Film laminating device, its loading method, film laminating system and film laminating support system

Abstract

The present invention relates to a film coating device and its loading method, a film coating system and a film coating stent system. The advantages are that it can reduce the delivery size of the film coating stent and improve the flexibility of the film coating stent. The film coating stent system of the present invention includes a film coating system and a self-expanding stent, and the film coating system includes a film coating device and a balloon catheter. The film coating device includes a positioning stent and a film coating. The proximal end of the film coating is fixedly connected to the positioning stent, and the distal end of the film coating extends axially beyond the distal end of the positioning stent when the film coating device is in the deployed state. In practical applications, the film coating device is loaded by the balloon catheter and delivered into the aneurysm-bearing artery. Then, after the film coating device is positioned and released at the aneurysm position, it is supported by the self-expanding stent inside, so that the film coating is closely attached to the blood vessel wall to achieve the treatment of the aneurysm.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a coating device and a loading method thereof, a coating system and a coating stent system. Background Art

[0002] Coil embolization is a widely used endovascular interventional technique for the treatment of intracranial aneurysms. However, for giant intracranial aneurysms, wide-necked saccular aneurysms, blood blister aneurysms, microaneurysms, fusiform aneurysms, and dissecting aneurysms, coil embolization and stent-assisted coil embolization still have problems such as low postoperative complete occlusion rate, high long-term follow-up recurrence rate, and intraoperative aneurysm rupture and bleeding, making it difficult to achieve ideal treatment effects.

[0003] The reasons are that dense packing of giant intracranial aneurysms with coils is prone to space-occupying effect, and some aneurysms cannot be densely packed; wide-necked aneurysms are prone to residual coils at the neck of the aneurysm after packing; the aneurysm wall of blood bubble-like aneurysms is very thin, and there is no complete three-layer arterial vascular structure. During surgery, the microguidewire, microcatheter and coil touch the fragile aneurysm wall, which can easily lead to intraoperative bleeding, high disability and mortality rates; the coils in tiny aneurysms are difficult to stay in the aneurysm cavity, and some coils are prone to protruding into the tumor-bearing artery; the aneurysm cavity of fusiform aneurysms and dissecting aneurysms is irregular in shape, and there is no obvious boundary between the aneurysm cavity and the normal blood vessel cavity. Stent-assisted coils cannot effectively reshape the lumen in fusiform aneurysms.

[0004] The advent of covered stents provides a suitable solution for treating intracranial aneurysms. The therapeutic concept of covered stents has shifted from "intratumor packing" with coils to "intraluminal isolation." The treatment strategy involves inserting a covered stent into a blood vessel without the use of coils. This creates a biophysical barrier within the parent artery, remodeling the parent artery at the neck of the aneurysm and maintaining its patency. This isolates the intracranial aneurysm from the systemic circulation and allows for thrombosis to form within the aneurysm cavity, ultimately curing the lesion.

[0005] In the treatment of wide-necked, giant, blister-like, tiny, fusiform, and dissecting aneurysms without adjacent important branch vessels, the advantages of covered stents are more prominent. They can isolate the aneurysm cavity from the vascular cavity, immediately seal the aneurysm neck, and change the hemodynamics in the parent artery, achieving true vascular reconstruction. This not only avoids the risk of intraoperative rupture and bleeding of the aneurysm caused by the micro-guide wire, micro-catheter, and coil touching the fragile aneurysm wall during the operation, but also strengthens the repair of the parent artery, can avoid residual aneurysm neck, avoid and relieve the mass effect after coil embolization, and avoid recurrence, recanalization, and rupture and bleeding of the aneurysm after surgery. However, due to the restraint of the film, the entire covered stent is insufficiently deformed, especially the axial stretching during delivery is insufficient, which increases the size of the delivery system and makes the covered stent unable to reach the location of smaller intracranial lesions. Moreover, the restraint of the film also causes the flexibility of the entire stent to deteriorate, making it difficult to conform to the tortuous intracranial blood vessels, which all affect the application of the covered stent. Summary of the Invention

[0006] The purpose of the present invention is to provide a covered device, its loading method, a covered system, and a covered stent system to solve the problems of large delivery size and poor flexibility of the existing covered stents.

[0007] To achieve the above purpose, the present invention provides a covered device having an unfolded state and a folded state, which includes a positioning stent and a covering film; the proximal end of the covering film is fixedly connected to the positioning stent, and the distal end of the covering film axially extends beyond the distal end of the positioning stent when the covered device is in the unfolded state.

[0008] Optionally, when the covered device is in the folded state, the distal end of the covering film axially extends beyond the distal end of the positioning stent and is circumferentially folded.

[0009] Optionally, the distal end of the covering film is freely folded circumferentially or folded according to a predetermined rule.

[0010] Optionally, when the covered device is in the folded state, the outermost distal end of the covering film has a necked shape.

[0011] Optionally, when the covered device is in the folded state, at least a part of the covering film is axially folded and hidden inside the positioning stent.

[0012] Optionally, when the covered device is in the folded state, a part of the distal end of the covering film axially extends beyond the distal end of the positioning stent and is circumferentially folded, and another part of the distal end of the covering film is axially folded and hidden inside the positioning stent.

[0013] Optionally, the entire distal end of the covering film is axially folded and hidden inside the positioning stent.

[0014] Optionally, the positioning stent is a passively expandable stent.

[0015] Optionally, when the film covering device is in the deployed state, the axial length of the positioning stent is 3.0 mm to 9.0 mm.

[0016] Optionally, the positioning stent includes at least one support ring, and the support ring includes a wire or a pipe having a corrugated or toothed shape.

[0017] Optionally, when the film covering device is in the deployed state, the axial length of the film covering is 3.0 mm to 60 mm.

[0018] Optionally, the film covering is made by electrospinning, and the material of the film covering is selected from at least one of polytetrafluoroethylene, expanded polytetrafluoroethylene, and polyethylene terephthalate.

[0019] Optionally, the film covering is a single-layer film covering.

[0020] Optionally, the proximal end of the film covering covers at least a part of the inner surface and / or at least a part of the outer surface of the positioning stent.

[0021] Optionally, the positioning stent is sleeved on the film covering, and the proximal end of the film covering is turned outwards and covers the entire outer surface of the positioning stent.

[0022] Optionally, the proximal end of the film covering is cemented, sutured, or heat-melted to the positioning stent.

[0023] To achieve the above object, the present invention further provides a film covering system, including any one of the film covering devices; and a balloon catheter including an inflatable balloon located at the distal end;

[0024] Wherein: the film covering device is crimped on the inflatable balloon, and the film covering is folded on the inflatable balloon.

[0025] Optionally, the inflatable balloon has at least one first imaging structure for indicating the position of the positioning stent.

[0026] Optionally, the inflatable balloon has at least one second imaging structure for indicating the position of the most distal end of the film covering when the film covering device is deployed.

[0027] Optionally, the inflatable balloon includes a proximal conical section, an inflatable body, a distal conical section, and a guide head sequentially arranged from near to far;

[0028] Wherein, the guide head constitutes the second imaging structure, or the second imaging structure is arranged at the most distal end of the inflatable body.

[0029] Optionally, when the membrane covering device is pressed and held on the inflatable balloon, the distal end of the membrane covering extends axially beyond the distal end of the positioning bracket and is circumferentially folded on the inflatable balloon.

[0030] Optionally, the distal end of the membrane covering is circumferentially folded on the inflatable balloon in a folded state.

[0031] Optionally, the inflatable balloon is folded together with the distal end of the membrane covering and completely coincides circumferentially.

[0032] Optionally, the inflatable balloon includes a proximal conical section, an inflatable body, a distal conical section, and a guide head arranged in sequence from near to far;

[0033] Wherein, the outermost distal end of the membrane covering is folded on the distal conical section or the guide head, and the outermost distal end of the membrane covering is in a necked shape.

[0034] Optionally, when the membrane covering device is pressed and held on the inflatable balloon, at least a part of the membrane covering is axially folded and hidden inside the positioning bracket.

[0035] Optionally, when the membrane covering device is pressed and held on the inflatable balloon, a part of the distal end of the membrane covering extends axially beyond the distal end of the positioning bracket and is circumferentially folded on the inflatable balloon, and another part of the distal end of the membrane covering is axially folded and hidden inside the positioning bracket.

[0036] Optionally, the inflatable balloon includes a proximal conical section, an inflatable body, a distal conical section, and a guide head arranged in sequence from near to far;

[0037] Wherein: the part of the distal end of the membrane covering extends to the distal end of the inflatable body, and the length of the membrane covering is configured such that when the other part of the axially folded distal end of the membrane covering is unfolded, the outermost distal end of the membrane covering extends to the guide head.

[0038] Optionally, when the membrane covering device is pressed and held on the inflatable balloon, the entire distal end of the membrane covering is axially folded and hidden inside the positioning bracket.

[0039] To achieve the above object, the present invention further provides a membrane covered stent system, including:

[0040] Any one of the above-mentioned membrane covering systems; and

[0041] A self-expanding stent for internally supporting the membrane covering device so that the membrane covering of the membrane covering device fits on a predetermined object.

[0042] To achieve the above object, the present invention further provides a loading method for the above-mentioned membrane covering device, including:

[0043] A balloon catheter is provided, comprising an inflatable balloon at a distal end;

[0044] The coating device is pressed and gripped on the inflatable balloon, and the coating of the coating device is folded on the inflatable balloon.

[0045] Optionally, the step of folding the coating of the coating device onto the inflatable balloon includes: extending the distal end of the coating axially and exposing it to the distal end of the positioning stent, and folding the distal end of the coating circumferentially onto the inflatable balloon.

[0046] Optionally, folding the distal end of the coating circumferentially onto the inflatable balloon includes: first folding the inflatable balloon, and then folding the distal end of the coating circumferentially onto the inflatable balloon in a folded state; or, folding the distal end of the coating together with the inflatable balloon, so that the distal end of the coating completely overlaps with the inflatable balloon in the circumferential direction.

[0047] The film grafting device and loading method thereof, the film grafting system and the film grafting stent system provided by the present invention have the following advantages:

[0048] The above-mentioned coating system and the self-expanding stent together constitute a coated stent system. During actual use, the coating device is first delivered into the body through a balloon catheter and positioned and fixed near the aneurysm. Then, the self-expanding stent is delivered into the body and supported inside the coating device. This allows the coating of the coating device to closely adhere to the blood vessel wall, isolating the aneurysm cavity from the blood vessel cavity, thereby achieving the purpose of curing the lesion.

[0049] The above-mentioned coated device is delivered separately from the self-expanding stent and has an independent structure. The positioning stent in the coated device is shorter than the coating. This can reduce the constraint of the coating on the positioning bare stent and the entire coated stent system, thereby greatly improving the flexibility of the coated device, reducing the pushing force of the coated device, and increasing the ability to pass through tortuous blood vessels, which helps to reach more distal lesions in the brain and improve the cure rate of the disease.

[0050] The axial length of the positioning stent in the above-mentioned coating device is shorter than the coating, the constraint of the coating on the positioning stent is reduced, and the positioning stent has greater axial stretching freedom, which further makes the delivery size of the coating device smaller, so it can be delivered through a smaller catheter, which helps to reach the location of small intracranial vascular lesions and improve the cure rate of the disease.

[0051] During the loading process of the above-mentioned coating device, the coating is folded on the balloon, for example, folded circumferentially and / or axially on the balloon. This makes the compressed size of the coated stent smaller, or avoids the problem of the tail end of the coating rising up, which leads to increased pushing resistance or difficulty in sheathing, and is more conducive to delivery. Description of the Drawings

[0052] Figure 1 is a schematic structural view of a covered stent;

[0053] Figure 2 is a schematic structural view of the covered system provided in the first embodiment of the present invention, wherein the positioning stent is sleeved on the cover film, and the proximal end of the cover film is turned up and wraps part of the outer surface of the positioning stent;

[0054] Figure 3 is a schematic structural view of the covered system provided in the first embodiment of the present invention, wherein the positioning stent is arranged inside the cover film, and the proximal end of the cover film wraps the entire outer surface of the positioning stent;

[0055] Figure 4 is a schematic view when the covered device provided in the second embodiment of the present invention is folded together with the expandable balloon;

[0056] Figure 5 is a schematic structural view of the covered system provided in the third embodiment of the present invention;

[0057] Figure 6 is a schematic structural view of the covered system provided in the fourth embodiment of the present invention, wherein the expandable balloon is shorter;

[0058] Figure 7 is a schematic structural view of the covered system provided in the fourth embodiment of the present invention, wherein the expandable balloon is longer

[0059] Figure 8 is a schematic structural view of the covered system provided in the fifth embodiment of the present invention.

[0060] In the figure:

[0061] 1 - stent body, 2 - cover film;

[0062] 11 - positioning stent; 12 - cover film;

[0063] 111 - proximal end face; 112 - outer side face; 113 - distal end face;

[0064] 20 - expandable balloon; 201 - proximal tapered section; 202 - expandable body; 203 - distal tapered section; 204 - guide head;

[0065] 21 - proximal imaging structure; 22 - distal imaging structure; 23 - balloon folding wing.

[0066] In the drawings, the same or similar components are denoted by different reference numerals. Detailed Description of the Invention

[0067] To make the objectives, advantages, and features of the present invention more clear, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are in a very simplified form and are not drawn to an accurate scale, and are only used to facilitate and clearly assist in explaining the objectives of the embodiments of the present invention.

[0068] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in the sense of including "and / or" unless the context clearly dictates otherwise. The term "plural" is generally used in the sense of including two or more unless the context clearly dictates otherwise. In addition, for ease of description, the terms "distal" and "proximal" are used; "proximal" is the end closer to the operator of the medical device; "distal" is the end farther from the operator of the medical device; "proximal" and "distal" generally refer to two opposite parts, including but not limited to endpoints, unless the context clearly dictates otherwise.

[0069] As in the background art, currently, the delivery size of the covered stent is large and the flexibility is also poor. As Figure 1 shown, the covered stent generally includes a stent body 1 and a film 2 covering the stent body 1. The stent body 1 is a self-expanding tubular mesh structure formed by connecting a plurality of grid units, and the film 2 is fixedly covered on the middle part of the stent body 1. When the covered stent is compressed into the delivery system, since the deformation amounts of the film 2 and the stent body 1 are inconsistent (the deformation amount of the film is less than that of the stent body), the film 2 will restrict the deformation of the stent body 1, resulting in the entire stent not being effectively compressed and increasing the delivery size. In particular, most of the stent body 1 is wrapped by the film 2, resulting in poor flexibility of the entire stent and difficulty in conforming to the tortuous blood vessels in the brain, so that it is impossible to reach the distal blood vessels in the brain, all of which affect the application of the covered stent.

[0070] Therefore, the embodiments of the present invention provide a film covering device, a film covering system, and a covered stent system, which can not only increase the flexibility of the covered stent, reduce the pushing resistance of the covered stent, increase the ability to pass through tortuous blood vessels and the ability to conform to the curved shape, but also reduce the delivery size of the covered stent, which helps to be delivered through a delivery catheter with a smaller size, thereby improving the clinical applicability of the covered stent and the cure rate of diseases.

[0071] Specifically, the covered stent system proposed in the embodiments of the present invention includes a covering system and a self-expanding stent. The covering system includes a covering device and a balloon catheter. The covering device is, for example, a covered stent, which includes a positioning stent and a covering, and the axial length of the positioning stent is shorter than that of the covering. In practical applications, the proximal end of the covering is fixedly connected to the positioning stent, while the distal end of the covering needs to axially extend beyond the distal end of the positioning stent when the covering device is in the deployed state, so that the distal end of the covering fits against the blood vessel wall and the aneurysm neck, and the self-expanding stent is used to support inside the covered stent to make the covering fit against the aneurysm neck (i.e., the predetermined object), and firmly position and fix the covered stent at the position of the aneurysm, so as to isolate the aneurysm cavity from the blood vessel cavity and achieve the purpose of aneurysm treatment.

[0072] More specifically, the covering device proposed in the embodiments of the present invention needs to be loaded on the balloon catheter and is transported and expanded (or deployed) by the balloon catheter. The balloon catheter of the embodiments of the present invention includes an inflatable balloon at the distal end. Before being implanted into the body, the covering device is crimped on the inflatable balloon, and at the same time, the covering of the covering device is folded on the inflatable balloon, thereby reducing the delivery size of the covering device and realizing the deployment and release of the covering device through the inflatable balloon. Here, the crimping can also be called folding. For example, the covering device can be crimped on the inflatable balloon by a crimper to make the covering device relatively fixed on the inflatable balloon. During the transportation process, the covering device is in a folded state. Since the axial length of the covering is longer than that of the positioning stent (i.e., the axial length of the positioning stent is shorter than that of the covering), the entire covering device can be better compressed to reduce the delivery size, and at the same time, the covering has better flexibility, which is convenient for adapting to the shape of the blood vessel and smoothly pushing. In particular, the inflatable balloon can also play a role in shaping the aneurysm neck, thereby reducing the formation of thrombus.

[0073] In the embodiments of the present invention, since the positioning stent is deployed and released by means of an inflatable balloon, the positioning stent is mainly a passively expandable stent. In addition, the positioning stent specifically includes at least one support ring, and more preferably one or two support rings. In this case, the positioning stent has better flexibility. The support ring in this embodiment specifically includes a pipe or wire with a corrugated or toothed shape, and the positioning stent is preferably formed by laser cutting of an alloy pipe. The material of the alloy pipe is more preferably stainless steel or cobalt-chromium alloy, which can reduce the material and processing costs. The positioning stent in this embodiment is specifically a bare stent, which is only composed of support rings. In other embodiments, the positioning stent may also include coatings, drugs, etc. loaded on the support rings. In some other embodiments, the positioning stent may also be a self-expandable stent. In this embodiment, when the membrane covering device is in the deployed state, the axial length of the positioning stent is 3.0 mm to 9.0 mm. However, the present invention does not make a special limitation on the axial length of the positioning stent, as long as the flexibility and effective positioning and fixing of the membrane covering device can be ensured. In addition, when the membrane covering device is in the deployed state, that is, when it is completely released in the body, the distal end of the membrane covering extends axially beyond the distal end of the positioning stent. The axial length of the membrane covering is preferably 3.0 mm to 60 mm. Such a range can ensure that the length of the membrane covering can cover both the blood blister-like aneurysm with a small aneurysmal neck and meet the requirements for covering the aneurysmal necks of giant intracranial aneurysms and wide-neck aneurysms.

[0074] The membrane covering may be a single-layer membrane covering or a double-layer membrane covering, and more preferably a single-layer membrane covering, which will not increase the delivery size. During preparation, the proximal end of the membrane covering wraps at least part of the inner surface and / or at least part of the outer surface of the positioning stent. Preferably, the membrane covering wraps the entire outer surface of the positioning stent, so as to avoid the exposure of the stent and damage to blood vessels or tissues. In some embodiments, the positioning stent is sleeved on the membrane covering, and the membrane covering is turned outwards from the inside of the positioning stent at the proximal end of the positioning stent and wraps part or all of the outer surface of the positioning stent. In some embodiments, the entire membrane covering is disposed outside the positioning stent, and the membrane covering wraps the entire outer surface of the positioning stent from the proximal end of the positioning stent. Specifically, the positioning stent has a proximal end face, a distal end face, and an outer side face located between the proximal end face and the distal end face. It should be understood that the "end face" refers to the metal part of the end face of the positioning stent, excluding the hollow part of the end face of the positioning stent. Preferably, the membrane covering wraps the proximal end face and the outer side face, and more preferably also wraps the distal end face. That is, the membrane covering does not wrap the entire end face of the positioning stent, otherwise blood flow cannot pass through. Instead, it wraps the edge of the end face (i.e., the metal part of the stent), that is, it crosses the edge and wraps both the inner side face and the outer side face of the positioning stent at the same time.

[0075] The film coating is preferably made by electrospinning, and the material of the film coating is preferably a biocompatible polymer material, such as at least one polymer material selected from polytetrafluoroethylene, expanded polytetrafluoroethylene, and polyethylene terephthalate, which can promote cell growth and is beneficial to promoting endothelialization of cells. In addition, the proximal end of the film coating is fixedly connected to the positioning stent in a manner including but not limited to glue bonding, heat fusion connection, or suturing.

[0076] The following further describes the film coating device, film coating system, and film coating stent system proposed in the embodiments of the present invention in conjunction with the accompanying drawings and several embodiments.

[0077] Embodiment 1

[0078] Figure 2 It is a schematic structural diagram of the film coating system provided in Embodiment 1 of the present invention, in which the film coating device is in an axially split state.

[0079] As Figure 2 shown, the film coating system of this embodiment includes a film coating device and a balloon catheter. The film coating device includes a positioning stent 11 and a film coating 12, and the length of the film coating 12 along the axis of the film coating device is longer than that of the positioning stent 11. Before loading onto the balloon catheter, the film coating device is prepared first. For example, the positioning stent 11 is sleeved on the film coating 12, and then the proximal end of the film coating 12 is turned outwards to cover the proximal end face 111 and the outer side face 112 of the positioning stent 11 (see Figure 3 ), and more preferably, it further covers the distal end face 113 of the positioning stent 11, and the proximal end of the film coating 12 is fixedly connected to the positioning stent 11, such as by suturing, heat fusion, or gluing, while ensuring that the distal end of the film coating 12 extends axially beyond the distal end of the positioning stent 11. However, the length by which the film coating 12 extends axially beyond the distal end of the positioning stent 11 is not particularly limited, and the basic requirement is to be able to completely cover the aneurysm neck opening. After the film coating device is prepared, it is then loaded onto the inflatable balloon 20 at the distal end of the balloon catheter. During the loading process, the entire film coating device can be compressed (or folded) onto the inflatable balloon 20 by a compression gripper to ensure that the film coating device does not slip off the inflatable balloon 20.

[0080] In this embodiment, a method for loading a film coating device is provided. Please continue to refer to Figure 2 :

[0081] First, the inflatable balloon 20 is folded, but the number of folding wings is not limited and can be three wings, five wings, or more folding wings;

[0082] After that, the film covering device is pressed onto the folded inflatable balloon 20. When pressing the film covering device, the distal end of the film 12 (i.e., the part defined by dimension L) extends axially and is exposed at the distal end of the positioning bracket 11, and the distal end of the film 12 is circumferentially freely folded onto the inflatable balloon 20. The so-called "free folding" means that there is no limitation on the folding shape, and the film can be folded circumferentially at will and attached to the balloon surface.

[0083] In this loading method, the distal end of the film and the balloon folding wing do not completely coincide circumferentially, and there is a certain gap. Thus, the distal end of the film is freely folded and closely attached to the balloon, with small pushing resistance and good flexibility of the film covering device. After the balloon is filled and inflated, the entire film covering device can closely adhere to the wall of the parent artery of the aneurysm, and with the support of a self-expanding stent (not shown in the figure), the aneurysm can be immediately isolated from the systemic circulation, and the length of the distal end of the film can ensure that it can cover both the blister-like aneurysm with a small aneurysm neck opening and the large internal carotid artery aneurysm and the aneurysm neck opening of the wide-neck aneurysm.

[0084] This embodiment also provides a method for using a film covering device, which includes the following steps:

[0085] Step 1: Introduction and positioning of the film covering device: First, through a guiding catheter in cooperation with a micro-guide wire, the balloon catheter loaded with the film covering device is introduced into the parent artery distal to the aneurysm neck opening, so that the most distal end of the film 12 completely crosses the aneurysm neck opening, and the positioning bracket 11 is positioned proximal to the aneurysm neck opening;

[0086] Step 2: Release of the film covering device: Slightly withdraw the guiding catheter to expose the distal end of the balloon catheter, and then slowly fill the inflatable balloon 20 until the positioning bracket 11 is completely expanded and released, and then deflate the inflatable balloon 20 and withdraw the balloon catheter from the human body; in this step, during the process of filling the balloon, it can be named to press and fill the balloon and maintain for about 10S to ensure that the positioning bracket 11 is completely expanded and released, so as to be anchored by the positioning bracket 11 at the proximal end of the aneurysm neck opening and fix the film covering device in the position of the aneurysm;

[0087] Step 3: Introduction and positioning of the self-expanding stent: After the delivery catheter for delivering the self-expanding stent is sent into the body along the guiding catheter and the micro-guide wire in Step 1 and passes through the film covering device, the distal end of the delivery catheter is placed at the distal end of the film covering device, that is, the distal end of the film, and then the micro-guide wire is withdrawn; after withdrawing the micro-guide wire, the self-expanding stent is pushed through the delivery catheter by the push rod and positioned at the distal end of the delivery catheter, that is, the distal end of the film;

[0088] Step 4: Self-expanding stent release: Fix the pusher rod for pushing the self-expanding stent to keep the self-expanding stent stationary and retract the delivery catheter to release most of the self-expanding stent, so that the effective length of the self-expanding stent can fully support the distal part of the fixed membrane (that is, at least part of the membrane that does not cover the positioning stent is supported by the self-expanding stent);

[0089] Step 5: Recheck the angiography to evaluate the occlusion effect. If there is endoleak at the proximal end of the aneurysm or the membrane does not adhere well to the wall, the self-expanding stent can be retrieved and adjusted slightly and then released again until the angiography shows that the occlusion of the aneurysm neck reaches the requirements, and then the self-expanding stent is fully released;

[0090] Step 6: Withdraw the delivery catheter, pusher rod and guiding catheter to complete cerebral angiography.

[0091] In the above Step 1, at least one proximal imaging structure 21 (i.e., the first imaging structure) on the inflatable balloon 20 can be used to observe the position of the positioning stent 11 during the implantation process. That is, the position of the proximal imaging structure 21 corresponds to the position of the positioning stent 11. Therefore, by means of the imaging of the proximal imaging structure 21 during the operation, the position of the positioning stent 11 can be determined, so that the positioning stent 11 is accurately positioned at the proximal end of the aneurysm neck. In addition, at least one distal imaging structure 22 (i.e., the second imaging structure) is also provided on the inflatable balloon 20. The position of the distal imaging structure 22 corresponds to the position of the most distal end of the membrane. Therefore, by means of the imaging of the distal imaging structure 22 during the operation, the position of the most distal end of the membrane when the membrane device is deployed can be determined, ensuring that the entire aneurysm neck can be covered after the membrane is deployed. The imaging structure of this embodiment is specifically made of a material that is impervious to X-rays, and the specific material is not limited. It should be known that in Figure 2 the shown loading method, the distal imaging structure 22 indicates the position of the most distal end of the membrane during the delivery process and release of the membrane device.

[0092] The inflatable balloon 20 specifically includes a proximal tapered section 201, an inflatable body 202, a distal tapered section 203 and a guiding head 204 arranged in sequence from near to far. Optionally, the guiding head 204 has imaging properties, and the proximal imaging structure 21 and the distal imaging structure 22 are both arranged on the inflatable body 202. Among them, the proximal imaging structure 21 can be arranged at the nearest end of the inflatable body, and the distal imaging structure 22 is arranged at the most distal end of the inflatable body, and the membrane device is also crimped on the inflatable body 202. And in this embodiment, the positioning stent 11 is arranged on the outer side surface of the membrane 12 at the proximal end of the inflatable body 202, and the distal end of the membrane 12 extends axially to the distal end of the inflatable body 202. Optionally, the axial length of the entire membrane device is equal to the axial length of the inflatable body 202. That is, the proximal end surface of the positioning stent 11 is aligned with the proximal end surface of the inflatable body 202, and the most distal end of the membrane 12 is aligned with the distal end surface of the inflatable body 202.

[0093] The positioning bracket 11 includes at least one support ring, but the structure of the support ring is not shown in detail. After those skilled in the art learn that the support ring includes a pipe or wire with a corrugated or toothed shape, they should be able to know how to form the support ring.

[0094] The present invention does not specifically limit the specific manner of covering the positioning bracket with the film. It can be either Figure 2 covered inside and outside in the manner shown. In other embodiments of the present invention, it can also be Figure 3 covered only on the outside in the manner shown. By covering, the firmness of the connection can be provided and the operability of the process can be increased. Specifically, in the Figure 3 manner shown, the positioning bracket 11 is arranged inside the proximal end of the film 12, and the proximal end of the film completely wraps the positioning bracket 11, while the distal end of the film still axially extends to the distal end of the expandable body 202. However, its loading method and usage method are Figure 2 basically the same.

[0095] Embodiment 2

[0096] The film system provided in this embodiment is basically the same as that in Embodiment 1. Only the differences will be described below.

[0097] Figure 4 FIG. is a schematic diagram when the film device provided in Embodiment 2 of the present invention is folded together with the expandable balloon. However, only the state during folding is shown in the figure, and the state after folding is not shown. Different from Embodiment 1, in this embodiment, the expandable balloon 20 and the film device are simultaneously compressed and held, and the distal end of the film coincides completely with the expandable balloon 20 in the circumferential direction, that is, the distal end of the film coincides completely with the balloon folding wing 23 in the circumferential direction without gaps. In this loading method, by the close fit of the distal end of the film and the balloon folding wing, the compressed size of the film device can be further reduced, the pushing resistance can be reduced, and it is more effective to prevent the offloading caused by the relative displacement between the positioning bracket and the balloon. However, the number of the balloon folding wings 23 is not limited, including but not limited to the five balloon folding wings shown in the figure. Therefore, in this embodiment, the distal end of the film is not folded randomly in the circumferential direction, but is folded according to a predetermined rule, so that the film fits more closely with the balloon and the compressed size is smaller.

[0098] Embodiment 3

[0099] The coating system provided in this embodiment is substantially the same as that in the first embodiment, and only the differences are described below. This embodiment is a further improvement on the second embodiment, specifically, the coating is lengthened so that its distal end can extend axially beyond the distal end of the expandable body 202, for example, extending to the distal conical section 203 of the balloon or the guide head 204 of the expandable balloon. This enables the distal end of the coating to have a constricted shape, i.e., the size (diameter or circumference) of the distal end of the coating is smaller than the size of the proximal end of the coating, further reducing the risk of the tail end (i.e., the distal end) of the coating tilting, resulting in increased push resistance or difficulty in sheathing.

[0100] Specific reference Figure 5 , which is a schematic structural diagram of the coating system provided in the third embodiment of the present invention. In this embodiment, the coating 12 is lengthened so that the coating 12 can further closely fit the distal tapered section 203 and the guide head 204, forming a constricted tapered opening at the distal end of the coating. In this case, the distal imaging structure 22 can be eliminated, and the position of the distal end of the coating can be monitored by the guide head 204 (i.e., the guide head 204 constitutes the second imaging structure). However, in other embodiments, the guide head 204 and the distal imaging structure 22 can be retained simultaneously. For example, when the length of the coating that fits the expandable body 202 is sufficient to cover the tumor neck opening, the distal imaging structure 22 can be used to determine the position of the coating covering the tumor neck opening.

[0101] Example 4

[0102] The coating system provided in this embodiment is basically the same as that in the above embodiment, and only the differences are described below.

[0103] Figure 6 This is a schematic diagram of the structure of the coating system provided in the fourth embodiment of the present invention. Figure 6 As shown, similar to the first embodiment, in this embodiment, the inflatable balloon 20 is still folded first, and then the coating device is pressed onto the inflatable balloon 20 in the folded state (i.e. after folding and pressing), but when the coating device is pressed, the distal end of the coating 12 is completely axially folded (the axial length is shortened) and hidden in the positioning bracket 11. Here, the portion of the coating 12 hidden in the positioning bracket 11 does not extend axially beyond the two ends of the positioning bracket 11, and the coating 12 is folded axially for several layers, and the axial length of the positioning bracket 11 is equivalent to, or longer than, the axial length of the positioning bracket 11. After axial folding, the axial length of the coating can be selected to be 3.0mm to 10mm, and the number of layers after folding is 2 to 5 layers, but the folding method is not limited. In this loading method, a shorter balloon can be selected depending on the size of the tumor neck, such as Figure 6 As shown, a longer balloon can also be selected, such as Figure 7 shown.

[0104] In this embodiment, after the distal end of the membrane is inflated and expanded by the balloon and withdrawn from the human body, it unfolds under the impact of blood flow, and there will be no problem that the tail end of the membrane warps up, resulting in an increase in pushing resistance or difficulty in inserting into the sheath, and the delivery is relatively convenient. However, the length of the distal end of the membrane after unfolding in this embodiment is not limited. It can either extend to the distal end of the inflatable main body 202, or extend to the distal conical section 203 or the guiding head 204, specifically depending on the size of the aneurysm neck opening and the length of the inflatable balloon 20. Compared with the above embodiment, the delivery of the membrane device in this embodiment is more convenient, improving the ability of the membrane device to pass through tortuous blood vessels, and also enabling the length of the membrane after unfolding to cover the entire aneurysm neck opening.

[0105] Embodiment Five

[0106] The membrane system provided in this embodiment is basically the same as that in Embodiment Four, and only the differences will be described below.

[0107] Figure 8 It is a schematic structural diagram of the membrane system provided in Embodiment Five of the present invention. As Figure 8 shown, when the membrane device is pressed and held on the inflatable balloon 20, a part of the distal end of the membrane 12 is axially folded and hidden inside the positioning bracket 11, and another part of the distal end of the membrane 12 extends axially beyond the distal end of the positioning bracket 11 and is circumferentially folded on the balloon. In this loading method, either the balloon can be folded first, or the balloon and the membrane device can be folded together, and the length of the axially folded part of the membrane after unfolding is configured to be able to cause the outermost distal end of the membrane to extend to the guiding head 204, that is, when a part of the distal end of the axially folded membrane unfolds, the outermost distal end of the membrane extends to the guiding head 204.

[0108] The above embodiment has described in detail how to load the membrane device onto the inflatable balloon. Of course, the present invention includes but is not limited to the loading methods listed in the above embodiments, and the present invention also does not limit the way of fixedly connecting the proximal end of the membrane to the positioning bracket. Any content obtained by changing on the basis of the loading methods and connection methods provided in the above embodiments belongs to the scope protected by the present invention. Those skilled in the art can draw inferences from one instance to another based on the content of the above embodiments.

[0109] The membrane stent system provided by the embodiments of the present invention includes but is not limited to the treatment of intracranial aneurysms. Moreover, it should be known that when the membrane device is in a folded state, the outermost distal end of the membrane can axially extend to the distal conical section or the guiding head of the inflatable balloon, that is, the outermost distal end of the membrane can be folded on the distal conical section or the guiding head.

[0110] The above description is only a description of the preferred embodiments of the present invention and does not limit the scope of the present invention in any way. Any changes and modifications made by those of ordinary skill in the art of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

Claims

1. A film laminating device, having an unfolded state and a folded state, characterized in that, Comprising a positioning stent and a membrane; the positioning stent is a passive expansion stent deployed and released by an inflatable balloon; the proximal end of the membrane is fixedly connected to the positioning stent, and the distal end of the membrane axially extends beyond the distal end of the positioning stent when the membrane device is in the deployed state; when the membrane device is in the folded state, the distal end of the membrane axially extends beyond the distal end of the positioning stent and is circumferentially folded, or a part of the distal end of the membrane axially extends beyond the distal end of the positioning stent and is circumferentially folded, and another part of the distal end of the membrane is axially folded and hidden inside the positioning stent, or the distal end of the membrane is entirely axially folded and hidden inside the positioning stent.

2. The film laminating device according to claim 1, wherein When the membrane device is in the folded state, the distal end of the membrane is freely folded circumferentially or folded according to a predetermined rule.

3. The film laminating device according to claim 1, wherein, When the membrane device is in the folded state, the outermost distal end of the membrane is in a constricted shape.

4. The film laminating device according to claim 1, characterized in that, When the membrane device is in the deployed state, the axial length of the positioning stent is 3.0 mm to 9.0 mm.

5. The film laminating device according to claim 1, wherein, The positioning stent includes at least one support ring, and the support ring includes a wire or a pipe having a corrugated or toothed shape.

6. The film laminating device according to claim 1, wherein When the membrane device is in the deployed state, the axial length of the membrane is 3.0 mm to 60 mm.

7. The film laminating device according to claim 1, characterized in that, The membrane is made by electrospinning, and the material of the membrane is selected from at least one of polytetrafluoroethylene, expanded polytetrafluoroethylene, and polyethylene terephthalate.

8. The film laminating device according to claim 1, characterized in that, The membrane is a single-layer membrane.

9. The film laminating device according to claim 1, characterized in that The proximal end of the membrane covers at least part of the inner surface and / or at least part of the outer surface of the positioning stent.

10. The film laminating device according to claim 1, characterized in that The positioning stent is sleeved on the membrane, and the proximal end of the membrane is turned outwards to cover the entire outer surface of the positioning stent.

11. The film laminating device according to claim 1, characterized in that, The proximal end of the membrane is cemented, sutured, or heat-melted to the positioning stent.

12. A film laminating system, characterized in that, Comprising a membrane device according to any one of claims 1-11; and a balloon catheter, including an inflatable balloon located at the distal end; Wherein: the membrane device is crimped on the inflatable balloon, and the membrane is folded on the inflatable balloon; when the membrane device is crimped on the inflatable balloon, the distal end of the membrane axially extends beyond the distal end of the positioning stent and is circumferentially folded on the inflatable balloon, or a part of the distal end of the membrane axially extends beyond the distal end of the positioning stent and is circumferentially folded on the inflatable balloon, and another part of the distal end of the membrane is axially folded and hidden inside the positioning stent, or the distal end of the membrane is entirely axially folded and hidden inside the positioning stent.

13. The film coating system according to claim 12, wherein, The inflatable balloon has at least one first imaging structure for indicating the position of the positioning stent.

14. The film laminating system according to claim 12, wherein The inflatable balloon has at least one second imaging structure for indicating the position of the outermost distal end of the membrane when the membrane device is deployed.

15. The film laminating system according to claim 14, wherein, The inflatable balloon includes a proximal tapered section, an inflatable body, a distal tapered section, and a guide head arranged in sequence from near to far; Wherein, the guide head constitutes the second imaging structure, or the second imaging structure is arranged at the outermost distal end of the inflatable body.

16. The film laminating system according to claim 12, wherein, The distal end of the membrane is circumferentially folded around the inflatable balloon in the folded state.

17. The film coating system according to claim 12, characterized in that, The inflatable balloon and the distal end of the membrane are folded together and completely coincide circumferentially.

18. The film laminating system according to claim 12, characterized in that, The inflatable balloon includes a proximal tapered section, an inflatable body, a distal tapered section, and a guide head arranged in sequence from proximal to distal; Wherein, the outermost distal end of the membrane is folded on the distal tapered section or the guide head, and the outermost distal end of the membrane is in a necked shape.

19. The film laminating system according to claim 12, wherein The inflatable balloon includes a proximal tapered section, an inflatable body, a distal tapered section, and a guide head arranged in sequence from proximal to distal; Wherein: a part of the distal end of the membrane extends to the distal end of the inflatable body, and the length of the membrane is configured such that when another part of the axially folded distal end of the membrane unfolds, the outermost distal end of the membrane extends to the guide head.

20. A covered stent system, characterized in that, Comprising: A membrane system according to any one of claims 12-19; And A self-expanding stent for internally supporting the membrane device to make the membrane of the membrane device fit a predetermined object.

21. A loading method for a film laminating device as described in any one of claims 1-11, characterized in that, Comprising: Providing a balloon catheter, the balloon catheter including an inflatable balloon at the distal end; Pressing and holding the membrane device on the inflatable balloon and folding the membrane of the membrane device on the inflatable balloon, including: axially extending and exposing the distal end of the membrane at the distal end of the positioning stent, and circumferentially folding the distal end of the membrane on the inflatable balloon.

22. The loading method of the film laminating device according to claim 21, characterized in that, Circumferentially folding the distal end of the membrane on the inflatable balloon includes: first folding the inflatable balloon, and then circumferentially folding the distal end of the membrane on the folded inflatable balloon, or folding the distal end of the membrane together with the inflatable balloon so that the distal end of the membrane and the inflatable balloon completely coincide circumferentially.

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