Distal steerable medical instrument and robotic surgical system

Abstract

The invention provides a far-end controllable medical instrument and a robotic surgery system using the instrument. The far-end controllable medical instrument integrates far-end bending capacity, end effector execution capacity and motion response capacity. According to the actuator actuating wire, the flexural rigidity of the small part of the far end is smaller than the flexural rigidity of the large part of the near end in the length direction, the body part of the large part of the near end bears force transmission, and the first bending part of the small part of the far end can receive large-amplitude passive bending; according to the actuator actuating wire, the axial movement performance (pushability) and the bending performance (flexibility) are both considered, and in other words, on the premise that the bending effect of the controllable arm is met, the end actuator can obtain enough force for corresponding examination and treatment operation and good movement response capacity.

Description

Technical Field

[0001] The invention relates to a remotely manipulable medical device and a robotic surgery system. Background Art

[0002] A distally manipulable medical device has a manipulator at its proximal end, and the distal end can be manipulated to bend. It has an actuator wire, and the position and posture of the end effector can be directly controlled by pushing and pulling the actuator wire; it is easy to understand that the change in the position of the distal end of the medical device can also lead to the change in the position of the end effector, and the actuator wire is passively bent at this time.

[0003] A specific example is a medical device used in conjunction with a gastroscope. Usually, the diameter of the instrument channel of a gastroscope is about 3 mm, which requires that the diameter of the part of the medical device that passes through the instrument channel should not be larger than the diameter of the instrument channel. When the diameter of that part is 3 mm or less, it will cause the deflection torque of the distal end of the medical device to decrease, making it more difficult to manipulate the distal end of such medical devices. One factor that affects the bending performance of medical devices is the bending stiffness of the actuator wire. When the bending stiffness of the actuator wire is large, it is not easy to bend passively, which will affect the manipulation effect of the distal end of the medical device.

[0004] At the same time, since the medical device is a slender structure, in order to maintain the execution force of the end effector (especially the force to achieve traction, holding, grasping and other operations) and the response speed, the actuator wire needs to be maintained at an effective diameter. Simply reducing the overall diameter of the actuator wire will easily cause the actuator wire itself to bend when a push-pull force is applied to the actuator wire, which will lead to a decrease in the execution ability of the end effector at its distal end and a hysteresis in the movement of the end effector (a decrease in the response speed). Summary of the invention

[0005] The present invention provides a distally manipulable medical device having both distal bending capability, end effector execution capability and motion response capability, and a robotic surgery system using the device.

[0006] A remotely manipulable medical device, the medical device comprising:

[0007] A manipulable arm, which can be manipulated to be bent, and is configured to have a first inner cavity that runs through the length direction of the manipulable arm;

[0008] an end effector carried by the manipulable arm, the end effector being operably controlled by an effector actuation wire;

[0009] Wherein, the actuator actuating wire has a main body portion and a first bending portion along its own length, the first bending portion extends in the first inner cavity of the manipulable arm and is connected to the end actuator, the actuator actuating wire is allowed to be axially advanced and retracted, and the first bending portion is passively bent when the manipulable arm is bent, and the first bending portion has a bending stiffness smaller than that of the main body portion.

[0010] Preferably, a cross-sectional area of ​​the first curved portion is smaller than a cross-sectional area of ​​the main body portion.

[0011] Preferably, the main body and the first bent portion are integrally constructed by welding, or the first bent portion is obtained by partial grinding of the main body.

[0012] Preferably, the first curved portion comprises a transition section.

[0013] Preferably, the first curved portion has a first starting point located at the end of the main body portion, and the first starting point is located outside the first inner cavity covered by the maneuverable arm.

[0014] Preferably, the end effector is connected to the first curved portion via a first connecting member, the first connecting member is configured with a sleeve structure, the outer diameter of the distal end of the first curved portion matches the inner diameter of the sleeve structure, and the distal end of the first curved portion is inserted into the sleeve structure and fixed.

[0015] Preferably, the steerable arm is configured to be actuated to bend by at least one bending actuation wire.

[0016] Preferably, the maneuverable arm is formed by a plurality of curved segments connected in series.

[0017] Preferably, the maneuverable arm is formed by making at least one cut in a metal tube.

[0018] Preferably, the medical device further comprises a sheath, wherein the sheath defines a travel path of the actuator actuating wire.

[0019] Preferably, the sheath is made of a lubricating material.

[0020] Preferably, the sheath is configured as a wire spiral tube.

[0021] A distally manipulable medical device, which is delivered to a treatment site through an instrument channel of an endoscope, comprising:

[0022] A manipulable arm, which can be manipulated to be bent, and is configured to have a first inner cavity that runs through the length direction of the manipulable arm;

[0023] an end effector carried by the manipulable arm, the end effector being operably controlled by an effector actuation wire;

[0024] Wherein, the actuator actuating wire has a main body portion and a first bending portion along its own length, the first bending portion extends in the first inner cavity of the manipulable arm and is connected to the end actuator, the actuator actuating wire is allowed to be axially advanced and retracted, and the first bending portion is passively bent when the manipulable arm is bent, and the first bending portion has a bending stiffness smaller than that of the main body portion.

[0025] Preferably, a cross-sectional area of ​​the first curved portion is smaller than a cross-sectional area of ​​the main body portion.

[0026] Preferably, the main body and the first bent portion are integrally constructed by welding, or the first bent portion is obtained by partial grinding of the main body.

[0027] Preferably, the first curved portion comprises a transition section.

[0028] Preferably, the medical instrument passes through the instrument channel, and an instrument channel outlet at the distal end of the instrument channel provides an anchor point to support the bending of the maneuverable arm extending out of the instrument channel.

[0029] Preferably, the first curved portion has a first starting point located at the end of the main body portion, and during use of the medical device, the first starting point does not exceed the anchor point.

[0030] Preferably, the first curved portion has a first starting point located at the end of the main body portion, and the first starting point is located outside the first inner cavity covered by the maneuverable arm.

[0031] Preferably, the end effector is connected to the first curved portion via a first connecting member, the first connecting member is configured with a sleeve structure, the outer diameter of the distal end of the first curved portion matches the inner diameter of the sleeve structure, and the distal end of the first curved portion is inserted into the sleeve structure and fixed.

[0032] Preferably, the medical device is provided with a torque decoupling member to decouple the torque applied to the manipulable arm from the torque applied to the actuator actuating wire.

[0033] Preferably, the torque separation member is configured in a circular ring shape, and the torque separation member is defined between an inner circumference of the manipulable arm and an outer circumference of the first connecting member.

[0034] Preferably, the torque separation member is configured as a bearing, the bearing comprising an outer ring and an inner ring, the outer ring and the inner ring being connected to the manipulable arm and the first connecting member respectively.

[0035] Preferably, the steerable arm is configured to be actuated to bend by at least one bending actuation wire.

[0036] Preferably, the steerable arm is configured as a flexible tube.

[0037] Preferably, the maneuverable arm is formed by a plurality of curved segments connected in series.

[0038] Preferably, the maneuverable arm is formed by making at least one cut in a metal tube.

[0039] Preferably, the steerable arm is configured as a wire coil.

[0040] Preferably, the medical device further comprises a sheath, wherein the sheath defines a travel path of the actuator actuating wire.

[0041] Preferably, the sheath is made of a lubricating material.

[0042] Preferably, the sheath is configured as a wire spiral tube.

[0043] A distally manipulable medical device, which is attached to the exterior of the distal end of an endoscope via a parallel connection and is delivered to a treatment site along with the endoscope, the medical device comprising:

[0044] A manipulable arm, which can be manipulated to be bent, and is configured to have a first inner cavity that runs through the length direction of the manipulable arm;

[0045] an end effector carried by the manipulable arm, the end effector being operably controlled by an effector actuation wire;

[0046] Wherein, the actuator actuating wire has a main body portion and a first bending portion along its own length, the first bending portion extends in the first inner cavity of the manipulable arm and is connected to the end actuator, the actuator actuating wire is allowed to be axially advanced and retracted, and the first bending portion is passively bent when the manipulable arm is bent, and the first bending portion has a bending stiffness smaller than that of the main body portion.

[0047] Preferably, a cross-sectional area of ​​the first curved portion is smaller than a cross-sectional area of ​​the main body portion.

[0048] Preferably, the main body and the first bent portion are integrally constructed by welding, or the first bent portion is obtained by partial grinding of the main body.

[0049] Preferably, the first curved portion comprises a transition section.

[0050] Preferably, the medical device extends out through the parallel connector, and the second port portion at the distal end of the parallel connector provides an anchor point to support the bending of the steerable arm detached from the parallel connector.

[0051] Preferably, the first curved portion has a first starting point located at the end of the main body portion, and during use of the medical device, the first starting point does not exceed the anchor point.

[0052] Preferably, the first curved portion has a first starting point located at the end of the main body portion, and the first starting point is located outside the first inner cavity covered by the maneuverable arm.

[0053] Preferably, the end effector is connected to the first curved portion via a first connecting member, the first connecting member is configured with a sleeve structure, the outer diameter of the distal end of the first curved portion matches the inner diameter of the sleeve structure, and the distal end of the first curved portion is inserted into the sleeve structure and fixed.

[0054] Preferably, the medical device is provided with a torque decoupling member to decouple the torque applied to the manipulable arm from the torque applied to the actuator actuating wire.

[0055] Preferably, the torque separation member is configured in a circular ring shape, and the torque separation member is defined between an inner circumference of the manipulable arm and an outer circumference of the first connecting member.

[0056] Preferably, the torque separation member is configured as a bearing, the bearing comprising an outer ring and an inner ring, the outer ring and the inner ring being connected to the manipulable arm and the first connecting member respectively.

[0057] Preferably, the steerable arm is configured to be actuated to bend by at least one bending actuation wire.

[0058] Preferably, the steerable arm is configured as a flexible tube.

[0059] Preferably, the maneuverable arm is formed by a plurality of curved segments connected in series.

[0060] Preferably, the maneuverable arm is formed by making at least one cut in a metal tube.

[0061] Preferably, the steerable arm is configured as a wire coil.

[0062] Preferably, the medical device further comprises a sheath, wherein the sheath defines a travel path of the actuator actuating wire.

[0063] Preferably, the sheath is made of a lubricating material.

[0064] Preferably, the sheath is configured as a wire spiral tube.

[0065] A robotic surgery system using the above-mentioned medical instrument, the robotic surgery system includes an instrument controller, the medical instrument includes a manipulator, the manipulator is configured with an interface coupled to the instrument controller, when the manipulator is coupled to the instrument controller, the manipulator can be controlled to manipulate the bending of the manipulator arm, and the manipulator can advance or retract the actuator actuating wire; when the manipulator is decoupled and separated from the instrument controller, the two no longer operate together.

[0066] Preferably, the manipulator is provided with a torque transmission member, which is fixed to the proximal end of the actuator actuating wire. When the manipulator is coupled to the instrument controller, the manipulator can be controlled to manipulate the actuator actuating wire to rotate around its own axis.

[0067] The medical device of the present invention arranges the actuator wire in the length direction so that the bending stiffness of the distal small part is smaller than the bending stiffness of the proximal large part. The main body of the proximal large part is responsible for force transmission, and the first bending part of the distal small part can accept a relatively large passive bending. The actuator wire is able to take into account both axial movement performance (pushability) and bending performance (flexibility). That is, under the premise of satisfying the bending effect of the manipulable arm, the end effector can obtain sufficient force and good movement response capability for corresponding inspection and treatment operations. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Figure 1 A schematic diagram of the connection structure between the actuator wire and the end actuator provided by one embodiment of the present invention;

[0069] Figure 2 A schematic diagram of the connection structure of a manipulable arm and an end effector provided in one embodiment of the present invention (the bending actuator wire is not shown);

[0070] Figure 3 for Figure 2 An exploded view of the distal end of the medical device in an embodiment (the bending actuation wire is not shown);

[0071] Figure 4 for Figure 2 A schematic structural diagram of an end effector in an embodiment;

[0072] Figure 5 for Figure 2 A schematic structural diagram of a fork-shaped connecting member in an embodiment;

[0073] Figure 6 for Figure 2 A schematic structural diagram of a first connecting member in an embodiment;

[0074] Figure 7 and Figure 8A schematic diagram of a partial structure of a manipulable arm provided in accordance with an embodiment of the present invention (actuator actuating wires and bending actuating wires are not shown);

[0075] Fig. 9 This is a schematic diagram of the structure of a traditional gastroenteroscopy;

[0076] Fig.10 A schematic diagram of the structure of a medical device provided by one embodiment of the present invention;

[0077] Fig.11 , Fig.12 , Fig.13 They are schematic diagrams of the connection structures of the manipulable arms and the bending actuating wires in several embodiments of the present invention;

[0078] Fig.14 A schematic diagram of the connection structure of a manipulable arm, a sheath and an actuator actuating wire provided in one embodiment of the present invention (the bending actuating wire is not shown);

[0079] Fig.15 A schematic diagram of the connection structure between a medical device provided by another embodiment of the present invention and a traditional gastroenteroscope;

[0080] Fig.16 for Fig.15 Schematic diagram of the connection structure of the manipulable arm and the bending actuating wire in the embodiment;

[0081] Fig.17 and Fig.18 A schematic diagram of the internal structure of a manipulator provided by one embodiment of the present invention;

[0082] Fig.19 for Fig.17 A schematic structural diagram of a first sliding block in an embodiment;

[0083] Fig. 20 for Fig.17 A schematic structural diagram of the second sliding block in the embodiment.

[0084] The reference numerals involved are as follows:

[0085] The operating part 110, the insertion part 120, the second bending part 130, the instrument channel entrance 140, the front hard part 150, the instrument channel exit 160, the parallel connection 170, the auxiliary channel exit 171, the manipulator 200, the first slider 210, the first guide hole 211, the second guide hole 212, the third guide hole 213, the boss 214, the second slider 220, the third slider 230, the base 250, the guide rod 261, the sheath 300, the manipulator arm 400, the first inner cavity 401, the second inner cavity 402, the extension hole 403, the curved segment 4 04, sheath 405, inner layer 406, outer layer 407, bending actuator wire 410, torque separator 420, end actuator 500, first link 501, second link 502, first pivot pin 505, third link 503, fourth link 504, second pivot pin 506, first connecting member 507, sleeve structure 508, second connecting member 509, actuator actuator wire 510, main body 511, first bend 512, transition section 513, first starting point 514, fork-shaped connecting member 521, tube 522, arm 523. DETAILED DESCRIPTION

[0086] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0087] In the description of the present invention, the terms "proximal end" and "distal end" will be used to describe the axially opposite ends of the instrument and the axial ends of various component features. The term "proximal end" is used in its conventional sense to refer to the end of the device (or component) that is closest to the medical professional during use of the assembly. The term "distal end" is used in its conventional sense to refer to the end of the device (or component) that is initially inserted into the patient's body, or closest to the patient during use.

[0088] It should also be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "connected" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, or it can be the internal communication of two components. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0089] The medical device of the embodiment of the present invention is suitable for entering the body through the natural cavity or micro-incision of the human body for inspection and treatment. The medical device can be used alone or attached to another main device and transported to the treatment site together with the main device for inspection and treatment. The inspection and treatment operations mentioned here can be traction, holding, grasping, suturing, electrocoagulation, cutting, etc.

[0090] The medical device of the embodiment of the present invention includes a manipulator 200, a manipulatable arm 400 and an end effector 500. The manipulator 200 is used to manipulate the bending of the manipulatable arm 400 and to manipulate the end effector 500 for inspection and treatment. The manipulator 200 can be manual or electric. The manual manipulator 200 is respectively connected to the bending actuator wire 410 and the actuator actuator wire 510 and provides an operation interface, which is constructed as a slide groove and a slide handle, or a wrench, or a knob provided on the handle. The operator can pull and release the bending actuator wire 410 by operating the operation interface, thereby controlling the bending of the manipulatable arm 400; the operator can also push and pull the actuator actuator wire 510, thereby controlling the end effector 500 for inspection and treatment.

[0091] Fig.10 The manipulator 200 in the illustrated embodiment is suitable for a robotic surgery system, and embodiments suitable for a robotic surgery system will be further described below.

[0092] In the embodiment of the manual manipulator 200, the proximal end of the manipulator arm 400 is connected to the sheath 300. The sheath 300 is constructed as a rigid or semi-rigid tubular structure to provide necessary support and stability. The sheath 300 serves as a channel for transmitting actuating wires or other functional connectors, and its proximal end and distal end are respectively connected to the manipulator 200 and the manipulator arm 400.

[0093] The manipulator arm 400 is configured to be positioned according to the actuation of the manipulator 200. In some embodiments, the manipulator arm 400 may include one or more curved segments, and the curved segments may be a continuous structure driven by a cable.

[0094] The manipulable arm 400 carries an end effector 500, which is operably controlled by an effector actuating wire 510. The manipulable arm is configured to have a first lumen 401 extending through its length to accommodate the effector actuating wire 510. Figure 2 , Figure 7 In the embodiment shown, the first inner cavity 401 is located at the longitudinal center axis of the manipulable arm 400. Although not shown in the figure, it is understood that Figure 2 , Figures 11 to 13 In the illustrated embodiment, the actuator actuation wire 510 extends from the end effector 500 to the proximal manipulator 200 through the first lumen 401 of the steerable arm 400 and the lumen of the sheath 300 .

[0095] The end effector 510 can be smooth jaws, serrated jaws, a clamp, scissors, an electric scalpel, a stapler, a needle holder, a stapler, or the like.

[0096] Figure 4In the embodiment shown, the end effector 510 is a serrated jaw. When the actuator wire 510 is advanced and retracted, the distal clamp will open and close, thereby achieving traction / holding / grasping of human tissue. Figure 4 The end actuator shown includes a four-bar linkage mechanism, in which the first link 501 and the second link 502 are connected by a first pivot pin 505, and the third link 503 and the fourth link 504 are connected by a second pivot pin 506. The distal end of the actuator actuating wire 510 is connected to the second pivot pin 506, and the first link 501 and the second link 502 are extended respectively to form a clamp.

[0097] like Figure 3 As shown, a fork-shaped connector 521 is used as an intermediate medium to connect the end effector 500 and the manipulable arm 400, and the fork-shaped connector 521 includes a tube 522 and an arm 523. The tube 522 is sleeved with the distal end of the manipulable arm 400 and fixed by welding; the distal end of the actuator actuating wire 510 passes through the tube 522 and is connected to the second pivot pin 506, and the two ends of the first pivot pin 505 are respectively connected to the arm 523. When the actuator actuating wire 510 is advanced or withdrawn, the position of the first pivot pin 505 is relatively fixed, and the second pivot pin 506 is close to or away from the first pivot pin 505, which is manifested in the action of the distal clamp being opened or closed.

[0098] In another optional structure, the end effector 500 includes a pair of jaws pivotally connected to each other, wherein the actuator actuator wire 510 is operably connected to at least one jaw of the pair of jaws, and wherein actuation of the actuator actuator wire 510 is configured to cause the pair of jaws to pivot relative to each other.

[0099] The actuator wire 510 has a main body 511 and a first curved portion 512 along its length. The first curved portion 512 extends in the first inner cavity 401 of the manipulable arm 400 and is connected to the end effector 500. It should be noted that the connection here can be directly connected or indirectly connected through an intermediate medium. The actuator wire 510 is allowed to be axially advanced and withdrawn, and the first curved portion 512 is passively bent when the manipulable arm 400 is bent. The first curved portion 512 has a smaller bending stiffness than the main body 511.

[0100] Here, we need the actuator wire 510 to be able to effectively transmit the force to the distal end when subjected to the axial force, so as to actuate the distal end actuator 500, and the actuator wire 510 cannot provide more resistance when the manipulable arm 400 is bent. For the slender actuator wire, high bending stiffness means that it can maintain its original straight state when subjected to external force, and is not prone to bending and deformation. Therefore, the first bending portion 512 has a smaller bending stiffness than the main body 511. The main body 511 constitutes most of the actuator wire 510 in the length direction, and can effectively transmit the axial force; the first bending portion 512 constitutes a small part of the actuator wire 510 in the length direction, and is easier to bend passively. Since it accounts for a small proportion in the length direction of the actuator wire 510, its influence on the axial transmission of force is also small.

[0101] The actuator wire 510 is usually made of metal wire. As an example, the actuator wire 510 can be a steel wire or a nickel-titanium wire. In order to obtain a first curved portion 512 with a lower bending stiffness than the main body 511, the main body 511 and the first curved portion 512 can be made of different materials, and the bending stiffness of the first curved portion 512 is only required to be smaller than the bending stiffness of the main body 511.

[0102] In some specific embodiments, the cross-sectional area of ​​the first curved portion 512 is smaller than the cross-sectional area of ​​the main body 511. The smaller cross-sectional area can make the first curved portion 512 have a smaller bending stiffness. The ratio of the cross-sectional area of ​​the main body 511 to the cross-sectional area of ​​the first curved portion 512 can be between three quarters and one third. For example, the diameter of the main body is 0.5 mm, and the diameter of the first curved portion is 0.3 mm.

[0103] The main body 511 and the first curved portion 512 can be integrated by welding. More specifically, the main body 511 and the first curved portion 512 can be connected and welded together at the ends of two slender metal wires by resistance welding. Other welding methods that can be used include pressure welding, friction welding, ultrasonic welding, magnetic welding, laser welding, hot pressure welding, plasma welding, cladding welding, etc.

[0104] In some specific embodiments, the first curved portion 512 is obtained by partially rotating and grinding the main body portion 511. Figure 1In the illustrated embodiment, after partial rotational grinding, a transition section 513 with a gradually changing cross-sectional area may be formed between two sections with different cross-sectional areas. Compared with the bending stiffness of the main body 511, the transition section 513 has begun to have a smaller bending stiffness, so we regard the transition section 513 as a part of the first curved portion 512. For the same reason, we record the end point of the distal end of the main body 511 as the first starting point 514, and the first starting point 514 is also the starting point of the first curved portion 512.

[0105] It should be noted that the so-called "point" of the first starting point 514 is a basic element without size, shape and dimension, used to indicate a position. Figure 1 and Figure 2 As shown, the first starting point 514 may be an area included in the cross section that meets the above conditions.

[0106] In order to achieve the use effect of the present invention and minimize the influence of the actuator wire 510 on the flexible bending of the manipulable arm 400, preferably, the first starting point 514 is located outside the first inner cavity 401 covered by the manipulable arm 400. Furthermore, even when the actuator wire 510 is pushed to the limit position of the preset stroke, the first starting point 514 is still located outside the first inner cavity 401 covered by the manipulable arm 400.

[0107] When the main body 511 and the first curved portion 512 are welded together, the diameter change (cross-sectional area change) is relatively abrupt, and may be adjacent to each other in a step. Of course, we still record the distal end point of the main body 511 as the first starting point 514, which is also the starting point of the first curved portion 512.

[0108] In certain specific embodiments, such as Figure 3 As shown, the end effector 500 is connected to the first bending portion 512 via a first connecting member 507. Figure 6 As shown, one end of the first connecting member 507 is configured with a sleeve structure 508, and a small section of the distal end of the first curved portion 512 is inserted into the sleeve structure 508 and fixed, and the fixing method can be welding. The other end of the first connecting member 507 is provided with a through hole for the second pivot pin 506 to pass through.

[0109] In some specific embodiments, the medical device of the present invention can be attached to another main body device and transported to a treatment site together with the main body device for inspection and treatment. A typical embodiment of the main body device is a medical endoscope.

[0110] A medical endoscope is a medical device that enters the body through a natural cavity or a tiny incision to perform visual inspection and treatment. An endoscope can be either a soft endoscope or a hard endoscope.

[0111] The main components of a medical endoscope include an outer cannula and an imaging system. The outer cannula is constructed as a slender insertion tube with an instrument channel for advancing / retracting other medical instruments.

[0112] Taking soft endoscope as an example, Fig. 9 The gastroenteroscope shown in the figure includes, from near to far, an operating part 110, an insertion part 120, a second bending part 130 and a hard part 150 at the tip. Among them, the operating part 110 is the main area for doctors to control the endoscope to perform various operations, and is equipped with multiple control elements and interfaces for adjusting the posture of the endoscope, performing specific functions and connecting external devices. The operating part 110 is provided with an instrument channel entrance 140 for inserting various treatment tools, such as biopsy forceps, injection needles, etc., so as to perform further inspection or treatment operations under the guidance of the endoscope. The insertion part 120 is the main part of the endoscope entering the human body. The second bending part 130 is the part of the distal end of the endoscope that can be flexibly bent according to the user's operation. Specifically, the second bending part 130 is composed of a plurality of movable annular parts or joints, and these parts can move relative to each other in a preset manner. This design allows the user to control the bending direction and angle of the second bending part 130 through the control rod or angle knob of the operating part 110. The front hard part 150 is a harder part used to protect the optical components (such as the lens group) at the front end. The light guide window and the instrument channel exit are also arranged here.

[0113] In some specific embodiments, the medical device of the present invention can be delivered to the treatment site through the instrument channel of the endoscope for inspection and treatment operations. The inspection and treatment operations mentioned here can be traction, grasping, grasping, suturing, electrocoagulation, cutting, etc.

[0114] Since it is necessary to penetrate the instrument channel, the proximal end of the manipulable arm 400 is connected to a flexible sheath 300 to adapt to the bending operation of the soft endoscope. The distal end of the manipulable arm 400 extends from the instrument channel outlet 160 at the distal end of the instrument channel. The mouth end of the instrument channel outlet 160 provides an anchor point to support the bending of the manipulable arm 400 extending out of the instrument channel, so that the manipulable arm 400 and the end effector 500 obtain a certain position and posture.

[0115] In order to achieve the effect of the present invention, the existence of the actuator wire 510 can minimize the influence on the flexible bending of the manipulable arm 400 by satisfying at least one of the following two conditions:

[0116] The first condition is that, as mentioned above, the first curved portion 512 has a first starting point 514 located at the end of the main body 511. During the use of the medical device, the first starting point 514 does not cross the anchor point (i.e., the mouth end of the instrument channel outlet 160). Furthermore, even when the actuator wire 510 is pushed to the limit position of the preset stroke, the first starting point 514 does not cross the anchor point;

[0117] The second condition is that the first curved portion 512 has a first starting point 514 located at the end of the main body 511, and the first starting point 514 is located outside the first inner cavity 401 covered by the manipulable arm 400, that is, the first starting point 514 does not fall within the range surrounded by the manipulable arm 400, and most of the first curved portion 512 in the length direction falls within the range surrounded by the manipulable arm 400. For example, Figure 2 In the illustrated embodiment, the L region shows the range surrounded by the manipulable arm 400, and the first starting point 514 is located outside the L region; Fig.11 and Fig.12 In the illustrated embodiment, the portion extending from the extension hole 403 to the distal end is regarded as the manipulable arm 400, and the first starting point 514 does not fall within the range surrounded by the manipulable arm 400; Fig.13 In the illustrated embodiment, the portion extending from the nearest end of the cutout on the metal tube to the distal end is regarded as the manipulable arm 400, and the first starting point 514 does not fall within the range surrounded by the manipulable arm 400. Furthermore, even when the actuator wire 510 is advanced to the limit position of the preset stroke, the first starting point 514 is located outside the first inner cavity 401 covered by the manipulable arm 400.

[0118] In some embodiments, the manipulator arm 400 is configured to be actuated to bend by at least one bending actuation wire 410. The bending actuation wire 410 may be disposed within the first lumen 401 (eg, Fig.13 The embodiment shown in the figure) can also be arranged on the periphery of the manipulable arm 400 (such as Fig.11 , Fig.12 , Fig.16 In the embodiment shown in the figure), a second inner cavity 402 (such as the one shown in the figure) for arranging the bending actuator wire 410 can also be constructed in the body of the manipulable arm 400. Figure 8 It should be noted that the above embodiments do not limit the arrangement of the bending actuator wire 410, but illustrate various possibilities of the arrangement of the bending actuator wire 410. Those skilled in the art can flexibly configure the arrangement as required under the guidance of the present invention.

[0119] When the manipulable arm 400 needs to obtain more bending directions, the number of bending actuating wires 410 can be increased, such as using two, three, four, six, eight, or even more. In this case, the multiple bending actuating wires 410 can be evenly distributed or appropriately offset according to the expected bending action of the manipulable arm 400.

[0120] In some specific embodiments, the manipulator arm 400 is configured as a flexible tubular fitting. As previously mentioned, since the medical device of the embodiment of the present invention passes through the instrument channel, the proximal end of the manipulator arm 400 is connected to a flexible sheath 300 to accommodate the bending operation of the soft endoscope. Here, the manipulator arm 400 and the sheath 300 can be an integral structure. The flexible tubular fitting needs to be bent during use, and the actuating wire or other functional connectors need to pass through the lumen, which requires the tubular fitting to provide the necessary support to maintain the stability of the lumen and facilitate the introduction and operation of the actuating wire or other functional connectors. Therefore, the flexible tubular fitting needs to have anti-bending ability. In addition, the flexible tubular fitting also needs to have anti-deformation ability and biocompatibility. To this end, the material of the flexible tubular fitting can be selected from polyurethane (TPU), polytetrafluoroethylene (PTFE), etc.

[0121] The flexible tube can also be a multi-layer braided tube. For example, the inside of the cavity is made of polytetrafluoroethylene (PTFE) material to reduce the friction of the cavity on the actuating wire; the middle layer is woven with stainless steel material to provide sufficient support function to ensure that the sheath will not be squeezed and deformed when passing through the instrument channel of the endoscope, affecting the traction effect of the actuating rope; the outermost layer is polyether block amide (PEBAX) material to provide support and anti-torsion performance.

[0122] In some embodiments where the manipulable arm 400 is configured as a flexible tube, the manipulable arm 400 is embedded with at least one anchoring ring (not shown), and the bending actuating wire 410 is disposed in the side wall of the tube body and extends along the axial direction of the tube body. The two ends of the bending actuating wire 410 are respectively connected to the manipulator 200 and the anchoring ring. By operating the manipulator 200, the bending actuating wire 410 can be pulled and the distal tube body (manipulable arm 400) can be bent.

[0123] In some other embodiments where the maneuverable arm 400 is configured as a flexible tube, Fig.11 As shown, a protrusion hole 403 is provided at the distal end of the sheath tube 300 , and a bending actuator wire 410 originally extending in the cavity of the sheath tube 300 passes through the protrusion hole 403 , and finally its distal end is connected to the distal end of the manipulable arm 400 .

[0124] In some specific embodiments, the manipulator arm 400 is formed by connecting a plurality of curved segments 404 in series. The curved segments 404 can have a variety of different structural forms, and the curved segments 404 can be ring-shaped or block-shaped (e.g. Figure 2The curved segments 404 may be hinged or slidably connected between the protrusions and the grooves (the curved segments 404 are adjacent to each other and can move relative to each other at an angle).

[0125] In such Figure 7 and Figure 8 In the illustrated embodiment, the manipulable arm 400 is constructed with a first lumen 401 and a second lumen 402, which respectively provide paths for the actuator actuating wire 510 and the bending actuating wire 410 to pass through. Figure 8 In the embodiment shown, there are 6 second cavities 402, and for simplicity, only 3 of the second cavities 402 are shown in dashed lines. It is understandable that the through hole provided on each curved segment 404 may form a first cavity 401 and a second cavity 402 to transmit the actuating wire. Figure 7 and Figure 8 In the illustrated embodiment, only four bending segments 404 are shown. The bending segments 404 have inclined surfaces, so that the maneuverable arm 400 can be formed to bend within a certain range.

[0126] In some specific embodiments, the manipulator arm 400 is formed by cutting a metal tube at least once. The cutting method may be transverse cutting, oblique cutting or spiral cutting, and the material of the metal tube may be a memory alloy. Fig.12 In the embodiment shown, the distal end of the sheath tube 300 is provided with an extension hole 403, and the bending actuator wire 410 originally extending in the lumen of the sheath tube 300 passes through the extension hole 403, and finally its distal end is connected to the distal end of the manipulable arm 400. Fig.13 In the illustrated embodiment, a bend actuation wire 410 that originally extends within the lumen of the sheath 300 is connected to the distal end of the steerable arm 400 .

[0127] It should be noted that the above embodiment does not constitute a limitation on the connection method of the manipulable arm 400 and the bending actuator wire 410, but shows a variety of possible connection methods of the manipulable arm 400 and the bending actuator wire 410. Technical personnel in the relevant field can make flexible choices according to needs under the guidance of the present invention.

[0128] In some specific embodiments, the medical device of the present invention further includes a sheath 405 , which defines a travel path of the actuator actuating wire 510 .

[0129] In some embodiments, the sheath 405 is made of a lubricating material, preferably a resin with a low friction coefficient such as polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF), ethylene-tetrafluoroethylene copolymer (ETFE), ethylene-chlorotrifluoroethylene copolymer (ECTFE), polyvinyl fluoride (PVF), etc. Such a sheath 405 can make the actuator wire 510 pass more smoothly.

[0130] In other embodiments, the sheath 405 is configured as a metal wire spiral tube. The metal wire spiral tube is formed by tightly winding a metal wire in the form of a spiral line, and a hollow pipe is formed inside. This structure has certain elasticity and toughness. In order to make the actuator actuating wire 510 pass more smoothly, the metal wire spiral tube can also be dipped in a lubricating resin. Similarly, a resin with a low friction coefficient can be selected, such as polytetrafluoroethylene (PTFE), polytrifluorochloroethylene (PCTFE), polyvinylidene fluoride (PVDF), ethylene-tetrafluoroethylene copolymer (ETFE), ethylene-chlorotrifluoroethylene copolymer (ECTFE), polyvinyl fluoride (PVF), etc.

[0131] Fig.14 In the illustrated embodiment, the sheath 405 is constructed as a composite structure, including an inner layer 406 made of a lubricating material and an outer layer 407 constructed as a metal wire spiral tube. This structure allows the actuator wire 510 to pass more smoothly and allows the manipulable arm 400 to have a certain degree of elasticity and toughness.

[0132] In certain specific embodiments, such as Figure 3 As shown, the end effector 500 is connected to the first bending portion 512 via a first connecting member 507. Figure 6 As shown, a sleeve structure 508 is constructed at one end of the first connecting member 507, and a small section of the distal end of the first curved portion 512 is inserted into the sleeve structure 508 and fixed, and the fixing method may be welding.

[0133] In some specific embodiments, the medical device of the present invention is further configured with a torque separation member 420 to separate the torque applied to the manipulable arm 400 from the torque applied to the actuator actuating wire 510 .

[0134] In some embodiments, the torque separator 420 is configured as a circular ring, and the torque separator 420 is defined between the inner circumference of the manipulable arm 400 and the outer circumference of the first connecting member 507. Figure 3 As shown, the torque separation member 420 is confined between the inner circumference of the second connecting member 509 and the outer circumference of the sleeve structure 508 of the first connecting member 507. At this time, the annular outer wall and the annular inner wall of the torque separation member 420 can be slidably connected to the inner circumference of the second connecting member 509 and the outer circumference of the sleeve structure 508 respectively.

[0135] In other embodiments, the torque separator 420 is configured as a bearing, and the bearing includes an outer ring and an inner ring, wherein the outer ring and the inner ring are connected to the manipulatable arm 400 and the first connecting member 507 respectively.

[0136] In some specific embodiments, the medical device of the present invention is attached to the outside of the distal end of the endoscope (e.g., the front hard part 150 of the soft endoscope) and is delivered to the treatment site along with the distal end of the endoscope. In order to facilitate the attachment of the medical device to the outside of the distal end of the endoscope, a parallel connection piece 170 needs to be added. Fig.15 and Fig.16 In the illustrated embodiment, one side of the parallel connector 170 is sleeved on the front end hard portion 150 of the soft endoscope, and the other side has an auxiliary channel for the maneuverable arm 400 to pass through and extend.

[0137] It should be noted that the structure of the parallel connection member 170 is not limited to Fig.15 In the embodiment shown, as long as the medical device of the present invention can be bound to the distal end of the endoscope in a suitable manner to form a stable connection relationship, the manipulable arm 400 and the end effector 500 of the medical device can pass through the auxiliary channel provided by the parallel connector 170 and can be manipulated to perform certain inspection and treatment operations. Such a structure is a suitable structure of the parallel connector 170.

[0138] Fig.16 for Fig.15 Schematic diagram of the connection structure of the manipulable arm and the bending actuator wire in the embodiment, the illustrated structure is also another embodiment of the manipulable arm 400, and the manipulable arm 400 is configured as a metal wire spiral tube. The metal wire spiral tube is formed by tightly winding the metal wire in the form of a spiral line, and a hollow pipe is formed inside. The metal wire spiral tube is usually made of a metal material with good biocompatibility, corrosion resistance and mechanical strength, such as stainless steel, titanium alloy, etc.

[0139] In some embodiments, Fig.16 As shown, the proximal end and the distal end of a sheath tube 300 are respectively connected to the manipulator 200 (not shown) and the parallel connector 170, the manipulator arm 400 configured as a wire spiral tube extends in the sheath tube 300, and the bending actuator wire 410 is arranged outside the manipulator arm 400. Here, the sheath tube 300 can be configured as a multi-lumen tube, the manipulator arm 400 and the bending actuator wire 410 respectively pass through different lumens of the multi-lumen tube, and extend to the distal end from different lumens of the multi-lumen tube, and the distal end of the bending actuator wire 410 is finally connected to the distal end of the manipulator arm 400 or the end effector 500.

[0140] The distal end of the manipulable arm 400 extends from the auxiliary channel outlet 171 at the distal end of the parallel connector 170. The mouth of the auxiliary channel outlet 171 provides an anchor point to support the bending of the manipulable arm 400 extending out of the auxiliary channel (detached from the parallel connector 170), so that the manipulable arm 400 and the end effector 500 can obtain a certain position and posture. It should be noted that in order to avoid unnecessary damage to human tissue caused by the end effector 500 during the process of being inserted into the human body, the parallel connector 170 has a space for accommodating the end effector 500. Therefore, the auxiliary channel outlet 171 may be lower than the farthest end of the parallel connector 170 (such as Fig.16 shown).

[0141] In order to achieve the use effect of the present invention, and to minimize the influence of the actuator wire 510 on the flexible bending of the manipulable arm 400, at least one condition can be met: as mentioned above, the first curved portion 512 has a first starting point 514 located at the end of the main body 511, and during the use of the medical device, the first starting point 514 does not cross the anchor point (i.e., the mouth end of the auxiliary channel outlet 171). Furthermore, even when the actuator wire 510 is pushed to the limit position of the preset stroke, the first starting point 514 does not cross the anchor point.

[0142] It should be noted that Figure 2 , Fig.11 , Fig.12 and Fig.13 The illustrated embodiment of the manipulator arm 400 may still be adapted to be attached to the exterior of the distal end of an endoscope (eg, the distal hard portion 150 of a flexible endoscope) via a parallel connection 170 and delivered to a treatment site along with the distal end of the endoscope.

[0143] As another aspect, the present invention further provides a robotic surgery system, which, in addition to the aforementioned remotely manipulable medical instrument, also includes an instrument controller, a user input device, and a control module.

[0144] One or more instrument controllers configured to move and position a medical instrument having an end effector. Each instrument controller includes one or more motors.

[0145] The user input device (eg, one or more hand control devices, one or more foot pedals, one or more buttons on one or more input control devices) is connected to the control module to provide control signals.

[0146] The control module receives control signals from the user input device and switches between multiple operation modes according to these signals, and / or sends control commands to operate one or more instrument controllers.

[0147] The manipulator 200 of the medical device is configured with an interface coupled to the device controller, and the manipulator 200 is controllably connected to the proximal end of the bending actuating wire 410 and the proximal end of the actuator actuating wire 510 .

[0148] When the manipulator 200 is coupled to the interface of the instrument controller, the manipulator 200 can be controlled to manipulate the bending of the manipulatable arm 400 through the bending actuator wire 410, and / or manipulate the end actuator 500 to perform medical operations through the actuator actuator wire 510; when the manipulator 200 is decoupled and separated from the instrument controller, the two no longer operate together.

[0149] Fig.17 and Fig.18 The internal structure of the manipulator 200 (housing not shown) provided by one embodiment of the present invention, wherein the advancement or retreat of the first slider 210 is ultimately manifested as the advancement or retreat of the manipulator arm 400. Figure 2 In the case of, the first slider 210 is connected to the proximal end of the sheath tube 300; when the embodiment is Fig.15 In the case of the above, the manipulator arm 400 is configured as a metal wire spiral tube, and the first slider 210 is connected to the proximal end of the manipulator arm 400, while the proximal end of the sheath tube 300 is connected to the housing of the manipulator 200. The first slider 210 is provided with a first guide hole 211, so that the proximal end of the sheath tube 300 or the proximal end of the manipulator arm 400 in the above different cases can be inserted therein and fixed by a fastener.

[0150] The advancement or retreat of the second slider 220 is ultimately manifested as the advancement or retreat of the actuator actuating wire 510, that is, the second slider 220 is connected to the proximal end of the actuator actuating wire 510. The second slider 220 is provided with a second guide hole 212 for the proximal end of the actuator actuating wire 510 to pass through and be fixed by a fastener.

[0151] The third slider 230 is connected to the proximal end of the bending actuator wire 410, and the advancement or retreat of the third slider 230 is finally manifested as the bending of the manipulable arm 400. The third slider 230 can be replaced by a reel, that is, the movement of the slider is replaced by winding. The reel includes a capstan and its mandrel, and the mandrel is limited on the base 250. The capstan on the mandrel can be a simple cylindrical capstan with a circular cross-section, and the bending actuator wire 410 is wound around the circular cross-section.

[0152] In order to control the position and posture of the manipulator arm 400 and the end effector 500, the trajectory of the slider movement is required to be determined. To this end, a track needs to be set on the base 250 of the manipulator 200 to limit the trajectory of the slider movement. The track can have a variety of different structural forms. In some specific embodiments, such as Fig.17As shown, the track includes three groups of guide rods 261 and guide grooves for guiding the first slider 210 , the second slider 220 , and the third slider 230 respectively, and the first slider 210 and the second slider 220 share one group of guide rods 261 and guide grooves.

[0153] The first slider 210, the second slider 220, and the third slider 230 are respectively provided with third guide holes 213 matching the guide rod 261, and bosses 214 matching the guide grooves. The bosses 214 extend to the bottom of the base 250 through the guide grooves, and the bottom of the bosses 214 (the interface of the manipulator 200) and the interface of the instrument controller are provided with a matching coupling structure, which can be a groove or a protrusion, a hole or a shaft, etc. It can be understood that when the interface of the manipulator 200 is coupled with the interface of the instrument controller, the motor of the instrument controller can drive the manipulator 200.

[0154] It should be noted that the above-mentioned embodiment does not constitute a limitation on the internal structure of the manipulator 200. Under the guidance of the present invention, technicians in the relevant field can make local changes to the structure, position and size of the slider or the reel as needed to achieve the control of the bending actuator wire 410 and / or the actuator actuator wire 510.

[0155] In a specific embodiment in which a torque separation member 420 is provided, the manipulator 200 is further provided with a torque transmission member (not shown), which is fixed to the proximal end of the actuator actuator wire 510. The torque transmission member can be constructed as a gear transmission mechanism, and the instrument controller is provided with a motor that drives the gear transmission mechanism. When the manipulator 200 is coupled to the instrument controller, the manipulator 200 can be controlled to manipulate the actuator actuator wire 510 to rotate around its own axis.

[0156] In some specific embodiments, the robotic surgical system also includes an outer cannula controller configured to move and position the outer cannula (e.g., the outer cannula may be an elongated insertion tube having one or more instrument channels therein for advancing / retracting a medical device therein), and one or more medical devices may extend through the instrument channels of the outer cannula so that the end effector extends from the distal end of the outer cannula.

[0157] For a soft endoscope, the position and posture of the distal end of the endoscope can be controlled manually, that is, by a knob on the operating unit 110; it can also be controlled by a robotic surgery system, for example, by a combination of a hand control device and a foot pedal, or a combination of a hand control device and buttons on the hand control device.

[0158] At this time, the control module can be configured to move the end effector by controlling one or more instrument controllers according to the control signal; the control module can also be configured to move the outer sleeve by controlling the outer sleeve controller according to the control signal, and simultaneously move the camera and end effector mounted thereon.

[0159] The medical device of the present invention arranges the actuator wire in the length direction so that the bending stiffness of the distal small part is smaller than the bending stiffness of the proximal large part. The main body of the proximal large part is responsible for force transmission, and the first bending part of the distal small part can accept a relatively large passive bending. The actuator wire is able to take into account both axial movement performance (pushability) and bending performance (flexibility). That is, under the premise of satisfying the bending effect of the manipulable arm, the end effector can obtain sufficient force and good movement response capability for corresponding inspection and treatment operations.

[0160] In the scenario where the end effector is required to rotate around its own axis, because during the rotation of the wire, if the wire itself is prone to bending and deformation, then this deformation will absorb or disperse part of the rotational energy, causing the rotational response of the end effector to slow down, that is, rotational hysteresis. A wire with high bending stiffness can better maintain its linearity and stability, reduce bending deformation during rotation, and thus transfer rotational energy to the end effector faster, reducing rotational hysteresis. Therefore, the actuator actuating wire provided by the present invention can also obtain better torque transmission performance (torsionability), which provides a better solution for improving the control accuracy and response speed of the end effector carried by the manipulable arm to perform multi-degree-of-freedom motion.

Claims

1. A remotely manipulable medical device, comprising: A manipulable arm, which can be manipulated to be bent, and is configured to have a first inner cavity that runs through the length direction of the manipulable arm; an end effector carried by the manipulable arm, the end effector being operably controlled by an effector actuation wire; Wherein, the actuator actuating wire has a main body portion and a first bending portion along its own length, the first bending portion extends in the first inner cavity of the manipulable arm and is connected to the end actuator, the actuator actuating wire is allowed to be axially advanced and retracted, and the first bending portion is passively bent when the manipulable arm is bent, and the first bending portion has a bending stiffness smaller than that of the main body portion.

2. A distally manipulable medical device, which is delivered to the treatment site through the device channel of the endoscope, and comprises: A manipulable arm, which can be manipulated to be bent, and is configured to have a first inner cavity that runs through the length direction of the manipulable arm; an end effector carried by the manipulable arm, the end effector being operably controlled by an effector actuation wire; Wherein, the actuator actuating wire has a main body portion and a first bending portion along its own length, the first bending portion extends in the first inner cavity of the manipulable arm and is connected to the end actuator, the actuator actuating wire is allowed to be axially advanced and retracted, and the first bending portion is passively bent when the manipulable arm is bent, and the first bending portion has a bending stiffness smaller than that of the main body portion.

3. A distally manipulable medical device, which is attached to the exterior of the distal end of the endoscope via a parallel connection and is delivered to the treatment site along with the endoscope, the medical device comprising: A manipulable arm, which can be manipulated to be bent, and is configured to have a first inner cavity that runs through the length direction of the manipulable arm; an end effector carried by the manipulable arm, the end effector being operably controlled by an effector actuation wire; Wherein, the actuator actuating wire has a main body portion and a first bending portion along its own length, the first bending portion extends in the first inner cavity of the manipulable arm and is connected to the end actuator, the actuator actuating wire is allowed to be axially advanced and retracted, and the first bending portion is passively bent when the manipulable arm is bent, and the first bending portion has a bending stiffness smaller than that of the main body portion.

4. A robotic surgical system using the medical device according to claim 3, wherein the robotic surgical system includes an instrument controller, and the medical device includes a manipulator, wherein the manipulator is configured with an interface coupled to the instrument controller, and when the manipulator is coupled to the instrument controller, the manipulator can be controlled to manipulate the bending of the manipulator arm, and the manipulator can advance or retract the actuator wire; when the manipulator is decoupled and separated from the instrument controller, the two no longer operate together.

5. The robotic surgery system according to claim 4, characterized in that: The manipulator is equipped with a torque transmission member, which is fixed to the proximal end of the actuator wire. When the manipulator is coupled to the instrument controller, the manipulator can be controlled to manipulate the actuator wire to rotate around its own axis.

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