An adjustable bending medical instrument

Abstract

An adjustable bending medical device includes a sheath, a drive mechanism, and two sets of bending assemblies. Each bending assembly includes at least one bending wire. The distal ends of the bending wires belonging to the same bending assembly are located in the same radial plane of the sheath. The distal ends of the bending wires in the two sets of bending assemblies are located at different circumferential positions of the sheath and are connected to the distal end of the sheath. The distal ends of the bending wires in the two sets of bending assemblies are located in different radial planes of the sheath. The proximal ends of the bending wires in both sets of bending assemblies extend out of the sheath and are connected to the drive mechanism. Under the action of the drive mechanism, the two sets of bending assemblies can drive the sheath to bend in two different bending planes. The adjustable bending medical device of the present invention can realize three-dimensional spatial adjustment of the distal end of the sheath and is suitable for use in interventional surgery.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to an adjustable medical device. Background Technology

[0002] Interventional surgery is a surgical procedure performed via vascular access, guided by medical imaging equipment and utilizing appropriate interventional devices such as guidewires and catheters, for diagnosis and treatment. Interventional surgery offers advantages such as low invasiveness, minimal trauma, and fewer complications and risks. During interventional procedures, to accommodate different purposes and the anatomical morphology of specific lesion sites, the distal end of the sheath (the end furthest from the operator) is typically pre-shaped into various bends. Different models of pre-bent sheaths correspond to different pre-bending angles and bend shapes, facilitating selection by medical personnel. When selecting a sheath, medical personnel first observe the lesion location with the assistance of medical imaging equipment such as DSA (Digital Subtraction Angiography) and ultrasound, and then choose a pre-shaped sheath with a similar bend shape based on their assessment. Due to observational errors and individual differences, it is difficult to select a suitable sheath on the first attempt. When this happens, medical staff usually need to remove the sheath and re-insert a different type. This current procedure requires hospitals to prepare a large number of different sheath types to meet varying bending requirements. More importantly, the repeated sheath selection process can damage the patient's blood vessels, increasing surgical risks, prolonging the interventional procedure time, and increasing the radiation exposure time for both patients and medical staff, posing safety hazards. Based on these considerations, distally adjustable sheaths have been developed in recent years. These sheaths use an external handle in conjunction with an adjusting wire fixed inside the sheath to adjust the distal bending angle, meeting the needs of interventional procedures.

[0003] Existing adjustable bending sheaths can only bend in the same plane at their distal end. This makes them unsuitable when the implantation site has complex physiological and anatomical structures, such as in transcatheter left atrial appendage occlusion. Figure 1As shown, in transcatheter left atrial appendage occlusion, the sheath travels along the guidewire through the inferior vena cava to the right atrium, then through the interatrial septum puncture point to the left atrium, and finally to the left atrial appendage. Due to the physiological anatomy of the heart and the location of the left atrial appendage, the surgeon needs to puncture at a position slightly posterior to the interatrial septum. In practice, due to varying surgeon skill levels, the accuracy of the interatrial septum puncture point cannot be guaranteed. If the puncture point is not accurately selected, the angle between the inferior vena cava and the interatrial septum puncture point will not be in the same plane as the angle between the left atrial appendage and the interatrial septum puncture point. After passing through the interatrial septum, the sheath will be on a different plane from the left atrial appendage. Although the distal end of existing adjustable sheaths can be adjusted, the angle can only be adjusted within a single plane, not in three-dimensional space. This makes it difficult to adjust the sheath to be in the same plane as the left atrial appendage, hindering the delivery of the implantable device to the target site. Therefore, existing adjustable sheaths can only be bent within a single plane, making it difficult to reach the target site when dealing with complex physiological anatomy, thus affecting the surgical procedure. Summary of the Invention

[0004] This invention overcomes the shortcomings of existing adjustable bending sheaths, which can only be bent in the same plane and are difficult to reach the target site when facing complex physiological and anatomical structures, thus affecting surgical operation. It provides an adjustable bending medical device.

[0005] The technical solution adopted by the present invention to achieve the purpose of the invention is as follows: an adjustable medical device is provided, including a sheath, a driving mechanism and two sets of adjusting components. The adjusting components include at least one adjusting wire. The distal ends of the adjusting wires belonging to the same adjusting component are located in the same radial plane of the sheath. The distal ends of the adjusting wires of the two sets of adjusting components are located at different circumferential positions of the sheath and are connected to the distal end of the sheath. The distal ends of the adjusting wires in the two sets of adjusting components are located in different radial planes of the sheath. The proximal ends of the adjusting wires of the two sets of adjusting components extend out of the sheath and are connected to the driving mechanism. Under the action of the driving mechanism, the two sets of adjusting components can drive the sheath to bend in two different adjusting planes.

[0006] The beneficial effects of the present invention are: the adjustable bending medical device of the present invention has bending wires connected to different radial planes of the sheath. The bending wires of different adjustable components are located in the circumferential position of the sheath. Through the driving mechanism, different sections of the sheath can be bent along different planes, which can realize the adjustment of the spatial position of the sheath in three-dimensional space. This allows the device to accurately reach the target site even when facing relatively complex physiological and anatomical structures, thus meeting the requirements of surgery.

[0007] The present invention will now be further described with reference to the accompanying drawings and specific embodiments. Attached Figure Description

[0008] Appendix Figure 1 This is a schematic diagram of sheath insertion during left atrial appendage occlusion.

[0009] Appendix Figure 2 This is a perspective view of the adjustable bending medical device of the present invention.

[0010] Appendix Figure 3 This is a cross-sectional schematic diagram of the sheath of the present invention.

[0011] Appendix Figure 4 for Figure 3 A cross-sectional view along A–A.

[0012] Appendix Figure 5A This is an exploded view of the adjustable bending medical device of the present invention.

[0013] Appendix Figure 5B For the appendix Figure 5A A magnified view of B in the middle.

[0014] Appendix Figure 6 This is an assembly diagram of the knob, drive mechanism, and knob base of the present invention.

[0015] Appendix Figure 7 This is a schematic diagram of the installation of the bending wire and drive mechanism of the present invention.

[0016] Appendix Figure 8 This is a schematic diagram of the assembly of the knob and the drive mechanism of the present invention. Figure 1 .

[0017] Appendix Figure 9 This is a schematic diagram of the transmission rod of the present invention.

[0018] Appendix Figure 10 This is a schematic diagram of the assembly of the knob and the drive mechanism of the present invention. Figure 2 .

[0019] Appendix Figure 11 This is a schematic diagram of the winding post of the present invention.

[0020] Appendix Figure 12 This is a schematic diagram of the assembly of the two transmission rods and two winding columns of the present invention.

[0021] Appendix Figure 13 For the appendix Figure 12 Top view.

[0022] In the attached diagram, 1 is an adjustable bending device, 10 is a sheath, 11 is an adjustable bending section, 12 is a bending wire channel, 20 is a drive mechanism, 21 is a drive mechanism unit, 211 is a mounting base, 212 is a transmission component, 2121 is a transmission rod, 2122 is a worm gear, 2123 is a gear, 2124 is an idler wheel, 213 is a winding component, 2131 is a winding post, 2132 is a worm gear, 2133 is a winding groove, 2134 is a bending wire fixing assembly, 2135 is a bending wire fixing piece, 2136 is a fixing piece slot, 30 is a bending assembly, 31 is a bending wire, 40 is a handle, 41 is a housing, 411 is an outer shell, 412 is a distal end cover, 413 is a knob seat, 4131 is an opening, 4132 is a retaining ring, 414 is a proximal end cover, 42 is a knob, and 43 is a Luer connector. Detailed Implementation

[0023] As attached Figure 2 As shown, an adjustable medical device 1 according to this embodiment includes a sheath 10 and a handle 40.

[0024] As attached Figure 3 As shown, the sheath 10 is a medical catheter with a certain wall thickness, forming a delivery cavity for delivering implants. In this embodiment, the sheath 10 is a straight tube in its natural state. The sheath 10 includes two adjustable bends 11 located at its distal end and spaced apart from each other. The two adjustable bends 11 are spaced apart from each other along the length direction of the sheath 10, and each adjustable bend 11 has a certain extension length along the length direction of the sheath 10. The adjustable bends 11 have lower bending strength than other sections of the sheath 10, and can be bent when subjected to tensile force. Of course, in other embodiments, the adjustable bends 11 with lower bending strength may not be provided.

[0025] As attached Figure 4 As shown, the sheath tube 10 has a bending wire channel 12 inside its wall, and a wire outlet communicating with the bending wire channel 12 on its wall, for the bending wire 31 to pass through the inner wall of the sheath tube 10. The bending wire channel 12 is respectively arranged in a one-to-one correspondence with the bending wires 31 of the two sets of bending components 30, that is, the bending wires 31 of the two sets of bending components 30 are correspondingly inserted into the bending wire channel 12. The bending wire channel 12 is lined with a PTFE (Polytetrafluoroethylene) inner tube, which has good self-lubricating properties and can reduce the sliding resistance of the bending wire 31 during bending.

[0026] As attached Figure 3 and attached Figure 4As shown, the adjustable medical device 1 in this embodiment also includes two sets of adjustment components 30. The two sets of adjustment components 30 are arranged at intervals along the length direction of the sheath 10, and the structures of the two sets of adjustment components 30 are roughly the same. The structure of one of the adjustment components 30 will be described in detail below.

[0027] In this embodiment, the bending assembly 30 includes two bending wires 31 and an anchoring ring 33. The anchoring ring 33 can be located on the distal side of the adjustable bending section 11 or inside the adjustable bending section 11, as long as it is located on the distal side of the proximal end of the adjustable bending section 11. In this embodiment, the anchoring ring 33 is located on the distal side of the distal end of the adjustable bending section 11. The anchoring ring 33 is fixedly installed inside the wall of the sheath tube 10, and the central axis of the anchoring ring 33 can be parallel to or coincide with the central axis of the sheath tube 10. In this embodiment, the central axis of the anchoring ring 33 coincides with the central axis of the sheath tube 10.

[0028] The distal ends of the two bending wires 31 of the bending assembly 30 are fixedly connected to the anchoring ring 33, so that the distal end of the anchoring ring 33 can be regarded as the distal end of the two bending wires 31 connected to it. That is, the distal ends of the two bending wires 31 belonging to the same bending assembly 30 can be regarded as being located in the same radial plane, that is, the distal ends of the two bending wires 31 belonging to the same bending assembly 30 can be regarded as being located in the same radial plane of the sheath 10.

[0029] The bending wires 31 of the two bending assemblies 30 are arranged in a one-to-one correspondence with the bending wire channels 12. The proximal ends of the bending wires 31 of the two bending assemblies 30 pass through the wall of the sheath tube 10 through the bending wire channels 12 and are connected to the drive mechanism. The bending wires 31 of the two bending assemblies 30 are located in the axial plane of the anchoring ring 33, thereby ensuring that the bending wires 31 inside the sheath tube 10 are located in the axial plane of the sheath tube 10. When the drive mechanism applies traction to the bending assembly 30, the sheath tube 10 can be bent within this plane.

[0030] This embodiment includes two sets of bending adjustment components 30. The distal ends of the bending wires 31 in the two sets of bending adjustment components 30 are located in different radial planes of the sheath 10, that is, the anchoring rings 33 of the two sets of bending adjustment components 30 are located in different radial planes of the sheath 10. Therefore, when the driving mechanism applies traction to the two sets of bending adjustment components 30, different sections of the sheath 10 can be bent. The distal ends of the bending wires 31 in the two sets of bending adjustment components 30 are located in different circumferential positions of the sheath 10, that is, any one of the bending wires 31 in the two sets of bending adjustment components 30 does not coincide along the circumference of the sheath 10. Therefore, in addition to bending different sections of the sheath 10, the driving mechanism can also bend different sections of the sheath 10 in different directions, realizing three-dimensional spatial adjustment and more accurately adjusting the spatial position of the sheath 10. Even when facing more complex physiological and anatomical structures, it can accurately reach the target site and meet the surgical requirements. During bending, when the drive mechanism applies traction to one bending wire 31, it simultaneously releases another bending wire. Since each bending assembly 30 includes two bending wires 31, the drive mechanism drives each bending assembly 30 to bend the sheath 10 in two directions, which can greatly increase the applicable scenarios of the adjustable bending medical device 1.

[0031] In this embodiment, the anchoring rings 33 of the two sets of bending components 30 are arranged in a one-to-one correspondence with the two adjustable bending sections 11. One anchoring ring 33 is located on the far side of the adjustable bending section 11 near the far end of the sheath tube 10, and the other anchoring ring 33 is located between the two adjustable bending sections 11, so that the far ends of the bending wires 31 in the two sets of bending components 30 are located in different radial planes of the sheath tube 10, so that the far ends of the bending wires 31 in the two sets of bending components 30 maintain a distance along the length direction of the sheath tube 10.

[0032] It should be noted that in other embodiments, each bending assembly 30 may also include only one bending wire 31. As long as the distal ends of the bending wires 31 of the two sets of bending assemblies 30 are located at different circumferential positions of the sheath 10, and the distal ends of the bending wires 31 of the two sets of bending assemblies 30 are located in different radial planes of the sheath 10, different sections of the sheath 10 can be bent in different directions, that is, the sheath 10 can also be bent in three-dimensional space.

[0033] In one embodiment, the bending wires 31 of the two sets of bending components 30 are partially distributed in mutually perpendicular axial planes within the sheath tube 10. Under the pulling action, the bending wires 31 of the two sets of bending components 30 can drive the sheath tube 10 to bend in two mutually perpendicular bending planes.

[0034] As shown in Figure 5, the handle 40 of this embodiment includes: a housing 41 with a handle cavity, a knob 42, and a pipe connector 43. The housing 41 includes an outer shell 411, a distal end cover 412, a knob seat 413, and a proximal end cover 414. The knob seat 413 has an opening 4131 for exposing a portion of the structure located therein through the opening 4231, which is linked with the knob 42.

[0035] The distal end cover 412 and the knob seat 413 are provided with through holes for the sheath tube 10 to pass through, and the proximal end of the sheath tube 10 is inserted into the outer casing 411 through the through holes.

[0036] One end of the knob seat 413 is fixedly connected to the distal end cover 412, the other end of the knob seat 413 is fixedly connected to the outer shell 411, and the rear end cover 414 is fixedly connected to the outer shell 411, assembling into a complete cavity structure.

[0037] The proximal end of the sheath 10 is connected to the connector 43 to form a delivery channel. This delivery channel passes through the cavity structure of the handle 40 and can be used to deliver implants, such as surgical instruments. To prevent the implant from being pushed unsmoothly in the modular delivery channel, the continuity, integrity, and fixation relative to the housing 41 of the delivery channel must be ensured. Both the sheath 10 and the connector 43 are fixedly connected to the housing 41. This fixed connection transforms the modular delivery channel into a single, non-segmentable, and non-rotatable structure, solving the problems of twisting and uncontrollable position of the implant during delivery caused by relative rotation of a segment in the modular delivery channel. This facilitates implant delivery. In this embodiment, the connector 43 is a Luer connector.

[0038] There are two knobs 42, which are rotatably mounted on the housing 41. In this embodiment, both knobs 42 are mounted on a knob base 413. The knob base 413 has a set of openings 4131. A spacer ring 4132 is also fitted on the knob base 413 to separate two adjacent knobs 42 and prevent accidental activation of one knob 42 when turning the other. The adjusting screw 31 knob 42 is located at the far end of the handle 40, which is ergonomic and convenient for operation and grip.

[0039] As shown in Figure 5 and Appendix Figure 6As shown, the adjustable medical device 1 in this embodiment also includes a drive mechanism 20, which further includes two drive units 21, each corresponding to an adjusting component 30. One drive unit 21 pulls the adjusting component 30 near the proximal end of the sheath 10, causing the sheath 10 to bend along a plane, resulting in overall bending deformation. The other drive unit 21 then pulls the adjusting component 30 near the distal end of the sheath 10, causing the sheath 10 to bend in another plane, thus achieving bending of the sheath 10 in two different planes. In this embodiment, when one drive unit 21 pulls one adjusting wire 31 of the adjusting component 30, it simultaneously releases the other adjusting wire 31, thereby achieving overall pulling of the adjusting component 30.

[0040] As shown in Figure 5 and Appendix Figure 6 As shown, in this embodiment, the two drive units 21 of the drive mechanism 20 are located inside the handle cavity of the handle 40, and the two drive units 21 are connected to the housing 41 of the handle 40 via mounting bases 211. Each drive unit 21 is correspondingly positioned to a knob 42, with one drive unit 21 controlled by one knob 42. The installation positions of both drive units 21 correspond to the positions of the openings 4131. Each drive unit 21 is connected to the end of its corresponding bending wire 31, allowing for the pulling and releasing of the bending wire 31 to adjust the shape of the sheath 10. Medical personnel rotate the knob 42 to rotate the corresponding drive unit 21, pulling and winding the bending wire 31 fixed on the drive unit 21, thus controlling the pulling and releasing of the bending wire 31. When the bending wire 31 is pulled, the sheath 10 bends; when the bending wire 31 is released, the sheath 10 returns to a straight tube. The bending process can be operated with one hand, allowing the medical personnel to use their other hand to push the implant into the sheath 10. In this embodiment, the two drive units 21 have the same structure, only the arrangement direction is different. The two are at a certain angle along the circumference of the sheath tube 10. In this embodiment, the two drive units 21 are preferably arranged at a perpendicular angle. Of course, in other embodiments, they can also be arranged at other angles (e.g., 60°, 30°, etc.).

[0041] As attached Figure 7As shown, the drive unit 21 in this embodiment includes two winding components 213, both of which are linked to the knob 42. The two winding components 213 are located on both sides of the sheath tube 10. A bending wire 31 is correspondingly arranged with each winding component 213. The corresponding bending wires 31 and winding components 213 are located on the same side of the sheath tube 10. Each bending wire 31 extends from the radial gap between the sheath tube 10 and the winding component 213 and is connected to its corresponding winding component 213. Using this wire exit method, the wire exit angle is small, and the pulling force applied to the bending wire 31 is mainly longitudinal, with a smaller lateral (i.e., radial force along the sheath tube 10) component, resulting in smoother and less effort-intensive bending. After the two bending wires 31 of the same bending assembly 30 pass through the wire exit port of the sheath tube 10, they are respectively wound around the two winding components 213. When the winding component 213 rotates, one bending wire 31 is pulled while the other is released. The pulled bending wire 31 pulls the sheath 10 fixed to it, causing the sheath 10 to bend in one direction. Similarly, when the winding component 213 rotates in the opposite direction, the other bending wire 31 is pulled, causing the sheath 10 to bend in the opposite direction. In this embodiment, the sheath 10 can be bent in both directions, and can be adjusted to the most suitable angle without external rotation of the sheath 10, thus adapting to more complex anatomical structures.

[0042] As attached Figure 7 As shown, the drive unit 21 in this embodiment also includes two transmission components 212. The transmission components 212 are located between the two winding components 213, and the transmission components 212 are linked with the two winding components 213. The transmission components 212 and the winding components 213 are encapsulated together by the mounting base 211 and are fixedly installed in the knob base 413. The inner wall of the knob 42 is provided with an internal gear ring. The knob 42 is fitted on the knob base 413. Part of the transmission structure of the transmission component 212 is exposed from the opening 4131 of the knob base 413 and meshes with the internal gear ring of the knob 42. The transmission component 212 is linked with the knob 42. During the bending process, the knob 42 is rotated, and the internal gear ring of the knob 42 meshes with the transmission component 212. The transmission component 212 transmits the torque applied to the knob 42 by the operator to the winding components 213. The knob 42 can drive the two winding components 213 to rotate through the transmission component 212. The control structure has the advantages of compact structure, stability and reliability, and labor saving.

[0043] As attached Figure 8 As shown, the transmission component 212 in this embodiment includes a transmission rod 2121. To save space, multiple transmission elements are integrated on the transmission rod 2121. (See attached diagram.) Figure 9As shown, the transmission rod 2121 includes a worm gear 2122 and a gear 2123 coaxially connected. The worm gear 2122 is used to cooperate with the winding component 213, and the gear 2123 is used to cooperate with the internal gear ring of the knob 42, so that the knob 42 drives the transmission rod 2121 to rotate. The number of gears 2123 can be at least one. In this embodiment, there are two gears 2123, which are located on both sides of the worm gear 2122. In other embodiments, the number of gears 2123 can be at least one, or there can be multiple gears 2123, which are arranged longitudinally on both sides or one side of the worm gear 2122.

[0044] Please refer to the appendix again. Figure 8 To prevent interference with other transmission structures due to structural space limitations when the gear 2123 of the transmission rod 2121 directly meshes with the knob 42, the transmission component 212 in this embodiment also includes an idler wheel 2124. The idler wheel 2124 is arranged parallel to the axis of the transmission rod 2121 and parallel to the axis of the knob 42. The idler wheel 2124 is positioned between the knob 42 and the gear 2123 for transmission. To ensure transmission balance, the transmission rod 2121 in this embodiment has two gears 2123, which are connected to the worm gear 2122 on both sides. The tooth width of the idler wheel 2124 corresponds to the tooth width at both ends of the gear 2123 of the transmission rod 2121, and the idler wheel 2124 meshes with the gears 2123 at both ends of the transmission rod 2121. When adjusting knob 42, the internal gear ring of knob 42 drives idler wheel 2124, which in turn transmits the rotational motion to gears 2123 at both ends of transmission rod 2121. For smooth meshing of gears 2123, self-lubricating polymer or metal materials are used. Idler wheel 2124, transmission rod 2121, and worm gear 2132 mesh to form a transmission unit.

[0045] As attached Figure 8As shown, in this embodiment, both winding components 213 include winding posts 2131 for winding the bending wire 31. The two winding posts 2131 are located on both radial sides of the sheath tube 10, and on both radial sides of the worm gear 2122. Each winding post 2131 is equipped with a worm wheel 2132 that meshes with the worm gear 2122, causing the worm gear 2132 to rotate. The two winding posts 2131 are positioned on both sides of the transmission rod 2121, with the transmission rod 2121 perpendicular to the axis of the winding posts 2131. The knob 42 is parallel to the axis of the transmission rod 2121, and the gear 2123 of the transmission rod 2121 meshes with the internal gear ring of the knob 42 to drive the two winding posts 2131 to rotate. Driven by knob 42, gear 2123 of transmission rod 2121 rotates, and worm gear 2122 of transmission rod 2121 rotates accordingly, which in turn drives worm wheel 2132 of winding post 2131 to rotate, ultimately causing the entire winding post 2131 to rotate. The end of bending wire 31 is fixedly connected to winding post 2131, and bending wire 31 rotates along with it, being pulled and wound. The self-locking structure of worm gear can self-lock at any position after knob 42 is released.

[0046] In other embodiments, if the number of bending wires 31 in both sets of bending components 30 is one, then the number of corresponding winding components 213 is also one, as long as the winding components 213 can wind and release the bending wires 31.

[0047] As attached Figure 8 As shown, to ensure balanced force, this embodiment symmetrically arranges two sets of transmission structures along the diameter of the knob 42. There are two worm gears 2132 on the winding post 2131, located at both ends of the winding post 2131. Two sets of transmission rods 2121 and idler gears 2124 are symmetrically arranged along the diameter of the knob 42. The two winding posts 2131 are positioned on both sides of a pair of transmission rods 2121, and the worms 2122 of the two transmission rods 2121 mesh with the worm gears 2132 at one end of each winding post 2131. The knob 42 drives the pair of transmission rods 2121 to rotate via the idler gears 2124. The worm 2122 of one transmission rod 2121 drives the worm gear 2132 at one end of each winding post 2131 to rotate, and the worm 2122 of the other transmission rod 2121 drives the worm gear 2132 at the other end of each winding post 2131 to rotate. Of course, as shown in the attached... Figure 10 As shown, in another embodiment, only one transmission structure can be provided, and the knob 42 drives the two winding posts 2131 to rotate through only one transmission rod 2121.

[0048] As attached Figure 11As shown, the winding post 2131 of this embodiment is also provided with a winding groove 2133, which can restrict the winding position of the bending wire 31 on the winding post 2131. The winding groove 2133 is arranged along the axial direction of the winding post 2131, and the winding groove 2133 is recessed radially inward along the winding post 2131. During the rotation of the winding post 2131, the bending wire 31 is wound in the winding groove 2133. The winding post 2131 of this embodiment is also provided with a bending wire 31 fixing assembly 2134 for fixing the bending wire 31 to the winding post 2131. The bending wire 31 fixing assembly 2134 includes a bending wire 31 fixing member 2135 and a fixing member slot 2136 provided on the winding post 2131. The size of the fixing member slot 2136 corresponds to the bending wire 31 fixing member 2135. The bending wire 31 fixing member 2135 is inserted into the fixing member slot 2136. The bending wire 31 is connected to the bending wire 31 fixing member 2135. To prevent the bending wire 31 fixing member 2135 from falling out of the fixing member slot 2136, the bending wire 31 fixing member 2135 in this embodiment has a conical structure with a conical angle of 5° to 7° on the outer surface, and can be made of metal alloys such as stainless steel and brass. The bending wire 31 fixing member 2135 has a slot, and the bending wire 31 is tied to the slot. The winding post 2131 has a bending wire channel 12 that communicates with the fixing member slot 2136. One end of the bending wire 31 is connected to the bending wire 31 fixing member 2135, and the other end of the bending wire 31 passes through the bending wire channel 12 and exits from the post of the winding post 2131. The direction of the tension applied to the bending wire 31 is consistent with the direction of the insertion of the bending wire 31 fixing member 2135 into the fixing member slot 2136. When the bending wire 31 is tightened, the tension applied to the bending wire 31 tightly fits the conical surface of the bending wire 31 fixing member 2135 with the inner wall surface of the fixing member slot 2136, and the bending wire 31 located between the two is pressed tight to ensure that the bending wire 31 will not slip.

[0049] To ensure smooth meshing, the transmission ratio between the worm gear 2132 and the worm 2122 ranges from 7.5 to 13; in this embodiment, a transmission ratio of 8 is selected. The worm gear 2132 has 30 to 40 teeth; in this embodiment, 32 teeth are selected. The worm 2122 meshing with it has a multi-start thread; in this embodiment, a four-start thread is selected. The transmission ratio between the gear 2123 and the knob 42 ranges from 4 to 7.5; in this embodiment, a transmission ratio of 5 is selected. The gear 2123 has 20 to 30 teeth; in this embodiment, 26 teeth are selected. The knob 42 has 120 to 150 teeth; in this embodiment, 140 teeth are selected.

[0050] In this embodiment, after the two bending wires 31 of the same bending assembly 30 are led out from the sheath 10, the bending wires 31 extend from the radial gap 213 between the sheath 10 and the winding component, and are wound in the winding groove 2133 on the same side. The winding directions of the two bending wires 31 are opposite. The knob 42 drives the two winding posts 2131 to rotate in the same direction through the transmission rod 2121, so that one bending wire 31 is pulled and the other bending wire 31 is released.

[0051] As attached Figure 12-13 As shown, to achieve co-rotation in a compact structure, the worm 2122 of the transmission rod 2121 in this embodiment is provided with two intersecting helical lines. The tooth direction of the worm wheel 2132 of the winding post 2131 corresponds to the helical line on the same side. That is, the tooth directions of the worm wheels 2132 on both sides of the worm 2122 are opposite. Through the design of the bi-directional intersecting helical lines, the worm wheels 2132 of the two winding posts 2131 mesh with the worm 2122 and rotate in the same direction. Rotating the knob 42, the worm 2122 is driven to rotate through the gear meshing transmission. The bi-directional intersecting helical lines on the worm 2122 cause the worm wheels 2132 with opposite tooth directions on both sides to rotate in opposite directions. This simultaneously controls the two bending wires 31. When one bending wire 31 is pulled, the other bending wire 31 is released, realizing the bending of the distal end of the sheath tube 10 in two directions on the same plane. In order to bring the winding post 2131 closer to the central axis of the sheath tube 10, the purpose of reducing the wire exit angle is achieved. In another embodiment, the outer edge of the sheath 1030 is provided with a cutting portion, and the sheath 1030 can accommodate at least a portion of the winding post 2131.

[0052] In actual operation, medical staff hold the handle 40 with one hand and adjust the bending shape of the distal end of the sheath 10 in sections. First, rotate a knob 42 in one direction. This knob 42 drives the corresponding transmission component 212 to rotate, causing the winding component 213 to rotate. This pulls the bending wire 31 wound on the winding component 213, causing the distal end of the sheath 10 to bend to one side. Similarly, rotating the knob 42 in the opposite direction causes the distal end of the sheath 10 to bend to the other side. After the current bending angle of the sheath 10 is adjusted to the correct position, rotate another knob 42, following the same steps, to bend the sheath 10 in another plane.

[0053] The above description is only a preferred embodiment of this application and does not limit the implementation method and protection scope of this application. Those skilled in the art should realize that all solutions obtained by equivalent substitutions and obvious changes made based on the description and illustrations of this application should be included within the protection scope of this application.

Claims

1. An adjustable bending medical device, characterized in that, The device includes a sheath, a drive mechanism, and two sets of bending assemblies. Each set of bending assemblies includes two bending wires. The drive mechanism includes two drive units with identical structures, arranged perpendicularly to each other along the circumference of the sheath. Each drive unit corresponds to one set of bending assemblies. The distal ends of the bending wires belonging to the same bending assembly are located in the same radial plane of the sheath. The distal ends of the bending wires in the two sets of bending assemblies are located at different circumferential positions in the sheath and are connected to the distal end of the sheath. The distal ends of the bending wires in the two sets of bending assemblies are located in different radial planes of the sheath. The proximal ends of the bending wires in both sets of bending assemblies extend out of the sheath and are respectively connected to the two drive units. The two bending wires belonging to the same bending assembly extend along the same axial plane of the sheath. The portions of the bending wires in the two sets of bending assemblies within the sheath are distributed in two mutually perpendicular axial planes. Under the pulling action of the drive mechanism, the bending wires of the two sets of bending components can drive the sheath to bend in two mutually perpendicular bending planes. The adjustable bending medical device also includes a handle connected to the sheath. The handle includes a housing and two adjacent knobs rotatably disposed on the housing. The two knobs can be rotated by external force to drive the corresponding drive unit to move, thereby pulling or releasing the bending wire. The drive unit includes a winding component, which is arranged in a one-to-one correspondence with the bending wire. Both winding components are linked to the knob and are located on opposite sides of the sheath. The two winding components of one drive unit are arranged perpendicularly to the two winding components of the other drive unit. ， The bending wires and the winding components are arranged in a one-to-one correspondence. The bending wires and the winding components arranged in a corresponding manner are located on the same side of the sheath. All four bending wires extend from the radial gap between the sheath and the winding components, and are respectively connected to their corresponding winding components in two mutually perpendicular axial planes.

2. The adjustable bending medical device according to claim 1, characterized in that... The two bending wires belonging to the same bending assembly are arranged radially opposite each other along the sheath. When the driving mechanism applies tension to one bending wire of the bending assembly, it can release the other bending wire of the bending assembly.

3. The adjustable bending medical device according to claim 1, characterized in that, The sheath includes two adjustable bends spaced apart from each other along its length. The two sets of adjusting components are arranged in a one-to-one correspondence with the two adjustable bends. The distal end of the adjusting wire of one adjusting component is located on the distal side of the adjustable bend near the distal end of the sheath, and the distal end of the adjusting wire of the other adjusting component is located between the two adjustable bends.

4. The adjustable bending medical device according to claim 1, characterized in that, The knob causes the two winding components to rotate in the same direction.

5. The adjustable bending medical device according to claim 1, characterized in that, The drive unit includes at least one transmission component, which is linked to the knob and also linked to the two winding components. The knob can drive the two winding components to rotate through the transmission component.

6. The adjustable bending medical device according to claim 5, characterized in that, The transmission component is one in number, and the transmission component includes a transmission rod, which includes a worm gear and a gear coaxially connected. Both winding components include winding posts, and both winding posts are provided with worm wheels that mesh with the worm gear. The two winding posts are arranged on both sides of the transmission rod. The gear of the transmission rod meshes with the internal gear ring of the knob to drive the two winding posts to rotate. The end of the bending wire is fixedly connected to the winding post.

7. The adjustable bending medical device according to claim 6, characterized in that, The worm has two intersecting helical lines, and the tooth direction of the worm wheel corresponds to the helical line on the same side. The worm wheels of the two winding columns mesh with the worm and rotate in the same direction.

8. The adjustable bending medical device according to claim 6, characterized in that, The winding post is provided with a winding groove, which is recessed inward along the radial direction of the winding post, and the bending wire is wound in the winding groove.

9. An adjustable bending medical device according to claim 6, characterized in that, The winding post has two worm gears, which are located at both ends of the winding post. The knob has two transmission rods symmetrically arranged in the diameter direction, and the worms of the two transmission rods mesh with the worm gears at one end of the two winding posts respectively.

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