A stable and detachable replacement system

Abstract

The present application relates to the field of medical devices, and specifically to a stably detachable replacement system, including a valve stent and a delivery system, wherein the valve stent is provided with a leaflet clamp and an anchoring ring, the delivery system includes an outer sheath, an inner core tube, a guide wire, and a disassembly connection mechanism, the disassembly connection mechanism includes a guide head, a connector, an elastic member, and a limit card, the guide head is provided with a positioning groove and a limit groove, the guide head is connected to the connector, one end of the limit card is fixed to the connector, and the other end is in the limit groove, when pre-installed, the guide head is tightly attached to the connector, the guide wire passes through the limit card so that one end of the limit card cooperates with the limit groove to achieve positioning and fixation, and one end of the leaflet clamp is set in the positioning groove, when the guide wire is pulled out of the limit card, the cooperation between the limit card and the limit groove fails, so that the guide head is separated from the connector, and one end of the leaflet clamp is detached from the positioning groove; the disassembly connection structure of the present application scheme is very stable, easy to operate, and has good clinical significance.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a stably detachable replacement system. Background Art

[0002] From a cardiac perspective, both the mitral and tricuspid valves possess unique physiological structures, making accurate positioning and fixation of the product extremely difficult. The mitral valve's location within the heart and its complex anatomical structure pose significant challenges for mitral valve replacement.

[0003] The existing patent CN202211180680.0 discloses a replacement system that can avoid outflow tract obstruction, including: a valve stent, a valve clamping and fixing device that cooperates with the valve stent, the valve clamping and fixing device is constructed as a valve clamping mechanism and a clamping member for clamping the autologous valve leaflets, and the clamping member is at least partially configured on the valve clamping mechanism. After the valve stent is installed in place, the clamping member drives the autologous valve leaflets to shift upward and tighten the valve stent; the valve clamping mechanism includes a clamping arm, a control rod and a control wire, wherein the clamping arm includes a fixed arm and a capture arm, the capture arm is hinged on the fixed arm, the control rod is detachably connected to the capture arm through the control wire, and pulling back / pushing the control rod can cause the capture arm to open / or close. Although this technical solution can prevent the anterior leaflet from blocking the left ventricular outflow tract, the detachable connection structure between the leaflet clamping arm and the distal end of the delivery system is controlled by only one control wire. In actual use, the control wire may be deformed, making it difficult to pull out the control wire during disassembly.

[0004] In summary, although the above technologies have achieved some clinical results, they all have shortcomings. A new transcatheter heart valve replacement system is urgently needed to solve the above problems. Summary of the Invention

[0005] In view of the above and other concepts, this application is proposed. The main purpose of this application is to overcome some problems and shortcomings of the prior art.

[0006] In terms of application in atrioventricular valve surgery, the present application aims to provide a stably detachable replacement system for patients with atrioventricular valve lesions who require interventional treatment, thereby solving the problem in the prior art of stably detachable clamping arms and delivery systems of heart valve replacement systems.

[0007] According to one aspect of the present application, a stably detachable replacement system is provided, comprising a valve stent, a delivery system for delivering the valve stent, the valve stent being provided with a leaflet clamp and an anchoring ring connected to the leaflet clamp, the delivery system comprising an outer sheath, an inner core tube arranged in the outer sheath and hollow inside, a guide wire arranged inside the inner core tube, and a detachable connection mechanism arranged at the distal end of the inner core tube, wherein the detachable connection mechanism comprises a guide head, a connector, an elastic member and a limiting card, the guide head being provided with a positioning groove and a limiting groove, the guide head being connected to the elastic member through the guide wire. The movable part is connected with the connecting part, one end of the limiting clamp is fixed with the connecting part, and the other end of the limiting clamp is arranged in the limiting groove. During pre-installation, the guide head is tightly attached to the connecting part, and the guide wire passes through the limiting clamp so that one end of the limiting clamp cooperates with the limiting groove to achieve positioning and fixation. One end of the leaflet clamp is arranged in the positioning groove, and when the guide wire is pulled out of the limiting clamp, the cooperation between the limiting clamp and the limiting groove fails, so that the guide head is separated from the connecting part, and one end of the leaflet clamp is detached from the positioning groove.

[0008] As a further improvement of the present invention, the guide wire is pulled out from the guide head and the connecting piece, and the part of the limit clamp set on the guide head shrinks inward, so that the clamping fixation of the limit clamp and the limit groove fails, and further the pre-tightened elastic piece pushes the guide head outward, so that the guide head is separated from the connecting piece, and further one end of the leaflet clamp is disengaged from the positioning groove, finally realizing the controllable release of the leaflet clamp and the distal end of the valve stent.

[0009] As a further improvement of the present invention, the limit clamp includes at least two limit rods. When the guide wire passes through the limit clamp, the limit rods are fixedly matched with the limit, so that the guide head and the connecting member are in close contact with each other.

[0010] As a further improvement of the present invention, the limit rod is evenly distributed along the circumference, wherein, in a natural state, the limit rod does not cooperate with the limit groove to be locked, and when the guide wire passes through the limit clamp, the limit rod is stretched open by the guide wire so that the limit rod and the limit groove are locked and fixed.

[0011] As a further improvement of the present invention, the number of the limiting rods is four, and in a natural state, the diameter of the circle formed by the four limiting rods is smaller than the diameter of the limiting groove.

[0012] As a further improvement of the present invention, a limiting protrusion is provided at one end of the limiting rod, wherein, in a natural state, the limiting protrusion is not in the limiting groove, and when the guide wire passes through the limiting clamp, the limiting rod is stretched open by the guide wire so that the limiting protrusion is located in the limiting groove.

[0013] As a further improvement of the present invention, in a natural state, the connector and the guide head are in a separated state, and the distance between the connector and the guide head is greater than the length of the leaflet clamp in the positioning groove.

[0014] As a further improvement of the present invention, the limit clamp is made of memory metal material.

[0015] As a further improvement of the present invention, during pre-installation, one end of the leaflet clamp is compressed into the positioning groove, so that the distal end of the valve stent can be controllably released through the guide wire.

[0016] As a further improvement of the present invention, the guide head is provided with a guide cavity, the connecting member is provided with a connecting cavity corresponding to the guide cavity, and both ends of the elastic member are respectively fixed in the guide cavity and the connecting cavity.

[0017] As a further improvement of the present invention, the disassembly connection mechanism further includes a guide column, one end of which is fixed in the connection cavity, and the other end of which is partially disposed in the guide cavity.

[0018] As a further improvement of the present invention, the elastic member is a spring, and the spring is sleeved on the guide post.

[0019] As a further improvement of the present invention, a connecting groove is provided on the connecting member, and during pre-assembly, one end of the leaflet clamping member is arranged at the connecting groove.

[0020] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following:

[0021] 1. In the existing replacement system, when the wire for controlling disassembly is pulled out, the force is concentrated at the connection point, causing the disassembly wire to deform, and the resistance during withdrawal increases, resulting in instability when the valve stent and the delivery system are disassembled and separated. In one embodiment of the present application, a guide wire is used to open the limit clamp so that the limit clamp can be fixed in the limit groove. At this time, the elastic member is in a pre-tightened state, and the guide head is tightly attached to the connector. One end of the valve stent is restricted in the positioning groove of the connector. When the valve stent needs to be separated from the delivery system, The operator only needs to pull the guide wire backward. After the guide wire leaves the guide head and the connector, the part of the limit card located on the guide head shrinks inward, making the position fixation of the limit card and the limit groove invalid, and further making the pre-tightened elastic part push the guide head outward, so that the guide head and the connector are separated, and further making one end of the leaflet clamp detach from the positioning groove, finally realizing the controlled release of the leaflet clamp and the distal end of the valve stent. The operation is very convenient, and the disassembly connection structure is very stable, which has great clinical significance.

[0022] 2. In one embodiment of the present application, the guidewire is used to guide the delivery system into the blood vessel and is also used as a controllable detachable component between the distal part of the valve stent and the delivery system. This eliminates the need for redundant control components in the delivery system and can significantly save space inside the delivery system.

[0023] The embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. These other technical effects may be partially described below and can be anticipated and understood by those skilled in the art after reading this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The above features and advantages of these embodiments and other features and advantages and the manner in which they are achieved will become more apparent, and the embodiments of the present application may be better understood, by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0025] Figure 1 Schematic diagram of the overall structure of the replacement system of the present invention.

[0026] Figure 2 It is a schematic cross-sectional structural diagram of the replacement system of the present invention.

[0027] Figure 3 This is another cross-sectional structural diagram of the replacement system of the present invention.

[0028] Figure 4 and Figure 5 This is a schematic diagram of the separation of the guide head 31, the connector 32 and the leaflet clamp after the guide wire is withdrawn.

[0029] Figure 6 Schematic diagram of the seeker structure.

[0030] Figure 7 Schematic diagram of the connector structure.

[0031] Figure 8 and Figure 9 Schematic diagram of the valve stent structure.

[0032] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-valve stent, 11-leaflet clamping part, 12-anchoring ring, 13-stent body, 14-artificial valve leaflet, 15-sealing ring, 2-delivery system, 21-outer sheath, 22-inner core tube, 23-guide wire, 3-disassembly connection mechanism, 31-guide head, 311-positioning groove, 312-limiting groove, 313-guide cavity, 32-connecting part, 321-connecting cavity, 322-connecting groove, 33-elastic part, 34-limiting card, 341-limiting rod, 342-limiting protrusion, 35-guide column. Implementation Method

[0033] In the following description of the drawings and specific embodiments, details of one or more embodiments of the present application will be described. Other features, purposes and advantages of the present application will be clear from these descriptions, drawings and claims.

[0034] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or executed in various ways. Each example is provided in an explanation of the disclosed embodiments, not in a limiting manner. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments of the present application without departing from the scope or essence of the disclosure of the present application. For example, a feature illustrated or described as part of one embodiment may be used in conjunction with another embodiment to still produce another embodiment. Therefore, the present application discloses such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0035] Likewise, it is understood that the phrases and terms used herein are for descriptive purposes only and should not be considered restrictive. The use of "include," "comprising," or "having" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents, as well as possible additional items.

[0036] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the application.

[0037] In this application, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator. Specific embodiments Example

[0038] like Figure 1 As shown, when the valve prosthesis is used for mitral valve treatment, a stably detachable replacement system includes a valve stent 1, a delivery system 2 for delivering the valve stent 1, the valve stent 1 is provided with a leaflet clamp 11, and an anchoring ring 12 connected to the leaflet clamp 11, the delivery system 2 includes an outer sheath 21, an inner core tube 22 which is arranged in the outer sheath 21 and is hollow inside, a guide wire 23 arranged in the inner core tube 22, and a detachable connection mechanism 3 arranged at the distal end of the inner core tube 22, wherein the detachable connection mechanism 3 includes a guide head 31, a connecting member 32, an elastic member 33 and a limiting clamp 34, as shown in FIG. Figure 2 and 7 As shown, the guide head 31 is provided with a positioning groove 311 and a limiting groove 312. Figure 6 As shown, the guide head 31 is connected to the connecting member 32 through the elastic member 33, one end of the limiting clamp 34 is fixed to the connecting member 32, and the other end of the limiting clamp 34 is set in the limiting groove 312. When pre-installed, the guide head 31 is tightly attached to the connecting member 32, and the guide wire 23 passes through the limiting clamp 34 so that one end of the limiting clamp 34 cooperates with the limiting groove 312 to achieve positioning and fixation. One end of the leaflet clamp 11 is set in the positioning groove 311, as shown in FIG. Figure 2 and 3 As shown, when the guide wire 23 is pulled out of the limiting clamp 34, the limiting clamp 34 fails to cooperate with the limiting groove 312, so that the guide head 31 is separated from the connecting member 32, and one end of the leaflet clamp 11 is disengaged from the positioning groove 311, as shown in FIG. Figure 4 and Figure 5 shown.

[0039] In this embodiment, when pre-installed, the guide head 31 is in close contact with the connecting member 32, and the elastic member 33 is in a pre-tightened state. In addition, the guide wire 23 passes through the connecting member 32, the limiting clamp 34 and the guide head 31, so that the guide wire 23 can stretch the portion of the limiting clamp 34 located at the guide head 31, and further enable the limiting clamp 34 to cooperate with the limiting groove 312 to achieve fixed position, such as Figure 2 As shown, at the same time, the guide wire 23 also serves as a guide for the delivery system 2 to enter the blood vessel.

[0040] In this embodiment, when the guide wire 23 is pulled out from the guide head 31 and the connector 32, the portion of the limit clamp 34 provided on the guide head 31 shrinks inward, causing the position fixation between the limit clamp 34 and the limit groove 312 to fail. Figure 4As shown, the pre-tightened elastic member 33 is further pushed outward to push the guide head 31, so that the guide head 31 is separated from the connecting member 32, and further one end of the leaflet clamping member 11 is disengaged from the positioning groove 311, as shown. Figure 5 As shown, the controllable release of the leaflet clamp 11 and the distal end of the valve stent 1 is finally achieved.

[0041] In this embodiment, the limiting clamp 34 includes at least two limiting rods 341. When the guide wire 23 passes through the limiting clamp 34, the limiting rods 341 are fixed with the limiting member so that the guide head 31 and the connecting member 32 are tightly attached to each other.

[0042] In this embodiment, the limiting rod 341 is evenly distributed along the circumference, wherein, in a natural state, the limiting rod 341 does not cooperate with the limiting groove 312 to be locked, and when the guide wire 23 passes through the limiting clamp 34, the limiting rod 341 is stretched open by the guide wire 23 so that the limiting rod 341 and the limiting groove 312 are locked and fixed.

[0043] In this embodiment, the number of the limiting rods 341 is four, and in a natural state, the diameter of the circle formed by the four limiting rods 341 is smaller than the diameter of the limiting groove 312. Figure 7 shown.

[0044] In this embodiment, a limiting protrusion 342 is provided at one end of the limiting rod 341, wherein, in a natural state, the limiting protrusion 342 is not in the limiting groove 312, and when the guide wire 23 passes through the limiting clamp 34, the limiting rod 341 is stretched open by the guide wire 23 so that the limiting protrusion 342 is located in the limiting groove 312.

[0045] In this embodiment, in a natural state, the connector and the guide head 31 are in a separated state, and the distance between the connector 32 and the guide head 31 is greater than the length of the leaflet clamp 11 in the positioning groove 311 .

[0046] In this embodiment, the limiting clamp 34 is made of memory metal material, for example, nickel-titanium alloy material.

[0047] In this embodiment, during pre-installation, one end of the leaflet clamp 11 is compressed into the positioning groove 311 , so that the distal end of the valve stent 1 can be controllably released through the guide wire 23 .

[0048] In this embodiment, the guide head 31 is provided with a guide cavity 313, the connecting member 32 is provided with a connecting cavity 321 corresponding to the guide cavity 313, and the two ends of the elastic member 33 are respectively fixed in the guide cavity 313 and the connecting cavity 321. Figure 2 shown.

[0049] In this embodiment, the detachable connection mechanism 3 further includes a guide post 35 , one end of which is fixed in the connection cavity 321 , and the other end of which is partially disposed in the guide cavity 313 .

[0050] In this embodiment, the elastic member 33 is a spring, and the spring is sleeved on the guide post 35 . The guide post 35 can define the movement path of the guide head 31 after being pushed open by the elastic member 33 .

[0051] In this embodiment, the connecting member 32 is provided with a connecting groove 322. Figure 7 As shown, during pre-assembly, one end of the leaflet clamping member 11 is arranged at the connecting groove 322, as shown in FIG. Figure 3 As shown, the structure of the connecting groove 322 is configured to adapt to the structure of the distal portion of the leaflet clamp 11, so that the valve stent 1 and the leaflet clamp 11 will not occupy excess sheath space when pre-installed.

[0052] In this embodiment, the valve stent 1 includes a stent body 13, an artificial valve arranged in the stent body 13, and a sealing ring 15 arranged at the proximal end of the stent body 13. The stent body 13 is a grid-shaped stent. Figure 8 and 9 shown.

[0053] In this embodiment, the artificial valve can be made of biological materials such as bovine pericardium, porcine pericardium, etc., and can also be made of polymer materials.

[0054] The foregoing description of exemplary embodiments of the present application has been presented for purposes of illustration. It is not intended to be exhaustive or to limit the present application to the precise configurations and / or constructions disclosed, and it is apparent that numerous modifications and variations may be made by those skilled in the art in light of the above teachings without departing from the present invention. It is intended that the scope and full range of equivalents of the present invention be defined by the claims appended hereto.

Claims

1. A stably detachable replacement system comprising a valve stent and a delivery system for delivering the valve stent, wherein the valve stent is provided with a leaflet holder and an anchoring ring connected to the leaflet holder, characterized in that: The conveying system includes an outer sheath tube, an inner core tube arranged in the outer sheath tube and hollow inside, a guide wire arranged in the inner core tube, and a disassembly connection mechanism arranged at the distal end of the inner core tube, wherein the disassembly connection mechanism includes a guide head, a connector, an elastic member and a limit clamp, the guide head is provided with a positioning groove and a limit groove, the guide head is connected to the connector through the elastic member, one end of the limit clamp is fixed to the connector, and the other end of the limit clamp is arranged in the limit groove. During pre-installation, the guide head is tightly attached to the connector, the guide wire passes through the limit clamp so that one end of the limit clamp cooperates with the limit groove to achieve positioning and fixation, one end of the leaflet clamp is arranged in the positioning groove, and when the guide wire is pulled out of the limit clamp, the cooperation between the limit clamp and the limit groove fails, so that the guide head is separated from the connector, and one end of the leaflet clamp is detached from the positioning groove.

2. The stably detachable replacement system according to claim 1, characterized in that: The limiting clamp includes at least two limiting rods. When the guide wire passes through the limiting clamp, the limiting rods are fixedly matched with the limiting rods so that the guide head and the connecting member are in close contact with each other.

3. The stably detachable replacement system according to claim 2, characterized in that: The limiting rods are evenly distributed along the circumference, wherein, in a natural state, the limiting rods do not cooperate with the limiting grooves to be locked, and when the guide wire passes through the limiting clamp, the limiting rods are stretched open by the guide wire so that the limiting rods and the limiting grooves are locked and fixed.

4. The stably detachable replacement system according to claim 3, characterized in that: A limiting protrusion is provided at one end of the limiting rod, wherein, in a natural state, the limiting protrusion is not in the limiting groove, and when the guide wire passes through the limiting clamp, the limiting rod is stretched open by the guide wire so that the limiting protrusion is located in the limiting groove.

5. The stably detachable replacement system according to claim 2, characterized in that: In a natural state, the connecting member and the guide head are in a separated state, and a distance between the connecting member and the guide head is greater than a length of the leaflet clamping member in the positioning groove.

6. The stably detachable replacement system according to claim 2, characterized in that: The limit clamp is made of memory metal material.

7. The stably detachable replacement system according to claim 2, characterized in that: During pre-installation, one end of the leaflet clamp is compressed into the positioning groove, so that the distal end of the valve stent can be controllably released through the guide wire.

8. The stably detachable replacement system according to claim 2, characterized in that: The guide head is provided with a guide cavity, the connecting piece is provided with a connecting cavity corresponding to the guide cavity, and two ends of the elastic piece are respectively fixed in the guide cavity and the connecting cavity.

9. The stably detachable replacement system according to claim 8, characterized in that: The disassembly connection mechanism further includes a guide post, one end of which is fixed in the connection cavity, and the other end of which is partially disposed in the guide cavity.

10. The stably detachable replacement system according to claim 9, characterized in that: The elastic member is a spring, and the spring is sleeved on the guide post.

11. The stably detachable replacement system according to claim 1, characterized in that: The connecting piece is provided with a connecting groove, and during pre-assembly, one end of the leaflet clamping piece is arranged at the connecting groove.

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