CN218045477U

CN218045477U - Shunt device between atria

Info

Publication number: CN218045477U
Application number: CN202221302922.4U
Authority: CN
Inventors: 赵向前; 沈斌; 汪泽辉
Original assignee: Shanghai Yixin Medical Devices Co ltd
Current assignee: Shanghai Yixin Medical Devices Co ltd
Priority date: 2022-05-27
Filing date: 2022-05-27
Publication date: 2022-12-16
Anticipated expiration: 2032-05-27

Abstract

The utility model relates to the technical field of medical equipment, especially, relate to a diverging device between atrium, including conduction portion and set up first locating body, the second location body in conduction portion both sides respectively, conduction portion, first locating body, second location body are woven a silk by single and are integrative to be worked out and form. In the embodiment of the application, adopt foretell diverging device between atrium, through the mode of single silk integration establishment of weaving and need not to handle the silk head in bulk, do not have unnecessary structure to stick out to in the left and right atrium after the installation, be difficult for generating the thrombus, simple structure moreover, the size is littleer during the shrink, gets to the damage of approach blood vessel littleer at implantation in-process.

Description

Shunt device between atria

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a diverging device between atrium.

Background

Heart failure (heart failure) refers to a heart circulatory disturbance syndrome caused by venous return blood volume not being discharged from the heart sufficiently due to the failure of the systolic function and/or diastolic function of the heart, resulting in blood stasis in the venous system and insufficient blood perfusion in the arterial system. Heart failure is a serious disease with high incidence and mortality, and can be classified into left heart failure, right heart failure and whole heart failure according to the occurrence part of the heart failure, and also classified into systolic heart failure and diastolic heart failure according to the clinical manifestations of the heart failure, wherein the Diastolic Heart Failure (DHF) accounts for about half of all patients with heart failure. More than 1200 thousands of heart failure patients exist in China, namely the incidence rate of the heart failure is about 2-3%, wherein about 600 thousands of diastolic heart failure patients exist, the heart failure of old people is mainly diastolic heart failure, and the number of the diastolic heart failure patients of the old people accounts for 66.99% of the total number of the diastolic heart failure patients.

The causes of heart failure mainly include hypertension, coronary heart disease, myocardial infarction, heart valve diseases, atrial fibrillation, cardiomyopathy and the like. Cardiovascular disease causes damage to the left ventricle leading to pathological remodeling of the left ventricle and subsequent loss of cardiac function, which means that each successful treatment of a myocardial infarction patient results in a potential heart failure patient.

In the treatment of heart failure, the existing various means have defects, such as the optimization of drug therapy cannot fundamentally remove the cause of disease, and the possibility of repeated attack still exists; cardiac Resynchronization Therapy (CRT) is ineffective in at least 20% of patients with heart failure; the Left Ventricle Auxiliary Device (LVAD) operation needs extracorporeal circulation, which not only has high incidence rate of serious trauma and complication, but also has high price and is difficult to obtain, and simultaneously, the operation condition is not available in China; heart transplantation can fundamentally solve the problem, but donor sources are very limited and expensive.

Publication No.: CN113558820A discloses a shunt device, which comprises two discs and a waist part connecting the two discs to form a shunt channel, wherein the two discs have a plurality of independent petal-shaped structures and are attached and anchored with the atrial wall, however, in the structure, the disc attached with the atrial wall is composed of a plurality of independent petal-shaped structures, so the adherence and the anchoring effect are not good, and the shunt cannot be well ensured to be stably anchored at the position of the atrial wall stoma all the time; publication No.: CN110536657A discloses a shunt for redistributing atrial blood volume, which adopts an hourglass-shaped shunt mode, but the hourglass-shaped shunt device is easy to displace under the scouring of blood flow, changes the installation angle, forms an artificial small included angle with the interatrial septum, easily forms vortex and thrombus in the included angle space, and attaches a polymer membrane on the outer surface of the ePTFE shunt device, possibly causing complications such as thrombus and hemolysis.

Because the shunt device is implanted with the stoma treatment before the shunt device is implanted, the existing shunt device is basically manufactured by cutting a tectorial membrane structure or weaving a plurality of strands of filaments, the structure is complex, the structure often protrudes into the left atrium and the right atrium after the shunt device is implanted, the risk of subsequent thrombosis is improved, and the shunt device still has a larger cross section area in a contraction state, so the diameter of a sheath tube of a conveyor is large, the conveyor is tortuous for some cases with complicated approaches and the pathological change structure lacks adaptability.

SUMMERY OF THE UTILITY MODEL

To the deficiency of the prior art, the utility model provides an atrium room diverging device of simplified structure.

In order to achieve the above purpose, the utility model is realized by the following technical scheme.

The application provides an interatrial shunt device, which comprises a first positioning body, a second positioning body and a conduction part, wherein the first positioning body and the second positioning body are respectively positioned at two sides of an interatrial septum;

the conduction part, the first positioning body and the second positioning body are formed by weaving and shaping a weaving wire, two ends of the weaving wire are respectively abutted against the atrium shunting device, and two ends of the weaving wire do not protrude out of the atrium shunting device.

Further, in the above inter-atrial shunt device, the braided wire is made of one or a combination of nickel-titanium alloy and platinum-iridium alloy.

Further defined, the interatrial shunt device as described above, wherein the filament diameter of the braided wire is between 0.08 and 0.3mm.

Further defined, the interatrial shunt device as described above, wherein an edge of the first retainer projects beyond an edge of the conduit.

Further defined, the interatrial shunt device of the above, wherein the first retainer is disk-shaped.

Further defined, the interatrial shunt device as described above, wherein the first retainer edge is drawn closer to the conduction portion.

Further defined, the interatrial shunt device as described above, wherein the edge of the second positioning member protrudes beyond the edge of the conduction portion.

Further defined, the interatrial shunt device as described above, wherein the second positioning body is disc-shaped.

Further defined, the interatrial shunt device as described above, wherein the second positioning body is a double-layer structure.

Further, the second positioning body is provided with a second guiding portion, and the second guiding portion is connected to the second positioning body.

Further defined, the above-mentioned interatrial shunt device, wherein, still include:

and a diaphragm covering the surfaces of the first positioning body and the second positioning body.

Compared with the prior art, the utility model discloses beneficial effect includes at least:

1. adopt single weaving silk to compile conduction portion and first locating body, second locating body, and weave silk both ends respectively the butt on this atrium diverging device, need not unnecessary structure and handle weaving silk end for diverging device overall structure is more simple. In addition, because the filament diameter of the braided filaments is small, the cross-sectional area when contracted to the minimum diameter is small, enabling contraction to a smaller sheath when loaded into a delivery unit that mates with an atrial shunt.

2. The inter-atrium shunt device can be contracted to a smaller sheath tube, so that the outer diameter of the transmission unit is reduced, after the outer diameter of the transmission unit is reduced in the specific operation process, the damage to the approach blood vessel is reduced in the process that the transmission unit enters the atrium along the approach path through the puncture point, and the transmission unit can have better flexibility after the outer diameter is reduced, so that the adaptability to the tortuous blood vessel is improved, and the transmission unit has better passing performance on the blood vessel with complex lesion compared with the thicker transmission unit outer diameter.

3. First positioning body divergent edge draws close to second positioning body one side, and the second positioning body is bilayer structure and middle part to lead to one side indent of portion for diverging device implantation back first positioning body, second positioning body can realize better adherence and anchoring effect about self elasticity between the atrium.

4. Because first locating body, second locating body are woven silk by single and are woven and be worked out, so first locating body and second locating body do not have unnecessary structure and stand out to the left and right atrium in the back that finishes installing, can make the quick endothelialization of first locating body, second locating body, be difficult for producing the thrombus.

5. Because the first positioning body, the second positioning body and the conducting part are woven by a single weaving wire, no redundant weaving wire protrudes from the contact surface of the first positioning body, the second positioning body and the conducting part with the heart structure, and the damage to the atrium can be avoided in the frequent contraction process of the atrium.

6. The surfaces of the first positioning body and the second positioning body are covered with the diaphragms, so that the blood flow isolation effect can be achieved, and better adherence is provided for the first positioning body and the second positioning body.

Drawings

FIG. 1 is a schematic illustration of an embodiment of an interatrial shunt apparatus according to the present application;

FIG. 2 is a front view of an interatrial shunt device according to an embodiment of the present application;

FIG. 3 is a side view of an interatrial shunt device according to an embodiment of the present application;

FIG. 4 is a schematic side cross-sectional view of an interatrial shunt device according to an embodiment of the present application;

FIG. 5 is a schematic side cross-sectional view of an interatrial shunt device according to an embodiment of the present application;

FIG. 6 is a schematic side cross-sectional view of an interatrial shunt device according to an embodiment of the present application;

FIG. 7 is a schematic side cross-sectional view of an interatrial shunt device according to an embodiment of the present application;

FIG. 8 is a front view of an interatrial shunt device according to an embodiment of the present application;

FIG. 9 is a schematic view of the installation configuration of the interatrial shunt device according to the embodiment of the present application.

Reference numerals

A braided wire-100, a conduction part-110, a circulation cavity-111, a first positioning body-121, a second positioning body-122, a divergent end-1221, a convergent end-1222, a cross hole-123, a cross node-124, a circulation port-125 and a diaphragm-200.

Detailed Description

The technical solutions in the embodiments of the present application will be described below clearly with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some, but not all, embodiments of the present application. All other embodiments that can be derived by one of ordinary skill in the art from the embodiments given herein are intended to be within the scope of the present disclosure.

The terms first, second and the like in the description and in the claims of the present application are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It will be appreciated that the data so used may be interchanged under appropriate circumstances such that embodiments of the application may be practiced in sequences other than those illustrated or described herein, and that the terms "first," "second," and the like are generally used herein in a generic sense and do not limit the number of terms, e.g., the first term can be one or more than one. In addition, "and/or" in the specification and claims means at least one of connected objects, a character "/" generally means that a preceding and succeeding related objects are in an "or" relationship.

The server provided in the embodiments of the present application is described in detail with reference to the accompanying drawings through specific embodiments and application scenarios thereof.

Example 1:

as shown in fig. 1 to 4, the present embodiment provides an atrial shunt device including an introduction part 110, and a first positioning body 121 and a second positioning body 122 respectively provided on both sides of the introduction part 110, wherein the introduction part 110, the first positioning body 121, and the second positioning body 122 are integrally woven from a single woven wire 100, both ends of the woven wire 100 are respectively abutted against the atrial shunt device, and both ends do not protrude outside the atrial shunt device, and the woven wire 100 can be, but is not limited to, a plastically expandable or self-expandable material such as nickel-titanium alloy or platinum-iridium alloy, and has a wire diameter of 0.12 to 0.2 mm.

The conduction part 110 has a circulation chamber 111 for circulating blood therethrough, the circulation chamber 111 has a circular or substantially circular cross section, the first positioning body 121 and the second positioning body 122 have a disk shape, the first positioning body 121 is provided on the first side of the conduction part 110 and has a divergent shape, and the first positioning body 121 gradually shifts toward the second positioning body 122 along a divergent path, in other words, the edge of the first positioning body 121 is closer to the second positioning body 122 than the center. The second positioning member 122 is disposed on the second side of the conduction part 110, that is, the conduction part 110 is far away from one side end of the first positioning member 121, the second positioning member 122 is a folded double-layer structure, and is made by folding and furling the conduction part 110 along one side far away from the conduction part 110 after the end far away from one side of the first positioning member 121 of the conduction part 110 diverges, the diverging end 1221 thereof is located on the second side of the conduction part 110, the furling end 1222 thereof is offset towards one side close to the conduction part 110 and encloses a circulation port 125 corresponding to the boundary position of the cross section of the circulation cavity 111, and the diameter of the circulation port 125 is the same as the diameter of the circulation cavity 111 to ensure that the blood in the circulation cavity 111 circulates normally.

As shown in fig. 9, after the atrial septal drainage device is implanted into the atrial septal stoma, the divergent edge of the first positioning member 121 initially approaches the conduction portion 110 and deforms due to the contact with the atrial septum after implantation, so that the anchoring force between the first positioning member 121 and the atrial septum is increased by the elastic force of the deformation, in other words, the edge of the first positioning member 121 approaches the second positioning member, thereby increasing the holding of the atrial septum. The conduction part 110 penetrates through the interatrial septum stoma, and the circulation cavity 111 can satisfy the blood circulation.

The first positioner 121 and the second positioner 122 have a mesh structure, and are woven in such a manner that a single braided wire 100 meanders to form a plurality of crossing nodes 124, the crossing nodes 124 are intersections formed by crossing two braided wires 100 formed by bending the single braided wire 100, the braided wires 100 forming the crossing nodes 124 enclose a plurality of crossing holes 123 having a quadrangular structure, the two braided wires 100 forming the single crossing nodes 124 can be in a mutually connected state or a mutually separated state at the positions of the crossing nodes 124, the crossing holes 123 are in a closed state in a contracted state of the cardiopulmonary bypass device, and the crossing holes 123 are in an open state after implantation of the cardiopulmonary bypass device is completed.

The conduction part 110 is formed by a plurality of parallel knitting yarns 100 which are formed by bending a single knitting yarn 100 in an annular array, and gaps are left among the plurality of parallel knitting yarns 100, so that the conduction part 110 can have certain extensibility and contractibility in the radial direction.

The crossing nodes 124 at the edge positions of the first positioning body 121 and the second positioning body 122 and the braided wire 100 are passivated, so that the atrial trauma during and after the implantation is reduced.

In this embodiment, the conduction part 110, the first positioning body 121, and the second positioning body 122 are woven by a single weaving wire 100, so that the inter-atrial shunt device has only two wire ends of the weaving wire 100, and the two end parts of the weaving wire 100 are respectively abutted to the inter-atrial shunt device, so that the discrete wire ends of the atrial shunt device do not need to be processed by other parts or structures after weaving is completed, thereby preventing redundant structures from protruding into the left atrium and the right atrium, and reducing the risk of thrombosis.

Example 2:

as shown in fig. 5, in this embodiment, the length of the conducting part 110 is extended, that is, the conducting parts 110 with different lengths are woven to satisfy the atrial septal with different thicknesses, so as to adapt to different widths of the atrial septal, so that the anchoring forces of the first positioning body 121 and the second positioning body 122 are more suitable, thereby achieving a better shunting effect;

of course, the conduction part 110 may be woven by a material having a higher elasticity or ductility, so that it can be adapted by self-deformation when dealing with atrial septa of different thicknesses.

Example 3:

as shown in fig. 6, in this embodiment, the second positioning body 122 is a folded double-layer structure, and is made by folding and furling the end of one side of the conducting part 110 away from the first positioning body 121, and then diverging and then folding and furling the end of one side of the conducting part 110 close to the first positioning body 110, and the diverging end 1221 thereof is located at one side of the conducting part 110 away from the first positioning body 121, and the furling end 1222 thereof is offset towards one side close to the first positioning body 121 and surrounds the outer circumferential surface of the conducting part 110, at this time, the blood directly flows through the flowing cavity 111, and the double-layer structure of the second positioning body 122 can avoid forming a small included angle with the atrial septum after implantation, thereby avoiding forming vortex and thrombus in the included angle space.

Example 4:

as shown in fig. 7, in this embodiment, the first positioning body 121 and the second positioning body 122 are symmetrically disposed, that is, the second positioning body 122 is a single-layer disc structure, and at this time, the second positioning body 122 is disposed at one side end of the conduction part 110 far from the first positioning body 121 and has a divergent shape, and gradually deviates to one side close to the first positioning body 121 along a divergent path, and the second positioning body 122 in this structure can further reduce the cross-sectional area during contraction, so that it can contract to a smaller sheath when loading the transmission unit matched with the atrial shunt device.

Example 5:

as shown in fig. 8, in this embodiment, the braided wire 100 is woven with the first positioner 121 and the second positioner 122 so that the number of crossing nodes 124 is reduced by increasing the inner diameter of the crossing hole 123, and the surface of the first positioner 121 and the second positioner 122 is covered with the separator 200.

The membrane 200 is in a double-layer structure at the position of the crossing hole 123 of the first positioning body 121 and the second positioning body 122, the double-layer membrane 200 at the position of the crossing hole 123 is bonded together by hot melt bonding or glue bonding, and the first positioning body 121 and the second positioning body 122 are completely wrapped by the membrane 200, so that the membrane has an integral structure, wherein the first positioning body 121 and the second positioning body 122 provide supporting force by utilizing a woven structure thereof, and the membrane can play a role and a purpose of isolating blood flow.

The boundary of the diaphragm 200 covering the first positioning member 121 and the second positioning member 122 is not larger than the actual size boundary of the first positioning member 121 and the second positioning member 122, that is, the diaphragm 200 does not affect the blood flow in the flow-through cavity 111.

In this embodiment, due to the above structure, the structural integrity of the first positioning body 121 and the second positioning body 122 is stronger, so that the overall structure of the atrial shunt device can be further simplified by increasing the inner diameter of the cross hole 123 and reducing the number of the cross nodes 124, and the atrial shunt device has stronger expansion and contraction properties and better adherence effect.

Example 6:

the embodiment of the application provides an implant diverging device's subassembly, wherein, including atrium room diverging device, still include and hold atrium room diverging device and transmit atrium room diverging device to the transmission unit of interatrial septum middle stoma position under atrium room diverging device compression state.

In this embodiment, the inter-atrial shunt device in the contracted state is fed into the atrium through the puncture point and along the approach path by the transmission unit in the specific operation process, and since the inter-atrial shunt device is woven by one weaving wire 100 and the diameter of the woven wire is small, the cross-sectional area of the inter-atrial shunt device contracted to the minimum diameter is small, so that the transmission unit for transmitting the inter-atrial shunt device is smaller in size, better in flexibility, stronger in adaptability to the tortuous blood vessels, and less in damage to the approach blood vessels in the implantation process of the inter-atrial shunt device.

It should be noted that, in this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrases "comprising a component of' 8230; \8230;" does not exclude the presence of another like element in a process, method, article, or apparatus that comprises the element. Further, it should be noted that the scope of the methods and apparatus of the embodiments of the present application is not limited to performing the functions in the order illustrated or discussed, but may include performing the functions in a substantially simultaneous manner or in a reverse order based on the functions involved, e.g., the methods described may be performed in an order different than that described, and various steps may be added, omitted, or combined. In addition, features described with reference to certain examples may be combined in other examples.

While the present embodiments have been described with reference to the accompanying drawings, it is to be understood that the present embodiments are not limited to those precise embodiments, which are intended to be illustrative rather than restrictive, and that various changes and modifications may be effected therein by one skilled in the art without departing from the scope of the appended claims.

Claims

1. An interatrial shunt device is characterized by comprising a first positioning body, a second positioning body and a conduction part, wherein the first positioning body and the second positioning body are respectively positioned at two sides of an interatrial septum;

2. The interatrial shunt device of claim 1, wherein said braided wire is one of nitinol and platinum-iridium.

3. The interatrial shunt device of claim 1, wherein said braided wire has a filament diameter of 0.08 to 0.3mm.

4. The interatrial shunt device of claim 1, wherein an edge of said first retainer projects beyond an edge of said conduit.

5. The interatrial shunt device of claim 4 wherein said first retainer is disk-shaped.

6. The interatrial shunt device of any one of claims 4 or 5 wherein said first retainer edge is drawn toward a side adjacent said passage.

7. The interatrial shunt device of claim 1, wherein an edge of said second positioning member projects beyond an edge of said conduction portion.

8. The interatrial shunt device of claim 7, wherein said second positioning body is disk-shaped.

9. The interatrial shunt device of claim 7 wherein said second positioning member is a double-layered structure.

10. The interatrial shunt device of any one of claims 7 to 9 wherein said second spacer intermediate portion is recessed toward a side adjacent said passage portion.

11. The interatrial shunt device of claim 1, further comprising: