CN218961037U - Valve prosthesis delivery device - Google Patents

Abstract

The embodiment of the application relates to the technical field of medical devices, and provides a delivery device of a valve prosthesis, which comprises: a balloon catheter assembly, the balloon catheter assembly comprising: the device comprises a connecting pipe and a first balloon and a second balloon which are positioned on the connecting pipe, wherein the first balloon and the second balloon both comprise a filling state and a contracting state, the first balloon is positioned at the end part of the distal end of the connecting pipe, the second balloon is positioned at the distal end of the connecting pipe, the diameter of the first balloon in the filling state is smaller than that of the second balloon in the filling state, the first balloon is used for guiding the delivery of the valve prosthesis to a target position, and the second balloon is used for judging whether a delivery path passes through chordae tendineae. The valve prosthesis delivery device provided by the embodiment of the application is at least beneficial to reducing the surgical risk.

Description

Valve prosthesis delivery device

Technical Field

The embodiment of the application relates to the technical field of medical devices, in particular to a delivery device of a valve prosthesis.

Background

Mitral insufficiency (Mitral Regurgitation: MR) is the most common valve disorder, with a incidence of about 1.7% in the general population. Severe MR will severely impair cardiac function, increase the risk of heart failure, severely threatening health and longevity.

The main treatment modality for traditional severe MR patients is mitral valve repair/replacement under extracorporeal circulation, i.e. repair of the mitral valve by open chest surgery or replacement of the native mitral valve with a valve prosthesis. The mitral valve repair/replacement technology under the extracorporeal circulation is mature, the effect is definite, but the risk is high and the death rate is high for the aged, the patients with serious cardiac insufficiency or serious complications, and the treatment mode is not easy to adopt.

Transcatheter mitral valve replacement (Transcatheter Mitral Valve Replacement, TMVR) is a minimally invasive valve replacement technique emerging in recent years. The technology delivers the valve prosthesis to the target position through the paths of apex, atrial septum and the like, then releases the valve to realize the replacement of the native mitral valve, thereby avoiding the traumatic operations such as sternal cleavage, extracorporeal circulation and the like. Therefore, TMVR has low risk, less trauma and fast healing, provides treatment opportunities for replacement valves for advanced high-risk MR patients, reduces the degree of regurgitation and avoids heart failure, thereby benefiting advanced high-risk MR patients.

However, there remains a need for improvements in existing delivery devices for delivering valve prostheses to reduce the risk of surgery.

Disclosure of Invention

Embodiments of the present application provide a delivery device for valve prostheses that at least facilitates reducing surgical risk.

According to some embodiments of the present application, an aspect of an embodiment of the present application provides a delivery device for a valve prosthesis, comprising: a balloon catheter assembly, the balloon catheter assembly comprising: the device comprises a connecting pipe and a first balloon and a second balloon which are positioned on the connecting pipe, wherein the first balloon and the second balloon both comprise a filling state and a contracting state, the first balloon is positioned at the end part of the distal end of the connecting pipe, the second balloon is positioned at the distal end of the connecting pipe, the diameter of the first balloon in the filling state is smaller than that of the second balloon in the filling state, the first balloon is used for guiding the delivery of the valve prosthesis to a target position, and the second balloon is used for judging whether a delivery path passes through chordae tendineae.

In some embodiments, the second balloon is located at the end of the connecting tube distal end and encloses the first balloon, or the second balloon is axially spaced from the first balloon and is located proximal to the first balloon.

In some embodiments, the first balloon includes a distal working section and a proximal working section, both of which are tapered when the first balloon is in the inflated state.

In some embodiments, the first balloon is in an inflated state with an included angle of the profile of the distal working segment being less than an included angle of the profile of the proximal working segment.

In some embodiments, the delivery device of the valve prosthesis further comprises: a sheath assembly comprising a sheath movably sleeved over the connecting tube, the sheath being adapted to bind the valve prosthesis during delivery; the first balloon further comprises: a first primary working section and a first secondary working section positioned between the distal working section and the proximal working section, the first primary working section being positioned distally of the first secondary working section; the diameter of the first main working section is larger than or equal to the outer diameter of the sheath tube; the diameter of the first auxiliary working section is smaller than or equal to the inner diameter of the sheath.

In some embodiments, the length of the first primary working segment is greater than the length of the first secondary working segment in the direction of extension along the balloon catheter assembly.

In some embodiments, the second balloon is bulbous, drum-shaped, lantern-shaped, or shuttle-shaped in the inflated state.

In some embodiments, the connection tube includes a connection tube body and a guidewire lumen extending axially through the connection tube body for passage of a guidewire.

In some embodiments, the connecting tube comprises: the first pressurizing cavity extends along the axial direction of the connecting pipe body, the distal end of the first pressurizing cavity is communicated with the first balloon through a first main hole of the outer wall of the connecting pipe body, the proximal end of the first pressurizing cavity is communicated with the outside through a first auxiliary hole of the outer wall of the connecting pipe body, and the first pressurizing cavity is used for realizing that the first balloon is in a filling state or a contraction state; the second pressurizing cavity extends along the axial direction of the connecting pipe main body, the distal end of the second pressurizing cavity is communicated with the second saccule through a second main hole of the outer wall of the connecting pipe main body, the proximal end of the second pressurizing cavity is communicated with the outside through a second auxiliary hole of the outer wall of the connecting pipe main body, and the second pressurizing cavity is used for realizing that the second saccule is in a filling state or a shrinkage state.

In some embodiments, the balloon catheter assembly further comprises a tailstock comprising: a first branch channel located at the proximal end of the balloon catheter assembly and communicating with the first secondary bore to provide an interface for connection with a pressurizing device; a first pressurizing head communicated with the proximal end of the first branch channel; a second branch channel positioned at the proximal end of the balloon catheter assembly and communicated with the second auxiliary hole to provide an interface for connection with the pressurizing device; and the second pressurizing head is communicated with the proximal end of the second branch channel.

In some embodiments, the tailstock further comprises: and the tail seat reinforcement is positioned at the proximal end of the balloon catheter assembly, and the first branch channel and the second branch channel are both fixed through the tail seat reinforcement.

In some embodiments, the balloon catheter assembly further comprises: the connecting reinforcement is positioned at the proximal end of the balloon catheter assembly, and the tailstock and the connecting pipe are fixed through the connecting reinforcement.

In some embodiments, the connection tube includes a functional layer for enhancing the mechanical properties of the connection tube.

In some embodiments, the functional layer is a reinforcing layer disposed in the connection tube to increase the bending resistance and/or kink resistance of the connection tube, and/or the functional layer is a hydrophilic coating disposed on an outer surface of the connection tube to enhance the smoothness of the connection tube.

In some embodiments, the reinforcement layer extends from the proximal end to the distal end of the connection tube, and the reinforcement layer is positioned at the distal end of the connection tube with less resistance to bending and/or kink resistance than the reinforcement layer is positioned at the proximal end of the connection tube.

In some embodiments, the delivery device includes a plurality of visualization elements positioned at the distal end of the connecting tube, the visualization elements configured to display the position of the first balloon and the second balloon within the human body under the diagnostic device.

In some embodiments, the delivery device of the valve prosthesis further comprises an inner tube assembly comprising an inner tube and a clip, the inner tube being sleeved on the connecting tube, the clip being disposed at a distal end of the inner tube for detachable connection with the valve prosthesis; the sheath assembly comprises a sheath movably sleeved on the inner tube, and the sheath is used for constraining the valve prosthesis during delivery; the handle assembly is located at the proximal end of the delivery device and the inner tube assembly remains relatively stationary with the handle assembly.

The technical scheme provided by the embodiment of the application has at least the following advantages: in the valve prosthesis delivery device provided by the embodiment of the application, the balloon catheter assembly is provided with the first balloon and the second balloon in two different states, wherein the first balloon can be used for guiding the valve prosthesis to be delivered to the target position, and the second balloon can be used for judging whether the delivery device passes through chordae tendineae when delivering the valve prosthesis to the target position along the delivery path established by the guide wire, so that the balloon catheter assembly can have the functions of guiding and exploring simultaneously when the distal end of the delivery device enters the ventricle to the atrium through the apex of the heart. Compared with the traditional mode of adopting an additional balloon catheter to explore, after confirming that the delivery path established by the guide wire does not pass through the chordae tendineae, evacuating the balloon catheter from the heart, and then pushing the valve prosthesis to the target position along the guide wire, the delivery device provided by the embodiment of the application can reduce the risk caused by the fact that the instrument enters and exits from the apex incision for many times; in addition, the first balloon and the second balloon can be switched between a filling state and a contracting state, namely, the diameters of the first balloon and the second balloon are variable, so that when the valve prosthesis is released, the first balloon and the second balloon can be decompressed to keep the contracting state, and the balloon catheter assembly is partially retracted, thereby being more beneficial to the expansion of the valve prosthesis and simultaneously avoiding the damage of the distal end of the balloon catheter assembly to atrial tissues when the valve prosthesis is released; after the valve prosthesis is released, when the distal end of the delivery device is withdrawn from the human body, the balloon catheter assembly can be configured to be in a state when the balloon catheter assembly enters the target position, namely, the first balloon is in a full state, and the second balloon is in a contracted state, and the risk that the distal end of the delivery device directly withdraws from the tissue when leaving the apex of the heart, size mutation occurs and massive hemorrhage occurs can be avoided due to transition of the first balloon.

Drawings

One or more embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings, which are not to be construed as limiting the embodiments unless specifically indicated otherwise; in order to more clearly illustrate the embodiments of the present application or the technical solutions in the conventional technology, the drawings that are required to be used in the embodiments will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person of ordinary skill in the art.

FIG. 1 is a partial schematic view of a balloon catheter assembly and an inner tube assembly at a distal end of a delivery device according to one embodiment of the present application;

FIG. 2 is a schematic structural view of a first balloon and a second balloon according to an embodiment of the present disclosure;

FIG. 3 is a schematic view of another first balloon and a second balloon according to an embodiment of the present disclosure;

FIG. 4 is a schematic illustration of the dimensions of a first balloon and a second balloon according to an embodiment of the present application;

FIG. 5 is a schematic illustration of the dimensions of another first balloon and a second balloon provided in an embodiment of the present application;

FIG. 6 is a schematic longitudinal cross-sectional view of a balloon catheter assembly according to an embodiment of the present application;

FIG. 7 is a schematic cross-sectional view of a connecting tube according to an embodiment of the present disclosure;

FIG. 8 is a schematic view of a developer according to an embodiment of the present disclosure;

FIG. 9 is a schematic diagram of a delivery device according to an embodiment of the present disclosure;

fig. 10-13 are schematic views of various steps in a delivery of a mitral valve prosthesis by a delivery device according to another embodiment of the present application.

Detailed Description

From the background, there remains a need for improvements in existing delivery devices for delivering valve prostheses to reduce the risk of surgery.

Analysis has found that in conventional transapical mitral valve replacement procedures, an operator needs to first confirm with additional accessories whether the established delivery path is safe after establishing the delivery path through the guidewire. For example, by probing the balloon catheter over the guidewire, confirming that the guidewire has not passed through the chordae, evacuating the balloon catheter from the heart, and then pushing the mitral valve prosthesis loaded by the delivery device along the guidewire to the target location. The need for one more balloon catheter replacement by the operator during the procedure increases the risk of bleeding from the apex incision.

Furthermore, the lead of existing transapical mitral valve delivery devices is often incompressible and/or non-recyclable, is prone to touching the atrial wall during use, and limits the space for use of the delivery device.

On the other hand, the existing retractable guide head cannot be in a full state again when the distal end of the delivery device is withdrawn from the heart, so that the diameter of the instrument is suddenly changed when the delivery device is withdrawn from the apex, and the disadvantages of blood splashing, massive hemorrhage and the like are easily caused.

In response to one or more of the above-mentioned problems, in accordance with some embodiments of the present application, an embodiment of the present application provides a delivery device for a valve prosthesis that is at least beneficial for reducing the risk of surgery.

Embodiments of the present application will be described in detail below with reference to the accompanying drawings. However, as will be appreciated by those of ordinary skill in the art, in the various embodiments of the present application, numerous technical details have been set forth in order to provide a better understanding of the present application. However, the technical solutions claimed in the present application can be implemented without these technical details and with various changes and modifications based on the following embodiments.

In various embodiments of the present application, "proximal" refers to the end that is closer to the operator, farther from the patient; accordingly, "distal" refers to the end that is closer to the patient, farther from the operator.

In various embodiments of the present application, "first" and "second" are used merely to distinguish between components, members, or parts to be described, and do not explicitly or implicitly have a sequential, comparative, or other relationship between the two.

Fig. 1 is a schematic partial view of a balloon catheter assembly and an inner tube assembly provided at a distal end of a delivery device according to an embodiment of the present application, fig. 2 is a schematic structural view of a first balloon and a second balloon provided according to an embodiment of the present application, fig. 3 is a schematic structural view of another first balloon and a second balloon provided according to an embodiment of the present application, fig. 4 is a schematic dimensional view of a first balloon and a second balloon provided according to an embodiment of the present application, fig. 5 is a schematic longitudinal sectional view of another first balloon and a second balloon provided according to an embodiment of the present application, fig. 6 is a schematic sectional view of a connecting tube provided according to an embodiment of the present application; fig. 8 is a schematic structural view of a developing member according to an embodiment of the present application, and fig. 9 is a schematic structural view of a delivery device according to an embodiment of the present application.

The following describes the delivery device of the valve prosthesis according to the present embodiment in detail with reference to the accompanying drawings, which are specifically as follows:

referring to fig. 1-3, a delivery device for a valve prosthesis, comprising: balloon catheter assembly 110, balloon catheter assembly 110 comprising: the connecting tube 112 and the first balloon 111a and the second balloon 111b on the connecting tube 112, the first balloon 111a and the second balloon 111b together constitute a balloon 111 on the distal end of the connecting tube 112, the first balloon 111a and the second balloon 111b each include an inflated state and a deflated state, the first balloon 111a is on the distal end of the connecting tube 112, the second balloon 111b is on the distal end of the connecting tube 112, the diameter of the first balloon 111a in the inflated state is smaller than the diameter of the second balloon 111b in the inflated state, the first balloon 111a is for guiding the delivery of the valve prosthesis to the target site, and the second balloon 111b is for judging whether the delivery path passes through the chordae tendineae.

In this embodiment, the inflated state of the first balloon 111a and the second balloon 111b refers to a state in which the first balloon 111a and the second balloon 111b are positioned when the Pressure in the first balloon 111a and the second balloon 111b is a Nominal Pressure. The contracted states of the first balloon 111a and the second balloon 111b refer to states in which the first balloon 111a and the second balloon 111b are in when the Pressure inside the first balloon 111a and the second balloon 111b is less than a Nominal Pressure (Nominal Pressure).

For valve prostheses, the valve prostheses include a compressed state and a released state, the valve prostheses in the compressed state having at least a portion of a radial dimension that is less than the radial dimension of the valve prostheses in the released state. When the valve prosthesis is required to be delivered to a target position of a human body, the valve prosthesis is required to be set into a compressed state; after the valve prosthesis is delivered to the target position of the human body, the valve prosthesis is required to be converted into a release state from a compression state by a balloon or a self-expansion mode, so as to realize the replacement of the native valve.

In this embodiment, the delivery path is a path established by a guidewire from outside the body to inside the body, through the apex of the heart, into the ventricle to the atrium, for guiding delivery of the valve prosthesis in the delivery device.

For chordae tendineae, one end of the chordae tendineae is attached to the papillary muscle tip and the other end is attached to the ventricular face and free margin of the atrioventricular valve. Chordae tendineae and annulus fibrosus, valve and papillary muscles are functionally integral and play an important role in preventing the native valve She Xiangxin from everting and blood flowing back into the atrium. Accordingly, the valve prosthesis in this example may be a mitral valve prosthesis for mitral valve replacement; but may also be a tricuspid valve prosthesis for tricuspid valve replacement.

In the valve prosthesis delivery device provided in the embodiments of the present application, the balloon catheter assembly 110 has a first balloon 111a and a second balloon 111b with two different shapes, wherein the first balloon 111a can be used for guiding the valve prosthesis to be delivered to a target position, and the second balloon 111b can be used for judging whether the delivery device passes through chordae tendineae when delivering the valve prosthesis to the target position along a delivery path established by a guide wire, so that the balloon catheter assembly 110 can have both guiding and exploratory functions when pushing the distal end of the delivery device gradually from the apex of the heart into the ventricle to the atrium. Compared with the method adopting an additional saccule catheter for exploring, the risk caused by the fact that the instrument needs to enter and exit the apex incision for many times can be reduced; in addition, the first balloon 111a and the second balloon 111b can be inflated to a named pressure to be in an inflated state or depressurized to be in a contracted state, that is, the diameters of the first balloon 111a and the second balloon 111b are variable, so that when the valve prosthesis is released, the first balloon 111a and the second balloon 111b can be depressurized to be in a contracted state, and the balloon catheter assembly 110 is partially retracted, thereby being more beneficial to the deployment of the valve prosthesis, and simultaneously avoiding the damage of the distal end of the balloon catheter assembly 110 to atrial tissues when the valve prosthesis is released; after release of the valve prosthesis, when the distal end of the delivery device is withdrawn from the body, the balloon catheter assembly 110 may be configured to be in a state when the balloon catheter assembly 110 is brought into the target position, i.e. the first balloon is in a inflated state and the second balloon is in a deflated state, and due to the transition of the first balloon 111a, the risk of massive hemorrhage due to size mutation caused by direct withdrawal of the distal end of the delivery device from the tissue when leaving the apex of the heart may be avoided.

For the first balloon 111a and the second balloon 111b, in some embodiments, referring to fig. 2, the second balloon 111b is located at the end of the distal end of the connecting tube 112 and encases the first balloon 111a; in other embodiments, referring to fig. 3, the second balloon 111b is axially spaced from the first balloon 111a and is located proximal to the first balloon 111 a.

For convenience of description, in the drawings provided in this embodiment, the second balloon 111b is disposed at an axial distance from the first balloon 111a, and the proximal end of the first balloon 111a is disposed as an example, and the positional relationship between the first balloon 111a and the second balloon 111b is not limited, so long as the second balloon 111a is not located at the distal end of the first balloon 111a in the axial direction.

In some embodiments, referring to fig. 4 and 5, the first balloon 111a includes a distal working section and a proximal working section. When the first balloon 111a is in the inflated state, the distal working section and the proximal working section are substantially tapered. Preferably, it is cone-shaped or truncated cone-shaped; more preferably, the slope of the curve of the contour line of the first balloon 111a becomes continuously larger. In this way, the first balloon 111a can be made to reduce resistance so that the first balloon 111a can smoothly enter the heart. Preferably, the first balloon 111a, in the inflated state, has an included angle α of the profile of the distal working section smaller than an included angle β of the profile of the proximal working section. For example, when the contour line of the first balloon 111a is curved, the included angle α is the minimum value of the included angle between the normals of the two contour lines of the distal working section. The included angle beta of the profile of the proximal working section is the included angle between the profile lines of the proximal working section. When the included angle α of the profile of the distal working segment is smaller than the included angle β of the proximal working segment, axial space may be saved while reducing the resistance of the first balloon 111 a.

Further, referring to fig. 4, the first balloon 111a further includes: a first primary working segment and a first secondary working segment positioned between the distal working segment and the proximal working segment, the first primary working segment being positioned distally of the first secondary working segment. The diameter D1 of the first main working section is larger than or equal to the outer diameter of the sheath; the diameter D2 of the first auxiliary working section is smaller than or equal to the inner diameter of the sheath. The diameter D1 of the first main working section is slightly larger than the outer diameter of the sheath, and the first main working section can be abutted against the sheath for restraining the valve prosthesis during delivery, so that the sheath is prevented from moving too far away when the valve prosthesis is loaded, the first main working section and the outer wall of the sheath are prevented from generating steps, the human tissue is prevented from being damaged when the balloon catheter assembly 110 enters, and the resistance to the distal end of the delivery device entering is reduced; the diameter D2 of the first secondary working section is slightly smaller than the inner diameter of the sheath, so that the first balloon 111a can be fixed at the distal end of the sheath to achieve close fitting, and therefore the sheath assembly and the balloon catheter assembly are relatively stable. Preferably, the diameter D1 of the first main working section may be equal to the outer diameter of the sheath, and the diameter D2 of the first auxiliary working section may be equal to the inner diameter of the sheath. Namely, the difference value between the diameter D1 of the first main working section and the diameter D2 of the first auxiliary working section is equal to the wall thickness of the sheath, so that the step-shaped structure can be prevented from damaging human tissues, and the sheath assembly and the balloon catheter assembly are more stable. The sheath assembly and the sheath are described in detail below.

On the other hand, the length L1 of the first primary working segment is greater than the length L2 of the first secondary working segment in the direction of extension along the balloon catheter assembly 110. It will be appreciated that when the first balloon 111a is pressurized alone, the length L1 of the first primary working segment is greater than the length L2 of the first secondary working segment, as the length L2 of the first secondary working segment is less than the length L1 of the first primary working segment, which may save axial space.

In some embodiments, with continued reference to fig. 4, the second balloon 111b may be spherical in the inflated state. In other embodiments, the second balloon 111b may be drum-shaped, lantern-shaped, or shuttle-shaped in the inflated state.

It will be appreciated that it may be necessary to determine whether the delivery path is through the chordae tendineae by the second balloon 111 b. Thus, the second balloon 111b needs to have a larger diameter, for example, larger than the maximum diameter of the first balloon 111a, to satisfy the exploratory function of the second balloon 111 b.

The material of the first balloon 111a and the second balloon 111b is not particularly limited in this embodiment. For example, the materials of the first and second balloons 111a and 111b may employ one or more of polyolefin copolymers (Polyolefin copolymer, POC), polyurethane (PU), polyethylene (PE), nylon, and polyethylene terephthalate (PET).

In addition, the method in which the first balloon 111a and the second balloon 111b are sealed and attached to the distal end of the connection tube 112 is not particularly limited in this embodiment. For example, the first balloon 111a and the second balloon 111b may be sealed and sleeved on the distal end of the connection tube 112 by means of glue bonding, hot melt welding, laser welding, ultrasonic welding, or the like.

Referring to fig. 6, in some embodiments, the connection tube 112 includes a connection tube body 1127 and a guidewire lumen 1121 extending axially through the connection tube body 1127, the guidewire lumen 1121 for passage of a guidewire. Preferably, the guide wire lumen 1121 is provided at a central position of the connection tube body 1127. After the guidewire establishes a delivery path, the guidewire lumen 1121 is used to sheath the guidewire so that the distal end of the delivery device may be advanced into the body along the delivery path established by the guidewire and then to the targeted surgical site.

With continued reference to fig. 6, the connecting tube 112 further includes: a first pressurized chamber 1122a for effecting inflation or deflation of first balloon 111a, and a second pressurized chamber 1122b for effecting inflation or deflation of second balloon 111 b. Specifically, the first pressurizing chamber 1122a extends in the axial direction of the connection pipe body 1127, the distal end of the first pressurizing chamber 1122a communicates with the first balloon 111a through the first main hole 1123a of the outer wall of the connection pipe body 1127, and the proximal end of the first pressurizing chamber 1122a communicates with the outside through the first sub-hole 1123b of the outer wall of the connection pipe body 1127. The second pressurizing chamber 1122b extends in the axial direction of the connection tube body 1127, the distal end of the second pressurizing chamber 1122b communicates with the second balloon 111b through the second main hole 1124a of the outer wall of the connection tube body 1127, and the proximal end of the second pressurizing chamber 1122b communicates with the outside through the second sub hole 1124b of the outer wall of the connection tube body 1127.

The first and second pressure chambers 1122a and 1122b can be used to individually pressurize or depressurize the first and second balloons 111a and 111b, respectively, thereby individually controlling the first and second balloons 111a and 111 b.

Referring to fig. 7, in the present embodiment, the first and second pressurizing chambers 1122a and 1122b are symmetrically located at both sides of the guidewire chamber 1121 in the circumferential direction. The cross sections of the first and second pressurizing chambers 1122a and 1122b are each provided in a fan shape. However, the present embodiment does not limit the cross section of the first and second pressurizing chambers 1122a and 1122 b. The cross-sections of the first and second pressurizing chambers 1122a and 1122b may also be square, circular, oval, or polygonal. The first and second pressure chambers 1122a and 1122b may be circumferentially spaced apart from each other at any angle on the wall of the connecting tube main body 1127 so that the first pressure chamber 1122a, the second pressure chamber 1122b, and the guidewire chamber 1121 do not communicate with each other.

The shape of the first main hole 1123a and the first sub hole 1123b is not particularly limited in this embodiment. For example, the shape of the first main hole 1123a and the first sub hole 1123b on the wall surface of the connection pipe 112 may be circular, elliptical, or polygonal. Also, the shape of the second main hole 1124a and the second sub hole 1124b is not particularly limited in this embodiment. For example, the shape of the second main hole 1124a and the second sub hole 1124b on the wall surface of the connection pipe 112 may be circular, elliptical, or polygonal.

Further, the connection tube 112 includes a functional layer for enhancing mechanical properties of the connection tube. For example, the functional layer may be a reinforcing layer 1127b provided in the connection pipe 112 to increase bending resistance and kink resistance of the connection pipe 112, and/or the functional layer may be a hydrophilic coating 1127a provided at an outer surface of the connection pipe 112 to enhance smoothness of the connection pipe 112.

With continued reference to fig. 7, the inner side of the connection tube body 1127 is provided with a reinforcing layer 1127b near the guide wire lumen 1121 and/or the connection tube body 1127 is provided with a reinforcing layer 1127b near the outer surface to increase the bending and kink resistance of the connection tube 112. The specific composition and structure of the reinforcing layer in this embodiment are not particularly limited. For example, the reinforcing layer 1127b may be a metal film, a metal mesh, a metal cable or wire arranged in parallel in a certain order, or the like. Referring to fig. 7 (a), the reinforcement layer 1127b may be continuously distributed along the circumference of the connection pipe body 1127; referring to fig. 7 (b), the reinforcing layer 1127b may be distributed along the circumferential interval of the connection pipe body 1127.

Further, the reinforcing layer 1127b extends from the proximal end to the distal end of the connection tube 112, and the bending resistance and/or kink resistance of the reinforcing layer 1127b at the distal end of the connection tube 112 is less than the bending resistance and/or kink resistance of the reinforcing layer 1127b at the proximal end of the connection tube 112. Thereby facilitating the strength requirements of the proximal end during pushing and withdrawing while the distal end is sufficiently flexible to reduce stress upon contact with human tissue.

With continued reference to fig. 7, a hydrophilic coating 1127a may also be provided on the outer surface of the connection tube body 1127 to enhance the smoothness of the operation of the connection tube 112 within the human body.

In some embodiments, with continued reference to fig. 6, balloon catheter assembly 110 further includes a tailstock 113, tailstock 113 including: a first branch channel 1135, located at the proximal end of the balloon catheter assembly 110, in communication with the first secondary orifice 1123 b; a first pressurizing head 1131 in communication with the proximal end of the first branch channel 1135 to provide an interface for connection with a pressurizing device; a second branch channel 1136, located at the proximal end of the balloon catheter assembly 110, in communication with the second secondary aperture 1123 b; a second pressurizing head 1132 communicates with the proximal end of the second branch channel 1136 to provide an interface for connection with a pressurizing device.

By communicating the first branch channel 1135 with the first sub-aperture 1123b and the first pressurizing head 1131 with the first branch channel 1135, separate pressurization or depressurization of the first balloon 111a may be achieved by the first pressurizing head 1131; by communicating the second branch channel 1136 with the second auxiliary hole 1124b, and the second pressurizing head 1132 with the second branch channel 1136, separate pressurization or depressurization of the second balloon 111b may be achieved by the second pressurizing head 1132.

Further, both the first pressurizing head 1131 and the second pressurizing head 1132 may be detachably connected with an external pressurizing device to maintain the pressure inside the first balloon 111a and the second balloon 111 b.

The relative positional relationship of the first pressing head 1131 and the second pressing head 1132 is not particularly limited in this embodiment. The first pressurizing head 1131 and the second pressurizing head 1132 are distributed at intervals, so as to prevent the first branch channel 1135 and the second branch channel 1136 from communicating. For example, the angle between the first branch channel 1135 and the second branch channel 1136 may be distributed at 180 °, 90 °, or 60 °.

With continued reference to fig. 6, tailstock 113 further includes: tailstock reinforcement 1134, tailstock reinforcement 1134 is located at the proximal end of balloon catheter assembly 110, and first branch channel 1135 and second branch channel 1136 are each secured by tailstock reinforcement 1134, thereby reinforcing the robustness of first branch channel 1135 and second branch channel 1136.

Further, the balloon catheter assembly 110 further includes: connection stiffener 1126, connection stiffener 1126 being located proximal to balloon catheter assembly 110, tail stock 113 and connection tube 112 being secured by connection stiffener 1126. The connection strength of the tailstock 113 and the connection pipe 112 can be increased by the connection reinforcement 1126, and the junction of the two can be hermetically combined.

The material of the reinforcing member 1134 and the connecting reinforcing member 1126 is not particularly limited in this embodiment, and the reinforcing member 1134 and the connecting reinforcing member 1126 may be formed of a metal material or a polymer material. For example, both the stiffener 1134 and the attachment stiffener 1126 may be made of polytetrafluoroethylene.

Referring to fig. 8, in some embodiments, the delivery device includes a plurality of visualization elements 1125, the visualization elements 1125 being located at the distal end of the connection tube 112, the visualization elements 112 being configured for displaying the location of the first and second balloons 111a, 111b within the human body under the diagnostic device. When the distal end of the delivery device enters the human body, the position of the developing member 1125 in the human body can be displayed by means of the in-vitro diagnostic device, so that the operator knows the positions of the first balloon 111a and the second balloon 111b in the human body, and the accurate control of the delivery device by the operator is facilitated.

In this embodiment, referring to fig. 8, the number of developing members 1125 is three, and in addition to two developing members 1125 for displaying the positions of the first balloon 111a and the second balloon 111b in the human body under the diagnostic apparatus, one developing member 1125 for displaying the positions of other components is provided. Illustratively, the developing member 1125 includes a first developing member 1125a, a second developing member 1125b, and a third developing member 1125c, the first developing member 1125a being positioned at the distal end of the connection tube 112, the second developing member 1125b being positioned within the first balloon 111a, the third developing member 1125c being positioned within the second balloon 111 b. In this way, the first developing member 1125a displays the position of the distal end of the connection tube 112 under the diagnostic apparatus. In other embodiments, the number of developing members may be 2, 4 or 6, and the positions of the developing members may be set according to actual needs, which does not constitute a limitation on the number and positions of the developing members.

The shape of the developing member is not particularly limited in this embodiment. For example, the developing member 1125 may be shaped as a thin ring, a thin film, a cylindrical insert to be fitted on the connection pipe 112.

In some embodiments, referring to fig. 9, the delivery device 100 of the valve prosthesis further comprises an inner tube assembly 140, a handle assembly 120, and a sheath tube assembly 130. The inner tube assembly 140 includes an inner tube (not shown) that is sleeved on the connection tube 112 and a clip (not shown) that is disposed at a distal end of the inner tube to be detachably connected with the valve prosthesis. Sheath assembly 130 includes a sheath movably sleeved over the inner tube for constraining the valve prosthesis during delivery. The handle assembly 120 is located at the proximal end of the delivery device 100 and the inner tube assembly 140 remains relatively stationary with the handle assembly 120. By removably positioning the sheath over the connector tube 112 and the inner tube, the sheath bundle can be attached to the valve prosthesis and the valve prosthesis secured to the inner tube, and then after the delivery balloon catheter assembly, the inner tube assembly 140, and the sheath assembly 130 have reached the target site, the sheath is withdrawn to transition the valve prosthesis from the compressed state to the released state, effecting release of the valve prosthesis.

It should be noted that, other accessories may be added to the delivery device of the valve prosthesis provided in this embodiment, so as to assist the operation of various components and parts including the balloon catheter assembly 110, so as to facilitate the delivery of the valve prosthesis to the target position for release.

In the valve prosthesis delivery device provided in the embodiments of the present application, the balloon catheter assembly 110 has a first balloon 111a and a second balloon 111b with two different states, wherein the first balloon 111a can be used for guiding the valve prosthesis to be delivered to a target position, and the second balloon 111b can be used for judging whether the delivery device passes through chordae tendineae when delivering the valve prosthesis to the target position along a delivery path established by a guide wire, so that the balloon catheter assembly 110 can have both guiding and path exploring functions when the distal end of the delivery device enters the ventricle to the atrium through the apex of the heart. Compared with the traditional mode of adopting an additional balloon catheter to explore, after confirming that the delivery path established by the guide wire does not pass through the chordae tendineae, withdrawing the balloon catheter from the heart, and then pushing the valve prosthesis to the target position along the guide wire, the delivery device provided by the embodiment of the application can reduce the risk caused by the fact that the instrument needs to enter and exit from the apex incision for multiple times; in addition, the first balloon 111a and the second balloon 111b can be switched between the inflated state and the contracted state, that is, the diameters of the first balloon 111a and the second balloon 111b are variable, so that when the valve prosthesis is released, the first balloon 111a and the second balloon 111b can be decompressed to maintain the contracted state, and the balloon catheter assembly 110 is partially retracted, thereby being more beneficial to the deployment of the valve prosthesis, and simultaneously avoiding the damage of the distal end of the balloon catheter assembly 110 to atrial tissues when the valve prosthesis is released; after the valve prosthesis is released, when the distal end of the delivery device is withdrawn from the human body, the balloon catheter assembly 110 can be configured to be in a state when the balloon catheter assembly 110 enters the target position, namely, the first balloon 111a is in a filled state, and the second balloon 111b is in a contracted state, and due to the transition of the first balloon 111a, the risk that the distal end of the delivery device directly exits the tissue when leaving the apex of the heart, size mutation occurs, and massive hemorrhage occurs can be avoided.

According to some embodiments of the present application, another embodiment of the present application provides a method for using a delivery device of a valve prosthesis, which is applicable to the delivery device of a valve prosthesis provided in the foregoing embodiments, so as to reduce the risk of surgery. It should be noted that, in the same or corresponding parts as those of the above embodiments, reference may be made to the corresponding descriptions of the above embodiments, and detailed descriptions thereof will be omitted.

Referring to fig. 10-13, fig. 10-13 are schematic views of various steps in delivering a mitral valve prosthesis with a delivery device according to another embodiment of the present application. The following uses a transapical mitral valve repair as an example, and the application method provided in this embodiment is described in detail with reference to the accompanying drawings, and specifically includes the following steps:

referring to fig. 10, a guidewire 150 is transapically passed through the left ventricle 220, through the mitral valve 240, and into the left atrium 210, establishing a delivery path. The guide wire lumen 1121 in the connecting tube 112 of the balloon catheter assembly 110 is sleeved over the guide wire 150 and moved into the human body along the surgical path defined by the guide wire 150. And at least upon contact with the apex tissue, the first balloon is in an inflated state and the second balloon is in a deflated state, with the distal end of delivery device 100 being expanded into the apex tissue under the guidance and assistance of first balloon 111a, thereby safely accessing the left ventricle 220 from the distal end of delivery device 100.

Referring to fig. 11, pushing of balloon catheter assembly 110 continues until balloon catheter assembly 110 enters left atrium 210 with the second balloon fully exposed, then second balloon 111b is pressurized to the inflated state, then balloon catheter assembly 110 is withdrawn, and if inflated second balloon 111b can be smoothly withdrawn to left ventricle 220, the delivery path established by guidewire 150 is available; if the inflated second balloon 111b is difficult to move, the delivery path established by the guidewire 150 may pass through the chordae 230, requiring the guidewire 150 to be withdrawn to reattempt a new passageway.

Referring to fig. 12, if the established delivery path does not pass through chordae 230, the sheath in the withdrawn sheath assembly 130 is advanced near the mitral valve 240 at the distal end of the delivery device 100 to release the loaded mitral valve prosthesis. At this time, the first and second balloons 111a, 111b may be depressurized to be in a contracted state, and the balloon catheter is preferably withdrawn slightly proximally, which is more advantageous for deployment of the valve prosthesis while avoiding damage to atrial tissue by the distal end of the balloon catheter when the valve prosthesis is released.

Referring to fig. 13, when delivery device 100 is withdrawn from the heart after release of the mitral valve prosthesis, first balloon 111a is in a inflated state and second balloon 111b is in a deflated state to avoid the risk of bleeding due to abrupt changes in size of the distal end of delivery device 100 when delivery device 100 is withdrawn from the apical tissue.

The application method of the valve prosthesis delivery device provided by the embodiment of the application adopts the valve prosthesis delivery device provided by the embodiment, has the functions of exploring and delivering, can reduce the steps that the exploring balloon enters the heart of the human body and withdraws from the heart of the human body once compared with the traditional instrument, avoids the risk of bleeding during instrument exchange, reduces the burden of instrument preparation and operation, can avoid great bleeding of the heart caused by size mutation when exiting the heart, and reduces the risk of operation.

It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples of implementing the present application and that various changes in form and details may be made therein without departing from the spirit and scope of the present application.

Claims (17)

1. A valve prosthesis delivery device, comprising:

a balloon catheter assembly, the balloon catheter assembly comprising: the device comprises a connecting pipe and a first balloon and a second balloon which are arranged on the connecting pipe, wherein the first balloon and the second balloon both comprise an inflation state and a contraction state, the first balloon is arranged at the end part of the distal end of the connecting pipe, the second balloon is arranged at the distal end of the connecting pipe, the diameter of the first balloon in the inflation state is smaller than that of the second balloon in the inflation state, the first balloon is used for guiding the delivery of the valve prosthesis to a target position, and the second balloon is used for judging whether a delivery path passes through a tendon cable or not.

2. The valve prosthesis delivery device of claim 1, wherein the valve prosthesis comprises,

the second balloon is positioned at the end part of the distal end of the connecting pipe and is coated with the first balloon, or,

the second balloon is axially spaced from the first balloon and is positioned at the proximal end of the first balloon.

3. The valve prosthesis delivery device of claim 1, wherein the first balloon comprises a distal working section and a proximal working section, each of the distal working section and the proximal working section being tapered when the first balloon is in the inflated state.

4. The valve prosthesis delivery device of claim 3, wherein the included angle of the profile of the distal working segment is less than the included angle of the profile of the proximal working segment when the first balloon is in the inflated state.

5. The valve prosthesis delivery device of claim 3, further comprising:

a sheath assembly comprising a sheath movably sleeved to the connecting tube, the sheath for constraining the valve prosthesis upon delivery;

the first balloon further comprises: a first primary working segment and a first secondary working segment located between the distal working segment and the proximal working segment, the first primary working segment being located distally of the first secondary working segment;

the diameter of the first main working section is larger than or equal to the outer diameter of the sheath tube;

the diameter of the first auxiliary working section is smaller than or equal to the inner diameter of the sheath.

6. The valve prosthesis delivery device of claim 5, wherein the length of the first primary working segment is greater than the length of the first secondary working segment in a direction along the extension of the balloon catheter assembly.

7. The valve prosthesis delivery device of claim 1, wherein the second balloon is balloon-shaped, drum-shaped, lantern-shaped, or shuttle-shaped in the inflated state.

8. The valve prosthesis delivery device of claim 1, wherein the connection tube comprises a connection tube body and a guidewire lumen extending axially through the connection tube body for passage of a guidewire.

9. The valve prosthesis delivery device of claim 8, wherein the connecting tube comprises:

a first pressurizing cavity extending along the axial direction of the connecting pipe body, wherein the distal end of the first pressurizing cavity is communicated with the first balloon through a first main hole of the outer wall of the connecting pipe body, the proximal end of the first pressurizing cavity is communicated with the outside through a first auxiliary hole of the outer wall of the connecting pipe body, and the first pressurizing cavity is used for realizing that the first balloon is in a filling state or a shrinking state;

the second pressurizing cavity extends along the axial direction of the connecting pipe main body, the distal end of the second pressurizing cavity is communicated with the second balloon through a second main hole of the outer wall of the connecting pipe main body, the proximal end of the second pressurizing cavity is communicated with the outside through a second auxiliary hole of the outer wall of the connecting pipe main body, and the second pressurizing cavity is used for realizing that the second balloon is in a filling state or a shrinking state.

10. The valve prosthesis delivery device of claim 9, wherein the balloon catheter assembly further comprises a tailstock comprising:

a first branch channel located at the proximal end of the balloon catheter assembly, communicating with the first secondary bore, to provide an interface for connection with a pressurizing device;

a first pressurizing head in communication with the proximal end of the first branch channel;

a second branch channel located at the proximal end of the balloon catheter assembly and communicating with the second auxiliary hole to provide an interface for connection with the pressurizing device;

and the second pressurizing head is communicated with the proximal end of the second branch channel.

11. The valve prosthesis delivery device of claim 10, wherein the tailstock further comprises: and the tail seat reinforcement is positioned at the proximal end of the balloon catheter assembly, and the first branch channel and the second branch channel are both fixed through the tail seat reinforcement.

12. The valve prosthesis delivery device of claim 10, wherein the balloon catheter assembly further comprises: and the connecting reinforcement is positioned at the proximal end of the balloon catheter assembly, and the tailstock and the connecting pipe are fixed through the connecting reinforcement.

13. The valve prosthesis delivery device of claim 1, wherein the connection tube comprises a functional layer for enhancing mechanical properties of the connection tube.

14. The delivery device of a valve prosthesis of claim 13, wherein the functional layer is a reinforcing layer disposed in the connecting tube to increase the bending resistance and/or kink resistance of the connecting tube and/or a hydrophilic coating disposed on an outer surface of the connecting tube to enhance the smoothness of the connecting tube.

15. The delivery device of a valve prosthesis of claim 14, wherein the reinforcement layer extends from the proximal end of the connecting tube to the distal end of the connecting tube, and wherein the reinforcement layer has a resistance to bending and/or kink at the distal end of the connecting tube that is less than the resistance to bending and/or kink at the proximal end of the connecting tube.

16. The valve prosthesis delivery device of claim 1, comprising a plurality of visualization elements located at a distal end of the connecting tube, the visualization elements configured to display the location of the first balloon and the second balloon within the human body under a diagnostic device.

17. The valve prosthesis delivery device of claim 1, further comprising: an inner tube assembly, a handle assembly, and a sheath assembly;

the inner tube assembly comprises an inner tube and a buckle, the inner tube is sleeved on the connecting tube, and the buckle is arranged at the distal end of the inner tube so as to be detachably connected with the valve prosthesis;

the sheath assembly includes a sheath movably sleeved to the inner tube, the sheath for constraining the valve prosthesis during delivery;

the handle assembly is positioned at the proximal end of the delivery device, and the inner tube assembly remains relatively stationary with the handle assembly.

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