Bending-adjustable conveying system

Abstract

The invention relates to a bending-adjustable conveying system which is used for conveying an implant into a human body, the bending-adjustable conveying system comprises a conveyor and a bending adjusting device, the conveyor comprises a conveying sheathing canal, the bending adjusting device comprises a bending adjusting sheathing canal, the far end of the bending adjusting sheathing canal can be bent so that the far end of the bending adjusting device can be bent, and the bending adjusting sheathing canal is connected with the conveying sheathing canal. The far end of the conveying sheathing canal can enter the human body from the artery on one leg, the far end of the bending adjusting device can enter the human body from the artery on the other leg, and after the conveying sheathing canal and the far end of the bending adjusting device are pushed to the aorta abdominalis, the conveying sheathing canal and the far end of the bending adjusting device can be matched in the aorta abdominalis, so that the conveying sheathing canal and the bending adjusting device can be matched in the aorta abdominalis. And further, the bending adjusting sheath tube can drive the conveying sheath tube to be bent after being bent. The bending adjusting force needed by the bending-adjustable conveying system is smaller, the bending adjusting sensitivity is higher, the bending adjusting process is more stable, the bending adjusting direction is more accurate, and the overall bending adjusting effect is better.

Description

Technical Field

[0001] The present invention relates to the field of interventional medicine, and in particular to an adjustable bend delivery system. Background Art

[0002] Valvular diseases in the elderly and valvular diseases caused by myocardial infarction due to coronary heart disease are becoming more and more common. These valvular diseases not only endanger life safety and affect the quality of life, but also bring heavy burdens and pressures to families and society. The human heart consists of four heart chambers: the left atrium, left ventricle, right atrium, and right ventricle. The two atria are connected to the two ventricles through the mitral valve and tricuspid valve, respectively, and the two ventricles are connected to the two aortas. The 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 of the human body are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. If these valves have lesions, the type of lesions is usually stenosis or incomplete closure, which will hinder normal blood flow and increase the corresponding heart burden, thereby causing damage to the normal function of the heart, leading to heart failure and changes in the functions of multiple organs in the body.

[0003] At present, the main surgical treatment for valvular heart disease is valve replacement, that is, replacing the diseased heart valve with an artificial mechanical valve device or a biological valve device. In transcatheter aortic valve replacement, the catheter needs to pass through the curved aortic arch and then reach the aortic valve lesion. Therefore, the catheter needs to be bent so that the catheter can smoothly reach the aortic valve lesion. However, the existing catheters are bent by pulling the catheter with a bending wire set on the catheter, which will increase the size of the catheter, reduce the space inside the catheter for loading medical devices, and reduce the application range of the catheter. At the same time, the pulling force required for bending by the bending wire is large, and the pulling force cannot be accurately controlled, which makes the bending sensitivity low and the bending effect unsatisfactory. Furthermore, the catheter bent by the bending wire has a small bending angle and low applicability. Summary of the invention

[0004] In order to overcome the problems existing in the prior art, the present invention provides an adjustable bend conveying system.

[0005] The solution to the technical problem of the present invention is to provide an adjustable bend delivery system for delivering an implant into the human body, the adjustable bend delivery system comprising a conveyor and a bend adjusting device, the conveyor comprising a conveying sheath, the bend adjusting device comprising a bend adjusting sheath, the distal end of the bend adjusting sheath can be bent thereby causing the distal end of the bend adjusting device to bend, the distal end of the conveying sheath can enter the human body from an artery on one leg, and the distal end of the bend adjusting device can enter the human body from an artery on the other leg, when the conveying sheath and the distal end of the bend adjusting device are pushed into the abdominal aorta, the conveying sheath and the distal end of the bend adjusting device can cooperate in the abdominal aorta, thereby causing the bend adjusting sheath to drive the conveying sheath to bend after being bent.

[0006] In some embodiments of the present invention, the bending adjustment device also includes a matching piece, which includes a hollow structure with a accommodating cavity. One end of the matching piece is connected to the distal end of the bending adjustment sheath. When the delivery sheath cooperates with the bending adjustment sheath, the distal end of the delivery sheath can be received in the accommodating cavity. After the bending adjustment sheath is bent, it drives the matching piece to move, and the movement of the matching piece drives the delivery sheath to bend.

[0007] In some embodiments of the present invention, the mating part includes a main body and a gathering part located on the distal side of the main body, the main body includes a cylindrical structure, the gathering part includes a conical structure, one end of the main body is connected to the distal end of the bending adjustment sheath, and the other end of the main body is connected to the gathering part, the diameter of the gathering part gradually decreases from the proximal end to the distal end, and when the delivery sheath is mated with the bending adjustment sheath, the distal end of the delivery sheath is received in the gathering part.

[0008] In some embodiments of the present invention, the gathering portion includes a plurality of gathering leaflets, one ends of the plurality of gathering leaflets are arranged at a distal end of the main body portion at intervals, and the other ends of the plurality of gathering leaflets gather close to each other toward the distal end.

[0009] In some embodiments of the present invention, a first opening is formed on a side wall of the matching piece, and the first opening is communicated with the accommodating cavity.

[0010] In some embodiments of the present invention, the bending adjustment sheath includes 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 connected to the proximal end of the matching piece, and a second opening is provided on the distal side of the outer tube. When the inner tube is pushed toward the distal end, the distal end of the inner tube is bent and exposed outside the outer tube through the second opening. The inner tube with its distal end bent can drive the matching piece to move.

[0011] In some embodiments of the present invention, a hinged portion is provided at the proximal end of the fitting, the distal end of the outer tube and the hinged portion are rotatably connected, the distal end of the inner tube and the proximal end of the fitting are fixedly connected, and when the inner tube is pushed toward the distal end, the inner tube bends and the fitting is rotated around the hinged portion.

[0012] In some embodiments of the present invention, the outer tube and / or the inner tube is provided with two first cavities and two first support members, and one first support member is arranged in one first cavity.

[0013] In some embodiments of the present invention, the inner tube includes a main body tube, a lining tube and a braided layer, the braided layer is sleeved on the lining tube, the main body tube is sleeved on the braided layer, and the first cavity is disposed in the main body tube.

[0014] In some embodiments of the present invention, it is characterized in that: the conveyor also includes a conveying handle, the bending adjustment device also includes a bending adjustment handle, the bending adjustment handle includes a handle body and a pushing member, the pushing member is slidably connected to the handle body, the proximal end of the conveying sheath is received in the conveying handle, the proximal end of the bending adjustment sheath is received in the bending adjustment handle, and the proximal end of the inner tube is connected to the pushing member, and the movement of the pushing member can drive the inner tube to move relative to the outer tube.

[0015] Compared with the prior art, the adjustable bend delivery system of the present invention has the following advantages: the adjustable bend delivery system of the present invention separates the bend adjustment device for adjusting the bend of the delivery sheath from the delivery device, and enters the human body separately, so that the delivery sheath no longer needs to accommodate the traction wire for adjusting the bend, so that the internal space of the delivery sheath is larger, and thus the delivery device can be applied to more medical devices of different sizes and specifications, and has a wider range of applications. At the same time, the force required for the bend adjustment of the present invention is smaller, and the delivery sheath can be easily bended, so that the bending sensitivity of the bending sheath is higher, the adjustable bend angle is larger, and the angle of the bending sheath after adjustment is better controlled and more precise. At the same time, the smaller force required for the bend adjustment is more conducive to the doctor's operation, avoiding misoperation due to too much force required for the bend adjustment, and avoiding shaking of the adjustable bend delivery system due to too much force required for the bend adjustment, thereby causing medical accidents, affecting the surgical effect, and other problems. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a schematic diagram of the three-dimensional structure of the adjustable bend conveying system provided in the first embodiment of the present invention.

[0017] Figure 2 It is a schematic diagram of the structure of the adjustable bend delivery system provided by the first embodiment of the present invention when it is fitted in the human body.

[0018] Figure 3 It is a schematic structural diagram of the adjustable bend delivery system provided by the first embodiment of the present invention delivering adjustable bends in the human body.

[0019] Figure 4 It is a schematic structural diagram of the adjustable bending conveying system provided by the first embodiment of the present invention when completing bending adjustment in the human body.

[0020] Figure 5 It is a three-dimensional structural schematic diagram of the adjustable bending sheath tube and matching parts of the adjustable bending conveying system provided in the first embodiment of the present invention.

[0021] Figure 6 It is a schematic diagram of the three-dimensional structure of the delivery sheath of the adjustable bend delivery system provided in the first embodiment of the present invention.

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

[0023] Figure 8 It is a schematic diagram of the cross-sectional structure of an inner tube or an outer tube of the adjustable bend conveying system provided in the first embodiment of the present invention.

[0024] Fig. 9 It is a schematic diagram of the separation structure of the inner tube or the outer tube of the adjustable bend conveying system provided in another embodiment of the present invention.

[0025] Fig.10 It is a schematic diagram of the three-dimensional structure of the adjustable bend conveying system provided in the second embodiment of the present invention.

[0026] Fig.11 It is a schematic diagram of the structure of the bending sheath and matching parts of the adjustable bending conveying system provided in the second embodiment of the present invention.

[0027] Fig.12 It is a schematic diagram of the retracted structure of the bending sheath and matching parts of the adjustable bending conveying system provided by the second embodiment of the present invention.

[0028] Fig.13 It is a schematic diagram of the three-dimensional structure of the adjustable bend conveying system provided in the third embodiment of the present invention.

[0029] Fig.14 It is a schematic diagram of the structure of the bending sheath and matching parts of the adjustable bending conveying system provided in the third embodiment of the present invention.

[0030] Fig.15 It is a schematic diagram of the three-dimensional structure of the adjustable bend conveying system provided in the fourth embodiment of the present invention.

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

[0032] Fig.17 It is a schematic diagram of the cross-sectional structure of the adjustable bending sheath tube of the adjustable bending delivery system provided in other embodiments of the present invention.

[0033] Description of the accompanying drawings: 100, adjustable bend conveying system; 1, conveyor; 2, bend adjusting device; 11, conveying sheath; 12, conveying handle; 21, bend adjusting sheath; 22, matching piece; 221, accommodating cavity; 111, outer sheath; 112, inner core tube; 113, tip; 114, loading section; 222, first opening; 211, inner tube; 212, outer tube; 2121, second opening; 231, inner layer; 232, middle layer; 233, outer layer; 2122, first cavity; 2123, first support; 23, bend adjusting handle; 200, adjustable bend conveying system; 22', matching piece; 223, main body; 224, gathering part; 21', bending adjustment sheath; 11', delivery sheath; 2241, gathering leaflets; 113', tip head; 300, adjustable delivery system; 32, matching piece; 321, hinged part; 34, outer tube; 33, inner tube; 3211, fixing part; 3212, rotating shaft; 400, adjustable delivery system; 411, inner tube; 4111, main body tube; 4112, first support member; 4113, first cavity; 412, outer tube; 41, bending adjustment sheath; 4114, lining tube; 4115, braided layer. DETAILED DESCRIPTION

[0034] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0035] It should be understood that the terms used herein are only for the purpose of describing specific example embodiments and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0036] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0037] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will 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 can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0038] In order to more clearly describe the structure of the present application, the terms "proximal end" and "distal end" are defined herein as commonly used terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, "proximal end" refers to the end close to the operator during the surgical operation, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.

[0039] See also Figure 1The first embodiment of the present invention provides an adjustable bend delivery system 100 for delivering a medical device to be implanted in a human body to a lesion site. The system is particularly suitable for transcatheter aortic valve replacement and can also be used for surgeries in the fields of mitral valve, tricuspid valve, pulmonary valve, heart bypass, etc. The present invention takes the use of the adjustable bend delivery system 100 for transcatheter aortic valve replacement as an example for detailed description. The adjustable bend delivery system 100 includes a conveyor 1 and a bend adjustment device 2. The conveyor 1 includes a conveying sheath 11, and the bend adjustment device 2 includes a bend adjustment sheath 21. The conveying sheath 11 can be loaded with an aortic valve device and deliver the aortic valve device to the lesion site. The bend adjustment device 2 is used to bend the conveying sheath 11. Specifically, the conveying sheath 11 can enter the human body from the artery on the left leg or the artery on the right leg, and correspondingly, the distal end of the bend adjustment device 2 can enter the human body from the artery on the right leg or the artery on the left leg. After the delivery sheath 11 and the distal end of the bending adjustment device 2 are pushed to the abdominal aorta, the delivery sheath 11 and the distal end of the bending adjustment device 2 can cooperate in the abdominal aorta. At the same time, the distal end of the bending adjustment sheath 21 can bend, thereby causing the distal end of the bending adjustment device 2 to bend. Therefore, when the delivery sheath 11 and the distal end of the bending adjustment device 2 cooperate in the common iliac artery, the bending of the bending adjustment sheath 21 can drive the delivery sheath 11 to bend, thereby completing the bending of the delivery sheath 11.

[0040] It can be understood that in the first embodiment of the present invention, the artery on the left leg and the artery on 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 human body from the femoral artery, the external iliac artery or the common iliac artery on the left leg, and at this time, the distal end of the bending adjustment device 2 enters the human body from the femoral artery, the external iliac artery or the common iliac artery on the right leg. After the distal ends of the delivery sheath 11 and the bending adjustment device 2 enter the human body, push the delivery sheath 11 and the bending adjustment device 2 to move toward the abdominal aorta until the distal ends of the delivery sheath 11 and the bending adjustment device 2 reach the abdominal aorta. Since the abdominal aorta has a large space, the delivery sheath 11 and the bending adjustment device 2 can cooperate in the abdominal aorta, such as Figure 2As shown. After the delivery sheath 11 and the bending adjustment device 2 cooperate, the delivery sheath 11 and the bending adjustment device 2 are pushed at the same time, so that the two move forward in the direction of the aortic arch. When the delivery sheath 11 and the bending adjustment device 2 are close to the aortic arch, the distal end of the bending adjustment sheath 21 can be bent, and the distal end of the delivery sheath 11 can be bent, thereby adjusting the angles of the distal ends of the delivery sheath 11 and the bending adjustment device 2, so that the distal ends of the delivery sheath 11 and the bending adjustment device 2 can smoothly enter the aortic arch, and then by continuously adjusting the angles of the distal ends of the delivery sheath 11 and the bending adjustment device 2, the two can smoothly pass through the aortic arch and reach the location of aortic valve lesions, as shown. Figure 3 shown.

[0041] The present invention separates the bending device 2 for bending the delivery sheath 11 from the delivery device 1 and enters the human body separately, so that the delivery sheath 11 does not need to contain the traction wire for bending, and the internal space of the delivery sheath 11 is larger. In addition, the delivery device 1 can be applied to more medical devices of different sizes and specifications, and has a wider range of applications.

[0042] Please combine Figure 1 and Figure 5 The bending adjustment device 2 also includes a matching piece 22. In the first embodiment of the present invention, the matching piece 22 is a cylindrical structure, and the matching piece 22 includes a hollow structure with a housing cavity 221. The shape of the housing cavity 221 corresponds to the shape of the delivery sheath 11, and the size of the housing cavity 221 is larger than the size of the delivery sheath 11. One end of the matching piece 22 is connected to the distal end of the bending adjustment sheath 21, and the other end of the matching piece 22 is a free end. When the delivery sheath 11 cooperates with the bending adjustment device 2, the distal end of the delivery sheath 11 can be accommodated in the housing cavity 221, that is, the matching piece 22 cooperates with the distal end of the delivery sheath 11. After the bending adjustment sheath 21 is bent, it drives the matching piece 22 to deflect and then move. The deflection of the matching piece 22 will drive the delivery sheath 11 to bend.

[0043] The accommodating cavity 221 extends from the distal end to the proximal end of the fitting 22. When the fitting 22 is matched with the delivery sheath 11, the proximal end of the fitting 22 is directed toward the distal end of the delivery sheath 11. Figure 1 As shown. Then, the bending sheath 21 can be withdrawn or the delivery sheath 11 can be pushed, so that the delivery sheath 11 enters the accommodating cavity 221, thereby completing the matching between the delivery sheath 11 and the matching piece 22. After the delivery sheath 11 and the matching piece 22 are matched, the matching piece 22 can move along the length direction of the delivery sheath 11.

[0044] For further information, see Figure 5 and Figure 6 In the first embodiment of the present invention, the delivery sheath tube 11 comprises an outer sheath tube 111, an inner core tube 112 and a tip head 113, and the distal end of the inner core tube 112 is connected to the tip head 113. The outer sheath tube 111 is sleeved on the inner core tube 112 and is coaxially arranged with the inner core tube 112, and the outer sheath tube 111 can move axially relative to the inner core tube 112. The proximal end surface 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 tube 111 jointly define a loading section 114, that is, the loading section 114 is arranged at the distal end of the delivery sheath tube 11, and the aortic valve device is loaded on the loading section 114, and the matching piece 22 matches with the outer sheath tube 111 at the position of the loading section 114. When the delivery sheath 11 reaches the aortic valve lesion, the outer sheath 111 is withdrawn so that the loading section 114 is exposed outside the outer sheath 111, thereby allowing the aortic valve device loaded on the loading section 114 to expand and release. At the same time, in order to prevent the bending device 2 from hindering the release of the aortic valve device, the bending sheath 21 can be withdrawn before releasing the aortic valve device, so that the matching piece 22 is away from the loading section 114, thereby preventing the matching piece 22 from hindering the release of the aortic valve device. At the same time, in order to ensure the bending effect of the bending device 2 and avoid the matching piece 22 being withdrawn when the aortic valve device is not released, resulting in the distal end of the delivery sheath 11 not being bent, thereby preventing the aortic valve device from being accurately released at the lesion position, the withdrawal of the outer sheath 111 and the withdrawal of the matching piece 22 should be coordinated. Specifically, when releasing the aortic valve device, the outer sheath 111 can be withdrawn a short distance first, so that the distal end of the aortic valve device is released, and the distal end of the aortic valve device is anchored at the lesion position, thereby ensuring the accurate release of the aortic valve device. After the distal end of the aortic valve device is released, the matching piece 22 can be withdrawn a short distance, and then the outer sheath 111 can be withdrawn a short distance, so that the middle section of the aortic valve device can be released, and then the matching piece 22 can be withdrawn again, and then the outer sheath 111 can be withdrawn again, until the aortic valve device is completely released, the delivery sheath 11 and the bending sheath 21 can be withdrawn to the abdominal aorta. Then, the delivery sheath 11 and the matching piece 22 are untied at the abdominal aorta, and the delivery device 1 and the bending device 2 can be withdrawn from the human body respectively.

[0045] Furthermore, before the bending adjustment device 2 enters the human body, the bending adjustment sheath 21 and the matching piece 22 of the bending adjustment device 2 need to be compressed and loaded into the catheter sheath (not shown), and the bending adjustment sheath 21 and the matching piece 22 enter the human body together with the catheter sheath in the catheter sheath, and the catheter sheath transports the bending adjustment sheath 21 and the matching piece 22 to the abdominal aorta, and then the distal end of the bending adjustment sheath 21 and the matching piece 22 can be released from the catheter sheath. Please continue reading Figure 5 In the first embodiment of the present invention, in order to facilitate the compression of the fitting 22 into the catheter sheath, a first opening 222 is provided on the side wall of the fitting 22, the first opening 222 is connected to the accommodating cavity 221, the first opening 222 runs from the proximal end of the fitting 22 to the distal end of the fitting 22, and the first opening 222 is parallel to the axial direction of the fitting 22. Through the first opening 222, when the fitting 22 is compressed, the first opening 222 of the fitting 22 can be compressed into the accommodating cavity 221, thereby compressing the fitting 22 into a smaller volume, so that the fitting 22 can be smoothly loaded into the catheter sheath. At the same time, in order to ensure the support and flexibility of the fitting 22, the fitting 22 has a certain support to adjust the delivery sheath 11, and has a certain flexibility to facilitate the compression of the fitting 22, the fitting 22 includes a three-layer structure, that is, the fitting 22 is a three-layer structure with an inner layer, a middle layer, and an outer layer. The inner layer is made of polytetrafluoroethylene material, 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 fitting 22.

[0046] In other specific embodiments of the present invention, the first opening 222 is also arranged at an angle to the axial direction of the fitting 22 to facilitate spiral compression of the fitting 22. The first opening 222 can also be a plurality of through slots arranged on the side wall of the fitting 22, and the plurality of through slots are arranged at intervals along the circumferential direction of the fitting 22. At the same time, the plurality of through slots can be arranged parallel to the axial direction of the fitting 22, or can be arranged at an angle to the axial direction of the fitting 22.

[0047] See also Figure 1 and Figure 7The bending adjustment 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 the inner tube 211 and the outer tube 212 are connected to the proximal end of the fitting 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 toward the distal end, the distal end of the inner tube 211 is bent and exposed outside the outer tube 212 through the second opening 2121. The bent inner tube 211 at the distal end can drive the fitting 22 to move. The movement of the fitting 22 further drives the delivery sheath 11 to bend. Specifically, the distal ends of the inner tube 211 and the outer tube 212 are fixedly connected to the proximal end of the fitting 22. When the delivery sheath 11 needs to be bent, the outer tube 212 is first stabilized to prevent the outer tube 212 from axial movement. Then, the inner tube 211 is pushed, and the pushed inner tube 211 will move toward the direction of the fitting 22 and bend. The bent portion of the inner tube 211 will be exposed to the outside of the outer tube 212 through the second opening 2121, and because the outer tube 212 is in a stable state, the outer tube 212 will not be driven by the inner tube 211 to move. Therefore, when the inner tube 211 is pushed, the bending sheath 21 will not move in the axial direction to prevent the fitting 22 from slipping off the delivery sheath 11. At the same time, after the inner tube 211 is bent, it will drive the fitting 22 to move, and the movement of the fitting 22 will drive the delivery sheath 11 to bend, thereby completing the bending of the delivery sheath 11.

[0048] It can be understood that by pushing the inner tube 211 to bend the delivery sheath 11, the required pushing force is small, that is, the force required for bending is smaller, and the delivery sheath 11 can be easily bent, so that the bending sensitivity of the inner tube 211 is higher, the adjustable bending angle is larger, and the angle of the inner tube 211 after bending is better controlled and more precise. At the same time, the smaller force required for bending is more conducive to the doctor's operation, avoiding misoperation due to too much force required for bending, and also avoiding shaking of the adjustable bending delivery system 100 due to too much force required for bending, thereby causing medical accidents and affecting the effect of surgery.

[0049] See also Figure 7 - Fig. 9In the first embodiment of the present invention, the inner tube 211 and the outer tube 212 both include an inner layer 231, an intermediate layer 232 and an outer layer 233. The inner layer 231 is made of polytetrafluoroethylene material, the intermediate layer 232 is woven from nickel-titanium wire, the outer layer 233 is made of PEBAX material, and a hydrophilic coating is provided on the outer surface of the outer tube 212. Specifically, the inner layer 231 is an inner liner made of polytetrafluoroethylene material, the inner layer 231 has good support, and the inner layer 231 provides basic support for the inner tube 211 and the outer tube 212 as a whole. The intermediate layer 232 is a braided mesh tube woven from nickel-titanium wire, the intermediate layer 232 is sleeved on the inner layer 231, and the intermediate layer 232 is fixed to the inner layer 231 by hot melting. The intermediate layer 232 can further enhance the support of the inner tube 211 and the outer tube 212, so that the thrust required for the bending of the inner tube 211 is smaller, and the intermediate layer 232 can prevent the inner tube 211 and the outer tube 212 from becoming longer after being pulled by external force. The outer layer 233 is a tubular structure made of PEBAX material, and the outer layer 233 is sleeved on the intermediate layer 232, and the outer layer 233 is fixed to the intermediate layer 232 and / or the inner layer 231 by hot melting. The outer layer 233 can enhance the overall toughness and strength of the inner tube 211 or the outer tube 212, and the outer layer 233 made of PEBAX material has good biocompatibility. A hydrophilic coating is also provided on the outer surface of the outer layer 233, thereby ensuring the smoothness of the inner tube 211 and the outer tube 212 in the human body, and the outer layer 233 made of PEBAX material is more conducive to coating with a hydrophilic coating.

[0050] In other specific embodiments of the present invention, since during the operation, the inner tube 211 only needs to move in two ways, namely, pushing and rebounding, and the inner tube 211 will not be pulled, the middle 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 Figure 7 and Figure 8In the first embodiment of the present invention, two first cavities 2122 are arranged in 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 material and are long strip-shaped structures. The two first support members 2123 are respectively received in the two first cavities 2122. The first support members 2123 can limit the bending direction of the outer tube 212, and the first support members 2123 have a certain support property, so the outer tube 212 will not be able to bend in the direction where the first support members 2123 are arranged, and the outer tube 212 can only be bent in the direction where the first support members 2123 are not arranged. In the first embodiment of the present invention, the first cavity 2122 is symmetrically arranged, and the first support member 2123 is arranged in the symmetrical first cavity 2122, so that the bending sheath 21 can only be bent in two opposite directions without the first support member 2123, thereby ensuring the direction of the bending of the bending sheath 21, and avoiding the problem that the bending direction of the bending sheath 21 cannot be confirmed when the bending sheath 21 needs to be bent. At the same time, the middle layer 232 can protect the inner layer 231. When the bending sheath 21 is bent, the first support member 2123 will also bend. The middle layer 232 can avoid the situation where the rebound force caused by the bending deformation of the first support member 2123 is directly applied to the inner layer 231, causing the inner layer 231 to be damaged. Furthermore, the outer tube 212 is not affected by external force from the user when adjusting the bending, and the outer tube 212 is less affected by external force. In addition, the diameter of the outer tube 212 is relatively large, that is, the first support member 2123 is far away from the central axis of the outer tube 212, that is, the moment of inertia is relatively large. Therefore, arranging 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 in the inner layer 231 of the outer tube 212. When the bending direction accuracy is not required to be high, the first cavity 2122 and the first support member 2123 may be directly omitted to ensure the flexibility of the sheath tube.

[0053] Please combine Figure 1 and Figure 7The conveyor 1 also includes a conveying handle 12, and the proximal end of the conveying sheath 11 is received in the conveying handle 12. The conveying handle 12 is used to control the release of the aortic valve device loaded in the conveying sheath 11. The conveying handle 12 is a prior art and will not be described in detail here. The bending adjustment device 2 also includes a bending adjustment handle 23, and the bending adjustment handle 23 includes a handle body (not shown) and a pusher (not shown). The pusher is slidably connected to the handle body, and the pusher is partially received in the handle body and partially exposed outside the handle body. The proximal end of the bending adjustment sheath 21 is received in the bending adjustment handle, and the proximal end of the inner tube 211 is connected to the pusher. The movement of the pusher can drive the inner tube 211 to move relative to the outer tube 212. Specifically, the proximal end of the outer tube 212 can be fixed in the handle body to ensure that the outer tube 212 will not move relative to the axial direction of the handle body. When a bending operation is required, the pushing member is pushed toward the distal end, and the movement of the pushing member drives the inner tube 211 to move toward the distal end. Since the distal end of the inner tube 211 is fixed on the proximal end of the fitting 22, the inner tube 211 will bend, thereby achieving the bending of the delivery sheath 11.

[0054] See also Fig.10 and Fig.11 The second embodiment of the present invention provides an adjustable bend delivery system 200. The main difference between the adjustable bend delivery system 200 and the adjustable bend delivery system 100 of the first embodiment is that the matching piece 22' also includes a main body 223 and a gathering part 224 located at the distal end of the main body 223. The main body 223 includes a cylindrical structure, and the gathering part 224 includes a conical structure. One end of the main body 223 is connected to the distal end of the bending adjustment sheath 21', and the other end of the main body 223 is connected to the gathering part 224. The diameter of the gathering part 224 gradually decreases from the proximal end to the distal end. When the delivery sheath 11' is matched with the bending adjustment sheath 21', the distal end of the delivery sheath 11' is received in the gathering part 224. The gathering part 224 includes a plurality of gathering leaflets 2241.

[0055] Specifically, the gathering portion 224 is composed of a plurality of gathering leaflets 2241, and the gathering leaflets 2241 are triangular structures. The larger ends of the plurality of gathering leaflets 2241 are spaced apart from each other at the distal end of the main body 223, and the smaller ends of the plurality of gathering leaflets 2241 are gathered together toward the distal end, thereby forming the gathering portion 224 whose diameter gradually decreases from the proximal end to the distal end. At the same time, the gathering portion 224 includes a three-layer structure, that is, the gathering portion 224 is a three-layer structure having an inner layer, a middle layer, and an outer layer. The inner layer is made of polytetrafluoroethylene material, 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 gathering portion 224, so that the gathering portion 224 can have both support, flexibility and smoothness. It can be understood that in order to prevent the insufficient friction between the fitting 22' and the delivery sheath 11' during the bending adjustment, which causes the delivery sheath 11' to slide relative to the fitting 22', and then causes the delivery sheath 11' to be unable to bend. The fitting 22' of the second embodiment of the present invention includes a gathering portion 224, and the distal end of the delivery sheath 11' is received in the gathering portion 224, that is, the gathering portion 224 has a limiting effect on the delivery sheath 11', preventing the delivery sheath 11' from sliding toward the distal end. At the same time, the diameter of the gathering portion 224 gradually decreases from the proximal end to the distal end, so that the shape of the gathering portion 224 is similar to the shape of the tip head 113' of the delivery sheath 11', so that when the tip head 113' is received in the gathering portion 224, the tip head 113' and the gathering portion 224 fit more closely, so as to further ensure the limiting effect of the gathering portion 224 on the delivery sheath 11'. Furthermore, when the aortic valve device is released, the bending sheath 21' needs to be withdrawn, because the gathering portion 224 is composed of a plurality of gathering leaflets 2241, it is not a closed shape, and the gathering leaflets 2241 have a certain flexibility. Therefore, when the bending adjustment sheath tube 21' is withdrawn, the gathering leaflets 2241 are deformed, and the distal ends of the gathering leaflets 2241 are separated from each other, so that the delivery sheath tube 11' can pass through the gathering portion 224, and then the bending adjustment sheath tube 21' can be withdrawn relative to the delivery sheath tube 11'. Fig.12 shown.

[0056] See also Fig.13 and Fig.14The third embodiment of the present invention provides an adjustable bend conveying system 300, and the main difference between the adjustable bend conveying system 300 and the adjustable bend conveying system 100 of the first embodiment and the adjustable bend conveying system 200 of the second embodiment is that: the proximal end of the matching piece 32 is provided with a hinge portion 321, the distal end of the outer tube 34 is rotatably connected to the hinge portion 321, the distal end of the inner tube 33 is fixedly connected to the proximal end of the matching piece 32, and when the inner tube 33 is pushed toward the distal end, the inner tube 33 is bent so that the matching piece 32 is rotated around the hinge portion 321. Specifically, the hinge portion 321 includes a fixed portion 3211 fixedly connected to the matching piece 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, the inner tube 33 bends and drives the matching piece 32 to rotate around the rotation axis 3212. The arrangement of the hinge 321 makes the inner tube 33 bend and drives the matching piece 32 to rotate more smoothly. At the same time, the arrangement of the hinge 321 can determine the rotation axis and rotation radius of the matching piece 32, so that the bending of the adjustable bending conveying system 300 is more accurate and more precise.

[0057] It can be understood that a damping structure (not shown) can be set between the rotating shaft 3212 and the fixed part 3211, so that the matching part 32 needs to overcome a certain resistance when rotating through the rotating shaft 3212, so that the matching part 32 can maintain a certain angle after bending, thereby preventing the matching part 32 from being affected by the rebound force of the sheath and affecting the bending effect.

[0058] See also Fig.15 and Fig.16The fourth embodiment of the present invention provides an adjustable bend conveying system 400. The main difference between the adjustable bend conveying system 400 and the adjustable bend conveying system 100 of the first embodiment, the adjustable bend conveying system 200 of the second embodiment, and the adjustable bend conveying system 300 of the third embodiment is that the inner tube 411 includes a main body tube 4111 and a first support member 4112. The main body tube 4111 is made of nylon material, and the first support member 4112 is made of 304 stainless steel material. At least two first cavities 4113 are arranged in the main body tube 4111, and the first support member 4112 is arranged in the first cavity 4113. In the fourth embodiment of the present invention, 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 that the support of the adjustable bend sheath tube 41 is too strong, resulting in the difficulty of the adjustable bend sheath tube 41 to bend. The main body tube 4111 is made of nylon 12 material, and the inner tube 411 adopts a single-layer nylon tube with a relatively thick thickness. The nylon tube has good support, so only a single-layer nylon tube is needed to meet the support requirements, thereby achieving the purpose of simplifying the manufacturing process of the inner tube 411, saving costs, and improving product yield. At the same time, the main body tube 4111 with good support is more conducive to the production and molding of the first cavity 4113. The first support member 4112 is arranged in the inner tube 411, which is more conducive to the bending of the entire bending sheath tube 41 while ensuring that the first support member 4112 plays a role in controlling the bending direction.

[0059] See also Fig.17 In other specific embodiments of the present invention, the positions of the first cavity 4113 and the first support member 4112 can be adaptively set according to actual use conditions, such as the first cavity 4113 is set in both the inner tube 411 and the outer tube 412, and multiple first support members 4112 are respectively set in the first cavities 4113 of the inner tube 411 and the outer tube 412. At the same time, the inner liner and the braided layer can also be adaptively set according to actual use conditions, such as the inner tube 411 also includes an inner liner 4114 and a braided layer 4115, the inner liner 4114 is made of polytetrafluoroethylene material, and the braided layer 4115 is braided by nickel-titanium wire. The braided layer 4115 is sleeved on the inner liner 4114, and the main body 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 of the first embodiment, and the function of the inner liner 4114 is the same as that of the inner layer 231 of the first embodiment, so it is not repeated here.

[0060] Compared with the prior art, the adjustable bend delivery system of the present invention has the following advantages: the adjustable bend delivery system of the present invention separates the bend adjustment device for adjusting the bend of the delivery sheath from the delivery device, and enters the human body separately, so that the delivery sheath no longer needs to accommodate the traction wire for adjusting the bend, so that the internal space of the delivery sheath is larger, and thus the delivery device can be applied to more medical devices of different sizes and specifications, and has a wider range of applications. At the same time, the force required for the bend adjustment of the present invention is smaller, and the delivery sheath can be easily bended, so that the bending sensitivity of the bending sheath is higher, the adjustable bend angle is larger, and the angle of the bending sheath after adjustment is better controlled and more precise. At the same time, the smaller force required for the bend adjustment is more conducive to the doctor's operation, avoiding misoperation due to too much force required for the bend adjustment, and avoiding shaking of the adjustable bend delivery system due to too much force required for the bend adjustment, thereby causing medical accidents, affecting the surgical effect, and other problems.

[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 in the protection scope of the present invention.

Claims

1. An adjustable bend delivery system for delivering an implant into a human body, characterized in that: The adjustable bend delivery system includes a conveyor and a bend adjusting device, the conveyor includes a conveying sheath, the bend adjusting device includes a bend adjusting sheath, the distal end of the bend adjusting sheath can be bent, thereby causing the distal end of the bend adjusting device to bend, the distal end of the conveying sheath can enter the human body from an artery on one leg, and the distal end of the bend adjusting device can enter the human body from an artery on the other leg. When the conveying sheath and the distal end of the bend adjusting device are pushed to the abdominal aorta, the conveying sheath and the distal end of the bend adjusting device can cooperate in the abdominal aorta, thereby causing the bend adjusting sheath to drive the conveying sheath to bend after being bent.

2. The adjustable bend conveying system according to claim 1, characterized in that: The bending adjustment device also includes a matching piece, which includes a hollow structure with a accommodating cavity. One end of the matching piece is connected to the distal end of the bending adjustment sheath. When the delivery sheath is matched with the bending adjustment sheath, the distal end of the delivery sheath can be received in the accommodating cavity. After the bending adjustment sheath is bent, it drives the matching piece to move, and the movement of the matching piece drives the delivery sheath to bend.

3. The adjustable bend conveying system according to claim 2, characterized in that: The mating part includes a main body and a gathering part located on the distal side of the main body, the main body includes a cylindrical structure, the gathering part includes a conical structure, one end of the main body is connected to the distal end of the bending adjustment sheath, and the other end of the main body is connected to the gathering part, the diameter of the gathering part gradually decreases from the proximal end to the distal end, and when the delivery sheath is mated with the bending adjustment sheath, the distal end of the delivery sheath is received in the gathering part.

4. The adjustable bend conveying system according to claim 3, characterized in that: The gathering portion comprises a plurality of gathering leaflets, one ends of which are arranged at a distance from each other at the distal end of the main body portion, and the other ends of which are gathered and approached toward the distal end.

5. The adjustable bend conveying system according to claim 2, characterized in that: A first opening is formed on the side wall of the matching piece, and the first opening is communicated with the accommodating cavity.

6. The adjustable bend conveying system according to claim 2, characterized in that: The bending adjustment sheath includes 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 connected to the proximal end of the matching piece, and a second opening is provided on the side of the distal end of the outer tube. When the inner tube is pushed toward the distal end, the distal end of the inner tube is bent and exposed outside the outer tube through the second opening. The inner tube with its distal end bent can drive the matching piece to move.

7. The adjustable bend conveying system according to claim 6, characterized in that: A hinged portion is provided at the proximal end of the fitting, the distal end of the outer tube and the hinged portion are rotatably connected, the distal end of the inner tube and the proximal end of the fitting are fixedly connected, and when the inner tube is pushed toward the distal end, the inner tube bends and the fitting rotates around the hinged portion.

8. The adjustable bend conveying system according to claim 6, characterized in that: The outer tube and / or the inner tube is provided with two first cavities and two first support members, and one first support member is arranged in one first cavity.

9. The adjustable bend conveying system according to claim 8, characterized in that: The inner tube comprises a main body tube, an inner lining tube and a braided layer, the braided layer is sleeved on the inner lining tube, the main body tube is sleeved on the braided layer, and the first cavity is arranged in the main body tube.

10. The adjustable bend conveying system according to any one of claims 6 to 9, characterized in that: The conveyor also includes a conveying handle, and the bending adjustment device also includes a bending adjustment handle. The bending adjustment handle includes a handle body and a pushing member, and the pushing member is slidably connected to the handle body. The proximal end of the conveying sheath is housed in the conveying handle, and the proximal end of the bending adjustment sheath is housed in the bending adjustment handle, and the proximal end of the inner tube is connected to the pushing member. The movement of the pushing member can drive the inner tube to move relative to the outer tube.

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