Vascular implantation apparatus for treating trigeminal neuralgia

Abstract

A vascular implantation apparatus for treating trigeminal neuralgia, comprising a stent body and anchoring parts arranged at both ends of the stent body. The stent body is configured to be implanted into a blood vessel to perform fine adjustment on the blood vessel by means of pushing, shifting, or pulling. The anchoring parts are configured to be fixed to the inner wall of the blood vessel. The intravascular implantation apparatus for deployment in a blood vessel near the intracranial trigeminal nerve has certain flexibility and supportiveness, and can finely adjust the morphology or course of the diseased blood vessel, thereby relieving compression of the trigeminal nerve to treat trigeminal neuralgia. The present invention has the advantages that the intravascular implantation apparatus can be delivered by means of vascular intervention, featuring small trauma, simple operation, and low environmental requirements. In addition, the present invention enables rapid patient recovery, achieves significant therapeutic effects, and avoids the drawbacks or adverse impacts associated with surgical procedures.

Description

A vascular implant device for treating trigeminal neuralgia TECHNICAL FIELD

[0001] The present invention belongs to the field of medical technology implants, in particular to a vascular implant device for treating trigeminal neuralgia. BACKGROUND

[0002] Trigeminal neuralgia is a kind of recurrent, paroxysmal, short and severe pain in the distribution area of trigeminal nerve, including forehead, scalp, eye, nose, lip, cheek, maxilla, mandible and other facial neuralgia, which is a common and most severe pain in neuralgia and is difficult to cure. Speaking, brushing teeth, washing face, chewing, swallowing and other actions, especially eating cold or hot food, can induce trigeminal neuralgia.

[0003] Trigeminal neuralgia has primary trigeminal neuralgia and secondary trigeminal neuralgia. Secondary trigeminal neuralgia is caused by organic lesions inside and outside the brain, such as tumors, inflammation and trauma in the adjacent parts.

[0004] Primary trigeminal neuralgia is the most common type of the disease, and the pathogenesis is not clear and the exact cause cannot be found. The widely accepted view is that the blood vessels (arteries or veins) compress the trigeminal nerve to cause dysfunction.

[0005] Primary trigeminal neuralgia is characterized by recurrent and short-term pain in the distribution area of trigeminal nerve. Most patients have unilateral pain, and a few patients have bilateral pain. The pain usually lasts for several seconds to several minutes. Because the nature of this pain is diverse, it is characterized by tearing, electric shock, cutting or needle-like, sudden onset and sudden cessation, each pain lasts for several seconds to several tens of seconds, and the interval is completely normal. When the attack is severe, there are ipsilateral facial muscle convulsions, facial flushing, lacrimation and salivation. It is often accompanied by redness, sweating, increased skin temperature, salivation, mydriasis, lacrimation, rhinorrhea, nasal mucosa hyperemia, increased salivation, lung distension, etc. on the affected side. Patients have severe pain and abnormal pain, which seriously affects the quality of life.

[0006] At present, the mature treatment methods for primary trigeminal neuralgia include drug treatment, radiofrequency therapy, gamma knife treatment, microballoon compression / ablation surgery and traditional Chinese medicine acupuncture, but some methods have the problems of unclear effect, invasiveness, large side effects, easy to cause complications, and inability to cure, etc.

[0007] In recent years, the microvascular decompression (MVD) of trigeminal nerve is advocated, which is the most safe and effective surgical method, and can relieve pain without causing sensory and motor disorders. The surgical incision is behind the ear, and the length is about 4 cm. A small bone window of 2 to 3 cm is cut on the skull. Under the microscope, the blood vessels that compress the trigeminal nerve are pushed away or a buffer pad is added to remove the compression of the blood vessels on the trigeminal nerve, so that the clinical symptoms are relieved. The complete pain relief rate of patients after surgery is more than 90%, but complications such as hearing loss and temporary facial paralysis may occur. At present, the microvascular decompression of trigeminal nerve is the most effective and has the lowest recurrence rate in the treatment of trigeminal neuralgia.

[0008] However, there is currently a lack of effective devices for treating primary trigeminal neuralgia by vascular intervention. SUMMARY

[0009] The purpose of the present application is to overcome the defects of the prior art, and provide a vascular implant device for treating trigeminal neuralgia.

[0010] In order to achieve the above purpose, the present application adopts the following technical scheme: a vascular implant device for treating trigeminal neuralgia, comprising: a stent body and an anchoring part arranged at both ends of the stent body; wherein the stent body is used for implanting into the blood vessel to finely adjust the pushing, moving or pulling of the blood vessel, and the anchoring part is used for fixing the implant device to the inner wall of the blood vessel.

[0011] Further, the stent body is a single metal wire, which is vertical or curved with a certain curvature, and the width range is 0.25-1.5 mm and the length is 5-20 mm.

[0012] Further, when the stent body is curved, the curvature angle rad of the stent body ranges from 0 to π.

[0013] Further, the anchoring part is formed by a metal wire, which is a single ring, a loop, a hook, a planar multi-turn spiral or a three-dimensional multi-turn spiral, and the outer diameter ranges from 0.3 to 3 mm and the length ranges from 0.5 to 5 mm.

[0014] Further, when the anchoring part is a single ring, a loop or a hook, it is formed by extending outward with the stent body axis as the center to form a 2 / 3 ring to a complete ring, and the plane of the ring is perpendicular to the axis of the stent body.

[0015] Further, when the anchoring part is a planar multi-turn spiral, a planar Archimedes spiral is formed outwardly with the center of the stent body axis as the center, the spiral plane is perpendicular to the axis of the stent body, and at least one complete circular ring spiral is formed outwardly with the center of the stent body axis as the center and radially, and the pitch h is in the range of 0 < h < 10d, d being the wire diameter.

[0016] Further, when the anchoring part is a three-dimensional multi-turn spiral, the spiral transitions outwardly to the outermost layer of the anchoring part with the center of the stent body axis as the center, the three-dimensional multi-turn spiral is parallel and coincides with the axis of the stent body, and the wire pitch h is in the range of 0 < h < 10d, d being the wire diameter, and the number of spiral turns q > 2.

[0017] Further, the stent body and the anchoring part are respectively selected to be connected coaxially with different diameter spiral columns, the spiral columns of the stent body and the anchoring part are connected transitionally with the same kind of wire material with different diameters, or are directly formed by laser engraving from metal pipes or rods; the overall length of the vascular implant device is 5-30mm, and the outer diameter is in the range of 0.3-3mm.

[0018] Further, the material of the vascular implant device is a shape memory alloy, such as nickel-titanium, cobalt-chromium or iron-based alloy, the bending strength E of the material is in the range of 200MPa ≤ E ≤ 900MPa, and the stiffness k is in the range of 40GPa ≤ k ≤ 210GPa.

[0019] Further, the stent body and / or the anchoring part are provided with developing points, the developing points are made of gold, tantalum or tungsten, and are combined on the stent and / or the anchoring part by welding, bonding, crimping, hinging or winding.

[0020] The implant device for intravascular implantation near the intracranial trigeminal nerve of the present application has certain flexibility and support, can fine-tune the morphology or direction of the diseased blood vessel, thereby relieving the compression on the trigeminal nerve, and treating trigeminal neuralgia. The advantage is that it can be implanted through vascular intervention, has small trauma, simple operation, and does not require high environment, the patient recovers quickly, and the effect is obvious, without the disadvantages or influence of surgical operation. BRIEF DESCRIPTION OF DRAWINGS

[0021] Fig. 1 is a structural schematic view of the vascular implant device for treating trigeminal neuralgia (the anchoring part is in the form of a single-turn circular ring (1a), a coil (1b) and a hook (1c)).

[0022] Fig. 2 is a structural schematic view of the vascular implant device for treating trigeminal neuralgia (the anchoring part is in the form of a planar multi-turn spiral).

[0023] Fig. 3 is a structural schematic view of the vascular implant device for treating trigeminal neuralgia (the anchoring part is in the form of a three-dimensional multi-turn spiral).

[0024] Figure 4 is a structural schematic diagram of a vascular implant device for treating trigeminal neuralgia according to an embodiment (the shape of the stent body and the anchoring part is selected from one of a spiral shape (a), a strip shape (b) or a tube shape (c)). DETAILED DESCRIPTION

[0025] For those skilled in the art to better understand the technical scheme of the present application, the technical scheme of the embodiments of the present application will be described clearly and completely below in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor should be within the scope of protection of the present application.

[0026] It should be noted that the terms "include" and "have" and any variations thereof in the specification and claims of the present application and the above-mentioned drawings are intended to cover non-exclusive inclusion, for example, a process, method, system, product or device including a series of steps or units does not have to be limited to only those steps or units clearly listed, but can include other steps or units not clearly listed or inherent to the process, method, product or device.

[0027] A vascular implant device for treating trigeminal neuralgia includes a stent body 1 and anchoring parts 2 arranged at both ends of the stent body. The stent body is used to implant into a blood vessel and to fine-tune the pushing, poking or pulling of the blood vessel. The anchoring parts are used to fix the implant device to the inner wall of the blood vessel.

[0028] As shown in Figure 1, the stent body is processed from a single metal wire, and the anchoring parts at both ends are in the form of a single ring (1a), a loop (1b), a hook (1c) and the like, which play the role of fixing the stent and anchoring to the inner wall of the blood vessel. The stent body plays the role of fine-tuning the pushing, poking or pulling of the blood vessel. The outer diameter of the anchoring part ranges from 0.3mm to 3mm, preferably from 0.8mm to 1.5mm; the wire diameter of the stent body ranges from 0.010 to 0.021 inches, preferably from 0.014 to 0.018 inches, and the length ranges from 5mm to 15mm, preferably from 8mm to 12mm; the overall length of the vascular implant device ranges from 5mm to 20mm, preferably about 10mm or from 8mm to 15mm.

[0029] The stent body can be vertical, which can straighten the excessively curved blood vessel, and the processing or shaping process is simple, and the placement process does not need to adjust the direction and posture in the axial rotation.

[0030] In another embodiment, the stent body can be in a micro-arc shape, enhancing or customizing the displacement effect of the blood vessel, and axial rotation adjustment can be needed during implantation to align the arc in a specific direction. When the stent body is in a micro-arc shape, the arc angle rad is in the range of 0 < rad < π.

[0031] In another embodiment, the anchoring part is a planar multi-turn spiral, as shown in FIG. 2. The spiral plane is perpendicular to the axis of the stent body and extends radially outward from the axis of the stent body as the center to form at least one complete circular spiral with a pitch (h) in the range of 0 < h < 10d, where d is the wire diameter.

[0032] In another embodiment, the anchoring part is a three-dimensional multi-turn spiral, as shown in FIG. 3. The spiral extends outward from the axis of the stent body as the center to the outermost layer of the anchoring part, and the three-dimensional multi-turn spiral is parallel and coincides with the axis of the stent body. The pitch h of the metal wire is in the range of 0 < h < 10d, where d is the wire diameter, and the number of spiral turns q > 2.

[0033] In another embodiment, as shown in FIG. 4, the stent body and the anchoring part are in one of the shapes of a spiral (4a), a strip (4b), or a tube (4c). The shapes can be woven by wires or laser engraved by metal tubes. Each shape can be used as a stent body and / or an anchoring part. The overall length of the blood vessel implant device is in the range of 5mm to 20mm, preferably about 10mm or 8mm to 15mm; the outer diameter is in the range of 0.3mm to 3mm, preferably 0.8mm to 1.5mm; and the length of the stent body is in the range of 5mm to 15mm, preferably 8mm to 12mm.

[0034] The anchoring part can be made flexible by using different metal materials or different cutting, heat setting, etc. to reduce the negative effects of local stress; the stent body can be made rigid to fully exert the "straightening", displacement or adjustment effect; and different structures or different types of metal materials can be combined by welding, bonding, crimping, hinging, etc.

[0035] In another embodiment, the stent body and / or the anchoring part is provided with a developing point 3. The developing point 3 can be arranged for the whole body of the blood vessel implant device, at both ends, in the middle, or a combination thereof. The developing material can be different from the stent material, such as tantalum, tungsten, etc., which can be combined on the stent by welding, bonding, crimping, hinging, etc. (as shown in FIG. 5).

[0036] Overall size:

[0037] The outer diameter of the blood vessel implant device is in the range of 0.3mm to 3mm, preferably 0.8mm to 1.5mm, covering the diameter of the superior cerebellar artery (which is the main compression blood vessel), the anterior inferior cerebellar artery, the trigeminal cerebellar artery, and the venous blood vessels near the trigeminal nerve.

[0038] The overall length of the vascular implant device is in the range of 5mm to 20mm, preferably about 10mm or 8mm to 15mm;

[0039] Material:

[0040] The stent body and the anchoring portion can be made of a single or multiple wires, such as nickel-titanium, cobalt-chromium, stainless steel, etc., preferably nickel-titanium wires, or a metal tube or rod, preferably a nickel-titanium tube, which are processed and shaped.

[0041] The bending strength of the material is in the range of 200MPa≤E≤900MPa, and the stiffness is in the range of 40GPa≤k≤210GPa

[0042] It should be understood that the present application is described by way of example only and modifications can be made while remaining within the scope and spirit of the present application. The above has described in detail the preferred embodiments of the present application. It should be understood that those skilled in the art can make many modifications and changes without creative effort based on the concept of the present application. Therefore, any technical solution obtained by logical analysis, reasoning or limited test based on the existing technology within the scope and spirit of the present application should be within the protection scope defined by the claims.

Claims

1. A vascular implant device for treating trigeminal neuralgia, characterized in that The application relates to a blood vessel implanting device, which comprises a support body and anchor parts arranged at both ends of the support body; wherein the support body is used for implanting into a blood vessel and finely adjusting pushing, stirring or pulling of the blood vessel, and the anchor parts are used for fixing the implanting device to the inner wall of the blood vessel. The support body is formed by a single metal wire and has a vertical shape or a curved shape with a certain arc, the width ranges from 0.25 to 1.5 mm, and the length ranges from 5 to 20 mm.

2. The vascular implant device for treating trigeminal neuralgia according to claim 1, characterized in that: When the support body is curved, the arc angle rad of the support body ranges from 0 to pi.

3. The vascular implant device for treating trigeminal neuralgia of claim 2, wherein: The anchor parts are formed by a metal wire and have a single-loop ring shape, a loop shape, a hook shape, a planar multi-loop spiral shape or a three-dimensional multi-loop spiral shape, the outer diameter ranges from 0.3 to 3 mm, and the length ranges from 0.5 to 5 mm.

4. The vascular implant device for treating trigeminal neuralgia of claim 2, wherein: When the anchor parts are in the single-loop ring shape, the loop shape or the hook shape, the anchor parts are formed by extending outward from the center of the shaft of the support body to form a ring open loop with 2 / 3 of a loop to a complete loop, and the plane of the ring open loop is perpendicular to the shaft of the support body.

5. The vascular implant device for treating trigeminal neuralgia of claim 3, wherein: When the anchor parts are in the planar multi-loop spiral shape, the anchor parts are formed by extending outward from the center of the shaft of the support body to form a planar Archimedes spiral, the spiral plane is perpendicular to the shaft of the support body, and the anchor parts are formed by extending outward from the center of the shaft of the support body to form a circular ring spiral with at least one complete loop, and the pitch h ranges from 0 to 10d (d is the diameter of the metal wire).

6. The vascular implant device for treating trigeminal neuralgia of claim 3, wherein: When the anchor parts are in the three-dimensional multi-loop spiral shape, the anchor parts are formed by extending outward from the center of the shaft of the support body to spiral to the outermost layer of the anchor parts, the three-dimensional multi-loop spiral is parallel to and coincides with the shaft of the support body, the pitch h of the metal wire ranges from 0 to 10d (d is the diameter of the metal wire), and the number of spiral turns q is greater than 2.

7. The vascular implant device for treating trigeminal neuralgia of claim 3, wherein: The support body and the anchor parts are respectively connected to spiral columns with different diameters and coaxial connection, the spiral columns of the support body and the anchor parts are connected and formed by changing the diameter of the same kind of metal wire material, or are directly formed by laser engraving from metal pipes and rods, the overall length of the blood vessel implanting device ranges from 5 to 30 mm, and the outer diameter ranges from 0.3 to 3 mm.

8. The vascular implant device for treating trigeminal neuralgia of claim 1, wherein: The material of the blood vessel implanting device is a shape memory alloy, such as a nickel-titanium alloy, a cobalt-chromium alloy or an iron-based alloy, the bending strength E of the material ranges from 200 MPa to 900 MPa, and the stiffness k ranges from 40 GPa to 210 GPa.

9. The vascular implant device for treating trigeminal neuralgia of claim 1, wherein: The support body and / or the anchor parts are provided with developing points, the developing points are made of gold, tantalum or tungsten, and are combined on the support body and / or the anchor parts by welding, bonding, pressure bonding, hinging or winding.

10. The vascular implant device for treating trigeminal neuralgia of claim 1, wherein: ​

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