Flexible surgical instruments, catheters, and joint components

Abstract

The present invention provides a flexible surgical instrument, a catheter and a joint assembly, wherein the joint assembly includes a joint portion and a node, wherein two adjacent joint portions include two nodes located on different radial sides thereof, and the adjacent joint portions are configured to rotate relative to each other around the node therebetween, and the node includes a male connector and a female connector respectively provided on the two adjacent joint portions; the male connector is at least partially rotatably inserted into the first concave surface of the female connector through a first convex arc surface; the first convex arc surface and the first concave arc surface face each other, and the two first concave arc surfaces are inclined relative to the rotation centerline of the male connector, and are both inclined toward the outside of the joint portion or are both inclined toward the inside of the joint portion. The joint portion of the present invention achieves relative rotation and anti-drop connection between the joint portions through the cooperation of the male and female connectors at the node, without the need to provide special joint hinge components, thereby reducing the number of components and improving the structural compactness of the product.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to a flexible surgical instrument, a catheter and a joint assembly. Background Art

[0002] With the advancement of minimally invasive surgical techniques and artificial intelligence (AI), robotic-assisted minimally invasive surgery is becoming a growing trend in minimally invasive surgery. Minimally invasive surgery can be performed through natural orifices on the patient's body or through one or more surgical incisions. Through these natural orifices or incisions, doctors can insert minimally invasive medical devices, such as surgical instruments, diagnostic instruments, therapeutic instruments, or biopsy instruments, into the patient's target location.

[0003] In order to accurately guide the corresponding minimally invasive medical device to the target location, minimally invasive surgery can be equipped with an endoscope for the minimally invasive medical device. The endoscope allows the doctor to provide a visual field showing tissues, organs and / or instruments during the insertion, removal or performance of the medical procedure. For example, during an examination using a bronchoscope, the slender flexible tool containing the endoscope can be inserted into the patient's mouth, passed through the patient's throat, and then into the trachea, pulmonary airways, and lungs, allowing the doctor to examine the internal conditions of the patient's pulmonary airways, such as the bronchi and bronchioles, so that the doctor can perform a diagnosis and / or a medical procedure.

[0004] Surgical tools such as endoscopes are usually configured at the distal ends of different slender flexible tools. The slender flexible tools are driven from outside the patient's body and deform as needed inside the body, such as in a narrow cavity. The structural design of the slender flexible tools needs to ensure the compactness of the product structure to reduce its space occupation. Summary of the Invention

[0005] In view of the deficiencies of the prior art, the present invention provides a flexible surgical instrument, catheter and joint assembly, which can ensure the structural compactness of the product so that it can be driven as needed to flexibly deform within the patient's body.

[0006] In order to achieve the above-mentioned purpose, the present invention adopts the following technical solutions:

[0007] A joint assembly for a flexible surgical instrument, comprising:

[0008] Joints;

[0009] Nodes, wherein two adjacent joint portions comprise two nodes located on different radial sides thereof, and the adjacent joint portions are configured to rotate relative to each other about the node therebetween, and the node comprises a male connector and a female connector respectively provided on the two adjacent joint portions;

[0010] The male connector is at least partially rotatably inserted into the first concave surface of the female connector through the first convex surface; the first convex surface and the first concave surface face each other, and the two first concave surfaces are inclined relative to the rotation center line of the male connector, and are both inclined toward the outside of the joint part or both inclined toward the inside of the joint part.

[0011] In one embodiment, the free end of the male connector includes the first C-shaped convex arc surface, and the female connector includes the first concave arc surface and a notch communicating with the first concave arc surface;

[0012] The first convex arc surface is embedded in the first concave arc surface and is loosely fitted therewith. The notch is configured to at least partially accommodate the non-free end of the male connector and limit the angular range of rotation of the first convex arc surface within the first concave arc surface.

[0013] In one embodiment, the female connector includes a first C-shaped arm, wherein the first C-shaped arm has a second convex arc surface on the outer edge;

[0014] The node further includes a second concave arc surface extending from both sides of the non-free end of the male connector and concentric with the first convex arc surface, and the second convex arc surface is clearance-fitted with the second concave arc surface.

[0015] As one embodiment, the second convex arc surface and the second concave arc surface are inclined surfaces facing each other.

[0016] In one embodiment, the free end of the male connector includes a second C-shaped arm, and the second C-shaped arm has a third convex arc surface on the outer edge;

[0017] The node further includes a third concave arc surface extending from both sides of the non-free end of the female connector and concentric with the first concave arc surface, and the third convex arc surface is clearance-fitted with the third concave arc surface.

[0018] As one embodiment, the angular range of rotation of the first convex arc surface at the distal end of the joint component within the first concave arc surface is greater than the angular range of rotation of the first convex arc surface at the proximal end of the joint component within the first concave arc surface.

[0019] As one embodiment, each section of the joint portion includes two limiting portions, and the limiting portions of two adjacent sections of the joint portion are staggered in the circumferential direction of the joint component.

[0020] Another object of the present invention is to provide a catheter, comprising a drive wire, a flexible second tube body and a joint assembly as mentioned above, wherein the joint assembly is connected to the distal end of the second tube body, one end of the drive wire is arranged at the distal end of the joint assembly, and the other end passes through the corresponding threading channel on the joint assembly in sequence along the length direction and is then led out to the proximal end of the second tube body.

[0021] As one embodiment, the catheter also includes a connecting ring connecting the joint assembly and the second tube body, the distal outer wall of the connecting ring is protruding with multiple thickened parts, and the proximal end of the joint assembly is provided with an installation slot configured for inserting the thickened part.

[0022] As one embodiment, the catheter also includes an elastic tube that is sleeved on the outside of the drive wire and can be compressed in the axial direction. The inner surface of the thickened portion is provided with an axially extending receiving groove, and the elastic tube and / or the drive wire are at least partially received in the receiving groove.

[0023] Another object of the present invention is to provide a flexible surgical instrument comprising an outer sheath and the above-mentioned catheter, wherein the catheter is configured to be detachably inserted into and removed from the outer sheath.

[0024] The joint parts of the present invention achieve relative rotation and anti-drop connection between the joint parts through the cooperation of male and female connectors at the nodes, without the need to set up special joint hinge parts, reducing the number of parts and improving the structural compactness of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0026] Figure 1 This is a schematic structural diagram of a flexible surgical instrument according to an embodiment of the present invention;

[0027] Figure 2 is a simplified structural schematic diagram of a catheter in a non-bent state according to an embodiment of the present invention;

[0028] Figure 3 This is a simplified structural diagram of a flexible surgical instrument in a bent state according to an embodiment of the present invention;

[0029] Figure 4 This is a schematic structural diagram of a tip portion according to an embodiment of the present invention;

[0030] Figure 5AThis is a schematic diagram of a partial structural decomposition of a catheter according to an embodiment of the present invention;

[0031] Figure 5B This is a schematic diagram of a partial structure of a catheter according to an embodiment of the present invention;

[0032] Figure 6 A schematic diagram of the internal structure of an outer sheath according to an embodiment of the present invention is shown;

[0033] Figure 7A This is a schematic diagram of a catheter alignment method according to an embodiment of the present invention;

[0034] Figure 7B A schematic diagram showing another alignment method of a catheter according to an embodiment of the present invention is shown;

[0035] Figure 7C A schematic diagram showing another alignment method of a catheter according to an embodiment of the present invention is shown;

[0036] Figure 8A A schematic diagram showing the interior structure of a catheter according to an embodiment of the present invention is shown;

[0037] Figure 8B A schematic diagram showing a matching method between a connecting ring and a first tube body according to an embodiment of the present invention is shown;

[0038] Figure 8C A schematic diagram showing a matching method between a connecting ring and a second tube body according to an embodiment of the present invention is shown;

[0039] Figure 9 A schematic diagram showing the distal end structure of a catheter with an internal device according to an embodiment of the present invention is shown;

[0040] Figure 10 Shown Figure 9 Schematic diagram of the structural decomposition;

[0041] Figure 11 A schematic diagram showing the distal end structure of another catheter with an internal device according to an embodiment of the present invention is shown;

[0042] Figure 12 A schematic diagram showing the distal end structure of another catheter with an internal device according to an embodiment of the present invention is shown;

[0043] Figure 13 A schematic diagram of the distal end structure of another catheter with an internal device according to an embodiment of the present invention is shown;

[0044] Figure 14 This is a structural diagram of an image acquisition component according to an embodiment of the present invention;

[0045] Figure 15 A schematic perspective view of the structure of a tip portion according to an embodiment of the present invention;

[0046] Figure 16 A schematic structural diagram of a first tube body according to an embodiment of the present invention is shown;

[0047] Figure 17 for Figure 16 Enlarged view of point A in the middle;

[0048] Figure 18A Shown Figure 16 Schematic diagram of the installation method of the threading buckle;

[0049] Figure 18B A schematic diagram of a method for threading a drive wire in a first tube is shown;

[0050] Figures 19A to 19H Schematic diagrams showing several different installation methods of threading buckles according to embodiments of the present invention;

[0051] Figure 20 A schematic structural diagram of a second first tube body according to an embodiment of the present invention is shown;

[0052] Figure 21A Shown Figure 20 A front view of the first tube body shown;

[0053] Figure 21B for Figure 21A Enlarged view of point B in the middle;

[0054] Figure 21C for Figure 21B A schematic cross-sectional view of

[0055] Figure 22 A schematic structural diagram of a second first tube body according to an embodiment of the present invention is shown;

[0056] Figure 23A Shown Figure 22 A front view of the second tube body shown;

[0057] Figure 23B for Figure 23A Enlarged view of point C in the middle;

[0058] Figure 23C for Figure 23B A schematic cross-sectional view of

[0059] Figure 24 A schematic structural diagram of a third first tube body according to an embodiment of the present invention is shown;

[0060] Component Symbol Description:

[0061] 10-catheter; 10H-working channel; 11-catheter body; 11V-second alignment part; 110-driving wire; 110a-elastic tube; 111-first tube body; 112-second tube body; 1110-driving wire limiter; 12-channel tube; 13-image acquisition assembly; 13a-image module; 13b-light source; 14-tip end; 14V-first alignment part; 141-second through hole; 142-first through hole; 143-connecting ring; 144-flanged edge; 145-recess; 15-positioning sensor; 20-outer sheath; 21-insertion channel; 30-internal instrument; 321-fluid channel; L-signal line; 51-joint body; 510-joint part; 511-node; 511 a-connecting beam; 513-first through hole; 514-limiting part; 515-interlayer; 516-main body; 517-notch; 518-anti-slip part; 5111-male connector; 5111a-first convex arc surface; 5111b-second concave arc surface; 5111c-third convex arc surface; 5112-female connector; 5112a-first concave arc surface; 5112b-second convex arc surface; 5112c-notch; 5112d-third concave arc surface; 52-threading buckle; 520-threading channel; 521-blocking part; 522-spring; 522a-wing; 522b-threading part; 5210-limiting foot; C1-first C-shaped arm; C2-second C-shaped arm; M-interlayer space; S-slope. DETAILED DESCRIPTION

[0062] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0063] It should be noted that when an element is referred to as being "disposed on" another element, it may be directly on the other element or there may also be an element centered thereon. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may also be an element centered thereon. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods. The terms "distal end" and "proximal end" used herein are directional terms, which are commonly used terms in the field of interventional medical devices, where "distal end" refers to the end away from the operator during surgery, and "proximal end" refers to the end close to the operator during surgery.

[0064] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0065] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature identified as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0066] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used herein in the specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0067] The following is a detailed description with reference to the accompanying drawings.

[0068] See Figure 1 An embodiment of the present invention provides a flexible surgical instrument, which mainly includes a catheter 10 and an outer sheath 20. An insertion channel 21 is provided inside the outer sheath 20. The insertion channel 21 has a diameter slightly larger than that of the catheter 10. The outer sheath 20 can be inserted into the patient's body along a predetermined lumen path. The catheter 10 is configured to detachably insert and remove the outer sheath 20 along the insertion channel 21, thereby entering a predetermined position in the body or withdrawing from a predetermined position.

[0069] Exemplarily, the catheter 10 and the outer sheath 20 are both slender tubular structures, and the main body is made of flexible material. In order to accurately control the movement of the slender tube in the human body lumen (for example, a tube or body cavity such as an airway, trachea, or gastric tube), the catheter 10 and the outer sheath 20 can use a drive wire arranged along its length to control the degree of freedom of its distal end, thereby changing the shape, stiffness, and orientation of the distal end of the slender tube. Such a drive mode enables the operator to control the movement of the distal end of the slender tube at the proximal end of the slender tube located outside the body. For example, two drive wires arranged oppositely in one radial direction of the slender tube can provide a degree of freedom in a certain direction (such as pitch), four drive wires arranged oppositely in two different radial directions of the slender tube can provide more degrees of freedom in more directions (such as pitch, yaw, and steering), and the cooperation of the drive wires on the catheter 10 and the outer sheath 20 can provide more degrees of freedom for the catheter 10. It is understandable that the number of drive wires is not limited to this and can be adjusted as needed.

[0070] Figure 2 A simplified schematic diagram of the structure of the catheter in a non-bent state is shown. Figure 3 A simplified structural diagram of a flexible surgical instrument in a bent state is shown. Figures 1 to 3 This embodiment provides a flexible surgical instrument catheter 10, which includes a catheter body 11, a channel tube 12, an image acquisition component 13 and a tip 14. The catheter body 11 is the main part of the catheter 10, combined with Figure 4 As shown in FIG5 , the channel tube 12 is disposed in the catheter body 11, and the image acquisition assembly 13 includes an image device and its signal line L. The signal line L is disposed in the gap between the channel tube 12 and the catheter body 11, and the image device is housed and fixed in the tip portion 14. In one embodiment, the tip portion 14 is connected to the distal end of the catheter body 11 and has a first through hole 142 and a second through hole 141. The image device is housed in the second through hole 141. A connecting ring 143 is protruded from the proximal end of the tip portion 14. The connecting ring 143 is protruded along the edge of the first through hole 142 toward the channel tube 12. The channel tube 12 is sleeved on the outer surface of the connecting ring 143 and communicates with the first through hole 142 to form a working channel (such as Figure 3(shown by the dotted line). For example, the connecting ring 143 can have an inner wall that is coplanar with the first through hole 142, thereby forming a smooth instrument working channel. Since the imaging device is integrated into the distal end 14, the signal line L is routed in the gap between the channel tube 12 and the catheter body 11, so that the catheter 10 has both an instrument working channel and the function of an endoscope. It can cooperate with the outer sheath 20 to guide the movement of the outer sheath 20 within the human body, and can also provide a working channel and a movement carrier for internal instruments to enter and exit. When the internal instrument extends out of the working channel, it can also provide a movement field of view for the internal instrument. In this way, multiple functions are achieved using a small, slender tube structure, the compactness of the structure is improved, and the space requirements for the surgical process are reduced. Compared with the method of simply bonding the end face or outer wall of the channel tube 12 to the first through hole 142, the channel tube 12 is sleeved on the outer surface of the connecting ring 143 and connected to the first through hole 142, which can have a stronger connection performance. During the bending process of the catheter 10, the channel tube 12 is not easy to be separated from the distal end 14, thereby preventing blood, mucus and other fluids from entering the body from the separation point, and can also achieve a better waterproof effect.

[0071] like Figure 4 As shown in Figures 5 and 6, the image device of this embodiment includes an image module 13a and two light sources 13b. The two light sources 13b are located on either side of the image module 13a to provide fill light for the environment surrounding the image module 13a. The image module 13a and the light sources 13b are simultaneously embedded within the tip portion 14 and located within different second through-holes 141. For example, the second through-hole 141 includes a module hole 141a and light source holes 141b located on either side of the module hole 141a. The image module 13a and the two light sources 13b are inserted into the corresponding through-holes from the proximal end of the tip portion 14 and secured by an interference fit and / or adhesively bonded to the tip portion 14. The diameter of the first through-hole 142 is larger than that of the second through-hole 141. The second through-holes 141 are spaced apart around the first through-hole 142 to optimize product space utilization. By completely embedding the image module 13a and the two light sources 13b within the tip portion 14, the image device can be protected to a certain extent.

[0072] In other embodiments, the number of light sources 13b may be increased or decreased as appropriate, and their positions are not limited thereto. For example, each light source 13b may be located on the same side of the image module 13a. Alternatively, only the distal end of the image module 13a or at least one of the two light sources 13b may be embedded within the distal end portion 14, with the proximal end located within the gap between the catheter body 11 and the channel tube 12.

[0073] For example, Figure 4 、 Figure 6 and Figure 7AIn addition to the connecting ring 143, the distal end portion 14 also includes a flange 144 that simultaneously surrounds the connecting ring 143, the second through hole 141, and the first through hole 142. The connecting ring 143, the flange 144, and the proximal surface of the distal end portion 14 form an annular space, and the distal end of the catheter body 11 is mounted between the connecting ring 143 and the flange 144. The flange 144 can be a single ring or multiple rings spaced apart in the circumferential direction. For example, the outer circumferential surface of the distal end of the catheter body 11 can have an interference fit with the inner wall of the flange 144, and the two can be reinforced by bonding with an adhesive. For another example, the outer circumferential surface of the catheter body 11 near the distal end can have a slightly smaller diameter, forming a step portion. The catheter body 11 is inserted into the flange 144, and the step portion abuts against the end surface of the flange 144, thereby limiting further insertion of the catheter body 11. In one embodiment, the distal end surface of the catheter body 11 does not contact the proximal surface of the tip portion 14 between the connecting ring 143 and the flange 144, but rather maintains a certain gap. The distal end of the channel tube 12 can have an interference fit with the connecting ring 143. For example, the distal end of the channel tube 12 can be expanded and then sheathed over the outer circumference of the connecting ring 143. The two can also be bonded and reinforced with an adhesive.

[0074] Exemplarily, the catheter 10 also includes a positioning sensor 15 for locating the position of the distal end of the catheter 10. The positioning sensor 15 is at least partially fixed on the distal end 14. For example, the positioning sensor 15 may include an EM (Electro Magnetic) sensor. A detection magnetic field is arranged in the patient's environment. The detection magnetic field can be generated by a magnetic field generator arranged on one side of the patient. Flexible surgical instruments and medical devices are components of medical devices. When the position and angle of the EM sensor are different, the current generated in the coil of the EM sensor is different, so as to locate the position and orientation of the distal end of the catheter 10. In other embodiments, the positioning sensor can also be replaced by other sensing modules, such as light sensors, ultrasonic probes, gyroscopes, etc. In actual applications, the orientation of the distal end of the catheter 10 can be obtained with the help of an EM sensor to calibrate the field of view of the image acquisition component 13. For example Figure 4 and Figure 6 In the embodiment, the distal end portion 14 includes two recesses 145 extending through at least its proximal surface, and the distal end of the positioning sensor 15 is inserted into the recess 145. Since the positioning sensor 15 is integrated into the catheter 10, when the outer sheath 20 needs to be inserted into the body, the catheter 10 and the outer sheath 20 can be inserted simultaneously, with the positioning sensor 15 providing motion navigation for the outer sheath 20, and the imaging device on the catheter 10 also providing a field of view for it.

[0075] Here, recess 145 is a groove that does not extend through the distal end of tip 14. Position sensor 15 is protected within it by tip 14 to prevent liquid from coming into contact with it. The wires of position sensor 15, similar to signal wires L of an imaging device, extend from the gap between channel tube 12 and catheter body 11 to the proximal end to transmit the position signal detected by position sensor 15. In some embodiments, recess 145 may also be a through-hole extending through the distal end of tip 14, allowing position sensor 15 to be visible from the distal end of tip 14.

[0076] The figure illustrates a catheter 10 comprising two EM sensors. These two EM sensors are arranged axially in a cross-direction, forming a predetermined angle with each other. The distal ends of the two EM sensors extend away from each other. Each EM sensor can detect the motion of its respective location, and the combination of the two EM sensors can detect deflection of the distal end of the catheter 10. The two positioning sensors 15 can be located on opposite sides of the image module 13a, with each recess 145 located between the module aperture 141a and a light source aperture 141b. It will be appreciated that in other embodiments, there can be one or more positioning sensors 15, and the relative position of the positioning sensors 15 and the light source 13b can be adjusted.

[0077] like Figure 5A Exemplarily, the distal surface of the tip portion 14 includes a slope S inclined toward the outer peripheral surface. The slope S can prevent the distal end of the tip portion 14 from scratching the tissue, and can also guide the catheter 10 to be inserted into the outer sheath 20 or the body. The figure shows a situation in which a single-sided slope S is formed after a portion of material is cut off on one side of the tip portion 14. The slope S intersects with the first through hole 142. The image device and the two EM sensors are located on the same side of the distal end of the tip portion 14 that does not have the slope S (as shown above in FIG5 ). The wires of the two EM sensors and the signal line L are located on the same side of the channel tube 12 (as shown above in FIG5 ). It can be understood that in other embodiments, the slope S can be omitted, or there can be more than one, but it is necessary to reserve an installation area for the image module 13a.

[0078] like Figure 6The outer sheath 20 includes a tubular body 22 and an outer sheath drive wire 23. The insertion channel 21 runs through the axial direction of the tubular body 22. A hollow channel 220 is provided on the wall of the tubular body 22. The outer sheath drive wire 23 is passed through the hollow channel 220, and its distal end is fixed to the distal end of the tubular body 22, and the proximal end is led out from the hollow channel 220 to the connecting wire drive mechanism. Specifically, a fixing ring 24 can be installed at the distal end of the tubular body 22. For example, the fixing ring 24 is fixed in the wall of the tubular body 22 by an embedded manner. The distal end of the outer sheath drive wire 23 is fixed on the fixing ring 24, and the fixing ring 24 is used to disperse the stress of the outer sheath drive wire 23 on the wall of the tubular body 22. Along the length direction of the tubular body 22, the tubular body 22 can include an active bending section at the distal end and a passive bending section at the proximal end. The active bending section has lower rigidity than the passive bending section to ensure that when the outer sheath drive wire 23 acts, the passive bending section will not or basically will not bend.

[0079] The tubular body 22 can be a multi-layer composite structure, with the outer sheath drive wire 23 passing through the hollow channel 220 of the intermediate layer between the inner layer and the outer layer. The inner wall of the hollow channel 220 can be a PTFE (Poly tetrafluoroethylene) material with a lubricating effect to meet the lubrication requirements of the drive wire movement. Four outer sheath drive wires 23 can be provided in the tubular body 22 to drive the pitch and yaw of the outer sheath, and the four hollow channels 220 are arranged in the tubular body 22 at intervals in the circumferential direction. It is understandable that in other embodiments, the number of outer sheath drive wires 23 can also be changed, and the tubular body 22 can also be a single-layer structure.

[0080] like Figure 5A 、 5B 7A, the tip portion 14 may further include a first alignment portion 14V, and correspondingly, the catheter body 11 includes a second alignment portion 11V. When the tip portion 14 is assembled to the distal end of the catheter body 11, the second alignment portion 11V needs to be aligned and engaged with the first alignment portion 14V to ensure that the installation orientation of the imaging device is correct, and after installation, the imaging device will not be rotated or misaligned relative to the catheter body 11.

[0081] Figures 7A to 7C Schematic diagrams of three different catheter alignment methods are shown. Figure 7A In the figure, the first alignment portion 14V is a notch groove opened on the flange 144, and the second alignment portion 11V is a first protrusion radially protruding from the distal end of the catheter body 11. When the distal end 14 is assembled to the distal end of the catheter body 11, the first protrusion is stuck in the notch groove. Figure 7B In the figure, the first alignment portion 14V is a strip-shaped protrusion provided on the inner wall of the flange 144, and the second alignment portion 11V is a groove opened on the distal end surface of the catheter body 11. When the tip portion 14 is assembled to the distal end of the catheter body 11, the strip-shaped protrusion is stuck in the groove. Figure 7CIn the embodiment, the first alignment portion 14V is a slot defined on the proximal surface of the distal end portion 14 between the connecting ring 143 and the flange 144. The second alignment portion 11V is a second protrusion extending axially from the distal end of the catheter body 11. When the distal end portion 14 is assembled to the distal end of the catheter body 11, the second protrusion is inserted into the slot. It is understood that the first and second protrusions described above may be configured as bumps, columns, or the like, and the first and second alignment portions 14V, 11V may include one or more of the aforementioned configurations. The number of first and second alignment portions 14V, 11V may be more than one, for example, multiple first and second alignment portions 14V, 11V may be spaced apart circumferentially.

[0082] like Figure 1 、 Figure 2 and Figure 8A The catheter body 11 of this embodiment includes a flexible first tube 111 and a drive wire 110 configured to drive the first tube 111 to change its curvature. The first tube 111 includes a drive wire stopper 1110 located near the distal end of the first tube 111 and spaced apart from the distal end surface of the first tube 111. The drive wire 110 extends along the length of the catheter body 11 and its distal end is restrained on the side of the drive wire stopper 1110 facing the distal end portion 14. For example, the distal end of the drive wire 110 is prevented from proximally escaping the drive wire stopper 1110 by a stopper or an enlarged end. The drive wire stopper 1110 is not located on the distal end surface of the catheter body 11 but is located at a distance from the distal end surface. This prevents interference between the distal end of the drive wire 110 and structures proximal to the distal end portion 14, thereby protecting structures such as the positioning sensor and the image acquisition assembly 13 to a certain extent.

[0083] The catheter body 11 can be made of a single layer of material or a multi-layer composite material. Divided along the length direction of the catheter body 11, the catheter body 11 can be divided into a first tube body 111 at the distal end and a second tube body 112 at the proximal end. The first tube body 111 has a larger curvature than the second tube body 112. The inner surface of the catheter body 11 can be provided with a threading portion 1100. The distal end of the drive wire 110 is limited by the drive wire limiting portion 1110. Its proximal end passes through the corresponding threading portion 1100 and is led out from the proximal end of the catheter body 11 to the tensioning mechanism, thereby changing the configuration of the catheter body 11 under the action of the tensioning mechanism. The first tube body 111 acts as an active bending portion, changing its curvature under the drive of the drive wire 110, and the second tube body 112 acts as a passive bending portion, deforming under the drive of the first tube body 111. In other embodiments, the threading portion 1100 can be located on the outer surface of the catheter body 11 or pass through the catheter wall.

[0084] For example, the outer surface of the driving wire 110 is further provided with an elastic tube 110a (eg, Figure 1), the elastic tube 110a is always in an elastically compressed state. When the tension acting on the drive wire 110 is removed, the elastic tube 110a recovers its deformation, so that the catheter body 11 returns to its original shape, thereby improving the flexibility of the catheter 10. The elastic tube 110a can be, for example, a spring tube, a plastic tube, etc. Furthermore, the elastic tube 110a does not have to run through the entire length direction of the catheter body 11. For example, it is only provided in the second tube body 112, so that the two ends of the elastic tube 110a are respectively fixed relative to the two ends of the second tube body 112. This method can allow more design space in the first tube body 111 of the same diameter, and the first tube body 111 can be made thinner. Figure 1 In the figure, the catheter body 11 includes a connecting ring 113 connecting the first tube body 111 and the second tube body 112. The distal end of the elastic tube 110a is fixed to the connecting ring 113 by welding, fastener fixation, or abutment. The first tube body 111 and the second tube body 112 are respectively sleeved on the two ends of the connecting ring 113.

[0085] like Figure 8B 、 8C , shows a method for installing an elastic tube 110a within a catheter body 11. The distal outer wall of the connecting ring 113 is protruded with four thickened portions 1131. These thickened portions 1131 are thicker than the wall thickness of the rest of the catheter body 11, forming bumps. The four thickened portions 1131 are spaced apart on the outer circumference of the connecting ring 113. The proximal end of the first tube 111 is provided with mounting slots 111C that match the positions and number of the thickened portions 1131. These slots 111C are constructed as notches that penetrate the end and wall of the first tube 111. The two ends of the connecting ring 113 are respectively inserted into the first and second tubes 111, 112. The thickened portions 1131 of the connecting ring 113 are inserted into the corresponding mounting slots 111C on the first tube 111. The distal end of the elastic tube 110a is fixed to the inner wall of the thickened portions 1131.

[0086] like Figure 8C Each thickened portion 1131 also has an axially extending receiving groove 1132 on its inner surface. Specifically, the receiving groove 1132 is recessed from the inner wall of the connecting ring 113 into the thickened portion 1131. When the connecting ring 113 is installed in the first tube 111, the receiving groove 1132 can be closer to the outer wall of the first tube 111 than to the inner wall of the first tube 111. The elastic tube 110a and the drive wire 110 can be at least partially received in the receiving groove 1132. This allows the installation of the elastic tube 110a and the drive wire 110 to occupy less space within the first tube 111, allowing the drive wire 110 to be closer to the first tube 111. This makes the catheter body 11 more compact and allows more design space for other components, such as the guide wire and the channel tube 12. It is understood that the number of thickened portions 1131 can also be adjusted based on the number of drive wires 110.

[0087] like Figure 9 As shown, the flexible surgical instrument further includes an internal instrument 30, which is detachably inserted into and removed from the working channel 10H where the channel tube 12 is located. The internal instrument 30 includes, but is not limited to, various surgical instruments, such as cautery instruments, clamping instruments, cutting instruments, suturing instruments, electric hooks, and irrigation instruments. Figure 9 The internal instrument 30 shown is an irrigation instrument. A fluid channel 321 for fluid to pass through is opened axially in the internal instrument 30. By inserting the internal instrument 30 along the working channel 10H of the catheter 10, the target site can be irrigated.

[0088] For example, the positioning sensor can be made on the distal end surface of the internal instrument 30, and the positioning sensor can be used to provide navigation for the internal instrument 30, for example, to provide real-time navigation during the flushing process. Figure 10 Internal instrument 30 includes an elongated tubular body 32 and a first positioning sensor 33. Internal instrument 30 is configured to be removably inserted into working channel 10H. Elongated tubular body 32 is provided with a fluid channel 321 extending along its length. First positioning sensor 33 is secured to the distal end of elongated tubular body 32 and positioned adjacent to fluid channel 321. Fluids such as flushing fluids can be injected and withdrawn through fluid channel 321. First positioning sensor 33 can be similar to positioning sensor 15, including but not limited to an EM sensor, a light sensor, an ultrasound probe, or a gyroscope. The contours of working channel 10H and elongated tubular body 32 match, providing a clearance fit between the two.

[0089] Exemplarily, the internal instrument 30 has at least two first positioning sensors 33, and the two first positioning sensors 33 generate different output signals in response to the magnetic field emitted by the magnetic field generator. The position of the first positioning sensor 33 can be known according to the output signal of any one of the first positioning sensors 33. By comparing the output signals of the two first positioning sensors 33, the relative positions of the two first positioning sensors 33 can be determined, thereby determining the orientation of the internal instrument 30, realizing the detection of the position and orientation of the internal instrument 30, and providing a basis for adjusting the direction of the internal instrument 30.

[0090] Illustratively, the elongated tubular body 32 is provided with a mounting channel 322 extending along its length and an arc-shaped partition 323 extending along its length and arching toward the mounting channel 322. The first positioning sensor 33 is secured within the mounting channel 322, which is separated from the fluid channel 321 by the partition 323. The signal line of the first positioning sensor 33 can be led out of the mounting channel 322 to the proximal end. Because the first positioning sensor 33 is relatively small, the cross-sectional area of ​​the fluid channel 321 is often larger than that of the mounting channel 322 to ensure sufficient fluid flow. The partition 323 is an arc-shaped thin-walled partition, which isolates the fluid channel 321 and the installation channel 322 from each other. On the one hand, it can prevent the fluid from entering the channel where the first positioning sensor 33 is located and causing a short circuit. On the other hand, the arched arc-shaped partition 323 surrounds the installation channel 322, that is, the fluid channel 321 surrounds the installation channel 322 of the first positioning sensor 33 therein, so that the fluid channel 321 is at least partially arranged around the first positioning sensor 33, thereby making the cross-sectional area of ​​the fluid channel 321 as large as possible.

[0091] Optionally, at least a portion of the inner wall of the fluid channel 321, such as at least one inner wall of the fluid channel 321 that is not adjacent to the first positioning sensor 33 (such as Figure 10 As shown, the upper wall of the fluid channel 321 is designed to be a thin wall that matches the contour of the internal instrument 30. For example, it is made into an arc that matches the outer wall of the slender tube body 32. The arc-shaped wall of the fluid channel 321 is thinner, and the cross-section of the fluid channel 321 surrounded by the arc-shaped wall is larger, thereby ensuring the flow rate of the channel.

[0092] In other embodiments, the fluid channel 321 may not be arranged around the first positioning sensor 33 , but may be arranged only adjacent to the first positioning sensor 33 , and the partition 323 may also be flat or arched away from the installation channel 322 .

[0093] For example, the internal instrument 30 may have an anti-rotation feature. Here, the anti-rotation feature includes a non-circular profile of the internal instrument 30, that is, the cross-section of the working channel 10H is non-circular, so that when the elongated tubular body 32 is loosely fitted with the working channel 10H, the elongated tubular body 32 cannot rotate within the working channel 10H. In other words, the cross-section of the internal instrument 30 has different dimensions in at least two different directions, and the cross-section of the first through-hole 142 has different dimensions in at least two different directions. For example, the cross-sectional profile of the internal instrument 30 may be one of an elliptical, crescent-shaped, "D"-shaped, sector-shaped (i.e., "V"-shaped), or square-shaped, or a combination of at least two of these, with the cross-sectional shape of the working channel 10H matching the cross-sectional shape of the first through-hole 142. For example, the anti-rotation feature may also include having two opposing sides with different shapes, such as an arcuate upper surface and a square lower surface. Figure 10The cross-sectional profile of the internal instrument 30 and the working channel 10H is shown as being "D"-shaped. The image module 13a and two light sources 13b are located above and on the left and right sides of the working channel 10H, respectively. The surface of the working channel 10H near the image module 13a and the two light sources 13b is flat. The image module 13a is near the first positioning sensor 33, and the other surfaces are generally curved. Figure 11 The working channel 10H is shown in a round shape, with the upper and lower surfaces of the working channel 10H being curved and the left and right surfaces being flat. The first positioning sensor 33 is located below and away from the image module 13a. Figure 12 The working channel 10H is shown to be elliptical in shape, and the working channel 10H is arranged laterally below the image module 13a and the two light sources 13b.

[0094] In other embodiments, the anti-rotation feature may also include a raised portion (or recessed portion) provided on the outer circumference of the internal instrument 30, and correspondingly, a recessed portion (or raised portion) provided on the inner wall of the working channel 10H. When the internal instrument 30 is inserted into the working channel 10H, the cooperation between the raised portion and the recessed portion restricts the rotation of the internal instrument 30. For example, Figure 13 The raised portion 324 on the outer circumference of the internal instrument 30 extends along the length of the internal instrument 30, forming a raised strip. The first positioning sensor 33 and the mounting channel 322 are at least partially located (i.e., completely or partially located in the radial direction) within this raised strip. A corresponding recessed portion 10h is provided on the inner wall of the working channel 10H, extending along its length. The raised portion 324 mates with the recessed portion 10h and can be used to guide the insertion of the internal instrument 30 and to restrict relative rotation between the two. The first positioning sensor 33 can also be partially or completely protruded from the working channel 10H, thereby increasing the space within the working channel 10H to a certain extent. In other embodiments, the first positioning sensor 33 may not be located within this raised strip, or the raised portion 324 on the outer circumference of the internal instrument 30 may not extend along the length of the internal instrument 30, but may simply be one or more segments of raised blocks, or one or more raised points.

[0095] This anti-rotation feature prevents the first positioning sensor 33 from rotating or being installed upside down, enabling precise navigation. It is understood that the first positioning sensor 33 can be formed only on the internal instrument 30, or positioning sensors can be provided on both the catheter 10 and the internal instrument 30. The positioning sensors on the two structures can respectively detect the position of the catheter 10 and the internal instrument 30, respectively. Together, they can determine the relative position of the two positioning sensors, enabling navigation of the catheter 10 and the internal instrument 30 of the flexible surgical instrument in different positions. In some embodiments, the flexible surgical instrument may not include the outer sheath 20.

[0096] like Figure 14 and Figure 15 , shows the structure and installation method of an image acquisition component, the image acquisition component includes a flexible circuit board 13c, the image module 13a and the light source 13b are both arranged on the flexible circuit board 13c, and the signal line L is connected to the flexible circuit board 13c, thereby realizing the integrated design of the image acquisition component. For example, the flexible circuit board 13c can have a base 13d and two branches 13e, and the contacts at the end of each branch are respectively attached to a light source 13b. The image module 13a is attached to another contact on the base 13d located between the two branches 13e. The proximal end of the tip 14 is also provided with a recessed portion 141c for embedding the base 13d. The recessed portion 141c is simultaneously connected to the module hole 141a and the light source hole 141b for accommodating the image module 13a and the light source 13b. The base 13d can be embedded in the recessed portion 141c, and the signal line L is connected to the corresponding terminal on the base 13d. The base 13d can also serve as a base fixed in the recessed portion 141c.

[0097] like Figure 16 and Figure 17 , shows a first tube body 111. The first tube body 111, as a flexible joint component, mainly includes a joint body 51 and multiple threading buckles 52. The joint body 51 includes multiple annular joint sections 510, nodes 511 connecting two adjacent joint sections 510, and multiple limiting portions arranged at intervals along the length direction of the joint body 51. Each threading buckle 52 is provided with a threading channel 520 for the drive wire 110 to pass through. Each threading buckle 52 is detachably fixed to a different limiting portion. One end of the drive wire 110 is provided at the distal end of the joint body 51, and the other end passes through the corresponding threading channel 520 on the first tube body 111 in sequence along the length direction and is then led to the proximal end of the second tube body 112. The adjacent joint sections 510 are configured to produce relative deflection about the node 511 between them under the tension of the drive wire 110.

[0098] In some embodiments, the joint portion 510 may not be annular, for example, it may be a solid column, and the threading channel 520 may be provided outside the joint portion 510. In some embodiments, only part of the threading buckle 52 may be detachably fixed to the limiting portion, while the other part of the threading buckle 52 may be non-detachably connected to or integrally provided with the limiting portion.

[0099] Combine Figure 18AAs shown, the limiting portion is a first through hole 513 passing through the wall of the joint portion 510, and the threading buckle 52 includes a head portion provided with a threading channel 520 and a tail portion provided with a blocking portion 521. The size of the threading buckle 52 is configured to allow the head portion where the threading channel 520 is located to pass through the first through hole 513, and to limit the blocking portion 521 from passing through the first through hole 513. That is, the size of the head portion of the threading buckle 52 is smaller than the size of the tail portion, so that the blocking portion 521 can prevent the tail portion of the threading buckle 52 from passing through the first through hole 513 with the head portion, thereby clamping the threading buckle 52 on the inner wall of the first through hole 513.

[0100] Exemplarily, the threading buckle 52 is wedge-shaped, and the threading channel 520 is opened at the smaller head of the wedge-shaped threading buckle 52 . Figure 18A The figure shows the situation where the driving wire 110 is arranged in the first tube body 111. The first through hole 513 is a trumpet hole that is small inside and large outside. The threading buckle 52 passes through the first through hole 513 from the outside to the inside, so that the threading channel 520 at its head is located in the first tube body 111, and the blocking part 521 is embedded in the first through hole 513 and clamped to the hole wall.

[0101] It is understandable that the shape of the head of the threading buckle 52 includes but is not limited to a triangle, a rectangle, a trapezoid, and an arc.

[0102] After the threading buckle 52 is installed, the drive wire 110 can be passed through the threading channel 520, so as to string together the threading buckles 52 corresponding to the length direction of the first tube body 111. For example, four circumferentially spaced limiting portions can be provided on each joint portion 510. Alternatively, each joint portion 510 can have only two limiting portions, and the limiting portions of two adjacent joint portions 510 are staggered in the circumferential direction of the joint body 51; or, four circumferentially spaced limiting portions are provided on one joint portion 510, and no limiting portion is provided on the upper and / or lower joint portion 510 (such as Figure 16), by alternately providing limiting portions on the joint portion 510 in the axial direction of the joint body 51, the number of openings in the material can be reduced, the strength of the joint can be improved, and the arrangement of the drive wires 110 can be maintained. For example, two limiting portions are provided on one radial side of a joint portion 510, and two limiting portions on the joint portion 510 above and / or below the joint portion 510 are provided on the other radial side of the corresponding joint portion 510. For another example, two limiting portions are symmetrically provided at both radial ends of the joint portion 510, and the line connecting the two limiting portions on the joint portion 510 above and / or below the joint portion 510 intersects the line connecting the two limiting portions on the joint portion 510, so that only two drive wires 110 are positioned on each joint portion 510, and the four drive wires 110 are respectively provided in four sets of threading channels 520 spaced apart in the circumferential direction, and each set of threading channels 520 is parallel to the axial direction of the first tube 111. In some embodiments, each set of threading channels 520 may not be parallel to the axial direction of the first tube 111, but may be in a spiral S-shape, that is, every two adjacent driving wires 110 are not parallel, but staggered at a certain spiral angle, and even at least one driving wire 110 may be set to rotate in the opposite direction to the other driving wires to avoid twisting and distortion of the catheter during the driving process. For example, two spirally extending driving wires 110 are arranged on different sides in the radial direction, and the two driving wires on the same side in the radial direction have opposite rotation directions (such as Figure 18B ). In order to make the proximal end of the joint body 51 (or the second tubular body 112, or the outer sheath 20) have greater bending stiffness, the portion of the drive wire near the proximal end of the joint body 51 (or the second tubular body 112) can be set to be non-parallel to the axial direction of the tubular body in which it is located, and the other parts of the drive wire remain parallel to the axial direction of the tubular body in which it is located, and at least two adjacent drive wires are staggered at a certain spiral angle or rotated in opposite directions and cross-arranged, so that the proximal end of the tubular body is less likely to deform and avoid unexpected bending; further, the spiral pitch near the distal end of the drive wire can also be set to be smaller than the proximal end. When the threading channel 520 of the same drive wire 110 is arranged in a spiral S shape, the accommodating groove 1132 on the inside of the thickened portion 1131 can also be spirally shaped to match the arrangement of the threading channel 520. In other embodiments, it is also possible to have only one limiting portion in at least one joint portion 510, or not to set any limiting portion on multiple consecutive joint portions 510. In order to accommodate the movement of the S-shaped drive wire 110 , the threading channel 520 may also be configured as a corresponding arc-shaped channel.

[0103] Illustratively, along the length of the first tube 111, adjacent nodes 511 at two levels are staggered in the circumferential direction of the joint body 51. For example, the two nodes 511 at the proximal end of each intermediate joint body 51 are symmetrically arranged along a first radial direction, while the two nodes 511 at the distal end of the joint body 51 are symmetrically arranged along a second radial direction perpendicular to the first radial direction. In other embodiments, the staggered angle between the first and second radial directions can be other than 90°, or can be non-staggered. Figure 16 In the figure, viewed from the end face of the joint body 51, the four drive wires 110 and the four nodes 511 are evenly spaced in the circumferential direction, dividing the circumference of the joint body 51 into 8 equal parts. The four drive wires 110 are arranged in pairs, respectively driving the two adjacent joint sections 510 to deflect relative to each other, and the nodes 511 thereof bend and deform under tension. It is understandable that in other embodiments, the drive wires 110 may not be staggered with the nodes 511, that is, the limiting portion is arranged on the same side of the node 511, for example, Figure 17 The first through hole 513 is opened on the side of the joint portion 510 where the connecting beam 511 a is located, and is located on the extension line of the connecting beam 511 a.

[0104] In addition, the first tube body 111 can also include a flexible wrapping layer located on the outer peripheral surface of the joint body 51. The flexible wrapping layer can be a flexible sleeve that is sleeved on the outer peripheral surface of the joint body 51 after the threading buckle 52 is installed, or it can be a plastic material integrally formed on the outer peripheral surface of the joint body 51.

[0105] Figures 19A to 19H Shows several different Figure 18A How to install the threading buckle.

[0106] like Figure 19A The blocking portion 521 includes two limiting legs 5210 at the rear end of the threading buckle 52. The two limiting legs 5210 are splayed away from each other and are restricted from entering the first through-hole 513 by the edge of the first through-hole 513. The distance between the free ends of the two limiting legs 5210 is greater than the circumferential dimension of the first through-hole 513 at the joint portion 510. As a result, after the threading buckle 52 passes through the first through-hole 513, the two limiting legs 5210 abut against the edge of the first through-hole 513 and prevent it from entering. The threading passage 520 at the head of the threading buckle 52 forms a closed ring.

[0107] like Figure 19B , the structure of threading buckle 52 is Figure 19A The main difference is that the threading channel 520 at the head of the threading buckle 52 of this embodiment is not closed, but is a V-shaped space surrounded by two arms of the threading buckle 52 respectively connected to the two limit feet 5210. When the threading buckle 52 is installed, the driving wire 110 is passed through the V-shaped space and is located between the threading buckle 52 and the wall of the joint body 51.

[0108] like Figure 19C , the structure of threading buckle 52 is Figure 19B are roughly the same, the main difference is Figure 19B The threading buckle 52 shown in the figure is installed from the outside of the joint part 510 with its head facing inward. After installation, the head of the threading buckle 52 is inside the joint part 510 and the tail is outside the joint part 510. The blocking part 521 at the tail prevents the threading buckle 52 from falling out of the first through hole 513. The installation direction of the threading buckle 52 in this embodiment is the same as that of the threading buckle 52 in the embodiment. Figure 19B In contrast, threading buckle 52 is installed into joint portion 510 with its head facing outward. After installation, the head of threading buckle 52 is outside joint portion 510 and the tail is inside joint portion 510. The tail stopper 521 prevents threading buckle 52 from falling out of first through hole 513. For example, the shape of stopper foot 5210 can be arc-shaped to match the wall of joint portion 510, further reducing the volume occupied by joint portion 510.

[0109] Correspondingly, the first set of threading channels 520 for threading the same actuating wire 110 may all be located inside the wall of the joint portion 510, or may all be located outside the wall of the joint portion 510. For example, a portion of the actuating wires 110 may be arranged outside the wall of the joint portion 510, while another portion of the actuating wires 110 may be arranged inside the wall of the joint portion 510.

[0110] like Figure 19D A hook portion 5211 may be provided at the end of the limiting foot 5210. The limiting portion further includes a receiving portion 513a provided on the wall of the joint portion 510 and adjacent to the first through hole 513. The hook portion 5211 is inserted into the receiving portion 513a from the insertion direction of the threading buckle 52. The receiving portion 513a may be a groove or a through hole.

[0111] like Figures 19E-19H The threading buckle 52 can be made into a spring piece 522, which can be deformed under the action of external force and restore its deformation after the external force is removed. It includes wings 522a at both ends and a threading part 522b in the middle. The structure of the spring piece 522 can be the same as the above Figures 19A to 19C The embodiment shown is the same, but slightly different in usage. To distinguish it from the above embodiment and facilitate description, the reference numbers and names of the corresponding parts are changed. Among them, the wing portion 522a is similar to the limit foot 5210, and the threading portion 522b is similar to the arm of the threading buckle 52 connected to the limit foot 5210.

[0112] like Figure 19E The wing portions 522a at both ends are respectively limited by the limiting portion in the circumferential direction of the joint portion 510 (such as Figure 19EThe threading portion 522b at least partially surrounds the threading channel 520 at different positions (left and right directions) of the joint portion 510. The limiting portion includes a pair of insertion limiting portions 514 provided on the wall of the joint portion 510, and the wings 522a at both ends are respectively inserted into one insertion limiting portion 514 and then clamped by the wall of the joint portion 510. The limiting slot 514 is an interlayer slot provided in the wall of the joint portion 510, and the two limiting slots 514 are spaced apart in the circumferential direction of the joint portion 510 and face each other. When installing the threading buckle 52, first compress the threading portion 522b so that the wings 522a at both ends are close to each other, and the wings 522a at both ends are respectively aligned with the two limiting slots 514, and then release the threading portion 522b, so that the threading portion 522b recovers its deformation, and the wings 522a at both ends automatically snap into the limiting slots 514 on both sides. The drive wire 110 can be placed before the threading buckle 52 is installed, or it can be threaded after the threading buckle 52 is installed. It can be understood that after the external force is removed, the wings 522a at both ends may elastically abut against the two insertion limit portions 514, or may not elastically abut and simply be accommodated therein.

[0113] like Figure 19F The limiting slot 514 is a hole that passes through the wall of the joint portion 510. The installation method of the threading buckle 52 is the same as that of the threading buckle 52. Figure 19E The embodiment is the same. When the insertion limiting portion 514 is a hole, the wings 522a at both ends, while compressed, pass through the corresponding hole and then recover their deformation and expand, being limited by the wall on the other side of the joint portion 510. When the insertion limiting portion 514 is a slot defined in the interlayer within the wall, the wings 522a at both ends, while compressed, are inserted into the corresponding slot and then recover their deformation and expand, being prevented from falling out by the interlayer sidewall of the slot.

[0114] like Figure 19G The threading portion 522b between the wings 522a at both ends can also be made into an arched portion, for example, a semi-circular shape with an arc greater than 180 degrees, so that a V-shaped structure is formed between the threading portion 522b and the wings 522a on both sides. When the wings 522a at both ends are inserted into the limiting slots 514 on both sides, the V-shaped structure clamps the wall of the joint portion 510 therein, and can also prevent the threading buckle 52 from moving radially, especially Figure 19F The limiting slot 514 is shown as a hole.

[0115] like Figure 19HThe limiting portion includes an interlayer 515 provided on the wall of the joint portion 510, and the interlayer 515 includes a main body portion 516 and a notch portion 517 that divides the main body portion 516 into two parts. A mezzanine space M is formed between the left and right parts of the main body portion 516 and the wall of the joint portion 510, respectively, and the two mezzanine spaces M face each other along the circumference of the joint portion 510. When installing the spring piece 522, the spring piece 522 is first compressed so that the wings 522a at both ends approach each other until the distance between them allows them to be inserted into the left and right mezzanine spaces M. When the wings 522a are compressed to a certain extent, the external force is removed, and the wings 522a at both ends are inserted into the left and right mezzanine spaces M. In order to prevent part 522a from sliding out from above, the two parts of the main body 516 respectively include an anti-slip portion 518 extending toward the notch portion 517. After the threading portion 522b of the spring piece 522 is compressed, the wings 522a at both ends are respectively inserted into an interlayer space M, and the wings 522a are restricted from slipping out by the anti-slip portion 518.

[0116] It can be understood that the wing portion 522a of the spring piece 522 can be inserted between the interlayer 515 and the wall of the joint portion 510 along the axial direction (from the top downward as shown in Figure 19H) through the anti-slip portion 518. When the threading portion 522b is not compressed, the distance between the inner sides of the wing portions 522a is greater than the width of the notch portion 517. When the threading portion 522b is compressed, the distance between the inner sides of the wing portions 522a is less than the width of the notch portion 517. The wing portions 522a can be inserted between the anti-slip portion 518 and the joint portion 510 in the axial direction (from the top downward as shown in Figure 19H). The gap between the walls of the node 510 slides into the interlayer space M, and after the external force applied to the threading portion 522b is removed, the threading portion 522b recovers its deformation, and the wings 522a on both sides open and are completely confined in the corresponding interlayer space M; or, in some embodiments, the threading portion 522b can be directly compressed to the point where the distance between the outer sides of the wings 522a is less than the inner edge spacing of the left and right interlayer spaces M, and then it is aligned with the left and right interlayer spaces M and then inserted under the deformation recovery force.

[0117] It is understood that the above-mentioned various embodiments can be combined with each other. For example, Figure 19H The structure of the wall of the joint portion 510 can be Figures 19E-19G The threading channel 520 can also be formed by a closed annular structure. For example, the threading channel 520 can be located outside the joint portion 510 after installation; the threading buckle 52 and the limit portion structure in the first tube 111 can include one or more of the above.

[0118] The first tube 111 of this embodiment can be of various structural shapes. Figures 16-17 shows a structure of the first tube body 111, Figures 20-21C Another structure of the first tube is shown. Figures 22-23C shows another structure of the first tube body, Figure 24 Another configuration of the first tube is shown.

[0119] like Figures 16-17 In this embodiment, the nodes 511 are constructed as connecting beams 511a. Each pair of adjacent joints 510 is fixedly connected by two connecting beams 511a located on different radial sides. In other embodiments, the number of connecting beams 511a can be appropriately increased, such as to three, four, or more. For example, two adjacent connecting beams 511a can be provided on one radial side.

[0120] Exemplarily, the width of the connecting beam 511a at the proximal end of the joint body 51 is greater than the width of the connecting beam 511a at the distal end of the joint body 51, so that under the drive of the drive wire, the distal end of the joint body 51 bends first, which is more in line with anatomical characteristics. For example, the closer the connecting beam 511a is to the distal end of the joint body 51, the smaller its width is, showing a linear decreasing trend; or, the joint body 51 has multiple curvature change sections, and the width of the connecting beam 511a in each curvature change section is the same, and the closer the connecting beam 511a is to the distal end of the joint body 51, the smaller its width is, showing a step-by-step decreasing trend. In addition, the length of the connecting beam 511a at the proximal end of the joint body 51 can also be set to be smaller than the length of the connecting beam 511a at the distal end of the joint body 51. For example, the length of the connecting beam 511a can be linearly changed or stepped to achieve a similar effect.

[0121] The connecting beam 511a can be formed by cutting and forming an integral part with the joint body 51, and the two sides of the connecting beam 511a are hollowed out to form arc-shaped deformation holes H1 and deflection intervals H2 connecting the deformation holes H1. The deflection interval H2 separates the two adjacent joint sections 510 in the axial direction, so that when the connecting beam 511a is driven to bend, the distance between the two adjacent joint sections 510 on both sides of the connecting beam 511a (i.e., the deflection interval H2) changes. By setting the surface of the joint section 510 facing the deflection interval H2 as a flared inclined surface, the two adjacent joint sections 510 can be brought closer together at the same deflection interval H2, and the joint body 51 can achieve a greater bending deformation at this location. For example, from the proximal end to the distal end of the joint body 51, the deflection interval H2 can also be set to increase linearly or stepwise, so that the distal end of the joint body 51 has a greater bending deformation.

[0122] like Figures 20-21CIn this embodiment, the node 511 includes a male connector 5111 and a female connector 5112, respectively provided on two adjacent joint sections 510. The male connector 5111 is at least partially rotatably inserted into the first concave surface 5112a of the female connector 5112 via a first convex surface 5111a. The first convex surface 5111a and the first concave surface 5112a face each other, and both first concave surfaces 5112a are inclined relative to the rotation centerline of the male connector 5111, and are both inclined toward the outside of the joint section 510 or toward the inside of the joint section 510.

[0123] The male connector 5111 and the female connector 5112 face each other. The free end of the male connector 5111 is disc-shaped, and the edge of the disc has a C-shaped first convex surface 5111a. The free end of the female connector 5112 has a groove that is complementary to the disc shape. The groove has a first concave surface 5112a and a notch 5112c that communicates with the first concave surface 5112a. The first convex surface 5111a is embedded in the first concave surface 5112a and is loosely fitted therewith. At least a portion of the notch 5112c accommodates the non-free end of the male connector 5111 and utilizes its wall ( Figure 21C The upper and lower walls (in the middle) limit the angular range of rotation of the first convex arc surface 5111a within the first concave arc surface 5112a.

[0124] Exemplarily, there are two nodes 511 located on different radial sides between two adjacent joint portions 510. In the two nodes 511 located on different radial sides, the first convex arc surface 5111a and the first concave arc surface 5112a of each node 511 are inclined surfaces facing each other. The two first concave arc surfaces 5112a are inclined relative to the rotation center line of the male connector 5111 where they are located, and are both inclined toward the outside of the joint portion 510 or toward the inside of the joint portion 510. Figure 21B 、 21C The first concave arc surface 5112a is a chamfered surface facing the outside of the joint portion 510, and the first convex arc surface 5111a is a chamfered surface facing the inside of the joint portion 510, and the angles of the two are basically complementary. Figure 21B 、 21C As shown, since the two first convex arc surfaces 5111a opposite to each other in the radial direction are inclined toward the inside of the joint portion 510, and the two first concave arc surfaces 5112a are inclined toward the outside of the joint portion 510, Figure 21C As shown in the cross section, a single first convex arc surface 5111a forms a disc-shaped structure with a small inner portion and a large outer portion, and a single first concave arc surface 5112a forms an inverted conical through hole with a small inner portion and a large outer portion. When two adjacent joint portions 510 have a tendency to move relative to each other in the radial direction, the two first concave arc surfaces 5112a both prevent the first convex arc surface 5111a that matches them from moving radially inward. The clearance between the two allows relative rotation within a certain angle range. This structure can be formed into an integrated structure by laser cutting, for example Figure 21C As shown, laser cutting is used to achieve rotational symmetry between the two nodes 511 about the center of the joint portion 510. Therefore, the male connector 5111 and the female connector 5112 on the two adjacent sections of the joint portion 510 formed by the cutting remain connected as a whole. It is understood that when both first concave arc surfaces 5112a are tilted inward to form a tapered through hole that is larger on the inside and smaller on the outside, the male connector 5111 and the female connector 5112 can also be connected as a whole without separation.

[0125] For example, the angular range of rotation of the first convex curved surface 5111a at the distal end of the joint assembly within the first concave curved surface 5112a is greater than the angular range of rotation of the first convex curved surface 5111a at the proximal end of the joint assembly within the first concave curved surface 5112a. For example, the angular range of rotation of the first convex curved surface 5111a within the first concave curved surface 5112a gradually increases linearly or in steps from the proximal end toward the distal end of the joint assembly.

[0126] In addition to the mating of the first convex curved surface 5111a and the first concave curved surface 5112a, the female connector 5112 of this embodiment may further include a first C-shaped arm C1, with the first concave curved surface 5112a disposed on the inner edge of the first C-shaped arm C1 and a second convex curved surface 5112b disposed on the outer edge of the first C-shaped arm C1. Correspondingly, the node 511 also includes a second concave curved surface 5111b extending from both sides of the non-free end of the male connector 5111 and concentric with the first convex curved surface 5111a. The first convex curved surface 5111a, the first concave curved surface 5112a, the second concave curved surface 5111b, and the second convex curved surface 5112b are concentrically disposed, with the second convex curved surface 5112b and the second concave curved surface 5111b being loosely mated. The annular tube may be separated by laser cutting. For example, the second convex arc surface 5112b and the second concave arc surface 5111b may also be inclined surfaces facing each other. Figure 21B What is shown is that the second concave arc surface 5111b and the second convex arc surface 5112b are inclined relative to the rotation center line of the male connector 5111, and the second concave arc surface 5111b is inclined toward the outside of the joint part 510, and the second convex arc surface 5112b is inclined toward the inside of the joint part 510. In other embodiments, the second concave arc surface 5111b may be inclined toward the inside of the joint part 510, and the second convex arc surface 5112b may be inclined toward the outside of the joint part 510. The two groups of second convex arc surfaces 5112b and second concave arc surfaces 5111b arranged opposite to each other in the radial direction can also prevent radial separation.

[0127] The inner and outer edges of the first C-shaped arm C1 are the first concave arc surface 5112a and the second convex arc surface 5112b, and a notch 5112c is formed at its free end. The upper / lower walls of the non-free end of the male connector 5111 respectively form two arc-shaped grooves with the second concave arc surface 5111b and the first convex arc surface 5111a for accommodating the first C-shaped arm C1. The second concave arc surface 5111b and the first convex arc surface 5111a serve as the inner and outer arc surfaces of the arc groove. When the male connector 5111 rotates relative to the female connector 5112, the arc groove serves as a guide part to guide the sliding of the first C-shaped arm C1. The curvature of the arc groove between the end surface of the notch 5112c of the first C-arm C1 and the upper / lower walls of the non-free end of the male connector 5111 is used to limit the rotation angle of the male connector 5111 relative to the female connector 5112.

[0128] Exemplarily, compared to the proximal end of the joint body 51, the sum of the arc of separation (also referred to as the arc groove arc) θ1+θ2 between the free end of the first C-arm C1 and the side of the male connector 5111 on the distal side of the joint body 51 is larger. Alternatively, compared to the proximal end of the joint body 51, the joint cut angle θ3+θ4 between the two adjacent joint portions 510 on the distal side of the joint body 51 is larger. Here, the upper and lower arc of separation θ1 and θ2 are equal, and θ3 and θ4 are equal. In other embodiments, θ1 and θ2 may also be unequal, and θ3 and θ4 may also be unequal. The above arrangement can allow the distal joint portion 510 to have a larger bending angle.

[0129] For example, from the proximal end to the distal end of the joint body 51, the sum of the radians θ1+θ2 between the free end of the first C-shaped arm C1 and the side of the male connector 5111 (or the joint angles θ3+θ4 between two adjacent joint parts 510) gradually increases; or, the joint body 51 is divided into multiple sections, and the sum of the radians θ1+θ2 between the free end of the first C-shaped arm C1 and the side of the male connector 5111 (or the joint angles θ3+θ4 between two adjacent joint parts 510) in each section is equal, but the closer to the distal end of the section, the greater the sum of the radians θ1+θ2 between the free end of the first C-shaped arm C1 and the side of the male connector 5111 (or the joint angles θ3+θ4 between two adjacent joint parts 510).

[0130] like Figures 22-23CIn this embodiment, the free end of the male connector 5111 further includes a second C-shaped arm C2, which is disposed on the periphery of the first convex curved surface 5111a. A second concave curved surface 5111b is disposed on the inner edge of the second C-shaped arm C2. A third convex curved surface 5111c is disposed on the outer edge of the second C-shaped arm C2. The third convex curved surface 5111c is concentric with the second concave curved surface 5111b and the first convex curved surface 5111a. The second C-shaped arm C2 and the edge of the disc form a space for accommodating and rotating the first C-shaped arm C1. To match the outer edge of the second C-shaped arm C2, the node 511 also includes a third concave curved surface 5112d extending from the upper and lower sides of the non-free end of the female connector 5112 and concentric with the first concave curved surface 5112a. The third convex curved surface 5111c is clearance-fitted with the third concave curved surface 5112d.

[0131] During the relative rotation of the male connector 5111 and the female connector 5112, the notch at the end of the second C-shaped arm C2 cooperates with the non-free end of the female connector 5112. When the arc angle θ'1 (or θ'2) between the notch and the non-free end of the female connector 5112 (i.e., the non-free end of the first C-shaped arm C1) is smaller than the arc angle θ1 (or θ2) between the notch 5112c of the first C-shaped arm C1 and the non-free end of the male connector 5111, the second C-shaped arm C2 can be used to mate with the female connector 5111. The non-free end of the female connector 5112 cooperates with the third convex curved surface 5111c to limit the angular range of rotation within the third concave curved surface 5112d. Conversely, when the arc angle θ'1 (or θ'2) between the notch and the non-free end of the female connector 5112 is greater than the arc angle θ1 (or θ2) between the notch 5112c of the first C-shaped arm C1 and the non-free end of the male connector 5111, the angular range of rotation of the first convex curved surface 5111a within the first concave curved surface 5112a is limited by the first C-shaped arm C1. The first C-shaped arm C1 cooperates with the second C-shaped arm C2 and the first concave curved surface 5112a of the male connector 5111 to achieve a more stable rotation guidance function.

[0132] For example, when the third convex curved surface 5111c and the third concave curved surface 5112d are inclined surfaces facing each other, the effect of restricting radial disengagement of the two adjacent joint sections 510 can be further enhanced. The two third concave curved surfaces 5112d can both be inclined toward the outside of the joint section 510, or can both be inclined toward the inside of the joint section 510.

[0133] For example, the sum of the arcs θ'1+θ'2 between the free end of the second C-shaped arm C2 and the side of the female connector 5112 is larger at the distal end of the joint body 51 than at the proximal end of the joint body 51. Specifically, the sum of the arcs θ'1+θ'2 between the free end of the second C-shaped arm C2 and the side of the female connector 5112 increases gradually from the proximal end to the distal end of the joint body 51; or, the joint body 51 is divided into a plurality of sections, and the sum of the arcs θ'1+θ'2 between the free end of the second C-shaped arm C2 and the side of the female connector 5112 is equal in each section, but the sum of the arcs θ'1+θ'2 between the free end of the second C-shaped arm C2 and the side of the female connector 5112 increases as the section approaches the distal end.

[0134] It should be understood that the above embodiment only shows the situation where the female connector 5112 has one C-shaped arm and the male connector 5111 and the female connector 5112 each have one C-shaped arm. In other embodiments, the number of C-shaped arms on the male connector 5111 and the female connector 5112 can be increased, and it is only necessary to ensure that the corresponding arc surfaces on the male and female connectors are concentric.

[0135] like Figure 24 Unlike the previously described integrated joint body, the joint body in this embodiment is composed of multiple, split joint sections 510 connected together. The nodes 511 serve as hinge axes, and each pair of adjacent joint sections 510 is articulated via two radially symmetrical hinge axes. The threading buckle 52 is formed as a raised portion recessed within the joint section 510. This threading buckle 52 can be integrally stamped onto the wall of the joint section 510. In other embodiments, the threading buckle 52 can be secured to the wall of the joint section 510 by welding or other methods.

[0136] In the description of this specification, the reference terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and features of different embodiments or examples without contradiction.

[0137] Although the embodiments of the present invention have been shown and described above, it will be understood that the above embodiments are illustrative and are not to be construed as limitations on the present invention. A person skilled in the art may change, modify, replace and modify the above embodiments within the scope of the present invention.

Claims

1. A joint assembly for use in a flexible surgical instrument, characterized in that: include: Joint (510); Nodes (511), two adjacent joint portions (510) include two nodes (511) located on different radial sides thereof, the adjacent joint portions (510) are configured to be relatively rotatable around the node (511) therebetween, and the node (511) includes a male connector (5111) and a female connector (5112) respectively provided on the two adjacent joint portions (510); The male connector (5111) is at least partially rotatably inserted into the first concave surface (5112a) of the female connector (5112) through the first convex surface (5111a); the first convex surface (5111a) and the first concave surface (5112a) face each other, and the two first concave surfaces (5112a) are both inclined relative to the rotation center line of the male connector (5111), and are both inclined toward the outside of the joint part (510) or toward the inside of the joint part (510).

2. The joint assembly according to claim 1, wherein: The free end of the male connector (5111) includes the first C-shaped convex arc surface (5111a), and the female connector (5112) includes the first concave arc surface (5112a) and a notch (5112c) communicating with the first concave arc surface (5112a); The first convex arc surface (5111a) is embedded in the first concave arc surface (5112a) and is loosely fitted therewith, and the notch (5112c) is configured to at least partially accommodate the non-free end of the male connector (5111) and limit the angular range of rotation of the first convex arc surface (5111a) within the first concave arc surface (5112a).

3. The joint assembly according to claim 1, wherein: The female connector (5112) comprises a first C-shaped arm (C1), wherein the first C-shaped arm (C1) has a second convex arc surface (5112b) on the outer edge; The node (511) further includes a second concave arc surface (5111b) extending from both sides of the non-free end of the male connector (5111) and concentric with the first convex arc surface (5111a), and the second convex arc surface (5112b) is clearance-fitted with the second concave arc surface (5111b).

4. The joint assembly according to claim 3, characterized in that The second convex arc surface (5112b) and the second concave arc surface (5111b) are inclined surfaces facing each other.

5. The joint assembly according to claim 3, characterized in that The free end of the male connector (5111) includes a second C-shaped arm (C2), and the second C-shaped arm (C2) has a third convex arc surface (5111c) on the outer edge; The node (511) further includes a third concave arc surface (5112d) extending from both sides of the non-free end of the female connector (5112) and concentric with the first concave arc surface (5112a), and the third convex arc surface (5111c) is clearance-fitted with the third concave arc surface (5112d).

6. The joint assembly according to claim 1, wherein: The angular range of rotation of the first convex arc surface (5111a) located at the distal end of the joint assembly within the first concave arc surface (5112a) is greater than the angular range of rotation of the first convex arc surface (5111a) located at the proximal end of the joint assembly within the first concave arc surface (5112a).

7. The joint assembly according to any one of claims 1 to 6, characterized in that: Along the length direction of the joint component, two adjacent nodes (511) are staggered in the circumferential direction of the joint component.

8. A catheter, characterized in that It comprises a driving wire (110), a flexible second tube (112) and a joint assembly according to any one of claims 1 to 7, wherein the joint assembly is connected to the distal end of the second tube (112), one end of the driving wire (110) is arranged at the distal end of the joint assembly, and the other end passes through the corresponding threading channel (520) on the joint assembly in sequence along the length direction and is then led out to the proximal end of the second tube (112).

9. The catheter according to claim 8, characterized in that It also includes a connecting ring (113) connecting the joint assembly and the second tube body (112), the distal outer wall of the connecting ring (113) is provided with a plurality of thickened portions (1131), and the proximal end of the joint assembly is provided with an installation slot (111C) configured to be inserted into the thickened portion (1131).

10. The catheter according to claim 9, characterized in that It also includes an elastic tube (110a) that is sleeved outside the driving wire (110) and can be compressed in the axial direction. The inner surface of the thickened portion (1131) is provided with an axially extending receiving groove (1132), and the elastic tube (110a) and / or the driving wire (110) are at least partially received in the receiving groove (1132).

11. A flexible surgical instrument, characterized in that: The invention comprises an outer sheath (20) and the catheter according to any one of claims 8 to 10, wherein the catheter is configured to be detachably inserted into and removed from the outer sheath (20).

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