CN107714243A - Self-expansion intranasal stent - Google Patents

Self-expansion intranasal stent Download PDF

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Publication number
CN107714243A
CN107714243A CN201710908515.5A CN201710908515A CN107714243A CN 107714243 A CN107714243 A CN 107714243A CN 201710908515 A CN201710908515 A CN 201710908515A CN 107714243 A CN107714243 A CN 107714243A
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China
Prior art keywords
stent
intranasal
nasal
sinus
drug
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CN201710908515.5A
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Chinese (zh)
Inventor
付亮辉
沈碧峰
朱大伟
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翎秀生物科技(上海)有限公司
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Priority to CN201710908515.5A priority Critical patent/CN107714243A/en
Publication of CN107714243A publication Critical patent/CN107714243A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0618Nose

Abstract

The invention discloses a self-expansion intranasal stent. The intranasal stent expands in a natural state, and an expansionary force can make the intranasal stent to be close to the inner wall of paranasal sinus or cavum nasi during expansion while the expansionary force does not excessively expand paranasal sinus or cavum nasi; the intranasal stent is matched with paranasal sinus with lesion anddivided into a near end, a waist and a far end in a natural expansion state, cross section of the near end is S1, cross section of the waist is S2, cross section of the far end is S3, and S2 is smaller than S1 and smaller than S3. The intranasal stent is used for treating rhinitis or nasosinusitis; after operation, the intranasal stent is embedded in paranasal sinus or cavum nasi with lesion to support the same and used for eliminating inflammation of the same and preventing mucosal adhesion of the same.

Description

自膨胀式鼻内支架 Intranasal self-expanding stent

技术领域 FIELD

[0001]本发明涉及治疗鼻-鼻窦炎的医疗器械领域,更具体地涉及一种自膨胀式鼻内支架。 [0001] The present invention relates to the treatment of nasal - sinusitis medical field instruments, and more particularly, to a self-expanding stent intranasal.

背景技术 Background technique

[0002]鼻腔和鼻窦位于颅脑下面,居于咽喉与口腔上方,坐落于两眼眶之间。 [0002] The nasal cavity and sinuses located below brain, residing above the throat and mouth, is situated between the two eyes. 鼻腔和鼻窦病变常向附近组织蔓延,因而会引起各种各样的并发症。 Nasal and sinus disease often spread to nearby tissue, which can cause a variety of complications. 通常鼻-鼻窦炎在鼻腔检查中发现,鼻道或嗅裂处有脓性分泌物,中鼻甲及中鼻道粘膜增厚或息肉样变。 Typically nose - sinusitis examination found in the nasal cavity, nasal or olfactory fissure purulent discharge, middle turbinate and nasal mucosal thickening or polypoid change. 对多发性鼻窦炎可作阴压置换疗法,对化脓性上颌窦炎可作上颌窦穿刺术。 For sinusitis may be a female pressure replacement therapy, purulent maxillary sinusitis maxillary sinus puncture may be made. 有鼻息肉、中鼻甲肥大、鼻中隔弯曲、腺样体肥大等机械性阻塞因素者,因妨碍鼻窦的通气和引流,使炎症难于治愈,可采用手术疗法,如鼻息肉摘除术、鼻中甲切除术、鼻中隔矫正术、腺样体切除术等,目前比较常用手术的是鼻内窥镜微创手术。 Nasal polyps, middle turbinate hypertrophy, septal deviation ATH and other factors by mechanical obstruction, obstructing sinus ventilation and drainage, so difficult to cure inflammation, surgical therapy may be employed, such as nasal polyp surgery, nasal A removal surgery, nasal surgery, adenoidectomy, at present, surgery is commonly used minimally invasive endoscopic surgery.

[0003]对药物治疗不理想的鼻-鼻窦炎患者,目前最常用、最有效的治疗手段是“功能性” 鼻窦开放术,如FESS、鼻窦球囊扩张术(Balloon Sinuplasty),目的是通过鼻窦自然开口重建鼻窦的通气和引流。 [0003] Drug therapy is not ideal for the nose - sinusitis patients, the most common and most effective treatment is a "functional" open sinus surgery, such as FESS, sinus balloon angioplasty (Balloon Sinuplasty), the purpose of the sinuses by natural opening of the sinus ventilation and drainage reconstruction.

[0004]手术是“功能性”鼻窦开放术,术后鼻窦或鼻腔内仍然有发炎的部位,可以通过生理盐水、药物冲洗。 [0004] Surgery is the "functional" open sinus surgery, postoperative sinus or nasal cavity there are still parts of the inflammation, can be washed by saline drugs. 但是这样的治疗只是短暂的,药物对发炎部位作用时间很短、作用区域有限,对炎症的治疗效果不佳。 However, such treatment is only temporary, the drug effect is very short on the site of inflammation, the active area is limited, poor treatment of inflammation. 而且手术后半个月时间内鼻窦和鼻腔粘膜容易出现黏连的情况,黏连会阻塞正常通气功能。 And two weeks after the surgery time sinuses and nasal mucosa where adhesion easily occurs, adhesions can block normal ventilatory function.

[0005] 因此,临床现缺少一种对鼻-鼻窦炎术后炎症及术后粘膜黏连有效的治疗手段。 [0005] Thus, the lack of a clinically now nose - sinusitis postoperative inflammation and postoperative mucosal adhesion effective treatment.

发明内容 SUMMARY

[0006] 本发明的目的在于提供一种自膨胀式鼻内支架,该鼻内支架用于治疗鼻-鼻窦炎, 在手术后将该鼻内支架植入病变鼻窦或鼻腔,对鼻窦或鼻腔进行支撑,用于消除鼻窦或鼻腔的炎症、防止鼻窦或鼻腔粘膜出现黏连。 [0006] The object of the present invention is to provide a self-expanding stent intranasal, intranasal scaffold for the treatment of nasal - sinusitis, after surgery the nasal sinuses or nasal lesion stenting, for sinus or nasal cavity support for eliminating or nasal sinus inflammation, the nasal or sinus mucosa appears to prevent adhesion.

[0007] 本发明提供了一种自膨胀式鼻内支架,具体地,所述鼻内支架为自膨胀式鼻内支架,所述鼻内支架在自然状态下膨胀,膨胀时有一个扩张力可以使所述鼻内支架紧贴鼻窦或鼻腔内壁,同时这个扩张力又不会过度扩张鼻窦或鼻腔;所述鼻内支架与病变鼻窦是相适形的,所述鼻内支架在自然膨胀状态下,分为近端、腰部和远端,其中,近端的横截面积为S1,腰部的横截面积为S2,远端的横截面积为S3,且S2<S1和S2<S3;优选地,S2<S1<S3。 [0007] The present invention provides a self-expanding stent intranasally, particularly, the stent is a self-expanding intranasal intranasal stent, the expansion of the stent intranasally in a natural state, it can have an expansion force upon expansion intranasal stent against the inner wall of the nasal cavity or sinus, while the expansion force without unduly expanding the sinus or nasal cavity; the nasal sinuses bracket lesion is conformable with the natural intranasal stent expanded state , is divided into a proximal waist and a distal end, wherein the proximal end of the cross-sectional area as S1, S2 waist cross-section, the distal end of the cross-sectional area S3, and S2 <S1 and S2 <S3; preferably , S2 <S1 <S3.

[0008] 需要说明的是,置于病变鼻窦或鼻腔内的所述鼻内支架在扩张状态下,其形状为沙漏型或蝴蝶型等,所述横截面是指垂直于沙漏型或蝴蝶型的所述鼻内支架的中心轴线, 且截面积最大的横截面。 [0008] Incidentally, the nasal or sinus lesions stent placed within the nasal cavity in an expanded state, the shape of a butterfly or hourglass like, refers to the cross-section perpendicular to the hourglass or butterfly type the intranasal central axis of the stent, and the sectional area of ​​the largest cross-section.

[0009] 在另一优选例中,所述鼻内支架的膨胀比为2-100;优选地,5_1〇〇;更佳地,5_5〇。 [0009] In another preferred embodiment, the expansion ratio of the stent intranasal 2-100; preferably 5_1〇〇; more preferably, 5_5〇. 所述鼻内支架的膨胀比很大,当鼻内支架放®的区域既有窄的又有宽的区;t或时,鼻内支架由于其自膨胀性能且膨胀比大,可以很好的膨胀到以上区域的内壁,且支撑以上区域。 The expandable stent intranasal ratio is large, when the discharge intranasal ® stent both narrow regions have a wide area; when t or, intranasal self-expandable stent due to its performance and the expansion ratio, can be well expanded to an inner wall above the area, and the area above the support.

[0010] 在另一优选例中,所述鼻内支架用于治疗病变的鼻窦(包括额窦、上颌窦、蝶窦、筛窦)和鼻腔,特别是用于治疗药物通常不容易到达的额窦。 Amount [0010] In another preferred embodiment, the scaffold for the treatment of nasal sinus disease (including frontal, maxillary, sphenoid, ethmoid) and nasal, particularly for the therapeutic agent is not always easy to reach sinus.

[0011] 在另一优选例中,所述鼻内支架的长度L1为l〇-l6〇mm;优选地,15-150mm;更佳地, 20-100mm〇 [0011] In another preferred embodiment, the length L1 of the stent intranasal l〇-l6〇mm; Preferably, 15-150mm; more preferably, 20-100mm〇

[0012] 在另一优选例中,所述鼻内支架的最大处的直径D1彡10mm,优选地,l5-3〇mm,更佳地,15-20mm。 [0012] In another preferred embodiment, the stent diameter D1 of intranasal San largest at 10mm, preferably, l5-3〇mm, more preferably, 15-20mm.

[0013] 在另一优选例中,所述鼻内支架的最小处的直径D2彡4mm,优选地,8-l5mm,更佳地,8-10麵。 [0013] In another preferred embodiment, the intranasal minimal stent diameter D2 at San 4mm, preferably, 8-l5mm, more preferably, 8-10 face.

[0014] 在另一优选例中,所述鼻内支架的腰部设有平直段,所述平直段的长度为L2为0mm <L2<L1;更佳地,5mm<L2<Ll;更佳地5mm<L2<Ll-5mm。 [0014] In another preferred embodiment, the holder is provided with a waist intranasal straight section, the length of the straight section of L2 is 0mm <L2 <L1; more preferably, 5mm <L2 <Ll; more good to 5mm <L2 <Ll-5mm.

[0015] 在另一优选例中,直径为D2的区域与直径为D1的区域连接时,可以是直线连接,也可以是圆弧连接,还可以是以其他任意形状进行连接。 [0015] In another preferred embodiment, the diameter D2 is the diameter of the region is the region D1 is connected, may be connected to a straight line, an arc may be connected, may be connected to another arbitrary shape is.

[0016] 需要说明的是,所述鼻内支架的横截面可为任意形状,优选地为圆形或椭圆形,所述鼻内支架的最大处的直径D1和最小处的直径D2是将所述鼻内支架的横截面的面积等效为同样面积的圆形所对应的直径。 [0016] Incidentally, the cross-sectional intranasal stent may be of any shape, preferably circular or oval shape, the smallest diameter D1 and diameter D2 at the maximum at the intranasal The scaffold is cross-sectional area of ​​said stent intranasal equivalent diameter of the circular area corresponding to the same.

[0017] 在另一优选例中,当直径为D2的区域与直径为D1的区域通过直线进行连接时,会形成一个夹角a,其中,0。 [0017] In another preferred embodiment, when the diameter D2 of a region with a diameter D1 region are connected by a straight line, will form an angle a, wherein 0. <〇<90°;优选地,10°<a<80°;更佳地,20°<a<70°。 <Square <90 °; preferably, 10 ° <a <80 °; more preferably, 20 ° <a <70 °.

[0018] 在另一优选例中,当直径为D2的区域与直径为D1的区域通过曲面进行连接时,曲线的各个点处的切线与水平线所成夹角为h其中,0°<P<90°;优选地,10°<P<80°;更佳地,20°<e<70°。 [0018] In another preferred embodiment, when the diameter of region D1 diameter D2 of a region are connected by a curved surface tangent to the horizontal at various points of the curve where an angle of h, 0 ° <P < 90 °; preferably, 10 ° <P <80 °; more preferably, 20 ° <e <70 °.

[0019] 在另一优选例中,在膨胀状态下,鼻内支架是关于中轴线或某个截面规则对称的形状。 [0019] In another preferred embodiment, in the expanded state, the stent is intranasal or a shape of the cross section of the axis of symmetry rules.

[0020] 在另一优选例中,在膨胀状态下,鼻内支架是适应病变的鼻窦或鼻腔的不规格的形状。 [0020] In another preferred embodiment, in the expanded state, the stent is adapted to the shape intranasal or nasal sinus lesion not specifications.

[0021] 在另一优选例中,所述鼻内支架从鼻腔进入,并被推送至病变的鼻窦或鼻腔中。 [0021] In another preferred embodiment, the intranasal stent from entering the nasal cavity and paranasal sinuses or pushed to the lesion in the nasal cavity.

[0022] 在另一优选例中,所述鼻内支架在不受外力压迫的膨胀状态下,其腰部横截面积是窦口截面的两倍以上。 [0022] In another preferred embodiment, the stent intranasally under external pressure from the expanded state, which is more than twice the cross sectional area of ​​the waist section of the ostium.

[0023] 在另一优选例中,所述鼻内支架在扩张状态下为两头大中间小的形状,例如:蝴蝶结型,沙漏型,工字型等。 [0023] In another preferred embodiment, the intranasal stent in an expanded state to a small two large intermediate shape, for example: bowtie, hourglass,-shaped and the like. 这样的形状可以让所述鼻内支架很好的位于鼻窦窦口而不移动到其他位置,这样可以精确的给需要药物治疗的病变部位给药。 Such a shape allows the nasal sinus stent positioned well sinus ostium and does not move to another location, so that the lesion can be precisely to the required medication administration.

[0024] 在另一优选例中,所述鼻内支架是生物相容材料,且是可降解的。 [0024] In another preferred embodiment, the intranasal scaffold is biocompatible material, and is degradable.

[0025] 在另一优选例中,所述鼻内支架的大部分甚至全部为可降解材料,仅有一小部分或没有金属材料。 [0025] In another preferred embodiment, the intranasal most or all of the stent is biodegradable materials, only a small or no metal material.

[0026] 在另一优选例中,所述鼻内支架中的可降解材料的占比为9〇% -1 〇〇%。 The proportion [0026] In another preferred embodiment, the intranasal scaffold material is degradable thousand and 9〇% -1%.

[0027] 在另一优选例中,所述鼻内支架为聚乳酸材料。 [0027] In another preferred embodiment, the intranasal stent material is polylactic acid. 这些材质的鼻内支架植入人体后, 最终降解成人体可新陈代谢的物质,对人体无毒、无积累,这样鼻内支架植入人体后,最终降解成人体可新陈代谢的物质。 These materials after intranasal stent implanted in the human, the human body can eventually degrades into metabolic substances, toxic to humans, no accumulation of such implants in humans after intranasal stent, the body can eventually degrades into the substance metabolism.

[0028] 在另一优选例中,所述鼻内支架附着有药物,所述药物用于治疗炎症。 [0028] In another preferred embodiment, the bracket is attached intranasal medicament for the treatment of inflammation.

[0029] 在另一优选例中,鼻内支架与病变的鼻窦或鼻腔组织紧贴接触,鼻内支架上携带的药物缓慢扩散到鼻窦和鼻腔的组织中,治疗有炎症的区域。 [0029] In another preferred embodiment, the stent close contact with the nasal sinuses or nasal tissue disease, carried on the slow diffusion of the drug to the stent intranasal sinus and nasal tissues, the treatment of inflammation area.

[0030] 在另一优选例中,鼻内支架携带药物,鼻内支架上的药物不会很快从人体内流失, 可在人体内存留足够长时间,可以扩散到需要消炎的病变组织,保证药物有效地对病变区域治疗。 [0030] In another preferred embodiment, intranasal stent carrying the drug, the drug on the stent without intranasal loss quickly from the body, a long time may be required to diffuse into inflammatory lesions in human for sufficient guarantee drugs effectively treat the lesion area.

[0031] 在另一优选例中,药物可以是消炎药物,如抗生素(如庆大霉素等);也可以是激素类药物(如地塞米松等);还可以是粘液稀释剂(桃金娘油、桉油精,柠檬烯及a-蒎烯)。 [0031] In another preferred embodiment, the drug may be anti-inflammatory drugs, such as antibiotics (e.g., gentamicin, etc.); hormones may be drugs (such as dexamethasone); mucus may also be diluent (Rhodomyrtus Mother oil, eucalyptol, a- pinene and limonene).

[0032] 在另一优选例中,所述鼻内支架设有载药体,所述载药体用于存储所述药物,所述载药体为以下任一结构或其组合:载药孔、载药槽以及涂层。 [0032] In another preferred embodiment, the intranasal drug-loaded stent is provided, the drug-loaded for storing said medicament, said carrier body is a drug or a combination of any of the following structures: drug hole drug loading slot and a coating.

[0033] 在另一优选例中,所述涂层的数量为一层或多层,多层所述涂层用于载有多种药物。 [0033] In another preferred embodiment, the number of the one or more layers of coating, said multilayer coating is used containing a variety of drugs.

[0034] 在另一优选例中,所述鼻内支架是中空结构,所述鼻内支架的侧壁为镂空结构,非镂空区域包括小梁和连接杆;所述小梁的数量为n个,其中,衫n<5〇,所述小梁的形状为以下任一形状或其组合:直线型、U型、V型、M型、W型、正弦曲线或不规则形状;相邻所述小梁之间通过所述连接杆连接;镂空区域的形状为以下任一形状或其组合:正方形,长方形、圆形、 菱形、梭型、不规则形状。 [0034] In another preferred embodiment, the intranasal stent is a hollow structure, the hollow side wall intranasal stent structure, non-hollow region comprises a connecting rod and a trabecular; the trabecular number is n wherein, shirt n <5〇, the trabecular shape or a combination of any of the following shapes: straight, U-shaped, V, M-type, W-type, sinusoidal or irregular shape; adjacent to the the connection between the connecting rod trabecular; hollow shaped region is one of the following or a combination of shapes: square, rectangular, circular, diamond, shuttle type, irregular shape.

[0035] 在另一优选例中,所述鼻内支架的壁厚为0 • 01 -2mm;优选地,0 • 05-0 • 2mm。 [0035] In another preferred embodiment, the stent wall thickness intranasal 0 • 01 -2mm; preferably, 0 • 05-0 • 2mm.

[0036] 在另一优选例中,所述小梁的宽度是0 • 01-2mm;优选地,0 • 05-0 • 2_。 [0036] In another preferred embodiment, the width trabecular 0 • 01-2mm; preferably, 0 • 05-0 • 2_.

[0037] 在另一优选例中,所述连接杆可连接在所述小梁的任意位置。 [0037] In another preferred embodiment, the connecting rod may be attached at any position of the trabeculae.

[0038] 在另一优选例中,所述鼻内支架包括用于压缩所述鼻内支架的输送导管。 [0038] In another preferred embodiment, the bracket includes means for compressing the intranasal intranasal stent delivery catheter.

[0039] 在另一优选例中,所述输送导管为中空长管,在初始状态下,所述鼻内支架被收缩于所述中空长管的内腔。 [0039] In another preferred embodiment, the delivery conduit is a hollow elongated tube, in the initial state, the nasal lumen of the stent is contracted to the length of the hollow tube.

[0040] 在另一优选例中,所述输送导管是一根pebax管。 [0040] In another preferred embodiment, the delivery conduit is a tube pebax.

[0041] 在另一优选例中,所述输送导管的外层是pebax管,内层是PTFE管。 [0041] In another preferred embodiment, the delivery catheter is pebax outer tube, an inner tube of PTFE.

[0042] 在另一优选例中,所述输送导管的外层是pebax管,内层是PTFE管并且管壁内嵌有金属(如不锈钢)丝或金属(如不锈钢)编织管。 [0042] In another preferred embodiment, the delivery catheter is pebax outer tube and the inner wall of the PTFE tube is embedded in a metal (e.g., stainless steel) wire, or a metal (e.g., stainless steel) braided tube.

[0043] 在另一优选例中,所述输送导管的尾部设一个导管座,用于操作者持拿输送导管时操作(如推拉、旋转输送导管)便利。 [0043] In another preferred embodiment, the delivery catheter tail provided a catheter hub, holding operation for the operator to take delivery catheter (e.g., push-pull, rotary delivery catheter) convenient.

[0044] 在另一优选例中,所述输送导管的夕卜径小于4mm,更优地,小于2.5mm〇 [0044] In another preferred embodiment, the delivery catheter Bu Xi diameter of less than 4mm, more preferably, less than 2.5mm〇

[0045] 在另一优选例中,所述输送导管的内径大于2mm,更优地,大于1mm。 [0045] In another preferred embodiment, the inner diameter of the delivery catheter is greater than 2mm, more preferably, greater than 1mm.

[0046] 在另一优选例中,所述输送导管的有效长度不小于140mm。 [0046] In another preferred embodiment, the effective length of the delivery catheter is not less than 140mm.

[0047] 在另一优选例中,所述鼻内支架包括引导导管,通过引导导管,将收缩有支架的输送导管输送到病变鼻窦或鼻腔区域。 [0047] In another preferred embodiment, the stent comprises intranasally guide catheter through the guide catheter, the stent delivery catheter contraction delivered to the nasal cavity or sinus lesion area.

[0048] 应理解,在本发明范围内中,本发明的上述各技术特征和在下文(如实施例)中具体描述的各技术特征之间都可以互相组合,从而构成新的或优选的技术方案。 [0048] It should be understood, in the range of the present invention, can be combined with each other between the technical features of the invention and in the following technical features (as described in Example) specifically described, thereby constituting a new or preferred technique Program. 限于篇幅,在此不再一一累述。 Due to space limitations, which is not eleven tired.

附图说明 BRIEF DESCRIPTION

[0049] 为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图做简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。 [0049] In order to more clearly illustrate the technical solutions in the embodiments or the prior art embodiment of the present invention, the following embodiments are briefly introduced to drawings or described in the prior art will be needed to be used embodiment Apparently, in the following description the drawings are only some embodiments of the present invention, those of ordinary skill in the art is concerned, without creative efforts, can derive from these drawings other drawings.

[0050] 图1-la、图l-2a、图l-3a、图l-4a、图1-5a、图l-6a、图l-7a是本发明一个实例中的处于扩张状态的自膨胀式鼻内支架的主视图; [0050] FIG. 1-la, FIG. L-2a, FIG. L-3a, FIG. L-4a, FIG. 1-5a, FIG. L-6a, FIG. L-7a self-expanding one example of the present invention in an expanded state formula intranasal front view of the stent;

[0051] 图1-lb、图l-2b、图l_3b、图l-4b、图l-5b、图l_6b、图l-7b是本发明一个实例中的处于扩张状态的自膨胀式鼻内支架的尺寸图; [0051] FIG. 1-lb, FIG. L-2b, FIG l_3b, FIG. L-4b, FIG. L-5b, FIG l_6b, FIG. L-7b is a self-expanding stent in an expanded state intranasal one example of the present invention FIG size;

[0052] 其中,图1-la与图1-lb是相对应的,图l-2a和图l_2b是相对应的,图i-3a和图卜3b 是相对应的,图l-4a和图1-4b是相对应的,图1-5a和图1-5b是相对应的,图1-6a和图l_6b是相对应的,图l_7a和图1-7b是相对应的。 [0052] wherein, FIG. 1-la and FIG. 1-lb are corresponding to FIG. L-2a and FIG l_2b is corresponding to FIGS i-3a and FIG Bu 3b is corresponding to FIG. L-4a and FIG. 1-4b is corresponding to FIGS. 1-5a and 1-5b are corresponding to FIGS. 1-6a and l_6b is corresponding to FIGS l_7a and 1-7b are corresponding.

[0053]图2是本发明一个实例中的引导导管的主视图。 [0053] FIG. 2 is a front view of one example of the guide catheter of the present invention.

[0054]图3是本发明一个实例中的鼻内支架收缩在输送导管内的结构示意图。 [0054] FIG. 3 is one example of the present invention in a schematic view intranasal stent constriction within the delivery catheter.

[0055]图4是本发明一个实例中的鼻内支架的小梁的结构示意图。 [0055] FIG. 4 is a schematic view of one example of the trabecular structure of the present invention intranasally stent.

[0056]图5a是本发明一个实例中的孔型载药的鼻内支架的结构示意图。 [0056] FIG. 5a is a schematic view of a grooved nasal drug-loaded stent of one example of the present invention.

[0057]图5b是本发明一个实例中的载药槽型载药的鼻内支架的结构示意图。 [0057] FIG 5b is a schematic view of the holder groove intranasal drug example of a drug of the present invention.

[0058]图5c是本发明一个实例中的涂层型载药的鼻内支架的剖面图。 [0058] Figure 5c is a sectional view type intranasal drug coated stent of the present invention, in one example.

[0059]图6是本发明一个实例中的引导导管进入鼻窦的示意图。 [0059] FIG. 6 is a schematic view of one example of the guide catheter of the present invention into the sinuses.

[0060]图7是本发明一个实例中的鼻内支架收缩在输送导管内并沿引导导管进入病变部位的结构示意图。 [0060] FIG. 7 is an example of the present invention in the contracted stent structural diagram intranasal delivery catheter along the guide catheter into the lesion.

[0061]图8是本发明一个实例中的输送导管后撤,鼻内支架伸出输送导管并开始自膨胀的结构示意图。 [0061] FIG. 8 is one example of the present invention, in retreat delivery catheter, intranasal stent delivery catheter and extending expandable structure diagram starts from.

[0062]图9是本发明一个实例中的鼻内支架完全伸出输送导管并膨胀扩张紧贴鼻窦区与的结构示意图。 [0062] FIG. 9 is an example of the present invention intranasally stent delivery catheter is fully extended and expanded structural diagram of expansion close contact with the sinus region.

[0063]图10是本发明一个实例中的引导导管、输送导管和推杆撤到体外,支架留在鼻腔内的结构示意图。 [0063] FIG. 10 is one example of the guide catheter of the present invention, and the push rod to withdraw the delivery catheter from the body, leaving the stent in the structural diagram of the nasal cavity.

[0064] 各附图中,各标示如下: [0064] In the drawings, each labeled as follows:

[0065] 卜支架; [0065] BU holder;

[0066] 2-引导导管; [0066] 2- guide catheter;

[0067] 3-输送导管; [0067] 3- delivery catheter;

[0068] 4-推杆; [0068] 4- push rod;

[0069] 5-小梁; [0069] 5- trabecular;

[0070] 6-载药孔; [0070] 6- drug loading aperture;

[0071] 7-载药槽。 [0071] 7- drug groove.

具体实施方式 Detailed ways

[0072]本发明人经过广泛而深入的研究,通过大量筛选,首次开发了一种自膨胀式鼻内支架,与现有技术相比,本发明的自膨胀式鼻内支架是自膨胀的,置入病变的鼻窦或鼻腔后会根据放置位置的大小自行膨胀,并且紧贴鼻窦或鼻腔内壁,适应复杂的鼻窦和鼻腔结构; 支架在扩张状态下是两头大中间小的形状,如沙漏型、工字型、狗骨头等形状。 [0072] The present invention After extensive and in-depth research, through mass screening, for the first time developed a nasal self-expanding stents, compared with the prior art, intranasal self-expanding stent of the present invention is self-expanding, expansion after implantation by itself or nasal sinus lesions according to the size of the placement position, and against the inner wall of the nasal cavity or sinuses, nasal sinuses and adapt to the complex structure; stents are two big middle small shape in an expanded state, such as hourglass, shape I-shaped, dog bones and so on. 这样的形状可以让支架很好的位于鼻窦窦口而不移动到其他位置,这样可以精确的给需要药物治疗的病变部位给药;此外,本发明的支架是可降解的,支架中附着有药物,药物可以治疗炎症,防止鼻腔或鼻窦口黏连等,支架通过输送导管在体外被压缩至很小的一个尺寸,利于支架在细小的鼻腔或鼻窦中穿行,在此基础上完成了本发明。 Such a shape allows the stent is positioned well sinus sinus ostium and does not move to another location, so that the lesion can be precisely need to administered drug therapy; in addition, the stent of the present invention is a biodegradable stent with a drug adhered , drugs to treat inflammation, nasal or sinus ostium to prevent adhesions and the like, is compressed by the stent delivery catheter in vitro to a small size, facilitates the stent or walking in the nasal sinuses fine, on the basis of completion of the present invention.

[0073]本发明提供了一种自膨胀式鼻内支架,它是一种具有特定结构的自膨胀式鼻内支架。 [0073] The present invention provides a self-expanding stent intranasal, which is a kind of self-expanding stents intranasal specific structure. 本发明的自膨胀式鼻内支架壁厚0.01-2_优选地,0.05-0.2mm,支架是镂空结构,非镂空区域是一条条的小梁,小梁的宽度是〇. 〇l-2mm;优选地,0.05-0.2mm,小梁的形状可以是直线型、U型、V型、M型、W型、正弦曲线或不规则形状等各种线型的任意一种或多种。 Intranasal self-expanding stent wall thickness 0.01-2_ the present invention preferably, 0.05-0.2 mm, the stent is a hollow structure, non-hollow region is a section of the trabecular, trabecular width of the square 〇l-2mm.; preferably, 0.05-0.2 mm, trabecular linear shape may be any one or more of various linear U-shaped, V, M-type, W-type, sinusoidal or irregular shape. 由连接杆将相邻小梁连接在一起,连接杆连接相邻的小梁时连接在小梁的任意位置。 A connecting rod adjacent trabecular connected together, is connected at an arbitrary position adjacent to the trabecular trabecular when connecting the connecting rod. 镂空区域的形状可以是正方形,长方形、圆形、菱形、梭型、不规则形状等各种形状的任意一种或多种。 The shape of the hollow area may be any one or more of various shapes of square, rectangular, circular, diamond, shuttle type, irregular, etc. [0074]在自然状态下支架可自行膨胀。 [0074] The self-expandable stent in a natural state. 膨胀时有一个扩张力可以使得支架紧贴鼻窦或鼻腔内壁,同时这个扩张力又不会过度扩张鼻窦或鼻腔。 There may be such a stent expanding force against an inner wall of the nasal cavity or sinus when inflated, while the expansion force without unduly expanding or nasal sinuses.

[0075]在扩张状态下,支架可以是直筒形状的,其扩张比很大,这样,当支架放置的区域既有窄的又有宽的区域时,支架由于其自膨胀性能且扩张比大,可以很好的扩张到以上区域的内壁,且支撑以上区域。 [0075] In the expanded state, the stent may be a straight shape, its expansion ratio is large, such that when both the narrow region have a wide area of ​​the stent placement, because of its self-expanding stents and expansion performance ratio, It may well expand to the inner wall of the above areas, and support more than one region.

[0076] 支架在扩张状态下还可以是两头大中间小的形状,如沙漏型、工字型、狗骨头等形状。 [0076] In the expanded state the stent may also be small two large intermediate shapes such as hourglass, I-shaped, dog-bone shape. 这样的形状可以让支架很好的位于鼻窦窦口而不移动到其他位置,这样可以精确的给需要药物治疗的病变部位给药。 Such a shape allows the stent is positioned well sinus sinus ostium and does not move to another location, so that the lesion can be precisely to the required medication administration.

[0077]支架总长度为L1,最大外径为D1。 [0077] The total length of the stent is L1, the maximum outer diameter of D1. 当支架不是直筒型时,其腰部可以比两头小,支架最小处的直径为D2;若腰部也有平直段时,平直腰部的长度为L2;直径为D2区域与直径为D1的区域连接时,可以是直线连接,也可以是圆弧连接,还可以是其他任意形状的连接;支架可以是关于中轴线或某个截面规则对称的形状,也可以是不规格的形状。 When the stent is not a straight type, which may be smaller than two waist, the smallest diameter D2 of the stent; if there waist straight section, straight length L2 of the waist is; diameter D2 region of the diameter D1 of the connection region may be a straight line connecting, may be connected to an arc, may also be connected to any other shape; the scaffold may be a cross-section on the axis or regular symmetrical shape, may be of the irregular shape.

[0078] 支架的总长L1可以是10-60mm;优选地,15_50mm;更佳地,20-40mm. [0078] The entire length L1 of the stent may be 10-60mm; Preferably, 15_50mm; more preferably, 20-40mm.

[OO79] 支架的最大外径D1可以是彡10mm;优选地,15-30mm;更佳地15-20mm。 [OO79] The maximum outer diameter D1 of the stent may be San 10mm; Preferably, 15-30mm; more preferably 15-20mm.

[0080] 支架最小处的直径D2可以是彡4mm;优选地,8-15mm;更佳地8-10mm。 [0080] The minimum diameter D2 at the support may be San 4mm; preferably, 8-15mm; more preferably 8-10mm.

[0081] 腰部平直长度L2可以是tom<L2<Ll;优选地,5_<L2<L1;更佳地,5_<L2< Ll-5mm〇 [0081] waist straight length L2 may be tom <L2 <Ll; Preferably, 5_ <L2 <L1; more preferably, 5_ <L2 <Ll-5mm〇

[0082] 连接直径为D2区域与直径为D1的区域是直线连接时,连线间会形成一个夹角a,0° <a<90°;优选地,10°<a<80。 Region [0082] Connection area diameter D2 of the diameter D1 of the straight line is connected between a connection will form an angle a, 0 ° <a <90 °; preferably, 10 ° <a <80. ;更佳地,20°<a<70°。 ; More preferably, 20 ° <a <70 °.

[0083]支架上可附着药物,支架在扩张状态下与鼻窦或鼻腔组织紧贴接触,支架上携带的药物缓慢扩散到鼻窦和鼻腔的组织中,治疗有炎症的区域。 [0083] The bracket may be attached to the drug, the stent in an expanded state close to the contact with the nasal or sinus tissues, carried on the slow diffusion of the drug into the tissue holder sinuses and the nasal cavity, the treatment of inflammation area. 药物可以是消炎药物,如抗生素(如庆大霉素等);也可以是激素类药物(如地塞米松等);还可以是粘液稀释剂(桃金娘油、桉油精,柠檬烯及a-薇烯)。 The drug may be anti-inflammatory drugs, such as antibiotics (e.g., gentamicin, etc.); hormones may be drugs (such as dexamethasone); mucus may also be diluent (myrtle oil, eucalyptol, limonene and a - Wei-ene).

[0084] 药物附着方式:可以在支架上雕刻好的载药孔中•,也可以在支架上雕刻好的载药槽中。 [0084] Drug attachment means: good drug loading can be carved on the holder • holes, may be a good drug grooves carved on the holder. 还可以是均匀的混合在支架本身或支架表面的涂层中,该支架可以有一层或多层,可以载有多种药物。 May also be mixed in a uniform coating of the stent itself or the surface of the stent, the stent may have one or more layers, it may carry a variety of drugs.

[0085] 支架可以是聚乳酸或金属合金等材质。 [0085] The support may be a polylactic acid or a metal alloy material. 当支架本身是聚乳酸时,可以在人体内降解。 When the stent itself is polylactic acid can be degraded in the human body. 聚乳酸在人体内直接降解为二氧化碳和水,可被人体吸收或排泄,对人体无毒、无积累。 The polylactic acid in the human body directly degraded to carbon dioxide and water can be absorbed by the body or excreted, toxic to humans, no accumulation. 这样支架植入人体后,最终降解成人体可新陈代谢的物质。 After such stent body, the human body can eventually degrades into the substance metabolism.

[0086] 这样支架上的药物既不会很快从人体内流失;而且药物在人体内存留的时间足够长,可以扩散到需要消炎的病变组织,保证药物有效地对病变区域持续治疗。 [0086] Such a drug on the stent neither quickly lost from the body; and drugs in the human for long enough, can spread to inflammatory lesions need to ensure effective and continuous medication for the treatment of the lesion area.

[0087]本发明的鼻内支架包括一个用于收缩支架的输送导管。 [0087] The present invention comprises intranasal stent for constricting a stent delivery catheter. 其为一个中空长管,支架收缩在该中空长官内腔。 Which is a long hollow tube, the hollow stent contracted Executive lumen. 其材质可以是一根pebax管;也可以是外层pebax管,内层pTFE管. 还可以是外j^pebax管,内层PTFE管,并且管壁内嵌有金属(如不锈钢)丝或金属(如不锈钢)' 编织官。 The material may be a tube pebax; may be pebax outer tube, the inner tube may also be pTFE j ^ pebax outer tube, an inner PTFE tube and the wall embedded metal (e.g., stainless steel) or a metal wire. (e.g., stainless steel) 'woven officer. 其尾部可以有一个导管座。 The tail can have a catheter hub. 输送导管的外径应小于4^,更优地,小于2 • 5m;内径大于2mm,更优地,大于1mm。 Should be less than the outer diameter of the delivery conduit 4 ^, more preferably, less than 2 • 5m; diameter greater than 2mm, more preferably, greater than 1mm. 输送导管的有效长度不小于MOmm。 The effective length of the delivery catheter is not less than MOmm. ' '

[0088]在鼻内支架的使用过程中,支架预先压小收缩在输送导管内,支架携带药物。 [0088] In the intranasal use stent, stent pre-pressure low shrinkage in the delivery catheter, the stent carrying the drug.

[0089]本发明的鼻内支架还包括引导导管。 [0089] The present invention further intranasal stent comprises a guide catheter. 通过引导导管,将收缩有支架的输送导管输送到病变鼻窦或鼻腔区域。 Through the guide catheter, the stent delivery catheter contraction delivered to the nasal cavity or sinus lesion area.

[0090]特别地,支架推出时,可以借助一个推杆,该推杆可以是与支架相连接的,也可以是与支架相互独立的。 [0090] In particular, the introduction of the stent may be by means of a push rod, the stent may be independent of the push rod may be connected to the bracket. 当推杆与支架相连接时,在推杆与支架相连接的地方有一个可解脱的部件。 When the push rod is connected to the holder, where the holder and the push rod connecting member has a relief. 通过该部件将推杆与支架解脱。 By this means the release push rod holder. 解脱方式可以是电解脱、机械解脱等。 Extrication may be an electrical relief, relief and other machinery.

[0091]电解脱时:推杆靠近支架有一个解脱处,解脱处无绝缘层、导电熔断。 [0091] When the electric relief: the plunger close to the holder at a free, non-release of the insulating layer, a conductive fuse.

[0092]机械解脱时:推杆中间是中空的,推杆中间有一个解脱杆。 [0092] The mechanical release: the middle of the push rod is hollow, the intermediate tappet has a release lever. 解脱杆的前端可以是弹性凸片或楔形锁紧块。 The front end of release rod may be elastic tabs or locking wedge blocks. 弹性凸片凸起卡紧支架尾部,当要解脱时解脱杆后撤,弹性凸片发生弹性变形与支架尾部脱离从而支架解脱。 Elastic tabs gripping bracket tail projections, when the release lever to release retreat, the elastic tabs elastically deformed tail from the bracket so that the bracket relief. 楔形锁紧块嵌在推杆与支架尾部装配处的缝隙中,卡紧支架;解脱时,解脱杆后撤,楔形锁紧块从装配处的缝隙中脱离,从而支架解脱。 Wedge lock assembly of the tail of the block embedded in the gap at the push rod holder, the clamping bracket; release time, release lever retreat, the wedge lock assembly block disengaged from the slot, thereby release the stent. [0093]当推杆与支架独立时,可以当支架到了需要放置的位置时,推杆从输送导管尾部伸入其内腔并往前推进,然后把支撑器推出收缩器内腔。 When [0093] When the independent push rod holder, when the stent is to be placed in the desired position, the push rod moving forward and aft from the delivery catheter extends into its lumen, and the lumen holder Release retractor.

[0094]推杆与支架相连接有一个优势,即当发现支架位置不太理想还需要再次调整时可以将支架重新回缩到输送导管内,然后调整位置后即可再次将支架推出到合适的位置支撑鼻窦或鼻腔内壁。 [0094] The push rod is connected to bracket has an advantage, i.e., when the location is not found over the stent also need to be adjusted again to the stent delivery catheter retracted again, and then again adjusted to the position the stent is introduced into a suitable the inner wall of the supporting position or nasal sinuses.

[0095]本发明的自膨胀式鼻内支架的技术实施过程为: [0095] The technical implementation of self-expanding stents of the present invention intranasally as:

[0096] a)选择合适的引导导管,到达病变的鼻窦或鼻腔区域。 [0096] a) select the appropriate guide catheter to reach the lesion or nasal sinus area.

[0097] b)通过推杆将支架往输送导管内拉,将支架收缩至输送导管内,通过引导导管,将收缩有支架的输送导管输送到病变鼻窦或鼻腔区域。 [0097] b) by the pusher to the stent delivery catheter pulled, the stent is contracted to the delivery catheter through the guide catheter, the stent delivery catheter contraction delivered to the nasal cavity or sinus lesion area.

[0098] c)到达病变区域后,输送导管后撤,通过推杆将支架推送到输送导管外,支架的远端由于自膨胀作用而先进行扩张。 After [0098] c) reaches the lesion area, withdraw the delivery catheter, the stent is pushed by the push rod outside the delivery catheter, the distal end of the stent is self-expanding action due to expand.

[0099] d)扩张后的支架紧贴鼻窦或鼻腔内壁。 [0099] d) after the stent expanded against the inner wall of the nasal cavity or sinus. 两头大中间小形状的支架位于鼻窦窦口, 支架两端的大头分别位于鼻窦口的内外腔,将支架腰部固定卡紧在鼻窦口处。 Two big middle small bracket located on the sinus shape sinus ostium, the bulk of both ends of the stent are located inside and outside the mouth of the sinus cavity, the bracket fixed latching waist at the mouth of the sinus.

[0100] e)将推杆、输送导管、引导导管撤出,支架留在人体内,手术完成。 [0100] e) the push rod, the delivery catheter, the guide catheter withdrawn, leaving the stent in the body, the procedure is complete.

[0101] 本发明的主要优点包括: [0101] The main advantages of the present invention comprises:

[0102] (a)鼻内支架在扩张状态下紧贴接触病变的鼻窦或鼻腔组织,鼻内支架为两头大中间小的形状,使得鼻内支架可以很好的位于鼻窦窦口而不移动到其他位置,这样可以精确的给需要药物治疗的病变部位给药。 [0102] (a) in an expanded state the stent intranasal close contact with diseased tissues or nasal sinuses, nasal stent to a small two large intermediate shape, so that the nasal sinus stent may be well positioned to move without sinus ostium other locations, this can give accurate lesion required medication administration.

[0103] (b)鼻内支架为可降解材质,在植入人体后,最终降解成人体可新陈代谢的物质, 对人体无毒、无积累。 [0103] (b) is a biodegradable material intranasal stent, after implantation in the human body, the human body eventually degrades into the substance may be metabolic, toxic to humans, no accumulation.

[0104] (c)鼻内支架上附着有药物,该药物可用于治疗炎症,且药物不会很快从人体内流失,可在人体内存留足够长时间,可以扩散到需要消炎的病变组织,保证药物有效地对病变区域治疗。 [0104] (c) adhered to the stent intranasal medicament useful for the treatment of inflammation, and the drug is not quickly lost from the body, the memory may remain in the body long enough, can diffuse into the diseased tissue needed anti-inflammatory, ensure effective drugs for the treatment of the lesion area. t0105] (d)输送导管在体外可将鼻内支架收缩至很小的一个尺寸,利于鼻内支架在细小的鼻腔或鼻窦中穿行。 t0105] (d) intranasal stent delivery catheter may be contracted in vitro to a small size, conducive to walk through the small brackets intranasal or nasal sinuses.

[0106]因此,本发明有效治疗鼻-鼻窦炎,在手术后将该鼻内支架植入病变鼻窦或鼻腔, 对鼻窦或鼻腔进行支撑,用于防止鼻窦或鼻腔粘膜出现黏连。 [0106] Accordingly, the present invention is effective in the treatment of nasal - sinusitis, after surgery the nasal sinuses or nasal lesion stenting, for supporting or nasal sinuses, the sinus or nasal mucosa for preventing adhesion occurs.

[0107]下面结合具体实施例,进一步阐述本发明。 [0107] The following embodiments with reference to specific embodiments, further illustrate the present invention. 应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。 It should be understood that these embodiments are illustrative only and the present invention is not intended to limit the scope of the invention. 此外,附图为示意图,因此本发明装置和设备的并不受所述示意图的尺寸或比例限制。 Moreover, the drawings are schematic, and thus the device of the present invention is not limited by the device size or limit on the schematic.

[0108]需要说明的是,在本专利的权利要求和说明书中,诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来,而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。 [0108] Incidentally, in the claims and specification of this patent, relational terms such as first and second and the like are only used to distinguish one entity or operation from another entity or operation, without some requiring or implying any actual relationship or order between these entities or operations. 而且,术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含,从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素,而且还包括没有明确列出的其他要素,或者是还包括为这种过程、 方法、物品或者设备所固有的要素。 Further, the term "comprising", "containing" or any other variation thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, article, or apparatus not include only those elements but not expressly listed further comprising the other elements, or further comprising such process, method, article, or apparatus inherent elements. 在没有更多限制的情况下,由语句“包括一个”限定的要素,并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。 Without additional restrictions, by the wording "include a" defining element does not exclude the existence of additional identical elements in the process comprises the element, method, article or apparatus.

[0109]实施例 [0109] Example

[0110]本实施例的自膨胀式鼻内支架可用于治疗病变的鼻窦(包括额窦、上颌窦、蝶窦、 筛窦)和鼻腔,特别是用于治疗药物通常不容易到达的额窦。 [0110] The present intranasal self-expanding stent embodiments may be useful in the treatment of sinus disease (including frontal, maxillary, sphenoid, ethmoid) and nasal, particularly for the therapeutic agent is not always easy reach of the frontal sinus. 本实施例的鼻内支架1为自膨胀式鼻内支架,该鼻内支架1在自然状态下可自行膨胀,膨胀时有一个扩张力可以使鼻内支架1紧贴鼻窦或鼻腔内壁,同时这个扩张力又不会过度扩张鼻窦或鼻腔,且鼻内支架i与病变鼻窦是相适形的。 Intranasal stent 1 of this embodiment is a self-expanding stent intranasally, the nasal self-expandable stent 1 may in their natural state, has an expansion force can be made intranasally or nasal sinus stent against the inner wall 1 when inflated, while the expansion force without unduly expanding the sinus or nasal cavity and nasal sinus stent i lesion relative conformable.

[0112] 鼻内支架1在扩张状态下为两头大中间小的形状,例如:蝴蝶结型,沙漏型,工字型等。 [0112] Intranasal stent 1 in an expanded state to a small two large intermediate shape, for example: bowtie, hourglass,-shaped and the like. 这样的形状可以让鼻内支架1很好的位于鼻窦窦口而不移动到其他位置,这样可以精确的给需要药物治疗的病变部位给药。 Such a shape allows the support 1 intranasally well positioned sinus sinus ostium and does not move to another location, so that the need to precisely lesion medications administered.

[0113]鼻内支架丨的膨胀比很大,当鼻内支架丨放置的区域既有窄的又有宽的区域时,鼻内支架1由于其自膨胀性能且膨胀比大,可以很好的膨胀到以上区域的内壁,且支撑以上区域。 [0113] Shu expandable stent intranasal large ratio, when both regions have a wide area of ​​the narrow nasal stent placement Shu, intranasal self-expandable stent 1 because of its performance and the expansion ratio, it can be well expanded to an inner wall above the area, and the area above the support. 本实施例的鼻内支架1的膨胀比为20。 Intranasal expandable stent 1 of the present embodiment than Example 20.

[0114]鼻内支架丨是中空结构,鼻内支架i的侧壁为镂空结构,非镂空区域包括小梁5和连接杆。 [0114] Shu intranasal stent is a hollow structure, the stent sidewall intranasal i is hollow structure, non-hollow region and connecting rod 5 comprises trabeculae. 小梁5的结构如图4所示,一个鼻内支架1中小梁5的数量为n个,其中,3<n<50,小梁5 的形状为V型;相邻小梁5之间通过连接杆连接,连接杆可连接在小梁5的任意位置;镂空区域的形状为菱形。 5 trabecular structure shown in Figure 4, a stent 1 intranasal small number of beams 5 is n, wherein, 3 <n <50, 5 trabecular shape is V-shaped; pass between adjacent trabecular 5 a connecting rod, connecting rod may be attached at any position of the trabecular 5; rhombic shape of hollow region. 鼻内支架的壁厚为0.1_,小梁的宽度是0.1mm。 The wall thickness of the stent is 0.1_ intranasal, trabecular width is 0.1mm.

[0115]如图l-la至图l-7b,鼻内支架1在扩张状态下,其形状为适应病变的鼻窦或鼻腔的两头大中间小的形状,例如:蝴蝶结型,沙漏型,工字型等。 [0115] FIG l-la to l-7b, intranasal stent 1 in an expanded state, the shape of the intermediate large to accommodate two small form or nasal sinus lesions, such as: bowtie, hourglass, word type. 这样的形状可以让鼻内支架1很好的位于鼻窦窦口而不移动到其他位置,这样可以精确的给需要药物治疗的病变部位给药。 Such a shape allows the support 1 intranasally well positioned sinus sinus ostium and does not move to another location, so that the need to precisely lesion medications administered.

[0116] 其中,鼻内支架1的长度L1为10-160mm;优选地,15-150mm;更佳地,2〇_l〇〇mm;鼻内支架1的最大处的直径D1彡10mm,优选地,15-30mm,更佳地,15-20mm;最小处的直径D2彡4麵;优选地,8-15mm;更佳地8-10mm;腰部平直长度L2可以是〇mm<L2<Ll;优选地,5刪<L2 <L1;更佳地,5mm<L2<Ll-5mm。 [0116] wherein a length L1 of the stent intranasal 10-160mm; Preferably, 15-150mm; more preferably, 2〇_l〇〇mm; San intranasal stent diameter D1 10mm at the maximum 1, preferably ground, 15-30mm, more preferably, 15-20mm; minimum diameter D2 at the surface of San 4; preferably, 8-15mm; more preferably 8-10mm; waist length L2 may be straight 〇mm <L2 <Ll ; preferably, 5 to delete <L2 <L1; more preferably, 5mm <L2 <Ll-5mm. 直径为D2的区域与直径为D1的区域是通过直线连接时,连线间会形成一个夹角a,0°<a<90°;优选地,l〇°<ct<80°;更佳地,20°<a<7〇°。 When the diameter D2 is the diameter of region D1, region are connected by straight lines, it will form a connection between the angle a, 0 ° <a <90 °; preferably l〇 ° <ct <80 °; more preferably , 20 ° <a <7〇 °. 直径为D2 的区域与直径为D1的区域是通过圆弧连接的。 D2 is a diameter of a region of diameter D1 through a circular arc region of the connection. 直径为D2的区域与直径为D1的区域通过圆弧进行连接时,圆弧曲线的各个点处的切线与水平线所成夹角为0(未示出),其中,〇°<P< 9〇°;优选地,1〇°<6<8〇。 Diameter region D2 to the diameter D1 of the region is connected by an arc, and a horizontal line tangent arcs at various points of the curve at an angle of 0 (not shown), wherein the square ° <P <9〇 [deg.]; preferably 1〇 ° <6 <8〇. ;更佳地,2〇°<0<7〇°。 ; More preferably, 2〇 ° <0 <7〇 °.

[0117]需要说明的是,鼻内支架的横截面可为任意形状,优选地为圆形或椭圆形,鼻内支架的最大处的直径D1和最小处的直径D2是将鼻内支架的横截面的面积等效为同样面积的圆形所对应的直径。 [0117] Incidentally, a cross-sectional intranasal stent may be of any shape, preferably circular or oval shape, the smallest diameter D1 and diameter D2 at the maximum at the horizontal scaffold is intranasal intranasal stent area equivalent diameter of the circular cross section corresponding to the same area.

[0118]鼻内支架1是生物相容材料,且是可降解的。 [0118] 1 intranasal stent material is biocompatible, and is degradable. 本实施例的鼻内支架1的材料为聚乳酸材料。 Intranasal stent 1 of the present embodiment is a material of polylactic acid material. 此种材质的鼻内支架1植入人体后,最终降解成人体可新陈代谢的物质,对人体无毒、无积累,这样鼻内支架1植入人体后,最终降解成人体可新陈代谢的物质。 Such materials after intranasal stent 1 implanted in the human, the human body eventually degrades into the substance may be metabolic, toxic to humans, no accumulation, so that after intranasal stent 1 implanted in the human, the human body can eventually degrades into the substance metabolism.

[0119]鼻内支架1附着有药物,药物用于治疗炎症。 [0119] intranasally holder 1 is attached with a drug, a medicament for the treatment of inflammation. 鼻内支架1在扩张状态下与病变的鼻窦或鼻腔组织紧贴接触,鼻内支架1上携带的药物缓慢扩散到鼻窦和鼻腔的组织中,治疗有炎症的区域。 1 against intranasal stent in an expanded state contacting the sinuses or nasal tissue disease, carried on a slow diffusion of the drug to the stent intranasal sinus and nasal tissues, the treatment of inflammation area. 鼻内支架1上的药物不会很快从人体内流失,可在人体内存留足够长时间,可以扩散到需要消炎的病变组织,保证药物有效地对病变区域治疗。 1 intranasal drugs on the stent will not soon lost from the body, can remain in the body long enough memory, can spread to inflammatory lesions need to ensure effective drugs for the treatment of the lesion area. 药物可以是消炎药物,如抗生素(如庆大霉素等);也可以是激素类药物(如地塞米松等);还可以是粘液稀释剂(桃金娘油、桉油精,柠檬烯及a-蒎炼)。 The drug may be anti-inflammatory drugs, such as antibiotics (e.g., gentamicin, etc.); hormones may be drugs (such as dexamethasone); mucus may also be diluent (myrtle oil, eucalyptol, limonene and a - pinene refining).

[0120]鼻内支架1设有载药体,载药体用于存储药物。 [0120] 1 is provided with intranasal drug-loaded stent, the drug carrier body for storing a medicament. 如图5a所示,鼻内支架1的载药体为载药孔6,载药孔6中可以装载存储药物,药物用于治疗炎症。 Shown, intranasal drug-loaded stent of FIG. 5a 1 6 holes drug, drug loading aperture 6 may be stored in a drug, a medicament for the treatment of inflammation.

[0121] 在另一优选例中,如图5b所示,载药体为载药槽7。 [0121] In another preferred embodiment, shown in Figure 5b, it is a drug-loaded drug groove 7.

[0122]在另一优选例中,如图5c所示,载药体为涂层,即在鼻内支架的外表面涂有载药层,载药层的数量没有特别的限制,根据需要可以为一层或多层,用于装载多种不同药物。 [0122] In another preferred embodiment, shown in Figure 5c, a coating drug-loaded, i.e., is coated with an outer layer of drug-loaded stent intranasally, the number of drug carrying layer is not particularly limited, and may be required one or more layers, for loading a plurality of different drugs. 本实施例中为三层,医院装载三种药物。 A three-layer embodiment of the present embodiment, loading the hospital three drugs.

[0123]如图3所示,本实施例还设有输送导管3,在体外,鼻内支架1通过输送导管3被收缩至很小的尺寸,利于鼻内支架1在细小的鼻腔或鼻窦中穿行。 [0123] As shown in FIG. 3, the present embodiment also has a delivery duct 3, in vitro, the stent 1 is contracted by the intranasal delivery conduit 3 to a small size, facilitates the stent 1 in the nasal or nasal sinuses fine walk through.

[0124]输送导管3为中空长管,在初始状态下,鼻内支架1被收缩于中空长管的内腔。 [0124] The delivery catheter is a hollow elongated tube 3, in the initial state, intranasal stent 1 is contracted in the interior space of the hollow elongated tube. 输送导管3是一根pebax管。 3 is a pebax delivery catheter tube. 输送导管3的外径为2mm,内径为1.5mm。 3 the outer diameter of the delivery catheter is 2mm, an inner diameter of 1.5mm. 输送导管3的有效长度为160mm〇 The effective length of the delivery conduit 3 is 160mm〇

[0125]如图2所示,本实施例还设有引导导管2,通过引导导管2,将收缩有鼻内支架1的输送导管3输送到病变鼻窦或鼻腔区域。 [0125] 2, the present embodiment is also provided with two guide catheter, guide catheter 2 through the delivery catheter 3 contraction sinus or nasal delivery to a lesion area of ​​a stent intranasal.

[0126]在具体实施过程中,先选择合适的引导导管2,将其送达病变的鼻窦或鼻腔区域(如图6所示);然后通过推杆4将支架1往输送导管3内拉,将支架1收缩至输送导管3内,通过引导导管2,将收缩有支架1的输送导管3输送到病变鼻窦或鼻腔区域(如图7所示);到达病变区域后,输送导管3后撤,通过推杆4将支架1推送到输送导管3外,支架1的远端由于自膨胀作用而先进行扩张(如图8所示);扩张后的支架1紧贴鼻窦或鼻腔内壁,两头大中间小形状的支架位于鼻窦窦口,支架1两端的大头分别位于鼻窦口的内外腔,将支架腰部固定卡紧在鼻窦口处(如图9所示);最后将推杆4、输送导管3、引导导管2撤出,支架1留在人体内,手术完成(如图10所不)。 [0126] In a specific embodiment of the process, to select the appropriate guide catheter 2 to be served or nasal sinus lesion area (FIG. 6); and the plunger 4 by the stent delivery catheter 1 to 3 Raney, 1 to shrink the stent within the delivery conduit 3, through the guide catheter 2, the contraction stent delivery catheter 1 to the lesion 3 sinus or nasal delivery area (shown in FIG. 7); lesion area after arrival, 3 withdraw the delivery catheter, 1 by the plunger 4 is pushed to the stent delivery catheter 3, the distal end of the stent due to an action of the first self-expanding expand (FIG. 8); a stent expanded against the inner wall of the nasal cavity or sinus, two large intermediate small shaped bracket positioned sinus sinus ostium, the stent 1 at both ends of the inner and outer chambers are located in the bulk of the sinus ostia, the bracket fixed to the waist at the sinus ostium clamped (FIG. 9); Finally, the push rod 4, the delivery conduit 3, 2 the guide catheter withdrawn, leaving the stent in the body 1, the procedure is completed (not shown in FIG 10).

[0127]在本发明提及的所有文献都在本申请中引用作为参考,就如同每一篇文献被单独引用作为参考那样。 [0127] The present application are incorporated in all documents mentioned herein incorporated by reference, as if each reference were individually incorporated by reference above. 此外应理解,在阅读了本发明的上述讲授内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。 Furthermore, it should be understood that, after reading the above teachings of the present invention, those skilled in the art that various changes or modifications may be made to the present invention, and these equivalents also fall within the present application as defined in the appended claims scope.

Claims (10)

1. 一种自膨胀式鼻内支架,其特征在于,所述鼻内支架为自膨胀式鼻内支架,所述鼻内支架在自然状态下膨胀,膨胀时有一个扩张力可以使所述鼻内支架紧贴鼻窦或鼻腔内壁, 同时这个扩张力又不会过度扩张鼻窦或鼻腔; 、 所述鼻内支架与病变鼻窦或鼻腔是相适形的,所述鼻内支架在自然膨胀状态下,分为近端、腰部和远端,其中,近端的横截面积为S1,腰部的横截面积为S2,远端的横截面积为S3,且S2<S1 和S2<S3。 A self-expanding stent intranasal, wherein said stent is a self-expanding intranasal intranasal stent, said stent in a natural state intranasally expansion, there is a nose expanding force upon expansion can cause the nasal or sinus stent against the inner wall, while the expansion force without unduly expanding the sinus or nasal cavity; the nasal sinuses or nasal lesions bracket and is conformable with the natural intranasal stent expanded state, is divided into a proximal waist and a distal end, wherein the proximal end of the cross-sectional area as S1, S2 waist cross-section, the distal end of the cross-sectional area S3, and S2 <S1 and S2 <S3.
2. 如权利要求1所述的鼻内支架,其特征在于,所述鼻内支架在扩张状态下为两头大中间小的形状。 2. The stent of claim 1 intranasally claim, wherein the shape of two big middle small intranasally in an expanded state of the stent.
3. 如权利要求1所述的鼻内支架,其特征在于,所述鼻内支架是生物相容材料,且是可降解的。 Intranasal stent according to claim 1, wherein the scaffold is biocompatible material intranasal, and are degradable.
4. 如权利要求3所述的鼻内支架,其特征在于,所述鼻内支架为聚乳酸或合金材料。 The intranasal holder as claimed in claim 3, wherein said stent is a polylactic acid or intranasally alloy material.
5. 如权利要求1所述的鼻内支架,其特征在于,所述鼻内支架附着有药物,所述药物用于治疗炎症。 5. The stent of claim 1 intranasally claim, wherein said stent is attached intranasal medicament for the treatment of inflammation.
6. 如权利要求5所述的鼻内支架,其特征在于,所述鼻内支架设有载药体,所述载药体用于存储所述药物,所述载药体为以下任一结构或其组合:载药孔、载药槽以及涂层。 6. intranasal stent according to claim 5, wherein said holder is provided with intranasal drug carrier body, the carrier body for storing the medicament drug, the drug substance is one of the following structures or combinations thereof: drug hole, groove and drug coating.
7. 如权利要求1所述的鼻内支架,其特征在于,所述鼻内支架是中空结构,所述鼻内支架的侧壁为镂空结构,非镂空区域包括小梁和连接杆;所述小梁的数量为n个,其中, 50,所述小梁的形状为以下任一形状或其组合:直线型、U型、V型、M型、¥型、正弦曲线或不规则形状;相邻所述小梁之间通过所述连接杆连接;镂空区域的形状为以下任一形状或其组合:正方形,长方形、圆形、菱形、梭型、不规则形状。 7. The stent of claim 1 intranasally claim, wherein said stent is a hollow structure intranasal, intranasal the stent sidewall is hollow structure, the hollow region comprises a non trabeculae and connecting rod; the trabecular number is n, wherein 50, the trabecular shape or a combination of any of the following shapes: straight, U-shaped, V, M-type, ¥ type, sinusoidal or irregular shape; phase It is connected by the connecting rod between the trabecular o; hollow shaped region is one of the following or a combination of shapes: square, rectangular, circular, diamond, shuttle type, irregular shape.
8. 如权利要求1所述的鼻内支架,其特征在于,所述球囊支架包括用于压缩所述鼻内支架的输送导管。 8. The stent of claim 1 intranasally claim, wherein said stent comprises a balloon for compressing the stent delivery catheter intranasal.
9. 如权利要求8所述的鼻内支架,其特征在于,所述输送导管为中空长管,在初始状态下,所述鼻内支架被收缩于所述中空长管的内腔。 9. The stent according intranasal claim 8, wherein the delivery conduit is a hollow elongated tube, in the initial state, the stent is contracted to the nasal hollow interior of the tube length.
10. 如权利要求8所述的鼻内支架,其特征在于,所述输送导管是一根Pebax管。 10. The stent according intranasal claim 8, wherein the delivery conduit is a tube Pebax.
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EP2638871A1 (en) * 2004-04-21 2013-09-18 Acclarent, Inc. Devices and systems treating sinusitus and other disorders of the ears, nose and/or throat
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EP2638871A1 (en) * 2004-04-21 2013-09-18 Acclarent, Inc. Devices and systems treating sinusitus and other disorders of the ears, nose and/or throat
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