CN116807545A - aneurysm treatment device - Google Patents

Abstract

The present invention relates to an aneurysm treatment device for implantation within an aneurysm, the aneurysm treatment device comprising: a balloon comprising a hollow balloon body, the balloon body being expandable or contractible, the balloon body having an opening, the balloon body being capable of entering into the aneurysm, the balloon body being capable of allowing filling or draining of contrast agent inside; the expansion assembly is arranged on the bag body and used for supporting the bag body and opening or closing the opening, and the bag body can be sealed when the opening is closed by the expansion assembly; when the capsule is filled with contrast agent, the capsule is inflated and the outer wall is capable of abutting at least a portion of the inner wall of the aneurysm; when the balloon is expelled from the contrast agent, the balloon contracts and the negative pressure acts to contract the aneurysm. Thus, the size of the aneurysm can be reduced after the operation, and the occupation of the aneurysm is avoided.

Description

Aneurysm treatment device

Technical Field

The invention relates to a medical surgical instrument, in particular to an aneurysm treatment instrument.

Background

Common vascular diseases include aneurysms, vascular ruptures, vascular perforations, vascular distensions, and the like. Aneurysms are the result of a local weakening of the wall of an arterial vessel due to disease, injury or congenital factors, where the weak point of the arterial vessel wall protrudes outward and gradually expands under the impact of blood flow, forming a circular, oval or prismatic balloon expansion. Aneurysms are a potentially life-threatening disease in which they grow continuously under the impact of blood flow, compressing surrounding organs or tissues to cause symptoms; abrupt bleeding occurs due to rupture of the aneurysm caused by increased blood pressure or other factors. Aneurysms can occur in different parts of the body, the most common being abdominal aortic aneurysms and intracranial aneurysms.

Intracranial aneurysms are a highly pathogenic and fatal cerebrovascular disease, and are mostly found in the bifurcation of the cerebral bottom artery due to congenital defects in the wall of the cerebral artery and increased pressure in the lumen of the cerebral artery. When the aneurysm breaks, the meninges are stimulated by severe headache, dysphoria, nausea, vomiting and the like, and then the intracranial pressure is increased, and the life can be endangered when the illness is serious. Aneurysms are a major cause of subarachnoid hemorrhage.

With the advancement of medical technology, the development of materials for instruments, and the accumulation of experience of the interventional nerve practitioner, endovascular treatment has become the treatment of choice for reducing the rate of revascularization and mortality of ruptured aneurysms. Among the most widely used treatments are aneurysm coil embolization, which is a process of dense embolization of coils into an aneurysm to affect intratumoral hemodynamics, promoting thrombosis in the aneurysm, and blood flow guiding device treatment; the blood flow guiding device directly prevents blood from flowing into the aneurysm body by forming a blood flow barrier at the neck of the aneurysm, so that thrombus is gradually formed in the aneurysm body, and the purpose of treating the aneurysm is achieved.

However, the clinical effects of the two main treatment methods are that the aneurysm still keeps the inherent size, thrombus and organized tissues are formed in the aneurysm, the volume of the aneurysm can keep the inherent size in the middle period after operation and even in the long period after operation, and the clinical occupation effect of continuously pressing nerves, blood vessels and organs outside the aneurysm exists clinically.

Disclosure of Invention

Based on this, there is a need to provide an aneurysm treatment device capable of reducing the inherent size of the postoperative aneurysm, in view of the problem of the existing placeholder effect of the aneurysm remaining fixed in size after the aneurysm operation.

An aneurysm treatment device for implantation within an aneurysm, the aneurysm treatment device comprising:

a balloon comprising a hollow balloon body, the balloon body being expandable or contractible, the balloon body having an opening, the balloon body being capable of entering into the aneurysm, the balloon body being capable of allowing filling or draining of contrast agent inside; and

the expansion assembly is arranged on the bag body and used for supporting the bag body and opening or closing the opening, and the bag body can be sealed when the opening is closed by the expansion assembly;

when the capsule is filled with contrast agent, the capsule is inflated and the outer wall is capable of abutting at least a portion of the inner wall of the aneurysm; when the balloon is expelled from the contrast agent, the balloon contracts and the negative pressure acts to contract the aneurysm.

In one embodiment, the expansion assembly includes an expansion bracket capable of contracting or expanding, the expansion bracket is in contact with the balloon, the expansion bracket can drive the balloon to expand or the contrast agent is filled into the balloon to expand the balloon, so that an opening of the balloon is exposed, the sealing bracket is at least partially connected with the expansion bracket and is capable of opening or closing the opening, and the sealing bracket can seal the balloon when closing the opening.

In one embodiment, the expansion bracket is arranged inside the bag body, and the expansion bracket is abutted with the inner surface of the bag body.

In one embodiment, the expansion bracket is disposed on the exterior of the balloon, the expansion bracket being in contact with the exterior surface of the balloon.

In one embodiment, the expansion bracket comprises a first end and a second end, the first end and the second end are respectively positioned at two ends of the expansion bracket, the radial dimension of the first end is larger than that of the second end, the expansion bracket after expansion is in a flaring structure, and the second end is in contact with the edge of the opening of the bag body.

In one embodiment, the expanded stent conforms to the balloon when the expanded stent is expanded.

In one embodiment, the expansion stent is only partially conformable to the balloon.

In one embodiment, the expansion bracket is a net structure formed by intersecting and braiding a plurality of braided wires;

alternatively, the expanded stent is cut from a metal tube having self-expansibility.

In one embodiment, each of the braided filaments is shaped as a straight line, a curve, or a combination of straight and curve.

In one embodiment, the expansion bracket is made of a resilient metallic material;

alternatively, the expansion stent is made of non-elastic memory metal, and the contrast medium filled in the balloon expands the balloon.

In one embodiment, the expansion stent is made of at least one of nickel titanium alloy, nitinol, stainless steel, cobalt chromium alloy, nickel cobalt alloy, and stretch filled tube.

In one embodiment, the radial dimension of the closure mount is greater than the radial dimension of the opening.

In one embodiment, the opening is circular;

the closed support is round, or the closed support is provided with an inscribed circle;

the diameter of the closed bracket is 1.2-1.5 times of the diameter of the opening.

In one embodiment, the closed stent is formed from a plurality of braided filaments; alternatively, the closure bracket is formed by laser engraving.

In one embodiment, the balloon further comprises a cover film covering the closed stent, the cover film sealing the opening when the closed stent closes the opening.

In one embodiment, the balloon is a dense, watertight structure.

In one embodiment, the balloon is made of a non-degradable polymeric material.

In one embodiment, the balloon is made of polytetrafluoroethylene, polyurethane, or polyethylene.

In one embodiment, the aneurysm treatment device further comprises a catheter for filling the interior of the balloon with a contrast agent;

the catheter remains extended from the opening until the balloon is inflated.

After the technical scheme is adopted, the invention has at least the following technical effects:

when the aneurysm therapeutic apparatus is used, the catheter is stretched into the bag body through the opening, then the whole aneurysm therapeutic apparatus and the catheter stretched into the aneurysm therapeutic apparatus are placed into the conveying pipe, the aneurysm therapeutic apparatus is conveyed into the aneurysm through the conveying pipe, and the expansion assembly can support the bag body. Subsequently, contrast medium can be injected into the balloon through the catheter, during which the balloon is gradually inflated to continuously squeeze out blood from the aneurysm; when the capsule body touches the inner wall of the aneurysm, filling contrast agent into the capsule body continuously until the shape of the capsule body is consistent with the shape of the tumor cavity of the aneurysm, so that the tumor cavity is basically free of blood; then the contrast medium in the capsule is sucked through the catheter, in the process of discharging the contrast medium out of the capsule, the negative pressure generated between the capsule and the aneurysm can drive the aneurysm to shrink, when the capsule and the aneurysm are attached to the expansion assembly, the catheter is drawn out, and the opening is closed through the expansion assembly, so that blood is prevented from flowing back into the aneurysm. According to the aneurysm treatment device, the bag body is supported by the expansion assembly, and the expansion and contraction of the bag body are realized by injecting or sucking the contrast agent into the bag body, so that the negative pressure generated when the bag body is contracted during sucking drives the aneurysm to contract, the size of the aneurysm after operation is reduced, and the occupation effect of the aneurysm is reduced.

Drawings

FIG. 1 is a perspective view of an aneurysm treatment device according to an embodiment of the present invention;

FIG. 2 is a front view of the aneurysm treatment device shown in FIG. 1;

FIG. 3 is a side view of the aneurysm treatment device shown in FIG. 1;

FIG. 4 is a perspective view, from an angle, of the aneurysm treatment device of FIG. 1 mated with a catheter;

FIG. 5 is a perspective view of the aneurysm treatment device of FIG. 4 mated with a catheter from another perspective;

FIG. 6 is a perspective view of the closure stent closure of the expansion assembly of the aneurysm treatment device shown in FIG. 1;

FIG. 7 is a front view of the closure bracket of the crash assembly shown in FIG. 6 closed;

FIG. 8 is a bottom view of the closure bracket of the expansion assembly of FIG. 6 closed;

FIG. 9 is an open perspective view of a closure stent of an inflation assembly of the aneurysm treatment device of FIG. 1;

FIG. 10 is a front view of the impact assembly of FIG. 9 with the closure bracket open;

FIG. 11 is a bottom view of the expansion assembly of FIG. 9 with the closure bracket open;

FIG. 12 is a side view of the expansion assembly of FIG. 9 with the closure bracket open;

fig. 13 is a process diagram of implantation of the aneurysm treatment device shown in fig. 1.

Wherein: 100. an aneurysm treatment device; 110. a balloon; 111. a bladder; 1111. an opening; 112. a cover film; 120. an expansion assembly; 121. an expansion stent; 122. closing the bracket; 200. an aneurysm; 210. a tumor cavity; 300. a catheter.

Detailed Description

In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.

In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

Referring to fig. 1-5, the present invention provides an aneurysm treatment device 100. The aneurysm treatment device 100 can be implanted into an aneurysm 200, so that the aneurysm 200 can be reduced after operation, and the occupation of the aneurysm 200 can be reduced. It is understood that the aneurysm 200 herein may be an intracranial aneurysm, a celiac aneurysm, a carotid aneurysm, etc. In the present invention, the aneurysm 200 is described as an example in which the aneurysm treatment device 100 is applied to the intracranial aneurysm 200, and the principle of the aneurysm treatment device 100 applied to other portions of the aneurysm 200 is substantially the same as that of the intracranial aneurysm 200, and will not be described in detail herein.

It will be appreciated that it is now common for aneurysms to be treated by thrombus formation or flow of blood from the aneurysm. However, after the treatment, the aneurysm often still keeps the inherent size, and the volume of the aneurysm in the middle and long term after operation keeps the inherent size, so that the space occupying effect exists, and further, the potential safety hazard exists.

To this end, the present invention provides a novel aneurysm treatment device 100. After the aneurysm 200 is implanted in the aneurysm treatment device 100, blood in the aneurysm 200 can be discharged when the aneurysm treatment device expands, and the aneurysm 200 can be driven to shrink when the aneurysm treatment device contracts, so that the volume of the aneurysm 200 is reduced, and the occupation effect of the aneurysm 200 is avoided. The specific structure of the aneurysm treatment device 100 is described in detail below.

Referring to fig. 1-5, in one embodiment, an aneurysm treatment device 100 comprises a balloon 110 and an inflation assembly 120. Balloon 110 includes a hollow balloon 111, the balloon 111 being expandable or contractible, the balloon 111 having an opening 1111, the balloon 111 being capable of entering the aneurysm 200, the balloon 111 being capable of allowing filling or draining of contrast agent inside. An expansion assembly 120 is disposed on the bladder 111, the expansion assembly 120 is used for supporting the bladder 111 and opening or closing the opening 1111, and the expansion assembly 120 can seal the bladder 111 when closing the opening 1111. When the balloon 111 is filled with contrast agent, the balloon 111 expands and the outer wall abuts at least part of the inner wall of the aneurysm 200; when the balloon 111 expels the contrast agent, the balloon 111 contracts and the aneurysm 200 is contracted by the action of negative pressure.

Balloon 110 is the inflation and deflation component of aneurysm treatment device 100, with balloon 110 driving aneurysm 200 to deflate. The balloon 110 includes a balloon body 111, the balloon body 111 has a hollow structure, the balloon body 111 has an opening 1111, and the opening 1111 can communicate with the inside and outside environment of the balloon body 111. Thus, in practice, the catheter 300 is first inserted into the balloon 111 through the opening 1111 of the balloon 111, then the catheter 300, the balloon 111 and the inflation assembly 120 are placed in a larger delivery tube, the balloon 111 of the balloon 110 is delivered to the inside of the aneurysm 200 through the delivery tube, then the delivery tube is removed, and the contrast medium is injected and discharged through the catheter 300 into the balloon 111. The injection of contrast agent into the balloon 111 causes the balloon 111 to assume a substantially spherical shape when the balloon 111 is inflated. When the balloon 111 conforms to the inner wall of the aneurysm 200, the shape of the balloon 111 conforms to the shape of the lumen 210 of the aneurysm 200. That is, the shape of the inflated balloon 111 can adapt to the shape of the tumor cavity 210, so that the balloon 111 drives the aneurysm 200 to shrink synchronously.

The expansion assembly 120 is disposed on the bladder 111, and the expansion assembly 120 can expand or contract. Inflation assembly 120 is capable of expanding the balloon when inflated such that opening 1111 of balloon 111 is exposed, facilitating insertion of catheter 300 into balloon 111 through opening 1111; further, the inflation assembly 120 allows the balloon 111 to occupy a space when the balloon 111 is deployed in the aneurysm 200, facilitating filling of the catheter 300 with contrast medium within the balloon 111. It should be noted that, the expansion assembly 120 is capable of self-expanding without an external force, and the expansion assembly 120 is capable of contracting when the external force acts on the expansion assembly 120. By virtue of the inflation and deflation characteristics of inflation assembly 120, a healthcare worker can conveniently deliver inflation assembly 120 and balloon 110 into aneurysm 200 via a delivery tube.

Referring to fig. 1 to 5 and 13, specifically, the expansion module 120 and the balloon 111 are folded and contracted by an external force, and placed in a delivery tube, and the contracted expansion module 120 and the balloon 111 of the connection catheter 300 are delivered into the aneurysm 200 through the delivery tube. After inflation assembly 120 is decoupled from balloon 111, inflation assembly 120 is self-expanding, and balloon 111 can be filled with contrast media via catheter 300.

When contrast medium is injected into the balloon 111 through the catheter 300, the contrast medium gradually fills the balloon 111, so that the balloon 111 gradually expands, and in the process, the balloon 110 occupies the space inside the aneurysm 200, and blood in the tumor cavity 210 of the aneurysm 200 is continuously squeezed out, so that at least part of the balloon 111 touches the inner wall of the aneurysm 200. Subsequently, the contrast agent is continuously filled into the capsule 111, so that the volume of the capsule 111 is continuously enlarged, and blood in the tumor cavity 210 is continuously squeezed out. When the morphology of the balloon 111 is nearly identical to the morphology of the tumor cavity 210, the balloon 111 and the inflation assembly 120 form an adherent barrier, and there is no blood in the tumor cavity 210.

The contrast agent in the balloon 111 is then aspirated through the catheter 300, and the volume of the balloon 111 is continuously reduced as the contrast agent is continuously aspirated. Because negative pressure is formed between the outer surface of the balloon 111 and the inner wall of the aneurysm 200, the aneurysm 200 is driven to shrink during the shrinking process of the balloon 111. When the catheter 300 has completely aspirated the contrast agent in the balloon 111, the negative pressure can cause the balloon 111 to contract and attach to the inflation assembly 120, as well as the aneurysm 200 to contract such that the inner wall of the aneurysm 200 attaches to the outer wall of the balloon 111. Thereafter, the catheter 300 is removed and the inflation assembly 120 can occlude the opening 1111, forming a closure, preventing blood from entering the tumor cavity 210.

According to the aneurysm treatment device 100 disclosed by the invention, the inflation assembly 120 supports the balloon 111 of the balloon 110, so that on one hand, the balloon 111 can be unfolded, the catheter 300 can be conveniently stretched into the balloon 111 to facilitate later filling of contrast medium, and on the other hand, the inflation assembly 120 can also support the balloon 111 to ensure the shape of the balloon 111 when the balloon 111 is sucked, so that the aneurysm 200 can be conveniently driven to shrink synchronously. When the contrast medium is injected into the balloon 111 through the catheter 300, the contrast medium can gradually expand the balloon 111 and contact the inner wall of the aneurysm 200 until the outer surface of the balloon 111 completely contacts the inner wall of the aneurysm 200; the contrast medium in the balloon 111 is then withdrawn through the catheter 300, so that the balloon 111 is continuously contracted, and the aneurysm 200 can be driven to synchronously contract when the balloon 111 is contracted. When fully aspirated, the balloon 111 can be attached to the inflation assembly 120, and the aneurysm 200 is attached to the outer surface of the balloon 111, thereby reducing the volume of the aneurysm 200 and thus the placeholder effect of the aneurysm 200.

Referring to fig. 1 to 3 and 6 to 12, in an embodiment, the expansion assembly 120 includes an expansion bracket 121 and a closing bracket 122, the expansion bracket 121 is capable of contracting or expanding, the expansion bracket 121 contacts the balloon 111, the expansion bracket 121 can drive the balloon 111 to expand or the contrast agent is filled into the balloon 111 to expand the balloon 111 when expanding, so that an opening 1111 of the balloon 111 is exposed, the closing bracket 122 is at least partially connected with the expansion bracket 121 and opens or closes the opening 1111, and the closing bracket 122 can seal the balloon 111 when closing the opening 1111.

The expansion bracket 121 is a supporting member of the expansion assembly 120, and the balloon 111 is supported by the expansion bracket 121. Specifically, after the balloon 111 enters the aneurysm 200, the expansion stent 121 can expand the balloon 111, so that the balloon 111 occupies a certain space in the aneurysm 200, and is convenient for later filling with the contrast agent. After the catheter 300 has been used to aspirate contrast medium from the balloon 111, the stent 121 also supports the balloon 111 and aneurysm 200 attached thereto so that the balloon 111 covering the neck of the aneurysm remains in its original expanded state.

At least a portion of the closure stent 122 is connected to the expansion stent 121. The closing bracket 122 can close the opening 1111 without an external force, and when the external force acts on the closing bracket 122, the closing bracket 122 can be far away from the opening 1111, and the opening 1111 is opened. When the external force is eliminated, the closing bracket 122 can reset under the action of the acting force of the self material, so as to close the opening 1111, and ensure the tightness of the capsule 111.

Specifically, prior to implantation of the aneurysm 200 with the aneurysm treatment device 100, the sealing stent 122 is pulled through the catheter 300 such that the sealing stent 122 opens the opening 1111, whereupon the catheter 300 is able to extend through the opening 1111 into the interior of the balloon 111. After balloon 111 of connecting catheter 300 and inflation assembly 120 are delivered into aneurysm 200 by the delivery catheter, inflation stent 121 is capable of self-expanding, i.e., inflation stent 121 is capable of being at least partially expanded such that inflation stent 121 is capable of expanding balloon 111 partially. Subsequently, a contrast agent is injected into the balloon 111 through the catheter 300. After the catheter 300 has been used to aspirate contrast medium, and the catheter 300 has been removed from the opening 1111 and the sealing stent 122 has been repositioned under its own material forces to close the opening 1111 and prevent blood and the like from entering the balloon 111.

Of course, in other embodiments of the present invention, the expansion stent 121 may not have the expansion property, and at this time, the contrast agent is filled into the balloon 111, so that the balloon 111 is expanded. The principle of inflation of the capsule 111 by the contrast medium into the capsule 111 is substantially the same as the principle of self-inflation of the capsule 111 described above, and will not be described in detail here. Alternatively, the expansion bracket 121 is cut from non-elastic memory metal, and the bladder 111 is inflated by filling with a contrast medium, so as to drive the expansion bracket 121 to expand. In this embodiment, the expansion stent 121 only plays a role in supporting the opening of the balloon at the neck opening of the tumor to seal the neck opening of the tumor.

Referring to fig. 1 to 3 and 6 to 12, in one embodiment, the expansion bracket 121 is disposed inside the balloon 111 and is located at the bottom of the balloon 111 in the figure, that is, at the position of the neck of the tumor, and the expansion bracket 121 abuts against the inner surface of the balloon 111. That is, the expansion bracket 121 is disposed inside the balloon 111, i.e., the balloon 111 is wrapped around the outside of the expansion bracket 121.

After the aneurysm 200 is fed through the delivery tube after occlusion and contraction of the aneurysm treatment device 100, the expansion stent 121 self-expands inside the balloon 111, and the expansion stent 121 abuts against the inner wall of the balloon 111 to expand the balloon 111. Also, when the suction of the contrast agent in the balloon 111 is completed, the inner wall of the balloon 111 is fitted to the expansion stent 121, and the inner wall of the aneurysm 200 is fitted to the outer wall of the balloon 111.

Optionally, the expansion stent 121 is at least partially secured to the inner wall of the balloon 111. Optionally, an expansion stent 121 is located at the bottom of balloon 111, i.e., at the location of the tumor neck, and around opening 1111. Thus, after the contrast agent in the capsule 111 is sucked, the support at the bottom can make the capsule 111 and the aneurysm 200 attached to the support, so that the capsule 111 can drive the aneurysm 200 to shrink, and the aneurysm 200 is prevented from occupying. Optionally, the expansion stent 121 is secured in the balloon 111 by gluing or the like. Of course, the expansion bracket 121 may also be freely disposed in the balloon 111.

Referring to fig. 1 to 3 and 6 to 12, in one embodiment, the expansion bracket 121 is disposed outside the balloon 111 and is located at the bottom of the balloon 111, i.e., at the location of the neck of the tumor, in the figures, and the expansion bracket 121 is in contact with the outer surface of the balloon 111. That is, the expansion stent 121 is disposed outside of the balloon 111, i.e., the expansion stent 121 at least partially encloses the balloon 111.

After the aneurysm 200 is fed through the delivery tube after the occlusion and contraction of the aneurysm treatment device 100, the expansion stent 121 self-expands on the outer side of the balloon 111, and the expansion stent 121 can drive the balloon 111 to expand, so that the balloon 111 is partially expanded. Moreover, when the suction of the contrast agent in the balloon 111 is completed, the balloon 111 is attached to the expansion bracket 121 in a double-layered structure, and the inner wall of the aneurysm 200 is attached to the outer wall of the balloon 111.

Optionally, the expansion stent 121 is at least partially secured to the outer wall of the balloon 111. Alternatively, the expansion bracket 121 is located at the bottom of the balloon 111 and on the circumferential side of the opening 1111. Thus, after the contrast agent in the balloon 111 is sucked, the bottom expansion stent 121 can make the balloon 111 and the aneurysm 200 attached to the expansion stent 121, so that the balloon 111 can drive the aneurysm 200 to shrink, and the aneurysm 200 is prevented from occupying. Optionally, the expansion stent 121 is secured in the balloon 111 by gluing or the like.

It should be noted that, the working principle of the expansion bracket 121 inside the balloon 111 is substantially the same as that of the expansion bracket outside the balloon 111, and in the present invention, only the inner wall of the balloon 111 is taken as an example for illustration, and other details are not repeated.

Referring to fig. 1 to 3 and fig. 6 to 12, in an embodiment, the expansion bracket 121 includes a first end and a second end, the first end and the second end are respectively located at two ends of the expansion bracket 121, the radial dimension of the first end is greater than that of the second end, so that the expansion bracket 121 after expansion has a flaring structure, and the second end contacts with an edge of the opening 1111 of the capsule 111.

The radial dimension of the first end is larger, and the radial dimension of the second end is smaller, so that the expanded shape of the expansion bracket 121 is a flaring structure, as shown in fig. 6, that is, the radial dimension of the upper end is larger, and the radial dimension of the lower end is smaller. The expansion bracket 121 has two opposite ends, namely a first end and a second end, wherein the first end is a flared end, the second end is a narrow end, and the expansion bracket 121 is smoothly connected with the first end and the second end, so that the shape of the contact part between the balloon 111 and the expansion bracket 121 is consistent, and the balloon 111 is conveniently attached to the inner wall of the aneurysm 200.

The first end of the expansion bracket 121 is located at the middle position of the balloon 111, the second end of the expansion bracket 121 is located at the edge of the opening 1111 of the balloon 111, after the balloon 111 is expanded, the first end of the expansion bracket 121 can expand the inside of the balloon 111 by a part, and the closing bracket 122 closes the opening 1111. In this way, when the contrast medium is filled into the balloon 111, the catheter 300 is used to pull the closing stent 122 so that the opening 1111 is opened by the closing stent 122, the catheter 300 is inserted into the balloon 111 through the opening 1111, the balloon 111 and the expansion stent 121 are then conveyed to the aneurysm 200 by the conveying pipe, and when the conveying pipe is removed, the contrast medium is injected into the balloon 111 by the catheter 300.

In one embodiment, the longitudinal section and the axial shape of the expansion bracket 121 are arranged in an arc shape. That is, the expanded shape of the expanded stent 121 is a portion of a sphere. This can facilitate the attachment of the balloon 111 to the inner wall of the aneurysm 200.

Referring to fig. 1-3 and 6-12, in one embodiment, the expansion stent 121 is a mesh structure formed by intersecting a plurality of braided wires. The plurality of braided wires are interlaced to form a mesh structure, and the interstices in the mesh structure can accommodate contraction of the braided wires, thereby effecting contraction of the expansion stent 121. In this way, the expansion stent 121 can be contracted under the action of external force, so that the expansion stent 121 can conveniently enter the delivery tube and then be delivered to the interior of the aneurysm 200 by the delivery tube.

In one embodiment, each braided wire is shaped as a straight line, a curve, or a combination of straight and curve. That is, the braided wires employed in the expansion stent 121 may all be linear. The linear type braided wires can be staggered horizontally and longitudinally or obliquely. Alternatively, the braided filaments of the expanded stent 121 may all be curvilinear. The protrusions of the curved braided wires may be arranged in the same direction, or may be partially oriented in the same direction, and the other portion may be oriented in another direction, so that the expansion bracket 121 is formed by interlacing. Of course, in other embodiments of the present invention, some of the braided filaments may be curved and some may be linear.

In the present invention, the shape of the braided wires of the expansion bracket 121 is arc-shaped, and the arc-shaped braided wires are staggered with the braided wires facing opposite directions to form a mesh structure.

In one embodiment, the expansion stent 121 conforms to the balloon 111 as the expansion stent 121 expands. That is, when the expansion stent 121 is expanded, the expansion stent 121 covers the surface of the balloon 111. Of course, in other embodiments of the invention, the expansion stent 121 is only partially attached to the balloon 111. That is, the expansion stent 121 covers only a part of the surface of the balloon 111 after expansion.

In one embodiment, the expansion stent 121 is cut from a metal tube having self-expansion properties. That is, the mesh structure, that is, the expansion bracket 121, may be formed by cutting a self-expandable metal tube so that the expansion bracket 121 can be contracted by an external force and self-expanded when the external force is removed.

In one embodiment, the expansion bracket 121 is made of a resilient metallic material. This enables the expansion stent 121 to compress and self-expand. Specifically, when an external force is applied to the expansion stent 121, the characteristics of the elastic metal material enable the expansion stent 121 to contract, and at this time, the expansion stent 121 can enter the delivery tube and be delivered into the aneurysm 200 by the delivery tube. When the external force of the expansion bracket 121 is eliminated, the elastic bracket can be self-expanded due to the characteristics of the elastic metal material, the expansion bracket 121 is gradually stretched and expanded, and at this time, the expansion bracket 121 can open the balloon 111, so that the balloon 111 is expanded.

In one embodiment, the expansion stent 121 is made of at least one of nitinol, stainless steel, cobalt chrome alloy, nickel cobalt alloy, and stretch filled tube (DFT, drawn Filled Tubing), etc. That is, the elastic metal material includes at least one of nitinol, stainless steel, cobalt chrome alloy, nickel cobalt alloy, and stretch filled tube, etc., to ensure that the expansion bracket 121 has a self-expanding characteristic. Of course, in other embodiments of the present invention, the expansion bracket 121 may be made of other materials having elastic properties.

Referring to fig. 1-3 and 6-12, in one embodiment, the radial dimension of the closure bracket 122 is greater than the radial dimension of the opening 1111. That is, the closing stent 122 can completely cover the opening 1111, ensure the tightness of the balloon 111, prevent blood and the like from entering the balloon 111, and ensure the reduced shape of the aneurysm 200 to remain unchanged.

Referring to fig. 1-3 and 6-12, in one embodiment, the opening 1111 is circular. The closing bracket 122 is circular, or the closing bracket 122 has an inscribed circle. That is, opening 1111 is circular in shape, and opening 1111 has a diameter slightly larger than that of catheter 300, facilitating insertion of catheter 300 into balloon 111 through opening 1111. The shape of the closing bracket 122 is not limited in principle as long as the opening 1111 can be closed. Alternatively, the shape of the closing bracket 122 may be a circle or a structure capable of covering the opening 1111.

In one embodiment, the diameter of the closing bracket 122 is 1.2-1.5 times the diameter of the opening 1111. That is, the area of the closing bracket 122 is larger than the area of the opening 1111, so that the closing bracket 122 can reliably close the opening 1111, ensuring the sealability of the capsule 111.

Referring to fig. 1-3 and 6-12, in one embodiment, the closure stent 122 is a mesh structure woven from a plurality of braided filaments. The plurality of braided filaments are interlaced to form a mesh structure, and voids in the mesh structure can accommodate contraction of the braided filaments, thereby effecting contraction of the closed stent 122. In this way, the sealing stent 122 can be contracted under the action of external force, so that the sealing stent 122 can conveniently enter the delivery tube and then be delivered to the interior of the aneurysm 200 by the delivery tube.

In one embodiment, each braided wire is shaped as a straight line, a curve, or a combination of straight and curve. That is, the braided filaments used for the occluding stent 122 may all be linear. The linear type braided wires can be staggered horizontally and longitudinally or obliquely. Alternatively, the braided filaments of the closure stent 122 may all be curvilinear. The protrusions of the curved braided wires may be arranged in the same direction, or may be partially oriented in the same direction, and the other portion may be oriented in another direction, so that the expansion bracket 121 is formed by interlacing. Of course, in other embodiments of the present invention, some of the braided filaments may be curved and some may be linear.

In the present invention, the shape of the braided wires is linear, and each braided wire is crisscrossed transversely and longitudinally to form a dense net structure, namely the closed support 122.

In one embodiment, the closure mount 122 is formed by laser engraving. That is, the closed support 122 is formed by laser processing to form a dense net structure.

In one embodiment, the closure bracket 122 is made of a resilient metallic material. This enables the closed stent 122 to compress and self-expand. Specifically, when an external force is applied to the stent 122, the characteristics of the elastic metal material can cause the stent 122 to contract, at which time the stent 122 can enter the delivery tube and be delivered into the aneurysm 200 by the delivery tube. When the external force of the closing bracket 122 is removed, the characteristic of the elastic metal material can cause the elastic bracket to self-expand, and the closing bracket 122 gradually expands, at which time the closing bracket 122 can close the opening 1111. Also, when the catheter 300 toggles the closure bracket 122, the closure bracket 122 can open the opening 1111 under an external force such that the catheter 300 protrudes into the balloon 111 through the opening 1111. When catheter 300 is removed, the resilient metallic material properties enable the occlusive stent 122 to be automatically reset to close the opening 1111, effecting a seal of the balloon 111.

In one embodiment, the closure stent 122 is made of at least one of nitinol, stainless steel, cobalt chrome, nickel cobalt alloy, and stretch filled tube (DFT, drawn Filled Tubing). That is, the elastic metal material includes at least one of nitinol, stainless steel, cobalt chrome, nickel cobalt, and stretch filled tube, etc. (DFT, drawn Filled Tubing) to ensure the self-expanding nature of the closure stent 122. Of course, in other embodiments of the present invention, the closing bracket 122 may be made of other materials having elastic properties.

Referring to fig. 1 to 3 and 6 to 12, in an embodiment, the balloon 110 further includes a cover film 112, the cover film 112 covers the closing bracket 122, and when the closing bracket 122 closes the opening 1111, the cover film 112 seals the opening 1111. The cover film 112 can cooperate with the balloon 111 to form the complete balloon 110. The cover film 112 may cover the outside or the inside of the closing bracket 122, and when the closing bracket 122 closes the opening 1111, the cover film 112 is also covered on the opening 1111, so as to ensure the tightness of the capsule 111.

Of course, in other embodiments of the invention, the sealing of opening 1111 may also be accomplished by closing bracket 122 alone. It will be appreciated that the closed stent 122 is a dense mesh structure, and the opening 1111 can be closed by a sealing structure, so as to avoid blood and the like from entering.

In one embodiment, the balloon 110 is a dense, watertight structure. This can avoid blood entering the balloon 110, so that blood can only be discharged through the space between the balloon 110 and the inner wall of the aneurysm 200, and can be extruded out of the aneurysm 200 when the balloon 110 is inflated, and can also ensure that the aneurysm 200 is driven to shrink when the balloon 110 is contracted.

In one embodiment, the balloon 110 is made of a non-degradable polymeric material. Thus, the shape of the bag body 111 can be ensured to keep a contracted state, the degradation of the bag body 111 is avoided, the aneurysm 200 is prevented from recovering the original size, and the occupation effect of the aneurysm 200 is effectively avoided.

In one embodiment, the balloon 110 is made of polytetrafluoroethylene, polyurethane, polyethylene, or the like. Of course, in other embodiments of the present invention, balloon 110 may be made of other non-degradable polymeric materials, so long as blood is prevented from entering balloon 111.

In one embodiment, the aneurysm treatment device 100 further comprises a catheter 300 for filling the interior of said balloon 111 with a contrast agent; the catheter 300 remains extended from the opening until the balloon 111 is inflated. Before inflation of the balloon 111, the catheter 300 extends into the balloon through the opening so that contrast agent can enter the balloon 111 through the catheter 300.

Referring to fig. 13, the aneurysm treatment device 100 of the present invention is used in the following manner:

before the aneurysm treatment device 100 is implanted in a human body, the bottom occlusion stent 122 is expanded by the catheter 300, and then the catheter 300 is passed through the opening 1111 of the balloon 111 and the second end of the expansion stent 121 into the interior of the balloon 111 of the balloon 110. The entire implantation instrument may be delivered into the aneurysm 200 via a larger delivery tube.

Referring to fig. 13 (a) - (c), the first stage is the balloon 110 filling stage. At this stage, the aneurysm treatment device 100 is first placed within the lumen 210 of the aneurysm 200 near the top of the aneurysm and then contrast medium is injected through the catheter 300 so that the balloon 110 is continuously inflated. As the thin film balloon 110 continues to expand, blood within the tumor cavity 210 is continually expressed. After balloon 110 contacts the wall of aneurysm 200, the thin film shape of balloon 110 conforms to the morphology of tumor cavity 210, and the injection of contrast media into balloon 110 continues. Under the auxiliary observation of the image equipment, along with the continuous expansion of the volume of the balloon 110 in the tumor cavity 210, the aneurysm treatment device 100 is slowly moved downwards, so that blood is continuously extruded out of the tumor cavity 210, and simultaneously the filled balloon 110 gradually accords with the shape of the tumor cavity 210, at the moment, the expansion bracket 121 is completely released, at the moment, the balloon 110 and the expansion bracket 121 form an adherence barrier, and no blood exists in the tumor cavity 210.

Referring to fig. 13 (d) to (f), the second stage is a suction stage. The volume of balloon 110 is continually reduced as contrast agent is continually aspirated by aspiration of balloon 110 through catheter 300. During deflation of balloon 110, a negative pressure is created between the outer surface of balloon 111 and the inner wall of lumen 210, causing subsequent deflation of aneurysm 200. When the catheter 300 completely sucks the contrast agent inside the balloon 110, the balloon 110 is contracted and attached to the inner surface of the reducing stent, and the aneurysm 200 is also contracted until the wall inside the aneurysm is attached to the outer surface of the balloon 111.

Referring to fig. 13 (e), the third stage is the release stage. After the second stage is completed, the catheter 300 is withdrawn, and then the occluding stent 122 is retracted and able to block the impact of blood in the parent artery, the occluding stent 122 conforming to block the opening 1111 of the balloon 111. At this time, after the volume of the aneurysm 200 is reduced, the presence of the space occupying efficiency of the aneurysm 200 can be avoided, and the potential safety hazard is reduced.

In the aneurysm treatment device 100 of the present invention, when the balloon 111 is supported by the expansion stent 121 and a contrast medium is injected into the balloon 111, the balloon 111 can be expanded to discharge blood in the tumor cavity 210 until the balloon 111 is expanded and approximately matches the shape of the tumor cavity 210. The contrast medium in the capsule body 111 is discharged, and the aneurysm 200 can be driven to synchronously shrink in the process of shrinking the capsule body 111, so that the volume of the aneurysm 200 is reduced, and the occupation effect of the aneurysm 200 is effectively reduced.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (19)

1. An aneurysm treatment device for implantation within an aneurysm, the aneurysm treatment device comprising:

a balloon comprising a hollow balloon body, the balloon body being expandable or contractible, the balloon body having an opening, the balloon body being capable of entering into the aneurysm, the balloon body being capable of allowing filling or draining of contrast agent inside; and

the expansion assembly is arranged on the bag body and used for supporting the bag body and opening or closing the opening, and the bag body can be sealed when the opening is closed by the expansion assembly;

When the capsule is filled with contrast agent, the capsule is inflated and the outer wall is capable of abutting at least a portion of the inner wall of the aneurysm; when the balloon is expelled from the contrast agent, the balloon contracts and the negative pressure acts to contract the aneurysm.

2. The aneurysm treatment device of claim 1 wherein the inflation assembly comprises an inflation stent that is capable of being contracted or inflated, the inflation stent being in contact with the balloon, the inflation stent being capable of either expanding the balloon or inflating the balloon with the contrast agent to expose an opening of the balloon, and a closure stent at least partially connected to the inflation stent and opening or closing the opening, the closure stent being capable of sealing the balloon when closing the opening.

3. The aneurysm treatment device of claim 2, wherein the inflation stent is disposed inside the balloon, the inflation stent abutting an inner surface of the balloon.

4. The aneurysm treatment device of claim 2, wherein the expansion stent is disposed on an exterior of the balloon, the expansion stent being in contact with an exterior surface of the balloon.

5. The aneurysm treatment device of claim 2 wherein the expansion stent comprises a first end and a second end, the first end and the second end being positioned at respective ends of the expansion stent, the first end having a radial dimension greater than a radial dimension of the second end such that the expansion stent assumes a flared configuration after expansion, the second end being in contact with an edge of the opening of the balloon.

6. The aneurysm treatment device of claim 2, wherein the expansion stent conforms to the balloon when the expansion stent is expanded.

7. The aneurysm treatment device of claim 6 wherein the expansion stent is only partially conformable to the balloon.

8. The aneurysm treatment device of claim 2 wherein the expansion stent is a mesh structure formed by a plurality of braided wires cross-woven;

alternatively, the expanded stent is cut from a metal tube having self-expansibility.

9. The aneurysm treatment device of claim 8, wherein each of the braided wires is shaped as a straight line, a curve, or a combination of straight and curve.

10. The aneurysm treatment device of claim 2, wherein the expansion stent is made of a resilient metallic material;

Alternatively, the expansion stent is made of non-elastic memory metal, and the contrast medium filled in the balloon expands the balloon.

11. The aneurysm treatment device of claim 10, wherein the expansion stent is made of at least one of nitinol, stainless steel, cobalt chrome alloy, nickel cobalt alloy, and a stretch filled tube.

12. The aneurysm treatment device of any one of claims 2-11 wherein a radial dimension of the closure stent is greater than a radial dimension of the opening.

13. The aneurysm treatment device of claim 12, wherein the opening is circular;

the closed support is round, or the closed support is provided with an inscribed circle;

the diameter of the closed bracket is 1.2-1.5 times of the diameter of the opening.

14. The aneurysm treatment device of any one of claims 2 to 12 wherein the closure stent is formed from a plurality of braided wires; alternatively, the closure bracket is formed by laser engraving.

15. The aneurysm treatment device of any one of claims 2-12, wherein the balloon further comprises a cover membrane covering the closure stent, the cover membrane sealing the opening when the closure stent closes the opening.

16. The aneurysm treatment device of any one of claims 1-12, wherein the balloon is a dense, watertight structure.

17. The aneurysm treatment device of any one of claims 1-12, wherein the balloon is made of a non-degradable polymeric material.

18. The aneurysm treatment device of claim 17, wherein the balloon is made of polytetrafluoroethylene, polyurethane, or polyethylene.

19. The aneurysm treatment device of any one of claims 1-12, further comprising a catheter for filling the interior of the balloon with a contrast agent;

the catheter remains extended from the opening until the balloon is inflated.