CN118356275A - Delivery assembly for a delivery system, and valve prosthesis system - Google Patents

Abstract

The invention discloses a delivery assembly of a delivery system, a delivery system and a valve prosthesis system, the delivery assembly comprising: an outer sheath; an inner sheath disposed within the outer sheath, the distal end of the inner sheath being adapted to be coupled to a valve prosthesis, the inner sheath and the outer sheath being axially movable relative to each other so that the valve prosthesis is selectively positioned within or outside the outer sheath; and the adjusting piece can be movably arranged in the outer sheath tube, the distal end of the adjusting piece is used for being matched with the valve prosthesis, the distal end of the adjusting piece is abutted to the valve prosthesis, and the anti-deflection force can be provided for the valve prosthesis. Therefore, the valve prosthesis can be conveniently conveyed, dislocation or overturning of the valve prosthesis can be prevented, and normal use of the valve prosthesis can be ensured.

Description

Delivery assembly for a delivery system, and valve prosthesis system

Technical Field

The invention relates to the technical field of medical equipment, in particular to a conveying assembly of a conveying system, the conveying system and a valve prosthesis system.

Background

Heart valve disease refers to heart disease caused by stenosis or regurgitation of the heart valve due to a variety of causes. For various reasons, natural heart valves have dysfunction, cannot control unidirectional blood flow, and have the phenomenon of blood reverse flow. Mitral regurgitation, for example, has the highest incidence in valvular disease. Mild mitral regurgitation symptoms are not obvious, but severe mitral regurgitation can lead to atrial fibrillation and even heart failure, which has serious influence on the daily life of patients. Thus, for moderate and severe mitral regurgitation, timely intervention therapy is required.

At present, the standard for treating mitral regurgitation is surgical open chest direct vision surgery, but the surgery has high risk, large wound and long postoperative recovery period, and is not suitable for high-risk surgery groups with advanced age, complications and the like. With the advancement of interventional techniques, percutaneous transcatheter mitral valve replacement has provided new options for patients who are not suitable for surgical open chest surgery and transcatheter repair surgery by percutaneously implanting valve prostheses instead of native mitral valves. The percutaneous route is: transapical, etc. The mitral valve replacement product via the interval access has small wound and short recovery period, and is expected to become a main stream product of percutaneous catheter mitral valve replacement.

But such products require the transvascular delivery of the valve prosthesis from the femoral vein to the valve annulus under Digital Subtraction Angiography (DSA) or ultrasound guidance. Compared with the traditional surgical direct-view operation, because a doctor cannot directly observe the lesion position and the instrument, the valve prosthesis cannot be accurately positioned and cannot be accurately released, and then the valve prosthesis is misplaced or overturned when or after being released. Even if the valve prosthesis is anchored by means of atrial anchoring or radial support forces, if the placement is not accurate, misalignment or eversion cannot be avoided in the case of external forces. Meanwhile, if the valve prosthesis is placed inaccurately, the valve prosthesis cannot be coaxial with the valve annulus, and obvious changes of original blood flow dynamics can be caused, so that the service life of the valve prosthesis is shortened.

Accordingly, there is a need for a delivery assembly or delivery system that prevents dislocation or tipping of a valve prosthesis to address the above-described issues.

Disclosure of Invention

The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, it is an object of the present invention to provide a delivery assembly for a delivery system that prevents dislocation or tipping of the valve prosthesis.

The invention further proposes a conveying system.

The present invention further proposes a valve prosthesis system.

A delivery assembly of a delivery system according to an embodiment of the first aspect of the present invention comprises: an outer sheath; an inner sheath disposed within the outer sheath, a distal end of the inner sheath being adapted to be coupled to a valve prosthesis, the inner sheath and the outer sheath being axially movable relative to each other so that the valve prosthesis is selectively positioned within or outside of the outer sheath; and an adjustment member movably disposed within the outer sheath, the distal end of the adjustment member for mating with the valve prosthesis, the distal end of the adjustment member abutting the valve prosthesis to provide an anti-deflection force to the valve prosthesis.

Therefore, the arrangement of the outer sheath tube and the inner sheath tube in the conveying assembly can facilitate the conveying of the valve prosthesis, and the arrangement of the adjusting piece in the conveying assembly can prevent the valve prosthesis from dislocation or overturning, so that the release coaxiality of the valve prosthesis can be ensured, and the long-term durability of the valve prosthesis is facilitated.

According to some embodiments of the invention, the distal end of the adjustment member is one of circular, spherical, drop-shaped, and ellipsoidal; or the adjusting piece is a guide wire, a metal tube or a composite braided tube; or the adjusting member includes: a first segment and a second segment, the first segment being connected to a distal end of the second segment, the first segment having a hardness that is less than a hardness of the second segment, and/or a diameter of the first segment that is less than a diameter of the second segment; or the diameter of the adjusting piece is more than or equal to 0.2mm and less than or equal to D1 and less than or equal to 6mm; or the adjusting member includes: the device comprises a main pipe body and at least two support arms, wherein the at least two support arms are rotatably arranged at the distal end of the main pipe body.

According to some embodiments of the invention, the curvature of the distal end of the adjuster is adjustable.

According to some embodiments of the invention, the adjustment member comprises: the valve prosthesis comprises a tube body and a stay wire, wherein the stay wire is arranged in the tube body in a penetrating mode, the far end of the stay wire is located outside the far end of the tube body, the far end of the stay wire is used for being sleeved or arranged on the valve prosthesis in a penetrating mode, and the stay wire is straightened to form an advancing path or a retreating path of the tube body.

According to some embodiments of the invention, the tube body is one of a polymer tube, a metal tube, and a composite braided tube; and/or the stay wire is one of a metal stay wire, a polymer stay wire, a metal woven stay wire or a polymer woven stay wire.

According to some embodiments of the invention, the delivery assembly further comprises: the conveying handle is connected with the proximal end of the outer sheath tube, a control module is arranged on the conveying handle and connected with the proximal end of the adjusting piece, and the control module can control the movement of the adjusting piece.

According to some embodiments of the invention, the inner sheath comprises: a first inner sheath disposed within the outer sheath; and the second inner sheath is arranged in the first inner sheath, the distal end of the second inner sheath is used for being connected with a valve prosthesis, and the torsion control property of the second inner sheath is lower than that of the first inner sheath.

The conveying system according to the present invention comprises: a guide assembly, the guide assembly comprising: a catheter sheath and a dilator; any one of the outer sheath and the dilator passes through the catheter sheath.

According to some embodiments of the invention, the distal end of the catheter sheath is formed of hypotubes and a polymeric material.

The valve prosthesis system according to the invention comprises: a valve prosthesis; the inner sheath tube and the outer sheath tube of the delivery system are used for delivering and releasing the valve prosthesis, and the adjusting piece of the delivery system is used for providing anti-deflection force for the valve prosthesis.

According to some embodiments of the invention, the valve prosthesis comprises: an outer bracket; the inner support is arranged on the inner side of the outer support; the connecting bracket is connected between the outer bracket and the inner bracket; the skirt edge is arranged on the outer bracket, the inner bracket and the connecting bracket, and the adjusting piece is abutted to the connecting bracket or the skirt edge.

According to some embodiments of the invention, the adjusting member has a pull wire, and the pull wire is sleeved outside the inner bracket; or the stay wire is sleeved on at least one supporting rod of the inner bracket and the outer bracket; or the stay wire passes through the connecting rod of the connecting bracket.

Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.

Drawings

The foregoing and/or additional aspects and advantages of the invention will become apparent and may be better understood from the following description of embodiments taken in conjunction with the accompanying drawings in which:

FIG. 1 is a schematic structural view of a transport assembly according to an embodiment of the present invention;

FIG. 2 is a schematic view of a portion of the transport assembly of FIG. 1;

FIG. 3 is a schematic structural view of a guide assembly according to an embodiment of the present invention;

FIG. 4 is a schematic view of the structure of a catheter sheath in a guide assembly according to an embodiment of the present invention;

FIG. 5 is a schematic view of the structure of a dilator according to an embodiment of the present invention;

FIGS. 6-12 are schematic path diagrams of a transport assembly according to an embodiment of the invention;

FIG. 13 is a schematic view of the distal end curvature of a guide assembly according to an embodiment of the present invention;

FIG. 14 is a schematic view of a delivery assembly mated with a valve prosthesis according to an embodiment of the present invention;

FIG. 15 is a schematic diagram II of a configuration of a delivery assembly mated with a valve prosthesis in accordance with an embodiment of the present invention;

FIG. 16 is a schematic view of a distal end bend of a delivery assembly according to an embodiment of the present invention;

Fig. 17 is a schematic structural view of an adjusting member according to the first embodiment of the present invention;

FIG. 18 is a partial schematic view of the adjustment member of FIG. 17;

FIG. 19 is a schematic view of the structure of an adjustment member according to a second embodiment of the present invention;

FIG. 20 is a schematic view of a third embodiment of an adjuster according to the present invention;

FIG. 21 is a second schematic structural view of an adjustment member according to a third embodiment of the present invention;

fig. 22 is a schematic structural view of an adjusting member according to a fourth embodiment of the present invention;

FIG. 23 is a schematic structural view of the fitting with a valve prosthesis according to an embodiment of the present invention;

FIGS. 24-29 are schematic structural views of a delivery assembly for adjusting the position of a valve prosthesis according to embodiments of the present invention;

fig. 30 is a schematic structural view of an adjuster according to a fifth embodiment of the present invention;

Fig. 31-35 are schematic structural views of a pull-cord and valve prosthesis connection, respectively, according to an embodiment of the present invention.

Reference numerals:

100. a transport assembly;

10. An outer sheath; 20. a primary inner sheath; 30. a second inner sheath; 40. an adjusting member; 41. a first section; 42. a second section; 43. a main pipe body; 44. a support arm; 45. a tube body; 46. a pull wire;

50. A valve prosthesis; 60. a guide assembly; 61. a catheter sheath; 62. a dilator; 63. a delivery handle; 64. a guide handle.

Detailed Description

Embodiments of the present invention will be described in detail below, with reference to the accompanying drawings, which are exemplary.

A delivery assembly 100 according to an embodiment of the present invention is described below with reference to fig. 1-35, the delivery assembly 100 being useful for delivery of a valve prosthesis 50 and adjustment of the position of the valve prosthesis 50.

As shown in fig. 1 and 2, a delivery assembly 100 according to an embodiment of the first aspect of the present invention includes: the outer sheath 10, the inner sheath and the adjusting member 40 are disposed within the outer sheath 10, the distal end of the inner sheath is adapted to be coupled to the valve prosthesis 50, and the inner sheath may be movably disposed within the outer sheath 10, for example, in the axial direction of the outer sheath 10, so that the valve prosthesis 50 may be selectively positioned within the outer sheath 10 or outside the outer sheath 10, for example, such that when the valve prosthesis 500 is placed in a targeted position, the outer sheath 10 is retracted and the valve prosthesis 50 is expanded, thereby enabling release of the valve prosthesis 50.

The adjusting member 40 may be movably disposed in the outer sheath 10 in the axial direction of the outer sheath 10, and the distal end of the adjusting member 40 is adapted to cooperate with the valve prosthesis 50, and the distal end of the adjusting member 40 abuts against the valve prosthesis 50, so that an anti-deflection force may be provided to the valve prosthesis 50.

Specifically, the distal end of the adjustment member 40 has a fulcrum for applying a force to the valve prosthesis 50, so that the adjustment member 40 can prevent the valve prosthesis 50 from tipping over by the force applied to the valve prosthesis 50 by the distal end. Preferably, the fulcrum of the force applied by the distal end of the adjusting member 40 may be one point of application, or may be a plurality of points of application. Preferably, the distal portion of the adjustment member 40 is bendable to effect a certain degree of deflection to provide force to the point of application of the valve prosthesis 50 where adjustment is desired. The valve prosthesis 50 preferably comprises: the inner support is arranged on the inner side of the outer support, the connecting support is connected between the outer support and the inner support, and the skirt is arranged on the outer support, the inner support and the connecting support. When or after release of the valve prosthesis 50, please refer to fig. 14 and 23, in order to adjust the position of the valve stent 50, the distal end of the adjusting member 40 abuts against the valve prosthesis 50, and the adjusting member 40 preferably abuts against the skirt of the connecting stent. Thus, the valve prosthesis 50 can be prevented from being misplaced and turned over under the action of external force when being released, the valve prosthesis 50 can be prevented from being accurately positioned, the accuracy of the placement position of the valve prosthesis is ensured, the release coaxiality of the valve prosthesis 50 is ensured, the normal use of the valve prosthesis 50 can be ensured, and the service life of the valve prosthesis is prolonged.

According to some embodiments of the present invention, as shown in fig. 17 and 18, the distal end of the adjustment member 40 is one of circular, spherical, drop-shaped, and ellipsoidal. The distal end of the adjustment member 40 is designed to be non-sharp and may be a gradual transition shape, which may prevent the delivery assembly 100 from damaging the leaflets, skirt or the entire valve prosthesis 50 during movement, thereby affecting the durability of the valve prosthesis 50 and may also prevent the delivery assembly 100 from snagging on the valve prosthesis 50 during withdrawal.

According to some embodiments of the invention, the adjustment member 40 is a guide wire, a metal tube or a composite braided tube. Wherein, the material of the adjusting piece 40 can be one of guide wire, metal tube and composite braided tube, so that the hardness of the material of the adjusting piece 40 is different, and the material can be selected according to actual needs. When the adjusting member 40 is preferably a metal pipe, as shown in fig. 18, the adjusting member 40 is preferably a hollow pipe with equal diameter, the diameter of the adjusting member 40 is D1, and D1 satisfies the relation: d1 is more than or equal to 0.2mm and less than or equal to 6mm. The whole of the adjusting member 40 may be a hollow metal tube with an equal diameter, for example, the adjusting member 40 is a nitinol tube, and the distal end of the adjusting member 40 has both bending performance and supporting performance. The diameter of the adjustment member 40 may range from 0.2mm to 6mm, and the diameter of the adjustment member 40 may preferably range from 0.4mm to 3mm, so that the adjustment member 40 may be facilitated to reach the target position to adjust the condition of the valve prosthesis 50.

According to some embodiments of the present invention, as shown in fig. 17 and 19, the adjustment member 40 includes: a first segment 41 and a second segment 42, the first segment 41 being connected to the distal end of the second segment 42, the first segment 41 having a hardness that is less than the hardness of the second segment 42, and/or the first segment 41 having a diameter that is less than the diameter of the second segment 42. The adjusting member 40 mainly comprises a first section 41 and a second section 42, specifically, the adjusting member 40 may be formed by splicing two sections of metal tubes with different sizes, the metal tubes may be hollow or solid, the first section 41 is connected to the distal end of the second section 42, and the connection between the first section 41 and the second section 42 may be integrally formed, or may be formed by laser welding or gluing. The first segment 41 has an actuating or distal end, and the first segment 41 is in contact with the valve prosthesis 50, preferably the first segment 41 can abut against the skirt of the connecting stent intermediate the inner stent and the outer stent in the valve prosthesis 50. The second section 42 is connected with the delivery handle 63 of the delivery assembly 100, and a control module is disposed inside the delivery handle 63 of the delivery assembly 100 and is connected with the proximal end of the adjusting member 40, so that the movement of the adjusting member 40 can be controlled, and the adjusting member 40 in the delivery assembly 100 can be controlled to apply an anti-tilting force to the valve prosthesis 50 by controlling the delivery handle 63 of the delivery assembly 100, so that the placement of the valve prosthesis 50 can be facilitated, and the occurrence of tilting can be avoided.

The distal end of the first section 41 is deformable relative to the second section 42, for example, referring to fig. 22, the distal end of the first section 41 may be bent 90 ° or 180 °, the distal end of the adjustment member 40 may be bent to adjust, so that different anatomical structures may be accommodated, and the control module may adjust the axial movement and bending deformation of the adjustment member 40. It is understood that the control module may adjust the axial movement, and bending of the adjustment member 40. The control module is configured to mechanically control the adjustment member 40, for example, the control module may be configured to connect the wire to the distal end of the adjustment member 40, and the control module may control the bending and movement of the distal end of the adjustment member 40 by controlling the length of the wire or the force applied to the wire, or may facilitate the first segment 41 of the adjustment member 40 to smoothly reach the target position by adjusting the deformation, so as to improve the efficiency of positioning the valve prosthesis 50 to the precise position.

Further, as shown in fig. 17, the length of the first section 41 is L3, and the diameters of the first section 41 are D3, L3, and D3 satisfy the relation: 30mm is less than or equal to L3 is less than or equal to 500mm,0.3mm is less than or equal to D3 is less than or equal to 6mm, wherein the value range of the length L3 of the first section 41 is 30mm to 500mm, the length L3 of the first section 41 can be preferably selected to be 50mm to 400mm, the value range of the diameter D3 of the first section 41 is 0.3mm to 6mm, the diameter D3 of the first section 41 can be preferably selected to be 0.4mm to 4mm, the diameter of the second section 42 can be greater than or equal to the diameter of the first section 41, and the conveying assembly 100 can be flexibly arranged according to an anatomical structure.

According to some embodiments of the invention, the distal end of the regulator 40 is made of a material having a hardness less than the hardness of the material of the valve prosthesis 50 against which it is abutted. In this manner, the regulator 40 is prevented from damaging the valve prosthesis 50.

According to still other embodiments of the present invention, as shown in fig. 20 and 21, the adjuster 40 includes: a main tube 43 and at least two arms 44, the at least two arms 44 being rotatably arranged at the distal end of the main tube 43. Wherein, at least two support arms 44 are connected with the main tube 43 through a hinge, at least two support arms 44 can form an included angle, the open support arms 44 in the adjusting member 40 can be preferably made of a low-hardness material, the low-hardness material is preferably lower than the hardness of the valve prosthesis 50, or a layer of soft material coated on the surface of the metal material, the soft material is not limited to silica gel, the distal end of the adjusting member 40 can be converted from a horizontal state to a state in which at least two support arms 44 form an included angle through the operation of the conveying handle 63 of the conveying assembly 100, and the open support arms 44 at the distal end of the adjusting member 40 are contacted with the support rods of the valve prosthesis 50, so that the position of the valve prosthesis 50 can be adjusted, and the valve prosthesis 50 can be effectively prevented from overturning.

According to some embodiments of the invention, as shown in fig. 22, the distal curvature of the adjustment member 40 is adjustable. Thus, for example, by adjusting the curvature of the distal end of the adjustment member 40 via the control module, the active adjustment of the curvature may facilitate the adjustment member 40 against the valve prosthesis 50 and may facilitate the adjustment of the position of the distal end of the adjustment member 40 on the valve prosthesis 50. Preferably, the distal end of the adjustment member 40 is of a relatively low durometer material, and the distal end of the adjustment member 40 has a durometer in the range of 20D to 90D, and preferably 30D to 70D. The low durometer distal end of the adjustment element 40 may better protect the valve prosthesis 50.

According to still other embodiments of the present invention, as shown in fig. 30-35, the adjuster 40 includes: the tube 45 and the stay wire 46, the stay wire 46 wears to locate in the tube 45, the distal end of the stay wire 46 is located the distal end of the tube 45 and is used for the cover to set or wear to locate on the valve prosthesis 50, the stay wire 46 of the straightening forms the forward path or the backward path of the tube 45. The adjusting member 40 may be configured in various structures, for example, the adjusting member 40 may be configured as a combination of a tube 45 and a pull wire 46, the pull wire 46 is inserted into the tube 45, the distal end of the tube 45 has both bending performance and pushing performance, the bending performance is convenient for the delivery assembly 100 to pass through the complex anatomical structure of the heart as a whole, the pushing performance is beneficial for limiting the inversion of the valve prosthesis 50, and the position of the valve prosthesis 50 may be adjusted to be coaxial with the mitral valve annulus in the heart after the inversion of the valve prosthesis 50.

According to some embodiments of the present invention, the tube body 45 is a polymer tube, a metal tube, or a composite braided tube, and the pull wire 46 is a metal pull wire, a polymer pull wire, a metal braided pull wire, or a polymer braided pull wire. The materials of the tube body 45 and the stay wire 46 can be various, and can be selected according to actual conditions, so that the selectivity is good.

Further, as shown in fig. 2, the length of the outer sheath 10 is L1, the diameter of the outer sheath 10 is D2, the length of the adjustment member 40 is L2, and the diameters of the adjustment member 40 are D1, L2, D2, and D1 satisfy the relation: L2/L1 is more than or equal to 1 and less than or equal to 1.5,0.05, D1/D2 is more than or equal to 0.5. Wherein the ratio of the length L2 of the adjusting member 40 to the length L1 of the outer sheath 10 is in the range of 1 to 1.5, i.e., the length of the adjusting member 40 is 1-1.5 times the length of the outer sheath 10, and the length of the adjusting member 40 is greater than the length of the outer sheath 10, so that the adjusting member 40 can be conveniently used to deliver the valve prosthesis 50 to a further position. The ratio of the diameter D1 of the adjusting member 40 to the diameter D2 of the outer sheath 10 is in the range of 0.05 to 0.5, i.e. the diameter of the adjusting member 40 is 0.05-0.5 times the diameter of the outer sheath 10, and the diameter of the adjusting member 40 is smaller than the diameter of the outer sheath 10, so that the adjusting member 40 can move in the outer sheath 10, thereby enabling the adjusting member 40 to act on the valve prosthesis 50 more freely and flexibly. The distal diameter of the outer sheath 10 may be set to be greater than or equal to the proximal diameter, which may protect the biomaterial of the valve prosthesis 50 from over-compression while maintaining the body portion of the delivery assembly 100 in a small size without long-term compression of the blood vessel. The adjustment member 40 is located inside the outer sheath 10 and the adjustment member 40 extends through the outer sheath 10, whereby the valve prosthesis 50 is changed from a free state to a compressed state in ice water with the aid of a loading tool, for example, which may be funnel-shaped, the radial dimension of the valve prosthesis 50 in the compressed state being substantially reduced.

According to some embodiments of the invention, the delivery assembly 100 of the delivery system further comprises: the delivery handle 63, the delivery handle 63 is connected with the proximal end of the outer sheath 10, the delivery handle 63 is provided with a control module, the control module is connected with the proximal end of the adjusting member 10, and the control module can control the movement of the adjusting member 10. When installing the valve prosthesis 50 into the delivery assembly 100, the outer sheath 10 may be moved distally while the inner sheath is moved proximally by manipulating the delivery handle 63 of the delivery assembly 100, compressing the valve prosthesis 50 into the interior of the outer sheath 10. When the adjustment member 40 is disposed intermediate the inner and outer brackets of the valve prosthesis 50, the adjustment member 40 can be positioned against the skirt of the valve prosthesis 50, thereby facilitating adjustment of the position of the valve prosthesis 50.

According to some embodiments of the invention, the inner sheath comprises: the first inner sheath 20 and the second inner sheath 30, the first inner sheath 20 is arranged in the outer sheath 10, the second inner sheath 30 is arranged in the first inner sheath 20, the distal end of the second inner sheath 30 is used for being connected with the valve prosthesis 50, the torsion control property of the second inner sheath 30 is lower than that of the first inner sheath 20, the first inner sheath 20 can improve the conveying performance of the whole inner sheath, and the second inner sheath 20 can be in good fit connection with the valve prosthesis 50. The distal end of the second inner sheath 30 is adapted to be coupled to the valve prosthesis 50, and the distal end of the second inner sheath 30 is removably coupled to the valve prosthesis 50 to facilitate withdrawal of the delivery assembly 100 from the target site. It should be understood that the distal end is the actuating end of the delivery assembly 100, i.e., the end proximal to the heart, and the proximal end is the operating end of the delivery assembly 100.

As shown in connection with fig. 1-4, a delivery system according to an embodiment of the second aspect of the present invention comprises: the guide assembly 60 and the delivery assembly 100 of the delivery system of the above-described embodiments. The guide assembly 60 includes: the catheter sheath 61 and the dilator 62, and any one of the outer sheath 10 and the dilator 62 passes through the catheter sheath 61. Wherein the guide assembly 60 further comprises: the guide handle 64 is operable to control the bending of the distal end of the catheter sheath 61 by manipulating the guide handle 64. The diameter of the dilator 62 is slightly smaller than the inner diameter of the catheter sheath 61, and the length of the dilator 62 is greater than the length of the catheter sheath 61. In the use process, the dilator 62 and the catheter sheath 61 are combined together, the femoral vein enters the blood vessel of a human body, and the dilator 62 and the catheter sheath 61 advance together, so that the catheter sheath 61 can be effectively prevented from being deformed, such as being collapsed. After the introducer assembly 60 has passed through the atrial septum, the dilator 62 is withdrawn from the internal lumen of the catheter sheath 61. The dilator 62 is extruded from plastic particles with a cavity in between along which the guidewire can advance. As shown in FIG. 5, the distal end of the dilator 62 is tapered to effectively avoid damaging the vessel during advancement. As shown in fig. 13, by manipulating the introducer handle 64, the distal ends of the catheter sheath 61 and the dilator 62 may be bent at least 90 ° so that the atria may be accessed smoothly through the atrial septum. The dilator 62 is then withdrawn from the internal lumen of the catheter sheath 61, i.e. the catheter sheath 61, the catheter sheath 61 remains in the atrium, and after the dilator 62 is withdrawn from the catheter sheath 61, the steering of the introducer handle 64 is continued so that the distal sheath end of the catheter sheath 61 may be bent at least 180 °, while pushing the catheter sheath 61 in the ventricular direction so that the distal end of the catheter sheath 61 is positioned above and coaxial with the mitral valve annulus in the heart. In this manner, the delivery system, through the guide assembly 60, can deliver the valve prosthesis 50 to a target site, and can place the valve prosthesis 50 in an accurate position. The delivery assembly 100 of the delivery system of the above-described embodiments, wherein either of the outer sheath 10 and the dilator 62 may be passed through the catheter sheath 61 for delivery and positioning of the valve prosthesis 50, provides a good fit.

Also, as shown in Figs. 6-12, there may be a variety of paths for delivery assembly 100 through the lumen of catheter sheath 61, i.e., the sheath, to the lesion site, wherein the preferred path is by operating guide handle 64 and delivery handle 63 of delivery assembly 100, pushing the distal end of catheter sheath 61 along with the distal end of delivery assembly 100 to the mitral valve annulus location in the heart, and then by operating delivery handle 63 to release valve prosthesis 50 to the lesion site. Other paths may be used, where the delivery assembly 100 is passed through the established passageway of the catheter sheath 61 to the left atrium, the guide handle 64 and the delivery handle 63 of the delivery assembly 100 are manipulated to bend the distal end of the catheter sheath 61 together with the distal end of the delivery assembly 100, the distal end of the catheter sheath 61 together with the distal end of the delivery assembly 100 is passed over the mitral valve annulus, the delivery handle 63 of the delivery assembly 100 is manipulated again, the distal end of the sheath 10 is moved in the left ventricular direction while pushing the catheter sheath 61, and finally the distal end of the delivery assembly 100 is passed to the lesion site, and the valve prosthesis 50 is released to the lesion site by manipulating the delivered handle. In this manner, the delivery assembly 100 may select different paths to reach the target location such that the delivery assembly 100 may meet the requirements of a multi-function design.

According to some embodiments of the invention, the distal end of the catheter sheath 61 is formed of hypotubes and a polymeric material. Preferably, the polymeric material is TPU (thermoplastic polyurethane elastomer). The distal end of the sheath 61 of this material may be bent to facilitate reaching a predetermined position within the heart.

An embodiment of a valve prosthesis system according to the third aspect of the invention comprises: the valve prosthesis 50 and the delivery system of the above embodiments, the inner sheath and outer sheath 10 of the delivery system being used to effect delivery and release of the valve prosthesis 50, the regulator 40 of the delivery system being used to provide a deflection-preventing force to the valve prosthesis 50.

According to some embodiments of the invention, as shown in fig. 23-29, a valve prosthesis 50 includes: the outer support, the inner support, the linking bridge and the shirt rim, the inner support is arranged on the inner side of the outer support, the linking bridge is connected between the outer support and the inner support, the shirt rim is arranged on the outer support, the inner support and the linking bridge, and the adjusting piece 40 is abutted on the linking bridge or the shirt rim.

Wherein, when the adjusting member 40 is positioned between the inner and outer stent of the valve prosthesis 50, the non-sharp portion of the distal end thereof abuts against the stitchable skirt of the valve prosthesis 50, and the adjusting member 40 can abut against the skirt during the releasing process, thereby preventing the valve prosthesis 50 from being overturned. When the outer sheath 10 of the delivery assembly 100 is withdrawn to the atrial septum, the valve prosthesis 50 is partially released, the distal end of the valve prosthesis 50 is anchored to the mitral valve annulus, at which point the position of the catheter sheath 61 is unchanged and the valve prosthesis 50 can maintain good coaxiality with the mitral valve. When the catheter sheath 61 is withdrawn, the valve prosthesis 50 is easy to turn over along with the withdrawal of the catheter sheath 61, on one hand, the hemodynamics can be changed, so that the service life of the valve prosthesis 50 is affected, and on the other hand, the left heart Fang Fangbi is damaged by the fixing rod of the valve prosthesis 50 in the process of turning over the valve prosthesis 50, so that the tissue is damaged. In severe cases, the withdrawal of the catheter sheath 61 may pull the valve prosthesis 50 away. To prevent eversion of the valve prosthesis 50 in the left atrium, the valve prosthesis 50 needs to be retrieved into the delivery assembly 100 for repositioning release. Valve prosthesis 50 may collapse in the left atrial direction during release without the adjustment member 40 undergoing a change in position relative to the delivery handle 63 of delivery assembly 100. Thus, the valve prosthesis 50, which is contracted in the left atrial direction, applies a force to the regulator 40, and at this time, the valve prosthesis 50 can be prevented from being turned over by manipulating the delivery handle 63 of the delivery assembly 100 so that the distal end of the regulator 40 is bent, thereby applying a force to the valve prosthesis 50 in the left ventricular direction. Since the regulator 40 applies a force to the valve prosthesis 50 in the left ventricular direction, the valve prosthesis 50 does not turn significantly during the withdrawal of the catheter sheath 61. If there is significant evidence of eversion of the valve prosthesis 50, the distal end of the adjustment member 40 may be adjusted by manipulating the delivery handle 63 of the delivery assembly 100 to limit eversion of the valve prosthesis 50. With the aid of the adjusting member 40, the valve prosthesis 50 is finally released, the valve prosthesis 50 being located at or above the mitral valve annulus coaxially with the mitral valve annulus, so that no significant change in hemodynamics occurs.

According to some embodiments of the present invention, the adjusting member 40 has a pull wire 46, wherein the pull wire 46 is sleeved on the outer side of the inner bracket, or the pull wire 46 is sleeved on at least one strut of the inner bracket and the outer bracket, or the pull wire 46 passes through a connecting rod connected with the bracket. There are a variety of ways in which the pull wire 46 may be mated to the valve prosthesis 50. As shown in fig. 31, for example, the distal end of the pull wire 46 is used to fit over the valve prosthesis 50, and in particular, the distal end of the pull wire 46 may be directly fit over the inner stent of the valve prosthesis 50; for another example, a coil may be provided on the valve prosthesis 50, the distal end of the pull wire 46 may be threaded through the coil, and the attachment location of the distal end of the pull wire 46 to the valve prosthesis 50 may be detachable to facilitate separation of the pull wire 46 from the valve prosthesis 50 at the end of the procedure. For another example, the distal end of the pull wire 46 may also be threaded over the valve prosthesis 50, as shown in fig. 32-34, and the pull wire 46 may be threaded through one or more stent struts of the valve prosthesis 50, or may even be looped around the stent struts. The pull wire 46 passes back around the small holes of the bracket rod, which can be round, square or shaped. As another example, as shown in fig. 35, the distal end of the pull wire 46 may also be threaded through the connecting rod between the inner and outer stents of the valve prosthesis 50, and the pull wire 46 may be threaded through the connecting rod in a top-to-bottom fashion, thus facilitating threading of the pull wire 46 through the connecting rod of the valve prosthesis 50.

A conveying method of a conveying assembly according to an embodiment of a fourth aspect of the present invention includes the steps of: the inner sheath delivers the valve prosthesis 50; the inner sheath releases the valve prosthesis 50 and the adjuster 40 is placed against the valve prosthesis 50 where it is necessary to apply force until the valve prosthesis 50 is completely secured. Wherein, the valve prosthesis 50 is pressed against the valve prosthesis 50 by the adjusting piece 40 in the releasing process or after releasing, so that the position of the valve prosthesis 50 can be effectively prevented from overturning, the releasing coaxiality of the valve prosthesis can be ensured, and the long-term durability of the valve prosthesis is facilitated.

According to some embodiments of the invention, the step of adjusting the position of the member 40 against the valve prosthesis where the force needs to be applied until the valve prosthesis has been secured comprises: one position of the adjuster 40 against the valve prosthesis 50; the adjustment member 40 is retracted back again to rest against another position to adjust the valve prosthesis 50 to the predetermined position. Wherein the adjustment member 40 can adjust the valve prosthesis 50 to a preset position a plurality of times by retraction, has the advantage of adjustability.

According to some embodiments of the invention, the step of adjusting the position of the member 40 against the valve prosthesis where the force needs to be applied until the valve prosthesis has been secured comprises: the adjustment member 40 adjusts the valve prosthesis under the force of the pull wire 46. The straightened guy wires 46 may form a forward path or a backward path for the tube 45, the delivery handle 63 of the delivery assembly 100 may adjust the member 40, may apply a force to the guy wires 46 of the member 40, the guy wires 46 may be straightened, and the tube 45 may travel on the path established by the guy wires 46 to reach the target location. Before the adjusting piece 40 is retracted, force needs to be applied to the pull wire 46, the pull wire 46 can be straightened, the pipe body 45 can be retracted on the passage established by the pull wire 46, and the pipe body 45 can be effectively prevented from bouncing to damage the tissue structure in the retraction process.

In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

In the description of the invention, a "first feature" or "second feature" may include one or more of such features. In the description of the present invention, "plurality" means two or more. In the description of the invention, a first feature "above" or "below" a second feature may include both the first and second features being in direct contact, and may also include the first and second features not being in direct contact but being in contact with each other by another feature therebetween. In the description of the invention, a first feature being "above," "over" and "on" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature.

In the description of the present specification, reference to the terms "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples.

While embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that: many changes, modifications, substitutions and variations may be made to the embodiments without departing from the spirit and principles of the invention, the scope of which is defined by the claims and their equivalents.

Claims (12)

1. A delivery assembly for a delivery system, comprising:

An outer sheath;

An inner sheath disposed within the outer sheath, a distal end of the inner sheath being adapted to be coupled to a valve prosthesis, the inner sheath and the outer sheath being axially movable relative to each other so that the valve prosthesis is selectively positioned within or outside of the outer sheath; and

The adjusting piece is movably arranged in the outer sheath tube, the distal end of the adjusting piece is used for being matched with the valve prosthesis, the distal end of the adjusting piece is abutted to the valve prosthesis, and anti-deflection force is provided for the valve prosthesis.

2. The delivery assembly of the delivery system of claim 1, wherein the distal end of the adjustment member is one of circular, spherical, drop-shaped, and ellipsoidal;

Or the adjusting piece is a guide wire, a metal tube or a composite braided tube;

Or the adjusting member includes: a first segment and a second segment, the first segment being connected to a distal end of the second segment, the first segment having a hardness that is less than a hardness of the second segment, and/or a diameter of the first segment that is less than a diameter of the second segment;

or the diameter of the adjusting piece is more than or equal to 0.2mm and less than or equal to D1 and less than or equal to 6mm;

or the adjusting member includes: the device comprises a main pipe body and at least two support arms, wherein the at least two support arms are rotatably arranged at the distal end of the main pipe body.

3. The delivery assembly of the delivery system of claim 1, wherein the curvature of the distal end of the adjuster is adjustable.

4. The delivery assembly of the delivery system of claim 1, wherein the adjustment member comprises: the valve prosthesis comprises a tube body and a stay wire, wherein the stay wire is arranged in the tube body in a penetrating mode, the far end of the stay wire is located outside the far end of the tube body, the far end of the stay wire is used for being sleeved or arranged on the valve prosthesis in a penetrating mode, and the stay wire is straightened to form an advancing path or a retreating path of the tube body.

5. The delivery assembly of the delivery system of claim 4, wherein the tube body is a polymeric tube, a metal tube, or a composite braided tube; and/or

The pull wire is a metal pull wire, a polymer pull wire, a metal braided pull wire or a polymer braided pull wire.

6. The transport assembly of the transport system of claim 1, further comprising: the conveying handle is connected with the proximal end of the outer sheath tube, a control module is arranged on the conveying handle and connected with the proximal end of the adjusting piece, and the control module can control the movement of the adjusting piece.

7. The delivery assembly of the delivery system of claim 1, wherein the inner sheath comprises:

A first inner sheath disposed within the outer sheath;

And the second inner sheath is arranged in the first inner sheath, the distal end of the second inner sheath is used for being connected with a valve prosthesis, and the torsion control property of the second inner sheath is lower than that of the first inner sheath.

8. A delivery system, comprising:

A guide assembly, the guide assembly comprising: a catheter sheath and a dilator;

The delivery assembly of any of the delivery systems of claims 1-7, any of the outer sheath and the dilator passing through the catheter sheath.

9. The delivery system of claim 8, wherein the distal end of the catheter sheath is formed of hypotubes and a polymeric material.

10. A valve prosthesis system, comprising:

A valve prosthesis;

the delivery system of any of claims 8-9, an inner sheath and an outer sheath of the delivery system for effecting delivery and release of the valve prosthesis, an adjustment of the delivery system for providing an anti-deflection force to the valve prosthesis.

11. The valve prosthesis system of claim 10, wherein the valve prosthesis comprises:

An outer bracket;

the inner support is arranged on the inner side of the outer support;

The connecting bracket is connected between the outer bracket and the inner bracket;

the skirt edge is arranged on the outer bracket, the inner bracket and the connecting bracket, and the adjusting piece is abutted to the connecting bracket or the skirt edge.

12. The valve prosthesis system of claim 10, wherein the adjustment member has a pull wire that is sleeved outside of the inner stent; or (b)

The stay wire is sleeved on at least one supporting rod of the inner bracket and the outer bracket; or (b)

The stay wire passes through the connecting rod of the connecting bracket.