An OCT imaging catheter, imaging probe and manufacturing method thereof

Abstract

The present invention discloses an OCT imaging catheter, an imaging probe, and a manufacturing method thereof, and relates to the technical field of medical devices. The imaging probe includes an optical fiber and a reflective lens, wherein the reflective lens is provided at the distal end of the optical fiber, and the reflective lens has a reflective surface and a light-emitting surface; in the radial direction of the imaging probe, the projection of the reflective surface is an arc, and the tangent plane of the reflective surface intersects with the center line of the optical fiber and forms an angle with the opening facing the distal end of the optical fiber and the non-light-emitting side, and the angle is an acute angle. The present invention improves the imaging probe structure of the OCT imaging catheter, and adopts a curved conical lens to achieve efficient focusing of the light beam, which can form a fine light spot, reduce astigmatism, and improve imaging quality. This structure is convenient for miniaturization, flexible bending, and improves the spatial resolution of the probe.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an OCT imaging catheter, an imaging probe, and a method for manufacturing the same. Background Technology

[0002] Because OCT (Optical Coherence Tomography) imaging technology acquires relatively clear images, allowing for complete and clear observation of the target area, it has become a mainstream method for vascular imaging. Currently, OCT imaging catheters are widely used in coronary arteries, intracranial vessels, and other fields.

[0003] However, due to the thinness and complexity of intracranial blood vessels, when performing intracranial vascular imaging, the optical fiber is prone to attenuation due to light loss and scattering during the transmission process as the OCT imaging catheter travels through the many bends, thinness and complexity of intracranial blood vessels, resulting in poor image quality. Summary of the Invention

[0004] The main objective of this invention is to provide an OCT imaging catheter, an imaging probe, and a method for manufacturing the same, with the aim of improving imaging quality.

[0005] To achieve the above objectives, the present invention provides an imaging probe, comprising:

[0006] Fiber optics; and

[0007] A reflecting lens is disposed at the distal end of the optical fiber. The reflecting lens has a reflecting surface and a light-emitting surface. In the radial direction of the imaging probe, the projection of the reflecting surface is arc-shaped. The tangent of the reflecting surface intersects the centerline of the optical fiber and forms an angle with the opening facing the distal end of the optical fiber and not on the side of the light-emitting surface. The angle is acute.

[0008] Optionally, in the radial direction of the imaging probe, the projection of the light-emitting surface and the projection of the optical fiber are on the same straight line.

[0009] Optionally, the projection of the light-emitting surface in the radial direction of the imaging probe is an arc, and the cross-section of the light-emitting surface is parallel to the centerline of the optical fiber.

[0010] Optionally, the imaging probe further includes a focusing lens disposed between the distal end of the optical fiber and the reflecting lens, the focusing lens being used to focus light onto the reflecting surface of the reflecting lens.

[0011] Optionally, in the radial direction of the imaging probe, the light-emitting surface and the reflecting surface are symmetrically arranged about the centerline of the optical fiber.

[0012] Optionally, the outer periphery of the optical fiber and the reflective lens connected to its end is covered with a gradient strain layer and a protective layer from the inside out. The gradient strain layer is used to reduce stress concentration, and the protective layer is used to enhance flexibility and protect the optical fiber and the reflective lens.

[0013] Optionally, the imaging probe further includes a coreless optical fiber located between the optical fiber and the reflecting lens, the coreless optical fiber being used to expand the beam of light emitted by the optical fiber.

[0014] Optionally, the imaging probe further includes a coreless optical fiber located between the optical fiber and the focusing lens, the coreless optical fiber being used to expand the beam of light emitted by the optical fiber.

[0015] To achieve the above objectives, the present invention proposes a method for manufacturing an imaging probe, which includes the following steps:

[0016] The end face of the optical fiber is silanized.

[0017] A conical reflective lens with a total internal reflection surface is 3D printed on the end face of the optical fiber.

[0018] The reflective lens is developed using a developing agent to target the time.

[0019] The reflective lens is rinsed and then cured to obtain the imaging probe.

[0020] To achieve the above objectives, the present invention also proposes an OCT imaging catheter, comprising:

[0021] The catheter body has an inner lumen, and an imaging window is provided at the distal end of the catheter body; and

[0022] An imaging probe, movably inserted into the cavity and extending to the imaging window; the imaging probe includes:

[0023] Fiber optics; and

[0024] A reflecting lens is disposed at the distal end of the optical fiber. The reflecting lens has a reflecting surface and a light-emitting surface. In the radial direction of the imaging probe, the projection of the reflecting surface is arc-shaped. The tangent of the reflecting surface intersects the centerline of the optical fiber and forms an angle with the opening facing the distal end of the optical fiber and not on the side of the light-emitting surface. The angle is acute.

[0025] In the technical solution of this invention, the imaging probe includes an optical fiber and a reflecting lens. The reflecting lens is located at the distal end of the optical fiber and has a reflecting surface and a light-emitting surface. In the radial direction of the imaging probe, the projection of the reflecting surface is arc-shaped. The tangent of the reflecting surface intersects the centerline of the optical fiber, forming an acute angle with the opening facing the distal end of the optical fiber towards the non-light-emitting surface. It can be understood that this invention improves the imaging probe structure of the OCT imaging catheter by using a curved conical lens, achieving efficient beam focusing, forming a fine light spot, reducing astigmatism, and improving imaging quality. Furthermore, this structure facilitates miniaturization, is flexible in bending, and improves the spatial resolution of the probe. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the structure of an embodiment of the imaging probe of the present invention;

[0028] Figure 2 for Figure 1 A schematic diagram showing the angle formed between the cross-section of the intermediate reflection lens and the centerline of the optical fiber;

[0029] Figure 3 This is a schematic diagram of another embodiment of the imaging probe of the present invention;

[0030] Figure 4 This is a schematic diagram of another embodiment of the imaging probe of the present invention;

[0031] Figure 5 This is a schematic diagram of another embodiment of the imaging probe of the present invention;

[0032] Figure 6 This is a schematic diagram of another embodiment of the imaging probe of the present invention;

[0033] Figure 7 This is a schematic diagram of the structure of one embodiment of the imaging probe of the present invention;

[0034] Figure 8 This is a schematic diagram of the structure of an embodiment of the OCT imaging catheter of the present invention;

[0035] Figure 9 for Figure 8 Enlarged view of section A in the middle;

[0036] Figure 10 for Figure 8Enlarged view of section B in the middle;

[0037] Figure 11 This is a schematic diagram of the proximal outer tube in one embodiment of the OCT imaging catheter of the present invention;

[0038] Figure 12 This is a schematic diagram showing the connection between the proximal and distal outer tubes in one embodiment of the OCT imaging catheter of the present invention;

[0039] Figure 13 This is a schematic diagram of the spring tube and a cross-sectional view of the spring tube at the imaging ring in one embodiment of the OCT imaging catheter of the present invention;

[0040] Figure 14 This is a schematic flowchart of an embodiment of the manufacturing method of the imaging probe of the present invention.

[0041] Explanation of icon numbers:

[0042] 10. Conduit body; 20. Imaging probe; 10a. Filling space; 101. Outer tube; 102. Guide wire tip; 103. Spring tube; 104. Imaging ring; 201. Optical fiber; 202. Reflecting lens; 203. Focusing lens; 204. Coreless optical fiber; 111. Proximal outer tube; 112. Distal outer tube; 1111. Inner layer; 1112. Middle layer; 1113. Outer layer; 1131. Recessed section; 1132. Mating section; 30. Protective cover; 40. Connector; 50. Stress buffer tube; 60. Connector sleeve; 71. Pull-back mark; 72. Lens mark; 73. Axis mark strip; 221. Reflecting surface; 222. Light emitting surface; 2031. Gradient strain layer; 2032. Protective layer.

[0043] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0044] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0045] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indication will also change accordingly.

[0046] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0047] Furthermore, the use of terms such as "first" and "second" in this invention is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. The word "and / or" throughout the text means including three parallel solutions; for example, "A and / or B" includes solution A, solution B, or a solution that simultaneously satisfies A and B. The technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0048] This invention proposes an imaging probe applicable to fields such as coronary arteries and intracranial vessels, but not limited thereto.

[0049] Reference Figures 1 to 6 , Figure 9 In some embodiments of the present invention, the imaging probe 20 includes an optical fiber 201 and a reflecting lens 202. The reflecting lens 202 is disposed at the distal end of the optical fiber 201 and has a reflecting surface 221 and a light-emitting surface 222. In the radial direction of the imaging probe 20, the projection of the reflecting surface 221 is arc-shaped, and the tangent of the reflecting surface 221 intersects the centerline of the optical fiber 201 and forms an angle α with the opening facing the distal end of the optical fiber 201 and on the side not facing the light-emitting surface 222. The angle α is an acute angle.

[0050] In this embodiment, the optical fiber 201 can be a single-mode optical fiber 201 (SMF) or the like. The included angle α is preferably 45°, but is not limited here.

[0051] The mirror can be manufactured with high precision using 3D printing technology, and can also be designed with free-form surfaces, optimized materials, miniaturized and integrated, as well as customized designs, which is conducive to achieving high-resolution, large-depth-of-field imaging.

[0052] It is understood that this invention improves the structure of the imaging probe 20 of the OCT imaging catheter by employing a curved conical reflective lens 202, which achieves efficient beam focusing, forms a fine light spot, reduces astigmatism, and improves imaging quality. Furthermore, this structure facilitates miniaturization, is flexible in bending, and improves the spatial resolution of the probe.

[0053] Main reference Figure 1 and Figure 2 In one embodiment, the projection of the light-emitting surface 222 is flush with the projection of the optical fiber 201 in the radial direction of the imaging probe 20, meaning that their projection lines are on the same straight line. This facilitates manufacturing and saves costs.

[0054] Main reference Figure 3 In another embodiment, the projection of the light-emitting surface 222 in the radial direction of the imaging probe 20 can also be an arc, and the cross-section of the light-emitting surface 222 is parallel to the centerline of the optical fiber 201. This arrangement can further focus the light beam and further improve the imaging quality of the imaging probe 20.

[0055] Main reference Figure 4 In one embodiment, the imaging probe 20 may further include a focusing lens 203, which is disposed between the distal end of the optical fiber 201 and the reflecting lens 202. The focusing lens 203 is used to focus light onto the reflecting surface 221 of the reflecting lens 202. In the radial direction of the imaging probe 20, the light-emitting surface 222 and the reflecting surface 221 are symmetrically arranged about the centerline of the optical fiber 201. The focusing lens 203 has a focusing surface, and in the radial direction of the imaging probe 20, the projection of the focusing surface is an arc with its center located on one side of the reflecting lens 202.

[0056] In this embodiment, in order to reduce the diameter of the optical fiber 201 and avoid the imaging probe 20 from breaking, a focusing lens 203 is provided on the basis of the aforementioned double-arc reflective lens 202 to focus the light beam onto the reflective surface 221 of the reflective lens 202, ensuring that the diameter of the lens and the optical fiber 201 remain unchanged. The conical reflective lens 202 consists of two symmetrical arc surfaces.

[0057] In addition, a multi-layer structure can be provided on the reflective lens 202 to protect it, such as covering the crystal head.

[0058] Main reference Figure 5 and Figure 6 In some other embodiments, the imaging probe 20 may also include a coreless fiber 204 located between the single-mode fiber 201 and the reflecting lens 202, the coreless fiber 204 being used to expand the beam of light emitted by the single-mode fiber 201.

[0059] This embodiment includes at least the following three technical solutions:

[0060] Option 1, such as Figure 5 As shown, the projection of the light-emitting surface 222 is aligned with the single-mode fiber 201 and the coreless fiber 204, i.e., flush.

[0061] Option 2, such as Figure 6 As shown, the projection of the light-emitting surface 222 can be an arc, and the cross-section of the light-emitting surface 222 is parallel to the center line of the optical fiber 201.

[0062] Option 3, based on the aforementioned option with focusing lens 203, refers to... Figure 4 Furthermore, a coreless fiber 204 can be provided between the single-mode fiber 201 of the imaging probe 20 and the focusing lens 203. Figure 4 (not shown), which can further improve image quality.

[0063] In this embodiment, by adding a coreless fiber 204, the beam of the single-mode fiber 201 is expanded, and the light emitted from the core of the single-mode fiber 201 is expanded to a certain extent. This guides the beam and reduces light loss and scattering during transmission, thereby improving imaging resolution.

[0064] To reduce stress concentration in optical fiber 201, and to minimize the impact of fiber 201 bending on light transmission while ensuring the overall flexibility of the imaging probe 20, the following references were made: Figure 7 In one embodiment, the optical fiber 201 is a single-mode optical fiber 201. The outer periphery of the single-mode optical fiber 201 and the reflective lens 202 connected to its end is covered with a gradient strain layer 2031 and a protective layer 2032 from the inside to the outside. The gradient strain layer 2031 is used to reduce stress concentration, and the protective layer 2032 is used to enhance the flexibility of the single-mode optical fiber 201 and the reflective lens 202 and protect the single-mode optical fiber 201 and the reflective lens 202.

[0065] In this embodiment, the optical fiber 201 of the imaging probe 20 adopts a novel gradient strain structure, dividing the optical fiber 201 into three layers from the inside out: 1) The inner layer is a traditional single-mode optical fiber 201 structure with a diameter of about 9 μm; 2) The middle layer is a gradient strain layer 2031 with a thickness of about 20-30 μm, which can be made of a special elastic polymer material, whose Young's modulus gradually decreases from the inside out to form a stress gradient; 3) The outer layer is a protective layer 2032, which can be made of a soft polymer material.

[0066] In other words, in this embodiment, the optical fiber 201, based on the conventional single-mode optical fiber 201, has two structural layers covering its outer periphery and the distal reflecting lens 202: a gradient strain layer 2031 in the middle and an outermost protective layer 2032. In this invention, the two structural layers are not limited to covering the single-mode optical fiber 201, the reflecting lens 202, the focusing lens 203, the coreless optical fiber 204, or other imaging probes.

[0067] This invention, through the aforementioned gradient strain structure design, establishes a stress dispersion mechanism and optimizes bending loss. This allows the stress on the inner layer of fiber 201 to be gradually absorbed and dispersed by the intermediate layer during bending, thereby effectively reducing the impact of fiber 201 bending on optical transmission while maintaining overall flexibility. Theoretical calculations show that this design can reduce the bending loss of fiber 201 by more than 50% at a bending radius of 5mm, while maintaining the flexibility of fiber 201; a bending radius of up to 3mm can be achieved without permanent deformation. Furthermore, by optimizing the material composition and thickness distribution of the intermediate layer, this invention can further improve the fatigue resistance of fiber 201, reduce astigmatism, and improve imaging quality.

[0068] This invention also proposes a method for manufacturing an imaging probe 20, used to manufacture the aforementioned imaging probe 20. Please refer to... Figure 1 and Figure 14 The manufacturing method includes the following steps:

[0069] S10. Perform silanization treatment on the end face of optical fiber 201;

[0070] S20. A conical reflective lens 202 with a total internal reflection surface is 3D printed on the end face of the optical fiber 201.

[0071] S30. Develop the reflective lens 202 with developer for the target time;

[0072] S40. Rinse the reflective lens 202 and then perform a curing process to obtain the imaging probe.

[0073] In this embodiment, the optical fiber 201 is a single-mode optical fiber 201, and the 3D printing material can be a polymer. During manufacturing, the processing flow for the conical reflective lens 202 involves first silanizing the end face of the optical fiber 201 to enhance polymer adhesion; then, using a 3D printing device, a conical reflective lens 202 with a total internal reflection (TIR) ​​surface is directly printed onto the end face of the optical fiber 201 using photoresist; after 3D printing, it can be developed with a developer for 15 minutes; finally, it is rinsed with isopropanol for 3 minutes and cured with a deep ultraviolet lamp for 5 minutes to ensure structural uniformity.

[0074] Furthermore, it is worth mentioning that, in order to reduce the impact of astigmatism from the light source passing through the cylindrical outer tube on imaging, the reflective lens 202 can be designed as a cylindrical reflector based on the inner and outer diameters of the cylindrical outer tube and the refractive index of the inner tube material.

[0075] This invention also proposes an OCT imaging catheter, referring to... Figure 8 and Figure 9The OCT imaging catheter includes an imaging probe 20. The specific structure of the imaging probe 20 is as described in the above embodiments. Since the OCT imaging catheter proposed in this invention includes all the solutions of all the embodiments of the above imaging probe 20, it has at least the same technical effects as the above imaging probe 20, which will not be described in detail here.

[0076] Reference Figure 8 and Figure 9 In one embodiment of the present invention, the OCT imaging catheter further includes a catheter body 10 and a filling fluid; the catheter body 10 forms an inner cavity, and the distal end of the catheter body 10 is provided with an imaging window and a filling space 10a located within the imaging window; the imaging probe 20 is movably inserted into the inner cavity and extends into the filling space 10a at the imaging window; the filling fluid fills the filling space 10a, and the filling fluid is used to change the refraction direction of the light emitted from the lens of the imaging probe 20, so as to reduce astigmatism and attenuation during scanning imaging.

[0077] In this embodiment, the filling fluid is a viscous liquid such as medical silicone oil. This solution not only changes the refraction direction of the light emitted from the lens of the imaging probe 20, but also has a certain degree of smoothness, which helps to improve the smoothness of the imaging probe 20's pull-back and rotational movements within the cavity. In addition, the solution also protects the imaging components as the lens moves within the filling fluid to perform vascular segment imaging.

[0078] It is understood that the present invention improves the distal structure of the OCT imaging catheter. By setting a filling liquid in the filling space 10a within the distal imaging window of the catheter body 10, the lens of the imaging probe 20 performs pull-back and rotation movements in the solution, changing the refraction direction of the light emitted from the lens of the imaging probe 20. This can reduce astigmatism and attenuation during scanning imaging, eliminate the extra light halo outside the imaging probe during catheter scanning imaging due to the absence of contrast agent in the OCT imaging catheter, and reduce the resistance between the high-speed rotating core of the catheter and the inner wall of the distal outer tube 112, thereby improving image quality, effectively ensuring the smoothness of lens rotation and pull-back, and improving imaging quality.

[0079] To further improve the convenience of rotating and pulling back the imaging probe 20, refer to Figures 8 to 13 In one embodiment, the catheter body 10 may include an outer sheath 101, a guidewire tip 102, and a spring tube 103. The guidewire tip 102 is located at the distal end of the outer sheath 101, and the spring tube 103 is sleeved on the outer periphery of the imaging probe 20 and is used to drive the imaging probe 20 to perform a rotational pull-back movement under the drive of an external force. The filling space 10a is formed by the outer sheath 101, the guidewire tip 102, and the spring tube 103.

[0080] It should be noted that the imaging window is transparent, circumferentially positioned, and its length is the same as the pull-back length of the imaging probe 20, allowing light to pass through. The imaging window can be a section of the distal end of the outer sleeve 101, surrounding the outer periphery of the lens, or embedded in a light-transmitting sheet on the distal end of the outer sleeve 101; of course, the imaging window can also be a light-transmitting tube connected to the distal end of the outer sleeve 101, which is not limited here.

[0081] Furthermore, mainly referring to Figure 13 The spring tube 103 may include an inner tube, an outer tube, and a developing ring 104. The outer tube is located around the inner tube and has a peeling portion. The developing ring 104 is located within the peeling portion. Thus, by employing a double-layer spring tube 103 design with a developing ring 104, after peeling off the outer spring tube 103 and welding the developing ring 104 at the peeling location, the spring tube 103 has a developing mark on X-rays. Furthermore, the outer diameter of the spring tube 103 at the weld point is smaller than the outer diameter of the rest of the spring tube 103, which facilitates a smaller outer diameter for the product application section.

[0082] In this embodiment, the developing ring 104 can be made of platinum-iridium material, but there is no limitation here.

[0083] Reference Figure 8 and Figure 11 In one embodiment, the outer sleeve 101 may include a proximal outer sleeve 111 and a distal outer sleeve 112 connected to the proximal outer sleeve 111. The proximal outer sleeve 111 includes an inner layer 1111, a middle layer 1112, and an outer layer 1113 stacked sequentially from the inside out. The inner layer 1111 may be made of PTFE or the like, the middle layer 1112 may be made of 304 stainless steel or the like, and the outer layer 1113 may be made of PI. The distal outer sleeve 112 has a single-layer structure and may be made of Pebax or the like.

[0084] In other words, the proximal outer tube 111 in this embodiment adopts a three-layer structure design: the inner layer 1111 is made of PTFE material, the middle layer is made of stainless steel braided wire, and the outer layer 1113 is made of PI material. This design can enhance the support strength of the proximal end of the catheter, which helps to further improve the overall pushing performance of the catheter. The inner lumen is also more lubricated, which can reduce the resistance between the catheter and the outer tube when the catheter rotates at high speed.

[0085] In this embodiment, refer to Figures 8 to 13The OCT imaging catheter also includes a protective cap 30, a connector 40, a stress buffer tube 50, a pull-back marker 71, a lens marker 72, a connector sleeve 60, and an axis marking strip 73. The protective cap 30 protects the proximal end of the OCT imaging catheter when it is not connected to the main unit. The connector 40 is similar to a handle for easy hand operation. The stress buffer tube 50 provides cushioning during catheter entry into the blood vessel and during advancement. The proximal outer tube 111 is the portion that enters the proximal part of the body. The distal outer tube 112 is the portion that enters the distal part of the body. The guidewire tip 102 guides the catheter body 10 to the target position within the blood vessel. The pull-back marker 71 and the lens marker 72 are used to observe the catheter position. The spring tube 103 is used to rotate and pull back the imaging probe 20. The lens is used for laser imaging and can be constructed from an optical fiber 201 or a lens mounted on the optical fiber 201. The connector sleeve 60 protects the connector 40. The axis marking strip 73 marks the proximal position of the catheter.

[0086] Furthermore, the effective length of the catheter can be set to 1850±50 mm, which is the length that can enter the body. The length of the hydrophilic coating is 1500±50 mm, which is the length of entry into the blood vessel, and is the distance between the axis marker 73 and the most distal end of the OCT imaging catheter. The length of the imaging window is the probe pull-back distance, which can be set to 100±5 mm, and the outer diameter of the imaging window (the outer diameter of the outer sheath 101 where the imaging window is located) can be set to 0.46±0.03 mm. The maximum outer diameter of the catheter insertion portion can be set to 0.46±0.03 mm. The distance between the pull-back mark 71 and the lens mark 72 can be 40±3 mm or 60±3 mm. The length from the lens to the most distal end of the catheter can be set to 20+0 or -3 mm, and the length of the guidewire tip 102 can be set to 15±3 mm.

[0087] It should be noted that blood is composed of plasma and blood cells, with plasma accounting for approximately 55% and water accounting for 90%. To reduce friction during the procedure, in this embodiment, a hydrophilic coating is applied to the outer periphery of the outer cannula 101 of the OCT imaging catheter. The hydrophilic coating can be applied by dipping in a hyaluronic acid (HA)-based solution followed by heat curing. When physiological saline is continuously applied to the hydrophilic coating during insertion into the blood vessel, the friction between the catheter and the blood is significantly reduced, greatly enhancing catheter patency.

[0088] Main reference Figure 12 In one embodiment, the proximal outer tube 111 has a recessed section 1131 on its outer surface at the connection between it and the distal outer tube 112, and the distal outer tube 112 has a mating section 1132 adapted to the recessed section 1131 on its inner surface at the connection between it and the proximal outer tube 111. The mating section 1132 is arranged around the recessed section 1131 and fixed by welding or bonding.

[0089] In this embodiment, the proximal outer tube 111 and the distal outer tube 112 employ a unique welding process. This ensures the strength of the connection between the two outer tubes while also guaranteeing that the outer diameter of the weld does not exceed the outer diameters of the proximal outer tube 111 and the distal outer tube 112. Specifically, the connection between the proximal outer tube 111 and the distal outer tube 112 is achieved through mechanical stripping. Approximately 6-7 mm of the outer surface of the proximal outer tube 111 is uniformly stripped of about half the wall thickness, forming an outer step shape, i.e., the aforementioned countersunk section 1131. Similarly, approximately 6-7 mm of the inner surface of the distal outer tube 112 is uniformly stripped of about half the wall thickness, forming an inner step shape, i.e., the aforementioned mating section 1132. After peeling off the outer layer 1113 of the proximal outer cannula 111 and the inner layer 1111 of the distal outer cannula 112, they are joined by heat fusion or adhesive bonding. The difference between the peeling thickness of the inner layer 1111 of the distal outer cannula 112 and the peeling thickness of the outer layer 1113 of the proximal outer cannula 111 is equal to the adhesive bonding thickness. This ensures the smoothness of the catheter after the proximal and distal outer cannulas 112 are bonded together, while also preventing the connection size from increasing. This design allows for a smaller outer diameter of the catheter's application segment, resulting in better passage in clinical applications.

[0090] In summary, in this invention, the reflecting lens 202 of the imaging probe 20 adopts a conical design, which can form a fine light spot during scanning and imaging, reducing astigmatism. In this invention, the reflecting lens 202 is printed using 3D printing technology, enabling high-resolution, large depth-of-field imaging. In this invention, filling the lens pull-back section within the cavity with a solution can alter the refraction of the guide tube lens, improving image quality. In this invention, placing a coreless optical fiber 204 between the single-mode optical fiber 201 and the reflecting lens 202 to guide the light beam can reduce light loss and scattering during transmission, improving imaging resolution.

[0091] The above description is merely an optional embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural transformations made using the contents of the present invention's specification and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. An imaging probe, characterized in that, include: Optical fiber, wherein the optical fiber is a single-mode optical fiber; and A reflecting lens is disposed at the distal end of the optical fiber, and the reflecting lens has a reflecting surface and a light-emitting surface; In the radial direction of the imaging probe, the projection of the reflective surface is arc-shaped, and the tangent of the reflective surface intersects the centerline of the optical fiber to form an angle with the opening facing the far end of the optical fiber and not the light-emitting surface. The angle is acute. The outer periphery of the optical fiber and the reflective lens connected to its end is covered with a gradient strain layer and a protective layer from the inside out. The gradient strain layer is used to reduce stress concentration, and the protective layer is used to enhance flexibility and protect the optical fiber and the reflective lens. The gradient strain layer is made of an elastic polymer material, and the protective layer is made of a polymer material.

2. The imaging probe as described in claim 1, characterized in that, In the radial direction of the imaging probe, the projection of the light-emitting surface and the projection of the optical fiber are on the same straight line.

3. The imaging probe as described in claim 1, characterized in that, In the radial direction of the imaging probe, the projection of the light-emitting surface is an arc, and the cross-section of the light-emitting surface is parallel to the centerline of the optical fiber.

4. The imaging probe as described in claim 1, characterized in that, The imaging probe also includes a focusing lens, which is disposed between the distal end of the optical fiber and the reflecting lens, and is used to focus light onto the reflecting surface of the reflecting lens.

5. The imaging probe as described in claim 4, characterized in that, In the radial direction of the imaging probe, the light-emitting surface and the reflecting surface are symmetrically arranged about the center line of the optical fiber.

6. The imaging probe as described in claim 1, characterized in that, The imaging probe also includes a coreless optical fiber located between the optical fiber and the reflecting lens, the coreless optical fiber being used to expand the beam of light emitted from the optical fiber.

7. The imaging probe as described in claim 4, characterized in that, The imaging probe also includes a coreless optical fiber located between the optical fiber and the focusing lens, the coreless optical fiber being used to expand the beam of light emitted from the optical fiber.

8. An OCT imaging catheter, characterized in that, include: The catheter body has an inner lumen, and an imaging window is provided at the distal end of the catheter body; as well as The imaging probe as described in any one of claims 1 to 7, wherein the imaging probe is movably inserted into the cavity and extends to the imaging window.

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