CN104105458A - 医疗器械手柄 - Google Patents
医疗器械手柄 Download PDFInfo
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- CN104105458A CN104105458A CN201280068991.6A CN201280068991A CN104105458A CN 104105458 A CN104105458 A CN 104105458A CN 201280068991 A CN201280068991 A CN 201280068991A CN 104105458 A CN104105458 A CN 104105458A
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- sleeve pipe
- door
- handle
- medical instrument
- instrument handle
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2439—Expansion controlled by filaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Abstract
医疗器械手柄可包括细长的手柄外壳(120)，围绕手柄外壳设置的可旋转的套管(156)，围绕套管设置的可旋转的控制旋钮(122)，以及围绕套管设置的可滑动的门(124)。门可旋转地锁定至套管以防止门与套管之间的相对旋转。
Description
背景技术
通常用于心血管系统治疗的医疗器械会涉及复杂且创伤性的疗法，从而使患者具有明显的不适，疼痛，及较长的恢复时间。最近，已经发展出了较小创伤性的经皮治疗。并且一直需要改进的、较小创伤性的心血管治疗。
发明内容
医疗器械手柄可包括细长的手柄外壳，围绕手柄外壳的近端设置的可旋转的套管，围绕套管的近侧部设置的可旋转的控制旋钮，以及围绕套管的远侧部设置的可滑动的门。医疗器械手柄还可包括促动设于手柄远侧的医疗器械的装置，所述装置设置在手柄外壳内。门可旋转地锁定至套管从而防止两者之间的相对运动。
医疗器械手柄可包括手柄外壳，可旋转地围绕手柄外壳的近端设置的管状套管，可旋转地设置在管状套管的近侧部和手柄外壳的近端之上的端部开口的控制旋钮，可滑动地设置在套管远侧部和手柄外壳之上的环状门，其中环状门包括多个向内延伸的突出部，其配置成与套管远侧部中的多个凹口相接合以便门可旋转地锁定至套管。
附图说明
参照附图考虑下面本发明各种实施方式的详细描述可更完整地理解本发明，其中
图1是示例性医疗器械系统的侧视图；
图2是示例性外鞘管的侧剖面图；
图3是沿图2中线3-3的横向剖面图；
图4是示例性内导管的侧视图；
图5是沿图4中线5-5的剖面图；
图6是沿图4中线6-6的剖面图；
图7是与示例性医疗器械系统连接的示例性植入物的一部分的立体图；
图8-11是锁住植入物的示例性机构的立体图；
图12是示例性鞘管辅助件的一部分的侧视图；
图13是示例性鞘管辅助件与示例性植入物相接合的放大平面图；
图14是示例性手柄的侧视图；
图15是示例性手柄一些内部组件的剖开图；
图16-18示出了手柄组件在示例性手柄内协调运动的示例；
图19-20示出了套管在示例性手柄上的旋转；
图21-22示出了套管旋转过程中在示例性手柄内的一些组件；
图23示出了图14的示例性手柄的一些元件；
图24是示例性手柄的门的立体图；
图24A是图24的门的端视图；
图25是示例性手柄的套管的立体图；以及
图25A是图25的套管的端视图。
尽管可对本发明作出各种改型和替换形式，其细节已通过示例的方式在附图中示出，并将详细描述。然而，应当理解，本发明并不限于所描述的特定实施方式。相反，本发明意在覆盖落入到本发明的实质和范围内的所有改型，等同物，及替代物。
具体实施方式
对于下面定义的术语，除非是在权利要求或者是在说明书的其他地方给出了不同的定义，否则应当采用这些定义。
无论是否明确指出，本文假定所有的数值均由术语“大约”修饰。术语“大约”通常是指本领域技术人员会认为是与所述值相当(即，具有相同的功能或结果)的数值范围。在许多情况下，术语“大约”可包括四舍五入为最接近有效数字的数值。
由端点限定的数值范围包括在该范围内的所有数值(例如，1至5包括1、1.5、2、2.75、3、3.80、4和5)。
如在本说明书和所附权利要求中所使用的，单数形式“一”和“该(所述)”包括复数指代，除非文中清楚地表明并非如此。如在本说明书和所附权利要求中所使用的，术语“或者”通常使用其包括“和/或”的含义，除非文中清楚地表明并非如此。
应参考附图阅读下面的详细描述，其中不同附图中相似的附图标记表示相似的元件。附图(其不一定是成比例的)描述了示范性实施方式，而不是旨在限制本发明的范围。
在美国甚至整个世界，影响心血管系统的疾病和/或身体状况是普遍的。通常，通过直接接入系统受影响的部分来进行心血管系统的治疗。例如，通常借助于冠状动脉搭桥手术来治疗一个或多个冠状动脉的阻塞。容易理解地，这种疗法对患者来说具有相当的创伤性，并且需要大量的恢复时间和/或护理。最近，已经发展出较小创伤的疗法，例如，能够通过经皮导管来接入和治疗阻塞的冠状动脉(例如，血管成形术)。这种疗法已经获得了患者和临床医生的广泛认可。
一些相对常见的身体状况可包括心脏内一个或多个瓣膜低效，无效，或完全失效，或者是其结果。例如，主动脉瓣失效对人具有严重的影响，若不治疗会导致严重的健康状况和/或死亡。有缺陷的心脏瓣膜的治疗提出了其它难题，因为该治疗往往要求修复或完全置换有缺陷的瓣膜。这种疗法对患者来说会是极高创伤性的。本文公开了可用于将医疗器械递送至心血管系统的一部分以诊断，治疗，和/或修复该系统的医疗装置。本文公开的医疗器械中至少有一部分可用来递送并植入置换的心脏瓣膜(例如，置换的主动脉瓣)。此外，本文公开的装置可经皮递送置换的心脏瓣膜，由此对患者来说会具有较小的创伤性。本文公开的装置还可提供许多附加的期望特征和益处，如以下详细描述的。
图1是示例性医疗器械系统10的侧视图。应当注意到，为了简明起见，在图1中未示出或示意性示出了系统10的一些特征。在其他附图中更详细的示出了有关系统10的一些组件的额外细节。系统10可用来将多种医疗器械递送和/或安置到身体内的多个位置。在至少一些实施方式中，系统10是能够用于经皮递送置换的心脏瓣膜的置换心脏瓣膜递送系统(例如，置换主动脉瓣递送系统)。然而，这并不是旨在限制系统10，系统10也可用于包括二尖瓣置换，瓣膜修复，瓣膜成形术等的其他介入，或其他类似的介入。
系统10通常可描述为导管系统，其包括外鞘管或导管12以及至少部分地延伸穿过外鞘管12的内导管或管14(在图1中用虚线示出其一部分)。在植入物16的递送过程中，医疗器械植入物16可连接至内导管14，并设置在外鞘管12内。手柄18可设置在外鞘管12和内导管14的近端。通常，手柄18可配置成操控外鞘管12相对于内导管14的位置以及帮助安置植入物16。
在使用中，系统10可经皮前进穿过脉管系统至邻近关注区域的位置。例如，系统10可前进穿过脉管系统至邻近有缺陷的主动脉瓣的位置。在递送过程中，植入物16通常可以以细长且低轮廓的“递送”形态设置在外鞘管12内。一旦定位，外鞘管12可缩回从而露出植入物16。植入物16可被促动以将植入物扩张成适于在体内植入、通常缩短并具有较大剖面的“安置”形态。当把植入物16合适地安置在体内时，系统10能够从脉管中移出，而将植入物16留在适当的位置以起到，例如，适当置换自体主动脉瓣的作用。在至少一些介入中，植入物16可安置在自体瓣膜中(例如，把自体瓣膜留在适当的位置而没有切除)。或者，可移除自体瓣膜，并且可将植入物16安置在自体瓣膜的位置作为置换。
图2-13(及其他附图)示出了系统10的一些组件。例如，图2是外鞘管12的侧剖面图。能够看出，外鞘管12具有近侧部20和远侧部22。远侧部22可具有稍稍增大或外扩的内径，其可提供额外的空间以将植入物16保持在其中。例如，外鞘管12沿近侧部20的内径可在大约0.254到1.27厘米(0.10到0.50英寸)，或大约0.508到1.016厘米(0.20到0.40英寸)，或大约0.508到0.762厘米(0.20到0.30英寸)，或大约0.56388±0.0508厘米(0.222±0.002英寸)的范围内。外鞘管12沿远侧部22的内径可在大约0.254到1.27厘米(0.10到0.50英寸)，或大约0.508到1.016厘米(0.20到0.40英寸)，或大约0.508到0.762厘米(0.20到0.30英寸)，或大约0.579到0.5842厘米(0.228到0.230英寸)的范围内。在远侧部22的远端可为远侧尖端24，其可以外扩或具有像漏斗一样的形状。像漏斗一样的形状增大了外鞘管12在远侧尖端24处的外径(以及内径)，并可有助于将植入物16插入和/或重新插入到外鞘管12中。除了在远侧尖端24之外，外鞘管12可具有大体不变的外径。例如，外鞘管12的外径可在大约0.254到1.27厘米(0.10到0.50英寸)，或大约0.508到1.016厘米(0.20到0.40英寸)，或大约0.508到0.762厘米(0.20到0.30英寸)的范围内，或者大约为0.6858厘米(0.270英寸)。这些仅为示例。可考虑其他实施方式，其具有外鞘管12的外径和/或内径的不同尺寸(包括那些适于包含儿童在内的不同体形患者的尺寸)和/或布局。所考虑的这些实施方式包括具有外扩或可变的外径的外鞘管，具有不变的内径的实施方式，及其组合等。外鞘管12也可具有适于到达体内预期的关注区域的长度。例如，外鞘管12的长度可在大约30到200厘米，或大约60到150厘米，或大约100到120厘米，或大约108±0.20厘米的范围内。外鞘管12也可弯曲。例如，外鞘管12的远侧段可弯曲。在一个示例中，(从外鞘管12的中心开始测量的)曲线半径可在大约2到6厘米(20到60毫米)，或大约3到4厘米(30到40毫米)的范围内，或者大约为3.675厘米(36.75毫米)。再次，这些尺寸仅为示例，并不是旨在限制本发明。
外鞘管12可由单个的整体式管或单元部件构成。或者，外鞘管12可包括多个层或部分。这些层中的一个或多个可包括诸如编织物、线圈、网孔，及其组合等的加强结构。图3示出了外鞘管12的多层结构的一个示例。例如，外鞘管12可包括内衬或层26。中间或叠层28可设在内衬26上。加强件30可设在中间层28上。表面层或外层32可设在加强件30上。最后，可沿表面层32的部分或者全部设置外涂层34(例如润滑涂层，亲水涂层，疏水涂层等)。这些仅为示例。可考虑外鞘管12若干替代的结构性配置，包括具有两层或更多层(其可不同于图3中示出的那些层)的实施方式，不具有加强件的实施方式等，或其他合适的配置。
用于外鞘管12的各层的尺寸和材料也可不同。例如，内衬26可包含诸如氟化乙烯丙烯(Fluorinated Ethylene Propylene，FEP)的聚合物材料，并且厚度可在大约0.00254到0.0127厘米(0.001到0.005英寸)或大约0.00762±0.00254(0.003±0.001英寸)的范围内，中间层28可包含诸如聚醚嵌段酰胺(例如，PEBAX 6333)的聚合物材料，并且厚度可在大约0.00254到0.0127厘米(0.001到0.005英寸)或大约0.00508±0.00254(0.002±0.001英寸)的范围内，外涂层34可包含诸如聚醚嵌段酰胺(例如，PEBAX 7233)的聚合物材料，并且厚度可在大约0.00254到0.0254厘米(0.001到0.01英寸)的范围内。在一些实施方式中，外涂层34的厚度可以变化。例如，外涂层34沿近侧部20的厚度(诸如大约0.0127到大约0.0508厘米或大约0.02159厘米(0.005到0.02英寸或大约0.0085英寸))可大于外涂层34沿远侧部22和/或远侧尖端24的厚度(其可为大约0.0127到大约0.0508厘米或大约0.01651厘米(大约0.005到0.02英寸或大约0.0065英寸))。由于可使用其他合适的材料，这些仅为示例。
远侧尖端24的形式也可变化。例如，在至少一些实施方式中，内衬26(即，其2.5毫米部分)可向上并且绕着外鞘管12的远端(例如，绕着加强件30和表面层32)延伸。由诸如55D聚醚嵌段酰胺(例如，55D PEBAX)的合适材料制成的环状部件(未示出)可设在内衬26的上方并且是热粘合的以形成远侧尖端24。这可使远侧尖端24形成像漏斗的形状。
加强件30的形式也可变化。在至少一些实施方式中，加强件30可表现为编织物、线圈、网孔等形式。例如，在一些实施方式中，加强件30可包含金属编织物(例如，不锈钢)。在这些实施方式中的一些中，加强件30也可包括诸如一个或多个纵向延伸线的附加结构。例如，加强件30可包括一对设于编织物两侧上纵向延伸的芳族聚酰胺和/或对位芳族聚酰胺线(例如，)。可将或者不将这些线编织到编织物的部分或全部中。
图4是内导管14的侧视图。内导管14的远端区域可包括外径台阶部40，其界定出减小的外径段42。例如，与内导管14的其余部分相反(这里外径可在大约0.127到0.762厘米(0.05到0.30英寸)，或大约0.254到0.635厘米(0.10到0.25英寸)，或大约0.508±0.0254厘米(0.20±0.01英寸)的范围内)，减小的外径段42的外径可在大约0.127到0.635厘米(0.05到0.25英寸)，或大约0.254到0.508厘米(0.10到0.20英寸)，或大约0.38608±0.00762厘米(0.152±0.003英寸)的范围内。减小的外径段42可界定出可附装系统10的其他组件的区域。有关这些组件的一些额外细节能从下文中看出。
通常，内导管14可表现为挤压聚合物管的形式。也可考虑其他形式，包括其他聚合物管，金属管，加强管，或包含诸如本文公开的其他合适材料的类似物。在一些实施方式中，内导管14是单个的整体式或单元部件。在其他实施方式中，内导管14可包括多个连接在一起的部分或段。内导管的总长度可在大约60到150厘米，或大约80到120厘米，或大约100到115cm，或大约112±0.02厘米的范围内。就像外鞘管12一样，内导管14也可弯曲，例如在邻近其远端处。在一些实施方式中，内导管14可具有一个或多个具有不同硬度/刚度(例如，不同的邵氏硬度)的段。例如，内导管可具有近侧区域44a和中间区域44b。近侧区域44a可包含诸如72D聚醚嵌段酰胺(例如，72D PEBAX)的一般刚性聚合物材料，并且长度可在大约60到150厘米，或大约80到120厘米，或大约100到115厘米，或大约109.5±0.02厘米的范围内。中间区域44b可包含40D聚醚嵌段酰胺(例如，40D PEBAX)，并且长度可在大约5到25毫米，或大约10到20毫米，或大约15±0.01毫米的范围内。在一些实施方式中，减小的外径段42也可不同于区域44a/44b，可包含72D聚醚嵌段酰胺(例如，72D PEBAX)，并且长度可在大约0.5到2厘米(5到20毫米)，或大约0.8到1.5厘米(8到15毫米)，或大约1±0.001厘米(10±0.01毫米)的范围内。这些仅为示例。
内导管14可包括一个或多个腔。例如，图5(其是内导管14在邻近近侧端部36处的剖面图)示出内导管14可包括第一腔46，第二腔48，第三腔50，及第四腔52。通常，腔46/48/50/52沿内导管14的整个长度延伸。然而，可考虑其他的实施方式，其中腔46/48/50/52中的一个或多个仅沿内导管14长度的一部分延伸。例如，第四腔52可在差不多就要到内导管14的远端处停止和/或第四腔52可在它的远端处被填满从而在接近内导管14的远端处有效地终止第四腔52，如图6所示，在邻近内导管14的远端处不存在第四腔52。
推拉杆84(未在图5中示出，从包括图7在内的其他附图中看出)可设在第一腔46中，其用来扩张和/或拉伸植入物16，如下文详细描述的。在至少一些实施方式中，第一腔46可衬有低摩擦衬里54(例如，FEP衬里)。销释放心轴92(未在图5中示出，从包括图7在内的其他附图中看出)可设在第二腔48中，其也将在下文详细描述。在至少一些实施方式中，第二腔48可衬有海波管(hypotube)衬里56。第三腔50可以是导丝腔，该腔也可衬有海波管衬里58。
第四腔52可用来容纳非拉伸线60。非拉伸线60的形式可以变化。在一些实施方式中，非拉伸线60可表现为不锈钢编织物的形式。非拉伸线60可选择地包括一对设置在编织物两侧上纵向延伸的芳族聚酰胺及/或对位芳族聚酰胺线(例如，)。通常，非拉伸线60可嵌入在第四腔52中，而不是“内设于”第四腔52中。此外，非拉伸线60可延伸至邻近远侧端部38但没有完全碰到内导管14远端的位置处，如图6所示，在邻近内导管14的远端处不存在第四腔52。例如，在邻近内导管14的远端处，第四腔52短的远侧段可用聚合物材料填充。
内导管14也可包括导丝延伸管62，其从远侧端部38向远侧延伸。鼻锥(nosecone)64附装至导丝延伸管62。鼻锥64通常设计成具有防止损伤的形状。鼻锥64还可包括脊或檐66，其配置成在植入物16递送的过程中紧靠外鞘管12的远侧尖端24。
图7示出了系统10的一些附加组件和植入物16。例如，能够看出植入物16包括多个瓣叶68(例如，牛心包)，其在杆或接合杆72处，例如在小叶68的接合部，固定至圆筒状编织物70。在这个示例中，植入物16包括三个通过三个杆72固定至编织物70的小叶68。小叶68也可固定至编织物70的基部或“远端”。转而，杆72可通过缝线或其他合适的机构固定至编织物70(例如，沿编织物70的内部)。多个搭扣76邻近(例如，纵向隔开并对齐)杆72放置，搭扣76也可缝合在编织物70上(例如，沿编织物70的内部)。在这个示例中，一个搭扣76在邻近三个杆72中每个杆的位置处附装至编织物70。于是，编织物70总共有三个附装其上的搭扣76以及三个附装其上的杆72。也可考虑其他的实施方式，其中可使用更少或更多的搭扣76及杆72。密封件74(以剖面示出)可围绕编织物70设置，顾名思义，密封件74可有助于将植入物16密封在目标植入部位或关注区域中。
可通过使用三棘爪连接件78来实现植入物16与内导管14(和/或外鞘管12)之间的附装。连接件78通常可包括附装至内导管14(例如，围绕减小的外径段42设置并附装其上)的圆柱形基部(未示出)。三个棘爪从基部向远侧突出，各棘爪配置成在杆72和搭扣76处与植入物16接合。套管80可进一步帮助将这些结构保持在一起。引导件82可设置在每个棘爪的上方并可用来保持连接件78的棘爪与邻近连接件78延伸的推拉杆84相连接。最终，销释放配件86可以是保持杆72、搭扣76、和推拉杆84相互连接的连接结构。销释放配件86包括多个单独的销88，其可通过螺旋连接件90连接在一起，并通过金属箍94固定至销释放心轴92。
在递送过程中，凭借与搭扣76突出的近端相连接(并且通过设置在连接上方的套管80保持在合适的地方)的连接件78的棘爪的连接，并凭借将推拉杆84和杆72固定在一起的销88，植入物16被固定在内导管14的远端。当植入物16在人体内前进至期望的位置时，外鞘管12可缩回(例如，相对于内导管14向近侧移动)从而露出植入物16。然后，通过向近侧缩回推拉杆84以拉动杆72使其与搭扣76接合，推拉杆84能够用来扩张植入物16并将植入物16“锁定”在扩张或安置形态。最后，移出销88，藉此使得推拉杆84与杆72松开，这使得植入物16从系统10释放出来并安置在人体内。
图8-11示出了系统10使用的锁定系统。简明起见，仅示出示例性系统10的连接件78三个棘爪中的一个，三个推拉杆84中的一个，以及多个杆72中的一个(未示出植入物16)。如图8所示，推拉杆84在邻近连接件78的棘爪处延伸穿过引导件82，穿过套管80，穿过搭扣76，然后进入杆72的中空t形条状部96中。推拉杆84的远端可包括能够与t形条状部96的开口98对齐的开口或孔(未示出)。当这样对齐时，销88能够依次穿过开口98和推拉杆84的开口。这将推拉杆84固定至杆72上并形成这些结构能够在递送植入物16的过程中使用的配置。能够理解，杆72的近端和搭扣76的远端纵向隔开，于是植入物16处于适于递送的细长且通常低轮廓的形态。
当植入物16在体内到达预期的目标部位时，临床医生能够使推拉杆84向近侧缩回，藉此使杆72的近端朝向搭扣76的远端移动以便使植入物16扩张。最终，推拉杆84能够缩回足够远使得杆72与搭扣76锁住以便将植入物锁定在适于植入人体的扩张形态。图9示出了向近侧缩回的推拉杆84。这样做时，杆72与搭扣76形成接触。更具体地，可向近侧拉t形条状部96上抬高并且通常横向取向的脊100越过搭扣76以便通过搭扣76固定住杆72并将杆72保持在适当的位置。这时，能够向远侧推动推拉杆84以“解锁”植入物16，藉此允许进行再定位和/或缩回。或者，若临床医生对植入物16的定位和/或锁定满意(例如，在通过合适的成像技术观察到植入物16之后)，可拉销88(例如，从开口98以及推拉杆84中的开口中移出销88)以使得推拉杆84与杆72松开，如图10所示。推拉杆84的进一步缩回导致推拉杆84上的纵向取向脊102与套管80接合，并导致套管80沿连接件78的棘爪向近侧滑动。这样做时，棘爪的分叉端104(其具有在其中形成的凹槽106)露出来，并且能够与轨道108分离，轨道108具有在其上形成的凸部110，凸部110配置成与凹槽106相匹配，如图11所示。此后，能够从体内移出系统10，而将扩张且安置的植入物16留下。
图12-13示出了系统10可包括的另一组件。例如，图12是鞘管辅助件112的一部分的侧视图。能够看出，鞘管辅助件112包括基部114和一组包括三个较长瓣状部116和一对较短瓣状部118的瓣状部。在使用中，一组瓣状部116/118可设置在连接件78的每个棘爪之间。由于连接件78总共具有三个棘爪，鞘管辅助件112可具有总共十五个瓣状部(例如，三组，每组包括三个“长”瓣状部116和两个“短”瓣状部118，各组设置在连接件78相邻的一对棘爪之间)。基部114可在邻近连接件78处固定至内导管14(例如，在连接件78的下方并且在连接件78与内导管14之间)。
顾名思义，鞘管辅助件112可用来帮助将植入物16插入到外鞘管12中。此外，鞘管辅助件112可帮助植入物16的初次插入(例如，将植入物16从诸如瓶子的包装容器中取出并把植入物16拉到外鞘管12中)以及植入物16在关注区域内再定位和/或缩回的过程中再次插入植入物16。插入可通过各种瓣状部116/118的布局和定位来完成。例如，图13示出了穿插在编织物70中的较长瓣状部116，以及沿编织物70的外部设置作为插入漏斗的较短瓣状部118。
图14是手柄18的侧视图。能够看出，手柄18包括手柄外壳120。可旋转的控制旋钮122可围绕手柄外壳120(例如，在手柄外壳120的近端)设置，并可用来移动系统10的一个或多个组件(例如，外鞘管12，推拉杆84等)。可旋转的套管156可围绕手柄外壳120设置。在一些实施方式中，控制旋钮122可围着套管156的近侧部设置。可滑动的门124也可围绕手柄外壳120设置。门124可向远侧平移以露出大致位于门124下方的可旋转套管156的远侧部(未在图14中示出，能从包括图19-20在内的其他图看出)。可旋转套管156来移动系统10的一个或多个组件(例如，推拉杆84，销释放心轴92等)。与手柄18的外部元件(例如，门124，套管156等)有关的一些额外细节可从图23-25A中看出，并在下文进一步讨论。
手柄18也可包括一个或多个孔129a/129b和/或冲洗接口126/128，其能够用来冲洗系统10。在一些实施方式中，远侧冲洗接口126和近侧冲洗接口128可分别从手柄外壳120的外部通过远侧孔129a和近侧孔129b接入。
图15是手柄18的侧视图，其中移除了手柄外壳120的一部分，从而露出至少一些内部组件。能够看出，外鞘管12可附装至鞘管接头130。鞘管接头130附装至鞘管滑动架132，其可拧在丝杆134上。远侧冲洗接口126可设置在鞘管接头130上。通常，远侧冲洗接口126提供了通向外鞘管12的内部或管腔的通路(例如，通向内导管14和外鞘管12之间的空间的通路)，以便临床医生能够在使用系统10之前通过外鞘管12的管腔冲刷流体以去除其中任何不想要的物质(例如，空气、液体、污染物等)。在至少一些实施方式中，远侧冲洗接口126具有鲁尔(luer)式接头(例如，单路鲁尔接头)，其使得带有相应接头的器械诸如注射器能够附装在其上以进行冲洗。
内导管14延伸穿过鞘管接头130并从鞘管接头130向近侧延伸。内导管14的近端附装(例如，固定地附装)至内部体或分流器136。分流器136附装至支撑体140。通常，分流器136和/或支撑体140可具有一个或多个在其内形成的通路或管腔。在一些实施方式中，推拉杆84和/或销释放心轴92可延伸穿过各自的通路。或者，推拉杆84和/或销释放心轴92的近端可各自附装至轴或海波管(例如，实心截面，管状等)，并且每个轴可延伸穿过一个或多个通路。例如，第一轴或海波管142和第二轴或海波管144可延伸穿过分流器136中的通路，在一些实施方式中，第一轴或海波管142延伸穿过第一通路，而第二轴或海波管144延伸穿过第二通路，第二通路与第一通路分开或与第一通路不同。在至少一些实施方式中，第一轴142附接至销释放心轴92。在至少一些实施方式中，第二轴144附接至推拉杆84。应当注意到，在系统10的至少一些实施方式中，使用了三个推拉杆84。在这些实施方式中，三个推拉杆84在邻近内导管14的远端处集合(例如，相互之间形成接触或相互之间形成相对靠近的)并进入第一腔46。在沿其长度方向的一个或多个位置处，推拉杆84可相互附装。例如，在一些实施方式中，推拉杆84可在距其远端大约10.16厘米(大约4.00英寸)处焊接在一起。在一些实施方式中，除了远侧焊接之外或者作为远侧焊接的替代，推拉杆84可在靠近其近端处焊接在一起。其后，推拉杆84可向近侧延伸至第二轴144。
海波管(例如，沿导丝腔52设置的海波管衬里58)可在其通路内延伸穿过分流器136，然后绕分流器136和支撑体140的一部分“被分流”，并最终延伸至在手柄18近端所处的位置，从而提供了通向导丝腔52的用户接入。近侧冲洗接口128可设置在支撑体140上，近侧冲洗接口128能够用来冲洗内导管14的管腔，例如，可起到与远侧冲洗接口126类似的作用。
在它们各自的近端，第一轴142可固定至滑动件146，而第二轴144可固定至力限制器体150。各种组件之间的连接可包括许多不同类型的连接，包括机械结合(例如，钉住，螺纹连接，过盈配合等)，粘结，热结合等。滑动件146可相对于力限制器体150滑动。在一些实施方式中，滑动件146可有选择地锁定至力限制器体150，藉此防止滑动件146与力限制器体150之间的相对运动。力限制器体150可固定至推拉杆滑动架152，其可拧到丝杆134上。这样，丝杆134的移动能够导致推拉杆滑动架152和力限制器体150的移动，并由此导致推拉杆84(通过第二轴144)移动。下文记载了有关这一运动的一些附加细节。
通常，力限制器体150形成或界定了止动点，其向使用者提供触觉反馈(例如，进一步旋转控制旋钮122的阻力)以表明推拉杆84已向近侧缩回足够的距离使得用搭扣76锁住杆72。为了验证是否正确锁住，临床医生可使用适当的可视技术来可视化正确的锁定(例如，杆72和搭扣76的相对定位)。楔块148可邻近滑动件146放置以有选择地将滑动件146锁定至力限制器体150。为了使销释放心轴92向近侧缩回以拉动销88，楔块148能够旋转或移动至二级位置或状态。当处于这一状态时，例如，楔块148不再成为滑动件146和销释放心轴92进一步移动的障碍物。于是，由于楔块148不再起到阻挡的作用，滑动件146和销释放心轴92能够向近侧缩回，从而通过拉动销88而有助于植入物16的安置。
手柄18还包括可旋转的环155，其具有配置成与连接至丝杆134的齿轮157上的齿相啮合的内齿。环155连接至控制旋钮122，使得控制旋钮122的旋转导致环155进行类似的运动，从而导致丝杆134进行类似的运动。
通常配置手柄18来协调系统10多个结构的运动。例如，手柄18配置成允许使用者移动外鞘管12(例如，相对于内导管14)、移动推拉杆84，以及移动销释放心轴92。此外，手柄18配置成在介入过程中能够在适当的时机移动适当的结构，从而能够有效地递送植入物16。如何在手柄18内产生系统10的协调运动的一些示例类似于在美国专利申请公告第US 2010/0280495号中公开的那些内容，通过引用的方式将其全部内容合并在此。
为了帮助促进协调运动，手柄18可包括空转筒158。空转筒158配置成在介入过程中的不同时刻接合滑动架132/152和/或与滑动架132/152相连接的螺钉从而使运动停止(例如，产生适当滑动架的“无效运动”)。图16-19示出了通过手柄18实现的一些协调运动。应当注意到，为清楚起见，图16-20未示出系统10的一些元件。例如，图16示出了手柄18的第一位置或状态，这里外鞘管12相对于内导管14(以及手柄18)向远侧延伸以便将植入物16完全套住(例如，完全容纳植入物16)。当处于这一位置时，鞘管滑动架132邻近手柄18的远端。此外，与推拉杆滑动架152连接的螺杆(rod screw)152a从推拉杆滑动架152向远侧延伸并位于空转筒158内。一旦控制旋钮122旋转(例如，沿顺时针方向)，丝杠134就开始旋转。丝杠134的旋转导致鞘管滑动架132沿丝杠134向近侧方向移动，从而导致外鞘管12向近侧移动(例如，植入物16“出鞘”)。丝杠134的这一初始旋转也导致螺杆152a旋转。这可能是由于，例如，螺杆152a上的旋钮或凸部(未示出)与沿空转筒158内部设置的螺旋螺纹相啮合。然而，由于螺杆152a与推拉杆滑动架152相隔开，这不会在推拉杆滑动架152上施加力。由此，控制旋钮122的初始运动不会造成推拉杆滑动架152的移动，相反的，仅造成鞘管滑动架132的平移以及螺杆152a的旋转(及平移)。
最终，螺杆152a(例如，在其中形成的旋钮)到达在空转筒158端部形成的基本直线形的螺纹或路径。直线形的螺纹允许螺杆152a沿丝杠134平移至螺杆152a接触(例如，拧入其中并紧靠)推拉杆滑动架152的位置。这样做时，螺杆152a能够接触推拉杆滑动架152并使推拉杆滑动架152向近侧移动。于是，丝杠134的进一步旋转不仅导致鞘管滑动架132向近侧移动，而且导致推拉杆滑动架152向近侧移动，如图17所示。
当鞘管滑动架132到达空转筒158时，鞘管滑动架132的鞘管滑动架螺钉132a进入空转筒158，如图18所示。这一运动方式可与螺杆152a拧入和拧出沿空转筒158形成的螺旋螺纹的方式相类似。例如，当鞘管滑动架132平移时，鞘管滑动架螺钉132a可跟着沿或邻近空转筒158形成的基本直线形的螺纹或路径。一旦到达空转筒158，鞘管滑动架螺钉132a(例如，在其上形成的旋钮或凸部)就可切换为与空转筒158内的螺旋螺纹相啮合并旋转。这一旋转使得鞘管滑动架螺钉132a从鞘管滑动架132中“拧出”。于是，丝杠134的进一步旋转导致推拉杆滑动架152向近侧持续移动，而鞘管滑动架132的运动停止。
在至少一些实施方式中，丝杠134具有多个螺纹节距不同的部分，例如，第一部分134a和第二部分134b。这可允许滑动架132/152沿丝杠134以不同速率行进。例如，丝杆134的在鞘管滑动架132沿其平移处的节距通常可比邻近推拉杆滑动架152位置处的间距更大或更倾斜。于是，滑动架132/152的协调运动也可配置成使得鞘管滑动架132沿丝杆134以比推拉杆滑动架152更快的速率平移。也可考虑与上述结构相反的配置，以及丝杠134的节距基本不变或包括许多不同节距区域的其他配置。
推拉杆滑动架152向近侧充分缩回，例如如图18所示，可导致推拉杆84充分缩回以致杆72能够与搭扣76接合并锁定。当临床医生对锁定完成满意时(例如，在通过适当的可视化技术检查之后)，临床医生可向近侧缩回销释放心轴92以从开口98和推拉杆84中的开口拉出销88从而释放植入物16。
为了开始释放销88，门124可沿套管156(其位于手柄18上)向远侧滑动，如图19所示。当门124充分前进时，门124和套管156能够一起旋转，如图20所示。推拉杆滑动架152还可包括径向延伸的近侧旗状部件164。通常，旗状部件164可设计为能够防止套管156过早旋转(并由此防止过早拉出销88)的突出结构。例如，旗状部件164可位于沿套管156内部的凹槽(未示出)内并跟随所述凹槽。当位于凹槽内时，旗状部件164基本形成防止套管156相对于手柄外壳120旋转的物理障碍物。当推拉杆滑动架152向近侧平移至手柄外壳120的后部时(例如，当推拉杆84向近侧缩回以致锁定杆72与搭扣76时)，旗状部件164离开套管156中的凹槽。于是，旗状部件164不再阻碍套管156的旋转，正因为如此，套管156此时能够旋转以拉出销88。
套管156通过环154与齿轮160连接，齿轮160与第二螺杆162啮合。在套管156近端的槽口与环154上的凸部啮合使得套管156的旋转导致环154相应的旋转，从而使得第二螺杆162相应的旋转。套管156的初始旋转足以使楔块148从第一状态旋转至第二状态(例如，通过套管156与楔块148之间导致楔块148移动的机械相互作用)，从而使销88向近侧缩回并拉动销88(例如，通过第一轴142和销释放心轴92，销释放芯轴92连在销88上)，在所述第一状态，滑动件146可选择地锁定至力限制器体150(由此也使得销释放心轴92可选择地锁定至力限制器体150)，在所述第二状态，允许滑动件146随第二螺杆162旋转而沿第二螺杆162平移。如图21中看出的，处于第一状态的楔块148与沿力限制器体150顶部的脊168卡合，这形成了防止滑动件146相对于力限制器体150向近侧平移的物理障碍物。当旋转套管156而将楔块148切换至第二状态时，随着套管156绕手柄外壳120旋转，滑动件146能够在设于力限制器体150顶部的凹槽166内向近侧平移(例如，如图22所示)从而把销88从开口98和推拉杆84远端的开口中拉出。一旦移出销88，推拉杆84就可从植入物16中退回，藉此将植入物安置在目标部位(关注区域)。
安置植入物16之后，可旋转控制旋钮122以使得鞘管滑动架132在手柄外壳120内向远侧移动，藉此使外鞘管12相对于内导管14和三棘爪连接件78向远侧移动以便覆盖或再次套住系统10设于远端的元件。然后，可从患者体内取出系统10。
图23是图14的手柄18近端的侧视图，其中移去了门124。如上面讨论的，手柄18可包括手柄外壳120。套管156可围绕手柄外壳120的近端设置。控制旋钮122可围绕套管156的近侧部500设置。控制旋钮122可选择地绕手柄外壳120的近端和套管156的近侧部500旋转，并可起到如上所述的作用。
套管156可选择地绕手柄外壳120旋转，如上所述。套管156可包括近侧部500、中心部502、和远侧部504，如图25所示。近侧部500可包括多个配置成与环154上的多个突出部接合的槽口，如上所述。中心部502可包括围绕中心部502设置的径向延伸法兰部530。如从图14中看出的，法兰部530可把控制旋钮122与门124纵向隔开。套管156还可包括在套管156内部上的凹槽520，如图25和25A中看出的。推拉杆滑动架152的径向延伸旗状部件164可处在凹槽520内从而起到接合状态下连锁元件的作用。在接合状态下，其中标记元件164位于凹槽520内，标记元件物理地防止套管156相对于手柄外壳120旋转。随着推拉杆滑动架152在手柄外壳120内向近侧平移，旗状部件164在凹槽520内向近侧类似地平移。当推拉杆滑动架152向近侧平移充足的距离时，旗状部件164离开凹槽520从而实现脱啮状态。在脱啮状态下，允许套管156相对于手柄外壳120旋转。远侧部504可包括多个在其外表面中纵向取向的凹槽510。
门124可围绕套管156的远侧部504设置。门124可沿手柄外壳120的纵向轴线在闭合位置(例如，如图14所示)和打开位置(例如，如图19所示)之间轴向地滑动，在闭合位置处，门124覆盖套管156的远侧部504，在打开位置处，门124不覆盖套管156的远侧部504的全部或部分。在一些实施方式中，套管156，控制旋钮122，和门124可围绕手柄外壳120的纵向轴线同心地设置。
如图23所示，手柄外壳120可包括至少一个从手柄外壳120外表面径向向外延伸的挡块400。门124可包括至少一个在其内表面中的凹槽302(例如，如图24和24A所示)，其中所述至少一个凹槽302配置成在闭合位置容纳所述至少一个挡块400并与其协作以防止门124相对于手柄外壳120旋转。在一些实施方式中，所述至少一个凹槽302没有延伸门124的整个长度。于是，当门124向远侧平移充分的距离时，挡块400会离开凹槽302，因此允许门124相对于手柄外壳120旋转。
手柄外壳120也可包括围绕手柄外壳120设置的径向延伸的脊402。套管156的远端可紧靠脊402的近侧面，如图23所示。门还可包括多个从门124的内表面径向向内延伸的突出部300。在一些实施方式中，突出300通常可以是纵向细长并具有与槽510相似的尺寸和/或形状。突出部300可接合多个在套管156外表面中的凹槽510以防止门124和套管156之间的相对旋转。也就是说，突出部300以将门124可旋转地锁定至套管156的方式与槽510接合以致门124和套管156必须一起或协力地旋转。
于是，当门124处于闭合位置和/或当旗状部件164处于接合状态时，门124和/或旗状部件164可防止套管156相对于手柄外壳120旋转。在旗状部件164向近侧移动至脱啮状态后，门124可向远侧滑动到打开位置。当门124处于打开位置时，多个突出300的远端可紧靠脊402的近侧面。在这种条件下，套管156自由地绕手柄外壳120旋转。门124和套管156协作以形成把手，其可被旋转以移动楔块148并拉动销88从而将推拉杆84从杆72中释放出来，如上所述。由门124和套管156协作形成的把手为使用者/从业者握住并旋转提供了比单独的套管156更宽、更大直径的表面。
能够用于系统10(和/或本文公开的其他系统)的各种组件和本文公开的各种管状部件的材料可包括那些通常与医疗设备有关的材料。简明起见，下面的讨论涉及外鞘管12和/或内导管14。然而，这并不是旨在限制本文公开的装置和方法，讨论可适用于本文公开的其他类似管状部件和/或管状部件或装置的组件。
外鞘管12和/或内导管14可由金属，金属合金，聚合物(下文公开了其一些示例)，金属-聚合物复合物，陶瓷，及其组合等，或者其他合适的材料。合适的金属和金属合金的一些示例包括诸如304V，304L，和316LV不锈钢的不锈钢；软钢；诸如线弹性和/或超弹性镍诺钛的镍-钛合金；诸如镍-铬-钼合金(例如，诸如625的UNS:N06625，诸如的UNS:N06022，诸如的UNS:N10276，其他合金等)的其他镍合金，镍-铜合金(例如，诸如400，400，400等的UNS:N04400)，镍-钴-铬-钼合金(例如，诸如等的UNS:R30035)，镍-钼合金(例如，诸如 的UNS:N10665)，其他镍-铬合金，其他镍-钼合金，其他镍-钴合金，其他镍-铁合金，其他镍-铜合金，其他镍-钨合金或钨合金等；钴-铬合金；钴-铬-钼合金(例如，诸如等的UNS:R30003)；铂富集不锈钢；钛；及其组合等；或者任何其他合适的材料。
如本文提到的，在市售镍-钛或镍诺钛合金的家族里，有称作“线弹性”或“非超弹性”的种类，尽管其在化学性质方面类似于常见的形状记忆和超弹性种类，但其可呈现出独特且有益的机械性能。线弹性和/或非超弹性镍诺钛与超弹性镍诺钛的区别可在于，线弹性和/或非超弹性镍诺钛在应力/应变曲线中不具有实质的“超弹性坪”(“superelastic plateau”)或“标记区域”(“flag region”)，而超弹性镍诺钛则具有。相反，在线弹性和/或非超弹性镍诺钛中，随着可恢复应变增大，应力以大致线性，或稍微线性，但不必完全线性的关系持续增大直至塑性变形开始或者至少以比超弹性镍诺钛所示的超弹性坪和/或标记区域更为线性的关系。这样，为了本公开的目的，线弹性和/或非超弹性镍诺钛也可称为“大致”线弹性和/或非超弹性镍诺钛。
在一些情况下，线弹性和/或非超弹性镍诺钛与超弹性镍诺钛的区别也可在于，线弹性和/或非超弹性镍诺钛可在保持大致弹性的同时承受多达大约2-5％的应变(例如，在塑性变形之前)，而超弹性镍诺钛在塑性变形之前可承受多达大约8％的应变。这两种材料都能够与诸如不锈钢的其他线弹性材料(其也能够根据组分而区别开)区别开，其他线弹性材料在塑性变形之前仅可承受大约0.2到0.44％的应变。
在一些实施方式中，线弹性和/或非超弹性镍-钛合金是不具有任何马氏体相变/奥氏体相变的合金，相变可通过差示扫描量热仪(DSC)和动态金属热分析(DMTA)在很大的温度范围内进行分析而检测得到。例如，在一些实施方式中，在大约-60摄氏度(℃)到大约120℃的范围内通过差示扫描量热仪(DSC)和动态金属热分析(DMTA)未测得线弹性和/或非超弹性镍-钛合金的马氏体相变/奥氏体相变。因此，在这个非常宽广的温度范围内，这种材料的机械弯曲性能通常不会受到温度的影响。在一些实施方式中，线弹性和/或非超弹性镍-钛合金在环境温度或室温下的机械弯曲性能与在体温下的机械性能基本相同，例如，都不显示超弹性坪和/或标记区域。换句话说，在宽广的温度范围内，线弹性和/或非超弹性镍-钛合金保持其线弹性和/或非超弹性特性和/或性能。
在一些实施方式中，线弹性和/或非超弹性镍-钛合金中镍的重量百分比可在大约50到大约60的范围内，其余部分基本为钛。在一些实施方式中，镍的重量百分比在大约54到大约57的范围内。合适的镍-钛合金的一个示例是日本神奈川县的Furukawa Techno Material Co.销售的FHP-NT合金。在美国专利第5,238,004号和6,508,803号中公开了镍钛合金的一些示例，通过引用将其合并在此。其他合适的材料可包括ULTANIUMTM(可从Neo-Metrics公司购买)和GUM METALTM(可从丰田公司购买)。在一些其他的实施方式中，超弹性合金(例如超弹性镍诺钛)能够用来实现期望的性能。
在至少一些实施方式中，外鞘管12和内导管14的部分或全部也可掺杂有，材料为，或包括不透射线的材料。不透射线的材料理解为能够在医疗过程中在荧光透视屏或其他成像技术上生成相对较亮图像的材料。这个相对较亮的图像可帮助系统10的使用者判定其位置。不透射线的材料的一些示例能够包括但不限于，金，铂，钯，钽，钨合金，装有不透射线的填料的聚合物材料等。此外，其他不透射线的标记带和/或线圈也可包括在系统10的设计中以实现相同的结果。
在一些实施方式中，给予系统10一定程度的磁共振成像(MRI)兼容性。例如，外鞘管12和内导管14，或其部分，可由基本不使图像失真及生成实质伪影(即，图像中的间隙)的材料制成。例如，某些铁磁材料可能不适合，因为它们会在MRI图像中生成伪影。外鞘管12和内导管14，或其部分，也可由MRI机器能够成像的材料制成。显示出这些特性的一些材料包括，例如钨，钴-铬-钼合金(例如，诸如等的UNS:R30003)，镍-钴-铬-钼合金(例如，诸如等的UNS:R30035)，镍诺钛等，以及其他材料。
鞘管或罩子(未示出)可设在外鞘管12和内导管14的部分或全部上，其可界定出系统10通常光滑的外表面。然而，在其他实施方式中，系统10的部分或全部可不具有此类鞘管或罩子，以致外鞘管12和内导管14可形成外表面。鞘管可由聚合物或其他合适的材料制成。合适的聚合物的一些示例可包括聚四氟乙烯(PTFE)，四氟乙烯(ETFE)，氟化乙烯丙烯(FEP)，聚甲烯(POM，例如，杜邦公司出售的)，聚醚嵌段酯，聚氨酯(例如，聚氨酯85A)，聚丙烯(PP)，聚氯乙烯(PVC)，聚醚酯(例如，DSM工程塑料公司出售的)，醚基或酯基共聚物(例如，丁基/聚(亚烃基醚)邻苯二甲酸酯和/或诸如杜邦公司出售的的聚酯弹性体)，聚酰胺(例如，拜尔公司出售的或埃尔夫阿托公司出售的)，弹性体聚酰胺，嵌段聚酰胺/醚，聚醚嵌段酰胺(PEBA，例如以为商标名出售的产品)，乙烯-乙酸乙烯酯共聚物(EVA)，硅树脂，聚乙烯(PE)，高马勒克斯高密度聚乙烯，高马勒克斯低密度聚乙烯，线性低密度聚乙烯(例如，)，聚酯，聚对苯二酸丁烯酯(PBT)，聚对苯二酸乙烯酯(PET)，聚对苯二酸三甲烯酯，聚萘二甲酸乙烯酯(PEN)，聚醚醚酮(PEEK)，聚酰亚胺(PI)，聚醚酰亚胺(PEI)，聚苯硫醚(PPS)，聚苯醚(PPO)，聚对苯二酰对苯二胺(例如，)，聚砜，尼龙，尼龙-12(诸如EMS AmericanGrilon公司出售的)，全氟(乙烯基丙醚)(PFA)，乙烯基乙烯醇，聚烯烃，聚苯乙烯，环氧树脂，聚偏氯乙烯(PVdC)，聚(苯乙烯-b-异丁烯-b-苯乙烯)(例如，SIBS及/或SIBS 50A)，聚碳酸脂，离聚物，生物相容聚合物，其他合适材料，或者前述材料的混合物，组合物，共聚物，聚合物/金属组合物，等等。一些实施方式中，套管可与液晶聚合物(LCP)混合。例如，混合物可含有至多为约6％的LCP。
在一些实施方式中，系统10的外表面(包括，例如，外鞘管12和内导管14的外表面)可经喷砂处理，喷珠处理，喷碳酸氢钠处理，电抛光处理等。在这些及一些其他的实施方式中，或者在外鞘管12和内导管14的一部分或系统10的其他部分上不具有鞘套的实施方式中，例如润滑，亲水、疏水的涂层，或其他类型的涂层可涂在鞘管的部分或全部上。或者，鞘套可包括润滑、亲水，保护，或其他类型的涂层。诸如氟聚合物的疏水涂层提供了干润滑性，其改善了器械操作和器械交换。润滑涂层增强了可操控性并增强了穿越病变部位的能力。在本领域中合适的润滑聚合物是公知的，可包括硅树脂等，诸如高密度聚乙烯(HDPE)，聚四氟乙烯(PTFE)，聚亚芳基氧化物，聚乙烯吡咯烷酮，聚乙烯醇，羟基烷基纤维质，藻酸钠，糖类，己内酯等的亲水聚合物，以及它们的混合物和组合。亲水聚合物可混在其中或与非水溶性化合物(包括一些聚合物)的调配量混合以形成具有合适润滑性，键合性，和溶解度的涂层。在美国专利第6,139,510号和第5,772,609号中描述了此类涂层以及用来形成此类涂层的材料和方法的一些其他的示例，通过引用的方式合并在此。
例如，可通过涂覆，挤压，共挤压，阻隔层共挤压(ILC)，或端对端地融合多段来形成涂层和/或鞘套。所述层可具有统一的刚度，或者从其近端向远端逐渐减小的刚度。通过阻隔层共挤压(ILC)逐渐减小的刚度可以是连续的，或者通过将分开的挤压管状段融合在一起逐渐减小的刚度可以是阶梯的。外层可充有不透射线的填料以方便放射成像。本领域的技术人员应当认识到，在不脱离本发明范围的情况下，这些材料能广泛地变化。
Claims (18)
1.一种医疗器械手柄，包括：
细长的手柄外壳，其具有近端、远端以及从所述近端延伸至所述远端的纵向轴线；
围绕所述手柄外壳的所述近端设置的可旋转的套管；
围绕所述可旋转的套管设置的可旋转的控制旋钮；以及
围绕所述可旋转的套管的远侧部设置的可滑动的门。
2.根据权利要求1所述的医疗器械手柄，还包括用于促动设于所述医疗器械手柄远侧的医疗器械的装置，所述装置设置在所述手柄外壳内。
3.根据权利要求1所述的医疗器械手柄，其中所述套管能围绕所述纵向轴线有选择地旋转。
4.根据权利要求1所述的医疗器械手柄，其中所述控制旋钮能围绕所述纵向轴线有选择地旋转。
5.根据权利要求1所述的医疗器械手柄，其中所述门能沿着所述纵向轴线滑动。
6.根据权利要求1所述的医疗器械手柄，其中所述套管、所述控制旋钮和所述门围绕所述纵向轴线同心地设置。
7.根据权利要求2所述的医疗器械手柄，其中所述用于促动的装置响应所述控制旋钮的旋转而纵向平移。
8.根据权利要求2所述的医疗器械手柄，其中所述用于促动的装置包括从所述纵向轴线径向向外延伸的连锁元件，所述连锁元件具有啮合形态和脱啮形态；
其中在所述啮合形态下，所述连锁元件物理地防止所述套管旋转；
其中在所述脱啮形态下，所述连锁元件允许所述套管旋转。
9.根据权利要求2所述的医疗器械手柄，其中所述门能在闭合位置和打开位置之间滑动；
其中在所述闭合位置处，所述门盖住所述套管的远侧部；
其中在所述打开位置处，所述门没有盖住所述套管的远侧部的全部。
10.根据权利要求9所述的医疗器械手柄，其中在所述打开位置处，允许所述门绕所述手柄外壳旋转。
11.根据权利要求9所述的医疗器械手柄，其中在所述闭合位置处，防止所述门绕所述手柄外壳旋转。
12.根据权利要求10所述的医疗器械手柄，其中在所述打开位置处，所述门可旋转地锁定至所述套管。
13.根据权利要求12所述的医疗器械手柄，其中所述套管包括多个在其外表面中的凹口，并且所述门包括多个从其内表面径向向内延伸的突出部；
其中所述多个突出部与所述多个凹口配合从而防止所述套管与所述门之间的相对旋转。
14.根据权利要求1所述的医疗器械手柄，其中所述套管包括围绕所述套管的中间部设置的径向延伸法兰部；
其中所述法兰部把所述控制旋钮与所述门纵向隔开。
15.根据权利要求13所述的医疗器械手柄，其中所述手柄外壳包括径向延伸的脊；
其中所述套管的远端抵靠所述脊的近侧面。
16.根据权利要求15所述的医疗器械手柄，其中在所述打开位置处，所述多个突出部抵靠所述脊的所述近侧面。
17.根据权利要求11所述的医疗器械手柄，其中所述手柄外壳包括至少一个从所述手柄外壳的外表面径向向外延伸的挡块；
其中所述门包括至少一个在其内表面中的凹槽；
其中所述至少一个凹槽配置成与所述至少一个挡块配合以防止处于所述闭合位置处的所述门旋转。
18.一种医疗器械手柄，包括：
手柄外壳；
围绕所述手柄外壳的近端可旋转地设置的管状套管；
可旋转地设置在所述管状套管的近侧部和所述手柄外壳的近端之上的端部开口的控制旋钮；
可滑动地设置在所述套管的远侧部和所述手柄外壳之上的环状门；
其中所述环状门包括多个向内延伸的突出部，其配置成与所述套管的所述远侧部中的多个凹口相配合以便所述门可旋转地锁定至所述套管。
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| US201161566615P | 2011-12-03 | 2011-12-03 | |
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| US13/688,305 | 2012-11-29 | ||
| PCT/US2012/067567 WO2013082583A1 (en) | 2011-12-03 | 2012-12-03 | Medical device handle |
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| CN104105458A true CN104105458A (zh) | 2014-10-15 |
| CN104105458B CN104105458B (zh) | 2016-05-04 |
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| US (2) | US8951243B2 (zh) |
| EP (1) | EP2785281B1 (zh) |
| JP (1) | JP2015500063A (zh) |
| CN (1) | CN104105458B (zh) |
| CA (1) | CA2858065C (zh) |
| WO (1) | WO2013082583A1 (zh) |
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Also Published As
| Publication number | Publication date |
|---|---|
| US8951243B2 (en) | 2015-02-10 |
| US20130144276A1 (en) | 2013-06-06 |
| CA2858065C (en) | 2019-01-22 |
| US20150112318A1 (en) | 2015-04-23 |
| EP2785281B1 (en) | 2020-05-20 |
| US9370421B2 (en) | 2016-06-21 |
| CA2858065A1 (en) | 2013-06-06 |
| WO2013082583A1 (en) | 2013-06-06 |
| CN104105458B (zh) | 2016-05-04 |
| JP2015500063A (ja) | 2015-01-05 |
| EP2785281A1 (en) | 2014-10-08 |
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