WO2024017109A1 - 柔性手术器械、导管及关节组件 - Google Patents

柔性手术器械、导管及关节组件 Download PDF

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Publication number
WO2024017109A1
WO2024017109A1 PCT/CN2023/106947 CN2023106947W WO2024017109A1 WO 2024017109 A1 WO2024017109 A1 WO 2024017109A1 CN 2023106947 W CN2023106947 W CN 2023106947W WO 2024017109 A1 WO2024017109 A1 WO 2024017109A1
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WO
WIPO (PCT)
Prior art keywords
joint
threading
limiting
parts
catheter
Prior art date
Application number
PCT/CN2023/106947
Other languages
English (en)
French (fr)
Inventor
陈正坤
刘放
王建辰
Original Assignee
深圳市精锋医疗科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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Publication of WO2024017109A1 publication Critical patent/WO2024017109A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/008—Articulations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/0034—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means adapted to be inserted through a working channel of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a flexible surgical instrument, a catheter and a joint assembly.
  • Minimally invasive surgery can be performed through natural orifices on the surface of 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, to target locations in the patient's body.
  • minimally invasive surgery can equip the minimally invasive medical device with an endoscope.
  • the endoscope allows the device to provide the doctor with a useful display during insertion, removal, or medical procedures. View of tissues, organs and/or instruments.
  • the slender, flexible tool that houses the endoscope can be inserted into the patient's mouth and passed through the patient's throat into the trachea, lung airways, and lungs, allowing the doctor to examine the patient's lung air.
  • the internal condition of tracts such as bronchi and bronchioles, allowing doctors to perform diagnostic and/or medical procedures.
  • Surgical tools such as endoscopes are usually configured at the distal end of different slender flexible tools.
  • the slender flexible tools are driven from outside the patient's body and deformed as needed in the body, such as in narrow tracts.
  • the structural design of the slender flexible tools requires Ensure the compact structure of the product to reduce its space occupation.
  • the present invention provides a flexible surgical instrument, catheter and joint assembly, which can ensure the compact structure of the product so that it can be driven as needed to flexibly deform in the patient's body.
  • a joint assembly for use in flexible surgical instruments including:
  • the joint body includes a multi-section joint part, a node connecting two adjacent sections of the joint part, and a plurality of limiting parts spaced apart along the length direction on the joint body;
  • a plurality of threading buckles the threading buckle is provided on the limiting part and is provided with a threading channel for the driving wire to pass through, and at least one of the threading buckles is detachably fixed on the limiting part;
  • the adjacent joint parts are configured to produce relative deflection around a node between them under the tension of the driving wire.
  • the limiting part includes a first through hole penetrating the wall of the joint part, and the threading buckle includes a head provided with the threading channel and a tail provided with a blocking part;
  • the size of the threading buckle is configured to allow the head portion to pass out of the first through hole and to restrict the blocking portion from passing through the first through hole.
  • the threading buckle is wedge-shaped.
  • the blocking part includes two limiting feet at the tail of the threading buckle, and the two limiting feet are opened toward each other and restricted from entering the third through hole by the edge of the first through hole. A through hole.
  • the threading buckle includes an elastic piece, and the elastic piece includes wing parts at both ends and a threading part in the middle;
  • the wings at both ends are respectively limited by the limiting portion at different positions in the circumferential direction of the joint portion, and the threading portion at least partially encloses the threading channel.
  • the limiting part includes a pair of insertion limiting parts provided on the wall of the joint part, and the pair of limiting slots are holes or grooves, and are formed around the joint part. set upward;
  • the wings at both ends are respectively inserted into one of the insertion limiting parts and then held by the wall of the joint part.
  • the limiting part includes an interlayer provided on the wall of the joint part, and the interlayer includes a main body part and a gap part that divides the main body part into two parts;
  • An interlayer space is formed between the two parts of the main body part and the wall of the joint part respectively, and the two interlayer spaces face each other along the circumferential direction of the joint part;
  • the two parts of the main body each include an anti-separation portion extending toward the notch; the elastic piece is configured such that after the threading portion is compressed, the wings at both ends are inserted into one of the sandwich spaces, and Detachment from the interlayer space is restricted by the detachment prevention part.
  • the first set of threading channels for threading one of the drive wires are located in the wall of the joint part, and/or, the first set of threading channels for threading one of the drive wires are located in the wall of the joint part.
  • the second set of threading channels are located outside the wall of the joint.
  • the node includes a connecting beam, and each two adjacent sections of the joint portion are fixedly connected by at least two connecting beams located on different sides in the radial direction;
  • the width of the connecting beam at the proximal end of the joint body is greater than the width of the connecting beam at the distal end of the joint body, and/or the length of the connecting beam at the proximal end of the joint body is shorter than the length of the connecting beam at the distal end of the joint body. length.
  • Another object of the present invention is to provide a catheter, which includes a drive wire, a flexible second tube body and the above-mentioned joint component.
  • the joint component is connected to the distal end of the second tube body.
  • the drive wire One end is provided at the distal end of the joint component, and the other end passes through the corresponding threading channel on the joint component in sequence along the length direction and is led out to the proximal end of the second tube body.
  • the catheter further includes a connecting ring connecting the joint component and the second tube body.
  • the distal outer wall of the connecting ring is protrudingly provided with a plurality of thickened portions.
  • the proximal end is provided with an installation slot configured for the thickened portion to be inserted.
  • the catheter further includes an elastic tube that is sleeved outside the driving wire and can be compressed in the axial direction, and the inner surface of the thickened portion is provided with an axially extending receiving groove.
  • the elastic tube and/or the driving wire are at least partially accommodated in the accommodation groove.
  • Yet another object of the present invention is to provide a flexible surgical instrument, including an outer sheath and a catheter as described above, the catheter being configured to detachably insert and withdraw the outer sheath.
  • the threading buckle of the present invention is detachably installed on the limiting part of each section of the joint body.
  • the flexibility can be changed by simply adjusting the tension applied to the driving wire.
  • the curved shape of the joint component does not significantly increase the diameter of the conduit, ensuring the compact structure of the product.
  • Figure 1 is a schematic structural diagram of a flexible surgical instrument according to an embodiment of the present invention
  • Figure 2 is a simplified structural schematic diagram of a catheter in a non-bent state according to an embodiment of the present invention
  • Figure 3 is a simplified structural schematic diagram of a flexible surgical instrument in a bent state according to an embodiment of the present invention
  • Figure 4 is a schematic structural diagram of a tip portion according to an embodiment of the present invention.
  • Figure 5A is an exploded schematic diagram of a partial structure of a catheter according to an embodiment of the present invention.
  • Figure 5B is a partial structural schematic diagram of a catheter according to an embodiment of the present invention.
  • Figure 6 shows a schematic diagram of the internal structure of an outer sheath according to an embodiment of the present invention
  • Figure 7A is a schematic diagram of the alignment method of a catheter according to an embodiment of the present invention.
  • Figure 7B shows a schematic diagram of another catheter alignment method according to an embodiment of the present invention.
  • Figure 7C shows a schematic diagram of yet another catheter alignment method according to an embodiment of the present invention.
  • Figure 8A shows a schematic structural diagram of the interior of a catheter according to an embodiment of the present invention.
  • Figure 8B shows a schematic diagram of the cooperation mode between a connecting ring and the first pipe body according to the embodiment of the present invention
  • Figure 8C shows a schematic diagram of the cooperation mode between a connecting ring and the second pipe body according to the embodiment of the present invention
  • Figure 9 shows a schematic diagram of the distal end structure of a catheter with a built-in instrument according to an embodiment of the present invention.
  • Figure 10 shows an exploded schematic diagram of the structure of Figure 9
  • Figure 11 shows a schematic diagram of the distal structure of another catheter with built-in instruments according to an embodiment of the present invention
  • Figure 12 shows a schematic diagram of the distal structure of yet another catheter with built-in instruments according to an embodiment of the present invention
  • Figure 13 shows a schematic diagram of the distal structure of yet another catheter with built-in instruments according to an embodiment of the present invention
  • Figure 14 is a schematic structural diagram of an image acquisition component according to an embodiment of the present invention.
  • Figure 15 is a schematic structural perspective view of a tip portion according to an embodiment of the present invention.
  • Figure 16 shows a schematic structural diagram of the first first pipe body according to the embodiment of the present invention.
  • Figure 17 is an enlarged view of point A in Figure 16;
  • Figure 18A shows a schematic diagram of the installation method of the threading buckle of Figure 16
  • Figure 18B shows a schematic diagram of the threading method of the driving wire in the first tube body
  • FIGS 19A to 19H show schematic diagrams of the installation methods of several different threading buckles according to embodiments of the present invention.
  • Figure 20 shows a schematic structural diagram of the second first pipe body according to the embodiment of the present invention.
  • Figure 21A shows a front view of the first tube body shown in Figure 20;
  • Figure 21B is an enlarged view of position B in Figure 21A;
  • Figure 21C is a schematic cross-sectional view of Figure 21B;
  • Figure 22 shows a schematic structural diagram of the second first pipe body according to the embodiment of the present invention.
  • Figure 23A shows a front view of the second tube body shown in Figure 22;
  • Figure 23B is an enlarged view of position C in Figure 23A;
  • Figure 23C is a schematic cross-sectional view of Figure 23B;
  • Figure 24 shows a schematic structural diagram of the third first pipe body according to the embodiment of the present invention.
  • first and second are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of indicated technical features. Therefore, features defined as “first” and “second” may explicitly or implicitly include one or more of these features.
  • “plurality” means two or more than two, unless otherwise explicitly and specifically limited.
  • an embodiment of the present invention provides a flexible surgical instrument.
  • the flexible surgical instrument 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, and the catheter 10 is configured to detachably insert and extract the outer sheath 20 along the insertion channel 21, thereby entering a predetermined position in the body or from a predetermined position. quit.
  • both the catheter 10 and the outer sheath 20 have an elongated tubular structure, and the main part is made of flexible material.
  • both the catheter 10 and the outer sheath 20 can use drive wires arranged along their lengths to control the degree of freedom of their distal ends, thereby changing the shape, stiffness and orientation of the distal end of the slender tube.
  • Such drive enables the operator to control the movement of the distal end of the elongated tube at the proximal end of the elongated tube located outside the body.
  • two drive wires arranged radially opposite to each other in one of the elongated tubes can provide a degree of freedom in a certain direction (such as pitch), and four drive wires arranged opposite to each other in two different radial directions of the elongated tube can provide More degrees of freedom in 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 the catheter 10 with more degrees of freedom.
  • the number of driving wires is not limited to this and can be adjusted as needed.
  • FIG. 2 shows a simplified structural schematic diagram of the catheter in a non-bent state
  • Figure 3 shows a simplified structural schematic diagram of the flexible surgical instrument in a bent state.
  • this embodiment provides a catheter 10 for a flexible surgical instrument.
  • the catheter 10 includes a catheter body 11 , a channel tube 12 , an image acquisition component 13 and a tip 14 .
  • the catheter body 11 serves as the main part of the catheter 10 , with reference to Figures 4 and 5, the channel tube 12 is located in the catheter body 11, the image acquisition component 13 includes an image device and its signal line L, the signal line L is located in the gap between the channel tube 12 and the catheter body 11, the image The device is accommodated and fixed in the tip portion 14 .
  • the tip 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 received in the second through hole 141 , and the proximal end of the tip 14 is protruding.
  • There is a connecting ring 143 which protrudes toward the channel tube 12 along the edge of the first through hole 142.
  • 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 (as shown in the figure). 3 as shown by the dotted line).
  • the adapter ring 143 may have an inner wall coplanar with the first through hole 142, thereby forming a smooth instrument working channel.
  • the catheter 10 Since the image device is integrated in the tip 14 and the signal line L is routed in the gap between the channel tube 12 and the catheter body 11, the catheter 10 has both a working channel for the instrument and the function of an endoscope, and can be used with
  • the outer sheath 20 cooperates to guide the movement of the outer sheath 20 in the human body, and can also provide a working channel and a movement carrier for the internal equipment to enter and exit.
  • the internal equipment extends out of the working channel, it can also provide a movement view of the internal equipment, thereby utilizing a small
  • the slender tube structure realizes multiple functions, improves the compactness of the structure, and reduces the space requirements for the surgical process.
  • the channel tube 12 is sleeved on the outer surface of the connecting ring 143 to communicate with the first through hole 142 , which can provide a stronger connection performance.
  • the channel tube 12 is not easily peeled off from the tip portion 14, which prevents human blood, mucus and other fluids from entering through the peeling point, and can also achieve a better waterproof effect.
  • the image device shown in this embodiment includes an image module 13a and two light sources 13b.
  • the two light sources 13b are respectively provided on both sides of the image module 13a, and are used for locating the image module 13a.
  • the environment provides supplementary light.
  • the image module 13a and the light source 13b are embedded in the tip portion 14 at the same time and are located in different second through holes 141.
  • the second through hole 141 includes a module hole 141a and a module hole 141a.
  • the light source holes 141b on both sides of the hole 141a, the image module 13a and the two light sources 13b are respectively inserted into the corresponding through holes from the proximal end of the tip 14, and fixed through interference fit, and/or bonded with adhesive.
  • the diameter of the first through hole 142 is larger than that of the second through hole 141 , and the second through hole 141 is provided at intervals around the periphery of the first through hole 142 to rationally utilize the product space.
  • each light source 13b can be located on the same side of the image module 13a.
  • At least one of the image module 13 a and the two light sources 13 b may also have only its distal end embedded in the tip 14 , and its proximal end located in the gap between the catheter body 11 and the channel tube 12 .
  • the tip portion 14 in addition to the connecting ring 143 , also includes a ring surrounding the connecting ring 143 , the second through hole 141 and the first through hole 142 .
  • side 144, the connecting ring 143, the flange 144, and the proximal surface of the tip portion 14 form an annular space, and the distal end of the catheter body 11 is installed between the connecting ring 143 and the flange 144.
  • the flange 144 may be a ring of rims, or may be multiple segments of rims spaced apart in the circumferential direction.
  • the outer circumferential surface of the distal end of the catheter body 11 can be interference-fitted with the inner wall of the flange 144, and the two can also be bonded by an adhesive. Reinforcement; for another example, the diameter of the outer circumferential surface of the catheter body 11 near the distal end is slightly smaller to form a step portion.
  • the catheter body 11 is inserted into the flange 144 and uses the step portion to abut against the end surface of the flange 144 to limit the further movement of the catheter body 11 insert.
  • the distal end surface of the catheter body 11 does not contact the proximal surface of the tip portion 14 located between the connecting ring 143 and the flange 144, but maintains a certain distance.
  • the distal end of the channel tube 12 can be an interference fit with the connecting ring 143.
  • the distal end of the channel tube 12 can be expanded and then put on the outer peripheral surface of the connecting ring 143, and the two can also be bonded and reinforced by adhesive.
  • 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 tip 14.
  • the positioning sensor 15 may include an EM (Electro Magnetic, electromagnetic) sensor.
  • EM Electro Magnetic, electromagnetic
  • the detection magnetic field can be generated by a magnetic field generator arranged on the side of the patient.
  • Flexible surgical instruments and medical equipment are components of medical equipment. When the position and angle of the EM sensor are different, Different currents are generated in the coils of the EM sensor to locate the position and orientation of the distal end of the catheter 10.
  • the positioning sensor can also be replaced by other sensing modules, such as light sensors, ultrasound probes, gyroscopes, etc. .
  • the orientation of the distal end of the catheter 10 can be obtained by using an EM sensor to calibrate the field of view direction of the image acquisition assembly 13 .
  • the tip portion 14 includes at least two recesses 145 extending through its proximal surface, and the distal end of the positioning sensor 15 is inserted into the recesses 145 . Since the catheter 10 is integrated with the positioning sensor 15, when the outer sheath 20 needs to be inserted into the body, the catheter 10 and the outer sheath 20 can be inserted simultaneously. The positioning sensor 15 is used to provide motion navigation for the outer sheath 20, and the image device on the catheter 10 can also be inserted into the body. Can provide it with vision.
  • the recess 145 is a groove that does not penetrate the distal end of the tip portion 14 .
  • the positioning sensor 15 is protected by the tip portion 14 and can avoid liquid contact with it.
  • the wires of the positioning sensor 15 are similar to the signal wires L of the image device. From the channel tube 12 The gap between the catheter body 11 and the catheter body 11 is led to the proximal end to transmit the position signal detected by the positioning sensor 15 .
  • the recess 145 may also be a through hole penetrating the distal end of the tip portion 14 , and the positioning sensor 15 can be seen from the distal end of the tip portion 14 .
  • the catheter 10 includes two EM sensors.
  • the axes of the two EM sensors are cross-arranged and form a certain angle with each other.
  • the distal ends of the two EM sensors extend away from each other.
  • Each EM sensor The movement of their respective points can be detected, and the combination of the two EM sensors can detect the deflection of the distal end of the catheter 10 .
  • the two positioning sensors 15 can respectively Located on two different sides of the image module 13a, each recess 145 is located between the module hole 141a and a light source hole 141b. It can be understood that in other embodiments, there can be one positioning sensor 15 or more than two, and the relative position of the positioning sensor 15 and the light source 13b can also be adjusted.
  • the distal end surface of the tip portion 14 includes a slope S that is inclined toward the outer peripheral surface.
  • the slope S can prevent the distal end of the tip 14 from scratching the tissue, and can also guide the catheter 10 to be inserted into the outer sheath 20 or into the body.
  • What is shown in the figure is a situation where part of the material is removed from one side of the tip 14 to form a unilateral slope S.
  • the slope S intersects the first through hole 142 and the image device and two EM sensors are located at the distal end of the tip 14
  • the wires of the two EM sensors and the signal line L are located on the same side of the channel tube 12 (the upper side as shown in FIG. 5 ) without the slope S (the upper side as shown in FIG. 5 ).
  • the slope S may be omitted or there may be more than one, but an installation area for the image module 13a needs to be reserved.
  • the outer sheath 20 includes a tube body 22 and an outer sheath driving wire 23.
  • the insertion channel 21 runs through the axial direction of the tube body 22.
  • a hollow channel 220 is provided on the wall of the tube body 22, and the outer sheath driving wire 23 passes through the hollow.
  • its distal end is fixed on the distal end of the tube body 22, and the proximal end is led out from the hollow channel 220 to the connecting wire driving mechanism.
  • a fixing ring 24 can be installed at the distal end of the tube body 22.
  • the fixing ring 24 is fixed in the wall of the tube body 22 in an embedded manner, and the distal end of the outer sheath driving wire 23 is fixed on the fixing ring 24, using The fixing ring 24 disperses the stress exerted by the outer sheath driving wire 23 on the wall of the tube body 22 .
  • the tube body 22 may 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 driving wire 23 acts, , the passive bending section will not or basically will not bend accordingly.
  • the tube body 22 can be a multi-layer composite structure.
  • the outer sheath driving wire 23 is inserted into the hollow channel 220 of the middle layer between the inner layer and the outer layer.
  • the inner wall of the hollow channel 220 can be made of PTFE (Poly tetra fluoroethylene) with lubricating effect. , that is, polytetrafluoroethylene) material to meet the lubrication needs of the drive wire movement.
  • Four outer sheath driving wires 23 may be provided in the tube body 22 to drive the pitch and yaw of the outer sheath.
  • Four hollow channels 220 are provided in the tube body 22 at intervals in the circumferential direction. It can be understood that in other embodiments, the number of outer sheath driving wires 23 can also be changed, and the tube body 22 can also be a single-layer structure.
  • the tip portion 14 may also include a first alignment portion 14V.
  • the catheter body 11 includes a second alignment portion 11V.
  • the second positioning portion 11V needs to be aligned and fitted with the first positioning portion 14V to ensure Ensure that the installation orientation of the image device is correct, and that after installation, the image device will not rotate out of position relative to the catheter body 11.
  • Figures 7A to 7C respectively show schematic diagrams of three different catheter alignment modes.
  • the first alignment part 14V is a notch groove opened in the flange 144
  • the second alignment part 11V is a first convex part protruding radially from the distal end of the catheter body 11.
  • the first alignment portion 14V is a strip-shaped convex portion provided on the inner wall of the flange 144
  • the second alignment portion 11V is a groove opened on the distal end surface of the catheter body 11 .
  • the strip-shaped protrusion is stuck into the groove.
  • the first alignment portion 14V is a slot opened on the proximal surface of the tip portion 14 between the connecting ring 143 and the flange 144
  • the second alignment portion 11V is an axial extension from the distal end of the catheter body 11 .
  • the second protrusion is inserted into the slot when the tip 14 is assembled to the distal end of the catheter body 11 .
  • first convex part and the second convex part may be bumps, convex pillars and other structures, and the first alignment part 14V and the second alignment part 11V may include one or a combination of the above,
  • the number of the first positioning part 14V and the second positioning part 11V may be more than one.
  • a plurality of the first positioning parts 14V/second positioning parts 11V may be spaced apart in the circumferential direction.
  • the catheter body 11 of this embodiment includes a flexible first tube body 111 and a driving wire 110 configured to drive the first tube body 111 to change the curvature.
  • the first tube body 111 includes a driving wire.
  • the limiting portion 1110, the driving wire limiting portion 1110 is close to the distal end of the first tube body 111 and is spaced from the distal end surface of the first tube body 111.
  • the driving wire 110 extends along the length direction of the catheter body 11 and the distal end is limited to On the side of the driving wire limiting portion 1110 facing the distal end 14 , for example, the distal end of the driving wire 110 is prevented from escaping from the driving wire limiting portion 1110 toward the proximal end through a stuck point or an enlarged end.
  • the driving wire limiting portion 1110 is not located at the distal end face of the catheter body 11 but is at a distance from the distal end face. This can prevent the distal end of the driving wire 110 from interfering with the structure of the proximal end of the tip portion 14 , thus protecting it to a certain extent.
  • Positioning sensor, image acquisition component 13 and other structures are provided.
  • 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 diameter than the second tube body 112. According to the bending curvature, the inner surface of the catheter body 11 may be provided with a threading portion 1100. The distal end of the driving wire 110 is limited by the driving wire limiting portion 1110, and its proximal end passes through the corresponding threading portion 1100 and is then led out from the proximal end of the catheter body 11.
  • the first tube body 111 serves as an active bending part and changes the curvature under the driving of the driving wire 110.
  • the second tube body 111 112 serves as a passive bending part and is driven by the first tube body 111 to deform.
  • the threading portion 1100 can be located on the outer surface of the catheter body 11 or penetrate the catheter wall.
  • the outer surface of the driving wire 110 is also covered with an elastic tube 110a that can be compressed in the axial direction (as shown in Figure 1).
  • the elastic tube 110a is always in an elastic compression state, when the tension force used for the driving wire 110 After being removed, the elastic tube 110a resumes its deformation, causing the catheter body 11 to return to its original shape, thereby improving the flexibility of the catheter 10.
  • the elastic tube 110a may be, for example, a spring tube, a plastic tube, or the like.
  • the elastic tube 110a does not need 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 relatively fixed to the two ends of the second tube body 112 respectively.
  • 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 on 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 both ends of the connecting ring 113 .
  • the distal outer wall of the connecting ring 113 is protrudingly provided with four thickened portions 1131.
  • the thickness of the thickened portions 1131 is greater than that of the catheter body 11.
  • the wall thickness in other areas forms bumps, and four thickened portions 1131 are spaced apart on the outer peripheral surface of the connecting ring 113 .
  • the proximal end of the first tube body 111 is provided with mounting slots 111C consistent with the position and number of the thickened portion 1131 .
  • the mounting slots 111C are configured as gaps penetrating the end and wall of the first tube body 111 , and the connecting ring 113 Both ends are inserted into the first tube body 111 and the second tube body 112 respectively.
  • the thickened portion 1131 of the connecting ring 113 is inserted into the corresponding installation slot 111C on the first tube body 111.
  • the far end of the elastic tube 110a The end is fixed on the inner wall of the thickened portion 1131.
  • each thickened portion 1131 is also provided with an axially extending receiving groove 1132, that is, the receiving groove 1132 is recessed from the inner wall of the connecting ring 113 into the thickened portion 1131.
  • the accommodating groove 1132 can be made closer to the outer wall of the first tube body 111 than the inner wall of the first tube body 111, and the elastic tube 110a and the driving wire 110 can be at least partially accommodated in the accommodating groove 1132, so that , the installation part of the elastic tube 110a and the driving wire 110 can occupy less internal space of the first tube body 111, and the driving wire 110 can be closer to the first tube body 111, making the structure of the catheter body 11 more compact, and can be used for other components. More design space is reserved for components such as wires and channel tubes 12 . It can be understood that the number of thickened portions 1131 can also be adjusted according to the number of driving wires 110 .
  • the flexible surgical instrument also includes an inner instrument 30 that is removably inserted into and extracted from the working channel 10H where the channel tube 12 is located.
  • the internal instruments 30 include, but are not limited to, various surgical instruments, such as cauterization instruments, clamping instruments, cutting instruments, suturing instruments, electric hooks, irrigation instruments, etc.
  • the internal instrument 30 shown in Figure 9 is an irrigation instrument.
  • a fluid channel 321 is opened in the axial direction of the internal instrument 30 for fluid to pass through.
  • a positioning sensor can be fabricated 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 navigation in real time during the flushing process.
  • the internal instrument 30 includes an elongated tube body 32 and a first positioning sensor 33.
  • the internal instrument 30 is configured to be detachably inserted into the working channel 10H.
  • the elongated tube body 32 is provided with a fluid channel throughout its length direction. 321.
  • the first positioning sensor 33 is fixed at the distal end of the elongated tube body 32 and is arranged adjacent to the fluid channel 321. Through the fluid channel 321, the injection and extraction of fluids such as flushing liquid can be realized.
  • the first positioning sensor 33 may be the same as the positioning sensor 15, including but not limited to an EM sensor, a light sensor, an ultrasonic probe, and a gyroscope.
  • the contours of the working channel 10H and the elongated tube body 32 match, and there is a gap fit between them.
  • the internal instrument 30 has at least two first positioning sensors 33.
  • the two first positioning sensors 33 generate different output signals in response to the magnetic field emitted by the magnetic field generator. According to the output signal of any one of the first positioning sensors 33
  • the position of the part where the first positioning sensor 33 is located can be known.
  • the relative positions of the two first positioning sensors 33 can be determined, thereby determining the orientation of the internal instrument 30 and realizing the internal instrument.
  • the detection of the position and orientation of the device 30 provides a basis for adjusting the direction of the internal device 30 .
  • the elongated tube body 32 is provided with an installation channel 322 that runs through its length direction and an arc-shaped partition 323 that runs through its length direction and arches toward the installation channel 322 .
  • the first positioning sensor 33 is fixed in the installation channel 322 inside, and the installation channel 322 and the fluid channel 321 are separated by the partition 323, the signal line of the first positioning sensor 33 can be led out from the installation channel 322 to the proximal end.
  • the volume of the first positioning sensor 33 is small, so the cross-sectional area of the fluid channel 321 is often larger than the installation channel 322 to ensure the flow of fluid.
  • the partition 323 has an arc-shaped thin wall, so that the fluid channel 321 and the installation channel 322 are isolated from each other.
  • the arch-shaped 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, so that The fluid channel 321 is at least partially disposed around the first positioning sensor 33 so that the cross-sectional area of the fluid channel 321 is as large as possible.
  • At least part 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 (as shown in FIG. 10, the upper wall of the fluid channel 321) can be designed to be in contact with the first positioning sensor 33.
  • the thin wall of the inner instrument 30 is contour-matched, for example, made into an arc shape that matches the outer wall of the elongated tube body 32.
  • the arc-shaped wall of the fluid channel 321 is thinner, and the cross-section of the fluid channel 321 enclosed by the arc-shaped wall is larger. This ensures channel flow.
  • the fluid channel 321 may not be disposed around the first positioning sensor 33 , but may only be disposed adjacent to the first positioning sensor 33 .
  • the partition 323 may also be flat or arched away from the installation channel 322 .
  • the inner instrument 30 may have anti-rotation features, where the anti-rotation features include a non-circular profile of the inner instrument 30 , that is, the cross-section of the working channel 10H is non-circular, such that the elongated tube 32 is in contact with the working channel 10H When the clearance fit is used, the elongated tube body 32 cannot rotate in the working channel 10H. That is, the cross section of the inner instrument 30 has different sizes in at least two different directions, and the cross section of the first through hole 142 has different sizes in at least two different directions.
  • the cross-sectional profile of the internal instrument 30 may be one or a combination of at least two of an oval, a crescent shape, a "D" shape, a sector (i.e., a "V" shape), a square, and the cross-sectional shape of the working channel 10H is consistent with the first
  • the cross-sectional shapes of the through holes 142 match.
  • the anti-rotation feature can also be such that the opposite sides have different shapes, for example, the upper surface is arc-shaped and the lower surface is square.
  • Figure 10 shows the internal instrument 30 and the cross-sectional profile of the working channel 10H being "D" shaped.
  • the image module 13a and the two light sources 13b are respectively located above and on the left and right sides of the working channel 10H.
  • the working channel 10H is close to the image module.
  • the surfaces of the group 13a and the two light sources 13b are flat, the image module 13a is close to the first positioning sensor 33, and the other surfaces are roughly arcuate;
  • Figure 11 shows the situation where the working channel 10H is waist-circular, and the upper and lower sides of the working channel 10H are The surface is curved, the left and right surfaces are flat, and the first positioning sensor 33 is located below and away from the image module 13a;
  • Figure 12 shows the situation where the working channel 10H is oval, and the working channel 10H is arranged transversely between the image module 13a and both sides. below the light source 13b.
  • the anti-rotation features may also include protrusions (or recesses) provided on the outer circumference of the inner instrument 30 , correspondingly, recesses (or protrusions) are provided on the inner wall of the working channel 10H , when the internal instrument 30 is inserted into the working channel 10H, the rotation of the internal instrument 30 is restricted by the cooperation between the convex part and the recessed part.
  • the protruding portion 324 on the outer peripheral surface of the internal device 30 runs through the length direction of the internal device 30 to form a ridge, and the first positioning transmitter
  • the sensor 33 and the installation channel 322 are at least partially located (that is, completely or partially located in the radial direction) within the convex strip.
  • the inner wall of the working channel 10H is correspondingly provided with a recessed portion 10h that runs through its length direction.
  • the convex portion 324 matches the recessed portion 10h, and can be used to guide the insertion process of the internal instrument 30, and can also be used to limit the relative rotation of the two.
  • the first positioning sensor 33 can also be partially or completely protruded outside the working channel 10H, to a certain extent. Increase the space of the working channel by 10H. In other embodiments, the first positioning sensor 33 may not be included in the protrusion, or the protrusion 324 on the outer circumferential surface of the inner device 30 does not penetrate the length direction of the inner device 30 but is only one or more protrusions. , or one or more bumps.
  • This anti-rotation feature can prevent the first positioning sensor 33 from rotating or being installed backwards, thereby achieving accurate navigation.
  • the first positioning sensor 33 can be formed only on the internal instrument 30, or the positioning sensors can be provided on the catheter 10 and the internal instrument 30 at the same time.
  • the positioning sensors on the two structures respectively realize the positioning of the catheter 10 and the internal instrument 30 respectively.
  • the position detection of the internal instrument 30 can determine the relative position of the two positioning sensors by working together to realize navigation of the catheter 10 and the internal instrument 30 of the flexible surgical instrument in different positions.
  • the flexible surgical instrument may not include the outer sheath 20 .
  • the image acquisition component includes a flexible circuit board 13c.
  • the image module 13a and the light source 13b are simultaneously located on the flexible circuit board 13c.
  • the signal line L Connect the flexible circuit board 13c to realize the integrated design of the image acquisition component.
  • the flexible circuit board 13c may have a base 13d and two branches 13e. The end contacts of each branch are respectively attached with a light source 13b.
  • the image module 13a is attached to another part of the base 13d between the two branches 13e. On one contact point, the proximal end of the tip portion 14 is also provided with a recessed portion 141c for the base portion 13d to be embedded.
  • 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 recess 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 recess 141c.
  • the first tube body 111 mainly includes a joint body 51 and a plurality of threading buckles 52.
  • the joint body 51 includes multiple annular sections.
  • Each threading buckle 52 is provided with a threading channel 520 for the driving wire 110 to pass through.
  • Each threading buckle 52 is detachably fixed on a different limiting part.
  • One end of the driving wire 110 is located on the joint body 51 the far end, the other end along the long The degree direction sequentially passes through the corresponding threading channel 520 on the first tube body 111 and is led to the proximal end of the second tube body 112.
  • the adjacent joint portion 510 is configured to be wound between the two under the tension of the driving wire 110. Node 511 produces relative deflection.
  • the joint part 510 may not be annular, for example, may be in the shape of a solid column, and the threading channel 520 may be provided outside the joint part 510 .
  • only part of the threading buckle 52 may be detachably fixed on the limiting part, and the other part of the threading buckle 52 may be non-detachably connected or integrated with the limiting part.
  • the limiting part is a first through hole 513 that penetrates the wall of the joint part 510 .
  • the threading buckle 52 includes a head provided with a threading channel 520 and a tail provided with a blocking part 521 .
  • the size of the threading buckle 52 is determined by It is configured to allow the head of the threading channel 520 to pass out of the first through hole 513 and to limit the blocking portion 521 from passing through the first through hole 513.
  • the size of the head of the threading buckle 52 is smaller than the size of the tail, so that the blocking portion 521 can prevent the tail of the threading buckle 52 from passing through the first through hole 513 along with the head, thereby holding the threading buckle 52 on the inner wall of the first through hole 513 .
  • the threading buckle 52 is wedge-shaped, and the threading channel 520 is opened at a smaller head of the wedge-shaped threading buckle 52 .
  • Figure 18A shows the situation where the driving wire 110 is installed in the first tube body 111.
  • the first through hole 513 is a horn hole with a small inside and a large outside.
  • the threading buckle 52 passes through the first through hole 513 from outside to inside, so that The threading channel 520 of the head is located in the first tube body 111 , and the blocking portion 521 is embedded in the first through hole 513 and clamped with the hole wall.
  • the head shape of the threading buckle 52 includes, but is not limited to, triangle, rectangle, trapezoid, and arc.
  • each section of the joint part 510 may have only two limiting parts, and the limiting parts of the two adjacent sections of the joint part 510 may be staggered in the circumferential direction of the joint body 51; or, one part of the joint part 510 may be provided with There are four limiting parts spaced apart in the circumferential direction. There are no limiting parts on the upper and/or lower joint parts 510 (as shown in Figure 16).
  • two limiting parts are provided on one side of a joint part 510 in the radial direction, and the two limiting parts on the previous joint part 510 and/or the next joint part 510 of the joint part 510 are both provided on correspond The other side of the joint part 510 in the radial direction; for another example, two limiting parts are symmetrically provided at both ends of the joint part 510 in the radial direction, and the previous joint part 510 and/or the next joint of the joint part 510
  • the connection line between the two limiting parts on the joint part 510 and the connection line between the two limiting parts on the joint part 510 intersect with each other, so that only two driving wires 110 are positioned on each section of the joint part 510, and four driving wires 110 are positioned thereon.
  • each set of threading channels 520 is parallel to the axial direction of the first tube body 111 .
  • each group of threading channels 520 may not be parallel to the axial direction of the first tube body 111, but may be in a spiral S shape, that is, every two adjacent driving wires 110 are not parallel, but staggered.
  • a certain spiral angle, and at least one driving wire 110 can even be set to rotate in the opposite direction to the other driving wires to avoid distortion of the catheter during the driving process.
  • two spirals are arranged on different sides in the radial direction.
  • the two driving wires located on the same side in the radial direction rotate in opposite directions (as shown in Figure 18B).
  • the part of the driving wire close to the proximal end of the joint body 51 (or the second tube body 112) can be provided.
  • other parts of the drive wire remain parallel to the axial direction of the tube body where it is located. At least two adjacent drive wires are staggered by a certain helical angle or have opposite directions of rotation and are arranged crosswise.
  • the proximal end of the tube body is less likely to deform and avoid unexpected bending; further, the helical spacing near the distal end on the drive wire can be set smaller than the proximal end.
  • the receiving groove 1132 inside the thickened portion 1131 can also be in a spiral shape matching the arrangement of the threading channel 520 .
  • at least one section of the joint portion 510 may have only one limiting portion, or no limiting portions may be provided on multiple consecutive sections of the joint portion 510 .
  • the threading channel 520 can also be configured as a corresponding arc-shaped channel.
  • adjacent two-level nodes 511 are staggered in the circumferential direction of the joint body 51.
  • the two nodes 511 at the proximal ends of each middle joint body 51 are offset along the first diameter.
  • 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.
  • the offset angle between the first radial direction and the second radial direction may be other angles other than 90°, or may not be offset.
  • the driving wire 110 may not be connected with the node 511 is staggered, that is, the limiting part is provided on the same side of the node 511.
  • the first through hole 513 in FIG. 17 is opened on the side of the connecting beam 511a of the joint part 510 and is located on the extension line of the connecting beam 511a.
  • the first tube body 111 may also include a flexible wrapping layer located on the outer peripheral surface of the joint body 51.
  • the flexible wrapping layer may be a flexible sleeve that is placed on the outer peripheral surface of the joint main body 51 after the threading buckle 52 is installed. It may be a plastic material integrally formed on the outer peripheral surface of the joint body 51 .
  • FIGS 19A to 19H show several installation methods of the thread buckle that are different from Figure 18A.
  • the blocking portion 521 includes two limiting feet 5210 at the tail of the threading buckle 52 .
  • the two limiting feet 5210 are opened 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 feet 5210 is greater than the size of the first through hole 513 in the circumferential direction of the joint portion 510, so that after the threading buckle 52 passes through the first through hole 513, the two limiting feet 5210 abut against the first through hole 513.
  • the edge of a through hole 513 does not enter, and the threading channel 520 of the head of the threading buckle 52 forms a closed ring.
  • the structure of the threading buckle 52 is roughly the same as that of Figure 19A.
  • the main difference is that the threading channel 520 at the head of the threading buckle 52 in this embodiment is not closed, but is connected to two parts of the threading buckle 52 respectively.
  • 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.
  • the structure of the threading buckle 52 is roughly the same as that of Figure 19B.
  • the main difference is that the threading buckle 52 shown in Figure 19B has its head facing inward and is inserted from the outside of the joint part 510.
  • the installed threading buckle 52 has its head at the joint part. 510 inside and the tail outside the joint part 510, relying on the blocking part 521 of the tail to limit the threading buckle 52 from coming out of the first through hole 513; the installation direction of the threading buckle 52 in this embodiment is opposite to that of Figure 19B, the threading buckle 52 has its head facing The outer part is inserted into the joint part 510 .
  • the installed threading buckle 52 has its head outside the joint part 510 and its tail part inside the joint part 510 .
  • the blocking part 521 at the tail restricts the threading buckle 52 from coming out of the first through hole 513 .
  • the shape of the limiting foot 5210 can also be made into an arc shape that matches the wall of the joint portion 510 to further reduce the occupied volume of the joint portion 510 .
  • the first group of threading channels 520 for threading the same driving wire 110 may be located within the wall of the joint part 510 , or may be located outside the wall of the joint part 510 .
  • a part of the driving wires 110 may be arranged outside the wall of the joint part 510
  • another part of the driving wires 110 may be arranged inside the wall of the joint part 510 .
  • a hook portion 5211 can also be provided at the end of the limiting leg 5210.
  • the limiting portion also 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 The insertion direction of the threading buckle 52 is inserted into the accommodating part 513a.
  • the receiving portion 513a may be a groove or a through hole.
  • the threading buckle 52 can be made into an elastic piece 522.
  • the elastic piece 522 can deform under the action of external force and recover its deformation after the external force is removed. It includes wing portions 522a at both ends and a threading portion 522b in the middle.
  • the structure of the elastic piece 522 can be the same as the above-mentioned embodiment shown in FIGS. 19A to 19C, but the usage is slightly different. In order to distinguish it from the above-mentioned embodiment and facilitate description, the labels and names of the corresponding parts are changed here.
  • the wing portion 522a is similar to the limiting foot 5210
  • the threading portion 522b is similar to the arm of the threading buckle 52 connected to the limiting foot 5210.
  • the wing portions 522a at both ends are respectively limited by limiting portions at different locations in the circumferential direction of the joint portion 510 (in the left-right direction in Figure 19E), and the threading portion 522b at least partially encloses the threading channel 520.
  • the limiting part includes a pair of insertion limiting parts 514 provided on the wall of the joint part 510.
  • the wing parts 522a at both ends are respectively inserted into one of the insertion limiting parts 514 and then held by the wall of the joint part 510.
  • the limiting slot 514 is a sandwich slot provided in the wall of the joint part 510 .
  • the two limiting slots 514 are spaced apart in the circumferential direction of the joint part 510 and face each other.
  • the threading buckle 52 When installing the threading buckle 52, first compress the threading part 522b, so that the wing parts 522a at both ends are close to each other, and the wing parts 522a at both ends are respectively aligned with the two limiting slots 514. Release the threading part 522b, and the threading part 522b will resume its deformation. The wing portions 522a at both ends automatically snap into the limiting slots 514 on both sides.
  • the driving wire 110 can be placed before the threading buckle 52 is installed, or can be threaded after the threading buckle 52 is installed. It can be understood that after the external force is removed, the wing portions 522a at both ends can elastically contact the two insertion limiting portions 514, or they can not elastically contact but only be accommodated therein.
  • the limiting slot 514 is a hole penetrating the wall of the joint part 510
  • the installation method of the threading buckle 52 is the same as the embodiment of FIG. 19E .
  • the stopper 514 When the stopper 514 is inserted into a hole, the wing portions 522a at both ends recover their deformation and expand after passing through the corresponding holes in a compressed state, and are limited by the wall on the other side of the joint portion 510; when the stopper 514 is inserted When it is a slot opened in a mezzanine in the wall, the wing portions 522a at both ends are inserted into the corresponding slot in a compressed state and then resume deformation and expand, and are blocked by the side walls of the slot from coming out.
  • the threading portion 522b between the wing portions 522a at both ends can also be made into an arched portion, for example, a semi-circular shape with an arc greater than 180°, so that a V-shape is formed between the threading portion 522b and the wing portions 522a on both sides.
  • the V The wall-shaped structure of the joint portion 510 is clamped therein, and can also prevent the threading buckle 52 from moving radially, especially when the limiting slot 514 is a hole as shown in FIG. 19F.
  • the limiting part includes an interlayer 515 provided on the wall of the joint part 510 .
  • the interlayer 515 includes a main body part 516 and a notch part 517 that divides the main body part 516 into two parts.
  • An interlayer space M is formed between the left and right parts of the main body part 516 and the wall of the joint part 510 respectively, and the two interlayer spaces M face each other along the circumferential direction of the joint part 510 .
  • the two parts of the main part 516 respectively include anti-separation parts 518 extending towards the notch part 517.
  • the wing parts 522a at both ends are inserted into a mezzanine space M respectively. , the wing portion 522a is restricted from coming out by the anti-falling portion 518 .
  • 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 top to bottom as shown in FIG. 19H) via the anti-separation portion 518, and when the threading portion 522b is not inserted When 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 formed by the anti-separation portion 518
  • the gap between the joint part 510 and the wall of the joint part 510 slides into the interlayer space M.
  • the threading part 522b recovers its deformation, and the wing parts 522a on both sides open and are completely limited at the corresponding In the mezzanine space M; alternatively, in some embodiments, the threading portion 522b can also be directly compressed until the distance between the outer sides of the wing portions 522a is less than the inner edge distance of the left and right mezzanine spaces M, and then aligned with the left and right mezzanines.
  • the space M is then inserted under the deformation restoring force.
  • the wall structure of the joint portion 510 in Figure 19H can be used in conjunction with the elastic pieces 522 of Figures 19E to 19G , and the threading channel 520 can also be Formed by a closed ring structure.
  • the threading channel 520 can be installed outside the joint portion 510; the structure of the threading buckle 52 and the limiting portion in the first tube body 111 can include one or more of the above.
  • the first tube body 111 in this embodiment can be of various structural shapes.
  • Figures 16 to 17 show one structure of the first tube body 111
  • Figures 20 to 21C show another structure of the first tube body.
  • Figures 22 to 23C show yet another structure of the first tube body, and
  • Figure 24 shows yet another structure of the first tube body.
  • the node 511 is configured as a connecting beam 511a, and each two adjacent joint portions 510 are fixedly connected by two connecting beams 511a located on different sides in the radial direction.
  • the number of connecting beams 511a can also be appropriately increased, such as 3, 4..., and for example, two connecting beams 511a close to each other can be provided on one side in the radial direction.
  • 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 driven by the driving wire, the distal end of the joint body 51 bends first, which is more compatible with anatomical characteristics.
  • the width of the connecting beam 511a closer to the distal end of the joint body 51 is smaller, showing a linear decreasing trend; or the joint body 51 has multiple curvature changing sections, and the width of the connecting beam 511a in each curvature changing section is the same.
  • the width of the connecting beam 511a in the curvature changing section closer to the distal end of the joint body 51 becomes smaller, showing a stepwise decreasing trend.
  • 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.
  • a linear change or a stepwise change in the length of the connecting beam 511a can also achieve a similar effect. .
  • the connecting beam 511a can be integrally cut with the joint body 51. Both 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 intervals H2 connect the two adjacent joint parts 510. are separated in the axial direction, so that when the connecting beam 511a is driven to bend, the distance between the two adjacent joint portions 510 on both sides of the connecting beam 511a (i.e., the deflection interval H2) changes.
  • the surface of H2 is set as a flared inclined surface, which can bring the two adjacent joint sections 510 closer together under the deflection interval H2 of the same size, where the joint body 51 can achieve greater bending deformation.
  • 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 amount of bending deformation.
  • 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 arc surface 5112a of the female connector 5112 through the first convex arc surface 5111a; the first convex arc surface 5111a and the first concave arc surface 5112a face each other, and the two The first concave arc surfaces 5112a are inclined relative to the rotation center line of the male connector 5111, and are inclined toward the outside of the joint portion 510 or toward the inside of the joint portion 510.
  • 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 disc-shaped edge has a C-shaped first convex arc surface 5111a.
  • the free end of the female connector 5112 has a shape similar to A disc-shaped complementary groove having a first concave arc surface 5112a and a connecting second A notch 5112c on the concave arc surface 5112a.
  • the first convex arc surface 5111a is embedded in the first concave arc surface 5112a and has a clearance fit with it.
  • At least part of the notch 5112c accommodates the non-free end of the male connector 5111 and uses its walls (the upper and lower walls in Figure 21C) to limit the first The angular range within which the convex arc surface 5111a rotates within the first concave arc surface 5112a.
  • first convex arc surface 5111a of each node 511 there are two nodes 511 located on different sides in the radial direction between two adjacent joint portions 510.
  • first convex arc surface 5111a of each node 511 The first concave arc surfaces 5112a are inclined surfaces facing each other, and relative to the rotation center line of the male connector 5111, both first concave arc surfaces 5112a are inclined toward the outside of the joint assembly or both are inclined toward the inside of the joint assembly.
  • first concave arc surface 5112a is a chamfered surface toward the outside of the joint assembly
  • first convex arc surface 5111a is a chamfered surface toward the inside of the joint assembly.
  • the angles of the two are basically complementary.
  • the two first concave arc surfaces 5112a both prevent the matching first convex arc surface 5111a from moving radially inward. There is a clearance fit between the two, allowing relative rotation within a certain angular range.
  • Such a structure can be formed into an integrated structure through laser cutting. For example, as shown in FIG. 21C , the two nodes 511 are arranged rotationally symmetrically about the center of the joint part 510 through laser cutting. Therefore, the male connector 5111 and the female connector 5112 on the two adjacent joint portions 510 formed by cutting are still integrated and not separated.
  • the angular range of the first convex arc surface 5111a located at the distal end of the joint component within the first concave arc surface 5112a is greater than the angle range of the first convex arc surface 5111a located at the proximal end of the joint component within the first concave arc surface 5112a
  • the angle range of internal rotation For example, from the proximal end of the joint component toward the distal end, the angle range in which the first convex arc surface 5111a rotates within the first concave arc surface 5112a gradually increases linearly or stepwise.
  • the female connector 5112 of this embodiment can further include a first C-shaped arm C1, and the first concave arc surface 5112a is provided on the first C-shaped arm On the inner edge of C1, the second convex arc surface 5112b is provided on the outer edge of the first C-shaped arm C1.
  • the node 511 also includes a second concave arc surface 5111b.
  • the second concave arc surface 5111b extends from the male connector 5111. Both sides of the non-free end extend and are concentric with the first convex arc surface 5111a.
  • first convex arc surface 5111a, first concave arc surface 5112a, second concave arc surface 5111b, and second convex arc surface 5112b are concentrically arranged.
  • the arc surface 5112b has a clearance fit with the second concave arc surface 5111b, and the annular tube may be separated by laser cutting.
  • the second convex arc surface 5112b and the second concave arc surface 5111b can also be inclined surfaces facing each other. What is shown in Figure 21B is that the second concave arc surface 5111b is inclined toward the outside of the joint assembly, and the second convex arc surface is inclined toward the outside of the joint assembly. 5112b is inclined toward the inside of the joint assembly.
  • the second concave arc surface 5111b is inclined toward the inside of the joint assembly
  • the second convex arc surface 5112b is inclined toward the outside of the joint assembly
  • two sets of radially opposite groups are provided.
  • the two convex arc surfaces 5112b and the second concave arc surface 5111b can also prevent radial separation.
  • 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 their free ends form a notch 5112c.
  • the upper/lower walls of the non-free end of the male connector 5111 are respectively in contact with the second concave arc surface.
  • 5111b and the first convex arc surface 5111a form two arc-shaped grooves for the first C-shaped arm C1 to be accommodated.
  • 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.
  • the arc-shaped groove serves as a guide part to guide the sliding of the first C-shaped arm C1, and the end surface of the notch 5112c of the first C-shaped arm C1 is in contact with the non-free end of the male connector 5111.
  • the arc groove between the upper and lower walls is used to limit the rotation angle of the male connector 5111 relative to the female connector 5112.
  • the spacing radian also called the arc groove radian
  • the joint tangent angle ⁇ 3 + ⁇ 4 between the two adjacent joint parts 510 on the distal side of the joint body 51 is larger.
  • the upper and lower spacing arcs ⁇ 1 , ⁇ 2 is equal, and ⁇ 3 and ⁇ 4 are equal.
  • ⁇ 1 and ⁇ 2 may not be equal, and ⁇ 3 and ⁇ 4 may not be equal.
  • the above arrangement can allow the distal joint portion 510 to have a larger bending angle.
  • the joint body 51 is divided into multiple sections, between the free end of the first C-shaped arm C1 and the side surface of the male connector 5111 in each section
  • the sum of the spacing radians ⁇ 1 + ⁇ 2 (or the joint tangent angle ⁇ 3 + ⁇ 4 between two adjacent joint parts 510 ) is equal, but the closer to the distal section, the free end of the first C-shaped arm C1 and between the sides of the male connector 5111 The larger the sum of spacing radians ⁇ 1 + ⁇ 2 (or the joint angle ⁇ 3 + ⁇ 4 between two adjacent joint portions 510 ).
  • the free end of the male connector 5111 further includes a second C-shaped arm C2.
  • the second C-shaped arm C2 is provided on the periphery of the first convex arc surface 5111a, and the second concave arc surface 5111b is provided on the inner edge of the second C-shaped arm C2, and the third convex arc surface 5111c is provided on the outer edge of the second C-shaped arm C2.
  • the third convex arc surface 5111c, the second concave arc surface 5111b, and the first convex arc surface 5111a concentric.
  • the second C-shaped arm C2 and the disc-shaped edge form a receiving and rotating space for the first C-shaped arm C1.
  • the node 511 also includes a third concave arc 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 arc surface 5112a, and the third convex arc surface 5112d.
  • the surface 5111c has a clearance fit with the third concave arc surface 5112d.
  • the notch at the end of the second C-shaped arm C2 cooperates with the non-free end of the female connector 5112.
  • the notch matches the non-free end of the female connector 5112 ( That is, the arc groove radian ⁇ ' 1 (or ⁇ ' 2 ) between the non-free end of the first C-shaped arm C1) is smaller than the corresponding gap 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 cooperate with the non-free end of the female connector 5112 to limit the rotation of the third convex arc surface 5111c in the third concave arc surface 5112d.
  • the arc groove radian ⁇ ' 1 (or ⁇ ' 2 ) between the notch and the non-free end of the female connector 5112 is greater than the corresponding notch 5112c of the first C-shaped arm C1 and the male connector 5111
  • the angular range of the first convex arc surface 5111a rotating in the first concave arc 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 arc surface 5112a of the male connector 5111 to achieve a more stable rotation guidance function.
  • the effect of restricting the radial protrusion of the two adjacent joint sections 510 can be further enhanced.
  • the two third concave arc surfaces 5112d can both be inclined toward the outside of the joint assembly, or both can be inclined toward the inside of the joint assembly.
  • the sum of the spacing radians between the free end of the second C-shaped arm C2 and the side surface of the female connector 5112 on the distal side of the joint body 51 is ⁇ ' 1 + ⁇ ' 2 bigger.
  • the specific setting method may be that from the proximal end to the distal end of the joint body 51, the sum of the spacing radians ⁇ ' 1 + ⁇ ' 2 between the free end of the second C-shaped arm C2 and the side surface of the female connector 5112 gradually increases.
  • the joint body 51 is divided into multiple sections, and the sum of the spacing radians between the free end of the second C-shaped arm C2 of each section and the side surface of the female connector 5112 is equal to ⁇ ' 1 + ⁇ ' 2 , But the closer the segment is to the far end, the The greater the sum of the spacing arcs ⁇ ' 1 + ⁇ ' 2 between the free end of the second C-shaped arm C2 and the side surface of the female connector 5112 is.
  • the above embodiment only shows the case where the female connector 5112 has one C-shaped arm and the male connector 5111, and the female connector 5112 has one C-shaped arm respectively.
  • the male connector 5111 The number of C-shaped arms on the female connector 5112 can be increased, just ensure that the corresponding arc surfaces on the male and female connectors are concentric.
  • the joint body in this embodiment is connected by multiple split joint parts 510.
  • the node 511 is configured as a hinge axis, and each two adjacent joint parts 510 pass between them. Two hinge axes arranged radially symmetrically are hinged.
  • the threading buckle 52 is formed as an arched portion recessed in the joint portion 510 .
  • the threading buckle 52 of this structure can be integrally produced on the wall of the joint portion 510 by stamping. In other embodiments, welding or other methods can also be used to fix the threading buckle 52 on the wall of the joint portion 510 .
  • references to the terms “one embodiment,” “some embodiments,” “an example,” “specific examples,” or “some examples” or the like means that specific features are described in connection with the embodiment or example. , structures, materials or features are included in at least one embodiment or example of the invention. In this specification, the schematic expressions of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the specific features, structures, materials or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, those skilled in the art may combine and combine different embodiments or examples and features of different embodiments or examples described in this specification unless they are inconsistent with each other.

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Abstract

本发明提供了一种柔性手术器械、导管及关节组件，关节组件包括关节主体和多个穿线扣，关节主体包括多段关节部、联接相邻的两段所述关节部的节点以及沿长度方向上间隔地设于所述关节主体上的多个限位部，所述穿线扣设于所述限位部上并设有供驱动丝穿过的穿线通道，所述穿线扣可拆卸地固定在所述限位部，相邻的所述关节部被配置为可在所述驱动丝的张力下绕二者之间的节点产生相对偏转。本发明的穿线扣可拆卸地安装在各段关节主体的限位部上，通过将驱动丝穿过穿线扣的穿线通道并张紧，只需调节施加至驱动丝的张紧力即可改变柔性关节组件的弯曲形状，不会明显增加导管的直径，保证了产品的结构紧凑性。

Description

柔性手术器械、导管及关节组件
本申请要求于2022年7月18日提交中国知识产权局，申请号为202210841830.1，发明名称为“柔性手术器械、导管及关节组件”的中国专利申请的优先权。
技术领域
本发明涉及医疗器械技术领域，尤其涉及一种柔性手术器械、导管及关节组件。
背景技术
随着微创手术技术与人工智能技术的发展，机器人辅助微创手术逐渐成为微创外科手术的发展趋势之一。微创手术可以通过患者身体表面的自然孔口或通过一个或多个外科手术切口实施。通过这些自然孔口或切口，医生可以将微创医疗器械，如外科手术器械、诊断器械、治疗器械或活检器械等插入到达患者体内的目标位置。
为了精确引导相应的微创医疗器械到达目标位置，微创手术可以为微创医疗器械配备有内窥镜，内窥镜允许器械在插入、拔出或执行医疗程序的过程中为医生提供显示有组织、器官和/或器械的视野。例如，利用支气管内窥镜进行检查的过程中，内窥镜所在的细长柔性工具可以被插入到患者口中，经过患者喉咙依次进入气管、肺气道、肺部，以允许医生检查患者肺气道例如支气管和细支气管的内部状况，以便医生进行诊断和/或医疗程序。
内窥镜等手术工具通常被配置于不同的细长柔性工具的远端，细长柔性工具被从患者的体外驱动而在体内例如狭小腔道内根据需要发生形变，细长柔性工具的结构设计需要保证产品的结构紧凑性以减少其占空间。
发明内容
鉴于现有技术的不足，本发明提供了一种柔性手术器械、导管及关节组件，可以保证产品的结构紧凑性，以便其根据需要被驱动而在患者体内灵活地发生形变。
为了实现上述的目的，本发明采用了如下的技术方案：
一种关节组件，用于柔性手术器械中，包括：
关节主体，包括多段关节部、联接相邻的两段所述关节部的节点以及沿长度方向上间隔地设于所述关节主体上的多个限位部；
多个穿线扣，所述穿线扣设于所述限位部上并设有供驱动丝穿过的穿线通道，至少一个所述穿线扣可拆卸地固定在所述限位部上；
其中，相邻的所述关节部被配置为可在所述驱动丝的张力下绕二者之间的节点产生相对偏转。
作为其中一种实施方式，所述限位部包括贯穿所述关节部的壁的第一通孔，所述穿线扣包括设有所述穿线通道的头部和设有阻挡部的尾部；
所述穿线扣的尺寸被配置为允许所述头部穿出所述第一通孔外，且限制所述阻挡部穿过所述第一通孔。
作为其中一种实施方式，所述穿线扣呈楔形。
作为其中一种实施方式，所述阻挡部包括所述穿线扣尾部的两个限位脚，两个所述限位脚背向彼此张开而被所述第一通孔的边缘限制进入所述第一通孔。
作为其中一种实施方式，所述穿线扣包括弹片，所述弹片包括两端的翼部和中间的穿线部；
两端的所述翼部分别由所述限位部限位在所述关节部的周向上的不同部位，所述穿线部至少部分围成所述穿线通道。
作为其中一种实施方式，所述限位部包括设于所述关节部的壁上的一对插入限位部，所述一对限位插槽为孔或槽，在所述关节部的周向上设置；
两端的所述翼部分别插入一个所述插入限位部内后由所述关节部的壁卡持。
作为其中一种实施方式，所述限位部包括设于所述关节部的壁上的夹层，所述夹层包括主体部和将所述主体部分隔成两部分的豁口部；
所述主体部的两部分分别与所述关节部的壁之间形成一个夹层空间，两个所述夹层空间沿所述关节部的周向上朝向彼此；
所述主体部的两部分分别包括朝向所述豁口部延伸的防脱部；所述弹片被配置为所述穿线部被压缩后，两端的所述翼部分别插入一个所述夹层空间内，并由所述防脱部限制从所述夹层空间脱出。
作为其中一种实施方式，用于穿设其中一根所述驱动丝的第一组穿线通道都位于所述关节部的壁内，和/或，用于穿设其中一根所述驱动丝的第二组穿线通道都位于所述关节部的壁外。
作为其中一种实施方式，所述节点包括连接梁，每两段相邻的所述关节部之间通过至少两根位于其径向上不同侧的所述连接梁固定连接；
所述关节主体近端的连接梁的宽度大于所述关节主体远端的连接梁的宽度，和/或，所述关节主体近端的连接梁的长度小于所述关节主体远端的连接梁的长度。
本发明的另一目的在于提供一种导管，包括驱动丝、柔性的第二管体和一种上述的关节组件，所述关节组件连接在所述第二管体的远端，所述驱动丝的一端设于所述关节组件的远端，另一端沿长度方向依次穿过所述关节组件上对应的穿线通道后引出至所述第二管体的近端。
作为其中一种实施方式，所述导管还包括连接所述关节组件和所述第二管体的连接环，所述连接环的远端外壁凸设有多个加厚部，所述关节组件的近端开设有被配置为供所述加厚部插设的安装插槽。
作为其中一种实施方式，所述导管还包括套设于所述驱动丝外并可在轴向上被压缩的弹性管，所述加厚部的内表面设有轴向延伸的容纳槽，所述弹性管和/或所述驱动丝至少部分容纳于所述容纳槽内。
本发明的又一目的在于提供一种柔性手术器械，包括外鞘和一种上述的导管，所述导管被配置为可拆卸地插入和拔出所述外鞘。
本发明的穿线扣可拆卸地安装在各段关节主体的限位部上，通过将驱动丝穿过穿线扣的穿线通道并张紧，只需调节施加至驱动丝的张紧力即可改变柔性关节组件的弯曲形状，不会明显增加导管的直径，保证了产品的结构紧凑性。
附图说明
为了更清楚地说明本发明实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本发明的某些实施例，因此不应被看作是对范围的限定，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他相关的附图。
图1为本发明实施例的一种柔性手术器械的结构示意图；
图2为本发明实施例的一种非弯曲状态下的导管的简化结构示意图；
图3为本发明实施例的一种弯曲状态下的柔性手术器械的简化结构示意图；
图4为本发明实施例的一种先端部的结构示意图；
图5A为本发明实施例的一种导管局部的结构分解示意图；
图5B为本发明实施例的一种导管的局部结构示意图；
图6示出了本发明实施例的一种外鞘的内部结构示意图；
图7A为本发明实施例的一种导管的对位方式示意图；
图7B示出了本发明实施例的另一种导管的对位方式示意图；
图7C示出了本发明实施例的又一种导管的对位方式示意图；
图8A示出了本发明实施例的一种导管内部的结构示意图；
图8B示出了本发明实施例的一种连接环与第一管体的配合方式示意图；
图8C示出了本发明实施例的一种连接环与第二管体的配合方式示意图；
图9示出了本发明实施例的一种内置器械的导管的远端结构示意图；
图10示出了图9的结构分解示意图；
图11示出了本发明实施例的另一种内置器械的导管的远端结构示意图；
图12示出了本发明实施例的又一种内置器械的导管的远端结构示意图；
图13示出了本发明实施例的再一种内置器械的导管的远端结构示意图；
图14为本发明实施例的一种图像采集组件的结构示意图；
图15为本发明实施例的一种先端部的结构透视示意图；
图16示出了本发明实施例的第一种第一管体的结构示意图；
图17为图16中A处的放大图；
图18A示出了图16的穿线扣的安装方式示意图；
图18B示出了一种第一管体内的驱动丝的穿线方式示意图；
图19A～19H示出了本发明实施例的几种不同的穿线扣的安装方式示意图；
图20示出了本发明实施例的第二种第一管体的结构示意图；
图21A示出了图20所示的第一管体的主视图；
图21B为图21A中B处的放大图；
图21C为图21B的一个剖视示意图；
图22示出了本发明实施例的第二种第一管体的结构示意图；
图23A示出了图22所示的第二管体的主视图；
图23B为图23A中C处的放大图；
图23C为图23B的一个剖视示意图；
图24示出了本发明实施例的第三种第一管体的结构示意图；
元件符号说明：
10-导管；10H-工作通道；11-导管主体；11V-第二对位部；110-驱动丝；
110a-弹性管；111-第一管体；112-第二管体；1110-驱动丝限位部；12-通道管；13-图像采集组件；13a-图像模组；13b-光源；14-先端部；14V-第一对位部；141-第二通孔；142-第一通孔；143-连接环；144-翻边；145-凹部；15-定位传感器；20-外鞘；21-插入通道；30-内部器械；321-流体通道；L-信号线；51-关节主体；510-关节部；511-节点；511a-连接梁；513-第一通孔；514-限位部；515-夹层；516-主体部；517-豁口部；518-防脱部；5111- 公连接头；5111a-第一凸弧面；5111b-第二凹弧面；5111c-第三凸弧面；5112-母连接头；5112a-第一凹弧面；5112b-第二凸弧面；5112c-缺口；5112d-第三凹弧面；52-穿线扣；520-穿线通道；521-阻挡部；522-弹片；522a-翼部；522b-穿线部；5210-限位脚；C1-第一C形臂；C2-第二C形臂；M-夹层空间；S-坡面。
具体实施方式
为了使本发明所要解决的技术问题、技术方案及有益效果更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
需要说明的是，当元件被称为“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”，“水平的”，“左”，“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。本文所使用的术语“远端”，“近端”作为方位词，该方位词为介入医疗器械领域惯用术语，其中“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。
需要理解的是，术语“长度”、“宽度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所 使用的术语只是为了描述具体的实施方式的目的，不是旨在限制本发明。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
以下将结合附图进行详细描述。
参阅图1，本发明实施例提供了一种柔性手术器械，该柔性手术器械主要包括导管10和外鞘20，外鞘20内部提供有插入通道21，插入通道21具有比导管10稍大的直径，外鞘20可以沿着预定的管腔路径插入到患者体内，导管10被配置为沿着该插入通道21可拆卸地插入和拔出外鞘20，从而进入体内预定的位置或从预定的位置退出。
示例性地，导管10和外鞘20均呈细长管状构造，主体部分采用柔性材料制成，为了精确地控制细长管在人体管腔(例如，气道、气管、胃管等管道或体腔)内的行进过程，导管10、外鞘20都可以采用沿其长度方向布置的驱动丝来控制其远端的自由度，从而改变细长管的形状、刚度和远端的取向，这样的驱动方式使得操作者能够在位于体外的细长管近端控制细长管远端的动作。例如，细长管的其中一个径向上相对布置的两根驱动丝可以提供某一方向(如俯仰)上的自由度，细长管的两个不同的径向上相对布置的四根驱动丝可以提供更多方向(如俯仰、偏航及转向)的自由度，而导管10与外鞘20上彼此的驱动丝的配合则可以为导管10提供更多的自由度。可以理解的是，驱动丝的数量不限于此，可以根据需要进行调整。
图2示出了非弯曲状态下的导管的简化结构示意图，图3示出了弯曲状态下的柔性手术器械的简化结构示意图。结合图1～3，本实施例提供了一种柔性手术器械的导管10，该导管10包括导管主体11、通道管12、图像采集组件13以及先端部14，导管主体11作为导管10的主要部分，结合图4和图5，通道管12设于导管主体11内，图像采集组件13包括图像器件及其信号线L，信号线L设于通道管12与导管主体11之间的间隙内，图像器件则容纳并固定在先端部14内。在一个实施例中，先端部14连接于导管主体11的远端，具有第一通孔142和第二通孔141，图像器件收容于第二通孔141内，先端部14的近端凸设有连接环143，该连接环143沿第一通孔142的边缘朝向通道管12凸设，通道管12套设于连接环143外表面而与第一通孔142连通，形成工作通道(如图3虚线所示)。例如，连 接环143可以具有与第一通孔142共面的内壁，从而形成光滑的器械工作通道。由于图像器件集成在先端部14内，信号线L在通道管12与导管主体11之间的间隙内走线，使得导管10内既具有器械的工作通道，又具有内窥镜的功能，可以与外鞘20配合以引导外鞘20在人体内的运动，也可以提供内部器械进出的工作通道和运动载体，当内部器械伸出工作通道外时也能提供内部器械的运动视野，从而利用小型的细长管结构实现了多种功能，提高了结构的紧凑性，降低了手术过程对于空间的要求。与单纯利用通道管12端面或外壁与第一通孔142粘合的方式相比，通道管12采用套设于连接环143外表面与第一通孔142连通的方式可以具有更牢固的连接性能，在导管10弯曲的过程中，通道管12不容易与先端部14剥离，避免了人体的血液、粘液等流体从剥离处进入，也可以实现更好的防水效果。
如图4和5所示，本实施例示出的图像器件包括图像模组13a和两个光源13b，两个光源13b分别设于图像模组13a的两侧，用于为图像模组13a所处的环境提供补光，图像模组13a和光源13b同时嵌设于先端部14内，且位于不同的第二通孔141内，例如，第二通孔141包括一个模组孔141a和位于模组孔141a两侧的光源孔141b，图像模组13a和两个光源13b分别自先端部14的近端插入对应的通孔内，通过过盈配合实现固定，和/或采用粘结剂粘合在先端部14内。第一通孔142的直径大于第二通孔141，第二通孔141间隔地设于第一通孔142的外围，以合理地利用产品空间。通过将图像模组13a和两个光源13b完全埋入先端部14内，可以在一定程度上对图像器件进行保护。
在其他实施方式中，光源13b的数量可以适当增减，其位置也不限于此，例如，各光源13b可以位于图像模组13a的同一侧。图像模组13a和两个光源13b的至少一个也可以仅远端部分埋入先端部14内，近端部分位于导管主体11与通道管12之间的间隙内。
示例性地，如图4、图6和图7A，先端部14除了具有连接环143外，还包括同时将连接环143、第二通孔141和第一通孔142包围于其中的一圈翻边144，则连接环143与翻边144、先端部14的近端表面这三者围成环状空间，导管主体11的远端安装于连接环143与翻边144之间。翻边144可以是一圈环边，也可以是在周向上间隔开的多段环边。例如，导管主体11远端的外周面可与翻边144的内壁过盈配合，二者还可通过粘结剂粘结 加固；又例如，导管主体11在靠近远端的外周面直径略小而形成台阶部，导管主体11插入翻边144内并利用该台阶部抵接在翻边144端面而限制导管主体11的进一步插入。在一种实施方式中，导管主体11的远端端面不接触位于连接环143与翻边144之间的先端部14的近端表面，而是保留一定的间隔。通道管12的远端可与连接环143采用过盈配合，例如，通道管12的远端可被胀大后套在连接环143的外周面，二者还可通过粘结剂粘结加固。
示例性地，导管10还包括定位传感器15，用于定位导管10远端的位置，定位传感器15至少部分固定在先端部14上，例如，定位传感器15可以包括EM(Electro Magnetic，电磁)传感器，患者所处的环境中布置有检测磁场，该检测磁场可以由布置在患者一侧的磁场发生器产生，柔性手术器械和医疗设备作为医疗设备的组成部分，当EM传感器的位置和角度不同时，EM传感器的线圈中产生的电流不同，以此来定位导管10远端的位置和取向，在其他实施方式中，定位传感器也可以采用其他传感模块代替，例如光线传感器、超声探头、陀螺仪等。在实际应用中，可以借助EM传感器获取导管10远端的取向，以此来校准图像采集组件13的视野方向。例如图4和图6中，先端部14包括至少贯穿其近端表面的两个凹部145，定位传感器15的远端插设于凹部145内。由于导管10上集成有定位传感器15，当需要将外鞘20插入体内时，可以将导管10与外鞘20同时插入，借助定位传感器15为外鞘20提供运动导航，导管10上的图像器件也能为其提供视野。
这里，凹部145为不贯穿先端部14远端的槽，定位传感器15被先端部14保护于其中，可以避免液体与其接触，定位传感器15的导线则类似图像器件的信号线L，从通道管12与导管主体11之间的间隙引出至近端，以将定位传感器15检测到的位置信号传递出。在有的实施方式中，凹部145也可以是贯穿先端部14远端的通孔，可以从先端部14远端看到定位传感器15。
图中示出的是导管10包括两个EM传感器的情形，这两个EM传感器的轴向交叉设置，彼此呈一定的夹角，两个EM传感器的远端背向彼此延伸，每一个EM传感器可以检测各自所在点的运动情况，两个EM传感器组合则可以检测出导管10远端的偏转情况。两个定位传感器15可以分别 位于图像模组13a的两不同侧，每个凹部145位于模组孔141a和一个光源孔141b之间。可以理解的是，在其他实施方式中，定位传感器15也可以是一个，或者多于两个，定位传感器15与光源13b的相对位置也可以调整。
如图5A，示例性地，先端部14的远端面包括朝外周面倾斜的坡面S。该坡面S可以避免先端部14的远端划伤组织，也可以引导导管10插入外鞘20或者体内。图中示出的是先端部14的单侧切除部分材料后形成单侧坡面S的情形，坡面S与第一通孔142相交，图像器件、两个EM传感器位于先端部14的远端不具有坡面S的同一侧(如图5所示的上方)，两个EM传感器的导线与信号线L位于通道管12的同一侧(如图5所示的上方)。可以理解的是，在其他实施方式中，坡面S可以省略，也可以不止一个，但需要预留出图像模组13a的安装区域。
如图6，外鞘20包括管体22和外鞘驱动丝23，插入通道21贯穿管体22的轴向，管体22的壁上开设有中空通道220，外鞘驱动丝23穿设于中空通道220内，其远端固定在管体22的远端，近端从中空通道220内引出至连接丝驱动机构。具体可以在管体22的远端安装有固定环24，例如，固定环24通过内嵌的方式固定在管体22的壁内，外鞘驱动丝23的远端固定在固定环24上，利用固定环24分散外鞘驱动丝23作用在管体22的壁上的应力。沿管体22的长度方向上，管体22可以包括远端的主动弯曲段和近端的被动弯曲段，主动弯曲段具有比被动弯曲段更低的刚性，以保证外鞘驱动丝23作用时，被动弯曲段不会或基本不会随之发生弯曲。
管体22可以为多层复合结构，外鞘驱动丝23穿设于内层和外层之间的中间层的中空通道220内，中空通道220的内壁可以是具有润滑作用的PTFE(Poly tetra fluoroethylene，即聚四氟乙烯)材料，满足驱动丝运动的润滑需求。管体22内可以设有4根外鞘驱动丝23，用以驱动外鞘的俯仰和偏航，4个中空通道220在周向上间隔地设于管体22内。可以理解的是，在其他实施方式中，外鞘驱动丝23的数量也可以改变，管体22也可以是单层结构。
如图5A、5B、7A，先端部14还可以包括第一对位部14V，与之相应地，导管主体11包括第二对位部11V，当先端部14组装到导管主体11远端时，需要将第二对位部11V对准并与第一对位部14V彼此嵌合，从而保 证图像器件的安装方位正确，而且安装好后，图像器件也不会相对导管主体11旋转错位。
图7A～7C分别示出了三种不同的导管的对位方式示意图。其中，图7A中，第一对位部14V为开设于翻边144的缺口槽，第二对位部11V为自导管主体11远端径向凸设的第一凸部，当先端部14组装到导管主体11远端时，第一凸部卡入缺口槽内。图7B中，第一对位部14V为设于翻边144的内壁的条状凸部，第二对位部11V为开设于导管主体11远端端面的凹槽，当先端部14组装到导管主体11远端时，条状凸部卡入凹槽内。图7C中，第一对位部14V为开设于连接环143与翻边144之间的先端部14的近端表面的插槽，第二对位部11V为自导管主体11远端轴向伸出的第二凸部，当先端部14组装到导管主体11远端时，第二凸部插入插槽内。可以理解的是，上述第一凸部、第二凸部可以是凸块、凸柱等构造，第一对位部14V、第二对位部11V可以包括上述的一种或多种的组合，第一对位部14V、第二对位部11V的数量可以不止一个，例如，多个第一对位部14V/第二对位部11V在周向上间隔设置。
如图1、图2和图8A，本实施例的导管主体11包括柔性的第一管体111和被配置为驱动第一管体111改变曲率的驱动丝110，第一管体111包括驱动丝限位部1110，驱动丝限位部1110靠近第一管体111的远端且与第一管体111的远端端面间隔，驱动丝110沿导管主体11的长度方向延伸且远端被限制在驱动丝限位部1110的朝向先端部14的一侧，例如，驱动丝110的远端通过卡点或者膨大端阻止其朝近端脱出驱动丝限位部1110。驱动丝限位部1110不做在导管主体11远端端面而是与远端端面具有一段距离，可以避免驱动丝110的远端与先端部14近端的结构发生干涉，从而在一定程度上保护定位传感器、图像采集组件13等结构。
导管主体11可以采用单层材料制作，也可以采用多层复合材料制作。沿导管主体11的长度方向上划分，导管主体11可以分为远端的的第一管体111和近端的第二管体112，第一管体111具有比第二管体112更大的弯曲曲率，导管主体11的内表面可以设有穿线部1100，驱动丝110远端由驱动丝限位部1110限位，其近端穿过对应的穿线部1100后从导管主体11的近端引出至张紧机构，从而在张紧机构的作用下改变导管主体11的构型。第一管体111作为主动弯曲部，在驱动丝110的驱动下改变曲率，第二管体 112作为被动弯曲部，在第一管体111的带动下发生变形。在其他实施方式中，穿线部1100可以位于导管主体11的外表面或贯穿导管壁。
示例性地，驱动丝110的外表面还套设有可在轴向上被压缩的弹性管110a(如图1)，弹性管110a始终处于弹性压缩状态，当作用于驱动丝110的张紧力撤去后，弹性管110a恢复形变，使得导管主体11恢复至初始形态，提高了导管10的灵活性。弹性管110a可以是例如弹簧管、塑性管等。进一步地，弹性管110a可以不必贯穿整个导管主体11的长度方向，例如，仅在第二管体112内设置，使得弹性管110a的两端分别与第二管体112的两端相对固定，此种方式可以使得同样直径的第一管体111内可以有更多的设计空间，第一管体111可以做得更细。如图1中，导管主体11包括衔接第一管体111和第二管体112的连接环113，弹性管110a的远端通过焊接或紧固件固定或抵接等方式固定在连接环113上，第一管体111、第二管体112分别套接在连接环113的两端。
如图8B、8C，示出了一种弹性管110a在导管主体11内的安装方式，连接环113的远端外壁凸设有4个加厚部1131，加厚部1131的厚度大于导管主体11其他区域的壁厚，形成凸块，4个加厚部1131间隔地设置在连接环113的外周面。第一管体111的近端开设有与加厚部1131的位置和数量一致的安装插槽111C，安装插槽111C被构造为贯穿第一管体111的端部和壁的缺口，连接环113的两端分别插设于第一管体111、第二管体112内，连接环113的加厚部1131插设于第一管体111上对应的安装插槽111C内，弹性管110a的远端固定在加厚部1131的内壁。
如图8C，每个加厚部1131的内表面还设有轴向延伸的容纳槽1132，即容纳槽1132从连接环113的内壁凹陷至加厚部1131内，当连接环113装入第一管体111内后，与第一管体111的内壁相比，容纳槽1132可以做得更靠近第一管体111的外壁，弹性管110a、驱动丝110可以至少部分容纳于容纳槽1132，这样，弹性管110a的安装部位、驱动丝110可以更少地占用第一管体111的内部空间，驱动丝110可以更加贴近第一管体111，使得导管主体11的结构更加紧凑，可以为其他零部件如导线、通道管12等预留更多的设计空间。可以理解的是，加厚部1131的数量也可以根据驱动丝110的数量进行调整。
如图9所示，柔性手术器械还包括内部器械30，内部器械30可拆卸地插入和拔出通道管12所在的工作通道10H。内部器械30包括但不限于各种手术器械，例如，可以是烧灼器械、夹持器械、切割器械、缝合器械、电钩、冲洗器械等。图9示出的内部器械30是冲洗器械，内部器械30的轴向开设有供流体通过的流体通道321，通过将内部器械30顺着导管10的工作通道10H插入，可以对靶点位置进行冲洗。
示例性地，可以将定位传感器制作在内部器械30的远端端面，利用定位传感器为内部器械30提供导航，例如，在冲洗的过程中实时提供导航。如图10，内部器械30包括细长管体32和第一定位传感器33，内部器械30被配置为可拆卸地插入工作通道10H内，细长管体32内设有贯穿其长度方向的流体通道321，第一定位传感器33固定在细长管体32的远端且与流体通道321相邻设置，通过该流体通道321，可以实现冲洗液等流体的注入和抽出。第一定位传感器33可以与定位传感器15相同，包括但不限于EM传感器、光线传感器、超声探头、陀螺仪。工作通道10H、细长管体32的轮廓匹配，二者间隙配合。
示例性地，内部器械30具有至少两个第一定位传感器33，两个第一定位传感器33响应于磁场发生器发出的磁场而生成不同的输出信号，根据任何一个第一定位传感器33的输出信号可以得知第一定位传感器33所在部位的位置，通过比较两个第一定位传感器33的输出信号，可以确定两个第一定位传感器33的相对位置，从而确定内部器械30的取向，实现内部器械30的位置和取向的检测，为调整内部器械30的方向提供依据。
示例性地，细长管体32内设有贯穿其长度方向的安装通道322和贯穿其长度方向且朝向安装通道322拱起的弧形的隔板323，第一定位传感器33固定在安装通道322内，且安装通道322与流体通道321由隔板323分隔开，第一定位传感器33的信号线可以从安装通道322内引出至近端。第一定位传感器33的体积较小，因此，流体通道321的截面积往往大于安装通道322，以便保证流体的流量。隔板323呈弧形薄壁，使得流体通道321和安装通道322彼此隔离，一方面可以避免流体进入第一定位传感器33所在的通道导致短路，另一方面，拱起状的弧形的隔板323包围安装通道322，也即流体通道321将第一定位传感器33的安装通道322包围于其中，使得 流体通道321至少部分绕第一定位传感器33设置，从而使得流体通道321的截面积尽可能大。
可选地，可以将流体通道321的至少部分内壁，如流体通道321上不与第一定位传感器33相邻的至少一个内壁(如图10所示，流体通道321的上方的壁)设计为与内部器械30轮廓匹配的薄壁，例如，做成与细长管体32的外壁匹配的弧形，流体通道321的弧形壁更薄，弧形壁围成的流体通道321的截面更大，从而保证通道的流量。
在其他实施方式中，流体通道321也可以不绕第一定位传感器33设置，而是只与第一定位传感器33相邻设置，隔板323也可以呈平板状或背向安装通道322拱起。
示例性地，内部器械30可以具有防旋转特征，这里的防旋转特征包括内部器械30的非圆形轮廓，即，工作通道10H的截面为非圆形，使得细长管体32与工作通道10H间隙配合时，细长管体32在工作通道10H内不可转动。也即内部器械30的截面在至少两个不同方向上具有不同的尺寸，第一通孔142的截面在至少两个不同方向上具有不同的尺寸。例如，内部器械30的截面轮廓可以是椭圆形、月牙形、“D”形、扇形(即“V”形)、方形中的一个或至少两个的组合，工作通道10H的截面形状与第一通孔142的截面形状匹配。例如，该防旋转特征也可以是使相对的两侧具有不同的形状，例如上表面为弧形，下表面为方形。图10示出了内部器械30、工作通道10H的截面轮廓是“D”形的情形，图像模组13a和两个光源13b分别位于工作通道10H的上方和左右两侧，工作通道10H靠近图像模组13a、两个光源13b的表面为平面，图像模组13a靠近第一定位传感器33，其他表面大致呈弧面；图11示出了工作通道10H呈腰圆形的情形，工作通道10H的上下表面呈弧面、左右表面呈平面，第一定位传感器33位于下方而远离图像模组13a；图12示出了工作通道10H呈椭圆形的情形，工作通道10H横向布置在图像模组13a和两个光源13b的下方。
在其他实施方式中，防旋转特征也可以包括内部器械30外周面上设置的凸起部(或凹陷部)，与之相应地，工作通道10H的内壁上设置有凹陷部(或凸起部)，当内部器械30插入到工作通道10H内后，二者通过凸起部与凹陷部的配合限制内部器械30转动。例如，如图13，内部器械30外周面上的凸起部324贯穿内部器械30的长度方向，形成凸条，第一定位传 感器33、安装通道322至少部分位于(即，在径向上完全位于或者部分位于)该凸条内，工作通道10H的内壁上对应地设置有贯穿其长度方向的凹陷部10h，该凸起部324与凹陷部10h匹配，可以用来引导内部器械30的插入过程，也可以用来限制二者发生相对转动，还可以将第一定位传感器33部分或完全凸出工作通道10H外，在一定程度上增大工作通道10H的空间。在其他实施方式中，第一定位传感器33也可以不做在该凸条内，或者，内部器械30外周面上的凸起部324不贯穿内部器械30的长度方向，仅为一段或多段凸块，或者一个或多个凸点。
该防旋转特征可以避免第一定位传感器33发生旋转或者装反，实现精确的导航。可以理解的是，可以仅在内部器械30上形成第一定位传感器33，也可以在导管10、内部器械30上同时设有定位传感器，两个结构上的定位传感器分别实现各自所在的导管10、内部器械30的位置检测，共同配合可以确定两个定位传感器的相对位置，实现柔性手术器械的导管10、内部器械30在不同位置状态的导航。在有的实施方式中，柔性手术器械也可以不包括外鞘20。
如图14和图15，示出了一种图像采集组件的结构及其安装方式，图像采集组件包括柔性线路板13c，图像模组13a和光源13b同时设于柔性线路板13c上，信号线L连接柔性线路板13c，从而实现图像采集组件的集成化设计。例如，柔性线路板13c可以具有基部13d和两个分支13e，每个分支的末端的触点分别贴有一个光源13b，图像模组13a贴附于基部13d上位于两个分支13e之间的另一个触点上，先端部14的近端还开设有供基部13d嵌设的凹陷部141c，凹陷部141c同时与用于容纳图像模组13a和光源13b的模组孔141a、光源孔141b连通，基部13d可以嵌入凹陷部141c内，信号线L与基部13d上对应的端子连通，基部13d还可以作为固定在凹陷部141c内的基座。
如图16和图17，示出了一种第一管体111，第一管体111作为一种柔性关节组件，主要包括关节主体51和多个穿线扣52，关节主体51包括多段环状的关节部510、联接相邻的两段关节部510的节点511以及沿长度方向上间隔地设于关节主体51上的多个限位部。其中的每个穿线扣52上均设有供驱动丝110穿过的穿线通道520，每个穿线扣52可拆卸地固定在一个不同的限位部，驱动丝110的一端设于关节主体51的远端，另一端沿长 度方向依次穿过第一管体111上对应的穿线通道520后引出至第二管体112的近端，相邻的关节部510被配置为可在驱动丝110的张力下绕二者之间的节点511产生相对偏转。
在有的实施方式中，关节部510也可以不是环形，例如，呈实心的柱状，穿线通道520设于关节部510外。在有的实施方式中，也可以仅部分穿线扣52可拆卸地固定在限位部，另一部分穿线扣52与限位部不可拆卸地连接或一体设置。
结合图18A所示，限位部为贯穿关节部510的壁的第一通孔513，穿线扣52包括设有穿线通道520的头部和设有阻挡部521的尾部，穿线扣52的尺寸被配置为允许穿线通道520所在的头部穿出第一通孔513外，且限制阻挡部521穿过第一通孔513，也即，穿线扣52头部的尺寸小于尾部的尺寸，使得阻挡部521可以阻止穿线扣52的尾部随头部穿过第一通孔513，从而将穿线扣52卡持在第一通孔513的内壁。
示例性地，穿线扣52呈楔形，穿线通道520开设于该楔形的穿线扣52的尺寸更小的头部。图18A示出的是驱动丝110设于第一管体111内的情形，第一通孔513为内小外大的喇叭孔，穿线扣52从外至内穿过第一通孔513，使其头部的穿线通道520位于第一管体111内，阻挡部521嵌设于第一通孔513内并与孔壁卡持。
可以理解的是，穿线扣52的头部形状包括但不限于三角形、矩形、梯形、弧形。
当装入穿线扣52后，即可将驱动丝110穿过穿线通道520，从而将第一管体111长度方向上对应的穿线扣52串起来。示例性地，可以在每段关节部510上设置四个在周向上隔开的限位部。或者，也可以在每段关节部510仅具有两个限位部，相邻的两段关节部510的限位部在关节主体51的周向上错开；又或者，在其中一段关节部510上设置四个在周向上隔开的限位部，在其上一段和/或下一段关节部510上不设置限位部(如图16)，通过在关节主体51轴向上的关节部510上交替开设限位部，这样可以减少材料上开孔的数量，提高关节的强度，还不会影响驱动丝110的布置。例如，两个限位部都设置在一个关节部510上的径向上的一侧，该关节部510的上一个关节部510和/或下一个关节部510上的两个限位部都设置在对应 关节部510上的径向上的另一侧；又例如，两个限位部对称地设置在关节部510的径向的两端，该关节部510的上一个关节部510和/或下一个关节部510上的两个限位部的连线与该关节部510上两个限位部的连线相互交叉，使得每段关节部510上仅限位两根驱动丝110，四根驱动丝110分别穿设于周向上间隔的四组穿线通道520内，每组穿线通道520与第一管体111的轴向平行。在有的实施方式中，也可以每组穿线通道520不与第一管体111的轴向平行，而是呈螺旋的S形，即每两根相邻的驱动丝110不平行，而是错开一定的螺旋角度，甚至还可以将至少一根驱动丝110设置为与其他驱动丝旋向相反，以避免导管在被驱动过程中发生扭曲畸变，例如，径向上的不同侧各布置有两根螺旋延伸的驱动丝110，位于径向上同一侧的两根驱动丝旋向相反(如图18B)。为了使得关节主体51(或第二管体112，或外鞘20)的近端具有更大的弯曲刚度，可以将驱动丝的靠近关节主体51(或第二管体112)近端的部分设置为不平行于其所在的管体的轴向，驱动丝的其他部分仍保持与其所在的管体的轴向平行，至少两根相邻的驱动丝错开一定的螺旋角度或者旋向相反而交叉设置，管体的近端更不易变形，避免非预期弯曲；更进一步地，还可以将驱动丝上靠近远端的螺旋间距设置得比近端更小。当穿设同一根驱动丝110的穿线通道520成螺旋的S形布置时，加厚部1131内侧的容纳槽1132则也可呈与穿线通道520布置方式匹配的螺旋状。在其他实施方式中，还可以在至少一段关节部510仅具有一个限位部，或者在连续多段关节部510上不设置任何限位部。为了适应S形布置的驱动丝110的活动，穿线通道520也可以设置为相应的弧形通道。
示例性地，沿第一管体111长度方向上，相邻的两级节点511在关节主体51的周向上错开，例如，各中间的关节主体51的近端的两个节点511沿第一径向对称设置，该关节主体51的远端的两个节点511沿与第一径向垂直的第二径向对称设置。在其他实施方式中，第一径向与第二径向的错开角度也可以是非90°的其他角度，或者不错开。图16中，从关节主体51的端面看，四根驱动丝110、四个节点511在其周向上均匀间隔地布置，将关节主体51的周向分成均匀的8等份。四根驱动丝110两两成对设置，分别驱动相邻的两段关节部510相对偏转，其节点511在张紧力下发生弯曲形变。可以理解的是，在其他实施方式中，驱动丝110也可以不与节点 511错开，即，限位部设置在节点511的同侧，例如，将图17中的第一通孔513开设在关节部510的连接梁511a所在侧，位于连接梁511a的延长线上。
除此之外，第一管体111还可以包括位于关节主体51外周面的柔性包裹层，该柔性包裹层可以是在穿线扣52装入后套设于关节主体51外周面的柔性套，也可以是一体形成于关节主体51外周面的塑性材料。
图19A～19H示出了几种不同于图18A的穿线扣的安装方式。
如图19A，阻挡部521包括穿线扣52尾部的两个限位脚5210，两个限位脚5210背向彼此张开而被第一通孔513的边缘限制进入第一通孔513。两个限位脚5210自由端之间的距离大于第一通孔513在关节部510周向上的尺寸，使得穿线扣52穿过第一通孔513后，两个限位脚5210抵接在第一通孔513的边缘而不进入，穿线扣52头部的穿线通道520围成封闭的环形。
如图19B，穿线扣52的结构与图19A的大致相同，主要区别在于本实施例的穿线扣52头部的穿线通道520并不封闭，而是由穿线扣52的两条分别连接至两个限位脚5210的臂围成的V形空间，当穿线扣52装入后，驱动丝110穿设于该V形空间内，位于穿线扣52与关节主体51的壁之间。
如图19C，穿线扣52的结构与图19B的大致相同，主要区别在于图19B所示的穿线扣52是头部朝内从关节部510外装入，安装后的穿线扣52头部在关节部510内侧、尾部在关节部510外侧，依靠尾部的阻挡部521限制穿线扣52脱出第一通孔513；本实施例的穿线扣52的装入方向与图19B相反，穿线扣52是头部朝外从关节部510内装入，安装后的穿线扣52头部在关节部510外侧、尾部在关节部510内侧，依靠尾部的阻挡部521限制穿线扣52脱出第一通孔513。示例性地，限位脚5210的形状还可以做成与关节部510的壁匹配的弧形，进一步减少关节部510的占用体积。
与之对应地，用于穿设同一根驱动丝110的第一组穿线通道520可以都位于关节部510的壁内，也可以都位于关节部510的壁外。例如，可以一部分数量的驱动丝110布置在关节部510的壁外，另一部分数量的驱动丝110布置在关节部510的壁内。
如图19D，还可以在限位脚5210的末端设有钩部5211，限位部还包括设于关节部510的壁上且与第一通孔513相邻的容纳部513a，钩部5211自穿线扣52的装入方向插入容纳部513a内。该容纳部513a可以是凹槽，可以是通孔。
如图19E～19H，穿线扣52可以做成弹片522，弹片522可在外力作用下发生形变并在外力撤去后恢复形变，其包括两端的翼部522a和中间的穿线部522b。弹片522的构造可与上述图19A～19C所示实施例相同，但用法稍有差异，为了区别于上述实施例而便于描述，这里将对应部位的标号和名称进行改变。其中，翼部522a类似于限位脚5210，穿线部522b类似于穿线扣52上连接限位脚5210的臂。
如图19E，两端的翼部522a分别由限位部限位在关节部510的周向上(如图19E中的左右方向)的不同部位，穿线部522b至少部分围成穿线通道520。限位部包括设于关节部510的壁上的一对插入限位部514，两端的翼部522a分别插入一个插入限位部514内后由关节部510的壁卡持。该限位插槽514为设于关节部510的壁内的夹层槽，两个限位插槽514在关节部510的周向上间隔设置且朝向彼此。安装穿线扣52时，先压缩穿线部522b，使两端的翼部522a相互靠近，两端的翼部522a分别对准两个限位插槽514内，松开穿线部522b，穿线部522b恢复形变，两端的翼部522a自动卡入两侧的限位插槽514内，驱动丝110可以在穿线扣52安装前放置，也可以在穿线扣52安装后穿设。可以理解，撤去外力后，两端的翼部522a可以弹性抵接两个插入限位部514，也可以不弹性抵接而仅仅是容纳于其中。
如图19F，该限位插槽514为贯穿关节部510的壁的孔，穿线扣52的安装方法与图19E的实施例相同。当插入限位部514为孔时，两端的翼部522a在被压缩状态下穿过对应的孔后恢复形变而撑开，由关节部510另一侧的壁限位；当插入限位部514为开设于壁内夹层的槽时，两端的翼部522a在被压缩状态下插入对应的槽内后恢复形变而撑开，由槽的夹层侧壁阻挡其脱出。
如图19G，还可以将两端的翼部522a之间的穿线部522b做成拱起部，例如，弧度大于180°的半环形，使穿线部522b与两侧的翼部522a之间形成V形的构造，当两端的翼部522a卡入两侧的限位插槽514内后，该V 形的构造将关节部510的壁夹设于其中，还能阻止穿线扣52径向移动，尤其是图19F所示限位插槽514为孔的情形。
如图19H，限位部包括设于关节部510的壁上的夹层515，夹层515包括主体部516和将主体部516分隔成两部分的豁口部517。主体部516的左右两部分分别与关节部510的壁之间形成一个夹层空间M，两个夹层空间M沿关节部510的周向上朝向彼此。在安装弹片522时，首先压缩弹片522，使两端的翼部522a相互靠近直至二者之间的间距使其可以插入左右的夹层空间M，当翼部522a压缩到一定程度后，撤去外力，两端的翼部522a插入左右的夹层空间M内。为了防止部522a从上方滑出，主体部516的两部分分别包括朝向豁口部517延伸的防脱部518，弹片522的穿线部522b被压缩后，两端的翼部522a分别插入一个夹层空间M内，翼部522a由防脱部518限制脱出。
可以理解的是，弹片522的翼部522a可以经由防脱部518沿轴向(如图自19H所示的上方朝下)插入夹层515与关节部510的壁之间，在穿线部522b未被压缩时，翼部522a内侧之间的距离大于豁口部517的宽度，当穿线部522b被压缩后，翼部522a内侧之间的距离小于豁口部517的宽度，翼部522a可以由防脱部518与关节部510的壁之间的缝隙滑入夹层空间M，在随后撤去施加在穿线部522b上的外力后，穿线部522b恢形变，两侧的翼部522a张开而完全限位在对应的夹层空间M内；或者，在有的实施方式中，也可以直接将穿线部522b被压缩至翼部522a外侧之间的距离小于左右夹层空间M的内缘间距后，将其对准左右的夹层空间M然后在形变恢复力下插入。
可以理解的是，以上所示的几种不同的实施方式可以互相结合，例如，图19H中的关节部510的壁的结构可以与图19E～19G的弹片522配合使用，穿线通道520也可以是由封闭的环状构造形成。又例如，穿线通道520可以安装后位于关节部510外；第一管体111内的穿线扣52与限位部的结构可以包括上述的一种或多种。
本实施例的第一管体111可以是各种结构造型，图16～17示出了一种第一管体111的构造，图20～21C示出了另一种第一管体的构造，图22～23C示出了又一种第一管体的构造，图24示出了再一种第一管体的构造。
如图16～17，该实施例中，节点511被构造为连接梁511a，每两段相邻的关节部510之间通过两根位于其径向上不同侧的连接梁511a固定连接。在其他实施方式中，连接梁511a的数量也可以适当增加，例如3根、4根……，又例如，径向上的其中一侧可以设置两根彼此接近的连接梁511a。
示例性地，关节主体51近端的连接梁511a的宽度大于关节主体51远端的连接梁511a的宽度，使得在驱动丝的驱动下，关节主体51远端先弯曲，更加复合解剖学特点。例如，越靠近关节主体51远端的连接梁511a，其宽度越小，呈线性递减趋势；或者，关节主体51具有多个曲率变化段，每个曲率变化段内的连接梁511a的宽度相同，越靠近关节主体51远端的曲率变化段内的连接梁511a，其宽度越小，呈阶梯递减趋势。另外，也可以将关节主体51近端的连接梁511a的长度设置成小于关节主体51远端的连接梁511a的长度，例如，连接梁511a的长度线性变化或阶梯变化，也能实现类似的效果。
连接梁511a可以与关节主体51一体切割形成，连接梁511a的两侧挖空形成弧形的形变孔H1和连通各形变孔H1的偏转间隔H2，偏转间隔H2将相邻的两段关节部510在轴向上分隔开，使得连接梁511a被驱动弯曲时，相邻的两段关节部510在连接梁511a两侧的距离(即偏转间隔H2)发生变化，通过将关节部510朝向偏转间隔H2的表面设置为扩口的斜面，可以在相同尺寸的偏转间隔H2下，使得相邻的两段关节部510可以更靠近，关节主体51在该处实现更大的弯曲形变。示例性地，自关节主体51近端朝向远端，偏转间隔H2还可以设置为线性增大或阶梯增大，使得关节主体51远端具有更大的弯曲形变量。
如图20～21C，该实施例中，节点511包括分别设于相邻的两段关节部510上的公连接头5111、母连接头5112。公连接头5111通过第一凸弧面5111a至少部分可转动地插设于母连接头5112的第一凹弧面5112a内；第一凸弧面5111a、第一凹弧面5112a面向彼此，两个第一凹弧面5112a均相对于公连接头5111的转动中心线倾斜，且均朝向关节部510外倾斜或均朝向关节部510内倾斜。
公连接头5111、母连接头5112朝向彼此，公连接头5111的自由端呈圆盘形，圆盘形的边缘具有C形的第一凸弧面5111a，母连接头5112的自由端具有呈与圆盘形互补的凹槽，该凹槽具有第一凹弧面5112a和连通第 一凹弧面5112a的缺口5112c。第一凸弧面5111a嵌设于第一凹弧面5112a内并与之间隙配合，缺口5112c的至少部分容纳公连接头5111的非自由端并利用其壁(图21C中上下壁)限制第一凸弧面5111a在第一凹弧面5112a内转动的角度范围。
示例性地，两段相邻的关节部510之间具有两个位于其径向上不同侧的节点511，两个位于其径向上不同侧的节点511中，每个节点511的第一凸弧面5111a、第一凹弧面5112a为面向彼此的倾斜面，且相对于公连接头5111的转动中心线，两个第一凹弧面5112a均朝关节组件外倾斜或均朝关节组件内倾斜。图21B、21C中示出的是第一凹弧面5112a为朝关节组件外的倒角面，第一凸弧面5111a为朝关节组件内的倒角面的情形，二者的角度基本互补。结合图21B、21C所示，由于径向上相对的两个第一凸弧面5111a均朝关节组件内倾斜、两个第一凹弧面5112a均朝关节组件外倾斜，从图21C所示的截面看，单个第一凸弧面5111a围成内小外大的盘状构造，单个第一凹弧面5112a围成内小外大的倒锥形通孔，当两段相邻的关节部510具有径向上相对运动的趋势时，两个第一凹弧面5112a均阻止与之配合的第一凸弧面5111a朝径向内侧运动，二者之间间隙配合，允许在一定角度范围内相对转动。此种结构可以通过激光切割形成一体式结构，例如图21C所示，通过激光切割使两个节点511关于关节部510的中心旋转对称设置。因此，切割形成的相邻的两段关节部510上的公连接头5111、母连接头5112仍然连成一体而不分离。可以理解的是，当两个第一凹弧面5112a均朝内倾斜形成内大外小的锥形通孔时，也能实现公连接头5111、母连接头5112连成一体而不分离的效果。
示例性地，位于关节组件的远端的第一凸弧面5111a在第一凹弧面5112a内转动的角度范围大于位于关节组件的近端的第一凸弧面5111a在第一凹弧面5112a内转动的角度范围。例如，自关节组件的近端朝向远端，第一凸弧面5111a在第一凹弧面5112a内转动的角度范围逐渐线性增大或阶梯增大。
除了第一凸弧面5111a、第一凹弧面5112a的配合外，本实施例的母连接头5112还可以进一步包括第一C形臂C1，第一凹弧面5112a设于第一C形臂C1的内缘，第二凸弧面5112b设于第一C形臂C1的外缘。与之对应，节点511还包括第二凹弧面5111b，第二凹弧面5111b自公连接头5111的 非自由端的两侧延伸并与第一凸弧面5111a同心，各第一凸弧面5111a、第一凹弧面5112a、第二凹弧面5111b、第二凸弧面5112b同心设置，第二凸弧面5112b与第二凹弧面5111b间隙配合，可以是环形管通过激光切割而分离开。示例性地，第二凸弧面5112b、第二凹弧面5111b还可以为面向彼此的倾斜面，图21B中示出的是第二凹弧面5111b朝关节组件外倾斜、第二凸弧面5112b朝关节组件内倾斜的情形，在其他实施方式中，也可以是第二凹弧面5111b朝关节组件内倾斜、第二凸弧面5112b朝关节组件外倾斜，径向上相对设置的两组第二凸弧面5112b、第二凹弧面5111b也可以起到防止径向分离的效果。
第一C形臂C1的内外缘即第一凹弧面5112a、第二凸弧面5112b，其自由端形成缺口5112c，公连接头5111的非自由端的上/下壁分别与第二凹弧面5111b、第一凸弧面5111a围成供第一C形臂C1容纳于其中的两个弧形槽，第二凹弧面5111b、第一凸弧面5111a作为弧形槽的内外弧面，当公连接头5111相对于母连接头5112相对转动时，弧形槽作为引导第一C形臂C1滑动的导向部分，而第一C形臂C1的缺口5112c端面与公连接头5111的非自由端的上/下壁之间的弧槽弧度即用来限制公连接头5111相对母连接头5112的转动角度。
示例性地，与关节主体51的近端相比，在关节主体51的远端侧的第一C形臂C1自由端与公连接头5111的侧面之间的间隔弧度(也可称弧槽弧度)之和θ1+θ2更大。或者，与关节主体51的近端相比，在关节主体51的远端侧的两段相邻的关节部510之间的关节切角θ3+θ4更大，这里，上下的间隔弧度θ1、θ2相等，θ3、θ4相等，在其他实施方式中，θ1、θ2也可以不相等，θ3、θ4也可以不相等。上述设置可以使得远端的关节部510具有更大的弯曲角度。
例如，从关节主体51的近端至远端，第一C形臂C1自由端与公连接头5111的侧面之间的间隔弧度之和θ1+θ2(或两段相邻的关节部510之间的关节切角θ3+θ4)逐渐增大；或者，关节主体51被划分为多个区段，每个区段内的第一C形臂C1自由端与公连接头5111的侧面之间的间隔弧度之和θ1+θ2(或两段相邻的关节部510之间的关节切角θ3+θ4)相等，但越靠近远端的区段，第一C形臂C1自由端与公连接头5111的侧面之间的 间隔弧度之和θ1+θ2(或两段相邻的关节部510之间的关节切角θ3+θ4)越大。
如图22～23C，该实施例中，公连接头5111的自由端还进一步包括第二C形臂C2，第二C形臂C2设于第一凸弧面5111a的外围，第二凹弧面5111b设于第二C形臂C2内缘，第三凸弧面5111c设于第二C形臂C2的外缘，第三凸弧面5111c与第二凹弧面5111b、第一凸弧面5111a同心。第二C形臂C2与圆盘形的边缘形成第一C形臂C1的容纳和转动空间。为配合第二C形臂C2的外缘，节点511还包括自母连接头5112的非自由端的上下两侧延伸并与第一凹弧面5112a同心的第三凹弧面5112d，第三凸弧面5111c与第三凹弧面5112d间隙配合。
在公连接头5111、母连接头5112相对转动的过程中，第二C形臂C2端部的缺口与母连接头5112的非自由端配合，当其缺口与母连接头5112的非自由端(即第一C形臂C1的非自由端)之间的弧槽弧度θ’1(或θ’2)小于对应的第一C形臂C1的缺口5112c与公连接头5111的非自由端之间的弧槽弧度θ1(或θ2)时，该第二C形臂C2可用来与母连接头5112的非自由端配合，限制第三凸弧面5111c在第三凹弧面5112d内转动的角度范围；反之，当其缺口与母连接头5112的非自由端之间的弧槽弧度θ’1(或θ’2)大于对应的第一C形臂C1的缺口5112c与公连接头5111的非自由端之间的弧槽弧度θ1(或θ2)时，第一凸弧面5111a在第一凹弧面5112a内转动的角度范围则由第一C形臂C1来限定。第一C形臂C1与第二C形臂C2、公连接头5111的第一凹弧面5112a配合，可以实现更稳固的转动引导作用。
示例性地，当第三凸弧面5111c与第三凹弧面5112d为面向彼此的倾斜面时，还能进一步增强限制相邻两段关节部510径向脱出的效果。两个第三凹弧面5112d可以均朝关节组件外倾斜，也可以均朝关节组件内倾斜。
例如，与关节主体51的近端相比，在关节主体51的远端侧的第二C形臂C2自由端与母连接头5112的侧面之间的间隔弧度之和θ’1+θ’2更大。具体的设置方式可以是，从关节主体51的近端至远端，第二C形臂C2自由端与母连接头5112的侧面之间的间隔弧度之和θ’1+θ’2逐渐增大；或者，关节主体51被划分为多个区段，每个区段的第二C形臂C2自由端与母连接头5112的侧面之间的间隔弧度之和θ’1+θ’2相等，但越靠近远端的区段， 第二C形臂C2自由端与母连接头5112的侧面之间的间隔弧度之和θ’1+θ’2越大。
应当理解，上述实施例仅仅示出了母连接头5112具有1个C形臂和公连接头5111、母连接头5112分别具有1个C形臂的情形，在其他实施方式中，公连接头5111、母连接头5112上的C形臂的数量可以增加，只需要保证公、母连接头上相应的弧面同心即可。
如图24，与上述一体式关节主体的构造不同，该实施例中的关节主体由多段分体式关节部510连接而成，节点511被构造为铰接轴，每两段相邻的关节部510之间通过径向上对称设置的两个铰接轴铰接。其中的穿线扣52形成为凹进关节部510内的拱起部，这种结构的穿线扣52可以采用冲压的方式在关节部510的壁上一体制作而成。在其他实施方式中，也可以采用焊接等方式将穿线扣52固定在关节部510的壁上。
在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不必须针对的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任一个或多个实施例或示例中以合适的方式结合。此外，在不相互矛盾的情况下，本领域的技术人员可以将本说明书中描述的不同实施例或示例以及不同实施例或示例的特征进行结合和组合。
尽管上面已经示出和描述了本发明的实施例，可以理解的是，上述实施例是示例性的，不能理解为对本发明的限制，本领域的普通技术人员在本发明的范围内可以对上述实施例进行变化、修改、替换和变型。

Claims (14)

  1. 一种关节组件，用于柔性手术器械中，其特征在于，包括：
    关节主体(51)，包括多段关节部(510)、联接相邻的两段所述关节部(510)的节点(511)以及沿长度方向上间隔地设于所述关节主体(51)上的多个限位部；
    多个穿线扣(52)，所述穿线扣(52)设于所述限位部上并设有供驱动丝(110)穿过的穿线通道(520)，至少一个所述穿线扣(52)可拆卸地固定在所述限位部上；
    其中，相邻的所述关节部(510)被配置为可在所述驱动丝(110)的张力下绕二者之间的节点(511)产生相对偏转。
  2. 根据权利要求1所述的关节组件，其特征在于，所述限位部包括贯穿所述关节部(510)的壁的第一通孔(513)，所述穿线扣(52)包括设有所述穿线通道(520)的头部和设有阻挡部(521)的尾部；
    所述穿线扣(52)的尺寸被配置为允许所述头部穿出所述第一通孔(513)外，且限制所述阻挡部(521)穿过所述第一通孔(513)。
  3. 根据权利要求2所述的关节组件，其特征在于，所述穿线扣(52)呈楔形。
  4. 根据权利要求2所述的关节组件，其特征在于，所述阻挡部(521)包括所述穿线扣(52)尾部的两个限位脚(5210)，两个所述限位脚(5210)背向彼此张开而被所述第一通孔(513)的边缘限制进入所述第一通孔(513)。
  5. 根据权利要求1所述的关节组件，其特征在于，所述穿线扣(52)包括弹片(522)，所述弹片(522)包括两端的翼部(522a)和中间的穿线部(522b)；
    两端的所述翼部(522a)分别由所述限位部限位在所述关节部(510)的周向上的不同部位，所述穿线部(522b)至少部分围成所述穿线通道(520)。
  6. 根据权利要求5所述的关节组件，其特征在于，所述限位部包括设于所述关节部(510)的壁上的一对插入限位部(514)，所述一对插入限位部(514)为孔或槽，在所述关节部(510)的周向上设置；
    两端的所述翼部(522a)分别插入一个所述插入限位部(514)内后由所述关节部(510)的壁卡持。
  7. 根据权利要求5所述的关节组件，其特征在于，所述限位部包括设于所述关节部(510)的壁上的夹层(515)，所述夹层(515)包括主体部(516)和将所述主体部(516)分隔成两部分的豁口部(517)；
    所述主体部(516)的两部分分别与所述关节部(510)的壁之间形成一个夹层空间(M)，两个所述夹层空间(M)沿所述关节部(510)的周向上朝向彼此；
    所述主体部(516)的两部分分别包括朝向所述豁口部(517)延伸的防脱部(518)；所述弹片(522)被配置为所述穿线部(522b)被压缩后，两端的所述翼部(522a)分别插入一个所述夹层空间(M)内，并由所述防脱部(518)限制从所述夹层空间(M)脱出。
  8. 根据权利要求1所述的关节组件，其特征在于，用于穿设其中一根所述驱动丝(110)的第一组穿线通道(520)都位于所述关节部(510)的壁内，和/或，用于穿设其中一根所述驱动丝(110)的第二组穿线通道(520)都位于所述关节部(510)的壁外。
  9. 根据权利要求1所述的关节组件，其特征在于，所述节点(511)包括连接梁(511a)，每两段相邻的所述关节部(510)之间通过至少两根位于其径向上不同侧的所述连接梁(511a)固定连接；
    所述关节主体(51)近端的连接梁(511a)的宽度大于所述关节主体(51)远端的连接梁(511a)的宽度，和/或，所述关节主体(51)近端的连接梁(511a)的长度小于所述关节主体(51)远端的连接梁(511a)的长度。
  10. 根据权利要求1～9任一所述的关节组件，其特征在于，每段所述关节部(510)均包括两个所述限位部，相邻的两段所述关节部(510)的所述限位部在所述关节组件的周向上错开。
  11. 一种导管，其特征在于，包括驱动丝(110)、柔性的第二管体(112)和权利要求1～10任一所述的关节组件，所述关节组件连接在所述第二管体(112)的远端，所述驱动丝(110)的一端设于所述关节组件的远端，另 一端沿长度方向依次穿过所述关节组件上对应的穿线通道(520)后引出至所述第二管体(112)的近端。
  12. 根据权利要求11所述的导管，其特征在于，还包括连接所述关节组件和所述第二管体(112)的连接环(113)，所述连接环(113)的远端外壁凸设有多个加厚部(1131)，所述关节组件的近端开设有被配置为供所述加厚部(1131)插设的安装插槽(111C)。
  13. 根据权利要求12所述的导管，其特征在于，还包括套设于所述驱动丝(110)外并可在轴向上被压缩的弹性管(110a)，所述加厚部(1131)的内表面设有轴向延伸的容纳槽(1132)，所述弹性管(110a)和/或所述驱动丝(110)至少部分容纳于所述容纳槽(1132)内。
  14. 一种柔性手术器械，其特征在于，包括外鞘(20)和权利要求11～13任一所述的导管，所述导管被配置为可拆卸地插入和拔出所述外鞘(20)。
PCT/CN2023/106947 2022-07-09 2023-07-12 柔性手术器械、导管及关节组件 WO2024017109A1 (zh)

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