). The guide wire path includes the guide wire cavity (31). The filling path includes the filling cavity (32), the filling channel (41), and the filling interface (51).

3. A drug-coated balloon with real-time pressure monitoring function according to claim 2, characterized in that, The display terminal (6) includes a filtering module, an analog-to-digital conversion module, and a pressure distribution cloud map module. The signal transmission interface (52) transmits the electrical signal to the filtering module to eliminate electrical signal interference. The filtering module transmits the electrical signal to the analog-to-digital conversion module to convert the electrical signal into a digital signal. The analog-to-digital conversion module transmits the digital signal to the pressure distribution cloud map module to fit the digital signal into a continuous three-dimensional pressure distribution surface for display.

4. A drug-coated balloon with real-time pressure monitoring function according to claim 3, characterized in that, The surface of the balloon segment (1) is coated with a drug coating (2).

5. A drug-coated balloon with real-time pressure monitoring function according to claim 3, characterized in that, The catheter rod (4) also includes a guidewire channel (43), which connects to the guidewire lumen.

6. A drug-coated balloon with real-time pressure monitoring function according to claim 5, characterized in that, The catheter hub (5) also includes a guidewire interface (53), which is connected to the guidewire channel (43).

7. A drug-coated balloon with real-time pressure monitoring function according to claim 1, characterized in that, The signal transmission channel (42) is a mutually shielded coaxial cable.

8. A drug-coated balloon with real-time pressure monitoring function according to claim 4, characterized in that, The filling interface (51) and the guide wire interface (53) are standard Luer connectors, the signal transmission interface (52) uses a waterproof miniature connector, and the surface of the catheter seat (5) is provided with anti-slip texture.

9. A drug-coated balloon with real-time pressure monitoring function according to claim 1, characterized in that, It also includes a storage module that records pressure monitoring data and supports data export via a USB interface or wireless communication module.

10. A drug-coated balloon with real-time pressure monitoring function according to claim 1, characterized in that, The piezoelectric material in the piezoelectric material layer includes one or more of the following: polyvinylidene fluoride and its copolymers, potassium sodium niobate, quartz, potassium sodium tartrate, lithium niobate, lithium tantalate, lithium gallium oxide, bismuth germanate, barium titanate, sodium bismuth titanate, barium strontium niobate, aromatic polyurea, polypeptide polymer, liquid crystal polymer, zinc oxide, aluminum nitride, and gallium nitride.

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