Acoustic energy wire system and energy wire

Abstract

This invention relates to an acoustic energy guidewire system and an energy guidewire, the energy guidewire comprising a pushing section and a developing section. The first end of the pushing section is connected to a main unit or handle, and the pushing section is made of metal. The developing section includes a mandrel and a covering layer disposed outside the mandrel. One of the mandrel and the covering layer is integrally formed with its second end, while the other is made of a metallic developing material. The elastic modulus of the pushing section is greater than that of the developing section. During operation, the developing section, driven by the pushing section, enters the lesion site and applies its energy to the lesion site, thereby achieving a therapeutic effect. Because one of the mandrel and the covering layer is integrally formed with the second end and the pushing section, the continuous, weld-free, integrated structure reduces stress concentration points in the overall mechanical structure of the product. This prevents rapid failure at stress concentration points, ensuring the energy guidewire can safely and stably transmit mechanical acoustic energy.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an acoustic energy guidewire system and an energy guidewire. Background Technology

[0002] There are many types of chronic total occlusion (CTO) lesions. This article will focus on CTO lesions as a specific example, as it is one of the most challenging aspects of interventional treatment. Pathological and imaging studies confirm that most CTO lesions have anterograde or retrograde collateral circulation, maintaining a certain blood supply to the distal segment of the occluded vessel. However, even with adequate collateral circulation, functionally it is only equivalent to the blood supply of 90% of the stenotic vessel, barely enough to maintain myocardial viability at rest and blood supply to dormant myocardium. When myocardial oxygen consumption increases, patients experience symptoms of myocardial ischemia such as angina and decreased exercise tolerance. Successfully opening a CTO lesion can alleviate angina symptoms, improve left ventricular function, stabilize myocardial electrical activity, and thus enhance the patient's tolerance to future coronary events. CTO lesions account for approximately 30% of all coronary lesions. Compared to general complex lesions, CTO lesion surgery has a low success rate and a high complication rate. How to improve the success rate of interventional treatment for CTO lesions is a question that has been a focus of attention and discussion.

[0003] With improvements in interventional devices, accumulated experience, and new understanding of CTO lesion theory, the success rate of CTO has improved in recent years, with many large international interventional centers achieving a success rate of over 90%. However, the overall success rate still needs further improvement. Analysis of factors contributing to CTO failure shows that guidewire inaccessibility (63%-92%) is the most common, including failure to penetrate the proximal / distal fibrous cap of the occlusion, entry into the false lumen, or perforation. Balloon inaccessibility is the second most common (10%), followed by failure to dilate the lesion (5%). Therefore, successful recanalization of CTO lesions is inseparable from the successful selection and application of the guidewire. Furthermore, endovascular recanalization of CTO generally involves long operation times, large amounts of contrast agent, and high X-ray exposure, potentially increasing the risk of complications such as contrast-induced nephropathy, radiation-induced skin damage, and cerebral hemorrhage. It also has adverse effects on the health of operators who perform long-term endovascular recanalization of CTO lesions. Therefore, it is necessary to shorten operation time and reduce contrast agent usage and X-ray exposure through technological improvements.

[0004] Traditionally, the use of active energy sources such as shock waves and ultrasound to assist guidewire passage has become increasingly sophisticated. Common techniques for opening CTO lesions include antegrade and retrograde guidewire recanalization. Anterior guidewire recanalization is generally preferred due to its relative safety, while retrograde guidewire recanalization is only used as a secondary option after antegrade recanalization failure because it involves longer procedures, greater radiation exposure, more contrast agent use, and a higher risk of complications. However, current guidewires are designed with materials and structures that achieve a small diameter and a rigid distal end to pass through severely calcified CTO lesions with hardened fibrous caps. This requires highly skilled operators, and current guidewires are not suitable for interventional treatment of completely occluded lesions caused by various chronic diseases. Summary of the Invention

[0005] This invention provides an acoustic energy guide wire system and an energy guide wire to solve one or more technical problems in the prior art.

[0006] The technical solution is as follows: an energy guidewire, the energy guidewire comprising:

[0007] A push segment, comprising a first end and a second end opposite to each other, the first end for connecting to a host or controller, the push segment being made of metal; and

[0008] The developing section includes a mandrel and a covering layer connected to the outside of the mandrel. One of the mandrel and the covering layer is integrally formed with the second end, and the other is made of a metal developing material. The elastic modulus of the pushing section is greater than that of the developing section.

[0009] In one embodiment, the metal developing material includes one or more of gold, platinum, tungsten, iridium, osmium, rhenium, palladium, tantalum, platinum alloy, platinum-tungsten alloy, platinum-iridium alloy, and platinum-nickel alloy; and / or, the material of the push segment is selected from nickel-titanium alloy, nickel-titanium based alloy, iron-based alloy, stainless steel, or cobalt-based alloy.

[0010] In one embodiment, the mandrel and the push section are an integrated structure, and the coating layer is made of a metal developing material and is disposed on the outside of the mandrel by electroplating or physical vapor deposition.

[0011] In one embodiment, the mandrel includes a variable diameter section and a straight section, with the opposite ends of the variable diameter section connected to the second end of the push section and the straight section, respectively; the outer diameter of the variable diameter section decreases in a direction away from the push section.

[0012] In one embodiment, the angle between the outer wall surface of the variable diameter section and its central axis is α, where α is 15° to 40°.

[0013] In one embodiment, a spiral structure is formed on the outer wall of the coating layer.

[0014] In one embodiment, one or more protrusions are provided on the outer wall of the end of the mandrel away from the pushing section, the protrusions being circumferentially arranged around one end of the mandrel; a plurality of the protrusions are arranged sequentially at intervals along the extension direction of the mandrel.

[0015] In one embodiment, the gap between two adjacent protrusions is 0.8 mm to 1.2 mm.

[0016] In one embodiment, the energy guidewire further includes a connecting segment; one end of the connecting segment is provided with an interface for connecting to a host or handle, and the other end of the connecting segment is used to connect to the first end of the push segment.

[0017] In one embodiment, the diameter of the connecting segment decreases in the direction close to the pushing segment; and / or, one end face of the connecting segment close to the pushing segment is provided with an insertion hole, and the outer wall surface of the connecting segment is provided with an injection hole that connects the insertion hole to the outside of the connecting segment, and the first end of the pushing segment is inserted into the insertion hole and bonded to the connecting segment.

[0018] In one embodiment, the length of the developing section is 6cm to 40cm; the diameter of the developing section is 0.2mm to 0.8mm; and the diameter of the developing section is less than or equal to the diameter of the pushing section.

[0019] An acoustic energy guide wire system, the acoustic energy guide wire system includes the energy guide wire and a host, the host being connected to the first end.

[0020] In one embodiment, the acoustic guide wire system further includes a handle disposed between the main unit and the first end, the main unit being connected to the handle via a wire, and the handle being connected to the first end.

[0021] In the aforementioned acoustic energy guidewire system and energy guidewire, during operation, the imaging segment, driven by the pushing segment, enters the lesion site and applies energy from the pushing segment to the lesion site, thereby achieving a therapeutic effect. Since one of the mandrel and the covering layer is connected to the second end and integrated with the pushing segment, this continuous, weld-free, integrated structure reduces stress concentration points in the overall mechanical structure of the product. This prevents rapid failure at stress concentration points, ensuring the energy guidewire can safely and stably transmit mechanical acoustic energy. Furthermore, unlike traditional techniques that reduce the diameter of the distal region of the energy guidewire (i.e., the part of the energy guidewire furthest from the handle) to assist in entering tortuous lesions, thus avoiding the adverse phenomenon of blood vessel puncture, the energy guidewire in this embodiment relatively improves surgical safety. In addition, the imaging segment uses a metallic imaging material with good flexibility, allowing the elastic modulus of the pushing segment to be less than that of the imaging segment, which facilitates the imaging segment reaching the tortuous lesion site and thus achieving a better therapeutic effect. Furthermore, the metallic imaging material has good X-ray opacity, helping the surgeon to accurately position the energy guidewire during surgery. Secondly, the density of radiopaque metallic materials is relatively high, so compared with traditional energy wires of the same volume size, energy wires are heavier in the distal region. Consequently, for the same wave source, the amplitude of the longitudinal wave will decrease after reaching the distal region, which helps the energy wire to operate stably. Attached Figure Description

[0022] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an improper limitation of the invention.

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the structure of an acoustic energy guide wire system according to an embodiment of this application;

[0025] Figure 2 This is a schematic diagram of the structure of an energy guide wire according to an embodiment of this application;

[0026] Figure 3 This is a schematic diagram of the structure of the energy guide wire according to another embodiment of this application;

[0027] Figure 4 This is a schematic diagram of the structure of an energy guide wire according to another embodiment of this application;

[0028] Figure 5This is a schematic diagram of the structure of the energy guide wire according to another embodiment of this application;

[0029] Figure 6 for Figure 5 A magnified structural diagram at point A;

[0030] Figure 7 This is a schematic diagram of the connection segment and the pushing segment of the energy guide wire according to an embodiment of this application;

[0031] Figure 8 This is a schematic diagram of the structure of the developing section of the energy guidewire in an embodiment of this application when the developing section is arranged concentrically.

[0032] Figure 9 This is a schematic diagram of the structure of the imaging section of the energy guidewire in an embodiment of this application when it is arranged in an off-center manner.

[0033] 10. Energy guide wire; 11. Pushing section; 12. Developing section; 121. Mandrel; 1211. Variable diameter section; 1212. Straight section; 1213. Protrusion; 1214. Gap; 122. Coating layer; 1221. Helical structure; 123. Through hole; 13. Connecting section; 131. Interface; 132. Insertion hole; 133. Glue injection hole; 20. Main unit; 30. Handle; 40. Wire. Detailed Implementation

[0034] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0035] As described in the background section, the existing technology has high operational requirements, and the current guidewires cannot meet the needs of interventional treatment for various chronic diseases with complete occlusion. The inventors have found that the reasons for this problem are: 1. Energy cannot be effectively transmitted along the guidewire; 2. Severe breakage occurs in the guidewire solder joint area.

[0036] For the reasons mentioned above, this invention provides an acoustic guidewire system and an energy guidewire, which have the ability to quickly penetrate various chronic diseases and completely occlude lesions, thereby greatly improving the success rate of surgery, reducing the operation time and providing better treatment results for patients, while also benefiting the health of the surgeon.

[0037] See Figure 1 and Figure 2 , Figure 1 A schematic diagram of the structure of an acoustic energy guide wire system according to an embodiment of this application is shown. Figure 2A schematic diagram of the structure of an energy guidewire 10 according to an embodiment of this application is shown. An embodiment of the present invention provides an energy guidewire 10, which includes a pushing section 11 and a developing section 12. The pushing section 11 includes a first end and a second end opposite to each other. The first end is used to connect to a host 20 or a handle 30. The pushing section 11 is made of a metal material. The developing section 12 includes a mandrel 121 and a covering layer 122 connected to the outside of the mandrel 121. One of the mandrel 121 and the covering layer 122 is connected to the second end and is integrally formed with the pushing section 11; the other is made of a metal developing material. The elastic modulus of the pushing section 11 is greater than that of the developing section 12.

[0038] It should be noted that the integrated structure of one of the mandrel 121 and the covering layer 122 with the second end means that one of the mandrel 121 and the covering layer 122 is, for example, a structure formed by extending the second end along the axial direction of the pushing section 11. In other words, one of the mandrel 121 and the covering layer 122 and the pushing section 11 are specifically manufactured as a single piece of the same metal material.

[0039] Optionally, please refer to Figure 2 When the mandrel 121 is connected to the second end and is integrated with the push section 11, during the production of the energy guide wire 10, for example, the push section 11 and the mandrel 121 can be integrally formed by forging, casting, or other methods. Alternatively, a first semi-finished product including the push section 11 can be processed first, that is, the first semi-finished product can be processed according to the diameter of the push section 11. Then, the front part of the first semi-finished product can be ground to obtain the mandrel 121. Then, the coating layer 122 is connected to the outside of the mandrel 121 by methods including but not limited to electroplating, physical vapor deposition (PVD), etc.

[0040] Optionally, please refer to Figure 3 , Figure 3 The diagram illustrates the structure of the energy guide wire 10 according to another embodiment of this application. When the coating layer 122 and the mandrel 121 are an integrated structure, during manufacturing, for example, a second semi-finished product including a pusher section 11 can be processed first, that is, a second semi-finished product can be processed according to the diameter of the pusher section 11. Then, a through hole 123 is formed by drilling from the end face of the front section of the second semi-finished product. Then, the metal developing material is injected into the through hole 123 as the mandrel 121. In this way, the metal developing material is located inside the through hole 123, and the material of the coating layer 122 is the same as the material of the pusher section 11. Using a material that is harder than the metal developing material results in better wear resistance and makes it less prone to damage.

[0041] It should be noted that, generally speaking, when an external force is applied to an elastic body, the elastic body will undergo a change in shape (called "deformation"). The general definition of "elastic modulus" is: stress under uniaxial stress state divided by strain in that direction.

[0042] In operation, the aforementioned energy guidewire 10 has its imaging segment 12 driven by the pushing segment 11 to reach the lesion site, delivering energy from the pushing segment 11 to the lesion site for therapeutic effect. Since one of the mandrel 121 and the covering layer 122 is connected to the second end and integrated with the pushing segment 11, the continuous, weld-free integrated structure reduces stress concentration points in the overall mechanical structure of the product. This prevents rapid failure at stress concentration points, ensuring the energy guidewire 10 can safely and stably transmit mechanical energy. Furthermore, unlike conventional techniques that reduce the diameter of the distal region of the energy guidewire 10 (i.e., the part of the energy guidewire 10 furthest from the handle 30) to facilitate entry into tortuous lesions, thus avoiding the adverse phenomenon of blood vessel puncture, the energy guidewire 10 in this embodiment relatively improves surgical safety. In addition, the imaging segment 12 uses a metallic imaging material with good flexibility, allowing the elastic modulus of the pushing segment 11 to be less than that of the imaging segment 12, which facilitates the imaging segment 12 reaching the tortuous lesion site and achieving a better therapeutic effect. In addition, the radiopaque metallic material has good X-ray opacity, which helps the surgeon to accurately locate the energy guidewire 10 during the operation. Secondly, the radiopaque metallic material has a relatively high density, so compared with the traditional energy guidewire 10 of the same volume size, the energy guidewire 10 is heavier in the distal region. Consequently, for the same wave source, the amplitude of the longitudinal wave will be reduced after it reaches the distal region, which helps the energy guidewire 10 to operate stably.

[0043] In one embodiment, the metallic imaging material includes, but is not limited to, one or more of gold, platinum, tungsten, iridium, osmium, rhenium, palladium, tantalum, platinum alloys, platinum-tungsten alloys, platinum-iridium alloys, and platinum-nickel alloys. And / or, optionally, the material of the push segment 11 includes, but is not limited to, nickel-titanium alloys, nickel-titanium-based alloys, iron-based alloys, stainless steel, or cobalt-based alloys. Thus, based on the material selection of the push segment 11, the elastic modulus of the push segment 11 can be greater than that of the imaging segment 12. The imaging segment 12, due to its relatively lower elastic modulus, exhibits better flexibility, facilitating its insertion into tortuous lesions. The push segment 11, due to its relatively higher elastic modulus, is less prone to bending and knotting during catheter delivery, achieving stable delivery of the imaging segment 12.

[0044] It should be noted that nickel-titanium based alloys refer to binary nickel-rich nickel-titanium based alloys with appropriately reduced Ni or Ti content and the addition of certain alloying elements such as Al, Nb, Hf, Ta, Zr, Mo, and Co. While maintaining the various properties of nickel-rich nickel-titanium based alloys, these alloys improve hardness, high-temperature stability, wear resistance, and corrosion resistance. Alternatively, certain alloying elements such as V, Cu, Hf, Fe, and Cr can be added to improve the toughness of the nickel-titanium based alloy, thereby improving the alloy's machinability.

[0045] It should be noted that iron-based alloys include, but are not limited to, iron-nickel alloys, iron-titanium alloys, etc. Furthermore, cobalt-based alloys include, but are not limited to, cobalt-chromium alloys, cobalt-nickel alloys, etc.

[0046] In one specific embodiment, the mandrel 121 and the push section 11 are an integrated structure. The covering layer 122 is made of a metallic radiopaque material and is disposed on the outside of the mandrel 121 by electroplating or physical vapor deposition. Thus, compared to placing the metallic radiopaque material inside the through-hole 123, using a metallic radiopaque material for the covering layer 122 not only reduces manufacturing difficulty but also provides a larger radiopaque area with good X-ray opacity, helping the surgeon to accurately position the energy guidewire 10 during surgery.

[0047] Please see Figures 2 to 5 In any one embodiment, in order to ensure that the push segment 11 is stably delivered inside the catheter and avoids bending and knotting, while ensuring the flexibility of the imaging segment 12 so that it can pass smoothly through tortuous lesions, in this embodiment, the diameter of the push segment 11 is larger than that of the mandrel 121.

[0048] Furthermore, as an example, the diameter of the pushing segment 11 is the same as or substantially the same as the diameter of the imaging segment 12. "Substantially the same" means that the diameter of the imaging segment 12 is not mathematically identical to the diameter of the pushing segment 11, but can deviate within an acceptable range, such as up to 10%. In this way, the imaging segment 12, while ensuring its flexibility to pass through tortuous lesions, is large enough to avoid the adverse phenomenon of puncturing blood vessels, thus improving safety.

[0049] Please see Figures 2 to 5 In any given example, the diameter of the push segment 11 remains constant or substantially constant from front to back. This facilitates the integral machining of the push segment 11. "Substantially constant" means that the diameter of the push segment 11 is not mathematically absolutely constant from front to back, but rather can have a deviation within an acceptable range, such as less than 10%. Of course, as some optional solutions, the push segment 11 can also be designed as multiple parts, each with a slightly different diameter. The specific design can be flexibly adjusted and selected according to actual needs, and is not limited here.

[0050] Please see Figures 2 to 5 In any given embodiment, the push segment 11 is, for example, a solid structure, which facilitates manufacturing and provides a relatively high elastic modulus. Of course, the push segment 11 can also be designed as a hollow structure.

[0051] Please see Figure 2 In one embodiment, the mandrel 121 includes a variable-diameter section 1211 and a straight section 1212. The opposite ends of the variable-diameter section 1211 are respectively connected to the second end of the push section 11 and the straight section 1212. The outer diameter of the variable-diameter section 1211 decreases in a direction away from the push section 11. Specifically, the variable-diameter section 1211 may be, but is not limited to, cone-shaped, with one end having the same diameter as the second end and the other end having the same diameter as the straight section 1212. Thus, since the diameter of the second end of the push section 11 is larger than that of the straight section 1212, the transition from the variable-diameter section 1211 to the straight section 1212 via the decreasing diameter helps to efficiently conduct sound energy and reduce local stress concentration.

[0052] Please see Figure 2 In one embodiment, the outer wall surface of the variable diameter section 1211 is aligned with its central axis (e.g., Figure 2 The included angle formed by the dashed line O in the diagram is α, where α is not limited to, but can range from 15° to 40°. Therefore, setting the included angle α within this range is beneficial for efficient sound energy transmission and reduces local stress concentration.

[0053] Specifically, 'a' can be, for example, 20°, 22°, 24°, 25°, 27°, or 30°. In this embodiment, 'a' is 25°.

[0054] Of course, as some alternatives, 'a' can also be designed as any value from 0° to 15° or from 40° to 90°.

[0055] Please see Figure 4 , Figure 4 A schematic diagram of the energy guide wire 10 according to another embodiment of this application is shown. In yet another embodiment, a helical structure 1221 is formed on the outer wall of the coating layer 122. Thus, by adding the helical structure 1221 to disrupt the continuous structure of each side surface of the coating layer 122, the tensile stress on the bending convex surface during material bending can be released, and the gap provides sufficient space to release the compressive stress on the inner surface of the material, thereby further improving the flexibility of the developing section 12. Alternatively, the helical structure 1221 can be formed by metal processing using tools such as a lathe. Optionally, the helical structure 1221 is a helical groove wound around the outer wall of the coating layer 122.

[0056] Please see Figure 5and Figure 6 , Figure 5 A schematic diagram of the structure of the energy guide wire 10 according to another embodiment of this application is shown. Figure 6 It shows Figure 5 An enlarged structural schematic diagram at point A. In one embodiment, one or more protrusions 1213 are provided on the outer wall of the end of the mandrel 121 away from the push section 11, and the protrusions 1213 are arranged circumferentially around one end of the mandrel 121. Multiple protrusions 1213 are arranged sequentially at intervals along the extension direction of the mandrel 121. Thus, each protrusion 1213 is equivalent to an amplification point, which has better mechanical transmission. However, because the location of the protrusions 1213 occupies space, metal developing material cannot be placed, resulting in a weakened developing effect. Furthermore, it helps to increase the contrast of local developing, thereby improving the performance of the energy guidewire 10. Additionally, when multiple amplification points are provided on the outer wall of one end of the developing section 12, a gap 1214 (e.g., ...) is formed between two adjacent protrusions 1213. Figure 6 As indicated by arrow m in the diagram, the gap 1214 is filled with metallic developing material to improve the developing effect.

[0057] Please see Figure 6 In one embodiment, the protrusion 1213 and the mandrel 121 are an integral structure, that is, the protrusion 1213 and the mandrel 121 are made of the same material and are integrally formed.

[0058] It should be noted that the outer wall of the end of the mandrel 121 may have one, two, three, four, or other numbers of protrusions 1213. The specific number is not limited here and can be flexibly adjusted and set according to actual needs. Among them, when there is only one protrusion 1213, the mechanical amplification effect is the best; when there is more than one protrusion 1213, it can help doctors measure the depth of the lesion and speed up the treatment process.

[0059] Please see Figure 6 In one embodiment, the gap 1214 between two adjacent protrusions 1213 (e.g.) Figure 6 The size (as indicated by arrow m) is 0.8mm-1.2mm. Specifically, the gap 1214 between two adjacent protrusions 1213 is set to 0.8mm, 0.9mm, 1mm, 1.1mm, 1.2mm, etc. In this embodiment, the gap 1214 is preferably set to 1mm, which can help doctors measure the depth of the lesion and make the measurement more intuitive.

[0060] Please see Figure 7 , Figure 7The diagram illustrates the structure of the connecting segment 13 and the pushing segment 11 of the energy guide wire 10 according to an embodiment of this application. In one embodiment, the energy guide wire 10 further includes the connecting segment 13. One end of the connecting segment 13 is provided with an interface 131 for connecting to the host 20 or the handle 30, and the other end of the connecting segment 13 is used to connect to the first end of the pushing segment 11.

[0061] Please see Figure 7 In one embodiment, the connection method between interface 131 and host 20 or handle 30 includes, but is not limited to, bonding, mechanical fitting, threaded assembly, etc., and is not limited here. It can be flexibly adjusted and set according to actual needs.

[0062] Please see Figure 7 In one embodiment, in order to ensure the sound energy transmission effect, the connecting segment 13 is made of metal, preferably the same material as the pushing segment 11.

[0063] Please see Figure 7 In one embodiment, the diameter of the connecting segment 13 decreases in the direction approaching the pushing segment 11. And / or, one end face of the connecting segment 13 near the pushing segment 11 is provided with an insertion hole 132, and the outer wall surface of the connecting segment 13 is provided with an injection hole 133 connecting the insertion hole 132 to the outside of the connecting segment 13. The first end of the pushing segment 11 is inserted into the insertion hole 132 and bonded to the connecting segment 13. Thus, during the assembly of the first end of the pushing segment 11 and the connecting segment 13, the first end is first inserted into the insertion hole 132, and then glue is injected through the injection hole 133, thereby achieving a secure connection and assembly between the first end and the pushing segment 11.

[0064] Please see Figure 7 In one embodiment, the connecting segment 13 is designed as part of the handle 30 or the main unit 20 and assembled together with it. That is, the connecting segment 13 is designed as part of the handle 30 or the main unit 20, so the interface 131 can be omitted and it can be directly integrated with the handle 30 or the main unit 20.

[0065] It should be noted that the length of the push segment 11 typically constitutes the majority of the effective length of the energy guidewire 10, while the imaging segment 12 is only located at the distal end of the energy guidewire 10. The length of the imaging segment 12, representing the length at which the product may enter tortuous lesions, ranges from approximately 6cm to 40cm, with 10cm being preferred. The effective length of the energy guidewire 10 is determined based on the application scenario, and the length of the push segment 11 is naturally derived from the difference between the effective length and the length of the imaging segment 12. The effective length of the energy guidewire 10 is flexibly set and selected according to the usage scenario and is not limited here. For example, for coronary artery products, the effective length of the energy guidewire 10 is typically 1.2m to 1.8m; for peripheral products, the effective length is typically 1.2m to 3m.

[0066] Please see Figure 8 and Figure 9 , Figure 8 This diagram illustrates the structure of the developing section 12 of the energy guidewire 10 according to an embodiment of this application, when they are arranged concentrically. Figure 9 This illustration shows a schematic diagram of the structure of the developing section 12 of the energy guidewire 10 in an eccentric arrangement according to an embodiment of this application. In one embodiment, the cladding layer 122 and the mandrel 121 can be arranged concentrically, i.e., as shown in the diagram. Figure 8 As shown; of course, the cladding layer 122 and the mandrel 121 can also be arranged eccentrically, also known as heterocentrically, i.e., as shown Figure 9 As shown.

[0067] Optionally, please refer to Figure 9 When the cladding layer 122 and the straight section 1212 of the mandrel 121 are arranged eccentrically, the mandrel 121 is not located at the center of the energy guide wire 10. Due to the significant difference in density between the two materials, the overall center of gravity of the product will be offset from the geometric center of the outer contour to a certain extent; this solution can reduce the interference of longitudinal waves on the operation of the energy guide wire 10. During the transmission of longitudinal waves, the geometric center of the energy guide wire 10 in the direction of wave vibration is not the center of gravity, so additional inelastic energy dissipation is generated during sinusoidal oscillation, thereby reducing the overall impact of longitudinal vibration.

[0068] Extensive research has revealed that for the energy guide wire 10, where the mandrel 121 and the push section 11 are integrated, the bending strength of the developing section 12 changes accordingly when the ratio of the diameter D1 of the mandrel 121 to the diameter D2 of the developing section 12 changes. In order to maintain the bending strength of the energy guide wire 10 with different specifications of developing sections 12 at an adjustable level, the bending strength required for different applications can be calculated based on the formula table of bending stiffness and experimental results.

[0069] The following table provides a formula for bending stiffness, showing the relationship between the bending stiffness and diameter ratio for two different specifications of energy guide wire 10:

[0070] Formula for bending stiffness

[0071]

[0072] Note: The values ​​for energy conductor 10 in the table correspond to the following material combinations: mandrel 121 - nickel-titanium alloy (1:1), cladding layer 122 - pure gold. And the following methods are used... Figure 8 The concentric structure is shown. Furthermore, the percentages in the table represent the ratio of the mandrel 121 diameter to the developing section 12 diameter, i.e., D1 / D2; for non-concentric structures, please refer to [reference needed]. Figure 9 D1 and D2 have the same meaning, but their specific outer diameter ratios differ. For non-concentric designs, a design with a lower percentage (smaller percentage) can be used.

[0073] Bending stiffness is expressed as: K = EI, where K is the bending stiffness (unit: Pa*m^4), representing the degree to which the device is easily bent, E (unit: Pa) is the bending elastic modulus of the material (since metals are usually polycrystalline and therefore do not have anisotropy, the elastic modulus of normal stress can be used instead for calculation), and I is the moment of inertia of the cross section (unit: m^4), which is determined by the cross-sectional shape of the device, such as the change in the outer diameter of the guide wire product;

[0074] The current horizontal classification of bending stiffness in design includes:

[0075] High: Not suitable for tortuous lesions and coronary vessels, but suitable for peripheral vessels above the knee. It has strong pushing performance and the highest sound wave transmission efficiency.

[0076] Middle: Suitable for non-torsional coronary artery lesions, or the sub-knee segment of peripheral vessels;

[0077] Low: Suitable for lesions in conventional coronary arteries or those with moderate coronary artery tortuosity.

[0078] Please refer to the following: Figure 1 and Figure 2 In one embodiment, an acoustic energy guidewire system includes an energy guidewire 10 as described in any of the above embodiments, and a host unit 20 connected to the first end. The energy guidewire 10 is used to transmit acoustic energy along the treatment pathway for therapeutic purposes. The host unit 20 supplies power to the entire acoustic energy guidewire system. Optionally, the host unit 20 also provides a human-machine interface and treatment parameter settings.

[0079] In the aforementioned acoustic energy guidewire system, during operation, the imaging segment 12, driven by the pushing segment 11, enters the lesion site and applies energy from the pushing segment 11 to the lesion site, thereby achieving a therapeutic effect. Since one of the mandrel 121 and the covering layer 122 is connected to the second end and integrated with the pushing segment 11, the continuous, weld-free integrated structure reduces stress concentration points in the overall mechanical structure of the product. This prevents rapid failure at stress concentration points, ensuring the safe and stable transmission of mechanical acoustic energy by the energy guidewire 10. Furthermore, unlike conventional techniques that reduce the diameter of the distal region of the energy guidewire 10 (i.e., the part of the energy guidewire 10 furthest from the handle 30) to assist in entering tortuous lesions, thus avoiding the adverse phenomenon of blood vessel puncture, the energy guidewire 10 in this embodiment relatively improves surgical safety. In addition, the imaging segment 12 uses a metallic imaging material with good flexibility, allowing the elastic modulus of the pushing segment 11 to be less than that of the imaging segment 12, which facilitates the imaging segment 12 reaching the tortuous lesion site, thereby achieving a better therapeutic effect. In addition, the radiopaque metallic material has good X-ray opacity, which helps the surgeon to accurately locate the energy guidewire 10 during the operation. Secondly, the radiopaque metallic material has a relatively high density, so compared with the traditional energy guidewire 10 of the same volume size, the energy guidewire 10 is heavier in the distal region. Consequently, for the same wave source, the amplitude of the longitudinal wave will be reduced after it reaches the distal region, which helps the energy guidewire 10 to operate stably.

[0080] In one embodiment, the acoustic guidewire system further includes a handle 30 disposed between the main unit 20 and the first end. The main unit 20 is connected to the handle 30 via a wire 40, and the handle 30 is connected to the first end. The handle 30 is used to improve the overall operability of the device; the wire 40 is used to connect the energy and signal pathways between the handle 30 and the main unit 20, enabling the handle 30 and the main unit 20 to be connected without distance limitations, thus greatly improving operability.

[0081] In some embodiments, the handle 30 and the wire 40 can be omitted; in other words, optionally, the main unit 20 is directly connected to the energy guide wire 10. Accordingly, the effective length of the energy guide wire 10 can be increased to ensure operability. In addition, the operation control functions on the original handle 30 are transferred to the main unit 20 and implemented through the main unit 20.

[0082] In some embodiments, this type of acoustic energy guide wire system has an internal energy conversion component. Common principle classifications include: hydraulic-electric, piezoelectric, electromagnetic, holmium laser, and pneumatic impact. The energy conversion component is usually located inside the handle 30 or the main unit 20. When the acoustic energy guide wire system also has a handle 30, the transducer will be located inside the handle 30; when the acoustic energy guide wire system omits the handle 30, the transducer will be installed inside the main unit 20. Regardless of the design, the energy guide wire 10 will be directly (possibly connected by an amplifying rod, latch, or other rigid connection) connected to the acoustic energy output section of the transducer.

[0083] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0084] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

[0085] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0086] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0087] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

Claims

1. An energy guidewire, characterized in that, The energy guidewire includes: The push segment includes a first end and a second end opposite to each other, the first end being used to connect to the host or the controller, and the push segment being made of metal material; The developing section includes a mandrel and a covering layer connected to the outside of the mandrel. One of the mandrel and the covering layer is a continuous, weld-free, integral structure with the second end, while the other is made of a metallic developing material. The elastic modulus of the pushing section is greater than that of the developing section. A connecting segment has an interface at one end for connecting to a host or handle, and the other end for connecting to the first end of the push segment. The diameter of the connecting segment decreases towards the push segment. An insertion hole is provided at one end of the connecting segment near the push segment, and an injection hole is provided on the outer wall of the connecting segment connecting the insertion hole to the outside of the connecting segment. The first end of the push segment is inserted into the insertion hole and bonded to the connecting segment with adhesive. The diameter of the developing segment is equal to the diameter of the push segment.

2. The energy guidewire according to claim 1, characterized in that, The metal developing material includes one or more of gold, platinum, tungsten, iridium, osmium, rhenium, palladium, tantalum, platinum alloy, platinum-tungsten alloy, platinum-iridium alloy, and platinum-nickel alloy; and / or, the material of the pushing segment is selected from nickel-titanium alloy, iron-based alloy, or cobalt-based alloy.

3. The energy guidewire according to claim 1, characterized in that, The mandrel and the push section are an integrated structure. The coating layer is made of metal developing material and is applied to the outside of the mandrel by electroplating or physical vapor deposition.

4. The energy guidewire according to claim 3, characterized in that, The mandrel includes a variable diameter section and a straight section. The two opposite ends of the variable diameter section are respectively connected to the second end of the push section and the straight section. The outer diameter of the variable diameter section decreases in a direction away from the push section.

5. The energy guidewire according to claim 4, characterized in that, The angle between the outer wall surface of the variable diameter section and its central axis is α, where α is 15°~40°.

6. The energy guidewire according to claim 3, characterized in that, A spiral structure is formed on the outer wall of the coating layer.

7. The energy guidewire according to claim 3, characterized in that, One or more protrusions are provided on the outer wall of the end of the mandrel away from the pushing section, and the protrusions are arranged circumferentially around one end of the mandrel; a plurality of the protrusions are arranged at intervals along the extension direction of the mandrel.

8. The energy guidewire according to claim 7, characterized in that, The gap between two adjacent protrusions is 0.8mm to 1.2mm.

9. The energy guidewire according to claim 1, characterized in that, The length of the developing section is 6cm to 40cm; the diameter of the developing section is 0.2mm to 0.8mm.

10. An acoustic energy guide wire system, characterized in that, The acoustic energy guide wire system includes an energy guide wire as described in any one of claims 1 to 9, and further includes a host unit connected to the first end.

11. The acoustic energy guide wire system according to claim 10, characterized in that, The acoustic energy guide wire system also includes a handle disposed between the main unit and the first end. The main unit is connected to the handle via a wire, and the handle is connected to the first end.

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