Delivery device and catheter system thereof

Abstract

The invention relates to a conveying device and a catheter system thereof, the catheter system comprises a bend adjusting pipe and a plurality of catheters which are sleeved inside and outside with the bend adjusting pipe, the bend adjusting pipe comprises a first pipe section, a second pipe section and a third pipe section which are sequentially connected in the axial direction, and the first pipe section, the second pipe section and the third pipe section can be connected with at least one traction wire; the first pipe section and the third pipe section are respectively used for controlling the bending direction of the catheter under the traction of the corresponding traction wires, the catheter can move along the bending adjusting pipe, and the bending direction of the first pipe section and the bending direction of the third pipe section are both perpendicular to the bending direction of the second pipe section. According to the conveying device and the catheter system thereof, bending control operation is easy and convenient, the overall length of the catheter system cannot be increased, the good bending control effect is maintained, the implant loading, conveying and releasing effects are guaranteed, and the surgical risk is effectively reduced.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a delivery device and a catheter system thereof. Background Art

[0002] Tricuspid annular dilatation is generally more common in patients with heart enlargement. Once the heart enlarges and the valve annulus dilatates, it will cause incomplete closure of the atrioventricular valve or the aortic valve or the pulmonary valve, which will trigger a series of related symptoms of heart failure.

[0003] Valve replacement is a surgery to correct valvular insufficiency caused by a relatively large valve ring. It is often used to treat mitral or tricuspid regurgitation. The artificial valve prosthesis is delivered to the desired position through a delivery device, and the valve prosthesis is implanted to replace the native valve. In transfemoral tricuspid valve replacement, due to the complex anatomical position of the tricuspid valve, after the delivery device delivers the artificial valve prosthesis to the vicinity of the right atrium through the inferior vena cava, the catheter system needs to be bent in multiple sections and directions so that the valve prosthesis in the catheter can be accurately aligned with the position of the native valve, and then the valve prosthesis can be accurately released to the desired position. Therefore, there are great challenges to the bendability and flexibility of the catheter system.

[0004] However, in the related art, the tubes of the catheter system are very rigid. When the delivery device is used to implant the valve prosthesis through the catheter system, the catheter system is difficult to adapt to the complex environment near the tricuspid valve tissue and is prone to scratching blood vessels and other tissues, which increases the difficulty for the operator to operate the delivery device and affects the safety of the operation. Summary of the invention

[0005] Based on this, a delivery device and a catheter system thereof are provided to solve the problem of how to reduce the operational difficulty during implantation and improve the safety of the operation.

[0006] On the one hand, the present application provides a catheter system, including a bending adjustment tube and multiple catheters connected to the bending adjustment tube inside and outside, the bending adjustment tube includes a first tube segment, a second tube segment and a third tube segment connected in sequence along the axial direction, the first tube segment, the second tube segment and the third tube segment can be connected to at least one traction wire, and are respectively used to control the bending direction of the catheter under the traction of the corresponding traction wire, wherein the catheter can move along the bending adjustment tube, and the bending directions of the first tube segment and the third tube segment are perpendicular to the bending direction of the second tube segment.

[0007] In one embodiment, the first pipe segment, the second pipe segment and the third pipe segment are each provided with a plurality of grooves spaced apart along the axial direction, and the grooves located in the first pipe segment and the third pipe segment are both rotated 90° around the axial direction of the bending pipe relative to the grooves located in the second pipe segment.

[0008] In one of the embodiments, main ribs are respectively provided at both ends of the length direction of the groove, and the extension direction of the main ribs is parallel to the center line of the bending adjustment tube. Connecting ribs are respectively provided in the width direction of the groove, and the connecting ribs are arranged around the axial direction of the bending adjustment tube and the two ends are respectively vertically connected between the two main ribs.

[0009] In one embodiment, any two circumferentially adjacent grooves are arranged to be rotated 180°.

[0010] In one embodiment, at least one of the following technical solutions is also included:

[0011] All the connecting ribs located in the first pipe section are of equal length and are evenly arranged along the axial direction of the first pipe section;

[0012] Alternatively, all the connecting ribs located in the second pipe segment are of equal length and are evenly arranged along the axial direction of the second pipe segment;

[0013] Alternatively, all the connecting ribs located in the third pipe segment are of equal length and are evenly arranged along the axial direction of the third pipe segment.

[0014] In one embodiment, a first connecting ring is provided at the distal end of the first tube segment, a second connecting ring is provided between the second tube segment and the first tube segment, a third connecting ring is connected between the third tube segment and the second tube segment, the traction wire comprises a first traction wire, a second traction wire and a third traction wire, the first traction wire is connected to the first connecting ring, and is used to pull the first tube segment to bend in a first plane via the first connecting ring, the second traction wire is connected to the second connecting ring, and is used to pull the second tube segment to bend in a second plane via the second connecting ring, the third traction wire is connected to the third connecting ring, and is used to pull the third tube segment to bend in the third plane via the third connecting ring, wherein the first plane and the third plane are both perpendicular to the second plane.

[0015] In one embodiment, the catheter includes an inner core tube and an inner tube and an outer tube which are sequentially sleeved on the outside of the inner core tube, the bending adjustment tube is sleeved between the inner tube and the outer tube, and the inner tube and the outer tube can both move axially relative to the bending adjustment tube, the outer tube has a receiving cavity for loading an implant, and the inner core tube and the inner tube are used to operate the implant to release from the receiving cavity and to operate the implant to be recovered into the receiving cavity.

[0016] In one embodiment, the inner tube has a plurality of hollow grooves, which extend along the circumference of the inner tube, and along the axial direction of the inner tube, the hollow grooves and adjacent hollow grooves are staggered by 90° around the axial direction of the inner tube.

[0017] In one embodiment, the inner tube includes a first part and a second part connected to each other, the second part is connected to the proximal end of the first part, and the spacing between the hollow grooves in the first part is greater than the spacing between the hollow grooves in the second part.

[0018] In one embodiment, the arc of the hollow groove extending along the circumference of the inner tube is 60° to 120°.

[0019] In one embodiment, the arc of the hollow groove extending along the circumference of the inner tube is 90°.

[0020] On the other hand, the present application provides a conveying device, including an operating handle and the above-mentioned catheter system, wherein the operating handle is connected to the proximal end of the catheter system, and the operating handle is used to pull the bending adjustment tube to bend through the traction wire, and to control the axial and / or axial movement of the catheter relative to the bending adjustment tube.

[0021] In the above-mentioned delivery device and catheter system thereof, the bending adjustment tube of the catheter system includes a first tube segment, a second tube segment and a third tube segment, and the bending directions of the first tube segment and the third tube segment are both perpendicular to the bending direction of the second tube segment. Since the first tube segment and the third tube segment are located at both ends of the second tube segment, and the bending directions are both perpendicular to the bending direction of the second tube segment, the bending adjustment tube can be used to achieve three-dimensional bending in space. In this way, the bending adjustment tube can adjust the catheter to a suitable posture, so that the implant can be transported along the catheter to a complex implantation environment, reducing the difficulty of implantation operation and improving surgical safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, drawings of other embodiments can be obtained based on these drawings without paying any creative work.

[0023] Figure 1 It is a schematic diagram of the cross-sectional structure of the distal end of the catheter system of the delivery device according to one embodiment of the present application.

[0024] Figure 2 This is a schematic diagram of the cross-sectional structure of an outer tube in a catheter system of a delivery device according to one embodiment.

[0025] Figure 3 It is a schematic structural diagram of a catheter system of a delivery device according to one embodiment when an implant is loaded.

[0026] Figure 4 This is a schematic structural diagram of a catheter system of a delivery device according to an embodiment when an implant is removed from the distal end of an outer tube.

[0027] Figure 5 It is a schematic structural diagram of a bending tube in a catheter system of a conveying device according to one embodiment.

[0028] Figure 6 for Figure 5 The diagram shows a partially enlarged structural diagram of the bending adjustment pipe of the catheter system at the connection between the first pipe section and the second pipe section.

[0029] Figure 7 for Figure 5 The diagram shows a partially enlarged structural diagram of the bending adjustment pipe of the catheter system at the connection between the second pipe section and the third pipe section.

[0030] Figure 8 It is a schematic structural diagram of an inner tube in a catheter system of a delivery device according to one embodiment.

[0031] Fig. 9 for Figure 8 A schematic diagram of the partially enlarged structure of the first portion of the inner tube of the catheter system is shown.

[0032] Fig.10 for Figure 8 A schematic diagram of the partially enlarged structure of the second portion of the inner tube of the catheter system is shown.

[0033] Fig.11 This is a schematic structural diagram of an embodiment of a delivery device in which the distal end of the catheter system remains coaxial with the tricuspid valve annulus.

[0034] Reference numerals:

[0035] 10. catheter system; 11. bending pipe; 11a. groove; 11b. main rib; 11c. connecting rib; 111. first pipe section; 112. second pipe section; 113. third pipe section; 114. first connecting ring; 114a. first connecting part; 115. second connecting ring; 115a. second connecting part; 116. third connecting ring; 116a. third connecting part; S1. first traction wire; S2. second traction wire; S3 , third traction wire; 12, inner core tube; 121, guide head; 13, inner tube; 13a, fixing head; 13b, hollow groove; C1, first groove; C2, second groove; J1, first rib; J2, second rib; 131, first part; 132, second part; 13b, second roller; 14, outer tube; 14a, receiving cavity; 141, proximal catheter; 142, distal catheter; W, implant; T, tricuspid valve ring; H, ventricle. DETAILED DESCRIPTION

[0036] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0037] In the embodiments of the present application, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0038] In this application, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0039] It should be noted that "distal" and "proximal" are used as directional terms, which are commonly used terms in the field of interventional medical devices, where "distal" refers to the end away from the operator (such as the doctor) during the operation, and "proximal" refers to the end close to the operator during the operation. Axial refers to the direction in which the central axis of the medical device extends; radial refers to the direction perpendicular to the above-mentioned axial direction; circumferential refers to the direction around the above-mentioned axial direction.

[0040] See also Figure 1 As shown, Figure 1 A cross-sectional structural diagram of the distal end of the delivery-loaded catheter system 10 is schematically given. A delivery device provided in an embodiment of the present application is used to input an implant W. The delivery device includes a catheter system 10 and an operating handle (not shown). The implant W can be a valve prosthesis, which is composed of a self-expandable metal stent and a leaflet made of a polymer material. The self-expanding metal stent can be made of nickel-titanium alloy, using a laser cutting process or woven from nickel-titanium alloy wire. The polymer leaflet can be pure polyurethane or a composite material composed of polyurethane and a braid. The structure of the valve prosthesis is not limited here.

[0041] When the valve prosthesis is delivered by the delivery device, the valve prosthesis can be first loaded into the catheter system 10, and the valve prosthesis can be pushed to the position where it needs to be implanted by performing interventional surgery using the catheter system 10. In this process, it is necessary to use an operating handle to bend the catheter system 10, and to operate the catheter in the catheter system 10 to move axially or around the axial direction, so as to release the valve prosthesis to the position where it needs to be implanted. Interventional surgery is a common diagnostic and treatment method for treating diseases such as cardiovascular blockage, and the implantation operation of implant W is a very mature technology. Therefore, in the embodiment of the present application, the implantation operation process of implant W will not be described in detail.

[0042] Continue to combine Figure 1 As shown, the catheter system 10 includes a bend adjustment tube 11 and a plurality of catheters, and the plurality of catheters are connected to the bend adjustment tube 11 in an inner and outer manner. Regarding the connection relationship between the catheter and the bend adjustment tube 11, the catheter can be sleeved outside the bend adjustment tube 11, or the bend adjustment tube 11 can be sleeved outside the catheter, which is not limited here. As long as the bend adjustment tube 11 and the plurality of catheters are connected in an inner and outer manner, the use requirements of the catheter system 10 can be met. For example, one of the catheters is sleeved outside the bend adjustment tube 11, and the bend adjustment tube 11 is sleeved outside another catheter. For another example, the bend adjustment tube 11 is sleeved outside one of the catheters, and another catheter is sleeved outside the catheter. In the catheter system 10, the number of catheters is not limited here. For ease of understanding, the catheter system 10 that meets the needs of implant W delivery and release is taken as an example below to explain the catheters of the catheter system 10, but the number and function of the catheters of the catheter system 10 are not limited.

[0043] In some embodiments, the catheter includes an inner core tube 12 and an inner tube 13 and an outer tube 14 which are sequentially sleeved on the outer side of the inner core tube 12. In this embodiment, the bending adjustment tube 11 is sleeved between the inner tube 13 and the outer tube 14, and both the inner tube 13 and the outer tube 14 can move axially relative to the bending adjustment tube 11, and the outer tube 14 has a receiving cavity 14a for loading the implant W, and the inner core tube 12 and the inner tube 13 are used to operate the implant W to be released from the receiving cavity 14a. It can be understood that the implant W can also be recovered into the receiving cavity 14a by operating the inner core tube 12 and the inner tube 13, that is, the recovery operation of the implant W is realized.

[0044] In this embodiment, the inner diameter of the portion of the outer tube 14 used to accommodate the implant W (i.e., the portion of the tube corresponding to the accommodating cavity 14a) can be designed to be larger than that of other portions of the tube, so that the implant W can be more easily loaded into the accommodating cavity 14a of the outer tube 14. Figure 2 As shown, Figure 2 A cross-sectional view of the outer tube 14 is schematically shown. The outer tube 14 includes a proximal catheter 141 and a distal catheter 142, wherein the distal catheter 142 is connected to the distal end of the proximal catheter 141, and a receiving cavity 14a is formed in the distal catheter 142. The distal catheter 142 is then used to meet the loading requirements of the implant W. The distal catheter 142 can be made of a combination of a cut metal tube and a polymer material, or can be made of a polymer material alone, which is not limited here. Accordingly, the proximal catheter 141 can be made of a combination of a cut metal tube and a polymer material, or can be made of a polymer material alone.

[0045] It should be noted that the distal end of the inner core tube 12 can be connected to a guide head 121, so that when the catheter system 10 passes through a location such as a vascular tissue, the guide head 121 can play a guiding effect and reduce damage to the tissue. The guide head 121 can be made of a polymer material. The connection method between the guide head 121 and the inner core tube 12 includes but is not limited to welding, melting or bonding.

[0046] During the implant W delivery phase, the guide head 121 can also block the distal end of the receiving cavity 14a to prevent blood from entering the receiving cavity 14a and causing thrombosis. Figure 3 As shown, the proximal end of the implant W is connected to the fixed head 13a at the distal end of the inner tube 13, and the implant W is compressed and accommodated in the receiving cavity 14a of the outer tube 14, and the guide head 121 blocks the distal end of the receiving cavity 14a under the traction of the inner core tube 12. Figure 4 As shown, when the implant W needs to be released, the implant W can be removed from the distal end of the receiving cavity 14a by driving the inner core tube 12 and the inner tube 13 to move toward the distal end relative to the outer tube 14.

[0047] It should be noted that the bending adjustment tube 11 may not be arranged between the inner tube 13 and the outer tube 14. In some embodiments, the bending adjustment tube 11 may also be arranged between the inner core tube 12 and the inner tube 13. As long as the bending adjustment tube 11 is arranged between two conduits, the bending of the conduit can be controlled by the bending of the bending adjustment tube 11. Of course, it can be understood that the conduit that can be controlled to bend by the bending adjustment tube 11 must be a pipe that has the ability to be bent by external force to meet the bending requirements.

[0048] Combination Figure 5 As shown, the bending adjustment tube 11 includes a first tube segment 111, a second tube segment 112, and a third tube segment 113 connected in sequence along the axial direction. The first tube segment 111, the second tube segment 112, and the third tube segment 113 can all be connected to at least one traction wire, and are respectively used to control the bending direction of the catheter under the traction of the corresponding traction wire. It can be understood that the catheters such as the inner tube 13 and the outer tube 14 can move along the bending adjustment tube 11.

[0049] In the embodiment of the present application, the bending directions of the first tube segment 111 and the third tube segment 113 are both perpendicular to the bending direction of the second tube segment 112. Since the first tube segment 111 and the third tube segment 113 are located at both ends of the second tube segment 112, and the bending directions are both perpendicular to the bending direction of the second tube segment 112, the bending adjustment tube 11 can be used to achieve three-dimensional bending in space. In this way, the bending adjustment tube 11 can adjust the catheter to a suitable posture, so that the implant W can be transported to a complex implantation environment along the catheter. Taking the implant W as a valve prosthesis for implantation at the location of the mitral valve or tricuspid valve as an example, after the catheter system 10 is inserted into the human body, the catheter system 10 is adjusted to adapt the valve prosthesis to enter the location of the tricuspid valve by adjusting the bending adjustment tube 11. At this time, the corresponding tube segments (the first tube segment 111, the second tube segment 112 and the third tube segment 113) are pulled by the traction wire to fix the overall posture of the bending adjustment tube 11. At this time, the catheter that needs to be moved is moved along the bending tube 11, so that the valve prosthesis can be accurately implanted to the location of the tricuspid valve. In this process, since the bending tube 11 can achieve multiple sections of vertical bending, it can be adjusted to maintain a coaxial posture with the tricuspid valve ring. Therefore, after the catheter transports the valve prosthesis to the location of the tricuspid valve along the bending tube 11, the support and guidance of the catheter by the bending tube 11 can maintain the coaxiality of the valve prosthesis with the tricuspid valve ring when it is released, thereby improving the surgical effect. Moreover, based on the support and guidance of the catheter by the bending tube 11, the movement of the catheter is smooth and reliable, which is conducive to controlling the distance between the valve prosthesis transported by the catheter and the tricuspid valve, and then achieving the effect of accurately controlling the implantation position.

[0050] It should be noted that during the process of bending the bending tube 11, the first tube segment 111, the second tube segment 112 and the third tube segment 113 can be bent together in linkage, or they can be bent independently, thereby providing two bending modes. For example, the first tube segment 111, the second tube segment 112 and the third tube segment 113 are driven to bend by their respective traction wires at the same time, so that each tube segment is bent in linkage. For another example, when only the first tube segment 111 is required to be bent, the traction wire connected to the second tube segment 112 and the third tube segment 113 is controlled to remain stationary, and the traction wire connected to the first tube segment 111 is used to apply traction to the first tube segment 111, so that the first tube segment 111 bends independently. Correspondingly, the second tube segment 112 and the third tube segment 113 can also be bent independently under the traction of their respective traction wires. The bending process of the bending tube 11 is not limited here, as long as the bending tube 11 can be bent to a suitable shape to meet the catheter to transport the implant W to a suitable implantation position for release.

[0051] Since the bending tube 11 provides two bending forms, the operator can operate one of the first tube segment 111, the second tube segment 112 and the third tube segment 113 to bend independently, or operate two or three of the tube segments to bend simultaneously. Therefore, the operator can select a suitable operation mode as needed to reduce the operator's operation of rotating the conveying device. The operator can choose between these two modes to adapt to different surgical conditions. Among them, the linkage bending mode can simplify the bending operation, optimize the operation logic, and be more operator-friendly; the independent bending mode can be fine-tuned in a certain direction of the space to make the release of the implant W more accurate and improve the safety of the operation.

[0052] Combination Figure 6 and Figure 7 As shown, the first pipe segment 111, the second pipe segment 112 and the third pipe segment 113 are all provided with a plurality of grooves 11a spaced apart in the axial direction, and the grooves 11a located in the first pipe segment 111 and the third pipe segment 113 are all arranged to be rotated 90° around the axial direction of the adjustment bend pipe 11 relative to the grooves 11a located in the second pipe segment 112. It should be noted that the grooves 11a can provide an escape space for the bending of the adjustment bend pipe 11, so that the position of the adjustment bend pipe 11 corresponding to the grooves 11a can rotate around the line connecting the two ends of the grooves 11a. Based on this, the positions of the grooves 11a on the first pipe segment 111, the second pipe segment 112 and the third pipe segment 113 on the corresponding circumference determine the bending performance of the corresponding pipe segment in a specific direction. Since the grooves 11a located in the first pipe section 111 and the third pipe section 113 are rotated 90° around the axial direction of the bending pipe 11 relative to the groove 11a located in the second pipe section 112, the bending direction of the first pipe section 111 and the third pipe section 113 is perpendicular to the bending direction of the second pipe section 112.

[0053] It should be noted here that the groove 11a can be formed by cutting the tube body. For example, the groove 11a is cut at the corresponding position of the tube body by laser cutting to form the bending adjustment tube 11 including the first tube segment 111, the second tube segment 112 and the third tube segment 113. Of course, in some embodiments, the plate can also be cut according to a preset pattern to form a plate with hollowing. In this way, the plate is rolled into a tube so that the hollow positions correspond to the grooves 11a of the first tube segment 111, the grooves 11a of the second tube segment 112 and the grooves 11a of the third tube segment 113, respectively, and the bending adjustment tube 11 including the first tube segment 111, the second tube segment 112 and the third tube segment 113 can be obtained.

[0054] The manufacturing process of the bending adjustment tube 11 is not limited here. Figure 6 and Figure 7 As shown, the circumferential sides of the first pipe segment 111, the second pipe segment 112 and the third pipe segment 113 are all provided with grooves 11a opposite to each other in pairs, and the corresponding positions of the grooves 11a located in different pipe segments on the circumferential sides are different. To be specific, the setting positions of the grooves 11a on the first pipe segment 111 and the grooves 11a on the third pipe segment 113 are consistent, and both are rotated 90° with the grooves 11a on the second pipe segment 112.

[0055] The groove 11a may be an arc groove, that is, the groove 11a extends in an arc shape on the circumference of the bending adjustment tube 11. It should be noted that the arc groove is only one implementation method of grooving the bending adjustment tube 11 to improve the bending performance. In some implementations, the groove 11a may be V-shaped, W-shaped, or wavy along the circumference of the bending adjustment tube 11 to meet the needs of bending different sections of the bending adjustment tube 11 in different directions. The shape of the groove 11a is not limited here.

[0056] Combination Figures 5 to 7 As shown, in some embodiments, main ribs 11b are respectively provided at both ends of the length direction of the groove 11a, and the extension direction of the main ribs 11b is parallel to the center line of the bending tube 11. Connecting ribs 11c are respectively provided in the width direction of the groove 11a, and the connecting ribs 11c are arranged around the axial direction of the bending tube 11 and the two ends are respectively vertically connected between the two main ribs 11b. With this structural arrangement, the bending tube 11 can not only improve the bending performance by using the groove 11a, but also provide sufficient radial support performance for the bending tube 11 by using the main ribs 11b and the connecting ribs 11c connected between the main ribs 11b, so that when the bending tube 11 is used to guide the catheter into the implantation position, the bending tube 11 can stably lock the guiding direction, thereby improving the stability of the implantation operation of the implant W.

[0057] Furthermore, combined with Figure 6 and Figure 7As shown, any two circumferentially adjacent grooves 11a are arranged to be rotated 180°. It can be understood that since the connecting rib 11c is provided in the width direction of the groove 11a, and the two ends of the connecting rib 11c are respectively vertically connected between the two main ribs 11b, any two adjacent connecting ribs 11c are also arranged to be rotated 180° in the circumferential direction of the bending adjustment tube 11. Through this structural setting, the surface where the two main ribs 11b connected to the two ends of the connecting rib 11c are located is used as the reference surface, and the connecting ribs 11c are distributed on both sides of the reference surface. Therefore, no matter which side the bending adjustment tube 11 bends, the other side has good radial support performance, thereby improving the bending stability of the bending adjustment tube 11 as a whole, which is beneficial to the support and guiding effect of the bending adjustment tube 11 on the catheter, so that the implant W can be stably transported to the position where it needs to be implanted by the catheter system 10 and stably released, thereby improving the safety of the surgical operation.

[0058] It should be noted that, for the pipe fittings such as the catheter and the bending pipe 11 in the catheter system 10 of the present application, the pipe fittings are round pipes with uniform diameters. Or, in order to meet the needs of, for example, accommodating the implant W, the diameter of some catheters can be increased at the position corresponding to the implant W. But overall, these pipe fittings are round pipes with uniform diameters.

[0059] In the embodiment of the present application, the connecting ribs 11c of the bending adjustment pipe 11 cooperate with the main ribs 11b to form the grooves 11a of the bending adjustment pipe 11, so as to take into account the bending performance and support performance of the bending adjustment pipe 11. Based on this, the length and arrangement of the connecting ribs 11c are related to the bending performance and support performance of the corresponding pipe section of the bending adjustment pipe 11.

[0060] The inventors have found through research that the following configuration can fully utilize the bending performance of the bending adjustment tube 11 and improve the stability of the bending adjustment tube 11 in supporting other conduits.

[0061] Combination Figure 5 and Figure 6As shown, taking the first pipe segment 111 as an example, the lengths of all the connecting ribs 11c located in the first pipe segment 111 are equal, and they are evenly arranged along the axial direction of the first pipe segment 111. Under this structural setting, the widths of the slots 11a between any adjacent connecting ribs 11c are consistent, so that the bent parts of the first pipe segment 111 can be flexibly and naturally bent. At the same time, the connecting ribs 11c of the first pipe segment 111 can transfer the radial extrusion force to the main ribs 11b, so that the arc-shaped curved connecting ribs 11c can provide a sufficiently strong supporting force. In this way, the first pipe segment 111 has good bending performance and is not easily crushed by the radial extrusion force, so that the stability of the catheter when it moves along the axial direction of the first pipe segment 111 can be improved, so that when the implant W is transported and released by the catheter, the implant W can maintain a stable moving direction, so as to control the accuracy of the implant W to be released to the required implantation position, thereby improving the convenience and safety of surgical operation.

[0062] Correspondingly, the second pipe section 112 and the third pipe section 113 may also be arranged in a similar manner to the first pipe section 111. All the connecting ribs 11c located in the second pipe section 112 are of equal length and are evenly arranged along the axial direction of the second pipe section 112. Figure 5 and Figure 7 As shown, the lengths of all the connecting ribs 11c located in the third pipe segment 113 are equal and are evenly arranged along the axial direction of the third pipe segment 113. It should be noted that under this structural setting, the structures of the various pipe segments of the bending adjustment pipe 11 are basically the same, except that the positions of the main ribs 11b and the connecting ribs 11c of the second pipe segment 112 are rotated 90° relative to the main ribs 11b of the first pipe segment 111, so that the bending direction of the second pipe segment 112 is perpendicular to the bending direction of the first pipe segment 111. Accordingly, the positions of the main ribs 11b and the connecting ribs 11c of the third pipe segment 113 are rotated 90° relative to the main ribs 11b of the second pipe segment 112.

[0063] Combination Figures 5 to 7As shown, a first connecting ring 114 is provided at the distal end of the first pipe segment 111, a second connecting ring 115 is provided between the second pipe segment 112 and the first pipe segment 111, and a third connecting ring 116 is connected between the third pipe segment 113 and the second pipe segment 112. Accordingly, the traction wire used to pull the bending adjustment pipe 11 includes a first traction wire S1, a second traction wire S2 and a third traction wire S3. The first traction wire S1 is connected to the first connecting ring 114, and is used to pull the first pipe segment 111 to bend in the first plane through the first connecting ring 114. The second traction wire S2 is connected to the second connecting ring 115, and is used to pull the second pipe segment 112 to bend in the second plane through the second connecting ring 115. The third traction wire S3 is connected to the third connecting ring 116, and is used to pull the third pipe segment 113 to bend in the third plane through the third connecting ring 116. Since the bending directions of the first tube segment 111 and the third tube segment 113 are both perpendicular to the bending direction of the second tube segment 112 , the first plane and the third plane are perpendicular to the second plane.

[0064] In this embodiment, different traction wires are used to pull the corresponding pipe sections respectively, so that the bending tube 11 as a whole can be bent in any shape in three-dimensional space, so as to reduce the difficulty of implanting the implant W and improve the safety of the operation.

[0065] A first connection portion 114a is provided at the intersection of the first connection ring 114 and the first plane, and the first traction wire S1 is connected to the first connection portion 114a. When the first traction wire S1 is used to pull the first connection portion 114a, the first tube segment 111 will bend in the first plane. Since the first connection portion 114a is located in the first plane, the point where the first traction wire S1 applies traction force to the first connection ring 114 is located in the first plane, so as to improve the flexibility of the first traction wire S1 in controlling the bending of the first tube segment 111 in the first plane, making the operation easier.

[0066] A second connection portion 115a is provided at the intersection of the second connection ring 115 and the second plane, and the second traction wire S2 is connected to the second connection portion 115a. When the second connection portion 115a is pulled by the second traction wire S2, the second tube segment 112 will bend in the second plane. Since the second connection portion 115a is located in the second plane, the point where the second traction wire S2 applies traction force to the second connection ring 115 is located in the second plane, so as to improve the flexibility of the second traction wire S2 in controlling the bending of the second tube segment 112 in the second plane, making the operation easier.

[0067] A third connection portion 116a is provided at the intersection of the third connection ring 116 and the third plane, and the third traction wire S3 is connected to the third connection portion 116a. When the third connection portion 116a is pulled by the third traction wire S3, the third tube segment 113 will bend in the third plane. Since the third connection portion 116a is located in the third plane, the point of action of the third traction wire S3 exerting traction force on the third connection ring 116 is located in the third plane, so as to improve the flexibility of the third traction wire S3 in controlling the bending of the third tube segment 113 in the third plane, making the operation easier.

[0068] It should be noted that the first connecting portion 114a, the second connecting portion 115a and the third connecting portion 116a can be used as long as they can meet the connection requirements of the corresponding traction wire. Specifically, these connecting portions can be hook-shaped or can be holes. Figure 6 and Figure 7 As shown, the first connection portion 114a, the second connection portion 115a and the third connection portion 116a are all holes, and for the sake of convenience of distinction, they are respectively referred to as "first hole", "second hole" and "third hole". In this way, the first hole is used to connect the first traction wire S1. The second hole is used to connect the second traction wire S2. The third hole is used to connect the third traction wire S3. It can be understood that under the traction of the first traction wire S1, the first connection ring 114 will drive the first pipe segment 111 to bend toward the side where the first hole is opened. Correspondingly, under the traction of the second traction wire S2, the second connection ring 115 will drive the second pipe segment 112 to bend toward the side where the second hole is opened; under the traction of the third traction wire S3, the third connection ring 116 will drive the third pipe segment 113 to bend toward the side where the third hole is opened.

[0069] Combination Figure 8 and Fig. 9 As shown, in some embodiments, the inner tube 13 has a plurality of hollow grooves 13b, which extend along the circumference of the inner tube 13, so that the inner tube 13 is easy to bend. In this embodiment, along the axial direction of the inner tube 13, the hollow grooves 13b and the adjacent hollow grooves 13b are staggered 90° around the axial direction of the inner tube 13. With this structural arrangement, the inner tube 13 can maintain good compressive strength in the radial direction while taking into account the bending performance and is not easy to be crushed.

[0070] Combination Figures 8 to 10As shown, the inner tube 13 includes a first part 131 and a second part 132 connected to each other. The second part 132 is connected to the proximal end of the first part 131, and the spacing W1 between the hollow grooves 13b located in the first part 131 is greater than the spacing W2 between the hollow grooves 13b located in the second part 132. Through this structural setting, the second part 132 at the proximal end can be more flexible and easy to bend; accordingly, the first part 131 at the distal end can maintain a high structural strength, and when the implant W is operated at the distal end of the inner tube 13 (i.e., the tube section where the first part 131 is located), the first part 131 has sufficient strength to maintain the stability of the implant W. In this embodiment, based on the different mechanical properties of the inner tube 13 in different sections, such as increasing the strength and reducing the bending performance at some positions (such as the first part 131), and increasing the bending performance and reducing the strength at another position (such as the second part 132), different positions of the inner tube 13 can have different performances to improve the corresponding functions, thereby reducing the number of catheters and increasing the operability and reliability of the catheter system 10.

[0071] In some embodiments, the arc of the hollow groove 13b extending along the circumference of the inner tube 13 is 60° to 120°, specifically 60°, 70°, 80°, 90°, 100°, 110° or 120°. Preferably, the arc of the hollow groove 13b extending along the circumference of the inner tube 13 is 90°. By controlling the arc of the hollow groove 13b extending along the circumference of the inner tube 13 to be 60° to 120°, the radial support strength of the inner tube 13 can be maintained while improving the bending performance, so that when the inner tube 13 and the outer tube 14 move relative to the bending tube 11, the accuracy of the catheter system 10 in operating the implant W to enter the implantation position can be improved.

[0072] The inner tube 13 can be formed by laser cutting of a tube body. Accordingly, the position or shape of the hollow groove 13b has various possibilities, as long as the supporting strength of the inner tube 13 is maintained while the bending performance is improved. Figure 8 As shown, Figure 8A partial enlarged schematic diagram of the inner tube 13 corresponding to the first part 131 is schematically given. The hollow groove 13b is divided into two categories according to its position on the circumference of the inner tube 13, namely the first groove C1 and the second groove C2. Specifically, two sections of the first groove C1 are cut on the circumference of the inner tube 13 by laser, and a first rib J1 is formed between the two first grooves C1. Another two sections of the second groove C2 are cut at a certain distance along the axial direction of the inner tube 13, and the second groove C2 is rotated 90° relative to the first groove C1 in the axial direction of the inner tube 13, and a second rib J2 is formed between the two second grooves C2. It can be understood that the second rib J2 is rotated 90° relative to the first rib J1 in the axial direction of the inner tube 13. By analogy, the first groove C1 and the second groove C2 are alternately arranged along the axial direction of the inner tube 13, that is, they are staggered from each other along the axial direction of the inner tube 13. Correspondingly, the first rib J1 and the second rib J2 are staggered from each other by 90° in the circumferential direction of the inner tube 13, and are staggered from each other in the axial direction of the inner tube 13. This structural setting not only increases the flexibility of the inner tube 13, but also ensures the strength of the inner tube 13, so that the inner tube 13 can withstand radial extrusion.

[0073] It should be noted that in the delivery device of the present application, the operating handle is connected to the proximal end of the catheter system 10. The operating handle is used to pull the bending tube 11 through the traction wire to bend, thereby meeting the bending needs. At the same time, the operating handle is also used to control the catheter to move axially and / or around the axial direction relative to the bending tube 11, thereby meeting the needs of operations such as delivery, release or recovery of the implant W.

[0074] The structural principle of the catheter system 10 will be further described below by taking the implant W as a valve prosthesis as an example.

[0075] Combination Fig.11 As shown, Fig.11 The implant W( Fig.11 A cross-sectional view of the catheter system 10 (not shown in the figure). The valve prosthesis (not shown in the figure) can be loaded and fixed in the receiving cavity 14a of the outer tube 14. Although it is mentioned above that the catheter system 10 includes an inner core tube 12, an inner tube 13 and an outer tube 14, the catheter system 10 provided in the embodiment of the present application is not limited to the above-mentioned catheters. In order to facilitate the understanding of the structural principle of the catheter system 10, the implantation operation of the valve prosthesis is explained here in combination with the inner core tube 12, the inner tube 13 and the outer tube 14. First, the operator pushes the catheter system 10 through the inferior vena cava to the vicinity of the right atrium, and then uses the operating handle to bend the adjustment tube 11 into the shape as shown in the figure. Fig.11The shape of the outer tube 14 makes the valve prosthesis in the receiving cavity 14a of the outer tube 14 axially aligned with the tricuspid valve ring T and remain fixed. The inner core tube 12, the inner tube 13 and the outer tube 14 are operated by the operating handle to move axially along the adjustment bend tube 11, so that the valve prosthesis remains coaxial with the tricuspid valve ring T while moving toward or away from the ventricle H, so that the valve prosthesis is close to the position where it needs to be implanted. After reaching the position where it needs to be implanted, the inner core tube 12 and the inner tube 13 are operated by the operating handle to move toward the distal end of the outer tube 14 to remove the valve prosthesis from the distal end of the outer tube 14. The position of the valve prosthesis can be fine-tuned. After the release condition is reached, the inner core tube 12 and the inner tube 13 are controlled to move relative to each other by the operating handle to release the valve prosthesis to the position of the tricuspid valve ring T, so that the valve prosthesis can be used to replace the native valve for work.

[0076] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0077] The above embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the present application. It should be pointed out that, for a person of ordinary skill in the art, several modifications and improvements can be made without departing from the inventive concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the attached claims.

Claims

1. A catheter system, characterized in that: It includes a bending adjustment tube and multiple catheters connected to the bending adjustment tube inside and outside, the bending adjustment tube includes a first tube segment, a second tube segment and a third tube segment which are connected in sequence along the axial direction, the first tube segment, the second tube segment and the third tube segment can be connected to at least one traction wire, and are respectively used to control the bending direction of the catheter under the traction of the corresponding traction wire, wherein the catheter can move along the bending adjustment tube, and the bending directions of the first tube segment and the third tube segment are perpendicular to the bending direction of the second tube segment.

2. The catheter system according to claim 1, characterized in that The first pipe segment, the second pipe segment and the third pipe segment are all provided with a plurality of grooves spaced apart along the axial direction, and the grooves located in the first pipe segment and the third pipe segment are both arranged to be rotated 90° around the axial direction of the bending pipe relative to the grooves located in the second pipe segment.

3. The catheter system according to claim 2, characterized in that Main ribs are respectively provided at both ends of the length direction of the groove, and the extension direction of the main ribs is parallel to the center line of the bending adjustment tube. Connecting ribs are respectively provided in the width direction of the groove, and the connecting ribs are arranged around the axial direction of the bending adjustment tube and the two ends are respectively vertically connected between the two main ribs.

4. The catheter system according to claim 3, characterized in that Any two circumferentially adjacent cutting grooves are arranged to be rotated 180 degrees.

5. The catheter system according to claim 3 or 4, characterized in that Also includes at least one of the following technical solutions: All the connecting ribs located in the first pipe section are of equal length and are evenly arranged along the axial direction of the first pipe section; Alternatively, all the connecting ribs located in the second pipe segment are of equal length and are evenly arranged along the axial direction of the second pipe segment; Alternatively, all the connecting ribs located in the third pipe segment are of equal length and are evenly arranged along the axial direction of the third pipe segment.

6. The catheter system according to claim 2 or 3, characterized in that A first connecting ring is provided at the distal end of the first tube segment, a second connecting ring is provided between the second tube segment and the first tube segment, a third connecting ring is connected between the third tube segment and the second tube segment, the traction wire comprises a first traction wire, a second traction wire and a third traction wire, the first traction wire is connected to the first connecting ring, and is used to pull the first tube segment to bend in a first plane via the first connecting ring, the second traction wire is connected to the second connecting ring, and is used to pull the second tube segment to bend in a second plane via the second connecting ring, the third traction wire is connected to the third connecting ring, and is used to pull the third tube segment to bend in the third plane via the third connecting ring, wherein the first plane and the third plane are both perpendicular to the second plane.

7. The catheter system according to claim 1, characterized in that The catheter includes an inner core tube and an inner tube and an outer tube which are sequentially sleeved on the outside of the inner core tube, the bending adjustment tube is sleeved between the inner tube and the outer tube, and both the inner tube and the outer tube can move axially relative to the bending adjustment tube, the outer tube has a receiving cavity for loading an implant, the inner core tube and the inner tube are used to operate the implant to release from the receiving cavity, and to operate the implant to be recovered into the receiving cavity.

8. The catheter system according to claim 7, characterized in that The inner tube has a plurality of hollow grooves extending along the circumference of the inner tube, and in the axial direction of the inner tube, the hollow grooves and adjacent hollow grooves are staggered by 90° around the axial direction of the inner tube.

9. The catheter system according to claim 8, characterized in that The inner tube includes a first part and a second part connected to each other, wherein the second part is connected to the proximal end of the first part, and the spacing between the hollow grooves in the first part is greater than the spacing between the hollow grooves in the second part.

10. The catheter system according to claim 8 or 9, characterized in that The arc of the hollow groove extending along the circumference of the inner tube is 60° to 120°.

11. The catheter system according to claim 10, characterized in that The arc of the hollow groove extending along the circumference of the inner tube is 90°.

12. A conveying device, characterized in that: It comprises an operating handle and the catheter system according to any one of claims 1-11, wherein the operating handle is connected to the proximal end of the catheter system, and is used to pull the bending tube to bend via the traction wire, and to control the axial and / or circumaxial movement of the catheter relative to the bending tube.

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