Adjustable deflectable sheath

Abstract

The present invention relates to an adjustable bending sheath, which comprises a sheath tube and a pull wire. The pull wire includes a main trunk and a plurality of branches connected to the main trunk. The proximal ends of the plurality of branches all extend towards the proximal end. The plurality of branches each include a wire body portion slidably embedded in the tube wall of the main body tube, and the wire body portions of the plurality of branches all extend axially. The plurality of branches include at least one wire group formed by two of the branches. The range of the angle by which the wire body portions of the two branches of the wire group are circumferentially spaced is [60°, 180°]. Moreover, the wire body portion of one branch of the wire group is circumferentially located on one side of the main trunk, and the wire body portion of the other branch of the wire group is circumferentially located on the other side of the main trunk, or the angle by which the wire body portion of the other branch of the wire group is circumferentially spaced from the main trunk is 0°. The positioning of the sheath tube of the adjustable bending sheath of the present invention is less difficult.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an adjustable bending sheath. Background Art

[0002] The information provided in this section is only background information related to the present disclosure, and it is not necessarily prior art.

[0003] In endovascular therapy surgeries, an adjustable bending sheath can be used to establish a delivery channel from inside the body to the outside, so as to facilitate the doctor to deliver interventional or implantable devices to the target position.

[0004] When the target position is on the large curvature side of the body cavity (such as the brachiocephalic artery, left common carotid artery or left subclavian artery on the large curvature side of the aortic arch), the doctor first pushes the nozzle of the sheath tube of the adjustable bending sheath to the aortic arch, and then bends the adjustable bending part of the sheath tube and keeps the adjustable bending part in the bent shape. Then an operating torque is applied to the sheath tube to adjust the circumferential position of the sheath tube, so that the nozzle of the sheath tube can be aligned with the target position. However, when adjusting the circumferential position of the nozzle of the sheath tube, it is difficult for the doctor to position the sheath tube so that the nozzle of the sheath tube is aligned with the target position. Summary of the Invention

[0005] Based on this, it is necessary to provide an adjustable bending sheath that can reduce the positioning difficulty of the sheath tube.

[0006] An adjustable bending sheath includes a sheath tube and a wire. The sheath tube includes an adjustable bending tube and a main body tube. The proximal end of the adjustable bending tube is connected to the distal end of the main body tube. The wire includes:

[0007] A main trunk, which is slidably embedded in the tube wall of the adjustable bending tube. The distal end of the main trunk is connected to the distal end of the adjustable bending tube, and the proximal end of the main trunk extends axially.

[0008] Multiple branches, the distal ends of the multiple branches are all connected to the proximal end of the main trunk. The proximal ends of the multiple branches all extend proximally, and the proximal ends of the multiple branches all extend to the outside of the sheath tube. The multiple branches all include wire body parts that are slidably embedded in the tube wall of the main body tube, and the wire body parts of the multiple branches all extend axially. The multiple branches include at least one wire group formed by two of the branches. The range of the angle between the wire body parts of the two branches in the wire group in the circumferential direction is [60°, 180°], and,

[0009] The wire body part of one branch in the wire group is on one side of the main trunk in the circumferential direction, and the wire body part of the other branch in the wire group is on the other side of the main trunk in the circumferential direction, or the angle between the wire body part of the other branch in the wire group and the main trunk in the circumferential direction is 0°.

[0010] During the use of the adjustable bending sheath provided by the embodiment of the present invention, first, a pulling force is applied to the proximal ends of multiple branches to cause the adjustable bending tube to bend and deform. After the bending adjustment is completed, the magnitude of the pulling force applied to the proximal ends of the multiple branches is locked to keep the adjustable bending tube in the bent shape. Then, the sheath tube is twisted to adjust the circumferential position of the orifice of the adjustable bending tube.

[0011] During the twisting process of the sheath tube, when the angle between the main trunk and the center line of the large curvature side of the aortic arch in the circumferential direction is within the value range of (0°, 30°), the two branches of the wire group are respectively located on both sides of the center line of the large curvature side of the aortic arch, and the directions of the pulling wire torques of the two branches of the wire group are opposite. Therefore, the pulling wire torques of the two branches of the wire group at least cancel each other out partially, so that the magnitude of the combined torque of the pulling wires of the multiple branches is reduced. Therefore, it is possible to reduce the interference formed by the multiple branches to the operator during the twisting process of the sheath tube, which is beneficial to reducing the difficulty of sheath tube positioning. Description of the Drawings

[0012] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0013] Among them:

[0014] Figure 1 is a schematic structural diagram of a bent tubular structure in the prior art;

[0015] Figure 2 is Figure 1 a sectional view along I – I;

[0016] Figure 3 is a sectional view of the sheath tube of the adjustable bending sheath in the prior art;

[0017] Figure 4 is a state diagram during the use of the adjustable bending sheath in the prior art;

[0018] Figure 5 is a sectional view of the sheath tube and the aortic arch after the adjustable bending sheath completes the bending adjustment during the use of the adjustable bending sheath in the prior art;

[0019] Figure 6 is a sectional view of the sheath tube and the aortic arch when the pulling wire is twisted to an angle of 0° in the circumferential direction from the center line of the large curvature side of the aortic arch during the use of the adjustable bending sheath in the prior art;

[0020] Figure 7ADuring the use of an adjustable bending sheath in the prior art, it is a torque analysis diagram of the traction wire when the traction wire approaches the center line of the large curvature side of the aortic arch along the W direction and does not cross the center line of the large curvature side of the aortic arch;

[0021] Figure 7B During the use of an adjustable bending sheath in the prior art, it is a torque analysis diagram of the traction wire when the traction wire approaches the center line of the large curvature side of the aortic arch along the W direction and crosses the center line of the large curvature side of the aortic arch;

[0022] Figure 8 It is a three-dimensional view of an adjustable bending sheath according to an embodiment;

[0023] Figure 9 It is a three-dimensional view of an adjustable bending sheath according to an embodiment from another perspective after hiding the knob;

[0024] Figure 10 It is a cross-sectional view of the sheath tube of an adjustable bending sheath according to an embodiment;

[0025] Figure 11 It is a schematic structural diagram of the sheath tube, the pull wire and the sliding member of an adjustable bending sheath according to an embodiment;

[0026] Figure 12 It is Figure 11 the left view of;

[0027] Figure 13 It is a state diagram of an adjustable bending sheath according to an embodiment during use when the angle between the main body and the center line of the small curvature side of the aortic arch in the circumferential direction is 0°;

[0028] Figure 14 It is a state diagram of an adjustable bending sheath according to an embodiment during use when the angle between the main body and the center line of the large curvature side of the aortic arch in the circumferential direction is less than 90°;

[0029] Figure 15 It is an adjustable bending sheath according to an embodiment in Figure 14 the state shown in the torque analysis diagram;

[0030] Figure 16 It is a state diagram of an adjustable bending sheath according to an embodiment during use when the main body is rotated to cross the center line of the large curvature side of the aortic arch and the angle between the main body and the center line of the large curvature side of the aortic arch in the circumferential direction is less than 90°;

[0031] Figure 17 It is a schematic structural diagram of a wire group according to another embodiment;

[0032] Figure 18 It is Figure 17 a schematic structural diagram of the sheath tube, the pull wire and the sliding member of the adjustable bending sheath shown in the embodiment;

[0033] Figure 19A is Figure 17 the left view of;

[0034] Figure 19B is Figure 19A the enlarged view of O in;

[0035] Figure 20A is the schematic structural view of the sheath tube, the wire and the slider of the adjustable bending sheath of another embodiment;

[0036] Figure 20B is Figure 20A the enlarged view of P in;

[0037] Figure 21 is Figure 20A the left view of;

[0038] Figure 22A is the schematic structural view of the sheath tube, the wire and the slider of the adjustable bending sheath of another embodiment;

[0039] Figure 22B is the schematic structural view of the slider, the balance bracket and the branch of the embodiment shown in Fig. 22;

[0040] Figure 23 is Figure 22A the left view of. Detailed implementation manners

[0041] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0042] In the description of the embodiments of the present invention, it should be noted that the orientation or positional relationship indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the embodiments of the present invention. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0043] In the description of the embodiments of the present invention, it should be noted that, unless otherwise clearly specified and defined, the terms "installation", "connection", and "coupling" should be understood in a broad sense. For example, it may be a fixed connection, a replaceable connection, or an integral connection; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium; it may be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific situations.

[0044] In the field of interventional medical devices, generally, the end of a medical device implanted into the human body or animal body that is closer to the operator is called the "proximal end", and the end that is farther from the operator is called the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined based on this principle. The "axial direction" generally refers to the length direction of the medical device when it is being delivered, and the "radial direction" generally refers to the direction of the medical device that is not parallel to its "axial direction", and the "axial direction" and "radial direction" of any component of the medical device are defined based on this principle. The "circumferential direction" refers to the circumferential direction, that is, the direction around the axis of the lumen structure or cylinder.

[0045] In order to explain the meanings of the greater curvature side region, the greater curvature side center line, the lesser curvature side region, and the lesser curvature side center line, a curved tubular structure is used as an example in this paragraph. Please refer to Figure 1 and Figure 2 , the tubular structure 100A is a section of curved tube body, which includes a greater curvature side region 10A and a lesser curvature side region 20A in the circumferential direction. Both the greater curvature side region 10A and the lesser curvature side region 20A extend 180° along the circumferential direction. In the circumferential direction, the greater curvature side region 10A and the lesser curvature side region 20A have two dividing lines L1. The greater curvature side region 10A has a greater curvature side center line 110A, and the region included in the greater curvature side region 10A is the region starting from the greater curvature side center line 110A and extending 90° along the circumferential direction to both sides respectively. The lesser curvature side region 20A has a lesser curvature side center line 210A, and the region included in the lesser curvature side region 20A is the region starting from the lesser curvature side center line 210A and extending 90° along the circumferential direction to both sides respectively. The greater curvature side center line 110A and the lesser curvature side center line 210A are radially opposite and located in the same plane. It should be noted that in Figure 2 the cross-sectional view of the tubular structure 10A shown, four dot-like structures are respectively used to indicate the circumferential positions of the greater curvature side center line 110A, the lesser curvature side center line 210A, and the two dividing lines L1 on the tubular structure 10A.

[0046] Please refer to Figure 3The existing adjustable bending sheath 100B includes a sheath tube 10B and a traction wire 30B. The traction wire 30B extends axially within the tube wall of the sheath tube 10B. The distal end of the traction wire 30B is connected to the distal end of the sheath tube 10B, and the proximal end extends to the vicinity of the proximal end of the sheath tube 10B and then extends to the outside of the sheath tube 10B. The traction wire 30B is a monofilament. Under the action of tension, the traction wire 30B applies tension to the distal end of the sheath tube 10B on one side of the sheath tube 10B, thereby causing the sheath tube 10B to bend and deform toward the side where the traction wire 30B is located. After the sheath tube 10B is bent, the traction wire 30B is located in the small bend side area of the sheath tube 10B, and the position of the traction wire 30B is the position where the center line of the small bend side of the sheath tube 10B is located.

[0047] See also Figure 4 , taking the target position as the brachiocephalic artery near the center line S2 of the greater curvature of the aortic arch as an example, the use process of the adjustable bending sheath is described. During use, the operator first pushes the distal end of the sheath 10B to the position of the aortic arch close to the brachiocephalic artery, and then applies a pulling force directed to the proximal end to the traction wire 30B, so that the sheath 10B is bent and deformed toward one side of the traction wire 30B (i.e., the sheath 10B is adjusted to bend). After the sheath 10B is bent and deformed, the tube mouth faces the center S1 of the lesser curvature of the aortic arch. The operator locks the position of the proximal end of the traction wire 30B to keep the sheath 10B at Figure 4 The curved shape shown, and the bending angle remains unchanged.

[0048] Then, a torque is applied to the sheath tube 10B so that the sheath tube 10B moves along Figure 4 The W direction is rotated in order to move the tube opening of the sheath tube 10B from Figure 4 The center line S1 on the lesser curvature of the aortic arch, as shown by the solid line, twists to Figure 4 The tube opening shown by the middle dotted line is oriented toward the centerline S2 of the greater curvature of the aortic arch (i.e., the tube opening of the sheath tube 10B is aligned with the target position of the brachiocephalic artery of the centerline S2 of the greater curvature of the aortic arch). Figure 4 The side shown by the solid line is twisted to the other side shown by the dotted line which is radially opposite to the solid line. The torque applied by the operator is hereinafter referred to as "operating torque".

[0049] During the twisting process of the sheath tube 10B, the operator has difficulty positioning the orifice of the sheath tube 10B in alignment with the brachiocephalic artery near the centerline S2 of the greater curvature of the aortic arch. During the twisting process, either the applied operating torque is too small, preventing the orifice from rotating toward the centerline S2 of the greater curvature of the aortic arch, or the applied operating torque is too large, causing the orifice to not be stopped promptly after rotating toward the centerline S2 of the greater curvature of the aortic arch (i.e., locking the circumferential position of the sheath tube 10B). The sheath tube 10B rotates one full circle and returns to its initial circumferential position (i.e., the orifice returns to a position radially aligned with the centerline S1 of the lesser curvature of the aortic arch).

[0050] Regarding the reason for this defect, after creative work, the inventors of the present invention determined that during the process of the operator applying a pulling force to the sheath tube 10B through the pulling wire 30B to bend the sheath tube 10B, when the pulling wire 30B is subjected to the pulling force, the pulling wire 30B itself will generate a tension to counteract the pulling force. The tension of the pulling wire 30B is positively correlated with the amplitude of the stretching of the pulling wire 30B. When the amplitude of the stretching of the pulling wire 30B is larger, the tension of the pulling wire 30B is larger; conversely, the tension of the pulling wire 30B is smaller.

[0051] Since the part of the sheath tube 10B located in the aortic arch has a curved shape and the sheath tube 10B needs to adapt to the shape of the blood vessel, the angle between the center line of the small bend side of the sheath tube 10B and the center line S1 of the small bend side of the aortic arch in the circumferential direction is basically 0°, and the angle between the center line of the large bend side of the sheath tube 10B and the center line S2 of the large bend side of the aortic arch in the circumferential direction is basically 0°. During the process of the operator twisting the sheath tube 10B, the pulling wire 30B is Figure 4 twisted from the side shown by the solid line in the figure to the other side shown by the dotted line radially opposite to the solid line. The circumferential position of the sheath tube 10B at the pulling wire 30B changes from Figure 5 the pulling wire 30B shown in the figure having a 0° circumferential interval from the center line S1 of the small bend side of the aortic arch to Figure 6 the one shown in the figure having a 0° circumferential interval from the center line S2 of the large bend side of the aortic arch, that is, the pulling wire 30B rotates 180° in the circumferential direction. During this process, as the circumferential rotation angle of the sheath tube 10B gradually increases, the length of the tube body of the sheath tube 10B at the pulling wire 30B gradually increases. Since the positions of both ends of the pulling wire 30B are locked, as the length of the tube body at the pulling wire 30 increases, the length of the tube body at this position will apply a pulling force to both ends of the pulling wire 30, so that the stretching amplitude of the pulling wire 30B increases, resulting in an increase in the tension of the pulling wire 30B.

[0052] That is to say, under the condition that other conditions are the same, the smaller the angle between the traction wire 30B and the center line S2 of the large curvature side of the aortic arch in the circumferential direction, the longer the length of the traction wire 30B stretched, and the greater the tension of the traction wire 30B; the closer the traction wire 30B is to the center line S1 of the small curvature side of the aortic arch in the circumferential direction, the shorter the length of the traction wire 30B, and the smaller the tension of the traction wire 30B. Therefore, when the angle between the traction wire 30B and the center line S1 of the small curvature side of the aortic arch in the circumferential direction is not equal to 0°, the tension of the traction wire 30B will increase to form a tension increment (the magnitude of this tension increment is equal to the magnitude of the tension of the traction wire 30B at this position minus the magnitude of the tension of the traction wire 30B when the circumferential position of the traction wire 30B and the center line S1 of the small curvature side of the aortic arch in the circumferential direction is 0°). When the angle between the traction wire 30B and the center line S2 of the large curvature side of the aortic arch in the circumferential direction is smaller, the tension increment of the traction wire 30B is greater. And when the angle between the traction wire 30B and the center line S2 of the large curvature side of the aortic arch in the circumferential direction is 0°, the tension increment of the traction wire 30B is the largest.

[0053] Since when the sheath tube 10B rotates relative to the aortic arch in the circumferential direction, the shape of a part of the tube body of the sheath tube 10B is always a curved shape, during the rotation of the sheath tube 10B, the tension increment of the traction wire 30B will generate a circumferential torque, and this torque acts on the sheath tube 10B to make the sheath tube 10B rotate in the circumferential direction, so that the angle between the traction wire 30B and the center line S1 of the small curvature side of the aortic arch in the circumferential direction becomes 0°. That is to say, in the absence of external interference, the angle between the traction wire 30B and the center line S1 of the small curvature side of the aortic arch in the circumferential direction is always 0°. To distinguish it from the operating torque, in the following text, the torque formed by the tension increment of the traction wire 30B is expressed as "traction wire torque".

[0054] Among them, the discussion on the magnitude of the traction wire torque is as follows:

[0055] As can be known from the previous content, the magnitude of the traction wire torque is related to the stretching amplitude of the traction wire 30B, that is, related to the circumferential position of the traction wire 30B. Specifically, when the angle between the traction wire 30B and the center line S2 of the large curvature side of the aortic arch in the circumferential direction is smaller, the value of the traction wire torque is greater. When the angle between the traction wire 30B and the center line S2 of the large curvature side of the aortic arch in the circumferential direction is 0°, the value of the traction wire torque is the largest. Correspondingly, when the angle between the traction wire 30B and the center line S1 of the small curvature side of the aortic arch in the circumferential direction is smaller, the value of the traction wire torque is smaller. When the angle between the traction wire 30B and the center line S1 of the small curvature side of the aortic arch in the circumferential direction is 0°, the value of the traction wire torque is zero.

[0056] The discussion on the direction of the traction wire torque is as follows:

[0057] The direction of the traction wire torque is also related to the circumferential position of the traction wire. Specifically, the action of the traction wire torque is always to drive the sheath 10B to rotate so that the traction wire returns to a position where the circumferential interval from the center line S1 of the minor curvature side of the aortic arch is 0°. As Figure 7A shown, during the process of the traction wire 30B approaching the center line S2 of the major curvature side, the direction of the traction wire torque T of the traction wire 30B is Figure 7A the clockwise direction opposite to the W direction shown in, which hinders the operator from twisting the sheath 10B along the W direction. As Figure 7B shown, after the traction wire 30B rotates along the W direction and crosses the center line S2 of the major curvature side of the aortic arch, the direction of the traction wire torque T of the traction wire 30B becomes Figure 7B the counterclockwise direction the same as the W direction shown in, and the traction wire torque T acts on the sheath 10B, having the effect of driving or accelerating the sheath 10B to rotate along the W direction so that the traction wire 30B returns to a position where the circumferential interval from the center line S1 of the minor curvature side of the aortic arch is 0°.

[0058] During the process of the operator twisting the sheath 10B, when the traction wire 30B rotates from a position where the circumferential interval from the center line S1 of the minor curvature side of the aortic arch is 0° to approach the center line S2 of the major curvature side of the aortic arch, the traction wire torque formed by the traction wire 30B hinders the twisting of the sheath 10B. Therefore, the operator needs to provide a greater operating torque to offset the traction wire torque and drive the sheath 10B to rotate. However, providing a greater operating torque will reduce the accuracy of the operator's manual control, and it is easy to occur that after the traction wire 30B rotates along the W direction and crosses the center line S2 of the major curvature side of the aortic arch, the operator's reaction is not timely and fails to lock the circumferential position of the sheath 10B in time.

[0059] Furthermore, when the traction wire 30B rotates along the W direction to cross the center line S2 of the major curvature side of the aortic arch, the direction of the traction wire torque becomes the same as the direction of the operating torque, and the driving effects of the two are superimposed, and the sheath 10B will accelerate to rotate along the W direction and return to the initial position where the circumferential interval from the center line S1 of the minor curvature side of the aortic arch is 0°.

[0060] The operator needs to repeat the above operations of the sheath 10B many times, and each time the operator rotates the sheath 10B, the operator needs to highly concentrate, so as to be able to lock the circumferential position of the sheath in time at the moment when the circumferential interval between the traction wire 30B and the center line S2 of the major curvature side of the aortic arch is 0°, so that the nozzle of the sheath 10B is aligned with the brachiocephalic artery near the center line S2 of the major curvature side of the aortic arch. Therefore, the positioning of the sheath in the prior art is difficult.

[0061] Based on this, the present disclosure discloses an adjustable bending sheath. During the twisting process of the sheath tube, when the angle circumferentially between the main body of the pulling wire and the center line S2 of the large curvature side of the aortic arch is a value within (0°, 30°), the two branches of the wire group are respectively located on both sides of the center line S2 of the large curvature side of the aortic arch. The directions of the pulling wire torques of the two branches of the wire group are opposite, and the pulling wire torques of the two branches of the wire group at least cancel each other out partially, so that the magnitude of the combined torque of the pulling wire torques formed by the multiple branches is reduced, thereby reducing the interference of the pulling wire torque on the operator and further reducing the difficulty of positioning the sheath tube. Specifically as follows.

[0062] First Embodiment

[0063] Please refer to Figure 8 , the adjustable bending sheath 100 of an embodiment of the present disclosure includes a sheath tube 10 and a handle 30.

[0064] The sheath tube 10 includes an adjustable bending tube 110 and a main body tube 130. The proximal end of the adjustable bending tube 110 is connected to the distal end of the main body tube 130. The proximal end of the main body tube 130 is connected to the handle 30.

[0065] Please refer to Figure 8 and Figure 9 , the handle 30 includes a housing 310 and a sliding member 330. The housing 310 extends axially and has a receiving cavity 311. The distal end of the housing 310 is provided with a distal opening communicating with the receiving cavity 311, so that the proximal end of the main body tube 130 extends into the receiving cavity 311 from the distal opening. The housing 310 is connected to the proximal end of the main body tube 130. The proximal end of the housing 310 is provided with a proximal opening 312 communicating with the proximal end pipe orifice of the main body tube 130, so that the implanting instrument or the interventional instrument can enter the lumen of the sheath tube 10 from the proximal opening 312.

[0066] Please refer to Figure 9 , the housing 310 is provided with an axially extending track hole 313. The track hole 313 penetrates the side wall of the housing 310 in the radial direction and communicates with the receiving cavity 311.

[0067] Please refer to Figure 9 , the sliding member 330 is slidably disposed on the housing 310. Under the action of an external force, the sliding member 330 can slide axially on the housing 310.

[0068] The sliding member 330 includes an inner portion 331 and an external thread 333. In the radial direction, the inner portion 331 is located in the track hole 313 and is slidably engaged with the hole wall of the track hole 313. The external thread 333 is provided on the outer surface of the inner portion 331 and is located outside the track hole 313.

[0069] Please refer to Figure 8 and Figure 9The handle 30 further includes a knob 350. The knob 350 is rotatably sleeved on the housing 310, and an internal thread (not shown in the figure) meshing with the external thread 333 of the sliding member 330 is provided on the inner wall of the knob 350. When the knob 350 is rotated circumferentially under an external force, the sliding member 330 is driven to move axially on the housing 310. During this process, the inner side portion 331 of the sliding member 330 is in sliding fit with the track hole 313, so that the sliding member 330 slides axially on the housing 310.

[0070] Please refer to Figure 8 and Figure 9 In one embodiment, in order to axially limit the knob 350, an annular depression 315 is provided on the housing 310. The knob 350 is installed in the depression 315. The distal end of the knob 350 abuts against the distal side wall of the depression 315, and the proximal end of the knob 350 abuts against the proximal side wall of the depression 315, which can prevent the knob 350 from sliding axially relative to the housing 310 under the action of an axial force, so as to facilitate the knob to lock the axial position of the sliding member 330.

[0071] Please refer to Figure 10 An anchoring ring 150 is provided at the distal end of the adjustable bend pipe 110. The anchoring ring 150 is fixedly embedded in the pipe wall at the distal end of the adjustable bend pipe 110.

[0072] The adjustable bend sheath 100 further includes a pull wire 50. In one embodiment, the pull wire 50 includes a main trunk 510 and two branches 530 connected to the main trunk 510. The two branches 530 in this embodiment form a wire group G.

[0073] Among them, the distal end of the main trunk 510 is connected to the anchoring ring 150, and thus is connected to the distal end of the adjustable bend pipe 110 through the anchoring ring 150. The proximal end of the main trunk 510 extends axially, and the main trunk 510 is slidably embedded in the pipe wall of the adjustable bend pipe 110.

[0074] In Figure 10 In the shown embodiment, the main trunk 510 is a folded wire formed by folding a cable in half, which is equivalent to a single traction wire. The distal end of the folded wire is hooked on the anchoring ring 150. In other embodiments, the main trunk 510 is a single traction wire, and the distal end of the traction wire is fixedly connected to the anchoring ring 150 by welding. The traction wire can be a single-strand wire. The traction wire can also be a multi-strand wire.

[0075] Please refer to Figure 10 The distal ends of the two branches 530 are both connected to the proximal end of the main trunk 510. The proximal ends of the two branches 530 extend in the direction of the proximal end of the main body organ 130, and the proximal ends of the two branches 530 both extend outside the sheath 10.

[0076] Both of the two branches 530 include a wire body portion 531 that is slidably embedded in the tube wall of the main body tube 130 and extends axially. Both of the two wire body portions 531 extend axially within the tube wall of the main body tube 130, and the wire body portions 531 of the two branches 530 are circumferentially spaced apart within the sheath tube 10. In Figure 10 In the illustrated embodiment, the two wire body portions 531 are located on both circumferential sides of the main trunk 510. The circumferential angle between the two wire body portions 531 is 180°, and both of the two wire body portions 531 are circumferentially spaced 90° from the main trunk 510 within the sheath tube 10. That is, the circumferential angle between the two branches of the wire group G in this embodiment is 180°. It should be noted that the circumferential angle between the two wire body portions 531 within the sheath tube 10 is equal to the central angle corresponding to the tube body located between the two wire body portions 531.

[0077] In Figure 10 In the illustrated embodiment, in order to facilitate the circumferential arrangement of the wire body portion 531, both of the two branches 530 include a connecting portion 532 connected to the distal end of the wire body portion 531, and one end of the connecting portion 532 of the two branches 530 that is away from the wire body portion 531 is connected to the main trunk 510. In this embodiment, the two connecting portions 532 extend 90° in opposite directions circumferentially from the portion connected to the main trunk 510, so that the wire body portions 531 of the two branches 530 are circumferentially spaced 180° within the sheath tube 10, and the wire body portions 531 of the two branches 530 are both circumferentially spaced 90° from the main trunk 510, and the wire body portions 531 of the two branches 530 are located on both circumferential sides of the main trunk 510. In other embodiments, those skilled in the art can, according to requirements, set the circumferential extension angle and extension length of the connecting portion 532, so as to set the circumferential position of the wire body portion 531 connected to the connecting portion 532, and set the relative circumferential positional relationship between the wire body portion 531 and the main rod 510.

[0078] Please refer to Figure 10 , the portion of each branch 530 located outside the sheath tube 10 is an extension portion 533. In each branch 530, the distal end of the extension portion 533 is connected to the proximal end of the wire body portion 531. Please refer to Figure 11 and Figure 12 together, the proximal end of the extension portion 533 is connected to the sliding member 330.

[0079] When the sliding member 330 is located at the distal end of the track hole 313, the pulling force applied by the sliding member 330 to each branch 530 is small or no pulling force is applied, and the sheath tube 10 is not deformed by an external force and remains in a straight shape.

[0080] When the slider 330 is driven by the knob 350 to slide axially towards the proximal end, a pulling force can be applied to multiple branches 530. The pulling force is transmitted through the wire 50 and the anchor ring 150 to the distal end of the adjustable bending tube 110, causing the adjustable bending tube 110 to bend (i.e., adjusting the bending of the adjustable bending tube 110).

[0081] After adjusting the bending of the adjustable bending tube 110, when it is necessary to keep the adjustable bending tube 110 at a certain bending angle, the torque applied to the knob 350 is revoked, so that the knob 350 and the slider 330 are locked in the axial position of the housing 310, thereby keeping the bending tube 110 at this bending angle.

[0082] When it is necessary to restore the shape of the adjustable bending tube 110 to the non-bent shape or reduce the bending angle of the adjustable bending tube 110, it can be achieved by driving the slider 330 to slide axially towards the distal end by the knob 350.

[0083] It should be noted that in the following text and drawings, in order to facilitate indicating the circumferential positions of the main trunk 510, the wire part 531 of the branch 530, the center line S1 of the minor curvature side of the aortic arch, and the center line S2 of the major curvature side of the aortic arch and their relative positional relationships with each other, Figures 13 to 16 the main trunk 510, the wire part 531, the center line S1 of the minor curvature side of the aortic arch, and the center line S2 of the major curvature side of the aortic arch are respectively indicated by dot-like structures. Based on the same requirement, the main trunk 510 and the wire part 531 located in different cross-sections are indicated in the same cross-section.

[0084] During the use of the adjustable bending sheath 100, the operator first pushes the sheath tube 10 along the patient's blood vessel, so that the distal end of the sheath tube 10 is near the brachiocephalic artery of the aortic arch.

[0085] Then, the adjustable bending tube 110 is bent according to the above method of bending the sheath tube 10. After completing the bending of the adjustable bending tube 110, the operator revokes the torque acting on the knob 350 so that the adjustable bending tube 110 is kept at this bending angle. Please refer to Figure 13 ., when the operator completes the bending of the sheath tube 10, the bending shape of the adjustable bending tube 110 is roughly the same as the bending shape of the aortic arch, that is, the nozzle of the sheath tube 10 faces the center line S1 of the minor curvature side of the aortic arch. As Figure 13 shown, in the circumferential direction of the aortic arch, the angle between the main trunk 510 and the center line S1 of the minor curvature side of the aortic arch in the circumferential direction is 0°. Correspondingly, the two wire parts 531 are respectively located on both sides of the circumferential direction of the center line S2 of the major curvature side of the aortic arch, and the included angles with the center line S2 of the major curvature side of the aortic arch in the circumferential direction are both 90°.

[0086] Then, the operator applies an operating torque to the sheath tube 10 to rotate the sheath tube 10 in the W direction within the patient's blood vessel. The main body 510 gradually approaches the center line S2 of the major curvature side of the aortic arch. During this process, since the two wire body parts 531 are circumferentially located on both sides of the main body 510, one of the two wire body parts 531 will necessarily cross the center line S2 of the major curvature side of the aortic arch earlier than the main body 510.

[0087] That is, when the angle r between the main body 510 and the center line S2 of the major curvature side of the aortic arch in the circumferential direction is less than 90° as shown in Figure 14 shown, the two wire body parts 531 are respectively located on both circumferential sides of the center line S2 of the major curvature side of the aortic arch, and the traction wire torques of the two wire body parts 531 are the traction wire torques T1 and T2 shown in Figure 15 respectively. Their directions are opposite. Therefore, the magnitude of the combined torque of the traction wire torques T1 and T2 of the two branches 530 will decrease. The smaller the magnitude of the combined torque, the more beneficial it is to reduce the interference caused by the two branches 530 to the operator's twisting of the sheath tube 10, and the more beneficial it is to reduce the operation difficulty of the operator's twisting of the sheath tube 10, thereby improving the circumferential positioning accuracy of the sheath tube 10.

[0088] Moreover, the angles between the two wire body parts 531 and the main body 510 in the circumferential direction are equal (both are 90°). Therefore, the smaller the angle between the main body 510 and the center line S2 of the major curvature side of the aortic arch in the circumferential direction, the closer the tension degrees of the two branches 530 located on both sides of the center line S2 of the major curvature side of the aortic arch are, and the smaller the magnitude of the combined torque of the traction wire torques of the two branches 530 will be, which is more beneficial to reducing the operation difficulty for the operator to twist the sheath tube 10 to make the circumferential position of the main body 510 the same as the circumferential position of the aortic arch. When the angle between the main body 510 and the center line S2 of the major curvature side of the aortic arch in the circumferential direction is equal to 0°, the magnitude of the combined torque of the traction wire torques of the two branches 530 is zero, and the two branches 530 will not cause interference to the operator's twisting of the sheath tube 10.

[0089] In addition, even if due to the operator's hand tremor or other reasons, such as Figure 16The shown main body 510 rotates to cross the center line S2 of the major curvature side of the aortic arch. However, as long as the two wire body parts 531 are located on both sides of the center line S2 of the major curvature side of the aortic arch (that is, the angle r between the main body 510 and the center line S2 of the major curvature side of the aortic arch in the circumferential direction is less than 90°, that is, one wire body part 531 has crossed the center line S2 of the major curvature side of the aortic arch, and the other wire body part 531 has not crossed the center line S2 of the major curvature side of the aortic arch), the directions of the traction wire torques of the two wire body parts 531 are opposite. Since after the main body 510 crosses the center line S2 of the major curvature side of the aortic arch, the wire body part 531 that has not crossed the center line S2 of the major curvature side of the aortic arch is closer to the center line S2 of the major curvature side of the aortic arch in the circumferential direction than the wire body part 531 that has crossed the center line S2 of the major curvature side of the aortic arch, the magnitude of the traction wire torque of the wire body part 531 that has not crossed the center line S2 of the major curvature side of the aortic arch is larger than that of the wire body part 531 that has crossed the center line S2 of the major curvature side of the aortic arch, and the direction of the traction wire torque of this wire body part 531 is opposite to the rotation direction W of the sheath 10, so that the direction of the combined torque of the traction wire torques of the two branches 530 is opposite to the rotation direction W of the sheath 10, which can prevent the sheath 10 from continuing to rotate along the W direction or reduce the effect of the rotation speed of the sheath 10, enabling the operator to have a time window for operating the sheath 10 (that is, the period of time from when the main body 510 rotates to cross the center line S2 of the major curvature side of the aortic arch until both wire body parts 531 cross the center line S2 of the major curvature side of the aortic arch). The operator can reversely twist the sheath 10 (or reversely twist the sheath 10 after locking the circumferential position of the sheath 10) to rotate the circumferential position direction of the main body 510 to an angle r of 0° with respect to the circumferential interval from the center line S2 of the major curvature side of the aortic arch, so that the nozzle at the distal end of the sheath 10 is aligned with the brachiocephalic trunk artery. It is not necessary to require the operator to react at the moment when the angle r is 0°.

[0090] Moreover, during the rotation of the sheath 10 along the W direction, after one of the two branches 530 crosses the center line S2 of the major curvature side of the aortic arch in the circumferential direction, the direction and magnitude of the combined torque of the two branches 530 will both change, and this change is fed back to the hand of the operator operating the sheath 10 in the form of touch, which is beneficial to prompting the operator to reversely twist the sheath 10 in time (or reversely twist the sheath 10 after locking the circumferential position of the sheath 10).

[0091] Therefore, compared with the prior art, during the twisting process of the adjustable bending sheath 100 of the present embodiment, the difficulty of circumferential positioning is lower, and the fault tolerance of the operation is better. During use, the number of times the operator rotates the sheath 10 can be reduced, thereby saving the operation time.

[0092] In one embodiment, the number of branches 530 is an integer greater than or equal to 3, the number of wire groups G is one, and only one of the multiple branches 530 forms a wire group G with another branch 530. The angle between two branches 530 in the wire group G is any value within [60°, 180°] except 180°. The wire body part 531 of one branch 530 in the wire group G is located on one side of the main body 510 in the circumferential direction, and the wire body part 531 of the other branch 530 in the wire group G is located on the other side of the main body 510 in the circumferential direction, or the angle between the wire body part 531 of the other branch 530 in the wire group G and the main body 510 in the circumferential direction is 0°. With such a setting, when the sheath 10 is twisted by the operator towards the center line S2 of the large curvature side of the aortic arch, when the angle r between the main body 510 and the center line S2 of the large curvature side of the aortic arch in the circumferential direction is a value within (0°, 30°), the two branches 530 in the wire group G are located on both circumferential sides of the center line S2 of the large curvature side of the aortic arch. Therefore, the traction wire torques generated by the two branches 530 in the wire group G cancel each other out partly due to the opposite directions, so that the magnitude of the resultant torque of the wire group G is reduced, and further the magnitude of the resultant torque of the traction wire torques of the multiple branches 530 is reduced, which is beneficial to reducing the positioning difficulty of the sheath 10.

[0093] In another embodiment, some or all of the multiple branches 530 form multiple wire groups G, and the branches 530 between different wire groups G are all different. The angle between two branches 530 in each wire group G is any value within [60°, 180°].

[0094] Moreover, in each wire group G, the wire body part 531 of one branch 530 is located on one side of the main body 510 in the circumferential direction, and the wire body part 531 of the other branch 530 in the wire group G is located on the other side of the main body 510 in the circumferential direction. Or, the angle between the wire body part 531 of the other branch 530 and the main body 510 in the circumferential direction is 0°.

[0095] With such a setting, when the sheath 10 is twisted by the operator towards the center line S2 of the large curvature side of the aortic arch, when the angle r between the main body 510 and the center line S2 of the large curvature side of the aortic arch in the circumferential direction is a value within (0°, 30°), the traction wire torques generated by the two branches 530 in each wire group G cancel each other out at least partly, so that the value of the resultant torque of the traction wire torques of the multiple branches 530 is further reduced, thereby further reducing the positioning difficulty of the sheath 10 during the process of the operator twisting the sheath 10.

[0096] In one embodiment, the wire portions 531 of the multiple branches 530 are evenly distributed circumferentially within the main tube 130. When the multiple branches 530 are subjected to tensile forces, each wire portion 531 of the branches 530 will generate a radial force on the main tube 130. Since the wire portions 531 of the multiple branches 530 are evenly distributed circumferentially within the main tube 130, the radial forces exerted by the wire portions 531 of the multiple branches 530 on the main tube 130 at least cancel each other out in part, which is beneficial to reducing the amplitude of bending deformation of the main section 130 during the bending process. The smaller the bending amplitude of the main section 130, the smaller the change in length of the branch 530 when the branch 530 rotates by a certain angle circumferentially. Therefore, the torque of the traction wire of the branch 530 is smaller, and the interference of the pull wire 50 on the operator is smaller, thus facilitating the reduction of the difficulty of circumferential positioning when the sheath tube 10 is twisted.

[0097] In one embodiment, the adjustable-bend sheath 100 may omit the handle 30. After omitting the handle 30, when the adjustable-bend tube 110 needs to be bent, one hand of the operator holds the proximal end of the main tube 130, and the other hand applies a proximal-directed tensile force to the proximal ends of the multiple branches 530 simultaneously by means of a tool (such as a clip) or directly (i.e., without using a tool). The adjustable-bend tube 110 bends and deforms under the action of the tensile force. After the bending angle of the adjustable-bend tube 110 meets the expectation, the magnitude of the tensile force on the multiple branches 530 is kept unchanged to lock the axial positions of the proximal ends of the multiple branches 530, so that the bending angle of the adjustable-bend tube 110 remains unchanged. When the sheath tube 10 needs to be twisted, the hand of the operator holding the main tube 130 applies an operating torque to the main tube 130, thereby driving the sheath tube 10 to rotate circumferentially. During the circumferential rotation of the sheath tube 10, the torque of the traction wires generated by the two branches 530 in the wire group G at least cancels each other out in part, thereby also reducing the difficulty of circumferential positioning of the sheath tube 10.

[0098] Second Embodiment

[0099] In this embodiment, the number of the multiple branches 530 is an even number, and they are grouped in pairs to form a wire group G.

[0100] The difference between this embodiment and the first embodiment is that the proximal ends (i.e., the proximal ends of the extension portions 533) of the two branches 530 in each wire group G are movably connected to the sliding member 330 (such as slidably passing through, rotatably connecting, deflectably connecting, etc.).

[0101] When the slider 330 slides proximally along the axis under an external force, a tensile force is applied to multiple branches 530. When the multiple branches 530 are under the tensile force and the tensions of the two branches 530 of the wire group G are not equal, the two branches 530 of the wire group G move synchronously relative to the slider 330 so that the tensions of the two branches 530 of the wire group G are equal. Since the time from the tensions of the two branches 530 of the wire group G to the movement of the proximal ends of the two branches 530 of the wire group G relative to the slider 330 to make the tensions of the two branches 530 equal is short, during the process of the two branches 530 being under the tensile force, the tensions of the two branches 530 of the wire group G are regarded as always equal.

[0102] During the process of the operator bending the adjustable bent tube 110, when the tensile force is constant, the tensions of the two branches 530 of the wire group G are always equal, which can reduce the risk of the branch 530 with a larger tension in the wire group G breaking due to the too large difference in the tensions of the two branches 530 of the wire group G.

[0103] During the process of the operator twisting the sheath 10, the tensions of the two branches 530 of the wire group G are always equal, and the torques of the traction wires of the two branches 530 of the wire group G are always equal. When the two branches 530 of the wire group G are rotated to be located on both sides of the center line S2 of the large curvature side of the aortic arch respectively, the directions of the torques of the traction wires of the two branches 530 are opposite, and the torques of the traction wires of the two branches 530 of the wire group G cancel each other out (i.e., the resultant torque is zero), enabling the operator to more stably control the sheath 10 and further reducing the positioning difficulty of twisting the sheath 10.

[0104] Third Embodiment

[0105] Please refer to Figure 17 , in this embodiment, an example is given with the number of wire groups G being one. In other embodiments, the number of wire groups G can be multiple.

[0106] Please refer to together Figures 17 to 19A , the proximal ends of the outer extension parts 533 of the two branches 530 of the wire group are connected to form a wire loop G1 at the proximal end of the wire group G, and the wire loop G1 is slidably penetrated through the slider 330. With this setting, during the process of the two branches 530 being stretched and when the tensions of the two branches 530 of the wire group G are not equal, the two branches 530 slide synchronously relative to the slider 330 so that the tensions of the two branches 530 of each wire group G are always equal. As long as the size of the angle between the main body 510 and the center line S2 of the large curvature side of the aortic arch in the circumferential direction is a value within (0°, 30°), the magnitude of the resultant torque of the torques of the traction wires generated by the two branches 530 of the wire group G is zero, which can further reduce the positioning difficulty of the sheath 10 during the twisting process.

[0107] Moreover, during the stretching process of the two branches 530, when the pulling force is constant, the tensions of the two branches 530 of the wire group G are always equal, which can reduce the risk of breakage of the branch with a larger tension caused by too large a tension difference between the two branches 530 of the wire group G.

[0108] Those skilled in the art can understand that when the number of the groups G is multiple, the proximal ends of the outer extensions 533 of the two branches 530 of each group G are connected to form a wire loop G1 at the proximal end of the wire group G. Each wire loop G1 can slidably pass through a sliding member 330. When the sheath 10 is twisted to an angle value within (0°, 30°) in the circumferential direction between the main body 510 and the center line S2 of the large curvature side of the aortic arch, the two branches 530 of the wire group G are located on both sides of the center line S2 of the large curvature side of the aortic arch, and the resultant torque of the traction wire torques of the two branches 530 of the wire group G is zero, reducing the magnitude of the resultant torque formed by the multiple branches 530, and further reducing the positioning difficulty of the sheath 10 during the twisting process. Moreover, when the multiple branches 330 are stretched, it can reduce the risk of breakage of the branch with a larger tension caused by too large a tension difference between the two branches 530 of the wire group G.

[0109] Please refer to Figure 19A and Figure 19B , a through hole 335 is formed in the sliding member 330, and a part of the wire loop G1 passes through the through hole 335, so that the wire loop G1 can slidably pass through the sliding member 330.

[0110] Please refer to Figure 17 , the adjustable bending sheath 100 further includes a drag reducer 60, and the drag reducer 60 can be a polytetrafluoroethylene film with better lubricity or other substances with better lubricity. The drag reducer 60 wraps around the outer surface of the wire loop G1. When the wire loop G1 passes through the sliding member 330, the drag reducer 60 is disposed between the hole wall of the through hole 335 and the wire loop G1. In other embodiments, the drag reducer 60 is in a cylindrical shape, a sheet shape or other shapes, and the drag reducer 60 is adhered to the hole wall of the through hole 335, so that when the wire loop G1 passes through the sliding member 330, the drag reducer 60 is disposed between the hole wall of the through hole 335 and the wire loop G1.

[0111] During the stretching process of the multiple branches 530, when the two branches 530 of the wire group G slide relative to the sliding member 330 synchronously due to unequal tensions with each other, since the drag reducer 60 is disposed between the hole wall of the through hole 335 and the wire loop G1, the friction force between the wire loop G1 and the hole wall can be reduced, which is beneficial to keeping the tensions of the two branches 530 of each wire group G equal during the process of the operator bending the adjustable bending tube 110 and twisting the sheath 10.

[0112] During the process of the operator bending the adjustable bent tube 110, under the same other conditions, the closer the wire body part 531 in the branch 530 and the extension part 533 connected to the wire body part 531 are to a straight line (that is, the larger the included angle formed by the connected wire body part 531 and the extension part 533 in the branch 530), the smaller the pulling force required for the pulling wire 50, and the more beneficial it is to reduce the risk of the pulling wire 50 breaking under the action of the pulling force.

[0113] In order to reduce the risk of the pulling wire 50 breaking under the action of the pulling force, it can be achieved by increasing the included angle formed by the connected wire body part 531 and the extension part 533 in each branch 530. In one embodiment, by setting the thickness of the part of the sliding member 330 where the perforation 335 is opened, the range of the ratio of the depth of the perforation 335 to the outer diameter of the sheath 10 is 90% to 100%. Under the same other conditions, the closer the ratio of the depth of the perforation 335 to the outer diameter of the sheath 10 is to 100%, the larger the included angle formed by the connected wire body part 531 and the extension part 533 in each branch 530, and the more beneficial it is to reduce the risk of the pulling wire 50 breaking under the action of the pulling force.

[0114] Fourth Embodiment

[0115] Please refer to Figures 20A to 21 In this embodiment, the difference from the third embodiment is that the adjustable bending sheath 100 further includes a rotating member 71 rotatably disposed on the sliding member 330, and the rotating member 71 can be a rotating shaft. There is a bearing member 72 provided on the sliding member 330, and the rotating member 71 is rotatably disposed on the bearing member 72, so as to be rotatably disposed on the sliding member 330 through the bearing member 72. The bearing member 72 can be a bearing fixedly connected to the sliding member 330.

[0116] In Figures 20A to 21 In the embodiment shown, the number of the wire groups G is one, and the number of the rotating members 71 is also one. The wire loop G1 is sleeved on the rotating member 71. When multiple branches 530 are under the action of the pulling force and when the tensions of the two branches 530 of the wire group G are not equal, the rotating member 71 rotates around the rotation center under the drive of the two branches 530 of the wire group G, so that the tensions of the two branches 530 of each wire group G are always equal. When the sheath 10 is twisted to a value within the range of (0°, 30°) of the circumferential interval between the main trunk 510 and the center line S2 of the large bend side of the aortic arch, the two branches 530 of the wire group G are located on both sides of the center line S2 of the large bend side of the aortic arch, and the combined torque of the traction wire torques of the two branches 530 of the wire group G is zero, which is beneficial to the positioning of the sheath 10.

[0117] In other embodiments, the number of wire groups G is multiple, the number of rotating members 71 is the same as the number of wire groups G, and the multiple rotating members 71 are arranged axially. In other embodiments, the arrangement of the multiple rotating members 71 may also be that the multiple rotating members 71 are arranged circumferentially. Or, a part of the multiple rotating members 71 is arranged circumferentially and the other part is arranged axially. The rotating members 71 are arranged in one-to-one correspondence with the wire groups G.

[0118] In the correspondingly arranged rotating member 71 and wire group G, the wire loop G1 is sleeved on the rotating member 71. When multiple branches 530 are subjected to tensile force and the tensions of the two branches 530 of the wire group G are not equal, the rotating member 71 rotates around the rotation center under the drive of the two branches 530 of the wire group G corresponding to it, so that the tensions of the two branches 530 of each wire group G are always equal. When the sheath 10 is twisted to a value within the range of (0°, 30°) of the circumferential interval between the main body 510 and the center line S2 of the large curvature side of the aortic arch, the two branches 530 of the wire group G are located on both sides of the center line S2 of the large curvature side of the aortic arch, and the combined torque of the traction wire torques of the two branches 530 of the wire group G is zero, which is beneficial to reducing the risk of branch 530 breakage during the process of the operator bending the adjustable bending tube 110, and is beneficial to reducing the positioning difficulty of the sheath 10 during the process of the operator twisting the sheath 10.

[0119] In order to reduce the risk of the pull wire 50 breaking under the action of tensile force, it can be achieved by increasing the included angle formed by the connected wire body part 531 and the extension part 533 in each branch 530. In one embodiment, by setting the ratio of the outer diameter of the rotating member 71 to the outer diameter of the sheath 10 in the range of 90% to 100%, it is beneficial to increase the included angle formed by the connected extension part 533 and the wire body part 531 in the branch 530, thereby being beneficial to reducing the risk of the pull wire 50 breaking under the action of tensile force.

[0120] Fifth Embodiment

[0121] Please refer to Figures 22A to 23 , the difference between this embodiment and the third embodiment is that the adjustable bending sheath 100 further includes a balance frame 80 provided on the sliding member 330.

[0122] In Figures 22A to 23 the shown embodiment, the balance frame 80 is located in the receiving cavity 311 of the housing 310. In other embodiments, the balance frame 80 may also be located outside the handle 30. The balance frame 80 is connected to the sliding member 330 through an intermediate connecting member that can slidably pass through the housing 310, and can synchronously drive the balance frame 80 to move axially when the sliding member 330 is driven. In short, regardless of whether the balance frame 80 is located in the receiving cavity 311 of the handle 30 or outside the handle 30, as long as the sliding member 330 can synchronously drive the balance frame 80 to move axially.

[0123] Please refer to Figures 22A to 23 , the balance frame 80 includes a connecting rod 81 and a balance rod 82. One end of the connecting rod 81 is fixedly connected to the sliding member 330, and the other end is movably connected to the balance rod 82. For example, the connecting rod 81 is movably connected to the balance rod 82 through a ball head, or the connecting rod 81 is movably and rotatably connected to the balance rod 82 through a pin shaft.

[0124] In Figures 22A to 23 all embodiments, the number of the wire groups G is one, and the number of the balance frames 80 is also one. The proximal ends of the two outer extensions 533 in the wire group G are respectively connected to both ends of the balance rod 82, so that the two branches 530 of the wire group G are movably connected to the sliding member 330. When the two branches 530 are subjected to tensile forces and the tensions of the two branches 530 of the wire group G are not equal, the balance rod 82 deflects, so that the tensions of the two branches 530 of the wire group G are equal, so that the two branches 530 of the wire group G are located on both sides of the center line S2 of the large bend side of the aortic arch, and the resultant torque of the traction wire torques of the two branches 530 of the wire group G is zero, which is beneficial to reducing the risk of the branch 530 breaking during the process of the operator bending the adjustable bend pipe 110, and is beneficial to reducing the positioning difficulty of the sheath 10 during the process of the operator twisting the sheath 10.

[0125] In other embodiments, the numbers of both the wire group G and the balance frames 80 are multiple, and the numbers of the wire group G and the balance frames 80 are the same. The multiple balance frames 80 are arranged axially. The balance frames 80 are arranged in one-to-one correspondence with the wire group G.

[0126] In the correspondingly arranged balance frames 80 and wire group G, both ends of the balance rod 82 are respectively connected to the proximal ends (i.e., the proximal ends of the outer extensions 533) of the two branches 530 of the wire group G. When the multiple branches 530 are subjected to tensile forces and the tensions of the two branches 530 of the wire group G are not equal, the balance rod 82 deflects, so that the tensions of the two branches 530 of the wire group G are equal.

[0127] Please refer to Figures 22A to 23 , the connecting rod 81 extends along the axial direction of the sheath 10, and the connecting rod 81 and the balance rod 82 are arranged axially along the sheath 10, which can reduce the radial dimension of each balance frame 80, and further can reduce the radial dimension of the receiving cavity 311 of the housing 310.

[0128] In one embodiment, the balance bracket 80 of the above embodiment can also be replaced with a universal joint (not shown in the figure). In one embodiment, the universal joint is a ball head universal joint. The universal joint includes a first part and a second part that are movably connected through a ball head. The first part is connected to the sliding member 330, and the second part is connected to the proximal ends of multiple branches 530. When the multiple branches 530 are subjected to a tensile force and the tensions of the multiple branches 530 are not equal, the second part moves relative to the first part so that the tensions of the multiple branches 530 are equal and cancel each other out, thereby reducing the positioning difficulty of the sheath 10. In this embodiment, it is not required that the multiple branches 530 form line groups G in pairs. The number of branches 530 connected to the second part can be even or odd, as long as each branch 530 is connected to the second part. Therefore, in the case where the positioning difficulty of the sheath 10 can be reduced, this embodiment has better applicability.

[0129] In other embodiments, the universal joint can also be other types of universal joints, as long as the first part and the second part can be movably connected.

[0130] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered to be within the scope described in this specification.

[0131] The above-disclosed are only the preferred embodiments of the present invention. Of course, the scope of the rights of the present invention cannot be limited thereby. Therefore, equivalent changes made according to the claims of the present invention still fall within the scope covered by the present invention.

Claims

1. An adjustable bending sheath, characterized in that, Comprising a sheath tube and a pull wire, the sheath tube includes an adjustable bending tube and a main body tube, the proximal end of the adjustable bending tube is connected to the distal end of the main body tube, and the pull wire includes: A main trunk, the main trunk is slidably embedded in the tube wall of the adjustable bending tube, the distal end of the main trunk is connected to the distal end of the adjustable bending tube, and the proximal end of the main trunk extends axially; Multiple branches, the distal ends of the multiple branches are all connected to the proximal end of the main trunk, the proximal ends of the multiple branches all extend proximally, and the proximal ends of the multiple branches all extend to the outside of the sheath tube. The multiple branches all include wire body parts slidably embedded in the tube wall of the main body tube, and the wire body parts of the multiple branches all extend axially. The multiple branches include at least one wire group formed by two of the branches. The range of the angle between the wire body parts of the two branches of the wire group in the circumferential direction is [60°, 180°], and, The wire body part of one branch of the wire group is located on one side of the main trunk in the circumferential direction, the wire body part of the other branch of the wire group is located on the other side of the main trunk in the circumferential direction, or the angle between the wire body part of the other branch of the wire group and the main trunk in the circumferential direction is 0°.

2. The bendable sheath according to claim 1, wherein The adjustable bending sheath further includes a handle, and the handle includes: A housing, the housing is connected to the proximal end of the main body tube; A sliding member, the sliding member is slidably disposed on the housing, the sliding member is movably connected to the proximal ends of the multiple branches, and the sliding member can slide axially on the housing under the action of an external force, so as to be able to apply a pulling force to the distal end of the adjustable bending tube through the pull wire, so that the adjustable bending tube is bent and deformed, or cancel the pulling force applied to the adjustable bending tube.

3. The deflectable sheath according to claim 2, wherein Each branch includes an extension part located outside the sheath tube. In each branch, the extension part and the wire body part are connected to each other; The number of the multiple branches is an even number, and they are grouped in pairs to form the wire groups. The proximal ends of the extension parts of the two branches of each wire group are connected to form a wire loop, and each wire loop slidably passes through the sliding member. When the multiple branches are subjected to a pulling force and the tensions of the two branches of the wire group are not equal, the two branches of the wire group slide synchronously relative to the sliding member so that the tensions of the two branches of the wire group are equal.

4. The deflectable sheath according to claim 3, wherein A through hole is formed in the sliding member, a part of the wire loop passes through the through hole, so that the wire loop is slidably disposed on the sliding member. The adjustable bending sheath further includes a drag reducing object, and the drag reducing object is disposed between the hole wall of the through hole and the wire loop.

5. The adjustable bending sheath according to claim 4, wherein, The ratio of the depth of the through hole to the outer diameter of the sheath tube ranges from 90% to 100%.

6. The bendable sheath according to claim 2, wherein Each branch includes an extension part located outside the sheath tube. In each branch, the extension part and the wire body part are connected to each other; The number of the multiple branches is an even number, and they are grouped in pairs to form the wire groups. The proximal ends of the extension parts of the two branches of each wire group are connected to form a wire loop; The adjustable bending sheath further includes a rotating member rotatably disposed on the sliding member. The number of the rotating members is greater than or equal to one. When the number of the rotating members is greater than one, the plurality of rotating members are arranged axially. The rotating members are arranged in one-to-one correspondence with the wire groups. And, in the correspondingly arranged rotating member and wire group, the wire loop is sleeved on the rotating member. When the plurality of branches are subjected to a tensile force and the tensions of the two branches of the wire group are not equal, the rotating member rotates around the rotation center under the drive of the two branches of the wire group, so that the tensions of the two branches of the wire group are equal.

7. The deflectable sheath according to claim 6, wherein The ratio of the outer diameter of the rotating member to the outer diameter of the sheath tube ranges from 90% to 100%.

8. The bendable sheath according to claim 2, wherein The housing forms a receiving cavity. The proximal end of the sheath tube is received in the receiving cavity. The adjustable bending sheath further includes a balance frame disposed on the sliding member. The number of the balance frames is greater than or equal to one. When the number of the balance frames is greater than one, the plurality of balance frames are arranged axially. The balance frame includes a connecting rod and a balance rod. One end of the connecting rod is fixedly connected to the sliding member, and the other end is movably connected to the balance rod. The balance frames are arranged in one-to-one correspondence with the wire groups. And, in the correspondingly arranged balance frame and wire group, the two ends of the balance rod are respectively connected to the proximal ends of the two branches of the wire group. When the plurality of branches are subjected to a tensile force and the tensions of the two branches of the wire group are not equal, the balance rod deflects, so that the tensions of the two branches of the wire group are equal.

9. The deflectable sheath according to claim 8, wherein The connecting rod extends along the axial direction of the sheath tube, and the connecting rod and the balance rod are arranged axially along the sheath tube.

10. The adjustable bending sheath according to claim 2, wherein, The adjustable bending sheath further includes a universal joint. The universal joint includes a first part and a second part that are movably connected. The first part is connected to the sliding member, and the second part is connected to the proximal ends of the plurality of branches. When the plurality of branches are subjected to a tensile force and the tensions of the plurality of branches are not equal, the second part moves relative to the first part, so that the tensions of the plurality of branches are all equal.

11. The steerable sheath according to any one of claims 1-10, characterized in that, The wire body parts of the plurality of branches are evenly distributed along the circumferential direction of the sheath tube.

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