相关申请的引用Citation of Related Applications
本申请要求2011年4月15日提交的美国临时申请第61/476,236号的优先权，通过引用的方式将该申请整体并入本文。This application claims priority to U.S. Provisional Application No. 61/476,236, filed April 15, 2011, which is incorporated herein by reference in its entirety.
技术领域Technical Field
本申请的多个实施方案涉及缝合装置和方法。本申请的某些实施方案涉及用于缝合解剖学瓣的缝合装置和方法，所述解剖学瓣例如心脏瓣膜，例如二尖瓣、主动脉瓣、三尖瓣或肺动脉瓣。Various embodiments of the present application are directed to suturing devices and methods. Certain embodiments of the present application are directed to suturing devices and methods for suturing anatomical valves, such as heart valves, such as mitral valves, aortic valves, tricuspid valves, or pulmonary valves.
背景技术Background Art
医疗工作者常常使用缝合线来闭合人体中不同位置的各种开口，例如切割口、穿刺口以及切除口。通常，缝合线便于良好地使用和发挥功能，从而保持住通过其闭合的生物组织的开口，以助于凝血、愈合以及防止形成瘢痕。Medical practitioners often use sutures to close various openings in different locations in the human body, such as incisions, punctures, and excisions. Generally, sutures are easy to use and function well, thereby maintaining the opening of the biological tissue closed by them to help coagulation, healing, and prevent scar formation.
在一些情况下，利用常规缝合线和缝合方法来闭合开口是不可行的。另外，在一些情况下，利用常规缝合线和缝合方法需要侵袭性操作，这使得患者有感染、延迟复原、疼痛增加以及其他并发症的风险。In some cases, it is not feasible to close the opening using conventional sutures and suturing methods. Additionally, in some cases, invasive procedures are required using conventional sutures and suturing methods, which can lead to infection, delayed recovery, increased pain, and other complications in the patient.
某些心脏瓣膜可能变弱或拉伸了，或者可能具有导致其不能正确闭合的其他结构缺陷，例如先天性缺陷，这可能导致血流与正常流动方向相反。这种情况称为回流、功能不全或功能缺少，这可以减少沿正常方向的血流。回流导致心脏工作强度增加，从而补偿通过这些瓣的血液回流，这可能导致心脏扩大，这会降低心脏性能。虽然三尖瓣和肺动脉瓣也可以出现这种情况，但二尖瓣和主动脉瓣出现这种情况的频率更高。Certain heart valves may be weakened or stretched, or may have other structural defects that prevent them from closing properly, such as congenital defects, which can cause blood to flow in the opposite direction of its normal flow. This condition, called regurgitation, insufficiency, or lack of function, can reduce blood flow in the normal direction. Regurgitation causes the heart to work harder to compensate for the backward flow of blood through these valves, which can cause the heart to enlarge, which can reduce heart performance. This condition occurs more frequently with the mitral and aortic valves, although it can also occur with the tricuspid and pulmonary valves.
已经开发出了多种方法来修复不能正确闭合的瓣。其中包括Alfieri(阿尔菲里)技术，有时称为缘至缘修复，其涉及缝合瓣叶的边缘并将瓣叶拉得更近。在另一种技术中，置换或缩短腱索。有时，将补丁施加到具有开口的瓣叶。在一些情况下，通过去除待处理的瓣叶部分并将瓣叶的周围部分缝合，对瓣叶再塑形。通过在功能失常的瓣的周围附接环来处理某些瓣。在二尖瓣瓣膜成形术中，例如，可以将环状或部分环状的装置植入二尖瓣的周围，从而将瓣叶拉在一起。缝合线可用于将瓣膜成形术环连接至瓣的基部。可以用生物或机械替换品置换其他瓣。这些方法常常是通过高侵袭性操作实施的，有时需要打开患者的胸腔，使患者心脏停止工作并通过心肺机通过血流。机器人辅助的操作已被用于减小这些操作所需的开口的大小。Several methods have been developed to repair valves that don't close properly. These include the Alfieri technique, sometimes called an edge-to-edge repair, which involves suturing the edges of the leaflets and pulling them closer together. In another technique, the chordae tendineae are replaced or shortened. Sometimes, a patch is applied to the leaflets that have an opening. In some cases, the leaflets are reshaped by removing the portion of the leaflet to be treated and suturing the surrounding portion of the leaflet. Some valves are treated by attaching a ring around the malfunctioning valve. In mitral annuloplasty, for example, a ring-shaped or partially ring-shaped device can be implanted around the mitral valve to pull the leaflets together. Sutures can be used to connect the annuloplasty ring to the base of the valve. Other valves can be replaced with biological or mechanical replacements. These methods are often performed through highly invasive procedures that sometimes require opening the patient's chest, stopping the patient's heart, and passing blood through a heart-lung machine. Robotic-assisted procedures have been used to reduce the size of the openings required for these procedures.
发明内容Summary of the Invention
本文公开了用于缝合生物组织的缝合装置和方法的实施方案。所述缝合装置及其使用方法可以用于多种操作中，例如处理(例如，闭合)创伤和天然形成的或手术制造的孔或通道。例如，所述缝合装置可以用于处理解剖学瓣，例如心脏瓣膜，包括可能变弱或拉伸或者具有导致其不能正确闭合的其他结构缺陷(例如先天性缺陷)的心脏瓣膜。在一些实施方案中，一个或多个缝合装置可以用于处理或修复瓣，例如三尖瓣、肺动脉瓣、二尖瓣以及主动脉瓣。在一些实施方案中，一个或多个缝合装置可以用于实施多种操作，例如缘至缘修复(类似于Alfieri技术)、瓣膜成形术(利用或不利用环或其他植入物)、心室空间缝合、腱索缝合、心脏中其他位置的缝合、腱索置换、腱索缩短、施加补丁、瓣叶再成形以及修补物附接，例如环和生物学或机械置换瓣。Disclosed herein are embodiments of suturing devices and methods for suturing biological tissue. The suturing devices and methods of use thereof can be used in a variety of operations, such as treating (e.g., closing) wounds and naturally formed or surgically created holes or channels. For example, the suturing devices can be used to treat anatomical valves, such as heart valves, including heart valves that may be weakened or stretched or have other structural defects (e.g., congenital defects) that cause them to not close properly. In some embodiments, one or more suturing devices can be used to treat or repair valves, such as tricuspid valves, pulmonary valves, mitral valves, and aortic valves. In some embodiments, one or more suturing devices can be used to perform a variety of operations, such as edge-to-edge repair (similar to the Alfieri technique), valvuloplasty (with or without rings or other implants), ventricular space suturing, chordal suturing, suturing of other locations in the heart, chordal replacement, chordal shortening, patch application, leaflet reshaping, and prosthetic attachment, such as rings and biological or mechanical replacement valves.
在一些实施方案中，所述缝合装置可以用于闭合或缩小身体中多种其他组织开口、腔、中空器官或天然的或手术制造的通道。在一些实施方案中，所述缝合装置可以用于缝合身体中的修补物、合成材料或可植入装置。例如，所述装置可以用于缝合身体中的填料(pledget)。In some embodiments, the suturing device can be used to close or reduce a variety of other tissue openings, cavities, hollow organs, or natural or surgically created passages in the body. In some embodiments, the suturing device can be used to suturing a prosthesis, synthetic material, or implantable device in the body. For example, the device can be used to suturing a pledget in the body.
在一些实施方案中，缝合装置可以包括具有远端的长形体、单个臂、针以及保护构件。单个臂可以在长形体的远端与长形体连接，臂能在缩回位置和伸出位置之间运动。臂可以包括第一缝合线座架，其位于臂的自由端附近并被配置为能可释放地保持第一缝合线部分。针可以被配置为能在缩回位置和展开位置之间运动，从而当第一针从缩回位置运动至前进位置并返回缩回位置时，能收回第一缝合线座架中保持的第一缝合线部分。第一保护构件可以被配置为能在第一针从其缩回位置朝向其展开位置运动的至少部分过程中，限制第一针针的远端和周围组织之间的接触。In some embodiments, the suturing device may include an elongated body having a distal end, a single arm, a needle, and a protective member. The single arm may be connected to the elongated body at the distal end of the elongated body, and the arm may be movable between a retracted position and an extended position. The arm may include a first suture holder, which is located near the free end of the arm and is configured to releasably hold the first suture portion. The needle may be configured to move between a retracted position and an extended position, so that when the first needle moves from the retracted position to the advanced position and back to the retracted position, the first suture portion held in the first suture holder can be retracted. The first protective member may be configured to limit contact between the distal end of the first needle and the surrounding tissue during at least a portion of the movement of the first needle from its retracted position toward its extended position.
在一些实施方案中，缝合装置可以包括具有近端和远端的长形体以及位于所述近端的手柄。第一臂和第二臂可以在所述远端连接至长形体，并且第一臂和第二臂可以被配置为能在第一位置和第二位置之间运动，在第一位置时，第一臂和第二臂被收入长形体内，在第二位置时，第一臂和第二臂具有伸出并远离长形体的自由端。第一臂和第二臂可以彼此之间形成角，并且可以每个臂在在其自由端具有至少一个缝合线座架。缝合线座架可以被配置为能可释放地保持缝合线部分。针臂可以连接至长形体，位于第一臂和第二臂的近侧，并且可以从缩回位置伸出至伸出位置，在缩回位置时，针臂被收入长形体，在伸出位置时，述针臂从长形体向远侧并向外侧伸出。针臂可以绕长形体、至少在第一位置和第二位置之间转动，在第一位置时，针臂对准第一臂的自由端，在第二位置时，针臂对准第二臂的自由端。该装置还可以包括第一针和第二针，第一针和第二针可以具有缩回位置，在缩回位置时，每个针的远点位于针臂内。第一针可以从缩回位置运动至展开位置，在展开位置时，当针臂处于第一位置时，第一针的远点伸出针臂、进入第一臂的缝合线座架。第二针可以从缩回位置运动至展开位置，在展开位置时，当针臂处于第二位置时，第二针的远点伸出针臂、进入第二臂的缝合线座架。In some embodiments, the suturing device may include an elongated body having a proximal end and a distal end and a handle located at the proximal end. A first arm and a second arm may be connected to the elongated body at the distal end, and the first arm and the second arm may be configured to move between a first position and a second position, wherein in the first position, the first arm and the second arm are retracted into the elongated body, and in the second position, the first arm and the second arm have free ends extending away from the elongated body. The first arm and the second arm may form an angle with each other, and each arm may have at least one suture holder at its free end. The suture holder may be configured to releasably hold a suture portion. A needle arm may be connected to the elongated body, located proximal to the first arm and the second arm, and may extend from a retracted position to an extended position, wherein in the retracted position, the needle arm is retracted into the elongated body, and in the extended position, the needle arm extends distally and outwardly from the elongated body. The needle arm may rotate around the elongated body, at least between a first position and a second position, wherein in the first position, the needle arm is aligned with the free end of the first arm, and in the second position, the needle arm is aligned with the free end of the second arm. The device may further include a first needle and a second needle, wherein the first needle and the second needle may have a retracted position in which a distal point of each needle is located within the needle arm. The first needle may be movable from the retracted position to an extended position in which, when the needle arm is in the first position, the distal point of the first needle extends out of the needle arm and into the suture holder of the first arm. The second needle may be movable from the retracted position to an extended position in which, when the needle arm is in the second position, the distal point of the second needle extends out of the needle arm and into the suture holder of the second arm.
还描述了缝合解剖学瓣的方法。在一些实施方案中，可以将长形体至少部分地位于解剖学瓣内。可以使臂从所述长形体展开，第一臂可释放地保持第一缝合线部分。可以使臂的自由端位于或邻近瓣的基部。可以使第一针从长形体展开，使得第一针在第一位置穿透瓣并接合第一缝合线部分。可以在第一针被展开至第一位置时，保护瓣的组织和周围解剖学结构免受第一针的远端的损伤。可以将第一缝合线部分拉过瓣叶。可以使第二缝合线部分在第二位置通过瓣。可以将第一和第二缝合线部分牢固地保持在一起。Also described is a method for suturing an anatomical flap. In some embodiments, an elongated body can be positioned at least partially within an anatomical flap. An arm can be deployed from the elongated body, the first arm releasably holding a first suture portion. The free ends of the arms can be positioned at or adjacent to the base of the flap. A first needle can be deployed from the elongated body such that the first needle penetrates the flap and engages the first suture portion at a first position. Tissue and surrounding anatomical structures of the flap can be protected from damage by the distal end of the first needle while the first needle is deployed to the first position. The first suture portion can be pulled through the leaflet. A second suture portion can be passed through the flap at a second position. The first and second suture portions can be securely held together.
在一些实施方案中，可以通过以下步骤缝合解剖学瓣：将长形体至少部分地置于解剖学瓣中，使臂从长形体在瓣的第一侧展开，第一臂可释放地保持第一和第二缝合线部分。可以使臂的自由端臂位于或邻近瓣的基部。可以使第一和第二针从长形体在瓣的第二侧展开，使得第一针在第一位置穿透瓣并接合第一缝合线部分，使得第二针在第二位置穿透瓣并接合第二缝合线部分。可以将第一和第二缝合线部分从第一侧至第二侧拉过瓣。可以将第一和第二缝合线部分牢固地保持在一起。In some embodiments, the anatomical flap can be sutured by the following steps: the elongated body is at least partially placed in the anatomical flap, and the arms are extended from the elongated body on a first side of the flap, and the first arms releasably hold the first and second suture portions. The free ends of the arms can be located at or adjacent to the base of the flap. The first and second needles can be extended from the elongated body on a second side of the flap, so that the first needle penetrates the flap and engages the first suture portion at a first position, and the second needle penetrates the flap and engages the second suture portion at a second position. The first and second suture portions can be pulled through the flap from the first side to the second side. The first and second suture portions can be securely held together.
在一些实施方案中，可以通过以下步骤缝合解剖学瓣：将长形体至少部分地置于解剖学瓣中，并使至少两个臂从长形体展开，每个臂可释放地保持缝合线部分。可以使每个臂的自由端位于或邻近瓣的基部。可以使针从长形体展开，使得每个针穿透瓣和接合对应的缝合线部分。可以将缝合线部分拉过瓣叶。可以将缝合线部分以不少于两个为一组牢固地保持在一起。In some embodiments, an anatomical flap can be sutured by placing an elongated body at least partially within the anatomical flap and deploying at least two arms from the elongated body, each arm releasably holding a suture portion. The free end of each arm can be positioned at or adjacent the base of the flap. Needles can be deployed from the elongated body such that each needle penetrates the flap and engages a corresponding suture portion. The suture portions can be pulled through the leaflets. The suture portions can be securely held together in groups of no less than two.
在一些实施方案中，可以通过以下步骤缝合解剖学瓣：使包括长形体的缝合装置通过瓣，以及使多个臂从所述缝合装置的长形体伸出，每个臂携带缝合线的端部。可以使至少一对臂位于或邻近瓣的基部。可以使保护构件从长形体向位于或邻近瓣的基部的第一个臂伸出。可以使针前进通过保护构件，在第一位置通过瓣的组织，并与由第一臂携带的第一个缝合线端部接触。可以将针通过瓣的组织收回，从而将第一缝合线端部拉过组织。可以沿着长形体转动保护构件，使得保护构件向位于或邻近瓣的基部的第二个臂伸出。可以使针前进通过保护构件，在第二位置通过瓣的组织，并与由第二臂携带的第二个缝合线端部接触。可以将所述针通过瓣的组织收回，从而将第二缝合线端部拉过组织。可以利用通过所述位置的缝合线拉近第一和第二位置之间的距离。In some embodiments, an anatomical flap can be sutured by passing a suturing device comprising an elongated body through the flap, and extending a plurality of arms from the elongated body of the suturing device, each arm carrying an end of a suture. At least one pair of arms can be located at or adjacent to the base of the flap. A protective member can be extended from the elongated body toward a first arm located at or adjacent to the base of the flap. A needle can be advanced through the protective member, passing through the tissue of the flap at a first position, and contacting the end of a first suture carried by the first arm. The needle can be retracted through the tissue of the flap, thereby pulling the end of the first suture through the tissue. The protective member can be rotated along the elongated body so that the protective member extends toward a second arm located at or adjacent to the base of the flap. A needle can be advanced through the protective member, passing through the tissue of the flap at a second position, and contacting the end of a second suture carried by the second arm. The needle can be retracted through the tissue of the flap, thereby pulling the end of the second suture through the tissue. The suture passing through the said position can be used to close the distance between the first and second positions.
在一些实施方案中，可以通过以下步骤缝合二尖瓣：经心尖将缝合装置递送通过心脏并进入左心室。缝合装置可以具有近端、远端，在近端和远端之间延伸的长形体以及位于近端的手柄。可以至少将装置的远端递送通过二尖瓣。可以使第一臂和第二臂从长形体、从第一位置伸出至第二位置，在第一位置时，第一臂和第二臂被收入长形体，在第二位置时，第一臂和第二臂具有从长形体伸出并远离长形体的自由端。第一臂可以携带第一缝合线端部，第二臂可以携带第二缝合线端部。可以将第一臂和第二臂置于瓣的心房侧的位于或邻近瓣的基部的位置。In some embodiments, the mitral valve can be sutured by the following steps: delivering a suturing device through the heart and into the left ventricle through the apex of the heart. The suturing device can have a proximal end, a distal end, an elongated body extending between the proximal end and the distal end, and a handle at the proximal end. At least the distal end of the device can be delivered through the mitral valve. A first arm and a second arm can be extended from the elongated body, from a first position to a second position, wherein in the first position, the first arm and the second arm are retracted into the elongated body, and in the second position, the first arm and the second arm have free ends extending from the elongated body and away from the elongated body. The first arm can carry a first suture end and the second arm can carry a second suture end. The first arm and the second arm can be placed at a position at or adjacent to the base of the valve on the atrial side of the valve.
可以使针臂从缩回位置伸出至初始伸出位置，在缩回位置时，针臂被收入长形体，在初始伸出位置时，针臂位于臂的近侧。位于初始伸出位置的针臂可以在瓣的心室侧、在邻近腱索之间、从长形体沿远侧方向向外伸出远离长形体。可以朝向第一臂转动针臂，同时针臂保持在瓣的心室侧上，使得针臂朝向位于或邻近瓣的基部的第一臂伸出。The needle arm can be extended from a retracted position, in which the needle arm is retracted into the elongated body, to an initial extended position, in which the needle arm is located proximal to the arm. The needle arm in the initial extended position can extend outwardly from the elongated body in a distal direction away from the elongated body on the ventricular side of the valve between adjacent chordae tendineae. The needle arm can be rotated toward the first arm while the needle arm remains on the ventricular side of the valve so that the needle arm extends toward the first arm at or adjacent to the base of the valve.
可以使第一针向远侧前进，离开所述针臂，在第一位置通过瓣的组织，并与第一缝合线端部接触。可以将第一针通过瓣的组织收回，从而将第一缝合线端部拉过组织，并且第一段缝合线能从第一缝合线端部前进并通过组织。可以朝向第二臂转动针臂，同时针臂保持在瓣的心室侧上，使得针臂朝向位于或邻近瓣的基部的第二臂伸出。可以使第二针向远侧前进，离开针臂，在第二位置通过瓣的组织，并与第二缝合线端部接触。可以将第二针通过瓣的组织收回，从而将第二缝合线端部拉过组织，并且第二段缝合线从第二缝合线端部前进并通过组织。The first needle can be advanced distally, away from the needle arm, through the tissue of the valve at a first position, and contacting the end of the first suture. The first needle can be retracted through the tissue of the valve, thereby pulling the end of the first suture through the tissue, and the first section of suture can be advanced from the first suture end and through the tissue. The needle arm can be rotated toward the second arm while the needle arm remains on the ventricular side of the valve, so that the needle arm extends toward the second arm located at or adjacent to the base of the valve. The second needle can be advanced distally, away from the needle arm, through the tissue of the valve at a second position, and contacting the end of the second suture. The second needle can be retracted through the tissue of the valve, thereby pulling the end of the second suture through the tissue, and the second section of suture can be advanced from the second suture end and through the tissue.
可以转动针臂回到初始伸出位置。可以使针臂向近侧运动回到缩回位置。可以使第一和第二臂从第二位置移回第一位置。可以从二尖瓣撤出缝合装置，并且第一段和第二段缝合线可以保持在组织内。可以将第一和第二位置之间的第一距离拉近至第一和第二位置之间的第二距离。The needle arm can be rotated back to the initial extended position. The needle arm can be moved proximally back to the retracted position. The first and second arms can be moved from the second position back to the first position. The suturing device can be withdrawn from the mitral valve, and the first and second suture segments can remain within the tissue. The first distance between the first and second positions can be shortened to a second distance between the first and second positions.
在一些实施方案中，可以通过以下步骤缝合组织：将缝合装置递送至邻近组织的位置。缝合装置可以具有近端、远端、在近端和远端之间延伸的长形体以及位于近端的手柄。可以至少将装置的远端递送至邻近组织的位置。可以使第一臂和第二臂从长形体、从第一位置伸出至第二位置，在第一位置时，第一臂和第二臂被收入长形体，在第二位置时，第一臂和第二臂具有从长形体伸出并远离长形体的自由端，并且第一臂和第二臂彼此形成角。第一臂可以携带第一缝合线端部，第二臂可以携带第二缝合线端部。可以使第一和第二臂邻近组织的第一侧。In some embodiments, tissue can be sutured by the following steps: delivering a suturing device to a position adjacent to tissue. The suturing device can have a proximal end, a distal end, an elongated body extending between the proximal end and the distal end, and a handle at the proximal end. At least the distal end of the device can be delivered to a position adjacent to tissue. The first arm and the second arm can be extended from the elongated body, from a first position to a second position, when the first position, the first arm and the second arm are received in the elongated body, when the second position, the first arm and the second arm have free ends extending from the elongated body and away from the elongated body, and the first arm and the second arm form an angle with each other. The first arm can carry the first suture end, and the second arm can carry the second suture end. The first and second arms can be made adjacent to the first side of tissue.
可以使针臂从缩回位置运动至伸出位置，在缩回位置时，针臂被收入长形体，在伸出位置时，针臂朝向第一臂伸出。针臂可以与第一臂和第二臂位于组织的两侧。可以使第一针前进，离开针臂，在第一位置通过组织，并与第一缝合线端部接触。可以将第一针通过组织收回，从而将第一缝合线端部拉过组织，并且第一段缝合线可以从第一缝合线端部前进并通过组织。可以朝向第二臂转动针臂，使得针臂朝向第二臂伸出。可以使第二针前进，离开针臂，在第二位置通过所述组织，并与第二缝合线端部接触。可以将第二针通过组织收回，从而将第二缝合线端部拉过组织，并且第二段缝合线可以从第二缝合线端部前进并通过组织。The needle arm can be moved from a retracted position to an extended position, wherein the needle arm is retracted into the elongated body in the retracted position and the needle arm is extended toward the first arm in the extended position. The needle arm can be located on either side of the tissue with the first arm and the second arm. The first needle can be advanced, exit the needle arm, pass through the tissue at a first position, and contact the end of the first suture. The first needle can be retracted through the tissue so that the end of the first suture is pulled through the tissue, and the first section of suture can be advanced from the first suture end and through the tissue. The needle arm can be rotated toward the second arm so that the needle arm is extended toward the second arm. The second needle can be advanced, exit the needle arm, pass through the tissue at a second position, and contact the end of the second suture. The second needle can be retracted through the tissue so that the end of the second suture is pulled through the tissue, and the second section of suture can be advanced from the second suture end and through the tissue.
可以使针臂运动回到缩回位置。可以使第一和第二臂从第二位置移回第一位置。可以从组织部位撤出缝合装置，并且第一段和第二段缝合线可以保持在组织内。The needle arm can be moved back to the retracted position. The first and second arms can be moved from the second position back to the first position. The suturing device can be withdrawn from the tissue site, and the first and second suture sections can remain within the tissue.
在一些实施方案中，可以通过以下步骤缝合解剖学瓣：将长形体至少部分地置于解剖学瓣中。可以使第一臂从长形体展开，并且第一臂可以将第一缝合线部分可释放地保持在自由端。可以使第一臂的自由端位于或邻近第一瓣叶的边缘、位于瓣的第一侧上。可以使第一针臂从长形体、在瓣的另一侧展开，使得第一瓣叶位于针臂和第一臂之间。可以使第一针从展开的第一针臂展开，使得第一针在第一位置穿透第一瓣叶并接合第一缝合线部分。可以将第一缝合线部分拉过第一瓣叶。可以使第二缝合线部分在第二位置通过第二瓣叶，以及可以利用通过第一和第二位置的缝合线，将两个瓣叶拉近在一起。In some embodiments, the anatomical flap can be sutured by the following steps: an elongated body is at least partially placed in the anatomical flap. A first arm can be extended from the elongated body, and the first arm can releasably retain the first suture portion at the free end. The free end of the first arm can be located at or adjacent to the edge of the first leaflet, on a first side of the flap. A first needle arm can be extended from the elongated body, on the other side of the flap, so that the first leaflet is located between the needle arm and the first arm. A first needle can be extended from the extended first needle arm, so that the first needle penetrates the first leaflet at a first position and engages the first suture portion. The first suture portion can be pulled through the first leaflet. A second suture portion can be passed through the second leaflet at a second position, and the two leaflets can be drawn together using the sutures passed through the first and second positions.
以上公开内容描述了本申请的某些实施方案的实例。设计、特征以及描述是本申请的某些实施方案的非限制性实例。装置和方法的其他实施方案可以包括或不包括本文公开的特征。此外，所公开的优势和益处可以仅适用于本申请的某些实施方案，并不应当用来限制发明。The above disclosure describes examples of certain embodiments of the present application. The designs, features, and descriptions are non-limiting examples of certain embodiments of the present application. Other embodiments of the apparatus and method may include or not include the features disclosed herein. In addition, the disclosed advantages and benefits may only apply to certain embodiments of the present application and should not be used to limit the invention.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
以下参考具体实施方案的附图描述本文公开的上述特征和其他特征。所说明的实施方案意图用于举例说明，而并非限制。附图具有以下特征：The above and other features disclosed herein are described below with reference to the accompanying drawings of specific embodiments. The illustrated embodiments are intended to be illustrative rather than limiting. The drawings have the following features:
图1显示了提供进入示例性使用环境(例如心脏的主动脉瓣)的途径的方法。FIG1 illustrates a method of providing access to an exemplary environment of use, such as the aortic valve of a heart.
图2A显示了提供进入示例性使用环境(例如心脏的二尖瓣)的途径的方法。FIG. 2A illustrates a method of providing access to an exemplary environment of use, such as the mitral valve of a heart.
图2B显示了提供进入示例性使用环境(例如心脏的二尖瓣)的途径的方法。FIG2B illustrates a method of providing access to an exemplary environment of use, such as the mitral valve of a heart.
图3是具有缝合线扣臂和外壳的缝合装置的实施方案的立体图，缝合线扣臂位于缩回位置，外壳显示为截面。3 is a perspective view of an embodiment of a suturing device having a suture clip arm and a housing, with the suture clip arm in a retracted position and the housing shown in cross-section.
图4是图3的实施方案的放大立体图，外壳显示为截面，该图显示了处于部分前进位置的缝合线捕捉机构。4 is an enlarged perspective view of the embodiment of FIG. 3 with the housing shown in section, showing the suture capturing mechanism in a partially advanced position.
图5是图3的实施方案的立体图，其中缝合线扣臂处于伸出位置，缝合线捕捉机构处于部分前进位置。5 is a perspective view of the embodiment of FIG. 3 with the suture clip arm in an extended position and the suture capture mechanism in a partially advanced position.
图6是图3的实施方案的立体图，如图5，该图显示了附接于装置的外壳。6 is a perspective view of the embodiment of FIG. 3, as in FIG. 5, showing the housing attached to the device.
图7A是图3的实施方案的平面图，其中缝合线扣臂处于伸出位置。Figure 7A is a plan view of the embodiment of Figure 3, wherein the suture clip arm is in an extended position.
图7B是图7A所示的平面图，其中缝合线扣臂被收回。Figure 7B is a plan view of Figure 7A with the suture clip arms retracted.
图8是沿图6中的线VIII-VIII获得的图3的实施方案的截面图。FIG. 8 is a cross-sectional view of the embodiment of FIG. 3 taken along line VIII-VIII in FIG. 6 .
图9是沿图7A中的线IX-IX获得的图3的实施方案的截面图。FIG. 9 is a cross-sectional view of the embodiment of FIG. 3 taken along line IX-IX in FIG. 7A .
图10是缝合装置的一个实施方案的示意图，该缝合装置位于通过瓣的通道内。10 is a schematic diagram of one embodiment of a suturing device positioned within a passage through a valve.
图11是图10的示意图，其中缝合线扣臂位于瓣的第一和第二瓣叶的周围。Figure 11 is a schematic diagram of Figure 10, in which the suture clip arms are located around the first and second leaflets of the valve.
图12是图11的示意图，其中缝合线扣臂被收回。Figure 12 is a schematic diagram of Figure 11, in which the suture clip arm is retracted.
图13是图12的示意图，该图显示了缝合线捕捉机构接合缝合线扣臂。Figure 13 is a schematic diagram of Figure 12, showing the suture capture mechanism engaging the suture buckle arm.
图14是图13的示意图，该图显示了缝合线捕捉机构和缝合线部分通过第一和第二瓣叶被收回。14 is a schematic diagram of FIG. 13 showing the suture capture mechanism and the suture portion being retrieved through the first and second leaflets.
图15是图14的示意图，该图显示了缝合线部分延伸通过第一和第二瓣叶并被结连接在一起。15 is a schematic diagram of FIG. 14 showing the suture portion extending through the first and second leaflets and connected together by a knot.
图16是缝合装置系统的一个实施方案的平面图，该缝合装置系统具有两个缝合装置和缝合线连接装置。16 is a plan view of one embodiment of a suturing device system having two suturing devices and a suture connecting device.
图17是缝合装置的一个实施方案的平面图，其中缝合线扣臂处于伸出位置。Figure 17 is a plan view of one embodiment of the suturing device with the suture clip arms in an extended position.
图18是图17的缝合装置的远端的放大立体图，其中缝合线扣臂处于伸出位置。18 is an enlarged perspective view of the distal end of the suturing device of FIG. 17 , with the suture clip arms in an extended position.
图19是第一缝合装置的一个实施方案的示意图，第一缝合装置位于通过瓣的通道内。Figure 19 is a schematic diagram of one embodiment of a first suturing device positioned within a passage through a valve.
图20是图19的示意图，其中缝合线扣臂位于瓣的第一瓣叶的周围。Figure 20 is a schematic diagram of Figure 19, in which the suture clip arm is located around the first leaflet of the valve.
图21是图20的示意图，该图显示了缝合线捕捉机构接合缝合线扣臂。Figure 21 is a schematic diagram of Figure 20, showing the suture capture mechanism engaging the suture buckle arm.
图22是图21的示意图，该图显示了缝合线捕捉机构和缝合线部分通过第一瓣叶被收回。22 is a schematic diagram of FIG. 21 showing the suture capture mechanism and the suture portion being retrieved through the first leaflet.
图23是图22的示意图，该图显示了第二缝合装置位于通过瓣的通道内。Figure 23 is a schematic diagram of Figure 22 showing the second suturing device positioned within the passage through the valve.
图24是图23的示意图，其中缝合线扣臂位于瓣的第二瓣叶的周围。Figure 24 is a schematic diagram of Figure 23, in which the suture clip arm is located around the second leaflet of the valve.
图25是图24的示意图，该图显示了缝合线捕捉机构接合缝合线扣臂。Figure 25 is a schematic diagram of Figure 24, showing the suture capture mechanism engaging the suture buckle arm.
图26是图25的示意图，该图显示了缝合线捕捉机构和缝合线部分通过第二瓣叶被收回。26 is a schematic diagram of FIG. 25 showing the suture capture mechanism and the suture portion being retrieved through the second leaflet.
图27是图26的示意图，该图显示了缝合线部分延伸通过第一瓣叶和第二瓣叶并被第一结连接在一起。27 is a schematic diagram of FIG. 26 showing a suture portion extending through the first leaflet and the second leaflet and connected together by a first knot.
图28是缝合装置的一个实施方案的平面图，其中缝合线扣臂处于伸出位置。Figure 28 is a plan view of one embodiment of a suturing device with the suture clip arm in an extended position.
图29是图28的缝合装置的远端的放大立体图，其中缝合线扣臂处于伸出位置。Figure 29 is an enlarged stereoscopic view of the distal end of the suturing device of Figure 28, wherein the suture clip arm is in an extended position.
图30是第一缝合装置的一个实施方案的示意图，第一缝合装置位于通过瓣的通道内。Figure 30 is a schematic diagram of one embodiment of a first suturing device positioned within a passage through a valve.
图31是图30的示意图，其中缝合线扣臂位于瓣的第一瓣叶的周围。Figure 31 is a schematic diagram of Figure 30, in which the suture clip arm is located around the first leaflet of the valve.
图32是图31的示意图，该图显示了缝合线捕捉机构接合缝合线扣臂。Figure 32 is a schematic diagram of Figure 31, showing the suture capture mechanism engaging the suture buckle arm.
图33是图32的示意图，该图显示了缝合线捕捉机构和缝合线部分通过第一瓣叶被收回。33 is a schematic diagram of FIG. 32 showing the suture capture mechanism and the suture portion being retrieved through the first leaflet.
图34是图33的示意图，该图显示了第二缝合装置位于通过瓣的通道内，从而允许缝合线扣臂从第二缝合装置伸出。Figure 34 is a schematic diagram of Figure 33, showing the second suturing device positioned within a channel through the flap, thereby allowing the suture clip arm to extend from the second suturing device.
图35是图34的示意图，其中缝合线扣臂位于瓣的第二瓣叶的周围。Figure 35 is a schematic diagram of Figure 34, in which the suture clip arm is located around the second leaflet of the valve.
图36是图35的示意图，该图显示了缝合线捕捉机构接合缝合线扣臂。Figure 36 is a schematic diagram of Figure 35, showing the suture capture mechanism engaging the suture buckle arm.
图37是图36的示意图，该图显示了缝合线捕捉机构和缝合线部分通过第二瓣叶被收回。37 is a schematic diagram of FIG. 36 showing the suture capture mechanism and the suture portion being retrieved through the second leaflet.
图38A是缝合装置的一个实施方案的平面图，其中两个缝合线扣臂处于伸出位置。Figure 38A is a plan view of one embodiment of a suturing device with two suture clip arms in an extended position.
图38B是图38A的缝合装置的远端的放大立体图，其中缝合线扣臂处于伸出位置。Figure 38B is an enlarged perspective view of the distal end of the suturing device of Figure 38A, wherein the suture clip arm is in an extended position.
图39A是缝合装置的一个实施方案的远端的放大立体图，其中两个缝合线扣臂处于缩回位置。Figure 39A is an enlarged perspective view of the distal end of one embodiment of the suturing device, wherein the two suture clip arms are in a retracted position.
图39B是图39A的缝合装置的远端的放大立体图，其中缝合线扣臂处于伸出位置。Figure 39B is an enlarged perspective view of the distal end of the suturing device of Figure 39A, wherein the suture clip arm is in an extended position.
图40是缝合装置的一个实施方案的示意图，缝合装置位于通过瓣的通道内。Figure 40 is a schematic diagram of one embodiment of a suturing device positioned within a passage through a valve.
图41是图40的示意图，其中缝合线扣臂位于瓣的第一瓣叶的周围。Figure 41 is a schematic diagram of Figure 40, in which the suture clip arm is located around the first leaflet of the valve.
图42是图41的示意图，该图显示了缝合线捕捉机构接合缝合线扣臂。Figure 42 is a schematic diagram of Figure 41, showing the suture capture mechanism engaging the suture buckle arm.
图43是图42的示意图，该图显示了缝合线捕捉机构和缝合线部分通过第一瓣叶被收回。43 is a schematic diagram of FIG. 42 showing the suture capture mechanism and the suture portion being retracted through the first leaflet.
图44是图43的示意图，该图显示了缝合装置位于通过瓣的通道内，从而允许第二缝合线扣臂从缝合装置伸出。Figure 44 is a schematic diagram of Figure 43, showing the suturing device positioned within a channel through the valve, thereby allowing the second suture clip arm to extend from the suturing device.
图45是图44的示意图，其中缝合线扣臂位于瓣的第二瓣叶的周围。Figure 45 is a schematic diagram of Figure 44, in which the suture clip arm is located around the second leaflet of the valve.
图46是图45的示意图，该图显示了缝合线捕捉机构接合缝合线扣臂。Figure 46 is a schematic diagram of Figure 45, showing the suture capture mechanism engaging the suture buckle arm.
图47是图46的示意图，该图显示了缝合线捕捉机构和缝合线部分通过第二瓣叶被收回。47 is a schematic diagram of FIG. 46 showing the suture capture mechanism and the suture portion being retrieved through the second leaflet.
图48是缝合装置的一个实施方案的示意图，缝合装置位于通过瓣的通道内，其中第一缝合线扣臂位于瓣的第一瓣叶的周围，第二缝合线扣臂位于瓣的第二瓣叶的周围。Figure 48 is a schematic diagram of an embodiment of a suturing device, wherein the suturing device is positioned within a passage through a valve, wherein a first suture clip arm is positioned around a first leaflet of the valve and a second suture clip arm is positioned around a second leaflet of the valve.
图49是图47或48的示意图，该图显示了缝合线部分延伸通过第一瓣叶和第二瓣叶。49 is a schematic diagram of FIG. 47 or 48 showing a suture partially extending through the first leaflet and the second leaflet.
图50是图49的示意图，该图显示了缝合线部分延伸通过第一瓣叶和第二瓣叶，并通过第一结连接在一起。50 is a schematic diagram of FIG. 49 showing a suture portion extending through the first leaflet and the second leaflet and connected together by a first knot.
图51是图50的示意图，该图显示了缝合线部分延伸通过第一瓣叶和第二瓣叶，并通过第一结连接在一起，第一结被拉在瓣叶之间。51 is a schematic diagram of FIG. 50 showing a suture portion extending through the first leaflet and the second leaflet and connected together by a first knot, the first knot being drawn between the leaflets.
图52是图51的示意图，该图显示了缝合线部分延伸通过第一瓣叶和第二瓣叶，并通过第一结连接在一起，第一结被拉过其中一个瓣叶。52 is a schematic diagram of FIG. 51 showing a suture portion extending through the first leaflet and the second leaflet and connected together by a first knot pulled through one of the leaflets.
图53是图49的示意图，该图显示了缝合线部分延伸通过第一瓣叶和第二瓣叶，并通过第一结连接在一起。53 is a schematic diagram of FIG. 49 showing a suture portion extending through the first leaflet and the second leaflet and connected together by a first knot.
图54显示了缝合线通过二尖瓣，位于每个瓣叶的中央部分的附近。Figure 54 shows the sutures passed through the mitral valve near the central portion of each leaflet.
图55显示了三个缝合线通过二尖瓣，位于每个瓣叶的中央部分的附近。Figure 55 shows three sutures passed through the mitral valve near the central portion of each leaflet.
图56显示了缝合线通过二尖瓣，位于远离每个瓣叶的中央的位置。Figure 56 shows the sutures passed through the mitral valve at a location away from the center of each leaflet.
图57显示了缝合线通过二尖瓣，位于远离每个瓣叶的中央的多个位置。Figure 57 shows sutures passed through the mitral valve at various locations away from the center of each leaflet.
图58显示了缝合线通过三尖瓣。Figure 58 shows the passage of sutures through the tricuspid valve.
图59显示了缝合线通过三尖瓣。Figure 59 shows the passage of sutures through the tricuspid valve.
图60显示了缝合线通过三尖瓣。Figure 60 shows the passage of sutures through the tricuspid valve.
图61显示了缝合通过腱索和心肌。Figure 61 shows the suture passed through the chordae tendineae and myocardium.
图62是缝合装置的一个实施方案的示意性立体图，缝合装置包括两个针和具有两个缝合线座架的单个臂。Figure 62 is a schematic perspective view of one embodiment of a suturing device comprising two needles and a single arm with two suture holders.
图63是图62的缝合装置的示意性侧视图，其中臂是伸出的，并且保护构件是伸出的。63 is a schematic side view of the suturing device of FIG. 62 with the arms extended and the protective member extended.
图64是图62和63的缝合装置的示意性侧视图，其中针通过保护构件伸出。64 is a schematic side elevational view of the suturing device of FIGS. 62 and 63 with the needle extending through the protective member.
图65是图62-64的缝合装置的示意图，缝合装置位于通过瓣的通道内，例如经心尖开口通过二尖瓣。65 is a schematic illustration of the suturing device of FIGS. 62-64 positioned within a passage through a valve, such as through the mitral valve through the transapical opening.
图66是图65的示意图，其中臂是伸出的，并且保护构件是伸出的。Figure 66 is a schematic diagram of Figure 65, in which the arm is extended and the protective member is extended.
图67是图66的示意图，其中针伸出，从而穿透瓣并接合臂。Figure 67 is a schematic diagram of Figure 66, in which the needle is extended, thereby penetrating the flap and engaging the arm.
图68是沿线68-68获取的图67的臂、针和瓣的示意性部分截面图。Figure 68 is a schematic partial cross-sectional view of the arm, needle and flap of Figure 67 taken along line 68-68.
图69是图68的示意性部分截面图，该图显示了缝合线部分通过瓣中的两个位置。Figure 69 is a schematic partial cross-sectional view of Figure 68 showing the passage of suture portions through two locations in the flap.
图70是图69的示意性部分截面图，其中缝合线部分被牢固地保持在一起。70 is a schematic partial cross-sectional view of FIG. 69 , with the suture portions securely held together.
图71是与图68相似的臂、针以及瓣的示意性部分截面图，区别在于所示的臂包括单个缝合线座架和单个针。Figure 71 is a schematic partial cross-sectional view of an arm, needle, and flap similar to Figure 68, except that the arm is shown to include a single suture holder and a single needle.
图72是图71的示意性部分截面图，其中第一缝合线部分通过瓣，并且所示的第二臂和第二针正处于使第二缝合线部分通过瓣中的第二位置的过程中。72 is a schematic partial cross-sectional view of FIG. 71 with the first suture portion passed through the flap and the second arm and second needle shown in the process of passing the second suture portion through a second position in the flap.
图73是图72的示意图，其中两个缝合线部分通过瓣，并且缝合线部分的第一端被牢固地保持在一起。Figure 73 is a schematic diagram of Figure 72, in which the two suture portions are passed through the flap and the first ends of the suture portions are securely held together.
图74是图73的示意图，其中第二缝合线端部被拉动，从而将牢固保持的第一端拉向瓣的第一侧。Figure 74 is a schematic diagram of Figure 73, in which the second suture end is pulled, thereby pulling the firmly retained first end toward the first side of the flap.
图75是图74的示意图，其中第二缝合线端部牢固地保持在一起。75 is a schematic illustration of FIG. 74 with the second suture ends securely held together.
图76是缝合装置的一个实施方案的示意性立体图，缝合装置包括两个针和具有两个缝合线座架的单个臂，两个针位于臂的远侧并被设置为能向近侧运动而接合臂。Figure 76 is a schematic stereoscopic illustration of one embodiment of a suturing device comprising two needles and a single arm having two suture holders, wherein the two needles are located distally of the arm and are configured to move proximally to engage the arm.
图77是图76的缝合装置的示意图，其位于瓣的通道内，例如通过下腔静脉和房间隔进入二尖瓣。Figure 77 is a schematic diagram of the suturing device of Figure 76, which is positioned within a passage of the valve, such as entering the mitral valve through the inferior vena cava and the atrial septum.
图78是图77的示意图，其中臂是伸出的，并且保护构件是伸出的。Figure 78 is a schematic diagram of Figure 77, wherein the arm is extended and the protective member is extended.
图79是图78的示意图，其中针前进通过保护构件而接合臂。79 is a schematic illustration of FIG. 78 with the needle advanced through the guard member to engage the arms.
图80是缝合装置的示意性立体图，缝合装置包括两个针和具有两个缝合线座架的单个臂，两个针位于臂的仅侧并被设置为能向远侧运动而接合臂，并且臂具有伸出位置，在伸出位置时，臂的方向相对于缝合装置的纵轴成少于90°的角。Figure 80 is a schematic stereoscopic view of a suturing device comprising two needles and a single arm having two suture holders, the two needles being located on either side of the arm and being configured to move distally to engage the arm, and the arm having an extended position in which the arm is oriented at an angle of less than 90° relative to the longitudinal axis of the suturing device.
图81是图80的缝合装置的示意图，其位于瓣的通道内，例如例如通过下腔静脉和房间隔进入二尖瓣，其中臂是伸出的。Figure 81 is a schematic diagram of the suturing device of Figure 80, positioned within a passage through the valve, such as through the inferior vena cava and the atrial septum into the mitral valve, with the arms extended.
图82是图81的示意图，其中保护构件是伸出的。Figure 82 is a schematic diagram of Figure 81, in which the protective member is extended.
图83是图82的示意图，其中针前进通过保护构件而接合臂。83 is a schematic illustration of FIG. 82 with the needle advanced through the guard member to engage the arms.
图84是按照一个实施方案的缝合线放置位置的示意图。84 is a schematic diagram of suture placement locations according to one embodiment.
图85是按照一个实施方案的缝合线放置位置的示意图。85 is a schematic diagram of suture placement locations according to one embodiment.
图86是显示了腱索的人类心脏的示意图。Figure 86 is a schematic diagram of a human heart showing the chordae tendineae.
图87是缝合装置的一个实施方案的示意性立体图。Figure 87 is a schematic perspective view of one embodiment of a suturing device.
图88是图87的缝合装置的示意图，其中6个臂是伸出的，每个臂具有两个缝合线座架，并且保护构件是伸出的。Figure 88 is a schematic diagram of the suturing device of Figure 87, wherein the six arms are extended, each arm has two suture holders, and the protective member is extended.
图89是图87和88的缝合装置的示意图，其位于通过瓣的通道内，例如经心尖开口进入二尖瓣。Figure 89 is a schematic illustration of the suturing device of Figures 87 and 88 positioned within a passage through the valve, such as through the apical opening into the mitral valve.
图90是图89的示意图，其中臂是伸出的。Figure 90 is a schematic diagram of Figure 89, in which the arms are extended.
图91是图90的示意图，其中保护构件是伸出的。Figure 91 is a schematic diagram of Figure 90, in which the protective member is extended.
图92是图91的示意图，其中保护构件的位置用于使针运动通过保护构件而接合第一臂。92 is a schematic diagram of FIG. 91 with the guard member positioned to allow the needle to move through the guard member to engage the first arm.
图93是图92的示意图，其中保护构件的位置用于使针运动通过保护构件而接合第二臂。93 is a schematic diagram of FIG. 92 with the guard member positioned to allow the needle to move through the guard member to engage the second arm.
图94是图93的示意图，其中缝合线部分通过瓣中的12个位置。Figure 94 is a schematic diagram of Figure 93, in which the suture is partially passed through 12 locations in the flap.
图95是缝合装置的一个实施方案的平面图。Figure 95 is a plan view of one embodiment of a suturing device.
图96是缝合装置的一个实施方案的示意性立体图。Figure 96 is a schematic perspective view of one embodiment of a suturing device.
图97是缝合装置的一个实施方案的示意性立体图，其中针臂和两个缝合臂处于伸出位置。Figure 97 is a schematic perspective view of one embodiment of a suturing device with the needle arm and two suturing arms in an extended position.
图98是缝合臂的一个实施方案的截面图。Figure 98 is a cross-sectional view of one embodiment of a suturing arm.
图99是图95的装置的一部分的截面图，该图显示了针臂是伸出的并且对准伸出的缝合臂。Figure 99 is a cross-sectional view of a portion of the device of Figure 95 showing the needle arm extended and aligned with the extended suturing arm.
图100是图95的装置的顶视图，其中缝合臂是伸出的。Figure 100 is a top view of the device of Figure 95, wherein the suturing arms are extended.
图101是针臂的一个实施方案的远侧部分的截面图。Figure 101 is a cross-sectional view of the distal portion of one embodiment of a needle arm.
图102是突出部的一个实施方案的顶视图。Figure 102 is a top view of one embodiment of a protrusion.
图103是图95的缝合装置的示意图，其位于通过瓣的通道内，例如经心尖开口进入二尖瓣。Figure 103 is a schematic diagram of the suturing device of Figure 95, which is positioned within a passage through the valve, such as entering the mitral valve through the apical opening.
图104是图103的示意图，其中臂是伸出的。Figure 104 is a schematic diagram of Figure 103, in which the arms are extended.
图105是图104的示意图，其中臂抵靠瓣。Figure 105 is a schematic diagram of Figure 104, in which the arm rests against the petal.
图106是图105的示意图，其中保护构件是伸出的。Figure 106 is a schematic diagram of Figure 105, in which the protective member is extended.
图107是图106的示意图，其中保护构件的位置用于使针运动通过保护构件而接合第一臂。107 is a schematic diagram of FIG. 106 with the guard member positioned to allow the needle to move through the guard member to engage the first arm.
图108是图107的示意图，其中针接合第一臂。Figure 108 is a schematic diagram of Figure 107, in which the needle engages the first arm.
图109是图108的示意图，其中针臂位于两个缝合臂之间。Figure 109 is a schematic diagram of Figure 108, in which the needle arm is located between the two suturing arms.
图110是图109的示意图，其中保护构件的位置用于使针运动通过保护构件而接合第二臂。110 is a schematic diagram of FIG. 109 with the guard member positioned to allow the needle to move through the guard member to engage the second arm.
图111是图110的示意图，其中针接合第二臂。Figure 111 is a schematic diagram of Figure 110, in which the needle engages the second arm.
图112是图111的示意图，其中针臂位于两个缝合臂之间。Figure 112 is a schematic diagram of Figure 111, in which the needle arm is located between the two suturing arms.
图113是图112的示意图，其中缝合线部分通过瓣中的两个位置。Figure 113 is a schematic diagram of Figure 112, in which the suture portion passes through two locations in the flap.
图114是图112的示意图，该图显示了缝合线部分通过瓣中的两个位置并通过第一结连接在一起。Figure 114 is a schematic diagram of Figure 112 showing the suture portions passed through two locations in the flap and connected together by a first knot.
图115是瓣的截面侧视图的示意图，该图显示了位于通过瓣的缝合线周围的管。Figure 115 is a schematic diagram of a cross-sectional side view of a flap showing the tube positioned around the sutures passing through the flap.
图116是图115的示意图，该图显示了两个缝合线端部已被拉紧并牢固地保持在一起。116 is a schematic diagram of FIG. 115 showing the two suture ends having been tightened and securely held together.
图117是结放置装置的侧视图。117 is a side view of the knot placement device.
图118是结和结放置装置的截面图。Figure 118 is a cross-sectional view of a knot and knot placement device.
图119是结和结放置装置的一个实施方案的截面图。119 is a cross-sectional view of one embodiment of a knot and a knot placement device.
具体实施方式DETAILED DESCRIPTION
本文公开了用于缝合生物组织的缝合装置和方法的实施方案。缝合装置及其使用方法可以用于多种操作，例如处理(例如，闭合)伤口和自然生成的或手术制造的孔或通道。例如，缝合装置可以用于处理解剖学瓣，例如心脏瓣膜，包括被减弱或拉伸或具有使心脏瓣膜不能正确闭合的其他结构缺陷(例如先天缺陷)的心脏瓣膜。在一些实施方案中，可以使用一个或多个缝合装置来处理或修复瓣，例如三尖瓣、肺动脉瓣、二尖瓣以及主动脉瓣。在一些实施方案中，一个或多个缝合装置可以用于实施多种操作，例如缘至缘修复(类似于Alfieri技术)、瓣膜成形术(利用或不利用环或其他植入物)、心室空间缝合、腱索缝合、心脏中其他位置的缝合、腱索置换、腱索缩短、施加补丁、瓣叶再成形以及修补物附接，例如环和生物学或机械置换瓣。Disclosed herein are embodiments of suturing devices and methods for suturing biological tissue. Suturing devices and methods of use thereof can be used for a variety of operations, such as treating (e.g., closing) wounds and naturally occurring or surgically created holes or channels. For example, suturing devices can be used to treat anatomical valves, such as heart valves, including heart valves that are weakened or stretched or have other structural defects (e.g., congenital defects) that prevent the heart valve from closing properly. In some embodiments, one or more suturing devices can be used to treat or repair valves, such as the tricuspid valve, the pulmonary valve, the mitral valve, and the aortic valve. In some embodiments, one or more suturing devices can be used to perform a variety of operations, such as edge-to-edge repair (similar to the Alfieri technique), valvuloplasty (with or without a ring or other implant), ventricular space suturing, chordal suturing, suturing at other locations in the heart, chordal replacement, chordal shortening, patch application, leaflet reshaping, and prosthetic attachment, such as a ring and a biological or mechanical replacement valve.
在一些实施方案中，缝合装置可以用于闭合或缩小身体中多种其他组织开口、腔、中空器官或天然的或手术制造的通道。在一些实施方案中，缝合装置可以用于缝合身体中的修补物、合成材料或可植入装置。例如，所述装置可以用于缝合身体中的填料(pledget)。In some embodiments, the suturing device can be used to close or reduce a variety of other tissue openings, cavities, hollow organs, or natural or surgically created passages in the body. In some embodiments, the suturing device can be used to suturing a prosthesis, synthetic material, or implantable device in the body. For example, the device can be used to suturing a pledget in the body.
进入方法和装置Entry method and device
图1显示了缝合主动脉瓣4的示例性使用环境。也可以根据缝合其他身体组织的操作和缝合身体中的修补物、合成材料或可植入装置的操作对本文公开的用于缝合心脏瓣膜的装置和方法进行改造。如图1所示，可以使导丝10前进通过主动脉2到达位于或邻近主动脉瓣4的位置。可以使导丝10通过锁骨下动脉(未示出)前进之主动脉2中。应当考虑到，可以通过多种途径进入心脏。例如，可以通过下腔静脉3、上腔静脉5或其他血管途径进入心脏。导丝10就位后，医师可以将鞘12插入至位于或邻近主动脉瓣4的位置。鞘12通常是在近端具有阀的单腔导管。阀可以用于，例如，防止外部血液回流或向患者体内导入药物。然后，可以使缝合装置(例如下文进一步描述的那些装置)前进通过鞘12的腔。在可选实施方案中，缝合装置可以在导丝10上前进，并被置于位于或邻近主动脉瓣4的位置，而无需插入引导鞘12。FIG1 illustrates an exemplary use context for suturing an aortic valve 4. The devices and methods disclosed herein for suturing heart valves can also be modified for suturing other body tissues and for suturing prosthetics, synthetic materials, or implantable devices in the body. As shown in FIG1 , a guidewire 10 can be advanced through the aorta 2 to a location at or adjacent to the aortic valve 4. The guidewire 10 can be advanced into the aorta 2 via the subclavian artery (not shown). It should be understood that the heart can be accessed through a variety of routes. For example, the heart can be accessed through the inferior vena cava 3, the superior vena cava 5, or other vascular routes. Once the guidewire 10 is in place, the physician can insert the sheath 12 to a location at or adjacent to the aortic valve 4. The sheath 12 is typically a single-lumen catheter with a valve at its proximal end. The valve can be used, for example, to prevent external blood backflow or to introduce medications into the patient's body. A suturing device (such as those described further below) can then be advanced through the lumen of the sheath 12. In an alternative embodiment, the suturing device can be advanced over the guidewire 10 and positioned at or adjacent to the aortic valve 4 without inserting the introducer sheath 12.
图2A显示了另一缝合二尖瓣8的示例性使用环境。如图2A所示，导丝10通过左心室6的心尖7附近的穿刺口或切口9前进进入心脏的左心室6。可以通过限制性胸廓切开术、小套管针穿刺或小导管穿刺进入心脏。可以使用其他进入途径。然后，可以使导丝10进一步置于位于或邻近二尖瓣8的位置。导丝10就位后，医师可以将鞘12插入至左心室6。鞘12可以被置于位于或邻近二尖瓣8的位置。然后，可以使缝合装置前进通过鞘12的腔。在可选实施方案中，缝合装置可以在导丝10上前进，并被置于位于或邻近二尖瓣8的位置，而无需插入引导鞘12。Figure 2A shows another exemplary use environment for suturing the mitral valve 8. As shown in Figure 2A, the guidewire 10 advances into the left ventricle 6 of the heart through a puncture or incision 9 near the apex 7 of the left ventricle 6. Access to the heart can be achieved through restrictive thoracotomy, small trocar puncture, or small catheter puncture. Other access routes can be used. The guidewire 10 can then be further placed at a position located at or adjacent to the mitral valve 8. After the guidewire 10 is in place, the physician can insert the sheath 12 into the left ventricle 6. The sheath 12 can be placed at or adjacent to the mitral valve 8. The suturing device can then be advanced through the cavity of the sheath 12. In an optional embodiment, the suturing device can be advanced over the guidewire 10 and placed at or adjacent to the mitral valve 8 without inserting the guide sheath 12.
图2B显示了另一缝合二尖瓣8的示例性进入途径。如图所示2B，导丝10通过下腔静脉11前进进入心脏的右心房13，并通过邻近房间隔15的穿刺口或切口并进入左心房17。然后，可以使导丝10进一步置于位于或邻近二尖瓣8的位置。导丝10就位后，医师可以将鞘12插入至左心房17。鞘12可以被置于位于或邻近二尖瓣8的位置。然后，可以使缝合装置前进通过鞘12的腔。。在可选实施方案中，缝合装置可以在导丝10上前进，并被置于位于或邻近二尖瓣8的位置，而无需插入引导鞘12。在一些实施方案中，对于上文讨论的任何进入途径，可以不使用导丝插入装置。Figure 2B shows another exemplary access route for suturing the mitral valve 8. As shown in Figure 2B, the guidewire 10 is advanced through the inferior vena cava 11 into the right atrium 13 of the heart, and through a puncture or incision adjacent to the atrial septum 15 and into the left atrium 17. The guidewire 10 can then be further placed at a position located at or adjacent to the mitral valve 8. After the guidewire 10 is in place, the physician can insert the sheath 12 into the left atrium 17. The sheath 12 can be placed at a position located at or adjacent to the mitral valve 8. The suturing device can then be advanced through the cavity of the sheath 12. In an optional embodiment, the suturing device can be advanced over the guidewire 10 and placed at a position located at or adjacent to the mitral valve 8 without inserting the guide sheath 12. In some embodiments, for any of the access routes discussed above, the device can be inserted without a guidewire.
缝合装置和方法的实施方案，例如用于缝合瓣叶Embodiments of suturing devices and methods, for example for suturing valve leaflets
图3-9示出缝合装置100的实施方案，缝合装置100可以用于缝合解剖学瓣，例如心脏瓣膜。尽管将结合缝合解剖学瓣(例如心脏瓣膜)描述装置100，但装置100可以用于缝合其他生物组织以及可植入装置和材料。缝合装置100可以包括远侧组件102，一个或多个缝合线扣臂104(也标为104A，104B)以及一个或多个缝合线捕捉机构106(在一些实施方案中称为“针”)。每个臂可以具有与其连接的一个或多个缝合线部分130。缝合装置100还可以包括长形体(未示出)以便于从远处位置操控缝合线扣臂104和缝合线捕捉机构106。例如，长形体可以包括一个或多个腔以容纳一段缝合线或用于操控缝合线扣臂104和缝合线捕捉机构106或两者的一个或多个促动器杆。在一些实施方案中，远侧组件102可以包括所述长形体的一部分。Figures 3-9 show an embodiment of a suturing device 100, which can be used to suturing anatomical valves, such as heart valves. Although the device 100 will be described in conjunction with suturing anatomical valves (such as heart valves), the device 100 can be used to suturing other biological tissues and implantable devices and materials. The suturing device 100 may include a distal assembly 102, one or more suture clip arms 104 (also labeled 104A, 104B) and one or more suture capture mechanisms 106 (referred to as "needles" in some embodiments). Each arm may have one or more suture portions 130 connected thereto. The suturing device 100 may also include an elongated body (not shown) to facilitate manipulation of the suture clip arms 104 and the suture capture mechanism 106 from a remote location. For example, the elongated body may include one or more cavities to accommodate a length of suture or one or more actuator rods for manipulating the suture clip arms 104 and the suture capture mechanism 106 or both. In some embodiments, the distal assembly 102 may include a portion of the elongated body.
远侧组件102可以包括近侧座架108、远侧座架110、毂式件112以及外壳114(图6)。近侧座架108可以通过外壳114固定地连接于远侧座架110。毂式件112可以位于外壳114内，用于在近侧座架108和远侧座架110之间滑动运动。The distal assembly 102 may include a proximal mount 108, a distal mount 110, a hub 112, and a housing 114 ( FIG. 6 ). The proximal mount 108 may be fixedly coupled to the distal mount 110 via the housing 114. The hub 112 may be positioned within the housing 114 for sliding movement between the proximal mount 108 and the distal mount 110.
近侧座架108可以连接于长形体(未示出)。或者，长形体的远端可以形成近侧座架108或与近侧座架108整体成形。在一些实施方案中，长形体可以包括外壳114。近侧座架108可以包括一个或多个腔116，如图3和5所示。The proximal mount 108 can be connected to the elongated body (not shown). Alternatively, the distal end of the elongated body can form the proximal mount 108 or be integrally formed with the proximal mount 108. In some embodiments, the elongated body can include a housing 114. The proximal mount 108 can include one or more cavities 116, as shown in Figures 3 and 5.
毂式件112可以固定地连接于缝合线捕捉机构106和促动器杆118。促动器杆118可以运动通过近侧座架108中的腔116。因此，促动器杆118向远侧前进导致缝合线捕捉机构106向远侧前进。毂式件112可以包括一个或多个腔120。The hub 112 can be fixedly connected to the suture capture mechanism 106 and the actuator rod 118. The actuator rod 118 can be moved through a cavity 116 in the proximal mount 108. Thus, distal advancement of the actuator rod 118 causes distal advancement of the suture capture mechanism 106. The hub 112 can include one or more lumens 120.
缝合线扣臂104可以枢转地连接于远侧座架110，使得缝合线扣臂104可以在图3-4所示的缩回位置和图5-7A所示的伸出位置之间运动。虽然图3-9所示的装置100的臂104绕臂104的远端枢转，但是在其它实施方案中，臂104可以绕臂104的近端枢转。The suture clip arm 104 can be pivotally connected to the distal mount 110 such that the suture clip arm 104 can move between a retracted position shown in Figures 3-4 and an extended position shown in Figures 5-7A. Although the arm 104 of the device 100 shown in Figures 3-9 pivots about the distal end of the arm 104, in other embodiments, the arm 104 can pivot about the proximal end of the arm 104.
缝合线扣臂104可以连接于促动器杆124，促动器杆124可以运动通过近侧座架108中的腔116。臂104、远侧座架110以及杆124可以是连接的，使得杆124向远侧运动导致臂104伸出，杆124向近侧运动导致臂104收回。在一些实施方案中，臂104可以伸出至基本垂直于它们完全缩回位置的位置。在其他实施方案中，臂104可以在完全缩回位置和完全伸出位置之间运动少于90°。The suture clip arms 104 can be connected to an actuator rod 124 that can move through a cavity 116 in the proximal mount 108. The arms 104, the distal mount 110, and the rod 124 can be connected such that distal movement of the rod 124 causes the arms 104 to extend, and proximal movement of the rod 124 causes the arms 104 to retract. In some embodiments, the arms 104 can be extended to a position substantially perpendicular to their fully retracted position. In other embodiments, the arms 104 can move less than 90° between the fully retracted and fully extended positions.
远侧座架110可以包括一个或多个腔122(图5)，以允许缝合线捕捉机构106运动通过远侧座架110。另外地或可选地，一个或多个腔122可以容纳一段缝合线、促动器杆124或两者。The distal mount 110 can include one or more lumens 122 ( FIG. 5 ) to allow the suture capture mechanism 106 to move through the distal mount 110. Additionally or alternatively, the one or more lumens 122 can accommodate a length of suture, an actuator rod 124, or both.
缝合线扣臂104可以具有缝合线扣126，从而可释放地保持缝合线部分130。缝合线捕捉机构106可以前进而接合缝合线扣臂所保持的缝合线部分130。当缝合线捕捉机构106接合缝合线末端部分130时，缝合线捕捉机构106可以被收回，从而从缝合线扣126拉出缝合线端部。The suture clip arm 104 can have a suture clip 126 to releasably hold a suture portion 130. The suture capture mechanism 106 can be advanced to engage the suture portion 130 held by the suture clip arm. When the suture capture mechanism 106 engages the suture end portion 130, the suture capture mechanism 106 can be retracted to pull the suture end from the suture clip 126.
在一些实施方案中，缝合线扣126可以位于缝合线扣臂104上，使得缝合线捕捉机构106能收回缝合线扣126中保持的缝合线末端部分130，同时缝合线扣臂104从其完全伸出位置至少部分地收回。在一些实施方案中，缝合线扣126可以位于缝合线扣臂104上，使得缝合线捕捉机构106能收回缝合线扣126中保持的缝合线末端部分130，同时缝合线扣臂104被完全收回。在一些实施方案中，缝合线捕捉机构106可以在连续纵向的方向前进，从而接合缝合线扣臂104的缝合线扣126，同时缝合线扣臂被完全收回。在一些实施方案中，缝合线扣126可以位于绕缝合线扣臂的远端枢转的缝合线扣臂104的近侧相对一侧上。在一些实施方案中，缝合线扣126可以位于绕缝合线扣臂的近端枢转的缝合线扣臂104的远侧相对一侧上。In some embodiments, the suture catch 126 can be located on the suture clip arm 104 such that the suture capture mechanism 106 can retract the suture end portion 130 held in the suture catch 126 while the suture clip arm 104 is at least partially retracted from its fully extended position. In some embodiments, the suture catch 126 can be located on the suture clip arm 104 such that the suture capture mechanism 106 can retract the suture end portion 130 held in the suture catch 126 while the suture clip arm 104 is fully retracted. In some embodiments, the suture capture mechanism 106 can be advanced in a continuous longitudinal direction to engage the suture catch 126 of the suture clip arm 104 while the suture clip arm is fully retracted. In some embodiments, the suture catch 126 can be located on a proximal opposite side of the suture clip arm 104 that pivots about the distal end of the suture clip arm. In some embodiments, the suture catch 126 can be located on a distal opposite side of the suture clip arm 104 that pivots about the proximal end of the suture clip arm.
在一些实施方案中，缝合线扣臂104可以被配置为能容纳对应的缝合线捕捉机构106的组织穿刺部分。例如，在一些实施方案中，当缝合线捕捉机构106完全前进时，组织穿刺部分可以被对应的缝合线扣臂104完全容纳。在一些实施方案中，当臂至少部分地闭合时，缝合线扣臂104可以容纳缝合线捕捉机构106的组织穿刺部分。在一些实施方案中，当臂被完全收回时，缝合线扣臂104可以容纳缝合线捕捉机构106的组织穿刺部分。In some embodiments, the suture clip arms 104 can be configured to accommodate the tissue piercing portion of the corresponding suture capture mechanism 106. For example, in some embodiments, when the suture capture mechanism 106 is fully advanced, the tissue piercing portion can be fully accommodated by the corresponding suture clip arms 104. In some embodiments, when the arms are at least partially closed, the suture clip arms 104 can accommodate the tissue piercing portion of the suture capture mechanism 106. In some embodiments, when the arms are fully retracted, the suture clip arms 104 can accommodate the tissue piercing portion of the suture capture mechanism 106.
在一些实施方案中，当缝合线扣臂104被完全收回时，装置100可以包括缝合线扣臂104和远侧座架110或远侧组件102的其他部件之间的凹部140，如图7B所示。在一些实施方案中，当缝合线扣臂104被完全收回时，组织部分(例如瓣叶)可被凹部140容纳，并且不会损伤组织部分。在一些实施方案中，组织部分可以被缝合线扣臂104保持在凹部140中，同时缝合线扣臂104被完全收回。在一些实施方案中，组织部分可以被缝合线扣臂104保持在凹部140中，同时缝合线扣臂被至少部分地收回。In some embodiments, when the suture clip arm 104 is fully retracted, the device 100 can include a recess 140 between the suture clip arm 104 and the distal mount 110 or other component of the distal assembly 102, as shown in Figure 7B. In some embodiments, when the suture clip arm 104 is fully retracted, the tissue portion (e.g., a leaflet) can be accommodated by the recess 140 without damaging the tissue portion. In some embodiments, the tissue portion can be retained by the suture clip arm 104 in the recess 140 while the suture clip arm 104 is fully retracted. In some embodiments, the tissue portion can be retained by the suture clip arm 104 in the recess 140 while the suture clip arm is at least partially retracted.
在一些实施方案中，凹部140所具有的尺寸和形状可以在臂被至少部分地收回时在长形体和臂之间容纳瓣叶，而不会损伤瓣叶。在一些实施方案中，凹部140所具有的尺寸和形状可以在臂被完全收回时在长形体和臂之间容纳瓣叶，而不会损伤瓣叶。在一些实施方案中，凹部140所具有的尺寸和形状可以在臂被至少部分地收回时在长形体和臂之间保持瓣叶，而不会损伤瓣叶。在一些实施方案中，凹部140所具有的尺寸和形状可以在臂被完全收回时在长形体和臂之间保持瓣叶，而不会损伤瓣叶。In some embodiments, the recess 140 is sized and shaped to accommodate the leaflets between the elongated body and the arm when the arm is at least partially retracted without damaging the leaflets. In some embodiments, the recess 140 is sized and shaped to accommodate the leaflets between the elongated body and the arm when the arm is fully retracted without damaging the leaflets. In some embodiments, the recess 140 is sized and shaped to hold the leaflets between the elongated body and the arm when the arm is at least partially retracted without damaging the leaflets. In some embodiments, the recess 140 is sized and shaped to hold the leaflets between the elongated body and the arm when the arm is fully retracted without damaging the leaflets.
在一些实施方案中，缝合线扣臂104位于伸出位置时，可以操控装置100，将组织部分(例如瓣叶)置于缝合线扣臂104和远侧座架110之间，例如，如图11所示。在一些实施方案中，缝合线扣臂104可以绕组织部分至少部分地闭合。在一些实施方案中，缝合线扣臂104可以绕组织部分完全闭合。在一些实施方案中，缝合线扣臂104可以被至少部分地收回，从而将组织部分牢固地保持在缝合线扣臂104和远侧座架110之间。在一些实施方案中，缝合线扣臂104可以运动至缩回位置，从而将组织部分牢固地保持在缝合线扣臂104和远侧座架110之间，例如，如图12所示。在一些实施方案中，绕组织部分闭合缝合线扣臂104或将组织部分保持在缝合线扣臂104和远侧座架110之间不会损伤组织部分。In some embodiments, when the suture clip arms 104 are in the extended position, the device 100 can be manipulated to position a tissue portion (e.g., a leaflet) between the suture clip arms 104 and the distal mount 110, for example, as shown in FIG11. In some embodiments, the suture clip arms 104 can be at least partially closed around the tissue portion. In some embodiments, the suture clip arms 104 can be completely closed around the tissue portion. In some embodiments, the suture clip arms 104 can be at least partially retracted to securely hold the tissue portion between the suture clip arms 104 and the distal mount 110. In some embodiments, the suture clip arms 104 can be moved to a retracted position to securely hold the tissue portion between the suture clip arms 104 and the distal mount 110, for example, as shown in FIG12. In some embodiments, closing the suture clip arms 104 around the tissue portion or holding the tissue portion between the suture clip arms 104 and the distal mount 110 does not damage the tissue portion.
组织部分被保持在臂104和远侧座架110之间时，对应的缝合线捕捉机构106可以前进而接合由臂104的缝合线扣126保持的缝合线部分130，例如，如图13所示。然后，可以通过缝合线捕捉机构106将缝合线部分130拉回通过组织部分，例如，如图14所示。在其他实施方案中，当臂104处于伸出位置时，缝合线捕捉机构106可以向着缝合线扣臂104前进，并从缝合线扣126收回缝合线端部。在一些实施方案中，缝合线捕捉机构可以是针。When the tissue portion is held between the arm 104 and the distal mount 110, the corresponding suture capture mechanism 106 can be advanced to engage the suture portion 130 held by the suture clip 126 of the arm 104, as shown, for example, in FIG13. The suture portion 130 can then be pulled back through the tissue portion by the suture capture mechanism 106, as shown, for example, in FIG14. In other embodiments, when the arm 104 is in the extended position, the suture capture mechanism 106 can be advanced toward the suture clip arm 104 and withdraw the suture end from the suture clip 126. In some embodiments, the suture capture mechanism can be a needle.
在一些实施方案中，远侧组件102可以包括管或导管128，以容纳缝合线并防止装置100的任何部件损坏缝合线。在一些实施方案中，管128延伸通过近侧座架108中的腔116，远侧座架110中的腔120以及毂式件112中的腔122。In some embodiments, distal assembly 102 can include a tube or conduit 128 to house the suture and prevent damage to the suture by any component of device 100. In some embodiments, tube 128 extends through lumen 116 in proximal mount 108, lumen 120 in distal mount 110, and lumen 122 in hub 112.
关于可以与上述实施方案合并的装置、结构以及方法的更多细节提供在美国专利7,090,686和2008年10月30日公开的美国专利申请公开2008/0269786，通过引用的方式将上述文献整体并入本文并作为说明书的一部分。例如，在具有多个臂106和多个缝合线捕捉机构106的一些实施方案中，装置100的每个臂104和每个缝合线捕捉机构106可以被独立地促动，从而能在缩回位置和伸出位置之间单独地运动。Further details regarding devices, structures, and methods that can be incorporated with the above-described embodiments are provided in U.S. Patent No. 7,090,686 and U.S. Patent Application Publication No. 2008/0269786, published on October 30, 2008, which are incorporated herein by reference in their entirety and made a part of this specification. For example, in some embodiments having multiple arms 106 and multiple suture capturing mechanisms 106, each arm 104 and each suture capturing mechanism 106 of the device 100 can be independently actuated to be individually movable between a retracted position and an extended position.
图10-15示出根据一个实施方案的缝合解剖学瓣的方法。例如，该方法可以用于实施二尖瓣的缘至缘修复。缝合装置100的远端可以位于瓣叶132之间，如图10所示。可以利用上文讨论的任何进入途径使装置100前进通过血管到达需要的位置，利用或不利用导丝。例如，装置100可以前进通过下腔静脉进入右心房，并通过隔膜并定位于通过二尖瓣8的通道中(图2)。Figures 10-15 illustrate a method for suturing an anatomical valve according to one embodiment. For example, the method can be used to perform an edge-to-edge repair of a mitral valve. The distal end of the suturing device 100 can be positioned between the leaflets 132, as shown in Figure 10. The device 100 can be advanced through the blood vessel to the desired location using any of the access routes discussed above, with or without a guidewire. For example, the device 100 can be advanced through the inferior vena cava into the right atrium, through the septum and positioned in a passage through the mitral valve 8 (Figure 2).
可以使缝合装置100前进以允许缝合线扣臂104从远侧组件102伸出。然后，可以使缝合线扣臂104可以伸出，可以收回装置100直到缝合线扣臂104延伸围绕瓣的第一瓣叶132A和第二瓣叶132B，如图11所示。The suturing device 100 can be advanced to allow the suture clip arms 104 to extend from the distal assembly 102. The suture clip arms 104 can then be extended and the device 100 can be retracted until the suture clip arms 104 extend around the first and second leaflets 132A, 132B of the valve, as shown in FIG.
当缝合线扣臂104正确地围绕第一和第二瓣叶132时，可以收回缝合线扣臂104，从而捕获第一和第二瓣叶132的部分，例如捕获在缝合线扣臂104和远侧座架110之间、凹部140中，如图12所示。When the suture clip arm 104 is properly surrounded by the first and second leaflets 132, the suture clip arm 104 can be retracted to capture portions of the first and second leaflets 132, for example, between the suture clip arm 104 and the distal mount 110, in the recess 140, as shown in Figure 12.
当第一和第二瓣叶132被捕获时，可以使缝合线捕捉机构106从远侧组件102前进，以穿透第一和第二瓣叶132并接合缝合线扣臂104所保持的缝合线部分130，如图13所示。When the first and second leaflets 132 are captured, the suture capture mechanism 106 can be advanced from the distal assembly 102 to penetrate the first and second leaflets 132 and engage the suture portion 130 held by the suture clip arm 104, as shown in Figure 13.
缝合线部分130被接合之后，通过第一和第二瓣叶132的组织收回缝合线捕捉机构106和被接合的缝合线部分130，进入远侧组件102，如图14所示。缝合线扣臂104可以被伸出，以释放第一和第二瓣叶132。第一和第二瓣叶被释放后，可以使装置100稍稍前进，从而缝合线扣臂104可以运动至缩回位置，而不会夹紧瓣叶132。然后，可以将第一缝合装置100从瓣撤回。After the suture portions 130 are engaged, the suture capture mechanism 106 and the engaged suture portions 130 are withdrawn through the tissue of the first and second leaflets 132 and into the distal assembly 102, as shown in FIG14. The suture clip arms 104 can be extended to release the first and second leaflets 132. After the first and second leaflets are released, the device 100 can be slightly advanced so that the suture clip arms 104 can move to a retracted position without clamping the leaflets 132. The first suturing device 100 can then be withdrawn from the valve.
如图15所示，缝合装置100被撤回后，缝合线部分130从瓣叶132伸出。可以拉动缝合线部分130，将第一瓣叶132A和第二瓣叶132B朝向彼此拉近。然后，可以将缝合线部分130牢固地保持在一起，以限制瓣叶132A、132B相对于彼此运动，例如，如图15所示。在一些实施方案中，缝合线130可以使瓣叶132A、132B的一部分保持彼此接触。在其他实施方案中，缝合线130仅使瓣叶132A、132B彼此比之前更为接近。可以通过系出结134使缝合线部分130牢固地保持在一起，可以按照任何已知的方法或通过施加结134，例如描述于2007年1月11日公开的美国专利公布2007/0010829A1，通过引用的方式将上述文献整体并入本文并作为说明书的一部分。可以在身体外部或身体内部将缝合线部分130牢固地保持在一起。可以修整缝合线130的任何多余部分。在一些实施方案中，在系结或施加结之前或之后，可以将一个或多个填料(pledget)附接到缝合线部分130，并定位于结134的远侧和/或近侧。As shown in FIG15 , after the suturing device 100 is withdrawn, the suture portion 130 extends from the leaflet 132. The suture portion 130 can be pulled to draw the first leaflet 132A and the second leaflet 132B toward each other. The suture portion 130 can then be securely held together to restrict movement of the leaflets 132A, 132B relative to each other, for example, as shown in FIG15 . In some embodiments, the suture 130 can hold a portion of the leaflets 132A, 132B in contact with each other. In other embodiments, the suture 130 only brings the leaflets 132A, 132B closer to each other than before. The suture portion 130 can be securely held together by tying a knot 134, which can be done by any known method or by applying the knot 134, such as described in U.S. Patent Publication 2007/0010829A1, published on January 11, 2007, which is incorporated herein by reference in its entirety and made a part of this specification. Suture portion 130 can be held securely together outside or inside the body. Any excess suture 130 can be trimmed. In some embodiments, one or more pledgets can be attached to suture portion 130 and positioned distally and/or proximally of knot 134 before or after tying or applying the knot.
图16显示了可以用于缝合解剖学瓣(例如心脏瓣膜)的装置的系统的实施方案。在一些实施方案中，所述装置可以包括在用于缝合解剖学瓣的装置的系统中，例如图16所示的系统。图16的系统包括两个缝合装置1100A、B，每一个缝合装置可以包括远侧组件1102A、B，单个缝合线扣臂1104A、B以及单个缝合线捕捉机构1106A、B(图21和25所示)。本文中对缝合装置1100A或1100B的其他描述可以忽略编号后的字母A或B，因为可以理解到所描述的部件可以指任一装置。Figure 16 shows an embodiment of a system of devices that can be used to sew anatomical valves (e.g., heart valves). In some embodiments, the device can be included in a system of devices for sew anatomical valves, such as the system shown in Figure 16. The system of Figure 16 includes two suturing devices 1100A, B, each of which can include a distal assembly 1102A, B, a single suture clip arm 1104A, B, and a single suture capture mechanism 1106A, B (shown in Figures 21 and 25). Other descriptions of the suturing devices 1100A or 1100B herein may omit the letters A or B after the number, as it will be understood that the components described can refer to either device.
所述装置可以大体上相似，但区别至少在于，相对于它们的手柄1144，每个缝合装置的单个缝合线扣臂1104的定向大体上与另一缝合装置的缝合线扣臂1104是相对的。如图所示，装置具有不同长度的长型体，但在其他实施方案中，长型体可以为基本相同的长度。所述系统还可以包括缝合线连接装置135，其可以用于向两个或更多个缝合线末端施加结或以其他方式连接两个或更多个缝合线末端。关于用于连接缝合线的装置的更多细节提供在2011年8月4日公开的美国专利申请公开2011/0190793，通过引用的方式将上述文献整体并入本文并作为说明书的一部分。另外，用于连接缝合线的装置的描述可以见于下文以及参考图117-119。The devices can be generally similar, but differ in that, relative to their handles 1144, the orientation of the individual suture clip arms 1104 of each suturing device is generally opposite to the suture clip arms 1104 of the other suturing devices. As shown, the devices have elongated bodies of different lengths, but in other embodiments, the elongated bodies can be substantially the same length. The system can also include a suture connecting device 135, which can be used to apply a knot to two or more suture ends or otherwise connect two or more suture ends. More details about the device for connecting sutures are provided in U.S. Patent Application Publication 2011/0190793, published on August 4, 2011, which is incorporated herein by reference in its entirety and made a part of this specification. Additionally, a description of the device for connecting sutures can be found below and with reference to Figures 117-119.
缝合装置1100A、B可以包括长形体1142以便于在远处位置操控缝合线扣臂1104和缝合线捕捉机构(不可见)。例如，长形体可以包括一个或多个腔，以容纳一段缝合线或用于操控缝合线扣臂1104和缝合线捕捉机构或两者的一个或多个促动器杆。The suturing device 1100A, B can include an elongated body 1142 to facilitate remote manipulation of the suture clip arm 1104 and the suture capture mechanism (not visible). For example, the elongated body can include one or more lumens to accommodate a length of suture or one or more actuator rods for manipulating the suture clip arm 1104 and the suture capture mechanism or both.
缝合装置1100A、B可以包括手柄1144，手柄1144具有一个或多个促动器和/或拉动件(pull)1146，用于运动缝合线扣臂1104和缝合线捕捉机构1106。在各个实施方案中，手柄可以具有不同形状和构型，例如图16的手柄或图17所示的手柄。关于手柄以及相关部件(包括促动器杆)的更多细节提供于2008年10月30日公开的美国专利申请公开2008/0269786，通过引用的方式将上述文献整体并入本文并作为说明书的一部分。The suturing device 1100A, B can include a handle 1144 having one or more actuators and/or pulls 1146 for moving the suture clip arm 1104 and the suture capture mechanism 1106. In various embodiments, the handle can have different shapes and configurations, such as the handle of FIG16 or the handle shown in FIG17. Further details regarding the handle and related components (including the actuator rod) are provided in U.S. Patent Application Publication No. 2008/0269786, published on October 30, 2008, which is incorporated herein by reference in its entirety and made a part of this specification.
图18显示了一种缝合装置1100A的远侧组件1102A，其中缝合线扣臂1104A处于伸出位置。在一些实施方案中，缝合线扣臂1104A可以绕位于缝合线扣臂1104A的远端的轴枢转，从而使缝合线扣臂1104A从缩回位置运动至伸出位置，如图18所示。相同的描述可以适用于另一缝合装置1100B。FIG18 shows a distal assembly 1102A of a suturing device 1100A with the suture clip arm 1104A in an extended position. In some embodiments, the suture clip arm 1104A can pivot about an axis located at the distal end of the suture clip arm 1104A, thereby moving the suture clip arm 1104A from the retracted position to the extended position, as shown in FIG18. The same description can be applied to another suturing device 1100B.
图19-27示出按照一个实施方案的缝合解剖学瓣(例如二尖瓣的缘至缘修复)的方法。尽管所示方法涉及两个装置1100A、B，每个装置具有单个缝合线扣臂1104和单个缝合线捕捉机构1106，但是利用具有多个臂1104和多个缝合线捕捉机构1106的单个缝合装置1100也可以实施所示方法，下文会进一步描述。19-27 illustrate a method for suturing an anatomical valve (e.g., an edge-to-edge repair of a mitral valve) according to one embodiment. Although the illustrated method involves two devices 1100A, B, each having a single suture clip arm 1104 and a single suture capture mechanism 1106, the illustrated method can also be performed using a single suturing device 1100 having multiple arms 1104 and multiple suture capture mechanisms 1106, as further described below.
第一缝合装置1100A的远端可以位于瓣的瓣叶132之间，如图19所示。可以利用上文讨论的任何进入途径使装置1100A前进通过血管到达需要的位置(利用或不利用导丝)。例如，装置1100A可以前进通过下腔静脉进入右心房，并通过隔，定位于通过二尖瓣8的通道中(图2)。The distal end of the first suturing device 1100A can be positioned between the leaflets 132 of the valve, as shown in FIG19 . The device 1100A can be advanced through the blood vessel to the desired location (with or without a guidewire) using any of the access routes discussed above. For example, the device 1100A can be advanced through the inferior vena cava into the right atrium and through the septum to be positioned in the passage through the mitral valve 8 ( FIG2 ).
可以使缝合装置1100A前进以允许缝合线扣臂1104A从远侧组件1102A伸出。然后，可以使缝合线扣臂1104A伸出，可以收回装置1100A直到缝合线扣臂1104A延伸围绕瓣的第一瓣叶132A，如图20所示。The suturing device 1100A can be advanced to allow the suture clip arm 1104A to extend from the distal assembly 1102A. The suture clip arm 1104A can then be extended and the device 1100A can be retracted until the suture clip arm 1104A extends around the first leaflet 132A of the valve, as shown in FIG.
当缝合线扣臂1104A正确地围绕第一瓣叶132A时，可以使缝合线捕捉机构1106A从远侧组件1102A前进，以穿透第第一瓣叶132A并接合缝合线扣臂1104A所保持的缝合线部分130A，如图21所示。在一些实施方案中，可以使缝合线扣臂1104A运动至缩回位置，从而将第一瓣叶132A的一部分牢固地保持在臂1104A和长形体之间，例如，在缝合线捕捉机构1106A前进通过第一瓣叶132A而接合缝合线端部之前，如上文所述。When the suture clip arm 1104A is properly positioned around the first leaflet 132A, the suture capture mechanism 1106A can be advanced from the distal assembly 1102A to penetrate the first leaflet 132A and engage the suture portion 130A held by the suture clip arm 1104A, as shown in Figure 21. In some embodiments, the suture clip arm 1104A can be moved to a retracted position, thereby securely holding a portion of the first leaflet 132A between the arm 1104A and the elongated body, e.g., before the suture capture mechanism 1106A is advanced through the first leaflet 132A to engage the suture end, as described above.
缝合线部分130A被接合之后，通过第一瓣叶132A的组织收回缝合线捕捉机构1106A和被接合的缝合线部分130A，进入远侧组件1102A，如图22所示。可以使装置1100A稍稍前进，从而缝合线扣臂1104A可以运动至缩回位置，而不会夹紧第一瓣叶132A。然后，可以将第一缝合装置1100A从瓣撤回。After the suture portion 130A is engaged, the suture capture mechanism 1106A and the engaged suture portion 130A are withdrawn through the tissue of the first leaflet 132A and into the distal assembly 1102A, as shown in Figure 22. The device 1100A can be advanced slightly so that the suture clip arms 1104A can move to a retracted position without clamping the first leaflet 132A. The first suturing device 1100A can then be withdrawn from the valve.
然后，可以使第二缝合装置1100B前进至心脏中并位于瓣的瓣叶132A、132B之间，如图23所示。然后，可以伸出缝合线扣臂1104B，并且可以使装置1100B前进，使得缝合线扣臂1104B延伸围绕第二瓣叶132B的尖端，如图24所示。The second suturing device 1100B can then be advanced into the heart and positioned between the leaflets 132A, 132B of the valve, as shown in Figure 23. The suture clip arms 1104B can then be extended and the device 1100B can be advanced so that the suture clip arms 1104B extend around the tips of the second leaflets 132B, as shown in Figure 24.
当缝合线扣臂1104B正确地围绕第二瓣叶132B时，可以使缝合线捕捉机构1106B从远侧组件1102B前进，以穿透第二瓣叶132B并接合缝合线扣臂1104B所保持的缝合线部分130B，如图25所示。上文关于第一瓣叶132A应当注意到，在一些实施方案中，在缝合线捕捉机构1106B前进通过第二瓣叶132B而接合缝合线部分130B之前，可以使缝合线扣臂1104B运动至缩回位置，从而将第二瓣叶132B的一部分牢固地保持在臂1104B和远侧组件1102B之间。When the suture clip arm 1104B is properly positioned around the second leaflet 132B, the suture capture mechanism 1106B can be advanced from the distal assembly 1102B to penetrate the second leaflet 132B and engage the suture portion 130B held by the suture clip arm 1104B, as shown in Figure 25. It should be noted above with respect to the first leaflet 132A that, in some embodiments, the suture clip arm 1104B can be moved to a retracted position, thereby securely holding a portion of the second leaflet 132B between the arm 1104B and the distal assembly 1102B, before the suture capture mechanism 1106B is advanced through the second leaflet 132B to engage the suture portion 130B.
缝合线部分130B被接合之后，通过第二瓣叶132B的组织收回缝合线捕捉机构1106B和被接合的缝合线部分130B，进入远侧组件1102B，如图26所示。使装置1100B稍稍前进之后，可以闭合缝合线扣臂1104B可以，以避免当闭合臂1104B时夹紧第二瓣叶132B。当缝合线扣臂1104B闭合时，可以从患者心脏撤回缝合装置1100B。After the suture portion 130B is engaged, the suture capture mechanism 1106B and the engaged suture portion 130B are retracted through the tissue of the second leaflet 132B and into the distal assembly 1102B, as shown in FIG26. After the device 1100B is slightly advanced, the suture clip arms 1104B can be closed to avoid pinching the second leaflet 132B when closing the arms 1104B. When the suture clip arms 1104B are closed, the suturing device 1100B can be withdrawn from the patient's heart.
如图27所示，缝合装置1100B被撤回后，缝合线部分130A、B会从瓣叶132A、132B向近侧伸出。然后，可以将缝合线部分130A、B牢固地保持在一起，如图27所示，通过按照任何已知的方法系出结134或通过施加结134。在一些实施方案中，在系结或施加结之前或之后，可以将一个或多个填料附接到缝合线部分130A、B，并定位于结134的远侧和/或近侧。可以在身体外部或身体内部将缝合线部分130A、B牢固地保持在一起。可以修整缝合线130的任何多余部分。然后，可以拉动缝合线部分130A、B，将第一瓣叶132A和第二瓣叶132B朝向彼此拉近。然后，可以系出第二个结或向缝合线130施加第二个结，以限制瓣叶132A，132B相对于彼此运动，如上文所述。在一些实施方案中，缝合线130可以可以使瓣叶132A、132B的一部分保持彼此接触。在其他实施方案中，缝合线130仅使瓣叶132A、132B彼此比之前更为接近。As shown in Figure 27, after the suturing device 1100B is withdrawn, the suture portions 130A, B will extend proximally from the leaflets 132A, 132B. The suture portions 130A, B can then be securely held together, as shown in Figure 27, by tying a knot 134 or applying a knot 134 according to any known method. In some embodiments, one or more fillers can be attached to the suture portions 130A, B before or after tying or applying the knot and positioned distally and/or proximally of the knot 134. The suture portions 130A, B can be securely held together outside or inside the body. Any excess portion of the suture 130 can be trimmed. The suture portions 130A, B can then be pulled to draw the first leaflet 132A and the second leaflet 132B toward each other. A second knot can then be tied or applied to the suture 130 to restrict movement of the leaflets 132A, 132B relative to each other, as described above. In some embodiments, suture 130 can hold a portion of leaflets 132A, 132B in contact with each other. In other embodiments, suture 130 only brings leaflets 132A, 132B closer to each other than before.
但使用具有多个臂和多个缝合线捕捉机构的装置时，装置可以被配置为能使单个缝合线130通过第一瓣叶132A和第二瓣叶132B。可以使单个缝合线130可以同时或依次通过第一和第二瓣叶132。在一些实施方案中，可以拉动缝合线部分130，将第一瓣叶132A和第二瓣叶132B朝向彼此拉近，而不事先向缝合线130施加结。因此，可以向缝合线130施加单个结134来保持瓣叶132A、132B彼此接近。However, when using a device with multiple arms and multiple suture capturing mechanisms, the device can be configured to pass a single suture 130 through the first leaflet 132A and the second leaflet 132B. The single suture 130 can be passed through the first and second leaflets 132 simultaneously or sequentially. In some embodiments, the suture portion 130 can be pulled to draw the first and second leaflets 132A, 132B toward each other without first applying a knot to the suture 130. Thus, a single knot 134 can be applied to the suture 130 to hold the leaflets 132A, 132B close to each other.
图28和29示出可以用于缝合解剖学瓣(例如心脏瓣膜)的缝合装置2100A的实施方案。图28和29所示的缝合装置2100A在某些方面与上文说明和描述的缝合装置相似。例如，与图17和18的缝合装置1100一样，图28和29的缝合装置2100A可以包括远侧组件2102A、单个缝合线扣臂2104A以及单个缝合线捕捉机构2106A。Figures 28 and 29 illustrate an embodiment of a suturing device 2100A that can be used to suturing an anatomical valve (e.g., a heart valve). The suturing device 2100A shown in Figures 28 and 29 is similar in some respects to the suturing device illustrated and described above. For example, like the suturing device 1100 of Figures 17 and 18, the suturing device 2100A of Figures 28 and 29 can include a distal assembly 2102A, a single suture clip arm 2104A, and a single suture capture mechanism 2106A.
如图28和29所示，缝合装置2100A可以包括长形体2142A以便于在远处位置操控缝合线扣臂2104A和缝合线捕捉机构2106A。例如，长形体可以包括一个或多个腔，以容纳一段缝合线或用于操控缝合线扣臂2104A和缝合线捕捉机构2106A或两者的一个或多个促动器杆。缝合装置2100A可以包括手柄，手柄具有一个或多个促动器和/或拉动件(pull)2146A，用于运动缝合线扣臂2104A和缝合线捕捉机构2106A。关于手柄以及相关部件(包括促动器杆)的更多细节提供于2008年10月30日公开的美国专利申请公开2008/0269786，通过引用的方式将上述文献整体并入本文并作为说明书的一部分。As shown in Figures 28 and 29, the suturing device 2100A may include an elongated body 2142A to facilitate manipulation of the suture clip arm 2104A and the suture capture mechanism 2106A at a remote location. For example, the elongated body may include one or more cavities to accommodate a length of suture or one or more actuator rods for manipulating the suture clip arm 2104A and the suture capture mechanism 2106A or both. The suturing device 2100A may include a handle having one or more actuators and/or pulls 2146A for moving the suture clip arm 2104A and the suture capture mechanism 2106A. More details about the handle and related components (including the actuator rods) are provided in U.S. Patent Application Publication 2008/0269786, published on October 30, 2008, which is incorporated herein by reference in its entirety and made a part of this specification.
在一些实施方案中，当缝合线扣臂2104A处于缩回位置时，缝合线扣臂2104A可以绕位于缝合线扣臂2104A的近端的轴枢转，如图28和29所示。In some embodiments, when the suture clip arm 2104A is in the retracted position, the suture clip arm 2104A can pivot about an axis located at the proximal end of the suture clip arm 2104A, as shown in Figures 28 and 29.
图30-37示出缝合解剖学瓣(例如二尖瓣的缘至缘修复)的方法。尽管所示方法涉及装置2100A、B，每个装置具有单个缝合线扣臂2104A、B和单个缝合线捕捉机构2106A、B，但是利用具有多个臂2104和多个缝合线捕捉机构2106的装置2100也可以实施所示方法，例如，如上文所讨论的。30-37 illustrate a method for suturing an anatomical valve, such as a mitral valve edge-to-edge repair. Although the illustrated method involves devices 2100A, B, each having a single suture clip arm 2104A, B and a single suture capture mechanism 2106A, B, the illustrated method can also be implemented using a device 2100 having multiple arms 2104 and multiple suture capture mechanisms 2106, for example, as discussed above.
第一缝合装置2100A的远端可以位于瓣的瓣叶132之间，如图30所示。可以利用上文讨论的任何进入途径使装置2100A前进通过血管到达需要的位置(利用或不利用导丝)。例如，装置2100A可以前进通过锁骨下动脉进入主动脉，从而将装置2100A置于通过主动脉瓣4的通道中(图1)。或者，可以通过心脏中的穿刺口或小切口9插入装置2100A，从而将装置2100A置于通过二尖瓣8的通道中，如图2所示。所述穿刺口可以位于心脏7的心尖或邻近心脏7的心尖。The distal end of the first suturing device 2100A can be located between the leaflets 132 of the valve, as shown in Figure 30. Any of the access routes discussed above can be used to advance the device 2100A through the blood vessel to the desired location (with or without a guidewire). For example, the device 2100A can be advanced through the subclavian artery into the aorta, thereby placing the device 2100A in a passage through the aortic valve 4 (Figure 1). Alternatively, the device 2100A can be inserted through a puncture or small incision 9 in the heart, thereby placing the device 2100A in a passage through the mitral valve 8, as shown in Figure 2. The puncture port can be located at the apex of the heart 7 or adjacent to the apex of the heart 7.
如图30所示，可以定位缝合装置2100A以允许缝合线扣臂2104A从远侧组件2102A伸出。然后，可以使缝合线扣臂2104A伸出，可以使装置2100A前进直到缝合线扣臂2104A延伸围绕瓣的第一瓣叶132A，如图31所示。As shown in Figure 30, the suturing device 2100A can be positioned to allow the suture clip arm 2104A to extend from the distal assembly 2102A. The suture clip arm 2104A can then be extended and the device 2100A can be advanced until the suture clip arm 2104A extends around the first leaflet 132A of the valve, as shown in Figure 31.
当缝合线扣臂2104A正确地围绕第一瓣叶132A时，可以使缝合线捕捉机构2106A从远侧组件2102A前进，以穿透第一瓣叶132A并接合缝合线扣臂2104A所保持的缝合线部分130A，如图32所示。在一些实施方案中，在缝合线捕捉机构2106A前进通过the第一瓣叶132A而接合缝合线端部之前，可以使缝合线扣臂2104A运动至缩回位置，从而将第一瓣叶132A的一部分牢固地保持在臂2104A和远侧组件2102A之间，例如，如上文所述。When the suture clip arm 2104A is properly positioned around the first leaflet 132A, the suture capture mechanism 2106A can be advanced from the distal assembly 2102A to penetrate the first leaflet 132A and engage the suture portion 130A held by the suture clip arm 2104A, as shown in Figure 32. In some embodiments, before the suture capture mechanism 2106A is advanced through the first leaflet 132A to engage the suture end, the suture clip arm 2104A can be moved to a retracted position, thereby securely holding a portion of the first leaflet 132A between the arm 2104A and the distal assembly 2102A, e.g., as described above.
如图33所示，缝合线部分130A被接合之后，通过第一瓣叶132A的组织收回缝合线捕捉机构2106A和被接合的缝合线部分130A，进入远侧组件2102A。可以使装置2100A稍稍收回，从而缝合线扣臂2104A可以运动至缩回位置，而不会夹紧第一瓣叶132A。然后，可以将第一缝合装置2100A从瓣撤回。As shown in FIG33 , after the suture portion 130A is engaged, the suture capture mechanism 2106A and the engaged suture portion 130A are withdrawn through the tissue of the first leaflet 132A and into the distal assembly 2102A. The device 2100A can be slightly retracted so that the suture clip arms 2104A can move to a retracted position without clamping the first leaflet 132A. The first suturing device 2100A can then be withdrawn from the valve.
然后，可以使第二缝合装置2100B前进至心脏中并位于瓣的瓣叶132A、132B之间，如图34所示。然后，可以伸出缝合线扣臂2104B，并且可以使装置2100B前进，使得缝合线扣臂2104B延伸围绕第二瓣叶132B的尖端，如图35所示。The second suturing device 2100B can then be advanced into the heart and positioned between the leaflets 132A, 132B of the valve, as shown in Figure 34. The suture clip arms 2104B can then be extended and the device 2100B can be advanced so that the suture clip arms 2104B extend around the tips of the second leaflets 132B, as shown in Figure 35.
在所示实施方案中，当缝合线扣臂2104B正确地围绕第二瓣叶132B时，可以使缝合线捕捉机构2106B从远侧组件2102B前进，以穿透第二瓣叶132B并接合缝合线扣臂2104B所保持的缝合线部分130B，如图36所示。上文关于第一瓣叶132A应当注意到，在一些实施方案中，在缝合线捕捉机构2106B前进通过第二瓣叶132B而接合缝合线部分130B之前，可以使缝合线扣臂2104B运动至缩回位置，从而将第二瓣叶132B的一部分牢固地保持在臂2104B和远侧组件2102B之间。In the illustrated embodiment, when the suture clip arm 2104B is properly positioned around the second leaflet 132B, the suture capture mechanism 2106B can be advanced from the distal assembly 2102B to penetrate the second leaflet 132B and engage the suture portion 130B held by the suture clip arm 2104B, as shown in Figure 36. As noted above with respect to the first leaflet 132A, in some embodiments, the suture clip arm 2104B can be moved to a retracted position, thereby securely holding a portion of the second leaflet 132B between the arm 2104B and the distal assembly 2102B, before the suture capture mechanism 2106B is advanced through the second leaflet 132B to engage the suture portion 130B.
缝合线部分130B被接合之后，通过第二瓣叶132B的组织向远侧收回缝合线捕捉机构2106B和被接合的缝合线部分130B，进入远侧组件2102B，如图37所示。稍稍收回装置2100B之后，可以闭合缝合线扣臂2104B，以避免夹紧第二瓣叶132B。当缝合线扣臂2104B闭合时，可以从患者心脏撤回缝合装置2100B。After the suture portion 130B is engaged, the suture capture mechanism 2106B and the engaged suture portion 130B are withdrawn distally through the tissue of the second leaflet 132B and into the distal assembly 2102B, as shown in FIG 37. After slightly withdrawing the device 2100B, the suture clip arms 2104B can be closed to avoid clamping the second leaflet 132B. When the suture clip arms 2104B are closed, the suturing device 2100B can be withdrawn from the patient's heart.
在一些实施方案中，缝合装置3100可以具有多个臂3104。在一些实施方案中，臂可以绕长形体的周边以不同的间隔隔开。在一些实施方案中，多个臂可以从长形体的一侧伸出，对应的多个臂可以从长形体的对侧伸出。图38A和38B示出具有两个臂3104A、B的缝合装置3100的视图。如图所示，臂绕长形体3142彼此间隔约180度。在一些实施方案中，缝合装置可以具有两个缝合线捕捉机构3106A、B，每个缝合线捕捉机构与每个臂相关联。装置可以被设计为能使多个臂同时展开，以及多个缝合线捕捉机构同时展开。或者，装置可以被设计为能使每个臂和每个缝合线捕捉机构可以单独展开。在一些实施方案中，缝合装置可以作为具有缝合线连接装置135的系统，如结合图16所讨论的。该缝合装置的很多方面可以与结合图28-37所描述的装置以基本相似的方式工作。除非另外讨论，部件可以被认为与结合图28-37所描述的相似标记的部件具有相同的功能并以基本相似的的方式工作。作为非限制性实例，装置可以包括远侧组件3102和手柄，手柄具有一个或多个促动器和/或拉动件(pull)3146，用于运动缝合线扣臂3104和展开缝合线捕捉机构3106。In some embodiments, the suturing device 3100 may have multiple arms 3104. In some embodiments, the arms may be spaced at different intervals around the periphery of the elongated body. In some embodiments, multiple arms may extend from one side of the elongated body, and corresponding multiple arms may extend from the opposite side of the elongated body. Figures 38A and 38B show views of a suturing device 3100 with two arms 3104A, B. As shown, the arms are spaced approximately 180 degrees apart around the elongated body 3142. In some embodiments, the suturing device may have two suture capture mechanisms 3106A, B, each associated with each arm. The device may be designed to enable multiple arms to be deployed simultaneously, and multiple suture capture mechanisms to be deployed simultaneously. Alternatively, the device may be designed to enable each arm and each suture capture mechanism to be deployed separately. In some embodiments, the suturing device may be a system having a suture connection device 135, as discussed in conjunction with Figure 16. Many aspects of this suturing device may work in a substantially similar manner to the device described in conjunction with Figures 28-37. Unless otherwise discussed, components may be considered to have the same function and operate in a substantially similar manner as similarly labeled components described in connection with Figures 28-37. As a non-limiting example, the device may include a distal assembly 3102 and a handle having one or more actuators and/or pulls 3146 for moving the suture clip arm 3104 and deploying the suture capture mechanism 3106.
在一些实施方案中，缝合装置可以具有图39A和39B所示的远侧组件3102’。图39A显示了具有两个缝合臂3104A’、B’的装置，缝合臂3104A’、B’处于缩回位置。在图39B中，缝合臂3104A’、B’都处于伸出位置，缝合线捕捉机构3106A’、B’已通过对应的臂在缝合线扣3126A’、B’处伸出。在一些实施方案中，臂可以同时或依次伸出和收回，在一些实施方案中，缝合线捕捉机构可以同时或依次伸出和收回。如图所示，在一些实施方案中，缝合装置可以包括在远端的渐缩形部分3113’和/或导丝腔3111’，如果装置在导丝上前进，则可以使用导丝腔3111’。In some embodiments, the suturing device can have a distal assembly 3102' as shown in Figures 39A and 39B. Figure 39A shows a device having two suturing arms 3104A', B', which are in a retracted position. In Figure 39B, the suturing arms 3104A', B' are both in an extended position, and the suture capture mechanisms 3106A', B' have been extended at the suture buckles 3126A', B' via their respective arms. In some embodiments, the arms can be extended and retracted simultaneously or sequentially, and in some embodiments, the suture capture mechanisms can be extended and retracted simultaneously or sequentially. As shown, in some embodiments, the suturing device can include a tapered portion 3113' and/or a guidewire lumen 3111' at the distal end, which can be used if the device is advanced over a guidewire.
图40-47示出利用双重臂缝合装置缝合解剖学瓣(例如二尖瓣的缘至缘修复)的方法。该方法是参照图38A和38B的缝合装置3100进行描述的，但可以使用任何双重臂缝合装置，例如具有参照图39A和39B描述的远侧组件的双重臂缝合装置。可以通过上文参照图30-37的方法所讨论的任何方法使缝合装置3100前进至瓣的瓣叶132之间需要的位置(如图40所示)，并且可以利用或不利用导丝。在所示实施方案中，可以将缝合装置3100经心尖递送至左心室中，并使得装置的远端延伸通过二尖瓣进入左心房。但是，该装置也可以为适合于通过右心房和左心房之间的房间隔、通过二尖瓣并进入左心室的方法。可以基于所需要的途径方法并基于所要缝合的目标位置合适地设计缝合线扣臂3104和缝合线捕捉机构3106的位置和配置。例如，尽管图40的实施方案中的臂3104显示为位于缝合线捕捉机构3106的近侧，但是在不同的装置中，臂3104可以位于缝合线捕捉机构的远侧。Figures 40-47 illustrate a method for suturing an anatomical valve (e.g., edge-to-edge repair of a mitral valve) using a dual-arm suturing device. The method is described with reference to the suturing device 3100 of Figures 38A and 38B, but any dual-arm suturing device may be used, such as a dual-arm suturing device having a distal assembly described with reference to Figures 39A and 39B. The suturing device 3100 can be advanced to the desired position between the leaflets 132 of the valve (as shown in Figure 40) by any of the methods discussed above with reference to Figures 30-37, and with or without a guidewire. In the illustrated embodiment, the suturing device 3100 can be delivered transapically into the left ventricle with the distal end of the device extending through the mitral valve into the left atrium. However, the device can also be a method suitable for passing through the atrial septum between the right atrium and the left atrium, through the mitral valve, and into the left ventricle. The position and configuration of the suture clip arms 3104 and the suture capture mechanism 3106 can be appropriately designed based on the desired approach and based on the target location to be sutured. For example, although the arms 3104 in the embodiment of FIG. 40 are shown as being located proximal to the suture capture mechanism 3106, in a different arrangement, the arms 3104 may be located distal to the suture capture mechanism.
对于缝合图40所示的二尖瓣，装置的定位可以使得缝合线扣臂中的至少一个(第一臂3104A)能从装置伸出，并且装置可以前进直至第一臂3104A延伸围绕或邻近瓣132A的第一瓣叶，如图41所示。因此，当缝合二尖瓣时，臂3104A可以位于瓣叶132A的近侧或心室侧。臂3104A携带缝合线部分130A的端部。在图40中，臂3104A正独立于臂3104B而展开，但是在其他实施方案中，两个臂可以一起展开。For suturing the mitral valve shown in Figure 40, the device can be positioned so that at least one of the suture clip arms (first arm 3104A) can extend from the device, and the device can be advanced until the first arm 3104A extends around or adjacent to the first leaflet of the valve 132A, as shown in Figure 41. Therefore, when suturing the mitral valve, the arm 3104A can be located on the proximal or ventricular side of the leaflet 132A. The arm 3104A carries the end of the suture portion 130A. In Figure 40, the arm 3104A is being deployed independently of the arm 3104B, but in other embodiments, the two arms can be deployed together.
如结合图32所述，当第一缝合线扣臂3104A正确定位后，缝合线捕捉机构3106A可以从远侧组件3102、从位于瓣叶132A远侧的位置(或者对于二尖瓣操作，在瓣叶的心房侧)前进，从而穿透第一瓣叶132A并接合第一缝合线扣臂3104A所保持的缝合线部分130A，如图42所示。在一些实施方案中，在缝合线捕捉机构3106A前进通过第一瓣叶132A而接合缝合线端部之前，可以使第一缝合线扣臂3104A运动至缩回位置，从而将第一瓣叶132A的一部分牢固地保持在第一臂3104A和远侧组件3102之间。32 , once the first suture clip arm 3104A is properly positioned, the suture capture mechanism 3106A can be advanced from the distal assembly 3102, from a position distal to the leaflet 132A (or, for mitral valve procedures, on the atrial side of the leaflet), to penetrate the first leaflet 132A and engage the suture portion 130A held by the first suture clip arm 3104A, as shown in FIG 42 . In some embodiments, before the suture capture mechanism 3106A is advanced through the first leaflet 132A to engage the suture end, the first suture clip arm 3104A can be moved to a retracted position, thereby securely holding a portion of the first leaflet 132A between the first arm 3104A and the distal assembly 3102.
如图43所示，缝合线部分130A被接合之后，通过第一瓣叶132A的组织收回缝合线捕捉机构3106A和被接合的缝合线部分130A，进入远侧组件3102。可以使装置2100A稍稍收回，从而第一缝合线扣臂3104A可以运动至缩回位置，而不会夹紧第一瓣叶132A，如图44所示。然后，可以将缝合装置3100撤回至少足够远，从而允许第二缝合线扣臂3104B从装置伸出。As shown in Figure 43, after the suture portion 130A is engaged, the suture capture mechanism 3106A and the engaged suture portion 130A are withdrawn through the tissue of the first leaflet 132A and into the distal assembly 3102. The device 2100A can be retracted slightly so that the first suture clip arm 3104A can move to a retracted position without clamping the first leaflet 132A, as shown in Figure 44. The suturing device 3100 can then be withdrawn at least far enough to allow the second suture clip arm 3104B to extend from the device.
如图45所示，第二缝合线扣臂3104B可以从装置伸出，并且可以使装置前进，并且如果需要的话进行侧向运动，使得第二缝合线扣臂3104B延伸围绕第二瓣叶132B的尖端。在一些实施方案中，在收回第一臂3104A之前或同时，第二缝合线扣臂3104B可以伸出。45 , the second suture clip arm 3104B can be extended from the device and the device can be advanced and, if necessary, moved laterally so that the second suture clip arm 3104B extends around the tip of the second leaflet 132B. In some embodiments, the second suture clip arm 3104B can be extended before or simultaneously with the retraction of the first arm 3104A.
对于第一臂3104A，当第二缝合线扣臂3104B正确地围绕第二瓣叶132B时，可以使缝合线捕捉机构3106B从远侧组件3102前进，以穿透第二瓣叶132B并接合缝合线扣臂3104B所保持的缝合线部分130B，如图46所示。上文关于第一瓣叶132A应当注意到，在一些实施方案中，在缝合线捕捉机构3106B前进通过第二瓣叶132B而接合缝合线部分130B之前，可以使缝合线扣臂3104B运动至缩回位置，从而将第二瓣叶132B的一部分牢固地保持在臂3104B和远侧组件3102之间。在一些实施方案中，缝合线捕捉机构可以与利用第一臂104A的捕捉机构相同。在所示实施方案中，缝合线部分130A、B是分别的缝合线的部分，但是在一些实施方案中，缝合线部分130A、B可以是同一缝合线的部分。46 . As with the first arm 3104A, when the second suture clip arm 3104B is properly around the second leaflet 132B, the suture capture mechanism 3106B can be advanced from the distal assembly 3102 to penetrate the second leaflet 132B and engage the suture portion 130B held by the suture clip arm 3104B, as shown in FIG46 . It should be noted above with respect to the first leaflet 132A that, in some embodiments, before the suture capture mechanism 3106B is advanced through the second leaflet 132B to engage the suture portion 130B, the suture clip arm 3104B can be moved to a retracted position, thereby securely holding a portion of the second leaflet 132B between the arm 3104B and the distal assembly 3102. In some embodiments, the suture capture mechanism can be the same as the capture mechanism utilized with the first arm 104A. In the illustrated embodiment, the suture portions 130A, B are portions of separate sutures, but in some embodiments, the suture portions 130A, B can be portions of the same suture.
缝合线部分130B被接合之后，通过第二瓣叶132B的组织向远侧收回缝合线捕捉机构3106B和被接合的缝合线部分130B，进入远侧组件3102，如图47所示。在稍稍收回装置3100之后，可以闭合缝合线扣臂3104B，以避免夹紧第二瓣叶132B。当缝合线扣臂3104B闭合时，可以从患者心脏撤回缝合装置3100。After the suture portion 130B is engaged, the suture capture mechanism 3106B and the engaged suture portion 130B are withdrawn distally through the tissue of the second leaflet 132B and into the distal assembly 3102, as shown in Figure 47. After slightly retracting the device 3100, the suture clip arms 3104B can be closed to avoid clamping the second leaflet 132B. When the suture clip arms 3104B are closed, the suturing device 3100 can be withdrawn from the patient's heart.
在一些实施方案中，第一缝合线扣臂3104A和第二缝合线扣臂3104B可以在基本相同的时间都从装置伸出，并延伸围绕瓣叶132A，132B的相对尖端，如图48所示。在其他实施方案中，虽然扣臂可以同时伸出，但是一个在另一之前伸出。还如图所示，缝合线捕捉机构可以在基本相同的时间前进通过缝合线扣臂3104A、3104B。在其他实施方案中，虽然两个扣臂都可以延伸围绕瓣叶，但是缝合线捕捉机构可以使一个在另一个之前前进。In some embodiments, the first suture clip arm 3104A and the second suture clip arm 3104B can both extend from the device at substantially the same time and extend around the opposing tips of the leaflets 132A, 132B, as shown in FIG. 48. In other embodiments, although the clip arms can be extended simultaneously, one can be extended before the other. As also shown, the suture capture mechanism can be advanced through the suture clip arms 3104A, 3104B at substantially the same time. In other embodiments, although both clip arms can be extended around the leaflets, the suture capture mechanism can advance one before the other.
将缝合的瓣叶拉得更接近的方法Method for pulling the sutured leaflets closer together
如图49所示，在撤回个或多个缝合装置后，缝合线部分130A、130B会从瓣叶132A、132B向近侧伸出。本文中参照图49-59描述的将缝合的瓣叶拉得更接近的方法可以同样地适用于定向，例如图15，缝合装置从不同进入途径到达瓣的实施方案所反映的。另外，对于本文所述的所有方法，在系结或施加结之前或之后，可以将一个或多个填料附接于缝合线部分，并定位于结的远侧和/或近侧。图49显示了从瓣叶伸出的4股缝合线部分，如果上文所述的臂携带同一缝合线，则这可以包括单个缝合线，或者，如果上文所述的臂携带各自的合线，则这可以两个分别的缝合线(每个瓣叶缝合一条)。如果图49所示的4股是同一缝合线的部分，则可以从身体外部拉动缝合线的端部从而向缝合线施加张力并将瓣叶拉在一起。可以通过系出结、施加结或按照已知方法将缝合线部分连接在一起来将缝合线部分牢固地保持在一起。As shown in Figure 49, after withdrawing one or more suturing devices, suture portions 130A, 130B will extend proximally from leaflets 132A, 132B. The method of pulling the sutured leaflets closer together described herein with reference to Figures 49-59 can be equally applicable to orientation, such as that reflected in Figure 15, where the suture device reaches the leaflet from different entry routes. In addition, for all methods described herein, one or more fillers can be attached to the suture portion and positioned distally and/or proximally of the knot before or after tying or applying the knot. Figure 49 shows four strands of suture extending from the leaflets, which can include a single suture if the arms described above carry the same suture, or two separate sutures (one for each leaflet) if the arms described above carry their own sutures. If the four strands shown in Figure 49 are parts of the same suture, the ends of the suture can be pulled from outside the body to apply tension to the suture and pull the leaflets together. The suture portions may be securely held together by tying a knot, applying a knot, or connecting the suture portions together according to known methods.
在一些实施方案中，例如，当两个单独的缝合线被缝合至瓣叶132A和132B时，通过按照任何已知方法系出结134或通过施加结134，可以将单独的缝合线的两个端部牢固地保持在一起，如图50所示。可以在身体外部或在身体内部将缝合线部分130A、B牢固地保持在一起。可以修整缝合线的任何多余的部分。在一些实施方案中，可以拉动缝合线部分130A、B的自由端从而将第一瓣叶132A和第二瓣叶132B朝向彼此拉近，结或连接部分位于瓣叶之间，如图51所示。然后，可以向缝合线130A、B系出第二结或施加第二结以限制瓣叶132A、B相对于彼此的运动。In some embodiments, for example, when two separate sutures are sutured to leaflets 132A and 132B, the two ends of the separate sutures can be securely held together by tying a knot 134 or applying a knot 134 according to any known method, as shown in FIG50 . The suture portions 130A, B can be securely held together outside the body or inside the body. Any excess portion of the suture can be trimmed. In some embodiments, the free ends of the suture portions 130A, B can be pulled to draw the first leaflet 132A and the second leaflet 132B toward each other, with the knot or connecting portion located between the leaflets, as shown in FIG51 . A second knot can then be tied or applied to the sutures 130A, B to restrict movement of the leaflets 132A, B relative to each other.
在一些实施方案中，在如图51所示施加和定位结134后，可以首先仅拉动其中一个自由端，使结通过一个瓣叶并离开身体，如图52所示。这使得单个缝合线通过瓣叶。然后，可以拉动单个缝合线的两个部分，将第一瓣叶和第二瓣叶朝向彼此拉近，并且可以向两个部分系出第二结或施加第二结。In some embodiments, after applying and positioning the knot 134 as shown in Figure 51, one of the free ends can first be pulled only to pass the knot through one leaflet and out of the body, as shown in Figure 52. This allows a single suture to pass through the leaflet. The two portions of the single suture can then be pulled to draw the first and second leaflets toward each other, and a second knot can be tied or applied to the two portions.
在一些实施方案中，当两个单独的缝合线和4个缝合线部分从瓣叶伸出时，按照本文讨论的任何方法可以将所有4个部分牢固地保持在一起，如图53所示，而不用首先将缝合线部分的两个端部牢固地保持在一起。In some embodiments, when two separate sutures and four suture portions extend from the leaflet, all four portions can be securely held together according to any of the methods discussed herein, as shown in Figure 53, without first securely holding the two ends of the suture portions together.
在一些实施方案中，当单个缝合线通过瓣叶或一对缝合线通过瓣叶(例如图51和52所示)，可以将缝合线的一端与第二缝合线牢固地保持在一起，通过拉动第一缝合线可以将第二缝合线拉过瓣叶，并且可以向第二缝合线系出结或施加结。在该实施方案中，缝合装置所放置的第一缝合线可以用于引导第二缝合线或另一块材料越过瓣叶。在一些实施方案中，第二缝合线或另一块材料比第一缝合线更粗或强度更高。在一些实施方案中，第二块材料具有对接合组织更大的表面积，这可以有利地减小组织的切口。In some embodiments, when a single suture is passed through the leaflet or a pair of sutures are passed through the leaflet (e.g., as shown in Figures 51 and 52), one end of the suture can be firmly held together with a second suture, the second suture can be pulled through the leaflet by pulling the first suture, and a knot can be tied or applied to the second suture. In this embodiment, the first suture placed by the suturing device can be used to guide the second suture or another piece of material across the leaflet. In some embodiments, the second suture or another piece of material is thicker or stronger than the first suture. In some embodiments, the second piece of material has a larger surface area for engaging the tissue, which can advantageously reduce the incision of the tissue.
为了实现将第二缝合线或另外的材料块置于第一缝合线的位置，第二缝合线或其他材料块可以附接至已经放置的缝合线的一端或第一部分。通过利用任何已知方式形成结或通过其他方式(例如，通过将材料粘结在一起)进行连接可以使第一缝合线附接至第二缝合线或其他材料块。To facilitate placing a second suture or additional piece of material in place of the first suture, the second suture or other piece of material can be attached to one end or first portion of the already placed suture. The first suture can be attached to the second suture or other piece of material by forming a knot using any known means or by connecting by other means (e.g., by gluing the materials together).
然后，可以拉动第一缝合线的另一端或第二部分远离瓣叶。这使得较粗的缝合线被拉过组织并越过瓣叶到达第一缝合线所在的相同位置。较粗的缝合线被拉动越过瓣叶之后，在一个实施方案中，第二缝合线或材料块的端部会位于体外。The other end or second portion of the first suture can then be pulled away from the leaflets. This allows the thicker suture to be pulled through the tissue and over the leaflets to the same location where the first suture was located. After the thicker suture has been pulled over the leaflets, in one embodiment, the end of the second suture or piece of material is located outside the body.
第二缝合线或其他材料块可以脱离最初的缝合线，并且如果最初的缝合线还未从患者体内取出，可以将其取出。在第二缝合线或其他材料块的端部从开口伸出并位于患者体外的情况下，通过按照任何已知方法系出结或通过施加结(例如描述于2007年1月11日公开的美国专利公开2007/0010829A1，通过引用的方式将上述文献整体并入本文并作为说明书的一部分)可以将该缝合线或材料牢固地保持在一起。The second suture or other piece of material can be detached from the initial suture and, if the initial suture has not already been removed from the patient, can be removed. With the ends of the second suture or other piece of material extending from the opening and outside the patient's body, the suture or material can be securely held together by tying a knot according to any known method or by applying a knot (e.g., as described in U.S. Patent Publication No. 2007/0010829A1, published January 11, 2007, which is incorporated herein by reference in its entirety and made a part of this specification).
在一些实施方案中，当使用缝合线或其他材料来将瓣叶拉得更近并制造或施加结时，缝合线或其他材料可以使瓣叶132A，132B的部分保持彼此接触。在其他实施方案中，缝合线或其他材料仅使瓣叶132A、132B彼此比之前更为接近。In some embodiments, the suture or other material can hold portions of leaflets 132A, 132B in contact with each other while the suture or other material is used to draw the leaflets closer together and a knot is made or applied. In other embodiments, the suture or other material simply brings leaflets 132A, 132B closer together than before.
当使用如参照图38A-48所讨论的具有两个臂3104和两个缝合线捕捉机构3106的缝合装置时，装置3100可以被配置为能使单个缝合线130同时或依次通过第一瓣叶132A和第二瓣叶132B。在某些这类实施方案中，可以拉动缝合线部分130从而将第一瓣叶132A和第二瓣叶132B彼此拉近，而不用事先向缝合线130施加结。因此，可以向缝合线130施加单个结134而使瓣叶132A、132B保持彼此靠近。When using a suturing device having two arms 3104 and two suture capturing mechanisms 3106 as discussed with reference to Figures 38A-48, the device 3100 can be configured to pass a single suture 130 through the first leaflet 132A and the second leaflet 132B simultaneously or sequentially. In certain such embodiments, the suture portion 130 can be pulled to draw the first leaflet 132A and the second leaflet 132B toward each other without first applying a knot to the suture 130. Thus, a single knot 134 can be applied to the suture 130 to hold the leaflets 132A, 132B in close proximity.
可以使缝合线130通过瓣叶132位于医师所选定的位置来处理某个瓣的问题。例如，在一些实施方案中，可以使缝合线130通过瓣叶132到达位于或邻近瓣叶132的中央区的位置，如图54所示。在图55显示的实施方案中，3个缝合线130已通过瓣叶132，处于瓣叶的中央区。在一些实施方案中，缝合线130可以通过瓣叶132的部分，处于邻近瓣的外周的位置，如图56所示。在一些实施方案中，可以将缝合线130施加于两个瓣叶132之间的多个位置，如图57所示。在一些实施方案中，可以将缝合线130施加于多于两个瓣叶132之间的多个位置，如图58中参照三尖瓣所示。Sutures 130 can be passed through leaflets 132 to a position selected by the physician to address a problem with a particular valve. For example, in some embodiments, sutures 130 can be passed through leaflets 132 to a position at or adjacent to the central region of leaflets 132, as shown in FIG54. In the embodiment shown in FIG55, three sutures 130 have been passed through leaflets 132 and are in the central region of the leaflets. In some embodiments, sutures 130 can be passed through portions of leaflets 132 to a position adjacent to the periphery of the leaflet, as shown in FIG56. In some embodiments, sutures 130 can be applied to multiple locations between two leaflets 132, as shown in FIG57. In some embodiments, sutures 130 can be applied to multiple locations between more than two leaflets 132, as shown in FIG58 with reference to the tricuspid valve.
图59和60示出使缝合线通过瓣叶的其他方式。在一些实施方案中，利用图17-18和28-29所示的装置，可以将缝合线置于图59或60所示的位置。可以通过相同或不同的进入途径导入装置。例如，可以通过血管将一个装置导入心脏，而通过经心尖的方式导入另一装置。在一些实施方案中，可以通过图19-22所示的第一装置1100使第一缝合线通过第一瓣叶，并且可以通过图30-33所示的第二装置2100使第二缝合线通过第二瓣叶。在一些实施方案中，可以在放置第一缝合线之前放置第二缝合线。在涉及放置多个缝合线的实施方案中，可以用单个结或多个结连接多个缝合线。关于如图59和60所示放置缝合线的装置和方法的更多信息提供于2008年10月30日公开的美国专利申请公布2008/0269786，并且具体而言，提供于参照图10I-L、27-28B、36-39A-K描述的实施方案。Figures 59 and 60 illustrate alternative methods for passing sutures through the leaflets. In some embodiments, the sutures can be placed in the positions shown in Figures 59 or 60 using the devices shown in Figures 17-18 and 28-29. The devices can be introduced through the same or different access routes. For example, one device can be introduced into the heart transvascularly, while the other device can be introduced transapically. In some embodiments, a first suture can be passed through the first leaflet using a first device 1100 shown in Figures 19-22, and a second suture can be passed through the second leaflet using a second device 2100 shown in Figures 30-33. In some embodiments, the second suture can be placed before the first suture. In embodiments involving the placement of multiple sutures, the multiple sutures can be connected using a single knot or multiple knots. More information regarding the devices and methods for placing sutures as shown in Figures 59 and 60 is provided in U.S. Patent Application Publication No. 2008/0269786, published on October 30, 2008, and more specifically, in the embodiments described with reference to Figures 10I-L, 27-28B, and 36-39A-K.
用于瓣修复之外的技术的装置和方法Devices and methods for techniques other than valve repair
本文描述和参照的装置和方法可以用于实施瓣修复之外的其他技术。例如，上文所述的装置和方法可以用于向一个或多个腱索136和心肌138施加缝合线，如图61所示，从而恢复已被拉长的腱索的张力。在一些实施方案中，所施加的缝合线可作为引导缝合线以通过腱索递送第二缝合线或其他材料(例如人工腱索)，如上文所述。上文所述的装置和方法可以用于将补丁缝合至瓣叶中天然的或手术制造的开口。上文所述的装置和方法可以用于在功能失常瓣的外部附加环。上文所述的装置和方法可以用于将修补物缝合至心脏。The devices and methods described and referenced herein can be used to implement other techniques besides valve repair. For example, the devices and methods described above can be used to apply sutures to one or more chordae tendineae 136 and myocardium 138, as shown in Figure 61, to restore tension in the chordae tendineae that have been stretched. In some embodiments, the applied sutures can serve as guide sutures to deliver a second suture or other material (e.g., artificial chordae tendineae) through the chordae tendineae, as described above. The devices and methods described above can be used to suture a patch to a natural or surgically created opening in a valve leaflet. The devices and methods described above can be used to attach a ring to the outside of a malfunctioning valve. The devices and methods described above can be used to suture a patch to the heart.
其他缝合装置(例如缝合瓣的基部)的实施方案Other embodiments of suturing devices (e.g., suturing the base of a flap)
图62是可以用于缝合解剖学瓣(例如心脏瓣膜)的缝合装置4100的远端4102的示例性实施方案的示意性立体图。缝合装置4100可以包括两个缝合线捕捉机构4106和邻近于长形体4142的远端4102的单个臂4104。臂被配置为能在缩回位置和伸出位置之间运动。在一些实施方案中，通过绕枢转地连接于长形体4142的臂的端部旋转，可以使臂在缩回位置和伸出位置之间运动。在其他实施方案中，可以使臂沿着长度方向前进离开长形体4142的开口，如2005年6月28授权的美国专利6,911,034中所述，通过引用的方式将上述文献整体并入本文并作为说明书的一部分。Figure 62 is a schematic perspective view of an exemplary embodiment of the distal end 4102 of a suturing device 4100 that can be used to sew an anatomical valve (e.g., a heart valve). The suturing device 4100 can include two suture capture mechanisms 4106 and a single arm 4104 adjacent to the distal end 4102 of an elongated body 4142. The arm is configured to move between a retracted position and an extended position. In some embodiments, the arm can be moved between a retracted position and an extended position by rotating around the end of the arm pivotally connected to the elongated body 4142. In other embodiments, the arm can be advanced along the length direction to leave the opening of the elongated body 4142, as described in U.S. Patent No. 6,911,034, which was authorized on June 28, 2005, and is incorporated herein by reference in its entirety as a part of the specification.
在图62的实施方案中，单个臂4104包括两个缝合线扣或座架4126，其邻近于臂4104的自由端。在一些实施方案中，臂4104可以包括多于两个缝合线扣4126。缝合线扣4126可以位于或邻近臂4104的自由端。该实施方案的臂4104足够长，从而能将缝合线扣4126置于位于或邻近心脏瓣膜(例如二尖瓣)的基部的位置。图62所示的臂4104大体上正交于长形体4142的纵轴伸出。62, a single arm 4104 includes two suture clasps or mounts 4126 adjacent to the free end of the arm 4104. In some embodiments, the arm 4104 can include more than two suture clasps 4126. The suture clasps 4126 can be located at or adjacent to the free end of the arm 4104. The arm 4104 of this embodiment is sufficiently long to position the suture clasps 4126 at or adjacent to the base of a heart valve (e.g., the mitral valve). The arm 4104 shown in FIG62 extends generally orthogonally to the longitudinal axis of the elongated body 4142.
臂4104的缝合线扣4126彼此隔开一定距离。缝合线扣之间的距离在不同实施方案中可以不同。分开的幅度大体上对应于组织中缝合线放置位置之间分开的幅度。缝合线扣之间分开的幅度可以根据所希望的用途而变化。The suture clasps 4126 of arm 4104 are spaced apart from one another by a distance. The distance between the suture clasps can vary in different embodiments. The separation generally corresponds to the separation between suture placement locations in tissue. The separation between the suture clasps can vary depending on the desired application.
在图62的示例性实施方案中，两个缝合线捕捉机构4106显示为针。在一些实施方案中，可以同时操作针，在其他实施方案中，可以依次操作针。正如结合之前的实施方案所描述的，可以展开和收回缝合线捕捉机构，从而收回由臂4104可释放地保持的缝合线部分130(参见图65-68)。尽管图62所示的实施方案包括两个针，但是在一些实施方案中，该缝合装置可以包括多于两个针。臂4104通常被配置为具有相同数量的缝合线座架和缝合线捕捉机构，每个缝合线座架可释放地携带缝合线部分。In the exemplary embodiment of Figure 62, two suture capture mechanisms 4106 are shown as needles. In some embodiments, the needles can be operated simultaneously, and in other embodiments, the needles can be operated sequentially. As described in conjunction with the previous embodiments, the suture capture mechanism can be deployed and retracted, thereby retracting the suture portion 130 (see Figures 65-68) releasably held by the arm 4104. Although the embodiment shown in Figure 62 includes two needles, in some embodiments, the suturing device can include more than two needles. Arm 4104 is generally configured to have the same number of suture holders and suture capture mechanisms, and each suture holder releasably carries the suture portion.
图62的示例性实施方案还包括保护构件4107(本文中也称为“针臂”)。保护构件4107被配置为能在针至少一部分展开的过程中限制缝合线捕捉机构的远端和周围组织之间的接触。通常，当缝合线捕捉机构从其缩回位置运动至瓣中缝合线部分要通过的位置时，保护构件保护缝合装置4100周围的组织免受缝合线捕捉机构4106的损伤。The exemplary embodiment of FIG62 further includes a protective member 4107 (also referred to herein as a "needle arm"). The protective member 4107 is configured to limit contact between the distal end of the suture capture mechanism and surrounding tissue during at least a portion of the needle being deployed. Typically, the protective member protects the tissue surrounding the suturing device 4100 from damage by the suture capture mechanism 4106 as the suture capture mechanism moves from its retracted position to a position in the valve where the suture portion is to pass.
如图62所示，在包括多个缝合线捕捉机构的实施方案中，缝合装置可以对应于每个缝合线捕捉机构而具有单独的保护构件。在其他实施方案中，缝合装置可以具有单个保护构件，其被配置为能同时保护周围组织免于两个或更多个缝合线捕捉机构的损伤。As shown in Figure 62, in the embodiment comprising multiple suture capture mechanisms, suturing device can have a separate protective member corresponding to each suture capture mechanism. In other embodiments, suturing device can have a single protective member, which is configured to protect surrounding tissue from the damage of two or more suture capture mechanisms simultaneously.
在一些实施方案中(例如图62的实施方案)，保护构件可以具有大体上套管样的构型，从而大体上包绕缝合线捕捉机构4106。在一些实施方案中，保护构件可以完全包绕缝合线捕捉机构的周边。在其他实施方案中，保护构件可以仅部分地包绕缝合线捕捉机构的周边。例如，无论是包绕一个还是多个缝合线捕捉机构，在一些实施方案中，保护构件可以具有大体上U形截面，并且当保护构件伸出时，保护构件的开口的方向面对长形体。在一些实施方案中，保护构件可以完全包绕单个腔中的多个针。In some embodiments (e.g., the embodiment of FIG. 62 ), the protective member can have a generally cannula-like configuration, thereby generally surrounding the suture capture mechanism 4106. In some embodiments, the protective member can completely surround the periphery of the suture capture mechanism. In other embodiments, the protective member can only partially surround the periphery of the suture capture mechanism. For example, whether surrounding one or more suture capture mechanisms, in some embodiments, the protective member can have a generally U-shaped cross-section, and when the protective member is extended, the direction of the opening of the protective member faces the elongated body. In some embodiments, the protective member can completely surround multiple needles in a single lumen.
优选地，保护构件延伸跨越缝合线捕捉机构的远端，延伸超过缝合线捕捉机构的远端或两者。Preferably, the protective member extends across the distal end of the suture capture mechanism, extends beyond the distal end of the suture capture mechanism, or both.
图62的示例性实施方案的保护构件4107可以在缩回位置和伸出位置之间运动。如图63所示，保护构件4107可以在对应的缝合线捕捉机构4106伸出之前从长形体4142伸出，使得当缝合线捕捉机构朝向待缝合的瓣的位置运动时，缝合线捕捉机构的远端不会暴露于周围组织。The protective member 4107 of the exemplary embodiment of Figure 62 can be moved between a retracted position and an extended position. As shown in Figure 63, the protective member 4107 can be extended from the elongated body 4142 before the corresponding suture capture mechanism 4106 is extended, so that when the suture capture mechanism is moved toward the position of the flap to be sutured, the distal end of the suture capture mechanism is not exposed to the surrounding tissue.
在一些实施方案中，当保护构件4107已前进到达缝合线放置位置时(例如如图63所示)，缝合线捕捉机构4106可以朝向缝合线放置位置和臂4104前进。在缝合线捕捉机构已从臂收回缝合线部分(如结合前文的实施方案所讨论)之后，可以将缝合线捕捉机构4106和保护构件4107以及缝合线部分130收回入长形体4142。在一些实施方案中，在针从其缩回位置运动之前，保护构件可以大体上位于待缝合的位置。在其他实施方案中，针可以朝向其展开位置运动，同时保护构件是伸出的。例如，当保护构件和针都前进时，保护构件的远端的位置可以超过对应的针的远端。在这类实例中，当保护构件的远端大体上位于待缝合的位置时，可以使针的远端前进超过保护构件的远端，从而穿透瓣的组织。In some embodiments, when the protective member 4107 has advanced to the suture placement position (e.g., as shown in FIG. 63 ), the suture capture mechanism 4106 can advance toward the suture placement position and the arm 4104. After the suture capture mechanism has retracted the suture portion from the arm (as discussed in conjunction with the preceding embodiments), the suture capture mechanism 4106 and the protective member 4107 and the suture portion 130 can be retracted into the elongated body 4142. In some embodiments, before the needle moves from its retracted position, the protective member can be substantially located at the position to be sutured. In other embodiments, the needle can move toward its deployed position while the protective member is extended. For example, when both the protective member and the needle advance, the position of the distal end of the protective member can exceed the distal end of the corresponding needle. In such instances, when the distal end of the protective member is substantially located at the position to be sutured, the distal end of the needle can be advanced beyond the distal end of the protective member, thereby penetrating the tissue of the flap.
当多个缝合线捕捉机构4106同时朝向臂4104前进时，保护构件4107也可以同时前进。或者，尽管缝合线捕捉机构同时前进，保护构件4107可以依次前进。在一些实施方案中，保护构件4107可以同时前进，而缝合线捕捉机构依次前进。每个臂多个缝合线捕捉机构的应用以及保护构件的应用可以被合并入本文所述的任何装置，包括前文所述的缘至缘修复装置。When multiple suture capturing mechanisms 4106 are simultaneously advanced toward arm 4104, protective member 4107 may also be advanced simultaneously. Alternatively, while the suture capturing mechanisms are advanced simultaneously, protective members 4107 may be advanced sequentially. In some embodiments, protective members 4107 may be advanced simultaneously while the suture capturing mechanisms are advanced sequentially. The use of multiple suture capturing mechanisms per arm and the use of protective members may be incorporated into any of the devices described herein, including the edge-to-edge repair devices described above.
图65-70示例性地示出按照一个实施方案的图62-64的缝合装置4100的使用。图65-70所示的瓣可以是二尖瓣8，缝合装置可以经心尖开口或利用上文讨论的任何进入途径(利用或不利用导丝)被插入瓣。虽然结合图65-70的二尖瓣进行描述，但是该描述也可以应用于二尖瓣以外的瓣。Figures 65-70 illustrate, by way of example, the use of the suturing device 4100 of Figures 62-64 according to one embodiment. The valve shown in Figures 65-70 can be a mitral valve 8, and the suturing device can be inserted into the valve via the apical opening or using any of the access routes discussed above (with or without a guidewire). Although described in conjunction with the mitral valve of Figures 65-70, the description can also be applied to valves other than the mitral valve.
如图65所示，缝合装置4100的远侧组件4102前进进入通过二尖瓣8的通道。远侧组件4102前进通过通道的距离足够远，从而能允许臂4104张开，而不会损伤周围组织。当臂4104伸出时，将缝合装置通过通道收回，使得臂4104的自由端邻近瓣的基部，如图66所示。然后，保护构件4107前进使保护构件4107的远端位于或邻近瓣的基部。在一些实施方案中，瓣的瓣叶132可以置于臂4104和保护构件之间，例如，如图66所示。当保护构件已前进时，缝合线捕捉机构4106前进通过瓣的组织从而接合臂4104，如图67所示。As shown in Figure 65, the distal assembly 4102 of the suturing device 4100 is advanced into the passage through the mitral valve 8. The distance that the distal assembly 4102 advances through the passage is far enough to allow the arms 4104 to open without damaging the surrounding tissue. When the arms 4104 are extended, the suturing device is retracted through the passage so that the free ends of the arms 4104 are adjacent to the base of the valve, as shown in Figure 66. The protective member 4107 is then advanced so that the distal end of the protective member 4107 is located at or adjacent to the base of the valve. In some embodiments, the leaflets 132 of the valve can be placed between the arms 4104 and the protective member, for example, as shown in Figure 66. When the protective member has advanced, the suture capture mechanism 4106 advances through the tissue of the valve to engage the arms 4104, as shown in Figure 67.
图68是沿线68-68得到的图67的臂4104、缝合线捕捉机构4106以及瓣的示意性部分截面图。虽然图68显示了同时通过组织的两个针，然是这样的设置不会发生在一些实施方案中，例如当第一针在第二针展开之前展开和收回时。Figure 68 is a schematic partial cross-sectional view of the arm 4104, suture capture mechanism 4106, and flap of Figure 67 taken along line 68-68. Although Figure 68 shows both needles passing through tissue simultaneously, such an arrangement does not occur in some embodiments, such as when the first needle is deployed and retracted before the second needle is deployed.
缝合线捕捉机构4106被通过组织收回，缝合线部分130进入长形体4142。在收回缝合线捕捉机构4106之前、之后或同时，可以将保护构件4107收回入长形体4142。图69显示了通过瓣的缝合线部分130，缝合装置100被从瓣撤回。Suture capture mechanism 4106 is withdrawn through the tissue and suture portion 130 enters elongated body 4142. Protective member 4107 may be withdrawn into elongated body 4142 before, after, or simultaneously with the withdrawal of suture capture mechanism 4106. Figure 69 shows suture portion 130 passed through a flap and suturing device 100 withdrawn from the flap.
缝合线部分130通过瓣的情况下，将缝合线部分拉紧，从而将缝合线穿透位置拉在一起。如图70所示，然后通过打结或上文所述的或通过引用的方式并入本文作为说明书一部分的专利中的其他方法将缝合线牢固地保持在一起。When the suture portion 130 passes through the flap, the suture portion is tightened, thereby pulling the suture penetration position together. As shown in Figure 70, the suture is then securely held together by tying a knot or other methods described above or incorporated by reference into the patents as a part of this specification.
在另一实施方案中，可以使用配置与图62-64的缝合装置相似的缝合装置5100，区别在于臂5104包括单个缝合线扣5126，而不是多个缝合线扣5126。如图71所示，当使用具有带有单个缝合线扣的臂5104A的装置时，缝合装置至少部分位于二尖瓣8中，如结合图65-67所说明和描述的。图71是沿线68-68得到的图67中的臂、针以及瓣的示意性部分截面图，该实施方案利用具有臂的缝合装置，臂包括单个缝合线座架。如图71所示，臂5104A已位于瓣的第一侧，缝合线捕捉机构5106A已从瓣的第二侧通过瓣的组织。然后，收回缝合线捕捉机构5106A，从而使缝合线部分130通过瓣，如图72所示。In another embodiment, a suturing device 5100 having a configuration similar to that of the suturing device of Figures 62-64 can be used, except that the arm 5104 includes a single suture buckle 5126, rather than multiple suture buckles 5126. As shown in Figure 71, when using a device having an arm 5104A with a single suture buckle, the suturing device is at least partially positioned within the mitral valve 8, as illustrated and described in conjunction with Figures 65-67. Figure 71 is a schematic partial cross-sectional view of the arm, needle, and valve of Figure 67 taken along line 68-68, an embodiment utilizing a suturing device having an arm that includes a single suture holder. As shown in Figure 71, the arm 5104A has been positioned on a first side of the valve, and the suture capture mechanism 5106A has been passed through the tissue of the valve from a second side of the valve. The suture capture mechanism 5106A is then retracted, allowing the suture portion 130 to pass through the valve, as shown in Figure 72.
然后，将第二臂5104B定位，从而将第二缝合线部分置于与图72所示的第一位置隔开的位置。在一些实施方案中，第二臂可以与第一臂5104A附接于同一长形体5142。在其他实施方案中，第二臂可以附接于与先前的装置具有相似或相同的配置的第二装置。如果使用第二装置，可以按照上文结合图65-67和71所述的步骤将其导入二尖瓣，并且随着将缝合线捕捉机构106通过瓣收回，使第二缝合线部分通过瓣。The second arm 5104B is then positioned to place the second suture portion in a position spaced apart from the first position shown in FIG. 72. In some embodiments, the second arm can be attached to the same elongated body 5142 as the first arm 5104A. In other embodiments, the second arm can be attached to a second device having a similar or identical configuration to the previous device. If a second device is used, it can be introduced into the mitral valve according to the steps described above in connection with FIGs. 65-67 and 71, and the second suture portion passed through the valve as the suture capture mechanism 106 is retracted through the valve.
图73显示了通过瓣8的组织的两个单独的缝合线部分。如图73所示，然后通过打结或例如上文所述的或通过引用的方式并入本文作为说明书一部分的专利中的其他方式将缝合线部分130牢固地保持在一起。然后，拉动缝合线部分130的第二端，从而将缝合线部分通过组织拉近，并将缝合线部分的固定的第一端置于邻近组织一侧的位置，如图74所示。将缝合线部分130拉紧以将缝合线穿透位置通过组织拉在一起并牢固地保持在一起，如图75所示。FIG73 shows two separate suture portions passed through the tissue of flap 8. As shown in FIG73, the suture portions 130 are then securely held together by tying a knot or other means such as those described above or in the patents incorporated herein by reference as a part of this specification. The second end of the suture portion 130 is then pulled, thereby drawing the suture portion through the tissue and placing the fixed first end of the suture portion in a position adjacent to one side of the tissue, as shown in FIG74. The suture portion 130 is tightened to draw the suture penetration sites together through the tissue and securely hold them together, as shown in FIG75.
图76是缝合装置的示例性实施方案的示意性立体图，该缝合装置包括两个缝合线捕捉机构6106和邻近于长形体6142的远端的单个臂6104。图76所示的缝合装置与图62的缝合装置相似，区别在于(1)图76的缝合装置的缝合线捕捉机构6106位于臂6104的远侧并被配置为能向近侧从缩回位置运动至展开位置，(2)图76的实施方案的臂6104向远侧并向外从长形体6142伸出，使得臂6104和长形体6142的纵轴之间的角少于90°以及(3)由前两个区别产生的、与图62的装置相比对图76的装置的其他改变，这是从前述实施方案能够理解到的。FIG76 is a schematic perspective view of an exemplary embodiment of a suturing device including two suture capture mechanisms 6106 and a single arm 6104 adjacent the distal end of an elongated body 6142. The suturing device shown in FIG76 is similar to the suturing device of FIG62 except that (1) the suture capture mechanisms 6106 of the suturing device of FIG76 are located distally of the arms 6104 and are configured to move proximally from a retracted position to a deployed position, (2) the arms 6104 of the embodiment of FIG76 extend distally and outwardly from the elongated body 6142 such that the angle between the arms 6104 and the longitudinal axis of the elongated body 6142 is less than 90°, and (3) other changes to the device of FIG76 compared to the device of FIG62 resulting from the first two differences will be appreciated from the foregoing embodiments.
图77-79示例性地示出按照一个实施方案的图76的缝合装置6100的使用。图77-79所示的瓣可以是二尖瓣8，并且可以经由通过下腔静脉和房间隔的进入途径(利用或不利用导丝)将缝合装置插入瓣。虽然结合图77-79的二尖瓣进行描述，但伴随的描述可以适用于二尖瓣之外的瓣。Figures 77-79 exemplarily illustrate the use of the suturing device 6100 of Figure 76 according to one embodiment. The valve shown in Figures 77-79 can be a mitral valve 8, and the suturing device can be inserted into the valve via an access route through the inferior vena cava and the atrial septum (with or without a guidewire). Although described in conjunction with the mitral valve of Figures 77-79, the accompanying description can be applicable to valves other than the mitral valve.
如图77所示，缝合装置6100的远侧组件6102前进到通过二尖瓣8的通道中。使臂6104从长形体6142伸出并使缝合装置前进通过通道，使得臂6104的自由端邻近瓣的基部，如图77所示。然后，使保护构件6107前进，将保护构件6107的远端置于位于或邻近瓣的基部的位置。在一些实施方案中，瓣的瓣叶132可以置于臂6104和保护构件之间，例如，如图78所示。一旦保护构件前进，缝合线捕捉机构6106前进通过瓣的组织而接合臂6104，如图79所示。As shown in Figure 77, the distal assembly 6102 of the suturing device 6100 is advanced into the passage through the mitral valve 8. The arm 6104 is extended from the elongated body 6142 and the suturing device is advanced through the passage so that the free end of the arm 6104 is adjacent to the base of the valve, as shown in Figure 77. The protective member 6107 is then advanced, and the distal end of the protective member 6107 is placed in a position at or adjacent to the base of the valve. In some embodiments, the leaflets 132 of the valve can be placed between the arm 6104 and the protective member, for example, as shown in Figure 78. Once the protective member is advanced, the suture capture mechanism 6106 is advanced through the tissue of the valve to engage the arm 6104, as shown in Figure 79.
然后，两个缝合线部分以与结合图68-70所说明和描述基本相同的方式通过瓣组织。在缝合装置的臂仅包括单个缝合线座架的实施方案中，缝合线部分可以以与结合图71-75所说明和描述基本相同的方式通过瓣组织。Then, the two suture portions are passed through the flap tissue in substantially the same manner as illustrated and described in conjunction with Figures 68-70. In embodiments where the arm of the suturing device comprises only a single suture holder, the suture portions can be passed through the flap tissue in substantially the same manner as illustrated and described in conjunction with Figures 71-75.
图80是缝合装置的示例性实施方案的示意性立体图，该缝合装置包括两个缝合线捕捉机构7106和邻近于长形体7142的远端的单个臂7104。图80所示的缝合装置与图76的缝合装置相似，区别在于图80的缝合装置的缝合线捕捉机构7106位于臂7104的近侧并被配置为能向远侧从缩回位置运动至展开位置，并且图80的缝合装置包括由臂和缝合线捕捉机构的设置产生的、与图76的装置相比的其他改变，这是从前述实施方案能够理解到的。Figure 80 is a schematic perspective view of an exemplary embodiment of a suturing device including two suture capture mechanisms 7106 and a single arm 7104 adjacent to the distal end of an elongated body 7142. The suturing device shown in Figure 80 is similar to the suturing device of Figure 76, except that the suture capture mechanism 7106 of the suturing device of Figure 80 is located proximal to the arm 7104 and is configured to be movable distally from a retracted position to an extended position, and the suturing device of Figure 80 includes other changes resulting from the arrangement of the arms and suture capture mechanism compared to the device of Figure 76, as will be understood from the aforementioned embodiments.
图81-83示例性地示出按照一个实施方案的图80的缝合装置7100的使用。图81-83所示的瓣可以是二尖瓣8，并且所述缝合装置可以经由通过下腔静脉和房间隔的进入通道被插入瓣，利用或不利用导丝。尽管是结合图81-83的二尖瓣进行描述的，但是伴随的描述可以适用于二尖瓣以外的瓣。Figures 81-83 exemplarily illustrate the use of the suturing device 7100 of Figure 80 according to one embodiment. The valve shown in Figures 81-83 can be a mitral valve 8, and the suturing device can be inserted into the valve via an access channel through the inferior vena cava and the atrial septum, with or without a guidewire. Although described in conjunction with the mitral valve of Figures 81-83, the accompanying description can be applied to valves other than the mitral valve.
如图81所示，缝合装置7100的远侧组件7102前进进入通过二尖瓣8的通道。远侧组件7102前进通过通道的距离足够远，从而能允许臂7104张开，而不会损伤周围组织。当臂7104伸出时，缝合装置通过通道被收回，使得臂7104的自由端邻近瓣的基部，如图82所示。然后，保护构件7107前进，从而使保护构件7107的远端位于或邻近瓣的基部。在一些实施方案中，瓣的瓣叶132的位置可以位于臂7104和保护构件之间，例如如图82所示。当保护构件前进时，缝合线捕捉机构7106前进通过瓣的组织而接合臂7104，如图83所示。As shown in Figure 81, the distal assembly 7102 of the suturing device 7100 advances into the passage through the mitral valve 8. The distance that the distal assembly 7102 advances through the passage is far enough to allow the arms 7104 to open without damaging the surrounding tissue. When the arms 7104 are extended, the suturing device is retracted through the passage so that the free ends of the arms 7104 are adjacent to the base of the valve, as shown in Figure 82. The protective member 7107 is then advanced so that the distal end of the protective member 7107 is located at or adjacent to the base of the valve. In some embodiments, the leaflets 132 of the valve can be located between the arms 7104 and the protective member, for example, as shown in Figure 82. As the protective member advances, the suture capture mechanism 7106 advances through the tissue of the valve to engage the arms 7104, as shown in Figure 83.
然后，以结合图68-70所说明和描述的基本相同的方式，使两个缝合线部分通过瓣的组织，区别在于臂和缝合线捕捉机构的位置已相对于瓣发生交换。在缝合装置的臂仅包括单个缝合线座架的实施方案中，可以以结合图71-75所说明和描述的基本相同的方式，使缝合线部分通过瓣组织，区别在于臂和缝合线捕捉机构的位置已相对于瓣发生交换。The two suture portions are then passed through the tissue of the flap in substantially the same manner as illustrated and described in conjunction with Figures 68-70, except that the positions of the arms and suture capture mechanisms have been swapped relative to the flap. In embodiments where the arms of the suturing device include only a single suture holder, the suture portions can be passed through the tissue of the flap in substantially the same manner as illustrated and described in conjunction with Figures 71-75, except that the positions of the arms and suture capture mechanisms have been swapped relative to the flap.
利用结合图65-75、77-79以及81-83所说明和描述的方法，可以使缝合线通过邻近瓣的基部的多个位置。例如，图84和85示例性地示出缝合线可被置于瓣中的位置148。如图84所示，可以使缝合线在位置148通过瓣组织，位置148大体上位于邻近瓣叶132之间。可选地或另外地，可以使缝合线可以通过位置148，位置148位于或邻近瓣叶132的基部、大致位于瓣叶132的中部，如图85所示。结合图65-75、77-79以及81-83所说明和描述的装置和方法可以用于实施其他操作，例如在功能失常的瓣的外部的周围附接环，以及将修补装置附接于组织。上文所述的保护构件或针臂还可以用于上文所述的用于缝合瓣(例如二尖瓣的缘至缘缝合)的缝合装置的实施方案中。在这些实施方案中，针臂可以展开至能夹紧缝合线扣臂和针臂之间的瓣叶的位置。然后，缝合线捕捉机构或针可以前进，从针臂离开，通过瓣的组织叶以及与缝合线扣臂所保持的缝合线端部接合。Utilizing the methods illustrated and described in conjunction with Figures 65-75, 77-79, and 81-83, a suture can be passed through a plurality of locations adjacent to the base of a valve. For example, Figures 84 and 85 exemplarily illustrate a location 148 at which a suture can be placed in the valve. As shown in Figure 84, a suture can be passed through the valve tissue at location 148, which is generally located between adjacent leaflets 132. Alternatively or in addition, a suture can be passed through location 148, which is located at or adjacent to the base of leaflets 132, generally located in the middle of leaflets 132, as shown in Figure 85. The devices and methods illustrated and described in conjunction with Figures 65-75, 77-79, and 81-83 can be used to perform other operations, such as attaching a ring around the outside of a malfunctioning valve, and attaching a repair device to tissue. The protective member or needle arm described above can also be used in the embodiments of the suturing device described above for suturing a valve (e.g., edge-to-edge suturing of a mitral valve). In these embodiments, the needle arm can be extended to a position that can clamp the valve leaflet between the suture clip arm and the needle arm.Then, the suture capture mechanism or needle can be advanced, away from the needle arm, through the tissue leaflet of the valve and engage the suture end held by the suture clip arm.
尽管已经描述了使用具有带单个缝合线座架的臂的缝合装置和使用在单个臂中带多个缝合线座架的缝合装置缝合瓣组织的方法，但是其他实施方案可以使用包括具有多于两个缝合线扣和对应数量的针的臂的缝合装置，所述缝合线扣和针被配置为能从每个缝合线扣收回缝合线部分。Although methods of suturing flap tissue using a suturing device having an arm with a single suture holder and using a suturing device with multiple suture holders in a single arm have been described, other embodiments may use a suturing device including an arm with more than two suture buckles and a corresponding number of needles, wherein the suture buckles and needles are configured to be able to retract a suture portion from each suture buckle.
图86示例性地显示了人类心脏的左心室中的腱索。将缝合装置的臂置于与腱索相对的瓣的一侧(例如，心房侧)可以便于保护腱索免受损伤并通过避免臂与腱索缠绕而便于操作。例如上文或下文所述的保护构件(本文中也称为“针臂”)能有助于避免缝合线捕捉机构(例如，与腱索位于瓣的同一侧(例如，心室侧)的针)对腱索造成损伤。FIG86 exemplarily shows the chordae tendineae in the left ventricle of a human heart. Placing the arms of the suturing device on the side of the valve opposite the chordae tendineae (e.g., the atrial side) can facilitate protection of the chordae tendineae from damage and facilitate manipulation by preventing the arms from becoming entangled with the chordae tendineae. For example, a protective member (also referred to herein as a "needle arm") as described above or below can help prevent damage to the chordae tendineae by a suture capture mechanism (e.g., a needle located on the same side of the valve as the chordae tendineae (e.g., the ventricular side)).
具有多个臂的缝合装置和方法，例如用于缝合瓣的基部Suturing device and method with multiple arms, such as for suturing the base of a flap
图87和88示出缝合装置8100的示例性实施方案，缝合装置8100具有长形体并在长形体的远端包括多个缝合臂8104，每个臂具有两个缝合线扣8126。这种实施方案可以便于实施瓣膜成形术。所示的实施方案包括6个臂8104，每个臂具有两个缝合线座架8126，臂垂直于长形体的纵轴延伸。每个所示的缝合线座架可释放地携带缝合线部分，用于被缝合线捕捉机构取回。其他实施方案可以包括少于6个臂或多于6个臂。在一些实施方案中，装置可以包括单个臂。在一些实施方案中，臂可以绕长形体转动。Figures 87 and 88 show an exemplary embodiment of a suturing device 8100 having an elongated body and including a plurality of suturing arms 8104 at the distal end of the elongated body, each arm having two suture clasps 8126. This embodiment can facilitate the performance of valvuloplasty. The illustrated embodiment includes six arms 8104, each arm having two suture holders 8126, the arms extending perpendicular to the longitudinal axis of the elongated body. Each of the illustrated suture holders releasably carries a suture portion for retrieval by a suture capture mechanism. Other embodiments can include fewer than six arms or more than six arms. In some embodiments, the device can include a single arm. In some embodiments, the arm can rotate about the elongated body.
图88所示的臂的尺寸被设定为当装置的长形体被置于瓣的开口中时，能允许缝合线座架位于或邻近瓣的基部。在一些实施方案中，设定臂的尺寸和配置，使得当装置在瓣中并且臂被展开时，所有臂上的每个缝合线座架位于或邻近瓣的基部。例如，每个臂可以具有约1.5cm的长度，缝合线座架可以位于或邻近臂的最外点。在其他实施方案中，臂可以长于或短于1.5cm。各个实施方案可以具有长度不同的臂，从而适应待缝合的具体瓣和目标患者的解剖学结构的尺寸。The arms shown in Figure 88 are sized to allow the suture holder to be located at or adjacent to the base of the flap when the elongated body of the device is placed in the opening of the flap. In some embodiments, the arms are sized and configured so that when the device is in the flap and the arms are deployed, each suture holder on all arms is located at or adjacent to the base of the flap. For example, each arm can have a length of approximately 1.5 cm, and the suture holder can be located at or adjacent to the outermost point of the arm. In other embodiments, the arms can be longer or shorter than 1.5 cm. Various embodiments can have arms of different lengths to accommodate the size of the specific flap to be sutured and the anatomical structure of the target patient.
图87和88的实施方案包括12个缝合线捕捉机构(未示出)，每个缝合线捕捉机构对应于装置的每个缝合线座架。缝合线捕捉机构可以为上文所述的以及通过引用并入本文(作为说明书的一部分)的专利中描述的类型，例如，针。这些针可以在位于臂近侧的长形体的一部分中的携带器中，围绕长形体的周边排列，在位置上对应于臂的端部上的缝合线座架。缝合线捕捉机构可以由使用者促动，从而沿近侧至远侧方向运动，向外远离长形体伸出，从而刺过组织并结合缝合线座架。向近侧收回缝合线捕捉机构能携带缝合线远离臂，通过组织并返回臂中。缝合线捕捉机构可以彼此独立地操作，或者在一些实施方案中，可以成组操作。例如，在一些实施方案中，可以同时操作两个或更多个针。还考虑到了其他实施方案，其中在装置上提供的针少于缝合线座架，但是可以根据需要装载和再装载另外的针，来刺过组织和收回缝合线。在某些实施方案中，针可以容纳于携带器中，携带器能绕长形体的周边转动，从而将针置于相对于缝合线座架希望的位置。The embodiment of Figures 87 and 88 includes 12 suture capture mechanisms (not shown), each suture capture mechanism corresponding to each suture holder of the device. The suture capture mechanism can be of the type described above and in the patents incorporated herein by reference (as part of the specification), for example, a needle. These needles can be in a carrier in a portion of the elongated body located proximal to the arm, arranged around the periphery of the elongated body, corresponding in position to the suture holder on the end of the arm. The suture capture mechanism can be actuated by the user so as to move in a proximal to distal direction, extending outward away from the elongated body, thereby piercing the tissue and combining with the suture holder. The suture capture mechanism can be retracted proximally and can carry the suture away from the arm, through the tissue and back into the arm. The suture capture mechanisms can operate independently of each other, or in some embodiments, can operate in groups. For example, in some embodiments, two or more needles can be operated simultaneously. Other embodiments are also contemplated, in which the needles provided on the device are less than the suture holder, but additional needles can be loaded and reloaded as needed to pierce the tissue and retract the suture. In certain embodiments, the needle can be housed in a carrier that can be rotated about the periphery of the elongated body to position the needle at a desired position relative to the suture holder.
图87和88所示的缝合装置包括保护构件8107，其被配置为能保护周围组织(例如腱索)免受缝合线捕捉机构运动的影响。图87和88所示的保护构件是长形体，其包括延伸通过保护构件的一段的两个腔8150，但是在一些实施方案中，保护构件可以包括其他数量的腔，如上文所讨论。The suturing device shown in Figures 87 and 88 includes a protective member 8107 that is configured to protect surrounding tissue (e.g., chordae tendineae) from the movement of the suture capture mechanism. The protective member shown in Figures 87 and 88 is an elongated body that includes two lumens 8150 extending through a section of the protective member, but in some embodiments, the protective member can include other numbers of lumens, as discussed above.
该实施方案的保护构件8107被配置为能在平行于长形体纵轴的缩回位置和向外伸出的展开位置之间运动。保护构件还被配置为当保护构件处于缩回位置、展开位置以及缩回位置和展开位置之间的位置时，能绕缝合装置的纵轴转动，从而使保护构件指向所需的臂。在一些实施方案中，保护构件被配置为仅当保护构件处于选定的一个或多个位置时(例如完全缩回位置、完全展开位置或完全缩回和完全展开位置之间的选定位置)，能绕缝合装置转动。The protective member 8107 of this embodiment is configured to move between a retracted position parallel to the longitudinal axis of the elongated body and an outwardly extending extended position. The protective member is further configured to rotate about the longitudinal axis of the suturing device when the protective member is in the retracted position, the extended position, and a position between the retracted position and the extended position, so as to direct the protective member toward the desired arm. In some embodiments, the protective member is configured to rotate about the suturing device only when the protective member is in one or more selected positions (e.g., a fully retracted position, a fully extended position, or a selected position between the fully retracted and fully extended positions).
在一些实施方案中，缝合装置的保护构件和协作部分可以配置有止动件，从而帮助使用者确定当保护构件转动时，保护构件何时对准缝合线捕捉机构和臂。在其它实施方案中，可以提供多个保护构件而不是具有单个转动保护构件，例如，每个臂有一个保护构件，所述多个保护构件具有对应于每个臂中缝合线座架数量的多个腔。In some embodiments, the protective member and cooperating portion of the suturing device can be configured with stops to help the user determine when the protective member is aligned with the suture capture mechanism and the arm as the protective member rotates. In other embodiments, rather than having a single rotating protective member, multiple protective members can be provided, for example, one protective member per arm, the multiple protective members having multiple cavities corresponding to the number of suture holders in each arm.
图87和88所示的缝合装置可以用于缝合瓣，而无需停止心脏搏动。在一些实施方案中，搏动的心脏的缝合可以允许在操作过程中观察到缝合线放置对瓣的工作的影响，从而通过仅放置修复瓣所需的缝合线而允许使操作适合于具体瓣的需要。例如，如果通过放置初始缝合线不能实现理想的瓣修复，则可以继续使用通过相同进入途径的(例如，通过经心尖开口)相同的装置或其他装置，直至观察到操作成功地在搏动的心脏上实现。当操作者观察到成功时，可以闭合为了实时操作而产生的任何进入途径(例如，经心尖开口)。The suturing devices shown in Figures 87 and 88 can be used to suture a valve without stopping the heart. In some embodiments, suturing of a beating heart can allow the effect of suture placement on the operation of the valve to be observed during the operation, thereby allowing the operation to be tailored to the needs of the specific valve by placing only the sutures required to repair the valve. For example, if the ideal valve repair cannot be achieved by placing the initial sutures, the same device or other devices can be continued using the same access route (e.g., through a transapical opening) until the operation is observed to be successfully achieved on a beating heart. When the operator observes success, any access route (e.g., a transapical opening) created for the real-time operation can be closed.
图89-94示例性地示出利用图87和88的装置的缝合方法，更具体地，显示了在搏动的心脏上实施瓣膜成形术的方法。如图89所示，缝合装置8100的远端8102位于通过瓣(例如二尖瓣8)的通道内，利用上文讨论的任何进入途径并且利用或不利用导丝。使装置前进通过瓣足够的距离，从而允许臂8104能被展开而不损伤瓣或心脏壁。Figures 89-94 illustrate, by way of example, a suturing method utilizing the apparatus of Figures 87 and 88, and more particularly, a method for performing valvuloplasty on a beating heart. As shown in Figure 89, the distal end 8102 of the suturing apparatus 8100 is positioned within a passage through a valve (e.g., the mitral valve 8), utilizing any of the access routes discussed above and with or without a guidewire. The apparatus is advanced through the valve a sufficient distance to allow the arms 8104 to be deployed without damaging the valve or the heart wall.
所示的图89-94示例性地展示了装置经心尖进入二尖瓣8。但是，如本文所讨论的，可以使用其他进入途径，并且可以缝合其他瓣。在图89中，瓣显示为沿着通过缝合装置8100的纵轴的平面的截面。在图90-92中，瓣显示为在两个平面的截面，两个平面都相交与缝合装置8100的纵轴。第一平面沿臂8104延伸，其显示为位于缝合装置的长形体的约9点钟位置。第二平面沿臂8104延伸，其显示为相对于缝合装置的长形体的约5点钟位置。因此，图90-92中显示的5个臂8104大体上位于瓣的瓣叶132上方，位于第6个臂下方的一个瓣叶的一部分在图中隐去。在图91中，瓣的截面的平面大体上通过缝合装置的纵轴并大体上沿着显示为位于5点钟和7点钟位置的臂8104延伸，使得所有6个所示的臂大体上位于瓣8的瓣叶132的上方。图89-94中省略了腱索。Figures 89-94 shown illustrate, by way of example, the device entering the mitral valve 8 through the apex. However, as discussed herein, other access routes may be used, and other valves may be sutured. In Figure 89, the valve is shown as a cross-section along a plane passing through the longitudinal axis of the suturing device 8100. In Figures 90-92, the valve is shown as a cross-section in two planes, both of which intersect with the longitudinal axis of the suturing device 8100. The first plane extends along the arm 8104, which is shown to be located at approximately the 9 o'clock position of the elongated body of the suturing device. The second plane extends along the arm 8104, which is shown to be located at approximately the 5 o'clock position relative to the elongated body of the suturing device. Thus, the five arms 8104 shown in Figures 90-92 are generally located above the leaflets 132 of the valve, and a portion of one leaflet located below the sixth arm is omitted from the figure. In Figure 91 , the plane of the cross-section of the flap passes generally through the longitudinal axis of the suturing device and extends generally along the arms 8104 shown at the 5 and 7 o'clock positions, such that all six illustrated arms are generally positioned above the leaflets 132 of the flap 8. The chordae tendineae are omitted in Figures 89-94.
当臂伸出后，可以通过瓣8收回装置8100，从而使臂的端部位于或邻近瓣8的基部，如图90所示。在某些实施方案中，臂的长度不是精确对应于瓣的尺寸。在这些实施方案中，可以将其中两个臂置于相对于瓣的基部的希望的位置，即，希望放置缝合线的位置。然后，使保护构件8107从缩回位置运动至展开位置，如图91所示。When the arms are extended, the device 8100 can be retracted through the flap 8 so that the ends of the arms are at or near the base of the flap 8, as shown in Figure 90. In some embodiments, the length of the arms does not exactly correspond to the size of the flap. In these embodiments, two of the arms can be placed in the desired position relative to the base of the flap, i.e., the position where the suture is desired to be placed. The protective member 8107 is then moved from the retracted position to the extended position, as shown in Figure 91.
如图91所示，当保护构件8107展开后，可以将保护构件8107运动至在缝合臂8104之间成角度的位置。在其他实施方案中，当保护构件8107展开后，可以将保护构件8107置于相对于缝合装置8100的长形体的、对准缝合臂的至少一个缝合线座架的转动位置。在一些实施方案中，保护构件能在臂之间运动的能力可以是有利的。例如，保护构件在臂之间运动可以允许保护构件绕装置在对准第一臂8104A的位置(如图92所示)和对准第二臂8104B的位置(如图93所示)之间转动，而不会损伤腱索。该特征还可以有助于避免保护构件8107与腱索缠绕，因为展开和收回发生的情况数量减少。As shown in Figure 91, after the protective member 8107 is deployed, the protective member 8107 can be moved to a position that is angled between the suturing arms 8104. In other embodiments, after the protective member 8107 is deployed, the protective member 8107 can be placed in a rotational position relative to at least one suture holder of the elongated body of the suturing device 8100 that is aligned with the suturing arms. In some embodiments, the ability of the protective member to move between the arms can be advantageous. For example, the movement of the protective member between the arms can allow the protective member to rotate around the device between a position aligned with the first arm 8104A (as shown in Figure 92) and a position aligned with the second arm 8104B (as shown in Figure 93) without damaging the chordae tendineae. This feature can also help to avoid the protective member 8107 from being entangled with the chordae tendineae because the number of situations in which deployment and retraction occur is reduced.
在一个实施方案中，保护构件8107被首先展开并与第一臂8104A的缝合线座架8126对准，如图92所示。保护构件8107的端部可以位于臂8104A的端部的附近，但是位于瓣132的组织的另一侧。在一些实施方案中，保护构件8107的端部远离臂8104A数毫米。在其他实施方案中，该距离可以调整。第一缝合线捕捉机构(例如针)可以通过保护构件8107的其中一个腔展开，通过瓣132的组织并进入第一臂8104A的缝合线座架8126A。收回缝合线捕捉机构能携带第一缝合线端部部分通过瓣132的组织并进入长形体。92 . The end of the protective member 8107 can be located near the end of the arm 8104A, but on the other side of the tissue of the flap 132. In some embodiments, the end of the protective member 8107 is several millimeters away from the arm 8104A. In other embodiments, this distance can be adjusted. A first suture capture mechanism (e.g., a needle) can be deployed through one of the lumens of the protective member 8107, through the tissue of the flap 132 and into the suture mount 8126A of the first arm 8104A. The retracting suture capture mechanism can carry the first suture end portion through the tissue of the flap 132 and into the elongated body.
当缝合线捕捉机构被收回并且保护构件8107展开时，可以转动保护构件，使之与第二臂8104B的缝合线座架对准，例如，如图93所示。第二缝合线捕捉机构(例如针)可以通过保护构件8107的另一个腔展开，通过瓣132的组织并进入第二臂的缝合线座架8126B。优选地，第二臂的缝合线座架保持第一臂中安装的缝合线的第二端。收回缝合线捕捉机构能携带第二缝合线端部部分通过瓣132的组织并进入长形体。此时，缝合装置已经合适地以对应于两个邻近缝合臂的端部之间的角度距离的角度距离将缝合线置于瓣的周边。When the suture capture mechanism is retracted and the protective member 8107 is deployed, the protective member can be rotated to align with the suture holder of the second arm 8104B, for example, as shown in Figure 93. A second suture capture mechanism (e.g., a needle) can be deployed through another cavity of the protective member 8107, through the tissue of the flap 132 and into the suture holder 8126B of the second arm. Preferably, the suture holder of the second arm holds the second end of the suture mounted in the first arm. Retracting the suture capture mechanism can carry the second suture end portion through the tissue of the flap 132 and into the elongated body. At this point, the suturing device has appropriately placed the sutures around the periphery of the flap at an angular distance corresponding to the angular distance between the ends of the two adjacent suturing arms.
在此时的操作中，仅使用来自第一臂和第二臂的缝合线座架中的一个，优选地，离对应的邻近臂最近的缝合线座架。然后，可以收回保护构件8107，并将其转动至另一对臂(例如第二臂和第三臂)之间的位置。也可以根据需要重新定位装置8100，使得第二和第三臂可以位于瓣132的基部处需要的位置。然后重复结合图90-93所讨论的步骤，从而使第二缝合通过瓣中两个另外的位置。在对每对邻近缝合臂重复这些步骤的实施方案中，6个缝合线130可以通过瓣，如图94示例性所示。然后，可以通过任何已知的方法(例如本文讨论的方法)将每个缝合线的相对端部拉紧并牢固地保持在一起。At this point in the operation, only one of the suture holders from the first arm and the second arm is used, preferably, the suture holder closest to the corresponding adjacent arm. The protective member 8107 can then be retracted and rotated to a position between another pair of arms (e.g., the second arm and the third arm). The device 8100 can also be repositioned as needed so that the second and third arms can be located at the desired position at the base of the flap 132. The steps discussed in conjunction with Figures 90-93 are then repeated to pass the second suture through two additional locations in the flap. In an embodiment in which these steps are repeated for each pair of adjacent suture arms, six sutures 130 can pass through the flap, as exemplified in Figure 94. The opposite ends of each suture can then be tightened and held securely together by any known method, such as the methods discussed herein.
在一些实施方案中，结合图89-94所描述的相似的方法可以用于将修复装置附接至心脏组织。In some embodiments, similar methods as described in connection with Figures 89-94 can be used to attach the repair device to cardiac tissue.
具有两个臂的缝合装置和方法，例如用于缝合瓣的基部Suturing device and method having two arms, such as for suturing the base of a flap
图95-97示出缝合装置9100的实施方案，缝合装置9100可以用于缝合解剖学瓣，例如心脏瓣膜。例如，缝合装置9100(以及上文所述的相似装置)可以用于实施折襞(plication)的瓣膜成形术，其中缝合线被施加于瓣的一部分，并且缝合线被拉紧从而减小瓣的尺寸，进而对瓣进行重塑。图95-97所示的缝合装置9100在某些方面与上文说明和描述的缝合装置相似。例如，缝合装置可以包括长形体9142和远侧组件9102，远侧组件9102可以具有一个或多个缝合臂9104，如上文所述的图87和88的缝合装置。如图所示，缝合装置在每个缝合臂9104上仅具有单个缝合线座架9126，但是在一些实施方案中，缝合装置在每个缝合臂9104上可以具有多个缝合线座架9126。如上文所述，缝合线座架9126可以被配置为能可释放地保持缝合线部分。Figures 95-97 show an embodiment of a suturing device 9100, which can be used to suturing anatomical valves, such as heart valves. For example, the suturing device 9100 (and similar devices described above) can be used to perform a plication valvuloplasty, in which a suture is applied to a portion of the valve and the suture is tightened to reduce the size of the valve, thereby reshaping the valve. The suturing device 9100 shown in Figures 95-97 is similar in some respects to the suturing device illustrated and described above. For example, the suturing device can include an elongated body 9142 and a distal assembly 9102, which can have one or more suturing arms 9104, such as the suturing devices of Figures 87 and 88 described above. As shown, the suturing device has only a single suture holder 9126 on each suturing arm 9104, but in some embodiments, the suturing device can have multiple suture holders 9126 on each suturing arm 9104. As described above, the suture holder 9126 can be configured to releasably hold the suture portion.
在一些实施方案中，缝合装置可以具有多个缝合臂9104和多个保护构件或针臂9107。在所示实施方案中，该装置具有两个缝合臂9104A、B和单个针臂9107。臂的配置和展开以及操作缝合装置的其他特征和方式可以显示和描述于美国专利6,911,034，通过引用的方式将其整体并入本文。可以使缝合臂位于装置的远端的附近，并且针臂可以位于缝合臂的近侧，如图95-97所示。缝合臂和针臂可以各具有缩回位置，在缩回位置时，它们被收入长形体，如图96所示。每个缝合臂还可以具有伸出位置，在伸出位置时，缝合臂绕一端转动并远离长形体伸出。在一些实施方案中，当臂9104A、B处于伸出位置时，臂9104A、B可以垂直于长形体的纵轴延伸。针臂也可以展开到伸出位置，在伸出位置时，针臂远离长形体伸出并朝向长形体的远端。图97显示了缝合臂和针臂都处于伸出位置的实施方案。In some embodiments, the suturing device may have multiple suturing arms 9104 and multiple protective members or needle arms 9107. In the illustrated embodiment, the device has two suturing arms 9104A, B and a single needle arm 9107. The configuration and deployment of the arms, as well as other features and methods of operating the suturing device, can be shown and described in U.S. Patent 6,911,034, which is incorporated herein by reference in its entirety. The suturing arm can be located near the distal end of the device, and the needle arm can be located proximal to the suturing arm, as shown in Figures 95-97. The suturing arm and the needle arm can each have a retracted position, in which they are retracted into the elongated body, as shown in Figure 96. Each suturing arm can also have an extended position, in which the suturing arm rotates around one end and extends away from the elongated body. In some embodiments, when the arms 9104A, B are in the extended position, the arms 9104A, B can extend perpendicular to the longitudinal axis of the elongated body. The needle arm can also be deployed to an extended position, in which the needle arm extends away from the elongated body and toward the distal end of the elongated body. Figure 97 shows an embodiment in which both the suturing arm and the needle arm are in the extended position.
如上文所述，各个实施方案可以具有不同长度的臂9104A、B，从而适应待缝合的具体瓣和目标患者的解剖学结构的尺寸。在一些实施方案中，设定臂的尺寸和配置，使得当装置在瓣中并且臂被展开时，臂上的每个缝合线座架位于或邻近瓣的基部。在一些实施方案中，当臂已展开并且缝合线座架位于或邻近瓣的基部时，针臂可以位于瓣的另一侧。在一些实施方案中，处于伸出位置的针臂可以延伸而与缝合臂的缝合线座架的对准，但是瓣位于它们之间。另外，在一些实施方案中，缝合臂可以在远端、在当缝合臂伸出时面向长形体近端的表面上包括尖利边缘10105或任何钩、尖端、针尖、刻痕或其他粗糙结构，如图98所示。尖利边缘或其他粗糙结构可以帮助缝合臂保持在抵靠解剖学瓣的组织的位置。As described above, various embodiments can have arms 9104A, B of different lengths to accommodate the size of the specific flap to be sutured and the anatomical structure of the target patient. In some embodiments, the arms are sized and configured so that when the device is in the flap and the arms are deployed, each suture holder on the arm is located at or adjacent to the base of the flap. In some embodiments, when the arms are deployed and the suture holder is located at or adjacent to the base of the flap, the needle arm can be located on the other side of the flap. In some embodiments, the needle arm in the extended position can be extended to align with the suture holder of the suture arm, but with the flap located between them. In addition, in some embodiments, the suture arm can include a sharp edge 10105 or any hook, point, needle point, notch or other rough structure at the distal end, on the surface facing the proximal end of the elongated body when the suture arm is extended, as shown in Figure 98. The sharp edge or other rough structure can help the suture arm remain in position against the tissue of the anatomical flap.
还如上文所述，针臂9107可以被配置为能保护周围组织免受缝合线捕捉机构运动的影响，在一些实施方案中，缝合线捕捉机构可以是针9106。针臂可以包括一个或多个腔9150，一个或多个针9106可以从中通过。在图97所示的实施方案中，针臂具有两个腔，每个腔可以与针9106和缝合线座架9126相关联。As also described above, the needle arm 9107 can be configured to protect surrounding tissue from the movement of a suture capture mechanism, which in some embodiments can be a needle 9106. The needle arm can include one or more lumens 9150 through which one or more needles 9106 can pass. In the embodiment shown in FIG97 , the needle arm has two lumens, each of which can be associated with a needle 9106 and a suture holder 9126.
在一些实施方案中，针臂可以绕长形体转动。如图97所示，针臂可以在两个缝合臂9104A、B之间延伸。在图99中，针臂已转动而与缝合臂9104A和缝合线座架9126A之一对准。图99显示了长形体的一部分的截面图，缝合臂9104A和保护构件9107处于伸出位置，针臂对准缝合臂9104A。如图所示，针9106位于针臂9107内。在一些实施方案中，在针臂展开至其伸出位置之前，针9106可以位于针臂内。In some embodiments, the needle arm can be rotated about the elongated body. As shown in FIG. 97 , the needle arm can extend between the two suturing arms 9104A, B. In FIG. 99 , the needle arm has been rotated to align with the suturing arm 9104A and one of the suture holders 9126A. FIG. 99 shows a cross-sectional view of a portion of the elongated body with the suturing arm 9104A and the protective member 9107 in the extended position, with the needle arm aligned with the suturing arm 9104A. As shown, the needle 9106 is positioned within the needle arm 9107. In some embodiments, the needle 9106 can be positioned within the needle arm before the needle arm is deployed to its extended position.
在一些实施方案中，长形体可以包括旋转套管9160，其可以围绕内部圆柱体并且当针臂处于缩回位置时可以容纳针9106和针臂9107。如图所示，当针臂处于其伸出位置时，针前进通过旋转套管，离开旋转套管进入缺口并然后进入针臂。在一些实施方案中，针可以直接进入针臂，而不需首先通过旋转套管和针臂之间的缺口。在一些实施方案中，如下文更详细讨论地，针的至少一部分可以位于突出部内。在一些实施方案中，突出部可以仅位于针臂内。在一些实施方案中，当针臂处于其伸出位置时，突出部可以从针臂伸出进入旋转套管。In some embodiments, the elongated body can include a rotating sleeve 9160 that can surround the inner cylinder and can accommodate the needle 9106 and needle arm 9107 when the needle arm is in the retracted position. As shown, when the needle arm is in its extended position, the needle advances through the rotating sleeve, exits the rotating sleeve, enters the gap and then enters the needle arm. In some embodiments, the needle can enter the needle arm directly without first passing through the gap between the rotating sleeve and the needle arm. In some embodiments, as discussed in more detail below, at least a portion of the needle can be located within the protrusion. In some embodiments, the protrusion can be located only within the needle arm. In some embodiments, when the needle arm is in its extended position, the protrusion can extend from the needle arm into the rotating sleeve.
当针臂开始从旋转套管内的缩回位置向伸出位置运动时，其首先向远侧运动，直至接合伸出表面9164。伸出表面与针臂远离长形体成角，使得当针臂继续向前移动时，其同时远离长形体并朝向长形体远端运动。在一些实施方案中，伸出表面9164可以为约45°角。在一些实施方案中，针臂可以以约45°角伸出。在其他实施方案中，伸出表面可以小于或大于45°，针臂可以于或大于45°。当收回针臂时，其可以接合抵靠收回表面9166，收回表面9166可以引导针臂返回其旋转套管9160内的缩回位置。在一些实施方案中，收回表面可以包括缺口，该缺口可以允许针和/或突出部从其通过。As the needle arm begins to move from the retracted position within the rotating sleeve to the extended position, it first moves distally until it engages the extension surface 9164. The extension surface is angled with the needle arm away from the elongated body so that as the needle arm continues to move forward, it simultaneously moves away from the elongated body and toward the distal end of the elongated body. In some embodiments, the extension surface 9164 can be at an angle of approximately 45°. In some embodiments, the needle arm can extend at an angle of approximately 45°. In other embodiments, the extension surface can be less than or greater than 45°, and the needle arm can be less than or greater than 45°. When the needle arm is retracted, it can engage against the retraction surface 9166, which can guide the needle arm back to its retracted position within the rotating sleeve 9160. In some embodiments, the retraction surface can include a notch that can allow the needle and/or protrusion to pass therethrough.
在一些实施方案中，旋转套管9160可以被配置为能绕长形体的纵轴转动。在一些实施方案中，除了能转动外，旋转套管可以沿内部圆柱体向近侧或向远侧运动。在旋转套管转动，针臂可以随之转动。如结合图87和88所描述的，在各个实施方案中，套管和针臂可以被配置为能在针臂处于缩回位置、伸出位置和/或缩回位置和伸出位置之间的位置时转动，从而将针臂指向所需要的臂。在一些实施方案中，当针臂指向所需要的臂时，针臂和缝合臂之间可以存在大于或等于3毫米(或约3毫米)和/或小于或等于5毫米(或约5毫米)的缺口。在一些实施方案中，针臂可以指在两个臂之间，并且针臂和两个臂所在的平面之间可以存在大于或等于3毫米(或约3毫米)和/或小于或等于5毫米(或约5毫米)的缺口。In some embodiments, the rotating sleeve 9160 can be configured to rotate around the longitudinal axis of the elongated body. In some embodiments, in addition to being able to rotate, the rotating sleeve can move proximally or distally along the inner cylinder. When the rotating sleeve rotates, the needle arm can rotate therewith. As described in conjunction with Figures 87 and 88, in various embodiments, the sleeve and the needle arm can be configured to rotate when the needle arm is in a retracted position, an extended position and/or a position between the retracted position and the extended position, thereby pointing the needle arm to the desired arm. In some embodiments, when the needle arm points to the desired arm, there may be a gap greater than or equal to 3 mm (or approximately 3 mm) and/or less than or equal to 5 mm (or approximately 5 mm) between the needle arm and the suture arm. In some embodiments, the needle arm can be pointed between the two arms, and there may be a gap greater than or equal to 3 mm (or approximately 3 mm) and/or less than or equal to 5 mm (or approximately 5 mm) between the needle arm and the plane where the two arms are located.
在一些实施方案中，长形体可以具有一个或多个止动件9162，其位置可以为，使得随着旋转套管转动，当针臂与缝合臂9104对准时，旋转套管可以接合止动件。在一些实施方案中，止动件可以被配置为使得随着旋转套管接合止动件，套管向远侧运动。在一些实施方案中，通过在套管和止动件之间制造卡口连接可以实现这一点。旋转套管向远侧运动可以向远侧驱动针臂，并且可以被配置为使得针臂接合瓣的组织，夹紧组织和缝合臂之间的瓣。如果针臂转动回来，旋转套管可以脱离止动件，向近侧运动并释放瓣。在一些实施方案中，当针臂与缝合臂对准时，针臂可以向远侧运动，而不夹紧瓣。在一些实施方案中，当针臂与缝合臂对准时，针臂可以向远侧运动，但是可以转动回来，而不向近侧运动。In some embodiments, the elongated body may have one or more stops 9162 positioned so that as the rotating sleeve rotates, the rotating sleeve can engage the stops when the needle arm is aligned with the suturing arm 9104. In some embodiments, the stops can be configured so that as the rotating sleeve engages the stops, the sleeve moves distally. In some embodiments, this can be achieved by creating a bayonet connection between the sleeve and the stop. The distal movement of the rotating sleeve can drive the needle arm distally and can be configured so that the needle arm engages the tissue of the flap, clamping the flap between the tissue and the suturing arm. If the needle arm rotates back, the rotating sleeve can disengage the stops, move proximally and release the flap. In some embodiments, when the needle arm is aligned with the suturing arm, the needle arm can move distally without clamping the flap. In some embodiments, when the needle arm is aligned with the suturing arm, the needle arm can move distally, but can rotate back without moving proximally.
夹紧瓣可以便于缝合瓣，而无需停止心脏搏动，因为其可以帮助确保所希望的缝合线放置。如上文所讨论的，缝合搏动中的心脏可以允许在操作中观察到缝合线放置对瓣的工作的影响，从而通过仅放置修复瓣所需的缝合线而允许操作适合于具体瓣的需要。例如，如果通过放置初始缝合线没有实现理想的瓣修复，则可以通过相同的进入途径(例如，通过经心尖开口)继续使用相同装置或其他装置，直至观察到操作在搏动的心脏上成功了。一旦操作者观察到成功，可以闭合为了实施操作所制造的任何进入途径(例如，经心尖开口)。Clamping the valve can facilitate suturing the valve without stopping the heart because it can help ensure desired suture placement. As discussed above, suturing a beating heart can allow the effect of suture placement on the operation of the valve to be observed during the operation, thereby allowing the operation to be tailored to the needs of the specific valve by placing only the sutures required to repair the valve. For example, if the ideal valve repair is not achieved by placing the initial sutures, the same device or another device can be continued through the same access route (e.g., through a transapical opening) until the operation is observed to be successful on a beating heart. Once the operator observes success, any access route (e.g., a transapical opening) created to perform the operation can be closed.
图100从远端显示了缝合装置的视图。如图所示，第一和第二缝合臂9104A、B已伸出，并彼此成约90°远离长形体伸出。在一些实施方案中，缝合臂的位置可以彼此成少于90°，在其他实施方案中，缝合臂的位置可以彼此成多于90°。缝合线座架9126A、B之间的距离9127可以限定缝合线或在实施瓣膜成形术时可以拉紧的其他元件的初始宽度。在一些实施方案中，距离9127可以大于或等于10毫米(或约10毫米)和/或小于或等于15毫米(或约15毫米)。图100还显示了导丝10和导丝可以通过的导丝腔9111。如上文所讨论的，在一些实施方案中，装置可以在导丝上前进而到达心脏内的位置。Figure 100 shows a view of the suturing device from the distal end. As shown, the first and second suturing arms 9104A, B have been extended and extend away from the elongated body at approximately 90° from each other. In some embodiments, the suturing arms can be positioned at less than 90° from each other, and in other embodiments, the suturing arms can be positioned at more than 90° from each other. The distance 9127 between the suture holders 9126A, B can define the initial width of the suture or other elements that can be tightened when performing a valvuloplasty. In some embodiments, the distance 9127 can be greater than or equal to 10 mm (or approximately 10 mm) and/or less than or equal to 15 mm (or approximately 15 mm). Figure 100 also shows a guidewire 10 and a guidewire lumen 9111 through which the guidewire can pass. As discussed above, in some embodiments, the device can be advanced over the guidewire to reach a position within the heart.
图101显示了针臂9107的远端的截面图。在一些实施方案中，针臂可以具有一个或多个针可以通过的通道。在一些实施方案中，如图所示，针臂可以具有一个或多个位于针臂的一个或多个通道内的突出部9170。突出部可以被配置为能容纳针9106，如图所示。在一些实施方案中，针臂可以具有一个或多个斜坡(draft)9174、隧道9172和/或缝合线保留区域9176，其中突出部仅能延伸至斜坡9174。斜坡9174可以引导针进入隧道9172，这可以帮助确保针对准通过缝合线扣或座架9126并容纳一段缝合线。缝合线保留区域9176的尺寸可以足以容纳针和被针捕捉的一段缝合线。在一些实施方案中，在针臂展开至伸出位置之前，针9106可以被预加载至所示的位置，延伸通过突出部并通过隧道9172。在一些实施方案中，针可以被预加载至针臂和/或突出部内的其他位置，例如，突出部内、但远离隧道。图101(或本文其他部分所述的任何实施方案)所示的针9106可以在其远端具有钩，从而接合臂9104A或9104B所保持的一段缝合线。本文所述的(或说明书中其他部分)缝合线可以具有平的端部，在其中形成用于接合针的孔，如美国专利7,090,686中所述，通过引用将该文献整体并入本文。Figure 101 shows a cross-sectional view of the distal end of the needle arm 9107. In some embodiments, the needle arm can have one or more channels through which the needle can pass. In some embodiments, as shown, the needle arm can have one or more protrusions 9170 located within the one or more channels of the needle arm. The protrusions can be configured to accommodate the needle 9106, as shown. In some embodiments, the needle arm can have one or more drafts 9174, tunnels 9172, and/or suture retention areas 9176, wherein the protrusions can only extend to the ramps 9174. The ramps 9174 can guide the needle into the tunnels 9172, which can help ensure that the needle is aligned through the suture buckle or holder 9126 and accommodates a length of suture. The suture retention area 9176 can be sized to accommodate the needle and a length of suture captured by the needle. In some embodiments, before the needle arm is deployed to the extended position, the needle 9106 can be preloaded to the position shown, extending through the protrusions and through the tunnel 9172. In some embodiments, the needle can be preloaded to other locations within the needle arm and/or protrusion, for example, within the protrusion but away from the tunnel. The needle 9106 shown in Figure 101 (or any embodiment described elsewhere herein) can have a hook at its distal end to engage a section of suture held by arm 9104A or 9104B. The suture described herein (or elsewhere in the specification) can have a flat end in which a hole for engaging the needle is formed, as described in U.S. Patent 7,090,686, which is incorporated herein by reference in its entirety.
在一些实施方案中，针臂可以具有单个突出部9170，突出部9170具有一个或多个腔9150的。图102显示了具有两个腔9150的突出部9170的顶视图，两个腔9150配置为能保持两个针9106。在一些实施方案中，针臂可以具有多个突出部，每个突出部与一个或多个针相关联。在一些实施方案中，如上文所述，针臂可以具有对每个腔和/或针的斜坡、隧道和/或缝合线保持区域。在图102中，突出部具有平行侧面和圆形角落。在其他实施方案中，突出部可以为方形、圆形、卵形或可以适应于针臂的任何形状。突出部的各种实施方案和配置可以与本申请讨论的任何保护构件(“针臂”)一起使用。In some embodiments, the needle arm can have a single protrusion 9170 having one or more cavities 9150. Figure 102 shows a top view of a protrusion 9170 having two cavities 9150 configured to hold two needles 9106. In some embodiments, the needle arm can have multiple protrusions, each associated with one or more needles. In some embodiments, as described above, the needle arm can have a slope, tunnel, and/or suture holding area for each cavity and/or needle. In Figure 102, the protrusion has parallel sides and rounded corners. In other embodiments, the protrusion can be square, round, oval, or any shape that can be adapted to the needle arm. The various embodiments and configurations of the protrusion can be used with any of the protective members ("needle arms") discussed herein.
图103-112示例性地示出利用缝合装置实施瓣膜成形术的一种方法。所示操作表示装置经心尖进入二尖瓣8，但是，如本文所讨论的，可以使用其他进入途径，包括装置从心房侧进入瓣的途径，并且可以缝合其他瓣。装置还可以在利用或不利用导丝的情况下进入瓣。未显示瓣的周围组织，在图103中，装置的远端已被插过瓣，缝合臂9104A、B和针臂9107处于缩回位置。针臂的位置在两个臂之间大致等距，但是在一些实施方案中，针臂的位置可以离一个臂或另一个臂较近。还示例性地示出腱索133，腱索133从瓣的心室侧伸出。Figures 103-112 illustrate, by way of example, a method of performing valvuloplasty using a suturing device. The operation shown represents transapical entry of the device into the mitral valve 8, however, as discussed herein, other approaches to entry may be used, including approaches where the device enters the valve from the atrial side, and other valves may be sutured. The device may also enter the valve with or without the use of a guidewire. The tissue surrounding the valve is not shown, and in Figure 103, the distal end of the device has been inserted through the valve, with the suturing arms 9104A, B and needle arm 9107 in a retracted position. The needle arm is positioned approximately equidistant between the two arms, but in some embodiments, the needle arm may be positioned closer to one arm or the other. Also illustrated are chordae tendineae 133, which extend from the ventricular side of the valve.
缝合臂可以被置于伸出位置，如图104所示。在一些实施方案中，它们可以同时到达伸出位置，在一些实施方案中，一个臂可以先开始伸出或到达伸出位置，之后另一个臂开始伸出。缝合臂伸出时，可以收回装置，直至臂接合瓣的组织，如图105所示。如图所示，缝合线座架9126A、B在同一瓣叶沿着瓣的基部。在一些实施方案中，臂不是一直伸到瓣的基部，在一些实施方案中，每个臂可以在不同瓣叶上。The suturing arms can be placed in an extended position, as shown in FIG104. In some embodiments, they can reach the extended position simultaneously, and in some embodiments, one arm can begin to extend or reach the extended position before the other arm begins to extend. As the suturing arms extend, the device can be retracted until the arms engage the tissue of the valve, as shown in FIG105. As shown, the suture holders 9126A, B are on the same leaflet along the base of the valve. In some embodiments, the arms do not extend all the way to the base of the valve, and in some embodiments, each arm can be on a different leaflet.
在缝合臂伸出或装置被收回使得缝合臂可以接合瓣的组织之前、之后或过程中，针臂可以被展开至初始伸出位置，例如，通过腱索。图106显示了处于伸出位置的针臂和保持在瓣上的缝合臂。然后，针臂9107可以朝向第一臂9104A转动，直至其对准臂，如图107所示。如上文所讨论的，在一些实施方案中，当针臂对准臂时，其可以向远侧伸出并夹紧缝合臂和针臂之间的瓣。在其他实施方案中，针臂和瓣之间可以存在缺口。The needle arm can be deployed to an initial extended position, for example, by chordae tendineae, before, after, or during the extension of the suturing arm or the retraction of the device so that the suturing arm can engage the tissue of the flap. Figure 106 shows the needle arm in an extended position and the suturing arm retained on the flap. The needle arm 9107 can then be rotated toward the first arm 9104A until it is aligned with the arm, as shown in Figure 107. As discussed above, in some embodiments, when the needle arm is aligned with the arm, it can extend distally and clamp the flap between the suturing arm and the needle arm. In other embodiments, there can be a gap between the needle arm and the flap.
随着针臂转动，其可以使腱索133转移到位于针臂和第一臂之间的位置。使针臂最初位于两个臂9104A、B之间等距的位置的一个优势在于最小化针臂可能需要到达每个臂的距离，这可以最小化任何移位的腱索上的应力。优选地，当针臂伸出时，针臂位于邻近腱索之间，使得针臂在第一和第二臂之间的运动不会导致针臂与腱索缠绕在一起。As the needle arm rotates, it can cause the chordae 133 to shift to a position between the needle arm and the first arm. One advantage of initially positioning the needle arm equidistant between the two arms 9104A, B is that it minimizes the distance the needle arm may need to reach each arm, which can minimize stress on any displaced chordae. Preferably, when the needle arm is extended, the needle arm is positioned between adjacent chordae so that movement of the needle arm between the first and second arms does not cause the needle arm to become entangled with the chordae.
当针臂对准缝合臂时，针9106A可以伸出针臂并通过缝合线座架9126A，如图108所示。如上文所讨论的，收回针可以携带来自缝合线座架的第一缝合线端部，通过瓣的组织并进入长形体。然后，针臂可以转动回其初始伸出位置，携带着一段缝合线130A，如图109所示。When the needle arm is aligned with the suture arm, the needle 9106A can be extended from the needle arm and passed through the suture holder 9126A, as shown in Figure 108. As discussed above, the retraction needle can carry the first suture end from the suture holder, through the tissue of the flap and into the elongated body. The needle arm can then be rotated back to its initial extended position, carrying a length of suture 130A, as shown in Figure 109.
从初始伸出位置，针臂9107可以朝向第二臂9104B转动，直至其对准臂，如图110所示。在一些实施方案中，针臂可以抵靠臂夹紧瓣组织，如上文所讨论的。还如上文所讨论的以及如图所示，针臂可以使腱索133移位于针臂和第二臂9104B之间。From the initial extended position, the needle arm 9107 can be rotated toward the second arm 9104B until it is aligned with the arm, as shown in Figure 110. In some embodiments, the needle arm can clamp the flap tissue against the arm, as discussed above. Also as discussed above and shown in the figures, the needle arm can displace the chordae tendineae 133 between the needle arm and the second arm 9104B.
单独的针9106B可以延伸通过针臂并通过缝合线座架，如图111所示，然后，与第二缝合线端部收入长形体。然后，针臂可以返回其初始伸出位置，如图112所示，其中一段缝合线从每个臂伸出通过瓣并进入针臂。在一些实施方案中，长形体可以具有初始止动件，其告知使用者针臂何时返回其初始伸出位置。A separate needle 9106B can be extended through the needle arm and through the suture holder, as shown in FIG111 , and then retracted into the elongated body with the second suture end. The needle arm can then be returned to its initial extended position, as shown in FIG112 , with a length of suture extending from each arm through the flap and into the needle arm. In some embodiments, the elongated body can have an initial stop that tells the user when the needle arm has returned to its initial extended position.
缝合臂和针臂可以收入长形体。在一些实施方案中，在针臂返回初始伸出位置之间或针臂不返回初始伸出位置的情况下，针臂和/或缝合臂可以收入长形体。一旦针臂和缝合臂被收回，可以从瓣和心脏取出装置，留下缝合线通过瓣。The suturing arm and the needle arm can be retracted into the elongated body. In some embodiments, the needle arm and/or the suturing arm can be retracted into the elongated body before the needle arm returns to the initial extended position or when the needle arm does not return to the initial extended position. Once the needle arm and the suturing arm are retracted, the device can be removed from the valve and the heart, leaving the suture thread through the valve.
在一些实施方案中，两个缝合线端部可以是分别的缝合线的部分，如图113所示。通过按照任何已知方法系出结134或通过施加结134(例如，2007年1月11日公开的美国专利公开2007/0010829A1中所述，通过引用的方式将上述文献整体并入本文并作为说明书的一部分)，可以将通过瓣中的缺口的两个缝合线端部牢固地保持在一起。图114显示了被连接在一起的缝合线。在一些实施方案中，两个缝合线端部可以是同一缝合线的端部，并且无需如图113所示将两个缝合线端部牢固地保持在一起。In some embodiments, the two suture ends can be parts of separate sutures, as shown in FIG113. The two suture ends passing through the notch in the flap can be securely held together by tying a knot 134 according to any known method or by applying a knot 134 (e.g., as described in U.S. Patent Publication 2007/0010829A1, published on January 11, 2007, which is incorporated herein by reference in its entirety and made a part of the specification). FIG114 shows the sutures connected together. In some embodiments, the two suture ends can be ends of the same suture, and there is no need to securely hold the two suture ends together as shown in FIG113.
然后，可以拉动一个或多个松散的缝合线末端，如结合图50和51所述，使缝合抵靠瓣。可以将剩余的端部拉紧并按照上文所述的任何方法打结(例如图69和70以及伴随的描述)，从而将缝合线穿透的位置拉在一起。在一些实施方案中，如上文所述，一组缝合线穿透部位之间的初始距离可以大于或等于10毫米(或约10毫米)和/或小于或等于15毫米(或约15毫米)。在一些实施方案中，一组缝合线穿透部位之间的距离可以被拉近到大于或等于6毫米(或约6毫米)和/或小于或等于8毫米(或约8毫米)的第二距离。一组缝合线穿透部位之间的连接可以称为折襞，并且在一些实施方案中，可以利用缝合装置将多个折襞插入瓣。折襞的位置和尺寸可以将瓣按照需要的处理目标再塑形。Then, one or more loose suture ends can be pulled, as described in conjunction with Figures 50 and 51, to suture against the flap. The remaining ends can be tightened and tied according to any method described above (e.g., Figures 69 and 70 and the accompanying description), thereby pulling the positions of the suture penetrations together. In some embodiments, as described above, the initial distance between a group of suture penetration sites can be greater than or equal to 10 mm (or approximately 10 mm) and/or less than or equal to 15 mm (or approximately 15 mm). In some embodiments, the distance between a group of suture penetration sites can be drawn closer to a second distance that is greater than or equal to 6 mm (or approximately 6 mm) and/or less than or equal to 8 mm (or approximately 8 mm). The connection between a group of suture penetration sites can be referred to as a plication, and in some embodiments, a plurality of plications can be inserted into the flap using a suturing device. The position and size of the plication can reshape the flap according to the desired treatment target.
在一些实施方案中，管9137可以插在缝合线上，如图115所示，该图是具有折襞的瓣的截面图。管可以由金属或塑料制成，例如聚丙烯，并且可以是直的或弯曲的。在两个缝合线端部是分别的缝合线的部分的实施方案中，在将缝合线端部牢固地保持在一起之前，可以将管插在其中一个通过瓣中的缺口的缝合线端部上。在一些实施方案中，管9137可以固定于通过瓣中过的缺口的分别的缝合线的两个自由端，而不是在连接的缝合线上轻松地滑动。然后，可以拉动松散的端部，直至管抵靠瓣或邻近瓣。在两个缝合线端部是同一缝合线的部分的实施方案中，可以在将缝合线附接至装置之前，将管插在缝合线上和/或附接至缝合线，或在一些实施方案中，可以在将缝合线附接至装置之后，将管附接至缝合线。可以将管设置为所需的长度，并且可以帮助控制缝合穿透位置被拉在一起的距离，如图116所示。在一些实施方案中，可以使用填料来代替管。管或填料就位后，可以在瓣的另一侧上施加结，如图116所示。In some embodiments, a tube 9137 can be inserted over the sutures, as shown in FIG115 , which is a cross-sectional view of a flap with plications. The tube can be made of metal or plastic, such as polypropylene, and can be straight or curved. In embodiments where the two suture ends are part of separate sutures, the tube can be inserted over one of the suture ends passing through the indentation in the flap before the suture ends are securely held together. In some embodiments, the tube 9137 can be secured to the two free ends of the separate sutures passing through the indentation in the flap, rather than sliding easily over the connected sutures. The loose ends can then be pulled until the tube rests against the flap or an adjacent flap. In embodiments where the two suture ends are part of the same suture, the tube can be inserted over and/or attached to the suture before attaching it to the device, or in some embodiments, after the suture is attached to the device. The tube can be set to a desired length and can help control the distance the suture penetration sites are pulled together, as shown in FIG116 . In some embodiments, a filler can be used in place of the tube. After the tube or filler is in place, a knot can be applied on the other side of the flap, as shown in Figure 116.
在一些实施方案中，为了保持多个折襞之间一致的拉紧程度或监测单个折襞的拉紧程度，可以将应变仪连接于缝合线。在一些实施方案中，应变仪可以构建在装置的手柄中。可以拉紧折襞，直至应变仪指示理想的值。在一些实施方案中，可以将第一折襞拉紧至所需的距离，并记录应变仪所测量的值。然后，可以拉紧随后折襞至大约相同的应变仪读数。In some embodiments, a strain gauge can be attached to the suture to maintain consistent tension between multiple plications or to monitor the tension of a single plication. In some embodiments, the strain gauge can be built into the handle of the device. The plications can be tightened until the strain gauge indicates a desired value. In some embodiments, the first plication can be tightened to the desired distance, and the value measured by the strain gauge recorded. Then, subsequent plications can be tightened to approximately the same strain gauge reading.
由于当针臂在两个缝合臂之间转动时腱索被推在旁边，因此心室侧上的缝合线可以大体上在缝合穿透位置之间的直线路径延伸。这可以帮助防止对腱索的不必要的应力，如果缝合线从一个缝合穿透位置运行至下一个缝合穿透位置时采取围绕腱索的迂曲的途径，则会产生这样的应力。拉紧缝合线能将缝合线抵靠一个或多个腱索的基部拉紧，这可能会损伤腱索。Because the chordae tendineae are pushed aside as the needle arm rotates between the two suture arms, the suture on the ventricular side can extend in a generally straight path between the suture penetration locations. This can help prevent unnecessary stress on the chordae tendineae, which would occur if the suture took a circuitous path around the chordae tendineae as it traveled from one suture penetration location to the next. Pulling the suture tight can pull the suture tight against the base of one or more chordae tendineae, which could damage the chordae tendineae.
用于施加结的示例性装置Exemplary Apparatus for Applying a Knot
本文所述的不同实施方案依赖于将一个或多个缝合线连接在一起。以下描述涉及用于连接缝合线的装置和方法。图117显示了结放置装置900的一个实施方案，结放置装置900可以用于向缝合线部分130施加结。结放置装置900可以包括手柄902和杆904，杆904从手柄向远侧伸出。手柄902可以包括从近端延伸至远端的长型管状体，并且可以包括促动器906和远端部分910。手柄902可以还包括仿形件908和弹簧912，弹簧912显示为其静止位置，其被置于仿形件908和端部910之间。促动器906可以是与仿形件908接触的拇指或手指按钮。可以通过胶、压入配合、注射制模或本领域技术人员已知的其他合适手段将端部910固定地附接至外部管914。中间管916可以同心地和可滑动地置于外部管914中。推杆918可以同心地和可滑动地置于中间管916内并固定地附接至仿形件908。应当理解，考虑到了结放置装置900未必包括中间管916；但是包括它可以提供一定益处。The various embodiments described herein rely on connecting one or more sutures together. The following description relates to devices and methods for connecting sutures. Figure 117 shows an embodiment of a knot placement device 900 that can be used to apply a knot to a suture portion 130. The knot placement device 900 can include a handle 902 and a rod 904 that extends distally from the handle. The handle 902 can include an elongated tubular body extending from a proximal end to a distal end and can include an actuator 906 and a distal portion 910. The handle 902 can also include a contour 908 and a spring 912, with the spring 912 shown in its resting position, positioned between the contour 908 and the end 910. The actuator 906 can be a thumb or finger button that contacts the contour 908. The end 910 can be fixedly attached to the outer tube 914 by glue, press-fit, injection molding, or other suitable means known to those skilled in the art. An intermediate tube 916 can be concentrically and slidably positioned within the outer tube 914. A push rod 918 can be concentrically and slidably disposed within the intermediate tube 916 and fixedly attached to the contour 908. It should be understood that it is contemplated that the knot placement device 900 need not include the intermediate tube 916; however, including it can provide certain benefits.
按压促动器906使仿形件908向远侧运动，压缩弹簧912，从而使推杆918运动。在运动一定需要的距离之后，仿形件908接合中间管916的近端，导致中间管916也向远侧运动。促动器906释放后，弹簧912扩张，从而使仿形件908和推杆918向近侧运动。在所示实施方案中，中间管916可以自由地在推杆918上滑动。Depressing actuator 906 moves contour 908 distally, compressing spring 912, thereby moving push rod 918. After moving a desired distance, contour 908 engages the proximal end of intermediate tube 916, causing intermediate tube 916 to also move distally. When actuator 906 is released, spring 912 expands, thereby moving contour 908 and push rod 918 proximally. In the illustrated embodiment, intermediate tube 916 is free to slide over push rod 918.
在一个实施方案中(未示出)，仿形件908可以在接触促动器906的表面上包括止动件。止动件可以向使用者提供推杆918、中间管916或两者的具体前进程度的信号。例如，止动件可以提供以下信号：推杆已前进足够远而将插头插入结的主体内，如下文所述。止动件还可以指示，向上运动(但不包括)至仿形件908接合中间管916的点。止动件的形状可以设定为能防止促动器906返回其初始位置。仿形件可以包括多个止动件，从而指示多个前进增量。为了使促动器返回其初始位置，促动器和仿形件可以包括一种机构，使得在促动器完全压下后，促动器可以自动返回其初始位置。或者，促动器可以具有锁定配置，在其中一个止动件或在完全压下的配置，并且手柄可以包括一种机构，通过该结构第二促动器可以用于释放仿形件和促动器而返回其初始位置。In one embodiment (not shown), the contour 908 may include a stop on the surface that contacts the actuator 906. The stop can signal to the user the specific degree of advancement of the push rod 918, the intermediate tube 916, or both. For example, the stop can signal that the push rod has advanced far enough to insert the plug into the body of the knot, as described below. The stop can also indicate upward movement up to (but not including) the point at which the contour 908 engages the intermediate tube 916. The stop can be shaped to prevent the actuator 906 from returning to its initial position. The contour can include multiple stops, thereby indicating multiple increments of advancement. To return the actuator to its initial position, the actuator and contour can include a mechanism that automatically returns the actuator to its initial position after the actuator is fully depressed. Alternatively, the actuator can have a locking configuration, with one stop or in the fully depressed configuration, and the handle can include a mechanism by which a second actuator can be used to release the contour and actuator to return to their initial positions.
在一个实施方案中(未示出)，中间管916可以包括键槽，外部管914、端部910或两者可以包括键。或者，中间管916可以包括键，外部管914、端部910或两者可以包括键槽。提供这样的键和键槽可以用于保持中间管916对准外部管。考虑到了其他实施方案来保持中间管的转动对准，例如相对于推动杆转动地固定中间管。提供这样的键和键槽还可以用于限制中间管916的滑动运动的范围。In one embodiment (not shown), the intermediate tube 916 can include a keyway and the outer tube 914, the end 910, or both can include a key. Alternatively, the intermediate tube 916 can include a key and the outer tube 914, the end 910, or both can include a keyway. Providing such a key and keyway can be used to maintain alignment of the intermediate tube 916 with the outer tubes. Other embodiments are contemplated to maintain rotational alignment of the intermediate tube, such as by rotationally securing the intermediate tube relative to the push rod. Providing such a key and keyway can also be used to limit the range of sliding motion of the intermediate tube 916.
如图118所示，包括结主体924和插头926的结可以被置于外部管914的远端中。在另一实施方案中，结主体可以包括防损伤尖端932。尖端932可以是圆形的，并且具有与外部管914大致相同的外径。尖端还可以包括平的过渡部934。尖端932可以与结主体924整体成形，或者可以单独附接。如图所示，尖端932可以具有孔936，孔936轴向伸出通过尖端，开口于结主体内部的腔。当如上文所述将结递送入患者中时，防损伤尖端防止对患者造成损伤。As shown in Figure 118, the knot comprising a knot body 924 and a plug 926 can be placed in the distal end of an outer tube 914. In another embodiment, the knot body can include a damage-resistant tip 932. The tip 932 can be circular and have an outer diameter roughly the same as that of the outer tube 914. The tip can also include a flat transition portion 934. The tip 932 can be integrally formed with the knot body 924, or can be attached separately. As shown in the figure, the tip 932 can have a hole 936, which extends axially through the tip and is open to the cavity inside the knot body. When the knot is delivered into the patient as described above, the damage-resistant tip prevents the patient from being damaged.
或者，结主体924和外部管914之间的配合不能将结主体924保持在外部管914中。结主体924可以位于外部管914的远端，并且可以稍微突出至外部管914的远端的远侧。插头926可以位于结主体924的近侧，并且可以可滑动地置于中间管916中，中间管916具有位于结主体的近侧的和推杆918的远侧的远端。插头926具有配置为能被插入结主体924的内腔的外部尺寸。中间管916的尺寸和位置可以设定为，使得其远端可以邻接结主体924。918. Alternatively, the fit between the knot body 924 and the outer tube 914 may not retain the knot body 924 within the outer tube 914. The knot body 924 may be located at the distal end of the outer tube 914 and may protrude slightly distal to the distal end of the outer tube 914. The plug 926 may be located proximal to the knot body 924 and may be slidably disposed within the intermediate tube 916, which has a distal end proximal to the knot body and distal to the push rod 918. The plug 926 has an outer dimension configured to be inserted into the lumen of the knot body 924. The intermediate tube 916 may be sized and positioned such that its distal end abuts the knot body 924.
如图118所示，外部管914可以在其远端附近包括侧孔920。中间管916可以包括槽(未示出)，槽从其远端向近侧伸出，形成C形截面。在槽的近端，可以提供尖锐的切割面来切割缝合线130，如下文所述。槽还可以与中间管的远端隔开，使得管的远端仍然在截面形成完整的环形。外部管914、中间管916和推杆918可以由任何合适的材料制成，包括但不限于金属、塑料以及金属和塑料的组合。As shown in Figure 118, outer tube 914 can include side hole 920 near its distal end. Intermediate tube 916 can include groove (not shown), and groove extends from its distal end to the proximal side, forming a C-shaped cross section. At the proximal end of the groove, a sharp cutting surface can be provided to cut suture 130, as described below. The groove can also be separated from the distal end of the intermediate tube so that the distal end of the tube still forms a complete ring in the cross section. Outer tube 914, intermediate tube 916 and push rod 918 can be made of any suitable material, including but not limited to metal, plastic and a combination of metal and plastic.
如图118所示，在预加载的配置中，结放置装置900可以包括穿线器928，穿线器928包括拉环(tab)931和成环的丝930，丝930通过外部管914中的侧孔920。丝930伸出通过位于中间管916中的槽122并通过结主体924，通过位于结主体924的远端的开口936离开。如下文所述，穿线器928可以用于将缝合线加载到结放置装置中。当结主体所提供的外部尺寸与外部管914的内壁相同或相似时，穿线器928还防止结主体924脱离放置装置900中。As shown in Figure 118, in the configuration of preload, knot placement device 900 can comprise threader 928, and threader 928 comprises draw ring (tab) 931 and looped silk 930, and silk 930 passes through the side hole 920 in the outer tube 914.Silk 930 stretches out by the groove 122 that is positioned at intermediate tube 916 and passes through knot body 924, leaves by the opening 936 of the far-end that is positioned at knot body 924.As described below, threader 928 can be used for suture being loaded into the knot placement device.When the external dimension that knot body provided was identical or similar with the inwall of outer tube 914, threader 928 also prevented knot body 924 from breaking away from placement device 900.
参考图118，结主体924可以大体上是管状的，并包括近端、远端以及纵轴。结主体924进一步限定了内腔，并且可以在其远端包括开口936。结主体可以具有大体上一致的内径和外径。或者，内径、外径或两者可以大体上沿着结主体的纵轴渐缩。或者，内径、外径或两者可以大体上沿着纵轴的一部分渐缩，并且可以在纵轴的一部分上具有大体上一致的内径，外径或两者。With reference to Figure 118, knot body 924 can be generally tubular and include a proximal end, a distal end and a longitudinal axis. Knot body 924 further defines an inner cavity and can include an opening 936 at its distal end. Knot body can have a generally consistent inner diameter and outer diameter. Alternatively, the inner diameter, outer diameter or both can be tapered generally along the longitudinal axis of the knot body. Alternatively, the inner diameter, outer diameter or both can be tapered generally along a portion of the longitudinal axis and can have a generally consistent inner diameter, outer diameter or both on a portion of the longitudinal axis.
在一些实施方案中，结主体的远端的开口936可以具有相对于结主体924的内腔减小的直径。结主体还可以在近端包括开口。在一些实施方案中，近端的开口可以具有相对于结主体924的内腔减小的直径。结主体还可以包括凸起938，凸起938从结主体924的内表面朝向纵轴伸出。凸起938可以被形成为如图所示的环或形成为螺旋、尖峰、隆起或其他合适的结构或结构组合。In some embodiments, the opening 936 at the distal end of the knot body can have a diameter that is reduced relative to the lumen of the knot body 924. The knot body can also include an opening at the proximal end. In some embodiments, the opening at the proximal end can have a diameter that is reduced relative to the lumen of the knot body 924. The knot body can also include a protrusion 938 that extends from the inner surface of the knot body 924 toward the longitudinal axis. The protrusion 938 can be formed into a ring as shown or into a spiral, a spike, a ridge, or other suitable structure or combination of structures.
参照图118，在一个实施方案中，结主体924可以位于外部管914中的插头926的远侧。插头的尺寸可以被设定为能插入结主体924的内腔中，并且可以具有渐缩形配置。或者，插头926可以在其长度的主要部分具有一致的截面，具有渐缩的、倒棱的或圆形的远端，以便于插入结主体924。插头926的外部尺寸可以稍大于结主体924的腔的内部尺寸，使得当插头被插入腔时，在两者之间可以提供相对稳固的配合。结主体中的凸起938还便于相对固定。插头926还可以包括用于容纳凸起938的压痕(未示出)，从而将插头926更稳定地固定于结主体924中。还考虑到了其他实施方案，其中凸起可以形成在插头926上，结主体924的内腔中形成或不形成压痕。还考虑到，在一些实施方案中，插头926和结主体924可以分别包括凸起和压痕。在某些实施方案中，将插头926插入结主体924可以使结主体924轻微扩张。结和结主体可以由任何合适的弹性材料制成，并且在一个实施方案中，可以与缝合线由相同材料制成，更优选为聚丙烯。Referring to Figure 118, in one embodiment, the knot body 924 can be located distally of the plug 926 in the outer tube 914. The plug can be sized to be inserted into the inner cavity of the knot body 924 and can have a tapered configuration. Alternatively, the plug 926 can have a uniform cross-section along the majority of its length, with a tapered, chamfered, or rounded distal end to facilitate insertion into the knot body 924. The outer dimensions of the plug 926 can be slightly larger than the inner dimensions of the cavity of the knot body 924, so that when the plug is inserted into the cavity, a relatively stable fit can be provided between the two. The protrusion 938 in the knot body also facilitates relative fixation. The plug 926 can also include an indentation (not shown) for accommodating the protrusion 938, thereby more stably securing the plug 926 to the knot body 924. Other embodiments are also contemplated, in which the protrusion can be formed on the plug 926, with or without the indentation formed in the inner cavity of the knot body 924. It is also contemplated that in some embodiments, the plug 926 and the knot body 924 can include a protrusion and an indentation, respectively. In some embodiments, inserting plug 926 into knot body 924 may slightly expand knot body 924. The knot and knot body may be made of any suitable elastic material, and in one embodiment, may be made of the same material as the suture, more preferably polypropylene.
图118-119示出利用上文所述的结放置装置900放置结的一个实施方案。一对缝合线端部130可以通过穿线器928的环930。穿线器可以被预加载在如上文所述的结放置装置900中。可以向近侧拉动穿线器928的拉环931，从而将缝合线130置于装置中。缝合线130可以通过手或其他方式保持张力，同时装置900可以前进，直至结主体924或杆904接触至少一个组织部分。可以按压促动器906，以使推杆918前进，从而使插头926向远侧进入结主体924并将缝合线130捕获在插头926和结主体924之间。可以进一步按压促动器，直至仿形件908接触中间管916的近端，导致中间管916接触结主体924并将结从杆904逐出。中间管916的前进还可以使切割面在缝合线130伸出开口的位置割断缝合线130。然后，可以取出结放置装置，留下结抵靠组织部分。Figures 118-119 illustrate an embodiment of a knot placement device 900 utilizing the knot placement device described above. A pair of suture ends 130 can pass through the loop 930 of the threader 928. The threader can be preloaded in the knot placement device 900 as described above. The pull ring 931 of the threader 928 can be pulled proximally to place the suture 130 in the device. The suture 130 can be held in tension by hand or otherwise while the device 900 advances until the knot body 924 or the rod 904 contacts at least one tissue portion. The actuator 906 can be pressed to advance the push rod 918, thereby causing the plug 926 to distally enter the knot body 924 and capture the suture 130 between the plug 926 and the knot body 924. The actuator can be further pressed until the proximal end of the contour member 908 contacts the intermediate tube 916, causing the intermediate tube 916 to contact the knot body 924 and eject the knot from the rod 904. The advancement of the intermediate tube 916 can also cause the cutting surface to sever the suture 130 at the location where the suture 130 extends out of the opening. The knot placement device can then be removed, leaving the knot against the tissue portion.
在一个实施方案中，可以将结从杆904逐出，同时不割断缝合线130。例如，在切割面到达缝合线130之前，可以逐出结。在另一实施方案中，可以不提供中间管，并且可以手动切割缝合线。In one embodiment, the knot can be ejected from the rod 904 without severing the suture 130. For example, the knot can be ejected before the cutting surface reaches the suture 130. In another embodiment, no intermediate tube can be provided, and the suture can be cut manually.
在包括中间管的实施方案中，装置900可以被配置为，使得外部管914、中间管916以及推杆918的远端大体上相对于彼此齐平，并且可以相对地保持在位置。可以例如通过按压促动器保持该位置，直至其停止在仿形件908中的止动件。止动件可以为使用者发出插头926已被插入结主体924，但是缝合线130还未被切割的信号。此时，利用杆的远端表面，放置装置可以用于进一步使结前进抵靠组织部分。可以进一步按压促动器而使推杆918和中间管916前进以切断缝合线130。In the embodiment that comprises intermediate pipe, device 900 can be configured to, makes the far-end of outer tube 914, intermediate pipe 916 and push rod 918 flush with respect to each other substantially, and can remain on position relatively.Can for example keep this position by pressing actuator, until it stops at the stopper in the contoured member 908.The stopper can send plug 926 and be inserted into knot main body 924 for the user, but suture 130 is not also cut signal.At this moment, utilize the distal end surface of rod, placement device can be used for further making knot advance against tissue portion.Can further press actuator and make push rod 918 and intermediate pipe 916 advance to cut off suture 130.
促动器906和仿形件908还可以提供有防止促动器906返回其初始位置的锁定机构。更多细节提供在2006年3月30日公开的美国专利申请公开2006/0069397，通过引用将其整体并入本文。这样的实施方案在以下方面可以是有利的，保持推杆与外部管的远端齐平，从而提供可以用于进一步使结前进和定位抵靠组织部分的平面。The actuator 906 and contour 908 may also be provided with a locking mechanism that prevents the actuator 906 from returning to its initial position. Further details are provided in U.S. Patent Application Publication No. 2006/0069397, published on March 30, 2006, which is incorporated herein by reference in its entirety. Such an embodiment may be advantageous in that it maintains the push rod flush with the distal end of the outer tube, thereby providing a flat surface that can be used to further advance and position the knot against the tissue portion.
应当理解，可以考虑不使用中间管、但仍能切断缝合线的其他实施方案。例如，可以为推杆提供具有不同直径的部分。远侧的、较小的直径的尺寸可以设定为能接合插头926，从而将插头推入结主体924。可以在推杆上提供近侧的、较大的直径，其可以在较大的和较小的直径区段之间的过渡部包括尖锐的表面。当推杆的较小部分将插头926推入结主体924时，推杆的较大的部分可以接合结主体924，从而将结推出放置装置，同时推杆上的尖锐的表面可以切断缝合线。It should be understood that other embodiments that do not use an intermediate tube but still can cut sutures can be considered. For example, the push rod can be provided with sections having different diameters. The distal, smaller diameter can be sized to engage the plug 926, thereby pushing the plug into the knot body 924. A proximal, larger diameter can be provided on the push rod, which can include a sharp surface at the transition between the larger and smaller diameter sections. When the smaller portion of the push rod pushes the plug 926 into the knot body 924, the larger portion of the push rod can engage the knot body 924, thereby pushing the knot out of the placement device, and the sharp surface on the push rod can cut the suture.
在上文所述的实施方案中，当如上文所述的结主体924和插头926被牢固地保持在一起时，延伸通过结主体的内腔的缝合线部分会被固定在其中，形成结。应当理解，许多其他实施方案可以用来形成结，包括用于结主体和插头的各种其他形状和配置，以及仅一个部件可以用于提供相对于缝合线的固定的实施方案。还应当理解，在结可以包括结主体和插头的那些实施方案中，插头可以位于杆中、结主体的近侧，或结主体可以位于杆中、插头的近侧。In the embodiment described above, when the knot body 924 and plug 926 as described above are securely held together, the portion of the suture extending through the lumen of the knot body is secured therein, forming a knot. It should be understood that many other embodiments can be used to form the knot, including various other shapes and configurations for the knot body and plug, as well as embodiments in which only one component can be used to provide fixation relative to the suture. It should also be understood that in those embodiments in which the knot can include a knot body and a plug, the plug can be located in the shaft, proximal to the knot body, or the knot body can be located in the shaft, proximal to the plug.
心脏中的操作完成后，可以闭合已经打开的用于提供缝合装置进入体内的的进入途径(例如，经心尖开口)的任何途径。关于闭合经心尖开口的其他细节提供在发明名称为METHODS AND APPARATUSES FOR SUTURING OF CARDIAC OPENINGS(缝合心脏开口的方法和装置)的美国专利公开2011/0190793A1，通过引用的方式将上述文献整体并入本文并作为说明书的一部分。After the operation in the heart is completed, any access route that has been opened to provide access to the body for the suturing device (e.g., a transapical opening) can be closed. Additional details about closing the transapical opening are provided in U.S. Patent Publication No. 2011/0190793A1, entitled METHODS AND APPARATUSES FOR SUTURING OF CARDIAC OPENINGS, which is incorporated herein by reference in its entirety and made a part of this specification.
虽然上述优选实施方案的描述已经展示、描述并指出的本发明的基本新特征，应当理解，在不脱离本发明的实质的条件下，本领域技术人员可以对所述的装置及其使用的细节的形式中进行各种缺省、替换以及改变。例如，尽管结合缝合患者心脏的瓣描述了缝合装置，应当设想到该缝合装置可用于闭合或减小体内多种其他组织开口、腔、中空器官或天然的或手术制造的通道。该缝合装置可以具有任何合适数量的臂，例如2个或4个或更多个，以及任何给定的臂可以具有一个或多个缝合线扣或开口。Although the above description of the preferred embodiments has shown, described and pointed out the basic novel features of the present invention, it should be understood that various omissions, substitutions and changes in the form of the details of the device and its use can be made by those skilled in the art without departing from the essence of the present invention. For example, although the suturing device is described in conjunction with suturing a valve of a patient's heart, it is contemplated that the suturing device can be used to close or reduce a variety of other tissue openings, cavities, hollow organs or natural or surgically created passages in the body. The suturing device can have any suitable number of arms, such as 2 or 4 or more, and any given arm can have one or more suture buckles or openings.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US61/476,236 | 2011-04-15 |
| Publication Number | Publication Date |
|---|---|
| HK1234301A HK1234301A (en) | 2018-02-15 |
| HK1234301A1 HK1234301A1 (en) | 2018-02-15 |
| HK1234301Btrue HK1234301B (en) | 2021-01-15 |
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