CN102256658A - 额窦垫片 - Google Patents
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/24—Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
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- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
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- A61B17/3421—Cannulas
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- A—HUMAN NECESSITIES
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- A61F—FILTERS 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
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- A61M25/00—Catheters; Hollow probes
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- A61M2025/1043—Balloon catheters with special features or adapted for special applications
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- A61M25/00—Catheters; Hollow probes
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- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
Abstract
本发明公开了物质递送垫片装置,所述垫片装置可以包括可扩张式贮存器,所述贮存器在鼻旁窦和其他腔体、开口和身体通道中为可植入的贮存器,以保持不闭合并提供持续的治疗或诊断物质的局部递送。本发明提供了递送设备,所述递送设备包括细长的管状构件以及可成形远侧部分和无创伤顶端。本发明也提供了窦穿透装置和系统,以用于进行筛窦切开术或用于在鼻旁窦或其他解剖结构的壁中生成其他开口。
Description
相关专利申请
本专利申请为共同待审的美国专利申请12/100,361(提交于2008年4月9日,名称为“Ethmoidotomy System And Implantable Spacer DevicesHaving Therapeutic Substance Delivery Capability For Treatment Of ParanasalSinusitis”(用于治疗鼻旁窦炎的筛窦切开系统和具有治疗性物质递送能力的可植入的垫片装置))的部分继续申请;共同待审的美国专利申请12/100,361是共同待审的美国专利申请11/544,009(提交于2006年10月4日,名称为“Implantable Devices and Methods for Treating Sinusitis andOther Disorders”(用于治疗鼻窦炎和其他疾病的可植入的装置和方法))的部分继续申请;共同待审的美国专利申请11/544,009是序列号为11/234,395的申请(提交于2005年9月23日,名称为“Devices andMethods for Delivering Therapeutic Substances for the Treatment of Sinusitisand Other Disorders”(用于递送治疗鼻窦炎和其他疾病的治疗性物质的装置和方法))的部分继续申请;序列号为11/234,395的申请是序列号为11/037,548的申请(提交于2005年1月17日,名称为“Devices,Systemsand Methods for Treating Disorders of the Ear,Nose and Throat”(用于治疗耳鼻喉疾病的装置、系统和方法))的部分继续申请;序列号为11/037,548的申请是序列号为10/912,578的申请(提交于2004年8月4日,名称为“Implantable Device and Methods for Delivering Drugs and OtherSubstances to Treat Sinusitis and Other Disorders”(用于递送治疗鼻窦炎和其他疾病的药物和其他物质的可植入的装置和方法))的部分继续申请;序列号为10/912,578的申请是序列号为10/829,917的申请(提交于2004年4月21日,名称为“Devices,Systems and Methods for Diagnosing andTreating Sinusitis and Other Disorders of the Ears,Nose and/or Throat”(用于诊断和治疗鼻窦炎和其他耳、鼻和/或咽喉疾病的装置、系统和方法))的部分继续申请;每一份该专利申请的整个公开内容均明确地以引用方式并入本文中。
技术领域
本发明整体涉及医疗器械和方法,更具体地讲,本发明涉及用于治疗广泛的疾病(包括(但不限于)鼻窦炎和其他耳鼻喉疾病)的递送物质植入物和方法。
背景技术
鼻旁窦需要足够的通气,以抑制窦腔内的微生物慢性感染。通常,通过称为“窦口”的小的自然开口进行通气,窦腔通过该开口通到鼻腔中。除了通气之外,当窦腔内表面的纤毛细胞将粘液流连续地导向窦口时,自然口还起到引流通道的作用。因此,当自然口变得狭窄或堵塞时,从窦腔通气和引流被削弱。由此导致的窦腔内的缺氧、pH变化和粘液淤滞产生某些类型的微生物可在其中迅速生长的环境。这种微生物感染本身还导致粘膜炎症,甚至还导致自然窦口缩窄或阻塞。
用于改善鼻旁窦通气和引流的技术
功能性内窥镜鼻窦手术(FESS)是一种常见类型的外科手术,在该手术中,内窥镜被插入鼻内,外科医生在通过内窥镜观察的情况下可以取出患病或肥大的组织或骨骼,并且可以通过手术扩大窦口,以恢复鼻窦的正常通气和引流。
作为切除术的替代方式,在一些患者中,球囊导管可以被推进到缩窄的窦口内并用于扩张窦口,从而不需要切割或移除围绕窦口的组织(Balloon SinuplastyTM技术,Acclarent,Inc.(Menlo Park,California))。此类球囊扩张手术的实例在美国专利申请公开No.2006/0004286、No.2006/0063973、No.2006/0210605、No.2007/0129751、No.2007/0135789、No.2007/0167682、No.2007/0208252、No.2007/0208301和No.2007/0293727中有所描述,每一份该专利申请的整个公开内容均明确地以引用方式并入本文中。
植入支架和占位材料来阻止术后再闭合
当与窦口相邻的组织已通过外科手术移除或切除时,术后疤痕组织、纤维变性、息肉病或组织向内生长可导致窦口再闭合。为了阻止额窦和蝶窦在术后的这种再闭合,已经将术后保留有限时间段的小管状支架设置在通过手术改变的窦口或流出道中。
市售的额窦支架的一个实例是FreemanTM Frontal Sinus Stent(FreemanTM额窦支架)(InHealth Technologies,Inc.(Carpinteria,California))。FreemanTM支架包括硅管,该硅管在任一端上均具有凸缘,以在术后所需的时间段内将支架保留在额窦流出道内。其他市售的额窦支架包括Jasin Frontal Sinus Stent(Jasin额窦支架)(Medtronic Xomed,Inc.(Jacksonville,Fla.))和Salman FES Stent(Salman FES支架)(Boston MedicalProducts(Westborough,Mass.))。
蝶窦支架在美国专利No.7,235,099(Duncavage等人)中有所描述。该支架包括在一端上具有通常半球形中空穹顶的柔软可压缩塑性管。穹顶直径为大于塑性管的预定直径。该支架还包括位于距半球形穹顶预定距离处的环状凸缘。该装置被设计成通过经手术扩大的蝶窦口装配,使得穹顶驻留在窦腔内,并且凸缘邻接围绕窦口的骨壁。该支架起到使通过手术改变的窦口在术后期间保持不闭合的作用,并且允许通过支架内腔冲洗/抽吸。该蝶窦支架也可作为SP-82020 Sphenoid Sinus Stent(SP-82020蝶窦支架)(Micromedics,Inc.(St.Paul,Minnesota))商购获得。
上述额窦支架和蝶窦支架不递送治疗性物质。因此,这些支架常常与口服药物(如皮质类固醇)和/或局部鼻腔喷剂同时使用。
在一些情况下,作为支架的替代,外科医生可以将凝胶状材料放置在通过手术改变的窦口或流出道内,以抑制疤痕组织在术后期间向内生长。此类材料的一个实例是得自Medtronic ENT,Inc.(Jacksonville,Florida)的MeroPackTM Bioresorbable Nasal Dressing and Sinus Stent(MeroPackTM生物可吸收鼻腔敷料和鼻窦支架)。MeroPackTM材料由80%的酯化透明质酸和20%的胶原组成。该材料在其干燥状态下插入,并且水合时在约6秒内溶胀成直径为1.0cm的材料。该材料在其水合状态下时为生物相容性粘膜粘附性凝胶。
治疗鼻窦疾病过程中的局部药物递送
已经提出在鼻旁窦中或其周围使用各种药物递送植入物,以治疗鼻窦炎和/或阻止通过手术改变的流出道或窦口在术后再闭合。
例如,美国专利申请公开No.20050043706(Eaton等人)描述了用于治疗鼻窦炎的可生物降解的植入物,此类植入物具有的尺寸、形状、密度、粘度、和/或粘膜粘附性抑制其在预期治疗期间被鼻窦的黏膜纤毛衬里基本上清除。这些可生物降解的植入物递送诸如抗生素、类固醇或这两者的治疗剂。这些可生物降解的植入物可以具有各种形式,诸如杆状、粒料、小珠、带状、或微粒,并且可以在各种药用载体中被递送到鼻窦中。
另外,美国专利申请公开No.20070005094(Eaton等人)描述了可用于治疗鼻旁窦疾病的可植入的装置。该装置包括腔体构件,该腔体构件具有允许该装置穿过窦口的第一收缩构型和在设置在窦腔中之后的第二扩张构型。除了腔体构件之外,该装置还可以包括鼻腔部分和能够驻留在窦口内的窦口构件。腔体构件连接到窦口构件的远端。鼻腔部分连接到窦口构件的近端并位于鼻道内。可以将活性剂渗入到该装置的所有部分中、或仅包括在可扩张式腔体构件、窦口构件或鼻腔部分中。
一些研究者已提出为额窦支架增加药物递送能力,以在额窦手术之后将受控量的药物递送到通过手术改变的流出道。例如,美国专利申请公开2004/0116958A1(Gopferich等人)描述了由可生物降解或不可生物降解的聚合物形成的管状护套或“垫片”,该护套或“垫片”在插入额窦流出道之前填充受控量的活性物质,诸如皮质类固醇或抗增殖剂。在额窦中进行形成开口的手术之后,护套(已预填充活性物质)被插入手术形成的开口中,并且:a)阻止手术形成的开口闭合;b)充当导管,以有利于从鼻窦引流;和c)递送活性物质。在一些实施例中,护套由多层聚合材料形成,护套的一层或多层填充活性物质,并且护套的一层或多层不含活性物质。在其他实施例中,护套具有形成其中包含活性物质的贮存器系统的“中空主体”,以及控制活性物质从贮存器释放的膜。在一些实施例中,可以通过使护套末端延伸到鼻窦中溶胀或以其他方式扩大来锚固护套。另外,美国专利申请公开No.2005/0245906(Makower等人)描述了包括可定位在窦口内的垫片的可生物降解的聚合物装置。该垫片具有多个药物洗脱撑条。该装置可以被植入,使得撑条基本上平行于粘液沿窦腔壁的纤毛流,以使得正常的黏膜纤毛传送不被中断。
另外,已经提出在鼻腔和/或鼻旁窦中使用的各种其他类型的可植入的药物递送装置。例如,美国专利No.3,948,254(Zaffaroni)描述了具有微孔壁的可植入的药物递送贮存器。该贮存器可以由可渗透药物通道的固体药物载体形成,并且药物从微孔壁的通过速率可以比药物穿过形成贮存器的固体药物载体的速率缓慢。Zaffaroni也描述了该可植入的药物递送装置的多个应用,包括设置在鼻道中。具体地讲,Zaffaroni提出用于以可控速率将药物分配在鼻道内的鼻腔递送装置,其中该鼻腔装置由以下构成:(a)壁,该壁限定尺寸适于插入和设置在鼻道内的装置,并且由鼻腔可用的微孔材料形成;(b)贮存器,该贮存器被所述壁围绕并由可渗透药物的固体载体构成,并包含足够量的药物,以用于该装置以连续和受控的速率长时间计量从装置释放的药物;(c)液体介质,该液体介质通过微孔中充入的扩散可渗透药物通道;并且(d)其中该装置在处于鼻腔环境中时通过让来自载体的药物穿过并经液体到达装置外部来释放药物,以产生有用结果。美国专利No.3,948,254(Zaffaroni)的整个公开内容明确地以引用方式并入本文中。
另外,其他出版物也报道了将药物直接引入鼻旁窦中对治疗鼻窦炎有效。参见Tarasov,D.I.等人的Application of Drugs Based on Polymers in theTreatment of Acute and Chronic Maxillary Sinusitis,Vestn Otorinolaringol.Vol.6,Pages 45-7(1978)(“在治疗急性和慢性上颌窦炎过程中施用基于聚合物的药物”,《耳鼻喉科学通报》,第6卷,第45-47页(1978年))。另外,R.Deutschmann等人的A Contribution to the Topical Treatment of[Maxillary]Sinusitis Preliminary Communication,Stomat.DDR 26(1976),585-592(“对上颌窦炎进行局部用药治疗的贡献:研究动态”,《德国口腔医学》,第26卷(1976年),第585-592页)描述为了洗脱药物(具体地讲为氯霉素)而将再吸收药物递送库设置在上颌窦内。在该临床系列出版物中,水溶性明胶被用作载体,并在施用和作为团块引入鼻窦中之前与药物混合。由于该物质几乎没有机械完整性并在相对较短的时间范围内溶解,为实现治疗效果,作者建议该物质必须每2至3天灌注一次。明胶的替代形式可以是如美国专利No.6,398,758(Jacobsen等人)中提出的填充治疗性物质的海绵。在涉及靠着血管壁递送持续释放装置的该专利中,中空圆柱形海绵填充药物并被压贴血管壁。这在维持血液在内腔中间内流动的情况下,允许药物接触血管壁。还提供皮肤,以将药物导向到血管壁中,并抑制药物流入内腔中。虽然填充药物的海绵在其施用时的确允许一定程度的持续释放,但加载海绵所需的时间也与海绵洗脱药物的时间密切相关。因此,如果需要进行较长时间的递送,则必须采用附加的机制来控制其释放。
在专利文献中也有若干实例,其中一般已提出使用具有预先渗入到基质或聚合物中的药物的系统进行的各种持续释放机制。这些文献包括3,948,254(Zaffaroni)、US 2003/0185872A2(Kochinke)、WO 92/15286(Shikani)、和5,512,055(Domb等人)。通常,这些参考文献讨论可以用于构造持续递送药物载体的各种材料和结构,并提供对持续递送药物领域现状的良好概述。虽然这些参考文献设计的某些材料和方案对形成药物持续释放系统有帮助,然而,它们并未描述允许它们容易地适于本专利申请要实现的预期用途的具体方法、装置或结构。
可植入的药物递送装置的其他实例包括美国专利No.3,993,073、No.4,217,898、No.5,304,123、No.6,042,561、No.6,183,461、No.6,780,168和No.6,783,522中描述的那些,其中每份专利的整个公开内容均明确地以引用方式并入本文中。
用于治疗筛骨疾病的技术
迄今为止,支架和垫片相对于鼻部和鼻窦手术的应用很大程度上局限于在已将组织和骨骼切除或移除的手术之后在额窦流出道或蝶窦口中的设置。然而,当新的装置和方法可用于治疗其他类型的鼻腔和鼻窦疾病时,很可能需要适用于设置在不限于额窦流出道的多个位置处的鼻内或窦垫片和支架(具有或不具有药物洗脱能力)。
在现有技术中,患病的筛骨气房有时通过称为筛房切除术的手术进行治疗,其中在介于筛骨气房内部和鼻腔之间形成人造通道。在至少一些情况下,在这些人造筛房切除术通道内放置支架和/或递送药物或其他治疗性物质是可取的。为了实现这一目的,可以将浸泡药物的纱布条推入人造开口中,然后再取出。另外,就这一点而言,美国专利No.6,543,452(Lavigne)描述了鼻插管装置,该装置包括具有带凸缘远侧顶端的柔性管,在远侧顶端上凸缘通常形成箭头形。该装置的远侧顶端能够穿透组织(如穿透筛泡)达到所需位置(如筛骨气房内)。在插管装置的远侧部分形成开口,以使得通过柔性管注入的药物(如典型的类固醇)将流出柔性管并接触相邻区域(如患病的筛骨气房)。在一些情况下,可以初始插入套管-套管针,然后将鼻插管装置穿过该套管-套管针推进。另外,欧洲专利公布EP0624349(Milewski)描述了具有根据解剖形状成型的球囊的带球囊顶端的导管,该球囊可以经手术形成的开口插入体腔(如额窦或筛房)中并充气,以通过成形为适合腔体的解剖形状而形成填塞。
用于治疗额窦的技术
上述各种难题也具体地与对额窦的治疗有关。另外,由于额窦的独特解剖结构,存在附加的困难。也就是说,可能需要专门的工具来进入额窦。此外,已经发现的是,对额窦进行常规的FESS手术具有更高的结疤趋势。这种结疤会导致引流和通气不足的复发。
虽然已经发现皮质类固醇可以有效减少额窦内的反应性结疤,但仍存在多个关键的局限。鼻腔喷剂和膏剂通常不能到达额窦流出道周围的临界区域。另外,可能难以将介入装置递送到额窦腔内较深处,并且存在与将介入器械保持在额窦流出道内相关的困难。
因此,仍然需要开发新的装置和方法,以用于在持续的时间内将药物和其他治疗或诊断物质递送到鼻旁窦、耳咽管、中耳和/或身体内的其他位置中,以用于治疗鼻窦炎、耳炎或其他疾病和紊乱。具体地讲,需要一种方法来便利有效地进入和治疗鼻窦(诸如额窦)。
本公开解决这些和其他需求。
发明内容
本发明提供了物质递送垫片装置和方法,该装置包括可扩张式贮存器,该贮存器可植入的鼻旁窦和其他腔体、开口和身体通道中,以保持不闭合和/或提供持续的治疗或诊断物质的局部递送。本发明也提供了用于在鼻旁窦或其他解剖结构的壁内形成筛窦切开术开口或其他开口的窦穿透装置、系统和方法。
在一种具体方法中,已经开发了用于具体治疗额窦的系统和方法。该系统可包括细长的可成形管或护套,该可成形管或护套能够通过患者解剖结构并呈现结构,以用于进入额窦。也开发了各种适用具有保持结构的物质递送垫片的方法。通过这种方式,可针对患者解剖结构中的差异进行补偿。另外,在一个方面,垫片装置可附加包括无创伤顶端,诸如由软质聚合物形成的顶端。
能够治疗额窦的物质递送垫片的一个实施例包括轴和连接到轴的远侧部分的可扩张式贮存器。该贮存器可以以收缩构型引入患者体内、安装到额窦,然后扩张。要扩张该贮存器,可将诸如药物或其他治疗性物质之类的物质填充在贮存器内。另外,贮存器可具有开口,通过该开口可洗脱药物或治疗性物质,从而治疗额窦。此外,当把垫片留在介入位点处时,可将轴切割成所需长度。该垫片还可包括能够有利于将垫片固定在额窦处或额窦内的保持结构。就这一点而言,可设想沿着贮存器的各个部分延伸的一个或多个保持翼。这种保持翼可呈现用于递送到介入位点的压缩构型和用于将垫片固定在解剖结构内的扩张构型。
用于治疗筛窦炎的装置和方法的一个实施例涉及穿透装置,该穿透装置具有远侧顶端和位于邻近其远侧顶端一定距离的止动标记或构件。介于止动标记或构件与远侧顶端之间的距离为小于介于筛泡和同侧蝶窦之间的距离。通过将穿透器以不垂直于颅底并通常朝同侧蝶窦引导的方向推进穿过筛泡,而形成筛窦切开术通道。当止动标记或构件与筛泡大约齐平时,穿透器停止推进。随后,移除穿透器。任选地,可以接着将支架、垫片或物质递送垫片装置设置在筛窦切开术通道中一段时间,以保持通道不闭合和/或对治疗性物质进行局部递送。
根据一个实施例,窦穿透装置和方法可以用来在鼻旁窦壁或其他身体结构中形成筛窦切开术通道或其他开口。这种装置包括细长的穿透构件和在其近端处或其近端附近与穿透构件连接的柄部。观察构件被沿柄部或细长构件设置在某个位置处,以便在细长构件的远端插入患者体内时可以从体外有利位置进行观察。这种观察构件可由装置使用者使用,以在所需方向上通常瞄准位于患者体内的穿透器远端。在一些实施例中,观察构件可以具有翅片。观察构件可以在基本上平行于细长穿透器从柄部延伸的平面的平面内延伸,并且任选地可以包括另一个构件(如十字构件),该构件基本上垂直于细长穿透器从柄部延伸的平面。在一些实施例中,细长穿透器可以具有形成于其中的弯曲部,并且观察构件的至少一部分可以平行于细长穿透器远离弯曲部的部分,从而提供对细长穿透器的远侧部分推进的方向或轨线的指示。
根据本发明还提供物质递送垫片装置和方法。在一个实施例中,该物质递送垫片装置包括轴和位于轴上的可扩张式贮存器。该贮存器可以在收缩构型下引入体腔或开口(如鼻旁窦、筛窦切开术通道、额窦流出道、或其他体腔、开口、通道)中。然后,可以将治疗性物质填充到贮存器中,从而导致贮存器就地扩张。可以将该轴在所需位置处切断或切割,并且轴的近侧部分可以在填充贮存器之后移除。贮存器设计成使得物质会在一段时间内从贮存器洗脱。贮存器可以具有侧壁和锥形末端,并且在侧壁和锥形末端中形成开口,使得填充到贮存器中的治疗性物质会穿过开口从贮存器洗脱。在一些实施例中,该装置可以配有用于将贮存器保持在体内所需位置中的设备(如保持翼、凸起、缝线套环等),以用于将贮存器保持在体内所需位置中。
根据本发明还提供方法和系统,其中具有上述特征的物质递送垫片装置与鼻窦穿透器(如上述筛窦切开术装置或任何其他穿透器)和护套联合使用。首先将护套设置在鼻窦穿透器上方,并将穿透器/护套组合推进穿过鼻旁窦或气房的壁。然后移除穿透器,将护套留在适当的位置。物质递送垫片装置被推进到护套中。然后移除护套,将物质递送垫片装置留在鼻窦或气房内的适当位置中。然后,将诊断或治疗性物质填充到贮存器中,使得该物质将随后从贮存器洗脱到鼻旁窦或气房中。
根据本发明还提供用于治疗鼻窦炎的方法的实施例,其中具有物质洗脱贮存器的可植入的装置设置在鼻旁窦内或在鼻旁窦的窦口或流出道内。然后,将类固醇引入物质洗脱贮存器中,以使得类固醇以治疗鼻窦炎的有效量从贮存器洗脱。
在阅读下文示出的具体实施方式和实例时,将理解本发明的更多方面和细节。
附图说明
图1示出与内窥镜结合使用以治疗受试人的本发明的垫片装置。
图2为本发明的垫片装置的一个实施例的侧视图。
图2A为图2装置远侧部分的放大纵切面视图。
图2B为图2装置远侧部分在将物质输注到装置贮存器部分中期间的放大纵切面视图。
图2C为通过图2装置近侧套节的纵切面视图。
图2D为约束护套处于回缩位置的图2装置侧视图。
图2E为约束护套处于推进位置的图2装置侧视图。
图2F为图2装置可扩张式贮存器的示意图。
图2G为图2F的区域2G的放大视图。
图2H为图2F的可扩张式贮存器的近端视图。
图3为组装了可选保持系统的本发明垫片装置另一个实施例的远侧部分侧视图。
图4为可与本发明的筛窦切开术针结合使用的护套的一个实施例的侧视图。
图5为本发明筛窦切开术针装置的一个实施例的侧视图。
图5A为通过图5筛窦切开术针装置的手持件远侧部分的纵切面视图。
图5B为图5筛窦切开术针装置的远端视图。
图5C为图5筛窦切开术针装置的远侧顶端侧视图。
图5D为组装了旋转毛刺顶端的本发明筛窦切开术装置的另一个实施例的侧视图。
图5E为图5D筛窦切开术装置的旋转毛刺顶端的放大侧视图。
图6为其上设置有图4护套的图5筛窦切开术针装置的侧视图。
图7A至图7K示出根据本发明的方法中的步骤,该方法用于进行筛窦切开术和根据筛窦切开术通道植入物质递送垫片装置。
图8A-8G示出根据本发明的方法中的步骤,该方法用于利用导向导管将图2的物质递送垫片装置植入受试人额窦的流出道内。
图9A-9D示出根据本发明的方法中的步骤,该方法用于利用图4的护套和可选的扩张器将图2的物质递送垫片装置植入受试人额窦的流出道内。
图10A示出根据本发明一个实施例的额窦物质递送系统。
图10B-10E示出根据本发明一个实施例的额窦物质递送装置和用于该装置的约束护套的多个视图和细部图。
图11A-11D示出额窦垫片装置的多个可供选择的实施例。
图12A示出根据本发明一个实施例的用于将物质递送装置引导到额窦中的导向装置。
图12B-12E示出类似于图12A装置的导向装置远端的多个视图和实施例。
图13A-13H示出用于治疗额窦的方法中的步骤。
图14A-14D示出在额窦内植入多种不同的垫片装置。
图15为曲线图,示出以下提及的14个受试人的Lund MacKay评分。
图16为直方图,示出以下提及的受试人在多个时间点处的平均SNOT20评分。
图17为本发明的物质递送/骨骼穿透螺钉装置的透视图。
图17A为示意图,示出植入覆盖有粘膜组织的鼻内骨骼结构的图17的物质递送/骨骼穿透螺钉装置。
图18为人头部的局部左/右矢状切面,示出具有深度控制止动构件的筛窦切开术针,该筛窦切开术针经受试者鼻孔插入,并推进到筛窦中,直到止动构件紧靠受试者鼻部,从而抑制针的进一步推进。
图19A-19D为组装了多层可扩张式贮存器的本发明的物质递送垫片装置的另一个实施例的多个视图。
具体实施方式
以下详细说明和附图旨在描述本发明的一些(但并非不可避免地是所有的)实例或实施例。本详细说明的内容不以任何方式限制本发明的范围。
图1至图2G示出本发明的可植入的物质递送装置和/或垫片10的一个实施例。装置10具有细长的柔性导管轴12,柔性导管轴12具有近侧部分12a和远侧部分12b,这两部分可以在间距标记物15处彼此切断。近侧轴部分12a和远侧轴部分12b可以由相同或不同材料形成,并且可以具有相同或不同尺寸(如直径、壁厚等)。例如,在旨在用于植入鼻旁窦或其他耳鼻喉位置中的一些实施例中,近侧轴部分12a可以由合适的生物相容性材料制成,该材料具有足够的裂断强度(如推送性),以允许使用者能够将物质递送装置10推入鼻旁解剖结构中。一种这样的材料是聚酰胺。在一些实施例中,远侧轴部分12b可以由更柔韧的生物相容性材料诸如尼龙或聚对苯二甲酸乙二醇酯(PET)制成。中央腔13连续地延伸穿过轴12。远侧轴部分12a可以渐缩或颈缩成直径比近侧轴部分小,以有利于装置的插入,如下文所述。塞子23安装在中央腔13的远端中。塞子23可以具有任何合适的闭合构件,诸如管上封闭端的壁、端盖、中央腔13末端内的团块或任何其他合适的阻流构件。在图中所示的具体实例中,塞子23具有设置在中央腔13远端内的生物相容性聚合物粘合剂。在一些实施例中,塞子23可以包括突出超过远侧轴部分12b的远端的柔软的无创伤(如球状或钝的)顶端构件。
可扩张式贮存器14以收缩构型安装在远侧轴部分12b上(在其远端附近),并且在被填充时扩张为扩张构型。此类贮存器14的一个实施例的细部图可见于图2A和图2B以及图2F、图2G和图2H。在该实施例中,贮存器14具有球囊,该球囊具有圆柱形侧壁,开口31在该壁中形成。贮存器14可以由任何合适的生物相容性材料形成,并且在一些实施例中,可以具有由非适形或半适形材料(诸如尼龙12)形成的球囊。在至少一些实施例中,优选的是贮存器的材料和壁厚为使得贮存器为足够柔性的,以:a)允许在不导致明显创伤的情况下将装置从身体抽出和移除;b)不迫使贮存器的所有内容物立刻流出;并且c)使开口31在贮存器扩张时保持基本上一致的尺寸。贮存器14的数量(诸如两个或更多个)、贮存器的尺寸和开口31的数量与尺寸可以根据旨在植入位置和/或效价、粘度、粒度(对于悬浮液)和/或被递送的物质的其他性质而变化。例如,在旨在穿过筛窦切开术通道并设置在筛骨气房内以治疗筛窦炎的装置10的一个实施例中,贮存器14的长度可以为从约0.5cm至约3.5cm并且典型地为大约2cm、直径可以为在完全扩张时约0.1cm至约0.5cm并且典型地为大约0.3cm。另外,根椐物质和预期的洗脱速率,可以存在任何合适数量的开口31。典型地,开口31的数量将介于约50和约5000之间,其直径尺寸设计为在约5微米至约80微米的范围内。
如下文进一步所述,贮存器14的该实施例可以以收缩构型插入身体开口、通道或腔体(例如为额窦流出道、鼻旁窦口、窦造口、筛窦切开术开口、或受试者耳鼻喉内的其他位置)中,并且随后可以将贮存器填充所需物质,从而导致贮存器过渡到扩张状态。例如,对于旨在使用上述具有图2F-2H所示开口尺寸/样式的具体贮存器14治疗鼻旁窦炎症的应用,贮存器14可以填充大约0.10ml的水性悬浮液,该悬浮液包含40mg/ml的曲安奈德可注射悬浮液USP(Kenalog-40,Bristol-Myers Squibb(Somerville,New Jersey))。这将引起在14天的时间内每天从贮存器洗脱大约100μg的曲安奈德。当用于治疗真菌性鼻窦炎或其他真菌感染时,该贮存器14也可以用于递送抗真菌剂,诸如可以商品名Amphocin抗真菌剂得自Pfizer的0.3mg/kg至1.5mg/kg的脂质体或非脂质体两性霉素B。全身施用的两性霉素在整个粘膜上典型地具有来自血流的有限分布,反之亦然。利用该物质递送装置10,两性霉素可以局部释放到存在引起疾病的真菌生物体的粘膜中,并且治疗浓度的药物在通过纤毛作用穿过鼻窦分布时可以保持在粘液中。然而,大量的两性霉素将不会通过鼻窦粘膜被大量吸收,从而避免了两性霉素出现全身不良效应(诸如肾毒性)的可能性。另外,该贮存器14可能能够将溶液以及悬浮液递送到围绕的解剖结构。由于大多数类固醇是以悬浮液形式提供,因此这尤其可用于递送类固醇。
另外,不需要在所有应用中将贮存器14用来递送治疗性物质。事实上,该贮存器可以用作占位装置(如代替鼻窦支架)。在这类应用中,贮存器14可以就地填充盐水溶液或其他惰性液体,从而导致贮存器14扩张并摩擦接合或接触相邻的解剖结构,从而在所需植入位置处提供一定程度的保持。可以通过在贮存器上设置表面凸起来进一步促进贮存器14的这个方面。在贮存器14旨在发挥作用的情况下
贮存器14在处于其收缩构型时的直径可以为相对较小,从而允许将其容易地引入或移除。在贮存器14由非适形或半适形材料形成的实施例中,贮存器14在填充过程中将不会发生较大的弹性变形,因而不会对其内容物施加用于通过开口31排出所需物质的压力。相反,通过重力或通过接触因鼻窦中的纤毛作用而持续向前移动的粘液或血液,贮存器14中的物质将穿过开口31传递。这种非加压递送允许在数日内缓慢释放所需物质。在一些其他实施例中,贮存器14可以由具有小开口31的适形或弹性材料形成,使得当物质递送到开口31以外时形成球囊14的材料将收缩,从而维持球囊内的压力。当贮存器14旨在用于插入窦口、流出道、窦造口或筛房切除术/筛窦切开术开口中并用来递送含有40mg/ml的曲安奈德可注射悬浮液USP(Kenalog-40,Bristol-Myers Squibb(Somerville,New Jersey))的水性悬浮液或具有类似稠度的另一种物质时,贮存器14可以具有在贮存器14侧壁中形成的大约2200个直径为约20微米至40微米的激光切割开口31。如图2F-2H所示,开口31可以准直成纵向行,并且各个开口31的定位可以逐行交错。在该具体实施例中,介于各个开口之间的纵向距离D1为0.30+/-0.03mm,介于行之间的距离D2为0.68+/-0.1mm。另外,在该实例中,如图所示,贮存器具有限定贮存器工作长度的圆柱形侧壁14a、从圆柱形侧壁14a过渡到远侧轴12b(贮存器远侧)的远侧锥形物14b和从圆柱形侧壁14a过渡到远侧轴12b(贮存器近侧)的近侧锥形物14c、和延伸到近侧锥形物14c和远侧锥形物14b上的开口31。另外,在该实例中,贮存器14的总长度为约16mm、工作长度(即圆柱形侧壁14c的长度)为约13mm,并且可扩张到3.0mm至3.5mm的完全扩张直径。在贮存器14的侧壁14a中形成大约768个激光切割开口31。每一个激光切割开口31的直径为40微米。当填充0.31ml至0.35ml的40mg/ml的曲安奈德可注射悬浮液USP(Kenalog-40,Bristol-Myers Squibb(Somerville,New Jersey))时,这种具体的贮存器设计将在28天的时间内每天递送剂量为大约100μg的曲安奈德。
在图示的具体实例中,远侧轴部分12b可以由尼龙12制成,并且其外径可以为0.028英寸、内径为0.020英寸、长度为17mm。在导管轴12中形成如图1B-1C所示的小孔28,以有利于填充贮存器14。阀门26允许物质(或物质的组分)从导管轴12的中央腔13流入贮存器14中(参见图1C),但不允许从贮存器14大量回流到中央腔13中(参见图1B)。阀门26可以包括任何合适类型的单向阀。在图示的具体实施例中,阀门28包括由一段C-flex热塑性弹性体管材(Consolidated Polymer Technologies,Inc.(Clearwater,Florida))制成的弹性体套阀。
任选地,可以提供远侧射线不可透的标记物24和近侧射线不可透的标记物22,以有利于贮存器14在受试者体内的所需定位。这些标记物22、24中的每一个都可以由射线不可透材料的环制成,并且可以与贮存器的圆柱形侧壁14a的每一个末端都对齐地安装在轴12上。在该具体实例中,每一个标记物22、24都包括外径为0.034英寸、内径为0.030英寸的铂-铱合金带。这些标记物在包括荧光检查和CT扫描在内的多种成像技术下可见。
在图示实例中,近侧轴部分12a可以由外径为0.0618英寸、内径为0.052英寸和长度为20cm的聚酰亚胺管材制成。包括由透明聚碳酸酯制成的内螺纹鲁尔连接器(部件号41519,Qosina(Edgewood,NY))的套节16连接到轴12的近端。如图2C所示,该套节16具有渐缩至远侧孔102的近侧孔100,从而有利于输注悬浮液和粘稠的液体。远侧孔102的直径与轴中央腔13大约相同并与之连续。
另外,在图示实例中,该装置组装了两种类型的位置保持设备,即缝线套环20以及具有保持翼18的性质的一对凸起。保持翼18位于邻近贮存器14的轴12上的完全相对的位置处,以有助于将贮存器14保留在体内所需位置处,如下文更详细所述。在该实例中,每一个保持翼18都具有直径为0.0086英寸的镍-钛(镍钛诺)线材的预成形套环。每一个保持翼18都可以弯曲或压缩至收缩位置,在该位置处保持翼基本平坦地靠着轴12的外表面。然而,这些保持翼18被偏置成预成形构型,使得当不受约束时,每一个保持翼18都将有回弹力地向外弹向伸长位置,其中保持翼相对于轴12的纵向轴线成约65度至90度的角度延伸。通过将镍钛诺线材套环在520℃下热处理20分钟以产生20℃的奥氏体最终温度(Af),可以实现这些保持翼18的这种预成形。可以采用这些保持翼18的各种替代形式。例如,图3示出可供选择的保持构件88,该构件具有近侧有回弹力的弹性体凸缘90和远侧有回弹力的弹性体凸缘92,该近侧凸缘和远侧凸缘处于间隔开的位置处,以便抵靠并接合解剖壁或结构的相对侧。在图3中,解剖壁或结构包括由粘膜组织M覆盖的骨骼B形成的筛泡或鼻窦壁。远侧凸缘88为充分地有回弹力和柔性的凸缘,以在穿过解剖壁中的小开口时伸缩,并且随后恢复其如图3所示的扩张形状。
缝线套环20(如孔眼或环)可以由诸如缝线或镍-钛合金(镍钛诺)线材之类的柔软、柔性、有回弹力、弹性或超弹性的材料形成。在图示的具体实施例中,缝线套环由直径为0.0075英寸的黑色单丝尼龙非吸收性手术缝线材料形成。缝线套环20可以靠着轴12的外表面收缩。通过将线材或其他材料卷绕在轴12周围并使用合适的粘合剂(诸如氰基丙烯酸酯、环氧树脂或紫外光固化粘合剂)将线材固定到轴上,和/或通过将聚合物套管或可热收缩构件安装到卷绕在轴12周围的那部分线材周围,可以将缝线套环20附连到轴12的外表面上。在一些实施例中,缝线套环可以是彩色的,以便在视觉上与血液和粉红色的鼻腔内粘膜分辨开来。例如,缝线套环20可以是黑色、浅蓝色或绿色,以便可由外科医生易于定位。该缝线套环20可以缝合到相邻组织,以将装置10的远侧部分锚定在适当位置。
如图2D和图2E所示,可以在轴12上方设置管状约束护套30。在图示的具体实例中,该约束护套30包括长度为10cm的塑性管材,该塑性管材的外径为0.084英寸、内径为0.075英寸。该约束护套30在介于回缩位置(参见图2D)和伸长位置(参见图2E)之间为可来回移动的护套。当在伸长位置中时,约束护套在保持翼18、缝线套环20和收缩的贮存器14上方延伸,从而将保持翼18保持在其收缩位置中,并在保持翼18、缝线套环20和收缩的贮存器14上方形成平滑的保护性覆盖物。另外,当在伸长位置中时,约束护套30会增强整个装置的裂断强度,并且会阻止轴12在被推过相对狭窄和/或曲折的解剖通道时扭折。在装置10已被插入到所需位置后,可以将约束护套12撤回到其回缩位置,从而允许缝线套环20为可触及、保持翼18向外回弹至其伸长位置,并且贮存器14在随后填充所需物质时发生扩张。
虽然上述垫片装置10的具体实例包括由单层球囊形成的贮存器14,但在一些实施例中,贮存器可以包括具有多个层(每一层内具有不同尺寸的开口)的球囊。然后,可以将物质选择性地引入特定层之间,这将有利于以所需速率对该特定物质进行所需递送。就这一点而言,以举例的方式,图19至图19D示出具有轴612和多层贮存器球囊614的物质递送垫片装置610的另一个实施例。轴612可以按照与上述装置10的轴12相同的方式进行构造和装备。然而,在该实施例中,三个中央腔616、618和620延伸穿过轴612,并且贮存器614球囊,该球囊具有三个层614a、614b和614c。最外层614a具有第一尺寸的开口631a。中间层614b具有第二尺寸的开口631b,第二尺寸小于最外层614a中形成的开口631a的尺寸。最内层614c具有第三尺寸的开口631c,第三尺寸小于中间层614b中形成的开口631b的尺寸。第一中央腔616通往最内层614c内的空间。第二中央腔618通往介于最内层614c和中间层614b之间的空间。第三中央腔620通往介于中间层614b和最外层614a之间的空间。这样,操作者可以选择要将特定物质输注到其中的特定空间,以使得需要让该物质通过以下开口中的任一个:a)仅最外层614a中的开口631a;b)中间层614b中的开口631b以及最外层614a中的开口631a;或c)在所有三个层614a、614b和614c中的所有开口631a、631b、631c。这样,可以优化物质的洗脱速率。
如下文更详细所述,物质递送垫片装置10、610可以植入受试人或受试动物的身体的任何合适部分或位置中,以执行间距功能(如抑制组织向内生长、结疤、纤维变性、形成粘合等)和/或递送任何所需的治疗性物质。例如,在耳鼻喉应用中,可以将装置10、610植入自然口或在任何鼻旁窦或气房中形成的人造开口中或任何其他自然、经外科手术改变或经外科手术生成的开口或通道(诸如额窦流出道、下鼻道、上鼻道或中鼻道等)中。
图4-5E示出可以单独使用或与上述类型的物质递送垫片装置10、610结合使用的筛窦切开术系统的实例。该筛窦切开术系统包括图5所示护套40和图6所示鼻窦针60。护套40和鼻窦针60可以单独使用或联合使用。图6中示出护套40和鼻窦针60的组合。
护套40可以由诸如PEBAX之类生物相容性聚合物形成,并且包括第一直径的近侧护套主体42、第二直径(比第一直径小)的远侧护套主体44和在介于近侧护套主体42和远侧护套主体44之间的锥形渐缩段54。喇叭形区域46位于护套40的近端PE处。视觉标记带50任选地设置在近侧护套主体42上(在其近端PE附近)。第二视觉标记带48任选地位于远侧轴部分44上(距远端DE大约17mm)。另外任选地,可以在远侧护套主体44上间隔开的位置处设置射线不可透的标记物52、56。在图示的具体实例中,远侧射线不可透的标记物56位于距远端大约1.5mm处,近侧射线不可透的标记物52位于距远端DE大约17mm处并在视觉标记物48的远侧边缘下方。另外,在一些实施例中,可选的翼构件53可以在视觉标记物48的区域中从远侧护套主体44横向地延伸。这些可选翼构件53可以按照与上述物质递送垫片装置10的保持翼18基本上相同的方式构造,并且在伸展时,每一个翼构件53的长度都可以为约2cm。这些可选的翼构件53将紧靠相邻的解剖结构,以限制护套40可以推入身体内的开口或通道内的距离。该护套40可以用来促进上述物质递送垫片装置10的插入,或该护套40可以单独用来促进物质的吸入或用于递送治疗或诊断物质。
在图5所示实施例中,鼻窦针60具有细长的弯曲针主体62,该主体具有锋利的套管针尖63。针主体62的近端固定、不可旋转地锚定到手持件64。如图5A所示,通过在针主体62的近端中形成90度的弯头,并将弯头模铸到手持件64内的适当位置中,从而形成强效连接并抑制针主体62相对于手持件64旋转,可以实现上述目的。在附图所示实施例中,针主体48由外径为大约0.07英寸的实心不锈钢线材形成。在针主体62中形成弯曲部65。针主体62的长度为约102mm,并且弯曲部65的中心位于距针主体62的远侧顶端63约31mm处。弯曲部65形成大约33度的角度A2。鼻窦针60的该具体实施例尤其适用于下述针筛窦切开术,并且弯曲部52允许针主体62的远侧部分推进穿过筛泡并进入筛骨气房中,并降低不利地穿透保护受试者脑部的相邻颅底的可能性。另外,如放大视图图5B和图5C所示,在该实例中,套管针尖63具有围绕针轴的中心轴线对称布置的三个倾斜边缘,每一个倾斜边缘都设置成相对于针主体62的纵向轴线成约20度的角度B。该设计允许鼻窦针装置60能够用于穿透软组织(如粘膜)以及薄骨骼(如筛泡和分隔各个筛骨气房的其他骨骼)。
手持件64具有观察构件(诸如翅片)66、顶部细长构件70和连接到并基本上平行于顶部细长构件的底部细长构件68。手持件也可以包括远侧夹紧部分72。手持件64的全部或部分可以涂覆弹性体材料和/或可以设置有凹槽、脊或有利于操作者牢牢抓握手持件64的表面构型。
观察翅片66在平行于针弯曲部65的平面的平面内从手持件延伸,从而即使在针主体62的远端在受试者体内且超出操作者的直接观察范围,也能够向操作者提供横向(针主体62的远侧部分在此方向推进)的视觉指示。另外,竖直观察翅片66的顶部边缘67平行于且基本上对齐针主体62的远侧部分,从而即使在针主体62的远端在受试者体内且超出操作者的直接观察范围,也能够向操作者提供竖直倾斜或针尖63的推进轨线的视觉指示。
图6示出设置在鼻窦针主体62上的针护套40。如图所示,针护套40的长度为使得当护套40被完全推进到针主体62上时,位于护套40的近端PE处的喇叭形区域46将紧靠手持件64的远侧表面,并且针主体62的远侧顶端63将伸出护套40的远端DE以外。如图所示,护套40为足够柔性的护套,以适形于鼻窦针主体62的弯曲部65。如图6所示,对于一些应用,可以任选地将光学或电图像导向元件74(如传感器、反射器、光源等)连接到手持件64的顶部细长构件70,从而允许根据耳鼻喉外科领域熟知的技术使用光学或电磁图像导向系统,以确定和/或导向针尖63在受试人或受试动物体内的定位。
美国专利No.5,314,417(名称为“安全套管针”)和美国专利No.5,267,965(名称为“安全套管针”)公开了可以任选地与鼻窦针装置60和护套40联合使用的安全机构,这两份专利的整个公开内容以引用方式并入本文中。
作为对具有诸如套管针尖63的锋利顶端的针主体63的替代形式,鼻窦针可以具有能够形成穿过预期组织(如就筛骨应用而言,穿过粘膜组织和骨骼)的所需穿透的任何其他合适的组织穿透装置。这些其他合适的组织穿透装置包括(但不限于)旋转钻、锉、双极或单极射频或电烙探针、激光探针等。图5D和图5E示出供选择的鼻窦穿透器60a的一个实例,该穿透器在构造上类似于上述鼻窦针60,不同的是,手持件的底部细长构件68替换成具有设置在其中的电机(未示出)和开关按钮的外壳68a。另外,在该装置中,针主体62替换成旋转锉组件,该组件具有细长的弯曲管62a,该弯曲管具有延伸穿过其中的柔性旋转驱动轴84和连接到驱动轴84远端的旋转锉顶端82,如图5E所示。由于驱动轴84为柔性轴,所以它即使在延伸穿过管状主体62a的弯曲部65a时也能够旋转。旋转锉顶端可以是0.6mm、0.7mm或0.8mm的金刚石锉顶端,并且电机、驱动轴84和锉顶端82可以与UltraburTM Fixed Tip Drill(UltraburTM固定顶端钻)(Invotec International,Inc.(Jacksonville,Florida))中使用的基本上相同。
在将针62替换成激光探针的其他可供选择的实施例中,光纤激光波导管可以延伸穿过探针,并且可以让合适类型的激光穿过波导管递送到探针的远端以外,以穿透所需的解剖结构。用于穿透筛泡或其他软组织或骨质鼻旁结构的一种合适类型的激光为钬激光。参见Metson,Ralph;Holmium:YAG Laser Endoscopic Sinus Surgery:A Randomized,ControlledStudy;Laryngoscope;106(1)Supplement 77:1-18(January 1996)(Metson,Ralph,“钬激光内窥镜鼻窦手术:随机对照研究”,《喉镜》,第106卷(第1期)增刊77:第1-18页(1996年1月))。
通过针筛窦切开术和植入持续皮质类固醇递送的物质递送垫片装置治
疗筛窦炎
图7A-7K示出一种方法的一个实例,利用该方法可以使用上述鼻窦针装置60、护套40和物质递送装置10进行针筛窦切开术,以有效“支架”筛窦切开术通道并在术后一段时间内将治疗性物质(如皮质类固醇)递送到患病的筛窦中。
如图7A所示,首先将针护套40置于如图6所示的针主体62上。在该实施例中,近侧护套部分42的内径足够大,以允许物质递送装置的约束护套30(如图1D和图1E所示)穿过其中,而远侧护套部分44的内径为等于或小于活动护套30的外径,但直径仍然为足够大,以允许收缩的贮存器14和未调配的保持翼18穿过进入其中。
将受试者麻醉或向其施用适当的止痛剂/镇静剂。如图7A所示,将其上安装有护套40的针主体62连同内窥镜400(诸如具有Storz Xenon300TM或Xenon NovaTM光源(Karl Storz GmbH & Co.(Tuttlingen,Germany))的Storz HopkinsTM II代0度耐高压加热的4mm×18mm望远镜)一起穿过受试者鼻孔。另外,在该实例中,C型臂荧光镜系统可以任选地用来在手术的部分期间提供荧光图像。适于此目的的市售C型臂荧光镜系统的一个实例是OEC 9800 PlusTM Digital Mobile Imaging System(OEC 9800 PlusTM数字移动成像系统)(G.E.OEC Medical Systems,Inc.(Salt Lake City,Utah))。操作者可以通过查看观察翅片66及其前缘67来验证针主体62的远侧部分处于正确的竖直倾斜和侧向上。在内窥镜的导向下,针尖50被穿过筛泡EB推入一个或多个筛骨气房EAC中。在鼻窦针主体62的该实施例中形成的大约33度的角度65允许在基本上平行于(或在一些情况下甚至偏离)相邻颅底SB的轨线上推进远侧顶端63。就这一点而言,当在成人身上进行手术时,筛窦切开术针主体62的弯曲部65的半径可以为约0.75英寸,并且可以形成约33度的角度A。针主体62的远侧部分(即从弯曲部62延伸至其远侧顶端63的部分)的长度为约24mm,从而允许方便地操纵针/护套组件,并允许在内窥镜400位于针/护套组件上方或下方的情况下将该组件沿着内窥镜400侧插入。筛窦切开术针主体62由直径为0.073英寸的304不锈钢线材形成,该不锈钢线材的测量拉伸强度(ASTMA313-03)在约253852psi至258665psi的范围内。当图像导向元件74连接到鼻窦针装置60的手持件64时,操作者可以另外使用用于光学或电磁图像导向的已知的技术和装置将鼻窦针主体62相对于颅底SB和其他重要解剖结构推进。另外,必须小心控制穿透深度,以便避免一直穿透蝶骨壁进入蝶窦SS中。为确保不攻破蝶骨壁,外科医生可以选择护套40,其中从护套40的远端DE到视觉标记物48的近侧边缘的距离为小于从筛泡EB的前表面到蝶窦SS的壁的距离。然后,可以通过内窥镜观察护套40上的远侧视觉标记物48,以测量进入筛骨气房中的穿透深度。当看到视觉标记物48的近端与筛泡EB齐平时,可以停止推进,从而确保没有攻破蝶骨壁。另外,如果护套40组装了可选的翼构件53,则该装置可以推进到这些翼构件53紧靠筛泡EB的前表面为止。另外,如图18所示,可以通过任何合适方式(诸如夹子602、抓紧器、粘合剂、摩擦接合或任何其他方式)将可选的外部止动构件600在引起止动构件600紧靠受试者鼻部的位置处连接到护套40,从而抑制针62和护套40被推进超过安全距离并进入筛骨中。介于近侧射线照相标记物52和远侧射线照相标记物56之间的距离为与贮存器14的长度基本上相同,并且可以通过荧光检查看到此类标记物44。外科医生可使用荧光图像来定位标记物52、56,使得这些标记物限定贮存器14的近端和远端将要驻留的位置。
如图7B所示,在护套40已被设置在所需位置中之后,撤出针49,从而将护套40留在适当的位置,使得护套40的近端延伸超出受试者鼻孔。
在插入物质递送垫片装置10之前,医生可以任选地回缩约束护套30以暴露缝线套环20,并且可以将具有直针或弯针19的一段2-O或3-O缝线材料17穿过缝线套环并对折。然后,可以将约束护套30移动至其推进位置,并且对折缝线17的相对两端将因此而伸出约束护套30的近端以外,如图7C所示。然后,将贮存器处于收缩状态并且约束护套30处于推进位置(如图2E所示)的物质递送装置10插入针护套40的近端中,如图7C所示。
接着,如图7D所示,将约束护套30处于推进位置的物质递送装置10穿过护套40推进到某个位置,在该位置处,由于约束护套30的远端邻接锥形段54内表面缩窄的壁而感受到进一步推进略有阻力。
随后,如图7E所示,外科医生将施加足够的力以克服推进阻力,从而导致当包括收缩贮存器14在内的物质递送垫片装置10的远侧部分推进到远侧护套部分42中时,约束护套30向近侧移动至其回缩位置(如图2D所示)。然后,通过观察装置10上的射线照相标记物24相对于远侧护套部分42上的射线照相标记物44的位置,可以通过荧光检查方式验证贮存器14在远侧护套部分42内的定位。另外,利用这些标记物可以检查贮存器14相对于围绕的解剖结构的实际定位。
然后,如图7F所示,可以向近侧撤出内部包含有约束护套30的护套40。这允许保持翼18向外弹出并接合筛骨气房EAC之间的相邻中隔壁,或作为另外一种选择接合筛泡EB的内壁表面。保持翼18的部署和接合可以通过荧光检查方式验证。这也允许缝线套环20暴露在邻近筛泡EB的鼻腔内。由于缝线套环的着色不同于血液和围绕的粘膜,所以缝线套环的暴露也可以通过荧光检查方式验证。
然后,如图7G所示,将包含0.31cc至0.35cc曲安奈德可注射悬浮液(Kenalog40,Brystol-Myers Squibb公司(Princeton,New Jersey))的注射器连接到物质递送垫片装置10的近侧鲁尔连接器16并注射曲安奈德可注射悬浮液,从而导致贮存器14扩张。在一些实施例中,物质递送垫片装置10的轴12可以是透明的,使得可以透过内窥镜400观察物质经中央腔13的递送。
接着,如图7H所示,切割与近侧鲁尔连接器16相邻的轴12,从而移除鲁尔套节16。这允许移除内部容纳约束护套30的鼻窦针护套42,从而释放缝线17和针19,以用于缝合到与缝线套环20相邻的解剖结构。作为另外一种选择,在一些实施例中,护套40可以设置有纵向穿孔或薄弱区域,这将允许剥落和移除护套。
如图7I所示,内部容纳约束护套的鼻窦针护套40被移除,并且利用缝线17将缝线套环20连接到相邻组织,诸如鼻中隔的粘膜M或覆盖筛泡EB的鼻腔表面的组织。
然后,如图7J所示,轴12在间距标记物15处或其远侧被切割,并且近侧轴12a被移除。
如图7K所示,该手术产生延伸到一个或多个筛骨气房EAC中的筛窦切开术通道或开口,其中物质洗脱贮存器14和远侧轴12b在进行针筛窦切开术之后一段时间(如在介于1小时至90天之间,优选地在介于7天至29天之间,最优选地为约14天,并且在一些情况下为约7天)内保留在位。另外,少量物质将留在其被切割位置处的远侧的远侧轴12b中。该留下的物质可以缓慢漏出远侧轴12b的切割端,从而为相邻鼻甲骨或鼻窦内的其他邻近解剖结构提供药物。
在该筛骨实例中,鼻窦针护套40具有由尼龙制成的远侧轴部分44,该远侧轴部分的外径为0.087英寸、内径为0.075英寸、长度为25mm。中间锥形区域54的长度为约5mm,并且从外径为0.104英寸、内径为0.088英寸的近端处渐缩至外径为0.092英寸、内径为0.075英寸的远端处。近侧轴部分42由尼龙12制成,并且其外径为0.102英寸、内径为0.088英寸、长度为3.5英寸。远侧护套标记物和近侧护套标记物44由外径为0.087英寸、内径为0.085英寸的铂-铱合金环制成。远侧轴标记物44位于距针护套134的远端DE 1mm处。近侧轴标记物148位于距针护套40的远端18mm处。针护套40的总长度为115mm。
虽然图7A-7K的实例为针对筛窦疾病的治疗,但图3A-3L的实例中所示装置的系统也可以用来在多种鼻旁窦和其他解剖结构中形成穿透通道或开口(如窦造口等),并用来将物质递送垫片装置10定位在此类穿透通道或开口内。另外,物质递送垫片装置10可以在身体的多种窦口、开口、切口和通道中与鼻窦针装置60分开使用,以只是充当垫片和/或递送所需的诊断或治疗性物质。在治疗鼻窦疾病的过程中,使用装置10将诸如Kenalog-40(曲安奈德可注射悬浮液,USP)的类固醇递送到鼻旁区域(诸如筛窦)。
可植入的装置10可用来优选地递送表面张力低的流体或悬浮液。表面张力低的流体易于扩散到整个表面上。这尤其可用于在较大表面积上(尤其在诸如筛窦之类具有复杂3D几何形状的解剖区域中)递送物质。在一个实施例中,表面张力低的流体包含表面活性剂。在一个方法实施例中,将含有一种或多种物质的表面张力低的灌洗液递送到筛窦。在一些实施例中,可以递送基本上惰性的流体(诸如盐水溶液)以润湿围绕的组织,并且该装置可以执行间隔和/或引流/通气功能。在其他实施例中,植入装置10除具有间隔和/或引流/通气功能之外,还可以递送诸如治疗或诊断物质的活性物质。
在一些应用中,可以将物质递送垫片装置10植入鼻旁窦的开口(如自然口、经外科手术改变的窦口、其他人造开口)内,以有利于治疗影响鼻旁窦的疾病或紊乱。在此类应用中,鼻旁窦的开口可以在将本发明的装置10、104设置在此类开口内之前或之后扩大(如扩张)。一种这类手术为鼻窦腔口球囊扩张术。在这种手术中,将具有基本上固定形状的导向导管插入穿过鼻部并推进到导向导管远端邻近鼻旁窦口的位置。然后将导丝推进穿过导向导管(如RelievaTM导向导管,Acclarent,Inc.(Menlo Park,California))并进入鼻旁窦中。然后,将球囊导管(如RelievaTM球囊导管,Acclarent,Inc.(Menlo Park,California))从导丝上方推进并用来扩张鼻旁窦口,从而改善从该鼻旁窦的引流和/或通气。此类鼻旁窦口球囊扩张装置和手术的实例在以下美国专利申请中有所描述:No.10/829,917,名称为“Devices,Systems and Methods for Diagnosing and Treating Sinusitis andOther Disorders of the Ears,Nose and/or Throat”(用于诊断和治疗鼻窦炎和耳鼻和/或喉部其他疾病的装置、系统和方法);No.10/944,270,名称为“Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinusesand Other Intranasal or Paranasal Structures”(用于扩张和改进鼻旁窦口和其他鼻内结构或鼻旁结构的装置和方法);No.11/116,118,名称为“Methods and Devices for Performing Procedures Within the Ear,Nose,Throatand Paranasal Sinuses”(用于在耳鼻喉和鼻旁窦内进行手术的方法和装置);No.11/150,847,名称为“Devices,Systems And Methods Useable ForTreating Sinusitus”(可用于治疗鼻窦炎的装置、系统和方法);和No.11/234,395,名称为“Devices and Methods for Delivering TherapeuticSubstances for the Treatment of Sinusitis and Other Disorders”(用于递送治疗性物质以治疗鼻窦炎和其他疾病的装置和方法),每一份该专利申请的整个公开内容均明确地以引用方式并入本文中。
通过球囊扩张额窦流出道和植入持续皮质类固醇递送的垫片装置来治
疗额窦炎
图8A至图8G示出可以在球囊扩张额窦流出道FSO之后将物质递送垫片装置10放入额窦流出道FSO中以执行支撑和物质递送功能的一种方法的实例。
在该手术中,插入内窥镜400,并且也可以任选地设置C形臂荧光镜(未示出),从而在需要时得到手术的荧光图像。虽然为了清楚和视觉上简单起见仅在图8A和8B中示出内窥镜400,但此类内窥镜400可以在该手术的整个过程或任何部分中留在适当的位置,并且可以用来实时观察装置的移动和操作,如该实例中所述。
在内窥镜的可视化下,将额窦导向导管500(如Relieva70 DegreeSinus Guide Catheter(Relieva70度窦导向导管),Acclarent,Inc.(MenloPark,California))插入穿过鼻孔并推进到其远端在额窦口FSO内或与该额窦口对齐的位置。导向导管500的这种定位可以通过内窥镜可视化和/或荧光检查验证。
然后,将导丝GW(RelievaSinus Guidewire(Relieva窦导丝),Acclarent,Inc.(Menlo Park,California))穿过导向导管500推入额窦FS中,如图8A所示。荧光镜404可以用来验证导丝GW已在额窦FS内卷起。
然后,如图8B所示,将扩张导管502(如Relieva或Relieva XLSinus Balloon Catheter(Relieva或Relieva XL窦球囊导管),Acclarent,Inc.(Menlo Park,California))在导丝GW上方推进并穿过导向导管500到其扩张器球囊504定位在额窦口FSO内的位置。荧光镜400可以用来验证导丝GW已在额窦FS内卷起。当扩张器504这样定位时,扩张器球囊504扩张,以引起额窦口FSO或其他额窦流出道扩张。该手术在共同待审的美国专利申请序列号11/355,512中有详细描述,该专利申请的整个公开内容明确地以引用方式并入本文中。在扩张结束之后,扩张器球囊504再次收缩,移除扩张导管502,从而让导丝504留在适当的位置。虽然该实例包括扩张额窦口FSO的这个步骤,但该扩张步骤是任选步骤。在一些患者中,窦口可能已经在此前手术中被扩张或改变,或医生可以确定在引入垫片装置10之前不需要扩张窦口。
然后,制备物质递送垫片装置10,并将其穿过导向导管500推入额窦FS中。在将装置10插入导向导管500中之前,可以移除约束管42,并且当把垫片装置10插入导向导管500的近端中时可以利用手指压力手动向前(即沿远侧方向)折叠保持翼18。当垫片装置的远端出现在导向导管500的远端之外时,保持翼18将向外弹起并接合额窦口FSO,如图8C所示。可以通过荧光检查方式验证贮存器14被定位在额窦内,并验证保持翼18已成功调配。
然后,如图8D所示,将包含0.31cc至0.35cc曲安奈德可注射悬浮液(Kenalog40,Brystol-Myers Squibb公司(Princeton,New Jersey))的注射器连接到窦垫片装置10的近侧鲁尔连接器并注射曲安奈德可注射悬浮液,从而导致贮存器14扩张。可以通过CT验证贮存器14a是否成功扩张。
然后,如图8E和图8F所示,切掉窦垫片装置10的近端并将导向导管向近侧回缩和移除。当移除导向导管时,操作者可以抓住远离导向导管500远端的垫片装置的轴12,以稳定垫片装置10并抑制其在移除导向导管500的过程中无意中移离额窦FS。
接着,可以切掉垫片装置10的轴12的近侧部分,从而让一短截轴12悬垂在鼻部内。使用具有直针19的缝线17将垫片装置10的缝线拉片20缝合到鼻部内的组织上,从而有助于在术后所需时间内将垫片装置10的植入部分保持在所需位置中。该物质中的一些将留在远离切割处的轴12的留下的段内,并且可以在术后渗漏到鼻腔中,从而也为鼻腔内的其他结构提供药物。
通过植入持续皮质类固醇递送的垫片装置来治疗额窦类
在该实例中,图9A-9D示出为成人受试者治疗额窦炎的另一种方法的步骤。额窦口FSO可能已经或尚未在此前通过上述手术进行了改变或扩张。在内窥镜的可视化下,将额窦导向导管500(如Relieva70 DegreeSinus Guide Catheter(Relieva70度窦导向导管),Acclarent,Inc.(MenloPark,California))插入穿过鼻孔并推进到其远端在额窦口FSO内或与该额窦口对齐的位置。导向导管500的这种定位可以通过内窥镜可视化和/或荧光检查验证。
然后,将导丝GW(RelievaSinus Guidewire(Relieva窦导丝),Acclarent,Inc.(Menlo Park,California))穿过导向导管500推入额窦FS中,如图9A所示。荧光镜404可以用来验证导丝GW已在额窦FS内卷起。
结合图9B,在导丝GW已被插入额窦中之后,移除额窦导向导管500,从而让导丝GW留在适当的位置。5F血管扩张器420(如5F血管扩张器(内径为0.038英寸),Merritt Medical Systems,Inc.(South Jordan,UT))。然后,在导丝GW上方推进护套/扩张器组合。可以利用C型臂荧光镜和/或内窥镜400观察护套/扩张器组合推进到护套40的近侧射线照相标记物52远离额隐窝的位置(即在额窦腔内)的情况。一旦窦护套40在保留在扩张器的中央腔内的同时被推进到该位置,就移除5F扩张器420和导丝GW,从而让护套40留在适当的位置,如图9C所示。
然后,按上述方式制备物质垫片装置10,并将约束管30设置在其推进位置中,以便约束并覆盖缝线套环20、保持翼18和贮存器14在其收缩位置中。采用与上文所述并在图8C-8E所示基本上相同的方式将装置10推入此前插入的护套40中。
然后,收回护套40和约束管30,并如此前所述将包含0.31cc至0.35cc曲安奈德可注射悬浮液(Kenalog40,Brystol-Myers Squibb公司(Princeton,New Jersey))的注射器连接到窦垫片装置10的近侧鲁尔连接器并注射曲安奈德可注射悬浮液,从而导致贮存器14在额窦FS内扩张。如果需要,可以通过CT验证贮存器14a是否成功扩张。
然后,切掉窦垫片装置10的近端,并采用与上文所述并在图8H-8I所示相同的方式向近侧收回并移除护套40和约束管30。
接着,可以切掉垫片装置10的轴12的近侧部分,从而让一短截轴12悬垂在鼻部内。使用具有直针19的缝线17将垫片装置10的缝线拉片20缝合到鼻部内的组织上,从而有助于在术后所需时间内将垫片装置10的植入部分保持在所需位置中,如图9D所示。如上所述,留在远离切割处的一短截轴12内的曲安奈德悬浮液可以随后渗漏到鼻腔NC中,从而向该区域中的组织提供一些附加的治疗有益效果。
额窦炎治疗的替代方法
图10A示出被构造用于向额鼻旁窦递送物质的物质递送系统500的实施例。在一个实施例中,系统500可以包括物质递送装置510,该物质递送装置510包括窦垫片511、用于在递送过程之前和一部分中覆盖窦垫片511的护套530,以及将窦垫片511穿过其中导向到额窦中的导向装置540。下文将更详细地描述这些装置中的每一个。在一些实施例中,系统500也可以包括注射器(未示出)或其他物质/流体注射装置,该装置用于连接到物质递送装置510的近端并将物质/流体穿过装置510注射到窦垫片511中。一些实施例还可以包括在注射器中的一定量预填充物质,包括(但不限于)本文所列物质中的任何物质。任选地,一些实施例也可以包括柄部(未示出),该柄部用于连接到导向装置540,以有利于抓握导向装置540并将其推入患者鼻孔中。在可供选择的实施例中,可以使用任何合适的柄部,例如,在一个实施例中可以使用Relieva SidekickTM SinusGuide Catheter Handle(Relieva SidekickTM窦导向导管柄部)(Acclarent,Inc.(Menlo Park,California))。
图10B至图10E更详细地示出图10A所示物质递送装置510和可植入的窦垫片511。装置510包括具有近侧部分512a和远侧部分512b的细长柔性导管轴512,其中远侧部分512b被视为窦垫片511的部分。与此前所述实施例相同,近侧部分512a和远侧部分512b可以诸如通过切割在接合部515处或其附近彼此切断。在所示实施例中,近侧轴部分512a为不透明的,而远侧轴部分512b为相对半透明或透明的,使得在手术过程中可以用内窥镜观察接合部515。此外,近侧轴部分512a和远侧轴部分512b可以由相同或不同材料形成,并且可以具有相同或不同尺寸(如直径、壁厚等)。例如,一种此类材料为聚酰胺。在一些实施例中,远侧轴部分512b可以由更柔韧的生物相容性材料诸如尼龙或聚对苯二甲酸乙二醇酯(PET)制成。中央腔连续地延伸穿过轴512。此外,远侧轴部分512a可以渐缩或颈缩成直径比近侧轴部分小,以有利于装置的插入。可以在中央腔的远端中安装塞子。塞子可以具有任何合适的闭合构件,诸如管上封闭端的壁、端盖、中央腔末端内的团块或任何其他合适的阻流构件。
窦垫片511通常包括远侧轴部分512b、安装在远侧轴部分512b上并靠近其远端的可扩张式贮存器514、用于将窦垫片511保持在鼻窦内的可伸缩的保持构件518、和缝线套环517,从而允许医生可选地将窦垫片511连接到粘膜组织,以进一步确保窦垫片511停留在所需的植入位置中。通常,窦垫片511可以具有任何合适的尺寸、特征、贮存器洞/小孔数量、以及保持构件518的尺寸、形状和数量等等。这些特征和细节中的许多者已在上文中描述,因此此处不再重复。介于额窦垫片511和上述用于筛窦的垫片之间的若干区别如下。在扩张构型下从顶端至顶端测量的保持构件518的翼展对于额窦垫片装置511为大约13-16mm,而对于筛窦垫片则为大约9-12mm。每一个保持构件518在其扩张构型下相对于轴512的角度为约70度,而在筛窦垫片中则为约80度。另外,额窦垫片511的总长度(即透明的远侧轴部分512b)为大约65mm+/-3mm,而在筛窦垫片中则为大约50mm+/-3mm。当然,这些特征仅描述了额窦垫片511的一个实施例,各种可供选择的实施例可以具有不同的尺寸。
贮存器514在被填充时呈现出扩张构型。此处,贮存器514可以由任何合适的生物相容性材料形成,并且在一些实施例中可以包括由非适形或半适形材料诸如尼龙12形成的球囊。贮存器可包括多个开口,并可被构造成如图2A和图2B所示情形。此外,如前所述,优选的是贮存器的材料和壁厚为使得贮存器为足够柔性的,以:a)允许在不导致明显创伤的情况下将装置从身体抽出和移除;b)不迫使贮存器的所有内容物立刻流出;并且c)使在其中形成的开口531[John-我在图中没看到531标记。]在贮存器扩张时保持基本上一致的尺寸。
如下所述,贮存器514可以在收缩构型下插入额窦口或流出道中,然后可以将贮存器填充所需物质,从而导致贮存器过渡到扩张状态。
在一些实施例中,不需要将贮存器514用来递送治疗性物质。事实上,该贮存器可以用作占位装置。在这类应用中,贮存器514可以就地填充盐水溶液或其他惰性液体,从而导致贮存器514扩张并摩擦接合或接触相邻的解剖结构,从而在所需植入位置处提供一定程度的保持。可以通过在贮存器上设置表面凸起来进一步促进贮存器514的这个方面。
贮存器514在处于其收缩构型时的直径可以为相对较小,从而允许将其容易地引入或移除。在贮存器514由非适形或半适形材料形成的实施例中,贮存器514在填充过程中将不会发生较大的弹性变形,因而不会对其内容物施加用于通过开口531排出所需物质的压力。相反,贮存器514中的物质将通过重力和/或粘液因纤毛作用穿过窦而穿过开口531洗脱。这种非加压递送允许在数日内缓慢释放所需物质。在一些其他实施例中,贮存器514可以由具有小开口531的适形或弹性材料形成,使得当物质递送到开口531以外时形成球囊514的材料将收缩,从而维持球囊内的压力。另外,在该实例中,如图所示,贮存器具有限定贮存器工作长度的圆柱形侧壁514a、从圆柱形侧壁514a过渡到远侧轴512b(贮存器远侧)的远侧锥形物514b和从圆柱形侧壁514a过渡到远侧轴512b(贮存器近侧)的近侧锥形物514c、和延伸到近侧锥形物514c和远侧锥形物514b上的开口531。贮存器514可以具有如此前结合其他实施例所述的尺寸、开口和整体构型。
在一个实施例中,远侧轴部分512b可以由尼龙12制成。如上所述,在一个实施例中,窦垫片511从远侧顶端至远侧轴部分512b近端的全长可以为约65mm+/-3mm。在导管轴512中形成小孔,以有利于填充贮存器514。也可提供阀门以允许物质(或物质的组分)从导管轴12的中央腔流入贮存器514内,并抑制从贮存器514大量回流到中央腔513中。阀门可以包括任何合适类型的单向阀。
另外,可以提供远侧射线不可透的标记物524和近侧射线不可透的标记物522,以有利于贮存器514在受试者体内的所需定位。这些标记物522、524中的每一个都可以由射线不可透材料的环制成,并且可以与贮存器的圆柱形侧壁514a的每一个末端都对齐地安装在轴512上。例如,每一个标记物522、524都可具体化为铂-铱合金带。这些标记物在包括荧光检查和CT扫描在内的多种成像技术下可见。
在一个实施例中,近侧轴部分512a可以由聚酰亚胺管材制成。包括由透明聚碳酸酯制成的内螺纹鲁尔连接器的套节516可连接到轴512的近端。近侧轴部分512a和远侧轴部分512b通常可以具有结合上述其他实施例所述的类似导管轴的尺寸、特征、材料等中的任何一个。在一个实施例中,近侧轴部分512a可以包括轴标记物513。轴标记物513可以沿着轴512设置,使得在推进过程中当轴标记物513的远端到达护套530上止动构件531的近端时(下文中有更详细的描述),窦垫片511的远端与导向装置540的远端相邻。当轴标记物513的近端到达止动构件531的近端时,窦垫片511已推进超出导向装置540的远端。下文结合图13A-13H对窦垫片设置手术过程中轴标记物的用途进行了更为全面的描述。
另外,可植入的物质递送装置或垫片510还可包括一对保持翼518。应当认识到,作为另外一种选择,垫片510可包括三个或四个或更多个此类翼。保持翼518设置在轴512上完全相对的位置处,并且从贮存器514周围向远侧延伸。每一个保持翼518都可具体化为预成形的镍-钛(镍钛诺)线材套环。每一个保持翼518都可以弯曲或压缩至收缩位置,在该位置处保持翼基本平坦地靠着贮存器514的外表面。然而,保持翼518被偏置为预成形构型,使得当不受拘束时,每一个保持翼518都将有回弹力地向外弹向伸长位置,其中保持翼以相对于轴512的纵向轴线成约20度至约90度的角度延伸,并且更理想的是成约50度至约80度的角度延伸,并且在一个实施例中成约70度的角度延伸。在多种实施例中,翼518可以限定的翼展为约9mm至约20mm或更大,更理想的是从约13mm至约16mm,并且在一个实施例中为约15mm。在一个实施例中,垫片装置511的远端可以设置有由软质聚合物形成的无创伤顶端。此外,在一些实施例中,可以选择翼518的几何形状和位置,以使得封装在贮存器514中的药物能够从邻近和远离翼518的开口531两者洗脱出来。在可供选择的实施例中,翼518可以沿着轴512设置,使得所有开口531均设置在翼518远侧。
如图10D和图10E所示,管状约束护套530[图中标记为30,而非530。]可以设置在可植入的物质递送装置510的轴512的上方。例如,在一个实施例中,可以将该约束护套530构造为长度为约75mm+/-2mm(但在可供选择的实施例中可以使用其他长度)的塑性管材。该约束护套530在回缩位置(图10D所示)和伸长位置(图10E所示)之间为可来回移动的护套。当在伸长位置中时,约束护套在保持翼518和收缩的贮存器514上方延伸,从而将保持翼518保持在其收缩位置中,并形成平滑的保护性覆盖物。当在伸长位置中时,约束护套530会增强整个装置510的裂断强度,并且会将轴512在被推动穿过相对狭窄和/或曲折的解剖通道时的扭折减小到最低程度。在装置510已被插入到所需位置后,可以将约束护套512撤回到其回缩位置,从而允许保持翼518向外回弹至其伸长位置,并允许贮存器514在随后填充所需物质时发生扩张。
在一个实施例中,护套530包括近侧止动构件531。止动构件531被配置成当护套530和物质递送装置510被推进到导向装置540中时邻接导向装置540上的近侧鲁尔连接器。因此,在推进护套530和物质递送装置510时,止动构件531将阻止护套530的推进,而物质递送装置510继续被推进,以使得窦垫片退出导向装置540的远端。换句话讲,具有止动构件531的护套530允许窦垫片511的翼518在推进到患者体内之前和推进过程中受到约束,直到垫片511被推进超出导向装置540的远端。
护套530也可以包括倾斜或斜切的远侧顶端532。该倾斜的远侧顶端532形状可以有利于在手术过程中于必要时将窦垫片511拉回护套530中。远侧顶端532也可以有利于护套530穿过导向装置540推进。
可植入的物质递送装置的其他可供选择的实施例示于图11A-11D中。在一个方法中,如图11A所示,可植入的装置510可包括一对保持翼521、523,该翼形成套环并设置在沿装置的交错位置处。例如,一个翼521可连接到邻近介于贮存器514和轴512之间接合部的装置第一侧面,而第二翼523可连接到邻近第一翼518的轴512。在这样的翼布置中,底翼523可以推挤额隐窝壁(通向并恰好邻近额窦的通道),从而有助于将顶翼521维持在额窦内的所需位置。在另一个方法中(参见图11B),翼521、523可类似地交错排列,但能够从可植入的物质递送装置510的同一侧伸出。在又一个方法中(参见图11C和图11D),除包括可沿贮存器514周边延伸的完全相对的翼518外,可植入的装置510还可包括具有各种构型的底翼525,诸如形成整体L形(图11D)或S形(图11C)的构型。底翼525还可具有适于停留在额隐窝上和用于横向地推动装置轴512的强度和几何形状。多个偏置翼也有利于增强物质递送装置510在额隐窝/额窦解剖结构中的锚固性。
现在转到图12A-D,其中示出护套或导向装置540的多种实施例。导向装置540被配置成用于将可植入的装置(诸如上述那些)推进到额隐窝和/或额鼻旁窦中,如(例如)图13A-13E所示。通常,导向装置540可以包括近侧直部542、具有射线不可透的远侧顶端545的远侧曲部544、和近侧鲁尔连接器546。在一个实施例中,导向装置540可以由成形为管的聚合物制成,并且可以弯曲以形成远侧部分544,并在近侧部分542上方设置有直的海波管。在一个实施例中,弯曲的远侧部分544可以为相对柔性的部分,以使得其具有足够的穿过鼻腔推进的推送性能,但又有足够的柔韧性以抑制对鼻腔壁和结构造成损伤。可以将导向装置540的全长、曲率角和构型设计为以使得近侧鲁尔连接器546保持在患者鼻部的外部,而导向装置540穿过鼻孔和鼻腔延伸,使得远端545设置在额鼻旁窦口中或其附近。
在一些实施例中,护套或导向装置540可以具有能被调节以适应患者解剖结构的可成形(可弯曲、可延展等)远侧部分或顶端。顶端可以预成形为具有给定弯曲,但在必要时用户可以对其进行调节。此类顶端的材料可以是可弯曲或可延展的管材,该管材可以保持其形状,也可以根据需要反复成型。例如,在一个实施例中,该材料可以是一种塑料编织线527(参见图12B)或弹簧529(参见图12C)。此外,此类结构可被塑料封装(参见图12D-E),或此类结构可围绕塑料(图12B-C)。该材料也可以由可锻金属制成。因此,如果护套或导向装置的预成形顶端不适用,则可以重塑顶端,以便穿过额隐窝并引导到额窦中。
现在参见图13A-H,图中示出用于治疗额窦的另一种方法。为简明起见,该方法实施例未示出与导向装置540连接的柄部的用途,然而,在可供选择的实施例中,柄部(上述)可以在初始推进步骤之前与导向装置540连接。
在一些实施例中,物质递送装置510可以按上述进行制备,并且约束护套530可以设置在其推进位置中,以覆盖保持翼518和贮存器514,并将它们约束在收缩位置。在可供选择的实施例中,护套530和物质递送装置510可以具有随时可用的构型。
如图13A所示,在内窥镜的可视化下,将额窦导向导管540插入穿过鼻孔并推进到其远端邻近额窦口FSO、在额窦口内或与额窦口对齐的位置。导向装置540的这种定位可以通过内窥镜400可视化和/或通过荧光检查(例如,相对于额窦口观察导向装置的射线不可透的远侧顶端)进行验证。如此前所提及,因为额窦具有较长的流出道(额隐窝),所以期望将垫片装置510至少部分地定位在流出道内可为可取的,并且可定位导向装置或护套540来实现此目的。
下一步,如图13B所示,可以将具有设置在窦垫片511上方的约束护套530的物质递送装置510推进到导向导管540中并穿过其推进。接着,如图13C所示,将物质递送装置510和护套530进一步穿过导向装置540推进,直到护套上的止动构件531邻接导向装置540上的鲁尔连接器546。将物质递送装置510进一步穿过导向装置540和被阻止的护套530推进,直到轴标记物513的远端到达止动构件531的近端,从而指示窦垫片511的远端邻近导向装置540的远端。如图13D所示,在物质递送装置510进一步穿过导向装置540和被阻止的护套530推进的过程中,当轴标记物513的近端到达止动构件531的近端时,窦垫片511已推进超出导向装置540的远端,从而将保持翼518调配在额窦内。
此后,如图13E所示,穿过导管轴512将物质注入到窦垫片511的可扩张式贮存器514中,以扩张贮存器514并允许物质从贮存器514中的洞中洗脱出来。在一个实施例中,包含物质(例如皮质类固醇悬浮液,诸如(但不限于)曲安奈德、抗生素、抗真菌剂、非甾体抗炎剂和/或类似物质)的注射器连接到物质递送装置510的近侧鲁尔连接器516。然后注入可注射的组合物,从而导致贮存器514扩张。在一些实施例中,注入的物质和/或贮存器514可能是射线不可透的,以使得贮存器514a的成功扩张可以通过荧光检查或其他合适的射线照相技术验证。
接下来,如图13F所示,切掉或换句话讲移除物质递送装置510近端上的鲁尔连接器516。如图13G所示,接着导向装置540可以在物质递送装置510上方向近侧滑动,以从鼻孔移除导向装置540。如图13H所示,然后(诸如)通过将剪刀插入鼻孔中并在近侧部分512a和远侧部分512b的接合部处或其附近剪切,而将窦垫片装置511与近侧导管轴部分512a分离。然后可以将近侧轴部分512a从患者移除,从而让窦垫片511留在额窦内适当的位置并延伸到额窦流出道/额隐窝中。在一些实施例中,医生可能希望通过将缝线套环517的金属圈连接到鼻腔内的粘膜而进一步固定窦垫片511。然而,这并不是必要的步骤,并且保持翼518通常会将窦垫片511固定在额窦内。
窦垫片511可以含有任何合适的物质或物质组合,诸如(但不限于)本专利申请中所列物质中的任何物质。窦垫片511可以在额窦内停留任意时长,诸如从一天至一年,并且更理想的是从约7天至约90天,并且甚至更理想的是从约14天至约一个月。在一些实施例中,可以使用额窦垫片511仅将物质递送到额鼻旁窦。作为另外一种选择,可以将物质递送到额窦和额隐窝或流出道,并且在一些情况下,甚至可以递送到鼻腔内更为近侧。通常,选择的是递送的物质不仅在鼻窦内、还在鼻腔内其可被递送到的任何其他位置中产生有益效果。
就上述实施例而言,可以在使用Balloon SinuplastyTM窦扩张术扩张额窦口和/或额窦流出道后执行刚才所述的方法。作为另外一种选择,可以对“自然”、未开过刀的额鼻旁窦执行该方法。是否进行先前的BalloonSinuplastyTM窦扩张术,有时可能取决于额窦口和/或额窦流出道的宽度。
现在参见图14A-14D,示出植入额窦中的垫片装置510的可供选择的实施例。在一个可供选择的方法中,垫片510的膜或贮存器514具有相对较长的轮廓,使得其长度的一部分在额窦隐窝内向近侧延伸。另外,垫片装置510的实施例可包括不同定位的交错排列的保持翼521、523,如图14B和图14C所示,其中位于近侧的翼523与额窦隐窝并置,使得垫片装置510的所需取向得以实现。也可植入包括底翼525的垫片装置510,使得底翼525在介入位点处有助于垫片的固定和取向两者(参见图14D)。
虽然附图和上述实例已具体示出用于将物质递送垫片装置510植入额窦中的技术,但也可以使用类似技术将该装置植入其他鼻窦中。当然,可能需要多种其他方法和递送设备来完成该操作。
植入后垫片装置内曲安奈德的稳定性
进行了一项研究,以确认当将曲安奈德可注射悬浮液(Kenalog40,Brystol-Myers Squibb公司(Princeton,New Jersey))填充到物质递送垫片装置10的贮存器14中时,该可注射悬浮液可在植入装置后至少30天内保持药理活性的完整性和有效性。在此研究中,通过注入0.31cc上述曲安奈德可注射悬浮液来填充一个装置10的贮存器14(以下简称“填充了曲安奈德的贮存器”)。用生理盐水填充第二个装置10的贮存器14(以下简称“填充了安慰剂的贮存器”),并将第三个装置的贮存器保持空载(以下简称“空载贮存器”)。将所有三个装置放入Caron Model 6030Environmental Stability Chamber(Caron Model 6030环境稳定室)中并维持在ICH稳定性条件下(40℃±2℃/75%RH±5%RH)。在0天和30天时对每一个贮存器内容物的等分试样进行高效液相色谱(HPLC)分析。此研究的结果汇总于下表1中:
RRT=峰的RT/TA的RT(RRT=相对保持时间,RT=保持时间)
各个杂质%=(杂质峰面积/K-40窦垫片总峰面积)×100
K-40窦垫片在0天的总平均峰面积=5869075
K-40窦垫片在30天的总平均峰面积=5233043
总杂质%=(杂质总峰面积/K-40窦垫片总峰面积)×100
只有杂质峰≥0.02%的杂质才被视为显著杂质。
通过HPLC确定得自填充了曲安奈德的贮存器分别在0天和30天的样品的曲安奈德效价。在此研究中,杂质含量在可接受范围内升高,并且曲安奈德贮存器中存在的曲安奈德的效价足以引起至少30天的预期局部抗炎效应。
使用物质递送垫片装置10递送的曲安奈德的功效
使用局部皮质类固醇疗法治疗慢性鼻窦炎性病症是基于以下基本原理:局部疗法可在鼻粘膜内局部受体位点处达到更有效的药物浓度,其中全身副作用的风险最小。曲安奈德(TA)是第二代合成皮质类固醇,其中当前有六种化合物获批用于鼻内应用。所有六种皮质类固醇在效价和有效性方面看起来相对相等。选择TA用于筛窦垫片是因为该化合物具有最长的安全记录,并且其在适用于本装置的浓缩溶液中有效。具体地讲,使用Kenalog-40是因为它是被批准上市的曲安奈德制剂之一。
现已明确,曲安奈德鼻内给药和/或吸入剂量即使递送长达三年也不会引起下丘脑-垂体-肾上腺(HPA)抑制。参见:Klossek JM等人的LocalSafety Of Intranasal Triamcinolone Acetonide:Clinical And HistologicalAspects Of Nasal Mucosa In The Long-Term Treatment Of Perennial AllergicRhinitis,Rhinology,39(1):17-22(2001)(“曲安奈德鼻内给药的局部安全性:长期治疗常年性过敏性鼻炎过程中鼻粘膜的临床和组织学特征”,《鼻科学》,第39卷(第1期):第17-22页(2001年));Lund,VJ.的Maximal Medical Therapy for Chronic Rhinosinusitis,Otolaryngol Clin N Am38,1301-1310(2005)(“慢性鼻窦炎的最大剂量药物治疗”,《北美耳鼻喉科临床》,第38卷,第1301-1310页(2005年));和Laliberte F等人的Clinical And Pathologic Methods To Assess The Long-Term Safety Or NasalCorticosteroids,Allergy 55(8):718-722(2000)(“评估鼻用皮质类固醇长期安全性的临床和病理学方法”,《过敏学》,第55卷(第8期):第718-722页(2000年))。
现已证实,局部施用TA可降低早期和晚期两者过敏反应的严重程度、降低局部鼻腔刺激性受体的敏感性、减轻局部炎症,并降低鼻病毒续发性感染的可能性。即使长期向鼻窦局部递送TA看起来也不会损伤鼻粘膜。
用于该研究的物质递送垫片装置10中的载体容积具有填充到最大容量时可容纳0.1ml药物的贮存器14。如果用Kenalog-40填充到最大容量,贮存器将包含4mg的TA。这个量的TA与正常人体肾上腺每日产生的35-40mg皮质醇的效价大致等同。因此,即使全部4mg的TA一次全部释放,预计也不会对肾上腺类皮质激素活性产生不利影响。
如上所述,物质递送垫片装置10的贮存器14中的开口31可以被设计为限制TA从贮存器扩散,以使得在两周的时间内每日仅递送小剂量的药物。这样,局部递送到筛窦或其他鼻旁窦中的剂量可能为小于用市售鼻腔吸入器(如NasacortInhaler(Nasacort吸入器),Sanofi-Aventis(Bridgewater,New Jersey))递送的推荐TA剂量。
通过进行针筛窦切开术并通过植入基本上如上述和图7A至图8J所示的物质递送垫片装置10在术后递送TA,对十三名患有筛窦炎的受试人进行了治疗。这些受试者中的九名接受双侧治疗,其余四名接受单侧治疗。因此,总共治疗了二十二个筛窦。通过额窦流出道球囊扩张术并通过植入基本上如上述和图8A至图8G所示的物质递送垫片装置10在术后递送TA,对患有额窦炎的第十四名患者进行了治疗。
术后随访和数据收集
受试者No.1-10:
在施用麻醉药前、以及植入并填充物质递送垫片装置10后1小时、2小时和4小时测定受试者No.1-10的血液TA含量。如果特定受试者在治疗机构处住下过夜,则在23小时或即将出院前采集血样。在术后3天、7天、10天和14天以及外植和移除物质递送垫片装置10之前采集受试者No.1-10的附加的血样。
除了如上述采集血样外,还要求患者在基准日以及在外植和移除物质递送垫片装置10后1周、2周和6周填写Sino-Nasal Outcomes Test(SNOT-20)(鼻腔鼻窦结局测试)调查问卷(SNOT-20-Piccirillo,JF等人的Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test(SNOT-20),Copyright1996 by Jay F.Piccirillo M.D.,Washington University,St.Louis,Missouri)(“20条鼻腔鼻窦结局测试(SNOT-20)的心理测量和临床测量有效性”,版权所有(1996年),所有人为华盛顿大学(St.Louis,Missouri)的Jay F.Piccirillo M.D.)。另外,还要求患者填写针对物质递送垫片装置10的耐受性的调查问卷。在植入后14天的就诊中移除该装置。对装置中残余药物的定量提供了关于该装置植入过程中曲安奈德从筛窦垫片洗脱的附加的信息。
调查员根据需要提供术后护理,但不施用类固醇类鼻腔喷剂和鼻腔冲洗剂。调查员根据需要自行决定是否进行术后抗生素治疗。这是为了将合并用药对研究结果的影响降到最低。
八周后进行最终的筛窦CT扫描,以评估筛窦状况和与基准日相比的改善程度。
受试者No.11-13:
受试者No.11-13接受与受试者No.1-10相同的术后护理和血样采集,不同之处如下:
在施用麻醉药前采集基准日血样后,在手术当日植入装置后4小时抽取血样,并于1天、(任选地)3天、7天、14天、21天、28天、以及外植和移除物质递送垫片装置10之前抽取血样。
在整个研究期间安排了六次随访,分别是在术后3天、7天、14天、21天和28天的随访、以及术后10周的最终探访。除了如上述采集血样外,还要求患者在基准日和在外植后1周、2周和6周填写SNOT-20生活质量(QOL)调查问卷。另外,还要求患者填写针对筛窦垫片耐受性的调查问卷。在植入后28天的就诊中移除该装置。
调查员根据需要提供术后护理,但不施用类固醇类鼻腔喷剂。调查员根据需要自行决定是否进行术后抗生素治疗。这是为了将合并用药对研究结果的影响降到最低。
十周后(外植后六周)进行最终的筛窦CT扫描,以评估筛窦状况和与基准日相比的改善程度。
受试者No.14:
受试者No.14是接受额窦炎治疗的患者,而非筛窦疾病的患者。受试者No.14接受与受试者No.1-10方式基本上相同的术后随访和数据收集(如血样和SNOT-20调查问卷)。
CT扫描结果
读取CT扫描,并通过Lund McKay评分法对受影响的鼻窦的改善状况进行评分。这些Lund McKay评分以图表方式示于图15中。在基准日(术前),平均Lund McKay评分为10.4。在随访日,平均Lund McKay评分为3.9。因此,这14名受试者显示出Lund McKay评分平均下降65.1%。
SNOT-20和调查问卷结果
图16示出在1周、2周、4周和6周测定的SNOT-20评分与基准日相比的平均改进(注意:有一名患者偏离方案并在四周内完成了6周随访)。评分为1.07或更低时被视为鼻窦炎症状在临床意义上显著减轻的表征(即,与基准日SNOT 20评分相比减小至少0.8)。这些数据表明在术后2周、4周和6周观察到平均SNOT 20评分在临床意义上显著降低。
将症状改善状况也记载于术后1周、2周和6周开展的患者调查问卷中。所有患者均报告他们的症状在术后六周有显著改善或改善,没有患者报告病情加重。在六周时大多数患者对治疗效果满意,并表示如果让其再次选择是否进行该种治疗,他们会同意进行手术。
结果的统计学分析
在5次术后评估探访中记录了SNOT-20结果。根据该端值评估的原假设和备择假设如下所示:
Ho:μ(42天-基准日)=0
Ha:μ(42天-基准日)≠0
使用配对差异t检验对通过比较SNOT-20评分与基准日相比的变化而得到的单变量分析结果进行分析。该分析的结果显示术后7天内SNOT-20评分显著降低。在所有的术后连续评估探访中观察到评分一致降低。在结束入选时,14名患者中有13名(92.9%)已完成42天的术后评估探访。术后42天的SNOT-20规模与基准日相比减少了22.08分,标准偏差为14.69,概率值<0.001。该结果的效应量为1.50,这反映了非常强效的治疗效果。
Lund-McKay评分(CT扫描)
在基准日和术后42天进行CT扫描,获得LMK评分。根据该端值评估的原假设和备择假设如下所示:
Ho:μ(42天-基准日)=0
Ha:μ(42天-基准日)≠0
使用配对差异t检验对通过比较LMK评分与基准日相比的变化而得到的单变量分析结果进行分析。该分析的结果显示术后42天LMK评分显著降低。LMK规模与基准日相比减少了6.50分,标准偏差为3.96,概率值<0.001。该结果的效应量为1.64,这反映了非常强效的治疗效果。
通过比较筛窦LMK评分的变化进行子集分析。该分析的结果同样显示术后42天LMK评分显著降低。LMK规模与基准日相比减少了2.21分,标准偏差为1.53,概率值<0.001。该结果的效应量为1.44,这反映了非常强效的治疗效果。
采用推论统计学检查一次功效端值。根据入选的14名患者的成功表现(100%),95%精确二项式置信度区间的下限为76.84%。
血浆分析
为评估随着时间的推移TA从物质递送垫片装置10洗脱的能力的二次端值,测定了来自采集血样中的每一个的血浆中的TA浓度。这些数据汇总于下表2中。
表2
在不同时间点处的血浆/TA含量汇总(测量单位:pg/mL)
直到植入并填充物质递送垫片装置10后28天,在受试者的血浆中仍可测得TA,此时的TA含量很低(即,不具有全身活性),但仍可检测出来。
结论
TA的局部有效剂量在术后最多28天内从物质递送垫片装置10递送出来。CT扫描显示鼻窦炎显著减轻。根据SNOT 20和患者调查问卷结果,受试者也意识到鼻窦炎症状显著改善。
如本文所用,术语“物质”从广义上解释为包括任何可行的药物、前药、蛋白质、基因治疗制剂、细胞、诊断剂、造影剂或显像剂、生物制剂等。此类物质可以是结合或游离形式、液体或固体、胶体或其他悬浮液、溶液,或可以是气体或其他流体或非流体形式。例如,在一些需要治疗或预防微生物感染的应用中,递送的物质可以包括以下试剂的可药用的盐或剂型:抗微生物剂(如抗生素、抗病毒素、抗寄生物剂、抗真菌剂等)、皮质类固醇或其他抗炎剂(如NSAID)、减充血剂(如血管收缩剂)、减薄粘稠分泌物的药物(如祛痰剂或黏液溶解剂)、抑制或调节变应性反应的试剂(如抗组胺剂、细胞因子抑制剂、白三烯抑制剂、IgE抑制剂、免疫调节剂)、含有或不含血管收缩剂的麻醉剂(如含有或不含肾上腺素的利多卡因)、止痛药、过敏原或另一种导致组织分泌粘液的物质、阻止出血的止血剂、抗增殖剂、细胞毒素剂(如乙醇)、生物制剂(如蛋白质分子)、干细胞、基因或基因治疗制剂、携带蛋白质或核酸(如编码用于重要治疗功能或物质的DNA或mRNA)的病毒载体、烧灼剂(如硝酸银)等。
可以用于本发明的抗微生物剂的一些非限制性实例包括:阿昔洛韦、金刚烷胺、金刚烷乙胺、奥塞米韦、扎那米韦、氨基糖苷类(如阿米卡星、庆大霉素和妥布霉素)、阿莫西林、阿莫西林/克拉维酸盐、两性霉素B、氨苄青霉素、氨苄青霉素/舒巴坦、阿托伐醌、阿奇霉素、头孢唑啉、头孢吡肟、头孢噻肟、头孢替坦、头孢泊肟、头孢他啶、头孢唑肟、头孢曲松、头孢呋辛、头孢呋辛酯、头孢氨苄、氯霉素、克霉唑、环丙沙星、克拉霉素、克林霉素、氨苯砜、双氯青霉素、强力霉素、红霉素、氟康唑、膦甲酸、更昔洛韦、加替沙星、亚胺培南/西司他丁、异烟肼、伊曲康唑、酮康唑、甲硝唑、萘夫西林、制霉菌素、青霉素(包括青霉素G)、喷他脒、哌拉西林/他唑巴坦、利福平、奎奴普丁-达福普丁、替卡西林/克拉维酸盐、三甲氧苄二氨嘧啶/磺胺甲噁唑、伐昔洛韦、万古霉素、磺胺米隆、磺胺嘧啶银、莫匹罗星、制霉菌素、曲安西龙/制霉菌素、克霉唑/倍他米松、克霉唑、酮康唑、布康唑、咪康唑、噻康唑、干扰或杀灭微生物的洗涤剂类化学制剂(如壬苯醇醚-9、辛苯昔醇-9、苯扎氯铵、孟苯聚醇和正二十二烷醇);阻止微生物粘附于靶细胞和/或抑制传染病病原体进入的化学制剂(如硫酸盐和磺酸盐聚合物,如PC-515(角叉菜胶)、Pro-2000和糊精2-硫酸盐);抑制逆转录病毒在细胞内复制的抗逆转录病毒剂(如PMPA凝胶);经基因工程改造的或天然存在的抵抗病原体的抗体(诸如从植物获得经基因工程改造的抗病毒抗体,称作“植物抗体”);改变组织环境使其不利于病原体的药物(如改变粘膜pH的物质(如Buffer Gel和Acidform));可产生过氧化氢或其他杀灭或抑制致病微生物生长的物质的非致病或“有益”微生物(如乳酸杆菌);抗菌蛋白或抗菌肽(诸如美国专利No.6,716,813(Lin等人)中所述的那些,该专利以引用方式并入本文)或抗菌金属(如胶体银)。
除此之外或作为另外一种选择,在一些需要治疗或预防炎症的应用中,本发明递送的物质可以包括各种类固醇或其他抗炎剂(如非甾体抗炎剂或NSAID)、止痛药或退热剂。例如,可以使用前述鼻内给药施用的皮质类固醇,诸如倍氯米松(Vancenase或Beconase)、氟尼缩松(Nasalide)、氟替卡松丙酸酯(Flonase)、曲安奈德(Nasacort)、布地奈德(Rhinocort Aqua)、依碳酸氯替泼诺(Locort)以及莫米松(Nasonex)。也可以使用上述皮质类固醇的其他盐形式。另外,可以用于本发明的类固醇的其他非限制性实例包括(但不限于):阿氯米松、地奈德、氢化可的松、倍他米松、氯可托龙、去羟米松、氟轻松、氟氢缩松、莫米松、泼尼卡酯、安西奈德、去羟米松、双氟拉松、氟轻松、氟轻松醋酸酯、哈西奈德、氯倍他索、增强型倍他米松、双氟拉松、卤贝他索、泼尼松、地塞米松和甲泼尼龙。可用的其他抗炎剂、止痛药或退热剂包括:非选择性COX抑制剂(如水杨酸衍生物、阿司匹林、水杨酸钠、三水杨酸胆碱镁、双水杨酯、二氟苯水杨酸、柳氮磺胺吡啶和奥沙拉秦;对氨基苯酚衍生物(如对乙酰氨基酚);吲哚和茚乙酸(如消炎痛和舒林酸);杂芳基乙酸(如托美丁、双氯芬酸和酮咯酸);芳基丙酸(如布洛芬、萘普生、氟比洛芬、酮洛芬、非诺洛芬和噁丙嗪);邻氨基苯甲酸(芬那酸类)(如甲芬那酸和美洛昔康);烯醇酸(如昔康类(吡罗昔康、美洛昔康))和烷酮(如萘丁美酮))以及选择性COX-2抑制剂(诸如,二芳基取代的呋喃酮(如罗非考昔);二芳基取代的吡唑(如塞来考昔);吲哚乙酸(如依托度酸)和磺基苯胺(如尼美舒利))。
除此之外或作为另外一种选择,在一些应用(诸如需要治疗或预防变应性反应或免疫反应和/或细胞增殖的那些应用)中,本发明递送的物质可以包括:a)各种细胞因子抑制剂,诸如人源性抗细胞因子抗体、抗细胞因子受体抗体、重组(基因重组产生的新细胞)拮抗剂或可溶性受体;b)各种白三烯调节剂,诸如扎鲁司特、孟鲁司特和齐留通;c)免疫球蛋白E(IgE)抑制剂,诸如奥马佐单抗(抗IgE单克隆抗体,以前称作rhu Mab-E25)和分泌性白细胞蛋白酶抑制剂。
除此之外或作为另外一种选择,在一些应用(诸如需要收缩粘膜组织、减轻充血状况或实现止血的那些应用)中,本发明递送的物质可以包括用于减充血剂和/或止血剂目的的各种血管收缩剂,包括(但不限于)伪麻黄碱、丁苄唑啉、羟甲唑啉、去氧肾上腺素、肾上腺素等。
除此之外或作为另外一种选择,在一些应用(诸如需要有利于黏液流动的那些应用)中,本发明递送的物质可以包括调节黏液或类黏蛋白分泌物的粘度或稠度的各种黏液溶解剂或其他试剂,包括(但不限于)乙酰半胱氨酸(MucomystTM、MucosilTM)和愈创木酚甘油醚。
除此之外或作为另外一种选择,在一些应用(诸如需要预防或阻止组胺释放的那些应用)中,本发明递送的物质可以包括各种肥大细胞稳定剂或预防组胺释放的药物,诸如色甘酸(如Nasal Chrom)和奈多罗米。
除此之外或作为另外一种选择,在一些应用(诸如需要溶解、降解、切割、折断或重塑骨骼或软骨的那些应用)中,本发明递送的物质可以包括减弱或修整骨骼和/或软骨以有利于本发明其他手术(其中骨骼或软骨被重塑、整形、折断或移除)的物质。此类试剂的一个实例可以是钙螯合剂,诸如EDTA,其可注射或递送到紧邻待重塑或修整的骨骼区域的物质递送植入物中。另一个实例可以是由骨骼降解细胞组成或含有骨骼降解细胞的制剂,所述骨骼降解细胞诸如破骨细胞。其他实例可以包括可软化或分解骨骼或软骨组分的各种材料的酶,诸如胶原酶(CGN)、胰蛋白酶、胰蛋白酶/EDTA、透明质酸酶、甲苯磺酰基赖氨酰氯甲烷(TLCM)。
除此之外或作为另外一种选择,在一些应用中,本发明递送的物质可以包括其他种类的用于治疗鼻炎、鼻息肉、鼻腔炎症和其他耳鼻喉疾病的物质,包括(但不限于)趋于干燥鼻腔分泌物的抗胆碱能药,例如异丙托铵(Atrovent Nasal),以及本文未列出的其他试剂。
除此之外或作为另外一种选择,在一些应用(诸如需要从息肉或水肿性组织吸取流体的那些应用)中,本发明递送的物质可以包括局部作用利尿剂,例如速尿和/或高渗剂,诸如可从组织吸取水分的氯化钠凝胶或其他盐制剂,或可直接或间接改变黏液渗透含量以使更多水分排出组织从而使息肉直接在其位点处收缩的物质。
除此之外或作为另外一种选择,在一些应用(诸如需要治疗肿瘤或癌性病变的那些应用)中,本发明递送的物质可以包括抗肿瘤剂(如癌症化疗药、生物反应调节剂、血管形成抑制剂、激素受体阻断剂、低温治疗药或其他破坏或抑制瘤形成或肿瘤发生的试剂);诸如烷基化剂或其他通过攻击癌细胞DNA将癌细胞直接杀死的试剂(如环磷酰胺、异磷酰胺)、亚硝基脲或其他通过抑制细胞DNA修复必需的变化杀死癌细胞的试剂(如卡莫司汀(BCNU)和洛莫司汀(CCNU))、抗代谢物和其他通过干扰特定细胞功能(通常为DNA合成)阻止癌细胞生长的试剂(如6-巯嘌呤和5-氟尿嘧啶(5FU))、抗肿瘤抗生素和其他通过结合或插入DNA和抑制RNA合成发挥作用的化合物(如多柔比星、柔红霉素、表柔比星、伊达比星、丝裂霉素-C和博来霉素)、植物(长春花)生物碱和其他源自植物的抗肿瘤剂(如长春新碱和长春花碱)、类固醇激素、激素抑制剂、激素受体拮抗剂和其他影响激素反应性癌生长的试剂(如他莫昔芬、赫赛汀、芳香酶抑制剂(如氨鲁米特和福美坦)、三唑抑制剂(如来曲唑和阿那曲唑)、类固醇抑制剂(诸如依西美坦))、抗血管生成蛋白、小分子、基因治疗和/或其他抑制肿瘤血管生成或血管形成的试剂(如meth-1、meth-2、萨立多胺)、贝伐单抗(阿瓦斯汀)、角鲨胺、内皮抑素、血管抑素、Angiozyme、AE-941(新伐司他)、CC-5013(雷利米得)、medi-522(Vitaxin)、2-甲氧基雌二醇(2ME2、Panzem)、羧胺三唑(CAI)、考布他汀A4前药(CA4P)、SU6668、SU11248、BMS-275291、COL-3、EMD121974、IMC-1C11、IM862、TNP-470、塞来考昔(西乐葆)、罗非考昔(万络)、干扰素α、白介素-12(IL-12)或Science Vol.289,Pages 1197-1201(August 17,2000)(《科学》,第289卷,第1197-1201页(2000年8月17日),其明确地以引用方式并入本文)中鉴定的任何化合物、生物反应调节剂(如干扰素、卡介苗(BCG)、单克隆抗体、白介素-2、粒细胞集落刺激因子(GCSF)等)、PGDF受体拮抗剂、赫赛汀、天冬酰胺酶、白消安、卡铂、顺铂、卡莫司汀、苯丁酸氮芥、阿糖胞苷、达卡巴嗪、依托泊苷、氟酮磺隆、氟脲嘧啶、吉西他滨、羟基脲、异环磷酰胺、伊立替康、洛莫司汀、美法仑、巯嘌呤、甲氨蝶呤、硫鸟嘌呤、噻替哌、拓优得、拓扑替康、曲奥舒凡、长春碱、长春新碱、mitoazitrone、奥沙利铂、丙卡巴肼、灰链菌素、紫杉酚、泰素帝、此类化合物的类似物/同类物和衍生物以及本文未列出的其他抗肿瘤剂。
除此之外或作为另外一种选择,在一些应用(诸如需要生长新细胞或修饰现有细胞的那些应用)中,本发明递送的物质可以包括细胞(粘膜细胞、成纤维细胞、干细胞或经基因工程改造的细胞)以及基因和基因递送载体(如质粒、腺病毒载体或裸DNA、mRNA等,其连同编码抗炎物质等的基因一起注入),以及如果需要的话,如上文提及的修整或软化骨骼的破骨细胞。
本文所述的任何装置和方法也可以用于向脑递送物质或改变嗅觉系统的功能。此类实例包括:递送能量或设置装置和/或物质和/或递送物质植入物,以闭塞或改变嗅知觉、抑制食欲或换句话讲治疗肥胖、癫痫症(如巴比妥酸盐(诸如苯巴比妥或甲基苯巴比妥);亚氨基芪(诸如卡马西平和奥卡西平);琥珀酰亚胺(诸如乙琥胺);丙戊酸;苯二氮卓类(诸如氯硝西泮、氯氮卓、安定和劳拉西泮)、加巴喷丁、拉莫三嗪、乙酰唑胺、非氨酯、左乙拉西坦、噻加宾、托吡酯、唑尼沙胺等)、人格障碍和精神疾病(例如抗抑郁药、抗焦虑药、安定药等)、慢性病、帕金森病(如多巴胺受体拮抗剂,诸如溴麦角环肽、培高利特、罗匹尼罗和普拉克索;多巴胺前体,如左旋多巴;COMT抑制剂,诸如托卡朋和恩他卡朋;司立吉林;毒蕈碱受体拮抗剂,如苯海索、苯托品和苯海拉明)以及阿尔茨海默病、亨廷顿舞蹈症或其他痴呆、认知能力疾病或慢性退行性疾病(如他克林、多奈哌齐、利凡斯的明、加兰他敏、氟西汀、卡马西平、氯氮平、氯硝西泮以及抑制β-淀粉样斑块形成的蛋白质或基因治疗)等。
本文所公开的装置和方法可以用于向合适的目标解剖区域递送本文所公开的两种或更多种物质的若干组合。在一个具体实施例中,本文所公开的装置和方法用于递送抗炎剂(如类固醇或NSAID)和黏液溶解剂的组合。
本文所公开的装置和方法可以用于向解剖区域(诸如鼻旁窦)递送包含一种或多种物质的凝胶或粘稠的液体。此类凝胶或粘稠的液体可以涂覆和附着到粘膜,并因此向粘膜提供一种或多种物质的持续递送。在一个实施例中,可以向粘膜(诸如鼻旁窦粘膜)递送包含明胶、果胶和羧甲基纤维素钠的增塑烃凝胶以及合适的物质。此类凝胶可用于向粘膜持续递送合适物质。
本文所公开的一种或多种物质贮存器可以包括多个隔室,使得每一个隔室都贮存特定的物质制剂。多个隔室可抑制多种物质制剂在递送到解剖结构前发生混合。
一种或多种包括洞或孔的物质贮存器可以足够的高压填充合适的物质,以使一部分物质喷出洞或孔。该方法可以用于向周围的解剖结构递送初始量的物质。
本文所公开的一种或多种物质贮存器可以在所述物质贮存器引入到解剖区域后填充合适的物质。作为另外一种选择,本文所公开的一种或多种物质贮存器可以在所述物质贮存器引入到解剖区域前填充合适的物质。作为另外一种选择,本文所公开的一种或多种物质贮存器可以预填充固体、冻干或浓缩的物质。通过向物质贮存器引入溶剂,使所述固体、冻干或浓缩的物质转变为活性形式。该步骤可以在物质贮存器引入到解剖区域之前或之后完成。作为另外一种选择,本文所公开的一种或多种物质贮存器可以预填充物质的非活性形式。通过向物质贮存器引入活化剂,使所述物质的非活性形式转变为活性形式。该步骤可在物质贮存器引入到解剖区域之前或之后完成。
还应认识到,如本文所述,物质递送垫片装置10的可植入的部分可以包括直通中央腔,所述直通中央腔可以在此类可植入的部分装置位于鼻旁窦、气房、耳咽管、耳膜或体内任何其他位置形成的开口内时用作通气口和/或引流管。
本文所公开的装置和方法可以用于以合适的可成像标记物标记解剖区域。例如,本文所公开的装置和方法可以用于向鼻旁窦口递送射线不可透的标记物,诸如射线不可透的造影剂。这使用户能够使用X射线或荧光检查对鼻旁窦口成像。
本文所公开的一种或多种物质递送装置可以包括弯曲或倾斜区域,以使药物递送装置能够导入解剖结构。
本文所公开的一种或多种物质递送装置的最远侧区域可以包括无创伤顶端。无创伤顶端用于抑制或减少所述一种或多种物质递送装置的最远侧区域对解剖结构的损伤。
本文所公开的一种或多种物质递送装置的外表面可以包括涂层,所述涂层可降低或消除生物材料包被外表面的风险。在一个实施例中,涂层包含可吸收水形成凝胶的材料。此类材料的实例包括(但不限于)透明质酸等。
本文所公开的一种或多种物质递送装置可以被设计为可在治疗完成后从解剖结构轻松移除。
本文所公开的一种或多种物质递送装置可以在填充于物质贮存器中的显著体积的物质递送到解剖结构后再次充满。
本文所公开的一种或多种物质递送装置可以包括一种或多种标记物,以使用户能够将物质递送装置定位和/或导入到解剖结构中。例如,物质递送装置可以包括视觉标记物,以使用户能够确定物质递送装置插入解剖结构的深度。又如,物质递送装置可以包括成像标记物,以使用户能够使用成像技术如X射线、MRI等定位和/或导入物质递送装置。
如本文所用,术语“鼻旁窦的开口”应该包括鼻旁窦或气房中的任何开口,诸如自然口、经外科手术改变的自然口、经外科手术生成的开口、窦造口术开口、截骨术开口、打孔、钻孔、筛窦切开术开口、筛房切除术开口、自然或人造通道等。
如本文所用,术语“可植入的”应该包括可在人或动物体内维持30分钟至60天的时间的任何装置。
在上述使用了内窥镜400的实例中的每一个中,显示内窥镜400与其他装置分开插入。然而,在本发明任何可行的应用或实施例中,内窥镜可以连接到如专利申请序列No.中所述手术过程中使用的一种或多种其他装置或与其结合。
应当认识到,以上实例2和实例3描述了可以用于将垫片装置10引入额窦中的技术,所述额窦之前可能通过或可能没有通过外科手术或在球囊扩张术前改变。在一些情况下,诸如额窦流出道之前已通过外科手术扩张或调整,以使得额窦FS相对容易进入的情况下,操作者可以穿过约束管42(或额窦护套40、40a)轻松地将垫片装置10递送到额窦中,使用或不使用钳子或其他手术器械,由此不必使用导向导管、导丝、扩张器或其他用于导向或有利于将垫片装置10推进到如实例2和实例3中所述额窦的装置中。
还应该认识到,虽然上文的实例1、实例2和实例3描述了曲安奈德可注射悬浮液(Kenalog40,Brystol-Myers Squibb公司(Princeton,NewJersey))作为治疗剂填充到贮存器并从其洗脱出来,但除该曲安奈德可注射悬浮液外或作为其替代,可以使用多种其他治疗剂。在一些需要使用植入的垫片装置10a递送类固醇的情况下,类固醇可以制备为溶液,而非悬浮液。在此类情况下,类固醇将溶解于合适的生物相容溶剂中。例如,已有描述环糊精可作为溶解至少一些类固醇的合适溶剂。Khomutov,S.M.、Dovbnya,D.V.和Donova,M.V.的Dissolution of a Mixture of Steroids inCyclodextrin Solutions:a Model Description;Pharmaceutical Chemistry Journal;Vol.35,No.1i,pp.627-629(November,2001)(“环糊精溶液中类固醇混合物的溶解:模型描述”,《药物化学杂志》,第35卷,第1i期,第627-629页(2001年11月))。
在某些情况下,本发明的装置可用于递送制剂形式的类固醇或其他物质,所述制剂为可作为滴鼻剂或喷鼻剂(即鼻腔溶液)商购得到或换句话讲适于鼻腔内递送到鼻粘膜的制剂。在至少一些情况下,制备此类鼻腔溶液,以使得它们类似于鼻腔分泌物,因此不会干扰正常的纤毛运动。此类鼻腔溶液通常为等渗的溶液,并稍许缓冲到pH值为5.5至6.5。另外,如果需要的话,制剂中还可以包括抗微生物防腐剂(类似于用于眼科制剂的那些)和合适的药物稳定剂。已知多种市售鼻用制剂,包括(例如)抗生素、类固醇、抗组胺剂、减充血剂和异丙托溴铵。
在可行和适当时,本发明装置递送的任何物质可以是脂质体或纳米颗粒形式(如毫微囊)。脂质体的形成和使用通常为本领域的技术人员所知。脂质体由分散于含水介质中的磷脂形成,使得它们自发形成复层同心双层囊泡,有时称为多层囊泡(MLV)。MLV的直径通常为25nm至4μm。MLV经超声处理后形成直径为约200埃至500埃并具有包含水溶液的芯的单层小囊泡(SUV)。通常,磷脂分散于含水介质中时,根椐脂质与水的摩尔比,可形成除脂质体之外的多种结构。在脂质与水的摩尔比较低时,将形成脂质体。脂质体的物理性质取决于pH、渗透压和有无二价阳离子存在。脂质体可通过不同机理与细胞相互作用,包括:1)内吞作用(如脂质体被细胞如巨噬细胞和中性粒细胞吞噬)、吸附到细胞表面;2)与细胞表面组分相互作用;3)通过将脂质体的脂质双层插入到质膜中而与细胞质膜融合;或4)将脂质体脂质转移到细胞膜或亚细胞膜,反之亦然。改变脂质体组成可改变脂质体与鼻旁窦、鼻粘膜等中的细胞相互作用的机理。
毫微囊是任何由外壳和空间组成的纳米颗粒,其中可以设置所需的物质。用于形成毫微囊的技术在本领域是已知的技术。聚合物毫微囊可制成特定大小和形状。它们可制成单分散颗粒,其具有精确定义的物理和化学性质,因此可定制为有利于治疗或诊断物质在响应特定双分子触发机制(诸如pH、黏液流或其他存在于鼻旁窦内或装置植入的耳鼻喉中的其他区域内的环境)时释放。毫微囊在本发明中可用作“智能药物”,所述“智能药物”具有特定化学受体或结合位点,所述受体或结合位点将结合特定靶细胞(如鼻窦肿瘤或鼻腔肿瘤相关癌细胞或炎性病症相关细胞)。
应该认识到,以上结合本发明的某些实例或实施例对本发明进行了描述,但在不脱离本发明的预期精神和范围的前提下,可以对这些实例和实施例进行各种添加、删除、变型和修改。例如,可以将一个实施例或实例的任何元件或属性整合到另一个实施例或实例中或与之一起使用,除非另外指明,否则这样做将会使得实施例或实例不适合于其预期用途。另外,虽然按具体顺序描述或列出了方法的步骤,但可以改变这种步骤的顺序,除非另外指明,否则这样做将会使得该方法不能实现其预期目的。所有适当的添加、删除、修改和更改都应视为所述实例和实施例的等同形式,并应包括在以下权利要求书的范围内。
Claims (19)
1.一种用于向额鼻旁窦递送物质的物质递送窦垫片系统,包括:
弯曲的递送导向装置,所述导向装置能够延伸穿过鼻孔,以将所述导向装置的远端定位在额鼻旁窦口中或其附近,而所述导向装置的近端位于所述鼻孔的外部;
细长的物质递送导管,所述导管具有近端和远端;和
物质递送窦垫片装置,所述垫片装置从所述递送导管的所述远端伸出并与其流体连通,所述垫片装置包括:
细长的管轴,所述管轴具有无创伤顶端;
可扩张式贮存器,所述贮存器连接到所述管轴并且所述治疗性物质可以填充到所述管轴中;和
至少两个可伸缩的保持构件,所述保持构件能够与所述贮存器相邻并与其纵向重叠。
2.根据权利要求1所述的系统,还包括护套,所述护套可拆卸地设置在所述窦垫片装置的上方,以将所述保持构件保持为收缩构型,所述护套在其近端处或其近端附近包括阻挡件,以用于阻挡所述护套穿过所述递送导向装置的推进。
3.根据权利要求2所述的系统,其中所述物质递送导管包括沿其长度的部分设置的标记物,使得当所述递送导管和所述护套推进到所述导向装置时,并且当所述标记物的远端到达所述护套的所述近端时,所述窦垫片的所述无创伤顶端被定位在所述导向装置的所述远端处,并且当所述标记物的近端到达所述护套的所述近端时,所述可伸缩的保持构件被定位在所述导向装置的所述远端的外部。
4.根据权利要求1所述的系统,其中所述弯曲的递送导向装置包括刚性的近侧部分和柔性弯曲的远侧部分。
5.根据权利要求4所述的系统,其中所述递送导向装置还包括射线不可透的远侧顶端。
6.根据权利要求1所述的系统,其中所述物质递送导管为不透明的导管,所述窦垫片装置为半透明的装置。
7.根据权利要求1所述的系统,还包括缝线套环,所述缝线套环与所述窦垫片装置连接,以用于将所述窦垫片连接到所述鼻腔或额窦流出道的内部的组织。
8.根据权利要求1所述的系统,其中所述导管还包括鲁尔连接器,所述鲁尔连接器与其近端连接,以用于将所述导管与所述物质源连接。
9.根据权利要求1所述的系统,还包括柄部,所述柄部可拆卸地与所述导向装置的所述近端连接。
10.根据权利要求1所述的系统,还包括一定量的所述物质。
11.根据权利要求1所述的系统,其中所述物质包括类固醇。
12.根据权利要求11所述的系统,其中所述类固醇包括曲安奈德。
13.根据权利要求1所述的系统,其中所述窦垫片装置的所述贮存器具有基本上圆柱形的侧壁和锥形末端,在所述贮存器的所述侧壁和所述锥形末端中形成开口,使得填充到所述贮存器中的治疗性物质将穿过所述开口从所述贮存器洗脱出来。
14.根据权利要求2所述的系统,其中每一个开口的直径都为约20微米至约40微米。
15.根据权利要求1所述的系统,其中所述窦垫片装置的所述保持构件包括环状翼。
16.根据权利要求15所述的系统,其中所述保持构件呈扩张构型时的翼展为介于约13mm和约16mm之间。
17.根据权利要求1所述的系统,其中所述保持构件在所述管轴上完全相对。
18.根据权利要求1所述的系统,其中所述保持构件沿着所述垫片装置的纵向维度交错。
19.根据权利要求1所述的系统,其中所述保持构件沿着所述管轴的同侧连接。
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PCT/US2009/069143 WO2010078145A1 (en) | 2008-12-22 | 2009-12-22 | Frontal sinus spacer |
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2008
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2009
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- 2009-12-22 CA CA2747982A patent/CA2747982A1/en not_active Abandoned
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- 2009-12-22 AU AU2009333010A patent/AU2009333010B2/en not_active Ceased
- 2009-12-22 WO PCT/US2009/069143 patent/WO2010078145A1/en active Application Filing
- 2009-12-22 MX MX2011006763A patent/MX2011006763A/es not_active Application Discontinuation
- 2009-12-22 JP JP2011542562A patent/JP5602762B2/ja not_active Expired - Fee Related
- 2009-12-22 CN CN2009801529950A patent/CN102256658A/zh active Pending
- 2009-12-22 KR KR1020117017365A patent/KR20110106413A/ko active Search and Examination
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2014
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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CN109310284A (zh) * | 2016-04-19 | 2019-02-05 | 波士顿科学国际有限公司 | 渗液球囊装置 |
CN105999529A (zh) * | 2016-07-05 | 2016-10-12 | 杨振九 | 鼻腔深部给药设备 |
CN109419583A (zh) * | 2017-08-31 | 2019-03-05 | 阿克拉伦特公司 | 开放的咽鼓管支架 |
CN107997802A (zh) * | 2018-01-11 | 2018-05-08 | 四川大学华西医院 | 骨间隙精确止血装置 |
Also Published As
Publication number | Publication date |
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CA2747982A1 (en) | 2010-07-08 |
US8764729B2 (en) | 2014-07-01 |
JP5602762B2 (ja) | 2014-10-08 |
US20140336575A1 (en) | 2014-11-13 |
KR20110106413A (ko) | 2011-09-28 |
US20170312485A1 (en) | 2017-11-02 |
RU2011130530A (ru) | 2013-01-27 |
BRPI0923533A2 (pt) | 2016-01-26 |
US10441758B2 (en) | 2019-10-15 |
US9649477B2 (en) | 2017-05-16 |
RU2494768C2 (ru) | 2013-10-10 |
WO2010078145A1 (en) | 2010-07-08 |
MX2011006763A (es) | 2011-08-03 |
EP2373372A1 (en) | 2011-10-12 |
US20090198216A1 (en) | 2009-08-06 |
AU2009333010B2 (en) | 2015-07-02 |
JP2012513253A (ja) | 2012-06-14 |
AU2009333010A1 (en) | 2010-07-08 |
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