CN103974675A - 直连冲洗系统 - Google Patents
直连冲洗系统 Download PDFInfo
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- CN103974675A CN103974675A CN201280060924.XA CN201280060924A CN103974675A CN 103974675 A CN103974675 A CN 103974675A CN 201280060924 A CN201280060924 A CN 201280060924A CN 103974675 A CN103974675 A CN 103974675A
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- handle housing
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- outer catheter
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Classifications
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
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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
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- 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
- A61F2/95—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
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
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- 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
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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
- 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
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Surgery (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
- Endoscopes (AREA)
- Surgical Instruments (AREA)
Abstract
一种医疗装置，包括手柄壳体(18)，所述手柄壳体具有界定出内部空间的侧壁以及延伸穿过所述侧壁的近侧孔和远侧孔(129b，129a)，细长外导管，细长内部件，设于所述内部空间内并且与所述细长内部件流体连通的近侧冲洗接口(128)，设于所述内部空间内并且与所述细长外导管流体连通的远侧冲洗接口(126)。可旋转控制旋钮而使得所述远侧冲洗接口在所述内部空间内移动的控制旋钮。
Description
背景技术
一般用于心血管系统治疗的医疗器械会涉及复杂且创伤性的治疗，从而使得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的经皮治疗。因此，业界一直需求改进的小创伤心血管治疗。
发明内容
一种医疗装置，包括具有内部空间的手柄壳体，其中所述手柄壳体包括侧壁，近侧孔，和远侧孔，所述侧壁界定出所述内部空间并且从所述近侧端延伸至所述远侧端，所述近侧孔延伸穿过所述手柄壳体的侧壁至所述内部空间，所述远侧孔延伸穿过所述手柄壳体的侧壁至所述内部空间；细长外导管，其中具有从所述手柄壳体的远侧端朝远侧方向延伸的腔；细长内部件，其在所述细长外导管的腔内朝远侧方向延伸穿过所述手柄壳体的远侧端；近侧冲洗接口，其设于所述内部空间内并且与所述细长内部件流体连通；及远侧冲洗接口，其设于所述内部空间内并且与所述细长外导管的腔流体连通。
一种医疗装置，包括具有内部空间的手柄壳体，其中所述手柄壳体包括侧壁，近侧孔，和远侧孔，所述侧壁界定出所述内部空间并且从所述近侧端延伸至所述远侧端，所述近侧孔延伸穿过所述手柄壳体的侧壁至所述内部空间，所述远侧孔延伸穿过所述手柄壳体的侧壁至所述内部空间；细长外导管，其中具有从所述手柄壳体的远侧端朝远侧方向延伸的腔；细长内部件，其在所述细长外导管的腔内朝远侧方向延伸穿过所述手柄壳体的远侧端；近侧冲洗接口，其固定设于所述内部空间内并且与所述细长内部件流体连通；远侧冲洗接口，其可移动地设于所述内部空间内并且与所述细长外导管的腔流体连通；及位于所述手柄壳体的近侧端的控制旋钮；相对于所述手柄壳体旋转所述控制旋转使得所述远侧冲洗接口在所述内部空间内纵向移动。
一种医疗装置，包括手柄壳体，所述手柄壳体包括侧壁，所述侧壁包括延伸穿过其中的横向朝向的近侧孔和远侧孔；细长外导管，其中具有从所述手柄壳体的远侧端朝远侧方向延伸的腔；细长内部件，其在所述细长外导管的腔内朝远侧方向延伸穿过所述手柄壳体的远侧端；横向朝向的近侧冲洗接口，其固定设于所述手柄壳体内并且与所述细长内部件流体连通；横向朝向的远侧冲洗接口，其可移动地设于所述手柄壳体内并且与所述细长外导管流体连通；及绕所述手柄壳体的近侧端设置的控制旋钮；其中绕所述手柄壳体旋转所述控制旋转使得所述远侧冲洗接口沿平行于所述纵向轴线的方向相对于所述手柄壳体移动。
附图说明
参考附图，根据下文详细描述的本发明多种实施例，可更完整地理解本发明，其中
图1为示例性医疗装置系统的侧视图；
图2为示例性外导管的侧剖视图；
图3为沿图2中线3-3的横向剖视图；
图4为示例性内导管的侧视图；
图5为沿图4中线5-5的剖视图；
图6为沿图4中线6-6的剖视图；
图7为与示例性医疗装置系统相关的示例性植入件的一部分的立体图；
图8-11为示出植入件的示例性锁定机构的立体图；
图12为示例性套管辅助件的一部分侧视图；
图13的示例性套管辅助件与示例性植入件接合的放大平面图；
图14为示例性手柄的侧视图；
图15为示出示例性手柄的某些内部组件的剖开图；
图16-18示出了示例性手柄内的手柄组件的协调移动的例子；
图19-20示出了示例性手柄的管套的旋转；
图21-22示出了管套旋转过程中的示例性手柄内的某些组件；及
图23-25为示例性手柄内部的某些组件的局部立体示意图。
尽管可对本发明作出多种修改和代替显示，下文通过参考附图描述实施例的方式详细给出了本发明的细节。然而，应理解，本发明并不限于所描述的某个实施例。相反，本发明覆盖落入本发明的精神和范围内的所有修改，等同物，及代替物。
具体实施方式
对于下文定义的表述，除非权利要求书或说明书的其他部分给出不同的定义，否则应采用这些定义。
无论是否明示，可在本文中所有的数值前加上“约”。表述“约”一般系指本领域技术人员会认为与所引用的数值相当(即，具有相同的功能或结果)的数值范围。很多情况下，表述“约”可包括四舍五入至最接近有效数字的数字。由端点表述的数值范围包括该范围内所包含的所有数值(例如，1～5包括1，1.5，2，2.75，3，3.80，4，及5)。
如说明书和所附权利要求书中所使用的，除非上下文作出明确的相反表述，单数形式的定冠词和不定冠词包括复数形式的指代。如说明书和所附权利要求书中所使用的，除非上下文作出明确的相反表述，表述“或”一般表示“及/或”。
应参考附图阅读下文的详细描述，其中不同附图中的类似元件标有相同的标号。并非完全按比例的附图示出了示例性实施例并且不应认为用以限制本发明的范围。
全美和全世界都普遍发生影响心血管系统的疾病及/或病况。一般地，通常通过直接接触系统的受影响部分而对心血管系统进行治疗。例如，通常通过冠状动脉搭桥手术治疗一或多个冠状动脉的阻塞。应理解，此类疗法会对患者造成相当的创伤并且需要非常长的恢复时间及/或治疗。最近，已经提出了较小创伤的疗法，例如，通过经皮导管接触和治疗阻塞的冠状动脉(例如，血管成形术)。大多数病患和临床医生已经接受此类治疗。
一些相对常见的疾病包括心内的一或多个瓣膜低效，无效，或完全失效，或者其结果。例如，主动脉瓣失效可对人体造成严重影响，并且若不治疗会导致严重的疾病及/或死亡。治疗有缺陷的心脏瓣膜会带来其他的问题，例如，治疗通常要求修复或者完全置换有缺陷的瓣膜。此类疗法会给患者带来相当大的创伤。本文揭露了这样的医疗装置，即，其可用于将医疗器械传送置心血管系统的一部分以诊断，治疗，及/或修复该系统。本文所描述的医疗器械中至少有一部分可用于传送和植入置换心脏瓣膜(例如，置换主动脉瓣膜)。此外，本文所描述的装置可经皮地传送置换心脏瓣膜，并由此对患者造成较小的创伤。本文所描述的装置还可设有多个附加的有用特征并且具有下文详述的优点。
此外，图1为示例性医疗装置系统10的侧视图。应注意，简明起见，图1要么未示出要么示例性地示出系统10的某些部件。其他附图更详细的示出了关于系统10的其他组件的其他细节。系统10可用于将多种医疗器械传送及/或布置到身体内的多个位置。至少一些实施例中，系统10为可用于置换心脏瓣膜的经皮传送的置换心脏瓣膜传送系统(例如，置换主动脉瓣膜传送系统)。然而，这并作为系统10的限制，因为系统10也可用于其他干预，包括二尖瓣置换，瓣膜修复，瓣膜成形术等，或其他干预。
系统10一般描述为导管系统，其包括外鞘或导外管12以及至少部分地延伸穿过外鞘12的内导管或内管14(图1的虚线示出了其一部分)。医疗器械植入件16可连接至内导管14并且在植入件16的传送过程中设于外导管12内。手柄18设于外导管12和内导管12的近端。一般地，手柄18可配置为操控植入件16相对于内导管14的位置以及帮助布置植入件16。
使用中，系统10可经皮穿过脉管系统而前进至靠近目标区域的位置。例如，系统10可穿过脉管系统前进至靠近受损主动脉瓣膜的位置。传送过程中，植入件16一般以细长并且设为细长和没有突出的轮廓(收缩轮廓)的“传送”状态设于外导管12内。一旦定位，外导管12回缩以暴露植入件16。可致动植入件16将所述植入件扩张至大致缩短并且较大轮廓的适于植入人体的“布置”状态。当植入件16合适地布置于人体内时，状态系统10可从脉管状态系统退出，而将植入件16留在正确位置以例如用以对自体瓣膜进行合适的置换。至少某些干预中，植入件16可布置在自体瓣膜中(例如，自体瓣膜留在原来位置并且不切除)。或者，可去除自体瓣膜，并且植入件16可放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为外导管12的侧剖视图。如图2所示，外导管12具有近侧部20和远侧部22。远侧部22的内径稍稍增大或者外扩，由此提供额外的空间以将植入件16保持于其中。例如，外导管12的沿近侧部20的内径为约0.254～1.27厘米(0.10～0.50英寸)，或约0.508～1.016厘米(0.20～0.40英寸)，或约0.508～0.762厘米(0.10～0.30英寸)，或约0.56388±0.508厘米(0.222±0.002英寸)。外导管12的沿远侧部22的内径可为约0.254～1.27厘米(0.10～0.50英寸)，或约0.508～1.016厘米(0.20～0.40英寸)，或约0.508～0.762厘米(0.10～0.30英寸)，或约0.579～0.5842厘米(0.228～0.230英寸)。远侧部22的远侧端可为外扩的或具有漏斗状的远侧尖端24。漏斗状的形状增大了外导管12的位于远侧尖端24处的外径(和内径)并且有助于将植入件16插入及/或再插入外导管12中。除了在远侧尖端24处之外，外导管12的外径大致不变。例如，外导管12的外径可为约0.254～1.27厘米(0.10～0.50英寸)，或约0.508～1.016厘米(0.20～0.40英寸)，或约0.508～0.762厘米(0.20～0.30英寸)，或约0.6858厘米(0.270英寸)。上述数值仅为例子。可构思其他实施例，其具有不同尺寸(包括适用于儿童等不同体形患者)及/或外导管12具有不同的外径及/或内径设置。所构思的这些实施例包括具有外扩或者其他可变外径的外导管，具有不变内径的实施例，以及他们的组合等。外导管12的长度也可适于到达人体内的目标区域。例如，外导管12的长度可为约30～200厘米，或约60～150厘米，或约100～120厘米，或约108±0.20厘米。外导管12可为弧形。例如，外导管12的近侧段可弯曲。一实例中，曲线的半径(从外导管12的中心开始测量)可为约2～6厘米(20～60毫米)，或约3～4厘米(30～40毫米)，或约3.675厘米(36.75毫米)。同样地，这些尺寸仅是示例性的，而非用于限制本发明。
外导管12可由单个的一体式管或单体部件形成。或者，外导管12可包括多个层或部分。这些层中的一或多个可包括加固结构，例如编织物、线圈、网格，或它们的组合等。图3示出了外导管12的多层结构的例子。例如，外导管12可包括内衬或层26。内衬26上可设有中间层28。加固件30可设于中间层28上。外层32可设于加固件30上。最后，可沿外层32的多个部分或者整个外层32设置外涂层34(例如润滑涂层，亲水涂层，厌水涂层等)。上述各层仅为例子。可构思用于外导管12的若干代替结构性构造，包括具有一或多层不同于图3所示层的实施例，不带有加固件的实施例，或其他合适的结构。
用于外导管12的多个层的尺寸和材料也可为不同。例如，内层26可包括氟化乙烯丙烯(FEP)之类的聚合物材料并且厚度为约0.00254～0.0127厘米(0.001～0.005英寸)或约0.00762±0.00254(0.003±0.001英寸)，中间层28可包括聚醚嵌段酰胺(例如，PEBAX6333)之类的聚合物材料并且厚度为约0.00254～0.0127厘米(0.001～0.005英寸)或约0.005±0.00254(0.002±0.001英寸)，外涂层34可包括聚醚嵌段酰胺(例如，PEBAX7233)之类的聚合物材料并且厚度为约0.00254～0.0254厘米(0.001～0.001英寸)。一些实施例中，外涂层34可具有不同的厚度。例如，沿近侧部20，外涂层34具有较大的厚度，例如约0.0127～约0.0508厘米或约0.02159厘米(0.005英寸～0.02英寸或约0.0085英寸)，而沿远侧部22及/或远侧尖端24，涂层34的厚度可为约0.0127～约0.0508厘米或约0.01651厘米(例如，约0.005！0.02英寸或约0.0065英寸)。上述材料仅为例子，并且可使用其他合适的材料。
远侧尖端24的形式也可有变化。例如，至少某些实施例中，内衬26(即，其2.5毫米部分)可向上并且绕外导管12的远侧端(例如，绕加固件30和外层32)延伸。由55D聚醚嵌段酰胺(例如，55D PEBAX)之类合适材料制成环状部件(未示出)可设于内衬26上方并且热粘合至远侧尖端24。由此，可使得远侧尖端24的形状形成为漏斗状。
加固件30也可有多种形式。在至少一些实施例中，加固件30的形式可为编织物、线圈、网格，或它们的组合等。例如，某些实施例中，加固件30可包括金属编织物(例如，不锈钢)。所述实施例中的一些中，加固件30也可包括额外的结构，诸如一或多个纵向延伸的绳。例如，加固件30可包括设于编织物相对两侧的一对纵向延伸的芳族聚酰胺及/或对位芳族聚酰胺绳(例如，凯夫拉。可将或者不将这些绳织入编织物的某些部分或所有部分。
图4为内导管14的侧视图。内导管14的远侧端区域具有的外径台阶部40，其界定出减小的外径段42。例如，减小的外径段42的外径可为0.127～0.635厘米(0.05～0.25英寸)，或约0.254～0.508厘米(0.10～0.20英寸)，或约0.38608±0.00762厘米(0.152±0.003英寸)，相反，内径14的其余部分的外径为约0.127～约0.762厘米(0.05～0.30英寸)，或约0.254～约0.635厘米(0.10～0.25英寸)，或约0.508±0.0254(0.20±0.01英寸)。减小的外径段42可界定出系统10的其他组件附接至其上的区域。下文将描述有关这些组件的其他附加细节。
一般地，内导管14的形式可为挤出聚合物管。也可提出其他形式，包括其他聚合物管，金属管，加固管，或包括本文所述其他合适材料的类似管。一些实施例中，内导管14为单个的一体式管或单体部件形成。其他实施例中，内导管14可包括相互连接的多个部分或段。内导管的总长度可为约60～70厘米，或约100～115厘米，或约112±0.02厘米。与外导管12相同，内导管14也可被弯曲，例如，靠近其其远侧端弯曲。一些实施例中，内导管14可具有一或多个不同硬度/刚性(例如，不同的邵氏硬度计)的段。例如，内导管14可具有近侧区域44a和中间区域44b。近侧区域44a可包括大致刚性的例如72D聚醚嵌段酰胺(例如，72D PEBAX)的聚合物材料并且长度可为约60～150厘米，或约80～120厘米，或100～115厘米，或约109.5±0.02厘米。中间区域44b可包括40D聚醚嵌段酰胺(例如，40D PEBAX)并且长度可为约5～25毫米，或约10～20毫米，或约15±0.01毫米。减小的外径段42也可不同于区域44a/44b，并且一些实施例中，可包括72D聚醚嵌段酰胺(例如，72D PEBAX)并且长度为约0.5～2厘米(5～20毫米)，或约0.8～1.5厘米(8～15毫米)，或约1±0.001厘米(10±0.01毫米)。上述尺寸仅为例子。
内导管14可包括一或多个腔。例如，图5(内导管14的靠近近侧端部36的剖视图)示出了内导管14可包括第一腔46，第二腔48，第三腔50，及第四腔52。一般地，腔46/48/50/52沿内导管14的整个长度延伸。然而，可提出其他实施例，其中腔46/48/50/52中的一或多个可仅沿内导管14的一部分延伸。例如，第四腔52可在差不多要到内导管14的远侧端处停止，并且/或者填充第四腔52的远侧端以有效地终止靠近内导管14的远侧端近侧的第四腔52，如图6所示，其中不存在靠近内导管14的远侧端的第四腔。
第一腔46中可设有推拉杆84(图5中未示出，如图7等其它附图所示)，其用于扩张及/或伸长植入件16，如下文将详述。至少一些实施例中，第一腔46可衬有小摩擦衬垫54(例如，FEP衬垫)。可在第二腔48中设有销释放心轴92(图5中未示出，如图7等其它附图所示)，下文将详述。至少一些实施例中，第二腔48可衬有海波管(hypotube)衬垫56。第三腔50可为导线腔并且这一腔也可衬有海波管衬垫58。
第四腔52可用于容纳非弹力线60。非弹力线60可为多种形式。一些实施例中，非弹力线60可为不锈钢编织物的形式。非弹力线60视需要可包括一对纵向延伸的芳族聚酰胺及/或对位芳族聚酰胺绳(例如，凯夫拉)。一般地，不同于“内设于”第四腔52，非弹力线60可嵌入第四腔52中。此外，非弹力线60可延伸至靠近远侧端部38但未完全碰到内导管14的远侧端的位置，如图6所示，其中靠近内导管14的远侧端不存在第四腔52。例如，靠近内导管14的远侧端处可用聚合物材料填充第四腔52的短远侧段。
内导管14也可包括导线延伸管62，其从远侧端部38向远侧延伸。鼻锥64附接至导线延伸管62。鼻锥64一般设计为防创伤形状。鼻锥64还可包括脊66，其配置为在植入件16的传送过程中接靠外导管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件16。例如，如图所示，植入件16包括多个瓣膜小叶68(例如，牛心包)，其在杆或者连合杆72处固定至圆柱形编织物70，例如，在小叶68的连合部。这一例子中，植入件16包括通过三个杆72固定至编织物70的三个小叶68。小叶68还可固定至编织物70的底部或“远端”。柱72相应地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)。靠近柱72(例如，与柱72纵向隔开并对齐地)设有也缝合至编织物70(例如，沿编织物79的内部)的多个扣子76。这一例子中，一个扣子76附接至靠近三个柱72中各个柱的编织物70。因此，编织物70总共有三个扣子以及三个附接至其上的柱72。可构思出其他实施例，其中可使用三个以上或以下的环扣76和柱72。绕编织物70可设置密封件74(以剖面示出)，并且顾名思义，密封件74有助于将植入件16密封入目标植入位置或目标位置。
可通过使用三个指部连接件78来实现植入件16与内导管14(及/或外导管12)之间的附接。连接件78一般包括附接至内导管14(例如，围绕减小的外径段42设置并且附接至其上)圆柱形基部(未示出)。三个手指部从底部向远侧凸出，各指部配置为在柱72和环扣76处与植入件16接合。管套80可进一步帮助将这些结构保持在一起。导向件82可设于各指部的上方并且用以保持连接件78的指部与延伸靠近连接件78的推拉杆84的联合。最终，销释放组件86可为保持柱72、环扣76、和推拉杆84相互联合的联接结构。销释放组件86包括多个单独的销88，所述多个单独的销88通过螺圈连接90相互连接并且通过箍环94固定至销释放心轴92。
传送过程中，植入件16通过连接件78的指部与环扣76的突出的近侧端(并且被保持在管套80设置在所述连接之上方的适当位置)相联接的联合以及通过将推拉杆84和柱72固定在一起销88而固定至内导管14的远侧端。当植入件16在人体内前进至所需位置时，外导管12可回缩(例如，相对于内导管14朝近侧方向移动)以暴露植入件16。然后，推拉杆84可用以扩张植入件16并通过使得推拉杆84超近侧回缩以将柱72推至与扣子76接合而将植入件16“锁定”为扩张或布置状态。最终可取下销88，藉此使得推拉84与柱72分离，从而使得植入件16从系统10释放并且布置在人体中。
图8-11示出了用于系统10的锁定系统。简明起见，仅示出示例性系统10的三个指部连接件78中的一个，三个推拉杆84中的一个，以及多个杆72中的一个(并且未示出植入件16)。如图8所示，推拉杆84延伸穿过靠近指部连接件78的导向件82，穿过管套，穿过环扣76，并且进入柱72的中空t形条状部96。推拉杆84的远侧端包括可与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可弯曲穿过开口98和推拉杆84的开口。由此，将推拉杆84固定至柱72并且形成这些结构可在传送植入件16的过程中使用的状态。如应理解，柱72的近侧端和环扣76的远侧端在纵向方向上分隔，并且植入件16因此处于适于传送的细长且大致收敛轮廓的状态。
当植入件16到达人体内的预期目标位置时，医生可朝近侧方向回缩推拉杆84，藉此朝向环扣76的远侧端移动柱72的近侧端，以扩张植入件16。最终，推拉杆84可回缩的足够远以通过环扣76锁定柱72从而将植入件锁定为适于植入人体的扩张状态。图9示出了朝近侧方向回缩的推拉杆84。这样操作的过程中，柱72与环扣76形成接触。更具体地，朝近侧方向拉动t形条状部96上的抬升并且大致横向的脊部100以通过环扣76固定并且保持柱72。这一点上，能够朝向远侧方向推动推拉杆84以“解锁”植入件16，藉此运行进行再定位及/或回缩。或者，若医生满意植入件16的定位及/或锁定(例如，通过合适的成像技术观察植入件16之后)，可拉动销88(例如，从开口98以及推拉杆84中的孔中取出)以使得推拉杆84与柱72分离，如图10所示。推拉杆84的进一步回缩使得推拉杆84上的纵向定向的脊部102与管套接合并且使得管套80沿连接件78的指部朝近侧方向滑动。这样操作过程中，指部的其中形成有槽106的分叉端104暴露，并且与轨道108分离，轨道108上形成有与槽106配合的凸部110，如图11所示。此后，可从人体取出系统10，而将扩张并且布置的植入件16留在体内。
图12-13示出了所述系统可包括的另一组件。例如，图12为套管辅助件112的侧视图。如图所示，套管辅助件112包括底部114和包括三个较长瓣状部116和一对较短瓣状部118的一组瓣状部。使用中，一组瓣状部116/118可设于连接件78的各指部之间。由于连接件78总共具有三个指部，套管辅助件112可具有总共十五个瓣状部(例如，三组各包括三个“长”瓣状部116和两个“短”瓣状部118的三组，各组位于连接件78的相邻的一对指部之间)。底部114可固定至靠近连接件78的内导管14(例如在连接件78的下方并且位于连接件78与内导管14之间)。
顾名思义，套管辅助件112可有助于将植入件16套入外导管12中。此外，套管辅助件112可有助于初次套入植入件16(例如，从瓶子之类的包装容器中取出植入件16并且将植入件16推入外导管12)以及在目标区域中对植入件16进行再定位及/或回缩的过程中再次套入植入件16。可通过多个瓣状件116/118的状态和定位完成套入。例如，图13示出了较长瓣状件116与编织物70交错编织，并且较短瓣状件118沿编织物70的外部设置以作为套入漏斗。
图14为手柄18的侧视图。如图所示，手柄18包括手柄壳体120。围绕壳体120可设有可旋转的控制旋钮122(例如，位于手柄壳体120的近侧端)，可旋转控制旋钮122可用于移动系统10的一或多个组件(例如，外导管12，推拉杆84等)。可围绕手柄壳体120设置可旋转管套156。在一些实施例中也可围着可旋转套管156设置可旋转的控制旋钮122。也可绕手柄壳体120设置可滑动门124。门124可朝向远侧方向平移以暴露大致设于门124下方的可旋转管套156的远侧端(图14中未示出，图19-20等图中可见)。管套156可旋转以移动系统10的一或多个组件(例如，推拉杆84，销释放心轴92，等等)。手柄18也可包括一或多个孔129a/129b及/或用于冲洗系统10的冲洗接口126/128。一些实施例中，远侧冲洗接口126和近侧冲洗接口128设于手柄壳体120内，并且一般相对于手柄壳体120的纵向轴线横向朝向，以使得可从手柄壳体120的外部分别通过远侧孔129a和近侧孔129b抵达。图23-25更详细地示出了与冲洗接口126/128相关的系统10的其它组件。
图15为手柄18的侧视图，其中去除了手柄壳体120的一部分而暴露出内部组件的至少一部分。应注意，清楚起见，未示出手柄18内的一些组件。如图15所示，手柄壳体120包括界定出手柄壳体120的内部空间的侧壁。一些实施例中，侧壁大致围绕所示内部空间。一些实施例中，外导管12和内导管14延伸穿过手柄壳体120的远侧端。一些实施例中，接触冲洗接口128和远侧冲洗接口126可设于内部空间之内。外导管12可附接至(例如，固定附接)可沿轴线移动的导管接头130，如图15及23-25所示。导管接头130附接至拧到导螺杆134上的导管移动架132上。控制旋钮122的旋转使得导管移动架132在手柄壳体120中沿轴向移动。远侧冲洗接口126可设在导管接头130上。由此，当控制旋钮122旋转时，远侧冲洗接口126可在手柄壳体120内沿轴线及/或沿纵向移动。一般地，远侧冲洗接口126与外导管12的内部或腔流体连通，以提供至外导管12的内部或腔的通路(例如，至内导管14与外导管12之间的空间)，医生由此可在使用系统10之前利用流体冲洗外导管12的腔以去除任何不需要的材料(例如，空气，流体，污染物等)。
至少某些实施例中，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注射器之类的冲洗装置可附接至其上以进行冲洗。一些实施例中，冲洗装置(例如，注射器)可通过远侧孔129a直接连接至远侧冲洗接口126。即，冲洗装置可不通过其他干扰元件或结构(例如，管道系统和接头等)的帮助或存在而连接至远侧冲洗接口126。直接连接可减小操作过程中连接元件与手柄18内的其他组件的连接泄漏或干扰，并且可流水化整体装配医疗装置系统10。
内导管14可延伸通过导管接头130并从其朝向近侧延伸。内导管14的近侧端附接(例如，固定附接)至内部体或分流器136。分流器136的近侧端附接(例如，固定附接)至支撑体140的远侧端。分流器136和支撑体140可相对于手柄壳体120固定至适当位置。因此，内导管14可相对于手柄壳体120固定至适当位置。
一般地，分流器136及/或支撑体140可具有一或多个形成于其中的通路或腔。一些实施例中，推拉杆84及/或销释放心轴92可延伸穿过各个通路。或者，推拉杆84的近侧端及/或销释放心轴82可分别附接至轴或海波管(例如，实心截面，管状等)，并且各轴可延伸穿过一或多个通路。例如，第一轴或海波管142以及第二轴或海波管144可延伸穿过分流器136及/或支撑体140中的通路，并且一些实施例中，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。至少某些实施例中，第一轴142附接(例如，固定附接)至销释放心轴92。至少某些实施例中，第二轴144附接(例如，固定附接)至推拉杆84。应注意，系统10的至少某些实施例中，三个推拉杆84在靠近内导管14的远侧端处汇集(例如，相互接触或以其他方式相应紧密接近)并且进入第一腔46。沿其长度的一或多个位置，推拉杆84可相互附接。例如，一些实施例中，推拉杆84可在离其远侧端约10.16厘米(约4.00英寸)处焊接在一起。一些实施例中，推拉杆84可除了远侧焊接之外或者作为远侧焊接的替代，可在靠近其近侧端处焊接在一起。之后，推拉杆84可延伸至第二轴144。
海波管(例如，沿导线腔52设置的海波管衬垫58)可延伸穿过形成在其中的通路中的分流器136，然后绕分流器136和支撑体140的一部分“被分流”，并最终延伸至手柄18的近侧端处的位置，从而提供至导线腔52的用户通路。一些实施例中，支撑体140可具有多个(例如，两个或两个以上腔)纵向贯穿其中的腔141，如图25所示。近侧冲洗接口128可设于或附接至(例如，固定附接至)支撑体140，并且可与内导管14流体连通。一些实施例中，近侧冲洗接口128可与支撑体140的腔141流体连通。一些实施例中，支撑体140的腔141流体连接至分流器136及/或内导管141。近侧冲洗接口128可用于冲洗内导管14的腔141，并且例如可起与前述的远侧冲洗接口126相同的作用。
一些实施例中，导入近侧冲洗接口128的流体可流经内导管14并且从其远侧端排出。导入远侧冲洗接口126的流动可类似地流经外导管12的腔(例如，内导管14与外导管12之间的空间)并且从其远侧端排出。一般地，当从各自的远侧端排出时，导入内导管14与外导管12其中一个的流体不会进入其中另一个的内部或腔(例如，导入内导管14的流体不会进入外导管12的腔)。
通过多种紧固件或附接机构，近侧冲洗接口128可附接至支撑体140，并且远侧冲洗接口可附接至导管接头130。例如，冲洗接口126/128可通过延伸穿过形成在冲洗接口126/128上的凸缘而保持在导管接头130及/或支撑体140内。一些实施例中，冲洗接口126/128可以螺纹拧入导管接头130及/或支撑体140中的位置。一些实施例中，冲洗接口126/128可通过卡扣配合、压入配合，或过赢配合附接至导管接头130及/或支撑体140。一些实施例中，可加入粘合剂以密封连接从而防止泄露。一些实施例中，相邻组件之间可使用O形环或其他压缩密封件。
第一轴142的近侧端固定至滑动件146，而第二轴144的近侧端固定至力限制器体150。各种组件之间的连接包括多个不同类型的连接，例如机械结合(例如，销连接，螺纹连接，过赢配合等)，粘合剂结合，热结合等。滑动件146可相对于力限制器体150滑动。一些实施例中，滑动件146可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之间的相互移动。力限制器体150可固定至拧到丝杠134上的推拉杆移动架152。由此，丝杠134的移动可使得推拉杆移动架152和力限制器体150移动，并且由此使得推拉杆84(通过第二轴144)移动。本文还记载这一运动的一些其他细节。
一般地，力限制器体150形成或界止动点，其为使用者提供触觉反馈(例如，阻止控制旋钮122进一步旋转)以告知推拉杆朝近侧的回缩距离已经足以用环扣76锁定柱72。为了验证正确的锁定，医生可使用适当的可视技术以呈现正确锁定(例如，柱72和环扣76的相对定位)。楔块148可靠近滑动件146以可选择地将滑动件146锁定至力限制器体150。为了使得销释放心轴92可朝近侧回缩以推动销88，楔块148可旋转或以其他方式移动至二级位置或状态。当处于这一状态时，楔块148例如不再形成滑动件146和销释放心轴92的进一步移动的阻挡物。因此，由于楔块148不再形成阻挡，滑动件146和销释放心轴92可朝近侧回缩，从而通过使得能够拉动销88而有助于植入件16的布置。
手柄18还包括可旋转环155，其内齿配置为与连接至导螺杆134的齿轮157上的齿啮合。环155连接至控制旋钮122，由此控制旋钮122的旋转使得环155进行类似运动并随之使得导螺杆134进行类似运动。
手柄18一般配置为协调系统10的多个结构的移动。例如，手柄18配置为使得使用者可移动外导管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配置为在干预过程中可在适当的时机移动适当的结构，从而高效地传送植入件16。手柄18使得系统10协调动作的一些例子类似于第US 2010/0280495号美国专利申请公开，通过引用的方式将其全部内容合并在此。
为了便于促进协调动作，手柄18可包括空动筒158，空动筒158配置为在干预过程中的不同时机与移动架132/152或和移动架132/152相关联的螺钉接合，以停止运动(例如，形成适当移动架的“无效运动”)。图16-19示出了由手柄18达成的一些协调运动。应注意，清楚起见，图16-20省略了系统10的某些元件。例如，图16示出了外导管12相对于内导管14(以及手柄18)向远侧方向移动以将植入件16完全套入其中时手柄18所处的第一位置或状态。当处于这一位置时，导管移动架132的位置靠近手柄18的远侧端。此外，与推拉杆移动架152相关的杆螺钉(rod screw)152a从推拉杆移动架152朝远侧方向延伸并且定位在空动筒158之内。控制旋钮122旋转时(例如，沿顺时针方向)，丝杠134开始旋转。丝杠134的旋转使得导管移动架132朝向近侧沿丝杠134移动，从而使得外导管12朝向近侧移动(例如，使得植入件16“脱出”)。丝杠134的这一初始旋转也使得杆螺钉152a旋转。造成这一情况的原因例如可为杆螺钉152a上的旋钮或凸部(未示出)可与沿空动筒158内部设置螺旋螺纹啮合。然而，由于杆螺钉152a与推拉杆移动架152相隔开，就不会将力作用到推拉杆移动架152上。由此，控制旋钮122的初始运动不会造成推拉杆移动架152的移动，而是仅造成导管移动架132的平移以及杆螺钉152a的旋转(及平移)。
最终，杆螺钉152a(例如，形成于其中的旋钮)到达形成在空动筒158的端部处的大致直线形的螺纹或通路。直线螺纹使得杆螺钉152a沿丝杠134平移至杆螺钉152a接触(例如，拧入其中并且接靠)推拉杆移动架152。这样操作的过程中，杆螺钉152a可接触并且使得推拉杆移动架152朝向近侧移动。因此，丝杠134的进一步旋转不仅使得导管移动架132朝向近侧移动，而使得推拉杆移动架152朝向近侧移动，如图17所示。
当套管移动架132到达空动筒158时，导管移动架132的导管移动架螺钉132a进入空动筒158，如图18所示。这一运动方式与杆螺钉152a拧入和拧出沿空动筒158形成的螺旋螺纹相类似。例如，当导管移动架132平移时，导管移动架螺钉132可跟随沿着或者靠近空动筒158形成的大致直线的螺纹或通路。当到达空动筒158时，导管移动架螺钉132a(例如，形成于其上的旋钮或凸部)可切换为与空动筒158的螺旋螺纹啮合并且旋转。这一旋转使得导管移动架螺钉132a从导管移动架132中“拧出”。因此，丝杠134的额外运动导致推拉杆移动架152朝向近侧连续运动同时使得导管移动架132停止运动。
至少一些实施例中，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。由此，移动架132/152可沿丝杠134以不同速率行进。例如，导管移动架132沿其平移的丝杠134的节距可大致比靠近推拉杆移动架152的位置有更大的间隔距离或更倾斜。由此，移动架132/152的协调动作也可设置为使得导管移动架132以比推拉杆移动架152更快的速率平移。也可提出具有与上述结构相反的方式，以及其中丝杠134具有基本不变节距或者包括多个不同节距区域的其它构造。
推拉杆移动架152充分的近侧向回缩(例如，如图18所示)使得推拉杆84充分回缩以使得可利用环扣76接合并且锁定柱72。当医生满意而锁定完成时(例如，通过适当的可视化技术检查之后)，还可朝近侧回缩销释放心轴92以从开口98和推拉杆84中的开口拉动销88以释放植入件16。
为了开始释放销88，门124可沿管套156(位于手柄18上)朝远侧滑动，如图19所示。当门124充分前进时，门124和管套156一起旋转，如图20所示。推拉杆移动架152还可包括径向延伸的近侧突起部件164。一般地，突起部件164可设计为防止管套156过早发生旋转(并由此防止销过早被拉出)的部件。例如，突起部件164可位于槽(未示出)内并且沿管套156的内部跟随所述槽。当定位在到内时，突起部件164大致形成防止管套156相对于手柄壳体120旋转的物理障碍物。当推拉杆移动架152朝近侧平移至手柄壳体120的后部时(例如，当推拉杆84朝近侧回缩以利用环扣76锁定柱72时)，突起部件164离开管套156中的槽。因此，突起部件164不再阻碍管套156的旋转，由此管套156此时可旋转以拉出销88。
管套156通过环154与齿轮160联动，齿轮160与二级螺钉162啮合。管套156的近侧端处的缺口啮合环154上的凸部，由此管套156的旋转使得环154并随之使得二级螺钉162发生相应的旋转。
管套156的初始旋转足以使得楔块148旋转(例如，通过管套156与楔块148之间使得楔块148切换的机械连接)从第一状态旋转至第二状态以朝近侧回缩并且拉动销88(例如，通过销释放心轴92)，所述第一状态中，可选择地将滑动件146(并由此使得销释放心轴92)锁定至力限制器体150，所述第二状态中，运行滑动块146随着二级螺钉162旋转而沿第二螺钉162旋转。如图21所示，处于第一状态的楔块148沿力限制器体150的顶部与脊部158接合，所述力限制器体150形成防止滑动件146相对于力限制器体150朝近侧平移的物理障碍物。当管套156旋转而将楔块148切换为第二状态时，随着管套156绕手柄壳体120旋转以从开口98和推拉杆84的远侧端的开口拉出销88时，滑动件146可在设于力限制器体150的顶部的槽166内朝近侧平移(例如，如图22所示)。一旦已经取出销88，推拉杆84可从植入件16退回，藉此将植入件布置在目标位置。
在布置完植入件16之后，控制旋钮122可旋转以使得导管移动架132在手柄壳体120内朝远侧移动，藉此使得外导管12相对于内导管14和三指部连接件78朝向远侧移动，以覆盖或者再次套入系统10的设于远侧端的组件。此后，可从患者体内取出系统10。
可用于本文所述的系统10(及/或本文所述的壳体系统)的各种组件和各种管状部件可包括医疗装置通用的材料。简明起见，下文根据外导管12及/或内导管14描述。然而，这并非意图限制本文所述的装置和方法，本文的描述可应用于与本文所述类似管状部件及/或管状部件或装置的组件。
外导管12及/或内导管14可由金属，金属合金，聚合物(下文将描述一些聚合物的例子)，金属-聚合物组合物，陶瓷，或其组合等，或者其他合适材料。合适金属和金属合金的一些例子包括304V，304L，和316LV不锈钢之类的不锈钢；软钢；线弹性及/或超弹性镍诺钛之类的镍-钛合金；镍-铬-钼合金(例如，625之类的UNS:N06625，之类的UNS:N06022，之类的UNS:N10276，其他合金等)，镍-铜合金(例如，400，400，400之类的UNS:N04400等)，镍-钴-铬-钼合金(例如，之类的UNS:R30035等)，镍-钼合金(例如，之类的NS: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-钨合金或钨合金等之类的其他镍合金；钴-铬合金；钴-铬-钼合金(例如，之类的UNS:R30003等)；铂富集不锈钢；钛；前述组合；等等；或者任何其他合适的材料。
如本文所述，在市售镍-钛或镍诺钛合金的家族里，有所谓的“线弹性”或“非超弹性”种类，其呈现出具有独特而有利的机械特性，尽管其化学性质与现有的形状记忆和超弹性变种类似。线弹性及/或非超弹性镍诺钛与超弹性镍诺钛的区别在于，线弹性及/或非超弹性镍诺钛的应力/张力曲线中不具有实质的“超弹平台区”或“旗区域”，而超弹性镍诺钛则具有。相反，在线弹性及/或非超弹性镍诺钛中，随着可恢复的张力增大，应力大致线性地或某种程度上不必完全线性地连续增大直至塑性变形开始或，或者以比超弹镍诺钛所示的超弹平台及/或旗区域更为线性的关系增大。由此，为了公开的目的，线弹性及/或非超弹性镍诺钛也可称为“大致”线性的弹性弹性及/或非超弹性镍诺钛。
某些情况中，线弹性及/或非超弹性镍诺钛与超弹镍诺钛的区别在于线弹性及/或非超弹性镍诺钛可承受至多约2-5％的张力而保持大致的弹性(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约8％的张力。这两种材料与不锈钢之类的其他线弹材料(也根据成分不同而有所区别)的区别在于，其他线弹材料在塑性变形之前可仅可承受约0.2～0.44％的张力。
某些实施例中，线弹性及/或非超弹性镍钛合金为不具有任何可由差示扫描量热法(DSC)和动态金属热分析(DMTA)在较大温度范围进行分析而测得的马氏体相变/奥氏体相变的合金。例如，一些实施例中，在约-60摄氏度℃～约120℃的范围内未测得线弹性及/或非超弹性镍钛合金的马氏体相变/奥氏体相变。因此，此类材料的机械结合特性一般这一非常广泛的温度范围内不会因温度而收到影响。一些实施例中，环境温度或室温下与体温下线弹性及/或非超弹性镍钛合金的机械结合特性基本相同，例如表现为都不具有超弹平台及/或旗区域。换言之，在广泛的温度范围内，线弹性及/或非超弹性镍钛合金保持其线弹性及/或非超弹性特征及/或特性。
一些实施例中，线弹性及/或非超弹性镍钛合金可为约50～约60质量百分比的镍，其余部分基本为钛。一些实施例中，成分为约54～约57质量百分比的镍，其余部分基本为钛。镍钛合金的合适例子为日本神奈川的谷河技术材料有限公司出售的FHP-NT合金，第5,238,004号和第6,508,803号美国专利描述了一些镍钛合金的例子，通过引用将其合并在此。其他的合适材料包括ULTANIUMTM(由Neo-Metrics公司出售)和GUM METALTM(丰田公司出售)。一些其他实施例中，超弹性合金(例如超弹性镍诺钛)可用于获得需要的特性。
至少一些实施例中，外导管12和内导管14的一些部分或所有部分可掺杂有，材料为，或以其他方式包括不透辐射材料。不透辐射材料系指，能够在医疗过程中在荧光透视屏或其他成像技术产生相对较亮的图形。这一相对较亮图形可帮助系统10的使用者判定其位置。不透辐射材料的一些例子包括但不限于，金，铂，钯，钽合金，装有不透辐射填料的聚合物材料等。此外，也可在系统10的设计中结合入其他不透辐射标记带及/或线圈，以得到相同结果。
一些实施例中，系统10可与磁共振成像(MRI)有一定的兼容性。例如，外导管12和内导管14(或其部分)可由基本不干扰图像以及生成实质伪影(即，图像中的间隙)的材料制成。例如，某些铁磁材料可能不适用，以为会在MRI图像中生成伪影。外导管12和内导管14(或其部分)也可有MRI机器可成像的材料制成。一些具有这些特性的材料例如包括钨，钴-铬-钼合金(例如，之类的UNS:R30003等)，镍-钴-铬-钼合金(例如，之类的UNS:R30035等)，镍诺钛等，或其他材料。
外导管12和内导管14的一部分或者所有部分可设置套管或罩子(未示出)，以界定出系统10的大致平滑的外表面。然而，其他实施例中，可系统10的一部分可不具有此类套管或罩子，从而外导管12和内导管14可形成外表面。套管可由聚合物或其他合适材料制成。一些合适的聚合物例子可包括聚四氟乙烯(PTFE)，乙烯四氟乙烯(ETFE)，氟化乙烯丙烯(FEP)，聚氧甲烯(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)邻苯二甲酸酯及/或杜邦公司出售的之类的聚酯弹性体)，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，凯夫拉)，聚砜，尼龙，尼龙-12(例如EMS American Grilon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SIBS50A)，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。一些实施例中，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。
一些实施例中，系统10的外表面(例如包括，外导管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。这些及其他实施例中，或者在外导管12和内导管14或者系统10的其他部分不具有套管的实施例中，例如可在导管的一些部分或所有部分上涂覆润滑涂层、亲水涂层，保护涂层，或其他类型的涂层。或者，所述套管可包括润滑涂层、亲水涂层，保护涂层，或其他类型的涂层。氟聚合物之类的厌水涂层可提供干润滑性，其可增强对装置的拿握和交换。润滑涂层可增强操控性并且增强通过损伤处的能力。合适的润滑聚合物系业界工质，并且可包括硅树脂等，高密度聚乙烯(HDPE)，聚四氟乙烯(PTFE)，聚芳醚，聚烯吡酮，聚乙烯醇，羟基烷基纤维质，糖类，己内酯等之类的亲水聚合物，或者它们的混合和组合。亲水聚合物可相互混合物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度，键合度，和溶解度的涂层。第6,139,510号和第5,772,609号美国专利描述了此类涂层的其他例子以及用于形成此类涂层材料及方法的一些其他例子，通过引用的方式合并在此。
例如，可通过涂覆，挤压，共挤压，阻断层共挤压(ILC)，或端对端地融合多个段等方法形成涂层及/或套管。所述层可具有统一的刚性，或者刚性随着从其近侧段朝向远侧段逐渐减小。通过ILC形成可达成连续的刚性逐渐减小，而通过将独立的挤出成型管状段融合在一起则可达成阶段性的刚性逐渐减小。可使用不透辐射材料涂覆外层，以方便放射成像。本领域的技术人员应认识到，这些材料可有许多种变化而不脱离本发明的范围。
Claims (20)
1.一种医疗装置，包括：
手柄壳体，其具有近侧端、远侧端、从所述近侧端延伸至所述远侧端的纵向轴线以及位于其内的内部空间；
其中所述手柄壳体包括界定出所述内部空间并且从所述近侧端延伸至所述远侧端的侧壁、延伸穿过所述手柄壳体的侧壁至所述内部空间的近侧孔、以及延伸穿过所述手柄壳体的侧壁至所述内部空间的远侧孔；
细长外导管，其具有从所述手柄壳体的远侧端朝远侧方向延伸的腔；
细长内部件，其在所述细长外导管的腔内穿过所述手柄壳体的远侧端朝远侧方向延伸；
近侧冲洗接口，其设于所述内部空间内并且与所述细长内部件流体连通；及
远侧冲洗接口，其设于所述内部空间内并且与所述细长外导管的腔流体连通。
2.如权利要求1所述的医疗装置，还包括导管接头，其设于所述内部空间内并且在所述内部空间内轴向可移动；
其中所述远侧冲洗接口附接至所述导管接头。
3.如权利要求2所述的医疗装置，其中所述细长外导管固定至所述导管接头并且从所述导管接头朝远侧方向延伸。
4.如权利要求2所述的医疗装置，其中所述细长内部件朝远侧方向延伸穿过所述导管接头并且进入所述细长外导管的腔。
5.如权利要求1所述的医疗装置，其中所述远侧冲洗接口配置为通过所述远侧孔从所述手柄壳体的外部可直接通到所述远侧冲洗接口。
6.如权利要求1所述的医疗装置，其中所述近侧冲洗接口配置为通过所述近侧孔从所述手柄壳体的外部可直接通到所述近侧冲洗接口。
7.如权利要求1所述的医疗装置，其中所述细长内部件相对于所述手柄壳体固定至适当位置。
8.如权利要求1所述的医疗装置，其中所述细长外导管相对于所述手柄壳体可轴向移动。
9.如权利要求1所述的医疗装置，其中所述细长内部件包括至少三个纵向延伸穿过所述细长内部件的腔。
10.如权利要求1所述的医疗装置，还包括分流器和固定附接至所述分流器的近侧端的支撑体；
其中所述分流器和所述支撑体相对于所述手柄壳体固定至适当位置；
其中所述近侧冲洗接口附接至所述支撑体。
11.如权利要求10所述的医疗装置，其中所述细长内部件固定至所述分流器并且从所述分流器朝向远侧方向延伸。
12.如权利要求10所述的医疗装置，其中所述支撑体包括两个纵向延伸穿过所述支撑体的腔。
13.如权利要求12所述的医疗装置，其中所述近侧冲洗接口与所述支撑体的所述两个腔流体连通。
14.如权利要求13所述的医疗装置，其中所述细长内部件包括至少三个纵向延伸穿过所述细长内部件的腔；
其中所述细长内部件的所述至少三个腔中的至少两个腔与所述近侧冲洗接口流体连通。
15.一种医疗装置，包括：
手柄壳体，其具有近侧端、远侧端、从所述近侧端延伸至所述远侧端的纵向轴线以及位于其内的内部空间；
其中所述手柄壳体包括界定出所述内部空间并且从所述近侧端延伸至所述远侧端侧壁、延伸穿过所述手柄壳体的侧壁至所述内部空间的近侧孔以及延伸穿过所述手柄壳体的侧壁至所述内部空间的远侧孔；
细长外导管，其中具有从所述手柄壳体的远侧端朝远侧方向延伸的腔；
细长内部件，其在所述细长外导管的腔内朝远侧方向延伸穿过所述手柄壳体的远侧端；
近侧冲洗接口，其固定地设于所述内部空间内并且与所述细长内部件流体连通；
远侧冲洗接口，其可移动地设于所述内部空间内并且与所述细长外导管的腔流体连通；及
位于所述手柄壳体的近侧端的控制旋钮；
其中相对于所述手柄壳体旋转所述控制旋钮使得所述远侧冲洗接口在所述内部空间内纵向移动。
16.如权利要求15所述的医疗装置，其中所述细长外导管相对于所述远侧冲洗接口固定至适当位置。
17.如权利要求15所述的医疗装置，其中所述细长内部件相对于所述近侧冲洗接口固定至适当位置。
18.如权利要求15所述的医疗装置，其中导入所述近侧冲洗接口的流体流经所述细长内部件而不进入所述细长外导管的腔。
19.如权利要求15所述的医疗装置，其中导入所述远侧冲洗接口的流体流经所述细长外导管的腔而不进入所述细长内部件。
20.一种医疗装置，包括：
手柄壳体，其具有近侧端、远侧端以及从所述近侧端延伸至所述远侧端的纵向轴线；
其中所述手柄壳体包括侧壁，所述侧壁包括延伸穿过其中的横向朝向的近侧孔和远侧孔；
细长外导管，其中具有从所述手柄壳体的远侧端朝远侧方向延伸的腔；
细长内部件，其在所述细长外导管的腔内朝远侧方向延伸穿过所述手柄壳体的远侧端；
横向朝向的近侧冲洗接口，其固定设于所述手柄壳体内并且与所述细长内部件流体连通；
横向朝向的远侧冲洗接口，其可移动地设于所述手柄壳体内并且与所述细长外导管的腔流体连通；及
围绕所述手柄壳体的近侧端设置的控制旋钮；
其中相对所述手柄壳体旋转所述控制旋钮使得所述远侧冲洗接口沿平行于所述纵向轴线的方向相对于所述手柄壳体移动。
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| WO2023179278A1 (zh) * | 2022-03-24 | 2023-09-28 | 上海纽脉医疗科技股份有限公司 | 一种用于将人工假体植入患者体内的输送系统 |
Also Published As
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| US20130123757A1 (en) | 2013-05-16 |
| JP2014533173A (ja) | 2014-12-11 |
| WO2013070569A1 (en) | 2013-05-16 |
| US9131926B2 (en) | 2015-09-15 |
| EP2775962A1 (en) | 2014-09-17 |
| CN103974675B (zh) | 2016-12-07 |
| US20150359997A1 (en) | 2015-12-17 |
| CA2855194C (en) | 2019-02-26 |
| EP2775962B1 (en) | 2018-01-10 |
| US9555219B2 (en) | 2017-01-31 |
| CA2855194A1 (en) | 2013-05-16 |
| EP3335672A3 (en) | 2018-09-19 |
| EP3335672A2 (en) | 2018-06-20 |
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