An adjustable bend delivery system

Abstract

The present application relates to a kind of adjustable bending delivery system for delivering implant into human body, the adjustable bending delivery system includes conveyor and bending device, the conveyor includes delivery sheath tube, the bending device includes bending sheath tube, the bending sheath tube distal end can be bent to make the bending device distal end be bent, the delivery sheath tube distal end can be accessed into human body from the artery on one leg, the bending device distal end can be accessed into human body from the artery on another leg, when the delivery sheath tube and the bending device distal end are pushed to abdominal aorta, the delivery sheath tube and the bending device distal end can cooperate in abdominal aorta, so that the bending sheath tube can drive the delivery sheath tube to be bent after bending.The adjustable bending delivery system provided by the present application requires smaller bending force, higher bending sensitivity, more stable bending process, more accurate bending direction, and better overall bending effect.

Description

Technical Field

[0001] This invention relates to the field of interventional medicine, and more specifically to an adjustable bendable delivery system. Background Technology

[0002] Valvular disease in the elderly and valvular lesions caused by coronary heart disease and myocardial infarction are becoming increasingly common. These valvular lesions not only endanger life and affect quality of life, but also place a heavy burden and pressure on families and society. The human heart contains four chambers: the left atrium, left ventricle, right atrium, and right ventricle. The two atria are connected to the two ventricles through the mitral and tricuspid valves, respectively, and the two ventricles are connected to the two aortas. Heart valves grow between the atria and ventricles, and between the ventricles and aortas, acting as one-way valves to help blood flow in one direction. The four valves in the human body are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. If these valves become diseased, usually through stenosis or insufficiency, they will hinder normal blood flow, increase the corresponding burden on the heart, thereby causing damage to normal heart function, leading to heart failure and changes in the function of multiple organs.

[0003] Currently, the main surgical treatment for valvular heart disease is valve replacement surgery, which replaces the diseased heart valve with an artificial mechanical valve or a bioprosthetic valve. In transcatheter aortic valve replacement (TAVCR), the catheter needs to traverse the tortuous aortic arch to reach the aortic valve lesion. Therefore, the catheter needs to be bent to ensure smooth access to the lesion. However, existing catheters are bent by pulling on a bending wire attached to the catheter. This increases the catheter's size, reduces the internal space for medical devices, and limits its application. Furthermore, bending via the bending wire requires significant force, making precise control difficult and resulting in low bending sensitivity and unsatisfactory bending effects. Moreover, catheters bent using the bending wire have a limited bending angle, further restricting their applicability. Summary of the Invention

[0004] To overcome the problems existing in the prior art, the present invention provides an adjustable bending conveyor system.

[0005] The present invention provides an adjustable bending delivery system for delivering implants into the human body. The adjustable bending delivery system includes a delivery device and an adjusting device. The delivery device includes a delivery sheath, and the adjusting device includes an adjusting sheath. The distal end of the adjusting sheath can be bent, thereby causing the distal end of the adjusting device to bend. The distal end of the delivery sheath can enter the human body through an artery in one leg, and the distal end of the adjusting device can enter the human body through an artery in the other leg. When the delivery sheath and the distal end of the adjusting device are pushed into the abdominal aorta, the delivery sheath and the distal end of the adjusting device can cooperate within the abdominal aorta, thereby causing the adjusting sheath to bend and thus driving the delivery sheath to bend as well.

[0006] In some embodiments of the present invention, the bending device further includes a mating component, the mating component having a hollow structure with a receiving cavity, one end of the mating component being connected to the distal end of the bending sheath, when the conveying sheath mates with the bending sheath, the distal end of the conveying sheath can be housed in the receiving cavity, and after the bending sheath bends, it drives the mating component to move, and the movement of the mating component drives the conveying sheath to bend.

[0007] In some embodiments of the present invention, the mating component includes a main body and a gathering portion located at the distal end of the main body. The main body includes a cylindrical structure, and the gathering portion includes a conical structure. One end of the main body is connected to the distal end of the bending sheath, and the other end of the main body is connected to the gathering portion. The diameter of the gathering portion gradually decreases from the proximal end to the distal end. When the delivery sheath mates with the bending sheath, the distal end of the delivery sheath is housed within the gathering portion.

[0008] In some embodiments of the present invention, the gathering portion includes a plurality of gathering petals, one end of the plurality of gathering petals is disposed at a distance from each other at the far end of the main body, and the other end of the plurality of gathering petals gathers together and approaches each other towards the far end.

[0009] In some embodiments of the present invention, a first opening is provided on the side wall of the mating member, and the first opening is connected to the receiving cavity.

[0010] In some embodiments of the present invention, the bending sheath includes an inner tube and an outer tube, the outer tube being sleeved on the inner tube, and the distal ends of both the inner tube and the outer tube being connected to the proximal end of the mating member. A second opening is provided on the side of the distal end of the outer tube. When the inner tube is pushed to the distal end, the distal end of the inner tube bends and passes through the second opening to protrude outside the outer tube. The bent distal end of the inner tube can drive the mating member to move.

[0011] In some embodiments of the present invention, the proximal end of the mating member is provided with a hinge portion, the distal end of the outer tube is rotatably connected to the hinge portion, the distal end of the inner tube is fixedly connected to the proximal end of the mating member, and when the inner tube is pushed to the distal end, the inner tube bends, thereby causing the mating member to rotate around the hinge portion.

[0012] In some embodiments of the present invention, the outer tube and / or the inner tube are provided with two first cavities and two first supports, with one first support disposed in one of the first cavities.

[0013] In some embodiments of the present invention, the inner tube includes a body tube, an inner liner tube, and a braided layer, the braided layer being sleeved on the inner liner tube, the body tube being sleeved on the braided layer, and the first cavity being disposed inside the body tube.

[0014] In some embodiments of the present invention, the conveyor further includes a conveying handle, the bending device further includes a bending handle, the bending handle includes a handle body and a pusher, the pusher is slidably connected to the handle body, the proximal end of the conveying sheath is housed in the conveying handle, the proximal end of the bending sheath is housed in the bending handle, and the proximal end of the inner tube is connected to the pusher, the movement of the pusher can drive the inner tube to move relative to the outer tube.

[0015] Compared with existing technologies, the adjustable bending delivery system of the present invention has the following advantages: The adjustable bending delivery system of the present invention separates the bending device for bending the delivery sheath from the delivery device itself, allowing them to enter the body separately. This eliminates the need to house the traction wire for bending within the delivery sheath, resulting in a larger internal space and making the delivery device suitable for a wider range of medical devices of different sizes and specifications, thus broadening its application scope. Simultaneously, the present invention requires less force for bending, allowing for easy bending of the delivery sheath. This results in higher bending sensitivity, a larger adjustable bending angle, and better control and precision of the bent angle. Furthermore, the lower force required for bending facilitates operation by the physician, avoiding errors caused by excessive force and preventing the adjustable bending delivery system from shaking, which could lead to medical accidents or affect surgical outcomes. Attached Figure Description

[0016] Figure 1 This is a three-dimensional structural diagram of the adjustable bending conveyor system provided in the first embodiment of the present invention.

[0017] Figure 2 This is a schematic diagram of the adjustable bending conveying system provided in the first embodiment of the present invention when it is used in the human body.

[0018] Figure 3 This is a schematic diagram of the adjustable bending conveying system provided in the first embodiment of the present invention, used for conveying and bending within the human body.

[0019] Figure 4 This is a schematic diagram of the adjustable bending conveying system provided in the first embodiment of the present invention when it completes bending within the human body.

[0020] Figure 5 This is a three-dimensional structural diagram of the adjustable bending sheath and its fittings of the adjustable bending conveying system provided in the first embodiment of the present invention.

[0021] Figure 6 This is a three-dimensional structural diagram of the conveying sheath of the adjustable bending conveying system provided in the first embodiment of the present invention.

[0022] Figure 7 This is a schematic diagram of the inner and outer tube structures of the adjustable bending conveying system provided in the first embodiment of the present invention.

[0023] Figure 8 This is a cross-sectional structural diagram of the inner or outer tube of the adjustable bending conveying system provided in the first embodiment of the present invention.

[0024] Figure 9 This is a schematic diagram of the separation structure of the inner or outer tube of an adjustable bending conveying system provided in another embodiment of the present invention.

[0025] Figure 10 This is a three-dimensional structural diagram of the adjustable bending conveyor system provided in the second embodiment of the present invention.

[0026] Figure 11 This is a schematic diagram of the adjustable bending sheath and its fittings in the adjustable bending conveying system provided in the second embodiment of the present invention.

[0027] Figure 12 This is a schematic diagram of the retraction structure of the adjustable sheath and fittings of the adjustable conveying system provided in the second embodiment of the present invention.

[0028] Figure 13 This is a three-dimensional structural diagram of the adjustable bending conveyor system provided in the third embodiment of the present invention.

[0029] Figure 14 This is a schematic diagram of the adjustable sheath and fittings of the adjustable conveying system provided in the third embodiment of the present invention.

[0030] Figure 15 This is a three-dimensional structural diagram of the adjustable bending conveyor system provided in the fourth embodiment of the present invention.

[0031] Figure 16 This is a schematic diagram of the cross-sectional structure of the inner tube of the adjustable bending conveying system provided in the fourth embodiment of the present invention.

[0032] Figure 17 This is a schematic cross-sectional view of the adjustable sheath structure of the adjustable conveying system provided in other embodiments of the present invention.

[0033] Explanation of reference numerals in the attached diagram: 100, Adjustable bending conveyor system; 1, Conveyor; 2, Bending device; 11, Conveying sheath; 12, Conveying handle; 21, Bending sheath; 22, Fitting component; 221, Receiving cavity; 111, Outer sheath; 112, Inner core tube; 113, Tip head; 114, Loading section; 222, First opening; 211, Inner tube; 212, Outer tube; 2121, Second opening; 231, Inner layer; 232, Intermediate layer; 233, Outer layer; 2122, First cavity; 2123, First support component; 23, Bending handle; 200, Adjustable bending conveyor system; 22' Mating component; 223, Main body; 224, Gathering part; 21', Adjustable bending sheath; 11', Conveying sheath; 2241, Gathering leaf; 113', Tip head; 300, Adjustable bending conveying system; 32, Mating component; 321, Hinge; 34, Outer tube; 33, Inner tube; 3211, Fixing part; 3212, Rotating shaft; 400, Adjustable bending conveying system; 411, Inner tube; 4111, Main body tube; 4112, First support component; 4113, First cavity; 412, Outer tube; 41, Adjustable bending sheath; 4114, Inner liner tube; 4115, Braided layer. Detailed Implementation

[0034] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention 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 the invention and to fully convey the scope of the invention to those skilled in the art.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator during the surgical procedure, "proximal" refers to the end closest to the operator during the surgical procedure, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial".

[0039] Please see Figure 1The first embodiment of this invention provides an adjustable delivery system 100 for delivering medical devices to be implanted in the human body to the lesion site. It is particularly suitable for transcatheter aortic valve replacement surgery, and can also be used in surgeries involving the mitral, tricuspid, pulmonary valves, and coronary artery bypass grafting. This invention uses the adjustable delivery system 100 for transcatheter aortic valve replacement surgery as an example for detailed explanation. The adjustable delivery system 100 includes a delivery device 1 and an adjusting device 2. The delivery device 1 includes a delivery sheath 11, and the adjusting device 2 includes an adjusting sheath 21. The delivery sheath 11 can load the aortic valve device and deliver it to the lesion site. The adjusting device 2 is used to adjust the curvature of the delivery sheath 11. Specifically, the delivery sheath 11 can enter the human body through an artery in the left leg or the right leg; correspondingly, the distal end of the adjusting device 2 can enter the human body through an artery in the right leg or the left leg. When the delivery sheath 11 and the distal end of the bending device 2 are pushed into the abdominal aorta, the delivery sheath 11 and the distal end of the bending device 2 can engage within the abdominal aorta. Simultaneously, the distal end of the bending sheath 21 can be bent, thereby causing the distal end of the bending device 2 to bend as well. Therefore, when the delivery sheath 11 and the distal end of the bending device 2 engage within the common iliac artery, the bending of the bending sheath 21 can cause the delivery sheath 11 to bend, thus completing the bending of the delivery sheath 11.

[0040] It is understood that in the first embodiment of the present invention, the arteries on the left leg and the right leg can be the femoral artery, the external iliac artery, or the common iliac artery. That is, the delivery sheath 11 can enter the body from the femoral artery, external iliac artery, or common iliac artery on the left leg, while the distal end of the bending device 2 enters the body from the femoral artery, external iliac artery, or common iliac artery on the right leg. After the distal ends of the delivery sheath 11 and the bending device 2 enter the body, they are pushed forward towards the abdominal aorta until their distal ends reach the abdominal aorta. Because the abdominal aorta has a large space, the delivery sheath 11 and the bending device 2 can cooperate within the abdominal aorta, such as... Figure 2As shown. After the delivery sheath 11 and the bending device 2 are engaged, they are simultaneously pushed forward towards the aortic arch. When the delivery sheath 11 and the bending device 2 approach the aortic arch, the distal end of the bending sheath 21 can be bent, thereby adjusting the angle of the distal ends of the delivery sheath 11 and the bending device 2. This allows the distal ends of the delivery sheath 11 and the bending device 2 to smoothly enter the aortic arch. Subsequently, by continuously adjusting the angle of the distal ends of the delivery sheath 11 and the bending device 2, they smoothly pass through the aortic arch and reach the location of the aortic valve lesion, as shown. Figure 3 As shown.

[0041] This invention separates the bending device 2 for adjusting the delivery sheath 11 from the delivery device 1, allowing them to enter the human body separately. This eliminates the need to house the bending traction wire inside the delivery sheath 11, resulting in a larger internal space. Consequently, the delivery device 1 can be used with a wider range of medical devices of different sizes, broadening its application scope.

[0042] Please combine Figure 1 and Figure 5 The bending device 2 further includes a mating component 22. In the first embodiment of the present invention, the mating component 22 is a cylindrical structure and includes a hollow structure with a receiving cavity 221. The shape of the receiving cavity 221 corresponds to the shape of the conveying sheath 11, and the size of the receiving cavity 221 is larger than the size of the conveying sheath 11. One end of the mating component 22 is connected to the distal end of the bending sheath 21, and the other end of the mating component 22 is a free end. When the conveying sheath 11 is mated with the bending device 2, the distal end of the conveying sheath 11 can be housed in the receiving cavity 221, that is, the mating component 22 is mated with the distal end of the conveying sheath 11. After the bending sheath 21 is bent, it causes the mating component 22 to deflect and thus move. The deflection of the mating component 22 will cause the conveying sheath 11 to bend.

[0043] The receiving cavity 221 extends from the distal end to the proximal end of the mating member 22. When the mating member 22 is mated with the delivery sheath 11, the proximal end of the mating member 22 faces the distal end of the delivery sheath 11, as shown below. Figure 1 As shown. The bending sheath 21 can then be retracted or the delivery sheath 11 can be pushed, allowing the delivery sheath 11 to enter the receiving cavity 221, thereby completing the engagement between the delivery sheath 11 and the mating member 22. After the delivery sheath 11 and the mating member 22 have engaged, the mating member 22 can move along the length of the delivery sheath 11.

[0044] Further, please refer to Figure 5 and Figure 6 In the first embodiment of the present invention, the delivery sheath 11 includes an outer sheath 111, an inner core tube 112, and a tip head 113. The distal end of the inner core tube 112 is connected to the tip head 113. The outer sheath 111 is sleeved on the inner core tube 112 and is coaxially arranged with the inner core tube 112. The outer sheath 111 is axially movable relative to the inner core tube 112. The proximal end face of the tip head 113, the outer surface of the distal end of the inner core tube 112, and the inner surface of the distal end of the outer sheath 111 together define a loading section 114. That is, the loading section 114 is located at the distal end of the delivery sheath 11, and the aortic valve device is mounted on the loading section 114. The mating member 22 mates with the outer sheath 111 at the location of the loading section 114. When the delivery sheath 11 reaches the aortic valve lesion, the outer sheath 111 is retracted, exposing the loading section 114 outside the outer sheath 111, thereby allowing the aortic valve device mounted on the loading section 114 to expand and release. Simultaneously, to prevent the bending device 2 from obstructing the release of the aortic valve device, the bending sheath 21 can be retracted sequentially before releasing the aortic valve device, moving the fitting 22 away from the loading section 114, thus preventing the fitting 22 from obstructing the release of the aortic valve device. Furthermore, to ensure the bending effect of the bending device 2 and to prevent the distal end of the delivery sheath 11 from not remaining bent before the aortic valve device is released, thus preventing the aortic valve device from being accurately released at the lesion location, the retraction of the outer sheath 111 and the retraction of the fitting 22 should be coordinated. Specifically, when releasing the aortic valve device, the outer sheath 111 can be withdrawn a short distance to release the distal end of the aortic valve device, anchoring it at the lesion site and ensuring accurate release. After the distal end of the aortic valve device is released, the mating member 22 can be withdrawn a short distance, followed by the outer sheath 111, to release the middle section of the aortic valve device. Then, the mating member 22 and the outer sheath 111 are withdrawn again until the aortic valve device is fully released. The delivery sheath 11 and the bending sheath 21 can then be withdrawn to the abdominal aorta. Finally, the mating member 22 and the outer sheath 111 are disconnected at the abdominal aorta, allowing the delivery device 1 and the bending device 2 to be withdrawn from the body.

[0045] Furthermore, before the bending device 2 enters the human body, the bending sheath 21 and fitting 22 of the bending device 2 need to be compressed and loaded into the catheter sheath (not shown). The bending sheath 21 and fitting 22 enter the human body along with the catheter sheath, and the catheter sheath transports the bending sheath 21 and fitting 22 to the abdominal aorta. Subsequently, the distal end of the bending sheath 21 and the fitting 22 can be released from the catheter sheath. Please continue reading. Figure 5 In the first embodiment of the present invention, to facilitate the compression of the fitting member 22 into the catheter sheath, a first opening 222 is provided on the side wall of the fitting member 22. The first opening 222 communicates with the receiving cavity 221, extending from the proximal end to the distal end of the fitting member 22, and is parallel to the axial direction of the fitting member 22. The first opening 222 allows the fitting member 22 to be compressed into the receiving cavity 221 during compression, thereby compressing the fitting member 22 into a smaller volume for easy loading into the catheter sheath. Meanwhile, to ensure the support and flexibility of the mating component 22, the mating component 22 has a certain degree of support to bend the delivery sheath 11 and a certain degree of flexibility to facilitate compression. The mating component 22 has a three-layer structure, namely, an inner layer, a middle layer, and an outer layer. The inner layer is made of polytetrafluoroethylene, the middle layer is made of nickel-titanium material, and the outer layer is made of PEBAX material. A hydrophilic coating is provided on the outer surface of the mating component 22.

[0046] In other specific embodiments of the present invention, the first opening 222 is also angled to the axial direction of the mating member 22 to facilitate helical compression of the mating member 22. The first opening 222 may also be a plurality of through slots provided on the sidewall of the mating member 22, with the through slots spaced apart along the circumferential direction of the mating member 22. Simultaneously, the multiple through slots may be arranged parallel to the axial direction of the mating member 22, or at an angle to the axial direction of the mating member 22.

[0047] Please see Figure 1 and Figure 7The bending sheath 21 includes an inner tube 211 and an outer tube 212. The outer tube 212 is sleeved on the inner tube 211. The distal ends of both the inner tube 211 and the outer tube 212 are connected to the proximal end of the mating member 22. A second opening 2121 is provided on the side of the distal end of the outer tube 212. When the inner tube 211 is pushed distally, the distal end of the inner tube 211 bends and passes through the second opening 2121, protruding outside the outer tube 212. The bent distal end of the inner tube 211 can drive the mating member 22 to move, and the movement of the mating member 22 in turn causes the delivery sheath 11 to bend. Specifically, the distal ends of both the inner tube 211 and the outer tube 212 are fixedly connected to the proximal end of the mating member 22. When it is necessary to bend the delivery sheath 11, the outer tube 212 is first stabilized to prevent axial movement of the outer tube 212. Subsequently, pushing the inner tube 211 causes it to move towards the mating member 22 and bend. The bent portion of the inner tube 211 protrudes through the second opening 2121 outside the outer tube 212. Since the outer tube 212 is in a stable state, it will not be moved along with the inner tube 211. Therefore, when the inner tube 211 is pushed, the bending sheath 21 will not move axially to prevent the mating member 22 from slipping off the delivery sheath 11. Simultaneously, the bending of the inner tube 211 will cause the mating member 22 to move, which in turn will cause the delivery sheath 11 to bend, thus completing the bending of the delivery sheath 11.

[0048] It is understandable that bending the delivery sheath 11 by pushing the inner tube 211 requires less pushing force, meaning less force is needed for bending. This allows for easy bending of the delivery sheath 11, resulting in higher bending sensitivity of the inner tube 211, a larger adjustable bending angle, and better control and precision of the bent angle. Simultaneously, the lower bending force facilitates operation by the doctor, avoiding errors caused by excessive bending force, and preventing the adjustable delivery system 100 from shaking due to excessive bending force, which could lead to medical accidents or affect surgical outcomes.

[0049] Please see Figure 7 - Figure 9In the first embodiment of the present invention, both the inner tube 211 and the outer tube 212 include an inner layer 231, a middle layer 232, and an outer layer 233. The inner layer 231 is made of polytetrafluoroethylene (PTFE), the middle layer 232 is woven from nickel-titanium wire, and the outer layer 233 is made of PEBAX material. A hydrophilic coating is provided on the outer surface of the outer tube 212. Specifically, the inner layer 231 is a PTFE liner tube with good support properties, providing basic support for the inner tube 211 and the outer tube 212 as a whole. The middle layer 232 is a braided mesh tube made of nickel-titanium wire, which is sleeved on the inner layer 231 and fixed to the inner layer 231 by heat fusion. The intermediate layer 232 further enhances the support of the inner tube 211 and the outer tube 212, reducing the thrust required for bending the inner tube 211. Simultaneously, the intermediate layer 232 prevents the inner tube 211 and outer tube 212 from elongating under external stretching. The outer layer 233 is a tubular structure made of PEBAX material, fitted onto the intermediate layer 232 and fixed to the intermediate layer 232 and / or the inner layer 231 by heat fusion. The outer layer 233 improves the overall toughness and strength of the inner tube 211 or the outer tube 212. Furthermore, the PEBAX material of the outer layer 233 exhibits good biocompatibility. A hydrophilic coating is also applied to the outer surface of the outer layer 233, ensuring smooth movement of the inner tube 211 and outer tube 212 within the human body. The PEBAX material of the outer layer 233 also facilitates the application of the hydrophilic coating.

[0050] In other specific embodiments of the present invention, since the inner tube 211 only needs to perform two movements, pushing and rebounding, during the operation, the inner tube 211 is not stretched. Therefore, the intermediate layer 232 can be omitted from the inner tube 211, thereby further improving the flexibility of the inner tube 211 and making it easier for the inner tube 211 to bend.

[0051] For further information, please refer to [link / reference]. Figure 7 and Figure 8In the first embodiment of the present invention, two first cavities 2122 are provided within the outer layer 233 of the outer tube 212, and the two first cavities 2122 are symmetrically arranged in position. The outer tube 212 also includes two first support members 2123, which are made of 304 stainless steel and have a long strip structure. The two first support members 2123 are respectively housed within the two first cavities 2122. The first support members 2123 can restrict the bending direction of the outer tube 212. The first support members 2123 have a certain degree of support, so the outer tube 212 cannot be bent in the direction where the first support members 2123 are provided, and the outer tube 212 can only be bent in the direction where the first support members 2123 are not provided. In the first embodiment of the present invention, the first cavity 2122 is symmetrically arranged, and the first support member 2123 is arranged within the symmetrical first cavity 2122. This ensures that the bending sheath 21 can only be bent in two opposite directions without the first support member 2123, thus guaranteeing the directional bending of the bending sheath 21 and preventing the inability to determine the bending direction when bending is required. Simultaneously, the intermediate layer 232 protects the inner layer 231. When the bending sheath 21 bends, the first support member 2123 also bends. The intermediate layer 232 prevents the rebound force caused by the bending deformation of the first support member 2123 from being directly applied to the inner layer 231, thus avoiding damage to the inner layer 231. Furthermore, the outer tube 212 is not subject to external force from the user during bending, the outer tube 212 is less affected by external force, and the diameter of the outer tube 212 is relatively large, that is, the distance between the first support member 2123 and the central axis of the outer tube 212 is relatively far, that is, the moment of inertia is relatively large. Therefore, setting the first support member 2123 on the outer tube 212 is more conducive to controlling the bending direction.

[0052] In other specific embodiments of the present invention, the first cavity 2122 may also be disposed within the inner layer 231 of the outer tube 212. When the accuracy of the bending direction is not critical, the first cavity 2122 and the first support member 2123 may be omitted to ensure the flexibility of the sheath.

[0053] Please combine Figure 1 and Figure 7The delivery device 1 further includes a delivery handle 12, the proximal end of the delivery sheath 11 being housed within the delivery handle 12. The delivery handle 12 is used to control the release of the aortic valve device loaded within the delivery sheath 11. The delivery handle 12 is prior art and will not be described in detail here. The bending device 2 further includes a bending handle 23, which includes a handle body (not shown) and a pusher (not shown). The pusher is slidably connected to the handle body, and part of the pusher is housed within the handle body while part is exposed outside the handle body. The proximal end of the bending sheath 21 is housed within the bending handle, and the proximal end of the inner tube 211 is connected to the pusher. Movement of the pusher can cause the inner tube 211 to move relative to the outer tube 212. Specifically, the proximal end of the outer tube 212 can be fixed within the handle body to ensure that the outer tube 212 does not move axially relative to the handle body. When a bending operation is required, the pusher is pushed to move to the far end. The movement of the pusher causes the inner tube 211 to move to the far end. Since the far end of the inner tube 211 is fixed on the proximal end of the mating part 22, the inner tube 211 will bend, thereby realizing the bending of the delivery sheath 11.

[0054] Please see Figure 10 and Figure 11 The second embodiment of the present invention provides an adjustable bending conveyor system 200. The main difference between the adjustable bending conveyor system 200 and the adjustable bending conveyor system 100 of the first embodiment is that the mating component 22' further includes a main body 223 and a gathering portion 224 located at the distal end of the main body 223. The main body 223 has a cylindrical structure, and the gathering portion 224 has a conical structure. One end of the main body 223 is connected to the distal end of the adjusting sheath 21', and the other end of the main body 223 is connected to the gathering portion 224. The diameter of the gathering portion 224 gradually decreases from the proximal end to the distal end. When the conveying sheath 11' mates with the adjusting sheath 21', the distal end of the conveying sheath 11' is housed within the gathering portion 224. The gathering portion 224 includes a plurality of gathering petals 2241.

[0055] Specifically, the gathering portion 224 is composed of multiple gathering petals 2241, each petal having a triangular structure. The larger ends of the multiple gathering petals 2241 are spaced apart at the distal end of the main body 223, while the smaller ends converge towards each other, forming the gathering portion 224 whose diameter gradually decreases from the proximal end to the distal end. Furthermore, the gathering portion 224 comprises a three-layer structure: an inner layer, a middle layer, and an outer layer. The inner layer is made of polytetrafluoroethylene (PTFE), the middle layer is made of nickel-titanium alloy, and the outer layer is made of PEBAX. A hydrophilic coating is applied to the outer surface of the gathering portion 224, enabling it to possess support, flexibility, and smoothness. It is understood that, to prevent insufficient friction between the mating component 22' and the conveying sheath 11' during bending, which could cause the conveying sheath 11' to slide relative to the mating component 22' and thus prevent the conveying sheath 11' from being bent, the mating component 22' in the second embodiment of the present invention includes a gathering portion 224. The distal end of the conveying sheath 11' is housed within the gathering portion 224, that is, the gathering portion 224 limits the conveying sheath 11' and prevents the conveying sheath 11' from sliding towards its distal end. Meanwhile, the diameter of the converging portion 224 gradually decreases from the proximal end to the distal end, making the shape of the converging portion 224 similar to the shape of the tip head 113' of the delivery sheath 11'. This allows the tip head 113' to fit more tightly into the converging portion 224 when it is housed there, further ensuring the limiting effect of the converging portion 224 on the delivery sheath 11'. Furthermore, during the release of the aortic valve device, the bending sheath 21' needs to be retracted. Since the converging portion 224 is composed of multiple converging leaflets 2241 and is not a closed shape, and the converging leaflets 2241 have a certain degree of flexibility, this is because... Therefore, when the bending sheath 21' retracts, the converging leaflets 2241 deform, and the distal ends of the converging leaflets 2241 move away from each other, allowing the delivery sheath 11' to pass through the converging portion 224, thereby enabling the bending sheath 21' to retract relative to the delivery sheath 11'. Figure 12 As shown.

[0056] Please see Figure 13 and Figure 14The third embodiment of the present invention provides an adjustable bending conveyor system 300. The main difference between the adjustable bending conveyor system 300 and the adjustable bending conveyor system 100 of the first embodiment and the adjustable bending conveyor system 200 of the second embodiment is that: the proximal end of the mating member 32 is provided with a hinge portion 321, the distal end of the outer tube 34 is rotatably connected to the hinge portion 321, and the distal end of the inner tube 33 is fixedly connected to the proximal end of the mating member 32. When the inner tube 33 is pushed to the distal end, the inner tube 33 bends, thereby causing the mating member 32 to rotate around the hinge portion 321. Specifically, the hinge portion 321 includes a fixed portion 3211 fixedly connected to the mating member 32 and a rotating shaft 3212 mounted on the fixed portion 3211. The rotating shaft 3212 can rotate relative to the fixed portion 3211, and the distal end of the outer tube 34 is connected to the rotating shaft 3212. When the inner tube 33 is pushed, it bends, causing the mating component 32 to rotate around the rotation axis 3212. The hinge portion 321 makes the process of the inner tube 33 bending and the mating component 32 rotating smoother. Simultaneously, the hinge portion 321 allows the rotation axis and radius of the mating component 32 to be determined, resulting in more accurate and precise bending of the adjustable bending conveyor system 300.

[0057] It is understood that a damping structure (not shown) can be provided between the rotating shaft 3212 and the fixed part 3211, so that the mating part 32 needs to overcome a certain resistance when rotating through the rotating shaft 3212, thereby allowing the mating part 32 to maintain a certain angle after bending, and avoiding the influence of the sheath's rebound force on the mating part 32, which would affect the bending effect.

[0058] Please see Figure 15 and Figure 16The fourth embodiment of the present invention provides an adjustable bending conveyor system 400. The main difference between this adjustable bending conveyor system 400 and the adjustable bending conveyor system 100 of the first embodiment, the adjustable bending conveyor system 200 of the second embodiment, and the adjustable bending conveyor system 300 of the third embodiment is that the inner tube 411 includes a body tube 4111 and a first support member 4112. The body tube 4111 is made of nylon material, and the first support member 4112 is made of 304 stainless steel. At least two first cavities 4113 are provided inside the body tube 4111, and the first support member 4112 is disposed within the first cavity 4113. In this fourth embodiment, the outer tube 412 does not have the first support member 4112 and the first cavity 4113, and the inner tube 411 does not have an intermediate layer and an inner layer, thereby avoiding excessive support of the adjustable bending sheath 41, which would make the adjustable bending sheath 41 difficult to bend. The main tube 4111 is made of nylon 12 material, and the inner tube 411 is made of a thicker single-layer nylon tube. Nylon tubes have good support properties, so only a single layer of nylon tube is needed to meet the support requirements, thereby simplifying the manufacturing process of the inner tube 411, saving costs, and improving product yield. At the same time, the better support properties of the main tube 4111 facilitate the manufacturing and forming of the first cavity 4113. Placing the first support member 4112 inside the inner tube 411 ensures that the first support member 4112 plays a role in controlling the bending direction, while also facilitating the overall bending of the bending sheath 41.

[0059] Please see Figure 17 In other specific embodiments of the present invention, the positions of the first cavity 4113 and the first support member 4112 can be adapted according to actual usage. For example, the first cavity 4113 can be provided in both the inner tube 411 and the outer tube 412, and multiple first support members 4112 can be respectively provided in the first cavity 4113 of the inner tube 411 and the outer tube 412. Simultaneously, an inner liner and a braided layer can also be adapted according to actual usage. For example, the inner tube 411 may also include an inner liner 4114 and a braided layer 4115. The inner liner 4114 is made of polytetrafluoroethylene, and the braided layer 4115 is woven from nickel-titanium wire. The braided layer 4115 is sleeved on the inner liner 4114, and the main tube 4111 is sleeved on the braided layer 4115. The function of the braided layer 4115 is the same as that of the intermediate layer 232 in the first embodiment, and the function of the inner liner 4114 is the same as that of the inner layer 231 in the first embodiment, so it will not be described again here.

[0060] Compared with existing technologies, the adjustable bending delivery system of the present invention has the following advantages: The adjustable bending delivery system of the present invention separates the bending device for bending the delivery sheath from the delivery device itself, allowing them to enter the body separately. This eliminates the need to house the traction wire for bending within the delivery sheath, resulting in a larger internal space and making the delivery device suitable for a wider range of medical devices of different sizes and specifications, thus broadening its application scope. Simultaneously, the present invention requires less force for bending, allowing for easy bending of the delivery sheath. This results in higher bending sensitivity, a larger adjustable bending angle, and better control and precision of the bent angle. Furthermore, the lower force required for bending facilitates operation by the physician, avoiding errors caused by excessive force and preventing the adjustable bending delivery system from shaking, which could lead to medical accidents or affect surgical outcomes.

[0061] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An adjustable bend delivery system for delivering an implant into a human body, characterized by: The adjustable bending delivery system comprises a delivery device and a bending device, the delivery device comprises a delivery sheath, the bending device comprises a bending sheath and a matching piece, the matching piece comprises a hollow structure with a receiving cavity, the bending sheath comprises an inner tube and an outer tube, the outer tube is sleeved on the inner tube, the distal ends of the inner tube and the outer tube are fixedly connected with the proximal end of the matching piece, and a second opening is formed on the distal side of the outer tube; the distal end of the delivery sheath enters the human body from an artery on one leg, the distal end of the bending device enters the human body from an artery on the other leg, and after the distal ends of the delivery sheath and the bending device are pushed to the abdominal aorta, the distal end of the delivery sheath is received in the receiving cavity, so that the delivery sheath and the distal end of the bending device are matched in the abdominal aorta; when the inner tube is pushed to the distal end, the distal end of the inner tube is bent and exposed outside the outer tube through the second opening, and the distally bent inner tube can drive the matching piece to move, and the movement of the matching piece drives the delivery sheath to bend.

2. The adjustable bend conveyor system of claim 1, wherein: The matching piece comprises a main body part and a gathering part located on the distal side of the main body part, the main body part comprises a cylindrical structure, the gathering part comprises a conical structure, one end of the main body part is connected with the distal end of the bending sheath, the other end of the main body part is connected with the gathering part, the diameter of the gathering part gradually decreases from the proximal end to the distal end, and when the delivery sheath and the bending sheath are matched, the distal end of the delivery sheath is received in the gathering part.

3. The adjustable bend conveyor system of claim 2, wherein: The gathering part comprises a plurality of gathering lobes, one end of each of the plurality of gathering lobes is arranged on the distal end of the main body part in a spaced manner, and the other end of each of the plurality of gathering lobes is gathered and close to each other in a distal direction.

4. The adjustable bend conveyor system of claim 1, wherein: A first opening is formed on the side wall of the matching piece, and the first opening is in communication with the receiving cavity.

5. The adjustable bend conveyor system of claim 1, wherein: A hinge part is arranged at the proximal end of the matching piece, the distal end of the outer tube is rotatably connected with the hinge part, and the distal end of the inner tube is fixedly connected with the proximal end of the matching piece; when the inner tube is pushed to the distal end, the inner tube is bent to drive the matching piece to rotate around the hinge part.

6. The adjustable bend conveyor system of claim 1, wherein: The outer tube and / or the inner tube is provided with two first cavities and two first supporting pieces, and one first supporting piece is arranged in one first cavity.

7. The adjustable bend conveyor system of claim 6, wherein: The inner tube comprises a body tube, an inner lining tube and a braided layer, the braided layer is sleeved on the inner lining tube, the body tube is sleeved on the braided layer, and the first cavities are arranged in the body tube.

8. The adjustable bend conveyance system of any of claims 1-7, wherein: The delivery device further comprises a delivery handle, the bending device further comprises a bending handle, the bending handle comprises a handle body and a pushing piece, the pushing piece is slidably connected with the handle body, the proximal end of the delivery sheath is received in the delivery handle, the proximal end of the bending sheath is received in the bending handle, and the proximal end of the inner tube is connected with the pushing piece; the movement of the pushing piece can drive the inner tube to move relative to the outer tube.

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