CN215458986U

CN215458986U - Interventional annuloplasty ring device

Info

Publication number: CN215458986U
Application number: CN202121199832.2U
Authority: CN
Inventors: 李建文; 杨亮; 李峰
Original assignee: Shanghai Yuban Medical Technology Co ltd
Current assignee: Shanghai Yuban Medical Technology Co ltd
Priority date: 2021-05-31
Filing date: 2021-05-31
Publication date: 2022-01-11
Anticipated expiration: 2031-05-31

Abstract

The utility model belongs to the technical field of medical instruments, and particularly relates to an interventional annuloplasty ring device. The device comprises a main body lantern ring, wherein the main body lantern ring is arranged into a flexible hollow sleeve with a closed distal end and an open proximal end; the contraction spring is made of a shape memory alloy material, and the memory shape of the contraction spring is a C shape which is curled to one side; the contraction spring is arranged in the main body lantern ring, the spiral central axis of the contraction spring is overlapped with the central axis of the main body lantern ring, and the contraction spring is fixedly arranged with the main body lantern ring. For reducing the size of the mitral annulus and improving the coaptation function of the mitral leaflets. The main body lantern ring is fixed with the mitral valve tissue through the anchor, the main body lantern ring is contracted in length through a contraction spring made of shape memory alloy materials, and the main body lantern ring is matched with the anchor to be folded to the size of the mitral valve annulus and to be in a special C-shaped shape, so that the purpose of improving the joint function of the mitral valve leaflets is achieved.

Description

Interventional annuloplasty ring device

Technical Field

The utility model belongs to the technical field of medical instruments, and particularly relates to an interventional annuloplasty ring device.

Background

The minimally invasive interventional medical technology is an efficient diagnosis and treatment method which is gradually developed in recent years, has the outstanding advantages of small wound, simple and convenient operation, accurate interventional part, few complications and the like, and is one of the most important diagnosis and treatment means for cardiovascular diseases and tumor diseases. In interventional medical surgery, a professional doctor usually needs to manually operate a specific device to enable one or more slender flexible catheters with different shapes or functions to pass through the complicated and changeable human body cavity environments of patients, such as cardiovascular and the like, and send instruments, such as catheters, guide wires, stents and the like, to preset pathological change positions for minimally invasive diagnosis and treatment.

The incidence of mitral valve disease is high among adult heart valve disease. Mitral Regurgitation (MR) in mitral valve disease is a serious concern for patients, and normally the mitral valve in the human heart acts as a hemostatic valve to prevent the backflow of oxygen-enriched blood from the lungs into the left atrium, and MR is generated once the mitral valve is improperly closed or misaligned, which can significantly reduce the pumping efficiency of the heart and even cause heart failure. Mitral regurgitation is divided into both functional and degenerative, and Functional Mitral Regurgitation (FMR) is characterized by mitral annulus dilation, inadequate leaflet coaptation, and mitral leaflet tethering, which are caused by left ventricular dysfunction and remodeling. Driven by the poor results and high risk of surgical mitral valvuloplasty, alternatives to catheter and minimally invasive approaches, such as percutaneous limbal repair, indirect annuloplasty, direct annuloplasty, and the like, have been sought. Mitral annuloplasty is one of the most common surgical procedures for treating FMR.

The Cardioband system (Edwards Lifescience, Irvine, USA) is a percutaneously adjustable surgical direct annuloplasty device. The device is implanted on the annulus of the heart valve through the interatrial septum using a transfemoral approach to achieve a reduced annulus size of the mitral valve and to improve the coaptation function of the leaflets of the mitral valve. Up to now, more than 400 FMR patients have been implanted with Cardioband. The Cardioband delivery system replicates to a high degree surgical annuloplasty and consists of three parts, (1) an implant delivery system with multi-layer, multi-directional bending; (2) an anchor drive operable to impart a one-to-one torque transmission to the anchor; (3) the inner forming ring tightening device and the wire-rewinding mechanism of the implant provide uniform gradual tightening. Cardioband uses a delivery sheath to deliver a plurality of anchors and precisely screw into a specific location, thereby securing the polymeric annuloplasty ring around the valve. The utility model provides a prosthetic annuloplasty ring device with a shape memory alloy contraction spring fixed in a main lantern ring.

SUMMERY OF THE UTILITY MODEL

In view of the above, the present invention provides an interventional annuloplasty ring device comprising

A main body collar configured as a flexible hollow sleeve with a distal end closing a proximal end opening;

the contraction spring is made of a shape memory alloy material, and the memory shape of the contraction spring is a C shape which is curled to one side;

the contraction spring is arranged in the main body lantern ring, the spiral central axis of the contraction spring is overlapped with the central axis of the main body lantern ring, and the contraction spring is fixedly arranged with the main body lantern ring.

As a preferred technical scheme, the improved nail comprises an anchor and a main body, wherein the anchor comprises an anchor body and an anchor cap, and the anchor body is arranged through the side wall of the main body lantern ring; the nail cap is arranged inside the cavity of the lantern ring of the main body.

As a preferred technical solution, the shank is provided with a helical structure, and the direction of the anchor in the body loop is: the spiral central axis of the nail body is perpendicular to the plane of the C-shaped central axis of the retraction spring.

As a preferable technical scheme, two pull rings are arranged on the side wall of one end of the opening of the main body sleeve ring, and the central hole of each pull ring is arranged outside the surface of the main body sleeve in a protruding mode.

As a preferable technical solution, the two pull rings are arranged in a central symmetry manner with respect to a circle center of the cross section of the main body lantern ring.

As a preferable technical solution, the pull-wire further comprises a pull wire, wherein the pull wire comprises two movable ends, the pull wire passes through the pull ring, and the two movable ends of the pull wire extend towards the proximal end.

As a preferred technical solution, the support tube further comprises a support tube extending into the body collar cavity.

As a preferable technical solution, the delivery sheath is provided as a hollow rotary structure with openings at both ends, and the main body lantern ring is provided inside a cavity of the delivery sheath.

As a preferred technical scheme, the main body lantern ring is made of a high polymer material.

As a preferred technical scheme, the conveying sheath further comprises a cooling pipe, and the far end of the cooling pipe is arranged in the cavity of the conveying sheath.

Has the advantages that:

(1) the present invention provides an interventional annuloplasty ring device for use in corrective treatment procedures for mitral regurgitation, and in particular, for reducing the size of the mitral annulus and improving the coaptation function of the mitral leaflets. The main body lantern ring is fixed with the mitral valve tissue through the anchor, the main body lantern ring is contracted in length through a contraction spring made of shape memory alloy materials, and the main body lantern ring is matched with the anchor to be folded to the size of the mitral valve annulus and to be in a special C-shaped shape, so that the purpose of improving the joint function of the mitral valve leaflets is achieved.

(2) Compared with the mode that the pull wire penetrates through the anchor nail to be tensioned and contracted adopted by the existing contraction ring, the contraction spring made of the shape memory alloy material is adopted to provide the contraction function and the shape bending function for the main body lantern ring, so that more uniform contraction pull force can be provided, the tightening and pulling of the anchor nail on human tissue are uniformly distributed on each anchor nail, the condition that the stress of a specific anchor nail is overlarge is avoided, and the unnecessary damage to the human tissue is avoided.

(3) According to the utility model, the contraction spring made of the shape memory alloy material is adopted to provide the contraction function and the shape bending function for the main lantern ring, the contraction spring has the contraction function and the locking function, the self-locking assembly in the existing contraction ring is reduced, the simplification and the light weight of the completed medical instrument are realized, the cost of the treatment means and the burden of the body of a patient are reduced, the treatment cost and the operation risk of the mitral valve regurgitation disease are reduced, and the possibility is provided for the patient to be cured in a wider range.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic structural view of an interventional annuloplasty ring device according to the present invention;

FIG. 2 is a schematic structural view of the present interventional annuloplasty ring device during implantation;

FIG. 3 is a schematic structural view of the present interventional annuloplasty ring device during implantation;

FIG. 4 is a schematic structural diagram of a polymer bushing in a contracted state;

1-body lantern ring, 2-contraction spring, 3-anchor, 4-pull ring, 5-pull wire, 6-support tube and 7-delivery sheath.

Detailed Description

The utility model will be further understood by reference to the following detailed description of preferred embodiments of the utility model and the examples included therein.

When describing embodiments of the present application, the use of "preferred," "preferably," "more preferred," and the like, is meant to refer to embodiments of the utility model that may provide certain benefits, under certain circumstances. However, other embodiments may be preferred, under the same or other circumstances. In addition, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, nor is it intended to exclude other embodiments from the scope of the utility model.

In this document, relational terms such as first, second, and the like may be used solely to distinguish one entity from another entity without necessarily requiring or implying any actual such relationship or order between such entities. Furthermore, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a component, apparatus, or device that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such component, apparatus, or device.

When a component, element, or layer is referred to as being "on," "bonded to," "connected to," or "coupled to" another element or layer, it may be directly on, bonded to, connected to, or coupled to the other element, or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being "directly on," "directly coupled to," "directly connected to" or "directly coupled to" another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a similar manner (e.g., "between … …" versus "directly between … …," "adjacent" versus "directly adjacent," etc.).

As used herein, "proximal" refers to the end of the medical device that is closer to the clinician using the medical device; "distal" refers to the end of the medical device that is distal from the physician when using the medical device; the term conforms to the custom made in the medical device industry.

An interventional annuloplasty ring device, as illustrated in figures 1-4, comprising

The main body lantern ring 1 is arranged as a flexible hollow sleeve with a closed distal end and an open proximal end;

the contraction spring 2 is made of a shape memory alloy material, and the memory shape of the contraction spring 2 is a C shape which is curled to one side;

the contraction spring 2 is arranged inside the main body lantern ring 1, the spiral central axis of the contraction spring 2 is superposed with the central axis of the main body lantern ring 1, and the contraction spring 2 is fixedly arranged with the main body lantern ring 1.

In some preferred embodiments, the anchor further comprises an anchor 3, wherein the anchor 3 comprises a shank and a cap, and the shank is arranged through the side wall of the body loop 1; the nail cap is arranged inside the cavity of the main body lantern ring 1.

In some preferred embodiments, the shank is provided as a helical structure, and the orientation of the anchor 3 within the body loop 1 is: the spiral central axis of the nail body is perpendicular to the plane of the C-shaped central axis of the retraction spring 2.

In some preferred embodiments, two pull rings 4 are disposed on the side wall of the open end of the body collar 1, and the central hole of the pull ring 4 is protruded out of the surface of the body sleeve.

In some preferred embodiments, two of the pull rings 4 are arranged centrally symmetrically with respect to the center of the cross section of the body collar 1.

In some preferred embodiments, the pull ring further comprises a pull wire 5, wherein the pull wire 5 comprises two movable ends, the pull wire 5 passes through the pull ring 4, and the two movable ends of the pull wire 5 extend towards the proximal end.

The arrangement of the pull wire allows a user to pull one movable end of the pull wire outside the body of the patient to withdraw the pull wire out of the body, thereby facilitating the recovery of process functional parts by the user and reducing the number of components retained in the body.

In some preferred embodiments, a support tube 6 is further included, the support tube 6 extending into the body collar 1 cavity.

In some preferred embodiments, the delivery sheath 7 is provided as a hollow solid of revolution structure with both ends open, and the main body collar 1 is provided inside the cavity of the delivery sheath 7.

Preferably, the delivery sheath is provided with an outer surface which is smooth in surface, round in shape and free of protruding structures, and is used for conveying the polymer sleeve to a specified position while avoiding damage to blood vessels in the conveying process.

In some preferred embodiments, the main body collar 1 is made of a polymer material.

In some preferred embodiments, the device further comprises a cooling tube, and the distal end of the cooling tube is arranged in the cavity of the delivery sheath 7. The cooling pipe is used for continuously introducing cold air in the implantation process to keep the straight shape of the contraction spring, and after the implantation is finished, the introduction of the cold air is stopped, so that the contraction spring is fixed into a memory shape, namely, a C-shaped shape which is curled towards one side, the implantation of the main body lantern ring and the selection of the anchoring position of the anchor are facilitated, and the accuracy and the stability of the anchoring process are ensured.

The working principle is as follows: the body collar and internal retraction spring are loaded into the delivery sheath lumen and delivered to the body tissue surface. When the annular ring reaches a designated area, such as the back valve ring of a mitral valve, the main body lantern ring is pushed out of the delivery sheath by the support tube for a certain distance, the retractable spring fixed in the pushed-out part changes in shape and recovers the preset bent shape, and meanwhile, the outer layer main body lantern ring is driven to bend and deform, and at the moment, the anchor is screwed into the thread line of the retractable spring in the pushed-out part of the main body lantern ring, so that the effect of fixing the bent main body lantern ring with the valve ring is achieved. Then the supporting tube is withdrawn, the stay wire is tensioned, the next anchor is screwed in, and then the operations of pushing out the main body lantern ring and screwing in the anchor are sequentially carried out, and finally the uniform annular fixation of the whole main body lantern ring and the valve tissue is completed. After the last anchor is screwed into the mitral valve triangular fiber area, the shape memory alloy contraction spring can fix the annuloplasty ring of the main body lantern ring with valve tissue due to the designed short contraction size structure, and the effect of reducing the size of the valve ring is achieved.

Claims

1. An interventional annuloplasty ring device comprising

The main body lantern ring (1), the main body lantern ring (1) is set as a flexible hollow sleeve with a closed distal end and an open proximal end;

the contraction spring (2), the contraction spring (2) is made of shape memory alloy materials, and the memory shape of the contraction spring (2) is a C shape which is curled to one side;

the contraction spring (2) is arranged inside the main body lantern ring (1), the spiral central axis of the contraction spring (2) is superposed with the central axis of the main body lantern ring (1), and the contraction spring (2) is fixedly arranged with the main body lantern ring (1).

2. The interventional annuloplasty ring device according to claim 1, further comprising anchors (3), said anchors (3) comprising a shank and a cap, said shank being disposed through a sidewall of said body collar (1); the nail cap is arranged inside the cavity of the main body lantern ring (1).

3. The interventional annuloplasty ring device according to claim 2, characterized in that the shank is provided as a helical structure, the orientation of the anchors (3) within the body collar (1) being: the screw central axis of the nail body is perpendicular to the plane of the C-shaped central axis of the retraction spring (2).

4. The device of claim 1, wherein the body collar (1) is provided with two pull rings (4) on its open end side wall, the central hole of the pull ring (4) being arranged protruding out of the surface of the body collar.

5. The interventional annuloplasty ring device according to claim 4, characterized in that two of said pull rings (4) are arranged centrosymmetrically with respect to a circle center of the cross section of the body collar (1).

6. The interventional annuloplasty ring device according to claim 5, further comprising a pull wire (5), said pull wire (5) comprising two movable ends, said pull wire (5) passing through said pull ring (4), said two movable ends of said pull wire (5) extending proximally.

7. The interventional annuloplasty ring device according to claim 1, further comprising a support tube (6), said support tube (6) extending into the body collar (1) cavity.

8. The interventional annuloplasty ring device according to claim 1, further comprising a delivery sheath (7), said delivery sheath (7) being provided as a hollow solid of revolution structure open at both ends, said body collar (1) being provided inside a cavity of said delivery sheath (7).

9. The interventional annuloplasty ring device according to claim 1, characterized in that the main body collar (1) is made of a polymeric material.

10. The interventional annuloplasty ring device according to claim 8, further comprising a cooling tube, the cooling tube distal end being arranged within the lumen of the delivery sheath (7).