SS-OCT catheter structure with small bending radius

Abstract

The invention discloses an SS-OCT catheter with a small bending radius. The SS-OCT catheter with the small bending radius is formed by combining a catheter sheath and a catheter core located in the catheter sheath. The catheter core comprises an optical lens assembly located at the far end of the catheter core and used for sending and receiving optical signals; the optical fiber is located at the near end of the optical lens assembly and connected with the optical lens assembly, and optical signal transmission can be conducted between the optical fiber and the optical lens assembly; the optical fiber connector is located at the near end of the catheter core and connected with the optical fiber.

Description

Technical Field

[0001] The present application relates to the technical field of medical imaging SS-OCT catheters, and in particular to a SS-OCT catheter structure with a small bending radius. Background Art

[0002] Coronary artery disease can cause chest pain, myocardial ischemia and sudden cardiac death due to the accumulation, rupture and thrombosis of atherosclerotic plaques. Treatment of plaques includes the introduction of percutaneous coronary intervention (PCI), in which cardiologists use catheters to insert into the coronary arteries, and in the past, coronary angiography was used to evaluate the condition and guide stenting to treat the lesions.

[0003] However, the abuse or overuse of heart stents in recent years has caused a lot of controversy, and doctors are more cautious and picky when considering the use of stents. DSA observation is no longer applicable to biodegradable absorbable stents, and more intuitive intravascular images are needed to accurately judge and diagnose.

[0004] Using OCT, we have seen a modest decrease in stenting in patients with stable coronary artery disease. A large amount of clinical data shows that using only coronary angiography DSA results to formulate revascularization treatment strategies is not accurate enough. Summary of the invention

[0005] SS-OCT imaging technology can be used for imaging diagnosis of coronary artery intervention, accurately guide cardiovascular stent implantation, and evaluate the postoperative stent implantation. The most important component of SS-OCT imaging technology, the OCT catheter, plays a key role in sending and receiving optical signals. Its technical performance determines the accurate diagnosis of SS-OCT images, and its geometric structure determines that it can be used in different parts of human tissue. At present, SS-OCT imaging on the market is mainly used in cardiovascular medicine or ophthalmology. The SS-OCT imaging mentioned here is mainly for cardiovascular and neurovascular applications. The catheters used in the current market are relatively large in structure, and the inner diameter of the blood vessels that can be used and clearly imaged is generally 1.5 to 4 mm. The merchants only guarantee that the inner diameter of the blood vessels used is in the range of 2.0 to 3.5 mm, and it is not yet possible to effectively image and diagnose thinner (less than 1 mm) cardiovascular or neurovascular vessels.

[0006] In order to solve the problems existing in the prior art, the present application provides a SS-OCT catheter structure with a small bending radius.

[0007] The specific technical solutions of this application are as follows:

[0008] A SS-OCT catheter with a small bending radius, wherein the catheter is composed of a catheter sheath and a catheter core located inside the catheter sheath;

[0009] The catheter core comprises:

[0010] An optical lens assembly, located at the distal end of the catheter core, for emitting and receiving optical signals;

[0011] The optical fiber is located at the proximal end of the optical lens assembly and connected to the optical lens assembly, and is capable of transmitting optical signals between the optical lens assembly and the optical lens assembly;

[0012] an optical fiber connector, located at the proximal end of the catheter core and connected to the optical fiber;

[0013] The catheter sheath comprises:

[0014] A window tube is located outside the optical lens assembly, and the optical signal in the optical lens assembly can pass through the window tube;

[0015] Preferably, the outer diameter of the window tube is 0.2-0.8 mm, and the inner diameter is 0.1-0.2 mm;

[0016] Further preferably, the outer diameter of the window tube is 0.3-0.5 mm, and the inner diameter is 0.16-0.25 mm.

[0017] In a specific embodiment, the optical lens assembly comprises:

[0018] A steering reflector, located at the front end of the conduit core, is used to reflect or redirect the optical signal to a desired direction;

[0019] The optical cylindrical lens is located near the beam steering reflector and can effectively focus the optical signal;

[0020] The linear optical lens is located at the proximal end of the optical cylindrical lens and can amplify the optical signal.

[0021] In a specific embodiment, the optical cylindrical lens, the linear optical lens, the optical fiber and the steering reflector are coaxially arranged.

[0022] In a specific embodiment, the angle between the reflecting surface of the steering reflector and the axial direction is 30-50 degrees;

[0023] Preferably, the angle between the reflecting surface of the steering reflector and the axial direction is 35-45 degrees.

[0024] Further preferably, the angle between the reflecting surface of the steering reflector and the axial direction is 37-41 degrees.

[0025] In a specific embodiment, the length of the linear optical lens is 200-800um;

[0026] Preferably, the length of the linear optical lens is 300-500um;

[0027] Further preferably, the length of the linear optical lens is 350-450 um.

[0028] In a specific embodiment, the length of the optical cylindrical lens is 150-600um;

[0029] Preferably, the length of the optical cylindrical lens is 200-450um;

[0030] Further preferably, the length of the optical cylindrical lens is 270-330 um.

[0031] In a specific embodiment, a lens protection tube is provided at the distal end of the catheter core, and the lens protection tube is located at the distal end of the optical lens assembly.

[0032] In a specific embodiment, the optical fiber is a standard single-mode optical fiber for enhanced communication transmission.

[0033] In a specific embodiment, the catheter core further comprises:

[0034] The torque transmission tube is used for transmitting torque so that the optical lens assembly can rotate.

[0035] In a specific embodiment, the conduit core comprises:

[0036] The nickel-titanium conductive tube is arranged at the proximal end of the catheter core, and the nickel-titanium conductive tube is sleeved on the outside of the optical fiber to protect the optical fiber.

[0037] In a specific embodiment, the catheter sheath comprises:

[0038] A guidewire channel is located at the distal end of the catheter sheath, and a guidewire for guiding can be placed inside the guidewire channel;

[0039] The guide wire channel is located at the distal end of the window tube.

[0040] In a specific embodiment, the window tube is bonded to the guide wire channel using glue;

[0041] Preferably, the connection between the window tube and the guide wire channel is bonded with ultraviolet glue;

[0042] Further preferably, the bonding length of the UV glue at the connection between the window tube and the guide wire channel is greater than 0.3 mm;

[0043] Further preferably, the bonding length of the UV glue at the connection between the window tube and the guide wire channel in the axial direction is greater than 0.5 mm.

[0044] In a specific embodiment, the catheter sheath comprises:

[0045] The catheter shaft is located at the proximal end of the window tube and connected to the window tube; the optical fiber is located inside the catheter shaft.

[0046] In a specific embodiment, the catheter sheath comprises:

[0047] The transition sheath is located between the window tube and the catheter shaft, and two ends of the transition sheath are respectively connected to the window tube and the catheter shaft.

[0048] In a specific embodiment, the catheter sheath comprises:

[0049] A catheter head is located at the proximal end of the catheter sheath, the interior of the catheter head is hollow, and the optical fiber connector is located inside the catheter head;

[0050] The catheter dust cover is located at the proximal end of the catheter head and protects the catheter head.

[0051] In a specific embodiment, the catheter sheath comprises:

[0052] The length adjustment tube is located between the catheter shaft and the catheter head, and both ends of the length adjustment tube are respectively connected to the catheter shaft and the catheter head. The length of the length adjustment tube along the axial direction can be adjusted.

[0053] Beneficial Effects

[0054] The present application discloses a SS-OCT catheter structure with a small bending radius. It uses a linear optical lens to amplify the optical signal in the optical fiber, and then uses an optical cylindrical lens to collect the amplified optical signal, so that the optical signal in the optical fiber can be redirected to the desired angle by a steering reflector to the maximum extent. The size of the catheter core can be small enough to still perform image detection on human blood vessels, so that the catheter in the present application can enter thinner blood vessels for image diagnosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] Figure 1 It is a structural schematic diagram of the optical lens assembly of the present application;

[0056] Figure 2 It is a schematic diagram of the structure of the catheter core of the present application;

[0057] Figure 3 It is a schematic diagram of the catheter sheath structure of this application.

[0058] In the figure, 01, optical fiber; 02, linear optical lens; 03, optical cylindrical lens; 04, steering reflector; 05, lens protection tube; 06, optical signal; 11, optical lens assembly; 13, torque transmission tube; 14, nickel-titanium transmission tube; 15, optical fiber connector; 21, guide wire channel; 22, window tube; 23, catheter shaft; 25, length adjustment tube; 26, catheter head; 27, catheter dust cover. DETAILED DESCRIPTION

[0059] The present application is described in detail below. Although specific embodiments of the present application are shown, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

[0060] It should be noted that certain words are used in the specification and claims to refer to specific components. Those skilled in the art should understand that technicians may use different nouns to refer to the same component. This specification and claims do not use the difference in nouns as a way to distinguish components, but use the functional differences of components as the criterion for distinction. As mentioned throughout the specification and claims, "including" or "comprising" are open-ended terms and should be interpreted as "including but not limited to". The subsequent description of the specification is a preferred embodiment of the present application, but the description is based on the general principles of the specification and is not intended to limit the scope of the present application. The scope of protection of the present application shall be determined by the attached claims.

[0061] refer to Figure 1 and Figure 2 , the present application provides a SS-OCT catheter structure with a small bending radius. The catheter is composed of a catheter sheath and a catheter core located inside the catheter sheath;

[0062] In the field of interventional medicine, the end closer to the operator is defined as the "proximal end" and the end farther from the operator is defined as the "distal end"; for long objects, the direction parallel to the length extension direction is defined as the "axial direction"; and the direction surrounding the axial direction is defined as the "circumferential direction".

[0063] refer to Figure 1 and Figure 2 , the catheter core comprises:

[0064] An optical lens assembly 11, located at the distal end of the catheter core, for emitting and receiving an optical signal 06;

[0065] Optical fiber 01 is located at the proximal end of optical lens assembly 11 and connected to optical lens assembly 11, and can transmit optical signal 06 between optical lens assembly 11;

[0066] An optical fiber connector 15, located at the proximal end of the catheter core and connected to the optical fiber 01;

[0067] refer to Figure 3 , the catheter sheath comprises:

[0068] The window tube 22 is located outside the optical lens assembly 11 , and the optical signal 06 in the optical lens assembly 11 can pass through the window tube 22 .

[0069] When the SS-OCT catheter of the present application is used, the SS-OCT catheter is connected to an interferometer, which can generate an optical signal 06 for detection and can receive an optical signal 06 reflected by tissue.

[0070] refer to Figure 1 and Figure 2 The optical lens assembly 11 is connected to the optical fiber 01, and the optical fiber 01 can transmit the optical signal 06 for detection. After the optical signal 06 is transmitted from the optical fiber 01 to the optical lens assembly 11, the optical signal 06 will be processed by the optical lens assembly 11 and then emitted from the optical lens assembly 11.

[0071] refer to Figure 1 When the optical signal 06 is emitted from the optical lens assembly 11, it will irradiate the human tissue and then be reflected by the tissue. The optical signal 06 reflected by the tissue will be captured again by the optical lens assembly 11. The optical lens assembly 11 will then transmit the captured optical signal 06 to the optical fiber 01, and finally be transported to the interferometer by the optical fiber 01.

[0072] refer to Figure 2 The optical fiber connector 15 is used to connect the optical fiber 01 to the interferometer, so that the optical fiber 01 can be connected to the interferometer, and the optical signal 06 transmitted by the optical fiber 01 can be transmitted to the inside of the interferometer for information exchange.

[0073] refer to Figure 2 and Figure 3 The catheter sheath is arranged inside the catheter core, and the catheter sheath protects the catheter core. At the same time, the catheter sheath can also play a guiding role, and the catheter sheath can enter the human body, and then the catheter core will enter the human body along the catheter sheath for inspection.

[0074] refer to Figure 1 and Figure 3The window tube 22 is the part through which the optical signal 06 passes. When the catheter core is transported into the human body through the catheter sheath, the optical signal 06 in the catheter core will pass through the window tube 22. At the same time, the optical signal 06 reflected by the tissue will also pass through the window tube 22 and then enter the optical lens assembly 11. The reflected optical signal 06 is captured and processed by the optical lens, and then the optical signal 06 is transmitted to the optical fiber 01.

[0075] Preferably, the outer diameter of the window tube 22 is 0.2-0.8 mm, and the inner diameter is 0.1-0.2 mm;

[0076] More preferably, the window tube 22 has an outer diameter of 0.3-0.5 mm and an inner diameter of 0.16-0.25 mm.

[0077] Specifically, the outer diameter of the window tube 22 is 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, and 1.0 mm.

[0078] Specifically, the inner diameter of the window tube 22 is 0.1 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.2 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, and 0.25 mm.

[0079] refer to Figure 2 and Figure 3 , the SS-OCT catheter is connected to the interferometer, the optical fiber connector 15 is connected to the interferometer, so that the optical signal 06 in the interferometer can be transmitted to the optical fiber 01; the optical fiber 01 is connected to the optical lens assembly 11. The electrical signal in the interferometer is transmitted from the optical fiber 01 to the optical lens assembly 11, and then the optical lens assembly 11 irradiates the optical signal 06 onto the human tissue, and then part of the optical signal 06 is reflected by the human tissue, and the reflected optical signal 06 is received by the optical lens assembly 11 again to obtain the reflected optical signal 06, and the received reflected optical signal 06 is transmitted to the interferometer, and the interferometer processes the reflected optical signal 06 to realize the image detection of the tissue in the human body.

[0080] refer to Figure 2 and Figure 3 The window tube 22 is arranged on the outer circumference of the catheter core to protect the catheter core. At the same time, the window tube 22 is arranged on the outer circumference of the optical lens assembly 11, so that the optical lens assembly 11 can transmit the optical signal 06 from the window tube 22 and collect the reflected optical signal 06.

[0081] refer to Figure 2 and Figure 3 In the present application, the outer diameter of the window tube 22 is limited within a smaller range, so that the window tube 22 in the present application can enter the inside of the thinner blood vessels of the human body. Then the thinner cardiovascular or neurovascular vessels are effectively imaged for diagnosis. At the same time, in the present application, the various components of the SS-OCT catheter are reasonably arranged so that the SS-OCT catheter can still obtain high-quality images sufficient for diagnosis after the outer diameter is limited. Therefore, the SS-OCT catheter in the present application can enter the inside of thinner cardiovascular or neurovascular vessels while also obtaining high-quality images for diagnosis.

[0082] refer to Figure 1 , the optical lens assembly 11 comprises:

[0083] A steering reflector 04, located at the front end of the conduit core, is used to reflect or redirect the optical signal 06 to a desired direction;

[0084] refer to Figure 1 When the optical signal 06 is transmitted from the optical fiber 01, it will be irradiated onto the steering reflector 04, and then the optical signal 06 will be reflected by the steering reflector 04, so that the direction of the optical signal 06 will be turned, and then the optical signal 06 will be irradiated in the desired direction.

[0085] refer to Figure 1 , the optical signal 06 used for detection is transmitted forward along a straight line in the optical fiber 01, and when the optical signal 06 is detected inside the human tissue, the entire tissue needs to be detected to obtain a complete tissue image. Therefore, the flexibility of the optical fiber 01 is limited by the material and structure, and it is difficult to achieve bending within a small radius. In this application, the steering reflector 04 can adjust the angle to steer and reflect the optical signal 06, so that the optical signal 06 can be irradiated to more directions within a smaller radius.

[0086] refer to Figure 1 The steering reflector 04 can also steer the optical signal 06 reflected by the human tissue. After being captured by the optical lens group, the optical signal 06 reflected by the tissue will be steered again by the steering reflector 04, and then the optical signal 06 reflected by the tissue will enter the optical fiber 01 for transmission, thereby reducing the leakage of the optical signal 06 reflected by the tissue. At the same time, the use of the steering reflector 04 enables the catheter core to capture the optical signal 06 with a smaller size.

[0087] refer to Figure 1 , the optical cylindrical lens 03, located at the proximal end of the beam steering reflector 04, can effectively converge the optical signal 06;

[0088] After the optical signal 06 in the optical fiber 01 is transmitted to the optical cylindrical lens 03 , the optical cylindrical lens 03 can collect the optical signal 06 , reduce the scattering of the optical signal 06 , and further reduce the leakage of the optical signal 06 .

[0089] refer to Figure 1 When the light signal 06 irradiates the tissue, in order to enable the light signal 06 to irradiate the deeper tissue, the light signal 06 needs to have a certain intensity. At the same time, after the light signal 06 irradiates the tissue, the capture of the light signal 06 reflected by the tissue also needs to have a certain intensity. Therefore, before the light signal 06 irradiates the tissue, the optical cylindrical lens 03 is used to converge the light signal 06 to increase the intensity of the light signal 06, so that the light signal 06 has stronger penetration, and the light signal 06 reflected by the tissue is also easier to capture.

[0090] refer to Figure 1 The linear optical lens 02 is located at the proximal end of the optical cylindrical lens 03 and can amplify the optical signal 06 .

[0091] After the optical cylindrical lens 03 converges the light signal 06, the light signal 06 can penetrate deeper tissues, and at the same time, the intensity of the light signal 06 reflected by the tissue is increased. However, in the process of the light signal 06 piercing the tissue and being reflected by the tissue, most of the light signal 06 will still be lost, so the light signal 06 reflected by the tissue that can be captured is still weak. The linear optical lens 02 can amplify the light signal 06 reflected by the tissue, thereby improving the accuracy of tissue detection and obtaining high-quality images of tissue detection.

[0092] refer to Figure 1 The optical cylindrical lens 03, the linear optical lens 02, the optical fiber 01 and the steering reflector 04 are coaxially arranged.

[0093] refer to Figure 1 The optical signal 06 is transmitted along a straight line. Therefore, in order to reduce the loss and loss of the optical signal 06, the optical cylindrical lens 03 and the linear optical lens 02 are both arranged coaxially with the optical fiber 01 to reduce the loss of the optical signal 06 transmitted from the optical fiber 01.

[0094] refer to Figure 1 The steering reflector 04 is arranged at the farthest position and is also arranged coaxially with the optical fiber 01, so that the optical signal 06 can be transmitted to the steering reflector 04 along a straight line, and is reflected and turned by the steering reflector 04 at the farthest position, and then irradiated onto the human tissue for detection.

[0095] refer to Figure 1 The angle between the reflecting surface of the steering reflector 04 and the axial direction is 30-50 degrees;

[0096] Preferably, the angle between the reflection surface of the steering reflector 04 and the axial direction is 35-45 degrees.

[0097] Further preferably, the angle between the reflection surface of the steering reflector 04 and the axial direction is 37-41 degrees.

[0098] refer to Figure 1 , the length of the linear optical lens 02 is 200-800um;

[0099] Preferably, the length of the linear optical lens 02 is 300-500um;

[0100] Further preferably, the length of the linear optical lens 02 is 350-450 um.

[0101] Specifically, the length of the linear optical lens 02 is: 200um, 250um, 300um, 350um, 400um, 450um, 500um, 550um, 600um, 650um, 700um, 750um, 800um.

[0102] refer to Figure 1 , the length of the optical cylindrical lens 03 is 150-600um;

[0103] Preferably, the length of the optical cylindrical lens 03 is 200-450um;

[0104] Further preferably, the length of the optical cylindrical lens 03 is 270-330 um.

[0105] Specifically, the lengths of the optical cylindrical lens 03 are: 150um, 200um, 250um, 300um, 350um, 400um, 450um, 500um, 550um, 600um.

[0106] refer to Figure 1 A lens protection tube 05 is provided at the distal end of the catheter core, and the lens protection tube 05 is located at the distal end of the optical lens assembly 11.

[0107] refer to Figure 1The lens protection tube 05 is arranged at the most distal position of the catheter core. The lens protection tube 05 is used to protect and buffer the optical lens assembly 11. The distal end of the lens protection tube 05 is arranged to have a gradually decreasing cross-sectional area from the proximal end to the distal end, and the lens protection tube 05 has a certain elasticity. When the catheter core moves toward the distal end, the lens protection tube 05 can play a buffering role, so that when the catheter core receives an impact or resistance at the distal position, the lens protection tube 05 can completely or partially offset the impact force or resistance, thereby reducing the possibility of causing damage to the optical lens assembly 11.

[0108] refer to Figure 1 and Figure 2 , the optical fiber 01 is a standard single-mode optical fiber 01 for enhanced communication transmission.

[0109] In the present application, the sizes of the catheter core and the catheter sheath are relatively small, so a relatively small single-mode optical fiber 01 is selected to transmit the optical signal 06 .

[0110] In addition, in the present application, the transmission distance of the optical fiber 01 is relatively short, and it is only used for transmitting the optical signal 06 between the interferometer and the SS-OCT catheter, so the single-mode optical fiber 01 is sufficient.

[0111] refer to Figure 1 and Figure 2 , the catheter core further comprises:

[0112] The torque transmission tube 13 is used for transmitting torque so that the optical lens assembly 11 can rotate.

[0113] refer to Figure 2 and Figure 3 After the catheter core is delivered to the cardiovascular or neurovascular vessels through the catheter sheath, the optical signal 06 transmitted inside the optical fiber 01 will be transmitted from the optical lens assembly 11 and the window tube 22. When the optical lens assembly 11 processes the optical signal 06 for detection, the optical signal 06 for detection needs to have sufficient penetration, so that the detection of the tissue can be clearer. Therefore, the optical signal 06 for detection needs to be collected and processed, which makes the optical signal 06 for detection only detect a small range of tissue when it is transmitted from the optical lens assembly 11. In order to fully detect the tissue, when detecting the tissue, the torque transmission tube 13 can drive the components located at its distal end to rotate circumferentially, so that the optical lens assembly 11 rotates circumferentially, so that the optical signal 06 for detection can rotate circumferentially to detect the tissue in all aspects. Then a complete and clear high-quality image is obtained.

[0114] refer to Figure 2 , the catheter core comprises:

[0115] The nickel-titanium conductive tube 14 is disposed at the proximal end of the catheter core and is sleeved on the outside of the optical fiber 01 to protect the optical fiber 01 .

[0116] refer to Figure 2 , the nickel-titanium conductive tube 14 has a certain metal memory and a certain elasticity, the optical fiber 01 is located inside the nickel-titanium conductive tube 14, and the optical lens assembly 11 is arranged at the distal end of the nickel-titanium conductive tube 14. In order to have a certain turning ability, the optical fiber 01 has a low strength and a soft material, so it is difficult to directly use the optical fiber 01 to push the optical lens assembly 11 in the catheter sheath. The nickel-titanium conductive tube 14 also has a certain supporting effect. The nickel-titanium conductive tube 14 can push the optical lens assembly 11 so that the optical transparent assembly can smoothly enter the human body. At the same time, the nickel-titanium conductive tube 14 can also protect the optical fiber 01 and reduce the possibility of damage to the optical fiber 01.

[0117] refer to Figure 3 , the catheter sheath comprises:

[0118] The guidewire channel 21 is located at the distal end of the catheter sheath, and a guidewire for guiding can be placed inside the guidewire channel 21 .

[0119] The guide wire channel 21 is located at the distal end of the window tube 22. When the catheter sheath enters the human body, in order to reduce the damage of the catheter sheath to the human body, a guide wire is used to guide in front, and then the catheter sheath moves forward along with the guide wire.

[0120] The guidewire channel 21 has a hole for storing the guidewire. When the catheter sheath enters the human body, the guidewire is placed in the guidewire channel 21 and is located at the front end of the catheter sheath to guide the catheter sheath.

[0121] refer to Figure 3 During the operation, the guide wire is placed in the center of the catheter sheath and used to guide the pipeline. The catheter sheath enters the human body along with the guide wire. The guide wire is then removed from the catheter sheath, and the catheter core is transported into the catheter sheath to detect the human tissue and obtain images.

[0122] refer to Figure 3 The window tube 22 and the guide wire channel 21 are bonded with glue;

[0123] Preferably, the connection between the window tube 22 and the guide wire channel 21 is bonded with ultraviolet glue;

[0124] refer to Figure 3The window tube 22 is made of transparent material for the optical signal 06 to pass through, and the guide wire channel 21 is used to place the guide wire. Therefore, the window tube 22 and the guide wire channel 21 are made of different materials, and the guide wire channel 21 and the window tube 22 are connected by bonding.

[0125] It is further preferred to use ultraviolet glue for bonding to enhance the connection strength.

[0126] And after UV glue is cured by ultraviolet rays, the glue is more stable. At the same time, UV glue does not add harmful solvents, so it will not produce too many harmful substances to the human body during use after bonding and curing. This makes it safer to use UV glue in cases where surgery needs to be performed inside the human body.

[0127] Further preferably, the bonding length of the UV glue at the connection between the window tube 22 and the guide wire channel 21 is greater than 0.3 mm;

[0128] Further preferably, the bonding length of the UV glue at the connection between the window tube 22 and the guide wire channel 21 in the axial direction is greater than 0.5 mm.

[0129] Specifically, the bonding length of the UV glue is: 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, and 9mm.

[0130] refer to Figure 2 and Figure 3 During surgery, both the guide wire channel 21 and the window tube 22 need to enter the human body. In order to reduce the possibility of breakage between the guide wire channel 21 and the window tube 22 during surgery, the connection between the window tube 22 and the guide wire channel 21 should be strong enough to reduce the possibility of breakage between the window tube 22 and the guide wire channel 21. Therefore, when bonding the window tube 22 and the guide wire channel 21, the bonding length of the ultraviolet glue in the axial direction should be greater than 0.3 mm. Preferably, it should be greater than 0.5 mm.

[0131] When using ultraviolet glue to connect the guide wire channel 21 and the window tube 22, a lining wire is first inserted into the center of the guide wire channel 21 and the window tube 22. The lining wire can not only position the guide wire channel 21 and the window tube 22, but also be used to place ultraviolet glue to block the guide wire channel 21 and the window tube 22. Then, the window tube 22 and the guide wire channel 21 are connected using ultraviolet glue and hot melt technology. After the window tube 22 and the guide wire channel 21 are fixed, the lining wire is extracted to complete the connection between the guide wire channel 21 and the window tube 22.

[0132] refer to Figure 3 , the catheter sheath comprises:

[0133] The catheter shaft 23 is located at the proximal end of the window tube 22 and connected to the window tube 22 ; the optical fiber 01 is located inside the catheter shaft 23 .

[0134] The catheter shaft 23 is the main body of the catheter sheath, and is used to support the window tube 22 and the guidewire channel 21. The catheter shaft 23 can also support the catheter core and the optical fiber 01.

[0135] refer to Figure 2 and Figure 3 When the catheter sheath is placed inside the human body, the guidewire channel 21 is located at the farthest end of the catheter sheath, and the guidewire inside the guidewire channel 21 is used for guidance, and the rear catheter shaft 23 is used to provide thrust to the guidewire channel 21 and the guidewire. The catheter shaft 23 will push the guidewire and the guidewire channel 21 into the human body. And the catheter shaft 23 remains inside the human body, and the rear catheter core will enter the catheter shaft 23 to detect the human body.

[0136] refer to Figure 3 , the catheter shaft 23 includes a proximal catheter shaft and a distal catheter shaft, and the radial dimension of the proximal catheter shaft is greater than the radial dimension of the distal catheter shaft. The distal catheter shaft is connected to the window tube 22, so the radial dimension of the distal catheter shaft is smaller, so that the distal catheter shaft can enter into a thinner blood vessel along with the window tube 22. The radial dimension of the proximal catheter shaft is larger, so that the strength of the proximal catheter shaft is also greater, so that the proximal catheter shaft can withstand greater resistance, and further the proximal catheter shaft can provide greater thrust and fixing force for the distal catheter shaft, the window tube 22 and the guidewire channel 21, so that the window tube 22 can be more accurately positioned at the target position for detection.

[0137] On the other hand, the proximal catheter shaft can also support the catheter core. The larger proximal catheter shaft can provide greater support for the catheter core, thereby reducing the shaking of the catheter core in the human body. This makes the detection of the wire core clearer. The distal catheter shaft is set to a structure with a smaller radial dimension, so that the distal catheter shaft can enter the interior of a smaller blood vessel, thereby allowing the catheter core to enter a thinner blood vessel or vascular nerve for detection.

[0138] refer to Figure 3 , the catheter sheath comprises:

[0139] The transition sheath tube (not shown in the figure) is located between the window tube 22 and the catheter shaft 23, and the two ends of the transition sheath tube are connected to the window tube 22 and the catheter shaft 23 respectively.

[0140] The transition sheath is used to connect the window tube 22 and the catheter shaft 23. Specifically, the transition sheath is disposed between the window tube 22 and the distal catheter shaft.

[0141] The distal catheter shaft is used for supporting and protecting, and the window tube 22 is used for allowing the optical signal 06 to pass through. Therefore, it is difficult to connect the distal catheter shaft and the window tube 22 without damaging the window tube 22. Therefore, a transition sheath that is easy to connect with the window tube 22 and causes less damage to the window tube 22 is used, and then the transition sheath is connected to the distal catheter shaft.

[0142] refer to Figure 2 and Figure 3 , the catheter sheath comprises:

[0143] A catheter head 26 is located at the proximal end of the catheter sheath. The interior of the catheter head 26 is hollow, and the optical fiber connector 15 is located inside the catheter head 26;

[0144] The catheter head 26 is located at the root of the proximal end of the catheter sheath, and the catheter head 26 is cylindrical and connected to the catheter shaft 23 at the distal end of the catheter head 26. The catheter head 26 is also arranged on the outside of the optical fiber connector 15 and wraps the optical fiber connector 15 to protect the optical fiber connector 15.

[0145] In addition, the catheter head 26 can also play a connecting and limiting role. When the catheter core enters the catheter sheath, it will first enter from the catheter head 26. Then enter the catheter shaft 23. During surgery, the catheter head 26 is located outside the human body. And the optical fiber connector 15 of the catheter core will also be limited at the position of the catheter head 26.

[0146] refer to Figure 3The catheter dust cover 27 is located at the proximal end of the catheter head 26 and protects the catheter head 26.

[0147] When the catheter sheath is not in use, a catheter dust cover 27 is placed on the proximal end of the catheter head 26 to seal the proximal end of the catheter head 26, thereby reducing the possibility of dust entering the catheter sheath. Keep the catheter head 26 clean.

[0148] The catheter dust cover 27 is located at the end of the proximal end of the catheter sheath, and the catheter dust cover 27 is connected to the catheter head 26. The catheter dust cover 27 can protect the catheter head 26, thereby reducing the possibility of the catheter head 26 being damaged when receiving a force. In addition, the catheter dust cover 27 can withstand a greater extrusion force, reducing the possibility of the catheter head 26 being deformed when the catheter head 26 is squeezed.

[0149] refer to Figure 3 , the catheter sheath comprises:

[0150] The length adjustment tube 25 is located between the catheter shaft 23 and the catheter head 26 , and both ends of the length adjustment tube 25 are connected to the catheter shaft 23 and the catheter head 26 respectively. The length of the length adjustment tube 25 in the axial direction can be adjusted.

[0151] refer to Figure 3 The length adjustment tube 25 is a tube body that can change its own length. Preferably, the length adjustment tube 25 is two tubes nested with each other, and the two tubes can be sealed. Alternatively, the length adjustment tube 25 can be an elastic tube; or a bellows with a telescopic function. Here, the length adjustment tube 25 is used to adjust so that the window tube 22 located at the distal end of the catheter shaft 23 can be delivered to the target position, so that the catheter core located therein can detect the tissue. Improve the adaptability of the catheter sheath, and further, enable the catheter sheath to have the ability to cope with the inability to perform surgery due to insufficient length of the catheter sheath.

[0152] In the present application, the optical lens assembly 11 of the catheter core needs to be accurately placed at the position of the window tube 22 of the catheter sheath, so when the catheter core is installed in the catheter sheath, the length adjustment tube 25 can be used to enable the optical lens assembly 11 to be accurately transported to the position of the window tube 22. After the catheter core and the catheter sheath are installed, the length adjustment tube 25 will be fixed to reduce the change in the length of the catheter sheath and prevent the optical lens assembly 11 from deviating from the position of the window tube 22.

[0153] refer to Figure 3A developing ring (not shown in the figure) is also provided inside the guidewire channel 21, and the developing ring is used to develop the guidewire channel 21. After the catheter sheath enters the human body, the position of the developing ring can be detected to determine the position of the guidewire channel 21 and the window tube 22, and then the distal end of the catheter sheath is transported to the target position, and can be accurately positioned according to the developing ring.

[0154] In summary, the present application provides a SS-OCT catheter with a small bending radius. First, the optical lens assembly 11 is manufactured. Then, the linear optical lens 02, the optical cylindrical lens 03 and the steering reflector 04 are assembled in sequence, and then the optical fiber 01 of a length matching the interferometer is connected and ensured to be in a coaxial position. Then, the lens protection tube 05 is installed at the distal end of the catheter core. The nickel-titanium conductive tube 14 is sleeved on the outside of the optical fiber 01 to protect the optical fiber 01. Finally, the optical fiber connector 15 is installed on the optical fiber 01 and the nickel-titanium conductive tube 14. The assembly of the catheter core is completed.

[0155] Then assemble the catheter sheath, first assemble the developing ring into the appropriate position of the guidewire channel 21, and then assemble the assembled guidewire channel 21 and the window tube 22 together. Then use ultraviolet glue to bond and seal the window tube 22 and the guidewire channel 21. Then assemble the proximal end of the window tube 22 with the transition sheath tube, and then assemble the transition sheath tube with the distal catheter shaft. Then assemble the distal catheter shaft and the proximal catheter shaft. Finally, install the proximal catheter shaft on the catheter head 26. According to needs, use the catheter dust cover 27 to block the proximal opening of the catheter head 26.

[0156] Insert the assembled catheter into the catheter sheath, completing the assembly of the SS-OCT catheter with a small bending radius.

[0157] When the SS-OCT catheter is in use, the guide wire is first placed into the guide wire channel 21 of the catheter sheath, and then the guide wire is placed into the human body, and the catheter sheath enters the human body at the same time as the guide wire. The entry position of the catheter sheath is determined according to the developing ring located inside the guide wire channel 21. Until the catheter sheath is transported to the target position inside the human body. Then, the catheter core is inserted into the catheter sheath along the catheter head 26, and the optical lens assembly 11 of the catheter core is located at the window tube 22 position, so that the optical signal 06 can pass through the window tube 22 and irradiate the human tissue. Then, after the optical signal 06 passes through the tissue and part of the optical signal 06 is reflected by the tissue, it can be captured by the optical lens assembly 11 again through the window tube 22. Then the detection of the tissue is completed and the image inside the tissue is obtained. Subsequently, the torque conduction tube 13 is used to rotate the catheter core, and the inside of the tissue is fully detected by rotation.

[0158] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make modifications to the present embodiment without any creative contribution as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A SS-OCT catheter with a small bending radius, wherein: The catheter is composed of a catheter sheath and a catheter core located inside the catheter sheath; The catheter core comprises: An optical lens assembly, located at the distal end of the catheter core, for emitting and receiving optical signals; The optical fiber is located at the proximal end of the optical lens assembly and connected to the optical lens assembly, and is capable of transmitting optical signals between the optical lens assembly and the optical lens assembly; an optical fiber connector, located at the proximal end of the catheter core and connected to the optical fiber; The catheter sheath comprises: A window tube, artificially located outside the optical lens assembly, and an optical signal in the optical lens assembly can pass through the window tube; Preferably, the outer diameter of the window tube is 0.2-0.8 mm, and the inner diameter is 0.1-0.2 mm; Further preferably, the outer diameter of the window tube is 0.3-0.5 mm, and the inner diameter is 0.16-0.25 mm.

2. The catheter according to claim 1, wherein the optical lens assembly comprises: A steering reflector, located at the front end of the conduit core, is used to reflect or redirect the optical signal to a desired direction; The optical cylindrical lens is located near the beam steering reflector and can effectively focus the optical signal; The linear optical lens, located at the proximal end of the optical cylindrical lens, can amplify the optical signal. 3 . The catheter according to claim 1 , wherein the optical cylindrical lens, the linear optical lens, the optical fiber and the steering reflector are coaxially arranged.

4. The catheter according to claim 2, wherein the angle between the reflecting surface of the steering reflector and the axial direction is 30 to 50 degrees; Preferably, the angle between the reflecting surface of the steering reflector and the axial direction is 35 to 45 degrees; Further preferably, the angle between the reflecting surface of the steering reflector and the axial direction is 37 to 41 degrees.

5. The catheter according to claim 2, wherein the length of the linear optical lens is 200 to 800 um; Preferably, the length of the linear optical lens is 300-500um; Further preferably, the length of the linear optical lens is 350-450 um.

6. The catheter according to claim 2, wherein the length of the optical cylindrical lens is 150 to 600 um; Preferably, the length of the optical cylindrical lens is 200-450um; Further preferably, the length of the optical cylindrical lens is 270-330 um. 7 . The catheter according to claim 1 , wherein a lens protection tube is provided at the distal end of the catheter core, and the lens protection tube is located at the distal end of the optical lens assembly.

8. The catheter according to any one of claims 1 to 7, wherein the optical fiber is a standard single-mode optical fiber for enhanced communication transmission.

9. The catheter according to any one of claims 1 to 8, wherein the catheter core further comprises: The torque transmission tube is used for transmitting torque so that the optical lens assembly can rotate.

10. The catheter according to any one of claims 1 to 9, wherein the catheter core comprises: The nickel-titanium conductive tube is arranged at the proximal end of the catheter core, and the nickel-titanium conductive tube is sleeved on the outside of the optical fiber to protect the optical fiber.

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