CN119950035A

CN119950035A - Remotely controlled medical devices and robotic surgical systems

Info

Publication number: CN119950035A
Application number: CN202411073124.2A
Authority: CN
Inventors: 田洪东; 皇建
Original assignee: Shenzhen Robo Medical Technology Co ltd
Current assignee: Shenzhen Robo Medical Technology Co ltd
Priority date: 2024-08-06
Filing date: 2024-08-06
Publication date: 2025-05-09

Abstract

A distally steerable medical instrument that combines distal bending capability, end effector performance capability and motion response capability and a robotic surgical system using the instrument are provided. By arranging the actuator wire in the length direction such that the bending stiffness of the distal small portion is smaller than that of the proximal large portion, the proximal large portion of the body portion bears the transmission of force, and the first bending portion of the distal small portion can receive a larger-amplitude passive bending, the actuator wire can achieve both axial movement performance (pushability) and bending performance (flexibility), that is, the end effector can obtain sufficient strength and better movement response capability for performing corresponding examination and treatment operations on the premise of meeting the bending effect of the manipulator arm.

Description

Remotely steerable medical instrument and robotic surgical system

Technical Field

The present invention relates to a distally steerable medical instrument and robotic surgical system.

Background

A distally steerable medical device having a manipulator disposed at a proximal end thereof, the distal end being steerable to bend. It has an actuator wire that can be pushed or pulled to directly control the position and attitude of the end effector, it being readily understood that the change in position of the distal end of the medical device can also result in a change in position of the end effector, when the actuator wire is passively flexed.

A specific example is a medical device for use with a gastroscope. Typically the diameter of the instrument channel of a gastroscope is around 3mm, which requires that the portion of the medical instrument passing through the instrument channel should be no larger than the diameter of the instrument channel, which when the diameter of that portion is 3mm or less, results in a decrease in the deflection moment for manipulating the distal end of the medical instrument, making distal manipulation of such medical instruments difficult. One factor that affects the bending performance of a medical instrument is the bending stiffness of the actuator wire, which is not easily passively bent when the bending stiffness of the actuator wire is large, which affects the steering effect on the distal end of the medical instrument.

Meanwhile, since the medical device has an elongated structure, it is required to maintain the actuation force of the end effector (in particular, the force for achieving the operations of pulling, holding, grasping, etc.), and the response speed, and the actuator wire is required to maintain an effective diameter. Simply reducing the overall diameter of the actuator wire, when a push-pull force is applied to the actuator wire, it is very likely to cause bending of the actuator wire itself, which results in a decrease in the performance of the end effector located at its distal end, and a hysteresis in the movement of the end effector (a decrease in response speed).

Disclosure of Invention

A distally steerable medical instrument that combines distal bending capability, end effector performance capability and motion response capability and a robotic surgical system using the instrument are provided.

A distally steerable medical device, the medical device comprising:

an steerable arm, the steerable arm being steerable to bend, the steerable arm being configured to have a first lumen extending through its length;

An end effector, the manipulator arm carrying the end effector, the end effector being operably controlled by an effector actuation wire;

Wherein the actuator wire has a body portion along its length and a first bend portion extending within the first lumen of the steerable arm and connected to the end effector, the actuator wire being permitted to advance and retract axially, and the first bend portion passively bends when the steerable arm is bent, the first bend portion having a bending stiffness that is less than a bending stiffness of the body portion.

Preferably, the first curved portion has a smaller cross-sectional area than the body portion.

Preferably, the body portion and the first curved portion are integrally constructed by welding, or the first curved portion is obtained by partial grinding of the body portion.

Preferably, the first bend comprises a transition section.

Preferably, the first curved portion has a first origin at the end of the body portion, the first origin being outside the first lumen covered by the steerable arm.

Preferably, the end effector is connected to the first bending part by a first connector, the first connector is configured with a sleeve structure, an outer diameter of a distal end of the first bending part is matched with an inner diameter of the sleeve structure, and the distal end of the first bending part is inserted into the sleeve structure and fixed.

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

Preferably, the steerable arm is formed from a plurality of curved segments connected in series.

Preferably, the said operable arm is formed by cutting at least one time from a metal tube.

Preferably, the medical device further comprises a sheath defining a path of travel of the actuator wire.

Preferably, the sheath is made of a lubricious material.

Preferably, the sheath is configured as a spiral tube of wire.

A distally steerable medical instrument for delivery to a treatment site through an instrument channel of an endoscope, the medical instrument comprising:

Preferably, the first bend comprises a transition section.

Preferably, the medical instrument extends through the instrument channel, and an instrument channel outlet at a distal end of the instrument channel provides an anchor point to support bending of the steerable arm extending out of the instrument channel.

Preferably, the first curved portion has a first origin at an end of the body portion, the first origin not crossing the anchor point during use of the medical device.

Preferably, the medical instrument is provided with a torque separator for separating the torque applied to the steerable arm from the torque applied to the actuator wire.

Preferably, the torque separating member is configured in a circular ring shape, the torque separating member being defined between an inner peripheral surface of the operable arm and an outer peripheral surface of the first connecting member.

Preferably, the torque release element is configured as a bearing comprising an outer ring and an inner ring, which are connected to the operable arm and the first connecting element, respectively.

Preferably, the operable arm is configured as a flexible tube.

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

Preferably, the sheath is made of a lubricious material.

Preferably, the sheath is configured as a spiral tube of wire.

A distally steerable medical instrument attached to an exterior of a distal end of an endoscope by a parallel connection for delivery to a treatment site along with the endoscope, the medical instrument comprising:

Preferably, the first bend comprises a transition section.

Preferably, the medical instrument extends through the parallel connector, the second port portion of the distal end of the parallel connector providing an anchor point to support bending of the steerable arm out of the parallel connector.

Preferably, the operable arm is configured as a flexible tube.

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

Preferably, the sheath is made of a lubricious material.

Preferably, the sheath is configured as a spiral tube of wire.

A robotic surgical system employing the medical instrument described above, the robotic surgical system including an instrument controller, the medical instrument including a manipulator configured with an interface coupled to the instrument controller, the manipulator being controllable to manipulate bending of the steerable arm when the manipulator is coupled to the instrument controller, and the manipulator being advanceable or retractable the actuator actuation wire, the manipulator being decoupled and decoupled from the instrument controller.

Preferably, the manipulator is provided with a torque transmission member secured to a proximal end of the actuator wire, the manipulator being controllable to manipulate the actuator wire in rotation about its own axis when the manipulator is coupled to the instrument controller.

According to the medical instrument, the bending rigidity of the actuator actuating wire is smaller than that of the main part of the near end in the length direction, the main part of the near end bears the transmission of force, the first bending part of the main part of the far end can receive larger-amplitude passive bending, and the actuator actuating wire can achieve both axial movement performance (pushability) and bending performance (flexibility), namely, on the premise of meeting the bending effect of the controllable arm, the end effector can obtain strength and better movement response capability which are enough for corresponding examination and treatment operation.

Drawings

FIG. 1 is a schematic illustration of a connection structure of an actuator wire and an end effector provided in one embodiment of the present invention;

FIG. 2 is a schematic illustration of the coupling of a manipulator arm and an end-effector (bending actuator wires not shown) provided in accordance with one embodiment of the present invention;

FIG. 3 is an exploded view of the distal end of the medical instrument of the embodiment of FIG. 2 (bending actuator wire not shown);

FIG. 4 is a schematic view of the end effector of the embodiment of FIG. 2;

FIG. 5 is a schematic view of the fork connector of the embodiment of FIG. 2;

FIG. 6 is a schematic view of the first connector in the embodiment of FIG. 2;

FIGS. 7 and 8 are partial schematic views of a manipulator arm (actuator wires, bending wires not shown) provided in accordance with one embodiment of the present invention;

FIG. 9 is a schematic diagram of a conventional gastroscope;

FIG. 10 is a schematic view of a medical device according to an embodiment of the present invention;

FIGS. 11, 12 and 13 are schematic views of the attachment of the steerable arm and the bend actuator wire, respectively, in accordance with several embodiments of the present invention;

FIG. 14 is a schematic view of the connection of the steerable arm, sheath and actuator wire (bending actuator wire not shown) provided in one embodiment of the present invention;

FIG. 15 is a schematic view showing a connection structure between a medical device and a conventional gastroscope according to another embodiment of the present invention;

FIG. 16 is a schematic illustration of the attachment of the steerable arm and the bend actuator wire of the embodiment of FIG. 15;

FIGS. 17 and 18 are schematic views showing an internal structure of a manipulator according to an embodiment of the present invention;

FIG. 19 is a schematic view of the first slider in the embodiment of FIG. 17;

fig. 20 is a schematic structural view of a second slider in the embodiment of fig. 17.

Reference numerals referred to are as follows:

The manipulator 110, the insertion 120, the second bend 130, the instrument channel inlet 140, the tip stiffness 150, the instrument channel outlet 160, the parallel link 170, the auxiliary channel outlet 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 steerable arm 400, the first lumen 401, the second lumen 402, the extension 403, the bend section 404, the sheath 405, the inner layer 406, the outer layer 407, the bend actuator wire 410, the torque separator 420, the end effector 500, the first link 501, the second link 502, the first pivot pin 505, the third link 503, the fourth link 504, the second pivot pin 506, the first link 507, the sleeve structure 508, the second link 509, the actuator wire 510, the body portion 511, the first bend 512, the transition 513, the first joint 514, the fork link 521, the tube portion 522, the arm 523.

Detailed Description

It should be noted that, without conflict, the embodiments of the present invention and features of the embodiments may be combined with each other. The invention will be described in detail below with reference to the drawings in connection with embodiments.

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

It should also be noted that, in the description of the present invention, unless explicitly specified and limited otherwise, the terms "connected" and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, or may be directly connected, or may be indirectly connected through an intermediate medium, or may be communication between two members. The specific meaning of the above terms in the present invention can be understood by those skilled in the art according to the specific circumstances.

The medical instrument of the embodiment of the invention is suitable for entering the body through a natural cavity channel or a tiny incision of the human body to perform examination and treatment. The medical device may be used alone or attached to another body device and delivered along with the body device to a treatment site for examination and treatment procedures. The examination and treatment operations described herein may be traction, holding, grasping, suturing, electrocoagulation, cutting, etc.

The medical instrument of the present embodiment includes a manipulator 200, a steerable arm 400, and an end effector 500. Wherein manipulator 200 is used to manipulate bending of steerable arm 400 and manipulation of end effector 500 for examination and treatment. Manipulator 200 may be manual or may be motorized. The manual manipulator 200 is connected to the bending actuator wire 410 and the actuator wire 510, respectively, and provides an operation interface configured as a slide groove and a slide grip, or a wrench, or a knob, provided on the handle. The operator can control the bending of the manipulator arm 400 by pulling and releasing the bending actuator wire 410 through the operation of the operation interface, and can control the operation of checking and treating the end effector 500 by pushing and pulling the actuator wire 510.

The manipulator 200 in the embodiment shown in fig. 10 is suitable for use in a robotic surgical system, and embodiments suitable for use in a robotic surgical system will be further described below.

In the manual manipulator 200 embodiment, the proximal end of the steerable arm 400 is coupled to the sheath 300. Sheath 300 is constructed in a rigid or semi-rigid tubular structure to provide the necessary support and stability. Sheath 300 serves as a channel for delivering an actuation wire or other functional connector, with proximal and distal ends connected to manipulator 200 and steerable arm 400, respectively.

The manipulator arm 400 is configured to be positioned upon actuation of the manipulator 200, and in some embodiments the manipulator arm 400 may include one or more curved segments, which may be a wire-driven continuous body structure.

The manipulator arm 400 carries an end effector 500, the end effector 500 being operably controlled by an effector actuation wire 510. The steerable arm is configured to have a first lumen 401 extending through its length to accommodate an actuator wire 510. In the embodiment shown in fig. 2 and 7, the first cavity 401 is located at a central axis in the longitudinal direction of the steerable arm 400. Although not shown in the figures, it is understood that in the embodiments shown in fig. 2, 11-13, the actuator 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.

The end effector 510 may be a smooth jaw, serrated jaw, gripper, scissors, electrosurgical knife, stapler, needle holder, stapler, or the like.

In the embodiment shown in fig. 4, end effector 510 is a serrated jaw. When the actuator actuates advancement and retraction of the wire 510, the distal clamp will be actuated to open and close, thereby effecting traction/grasping of the body tissue. The end effector as shown in fig. 4 includes a four bar linkage in which a first link 501 and a second link 502 are connected by a first pivot pin 505 and a third link 503 and a fourth link 504 are connected by a second pivot pin 506, the distal end of an actuator wire 510 is connected to the second pivot pin 506, and the first link 501 and the second link 502 extend to form a clamp, respectively.

As shown in fig. 3, the end effector 500 and the steerable arm 400 are connected using a fork link 521 as an intermediary, the fork link 521 including a tube 522 and an arm 523. The tube portion 522 is sleeved and welded to the distal end of the steerable arm 400, the distal end of the actuator wire 510 is connected to the second pivot pin 506 through the tube portion 522, and both ends of the first pivot pin 505 are connected to the arm portions 523, respectively. When the actuator wire 510 is advanced or retracted, the first pivot pin 505 is positioned relatively fixed, while the second pivot pin 506 is moved closer to or farther from the first pivot pin 505, and the distal clamp action will be either open or closed.

In another alternative configuration, the end effector 500 includes a pair of jaws pivotally connected to one another, wherein the effector actuation wire 510 is operably connected to at least one of the pair of jaws, and wherein actuation of the effector actuation wire 510 is configured to pivot the pair of jaws relative to one another.

The actuator wire 510 has a body portion 511 and a first bending portion 512 along its length, and the first bending portion 512 extends in the first lumen 401 of the manipulator arm 400 and is connected to the end effector 500, where the connection may be direct or indirect via an intermediate medium. The actuator wire 510 is allowed to advance and retract axially, and the first bending portion 512 passively bends when the steerable arm 400 bends, the first bending portion 512 having a bending stiffness that is less than the bending stiffness of the body portion 511.

Here, it is desirable that the actuator wire 510 be subjected to axial forces that effectively transmit force to the distal end to actuate the distal end effector 500, while the actuator wire 510 does not provide any more resistance as the steerable arm 400 is flexed. For an elongated actuation wire, a high bending stiffness means that it can maintain its original straight state when subjected to an external force, and bending deformation is not likely to occur. Therefore, the first bending portion 512 has a bending rigidity smaller than that of the body portion 511, the body portion 511 constitutes a large portion in the length direction of the actuator wire 510, which is capable of effectively transmitting the axial force, and the first bending portion 512 constitutes a small portion in the length direction of the actuator wire 510, which is more easily bent passively, and has a small influence on the axial transmission of the force due to its small ratio in the length direction of the actuator wire 510.

The actuator wire 510 is typically a metal wire, and as an example, the actuator wire 510 may be a steel wire or a nitinol wire. In order to obtain the first bending portion 512 having a bending rigidity smaller than that of the body portion 511, the body portion 511 and the first bending portion 512 may be made of different materials, and only the bending rigidity of the first bending portion 512 is required to be smaller than that of the body portion 511.

In certain embodiments, the cross-sectional area of the first curved portion 512 is smaller than the cross-sectional area of the body portion 511, and the smaller cross-sectional area may allow the first curved portion 512 to achieve a smaller bending stiffness. The proportional relationship of the cross-sectional area of the body portion 511 to the cross-sectional area of the first curved portion 512 may take a range of three-quarters to one-third. For example, the diameter of the body portion is 0.5mm, and the diameter of the first curved portion is 0.3mm.

The body portion 511 and the first bent portion 512 may be integrally constructed by welding, and more specifically, the body portion 511 and the first bent portion 512 may be butt-welded together at the ends of two elongated wires by resistance welding. Other welding means that may be employed include pressure welding, friction welding, ultrasonic welding, magnetic welding, laser welding, hot pressure welding, plasma welding, cladding welding, and the like.

In certain embodiments, the first curved portion 512 is obtained by partial rotational grinding of the body portion 511. In the embodiment shown in fig. 1, after partial rotational grinding, a transition 513 with a gradually changing cross-sectional area may be formed between two sections with different cross-sectional areas. The transition section 513 has already begun to have a smaller bending stiffness than the bending stiffness of the body portion 511, so we consider the transition section 513 as part of the first bend 512. For the same reason, we will mark the distal end point of the body portion 511 as the first start point 514, that is, the start point of the first curved portion 512 as the first start point 514.

It should be noted that the "point" of the first start point 514 is a basic element having no size, shape, and dimension, and is used to represent a position. However, in the physical sense, as shown in fig. 1 and 2, the first start point 514 may be an area included in the cross section satisfying the above condition.

To achieve the benefits of the present invention, the presence of the actuator wire 510 has minimal impact on the flexible bending of the steerable arm 400, and preferably the first starting point 514 is located outside the first lumen 401 covered by the steerable arm 400. Further, even when the actuator wire 510 is advanced to the limit of the preset stroke, the first starting point 514 is still located outside the first lumen 401 covered by the steerable arm 400.

Whereas the diameter change (cross-sectional area change) is abrupt in the case where the body portion 511 and the first curved portion 512 are integrally constructed by welding, it is possible to abut with steps. Of course, we still mark the distal end point of the body portion 511 as the first start point 514, i.e. the start point of the first curved portion 512, as the first start point 514.

In certain embodiments, as shown in fig. 3, the end effector 500 is coupled to the first flexure 512 via a first coupling 507. As shown in fig. 6, 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 bending portion 512 is inserted into the sleeve structure 508 and fixed, which may be welded. The other end of the first link 507 is provided with a through hole for the second pivot pin 506 to pass through.

In certain embodiments, the medical device of the present invention may be attached to another body device and delivered to the treatment site along with the body device for examination and treatment procedures. One exemplary embodiment of a body instrument is a medical endoscope.

The medical endoscope is a medical instrument which enters the body through a natural cavity channel or a tiny incision of the human body to perform visual examination and treatment. The endoscope may be a soft endoscope or a hard endoscope.

The main components of the medical endoscope include an outer sleeve and an imaging system. The outer cannula is configured as an elongated insertion tube having an instrument channel for advancement/retraction of other medical instruments.

Taking a soft endoscope as an example, the gastrointestinal endoscope shown in fig. 9 includes, from the near to the far, an operation portion 110, an insertion portion 120, a second bending portion 130, and a distal end hard portion 150. The operation unit 110 is a main area for a doctor to control various operations of the endoscope, and is provided with a plurality of control elements and interfaces for adjusting the posture of the endoscope, performing specific functions, and connecting external devices. The operation section 110 is provided with an instrument channel inlet 140 for inserting various treatment tools such as biopsy forceps, injection needles, etc. for further examination or therapeutic operation under endoscopic guidance. The insertion portion 120 is a main body portion of the endoscope into the inside of the human body. The second bending part 130 is a portion of the distal end of the endoscope that can be flexibly bent according to the manipulation of the user, and in particular, the second bending part 130 is composed of a plurality of movable ring-shaped parts or joints, which can be relatively moved in a preset manner, and this design allows the user to manipulate the bending direction and angle of the second bending part 130 through a lever or an angle knob of the manipulation part 110. The front hard portion 150 is a relatively hard portion that protects the front optical components (e.g., lens assembly) where the light guide window, instrument channel exit are located.

In certain embodiments, the medical device of the present invention may be delivered to a treatment site for examination and treatment procedures within the device channel of an endoscope. The examination and treatment operations described herein may be traction, holding, grasping, suturing, electrocoagulation, cutting, etc.

Attached to the proximal end of the steerable arm 400 is a flexible sheath 300 to accommodate bending operations of the flexible endoscope due to the need to extend through the instrument channel. The distal end of the steerable arm 400 extends from the instrument channel outlet 160 at the distal end of the instrument channel, and the mouth end of the instrument channel outlet 160 provides an anchor point to support the bending of the steerable arm 400 extending out of the instrument channel to achieve a defined position and attitude of the steerable arm 400 and end effector 500.

To achieve the use of the present invention, at least one of the following two conditions may be met to minimize the effect of the presence of the actuator actuation wire 510 on the flexible bending of the steerable arm 400:

First condition, as previously described, the first curved portion 512 has a first start point 514 at the distal end of the body portion 511, and the first start point 514 does not cross the anchor point (i.e., the mouth end of the instrument channel outlet 160) during use of the medical instrument. Further, even when the actuator wire 510 is advanced to the limit of the preset stroke, the first starting point 514 does not cross the anchor point;

In a second condition, the first bending portion 512 has a first starting point 514 located at the end of the body portion 511, and the first starting point 514 is located outside the first inner cavity 401 covered by the operable arm 400, that is, the first starting point 514 does not fall within the range enclosed by the operable arm 400, and the first bending portion 512 falls within the range enclosed by the operable arm 400 for the most part in the length direction. For example, in the embodiment shown in FIG. 2, the L-area shows the area enclosed by the steerable arm 400, the first starting point 514 is outside the L-area, in the embodiment shown in FIGS. 11 and 12, the portion extending distally from the protruding hole 403 is considered to be the steerable arm 400, the first starting point 514 does not fall within the area enclosed by the steerable arm 400, and in the embodiment shown in FIG. 13, the portion extending distally from the most proximal end of the cut in the metal tube is considered to be the steerable arm 400, the first starting point 514 does not fall within the area enclosed by the steerable arm 400. Further, even when the actuator wire 510 is advanced to the limit of the preset stroke, the first start point 514 is located outside the first lumen 401 covered by the steerable arm 400.

In some embodiments, the steerable arm 400 is configured to be actuated to bend by at least one bending actuation wire 410. The bending actuator wire 410 may be disposed within the first lumen 401 (as in the embodiment of fig. 13), may be disposed about the periphery of the steerable arm 400 (as in the embodiments of fig. 11, 12, 16), and may be configured within the body of the steerable arm 400 to provide a second lumen 402 within which the bending actuator wire 410 is disposed (as in the embodiment of fig. 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, and those skilled in the art can flexibly configure the arrangement as required in light of the present invention.

When more bending directions of the steerable arm 400 are desired, the number of bending actuation wires 410 may be increased, such as with two, three, four, six, eight. In this case, the plurality of bending actuator wires 410 may be uniformly distributed or suitably biased in accordance with the intended bending action of the steerable arm 400.

In certain embodiments, the steerable arm 400 is configured as a flexible tube. As previously described, with the medical device of the present embodiment extending through the device passageway, the proximal end of the steerable arm 400 is coupled to a flexible sheath 300 to accommodate bending operations of the flexible endoscope. Here, the steerable arm 400 and the sheath 300 may be of unitary construction. The flexible tubing requires bending during use and the lumen requires passage of an actuation wire or other functional connector, which requires the tubing to provide the necessary support to maintain lumen stability, facilitate introduction and manipulation of the actuation wire or other functional connector, and therefore requires anti-bending capability. In addition, flexible tubing is also required to have resistance to deformation and biocompatibility. For this purpose, the flexible tube may be made of polyurethane (TPU), polytetrafluoroethylene (PTFE), or the like.

The flexible tube may also be a multi-layer braided tube, for example, a Polytetrafluoroethylene (PTFE) material inside the lumen to reduce friction of the lumen to the actuation wire, a middle layer braided of stainless steel material to provide sufficient support to ensure that the sheath is not squeezed to deform as it passes through the instrument channel of the endoscope, affecting the traction of the actuation cord, and an outermost layer of polyether block amide (PEBAX) material to provide support and torsion resistance.

In some embodiments where the manipulator arm 400 is configured as a flexible tube, the manipulator arm 400 is embedded with at least one anchoring ring (not shown), and the bending actuator wire 410 is disposed within the sidewall of the tube and extends axially of the tube. The bending actuator wire 410 is connected to the manipulator 200 and the anchor ring at both ends thereof, respectively, and by operating the manipulator 200, the bending actuator wire 410 can be pulled and the distal tube body (the steerable arm 400) can be bent.

In other embodiments where the steerable arm 400 is configured as a flexible tube, as shown in fig. 11, the distal end of the sheath 300 is provided with an extension hole 403, and a bending actuator wire 410 that would otherwise extend within the lumen of the sheath 300 is threaded through the extension hole 403 and finally the distal end thereof is connected to the distal end of the steerable arm 400.

In certain embodiments, the steerable arm 400 is formed from a plurality of curved segments 404 in series. The curved section 404 may have a variety of different configurations, and the curved section 404 may be annular or block-shaped (as shown in fig. 2). The bending sections 404 may be hinged or may be a sliding connection between the protrusions and the recesses (bending sections 404 are two-by-two and capable of angular relative movement).

In the embodiment shown in fig. 7 and 8, the first lumen 401 and the second lumen 402 are configured on the steerable arm 400 to provide a path for the actuator wire 510 and the bend actuator wire 410, respectively, to travel therethrough. It should be noted that in the embodiment shown in fig. 8, 6 second lumens 402 are configured in total, and only 3 second lumens 402 are shown with dashed lines for simplicity. It will be appreciated that the through holes provided in each bending section 404 may form a first lumen 401 and a second lumen 402 for delivering actuation wires. In the embodiment shown in fig. 7 and 8, only 4 curved segments 404 are shown. The bending section 404 has an inclined surface so as to be able to constitute the steerable arm 400 that is bent over a certain range.

In some embodiments, the steerable arm 400 is formed from at least one cut made in a metal tube. The cutting mode can be transverse cutting, oblique cutting or spiral cutting, and the material of the metal tube can be memory alloy. In the embodiment shown in fig. 12, the distal end of the sheath 300 is provided with an extension hole 403, and a bending actuator wire 410, which extends in the lumen of the sheath 300, is passed through the extension hole 403, and finally the distal end thereof is connected to the distal end of the steerable arm 400. While in the embodiment shown in fig. 13, a bending actuator wire 410, which would otherwise extend within the lumen of the sheath 300, is connected to the distal end of the steerable arm 400.

It should be noted that the above embodiments do not limit the connection manner of the steerable arm 400 and the bending actuator wire 410, but illustrate various possible connection manners of the steerable arm 400 and the bending actuator wire 410, and those skilled in the art can flexibly select the connection manner according to the needs in the light of the present invention.

In certain embodiments, the medical device of the present invention further comprises a sheath 405, the sheath 405 defining a path of travel for the actuator wire 510.

In some embodiments, the sheath 405 is made of a lubricious material, preferably a low coefficient of friction resin such as Polytetrafluoroethylene (PTFE), poly (chlorotrifluoroethylene) (PCTFE), polyvinylidene fluoride (PVDF), ethylene-tetrafluoroethylene copolymer (ETFE), ethylene-chlorotrifluoroethylene copolymer (ECTFE), polyvinyl fluoride (PVF), and the like. Such a sheath 405 may provide for a smoother passage of the actuator wire 510.

In other embodiments, the sheath 405 is configured as a coiled wire tube. The metal wire spiral tube is formed by tightly winding metal wires in a spiral line mode, a hollow pipeline is formed inside the metal wire spiral tube, and the structure has certain elasticity and toughness. To facilitate the smooth passage of the actuator wire 510, the wire coil may also be dip coated with a lubricious resin, again, optionally a low coefficient of friction resin such as Polytetrafluoroethylene (PTFE), polytrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF), ethylene-tetrafluoroethylene copolymer (ETFE), ethylene-chlorotrifluoroethylene copolymer (ECTFE), polyvinyl fluoride (PVF), and the like.

In the embodiment shown in fig. 14, the sheath 405 is constructed as a composite structure, i.e. comprising an inner layer 406 made of a lubricious material, and an outer layer 407 constructed as a spiral tube of wire. This configuration provides for smoother travel of the actuator wire 510 while providing some flexibility and toughness to the steerable arm 400.

In certain embodiments, as shown in fig. 3, the end effector 500 is coupled to the first flexure 512 via a first coupling 507. As shown in fig. 6, 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 bending portion 512 is inserted into the sleeve structure 508 and fixed, which may be welded.

In certain embodiments, the medical device of the present invention is further configured with a torque separator 420 to separate the torque experienced by the steerable arm 400 from the torque experienced by the actuator wire 510.

In some embodiments, the torque split member 420 is configured as an annular ring, the torque split member 420 being defined between an inner circumferential surface of the operable arm 400 and an outer circumferential surface of the first link 507. As shown in fig. 3, the torque separator 420 is defined between the inner circumferential surface of the second coupling member 509 and the outer circumferential surface of the sleeve structure 508 of the first coupling member 507, and at this time, the outer and inner annular walls of the torque separator 420 may be slidably coupled with the inner circumferential surface of the second coupling member 509 and the outer circumferential surface of the sleeve structure 508, respectively.

In other embodiments, the torque separator 420 is configured as a bearing comprising an outer race and an inner race that are coupled to the steerable arm 400 and the first connector 507, respectively.

In certain embodiments, the medical device of the present invention is attached to the exterior of the distal end of an endoscope (e.g., the distal hard portion 150 of a flexible endoscope), along with the distal end of the endoscope, for delivery to a treatment site. To facilitate attachment of the medical device to the exterior of the distal end of the endoscope, a parallel connector 170 is added. In the embodiment of fig. 15 and 16, one side of the parallel link 170 is sleeved on the hard portion 150 of the distal end of the flexible endoscope, and the other side has an auxiliary channel through which the steerable arm 400 extends.

It should be noted that the structure of the parallel connector 170 is not limited to the embodiment shown in fig. 15, and such a structure is a suitable structure of the parallel connector 170, 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, and the manipulator 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 a certain examination and treatment operation.

Fig. 16 is a schematic view of the connection between the steerable arm and the bend actuator wire of the embodiment of fig. 15, and is a further embodiment of the steerable arm 400. The steerable arm 400 is configured as a coiled wire tube. The metal wire spiral tube is formed by tightly winding metal wires in a spiral line mode, and a hollow pipeline is formed inside the metal wire spiral tube. The wire spiral tube is generally made of a metal material having good biocompatibility, corrosion resistance and mechanical strength, such as stainless steel, titanium alloy, etc.

In some embodiments, as shown in fig. 16, a sheath 300 has a proximal end and a distal end connected to the manipulator 200 (not shown) and the parallel connector 170, respectively, and a steerable arm 400 configured as a coiled wire tube extends within the sheath 300, with the curved actuation wire 410 disposed outside of the steerable arm 400. Here, the sheath 300 may be configured as a multi-lumen tube, with the steerable arm 400 and the bending actuator wire 410 passing through and extending distally from different lumens of the multi-lumen tube, respectively, with the distal end of the bending actuator wire 410 ultimately being connected to the distal end of the steerable arm 400 or the end effector 500.

The distal end of the steerable arm 400 extends from the auxiliary channel outlet 171 at the distal end of the parallel link 170, and the mouth end of the auxiliary channel outlet 171 provides an anchor point to support the bending of the steerable arm 400 extending out of the auxiliary channel (out of the parallel link 170) to achieve a defined position and attitude of the steerable arm 400 and end effector 500. It should be noted that, to avoid unnecessary damage to the human tissue caused by the end effector 500 during the feeding into the human body, the parallel link 170 is configured to have a space for accommodating the end effector 500, and thus, the auxiliary channel outlet 171 may be lower than the most distal end of the parallel link 170 (as shown in fig. 16).

To achieve the benefits of the present invention, at least one condition may be met in which the presence of the actuator wire 510 has minimal impact on the flexible bending of the steerable arm 400, as previously described, the first bending portion 512 has a first start point 514 at the distal end of the body portion 511, and the first start point 514 does not cross the anchor point (i.e., the mouth end of the auxiliary channel outlet 171) during use of the medical device. Further, even when the actuator wire 510 is advanced to the limit of the preset stroke, the first starting point 514 does not cross the anchor point.

It should be noted that the embodiment of the steerable arm 400 illustrated in fig. 2, 11, 12 and 13 may still be adapted for attachment to the exterior of the distal end of an endoscope (e.g., the distal hard portion 150 of a flexible endoscope) via the parallel connection 170, along with the distal end of the endoscope for delivery to a treatment site.

As another aspect, the present invention also provides a robotic surgical system that includes an instrument controller, a user input device, and a control module in addition to the aforementioned distally steerable medical instrument. Wherein,

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.

A user input device (e.g., one or more hand controls, one or more foot pedals, one or more buttons on one or more input control devices) is coupled to the control module to provide control signals.

The control module receives control signals from the user input device and switches between a plurality of modes of operation and/or transmits control commands to operate one or more instrument controllers based on the signals.

The manipulator 200 of the medical instrument is configured with an interface coupled to the instrument controller, the manipulator 200 being operably connected to the proximal end of the bending actuator wire 410 and the proximal end of the effector actuator wire 510, respectively.

When manipulator 200 is coupled to an interface of an instrument controller, manipulator 200 may be controlled to manipulate bending of steerable arm 400 via bending actuation wire 410 and/or end effector 500 via actuator wire 510 to perform a medical procedure, and when manipulator 200 is decoupled and decoupled from the instrument controller, the two are no longer operated together.

Fig. 17 and 18 illustrate an internal structure (not shown) of the manipulator 200 according to an embodiment of the present invention, wherein the pushing or retracting of the first slider 210 is finally represented as the advancing or retracting of the manipulator arm 400. When the embodiment is the case of fig. 2, the first slider 210 is connected to the proximal end of the sheath 300, and when the embodiment is the case of fig. 15, the steerable arm 400 is configured as a coiled wire, the first slider 210 being connected to the proximal end of the steerable arm 400 and the proximal end of the sheath 300 being connected to the housing of the manipulator 200. The first slider 210 is provided with a first guide hole 211 through which the proximal end of the sheath 300 or the proximal end of the operable arm 400 is inserted and fastened by a fastener.

Advancement or retraction of the second slider 220 ultimately translates into advancement or retraction of the actuator wire 510, that is, the second slider 220 is coupled to the proximal end of the actuator wire 510. The second slider 220 is provided with a second guide hole 212 for the proximal end of the actuator wire 510 to pass therethrough and be secured with a fastener.

The third slider 230 is connected to the proximal end of the bending actuator wire 410, and advancement or retraction of the third slider 230 ultimately translates into bending of the steerable arm 400. The third slider 230 may be replaced with a reel, i.e. replace the movement of the slider in a winding manner. The spool includes a capstan and its spindle, which is retained on a base 250. The capstan on the mandrel may be a simple cylindrical capstan having a circular cross-section around which the bend actuator wire 410 is wrapped.

To allow the position and attitude of the manipulator arm 400 and end-effector 500 to be controlled, a track of the slider movement is required, for which a track may be provided on the base 250 of the manipulator 200 to define the track of the slider movement, and may take a variety of different configurations. In some embodiments, as shown in fig. 17, the track includes three sets of guide bars 261 and guide grooves that guide the first slider 210, the second slider 220, and the third slider 230, respectively, the first slider 210 and the second slider 220 sharing one set of guide bars 261 and guide grooves.

The first slider 210, the second slider 220, and the third slider 230 are respectively provided with third guide holes 213 matching with the guide rods 261, and bosses 214 matching with the guide grooves. The boss 214 protrudes through the guide slot toward the bottom of the base 250, and the bottom of the boss 214 (the interface of the manipulator 200) and the interface of the instrument controller are provided with coupling structures that mate with each other, which may be grooves or protrusions, holes or shafts, etc. It will be appreciated that when the interface of the manipulator 200 is coupled with the interface of the instrument controller, the motor of the instrument controller is able to drive the manipulator 200.

It should be noted that the above embodiments do not limit the internal structure of the manipulator 200, and those skilled in the art may modify the structure, position and size of the slider or the reel locally as needed to implement the manipulation of the bending actuator wire 410 and/or the actuator wire 510 in light of the present disclosure.

In the particular embodiment provided with torque separator 420, manipulator 200 is further configured with a torque transfer member (not shown) secured to the proximal end of actuator wire 510, which may be configured as a gear train, and the instrument controller is configured with a motor that drives the gear train, and manipulator 200 may controllably manipulate actuator wire 510 for rotation about its own axis when manipulator 200 is coupled to the instrument controller.

In some embodiments, the robotic surgical system further includes an overtube controller configured to move and position the overtube (e.g., the overtube may be an elongate insertion tube having one or more instrument channels therein for advancement/retraction of medical instruments therein), the one or more medical instruments extendable through the instrument channels of the overtube such that the end effector extends from a distal end of the overtube.

The position and posture of the distal end of the flexible endoscope can be controlled manually, i.e., by a knob on the operating portion 110, or by a robotic surgical system, e.g., by a combination of a hand control and a foot pedal, or by a combination of a hand control and a button on a hand control.

In this case, the control module may be configured to move the end effector by controlling one or more instrument controllers in accordance with the control signals, and the control module may be further configured to move the outer cannula by controlling the outer cannula controller in accordance with the control signals while moving the camera and the end effector mounted thereon.

In the case where the end effector is required to spin around its own axis, if the wire itself is easily bent and deformed during the rotation of the wire, such deformation absorbs or disperses a part of the rotational energy, resulting in a slow rotational response of the end effector, that is, a rotational lag. The metal wire with high bending rigidity can better maintain the linearity and stability, and reduce bending deformation in the rotating process, so that the rotating energy is more quickly transmitted to the end effector, and the rotating hysteresis is reduced. Therefore, the actuator actuating wire provided by the invention can also obtain better torque transmission performance (torsionality), and provides a better solution for improving the control precision and response speed of operating the end effector carried by the operable arm to perform multi-degree-of-freedom motion.

Claims

1. A distally steerable medical device, the medical device comprising:

2. A distally steerable medical instrument for delivery to a treatment site through an instrument channel of an endoscope, the medical instrument comprising:

3. A distally steerable medical instrument attached to an exterior of a distal end of an endoscope by a parallel connection for delivery to a treatment site along with the endoscope, the medical instrument comprising:

4. A robotic surgical system employing the medical instrument of claim 3, the robotic surgical system comprising an instrument controller, the medical instrument comprising a manipulator configured with an interface coupled to the instrument controller, the manipulator being controllable to manipulate bending of the steerable arm when the manipulator is coupled to the instrument controller, and the manipulator being advanceable or retractable the actuator actuation wire, the manipulator being decoupled and decoupled from the instrument controller and no longer operating together.

5. The robotic surgical system of claim 4, wherein the manipulator is configured with a torque transfer member secured to a proximal end of the actuator wire, the manipulator being controllable to manipulate the actuator wire to rotate about its own axis when the manipulator is coupled to the instrument controller.