Clinical operation radiography examination device for department of cardiology

Abstract

The invention provides a cardiology department clinical operation radiography examination device, and belongs to the technical field of medical instruments.The cardiology department clinical operation radiography examination device comprises an inner cavity cylinder, an injection component and a locking mechanism, and the injection component comprises a movable block, a lengthening component, an elastic element and a control hand part; the inner end of the lengthening part is fixedly connected with the movable block, the outer end of the lengthening part is fixedly connected with the control hand part, the inner end of the elastic element is fixedly connected with the movable block, the outer end of the elastic element is fixedly connected with the control hand part, and the movable block is tightly attached to the inner wall of the inner cavity cylinder. The movable block is made of a medical high polymer material and has a smooth surface; the variable-length component has a static state and an extension state, and when the variable-length component is in the static state, the problem that a traditional contrast agent injection device cannot achieve accurate flow control while the sealing performance is guaranteed can be solved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical instruments, and in particular, relates to a cardiology clinical surgery angiography examination device. Background Art

[0002] In the clinical diagnosis and treatment of cardiology, coronary angiography is an important diagnostic method. This technology injects contrast agent into the coronary artery, observes the vascular morphology under X-ray guidance, and evaluates the degree of vascular stenosis or occlusion. Traditional contrast agent injection devices have several significant problems in clinical applications.

[0003] First, the sealing structure of the existing device uses a simple rubber ring seal, which is prone to contrast agent leakage during high-pressure injection, which not only pollutes the surgical environment, but also affects the surgical effect. Secondly, the motion control of the syringe piston relies entirely on the operator's manual operation, which makes it difficult to achieve precise flow control, especially when slow and uniform injection is required, manual operation is difficult to maintain stability. Thirdly, the locking mechanism of the existing device is not designed reasonably, and accidental loosening may occur during the injection process, causing contrast agent reflux and affecting the contrast effect. In addition, most of the common angiography devices on the market currently use an integrated structure with a fixed piston rod length. This design is inconvenient to operate in different surgical positions, and the operator needs to frequently change the standing position to adapt to the injection angle. At the same time, the propulsion control mechanism of the existing device is relatively simple, usually only with simple friction damping, and the propulsion resistance cannot be adjusted according to the needs of different surgical stages, which makes it difficult to accurately control the injection rate of the contrast agent, especially in complex cases that require delicate operations.

[0004] The most prominent technical problem in the prior art is the inability to achieve precise flow control while ensuring sealing performance, which seriously restricts the improvement of surgical results. Summary of the invention

[0005] In view of this, the present invention provides a cardiology clinical surgery angiography examination device, which can solve the problem that the traditional contrast agent injection device cannot achieve accurate flow control while ensuring the sealing performance.

[0006] The present invention is achieved in that:

[0007] The present invention provides a cardiology clinical surgery angiography device, which comprises: an inner cavity tube, an injection component and a locking mechanism, wherein the injection component comprises a movable block, a variable length component, an elastic element and a control hand, the inner end of the variable length component is fixedly connected to the movable block, the outer end of the variable length component is fixedly connected to the control hand, the inner end of the elastic element is fixedly connected to the movable block, the outer end of the elastic element is fixedly connected to the control hand, the movable block is tightly fitted to the inner wall of the inner cavity tube, the movable block is made of medical polymer material and has a smooth surface; the variable length component has a static state and an extended state, when the variable length component is in the static state, the length of the variable length component is fixed, the control hand, the variable length component and the movable block move synchronously, when the variable length component is in the extended state, the variable length component can be freely extended and retracted; the outer surface of the inner cavity tube is provided with a threaded fitting portion, the threaded fitting portion is made of medical stainless steel material, and the threaded fitting portion is used for fitting and connecting with the control hand.

[0008] The technical effects of a cardiology clinical surgery angiography device provided by the present invention are as follows: The cardiology clinical surgery angiography device provided by the present invention effectively solves the contradiction between sealing performance and flow control in the prior art through innovative structural design. The device adopts a specially designed sealing ring and movable block combination structure to achieve dynamic adaptive sealing, and the sealing performance is not reduced under high pressure conditions, effectively preventing contrast agent leakage. Through the innovative design of the variable length component, the free adjustment of the piston rod length is achieved, so that the operator can maintain a comfortable operating posture in any surgical position. The locking mechanism of the present invention adopts a symmetrical clamping structure driven by a bidirectional screw, which can provide a stable and adjustable propulsion resistance, so that the contrast agent injection flow rate remains stable. Experimental data show that under the condition of a maximum injection pressure of 2.0MPa, the flow control accuracy of the device can reach ±3%, which is significantly better than the control accuracy of ±10% in the prior art. At the same time, the innovative movable block design keeps the propulsion force within a reasonable range, reducing the operator's operating fatigue. All components of the device of the present invention are made of medical grade materials, with good biocompatibility and strong reusability. After being used continuously for 100 times, the performance indicators of the device can still remain stable, and the service life significantly exceeds that of existing products. In addition, the assembly and maintenance of the device are also very convenient, which greatly reduces the use cost of medical institutions. In clinical applications, the device of the present invention has shown significant technical advantages, especially in operations of complex cases, it can provide more accurate contrast agent control and improve the success rate of operations. At the same time, the ergonomic design of the device has also been recognized by clinicians, reducing the operating burden of the operator.

[0009] On the basis of the above technical solution, the clinical surgery angiography examination device of the cardiology department of the present invention can also be improved as follows:

[0010] Among them, the locking mechanism includes an adjusting screw, two clamping assemblies and two sliding blocks. The two ends of the adjusting screw are respectively provided with an internal thread section and an external thread section. The spiral directions of the internal thread section and the external thread section are opposite. The sliding blocks are respectively threaded with the internal thread section and the external thread section. The two clamping assemblies are respectively fixed on the two sliding blocks and are symmetrically distributed with the axial center line of the inner cavity tube as the symmetry axis.

[0011] Furthermore, the clamping assembly includes a rubber body and a pressure plate. The outer surface of the inner cavity tube is provided with a mounting groove, the rubber body is arranged in the mounting groove, the rubber body is made of medical silicone material, the pressure plate is fixedly connected to the sliding block, and the pressure plate is in contact with the rubber body.

[0012] Furthermore, the variable length component is composed of multiple sleeves, and adjacent sleeves are coaxially sleeved. The sleeves are made of medical stainless steel material. The outer surface of the sleeve is provided with straight grooves, arc grooves and positioning protrusions. The straight grooves extend along the axial direction of the sleeve, and the arc grooves extend along the circumferential direction of the sleeve. The positioning protrusions cooperate with the straight grooves or arc grooves on the adjacent sleeves.

[0013] Furthermore, the end of the straight groove is connected to the arc groove, the straight groove and the arc groove have the same groove bottom depth, the groove bottom surface is polished, and the surface of the positioning protrusion is spherical.

[0014] Furthermore, the control hand includes an inner joint and an outer joint, the inner joint is rotatably connected to the variable length component, the outer joint is rotatably connected to the inner joint, the inner joint is provided with an internal thread matching the threaded mating part, the outer surface of the external joint is provided with anti-slip patterns, and the anti-slip patterns are distributed in a grid shape.

[0015] Furthermore, the cardiology clinical surgical angiography examination device also includes a delivery catheter, the proximal end of which is connected to the inner cavity tube, and the distal end of which is used to be inserted into the blood vessel. The delivery catheter is made of medical catheter material and is coated with a hydrophilic coating on the surface.

[0016] Furthermore, the movable block includes a sealing ring and a main body, the outer periphery of the main body is provided with an annular groove, the sealing ring is embedded in the annular groove, the sealing ring is made of medical rubber material, and the hardness value of the sealing ring is 60 to 80 Shore A.

[0017] Furthermore, the cross section of the main body is elliptical, the ratio of the short axis to the long axis of the main body is 0.8 to 0.9, the main body is injection molded using a medical polymer material, and the surface roughness of the main body is not greater than 0.4 microns.

[0018] Furthermore, the dimensional relationship between adjacent sleeves of the variable length component, the matching dimensional relationship between the movable block and the inner cavity tube, the compression deformation relationship of the sealing ring, the transition structure between the straight groove and the arc groove, and the spherical profile requirement of the positioning protrusion are respectively limited by the dimensional relationship limitation equation between adjacent sleeves of the variable length component, the matching dimensional relationship equation between the movable block and the inner cavity tube, the compression deformation relationship equation of the sealing ring, the transition curve equation between the straight groove and the arc groove, and the spherical profile requirement equation of the positioning protrusion.

[0019] 1. The equation defining the dimensional relationship between adjacent sleeves of variable length components:

[0020] D o =(1+α)D i ;

[0021] L o =βL i ;

[0022] α∈[0.02,0.05];

[0023] β∈[1.2,1.5];

[0024] Where, D o D is the inner diameter of the outer casing; i L is the outer diameter of the inner casing; o L is the outer sleeve length; i is the length of the inner sleeve; α is the radial clearance coefficient; β is the length ratio coefficient.

[0025] 2. The matching size relationship equation between the movable block and the inner cavity tube:

[0026]

[0027] P=EΔ / r o ;

[0028] 0.01mm≤Δ≤0.03mm;

[0029] Where Δ is the radial indentation; r o is the inner diameter of the inner cavity; r i is the outer diameter of the movable block; P is the contact pressure; E is the elastic modulus of the material.

[0030] 3. Compression deformation relationship equation of sealing ring:

[0031]

[0032] 20%≤(h 0 -h) / h 0 ≤35%;

[0033] Where, h is the height after compression; h 0is the original height; F is the compression force; A is the pressure-bearing area; λ is the compression coefficient.

[0034] 4. Transition curve equation of straight groove and arc groove:

[0035] y=ax n +bx n-1 ;

[0036]

[0037] n≥3;

[0038] R≥2mm;

[0039] In the formula, y is the ordinate of the transition curve; x is the abscissa; a and b are coefficients; n is the degree of the curve; and R is the radius of curvature.

[0040] 5. The spherical profile requirement equation of the positioning bump:

[0041]

[0042] δ≤0.01mm;

[0043] In the formula, z ij is the height of the measuring point; z 0 is the theoretical spherical height; δ is the allowable deviation; m, n are the number of measurement grids.

[0044] The design principles of these relationship-limiting equations are as follows:

[0045] 1. The relationship equation of the sleeve of the variable length component takes into account the sliding fit requirements, and avoids jamming by controlling the radial clearance; and ensures the telescopic stroke.

[0046] 2. The matching relationship of the movable block is based on the theory of elastic mechanics, and the nonlinear relationship between the pressing amount and the contact pressure is used to ensure the sealing.

[0047] 3. The deformation relationship of the sealing ring uses a power function to describe the compression characteristics, and the compression rate range is limited to ensure the sealing effect and service life.

[0048] 4. The groove transition adopts high-order curves to achieve smooth transition and avoids stress concentration through curvature control.

[0049] 5. The spherical profile uses discrete point deviation accumulation to control shape accuracy and ensure motion stability.

[0050] The method to obtain these parameters is:

[0051] 1.D o ,D i ,L o ,L i Measured by precision measuring tools;

[0052] 2. E is obtained through material tensile test;

[0053] 3.h 0 ,F,A is determined by compression test;

[0054] 4.z ij Scanned using a three-dimensional coordinate measuring machine.

[0055] Compared with the prior art, the beneficial effect of a cardiology clinical surgery angiography examination device provided by the present invention is that the cardiology clinical surgery angiography examination device provided by the present invention effectively solves the contradiction between sealing performance and flow control in the prior art through innovative structural design. The device adopts a specially designed sealing ring and movable block combination structure to achieve dynamic adaptive sealing, and the sealing performance is not reduced under high pressure conditions, effectively preventing contrast agent leakage. Through the innovative design of the variable length component, the free adjustment of the piston rod length is achieved, so that the operator can maintain a comfortable operating posture in any surgical position. The locking mechanism of the present invention adopts a symmetrical clamping structure driven by a bidirectional screw, which can provide a stable and adjustable propulsion resistance, so that the contrast agent injection flow rate remains stable. Experimental data show that under the condition of a maximum injection pressure of 2.0MPa, the flow control accuracy of the device can reach ±3%, which is significantly better than the control accuracy of ±10% in the prior art. At the same time, the innovative movable block design keeps the propulsion force within a reasonable range, reducing the operator's operating fatigue. All components of the device of the present invention are made of medical grade materials, with good biocompatibility and strong reusability. After being used continuously for 100 times, the performance indicators of the device can still remain stable, and the service life significantly exceeds that of existing products. In addition, the assembly and maintenance of the device are also very convenient, which greatly reduces the use cost of medical institutions. In clinical applications, the device of the present invention has shown significant technical advantages, especially in operations of complex cases, it can provide more accurate contrast agent control and improve the success rate of operations. At the same time, the ergonomic design of the device has also been recognized by clinicians, reducing the operating burden of the operator. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative labor.

[0057] Figure 1 The present invention is a schematic diagram of the structure of a cardiology clinical surgery angiography examination device;

[0058] In the accompanying drawings, the components represented by the reference numerals are listed as follows:

[0059] 10. Inner cavity tube; 11. Mounting groove; 20. Injection component; 21. Movable block; 211. Sealing ring; 212. Main body; 22. Variable length component; 221. Sleeve; 23. Elastic element; 24. Control hand; 241. Internal joint; 242. External joint; 30. Locking mechanism; 31. Adjusting screw; 32. Clamping assembly; 33. Sliding block; 40. Delivery catheter. DETAILED DESCRIPTION

[0060] In order to make the purpose, technical solution and advantages of the embodiments of the present invention more clear, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0061] like Figure 1 As shown, it is an embodiment of a cardiology clinical surgical angiography examination device provided by the present invention. In this embodiment, it includes: an inner cavity tube 10, an injection component 20 and a locking mechanism 30. The injection component includes a movable block 21, a variable length component 22, an elastic element 23 and a control hand 24. The inner end of the variable length component is fixedly connected to the movable block, the outer end of the variable length component is fixedly connected to the control hand, the inner end of the elastic element is fixedly connected to the movable block, and the outer end of the elastic element is fixedly connected to the control hand. The movable block is tightly fitted to the inner wall of the inner cavity tube, and the movable block is made of medical polymer material and has a smooth surface; the variable length component has a static state and an extended state. When the variable length component is in the static state, the length of the variable length component is fixed, the control hand, the variable length component and the movable block move synchronously, and when the variable length component is in the extended state, the variable length component can be freely extended and retracted; the outer surface of the inner cavity tube is provided with a threaded mating portion, the threaded mating portion is made of medical stainless steel material, and the threaded mating portion is used to be connected with the control hand.

[0062] Among them, in the above technical scheme, the locking mechanism includes an adjusting screw 31, two clamping assemblies 32 and two sliding blocks 33. The two ends of the adjusting screw are respectively provided with an internal thread section and an external thread section. The spiral directions of the internal thread section and the external thread section are opposite. The sliding blocks are respectively threaded with the internal thread section and the external thread section. The two clamping assemblies are respectively fixed on the two sliding blocks, and are symmetrically distributed with the axial center line of the inner cavity tube as the symmetry axis.

[0063] Furthermore, in the above technical solution, the clamping assembly includes a rubber body and a pressure plate. The outer surface of the inner cavity tube is provided with a mounting groove, and the rubber body is arranged in the mounting groove. The rubber body is made of medical silicone material. The pressure plate is fixedly connected to the sliding block, and the pressure plate is in contact with the rubber body.

[0064] Furthermore, in the above technical solution, the variable length component is composed of multiple sleeves 221, adjacent sleeves are coaxially sleeved, the sleeves are made of medical stainless steel material, and the outer surface of the sleeve is provided with straight grooves, arc grooves and positioning protrusions. The straight grooves extend along the axial direction of the sleeve, and the arc grooves extend along the circumferential direction of the sleeve. The positioning protrusions cooperate with the straight grooves or arc grooves on the adjacent sleeves.

[0065] Furthermore, in the above technical solution, the end of the straight groove is connected to the arc groove, the groove bottom depths of the straight groove and the arc groove are consistent, the groove bottom surface is polished, and the surface of the positioning protrusion is spherical.

[0066] Furthermore, in the above technical solution, the control hand includes an inner joint 241 and an outer joint 242, the inner joint is rotatably connected to the variable length component, the outer joint is rotatably connected to the inner joint, the inner joint is provided with an inner thread matching the threaded mating part, the outer surface of the outer joint is provided with anti-slip texture, and the anti-slip texture is distributed in a grid shape.

[0067] Furthermore, in the above technical solution, the cardiology clinical surgical angiography examination device also includes a delivery catheter 40, the proximal end of the delivery catheter is connected to the inner cavity tube, and the distal end of the delivery catheter is used to insert into the blood vessel. The delivery catheter is made of medical catheter material and the surface is coated with a hydrophilic coating.

[0068] Furthermore, in the above technical solution, the movable block includes a sealing ring 211 and a main body 212. The outer periphery of the main body is provided with an annular groove, and the sealing ring is embedded in the annular groove. The sealing ring is made of medical rubber material, and the hardness of the sealing ring is 60 to 80 Shore A.

[0069] Furthermore, in the above technical solution, the cross-section of the main body is elliptical, the ratio of the short axis to the long axis of the main body is 0.8 to 0.9, the main body is injection molded by medical polymer material, and the surface roughness of the main body is not greater than 0.4 microns.

[0070] Furthermore, in the above technical scheme, the dimensional relationship between adjacent sleeves of the variable length component, the matching dimensional relationship between the movable block and the inner cavity tube, the compression deformation relationship of the sealing ring, the transition structure between the straight groove and the arc groove, and the spherical contour requirement of the positioning protrusion are respectively limited by the dimensional relationship limitation equation between adjacent sleeves of the variable length component, the matching dimensional relationship equation between the movable block and the inner cavity tube, the compression deformation relationship equation of the sealing ring, the transition curve equation between the straight groove and the arc groove, and the spherical contour requirement equation of the positioning protrusion.

[0071] The present invention provides a cardiology clinical surgery angiography device, which is mainly composed of three parts: an inner cavity tube, an injection component and a locking mechanism. The specific structure of each part, its connection relationship and working principle are described in detail as follows.

[0072] 1. Inner cavity tube structure and its characteristics

[0073] The inner cavity tube, as the main frame of the device, is made of medical-grade stainless steel and has excellent mechanical strength and biocompatibility. The inner diameter of the inner cavity tube ranges from 8mm to 12mm, the wall thickness is 1.2mm to 1.5mm, and the overall length is 120mm to 150mm. The inner surface of the inner cavity tube is precision machined, and the surface roughness is controlled below Ra0.4 to ensure a stable and reliable sliding seal with the movable block. A specially designed threaded mating part is provided on the outer surface of the inner cavity tube. The threaded mating part is also made of medical stainless steel. The thread specification is M14×1.5, the thread length is 15mm to 20mm, and the thread surface is oxidized to improve wear resistance and rust resistance.

[0074] The proximal end of the inner tube is equipped with a standard medical interface for reliable connection with the delivery catheter. The interface adopts a conical design with a taper angle of 6 degrees. The interface surface is chrome-plated to ensure the reliability of the connection and facilitate disinfection and sterilization. The distal end of the inner tube is designed with an installation groove for installing the locking mechanism. The depth of the installation groove is 2mm to 3mm and the width is 5mm to 6mm. CNC machining technology is used to ensure machining accuracy.

[0075] 2. Structural design and working principle of injection parts

[0076] The injection part is the core part of the device, which consists of four main parts: the movable block, the variable length part, the elastic element and the control hand. The coordination between these parts directly affects the operating accuracy and reliability of the device.

[0077] The movable block is injection molded with medical polymer material (PEEK), and its cross section is designed to be elliptical, and the ratio of the short axis to the long axis is strictly controlled between 0.8 and 0.9. This design ensures both sealing performance and reduced friction resistance. The outer periphery of the movable block is provided with a precision-machined annular groove with a depth of 1.5mm to 2mm for installing the sealing ring. The sealing ring is made of medical silicone rubber material with a hardness of 60 to 80 Shore A, and its compression deformation must strictly follow the following relationship equation:

[0078] The compression deformation rate is controlled between 20% and 35%. The surface roughness of the movable block is precisely ground to ensure that it is no greater than 0.4 microns, which is crucial to ensure smooth movement and sealing reliability.

[0079] The variable length component adopts a telescopic structure design, which is composed of multiple coaxially connected medical stainless steel sleeves. The dimensional relationship between adjacent sleeves strictly follows the following mathematical relationship: D o =(1+α)D i, where the α value ranges from 0.02 to 0.05; the casing length ratio is: L o =βL i , where the β value ranges from 1.2 to 1.5. The outer surface of each sleeve is designed with a special guide mechanism, including a straight groove, an arc groove and a positioning bump. The straight groove extends axially, with a length of 15mm to 20mm and a groove depth of 1.5mm to 2mm; the arc groove extends circumferentially, with an arc length of 30 degrees to 45 degrees. The connection transition with the straight groove adopts a special curve design, and its mathematical expression is: y = ax n +bx n-1 , where n is not less than 3, and the curvature radius of the transition curve is not less than 2 mm.

[0080] The positioning bump is designed with a spherical structure, and its contour requirement is controlled by the following equation: The delta value is no more than 0.01mm. This precise structural design ensures the movement stability and positioning accuracy of the variable length component during the telescopic process. All sleeve surfaces are precisely polished and coated with a special medical lubricating coating to reduce the friction coefficient and improve durability.

[0081] The structural design of the control hand consists of two main parts: the inner joint and the outer joint. The inner joint and the variable length component adopt a special rotating connection structure to ensure operational flexibility; the outer joint and the inner joint are relative to each other through precision bearings. The inner joint is machined with an internal thread that matches the threaded mating part of the inner cavity tube. The thread accuracy grade is 6, and the matching clearance is controlled between 0.02mm and 0.04mm. The outer surface of the outer joint is designed with a special anti-slip pattern, which is distributed in a grid-like manner. The depth of the pattern is 0.3mm to 0.5mm to ensure the stability of the grip during the surgical operation.

[0082] 3. Precision design of locking mechanism

[0083] The locking mechanism adopts a bidirectional clamping structure design, which consists of an adjusting screw, two clamping components and two sliding blocks. The adjusting screw is the core component of the mechanism. It has an internal thread section and an external thread section at both ends. The thread specification is M8×0.75, but the spiral direction is opposite. This design can realize the synchronous adjustment function. The effective working length of the thread is 12mm to 15mm, and the surface is nitrided to improve wear resistance.

[0084] The sliding block and the threaded section are precisely matched, and the matching clearance is controlled between 0.01mm and 0.02mm. Each sliding block is provided with a mounting seat for fixing the clamping assembly. The two clamping assemblies are strictly symmetrically distributed about the axis of the inner cavity tube. This design ensures the uniformity of the clamping force. The clamping assembly consists of a rubber body and a pressure plate. The rubber body is made of medical silicone material with a hardness of 50 to 60 Shore A. The compression deformation characteristics conform to the nonlinear deformation theory. The pressure plate is made of stainless steel, and the surface is anodized to improve wear resistance and corrosion resistance.

[0085] 4. Technical characteristics of delivery catheter

[0086] The delivery catheter of this device is made of special medical catheter materials with good biocompatibility and mechanical properties. The inner diameter of the catheter is 2mm to 3mm, the wall thickness is 0.3mm to 0.4mm, and the surface of the catheter is coated with a special hydrophilic coating with a thickness controlled between 5μm and 8μm. This coating can significantly reduce the friction between the catheter and the blood vessel wall, improving the safety and smoothness of the surgical operation. The proximal end of the catheter is connected to the inner cavity tube with a standard medical connector to ensure the reliability and sealing of the connection. The distal end of the catheter undergoes a special heat treatment process to form a soft guide head for easy navigation in the blood vessel.

[0087] 5. Performance indicators and working characteristics of the device

[0088] This device has shown excellent performance characteristics in practical applications. The sealing performance between the movable block and the inner cavity tube is guaranteed by precise dimensional matching, and the matching relationship follows the following equation: The radial pressing amount Δ is controlled between 0.01mm and 0.03mm. This precise fit ensures good sealing performance without causing excessive movement resistance. The variable length component switches between the static state and the extended state smoothly and reliably, with the maximum extended length reaching more than 3 times the original length, and can remain stable in any position. The maximum clamping force of the locking mechanism can reach 200N, ensuring reliable sealing during the injection of high-pressure contrast agents.

[0089] All surfaces of the device that come into contact with the human body have undergone special surface treatment and coating processes to ensure good biocompatibility. All parts are made of medical-grade materials and can withstand multiple high-temperature and high-pressure sterilizations, with a service life of more than 200 times. In clinical applications, the device has demonstrated excellent operating performance and reliability, greatly improving the efficiency and safety of cardiology angiography.

[0090] Embodiment 1:

[0091] The inner cavity tube in this embodiment is made of medical 316L stainless steel material, with an inner diameter of 12 mm, a wall thickness of 1.5 mm, and a total length of 200 mm. The outer surface of the inner cavity tube is precision turned, and the surface roughness Ra value is not greater than 0.4 microns. Two threaded fitting parts are set on the outer surface of the inner cavity tube, respectively located 30 mm away from the two ends of the inner cavity tube. The pitch of the threaded fitting part is 1.5 mm, and the thread standard adopts M14×1.5 fine thread. The end of the inner cavity tube is chamfered, the chamfer angle is 45 degrees, and the chamfer width is 0.5 mm.

[0092] The movable block is injection molded with medical grade PEEK material. The main body has a major axis of 11.9 mm, a minor axis of 9.8 mm and a length of 25 mm. An annular groove is set on the outer periphery of the movable block. The width of the annular groove is 2 mm and the depth is 1.5 mm. The sealing ring is made of medical silicone rubber with a cross-sectional diameter of 2 mm and a hardness of 70 Shore A. When the sealing ring is assembled in the annular groove, an 8% pre-compression is generated to ensure a good sealing effect. The surface of the movable block has been specially treated, and the sliding friction coefficient between it and the inner cavity tube is not more than 0.15.

[0093] The variable length component is composed of 5 sleeves, all of which are made of 316L stainless steel precision pipes. The matching clearance values ​​of adjacent sleeves are set as shown in the following table:

[0094] Table 1 Casing size

[0095]

[0096]

[0097] Each section of the casing is provided with 4 straight grooves and 1 annular groove. The straight grooves are evenly distributed along the axial direction, with a groove width of 1 mm and a groove depth of 0.8 mm. The annular groove is located in the middle of the casing, with the same groove width as the straight groove, and the transition zone between the two adopts an arc transition with a radius of 2 mm. The positioning bump is made of 316L stainless steel material, and its shape is a spherical crown with a spherical crown radius of 0.9 mm and a height of 0.7 mm. All grooves and bump surfaces are polished, and the surface roughness Ra value is controlled within 0.2 microns.

[0098] The control hand is divided into two parts: the inner joint and the outer joint. The inner joint is injection molded with medical-grade POM material, and its interior is processed with M14×1.5 threads for connecting with the threaded mating part of the inner cavity tube. The outer joint is also made of medical-grade POM material, and the outer surface is provided with a grid-like anti-slip pattern with a depth of 0.3 mm and a grid spacing of 2 mm. The inner joint and the outer joint are connected by a circlip structure, which allows relative rotation but cannot be separated axially.

[0099] The total length of the adjustment screw of the locking mechanism is 80 mm and is made of 316L stainless steel. The two ends of the adjustment screw are respectively machined with M8×1 left-handed thread and M8×1 right-handed thread, and the thread length is 25 mm. The two sliding blocks are made of medical-grade POM material and have dimensions of 20×15×10 mm. The sliding block is machined with a threaded hole that matches the adjustment screw, and the backlash of the thread matching pair is controlled within 0.02 mm.

[0100] The rubber body of the clamping assembly is made of medical silicone with a hardness of 50 Shore A and dimensions of 15×10×5 mm. The pressure plate is made of 316L stainless steel sheet with a thickness of 1 mm. The pressure plate is fixed to the sliding block by two M3 screws with a tightening torque of 0.4 Nm. The depth of the mounting groove is 4.8 mm, slightly less than the thickness of the rubber body, so that the rubber body has a pre-compression of 0.2 mm.

[0101] The delivery catheter is made of medical-grade polyurethane material, with an inner diameter of 4 mm, a wall thickness of 0.5 mm, and a total length of 1500 mm. The surface of the catheter is coated with a hydrophilic coating with a thickness of 5 microns. The proximal end of the catheter is connected to the inner cavity tube with a Luer lock connector to ensure connection reliability. The distal end of the catheter undergoes a special thermoforming process to form a tapered structure for easy insertion into the blood vessel.

[0102] In actual application, contrast agent is first injected through the inner tube. When contrast agent is loaded, the movable block is at the farthest end of the inner tube, and the control hand is fully engaged with the inner tube through the thread. The adjustment screw of the locking mechanism is in the middle position, and the clamping assembly applies appropriate pressure to the movable block. After no leakage is observed, the distal end of the delivery catheter is inserted into the patient's blood vessel.

[0103] When injecting contrast medium, turn the adjusting screw clockwise to move the two sliding blocks toward the middle at the same time, and the clamping assembly gradually releases the pressure on the movable block. At this time, the variable length component is in a free state, and the control hand can slowly push it forward. By controlling the anti-slip texture on the hand, the operator can accurately control the pushing speed and force. During the injection process, the sealing ring always maintains a reliable seal with the inner wall of the inner cavity to prevent contrast medium leakage.

[0104] Clinical verification shows that the device has the following advantages in actual use: reliable sealing performance, no leakage under the maximum injection pressure of 2.0MPa; stable propulsion force, through the pre-compression design of the clamping component, the propulsion resistance is kept in the range of 5 to 8 Newtons; precise operation, the minimum controllable injection volume is 0.1 ml, and the injection flow error does not exceed 3%. After 100 consecutive uses, the size and performance of each component did not change significantly, indicating that the device has good durability.

[0105] The main performance indicators of the device are shown in the following table:

[0106] Table 2 Device performance data

[0107]

[0108]

[0109] The key materials used were tested for biocompatibility, and the results showed that all materials met the requirements of ISO10993 standard, and the results of cytotoxicity, sensitization and irritation tests were all negative. The material performance test data are shown in the following table:

[0110] Table 3 Material performance test data

[0111] Material Category Test items Test Results Standard requirements 316L Stainless Steel tensile strength 580MPa ≥485MPa PEEK Materials Flexural modulus 4.1GPa ≥3.8GPa Medical silicone rubber Tensile Strength 8.5MPa ≥7.0MPa Medical grade POM Impact strength <![CDATA[85KJ / m 2 ]]> <![CDATA[≥80KJ / m 2 ]]> Polyurethane catheter Elongation at break 450％ ≥400％

[0112] During the production process, key dimensions are fully inspected using precision testing equipment to ensure stable and reliable product quality. The main test items and their results are shown in the following table:

[0113] Table 4 Test items and their results

[0114] Test items Nominal value Measured value Permissible deviation Inner diameter of inner tube 12.000mm 12.003mm ±0.005mm Outer diameter of movable block 11.900mm 11.897mm ±0.004mm Thread accuracy Level 6 Level 6 ≤Level 6 Surface roughness Ra0.4 Ra0.38 ≤Ra0.4 Coaxiality 0.02mm 0.018mm ≤0.02mm Cylindricity 0.01mm 0.008mm ≤0.01mm

[0115] During the clinical trial phase, the device completed 200 coronary angiography examinations, with a 100% success rate. The device operated smoothly during the operation, without any jamming or leakage. The angiography was clear, the contrast agent injection flow was uniform, and no contrast agent reflux occurred. Operators generally reported that the device had good controllability and safety, especially in complex cases that required precise control of the injection rate, showing obvious advantages.

[0116] After clinical verification, the device can meet various technical requirements of angiography in cardiology surgery, and has the characteristics of reasonable structure, simple operation, reliable performance, etc. Through reasonable structural design and material selection, it solves the problems of poor sealing and inconvenient operation in the use of traditional devices, providing better technical support for clinical surgery.

[0117] The following describes in detail the method of using the cardiology clinical surgery angiography examination device.

[0118] 1. Preparation before use:

[0119] 1. Cleaning and disinfection: All parts of the device are treated using the standard medical device disinfection process, with the disinfection temperature controlled at 134 degrees Celsius for 4 minutes to ensure that all parts are completely disinfected and sterilized. The device is assembled after cooling, and the assembly process must be completed in a sterile environment.

[0120] 2. Sealing test: Inject 20 ml of saline solution for sealing test and check whether there is leakage between the movable block and the inner tube. Turn the control hand to check whether the telescopic and locking functions of the variable length component are normal. Observe the working status of the clamping assembly and confirm that the locking mechanism is reliable.

[0121] 3. Catheter connection: Connect the delivery catheter to the inner tube with the Luer lock connector. After the connection is completed, gently pull to confirm that the connection is firm. The other end of the catheter is temporarily closed and ready for exhaust.

[0122] 2. Contrast agent loading:

[0123] 1. Rotate the control hand to the farthest end of the inner tube so that the movable block is in the starting position. Adjust the locking mechanism to ensure that the movable block is securely fixed.

[0124] 2. Slowly inject the contrast agent preheated to 37 degrees Celsius from the front end of the inner tube, avoiding bubbles during the injection process. After the injection is completed, gently shake the device to allow the bubbles to gather at the front end.

[0125] 3. Start the front end of the delivery catheter and slowly push the movable block until the contrast agent fills the entire pipeline system, ensuring that there are no bubbles remaining in the system.

[0126] 3. Surgical operation:

[0127] 1. Preparation for contrast agent injection: The operator chooses a suitable standing position and adjusts the length of the variable length component to make the operating posture comfortable. Turn the end of the variable length component clockwise to lock all the cannulas in the target position.

[0128] 2. Pressure adjustment: According to the surgical requirements, adjust the knob of the locking mechanism so that the clamping assembly applies appropriate pressure to the movable block. In standard operation, the pushing resistance should be controlled within the range of 5 to 8 Newtons.

[0129] 3. Contrast injection: Push the control hand slowly and evenly to control the injection rate. During the injection process, closely observe the pressure gauge reading to ensure that it does not exceed 2.0MPa. If you need to pause the injection, you can lock the position of the movable block at any time.

[0130] 4. Notes:

[0131] 1. Key points of operation: The injection rate of contrast agent should be uniform, and avoid sudden acceleration or deceleration; pay close attention to the patient's reaction and be ready to adjust the injection parameters at any time; regularly check whether all parts of the device are loose or abnormal.

[0132] 2. Safety matters: Strictly implement aseptic operation procedures; ensure that all locking mechanisms are reliable; regularly check the sealing performance; observe whether there is reflux of contrast agent.

[0133] 3. Troubleshooting: If leakage is found, stop operation immediately and check the status of the sealing ring; if the propulsion force is abnormal, check whether the locking mechanism is properly adjusted; if the catheter resistance is found to increase, forced injection is prohibited.

[0134] 5. Maintenance after use:

[0135] 1. Cleaning procedure: disassemble all parts and remove surface residues; rinse all parts with special cleaning fluid; ultrasonic cleaning for 10 minutes; rinse repeatedly with purified water.

[0136] 2. Storage requirements: Wipe the parts dry and pack them separately; store in a dry and ventilated environment; avoid direct sunlight and high temperature environment; check the status of the parts regularly.

[0137] 3. Regular maintenance: Replace the sealing ring after every 50 uses; check whether the threaded parts are intact; confirm that the locking mechanism is flexible and reliable; and verify the accuracy of the pressure gauge.

[0138] Through standardized operation and regular maintenance, the device can continue to maintain good performance and provide reliable protection for clinical diagnosis and treatment.

[0139] It should be noted that the variables involved in the present invention are explained in detail as shown in Table 5:

[0140] Table 5 Explanation of variables

[0141] <![CDATA[D o :Inner diameter of outer casing]]> <![CDATA[D i :Inner casing outer diameter]]> <![CDATA[L o :Outer sleeve length]]> <![CDATA[L i :Inner casing length]]> α: Radial clearance coefficient β: length scale factor Δ: Radial press-in amount <![CDATA[r o :Inner diameter of inner tube]]> <![CDATA[r i :Outer diameter of movable block]]> P: Contact pressure E: Material elastic modulus h: Height after compression <![CDATA[h 0 : Original height]]> F: Compression force A: Pressure bearing area λ: Compression factor y: vertical coordinate of transition curve x: horizontal coordinate a,b: coefficients R: Radius of curvature n: curve number <![CDATA[z ij :Measurement point height value]]> <![CDATA[z 0 :Theoretical spherical height]]> δ: allowable deviation m,n: number of measurement grids

[0142] Specifically, the principle of the present invention is as follows: first, in the design of the sealing system, a sealing ring structure with adaptive characteristics is adopted. When the injection pressure increases, the sealing ring will produce radial deformation under the pressure, so that the contact pressure between the sealing ring and the wall of the inner cavity tube increases synchronously, forming a pressure-responsive sealing effect. This dynamic sealing principle ensures that reliable sealing performance can be maintained under different pressure conditions. Secondly, the variable length component adopts an innovative sleeve combination structure, and the organic combination of length adjustment and locking functions is achieved through the special design of straight grooves and arc grooves. When the sleeve is rotated to a specific angle, the protrusion will turn from the straight groove to the arc groove, and the relative position between adjacent sleeves is locked. This mechanical principle ensures both the flexibility of adjustment and the reliability of locking. In terms of material selection, considering the special requirements of medical devices, all metal parts are made of 316L stainless steel, which has excellent corrosion resistance and mechanical strength and can withstand repeated disinfection and sterilization. The design of the locking mechanism adopts the principle of mechanical balance, and drives two symmetrically arranged clamping components through a bidirectional screw to ensure uniform distribution of the clamping force. This design not only improves the reliability of locking, but also avoids component deformation caused by local stress concentration. The rubber body in the clamping assembly uses a specially formulated medical silicone, and its hardness and elastic modulus are optimized to provide a linear clamping force response, which is conducive to the precise control of the propulsion resistance. The design of the control hand fully considers the principles of ergonomics, and improves the comfort and stability of operation through reasonable size and anti-slip texture design. The rotating connection design of the internal and external joints solves the problem of relative rotation during the propulsion process and avoids the generation of torsional stress. The structural design of the entire device follows the basic principles of uniform stress distribution, stable motion resistance, and convenient and reliable operation. The dimensional relationship and matching accuracy between each component are strictly calculated and optimized. In general, the present invention successfully solves the core technical problems of the angiography device in terms of sealing performance and flow control through a number of innovative technical solutions, providing more reliable technical support for clinical surgery. The design concept and technical principle of the device have a profound theoretical foundation and practical basis, which fully verifies its technical feasibility and practical value.

[0143] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. A cardiology clinical surgery angiography examination device, characterized in that: include: An inner cavity tube, an injection component and a locking mechanism, wherein the injection component comprises a movable block, a variable length component, an elastic element and a control hand, the inner end of the variable length component is fixedly connected to the movable block, the outer end of the variable length component is fixedly connected to the control hand, the inner end of the elastic element is fixedly connected to the movable block, the outer end of the elastic element is fixedly connected to the control hand, the movable block is tightly fitted to the inner wall of the inner cavity tube, and the movable block is made of medical polymer material and has a smooth surface; the variable length component has a static state and an extended state, when the variable length component is in the static state, the length of the variable length component is fixed, the control hand, the variable length component and the movable block move synchronously, and when the variable length component is in the extended state, the variable length component can freely retract and retract; the outer surface of the inner cavity tube is provided with a threaded mating portion, the threaded mating portion is made of medical stainless steel material, and the threaded mating portion is used to be mated and connected with the control hand.

2. A cardiology clinical surgery angiography examination device according to claim 1, characterized in that: The locking mechanism includes an adjusting screw, two clamping assemblies and two sliding blocks. The two ends of the adjusting screw are respectively provided with an internal thread section and an external thread section. The spiral directions of the internal thread section and the external thread section are opposite. The sliding blocks are respectively threadedly matched with the internal thread section and the external thread section. The two clamping assemblies are respectively fixed on the two sliding blocks and are symmetrically distributed with the axis of the inner cavity tube as the axis of symmetry.

3. A cardiology clinical surgery angiography examination device according to claim 2, characterized in that: The clamping assembly includes a rubber body and a pressure plate. The outer surface of the inner cavity tube is provided with a mounting groove. The rubber body is arranged in the mounting groove. The rubber body is made of medical silicone material. The pressure plate is fixedly connected to the sliding block, and the pressure plate is in contact with the rubber body.

4. A cardiology clinical surgery angiography examination device according to claim 3, characterized in that: The variable length component is composed of a plurality of sleeves, and adjacent sleeves are coaxially sleeved. The sleeves are made of medical stainless steel material. The outer surface of the sleeve is provided with a straight groove, an arc groove and a positioning protrusion. The straight groove extends along the axial direction of the sleeve, and the arc groove extends along the circumferential direction of the sleeve. The positioning protrusion cooperates with the straight groove or arc groove on the adjacent sleeve.

5. A cardiology clinical surgery angiography examination device according to claim 4, characterized in that: The end of the straight groove is communicated with the arc groove, the straight groove and the arc groove have the same groove bottom depth, the groove bottom surface is polished, and the surface of the positioning protrusion is spherical.

6. A cardiology clinical surgery angiography examination device according to claim 5, characterized in that: The control hand includes an inner joint and an outer joint, the inner joint is rotatably connected to the variable length component, the outer joint is rotatably connected to the inner joint, the inner joint is provided with an inner thread matching the threaded mating part, the outer surface of the outer joint is provided with anti-slip patterns, and the anti-slip patterns are distributed in a grid shape.

7. A cardiology clinical surgery angiography examination device according to claim 6, characterized in that: The cardiology clinical surgery angiography device also includes a delivery catheter, the proximal end of which is connected to the inner cavity tube, and the distal end of which is used to be inserted into the blood vessel. The delivery catheter is made of medical catheter material and is coated with a hydrophilic coating on the surface.

8. A cardiology clinical surgery angiography examination device according to claim 7, characterized in that: The movable block comprises a sealing ring and a main body. The outer periphery of the main body is provided with an annular groove, and the sealing ring is embedded in the annular groove. The sealing ring is made of medical rubber material, and the hardness value of the sealing ring is 60 to 80 Shore A.

9. A cardiology clinical surgery angiography examination device according to claim 8, characterized in that: The cross section of the main body is elliptical, the ratio of the short axis to the long axis of the main body is 0.8 to 0.9, the main body is injection molded by medical polymer materials, and the surface roughness of the main body is not greater than 0.4 microns.

10. The cardiology clinical surgery angiography examination device according to claim 9, characterized in that: The dimensional relationship between adjacent sleeves of the variable length component, the matching dimensional relationship between the movable block and the inner cavity tube, the compression deformation relationship of the sealing ring, the transition structure between the straight groove and the arc groove, and the spherical contour requirement of the positioning protrusion are respectively defined by the dimensional relationship definition equation between adjacent sleeves of the variable length component, the matching dimensional relationship equation between the movable block and the inner cavity tube, the compression deformation relationship equation of the sealing ring, the transition curve equation between the straight groove and the arc groove, and the spherical contour requirement equation of the positioning protrusion.

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