One-stop nerve interventional therapy photo-crosslinking stabilizing device

Abstract

The invention provides a one-stop nerve interventional therapy photo-crosslinking stabilizing device which comprises a balloon, the near end of the balloon is communicated with a first catheter, the side wall of the balloon is provided with an uncured first coating, and when the illumination condition or the ray condition of the environment where the first coating is located reaches a preset range, the first coating is cured; an isolating layer is arranged between the first coating and the balloon and is used for separating the first coating from the balloon. The first coating capable of being solidified is arranged on the surface of the balloon, plaques on the inner wall of a blood vessel can be fixed through the first coating capable of being solidified, and therefore the problems that the plaques are loosened and fall off due to balloon dilatation are avoided, and it is ensured that infarction or blood vessel stenosis and other problems cannot occur at the far end of a focus after dilatation; the first coating is difficult to adhere to the surface of the balloon, so that the first coating can be separated from the balloon after being cured.

Description

Technical Field

[0001] The present invention belongs to the technical field of interventional medical devices, and in particular relates to a one-stop neurointerventional treatment photocrosslinking stabilization device. Background Art

[0002] Atherosclerosis refers to the deposition of blood components such as lipids, proliferation of smooth muscle cells and increase of collagen fibers in the arterial intima, the formation of atherosclerotic lipid-containing necrotic lesions and vascular wall sclerosis. The basic pathological change is the formation of plaques on the surface of the arterial intima. If the lesion continues to worsen, secondary lesions such as calcification, atherosclerotic ulcer formation, thrombosis and intraplaque hemorrhage may occur. In particular, the latter two secondary lesions are prone to cause adverse consequences.

[0003] Atherosclerotic lesions are prone to affect large elastic arteries, such as coronary arteries, cerebral arteries, renal arteries and large branches of limb arteries, especially narrowing of the lumen of muscular arteries, and may even cause ischemic changes in tissues or organs. Myocardial infarction caused by coronary atherosclerosis and cerebral infarction caused by cerebral atherosclerosis are the most harmful to humans and are the cardiovascular diseases with the highest mortality rate.

[0004] Balloon angioplasty is widely used in the clinic to treat cardiovascular and cerebrovascular stenosis. Some drug-eluting balloons with drug coatings on the surface have a more obvious effect in controlling restenosis of blood vessels after dilation. However, when used to treat vascular stenosis caused by atherosclerosis, balloon angioplasty also has risks. For example, during the dilation process, the pressure of the balloon may cause plaques on the blood vessel wall to fall off and form embolism at the distal end of the treatment site with blood flow, causing ischemic symptoms again.

[0005] Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art. Summary of the invention

[0006] The purpose of the present invention is to provide a one-stop neurointerventional treatment photocross-linking stabilization device that can be used for dilation treatment of vascular stenosis. During treatment, it can effectively fix the plaques on the vascular wall to prevent the plaques attached to the vascular wall from falling off during vascular dilation, thereby solving the problem of the risk of plaque falling off when the existing balloon dilation catheter is used to treat vascular stenosis symptoms caused by atherosclerosis.

[0007] In order to achieve the above object, the present invention provides the following technical solutions:

[0008] A one-stop neurointerventional treatment light cross-linking stabilization device comprises a balloon, the proximal end of the balloon is connected to a first catheter, the side wall of the balloon is provided with an uncured first coating, and when the light condition or radiation condition of the environment in which the first coating is located reaches a preset range, curing occurs;

[0009] An isolation layer is provided between the first coating layer and the balloon, and the isolation layer is used to separate the first coating layer from the balloon.

[0010] Preferably, the lighting condition is a condition under visible light or ultraviolet light.

[0011] Preferably, the radiation conditions are conditions under X-ray irradiation.

[0012] Preferably, the isolation layer is fixed to the side wall surface of the balloon and is peeled off from the first coating after the first coating is cured.

[0013] Preferably, the isolation layer is closely attached to the side wall surface of the balloon, and is separated from the side wall of the balloon after the first coating is cured.

[0014] Preferably, the preset range is a wavelength of 10 to 500 nm.

[0015] Preferably, the preset range is 0.01 to 10 nm.

[0016] Preferably, the isolation layer is a release agent coating pre-fixed on the surface of the balloon, and the release agent is a silicone oil type release agent.

[0017] Preferably, the isolation layer is made of an elastic polymer material, and the polymer material can undergo elastic deformation or plastic deformation.

[0018] Preferably, the polymer material includes at least one of polyethylene, polyurethane, silica gel and polyamide.

[0019] Beneficial effects:

[0020] (1) The present invention solidifies the plaque on the inner wall of the blood vessel through the first coating on the surface of the balloon, thereby preventing the plaque from falling off due to expansion. After the expansion is completed, the first coating is solidified by light or X-ray irradiation, and an elastic polymer layer can be formed on the inner wall of the blood vessel to cover the plaque on the inner wall of the blood vessel, or the plaque is firmly adhered to the surface of the inner wall of the blood vessel, thereby effectively preventing the plaque from falling off;

[0021] (2) An isolation layer is provided between the first coating and the balloon surface. When the first coating is cured, the isolation layer serves to separate the first coating from the outer wall of the balloon to prevent the cured first coating from adhering to the balloon surface and causing the balloon to be unable to be retracted. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. Among them:

[0023] Figure 1This is a front view of a one-stop neurointerventional treatment photocrosslinking stabilization device provided in Example 1 of the present invention.

[0024] Figure 2 This is a schematic diagram of loading the balloon into the delivery catheter in Example 1 of the present invention.

[0025] Figure 3 This is a schematic diagram of providing an isolation layer on the surface of the balloon in Example 1 of the present invention.

[0026] Figure 4 This is a schematic diagram of providing an isolation layer on the surface of the balloon in Example 3 of the present invention.

[0027] Figure 5 This is a schematic diagram of the balloon dilating a blood vessel in Example 1 of the present invention.

[0028] Figure 6 This is a schematic diagram of the balloon after dilation is completed in Example 1 of the present invention.

[0029] Figure 7 This is a schematic diagram of curing the first coating layer in Example 1 of the present invention.

[0030] Figure 8 This is a schematic diagram of the first coating after curing in Example 1 of the present invention.

[0031] Fig. 9 This is a schematic diagram of curing the first coating in Example 2 of the present invention.

[0032] In the figure: 100, balloon; 200, first catheter; 300, delivery catheter; 101, first coating; 102, isolation layer; 201, optical fiber bundle. DETAILED DESCRIPTION

[0033] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention belong to the scope of protection of the present invention.

[0034] In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., and orientations or positional relationships indicated are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0035] In the description of the present invention, "several" means one or more, "more" means more than two, "greater than", "less than", "exceed" etc. are understood as not including the number itself, and "above", "below", "within" etc. are understood as including the number itself. If there is a description of "first" or "second", it is only used for the purpose of distinguishing the technical features, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0036] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more features.

[0037] In the description of the present invention, it should be noted that, unless otherwise clearly stipulated and limited, the term "connection" should be understood in a broad sense. For example, it can be a fixed connection or a movable connection, a detachable connection or a non-detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or mutual communication; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be internal connection between two elements, indirect connection, or an interactive relationship between two elements.

[0038] In the description of the present invention, “proximal end” refers to an end close to an operator, and “distal end” refers to an end far from an operator.

[0039] The present invention will be described in detail below in conjunction with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

[0040] In view of the problem that current balloon dilatation catheters have the risk of plaque detachment when treating vascular stenosis symptoms caused by atherosclerosis, the present invention provides a one-stop neurointerventional treatment photocross-linking stabilization device that can fix plaques on the inner wall of the blood vessel while dilating the stenotic part of the blood vessel, thereby preventing the plaques from loosening and falling off after dilation.

[0041] Specifically, the present invention provides a one-stop neurointerventional treatment optical cross-linking stabilization device, including a balloon 100, such as Figures 1-2 As shown, the proximal end of the balloon 100 is connected to the first catheter 200. The proximal end of the first catheter 200 is provided with an interface, through which liquid or gas medium can be filled into the balloon 100, and the medium is used to expand the balloon 100 and expand the inner wall of the narrowed blood vessel.

[0042] The side wall of the balloon 100 is provided with an uncured first coating 101. After the balloon 100 reaches the lesion site and expands to adhere to the wall, the first coating 101 can cover the lesion area, and then the first coating 101 is irradiated with light or radiation to solidify it, thereby fixing the plaque on the inner wall of the blood vessel at the lesion site, preventing the loosened plaque from falling off the blood vessel wall during the expansion process, thereby solving the problem of plaque falling off caused by balloon 100 dilatation when treating vascular stenosis symptoms caused by atherosclerosis, and preventing the plaque from forming an infarct at the distal end of the lesion to block blood circulation.

[0043] In the present invention, the composition of the first coating 101 is selected from adhesives that can be cured under specific lighting conditions or radiation conditions, such as existing photocurable adhesives, or medical UV glue or adhesives that are cured by visible light and meet medical standards, and adhesives that are cured by radiation exposure. Regardless of the type of adhesive selected, it should be ensured that the first coating 101 does not cure before reaching the lesion site.

[0044] In the present invention, in order to achieve the curing of the first coating 101, when the first coating 101 uses visible light or UV curing adhesive, the optical fiber bundle 201 can be delivered to the inside of the balloon 100 through the first catheter 200, and then the optical fiber bundle 201 is used to conduct visible light or UV light to irradiate from the inside of the balloon 100, such as Figure 7 As shown, the light passes through the wall of the balloon 100 and irradiates the first coating 101, thereby initiating a curing reaction. When this solution is adopted, the balloon 100 should be made of a material with high transparency to facilitate the passage of light.

[0045] When the first coating 101 is a radiation-cured adhesive, Figure 8 As shown, by using the penetrating property of X-rays, the irradiation can be performed by aligning the ray emission direction at the lesion site outside the body, which is more convenient than the solution of delivering optical fiber by optical fiber bundle 201.

[0046] After the first coating 101 is cured, it should be able to be separated from the balloon 100 relatively easily, otherwise it will affect the withdrawal of the balloon 100. To achieve this effect, an isolation layer 102 is provided between the first coating 101 and the balloon 100 to enable the first coating 101 to be separated from the balloon 100 after curing.

[0047] In a preferred embodiment of the present invention, the illumination condition is the condition under visible light or ultraviolet light (wavelength of 10 to 500 nm, for example, 20 nm, 30 nm, 50 nm, 90 nm, 100 nm, 150 nm, 200 nm, 300 nm, 400 nm, 490 nm).

[0048] In a preferred embodiment of the present invention, the radiation conditions are conditions under X-ray irradiation. More specifically, X-rays with a wavelength range of 0.01 to 10 nm (for example, 0.02 nm, 0.05 nm, 0.10 nm, 0.2 nm, 0.3 nm, 0.5 nm, 1.0 nm, 2.0 nm, 3.0 nm, 5.0 nm, 9.0 nm, 9.9 nm) are selected to initiate the curing of the first coating 101.

[0049] In a preferred embodiment of the present invention, the isolation layer 102 is a release agent coating pre-fixed on the surface of the balloon 100. The release agent coating is fixed on the side wall surface of the balloon 100, and the surface after curing can be used to apply the first coating 101. The release agent coating is difficult to be infiltrated by the first coating 101, so the first coating 101 will not form obvious adhesion after curing and can be easily peeled off from the first coating 101.

[0050] Specifically, the release agent used in the present invention is a commercially available silicone oil-based release agent, which can form a smooth and difficult-to-wet surface on the surface of the balloon 100 after curing, thereby being easily separated from the cured first coating 101 .

[0051] In a preferred embodiment of the present invention, the isolation layer 102 is tightly attached to the side wall surface of the balloon 100, and is separated from the side wall of the balloon 100 after the first coating 101 is cured. More specifically, the isolation layer 102 is made of an elastic polymer material (such as polyethylene, polyurethane, silicone and polyamide, etc.), and the polymer material can undergo elastic deformation or plastic deformation. At the same time, the isolation layer 102 has no physical connection with the surface of the balloon 100, and only exists in physical contact.

[0052] When the balloon 100 expands, the isolation layer 102 expands with the balloon 100 and props up the inner wall of the blood vessel at the lesion, covering the first coating 101 to the lesion area, and then solidifies the first coating 101 by light or radiation. After the curing is completed, the medium is discharged from the proximal end of the first catheter 200 to shrink the balloon 100. At this time, since the first coating 101 has been solidified, the isolation layer 102 is adhered to the inner wall of the blood vessel. On the one hand, the first coating 101 is separated from the balloon 100 to avoid adhesion, and on the other hand, it can further cover the lesion area, so that the plaque cannot fall off from the area covered by the isolation layer 102.

[0053] The present invention provides a one-stop neurointerventional treatment photocrosslinking stabilization device. When in use, a first coating 101 is firstly coated on the surface of a balloon 100, and then a delivery catheter 300 is placed therein. Figure 2As shown, the inner diameter of the delivery catheter 300 should reserve a certain space to prevent the first coating 101 from being scratched when the balloon 100 passes through the delivery catheter 300. The balloon 100 can be loaded into the delivery catheter 300, and then extended out of the delivery catheter 300 and coated with the first coating 101 before being retracted into the delivery catheter 300, which can reduce scratching. The delivery catheter 300 is then used to deliver the device to the lesion, and the balloon 100 can be released for subsequent treatment.

[0054] The one-stop photo-crosslinking stabilization device for neurointerventional treatment of the present invention is described in detail below through specific embodiments.

[0055] Example 1

[0056] like Figures 1-2 As shown, this embodiment provides a one-stop neurointerventional treatment photocross-linking stabilization device, including a balloon 100. The proximal end of the balloon 100 is connected to a first catheter 200. Physiological saline can be injected into the balloon 100 through the first catheter 200 to fill the balloon 100. The side wall of the balloon 100 is provided with an uncured first coating 101. The first coating 101 is in a gel state. When the light conditions of the environment in which the first coating 101 is located reach a preset range, curing occurs.

[0057] When the atherosclerotic part of the blood vessel is dilated by the above device, Figures 5 to 8 As shown, the first coating 101 is first applied to the surface of the balloon 100, and then the delivery catheter 300 is inserted. After the balloon 100 is pushed to the lesion through the delivery catheter 300, the delivery catheter 300 is withdrawn to expose the balloon 100, and then physiological saline is injected through the proximal end of the first catheter 200 to gradually fill the balloon 100 and contact the blood vessel wall. At this time, the first coating 101 gradually covers the inner wall of the blood vessel in contact with the balloon 100, including the plaque on the surface of the inner wall of the blood vessel. Subsequently, the optical fiber bundle 201 is inserted through the proximal end of the first catheter 200 along the inner cavity of the first catheter 200 until the optical fiber bundle 201 enters the balloon 100, and then the optical fiber bundle 201 releases ultraviolet rays with a wavelength of 10 to 400 nm to solidify the first coating 101.

[0058] After the first coating 101 is cured, the optical fiber bundle 201 is pulled out, and then physiological saline is discharged from the proximal end of the first catheter 200 to shrink the balloon 100, so that the balloon 100 can be recovered and the first coating 101 can be retained on the inner wall of the blood vessel to fix the plaque on the inner wall of the blood vessel and prevent it from falling off.

[0059] To prevent the first coating 101 from adhering to the surface of the balloon 100, Figure 3 As shown, an isolation layer 102 is provided between the first coating layer 101 and the balloon 100 , so as to separate the first coating layer 101 from the balloon 100 .

[0060] The isolation layer 102 is fixed on the side wall surface of the balloon 100 and is peeled off from the first coating 101 after the first coating 101 is cured. More specifically, the isolation layer 102 is a release agent coating pre-fixed on the surface of the balloon 100. A smooth isolation layer 102 is formed on the surface of the balloon 100 in advance using a silicone release agent, which can effectively prevent the cured first coating 101 from adhering to the surface of the balloon 100.

[0061] Example 2

[0062] As shown in the figure, this embodiment provides a one-stop neurointerventional treatment photocross-linking stabilization device, including a balloon 100. The proximal end of the balloon 100 is connected to a first catheter 200. Physiological saline can be injected into the balloon 100 through the first catheter 200 to fill the balloon 100. The side wall of the balloon 100 is provided with an uncured first coating 101.

[0063] The difference between this embodiment and embodiment 1 is that the composition of the first coating 101 is a mixture of berberine, epoxy resin, and vinyl ether resin, such as Fig. 9 As shown, the first coating 101 is cured when it is irradiated with X-rays having a wavelength of 0.01 to 10 nm, but is not cured or hardly cured when it is irradiated with visible light or ultraviolet light alone.

[0064] Through the above arrangement, when curing the first coating 101, this embodiment uses X-rays to irradiate the lesion from outside the body, so that the first coating 101 is quickly cured, and then the balloon 100 can be deflated and recovered.

[0065] Example 3

[0066] This embodiment provides a one-stop neurointerventional treatment photocrosslinking stabilization device, which is improved on the basis of embodiment 1. The difference is that Figure 4 As shown, the isolation layer 102 is not a release agent coating, but a layer of flexible material that is tightly attached to the side wall surface of the balloon 100. After the first coating 101 is cured, it is separated from the side wall of the balloon 100 and remains on the inner wall of the blood vessel.

[0067] Specifically, in this embodiment, the isolation layer 102 is made of an elastic polymer material that can undergo elastic deformation or plastic deformation. The polymer material in this embodiment is a polyurethane material. In other embodiments, the isolation layer 102 can also be made of materials such as polyethylene, silicone and polyamide.

[0068] The isolation layer 102 in this embodiment has good adhesion to the first coating 101, which can prevent the first coating 101 from falling off the surface of the isolation layer 102 under blood flow erosion. In some embodiments, the outer surface of the isolation layer 102 can be physically or chemically treated to make it easier to combine with the components of the first coating 101.

[0069] After the first coating 101 is cured, as shown in the figure, the balloon 100 can be detached from the isolation layer 102 by shrinking the balloon 100, and then the isolation layer 102 remains on the inner wall of the blood vessel. Since the isolation layer 102 is elastic, it can bend with the blood vessel, so it has good wall adhesion and safety. In addition, in some embodiments, the inner wall of the isolation layer 102 can also be coated with anti-stenosis or anti-thrombotic drugs to prevent tissue hyperplasia and restenosis in the inner cavity of the isolation layer 102.

[0070] In summary:

[0071] The present invention arranges a curable first coating on the surface of the balloon, and can use the cured first coating to fix the plaque on the inner wall of the blood vessel, thereby avoiding the problem of plaque loosening and falling off due to balloon expansion, and ensuring that problems such as infarction or vascular stenosis will not occur at the distal end of the lesion after the expansion operation. The present invention also arranges an isolation layer to make it difficult for the first coating to adhere to the balloon surface, which is conducive to the separation of the first coating from the balloon after curing.

[0072] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A one-stop neurointerventional treatment optical cross-linking stabilization device, comprising a balloon, the proximal end of which is connected to a first catheter, characterized in that: The side wall of the balloon is provided with an uncured first coating, and when the light condition or radiation condition of the environment in which the first coating is located reaches a preset range, curing occurs; An isolation layer is provided between the first coating layer and the balloon, and the isolation layer is used to separate the first coating layer from the balloon.

2. The one-stop neurointerventional treatment photocrosslinking stabilization device according to claim 1, characterized in that: The illumination condition is a condition under visible light or ultraviolet light.

3. The one-stop neurointerventional treatment photocrosslinking stabilization device according to claim 1, characterized in that: The radiation conditions are conditions under X-ray irradiation.

4. A one-stop neurointerventional treatment photocrosslinking stabilization device according to any one of claims 1 to 3, characterized in that: The isolation layer is fixed on the side wall surface of the balloon and is peeled off from the first coating layer after the first coating layer is cured.

5. A one-stop neurointerventional treatment photocrosslinking stabilization device according to any one of claims 1 to 3, characterized in that: The isolation layer is closely attached to the side wall surface of the balloon, and is separated from the side wall of the balloon after the first coating is cured.

6. The one-stop neurointerventional treatment photocrosslinking stabilization device according to claim 2, characterized in that: The preset range is a wavelength of 10 to 500 nm.

7. The one-stop neurointerventional treatment photocrosslinking stabilization device according to claim 3, characterized in that: The preset range is 0.01 to 10 nm.

8. The one-stop neurointerventional treatment photocrosslinking stabilization device according to claim 4, characterized in that: The isolation layer is a release agent coating pre-fixed on the surface of the balloon, and the release agent is a silicone oil type release agent.

9. The one-stop neurointerventional treatment photocrosslinking stabilization device according to claim 5, characterized in that: The isolation layer is made of elastic polymer material, and the polymer material can undergo elastic deformation or plastic deformation.

10. The one-stop neurointerventional treatment photocrosslinking stabilization device according to claim 9, characterized in that: The polymer material includes at least one of polyethylene, polyurethane, silica gel and polyamide.

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