CN215130894U - Delivery catheter assembly and transcatheter valve repair system - Google Patents

Abstract

The utility model provides a delivery catheter subassembly and through pipe valve repair system. The conveying catheter assembly comprises a guiding sheath and a bending sheath, wherein the bending sheath movably penetrates through the guiding sheath, a first auxiliary part is convexly arranged at the position, close to the far end, of the bending sheath, and at least part of the first auxiliary part is stopped at the far end opening of the guiding sheath. The utility model discloses a carry catheter subassembly, be equipped with convex first auxiliary member in transfer curved sheath pipe distal end, the distal end opening in guide sheath pipe is stopped to first auxiliary member at least part, when the treatment, if the implant does not reach accurate operation position, can make the implant withdraw earlier and transfer curved sheath pipe readjust the position again, at the in-process of withdrawing the implant, first auxiliary member and transfer curved sheath intraductal wall butt, there is the interval in the body that makes to transfer curved sheath pipe and implant and the inner wall that guides the sheath pipe, avoid guiding sheath pipe and transfer curved sheath pipe and implant to take place to interfere, make to transfer curved sheath pipe and implant to withdraw smoothly, be convenient for adjust and aim at the treatment position.

Description

Delivery catheter assembly and transcatheter valve repair system

Technical Field

The utility model belongs to the technical field of medical instrument, particularly, relate to a carry pipe subassembly and transcatheter valve repair system.

Background

Heart conditions, such as mitral or tricuspid valve disease, typically require surgical intervention to restore or improve the structure and function of the heart. Transcatheter interventional valve therapy is becoming increasingly preferred to reduce surgical trauma.

The existing interventional valve treatment needs to enter a corresponding part of a heart along a blood vessel by means of a conveying pipe, and the implant is aligned to the part to perform operations of clamping valve leaflets, cutting valves, implanting artificial valves and the like. The implant is delivered through a flexible sheath and the sheath is passed through multiple bending procedures to reach the intended treatment site, so that it is difficult to maintain the sheath in a centered position within the delivery tube after the implant has been extended from the delivery tube. However, during the release and implantation of the implant, when the implant fails to deploy normally or the clamping position on the valve leaflet is not ideal, the implant often needs to be retracted into the sheath, adjusted, repositioned and released, and at this time, if the delivery sheath connected to the implant is displaced, the end of the implant may abut against the distal end surface of the delivery sheath, and cannot enter the sheath, and only the thoracotomy operation can be performed to remove the implant, resulting in the failure of the operation and secondary damage to the patient.

SUMMERY OF THE UTILITY MODEL

A main object of the present invention is to overcome the above-mentioned prior art's defect that the delivery sheath tubular structure of the interventional therapy can't withdraw the implant smoothly, and to provide a delivery catheter assembly and a transcatheter valve repair system.

The utility model discloses a delivery catheter subassembly, include:

a guide sheath, and,

transfer curved sheath pipe, transfer curved sheath pipe movably and wear to locate in the guide sheath pipe, transfer curved sheath pipe and be close to the protruding first auxiliary member that is equipped with in the distal end portion, first auxiliary member is located transfer curved sheath pipe periphery and about transfer curved sheath pipe's central axis symmetry, first auxiliary member at least part backstop in the distal end opening of guide sheath pipe, first auxiliary member adopts stainless steel material to make.

The utility model discloses still disclose a through pipe valve repair system, delivery catheter subassembly and implant including above-mentioned structure, delivery catheter subassembly is used for carrying the implant, transfer the distal end of bent sheath pipe with can dismantle the connection between the implant, transfer the bent sheath pipe and be equipped with the third auxiliary member, the distal end of third auxiliary member is equipped with expandable structure, expandable structure's length does the quarter to the half of the length of implant.

Compared with the prior art, the utility model discloses a carry catheter subassembly and through pipe valve repair system, the inner chamber of guide sheath pipe is used for providing transfer passage for transferring curved sheath pipe and implant, and transfers curved sheath pipe to be equipped with convex first auxiliary member, and the external diameter size of the at least partial structure of first auxiliary member is greater than the internal diameter of guide sheath pipe for the distal end opening of first auxiliary member at least part backstop in guide sheath pipe. In the implantation process of the implant, after the implant extends out of the guiding sheath, if the implant does not reach the accurate surgical site, the implant needs to be firstly recycled to the guiding sheath, then the extending position of the implant needs to be adjusted again, and at the moment, under the action of withdrawal force, because the first auxiliary member has a larger outer diameter, the guiding sheath tube is expanded to be slightly deformed and enter the guiding sheath tube, and the periphery of the first auxiliary member is in a contact fit state with the inner wall of the guiding sheath tube, the distance exists between the tube body of the bending sheath tube and the inner wall of the guiding sheath tube, therefore, the implant connected with the far end of the bending sheath tube also has the distance with the inner wall of the guiding sheath tube, the distance can avoid the far end of the guiding sheath tube from interfering with the near end of the implant, and the bending adjusting sheath tube and the implant are always positioned at the central shaft of the guiding sheath tube, so that the implant is smoothly recovered into the guiding sheath tube.

Drawings

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.

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive labor.

Fig. 1 is a schematic view of the overall structure of a transcatheter valve repair system according to a first embodiment of the present invention.

Fig. 2 is an enlarged view of the distal end of a delivery catheter assembly according to a first embodiment of the present invention.

Fig. 3 is a schematic structural diagram of a first auxiliary member according to a first embodiment of the present invention.

Fig. 4 is a front view of a first auxiliary member according to a first embodiment of the present invention.

Fig. 5 is a schematic cross-sectional view a-a of fig. 4.

Fig. 6 is a right side view of the first auxiliary member according to the first embodiment of the present invention.

Fig. 7 is a longitudinal sectional view of a second auxiliary member according to a second embodiment of the present invention.

Fig. 8 is a longitudinal sectional view of a delivery catheter assembly according to a second embodiment of the present invention.

Fig. 9 is a longitudinal sectional view of the implant according to the second embodiment of the present invention entering into the bending sheath.

Fig. 10 is a schematic view of the entire structure of the curved sheath tube entering the implant in the transcatheter valve repair system according to the second embodiment of the present invention.

Fig. 11 is a longitudinal sectional view of a second delivery catheter assembly of an embodiment of the present invention in a cartridge.

Fig. 12 is a schematic structural view of a third auxiliary member and a bending sheath according to a third embodiment of the present invention

Fig. 13 is a schematic structural view of a third auxiliary member and a delivery catheter assembly according to a third embodiment of the present invention.

Fig. 14 is a schematic structural view of a transcatheter valve repair system according to a third embodiment of the present invention.

Fig. 15 is a schematic structural view of a third auxiliary member according to a third embodiment of the present invention.

Fig. 16 is a longitudinal sectional view of a third auxiliary member according to a third embodiment of the present invention.

Fig. 17 is a longitudinal sectional view of the third auxiliary member of the third embodiment of the present invention being recovered in the bending adjustment sheath.

Fig. 18 is a longitudinal cross-sectional view of a third auxiliary element and a delivery catheter assembly after release of an implant according to a third embodiment of the present invention.

Fig. 19 is a longitudinal sectional view of the third auxiliary member fully retracted into the bending sheath after the implant according to the third embodiment of the present invention is released.

Fig. 20 is a schematic view of a valve clamping system for mitral valve edge-to-edge repair leaflet fixation according to an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all embodiments of the present invention. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative efforts belong to the protection scope of the present invention.

It should be understood that the terms "front", "back", "upper", "lower", "left", "right", "longitudinal", "lateral", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", and the like, are used for describing the orientation or positional relationship of the drawings, and are constructed and operated in a specific orientation, and are used only for convenience of describing the present invention, but not for indicating that the referred device or element must have a specific orientation, and thus, should not be construed as limiting the present invention.

It is also noted that, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," "disposed," and the like are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally formed; either directly or indirectly through intervening media, either internally or in any other relationship. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or intervening elements may also be present. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art.

In the description of the present invention, it should be noted 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 far from the operator; axial refers to a direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, radial refers to a direction perpendicular to the axial direction, and circumferential refers to a direction around the axial direction.

In order to overcome the defect that the delivery tube structure of medium income formula treatment in the prior art can't withdraw the implant, the utility model discloses a delivery catheter subassembly and through pipe valve repair system can withdraw the implant in the delivery catheter subassembly when needs, conveniently adjusts the position of implant. The invention is explained below with reference to specific embodiments and the accompanying drawings.

Example one

Referring to fig. 1 and 2, a delivery catheter assembly 100 according to one embodiment of the present invention includes a guiding sheath 110 and a bending sheath 120. The bending sheath 120 is movably inserted into the guiding sheath 110. The first auxiliary member 121 is convexly disposed at the proximal end of the bending sheath 120, the first auxiliary member 121 is disposed at the outer circumference of the bending sheath 120 and is symmetrical with respect to the central axis of the bending sheath 120, and the first auxiliary member 121 is at least partially stopped at the distal end opening of the guiding sheath 110.

The utility model discloses a delivery catheter subassembly 100, the inner chamber of guide sheath pipe 110 are used for providing transfer passage for transferring curved sheath pipe 120 and implant 200, and transfer curved sheath pipe 120 and are equipped with convex first auxiliary member 121, and the external diameter size of the at least partial structure of first auxiliary member 121 is greater than the internal diameter of guide sheath pipe 110 for first auxiliary member 121 at least part backstop is in the distal end opening of guide sheath pipe 110. During the implantation of the implant 200, after the implant 200 is extended from the guiding sheath 110, if the implant 200 does not reach the exact surgical site, it is necessary to first retrieve the implant 200 to the guiding sheath 110 and then readjust the extended position of the implant 200. At this time, under the action of the withdrawing force, since the first auxiliary member 121 has a larger outer diameter, the guiding sheath 110 is expanded to be slightly deformed and enter the guiding sheath 110, and at this time, the outer circumference of the first auxiliary member 121 is in a contact and fitting state with the inner wall of the guiding sheath 110, and there is a gap between the body of the bending adjusting sheath 120 and the inner wall of the guiding sheath 110, so that the implant 200 connected to the distal end of the bending adjusting sheath 120 is also spaced from the inner wall of the guiding sheath 110. Since the first auxiliary member 121 is symmetrical with respect to the central axis of the bending sheath 120, the distance can prevent the interference between the distal end of the guiding 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 guiding sheath 110, so that the bending sheath 120 and the implant 200 can be smoothly recovered to the guiding sheath 110.

Preferably, referring to fig. 3-6, the first auxiliary member 121 includes a first connection section 1211 and a first abutting section 1212, the first connection section 1211 is connected with the bending sheath 120, and the maximum outer diameter of the first abutting section 1212 is larger than the inner diameter at the distal end opening of the guiding sheath 110. In this embodiment, the first connection section 1211 is used to connect to the bending sheath 120 and has a cylindrical shape. 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 member 121) is slightly larger than the inner diameter of the guiding sheath 110, so as to ensure the concentricity of the bending sheath 120 and the guiding sheath 110, thereby facilitating the implant 200 to be retracted into the guiding sheath 110.

Further, the first abutting section 1212 and the first connecting section 1211 are connected by 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 of stepped cylindrical configuration. In the process of recycling the bending sheath 120, the first transition surface 1213 contacts the distal opening of the bending sheath 120, and the size of the first transition surface 1213 increases gradually, which facilitates the smooth recycling of the bending sheath 120 into the guiding sheath 110 and prevents the first auxiliary member 121 from damaging the distal surface of the guiding sheath 110.

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 designed to achieve a good transition and improve the centering performance of the bending adjustment sheath 120, and the first transition surface 1213 is set as a conical surface in this embodiment, so that by reasonably setting the range of the taper α, the effective length of the maximum diameter (i.e., "the first abutting section 1212") at the head end of the first auxiliary member 121 can be ensured, thereby ensuring the concentricity between the bending adjustment sheath 120 and the guiding sheath 110. Too small a taper α causes a large resistance when the bending sheath 120 is retracted into the guiding sheath 110, and easily damages the distal end surface of the guiding sheath 110; an excessive taper α affects the effective length of the first abutting section 1212, resulting in a reduced concentricity of the bending sheath 120 and the guiding sheath 110. Specifically, the taper α of the taper is set to 100-.

Specifically, the outer wall or the inner wall of the first connection section 1211 is provided with a first protruding strip, and the inner wall or the outer wall of the bending adjusting sheath tube 120 is provided with a corresponding first notch; alternatively, the outer wall or the inner wall of the first connecting section 1211 is provided with a first notch, and the inner wall or the outer wall of the bending adjusting sheath 120 is provided with a corresponding first protruding strip. Thus, the first connection section 1211 is connected to the bending sheath 120 by the fitting connection of the first protrusion 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 adjusting sheath 120 is provided with a corresponding first protruding strip. The first notch 12111 and the first protruding strip are connected by clipping to connect the first auxiliary member 121 and the bending sheath 120, and the pulling strength and the screwing strength of the first connecting section 1211 and the bending sheath 120 can be improved. Further, glue may be injected into the first notch 12111 to fix the first auxiliary member 121 and the bending adjustment sheath 120 by gluing. Alternatively, the first connection section 1211 and the bending sheath 120 are fixed by fusion, that is, the bending sheath 120 is wrapped by the first connection section 1211 of the first auxiliary member 121 and partially melted by high temperature, thereby fusing the front end of the bending sheath 120 and the first auxiliary member 121.

Preferably, the distal end of the first abutting section 1212 is provided with a circular arc portion 1214 to prevent scratching the inner wall of the blood vessel and the heart. The radius of the arc portion 1214 should be reduced as much as possible to avoid influencing the size of the first abutting section 1212, and meanwhile, it is ensured that the first abutting section 1212 has a proper abutting area, and a reasonable positioning effect is achieved. Preferably, the radius of the arc portion 1214 is in the range of 0.2-0.4 mm.

Preferably, the length of the first auxiliary member 121 along the axial direction of the bending sheath 120 ranges from 6 to 9 mm. It can be understood that too long of the first auxiliary element 121 affects the bending radius of the bending sheath 120, and the distal end of the sheath abuts against the chamber wall, and too short of the first auxiliary element 121 results in insufficient length of the first connection section 1211, and thus the connection strength is affected.

The first auxiliary member 121 can be made of stainless steel, nitinol or polymer, and the embodiment preferably uses stainless steel with high strength and good processability.

Referring again to fig. 1, the delivery catheter assembly 100 preferably further comprises an operating handle 130 disposed at the proximal end of the guiding sheath 110 and a bending handle 140 disposed at the proximal end of the bending sheath 120. The manipulation handle 130 is used to adjust the bending and axial movement of the distal portion of the guiding sheath 110, and the bending adjustment handle 140 is used to adjust the bending and axial movement of the bending adjustment sheath 120, which cooperate to manipulate outside the patient's body to adjust the relative position between the implant 200 and the treatment site.

Referring again to fig. 1, the present invention further discloses a transcatheter valve repair system 1000, which comprises the delivery catheter assembly 100 and the implant 200, wherein the delivery catheter assembly 100 is used for delivering the implant 200, and the distal end of the bending sheath 120 is detachably connected to the implant 200. Referring to fig. 12-14, the bending sheath 120 is provided with a third auxiliary member 123, and the distal end of the third auxiliary member 123 is provided with an expandable structure 1231, and the length of the expandable structure 1231 is one-fourth to one-half of the length of the implant 200.

The implant 200 is detachably disposed at the distal end of the bending sheath 120, and after the implant 200 reaches the proper surgical site and is implanted, the implant 200 is separated from the bending sheath 120, and then the bending sheath 120 and the guiding sheath 110 are retracted, so that the delivery catheter assembly 100 can be withdrawn from the body, and the implant 200 can be left in the patient. The expandable structure 1231 is intended to wrap the portion of the implant 200 that is prone to scratch, so as to reduce damage to the heart caused by the implant 200 during the retraction process, and the length of the expandable structure 1231 is one fourth to one half of the length of the implant 200, which is both material saving and wrapping effect. The size of the heart may vary depending on individual differences in size, age, sex, etc. of the patient, and the size of the implant 200 may vary to accommodate different sized hearts, with the length of the expandable structure 1231 being set in proportion to the length of the implant 200, accommodating different sizes and types of implants 200.

In one embodiment, implant 200 is a valve clamping device. The distal end of the bending sheath 120 is provided with a connecting rod 210 for connecting with a valve clamping device. The mitral valve repair process is briefly described below with a valve clamping device: firstly, a channel from the outside to the inside of the body is established by the matching of the guide sheath 110 and the guide wire; the proximal end of the valve clamping device is then removably attached to the attachment bar 210, thereby attaching the valve clamping device to the curved sheath 120; then, the bending sheath 120 is delivered to the vicinity of the mitral valve of the patient along the guiding sheath 110 in a catheter manner, and at this time, the valve clamping device and the bending sheath 120 are both accommodated in the guiding sheath 110 and can move relative to the guiding sheath 110 in the axial direction; finally, the operator clamps the anterior leaflet and the posterior leaflet 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 adjusting bent sheath 120 and the valve clamping device, and then implanting the valve clamping device in a patient, fixing the anterior leaflet and the posterior leaflet of the mitral valve together, and realizing the edge to edge repair of the mitral valve. During the implantation process of the valve clamping device, if the valve clamping device fails to clamp the valve leaflets or the clamping position on the valve leaflets is not ideal, the bending sheath 120 is properly retracted to make the first auxiliary member 121 abut against the distal end face of the guiding sheath 110, then, the bending sheath 120 is further retracted, and the first auxiliary member 121 is gradually received in the guiding sheath 110 and is always abutted against the inner cavity of the guiding sheath 110, thereby correcting the concentricity of the bending sheath tube 120 and the guiding sheath tube 110, ensuring that the withdrawing route of the valve clamping device is coaxial with the guiding sheath tube 110, avoiding the interference between the distal end surface of the guiding sheath tube 110 and the forceps arms or other parts of the valve clamping device, so that the valve clamping device can be retracted into the guiding sheath 110 in any direction, and then the distal end position of the guiding sheath 110 can be adjusted and the valve clamping device can be pushed out again or the guiding sheath 110 and the valve clamping device can be integrally withdrawn out of the body.

Example two

Referring to fig. 7 to 9, a delivery catheter assembly 100 according to a second embodiment of the present invention is substantially the same as the delivery catheter assembly according to the first embodiment, except that: the bending sheath 120 is further provided with a second auxiliary member 122, an outer wall of the second auxiliary member 122 is in clearance fit with an inner wall of the guiding sheath 110, and the second auxiliary member 122 and the first auxiliary member 121 are sequentially arranged from near to far.

It can be understood that, when the implant 200 fails and cannot be operated, the first auxiliary element 121 and the second auxiliary element 122 cooperate to form a two-point one-line structure, which jointly corrects the concentricity of the bending sheath 120 and the guiding sheath 110, further ensures that the distal end of the bending sheath 120 and the distal end of the guiding sheath 110 form a linear channel, and ensures that the retraction path of the implant 200 is coaxial with the guiding sheath 110, thereby ensuring that the implant 200 can be retracted into the guiding sheath 110 in any direction, and further facilitating the retraction of the implant 200.

Preferably, the second auxiliary member 122 includes a second abutting section 1221, an outer diameter of the second abutting section 1221 is identical to an inner diameter of the guiding sheath 110, and a proximal end and a distal end of the second abutting section 1221 are respectively and smoothly connected with an outer wall of the bending adjusting sheath 120 through a second transition surface 1222. The second auxiliary member 122 has 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 body portion of the bending sheath 120, and avoid the second abutting section 1221 from being stuck to the inner wall of the guiding sheath 110.

Preferably, the second auxiliary member 122 has a length in the axial direction of the bending sheath 120 in the range of 5-10 mm. One reason for this length range is to improve the concentricity of the bending sheath 120 and the guiding sheath 110, which is beneficial for the implant 200 to be retracted into the guiding sheath 110; secondly, the bending performance and the bending angle of the bending sheath tube 120 are not affected.

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 in the range of 16-25 mm. The reason for this distance range is to avoid the second auxiliary 122 from affecting the bending radius and the bending shape of the bending adjustment sheath 120. The maximum outer diameter of the second auxiliary member 122 is the same as the inner diameter of the guiding sheath 110, thereby improving the concentricity of the bending sheath 120 and the guiding sheath 110.

Referring to fig. 9 and 10, the implant 200, such as a valve clamping device, is retracted into the guiding sheath 110 after correcting concentricity by the first auxiliary member 121 and the second auxiliary member 122 in the closed state.

Further, referring to fig. 11, in other embodiments, the implant 200 (e.g., a valve clamping device) is shipped pre-loaded in the hollow loader 2000 by the manufacturer, during pre-loading, the curved sheath 120 needs to be withdrawn until the implant 200 is gradually received in the inner cavity of the loader 2000, the second auxiliary element 122 can ensure concentricity between the curved sheath 120 and the inner cavity of the loader 2000, assist in gradually retracting the implant 200 into the inner cavity of the loader 2000, and prevent the implant 200 from being pulled out from the proximal end of the loader 2000 due to excessive withdrawal of the curved sheath 120, and prevent damage to the implant 200, because the outer diameter of the second auxiliary element 122 is larger than the inner diameter of the silicone valve 2100 at the proximal end of the loader 2000.

EXAMPLE III

Referring to fig. 12 to 14, a third embodiment of the present invention provides a delivery catheter assembly 100 having substantially the same structure as the first embodiment, except that: the bending sheath 120 is further provided with a third auxiliary member 123, a proximal end of the third auxiliary member 123 is connected to the outer wall of the bending sheath 120, and a distal end is provided with an expandable structure 1231. The third auxiliary member 123 is disposed at the distal end of the bending sheath 120, and when the implant 200 needs to be retracted, the expandable structure 1231 can be expanded and cover the outer circumference of the implant 200 through related operations, and then along with the gradual retraction, the expandable structure 1231 is closed under the action of the guiding sheath 110, and is retracted to the guiding sheath 110 together with the implant 200.

Preferably, the third auxiliary member 123 and the first auxiliary member 121 are disposed in order from the far side to the near side. Since the third auxiliary element 123 is required to wrap the implant 200 at the distal end, the third auxiliary element 123 is disposed at the distal end of the bending sheath 120 and the first auxiliary element 121 is disposed at the opposite proximal end without interfering with the expansion and contraction of the third auxiliary element 123.

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, and a third auxiliary member 123, the first auxiliary member 121, and the second auxiliary member 122 are sequentially disposed from far to near. The first auxiliary element 121, the second auxiliary element 122 and the third auxiliary element 123 cooperate together to ensure that the retraction path of the implant 200 is coaxial with the guiding sheath 110, which facilitates the retraction of the implant 200.

Preferably, referring to fig. 15 and 16, the proximal end of the third auxiliary element 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 the outer wall of the third connecting section 1232 is provided with a third convex strip, and the outer wall or the inner wall of the bending-adjusting sheath tube 120 is provided with a corresponding third notch. Thus, the third connecting section 1232 is connected to the bending sheath 120 through the matching connection between the third protruding 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-adjusting sheath 120 is provided with a corresponding third convex strip. Reference is made to the connection between the third rib and the third notch 12321 with respect to the connection between the first notch 12111 and the first rib. The total length of the third connecting section 1232 is set to 5-6mm, which ensures the connecting strength and does not affect the bending performance of the bending sheath tube 120.

Preferably, the diameter of the expandable structure 1231 gradually increases from the proximal end to the distal end, i.e., the expandable structure 1231 is a hollow umbrella-shaped structure with the proximal end open and the distal end connected to the bending sheath 120. The maximum outer diameter of the expandable structure 1231 ranges from 25 to 30 mm. The expandable structure 1231 is made of a shape memory material such as nitinol.

The third auxiliary member 123 is manufactured as follows: a plurality of nickel-titanium metal wires are woven into a cylindrical structure, then the cylindrical structure is placed into an umbrella-shaped shaping mold, high-temperature heat shaping is carried out at the temperature of 650 ℃, and then the tail end of the umbrella-shaped structure and the steel sleeve 1233 are fixed together in a high polymer material welding mode or a bonding, welding and riveting mode, so that the third auxiliary member 123 of the embodiment can be obtained.

The third auxiliary member 123 and the bending adjustment sheath tube 120 can be fixed by fusing a polymer material, that is, the junction between the bending adjustment sheath tube 120 and the third auxiliary member 123 is melted by using high temperature, so that the front end of the bending adjustment sheath tube 120 and the third auxiliary member 123 are fused together.

Referring to fig. 17, the implant 200 is a valve clamping device, and when the valve clamping device fails to clamp the valve leaflets or the clamping position is not ideal, the valve clamping device needs to be retracted to be accommodated in the guiding sheath 110 again, and at this time, the third auxiliary member 123 changes from an umbrella-shaped structure to a cylindrical structure by retracting the guiding sheath 120, and the third auxiliary member 123 completely wraps the proximal end of the valve clamping device, so that the valve clamping device is retracted into the guiding sheath 110.

Further, referring to fig. 18 and 19, after the valve clamping device is released, the distal end of the bending sheath 120 for connecting the connecting rod 210 with the valve clamping device is completely exposed, and at this time, the delivery catheter assembly 100 needs to be completely withdrawn from the patient, and during the process of withdrawing the bending sheath 120, the third auxiliary element 123 can completely wrap the connecting rod 210, so as to prevent the connecting rod 210 from scratching the valve leaflets and the atrial wall, improve the safety performance of the apparatus, and reduce the risk of the operation.

Further, referring to fig. 20, when the transcatheter valve repair system provided by the embodiment is used for mitral valve edge-to-edge repair, before the valve clamping device clamps the anterior leaflet and the posterior leaflet of the mitral valve, the third auxiliary element 123 can press the leaflets at the atrial side, so as to reduce the swing amplitude of the anterior leaflet and the posterior leaflet, thereby facilitating the valve clamping device to clamp the leaflets, reducing the implantation difficulty, and improving the success rate of the operation.

Claims (18)

1. A delivery catheter assembly, comprising:

a guide sheath, and,

transfer curved sheath pipe, transfer curved sheath pipe movably and wear to locate in the guide sheath pipe, transfer curved sheath pipe and be close to the protruding first auxiliary member that is equipped with in the distal end portion, first auxiliary member is located transfer curved sheath pipe periphery and about transfer curved sheath pipe's central axis symmetry, first auxiliary member at least part backstop in the distal end opening of guide sheath pipe, first auxiliary member adopts stainless steel material to make.

2. The delivery catheter assembly of claim 1, wherein the first auxiliary element comprises a first connecting section and a first abutting section, the first connecting section being connected with the bend adjusting sheath, the first abutting section having a maximum outer diameter larger than an inner diameter at a distal opening of the guiding sheath.

3. The delivery catheter assembly of claim 2, wherein the first abutment section and the first connecting section are connected by a first transition surface, the first transition surface increasing in radial dimension from the proximal end to the distal end.

4. The delivery catheter assembly of claim 3, wherein the first transition surface is a convex arc, a concave arc, or a tapered surface.

5. The delivery catheter assembly of claim 2, wherein the outer wall or the inner wall of the first connecting section is provided with a first rib, and the inner wall or the outer wall of the bend-adjusting sheath is provided with a corresponding first notch; alternatively, the first and second electrodes may be,

the outer wall or the inner wall of first linkage segment are equipped with first notch, the inner wall or the outer wall of transferring the curved sheath pipe are equipped with corresponding first sand grip.

6. The delivery catheter assembly of claim 2, wherein the distal end of the first abutment section is provided with a radius.

7. The delivery catheter assembly of claim 1, wherein the first auxiliary element has a length in the axial direction of the bending sheath in the range of 6-9 mm.

8. The delivery catheter assembly of claim 1, wherein the bending sheath is further provided with a second auxiliary member, an outer wall of the second auxiliary member is in clearance fit with an inner wall of the guiding sheath, and the second auxiliary member and the first auxiliary member are arranged in sequence from the proximal end to the distal end.

9. The delivery catheter assembly of claim 8, wherein the second auxiliary element comprises a second abutment section having an outer diameter corresponding to an inner diameter of the guiding sheath, and wherein proximal and distal ends of the second abutment section are respectively smoothly connected to an outer wall of the bending sheath via second transition surfaces.

10. The delivery catheter assembly of claim 8, wherein the second auxiliary element has a length in the axial direction of the bending sheath in the range of 5-10 mm.

11. The delivery catheter assembly of claim 8, wherein the distal end of the second auxiliary element and the proximal end of the first auxiliary element are spaced apart in the axial direction of the bending sheath in a range of 16-25 mm.

12. The delivery catheter assembly of claim 8, wherein the bending sheath is further provided with a third auxiliary element, the third auxiliary element being connected to the bending sheath at a proximal end thereof and provided with an expandable structure at a distal end thereof.

13. The delivery catheter assembly of claim 12, wherein the third auxiliary element, the first auxiliary element and the second auxiliary element are arranged in a distal-to-proximal order.

14. The delivery catheter assembly of claim 12, wherein the proximal end of the third auxiliary element comprises a third connecting section, wherein the inner wall or the outer wall of the third connecting section is provided with a third notch, and the outer wall or the inner wall of the bending sheath is provided with a corresponding third rib; alternatively, the first and second electrodes may be,

the inner wall or the outer wall of third linkage segment is equipped with the third sand grip, the outer wall or the inner wall of transferring the curved sheath pipe are equipped with corresponding third notch.

15. The delivery catheter assembly of claim 12, wherein the expandable structure increases in diameter from a proximal end to a distal end, the expandable structure being made of a shape memory material.

16. The delivery catheter assembly of claim 1, further comprising an operating handle disposed at the proximal end of the guiding sheath and a bending handle disposed at the proximal end of the bending sheath.

17. A transcatheter valve repair system comprising the delivery catheter assembly of any one of claims 1-16 and an implant, the delivery catheter assembly being configured to deliver the implant, the distal end of the curved sheath being removably coupled to the implant, the curved sheath being provided with a third auxiliary element, the distal end of the third auxiliary element being provided with an expandable structure having a length of one-fourth to one-half of the length of the implant.

18. The transcatheter valve repair system of claim 17, wherein the implant is a valve clamping device.

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