CN101795641B - 多致动触发器锚固输送系统 - Google Patents
多致动触发器锚固输送系统 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
- A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0417—T-fasteners
Abstract
为了治疗疾病或失调或其它目的的医疗用途中的用于操纵组织和解剖结构或其它结构的单触发器系统和关联的方法。在一个方面,该系统包括输送装置,该输送装置设置成以便部署和移植用于这些目的的锚固装置。
Description
技术领域
本发明大致上涉及医疗装置和方法,并且更具体地,涉及为了治疗疾病或失调的目的和/或为了美容或整形(reconstructive)或其它目的的用于操纵或收回人体内或动物对象(animal subject)体内的组织以及解剖结构或其它结构的系统和相关的方法。
背景技术
存在有多种多样的需要提升、压缩或以其它形式复位人体内或动物对象体内的正常的或畸变的组织或解剖结构(例如器官、韧带、肌腱、肌肉、肿瘤、囊肿、脂肪垫等)的情形。这些手术经常为了治疗或减轻疾病或失调(例如增生症、肥大症、瘤形成、下垂、疝形成、狭窄症、收缩(constriction)、压缩、移位、先天性畸形等等)的影响的目的和/或为了美容的目的(例如面部加高、胸部加高、眉毛加高等等)和/或为了研究和发展的目的(例如为了产生模仿各种病理学症状的动物模型)而被执行。在很多这些手术中,要在身体中做出外科切口,并且要实施艰难的外科解剖以接近受到影响的组织或解剖结构并使受到影响的组织或解剖结构暴露。之后,在一些案例中,受到影响的组织或解剖结构被移除或切除。在其它案例中,各种自然的或人造的材料将被用于加高、悬吊(sling)、复位或压缩受到影响的组织。
良性前列腺增生(BPH)
需要加高、压缩或以其它形式移除病理学上放大的组织的情况的一个例子是良性前列腺增生(BPH)。BPH是影响男性特别是老年男性的最常见的医学疾病之一。已经报道,在美国,多于一半的男性在60岁时具有BPH的组织病理学迹象(histopathologic evidence),并且在85岁时,大约十分之九的男性患有该疾病。此外,预期在发达国家中,BPH的发生率和流行程度将随着人口平均年龄的增加而增加。
前列腺在男性的生命中自始至终放大。在一些男性中,围绕前列腺的前列腺囊可以防止前列腺继续放大。这引起前列腺的内部区域压迫尿道。尿道上的此压力增加了尿流动穿过被前列腺围住的尿道区域的阻力。因此,膀胱必须施加更多压力以迫使尿穿过增加了阻力的尿道。长期的过度用力会引起膀胱的肌肉壁改型并变得较僵硬。对尿流的增加的尿道阻力和僵硬以及膀胱壁肥大的此种组合导致可能严重地降低患者的生活质量的多种下尿路症状(LUTS)。这些症状包括:排尿时衰弱的或间歇性的尿流、排尿时紧张、尿流开始前犹豫、甚至在排尿后感到膀胱没有被完全地排空、在排尿结束时滴落或在排尿后渗漏、特别是在夜间增加的排尿频率、尿急等等。
除患有BPH的患者外,LUTS也可能存在于患有前列腺癌、前列腺感染的患者中,以及长期使用会引起尿潴留的某些药物(例如麻黄素、伪麻黄素、苯丙醇胺、抗组织胺比如苯海拉明(diphenhydramine)、氯苯吡胺等等)的特别是患有前列腺增大的男性患者中。
虽然BPH很少是威胁生命的,但是它可以导致大量的临床疾病,包括尿潴留、肾功能不全、复发性尿路感染、失禁、血尿症以及膀胱结石。
在发达国家中,大百分比的患者人口接受针对BPH症状的治疗。已经估计,到80岁时,大约25%的美国男性人口将接受一些形式的BPH治疗。当前,针对BPH的可用的治疗选择包括观察等待、药物治疗(植物疗法和处方药)、外科手术以及微创手术。
对于选择了观察等待选项的患者,不对患者提供即时的治疗,而是使患者接受规则的检查以监测疾病的发展。这通常在具有最小症状的不会特别地引起麻烦的患者身上完成。
用于治疗BPH症状的药物治疗包括植物疗法和处方药。在植物疗法中,植物产品比如锯叶棕(Saw Palmetto)、非洲臀果木(AfricanPygeum)、锯棕果(Serenoa Repens)(西谷椰子(sago palm))以及南非星草被施加到患者。在患有干扰他们的日常活动的症状的患者中,处方药被规定为一线治疗。两类主要的处方药为α-1a-肾上腺素受体阻断剂(alpha-1a-adrenergic receptor blocker)和5-α-还原酶抑制剂(5-alpha-reductase inhibitor)。α-1a-肾上腺素受体阻断剂阻断负责引起前列腺中的平滑肌细胞的收缩的α-1a-肾上腺素受体的活动。因此,阻断α-1a-肾上腺素受体的活动引起前列腺平滑肌放松。这进而减小了尿道阻力,从而减小了症状的严重度。-α-还原酶抑制剂阻断睾丸素转化成二氢睾酮。二氢睾酮引起前列腺中上皮细胞的生长。因此,5-α-还原酶抑制剂引起前列腺中上皮细胞的退化,并因此减小前列腺的体积,这进而减小症状的严重度。
用于治疗BPH症状的外科手术包括经尿道前列腺切除术(TURP)、经尿道前列腺电汽化(TVP)、经尿道前列腺切开术(TUIP)、激光前列腺切除术以及开放式前列腺切除术。
经尿道前列腺切除术(TURP)是为了治疗BPH最常被实施的外科手术。在此手术中,通过移除大多数前列腺尿道以及周围的前列腺的相当大的体积,前列腺尿道梗阻被减小。这是在全身麻醉或脊椎麻醉之下执行的。在此手术中,泌尿科医生通过将装有与视频摄像机联通的光学透镜的前列腺切除器插入尿道以便前列腺切除器的远端区域位于被前列腺围绕的尿道区域中来观察尿道。前列腺切除器的远端区域由电切割环组成,当电流被施加到该装置时,该电切割环可以切割前列腺组织。电动返回衬垫(electric return pad)被放置在患者身上,以便关闭切割电路。电动切割环被用于从前列腺的内部刮去组织。通过使用冲洗流体,被刮去的组织被冲洗出泌尿系统。通过使用凝血能量设置(coagulation energy setting),在操作过程中,该环也被用于烧灼横断的脉管。
用于治疗BPH症状的外科手术的另一个例子是经尿道前列腺电汽化(TVP)。在此手术中,压迫尿道的前列腺组织的一部分被脱水或蒸汽化。这是在全身麻醉或脊椎麻醉之下执行的。在此手术中,前列腺切除器经尿道插入,以便前列腺切除器的远端区域位于被前列腺围绕的尿道区域中。前列腺切除器的远端区域由滚珠或有槽的滚子电极组成。受控制的量的电流流过电极。周围组织被迅速地加热并蒸汽化以产生蒸汽化空间。因此,被周围的前列腺阻断的尿道区域被打开。
用于治疗BPH症状的外科手术的另一个例子是经尿道前列腺切开术(TUIP)。在此手术中,通过在前列腺中在尿道与膀胱会合的区域中做出一个或多个切口,来减小尿流的阻力。此手术是在全身麻醉或脊椎麻醉之下实施的。在此手术中,膀胱颈部的肌肉中被做出一个或多个切口,膀胱颈部是尿道与膀胱会合的区域。这些切口在大部分案例中足够深,以便切割周围的前列腺组织,包括前列腺囊。这释放了膀胱颈部上的任何压力,并引起膀胱颈部弹开去。这些切口可以通过使用前列腺切除器、激光束等来制作。
用于治疗BPH症状的外科手术的另一个例子是激光前列腺切除术。用于激光前列腺切除术的两种常见技术是前列腺可视激光烧蚀术(VLAP)以及前列腺钬激光切除/剜除术(HoLEP)。在VLAP中,钕:钇铝石榴石(Nd:YAG)激光被用于通过引起凝固性坏死来烧蚀组织。该手术是在视觉引导下实施的。在HoLEP中,钬:钇铝石榴石激光被用于引导组织的直接接触烧蚀。这些技术都被用于移除妨碍尿道通路的组织,以便较小BPH症状的严重度。
用于治疗BPH症状的外科手术的另一个例子是前列腺的光选择性蒸汽化(PVP)。在此手术中,激光能量被用于蒸汽化前列腺组织,以便减轻对于尿道中尿流的妨碍。所使用的激光类型为磷酸钛氧钾(KTP)激光。此激光的波长高度地被氧基血红素吸收。此激光使细胞水分蒸汽化,并因此被用于移除妨碍尿道的组织。
用于治疗BPH症状的外科手术的另一个例子是开放式前列腺切除术。在此手术中,前列腺通过开放式外科手术被外科地移除。这是在全身麻醉下完成的。前列腺通过下腹部或会阴中的切口被移除。此手术大多数情况下被用于患有巨大(大于大约100克)前列腺的患者中。
用于治疗BPH症状的微创手术包括经尿道微波热疗法(TUMT)、经尿道针刺烧蚀(TUNA)、间隙激光凝固(ILC)以及前列腺支架。
在经尿道微波热疗法(TUMT)中,微波能量被用于产生破坏增生的前列腺组织的热量。此手术是在局部麻醉下实施的。在此手术中,微波天线被插入尿道。直肠热感应单元(rectal thermosensing unit)被插入直肠以测量直肠温度。直肠温度测量被用于防止解剖区域的过热。微波天线随后被用于将微波输送到前列腺的侧叶(lateral lobe)。微波在穿过前列腺组织时被吸收。这产生热量,热量进而破坏前列腺组织。对前列腺组织的破坏减小了尿道被前列腺压迫的程度,从而减小了BPH症状的严重度。
用于治疗BPH症状的微创手术的另一个例子是经尿道针刺烧蚀(TUNA)。在此手术中,前列腺组织区域的热量引起的凝固性坏死引起前列腺收缩。这是通过使用局部麻醉和静脉注射或口服镇静剂(intravenous or oral sedation)来实施的。在此手术中,输送导管被插入尿道。该输送导管包括两个射频针,这两个射频针以90度角从输送导管露出。这两个射频针彼此成40度角排列,以便它们穿透前列腺的侧叶。对于每处病变来说,射频电流被输送经过射频针,以在大约456KHz的射频功率下将侧叶的组织加热到70至100摄氏度达大约4分钟。这在侧叶中产生凝固缺陷。该凝固缺陷引起前列腺组织的收缩,这进而减小了尿道被前列腺压迫的程度,从而减小了BPH症状的严重度。
用于治疗BPH症状的微创手术的另一个例子是间隙激光凝固(ILC)。在此手术中,激光引起的前列腺组织区域的坏死引起前列腺收缩。这是通过使用区域麻醉、脊椎麻醉或硬膜外麻醉或局部麻醉(前列腺周围阻断)而实施的。在此手术中,膀胱镜护套被插入尿道,并且尿道被前列腺包围的区域被检查。激光纤维被插入尿道。激光纤维具有锋利的远端尖端,以促进激光观察器穿透前列腺组织。激光纤维的远端尖端具有远端扩散区域,该远端扩散区域沿着激光纤维的3mm终端360度地分配激光能量。该远端尖端被插入前列腺的中叶,并且激光能量被输送经过远端尖端达所需的时间。这加热了中叶,并导致激光引起围绕远端尖端的组织的坏死。随后,远端尖端被从中叶撤回。对侧叶重复将远端尖端插入叶并输送激光能量的相同的手术。这引起前列腺的若干区域中的组织坏死,进而引起前列腺收缩。前列腺的收缩减小了尿道被前列腺压迫的程度,从而减小了BPH症状的严重度。
用于治疗BPH症状的微创手术的另一个例子是移植前列腺支架。在此手术中,被前列腺围绕的尿道区域被机械地支撑,以减小由放大的前列腺引起的收缩。前列腺支架为在被插入尿道后膨胀的柔性装置。它们通过将妨碍性的前列腺组织从尿道推开而机械地支撑尿道。这减小了尿道的收缩,并改进了经过前列腺的尿流,从而减小了BPH症状的严重度。
虽然现有的治疗能对患者提供BPH症状的一些减轻,但是它们具有缺点。α-1a-肾上腺素受体阻断剂具有副作用,比如眩晕、体位性低血压、头重感、无力以及鼻塞。也可能发生逆向射精。5-α-还原酶抑制剂具有微小的副作用,而且仅仅对BPH症状和尿流速度具有不太大的影响。另外,抗雄激素比如5-α-还原酶,在观察到LUTS改进之前需要数月的治疗。BPH的外科治疗带有并发症的风险,这些并发症包括:勃起功能障碍;逆向射精;尿失禁;与麻醉有关的并发症;对阴茎或尿道的损害、需要重复外科手术等。甚至作为BPH的治疗中的黄金标准的TURP,也带有并发症的高风险。报道与此手术有关的负面事件包括逆向射精(65%的患者)、手术后刺激(15%)、勃起功能障碍(10%)、需要输液(8%)、膀胱颈部收缩(7%)、感染(6%)、严重血尿(6%)、急性尿潴留(5%)、需要二次手术(5%)以及失禁(3%)。典型的从TURP的恢复涉及若干天的使用留置导尿管的住院治疗,接下来的若干周中妨碍性症状被减轻,但在排尿的过程中会有疼痛或不适。
微创手术之后症状评分的减小不像TURP之后症状评分的减小那么大。多至25%的接受这些微创手术的患者最终在2年内接受TURP。症状评分的改进在手术后一般不立即发生。例如,对于患者来说,在TUMT之后,平均需要一个月来注意到症状的改进,而在ILC之后,平均需要1.5个月来注意到改进。实际上,对于加热或蒸煮组织的这些治疗来说,由于发生在手术后的开始几周中的肿胀和和坏死,症状一般是更糟的。前列腺支架通常可以对妨碍提供较直接的减轻,但是,现在由于其高不良反应发生率而很少被使用。支架有从初始移植部位迁移(多达12.5%的患者)、结壳(多达27.5%)、失禁(多达3%)以及复发性疼痛和不适的风险。在公开的研究中,这些不良反应使得8%到47%的支架需要被外植。组织穿过支架的过度发育以及支架复杂的几何形状使得它们的移除非常困难,并且有侵入性。
因此,治疗BPH的大多数有效的当前的方法带有不良反应的高风险。这些方法和装置需要全身麻醉或脊椎麻醉或者具有潜在的不良反应,这些不良反应要求手术在外科手术室内实施,随后是患者的住院。带有较低的不良反应风险的治疗BPH的方法也与症状评分的较低的减小有关。虽然这些手术中的若干种可以通过在办公室设施中在局部止痛的情况下来执行,但是患者的症状不会立即缓解,并且,实际上在手术之后经常经历更糟的症状达数周,直到身体开始痊愈。另外,所有的装置方法都要求在膀胱中放置尿道导管,在一些案例中放置达数周。在一些案例中指示了导尿术,因为治疗实际上会在手术后的一段时间内引起妨碍,并且在其它案例中指示了导尿术,因为手术后出血以及潜在的闭塞性血栓形成。虽然药物疗法易于实施,但是其结果不是最佳的,其需要相当长的时间产生效果,并且经常带来不所需的副作用。
尿失禁(UI)
很多女性在生完孩子之后或在老龄时经历膀胱控制力的丢失。此疾病广泛地被称为尿失禁(UI)。UI的严重度不尽相同,并且在严重的案例中,该紊乱可以完全使人衰弱,致使患者很大程度上呆在家里。这通常与膀胱突出症有关,膀胱突出症由膀胱的颈部松垂进入阴道甚至松垂到阴道外部而引起。
对于UI的治疗包括行为疗法、肌肉强化练习(例如凯格尔练习(Kegel exercise))、药物疗法、骨盆神经的电刺激、阴道内装置的使用以及外科手术。
在UI的若干案例中,外科手术通常是最佳的治疗选择。一般地,用于治疗UI的外科手术尝试加高和支撑膀胱,以便膀胱和尿道在骨盆腔内返回到它们的正常位置。实施这些外科手术的两种最常见的方法是通过形成在腹壁中的切口或者通过阴道壁。
大量的不同的外科手术已经被用于治疗UI。用于这些手术的名称包括Birch手术(Birch Procedure)、Marshall-Marchetti手术(Marshall-Marchetti Operation)、MMK、耻骨阴道悬吊(Pubo-Vaginal Sling)、跨阴道吊带手术(Trans-Vaginal TapeProcedure)、尿道悬挂、膀胱尿道悬挂。这些手术一般地分为两类,即a)耻骨后悬挂手术,以及b)悬吊手术。
在耻骨后悬挂手术中,切口一般被制作在腹壁中肚脐下方几个英寸处,并且放置有连接器网络以便支撑膀胱颈部。连接器被锚固到耻骨以及骨盆内的其它结构,实质上形成支撑膀胱的托架。
在悬吊手术中,切口一般被制作在阴道壁中,并且手工制作了自然组织或合成(人造)材料的悬带(sling)以支撑膀胱颈部。悬带的两端可以被连接到耻骨或者刚好在耻骨上方绑在腹部的前面。在一些悬吊手术中,合成吊带被用于形成悬带,并且合成吊带的端部没有被绑结而是被向上拉起到耻骨上方。
随着切口痊愈,用于治疗UI的外科手术一般地与显著的不适相关,并且可能要求Foley导尿管或在耻骨上的导尿管,以便在手术之后保持其处于原位置达至少若干天。因此,现有技术存在有对于发展用来治疗UI的具有较少的手术后不适以及对于手术后导尿的要求较少的微创(例如无切口)手术的需要。
美容的或整形的组织加高和复位
很多美容的或整形的外科手术涉及自然组织、自然组织或人造移植物或畸变的组织的加高、压缩或复位。例如,外科手术比如面部加高、眉毛加高、颈部加高、腹部整形(tummy tuck)等已经变成常事。在很多案例中,这些手术是通过穿过皮肤产生切口;切开到达肌肉以及筋膜下面的平面;将肌肉、筋膜和重叠的皮肤从下面的结构(例如骨或其它肌肉)放松;加高或复位放松的肌肉、筋膜以及下面的皮肤以及随后将已复位的组织连接到下面的或邻近的结构(例如骨、骨膜、其它肌肉)以便将已复位的组织保持在它们的新(例如加高的)位置而实施的。在一些案例中,多余的皮肤在手术过程中也可以被移除。
已经尝试发展用于组织的美容的加高和复位的微创手术装置和方法。例如,已经发展了连接器悬挂加高,其中,标准的或改进的连接器螺纹的一端被连接到肌肉,并且另一端被锚固到骨、骨膜或另一结构,以便根据需要加高和复位组织。这些连接器悬挂技术中的一些已经通过被插入通过穿刺伤口的相对小的切口的插管或针而被实施。
仍然有对于发展可以被用于想要加高、压缩、支撑或复位身体内的组织或器官的具有较小的手术中的创伤、较少的手术后不适和/或较短的恢复时间的各种手术的新设备和方法的需要。另外,存在有对于容易并且方便在介入性手术中采用的装置和相关的方法的需要。具体地,存在有对于能完成接近介入性部位的实质上自动化的装置以及介入性装置在该部位的组装和输送的需要。
本发明解决了这些以及其它需求。
发明内容
简洁地,并且总的来说,本发明涉及一种用于在患者的身体内部署锚固组件(anchor assembly)的设备和方法。本发明的设备包括经由多致动触发器(multi-actuating trigger)移动的各种子组件。这些子组件的操作被协调和同步化,以便最小化操作者的步骤,并确保单锚固组件或多锚固组件的准确和精确的移植。
在一个实施方式中,本发明的多致动触发器锚固输送系统(multi-actuating trigger anchor delivery system)包括可操作地连接到核心组件(core assembly)的把手组件。该把手组件可以恒定地连接到核心组件,或者核心组件可以为可连接到把手组件的,以便把手可以和多核心组件一起使用较长的时间。该核心组件罩住多个部件,以便构造成锚固组件。把手组件还包括摇臂组件、线轴或旋转组件以及触发器组件,这些组件相配合以完成输送系统的各种功能。具体地,一方面,线轴组件包括使用充足的能量加载的一个或多个弹簧组件,以便推进和部署用于多锚固组件的部件。线轴组件特别有优势,因为其允许至少6cm长的若干锚固组件各自被储存在配合在用户的手中的相对小的装置中。其优势还在于,其允许医师将装置只插入患者一次以便在不得不抽出该装置之前在不同位置输送多个锚固组件。另一方面,该摇臂组件包括使用充足的能量加载的一个或多个弹簧组件,以便多次地推进和收回核心组件。输送系统还包括重置组件(resetassembly),该重置组件可以对把手和核心组件内的一个或多个弹簧再加载。可以领会到,摇臂和线轴外壳致动(spool housing actuation)可以通过手动推进、弹性体、压缩空气或电动机完成。
在一个具体方面,本发明涉及一种输送装置,该输送装置完成在患者身体内的第一位置的第一或远端锚固组件部件的输送以及位于患者体内的第二位置的第二或近端锚固组件部件的输送。该装置也完成赋予输送过程中的张力以及移植的锚固部件之间的张力,以及将锚固组件切割到所需的长度并就地组装近端锚固件。该手术可以采用被并入装置中的显示器而被观察。同样,该输送装置的尺寸和形状可以使其与18到24F范围中的护套,优选地为19F的护套兼容。
另外,在多致动触发器锚固输送系统的考虑范围内的实施方式中,第一触发器拉动(trigger pull)引起针组件在患者体内被推进到介入性部位。第二触发器拉动完成锚固组件的第一锚固部件在介入性部位的部署,并且第三触发器拉动促进抽出针组件。第四触发器下压促进锚固组件的第二部件在介入性部位的组装和释放。还提供了重置组件,以重置输送系统的各方面。
本发明也考虑了可逆的手术以及当通过x光线、MRI或其它成像模态超声地观察时具有充足的可视性的锚固组件。一方面,通过切割锚固组件的连接器以及移除锚固组件的锚固件,例如,通过这样移除之前移植在尿道中的邻近地放置的锚固件,移植手术是可逆的。此外,锚固组件可以形成促进超声波观察或其它成像模态的结构。
锚固组件可以被设置成完成收缩、加高、压缩、支撑或复位人体内或动物对象体内的组织。此外,该设备设置成部署锚固组件,并且锚固组件本身被设置成完成匹配身体解剖结构以及与身体解剖结构配合。另外,锚固组件可以被涂覆有治疗性或诊断性物质或被埋置在治疗性或诊断性物质中,特别是肉毒杆菌毒素,或者这些物质可以通过锚固部署装置(anchor deployment device)或其它结构被引导进入或靠近介入性部位。
另一方面,锚固组件的结构被设计成缩入在组织解剖结构内部或匹配组织解剖结构,从而促进痊愈并最小化感染的风险或结石形成的风险。此外,锚固输送装置包括在针组件的延伸位置相对于装置之间形成所需的角度的结构。另外,已考虑,锚固输送装置的远端端部部分被设置成促进定位锚固组件的效率的测试。就这点而言,远端端部部分被设置成允许装置操作者模仿第二锚固构件将在锚固输送之前具有的效果。
在一个实施方式中,锚固输送装置包括把手组件,把手组件带有连接到其的触发器。触发器与把手组件的主体关联,并且被可操作地连接到针组件以及推进第一锚固构件的结构。该触发器也可操作地与完成将第二锚固构件的第一和第二部分组装到彼此以及组装到连接器构件的结构关联,或者通过围绕连接器构件形成单件第二锚固构件。另外,把手组件装备有设置在一个已考虑的实施方式中的结构,以实现将锚固组件切割到所需的长度以及将结构部署在介入性部位。
在一个具体的实施方式中,锚固输送装置包括大致上细长的管状外壳组件构件,该大致上细长的管状外壳组件构件从包括触发器的把手组件远端地延伸。把手组件的近端端部装备有设置成接收望远镜或其它内视镜观察仪器的安装结构。尺寸能接收望远镜的钻孔远端地延伸穿过把手组件的主体,并且继续穿过形成大致上细长构件的外部管状覆盖物组件。被罩在管状外壳组件内的是望远镜管,该望远镜管具有一内部,该内部界定尺寸能接收望远镜的钻孔的远端部分、尺寸能接收第二锚固构件的多个第一部件的上部管状构件组件,以及设置成接收针组件的针外壳。此外,大致上细长的管状外壳包括由突出端组件(nose assembly)界定的终端端部部分,其保持第二锚固构件的多个第二部件。
另外,在一个优选的实施方式中,第一锚固构件包括管状部分、中间部分和尾部部分。构件的尾部部分还包括起到弹簧作用的连接器部分。尾部的终端端部部分还被考虑成具有大于连接器部分的表面区域,以提供用于与组织接合的平台。
此外,在优选的实施方式中,第二锚固构件的一个部件被包含在具有第一远端端部和第二近端端部的销栓中,第一远端端部装备有一对间隔开的臂,第二近端端部包括促进推送性能的沟槽。
此外,也考虑了各种可选择的使用方法。即,在本发明的一些应用中,本发明可以被用于促进体液穿过体腔管的意志的或非意志的流动,改变体腔管或腔的尺寸或形状,治疗前列腺放大,治疗尿失禁,支撑或保持组织、器官或移植物的复位,实施美容的加高或复位手术,形成吻合的连接,和/或治疗各种其它的紊乱,其中自然的或病理学的组织或器官按压在邻近的解剖结构上或干扰邻近的解剖结构。同样,本发明具有许多的其它潜在的外科的、治疗的、美容的或整形的应用,比如在组织、器官、移植物或其它材料要求收回、加高、复位、压缩或支撑的地方。
通过接下来的详细描述结合附图,本发明的其它特征和优势将变得明显,其中附图通过例子说明本发明的原则。
附图说明
图1A为立面图,其描绘了本发明的多致动触发器锚固输送系统;
图1B为立面图,其描绘了移除了把手壳体的图1A的系统;
图1C为转动的立面图,其描绘了不带有把手壳体的图1B的系统;
图1D为详细视图,其描绘了图1C的装置的远端端部部分;
图2A为透视图,其描绘了图1B的多致动触发器锚固输送系统的核心组件;
图2B为透视图,其描绘了图2A的核心组件的轴杆组件;
图2C为透视图,其描绘了形成轴杆组件各部分的另一种方法;
图2D为透视图,其描绘了构造系统的远端端部部分的另一种方法;
图2E为透视图,其描绘了形成轴杆组件的可选择的方法的第一步骤;
图2F为透视图,其描绘了形成轴杆组件的可选择的方法的第二步骤;
图2G为透视图,其描绘了形成轴杆组件的可选择的方法的第三步骤;
图2H为透视图,其描绘了形成轴杆组件的可选择的方法的第四步骤;
图2I为透视图,其描绘了形成轴杆组件的可选择的方法的第五步骤;
图3A为立面图,其描绘了图1B的多致动触发器锚固输送系统的摇臂组件;
图3B为立面图,其描绘了将曲轴弹簧组件移除的图3A的摇臂组件;
图3C为立面图,其描绘了将大曲轴齿轮移除的图3B的摇臂组件;
图3D为立面图,其描绘了将摇臂棘轮移除的图3C的摇臂组件;
图3E为旋转的立面图,其描绘了图3D的摇臂组件;
图3F为等轴测视图,其描绘了曲轴轴承组件和凸轮轴承组件的并列;
图4A为旋转的透视图,其描绘了图1B的多致动触发器锚固输送系统的线轴组件;
图4B为展开视图,其描绘了图4A的线轴组件;
图5A为放大的立面图,其描绘了图1B的多致动触发器锚固输送系统的触发器组件;
图5B为立面图,其描绘了移除了安装块(mounting block)的图5A的触发器组件;
图5C为立面图,其描绘了移除了钟形曲轴的图5B的触发器组件;
图5D为旋转的透视图,其描绘了移除了安装块盖子的图5C的触发器组件;
图5E为放大视图,其描绘了缺省位置中的双棘爪;
图5F为放大视图,其描绘了在触发器下压之后的双棘爪;
图5G为放大视图,其描绘了包括钟形曲轴跟随器的钟形曲轴框架;
图6A为放大的透视图,其描绘了图1C的多致动触发器锚固输送系统的重置组件;
图6B为透视图,其描绘了将重置旋钮和重置单向轮移除的图6A的组件;
图7A为透视图,其描绘了本发明的锚固组件的第一锚固构件的一个优选实施方式;
图7B为侧视图,其描绘了连接到连接构件的图7A的第一锚固构件;
图7C为透视图,其描绘了第二锚固构件的一个优选实施方式的部件在组装前的构造;以及
图7D为透视图,其描绘了连接到连接构件的本发明的组装的第二锚固构件;
图8为横截面视图,其描绘了使用本发明治疗前列腺的第一步骤;
图9A为左侧视图,其描绘了移除了把手左半边和重置组件的图1A的多致动触发器锚固输送系统;
图9B为左侧视图,其描绘了触发器被按压的图9A的组件;
图9C为左侧视图,其描绘了触发器部分地被返回并且移除了摇臂组件的图9A的组件;
图9D为部分横截面图,其描绘了锚固部署装置的远端端部部分以及针组件的横向推进;
图9E为横截面视图,其描绘了使用本发明治疗前列腺的第二步骤;
图10A为左侧视图,其描绘了触发器被致动达第二时间的图9C的组件;
图10B为左侧视图,其描绘了触发器进一步被下压的图10A的组件;
图10C为左侧视图,其描绘了触发器完全被下压的图10B的组件;
图10D为透视图,其描绘了在第一锚固件的部署之后图9D的锚固部署装置的远端端部部分;
图10E为可延伸的尖端的横截面视图,其描绘了图10D的组件;
图10F为横截面视图,其描绘了使用本发明治疗前列腺的方法的另外的步骤;
图11A为左侧视图,其描绘了处于预备位置以便第三次致动的图9A的组件;
图11B为左侧视图,其描绘了触发器被部分地下压的图11A的组件;
图11C为左侧视图,其描绘了触发器被完全地下压的图11B的组件;
图11D为透视图,其描绘了针组件完全收回之后的图9D的组件;
图11E为横截面图,其描绘了使用本发明治疗前列腺的方法的另一个步骤;
图12A为左侧视图,其描绘了处于预备位置以便第四次致动的图9A的组件;
图12B为左侧视图,其描绘了图12A的组件的触发器被下压的中间阶段;
图12C为左侧视图,其描绘了图12B的组件的触发器的完全下压,而凸轮部分转动;
图12D为部分横截面图,其描绘了覆盖物被移除的图9D的组件;
图12E为部分横截面图,其描绘了图12D的部署装置,其中第二锚固构件的第二部件被向着第二锚固构件的第一部件推进;
图12F为左侧视图,其描绘了图12C的组件,其中凸轮完全转动,并且外部管组件向近端拉动;
图12G为透视图,其描绘了输送装置的图9D的组件,其中第二部件完全地被推进成与第一部件和连接器构件切口锁定接合;
图12H为横截面视图,其描绘了涉及使用本发明治疗前列腺的另外的步骤;
图13为左侧视图,其描绘了本发明的多致动触发器锚固输送组件,其中重置机构设置成对系统再加载;
图14A为横截面视图,其描绘了锚固组件在介入性部位的移植;以及
图14B为放大视图,其描绘了图14A中示出的组件的一个锚固部件。
具体实施方式
现在转到附图,这些附图是作为例子来提供的,而不是要进行限制,本发明在于一种设置成将锚固组件输送到患者体内的装置。如陈述的那样,本发明可以被用于各种医疗用途,包括但不限於,对组织、器官、解剖结构、移植物或患者体内发现的其它物质进行收回、加高、压缩、支撑或复位。此种组织操纵旨在促进疾病或紊乱的治疗。此外,公开的本发明在美容或整形用途中或者在涉及医学治疗的部署或研究领域中有应用。
在一个具体方面,本发明的锚固组件被考虑成形成可以被超声波观察到的结构。因此,当医疗专家进行诊断或治疗与比如前列腺癌有关的疾病时,锚固组件可以在超声波身体扫描的过程中比如普通的跨直肠超声波扫描的过程中被观察到。
在这些用途中,锚固组件的一部分贴靠着解剖结构的第一部分定位并移植。锚固组件的第二部分随后为了相对于解剖结构的第一部分而收回、加高、压缩、支撑或复位解剖结构的第二部分的目的,以及为了相对于解剖结构的第二部分而收回、加高、压缩、支撑或复位解剖结构的第一部分的目的而相邻于解剖结构的第二部分定位和移植。也应认识到,锚固组件的第一部分和第二部分均可以被设置成完成解剖结构所需的由于经由附加到锚固组件的第一部分和第二部分的连接器组件对其提供的张力而产生的收回、加高、压缩、支撑或复位。
现在参照图1A-D,其示出了本发明的多致动触发器锚固输送系统100的一个实施方式。此装置被设置成包括能够通向介入性部位以及在患者体内组装和移植一个或多个锚固组件的结构。在一个方面,装置100被设置成组装和移植四个锚固组件。该装置还被考虑为可兼容的,以便和19F护套一起使用。该装置此外还包括设置成接收常规远程观察装置(如,内窥镜)的结构,以便在介入性部位实施的各步骤可以被观察到。
多致动触发器锚固输送装置100包括连接到细长的组织通道组件104的把手组件102。细长的组织通道组件104罩住用于构造多个锚固组件的部件。
锚固输送系统100还包括多个子组件。把手壳体组件106包括配合把手半片,这些配合把手半片包住把手组件102。把手组件102的尺寸和形状使其能够舒适地配合在操作者手中,并且其可以由常规材料形成。窗107可以被形成在把手壳体组件106中,以便提供通向装置内部机构的通道,从而在介入性手术需要被放弃时,操作者可以进行手动控制(manual override)。核心组件110延伸穿过把手组件102,并且包括界定细长组织通道组件104的部件。
把手组件102还包括触发器系统组件114、线轴组件116以及摇臂组件118。这些组件相配合,以实现通向介入性部位以及锚固组件在介入性部位的组装和移植。
此外,锚固输送系统的终端端部部分119包括成形为提供无创伤表面的远端尖端组件128以及促进锚固组件的部件的所需的定位的一个表面(见图1D)。即,通过包括能够模仿锚固组件的邻近地定向的部件的最终位置的结构,操作者可以在移植之前测试锚固组件的效果。一旦操作者确认对象锚固部件(subject anchor component)将根据需要被定位,则锚固件的移植随后被进行并完成。
现在转到图2A-2B,示出了核心组件110。如陈述的那样,核心组件110保持必要的用来组装多个锚固组件的部件。核心组件110包括轴杆组件120、棘轮块组件(ratchet block assembly)122、外部覆盖物块组件(outer cover block assembly)124、停止组件126以及远端尖端组件128。在一个实施方式中,核心组件110恒定地连接到把手组件102。在一个可选择的实施方式中,核心组件被暂时地连接到把手组件,以允许把手组件的重新使用以及核心组件的处理。
具体地参照图2B,轴杆组件120还包括细长内窥镜管130,该内窥镜管130从镜后部安装件132延伸穿过前部板组件134,并远端地延伸到轴杆组件120的终端端部136。内窥镜管容纳可移除的内窥镜。另外,从前部板组件134远端地延伸并布置成大致上平行于内窥镜管130的是推动器管组件138,该推动器管组件138包括用于在管内保持锚固部件对准的锚固对准管。设置成接收针组件的另一细长的管状外壳140也从前部板组件134纵向地延伸。该前部板组件还包括护套密封板143,该护套密封板143被设置成在延伸穿过其中的细长部件之间以及之中产生密封(见图2A)。
在一种可选择的方法中(见图2C-D),有可能使得轴杆组件120被构造成具有匹配的凸出的半片146,以便等同于电流三腔管(currenttrilumen)轴杆组件那样起作用。
另外,远端尖端组件128可以被集成到细长轴杆的一个半片。半片196中的一个或两个将具有细长通道147,该细长通道147可以是半圆形的甚至是方形共享的,但是将功能性地将望远镜和针组件约束并罩住在它们独特的通道中。在一种简单构造中,第二个半片可以仅仅关闭开放通道147以便约束望远镜和针组件。
引导针尖穿过尿道壁(或其它身体腔管)的远端弯曲的针外壳148被集成到半片中的一个或两个,这里,如果其被偏置到一个半片,则引导表面可以提供更紧密的接触以及改进的性能。
销栓储存管149可以为镍钛合金管或不锈钢管,其带有激光切割或激光焊接的组装特征部或者同时带有激光切割和激光焊接的组装特征部。这些组装特征部可以被折叠在凸出部分或可以被俘获在轴杆凸出组件之间的点的上方,因此将各部分集成,以便用较低的复杂度或成本在功能性上像本发明一样起作用。
在另外一种方法中,轴杆组件120的可选择的构造可以包括冲压的金属元件,该冲压的金属元件为单独的具有薄壁的不锈钢细长条状物151(见图2E-I)。小窗形(fenetration)、城堡形(castellation)或凸出物153(图2F)可以围绕边缘被冲压,以便被成型155(图2G和2H)以保持下面的管(hypotube)在不同的点彼此靠近,这些下面的管可以稍后被插入模塑在简单塑料注射模具壳159上面或者被插入简单塑料注射模具壳159(图21)。和单个塑料轴杆组件相比,金属形成的插入件将在组件中提供更多结构刚度以及精度。因此,形成的条状物可以看起来像是在局部地形成的条状物的相反方向中形成的带有间歇性凸出部分的波图案,引起多个同轴的连接路径,下面的管可以被组装穿过这些连接路径并被固定就位。
在一个具体方面,核心组件120还装备有引导轨145,该引导轨145对组件提供结构支撑以及引导件,各种子组件在被触发器组件致动的情况下沿着引导件平移。同样,核心组件120包括可纵向平移的外部管组件142(见图2A),该可纵向平移的外部管组件142的远端端部被接纳在远端尖端组件128内(同样见图1D)。如下文更详细的描绘的那样,远端尖端组件罩住多个环或圆柱以及弹簧偏置的进料器(feeder)。
参照图3A-E,把手组件的摇臂组件118被描述成与触发器系统组件114相互作用。该摇臂组件与多致动触发器组件相互作用,以便将每次单独的触发器拉动转换成锚固输送系统100的四个不同的动作。
现在具体地参照图3D和图3E,应理解,摇臂组件118在两点,即在摇臂枢轴点173和在曲轴轴杆172被磨光。这些元件都可自由转动,但不能平移。组件118的中间部分以止转器轭结构(scotch yokestructure)为特征。如通常知道的那样,可以应用止转器轭以便将转动运动转换成线性运动。这里,摇臂组件118是由弹簧组件162提供动力的,并且通过触发器组件114和摇动棘爪163之间的相互作用,此弹簧组件162选择性地被致动以产生曲轴轴承组件176的转动,该曲轴轴承组件176在偏离中心的位置连接到凸轮轴承组件180。这进而引起凸轮轴承180沿着由卵形凹处178界定的障碍物被引导,该卵形凹处178形成在摇臂组件118的下部摇臂部分152中。此动作引起摇臂组件118在其下部端部围绕摇动枢轴点173枢轴转动,并在其顶部端部引起线性运动。此线性运动被用来选择性地纵向地平移线轴组件116。
在一个具体方面,摇臂组件118包括上部摇臂组件150、下部摇臂组件152以及上部断开连接件154和下部断开连接件156。上部摇臂150的终端端部157被设置有槽,该槽可滑动地与线轴组件116上的互补结构接合,该槽和互补结构的互相连接促进摇臂组件的关节运动(articulating movement)转化成线轴组件116的纵向运动。另外,弹簧(未示出)将上部摇臂组件150连接到上部断开连接件154。阻尼器组件166以速度调制模式运行,该速度调制模式支配大齿轮164的动作,并因此支配摇臂组件118响应于触发器组件114的动作。阻尼器组件166被填充有具有已知粘度的选定量的流体。该流体的量和粘度可以变化以达到所需的阻尼效果。在考虑的方法中,下部摇臂组件152包括一对间隔开的枢轴点158、160,上部摇臂150和下部断开连接件156被枢轴转动地连接到该对间隔开的枢轴点158、160。另外,在上部断开连接件154和下部断开连接件156之间存在有枢轴连接。摇臂组件还包括安装在下部摇臂组件152上的曲轴弹簧组件162。
随着曲轴弹簧组件162被移除(见图3B),大齿轮164和一对间隔开的阻尼组件166之间的接合可以更好地被实现。设置在下部摇臂组件152的相同侧面并相邻于大齿轮164的是摇臂棘轮168(见图3C)。曲轴机轴(crank arbor)170被定位在摇臂棘轮168的外部表面上。应认识到,由于触发器组件的致动,曲轴弹簧组件162逆时针驱动曲轴170,并从而关于摇臂枢轴点173向前和向后移动摇臂组件118。
摇臂棘轮168和曲轴机轴170中的每一个(见图3C)被设置成位于被设置在中间的曲轴轴杆172上,曲轴轴杆穿过形成在下部摇臂152中的弯曲的槽174(见图3D)。在下部摇臂组件52的相对侧面并且也被安装在曲轴轴杆172上的是偏心地布置的曲轴轴承组件176(见图3E)。同样见图3F,其描绘了曲轴轴承组件176和凸轮轴承组件180的并列。
此外,如陈述的那样,设置在曲轴轴承176的一部分上并且位于形成在下部摇臂152中的卵形凹处178内部的是凸轮轴承180。曲轴轴承176被转动地耦合到曲轴轴杆172,并从而作为止转器轭在上部摇臂150的终端端部157将转动运动转换成线性运动。另外,在操作中,曲轴弹簧组件162被避免由弹簧加载的摇动棘爪163卸载(见图3C),该摇动棘爪在触发器致动的某些阶段中是脱扣的。在这点上,该组件被装备有防跳元件(no-skip feature)。即,如图3C中最佳地见到的那样,摇臂棘轮168被装备有防跳凸轮表面175。随着触发器组件引起摇动棘爪163的一端从摇臂棘轮168分离以及摇臂棘轮168响应于由曲轴弹簧组件提供的能量而转动,防跳连接件凸轮跟随器177与防跳凸轮表面175接合。此动作引起恰当地定位各部件,以便由于在跳动之后棘爪163的高曲轴速度和低反应速度而防止棘爪跳动以及使针部署加倍。扭力弹簧179被提供在竖直地定位的枢轴点158,以防止下部摇臂152中的高速度以帮助控制摇臂棘轮168的转动速度。如可以从各附图中见到的那样,摇臂棘轮168仅包括两个齿,这两个齿轮流地被摇臂棘爪组件163接合。这些齿被间隔开,以便推进冲程发生在一个棘爪尖端,而收回冲程发生在下一个棘爪尖端。
另外,在触发器组件致动的阶段中,当终端端部159击中停止组件126并且有下部摇臂组件152的转动时,上部断开连接件154和下部断开连接件156由于该两构件之间的枢轴点向内朝着上部摇臂组件150平移而断开。此断开动作允许下部摇臂152在整个冲程中继续,同时上部断开连接件摇臂154在相反方向转动,以便进一步的平移没有被赋予到终端端部157上,线轴组件116以及连接到线轴组件116的针组件停止在由停止组件126设置的深度。因此,此机构像下文更全面地描述的那样控制线轴组件的运动。
最后,形成在把手106中的窗107也可以被用于接近摇臂组件118的各部分,或者把手壳体106本身可以被移除以便这样做。因此,曲轴轴承组件176可以被手动地转动,以便完成各部件转动摇臂组件的所需的运动。因此,对其提供抽释元件(bailout feature),以便例如收回针组件。
现在转到图4A和图4B,其示出了线轴组件190。该线轴组件被用于从锚固输送装置的远端端部推动锚固部件。该旋转机构的特别优势在于,其允许带有大约6cm(对应于线轴的周长的1/2)的连接器材料比如0.015英寸直径的单丝PET(monofilament PET)的若干个(例如四个)锚固组件在锚固件之间被储存在配合在用户手中相对地小的装置中。线轴组件190还包括张力外壳组件192、部署外壳组件194以及阻尼组件196。
张力外壳组件192被设置在外壳盖子198和部署外壳组件194之间。线轴组件190还包括张力外壳201中的环形凹处200,其尺寸和形状能接收带有张力弹簧的张力机轴。在一种方法中,一旦部件已经被部署,则该张力弹簧对移植部件施加一磅的张力,但是可以根据需要提供更少和更多的张力。另外,该组件被设置成使得在移植之前没有张力被施加。同样,随着针被收回,张力弹簧204被加载直到1/2转,从而张紧该缝线,并随后其卸载,从而在尿道锚固件被输送并且缝线被切割之后收回胶囊状的锚固组件。外壳盖子198将张力机轴202和张力弹簧204保持在环形凹处200内。此外,线轴外壳190还可以包括衬套206,该衬套206配合在通过一对间隔开的臂209形成的孔208内,该对间隔开的臂209从张力外壳组件192的顶部延伸。衬套206提供用于沿着核心组件110的轨道140平滑移动的表面(见图2A)。
如图4B中示出的那样,部署外壳组件194被设置成带有面向张力外壳组件192的第一圆形凹处208。该第一凹处208的尺寸和形状使其接收带有中心轴杆230的线轴组件。邻近地布置的张力外壳组件192将线轴组件210保持在第一凹处208内。应理解,线材(未示出)被围绕线轴组件210围绕。该线材被捆绑到移植物(锚固件)组件,并且在锚固组件的部署过程中将驱动力和张紧扭矩从线轴组件190传递到移植部件。第二凹处(未示出)被形成在部署外壳组件194的面向阻尼器组件196的相反侧面。此第二圆形凹处的尺寸和形状使其接收线轴棘轮圆盘214,该线轴棘轮圆盘214夹在带有中心轴杆216的部署机轴和缝线部署弹簧218之间,该缝线部署弹簧218初始地被完全加载有足够的能量,以便驱动四个远端锚固构件离开针。阻尼组件196将线轴棘轮圆盘214、部署机轴216以及缝线部署弹簧218保持在部署外壳组件194的第二凹处内。该部署外壳组件190还被装备有弹簧加载的缝线部署棘爪组件219,该缝线部署棘爪组件219被接纳在形成在外壳194的底部横向表面的凹处内。应注意到,线轴棘轮圆盘214以使得部署弹簧(未示出)被抑制卸载直到部署棘爪219被脱扣的方式被耦合到部署机轴216。如果主要机构移动得比棘爪219的响应时间更快,则这里防跳机构再次防止加倍部署(doubledeployment)。
阻尼组件196包括阻尼主体224和具有多个交织的圆形表面的阻尼转子220,以使阻尼转子220可以在阻尼主体224内转动。交织的表面之间的间距被填充有粘性阻尼流体(未示出)。阻尼转子220具有方形栓钉,该方形栓钉强制地以及恒定地接合进入部署机轴216的方形端口,从而在部署弹簧218被卸载时对部署弹簧218提供速度调制,以便部署远端锚固构件离开针。
中心轴杆230被设置成穿过张力外壳组件192,并延伸到部署外壳组件194内部。轴杆230的方形截面231总是通过部署机轴216或张力机轴202被接合在线轴组件190中。因此,当部署棘爪219被释放时,中心轴杆230的方形截面与部署机轴216接合,并且与张力机轴202分离。这允许部署弹簧180度地驱动线轴210。抛出臂组件(throwout arm assembly)232被保持在中心轴杆230上,并且包括分叉的子结构234,该分叉的子结构234设置成接合触发器组件114的互补结构。抛出臂组件被触发器组件致动,以便在输送过程中在所需的时间点在部署机轴216和张力机轴202之间平移轴杆230。
形成在把手壳体组件106中的窗107(见图1A)可以被设置成在任何部件变得卡住的情况中提供通向线轴组件190的部件的便利的直接通道。例如,力可以直接地被施加到抛出臂232,以便组件的穿梭动作可以被促进。
现在参照图5A-E,其描述了触发器系统组件114的各部件。触发器组件114包括触发器齿条组件240、触发器凸轮组件242、下部凸轮组件244以及钟形曲轴组件246,这些组件中的每一个连接或分离地与安装块组件248关联。还提供了棘爪组件249以便交替地接合下部凸轮组件。也设置有销栓驱动后部连接件250,并且其被枢轴转动地连接到下部凸轮组件244。为了容易理解各种部件的相对定位,安装块组件248已经被从图5B和图5C描绘的结构移除,并且钟形曲轴组件246已经被从图5C移除。
触发器齿条组件240包括从触发器254延伸的机械齿条252,该机械齿条252的尺寸和形状使其接收操作者的手的一部分。同样从触发器254延伸的是相位销子(phasing dowel)256,该相位销子256被设置成限制触发器254的下压。触发器齿条组件240还包括弹簧258,以便偏置组件使其从安装块组件248离开。
触发器齿条组件240的齿条252与触发器凸轮组件242接合。触发器凸轮组件242还包括带有与齿条252的齿匹配的齿的触发器小齿轮259(见图5D)。触发器小齿轮259被放置成邻近于凸轮子组件260,触发器小齿轮259和凸轮子组件260中的每一个被放置在中心触发器轴杆262上。
下部凸轮组件244包括连接件264,该连接件264的一端行进穿过形成在下部凸轮板266中的开放的V形槽。同样形成于下部凸轮板266中的是用于接收重置组件(下文中结合图6A和图6B描述)的轴杆的贯通孔267。连接件264的相对的端部被设置成在形成在销栓驱动后部连接件250内的槽269内滑动。销栓驱动后部连接件250的顶端部268可操作地与用于推进锚固组件的部件穿过核心组件120的结构关联。
钟形曲轴组件246包括T形框架270,位于该T形框架270顶部的是一对间隔开的臂272(图5A)。设置在臂之间的是钟形曲轴轨道274。在该结构的背面设置有钟形曲轴跟随器275(见图5G)。
如图5D中最佳地见到的那样,在安装块覆盖物276被移除的情况下,触发器组件114还包括部署板组件280。此组件包括部署板282,枢轴转动地连接到该部署板282的是第一连接件284以及第二连接件286。还提供了双棘爪组件288,双棘爪组件288的操作由安装到触发器齿条242的止轮垫致动器(sprag actuator)290控制。
双棘爪组件288被设置成起到触发器控制机构的作用。在第一缺省位置中,该双棘爪组件288与齿条组件240以允许触发器254被下压同时允许和保持部分下压并防止不完全下压(见图5E)的方式接合。一旦触发器254被完全地下压,止轮垫致动器290与双棘爪组件接合,从而引起其转动以使齿条组件240和双棘爪组件288之间的缺省接合被消除(见图5F)。随后,齿条组件240可以经由偏置弹簧258返回到其初始位置(见图5D)。随着齿条组件240和双棘爪组件288的缺省接合被消除,第二可选择的接合被产生。在第二接合中,双棘爪组件允许触发器254和齿条组件240返回到初始位置,并防止不完全返回到初始位置。即双棘爪组件双向地控制触发器冲程。因此,双棘爪组件288和止轮垫致动器290之间的接合随后限制触发器可以被下压的程度,并促进触发器254返回到其缺省位置或未下压位置。
因此,单触发器254经过与摇动棘爪组件163和抛出臂组件232的操作关联来致动部署的所有步骤。即,触发器254的致动引起钟形曲轴组件270横向地枢轴转动,同时也带动了抛出臂组件232。通过连接到中心轴杆230,抛出臂完成轴杆230在由线轴组件190实施的功能之间的穿梭。此外,触发器254的致动还完成摇动棘爪163和曲轴机轴170之间可选择的接合以及分离。此接合和分离允许线轴组件190在前位置和后位置之间的纵向运动。随着针组件和推动器组件可操作地连接到该安装件,此纵向运动类似地受到触发器254致动控制。
另外的触发器控制是由相位销子256和触发器凸轮子组件260之间的相互作用提供的。即,触发器凸轮260包括形成在其周边中的多个槽291。这些槽291接收相位销子256的终端端部,以便触发器凸轮260响应于触发器下压的连续转动被这些零件之间的接合所抑制。设置在触发器凸轮260内的滚柱离合器(roller clutch)(未示出)通过除了在向内触发器冲程的过程中以外抑制凸轮260移动来提供另外的控制。
把手壳体106中的窗107(图1A)还可以被设置成提供通向触发器组件114的部件的通道。即,双棘爪组件388可以被手动地接合,例如,以便从而控制卡住(jam)。类似地,组件114的其它部件可以被接合成以便促进恰当地运行。
把手组件102还包括重置组件300(见图1C和6A-B),以便在部署和移植锚固组件之后重置输送系统,以便预备部署另一锚固组件。该重置组件300包括可转动地安装到重置板303的重置旋钮302,并且具有设置成接收接合弹簧304的内部。还提供了操纵杆305以便容易操纵组件。同样,提供了一对轴承306、308,以便与重置旋钮302匹配,并提供用于与横向地延伸穿过触发器组件114的孔267的轴杆309接合的表面。旋钮闩310被设置成可释放地与旋钮302接合。
重置组件300也包括安装到重置板303的单向重置轮子组件312,重置连接件314可转动地连接到该重置板303。重置轮子组件312防止轴杆的向后运动,直到重置动作被完成。重置动作重新加载弹簧304,该弹簧304为尿道凸轮244提供动力(图5D)。靠近重置连接件314的相对的终端端部的是带螺纹的凸出件316,该带螺纹的凸出件316适合于与旋钮302的互补结构接合(见图6B)。重置组件300也包括被设置成共心地位于重置轴承322内部的单向重置离合器320。同样包含在重置组件内部的是U形重置线材型模(wire form)324。提供有缓冲器326,以便偏转U形线材型模324,U形线材型模324作用在缓冲器326上,以便推动单向重置轮子312离开上止点(topdead center)位置以及下止点位置,在上止点位置和下止点位置,连接件314不能转动轮子312。
在上面的描述中,弹簧已经被描述为用于在触发器被拉动时致动各个组件的机构,然而,使用其它机构比如电动机、压缩气体、弹性体以及类似物也在本发明的范围内。
图7A-D中描述了本发明的锚固组件的一个优选的实施方式。在其无约束构造中,第一或远端锚固部件370包括第一管状部分372,该第一管状部分372大致上正交于第二尾部部分374。然而,应注意到,被罩在输送组件中并且在部署在目标区域之前时,第一锚固部件370被约束,以界定大致上笔直的构造,随后仅在从输送装置部署时采取无约束构造。
第一锚固部件370的管状部分372包括多个凸出部分376,这些凸出部分376可以被变形或偏转以完成将部件370附加到连接器组件378(见图7B)。已经发现,三个这样的凸出部分376,两个在管状部分372的侧面以及一个在相对的侧面,提供充分的连接力以及连接器378和第一锚固部件370之间所需的平衡,并通过在近端方向或远端方向施加力来移动第一锚固部件370。
已考虑到,第一锚固部件370可以为由镍钛合金或其它合适的材料形成的管激光切割的。部件370的中间部分380提供从管状部分372到尾部部分374的结构过渡。因此,在中间部分区域380,侧壁的一部分被移除。侧壁另外的部分被移除以界定尾部374的连接部分382,其从中间部分380延伸。此连接器部分382起到弹簧的作用,以完成尾部374和管状部分372之间采取的相对无约束的角度。尾部374的终端端部部分383包含其表面面积大于连接器部分382的表面面积的结构,以便从而提供用于接合位于目标部位的组织的实质上的平台。
如图7C和图D中示出的那样,第二锚固部件384包括第一部分386和第二部分388。一旦第一锚固部件370通过采用输送装置比如下文(或前文)公开的输送装置被定位在目标部位,则第二锚固部件384被就地组装。
第二锚固部件384的第一部分386包括内部钻孔390,该内部钻孔390的尺寸形成为使其能接收处于锁定接合中的第二锚固部件384的第二部分388的一部分。第一部分386的外部表面的尺寸和形状形成为使其包括与中间部分392间隔开的近端轴衬391,中间部分392和近端轴衬391各自具有大致上圆柱形的轮廓。较小直径的外部圆柱部分393被设置在近端轴衬391和部件的中间部分392之间,且具有更小的圆柱形轮廓的远端圆柱形部分394界定其远端端部。
第二锚固部件384的第二部分388包括实心的大致上圆柱形的后端部395,从该后端部395延伸的是一对间隔开的叉形物396。叉形物396的终端端部可以是有锥度的,以便促进叉形物396插入在第一部分386的内部钻孔390内,以及接收连接器组件378的一部分。显著地,叉形物结构开始于收窄的槽397,该槽397向外进阶到更宽的尺度,以便从而界定叉形物396之间的空间。此收窄的槽397提供具有所需的结构刚度的第二部分388,以便接收连接器组件378以及促进锁定地接合第一部分386和第二部分388之间的连接。在一个实施方式中,叉形物396之间的空间的尺度可以关于连接器378的直径,以便其具有充分的夹持力,从而不需要第一部分386,并因此为任选的以便提供附加的安全性。
因此,在其预先移植的形式中,锚固组件可以包括一个锚固构件(例如第一锚固件),该锚固构件的带有连接器的初始接合为大致上同轴的,并且带有初始接合的另一锚固构件(例如第二锚固件)为大致上与连接器垂直的。
这些组件还可以被用来将治疗性或诊断性物质输送到介入性部位。例如,在治疗前列腺的手术中,引起前列腺尺寸减小的物质比如5-α-还原酶抑制剂可以在治疗部位被引入。有特定优势的手术是,使用锚固输送装置的针,以在部署锚固组件之前、之中或之后注射溶解在4毫升的盐水中的100到200单位的肉毒杆菌毒素(比如可以从Allergan,Inc得到的肉毒杆菌毒素)。优选地,每叶前列腺被注入2毫升。另一个有优势的手术是,使用锚固输送装置的针,将溶解在10到30毫升的盐水中的100到300单位的肉毒杆菌毒素注射进入膀胱的基部、膀胱侧壁和/或膀胱三角区。优选地,0.5到1.0毫升被注射进入膀胱中的大约20到30个部位,以便治疗过度活跃的膀胱。可以在该部位被引入的其它物质包括但不限於各种疤痕剂、拉帕霉素(rapamycin)以及其类似物和衍生物、紫杉醇(paclitaxel)以及其类似物和衍生物、植物化学物质、α-1a-肾上腺素受体阻断剂、平滑肌弛缓剂以及抑制睾丸素到二氢睾酮的转换的其它药剂。
在为了操纵组织或其它解剖结构的用途的输送和部署锚固组件的第一步骤中,内窥镜装置被用于观察多致动触发器锚固输送装置100在介入性部位的定位,例如,该装置的细长组织通道组件104被插入患者的阴茎,并被推进直到远端端部128邻近于邻近膀胱的尿道(UT)中的介入性部位(UB;见图8)。已经发现,和基于能量的解决方案相比,对于治疗BPH的机械解决方案比如本发明的解决方案可以与从前列腺癌恢复的患者更兼容。此外,本发明也考虑用于调整解剖结构大小的步骤。由于其涉及BPH治疗,本发明也涉及超声波装置或其它装置在患者体内比如直肠中的放置,以便测量针组件的远端端部在患者体内的必要的插入深度。此信息可以被用于通过操作者使用在连接到停止组件126的把手外侧上的旋钮(未示出)来设置或产生用于针组件的深度停止装置,以便在部署的过程中,针组件的远端端部从尿道内部一直延伸穿过前列腺到达前列腺囊的外部。
在这样将部署装置定位在患者体内之后,多致动触发器锚固输送装置100被用于组装和移植位于介入性部位的锚固组件。在第一步骤中,触发器组件114的触发器254被下压,直到经过触发器凸轮子组件260通过其与摇臂组件118的互相连接,摇动棘爪跟随器163被从与摇臂棘轮168的锁定接合释放(见图9A)。释放摇臂棘轮168引起曲轴弹簧组件162的卸载,从而引起偏心曲轴176的转动,以及从而引起摇臂组件118的转动以及摇臂组件118和线轴组件116的上部部分的向前平移(见图9B)。这是通过上部摇臂组件150、下部摇臂组件152以及上部断开连接件154和下部断开连接件156以及深度停止组件410的相互作用而被允许的(同样见图2A和3A)。即,深度停止组件410与上部断开连接件154接合,以便其关于下部连接件156断开(或转动),以限制线轴组件的向前运动。此动作经过其与线轴组件116的连接完成针组件400在细长管状外壳140内的推进(见图9D)。此外,深度停止组件410可以根据需要被定位,以便控制针组件400被伸出的深度。选定的位置可以基于由各种成像技术比如超声波成像技术进行的解剖测量。
触发器254的释放允许触发器114返回到预备位置,使线轴组件116处在其向前位置(见图9C)。双棘爪组件288从其缺省位置的联接(同样见图5D)促进触发器组件114这样返回到预备位置。在患者的解剖结构内,针组件400的推进因此引起针穿过前列腺(PG)(见图9E)。在一种考虑的方法中,针400的终端端部被定位,以便延伸到前列腺(PG)以外,但应认识到,针插入的程度可以为了特定的目的而被修改。
接下来,触发器组件114再次被采用以产生远端锚固部件370的部署(见图10A-F)。由于线轴组件外壳116处于向前位置,触发器254的第一半拉动(图10A)引起线轴轴杆230移动到线轴组件190的部署侧面194(图10A和4A-B)。这是经由与驱动抛出臂组件232(同样见4A-B)的钟形曲轴组件246(同样见图5A)的配合完成的。更具体地,随着触发器254的下压,触发器凸轮260转动。连接到钟形曲轴框架270的钟形曲轴跟随器275(见图5G)沿着形成在转动的触发器凸轮260的侧面上的可变的表面行进,表面的变化性引起钟形曲轴框架270从线轴组件外壳116在所需的接合点枢轴转动离开。这引起钟形曲轴框架270使抛出臂组件232枢轴转动,这进而推进线轴轴杆230到达线轴组件190的部署侧面。
随着触发器254继续被下压(图10B),触发器组件114的部署板280(同样见图5D)被定位在升起构造中。此升起的位置起因于部署板推杆(未示出)的竖直运动,该部署板推杆在一端沿着触发器凸轮260的周边行进,而在另一端与部署板280接合。随着推杆接合在触发器凸轮260的周边的升起的部分上,该杆被竖直地平移,这引起部署板280升起。由于被这样定位,部署板组件280致动缝线部署棘爪组件219(同样见图4A-B),这进而允许部署弹簧218的释放以及经由部署弹簧218的线轴轴杆230引起的耦合的转动,并且线轴组件210从而从输送系统100推进缝线。双齿的线轴部署棘轮214在与缝线部署棘爪组件219重新接合以及阻止缝线推进之前允许线轴组件210转半圈。在此结束时,第二触发器254拉动部署板组件280,并且部署棘爪组件219回到其缺省位置(图10C)。
在多致动触发器锚固输送系统100的远端端部128,此动作促进连接到连接器378的第一或远端锚固部件370被推进离开针组件400(见图10D)。如图10E中所示,线材组件402通过恒定连接比如带有粘合剂的聚酰亚胺管与连接器378接合。通过其与张力外壳组件192(同样见图4A-B)的线轴组件210的互相连接,所需的长度的连接器378被付出。应认识到,图10E中的线材组件402已经为了说明性目的被示出,因为其在针组件400内的实际位置在装置使用的此阶段可以更远。大约为针组件400的内直径40%或更大的连接器直径有利于付出连接器378,以防止连接器材料的扭结。该连接器优选地为大约0.015英寸直径的PET单丝。此外,在此阶段,没有张力通过张力外壳组件192被提供到连接器378和第一锚固部件370。
因此,如图10F中所示,第一锚固部件370被从针外壳弹出到前列腺(PG)的外部表面以外。当然,当合适的时候,第一锚固部件370可以用外科方法被放置在前列腺(PG)内,或者在其它手术中被放置在患者体内的任何位置。
现在参照图11A-E,多致动触发器锚固输送系统100被操作以将针组件400从介入性部位抽出。如图11A中所示,在第一锚固部件从针组件400被弹出之后,触发器254再次返回到预备位置。随着第三触发器254拉动(图11B)的开始,中心轴杆230穿梭回到线轴组件116的张力侧面192(同样见图4A-B)。再者,钟形曲轴组件246和抛出臂组件232的配合促进中心轴杆230的穿梭。再次通过加高摇动棘爪163和释放曲轴弹簧组件162,触发器254的另外的下压引起线轴组件116和摇臂组件118返回到缺省位置。因此,被连接到线轴组件116的针组件(未示出)在针管状外壳140内被完全地抽出(见图11D)。因此,第一锚固部件370在介入性部位被加高,同时连接器组件378近端地在细长组织通道组件104内延伸(图11E)。在此接合过程中,所需的张力通过线轴组件外壳116的张力外壳组件192被放置在连接器378以及第一锚固部件370上。此外,张力组件192允许附加的缝线相对于收回的线轴组件116被付出。缝线付出和张力弹簧的功能的此种组合促进定制长度、固定载荷的移植的输送。
再者,随着触发器254自动地返回到预备位置(见图12A),移植手术的下一个步骤可以被完成。即,随着触发器254被下压达第四次(图12B),触发器组件114的棘爪组件249从与触发器组件114的下部凸轮组件244的锁定接合被释放(同样见图5A)。触发器254的完全下压(图12C)随后通过下部凸轮组件244的下部凸轮板266产生轴杆264的水平驱动(同样见图5C)。因此,销栓驱动后部连接件250被向前平移,并且通过其连接到棘轮块组件122(同样见图2A),放置成与第二锚固部件的最后部第二部分388并置的推动器组件(未示出)也被向前推进。
不考虑锚固组件的具体形式,前列腺治疗的情况中的下一个步骤涉及将近端锚固组件定位在例如患者尿道的所需的部分内。在这样做之前,患者可以被监测以确定是否存在有通过锚固件的放置的改进的任何证据。一种这样的症状是是否存在有任何排尿。在这样检查后,近端锚固组件可以被移植。
因此,如图12D和12E中所示,通过推动器组件,第二锚固部件的第二部分388被推动到与锚固组件的连接器378接合。第二部分388随后被推动到与第二锚固件(图12G)的第一部分386接合。在此接合点,外部管组件(未示出)被近端地拉动以便切割连接器378(见图12G),并将组装的第二锚固组件从多致动触发器锚固输送系统100的远端端部128释放。通过外部管连接件420和下部凸轮组件244的配合,外部管组件的近端运动被完成。即,随着下部凸轮组件244向前转动,其凸起的表面与外部管连接件420接合并在相反的方向转动外部管连接件420。通过其连接到外部管组件,外部管连接件420向后驱动外部管组件。
如图12H中所示,组装的锚固组件被放置成跨过前列腺(PG),同时第一锚固部件370设置成贴靠着前列腺(PG)的外部表面,并且第二锚固部件384移植在尿道(UT)内。再者,应认识到,锚固组件可以在患者的解剖结构各处被放置成其它定向。
最后,重置组件300的操纵杆305被致动以重置系统,以便组装和移植另一第二锚固部件384。即,操纵杆300被拉回,以便重新加载重置组件300的弹簧304,从而将所有的组件返回到正确位置以便完成第二锚固部件384的组装和释放。此外,应认识到,输送锚固组件的其它部件中涉及的步骤和机构是通过预加载的能量起作用的,以便所需的数量(例如4个)的这样的部件可以被移植。
因此,本发明考虑了直接推动到锚固组件的锚固部分上,以及直接推动到锚固组件的连接器上。此外,如上文陈述的那样,远端或第一锚固部件通过针组件被推进和部署,并且近端或第二锚固部件的至少一个部件通过锚固部署装置的大致上管状部分被推进和部署。另外,单锚固组件或多锚固组件都可以在介入性部位通过部署装置来输送和部署。因此,在前列腺治疗的情境中,本发明完成前列腺的压缩和前列腺尿道的打开、移植物在介入性部位的输送以及在移植物的端部之间施加张力。此外,药物输送被理解和描述为BPH疗法和治疗过度活跃的膀胱中的另一种疗法。
一旦被移植,本发明的锚固组件(见图14A和14B)完成所需的组织操纵、压缩或收回以及与目标解剖结构的配合,以提供无创伤支撑结构。具体地,锚固组件500的形状和轮廓可以被设置成使得该组件通过尿道腔管被锚固组件打开而收进在目标组织比如形成在尿道中的自然折痕内。实际上,在锚固组件被恰当地放置的情形中,该区域中纤细的或柔软的组织围绕锚固结构折叠。最终,久而久之,自然组织可以生长到锚固组件500上面,并且新细胞生长发生。与目标组织的此种配合促进痊愈,并避免不所需的副作用比如介入性部位的钙化或感染。
此外,除了与自然组织解剖结构配合的意图之外,本发明也考虑加速痊愈或减小疤痕的方法。痊愈可以被改进的方式可以包括采用研磨性材料、有纹理的连接器、生物以及药物。
已经观察到,将锚固件放置在解剖结构内各种所需的位置可以得出最好的结果。例如,当治疗前列腺时,锚固件的一部分可以被放置在尿道内。已经发现,设置这样的锚固件以便10点位置和2点位置(当沿着尿道的轴线看时)被支撑或保持,有效地保持解剖结构开放,并也可以促进锚固部分收进在自然组织内。这在靠近膀胱的解剖结构以及射精管连接到尿道的接合点区域中是特别真实的。
另外,已考虑到,锚固组件的所有部件或其选定的部分(描述的或考虑的锚固组件的任何部分),可以被涂覆有治疗性或诊断性物质(例如药物或治疗性药剂)或埋置在治疗性或诊断性物质中。再者,在治疗前列腺的情境中,锚固组件可以被涂覆有物质或埋置在物质中比如5-α-还原酶,该5-α-还原酶引起前列腺尺寸减小。考虑的其它物质包括但不限於一般的植物化学物质、α-1a-肾上腺素受体阻断剂、平滑肌弛缓剂以及抑制睾丸素到二氢睾酮的转换的药剂。在一种特定的方法中,连接器95可以例如被涂覆有聚合物基质或凝胶涂层,该聚合物基质或凝胶涂层保持治疗性或诊断性物质,并促进完成其定时的释放。此外,考虑了,抑菌的涂层可以被施加到本文描述的锚固组件的各个部分。这些涂层可以具有不同的厚度或具体的厚度,以使其连同连接器本身与附加到连接器的锚固构件的圆柱形部分的轮廓匹配。此外,考虑了治疗性或诊断性凝胶或其它物质通过移植部署装置或另一种医疗装置(比如导管)的共同输送,以及此外包括相同装置的锚固组件。在一种这样的方法中,部署装置包括保持有凝胶物质的储存器,并且通过该储存器,锚固装置可以被推进以便收集所需的数量的治疗性或诊断性凝胶物质。
应认识到,针和连接器组件的双推进的定时和接下来组件之间的相对运动是协调的。即,针组件首先提供通向介入性部位的通道,并且随后连接器组件通过针和连接器组件的相对运动被延伸到针组件的终端端部以外。
还考虑了在某些实施方式中,锚固输送装置可以包括探测被施加在那里或其它环境条件的力的能力。装置的各个部分可以包括这些装置,并且在一种考虑的方法中,感测器可以被沿着针组件放置。这样,操作者可以探测例如针是否已经破坏位于介入性部位的目标解剖结构以及此种破坏已经发生的程度。也可以采用可以探测具体环境特征的其它感测器,比如血液或其它化学或组分感测器。此外,考虑了一种或多种压力感测器或提供在输送过程中或在移植之后对锚固组件的部署的状态的反馈的感测器。例如,张力或深度反馈可以通过这些感测器被监测。另外,这些感测器可以被并入锚固组件本身、部署装置的其它结构或解剖结构中。
此外,应认识到,前述手术是可逆的。在一种方法中,锚固组件的连接可以被中断,并且近端(或第二)锚固部件可以被从患者的身体移除。例如,医师可以简单地切割连接器,并且同时移除之前移植在例如患者的尿道中的第二锚固件。
本发明的各个实施方式提供的一个方面是输送多种优选地为四种具有定制的长度和远端锚固部件的锚固组件的能力,每个锚固组件被移植在不同的位置而不需要将装置从患者移除。各种实施方式对于输送的多个锚固组件中的每一个提供可变的针深度以及可变的连接器长度。本发明的各个实施方式的其它方面是锚固组件、带有具有集成的连接器(比如缝线)的装置的锚固组件输送装置、切割以及具有设备中的内窥镜的锚固组件输送装置的基于载荷的输送,优选地为1磅。输送装置独特地设置成在间隔开的第一锚固构件之间以及移植的第一锚固件和输送装置之间或第一锚固件和输送装置上面放置这样一种载荷(半磅到五磅)。在此方面,起到穿刺构件作用的针组件可以配合地被连接到在各种锚固构件之间产生所需的张力的机构,同时针组件被收回。而且,此载荷可以在第一和第二移植的锚固构件之间被完成。
应认识到,考虑了用于制造公开的装置的各种材料。而且,一种或多种部件比如本文公开的该一种或多种锚固装置的远端锚固件、近端锚固件、连接器可以被设计成完全地或部分地生物可降解的或生物可分解的。
另外,如陈述的那样,本文公开的装置和方法可以被用于治疗各种管状器官或包括腔或壁的器官中的各种病变。这些器官的例子包括但不限於尿道、肠、胃、食道、气管、支气管、支气管通道、静脉(例如用于治疗曲张的静脉或瓣膜闭锁不全)、动脉、淋巴管、输尿管、膀胱、心脏心房或心室、子宫、输卵管等等。
最后,应知晓,本发明在上文中已经参照本发明的某些例子或实施方式进行了描述,但是可以对那些例子和实施方式做出各种添加、删除、改变和修改,而不背离于本发明预期的精神和范围。例如,一个实施方式或例子的任何元素或属性可以被并入另一个实施方式或例子,或者和另一个实施方式或例子一起使用,除非这样做将致使实施方式或例子不能被授予专利权或不适合于预期的用途。同样,例如在方法的步骤被以具体的顺序描述或列举时,这些步骤的顺序可以被改变,除非这样做将致使实施方式或例子不能被授予专利权或不适合于预期的用途。所有合理的添加、删除、修改和改变应被考虑为描述的例子和实施方式的等价物,并且应被包括在接下来的权利要求的范围内。
因此,从前文应明了,虽然已经说明和描述了本发明的具体形式,但可以做出各种修改而不背离于本发明的精神和范围。
Claims (30)
1.一种用于移植锚固组件的系统,其包括:
至少一个锚固组件,所述锚固组件包括第一锚固构件、第二锚固构件,以及连接器,所述连接器将所述第一锚固构件与所述第二锚固构件连接;以及
锚固输送装置,所述锚固输送装置包括触发器,与所述触发器相互作用的摇臂组件,以及线轴组件,该线轴组件包括使用充足的能量加载的一个或多个弹簧组件,以便推进用于锚固组件的部件;
其中,所述触发器的致动完成了得到通向体内第一部位的通道、所述第一锚固构件独立于所述第二锚固构件的部署、以及所述第二锚固构件的组装。
2.如权利要求1所述的系统,其还包括针组件,其中,所述锚固输送装置包括将所述针组件延伸到不同的深度的结构。
3.如权利要求1所述的系统,其还包括防止所述触发器的不完全致动的机构。
4.如权利要求1所述的系统,其还包括确保输送步骤的恰当次序的多个机构。
5.如权利要求1所述的系统,其还包括针组件,并且其中,触发器的第一拉动导致向远端地推进针组件。
6.如权利要求5所述的系统,其中,触发器的第二拉动导致在介入性部位部署所述第一锚固构件。
7.如权利要求6所述的系统,其中,触发器的第三拉动导致抽出所述针组件。
8.如权利要求7所述的系统,其中,触发器的第一拉动、触发器的第二拉动、触发器的第三拉动或触发器的第四拉动导致在抽出所述针组件之后组装并部署所述第二锚固构件。
9.如权利要求1所述的系统,其中,所述锚固输送装置被设置成用于移植具有可变长度连接器的锚固组件。
10.如权利要求1所述的系统,其中,将所述第二锚固构件附连在所述连接器上所需的位置由所述锚固输送装置来完成。
11.如权利要求1所述的系统,其中,所述锚固输送装置被设置成输送至少两种可变长度的锚固组件。
12.如权利要求1所述的系统,其中,所述锚固输送装置被设置成输送至少四个可变长度的锚固组件。
13.如权利要求1所述的系统,其还包括可收回的针组件,所述可收回的针组件可操作地与所述触发器关联。
14.如权利要求13所述的系统,其中,所述可收回的针组件能够在患者体内被推进到变化的可选择的深度。
15.如权利要求13所述的系统,其还包括设置在所述可收回的针组件内的第一推动器组件,所述第一推动器组件可操作地与所述触发器关联。
16.如权利要求15所述的系统,其中,所述第一锚固构件和连接器被罩在所述可收回的针组件内部,并被放置成与所述第一推动器组件接合。
17.如权利要求15所述的系统,其还包括第二推动器组件,所述第二推动器组件可操作地与所述触发器关联。
18.如权利要求17所述的系统,其中,所述第二锚固构件包括第一部分,所述第一部分被放置成与所述第二推动器组件接合。
19.如权利要求2所述的系统,其还包括用于在部署过程中调节所述针组件的速度的机构。
20.如权利要求13所述的系统,其还包括用于在收回过程中调节所述可收回的针组件的速度的机构。
21.如权利要求20所述的系统,其还包括用于调节所述第一锚固构件的部署速度的机构。
22.如权利要求1所述的系统,其还包括可分离的外部护套。
23.如权利要求22所述的系统,其中,所述可分离的外部护套具有凹陷的锋利边缘,以便在所述锚固输送装置失灵、紧急情况时切割所述连接器。
24.一种用于移植锚固组件的系统,其包括:
至少一个锚固组件,所述锚固组件包括第一锚固构件、第二锚固构件,以及连接器,所述连接器将所述第一锚固构件和所述第二锚固构件连接;以及
锚固输送装置,所述锚固输送装置包括触发器,与所述触发器相互作用的摇臂组件,和张力机构,所述张力机构对所述连接器施加所需的张力;
其中,所述触发器的致动完成了得到通向体内第一部位的通道、所述第一锚固构件独立于所述第二锚固构件的部署、以及所述第二锚固构件的组装。
25.如权利要求24所述的系统,其中,所述张力机构被设置成在所述连接器上提供一磅的力。
26.如权利要求24所述的系统,其中,所述张力机构被设置成在所述连接器上提供半磅到五磅之间的力。
27.如权利要求24所述的系统,其中,所述张力机构被设置成在所述第一锚固构件和所述第二锚固构件之间施加半磅到五磅之间的可选择的张力。
28.如权利要求24所述的系统,其中,所述张力机构被设置成在所述第一锚固构件和所述第二锚固构件之间产生一磅的力。
29.如权利要求24所述的系统,其中,所述张力机构在第二锚固构件的组装之前施加所需的张力。
30.如权利要求24所述的系统,其中,所述张力机构在组装第二锚固构件时施加所需的张力。
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CN104083183A (zh) | 2014-10-08 |
EP2164427B1 (en) | 2017-05-31 |
CN101795641A (zh) | 2010-08-04 |
WO2009009617A1 (en) | 2009-01-15 |
EP2164427A1 (en) | 2010-03-24 |
US8758366B2 (en) | 2014-06-24 |
US20090018553A1 (en) | 2009-01-15 |
EP2164427A4 (en) | 2015-03-18 |
CN104083183B (zh) | 2017-04-12 |
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