CN112773423A

CN112773423A - Interatrial septum fistulation device

Info

Publication number: CN112773423A
Application number: CN202110185480.3A
Authority: CN
Inventors: 沈碧峰; 朱大伟; 付亮辉
Original assignee: Yinaide Medical Technology Shanghai Co ltd
Current assignee: Yinaide Medical Technology Shanghai Co ltd
Priority date: 2021-02-10
Filing date: 2021-02-10
Publication date: 2021-05-11

Abstract

The invention discloses an interatrial septum fistulation device, which comprises a main body, wherein the main body comprises a support ring and skirt parts positioned at two sides of the support ring, and the main body is formed by cutting a metal pipe; and a pressurized bladder for expanding the body and inverting the skirt about the support ring; in the first state, the pressurizing liquid bag is in a contracted state, the main body is sleeved on the periphery of the pressurizing liquid bag and is also in the contracted state, the support ring and the skirt portion are attached to the peripheral wall of the pressurizing liquid bag, and the main body is conveyed through the pressurizing liquid bag; in the second state, the pressurizing liquid bag expands to drive the main body sleeved on the periphery of the pressurizing liquid bag to expand, wherein the support ring radially expands, and the turning angle alpha of the skirt part is 30-120 degrees. The pressurized sac of the invention can expand the open state of the interatrial septum hole while expanding the main body, so that the open state of the hole is kept for a longer time; the pressurized sac expands the body to be completely attached to the interatrial septum to adapt to the interatrial septum structure, so that the body is more firmly fixed at the interatrial septum position.

Description

Interatrial septum fistulation device

Technical Field

The invention relates to the field of medical equipment, in particular to an interatrial septum fistula-making device.

Background

Heart failure (Heart failure) is the ultimate result of various cardiovascular events and the cumulative effect of various cardiac abnormalities, ultimately leading to a decrease in cardiac pumping. Once the cardiovascular patients have the clinical manifestations of heart failure, the prognosis is poor. The more severe the heart failure, the higher the risk of death. Heart failure is an abnormal change in the structure and function of the heart caused by various causes, causing dysfunction in the systolic ejection and/or diastolic filling functions of the ventricles, resulting in a complex group of clinical syndromes, mainly manifested by a decrease in exercise tolerance (dyspnea, fatigue) and fluid retention (pulmonary congestion, systemic congestion and peripheral edema).

According to statistics, 17% -45% of heart failure patients die within 1 year after diagnosis is confirmed, and the life cycle of most patients is within 5 years. In addition, the number of heart failure patients is rapidly increasing, and in the united states for example, the number of heart failure people in 2030 will rise from 580 to 850 million in 2012. The incidence rate of heart failure in China is about 1.3%, the number of heart failure patients is about 1800 ten thousand, and about 50 ten thousand new-onset people exist each year.

Heart failure with preserved ejection fraction (HFpEF, LVEF value > 50%) is a common type of Heart failure, accounting for about 50% of the cases of Heart failure. Epidemiology has shown that HFpEF incidence is on the rise worldwide. Currently, for Heart failure (HFrEF) with reduced ejection fraction, drugs such as cardiotonic, diuretic, and vasodilator drugs are used to effectively slow down the progression of this type of Heart failure exacerbation. However, no drug or device has been available to date that can significantly reduce mortality or hospitalization risk in HFpEF patients. In addition, HFpEF is associated with many complications, and little is currently known about its complex pathophysiology. HFpEF is generally characterized by elevated left atrial pressure (especially during exercise), causing pulmonary hypertension, leading to pulmonary congestion and dyspnea. Dyspnea is a major cause of frequent hospitalizations of HFpEF patients. Retrospective data show that while lung capillary wedge pressure (PCWP) is normal at rest, PCWP rises dramatically upon exercise. This is associated with a 6min walking distance and a reduction in long term survival. Thus, PCWP at rest or exercise may be a therapeutic target for HFpEF patients.

Therefore, the present invention is directed to an interatrial fistula-creating device implanted in the interatrial space of HFpEF patients to form a hole at the interatrial space, so as to reduce the left atrial pressure during movement of the HFpEF patients, thereby reducing the pulmonary artery pressure and PCWP, reducing the occurrence of pulmonary congestion, and effectively relieving the symptoms of dyspnea and fatigue of the HFpEF patients.

Disclosure of Invention

The invention aims to provide an interatrial septum fistula-making device. The interatrial septum stoma device of the present invention expands the main body by pressurizing the sac to secure the main body in the interatrial position. The pressurized liquid sac can expand the interatrial space while expanding the main body so as to expand the open state of the hole, so that the open state of the hole is kept for a longer time; the pressurizing sac can well adapt to the atrial septum structure, so that the main body is expanded to be completely attached to the atrial septum, the main body is more firmly fixed at the position of the atrial septum, and finally the effects of properly reducing the blood pressure in the left atrium, reducing the volume of the left atrium, relieving the symptoms of chronic heart failure, improving the function of the left heart and preventing the insufficiency of the left heart are achieved.

The invention provides a interatrial septum fistula-making device, which comprises a main body, a plurality of fistula-making holes and a plurality of fistula-making holes, wherein the main body comprises a support ring and skirt parts positioned at two sides of the support ring, and is cut by a metal pipe; and a pressurized bladder for expanding the body and inverting the skirt about the support ring; in a first state, the pressurizing liquid bag is in a contracted state, the main body is sleeved on the periphery of the pressurizing liquid bag and is also in a contracted state, the support ring and the skirt portion are attached to the peripheral wall of the pressurizing liquid bag, and the main body is conveyed through the pressurizing liquid bag; in a second state, the pressurizing liquid bag expands to drive the main body sleeved on the periphery of the pressurizing liquid bag to expand, wherein the support ring radially expands, and the turning angle alpha of the skirt part is 30-120 degrees; preferably 30-90 degrees.

In another preferred embodiment, the support ring and the skirts are in a network structure.

In another preferred example, the support ring comprises a support body and optionally a plurality of spacing rings, the support body is of a grid structure, and the spacing rings are annular and are arranged perpendicular to the axial direction of the main body.

The support body expands in the radial direction and optionally in the axial direction, and the stop collar is used for limiting the expansion of the support body in the radial direction and does not increase continuously due to continuous change of the pressure of the pressurizing liquid sac.

In another preferred embodiment, the lattice structure unit of the support may be, but is not limited to, a sine structure or a quadrilateral, hexagonal or octagonal structure; preferably square, rectangular, diamond, shuttle.

In another preferred example, the number of the grid structure units of the support body is 6-120; preferably 6-100.

In another preferred embodiment, one or more sides of the mesh are curved to provide a greater amount of deformation.

In another preferred example, the number of the limiting rings is 1-10; preferably, 2 to 8; more preferably, 3 to 6.

In another preferred embodiment, the limiting ring is an annular structure formed by splicing a plurality of straight sections and a plurality of bent sections in series end to end.

In another preferred embodiment, a plurality of the spacing rings are uniformly arranged at intervals, and the intervals are 0.5-2 mm; preferably 0.7-1.5 mm.

In another preferred embodiment, the support body and the stop collar are integral or integrally formed.

In another preferred embodiment, the skirt portion includes a first skirt portion and a second skirt portion.

In another preferred embodiment, each of the skirts may be, but not limited to, a mesh, petals, or the like.

In another preferred embodiment, each skirt portion comprises a plurality of single bodies, wherein the single bodies are independent from each other and are uniformly spaced around the circumference of the support body.

In another preferred embodiment, the number of said monomers is 3 to 16.

In the contracted state, each of the skirts is arranged along the axial direction of the main body, namely, the first skirt is arranged from the far end of the support body to the far end of the main body, and the second skirt is arranged from the near end of the support body to the near end of the main body;

it should be noted that "distal" refers to the end of the interatrial septum ostomy device that is distal to the operator when in use; by "proximal" is meant the end of the interatrial septum ostomy device that is, in use, near the operator.

In the expanded state, the first skirt everts outwardly around the distal end of the support body and the second skirt everts outwardly around the proximal end of the support body.

In another preferred embodiment, the body and the skirt are integral or integrally formed.

In another preferred embodiment, the support body and the skirt are integral or integrally formed.

In another preferred embodiment, the diameters of the limiting rings in each row are equal after the pressurizing liquid sac expands.

In another preferred embodiment, the diameters of the limiting rings in each row are increased by 1-1.5 times from the middle to two sides after the pressurizing liquid sac expands.

In another preferred embodiment, the diameters of the limiting rings of each row are increased by 1-1.5 times from one side to the other side after the pressurizing liquid sac expands.

In another preferred example, the diameters of the limiting rings in each row are in different proportions after the pressurizing liquid sac expands.

In another preferred embodiment, the body is manufactured by a laser cutting process.

In another preferred example, the material of the main body is stainless steel, cobalt-chromium alloy, cobalt-nickel alloy or one of platinum, gold, palladium and tantalum or an alloy thereof.

In another preferred example, the pressurizing liquid bag comprises 1-3 pressurizing bag bodies, a pressurizing bag body connecting pipe, a pressurizing liquid bag joint and a hollow pipe, wherein 1-3 pressurizing interfaces which are communicated with the pressurizing bag bodies in a fluid mode are respectively arranged at the far end of the pressurizing liquid bag joint, the pressurizing interfaces and the pressurizing bag bodies are in one-to-one correspondence, and 1 guide wire interface is used for being communicated with the hollow pipe.

In another preferred embodiment, the pressurizing bladder is made of PU, TPU, PBAX or nylon.

In another preferred embodiment, in the case that the number of the pressurizing capsules is 1, the length of the pressurizing capsule is 10-60mm, and the expanded shape thereof may be cylindrical or dumbbell-shaped; when 1 pressurizing bag body and main part cooperation use, the main part is placed in the middle part of pressurizing bag body, after expanding the main part, because the restriction of spacing collar makes the pressurizing bag body be the dumbbell shape after expanding the main part, and pressurizing bag body both ends portion expand and turn over the skirt portion.

In another preferred example, in the case of a number of 1 said pressurizing bladder, said pressurizing bladder is a compliant bladder.

In another preferred embodiment, in the case of a number of 2 said pressurizing bladders, two of said pressurizing bladders are arranged axially adjacent to each other, each of said pressurizing bladders having a length of 5-30mm and an expanded shape of cylindrical, spherical or oval-spherical; when the 2 pressurizing capsules are matched with the main body for use, the main body is placed in the middle of the 2 pressurizing capsules, after the main body expands along with the pressurizing capsules, the support ring expands along with the main body, and the skirts on two sides are turned upwards.

In another preferred example, in the case of a number of said compression bladders of 2, 2 of said compression bladders are compliant bladders.

In another preferred embodiment, in the case of a number of 3 said pressurizing balloons, 3 said pressurizing balloons are arranged axially one after the other, the distal one having a length of 5-30mm, the proximal one having a length of 5-30mm, the intermediate one having a length of 2-10mm and being cylindrical, spherical or oval-spherical in shape after expansion; when 3 pressurizing utricules and the main part cooperation is used, the support ring of main part is placed in the middle the pressurizing utricule, is located the skirt portion of support ring both sides and is placed in the pressurizing utricule of both sides, after the main part expands with the pressurizing utricule, the support ring expands thereupon, both sides the skirt portion upwards upset.

In another preferred example, in the case of a number of 3 said pressurizing balloons, the distal and proximal pressurizing balloons are compliant balloons and the intermediate pressurizing balloon is a non-compliant balloon.

In another preferred embodiment, the outer diameter of the hollow tube is smaller than the inner diameter of the pressurizing balloon connecting tube, the pressurizing balloon connecting tube and the hollow tube are welded and closed at the distal end, a pressurizing cavity is formed between the pressurizing balloon and the hollow tube, and the pressurizing balloon is pressurized and expanded through the pressurizing cavity.

In another preferred embodiment, the interior of the hollow tube may be guided by a guide wire.

In another preferred embodiment, the guide wire has a gauge of 0.010 "to 0.050".

In another preferred example, after the pressurized liquid sac expands, the inner diameter of the support ring is 4-13mm, and the axial length of the support ring is 1.5-6 mm.

In another preferred embodiment, after the pressurized liquid sac is expanded, the height h of the skirt parts on two sides is 2-8mm, and the maximum distance s between tail ends of the skirt parts on two sides is 3-12 mm.

In another preferred embodiment, the device comprises a development mark, which is attached to the body by means of an inlay or welding.

In another preferred example, the number of the development marks is 3-30.

In another preferred embodiment, the support ring and/or the skirt are provided with a circular hole, the development mark being provided in the circular hole.

In another preferred example, the material of the development mark is one of platinum, gold, palladium and tantalum or an alloy thereof.

In another preferred embodiment, the surface of the body is coated with a drug that inhibits endothelialization, which may be, but is not limited to, paclitaxel or a rapamycin derivative.

In another preferred embodiment, the surface of the main body is coated with an anticoagulant drug, which may be but is not limited to heparin.

It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be reiterated herein, but to the extent of space.

Drawings

In order to more clearly illustrate the embodiments of the present invention 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 invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

Fig. 1 is a front view of the body of an interatrial septum ostomy device in an expanded state according to one embodiment of the invention;

fig. 2 is a side view of the body of the interatrial septum ostomy device of fig. 1;

fig. 3 is a perspective view of the body of the interatrial septum ostomy device of fig. 1;

fig. 4 is a side view of the body of the interatrial septum ostomy device of fig. 1 in a contracted state;

fig. 5 is a perspective view of the body of the interatrial septum ostomy device of fig. 4;

fig. 6a is a front view of a skirt portion of a body of an interatrial septum ostomy device according to an example of the invention in the form of an alternative lattice structure;

fig. 6b is a front view of a skirt portion of a body of an interatrial septum ostomy device according to an example of the invention in the form of yet another lattice structure;

FIG. 6c is an expanded view of the body of FIG. 6 b;

fig. 7 is a side view of the body of the interatrial septum ostomy device of fig. 1 in another expanded state;

figure 8a is a front view of an interatrial ostomy device provided with a pressurizing bladder according to an embodiment of the invention;

FIG. 8b is a cross-sectional view of the pressurized bladder of FIG. 8 a;

fig. 9 is a schematic view of the body of the interatrial septum ostomy device of fig. 1 mated with the pressurized sac of fig. 8;

fig. 10 is a front view of the body of the interatrial septum ostomy device of fig. 1 with the support ring in a gradient expansion in an expanded state;

fig. 11 is a side view of the body of the interatrial septum ostomy device of fig. 10;

fig. 12 is a partially enlarged view of a portion I of fig. 11;

figure 13 is a front view of an interatrial ostomy device provided with two pressurizing bladders according to one embodiment of the invention;

fig. 14 is a front view of an interatrial ostomy device provided with three pressurizing bladders in one example of the invention;

figures 15a-15c are mid-sectional cross-sectional views of the pressurizing bladder connection tube of figure 14.

In the drawings, each symbol is as follows:

1-a support ring;

2-a skirt;

3-a support;

4-a limit ring;

5-pressurizing the capsule body;

6-pressurizing the bladder connecting pipe;

7-pressurized liquid bladder joint;

8-a hollow tube;

9-a pressurized interface;

10-a pressurizing cavity;

11-a guidewire interface;

12-development marking;

13-a monomer;

14-pressurized channel.

Detailed Description

The present inventors have conducted extensive and intensive studies and, through extensive screening, have developed an interatrial fistula-forming device for the first time. Compared with the prior art, the interatrial septum fistula-making device expands the main body by pressurizing the sac so as to fix the main body at the interatrial septum position. The pressurized liquid sac can expand the interatrial space while expanding the main body so as to expand the open state of the hole, so that the open state of the hole is kept for a longer time; the pressurizing sac can be well adapted to the atrial septum structure, so that the main body is completely attached to the atrial septum, the main body is more firmly fixed at the position of the atrial septum, and finally the effects of properly reducing the blood pressure in the left atrium, reducing the volume of the left atrium, relieving the symptoms of chronic heart failure, improving the function of the left heart and preventing the insufficiency of the left heart are realized.

The invention provides an interatrial septum fistula-making device, which is an interatrial septum fistula-making device with a specific structure.

Typically, the interatrial fistula-making device of the invention is composed of a main body, a pressurized liquid sac and optionally developing marks, wherein the main body is cut from a metal tube and is provided with a middle support ring and two side skirt structures, the middle support ring is provided with a limit ring, the middle support ring and the two side skirt structures are in a network structure, the diameter of the main body of the device is enlarged after the pressurized liquid sac is expanded, the two side skirt structures are outwards folded and form a certain angle with the central axis of the middle support ring, the developing marks are uniformly distributed in the circular holes at the two sides of the middle support ring and in the end circular holes of the grid structures of the two side skirt structures, and the surface of the main body of the.

In another preferred embodiment, the spacing rings in the middle support ring of the main body are distributed along the axial direction of the middle support ring in 2-6 rows, and the row spacing is 0.5-2 mm; preferably, the diameters of the limiting rings in each row after the pressurized liquid sac is expanded are equal, or the diameters of the limiting rings in each row are increased by 1-1.5 times from the middle to two sides.

In another preferred example, the main body is made by a laser cutting process, and the material is stainless steel, cobalt-chromium alloy, cobalt-nickel alloy or one of platinum, gold, palladium and tantalum or an alloy thereof.

In another preferred embodiment, the structure of the pressurizing liquid sac consists of 1-3 pressurizing sacs and a hollow tube, the outer diameter of the hollow tube is smaller than the inner diameter of the pressurizing sacs, the pressurizing sacs and the hollow tube are welded and closed at the distal end, a pressurizing cavity is formed between the pressurizing sacs and the hollow tube, the inner part of the hollow tube can be guided by a guide wire, and the specification of the guide wire is 0.010 'to 0.050'.

In another preferred example, the middle support ring network units of the main body are in a sine structure or a quadrilateral, hexagonal or octagonal structure, and the number of the middle support ring network units is 6-120; preferably 6-100, with 3-16 side skirt network elements.

In another preferred embodiment, the network unit of the middle support ring of the main body is provided with a spacing ring, so that the inner diameter of the middle support ring can be limited to a certain size after being expanded by the pressurizing liquid bag and cannot be increased continuously due to continuous change of the pressure of the pressurizing liquid bag.

In another preferred embodiment, after the main body is expanded by the pressurized liquid sac, the inner diameter of the middle supporting ring is 4-13mm, and the width of the supporting ring is 1.5-6 mm.

In another preferred embodiment, after the main body is expanded by the pressurized liquid sac, the height of the skirt parts at two sides is 2-8mm, and the maximum distance between the tail ends of the skirt parts at two sides is 3-12 mm.

In another preferred example, the developing marker material of the main body is one of platinum, gold, palladium, tantalum or an alloy thereof.

In another preferred embodiment, the developing marks of the main body are 3-30 in number and are connected to the main body of the apparatus by means of caulking or welding.

In another preferred embodiment, the surface of the body may be coated with an endothelialization inhibiting drug or an anticoagulant drug.

The main advantages of the invention include:

(a) the interatrial septum hole is further expanded through the pressurizing sac to expand the opening state of the hole, so that the opening state of the hole is kept longer, the stable existence of the artificial interatrial fistula is ensured, and the risk of secondary closure is avoided;

(b) the pressurized liquid sac can well adapt to the atrial septum structure, so that the expansion main body is completely attached to the atrial septum;

(c) the main body is adjusted to the optimal position and the expansion state through the pressurizing liquid bag;

(d) the operation is simple.

The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, the drawings are schematic and, thus, the apparatus and devices of the present invention are not limited by the size or scale of the schematic.

It is to be noted that in the claims and the description of the present patent, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, 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, the use of the verb "comprise a" to define an element does not exclude the presence of another, same element in a process, method, article, or apparatus that comprises the element.

Example 1

The interatrial septum ostomy device of this embodiment is shown in fig. 1-12 and is comprised of a main body and a pressurized fluid bladder.

The body is manufactured from a metal tube by means of a laser cutting process and comprises a support ring 1 and skirts 2 on both sides of the support ring 1. The support ring 1 comprises a support body 3 and a plurality of spacing rings 4. The main body is made of stainless steel, cobalt-chromium alloy, cobalt-nickel alloy or one of platinum, gold, palladium and tantalum or alloy thereof.

The support body 3 is a grid structure, and the grid structure unit of the support body can be, but is not limited to, a sine structure or a quadrilateral, hexagonal or octagonal structure; preferably square, rectangular, diamond, shuttle. In another preferred embodiment, one or more sides of the grid are curved, for example undulated, to provide a greater amount of deformation. The support body 3 can be expanded in the radial direction, even in the axial direction, on the basis of the lattice structure. The number of the grid structure units of the support body 3 is 6-120; preferably 6-100, which can be adjusted according to the actual requirements.

The retainer 4 is annular and perpendicular to the axial direction of the main body, and is used for limiting the expansion of the support body 3 in the radial direction, so that the expansion is not continuously increased due to the continuous change of the pressure of the pressurized liquid bag. The spacing ring 4 is an annular structure formed by splicing a plurality of straight sections and a plurality of bent sections in series end to end. The plurality of limiting rings 4 are uniformly arranged at intervals, and the intervals are 0.5-2 mm; preferably 0.7-1.5 mm. The number of the limiting rings 4 in the embodiment is 3, and the number can be adjusted according to actual requirements.

Each skirt 2 in this embodiment is flower-shaped. Each skirt 2 comprises 6 mutually independent single bodies 13, the single bodies 13 presenting a petaloid shape, evenly spaced around the circumference of the support body 3. The support ring 1 and the skirt 2 are integral or formed integrally. In the contracted state, each skirt portion 2 is folded in the axial direction of the body; in the expanded state, the two side skirts 2 are turned radially outwards around the two ends of the support ring 1, respectively.

The single bodies 13 of the single skirt 2 may have the same structure or may have different structures. The two skirt portions 2 may be of the same or different configurations, for example, the single body 13 of one skirt portion 2 is configured as shown in fig. 1, and the single body 13 of the other skirt portion 2 is configured as shown in fig. 6 a. The single body 13 of the skirt 2 may also be constructed as shown in fig. 6b-6c, i.e. without connecting struts in the middle of the single body. There is no particular limitation on the shape of the lattice structure of the skirt portion 2 as long as it can be easily turned over and can fix the main body to the atrial septal perforation.

The pressurized sac is used to expand the body. The number of the pressurizing bag bodies of the pressurizing liquid bag is 1, the length of the pressurizing bag body is 10-60mm, the shape of the pressurizing bag body after expansion can be cylindrical or dumbbell-shaped, when the pressurizing liquid bag is used, the main body is placed in the middle of the pressurizing bag body, after the main body is expanded by the pressurizing liquid bag, the pressurizing liquid bag is in the dumbbell-shaped after the main body is expanded due to the limiting effect of the limiting ring 4, and the two end parts of the pressurizing liquid bag are expanded and the skirt part 2 is turned over. The pressurizing sac is made of a polymer material, such as PU, TPU, PEBAX, nylon, or the like. The pressurizing liquid bag comprises a pressurizing bag body 5, a pressurizing bag body connecting pipe 6, a pressurizing liquid bag joint 7 and a hollow pipe 8. The pressurizing capsule body 5 is arranged at the far end of the pressurizing capsule body connecting pipe 6, the pressurizing liquid capsule joint 7 is arranged at the near end of the pressurizing capsule body connecting pipe 6, and the hollow pipe 8 is positioned in the pressurizing capsule body connecting pipe 6.

The outer diameter of the hollow tube 8 is smaller than the inner diameter of the pressurizing capsule connecting tube 6, the pressurizing capsule connecting tube 6 and the hollow tube 8 are welded and closed at the far end, a pressurizing cavity 10 is formed between the pressurizing capsule 5 and the hollow tube 8, and the pressurizing capsule 5 is pressurized and expanded through the pressurizing cavity 10. A pressurizing interface 9 and a guide wire interface 11 are respectively arranged at the proximal end of the pressurizing liquid bag joint 7, wherein the pressurizing interface 9 is communicated with the pressurizing cavity 10, preferably, the pressurizing interface 9 is communicated with the pressurizing cavity 10 through a connecting channel between the pressurizing bag body connecting pipe 6 and the hollow pipe 8, and the guide wire interface 11 is communicated with the hollow pipe 8. The interior of the hollow tube 8 may be guided by a guide wire. The gauge of the guidewire is 0.010 "to 0.050".

In the conveying process, the pressurizing liquid bag is in a contracted state, the main body is sleeved on the periphery of the pressurizing liquid bag and is also in a contracted state, as shown in fig. 4-5, wherein the support ring 1 and the skirt part 2 are attached to the peripheral wall of the pressurizing liquid bag, and the main body is conveyed through the pressurizing liquid bag.

When the pressure liquid bag is expanded, the pressure liquid bag is expanded to drive the main body sleeved on the periphery of the pressure liquid bag to expand, wherein the support ring 1 is radially expanded, and the turning angle alpha of the skirt part 2 is 30-120 degrees, preferably 30-90 degrees. The diameter of each row of stop collars 4 after the pressurized sac is expanded may be the same as shown in fig. 1-3 or may be different to better accommodate the atrial septal foramen structure. For example, the stop collars 4 of each row exhibit a gradient. For example, as shown in fig. 10-12, the diameter of the stop collar is increased by 1-1.5 times from the middle to both sides, that is, the diameter of the stop collar at the middle position after expansion is 1 unit, the diameter of the stop collar at both sides of the middle stop collar is 1.1 unit, and the interval between adjacent stop collars is 0.1 unit; it is also possible that the diameter of each row of stop collars 4 increases from side to side by 1-1.5 times. Or, the diameters of the stop collars 4 in each row do not change in a gradient manner, but do not change regularly, for example, 5 stop collars are provided, the diameter of the first stop collar after expansion is 1 unit, the diameter of the second stop collar after expansion is 1.1 unit, the diameter of the third stop collar after expansion is 1.4 unit, the diameter of the fourth stop collar after expansion is 1.2 unit, and the diameter of the fifth stop collar after expansion is 1 unit. In summary, each row of stop collars 4 may be expanded to have different proportions of diameter by the compression balloon 5 to accommodate the particular configuration of the interatrial fistula.

The skirt 2 may be turned over a small angle, for example 50 degrees, as shown in figure 7, or over a larger angle, for example 75 degrees, as shown in figure 2. The skirts 2 on both sides can be turned over at the same angle or at different angles. The single bodies 13 of the skirt portion 2 on the same side can be turned over by the same angle or by different angles. The turning condition of the skirt part 2 is determined by the structure of the interatrial septum, and the corresponding angle is turned by pressurizing through the hydraulic balloon so as to adapt to the specific structure of the interatrial septum.

After the pressurized liquid sac is expanded, the inner diameter of the support ring 1 is 4-13mm, and the axial length of the support ring 1 is 1.5-6 mm.

As shown in fig. 2, after the pressurized sac is expanded, the height h of the skirt parts 2 at both sides is 2-8mm, and the maximum distance s between the tail ends of the skirt parts 2 at both sides is 3-12 mm. The device of this embodiment is further provided with development marks 12, and the support ring 1 and the skirt 2 are provided with circular holes in which the development marks 12 are disposed. The material of the development mark 12 is one of platinum, gold, palladium, tantalum, or an alloy thereof.

The surface of the main body is coated with a drug for inhibiting endothelialization or an anticoagulant drug.

Example 2

The interatrial septum ostomy device of the present embodiment is similar to that of embodiment 1 except that the number of the pressurizing bladders 5 of the device of the present embodiment is 2, as shown in fig. 13, two pressurizing bladders are adjacently disposed in the axial direction, each pressurizing bladder has a length of 5-30mm, and is expanded to have a cylindrical, spherical or oval spherical shape; correspondingly, two pressurizing ports 9 are respectively arranged at the far ends of the pressurizing liquid bag joints 7, and the two pressurizing ports 9 are respectively communicated with the two pressurizing bag bodies 5 through two pressurizing channels in a fluid mode, so that the expansion and the contraction of the pressurizing bag bodies 5 are controlled. When the pressurizing bag body is used, the main body is placed in the middle of the 2 pressurizing bag bodies, the supporting ring expands along with the expansion of the main body along with the expansion of the pressurizing bag bodies, and the skirt portions on the two sides are turned upwards.

Example 3

The interatrial septum ostomy device of the present embodiment is similar to that of embodiment 1, except that the number of the pressurizing balloons of the device of the present embodiment is 3, as shown in fig. 14, three pressurizing balloons are adjacently disposed in sequence in the axial direction, the length of the distal pressurizing balloon is 5-30mm, the length of the proximal pressurizing balloon is 5-30mm, the length of the middle pressurizing balloon is 2-10mm, and the expanded shape thereof is cylindrical, spherical or oval-spherical; correspondingly, three pressurizing ports 9 are respectively arranged at the far ends of the pressurizing liquid bag joints 7, and the three pressurizing ports 9 are respectively communicated with the three pressurizing bags 5 through three pressurizing channels in a fluid mode, so that the expansion and the contraction of the pressurizing bags 5 are controlled. When 3 pressurization utricules and main part cooperation use, the support ring of main part is arranged in middle pressurization utricule, and the skirt section that is located the support ring both sides is arranged in the pressurization utricule of both sides, and the main part expands along with the pressurization utricule, and the support ring expands thereupon, and both sides skirt section upwards overturns. The arrangement of the three pressurizing channels 14 is shown in fig. 15a-15 c. In fig. 15a, a hollow tube 8 is arranged in the center of the pressurizing balloon connecting tube 6, and three pressurizing channels 14 are concentric with the hollow tube 8 and arranged layer by layer around the hollow tube 8. Fig. 15b shows a configuration in which the hollow tube 8 is disposed at the center of the pressurizing balloon connection tube 6, and three pressurizing channels 14 are uniformly distributed in a ring-shaped portion surrounded by the hollow tube 8 and the pressurizing balloon connection tube 6. Fig. 15c shows a configuration in which the hollow tube 8 is provided on one side of the pressurizing balloon connection tube 6 (i.e., eccentrically provided), and three pressurizing channels 14 are provided on the other side of the pressurizing balloon connection tube 6.

All documents referred to herein are incorporated by reference into this application as if each were individually incorporated by reference. Furthermore, it should be understood that various changes and modifications of the present invention can be made by those skilled in the art after reading the above teachings of the present invention, and these equivalents also fall within the scope of the present invention as defined by the appended claims.

Claims

1. An interatrial septum fistula-creating device, characterized in that said device comprises

The main body comprises a support ring and skirts positioned on two sides of the support ring, and is cut from a metal pipe; and

a pressurized bladder for expanding the body and inverting the skirt about the support ring;

in a first state, the pressurizing liquid bag is in a contracted state, the main body is sleeved on the periphery of the pressurizing liquid bag and is also in a contracted state, the support ring and the skirt portion are attached to the peripheral wall of the pressurizing liquid bag, and the main body is conveyed through the pressurizing liquid bag;

in the second state, the pressurizing liquid bag expands to drive the main body sleeved on the periphery of the pressurizing liquid bag to expand, wherein the support ring radially expands, and the turning angle alpha of the skirt part is 30-120 degrees.

2. The device of claim 1, wherein the support ring comprises a support body and optionally a plurality of retaining rings, the support body is of a lattice structure, and the retaining rings are annular and arranged perpendicular to the axial direction of the body.

3. The device of claim 2, wherein the stop collar is a ring-shaped structure formed by splicing a plurality of straight sections and a plurality of curved sections in series end to end.

4. The device of claim 2, wherein a plurality of said spacing collars are evenly spaced apart at intervals of 0.5-2 mm.

5. The device of claim 2, wherein the diameter of each row of the stop collar is equal after expansion of the pressurized fluid bladder.

6. The device of claim 2, wherein each row of said stop collars increases in diameter from the middle to each side by a factor of 1-1.5 after expansion by said pressurized sac.

7. The device according to claim 1, wherein the pressurizing sac comprises 1-3 pressurizing sacs, a pressurizing sac connecting pipe, a pressurizing sac connector and a hollow pipe, 1-3 pressurizing interfaces which are respectively communicated with the pressurizing sacs and are arranged at the far end of the pressurizing sac connector, wherein the pressurizing interfaces are in one-to-one correspondence with the pressurizing sacs, and 1 guide wire interface is used for being communicated with the hollow pipe.

8. The device of claim 7, wherein the pressurizing bladder is made of PU, TPU, PBAX, or nylon.

9. The device according to claim 7, wherein in the case that the number of said pressurizing capsules is 1, the length of said pressurizing capsule is 10-60mm, said body is placed in the middle of said pressurizing capsule;

in the case of a number of 2 said pressurizing bladders, two of them are arranged axially adjacent to each other, each of them having a length of 5-30mm, said body being placed in the middle of 2 of said pressurizing bladders;

in the case of a number of 3 said compression balloons, 3 said compression balloons are arranged axially one after the other, the distal one having a length of 5-30mm, the proximal one having a length of 5-30mm, the intermediate one having a length of 2-10mm, the support ring of the body being placed in the intermediate compression balloon, the skirts on the two sides of the support ring being placed in the compression balloons on the two sides.

10. The device of claim 1, wherein the device comprises a visualization mark, the visualization mark being attached to the body by means of an inlay or a weld.