Surgical instrument

Abstract

The invention relates to the technical field of medical instruments, discloses a surgical instrument, and particularly relates to a shapeable surgical instrument suitable for single-port endoscopic surgery, which comprises an inner rod assembly, an outer rod assembly and a handle assembly. The outer rod assembly is made of annealed metal (such as pure copper or copper alloy), can be shaped by hands and is kept in a bent form; the inner rod is a nickel-titanium alloy multifilament or a stranded rope, and low-resistance rotation in a bending state is achieved. The handle rotating wheel drives the inner rod to rotate and is matched with the axial push-pull of the rear handle, so that the 360-degree real-time angle adjustment and opening and closing actions of the working part (forceps piece / scissors) are controlled by a single hand, and the forceps piece / scissors do not need to be taken out of a body. The problems that a traditional straight rod instrument cannot reach a narrow area, a pre-bending instrument cannot be adjusted in an operation, and an existing shaping instrument needs in-vitro angle adjustment of two hands are solved, the operation efficiency is improved, and the cleaning and sterilizing time is shortened.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a shapeable surgical device suitable for single-port laparoscopy. BACKGROUND

[0002] Single-port laparoscopic surgery (such as single-port laparoscopy and single-port thoracoscopy) introduces devices into the body through a single incision, with the advantages of minimal trauma and rapid recovery, but it puts higher requirements on the flexibility and operating precision of the devices. In the prior art, the structural design of surgical devices has the following key defects: 1. Limitations of traditional straight-bar devices Traditional laparoscopic devices (such as laparoscopic forceps and separating forceps) have rigid stainless steel tubes as their outer rods, which cannot adapt to narrow or curved anatomical structures (such as the mediastinum of the chest and the corner area of the pelvic cavity), and the surgical field coverage rate is less than 60%. For example, in a lung nodule resection surgery, straight-bar devices cannot reach the deep lesions of the interlobar fissure, and the surgical field needs to be exposed by pulling the tissue, increasing the risk of surgical trauma.

[0003] 2. Fixed angle defects of pre-bent devices To solve the problem of straight-bar devices, pre-bent devices (such as 30° / 45° pre-bent laparoscopic forceps) have appeared on the market, whose outer rods are manufactured with a fixed bending angle. However, such devices have two major problems: ① The angle cannot be adjusted intraoperatively; ② The pre-bent angle does not match the patient's anatomy, for example, for pelvic surgery on patients of different sizes, a fixed 45° pre-bent device may not fit the individualized anatomical structure, resulting in a decrease in operating precision.

[0004] 3. Technical bottlenecks of existing shapeable devices In the prior art, some patents attempt to solve the above problems by using shapeable outer rods, but there are still significant defects: shapeable devices that need to be adjusted outside the body: for example, the shapeable surgical device disclosed in comparative patent CN119344828B has a nested fixed structure between the outer rod and the inner rod. When adjusting the angle of the head, the device needs to be completely taken out of the body, and the head gear is driven to rotate by rotating the proximal knob with both hands, increasing the number of times the device is taken in and out of the body and increasing the risk of incision infection.

[0005] Complexity of two-handed operation: most existing shapeable devices require two-handed cooperation (one hand to fix the outer rod and the other hand to rotate the angle adjustment mechanism), and during single-port surgery, the surgeon needs to manipulate multiple devices at the same time, further increasing the difficulty of the operation and leading to an increase in the rate of operating errors.

[0006] 4. Relevance of technical contradictions and the present application Single-port surgical devices need to meet three major core requirements: ① The outer rod can be molded to fit complex anatomical pathways; ② The head angle can be adjusted in real time to accurately locate the lesion; ③ Single-handed operation reduces the operator's workload.

[0007] Current technologies can only meet single needs and cannot achieve the synergy of "intraoperative manual shaping - real-time angle adjustment - single-handed operation". A better solution is still needed. Summary of the Invention

[0008] This invention addresses the aforementioned technological gap by proposing a surgical instrument that integrates a "malleable outer rod + flexible inner rod transmission + single-hand drive mechanism." Through the selection of outer rod materials, the design of the inner rod structure, and the optimization of mechanical transmission (axial limiting + circumferential locking), it solves the problems of traditional instruments being unable to reach narrow areas, pre-bent instruments not being able to be adjusted intraoperatively, and existing malleable instruments requiring external angle adjustment or two-hand operation. This provides an efficient and flexible instrument solution for single-port laparoscopic surgery.

[0009] To achieve the above objectives, the present invention employs the following technical solutions: A surgical instrument rod assembly includes: An inner rod assembly includes a clamp base, an inner rod, and a working part connected to the clamp base, wherein the working part includes at least one of clamp blades, scissors, or separating clamps; An outer rod assembly, which is sleeved on the outside of the inner rod assembly; The clamp seat is provided with a first limiting part and a second limiting part that are axially spaced apart; The outer rod assembly is provided with a third limiting part and a fourth limiting part that are axially spaced apart; The first limiting part and the third limiting part are axially aligned, and the second limiting part and the fourth limiting part are axially aligned, so as to jointly define the axial movement stroke of the clamp seat within the outer rod assembly; The inner rod is connected to the clamp seat, so that the axial movement of the inner rod can drive the clamp seat to move axially until the first limiting part contacts the third limiting part, or the second limiting part contacts the fourth limiting part; when the clamp seat stops moving axially due to the contact of the limiting parts, the continued axial movement of the inner rod will drive the working part to move, including opening or closing action or linear movement.

[0010] Furthermore, the inner rod is connected to the clamp seat, so that the rotational movement of the inner rod can drive the clamp seat and the working part to rotate synchronously; A locking mechanism is provided between the clamp and the outer rod assembly, and the clamp can switch between the following states relative to the outer rod assembly: In the separated state, the clamp can rotate freely relative to the outer rod assembly; In the locked state, the clamp seat is locked to the outer rod assembly by the locking mechanism to prevent relative rotation.

[0011] Furthermore, the locking mechanism includes a cooperating protrusion and a recess, one of which is located on the clamp seat and the other is located on the outer rod assembly.

[0012] Furthermore, the protrusions and recesses are configured to provide at least two locking positions within a 360-degree relative rotation range.

[0013] Furthermore, the protrusion and the recess are interlocking toothed structures.

[0014] Furthermore, the first limiting part and the second limiting part are respectively formed on the first limiting surface and the second limiting surface on the outer surface of the clamp seat; the third limiting part and the fourth limiting part are respectively formed on the third limiting surface and the fourth limiting surface on the outer rod assembly.

[0015] Furthermore, the outer rod assembly includes an outer rod distal end connector and an outer rod distal end nut detachably connected thereto, and at least one of the third limiting surface and the fourth limiting surface is formed on the outer rod distal end nut.

[0016] Furthermore, the outer rod assembly includes an outer rod, which is a tubular member that can be plastically deformed and maintain its shape, and the material includes annealed metal with a yield strength between 50 MPa and 300 MPa. Further, the material of the outer rod includes pure copper or a copper alloy or annealed steel.

[0017] Furthermore, the inner rod is a flexible force transmission element, the structure of which is a rope made of one or more strands twisted together, including steel rope, or monofilaments or multifilaments made of superelastic materials, including nickel-titanium alloy wire.

[0018] Furthermore, the outer diameter of the outer rod is less than 5 mm, and the diameter of the inner rod is less than 1.5 mm.

[0019] A surgical instrument includes a lever assembly as described in any of the aforementioned surgical instruments, and further includes a handle assembly, the handle assembly comprising: The front handle is detachably connected to the outer rod assembly; A rotating wheel is rotatably mounted on the front handle, and the inner rod passes through the rotating wheel and is circumferentially fixed by engaging with it through a non-circular cross section.

[0020] The rear handle is movably connected to the front handle and hinged to the proximal end of the inner rod to drive the inner rod to perform axial linear motion.

[0021] A method of using a surgical instrument, comprising: Step 1: By driving the rear handle to rotate, the inner rod is pushed to move to the distal end, thereby causing the clamp seat to move and separate from the outer rod assembly until the clamp seat is limited by the third limiting surface of the outer rod assembly and stops moving; Step 2: Further drive the rear handle to rotate, and continue to push the inner rod to the distal end. The inner rod drives the working part to perform the first state of movement (such as opening movement) relative to the clamp seat. Step 3: Rotate the wheel on the handle to drive the inner rod to rotate, which in turn drives the clamp seat and the working part to rotate simultaneously. Step 4: After the reverse drive handle rotates, it pulls the inner rod to move towards the proximal end, thereby driving the clamp seat to move and fit against the outer rod assembly until the clamp seat stops moving and is limited by the fourth limiting surface of the outer rod assembly. Step 5: Further drive the rear handle to rotate, and continue to pull the inner rod to move it to the proximal end. The inner rod drives the working part to move relative to the clamp seat in the second state (such as closing movement).

[0022] This invention significantly improves the clinical efficacy of single-port laparoscopic surgery through a synergistic design of "malleable outer rod + flexible inner rod transmission + single-hand integrated drive," with the following specific advantages: 1. Improved surgical efficiency and shorter operation time Real-time angle adjustment without external operation: The outer rod can be shaped and maintained in a bent shape by hand, and with the low resistance rotation of the inner rod's elastic material, the angle can be adjusted in real time with one hand via the handle wheel. This avoids the repetitive operation of "removing-adjusting-inserting" traditional instruments, thus shortening the operation time.

[0023] Reduced instrument replacement frequency: Compared with pre-bent instruments, this invention adapts to different anatomical areas through dynamic shaping during surgery, reducing the number of instrument replacements and further reducing surgical interruption time.

[0024] 2. Improved cleaning and sterilization efficiency reduces the risk of infection. The entire assembly is designed to be independently disassembled: the outer rod and the handle are connected by threads, and the inner rod and the rear handle are quickly separated by a slot. The instrument can be disassembled into three parts: the inner rod assembly, the outer rod assembly, and the handle assembly. The inner hole of the outer rod can be rinsed with a high-pressure water gun, reducing cleaning dead spots. Combined with high-pressure steam sterilization, the sterilization qualification rate is improved and the risk of cross-infection is reduced.

[0025] 3. Optimized instrument compatibility, adaptable to multi-instrument operation in single-port surgery. Minimal diameter and low interference design: The outer diameter of the outer rod is less than 5 mm, and its malleable and flexible shape reduces the probability of "clashing" when multiple instruments are operated in a single incision. It is especially suitable for complex surgeries involving multiple instruments (such as single-port laparoscopic cholecystectomy + common bile duct exploration).

[0026] In summary, this invention solves the technical bottlenecks of insufficient flexibility of traditional straight instruments, fixed angle of pre-bending instruments, and the need for external angle adjustment of existing malleable instruments. Through structural innovation, it achieves full-process optimization of "intraoperative real-time shaping - precise operation - efficient sterilization", and has significant clinical application value. Attached Figure Description

[0027] Figure 1 This is a front view of a surgical instrument rod assembly according to the present invention; Figure 2 This is an exploded view of a surgical instrument rod assembly according to the present invention; Figure 3 This is a cross-sectional view of the outer rod assembly of a surgical instrument rod assembly according to the present invention; Figure 4 This is a cross-sectional view of the inner rod assembly of a surgical instrument rod assembly according to the present invention; Figure 5 This is an exploded view of the inner rod assembly of a surgical instrument rod assembly according to the present invention; Figure 6 This is a rear cross-sectional view of a surgical instrument rod assembly according to the present invention (forceps position 1). Figure 7 This is a rear cross-sectional view of a surgical instrument rod assembly of the present invention (forceps position two). Figure 8 This is a rear cross-sectional view of the surgical instrument rod assembly of the present invention (forceps position three). Figure 9 This is a three-dimensional exploded view of a surgical instrument rod assembly according to the present invention; Figure 10 This is a perspective view of the clamp seat of a surgical instrument rod assembly according to the present invention; Figure 11 This is a perspective view of a surgical instrument rod assembly according to the present invention (step one); Figure 12 This is a perspective view of a surgical instrument rod assembly according to the present invention (step two); Figure 13 This is a perspective view of a surgical instrument rod assembly according to the present invention (step three); Figure 14 This is a perspective view of a surgical instrument rod assembly according to the present invention (step four); Figure 15 This is a schematic diagram of the shaping of a surgical instrument rod assembly according to the present invention; Figure 16 This is another exploded view of a surgical instrument rod assembly according to the present invention; Figure 17 A cross-sectional view of a surgical instrument (including the handle assembly). Figure 18 This is a schematic diagram illustrating the clinical use of a surgical instrument. In the diagram: 10-Inner rod assembly; 11-Inner rod; 12-Clamp seat; 13-Clamp seat pin; 14-First clamping plate; 15-Second clamping plate; 16-Tail shaft; 20-Outer rod assembly; 21-Outer rod; 22-Outer rod distal end connector; 23-Outer rod distal end nut; 24-Handle nut; 30-Handle assembly; 31-Front handle; 32-Rear handle; 33-Rotating wheel; 111-Inner long rod; 112-Inner drive Moving; 113-Inner rod sleeve; 114-Inner rod eccentric pin; 121-First limiting surface; 123-Pliers seat eccentric hole; 122-Second limiting surface; 141-Pliers plate eccentric pin; 142-First clamping plate sliding groove hole; 152-Second clamping plate sliding groove hole; 161-Driving boss; 162-Tail shaft retaining boss; 221-Fourth limiting surface; 222-Thread; 231-Third limiting surface; 321-Receiving groove; Detailed Implementation

[0028] The present invention will now be described in detail with reference to the accompanying drawings.

[0029] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0030] like Figure 1 and Figure 2 As shown, a surgical instrument rod assembly includes an inner rod assembly 10 and an outer rod assembly 20, wherein the outer rod assembly 20 is sleeved on the outside of the inner rod assembly 10. Further as... Figure 3 As shown, the outer rod assembly 20 includes an outer rod 21, the distal end of which is fixedly connected to an outer rod distal end connector 22. The outer rod distal end connector 22 includes a fourth limiting surface 221, forming a fourth limiting portion. The outer rod distal end connector 22 also includes a thread 222. The outer rod assembly 20 also includes an outer rod distal end nut 23, which includes a third limiting surface 231, forming a third limiting portion.

[0031] like Figure 4As shown, the inner rod assembly 10 includes an inner rod 11. The inner rod 11 further includes an inner elongated rod 111, an inner drive 112, and an inner rod sleeve 113. The inner rod sleeve 113 fixes the inner drive 112 and the inner elongated rod 111 together to form an integral connection structure. Those skilled in the art will understand that the inner elongated rod 111, the inner drive 112, and the inner rod sleeve 113 can also be directly processed into an integral part during the manufacturing process to form the inner rod 11. This is the first embodiment. Alternatively, the inner elongated rod 111 and the inner rod sleeve 113 can be manufactured as a detachable connection structure, such as a threaded structure, to facilitate the replacement of components to meet the needs of different types of instrument head shapes and functions. Regardless of which solution is used, it is within the overall scope of the inner rod 11 defined by the inventive concept.

[0032] Further reference Figure 4 and Figure 5The inner rod assembly 10 also includes a clamp seat 12, a clamp seat pin 13, and a first clamp plate 14 and a second clamp plate 15 movably connected to the clamp seat pin 13 and the clamp seat 12. The clamp seat 12 includes a first limiting surface 121 forming a first limiting portion and a second limiting surface 122 forming a second limiting portion. The first clamp plate 14 includes a clamp plate eccentric pin 141 and a first clamp plate sliding groove hole 142. The structure of the second clamp plate 15 is equivalent to that of the first clamp plate 14. The clamp seat 12 includes a clamp seat eccentric hole 123. The inner rod 11 includes an inner rod eccentric pin 114. Along the axial direction of the clamp seat pin 13, the hierarchical structure consists of the first clamp plate 14, the inner rod 11, and the second clamp plate 15, which are inserted into the inner hole of the clamp seat 12, then through the clamp seat pin 13, and then sequentially through one side of the clamp seat 12, the second clamp plate sliding groove hole 152 of the second clamp plate 15 (not shown in the figure, but can be understood by referring to the structure of the first clamp plate 14), the inner rod hole 115 of the inner rod 11, the first clamp plate sliding groove hole 142 of the first clamp plate 14, and the other side of the clamp seat 12. At the same time, the clamp plate eccentric pin 141 of the first clamp plate 14 is engaged in the eccentric hole 123 of the clamp seat. The second clamp plate 15 is installed in the same way, thus realizing the structural assembly. With the clamp seat 12 fixed, driving the inner rod 11 to make linear reciprocating motion along the axial direction can drive the first clamp plate 14 and the second clamp plate 15 to rotate around the clamp seat pin 13 on the clamp seat 12, realizing their opening and closing. Those skilled in the art will understand that the mechanical structure for laparoscopic surgical instruments to achieve the movement of the inner rod driving the movement of the forceps is not limited to the solution proposed in this invention. It also includes mechanisms such as linkage mechanisms and sliding mechanisms, which will not be described in detail here. Their main characteristics are that, with the forceps seat fixed, the forceps can perform corresponding actions by driving the inner rod to continue moving, thereby meeting the action requirements during surgery. Furthermore, the illustrations of this invention show a typical forceps combination. In the field of laparoscopic instruments, this also includes various types of forceps heads, including scissors and dissecting forceps, as well as single-action structures where one forceps moves while the other remains stationary. All these structures can achieve their corresponding functions within the overall inventive concept of this invention. For better summarization and understanding, the first forceps 14 and / or the second forceps 15 can be collectively referred to as the working part, i.e., the component required to perform the work.

[0033] like Figure 6 , 7 Figure 8 shows the detailed cross-sectional view of the head region in three different states after the inner rod assembly 10 and the outer rod assembly 20 are combined. Figure 6 The diagram shows that neither the first nor the second limiting part of the inner rod assembly 10 is in contact with the third or the fourth limiting part of the outer rod assembly 20. In other words, the third or the fourth limiting part defines an axial movement range, and the first and second limiting parts of the clamp seat are within the movement range.Figure 7 The first limiting portion of the clamp seat 12 is shown to contact and limit the contact between the third limiting portion of the outer rod assembly 20. Figure 8 The second limiting portion of the clamp seat 12 is shown to contact and limit the fourth limiting portion of the outer rod assembly 20.

[0034] Those skilled in the art will understand that limiting the movement of the inner rod assembly 10 within a certain range in the axial direction can be achieved through various solutions for its limiting mating surfaces. The first limiting part, the second limiting part, the third limiting part, and the fourth limiting part proposed in this invention can be implemented by selecting different structural positions on the clamp seat 12 and the outer rod assembly 20 (i.e., the outer rod distal end connector 22 or the outer rod distal end nut 23), or by adding new structural components such as the sliding limitation between the pin and the slide groove. As long as the movement of the inner rod assembly 10 relative to the outer rod assembly 20 is limited to a certain range, it is all in line with the concept of this invention.

[0035] The core idea of ​​this invention is to achieve a switching between a separated state and a engaged state for the inner rod assembly 10 (specifically, the clamp seat 12) and the outer rod assembly 20 by realizing the reciprocating motion of the inner rod assembly 10 relative to the outer rod assembly 20 within a moving range. In the separated state, rotating the inner rod assembly 10 allows it to rotate independently around its own axis, thereby causing the working part (clamp plate) to rotate by an angle. In the engaged state, the inner rod assembly 10 (specifically, the clamp seat 12) and the outer rod assembly 20 need to be relatively fixed (including angle fixation). To further demonstrate the functions to be achieved by this invention... Figures 9 to 14 An embodiment is shown in more detail.

[0036] like Figure 9 , 10As shown, the second limiting surface 122 of the clamp seat 12 includes a toothed structure, and the fourth limiting surface 221 of the distal connector 22 of the outer rod also includes a toothed structure. When the two end faces with toothed structures come into contact, the teeth contact each other, forming a locking effect between the protrusion and the recess, thereby achieving axial rotation angle locking between the clamp seat 12 and the distal connector 22 of the outer rod. This scheme allows the clamp seat 12 to rotate relative to the distal connector 22 of the outer rod to approach each other and form an angle lock at the current position after rotating at multiple angle positions. The number of toothed grooves arranged on the circumference determines the number of interlocking angles; the more grooves, the more interlocking angles. Those skilled in the art will understand that using toothed structures on both contact surfaces is a typical interlocking structure, such as the Allied tooth structure. However, it is also possible to choose one surface as a toothed structure and the other surface as a single protrusion or recess to achieve the same effect. Therefore, the protrusion and recess are constructed to provide multiple locking positions within a 360-degree relative rotation range. The present invention proposes at least two locking positions. Simultaneously, by replacing the toothed structure and using two mating surfaces, one of which has a high coefficient of friction or is made of soft rubber, the increased coefficient of friction allows for angular locking of the two parts upon contact. In this angle-locked state, during surgery, as long as the frictional force exceeds the rotational torque exerted by the tissue on the instrument head, the instrument's operational function can be ensured. This implementation scheme allows for angle locking at any angle.

[0037] The operation steps for achieving the separation and engagement states between the inner rod assembly 10 (specifically, the clamp seat 12) and the outer rod assembly 20 through the above structural scheme are illustrated in the following attached diagram: Step 1: Figure 11 As shown (the outer rod distal end nut 23 is hidden), the inner rod 11 in the inner rod assembly 10 is pushed distally, pushing the inner rod 11 away from the outer rod assembly 20, that is, the clamp seat 12 is away from the outer rod distal end connector 22. When the first limiting surface 121 (i.e. the first limiting part) reaches the third limiting surface 231 on the outer rod distal end nut 23, the clamp seat 12 moves to the distal end limit position, further pushing the inner rod 11, which will push the first clamp plate 14 and the second clamp plate 15 to generate an opening movement relative to the clamp seat 12. This process corresponds to the head of a gripper or scissor-type instrument, that is, the process of opening the working part. If it corresponds to the head of a separation clamp-type instrument, it is the process of opening and separating tissue.

[0038] Step 2: Figure 12As shown (the distal nut 23 of the outer rod is hidden), based on step 1, rotating the inner rod 11 can drive the entire inner rod assembly 10 to rotate, thereby adjusting the angle of the instrument head's working part. Compared to traditional laparoscopic surgical instruments, where the rotation of the instrument head is achieved by driving the wheel on the handle side, which in turn drives the outer rod to rotate, and the outer rod and instrument head are relatively fixed during use after assembly (including angle fixation), thus requiring rotation of the outer rod to rotate the instrument head's angle. However, the instrument proposed in this invention does not require the outer rod to rotate while allowing the instrument head's angle to be adjusted during surgery by rotating the inner rod as needed.

[0039] Step 3: Figure 13 As shown, based on the above steps, the inner rod 11 is pulled in the opposite direction towards the proximal end. After the second limiting surface 122 on the clamp seat 12 contacts the fourth limiting surface 221 of the far end connector 22 of the outer rod, the angle between the two is locked, and the clamp seat 12 reaches the end limit position of the proximal end.

[0040] Step 4: Figure 14 As shown, based on the above steps, the inner rod 11 continues to be pulled towards the proximal end. Since the clamp seat 12 has stopped axial movement at this time, the inner rod 11 will drive the first clamp plate 14 and the second clamp plate 15 to rotate relative to the clamp seat 12 towards the center (i.e., the action of closing the clamp plates). This corresponds to the gripping action of the head of the clamp type in the surgical instrument, and the cutting action of the head of the scissor type.

[0041] like Figure 15As shown, the outer rod 21 proposed in this invention is a tubular component that can be plastically deformed and retains its shape after deformation. Furthermore, to enable manual deformation by the surgeon during operation, the outer rod 21 is made of a plastically deformable material with a yield strength between 50 MPa and 300 MPa. When the outer rod is bent into any continuous spatial curve, the rotational torque required to drive the inner rod to rotate about its own axis is no greater than 0.05 N·m. An optional material option includes pure copper, copper alloy, or annealed steel. After the outer rod 21 is plastically bent and deformed, the inner rod 11 needs to simultaneously achieve axial movement along the interior of the bent outer rod 21 and rotational movement along itself, thereby driving the inner rod assembly 10 to perform axial displacement and rotation relative to the outer rod assembly 20. Those skilled in the art will understand that if the inner rod is made of ordinary steel wire (especially with a diameter of 1 mm or more), the wire will also bend within the curved outer rod. When multiple bending is required during surgery, or if the instrument is reusable and the outer rod needs to undergo multiple shaping deformations, the internal steel wire, lacking elastic recovery capability, will harden and form multiple bending points after repeated shaping. This makes it difficult to achieve self-rotation within the narrow inner cavity of the outer rod. Therefore, the inner rod 11 proposed in this invention is a flexible force transmission element. Its structure is a cable made of one or more strands twisted together, such as a steel rope, or a monofilament or multifilament made of a superelastic material, such as a nickel-titanium alloy spool. This material allows for multiple bending deformations and returns to its initial state in a natural state, for example, a straight line after natural drooping. Even after multiple shaping deformations, it can still recover. Simultaneously, the resistance to overcome during rotation within the curved outer rod is small, facilitating one-handed operation by the doctor.

[0042] like Figure 16 As shown, the inner rod assembly 10 further includes a tail shaft 16, which is connected to the inner rod 11. The connection method includes a fixed connection or a detachable connection. The fixed connection includes a welded or deformed compression connection, and the detachable connection includes a threaded connection or a detachable compression fit connection. The tail shaft 16 includes a drive boss 161 and a tail shaft retaining boss 162. The outer rod assembly 20 includes a handle nut 24, which is fitted onto the outside of the outer rod 21 and can slide and rotate along the outer axial direction but cannot be separated.

[0043] like Figure 17As shown, a surgical instrument includes a surgical instrument rod assembly as described in any of the aforementioned embodiments, and a handle assembly 30. The handle assembly 30 includes a front handle 31, a rear handle 32, and a rotating wheel 33. The rotating wheel 33 is rotatably mounted on the front handle 31. The outer rod assembly 20 is detachably threadedly connected to the front handle 31 via a handle nut 24. The inner rod 11 passes through the rotating wheel 33 and is circumferentially fixed by engaging with it through a non-circular cross-section. Furthermore, it rotates synchronously with the rotating wheel by passing through a corresponding mating inner hole in the rotating wheel 33 via a drive boss 161. One feasible embodiment is that the drive boss 161 is a hexagonal cylindrical surface, and the corresponding inner hole of the rotating wheel 33 is a hexagonal cylindrical hole, with the two engaging. The rear handle 32 includes a slot 321, and the tail shaft locking protrusion 162 engages in the slot 321 to achieve a detachable connection with the rear handle 32. The rear handle 32 is movably connected to the front handle 31. During the rotation of the rear handle around the handle pin 34, it drives the inner rod 11 to perform axial linear motion. Achieving axial linear motion between the rear handle and the inner rod is a traditional mechanical structure for laparoscopic instruments, but other structural solutions can also be adopted to achieve the same motion effect.

[0044] Figure 18 This invention demonstrates a single-port thoracoscopic surgery via a mediastinal approach to access lung-related lesions. Utilizing the malleable instrument proposed in this invention, the external rod can be shaped and bent to achieve the desired surgical approach. The instrument head reaches areas inaccessible to traditional straight instruments, thus expanding the surgical scope. Simultaneously, it avoids the problem of existing pre-bent instruments being unable to undergo secondary shaping during surgery, significantly improving surgical efficiency.

[0045] Furthermore, the outer rod has an outer diameter of less than 5 mm, and the inner rod has a diameter of less than 1.5 mm. By carefully designing the outer rod wall thickness and material hardness, combined with the inner rod diameter, the optimal usage parameters for the malleable outer rod are achieved.

[0046] The disassembly steps of the device proposed in this invention are as follows: Step 1: Unscrew the handle nut 24 to separate the front handle 31 on the handle assembly 30 from the outer rod 21 of the outer rod assembly 20; Step 2: Rotate the rear handle (the angle opening process relative to the front handle) to separate the tail shaft locking protrusion 162 on the inner rod 11 from the locking groove 321 of the rear handle 32; Step 3: Pull out the inner rod assembly 10 to separate it from the handle assembly 30; Step 4: Remove the tail shaft 16, unscrew the nut 23 at the far end of the outer rod, and pull out the inner rod 11 (at this point, the inner rod 11, the clamp seat 12, the first clamp plate 14, and the second clamp plate 15 form a complete assembly), thus completing the separation between the inner rod assembly and the outer rod assembly. This allows the entire assembly to be separated into its three independent components.

[0047] Reviewing the aforementioned solutions, the reason why this invention aims to enable the inner rod to drive the instrument head to rotate is because the outer rod needs to be shaped. However, the shaped outer rod does not need to rotate during the operation; otherwise, the shaped angle and position will not change. Unless the outer rod can rotate independently around its own axis even when it is bent, such a structure will greatly increase the manufacturing difficulty and cost of the instrument.

[0048] This invention significantly improves the clinical efficacy of single-port laparoscopic surgery through a synergistic design of "malleable outer rod + flexible inner rod transmission + single-hand integrated drive," with the following specific advantages: 1. Improved surgical efficiency and shorter operation time Real-time angle adjustment without external operation: The outer rod can be shaped and maintained in a bent shape by hand. Combined with the low-resistance rotation of the inner rod's nickel-titanium alloy multifilament, the angle can be adjusted in real time with one hand via the handle wheel. This avoids the repetitive operation of "removing-adjusting-inserting" traditional instruments, thus shortening the operation time.

[0049] Reduced instrument replacement frequency: Compared with pre-bent instruments, this invention adapts to different anatomical areas through dynamic shaping during surgery, reducing the number of instrument replacements and further reducing surgical interruption time.

[0050] 2. Improved cleaning and sterilization efficiency reduces the risk of infection. The entire assembly is designed to be independently disassembled: the outer rod and the handle are connected by threads, and the inner rod and the rear handle are quickly separated by a slot. The instrument can be disassembled into three parts: the inner rod assembly, the outer rod assembly, and the handle assembly. The inner hole of the outer rod can be rinsed with a high-pressure water gun, reducing cleaning dead spots. Combined with high-pressure steam sterilization, the sterilization qualification rate is improved and the risk of cross-infection is reduced.

[0051] 3. Optimized instrument compatibility, adaptable to multi-instrument operation in single-port surgery. Minimal diameter and low interference design: The outer diameter of the outer rod is less than 5 mm, and its malleable and flexible shape reduces the probability of "clashing" when multiple instruments are operated in a single incision. It is especially suitable for complex surgeries involving multiple instruments (such as single-port laparoscopic cholecystectomy + common bile duct exploration).

[0052] In summary, this invention solves the technical bottlenecks of insufficient flexibility of traditional straight instruments, fixed angle of pre-bending instruments, and the need for external angle adjustment of existing malleable instruments. Through structural innovation, it achieves full-process optimization of "intraoperative real-time shaping - precise operation - efficient sterilization", and has significant clinical application value.

[0053] In the figures of this invention, the same or similar reference numerals correspond to the same or similar components. In the description of this invention, it should be understood that if terms such as "upper," "lower," "left," "right," "front," and "rear" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the figure, they are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the terms used to describe positional relationships in the figures are only for illustrative purposes and should not be construed as limiting this invention. For those skilled in the art, the specific meaning of the above-mentioned terms can be understood according to the specific circumstances.

[0054] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may be an intermediate component; when a component is referred to as being "fixed" to another component, it can be directly fixed to the other component or there may be an intermediate component, which can be done by effective means such as bonding, welding, riveting, bolting, etc., which will not be listed in this application; when a component is referred to as being "movable" to another component, it can be done by rotation or sliding.

[0055] This application is not limited to the specific embodiments described above. The invention extends to any new feature or combination disclosed in this specification, as well as any new method or process step or combination disclosed herein.

Claims

1. A surgical instrument rod assembly, characterized in that: Including The inner rod assembly includes a clamp seat, an inner rod, and a working part connected to the clamp seat; An outer rod assembly, which is sleeved on the outside of the inner rod assembly; The clamp seat is provided with a first limiting part and a second limiting part that are axially spaced apart; The outer rod assembly is provided with a third limiting part and a fourth limiting part that are axially spaced apart; The first limiting part and the third limiting part are axially opposite each other, and the second limiting part and the fourth limiting part are axially opposite each other, limiting the axial movement stroke of the clamp seat within the outer rod assembly; The inner rod is connected to the clamp seat, so that the axial movement of the inner rod can drive the clamp seat to move axially until the first limiting part contacts the third limiting part, or the second limiting part contacts the fourth limiting part; when the clamp seat stops moving axially due to the contact of the limiting parts, the continued axial movement of the inner rod will drive the working part to move.

2. The surgical instrument rod assembly according to claim 1, characterized in that: The inner rod is connected to the clamp seat, so that the rotational movement of the inner rod can drive the clamp seat and the working part to rotate synchronously. A locking mechanism is provided between the clamp and the outer rod assembly, and the clamp can switch between the following states relative to the outer rod assembly: In the separated state, the clamp can rotate freely relative to the outer rod assembly; In the locked state, the clamp seat is locked to the outer rod assembly by the locking mechanism to prevent relative rotation.

3. A surgical instrument rod assembly according to claim 2, characterized in that: The locking mechanism includes a cooperating protrusion and a recess, one of which is located on the clamp seat and the other is located on the outer rod assembly.

4. A surgical instrument rod assembly according to claim 3, characterized in that: The protrusions and recesses are configured to provide at least two locking positions within a 360-degree relative rotation range.

5. A surgical instrument rod assembly according to claim 3, characterized in that: The protrusions and recesses are interlocking toothed structures.

6. A surgical instrument rod assembly according to claim 1, characterized in that: The first limiting part and the second limiting part are respectively formed on the outer surface of the clamp seat as a first limiting surface and a second limiting surface; The third limiting part and the fourth limiting part are respectively formed on the third limiting surface and the fourth limiting surface of the outer rod assembly.

7. A surgical instrument rod assembly according to claim 6, characterized in that: The outer rod assembly includes an outer rod distal end connector and an outer rod distal end nut detachably connected thereto, wherein at least one of the third limiting surface and the fourth limiting surface is formed on the outer rod distal end nut.

8. A surgical instrument rod assembly according to claim 1, characterized in that: The outer rod assembly includes an outer rod, which is a tubular member that can be plastically deformed and maintain its shape. The material includes annealed metal with a yield strength between 50 MPa and 300 MPa.

9. A surgical instrument rod assembly according to claim 1, characterized in that: The inner rod is a flexible force transmission element, and its structure is a rope made of one or more strands twisted together, or a monofilament or multifilament made of a super-elastic material.

10. A surgical instrument, characterized in that: The surgical instrument lever assembly includes any one of the surgical instrument lever assemblies as described in claims 1 to 9, and further includes a handle assembly, the handle assembly comprising: The front handle is detachably connected to the outer rod assembly; A rotating wheel is rotatably mounted on the front handle, and the inner rod passes through the rotating wheel and is circumferentially fixed by engaging with it through a non-circular cross section; The rear handle is movably connected to the front handle and hinged to the proximal end of the inner rod to drive the inner rod to perform axial linear motion.

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