OCT (Optical Coherence Tomography) imaging catheter, imaging probe and manufacturing method thereof

Abstract

The invention discloses an OCT (optical coherence tomography) imaging catheter, an imaging probe and a manufacturing method of the imaging probe, and relates to the technical field of medical instruments. The imaging probe comprises an optical fiber and a reflecting lens, the reflecting lens is arranged at the far end of the optical fiber, and the reflecting lens is provided with 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 plane of the reflecting surface intersects with the center line of the optical fiber and forms an included angle with an opening facing the far end of the optical fiber and the non-light-emitting surface side, and the included angle is an acute angle. According to the OCT imaging catheter, the imaging probe structure of the OCT imaging catheter is improved, the curved conical lens is adopted, efficient focusing of light beams is achieved, fine light spots can be formed, astigmatism is reduced, and the imaging quality is improved. The structure is convenient to miniaturize and flexible to bend, and the spatial resolution of the probe is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an OCT imaging catheter, an imaging probe and a manufacturing method thereof. Background Art

[0002] Since the images acquired by the OCT (Optical Coherence Tomography) imaging technology are relatively clear and can completely and clearly observe the situation of the target part, it has now become a relatively mainstream blood vessel imaging method. Currently, OCT imaging catheters have been widely used in fields such as coronary blood vessels and intracranial blood vessels.

[0003] However, due to the thinness and complexity of intracranial blood vessels, when performing intracranial blood vessel imaging, during the process of the OCT imaging catheter shuttling through intracranial blood vessels with multiple bends, thinness and high complexity, the optical fiber is prone to cause attenuation such as loss and scattering of light during transmission due to bending, resulting in poor imaging quality. Summary of the Invention

[0004] The main purpose of the present invention is to provide an OCT imaging catheter, an imaging probe and a manufacturing method thereof, aiming to improve the imaging quality.

[0005] To achieve the above object, the present invention provides an imaging probe, including: an optical fiber; and a reflection lens provided at the distal end of the optical fiber, the reflection lens having a reflection surface and an outgoing light surface; in the radial direction of the imaging probe, the projection of the reflection surface is arc-shaped, and the section plane of the reflection surface intersects with the central axis of the optical fiber and forms an acute angle with an opening facing the distal end of the optical fiber and on the non-outgoing light surface side.

[0006] Optionally, in the radial direction of the imaging probe, the projection of the outgoing light surface and the projection of the optical fiber are on the same straight line.

[0007] Optionally, in the radial direction of the imaging probe, the projection of the outgoing light surface is an arc, and the section plane of the outgoing light surface is parallel to the central axis of the optical fiber.

[0008] Optionally, the imaging probe further includes a focusing lens provided between the distal end of the optical fiber and the reflection lens, and the focusing lens is used to focus light onto the reflection surface of the reflection lens.

[0009] Optionally, in the radial direction of the imaging probe, the outgoing light surface and the reflection surface are symmetrically arranged with respect to the central axis of the optical fiber.

[0010] Optionally, the outer periphery of the optical fiber and the reflection lens connected to its end are sequentially covered with a gradient strain layer and a protective layer from the inside to the outside. 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 reflection lens.

[0011] Optionally, the imaging probe further includes a coreless optical fiber located between the optical fiber and the reflection lens, and the coreless optical fiber is used for beam expansion processing of the light emitted by the optical fiber.

[0012] Optionally, the imaging probe further includes a coreless optical fiber located between the optical fiber and the focusing lens, and the coreless optical fiber is used for beam expansion processing of the light emitted by the optical fiber.

[0013] To achieve the above object, the present invention proposes a manufacturing method of an imaging probe for manufacturing the above imaging probe. The manufacturing method includes the following steps: Perform silanization treatment on the end face of the optical fiber; 3D print a conical reflection lens with a total internal reflection surface on the end face of the optical fiber; Develop the reflection lens with a developer for a target time; Rinse the reflection lens and then perform a curing treatment to obtain the imaging probe.

[0014] To achieve the above object, the present invention also proposes an OCT imaging catheter, including: A catheter body having a lumen formed therein, and an imaging window is provided at the distal end of the catheter body; and An imaging probe, the imaging probe is movably inserted into the lumen and extends to the imaging window; the imaging probe includes: An optical fiber; and A reflection lens provided at the distal end of the optical fiber, the reflection lens having a reflection surface and a light output surface; in the radial direction of the imaging probe, the projection of the reflection surface is arc-shaped, and the section plane of the reflection surface intersects the central axis of the optical fiber and forms an acute angle with an opening facing the distal end of the optical fiber and on the side other than the light output surface.

[0015] In the technical solution of the present invention, the imaging probe includes an optical fiber and a reflecting lens. The reflecting lens is provided 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 section plane of the reflecting surface intersects with the central axis of the optical fiber and forms an angle with an opening facing the distal end of the optical fiber and on the side other than the light-emitting surface. The angle is an acute angle. It can be understood that the present invention improves the imaging probe structure of the OCT imaging catheter. By using a curved conical lens, efficient focusing of the light beam is achieved, a fine light spot can be formed, astigmatism is reduced, and the imaging quality is improved. Moreover, this structure facilitates miniaturization, flexible bending, and improves the spatial resolution of the probe. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on the structures shown in these drawings.

[0017] Figure 1 Schematic diagram of the structure of an embodiment of the imaging probe of the present invention; Figure 2 For Figure 1 Schematic diagram of the angle formed by the section plane of the reflecting lens and the central axis of the optical fiber in Figure 3 Schematic diagram of the structure of another embodiment of the imaging probe of the present invention; Figure 4 Schematic diagram of the structure of yet another embodiment of the imaging probe of the present invention; Figure 5 Schematic diagram of the structure of still another embodiment of the imaging probe of the present invention; Figure 6 Schematic diagram of the structure of still another embodiment of the imaging probe of the present invention; Figure 7 Schematic diagram of the structure of one embodiment of the imaging probe of the present invention; Figure 8 Schematic diagram of the structure of an embodiment of the OCT imaging catheter of the present invention; Figure 9 For Figure 8 Enlarged view of the local area A in Figure 10 For Figure 8 Enlarged view of the local area B in Figure 11 Schematic diagram of the structure of the proximal outer tube in an embodiment of the OCT imaging catheter of the present invention; Figure 12Schematic diagram of the connection between the proximal outer tube and the distal outer tube in an embodiment of the OCT imaging catheter of the present invention; Figure 13 Schematic diagram of the structure of the spring tube and the cross-sectional view of the spring tube at the visible ring thereon in an embodiment of the OCT imaging catheter of the present invention; Figure 14 Schematic flow chart of an embodiment of the manufacturing method of the imaging probe of the present invention.

[0018] Explanation of the reference numerals in the drawings: 10. Catheter body; 20. Imaging probe; 10a. Filling space; 101. Outer sleeve; 102. Guide wire head; 103. Spring tube; 104. Visible ring; 201. Optical fiber; 202. Reflective 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. Counterbore section; 1132. Matching section; 30. Protective cover; 40. Connecting seat; 50. Stress buffer tube; 60. Connecting seat sheath; 71. Pull-back mark; 72. Lens mark; 73. Axial marking tape; 221. Reflective surface; 222. Light-emitting surface; 2031. Gradient strain layer; 2032. Protective layer.

[0019] The realization, functional features and advantages of the object of the present invention will be further described in conjunction with the embodiments with reference to the accompanying drawings. Detailed implementation manners

[0020] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0021] It should be noted that all directional indications (such as up, down, left, right, front, back...) in the embodiments of the present invention are only used to explain the relative position relationship and movement conditions between components in a specific posture (as shown in the drawings). If the specific posture changes, the directional indications will also change accordingly.

[0022] In the description of the present invention, it should also be noted that unless otherwise clearly defined and limited, the terms "installation", "connection" and "connection" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication between two components inside. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0023] In addition, the descriptions involving "first", "second", etc. in the present invention are for descriptive purposes only, and should not be construed as indicating or implying their relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. The meaning of "and / or" appearing throughout the text is that it includes three parallel solutions. Taking "A and / or B" as an example, it includes solution A, or solution B, or the solution where both A and B are satisfied simultaneously. The technical solutions between various embodiments can be combined with each other, but it must be based on what can be achieved by those of ordinary skill in the art. When the combination of technical solutions is contradictory or cannot be achieved, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0024] The present invention provides an imaging probe, which can be applicable to fields such as coronary blood vessels and intracranial blood vessels, and is not limited herein.

[0025] Refer to 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. The reflecting lens 202 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 section plane of the reflecting surface 221 intersects with the central axis of the optical fiber 201 to form an angle α with an opening facing the distal end of the optical fiber 201 and on the side other than the light-emitting surface 222, and the angle α is an acute angle.

[0026] In this embodiment, the optical fiber 201 can be a single-mode optical fiber 201 (SMF), etc. The size of the angle α is preferably 45°, and is not limited herein.

[0027] The reflecting mirror can be manufactured with high precision by using 3D printing technology, and can also be subjected to free-form surface design, material optimization, miniaturization and integration, as well as customized design, which is beneficial to achieving high-resolution and large-depth-of-field imaging.

[0028] It can be understood that the present invention improves the structure of the imaging probe 20 of the OCT imaging catheter. By adopting the curved surface conical reflecting lens 202, efficient focusing of the light beam is achieved, a fine light spot can be formed, astigmatism is reduced, and the imaging quality is improved. Moreover, this structure is convenient for miniaturization, flexible bending, and improves the spatial resolution of the probe.

[0029] Mainly refer to Figure 1 and Figure 2 In one embodiment, in the radial direction of the imaging probe 20, the projection of the light-emitting surface 222 is flush with the projection of the optical fiber 201, that is, the projection lines of the two are on the same straight line. In this way, it is convenient for processing and manufacturing, and cost can be saved.

[0030] Main reference Figure 3 Figure 3 , in another embodiment, in the radial direction of the imaging probe 20, the projection of the light-emitting surface 222 can also be an arc, and the section plane of the light-emitting surface 222 is parallel to the central axis of the optical fiber 201. Such a setting can further focus the light beam and further improve the imaging quality of the imaging probe 20.

[0031] Main reference Figure 4 Figure 4 , in one embodiment, the imaging probe 20 may further include a focusing lens 203. The focusing lens 203 is disposed between the distal end of the optical fiber 201 and the reflecting lens 202. The focusing lens 203 is used to focus the 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 with respect to the central axis of the optical fiber 201. The focusing lens 203 has a focusing surface. In the radial direction of the imaging probe 20, the projection of the focusing surface is an arc with the center of the circle located on one side of the reflecting lens 202.

[0032] In this embodiment, in order to reduce the diameter of the optical fiber 201 and avoid the breakage of the imaging probe 20, on the basis of the aforementioned reflecting lens 202 with double arc surfaces, a focusing lens 203 is provided to focus the light beam onto the reflecting surface 221 of the reflecting lens 202, ensuring that the diameters of the lens and the optical fiber 201 remain unchanged, and the conical reflecting lens 202 has two symmetric arc surfaces.

[0033] In addition, a multi-layer structure can be provided on the reflecting lens 202 for protection, such as covering a crystal head or the like.

[0034] Main reference Figure 5 and Figure 6 Figure 6 , in some other embodiments, the imaging probe 20 may further include a coreless optical fiber 204 located between the single-mode optical fiber 201 and the reflecting lens 202. The coreless optical fiber 204 is used to perform beam expansion on the light emitted by the single-mode optical fiber 201.

[0035] This embodiment includes at least the following three technical solutions: Solution 1, as Figure 5 shown, the projection of the light-emitting surface 222 can be on the same straight line as the single-mode optical fiber 201 and the coreless optical fiber 204, that is, flush.

[0036] Solution 2, as Figure 6 shown, the projection of the light-emitting surface 222 can be an arc, and the section plane of the light-emitting surface 222 is parallel to the central axis of the optical fiber 201.

[0037] Solution 3, based on the aforementioned solution with the focusing lens 203, referring to Figure 4 , further, a coreless optical fiber 204 can be provided between the single-mode optical fiber 201 and the focusing lens 203 of the imaging probe 20 ( Figure 4(not shown), which can further improve the imaging quality.

[0038] In this embodiment, by adding a coreless optical fiber 204, the beam of the single-mode optical fiber 201 is expanded, and the light emitted from the core of the single-mode optical fiber 201 is expanded to a certain extent to guide the beam, which can reduce the loss and scattering of light during transmission, thereby improving the imaging resolution.

[0039] To reduce the stress concentration of the optical fiber 201 and, while ensuring the flexibility of the overall imaging probe 20, reduce the influence of the bending of the optical fiber 201 on light transmission, mainly referring to Figure 7 , in one embodiment, the optical fiber 201 is a single-mode optical fiber 201, and the outer periphery of the single-mode optical fiber 201 and the reflecting lens 202 connected to its end are sequentially 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 reflecting lens 202 and protect the single-mode optical fiber 201 and the reflecting lens 202.

[0040] In this embodiment, the optical fiber 201 of the imaging probe 20 adopts a new gradient strain structure, and the optical fiber 201 is divided into three layers from the inside to the outside: 1) The inner layer is the structure of a traditional single-mode optical fiber 201 with a diameter of about 9 μm; 2) The middle layer is the gradient strain layer 2031 with a thickness of about 20 - 30 μm, and a special elastic polymer material can be used, and its Young's modulus gradually decreases from the inside to the outside to form a stress gradient; 3) The outer layer is the protective layer 2032, and a soft polymer material can be used.

[0041] That is to say, on the basis of the conventional single-mode optical fiber 201 in this embodiment, two structural layers are further covered on the outer periphery of the single-mode optical fiber 201 and its distal reflecting lens 202. One is the gradient strain layer 2031 in the middle, and the other is the protective layer 2032 on the outermost side. In the present invention, the two structural layers are not limited to covering the imaging probe such as the single-mode optical fiber 201, the reflecting lens 202, the focusing lens 203, and the coreless optical fiber 204.

[0042] By adopting the above-mentioned gradient strain structure design, the present invention forms a stress dispersion mechanism and optimizes the bending loss, so that when the optical fiber 201 is bent, the stress received by the inner layer can be gradually absorbed and dispersed by the middle layer, thereby effectively reducing the influence of the bending of the optical fiber 201 on light transmission while maintaining the overall flexibility. Theoretical calculations show that this design can reduce the bending loss of the optical fiber 201 by more than 50% at a bending radius of 5 mm, and at the same time maintain the flexibility of the optical fiber 201, and the bending radius can reach 3 mm without causing permanent deformation. In addition, by optimizing the material composition and thickness distribution of the middle layer, the present invention can further improve the anti-fatigue performance of the optical fiber 201, reduce astigmatism, and improve the imaging quality.

[0043] The present invention also provides a manufacturing method for the imaging probe 20, which is used to manufacture the above-mentioned imaging probe 20. Please refer to Figure 1 and Figure 14 . The manufacturing method includes the following steps: S10. Perform silanization treatment on the end face of the optical fiber 201; S20. 3D print a conical reflecting lens 202 with a total internal reflection surface on the end face of the optical fiber 201; S30. Develop the reflecting lens 202 with a developer for a target time; S40. Rinse the reflecting lens 202 and then perform a curing treatment to obtain the imaging probe.

[0044] In this embodiment, the optical fiber 201 uses a single-mode optical fiber 201, and the material for 3D printing can be selected as a polymer. During manufacturing, the processing flow of the conical reflecting lens 202 is as follows: First, perform silanization treatment on the end face of the optical fiber 201 to enhance the adhesion of the polymer; then use a 3D printing device to directly print a conical reflecting lens 202 with a total internal reflection (TIR) surface on the end face of the optical fiber 201 using a photoresist; after 3D printing, the developer can be used to develop for 15 minutes; finally, rinse with isopropanol for 3 minutes and cure with a deep ultraviolet lamp for 5 minutes to ensure a uniform structure.

[0045] In addition, it is worth mentioning that in order to reduce the influence of the light source's astigmatism passing through the cylindrical outer tube on imaging, the reflecting lens 202 can design a cylindrical mirror according to the inner diameter and outer diameter of the cylindrical outer tube and the refractive index of the inner tube material.

[0046] The present invention also provides an OCT imaging catheter. Referring to Figure 8 and Figure 9 , the OCT imaging catheter includes an imaging probe 20, and the specific structure of the imaging probe 20 refers to the above embodiment. Since the OCT imaging catheter proposed by the present invention includes all the solutions of all the above embodiments of the imaging probe 20, therefore, it has at least the same technical effects as the above imaging probe 20, and will not be elaborated one by one here.

[0047] Referring to Figure 8 and Figure 9 , in an embodiment of the present invention, the OCT imaging catheter further includes a catheter body 10 and a filling liquid; 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 in 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 liquid is filled in the filling space 10a, and the filling liquid is used to change the refraction direction of the light emitted from the lens of the imaging probe 20 to reduce astigmatism and attenuation during scanning imaging.

[0048] In this embodiment, the filling liquid is a viscous liquid such as medical silicone oil. This solution can not only change the refraction direction of the light emitted by the lens of the imaging probe 20, but also has a certain smoothness, which helps to improve the smoothness of the back-and-forth pulling and rotational movements of the imaging probe 20 in the inner cavity. In addition, when the lens moves in the filling liquid for vascular segment imaging, the solution can also protect the imaging components.

[0049] It can be understood that the present invention improves the distal structure of the OCT imaging catheter. By arranging 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 makes back-and-forth pulling and rotational movements in the solution, changing the refraction direction of the light emitted by the lens of the imaging probe 20. It can reduce astigmatism and attenuation during scanning imaging, eliminate the extra halos 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 rotation of the catheter core and the inner wall of the distal outer tube 112, thereby improving the image quality, effectively ensuring the smoothness of the lens rotation and back-and-forth pulling, and improving the imaging quality.

[0050] To further improve the convenience of the rotational back-and-forth movement of the imaging probe 20, referring to Figures 8 to 13 , in one embodiment, the catheter body 10 may include an outer sleeve 101, a guide wire head 102, and a spring tube 103. The guide wire head 102 is provided at the distal end of the outer sleeve 101. 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 rotational back-and-forth movement under the drive of an external force. The filling space 10a is formed by enclosing the outer sleeve 101, the guide wire head 102, and the spring tube 103.

[0051] It should be noted that the imaging window has light transmissivity and is circumferentially arranged, and its length is the same as the back-and-forth pulling length of the imaging probe 20, and it can allow light to pass through. The imaging window can be a part of the tube segment at the distal end of the outer sleeve 101, arranged around the outer periphery of the lens, or a light-transmitting sheet embedded in 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, and this is not limited here.

[0052] Furthermore, mainly referring to Figure 13 , the spring tube 103 may include an inner layer tube, an outer layer tube, and a developing ring 104. The outer layer tube is arranged on the outer periphery of the inner layer tube, and a peeling part is provided on the outer layer tube. The developing ring 104 is arranged within the peeling part. In this way, by adopting the design of a double-layer spring tube 103 plus a developing ring 104, after peeling the outer layer spring tube 103 and welding the developing ring 104 at the peeling position, the spring tube 103 has a developing mark in X-rays, and the outer diameter of the spring tube 103 at the welding position is smaller than the outer diameter of the rest of the spring tube 103, which is beneficial to making the outer diameter of the product application section smaller.

[0053] In this embodiment, the developing ring 104 can be made of platinum-iridium material, and this is not limited here.

[0054] Referring to Figure 8 and Figure 11 In one embodiment, the outer catheter 101 may include a proximal outer tube 111 and a distal outer tube 112 connected to the proximal outer tube 111. The proximal outer tube 111 includes an inner layer 1111, a middle layer 1112, and an outer layer 1113 that are stacked in sequence from the inside out. The material of the inner layer 1111 may be PTFE or the like, the material of the middle layer 1112 may be 304 stainless steel or the like, and the material of the outer layer 1113 may be PI. The distal outer tube 112 is a single-layer structure, and the material may be Pebax or the like.

[0055] That is to say, the proximal outer tube 111 of this embodiment adopts a three-layer structure design, with the inner layer 1111 being made of PTFE material, the middle layer being made of stainless steel braided wire, and the outer layer 1113 being a three-layer outer tube made of PI material. Such a setting can enhance the support strength of the proximal end of the catheter, help to further improve the overall pushing performance of the catheter, make the inner cavity more lubricated, and reduce the resistance between the catheter and the outer tube when the catheter rotates at high speed.

[0056] In this embodiment, referring to Figures 8 to 13 , the OCT imaging catheter further includes a protective cap 30, a connection seat 40, a stress buffer tube 50, a pull-back mark 71, a lens mark 72, a connection seat sheath 60, an axis mark band 73, etc. Among them, the protective cap 30 is used to protect the proximal end of the OCT imaging catheter when the catheter is not plugged into the host. The connection seat 40 is similar to a handle and facilitates hand operation. The stress buffer tube 50 is used for buffering when the catheter enters the blood vessel and is pushed. The proximal outer tube 111 is the proximal part entering the human body. The distal outer tube 112 is the distal part entering the human body. The guide wire head 102 is used to guide the catheter body 10 to the target position in the blood vessel. The pull-back mark 71 and the lens mark 72 are used to observe the position of the catheter. The spring tube 103 is used to drive the imaging probe 20 to rotate and pull back. The lens is used to emit laser for imaging and may be composed of an optical fiber 201 or a lens provided on the optical fiber 201. The connection seat sheath 60 is used to protect the connection seat 40. The axis mark band 73 is used to mark the proximal position of the catheter.

[0057] Furthermore, the effective length of the catheter can be set to 1850 ± 50 mm, and the effective length is the length that can enter the body. The length of the hydrophilic coating is the length entering the blood vessel, which can be set to 1500 ± 50 mm, and the length of the hydrophilic coating is the distance between the shaft marking band 73 and the most distal end of the OCT imaging catheter. The length of the imaging window is the distance of the probe retraction, which can be set to 100 ± 5 mm, and the outer diameter of the imaging window (the outer diameter of the outer sleeve 101 where the imaging window is located) can be set to 0.46 ± 0.03 mm. The maximum outer diameter of the catheter insertion part can be set to 0.46 ± 0.03 mm. The distance between the retraction 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 guide wire tip 102 can be set to 15 ± 3 mm.

[0058] It should be noted that blood is composed of plasma and blood cells, and plasma accounts for about 55%, and water accounts for 90% of plasma. In order to reduce friction during the operation, in this embodiment, a hydrophilic coating is applied to the outer periphery of the outer sleeve 101 of the OCT imaging catheter; the hydrophilic coating can be applied by dip coating with a hyaluronic acid (HA)-based solution and then thermally cured. When normal saline is continuously applied to the hydrophilic coating during the insertion into the blood vessel, the frictional force between the catheter and the blood is significantly reduced, greatly enhancing the smoothness of the catheter.

[0059] Mainly referring to Figure 12 , in one embodiment, the proximal outer tube 111 is provided with a counterbore section 1131 on the outer surface at its connection with the distal outer tube 112, and the distal outer tube 112 is provided with a mating section 1132 on the inner surface at its connection with the proximal outer tube 111, which is adapted to the counterbore section 1131. The mating section 1132 is arranged around the counterbore section 1131 and fixed by welding or bonding.

[0060] In this embodiment, a unique welding process is adopted for the proximal outer tube 111 and the distal outer tube 112. While ensuring the strength of the connection between the two outer tubes, it also ensures that the outer diameter of the welded part does not exceed the outer diameters of the proximal outer tube 111 and the distal outer tube 112. Specifically, mechanical stripping is used at the connection of the proximal outer tube 111 and the distal outer tube 112. The outer surface of the tube of the proximal outer tube 111 with a length of about 6 - 7 mm at the distal end is evenly stripped by about 1 / 2 of the wall thickness to form an outer stepped shape, that is, the above-mentioned counterbore section 1131; the inner surface of the tube of the distal outer tube 112 with a length of about 6 - 7 mm at the proximal end is evenly stripped by about 1 / 2 of the wall thickness to form an inner stepped shape, that is, the above-mentioned mating section 1132. After stripping the outer layer 1113 of the proximal outer tube 111 and the inner layer 1111 of the distal outer tube 112, a fusion welding method or an adhesive bonding method is used for connection. The difference between the stripping thickness of the inner layer 1111 of the distal outer tube 112 and the stripping thickness of the outer layer 1113 of the proximal outer tube 111 is equal to the adhesive thickness. At this time, the smoothness of the catheter after gluing the proximal and distal outer tubes 112 can be ensured, and at the same time, the size of the connection part does not increase. Such a setting can make the outer diameter of the application section of the catheter smaller and the passability better in clinical applications.

[0061] In summary, in the present invention, the reflection lens 202 of the imaging probe 20 adopts a conical design, which can form a fine light spot during scanning imaging and reduce astigmatism. In the present invention, the reflection lens 202 adopts 3D printing technology, which can achieve high-resolution and large-depth-of-field imaging. In the present invention, a solution is filled in the lens retraction section of the inner cavity, which can change the refraction of the catheter lens and improve the imaging quality. In the present invention, a coreless optical fiber 204 is arranged between the single-mode optical fiber 201 and the reflection lens 202 to guide the light beam, which can reduce the loss and scattering of light during transmission and improve the imaging resolution.

[0062] The above are only optional embodiments of the present invention, and do not limit the patent scope of the present invention accordingly. Any equivalent structural transformation made under the inventive concept of the present invention by using the content of the specification and drawings of the present invention, or any direct / indirect application in other related technical fields, is included in the patent protection scope of the present invention.

Claims

1. An imaging probe, characterized in that, Comprising: Optical fiber; And A reflective lens disposed at the distal end of the optical fiber, the reflective lens having a reflective 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 plane of the reflective surface intersects the central axis of the optical fiber to form an acute angle with the opening facing the distal end of the optical fiber and on the side other than the light-emitting surface.

2. The imaging probe according to claim 1, wherein 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 according to claim 1, wherein In the radial direction of the imaging probe, the projection of the light-emitting surface is an arc, and the tangent plane of the light-emitting surface is parallel to the central axis of the optical fiber.

4. The imaging probe according to claim 1, wherein The imaging probe further includes a focusing lens disposed between the distal end of the optical fiber and the reflective lens, and the focusing lens is used to focus light onto the reflective surface of the reflective lens.

5. The imaging probe according to claim 4, characterized in that, In the radial direction of the imaging probe, the light-emitting surface and the reflective surface are symmetrically arranged with respect to the central axis of the optical fiber.

6. The imaging probe according to claim 1, characterized in that, The outer periphery of the optical fiber and the reflective lens connected to its end is sequentially 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.

7. The imaging probe according to claim 1, wherein The imaging probe further includes a coreless optical fiber located between the optical fiber and the reflective lens, and the coreless optical fiber is used to perform beam expansion processing on the light emitted by the optical fiber.

8. The imaging probe according to claim 4, characterized in that, The imaging probe further includes a coreless optical fiber located between the optical fiber and the focusing lens, and the coreless optical fiber is used to perform beam expansion processing on the light emitted by the optical fiber.

9. A manufacturing method of an imaging probe for manufacturing the imaging probe according to any one of claims 1 to 8, characterized in that, The manufacturing method includes the following steps: Perform silanization treatment on the end face of the optical fiber; 3D print a conical reflective lens with a total internal reflection surface on the end face of the optical fiber; Develop the reflective lens with a developer for a target time; Rinse the reflective lens and then perform a curing treatment to obtain the imaging probe.

10. An OCT imaging catheter, characterized in that, Comprising: A catheter body having a lumen formed therein, and an imaging window is provided at the distal end of the catheter body; And The imaging probe according to any one of claims 1 to 8, and the imaging probe is movably inserted into the lumen and extends to the imaging window.

Images