Non-destructive diagnosis and treatment system

By designing a damage-free diagnostic and treatment system, using energy platform, visual tube lens and mesh basket components, combined with umbrella and directional assembly, the problem of instrument damage during lithotripsy surgery is solved, and damage-free and rapid lithotripsy and stone extraction operations are achieved, improving the safety and success rate of the surgery.

CN120345989APending Publication Date: 2025-07-22WUHAN HECHANG HUITONG MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202510507289.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-04-22
Publication Date
2025-07-22

AI Technical Summary

Technical Problem

In existing lithotripsy surgery, the damage to the human cavity by the instrument, including caloric and mechanical damage, leads to prolonged surgical time and increased patient pain, and it is difficult for the existing technology to quickly establish lithotripsy channels and accurately find stones.

Method used

Design a damage-free diagnostic and treatment system, including an energy platform, visual tube lens, adjustable energy delivery catheter and mesh basket assembly, combined with an umbrella-shaped assembly and directional adjustment assembly, to achieve damage-free operation, avoid high heat and mechanical damage, and quickly find and remove stones through visualization and directional adjustment functions.

Benefits of technology

The damage-free gravel and stone extraction process is achieved, which shortens the surgical time, avoids damage to the cavity by the instrument, and improves the safety and success rate of the surgery.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a non-destructive diagnosis and treatment system which comprises an energy platform, a display platform, a visual tube mirror, a camera shooting assembly, a mesh basket assembly, an umbrella-shaped assembly, a direction adjusting assembly and the like, the umbrella-shaped assembly is passively opened when the mesh basket assembly passes through the umbrella-shaped assembly, and the umbrella-shaped assembly is automatically closed when the mesh basket assembly retracts into the visual tube mirror. According to the non-destructive diagnosis and treatment system, through the arrangement of the energy platform (host), the visual tube lens, the mesh basket, the matched tools and the like, non-destructive human body natural cavity operation can be achieved, and the situation that organs or tissues in a human body cavity are damaged by instruments in the visual diagnosis, stone breaking and stone removing processes is avoided; the injury to human tissues caused by instant high heat in the lithotripsy process is avoided, and the safety of lithotripsy operation is favorably improved. The non-injury diagnosis and treatment system can be applied to the non-injury urinary lithotripsy direction and the non-injury ERCP direction, and damage and function loss caused by cutting open sphincter to organs are avoided.
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Description

Technical Field

[0001] The present invention relates to the technical fields of lithotripsy instruments and ERCP surgery techniques without damaging organs, and particularly relates to a non-invasive diagnosis and treatment system. Background Art

[0002] Whether it is electrohydraulic lithotripsy, laser lithotripsy or other types of in-vivo lithotripsy, more or less damage will be caused to the human tissue cavity during the lithotripsy process, mainly including heat and mechanical damage. These damages are not limited to the high-temperature damage caused by the high heat and high-temperature steam at the moment of lithotripsy, the frictional damage caused by the movement of the stone to the tissue, and the damage caused by the tube body, tube end, etc. during the insertion or extraction of the endoscope. Due to the occurrence of these damages, the difficulty of stone extraction is more or less increased, and it will also increase the pain level of the patient and the time for subsequent physical recovery, as well as the risk of iatrogenic diseases.

[0003] For example, during the implementation of ERCP surgery, as shown in the attached Figure 18 instructions, when the endoscope reaches the duodenum, it is necessary to control the lithotripsy electrode and the basket, etc. to enter the hepatopancreatic ampulla and common bile duct through the small channel at the duodenal papilla, and finally reach the gallbladder. Since the small channel of the hepatopancreatic ampulla at the duodenal papilla is not along the direction of the endoscope, the endoscope comes from above the duodenum and cannot directly face the small channel at the duodenal papilla, and the diameter of this small channel is small, and it is difficult for the lithotripsy-related instruments to be adjusted and enter. Therefore, the duodenal papilla will be incised to facilitate the entry of the instruments. This practice has actually damaged the sphincter of the papilla at this place, which is irreparable in the later stage. At least, it will cause limited sphincter contraction function, and at worst, it will cause the loss of function, and even the gallbladder needs to be removed, resulting in repeated biliary tract infections and iatrogenic diseases.

[0004] Another example is during the lithotripsy process of the urinary system. The laser may burn the human tissue, and the high-temperature steam generated instantaneously during laser lithotripsy will also burn the human tissue. This kind of trauma is also difficult to recover, and it will also cause ureteral stricture, bringing great pain and postoperative life impact to the patient. For example, holmium laser lithotripsy of the ureter causes ureteral injury, ureteral injury causes ureteral stricture, and ureteral stricture requires the placement of a ureteral stent, which will eventually lead to ureteral atresia and thus renal function loss.

[0005] In addition, in these surgeries, the time that takes up the most of the operation is not the lithotripsy time, but the time consumed for establishing the lithotripsy channel, finding the stone, and clearing the stone, etc. If the lithotripsy channel can be established quickly, and the stone can be accurately and quickly found and restricted, and the stone can be quickly cleared after lithotripsy, then the operation time can be greatly shortened, and iatrogenic diseases can be fundamentally solved. Summary of the Invention

[0006] The object of the present invention is to provide a non-invasive diagnosis and treatment system in view of the problems existing in the prior art.

[0007] To achieve the above object, the technical solution adopted by the present invention is:

[0008] A non-invasive diagnosis and treatment system, at least including an energy platform and a display platform, and an adjustable energy delivery catheter connected to the energy platform, and a visual endoscope connected to the display platform. At least an axially penetrating first channel and a second channel are provided in the visual endoscope. The cross-sectional dimension of the first channel is larger than that of the second channel. At least a cable channel and a water channel are provided in the second channel. A camera assembly is provided in the cable channel. A movable and adjustable hollow basket assembly is provided in the first channel. The adjustable energy delivery catheter axially penetrates through the hollow channel of the basket assembly. An openable and closable umbrella-shaped assembly is further provided at the end of the visual endoscope. When the basket assembly passes through the umbrella-shaped assembly, the umbrella-shaped assembly is passively opened. When the basket assembly retracts into the visual endoscope, the umbrella-shaped assembly closes itself.

[0009] The present non-invasive diagnosis and treatment system can realize non-invasive surgical operations on human bodies or animals, avoid damage to tissues in the human body cavity caused by instruments during visual diagnosis, lithotripsy, and stone extraction, and avoid damage to human tissues caused by instantaneous high heat during lithotripsy, which is beneficial to improving the safety of lithotripsy surgery. The present non-invasive diagnosis and treatment system can be applied to the direction of non-invasive urinary lithotripsy to avoid damage to human tissues and cavities caused by heat and machinery; it can also be applied to the direction of non-invasive ERCP to avoid damage to organs and loss of functions caused by sphincter incision.

[0010] Further, a spare channel is also provided in the second channel.

[0011] Further, the basket assembly includes a basket section, a spring flexible tube section connected to the basket section, and a metal tube section (such as a stainless steel tube section or an alloy tube section) or a polymer material tube section connected to the spring flexible tube section; a memory basket is provided in the basket section, and a connecting portion is provided at one end of the memory basket, and the connecting portion connects the spring flexible tube section.

[0012] Further, the spring flexible tube section includes a flexible tube body, and metal wires arranged inside the tube wall of the flexible tube body. The metal wires are spirally wound or woven or linearly arranged along the length direction of the flexible tube body, and the tightness of the metal wires is gradually arranged in the direction from near the basket section to far from the basket section.

[0013] Further, a reserved end head of 1-4 mm is provided at the front end of the memory basket.

[0014] Further, the reserved end is connected and fixed with a hydrophilic head or a loach head with a length of 10-50 mm.

[0015] Further, super-slippery coatings are respectively provided on the inner and outer circumferences of the connecting portion and the spring flexible pipe section.

[0016] In some embodiments, the manufacturing method of the basket assembly includes the following steps:

[0017] Take a plurality of shape memory alloy wires, arrange the front sections of the plurality of shape memory alloy wires in a mesh structure on a basket mold, and wind or braid the middle and rear sections of the plurality of shape memory alloy wires parallelly on a mandrel behind the basket mold. After shaping, the memory basket and the connecting portion wound or braided with the shape memory alloy wires are obtained;

[0018] Perform high molecular material thermorheology on the connecting portion wound or braided with the shape memory alloy wires to obtain the tubular connecting portion. Leave 1-4 mm of the plurality of shape memory alloy wires at the front end of the basket mold as reserved ends, and connect a coaxial hydrophilic head or loach head in front of the reserved ends;

[0019] Take a metal wire, wind the metal wire into a spring wire with an axially spiral shape with different degrees of tightness, or braid or linearly arrange it into a network tube. It can also be partially spiral, partially braided, and the remaining part is linearly arranged into a network tube. Perform high molecular material thermorheology on the axially spiral spring wire or the network tube to form a flexible tube body, and obtain a spring flexible pipe section containing the spring wire or the network tube;

[0020] Connect the connecting portion with one end of the spring flexible pipe section, and connect the other end of the spring flexible pipe section with a metal pipe section or a high molecular material pipe section.

[0021] In some embodiments, the manufacturing method of the basket assembly includes the following steps:

[0022] Take a shape memory alloy tube, cut a plurality of tangents along the length direction on the shape memory alloy tube to obtain a plurality of wire meshes on the tube body of the shape memory alloy tube;

[0023] Remove a plurality of wire meshes, twist and form the remaining wire meshes by using a basket mold, and obtain a memory basket after cleaning, grinding and high-temperature shaping;

[0024] Leave 1-4 mm of the shape memory alloy tube at the front end of the memory basket as a reserved end, and perform high molecular material thermorheology on the rear section of the shape memory alloy tube to obtain a connecting portion; connect a coaxial hydrophilic head or loach head in front of the reserved end;

[0025] Take a metal wire, wind the metal wire into an axial helical spring wire with different degrees of tightness, or braid or linearly arrange it into a mesh tube, perform polymer material thermal rheology on the axial helical spring wire or the mesh tube to form a flexible tube body, and obtain a spring flexible tube section containing the spring wire or the mesh tube;

[0026] The connecting portion is connected to one end of the spring flexible tube segment, and the other end of the spring flexible tube segment is connected to a metal tube segment or a polymer material tube segment.

[0027] In some embodiments, the method for making the basket assembly comprises the following steps:

[0028] Take a memory alloy tube, cut it along the length direction from the end of the memory alloy tube, and obtain N network cables;

[0029] The front ends of some network cables are removed, and the front ends of the remaining network cables are twisted and formed using a mesh basket mold, and then cleaned, polished, and formed at high temperature to obtain a memory mesh basket;

[0030] A coaxial hydrophilic head or loach head is connected to the front end of the memory basket, and the rear section of the mesh wire and the remaining rear section of the memory alloy tube are heat-transformed to the connection part;

[0031] Take a metal wire, wind the metal wire into an axially spiral spring wire with different degrees of tightness, or braid or linearly arrange it into a mesh tube, perform polymer material thermal rheology on the axially spiral spring wire or the mesh tube to form a flexible tube body, and obtain a spring flexible tube section containing the spring wire or the mesh tube;

[0032] The connecting portion is connected to one end of the spring flexible tube segment, and the other end of the spring flexible tube segment is connected to a metal tube segment or a polymer material tube segment.

[0033] In some embodiments, the spiral spring wire is braided or linearly arranged into a mesh tube with a longer metal wire left behind. While the polymer material is thermally rheologically formed into a flexible tube body, the longer metal wire left behind can be rheologically formed into a metal tube segment.

[0034] Furthermore, the visual tube mirror comprises a tube mirror body, a tube mirror spring wire is spirally arranged in the tube wall of the tube mirror body along the length direction, and the inner periphery and outer periphery of the tube mirror body are respectively provided with a clear water coating.

[0035] Furthermore, the inner diameter of the tube body of the tube scope is 0.5-5 mm, the wall thickness of the tube body of the tube scope is 0.02-1 mm, and the cross-sectional area of the first cavity is more than 60% of the inner circumferential cross-sectional area of the tube body of the tube scope.

[0036] Furthermore, the camera assembly includes a camera module and a lighting module, and the camera module and the lighting module are both connected to cables, and the cables are led outward from the cable channel and connected to the display platform.

[0037] Furthermore, a camera assembly is provided at the front end of the visual tube mirror, and another camera assembly is provided near the direction adjustment portion of the visual tube mirror.

[0038] Furthermore, a direction-adjusting cavity is provided in the second cavity along the length direction, or a direction-adjusting cavity is provided in the inner wall of the visual tube mirror along the length direction; and a direction-adjusting component is provided in the direction-adjusting cavity.

[0039] Furthermore, the visual tube mirror is provided with a first-level steering section and a second-level steering section connected to the first-level steering section, and the umbrella-shaped component is provided at the front end of the first-level steering section; the first-level steering section and the second-level steering section are respectively provided with the steering component, and a plurality of the steering components are arranged on the same side or different sides.

[0040] Furthermore, the adjustment component includes an adjustment anchor point arranged in the adjustment cavity, and an adjustment guide wire connected to the adjustment anchor point, and the adjustment guide wire extends from the other end of the adjustment cavity and is connected to the adjustment handle.

[0041] Furthermore, the umbrella-shaped component includes a multi-petal umbrella leaf, one end of the multi-petal umbrella leaf is arranged at the end of the visual tube mirror, and the other end of the multi-petal umbrella leaf is close to the central axis of the visual tube mirror in a natural state. Under the action of the basket component, the multi-petal umbrella leaf expands outward.

[0042] Furthermore, a plurality of the umbrella pieces are distributed circumferentially, and deformation gaps are provided between adjacent umbrella pieces, and the width of the umbrella piece is gradually reduced from one end connected to the visual tube mirror to the other end; or the umbrella pieces of multiple petals are partially overlapped and folded in a petal-like arrangement.

[0043] Furthermore, the umbrella piece is a memory alloy piece, and a coating is provided on the outside of the umbrella piece, which can provide a rebound force, and is conducive to the umbrella piece closing to the initial state by itself.

[0044] In some embodiments, the non-destructive diagnosis and treatment system also includes a sheath, and the end of the sheath is also provided with the umbrella-shaped component; the ends of the sheath and the visual tube mirror are respectively provided with end rings, and the end rings are connected with umbrella-shaped bending wires; in a natural state, the umbrella-shaped bending wire is in a retracted state; when in use, the basket assembly is connected to the umbrella-shaped bending wire, and the umbrella-shaped bending wire follows the opening of the memory basket of the basket assembly.

[0045] Further, the manufacturing method of the umbrella-shaped component is as follows: Take a metal wire, bend the metal wire into a continuous wavy shape, weld the two ends of the wavy metal wire together to form an annular wavy ring, and sleevethe annular wavy ring on an umbrella-shaped mold and bind and shape it towards the middle to obtain a conical umbrella-shaped bent wire;

[0046] Weld the wave troughs of the umbrella-shaped bent wire to the end ring in sequence. After welding, coat the umbrella-shaped bent wire with a film to obtain the umbrella-shaped component, and connect the end ring to the end of the sheath tube or the visual endoscope.

[0047] Further, the manufacturing method of the umbrella-shaped component is as follows: Take a metal tube, cut out an umbrella-shaped bent wire with an annular wave at the end of the metal tube; Cut the metal tube with the umbrella-shaped bent wire to an appropriate length for later use;

[0048] Open a connection groove in the inner peripheral wall at the end of the sheath tube or the visual endoscope, insert the metal tube cut to an appropriate length into the connection groove, and after fixing, coat the umbrella-shaped bent wire and the metal tube with a film to form the umbrella-shaped component.

[0049] Further, the visual endoscope is manufactured by a segmented process, and at least includes a first segment and a second segment. The first segment includes a small-section endoscope tube body and the umbrella-shaped component, and the second segment is a long-section endoscope tube body. One end of the second segment is welded to the first segment, and the other end is connected to the operation handle.

[0050] Further, endoscope spring wires are provided inside the tube walls of the small-section endoscope tube body and the long-section endoscope tube body; The endoscope spring wires are formed into a tube body through helical winding or braiding on a mandrel and then undergoing high molecular material thermorheology.

[0051] Further, the non-invasive diagnosis and treatment system further includes an automatically bendable pyeloscope, which includes a visual pyeloscope tube body. The visual pyeloscope tube body has a front section that can bend by itself, and the first channel and the second channel are also provided inside the visual pyeloscope tube body.

[0052] Further, an expansion balloon is further provided on the hollow wire basket component. The expansion balloon is arranged near the connection part of the spring flexible tube section. The expansion balloon is used for expanding the channel, or dragging the stone outwards under the visual field after expansion, that is, the expansion balloon can be used for stone extraction.

[0053] For the hollow wire basket component, a wire basket anchor point is provided on the spring flexible tube section near the wire basket section, and the wire basket anchor point is connected with a wire basket steering guide wire; The steerable energy delivery catheter is a steerable electrode guide wire or an optical fiber guide wire. The steering cooperation between the two is beneficial to accurately hitting and extracting stones.

[0054] In some embodiments, a long core rod is provided for use with the hollow basket assembly. The long core rod can be inserted and pulled into the hollow channel. The front end of the long core rod passes through the memory basket and is used to support the front end of the memory basket so that the memory basket can be retracted. The rear end of the long core rod is provided with an end cap, and the end cap is detachably connected to the end of the metal pipe segment.

[0055] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The non-destructive diagnosis and treatment system can achieve non-destructive treatment of the human body through the arrangement of the energy platform (host), visual tube mirror, net basket and supporting tools, avoids the damage to the tissues in the human cavity caused by instruments during visual diagnosis, lithotripsy and stone removal, avoids the damage to the human tissues caused by the instantaneous high heat during lithotripsy, and is beneficial to improving the safety of lithotripsy; 2. The non-destructive diagnosis and treatment system can be used in the direction of non-destructive urinary lithotripsy to avoid the damage to human tissues and cavities caused by heat and machinery; it can also be used in the direction of non-destructive ERCP to avoid the damage and loss of function caused by the sphincter to the organs; it can also be used in hepatobiliary system stone surgery; 3. The energy platform (host), the visual tube mirror, the net basket assembly and supporting tools can be used in combination, or they can be used separately with existing equipment, which has strong versatility and wide applicability; 4. The spring wire is arranged in the flexible tube body, which can not only enhance its strength and flexibility, but also make it have better elasticity and adaptability, can adapt to different shapes by itself, and has good anti-fatigue performance. It is not easy to damage the flexible tube body during long-term bending, so that the service life of the flexible catheter is increased; 5. The spiral arrangement can enhance the strength and stability of the original tube body, and has deformation performance adapted to the position under different bending states and angles, and better support provides excellent tracking and controllability; 6. The setting of the adjustment component can not only realize the axial telescopic adjustment of the visual tube mirror, but also adjust it so that its front section can better reach the location of the stone; 7. The spare channel provided in the visual tube mirror can be passed through other types of catheters, and can also be used as an emergency channel; 8. Metal structures such as metal tube bodies and spring wires can extend outward and connect to the cooling platform, and the heat exchange between metal and cooling medium is used to achieve the purpose of cooling. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Figure 1 It is an overall schematic diagram of a non-destructive diagnosis and treatment system of the present invention;

[0057] Figure 2 A schematic diagram of a basket assembly in a non-destructive diagnosis and treatment system of the present invention;

[0058] Figure 3 It is a schematic diagram of cutting lines on the memory alloy tube during the manufacturing process of the basket assembly of the present invention;

[0059] Figure 4 Schematic diagram of the wire reserved during the manufacturing process of the basket assembly of the present invention;

[0060] Figure 5 Another manufacturing method of the basket assembly of the present invention, schematic diagram of the shape memory alloy tube cut open from the head;

[0061] Figure 6 Schematic diagram of the rear tangent of the shape memory alloy tube of the present invention not being removed and connecting the spring wire for thermorheology;

[0062] Figure 7 Schematic diagram of the visual endoscope in a non-invasive diagnostic and therapeutic system of the present invention;

[0063] Figure 8 Schematic diagram of the cross-sectional structure of the tube body of the visual endoscope of the present invention;

[0064] Figure 9 Schematic diagram of a structure of the umbrella-shaped assembly of the present invention;

[0065] Figure 10 Another schematic diagram of the structure of the umbrella-shaped assembly of the present invention;

[0066] Figure 11 Schematic diagram of the umbrella-shaped assembly of the present invention being retracted in the natural state;

[0067] Figure 12 Schematic diagram of the umbrella-shaped assembly of the present invention being opened under the action of the memory basket;

[0068] Figure 13 Schematic diagram of the setting of the primary guiding wire of the present invention;

[0069] Figure 14 Schematic diagram of the setting of the secondary guiding wire of the present invention;

[0070] Figure 15 Schematic diagram of the dilation balloon on the basket assembly of the present invention;

[0071] Figure 16 Schematic diagram of the automatic bending pyeloscope of the present invention;

[0072] Figure 17 Schematic diagram of the adjustable guiding basket assembly entering the renal pelvis and ureteral system;

[0073] Figure 18 Schematic diagram of the duodenum, duodenal papilla, hepatopancreatic ampulla and common bile duct;

[0074] Figure 19 Partial structural schematic diagram of the basket assembly in Example 2 of the present invention;

[0075] Figure 20 Schematic diagram of the collapsed state of the basket assembly in Embodiment 2 of the present invention;

[0076] Figure 21 Schematic diagram of the structure of the long core rod in Embodiment 2 of the present invention;

[0077] Figure 22 Schematic diagram of the basket assembly of the present invention in cooperation with different medical devices in Embodiment 2;

[0078] Figure 23 Cross-sectional schematic diagram of the basket assembly penetrating into the endoscope in Embodiment 2 of the present invention;

[0079] Figure 24 Cross-sectional schematic diagram of the basket assembly penetrating into the sheath in Embodiment 2 of the present invention;

[0080] Figure 25 Schematic diagram of the structure of the sheath and the umbrella assembly in Embodiment 3 of the present invention;

[0081] Figure 26 Top view schematic diagram of the end of the umbrella assembly in Embodiment 3 of the present invention;

[0082] Figure 27 Schematic diagram of the deployed structure of the umbrella-shaped bending wire in the umbrella assembly in Embodiment 3 of the present invention;

[0083] Figure 28 Another schematic diagram of the connection between the sheath and the umbrella assembly in Embodiment 3 of the present invention;

[0084] In the figure: 1, energy platform; 2, display platform; 3, steerable energy delivery catheter; 4, visual endoscope; 401, endoscope tube body; 5, basket assembly; 501, memory basket; 502, connection part; 503, spring flexible tube section; 504, metal tube section; 505, reserved end; 506, loach head; 507, spring wire; 508, wire mesh; 509, shape memory alloy wire; 6, umbrella assembly; 601, umbrella piece; 7, first channel; 8, second channel; 9, cable channel; 10, water channel; 11, spare channel; 12, endoscope spring wire; 13, water-clear coating; 14, steering anchor point; 15, steering guide wire; 16, visual curved pyeloscope; 17, dilation balloon; 18, outer tube; 19, hollow channel; 20, long core rod; 21, end cap; 22, sheath; 23, umbrella sheath tube body; 24, end ring; 25, umbrella-shaped bending wire; 26, connection groove. Detailed implementation manners

[0085] The technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.

[0086] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "middle", "upper", "lower", "left", "right", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0087] Embodiment 1

[0088] As Figures 1 - 8 shown, a non-invasive diagnosis and treatment system has a general platform, and the general platform at least includes an energy platform 1 and a display platform 2, an adjustable energy delivery catheter 3 connected to the energy platform 1, and a visual endoscope 4 connected to the display platform 2. At least an axially penetrating first channel 7 and a second channel 8 are provided in the visual endoscope 4. The cross-sectional dimension of the first channel 7 is larger than that of the second channel 8. At least a cable channel 9 and a water channel 10 are provided in the second channel 8. A camera assembly is provided in the cable channel 9. A movable and adjustable hollow basket assembly 5 is provided in the first channel 7. The adjustable energy delivery catheter 3 axially penetrates through the hollow channel of the basket assembly 5. An openable and closable umbrella-shaped assembly 6 is further provided at the end of the visual endoscope 4. When the basket assembly 5 passes through the umbrella-shaped assembly 6, the umbrella-shaped assembly 6 is passively opened, and when the basket assembly 5 retracts into the visual endoscope 4, the umbrella-shaped assembly 6 closes itself.

[0089] Through the settings of the energy platform 1, the display platform 2, the visual endoscope 4, the basket assembly 5 and supporting tools, etc., the present non-invasive diagnosis and treatment system can achieve non-invasive human body, avoid damage to the tissues in the human body cavity caused by instruments during visual diagnosis, lithotripsy and stone extraction, and avoid the damage to human tissues caused by the instantaneous high heat during lithotripsy, which is beneficial to improving the safety of lithotripsy surgery.

[0090] The present non-invasive diagnosis and treatment system can be applied to the direction of non-invasive urinary lithotripsy to avoid damage to human tissues and cavities caused by heat and machinery; it can also be applied to the direction of non-invasive ERCP to avoid damage and loss of function to organs caused by sphincters; it can also be applied in the surgery for liver and gallbladder system stones.

[0091] The energy platform 1 is an energy excitation platform, such as a liquid-electric platform, a laser emission platform, etc., which can provide lithotripsy energy for the steerable energy delivery catheter 3; the display platform 2 includes a controller and a display, and the display can be connected in multiple channels and can display different picture contents on split screens.

[0092] The energy platform 1 (main unit), the visible endoscope 4, the basket assembly 5, and supporting tools, etc. can be used together, or can be taken out separately and used in combination with existing equipment, with strong versatility and a wide range of applications.

[0093] The visible endoscope 4 is provided with two main channels. The cross-sectional area of the first channel 7 can be made relatively large, which can allow the basket assembly 5 to pass through it so that the basket assembly 5 can reach the lesion position. At the same time, the first channel 7 also serves as a stone extraction and aspiration channel to extract the broken stones. The second channel 8 is subdivided into multiple small channels. For example, the cable channel is used for wiring so that the cable of the camera assembly at the end can be led out from the channel. There are multiple water channels, which can inject liquid into the lesion, which can be the previous medicine solution or the cooling liquid (water) during the lithotripsy process. Let the water cool down the high heat generated by the lithotripsy, and use another water channel or the first channel to extract the high-temperature water vapor from the body to avoid high-temperature damage to tissues.

[0094] The visible endoscope 4 and the basket assembly 5 can also use metal wires (such as spring wires), metal tubes, metal sheets, etc. provided therein to exchange heat to achieve the purpose of rapid cooling. For example, an external cooling platform (low-temperature liquid nitrogen) is connected to these outward-extending metal structures, which can conduct the low temperature to the memory basket and the umbrella-shaped assembly to exchange heat and cool the high temperature generated by the lithotripsy, avoiding high-temperature damage to human tissues.

[0095] The basket assembly 5 can hold the stone at the stone location. For small stones that can be taken out, the basket assembly 5 can be directly used to take them out. For larger stones, lithotripsy operations can be performed and then taken out. Due to the presence of the basket assembly 5, the broken stones can be prevented from scattering, and the safety is higher.

[0096] The umbrella-shaped assembly 6 is opened when the basket assembly passes by, and is slightly inward in other states and will not expand outward, so as to avoid the umbrella-shaped assembly from causing harm to human tissues during the movement of the visible endoscope; during the lithotripsy process, the basket assembly 5 will cause the umbrella-shaped assembly 6 to expand outward, forming a circumferential protection circle between the basket and the human body cavity tissue, so that during the lithotripsy process, high temperature or broken stones can be further prevented from causing harm to the human body.

[0097] Furthermore, a spare channel 11 is also provided in the second channel 8. The spare channel 11 can be used to introduce other types of catheters or can be used as an emergency channel.

[0098] Furthermore, the basket assembly 5 includes a basket section, a spring flexible tube section 503 connected to the basket section, and a metal tube section 504 connected to the spring flexible tube section 503. The basket section is provided with a memory basket 501. One end of the memory basket 501 is provided with a connecting portion 502, and the connecting portion 502 is connected to the spring flexible tube section 503. The metal tube section 504 can be a stainless steel tube section and can be used to connect an operating handle to provide a certain strength at the operating end.

[0099] When the memory basket 501 extends out of the visual endoscope 4, it can return to its original structure in the memory state, that is, the memory basket 501 is opened to hold the calculus. The connecting portion 502 and the spring flexible tube section 503 are highly flexible and can be bent at multiple angles without damage, providing good flexibility and being able to adapt to the tortuous changes of the human body cavity.

[0100] The connecting portion 502, the spring flexible tube section 503, and the metal tube section 504 have a communicating inner cavity, which allows the adjustable energy delivery catheter to pass through, such as an electrode guide wire, so that the electrode guide wire can reach the memory basket accurately for targeted and accurate lithotripsy.

[0101] Furthermore, the spring flexible tube section 503 includes a flexible tube body and metal wires arranged inside the tube wall of the flexible tube body. The metal wires are spirally wound or braided along the length direction of the flexible tube body, and the tightness of the metal wires gradually changes from the direction close to the basket section to the direction away from the basket section.

[0102] By providing metal wires in the flexible tube body, it can not only enhance its strength and flexibility but also endow it with better elasticity and adaptability, enabling it to adapt to different shapes automatically, having good fatigue resistance, and being not easily damaged during long-term bending, thus increasing the service life of the flexible catheter. The spiral arrangement can enhance the strength and stability of the original tube body, have a deformation performance adapted to the position in different bending states and angles, good support performance, and excellent tracking and controllability.

[0103] Furthermore, a reserved end 505 with a length of 1 - 4 mm is provided at the front end of the memory basket 501.

[0104] Further, the reserved end 505 is connected and fixed with a hydrophilic head or a loach head 506 of 10 - 50 mm, so that the head directivity and passability of the basket assembly are better, and the integrity and non-injury are better.

[0105] Further, super-slippery coatings are respectively provided on the inner and outer circumferences of the connecting part 502 and the spring flexible pipe section 503, which is beneficial to the pushing and pulling movement of the basket assembly and also convenient for the insertion of the electrode guide wire.

[0106] For this non-invasive diagnosis and treatment system, the fabrication of the basket assembly with this special structure is very important. There is no suitable and feasible way to make such a multi-functional composite basket assembly in the prior art. The present invention provides the following various fabrication methods.

[0107] In some embodiments, the fabrication method of the basket assembly 5 includes the following steps:

[0108] Take 4 - 6 shape memory alloy wires. Arrange the front sections of the multiple shape memory alloy wires in a mesh structure on a basket mold, and wind or braid the middle and rear sections of the multiple shape memory alloy wires parallelly on a mandrel behind the basket mold. After shaping, the memory basket 501 and the connecting part 502 wound or braided with the shape memory alloy wires are obtained. The basket mold can be gourd-shaped, oval-shaped, diamond-shaped, etc. A mandrel is arranged behind the basket mold, so that the redundant shape memory alloy wires for making the memory basket body can be wound or braided on it to form a spiral structure for subsequent rheology.

[0109] Perform high molecular material thermal rheology on the connecting part wound or braided with the shape memory alloy wires to obtain the tubular connecting part 502. Leave 1 - 4 mm at the gathering place of the front ends of the multiple shape memory alloy wires on the basket mold as the reserved end 505, and connect a coaxial hydrophilic head or loach head 506 in front of the reserved end 505.

[0110] Take a metal wire, wind the metal wire into an axially helical spring wire with different degrees of tightness, and perform high molecular material thermal rheology on the axially helical spring wire 507 to form a flexible tube body, obtaining a spring flexible tube section 503 containing the spring wire.

[0111] Connect the connecting part 502 with one end of the spring flexible tube section 503, and connect the other end of the spring flexible tube section 503 with a metal tube section 504.

[0112] If the spring wire and the shape memory alloy wire are not connected by welding, a longer shape memory alloy wire can also be used to make the memory basket 501, and the redundant longer part at the rear is directly wound into an axially helical shape with different degrees of tightness, and high molecular material thermal rheology is performed on the axially helical spring wire to form a flexible tube body.

[0113] In some other embodiments, a manufacturing method of the basket assembly includes the following steps:

[0114] As Figure 3 shown, take a shape memory alloy tube of a suitable length, cut a plurality of tangents along the length direction on the shape memory alloy tube to obtain a plurality of wire meshes 508 on the tube body of the shape memory alloy tube;

[0115] Remove a plurality of wire meshes 508, and twist and form the remaining wire meshes by using a basket mold, and obtain a memory basket 501 after cleaning, grinding and high-temperature shaping;

[0116] That is, at a position near the end of a shape memory alloy tube, a plurality of slits are cut by laser to form tangents, for example, about 20 tangents are cut, and then 1 / 5 - 1 / 4 of them are removed, and the remaining 4 - 6 wire meshes are the original lines of the basket. Using a gourd-shaped basket mold, these wire meshes are formed, and the formed shape is memorized to obtain a deformable memory basket.

[0117] Through this process, 1 - 4 mm can be easily left at the front end of the shape memory alloy tube as a reserved end 505, and the rear section of the shape memory alloy tube undergoes high molecular material thermorheology to obtain a connecting part; a hydrophilic head or a loach head is coaxially connected in front of the reserved end 505. Due to the existence of the reserved end 505, the hydrophilic head or the loach head can be connected by using the existing holes. This method is better than other methods for setting the hydrophilic head or the loach head, and a reliable connecting part is provided at the end of the basket line.

[0118] Take a metal wire, wind the metal wire into a spring wire with an axially helical shape with different degrees of tightness, and perform high molecular material thermorheology on the axially helical spring wire to form a flexible tube body, and obtain a spring flexible tube section containing the spring wire. In this application, the high molecular material thermorheology can be carried out by using a high molecular material at 100 - 400 degrees Celsius. The high molecular material can be a high molecular material such as pebax72D, PEEK, TPU, etc.

[0119] Connect the connecting part with one end of the spring flexible tube section, and connect the other end of the spring flexible tube section with a metal tube section.

[0120] As Figure 4 shown, the metal wire is woven into a net tube, and extra metal wire is reserved behind the net tube, and high molecular material thermorheology is performed on it to form a flexible tube body. The extra metal wire at the rear can be used to connect the metal tube section.

[0121] In some other embodiments, the basket assembly can also be manufactured through the following steps:

[0122] Take a shape memory alloy tube, asFigure 5 As shown, cut along the length direction from the end of the shape memory alloy tube to obtain N pieces of wire meshes 508;

[0123] Remove the front ends of several wire meshes, twist and form the front ends of the remaining wire meshes using a wire basket mold, and obtain a memory wire basket after cleaning, grinding and heat setting; in this case, it is easier to sleave the remaining wire meshes on the gourd-shaped wire basket mold for forming.

[0124] Weld and connect a coaxial hydrophilic head or loach head at the front end of the memory wire basket, and perform high molecular material thermorheology on the rear section of the wire mesh and the remaining rear section of the shape memory alloy tube to obtain a connecting part;

[0125] Take a metal wire, wind the metal wire into a spring wire with axially helical coils of different tightness degrees, and perform high molecular material thermorheology on the axially helical spring wire to form a flexible tube body, thereby obtaining a spring flexible tube section containing the spring wire;

[0126] Connect the connecting part with one end of the spring flexible tube section, and connect the other end of the spring flexible tube section with a metal tube section.

[0127] As Figure 6 shown, for the tube body structure formed by directly connecting and performing thermorheology the rear tangent of the shape memory alloy tube with the spring wire made of metal wire without removing it, this way can make the connection between the connecting part and the spring flexible tube section more tight and integrated.

[0128] Further, as Figure 7 and Figure 8 shown, the visual endoscope 4 includes an endoscope tube body 401, and an endoscope spring wire 12 is spirally arranged along the length direction inside the tube wall of the endoscope tube body 401, and a clear water coating is respectively provided on the inner circumference and the outer circumference of the endoscope tube body 401.

[0129] Further, the inner diameter of the endoscope tube body 401 is 0.5 - 5 mm, the wall thickness of the endoscope tube body 401 is 0.02 - 1 mm, and the cross-sectional area of the first channel 7 is more than 60% of the inner circumferential cross-sectional area of the endoscope tube body, so that a larger access channel can be obtained, larger stones can pass through, and it is also more convenient for the wire basket assembly to pass through.

[0130] Further, the imaging assembly includes a camera module and a lighting module, both the camera module and the lighting module are connected with cables, and the cables are led out from the cable channel and connected to the display platform.

[0131] Further, an imaging assembly is provided at the front end of the visual endoscope 4, and another imaging assembly is provided at a distance of 10 - 50 mm from the steering part of the visual endoscope.

[0132] The camera assembly disposed at the front end of the visual endoscope 4 serves as the visualization perspective when the visual endoscope enters the human body cavity and can also better detect stones so that the memory basket can accurately catch the calculi.

[0133] Another camera assembly is disposed at a position at a certain distance from the front end of the visual endoscope 4. Since this visual endoscope has a steering function, the front section of the visual endoscope 4 can be bent upward or downward, which is convenient for the visual endoscope 4 to enter some positions in the human body that require turning, such as the renal pelvis. The visual endoscope first enters and forms a bent channel. When the basket assembly 5 passes through these bent channels, since it is invisible, the end of the basket assembly is likely to get stuck at the turning point and is not easy to detect, or it takes repeated blind operation attempts to make the memory basket reach the front end; when it is invisible at the turning point, it is impossible to predict when the basket assembly will reach that point, which will affect the normal progress and rhythm of the operation. Moreover, for existing endoscopes, during the blind insertion process, the end of the basket assembly may pierce the outer tube at the turning part of the endoscope, causing the basket to protrude from the turning point. If one continues to move the basket assembly without knowing this situation, it will cause great harm to the human body, even life-threatening, and such surgical risks exist in the actual process. By arranging another set of camera assemblies at a certain distance from the end, it is very convenient to observe the turning position in advance. When the basket assembly 5 reaches that point, it is easier to purposefully adjust the basket assembly 5 to make it pass through that point smoothly and reach the final calculus position. This structure with full visibility and adjustable direction can greatly improve the intubation success rate and accuracy and greatly shorten the operation time.

[0134] Further, a steering channel is provided along the length direction in the second channel 8, or a steering channel is provided along the length direction in the inner wall of the visual endoscope 4; a steering assembly is provided in the steering channel.

[0135] The setting of the steering assembly can not only realize the axial telescopic adjustment of the visual endoscope but also steer it so that its front section can better reach the position where the calculus is located.

[0136] Further, as Figure 13 and Figure 14 shown, the visual endoscope 4 is provided with a first-stage steering section and a second-stage steering section connected to the first-stage steering section. An umbrella-shaped assembly is provided at the front end of the first-stage steering section; the first-stage steering section and the second-stage steering section are respectively provided with the steering assembly, and multiple steering assemblies are arranged on the same side or different sides, such as being arranged at the 12 o'clock position and / or the 6 o'clock position.

[0137] Furthermore, the adjustment component includes an adjustment anchor point 14 arranged in the adjustment cavity, and an adjustment guide wire 15 connected to the adjustment anchor point 14. The adjustment guide wire 15 extends from the other end of the adjustment cavity and is connected to an adjustment handle, such as a pull ring with a limit position. By pulling the adjustment guide wire, a force is applied to the adjustment anchor point, thereby changing the direction of the visual tube endoscope.

[0138] The first adjustment anchor point is arranged 5-40mm away from the front end of the first-level adjustment section, and the second adjustment anchor point is arranged 1-5mm away from the end of the second-level adjustment section. This position is also where another camera assembly is arranged. The field of view is good. In addition to being able to see the adjustment position during adjustment, the stone held in the basket can also be seen, allowing the electrode guide wire inside the basket assembly to accurately break the stone. The camera assembly arranged at the front end of the visual tube scope is visible when it enters the human body cavity. When it reaches the stone position, the memory basket is extended, and the umbrella-shaped assembly is unfolded, its viewing angle will be affected, and it is not possible to fully see the stone held in the memory basket, so a camera assembly at another position is used for observation.

[0139] Further, such as Figure 9 As shown, the umbrella-shaped component 6 includes a multi-petal umbrella leaf 601, one end of the multi-petal umbrella leaf 601 is arranged at the end of the visual tube mirror 4, and the other end of the multi-petal umbrella leaf 601 is close to the central axis of the visual tube mirror 4 in a natural state, and the multi-petal umbrella leaf 601 is expanded outward under the action of the basket component.

[0140] Further, a plurality of the umbrella pieces 601 are distributed circumferentially, and deformation gaps are provided between adjacent umbrella pieces 601, and the width of the umbrella piece 601 is gradually reduced from one end connected to the visual tube mirror 4 to the other end; or Figure 10 As shown, the multi-petal umbrella blades 601 are arranged in a petal-like manner with parts overlapping and folding.

[0141] The umbrella-shaped component 6 can be made of a memory alloy sheet. In the memory state, it is in a closed or retracted state. Under the action of the memory basket 501, it can be appropriately expanded outward.

[0142] When implementing, Figure 11 and Figure 12As shown, the memory basket 501 extends from the umbrella-shaped component 6, causing the umbrella pieces 601 to open. When the memory basket 501 reaches the stone, it will automatically open and trap the stone. The stone is appropriately moved to be at the position of the open umbrella pieces, and the electrode wire extending from the basket component 5 is used to break the stone; during this process, the memory basket 501 holds the stone, enabling the electrode to break the stone more accurately, and also preventing the broken stones from scattering everywhere, ensuring that the stones do not jump, and enabling all stones to be cleaned up at once; the umbrella-shaped component forms a protective umbrella for the human body cavity, preventing the high-temperature steam from burning the human body cavity and also preventing the broken stones from scratching the human body cavity.

[0143] Further, a coating film is provided outside the umbrella piece 601.

[0144] Further, the visual endoscope 4 is manufactured by a segmented process, including a first segment and a second segment. The first segment includes a small-section endoscope tube body and the umbrella-shaped component, and the second segment is a long-section endoscope tube body. One end of the second segment is welded to the first segment and undergoes polymer thermorheology, and the other end is connected to the operating handle. By means of segmentation and polymer material thermorheology, it is relatively convenient to manufacture such a multi-channel tube body compounded with spring wires.

[0145] Specifically, endoscope spring wires 12 are provided inside the tube walls of both the small-section endoscope tube body and the long-section endoscope tube body; the endoscope spring wires 12 are formed into a tube body through spiral winding or braiding on a mandrel followed by polymer material thermorheology. The first channel 7 and the second channel 8 can be reserved during the tube body forming process by setting a small mandrel, and materials such as cables can be preset in the tube body or inserted later.

[0146] Further, the non-invasive diagnosis and treatment system further includes an automatically bendable pyeloscope 16, as Figure 16 and 17 shown. The automatically bendable pyeloscope 16 includes a visual pyeloscope tube body, and the visual pyeloscope tube body has a front section that can bend by itself. The first channel 7 and the second channel 8 are also provided inside the visual pyeloscope tube body. The structure and manufacturing method of the visual pyeloscope tube body 16 are basically similar to those of the visual endoscope 4, except that shape memory alloy wires are used to replace the endoscope spring wires, enabling the tube body to have a memory function, and making its front end be in a bent memory state during the forming process.

[0147] Due to the provision of a front section that can bend by itself, when in use, this automatically bendable pyeloscope 16 only needs to be straightened and inserted into the human body cavity. When it reaches the designated position and is released, its front section will bend by itself under the memory function, enabling its end to better enter the pyelogram position.

[0148] Further, the bending direction is marked at the front section that can be bent by itself. Correspondingly, a bending mark is also marked at the tail of the visible pyeloscope tube body 16. In this way, the bending direction of the front section can be visually judged towards which direction through the bending mark at the tail outside the human body. For the visible endoscope 4, these bending directions and bending marks can also be set at its front end to facilitate its orientation adjustment.

[0149] In some embodiments, as Figure 15 shown, an expansion balloon 17 is further provided on the basket assembly 5. The expansion balloon 17 is arranged near the connecting portion 502 of the spring flexible tube section 503. The expansion balloon 17 is used for expanding the channel, or dragging the stone outwards under the visible field of view after expansion, that is, the expansion balloon can be used for stone extraction. An outer tube is further provided outside the basket assembly 5, and this outer tube can be inserted into the first channel 7 and moved.

[0150] Further, a scale is also provided on the outer periphery of the hollow basket assembly near the memory basket 501 at the connecting portion. Through these scales, doctors can quickly judge the size of the broken stone. If it is less than 5 mm, the stone can be directly cleared. In the actual process, doctors control the instruments at the front end by using the images captured by the endoscope on the screen in the operating room. These images are magnified, which also causes the stones in the images to be magnified. Doctors cannot directly judge the size of the broken stone based on the images (the size of the stone before breaking is usually known during the preoperative examination). After setting this scale, according to the marks on the scale (which can be scale lines or reference lines), the basic size of the broken stone can be obtained very conveniently.

[0151] In the present invention, the basket has multiple levels and multiple functions. It is improved from the existing most basic basket to a coaxial hollow basket, and further to an orientation-adjustable function basket, a cooling basket, and a balloon basket. It can have one of these functions or multiple functions at the same time.

[0152] Taking a certain gallbladder stone as an example to illustrate the non-invasive diagnosis and treatment system, as Figure 18As shown, the duodenoscope can be used to find the duodenal papilla. After the visual tube scope is inserted, the visual tube scope 4 is adjusted according to the marked bending direction by using the adjustment guide wire 15, so that the tube portion of the visual tube scope 4 is directed toward the biopsy channel of the duodenal papilla. The visual tube scope 4 enters the biopsy channel to reach the bile and pancreatic ampulla in the adjusted state, and then enters the common bile duct to reach the gallbladder. The coaxial hollow basket assembly moves in the first cavity of the visual tube scope 4. Due to the arrangement of multiple camera assemblies, the coaxial hollow basket assembly can easily reach the designated position. The memory basket 501 at the end thereof extends from the umbrella assembly 6 at the end of the visual tube scope 4. The umbrella assembly 6 is opened, and before opening, it can be The camera assembly at the end of the visual tube mirror 4 is used to take pictures to obtain images in the human body cavity. After the umbrella-shaped assembly 6 is opened and the memory basket 501 is used to screen and crush the stone, the field of view of the camera assembly at the front end is not good. At this time, the camera assembly at the rear of the visual tube mirror 4 can be used to take pictures to obtain images in the state of crushing the stone; after the memory basket 501 holds the stone, the electrode wire extends from the axis of the hollow channel to crush the stone. After the stone is crushed, the small crushed stones will be sucked away and discharged. The scale at the front end of the basket assembly 5 can be used to judge the size of the larger crushed stones. If the stone is less than 5mm, the memory basket 501 can be used to drag the stone into the first cavity to remove the crushed stone. Through this system, a channel for crushing and removing stones can be quickly established, the operation time can be shortened, and the duodenal papilla can be avoided from being cut, so as to avoid damage to the organ and loss of function; at the same time, this method can also reduce the use of contrast.

[0153] Example 2

[0154] This embodiment provides a basket assembly with another structure and usage.

[0155] like Figures 19 - 21 As shown, a long core rod 20 is provided for use with the coaxial hollow basket assembly 5, and the long core rod 20 can be inserted and pulled into the hollow channel 19, and the front end of the long core rod 20 passes through the memory basket 501 to support the front end of the memory basket 501 so that the memory basket 501 can be retracted; the rear end of the long core rod 20 is provided with an end cap 21, and the end cap 21 is detachably connected to the end of the metal pipe section, and the end cap 21 can be a nut, and the end of the metal pipe section is provided with a thread connected thereto.

[0156] The hollow channel 19 can not only be used to insert electrode wires, biopsy forceps and other instruments, but can also be used in conjunction with the long core rod to allow the mesh to be retracted in the early stage so that it can enter various cavities. At this time, the basket assembly 5 does not need to be provided with an outer tube (basket sheath tube). The long core rod 20 is inserted along the hollow channel 19 of the basket tube body. When the end of the long core rod 20 abuts against the reserved end 505, a certain external force can be applied to make the memory basket 501 retract. In this state, the entire basket assembly 5 can smoothly enter the endoscopic, other sheath tubes and other medical devices (such as Figures 22 - 24 As shown), after reaching the designated position, the long core rod 20 is pulled out, the memory basket 501 opens automatically, and the hollow channel 19 is used to insert an electrode wire, an optical fiber or a biopsy forceps and other instruments to perform surgical operations such as removing objects and stones in the lesion area of the human body.

[0157] The advantage of not providing an outer tube is that the outer diameter of the entire basket assembly can be reduced, and the size of its internal hollow channel can be increased, so that it can enter various medical devices in small cavities, allow other instruments to pass through it, and also be able to remove larger stones.

[0158] Example 3

[0159] This embodiment provides another structure of sheath tube and umbrella piece.

[0160] like Figure 25 As shown, the sheath tube includes an umbrella sheath tube body 23, and the umbrella-shaped component is an end ring 24 arranged at the end of the umbrella sheath tube body 23, and the end ring 24 is connected with an umbrella-shaped bending wire 25; in a natural state, the umbrella-shaped bending wire 25 is in a retracted state; when in use, the basket assembly 5 is passed to the umbrella-shaped bending wire 25, and the umbrella-shaped bending wire 25 follows the expansion when the memory basket 501 of the basket assembly 5 is opened.

[0161] Furthermore, the materials of the umbrella-shaped bending wire 25 and the end ring 24 are both stainless steel wire or nickel-titanium alloy wire, and a polymer film is also provided on the periphery of the umbrella-shaped bending wire 25. The setting of the polymer film can provide restraint and resilience, and after the memory basket 501 of the basket assembly exits the umbrella-shaped area formed by the umbrella-shaped bending wire 25, the umbrella-shaped bending wire 25 closes to the initial state by itself under the resilience of the polymer film.

[0162] Furthermore, the manufacturing method of the umbrella-shaped component is: take a metal wire, bend the metal wire into a continuous wave shape, weld the two ends of the wave-shaped metal wire together to form an annular wave ring, set the annular wave ring on the umbrella-shaped mold and bind it to the middle to shape it, so as to obtain a tapered umbrella-shaped bent wire 25, such as Figure 26 and 27 As shown;

[0163] Successively weld the troughs of the umbrella-shaped bent wire 25 onto the end ring 24. After welding, coat the umbrella-shaped bent wire 25 to obtain the umbrella-shaped assembly, and connect the end ring 24 to the end of the sheath tube.

[0164] In the above manufacturing method, after the umbrella-shaped bent wire and the end ring are made, the two are welded into a whole and then connected and fixed to the umbrella sheath tube body; in this process, the end ring can be welded to the metal wire in the umbrella sheath tube body, or after coating, the polymer material can be fused with the polymer material on the umbrella sheath tube body.

[0165] In some other embodiments, the manufacturing method of the umbrella-shaped assembly is as follows: take a metal tube, and cut out an umbrella-shaped bent wire with a circular wave at the end of the metal tube; cut the metal tube with the umbrella-shaped bent wire to an appropriate length for use, as Figure 28 shown;

[0166] Open a connection groove 26 in the circumferential wall at the end of the umbrella sheath tube body 23, insert the metal tube cut to an appropriate length into the connection groove 26, and after fixing, coat the umbrella-shaped bent wire and the metal tube to form the umbrella-shaped assembly. By cutting, an umbrella-shaped bent wire with an end ring is formed, and this manufacturing method is simpler and more feasible, reducing the difficulty of welding.

[0167] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A non-invasive diagnosis and treatment system, characterized in that, It includes at least an energy platform and a display platform, an adjustable energy delivery catheter connected to the energy platform, and a visual endoscope connected to the display platform. At least an axially penetrating first channel and a second channel are provided inside the visual endoscope. The cross-sectional dimension of the first channel is larger than that of the second channel. At least a cable channel and a water channel are provided in the second channel. A camera assembly is provided in the cable channel. A movable and adjustable hollow basket assembly is provided in the first channel. The adjustable energy delivery catheter axially penetrates through the hollow channel of the basket assembly. An openable and closable umbrella-shaped assembly is further provided at the end of the visual endoscope. When the basket assembly passes through the umbrella-shaped assembly, the umbrella-shaped assembly is passively opened. When the basket assembly retracts into the visual endoscope, the umbrella-shaped assembly closes itself.

2. The non-invasive diagnostic and treatment system according to claim 1, characterized in that A spare channel is further provided in the second channel.

3. The non-invasive diagnostic and treatment system according to claim 1, characterized in that The basket assembly includes a basket section, a spring flexible tube section connected to the basket section, and a metal tube section or a polymer material tube section connected to the spring flexible tube section. A memory basket is provided in the basket section. One end of the memory basket is provided with a connecting portion, and the connecting portion connects the spring flexible tube section. The spring flexible tube section includes a flexible tube body and metal wires arranged inside the tube wall of the flexible tube body. The metal wires are spirally wound, braided or linearly arranged along the length direction of the flexible tube body. The tightness of the metal wires is gradually arranged from the direction close to the basket section to the direction far from the basket section.

4. The non-invasive diagnosis and treatment system according to claim 3, characterized in that, A reserved end head of 1-4 mm is provided at the front end of the memory basket. A hydrophilic head or a loach head with a length of 10-50 mm is connected and fixed to the reserved end head.

5. The non-invasive diagnosis and treatment system according to claim 3, characterized in that, Polymer material layers are respectively provided on the inner and outer circumferences of the connecting portion, the spring flexible tube section and the metal tube section, and a super-slippery coating is provided on the polymer material layer.

6. The non-invasive diagnostic and therapeutic system according to claim 1 or 3, characterized in that, The manufacturing method of the basket assembly includes the following steps: Take a plurality of shape memory alloy wires, arrange the front sections of the plurality of shape memory alloy wires in a mesh structure on a basket mold, and wind or braid the middle and rear sections of the plurality of shape memory alloy wires in parallel on a mandrel behind the basket mold. After shaping, the memory basket and the connecting portion wound or braided by the shape memory alloy wires are obtained. Perform polymer material thermorheology on the connecting portion wound or braided by the shape memory alloy wires to obtain the tubular connecting portion. Leave 1-4 mm of the plurality of shape memory alloy wires at the front end of the basket mold as a reserved end head, and connect a coaxial hydrophilic head or loach head in front of the reserved end head. Take metal wires, wind the metal wires into axially spiral spring wires with different tightness degrees, or braid or linearly arrange them into a net tube. Perform polymer material thermorheology on the axially spiral spring wires or the net tube to form a flexible tube body, and obtain a spring flexible tube section containing the spring wires or the net tube. Connect the connecting portion to one end of the spring flexible tube section, and connect the other end of the spring flexible tube section to a metal tube section or a polymer material tube section.

7. The non-invasive diagnostic and treatment system according to claim 1 or 3, characterized in that, The manufacturing method of the basket assembly includes the following steps: Take a shape memory alloy tube, cut a plurality of tangents along the length direction on the shape memory alloy tube to obtain a plurality of wire meshes on the tube body of the shape memory alloy tube. Remove several wire meshes, twist and form the remaining wire meshes using a wire basket mold, clean, polish and heat-set them to obtain a memory wire basket; Leave 1-4 mm at the front end of the shape memory alloy tube as a reserved end, and perform thermo-rheology on the rear section of the shape memory alloy tube to obtain a connecting part; connect a coaxial hydrophilic head or loach head in front of the reserved end; Take a metal wire, wind the metal wire into an axially helical spring wire with different degrees of tightness, or braid or linearly arrange it into a net tube, and perform thermo-rheology on the axially helical spring wire or the net tube with a polymer material to form a flexible tube body, obtaining a spring flexible tube section containing a spring wire or a net tube; Connect the connecting part with one end of the spring flexible tube section, and connect the other end of the spring flexible tube section with a metal tube section or a polymer material tube section.

8. The non-invasive diagnosis and treatment system according to claim 1 or 3, characterized in that The manufacturing method of the wire basket assembly includes the following steps: Take a shape memory alloy tube, cut it along the length direction from the end of the shape memory alloy tube to obtain N wire meshes; Remove the front ends of several wire meshes, twist and form the front ends of the remaining wire meshes using a wire basket mold, clean, polish and heat-set them to obtain a memory wire basket; Connect a coaxial hydrophilic head or loach head at the front end of the memory wire basket, and perform thermo-rheology on the rear section of the wire mesh and the remaining rear section of the shape memory alloy tube to obtain a connecting part; Take a metal wire, wind the metal wire into an axially helical spring wire with different degrees of tightness, or braid or linearly arrange it into a net tube, and perform thermo-rheology on the axially helical spring wire or the net tube with a polymer material to form a flexible tube body, obtaining a spring flexible tube section containing a spring wire or a net tube; Connect the connecting part with one end of the spring flexible tube section, and connect the other end of the spring flexible tube section with a metal tube section or a polymer material tube section.

9. The non-invasive diagnostic and treatment system according to claim 1, wherein The visible endoscope includes an endoscope tube body, and endoscope spring wires are spirally arranged along the length direction inside the tube wall of the endoscope tube body, and a clear water coating is respectively provided on the inner circumference and the outer circumference of the endoscope tube body.

10. The non-invasive diagnostic and treatment system according to claim 9, characterized in that, The inner diameter of the endoscope tube body is 0.5-5 mm, the wall thickness of the endoscope tube body is 0.02-1 mm, and the cross-sectional area of the first channel is more than 60% of the inner circumferential cross-sectional area of the endoscope tube body.

11. The non-invasive diagnosis and treatment system according to claim 1, wherein, The camera assembly includes a camera module and a lighting module, both the camera module and the lighting module are connected with cables, and the cables are led out from the cable channel and connected to the display platform.

12. The non-invasive diagnostic and therapeutic system according to claim 1, wherein One camera assembly is provided at the front end of the visible endoscope, and another camera assembly is provided near the steering part of the visible endoscope.

13. The non-invasive diagnostic and treatment system according to claim 1, wherein, A steering channel is provided along the length direction in the second channel, or a steering channel is provided along the length direction in the inner wall of the visible endoscope; a steering assembly is provided in the steering channel.

14. The non-invasive diagnosis and treatment system according to claim 13, wherein, The visible endoscope is provided with a first-level steering section and a second-level steering section connected to the first-level steering section, and an umbrella-shaped assembly is arranged at the front end of the first-level steering section; the first-level steering section and the second-level steering section are respectively provided with the steering assembly, and a plurality of the steering assemblies are arranged on the same side or on different sides.

15. The non-invasive diagnosis and treatment system according to claim 13, characterized in that The steering component includes a steering anchor point disposed within the steering channel, and a steering guide wire connected to the steering anchor point. The steering guide wire extends from the other end of the steering channel and is connected to a steering handle.

16. The non-invasive diagnostic and treatment system according to claim 1, wherein The umbrella-shaped component includes multiple umbrella pieces. One end of the multiple umbrella pieces is disposed at the end of the visual endoscope. In the natural state, the other ends of the multiple umbrella pieces approach the central axis of the visual endoscope, and under the action of the basket component, the multiple umbrella pieces expand outward.

17. The non-invasive diagnosis and treatment system according to claim 16, wherein A number of the umbrella pieces are circumferentially distributed, and a deformation gap is provided between adjacent umbrella pieces. The width of the umbrella piece is gradually reduced from the end connected to the visual endoscope to the other end; or the multiple umbrella pieces are arranged in a petal shape with partial overlap and folding.

18. The non-invasive diagnostic and treatment system according to claim 16, wherein, The umbrella piece is made of a shape memory alloy material, and a film is provided outside the umbrella piece.

19. The non-invasive diagnostic and treatment system according to claim 1, wherein It further includes a sheath tube, and the end of the sheath tube is also provided with the umbrella-shaped component; end rings are respectively provided at the ends of the sheath tube and the visual endoscope, and an umbrella-shaped bending wire is connected to the end rings. In the natural state, the umbrella-shaped bending wire is in a folded state; during use, the basket component reaches the umbrella-shaped bending wire, and the umbrella-shaped bending wire unfolds following the opening of the memory basket of the basket component.

20. The non-invasive diagnostic and treatment system according to claim 19, wherein The manufacturing method of the umbrella-shaped component is as follows: Take a metal wire, bend the metal wire into a continuous wavy shape, weld the two ends of the wavy metal wire together to form a circular wavy ring, and sleeved the circular wavy ring on an umbrella-shaped mold and constrict it towards the middle to obtain a conical umbrella-shaped bending wire. Weld the troughs of the umbrella-shaped bending wire to the end rings in sequence. After welding, cover a film on the umbrella-shaped bending wire to obtain the umbrella-shaped component, and connect the end rings to the end of the sheath tube or the visual endoscope.

21. The non-invasive diagnostic and treatment system according to claim 19, wherein The manufacturing method of the umbrella-shaped component is as follows: Take a metal tube, and cut out an umbrella-shaped bending wire with a circular wave at the end of the metal tube. Cut the metal tube with the umbrella-shaped bending wire to an appropriate length for standby. Open a connection groove in the peripheral wall of the end of the sheath tube or the visual endoscope, insert the metal tube cut to an appropriate length into the connection groove, and after fixing, cover a film on the umbrella-shaped bending wire and the metal tube to form the umbrella-shaped component.

22. The non-invasive diagnosis and treatment system according to claim 1, wherein The visual endoscope is manufactured by a segmented process, and at least includes a first segment and a second segment. The first segment includes a small-section endoscope tube body and the umbrella-shaped component. The second segment is a long-section endoscope tube body. One end of the second segment is welded to the first segment, and the other end is connected to an operation handle.

23. The non-invasive diagnostic and treatment system according to claim 22, wherein Tube mirror spring wires are provided inside the tube walls of the small-section endoscope tube body and the long-section endoscope tube body; the tube mirror spring wires are formed into tube bodies through spiral winding or braiding on a mandrel followed by high molecular material thermorheology.

24. The non-invasive diagnostic and therapeutic system according to claim 1, wherein It further includes an automatically bendable pyeloscope, and the automatically bendable pyeloscope includes a visual pyeloscope tube body. The visual pyeloscope tube body has a front section that can bend by itself, and the first channel and the second channel are also provided inside the visual pyeloscope tube body.

25. The non-invasive diagnosis and treatment system according to claim 3, wherein The basket assembly is also provided with an expansion balloon, which is arranged on the spring flexible tube section near the connecting portion. The expansion balloon is used to expand the channel, or to drag the stone out in a visible field of view after expansion.

26. The non-invasive diagnostic and treatment system according to claim 3, wherein The spring flexible tube section is provided with a basket anchor point near the basket section, and the basket anchor point is connected to a basket adjustment guide wire; the adjustable energy delivery catheter is an adjustable electrode guide wire or an optical fiber guide wire.

27. The non-invasive diagnosis and treatment system according to claim 3, characterized in that, It also includes a long core rod used in conjunction with the hollow basket assembly, the long core rod can be inserted and pulled into the hollow channel, the front end of the long core rod passes through the memory basket and is used to support the front end of the memory basket to make the memory basket collapse; the rear end of the long core rod is provided with an end cap, and the end cap is detachably connected to the end of the metal pipe section.

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