Conveying assembly and conveying system

Abstract

The invention provides a conveying assembly and a conveying system. The conveying assembly comprises a bending adjusting wire and a conveying pipe. The conveying pipe comprises a sheath pipe section and an outer pipe section, the sheath pipe section is located at the far end of the outer pipe section, the sheath pipe section wraps at least one part of the outer pipe section, and the sheath pipe section is used for wrapping the valve prosthesis; the bending adjusting wire is parallel to the axial direction of the conveying pipe and penetrates through the inner wall of the conveying pipe, and the bending adjusting wire is folded back at the far end of the sheath pipe section and used for driving the conveying pipe to be bent in the process of conveying the valve prosthesis. According to the configuration, the bending adjusting wire is arranged on the inner wall of the conveying pipe in a penetrating mode and is bent back at the far end of the sheathing canal section, so that the action point of the bending adjusting wire is located at the far end of the sheathing canal section, meanwhile, the sheathing canal section wraps the valve prosthesis, the axial distance between the action point of the bending adjusting wire and the valve prosthesis is shortened, and the coaxial effect of the valve prosthesis and the native valve ring is effectively guaranteed.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a delivery component and a delivery system. Background Art

[0002] Transcatheter aortic valve replacement is a minimally invasive valve replacement surgery, which delivers an artificial valve prosthesis to the aortic root through a catheter and implants it to replace the original aortic valve and complete the replacement. At present, the artificial heart valve delivery system mainly consists of three parts: a handle, a catheter, and an artificial valve prosthesis. The artificial valve prosthesis is accommodated inside the catheter, and the outer part of the distal end of the catheter is a small sheath covering the valve and a large sheath covering the positioning piece; the distal end of the catheter reaches the heart disease valve through the femoral artery of the human body, and the large sheath is pulled proximally by manipulating the handle of the delivery system, and the positioning piece is released. The coaxiality of the valve prosthesis and the native valve ring is adjusted by bending the distal end of the catheter, and the distal end of the catheter is rotated around its own axis to align the valve prosthesis positioning piece with the native valve (circumferential positioning), and the delivery system is pushed to make the valve prosthesis positioning piece enter the sinus bottom, and then the small sheath matching the valve prosthesis is pulled toward the ventricle by manipulating the handle of the delivery system and the valve prosthesis is released.

[0003] In order to meet the demand for circumferential positioning function, the delivery components currently on the market mostly use outer tube bending, and the bending point is far away from the artificial valve prosthesis. In the prior art, the artificial valve prosthesis is enclosed in a small sheath at the distal end of the catheter portion, and the outer tube is arranged at the proximal end of the small sheath. Therefore, when the operator drives the outer tube to bend through the handle, the bending point is located at the outer tube, which is far away from the artificial valve prosthesis. It is often necessary to drive the outer tube to bend at a larger angle so that the bending angle at the artificial valve prosthesis reaches the preset effect, and therefore the coaxial effect cannot be effectively achieved. Summary of the invention

[0004] The object of the present invention is to provide a delivery component and a delivery system to solve the problem that the bending point of the existing delivery component is far away from the valve prosthesis and the coaxial effect cannot be effectively achieved.

[0005] In order to achieve the above object, the present invention provides a conveying assembly, comprising: a bending wire and a conveying tube;

[0006] The delivery tube comprises a sheath tube section and an outer tube section, wherein the sheath tube section is located at the distal end of the outer tube section, the sheath tube section covers at least a portion of the outer tube section, and the sheath tube section is used to cover the valve prosthesis;

[0007] The bending adjustment wire is arranged parallel to the axial direction of the delivery tube and penetrates the inner wall of the delivery tube. The bending adjustment wire is folded back at the distal end of the sheath tube segment and is used to drive the delivery tube to bend during the process of delivering the valve prosthesis.

[0008] Optionally, a plurality of return holes are provided at the distal end of the sheath section, and the plurality of return holes are arranged at intervals along the circumference of the delivery tube, and the bending adjustment wire passes through the inner wall of the delivery tube from one of the return holes and passes through the inner wall of the delivery tube from another return hole.

[0009] Optionally, a wire avoidance hole is provided at the proximal end of the sheath tube segment, and the wire avoidance hole is used for allowing the bending adjustment wire to pass through the inner wall of the sheath tube segment.

[0010] Optionally, the delivery assembly further comprises a back-through ring coaxially arranged with the delivery tube, the back-through ring being arranged at the distal end of the sheath tube segment and connected to the delivery tube, the back-through hole being arranged on the connecting end surface of the back-through ring and the delivery tube.

[0011] Optionally, a groove is further provided on the connecting end surface of the return-through ring and the delivery tube, and the return-through holes are provided at both ends of the groove along the circumference of the return-through ring. The bending adjustment wire passes through the inner wall of the delivery tube from one of the return-through holes and passes through the inner wall of the delivery tube from the other return-through hole. The groove is used to accommodate the bending adjustment wire located on the outside of the delivery tube.

[0012] Optionally, a wire avoidance hole is provided at the proximal end of the sheath tube segment, the wire avoidance hole and the groove are arranged at intervals along an axis parallel to the axial direction of the delivery tube, and the wire avoidance hole is used for allowing the bending wire to pass through the inner wall of the sheath tube segment.

[0013] Optionally, the sheath tube segment has a first inner layer, a first middle layer and a first outer layer arranged in sequence from inside to outside, and the bending adjustment wire is located between the first inner layer and the first middle layer.

[0014] Optionally, the sheath tube segment has a first inner layer, a first middle layer and a first outer layer arranged in sequence from inside to outside, and the bending adjustment wire is located between the first middle layer and the first outer layer.

[0015] Optionally, the delivery assembly further comprises a fixing wire, wherein the fixing wire is wound around the outside of the delivery tube.

[0016] Optionally, the first inner layer includes a PTFE layer, the first middle layer includes a cutting structure, and the first outer layer includes a polymer material layer.

[0017] Optionally, the sheath segment has a first inner layer, a first middle layer and a first outer layer arranged in sequence from the inside to the outside, the first middle layer is a cutting structure, and the cutting structure is composed of a plurality of groups of incisions arranged at intervals along the circumference of the delivery tube, and the distance between two adjacent incisions along the circumference of the delivery tube gradually increases from the distal end of the sheath segment to the proximal end of the sheath segment.

[0018] Optionally, the outer tube segment has a second inner layer, a second middle layer and a second outer layer arranged in sequence from the inside to the outside, and the bending adjustment wire is located between the second inner layer and the second middle layer.

[0019] Optionally, the second inner layer includes a PTFE layer, the second middle layer includes a woven structure, and the second outer layer includes a polymer material layer.

[0020] In order to achieve the above object, the present invention also provides a delivery system, comprising: a handle portion, a catheter portion and a valve prosthesis;

[0021] The catheter part includes a catheter assembly and the delivery assembly as described above, the delivery tube covers the catheter assembly, and the valve prosthesis is located between the delivery tube and the catheter assembly;

[0022] The handle portion is connected to the catheter portion, and is used to drive the delivery assembly and / or the catheter assembly to move along its own axial direction; or drive the catheter assembly to rotate around its own axis;

[0023] The handle is connected to the bending wire and is used to drive the delivery component to bend through the bending wire during the delivery of the valve prosthesis.

[0024] In summary, in the delivery assembly and delivery system provided by the present invention, the delivery assembly includes: a bending wire and a delivery tube; the delivery tube includes a sheath section and an outer tube section, the sheath section is located at the distal end of the outer tube section, the sheath section covers at least a portion of the outer tube section, and the sheath section is used to cover the valve prosthesis; the bending wire is arranged parallel to the axial direction of the delivery tube and penetrates the inner wall of the delivery tube, the bending wire is folded back at the distal end of the sheath section, and is used to drive the delivery tube to bend during the delivery of the valve prosthesis. Compared with the existing delivery assembly, the delivery assembly and delivery system provided by the present application have the following advantages:

[0025] (1) The bending wire is passed through the inner wall of the delivery tube and folded back at the distal end of the sheath section, so that the action point of the bending wire is located at the distal end of the sheath section. At the same time, the sheath section covers the valve prosthesis, shortening the axial distance between the action point of the bending wire and the valve prosthesis, effectively ensuring the coaxial effect of the valve prosthesis and the native valve ring;

[0026] (2) The handle portion is connected to the catheter portion and the bending adjustment wire respectively to drive the conveying component and / or the catheter component to move along its own axial direction, drive the catheter component to rotate around its own axis, and drive the conveying component to bend through the bending adjustment wire, so that the conveying system provided by the present application can simultaneously meet the two functional requirements of circumferential positioning and bending adjustment. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 A schematic diagram of the connection relationship between the first sheath tube segment and the bending adjustment wire provided in an embodiment of the present invention;

[0028] Figure 2 A schematic diagram of the connection relationship between the delivery pipe and the bending wire provided in an embodiment of the present invention;

[0029] Figure 3 A schematic diagram of the structure of a conveying system provided by an embodiment of the present invention;

[0030] Figure 4 A schematic diagram of the structure of a catheter portion provided by an embodiment of the present invention;

[0031] Figure 5 A schematic diagram of a catheter portion provided by an embodiment of the present invention during a surgical procedure;

[0032] Figure 6 A structural plan view of a sheath tube segment provided in an embodiment of the present invention;

[0033] Figure 7 A cross-sectional view showing the positional relationship between the first sheath tube segment and the bending adjustment wire provided in an embodiment of the present invention;

[0034] Figure 8 A cross-sectional view showing the positional relationship between the outer tube section and the bending adjustment wire provided in an embodiment of the present invention;

[0035] Fig. 9 A schematic diagram of the connection relationship between the second sheath tube segment and the bending adjustment wire provided in an embodiment of the present invention;

[0036] Fig.10 A schematic diagram of the connection relationship between the third sheath tube segment and the bending adjustment wire provided in an embodiment of the present invention;

[0037] Fig.11 A schematic diagram of the structure of a back-through loop provided in an embodiment of the present invention;

[0038] Fig.12 A schematic diagram of the connection relationship between a fourth sheath tube segment and a bending adjustment wire provided in an embodiment of the present invention.

[0039] The description of each reference numeral is as follows:

[0040] 10-Adjust the bending wire;

[0041] 11-transport tube; 111-sheath tube section; 112-outer tube section; 1111-first inner layer; 1112-first middle layer; 1113-first outer layer; 1114-incision; 1121-second inner layer; 1122-second middle layer; 1123-second outer layer;

[0042] 12-valve prosthesis; 13-retroperforation

[0043] 14-return ring; 141-groove; 142-connecting end face;

[0044] 15-wire avoidance hole; 16-fixing wire; 17-handle;

[0045] 18-catheter assembly; 181-inner core tube; 182-inner tube; 183-middle tube;

[0046] 19-valve prosthesis inflow channel; 20-valve prosthesis outflow channel; 21-prosthesis positioning piece; 22-small sheath tube; 23-axis line;

[0047] X-axial direction; Y-circumferential direction. DETAILED DESCRIPTION

[0048] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0049] As used in this specification, the singular forms "one", "an" and "the" include plural objects, the term "or" is generally used to include the meaning of "and / or", the term "several" is generally used to include the meaning of "at least one", and the term "at least two" is generally used to include the meaning of "two or more". In addition, the terms "first", "second" and "third" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of the features, "one end" and "the other end" and "proximal end" and "distal end" generally refer to two corresponding parts, which not only include the endpoints, wherein the "proximal end" generally represents the direction close to the doctor during the operation, and the "distal end" generally represents the direction close to the lesion during the operation. The terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral body; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. In addition, as used in this specification, an element disposed on another element generally only indicates that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the connection, coupling, cooperation or transmission between the two elements may be direct or indirect through an intermediate element, and it cannot be understood as indicating or implying the spatial position relationship between the two elements, that is, one element may be in any orientation such as inside, outside, above, below or on one side of another element, unless the content clearly indicates otherwise. The terms "upper", "lower", "top" and "bottom" are generally relative position relationships arranged in the direction of gravity; the terms "vertical, vertical direction" generally refer to the direction of gravity, which is generally perpendicular to the ground, and "horizontal, horizontal plane direction" generally refers to the direction parallel to the ground; for ordinary technicians in this field, the specific meanings of the above terms in this specification can be understood according to specific circumstances.

[0050] The object of the present invention is to provide a delivery component and a delivery system to solve the problem that the bending point of the existing delivery component is far away from the valve prosthesis and the coaxial effect cannot be effectively achieved.

[0051] The following description is given with reference to the accompanying drawings.

[0052] It can be understood by those skilled in the art that, taking valve replacement surgery as an example, after the valve prosthesis is delivered to the diseased valve through a catheter, the valve prosthesis and the native valve ring are usually not coaxial, and there are also differences in angle and position between the prosthesis positioning member and the native valve, which will affect the accuracy of the release position of the valve prosthesis, and thus affect the successful implementation of the replacement surgery. Therefore, the delivery system of the valve prosthesis needs to take into account the two functional requirements of bending and circumferential positioning. The existing delivery system maintains coaxiality between the valve prosthesis and the native valve ring by bending the outer tube, and realizes the alignment of the prosthesis positioning member and the native valve by rotating the catheter assembly around the axis; among them, since the valve prosthesis is usually placed in the sheath, the bending method of the outer tube will cause the bending point (i.e., the point of action of the bending structure) to be far away from the axial distance of the valve prosthesis, and the outer tube needs to be bent at a larger angle to make the valve prosthesis bend at an appropriate angle, and the coaxial effect cannot be effectively achieved. Based on this, the present embodiment provides a delivery assembly, which can effectively achieve a coaxial effect by setting the bending point at the distal end of the sheath segment so that the axial distance between the bending point and the valve prosthesis is shortened. It should be noted that the present application only takes valve replacement surgery as an example, and does not mean that the delivery assembly proposed in the present embodiment can only be used in valve replacement surgery scenarios. Its structure can also be applied to other components that require bending and rotation, such as stents, bone prostheses, etc. As long as the use scenario requires bending and rotation during the delivery process, the structure of the present application can be adopted.

[0053] Based on this, please refer to Figure 1 to Figure 2 The present invention provides a delivery assembly, including: a bending wire 10 and a delivery tube 11; the delivery tube 11 includes a sheath section 111 and an outer tube section 112, the sheath section 111 is located at the distal end of the outer tube section 112, the sheath section 111 covers at least a portion of the outer tube section 112, and the sheath section 111 is used to cover the valve prosthesis 12; the bending wire 10 is arranged parallel to the axial direction X of the delivery tube 11 and penetrates the inner wall of the delivery tube 11, the bending wire 10 is folded back at the distal end of the sheath section 111, and is used to drive the delivery tube 11 to bend during the delivery of the valve prosthesis 12. It should be noted that in Figure 1 Only the sheath section 111 is shown, and does not represent the overall structure of the delivery tube 11. In this embodiment, the overall structure of the delivery tube 11 is as shown in FIG. Figure 2As shown, it is a tubular member with a variable diameter structure, wherein the inner diameter of the sheath section 111 is greater than the outer diameter of the outer section 112, the proximal end of the sheath section 111 and the distal end of the outer section 112 are connected by hot-melt connection of a polymer material (including but not limited to Pebax, Pa, Pu and other materials), the sheath section 111 covers at least a portion of the outer section 112, and the bending wire 10 is sequentially passed through the inner walls of the sheath section 111 and the outer section 112. It can be understood by those skilled in the art that the bending wire 10 is folded back at the distal end of the sheath section 111, and the folding point of the bending wire 10 is the action point. The bending wire 10 applies a bending force at the action point (the direction of the bending force is set at an angle to the axial direction X of the delivery tube 11) so that the delivery tube 11 bends during the delivery process, and after reaching the diseased valve, the valve prosthesis 12 is ensured to be coaxial with the native valve ring by bending. In other embodiments, the connection between the sheath segment 111 and the outer tube segment 112 may also adopt a gradual structure for a smooth transition, and the connection between the sheath segment 111 and the outer tube segment 112 may also adopt a rounded structure for a smooth transition; the connection between the sheath segment 111 and the outer tube segment 112 may also be connected by other connection methods such as snap connection, threaded connection, etc.; the delivery tube 11 may also be an elliptical component, a rounded rectangular component or other components compatible with the structure of human blood vessels, and those skilled in the art may reasonably configure the structure and shape of the delivery tube 11 according to actual conditions.

[0054] With such configuration, in this embodiment, the bending wire 10 is folded back at the distal end of the sheath segment 111 to form an action point, and the valve prosthesis 12 is also located in the sheath segment 111, thereby shortening the axial distance between the action point of the bending wire 10 and the valve prosthesis 12, so that the bending angle of the delivery tube 11 driven by the bending wire 10 is close to the bending angle of the valve prosthesis 12 in the sheath segment 111, effectively ensuring the coaxiality of the valve prosthesis 12 and the native valve ring.

[0055] As an optional embodiment, the above-mentioned conveying assembly can be applied in Figures 3 to 5 Of course, in some other embodiments, the above-mentioned conveying assembly can also be used in other application scenarios, and the present invention is not limited to this. Figures 3 to 5The delivery system shown in is used as an example for explanation. The delivery system includes: a handle portion 17, a catheter portion and a valve prosthesis 12; the catheter portion includes a catheter assembly 18 and the above delivery assembly, the delivery tube 11 covers the catheter assembly 18, and the valve prosthesis 12 is located between the delivery tube 11 and the catheter assembly 18; the handle portion 17 is connected to the catheter portion, and is used to drive the delivery assembly and / or the catheter assembly 18 to move along its own axial direction X; or, drive the catheter assembly 18 to rotate around its own axis; the handle portion 17 is connected to the bending wire 10, and is used to drive the delivery assembly to bend through the bending wire 10 during the delivery of the valve prosthesis 12. Those skilled in the art will appreciate that in order to ensure the normal progress of the valve replacement surgery, the delivery system should also include: a valve prosthesis inlet duct 19, a valve prosthesis outflow duct 20, a prosthesis positioning member 21 and a small sheath 22, and the catheter assembly 18 includes: an inner core tube 181, an inner tube 182 and a middle tube 183; wherein the sheath segment 111 covers the valve prosthesis 12, the prosthesis positioning member 21, the small sheath 22 and the catheter assembly 18, the small sheath 22 covers the valve prosthesis inlet duct 19, and the middle tube 183 covers the valve prosthesis outflow duct 20. During the operation, the distal end of the catheter part is inserted into the femoral artery to the diseased valve, and the operator operates the handle part 17 to drive the sheath section 111 to move proximally along its own axis X to release the prosthesis positioning member 21; then the handle part 17 is operated to drive the delivery assembly to bend through the bending wire 10 to adjust the coaxiality of the valve prosthesis 12 and the native valve ring to achieve bending; at the same time, the handle part 17 is operated to drive the catheter assembly 18 to rotate along its own axis to align the prosthesis positioning member 21 with the native valve to achieve circumferential positioning; and then the handle part 17 is operated to push the entire delivery system or part of the delivery system ( For example, the sheath section 111 moves along its own axial direction X to drive the prosthesis positioning member 21 to enter the sinus bottom; and the handle section 17 is operated to drive the small sheath tube 22 to move along its own axial direction X toward the ventricle to release the valve prosthesis inflow tract 19; then the handle section 17 is operated to drive the middle tube 183 to move proximally along its own axial direction X to release the valve prosthesis outflow tract 20; finally, the handle section 17 is operated to drive the inner core tube 181 and the inner tube 182 to move along its own axial direction X to the ascending aorta, and drive the outer tube section 112 to move along its own axial direction X toward the ventricle to complete the system closure and withdraw from the body to complete the replacement operation. It should be noted that the handle section 17 can be a mechanical handle, and is connected to each component of the catheter section through a number of connecting wires to control the movement and / or rotation of each component.

[0056] So configured, this embodiment applies the above-mentioned delivery component to the delivery system, so that the delivery system takes into account both the functional requirements of bending adjustment and circumferential positioning, and by shortening the axial distance between the point of action of the bending adjustment wire 10 and the valve prosthesis 12, the coaxial effect between the valve prosthesis 12 and the native valve ring is effectively guaranteed.

[0057] Combine the following Figure 1 to Figure 2 as well as Figures 6 to 12 , specifically describe the connection relationship and positional relationship between the bending wire 10 and the conveying tube 11.

[0058] As an alternative embodiment, please refer to Figure 1 and Figure 6 The distal end of the sheath section 111 is provided with a back-through hole 13, and the bending adjustment wire 10 penetrates into or out of the inner wall of the delivery tube 11 at the back-through hole 13. It should be noted that the bending adjustment wire 10 penetrates into or out of the inner wall of the delivery tube 11 from the back-through hole 13. After the bending adjustment wire 10 is assembled, the bending adjustment wire 10 will be in a straightened state, and at this time it will contact the back-through hole 13. The position where the bending adjustment wire 10 contacts the back-through hole 13 is the action point of the bending adjustment wire 10; Figure 1 In the illustrated example, the return hole 13 is a waist-shaped hole having two straight sides and two arc-shaped sides, the straight sides and the arc-shaped sides are connected end to end in sequence, and the two straight sides are arranged in parallel, and the two arc-shaped sides are arranged symmetrically; in other embodiments, the return hole 13 may also be a circular hole, an elliptical hole, a square hole, a triangular hole or a hole of other irregular shapes, and those skilled in the art may configure the return hole 13 according to actual conditions.

[0059] As a preferred embodiment, the distal end of the sheath section 111 is provided with a plurality of back-through holes 13, which are arranged at intervals along the circumferential direction Y of the delivery tube 11, and the bending wire 10 passes through the inner wall of the delivery tube 11 from one of the back-through holes 13 and passes through the inner wall of the delivery tube 11 from another back-through hole 13. Figure 1 and Figure 6In the illustrated example, two return holes 13 are provided at the distal end of the sheath segment 111. The bending wire 10 passes through the inner wall of the delivery tube 11 from one of the return holes 13 and passes through the inner wall of the delivery tube 11 from the other return hole 13. Thus, the bending wire 10 is divided into two connecting segments and one return segment. The two connecting segments are located inside the delivery tube 11 and are respectively passed through the inner wall of the delivery tube 11 and are parallel to the axial direction X of the delivery tube 11. The return segment is located outside the delivery tube 11 and is respectively connected to the two connecting segments. At the same time, the return segment is located at the distal end of the delivery tube 11 and is closer to the axial distance of the valve prosthesis 12. Those skilled in the art can understand that the point of action of the bending adjustment wire 10 will not remain unchanged due to the influence of the bending degree and the bending adjustment force of the delivery tube 11, but will be distributed near the back-through hole 13. For example, in the process in which the sheath section 111 moves proximally along its own axial direction X and releases the small sheath 22 and the valve prosthesis outflow tract 20, the point of action of the bending adjustment wire 10 is at the back-through hole 13; when passing through the arch, affected by the bending degree of the delivery tube 11, the point of action of the bending adjustment wire 10 is located at the distal side of the sheath section 111. At this time, the bending adjustment force of passing through the arch is small, the delivery tube 11 is easy to bend, and the bending effect is more obvious; in the process of adjusting the coaxiality of the valve prosthesis 12 and the native valve ring, the point of action of the bending adjustment wire 10 is affected by the positional relationship of the components of the catheter assembly 18 and is located at the proximal side of the valve prosthesis outflow tract 20. At this time, the delivery tube 11 is easy to bend and the bending adjustment force is small; the operator can change the point of action of the bending adjustment wire 10 by driving the catheter part to move. In other embodiments, a plurality of bending adjustment holes may be provided, and a plurality of bending adjustment wires 10 may be provided, which respectively pass through the bending adjustment holes to enter or pass through the components that need to be bent. Those skilled in the art may configure the number of bending adjustment holes and bending adjustment wires 10 according to actual conditions.

[0060] For further information, please refer to Figure 2 , Figures 6 to 8 The sheath tube section 111 has a first inner layer 1111, a first intermediate layer 1112 and a first outer layer 1113 arranged in sequence from the inside to the outside, and the bending adjustment wire 10 is located between the first inner layer 1111 and the first intermediate layer 1112. The outer tube section 112 has a second inner layer 1121, a second intermediate layer 1122 and a second outer layer 1123 arranged in sequence from the inside to the outside, and the bending adjustment wire 10 is located between the second inner layer 1121 and the second intermediate layer 1122. It should be noted that the bending adjustment wire 10 is sequentially passed through the inner walls of the sheath tube section 111 and the outer tube section 112. The sheath tube section 111 includes a first inner layer 1111, a first intermediate layer 1112 and a first outer layer 1113. Figure 7 In the illustrated example, the first inner layer 1111 is a PTFE layer (polytetrafluoroethylene), the first middle layer 1112 is a hypotube, and the first outer layer 1113 is a polymer material layer (including but not limited to Pebax, Pa, Pu and other materials); the outer tube section 112 includes a second inner layer 1121, a second middle layer 1122 and a second outer layer 1123. Figure 8 In the illustrated example, the second inner layer 1121 is a PTFE layer (polytetrafluoroethylene), the second middle layer 1122 is a woven layer, and the second outer layer 1123 is a polymer material layer (including but not limited to Pebax, Pa, Pu and other materials). Figure 6 As shown, the first intermediate layer 1112 is a cutting structure, which is composed of a plurality of groups of cuts 1114 arranged at intervals along the circumferential direction Y of the delivery tube 11, and the distance between two adjacent cuts 1114 along the circumferential direction Y of the delivery tube 11 gradually increases from the distal end of the sheath segment 111 to the proximal end of the sheath segment 111. It can be understood by those skilled in the art that the portion between two adjacent cuts 1114 along the circumferential direction Y of the delivery tube 11 is a connecting rib. In this embodiment, the bending wire 10 needs to be passed through the inner wall of the sheath segment 111 and the outer tube segment 112, and the stiffness at the connection transition of the sheath segment 111 and the outer tube segment 112 increases linearly. With such a configuration, the width of the proximal side of the connecting rib along the circumferential direction Y of the delivery tube 11 (in Figure 6 The width of the connecting rib is greater than the width of the distal end of the connecting rib along the circumferential direction Y of the delivery tube 11, so as to prevent a sudden change in stiffness at the connection transition between the sheath section 111 and the outer tube section 112 from breaking the first intermediate layer 1112.

[0061] For further information, please refer to Figure 6 The proximal end of the sheath section 111 is provided with a wire avoidance hole 15, which is used to allow the bending wire 10 to pass through the inner wall of the delivery tube 11. Figure 6 In the illustrated example, the wire avoidance hole 15 has a convex section and a narrowing section, the convex section is connected to the narrowing section, and the convex section is located at the distal end of the narrowing section, wherein the width of the convex section along the circumferential direction Y of the conveying tube 11 (in Figure 6 The width of the narrowed section along the circumferential direction Y of the delivery tube 11 is greater than that of the narrowed section. One end of the narrowed section is connected to the outer convex section, and the other end is connected to the proximal end of the sheath section 111. The bending adjustment wire 10 can pass through the inner wall of the sheath section 111 at the outer convex section, and leave space to pass through the inner wall of the outer tube section 112, so that the bending adjustment wire 10 can have a smooth transition.

[0062] In another alternative embodiment, please refer to Fig. 9 The sheath section 111 has a first inner layer 1111, a first middle layer 1112 and a first outer layer 1113 which are arranged in sequence from the inside to the outside, and the bending adjustment wire 10 is located between the first middle layer 1112 and the first outer layer 1113. It should be noted that, at this time, since the bending adjustment wire 10 is located on the outside of the first middle layer 1112 (hypotube), in order to prevent the bending adjustment wire 10 from cutting the first outer layer 1113 (polymer material layer) and escaping therefrom during the bending process, it is necessary to add a fixing device to the outside of the delivery tube 11. Furthermore, the delivery assembly also includes a fixing wire 16, which is wound around the outside of the delivery tube 11. Fig. 9In the illustrated example, the fixing wire 16 is spirally wound around the outside of the delivery tube 11. In other embodiments, the fixing wire 16 can also be spirally wound around the outside of the delivery tube 11. The fixing wire 16 can be a coil, a braid, or other forms of components, and its cross section can be circular, square, or other irregular shapes. At the same time, for the material of the sheath section 111, the material of the outer tube section 112, the position of the bending wire 10 in the outer tube section 112, the configuration of the connecting ribs and the wire avoidance hole 15, please refer to Figure 6 and Figure 8 As well as the corresponding description above, this embodiment will not be repeated here.

[0063] In another embodiment, please refer to Figure 10 to Figure 11 The delivery assembly further includes a re-penetration ring 14, which is disposed at the distal end of the sheath section 111 and connected to the delivery tube 11. A re-penetration hole 13 is disposed on the connecting end surface 142 between the re-penetration ring 14 and the delivery tube 11. It should be noted that the connection between the re-penetration ring 14 and the delivery tube 11 can be welding, gluing, etc. Fig.11 In the illustrated example, the return-through ring 14 is an annular member, and the return-through hole 13 is a waist-shaped hole, which is arranged on the connecting end surface 142 between the return-through ring 14 and the delivery tube 11. With such a configuration, the bending wire 10 no longer needs to penetrate into or out of the inner wall of the delivery tube 11 during the process of the distal end of the delivery tube 11 being folded back, but can be directly penetrated along the axial direction X of the delivery tube 11, which simplifies the process of penetrating the bending wire 10 and avoids unnecessary damage to the inner wall of the delivery tube 11 caused by the bending wire 10 during the process of penetrating into or out of the inner wall of the delivery tube 11.

[0064] For further information, please refer to Figure 10 to Figure 11The connecting end surface 142 of the return ring 14 and the delivery tube 11 also has a groove 141, and the groove 141 is provided with return holes 13 at both ends of the return ring 14 along the circumferential direction Y. The bending wire 10 passes through the inner wall of the delivery tube 11 from one of the return holes 13, and passes through the inner wall of the delivery tube 11 from the other return hole 13. The groove 141 is used to accommodate the bending wire 10 located outside the delivery tube 11. Furthermore, the return ring 14 is coaxially arranged with the delivery tube 11; and the groove 141 and the wire avoidance hole 15 are arranged along the axial direction X of the delivery tube 11. With such configuration, the folded section formed by the bending adjustment wire 10 between the two return holes 13 is accommodated in the groove 141, so as to avoid the folded section being accommodated on the surface of the connecting end face 142, thereby affecting the connection strength between the return ring 14 and the delivery tube 11; at the same time, the return ring 14 and the delivery tube 11 are coaxially arranged, which improves the bending consistency of the valve prosthesis 12 and the delivery tube 11 during the bending process, and further ensures the coaxial effect between the valve prosthesis 12 and the native valve ring; in addition, the groove 141 and the wire avoidance hole 15 are arranged at intervals along the axis 23 parallel to the axial direction X of the delivery tube 11, so as to ensure that the bending adjustment wire 10 can fold back from the groove 141 and extend along the axial direction X of the delivery tube 11 to pass through the inner wall of the sheath section 111 at the wire avoidance hole 15, so as to further reduce the damage of the bending adjustment wire 10 to the delivery tube 11 during the bending process. It should be noted that in Figure 10 to Figure 11 In the illustrated example, the groove 141 is only provided on one side of the connecting end surface 142. In other embodiments, the groove 141 may also be provided on both sides of the connecting end surface 142. Accordingly, a plurality of bending adjustment wires 10 may be provided and connected to different components that need to be bent. Figure 10 to Figure 11 In the illustrated embodiment, the bending wire 10 is located between the first inner layer 1111 and the first intermediate layer 1112 of the sheath tube section 111, and between the second inner layer 1121 and the second intermediate layer 1122 of the outer tube section 112. Figure 6 As well as the corresponding description above, this embodiment will not be repeated here.

[0065] As another alternative embodiment, please refer to Fig.12The bending adjustment wire 10 is located between the first middle layer 1112 and the first outer layer 1113 of the sheath tube segment 111, and between the second inner layer 1121 and the second middle layer 1122 of the outer tube segment 112; in order to prevent the bending adjustment wire 10 from cutting the first outer layer 1113 (polymer material layer) and escaping therefrom during the bending adjustment process, a fixing wire 16 is wound around the outer side of the delivery tube 11; at the same time, the return hole 13 is arranged on the connecting end face 142 of the return ring 14 and the delivery tube 11, and the return section of the bending adjustment wire 10 is accommodated in the groove 141 of the connecting end face 142; in addition, the return ring 14 is coaxially arranged with the delivery tube 11, and the groove 141 and the wire avoidance hole 15 are arranged at intervals along the axis 23 parallel to the axial direction X of the delivery tube 11. In this configuration, the bending wire 10 is folded back at the distal end of the delivery tube 11 to form an action point, which shortens the axial distance between the action point and the valve prosthesis 12, and also prevents the bending wire 10 from damaging the inner wall of the delivery tube 11 during the bending process, thereby improving the safety performance of the entire delivery system. Figure 6 and Fig.11 As well as the corresponding description above, this embodiment will not be repeated here.

[0066] In summary, in the delivery component and delivery system provided in the embodiments of the present invention, the delivery component includes: a bending adjustment wire and a delivery tube; the delivery tube includes a sheath section and an outer tube section, the sheath section is located at the distal end of the outer tube section, the sheath section covers at least a portion of the outer tube section, and the sheath section is used to cover a valve prosthesis; the bending adjustment wire is arranged parallel to the axial direction of the delivery tube and penetrates the inner wall of the delivery tube, the bending adjustment wire is folded back at the distal end of the sheath section, and is used to drive the delivery tube to bend during the process of delivering the valve prosthesis.

[0067] In this configuration, the bending wire is passed through the inner wall of the delivery tube and folded back at the distal end of the sheath section, so that the action point of the bending wire is located at the distal end of the sheath section. At the same time, the sheath section covers the valve prosthesis, shortening the axial distance between the action point of the bending wire and the valve prosthesis, effectively ensuring the coaxial effect of the valve prosthesis and the native valve ring;

[0068] Furthermore, the handle part is respectively connected to the catheter part and the bending adjustment wire to drive the conveying component and / or the catheter component to move along its own axial direction, drive the catheter component to rotate around its own axis, and drive the conveying component to bend through the bending adjustment wire, so that the conveying system provided in the present application can simultaneously meet the two functional requirements of circumferential positioning and bending adjustment.

[0069] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. A conveying assembly, characterized in that: include: Adjust the bending wire and conveying tube; The delivery tube comprises a sheath tube section and an outer tube section, wherein the sheath tube section is located at the distal end of the outer tube section, the sheath tube section covers at least a portion of the outer tube section, and the sheath tube section is used to cover the valve prosthesis; The bending adjustment wire is arranged parallel to the axial direction of the delivery tube and penetrates the inner wall of the delivery tube. The bending adjustment wire is folded back at the distal end of the sheath tube segment and is used to drive the delivery tube to bend during the process of delivering the valve prosthesis.

2. The conveying assembly according to claim 1, characterized in that The distal end of the sheath section is provided with a plurality of back-through holes, which are arranged at intervals along the circumference of the delivery tube. The bending adjustment wire passes through the inner wall of the delivery tube from one of the back-through holes and passes through the inner wall of the delivery tube from another back-through hole.

3. The conveying assembly according to claim 2, characterized in that A wire avoidance hole is provided at the proximal end of the sheath tube segment, and the wire avoidance hole is used for allowing the bending wire to pass through the inner wall of the sheath tube segment.

4. The conveying assembly according to claim 1, characterized in that The delivery assembly also includes a back-through ring coaxially arranged with the delivery tube. The back-through ring is arranged at the distal end of the sheath tube section and connected to the delivery tube. The back-through hole is arranged on the connecting end surface of the back-through ring and the delivery tube.

5. The conveying assembly according to claim 4, characterized in that The connecting end surface of the back-penetration ring and the conveying tube is also provided with a groove, and the back-penetration holes are provided at both ends of the groove along the circumference of the back-penetration ring. The bending adjustment wire passes through the inner wall of the conveying tube from one of the back-penetration holes and passes through the inner wall of the conveying tube from the other back-penetration hole. The groove is used to accommodate the bending adjustment wire located on the outside of the conveying tube.

6. The conveying assembly according to claim 5, characterized in that A wire avoidance hole is provided at the proximal end of the sheath tube segment. The wire avoidance hole and the groove are arranged at intervals along an axis parallel to the axial direction of the delivery tube. The wire avoidance hole is used for allowing the bending wire to pass through the inner wall of the sheath tube segment.

7. The conveying assembly according to claim 2 or 4, characterized in that: The sheath tube segment comprises a first inner layer, a first middle layer and a first outer layer which are arranged in sequence from the inside to the outside, and the bending adjustment wire is located between the first inner layer and the first middle layer.

8. The conveying assembly according to claim 2 or 4, characterized in that: The sheath tube segment comprises a first inner layer, a first middle layer and a first outer layer which are arranged in sequence from inside to outside, and the bending adjustment wire is located between the first middle layer and the first outer layer.

9. The conveying assembly according to claim 8, characterized in that The delivery component also includes a fixing wire, which is wound around the outside of the delivery tube.

10. The conveying assembly according to claim 8, characterized in that The first inner layer includes a PTFE layer, the first middle layer includes a cutting structure, and the first outer layer includes a polymer material layer.

11. The conveying assembly according to claim 1, characterized in that The sheath segment has a first inner layer, a first middle layer and a first outer layer arranged in sequence from the inside to the outside, the first middle layer is a cutting structure, and the cutting structure is composed of a plurality of groups of incisions arranged at intervals along the circumference of the delivery tube, and the distance between two adjacent incisions along the circumference of the delivery tube gradually increases from the distal end of the sheath segment to the proximal end of the sheath segment.

12. The conveying assembly according to claim 1, characterized in that The outer tube section comprises a second inner layer, a second middle layer and a second outer layer which are arranged in sequence from the inside to the outside, and the bending adjustment wire is located between the second inner layer and the second middle layer.

13. The conveying assembly according to claim 12, characterized in that The second inner layer includes a PTFE layer, the second middle layer includes a woven structure, and the second outer layer includes a polymer material layer.

14. A conveying system, characterized in that: include: A handle portion, a catheter portion, and a valve prosthesis; The catheter portion comprises a catheter assembly and a delivery assembly as claimed in any one of claims 1 to 13, the delivery tube covers the catheter assembly, and the valve prosthesis is located between the delivery tube and the catheter assembly; The handle portion is connected to the catheter portion, and is used to drive the delivery assembly and / or the catheter assembly to move along its own axial direction; or drive the catheter assembly to rotate around its own axis; The handle is connected to the bending wire and is used to drive the delivery component to bend through the bending wire during the delivery of the valve prosthesis.

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