A delivery catheter assembly and a transcatheter valve repair system

Abstract

The present invention provides a delivery catheter assembly and a transcatheter valve repair system. The delivery catheter assembly includes a guide sheath and a bending sheath, the bending sheath is movably inserted into the guide sheath, and a first auxiliary part is convexly provided near the distal end of the bending sheath, and the first auxiliary part at least partially stops at the distal opening of the guide sheath. The delivery catheter assembly and the transcatheter valve repair system of the present invention are provided with a protruding first auxiliary part at the distal end of the bending sheath, and the first auxiliary part at least partially stops at the distal opening of the guide sheath. During treatment, if the implant does not reach the accurate surgical site, the implant can be retracted into the bending sheath first and then readjusted. In the process of retracting the implant, the first auxiliary part abuts against the inner wall of the bending sheath, so that there is a gap between the tube body of the bending sheath and the implant and the inner wall of the guide sheath, avoiding interference between the guide sheath, the bending sheath and the implant, so that the bending sheath and the implant can be smoothly retracted, which is convenient for adjusting and aligning the treatment site.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular, relates to a delivery catheter assembly and a transcatheter valve repair system. Background Art

[0002] Diseases in the heart, such as the mitral or tricuspid valve, generally require surgical intervention to restore or improve the structure and function of the heart. In order to reduce surgical damage, transcatheter interventional valve therapy has gradually become the first choice.

[0003] Existing interventional valve therapy requires the use of a delivery tube to enter the corresponding part of the heart along the blood vessels, and align the implant with this part to clamp the valve leaflets, cut the valve, implant the artificial valve, etc. The implant is delivered through a flexible sheath, and the sheath undergoes multiple bending processes to reach the predetermined treatment site. Therefore, after the implant is extended from the delivery tube, it is difficult for the sheath to maintain a centered position in the delivery tube. However, during the release and implantation of the implant, when the implant fails and cannot be unfolded normally, or the clamping position on the valve leaflet is not ideal, it is often necessary to retract the implant into the sheath, adjust the position, reposition and release it. At this time, if the delivery sheath connected to the implant is offset, it may cause the end of the implant to hit the distal surface of the delivery sheath and cannot enter the sheath. The implant can only be removed by open-chest surgery, resulting in failure of the operation and secondary damage to the patient. Summary of the invention

[0004] A main purpose of the present invention is to overcome the defect that the delivery sheath structure of the interventional treatment in the prior art cannot smoothly retract the implant, and to provide a delivery catheter assembly and a transcatheter valve repair system.

[0005] The present invention discloses a delivery catheter assembly, comprising:

[0006] Introducing sheath, and

[0007] A bending adjustment sheath, which is movably inserted into the guide sheath, and a first auxiliary component is protruded from the bending adjustment sheath near the distal end. The first auxiliary component is arranged on the outer periphery of the bending adjustment sheath and is symmetrical about the central axis of the bending adjustment sheath, and the first auxiliary component at least partially stops the distal opening of the guide sheath.

[0008] The present invention also discloses a transcatheter valve repair system, comprising a delivery catheter assembly and an implant of the above-mentioned structure, wherein the delivery catheter assembly is used to deliver the implant, the distal end of the bending adjustment sheath is detachably connected to the implant, the bending adjustment sheath is provided with a third auxiliary component, the distal end of the third auxiliary component is provided with an expandable structure, and the length of the expandable structure is from one quarter to one half of the length of the implant.

[0009] Compared with the prior art, in the delivery catheter assembly and transcatheter valve repair system of the present invention, the inner cavity of the guide sheath is used to provide a delivery channel for the bending sheath and the implant, and the bending sheath is provided with a protruding first auxiliary part, and the outer diameter of at least part of the structure of the first auxiliary part is larger than the inner diameter of the guide sheath, so that the first auxiliary part is at least partially stopped at the distal opening of the guide sheath. During the implantation process of the implant, after the implant is extended from the guide sheath, if the implant has not reached the accurate surgical site, the implant needs to be first retracted into the guide sheath, and then the extended position of the implant needs to be readjusted. At this time, under the action of the retraction force, due to the larger outer diameter of the first auxiliary component, the guide sheath will be stretched open to cause it to slightly deform and enter the guide sheath. At this time, the outer periphery of the first auxiliary component and the inner wall of the guide sheath are in a state of resistance and fit, and there is a distance between the tube body of the bending sheath and the inner wall of the guide sheath. Therefore, the implant connected to the distal end of the bending sheath also has a distance from the inner wall of the guide sheath. This distance can avoid interference between the distal end of the guide sheath and the proximal end of the implant, and ensure that the bending sheath and the implant are always located at the central axis of the guide sheath, so that the implant can be smoothly retracted into the guide sheath. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0011] In order to more clearly illustrate the embodiments of the present invention 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, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0012] Figure 1 Schematic diagram of the overall structure of the transcatheter valve repair system according to the first embodiment of the present invention.

[0013] Figure 2 This is an enlarged view of the distal end of the delivery catheter assembly according to the first embodiment of the present invention.

[0014] Figure 3 This is a schematic structural diagram of the first auxiliary component of Embodiment 1 of the present invention.

[0015] Figure 4 It is a front view of the first auxiliary component of the first embodiment of the present invention.

[0016] Figure 5 for Figure 4 Schematic diagram of the cross section of AA.

[0017] Figure 6 It is a right side view of the first auxiliary component of the first embodiment of the present invention.

[0018] Figure 7 It is a longitudinal cross-sectional view of the second auxiliary component of the second embodiment of the present invention.

[0019] Figure 8 It is a longitudinal cross-sectional view of the delivery catheter assembly according to the second embodiment of the present invention.

[0020] Fig. 9 This is a longitudinal cross-sectional view of the implant according to the second embodiment of the present invention entering the bending sheath.

[0021] Fig.10 Schematic diagram of the overall structure of the implant entering the bending adjustment sheath in the transcatheter valve repair system according to the second embodiment of the present invention.

[0022] Fig.11 It is a longitudinal cross-sectional view of the delivery catheter assembly in the loader according to the second embodiment of the present invention.

[0023] Fig.12 Schematic diagram of the structure of the third auxiliary component and the bending sheath tube of the third embodiment of the present invention

[0024] Fig.13 It is a schematic structural diagram of the third auxiliary component and the delivery catheter assembly of the third embodiment of the present invention.

[0025] Fig.14 Schematic diagram of the structure of the transcatheter valve repair system according to the third embodiment of the present invention.

[0026] Fig.15 This is a schematic structural diagram of the third auxiliary component of the third embodiment of the present invention.

[0027] Fig.16 It is a longitudinal cross-sectional view of the third auxiliary component of the third embodiment of the present invention.

[0028] Fig.17 This is a longitudinal cross-sectional view of the third auxiliary component of the third embodiment of the present invention being recovered in the bending sheath.

[0029] Fig.18 It is a longitudinal cross-sectional view of the third auxiliary component and the delivery catheter assembly after the implant is released according to the third embodiment of the present invention.

[0030] Fig.19 This is a longitudinal cross-sectional view of the third auxiliary component completely recovered into the bending sheath after the implant is released according to the third embodiment of the present invention.

[0031] Fig. 20 Schematic diagram of the valve clipping system according to Embodiment 3 of the present invention used for edge-to-edge repair leaflet fixation of a mitral valve. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] It should be understood that the directions or positional relationships indicated by “front”, “back”, “up”, “down”, “left”, “right”, “longitudinal”, “horizontal”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “head”, “tail”, etc. are based on the directions or positional relationships in the drawings, are constructed and operated in a specific direction, and are only for the convenience of describing the technical solution, and do not indicate that the device or element referred to must have a specific direction, and therefore should not be understood as a limitation on the present invention.

[0034] It should also be noted that, unless otherwise clearly specified and limited, the terms such as "installed", "connected", "connected", "fixed", "set" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral one; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, the element can be "directly" or "indirectly" located on the other element, or there may be one or more intervening elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0035] In the description of the present invention, it still needs to be explained that the proximal end refers to the end of the instrument or component close to the operator, and the distal end refers to the end of the instrument or component away from the operator; the axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction.

[0036] In order to overcome the defect that the delivery tube structure of the prior art interventional treatment cannot retract the implant, the present invention discloses a delivery catheter assembly and a transcatheter valve repair system, which can retract the implant into the delivery catheter assembly when necessary, and facilitate the adjustment of the position of the implant. The invention is described below through specific embodiments and drawings in the specification.

[0037] Embodiment 1

[0038] See also Figure 1 and Figure 2The first embodiment of the present invention discloses a delivery catheter assembly 100, comprising a guide sheath 110 and a bending sheath 120. The bending sheath 120 is movably inserted into the guide sheath 110. A first auxiliary component 121 is convexly provided near the distal end of the bending sheath 120, and the first auxiliary component 121 is arranged on the outer periphery of the bending sheath 120 and is symmetrical about the central axis of the bending sheath 120. The first auxiliary component 121 is at least partially stopped at the distal end opening of the guide sheath 110.

[0039] In the delivery catheter assembly 100 of the present invention, the inner cavity of the guide sheath 110 is used to provide a delivery channel for the bending sheath 120 and the implant 200, and the bending sheath 120 is provided with a protruding first auxiliary member 121, and the outer diameter of at least part of the structure of the first auxiliary member 121 is larger than the inner diameter of the guide sheath 110, so that the first auxiliary member 121 is at least partially stopped at the distal opening of the guide sheath 110. During the implantation process of the implant 200, after the implant 200 is extended from the guide sheath 110, if the implant 200 does not reach the accurate surgical site, the implant 200 needs to be firstly recovered to the guide sheath 110, and then the extended position of the implant 200 is readjusted. At this time, under the action of the retraction force, due to the large outer diameter of the first auxiliary component 121, the guide sheath 110 will be stretched open to make it slightly deformed and enter the guide sheath 110. At this time, the outer periphery of the first auxiliary component 121 is in a state of contact and fit with the inner wall of the guide sheath 110, and there is a gap between the tube body of the bending sheath 120 and the inner wall of the guide sheath 110. Therefore, the implant 200 connected to the distal end of the bending sheath 120 is also spaced from the inner wall of the guide sheath 110. Since the first auxiliary component 121 is symmetrical about the central axis of the bending sheath 120, this gap can avoid interference between the distal end of the guide sheath 110 and the proximal end of the implant 200, and the bending sheath 120 and the implant 200 are always located at the central axis of the guide sheath 110, so that the bending sheath 120 and the implant 200 are smoothly recovered into the guide sheath 110.

[0040] Preferably, see Figure 3-Figure 6 The first auxiliary component 121 includes a first connecting section 1211 and a first abutting section 1212. The first connecting section 1211 is connected to the bending adjustment sheath 120, and the maximum outer diameter of the first abutting section 1212 is greater than the inner diameter of the distal opening of the guide sheath 110. In this embodiment, the first connecting section 1211 is used to be connected to the bending adjustment sheath 120 and is cylindrical. The first abutting section 1212 is cylindrical, and the outer diameter of the first abutting section 1212 (i.e., the maximum outer diameter of the first auxiliary component 121) is slightly greater than the inner diameter of the guide sheath 110, thereby ensuring the concentricity of the bending adjustment sheath 120 and the guide sheath 110, which is beneficial for the implant 200 to be recovered into the guide sheath 110.

[0041] Furthermore, the first abutment section 1212 is connected to the first connection section 1211 through a first transition surface 1213, and the radial dimension of the first transition surface 1213 gradually increases from the proximal end to the distal end. The first transition surface 1213 and the first abutment section 1212 are in a stepped cylindrical structure. In the process of recovering the bending sheath 120, part of the first transition surface 1213 will contact the distal opening of the bending sheath 120, and the gradually increasing size of the first transition surface 1213 is conducive to the smooth recovery of the bending sheath 120 into the guide sheath 110, and avoids the first auxiliary component 121 from damaging the distal surface of the guide sheath 110.

[0042] Preferably, the first transition surface 1213 is a convex arc surface, a concave arc surface or a conical surface. The shape of the first transition surface 1213 is for the purpose of achieving a good transition and improving the centering performance of the bending sheath 120. In this embodiment, the first transition surface 1213 is set as a conical surface. By reasonably setting the range of the taper α, the effective length of the maximum diameter of the head end of the first auxiliary component 121 (i.e., the "first abutment section 1212") can be guaranteed, thereby ensuring the concentricity between the bending sheath 120 and the guide sheath 110. If the taper α is too small, it will cause greater resistance when the bending sheath 120 is retracted into the guide sheath 110, and it is easy to damage the distal surface of the guide sheath 110; if the taper α is too large, it will affect the effective length of the first abutment section 1212, resulting in a decrease in the concentricity between the bending sheath 120 and the guide sheath 110. Specifically, the taper angle α of the cone is set to 100-130°, more preferably 110-120°, and the length of the first abutting section 1212 is in the range of 1.3-1.0 mm.

[0043] Specifically, the outer wall or inner wall of the first connecting section 1211 is provided with a first convex strip, and the inner wall or outer wall of the bending sheath 120 is provided with a corresponding first notch; or, the outer wall or inner wall of the first connecting section 1211 is provided with a first notch, and the inner wall or outer wall of the bending sheath 120 is provided with a corresponding first convex strip. In this way, the first connecting section 1211 is connected to the bending sheath 120 through the cooperation and connection of the first convex strip and the first notch. In this embodiment, the outer wall of the first connecting section 122 is provided with a first notch 12111, and the inner wall of the bending sheath 120 is provided with a corresponding first convex strip. The first notch 12111 and the first convex strip are connected to each other by snapping, and the pull-off strength and rotational strength of the first connecting section 1211 and the bending sheath 120 can be improved. Further, glue can be poured into the first notch 12111 to fix the first auxiliary member 121 and the bending sheath 120 by gluing. Alternatively, the first connecting section 1211 and the bending adjustment sheath tube 120 are fixed by welding, that is, the bending adjustment sheath tube 120 is wrapped and partially melted to the first connecting section 1211 of the first auxiliary component 121 by high temperature, thereby fusing the front end of the bending adjustment sheath tube 120 and the first auxiliary component 121.

[0044] Preferably, the distal end of the first abutting section 1212 is provided with an arc portion 1214 to prevent scratching of the blood vessels and the inner wall of the heart. The radius of the arc portion 1214 should be minimized to avoid affecting the size of the first abutting section 1212, while ensuring that the first abutting section 1212 has an appropriate abutment area to achieve a reasonable positioning effect. Preferably, the radius of the arc portion 1214 is in the range of 0.2-0.4 mm.

[0045] Preferably, the length of the first auxiliary member 121 along the axial direction of the bending sheath 120 is in the range of 6-9 mm. It is understandable that if the length of the first auxiliary member 121 is too long, it will affect the bending radius of the bending sheath 120, thereby causing the distal end of the sheath to abut against the atrial wall, and if it is too short, the length of the first connecting section 1211 of the first auxiliary member 121 will be insufficient, thereby affecting the connection strength.

[0046] The material of the first auxiliary component 121 can be stainless steel, nickel-titanium or polymer material. In this embodiment, stainless steel with high strength and good processing performance is preferably used.

[0047] See again Figure 1 Preferably, the delivery catheter assembly 100 further includes an operating handle 130 disposed at the proximal end of the guide sheath 110 and a bending adjustment handle 140 disposed at the proximal end of the bending adjustment sheath 120. The operating handle 130 is used to adjust the curvature and axial movement of the distal end of the guide sheath 110, and the bending adjustment handle 140 is used to adjust the curvature and axial movement of the bending adjustment sheath 120. The two cooperate with each other and are operated outside the patient's body to adjust the relative position between the implant 200 and the treatment site.

[0048] See again Figure 1 The present invention also discloses a transcatheter valve repair system 1000, comprising a delivery catheter assembly 100 and an implant 200 of the above structure, wherein the delivery catheter assembly 100 is used to deliver the implant 200, and the distal end of the bending sheath 120 is detachably connected to the implant 200. Figure 12-14 The bending sheath 120 is provided with a third auxiliary component 123 , and an expandable structure 1231 is provided at the distal end of the third auxiliary component 123 . The length of the expandable structure 1231 is one quarter to one half of the length of the implant 200 .

[0049] The implant 200 is detachably arranged at the distal end of the bending sheath 120. After the implant 200 reaches the appropriate surgical site and is implanted, the implant 200 is separated from the bending sheath 120, and then the bending sheath 120 and the guide sheath 110 are withdrawn, so that the delivery catheter assembly 100 can be withdrawn from the body and the implant 200 can be left in the patient's body. The purpose of the expandable structure 1231 is to wrap the part of the implant 200 that is prone to scratches, so as to reduce the damage to the heart caused by the implant 200 during the withdrawal process. The length of the expandable structure 1231 is one-quarter to one-half of the length of the implant 200, taking into account both material saving and wrapping effects. Due to individual differences in the height, age, gender, etc. of the patient, the size of the heart is also different. In order to match the hearts of different sizes, the size of the implant 200 will also be different. The length of the expandable structure 1231 is proportional to the length of the implant 200, which is suitable for implants 200 of different sizes and types.

[0050] In one embodiment, the implant 200 is a valve clamping device. A connecting rod 210 for connecting to the valve clamping device is provided at the distal end of the bending sheath 120. The following briefly describes the mitral valve repair process using the valve clamping device: first, a passage from outside the body to inside the body is established through the cooperation of the guide sheath 110 and the guide wire; then, the proximal end of the valve clamping device is detachably connected to the connecting rod 210, thereby connecting the valve clamping device to the bending sheath 120; then, the bending sheath 120 is transported along the guide sheath 110 to the vicinity of the patient's mitral valve via a catheter. At this time, the valve clamping device and the bending sheath 120 are both housed in the guide sheath 110 and can be connected to the guide sheath 110. The guide sheaths 110 move relative to each other axially; finally, the operator clamps the anterior and posterior leaflets of the mitral valve together by remotely operating the valve clamping device. Once the leaflets of the mitral valve are aligned edge to edge, the operator can release the connection between the connecting rod 210 and the valve clamping device, thereby releasing the connection between the bending sheath 120 and the valve clamping device, and then implanting the valve clamping device into the patient's body to fix the anterior and posterior leaflets of the mitral valve together, thereby achieving "edge-to-edge repair" of the mitral valve. During the implantation of the valve clamping device, if the valve clamping device malfunctions and cannot clamp the valve leaflets or the clamping position on the valve leaflets is not ideal, the bending sheath 120 is appropriately withdrawn to make the first auxiliary component 121 abut against the distal surface of the guide sheath 110, and then the bending sheath 120 is continued to be withdrawn. At this time, the first auxiliary component 121 is gradually accommodated in the guide sheath 110 and always abuts against the inner cavity of the guide sheath 110, thereby correcting the concentricity of the bending sheath 120 and the guide sheath 110, ensuring that the withdrawal route of the valve clamping device is coaxial with the guide sheath 110, avoiding interference between the distal surface of the guide sheath 110 and the clamp arm or other components of the valve clamping device, so that the valve clamping device can be retracted into the guide sheath 110 in any direction, and then the distal position of the guide sheath 110 can be adjusted and the valve clamping device can be pushed out again, or the guide sheath 110 and the valve clamping device can be withdrawn from the body as a whole.

[0051] Embodiment 2

[0052] See also Figure 7-Figure 9 The delivery catheter assembly 100 provided in the second embodiment of the present invention has a basically identical structure to the delivery catheter assembly of the first embodiment, with the difference being that the bending sheath 120 is further provided with a second auxiliary component 122, and a clearance is formed between the outer wall of the second auxiliary component 122 and the inner wall of the guide sheath 110, and the second auxiliary component 122 and the first auxiliary component 121 are sequentially arranged from near to far.

[0053] It can be understood that when the implant 200 fails and cannot perform the surgical operation, the first auxiliary component 121 and the second auxiliary component 122 cooperate to form a two-point one-line structure, and jointly correct the concentricity of the bending sheath 120 and the guide sheath 110, further ensuring that the distal end of the bending sheath 120 and the distal end of the guide sheath 110 form a straight channel, ensuring that the withdrawal route of the implant 200 is coaxial with the guide sheath 110, thereby ensuring that the implant 200 can be recovered into the guide sheath 110 in any direction, which is more conducive to the recovery of the implant 200.

[0054] Preferably, the second auxiliary component 122 includes a second abutting section 1221, the outer diameter of the second abutting section 1221 is consistent with the inner diameter of the guide sheath 110, and the proximal end and the distal end of the second abutting section 1221 are smoothly connected to the outer wall of the bending adjustment sheath 120 through the second transition surface 1222. The outer shape structure of the second auxiliary component 122 is an irregular stepped cylindrical protrusion structure. The purpose of the second transition surface 1222 is to improve the smooth connection between the second abutting section 1221 and the tube body of the bending adjustment sheath 120, and to avoid the second abutting section 1221 and the inner wall of the guide sheath 110 from getting stuck.

[0055] Preferably, the length of the second auxiliary member 122 along the axial direction of the bending sheath 120 is 5-10 mm. The reasons for setting this length range are, firstly, to improve the concentricity between the bending sheath 120 and the guide sheath 110, which is conducive to the recovery of the implant 200 into the guide sheath 110; secondly, to avoid affecting the bending performance and bending angle of the bending sheath 120.

[0056] Preferably, the distance between the distal end of the second auxiliary member 122 and the proximal end of the first auxiliary member 121 along the axial direction of the bending sheath 120 is 16-25 mm. The reason for setting this distance range is to prevent the second auxiliary member 122 from affecting the bending radius and bending shape of the bending sheath 120. The maximum outer diameter of the second auxiliary member 122 is the same as the inner diameter of the guide sheath 110, thereby improving the concentricity of the bending sheath 120 and the guide sheath 110.

[0057] See also Fig. 9 and Fig.10 After the implant 200 such as the valve clamping device is in the closed state, the concentricity is corrected by the first auxiliary component 121 and the second auxiliary component 122 and then recovered into the guiding sheath 110.

[0058] Further, see Fig.11In other embodiments, the implant 200 (such as a valve clamping device) is usually pre-installed in a hollow loader 2000 by the manufacturer before leaving the factory. During the pre-installation process, the bending sheath 120 needs to be withdrawn until the implant 200 is gradually accommodated in the inner cavity of the loader 2000. The second auxiliary component 122 can ensure the concentricity between the bending sheath 120 and the inner cavity of the loader 2000, and assist in gradually receiving the implant 200 into the inner cavity of the loader 2000. In addition, since the outer diameter of the second auxiliary component 122 is larger than the inner diameter of the silicone valve 2100 at the proximal end of the loader 2000, it can prevent the implant 200 from being pulled out from the proximal end of the loader 2000 due to excessive withdrawal of the bending sheath 120, thereby preventing damage to the implant 200.

[0059] Embodiment 3

[0060] See also Figure 12-14 The delivery catheter assembly 100 provided in the third embodiment of the present invention has a substantially similar structure to that of the delivery catheter assembly in the first embodiment, except that the bending sheath 120 is further provided with a third auxiliary component 123, the proximal end of the third auxiliary component 123 is connected to the outer wall of the bending sheath 120, and the distal end is provided with an expandable structure 1231. The third auxiliary component 123 is sleeved outside the distal end of the bending sheath 120, and when the implant 200 needs to be withdrawn, the expandable structure 1231 can be opened and covered on the periphery of the implant 200 through relevant operations, and then, as it gradually retracts, the expandable structure 1231 is retracted under the action of the guide sheath 110, and is retracted into the guide sheath 110 together with the implant 200.

[0061] Preferably, the third auxiliary member 123 and the first auxiliary member 121 are arranged in sequence from far to near. Since the third auxiliary member 123 needs to wrap the implant 200 at the far end, the third auxiliary member 123 is arranged at the far end of the bending sheath 120, and the first auxiliary member 121 is arranged at the opposite proximal end, which will not hinder the expansion and contraction of the third auxiliary member 123.

[0062] Preferably, the third embodiment can also be combined with the structure of the second embodiment: the bending sheath 120 includes a second auxiliary member 122, a third auxiliary member 123, and the first auxiliary member 121 and the second auxiliary member 122 are sequentially arranged from far to near. The first auxiliary member 121, the second auxiliary member 122, and the third auxiliary member 123 cooperate with each other to ensure that the withdrawal route of the implant 200 is coaxial with the guide sheath 110, which is conducive to the withdrawal of the implant 200.

[0063] Preferably, see Fig.15 and Fig.16, the proximal end of the third auxiliary component 123 includes a third connecting section 1232, the inner wall or outer wall of the third connecting section 1232 is provided with a third notch, and the outer wall or inner wall of the bending sheath 120 is provided with a corresponding third convex strip; or, the inner wall or outer wall of the third connecting section 1232 is provided with a third convex strip, and the outer wall or inner wall of the bending sheath 120 is provided with a corresponding third notch. In this way, the third connecting section 1232 is connected to the bending sheath 120 through the matching connection of the third convex strip and the third notch. In this embodiment, the outer wall of the third connecting section 1232 is provided with a third notch, and the inner wall of the bending sheath 120 is provided with a corresponding third convex strip. The connection method of the third convex strip and the third notch 12321 can refer to the connection method of the aforementioned first notch 12111 and the first convex strip. The total length of the third connecting section 1232 is set to 5-6mm, which ensures the connection strength and does not affect the bending performance of the bending sheath 120.

[0064] Preferably, the diameter of the expandable structure 1231 gradually increases from the proximal end to the distal end, that is, the expandable structure 1231 is a hollow umbrella-shaped structure, the proximal end is open, and the distal end is connected to the bending sheath 120. The maximum outer diameter range of the expandable structure 1231 is 25-30 mm. The expandable structure 1231 is made of shape memory materials such as nickel-titanium alloy.

[0065] The manufacturing process of the third auxiliary part 123 is as follows: first, a plurality of nickel-titanium metal wires are woven into a tubular structure, and then placed in an umbrella-shaped molding mold, and heat-formed at a high temperature of 500-650°. Then, the tail end of the umbrella-shaped structure is fixed together with the steel sleeve 1233 by means of polymer material welding, or bonding, welding, or riveting, to obtain the third auxiliary part 123 of this embodiment.

[0066] The third auxiliary component 123 and the bending sheath tube 120 can also be fixed by welding with polymer materials, that is, high temperature is used to melt the connection between the bending sheath tube 120 and the third auxiliary component 123, so that the front end of the bending sheath tube 120 and the third auxiliary component 123 are fused together.

[0067] See also Fig.17 The implant 200 is a valve clamping device. When the valve clamping device fails and cannot clamp the valve leaflets or the clamping position is not ideal, the valve clamping device needs to be withdrawn and re-accommodated into the guide sheath 110. At this time, by withdrawing the bending sheath 120, the third auxiliary component 123 changes from an umbrella-shaped structure to a tubular structure, and the third auxiliary component 123 completely wraps the proximal end of the valve clamping device, thereby retracting the valve clamping device into the guide sheath 110.

[0068] For further information, see Fig.18 and Fig.19After the valve clamping device is released, the connecting rod 210 at the distal end of the bending sheath 120 used to connect to the valve clamping device is completely exposed. At this time, the delivery catheter assembly 100 needs to be completely withdrawn from the patient's body. During the withdrawal of the bending sheath 120, the third auxiliary component 123 can completely wrap the connecting rod 210, thereby preventing the connecting rod 210 from scratching the valve leaflets and the atrial wall, thereby improving the safety performance of the device and reducing surgical risks.

[0069] For further information, see Fig. 20 When the transcatheter valve repair system provided in this embodiment is used for edge-to-edge repair of the mitral valve, before the valve clamping device clamps the anterior leaflet and the posterior leaflet of the mitral valve, the third auxiliary component 123 can press the leaflet on the atrial side to reduce the swing amplitude of the anterior leaflet and the posterior leaflet, thereby facilitating the valve clamping device to clamp the leaflet, reducing the difficulty of implantation, and improving the success rate of the operation.

Claims

1. A delivery catheter assembly, characterized in that: include: Introducing sheath, and A bending adjustment sheath, wherein the bending adjustment sheath is movably inserted into the guide sheath, a first auxiliary part is convexly provided at the distal end of the bending adjustment sheath, the first auxiliary part is arranged on the outer periphery of the bending adjustment sheath and is symmetrical about the central axis of the bending adjustment sheath, the first auxiliary part is at least partially stopped at the distal opening of the guide sheath, the bending adjustment sheath is also provided with a second auxiliary part, the outer wall of the second auxiliary part is gap-matched with the inner wall of the guide sheath, the second auxiliary part and the first auxiliary part are arranged in sequence from near to far, and the delivery catheter assembly also includes operating handles respectively arranged at the proximal end of the guide sheath, and a bending adjustment handle arranged at the proximal end of the bending adjustment sheath.

2. The delivery catheter assembly according to claim 1, characterized in that: The first auxiliary component includes a first connecting section and a first abutting section, the first connecting section is connected to the bending adjustment sheath, and the maximum outer diameter of the first abutting section is greater than the inner diameter of the distal opening of the guide sheath.

3. The delivery catheter assembly according to claim 2, characterized in that: The first abutting section and the first connecting section are connected via a first transition surface, and a radial dimension of the first transition surface gradually increases from the proximal end to the distal end.

4. The delivery catheter assembly according to claim 3, characterized in that: The first transition surface is a convex arc surface, a concave arc surface or a conical surface.

5. The delivery catheter assembly according to claim 2, characterized in that: The outer wall or inner wall of the first connecting section is provided with a first convex strip, and the inner wall or outer wall of the bending adjustment sheath is provided with a corresponding first notch; or, The outer wall or the inner wall of the first connecting section is provided with a first notch, and the inner wall or the outer wall of the bending adjustment sheath is provided with a corresponding first convex strip.

6. The delivery catheter assembly according to claim 2, characterized in that: A circular arc portion is provided at the distal end of the first abutting section.

7. The delivery catheter assembly according to claim 1, characterized in that: The length of the first auxiliary part along the axial direction of the bending sheath is in the range of 6-9 mm.

8. The delivery catheter assembly according to claim 1, characterized in that: The second auxiliary component includes a second abutment section, the outer diameter of the second abutment section is consistent with the inner diameter of the guide sheath tube, and the proximal end and the distal end of the second abutment section are smoothly connected to the outer wall of the bending adjustment sheath tube through second transition surfaces.

9. The delivery catheter assembly according to claim 1, characterized in that: The length of the second auxiliary part along the axial direction of the bending sheath is in the range of 5-10 mm.

10. The delivery catheter assembly according to claim 1, characterized in that The distance between the distal end of the second auxiliary component and the proximal end of the first auxiliary component along the axial direction of the bending adjustment sheath is in the range of 16-25 mm.

11. The delivery catheter assembly according to claim 1, characterized in that: The bending adjustment sheath is also provided with a third auxiliary component, the proximal end of the third auxiliary component is connected to the bending adjustment sheath, and the distal end is provided with an expandable structure.

12. The delivery catheter assembly according to claim 11, characterized in that The third auxiliary component, the first auxiliary component and the second auxiliary component are arranged in sequence from far to near.

13. The delivery catheter assembly according to claim 11, characterized in that The proximal end of the third auxiliary member comprises a third connecting section, the inner wall or outer wall of the third connecting section is provided with a third notch, and the outer wall or inner wall of the bending adjustment sheath is provided with a corresponding third convex strip; or, The inner wall or outer wall of the third connecting section is provided with a third convex strip, and the outer wall or inner wall of the bending adjustment sheath is provided with a corresponding third notch.

14. The delivery catheter assembly according to claim 11, characterized in that The diameter of the expandable structure gradually increases from the proximal end to the distal end, and the expandable structure is made of shape memory material.

15. A transcatheter valve repair system, characterized in that: It comprises the delivery catheter assembly and implant as described in any one of claims 1-14, wherein the delivery catheter assembly is used to deliver the implant, the distal end of the bending adjustment sheath is detachably connected to the implant, the bending adjustment sheath is provided with a third auxiliary part, the distal end of the third auxiliary part is provided with an expandable structure, and the length of the expandable structure is one quarter to one half of the length of the implant.

16. The transcatheter valve repair system according to claim 15, characterized in that: The implant is a valve clipping device.

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