Surgical instruments for robotic surgery
The articulated end effector design with separate components and reduced friction tendons addresses the challenges of miniaturization and assembly complexity in robotic microsurgery, ensuring precise and reliable cutting in needle holder/cutter instruments.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- MEDICAL MICROINSTRUMENTS INC
- Filing Date
- 2022-06-16
- Publication Date
- 2026-06-17
Smart Images

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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 type surgical instrument according to the present invention is particularly suitable for application in robotically remote-controlled microscopic surgery.
[0003] The present invention further relates to a robotic surgical system comprising at least one needle holder / cutter type surgical instrument.
Background Art
[0004] Robotic surgical devices are generally known in the art and typically comprise a central robotic tower (or cart) and one or more robotic arms extending from the central robotic tower. Each arm comprises an electric positioning system (or manipulator) for moving a distally attachable surgical instrument for performing surgical procedures on a patient. The patient generally lies on an operating table disposed in an operating room, which is rendered aseptic to avoid bacterial contamination by non-sterile parts of the robotic device.
[0005] Conventionally, i.e., in surgeries that do not use robots, needle holder / cutter type instruments are generally known. This type of instrument typically comprises a needle holder / cutter formed by two free ends having a gripping surface for a surgical needle and a blade for cutting sutures at opposite ends of an operating ring. In some cases, the blade is made in a seat or recess formed within the gripper body and is accessible via a separate access opening different from the opening for accessing the gripping surface of the needle.
[0006] Furthermore, in the field of robotic surgery, a needle holder / cutter type end effector solution for laparoscopy has been proposed to be disposed at the distal end of an elongated shaft.
[0007] For example, as described in U.S. Patent Application Publication No. 2019-298465, the blade is generally co-formed with each gripping surface for the needle, and the needle forms a cantilever projection with respect to the gripping surface and is positioned proximal to the gripping surface, i.e., between the gripping surface and the articulated hinge of the gripping surface. Thus, a single molded part typically comprises a root portion for forming part of the hinge, a free end, a gripping surface, and a blade extending relative to the gripping surface in the closing direction toward the other opposing blade on the opposite side of the end effector.
[0008] In the hinge, a single 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, determining the mechanical interference state between the blades for the purpose of cutting when closed. Therefore, when the end effector closes, the two opposing blades come into contact at a certain point, causing lateral slippage between their respective roots and canceling out the elastic influence on the hinge exerted by the elastic Belleville washers.
[0009] In addition, U.S. Patent Application Publication No. 2019-0105032 describes a cutting end effector in which each blade integrally comprises an elastic cantilever tab, the two elastic cantilever tabs extending toward each other in a direction parallel to the pin, thereby providing an elastic preload through contact between the two cantilever tabs. This avoids the need to assemble a Belleville-type elastic washer on the hinge, thus leaving an axial space in the hinge between the two blades that can adapt to sliding due to variations in the elastic reaction force exerted by the mutually contacting cantilever elastic tabs.
[0010] In addition to or in place of multiple "Belleville washer" type washers, an adjustment screw, usually forming the joint pin itself, can be provided in the hinge to adjust cutting interference between blades. When the adjustment screw is provided in combination with multiple "Belleville washer" type elastic washers, the adjustment screw acts by counteracting the elastic action of the spring, enabling the adjustment of the elastic preload.
[0011] Typically, known solutions suggest incorporating further functions, such as electrocautery capabilities, into the same end effector by providing electrodes positioned on the gripping surface. For example, the blade of a needle holder / cutter type instrument can be made from a single piece co-molded with each free end and gripping surface of the end effector, and the gripping surface itself can be equipped with electrical connections that constitute the electrocautery electrodes.
[0012] Another known example is given in U.S. Patent Application Publication No. 2020-0107894, which describes a solution for a needle holder / cutter in which the blade is housed in a longitudinal pocket of a gripping link and is rotatable independently of the pocket, thereby allowing the blade to be removed as needed.
[0013] Miniaturization of the ends or end effectors of surgical instruments, particularly those used in robotic surgery, is especially desirable because it opens up advantageous scenarios that minimize invasiveness for the patient undergoing surgery and provide millimeter and sub-millimeter cutting capabilities for tissue.
[0014] The aforementioned known solutions are unsuitable for further miniaturization because they impose impossible processes for manufacturing the parts, as well as complex assembly strategies for obtaining the assembled end effector. For example, consider the need to assemble micro-components into the hinge while counteracting the elastic reaction force of a Belleville-type elastic washer, and the objectively extreme difficulty of manufacturing by co-forming micro-ridges and micro-undercuts that must be robust enough to withstand fairly high stresses during operation, while simultaneously being geometrically shaped to minimize friction. Indeed, as is well known, at the microscale, surface forces such as friction are dominant over volume forces.
[0015] In addition to the difficulties in micro-machining of micro-ridges, micro-grooves, and undercuts, the elastic cantilever tabs obtained within the blade body, as mentioned above in relation to known solutions, are also extremely difficult to cut and shape in a precise and reproducible manner at the micro-scale.
[0016] Furthermore, as the scale decreases, precisely sizing elements intended to be formed when rotary joints, such as end-effector gripping terminals of surgical instruments, are assembled becomes increasingly complex. This is because small machining uncertainties at the fulcrum level result in significant inaccuracies near each cantilever free end positioned distal to the rotary joint. Rotary joints typically handle extremely delicate micromanipulation of surgical needles, suture wires, and anatomical parts of the patient undergoing surgery.
[0017] When attempting to transmit a high closing force that enables precise cutting without damaging the actuating tendon, providing leverages associated with the blade (a solution known in the art) also becomes an obstacle to miniaturization. In addition to the sole objective difficulty of manufacturing the parts at very small scales while simultaneously proving robustness under operating conditions, there are also the footprint in the area close to the common axis of rotation of the free end, and the difficulty of assembly.
[0018] The end effectors, namely the cutting blade and gripping surface, located distal to the hinge, are generally designed to perform extremely precise work, while the cutting blade must ensure accurate and clean cutting action.
[0019] The same applicant's U.S. Patent No. 10864051, International Publication No. 2017-064301, International Publication No. 2019-220407, International Publication No. 2019-220408, International Publication No. 2019-220409, and U.S. Patent Application Publication No. 2021-059776 disclose remote surgical robotic surgical systems having one or more surgical instruments controlled by one or more master interfaces. Furthermore, U.S. Patent No. 10582975, European Patent No. 3586780, International Publication No. 2017-064303, International Publication No. 2018-189721, International Publication No. 2018-189729, U.S. Patent Publication No. 2020-0170727, and U.S. Patent Publication No. 2020-0170726 by 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 section having an interface to be driven by a robotic manipulator, a shaft, and an articulated cuff at the distal end of the shaft. The articulated cuff consists of multiple links moved by multiple tendons (or actuation cables). The two end links have free ends and degrees of freedom of opening and closing between them, and can be adapted to manipulate needles and suture wires, forming a needle holder gripper-type end effector for remote surgical robotic surgery to perform anastomoses or other surgical treatments.
[0020] For example, the same applicant's International Publication No. 2017-064306 describes a surgical instrument in which a tendon for actinguating the opening and closing degrees of freedom of an articulated end effector link slides on the convex wire-woven sliding surface of the end effector link, while simultaneously avoiding routing the tendon within a guide groove or channel having a recess. This minimizes the cross-section of the sliding contact portion between the tendon and the link, thus reducing sliding friction and promoting miniaturization of the articulated end effector while ensuring the high dexterity provided by the end effector joint, such as a pitch and yaw rotary joint.
[0021] Furthermore, the same applicant's International Publication No. 2018-189722 discloses a surgical instrument in which a tendon for actinguating the opening / closing degrees of freedom of an articulated end effector is wound over the convex woven sliding surface of the end effector link, in addition to sliding over the said convex woven sliding surface, as discussed previously, and exhibits an arc-shaped path that forms the basis for particularly large winding angles. In fact, due to the low sliding friction of the tendon, the tendon may remain in contact with the convex woven surface of the link over a relatively long, arc-shaped longitudinal cross-section.
[0022] Furthermore, U.S. Patent Application Publication No. 2021-0106393 of the same applicant discloses several embodiments of tendons made of intertwined polymer fibers. The use of polymer tendons allows for reduced sliding friction compared to the use of metal tendons, while the proper sizing of the tendons allows for movement along winding longitudinal paths in articulated end effectors. [Overview of the project] [Problems that the invention aims to solve]
[0023] Therefore, there is a strong need to provide a solution for needle holder / cutter-type surgical instruments that are suitable for extreme miniaturization, while simultaneously being robust, reliable, and capable of providing accurate and repeatable cutting action.
[0024] Furthermore, there is a need to propose a solution for a needle holder / cutter type surgical instrument for remote surgery robots for microsurgery that is easy to assemble, easy to construct, reliable under operating conditions, accurate and robust. This needle holder / cutter type surgical instrument is adapted, for example, with respect to the main longitudinal extension of the surgical instrument body, to enable a desired controlled spatial direction of the cutting operation, thereby facilitating the observation of the surgery.
[0025] There is a need to propose a solution that enables the assembly of an articulated tip microinstrument equipped with a grip and scissors, is composed of a minimum number of components without reducing the dexterity of the articulated end effector, and can be assembled easily and cost-effectively in a way that is not burdensome.
[0026] There is a need to propose a solution that enables the manufacture of micromechanical parts, especially sharp micromechanical parts, with high geometric accuracy and reproducibility for the formation of an articulated tip microinstrument equipped with a grip and scissors.
[0027] The object of the present invention is to eliminate the drawbacks described with respect to the background art.
Means for Solving the Problems
[0028] This object and other objects are achieved by the needle holder / cutter type 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 present invention, a needle holder / cutter type surgical instrument for a robotic surgical system comprises an articulated end effector, the articulated end effector comprising a support structure including two projections, a first end link having an elongated body integrally comprising a first proximal attachment base, a first distal free end, and a first gripping surface between them, and a second end link having an elongated body integrally comprising a second proximal attachment base, a second distal free end, and a second gripping surface between them.
[0031] The articulated end effector further comprises a blade link that integrally includes a third proximal mounting base, an elastically deformable bending body, and a cutting edge.
[0032] The blade link rotates integrally with the first tip link, which acts as a blade holder link. A resistance engagement portion, which may be positioned distal to the cutting edge, can be provided between the blade link and the first tip link.
[0033] Furthermore, an opposing blade surface is provided that rotates integrally with the second tip link and therefore acts as a reaction link. A further opposing blade link having an opposing blade link root can be provided.
[0034] The opposing blade surface is fitted to contact the cutting edge of the blade link and elastically bend the blade link in the axial direction, thereby bringing the cutting edge of the blade link and the opposing blade surface into mechanical contact and performing a cutting operation.
[0035] Opposing blades can be sharp and have cutting edges.
[0036] The support structure, the first end link, the second end link, and the blade link are separate components that articulate with each other on a common axis of rotation, defining an axial direction that coincides with or is parallel to the common axis of rotation.
[0037] The root portions are adjacent to each other in the axial direction and articulated with projections of the support structure, defining the rotational joint of the cutting joint. The rotational joint may be an axial rigid rotational joint, in which case no elastic element is provided at the joint, and elasticity is provided distal to the rotational joint, i.e., in the blade of the blade link.
[0038] The support structure can be comprised of a support link made from a single component.
[0039] The support structure can be formed integrally with the distal end of the rod or shaft of the surgical instrument.
[0040] According to one embodiment, the root portion is interposed as a whole in the pack between the two projections of the support structure, making direct contact with them and providing a reaction force against the elastic bending of the blade of the blade link during the cutting operation, and there is no preload elastic element in the axial direction, nor is there an adjustment screw. The first, second and third root portions and the projections of the support structure may each have two contact surfaces that are in contact with each other, and these contact surfaces face in the axial direction and are all parallel to each other.
[0041] According to one embodiment, the third root of the blade link is axially interposed between the first root of the first tip link and the second root of the second tip link, in close contact with them, and provides a reaction force against the elastic bending of the blade of the blade link during the cutting operation. The determinable axial distance between the projections may remain constant under any cutting conditions. The first mounting root may have a first surface facing axially outward, and the second root may have a second surface facing axially outward, and it can be confirmed that the further axial distance between the first surface and the second surface remains constant under any cutting conditions.
[0042] According to one embodiment, each base portion is provided with a through hole, and all through holes are located on the axis to receive the joint pin.
[0043] The opposing blade surface, which rotates integrally with the second tip link, can be made to protrude axially to bend the blade link during movement of the opening and closing degrees of freedom.
[0044] According to one embodiment, the opposing blade surface is a curved protruding surface having a concave surface facing axially inward.
[0045] According to one embodiment, the blade link body is substantially planar in its non-deformable form and lies on a defined reclining surface, preferably the blade surface facing the axial direction of the blade link is parallel and aligned with the contact surface of the third root of the blade link, which is in direct close contact with the second root of the second tip link.
[0046] The first tip link, together with a portion thereof, can define an axially deformable seat that extends axially to receive the elastic bending of the blade of the blade link during the cutting operation. In one embodiment, the axially deformable seat is preferably axially defined (delimited) by the surface of the first tip link facing axially inward and parallel to the opposing blade surface.
[0047] According to one embodiment, the second tip is provided with a screw-fastened recess for receiving a suture wire in order to keep the suture wire in contact with the cutting edge of the blade of the blade link during cutting and closure.
[0048] According to one embodiment, the first root portion of the first tip link integrally includes at least a first end seat portion for at least one actuating tendon of the first tip link centered on the common rotation axis, and the second root portion of the second tip link integrally includes at least a second end seat portion for at least one actuating tendon of the second tip link centered on the common rotation axis.
[0049] The support structure including the two projections may be included in a support link articulated with respect to the distal end of the shaft around a proximal rotation axis, and integrally comprising 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 integrally include one or more convex wire-woven sliding surfaces for the actuation tendons of the first and second end links.
[0051] Preferably, the definable axial distance between the surface of one or more convex wire-woven sliding surfaces of the support link and the end seat between the end seat portions of the first or second root portion remains constant in any cutting state, preferably even in a gripping state.
[0052] According to one embodiment, the blade provides the axial elasticity necessary to perform the cutting operation, and the base is axially compressed by a support structure, thereby reacting to the elastic bending of the blade and preventing axial displacement between the bases.
[0053] The body of the second tip's opposing blade can be elastically bent axially, preferably axially outward. Thus, the axial elasticity required to perform the cutting action is provided by the blade and the opposing blade together or separately, for example, depending on the tip's opening angle.
[0054] According to one embodiment, a first pair of opposing tendons is connected to a first mounting base, for example, the base of a blade holder link, to move the cutting edge around the common distal rotation axis, and a second pair of opposing tendons is connected to a second base, to move the opposing blades around the common distal rotation axis.
[0055] According to one embodiment, the first mounting base portion, for example, the blade holder link base portion, integrally includes at least a first end seat portion that receives the first anti-tendon pair, and the second mounting base portion integrally includes at least a second end seat portion that receives the second anti-tendon pair.
[0056] The first and second antagonistic tendon pairs are adapted to slide longitudinally on the one or more convex wire surfaces of the connecting link and the one or more convex wire surfaces of the support link, if a connecting link is provided, and are adapted to wrap around / unwrap without sliding on the respective convex wire surfaces of the blade holder link base, i.e., the first base, or the reaction link, i.e., the second base, thereby opening / closing 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 the free end of the first leg and defines the first end seat portion in the axial direction, and a second cantilevered drag leg extends from a second root portion forming the free end of the second leg and defines the second end seat portion in the axial direction, and the first and second cantilevered legs each include an abutment and a drag wall, respectively, which are positioned as undercuts to the respective end seats that act as draging abutments for the respective tendon ends. In such cases, a first axial distance is identified between the first cantilever leg and the surface of one or more convex woven surfaces of the support structure, for example, the support link, and this first distance is constant for any cutting state, and a second distance is identified between the second cantilever leg and the surface of one or more convex woven surfaces of the support structure, for example, the support link, in a direction parallel to a common distal rotation axis, and this first distance can be constant for any cutting state.
[0058] The first distance and the second distance can be made equal to each other.
[0059] The first distance and / or the second distance may be 0.
[0060] According to one embodiment, when in operation, the overall sliding friction force exchanged between each tendon and all the wire-woven surfaces of the links on which the tendons slide is much smaller than the tensile force transmitted by the same tendon, achieving 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 tendons 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 polymer material and the links can be made of metal material, and the convex wire-woven surfaces of the links with parallel generath are smooth, which can reduce the longitudinal sliding friction of the tendons on the links. For example, the wire-woven surfaces of the links are obtained by wire electrolytic erosion.
[0061] Preferably, all convex wire woven surfaces of the connecting link, support link, first root pulley, and second root pulley do not have longitudinal channels. Therefore, the actuating tendon does not slide within a concave channel.
[0062] A third pair of antagonistic tendons can be provided to allow the support link to move relative to the connecting link about the common proximal rotation axis, and the support link is provided with at least a third end seat to receive the tendon ends of the third pair of antagonistic tendons. Preferably, the acting tendons of the third pair of support links of the antagonistic tendons wrap around / unwrap without longitudinal sliding on the one or more convex wire woven surfaces of the support link, so that the convex wire woven surfaces act as pulley surfaces for the acting tendons of the third pair of antagonistic tendons.
[0063] According to one aspect of the present invention, a rotary joint for the 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 needle holder / cutter-type surgical instruments will become apparent from the following description of preferred embodiments, which are non-limiting and given as examples, with reference to the accompanying drawings (it should be noted 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 furthermore, for the purpose of brevity and reducing the total number of drawings, features of multiple embodiments may be shown using given drawings, and not all elements of the drawings are necessary for a given embodiment). [Brief explanation of the drawing]
[0066] [Figure 1] Anisotropic projection of a robotic surgical system according to one embodiment. [Figure 2] Anisotropic projection view of a needle holder / cutter-type surgical instrument according to one embodiment. [Figure 3] An asymmetrical projection of a portion of a needle holder / cutter-type surgical instrument, which has an end effector at the distal end of the shaft, illustrating the working tendon. [Figure 4] An unequal-angle projection view of the end effector of a needle holder / cutter-type surgical instrument according to one embodiment, illustrating the operational tendon. [Figure 5A] A schematic diagram illustrating the end effector of a needle holder / cutter-type surgical instrument in one of two operational configurations according to one embodiment, illustrating the operational tendon. [Figure 5B] A schematic diagram illustrating the end effector of a needle holder / cutter-type surgical instrument in the other of two operating configurations according to one embodiment, illustrating the operating tendon. [Figure 6] An asymmetrical projection view of a portion of the end effector of a needle holder / cutter-type surgical instrument according to one embodiment. [Figure 7] An asymmetrical projection view of a portion of the end effector in Figure 6, showing the components in an exploded view. [Figure 8A]An unequal angle projection diagram of a needle holder / cutter-type surgical instrument with an end effector at the distal end of the shaft, illustrating the working tendon in a schematic manner according to one embodiment. [Figure 8B] Figure 8A shows a schematic diagram illustrating the operating tendon, which is the end effector. [Figure 9] An unequal-angle projection diagram of a needle holder / cutter-type surgical instrument equipped with an end effector, illustrating the operating tendon in a schematic manner according to one embodiment. [Figure 10] Plan view showing a portion of the end effector of a needle holder / cutter-type surgical instrument according to one embodiment. [Figure 11] Plan view of a portion of the end effector in Figure 10, showing the assembled components in a cross-sectional configuration. [Figure 12] An unequal-angle projection view of a portion of the end effector of the cutting configuration shown in Figure 11. [Figure 13A] Vertical elevation view of a portion of the blade links in the end effector, Figure 10. [Figure 13B] Vertical elevation view of a portion of the blade holder link of the end effector shown in Figure 10 according to one embodiment. [Figure 14] This figure schematically shows the expected configurations of blades and opposing blade surfaces with various mechanical cutting interference configurations according to one embodiment. [Figure 15A] Vertical elevation view of the end effector in Figure 11 from the viewpoint indicated by arrow A. [Figure 15B] Vertical elevation view of the end effector in Figure 11 from the viewpoint indicated by arrow B. [Figure 16] An asymmetrical projection diagram showing a portion of the end effector in Figure 11 in an exploded view. [Figure 17A] Figure 11 shows a portion of the end effector in a possible cutting sequence of the suture wire. [Figure 17B] Figure 11 shows a portion of the end effector in a possible cutting sequence of the suture wire. [Figure 17C] Figure 11 shows a portion of the end effector in a possible cutting sequence of the suture wire. [Figure 18]Plan view showing a portion of the end effector of a needle holder / cutter-type surgical instrument according to one embodiment. [Figure 19] Plan view showing a portion of the end effector of a needle holder / cutter-type surgical instrument according to one embodiment. [Figure 20] Figure 19 shows the end effector in the cross-sectional form of the assembled configuration. [Figure 21] Asymmetrical projection of a portion of the end effector in the assembled configuration, Figure 19. [Figure 22] Vertical elevation view of the opposing blade links of the end effector in Figure 19. [Figure 23] Vertical elevation view of a portion of the second tip link of the end effector in Figure 19. [Figure 24] An asymmetrical projection diagram showing a portion of the end effector in Figure 19 in an exploded view. [Figure 25] Vertical elevation view of a partially assembled configuration of the end effector shown in Figure 24. [Figure 26] Electron microscope image showing the blade link and opposing blade link arranged on the obverse of a 5 euro cent coin. [Figure 27] Vertical elevation view of a portion of the end effector of a needle holder / cutter-type surgical instrument according to one embodiment. [Figure 28A] Vertical elevation view of a portion of the first tip link of the end effector of a needle holder / cutter-type surgical instrument according to one embodiment. [Figure 28B] Enlarged view of the blade link in Figure 28A from the viewpoint indicated by arrow B. [Figure 28C] Detailed unequal angle projection of the first tip link shown in Figure 28A. [Figure 29A] Vertical elevation view of a blade link according to one embodiment [Figure 29B] Vertical elevation view of a opposed blade link according to one embodiment [Figure 29C] Vertical elevation view of a portion of the end effector of a needle holder / cutter-type surgical instrument, with the assembled configuration of the blade links in Figure 29A and the opposing blade links in Figure 29B. [Figure 30]Plan view showing a partial cutting configuration of the end effector of a needle holder / cutter-type surgical instrument according to another embodiment. [Figure 31] Electron microscope image showing the end effector of a needle driver / scissors gripper type surgical instrument at the distal end of the shaft according to one embodiment. [Figure 32] A diagram showing the rotary joint of the cutting joint of an articulated end effector of a surgical instrument according to one embodiment. [Modes for carrying out the invention]
[0067] Throughout this specification, any reference to “embodiments” means that a particular feature, structure, or function described in relation to an embodiment is included in at least one embodiment of the present invention. Therefore, “in one embodiment” in various parts of this specification does not necessarily refer to the same embodiment. Furthermore, any given feature, structure, or function, as shown in different drawings, can be combined in any suitable manner in one or more embodiments unless otherwise specified.
[0068] According to a general embodiment, a surgical instrument 1 is provided. The surgical instrument 1 is a needle holder / cutter type (or, in commonly used technical terms, a "needle driver / suture cutter type") surgical instrument 1.
[0069] The needle holder / cutter type surgical instrument 1 is particularly suited to robotic surgery, but is not uniquely intended for this purpose and may be connectable to a robotic manipulator 63 equipped with an electric actuator of a robotic surgical 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 devices, as well as actuators.
[0070] The robotic surgical system 101, equipped with the needle holder / cutter-type surgical instrument 1, is particularly suited to, but not exclusively intended for, robotic microsurgical procedures. The robotic surgical system 101 can also be used for robotic laparoscopic surgery.
[0071] The needle holder / cutter type surgical instrument 1 includes an articulated end effector 9, or in other words, an articulated end 9. According to one embodiment, the needle holder / cutter type surgical instrument 1 comprises a shaft 7 and the articulated end effector 9 located at the distal end 8 of the shaft 7. The shaft 7 is not necessarily a rigid shaft; for example, it may be a bendable shaft and / or an articulated shaft, but according to a preferred embodiment, the shaft 7 is a rigid shaft. For example, as shown in Figure 2, the proximal interface portion 61 or the rear end portion 61 of the surgical instrument 1 can be provided at the proximal end 62 of the shaft 7 to form an interface with the robotic manipulator 63 of the robotic surgical system 101. A sterile barrier can be interposed between the robotic manipulator and the proximal interface portion 61 of the surgical instrument. For example, the proximal interface portion 61 may include a set of interface transmission elements for receiving drive movements applied by the robotic manipulator 63 and transmitting them to the articulated end effector 9. According to one embodiment, the needle holder / cutter-type surgical instrument 1 is detachably 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 multiple links articulated with one or more rotary joints. These links are movable within the shaft 7 by multiple pairs of antagonistic actuating tendons that extend from the proximal interface 61 to the articulated end effector 9 and terminate at terminal seats provided on at least a portion of the links of the articulated end effector 9. One or more pairs of antagonistic actuating tendon pairs may consist of a single tendon that forms a reciprocating path from the proximal interface 61 of the instrument to the links of the articulated end effector of the instrument.
[0073] All links forming the articulated end effector 9 are not necessarily articulated with respect to the distal end 8 of the shaft 7, i.e., they are not necessarily movable. For example, the end effector 9 may be a "roll-pitch-yaw" type articulated cuff, according to the terminology widely used in this field. For example, the end effector 9 may be a "snake" type articulated end effector 9, i.e., it may have a number of coplanar and / or nonplanar rotational joints.
[0074] The articulated end effector 9 of the needle holder / cutter-type surgical instrument 1 may include a support structure having two projections 3, 4, which form a support fork. Preferably, the support fork (or support structure) is made from a single piece, i.e., the two projections 3, 4 are integrally formed. According to a preferred embodiment, the articulated end effector 9 includes a support link 2 which includes the support fork having the two projections 3, 4.
[0075] Preferably, the term "link" refers to a body made from a single component, i.e., a monoblock body.
[0076] For example, according to the embodiment shown in Figure 3, the support link 2, which includes the support forks with projections 3 and 4, is a separate component from the shaft 7 and is articulated to the shaft 7 by interposing the support link 2 between the support link 2 and the distal end 8 of the shaft 7 of another connecting link 60. The connecting link 60 is firmly fixed to the distal end of the shaft 7 by a fixing device 64 (shown as a pair of fixing pins 64 in the illustrated example, but instead the fixing device 64 may comprise a plug, rivet, staple, one or more threaded elements, connecting profile, etc.) and comprises two projections 60.1, 60.2 that articulate to the support link 2 with respect to the shaft 7 around a common proximal rotation axis PP, or pitch axis PP (the term "pitch" is used arbitrarily here and can refer to any direction of the common rotation axis PP).
[0077] For example, according to the embodiments shown in Figures 8A and 8B, the support link 2, which includes the support forks with projections 3 and 4, is a separate component from the shaft 7 and is firmly fixed to the shaft 7 by a fixing device 64 (a pair of pins in the illustrated example), i.e., it is not an articulated joint. Therefore, in such a case, projections 3 and 4 are integral with the distal end 8 of the shaft 7.
[0078] For example, according to the embodiment shown in Figure 9, the support structure or fork including the projections 3 and 4 is formed integrally with the distal end 8 of the shaft 7. In such a case, the projections 3 and 4 are integral with the distal end 8 of the shaft 7, and the articulated end effector 9 further comprises the distal end 8 of the shaft 7 having the two projections 3 and 4; that is, for the purposes of the present disclosure, in this embodiment, the distal end 8 of the shaft 7 having the two projections 3 and 4 is understood to belong to the articulated end effector 9.
[0079] The articulated end effector 9 of the needle holder / cutter-type surgical instrument 1 further comprises a first tip link 10 (or blade holder link 10) and a second tip link 20 (or reaction link 20). Preferably, the first tip link 10 and the second tip link 20 each have an elongated body, and the elongated bodies of the first tip link 10 and the second tip link 20 are constrained to each other at their respective proximal or root portions 11, 21 and rotate around a common rotation axis 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 tip link 10 integrally comprises a first proximal mounting base 11, a first free distal end 12, and a first gripping surface 13 between them, and the body of the second tip link 20 integrally comprises a second proximal mounting base 21, a second free distal end 22, and a second gripping surface 23 between them. Connection portions 81 and 82 of each tip link 10 and 20 can be defined between the mounting base 11 or 21 and the respective gripping surfaces 13 and 23. When in use, the first gripping surface 13 of the first tip link 10 and the second gripping surface 23 of the second tip link 20 face each other, face each other when rotating, and move in contact with each other, intended to perform a gripping action on, for example, a surgical needle. Each gripping surface 13 and 23 can be machined according to known techniques, and raised and recessed portions can be formed to enhance gripping ability.
[0081] Preferably, the articulated end effector 9 of the needle holder / cutter-type surgical instrument 1 further comprises a blade link 30 or blade 30 integrally having a third proximal attachment base 31 and a cutting edge 34. The cutting edge 34 is elastically deformable by bending and can be sharpened. That is, the cutting edge 34 can be sharpened to have a locally reduced thickness and / or a sharp cross-sectional shape relative to the thickness of the body of the blade link 30. By providing the blade 30, the articulated end effector 9 of the needle holder / cutter-type surgical instrument 1 is enabled to perform a useful cutting operation for cutting a suture wire 6 that can be connected to a surgical needle.
[0082] Preferably, the bodies of the first tip link 10 and the second tip link 20 each have an elongated shape in the longitudinal direction extending from their respective mounting bases to their respective free ends, their respective gripping surfaces are positioned close to their respective free ends, and the bases 11, 21, and 31 of the first tip link 10, the second tip link 20, and the blade link 30 are adjacent to each other. At the connection portions 81 and 82 of the bodies of the first tip link 10 and the second tip link 20, respectively, which are interposed longitudinally between their respective bases 11 and 21 and their respective gripping surfaces 13 and 23, axial and longitudinal seating portions 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 tip link 10 and the second tip link 20 are adjacent to each other at their respective base portions 11 and 21 and their respective connecting portions 81 and 82, and overlap at their respective gripping surfaces 13 and 23, while the blade link 30 is adjacent to the base portions 11 and 21 of the first tip link 10 and the second tip link 20 at its base portion 31, and is adjacent to the connecting portions 81 and 82 of the first tip link 10 and the second tip link 20, and is interposed between them.
[0083] In a preferred embodiment, the root of the blade link 31 is interposed between the roots 11, 21 of the first tip link 10 and the second tip link 20. Preferably, the body of the blade link 30 is also longitudinally elongated and includes a blade link end 32, which is shorter than the bodies of the first tip link 10 and the second tip link 20 and extends substantially longitudinally from the adjacent mounting roots 11, 21 to the gripping surface areas 13, 23 of the first tip link 10 and the second tip link 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 tip link 10 and the second tip link 20.
[0084] According to one embodiment, the blade link 30 is manufactured by forming, i.e., cutting, a suitably substantially flat elastic sheet or strip. For example, the elastic sheet or strip is made of spring steel and can be formed by wire electrolytic erosion (WEDM) and / or photoetching and / or laser cutting and / or chemical etching. Preferably, the elastic sheet or strip is sharpened at one edge to form the cut edge 34 of the blade link 30. The sharpening process can be carried out by wire electrolytic erosion (WEDM) and / or grinding, for example, by stone or diamond grinding. According to one embodiment, first, the elastic sheet or strip is formed by wire electrolytic erosion (WEDM) in a step flowing in a direction substantially perpendicular to the plane on which the sheet or strip lies, and then one or more edges of the formed sheet or strip are sharpened by wire electrolytic erosion (WEDM) in a step flowing in a direction not perpendicular to the plane on which the formed sheet or strip lies.
[0085] According to one embodiment, the body of the blade link 30 is positioned on a two-dimensional main stretch, i.e., preferably a flat or arched lying surface, and has a substantially reduced thickness compared to the stretch on the said flat or arched lying surface.
[0086] According to one embodiment, the cutting edge 34 of the blade link 30 is preferably substantially straight on a flat or arched lying surface, thus avoiding the creation of a concave surface on the lying surface of the body of the blade link 30.
[0087] Preferably, the thickness of the blade link 30 is significantly smaller than the thickness of the first and second tip links 10 and 20, and is selected so that the blade is elastically bendable in the direction of thickness relative to the longitudinal extension of the blade link 30 when in operation. 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 the flexibility of the cutting edge 34 of the blade link 30, is intended in the direction of thickness, i.e., perpendicular to the lying surface of the blade link. Such a lying surface of the body of the blade link 30 can substantially correspond to the lying surface of a starting metal strip or sheet that is appropriately machined to form the blade link 30, but according to a possible embodiment, the body of the blade link 30 is compelled to have an arched, i.e., concave structure with a concave surface facing in the direction of entering and exiting the lying surface of the starting elastic strip or sheet. In this case, the lying surface of the blade link body becomes an arched surface.
[0088] The blade link 30, and therefore the cutting edge 34 of the blade link 30, is not necessarily elastically deformable in a horizontal plane; that is, it does not necessarily include bendability in a direction perpendicular to its thickness.
[0089] The material of the blade link 30 may be different from the material of the first tip link 10 and / or the second tip link 20. For example, the blade link 30 can be made of spring steel. For example, the first tip link 10, the second tip link 20 and the support link 2, if present, can be made of a single metallic material, such as steel. For example, the opposing blade link 40, if present, can 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 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 thickness of the second root portion 21 of the second tip link 20 can be between 1 / 5 and 1 / 20. In absolute terms, the thickness of the blade link 30 can be between 0.1 mm and 1 mm.
[0091] The support structure including the protrusions 3 and 4 (for example, the support structure formed by the support link 2 or the distal end 8 of the shaft), the first tip link 10, the second tip link 20, and the blade link 30 are made of separate parts, and the blade link 30 rotates integrally with the first tip link 10. Thus, the first tip link 10 functions as a blade holder link. This allows the cutting edge 34 to rotate integrally with the first gripping surface 13 and the first free end 12 of the first tip link 10, and to be elastically bent, so that the cutting edge 34 can elastically deform relative to the first tip link 10 which rotates integrally when in operation. The elastic deformation of the cutting edge 34 preferably occurs transversely to the longitudinal extension direction of the elongated body of the first tip link 10, i.e., transverse to the direction in which the first proximal mounting root 11 and the first distal free end 12 of the first tip link 10 are joined, 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 with projections 3 and 4 of the support structure around the common rotation axis YY, which defines the directional degrees 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 its linear extension) can pass through the two projections 3 and 4 and the first, second and third proximal mounting root portions 11, 21, and 31, and be defined by the 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 with each other around the common rotation axis YY, defining the relative 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. As a result, the group formed by the second free end 22 and second gripping surface 23 of the second tip link 20, the cutting edge 34 and first free end 12 of the blade link 30, and the first gripping surface 13 of the first tip link 10 is relatively movable in the opening and closing direction, i.e., in the direction of moving closer to or further apart from each other.
[0093] According to one embodiment, the opposing first gripping surface 13 and the second gripping surface 23 that face each other during rotation act as the closed stroke ends 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 to the common meaning of the terms, as indicated by the arrows in Figure 2. Preferably, for clarity of presentation, an axial direction is defined that coincides with or is parallel to the direction of the common rotation axis YY. Preferably, for clarity of presentation, an internal axial direction is also defined with respect to the first tip link 10, facing the second tip link 20, and similarly, with respect to the second tip 20, the internal axial direction is opposite, i.e., facing the first tip 10. Preferably, for clarity of presentation, the term “radial direction” refers to a direction substantially perpendicular to and incident to the common rotation axis YY. Preferably, for clarity of expression, it also means the longitudinal direction which substantially coincides overall with the extension and unfolding direction of the needle holder / cutter type surgical instrument 1, and also locally coincides with the longitudinal extension of the elongated body of the first tip link 10 and / or coincides with the longitudinal extension of the elongated body of the second tip 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 / closing degrees 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 face each other and are substantially aligned when rotated. The first gripping side P1 and the second gripping side P2 are preferably mainly aligned, but the first gripping surface 13 and the second gripping surface 23 can only contact each other when the opening / closing degrees of freedom G is in a closed configuration. In other words, the gripping surfaces 13 and 23 are formed on the inward axial projections of the first gripping side P1 of the first tip link 10 and the second gripping side P2 of the second tip link 20, respectively.
[0095] As previously mentioned, the support structure (e.g., formed by the support links 2 or 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 joined together by a common rotation axis YY, i.e., a common rotation axis YY constrained to rotate with respect to the common rotation axis yaw YY axis (e.g., four links 2, 10, 20, 30 or three links 10, 20, 30 and the distal end 8 of the shaft 7 including two protrusions 3, 4) (the term "yaw" is used here arbitrarily and can indicate any orientation of the common rotation axis YY, but according to a preferred embodiment, it means a common rotation axis yaw YY axis that is non-parallel to the proximal common rotation axis pitch PP axis already mentioned above, and preferably perpendicular to the pitch PP axis of the proximal common rotation axis).
[0096] Further links and components may be present within the end effector 9, but according to one embodiment, the articulated end effector 9 is precisely composed of the four components articulated together on the common axis YY and appropriately movable by an actuation tendon. According to one embodiment, the articulated end effector 9 is precisely composed of the four components articulated together on the common axis YY and appropriately movable by an actuation tendon, and a further component which is an articulation pin 5 defining the common axis YY (a total of five components, with the actuation tendon excluded from the count).
[0097] According to one embodiment, the articulated end effector 9 is precisely composed of three parts articulated with respect to the support structure along the common axis YY, and an additional part which is an articulated pin 5 defining the common axis YY (a total of four parts, with the actuation tendon excluded from the count). The three parts are the first end link 10, the second end link 20, and the blade link 30. The actuation tendon can be connected to the first and second links.
[0098] According to one embodiment, the articulated end effector 9 is precisely composed of the four parts (i.e., the four links 2, 10, 20, and 30) articulated along the common axis YY, a further part which is an articulated pin 5 defining the common axis YY, and a connecting link 60 which has a shaft 7 articulated with respect to the support link 2 at the proximal common rotation axis pitch PP by a further proximal articulated pin 65 defining the proximal common rotation axis pitch PP (a total of seven parts, with the actuating tendon excluded from the count). According to this embodiment, when the common rotation axis pitch PP is non-parallel (preferably orthogonal) to the common rotation axis yaw YY, an articulated cuff can be obtained at the distal end of the shaft 7, in which case the rotation axis pitch PP is non-parallel to the common rotation axis yaw YY, preferably orthogonal to the common rotation axis yaw YY, and the articulated cuff is given pitch, yaw, and gripping degrees of freedom G, the gripping degrees of freedom G being adapted to manage gripping and cutting. When the connecting link 60 is formed integrally with the distal end 8 (not shown) of the shaft 7, the articulated end effector 9 still consists 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 articulated pins 5 and 65.
[0099] The roll R, which is integrated with the shaft 7 and preferably with the rear end portion 61, has degrees of freedom, for example, it can provide a degree of freedom of the roll R that allows the entire surgical instrument 1 to rotate around the longitudinal extension axis XX of the shaft 7.
[0100] As those skilled in the art will see, minimizing the number of parts greatly simplifies the assembly of the articulated end effector 9 of the needle holder / cutter-type surgical instrument 1, making it suitable for extreme miniaturization. In particular, by avoiding the provision of elastic preloading elements in the axial direction (such as the Belleville elastic washer attached to the articulating pin 5), i.e., in the direction of the common rotation axis YY between the projections 3 and 4 of the support structure, the assembly of the parts can be simplified. Thus, extreme miniaturization of the articulated end effector 9, and consequently the cross-section of the shaft 7, can be promoted, while ensuring sufficient strength and resistance to stresses that may occur under operating conditions.
[0101] More preferably, an opposing blade surface 24 is provided that rotates integrally with the second tip link 20. In other words, the articulated end effector 9 further comprises the opposing blade surface 24 whose rotation is 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 the second tip link 20, for example, as shown in Figure 12.
[0102] For example, according to the embodiment shown in Figure 21, an opposing blade link 40 is provided, which is a separate component from the second tip link 20 and can rotate integrally with the second tip link 20. The opposing blade link 40 comprises the opposing blade surface 24 and a fourth proximal mounting root 41 articulated on the common rotation axis YY.
[0103] The opposing blade surface 24 is adapted to contact 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 state of mechanical interference contact to perform the cutting operation. Preferably, the cutting edge 34 of the blade link 30 is sharpened and coplanar with the axially facing blade surface 35 of the blade link 30, which is positioned axially opposite to the opposing blade surface 24. During the cutting operation, at least a portion of the blade surface 35 can contact the opposing blade surface 24, thereby substantially causing direct friction 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 the inward axial direction and is preferably included in the connection portion 82 of the elongated body of the second tip link 20, thereby enabling mechanical interference contact with the cutting edge 34 of the blade to perform the cutting operation.
[0105] In a preferred embodiment, the opposing blade surface 24, which rotates integrally with the second tip link 20, protrudes toward the rotational footprint of the blade link 30 body so as to elastically bend the blade link 30 when it mechanically interferes with the cutting edge 34. In other words, the opposing blade surface 24 protrudes in the inaxial direction. The protrusion of the opposing blade surface 24 is emphasized distally, i.e., away from the common rotation axis YY along the longitudinal extension of the second tip link 20, and preferably the protrusion is greatest near or at the distal end 32 of the blade link 30. In a preferred embodiment, the protrusion of the opposing blade surface 24 is gradually obtained by tracing the opposing blade surface distally, for example, progressively increasing the distal portion that enhances the protrusion.
[0106] Accordingly, according to one embodiment, the first tip link 10 has an axially inward surface 18 inclined away from the body of the blade link body 30, and defines an axially deformable recess 14 (or deformable seat 14) adapted to accommodate the body of the blade link 30 when elastically bent by the action of a protruding opposing blade surface 24 that rotates integrally with the second tip link 20 during the cutting operation. Thus, both the opposing blade surface 24 and the axially inward surface 18 face the blade link 30 and both contact the blade link 30 during the cutting operation. The axially inward surface 18 preferably belongs to the connecting 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 functions as an axial stroke end contact surface for deformation of the blade link 30 when it is deformed by being bent by the opposing blade surface 24 during the cutting operation. The contours of the protruding surface of the opposing blade 24 and the axially oriented surface 18 of the first tip link 10 may be parallel to each other, and in one embodiment may be corresponding and identical.
[0108] Preferably, the term “rotational approach footprint” means the volume of space that the body of the element can occupy during the relative closing rotational movement of the gripping degrees of freedom G. Thus, the term “rotational approach footprint of blade link 30” means the volume of space that can be occupied by the body of blade link 30 during the relative closing rotational movement of the gripping degrees of freedom G. Similarly, “rotational approach dimension of the first link of tip 10” means 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 degrees of freedom G, and “rotational approach dimension of the second tip link 20” means 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 degrees of freedom G.
[0109] The mechanical interference contact between the cutting edge 34 and the opposing blade surface 24 that determines the cutting motion simultaneously causes the body of the blade link 30 to bend. The bending deformation of the body of the blade link 30 during the cutting motion is preferably directed axially toward 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 motion is directed, for example, substantially parallel to the common rotation axis YY.
[0110] At least one contact point POC between the cutting edge 34 and the opposing blade surface 24 preferably changes position and / or size as a function of the opening angle of the grip opening / closing degree of freedom G, for example, as schematically shown in Figure 14. In particular, at relatively large opening angles (e.g., angles in the range of 20°-30°), contact occurs at the more proximal portion of the cutting edge 34, i.e., the portion closer to the third mounting root 31, and as the contact moves distally, the opening angle gradually decreases, increasing the bending due to the elastic deformation of the body of the blade link 30 relative to the third root 31 of the blade link 30. Thus, the deformation configuration of the blade link 30 when the first tip link 10 and the second tip link 20 are in a substantially closed configuration bends to the maximum extent, and in any case, bends more than the deformation configuration of the blade link 30 when the first link tip 10 and the second tip link 20 are in a partially closed configuration and a partially open configuration. Preferably, when the opening angle is at its maximum and the blade is free, the blade is straight and the blade link has a substantially planar configuration.
[0111] To activate the degrees of freedom of the articulated end effector 9 by moving the links of the articulated end effector 9 around a proximal common axis and / or distal rotational common axis, i.e., pitch PP and / or yaw YY, the needle holder / cutter type surgical instrument 1 preferably comprises a plurality of pairs of antagonistic acting tendons extending from the rear end portion 61 through the shaft 9 to the articulated end effector 9 and terminating at least a portion of the links of the articulated end effector 9, as described below.
[0112] In a preferred embodiment, the first tip link 10 integrally comprises a first end seat 15 for receiving a first pair of antagonistic tendons 71, 72, and the second tip link 20 integrally comprises a second end seat 25 for receiving a second pair of antagonistic tendons 73, 74. As those skilled in the art will see, in this preferred embodiment, each of the first and second pairs of antagonistic tendons comprises an open-acting tendon 71, 73 and a closed-acting 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, assembly is simplified, and miniaturization is promoted. Furthermore, the third root portion 31 of the blade link 30 can be made very thin, or at least thin, as a bendable portion, which simplifies the elastic fabrication of the blade link 30 and at the same time allows for precise characterization of its mechanical properties that function for cutting operations. Furthermore, according to a preferred embodiment, each end seat 15, 25 functions as the end seat of two antagonist tendons included in each pair of antagonist tendons, helping to minimize the number of operations that must be performed for each of the tip links 10, 20, and thus promoting miniaturization. Thus, the third blade link 30 has no end seat and is dragged by the first tip link 10 during rotation. If a fourth link 40 is present, the fourth link 40 is dragged by the second tip link 20 during rotation and has no end seat. This allows the number of actuating tendons to be kept small and the number of end seats to be kept to a minimum, thus promoting miniaturization.
[0113] According to one embodiment, the first end seat portion 15 of the first end link 10 and the second end seat portion 25 of the second end link are defined by cantilever drag legs 77, 78 that extend longitudinally from their respective root portions 11, 21, adjacent to the elongated bodies of their respective end links 10, 20, and in particular adjacent to their respective link portions 81, 82. Thus, the end seat portions 15, 25 of the first and second end links 10, 20 are substantially radial slots, preferably longitudinal slots, and have radially facing bottom walls formed by their respective mounting root portions 11, 21.
[0114] Preferably, the extensions of the cantilever drag legs 77, 78 between the back sides D1, D2 and the cut sides P1, P2 of the respective ends 10, 20 are substantially identical so as to face the edge surfaces of the respective end seats 15, 25. The end seats 15, 25 are arranged side by side at the same height and act as stopping and resistance contact points for the respective tendon ends 70 of each pair of acting tendons 71, 72, 73, 74 of the opposing tendon. The tendon end 70 of each acting tendon can be, for example, an enlarged portion formed by a knot or boss that abuts against the edge wall of the respective end seats 15, 25. In other words, the edge walls of each end seat 15, 25 are edge walls formed by the respective cantilever drag legs 77, 78 and the respective connectors 81, 82, and comprise an edge wall facing the respective back sides D1, D2 that acts as a closing resistance edge wall, and an edge wall facing the opposite side of the same respective cantilever drag legs 77, 78, i.e., the opposite side of the respective connectors 81, 82 that faces the respective gripping sides P1, P2 and acts as an opening resistance edge wall. Thus, the edge walls of the end seat 15, 25 are positioned as undercuts for the respective tendon ends 70 of each end seat 15, 25, and each end seat 15, 25 is a through end seat, preferably having an access opening facing longitudinally toward the free ends 12, 22 of the respective end links 10, 20. Therefore, the distal portions of the actuating tendons 71, 72, 73, and 74 of the first and second opposing tendon pairs intersect and / or overlap within their respective end seats 15 and 25, causing their respective tendon ends 70 to abut against edge walls that are circumferentially undercut and positioned thereto, thereby providing resistance to the rotation of the first or second end link 10 or second end link 20 in the opening and / or closing direction of the opening and closing degree of freedom G.
[0115] In a preferred embodiment, the first root portion 11 of the first tip link 10 and the second root portion 21 of the second tip link 20 each have at least one pulley surface 79, 80 facing away from the common rotation axis YY, the pulley surface facing away from the common rotation axis YY can wrap around the respective resistance seat portions 15, 25 from opposite sides in the circumferential direction and continue to face radially within the respective end seat portions 15, 25, i.e., form a bottom wall facing away from the common rotation axis YY. As a result, the distal portions of the tendons 71, 72, 73, 74 of the first and second antagonistic tendon pairs near the respective tendon ends 70 wrap around the at least one pulley surface 79, 80 which is a convex wire woven surface having a generatrix parallel to the rotation axis YY.
[0116] According to a preferred embodiment, at least one pulley surface 79 of the first root portion 11 and at least one pulley surface 80 of the second root portion 21 are all convex wire woven surfaces parallel to the common rotation axis YY, having parallel genera that do not include circumferential channels or grooves for guiding or holding the tendon. At least one pulley surface 79, 80 may be interrupted by radial cut channels 19, 29, if present.
[0117] In an embodiment in which the support link 2 is articulated to the distal end 8 of the shaft 7, the needle holder / cutter-type surgical instrument 1 further comprises a third pair of antagonistic tendons 75, 76 for moving the support link 2 around the common proximal rotation axis PP. Thus, the support link 2 may comprise at least a third end seat 67 for receiving the tendon ends 70 of the third pair of antagonistic tendons 75, 76. For example, according to the embodiments shown in Figures 3 and 4, the at least third end seat 67 of the support link 2 is a single end seat that passes axially through the body of the support link 2, i.e., directly parallel to the common distal rotation axis YY, forming a contact wall and a resistance wall for the tendon ends 70 positioned as undercuts for the respective working tendons 75, 76 of the third pair of antagonistic tendons 75, 76, similar to those 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, with one seat for each tendon 75, 76 of the third opposing tendon pair.
[0118] According to a preferred embodiment, the support link 2 has parallel generatrixes and comprises one or more convex woven surfaces 84, 86, all parallel to a common proximal rotation axis PP, the acting tendons 71, 72, 73, 74 of the first and second antagonistic tendon pairs slide on the one or more convex woven surfaces 84, 86 of the support link 2 during the operation of the first tip link 10 and / or the second tip link 20, and the one or more convex woven 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 may also comprise one or more convex woven surfaces parallel to a common distal rotation axis YY (not shown) on which the acting tendons 71, 72, 73, 74 of the first and second antagonistic tendon pairs slide during the operation of the first tip link 10 and / or the second tip link 20.
[0119] Having parallel generatrixes, one or more identical convex woven surfaces 84, 86, all parallel to the common proximal rotation axis PP of the support link 2, can also act as pulley surfaces for the acting tendons 75, 76 of the third antagonist tendon pair, and the support link 2 is articulated with respect to the distal end 8 of the shaft 7 around the common proximal rotation axis PP. The one or more convex woven surfaces 84, 86 of the support link 2 extend on both sides of the support link 2. According to one embodiment, the pulley surface for the acting tendons 75, 76 of the third antagonist tendon pair is formed by the inner surface of the end seat portion 67 of the support link 2.
[0120] In an embodiment in which the connecting link 60 is provided, the connecting link 60 has parallel generatrixes and comprises one or more convex wire woven surfaces 85, 87 all parallel to a common proximal rotation axis PP, and the actuating tendons 71, 72, 73, 74, 75, 76 of the first, second, and third antagonist tendon pairs slide on the one or more convex wire woven surfaces 85, 87 of the connecting link 60. The one or more convex woven surfaces 85, 87 of the connecting link 60 extend to both sides of the connecting link 60, and between the connecting link 60 and the support link 2, the tendons 71, 72, 73, 74, 75, 76 of the first, second, and third antagonistic tendon pairs slide on or wrap around one or more convex woven surfaces 84, 86 of the support link 2 that face opposite to the woven surfaces 85, 87 of the connecting link 60, which they slide proximal to, or intersect each other without sliding. For example, the one or more convex woven surfaces 84, 86 of the support link 2 are interposed between the projections 60.1, 60.2 of the link 60 and are oriented opposite to a common proximal rotation axis PP.
[0121] The convex wire woven surfaces 75, 76, 84, 85, 86, and 87 having parallel generatrixes of the links that slide or wind in contact with the tendons 71, 72, 73, 74, 79, and 80 are preferably all outer surfaces of each link.
[0122] The working tendons 71, 72, 73, 74, 75, and 76 are preferably polymer tendons formed from intertwined polymer fibers.
[0123] In 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 interposed overall between the two projections 3, 4 of the support structure and is in direct contact with the two projections 3, 4. This avoids relative movement between the root portions and between each root portion and projection, and therefore, if an articulating pin 5 is provided, relative sliding along the articulating pin 5 between the root portions and projections is avoided during the elastic deformation of the blade link 30. In other words, the root portions and projections are preferably arranged side by side, in direct contact with each other, with no elastic reaction force between them, and even if they are distal, i.e., at a predetermined longitudinal distance with respect to the common axis of rotation YY, the geometric shape of each link may cause the rotational approach dimensions of each link to overlap or interfere. For example, gripping contact occurs between the first gripping surface 13 of the first tip link 10 and the second gripping surface 23 of the second tip link 20. Similarly, cutting interference contact occurs between the cutting edge 34 of the blade link 30 and the opposing blade surface 24 that rotates integrally with the second tip link 20.
[0124] Similarly, in an elastically deformed configuration, when the opposing blade surface 24 is locally translated with respect to the rotational footprint of the first tip link 10 in a direction transverse to the longitudinal extension direction of the body of the first tip link 10, it can at least partially overlap with the rotational approach footprints of the body of the first tip link 10 and the body of the blade link 30. However, according to a preferred embodiment, the opposing blade surface 24 and the axially inward 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, if there is an opposing blade surface 24 belonging to an opposing blade link 40 which is made of a separate part relative to the second tip link 20 and in particular has a fourth proximal mounting root 41, the group formed by the first root 11 of the first tip link 10, the second root 21 of the second tip link 20, the third root 31 of the blade link 30, and the fourth root 41 of the opposing blade link 40 is interposed as a whole between the two protrusions 3, 4 of the support structure and is in close contact with them directly.
[0126] This package arrangement at the base provides a reaction force against the elastic bending of the blade body during cutting, while also avoiding the need for elements that exert elastic action between the base sections. As a result, assembly is simplified and extreme miniaturization is promoted.
[0127] This pack arrangement of the roots avoids collision between the articulation pin 5 and, preferably, the third root portion 31 of the thinner blade link 30, thereby providing sufficient precision in positioning the cutting edge 34 relative to the opposing blade 24 for each opening angle of the open / closed degrees of freedom G, and thus extremely high cutting accuracy is achieved. Similarly, this can also be applied to the fourth root portion 41 of the opposing blade link 40 if an opposing blade link 40 is provided.
[0128] Therefore, the distal rotational joint 502 can be given axial rigidity, that is, axial rigidity in the direction of the rotation axis YY.
[0129] According to one embodiment, as schematically shown in Figures 5A and 5B, the acting tendons 71, 72, 73, and 74 of the antagonist tendon pair are adapted to actuate the distal rotary joint 502 of the end effector 9, sliding longitudinally on one or more convex woven surfaces 85, 87 of the connecting link 60 and on one or more convex woven surfaces 84, 86 of the support link 2. In other words, the sliding of the acting tendons on the woven surfaces occurs in the longitudinal extension direction of the tendons themselves 71, 72, 73, and 74. The path of each tendon 71, 72, 73, and 74 is stationary with respect to the convex woven surface on which it slides; that is, each tendon slides longitudinally but not axially, and the longitudinal extension direction of each tendon does not change under any operating conditions. In addition, preferably, the acting tendons 71, 72, 73, 74 of the antagonist tendon pair, adapted to actuate the distal rotation joint 502 of the end effector 9, include tendons 71, 72 of the first antagonist tendon pair terminating on the root 11 of the first tip link 10 and tendons 73, 74 of the second antagonist tendon pair terminating on the root 21 of the second tip link, wherein the tendons 71, 72 of the first antagonist tendon pair wrap around a pulley surface 79 formed by one or more convex wire woven surfaces 79 having generatrixes parallel to the distal rotation axis YY without sliding longitudinally, and the tendons 73, 74 of the second antagonist tendon pair wrap around a pulley surface 80 formed by one or more convex wire woven surfaces 80 having generatrixes parallel to the distal rotation axis YY without sliding longitudinally.
[0130] On the other hand, the convex woven surfaces 85 and 87 of the connecting link 60 and the convex woven surfaces 84 and 86 of the support link 2 do not include guide channels or grooves for holding the tendons within the guide grooves. The geometric relationship between the end seats 15 and 25 of the tendons 71, 72, 73, and 74 and the woven surfaces 79, 80, 84, 85, 86, and 87 over which the acting tendons of the distal rotary joint 502 slide longitudinally or around without sliding is advantageous for the stability of the path of each tendon, even if the body of the link of the end effector 9 does not have guide channels or grooves. Furthermore, the absence of guide channels or grooves for guiding the tendons minimizes sliding friction while minimizing the contact surface between the cross section of each tendon and the convex woven surface on which it slides.
[0131] According to one embodiment, as schematically shown in Figures 5A and 5B, the antagonistic actuating tendons 75, 76, which actuate the proximal rotary joint 509 of the articulated end effector 9, terminate on the support link 2 and do not slide longitudinally relative to the support link 2, that is, they do not slide longitudinally on the one or more wire-woven surfaces 84, 86 of the support link 2, but wrap around it without sliding, while sliding longitudinally on the one or more wire-woven surfaces 85, 87 of the link 60 to move the proximal rotary joint 509. Preferably, the body of the support link 2 integrally includes at least a third termination seat 67 for receiving the actuating tendons 75, 76 of the third antagonistic tendon pair. Thus, the longitudinal extension of the tendons is locally perpendicular to the lines that make up the wire-woven surfaces with which the tendons locally contact.
[0132] The distal rotary joint 502 can induce a cutting motion. The cutting edge 34 of the blade link 30 is positioned to contact the opposing blade surface 24, which rotates integrally with the second tip link 10, while the opening and closing degrees of freedom G move in a mechanical interference contact state to perform the cutting motion. Thus, the axial elasticity for obtaining the cutting motion is at least partially provided by the elasticity of the blade link 30, but the distal rotary joint 502, to which the third root portion 31 of the blade link 30 is articulated, is axially rigid, i.e., no elastic load is applied because relative displacement between the projections 3, 4 on the distal rotation axis YY and the root portions 11, 21, 31 is avoided.
[0133] Preferably, the axial distance Y5 between the first end seat 15 of the root 11 of the first tip link 10 and the surface 84 of the one or more convex wire woven 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 21 of the second tip link 20 and the surface 86 of the one or more convex wire woven 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 wire woven surfaces 84, 86 of the support link 2 and the end seat 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 portion 15 is longitudinally aligned with the convex wire woven surface 84 of the support link 2. In such a case, the actuating tendons 71 and 72 of the first end 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 portion 25 is longitudinally aligned with the convex wire woven surface 86 of the support link 2. In such a case, the actuating tendons 73 and 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 portion 15 of the root portion 11 of link 10 and the surface 84 of the one or more convex wire woven surfaces 84, 86 of support link 2 is equal to the axial distance Y5' between the second end seat portion 25 of the root portion 21 of link 20 and the surface 86 of the one or more convex wire woven surfaces 84, 86 of support link 2.
[0136] Therefore, axial sliding along the joint pin 5 between the roots and between the roots and projections is avoided, and the tendons 71, 72, 73, and 74 of the first or second antagonistic tendon pair slide longitudinally to activate the opening / closing degree of freedom G. That is, the geometric relationship between the wire woven surfaces 84 and 86 of the support link 2 that perform the cutting action and the end seats 15 and 25 of each tendon, which are integrally formed with the root 11 of link 10 or the root 21 of link 20, is maintained. This prevents interference with the relative rotation between the plurality of links around the distal common rotation axis YY.
[0137] In a direction parallel to the axis of rotation, the tendon does not slide against its respective wire-woven surface.
[0138] Therefore, an axially rigid rotary joint 502 of the cutting joint can be formed. A blade is provided having a cutting edge 34 and opposing blade surfaces 24 that rotate integrally with the axially rigid rotary joint 502, and together they can perform a cutting operation during a closing operation with a degree of freedom of opening and closing. Thus, it is possible to avoid providing a Belleville-type elastic element that is attached to the articulation pin 5 or inserted between the projections 3, 4 of the support structure. Furthermore, it is possible to avoid providing an adjustment screw adapted to tighten the base together axially.
[0139] The axially rigid distal rotational joint 502 also allows the cutting edge 34 to be directed by rotating it around the rotation axis of yaw YY, thereby enabling control over the adjustment of the cutting direction.
[0140] Such a distal rotary 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, blade link 30, and second tip link 20 relative to the support structure, and, if present, any orientation of the pitch P degree of freedom of the proximal rotary joint 509, i.e., any movement of the support link 2 and the link 60 of the group formed by the first tip link 10, blade link 30, and second tip link 20 relative to the shaft 7. Preferably, the connecting link 60 to the shaft is firmly 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 projections 3 and 4 of the support structure remains constant for any cutting state, and the projections remain in close, direct contact with the respective surfaces of the first root portion 11 and the second root portion 21.
[0142] Therefore, preferably, the first root portion 11 of the first tip link 10 has a first external contact surface 52, the first projection 3 of the support structure has a first internal contact surface 53, the first external contact surface 52 of the first root portion 11 is in contact with the first internal contact surface 53 of the first projection 3, the second root portion 21 of the second tip link 20 has a second external contact surface 55, the second projection 4 of the support structure has a second internal contact opposing surface 54, the second external contact surface 55 of the second root portion 21 is in contact with the second internal contact opposing surface 54 of the second projection 4.
[0143] For example, according to the embodiment shown in Figure 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 tip link 10, and is in close contact with them. By providing a transverse bridge 33 on the body of the blade link 30 that crosses the rotational approach footprint of the body of the first tip link 10, the cutting edge 34 rotates integrally with the second tip link 20, that is, it comes into contact with the opposing blade surface 24 between the first tip link 10 and the second tip link 20. In other words, the transverse bridge 33 can cross the connection portion 81 of the elongated body of the first tip link 10 and / or the first root portion 11 of the first tip link 10. In such a case, the first internal contact surface 51 of the first root portion 11 contacts the second internal contact surface 56 of the second root portion 21, the first external 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 projection 3 contacts the first contact surface 58 of the third root portion 31. Therefore, according to this embodiment, the blade having the cutting edge 34 remains interposed between the first tip link and the second tip link, and 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 tip link 10.
[0144] For example, according to a preferred embodiment shown in Figure 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 close contact with them to provide a reaction force against the elastic bending of the blade 34 of the blade link 30 during the cutting operation. 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 determines that the third root portion 31 of the blade link 30 does not deform relative to the first root portion 11 and the second root portion 21, because 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 during the elastic deformation in the thickness direction of the body of the blade link 30 performed from interference contact between the cutting edge 34 and the opposing blade surface 24.
[0145] Therefore, preferably, the first root portion 11 of the first tip link 10 has a first internal contact surface 51, the third root portion 31 of the blade link 30 has a first contact surface 58, and the first internal contact surface 51 of the first root portion 11 is 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 has a second internal contact surface 56, and the third root portion 31 of the blade link 30 has a second contact surface 57 or a contact surface facing the opposing blade 57, and the second internal contact surface 56 of the second root portion 21 is in contact with the second contact surface 57 of the third root portion 31.
[0146] In a preferred embodiment, all of the contact surfaces of the base portions 11, 21, 31 and the projections 3, 4 are parallel to each other and preferably all are perpendicular to the common axis of rotation YY. Preferably, in each configuration of the opening and closing degrees of freedom G, all of the contact surfaces of the base portions 11, 21, 31 and the projections 3, 4 remain parallel to each other and are in direct contact with each other.
[0147] According to one embodiment, there is an opposing blade surface 24 made as a separate part from the second tip link 20, and in particular belongs to the opposing blade link 40 having a fourth proximal mounting root 41. The third root 31 of the blade link 30 is axially interposed between the first root 11 of the first tip link 10 and the fourth root 41 of the opposing blade link 40 and is in direct contact with it, and the fourth root 41 of the opposing blade link 40 is axially interposed between the third root 30 of the blade link 30 and the second root 21 of the second tip link 20 and is in direct contact with it, providing a reaction force against the elastic bending of the blade of the blade link 30 during cutting. Accordingly, according to this embodiment, the fourth root portion 41 of the opposing blade link 40 is provided with two opposing contact surfaces 59, 66, and as a result, the first, second, third, and fourth root portions 11, 21, 31, 41 and the projections 3, 4 are provided with contact surfaces 51, 52, 53, 54, 55, 56, 57, 58, 59, 66 that rotate in the axial direction and are all parallel to each other.
[0148] The root portion preferably has a cylindrical shape centered on a common rotation axis YY, and if the third root portion 31 has a substantially smaller thickness than the first root portion 11 and the second root portion 21, the third root portion 31 has a disc-shaped cylindrical shape. Similarly, this can be adapted to a fourth root portion 41 of the opposing blade link 40, if provided.
[0149] The manufacturing of the component by the wire electroerosion process allows for increased tolerances, while still providing a minimal local microclearance of about one-tenth of a millimeter between at least some of the contact surfaces of the root and / or projection in the direction of the common rotation axis YY, thereby ensuring direct contact. At the same time, relative rotation around the common rotation axis YY is possible during the operation of the open / closed degrees of freedom G and / or yaw Y degrees of freedom. The articulated pin 5 can interfere with at least one of the root and / or projection, i.e., can rotate integrally with at least one of the root and / or projection.
[0150] In particular, because the support structure having two protrusions 3 and 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, a minimum microclearance is inevitably included in the axial direction, i.e., in the direction of the common rotation axis YY between the respective contact surfaces. According to one embodiment, the overall microclearance is in the range between 1 / 20 and 1 / 5 of the thickness of the third root portion 31 of the blade link 30, and is divided, i.e., locally distributed between the contact surfaces of the protrusions 3 and 4 and the root portions of the respective links, where the contact surfaces of the respective protrusions 3 and 4 of the first and second tip links 10, and the contact surfaces of the first and second root portions 11 and 21, respectively, are made by wire electrolytic erosion (WEDM).
[0151] Therefore, the expression “in direct contact” is also intended to indicate embodiments in which, in any case, minimal microclearance is provided between the projections of the support structure and the contact surfaces of the roots of each link, not just some of them, but all of them. During the cutting operation, especially at relatively large opening angles of the opening and closing degrees of freedom G (e.g., an angle of about 20°-30° between the gripping surfaces 13 and 23), the mechanical interference contact between the cutting edge 34 of the blade link 30 and the opposing blade surface 24 can thus generate minimal minute displacements of about one-hundredth of a millimeter along the articulating pin 5 of the third root. The same applies to the fourth root portion 41, if present.
[0152] For example, as is evident from the analysis conducted by the present inventors, according to one embodiment, the thickness of the third root portion 31 of the blade link 30 is approximately 0.2 mm, the overall microclearance in the direction of the common rotation axis YY in the operating state, locally distributed between the contact surface of the projection and the root portion of each link, is approximately 0.02 mm overall, and when in the operating state, 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 is approximately 0.01 mm, which is substantially equal to 1 / 20 of the thickness of the third root portion 31 of the blade link 30.
[0153] The support structure having two protrusions 3 and 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 that impose the minimum clearance in the direction of the common rotation axis YY, as described above. This makes it possible to operate the degree of freedom of opening and closing rotation G in a precise and controlled manner in both the opening and closing directions, and to perform gripping and / or cutting operations simultaneously.
[0154] The articulated pin 5 can be made in the form of two opposing, aligned cantilever legs integrated with the first root portion 11 of the first end link 10, or in the form of two opposing, aligned cantilever legs integrated with the second root portion 21 of the second end link 20. Alternatively, the articulated pin 5 can be made of two parts, the first part being a single part with two opposing, aligned cantilever legs comprising the first root portion 11 of the first end link 10, and the second part being a single part with two opposing, aligned cantilever legs comprising the second root portion 21 of the second end link 20, wherein the first and second parts of the articulated pin 5 are aligned along a common axis of rotation YY.
[0155] In a preferred embodiment, the first root portion 11 of the first tip link 10 is provided with a first through hole 16, the second root portion 21 of the second tip link 20 is provided with a second through hole 26, and the third root portion 31 of the blade link 30 is provided with a third through hole 36, and 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 are aligned on the axis with the common rotation axis YY. In one embodiment, the articulated pin 5 is received inside the first, second, and third through holes 16, 26, and 36. In this case, the articulation pin 5 can be manufactured as a single cantilever leg having one of the projections 3, 4 of the support structure, or the articulation pin 5 can be manufactured as two parts in the form of two opposing, aligned cantilever legs, each of the two parts being a single part having one of the projections 3, 4 of the support structure. However, according to a preferred embodiment, the articulation pin 5 is a separate part with respect to the roots 11, 21, 31 and also with respect to the projections 3, 4. According to one embodiment, each of the two projections 3, 4 is aligned on the axis with the common rotation axis YY and has a through hole of projection 165 aligned with each of the first, second, and third through holes 16, 26, 26 of the first, second, and third root portions 11, 21, 31, and all of them.
[0156] According to one embodiment, 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 are all circular through holes, coaxial with the common rotation axis YY, and receive a single articulated pin 5 that extends in the direction of the common rotation axis YY from the first projection 3 of the support structure to the second projection 4 of the support structure. According to one embodiment, 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 all have substantially the same diameter and receive the articulated pin 5 in direct contact with the entire circumferential extension of their respective hole edges 16.1, 26.1, and 36.1.
[0157] By providing the circular third through-hole 36 of the third root portion 31 of the blade link 30 in direct and close contact with the articulating pin 5 along the entire circumferential extension of its edge 36.1, it becomes possible to provide a reaction force to 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 mechanical interference contact between the cutting edge 34 (and preferably the blade surface 35 as well) of the blade link 30 and the opposing blade surface 24 that rotates integrally with the second tip link 20. Thus, a direct frictional force in the opening direction is generated on the cutting edge 34 (and preferably the blade surface 35 as well) of the body of the blade link 30 in contact with the opposing blade surface 24, which is balanced by the reaction force to the friction of the cutting action exchanged at the portion of mutual contact between the edge 36.1 of the third through-hole 36 of the third root portion 31 of the blade link 30 and the articulating pin 5. The frictional reaction force of the cutting operation is preferably directed substantially radially with respect to the common axis of rotation YY. The frictional reaction force of the cutting operation preferably affects the arcuate surface 38 of 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, if there is an opposing blade surface 24 belonging to the opposing blade link 40, which is made of a separate part from the second tip link 20 and in particular has a fourth proximal mounting root 41, the fourth root 41 of the opposing blade link 40 is provided with a fourth through hole 43, and the first through hole 16 of the first root 11, the second through hole 26 of the second root 21, the third through hole 36 of the third root 31, and the fourth through hole 43 of the fourth root 41 are all circular through holes, coaxial with the common rotation axis YY, and receive a single articulated pin 5 that extends in the direction of the common rotation axis YY from the first projection 3 of the support structure to the second projection 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 that 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 the arcuate surface of the hole edge, which is the thickness of the hole edge.
[0159] When at least a portion, or even all, of the through-holes at the roots are created by wire electrolytic erosion (WEDM), radial cut channels 19, 29, 39, and 49 are provided at each root between the hole edge and the outer edge of each root, as an effect of the continuous cut path of the cut wire used to create the through-holes by wire electrolytic erosion. 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 at the root 31 of the blade link 30 is radially offset from the cut channel 29 at the second root 21 of the second tip link 20 and the cut channel 49 at the fourth root 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-holes 165 of each of the two projections 3 and 4 are circular through-holes coaxial with the common rotation axis YY. When the projections 3 and 4 of the support structure are made by wire electroerosion, at least one radial channel can be provided in each projection between the hole edge and the outer edge.
[0161] According to one embodiment, the opposing blade surface 24 can be configured to be inclined in a direction that crosses the longitudinal extension of the body of the second tip link 20, preferably perpendicular to the longitudinal extension of the body of the second tip link 20, crosses the common rotation axis YY, and preferably perpendicular to the common rotation axis YY. In other words, the opposing blade surface 24 can be configured to be inclined in a direction that connects the back side D2 with the gripping side P2 of the second tip link 20, and preferably protrudes 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, the opposing blade surface 24 is a curved surface. As a result, the opposing blade surface 24 protrudes due to its arch shape. The concave surface of the opposing blade surface 24 preferably faces axially and inward, that is, parallel to the common rotation axis YY and facing the rotation footprint of the blade link 30.
[0163] The opposing blade surface 24 can function as a wedge that appropriately bends the cutting edge 34 and blade link 30, thereby exerting 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 its non-deformable state, i.e., when on a defined lying surface. Elastic bending of the blade link 30 tends to return the blade link 30 to the non-deformable planar configuration. Thus, the blade surface 35 facing axially inward is parallel to the second contact surface 57 of the third root portion 31 of the blade link 30, and preferably can be seamlessly aligned, for example. In other words, according to one embodiment, the defined 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 its non-deformable 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 the 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 and rigid shaft and the cutting edge 34 is not in contact with a projection on the opposing blade surface 24.
[0166] According to one embodiment, a resistance engagement portion is provided located distal to the common rotation axis YY in order to rotate the blade link 30 integrally with the first tip link 10. The resistance engagement portion 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 preferably is formed near or at the distal end of the cutting edge 34 of the blade link 30. The resistance engagement portion can be obtained by engagement between the blade link 30 and the first tip link 10.
[0167] According to one embodiment, the first tip link 10 comprises at least one resistance surface 17.1, 17.2 for pulling the blade link 30 into a ration, preferably comprising an open resistance surface 17.2 and a closed resistance surface 17.1. According to one embodiment, the at least one resistance surface 17.1, 17.2 of the first tip link 10 defines a resistance seat 17 that receives the resistance portion of the blade link 30, causing the blade link 30 and the first tip link 10 to rotate together. In this case, the at least one resistance surface 17.1, 17.2 of the first tip link 10 comprises two opposing resistance surfaces 17.1, 17.2 that interface with two opposing resistance surfaces 37.1, 37.2 of the blade link 30, causing the blade link 30 to rotate in both the opening and closing directions of the opening and closing degrees of freedom G. In such cases, the drag portion of the blade link 30 can be positioned at the third root portion 31 to achieve more advantageous mechanical transmission; however, to ensure accurate drag, it is preferable that the drag portion of the blade link 30 be positioned away from the third root portion 31 of the blade link 30. The open drag-facing surface 37.2 and the closed drag-facing surface 37.1 of the blade link 30 can be positioned on a single portion, for example, as opposing surfaces of a single projection that may coincide with the distal end 32 of the blade link 30.
[0168] According to one embodiment, the resistance portion of the blade link 30 coincides with the distal end 32 of the blade link 30, and the resistance seat portion 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 the surface that can act as a contact portion for blade deformation. In such a case, the resistance seat portion 17 has an axial extension to receive the distal end 32 of the blade link 30 and thus, together with the deformation seat portion 14, receives the deformation of the blade link 30 during the cutting operation. The distal end 32 of the blade link 30 may include the distal portion of the cutting edge 34, in which case the distal portion of the cutting edge 34 acts as a resistance-facing surface in the opening direction 37.2 cooperating with the respective open resistance surfaces 17.2 of the first blade link 10. According to one embodiment, the resistance teeth 17.0 extend proximal to the first gripping surface 13, that is, toward the common rotation axis YY, open proximal to the first gripping surface 13 that extends axially, forming an undercut seat portion 17 that receives the distal end 32 of the blade link 30.
[0169] In an embodiment in which the resistance portion of the blade link 30 coincides with the distal end 32 of the blade link 30, the distal end 32 of the blade link 30 is constrained to rotate together with the first tip link 10 and slides freely in the axial direction relative to the tip link 10 within the resistance seat 17 during elastic bending deformation during cutting.
[0170] The open drag-facing surface 37.2 and closed drag-facing surface 37.1 of the blade link 30 can be located at different distances from the common rotation axis YY, for example, on different protrusions of the blade link 30, as shown in Figure 28A. Referring particularly to Figures 28A, 28B, 28C, and 29A, the third root portion 31 of the blade link 30 may include a radial drag ear 37 folded onto the first root portion 11 of the first tip link 10, the drag ear 37 including the open drag-facing surface 37.2 which is in drag-contact with the open drag-facing surface 17.2 located on a portion 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, made of separate parts, rotate integrally with each other in a releasable manner, and the releasing can be done preferably only by disassembling the articulated end effector 9.
[0172] According to alternative embodiments, which may not necessarily be combined with all embodiments described herein, as shown in Figure 18, for example, the blade 30 is formed integrally with the first tip link 10, thereby defining a blade 30 having a cutting edge 34 that extends longitudinally and cantilever-like from the first root portion 11 of the first tip link 10. In particular, in this alternative embodiment, 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 the cutting edge 34 cantilever-like from the root portion of the first tip link 10 adjacent to the connection portion 81 of the first tip link 10. Thus, in this alternative embodiment, the first internal contact surface 51 of the first root portion 11 of the first tip link 10 is in direct contact with the second internal 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 can be aligned with the first internal contact surface 51. This alternative configuration can be combined with any embodiment of the opposing blade surface 24 described herein, for example, the opposing blade surface 24 may be manufactured integrally with the second tip link 20 or as a separate component providing the opposing blade link 40.
[0173] According to one embodiment, the second tip link 20 is provided with a screw-fastened wall 28 facing a common rotation axis YY, the screw-fastened wall defining a screw-fastened recess 28.1 for receiving the suture wire 6 and keeping the suture wire 6 in contact with the cutting edge 34 of the blade of the blade link 30 during cutting closure. As an effect of the closure operation, the suture wire 6 is prevented from sliding distally beyond the distal end 32 of the blade during the cutting operation.
[0174] The screw-fastening wall 28 and screw-fastening recess 28.1 preferably face the gripping side P2 of the second end link 20. For example, the screw-fastening wall 28 is an arch-shaped wall having a concave surface that defines 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 provided in the body of the second end link 20, in which case the screw-fastening wall 28 is the wall defining the notch. The recess 28.1 can be made in the form of an undercut wall provided in a protruding portion of the body of the second end link 20, in which case the screw-fastening wall 28 is the undercut wall of the protruding portion facing the common rotation axis YY.
[0175] According to one embodiment, the screw-fastened wall 28 defines the opposing blade surface 24 from the gripping side P2 of the second tip link 20 at its axial inner edge. If the opposing blade surface 24 is made of a separate part from the second tip link 20, the screw-fastened wall 28 and the recess 28.1 can be formed in the body of the opposing blade link 40.
[0176] As described above, according to one embodiment, the second tip link 20 integrally comprises the opposing blade surface 24. Alternatively, as described above, the opposing blade link 40 is provided as a separate part from the second tip link 20 and can rotate integrally with it, and the opposing blade link 40 comprises the opposing blade surface 24 and a fourth proximal mounting root portion 41 articulated in the common rotation axis YY. According to one embodiment, the second tip link 20 comprises an axial recess 45 that forms a housing seat for the opposing blade link 40. The axial recess 45 is preferably defined axially by an axially inward surface 48 of the second tip link 20.
[0177] According to a preferred embodiment, the opposing blade link 40 is elastically deformable by bending. As a result, when the cutting edge 34 of the blade link 30 mechanically interferes with the opposing blade surface 24 of the opposing blade link 40 to perform a cutting operation, the body of the opposing blade link 40 also bends elastically in the axial direction.
[0178] The opposing blade link 40 is preferably made from an elastic sheet or strip and is pre-curved to form a curved and protruding opposing blade surface 24 having a concave surface facing axially inward in order to elastically bend the blade link 30 during the cutting operation. By providing an opposing blade link 40 having a curved and protruding opposing blade surface 24 that can be elastically deformed by bending, it becomes possible to obtain an elastic reaction force between the axially inward 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 opposing blade link 40 has a stationary surface 46 that is axially oriented opposite the opposing blade surface 24 and in contact with the surface 48 of the axial recess 45 of the second tip link 20 that faces axially inward, so that the opposing blade link 40 can provide elastic action to the cutting edge 34 of the blade link 30 for the purpose of elastically bending the blade link 30 during the cutting operation.
[0179] The opposing blade link 40 may have at least some of the features and characteristics described above with reference to the blade link 30, but may also have all of them. The thickness of the opposing blade link 40 may be substantially the same as, or equivalent to, the thickness of the blade link 30, as described above. According to one embodiment, the opposing blade link 40 preferably includes an opposing blade cutting edge 44 positioned 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 mounting root 41 of the opposing blade link 40 may have at least some of the features and characteristics described above with reference to the third root 31 of the blade link 30, but may also have all of them. In particular, according to a preferred embodiment, the fourth root 41 of the opposing blade link 40 defines a fourth through hole 46 for receiving the articulation pin 5. The fourth root 41 may include a radial cut channel 49 offset from the radial cut channel 39 of the blade link 30.
[0180] According to one embodiment, in order to rotate the opposing blade link 40 and the second tip link 20 together, a resistance engagement portion is provided along the longitudinal extension of the opposing blade surface 24, or distal to it. Preferably, the resistance engagement portion 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 includes a resistance seat 47 having an open resistance surface 27.2 and an opposite closed resistance surface 27.1 in order to rotate the blade holder link 40 integrally. The resistance seat 47 can be positioned distally within a resistance seat formed as an undercut with respect to the second gripping surface 23 of the second tip link 20 in order to receive the distal end 42 of the opposing blade link 40. According to one embodiment, the distal end 42 of the opposing blade link includes an open resistance surface 47.2 that makes resistance contact with the open resistance surface 27.2 of the second tip link 20 and an opposite closed resistance surface 47.1 that makes resistance contact with the closed resistance surface 27.1.
[0182] For example, according to the embodiment shown in Figure 29B, the opposing blade link 40 includes a radial drag ear 47.0 folded into the second root portion 21 of the second tip link 20, and the drag ear 47.0 of the opposing blade link 40 includes an open drag surface 47.2 that is in drag contact with an open drag surface 27.2 located 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 includes a closed drag surface 47.1 located close to the distal end 42 of the opposing blade link 40 that is in drag contact with a closed drag surface 27.1 of the second tip link 20.
[0183] According to the embodiment shown in Figure 27, for example, the opposing blade cutting edge 44 can have a concave shape with respect to the opening / closing direction.
[0184] According to a general embodiment, a rotary joint 502 of the joint is provided according to any one of the embodiments described above.
[0185] The rotary joint 502 of the cutting joint is an axially rigid coupling.
[0186] According to a general embodiment, a robotic surgical system 101 is provided comprising at least one needle holder / cutter type surgical instrument 1 according to any one of the embodiments described above. Thus, the robotic surgical system 101 can perform surgical or microsurgical procedures of anastomosis and / or suturing in which the needle holder / cutter type surgical instrument 1 can manipulate a surgical needle and cut a suture wire at the same time.
[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 embodiments described above, and the other surgical instrument may be a needle driver type surgical instrument or an expander type surgical instrument, but according to one embodiment, both surgical instruments are needle holder / cutter type surgical instruments 1.
[0188] The robotic surgical system 101 preferably comprises at least one robotic manipulator 63, and at least one needle holder / cutter type surgical instrument 1 is operably connected to the at least one robotic manipulator 63. For example, a sterile surgical barrier (not shown), such as a sterile surgical cloth, is interposed between the at least one robotic manipulator 63 and the rear end portion 61 of the at least one needle holder / cutter type surgical instrument 1. The robotic manipulator 63 applies stress to the operating tendons of pitch P, yaw Y, and gripping degrees of freedom G. That is, it may comprise an electric actuator for gripping and cutting the surgical instrument 1 and an electric actuator for rotating the surgical instrument 1 around a shaft 7 that defines the rolling degrees of freedom. The robotic surgical system 101 may comprise, for example, a support unit 69 (cart or tower) having wheels or other grounding units, and a manually movable, i.e., passively articulated positioning arm 70 extending between the support unit 69 and the at least one robotic manipulator 63. According to one embodiment, the robotic surgical system 101 comprises at least one master console 68 for controlling at least one needle holder / cutter type surgical instrument 1, preferably each robotic manipulator 62, in accordance with a master-slave structure, and preferably the robotic surgical system 101 further comprises a control unit operably connected to the master console 68 and the robotic manipulator 63 to determine the tracking of the needle holder / cutter type surgical instrument to 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 unconstrained, i.e., mechanically disconnected from the ground, and, for example, an optical and / or magnetic tracking system.
[0189] Thanks to the above features provided separately or in combination in predetermined embodiments and predetermined operating modes, the aforementioned needs can be met even in the event of inconsistencies, and the aforementioned advantages can be included, in particular, the following advantages:
[0190] - The degree of freedom of opening and closing allows for the gripping action of a surgical needle at a portion of the end effector on the gripping surfaces of the first and second tip links, and the cutting action of a suture wire at the proximal portion of the gripping surfaces of the first and second tip links.
[0191] - Compared to known solutions, this allows for extreme miniaturization of the articulated end effector of needle holder / cutter-type surgical instruments.
[0192] - By providing elastic washers and adjustment screws, and by allowing the bases of the links to be stacked between projections of the support structure while avoiding tapping or threading at the mounting base level, it is possible to enable extreme miniaturization of the articulated end effector.
[0193] - In particular, joint pin 5 is not threaded.
[0194] - The surface of the hole edge of the through hole at the base of each link is not tapped, i.e., no internal threads are cut there, and the inner surface of the through hole of the projection that penetrates the projection of the support structure is also not tapped, i.e., no internal threads are cut there.
[0195] - It lacks elements such as Belleville washers attached to the joint pins.
[0196] - On the other hand, all the elasticity necessary for the cutting motion 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), creating a very compact articulated end effector and enabling precise cutting motion.
[0197] - In particular, at relatively high degrees of freedom angles for opening and closing the blade, the blade is free, i.e., not subjected to elastic stress, and preferably, in such a configuration, the blade is straight. In the open configuration of the opening and closing degrees of freedom, the blade can overlap with the rotational footprint of the protruding opposing blade, i.e., it can overlap with the rotational footprint of the second tip link (as well as the opposing blade link, if present), and in the open configuration of the opening and closing degrees of freedom, the blade is spaced apart from the connection of the first tip link, in particular spaced apart from the axially inward surface 18 of the first tip link, thereby defining the deformable seat 14 for the blade.
[0198] -As the opening angle of the degree of freedom of opening and closing closes, the blade is elastically bent and elastically pushes against the opposing blade 24. In a closed degree of freedom configuration in which the blade is opened and closed by bringing the blade into contact with the connecting portion of the first tip link and the second tip link, the blade can be interposed between the connecting portion of the first tip link and the second tip link (or, if present, it can be in contact with the opposing blade link, and then interposed between the blade and the body of the second tip link).
[0199] - Because the elasticity required for the cutting motion is concentrated on the distal side of the blade link body relative to the base, a deformation seat can be provided that can withstand relatively high axial bending of the blade.
[0200] - The roots stacked within the pack between the protrusions provide a reaction force against the elastic bending deformation of the blade, avoiding axial sliding on the pin, and thus enabling accurate and effective cutting action of the cutting edge 34 even at high open angles, i.e., the cutting edge can push against the opposing blade even on the proximal side at the position of the root adjacent to the articulating pin.
[0201] - While the first and second tip links are directly actuated by the actuating tendon, the blade links and opposing blade links, if present, are subjected to rotational resistance by the first and second tip links.
[0202] -By providing such a third root portion 31 of the blade link 30, the blade link 30 can be firmly fixed to the common rotation axis YY when in operation, for example, during a cutting operation, and by providing such a resistance seat portion 17 for rotating the blade link 30 together with the first tip link 10 positioned close to the distal end 32 of the blade link (the same applies to the opposing blade link 40 if present), the blade link 30 can be firmly fixed while receiving axial deformation of the distal end 32 of the blade link, enabling extreme miniaturization of the articulated end effector without causing positioning and cutting inaccuracies, while at the same time providing a robust and reliable solution that avoids the risk of blade link loss, i.e., detachment of the blade link when in operation.
[0203] -By providing through holes in the roots of all coaxial parts that contact and receive the articulating pins, unintended relative rotation between the roots can be avoided, providing certainty in the positioning of the cutting edge 34 of the blade link 30 relative to the opposing blade surface 24 and gripping surfaces 13, 23 when in operation, and thus enabling extreme miniaturization of the articulated end effector, as small rotational movements at the root level, i.e., next to the common axis of rotation, result in relatively large cutting inaccuracies.
[0204] Furthermore, the holes 36 in the blade links, with their proximal edges pressing against the pins, exert a counterforce against the friction between the blade and the opposing blade during the cutting operation, which helps to achieve precise cutting.
[0205] - The cutting edges of the blade links can be straight, i.e., without concave surfaces, which facilitates continuous production and allows for starting with, for example, a single band or strip.
[0206] - If present, the integrated rotation of the blade link with a free end and the opposing blade link allows the cutting motion to be performed in various orientations of yaw degrees of freedom, thus replicating the orientation of the surgeon's hand, and thus possesses remarkable intuitiveness, as well as being easily observed, for example, under a microscope.
[0207] - By moving away from the articulating pin and providing contact for the distal end of the closing stroke relative to the articulating pin, high-precision closing is possible, and by not occupying the proximal region of the support fork, extreme miniaturization is promoted.
[0208] - The end seat of the tendon and wire-woven pulley surface, which is made as a single piece with each link, is advantageous for miniaturization, helps to keep the number of parts low, and helps to keep the articulated end effector compact.
[0209] - In the case of needle driver / scissors-type surgical instruments, by interposing the blade between the tip links, the blade can be concealed by the closed end effector, allowing the suture wire to be wrapped around the tip links without being damaged, for example.
[0210] - Providing a single drag engagement point in the rotation between the two links allows for minimizing the drag clearance and promotes miniaturization.
[0211] - The rotary joint 502 defining the common rotation axis YY can be a hinge.
[0212] It should be fully understood that any combination of features, structures, or functions disclosed in one or more of the attached claims forms an integral part of this specification.
[0213] To meet certain incidental needs, a person skilled in the art can make several modifications and adaptations to the embodiments described above, without departing from the scope of the appended claims, and replace elements with other functionally equivalent elements. [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. Sutures or suture wires 7 Surgical instrument shafts 8. Distal shaft end 9. Articulated end effector, or articulated terminal 10 First tip link or blade holder link 11 The first proximal mounting base of the first tip link, or the mounting base of the first tip link 12 The first distal free end of the first tip link, or the free end of the first tip link 13. The first gripping surface of the first tip link, or the gripping surface of the first tip link 14. Deformable seat for the first tip link blade 15 First end seat of the first link, or end seat of the first link 16 First through hole in the first root of the first tip link, or hole in the root of the first tip link 16.1 Hole margin of the first hole at the first root 17. Resistance seat of the first tip link 17.0 Resistance teeth of the first leading link 17.1 Closure drag surface of the first leading link 17.2 Open drag surface of the first leading link 18 First tip link surface facing inward in the axial direction 19 Cut channel at the first root of the first tip link 20. Second leading link or reaction link 21 The second proximal mounting base of the second tip link, or the mounting base of the second tip link 22 The second distal free end of the second tip link, or the free end of the second tip link 23 The second gripping surface of the second end link, or the gripping surface of the second end link 24 Opposing blade surface 25 Second end seat of the second link, or second link end seat 26 The second through hole in the second root of the second tip link, or the hole in the root of the second tip link 26.1 Hole margin of the second hole at the second root 28 Screw-fastened wall 28.1 Screw-fastened wall recess 29 Cut channel at the second root of the second tip link 30 blade links or blades 31. Third proximal mounting root of the blade link, or blade link root 32 Tip blade link end 33. Transverse Blade Link Bridge 34 Blade Link Cutting Edge 35 Blade surface facing the axially inward side of the blade link 36. Third through hole in the third root of the blade link, or hole in the root of the blade link. 36.1 Hole margin of the third hole at the third root 37. Drag year of the third blade link 37.1 Closing drag-facing surface of blade link 37.2 Blade link open drag opposing surface 38. Arcarous surface of the hole edge at the third root of the blade link 39 Cut channel at the third root of the blade link 40 Opposing Blade Link 41 The fourth proximal mounting 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 the fourth root of opposing blade link 43.1 Hole edge of the through hole at the base of the opposing blade link 44 Opposing blade cutting edge 45 Axial recess of opposing blade link 46 Opposing blade link support surface 47. Resistance seat of the second tip link 47.0 Drag year of opposed blade link 47.1 Closing drag force on opposing blade link 47.2 Open drag surface of opposing blade link 48 Second tip link surface facing inward in the axial direction 49 Cut channels of opposing blade links 50 Master control devices 51 The first internal contact surface of the first root of the first tip link, or the internal contact surface of the root of the first tip link 52 The first external contact surface of the first root of the first tip link, or the external contact surface of the root of the first tip link 53 The first internal contact surface of the first projection of the support link, or the internal contact surface of the first projection of the support link 54 The second internal contact surface of the second projection of the support link, or the internal contact surface of the second projection of the support link 55 The second external contact surface of the second root of the second tip link, or the external contact surface of the root of the second tip link 56 The second internal contact surface of the second root of the second tip link, or the internal contact surface of the root of the second tip link 57 The contact surface of the third root of the blade link facing the opposing blade, or the second contact surface of the third root of the blade link 58 First contact surface of the third root of the blade link 59 Contact surface of the fourth root of the opposing blade link 60 End effector link or connecting link for connecting to a shaft 60.1 First projection of the connecting link 60.2 Second protrusion of the connecting link 61. Posterior end portion or proximal interface portion of a surgical instrument. 62 Proximal shaft end 63 Robot Manipulator 64 Shaft fixing device 66 Contact surface of the fourth root of the opposing blade link facing the blade 67 Third terminal seat of the support link 68 Master Console 69 Support unit, cart, or tower for a robotic system 70. Articulated positioning arm of a robotic system 71. Opening operation tendon of the first leading link 72. Closure action tendon of the first leading link 73. Release operation tendon of the second leading link 74. Closure action tendon of the second leading link 75 Actuating tendon of support link 76 Operating Opposite Tendon of Support Link 77 Cantilever drag leg of the first terminal seat of the first tip link 78 Cantilever drag leg of the second terminal seat of the second tip link 79 Line-woven pulley surface of the first leading link 80 Wire-woven pulley surface of the second leading link 81 First tip link connection between the first base and the first gripping surface 82 Second tip link connection between the first base and the first gripping surface 70 Tendon Termination 84 Convex linear woven surface of support link 85 Convex wire woven surface of connecting link 86 Opposing convex linear woven surfaces of the support link 87 Opposing convex wire woven sliding surfaces of connecting links 101 Robotic Surgical System 165 Projection hole 502 Rotary joint of cutting joint, or distal rotary joint 509 Proximal Rotational Joint XX Longitudinal shaft axis YY common axis of rotation, or common distal axis of rotation or common yaw axis of rotation PP common proximal rotation axis, or common pitch rotation axis Y-Yaw degrees of freedom Pitch degree of freedom G Open / close direction, gripping degree of freedom R (Roll) degrees of freedom At least one contact point between the POC blade and the opposing blade D1 The back of the first leading link P1 Gripping side of the first tip link D2 The back of the second leading link P2 Gripping side of the second tip link
Claims
1. A needle holder / cutter type surgical instrument (1) for a robotic surgical system (101) equipped with an articulated end effector (9), wherein the articulated end effector (9) is A support structure including two protrusions (3, 4), A first tip link (10) has an elongated body integrally comprising a first proximal attachment base (11), a first distal free end (12), and a first gripping surface (13) between the first proximal attachment base (11) and the first distal free end (12), A second tip link (20) has an elongated body integrally comprising a second proximal attachment base (21), a second distal free end (22), and a second gripping surface (23) between the second proximal attachment base (21) and the second distal free end (22), A blade link (30) integrally comprising a third proximal mounting base (31), an elastically deformable bending body, and a cutting edge (34), Equipped with, The support structure, the first tip link (10), the second tip link (20), and the blade link (30) are separate components articulated with each other by 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 mounting root (11) of the first tip link (10), the second proximal mounting root (21) of the second tip link (20), and the third proximal mounting root (31) of the blade link (30) are adjacent to each other in the axial direction. The first proximal mounting root (11) of the first tip link (10), the second proximal mounting root (21) of the second tip link (20), and the third proximal mounting root (31) of the blade link (30) are articulated with respect to the projections (3, 4) of the support structure around the common axis of rotation (Y-Y), defining the directional degree of freedom (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 mounting root (11) of the first tip link (10) and the second proximal mounting root (21) of the second tip link (21) are articulated with each other around the common axis of rotation (Y-Y), defining the relative opening / closing degrees of freedom (G) between the second tip link (20) and the group formed by the first tip link (10) and the blade link (30). An opposing blade surface (24) is provided that rotates integrally with the second tip link (20), The opposing blade surface (24) abuts against the cutting edge (34) of the blade link (30) and is fitted to elastically bend the blade link (30) in the axial direction, thereby causing the cutting edge (34) of the blade link (30) and the opposing blade surface (24) to reach a state of mechanical interference contact and perform a cutting operation. The group formed by the first proximal mounting root (11) of the first tip link (10), the second proximal mounting root (21) of the second tip link (20), and the third proximal mounting root (31) of the blade link (30) is interposed overall between the two projections (3, 4) of the support structure and is in close contact with the projections (3, 4), The third proximal mounting base (31) of the blade link (30) is interposed between the first proximal mounting base (11) of the first tip link (10) and the second proximal mounting base (21) of the second tip link (20), and is in direct close contact with the first proximal mounting base (11) and the second proximal mounting base (21), providing a reaction force against the elastic bending of the blade (34) of the blade link (30) during cutting. Needle holder / cutter-type surgical instrument (1).
2. The first proximal mounting base portion (11) of the first tip link (10) is provided with a first internal contact surface (51), The third proximal mounting root portion (31) of the blade link (30) is provided with a first contact surface (58), and the first internal contact surface 51 of the first proximal mounting root portion (11) is in contact with the first contact surface (58) of the third proximal mounting root portion (31). The second proximal mounting base (21) of the second tip link (20) is provided with a second internal contact surface (56), and the third proximal mounting base (31) of the blade link (30) is provided with a second contact surface (57), and the second internal contact surface (56) of the second proximal mounting base (21) is in contact with the second contact surface (57) of the third proximal mounting base (31). The first proximal mounting base (11) of the first tip link (10) is provided with a first external contact surface (52), the first projection (3) of the support structure is provided with a first internal contact surface (53), and the first external contact surface (52) of the first proximal mounting base (11) is in contact with the first internal contact surface (53) of the first projection (3). The second proximal mounting base (21) of the second tip link (20) has a second external contact surface (55), the second projection (4) of the support structure has a second internal contact opposing surface (54), and the second external contact surface (55) of the second proximal mounting base (21) is in contact with the second internal contact opposing surface (54) of the second projection (4). The needle holder / cutter-type surgical instrument (1) according to claim 1.
3. The distance between the projections (3, 4) of the support structure is kept constant in any cutting state, and the projections (3, 4) maintain a state of direct and close contact with the respective surfaces of the first proximal mounting base (11) and the second proximal mounting base (21). A needle holder / cutter-type surgical instrument (1) according to claim 1 or 2.
4. The first proximal mounting base portion (11), the second proximal mounting base portion (21), the third proximal mounting base portion (31), and the protrusions (3, 4) are, All are parallel to each other and include contact surfaces (51, 52, 53, 54, 55, 56, 57, 58) that face in the axial direction, In each of the open / closed degrees of freedom (G) configurations, all contact surfaces of the first proximal mounting base (11), the second proximal mounting base (21), the third proximal mounting base (31), and the projections (3, 4) are parallel to each other and in direct contact with each other. The needle holder / cutter-type surgical instrument (1) according to claim 1.
5. The first proximal mounting base (11) of the first tip link (10) is provided with a first through hole (16), the second proximal mounting base (21) of the second tip link (20) is provided with a second through hole (26), and the third proximal mounting base (31) of the blade link (30) is provided with a third through hole (36), The first through hole (16) of the first proximal mounting base, the second through hole (26) of the second proximal mounting base, and the third through hole (36) of the third proximal mounting base are all circular through holes, coaxial with the common rotation axis (Y-Y), and receive a single articulated pin (5) that extends axially from the first projection (3) of the support structure to the second projection (4) of the support structure. The third through hole (36) of the third proximal mounting base (31) of the blade link (30) has a hole edge, and the hole edge is in direct contact with the articulating pin (5) over the entire extension of the hole edge. The needle holder / cutter-type surgical instrument (1) according to claim 1.
6. The opposing blade surface (24), which rotates integrally with the second tip link (20), protrudes axially to bend the blade link (30), The opposing blade surface (24) is a curved protruding surface having a concave surface facing inward in the axial direction. The needle holder / cutter-type surgical instrument (1) according to claim 1.
7. The body of the blade link (30) is substantially planar in its non-deformable form and lies on a definable lying surface, The blade surface (35) of the blade link (30) facing in the axial direction is parallel to and aligned with the contact surface (57) of the third proximal mounting root (31) of the blade link (30), which is in direct close contact with the second proximal mounting root (21) of the second tip link (20), and / or The cut edge (34) is straight when undeformed and extends as a linear extension of the second contact surface (57) of the third proximal mounting root (31) of the blade link (30), and / or The cut edge (34) extends parallel to the definable plane of the blade link (30), The needle holder / cutter-type surgical instrument (1) according to claim 1.
8. The first tip link (10) comprises an axially extending axial deformation seat (14) for receiving the elastic bending of the blade of the blade link (30) during the cutting operation. The needle holder / cutter-type surgical instrument (1) according to claim 1.
9. A needle holder / cutter type surgical instrument (1) for a robotic surgical system (101) comprising an articulated end effector (9), wherein the articulated end effector (9) is A support structure including two protrusions (3, 4), A first tip link (10) has an elongated body integrally comprising a first proximal attachment base (11), a first distal free end (12), and a first gripping surface (13) between the first proximal attachment base (11) and the first distal free end (12), A second tip link (20) has an elongated body integrally comprising a second proximal attachment base (21), a second distal free end (22), and a second gripping surface (23) between the second proximal attachment base (21) and the second distal free end (22), A blade link (30) integrally comprising a third proximal mounting base (31), an elastically deformable bending body, and a cutting edge (34), Equipped with, The support structure, the first tip link (10), the second tip link (20), and the blade link (30) are separate components articulated with each other by 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 mounting root (11) of the first tip link (10), the second proximal mounting root (21) of the second tip link (20), and the third proximal mounting root (31) of the blade link (30) are adjacent to each other in the axial direction. The first proximal mounting root (11) of the first tip link (10), the second proximal mounting root (21) of the second tip link (20), and the third proximal mounting root (31) of the blade link (30) are articulated with respect to the projections (3, 4) of the support structure around the common axis of rotation (Y-Y), defining the directional degree of freedom (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 mounting root (11) of the first tip link (10) and the second proximal mounting root (21) of the second tip link (21) are articulated with each other around the common axis of rotation (Y-Y), defining the relative opening / closing degrees of freedom (G) between the second tip link (20) and the group formed by the first tip link (10) and the blade link (30). An opposing blade surface (24) is provided that rotates integrally with the second tip link (20), The opposing 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, thereby causing the cutting edge (34) of the blade link (30) and the opposing blade surface (24) to reach a state of mechanical interference contact and perform a cutting operation. The first tip link (10) is provided with an axially extending axial deformation seat (14) for receiving the elastic bending of the blade of the blade link (30) during the cutting operation. The aforementioned axial deformation seat portion (14) is Parallel to the opposing blade surface (24), and defined axially by the axially inward surface (18) of the first tip link (10), Needle holder / cutter-type surgical instrument (1).
10. A resistance engagement portion is provided to rotate the blade link (30) integrally with the first tip link (10), A needle holder / cutter-type surgical instrument (1) according to claim 1 or 9.
11. The resistance engagement portion is positioned along the longitudinal extension of the cutting edge (34) of the blade link (30) or distal to the cutting edge of the blade link (30), and / or The resistance engagement portion is provided adjacent to the cutting edge (34) of the blade link (30) or at the distal end of the cutting edge (34). The needle holder / cutter-type surgical instrument (1) according to claim 10.
12. The second end link (20) is equipped with a screw-fastened wall (28), The aforementioned screw-fastened wall (28) The second tip link (20) has a recess (28.1) facing the gripping side (P2) of the main body, which is used to define a recess for receiving the suture wire (6), and maintains contact between the suture wire (6) and the cut edge (34) of the blade of the blade link (30) during cut closure. A needle holder / cutter-type surgical instrument (1) according to claim 1 or 9.
13. The aforementioned articulated end effector (9) is The three components are, namely, the first tip link (10), the second tip link (20), and the blade link (30), and the three components are articulated with respect to the support structure, which includes the two protrusions (3, 4), via the common axis of rotation (Y-Y). Furthermore, there is an additional component which is an articulated pin (5) that defines the common axis of rotation (Y-Y), It consists of, or The aforementioned articulated end effector (9) is The four components articulated on the common rotation axis (Y-Y) are the support link (2), the first end link (10), the second end link (20), and the blade link (30), wherein the support link (2) includes the projections (3, 4), and the four components are articulated on the common rotation axis (Y-Y). Furthermore, there is an additional component which is an articulated pin (5) that defines the common axis of rotation (Y-Y), In addition, a further component is a proximal articular pin that defines the proximal rotation axis (P-P) of the support link (2), It consists of, A needle holder / cutter-type surgical instrument (1) according to claim 1 or 9.
14. The first proximal mounting base (11) of the first tip link (10) integrally includes at least a first end seat (15) for at least one actuating tendon (71, 72) of the first tip link (10) around the common rotation axis (Y-Y), The second proximal mounting base (21) of the second tip link (20) integrally includes at least a second end seat (25) for at least one actuating tendon (73, 74) of the second tip link (20) around the common rotation axis (Y-Y), The support structure, including the two projections (3, 4), is included in a support link (2) articulated with respect to the distal end (8) of the shaft (7) around a proximal rotation axis (P-P), and integrally comprises at least a third end seat (67) for at least one actuation tendon (75, 76) of the support link (2) around the proximal rotation axis (P-P). A needle holder / cutter-type surgical instrument (1) according to claim 1 or 9.
15. A robotic surgical system (101) comprising at least one needle holder / cutter type surgical instrument (1) according to claim 1 or 9.