Transurethral resection apparatus, systems, and methods of use thereof
Patent Information
- Application Number
- CN202480088838.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2024-01-04
- Filing Date
- 2024-12-09
- Publication Date
- 2026-09-22
AI Technical Summary
然而,使用当前设备整块(较大尺寸)移除癌组织可能导致切除过深,引起膀胱壁穿孔
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Figure CN122803813A_ABST
Abstract
Description
Cross-references to related applications
[0001] This application claims priority to Singapore application No. 10202400034R, filed on 4 January 2024, the entire contents of which are incorporated herein by reference for all purposes. Technical Field
[0002] This application relates to a medical device for use in urology, and more specifically, to a transurethral resection device, a transurethral resection system, and a method of using the device and system. Background Technology
[0003] Transurethral resection of bladder tumors or bladder tissue (TURBT) typically involves the removal of non-muscle-invasive bladder cancer (NMIBC). Although TURBT is routinely performed minimally invasively using a resection endoscope equipped with a rigid endoscope and electrocautery tools, the recurrence rate of bladder cancer after TURBT exceeds 60%. This high recurrence rate is believed to be partly due to incomplete removal of the cancerous tissue, as bladder tumors are often removed in pieces. However, removing cancerous tissue en bloc (larger size) using current equipment can lead to excessively deep resections, causing bladder wall perforation. Summary of the Invention
[0004] According to one aspect, a transurethral resection device is disclosed herein. The transurethral resection device may include: a housing defining a channel extending in an axial direction; a gripper assembly disposed in the channel, the gripper assembly being axially movable relative to the channel, the gripper assembly including: a gripper defining an end of the gripper assembly; a first elongated body defining a gripper body axis parallel to the axial direction; and a first continuous joint coupled between the first elongated body and the gripper, the first continuous joint being actuated to displace the gripper relative to the first elongated body; and a cutter assembly disposed in the channel, the cutter assembly being axially movable relative to the channel, the cutter assembly including: a cutter defining an end of the cutter assembly; a second elongated body defining a cutter body axis parallel to the axial direction; and a second continuous joint coupled between the second elongated body and the cutter, the second continuous joint being actuated to displace the cutter relative to the second elongated body, wherein the first continuous joint and the second continuous joint can be actuated independently of each other.
[0005] According to another aspect, this document discloses a transurethral resection system. The transurethral resection system includes: an irrigation sheath defining a device channel, the irrigation sheath including an irrigation inlet path and an irrigation outlet path; and a transurethral resection device as described above, the transurethral resection device being fluid-tightly coupled to the device channel.
[0006] In another aspect, this document discloses a method for operating the transurethral resection device as described above. The method includes: grasping a target portion disposed on a target surface with a grasper; moving the grasper away from the target surface along a grasper plane while holding the target portion in place with the grasper; and moving a cutter in a cutter plane to cut between the target portion and the target surface, wherein the cutter plane is orthogonal to the grasper plane. Attached Figure Description
[0007] Various embodiments of this disclosure are described with reference to the following figures:
[0008] Figure 1 This is a schematic diagram of a transurethral resection system according to an embodiment of the present disclosure;
[0009] Figure 2 This is a schematic diagram of a transurethral resection system and transurethral resection device according to various embodiments, used during a transurethral surgery.
[0010] Figure 3 Schematic diagrams of transurethral resection systems according to various embodiments are shown;
[0011] Figures 4A to 4D The procedure for transurethral surgery according to various embodiments is shown;
[0012] Figure 5 A perspective view and a detailed view of a transurethral resection device according to various embodiments are shown (View A);
[0013] Figure 6 Various embodiments are shown. Figure 5 Perspective and detail view of the transurethral resection device coupled to the irrigation sheath (View B).
[0014] Figure 7 Showing Figure 6 Partial side view;
[0015] Figure 8 A perspective view and a detailed view (view C) are shown of a transurethral resection device guided to an irrigation sheath according to various embodiments;
[0016] Figure 9 Showing Figure 8 The front view;
[0017] Figure 10 Showing Figure 8 Partial cross-sectional view;
[0018] Figure 11 A perspective view of a gripper assembly according to various embodiments is shown;
[0019] Figure 12 yes Figure 11Exploded view;
[0020] Figure 13 A perspective view of a cutter assembly according to various embodiments is shown;
[0021] Figure 14 yes Figure 13 Exploded view;
[0022] Figures 15A to 15C Exemplary ends of a cutter according to various embodiments are shown;
[0023] Figure 16 and Figure 17 A perspective view of a continuum joint according to various embodiments is shown;
[0024] Figure 18 A perspective view of a disc of a continuum joint according to various embodiments is shown;
[0025] Figure 19 yes Figure 18 Top view;
[0026] Figure 20 yes Figure 18 Side view (view D);
[0027] Figure 21 yes Figure 18 Side view (view E);
[0028] Figure 22A and Figure 22B The rotation of a disk relative to an adjacent disk is shown according to various embodiments;
[0029] Figures 23A to 23D A perspective view showing a method of operating a transurethral resection system and transurethral resection device according to various embodiments;
[0030] Figure 24 yes Figure 23C Side view;
[0031] Figure 25 This is a flowchart of the method for operating a transurethral resection device;
[0032] Figure 26A This is a schematic diagram of the ROBERT system in an exemplary embodiment;
[0033] Figure 26B The ROBERT system and experimental setup in the operating room were shown;
[0034] Figure 26C The flushing connection on the flushing sheath is shown;
[0035] Figure 26D Showing Figure 26AThe distal end of the resection scope;
[0036] Figure 27A The assembly process of the robotic resection scope is shown;
[0037] Figure 27B The assembled robotic resection scope is shown;
[0038] Figure 27C The various degrees of freedom (DOF) of the robotic resection scope are shown.
[0039] Figure 27D The tendons of the wrist are shown;
[0040] Figure 27E The movement of the chordae tendineae as observed along the x-axis, along with the corresponding yaw and pitch movements, is shown.
[0041] Figure 27F This is a schematic diagram of the tendineae route inside the gripper and its actuation via TSM;
[0042] Figure 27G The complete assembly of the instrument, motor housing, and linear actuator is shown;
[0043] Figure 28A Shown in Local coordinate system (LC) in a plane;
[0044] Figure 28B Shown in Local coordinate system in a plane;
[0045] Figure 28C Shown in Geometric relationships and displacements of the contact line in a plane;
[0046] Figure 28D Shown in Geometric relationships and displacements of the contact line in a plane;
[0047] Figure 28E Showing when The working space of the gripper and cutter;
[0048] Figure 28F Showing when The working space of the gripper and cutter;
[0049] Figure 29A An experimental setup for tracking motion at the end effector of a gripper is shown;
[0050] Figure 29B This is a schematic diagram for measuring the wrist angle during yaw and pitch movements;
[0051] Figure 29CAn isometric view showing the estimated workspace and experimental results;
[0052] Figure 29D Showing Figure 29C Detail view of the dashed box;
[0053] Figure 29E The average displacement error at 25 locations in the workspace is displayed;
[0054] Figure 29F The standard deviation (STD) values are displayed at 25 locations in the workspace;
[0055] Figures 30A to 30D The apparatus and results of the force measurement are shown. Figure 30A The device for force measurement is shown. Figure 30B This is a schematic diagram of wrist strength measurement. Figure 30C This is a schematic diagram of gripping force measurement. Figure 30D The average wrist force of G3 at different wrist angles is shown;
[0056] Figures 31A to 31H An in vitro experimental setup using a pig bladder is shown. Figure 31A An in vitro experimental setup using a pig bladder is shown. Figure 31B It shows the location where the target tissue was cut. Figures 31C to 31E This is an endoscopic view of a block resection performed on the posterior wall, top, and anterior neck. Figures 31D to 31H These are images of excised tissue from the posterior wall, top, and anterior neck;
[0057] Figure 32A and Figure 32B This is an endoscopic view of a posterior wall en bloc resection.
[0058] Figure 32C The resected tissue from the posterior wall is shown;
[0059] Figure 32D and Figure 32E This is an endoscopic view of a block resection performed on the anterior wall;
[0060] Figure 32F It is an image of the excised tissue from the anterior wall;
[0061] Figure 33 The components of a resection scope according to various embodiments are shown;
[0062] Figure 34 The components of the flushing sheath assembly according to various embodiments are shown;
[0063] Figure 35 An exploded view of the resection device according to various embodiments is shown;
[0064] Figures 36A to 36D The illustration shows various disks with curved top and bottom surfaces, as well as continuous arms with these disks. Figure 36A This is a horizontal view (viewed from above) of the yaw (left-right) degree of freedom. and Forming a symmetrical and convex curve that describes the top curved surface. Figure 36B It shows asymmetrical curves, for example. and . Figure 36C It shows a symmetrical curve with constant curvature, for example... . Figure 36D The diagram shows a symmetrical curve with varying curvature, such as a parabola. Similarly, the bottom surface is defined by a concave curve. Detailed Implementation
[0065] The following detailed description refers to the accompanying drawings, which illustrate details and embodiments of this disclosure for illustrative purposes. Features described in the context of these embodiments may be appropriately applied to the same or similar features in other embodiments, even if not explicitly described in those other embodiments. Additions and / or combinations and / or alternatives to features described in the context of these embodiments may be appropriately applied to the same or similar features in other embodiments.
[0066] In the context of various embodiments, an undefined number of features or elements includes references to one or more features or elements.
[0067] In the context of various embodiments, the term “about” or “approximately” applied to numerical values covers the exact value as well as a reasonable variance as generally understood in the relevant art, such as within 10% of the specified value.
[0068] As used herein, the term “and / or” includes any and all combinations of one or more of the related listed items.
[0069] The term "pose" can include the position and orientation of an object or part of an object. The term "position" can refer to the location or coordinates (e.g., X coordinate, Y coordinate, Z coordinate) of an object or part of an object in space or a frame. The term "orientation" can refer to the orientation or angle (e.g., X direction vector, Y direction vector, Z direction vector) of an object or part of an object in space or a frame.
[0070] The term "channel" can refer to an elongated space extending along an axis in a structure. A "channel" can have a regular cross-section along the axis. Alternatively, a channel can have an irregular cross-section along the axis. A "channel" can also include multiple sub-channels, each defining a separate elongated subspace.
[0071] As used herein, the term "transurethral" generally refers to medical procedures performed through the urethra or medical devices that can be used through the urethra. In some examples, it can refer to procedures performed through specialized instruments inserted into the urethra.
[0072] This disclosure discloses a transurethral resection device and a transurethral resection system according to various embodiments. The transurethral resection device can be an elongated device. The transurethral resection device can be a miniature device suitable for transurethral procedures.
[0073] In various embodiments, the transurethral resection device may include a plurality of end effectors, each movable relative to a reference (e.g., a housing or a guide member for the end effector). Each end effector may be configured to perform a specific function. In some embodiments, the end effector may include a gripper and a cutter.
[0074] In the proposed transurethral resection procedure, the grasper holds and lifts the target tissue portion located on the target surface of the bladder. Subsequently, the cutter moves toward the neck or connecting portion between the target tissue portion and the target surface and severs the target tissue portion. In some embodiments, the neck or connecting portion may not be a narrowing structure; therefore, the cutter can move along a sweeping path to cut the connecting portion, typically through cyclic or periodic movements.
[0075] In various embodiments, the gripper is displaceable to move in a gripper plane, and the cutter is displaceable to move in a cutter plane, wherein the cutter plane is orthogonal to the gripper plane. Therefore, the gripper is typically movable in a plane orthogonal to the cutter plane, and the cutter is typically movable in a plane orthogonal to the gripper plane.
[0076] In various embodiments, the gripper may be configured to have a large range of motion (or a large angular displacement range), while the cutter may be configured to have a relatively small range of motion (or a limited angular displacement range). Therefore, the movement of the cutter can be restricted according to the requirements of a specific medical procedure. Restricting the movement of the cutter reduces the risk of accidentally cutting or puncturing tissue near the connecting portion. Furthermore, the larger range of motion of the gripper allows for holding the target tissue portion and lifting it away from the target surface.
[0077] In various embodiments, to implement the transurethral resection procedure described above, each end effector may be provided with its own continuum joint. In various embodiments, the pose (including position and orientation) of the gripper can be changed by actuating the corresponding continuum joint. Similarly, the pose (including position and orientation) of the cutter can also be changed by actuating the corresponding continuum joint. In various embodiments, the continuum joint can bend about two orthogonal axes. In the example, the corresponding continuum joint allows the pitch and yaw angles of each of the gripper and cutter to be controllably changed. In various embodiments, each of the gripper and cutter may have 3 degrees of freedom (DOF). In various embodiments, each of the gripper and cutter may have 5 degrees of freedom.
[0078] In various embodiments, an endoscope is available during the transurethral resection procedure. Unlike other medical procedures where an unobstructed endoscopic view is preferred, the proposed transurethral resection device can be configured such that the end effectors (i.e., the grasper and cutter) are always within the endoscopic field of view. This allows the operator (e.g., a physician) to have a more complete view of the lifting and cutting process as described above.
[0079] Figure 1 The illustration shows a transurethral resection system 50 according to various embodiments of the present disclosure. The transurethral resection system 50 may include a transurethral resection device 100 that communicates with a controller 500. The controller 500 may be configured to control and actuate the transurethral resection device 100.
[0080] The transurethral resection device 100 may include a housing 110 defining a channel 112. In an exemplary embodiment, the housing 110 defines a maximum diameter of 7 mm. The channel 112 may extend in an axial direction 114. A gripper assembly 200 may be disposed in the channel 112. The gripper assembly 200 is movable or extendable / retractable relative to the channel 112 in the axial direction 114. Furthermore, a cutter assembly 300 may be disposed in the channel 112. The cutter assembly 300 is movable or extendable / retractable relative to the channel 112 in the axial direction 114.
[0081] In various embodiments, the gripper assembly 200 may include a gripper 210 defining an end portion of the gripper assembly 200. The gripper 210 may be configured in various forms, such as a jaw gripper (e.g., a jaw gripper). Figure 1(As shown), coagulation grippers, electrocautery forceps, snares, rings, etc. The gripper assembly 200 may further include a first elongated body 220 defining a gripper body axis 222; and a first joint or first continuous joint 230 coupled between the first elongated body 220 and the gripper 210. The gripper body axis 222 may be parallel to the axial direction 114. The first continuous joint 230 may be actuated to displace the gripper 210 relative to the first elongated body 220.
[0082] In various embodiments, the cutter assembly 300 may include a cutter 310 that defines an end of the cutter assembly 300. The cutter 310 may be configured in various forms, such as an electrocautery cutter (e.g.,...). Figure 1 (As shown), ultrasonic scalpels, electrocautery forceps, surgical laser devices, scissors, etc. The cutter assembly 300 may further include a second elongated body 320 defining a cutter body axis 322; and a second joint or second continuous joint 330 coupled between the second elongated body 320 and the cutter 310. The cutter body axis 322 may be parallel to the axial direction 114. The second continuous joint 330 may be actuated to displace the cutter 310 relative to the second elongated body 320.
[0083] In various embodiments, the gripper 210 and the cutter 310 may be configured as similar or identical tools. For example, both the gripper 210 and the cutter 310 may be configured as corresponding electrocautery forceps. This provides "tool symmetry," allowing the gripper 210 to include the functionality of a cutter, while the cutter 310 may include the functionality of a gripper. With this tool symmetry, the transurethral resection device 100 is suitable for both right-handed and left-handed users. Furthermore, see reference... Figure 1 In various embodiments, the relative positions of the gripper assembly 200 and the cutter assembly 300 can be interchanged according to user preference. Therefore, this allows the transurethral resection device 100 to be customized to user requirements.
[0084] In various embodiments, the first continuous joint 230 and the second continuous joint 330 may be actuated by an actuator 550 that communicates with the controller 500. In various embodiments, the first continuous joint 230 and the second continuous joint 330 may be actuated independently of each other by the actuator 550.
[0085] The gripper assembly 200 can be actuated to change a first pose of the gripper 210, wherein the first pose includes a first orientation and a first position of the gripper 210 relative to the housing 110. Similarly, the cutter assembly 300 can be actuated to change a second pose of the cutter 310, wherein the second pose includes a second orientation and a second position of the cutter 310 relative to the housing 110.
[0086] In various embodiments, the transurethral resection device 100 may further include an endoscope 140 disposed in the channel 112. The endoscope 140 may be positioned adjacent to the grasper assembly 200 and the cutter assembly 300.
[0087] Figure 2 This is a schematic diagram of the transurethral resection system 50 and transurethral resection device 100 used during a transurethral surgery. The transurethral resection system 50 is operable to remove a target portion 92 (or target tissue portion) from a target surface 91 of the bladder 90.
[0088] According to such Figure 3 In the various embodiments shown, the transurethral resection system 50 may further include a user interface 510 that communicates signalically with the controller 500. The user interface 510 may include user input 520 configured to receive control commands from a user. Furthermore, the user interface 510 may include a display 530 for displaying a view of the endoscope 140 to the user. Figure 3 As shown, in various embodiments, the gripper 210 and the cutter 310 may be positioned within the field of view of the endoscope 140.
[0089] Figures 4A to 4D The method of operating the transurethral resection system 50 and the transurethral resection device 100 for non-muscle-invasive bladder cancer is illustrated schematically. The bladder wall comprises multiple layers, arranged from the innermost to the outermost layer: the lining layer, the submucosa, the muscle layer, and the fat layer. Given that the fat layer is easily perforated by cutting instruments (such as diathermy tools), the resection operation must be performed carefully within the muscle layer to avoid penetration. The procedure for en bloc bladder tumor resection is as follows. (Reference) Figure 4A An irrigation sheath with an obturator is introduced into the bladder via the urethra. The obturator is then removed, and the transurethral resection device is inserted. In various embodiments, the angle of attack for resection can be adjusted accordingly by changing the orientation and position of the irrigation sheath. Bladder volume can be adjusted by controlling the flow rate of the irrigation sheath, thereby fine-tuning the surgical site. See below for further details. Figure 4B The gripper can be used to move the bladder tumor (target portion) and lift it away from the target surface to expose the connecting portion or base. (Reference) Figure 4CA cutting tool (such as a diathermy tool) can be used to cut or remove bladder tumors. To minimize the risk of residual cancer tissue, the resection procedure can be performed with negative surgical margins. The orientation and position of the transurethral resection device / irrigation sheath can be adjusted when the surgeon's vision is obstructed or the depth of cut at the current location cannot be ensured. The cutting procedure can be repeated to remove the bladder tumor en bloc, such as... Figure 4D As shown.
[0090] Figure 5 The illustration shows a transurethral resection device 100 according to various embodiments of the present disclosure. The transurethral resection device 100 may include a housing 110 defining a channel having a plurality of sub-channels 112a / 112b / 112c. The channel and sub-channels 112a / 112b / 112c may extend in an axial direction 114. Figure 5 As shown, a gripper assembly 200 may be disposed in subchannel 112a. The gripper assembly 200 is movable or extendable / retractable relative to the subchannel 112a along the axial direction 114. A cutter assembly 300 may be disposed in subchannel 112b. The cutter assembly 300 is movable or extendable / retractable relative to the subchannel 112b along the axial direction 114. An endoscope 140 may be disposed in subchannel 112c. The endoscope 140 may be positioned adjacent to the gripper assembly 200 and the cutter assembly 300.
[0091] In various embodiments, the gripper assembly 200 may include a gripper 210 defining an end portion of the gripper assembly 200. The gripper assembly 200 may also include a first elongated body 220 and a first continuous joint 230 coupled between the first elongated body 220 and the gripper 210. The first continuous joint 230 may be actuated to displace the gripper 210 relative to the first elongated body 220.
[0092] Furthermore, the cutter assembly 300 may include a cutter 310 defining an end of the cutter assembly 300. The cutter assembly 300 may also include a second elongated body 320; and a second continuous joint 330 coupled between the second elongated body 320 and the cutter 310. The second continuous joint 330 may be actuated to displace the cutter 310 relative to the second elongated body 320.
[0093] In various embodiments, the first elongated body 220 may define a gripper body axis 222. The gripper body axis 222 may be parallel to the axial direction 114. Similarly, the second elongated body 320 may define a cutter body axis 322. The cutter body axis 322 may be parallel to the axial direction 114. The endoscope 140 may define an endoscope body axis 142. The endoscope body axis 142, the gripper body axis 222, and the cutter body axis 322 may be radially spaced about the axial direction 114. In other words, the endoscope body axis 142, the gripper body axis 222, and the cutter body axis 322 may be offset from each other by an angular offset (see [reference]). Figure 9 ).
[0094] In various embodiments, the housing 110 may maintain the relative orientation between the first elongated body 220 and the second elongated body 320. In various embodiments, the gripper body axis 222 is spaced apart from and parallel to the cutter body axis 322.
[0095] In various embodiments, the first continuum joint 230 may be actuated by a plurality of chordaes or cables. In various embodiments, the second continuum joint 330 may be actuated by a plurality of chordaes or cables. In various embodiments, each of the plurality of chordaes may be tensioned. Therefore, the transurethral resection system 50 may also include an actuator 550 operatively coupled to the transurethral resection device 100. The actuator 550 may be a chordae tendon tensioner configured to independently actuate the grasper assembly 200 and the cutter assembly 300. In various embodiments, the first continuum joint 230 and the second continuum joint 330 may be actuated independently and / or simultaneously by the chordae tendon tensioner.
[0096] refer to Figure 6 and Figure 7 In various embodiments, the transurethral resection device 100 may be coupled to an irrigation sheath 600, which defines a device channel 612. In various embodiments, the transurethral resection device 100 may further include a base 120 and a connector 130. The connector 130 may be coupled to a coupling portion 630 of the irrigation sheath 600. Reference Figure 6 and Figure 7 The transurethral resection device 100 can enter the device channel 612 by translational movement, and then rotate to couple the connector 130 to the coupling portion 630 of the irrigation sheath 600. In one example, the coupling between the connector 130 and the coupling portion 630 can be a bayonet coupling, which minimizes the relative movement between the housing 110 and the irrigation sheath 600 during use, achieving a secure coupling.
[0097] Figures 8 to 10 The transurethral resection device 100 is shown coupled to the irrigation sheath 600. In various embodiments, the irrigation sheath 600 may include an irrigation inlet path 640 for supplying fluid / fluid to the bladder through the irrigation sheath 600; and an irrigation outlet path 650 for discharging fluid / fluid from the bladder. To mitigate or prevent leakage or seepage, the transurethral resection device 100 may be fluid-tightly coupled to the device channel 612. In other words, the transurethral resection device 100 may form a fluid seal with the device channel 612 such that fluid does not leak through the connection between the transurethral resection device 100 and the irrigation sheath 600.
[0098] refer to Figure 8 , Figure 9 and Figure 10 The flushing sheath 600 may include an inner sheath 610 coupled to an outer sheath 620. The inner sheath 610 may be coaxially coupled to the outer sheath 620; in other words, the inner sheath 610 may share a common axial axis with the outer sheath 620. In various embodiments, the device channel 612 may be defined by the inner diameter of the inner sheath 610.
[0099] refer to Figure 9 In various embodiments, the inner sheath 610 and the transurethral resection device 100 may jointly define the irrigation inlet path 640. In various embodiments, the inner sheath 610 and the outer sheath 620 may jointly define the irrigation outlet path 650. In various embodiments, the outer sheath 620 may include a plurality of holes or through-holes allowing fluid to flow from the bladder into the irrigation outlet path 650. It is understood that the fluid volume in the bladder can be controllably altered by controlling the corresponding flow rates in the irrigation inlet path 640 and the irrigation outlet path 650.
[0100] Figure 11 and Figure 12 A gripper assembly 200 according to various embodiments is shown. The gripper assembly 200 is movable 201 (extending or retracting) relative to the channel 112 along the axial direction 114. This provides the gripper assembly 200 with a first degree of freedom (DOF) of movement 201.
[0101] In various embodiments, the grasper assembly 200 may include a grasper 210 configured as a jaw grasper 210. The jaw grasper 210 may include a first jaw portion 211 pivotable 202 relative to a second jaw portion 212 to achieve grasping motion 215. This provides the grasper assembly 200 with a second degree of freedom (DOF) of movement 202. The grasper assembly 200 may also include a first elongated body 220 defining a grasper body axis 222. In various embodiments, the grasper body axis 222 may be parallel to the axial direction 114 of the transurethral resection system 50. The first elongated body 220 may rotate 203 about the grasper body axis 222, for example, via a torque coil coupled to the actuator 550. This provides the grasper assembly 200 with a third degree of freedom (DOF) of movement 203.
[0102] In various embodiments, the first elongated body 220 can be coupled to the gripper 210 via a first continuous joint 230. In such... Figure 11 In the exemplary embodiment shown, the first elongated body 220 may be coupled to the first continuous joint 230 via a first connecting portion 224 of the first elongated body 220. The first continuous joint 230 may be actuated by a tendon chord 240 to displace the gripper 210 relative to the first elongated body 220 by 204 / 205. The tendon chord 240 may pass through the first elongated body 220 and the first continuous joint 230 to be fixedly coupled to the gripper 210. In various embodiments, the tendon chord 240 may be independently actuated to change the tension applied to the gripper 210, applying a variable force to the first continuous joint 230 to actuate the first continuous joint 230.
[0103] In such Figure 11 In the various embodiments shown, the first continuum joint 230 can be actuated to move the gripper 210 204 along a gripper plane 208 defined by orthogonal axes 83 and 87. In various embodiments, the first continuum joint 230 can be bent 204 within the gripper plane 208 about axis 85. This provides the gripper assembly 200 with a fourth degree of freedom (DOF) of movement 204.
[0104] In some embodiments, the first continuum joint 230 is bendable 205 about axis 87 in a plane orthogonal to the gripper plane 208. This provides the gripper assembly 200 with a fifth degree of freedom (DOF) of movement 205. Therefore, the first continuum joint 230 is bendable about two orthogonal axes 85 / 87, which are orthogonal to the gripper body axis 222.
[0105] Figure 13 and Figure 14 A cutter assembly 300 according to various embodiments is shown. The cutter assembly 300 is movable 301 (extending or retracting) relative to the channel 112 along the axial direction 114. This provides the cutter assembly 300 with a first degree of freedom (DOF) of movement 301.
[0106] In various embodiments, the cutter 310 may be configured as an electrocautery cutter 312. In other embodiments, the cutter 310 may be configured as a laser ablation cutter. As an example, the cutter 310 may include various geometries, such as a triangular end 312A (…). Figure 15A ), hook-shaped end 312B ( Figure 15B ), straight end 312C ( Figure 15C )wait.
[0107] The cutter assembly 300 may further include a second elongated body 320 defining a cutter body axis 322. In various embodiments, the cutter body axis 322 may be parallel to the axial direction 114 of the transurethral resection system 50. The second elongated body 320 may rotate 302 about the cutter body axis 322, for example, via a torque coil coupled to the actuator 550. This provides the cutter assembly 300 with a second degree of freedom (DOF) of movement 302. In various embodiments, the second elongated body 320 may be coupled to the cutter 310 via a second continuum joint 330.
[0108] In various embodiments, the cutter assembly 300 may include a rotary joint 326 coupled between the second elongated body 320 and the second continuous body joint 330. Figure 14 The rotary joint 326 can rotate or pivot 303 about the rotation axis 327 to move the cutter 310 and the second continuum joint 330 together relative to the second elongated body 320. This provides the cutter assembly 300 with a third degree of freedom (DOF) of movement 303.
[0109] In such Figure 13In the exemplary embodiment shown, the second elongated body 320 may be coupled to the second continuous joint 330 via a second connecting portion 324 of the second elongated body 320. The second continuous joint 330 may be actuated by a tendon chord 340 to displace the cutter 310 relative to the second elongated body 320 by 304 / 305. The tendon chord 340 may pass through the second elongated body 320 and the second continuous joint 330 to be fixedly coupled to the cutter 310. In various embodiments, the tendon chord 340 may be independently actuated to change the tension applied to the cutter 310, applying a variable force to the second continuous joint 330 to actuate the second continuous joint 330.
[0110] In such Figure 13 In the various embodiments shown, the second continuum joint 330 can be actuated to move the cutter 310 304 along a cutter plane 308 defined by orthogonal axes 83 and 85. In various embodiments, the second continuum joint 330 can be bent 304 about axis 87 in the cutter plane 308. This provides the cutter assembly 300 with a fourth degree of freedom (DOF) of movement 304.
[0111] In various embodiments, the second continuum joint 330 may be actuated to displace the cutter 310 along a sweep path 314 in the cutter plane. In some embodiments, the cutter 310 may move along the sweep path 314 at a varying speed in response to control of the second continuum joint 330 by the controller 500 and the actuator 550. In other embodiments, the second continuum joint 330 may be actuated to displace the cutter 310 periodically or cyclically along the sweep path 314.
[0112] In various embodiments, the cutter plane 308 may be orthogonal to the gripper plane 208 to achieve the lifting and cutting motion described in the preceding section.
[0113] In some embodiments, the second continuum joint 330 is bendable 305 about axis 85 in a plane orthogonal to the cutter plane 308. This provides the cutter assembly 300 with a fifth degree of freedom (DOF) of movement 305. Therefore, the second continuum joint 330 is bendable about two orthogonal axes 85 / 87, which are orthogonal to the cutter body axis 322.
[0114] In various embodiments, the first continuum joint 230 can be actuated to move the gripper 210 within a gripper angular displacement range. This gripper angular displacement range defines the limits of the gripper's movement. The gripper angular displacement range is within the gripper plane 208. Similarly, the second continuum joint 330 can be actuated to move the cutter 310 within a cutter angular displacement range. This cutter angular displacement range defines the limits of the cutter's movement. The cutter angular displacement range is within the cutter plane 308. In various embodiments, the gripper angular displacement range may be greater than the cutter angular displacement range.
[0115] In various embodiments, the first continuous joint 230 can be actuated to move the gripper 210 away from the cutter body axis 322. Similarly, the first continuous joint 230 can also be actuated to move the gripper 210 toward the cutter body axis 322.
[0116] In various embodiments, the second continuous joint 330 can be actuated to move the cutter 310 away from the gripper body axis 222. Similarly, the second continuous joint 330 can be actuated to move the cutter 310 toward the gripper body axis 222.
[0117] Figures 16 to 21 The illustrations depict continuous joints according to various embodiments. It is understood that the description of the continuous joints is generally applicable to each of the first continuous joint 230 and the second continuous joint 330. The configuration of each of the first continuous joint 230 and the second continuous joint 330 can be configured as required.
[0118] Figure 16 and Figure 17 A corresponding perspective view of the continuous joint 230 / 330 is shown. The continuous joint 230 / 330 may include a plurality of discs 400 that are stacked and contacted along joint axes 232 / 332. The joint axis 232 / 332 of each continuous joint 230 / 330 may be coaxial and parallel to the corresponding gripper body axis 222 and cutter body axis 322. The joint axis 232 / 332 may be parallel to the axial direction 114. Figure 11 and Figure 13 In the various embodiments shown, a plurality of tendineae may pass through each of the plurality of discs 400. In the various embodiments, each of the plurality of tendineae may be tensioned.
[0119] Now for reference Figures 18 to 21Each disk 400 may define a corresponding disk axis 402. The disk axis 402 may define a central axis of the disk 400. In various embodiments, each disk 400 may include a first curved surface 410 and an opposing second curved surface 420. The first curved surface 410 and the second curved surface 420 may be spaced apart along the disk axis 402.
[0120] In various embodiments, the first curved surface 410 may define a first ridge 412 having a first curvature. The first curvature may be inclined from the first ridge 412 toward the second curved surface 420. The first ridge 412 may intersect the disk axis 402. Similarly, the second curved surface 420 may define a second ridge 422 having a second curvature. The second curvature may be inclined from the second ridge 422 toward the first curved surface 410. The second ridge 422 may intersect the disk axis 402. In various embodiments, the first curved surface 410 and the second curved surface 420 may be configured to define an angle (α) between the first ridge 412 and the second ridge 422. In various embodiments, the angle (α) may be a right angle or 90 degrees. In various embodiments, the first ridge 412 may be orthogonal to the disk axis 402 relative to the second ridge 422. In various embodiments, each of the first ridge 412 and the second ridge 422 may be orthogonal to the disk axis 402.
[0121] In such Figure 19 In the various embodiments shown, the disc 400 may include a plurality of first through holes 430 aligned with the first ridge 412. The disc 400 may include a plurality of second through holes 440 aligned with the second ridge 422. Each of the plurality of tendineae 240 / 340 may pass through a corresponding through hole in the plurality of first through holes 430 and the plurality of second through holes 440. In various embodiments, the disc 400 may also include a central through hole 450, which defines a path for connecting other tendineae and / or wires to the respective grippers 210 and cutters 310.
[0122] Figure 20 A first side view (view D) of the disc 400 of the first ridge 412 is shown. Figure 21 A second side view (view E) of the disc 400 of the second ridge 422 is shown.
[0123] In some embodiments, the disc 400 may include a single curved surface, such as a first curved surface 410 defining a first ridge 412. The opposing second surface may be a flat or substantially flat surface. Such discs 400 are typically disposed at the ends of the continuum joints 230 / 330.
[0124] In some embodiments, the plurality of first through holes 430 and the plurality of second through holes 440 may be rotationally symmetrical about the disk axis 402 (e.g. Figure 19 (As shown).
[0125] refer to Figure 22A and Figure 22B In various embodiments, each of the plurality of disks may form a corresponding line contact with an adjacent disk among the plurality of disks. For example, refer to Figure 22A Disc 400a can form line contact 405 with adjacent disc 400b. In various embodiments, in response to a change in the tension of one or more chordae tendineae, disc 400b can be actuated to displace the line contact 405, such as... Figure 22B As shown. Therefore, for a continuous joint, a selected line contact in the corresponding line contact can be displaced in response to a change in the tension of at least one of the plurality of chordaes.
[0126] Figures 23A to 23D The illustration shows a method of operating the transurethral resection device 100 and the transurethral resection system 50. (Reference) Figure 23A The gripper assembly 200 can be actuated to grip a target portion 92 (e.g., a tumor) positioned on a target surface 91 (e.g., the bladder wall) using the gripper 210. While holding the target portion 92 using the gripper 210, the gripper 210 can move 204 or bend away from the target surface 91 along the gripper plane 208. The tissue between the target portion 92 gripped by the gripper 210 and the rest of the bladder wall can be stretched by the bending or angular displacement of the gripper 210, while the channel 112 remains substantially stationary. This allows the stretched tissue to intersect the path of the cutter 310 as the cutter advances along the axial direction 114. (See below for further details.) Figure 23B The cutter assembly 300 can be actuated to move the cutter 310 304 within the cutter plane 308 to cut between the target portion 92 and the target surface 91. The cutter plane 308 may be orthogonal to the gripper plane 208. (Refer to the following...) Figure 23C The cutter assembly 300 can be actuated to displace or move the cutter 310 along a sweep path 306 within the cutter plane 308. In some embodiments, the cutter 310 can move periodically along the sweep path 306. The sweep path 306 advances toward the target portion 92 to achieve separation of the target portion 92 from the target surface 91. In some examples, the cutter 310 reciprocates along the sweep path 306 while advancing axially, thereby cutting along an arcuate zigzag path. This keeps the cutter 310 within the field of view of the endoscope 140 throughout the cutting process.
[0127] refer to Figure 24 It is understood that the cutting plane 308 is generally parallel to the target surface 91, and the cutter 310 moves within the cutting plane 308, which reduces the risk of accidentally puncturing the target surface 91.
[0128] Figure 25 This is a flowchart of a method 7000 for operating a transurethral resection device. The method 7000 includes: in block 7100, grasping a target portion disposed on a target surface with a grasper; in block 7200, while holding the target portion with the grasper, moving the grasper away from the target surface along a grasper plane; and in block 7300, moving a cutter in a cutter plane to cut between the target portion and the target surface, wherein the cutter plane is orthogonal to the grasper plane.
[0129] Exemplary Example – Robot-Optimized Endoscopic Cystoid Tumor Resection (ROBERT)
[0130] In an exemplary embodiment, this document discloses a robot-optimized cystoscopic tumor resection. technique The ROBERT system is configured to facilitate efficient, comfortable, and safe transurethral en bloc tumor resection in various bladder regions. It employs a rigid-body approach with a continuum end effector, combined with a chordae tendineae-sheath mechanism (TSM) to transfer load from the proximal motor to the distal end effector. This configuration offers several advantages, including mobility, lightweight, small size, high force capacity, reliability, and safety.
[0131] Using Robert's proposed transurethral en bloc resection of bladder tumors (TUERBT) procedure
[0132] The bladder wall consists of several layers, from the innermost to the outermost: the lining, submucosa, muscle layer, and fat layer. Non-malignant bladder cancer (NMIBC) typically originates from the lining or submucosa, such as... Figure 4A As shown. The proposed steps for performing TUERBT using the ROBERT system are as follows: Figures 4B to 4D As shown.
[0133] The procedure begins with the insertion of an irrigation sheath through the urethra into the bladder, similar to a standard TURBT. Next, a dual-arm robot and endoscope are inserted and secured within the irrigation sheath. Then, a gripper grasps the tumor and lifts it to stretch surrounding tissue. Figure 4B Afterwards, the base of the tumor was carefully removed using an electrocautery cutter, ensuring negative margins. Figure 4C For larger tumors, the orientation of the resection scope can be manually adjusted to obtain the optimal resection angle. Repeat these steps to perform en bloc resection with negative resection margins, such as... Figure 4D As shown.
[0134] In a recent randomized, multicenter phase III trial, TUERBT significantly reduced the 1-year recurrence rate in patients with ≤3cm NMIBC tumors compared to conventional resection. The results support TUERBT as a first-line surgical treatment for bladder tumors ≤3cm. However, due to technical difficulties (e.g., tumor location, tumor morphology), approximately 12% of patients in the TUERBT group ultimately underwent conventional resection because traditional cutting and electrocautery tools can only operate within a limited plane. Therefore, a resection endoscope with sufficient flexibility, a variety of instruments, a larger working space, and the ability to achieve negative resection margins will transform NMIBC surgical practice, as it will reduce the recurrence rate of NMIBC and improve the success rate of TUERBT by overcoming the technical difficulties currently unattainable with conventional surgical techniques.
[0135] To address the aforementioned shortcomings, the ROBERT system was proposed. A schematic diagram of the ROBERT system is shown below. Figure 26A As shown. The ROBERT system includes a robotic resection endoscope, main electronics, and an endoscope tower. Figure 26B The prototype and its setup in the operating room are shown. The robotic resection endoscope integrates a flexible endoscope (URF–V3, Olympus, Japan) and a pair of irrigation sheaths (A22026A and A22040T, Olympus, Japan, etc.). Figure 26C (As shown), a dual-arm robot and a 3D-printed adapter. Figure 26D A close-up view of the robotic instrument is shown. The resection endoscope includes four tethered lines connected to the main electronics: (1) an endoscope connection to the video processor in the endoscope tower; (2) a wire connecting the end of the bipolar cutter to the electrocautery system (VIO300D, Erbe, USA. Setup: Bipolar 60W, Effect Level 4); (3) a TSM from the end effector to the actuator; and (4) a supply and discharge line for saline flushing connected to the flushing sheath (see [link to relevant documentation]). Figure 26C The supply pipe connects to a suspended brine bag, while the discharge pipe connects to a waste tank on the floor.
[0136] The assembly process of the robotic resection scope is summarized in Figure 27A First, insert the instruments and endoscope of the dual-arm robot into the adapter, and then install the adapter onto the irrigation sheath. The fully assembled robotic resection endoscope appears as follows: Figure 27B As shown.
[0137] The distal end of the dual-arm robot, such as Figure 27CAs shown. The end effector is 3D printed using 316L stainless steel via direct metal laser sintering (Protolabs, USA). Both robotic instruments have pitch (G2, C2), yaw (G3, C3), translation (G4, C4), and rotation (G5, C5) motions, where "C" represents the cutter and "G" represents the gripper. The gripper also has an additional gripping degree of freedom (G1), while the cutter has an additional pre-set pin joint (C1) to enhance triangulation.
[0138] The pitch and yaw movements of the end effector are achieved by a super-redundant wrist consisting of a stack of rolling contact discs controlled by a tendon cable. Each disc has a curved top and bottom surface and five vertical holes: a central hole with a diameter of 0.8 mm for the tendon cable or cutter wire of the G1; and four side holes with a diameter of 0.4 mm for the tendon cable. When the tendon cable (0.21 mm diameter stainless steel wire rope, SE-21 Sinyo, Japan, breaking strength 55.9 N) is pulled, the discs roll on adjacent discs, creating a bend in the super-redundant wrist. This disc-type end effector is preferred because it is easy to assemble and provides internal space for the tendon cable or wire. Figure 27E The diagram illustrates the chordae tendineae pathways for pitch and yaw movements in a super-redundant wrist. The actuation of the end effector via TSM is shown below. Figure 27F As shown. Two motors control each degree of freedom, achieving the corresponding yaw, pitch, or gripping motions of the end effector by retracting one chord while simultaneously releasing the other. The chord from the end effector passes through a protective sheath (outer diameter 0.5 mm, inner diameter 0.4 mm, Asahi–intecc, Japan) within a rigid tube section (34 cm long, 2.4 mm outer diameter, 2.1 mm inner diameter, stainless steel). A 3D-printed tapered section (316L stainless steel) connects the rigid tube and the torque coil (1.0 m long, 4.1 mm outer diameter, 3.3 mm inner diameter, Asahi–intecc, Japan). A larger sheath (1.2 m long, 0.9 mm outer diameter, 0.5 mm inner diameter, Asahi–intecc, Japan) is used within the torque coil to protect the chord. The proximal end of each chordae passes through a button-type force sensor (LTH300, FUTEK, USA) and is then connected to a corresponding pulley on the motor (2657W024CR with IERS3–500 encoder, Faulhaber, Germany). The force sensor and motor are connected to a control board (QPIDe, Quanser Inc., Canada). Figure 27GThe actuation of translational and rotational motions is illustrated. Translations within a 40mm range (G4 and C4) are achieved by an electric linear slider (ARM46SMK, Oriental Motor, and KRF5 linear slider, THK). A motor mounted on top of the slider transmits torque through a torque coil, enabling ±180-degree rotational motion of the end effector (G5 and C5).
[0139] The surgeon's hand movements, including yaw, pitch, grasping, rotation, and translation, are collected by a pair of haptic devices (Omega7, Force Dimension, Switzerland), which serve as control inputs for the robotic instruments. An open-loop control algorithm was developed in MatlabSimulink to linearly scale these inputs to control the corresponding motors to achieve the motion of the end effector. Furthermore, the tension of the chordae tendineae is monitored by force sensors. If the tension exceeds a user-defined maximum (20N), the corresponding motors are adjusted to maintain the maximum tension. Before operation or testing, all chordae tendineae are retracted to achieve a pre-tension of 1N.
[0140] Estimating the working space of the instrument
[0141] The workspace size or dimensions of an over-redundant wrist can be adjusted by changing the size and number of discs. A longer wrist provides a larger workspace, thus reducing the need for frequent repositioning of the resection endoscope. However, this increased length also results in the endoscope being further from the surgical site. To address this issue, a kinematic model was developed to estimate the workspace based on the disc geometry. Given the pretension applied to the chordae tendineae and the disc stacking constrained by the chordae tendineae, two assumptions were made: (1) each disc rolls on its adjacent discs without slippage; (2) each disc experiences the same rotation angle, which implies the same pitch angle. and yaw angle This is constant for all disks.
[0142] Taking the gripper as an example, it has 8 discs, 10 of which are rolling surfaces for pitch and 8 for yaw. When the end effector pitches and rotates... yaw rotation At that time, according to assumption (2), the rotation angle of the disk is calculated as the yaw. and pitch The range of motion of the end effector and Limited to ±80°. The disk has a radius of... The thickness at the curved surface and center is The top and bottom cylindrical surfaces are perpendicular to each other.
[0143] Next, the rolling disk contact is modeled as a combination of pin joints and prism joints to construct the transformation matrix using Denavit–Hartenberg (DH) parameters. The DH parameters of the gripper are listed in Table I. Here, and This represents translation and rotation along a local x-axis, while and This represents translation and rotation along the local z-axis. The local coordinate system (LC)0 is located at the bottom of the wrist base. This represents the height of the base. The relevant coordinates in disks 1 and 2 are labeled... Figure 28A and Figure 28B In the middle, geometric relationships and contact lines are as follows Figure 28C and Figure 28D As shown. When disk 1 is in Figure 28A Mid-rotation yaw angle At that time, the corresponding contact wire from Shift to in the plane Superscript This indicates the neutral position of the local coordinates when the wrist is extended. Figure 28C Zhong Cong arrive The displacements Δ1 and Δ2 are expressed as:
[0144]
[0145] Similarly, such as Figure 28D As shown, the second contact line (between disks 1 and 2) originates from... Shift to The displacements are Δ3 and Δ4:
[0146]
[0147] From the first contact line to the axis Projected distance of the second contact line It can be written as:
[0148]
[0149] LC 3 to 6 represent the transition from the first rolling contact to the second rolling contact. Then, based on assumption (2), the DH parameters of LC7 to 10, 11 to 14, and 15 to 18 are the same as those of LC 3 to 6. LC 20 is located at the distal end. From The distance to the end.
[0150] The cutter's DH parameters are detailed in Table II, while the dimensional parameters of the gripper and cutter are shown in Table III. It is worth noting that the cutter has an additional rotary joint (C1) before the wrist for yaw motion, and its disc count is relatively low. Furthermore, This indicates the length of the additional joint. This indicates its rotation angle.
[0151] The workspace of the gripper and cutter was obtained without considering translational and rotational motion, such as Figure 28E and Figure 28F As shown. Joint C1 is indicated by a white arrow. When C1 is configured as... At this time, a portion of the cutter's working surface shifts to the right, causing a displacement of the workspace and resulting in better triangulation. Therefore, the rotation angle of C1 is configured before surgery according to the surgeon's needs.
[0152]
[0153]
[0154]
[0155] Experiments and Results
[0156] Motion tracking experiment of end effector
[0157] Optical markers are mounted at the end of the gripper to track its position using four motion-tracking cameras (Prime 13W, OptiTrack, USA), such as... Figure 29A As shown.
[0158] First, straighten the end effector while applying a 1N pretension on all chordae tendineae. After applying the pretension, record the chordae tendineae length as zero. Then, retract or release chordae tendineae G3+ and G3– while keeping chordae tendineae G2+ and G2– unchanged (e.g., ...). Figure 27E As shown), to achieve the desired yaw angle (such as...). Figure 29B (As shown). Record the corresponding chordae tendineae length. and And it is displayed. A positive chord length indicates the release of the corresponding chord, while a negative value indicates the retraction of the corresponding chord. After each movement, the apparatus returns to its initial pose. For yaw angle:
[0159] Repeat this process. Similarly, the wrist of the end effector is also bent to achieve different pitch angles. Through this process, the relationship between the length of the chordae tendineae and the wrist angle for pure yaw and pitch movements at ±40° and ±80° was established.
[0160] By combining these chordae tendineae adjustments and Used for oscillation, and (For pitch control), the distal end of the gripper can reach 25 points, covering the entire workspace. The distal end position is acquired by a motion tracking system. This process is repeated five times.
[0161] Tracking results as follows Figure 29C As shown, Figure 29D A detailed magnified view of a point from five runs is shown. The experimental values are compared with those estimated by the proposed model. Displacement errors at 25 locations are shown below. Figure 29E As shown. The average displacement error is 2.08 mm, approximately 12% of the end effector length. The standard deviation (STD) for the 25 positions is as follows. Figure 29F As shown, the STD value ranges from 0.03 mm to 0.19 mm. A lower STD value indicates that the robot's motion is highly repeatable, demonstrating the consistency of wrist performance.
[0162] Experiments and Results – Wrist Strength and Grip Strength
[0163] The force applied by G3 is measured using a test bench, such as... Figure 30A and Figure 30B As shown in the illustration. The illustration is a schematic diagram of the wrist force measurement device. The wrist force of G3 was measured at different wrist angles (0°, 10°, 20°, 30°, or 40°), which were determined using a protractor. A cable was used to connect the fixed jaw and the force sensor (LTH300, FUTEK), with the center of the gripper shaft, cable, and force sensor aligned in the same horizontal plane. The proximal chordae tendineae tension was maintained at 20N to generate the maximum wrist angle. The force sensor was then moved to bend the continuum structure to the desired wrist angle, keeping the cable perpendicular to the gripper. The force sensor readings were recorded at the desired wrist angle, and the measurements were repeated three times for all joint angles. The average values were plotted on... Figure 30D The maximum average wrist force is 0.48 ± 0.02 N at 0° and decreases to 0.12 ± 0.01 N at 40°. Since G2 has a similar structure to G3, its wrist force is expected to be similar. Therefore, the gripper should ideally approach the target in an upright posture. A schematic diagram of gripping force measurement is shown below. Figure 30CAs shown. The grasper is fixed from the wrist of the continuum to the crimping bead on the fixed jaw, allowing only jaw movement. A cable is connected to the midpoint of the movable jaw, maintaining a proximal chordae tension of 20 N on the closed chordae tendineae. The force sensor is then moved to pull the movable jaw open. The reading when the movable jaw is open is recorded as the maximum grasping force. The average of six measurements was 0.69 N, which is low compared to large-diameter surgical graspers used for colonoscopy and laparoscopy. However, the force required to manipulate bladder tissue varies with instrument size. When the bladder is fully distended, tissue tension is high and the wall is thinner, requiring greater grasping and wrist forces. On the other hand, when the bladder is half-distended, tissue tension is low and the wall is thicker, thus requiring less grasping and wrist forces. Therefore, it is necessary to evaluate grasping performance in ex vivo experiments.
[0164] Experiments and Results – In Vitro Experiments
[0165] To evaluate the en bloc resection capability of the robotic resection system, ex vivo tissue resection experiments were conducted using bladders from 60–70 kg female pigs. The ex vivo experimental setup included… Figure 31A As shown. En bloc tissue resection was performed on the posterior wall, top, and anterior neck, as illustrated. Figure 31B As shown. For the anterior neck, resection is performed 3 cm from the urethra. The anterior neck presents an angle of attack of approximately 0°, which is challenging and makes grasping difficult. The apex requires an angle of attack of 90°, complicating the cutting process. In contrast, the anterior and posterior walls offer an angle of approximately 40°, suitable for cutting and grasping.
[0166] The bladder volume is controlled by adjusting the supply and discharge valves of the irrigation sheath. A semi-filled bladder results in a shorter distance between the end effector and the anterior wall, ensuring the wall thickness is not too thin, thus minimizing the risk of perforation during resection. The irrigation function allows the surgeon to make additional adjustments to the surgical site.
[0167] The surgical site was marked by injecting dye ink (indigo carmine, Sigma-Aldrich, Germany) between the muscle and mucosal layers. The bladder was then dilated and a robotic resection scope was inserted. The scope and bladder volume were adjusted to reach the marked surgical site. The procedure was then performed. Figures 4B to 4D The TUERBT process described herein.
[0168] Endoscopic views during the procedure, as shown Figures 31C to 31E As shown, the excised tissue is as follows Figures 31F to 31H As shown. In all experiments, a tissue piece approximately 10 × 10 mm in size and 2–3 mm in thickness was removed. Muscle tissue was observed during the removal process, such as… Figures 31C to 31DAs indicated by the markings in the middle. These results demonstrate that, in this experimental setting, the gripping force and wrist strength were sufficient for tissue manipulation and successful completion of the TUERBT procedure. Furthermore, no leakage or perforation was observed after tissue resection. The robotic resection endoscope was operated by an engineer with ten hours of training. Resection of the posterior wall and anterior neck each took approximately 10 minutes, while resection of the top took approximately 25 minutes.
[0169] Experiments and Results – In Vivo Experiments
[0170] In vivo studies were conducted in a 59 kg pig model to demonstrate the feasibility of ROBERT in real-world surgical scenarios. This animal study was reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) of the National University of Singapore. Figure 26B The experimental setup within the operating room is shown. The main electronic equipment cart is positioned in a straight line with the operating table, with the surgeon's console and endoscope tower placed on either side of the cart. The endoscope support is fixed to the operating table. The anesthetized pig is placed on the operating table in a supine position with its head away from the main electronic equipment cart.
[0171] Initially, a guidewire and endoscope are inserted into the bladder via the urethra. The endoscope is then withdrawn, and a dilator is inserted over the guidewire to dilate the urethra. Next, an irrigation sheath is inserted along the guidewire and dilator, and the endoscope is reintroduced into the irrigation sheath to visually confirm its position within the bladder. Once confirmed, the endoscope, dilator, and guidewire are removed. The endoscope is then assembled into an adapter along with the dual-arm robot. This adapter assembly is inserted and coupled to the irrigation sheath. The bladder is inflated by activating the irrigation sheath's supply valve, and the resection scope is oriented to approach the posterior wall.
[0172] Then the proposed TUERBT procedure is performed to remove a piece of tissue from the bladder wall, such as... Figure 32A As shown. Successfully removed ( Figure 32B and Figure 32C Afterward, remove the adapter assembly to remove the excised tissue. Next, reassemble the adapter assembly and reposition the resectoscope to treat the anterior wall. Manually adjust the irrigation to control bladder volume, keeping the posterior wall facing the resectoscope. Repeat the proposed TUERBT procedure as follows: Figures 32D to 32F As shown.
[0173] In this in vivo study, two en bloc resections were successfully performed without interruption: the first from the posterior wall (5×5 mm), and the second from the anterior wall (4×4 mm). The robotic gripper demonstrated sufficient payload capacity to grasp and lift the tissue, such as... Figure 32A and Figure 32DAs shown. The resections were completed by the surgeon within eight minutes and six minutes, respectively. The surgeon confirmed that both resections reached the muscle layer, as evidenced by the exposed muscle fibers at the resection sites. Furthermore, no tissue slippage, electrical leakage, or unexpected system shutdown occurred during the procedure.
[0174] As an alternative description, this disclosure relates to a resection module including an end effector. This module can be assembled with other components to form a resection scope with the payload and flexibility to manipulate tissue surrounding the tumor, thereby enabling en bloc resection of the tumor. This facilitates efficient, comfortable, and safe transurethral en bloc tumor resection in various bladder regions. This disclosure also relates to a resection scope having the disclosed resection module. This module can shorten the duration of the procedure, potentially reducing recovery time, pain / discomfort, and the risk of complications. The module also improves surgical precision. The module can be used with existing endoscopic instruments, such as irrigation sheaths, which provide appropriate water circulation to ensure safe intrabladder pressure and maintain clear visualization during the procedure. The module can be remotely operated by a surgeon.
[0175] Therefore, this disclosure relates to a resection module comprising: a) an end effector located at one end of the resection module; b) a plurality of disks having at least one curved surface, the end effector being movably coupled to the plurality of disks; and c) at least three tendineae passing through the plurality of disks and coupled to the end effector for actuating the end effector.
[0176] As shown in the figure, the resection module includes an end effector. A first resection module includes a first end effector configured to grasp the tumor. A second resection module includes a second end effector configured to ablate the tumor. The first end effector is capable of grasping and lifting the tumor, while the second end effector is capable of cutting to remove the tumor. The procedure, from initial grasp to complete resection, can last within six minutes.
[0177] This module utilizes multiple discs having at least one curved surface and at least one tendon chord passing through the discs for actuating the end effector, preferably at least three tendons. The multiple discs with at least one curved surface form a continuous wrist in the end effector. A continuous wrist or joint in an end effector is a joint in which the end effector can bend continuously along its length and can operate in confined spaces due to its compactness and flexibility. When the tendon chord is pulled, the discs roll on adjacent discs without bending any part of the discs, thus forming a bend along the end effector. As the end effector bends, the discs roll on adjacent contact discs, and the contact line shifts. Therefore, each disc is a combination of a prismatic joint and a rotary joint. Each disc rolls on the next contact disc without slipping, and each disc has an equal rotation angle with respect to each axis of rotation, and the curvature of the continuous wrist remains constant throughout the process. The arrangement of multiple discs with at least one tendon chord prevents stuck movement and motion lag due to inter-tube friction in other concentric tube designs, and prevents accidental movement and inaccurate positioning. The device can maintain its flexibility and payload, thereby enabling en bloc tumor resection.
[0178] The resection module can be attached to existing endoscopes, sheaths, and / or obturators. The resection module can be mounted or assembled to form a resection endoscope. When two resection modules are combined to provide a first and a second end effector, both modules can be fitted into existing irrigation sheaths that are compatible with existing endoscopes. In some embodiments, a plurality of discs are stacked on top of each other along the longitudinal axis of the resection module. The discs are stacked on top of each other to form a continuous wrist in each end effector. This longitudinal axis is also the x-axis of a local Cartesian coordinate system. The origin of the local Cartesian coordinate system is located at the center of the disc, and the z-axis points upward. The discs may be constrained by at least one tendineae passing through the stacked discs. The discs may be stacked such that when the end effector bends, the discs roll on adjacent contact discs.
[0179] In some embodiments, the plurality of disks have a single curved top surface and a flat bottom surface. A single curved surface is a surface having a single radius of curvature in a plane. At a point on the single curved surface, there are two perpendicular directions, one with non-zero curvature and the other with zero curvature. Examples of single curved surfaces include cylinders or cones.
[0180] In some embodiments, multiple disks are stacked on top of each other such that the flat bottom surface of one disk is aligned with and in contact with the flat bottom surface of its adjacent disk, wherein the curvature of a single curved top surface of the disk is rotated by 90° relative to the curvature of a single curved top surface of the adjacent disk when viewed from the longitudinal axis of the cut-off module.
[0181] In some embodiments, the plurality of disks have a single curved top surface and a single curved bottom surface, wherein the curvature of the single curved bottom surface is rotated by 90° relative to the single curved top surface when viewed from the longitudinal axis of the cut-off module.
[0182] In some embodiments, multiple disks are stacked on top of each other such that the curved top surface of one disk aligns with and contacts the curved bottom surface of its adjacent disk, with the contact line intersecting and perpendicular to the longitudinal axis of the cut-off module. This results in a straight continuum arm, i.e., a neutral position. The disks are stacked on top of each other such that when the continuum arm bends, the contact line shifts along a single curve and aligns with a direction having zero curvature, without intersecting the longitudinal axis.
[0183] In some embodiments, each of the plurality of disks is characterized by a curve in a horizontal plane (x–y plane) and a curve in a vertical plane (x–z plane). The surface is generated by sweeping the curve along the y-axis (in the x–z plane) or along the z-axis (in the x–y plane). Adjacent surfaces (e.g., the curved top surface of one disk and the curved bottom surface of its adjacent disk) lie in the same plane, while the bottom surface of the disk lies in a different plane than the top surface of the disk.
[0184] In some embodiments, the curved top surface and the curved bottom surface are symmetrical or asymmetrical with respect to the longitudinal axis of the cut-off module. The curve may be circular ( Figure 36C Parabolic curve ( Figure 36D ) or asymmetric curves ( Figure 36B In some embodiments, the curved top surface is convex and the curved bottom surface is concave. The curved surfaces of all surfaces may be the same or different, which may result in a change in the final range of motion of the continuum wrist.
[0185] In some embodiments, each disc includes at least one through-hole parallel to the longitudinal axis of the disc for the tendon chord to pass through the discs. In some embodiments, each disc includes at least one through-hole parallel to the longitudinal axis of the resection module for the tendon chord to pass through the discs. This preserves internal space for the tendon chord to pass through the end effector, minimizing the size of the device.
[0186] In some embodiments, each disc includes at least two, at least three, or at least four through holes. In some embodiments, each disc includes five through holes parallel to the longitudinal axis of the disc. In some embodiments, each disc includes five through holes parallel to the longitudinal axis of the cutting module. This allows multiple tendineae to pass through multiple discs, thereby allowing control of multiple degrees of freedom.
[0187] In some embodiments, each disk includes a central through-hole and four through-holes circumferentially positioned around the central through-hole. A tendon cable passing through the central through-hole controls the degrees of freedom of the end effector. The tendon cable may pass through any one of the four auxiliary through-holes, and two electrical wires may pass through the central through-hole. A tendon cable passing through at least one of the four through-holes circumferentially positioned around the central through-hole independently controls the degree of freedom of bending angle in the end effector. The tendon cable controlling the degree of freedom of bending angle actuates the end effector in a vertical direction perpendicular to the longitudinal axis of the cutting module. Another tendon cable controlling the degree of freedom of bending angle actuates the end effector in a horizontal direction parallel to the longitudinal axis of the cutting module.
[0188] The diameter of the through-hole can depend on the material strength and manufacturing method. It can also depend on the tendons passing through the through-hole to achieve various degrees of freedom. For example, the disc can be manufactured by 3D printing with a minimum wall thickness of approximately 0.2 mm. In some embodiments, at least one through-hole is characterized by a diameter of approximately 0.2 mm to approximately 1.0 mm. In other embodiments, the diameter is approximately 0.2 mm to approximately 0.8 mm, approximately 0.2 mm to approximately 0.6 mm, approximately 0.2 mm to approximately 0.4 mm, approximately 0.4 mm to approximately 1.0 mm, or approximately 0.4 mm to approximately 0.8 mm. In some embodiments, the diameter is approximately 0.4 mm to approximately 0.6 mm.
[0189] In some embodiments, the central through-hole is characterized by a diameter of about 0.6 mm to about 1.0 mm. In other embodiments, the diameter is about 0.6 mm to about 0.9 mm, about 0.6 mm to about 0.8 mm, about 0.7 mm to about 1.0 mm, about 0.7 mm to about 0.9 mm, about 0.7 mm to about 0.8 mm, about 0.8 mm to about 1.0 mm, or about 0.8 mm to about 0.9 mm. In some embodiments, the central through-hole is characterized by a diameter of about 0.8 mm.
[0190] In some embodiments, each of the four through holes circumferentially positioned around the central hole is characterized by a diameter of about 0.2 mm to about 0.6 mm. In other embodiments, the diameter is about 0.2 mm to about 0.5 mm, about 0.2 mm to about 0.4 mm, about 0.3 mm to about 0.6 mm, about 0.3 mm to about 0.5 mm, about 0.3 mm to about 0.4 mm, about 0.4 mm to about 0.6 mm, or about 0.4 mm to about 0.5 mm.
[0191] In some embodiments, each of the four through holes circumferentially positioned around the central hole is characterized by a diameter of approximately 0.4 mm. The dimensions of the four circumferential through holes may be smaller than that of the central through hole. This increases the strength of the disk. In some embodiments, when the disk is manufactured using 3D printing technology, the wall thickness between the through holes may be at least approximately 0.2 mm. In other embodiments, the thickness may be at least approximately 0.3 mm, at least approximately 0.5 mm, at least approximately 0.7 mm, or at least approximately 1 mm.
[0192] The thickness of each disc is adjustable to achieve various ranges or heights of motion for the end effector. In some embodiments, each disc is characterized by a thickness of approximately 0.5 mm to approximately 1.5 mm. In other embodiments, the thickness is approximately 0.5 mm to approximately 1.3 mm, approximately 0.5 mm to approximately 1.1 mm, approximately 0.7 mm to approximately 1.5 mm, approximately 0.7 mm to approximately 1.3 mm, or approximately 0.7 mm to approximately 1.1 mm. In some embodiments, the thickness is approximately 0.75 mm to approximately 1.1 mm.
[0193] In some embodiments, each disk is characterized by a thickness of about 0.5 mm to about 1.0 mm. In other embodiments, the thickness is about 0.5 mm to about 0.9 mm, about 0.5 mm to about 0.8 mm, about 0.6 mm to about 1.0 mm, about 0.6 mm to about 0.9 mm, about 0.6 mm to about 0.8 mm, about 0.7 mm to about 1.0 mm, about 0.7 mm to about 0.9 mm, or about 0.7 mm to about 0.8 mm. In some embodiments, the disk is characterized by a thickness of about 0.7 mm to about 1.5 mm. In other embodiments, the thickness is about 0.7 mm to about 1.3 mm, about 0.7 mm to about 1.1 mm, about 0.9 mm to about 1.5 mm, about 0.9 mm to about 1.3 mm, about 0.9 mm to about 1.1 mm, about 1.1 mm to about 1.5 mm, or about 1.1 mm to about 1.3 mm.
[0194] In some embodiments, each disk is characterized by a thickness of approximately 0.75 mm. In some embodiments, each disk is characterized by a thickness of approximately 1.1 mm. The top or bottom surface of each disk is curved and has a radius of curvature. The radius of curvature is the radius of a circle whose arc will most closely approximate a portion of the curved surface. The radius of curvature can affect the range of motion of the end effector. The surface of the disk can be smooth and can have a varying or constant radius of curvature. In some embodiments, the top or bottom surface of each disk is characterized by a radius of curvature ranging from approximately 0.5 mm to infinity.
[0195] In some embodiments, the top or bottom surface of each disk is characterized by a radius of curvature of about 0.5 mm to about 10.0 mm. In other embodiments, the radius of curvature is approximately 0.5 mm to about 8.0 mm, approximately 0.5 mm to about 6.0 mm, approximately 0.5 mm to about 4.0 mm, approximately 0.5 mm to about 2.0 mm, approximately 0.5 mm to about 1.9 mm, approximately 0.5 mm to about 1.8 mm, approximately 0.6 mm to about 10.0 mm, approximately 0.6 mm to about 8.0 mm, approximately 0.6 mm to about 4.0 mm, approximately 0.6 mm to about 2.0 mm, approximately 0.6 mm to about 1.9 mm, approximately 0.6 mm to about 1.8 mm, approximately 0.7 mm to about 10.0 mm, approximately 0.7 mm to about 8.0 mm, approximately 0.7 mm to about 6.0 mm, approximately 0.7 mm to about 4.0 mm, approximately 0.7 mm to about 2.0 mm, approximately 0.7 mm to about 1.9 mm, approximately 0.7 mm to about 1.8 mm, approximately 0.8 mm to about 2.0 mm, approximately 0.8 mm to about 10 ... The radius of curvature is approximately 0.5 mm to about 1.75 mm. In some embodiments, the radius of curvature is approximately 0.5 mm to about 1.75 mm.
[0196] In some embodiments, the top or bottom surface of each disk is characterized by a radius of curvature of about 1.3 mm to about 2.0 mm. In other embodiments, the radius of curvature is about 1.3 mm to about 1.9 mm, about 1.3 mm to about 1.8 mm, about 1.5 mm to about 2.0 mm, about 1.5 mm to about 1.9 mm, about 1.5 mm to about 1.8 mm, about 1.7 mm to about 2.0 mm, about 1.7 mm to about 1.9 mm, about 1.7 mm to about 1.8 mm, about 1.8 mm to about 2.0 mm, or about 1.8 mm to about 1.9 mm.
[0197] In some embodiments, the top or bottom surface of each disk is characterized by a radius of curvature of approximately 1.75 mm. In some embodiments, the top or bottom surface of each disk is characterized by a radius of curvature of approximately 0.8 mm. Alternatively, the top or bottom surface of each disk may be characterized by having a smooth curve with varying curvature. This curve can be adjusted to achieve a specific range of motion.
[0198] In some embodiments, the cut-off module includes about 2 to about 16 disks. In other embodiments, the cut-off module includes about 2 to about 15 disks, about 2 to about 14 disks, about 2 to about 13 disks, about 2 to about 12 disks, about 2 to about 11 disks, about 2 to about 10 disks, about 2 to about 9 disks, about 2 to about 8 disks, about 3 to about 16 disks, about 3 to about 15 disks, about 3 to about 14 disks, about 3 to about 13 disks, about 3 to about 12 disks, about 3 to about 11 disks, about 3 to about 10 disks, about 3 to about 9 disks, about 3 to about 8 disks, about 4 to about 16 disks, about 4 to about 15 disks, about 4 to about 14 disks, about 4 to about 13 disks, about 4 to about 12 disks, about 4 to about 11 disks, about 4 to about 10 disks, about 4 to about 9 disks, or about 4 to about 8 disks. In some embodiments, the cut-off module includes about 4 to about 8 disks. In some embodiments, the cut-off module includes about 6 to about 10 disks. In other embodiments, the cut-off module includes about 6 to about 9 disks, about 6 to about 8 disks, about 7 to about 10 disks, about 7 to about 9 disks, or about 8 to about 10 disks. In some embodiments, the cut-off module includes about 2 to about 6 disks. In other embodiments, the cut-off module includes about 2 to about 5 disks, about 2 to about 4 disks, about 3 to about 6 disks, about 3 to about 5 disks, or about 4 to about 6 disks.
[0199] In some embodiments, the ablation module includes eight discs. In some embodiments, the ablation module includes four discs. The discs may be stacked in the ablation module. The ablation module may include multiple stacked discs. Each stacked disc can be used to actuate a corresponding end effector. Each stacked disc can be actuated by a corresponding chord. Multiple stacked discs may be connected in series to form a single continuous wrist. This allows for increased maneuverability. For example, a first stack of discs may bend to the left, a second stack of discs may bend to the right, forming an S-shaped arm. In some embodiments, the chord is a wire rope or a hyperelastic wire. The wire rope may be at least two metal wires twisted into a helix to form a composite metal rope. The chord may be housed in a chord sheath. The wire rope may act as a chord in the chord-sheath mechanism and may facilitate actuation, such as Figure 27D As shown.
[0200] In a chord-sheath mechanism comprising a sheath and a chord, the sheath can be a hollow helical coil, and the chord can be a flexible cable or wire rope. When the wire rope is pulled, it slides within the sheath and, due to its displacement, transmits motion and force through the arm, thus functioning as a chord. The wire rope can be a stainless steel wire rope.
[0201] In some embodiments, the chordae tendineae are characterized by an outer diameter of about 0.1 mm to about 0.5 mm. In other embodiments, the outer diameter is about 0.1 mm to 0.4 mm, about 0.1 mm to 0.3 mm, about 0.1 mm to 0.2 mm, about 0.2 mm to 0.5 mm, about 0.2 mm to 0.4 mm, or about 0.2 mm to 0.3 mm. In some embodiments, the chordae tendineae are characterized by an outer diameter of about 0.2 mm.
[0202] In some embodiments, the chordae tendineae are characterized by a breaking strength of about 20 N to about 200 N. In other embodiments, the breaking strength is about 20 N to about 180 N, about 20 N to about 160 N, about 20 N to about 140 N, about 20 N to about 120 N, about 20 N to about 100 N, about 20 N to about 80 N, about 20 N to about 60 N, about 40 N to about 200 N, about 40 N to about 180 N, about 40 N to about 160 N, about 40 N to about 140 N, about 40 N to about 120 N, about 40 N to about 100 N, about 40 N to about 80 N, or about 40 N to about 60 N.
[0203] In some embodiments, the chordae tendineae are characterized by a breaking strength of approximately 56 N. In some embodiments, at least three chordae tendineae are housed within at least one sheath, or within three sheaths. This forms a chordae tendineae-sheath mechanism for actuating an end effector. This chordae tendineae-sheath mechanism allows load to be transferred from the motor to the end effector, enabling the end effector to maintain the magnitude of the force in the desired direction. The end effector may be located distal to a first resection module configured to grasp a tumor; or distal to a second resection module configured to ablate a tumor. The sheath may be a rigid sheath. While this restricts the degrees of freedom of the first and second arms, manual control of the arms becomes more consistent.
[0204] In some embodiments, the end effector is characterized by an outer diameter of about 1 mm to about 5 mm. In other embodiments, the outer diameter is about 1 mm to about 4 mm, about 1 mm to about 3 mm, about 2 mm to about 5 mm, about 2 mm to about 4 mm, or about 2 mm to about 3 mm.
[0205] In some embodiments, the end effector is characterized by an outer diameter of approximately 2.4 mm. In some embodiments, the end effector is selected from grippers, coagulation grippers, cutters, snares, traction tools, and scissors. Cutters can have ends of various shapes, including rings, balls, triangles, dotted ends, and curved dotted ends (hooks). Therefore, various resection modules can be modularly combined to form a resection endoscope suitable for the desired operation. For example, a surgeon may select a first resection module with a gripper component and a second resection module with a cutter component. This combination can be suitable for resecting tumors in the bladder (…). Figure 2 ).
[0206] In some embodiments, the resection module further includes an actuation device in communication with the end effector. In some embodiments, the actuation device communicates with the end effector via at least three chordaes. The actuation device may include a chordae tendon-sheath mechanism that allows the arm (end effector) to maintain the magnitude of the force in a desired direction. The end effector may be an arm configured to grasp the distal end of the tumor, or a second arm configured to ablate the distal end of the tumor.
[0207] The actuation device actuates the end effector via chordae tendineae. In some embodiments, the end effector is characterized by at least three degrees of freedom. The chordae tendineae control three degrees of freedom, such as pitch, yaw, and gripping. At least three chordae tendineae can be combined to actuate to provide at least three degrees of freedom. In some embodiments, the end effector is characterized by at least five degrees of freedom. The degrees of freedom can vary depending on the type of arm. For example, if the end effector is a gripper, the arm may include five degrees of freedom: translation, rotation, pitch (up / down), yaw (left / right), and gripping (open / close). If the end effector is a cutter, the arm may include five degrees of freedom: translation, rotation, pitch, yaw, and rotation (triangulation). The pitch and yaw degrees of freedom can be achieved by multiple discs and at least one chordae tendineae passing through the discs in each arm. This prevents jamming of the arm during use. These degrees of freedom provide the necessary flexibility for the surgeon to control the instrument while maintaining a sufficiently large payload for en bloc tumor resection.
[0208] In some embodiments, the at least one tendon cable passes through a side hole of the plurality of discs, with one end of the tendon cable connected to an end effector and the other end connected to an actuation device for pulling or releasing the tendon cable. When the tendon cable is pulled, the curved discs roll over each other, causing the contact line to shift, forming a curved posture. The contact line shifts along a single curve and aligns with a direction having zero curvature, without intersecting the longitudinal axis. Different tendon cables can control different aspects of various degrees of freedom, such as vertical movement (pitch), horizontal movement (yaw), and opening and closing movement (grip). Multiple tendon cables may be required to control a single degree of freedom. This can be configured depending on the type of component at the end effector.
[0209] In some embodiments, the end effector is characterized by a rotational roll angle of 0° to about 180°. In other embodiments, the angle is 0° to about 150°, 0° to about 120°, or 0° to about 90°. In some embodiments, the angle is 0°. In some embodiments, the angle is about 180°.
[0210] In some embodiments, the end effector is characterized by a translational movement of 0 mm to about 60 mm along the longitudinal axis of the arm. In other embodiments, the translational movement is 0 mm to about 60 mm, 0 mm to about 50 mm, or 0 mm to about 40 mm. In some embodiments, the translational movement is about 40 mm.
[0211] In some embodiments, the end effector is characterized by a pitch angle of approximately +90° to approximately –90°. In other embodiments, the angles are approximately +90° to –70°, approximately +90° to –50°, approximately +90° to –30°, approximately +90° to –10°, approximately +70° to –90°, approximately +70° to –70°, approximately +70° to –50°, approximately +70° to –30°, approximately +70° to –10°, approximately +50° to –90°, approximately +50° to –70°, approximately +50° to –50°, approximately +50° to –30°, approximately +50° to –10°, approximately +30° to –90°, approximately +30° to –70°, approximately +30° to –50°, approximately +30° to –30°, approximately +30° to –10°. Approximately +10° to –90°, Approximately +10° to –70°, Approximately +10° to –50°, Approximately +10° to –30°, Approximately +10° to –10°, 0° to –90°, 0° to –70°, 0° to –50°, 0° to –30°, 0° to –10°, Approximately +90° to 0°, Approximately +90° to +10°, Approximately +90° to +30°, Approximately +90° to +50°, Approximately +90° to +70°, Approximately +70° to 0°, Approximately +70° to +10°, Approximately +70° to +30°, Approximately +70° to +50°, Approximately +50° to 0°, Approximately +50° to +10°, Approximately +50° to +30°, Approximately +30° to 0°, approximately +30° to approximately +10°, or approximately +10° to 0°. In some embodiments, the angle is 0°. o In some embodiments, the angle is approximately 40 degrees. o In some embodiments, the angle is from 0° to approximately 40°.
[0212] In some embodiments, the end effector is characterized by a yaw angle of approximately +90° to approximately –90°. In other embodiments, the angle is approximately +90° to –70°, approximately +90° to –50°, approximately +90° to –30°, approximately +90° to –10°, approximately +70° to –90°, approximately +70° to –70°, approximately +70° to –50°, approximately +70° to –30°, approximately +70° to –10°, approximately +50° to –90°, approximately +50° to –70°, approximately +50° to –50°, approximately +50° to –30°, approximately +50° to –10°, approximately +30° to –90°, approximately +30° to –70°, approximately +30° to –50°, approximately +30° to –30°, approximately +30° to –10°, approximately +10° to –9 ... 0° to –70°, about +10° to –50°, about +10° to –30°, about +10° to –10°, 0° to –90°, 0° to –70°, 0° to –50°, 0° to –30°, 0° to –10°, about +90° to 0°, about +90° to +10°, about +90° to +30°, about +90° to +50°, about +90°∘ to +70°, about +70° to 0°, about +70° to +10°, about +70° to +30°, about +70° to +50°, about +50° to 0°, about +50° to +10°, about +50° to +30°, about +30° to 0°, about +30° to +10°, or about +10° to 0°. In some embodiments, the angle is 0°. In some embodiments, the angle is approximately 40°. In some embodiments, the angle is from 0° to approximately 40°. In some embodiments, the angle is from 0° to approximately +90°. In some embodiments, the angle is from 0° to approximately –90°.
[0213] In some embodiments, the end effector is characterized by a gripping angle of 0° to about 90°. In other embodiments, the angle is 0° to about 80°, 0° to about 70°, 0° to about 60°∘, 0° to about 50°, or 0° to about 45°∘. In some embodiments, the angle is 0°. In some embodiments, the angle is about 90°. In some embodiments, the angle is about 0° to about 30°. In some embodiments, the angle is 0° to about 90°. In some embodiments, the end effector is characterized by a rotational motion of about +180° to about -180°. In other embodiments, the angles are approximately +180° to -120°, approximately +180° to approximately -90°, approximately +180° to approximately -30°, approximately +180° to 0°, approximately +180° to approximately +30°, approximately +180° to approximately +90°, approximately +180° to approximately +120°, approximately +120° to approximately +180°, approximately +120° to approximately -120°, approximately +120° to approximately -90°, approximately +120° to approximately -30°, approximately +120° to 0°, approximately +120°∘ to approximately +30°, approximately +120° to approximately +90°, approximately +90°∘ to approximately +180°, approximately +90° to approximately -120°, approximately + 90° to –90°, about +90° to –30°, about +90° to 0°, about +90°∘ to +30°, about +30° to +180°, about +30° to –120°, about +30° to –90°, about +30° to –30°, about +30° to 0°, 0° to –180°, 0° to –120°, 0° to –90°, 0° to –30°, about –30° to –180°, about –30° to –120°, about –30° to –90°, about –90° to –180°, about –−90° to –120°, or about –120° to –180°.
[0214] In some embodiments, the angle is 0°. In some embodiments, the angle is approximately 30°. In some embodiments, the angle is from 0° to approximately 30°. Rotation can be actuated by a torque coil, which is further described below. In some embodiments, the end effector is characterized by a force of approximately 20 N at the chordae tendineae. The force applied to the chordae tendineae can be transmitted through the end effector to provide a gripping force to the end effector. The force can be applied to the chordae tendineae near the actuation system.
[0215] In some embodiments, the end effector is characterized by a wrist force of less than about 0.48 N. The wrist force, related to the wrist of the continuum, is the force exerted by the wrist on the object contacted by the distal end of the arm. To achieve the same wrist force, the force applied to the chordus may vary when the shape of the chordus-sheath mechanism changes. In other embodiments, the force is less than about 0.45 N, about 0.4 N, about 0.35 N, about 0.3 N, about 0.25 N, about 0.2 N, about 0.15 N, or about 0.1 N.
[0216] In some embodiments, the end effector is characterized by a gripping force of less than about 10 N. Gripping force is the force exerted by a gripper-type end effector on a target at the distal end of the arm. In other embodiments, the force is less than about 9 N, about 8 N, about 7 N, about 6 N, about 5 N, about 4 N, about 3 N, about 2 N, about 1 N, about 0.8 N, about 0.5 N, or about 0.3 N.
[0217] In some embodiments, the end effector is characterized by a gripping force of less than about 5 N. In some embodiments, when the arm is parallel to the longitudinal axis of the device, the end effector is characterized by a gripping force of about 0.7 N. In some embodiments, when the end effector is a cutter, the cutter is an electrocautery device or a laser ablation device. The cutter may have a triangular end ( Figure 15A Hook-shaped end ( Figure 15B ) or straight end ( Figure 15C Electrocautery is a process in which direct current or alternating current is passed through resistive metal wire electrodes to generate heat. The heated electrodes are then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction. For example, when a tumor is lifted by a gripper arm to expose its base, a second arm equipped with an electrocautery device can be introduced to cut open the tumor base, including the muscle layer. Figures 4A to 4D If the tumor is large, the position of the resection device can be adjusted, and further tumor resection can continue below the tumor until the entire tumor is removed en bloc. Laser ablation refers to the process of cutting tissue using a laser beam.
[0218] In some embodiments, the electrocautery device is an electrocautery knife. In some embodiments, the ablation module also includes an elongated member proximal to the end effector. This elongated member serves as a base supporting the end effector. The elongated member can be configured to provide additional degrees of freedom of movement to the end effector. For example, one end of the elongated member adjacent to the disc may have a hemispherical shape. The elongated member can be a rigid hollow member. For example, stainless steel can be used. The other end of the elongated member can be connected to a torque coil. The torque coil is a flexible coil that transmits torque control from its distal end to the arm. In this respect, a chord extends from the arm to the distal end of the torque coil. The actuation device can therefore be coupled to the chord extending from the distal end of the torque coil. For example, Figure 35 The ablation module is shown, which includes an arm, an elongated member at the proximal end of the arm, and a torque coil connected to the elongated member.
[0219] The elongated member and the torque coil can have the same diameter and be continuous from one end to the other. Alternatively, the elongated member can have a smaller diameter, while the torque coil has a larger diameter. When the torque coil is designed to be larger, the elongated member can be connected to the torque coil by at least partially inserting into a portion of the torque coil.
[0220] An elongated member can be housed within a housing or guide (or instrument adapter) such that the arm is exposed at one end and the torque coil at the other. The housing can be sized to further accommodate an endoscope. The housing can be manufactured by 3D printing and assembled using stainless steel tubing. In other embodiments, the housing is cast, injection molded, or computer numerically controlled (CNC) machined. The housing facilitates insertion into a flushing sheath and can be further accommodated within the flushing sheath. The housing can be further accommodated within an inner flushing sheath and an outer flushing sheath.
[0221] like Figure 34 As shown, the instrument adapter can be inserted into the irrigation sheath to form an irrigation sheath assembly. This irrigation sheath provides adequate water circulation to ensure safe pressure at the manipulation site (e.g., inside the bladder) and maintains a clear field of vision during device manipulation. This setup allows the resectoscope to be separated from the typically heavier actuation device. Figure 33 As shown, the resection module (or instrument) can be inserted into the irrigation sheath assembly to form a resection scope. This allows the surgeon to easily move the resection scope.
[0222] This disclosure also relates to a resection endoscope including the resection module disclosed herein. In some embodiments, the resection endoscope includes a resection module comprising: a) an end effector located at one end of the resection module; b) a plurality of disks having at least one curved surface, the end effector being movably coupled to the plurality of disks; and c) at least three tendineae passing through the plurality of disks and coupled to the end effector for actuating the end effector.
[0223] In some embodiments, the resection endoscope includes at least two resection modules, the first resection module including: a) a first end effector located at one end of the resection module, the first end effector being a gripper; b) a plurality of discs having at least one curved surface, the first end effector being movably coupled to the plurality of discs; and c) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the first end effector; and the second resection module including: d) a second end effector located at one end of the resection module, the second end effector being a cutter; e) a plurality of discs having at least one curved surface, the second end effector being movably coupled to the plurality of discs; and f) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the second end effector.
[0224] In some embodiments, the resection endoscope includes at least two resection modules, the first resection module including: a) a first end effector located at one end of the resection module, the first end effector being a gripper; b) a plurality of discs having at least one curved surface, the first end effector being movably coupled to the plurality of discs; and c) at least three tendinous cords passing through the plurality of discs and coupled to the end effector for actuating the first end effector; and the second resection module including: d) a second end effector located at one end of the resection module, the second end effector being a snare; e) a plurality of discs having at least one curved surface, the second end effector being movably coupled to the plurality of discs; and f) at least three tendinous cords passing through the plurality of discs and coupled to the end effector for actuating the second end effector. In some embodiments, the resection endoscope includes at least two resection modules, the first resection module including: a) a first end effector located at one end of the resection module, the first end effector being a gripper; b) a plurality of discs having at least one curved surface, the first end effector being movably coupled to the plurality of discs; and c) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the first end effector; and the second resection module including: d) a second end effector located at one end of the resection module, the second end effector being a scissor; e) a plurality of discs having at least one curved surface, the second end effector being movably coupled to the plurality of discs; and f) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the second end effector.
[0225] In some embodiments, the resection endoscope includes at least two resection modules, the first resection module including: a) a first end effector located at one end of the resection module, the first end effector being a gripper; b) a plurality of discs having at least one curved surface, the first end effector being movably coupled to the plurality of discs; and c) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the first end effector; and the second resection module including: d) a second end effector located at one end of the resection module, the second end effector being a coagulation gripper; e) a plurality of discs having at least one curved surface, the second end effector being movably coupled to the plurality of discs; and f) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the second end effector.
[0226] In some embodiments, the resection endoscope includes at least two resection modules, the first resection module including: a) a first end effector located at one end of the resection module, the first end effector being a coagulation gripper; b) a plurality of discs having at least one curved surface, the first end effector being movably coupled to the plurality of discs; and c) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the first end effector; and the second resection module including: d) a second end effector located at one end of the resection module, the second end effector being a cutter; e) a plurality of discs having at least one curved surface, the second end effector being movably coupled to the plurality of discs; and f) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the second end effector.
[0227] In some embodiments, the resection endoscope includes at least two resection modules, the first resection module including: a) a first end effector located at one end of the resection module, the first end effector being a coagulation gripper; b) a plurality of discs having at least one curved surface, the first end effector being movably coupled to the plurality of discs; and c) at least three chordae tendineae passing through the discs and coupled to the end effector for actuating the first end effector; and the second resection module including: d) a second end effector located at one end of the resection module, the second end effector being a snare; e) a plurality of discs having at least one curved surface, the second end effector being movably coupled to the plurality of discs; and f) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the second end effector.
[0228] In some embodiments, the resection endoscope includes at least two resection modules, the first resection module including: a) a first end effector located at one end of the resection module, the first end effector being a coagulation gripper; b) a plurality of discs having at least one curved surface, the first end effector being movably coupled to the plurality of discs; and c) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating the first end effector; and the second resection module including: d) a second end effector located at one end of the resection module, the second end effector being scissors; e) a plurality of discs having at least one curved surface, the second end effector being movably coupled to the plurality of discs; and f) at least three chordae tendineae passing through the plurality of discs and coupled to the end effector for actuating a second arm end effector.
[0229] In some embodiments, the first cutting module includes a first elongated member and a first torque coil, and the second cutting module includes a second elongated member and a second torque coil. In some embodiments, the first and second cutting modules are housed within a housing such that a first and second end effector extend from one end of the housing, and the first and second torque coils extend from the other end of the housing.
[0230] In some embodiments, the resection endoscope includes at least three resection modules, each including: a) an end effector located at one end of the resection module; b) a plurality of discs having at least one curved surface, the end effector being movably coupled to the plurality of discs; and c) at least three tendineae passing through the plurality of discs and coupled to the end effector for actuating the end effector. The resection modules cooperate with each other. Each end effector of each resection module is selected from grippers, coagulation grippers, cutters, snares, traction tools, and scissors.
[0231] In some embodiments, each of the at least three cut-off modules includes an elongated member and a torque coil. In some embodiments, the at least three cut-off modules are housed within a housing such that at least three end effectors extend from one end of the housing and at least three torque coils extend from the other end of the housing.
[0232] In some embodiments, the housing is further housed within an inner flushing sheath and an outer flushing sheath. In some embodiments, the outer sheath is characterized by an outer diameter of approximately 6 mm to approximately 9.3 mm. In other embodiments, the diameter is approximately 6 mm to approximately 9 mm, approximately 7 mm to approximately 9.3 mm, or approximately 7 mm to approximately 9 mm. In some embodiments, the outer sheath is characterized by an outer diameter of approximately 8.7 mm. In some embodiments, the inner sheath is characterized by an outer diameter of approximately 5 mm to approximately 8 mm. In other embodiments, the diameter is approximately 5 mm to approximately 7 mm, approximately 6 mm to approximately 8 mm, or approximately 6 mm to approximately 7 mm. In some embodiments, the inner sheath is characterized by an outer diameter of approximately 7 mm.
[0233] This disclosure also relates to a method for removing a tumor using a resection endoscope as disclosed herein, comprising: a) actuating a first end effector to grasp the tumor; and b) actuating a second end effector to ablate the tumor; wherein the steps of actuating the first and second end effectors include relative displacement and rotation of a plurality of disks having at least one curved surface relative to each other.
[0234] In some embodiments, a method for removing a tumor using a resection endoscope as disclosed herein includes: a) actuating a first end effector to grasp the tumor; b) actuating a second end effector to ablate the tumor; and c) actuating at least a third end effector to cut, hold, or remove the tumor; wherein the step of actuating the end effector includes relative displacement and rotation of a plurality of disks having at least one curved surface relative to each other. The end effectors work in cooperation with each other, and the additional at least third arm can be controlled by another operator.
[0235] The resection endoscope can be inserted into a natural orifice of the body. The resection module or resection endoscope is positioned near the tumor, and the first and second end effectors extend toward the tumor. The surgeon can use the first end effector to grasp and lift the tissue, and then use an electrocautery scalpel (the second end effector) to make an incision and remove the grasped tissue. When the resection is complete, both the first and second end effectors return to an upright position and are removed from the body.
[0236] All examples described herein, whether methods, materials, or products, are provided for illustration and to aid understanding and are not intended to be limiting or exhaustive. Modifications can be made by those skilled in the art without departing from the scope of the claimed invention.
Claims
1. A transurethral resection device, comprising: A housing that defines a channel extending in an axial direction; A gripper assembly disposed in the channel, the gripper assembly being movable relative to the channel along the axial direction, the gripper assembly comprising: A gripper that defines the end of the gripper assembly; A first elongated body defines an axis of the gripper body parallel to the axial direction; and A first continuous joint is coupled between the first elongated body and the gripper, and the first continuous joint can be actuated to displace the gripper relative to the first elongated body. as well as A cutter assembly disposed in the channel, the cutter assembly being movable relative to the channel in the axial direction, the cutter assembly comprising: A cutter that defines the end of the cutter assembly; The second elongated body defines the axis of the cutter body parallel to the axial direction; and A second continuous joint, coupled between the second elongated body and the cutter, is actuable to displace the cutter relative to the second elongated body. The first and second continuous joints can be actuated independently of each other.
2. The transurethral resection device of claim 1, wherein the grasper assembly is actuable to change a first pose of the grasper, the first pose including a first orientation and a first position of the grasper relative to the housing, and wherein the cutter assembly is actuable to change a second pose of the cutter, the second pose including a second orientation and a second position of the cutter relative to the housing.
3. The transurethral resection device as claimed in any of the preceding claims, wherein the first continuous joint is actuable to move the gripper along the gripper plane, and wherein the second continuous joint is actuable to move the cutter in the cutter plane, the cutter plane being orthogonal to the gripper plane.
4. The transurethral resection device of claim 3, wherein the second continuum joint can be actuated to displace the cutter along a sweeping path in the cutter plane.
5. The transurethral resection device of claim 4, wherein the second continuum joint can be actuated to periodically shift the cutter along the sweeping path.
6. The transurethral resection device as claimed in any of the preceding claims, wherein the first continuous joint is actuable to move the gripper within a gripper angular displacement range, and wherein the second continuous joint is actuable to move the cutter within a cutter angular displacement range, and wherein the gripper angular displacement range is greater than the cutter angular displacement range.
7. The transurethral resection device as claimed in any of the preceding claims, wherein each of the first and second continuous joints is capable of bending about its respective two orthogonal axes.
8. The transurethral resection device as claimed in any of the preceding claims, wherein the first continuous joint is actuable to move the gripper away from the axis of the cutter body, and wherein the first continuous joint is actuable to move the gripper toward the axis of the cutter body.
9. The transurethral resection device as claimed in any of the preceding claims, wherein the second continuous joint is actuable to move the cutter away from the axis of the grasper body, and wherein the second continuous joint is actuable to move the cutter toward the axis of the grasper body.
10. The transurethral resection device as claimed in any of the preceding claims, wherein the grasper assembly is rotatable about the axis of the grasper body, and wherein the cutter assembly is rotatable about the axis of the cutter body.
11. The transurethral resection device as claimed in any of the preceding claims, further comprising an endoscope disposed in the passage, the endoscope being positioned adjacent to the grasper assembly and the cutter assembly.
12. The transurethral resection device of claim 11, wherein the endoscope defines an endoscope body axis, wherein the endoscope body axis, the grasper body axis, and the cutter body axis are radially spaced about the axial direction.
13. The transurethral resection device as claimed in any one of claims 9 and 10, wherein the grasper and the cutter are positioned within the field of view of the endoscope.
14. The transurethral resection device as claimed in any of the preceding claims further includes a rotary joint coupled between the second elongated body and the second continuous body joint, wherein the rotary joint is rotatable about a rotation axis to move the cutter and the second continuous body joint together relative to the second elongated body.
15. The transurethral resection device as claimed in any of the preceding claims, wherein the grasper is selected from any of the following: jaw grasper, coagulation grasper, electrocautery forceps, snare, and ring.
16. The transurethral resection device as claimed in any of the preceding claims, wherein the cutter is selected from any of the following: an electrocautery cutter, electrocautery forceps, an ultrasonic scalpel, a surgical laser device, and scissors.
17. The transurethral resection device as claimed in any of the preceding claims, wherein the axis of the grasper body is spaced apart from and parallel to the axis of the cutter body.
18. The transurethral resection device as claimed in any of the preceding claims, wherein each of the first continuous joint and the second continuous joint comprises: Multiple disks stacked and in contact along the axial direction; as well as Multiple tendinous cords passing through each of the plurality of discs, Each of the plurality of disks defines a corresponding disk axis. Each of the plurality of disks includes a first curved surface and an opposing second curved surface, wherein the first curved surface defines a first ridge and the second curved surface defines a second ridge, and the first curved surface and the second curved surface are configured to define an angle between the first ridge and the second ridge.
19. The transurethral resection device of claim 18, wherein for each of the plurality of discs, each of the first ridge and the second ridge is orthogonal to each other and to the respective disc axis.
20. The transurethral resection device of any one of claims 18 and 19, wherein each of the plurality of discs comprises: Multiple first through holes aligned with the first ridge; as well as A plurality of second through holes aligned with the second ridge, wherein each of the plurality of tendineae is tensionable and passes through a corresponding through hole of the plurality of first through holes and the plurality of second through holes.
21. The transurethral resection device as claimed in any one of claims 18 to 20, wherein each of the plurality of discs forms a corresponding line contact with an adjacent disc of the plurality of discs.
22. The transurethral resection device as claimed in any one of claims 18 to 21, wherein a selected line contact among the respective line contacts is displaced in response to a change in tension of at least one of the plurality of chordae tendineae.
23. The transurethral resection device as claimed in any of the preceding claims, wherein the housing maintains the relative orientation between the first elongated body and the second elongated body.
24. The transurethral resection device as claimed in any of the preceding claims, wherein the housing defines a maximum diameter dimension of 7 mm.
25. A transurethral resection system, comprising: A flushing sheath that defines a device channel, the flushing sheath including a flushing inlet path and a flushing outlet path; as well as The transurethral resection device as described in any of the preceding claims, wherein the transurethral resection device is fluid-tightly coupled to the device channel.
26. The transurethral resection system of claim 25, further comprising an actuator operatively coupled to the transurethral resection device, wherein the actuator is a chordae tendineae tensioner configured to actuate the grasper assembly and the cutter assembly.
27. The transurethral resection system of claim 26, further comprising a controller in signal communication with the actuator, wherein the controller controls the actuator to actuate the transurethral resection device.
28. The transurethral resection system of claim 27, further comprising a user interface in signal communication with the controller, the user interface being configured to receive control commands from a user.
29. The transurethral resection system as claimed in any one of claims 25 to 28, configured to perform the following method: The gripper is used to grip the target portion set on the target surface; While holding the target portion using the gripper, the gripper is moved away from the target surface along the gripper plane; and The cutter is moved in a cutter plane to cut between the target portion and the target surface, wherein the cutter plane is orthogonal to the gripper plane.
30. A method of operating a transurethral resection device as claimed in any one of claims 1 to 24, the method comprising: The gripper is used to grip the target portion set on the target surface; While holding the target portion using the gripper, the gripper is moved away from the target surface along the gripper plane; as well as The cutter is moved in a cutter plane to cut between the target portion and the target surface, wherein the cutter plane is orthogonal to the gripper plane.