An adjustable bendable sheath system

Abstract

This application relates to the field of medical device technology, specifically disclosing an adjustable bending sheath system. To address the problem of surgeons being forced to change sheaths of different sizes mid-operation, the system includes a handle, a sheath, and a hemostatic valve assembly. The sheath has a fixed section and an adjustable bending section. A first adjusting ring and a second adjusting ring are spaced apart within the adjustable bending section. A first adjusting wire and a second adjusting wire pass through the sheath. The first adjusting wire is connected to the first adjusting ring, and the second adjusting wire is connected to the second adjusting ring. An adjustment component is provided within the handle, comprising a first driving block and a second driving block. The first driving block can pull the first adjusting wire to produce a bend of a first radius of curvature in the adjustable bending section; the second driving block can pull the second adjusting wire to produce a bend of a second radius of curvature in the adjustable bending section. The first and second radii of curvature are different. This application allows for selection of different bending modes based on vascular anatomy without changing the device.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to an adjustable bendable sheath system. Background Technology

[0002] With the rapid development of cardiovascular interventional therapy technology, the procedures are constantly evolving towards greater precision, minimal invasiveness, and adaptation to complex anatomical structures. In the field of cardiac electrophysiology, catheter ablation for arrhythmias such as atrial fibrillation and premature ventricular contractions has become mainstream. However, the cases encountered clinically are becoming increasingly complex. Statistics show that cases involving complex anatomical structures such as severely tortuous pulmonary vein openings, mitral isthmus stenosis, and the Summit region of the heart account for more than 30%. The success of these procedures depends heavily on the stable and precise delivery of interventional devices to the target area. Adjustable bending sheaths, as key channels for guiding ablation catheters, mapping electrodes, or other devices, directly affect the efficiency and safety of the procedure. Through their controllable bending at the distal end, the operator can guide the sheath to conform to the natural course of the heart chambers or blood vessels, providing ideal support and coaxiality for subsequent treatment devices, thereby completing core operations such as precise electrical isolation and ablation.

[0003] Similarly, in the field of peripheral vascular intervention, such as renal denervation (RDN) for refractory hypertension or the use of covered stents to treat aortic dissection, superselective cannulation is often required in tortuous, multi-branched vascular pathways. Adjustable bending sheaths have shown great advantages in such procedures, significantly improving instrument accessibility, making the procedure smoother, and shortening operation time.

[0004] Existing sheaths typically offer only one fixed bending diameter or radius of curvature. However, in a single procedure, the surgeon may need to navigate drastically different anatomical pathways—for example, first through a wide atrial cavity, then into a narrow, sharply angled pulmonary vein vestibule. When the pre-defined single bending diameter cannot perfectly accommodate both scenarios simultaneously, the surgeon is forced to change to a different sheath size mid-procedure. This not only significantly prolongs the procedure and increases medical costs, but also introduces additional risks of vascular injury and contrast agent usage during the exchange process. Summary of the Invention

[0005] In order to reduce the occurrence of long operation time and high medical costs caused by the need to change sheaths of different sizes during the operation, this application provides an adjustable bending sheath system.

[0006] The adjustable bending sheath system provided in this application adopts the following technical solution:

[0007] An adjustable bending sheath system includes a handle, a sheath inserted into the handle, and a hemostatic valve assembly installed near the proximal end of the handle, wherein the sheath has a fixed section and an adjustable bending section.

[0008] The adjustable bending section is provided with a first bending ring and a second bending ring at intervals along the axial direction.

[0009] The sheath is provided with a first bending wire and a second bending wire, the distal end of the first bending wire is fixedly connected to the first bending ring, and the distal end of the second bending wire is fixedly connected to the second bending ring.

[0010] An adjustment assembly is provided inside the handle. The adjustment assembly includes a first drive block and a second drive block that can move along the handle axis. The first drive block is operatively connected to the proximal end of the first bending wire, and the second drive block is operatively connected to the proximal end of the second bending wire.

[0011] Under the traction of the first driving block, the first bending wire causes the adjustable bending segment to bend with a first radius of curvature; under the traction of the second driving block, the second bending wire causes the adjustable bending segment to bend with a second radius of curvature, wherein the first radius of curvature is different from the second radius of curvature.

[0012] Furthermore, the first bending ring is closer to the distal end of the sheath than the second bending ring, and the first radius of curvature is smaller than the second radius of curvature.

[0013] Furthermore, a first bending fixing member is fixedly connected to the proximal end of the first bending wire, and a second bending fixing member is fixedly connected to the proximal end of the second bending wire. Both the first and second bending fixing members are disposed in the inner cavity of the handle. When the first driving block slides in the handle, it can push the first bending fixing member to move toward the proximal end of the handle, and when the second driving block slides in the handle, it can push the second bending fixing member to move toward the proximal end of the handle.

[0014] Furthermore, the adjustment assembly also includes a drive sleeve rotatably connected to the handle, and a first split drive half tube and a second split drive half tube respectively connected to the first drive block and the second drive block.

[0015] The outer wall of the first split drive half tube is provided with a right-hand threaded section, and the outer wall of the second split drive half tube is provided with a left-hand threaded section.

[0016] The inner wall of the drive sleeve is provided with internal threads that mesh with the right-hand threaded section and the left-hand threaded section.

[0017] Rotating the drive sleeve can drive the first split drive half tube and the second split drive half tube to move in opposite directions along the handle axis.

[0018] Furthermore, the adjustment assembly also includes a rotating sleeve sleeved outside the handle and fixedly connected to the drive sleeve.

[0019] Furthermore, the adjustable bending section is a three-layer composite structure comprising an inner layer, a middle layer, and an outer layer;

[0020] The fixed section comprises a four-layer composite structure consisting of an inner layer, a middle layer, a middle reinforcing layer, and an outer layer.

[0021] Furthermore, the weaving density of the intermediate layer of the adjustable bending section is higher than the weaving density of either the intermediate layer or the intermediate reinforcing layer of the fixed section.

[0022] Furthermore, a developing ring is fixed to the distal end of the sheath, and a TIP head with a smooth end face is provided at the distal end of the developing ring.

[0023] Furthermore, the hemostatic valve assembly includes a hemostatic valve body and a side branch interface communicating with the internal channel of the hemostatic valve body. The side branch interface is connected to a three-way valve via a side branch hose.

[0024] Furthermore, a stress-relieving sleeve is fitted onto the proximal end of the sheath at the distal opening of the handle.

[0025] In summary, this application includes at least one of the following beneficial technical effects:

[0026] 1. When it is necessary to bend the distal end of the sheath in one direction, operate the adjustment assembly to move the first drive block axially along the handle. The movement of the first drive block is converted into a traction force on the first bending wire. This traction force is transmitted to the distal end of the first bending wire fixed on the first bending ring, thereby pulling the first bending ring and forcing the adjustable bending segment of the sheath to bend under the traction of the first bending wire, forming a bend with a first radius of curvature. Similarly, operating the second drive block can pull the second bending wire, which acts on the second bending ring, causing the distal end of the sheath to bend under the traction of the second bending wire, forming a bend with a second radius of curvature. This achieves the function of bidirectional and differentiated bending through a single sheath system. The surgeon can select different bending modes (large bend or small bend) according to the vascular anatomy without changing instruments, significantly improving the adaptability and convenience of the operation, and facilitating rapid and accurate access to the target location.

[0027] 2. When the first adjusting wire of the first adjusting ring is pulled, the point of application of the tension is closer to the end of the sheath, and the lever arm is short. Therefore, the radius of curvature generated at the end of the sheath is smaller. When the second adjusting wire of the second adjusting ring is pulled, the point of application of the tension is farther from the end of the sheath, and the lever arm is long. Therefore, the radius of curvature generated is larger.

[0028] 3. By rotating the drive sheath, the reverse movement of the two drive blocks can be precisely and synchronously controlled. The structure is compact and the operation is intuitive. The threaded drive has a self-locking characteristic. When the rotation stops, the position of the drive block is locked, thereby fixing the bending shape of the sheath and preventing accidental straightening inside the body, ensuring surgical safety. The reverse movement naturally realizes the mutually exclusive selection of the two bending modes, with clear logic and avoiding misoperation.

[0029] 4. Through a differentiated layered structural design, the proximal and distal ends of the sheath are endowed with different mechanical properties. The proximal double-layer reinforcement provides extremely high axial pushing stiffness and torsional resistance, ensuring that the pushing, pulling, and rotational forces emitted from the handle can be efficiently and without damage transmitted to the distal end. The distal single-layer reinforcement, while ensuring necessary anti-collapse capability, maximizes flexibility and bendability to adapt to the natural shape of the blood vessel and achieve flexible bending, realizing an ideal combination of strong proximal support and high distal flexibility.

[0030] 5. A flexible stress-relieving sleeve is fitted at the distal opening where the sheath connects to the handle housing, creating a flexible stress transition zone at the root of the sheath. When the distal end of the sheath is repeatedly bent, the alternating stress at the root is absorbed and dispersed by the stress-relieving sleeve, preventing stress concentration at the rigid connection point between the sheath and the handle. This effectively prevents the sheath from breaking at the root due to metal fatigue, greatly extending the product's service life and reliability. Attached Figure Description

[0031] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a schematic diagram of the overall structure of an adjustable bending sheath system according to an embodiment of this application;

[0033] Figure 2 This is a schematic diagram showing the internal structure of the handle according to an embodiment of this application;

[0034] Figure 3 This is an exploded view of the regulating component as shown in an embodiment of this application;

[0035] Figure 4 This is a schematic diagram showing an enlarged cross-section of the adjustable bending section of the sheath in an embodiment of this application;

[0036] Figure 5 This is a schematic diagram showing an enlarged cross-section of the fixed section of the sheath in an embodiment of this application;

[0037] Figure 6 This is a schematic diagram showing the woven mesh structure of the intermediate layer and intermediate reinforcing layer of the sheath in an embodiment of this application;

[0038] Figure 7 This is a schematic diagram showing two bending forms of the sheath in the embodiments of this application;

[0039] Figure 8 This is a schematic diagram of the first bending radius structure of the adjustable bending segment shown in an embodiment of this application;

[0040] Figure 9 This is a schematic diagram showing the second bending radius structure of the adjustable bending segment in an embodiment of this application.

[0041] Explanation of reference numerals in the attached diagram: 1. Handle; 11. Proximal opening; 12. Distal opening; 13. Guide rail; 2. Sheath; 21. Fixed section; 22. Adjustable bending section; 23. Inner layer; 24. Intermediate layer; 25. Intermediate reinforcing layer; 26. Outer layer; 27. Contrast ring; 28. TIP head; 29. ​​Adjustable bending channel; 3. Hemostatic valve assembly; 31. Hemostatic valve body; 32. Side branch interface; 33. Side branch tubing; 34. Three-way valve; 4. Adjustment Components; 41. First drive block; 411. First split drive half-pipe; 412. Right-hand threaded section; 42. Second drive block; 421. Second split drive half-pipe; 422. Left-hand threaded section; 43. Drive sleeve; 44. Rotating sleeve; 51. First bending ring; 52. Second bending ring; 61. First bending screw; 611. First bending fixing piece; 62. Second bending screw; 621. Second bending fixing piece; 7. Stress-relieving sleeve. Detailed Implementation

[0042] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, not all of them. Therefore, the detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to represent selected embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0043] It should be noted that in the field of interventional medical devices, the end of the medical device that is closer to the clinician inside the body is generally called the proximal end, and the end that is farther from the clinician is called the distal end. Based on this principle, the proximal and distal ends of any part of the interventional device are defined. The axial direction generally refers to the length of the medical device, and the radial direction generally refers to the direction perpendicular to the axial direction.

[0044] The following is in conjunction with the appendix Figure 1-9 This application will be described in further detail.

[0045] This application discloses an adjustable bending sheath system, referring to... Figure 1 and Figure 2 It includes a handle 1, a sheath 2, a hemostatic valve assembly 3, and an adjustment assembly 4 integrated inside the handle 1.

[0046] The handle 1 is a cylindrical hollow shell, the main body of which is composed of two symmetrically structured half-shells. The edges of the two half-shells are provided with corresponding connecting structures, such as snap-fit ​​connections, hole-shaft mating connections, or adhesive bonding. In this embodiment, the connecting structure is preferably a snap-fit ​​or hole-shaft mating, which facilitates the assembly of the handle 1. The handle 1 has an octagonal cross-section, and its ergonomic design makes it more comfortable for the operator to hold, while also allowing the handle 1 to be placed horizontally on a table without easily rolling.

[0047] Reference Figure 2 and Figure 3 The handle 1 has a proximal opening 11 and a distal opening 12 at its two ends. The sheath 2 is inserted into the inner cavity of the handle 1. One end of the sheath 2 is fixed inside the handle 1, and the other end of the sheath 2 extends to the outside through the distal opening 12 of the handle 1, forming a through vascular intervention channel. The sheath 2 is divided into an adjustable bending section 22 and a fixed section 21 along its length.

[0048] Reference Figure 4 The adjustable bending section 22 adopts a three-layer composite structure, which includes an inner layer 23, a middle layer 24 and an outer layer 26 from the inside to the outside.

[0049] The inner layer 23 is made of medical-grade low-friction polymer material, preferably polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP) or modified polyolefin, forming a smooth inner cavity channel, which can reduce the frictional resistance when interventional instruments pass through and reduce wear on the instrument surface.

[0050] Reference Figure 4 and Figure 6 The intermediate layer 24 is sandwiched between the inner layer 23 and the outer layer 26. The intermediate layer 24 uses a metal wire or high-strength fiber woven mesh structure, which enhances the torsional resistance and structural strength of the sheath 2, preventing collapse or excessive deformation during bending or pushing. The braided mesh structure at the distal adjustable bending end has a braided PPI of 20-50; in this embodiment, a braided PPI of 38 is preferred. High-density braiding provides more uniform mesh support, better resisting radial compression when the sheath 2 bends, effectively preventing lumen collapse and ensuring the interventional device channel remains unobstructed. Simultaneously, sufficient density also ensures torque transmission.

[0051] The outer layer 26 is the outer surface layer of the sheath 2, which wraps around and fixes the middle layer 24 and the inner layer 23. It is made of flexible materials such as medical-grade polyurethane (PU), nylon 12 or polyether block polyamide (PEBAX), which have good biocompatibility and flexibility and can adapt to the natural direction of blood vessels.

[0052] Reference Figure 5 and Figure 6 The fixed section 21 adopts a four-layer composite structure, which includes an inner layer 23, a middle layer 24, a middle reinforcing layer 25 and an outer layer 26 from the inside to the outside. The inner layer 23 and the outer layer 26 use the same structure and materials. The middle layer 24 and the middle reinforcing layer 25 are both woven mesh structures. The difference between the middle layer 24 of the adjustable bending section 22 and the middle layer 25 of the fixed section 21 is that the woven PPI of the middle layer 24 and the middle reinforcing layer 25 is 10-45. In this embodiment, the preferred woven PPI is 15.

[0053] The fixed section 21 has a lower weave density, making the single-layer mesh structure relatively flexible. However, through double-layer stacking, its overall strength far exceeds that of a single-layer high-density structure, thus achieving the ultra-high rigidity required at the proximal end without excessively increasing wall thickness and stiffness. The double-woven mesh structure provides strong axial pushing force and torsional stiffness, ensuring that the pushing, pulling, and rotational movements applied by the doctor at the proximal end can be efficiently and without damage transmitted to the distal end. At the same time, the adjustable bending section 22 maintains the flexibility of the single-layer mesh structure, thus achieving an ideal performance combination of strong proximal support and high distal flexibility.

[0054] Reference Figure 6 The distal end of the sheath 2 is fixed with a radiopaque ring 27. The radiopaque ring 27 is made of high-density radiopaque metal material, preferably platinum-iridium alloy, gold-palladium alloy or tantalum. Its fixing method can be selected according to actual needs: it can be bonded to the inner layer 23 of the sheath 2 with medical special adhesive, or it can be connected to the metal wire of the intermediate reinforcing layer 25 by laser welding or resistance welding. Then it is heat-fused with the outer layer 26 to finally achieve coaxial fit and fixation between the radiopaque ring 27 and the sheath 2, ensuring no relative slippage during use and ensuring the accuracy of intraoperative imaging positioning.

[0055] Reference Figure 6 The distal end of the imaging ring 27 is provided with a TIP head 28. The end face of the TIP head 28 is smoothly transitioned and the edges are without sharp corners, which can effectively reduce the risk of scratching the inner wall of the blood vessel during the intervention and improve the safety of the operation.

[0056] Reference Figure 5 and Figure 6The adjustable bend section 22 of the sheath 2 is provided with a first adjusting ring 51 and a second adjusting ring 52. The first adjusting ring 51 is located between the second adjusting ring 52 and the developing ring 27. Both are circular ring structures and are coaxially installed between the inner layer 23 and the intermediate layer 24. Two symmetrical adjusting cavities 29 are also provided between the inner layer 23 and the intermediate layer 24. The two adjusting cavities 29 are evenly distributed with the central axis of the sheath 2 as the center of symmetry and pass through the adjustable bend section 22 and the fixed section 21 along the length of the sheath 2.

[0057] A first bending wire 61 and a second bending wire 62 are respectively inserted into the two bending cavities 29. The ends of the first bending ring 51 and the second bending ring 52 are respectively provided with fixing grooves that are adapted to the bending wires. The distal end of the first bending wire 61 is inserted into the groove of the first bending ring 51 and fixed by interference fit or laser spot welding. The distal end of the second bending wire 62 is inserted into the groove of the second bending ring 52 to complete the fixing.

[0058] Reference Figure 7 and Figure 8 When the first bending wire 61 is pulled, the first bending wire 61 will pull the first bending ring 51. Since the first bending wire 61 is located on one side of the first bending ring 51, the first bending ring 51 will shift towards the direction of the first bending wire 61, thereby causing the end of the sheath tube 2 to bend towards the direction of the first bending wire 61 until the adjustable bending section 22 forms a bending line with the first radius of curvature.

[0059] Reference Figure 7 and Figure 9 When the second bending wire 62 is pulled, the second bending wire 62 will pull the second bending ring 52. Since the second bending wire 62 and the first bending wire 61 are located on both sides of the sheath tube 2, the end of the sheath tube 2 will bend in the direction away from the first bending wire 61 until the adjustable bending section 22 forms a bending line with the second radius of curvature.

[0060] Reference Figure 8 and Figure 9 Because the first bending ring 51 is close to the developing ring 27, the point of application of the tension is closer to the end of the sheath tube 2, and the lever arm is short. On the other hand, the second bending ring 52 is farther from the end of the sheath tube 2, and the lever arm is longer. When the first bending wire 61 and the second bending wire 62 move the same distance, the first radius of curvature of the adjustable bending section 22 is smaller than the second radius of curvature.

[0061] Existing adjustable sheaths are mostly designed with bidirectional equal-diameter bends or unidirectional bends, which cannot match the differences in anatomical curvature of different target sites (such as the small curvature bends of cardiovascular branches and the large curvature tortuous paths of peripheral vessels). This application achieves bidirectional differentiated bending of 10mm~20mm (small bending diameter) and 20mm~55mm (large bending diameter) by adding "dual-ring bending components (first bending component and second bending component)" and "dual-path independent transmission wire drawing". The small bending diameter can accurately adapt to narrow vessels and small-sized anatomical structures (such as the scenario where the anteroposterior diameter of the left atrium is ≤45mm in left atrial appendage occlusion), while the large bending diameter can adapt to wide vessels and large curvature paths (such as the scenario where the anteroposterior diameter of the left atrium is 45~55mm). This avoids the positioning deviation caused by "the inability of a single diameter to accurately fit the anatomical structure" in existing technologies, and makes the device delivery channel highly consistent with the natural direction of the blood vessel.

[0062] Reference Figure 2 and Figure 3 Two symmetrically arranged wire-threading holes are provided on the outer wall of the sheath tube 2 located inside the handle 1. The proximal ends of the first bending wire 61 and the second bending wire 62 pass through the corresponding wire-threading holes and exit the sheath tube 2. The proximal end of the first bending wire 61 is fixedly connected to the first bending fixing member 611, and the proximal end of the second bending wire 62 is fixedly connected to the second bending fixing member 621. The tension of the bending wire is transmitted to the adjustment component 4 through the fixing members.

[0063] The adjustment assembly 4 includes a first drive block 41 and a second drive block 42 slidably disposed in the inner cavity of the handle 1. Two parallel guide rails 13 are fixedly connected to the bottom of the inner cavity of the handle 1. The bottom of the first drive block 41 and the second drive block 42 are provided with limiting grooves that are adapted to the guide rails 13. The limiting grooves are engaged with the guide rails 13 to restrict the first drive block 41 and the second drive block 42 to move linearly only along the length of the rail, thereby preventing circumferential rotation during the movement and ensuring the stability of the bending operation.

[0064] The first drive block 41 is fixedly connected to the far end of the first split drive half tube 411, and the second drive block 42 is fixedly connected to the far end of the second split drive half tube 421. Both split drive half tubes are formed by axially cutting cylindrical hollow tubes along the plane containing their axes. The axial cutting planes of the two tubes can fit together to form a complete cylindrical sleeve. The sleeve is coaxially fitted on the outside of the proximal end of the sheath tube 2 and does not affect the normal function of the sheath tube 2.

[0065] Reference Figure 2 and Figure 3The outer wall of the first split drive half-tube 411 is integrally formed with a right-hand threaded section 412, and the outer wall of the second split drive half-tube 421 is integrally formed with a left-hand threaded section 422. The specifications of the two threaded sections are the same, only the direction of rotation is opposite. A drive sleeve 43 is fitted on the outside of both split drive half-tubes. The drive sleeve 43 is rotatably engaged with the inner cavity of the handle 1 through a bearing. The inner wall of the drive sleeve 43 is machined with two sets of internal threads that are adapted to the right-hand threaded section 412 and the left-hand threaded section 422, respectively. The two sets of internal threads precisely mesh with the external threads of the corresponding drive half-tubes. When the drive sleeve 43 rotates around its own axis, through the meshing transmission action of the reverse threads, it can synchronously drive the first split drive half-tube 411 and the second split drive half-tube 421 to move in opposite linear directions along the axis of the sheath tube 2, either moving away from or closer to each other, thereby driving the first drive block 41 and the second drive block 42 to move synchronously in opposite directions. Based on the static analysis of inclined plane friction, self-locking can be achieved when p < πμd² (p: pitch; μ: maximum static friction coefficient of the material; d²: thread pitch diameter). The pitch and thread diameter of the two split drive half-pipes and drive sleeve 43 are calculated to achieve suspension at any angle, making the bending effect more precise. This allows the operator to free up their hands to use other instruments when adjusting to a satisfactory angle, reducing the difficulty of operation.

[0066] Turning the drive sleeve 43 counterclockwise causes the first split drive half-tube 411 to move toward the first bending fixing member 611, and the second drive half-tube to move away from the second bending fixing member 621. The first drive block 41 contacts the first bending fixing member 611 and pushes the first bending fixing member 611 toward the proximal opening 11. When the first bending fixing member 611 moves, it pulls the first bending wire 61 toward the proximal opening 11. The first bending wire 61 pulls the first adjusting ring, thereby causing the adjustable bending section 22 to bend toward one side of the first bending wire 61 until the adjustable bending section 22 forms a bending line with a first radius of curvature.

[0067] When the drive sleeve 43 is turned clockwise, the drive sleeve 43 drives the first split drive half tube 411 to move away from the first bending fixing member 611, thereby removing the tension on the first bending screw 61, and the adjustable bending section 22 gradually returns to its original state.

[0068] Simultaneously, the second drive half-tube moves toward the direction of the second bending fixing member 621, the second drive block 42 contacts the second bending fixing member 621 and pushes the second bending fixing member 621 toward the direction of the proximal opening 11. When the second bending fixing member 621 moves, it will pull the second bending wire 62 toward the direction of the proximal opening 11. The second bending wire 62 pulls the second bending ring 52, so that the adjustable bending section 22 bends toward one side of the second bending wire 62 until the adjustable bending section 22 forms a bending line with the second radius of curvature.

[0069] Since the first adjusting wire 61 and the second adjusting wire 62 are respectively located on both sides of the sheath 2, the bending directions of the two bending lines are opposite. Furthermore, because the first adjusting ring 51 and the second adjusting ring 52 are positioned differently in the axial section of the sheath 2, the bending radii of the resulting bending lines are also different. By rotating the drive sleeve 43, the reverse movement of the two drive blocks can be precisely and synchronously controlled. The structure is compact, the operation is intuitive, and the threaded drive has a self-locking characteristic. When rotation stops, the position of the drive block is locked, thereby fixing the bending shape of the sheath 2, preventing accidental straightening within the body, and ensuring surgical safety. The reverse movement naturally achieves the mutually exclusive selection of the two bending modes, with clear logic, avoiding misoperation.

[0070] The single sheath system allows for bidirectional, differentiated bending. Surgeons can select different bending patterns based on vascular anatomy without changing instruments, significantly improving surgical adaptability and ease of operation, and facilitating rapid and precise target acquisition.

[0071] Reference Figure 2 and Figure 3 The handle 1 is fitted with a rotating sleeve 44. The rotating sleeve 44 is coaxially arranged and fixedly connected to the drive sleeve 43. The outer wall of the rotating sleeve 44 is provided with anti-slip texture, which makes it easy for the operator to hold and rotate. The rotating sleeve 44 can drive the drive sleeve 43 to rotate synchronously, so as to realize convenient control of the bending operation.

[0072] Reference Figure 3 The distal end of the sheath tube 2 is also fitted with a stress-relieving sleeve 7, which is fixed at the distal opening 12 of the handle 1. It is used to eliminate stress concentration at the connection between the sheath tube 2 and the handle 1, and to prevent the sheath tube 2 from fatigue fracture due to stress accumulation during repeated bending, thereby extending the service life of the sheath tube 2.

[0073] Reference Figure 1 and Figure 2 The hemostatic valve assembly 3 includes a hemostatic valve body 31, which is inserted into the proximal opening 11 of the handle 1 and fixed to the inner cavity of the handle 1 through a snap-fit ​​structure. The proximal end of the sheath 2 located in the handle 1 is sealed to the hemostatic valve body 31, which not only achieves the fixed limit of the proximal end of the sheath 2, but also ensures the communication between the inner cavity of the sheath 2 and the internal channel of the hemostatic valve body 31, effectively preventing blood leakage during the operation.

[0074] The hemostatic valve body 31 has an integrally formed side branch interface 32 on its exterior. The inner channel of the side branch interface 32 is connected to the inner channel of the hemostatic valve body 31. The side branch interface 32 is fixedly connected to the three-way valve 34 through the side branch hose 33. The three-way valve 34 can switch the internal channel to realize operations such as infusion, drug administration and pressure detection, without the need for frequent insertion and removal of instruments. This can optimize the surgical procedure, reduce the risk of infection and significantly shorten the operation time.

[0075] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An adjustable bending sheath system, comprising a handle (1), a sheath (2) inserted into the handle (1), and a hemostatic valve assembly (3) installed at the proximal end of the handle (1), the sheath (2) having a fixed section (21) and an adjustable bending section (22), characterized in that: The adjustable bending section (22) is provided with a first bending ring (51) and a second bending ring (52) spaced apart along the axial direction. The sheath (2) is provided with a first bending wire (61) and a second bending wire (62). The distal end of the first bending wire (61) is fixedly connected to the first bending ring (51), and the distal end of the second bending wire (62) is fixedly connected to the second bending ring (52). An adjustment assembly (4) is provided inside the handle (1). The adjustment assembly (4) includes a first drive block (41) and a second drive block (42) that can move along the axial direction of the handle (1). The first drive block (41) is operatively connected to the proximal end of the first bending wire (61), and the second drive block (42) is operatively connected to the proximal end of the second bending wire (62). Under the traction of the first driving block (41), the first bending wire (61) drives the adjustable bending section (22) to bend with a first radius of curvature; under the traction of the second driving block (42), the second bending wire (62) drives the adjustable bending section (22) to bend with a second radius of curvature, and the first radius of curvature is different from the second radius of curvature. The first bending ring (51) is closer to the distal end of the sheath (2) than the second bending ring (52), and the first radius of curvature is smaller than the second radius of curvature; The adjustment assembly (4) further includes a drive sleeve (43) rotatably connected to the handle (1), and a first split drive half tube (411) and a second split drive half tube (421) respectively connected to the first drive block (41) and the second drive block (42). The outer wall of the first split drive half tube (411) is provided with a right-hand thread section (412), and the outer wall of the second split drive half tube (421) is provided with a left-hand thread section (422). The inner wall of the drive sleeve (43) is provided with an internal thread that meshes with the right-hand threaded section (412) and the left-hand threaded section (422); Rotating the drive sleeve (43) can drive the first split drive half tube (411) and the second split drive half tube (421) to move in opposite directions along the handle (1) axis.

2. The adjustable bending sheath system according to claim 1, characterized in that, The first bending wire (61) is fixedly connected to the proximal end of the first bending wire (61) with a first bending fixing member (611), and the second bending wire (62) is fixedly connected to the proximal end of the second bending wire (62). The first bending fixing member (611) and the second bending fixing member (621) are both disposed in the inner cavity of the handle (1). When the first driving block (41) slides in the handle (1), it can push the first bending fixing member (611) to move toward the proximal end of the handle (1). When the second driving block (42) slides in the handle (1), it can push the second bending fixing member (621) to move toward the proximal end of the handle (1).

3. The adjustable bending sheath system according to claim 2, characterized in that, The adjustment assembly (4) also includes a rotating sleeve (44) sleeved outside the handle (1) and fixedly connected to the drive sleeve (43).

4. The adjustable bending sheath system according to claim 1, characterized in that, The adjustable bending section (22) is a three-layer composite structure including an inner layer (23), a middle layer (24) and an outer layer (26); The fixed section (21) is a four-layer composite structure comprising an inner layer (23), a middle layer (24), a middle reinforcing layer (25), and an outer layer (26).

5. An adjustable bending sheath system according to claim 4, characterized in that, The weaving density of the intermediate layer (24) of the adjustable bending section (22) is higher than that of either the intermediate layer (24) or the intermediate reinforcing layer (25) of the fixed section (21).

6. The adjustable bending sheath system according to claim 1, characterized in that, The distal end of the sheath (2) is fixed with a developing ring (27), and the distal end of the developing ring (27) is provided with a TIP head (28) with a smooth end face transition.

7. The adjustable bending sheath system according to claim 1, characterized in that, The hemostatic valve assembly (3) includes a hemostatic valve body (31) and a side branch interface (32) communicating with the internal channel of the hemostatic valve body (31). The side branch interface (32) is connected to a three-way valve (34) via a side branch hose (33).

8. An adjustable bending sheath system according to claim 1, characterized in that, The proximal end of the sheath (2) is fitted with a stress-relieving sleeve (7) at the distal opening (12) of the handle (1).

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