CN212490261U - Heart valve thread placing device - Google Patents

Abstract

The application discloses heart valve wire setting ware, it includes: the pipe, first buckle part, second buckle part, with the line of first buckle part fixed connection, at least part wear to establish first power transmission part and second power transmission part in the pipe, the pipe includes in proper order: an extension section, an operation section and an optional protection section. The operating section is pushed to a heart valve position through a catheter intervention valve repair technology, then the first buckle part and the second buckle part move oppositely from two sides of the valve through power provided by the first power transmission part and the second power transmission part to form a buckle connection, and therefore the first buckle part, the second buckle part and a wire fixedly connected with the first buckle part are anchored on the valve.

Description

Heart valve thread placing device

Technical Field

The application relates to the technical field of medical equipment, in particular to a heart valve thread placing device and a method for treating heart diseases by adopting the same.

Background

The heart valve controls the flow of blood in the heart, wherein the mitral valve is located between the left atrium and the left ventricle, the tricuspid valve is located between the right atrium and the right ventricle, and the normally functioning heart valve is like a one-way valve and is opened and closed regularly in the heart to allow the blood to flow from the atrium to the ventricle in a single direction. For example, common heart valve disease Mitral Regurgitation (MR) is caused by mitral insufficiency, epidemiological data show that the prevalence rate of MR in people over sixty years in our country is as high as 13.4%, and the prevalence rate of MR in moderate and severe MR patients requiring clinical intervention is about 1000 ten thousand.

Compared with the defects of large trauma, obvious postoperative pain, slow recovery, high risk and the like in surgical treatment, the minimally invasive intervention repair technology becomes a new treatment means, more products for treating the mitral valve diseases by using a domestic and external minimally invasive intervention method exist, a small number of products for treating the tricuspid valve diseases by using the minimally invasive intervention method exist, and the minimally invasive intervention repair technology is a universal product for treating the mitral valve and the tricuspid valve respectively. For example, MitraClip, PASCAL, ValveCleam, Cardioband, Mitralign, Neochord and the like all adopt a minimally invasive interventional repair technology, wherein MitraClip of Evalve is the only internationally approved minimally invasive interventional instrument for treating MR, the price is high, the success rate is lower than 60%, and mitral stenosis is easily caused.

Therefore, a universal minimally invasive intervention repair instrument for heart valves, which has the advantages of simple structure, low cost, easy operation and ideal effect, is needed.

SUMMERY OF THE UTILITY MODEL

The invention provides a heart valve wire placing device, a knotting device and a wire shearing device which are matched with the wire placing device, and a method for treating heart diseases by adopting the wire placing device.

The technical scheme for solving the technical problems comprises the following contents:

embodiment 1. a heart valve wire applier, comprising: a conduit, a first snap member, a second snap member, a wire at least partially disposed through the conduit and fixedly connected to the first snap member, a first power transmission member at least partially disposed through the conduit, the first power transmission member being releasably connectable with the first snap member;

the catheter comprises in sequence: an extension section, an operation section and an optional protection section; a first buckle component direction guider is arranged at the near end of the operation section, and a guide channel for the first power transmission component to pass through is arranged on the first buckle component direction guider; a second snap member connector is provided on the operative section, the second snap member connector being rotatably connected at a distal end to the catheter;

a second power transfer component at least partially disposed through the conduit, the second power transfer component connected with the second snap component connector, the second snap component connector detachably connectable with the second snap component;

such that, when the second power transmission part applies an opening rotational power to the second catch part connector, the second catch part connector rotates and forms a fixed angle with the operating section, the direction of the guide channel being directed towards the second catch part, when the first power transmission part applies an advancing power to the first catch part, the first catch part forms a catch connection with the second catch part.

Embodiment 2. the heart valve wire applier of embodiment 1, wherein the first snap feature is a snap feature and the second snap feature is a snap feature; or, the first buckle part is a clamping part, and the second buckle part is a buckle part.

Embodiment 3. the heart valve wire introducer of embodiment 1, wherein the first snap member direction guide is one or more metal tubes fixedly arranged on the catheter, and the inner part of the metal tubes is the guide channel.

Embodiment 4 the heart valve applicator of embodiment 1, wherein the fixed angle is a right angle or an acute angle, such as about 90 degrees, 20 degrees to 60 degrees, or 30 degrees to 50 degrees.

Embodiment 5. the heart valve wire introducer of embodiment 1, wherein the distal end of the first power transmission member is externally threaded and the rear portion of the first snap member is internally threaded, the first power transmission member and the first snap member being releasably coupled by the internal and external threads.

Embodiment 6 the heart valve wire applier of embodiment 1 or 2, wherein the catheter is provided with a side opening at the operative section, and the first snap member, the second snap member and the second snap member connector are provided at the side opening of the catheter.

Embodiment 7 the heart valve wire applier of embodiment 1, wherein the catheter is provided with a shaft at a distal end of the operative section, and the second snap member connector is provided with a shaft hole, and the second snap member connector is rotatably connected with the catheter by the shaft and the shaft hole.

Embodiment 8 the heart valve wire applier of embodiment 1, wherein the first power transmission member comprises a high memory steel wire.

Embodiment 9. the heart valve wire applier of embodiment 1, wherein the length of the operative segment is 2 to 3 centimeters; the second snap part connector has a length of 1.8 to 2.7 centimeters.

Embodiment 10 the heart valve wire applier of embodiment 1, wherein the second snap member snaps over an end of the second snap member connector.

Embodiment 11. the heart valve wire-placing device according to embodiment 2, wherein the locking member has an annular through hole for passing the fastening member therethrough and a locking tongue disposed in the annular through hole, the locking tongue is an elastic member with a certain flexibility, the fastening member has a sharp head capable of passing through the annular through hole, and an extension portion connected with the sharp head and having at least one locking groove, when the sharp head passes through the annular through hole, the locking tongue abuts against the locking groove, thereby forming a locking connection.

Embodiment 12 the heart valve wire applier of embodiment 11, wherein a cross-sectional area of the clip member is greater than 0.1 square centimeters to provide better force distribution.

Embodiment 13 the heart valve wire applier of embodiment 11 or 12, wherein the clasp member further has a tail connected to the extension portion, the tail having a cross-sectional area greater than 0.1 square centimeters removed from the extension portion.

Embodiment 14 the heart valve wire applier of embodiment 13, wherein after the first and second snap members form a snap connection, a distance between the tail of the snap member and the snap member is 0.5mm to 2 mm.

Embodiment 15 the heart valve wire applier of embodiment 11, wherein the clip member has a protection portion corresponding to the sharp head of the clip member, the protection portion being externally rounded.

Embodiment 16 the heart valve applicator of embodiment 1, wherein a visualization marker is disposed on at least one component, for example, on the distal end of the catheter.

Embodiment 17. the heart valve wire applier of embodiment 13, wherein the tail of the clasp member and the catch member each independently comprise at least two layers: a support layer for providing structural support, and a biocompatible layer for providing biocompatibility, wherein the support layer has a plurality of sharp protrusions with a diameter of 0.3mm to 2.0mm extending toward the biocompatible layer for enhancing valve fixation.

Embodiment 18 the heart valve wire applier of embodiment 17, wherein the support layer providing structural support is made of metal or rigid plastic.

Embodiment 19. the heart valve wire applier of embodiment 1, wherein the protective segment has rounded ends made of a soft material.

Embodiment 20. a knot-line device, comprising: a knot line conduit; the knot wire clamp is arranged at the end part of the knot wire conduit and is provided with an opening which is automatically closed; a wire tube which is at least partially arranged in the wire connecting conduit in a penetrating way and the end part of which is pre-clamped in the opening of the wire connecting clamp; a stop disposed on the knot line conduit proximate the knot line.

Embodiment 21 the knot device of embodiment 21, wherein the knot cord is a self-cinching loop formed of high memory steel sheet.

Embodiment 22 the wire knotter of embodiment 21, further comprising a wire pre-threaded into the conduit.

Embodiment 23. a wire trimmer comprising a wire trimming catheter; the scissors are arranged at the end part of the trimming guide pipe; a power transmission member connected with the scissors so as to enable the scissors to perform a cutting operation.

Embodiment 24. the wire trimmer of embodiment 23, wherein the wire shears comprises a blade connected to the power transmission member and a shear plate connected to the blade by a resilient connector and positioned perpendicular to the blade, wherein the resilient connector maintains the blade in a spaced relation from the shear plate, and wherein the wire cutting guide further comprises a wire slot in a side wall of the end of the wire cutting guide, the wire slot being adapted to guide the wire into the spaced relation between the blade and the shear plate.

Embodiment 25 the wire trimmer of embodiment 24 wherein said blade is disposed parallel to the axis of said wire trimming guide and said shear plate is disposed perpendicular to the axis of said wire trimming guide.

Embodiment 26 the wire cutter of embodiment 25, wherein the number of the blades and the shear plate is two, and two helically extending wire grooves are correspondingly provided.

Embodiment 27. a method of treating a heart condition, comprising securing a first end of a first thread to a first heart valve, securing a first end of a second thread to a second heart valve, and forming a knot between the first thread and the second thread through a second end of the first thread and a second end of the second thread to create a pull between the first heart valve and the second heart valve to reduce a distance between the first heart valve and the second heart valve, the first heart valve and the second heart valve being the same or different valves.

Embodiment 28. the method of treating a heart condition of embodiment 27, comprising forming a first clip member and a first clip member on the first heart valve, the first clip member forming a snap fit connection with the first clip member through the first heart valve, the first end of the first wire being connected to at least one of the first clip member and the first clip member;

the second heart valve is provided with a second clamping part and a second buckling part, the second buckling part penetrates through the second heart valve to be in buckling connection with the second clamping part, and the first end of the second wire is connected with at least one of the second clamping part and the second buckling part.

Embodiment 29 the method of treating a heart condition of embodiment 27, wherein the step of securing the first end of the first wire to the first heart valve is performed by the apparatus of any of embodiments 1-19, and the step of securing the first end of the second wire to the second heart valve is performed by the apparatus of any of embodiments 1-19.

The unexpected technical effect brought by the application is that: adopt the buckle to connect, anchor the line on the valve from the atrium side, easy operation is rapid, does not influence valve work, simultaneously through knot line and the trimming operation at the atrium side, draws the line knot, can draw close the clearance of mitral valve or tricuspid valve, effectively solves mitral valve or tricuspid valve regurgitation.

Drawings

To more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings in the specification will be briefly described below, and it should be apparent that the drawings in the following description are only related to some embodiments of the present disclosure, and do not limit the present disclosure.

FIG. 1 is a schematic view of a heart valve deployment device;

FIG. 2 is a schematic view of a heart valve deployment device forming a snap-fit arrangement;

FIG. 3 is a schematic view of a card member and a clasp member;

FIG. 4 is a schematic view of the heart valve suture applicator anchored to the valve;

FIG. 5 is a schematic view of the knot tying device;

FIG. 6 is a schematic view of a thread trimmer;

FIG. 7 is a schematic representation of a mitral valve line;

FIG. 8 is a schematic view of mitral valve line placement reducing valve spacing;

FIG. 9 is a schematic view of mitral valve line placement reducing valve spacing;

fig. 10 is a schematic view of tricuspid valve line reduction valve spacing.

Description of the reference numerals

100-first snap part, 101-snap part, 102-sharp head, 103-bayonet slot, 104-extension, 105-tail, 110-first power transfer part, 120-first snap part direction guide;

200-a second snap part, 201-a snap part, 202-a circular through hole, 203-a snap tongue, 204-a protection part, 205-a support layer, 206-a biocompatible layer, 207-a sharp protrusion, 210-a second snap part connector, 211-a shaft hole, 220-a second power transmission part;

300-a catheter, 310-an extension section, 320-an operation section, 321-a side opening, 322-a rotating shaft and 330-a protection section;

400-line;

500-a valve;

600-knot device, 610-knot catheter, 620-knot wire card, 630-wire tube, 640-stopping part;

700-wire cutter, 710-wire cutting catheter, 720-scissors, 721-blade, 722-elastic connecting piece, 723-shearing plate, 724-wire groove and 730-power transmission component.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present disclosure more apparent, the technical solutions of the embodiments of the present disclosure will be described clearly and completely with reference to the drawings of the embodiments of the present disclosure. It is to be understood that the described embodiments are only a few embodiments of the present disclosure, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the disclosure without any inventive step, are within the scope of protection of the disclosure.

In the present application, each term has a meaning generally understood in the art, unless otherwise indicated or a different meaning can be derived from the context.

One aspect of the present application discloses a heart valve thread applicator, which includes: a conduit, a first snap member, a second snap member, a wire at least partially disposed through the conduit and fixedly connected to the first snap member, a first power transmission member at least partially disposed through the conduit, the first power transmission member being releasably connectable with the first snap member; the catheter comprises in sequence: an extension section, an operation section and an optional protection section; a first buckle component direction guider is arranged at the near end of the operation section, and a guide channel for the first power transmission component to pass through is arranged on the first buckle component direction guider; a second snap member connector is provided on the operative section, the second snap member connector being rotatably connected at a distal end to the catheter; a second power transfer component at least partially disposed through the conduit, the second power transfer component connected with the second snap component connector, the second snap component connector detachably connectable with the second snap component; such that, when the second power transmission part applies an opening rotational power to the second catch part connector, the second catch part connector rotates and forms a fixed angle with the operating section, the direction of the guide channel being directed towards the second catch part, when the first power transmission part applies an advancing power to the first catch part, the first catch part forms a catch connection with the second catch part.

The heart valve wire placing device is used for anchoring a wire on a heart valve, the wire can be a medical traction wire or a medical suture wire, the operation section is pushed to the position of the heart valve through a catheter intervention valve repair technology, then the first buckling part and the second buckling part move towards each other from two sides of the valve by the power provided by the first power transmission part and the second power transmission part to form a buckling connection, and is positioned on the valve, the first power transmission part and the second buckling part are separated from each other, the first snap part, the second snap part, the wire being fixedly connected with the first snap part are anchored to the valve, a wire connected with the first catch part is formed on the atrial side, which wire can exert a traction force on the valve by means of the catch construction, so that the treatment is carried out.

Snap connection the snap connection described herein has the meaning commonly understood by a person skilled in the art, in particular an embedded latching connection between the first and the second snap part, comprising a sharp head for piercing the valve, and further comprising an elastic part with a certain flexibility, which deforms and springs back upon snap connection, thereby enabling latching of the first and the second snap part. This application is through the atrium side first buckle part and atrium side second buckle part between the relative motion, puncture the valve rapidly on single action point and form the buckle and connect, operating time is short, and is minimum to the influence of valve work. Simultaneously, the line with first buckle part is connected to make the line of anchoring be located the atrium side of valve, not influence the work of valve and chordae tendinae, also be favorable to subsequent operation very much. It should be noted that the term "moving towards each other" in the present application includes both the two components approaching each other at the same time, and the two components moving towards each other one after the other.

The advancing direction of the first buckle part is controlled by arranging a first buckle part direction guide, a guide channel for the first power transmission part to pass through is arranged on the first buckle part direction guide, the guide direction of the guide channel points to the second buckle part in an opening state, and when the first power transmission part applies longitudinal power to the first buckle part (namely, power along the axial direction of a catheter shaft), the first buckle part is ensured to advance according to a specified route. The arrangement form of the guide channel is not particularly limited, and only needs to play a role of guiding as required, and may be, for example, a closed channel, an open channel, or a channel (e.g., a plurality of collars) composed of a plurality of position fixing devices which can play a role of guiding, and the like.

The second buckling part connector is arranged at the far end of the operation section and is rotatably connected with the catheter, the second buckling part can be driven to move to a preset position from the inside of the catheter on the heart chamber side through adjusting the length and the rotating angle of the second buckling part connector, and the first buckling part and the second buckling part can be in buckling connection through combining the first buckling part direction guide.

In the present application, the first power transmission part and the first buckle part, the second buckle part connector and the second buckle part are both detachably connected, so that, after the first buckle part and the second buckle part form a buckle connection and are positioned on the valve, the first power transmission part and the second buckle part connector are separated as soon as possible, and the valve operation is prevented from being affected. In the present application, the form of the releasable connection is not particularly limited as long as the desired purpose can be achieved.

[ PROTECTING SECTION ] this application still is provided with optional protection section, the protection section is located the pipe end, plays the guard action to the heart in the operation process, avoids the pipe damage heart in the operation process. The protective segment may be formed by a flexible shape and/or material.

In some embodiments, the first snap member is a snap member and the second snap member is a card member; or, the first buckle part is a clamping part, and the second buckle part is a buckle part. As mentioned before, the snap connection is an embedded latching connection between two parts comprising a catch part and a catch part, the catch part in this application being a part comprising a sharp-headed piercing valve which after passing through the valve is inserted/passed through the catch part, thereby forming a snap connection, the first catch part can be either a catch part or a catch part, respectively the second catch part can be either a catch part or a catch part. In a preferred embodiment, the first snap part is a snap part and the second snap part is a snap part, since this configuration will protect the heart more effectively, and the snap part with a sharp head comes out of the catheter and into the snap part, reducing the possibility of damage to the heart. In this application, the terms insertion and penetration have the same meaning in describing the moving relationship between the snaps, and refer to a process in which at least a portion of the snap part enters the through hole of the card part to form the snap connection.

In some embodiments, the first snap member direction guide is one or more metal tubes fixedly disposed on the catheter, and the interior of the metal tubes is the guide channel. The metal pipe is convenient and fast to arrange, can be a closed pipeline, and also can be an open pipeline with an opening on the pipe wall, as long as the first buckle part and the second buckle part can be guided to form buckle connection.

In some embodiments, the fixed angle is a right angle or an acute angle, such as about 90 degrees, 20 degrees to 60 degrees, or 30 degrees to 50 degrees. When the operation section is located at the position of the valve, the second buckle part connector is opened and rotated under the action of the second power transmission part and forms a fixed angle with the operation section. During the rotation process, the second buckle component connector drives the second buckle component to advance to the ventricle side of the valve, and a person skilled in the art understands that the travel distance should be as small as possible to avoid unnecessary damage caused by touching other parts of the heart, therefore, the second buckle component connector is connected with the catheter at the far end of the operation section, at this time, when the formed fixed angle is a right angle or an acute angle, the second buckle component can advance to a proper position at the ventricle side of the valve with a minimum moving distance to match with the shape of the valve, and the position of the second buckle component close to the valve at the ventricle side can be adjusted according to the size of the rotation angle and the length of the second buckle component connector, so that the position of the buckle component anchored to the valve can be conveniently adjusted.

In some embodiments, the distal end of the first power transmission member is formed with an external thread, and the rear portion of the first snap member is formed with an internal thread, and the first power transmission member and the first snap member are detachably connected by the internal thread and the external thread. When the first buckle part and the second buckle part form a buckle connection and are positioned on the valve, the first power transmission part can be separated from the first buckle part by rotating the first power transmission part.

In some embodiments, the conduit is provided with a side opening at the operative section, the first snap part, the second snap part and the second snap part connector being provided at the side opening of the conduit. The side opening should have a length greater than the length of the second snap part connector and a width enabling the first and second snap parts to travel from the side opening to a predetermined position.

In some embodiments, the catheter tube is provided with a shaft at the distal end of the operating section, and the second snap member connector is provided with a shaft hole, and the second snap member connector is rotatably connected with the catheter tube through the shaft and the shaft hole. The skilled person can select different connection modes to realize different transmission modes, for example, the second power transmission part can be connected to the distal end of the second buckle part connector relative to the position of the shaft hole, or can be connected to the proximal end of the second buckle part connector relative to the position of the shaft hole, and the second buckle part connector can be rotated by pushing and pulling the second power transmission part.

In some embodiments, the first power transmitting component comprises a high memory steel wire. The high-memory steel wire has high strength, good flexibility and light weight, and is a preferred material for the first power transmission component. The first power transmission member made of a high memory wire is restored to a shape after protruding from the guide passage, thereby advancing the first engaging member in a predetermined direction to form an engaging connection with the second engaging member.

The operating section needs to extend through the atrium and ventricle of the heart at the valve, with a length that corresponds to the size of the human heart, and the second catch member connector drives the second catch member within the ventricle to travel onto the ventricular side valve, with a length that enables the second catch member to be positioned at a suitable location on the valve, for example near the valve's root or at the annulus. One skilled in the art can select the appropriate size depending on the patient's particular situation, and in some embodiments, the length of the operative section is 2 to 3 centimeters and the length of the second snap member connector is 1.8 to 2.7 centimeters. In one embodiment, the length of the operative section is from 1 cm to 7 cm.

In some embodiments, the second snap member snaps onto an end of the second snap member connector. After the snap connection has been made, the second snap part can be disengaged from the second snap part connector by pulling on the first power transmission part, and the skilled person will be able to suitably arrange the snap means such that the first power transmission part and the second snap part connector can be quickly disengaged by an atrial side operation, thereby reducing the negative impact on the valve operation.

In some embodiments, the clip member has an annular through hole for the buckle member to be inserted into, and a clip tongue disposed in the annular through hole, the clip tongue is an elastic member having a certain flexibility, the buckle member has a sharp head capable of passing through the annular through hole, and an extension portion connected to the sharp head and having at least one clip groove, when the sharp head passes through the annular through hole, the clip tongue abuts against the clip groove, thereby forming a clip connection. The technical personnel in the field can rationally set up different buckle connection structure, for example the draw-in groove can have a plurality ofly, when having a plurality of draw-in grooves, can be according to the thickness of valve, through the draw-in groove quantity that passes, adjust the clearance between the buckle structure to make buckle structure adapt to the thickness of valve better.

In some embodiments, the cross-sectional area of the clip member is not small enough to cause concentrated force on the valve at some point. In the present application, the cross section of the clamping member refers to a contact surface of the clamping member and the valve, and a person skilled in the art can select the cross section according to actual conditions, for example, when the cross section is set to be larger than 0.1 square centimeter, the force can be dispersed, and the valve is prevented from being damaged.

In some embodiments, the clasp member also has a tail portion connected to the extension portion to enable better fixation to the valve. The contact area of the tail part and the valve is not too small, otherwise, the concentrated stress at a certain point of the valve can be caused. The person skilled in the art can choose the method according to the actual situation, for example, the tail part is arranged to remove the cross-sectional area of the extension part more than 0.1 square centimeter, so that the force can be dispersed and the damage to the valve can be avoided.

In some embodiments, after the first and second snap parts form a snap connection, a gap between the tail of the snap part and the card part is 0.5mm to 2 mm. The distance of the gap depends on the thickness of the valve, so that the buckling structure can clamp the valve and does not slide with the valve, and the valve is prevented from being damaged by the extension part in the buckling structure.

In some embodiments, the card member has a protection portion corresponding to a sharp head of the buckle member, the protection portion being externally rounded. In order to make the buckle part capable of puncturing the valve, the buckle part is provided with a sharp head, in some embodiments, after the sharp head of the buckle part is embedded into the clamping part to form a clamping connection, the sharp head extends to the other side of the clamping part, and in order to prevent the sharp head from puncturing other parts of the heart, the clamping part is provided with a corresponding smooth protection part for covering the sharp head.

In some embodiments, the heart valve applicator is provided with a visualization marker on at least one component, such as a visualization marker on the distal end of the catheter. The developing marker can assist a doctor to see the position of the wire placing device in the body of the patient in real time, and the operation can be accurately controlled. The developing label itself is not limited, and those skilled in the art can select the developing label according to actual needs.

In some embodiments, the tail portion of the clasp member and the card member each independently comprise at least two layers: a support layer to provide structural support, and a biocompatible layer to provide biocompatibility. The skilled person knows how to arrange the specific positional relationship between the two layers according to the actual need, and in general the biocompatible layer is arranged on the side in direct contact with the heart valve. In a specific embodiment, the support layer has a plurality of sharp protrusions of 0.3mm to 2.0mm (e.g., 0.3mm to 0.8mm, e.g., 0.5mm) extending toward the biocompatible layer to enhance the valve fixation. The sharp protrusions enable the clamping parts and the buckling parts to tightly bite the valve like teeth when the buckling structures are formed on the valve, and the fixing effect of the valve is enhanced.

In some embodiments, the support layer providing structural support is made of metal or rigid plastic and the biocompatible layer providing biocompatibility is made of a thermoplastic polyurethane material. Thermoplastic polyurethane material is a commonly used biocompatible material and is very suitable for use in the solution of the present application.

In some embodiments, the protective segment has a rounded tip made of a soft material, such as a thermoplastic polyurethane material, capable of protecting the heart from damage from hard portions of the catheter. In a specific embodiment, the protection section is a pigtail section made of a soft material, the outer diameter of the tube at the tail end of the pigtail section is 1-3mm, a ring with the diameter of 7 mm-13 mm is formed at the end part of the pigtail section, a guide wire through hole is formed, and the pigtail section can be abutted against the bottom of an atrium and plays a stabilizing role in operation. Those skilled in the art will appreciate that the particular length of the protective segment may be specifically adjusted depending on the condition of the heart and the particular shape of the protective segment.

This application another aspect provides a knot line ware, it includes: a knot line conduit; the knot wire clamp is arranged at the end part of the knot wire conduit and is provided with an opening which is automatically closed; a conduit tube at least partially threaded into the conduit and having an end portion pre-clamped in an opening of the tie wire clip; a stop disposed on the knot line conduit proximate the knot line. In one embodiment, the tie clip may be a clip.

In some embodiments, the tie line clip is a self-cinching loop formed from high memory steel.

In some embodiments, the knot device further comprises a wire pre-threaded in the conduit.

The application also provides a thread trimmer, it includes: a trimming guide pipe; the scissors are arranged at the end part of the trimming guide pipe; a power transmission member connected with the scissors so as to enable the scissors to perform a cutting operation. The person skilled in the art can arrange a reasonable structure to perform the thread cutting, for example, the scissors comprise two blades, and under the action of the power transmission part, the two blades move towards each other to perform the cutting operation.

In some embodiments, the scissors comprise a blade connected to the power transmission member, and a cutting plate connected to the blade through an elastic connector and disposed perpendicular to the blade, wherein the elastic connector keeps the blade spaced apart from the cutting plate, and a wire slot is further disposed on a side wall of an end portion of the cutting wire guide, and the wire slot guides the wire into the gap between the blade and the cutting plate. The power transmission part drives the blade to move and complete shearing operation on the shearing plate, and after the power transmission part is released, the elastic connecting piece enables the blade to automatically rebound to an initial position.

In some embodiments, the blade is disposed parallel to an axis of the trimming guide tube and the shear plate is disposed perpendicular to the axis of the trimming guide tube.

In some embodiments, the number of the blades and the shear plate is two, and two helically extending wire grooves are correspondingly provided. The two blades, the shearing plate and the wire grooves are oppositely arranged in the wire shearing guide pipe, the wire grooves extending spirally can enable the wires to be kept stable and avoid separation, and therefore the two wires can be sheared on opposite sides in the wire shearing guide pipe at the same time.

The present application further provides a method of treating a heart condition comprising securing a first end of a first thread to a first heart valve, securing a first end of a second thread to a second heart valve, and forming a knot between the first thread and the second thread through a second end of the first thread and a second end of the second thread to form a pull between the first heart valve and the second heart valve to reduce a distance between the first heart valve and the second heart valve, the first heart valve and the second heart valve being the same or different valves.

In some embodiments, the method of treating a heart disease comprises forming a first clip member and a first clip member on the first heart valve, the first clip member forming a snap fit connection with the first clip member through the first heart valve, the first end of the first wire being connected to at least one of the first clip member and the first clip member; the second heart valve is provided with a second clamping part and a second buckling part, the second buckling part penetrates through the second heart valve to be in buckling connection with the second clamping part, the first end of the second thread is connected with at least one of the second clamping part and the second buckling part, and the first heart valve and the second heart valve are the same or different valves.

In some embodiments, the step of securing the first end of the first wire to the first heart valve is performed by a heart valve applier and the step of securing the first end of the second wire to the second heart valve is performed by a heart valve applier.

The present application further provides a heart valve treatment system including at least two wire introducers as described herein, at least one knotter, and at least one wire trimmer. In some embodiments, the knot device is any of the knot devices described herein. In some embodiments, the knot device is any of the wire cutters described herein.

The choice of materials and the preparation method of the thread placing device, the thread tying device and the thread cutting device in the application are selected by the person skilled in the art according to the prior art, and reference can be made to the prior art documents or the related products.

In one embodiment of the wire applier, the present application provides a heart valve wire applier comprising:

a guide pipe is arranged in the guide pipe,

a card member for mounting the card member to the card housing,

the buckling component is arranged on the base plate,

a wire at least partially threaded through the conduit and fixedly connected to the clasp member,

a buckle power transmission member at least partially disposed through the conduit, the buckle power transmission member being releasably connectable with the buckle member;

the catheter comprises in sequence: an extension section, an operation section and an optional protection section;

a buckle component direction guider is arranged at the near end of the operation section, a guide channel for the buckle power transmission component to pass through is arranged on the buckle component direction guider, (the direction of the guide channel points to the buckle component in an open state, and when the buckle power transmission component applies longitudinal power to the buckle component, the buckle component is ensured to move along a specified route);

the operating section is provided with a clamping part connector which is rotatably connected with the conduit;

a card power transmission member at least partially inserted into the conduit, the card power transmission member being connected to the card member connector, the card member connector being detachably connected to the card member;

so that, when the card power transmission part applies an opening rotational power to the card member connector, the card member connector rotates and forms a fixed angle with the operation section, and the direction of the guide passage is directed toward the card member, and at this time, the buckle member forms a snap-fit connection with the card member when the buckle power transmission part applies an advancing power to the buckle member.

The technical features described in other parts of the application are also applicable to the above solutions.

The ranges or individual features in the technical solutions described above in the present application can be used alone or in combination. The present application can be more easily understood by the following examples.

Examples

Example 1 [ femoral vein- -right atrium- -interatrial septum- -left atrium- -mitral valve ]

The present embodiment provides an apparatus for treating mitral insufficiency comprising a heart valve introducer, a thread binder 600 and a thread cutter 700.

Referring to fig. 1, 2(a), (b), (c), the heart valve applicator comprises:

a catheter 300, said catheter 300 comprising in sequence: the extension section 310, the operation section 320 and the protection section 330, wherein the protection section 330 has a smooth end made of thermoplastic polyurethane material, the distal end of the operation section 320 is provided with a developing marker, and the operation section 320 is provided with a side opening 321;

a first buckle part 100 and a second buckle part 200, wherein the first buckle part 100 is a buckle part 101, and the second buckle part 200 is a card part 201;

a wire 400 inserted into the guide tube 300 and fixedly connected to the first engaging member 100, a first power transmission member 110 inserted into the guide tube 300, and a second power transmission member 220. The first power transmission member 110 is made of a high memory steel wire and has an external thread formed at a distal end thereof, and an internal thread is formed at a rear portion of the first snap member 100, and the first power transmission member 110 and the first snap member 100 are detachably coupled by the internal thread and the external thread.

The proximal end of the operation section 320 is provided with a first snap member direction guide 120, and the first snap member direction guide 120 is a metal tube fixedly disposed on the catheter 300 and provided with a guide channel for the first power transmission member 110 to pass through.

The operating section 320 is 3 cm long, a rotating shaft 322 is arranged at the far end of the operating section, a second buckle part connector 210 with a corresponding shaft hole is rotatably connected with the rotating shaft 322, the second power transmission part 220 is connected with the second buckle part connector 210 at the far end of the shaft hole, so that the second buckle part connector 210 can be rotated and opened by pulling the second power transmission part 220 and forms a 45-degree included angle with the operating section 320, and the direction of the guide channel points to the second buckle part 200; the second snap member connector 210 is 2.5 cm long, and the second snap member 200 is snapped into the end of the second snap member connector 210. The first catch part 100, the second catch part 200 and the second catch part connector 210 are arranged at a side opening 321 of the operating section 320.

Referring to fig. 3(a) and (b), the fastening member 201 has an annular through hole 202 for the fastening member 101 to be inserted into and a fastening tongue 203 disposed in the annular through hole 202, the fastening tongue 203 is an elastic member with a certain flexibility, the fastening member 101 has a sharp head 102 inserted into the annular through hole 202, an extension 104 connected to the sharp head 102 and having a plurality of fastening grooves 103, and a tail 105 connected to the extension 104, wherein when the sharp head 102 is inserted into the annular through hole 202, the fastening tongue 203 abuts against the fastening grooves 103, thereby forming a snap connection. The cross-sectional areas of the card member 201 and the tail portion 105 of the buckle member 101 except the extension portion 104 are each about 0.11 square centimeters, and the gap between the tail portion 105 of the buckle member 101 and the card member 201 may be 1 mm.

Referring to fig. 4(a), the operation segment 320 is pushed to the heart valve position by a catheter intervention valve repair technique, and then the buckle part 101 and the clip part 201 are moved from both sides of the valve 500 to form a snap connection by the power provided by the first power transmission part 110 and the second power transmission part 220 and are positioned on the valve 500. After the snap connection is formed, the clip member 201 can be disengaged from the second snap member connector 210 by pulling the first power transmission member 110, and then the first power transmission member 110 is rotated to be disengaged from the button member 101, and the button member 101, the clip member 201, and the wire 400 fixedly connected to the button member 101 are anchored to the valve 500.

Referring to fig. 4(b), in order to prevent the sharp head 102 from pricking other parts of the heart, a rounded protection portion 204 may be further disposed on the clip member 201 to cover the sharp head 102. The clip member 201 includes a support layer 205 providing structural support and a biocompatible layer 206 providing biocompatibility, and the tail portion 105 of the clip member 101 also has the above-mentioned two-layer structure, wherein the biocompatible layer 206 is made of a thermoplastic polyurethane material and is disposed on the contact surface of the valve 500.

Referring to fig. 4(c), the following structure may be selected in this embodiment: the clip member 201 includes a support layer 205 providing structural support and a biocompatible layer 206 providing biocompatibility, wherein the support layer 205 has a plurality of 0.5mm sharp protrusions 207 extending toward the biocompatible layer 206, and the tail 105 of the clip member 101 also has the above two-layer structure and sharp protrusions, thereby enhancing the fixation of the valve. The support layer 205 is made of a metal material.

The heart valve wire placing device rapidly punctures the valve on a single action point to form a buckle connection, the operation time is short, and the influence on the work of the valve is extremely small. At the same time, the wire 400 is connected to the first snap part 100, so that the anchored wire 400 is located on the atrial side of the valve, without affecting the operation of the valve and the chordae tendineae, and also facilitating the subsequent operation.

Referring to fig. 5(a), (b), (c), the wire connector 600 includes: a knot-line conduit 610; the knot line clamp 620 is arranged at the end part of the knot line guide pipe 610, and the knot line clamp 620 is a ring which is formed by high-memory steel sheets and automatically closes an opening; a conduit 630 at least partially threaded into the knot line conduit 610 and having an end pre-clipped into an opening of the knot line clip 620; a stopper 640 is provided on the knot line guide 610 next to the knot line clip 620. The thread tying device 600 enables the thread tying card 620 to automatically close to finish thread tying by withdrawing the thread pipe 630 pre-clamped in the opening of the thread tying card 620.

Referring to fig. 6(a), (b), (c), the wire cutter 700 includes a wire cutting guide 710; a scissors 720 disposed at an end of the trimming guide 710; and a power transmission member 730. The scissors 720 include two blades 721 connected to the power transmission unit 730, and a shear plate 723 connected to the blade 721 through an elastic connector 722 and vertically disposed to the blade 721, the elastic connector 722 is a spring, the blade 721 is arranged parallel to the axis of the trimming guide tube 710, the resilient connector 722 keeps the blade 721 clear of the shear plate 723, two spirally extending wire grooves 724 are correspondingly arranged on the side wall of the end part of the trimming guide pipe 710, the wireway 724 can guide the wire into the gap between the blade 721 and shear plate 723, so that two wires can be simultaneously guided in the cutting wire guide 710, the power transmission member 730 drives the blade 721 to move and perform a cutting operation on the cutting plate 723, and the elastic connection member 722 allows the blade 721 to automatically rebound to an initial position after the power transmission member 730 is released.

Referring to fig. 7, the apparatus treats mitral insufficiency by:

the guide wire is arranged through the femoral vein and the right atrium atrial septum, after the guide wire is arranged, the guide wire is guided into the heart valve wire placing device through the femoral vein, the operation section 320 is pushed to the mitral valve by means of the developing marker, the first end of the first thread is fixed on the first heart valve by the heart valve wire placing device, and the first end of the second thread is fixed on the second heart valve.

Referring to fig. 8(a), (b), (c), the second end of the first thread and the second end of the second thread are knotted between the first thread and the second thread using the knot device 600, thereby creating traction between the first heart valve and the second heart valve, reducing the gap between the first heart valve and the second heart valve, the thread is cut using the thread cutter 700, and the thread cutter and the cut thread are withdrawn. Fig. 8(a) shows the mitral valve which is not fully closed, and fig. 8(b) and (c) show the mitral valve which is completely closed after treatment, and the skilled person can adopt the cross-knotted rope traction among a plurality of snap connectors to achieve better treatment effect.

In connection with the specific case of mitral insufficiency, different knotted-string traction patterns can be chosen, and fig. 9(a) and (b) show another example of reducing the valve gap by securing two snap-on connectors on the same valve, so that two strings pull on the incompetent valve.

Example 2 [ jugular vein- -right atrium- -tricuspid valve ]

The present embodiments provide an apparatus for treating tricuspid insufficiency that includes a heart valve applier, a knot and a wire cutter. The heart valve wire applier, wire binder, and wire cutter are configured as in example 1, except that the catheter is shorter as in example 2.

Fig. 10(a) shows a tricuspid valve that is not totally closed, treated as follows:

and arranging a guide wire through jugular vein puncture, guiding the guide wire into the heart valve wire placing device through the jugular vein, pushing the operation section to the tricuspid valve by means of a developing indication mark, fixing the first end of the first wire on the first heart valve by adopting the heart valve wire placing device, and fixing the first end of the second wire on the second heart valve.

Referring to fig. 10(b), forming a knot between the first and second threads using the knot device to form a second end of the first and second threads, thereby creating a drag between the first and second heart valves to reduce a gap between the first and second heart valves, cutting the threads using the scissor device, withdrawing the scissor device and the cut threads.

Referring to fig. 10(c), optionally, a first end of a third thread may be fixed to a third heart valve opposite to the first heart valve and the second heart valve, and the knot device may be used to form knots among the second ends of the first thread, the second thread, and the third thread, so as to draw the incompetent valve and reduce the valve gap.

The above description is intended to be exemplary of the present disclosure, and not to limit the scope of the present disclosure, which is defined by the claims appended hereto.

Claims (19)

1. A heart valve wire applicator, comprising:

a guide pipe is arranged in the guide pipe,

a first buckle part is arranged on the base plate,

a second buckle part is arranged on the base plate,

a wire at least partially threaded through the conduit and fixedly connected to the first snap member,

a first power transmission member at least partially disposed through the conduit, the first power transmission member being disengageably connectable with the first catch member;

the catheter comprises in sequence: an extension section and an operation section;

a first buckle component direction guider is arranged at the near end of the operation section, and a guide channel for the first power transmission component to pass through is arranged on the first buckle component direction guider;

a second snap member connector is provided on the operative section, the second snap member connector being rotatably connected at a distal end to the catheter;

a second power transfer component at least partially disposed through the conduit, the second power transfer component connected with the second snap component connector, the second snap component connector detachably connectable with the second snap component;

such that, when the second power transmission part applies an opening rotational power to the second catch part connector, the second catch part connector rotates and forms a fixed angle with the operating section, the direction of the guide channel being directed towards the second catch part, when the first power transmission part applies an advancing power to the first catch part, the first catch part forms a catch connection with the second catch part.

2. The heart valve wire applier of claim 1, wherein said first snap feature is a snap feature and said second snap feature is a snap feature; or, the first buckle part is a clamping part, and the second buckle part is a buckle part.

3. The heart valve wire introducer of claim 1, wherein the first snap member direction guide is one or more metal tubes fixedly arranged on the catheter, and the inner part of the metal tubes is the guide channel.

4. The heart valve wire applier of claim 1, wherein the fixed angle is a right angle or an acute angle.

5. The heart valve wire applier of claim 1, wherein a distal end of said first power transmission member forms an external thread, a rear portion of said first snap member forms an internal thread, and said first power transmission member and said first snap member form a detachable connection via said internal and external threads.

6. A heart valve wire applier as claimed in claim 1 or 2 wherein said catheter is provided with a side opening at said operative section, said first snap member, said second snap member and said second snap member connector being provided at a side opening of said catheter.

7. The heart valve wire applier of claim 1, wherein the catheter tube is provided with a shaft at a distal end of the operative section, and a shaft hole is provided on the second snap member connector, the second snap member connector being rotatably connected to the catheter tube by the shaft and shaft hole.

8. The heart valve wire applier of claim 1, wherein the first power transmission member comprises a high memory steel wire.

9. The heart valve wire applier of claim 1, wherein the second snap member snaps over an end of the second snap member connector.

10. The heart valve wire placing device of claim 2, wherein the clamping member has an annular through hole for the buckle member to pass through and a clamping tongue arranged in the annular through hole, the clamping tongue is an elastic member with certain flexibility, the buckle member has a sharp head capable of passing through the annular through hole, and an extension part connected with the sharp head and provided with at least one clamping groove, and when the sharp head passes through the annular through hole, the clamping tongue is pressed against the clamping groove to form a clamping connection.

11. The heart valve wire applier of claim 10, wherein said clasp member further has a tail portion connected to said extension portion.

12. The heart valve wire applier of claim 11, wherein a distance between said tail of said catch member and said catch member is 0.5mm to 2mm after said first catch member and said second catch member form a catch connection.

13. The heart valve wire applier of claim 10, wherein said clip member has a protection portion corresponding to the sharp head of the clip member, said protection portion being externally rounded.

14. A heart valve wire introducer as claimed in claim 1, wherein a visualization marker is provided on at least one of the components or on the distal end of the catheter.

15. The heart valve wire applier of claim 11, wherein the tail portion of the clasp member and the clip member each independently comprise at least two layers: a support layer to provide structural support, and a biocompatible layer to provide biocompatibility.

16. The heart valve wire applier of claim 15, wherein said support layer has a plurality of sharp protrusions extending toward said biocompatible layer.

17. The heart valve wire applier of claim 1, wherein the fixed angle is 90 degrees.

18. The heart valve wire applier of claim 1, wherein the fixed angle is 20 to 60 degrees.

19. The heart valve wire applier of claim 1, wherein the fixed angle is 30 to 50 degrees.

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