Shock wave balloon catheter based on laser excitation
The laser-excited shockwave balloon catheter utilizes a laser receiver and fiber optic layer to generate plasma shockwave energy, solving the problems of permeability and adjustable release direction in existing technologies, and achieving more efficient treatment of intravascular calcified lesions.
Patent Information
- Application Number
- CN202411059209.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-08-03
- Publication Date
- 2026-02-03
AI Technical Summary
Existing shockwave balloon catheters have limitations in terms of permeability and the ability to adjust the direction of shockwave release, making them ineffective in treating intravascular calcification of the tunica media, eccentric calcified nodules, or severe calcified lesions.
The laser-excited shockwave balloon catheter generates plasma shockwave energy through a laser receiver and fiber optic layer. Combined with a contrast tube and a shockwave emission cavity, it achieves better permeability and adjustable shockwave release direction.
It improves the permeability of the shockwave balloon catheter within blood vessels, enabling more precise adjustment of the shockwave release direction, enhancing treatment efficacy, reducing damage to healthy tissues, and ensuring comprehensive treatment of the lesion area.
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Figure CN121445477A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a laser-excited shockwave balloon catheter. Background Technology
[0002] Coronary artery calcification is a very challenging condition to treat with interventional procedures and represents a bottleneck in cardiovascular disease management. Traditional methods for treating calcified plaques include high-pressure balloons, cutting balloons, spinous process balloons, and plaque rotational atherectomy / penetration. However, these instruments each have limitations, and most can only treat superficial intimal calcifications, while remaining ineffective against medial calcifications, eccentric calcified nodules, or severe calcifications.
[0003] With the development of electrohydraulic lithotripsy technology in recent years, shockwave balloon catheters have been gradually applied to the vascular system to treat calcified lesions in blood vessels. However, for high-resistance lesions where instruments are difficult or even impossible to pass through, shockwave balloon catheters based on pulsed high-voltage discharge usually have poor passability due to their large cross-sectional size. In addition, shockwave balloon catheters based on pulsed high-voltage discharge usually need to be implanted in the middle of the calcified lesion to perform targeted treatment on the lesion site, and it is difficult to adjust the release angle and direction of the shockwave. Summary of the Invention
[0004] Therefore, it is necessary to provide a shock wave balloon catheter that has good permeability, is easy to adjust the shock wave release direction, and has a strong shock wave effect.
[0005] The purpose of this invention is to provide a laser-excited shockwave balloon catheter, comprising: The inner tube extends axially from the proximal end to the distal end; A laser receiver has a cylindrical structure and is sealed on the side wall of an inner tube. The proximal end wall of the laser receiver protrudes radially to the outer side of the outer wall of the inner tube. The laser fiber includes a first fiber layer, which includes multiple optical fibers extending axially along the inner tube and uniformly arranged circumferentially on the outer side of the outer wall of the inner tube. The distal end of the first fiber layer is axially aligned with the proximal end wall of the laser receiver. A balloon, which is wrapped around part of the inner tube, and can be filled with a liquid medium; The distal end of the laser fiber and the laser receiver are located inside the balloon. The first laser energy is emitted through the first fiber layer. The first laser energy irradiates the laser receiver, which can induce the laser receiver to generate plasma and form a first shock wave energy. The first shock wave energy can be transmitted outward through the liquid medium inside the balloon.
[0006] Furthermore, the shockwave balloon catheter also includes a contrast tube made of platinum-iridium alloy, coaxially sleeved outside the inner tube and the laser receiver. A shockwave emitting cavity is formed between the contrast tube, the inner tube, and the laser receiver. The shockwave emitting cavity has an inlet located at the proximal end, and the distal end of the laser fiber extends from the inlet into the shockwave emitting cavity. A connecting wall is provided between the contrast tube and the laser receiver. The shockwave emitting cavity also has an opening communicating with the outside, located on the side wall of the contrast tube. The first shockwave energy can be transmitted outward through the opening of the shockwave emitting cavity.
[0007] Furthermore, the radial thickness of the first optical fiber layer is the same as the thickness of the laser receiver protruding to the outer side of the inner tube wall. The laser optical fiber also includes a second optical fiber layer, which includes multiple optical fibers extending axially along the inner tube and uniformly arranged circumferentially outside the first optical fiber layer. The second optical fiber layer can emit second laser energy to the front end of the shock wave balloon catheter. The second laser energy generates an optomechanical effect in the shock wave emission cavity and forms a second shock wave energy. The second shock wave energy can be transmitted outward through the opening of the shock wave emission cavity.
[0008] Furthermore, the distance between the far end of the first optical fiber layer and the near end wall of the laser receiver is 0.5 to 2.0 mm.
[0009] Furthermore, the proximal endwall of the laser receiver has a tapered structure that slopes towards the distal end, with a taper of 15 to 75°.
[0010] Furthermore, the laser receiver is made of an alloy material, such as stainless steel, cobalt-chromium alloy, titanium alloy, nickel-titanium alloy, molybdenum alloy, chromium alloy, vanadium alloy, or tungsten alloy.
[0011] Furthermore, the laser receiver protrudes to the proximal end wall surface of the outer side of the inner tube and has a microporous structure. The surface roughness Ra of the proximal end wall is 0.1 to 0.5 micrometers. The pore size of the micropores ranges from 20 to 80 nanometers, the porosity is 15% to 45%, and the depth of the micropores ranges from 50 to 300 nanometers.
[0012] Furthermore, the laser receiver has a coating / plating layer on the proximal end wall protruding to the outer side of the inner tube. The coating / plating layer has a thickness of 0.1 to 5 micrometers, an absorbance greater than 85%, an adhesion strength greater than 20 MPa, a surface roughness Ra of 0.05 to 0.5 micrometers, and a hardness range of HV 1500 to HV 3000.
[0013] Furthermore, the laser receiver has a chemical modification layer on its proximal endwall. The modification layer contains hydroxyl, amino, or carboxyl groups. The thickness of the modification layer is 0.5 to 3 nanometers, the adhesion strength is greater than 15 MPa, and the surface roughness Ra of the proximal endwall of the modified laser receiver is 0.05 to 0.2 micrometers.
[0014] Furthermore, a physical modification layer is provided on the proximal end wall of the laser receiver. The physical modification layer contains nanoparticles, including gold, silver, palladium, or platinum. The size of the nanoparticles ranges from 10 to 50 nanometers. The adhesion strength of the physical modification layer is greater than 10 MPa. The surface roughness Ra of the proximal end wall of the modified laser receiver is 0.05 to 0.3 micrometers.
[0015] The shockwave balloon catheter provided by this invention, by incorporating a first optical fiber layer and a laser receiver, allows the laser emitted through the first optical fiber layer to irradiate the proximal surface of the laser receiver, resulting in laser-induced optical breakdown and the formation of plasma. Due to the high kinetic energy of the plasma, it diffuses into the surrounding medium, generating the first shockwave energy. Compared to shockwave balloon catheters based on high-voltage pulsed discharge, the shockwave balloon catheter provided by this invention generates shockwave energy through laser excitation, has a smaller radial dimension, and thus better intravascular permeability; furthermore, the release direction and angle of the shockwave can be adjusted by changing the location of the opening and the tilt angle on the sidewall. Attached Figure Description
[0016] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.
[0017] Figure 1 This is a schematic diagram of the shockwave balloon catheter in the first embodiment of the present invention.
[0018] Figure 2 This is a schematic diagram of the internal structure of the shockwave balloon catheter according to the first embodiment of the present invention.
[0019] Figure 3 This is a cross-sectional view of the shock wave balloon catheter along the axis in the first embodiment of the present invention. Detailed Implementation
[0020] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0021] In this instruction manual, the proximal end refers to the end closer to the operator during the procedure, and the distal end refers to the end further away from the operator during the procedure.
[0022] This invention provides a shockwave balloon catheter that utilizes laser-excited shockwave energy to treat intravascular calcified lesions, comprising: The inner tube extends axially from the proximal end to the distal end and has a guidewire lumen for inserting the guidewire. The laser receiver has a cylindrical structure and is sealed on the side wall of the inner tube. The proximal end wall of the laser receiver protrudes radially outward to the outer side of the outer wall of the inner tube. The laser fiber includes a first fiber layer, which includes multiple optical fibers. The multiple optical fibers extend along the axial direction of the inner tube and are uniformly arranged on the outer side of the outer wall of the inner tube in the circumferential direction. The far end of the first fiber layer faces the proximal end wall of the laser receiver along the axial direction. A balloon, which is wrapped around part of the inner tube, can be filled with a liquid medium. The distal end of the laser fiber and the laser receiver are located inside the balloon. The first laser energy is emitted through the first fiber layer. The first laser energy irradiates the laser receiver, which can induce the laser receiver to generate plasma and form a first shock wave energy. The first shock wave energy can be transmitted outward through the liquid medium inside the balloon.
[0023] The shockwave balloon catheter provided by this invention, by incorporating a first optical fiber layer and a laser receiver, allows the laser emitted through the first optical fiber layer to irradiate the proximal surface of the laser receiver, generating free electrons on the receiver surface. The kinetic energy of these free electrons causes a temperature increase, leading to plasma generation. Due to the high kinetic energy of the plasma, it diffuses into the surrounding medium, generating the first shockwave energy. Compared to shockwave balloon catheters based on high-voltage pulsed discharge, the shockwave balloon catheter provided by this invention generates shockwave energy through laser excitation, has a smaller radial dimension, and thus better intravascular permeability. Furthermore, by changing the placement of the opening and the tilt angle on the sidewall, the release angle and direction of the shockwave can be adjusted, thereby adapting to the treatment of calcified lesions in different locations.
[0024] Furthermore, the shockwave balloon catheter also includes a contrast tube made of platinum-iridium alloy, which is coaxially sleeved outside the inner tube and the laser receiver. A shockwave emission cavity is formed between the contrast tube, the inner tube, and the laser receiver. The shockwave emission cavity has an inlet located at the proximal end, and the distal end of the laser fiber extends from the inlet into the shockwave emission cavity. There is a connecting wall between the contrast tube and the laser receiver. The shockwave emission cavity also has an opening communicating with the outside, which is located on the side wall of the contrast tube. The first shockwave energy can be transmitted outward through the opening of the shockwave emission cavity.
[0025] In this invention, the contrast tube can serve as a contrast marker for the distal working area during interventional treatment; furthermore, the shock wave emission cavity formed between the inner wall of the contrast tube, the outer wall of the inner tube, and the laser receiver can converge and guide the energy of the first shock wave, allowing the shock wave energy to be transmitted outward from the opening.
[0026] It should be noted that the inner diameter of the annular structure of the laser receiver matches the outer diameter of the inner tube. The laser receiver is sleeved on the side wall of the inner tube near the far end. The first fiber layer is evenly arranged on the outer side of the outer wall of the inner tube, so that the far end of the first fiber layer is directly opposite the near end wall of the laser receiver.
[0027] Furthermore, the radial thickness of the first fiber layer is the same as the thickness of the laser receiver protruding to the outer side of the inner tube wall. The laser fiber also includes a second fiber layer, which includes multiple optical fibers extending axially along the inner tube and uniformly arranged circumferentially outside the first fiber layer. The second fiber layer can emit second laser energy to the front end of the shock wave balloon catheter. The second laser energy generates an optomechanical effect and forms a second shock wave energy. The second shock wave energy can be transmitted from the opening of the shock wave emission cavity into the balloon and then transmitted outward through the liquid medium inside the balloon.
[0028] It should be noted that the end of the imaging tube and the end of the laser receiver are sealed together by an annular end wall, so that the second laser energy emitted by the second fiber layer is guided to be transmitted outward from the opening, thereby preventing the second laser energy from directly passing through and damaging the balloon.
[0029] This approach combines the energy of a first shock wave generated by laser-induced plasma with the energy of a second shock wave generated by photomechanical effects. This significantly enhances the concentration of energy, allowing the concentrated shock wave energy to be more focused within the target lesion area. The concentrated shock wave energy can more effectively destroy and remove calcified lesions without damaging surrounding healthy tissue. Furthermore, the concentrated shock wave energy has higher penetrating power, enabling it to form a wider shock wave propagation range within the lesion area. The second shock wave energy generated by photomechanical effects can provide a wider coverage area, thereby ensuring that the entire lesion area is effectively treated and reducing treatment blind spots.
[0030] Because the first shock wave energy generated by plasma typically has a relatively high frequency and a short duration, while the second shock wave energy generated by the photomechanical effect has a lower frequency and a longer duration, this invention can achieve effective treatment of the lesion area across multiple frequency bands and time scales by setting the frequency and duration of the first and / or second shock wave energies, further improving the treatment effect. Concentrating the first and second shock wave energies allows for more precise control of the energy distribution and area of effect of the shock waves, avoiding damage to healthy tissue and thus improving the safety of the treatment.
[0031] In this invention, the shock wave emitting cavity can converge and guide the energy of the second shock wave; the first shock wave energy and the second shock wave energy are generated simultaneously in the shock wave emitting cavity, thereby further improving the treatment effect on calcified lesions.
[0032] In this invention, the distance between the distal end of the first fiber layer and the proximal endwall of the laser receiver is 0.5 to 2.0 mm. This is because an excessively long distance between the distal end of the first fiber layer and the proximal endwall of the laser receiver increases light scattering and energy loss, thereby reducing the efficiency of plasma generation; while a distance that is too short can easily lead to localized overheating due to excessive concentration of laser energy. This solution sets the transmission distance within the above-mentioned range, enabling effective transmission before the laser energy attenuates significantly. This ensures that the laser energy emitted from the first fiber layer maintains high transmission efficiency while effectively focusing on the surface of the laser receiver, thereby exciting high-energy plasma. Furthermore, this solution also ensures that the laser energy is uniformly distributed on the surface of the laser receiver, avoiding localized overheating or damage, thereby extending the service life of the laser receiver.
[0033] Furthermore, the proximal end wall of the laser receiver, protruding to the outer side of the inner tube, has a conical structure inclined towards the distal end, with a taper of 15 to 75°. By setting the proximal end wall of the laser receiver as a conical structure, the incident laser energy can be reflected and focused onto the surface of the laser receiver, thereby reducing laser scattering and reflection losses on the surface. The conical structure can also effectively guide the laser energy to a specific focal point, thus better focusing and guiding the laser energy, concentrating more energy in the working area of the laser receiver, and more effectively exciting plasma and generating shock waves, improving the laser energy absorption efficiency and plasma generation efficiency. Secondly, when the laser energy reaches the conical surface, depending on the tilt angle of the conical surface, the energy is guided in a specific direction, and the plasma diffuses in this direction, thereby generating a shock wave with a specific directionality. In addition, the conical structure design can also disperse heat on the surface of the laser receiver, avoiding localized overheating, reducing material damage or fatigue caused by overheating, and improving the durability and service life of the device.
[0034] This solution sets the taper of the proximal end face of the laser receiver within the range of 15 to 75°, which can further optimize the shock wave direction and ensure that the shock wave can act more effectively on the target area. In particular, when treating local calcified lesions, it can improve the focusing effect and treatment efficiency of the shock wave.
[0035] Furthermore, the optical fibers constituting the first and second optical fiber layers are multimode optical fibers. The optical fiber includes a core layer, a cladding layer, and a coating layer that are sequentially covered from the inside out. The core layer material is quartz, and the coating layer material is one or more of acrylate, polyurethane, polyimide, silicone rubber, and fluoropolymer. The outer diameter of the optical fiber is 50 to 500 μm.
[0036] It should be noted that the multiple optical fibers in the first optical fiber layer and the multiple optical fibers in the second optical fiber layer can be arranged in different ways, such as layered arrangement or close arrangement. The first optical fiber layer and the second optical fiber layer can have multiple loops of optical fibers arranged sequentially from the inside to the outside.
[0037] Furthermore, the laser receiver is made of alloy materials, including but not limited to stainless steel, cobalt-chromium alloy, titanium alloy, nickel-titanium alloy, molybdenum alloy, chromium alloy, vanadium alloy, and tungsten alloy.
[0038] Furthermore, the alloy material contains at least one metal selected from titanium, nickel, molybdenum, chromium, vanadium, or tungsten, with the total content of the aforementioned metals ranging from 5% to 30%. Since titanium, nickel, and molybdenum have relatively high absorbance and low reflectance, while chromium, vanadium, and tungsten can further improve the absorbance and thermal conductivity of the material, the addition of these metals to the alloy material enables it to absorb energy more effectively under laser irradiation, thereby significantly increasing the energy of the generated first shock wave.
[0039] In one embodiment of the present invention, the laser receiver protrudes to the surface of the proximal end wall of the inner tube and has a microporous structure. The surface roughness Ra of the proximal end wall is 0.1 to 0.5 micrometers; the micropore diameter ranges from 20 to 80 nanometers; the micropore porosity is 15% to 45%; the micropore depth ranges from 50 to 300 nanometers; and the micropore density is 50 to 200 micropores per square micrometer.
[0040] The aforementioned microporous structure can be fabricated using laser etching, chemical etching, or electrochemical deposition. The surface microporous structure significantly enhances laser energy absorption, thereby increasing plasma generation efficiency and consequently significantly increasing the energy of the generated first shock wave.
[0041] In another embodiment of the present invention, a coating / plating layer is provided on the near end wall of the laser receiver protruding to the outer wall of the inner tube. The coating / plating layer has a thickness of 0.1 to 5 micrometers, an absorbance greater than 85%, an adhesion strength greater than 20 MPa, a surface roughness Ra of 0.05 to 0.5 micrometers, and a hardness range of HV 1500 to HV 3000.
[0042] The types of coatings / platings mentioned above include, but are not limited to, titanium carbide (TiC), titanium nitride (TiN), titanium oxide (TiO2), silicon nitride (SiN), silicon carbide (SiC), and diamond carbon (DLC).
[0043] Methods for forming coatings / platings include chemical vapor deposition and physical vapor deposition. By forming a coating with high light absorption and good adhesion on the metal surface, the absorption of laser light can be significantly enhanced, thereby significantly increasing the energy of the generated first shock wave.
[0044] In another embodiment of the present invention, a chemical modification layer is provided on the near-end wall of the laser receiver. The chemical modification layer contains hydroxyl (–OH), amino (–NH2) or carboxyl (–COOH) groups. The thickness of the chemical modification layer ranges from 0.5 to 3 nanometers. The adhesion strength is greater than 15 MPa. The surface roughness Ra after modification is 0.05 to 0.2 micrometers.
[0045] Since hydroxyl (–OH) modification can increase the absorbance to over 85% and the surface energy to 50 to 70 mJ / m², amino (–NH2) modification can increase the absorbance to over 80% and the surface energy to 45 to 65 mJ / m², and carboxyl (–COOH) modification can increase the absorbance to over 88% and the surface energy to 55 to 75 mJ / m², chemical modification methods can significantly improve the absorbance of metal surfaces, thereby enhancing the absorption efficiency of laser energy, improving the plasma generation effect, and consequently significantly increasing the energy of the first shock wave generated.
[0046] In another embodiment of the present invention, a physical modification layer is provided on the near-end wall of the laser receiver. The physical modification layer is an alloy material modified with nanoparticles. The thickness of the physical modification layer ranges from 50 to 200 nanometers. The nanoparticles include gold (Au), silver (Ag), palladium (Pd), or platinum (Pt), and the size of the nanoparticles ranges from 10 to 50 nanometers. The adhesion strength of the modification layer is greater than 10 MPa, and the surface roughness Ra is 0.05 to 0.3 micrometers. The coverage of the nanoparticles on the physical modification layer is 30% to 70% of the surface area. Since nanoparticles such as gold, silver, palladium, or platinum have excellent optical and electromagnetic properties, modifying the metal surface can enhance the local electromagnetic field, thereby improving the absorption efficiency of laser energy and the generation of plasma.
[0047] Furthermore, the inner tube is made of polymeric materials, including but not limited to one or more of polytetrafluoroethylene, polyetheretherketone, polyethylene, polyurethane, and polyamide.
[0048] In this invention, the opening of the shock wave emission cavity is located on the side wall of the imaging tube, which avoids placing the opening at the front end of the shock wave emission cavity so that the second laser energy acts directly on the balloon wall and damages the balloon.
[0049] In another embodiment of this solution, an annular connecting wall is provided between the developing tube and the outer wall of the laser receiver, and 2 to 6 openings are provided circumferentially at intervals on the side wall of the developing tube, with a total opening area of 0.5 to 2 mm. 2 The opening provided in this design is located on the side wall of the shockwave balloon catheter, which is beneficial for treating calcified lesions on the side wall of blood vessels.
[0050] refer to Figures 1 to 3 The first embodiment of the present invention also provides a laser-excited shockwave balloon catheter 100, comprising: The inner tube 110 extends axially from the proximal end to the distal end and has a guidewire lumen 111 for inserting a guidewire. The laser receiver 120 has a cylindrical structure and is sealed on the side wall near the distal end of the inner tube 110. The proximal end wall of the laser receiver protrudes radially outward to the outer side of the outer wall of the inner tube 110. The developing tube 130, made of platinum-iridium alloy, is coaxially sleeved outside the inner tube 110 and the laser receiver 120. A shock wave emitting cavity is formed between the developing tube 130, the inner tube 110 and the laser emitter 120. The shock wave emitting cavity has an inlet located at the proximal end. The developing tube 130 and the laser receiver 120 are sealed together by an annular connecting wall. The shock wave emitting cavity also has an opening 101 communicating with the outside. The opening 101 is located on the side wall of the developing tube 130. The laser fiber 140 includes a first fiber layer 141 and a second fiber layer 142. Both the first fiber layer 141 and the second fiber layer 142 include multiple optical fibers arranged along the axial direction. The multiple optical fibers of the first fiber layer 141 are evenly arranged circumferentially on the outer wall of the inner tube 110, and the multiple optical fibers of the second fiber layer 142 are evenly arranged circumferentially outside the first fiber layer 141. The balloon 150 is wrapped around the outside of part of the inner tube 110, and the balloon 150 can be filled with a liquid medium. The radial wall thickness of the laser receiver 120 is the same as the radial thickness of the first fiber layer 141, and the distal end of the first fiber layer 141 is directly opposite the proximal end wall of the laser receiver 120. The distal end of the laser fiber 140 and the laser receiver 120 are located inside the balloon 150. The first laser energy is emitted through the first fiber layer 141. The first laser energy irradiates the laser receiver 120, which can induce the laser receiver 120 to generate plasma and form the first shock wave energy. The second laser energy emitted through the second fiber layer 142 forms the second shock wave energy. The first shock wave energy and the second shock wave energy can be transmitted to the balloon 150 through the opening 101 of the shock wave emission cavity, and then transmitted outward through the liquid medium inside the balloon 150.
[0051] In this embodiment, the laser receiver 120 is made of stainless steel, and its near-end wall surface is laser-etched to form a microporous structure with a surface roughness Ra of 0.3 μm; the micropore diameter is 50 nm; the micropore porosity is 30%; the micropore depth range is 50 nm; and the micropore density is 125 per square micrometer.
[0052] In this embodiment, the distance between the far end of the first fiber layer 141 and the near end wall of the laser receiver 120 is 0.5 mm.
[0053] In this embodiment, the laser receiver 120 protrudes to the proximal end wall of the outer wall of the inner tube 110 and has a conical structure that is inclined to the distal end, and the taper of the conical structure is 15°.
[0054] The shockwave balloon catheter 100 provided in this embodiment can be used to treat intravascular calcified lesions. During the treatment process, a guide wire can be first implanted into the designated lesion location, and then the proximal end of the guide wire can be inserted into the guide wire lumen 111 of the inner tube 110, thereby guiding the distal end of the shockwave balloon catheter 100 to be implanted into the lesion site and performing lithotripsy treatment on the lesion site.
[0055] The shockwave balloon catheter 100 provided in this embodiment has a simple structure and a smaller passage size compared with shockwave balloon catheters based on high-voltage pulse discharge, thereby reducing damage to blood vessels and facilitating passage through severe, stenotic lesions.
[0056] In this embodiment, the sidewall of the developing tube 130 is provided with three openings 101 spaced apart circumferentially, with a total opening area of 2 mm². 2 .
[0057] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.
Claims
1. A laser-excited shockwave balloon catheter, characterized in that, include: The inner tube extends axially from the proximal end to the distal end; A laser receiver has a cylindrical structure and is sealed on the side wall of an inner tube. The proximal end wall of the laser receiver protrudes radially to the outer side of the outer wall of the inner tube. The laser fiber includes a first fiber layer, which includes multiple optical fibers extending axially along the inner tube and uniformly arranged circumferentially on the outer side of the outer wall of the inner tube. The distal end of the first fiber layer is axially aligned with the proximal end wall of the laser receiver. A balloon, which is wrapped around part of the inner tube, and can be filled with a liquid medium; The distal end of the laser fiber and the laser receiver are located inside the balloon. The first laser energy is emitted through the first fiber layer. The first laser energy irradiates the laser receiver, which can induce the laser receiver to generate plasma and form a first shock wave energy. The first shock wave energy can be transmitted outward through the liquid medium inside the balloon.
2. The shockwave balloon catheter according to claim 1, characterized in that, The shockwave balloon catheter also includes a contrast tube made of platinum-iridium alloy, which is coaxially sleeved outside the inner tube and the laser receiver. A shockwave emitting cavity is formed between the contrast tube, the inner tube, and the laser receiver. The shockwave emitting cavity has an inlet located at the proximal end, and the distal end of the laser fiber extends from the inlet into the shockwave emitting cavity. A connecting wall is provided between the contrast tube and the laser receiver. The shockwave emitting cavity also has an opening communicating with the outside, which is located on the side wall of the contrast tube. The first shockwave energy can be transmitted outward through the opening of the shockwave emitting cavity.
3. The shockwave balloon catheter according to claim 2, characterized in that, The radial thickness of the first optical fiber layer is the same as the thickness of the laser receiver protruding to the outer side of the inner tube. The laser optical fiber also includes a second optical fiber layer, which includes multiple optical fibers extending axially along the inner tube and uniformly arranged circumferentially outside the first optical fiber layer. The second optical fiber layer can emit second laser energy to the front end of the shock wave balloon catheter. The second laser energy generates an optomechanical effect in the shock wave emission cavity and forms a second shock wave energy. The second shock wave energy can be transmitted outward through the opening of the shock wave emission cavity.
4. The impact balloon catheter according to claim 1, characterized in that, The distance between the far end of the first fiber layer and the near end wall of the laser receiver is 0.5 to 2.0 mm.
5. The shockwave balloon catheter according to claim 1, characterized in that, The laser receiver has a conical structure on its proximal endwall that slopes toward the distal end, with a taper of 15 to 75°.
6. The shockwave balloon catheter according to claim 1, characterized in that, The laser receiver is made of an alloy material, such as stainless steel, cobalt-chromium alloy, titanium alloy, nickel-titanium alloy, molybdenum alloy, chromium alloy, vanadium alloy, or tungsten alloy.
7. The shockwave balloon catheter according to claim 6, characterized in that, The laser receiver protrudes to the proximal end wall surface of the outer side of the inner tube and has a microporous structure. The surface roughness Ra of the proximal end wall is 0.1 to 0.5 micrometers. The pore size of the micropores ranges from 20 to 80 nanometers, the porosity is 15% to 45%, and the depth of the micropores ranges from 50 to 300 nanometers.
8. The shockwave balloon catheter according to claim 6, characterized in that, The laser receiver protrudes to the near-end wall of the inner tube and is coated / plated. The coating / plating has a thickness of 0.1 to 5 micrometers, an absorbance greater than 85%, an adhesion strength greater than 20 MPa, a surface roughness Ra of 0.05 to 0.5 micrometers, and a hardness range of HV 1500 to HV3000.
9. The shockwave balloon catheter according to claim 6, characterized in that, The laser receiver has a chemically modified layer on its proximal endwall. The modified layer contains hydroxyl, amino, or carboxyl groups. The thickness of the modified layer is 0.5 to 3 nanometers, and the adhesion strength is greater than 15 MPa. The surface roughness Ra of the proximal endwall of the modified laser receiver is 0.05 to 0.2 micrometers.
10. The shockwave balloon catheter according to claim 6, characterized in that, The laser receiver has a physical modification layer on its proximal endwall. The physical modification layer contains nanoparticles, including gold, silver, palladium, or platinum. The size of the nanoparticles ranges from 10 to 50 nanometers. The adhesion strength of the physical modification layer is greater than 10 MPa. The surface roughness Ra of the proximal endwall of the modified laser receiver is 0.05 to 0.3 micrometers.