Bidirectional adjustable bending sheath and interventional instrument

Abstract

The application discloses a bidirectional adjustable bending sheath and interventional instruments, the bidirectional adjustable bending sheath comprises a pipe body, the pipe body comprises a main body section and a bending adjusting section coaxially connected to the distal end of the main body section, the bending adjusting section can be bent towards a first direction and a second direction respectively, wherein the starting point and bending radius towards the first direction are different from the starting point and bending radius towards the second direction.The bidirectional adjustable bending sheath and interventional instruments of the application can realize the effect that the bending starting point and bending radius of the bidirectional adjustable bending sheath are different when bending in two directions by adjusting the hardness of the two sides of the bending adjusting section, so that when the bidirectional adjustable bending sheath is applied to the clinical scene that the openings of the two side branch vessels are not at the same height or the distance from the sheath body is different, the bidirectional adjustable bending sheath and interventional instruments of the application can more quickly and accurately superselect the two side branch vessels.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional medical instruments, in particular to a bidirectional adjustable bending sheath tube and an interventional instrument. BACKGROUND

[0002] The primary condition of interventional therapy is accurate positioning of the diseased blood vessel. In addition to the skilled operation and patience of the clinician, the catheter plays a crucial role in the interventional therapy operation. Due to the variability and complexity of the opening positions of peripheral blood vessels at all levels such as visceral arteries, iliac arteries, common carotid arteries, and innominate arteries relative to the aortic blood vessel, it is difficult to accurately position.

[0003] The adjustable bending sheath is a disposable subcutaneous puncture arterial sheath that integrates the adjustable bending function of superselective target blood vessels and arbitrary release angles of instruments, and can establish and provide a channel for the release and recovery of instruments. The adjustable bending sheath can enable the clinician to have the ability to challenge complex surgical cases with a superselective appropriate angle; at the same time, it can shorten the operation time and improve the efficiency, and has a certain irreplaceability in complex cases.

[0004] At present, the adjustable bending sheaths on the market have unidirectional adjustable bending sheath tubes and bidirectional adjustable bending sheath tubes, and the existing bidirectional adjustable bending sheaths, as shown in the prior art, have the same length of the bending segments when bidirectional bending, and the bending starting points are at the same position, so that the curvature radii R of the bending segments are the same after the sheath tube is bidirectionally bent to the same angle, or the TIP head height H1 and the distance H2 of the TIP head from the sheath tube body are the same. This design has the following problems: Figure 1 (1) When the openings of the two-sided branch blood vessels are not at the same height, the bidirectional adjustable bending sheath needs to select both the two-sided branch blood vessels at the same time (such as

[0005] ), it is difficult to vertically align the vessel openings after one side of the sheath tube is bent, but the other side is bent, which is not convenient for the establishment of a blood channel. At this time, the sheath tube needs to be pushed or withdrawn or the angle size needs to be adjusted to align the branch openings of the blood vessels, which increases the operation steps and prolongs the operation time. Figure 2 (2) When the distances of the two-sided branch blood vessels from the sheath tube body are different, the bidirectional adjustable bending sheath needs to select both the two-sided branch blood vessels at the same time (such as

[0006] ), the same problem of difficulty in alignment will occur. Figure 3 SUMMARY Based on this, the present application aims to provide a bidirectional adjustable bending sheath tube with different bending starting points and bending radii and an interventional instrument.

[0007] To achieve this purpose, on the one hand, the present application adopts the following technical solutions:

[0008]

[0009] ​A bidirectional adjustable bending sheath comprises a tube body, the tube body comprising a main body section and a bending adjustment section coaxially butted at a distal end of the main body section, the bending adjustment section being bendable towards a first direction and a second direction respectively; wherein a first starting point and a first bending radius towards the first direction are different from a second starting point and a second bending radius towards the second direction.

[0010] In one of the embodiments, the bending adjustment section has a hardness less than that of the main body section.

[0011] In one of the embodiments, at least part of the layers at the butting interface of the main body section and the bending adjustment section are wedge-shaped relative to the axis, such that the butting of the main body section and the at least part of the layers of the bending adjustment section is wedge-shaped butting.

[0012] In one of the embodiments, the tube body comprises, from inside to outside, an inner layer tube, a middle layer tube and an outer layer tube; the inner layer tube and / or the middle layer tube and / or the outer layer tube at the butting interface of the main body section are wedge-shaped relative to the axis, and the layers at the butting interface of the bending adjustment section opposite to the wedge-shaped layers of the main body section are wedge-shaped matching the wedge-shaped layers of the main body section.

[0013] In one of the embodiments, a reinforcing tube is further provided, which is sleeved with the bending adjustment section of the tube body, and the reinforcing tube is used to adjust the hardness of the first direction and the second direction on the bending adjustment section.

[0014] In one of the embodiments, the reinforcing tube comprises a first part and a second part butted in a radial direction, the reinforcing strength of the first part is lower than that of the second part, such that the starting point and the bending radius towards the first direction are different from the starting point and the bending radius towards the second direction.

[0015] In one of the embodiments, the first part is circumferentially provided with a first cutout having a first axial width.

[0016] In one of the embodiments, the second part is circumferentially provided with a second cutout having a second axial width, the axial width of the second cutout is less than the first axial width of the first cutout.

[0017] In one of the embodiments, the distal end of the reinforcing tube is wedge-shaped relative to the axis, such that the reinforcing tube has a distal end wedge-shaped port.

[0018] In one of the embodiments, the body of the reinforcing tube is circumferentially provided with a third cutout, the circumferential arc length of the third cutout from the proximal end to the distal end of the reinforcing tube decreases in sequence.

[0019] In one of the embodiments, the third cutout comprises a first sub-cutout and a second sub-cutout circumferentially spaced apart, and an axially extending reinforcing portion is formed between the circumferentially spaced apart first sub-cutout and second sub-cutout, and the first sub-cutout and the second sub-cutout on both sides of the reinforcing portion are mirror images.

[0020] In one of the embodiments, the tube body comprises an inner layer tube, a middle layer tube and an outer layer tube from inside to outside, and the reinforcing tube sleeve is sleeved between the middle layer tube and the outer layer tube at the proximal end of the bending section.

[0021] In one of the embodiments, a developing mark is further arranged on the tube body, and the developing mark comprises a first partial mark and a second partial mark arranged locally along the circumference of the tube body, the first partial mark and the second partial mark are respectively started from the first starting point and the second starting point, and the extending directions of the first partial mark and the second partial mark are opposite.

[0022] In one of the embodiments, the arc lengths of the first partial mark and the second partial mark on the tube body are less than or equal to one fourth of the tube circumference.

[0023] In one of the embodiments, at least part of the layers at the abutting portion of the main section and the bending section are wedge-shaped relative to the axis, so that when the abutting portion of the main section and the bending section is wedge-shaped abutment, the developing mark further comprises a first wedge-shaped mark and a second wedge-shaped mark arranged locally on the tube body along the profile track of the abutting portion, the first wedge-shaped mark and the second wedge-shaped mark are respectively started from the first starting point and the second starting point, and the extending directions of the first wedge-shaped mark and the second wedge-shaped mark are opposite.

[0024] In one of the embodiments, the tube body further comprises a TIP head coaxially abutting at the distal end of the bending section, and the bidirectional adjustable bending sheath further comprises a traction ring connected with the TIP head and a traction wire connected with the traction ring at the distal end thereof.

[0025] In another aspect, the present application adopts the following technical solutions:

[0026] An interventional instrument comprises a handle, a bending mechanism arranged in the handle, and the bidirectional adjustable bending sheath described above, the bending mechanism is connected with the bending section of the tube body of the bidirectional adjustable bending sheath through a traction wire, so that the bending section can be bent towards a first direction and a second direction respectively under the driving of the bending mechanism.

[0027] The bidirectional adjustable bending sheath and interventional instrument of the application can realize the effect that the bending starting point and the bending radius are different when the bidirectional adjustable bending sheath is bidirectionally bent, by adjusting the hardness of the bending adjustment section on both sides of the bending adjustment section, so that the bidirectional adjustable bending sheath and interventional instrument of the application can more quickly and accurately superselect the two branch blood vessels when the opening of the two branch blood vessels is not at the same height or the distance from the sheath body is different. In addition, when the angle of one bending side is not suitable during the selection of entering one branch blood vessel, the other bending side can be selected for operation immediately, which is convenient to operate and improves the applicability of the product. BRIEF DESCRIPTION OF DRAWINGS

[0028] Figure 1 It is a structural schematic diagram of the existing bidirectional adjustable bending sheath;

[0029] Figure 2 It is a bending state schematic diagram of the bidirectional adjustable bending sheath in Figure 1 when the opening of the two branch blood vessels is not at the same height;

[0030] Figure 3 It is a bending state schematic diagram of the bidirectional adjustable bending sheath in Figure 1 when the distance from the sheath body is different;

[0031] Figure 4 It is a schematic diagram of the interventional instrument including the bidirectional adjustable bending sheath of the application;

[0032] Figure 5 It is a structural schematic diagram of the bidirectional adjustable bending sheath of the embodiment 1 of the application;

[0033] Figure 6 It is a bending state schematic diagram of the bidirectional adjustable bending sheath of the embodiment 1 of the application;

[0034] Figure 7 It is a local half-section schematic diagram of the bidirectional adjustable bending sheath of the embodiment 1 of the application;

[0035] Figure 8 It is a local enlarged schematic diagram of F1 in Figure 7 ;

[0036] Figure 9 It is a local enlarged schematic diagram of F2 in Figure 7 ;

[0037] Figure 10 It is a schematic diagram of the sawtooth structure provided at the wedge-shaped joint of the main body section and the bending adjustment section in the bidirectional adjustable bending sheath of the embodiment 1 of the application;

[0038] Figure 11 It is a setting schematic diagram of the developing mark in the bidirectional adjustable bending sheath of the embodiment 1 of the application;

[0039] Figure 12 This is a schematic diagram of the structure of the bidirectional adjustable bend sheath before the reinforcing tube is fitted onto the tube body in Embodiment 2 of the present invention; wherein, the outer tube has been removed from the bidirectional adjustable bend sheath.

[0040] Figure 13 This is a schematic diagram of the structure of the bidirectional adjustable bend sheath tube after the reinforcing tube is sleeved onto the tube body in Embodiment 2 of the present invention; wherein, the outer tube is removed from the bidirectional adjustable bend sheath tube.

[0041] Figure 14 This is a schematic diagram of the reinforcing tube in the bidirectional adjustable bend sheath of the present invention, according to Embodiment 2 of the present invention.

[0042] Figure 15 This is a schematic diagram of the reinforcing tube in the bidirectional adjustable bend sheath of the present invention, according to Embodiment 3 of the present invention.

[0043] Figure 16 This is a schematic diagram of the structure of the bidirectional adjustable bend sheath tube after the reinforcing tube is sleeved onto the tube body in Embodiment 3 of the present invention; wherein, the outer tube is removed from the bidirectional adjustable bend sheath tube.

[0044] Figure 17 This is a schematic diagram of the reinforcing tube in the bidirectional adjustable bend sheath of the present invention, according to Embodiment 4 of the present invention.

[0045] Figure 18 This is a schematic diagram of the structure of the bidirectional adjustable bend sheath tube after the reinforcing tube is sleeved on the tube body in Embodiment 4 of the present invention; wherein, the outer tube is removed in the bidirectional adjustable bend sheath tube. Detailed Implementation

[0046] To make the objectives, technical solutions, and advantages of this invention clearer, exemplary embodiments of this disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of this disclosure are shown in the drawings, it should be understood that this disclosure can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of this disclosure and to fully convey the scope of this disclosure to those skilled in the art.

[0047] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0048] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0049] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0050] Additionally, it should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body, or the delivery system that delivers the medical device, closer to the operator is generally referred to as the "proximal end," and the end farther from the operator is referred to as the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device or delivery system are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0051] Because existing bidirectional adjustable bending methods with symmetrical bending on both sides have many problems when the branch vessels on both sides are at different heights or the distance between the sheath and the branches on both sides is not equal, this invention proposes a bidirectional adjustable bending sheath and interventional device with different bending starting points and bending radii. It aims to provide asymmetrical and diversified adjustment angles and methods to achieve rapid alignment, reduce operation steps, and shorten operation time.

[0052] In view of the above, referring to Figure 4 This invention provides a bidirectional adjustable bending sheath. The overall design concept of this bidirectional adjustable bending sheath is as follows: the bidirectional adjustable bending sheath includes a tube body 10, which includes a main section and an adjusting section coaxially connected to the distal end of the main section. Under external force, the adjusting section of the tube body 10 can bend in a first direction and a second direction, respectively, deviating from its central axis X. The first direction and the second direction are different. Preferably, the first direction and the second direction are opposite. Specifically, the starting point and bending radius of the bending in the first direction are different from those of the bending in the second direction. Figure 4 As shown, the bending segment can bend towards a first direction A and a second direction B, which is opposite to A. The starting point of the bend towards A is the first starting point a, and the bending radius is the first radius R1. The starting point of the bend towards B is the second starting point b, located below the first starting point a, and its bending radius is the second radius R2. The first starting point a and the second starting point b are located at different positions along the axial direction, and the first bending radius R1 is not equal to the second bending radius R2. The bending segment of the tube body 10 of the present invention has different bending lengths in two opposite directions, so that during the operation, the distal end of the tube body can be vertically aligned with different vascular branch openings without pushing or retracting the sheath or adjusting the angle, reducing operation steps, shortening operation time, and improving the success rate of the operation. In addition, when selecting to enter a branch vessel, if the angle of one bending side is not suitable, the other bending side can be immediately adjusted and selected for operation, which is convenient and improves the applicability of the product.

[0053] In some embodiments, to ensure the supporting strength of the sheath tube 10 during transport and to ensure effective bending of the distal end of the tube while minimizing the applied force during long-distance pulling, the hardness of the bending section is less than that of the main body section. Preferably, the hardness of the bending section is between 20D and 50D, and the hardness of the main body section is between 60D and 80D.

[0054] Additionally, see Figure 5 As shown, the tube body 10 may further include a TIP head 13 coaxially connected to the distal end of the bending section. Preferably, the hardness of the TIP head 13 is greater than that of the bending section, thereby enhancing the hardness of the sheath end and facilitating the insertion of the sheath into the blood vessel. For ease of manufacturing, the hardness of the TIP head 13 is the same as that of the main body. The circumferential edge of the distal end of the TIP head 13 is inclined inward, resulting in a constricted distal end. This constriction not only facilitates the guidance of the tube body into the blood vessel but also prevents damage to the blood vessel wall from the frustum-shaped structure of the distal edge of the TIP head.

[0055] For further details, please refer to [link / reference]. Figure 5As shown, the bidirectional adjustable bending sheath may further include a traction structure for bending the bending section of the tube body 10. The traction structure includes at least a traction wire 21. When the distal end of the bending section does not have a TIP head 13, the distal end of the traction wire 21 is connected to the bending section, and bending is achieved by pulling the proximal end of the traction wire 21. When the distal end of the bending section has a TIP head 13, the distal end of the traction wire 21 is connected to the TIP head 13, and bending is achieved by pulling the proximal end of the traction wire 21. In other preferred embodiments, to facilitate the connection between the traction wire 21 and the tube body 10, the traction structure also includes a traction ring 22. When the distal end of the bending section does not have a TIP head 13, the traction ring 22 is sleeved and relatively fixed to the bending section, and the distal end of the traction wire 21 is then connected to the traction ring 22, thereby connecting the distal end of the traction wire 21 to the bending section. When the distal end of the bending section is equipped with a TIP head 13, the traction ring 22 is sleeved with and relatively fixed to the TIP head 13, and the distal end of the traction wire 21 is then connected to the traction ring 22, thereby achieving the connection between the distal end of the traction wire 21 and the TIP head 13. Furthermore, the bidirectional adjustable bending sheath also includes contrast markers on the tube body 10. Preferably, the contrast markers include a first local marker 41a and a second local marker 41b partially disposed circumferentially along the tube body 10, with the first local marker 41a and the second local marker 41b respectively starting from a first starting point a and a second starting point b, and their extension directions being opposite to each other. Distributing the first local marker 41a and the second local marker 41b partially circumferentially along the tube body 10, starting from the first starting point a and the second starting point b, not only facilitates the identification of the bending start point but also allows for accurate positioning of the blood vessel where the tube body 10 is located. Furthermore, in order to enable rapid identification and adjustment, the arc lengths of the first local mark and the second local mark on the pipe body are less than or equal to one-quarter of the pipe body circumference, so that the projections of the first local mark and the second local mark on the radial plane of the pipe body passing through the first starting point a and the second starting point b are less than or equal to the radius of the pipe body.

[0056] Specifically, as one configuration of the traction structure, it can be located outside the pipe body 10. For example, when the traction structure does not include the traction ring 22, the traction wire 21 is placed outside the pipe body 10, and the distal end of the traction wire 21 is directly connected to the outer wall of the pipe body 10, thereby achieving bending of the bending section by pulling from the outside of the pipe body 10. When the traction structure includes the traction ring 22, the traction ring 22 is sleeved on the outer wall of the pipe body 10 and fixed relative to the pipe body 10, and the distal end of the traction wire 21 is then connected to the traction ring 22, thereby achieving bending of the bending section by pulling from the outside of the pipe body 10.

[0057] As another configuration of the traction structure, the traction structure can be housed within the pipe body 10. For example, when the traction structure does not include the traction ring 22, the traction wire 21 is placed inside the pipe body 10, with the distal end of the traction wire 21 connected to the interior of the pipe body 10 and the proximal end of the traction wire 21 extending out of the pipe body 10. Pulling the traction wire 21 out of the pipe body 10 achieves bending of the bending section. When the traction structure includes the traction ring 22, the traction ring 22 is fitted inside the pipe body 10 and fixed relative to the pipe body 10. The distal end of the traction wire 21 is connected to the traction ring 22, and the proximal end of the traction wire 21 extends out of the pipe body 10. Pulling the traction wire 21 out of the pipe body 10 achieves bending of the bending section.

[0058] It should be noted that the traction structure and its configuration are not limited to the above. They can be selected and configured according to actual needs, or further optimized and improved based on them.

[0059] Furthermore, based on the aforementioned bidirectional adjustable bendable sheath, the present invention also provides an interventional device, see [link to relevant documentation]. Figure 4 As shown, the interventional device 100 includes a handle (not shown), a bending mechanism (not shown) disposed within the handle, and the aforementioned bidirectional adjustable bending sheath. The bending mechanism is connected to the distal end of the bidirectional adjustable bending sheath via a traction wire, allowing the sheath to bend in a first direction and a second direction respectively under the drive of the bending mechanism. The specific structures of the handle and the bending mechanism are described in the prior art and will not be repeated here.

[0060] Example 1

[0061] Reference Figure 5 Based on the overall design concept of the bidirectional adjustable bending sheath described above, this embodiment exemplifies a specific implementation of a bidirectional adjustable bending sheath. As shown in the figure, the bidirectional adjustable bending sheath of this embodiment includes a tube body 10, which includes a main body segment 11 and an adjusting segment 12 coaxially connected to the distal end of the main body segment 11. The adjusting segment 12 and the main body segment 11 are coaxially connected, sharing a common axis X. The hardness of the adjusting segment 12 is less than that of the main body segment 11. At least a portion of the layers at the interface between the adjusting segment 12 and the main body segment 11 are wedge-shaped, inclined relative to the axis X, making the connection between at least a portion of the layers of the adjusting segment 12 and the main body segment 11 a wedge-shaped connection. The wedge shape allows the adjusting segment 12 and the main body segment 11, which have different hardnesses, to form a wedge-shaped transition at the connection point, creating two different bending starting points and bending radii axially. The TIP head 13 and the traction structure in this embodiment can be referred to the foregoing description. The foregoing description in this embodiment refers to the description of the overall design concept of the bidirectional adjustable bending sheath (the same applies below). This embodiment mainly provides a detailed example of the structure for achieving asymmetrical bending in the 10-part tube body of the sheath.

[0062] See Figure 6As shown, the traction wires 21 on both sides of the bidirectional adjustable bending sheath in this embodiment are pulled respectively. Under the drive of the traction wires 21, the bending section 12 can bend towards a first direction A, which is deviated from its central axis X, and towards a second direction B, which is contrary to the first direction A. The starting point and bending radius of the bending towards the first direction A are different from those of the bending towards the second direction. Specifically, the starting point of the bending towards the A side is the first starting point a, and the starting point of the bending towards the B side is the second starting point b, which is located below the first starting point a. The first starting point a and the second starting point b are located at different axial positions. Furthermore, due to the wedge-shaped setting, the bending lengths on both sides are different, resulting in different bending radii on both sides. This method not only achieves asymmetrical bidirectional bending but also has a simple structure, low manufacturing difficulty, and low cost.

[0063] For example, such as Figure 7 As shown, the tube body 10 includes an inner tube 10a, a middle tube 10b, and an outer tube 10c from the inside out. At the interface of the main body segment 11, the inner tube 10a and / or the middle tube 10b and / or the outer tube 10c are wedge-shaped and inclined relative to its axis X. At the interface of the bending segment 12, the layer opposite to the wedge-shaped layer of the main body segment 11 is wedge-shaped and matches the wedge-shaped layer of the main body segment 11. Since one, two, or three of the inner tube 10a, middle tube 10b, and outer tube 10c can be configured as two segments with different hardnesses in the axial direction, and the interface of the two axial segments can be made into relatively inclined wedge shapes, their configuration can achieve the purpose of allowing the bending segment 12 to bend in a first direction and a second direction respectively, with the starting point and bending radius of the bending in the first direction being different from those of the bending in the second direction. It should be noted that the tube body 10 in this embodiment includes three layers. This is only an example based on the existing number of layers of the tube body 10 structure and is not limited thereto. For example, the number of layers of the tube body 10 can also be set to one, two or more layers. However, regardless of the number of layers, the general idea of ​​different hardness and wedge-shaped arrangement can refer to the three-layer arrangement method of this embodiment.

[0064] In this embodiment, the specific wedge-shaped configurations of the inner tube 10a, middle tube 10b, and outer tube 10c in the three-layer structure are not all illustrated here. This embodiment only illustrates the wedge shape at the interface of the outer tube 10c, which is inclined relative to its axis X. Configurations of other layers, or other two or three layers, can refer to this embodiment. Furthermore, in this embodiment, the tube body 10 includes a TIP head 13 and a bidirectional adjustable bending sheath including a traction structure, with the traction structure located within the tube body 10. That is, the bidirectional adjustable bending sheath of this embodiment includes a tube body 10 and a traction structure. The tube body 10 includes a TIP head 13, an adjusting section 12, and a main body section 11 connected axially from distal to proximal. The traction structure includes a traction ring 22 and two traction wires 21.

[0065] Specifically, in combination Figure 7 and Figure 8 The inner tube 10a is a PTFE tube, the middle tube 10b is a spring tube or braided mesh tube, and the outer tube 10c is an outer polymer tube. The PTFE tube is located at the innermost layer of the sheath, extending throughout the entire tube body 10 and providing a smooth inner cavity for the sheath, facilitating the transport of other instruments. The traction ring 22 is made of stainless steel and is located at the sheath tip 13, fitted over the outer wall of the PTFE tube and encased in the 72DPEBAX tube at the tip 13. The traction wire 21 is made of stainless steel and consists of two symmetrically distributed wires, which are welded to the traction ring 22 respectively. It is located between the outer wall of the PTFE tube and the inner wall of the middle tube 10b. The traction wire 21 extends from the end of the sheath tip 13 to the end of the main body section 11. The end of the traction wire 21 is connected to the bending mechanism of the handle. By adjusting the bending mechanism of the handle, the traction wire 21 can be pulled. The traction wire 21 transmits the tension to the traction ring 22. Because the hardness of the bending section 12 is lower than that of the main body section 11, the bending section 12 bends after being subjected to force on one side, while the main body section 11 does not bend, thereby achieving the effect of bending the distal end of the sheath.

[0066] The middle layer, consisting of a spring tube or braided mesh tube, is made of stainless steel. When it is a spring tube, it is spiral-shaped. When it is a braided mesh tube, it is woven from stainless steel wire. The spiral spring tube or braided mesh extends from the bending section 12 to the end of the main body section 11, fitting over the outer wall of the inner PTFE tube and the traction wire 21, and encasing the outer polymer tube, thus reinforcing the sheath. In this embodiment, the middle layer tube 10b is a spring tube.

[0067] Combination Figure 7 to 9 The outer polymer tube, located in the outermost layer, includes a first segment 10c1 at its distal end and a second segment 10c2 axially connected to the first segment 10c1. The hardness of the first segment 10c1 is less than that of the second segment 10c2. The proximal interface of the first segment 10c1 is wedge-shaped, inclined relative to its axis X. Correspondingly, the distal interface of the second segment 10c2 is wedge-shaped, matching the proximal interface of the first segment 10c1, making the connection between the first segment 10c1 and the second segment 10c2 of the outer polymer tube a wedge-shaped connection. Through the different hardnesses of the outer polymer tubes and the wedge-shaped arrangement, the main body segment 11 and the bending segment 12 of the tube body 10 are formed. For example, the first segment 10c1 is a 35DPEBAX tube, and the second segment 10c2 is a 72DPEBAX tube. The hardness of the 72DPEBAX tube in the second segment is greater than that of the 35DPEBAX tube in the first segment. Additionally, to ensure the hardness of the TIP head 13, the TIP head 13 segment is a 72DPEBAX tube. In addition, based on the above, see also Figure 10As shown, the interface between the main body section 11 and the bending section 12 is provided with a serrated structure, which enhances the connection strength between the main body section 11 and the bending section 12, while improving the stability during the bending process and avoiding bending caused by local stress concentration.

[0068] Reference Figure 5 , Figure 6 and Figure 11 As shown, the imaging marks in this embodiment include a first local mark 41a and a second local mark 41b partially disposed circumferentially along the tube body 10. The first local mark 41a and the second local mark 41b are respectively starting from a first starting point a and a second starting point b, and their extension directions are opposite to each other. Distributing the first local mark 41a and the second local mark 41b partially circumferentially along the tube body 10, starting from the first starting point a and the second starting point b, not only facilitates the identification of the bend initiation point but also allows for accurate positioning of the blood vessel where the tube body 10 is located. Furthermore, to enable rapid identification and rotational adjustment, the arc length of the first local mark and the second local mark on the tube body is less than or equal to one-quarter of the tube body circumference, such that the projection of the first local mark and the second local mark in the radial plane passing through the first starting point a and the second starting point b is less than or equal to the radius of the tube body.

[0069] In another embodiment, the developing marks of this embodiment further include a first wedge-shaped mark 41b and a second wedge-shaped mark 42b partially disposed on the tube body 10 along the contour trajectory of the mating interface. The first wedge-shaped mark 41b and the second wedge-shaped mark 42b have their starting ends at a first starting point a and a second starting point b, respectively, and their extending directions are opposite to each other. This arrangement not only allows the operator to quickly identify the bending starting point but also allows for a clear and intuitive determination of the bending direction.

[0070] Furthermore, considering the wedge-shaped connection and development requirements of this embodiment, and taking into account the process difficulty, in other embodiments, a developable connecting segment can be provided between the bending section 12 and the main body section 11. The two ends of the connecting segment are wedge-shaped connected to the bending section 12 and the main body section 11, respectively, and the hardness of the connecting segment is between that of the bending section 12 and the main body section 11. This arrangement eliminates the need for development marks on the tube body 10 during manufacturing, reducing process difficulty, and provides a transition in hardness to prevent bending.

[0071] The bending process of the bidirectional adjustable sheath in this embodiment is as follows: Figure 6As shown, when the bending section 12 bends towards the first direction A, because the hardness of the A side of the joint is high (A side is 72DPEBAX pipe), it is more difficult to bend towards A. Therefore, when bending towards A, the starting point of the bending section 12 begins from the first starting point a. When the bending section 12 bends towards the second direction B, because the hardness of the B side of the joint is low (B side is 35DPEBAX pipe), it is easier to bend towards B. Therefore, when bending towards B, the starting point of the bending section 12 begins from the second starting point b. Thus, the design features different bending starting points and different bending radius lengths are formed, thereby achieving an asymmetrical bidirectional bending effect of the bidirectional adjustable bending sheath with different bending starting points and bending radii.

[0072] Example 2

[0073] Reference Figure 12 and Figure 13 Based on the overall design concept of the bidirectional adjustable bending sheath described above, this embodiment exemplifies another specific implementation of a bidirectional adjustable bending sheath. As shown in the figure, the bidirectional adjustable bending sheath of this embodiment includes a tube body 10 and a reinforcing tube 30. The tube body 10 includes a main body segment 11 and an adjustable bending segment 12 coaxially connected to the distal end of the main body segment 11. The adjustable bending segment 12 and the main body segment 11 are coaxially connected, sharing a common axis X. The reinforcing tube 30 is sleeved with the adjustable bending segment 12 of the tube body 10. See also... Figure 14 As shown, the reinforcing tube 30 includes a first part 31 and a second part 32 that are radially joined. The reinforcing strength of the first part 31 is lower than that of the second part 32, causing the starting point and bending radius of the bend towards the first direction A to be different from those of the bend towards the second direction B. The arrangement of reinforcing tubes with different reinforcing strengths results in two different bending starting points and bending radii along the axial direction of the reinforcing tube. The configuration of the TIP head 13 and the traction structure in this embodiment can be referred to the foregoing description, which refers to the overall design concept of the bidirectional adjustable bending sheath (the same applies below). This embodiment mainly provides a detailed example of the structure for achieving asymmetrical bending in the tube body 10 of the sheath.

[0074] Preferably, to ensure the sheath's support strength and effective bending, the hardness of the bending section 12 is lower than that of the main body section 11. The specific selection of hardness can also refer to the foregoing.

[0075] For example, such as Figure 12As shown, the tube body 10 includes an inner tube 10a, a middle tube 10b, and an outer tube (not shown) from the inside out. In this embodiment, the tube body 10 includes a TIP head 13 and a bidirectional adjustable bending sheath with a traction structure located inside the tube body 10. That is, the bidirectional adjustable bending sheath of this embodiment includes a tube body 10 and a traction structure. The tube body 10 includes a TIP head 13, an adjusting section 12, and a main body section 11 connected axially from far to near. The traction structure includes a traction ring 22 and two traction wires 21.

[0076] Specifically, refer to Figure 12 The inner tube 10a is a PTFE tube, the middle tube 10b is a spring tube or braided mesh tube, and the outer tube is an outer polymer tube. The PTFE tube is located at the innermost layer of the sheath, extending throughout the entire tube body 10 and providing a smooth inner cavity for the sheath, facilitating the transport of other instruments. The traction ring 22 is made of stainless steel and is located at the sheath tip 13, fitted over the outer wall of the PTFE tube and encased in the 72DPEBAX tube at the tip. The traction wire 21 is made of stainless steel and consists of two symmetrically distributed wires, which are welded to the traction ring 22 respectively. It is located between the outer wall of the PTFE tube and the inner wall of the middle tube 10b. The traction wire 21 extends from the end of the sheath tip 13 to the end of the main body section 11. The end of the traction wire 21 is connected to the bending mechanism of the handle. By adjusting the bending mechanism of the handle, the traction wire 21 can be pulled. The traction wire 21 transmits the tension to the traction ring 22. Because the hardness of the bending section 12 is lower than that of the main body section 11, the bending section 12 bends after being subjected to force on one side, while the main body section 11 does not bend, thereby achieving the effect of bending the distal end of the sheath.

[0077] The middle layer, consisting of a spring tube or braided mesh tube, is made of stainless steel. When it is a spring tube, it is spiral-shaped. When it is a braided mesh tube, it is woven from stainless steel wire. The spiral spring tube or braided mesh extends from the bending section 12 to the end of the main body section 11, fitting over the outer wall of the inner PTFE tube and the traction wire, and encasing the outer polymer tube, thus reinforcing the sheath. In this embodiment, the middle layer tube 10b is a braided mesh tube.

[0078] Combination Figure 13 and Figure 14 As shown, the reinforcing tube 30 is sleeved with the bending section 12 of the tube body 10. The reinforcing tube 30 is made of stainless steel or nickel-titanium alloy and is located near the end of the bending section 12. The sleeved connection between the reinforcing tube 30 and the bending section 12 of the tube body 10 includes, but is not limited to, being located on the inner wall of the inner tube 10a of the tube body 10, or sleeved between the inner tube 10a and the middle tube 10b, or between the middle tube 10b and the outer tube, or on the outer wall of the outer tube. In this embodiment, it is illustrated that the reinforcing tube 30 is sleeved between the middle tube 10b and the outer tube of the bending section.

[0079] Specifically, refer toFigure 14 The reinforcing tube 30 is configured with a first portion 31 and a second portion 32, each half of which is provided. Two reinforcing ribs are formed axially at the connection between the first portion 31 and the second portion 32. To reduce the support strength of the first portion 31, a first circumferential cut 31a with a first axial width W1 is provided in the first portion 31. Furthermore, to enhance the connection strength between the reinforcing tube 30 and the tube body 10, a second circumferential cut 32a with a second axial width W2 is provided in the second portion 32. During the welding process, other parts of the tube body 10 can extend into the second cut 32a, thereby increasing the connection strength. At this time, to further ensure the support strength of the second portion 32, the second axial width W2 of the second cut 32a is smaller than the first axial width W1 of the first cut, resulting in a longer axial length of the second reinforcing rib formed between the two second cuts in the second portion 32, thus providing better support strength.

[0080] The bending process of the bidirectional adjustable sheath in this embodiment is as follows: Figure 13 As shown, when the bending segment 12 bends towards side A, because the width of the cut on side A of the reinforcing tube 30 in the first direction is smaller, or in other words, the strength of the circumferential reinforcing rib on side A is greater, the area where the reinforcing tube 30 is located is more difficult to bend towards side A. Therefore, when bending towards side A, the starting point of the bending segment 12 begins from the first starting point a. When the bending segment 12 bends towards the second direction B, because the width of the cut on side B of the reinforcing tube 30 in the second direction is larger, or in other words, the strength of the circumferential reinforcing rib on side B is smaller, the area where the reinforcing tube 30 is located is easier to bend towards side B. Therefore, when bending towards side B, the starting point of the bending segment 12 begins from the second starting point b. Due to the different starting points, the bending radii are different. Thus, a design feature of different bending starting points and different bending radius lengths is formed, thereby achieving an asymmetrical bidirectional bending effect of the bidirectional adjustable bending sheath with different bending starting points and bending radii.

[0081] Example 3

[0082] Reference Figure 15 and Figure 16This embodiment is largely the same as Embodiment 2, with the same design concept for the reinforcing tube 30. The only difference is that the first part 31 and the second part 32 of the reinforcing tube 30 are not symmetrically arranged. The first part 31 has a larger circumferential proportion than the second part 32, so that the first part 31 does not contain the two reinforcing ribs formed axially at the connection between the first part 31 and the second part 32. The two reinforcing ribs formed axially are located within the second part 32. This method reduces the reinforcing strength of the first part 31 while enhancing the supporting strength of the second part 32. In addition, the first axial width W1 of the first cut 31a on the circumferential direction of the first part 31 is relatively large, resulting in only three spaced second reinforcing ribs on the first part 31 in the axial direction, further reducing the reinforcing strength of the first part 31. On the other hand, the second axial width W2 of the second cut 32a on the second part 32 is as small as possible, and the second cut 32a is spaced apart axially, which enhances the connection strength while ensuring the supporting strength as much as possible. For other structures besides the reinforcing tube 30, please refer to Embodiment 2, and will not be described again.

[0083] The bending process of the bidirectional adjustable sheath in this embodiment is as follows: Figure 16 As shown, when the bending section bends towards side A, because the strength of the reinforcing tube 30 is greater in the first direction A, the area where the reinforcing tube 30 is located is more difficult to bend towards side A. Therefore, when bending towards side A, the starting point of the bending section begins from the first starting point a. When the bending section bends towards the second direction B, because the strength of the reinforcing tube is less in the B direction, the area where the reinforcing tube is located is easier to bend towards side B. Therefore, when bending towards side B, the starting point of the bending section begins from the second starting point b. Thus, the design features different bending starting points and different bending section lengths are formed, thereby achieving the bidirectional bending effect of the bidirectional adjustable bending sheath with different bending radii.

[0084] Example 4

[0085] This embodiment is largely the same as the scheme of Embodiment 2. The difference lies in the specific structure of the reinforcing tube 30. For other structures besides the reinforcing tube 30, please refer to Embodiment 2, and will not be repeated here.

[0086] Reference Figure 17 and Figure 18 In this embodiment, the distal end of the reinforcing tube 30 is wedge-shaped and inclined relative to its axis, so that the reinforcing tube has a distal wedge-shaped opening 30a1. The reinforcing tube 30 with the distal wedge-shaped opening 30a1 is sleeved with the bending section 12 of the tube body 10. The principle and process of achieving asymmetrical bending with the wedge shape can be referred to in Embodiment 1, and will not be elaborated here. Further, see... Figure 17To enhance the connection strength between the reinforcing tube 30 and the tube body 10, the body 30a of the reinforcing tube 30 is provided with a third slit 30a2 in the circumferential direction. The circumferential arc length of the third slit 30a2 decreases sequentially from the proximal end to the distal end of the reinforcing tube 30. Preferably, to ensure both connection strength and the support strength of the body 30a of the reinforcing tube 30, the third slit 30a2 includes a first sub-slit 30a21 and a second sub-slit 30a22 spaced apart in the circumferential direction. An axially extending reinforcing portion is formed between the first sub-slit 30a21 and the second sub-slit 30a22 spaced apart in the circumferential direction. The first sub-slit 30a21 and the second sub-slit 30a22 located on both sides of the reinforcing portion are mirror images of each other. The sub-slits effectively ensure the connection strength, while the axially extending reinforcing portion between the sub-slits ensures the support strength.

[0087] The bending process of the bidirectional adjustable sheath in this embodiment is as follows: Figure 18 As shown, when the bending section bends towards side A, because the strength of the reinforcing tube A is greater in the first direction A, the area where the reinforcing tube is located is more difficult to bend towards side A. Therefore, when bending towards side A, the starting point of the bending section begins from the first starting point a. When the bending section bends towards the second direction B, because the strength of the reinforcing tube B is less, the area where the reinforcing tube is located is easier to bend towards side B. Therefore, when bending towards side B, the starting point of the bending section begins from the second starting point b. Thus, the design features different bending starting points and different bending section lengths are formed, thereby achieving the bidirectional bending effect of the bidirectional adjustable bending sheath with different bending radii.

[0088] Example 5

[0089] Based on the above embodiments 1 to 4, this embodiment proposes an interventional device, which includes a handle, a bending adjustment mechanism disposed in the handle, and a bidirectional adjustable bending sheath as described in any of the above embodiments 1 to 4. The bending adjustment mechanism is connected to the distal end of the tube body of the bidirectional adjustable bending sheath through a traction wire, so that the tube body can be bent in a first direction and a second direction respectively under the drive of the bending adjustment mechanism.

[0090] The bidirectional adjustable bending sheath and interventional device of this invention achieves the effect of different bending starting points and bending radii during bidirectional bending by adjusting the stiffness of the two sides of the bending section. Therefore, when the bidirectional adjustable bending sheath is applied in clinical scenarios where the openings of the two branch vessels are not at the same height or at different distances from the sheath body, the bidirectional adjustable bending sheath and interventional device of this invention can more quickly and accurately select the two branch vessels. Furthermore, during the selection process to enter a branch vessel, if the angle of one bending side is unsuitable, the other bending side can be immediately adjusted for operation, making operation convenient and improving the applicability of the product.

[0091] The technical features of the above embodiments can be combined in any way. For the sake of brevity, 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, they should be considered to be within the scope of this specification.

[0092] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A bidirectional adjustable bendable sheath, characterized in that, The tube includes a main body segment and a bending segment coaxially connected to the distal end of the main body segment. The bending segment can be bent in a first direction and in a second direction, respectively. The first starting point and the first bending radius of the bending in the first direction are different from the second starting point and the second bending radius of the bending in the second direction. The bidirectional adjustable bending sheath is configured such that: the hardness of the bending section is less than that of the main body section; at least a portion of the layers at the interface between the main body section and the bending section are wedge-shaped and inclined relative to the axis, such that the connection between the main body section and at least a portion of the layers of the bending section is a wedge-shaped connection; wherein, the wedge shape allows the bending section and the main body section, which have different hardnesses, to form a wedge-shaped transition at the connection point, creating two different bending starting points and bending radii axially; and / or The bidirectional adjustable bending sheath is configured such that: the bidirectional adjustable bending sheath further includes a reinforcing tube sleeved with the bending section of the tube body, the reinforcing tube being used to adjust the hardness of the first direction and the second direction on the bending section; the reinforcing tube includes a first part and a second part that are radially joined, the reinforcing strength of the first part being lower than the reinforcing strength of the second part, such that the starting point and bending radius of the bending toward the first direction are different from the starting point and bending radius of the bending toward the second direction.

2. The bidirectional adjustable bendable sheath according to claim 1, characterized in that, The tube body comprises an inner tube, a middle tube, and an outer tube from the inside out; the inner tube and / or the middle tube and / or the outer tube at the interface of the main body section are wedge-shaped and inclined relative to their axis; the layer at the interface of the bending section that is opposite to the wedge-shaped layer of the main body section is wedge-shaped and matches the wedge-shaped layer of the main body section.

3. The bidirectional adjustable bendable sheath according to claim 1, characterized in that, The first part has a first cut with a first axial width in the circumferential direction.

4. The bidirectional adjustable bendable sheath according to claim 3, characterized in that, The second part has a second cut with a second axial width in the circumferential direction, and the axial width of the second cut is smaller than the first axial width of the first cut.

5. The bidirectional adjustable bendable sheath according to claim 1, characterized in that, The distal end of the reinforcing tube is wedge-shaped and inclined relative to its axis, so that the reinforcing tube has a distal wedge-shaped opening.

6. The bidirectional adjustable bendable sheath according to claim 5, characterized in that, The reinforcing tube has a third circumferential cut, the circumferential arc length of which decreases sequentially from the proximal end to the distal end of the reinforcing tube.

7. The bidirectional adjustable bendable sheath according to claim 6, characterized in that, The third incision includes a first sub-incision and a second sub-incision spaced apart circumferentially, and an axially extending reinforcing portion is formed between the first sub-incision and the second sub-incision spaced apart circumferentially, with the first sub-incision and the second sub-incision located on both sides of the reinforcing portion mirror-facing each other.

8. The bidirectional adjustable bendable sheath according to claim 1, characterized in that, The tube body comprises an inner tube, a middle tube, and an outer tube from the inside out, and the reinforcing tube is sleeved between the middle tube and the outer tube at the proximal end of the bending section.

9. The bidirectional adjustable bendable sheath according to any one of claims 1 to 8, characterized in that, It also includes development marks disposed on the tube body, the development marks including a first local mark and a second local mark disposed locally along the circumference of the tube body, the first local mark and the second local mark having the first starting point and the second starting point as their starting ends respectively, and the extension directions of the first local mark and the second local mark being opposite to each other.

10. The bidirectional adjustable bendable sheath according to claim 9, characterized in that, The arc lengths of the first local mark and the second local mark on the tube body are each less than or equal to one-quarter of the tube body circumference.

11. The bidirectional adjustable bendable sheath according to claim 9, characterized in that, When at least a portion of the layers at the interface between the main body section and the bending section are wedge-shaped and inclined relative to the axis, such that the connection between the main body section and at least a portion of the layers of the bending section is a wedge-shaped connection, the developing mark further includes a first wedge mark and a second wedge mark partially disposed on the tube body along the contour trajectory of the interface. The first wedge mark and the second wedge mark are respectively starting from the first starting point and the second starting point, and the extension directions of the first wedge mark and the second wedge mark are opposite to each other.

12. The bidirectional adjustable bendable sheath according to claim 1, characterized in that, The tube body also includes a TIP head coaxially connected to the distal end of the bending section, and the bidirectional adjustable bending sheath also includes a traction ring connected to the TIP head and a traction wire connected to the traction ring at its distal end.

13. An interventional device, characterized in that, The device includes a handle, a bending mechanism disposed within the handle, and a bidirectional adjustable bending sheath as described in any one of claims 1 to 12. The bending mechanism is connected to the bending section of the bidirectional adjustable bending sheath via a traction wire, such that the bending section can be bent in a first direction and a second direction respectively under the drive of the bending mechanism.

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