CN117338351A

CN117338351A - Plugging instrument

Info

Publication number: CN117338351A
Application number: CN202210751701.3A
Authority: CN
Inventors: 朱泽荀; 任凯炳; 姚瑶; 李俊菲
Original assignee: Minimally Invasive Investment Holdings Ltd
Current assignee: Minimally Invasive Investment Holdings Ltd
Priority date: 2022-06-28
Filing date: 2022-06-28
Publication date: 2024-01-05

Abstract

The invention relates to a plugging device, which is used for treating inter-chamber perforation and comprises a plugging net frame and a covering film, wherein the covering film covers at least part of the surface of the plugging net frame; the plugging net rack comprises two plugging discs which are oppositely arranged and a waist part which is connected with the two plugging discs; the waist is for accommodation in the inter-cell perforation; the two plugging discs are used for clamping cardiac muscle at two ends of the ventricular septum perforation along the axial direction in the unconstrained state; the two plugging discs comprise a plurality of stand bars which are independently arranged, and all stand bars in each plugging disc are sequentially arranged along the circumferential direction around the longitudinal axis of the plugging net frame. The invention can effectively reduce the damage to myocardial tissues, and has higher safety and more stable and reliable clamping.

Description

Plugging instrument

Technical Field

The invention relates to the technical field of medical instruments, in particular to a plugging instrument for treating inter-ventricular perforation.

Background

Post-myocardial infarction ventricular septal perforation (VSR) is a secondary ventricular septal defect caused by ischemia and rupture of the ventricular septum after acute myocardial infarction, is one of serious complications after Acute Myocardial Infarction (AMI), and accounts for about 0.2% -0.7% of patients with acute myocardial infarction. The incidence of this disease is greater in men than women and most occur after primary myocardial infarction. Once ventricular septum perforation occurs, it can lead to diversion of left to right blood, reduced blood volume in the systemic circulation, increased blood volume in the pulmonary circulation, hypotension, hypocenter syndrome, pulmonary edema, left/right heart insufficiency, oliguria, dyspnea, and even multiple organ failure in the patient. The prognosis of the inter-ventricular perforation is very poor, mortality is very high, mortality is 25% at 24 hours, 50% in one week, and mortality is as high as 80% in one month, with only 7% of patients being able to survive for more than one year.

Thus, treatment of ventricular septum perforation is critical. The composition is greatly different from congenital ventricular septal defects in terms of formation mechanism, pathophysiology and the like, so that the composition is also greatly different in treatment method. Current methods of treatment mainly include drug therapy, surgery and interventional therapy. Among them, medical drug treatment aims at improving symptoms and cardiac function, creating opportunities for further surgery or interventional therapy. Surgical treatment is performed by repairing inter-ventricular perforations of a patient by thoracotomy, but since inter-ventricular myocardial tissue is abnormally fragile at the beginning of perforation, the surgical operation usually requires waiting at least two weeks for the myocardial tissue to primarily heal to ensure suture strength. But this is disadvantageous in reducing patient pain and reducing patient mortality.

At present, in interventional occlusion treatment, the existing occluder is simply improved on the basis of the prior ventricular septal defect occluder, and the problems of easy damage to myocardial tissue at fragile ventricular septal perforation, residual shunt, unstable fixation and the like of the occluder still exist. Even with the use of dedicated occluders for ventricular septum perforation, these occluders have various problems such as susceptibility to damage to myocardial tissue, weak clamping force, limited treatment sites, influence on electrical signal transmission, and adverse endothelialization.

Disclosure of Invention

The invention aims to provide a plugging device which is suitable for ventricular septum perforation caused by plugging myocardial infarction and can solve at least one technical problem of the existing congenital ventricular septal defect plugging device or the special ventricular septum perforation plugging device.

To achieve the above object, the present invention provides an occlusion device for treating inter-ventricular perforation, comprising an occlusion net frame and a covering film covering at least a part of a surface of the occlusion net frame;

the plugging net rack comprises two plugging discs which are oppositely arranged and a waist part connected with the two second plugging discs; the waist for receipt in the inter-cell perforation; the two plugging discs are used for clamping cardiac muscle at two ends of the compartment perforation along the axial direction in the unconstrained state; both the plugging discs comprise a plurality of stand bars which are independently arranged, and all stand bars in each plugging disc are sequentially arranged along the circumferential direction around the longitudinal axis of the plugging net rack.

In one embodiment, when the plugging device is in the unconstrained state, the two plugging discs form a space in a direction away from each other, and all the supporting legs of each plugging disc can avoid diseased cardiac muscle around the ventricular septum perforation and can be clamped on healthy cardiac muscle.

In one embodiment, the leg has opposite fixed and free ends, the fixed end being connected to the waist, the free end being for abutment against healthy myocardium, and the width of the leg decreasing sequentially from the fixed end to the free end.

In one embodiment, the width of the leg is less than or equal to 2.0mm and/or the thickness of the leg is less than or equal to 0.6mm.

In one embodiment, the maximum diameter of at least one of the occlusion discs is 10mm to 20mm greater than the diameter of the inter-ventricular septum perforation when the occlusion device is in the unconstrained state.

In one embodiment, the legs have a lowest point and a highest point in the direction of the longitudinal axis of the occlusion net frame and the legs have a furthest point in the radial direction of the occlusion net frame when the occlusion device is in the unconstrained state; the furthest point is located between the highest point and the lowest point, or the distances from the lowest point and the furthest point to the highest point are equal.

In one embodiment, the vertical distance between the lowest point and the highest point is 1mm to 15mm.

In one embodiment, the vertical distance between the lowest point and the highest point is 2mm to 10mm.

In one embodiment, the perpendicular distance of the nadir to the longitudinal axis of the occlusion stent is greater than 3mm.

In one embodiment, the free ends of the legs are turned outwards and form an atraumatic surface.

In one embodiment, the minimum distance between two of the occlusion discs is less than or equal to the thickness of the compartment space when the occlusion device is in the unconstrained state.

In one embodiment, the waist portion is a deformable elastic structure.

In one embodiment, the waist has at least one of the following features:

the axial height of the waist is less than the chamber spacing thickness;

the waist has a diameter less than the diameter of the inter-cell perforation.

In one embodiment, the occlusion device has an axially through hollow passage allowing an external device to pass through the occlusion device, the hollow passage including a slot in the covering membrane and a lumen of the waist.

In one embodiment, a connection device is provided in the inner cavity of the waist for detachable connection with the delivery system.

In one embodiment, the connecting device and the waist are fixedly connected by at least two fixing pins, the at least two fixing pins are oppositely arranged in the radial direction of the waist, and the hollow channel is reserved between the two fixing pins oppositely arranged in the radial direction.

In an embodiment, the covering film is fixed on the plugging net frame in a sewing mode, the supporting legs are provided with through sewing holes and/or non-through sewing grooves, and the plugging net frame is bound and fixed with the covering film through the sewing holes and/or the sewing grooves.

Compared with the prior art, the plugging device provided by the invention comprises a plugging net rack and a covering film, wherein the covering film covers at least part of the surface of the plugging net rack; the plugging net rack comprises two plugging discs which are oppositely arranged and a waist part connected with the two plugging discs; the waist for receipt in the inter-cell perforation; the two plugging discs are used for clamping cardiac muscle at two ends of the compartment perforation along the axial direction in the unconstrained state; the two plugging discs comprise a plurality of stand bars which are independently arranged, and all stand bars in each plugging disc are sequentially arranged along the circumferential direction around the longitudinal axis of the plugging net rack; so configured, the invention has the following advantages:

(1) Because each plugging disc is composed of a plurality of independent supporting legs, the forming of the plugging disc after expansion is more stable, the inner side of the plugging disc is not easy to bulge and deform towards the inter-ventricular septum, and the risk of the inner side of the plugging disc being attached to fragile myocardial tissues on the inter-ventricular septum is reduced, so that the risk of damaging the fragile myocardial tissues is reduced;

(2) Because each plugging disc consists of a plurality of independent supporting legs, the surface area occupied by the metal material of the whole plugging net rack is small, so that metal ions such as nickel ions are less precipitated, endothelialization is facilitated, the risk of thrombosis is reduced, and complications are reduced;

(3) The contact area between each support leg and the room is small, so that the problems of nipple muscle compression, tendon damage, backflow, heart failure and the like are avoided, the safety of the plugging device is higher, the clamping force of the plugging disc with the support leg structure is stronger, the plugging device is not easy to shift, and the plugging performance is better;

(4) If the clamping force of the plugging instrument needs to be adjusted, the plugging instrument can be realized by simpler process means, such as adjusting the thickness and/or width of each supporting leg, adjusting the axial height of the waist and the like, thereby reducing the manufacturing difficulty, leading the plugging instrument to be capable of coping with the treatment requirements of various room-interval perforations and having wider application range;

(5) Because the contact area between the plugging disc and the room space is small, the treatment position of the plugging disc at the room space is not easily limited, plugging devices can be placed at more positions to treat various room space perforations, the use is more flexible and convenient, and the application range is wider; in particular, even if the occluding device is arranged at a critical location of the compartment space (the critical location is typically the location where the electrical signal is transmitted), the transmission of the electrical signal is less susceptible to the occluding device due to the small contact area, thereby reducing the risk of signal conduction block.

In the preferred scheme, after the plugging device expands at the ventricular septum, the two plugging discs form a space in a direction away from each other when the plugging device is in the unconstrained state, so that the contact point of each plugging disc and the ventricular septum can cross fragile lesion cardiac muscle at two sides of the ventricular septum perforation along the axial direction, and further the plugging discs at two ends of the ventricular septum perforation along the axial direction are clamped on healthy cardiac muscle tissues at the ventricular septum, and the secondary damage to the fragile cardiac muscle tissues is effectively reduced.

Drawings

In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic view of the overall structure of an occlusion device according to a preferred embodiment of the present invention;

FIG. 2 is a view of an application scenario of an occlusion device according to a preferred embodiment of the present invention, wherein the covering membrane is not shown;

FIG. 3 is a schematic view of the structure of a plugging grid in a plugging device according to a preferred embodiment of the invention;

FIG. 4 is a front view of a plugging grid according to a preferred embodiment of the present invention;

FIGS. 5 and 6 are schematic views of the dimensions of a plugging grid according to a preferred embodiment of the present invention;

FIG. 7 is a schematic view of a plugging grid frame according to a preferred embodiment of the present invention, wherein the plugging grid frame adopts a net-shaped framework as a waist;

FIG. 8 is a schematic view of a plugging grid frame with a spring structure as waist according to a preferred embodiment of the present invention;

FIG. 9 is a schematic cross-sectional view showing a waist portion having a connecting means embedded therein and fixed by a fixing pin according to a preferred embodiment of the present invention;

FIG. 10 is a schematic view of the overall structure of the waist portion with the connecting means embedded therein according to a preferred embodiment of the present invention;

FIG. 11 is a schematic top view of a slot in a cover film to allow external instruments to pass through in accordance with a preferred embodiment of the present invention;

FIG. 12 is a schematic view of an occlusion device having an axially through hollow passageway according to a preferred embodiment of the present invention;

FIG. 13 is a schematic view showing a partial structure of a support leg with suture holes for binding a covering film and plugging a net frame according to a preferred embodiment of the present invention;

fig. 14 is a schematic view showing a partial structure of a support leg provided with a suture groove for binding a covering film and a plugging grid according to a preferred embodiment of the present invention.

Reference numerals are described as follows:

100-plugging the instrument; 110-plugging the net rack; 111-supporting legs; 111 a-suture holes; 111 b-suture slots; 112-waist; 113-a first occlusion disk; 114-connecting means; 115-a second occlusion disk; 116-fixing pins; 120-suture; 130-coating; 131-groove; width of the W-leg; thickness of the T-leg; a-lowest point; b-highest point; c-the furthest point; h1-minimum height; h2-axial height of waist; h3-maximum height; d1—maximum diameter of the first occlusion disk; d2—maximum diameter of the second occlusion disk; d3-diameter of waist; d4—diameter of the compartment-spacing perforations; d-distance from the lowest point to the central axis of the plugging net rack; 200-cell-space perforations; 210-diseased myocardium; 230-healthy myocardium.

Detailed Description

To make the objects, advantages and features of the present invention more apparent, the present attack will be described in further detail below with reference to the accompanying drawings. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.

It should be understood that the structures, proportions, sizes, etc. shown in the drawings are for illustration purposes only and should not be construed as limiting the invention to the extent that it can be practiced, since modifications, changes in the proportions, or otherwise, used in the practice of the invention, are not intended to be critical to the essential characteristics of the invention, but are intended to fall within the spirit and scope of the invention. Also, the terms such as "upper," "lower," "left," "right," "middle," and "a" and the like recited in the present specification are merely for descriptive purposes and are not intended to limit the scope of the invention, but are intended to provide relative positional changes or modifications without materially altering the technical context in which the invention may be practiced.

Herein, "proximal" refers to the end of the occluding device that is proximal to the operator; "distal" refers to the end of the occluding device distal from the operator; "radial" means a direction perpendicular to the longitudinal axis (central axis) of the occluding device, i.e., perpendicular to the axial direction of the compartment-spacing perforations; "longitudinal" means a direction parallel to the longitudinal axis of the occluding device, i.e., parallel to the axial direction of the inter-cell perforation, where parallel includes coincidence; "circumferential" refers to a direction about the longitudinal axis of the occluding device. Herein, "inside the occluding device" refers to the side near the compartment space; "external to the occluding device" means the side remote from the compartment space; "occlusion device surface" refers to the exterior and/or interior surface of an occlusion device; "inside of the occluding device" refers to the side of the occluding device facing the compartment space. Herein, "unconstrained state" generally refers to the state of the occlusion device after expansion; "constrained state" generally refers to the delivery state of the occluding device within the catheter.

The invention aims to provide a plugging device for treating ventricular septal perforation, which is used for solving at least one technical problem of the prior congenital ventricular septal defect plugging device or the special ventricular septal perforation plugging device. The ventricular septal perforation to which the plugging device disclosed by the invention is applicable comprises ventricular septal perforation after myocardial infarction and congenital ventricular septal defect.

In the occlusion device disclosed herein, the occlusion device has a constrained state and an unconstrained state, and is switchable between the constrained state and the unconstrained state. The plugging device specifically comprises a plugging net frame and a covering film arranged on the plugging net frame, wherein the covering film covers at least part of the outer surface and/or at least part of the inner surface of the plugging net frame. The plugging net rack comprises two plugging discs which are oppositely arranged, and waists connected with the two plugging discs; the waist is for accommodation in the inter-cell perforation; two of the occlusion discs are used to hold the myocardium at both ends of the inter-ventricular septum in the axial direction in an unconstrained state. In one application scenario, one of the two occlusion discs is placed in the right ventricle and serves as a proximal occlusion disc, the other occlusion disc is placed in the left ventricle and serves as a distal occlusion disc, the proximal occlusion disc is located at the proximal end of the occlusion device, and the distal occlusion disc is located at the distal end of the occlusion device.

The technical solution proposed by the present invention is further described below with reference to the accompanying drawings and preferred embodiments, and the following embodiments and features in the embodiments may be mutually complemented or combined without conflict.

Fig. 1 is a schematic overall structure of a plugging apparatus 100 according to a preferred embodiment of the present invention, fig. 2 is an application scenario diagram of the plugging apparatus 100 according to a preferred embodiment of the present invention, fig. 3 is a schematic structural diagram of a plugging grid 110 according to a preferred embodiment of the present invention, and fig. 4 is a schematic front view structure of the plugging grid 110 according to a preferred embodiment of the present invention.

Referring to fig. 1-4, the occluding device 100 is adapted to treat the ventricular septum puncture 200, and the ventricular septum puncture 200 is not limited to the ventricular septum puncture caused after myocardial infarction. The plugging apparatus 100 is an integrated assembly structure, and includes a plugging grid 110 and a covering film 130. The cover 130 covers at least a portion of the surface of the occluding grid 110, such as at least a portion of the inner surface and/or at least a portion of the outer surface of the occluding grid 110. The inner surface is the side adjacent to the inter-cell perforations 200 and the outer surface is the side facing away from the inter-cell perforations 200. The function of the covering membrane 130 is to regulate the flow direction of the liquid inside and/or outside the plugging grid 110, further ensure the plugging performance, and also facilitate endothelialization after the covering membrane 130 and reduce the risk of thrombosis.

The plugging grid 110 comprises two plugging trays which are oppositely arranged, wherein the two plugging trays are a first plugging tray 113 and a second plugging tray 115, and the plugging grid 110 further comprises a waist 112 connected with the first plugging tray 113 and the second plugging tray 115. After being implanted into a human body, the waist 112 is configured to be received in the inter-ventricular septum 200, and the first blocking disc 113 and the second blocking disc 115 are respectively disposed at two axial ends of the inter-ventricular septum 200 to clamp the myocardium when in an unconstrained state, so as to further block the inter-ventricular septum 200, and simultaneously position and fix the blocking device 100, so that the blocking device 100 is more firmly fixed. The covering film 130 mainly covers the inner surface and/or the outer surface of the two plugging discs, and may further cover at least part of the outer surface of the waist portion 112.

Wherein the first and second sealing trays 113 and 115 each comprise a plurality of independently disposed legs 111, and all of the legs 111 in each sealing tray are disposed in sequence circumferentially about the longitudinal axis of the sealing grid 110 to form a generally umbrella or arch-shaped structure. One end (fixed end) of all the supporting legs 111 in each plugging tray is fixedly connected with the waist 112, and the other end is a free end. The legs 111 in each tray are independent of each other, and the legs 111 are preferably arranged circumferentially in sequence uniformly about the longitudinal axis of the rack 110. However, the present invention is not limited to the specific number of the legs 111 in each of the sealing discs, and the sealing discs may be constructed by selecting an appropriate number of the legs 111 according to the actual treatment situation.

When the device is configured, all the supporting legs 111 of each plugging disc are mutually independent and dispersed, so that the plugging disc formed by the supporting legs 111 can greatly reduce the contact area between the plugging device and the room space and reduce the damage to myocardial tissues, thereby avoiding the problems of pressing papillary muscles, damaging chordae tendineae, flowing backwards, even heart failure and the like, reducing the damage of the plugging device to the myocardial tissues and having better safety. Moreover, the mode of adopting independent stabilizer blade 111 to construct the shutoff dish makes the shaping after the shutoff dish expands more stable, and the inboard of shutoff dish is difficult for being out of shape towards the room interval direction protruding to further reduced the inboard of shutoff dish and the risk of the laminating of the fragile myocardial tissue on the room interval, thereby reduced the risk of damaging fragile myocardial tissue. In addition, the clamping force of the plugging disc constructed by the support legs 111 is stronger, the plugging instrument is not easy to shift, and the plugging performance is better. In addition, the provision of the legs 111 has the advantage of easy adjustment of the clamping force of the plugging device, so that the plugging device can cope with the treatment requirements of various inter-chamber perforations, and at this time, the plugging device can be realized by simpler process means, such as only adjusting the thickness and/or width of each leg, adjusting the axial height of the waist, and the like, and the process is simpler and the adjustment difficulty is reduced. Secondly, the outer surface of the plugging disc constructed by the support legs 111 is smoother and smoother, the surface area of the metal material is smaller, nickel ions are less precipitated, endothelialization is facilitated, the risk of thrombosis is reduced, and complications are reduced.

It will also be appreciated that the treatment sites of conventional ventricular septum perforation occluders are limited, and that critical sites on the ventricular septum, primarily critical sites for electrical signal transmission, are not available for placement of the occluder, otherwise would affect the normal transmission of electrical signals. The area of contact between each support leg 111 and the room space is very small, so that the treatment position of the plugging device on the room space is not easily limited, and the plugging device 100 can be placed at more treatment positions, thereby treating various room space perforation, and the plugging device is more flexible and convenient to use and wider in application range. It will be appreciated that even if the occluding device 100 is placed in a critical location within the ventricular septum, the normal transfer of electrical signals at that location will not be affected by the occluding disc due to the very small contact area between the occluding disc and the ventricular septum, effectively reducing the chance of electrical signal conduction block and ensuring proper cardiac function.

Further, in order that the point of contact of the occluding disc with the ventricular septum tissue may span the delicate diseased myocardium 210 around the ventricular septum penetration 200, the first occluding disc 113 and the second occluding disc 115 each form a space in a direction away from each other when the occluding device 100 is in an unconstrained state, the space of each of the occluding discs enabling all of the legs 111 of the occluding disc itself to effectively avoid the diseased myocardium 210 around the ventricular septum penetration 200 and clamp onto the healthy myocardium 230, thereby reducing the trauma to the delicate myocardial tissue by the occluding device 1100.

In the embodiment of the present invention, the plugging grid 110 may be integrally cut from a metal pipe, so as to obtain the first plugging tray 113, the second plugging tray 115 and the waist 112 which are integrally connected. Of course, the plugging net frame 110 is not limited to the integral cutting and manufacturing, and there is an embodiment in which each of the legs 111 is separately manufactured and then the legs 111 are fixedly connected with the waist 112. Thus, in addition to an integrated design, the occluding grid 110 may also be a split design, such as having one or both occluding plates formed in a split design with the waist 112. However, whether of an integrally formed design or a separately formed design, each leg 111 has opposite fixed and free ends, the fixed ends being connected to the waist 112 and the free ends being configured to abut the healthy myocardium 230 on the ventricular septum.

The material of the occlusion mesh 110 is preferably a superelastic material and/or a shape memory alloy material, including but not limited to nickel-titanium alloy. The legs 111 of the plugging rack 110 have a long bar-like structure, but the cross-sectional shape thereof may be various, including but not limited to rectangular, such as circular, oval, trapezoid, etc., and if trapezoidal, the width of the inner surface of the legs 111 is larger than the width of the outer surface. Wherein the cross-section defined by the width W and the thickness T of the leg 111 is the cross-section of the leg 111. Furthermore the length of the legs 111 in each tray may be equal or unequal.

Referring to fig. 3, the legs 111 may have the same or different widths W. Preferably, the widths W of the legs 111 are different, and the widths W of the legs 111 are sequentially reduced from the fixed end to the free end, so that the width W of the connection position of the legs 111 and the waist 112 is maximized, thereby ensuring the connection strength of the legs and the waist, enabling the legs to be difficult to break, simultaneously enabling the width W of the contact position between the legs 111 and the room space to be minimized, thereby reducing the contact surface of the legs 111, and finally, the whole plugging net frame 110 is better in structural strength, difficult to deform, smaller in contact area with the room space and smaller in damage to myocardial tissues. Preferably, the width W of the legs 111 is less than or equal to 2mm. The thickness T of the legs 111 may be the same or different. Preferably, the thickness T of the legs 111 is less than or equal to 0.6mm.

Referring to fig. 2 and 5, the diameter D3 of the waist 112 is preferably smaller than the diameter D4 of the ventricular septum 200, so that a gap exists between the waist 112 and the diseased myocardium 210 surrounding the ventricular septum 200, preventing the waist 112 from propping against the diseased myocardium 210 surrounding the ventricular septum 200 after the occluding device 100 is expanded, and avoiding damage to the delicate myocardial tissue. At this point, the occluding device 100 is secured to the ventricular septum primarily by the clamping force of the occluding discs on both sides, and the waist 112 is free of radial support, resulting in significantly reduced compression and damage to delicate tissue adjacent the perforation. Thus, the waist 112 is prevented from being pressed to increase the perforation size, thereby reducing risks of residual shunt, falling off and the like, improving the survival rate of patients, and even advancing the operation time. Since the diameter D4 of the ventricular septum 200 is greater than 10mm for most patients, in one embodiment, the diameter D3 of the waist 112 is less than or equal to 10mm, preferably 4mm to 10mm, or less than 4mm.

With continued reference to fig. 5, in one embodiment, after the occluding device 100 is expanded, the maximum diameter D1 of the first occluding disk 113 is 10mm to 20mm greater than the diameter D4 of the ventricular septum penetration 200, e.g., the maximum diameter D1 of the first occluding disk 113 is 10mm to 60mm, the disk diameter defining the first occluding disk 113 capable of accommodating most ventricular septum penetration treatments and capable of spanning diseased myocardium 210. In one embodiment, after the occluding device 100 is expanded, the maximum diameter D2 of the second occluding disk 115 is 10mm to 20mm greater than the diameter D4 of the inter-ventricular septum 200. As the maximum diameter D1 of the second occluding disk 115 is 10mm to 60mm, the second occluding disk 115 may span the diseased myocardium 210 while accommodating most inter-ventricular septum perforation treatments.

The diameter of the first sealing disk 113 and the diameter of the second sealing disk 115 may be equal or unequal; when the diameters of the two occlusion discs are not equal, the right ventricle is smaller in size than the left ventricle according to normal heart anatomy, so the diameter of the occlusion disc in the left ventricle is preferably larger than the diameter of the occlusion disc in the right ventricle. In the embodiment of the present invention, the first sealing disc 113 is disposed in the right ventricle, the second sealing disc 115 is disposed in the left ventricle, the sealing disc in the right ventricle is used as the proximal sealing disc, the sealing disc in the left ventricle is used as the distal sealing disc, and the proximal sealing disc is detachably connected to the delivery system, so that the maximum diameter D1 of the first sealing disc 113 is smaller than the maximum diameter D2 of the second sealing disc 115.

Referring to fig. 6, after the plugging device 100 is expanded, the support leg 111 has a lowest point a and a highest point b in the longitudinal direction of the plugging grid 110, the support leg 111 further has a farthest point c in the radial direction of the plugging grid 110, the vertical distance between the lowest point a and the highest point b is the maximum height H3 of the support leg 111, the maximum height H3 of the support leg 111 is the maximum depth of the space, and the lowest point a and/or the farthest point c of the support leg 111 abuts against the room space.

The maximum height H3 of the foot 111 is not preferably too large or too small; if the maximum height H3 of the foot 111 is too large, endothelialization is not favored; conversely, the maximum height H3 is too small, and the leg 111 is easily deformed to fit the diseased myocardium at the ventricular septum. In order to solve these problems, the maximum height H3 of the leg 111 is preferably set to 1mm to 15mm, such as 1mm, 2mm, 5mm, 10mm, 15mm, more preferably 2mm to 10mm. Further, the lowest point a of the leg 111 is a vertical distance d from the longitudinal axis of the occlusion net frame 110 of more than 3mm, which distance d enables the leg 111 to effectively avoid the diseased myocardium 210.

The distance between the furthest points c defined by the different legs 111 is furthermore the maximum diameter of the closure disc. However, the furthest point c may be located between the highest point b and the lowest point a, or the distances from the furthest point a and the furthest point c to the highest point b may be equal. That is, the furthest point c may or may not contact the compartment space. When the furthest point c is between the highest point b and the lowest point a, compression of myocardial tissue can be further reduced. When the distances from the lowest point a to the highest point b are equal, the rod section between the lowest point a and the lowest point c can be contacted with myocardial tissue, so that the stability of the plugging instrument after implantation can be improved.

With continued reference to fig. 6, the free ends of the legs 111 preferably tilt outwardly and form an atraumatic surface, which reduces the damage to myocardial tissue from the free ends. The anti-damage surface can be a blunt surface, a cambered surface and other smooth surfaces.

Referring back to fig. 5, after the occluding device 100 is expanded, the minimum distance H1 between the first occluding disk 113 and the second occluding disk is preferably less than or equal to the thickness of the compartment space to provide sufficient and suitable clamping force to stably secure the occluding device 100 to the compartment space. In view of the fact that the cell separation thickness of most patients is greater than 8mm, the minimum distance H1 may be set to be less than or equal to 8mm, more preferably 1mm to 8mm.

For the purposes of the present invention, the most central property of the occluding device 100 is its ability to be held against myocardial tissue, and then the gripping force of the occluding device 100 consists essentially of two parts: the first is an independent support 111 on the disc surface, and the clamping force can be adjusted by adjusting the thickness of the support 111, for example, by increasing the width W and/or the thickness T of the support 111, the torsion resistance and the deformation resistance of the plugging grid 110 are improved, so that the clamping force is improved; the second is waist 112, change clamping force through the minimum interval H1 of changing axial height H2 and two shutoff dishes of waist 112, if directly adjust axial height H2, perhaps set up waist 112 to the structure that can warp to reach and let shutoff apparatus clamping force change along with the room interval thickness variation effect, and to the suitability of different patients or different room interval thickness stronger, avoid measuring room interval thickness selection corresponding shutoff apparatus in the art, simplified the design of shutoff ware specification, more make things convenient for the operator to use and select shutoff apparatus. The waist 112 preferably has an axial height H2 less than the ventricular septum thickness to reduce myocardial damage, alternatively the axial height H2 is less than or equal to 8mm.

In a preferred embodiment, the waist portion 112 is a deformable elastic structure to adaptively adjust the clamping force and ensure the stability of clamping.

In one embodiment, as shown in fig. 7, the waist portion 112 is a deformable mesh-like framework, which may optionally be a cutting stent.

In another embodiment, as shown in fig. 8, the waist 112 is a deformable spring structure.

In case the waist portion 112 is deformable, it is preferable that the waist portion 112 and the sealing disc are designed in a split type so as to adjust the clamping force of the same specification to an optimal condition in terms of process, raw material selection, structure, etc., so as to cope with different patients.

In a preferred embodiment, the occluding device 100 has an axially-extending hollow passageway that allows an external device to pass through the occluding device 100, facilitating the retrieval or replacement of the occluding device 100 by an external device. External devices include, but are not limited to, guide wires, pigtail catheters. If the plugging device 100 needs to be replaced, the plugging device 100 can be recovered or replaced by the guide wire reserved in the hollow channel, and the guide wire does not need to be withdrawn and the implanted guide wire is re-implanted, so that the operation difficulty is reduced, the operation time is shortened, and the damage to a patient is reduced. The hollow passage includes a groove 131 formed in the covering film 130 and an inner cavity of the waist 112.

Referring to fig. 11 and 12, in an embodiment, a slot 131 capable of opening and closing is provided in the middle of the cover 130 to allow an external device to pass through. The shape of the groove 131 is not limited, and includes, but is not limited to, a straight groove or a cross groove, and the cover film 130 on the first sealing disk 113 and the cover film 130 on the second sealing disk 115 are provided with the groove 131.

Referring to fig. 9 and 10, the occluding device 100 further includes a coupling device 114 for detachably coupling to a delivery system, such as a push rod of a delivery system. The connecting device 114 is embedded in the inner cavity of the waist 112 for fixation. Further, the connection means 114 is provided at the proximal end of the waist portion 112. Taking the first plugging tray 113 as a proximal plugging tray as an example, a connecting device 114 is disposed in the waist portion 112 near the proximal end. Optionally, the connection means 114 is internally threaded to threadably connect with the delivery system.

In a specific example, the connecting device 114 is fixedly connected to the waist 112 by at least two fixing pins 116, the at least two fixing pins 116 are disposed opposite to each other in the radial direction of the waist 112, and the at least two fixing pins 116 are inserted into the waist 112 to limit the movement of the connecting device 114 relative to the waist 112. Of course, there are other connection modes such as screwing, clamping, welding, bonding, etc., not limited to the fixing pin 116. In other cases, the connecting means 114 may be omitted and the waist 112 may be directly detachably connected to the conveyor system. In the embodiment of the present invention, the advantage of arranging the fixing pins 116 is that the two fixing pins 116 opposite to each other in the radial direction do not occupy too much space in the waist 112, so that a hollow channel large enough to pass through the external device is reserved between the two fixing pins 116, so that the guide wire or the pigtail catheter can not be withdrawn before and after the plugging device is implanted, when the specification of the plugging device is not properly selected, the guide wire or the pigtail catheter does not need to be replaced again, the operation risk is reduced, meanwhile, the operation time is saved, the operation operability is increased, and a convenient operation mode is provided for an operator.

The material of the coating 130 is a medical polymer material with good biocompatibility, for example, a polymer material such as PET material (polyethylene terephthalate) and PTFE (polytetrafluoroethylene). The connection mode between the covering film 130 and the plugging net frame 110 can be selected from the connection modes of hot melting, stitching and the like.

Referring to fig. 13 and 14, the covering film 130 may be fixed to the plugging grid 110 by stitching, which has the advantage of being more firmly fixed.

As shown in fig. 13, in an example, the leg 111 is provided with a through suture hole 111a, the suture hole 111a penetrates the leg 111 in the thickness direction of the leg 111, and the suture thread 120 penetrates the suture hole 111a to bind and fix the covering film 130 on the leg 111.

As shown in fig. 14, in another example, the leg 111 is provided with a non-penetrating suture groove 111b, and both sides of the leg 111 are provided with suture grooves 111b, so that the suture thread 120 is wound around the leg 111, and the movement of the suture thread 120 is restricted by the suture grooves 111b, and the cover 130 is bound and fixed to the leg 111.

In summary, the plugging device provided according to the embodiment of the invention should have the following technical effects:

1) The space formed by the two plugging discs in the unconstrained state of the plugging instrument enables the contact points of each plugging disc and the compartment space to cross the fragile lesion cardiac muscle around the perforation of the compartment space, thereby effectively reducing the secondary damage to the fragile cardiac muscle tissue;

2) The plugging disc is constructed by adopting the independent support legs, so that the plugging disc is more stable in molding after expansion, the inner side of the plugging disc is not easy to bulge and deform towards the room interval direction, the risk of attaching the inner side of the plugging disc to fragile myocardial tissues on the room interval is reduced, the risk of damaging the fragile myocardial tissues is reduced, the surface area of a metal material of the whole plugging net frame is small, nickel ions are less in precipitation, endothelialization is facilitated, the thrombosis risk is reduced, concurrency is reduced, the contact area between a single support leg and the room interval is very small, the problems of pressing papillary muscles, damaging chordae tendineae, backflow, heart failure and the like are avoided, the safety of the plugging instrument is higher, the clamping force of the plugging disc is stronger, the plugging device is not easy to shift, and the plugging performance is better; it should also be appreciated that because there is little damage to myocardial tissue, then the procedure can be advanced for more patient lives;

3) The clamping force of the plugging device is convenient to adjust, so that the treatment requirements of various room-interval perforations can be met, and the application range is wider;

4) Because the contact area between the plugging disc and the room space is small, the treatment position of the plugging disc at the room space is not easily limited, plugging devices can be placed at more positions to treat various room space perforations, the use is more flexible and convenient, and the application range is wider; in particular, even if the plugging device is arranged at a critical position of the compartment space (the critical position is generally the position for transmitting the electric signal), the transmission of the electric signal is not easy to be influenced by the plugging device because the contact area is very small, and the risk of signal conduction blocking is reduced;

5) The outer surface of the whole plugging device is flat and smooth, which is also beneficial to endothelialization, reduces the risk of thrombosis and further reduces complications;

6) The adhesive has better adhesion with tissues, can reduce residual shunt, also reduce the muscle loss caused by blood scouring of the tissues, and reduce the falling risk;

7) The plugging net rack has a simple structure, and is convenient for adding more functions, such as a full recovery function, a tissue protection function and the like.

It should be noted that several modifications and additions will be possible to those skilled in the art without departing from the method of the invention, which modifications and additions should also be considered as within the scope of the invention. Equivalent embodiments of the present invention will be apparent to those skilled in the art having the benefit of the teachings disclosed herein, when considered in the light of the foregoing disclosure, and without departing from the spirit and scope of the invention; meanwhile, any equivalent changes, modifications and evolution of the above embodiments according to the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A plugging device for treating inter-ventricular perforation, comprising a plugging grid and a covering film, wherein the covering film covers at least part of the surface of the plugging grid; the plugging net rack comprises two plugging discs which are oppositely arranged and a waist part connected with the two plugging discs; the waist for receipt in the inter-cell perforation; the two plugging discs are used for clamping cardiac muscle at two ends of the compartment perforation along the axial direction in the unconstrained state; both the plugging discs comprise a plurality of stand bars which are independently arranged, and all stand bars in each plugging disc are sequentially arranged along the circumferential direction around the longitudinal axis of the plugging net rack.

2. The occlusion device of claim 1, wherein both of said occlusion discs form a space in a direction away from each other when said occlusion device is in said unconstrained state, said space of each of said occlusion discs enabling all of said legs of the occlusion disc itself to avoid diseased myocardium surrounding said ventricular septum perforation and to clamp onto healthy myocardium.

3. The occlusion device of claim 1 or 2, wherein said leg has opposed fixed and free ends, said fixed end being connected to said waist, said free end being adapted to bear against healthy myocardium, and wherein the width of said leg decreases sequentially from said fixed end to said free end.

4. The occlusion device of claim 3, wherein said legs have a width of less than or equal to 2.0mm and/or a thickness of less than or equal to 0.6mm.

5. The occlusion device of claim 1 or 2, wherein said legs have a lowest point and a highest point in a longitudinal direction of said occlusion net frame and said legs have a furthest point in a radial direction of said occlusion net frame when said occlusion device is in said unconstrained state; the furthest point is located between the highest point and the lowest point, or the distances from the lowest point and the furthest point to the highest point are equal.

6. The occlusion device of claim 5, wherein a vertical distance between said lowest point and said highest point is between 1mm and 15mm.

7. The occlusion device of claim 6, wherein a vertical distance between said lowest point and said highest point is between 2mm and 10mm.

8. The occlusion device of claim 5, wherein a perpendicular distance from said nadir to a longitudinal axis of said occlusion net frame is greater than 3mm.

9. The occlusion device of claim 1 or 2, wherein a maximum diameter of at least one of said occlusion discs is 10 mm-20 mm greater than a diameter of said inter-ventricular septum perforation when said occlusion device is in said unconstrained state.

10. The occlusion device of claim 1 or 2, wherein the free ends of said legs are turned outwards and form an atraumatic surface.

11. The occlusion device of claim 1 or 2, wherein a minimum distance between two of said occlusion discs is less than or equal to a thickness of a compartment space when said occlusion device is in said unconstrained state.

12. The occlusion device of claim 1 or 2, wherein said waist is a deformable elastic structure.

13. The occlusion device of claim 1 or 2, wherein said waist has at least one of the following features:

the axial height of the waist is less than the chamber spacing thickness;

the waist has a diameter less than the diameter of the inter-cell perforation.

14. The occlusion device of claim 1 or 2, wherein said occlusion device has an axially through hollow passage allowing an external device to pass through said occlusion device, said hollow passage comprising a groove on said covering membrane and an inner lumen of said waist.

15. The occlusion device of claim 14, wherein a connection means is disposed in the lumen of the waist for detachable connection with a delivery system.

16. The occlusion device of claim 15, wherein said connecting means and said waist are fixedly connected by at least two fixation pins, at least two of said fixation pins being disposed radially opposite said waist, and said hollow channel being reserved between said radially opposite fixation pins.

17. The plugging apparatus according to claim 1 or 2, wherein the covering film is fixed on the plugging net frame in a suturing manner, the supporting legs are provided with through suture holes and/or non-through suture grooves, and the plugging net frame is bound and fixed with the covering film through the suture holes and/or the suture grooves.