Surgical instruments for robotic surgery
Patent Information
- Application Number
- JP2023578698
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-06-21
- Filing Date
- 2022-06-16
- Publication Date
- 2025-07-15
- Estimated Expiration
- 2042-06-16
AI Technical Summary
Existing needle holder/cutter type surgical instruments for robotic surgery face challenges in miniaturization, assembly complexity, and precision due to difficulties in manufacturing microridges, microgrooves, and undercuts, as well as the need for robustness under high stresses while minimizing friction.
A needle holder/cutter surgical instrument with an articulated end effector comprising separate parts articulated at a common axis, using a support structure with projections and blade links that rotate together, eliminating elastic preload elements and adjustment screws, and utilizing polymeric tendons to reduce sliding friction.
Enables extreme miniaturization, easy assembly, and precise cutting action with reduced friction, ensuring robustness and reliability under operating conditions.
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Abstract
Description
[Technical field]
[0001] The present invention relates to a needle holder / cutter type surgical instrument.
[0002] The needle holder / cutter surgical instrument of the present invention is particularly suited for application in robotic teleoperated microsurgery.
[0003] The present invention further relates to a robotic surgical system including at least one needle holder / cutter type surgical instrument. [Background technology]
[0004] Robotic surgical devices are generally known in the art and typically include a central robotic tower (or cart) and one or more robotic arms extending from the central robotic tower. Each arm includes a motorized positioning system (or manipulator) for moving a distally mountable surgical instrument to perform a surgical procedure on a patient. The patient typically lies on an operating table located in an operating room, which is ensured to be sterile to avoid bacterial contamination from non-sterile parts of the robotic device.
[0005] In conventional, i.e. non-robotic surgery, needle holder / cutter type instruments are generally known. This type of instrument typically comprises a needle holder / cutter formed by two free ends, at opposite ends of an operating ring, with a gripping surface for a surgical needle and a blade for cutting a suture. In some cases, the blade is made in a seat or recess formed in the body of the gripper and is accessible through a separate access opening different from the opening for accessing the gripping surface of the needle.
[0006] Additionally, in the field of robotic surgery, a laparoscopic needle holder / cutter type end effector solution has been proposed that is located at the distal end of an elongated shaft.
[0007] For example, as shown in US Patent Publication No. 2019-298465, the blades are typically co-molded with the respective gripping surfaces for the needles, which form a cantilever projection relative to the gripping surfaces and are positioned proximally relative to the gripping surfaces, i.e., between the gripping surfaces and the articulating hinges of the gripping surfaces. Thus, a single molded piece typically comprises a root portion for forming part of the hinge, a free end, the gripping surfaces, and the blades extending relative to the gripping surfaces in a closing direction toward the other blade facing the opposite side of the end effector.
[0008] At the hinge, a single washer or multiple elastic washers of the "Belleville washer" type ensure an elastic preload between the roots of the two parts forming the needle holder / cutter type end effector and determine the mechanical interference between the blades for the purpose of performing the cut at closure. Thus, when the end effector closes, the two opposing blades enter an interference at a certain point and a lateral slip occurs between their respective roots, counteracting the elastic influence exerted on the hinge by said elastic Belleville washer.
[0009] Alternatively, US Patent Publication No. 2019-0105032 shows a cutting end effector in which each blade is integrally provided with a resilient cantilever tab, the two said resilient cantilever tabs extending towards each other in a direction parallel to the pin, whereby a resilient preload is provided by the contact between the two cantilever tabs, which avoids assembling a Belleville type resilient washer onto the hinge, thus leaving an axial space in the hinge between the two blades to accommodate sliding against variations in the resilient reaction force exerted by the cantilever resilient tabs in contact with each other.
[0010] In addition to or instead of the "Belleville" type washers, the hinge can be provided with an adjustment screw, which usually forms the articulation pin itself, to adjust the cutting interference between the blades. If an adjustment screw is provided in combination with the "Belleville" type elastic washers, it acts by counteracting the elastic action of the spring and allows the end adjustment of the elastic preload.
[0011] Known solutions usually suggest integrating further functionality, such as electro-thermal cauterization capabilities, into the same end effector by providing electrodes located on the gripping surface, for example the blade of a needle holder / cutter type instrument can be made in a single piece co-molded with the respective free end and gripping surface of the end effector, and the gripping surface itself can be provided with electrical connections constituting the electro-cautery electrode.
[0012] Another known example is given by US Patent Application Publication No. 2020-0107894, which shows a needle holder / cutter solution in which the blade is housed in a longitudinal pocket of the gripping link and is independently rotatable relative to the pocket, thereby allowing the blade to be removed when required.
[0013] Miniaturization of the ends or end effectors of surgical instruments, particularly for robotic surgery, is particularly desirable as it minimizes invasiveness for the patient undergoing surgery while opening up advantageous scenarios where millimeter and sub-millimeter dissection capabilities of tissue can be achieved.
[0014] Known solutions of the aforementioned type are not suitable for further miniaturization, since they impose impossible processes for the manufacture of the parts, as well as complex assembly strategies of the parts to obtain an assembled end effector. One can think, for example, of the necessity to assemble the micro-parts on the hinge while countering the elastic reaction forces of the Belleville type elastic washers, as well as the objective extreme difficulties of manufacture due to the co-molding of micro-ridges and micro-undercuts, which must be robust enough to withstand rather high stresses during operation and at the same time be geometrically shaped to minimize friction. Indeed, as is well known, at the microscale, surface forces such as friction dominate over volume forces.
[0015] In addition to the difficulties of micro-machining the micro-ridges, micro-grooves, and undercuts, the resilient cantilever tabs obtained within the body of the blade described above in connection with known solutions are also extremely difficult to cut and shape in a precise and reproducible manner on the micro-scale.
[0016] Furthermore, as the scale decreases, it becomes increasingly complex to accurately size the elements that are intended to be formed when the rotary joint is assembled, such as the end effector gripping terminals of a surgical instrument, because small machining uncertainties at the level of the fulcrum result in large inaccuracies in the vicinity of each cantilevered free end located distally relative to the rotary joint. Rotary joints are typically responsible for very delicate micromanipulation of surgical needles, suture wires, and the anatomy of the patient undergoing surgery.
[0017] The provision of leverage devices associated with the blades (a solution known per se in the art) also represents an obstacle to miniaturization when attempting to transmit high closing forces such as to provide a precise cutting action without damaging the working tendons: in addition to the only objective difficulties of manufacturing the parts on a very small scale while proving their robustness under operating conditions, there is also the footprint in the area close to the common axis of rotation of the free ends, and the difficulties of assembly.
[0018] The end effector located distally to the hinge, i.e., the cutting blade and gripping surface, is generally designed to perform extremely precise tasks, while the cutting blade must ensure a precise and clean cutting action.
[0019] Commonly owned U.S. Pat. No. 10,864,051, WO 2017-064301, WO 2019-220407, WO 2019-220408, WO 2019-220409 and U.S. Patent Publication No. 2021-059776 disclose telesurgical robotic surgery systems having one or more surgical instruments controlled by one or more master interfaces. Furthermore, US Patent No. 10582975, EP Patent No. 3586780, WO 2017-064303, WO 2018-189721, WO 2018-189729, US Patent Application Publication No. 2020-0170727 and US Patent Application Publication No. 2020-0170726 of the same applicant disclose various embodiments of surgical instruments suitable for robotic surgery and microsurgery. These types of surgical instruments generally comprise a proximal interface part having an interface adapted to be driven by a robotic manipulator, a shaft and an articulation cuff at the distal end of the shaft. The articulation cuff consists of multiple links that are moved by multiple tendons (or actuation cables). The two distal links have free ends and degrees of freedom to open and close between them, and can be adapted to manipulate needles as well as suture wires forming a needle holder gripper type end effector for telesurgical robotic surgery to perform anastomosis or other surgical procedures.
[0020] For example, WO 2017-064306 of the same applicant shows a surgical instrument in which a tendon for actuating the open and closed degrees of freedom of an articulated end effector link slides on a convex textured sliding surface of the end effector link, while avoiding routing the tendon in a guide groove or channel having a recess, thereby minimizing the cross section of the sliding contact between the tendon and the link, thus reducing sliding friction and facilitating the miniaturization of the articulated end effector while ensuring the high dexterity provided by end effector joints such as pitch and yaw revolute joints.
[0021] Furthermore, WO 2018-189722 of the same applicant discloses a surgical instrument in which a tendon for actuating the open / close degree of freedom of an articulated end effector is wound on a convexly textured sliding surface of an end effector link in addition to sliding on said convexly textured sliding surface, as previously discussed, and presents an arcuate path underlying a particularly large winding angle. Indeed, due to the low sliding friction of the tendon, the tendon can remain in contact with the convexly textured surface of the link over a relatively long, arcuate longitudinal cross section.
[0022] Additionally, commonly owned U.S. Patent Application Publication No. 2021-0106393 discloses several embodiments of tendons made of entangled polymer fibers. The use of polymer tendons allows for reduced sliding friction relative to the use of metal tendons, while proper sizing of the tendons allows for tortuous longitudinal path movement in articulating end effectors. Summary of the Invention [Problem to be solved by the invention]
[0023] There is therefore a strong felt need to provide a needle holder / cutter type surgical instrument solution that is suitable for extreme miniaturization and at the same time is robust, reliable and capable of providing a precise and repeatable cutting action.
[0024] Furthermore, a need is felt to propose a solution for a needle holder / cutter type surgical instrument for telesurgical robotic microsurgery that is simple to assemble, easy to construct, reliable, precise and robust under operating conditions, adapted to allow a desired controlled spatial orientation of the cutting action, for example with respect to the main longitudinal extension of the surgical instrument body, which allows for an easy observation of the surgery.
[0025] It is felt that there is a need to propose a solution that makes it possible to assemble an articulated tip micro-instrument with grip and scissors, that is made up of a minimum number of components and that can be assembled in a non-burdensome, simple and cost-affordable manner, without compromising the slight dexterity of the articulated end effector.
[0026] For the formation of articulated tip microinstruments with grips and pincers, a need is felt to propose a solution that allows micromechanical parts, in particular sharp micromechanical parts, to be manufactured with high geometrical precision and reproducibility.
[0027] The object of the present invention is to obviate the drawbacks mentioned in the background art. [Means for solving the problem]
[0028] This and other objects are achieved by a needle holder / cutter surgical instrument according to claim 1.
[0029] Some advantageous embodiments are the subject matter of the dependent claims.
[0030] According to one aspect of the invention, a needle holder / cutter type surgical instrument for a robotic surgical system comprises an articulating end effector including a support structure including two prongs, a first distal link having an elongated body integral with a first proximal mounting base, a first distal free end and a first gripping surface therebetween, and a second distal link having an elongated body integral with a second proximal mounting base, a second distal free end and a second gripping surface therebetween.
[0031] The articulating end effector further comprises a blade link integrally comprising a third proximal mounting base, a resiliently deformable bending body, and a cutting edge.
[0032] The blade link rotates in unison with the first tip link, which acts as a blade holder link. A reaction engagement may be provided between the blade link and the first tip link, which may be located distal to the cutting edge.
[0033] Additionally, an opposing blade surface is provided which rotates with the second tip link and therefore acts as a reaction link.A further opposing blade link may be provided having an opposing blade link root.
[0034] The opposing blade surface is adapted to abut the cutting edge of the blade link and resiliently bend the blade link in an axial direction such that the cutting edge of the blade link and the opposing blade surface reach mechanical interference contact to effect a cutting action.
[0035] The opposing blade may be sharp and include a cutting edge.
[0036] The support structure, the first tip link, the second tip link and the blade link are separate components that are articulated to one another at a common axis of rotation and define an axial direction that is coincident with or parallel to the common axis of rotation.
[0037] The roots are axially adjacent to each other and articulated to the projections of the support structure to define a revolute joint of the cutting joint, which may be an axially rigid revolute joint in which the joint is not provided with a resilient element and the resilience is provided distal to the revolute joint, i.e. in the blade of the blade link.
[0038] The support structure may be included in a support link made in a single piece.
[0039] The support structure may be integrally formed with the distal end of the rod or shaft of the surgical instrument.
[0040] According to one embodiment, the root part is entirely interposed in the pack between the two protrusions of the support structure, is in direct close contact with them and provides a reaction force against the elastic bending of the blade of the blade link during the cutting action, and is not provided with a preload elastic element in the axial direction and is not provided with an adjustment screw. The first, second and third root parts and the protrusions of the support structure can be provided with respective contact surfaces in twos that contact each other, which contact surfaces face in the axial direction and are all parallel to each other.
[0041] According to one embodiment, the third root portion of the blade link is axially interposed between and in direct close contact with the first root portion of the first tip link and the second root portion of the second tip link, providing a reaction force against the elastic bending of the blade of the blade link during the cutting operation. The definable axial distance between the projections can remain constant in any cutting condition. The first mounting root portion can have a first surface facing axially outward and the second root portion can have a second surface facing axially outward, and it can be seen that the further axial distance between the first surface and the second surface is constant for any cutting condition.
[0042] According to one embodiment, the root portions each comprise a through hole, which may all be axial for receiving an articular pin.
[0043] An opposing blade surface which rotates integrally with the second tip link may be caused to protrude axially to bend the blade link during movement in the open or closed degree of freedom.
[0044] According to one embodiment, the opposing blade surface is a curved convex surface having an axially inwardly facing concave surface.
[0045] According to one embodiment, the blade link body is substantially planar in the undeformed configuration and lies on a definable lying surface, preferably the axially facing blade surface of said blade link being parallel to and aligned with a contact surface of said third root portion of said blade link which is in direct intimate contact with said second root portion of said second tip link.
[0046] The first tip link may, together with a portion thereof, define an axially extending axial deformation seat for receiving elastic bending of the blade of the blade link during a cutting operation. According to one embodiment, the axial deformation seat is axially delimited by a surface of the first tip link facing axially inwardly, preferably parallel to the opposing blade surface.
[0047] According to one embodiment, the second tip is provided with a threaded recess for receiving a suture wire to keep the suture wire in contact with the cutting edge of the blade of the blade link during cut closure.
[0048] According to one embodiment, the first root portion of the first tip link integrally comprises at least a first terminal seat for at least one actuating tendon of the first tip link about said common axis of rotation, and the second root portion of the second tip link integrally comprises at least a second terminal seat for at least one actuating tendon of the second tip link about said common axis of rotation.
[0049] The support structure including the two protrusions can be included in a support link that is articulated to the distal end of the shaft about the proximal rotation axis and integrally includes at least a third terminal seat for at least one actuating tendon of the support link centered on the proximal rotation axis.
[0050] The support link may further include one or more integral convex textured sliding surfaces for the actuating tendons of the first and second tip links.
[0051] Preferably, the definable axial distance between the surface of the one or more convex textured sliding surfaces of the support link and the end seat between the end seats of the first root portion or the second root portion remains constant in any cutting state, preferably also in the gripping state.
[0052] According to one embodiment, the axial elasticity required to perform the cutting action is provided by the blade, the roots being axially packed with a support structure, which counteracts the elastic bending of the blade and prevents axial displacement between the roots.
[0053] The body of the counter-blade of the second tip can be elastically bent axially, preferably axially outward, so that the axial elasticity required to perform the cutting action is provided by the blade and the counter-blade together or separately, for example depending on the opening angle of the tips.
[0054] According to one embodiment, a first antagonistic tendon pair is connected to a first attachment root, e.g., a blade holder link root, to move the cutting edge about the common distal axis of rotation, and a second antagonistic tendon pair is connected to a second root to move the opposing blade about the common distal axis of rotation.
[0055] According to one embodiment, a first mounting root, e.g., a blade holder link root, is integral with at least a first terminal seat for receiving the first antagonistic tendon pair, and a second mounting root is integral with at least a second terminal seat for receiving the second antagonistic tendon pair.
[0056] The first and second antagonistic tendon pairs are adapted to slide longitudinally over the one or more convex ruled surfaces of the connecting link and the one or more convex ruled surfaces of the support link, if a connecting link is provided, and are adapted to wind / unwind without sliding over the respective convex ruled surfaces of the blade holder link root portion, i.e., the first root portion, or the reaction link, i.e., the second root portion, to open / close the blade link and the opposing blade, respectively.
[0057] According to one embodiment, a first cantilevered drag leg extends from a first root portion forming a free end of the first leg and axially defines the first termination seat, and a second cantilevered drag leg extends from a second root portion forming a free end of the second leg and axially defines the second termination seat, the first and second cantilevered legs each including an abutment and a drag wall arranged as an undercut with respect to the respective termination seat acting as drag abutments for the respective tendon terminations. In such a case, a first axial distance between a first cantilever leg and a support structure, e.g., a support link, one or more convex ruled surfaces, is identified, which first distance is constant for any cutting condition, and a second distance in a direction parallel to the common distal axis of rotation between a second cantilever leg and a support structure, e.g., a support link, one or more convex ruled surfaces, is identified, which first distance can be constant for any cutting condition.
[0058] The first distance and the second distance may be equal to each other.
[0059] The first distance and / or the second distance may be zero.
[0060] According to one embodiment, when in the operating state, the overall sliding friction force exchanged between each tendon and all the ruled surfaces of the links on which it slides is much smaller than the tensile force transmitted by the same tendon, achieving the elastic bending deformation of the blade when the opening and closing degrees of freedom are moved during closing to perform the cutting operation. In other words, the sliding friction force of the tendon can be much smaller than the mechanical interference contact friction force between the blade and the opposing blade. For this purpose, the tendons can be made of a polymer material, the links can be made of a metal material, and the convex ruled surfaces with parallel generatrices of the links are smooth, which can reduce the longitudinal sliding friction of the tendons on the links. For example, the ruled surfaces of the links are obtained by wire electroerosion.
[0061] Preferably, all of the convex ruled surfaces of the connecting links, the supporting links, the first root pulley and the second root pulley are free of longitudinal channels, so that the actuating tendons do not slide in the concave channels.
[0062] A third antagonistic pair of tendons may be provided for moving the supporting links about said common proximal axis of rotation relative to the connecting links, the supporting links comprising at least a third termination seat for receiving a tendon termination of said third antagonistic pair of tendons. Preferably, the working tendons of the supporting links of said third pair of antagonist tendons wind / unwind without longitudinal sliding on said one or more convex ruled surfaces of the supporting links, such that the convex ruled surfaces act as pulley surfaces for the working tendons of the third pair of antagonist tendons.
[0063] According to one aspect of the present invention, a rotary joint for a cutting joint of a needle holder / cutter type surgical instrument is provided.
[0064] According to one aspect of the present invention, a robotic surgical system is provided that includes at least one needle holder / cutter type surgical instrument.
[0065] Further features and advantages of the needle holder / cutter type surgical instrument will become apparent from the following description of preferred embodiments, given by way of non-limiting example, with reference to the accompanying drawings (note that references to "one" embodiment in this disclosure do not necessarily refer to the same embodiment, but should be understood as at least one, and further, that for purposes of brevity and reducing the total number of drawings, a given drawing may be used to show features of more than one embodiment, and that not all elements of a drawing are required for a given embodiment). [Brief description of the drawings]
[0066] [Figure 1] An axonometric view of a robotic surgical system according to one embodiment. [Diagram 2] FIG. 1 is an axonometric view of a needle holder / cutter type surgical instrument according to one embodiment. [Diagram 3] FIG. 1 is an axonometric view of a portion of a needle holder / cutter type surgical instrument with an end effector at the distal end of a shaft according to one embodiment, showing a schematic of an actuating tendon; [Figure 4] FIG. 1 is an axonometric view of an end effector of a needle holder / cutter type surgical instrument according to one embodiment, showing a schematic of an actuating tendon; [Figure 5A] 1A-1C are schematic diagrams of an end effector of a needle holder / cutter type surgical instrument in one of two operating configurations according to one embodiment, showing schematic actuation tendons; [Figure 5B] 1A-1D are schematic diagrams of an end effector of a needle holder / cutter type surgical instrument in two operating configurations according to one embodiment, showing schematic actuation tendons; [Figure 6] FIG. 1 is an axonometric view of a portion of an end effector of a needle holder / cutter type surgical instrument according to one embodiment. [Figure 7] Axonometric view of a portion of the end effector from Figure 6, showing the parts in an exploded view. [Figure 8A]FIG. 1 is an axonometric view of a needle holder / cutter type surgical instrument with an end effector at the distal end of a shaft according to one embodiment, showing a schematic of an actuating tendon; [Figure 8B] FIG. 8B is a schematic diagram of the actuating tendon of FIG. 8A showing the end effector; [Figure 9] FIG. 1 is an axonometric view of a needle holder / cutter type surgical instrument with an end effector according to one embodiment, showing a schematic of an actuating tendon; [Figure 10] FIG. 1 is a top view in exploded view of a portion of an end effector of a needle holder / cutter type surgical instrument according to one embodiment; [Figure 11] 11 is a top view of a portion of the end effector of FIG. 10 in a cutting configuration, showing the assembled parts; [Figure 12] Axonometric view of a portion of the end effector in the cutting configuration shown in FIG. [Figure 13A] 11 is a vertical elevation view of a portion of the blade link of the end effector of FIG. [Figure 13B] FIG. 11 is a vertical elevation view of a portion of the blade holder link of the end effector of FIG. 10 according to one embodiment; [Figure 14] 1A-1C are schematic diagrams illustrating the configurations assumed by blades and opposing blade surfaces in various mechanical cutting interference configurations according to one embodiment; [Figure 15A] 12 is a vertical elevation view of the end effector of FIG. 11 from the viewpoint indicated by arrow A. [Figure 15B] A vertical elevation view of the end effector of FIG. 11 from the viewpoint indicated by arrow B. [Figure 16] FIG. 12 is an axonometric view of a portion of the end effector of FIG. 11 in an exploded view. [Figure 17A] 12A-12C are diagrams illustrating a portion of the end effector of FIG. 11 in a possible cutting sequence of the suture wire; [Figure 17B] 12A-12C are diagrams illustrating a portion of the end effector of FIG. 11 in a possible cutting sequence of the suture wire; [Figure 17C] 12A-12C are diagrams illustrating a portion of the end effector of FIG. 11 in a possible cutting sequence of the suture wire; [Figure 18]FIG. 1 is a top view in exploded view of a portion of an end effector of a needle holder / cutter type surgical instrument according to one embodiment; [Figure 19] FIG. 1 is a top view in exploded view of a portion of an end effector of a needle holder / cutter type surgical instrument according to one embodiment; [Figure 20] FIG. 20 illustrates the end effector of FIG. 19 in an assembled configuration in a cutting configuration; [Figure 21] Axonometric view of a portion of the end effector of Figure 19 in the assembled configuration [Figure 22] 20 is a vertical elevation view of the opposing blade links of the end effector of FIG. [Figure 23] FIG. 20 is a vertical elevation view of a portion of the second distal link of the end effector of FIG. [Figure 24] FIG. 20 is an axonometric view of a portion of the end effector of FIG. 19 in an exploded view; [Diagram 25] FIG. 25 is a vertical elevation view of an assembled configuration of a portion of the end effector of FIG. [Figure 26] Electron microscope image showing the blade links and opposing blade links arranged on the face of a 5 euro cent coin [Figure 27] FIG. 1 is a vertical elevation view of a portion of an end effector of a needle holder / cutter type surgical instrument according to one embodiment; [Figure 28A] FIG. 1 is a vertical elevation view of a portion of a first distal link of an end effector of a needle holder / cutter type surgical instrument according to one embodiment; [Figure 28B] 28B is a close-up view of the blade link of FIG. 28A from the perspective indicated by arrow B; [Figure 28C] FIG. 28B is an axonometric view of a detail of a portion of the first tip link shown in FIG. [Figure 29A] FIG. 1 is a vertical elevation view of a blade link according to an embodiment; [Figure 29B] FIG. 1 is a vertical elevation view of an opposed blade link according to an embodiment; [Figure 29C] 29B is a vertical elevation view of a portion of an end effector of a needle holder / cutter type surgical instrument with the blade link of FIG. 29A and the opposing blade link of FIG. 29B in an assembled configuration; [Diagram 30]FIG. 13 is a top view of a cutting configuration of a portion of an end effector of a needle holder / cutter type surgical instrument according to another embodiment; [Diagram 31] Electron micrograph image showing a needle driver / scissor gripper type surgical instrument end effector at the distal end of a shaft according to one embodiment. [Diagram 32] FIG. 1 illustrates a rotary joint in a cutting joint of an articulating end effector of a surgical instrument according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0067] References to "an embodiment" throughout this specification are meant to indicate that a particular feature, structure, or function described in connection with the embodiment is included in at least one embodiment of the invention. Thus, the appearances of "in one embodiment" in various parts of this specification do not necessarily all refer to the same embodiment. Furthermore, certain features, structures, or functions, as illustrated in different figures, may be combined in any suitable manner in one or more embodiments, unless otherwise stated.
[0068] According to a general embodiment, a surgical instrument 1 is provided, said surgical instrument 1 being a needle holder / cutter type (or "needle driver / suture cutter type" according to commonly used terminology) surgical instrument 1.
[0069] The needle holder / cutter type surgical instrument 1 is particularly suited, but not uniquely intended for, robotic surgery and may be connectable to a robotic manipulator 63 with an electric actuator of a robotic surgery system 101, for example as shown in Figure 1. For example, the needle holder / cutter type surgical instrument 1 may be associated with mechanical and manual control and actuation devices.
[0070] The robotic surgical system 101 with said needle holder / cutter type surgical instrument 1 is particularly suited for, but not uniquely intended for, robotic microsurgical operations. The robotic surgical system 101 may be intended for robotic laparoscopic surgery.
[0071] Said surgical instrument 1 of needle holder / cutter type comprises an articulated end effector 9, in other words an articulated terminus 9. According to one embodiment, said surgical instrument 1 of needle holder / cutter type comprises a shaft 7 and said articulated end effector 9 at a distal end 8 of the shaft 7. According to a preferred embodiment, said shaft 7 is a rigid shaft, although it is not necessarily a rigid shaft, for example it may be a bendable shaft and / or an articulated shaft. For example, as shown in FIG. 2, a proximal interface part 61 or a rear end part 61 of the surgical instrument 1 can be provided at a proximal end 62 of the shaft 7 to form an interface with a robot manipulator 63 of a robotic surgery system 101. A sterile barrier can be interposed between the robot manipulator and the proximal interface part 61 of the surgical instrument. For example, said proximal interface part 61 can comprise a set of interface transmission elements for receiving drive movements applied by the robot manipulator 63 and transmitting them to the articulated end effector 9. According to one embodiment, the needle holder / cutter type surgical instrument 1 is removably associated with the robotic manipulator 63 of the robotic surgical system 101 .
[0072] The articulated end effector 9 at the distal end 8 of the shaft 7 may comprise a number of links articulated to one another at one or more revolute joints. The links are movable within the shaft 7 by pairs of antagonistic actuating tendons that extend from the proximal interface 61 to the articulated end effector 9 and terminate in termination seats on at least some of the links of the articulated end effector 9. A pair of actuating tendons of one or more of the antagonistic tendon pairs may consist of a single tendon that forms a round trip path from the proximal interface 61 of the instrument to the links of the articulated end effector of the instrument.
[0073] Not all links forming an articulated end effector 9 are necessarily articulated, i.e., not necessarily movable, relative to the distal end 8 of the shaft 7. For example, the end effector 9 may be a "roll-pitch-yaw" type articulated cuff, according to the terminology widely adopted in the art. For example, the end effector 9 may be a "snake" type articulated end effector 9, i.e., may comprise a number of coplanar and / or non-planar rotational joints.
[0074] The articulated end effector 9 of needle holder / cutter type surgical instrument 1 may comprise a support structure with two prongs 3, 4 with a first prong 3 and a second prong 4 forming a support fork. Preferably, the support fork (or support structure) is made in a single piece, i.e. the two prongs 3, 4 are formed in one piece. According to a preferred embodiment, the articulated end effector 9 comprises a support link 2 with the support fork with the two prongs 3, 4.
[0075] Preferably, the term "link" refers to a body made in a single piece, ie a monobloc body.
[0076] For example, according to the embodiment shown in Fig. 3, the support link 2 with the support fork including said projections 3, 4 is a separate part relative to the shaft 7 and is articulated to the shaft 7 by interposing between the support link 2 and a distal end 8 of the shaft 7 of another connecting link 60. The connecting link 60 is rigidly fixed to the distal end of the shaft 7 by a fixing device 64 (in the illustrated example shown as a pair of fixing pins 64, but the fixing device 64 can alternatively comprise a plug, a rivet, a staple, one or more threaded elements, a coupling profile, etc.) and comprises two projections 60.1, 60.2 articulated to the support link 2 relative to the shaft 7 around a common proximal axis of rotation PP, or pitch axis PP (the term "pitch" is used arbitrarily here and can denote any orientation of the common axis of rotation PP).
[0077] For example, according to the embodiment shown in Figures 8A and 8B, the support link 2 with the support fork including said projections 3, 4 is a separate part with respect to the shaft 7 and is rigidly fixed to the shaft 7 by means of a fixing device 64 (in the example shown a pair of pins), i.e. is not articulated. Thus, in such a case, the projections 3 and 4 are integral with the distal end 8 of the shaft 7.
[0078] For example, according to the embodiment shown in Fig. 9, the support structure or fork including said protrusions 3, 4 is formed integrally with the distal end 8 of the shaft 7. Thus, in such a case, the protrusions 3 and 4 are integral with respect to the distal end 8 of the shaft 7 and the articulated end effector 9 further comprises a distal end 8 of the shaft 7 having two protrusions 3, 4, i.e. for the purposes of the present disclosure, in this embodiment, the distal end 8 of the shaft 7 with the two protrusions 3, 4 is understood as belonging to the articulated end effector 9.
[0079] The articulated end effector 9 of needle holder / cutter type surgical instrument 1 further comprises a first distal link 10 (or blade holder link 10) and a second distal link 20 (or reaction link 20). Preferably, the first distal link 10 and the second distal link 20 each have an elongated body which are constrained to one another at their respective proximal or root portions 11, 21 to rotate about a common axis of rotation YY to form a terminal gripping device of the articulated end effector 9 for gripping a surgical needle.
[0080] Specifically, the body of the first distal link 10 integrally comprises a first proximal attachment root 11, a first free distal end 12 and a first gripping surface 13 therebetween, and the body of the second distal link 20 integrally comprises a second proximal attachment root 21, a second free distal end 22 and a second gripping surface 23 therebetween. A connection 81, 82 of each distal link 10, 20 may be defined between the attachment root 11 or 21 and the respective gripping surface 13, 23. In use, the first gripping surface 13 of the first distal link 10 and the second gripping surface 23 of the second distal link 20 are intended to face each other, face each other when rotating, move in contact with each other and perform a gripping action on, for example, a surgical needle. Each gripping surface 13, 23 may be machined in accordance with known techniques to form ridges and recesses to enhance gripping capabilities.
[0081] Advantageously, the articulated end effector 9 of the needle holder / cutter type surgical instrument 1 further comprises a blade link 30 or blade 30, which comprises integrally a third proximal attachment root 31 and a cutting edge 34. The cutting edge 34 is elastically deformable by bending and can be sharpened, i.e. the cutting edge 34 can be sharpened to have a locally reduced thickness and / or a sharp form of cross section with respect to the thickness of the body of the blade link 30. The provision of the blade 30 allows the articulated end effector 9 of the needle holder / cutter type surgical instrument 1 to perform a useful cutting action for severing a suture wire 6, which can be connected to a surgical needle.
[0082] Preferably, the body of the first tip link 10 and the body of the second tip link 20 each have an elongated form in the longitudinal direction extending from their respective mounting roots to their respective free ends, with their respective gripping surfaces disposed adjacent their respective free ends, and with the root portions 11, 21, 31 of the first tip link 10, the second tip link 20 and the blade link 30 adjacent to one another. At the respective connection portions 81, 82 of the body of the first tip link 10 and the body of the second tip link 20 longitudinally interposed between the respective root portions 11, 21 and the respective gripping surfaces 13, 23, axial and longitudinal seats are provided for receiving the body of the blade link 30 at its cutting edge 34. In other words, the elongated bodies of the first end link 10 and the second end link 20 are adjacent to each other at their respective root portions 11, 21 and respective connection portions 81, 82 and overlap at their respective gripping surfaces 13, 23, while the blade link 30 is adjacent to the root portions 11, 21 of the first end link 10 and the second end link 20 at its root portion 31 and adjacent to the connection portions 81, 82 of the first end link 10 and the second end link 20 and is interposed therebetween.
[0083] According to a preferred embodiment, the root of the blade link 31 is interposed between the roots 11, 21 of the first and second tip links 10, 20. Preferably, the body of the blade link 30 is also elongated in the longitudinal direction and comprises a blade link end 32, which is shortened with respect to the bodies of the first and second tip links 10, 20 and extends substantially longitudinally from the adjacent attachment roots 11, 21 to the gripping surface areas 13, 23 of the first and second tip links 10, 23, i.e. the distal end 32 of the blade 30 extends longitudinally to a level close to the proximal ends of the gripping surfaces 13, 23 of the first and second tip links 10, 20.
[0084] According to one embodiment, the blade link 30 is made by shaping, i.e. cutting, a suitably substantially flat elastic sheet or strip. For example, the elastic sheet or strip can be made of spring steel and shaped by wire electroerosion (WEDM) and / or photoetching and / or laser cutting and / or chemical etching. Preferably, the elastic sheet or strip is sharpened at one edge thereof to form the cutting edge 34 of the blade link 30. The sharpening can be performed by wire electroerosion (WEDM) and / or grinding, for example by stone or diamond grinding. According to one embodiment, the elastic sheet or strip is first shaped by wire electroerosion (WEDM) in a flow step substantially perpendicular to the lying plane of the sheet or strip, and then one or more edges of the shaped sheet or strip are sharpened by wire electroerosion (WEDM) in a flow step not perpendicular to the lying plane of the shaped sheet or strip.
[0085] According to one embodiment, the body of the blade link 30 has a two-dimensional main extension, i.e., a thickness that is substantially reduced relative to the extension on said preferably flat or arched lying surface, said main extension being disposed on a preferably flat or arched lying surface.
[0086] According to one embodiment, the cutting edge 34 of the blade link 30 is substantially straight, preferably with a flat or arcuate lying surface, to avoid providing a concave surface in the lying surface of the body of the blade link 30 .
[0087] Preferably, the thickness of the blade link 30 is significantly smaller than that of the first and second tip links 10 and 20, and is selected so that, when in the operating state, the blade is elastically bendable in a direction transverse to the longitudinal extension of the blade link 30, i.e. in the direction of the thickness. In particular, the blade link 30 must be more bendable than the second tip link 20, and preferably more bendable than the first tip link 10. The flexibility of the blade link 30, and thus of the cutting edge 34 of the blade link 30, is intended in the direction of its thickness, i.e. in a direction perpendicular to the lying surface of the blade link. Such lying surface of the body of the blade link 30 can substantially correspond to the lying surface of the starting metal strip or sheet that is suitably processed to form the blade link 30, but according to a possible embodiment, the body of the blade link 30 is forced to have an arched, i.e. concave structure with a concave surface facing in and out of the lying surface of the starting elastic strip or sheet. In this case, the lying surface of the blade link body is an arched surface.
[0088] It is not necessarily the case that the blade link 30, and thus the cutting edge 34 of the blade link 30, is elastically deformable in the lying plane, i.e., it is not necessarily bendable perpendicular to its thickness.
[0089] The material of the blade link 30 may be a different material than the material of the first tip link 10 and / or the second tip link 20. For example, the blade link 30 may be made of spring steel. For example, the first tip link 10 and the second tip link 20 and the support link 2, if present, may be made of a single metallic material, such as steel. For example, the opposing blade link 40, if present, may be made of spring steel.
[0090] The ratio of the thickness of the blade link 30 at the level of the third root portion 31 of the blade link 30 and / or the body of the blade link 30 (excluding in this evaluation the thickness of the cutting edge 34, which is preferably sharp as described above) to the thickness of the first root portion 11 of the first tip link 10 and / or the second root portion 21 of the second tip link 20 may be between 1 / 5 and 1 / 20. In absolute values, the thickness of the blade link 30 may be between 0.1 mm and 1 mm.
[0091] The support structure including the projections 3, 4 (e.g. the support structure formed by the support link 2 or the distal end 8 of the shaft), the first end link 10, the second end link 20 and the blade link 30 are made of separate parts, and the blade link 30 rotates together with the first end link 10. The first end link 10 therefore functions as a blade holder link. This allows the cutting edge 34 to rotate together with the first gripping surface 13 and the first free end 12 of the first end link 10 and to bend elastically, and the cutting edge 34 can be elastically deformed with respect to the first end link 10 with which it rotates when in an operating state. The elastic deformation of the cutting edge 34 preferably occurs transversely to the longitudinal extension of the elongated body of the first end link 10, i.e. transversely to the direction joining the first proximal attachment root 11 and the first distal free end 12 of the first end link 10, in other words in the thickness direction of the blade link 30.
[0092] Specifically, the first root portion 11 of the first tip link 10, the second root portion 21 of the second tip link 20 and the third root portion 31 of the blade link 30 are articulated to the protrusions 3, 4 of the support structure around the common rotation axis YY that defines the directional degree of freedom between the support structure and the group formed by the first tip link 10, the second tip link 20 and the blade link 30. Thus, a distal rotation joint 502 of the cutting joint is formed. Thus, the common rotation axis YY (or a linear extension thereof) passes through the two protrusions 3, 4 and the first, second and third proximal attachment root portions 11, 21, 31 and can be defined by an articulation pin 5. Furthermore, the first root portion 11 of the first tip link 10, the second root portion 21 of the second tip link 20 and the third root portion 31 of the blade link 30 are articulated to one another about said common rotation axis YY to define a relative opening / closing degree of freedom G (or degree of freedom G) between the second tip link 20 and the group formed by the first tip link 10 and the blade link 30. Thereby, the second free end 22 and the second gripping surface 23 of the second tip link 20 and the group formed by the cutting edge 34 and the first free end 12 of the blade link 30 and the first gripping surface 13 of the first tip link 10 are relatively movable in an opening / closing direction, i.e., in a direction of moving closer to or further away from one another.
[0093] According to one embodiment, the opposed, rotationally facing first and second gripping surfaces 13, 23 act as a closing stroke end of the articulated end effector 9 of the needle holder / cutter type surgical instrument 1.
[0094] The proximal and distal directions (or senses) are understood to refer according to the common meaning of the terms, as indicated by the arrows in FIG. 2. Preferably, for clarity of presentation, an axial direction is defined that coincides with or is parallel to the direction of the common axis of rotation YY. Preferably, for clarity of presentation, an inner axial direction is also defined for the first distal link 10, facing the second distal link 20, and likewise, for the second distal link 20, said inner axial direction is opposite, i.e. facing the first distal end 10. Preferably, for clarity of presentation, the term "radial" refers to a direction substantially perpendicular to and incident on the common axis of rotation YY. Preferably, for clarity of presentation, it also means a longitudinal direction that generally substantially coincides with the direction of extension deployment of the needle holder / cutter type surgical instrument 1, and also coincides locally with the longitudinal extension of the elongated body of the first distal link 10 and / or coincides with the longitudinal extension of the elongated body of the second distal link 20. Preferably, for clarity of expression, the first back side D1 of the first end link 10 and the second back side D2 of the second end link 20 are defined with reference to the relative opening and closing degree of freedom G. The first back side D1 and the second back side D2 face opposite each other, the first gripping side P1 of the first end link 10 is defined such that the first gripping surface 13 is included in the first gripping side P1 of the first end link 10, and the second gripping side P2 of the second end link 20 is defined such that the second gripping surface 23 is included in the second gripping side P2 of the second end link 20, and the first gripping side P1 of the first end link 10 and the second gripping side P2 of the second end link 20 are opposed and are arranged substantially side by side during rotation. The first gripping side P1 and the second gripping side P2 are preferably arranged mainly side by side, but the first gripping surface 13 and the second gripping surface 23 can only come into contact when the opening and closing degree of freedom G is in the closed configuration. In other words, the gripping surfaces 13 and 23 are formed on the inner axial protruding portions of the first gripping side P1 of the first end link 10 and the second gripping side P2 of the second end link 20, respectively.
[0095] As mentioned above, the support structure (e.g. formed by the support link 2 or the distal end 8 of the shaft 7), the first tip link 10, the second tip link 20 and the blade link 30 are formed of separate parts, preferably four separate parts (e.g. the distal end 8 of the shaft 7 comprising four links 2, 10, 20, 30 or three links 10, 20, 30 and two protrusions 3, 4) joined to each other at a common rotation axis YY, i.e. a common rotation axis yaw YY axis, which is constrained to rotate relative to the common rotation axis YY (the term "yaw" is used here arbitrarily and can indicate any orientation of the common rotation axis YY, but according to a preferred embodiment is meant to indicate a common rotation axis yaw YY axis which is non-parallel to the proximal common rotation axis pitch PP axis already mentioned above and which is preferably perpendicular to the proximal common rotation axis pitch PP axis).
[0096] Although further links and further parts can be present in the end effector 9, according to one embodiment the articulated end effector 9 is composed precisely of said four parts, articulated together at said common axis YY and suitably movable by actuation tendons. According to one embodiment the articulated end effector 9 is composed precisely of said four parts, articulated together at said common axis YY and suitably movable by actuation tendons, plus a further part, which is an articulation pin 5, which defines said common axis YY (five parts in total, actuation tendons excluded from the count).
[0097] According to one embodiment, the articulated end effector 9 is precisely composed of three parts articulated to each other at the common axis YY relative to the support structure, plus a further part, which is an articulation pin 5 defining the common axis YY (four parts in total, the actuating tendons being excluded from the count), the three parts being the first end link 10, the second end link 20 and the blade link 30. The actuating tendons can be connected to the first link and to the second link.
[0098] According to one embodiment, the articulated end effector 9 is composed precisely of the four parts (i.e. the four links 2, 10, 20, 30) articulated at the common axis YY, a further part being an articulation pin 5 defining the common axis YY, and a connecting link 60 comprising a shaft 7 articulated to the support link 2 at the proximal common rotation axis pitch PP by a further proximal articulation pin 65 defining the proximal common rotation axis pitch PP axis (seven parts in total, the working tendons being excluded from the count). According to this embodiment, when the common rotation axis pitch PP is non-parallel (preferably perpendicular) to the common rotation axis yaw YY, an articulated cuff can be obtained at the distal end of the shaft 7, where the rotation axis pitch PP is non-parallel to the common rotation axis yaw YY and preferably perpendicular to the common rotation axis yaw YY, providing the articulated cuff with pitch, yaw and gripping degrees of freedom G, the gripping degrees of freedom G adapted to manage gripping and cutting. If the connecting link 60 is formed integrally with the distal end 8 of the shaft 7 (not shown), the articulated end effector 9 will still be comprised of seven parts: the distal end 8 of the shaft 7, the support link 2, the blade link 30, the first tip link 10, the second tip link 20, and the two articulation pins 5, 65.
[0099] A degree of freedom of the roll R, which is integral with the shaft 7 and preferably also with the rear end portion 61, can be provided, for example, such that the entire surgical instrument 1 can be rotated around the longitudinal extension axis XX of the shaft 7.
[0100] As will be appreciated by those skilled in the art, minimizing the number of parts significantly simplifies the assembly of the articulated end effector 9 of the needle holder / cutter type surgical instrument 1 and makes it suitable for extreme miniaturization. In particular, avoiding the provision of elastic preload elements in the axial direction (such as Belleville type elastic washers mounted on the articulation pin 5), i.e. in the direction of the common axis of rotation YY between the projections 3, 4 of the support structure, makes it possible to simplify the assembly of parts and thus facilitate the extreme miniaturization of the articulated end effector 9 and thus of the cross section of the shaft 7 while ensuring sufficient strength and resistance to stresses that may occur under operating conditions.
[0101] More preferably, an opposing blade surface 24 is provided which rotates integrally with the second tip link 20. In other words, the articulated end effector 9 further comprises said opposing blade surface 24 which is rotationally integrated with the second tip link 20. The opposing blade surface 24 is not necessarily formed integrally with the second tip link 20, but according to a preferred embodiment it is formed integrally with said second tip link 20, as shown, for example, in FIG.
[0102] For example, according to the embodiment shown in Figure 21, an opposed blade link 40 is provided which is a separate part relative to the second tip link 20 and can rotate together with the second tip link 20. The opposed blade link 40 comprises the opposed blade surface 24 and a fourth proximal mounting root 41 articulated at the common axis of rotation YY.
[0103] The opposing blade surface 24 is adapted to abut against the cutting edge 34 of the elastically deformable blade link 30, so that the opposing blade surface 24 and the cutting edge 34 of the blade link 30 reach a mechanical interference contact to perform the cutting operation. Preferably, the cutting edge 34 of the blade link 30 is sharpened and is flush with an axially facing blade surface 35 of the blade link 30 arranged axially opposite the opposing blade surface 24. During the cutting operation, at least a part of the blade surface 35 can contact the opposing blade surface 24 and cause friction substantially directly in the opening / closing direction G.
[0104] When the opposing blade surface 24 is formed integrally with the second tip link 20, the opposing blade surface 24 faces in an inner axial direction and is preferably included in the connection portion 82 of the elongated body of the second tip link 20 so as to provide mechanical interference contact with the cutting edge 34 of the blade to effect the cutting action.
[0105] According to a preferred embodiment, the opposing blade surface 24, which rotates integrally with the second tip link 20, protrudes towards the rotation footprint of the body of the blade link 30 so as to elastically bend the blade link 30 when it comes into mechanical interference contact with the cutting edge 34. In other words, the opposing blade surface 24 protrudes in the inner axial direction. Said protrusion of the opposing blade surface 24 is accentuated towards the distal direction, i.e. away from the common axis of rotation YY along the longitudinal extension of the second tip link 20, preferably said protrusion being maximum near or at the distal end 32 of the blade link 30. According to a preferred embodiment, the protrusion of the opposing blade surface 24 is obtained gradually by tracing the opposing blade surface in the distal direction, for example with progressively more distal parts having enhanced protrusion.
[0106] Thus, according to one embodiment, the first tip link 10 comprises an axially inward surface 18 inclined away from the body of the blade link body 30 and defines, axially inside, an axial deformation recess 14 (or deformation seat 14) adapted to accommodate the body of the blade link 30 when elastically bent by the action of a projecting opposing blade surface 24 which rotates together with said second tip link 20 during a cutting operation. Thus, both the opposing blade surface 24 and the axially inward surface 18 face the blade link 30 and both come into contact with the blade link 30 during a cutting operation. The axially inward surface 18 preferably belongs to said connection portion 81 of the elongated body of the first tip link 10.
[0107] Preferably, the axially inward facing surface 18 of the first tip link 10 serves as an axial stroke end abutment surface for deformation of the blade link 30 when deformed by bending by the opposing blade surface 24 during a cutting operation. The contours of the protruding surface of the opposing blade 24 and the axially facing surface 18 of the first tip link 10 may be parallel to one another and in one embodiment may be correspondingly identical.
[0108] Preferably, the term "rotational approach footprint" is meant to indicate the volume of space that the body of the element can occupy during the relative closing rotational movement of the gripping degree of freedom G. Thus, the term "rotational approach footprint of the blade link 30" is meant to indicate the volume of space that can be occupied by the body of the blade link 30 during the relative closing rotational movement of the gripping degree of freedom G. Similarly, the "rotational approach dimension of the first link of the tip 10" is meant to indicate the volume of space that can be occupied by the gripping side P1 of the body of the first tip link 10 during the relative closing rotational movement of the gripping degree of freedom G, and the "rotational approach dimension of the second tip link 20" is meant to indicate the volume of space that can be occupied by the gripping side P2 of the body of the second tip link 20 during the relative closing rotational movement of the gripping degree of freedom G.
[0109] The mechanical interference contact between the cutting edge 34 and the opposing blade surface 24, which determines the cutting action, simultaneously causes a bending deformation of the body of the blade link 30. The bending deformation of the body of the blade link 30 during the cutting action is preferably directed axially towards the axially inward surface 18 of the first tip link 10. The bending deformation of the body of the blade link 30 during the cutting action is, for example, directed substantially parallel to the common axis of rotation YY.
[0110] At least one contact point POC between the cutting edge 34 and the opposing blade surface 24 preferably changes in position and / or size as a function of the opening angle of the grip open / close degree of freedom G, as shown, for example, diagrammatically in Fig. 14. In particular, at relatively large opening angles (e.g., angles in the range of 20°-30°), the contact occurs at a more proximal portion of the cutting edge 34, i.e., closer to the third attachment root 31, and as the contact moves distally, the opening angle gradually decreases, enhancing bending due to elastic deformation of the body of the blade link 30 relative to the third root 31 of the blade link 30. Thus, the deformed configuration of the blade link 30 when the first tip link 10 and the second tip link 20 are in a substantially closed configuration is maximally bent, and in any event is bent more than the deformed configuration of the blade link 30 when the first link tip 10 and the second tip link 20 are in a partially closed and partially open configuration. Preferably, when the opening angle is maximum and the blade is free, the blade is straight and the blade link has a substantially planar configuration.
[0111] In order to activate the degrees of freedom of the articulated end effector 9 by moving the links of the articulated end effector 9 about the proximal common axis and / or the distal rotational common axis, i.e., pitch PP and / or yaw YY, the needle holder / cutter type surgical instrument 1 preferably comprises multiple pairs of antagonistic actuating tendons extending from the rear end portion 61 through the shaft 9 to the articulated end effector 9 and terminating in at least a portion of the links of the articulated end effector 9, as described below.
[0112] According to a preferred embodiment, the first tip link 10 is provided with a first end seat 15 for receiving a first antagonistic tendon pair 71, 72, and the second tip link 20 is provided with a second end seat 25 for receiving a second antagonistic tendon pair 73, 74. As will be appreciated by those skilled in the art, in this preferred embodiment, the first and second antagonistic tendon pairs each comprise an open actuation tendon 71, 73 and a closed actuation tendon 72, 74. By forming the end seats 15, 25 integrally with the respective tip links 10, 20, the number of parts can be kept small, facilitating assembly and facilitating compactness. Furthermore, the third root portion 31 of the blade link 30 can be made very thin, or at least thin, as a bendable portion, elastically simplifying the creation of the blade link 30 and at the same time allowing precise characterization of its mechanical properties as they function in the cutting action. Furthermore, according to a preferred embodiment, each end seat 15, 25 serves as an end seat for two antagonistic tendons in each pair of antagonistic tendons, helping to keep the number of movements to be made for each of the tip links 10, 20 to a minimum, thus facilitating compactness. Thus, the third blade link 30 does not have an end seat and is dragged in rotation by the first tip link 10. If a fourth link 40 is present, it is dragged in rotation by the second tip link 20 and does not have an end seat. This allows the number of working tendons to be kept small, and the number of end seats to be kept to a minimum, thus facilitating compactness.
[0113] According to one embodiment, the first end seat 15 of the first end link 10 and the second end seat 25 of the second end link are each defined by a cantilever drag leg 77, 78 extending longitudinally from the respective root portion 11, 21 adjacent the elongate body of the respective end link 10, 20, in particular adjacent the respective link portion 81, 82. Thus, each end seat 15, 25 of the first and second end link 10, 20 is a substantially radial slot, preferably a longitudinal slot, having a radially facing bottom wall formed by the respective mounting root 11, 21.
[0114] Preferably, the extension of the cantilever drag legs 77, 78 between the back side D1, D2 and the cut side P1, P2 of the respective tips 10, 20 is substantially the same, facing the edge surface of the respective termination seat 15, 25. The termination seats 15, 25 are arranged side by side at the same height and act as stop and reaction abutments for the respective tendon terminations 70 of each working tendon 71, 72, 73, 74 of the respective pair of antagonist tendons. The tendon terminations 70 of each working tendon can be, for example, enlarged portions formed by knots or bosses abutting said edge walls of the respective termination seats 15, 25. In other words, said edge wall of each termination seat 15, 25 comprises an edge wall formed by the respective cantilever drag leg 77, 78 and by the respective connection part 81, 82, facing the respective back side D1, D2 acting as a closed resistance edge wall, and an edge wall facing the opposite side of the same respective cantilever drag leg 77, 78, i.e. facing the respective gripping side P1, P2 acting as an open resistance edge wall. The edge wall of the termination seat 15, 25 is thus arranged as an undercut for the respective tendon termination 70 of the respective termination seat 15, 25, each termination seat 15, 25 being a through termination seat, preferably having an access opening facing longitudinally towards the free end 12, 22 of the respective tip link 10, 20. Therefore, the distal portions of each working tendon 71, 72, 73, 74 of the first antagonistic tendon pair and the second antagonistic tendon pair cross and / or overlap within their respective end seats 15, 25, abutting their respective tendon ends 70 against edge walls arranged circumferentially undercut therewith, providing a resistance to the rotation of the first end link 10 or the second end link 20 in the opening and / or closing directions of the opening and closing degree of freedom G.
[0115] According to a preferred embodiment, the first root portion 11 of the first end link 10 and the second root portion 21 of the second end link 20 each comprise at least one pulley surface 79, 80 facing in the opposite direction relative to the common axis of rotation YY, which pulley surface facing in the opposite direction relative to the common axis of rotation YY can wrap around the respective reaction seat 15, 25 from the opposite circumferential direction and continue in the respective end seat 15, 25 facing in the radial direction thereof, i.e. form a bottom wall facing in the opposite direction relative to the common axis of rotation YY. As a result, the distal parts of the tendons 71, 72, 73, 74 of the first and second antagonistic tendon pairs, close to the respective tendon end 70, wrap around the at least one pulley surface 79, 80, which is a convex ruled surface having a generatrix parallel to the axis of rotation YY.
[0116] According to a preferred embodiment, the at least one pulley surface 79 of the first root portion 11 and the at least one pulley surface 80 of the second root portion 21 are all convex ruled surfaces with parallel generatrices and parallel to the common axis of rotation YY, without any circumferential channels or grooves for guiding or retaining tendons. The at least one pulley surface 79, 80, if present, may be interrupted by radially cut channels 19, 29.
[0117] According to an embodiment in which said support link 2 is provided articulated to the distal end 8 of the shaft 7, the needle holder / cutter type surgical instrument 1 further comprises a third antagonistic tendon pair 75, 76 for moving the support link 2 around said common proximal axis of rotation PP. The support link 2 can thus comprise at least a third end seat 67 for receiving the tendon terminal end 70 of the third antagonistic tendon pair 75, 76. For example, according to the embodiment shown in Figures 3 and 4, said at least a third end seat 67 of the support link 2 is a single end seat passing directly axially through the body of the support link 2, i.e. parallel to the common distal axis of rotation YY, forming an abutment wall and a reaction wall for the tendon terminal end 70 arranged as an undercut for each working tendon 75, 76 of the third antagonistic tendon pair, similar to what has been described above with reference to the first end seat 15 and the second end seat 25. According to one embodiment, the support link 2 comprises two separate third end seats 67, one seat for each tendon 75, 76 of the third antagonistic tendon pair.
[0118] According to a preferred embodiment, the support link 2 has parallel generatrices and comprises one or more convex ruled surfaces 84, 86 all parallel to a common proximal axis of rotation PP, on which the working tendons 71, 72, 73, 74 of the first and second antagonistic tendon pairs slide during actuation of the first and / or second end link 10, 20, and the one or more convex ruled surfaces 84, 86 of the support link 2 do not include guide channels or grooves for receiving and guiding the tendons. The support link 2 can also comprise one or more convex ruled surfaces parallel to a common distal axis of rotation YY (not shown) on which the working tendons 71, 72, 73, 74 of the first and second antagonistic tendon pairs slide during actuation of the first and / or second end link 20.
[0119] The same one or more convex ruled surfaces 84, 86 having parallel generatrices and all parallel to the common proximal axis of rotation PP of the support link 2 can also act as pulley surfaces for the working tendons 75, 76 of the third antagonistic tendon pair, the support link 2 being articulated to the distal end 8 of the shaft 7 about the common proximal axis of rotation PP. Said one or more convex ruled surfaces 84, 86 of the support link 2 extend on both sides of the support link 2. According to one embodiment, the pulley surfaces for the working tendons 75, 76 of the third antagonistic tendon pair are formed by the inner surface of the end seat 67 of the support link 2.
[0120] According to the embodiment in which the connection link 60 is provided, the connection link 60 has parallel generatrices and comprises one or more convex ruled surfaces 85, 87 all parallel to a common proximal rotation axis PP, and the working tendons 71, 72, 73, 74, 75, 76 of the first antagonistic tendon pair, the second antagonistic tendon pair and the third antagonistic tendon pair slide on the one or more convex ruled surfaces 85, 87 of the connection link 60. The one or more convex ruled surfaces 85, 87 of the connecting link 60 extend on both sides of the connecting link 60, and between the connecting link 60 and the supporting link 2, the tendons 71, 72, 73, 74, 75, 76 of the first, second and third antagonistic tendon pairs, respectively, cross each other so as to slide or wrap without sliding on the one or more convex ruled surfaces 84, 86 of the supporting link 2 that face opposite to the ruled surfaces 85, 87 of the connecting link 60 along which they slide proximally. For example, the one or more convex ruled surfaces 84, 86 of the supporting link 2 are interposed between the projections 60.1, 60.2 of the link 60 and are oppositely oriented with respect to the common proximal axis of rotation PP.
[0121] The convex ruled surfaces 75, 76, 84, 85, 86, 87 having parallel generatrices of the links in sliding or winding contact with the tendons 71, 72, 73, 74, 79, 80 are preferably all outer surfaces of each link.
[0122] The actuating tendons 71, 72, 73, 74, 75, 76 are preferably polymeric tendons formed by intertwined polymeric fibers.
[0123] According to a preferred embodiment, the group formed by the first root portion 11 of the first tip link 10, the second root portion 21 of the second tip link 20 and the third root portion 31 of the blade link 30 is entirely interposed between the two projections 3, 4 of the support structure and in direct contact with the two projections 3, 4. This avoids relative movements between the root portions and between each root portion and the projection, and therefore, if an articulation pin 5 is provided, relative sliding along the articulation pin 5 between the root portion and the projection is avoided during the elastic deformation of the blade link 30. In other words, the root portions and the projections are preferably arranged side by side and in direct contact with each other, without any elastic reaction forces between them, even at the distal side, i.e. at a given longitudinal distance with respect to the common axis of rotation YY, allowing the rotational approach dimensions of the respective links to overlap or interfere, depending on the geometry of the respective links. For example, a gripping contact occurs between a first gripping surface 13 of the first tip link 10 and a second gripping surface 23 of the second tip link 20. Similarly, a cutting interference contact occurs between a cutting edge 34 of the blade link 30 and an opposing blade surface 24 which rotates with the second tip link 20.
[0124] Similarly, the opposing blade surface 24 can, in an elastically deformed configuration, at least partially overlap with the rotational proximity footprints of the body of the first tip link 10 and the body of the blade link 30 when translated locally relative to the rotational footprint of the first tip link 10 in a direction transverse to the longitudinal extension of the body of the first tip link 10. However, according to a preferred embodiment, the opposing blade surface 24 and the axially inwardly facing surface 18 of the first tip link 10 are geometrically shaped so as not to overlap in their respective rotational footprints.
[0125] According to one embodiment, when there is an opposing blade surface 24 made in a separate piece relative to the second tip link 20 and belonging to an opposing blade link 40 having in particular a fourth proximal mounting root portion 41, the group formed by the first root portion 11 of the first tip link 10 and the second root portion 21 of the second tip link 20, as well as the third root portion 31 of the blade link 30 and the fourth root portion 41 of the opposing blade link 40, is as a whole interposed between the two projections 3, 4 of the support structure and is in direct close contact with them.
[0126] This packaging arrangement of the roots provides a counter force to the elastic bending of the blade body during the cutting action and avoids the need for elastic elements between the roots, thereby simplifying assembly and facilitating extreme compactness.
[0127] Such a packing arrangement of the root parts avoids a collision of the preferably thinner third root part 31 of the blade link 30 against the articulation pin 5, thereby providing sufficient precision of positioning of the cutting edge 34 with respect to the opposing blade 24 for each opening angle of the opening / closing degree of freedom G, and thus a very high cutting accuracy. Similarly, this can also be applied to the fourth root part 41 of the opposing blade link 40, if the opposing blade link 40 is provided.
[0128] Thus, the distal rotation joint 502 may be axially stiff, ie, axially stiff in the direction of the axis of rotation YY.
[0129] According to one embodiment, as shown diagrammatically in Figures 5A and 5B, the actuating tendons 71, 72, 73, 74 of the antagonistic tendon pair are adapted to actuate the distal revolute joint 502 of the end effector 9 and to slide longitudinally on one or more convex ruled surfaces 85, 87 of the connecting link 60 and on one or more convex ruled surfaces 84, 86 of the supporting link 2. In other words, the sliding of the actuating tendons on the ruled surfaces occurs in the longitudinal extension direction of the tendons themselves 71, 72, 73, 74. The path of each tendon 71, 72, 73, 74 is stationary with respect to the convex ruled surface on which it slides, i.e. each tendon slides longitudinally but not axially, and the longitudinal extension direction of each tendon does not change in any operating state. In addition, preferably, the actuating tendons 71, 72, 73, 74 of the antagonistic tendon pair adapted to actuate the distal rotation joint 502 of the end effector 9 include tendons 71, 72 of a first antagonistic tendon pair terminating on the root portion 11 of the first tip link 10 and tendons 73, 74 of a second antagonistic tendon pair terminating on the root portion 21 of the second tip link, wherein the tendons 71, 72 of the first antagonistic tendon pair wind without sliding in the longitudinal direction on a pulley surface 79 formed by one or more convex ruled surfaces 79 having a generatrix parallel to the distal rotation axis YY, and the tendons 73, 74 of the second antagonistic tendon pair wind without sliding in the longitudinal direction on a pulley surface 80 formed by one or more convex ruled surfaces 80 having a generatrix parallel to the distal rotation axis YY.
[0130] On the other hand, the convex ruled surfaces 85, 87 of the connecting link 60 and the convex ruled surfaces 84, 86 of the supporting link 2 do not include guide channels or grooves for holding the tendons in the guide grooves. The geometric relationship between the end seats 15, 25 of the tendons 71, 72, 73, 74 and the ruled surfaces 79, 80, 84, 85, 86, 87 on which the working tendons of the distal revolute joint 502 slide longitudinally or wrap around without sliding is favorable for the constancy of the path of each tendon, even in the absence of guide channels or grooves in the bodies of the links of the end effector 9. Furthermore, the absence of guide channels or grooves for guiding the tendons allows the sliding friction to be minimized while minimizing the contact surface between the cross section of each tendon and the convex ruled surface on which it slides.
[0131] According to one embodiment, as shown diagrammatically in Figures 5A and 5B, the antagonistic actuating tendons 75, 76 adapted to actuate the proximal revolute joint 509 of the articulated end effector 9 terminate on the support link 2 and do not slide longitudinally relative to it, i.e. do not slide longitudinally on said one or more ruled surfaces 84, 86 of the support link 2, but wrap around them without sliding, while they slide longitudinally on said one or more ruled surfaces 85, 87 of the link 60 to move the proximal revolute joint 509. Preferably, the body of the support link 2 integrally comprises at least a third end seat 67 for receiving the actuating tendons 75, 76 of the third antagonistic tendon pair. The longitudinal extension of the tendons is therefore locally perpendicular to the line generating the ruled surfaces with which they are locally in contact.
[0132] The distal rotary joint 502 can cause the cutting action. The cutting edge 34 of the blade link 30 is adapted to abut against said opposing blade surface 24 which rotates together with the second tip link 10 while the degree of freedom G moves in mechanical interference contact to perform the cutting action. Thus, the axial elasticity for obtaining the cutting action is at least partially provided by the elasticity of the blade link 30, whereas the distal rotary joint 502 to which the third root part 31 of the blade link 30 is articulated is axially rigid, i.e. it is not elastically loaded, since relative displacement between the projections 3, 4 and the root parts 11, 21, 31 on the distal rotation axis YY is avoided.
[0133] Preferably, the axial distance Y5 between the first end seat 15 of the root portion 11 of the first tip link 10 and the surface 84 of the one or more convex ruled surfaces 84, 86 of the support link 2 in a direction parallel to the common distal rotation axis YY is constant for any cutting state. Similarly, the axial distance Y5' between the second end seat 25 of the root portion 21 of the second tip link 20 and the surface 86 of the one or more convex ruled surfaces 84, 86 of the support link 2 in a direction parallel to the common distal rotation axis YY is constant for any cutting state. That is, when the opening angle of the opening / closing degree of freedom G changes, the axial distances Y5, Y5' between the convex ruled surfaces 84, 86 of the support link 2 and the end seats 15, 25 of the first or second pair of tendons 71, 72, 73, 74 remain the same.
[0134] According to one embodiment, the first distance Y5 is 0, i.e. the end seat 15 is longitudinally aligned with the convex ruled surface 84 of the support link 2. In such a case, the actuating tendons 71, 72 of the first tip link 10 can have their respective distal paths parallel to each other. Similarly, according to one embodiment, the second distance Y5' is 0, i.e. the end seat 25 is longitudinally aligned with the convex ruled surface 86 of the support link 2. In such a case, the actuating tendons 73, 74 of the reaction link 20 can have their respective distal paths parallel to each other.
[0135] According to a preferred embodiment, the axial distance Y5 between the first end seat 15 of the root portion 11 of the link 10 and the surface 84 of the one or more convex ruled surfaces 84, 86 of the support link 2 is equal to the axial distance Y5' between the second end seat 25 of the root portion 21 of the link 20 and the surface 86 of the one or more convex ruled surfaces 84, 86 of the support link 2.
[0136] Thus, axial sliding along the articular pin 5 between the roots and between the roots and the protrusions is avoided, and the tendons 71, 72, 73, 74 of the first or second antagonistic tendon pair slide longitudinally to actuate the opening / closing degree of freedom G. That is, the geometric relationship between the ruled surfaces 84, 86 of the support link 2 performing the cutting action and the terminal seats 15, 25 of the respective tendons made integral with the root 11 of the link 10 or the root 21 of the link 20, respectively, is maintained. This makes it possible to avoid hindering the relative rotation between the links around the distal common rotation axis YY.
[0137] In the direction parallel to the axis of rotation, the tendons do not slide against their respective ruled surfaces.
[0138] It is therefore possible to form an axially rigid rotary joint 502 of the cutting joint. A blade is provided having a cutting edge 34 and an opposing blade surface 24 which rotate together with the axially rigid rotary joint 502 and together can perform the cutting action during the closing action of the opening and closing degree of freedom. It is thus possible to avoid providing a Belleville type elastic element attached to the articulation pin 5 or inserted between the projections 3, 4 of the support structure. Furthermore, it is avoided to provide an adjustment screw adapted to axially clamp the roots together.
[0139] The axially rigid distal rotation joint 502 also allows the cutting edge 34 to be oriented by rotating it about the yaw YY axis of rotation, allowing controlled adjustment of the cutting direction.
[0140] Such a distal revolute joint 502 is also axially rigid with respect to any orientation of the yaw Y degree of freedom, i.e. any movement of the group formed by the first tip link 10, the blade link 30 and the second tip link 20 relative to the support structure, and, if present, with respect to any orientation of the pitch P degree of freedom of the proximal revolute joint 509, i.e. any movement of the group formed by the first tip link 10, the blade link 30 and the second tip link 20 relative to the shaft 7 with respect to the support link 2 and the link 60 of the group formed by the first tip link 10, the blade link 30 and the second tip link 20. Preferably, the connecting link 60 to the shaft is rigidly fixed to the distal end 8 of the shaft 7, for example by a pair of pins 94, in which case the pitch P degree of freedom can be understood as the orientation of the support link 2 relative to the shaft 7, especially when the shaft 7 is a rigid shaft.
[0141] Preferably, the distance between the protrusions 3, 4 of the support structure remains constant for any cutting condition, and the protrusions remain in direct intimate contact with the surfaces of the first root portion 11 and the second root portion 21 respectively.
[0142] Therefore, preferably, the first root portion 11 of the first tip link 10 has a first external contact surface 52, the first protrusion 3 of the support structure has a first internal contact surface 53, said first external contact surface 52 of the first root portion 11 contacting said first internal contact surface 53 of the first protrusion 3, the second root portion 21 of the second tip link 20 has a second external contact surface 55, the second protrusion 4 of the support structure has a second internal contact opposing surface 54, said second external contact surface 55 of the second root portion 21 contacting said second internal contact opposing surface 54 of the second protrusion 4.
[0143] For example, according to the embodiment shown in Fig. 30, the third root portion 31 of the blade link 30 is interposed between the first projection 3 of the support structure and the first root portion 11 of the first end link 10 and is in direct intimate contact therewith. By providing a transverse bridge 33 on the body of the blade link 30 across the rotational approach footprint of the body of the first end link 10, the cutting edge 34 rotates together with the second end link 20, i.e., is in contact with the opposing blade surface 24 between the first end link 10 and the second end link 20. In other words, the transverse bridge 33 can cross the connection portion 81 of the elongated body of the first end link 10 and / or the first root portion 11 of the first end link 10. In such case, the first inner contact surface 51 of the first root portion 11 contacts the second inner contact surface 56 of the second root portion 21, the first outer contact surface 52 of the first root portion 11 contacts the second contact surface 57 of the third root portion 31 and the first contact surface 53 of the first protrusion 3 contacts the first contact surface 58 of the third root portion 31. Thus, according to this embodiment, the blade with the cutting edge 34 remains interposed between the first and second tip links, and the third root portion 31 of the blade link 30 is interposed between the first protrusion 3 of the support structure and the first root portion 11 of the first tip link 10.
[0144] For example, according to a preferred embodiment shown in Fig. 11, the third root portion 31 of the blade link 30 is interposed between the first root portion 11 of the first tip link 10 and the second root portion 21 of the second tip link 20, and is in direct close contact therewith, providing a reaction force against the elastic bending of the blade 34 of the blade link 30 during the cutting operation. Due to the contact of the third root portion of the blade link between the first root portion 11 of the first tip link 10 and the second root portion 21 of the second tip link 20, it is determined that during the elastic deformation in the thickness direction of the body of the blade link 30, which is performed from the interference contact between the cutting edge 34 and the opposing blade surface 24, the third root portion 31 of the blade link 30 is not deformed relative to the first root portion 11 and the second root portion 21, since the deformation in the common axis rotation YY direction between the first root portion 11 of the first tip link 10 and the second root portion 21 of the second tip link 20 is constrained.
[0145] Thus, preferably, the first root portion 11 of the first tip link 10 comprises a first inner contact surface 51 and the third root portion 31 of the blade link 30 comprises a first contact surface 58, said first inner contact surface 51 of the first root portion 11 being in contact with the first contact surface 58 of the third root portion 31. The second root portion 21 of the second tip link 20 comprises a second inner contact surface 56 and the third root portion 31 of the blade link 30 comprises a second contact surface 57 or a contact surface facing the opposing blade 57, said second inner contact surface 56 of the second root portion 21 being in contact with said second contact surface 57 of the third root portion 31.
[0146] According to a preferred embodiment, all said contact surfaces of the roots 11, 21, 31 and the protrusions 3, 4 are parallel to each other and preferably all perpendicular to the common rotation axis YY. Preferably, in each configuration of the open / closed degree of freedom G, all said contact surfaces of the roots 11, 21, 31 and the protrusions 3, 4 always remain parallel to each other and in direct close contact with each other.
[0147] According to one embodiment, there is an opposing blade surface 24 made as a separate part for the second tip link 20, in particular belonging to an opposing blade link 40 having a fourth proximal attachment root 41. The third root 31 of the blade link 30 is axially interposed between said first root 11 of the first tip link 10 and said fourth root 41 of the opposing blade link 40, and is in direct contact therewith, and the fourth root 41 of the opposing blade link 40 is axially interposed between said third root 30 of the blade link 30 and said second root 21 of the second tip link 20, and is in direct contact therewith, providing a reaction force against the elastic bending of the blade of the blade link 30 during the cutting action. Thus, according to this embodiment, the fourth root portion 41 of the opposing blade link 40 has two opposing contact surfaces 59, 66, such that the first, second, third and fourth root portions 11, 21, 31, 41 and the protrusions 3, 4 have respective contact surfaces 51, 52, 53, 54, 55, 56, 57, 58, 59, 66 which rotate axially and are all parallel to each other.
[0148] The root portion preferably has a cylindrical shape centered on the common axis of rotation YY, and the third root portion 31 has a disk-shaped cylindrical shape if the third root portion 31 has a substantially smaller thickness than the first root portion 11 and the second root portion 21. Similarly, this can fit the fourth root portion 41 of the opposing blade link 40, if provided.
[0149] The manufacture of the parts by wire electroerosion process allows to obtain increased tolerances, but provides for a minimum local microclearance of the order of tenths of a millimeter between at least some of said contact surfaces of the roots and / or protrusions in the direction of the common rotation axis YY to ensure direct close contact. At the same time, a relative rotation about the common rotation axis YY can be allowed during actuation of the open / close degree of freedom G and / or the yaw degree of freedom Y. The articulation pin 5 can interfere with at least one of the roots and / or protrusions, i.e. rotate integrally with the roots and / or at least one of the protrusions.
[0150] In particular, the support structure with the two protrusions 3, 4, the first root portion 11 of the first tip link 10, the second root portion 21 of the second tip link 20 and the third root portion 31 of the blade link 30 are made in separate parts, which necessarily involves a minimum microclearance in the axial direction, i.e. in the direction of the common axis of rotation YY between the respective contact surfaces, and said microclearance as a whole is, according to one embodiment, in the range between 1 / 20 and 1 / 5 of the thickness of the third root 31 of the blade link 30, divided, i.e. distributed locally between the contact surfaces of the protrusions 3, 4 and the root portions of the respective links, where the contact surfaces of the protrusions 3, 4 of the first and second tip links 10, respectively, and the contact surfaces of the first and second root portions 11, 21, respectively, are made by wire electroerosion (WEDM).
[0151] The expression "directly in close contact" is therefore also intended to indicate an embodiment in which a minimum microclearance is provided in any case not only between at least a part of the contact surfaces of the projections of the support structure and the roots of the respective links, but between them in their entirety. During the cutting operation, especially at relatively large opening angles of the opening and closing degree of freedom G (for example angles of about 20°-30° between the gripping surfaces 13, 23), the mechanical interference contact between the cutting edge 34 of the blade link 30 and the opposing blade surface 24 can therefore generate a minimum microdisplacement of the order of one hundredth of a millimeter of the third root along the articular pin 5, and also of the fourth root 41, if present.
[0152] For example, as is evident from the analysis carried out by the inventors, according to one embodiment, the thickness of the third root portion 31 of the blade link 30 is about 0.2 mm, the overall microclearance in the direction of the common rotation axis YY in the operative state, locally distributed between the contact surfaces of the protrusions and the root portions of the respective links, is generally about 0.02 mm, and the local microclearance in the direction of the common rotation axis YY between the third root portion 31 of the blade link 30 and the second root portion 21 of the second tip link 20, when in the operative state, is about 0.01 mm, i.e. substantially equal to 1 / 20 of the thickness of the third root portion 31 of the blade link 30.
[0153] The support structure with the two protrusions 3, 4, the first root portion 11 of the first tip link 10, the second root portion 21 of the second tip link 20 and the third root portion 31 of the blade link 30 are made of separate parts imposing a minimum clearance in the direction of the common rotation axis YY as explained above, which allows the opening and closing rotational degree of freedom G to be manipulated in a precise and controlled manner in both the opening and closing directions, while simultaneously performing gripping and / or cutting actions.
[0154] The articulating pin 5 can be made in the form of two oppositely aligned cantilever legs integral with the first root portion 11 of the first end link 10 or in the form of two oppositely aligned cantilever legs integral with the second root portion 21 of the second end link 20. Alternatively, the articulating pin 5 can be made in two parts, the first part being in the form of two oppositely aligned cantilever legs of a single part with the first root portion 11 of the first end link 10 and the second part being in the form of two oppositely aligned cantilever legs of a single part with the second root 21 of the second end link 20, said first and second parts of the articulating pin 5 being aligned along a common axis of rotation YY.
[0155] According to a preferred embodiment, the first root portion 11 of the first distal link 10 comprises a first through hole 16, the second root portion 21 of the second distal link 20 comprises a second through hole 26, and the third root portion 31 of the blade link 30 comprises a third through hole 36, the first through hole 16 of the first root portion 11, the second through hole 26 of the second root portion 21 and the third through hole 36 of the third root portion 31 being axially aligned with the common axis of rotation YY. According to an embodiment, an articulating pin 5 is received inside the first, second and third through holes 16, 26, 36. In this case, said articulating pin 5 can be made as a single cantilever leg with one of the projections 3, 4 of the support structure, or it can be made as two parts in the form of two oppositely aligned cantilever legs, each of the two parts being a single part with one of the projections 3, 4 of the support structure. However, according to a preferred embodiment, the articulating pin 5 is a separate part with respect to the root 11, 21, 31 and also with respect to the projections 3, 4. According to an embodiment, each of the two projections 3, 4 is axially aligned with said common axis of rotation YY and comprises a through-hole of the projection 165 aligned with each and all of said first, second and third through-holes 16, 26, 26 of the first, second and third root parts 11, 21, 31, respectively.
[0156] According to one embodiment, said first through hole 16 of the first root portion 11, said second through hole 26 of the second root portion 21 and said third through hole 36 of the third root portion 31 are all circular through holes, coaxial with said common axis of rotation YY and receive a single articulating pin 5 extending in the direction of the common axis of rotation YY from a first protrusion of the support structure 3 to a second protrusion of the support structure 4. According to one embodiment, said first through hole 16 of the first root portion 11, said second through hole 26 of the second root portion 21 and said third through hole 36 of the third root portion 31 all have substantially the same diameter and receive said articulating pin 5 in direct close contact over the entire circumferential extension of the respective hole edges 16.1, 26.1, 36.1.
[0157] The provision of said circular third through hole 36 of the third root part 31 of the blade link 30 in direct close contact with the articulation pin 5 over the entire circumferential extension of its hole edge 36.1 makes it possible to provide a counter force against the cutting action exerted by the cutting edge 34 of the blade link 30. In particular, during the cutting action, the opening angle of the gripping degree of freedom G gradually decreases, resulting in a mechanical interference contact between the cutting edge 34 (and preferably also the blade surface 35) of the blade link 30 and the counter blade surface 24 which rotates together with the second tip link 20, so that a direct friction force in the opening direction occurs on the cutting edge 34 (and preferably also the blade surface 35) of the body of the blade link 30 in contact with the counter blade surface 24, which is balanced by a counter force against the friction of the cutting action exchanged in the area of mutual contact between the hole edge 36.1 of the third through hole 36 of the third root part 31 of the blade link 30 and the articulation pin 5. The friction reaction force of the cutting action is preferably directed substantially radially relative to the common axis of rotation YY. The friction reaction force of the cutting action preferably acts on an arcuate surface 38 in the thickness of the hole edge 36.1 of the circular third through hole 36 of the third root portion 31 of the blade link 30 facing the circular through hole 36.
[0158] According to one embodiment, when there is an opposing blade surface 24 made in a separate piece relative to the second tip link 20 and belonging to said opposing blade link 40 in particular having said fourth proximal mounting root portion 41, said fourth root portion 41 of said opposing blade link 40 comprises a fourth through hole 43, and said first through hole 16 of the first root portion 11, said second through hole 26 of the second root portion 21, said third through hole 36 of the third root portion 31 and said fourth through hole 43 of the fourth root portion 41 are all circular through holes, coaxial with said common axis of rotation YY and receive a single articulation pin 5 extending in the direction of the common axis of rotation YY from the first protrusion 3 of the support structure to the second protrusion 4 of the support structure. According to one embodiment, the fourth through hole 43 of the fourth root portion 41 of the opposing blade link 40 has a hole edge 43.1 which is in direct contact with the articulating pin 5 over the entire extension of the hole edge and exerts a reaction force against the friction exchanged between the blade link 30 and the opposing blade surface 24 of the opposing blade link 40 during the cutting operation on a circular arc surface in the thickness of the hole edge.
[0159] In the case where at least some, but also all, of the through holes of the roots are made by wire electroerosion (WEDM), as an effect of successive cutting paths of the cutting wire used to make the through holes by wire electroerosion, radial cut channels 19, 29, 39, 49 are provided in each root between the hole edge and the outer edge of the respective root. Preferably, the arrangement of the radial cut channels on each root is studied based on the static or dynamic behavior of each link when in operation. In particular, according to a preferred embodiment, the cut channel 39 of the root portion 31 of the blade link 30 is radially offset with respect to the cut channel 29 of the second root portion 21 of the second tip link 20 and the cut channel 49 of the fourth root portion 41 of the opposing blade link 40, to prevent the edges of the cut channels from interlocking with each other during opening and closing operations.
[0160] According to one embodiment, the through hole of each protrusion 165 of said two protrusions 3, 4 is a circular through hole coaxial with said common axis of rotation YY. If the protrusions 3, 4 of the support structure are made by wire electroerosion, they can be provided with at least one radial channel between the hole edge and the outer edge of each protrusion.
[0161] According to one embodiment, the opposing blade surface 24 can be configured to be inclined in a direction transverse to, and preferably perpendicular to, the longitudinal extension of the body of the second end link 20, and transverse to, and preferably perpendicular to, the common axis of rotation YY. That is, in other words, the opposing blade surface 24 can be configured to be inclined in a direction that couples the back side D2 with the gripping side P2 of the second end link 20, and is preferably configured to protrude more toward the back side D2. Note that the opposing blade surface 24 does not necessarily have to be inclined even if it protrudes.
[0162] According to one embodiment, said opposing blade surface 24 is a curved surface, which makes it protrude due to its arch shape. The concave surface of the opposing blade surface 24 preferably faces axially and inwardly, i.e. parallel to the common axis of rotation YY and facing the rotation footprint of the blade link 30.
[0163] The opposing blade surface 24 can appropriately bend the cutting edge 34 and the blade link 30 to function as a wedge that exerts a cutting action substantially along the entire longitudinal extension of the opposing blade surface 24 .
[0164] According to one embodiment, the blade link 30 is substantially flat when in an undeformed configuration, i.e. when lying on a definable lying surface. Elastic bending of the blade link 30 tends to return the blade link 30 to said undeformed planar configuration. The axially inwardly facing blade surface 35 is therefore parallel to the second contact surface 57 of the third root portion 31 of the blade link 30, and preferably can also be aligned, for example seamlessly. In other words, according to one embodiment, the definable lying surface of the blade link 30 is parallel to the second contact surface 57 of the third root portion 31 of the blade link 30 and parallel to the first contact surface 58 of the third root portion 31 of the blade link 30. Preferably, the cutting edge 34 is straight when in an undeformed state, i.e. extends substantially linearly as a preferably straight extension parallel to the second contact surface 57 of the third root portion 31 of the blade link 30. In other words, according to one embodiment, the cutting edge 34 extends parallel to a definable lying surface of the blade link 30 .
[0165] The cutting edge 34 of the blade link 30 can be aligned with the longitudinal extension XX of the shaft 7 in at least one operating configuration, for example, when the shaft 7 is a straight, rigid shaft and the cutting edge 34 is not in contact with a protruding portion of the opposing blade surface 24.
[0166] According to one embodiment, a reaction engagement is provided that is located distally relative to the common axis of rotation YY to rotate the blade link 30 together with the first tip link 10. The reaction engagement can be formed along the longitudinal extension of the cutting edge 34 of the blade link 30 (not necessarily by interrupting the cutting edge 34), and is preferably formed adjacent to or at the distal end of the cutting edge 34 of the blade link 30. The reaction engagement can be obtained by engagement of the blade link 30 with the first tip link 10.
[0167] According to one embodiment, the first tip link 10 comprises at least one reaction surface 17.1, 17.2 for pulling the blade link 30 into a ration, preferably an open reaction surface 17.2 and a closed reaction surface 17.1. According to one embodiment, the at least one reaction surface 17.1, 17.2 of the first tip link 10 defines a reaction seat 17 for receiving a reaction portion of the blade link 30 to rotate together with the blade link 30 and the first tip link 10. In this case, the at least one reaction surface 17.1, 17.2 of the first tip link 10 comprises two opposing reaction counter surfaces 17.1, 17.2, which interface with two opposing reaction counter surfaces 37.1, 37.2 of the blade link 30 to rotate the blade link 30 in both the opening and closing directions of the opening and closing degree of freedom G. In such a case, to achieve a more favorable mechanical transmission, the reaction portion of the blade link 30 can be located at the third root portion 31, but to ensure accurate reaction, it is preferred that the reaction portion of the blade link 30 is located away from the third root portion 31 of the blade link 30. The open reaction face 37.2 and the closed reaction face 37.1 of the blade link 30 can be located on a single portion, for example as opposing faces of a single protrusion that may coincide with the distal end 32 of the blade link 30.
[0168] According to one embodiment, the reaction part of the blade link 30 coincides with the distal end 32 of the blade link 30, and the reaction seat 17 of the first tip link 10 is located distal to the axially inward surface 18 of the first tip link 10, i.e. to a surface that can act as an abutment for the deformation of the blade. In such a case, the reaction seat 17 has an axial extension to receive the distal end 32 of the blade link 30, and therefore receives the deformation of the blade link 30 during the cutting operation together with said deformation seat 14. The distal end 32 of the blade link 30 can include a distal portion of said cutting edge 34, which in such a case acts as a reaction counter surface in the opening direction 37.2 cooperating with the opening reaction surface 17.2 of each of the first blade link 10. According to one embodiment, proximally relative to the first gripping surface 13, a reaction tooth 17.0 extends proximally, i.e., toward the common axis of rotation YY, opens proximally and forms an undercut seat relative to the axially extending first gripping surface 13, forming a reaction seat 17 that receives the distal end 32 of the blade link 30.
[0169] According to an embodiment in which the reaction portion of the blade link 30 coincides with the distal end 32 of the blade link 30, said distal end 32 of the blade link 30 is constrained to rotate with the first tip link 10 and is free to slide axially relative to the tip link 10 within the reaction seat 17 during elastic bending deformation during the cutting operation.
[0170] The open drag facing surface 37.2 and the closed drag facing surface 37.1 of the blade link 30 may be located at different distances from the common axis of rotation YY, for example at different protrusions of the blade link 30, as shown in Fig. 28A. With particular reference to Figs. 28A, 28B and 28C, as well as Fig. 29A, the third root portion 31 of the blade link 30 may comprise a radial drag ear 37 folded onto the first root portion 11 of the first tip link 10, said drag ear 37 including said open drag facing surface 37.2 in drag contact with an open drag surface 17.2 located, for example, on a part of the rear D1 of the connection portion 81 of the body of the first tip link 10.
[0171] According to one embodiment, the first tip link 10 and the blade link 30, which are made of separate parts, rotate together in a releasable manner, and release can preferably only be achieved by disassembling the articulated end effector 9.
[0172] According to an alternative embodiment, which may not necessarily be combined with all embodiments described herein, as shown in Fig. 18, for example, the blade 30 is made integral with the first tip link 10, thereby defining the blade 30 having a cutting edge 34 extending in the longitudinal direction and cantilevered from the first root portion 11 of the first tip link 10. In particular, in this alternative, the third root portion 31 of the blade link 30 and the first root portion 11 of the first tip link 10 are formed integrally, and the blade body having said cutting edge 34 cantilevered from the root portion of the first tip link 10 adjacent the connection portion 81 of the first tip link 10. Thus, in this alternative, the first inner contact surface 51 of the first root portion 11 of the first tip link 10 is in direct intimate contact with the second inner contact surface 56 of the second root portion 21 of the second tip link 20, and the cutting edge 34 and the blade surface 35 of the blade 30 may be aligned with said first inner contact surface 51. This alternative may be combined with any embodiment of the opposing blade surface 24 described herein, for example, the opposing blade surface 24 may be made integral with the second tip link 20 or in a separate piece to provide the opposing blade link 40.
[0173] According to one embodiment, the second distal link 20 comprises a threaded wall 28 facing the common axis of rotation YY, which threaded wall defines a threaded recess 28.1 for receiving the suture wire 6 and maintaining it in contact with the cutting edge 34 of the blade of the blade link 30 during cutting closure. The provision of the threaded wall 28 prevents the suture wire 6 from sliding distally over the distal end 32 of the blade during the cutting movement as an effect of the closing movement.
[0174] The screwing wall 28 and the screwing recess 28.1 preferably face the gripping side P2 of the second end link 20, for example the screwing wall 28 is an arched wall having a concave surface defining the recess 28.1 facing the gripping side P2 of the second end link 20. The recess 28.1 can be made in the form of a notch in the body of the second end link 20, in which case the screwing wall 28 is the wall defining said notch. The recess 28.1 can be made in the form of an undercut wall in a protruding part of the body of the second end link 20, in which case the screwing wall 28 is the undercut wall of said protruding part facing the common axis of rotation YY.
[0175] According to one embodiment, the screw-on wall 28 defines, at its axially inner edge, the opposing blade surface 24 from the gripping side P2 of the second tip link 20. If the opposing blade surface 24 is made in a separate piece to the second tip link 20, the screw-on wall 28 and the recess 28.1 can be formed in the body of the opposing blade link 40.
[0176] As mentioned above, according to one embodiment, the second tip link 20 comprises the opposing blade surface 24 in one piece. Alternatively, as mentioned above, the opposing blade link 40 can be provided in a separate part relative to the second tip link 20 and rotate together therewith, the opposing blade link 40 comprising the opposing blade surface 24 and a fourth proximal attachment root 41 articulated in the common axis of rotation YY. According to one embodiment, the second tip link 20 comprises an axial recess 45 forming a housing seat for the opposing blade link 40. The axial recess 45 is preferably defined in the axial direction by an axially inwardly facing surface 48 of the second tip link 20.
[0177] According to a preferred embodiment, the opposed blade link 40 is elastically deformable by bending, such that when the cutting edge 34 of the blade link 30 mechanically interferes with the opposed blade surface 24 of the opposed blade link 40 to perform a cutting action, the body of the opposed blade link 40 also elastically bends in the axial direction.
[0178] The opposed blade link 40 is preferably made from an elastic sheet or strip and is pre-curved to form a curved, protruding opposed blade surface 24 with an axially inwardly facing concave surface for elastically bending the blade link 30 during the cutting operation. Providing an opposed blade link 40 with a curved, protruding opposed blade surface 24 that is elastically deformable by bending makes it possible to obtain an elastic reaction force between the axially inwardly facing surface 48 of the axial recess 45 of the second tip link 20 and the cutting edge 34 of the blade link 30 during the cutting operation. In particular, the opposed blade link 40 comprises an axially oriented stationary surface 46 opposite the opposed blade surface 24 that abuts against said axially inwardly facing surface 48 of the axial recess 45 of the second tip link 20, enabling the opposed blade link 40 to provide an elastic movement to the cutting edge 34 of the blade link 30 for elastically bending the blade link 30 during the cutting operation.
[0179] The opposing blade link 40 may have at least some, but also all, of the features and characteristics described above with reference to the blade link 30. The thickness of the opposing blade link 40 may be substantially equal or equal to the thickness of the blade link 30, as described above. According to one embodiment, the opposing blade link 40 preferably comprises an opposing blade cutting edge 44 arranged opposite to the cutting edge 34 of the blade link 30, i.e. in other words, the cutting edge 44 of the opposing blade faces the gripping side P2 of the second tip link 20. The fourth proximal attachment root 41 of the opposing blade link 40 may have at least some, but also all, of the features and characteristics described above with reference to the third root 31 of the blade link 30. In particular, according to a preferred embodiment, said fourth root 41 of the opposing blade link 40 defines a fourth through hole 46 for receiving said articulation pin 5. The fourth root 41 may comprise a radial cut channel 49 misaligned with the radial cut channel 39 of the blade link 30.
[0180] According to one embodiment, a reaction force engagement is provided along or distal to the longitudinal extension of the opposing blade surface 24 to allow the opposing blade link 40 and the second tip link 20 to rotate together. Preferably, the reaction force engagement is obtained near or at the distal end 42 of the opposing blade link 24.
[0181] According to one embodiment, the second tip link 20 comprises a reaction seat 47 having an open reaction surface 27.2 and an opposite closed reaction surface 27.1 for rotating the blade holder link 40 together. The reaction seat 47 may be located distally in a reaction seat formed as an undercut relative to the second gripping surface 23 of the second tip link 20 for receiving a distal end 42 of the opposing blade link 40. According to one embodiment, said distal end 42 of the opposing blade link comprises an open reaction surface 47.2 in reaction contact with said open reaction surface 27.2 of the second tip link 20 and an opposite closed reaction surface 47.1 in reaction contact with said closed reaction surface 27.1.
[0182] For example, according to the embodiment shown in FIG. 29B , the opposing blade link 40 comprises a radial drag ear 47.0 folded onto the second root portion 21 of the second tip link 20, said drag ear 47.0 of the opposing blade link 40 comprising an open drag surface 47.2 in drag contact with an open drag surface 27.2, for example, arranged on the back side D2 of the connection portion 82 of the body of the second tip link 20, and the opposing blade link 40 further comprises a closed drag surface 47.1 arranged adjacent to the distal end 42 of the opposing blade link 40 in drag contact with the closed drag surface 27.1 of the second tip link 20.
[0183] According to the embodiment shown in FIG. 27, for example, the opposing blade cutting edge 44 can have a concave shape relative to the opening / closing direction.
[0184] According to a general embodiment, a revolute joint 502 of an articulation according to any one of the previous embodiments is provided.
[0185] The rotary joint 502 of the disconnect joint is an axially rigid coupling.
[0186] According to a general embodiment, there is provided a robotic surgery system 101 comprising at least one needle holder / cutter type surgical instrument 1 according to any one of the previously described embodiments. The robotic surgery system 101 is thus capable of performing anastomosis and / or suturing surgical or microsurgical procedures in which the needle holder / cutter type surgical instrument 1 can manipulate a surgical needle and simultaneously cut a suture wire.
[0187] According to one embodiment, the robotic surgical system 101 comprises two surgical instruments, at least one of which is a needle holder / cutter type surgical instrument 1 according to any one of the previous embodiments, and the other surgical instrument may be a needle driver type surgical instrument or a dilator type surgical instrument, but according to one embodiment, both surgical instruments are needle holder / cutter type surgical instruments 1.
[0188] The robotic surgery system 101 preferably comprises at least one robotic manipulator 63, to which at least one surgical instrument 1 of needle holder / cutter type is operatively connected. For example, a sterile surgical barrier (not shown), such as for example a sterile surgical drape, is interposed between the at least one robotic manipulator 63 and the rear end portion 61 of the at least one surgical instrument 1 of needle holder / cutter type. The robotic manipulator 63 stresses the actuation tendons of the pitch P, yaw Y and gripping degrees of freedom G. That is, it can comprise an electric actuator for gripping and cutting the surgical instrument 1 and for rotating the surgical instrument 1 around a shaft 7 that defines a rolling degree of freedom. The robotic surgery system 101 can comprise a support 69 (cart or tower), for example with wheels or other ground-mounted units, and an articulated positioning arm 70, for example manually movable, i.e. passive, extending between the support 69 and the at least one robotic manipulator 63. According to one embodiment, the robotic surgery system 101 comprises at least one master console 68 for controlling at least one surgical instrument 1 of needle holder / cutter type, preferably also a respective robotic manipulator 62, according to a master-slave configuration, preferably the robotic surgery system 101 further comprises a control unit operatively connected to the master console 68 and to the robotic manipulator 63 so as to determine the tracking of the needle holder / cutter type surgical instrument relative to the at least one master control device 50 of the master console 68. According to one embodiment, the master console 68 comprises at least one master control device 50 that is untethered, i.e. mechanically decoupled from the ground, and a tracking system, e.g. optical and / or magnetic.
[0189] Thanks to the above features, provided separately or in combination with one another in certain embodiments and certain operating modes, the aforementioned needs can be met, even in discrepancies, and the aforementioned advantages can include, in particular, the following advantages:
[0190] The opening and closing degrees of freedom make it possible to perform a gripping action of a surgical needle in a part of the end effector at the gripping surfaces of the first and second distal links and a cutting action of a suture wire in a proximal part relative to the gripping surfaces of the first and second distal links.
[0191] Extreme miniaturization of the articulated end effector of the needle holder / cutter type surgical instrument is possible relative to known solutions.
[0192] It is possible to stack the roots of the links between the protrusions of the support structure while avoiding the provision of elastic washers and adjustment screws as well as tapping or thread machining at the level of the mounting roots, thus allowing extreme miniaturization of the articulated end effector.
[0193] In particular, the articulating pin 5 is not threaded.
[0194] The edge surfaces of the through holes at the root of each link are not tapped, i.e., not threaded, and the inner surfaces of the through holes of the projections that pass through the projections of the support structure are not tapped, i.e., not threaded.
[0195] - Absence of elements such as Belleville washers attached to the articulating pins.
[0196] On the other hand, all the elasticity required for the cutting action is concentrated on the outside of the root, i.e. in the body of the blade link 30 (and the opposing blade link, if present), making it possible to create a very compact articulated end effector while still performing a precise cutting action.
[0197] In particular, at relatively high degrees of freedom for opening and closing the blade, the blade is free, i.e. not elastically stressed, and preferably in such a configuration the blade is straight. In the open configuration of the open and closed degrees of freedom, the blade can overlap the rotational footprint of the projecting opposing blade, i.e. the rotational footprint of the second tip link (as well as the opposing blade link, if present), and in the open configuration of the open and closed degrees of freedom, the blade is spaced apart relative to the connection of the first tip link, in particular from the axially inward surface 18 of the first tip link, thereby defining a deformation seat 14 for the blade.
[0198] As the opening angle of the opening / closing degree of freedom closes, the blade is elastically bent and elastically pushes against the opposing blade 24. In the closed configuration of the opening / closing degree of freedom, the blade can be brought into contact between the connection of the first and second tip links to interpose the blade between the connection of the first and second tip links (or contact the opposing blade link, if present, and then interpose the blade between the blade and the body of the second tip link).
[0199] The elasticity required for the cutting action is concentrated distally of the blade link body relative to the root, making it possible to provide a deformation seat that can undergo a relatively high axial bending of the blade.
[0200] - the roots stacked in a pack between the projections provide a reaction force against the elastic bending deformation of the blade, avoiding axial sliding on the pin and thus enabling a precise and effective cutting action of the cutting edge 34 even at high opening angles, i.e. the cutting edge can press the opposing blade even proximally at the location of the root adjacent to the articular pin.
[0201] -While the first and second tip links are directly actuated by the actuating tendons, the blade link and opposing blade link, if present, are rotationally resisted by the first and second tip links.
[0202] The provision of such a third root portion 31 of the blade link 30 allows the blade link 30 to be rigidly fixed to the common axis of rotation YY when in operation, for example during a cutting operation, and the provision of such a reaction seat 17 for the integral rotation of the first tip link 10 and the blade link 30, arranged close to the distal end 32 of the blade link, allows the blade link 30 to be rigidly fixed while undergoing axial deformations of the distal end 32 of the blade link (the same applies to the opposing blade link 40, if present), providing a robust and reliable solution that allows for an extremely compact articulated end effector without inaccuracies in positioning and cutting, while avoiding the risk of loss of the blade link, i.e. detachment of the blade link when in operation.
[0203] - by providing through-holes in all coaxial roots which receive in contact the articulating pins, unintentional relative rotation between the roots can be avoided and provides certainty of positioning of the cutting edge 34 of the blade link 30 relative to the opposing blade surface 24 and the gripping surfaces 13, 23 when in operation, thus allowing extreme miniaturization of the articulated end effector, since small rotational movements at the level of the roots, i.e. next to the common axis of rotation, would result in relatively large cutting imprecisions.
[0204] Furthermore, the hole 36 in the blade link has its proximal edge pressing against the pin, thereby providing a counter force against the friction between the blade and the opposing blade during the cutting action, helping to obtain a precise cutting action.
[0205] The cutting edge of the blade link can be straight, i.e. without concavity, facilitating serial production, for example starting from a single band or strip.
[0206] - When present, the integral rotation of the blade link with the free end and the opposing blade link makes it possible to carry out the cutting action in various orientations of the yaw degree of freedom, so as to reproduce the orientation of the surgeon's hand, and therefore has a great intuitiveness and is also easy to observe, for example, under a microscope.
[0207] By providing abutment of the closure stroke end away from and distal to the articulation pin, high precision closure is possible while not occupying the proximal area of the support fork, facilitating extreme compactness.
[0208] The integrally made tendon with each link and end seat of the woven pulley surface is advantageous for compactness, keeping the number of parts low and helping to keep the articulated end effector compact.
[0209] - In the case of needle driver / scissor type surgical instruments, the blade can be interposed between the tip links, allowing the blade to be hidden by the closed end effector, e.g., wrapping a suture wire around the tip links without damaging the suture wire.
[0210] The provision of a single drag engagement in rotation between the two links allows drag clearance to be minimized, facilitating compactness.
[0211] The revolute joint 502, which defines the common rotation axis YY, may be a hinge.
[0212] It will be fully understood that any combination of features, structures, or functions disclosed in one or more of the appended claims forms an integral part of this specification.
[0213] To meet certain contingent needs, those skilled in the art can make some modifications and adaptations to the above-described embodiments and replace elements with other elements that are functionally equivalent, without departing from the scope of the appended claims. [Explanation of symbols]
[0214] 1 Needle holder / cutter type surgical instrument 2 Support Links 3 First support structure protrusion 4 Second support structure protrusion 5 Pivot pin or articulated pin 6 Suture or suture wire 7 Surgical Instrument Shafts 8 Distal Shaft End 9 Articulated end effector or articulated terminal 10 First tip link or blade holder link 11: a first proximal attachment root portion of a first distal link, or an attachment root portion of a first distal link 12 a first distal free end of the first tip link, or a free end of the first tip link 13 First gripping surface of the first end link, or gripping surface of the first end link 14 Deformed seat for first tip link blade 15 First end seat of first link, or end seat of first link 16: A first through hole in a first root portion of a first end link, or a root portion hole in a first end link 16.1 Hole edge of first hole of first root part 17 Reaction seat of first end link 17.0 Drag tooth on first tip link 17.1 Closing reaction surface of the first end link 17.2 First end link opening resistance surface 18 First end link surface facing axially inward 19 Cut channel in first root portion of first end link 20 Second tip link or reaction link 21 second proximal attachment root portion of second distal link, or attachment root portion of second distal link 22 a second distal free end of the second tip link, or a free end of the second tip link 23 Second gripping surface of second end link, or gripping surface of second end link 24 Opposing Blade Surface 25 Second end seat of second link or second link end seat 26 A second through hole in a second root portion of the second end link, or a root portion hole in the second end link 26.1 Hole edge of second hole in second root section 28 Screw-fixed wall 28.1 Screw-mounted wall recess 29 Cut channel in second root portion of second tip link 30 Blade link or blade 31 third proximal attachment root of blade link or blade link root 32 Tip blade link end 33 Horizontal Blade Link Bridge 34 Blade link cutting edge 35 Blade surface facing axially inward of the blade link 36 Third through hole in the third root portion of the blade link, or a root hole in the blade link 36.1 Edge of the third hole at the third root 37 Drag ear of third blade link 37.1 Closing drag opposing surface of blade link 37.2 Blade link opening drag opposing surface 38 Arc surface of hole edge of third root part of blade link 39 Blade link third root cut channel 40 Opposed Blade Link 41 the fourth proximal attachment root of the opposing blade link, or the fourth root of the opposing blade link 42 distal opposing blade link end 43 through hole of opposing blade link or fourth hole of fourth root portion of opposing blade link 43.1 Edge of through hole at root of opposing blade link 44 Opposing Blade Cutting Edge 45 Axial recess of opposing blade link 46 Opposing blade link support surface 47 Reaction seat of second end link 47.0 Drag ears on opposed blade links 47.1 Closure drag opposing surfaces of opposing blade links 47.2 Opposed blade link opening drag opposing surface 48 Second end link surface facing axially inward 49 Cut channel for opposing blade links 50 Master Control Device 51: a first inner contact surface of a first root portion of a first end link, or an inner contact surface of a root portion of a first end link 52 A first external contact surface of a first root portion of a first end link, or an external contact surface of a root portion of a first end link 53 A first inner contact surface of a first projection of a support link, or an inner contact surface of a first projection of a support link 54 A second inner contact surface of the second projection of the support link, or an inner contact surface of the second projection of the support link 55 A second outer contact surface of a second root portion of a second end link, or an outer contact surface of a root portion of a second end link 56 A second inner contact surface of a second root portion of a second end link, or an inner contact surface of a root portion of a second end link 57 The contact surface of the third root portion of the blade link facing the opposing blade, or the second contact surface of the third root portion of the blade link 58 first contact surface of third root portion of blade link 59 Contact surface of fourth root of opposing blade link 60 End effector link or connecting link for connecting to shaft 60.1 First protrusion of connecting link 60.2 Second protrusion of connecting link 61 Rear end portion or proximal interface portion of surgical instrument 62 Proximal Shaft End 63 Robot Manipulator 64 Shaft fixing device 66 The contact surface of the fourth root of the opposing blade link facing the blade 67 Third end seat of support link 68 Master Console 69 Support, cart, or tower of robotic system 70 Articulated Positioning Arm for Robot System 71 First end link release tendon 72 First end link closing tendon 73 Release action tendon of the second end link 74 2nd end link closing tendon 75 Operating tendon of supporting link 76 Support Link Operation Opposite Tendon 77 Cantilever drag leg of first end seat of first end link 78 Cantilever drag leg of second end seat of second tip link 79 Woven pulley surface of first end link 80 Woven pulley surface of second end link 81 a first tip link connection between the first root portion and the first gripping surface 82 a second tip link connection between the first root portion and the first gripping surface 70 Tendon End 84 Convex ruled surface of support link 85 Convex ruled surface of connecting link 86 Opposite convex ruled surfaces of support links 87 Opposing convex weave sliding surfaces of connecting links 101 Robotic Surgery System 165 Projection hole 502 Rotation joint of cutting joint or distal rotation joint 509 Proximal Rotation Joint XX Longitudinal shaft axis YY common rotation axis, or common distal rotation axis, or common yaw rotation axis PP Common proximal rotation axis or common pitch rotation axis Y Yaw Degree of Freedom P pitch freedom G Open / close direction, gripping degree of freedom R Roll Degree of Freedom POC At least one point of contact between a blade and an opposing blade D1 Back side of first end link P1 Gripping side of the first tip link D2 Back side of second tip link P2 Gripping side of second tip link
Claims
1. A needle holder / cutter type surgical instrument (1) for a robotic surgery system (101) comprising an articulated end effector (9), wherein the articulated end effector (9) comprises a support structure including two protrusions (3, 4), a first proximal attachment root portion (11), a first distal free end (12), and a first tip link (10) having an elongated body integrally provided with a first gripping surface (13) between the first proximal attachment root portion (11) and the first distal free end (12), a second proximal attachment root portion (21), a second distal free end (22), and a second tip link (20) having an elongated body integrally provided with a second gripping surface (23) between the second proximal attachment root portion (21) and the second distal free end (22), a third proximal attachment root portion (31), an elastically deformable bending body, and a blade link (30) integrally provided with a cutting edge (34), and comprising the support structure, the first tip link (10), the second tip link (20), and the blade link (30) are separate components that are articulately coupled to each other about a common rotation axis (Y - Y), defining an axial direction that coincides with or is parallel to the common rotation axis (Y - Y), the blade link (30) rotates integrally with the first tip link (10), the first proximal attachment root portion (11) of the first tip link (10), the second proximal attachment root portion (21) of the second tip link (20), and the third proximal attachment root portion (31) of the blade link (30) are adjacent to each other in the axial direction, the first proximal attachment root portion (11) of the first tip link (10), the second proximal attachment root portion (21) of the second tip link (20), and the third proximal attachment root portion (31) of the blade link (30) are articulately coupled to the protrusions (3, 4) of the support structure about the common rotation axis (Y - Y), defining a degree of freedom in direction (Y) between the support structure and the group formed by the first tip link (10), the second tip link (20), and the blade link (30), The first proximal attachment root portion (11) of the first distal link (10) and the second proximal attachment root portion (21) of the second distal link (20) are articulately coupled to each other around the common rotation axis (Y-Y), defining a relative opening / closing degree of freedom (G) between the second distal link (20) and a group formed by the first distal link (10) and the blade link (30). A facing blade surface (24) that rotates integrally with the second distal link (20) is provided. The facing blade surface (24) abuts against the cutting edge (34) of the blade link (30) and is adapted to elastically bend the blade link (30) in the axial direction, whereby the cutting edge (34) of the blade link (30) and the facing blade surface (24) reach a mechanically interfering contact state to perform a cutting operation. Needle holder / cutter type surgical instrument (1). [
2. ] The group formed by the first proximal attachment root portion (11) of the first distal link (10), the second proximal attachment root portion (21) of the second distal link (20), and the third proximal attachment root portion (31) of the blade link (30) is jointly inserted and sandwiched between the two protrusions (3, 4) of the support structure and is in direct close contact with them. The needle holder / cutter type surgical instrument (1) according to claim 1. [
3. ] The third proximal attachment root portion (31) of the blade link (30) is axially inserted and sandwiched between the first proximal attachment root portion (11) of the first distal link (10) and the second proximal attachment root portion (21) of the second distal link (20) and is in direct close contact with them. The needle holder / cutter type surgical instrument (1) according to claim 1 or 2. [
4. ] The first proximal attachment root portion (11), the second proximal attachment root portion (21), the third proximal attachment root portion (31), and the protrusions (3, 4) are all parallel to each other and include contact surfaces (51, 52, 53, 54, 55, 56, 57, 58) facing axially respectively. The needle holder / cutter type surgical instrument (1) according to claim 1. [
5. ] The first proximal attachment root portion (11) of the first tip link (10) includes a first through hole (16), the second proximal attachment root portion (21) of the second tip link (20) includes a second through hole (26), and the third proximal attachment root portion (31) of the blade link (30) includes a third through hole (36). The first through hole (16) of the first proximal attachment root portion, the second through hole (26) of the second proximal attachment root portion, and the third through hole (36) of the third proximal attachment root portion are all circular through holes, coaxial with the common rotation axis (Y-Y), and receive one articulation pin (5) that axially extends from the first protrusion (3) to the second protrusion (4) of the support structure. The needle holder / cutter type surgical instrument (1) according to claim 1.
6. The third through hole (36) of the third proximal attachment root portion (31) of the blade link (30) has a hole edge portion, and the hole edge portion is in direct close contact with the articulation pin (5) throughout the extension of the hole edge portion. The needle holder / cutter type surgical instrument (1) according to claim 5.
7. The opposing blade surface (24) that rotates integrally with the second tip link (20) protrudes axially to bend the blade link (30). Preferably, the opposing blade surface (24) is a curved protruding surface having a concave surface facing axially inward. The needle holder / cutter type surgical instrument (1) according to claim 1.
8. The body of the blade link (30) is substantially planar in the non-deformed state and lies on a definable deflectable surface. Preferably, the blade surface (35) of the blade link (30) facing axially is parallel and aligned with the contact surface (57) of the third proximal attachment root portion (31) of the blade link (30) that is in direct close contact with the second proximal attachment root portion (21) of the second tip link (20). The needle holder / cutter type surgical instrument (1) according to claim 1.
9. The cutting edge (34) of the blade link (30) is inserted and sandwiched between the first connection portion (81) of the body of the first tip link (10) and the second connection portion (82) of the body of the second tip link (20), and is adjacent to these. The first connecting portion (81) extends between the first proximal attachment root portion (11) and the first gripping surface (13), and the second connecting portion (82) is between the second proximal attachment root portion and the second gripping surface (23). The needle holder / cutter type surgical instrument (1) according to claim 1.
10. The first tip link (10) includes an axially extending axial deformation seat portion (14) for receiving the elastic bending of the blade of the blade link (30) during the cutting operation. Preferably, the axial deformation seat portion (14) is Preferably parallel to the opposing blade surface (24) and axially defined by the axially inward surface (18) of the first tip link (10). The needle holder / cutter type surgical instrument (1) according to claim 1.
11. In order to rotate the blade link (30) integrally with the first tip link (10), a resistance engagement portion is provided along the longitudinal extension of the cutting edge (34) of the blade link (30) or disposed distally with respect to the cutting edge of the blade link (30). Preferably, the resistance engagement portion is adjacent to the cutting edge (34) of the blade link (30) or provided at the distal end of the cutting edge (34). The needle holder / cutter type surgical instrument (1) according to claim 1.
12. The second tip link (20) includes a threaded wall (28). The threaded wall (28) is preferably Facing the gripping side (P2) of the body of the second tip link (20), defining a recess (28.1) for receiving the suture wire (6), and maintaining contact between the suture wire (6) and the cutting edge (34) of the blade of the blade link (30) during cut closure. The needle holder / cutter type surgical instrument (1) according to claim 1.
13. The articulated end effector (9) is Three parts, namely, the first tip link (10), the second tip link (20), and the blade link (30), and the three parts are articulately coupled about the common rotation axis (Y - Y) to the support structure including the two protrusions (3, 4), the three parts, Furthermore, a further part which is a joint pin (5) defining the common rotation axis (Y - Y). Is exactly configured by Or The articulated end effector (9) is Four parts articulated to the common axis of rotation (Y-Y), namely, a support link (2), the first tip link (10), the second tip link (20), and the blade link (30), wherein the support link (2) includes the protrusions (3, 4), and the four parts; Further, a further part which is an articulation pin (5) defining the common axis of rotation (Y-Y); In addition, a further part which is a proximal articulation pin defining the proximal axis of rotation (P-P) of the support link (2); Is exactly configured; The needle holder / cutter type surgical instrument (1) according to claim 1.
14. The first proximal attachment root portion (11) of the first tip link (10) integrally includes at least a first terminal seat portion (15) for at least one operating tendon (71, 72) of the first tip link (10) around the common axis of rotation (Y-Y); The second proximal attachment root portion (21) of the second tip link (20) integrally includes at least a second terminal seat portion (25) for at least one operating tendon (73, 74) of the second tip link (20) around the common axis of rotation (Y-Y); Preferably, the support structure including the two protrusions (3, 4) is included in the support link (2) articulated to the distal end (8) of the shaft (7) around the proximal axis of rotation (P-P), and integrally includes at least a third terminal seat portion (67) for at least one operating tendon (75, 76) of the support link (2) around the proximal axis of rotation (P-P); The needle holder / cutter type surgical instrument (1) according to claim 1.
15. A robotic surgical system (101) comprising at least one of the needle holder / cutter type surgical instruments (1) according to claim 1.