技术领域Technical Field
本发明涉及一种用于植入身体软组织中以保持线的软组织锚固系统。The present invention relates to a soft tissue anchoring system for implantation in soft tissue of the body to hold a wire.
背景技术Background Art
腱索是将乳头肌与心脏中的三尖瓣和二尖瓣连接起来的索状肌腱。瓣膜由瓣叶组成，瓣叶随着心脏的跳动而打开和关闭，以控制心脏内的血流和血压。The chordae tendineae are cord-like tendons that connect the papillary muscles to the tricuspid and mitral valves in the heart. The valves are made up of leaflets that open and close as the heart beats to control blood flow and blood pressure within the heart.
二尖瓣疾病对心脏外科医生和心脏病专家来说是一个重大挑战。二尖瓣反流已成为发达国家中二尖瓣的主要病理生理状况。反流的最重要原因之一是二尖瓣瓣叶之一脱垂。需要修复的病理异常是腱索、瓣叶或其他相关结构的破裂或其他退行性变化。当腱索保持完整时，二尖瓣瓣叶会同步打开和关闭，并防止瓣膜的泄漏。正常腱索可能会急性破裂，导致急性失代偿，即心力衰竭。这通常会导致需要快速干预的紧急情况。腱索损伤也可能以较慢的速度发生，包括由于退行性过程而破裂或伸长，从而导致二尖瓣出现泄漏或反流。Mitral valve disease presents a major challenge for cardiac surgeons and cardiologists. Mitral regurgitation has become the leading pathophysiological condition of the mitral valve in developed countries. One of the most important causes of regurgitation is prolapse of one of the mitral valve leaflets. The pathological abnormality that requires repair is a rupture or other degenerative changes in the chordae tendineae, leaflets, or other associated structures. When the chordae tendineae remain intact, the mitral valve leaflets open and close synchronously and prevent leakage of the valve. Normal chordae tendineae may rupture acutely, resulting in acute decompensation, i.e., heart failure. This often results in an emergency situation that requires rapid intervention. Chordal injury can also occur at a slower rate, including rupture or elongation due to a degenerative process, resulting in leakage or regurgitation in the mitral valve.
二尖瓣的外科修复已变得相对标准化，其使用切除脱垂的瓣叶和/或植入新的人造腱索线来控制瓣叶运动。此外，经常放置二尖瓣环以缩小二尖瓣环的尺寸。手术更换破裂或拉长的腱索对于消除或最大限度地减少二尖瓣反流非常有效。目前，该手术采用心内直视手术技术来执行。这需要使用心肺分流术和心脏骤停。这种外科手术方法虽然效果很好，但是一种高度侵入性的手术，可能导致严重的并发症、长期住院和大量费用。因此，侵入性较小的方法会更好。同样，侵入性较小的方法对于治疗三尖瓣也将是更好的选择，三尖瓣与二尖瓣类似，也可能患有三尖瓣疾病。Surgical repair of the mitral valve has become relatively standardized using the removal of the prolapsed leaflets and/or the implantation of new artificial chordae to control leaflet motion. In addition, a mitral ring is often placed to reduce the size of the mitral annulus. Surgical replacement of ruptured or elongated chordae is very effective in eliminating or minimizing mitral regurgitation. Currently, this procedure is performed using open-heart surgical techniques. This requires the use of cardiopulmonary bypass and cardiac arrest. This surgical approach, while highly effective, is a highly invasive procedure that can result in significant complications, prolonged hospital stays, and substantial expense. Therefore, a less invasive approach would be better. Similarly, a less invasive approach would also be a better option for treating the tricuspid valve, which, like the mitral valve, can also suffer from tricuspid valve disease.
二尖瓣瓣叶索的插入是通过使用微创手术方法从心脏顶端进入心脏进行的。该技术由Neochord有限公司开发，例如在WO2012/167120中进行了描述，但仍需要手术切口，并且索未被插入它们通常应当固定在其中的乳头肌中。Insertion of the mitral valve leaflet cords is performed by entering the heart from the apex of the heart using a minimally invasive surgical approach. This technique was developed by Neochord Ltd and is described, for example, in WO 2012/167120, but still requires a surgical incision and the cords are not inserted into the papillary muscles where they would normally be anchored.
WO2008/101113描述了用于修复心脏的系统的另一个示例，包括植入人造腱索线。在所描述的方法中，锚可以附接到乳头肌，并通过人造腱索线、缝合线和夹连接到二尖瓣的瓣叶。夹允许调整人造腱索线的长度。植入乳突锚和缝合线并将它们连接在一起需要复杂的多阶段过程。乳突锚由记忆金属(例如镍钛合金)制成，具有“花”形，带有尖锐的“花瓣”，用于将锚钩到身体组织上。花形被压扁成管形并保持在插入心脏的管中。然后将管和锚压靠在乳头肌上，并将锚推出管，使得花瓣刺穿肌肉并向外折叠穿过肌肉，从而将锚牢固地联接至肌肉组织。在随后的外科手术中，可将人造腱索线附接到锚上。然后在下一步中，将缝合线附接到瓣叶上，并通过夹将该缝合线连接到腱索上。通过将真空端口定位在瓣叶附近并将其拉入真空端口(可在此处刺穿)来将缝合线连接到瓣叶上。WO2008/101113 describes another example of a system for repairing the heart, including implanting an artificial chord. In the described method, the anchor can be attached to the papillary muscle and connected to the leaflet of the mitral valve by an artificial chord, a suture and a clip. The clip allows the length of the artificial chord to be adjusted. Implanting the mastoid anchor and suture and connecting them together requires a complex multi-stage process. The mastoid anchor is made of a memory metal (e.g., nickel-titanium alloy) and has a "flower" shape with sharp "petals" for hooking the anchor to body tissue. The flower shape is flattened into a tubular shape and retained in a tube inserted into the heart. The tube and anchor are then pressed against the papillary muscle, and the anchor is pushed out of the tube so that the petals pierce the muscle and fold outward through the muscle, thereby firmly connecting the anchor to the muscle tissue. In a subsequent surgical procedure, the artificial chord can be attached to the anchor. Then in the next step, the suture is attached to the leaflet and the suture is connected to the chord by a clip. The suture is attached to the leaflets by positioning the vacuum port near the leaflets and pulling it into the vacuum port where it can be pierced.
可以理解的是，这种技术虽然避免了心脏直视手术，但仍需要一系列相对复杂的步骤。所需步骤的数量增加了风险。此外，该装置的复杂性意味着植入体内的部件有松动的风险，并通过栓塞伤害患者。特别地，夹可能会从锚上松动。人们还认为，如所提议的那样，使用带有附加的夹的缝合线可能无法有效地修复心脏瓣膜，因为它不能近似地模拟天然索。Understandably, this technique, while avoiding open heart surgery, still requires a relatively complex series of steps. The number of steps required increases the risk. Furthermore, the complexity of the device means there is a risk that the components implanted in the body could become loose and harm the patient via embolism. In particular, the clip could become loose from the anchor. It is also believed that using a suture with an attached clip, as proposed, may not be effective in repairing a heart valve because it does not closely mimic the natural cord.
在早期的专利申请WO2016/042022中，本申请人公开了一种用于植入人造腱索线以修复心脏瓣膜的导管装置。WO2016/042022的导管装置包括用于夹持心脏瓣膜的瓣叶的机械夹持装置，其中，瓣叶锚容纳在夹持器中。瓣叶锚可以由柔性材料(例如镍钛合金)形成，在展开构型下具有抓钩形状，并且能够弹性变形为折叠构型，例如，当被限制在夹持装置中的瓣叶锚定通道内时。当瓣叶锚处于折叠构型时，钩被拉直。当瓣叶被夹持装置夹持时，瓣叶锚可以被推出夹持器以驱动钩穿过瓣叶，同时它们弹性返回到展开构型，从而将瓣叶锚固定在瓣叶中。In an earlier patent application WO2016/042022, the applicant disclosed a catheter device for implanting artificial chords to repair heart valves. The catheter device of WO2016/042022 includes a mechanical clamping device for clamping the leaflets of a heart valve, wherein the leaflet anchor is housed in a clamp. The leaflet anchor can be formed of a flexible material (e.g., nickel-titanium alloy), has a grabber shape in an expanded configuration, and can be elastically deformed into a folded configuration, for example, when confined in a leaflet anchoring channel in the clamping device. When the leaflet anchor is in a folded configuration, the hook is straightened. When the leaflet is clamped by the clamping device, the leaflet anchor can be pushed out of the clamp to drive the hook through the leaflet, while they elastically return to the expanded configuration, thereby fixing the leaflet anchor in the leaflet.
WO2016/042022中描述的装置也使用具有大致相似的可折叠钩布置的乳突锚。乳突锚以折叠构型保持在导管装置的管内，并且可以被推出管外，同时钩被驱动到心壁中，同时它们弹性地返回到展开构型，从而将乳突锚固定到肌肉上。乳突锚包括锁定环，该锁定环用作锁定机构，用于在未施加力时夹紧人造腱索线。锁定环可以弹性变形，以将线从锁定机构释放，以调整腱索线的长度。The device described in WO2016/042022 also uses a mastoid anchor with a substantially similar foldable hook arrangement. The mastoid anchor is held within the tube of the catheter device in a folded configuration and can be pushed out of the tube while the hooks are driven into the heart wall while they elastically return to the expanded configuration, thereby securing the mastoid anchor to the muscle. The mastoid anchor includes a locking ring that acts as a locking mechanism for clamping the artificial chord line when no force is applied. The locking ring can be elastically deformed to release the line from the locking mechanism to adjust the length of the chord line.
在另一项早期专利申请WO2020/109588中，本申请人披露了对WO2016/042022中披露的导管装置的进一步改进，以及与之相关的新发展。改进的一个领域集中在瓣叶锚的设计上。其中披露的瓣叶锚被设计用于增加瓣叶锚在植入时与瓣叶接触的表面积，并尽量减少瓣叶在植入过程中受到的创伤。In another earlier patent application WO2020/109588, the applicant disclosed further improvements to the catheter device disclosed in WO2016/042022, as well as new developments related thereto. One area of improvement focuses on the design of the leaflet anchor. The leaflet anchor disclosed therein is designed to increase the surface area of the leaflet anchor in contact with the leaflet during implantation and to minimize trauma to the leaflet during implantation.
其它锚固系统也可从例如US2009/0076547中得知，其公开了一种组织锚，包括具有折叠部分的单个细长条带。细长条带从穿过组织的管状构件递送。缝合线延伸穿过细长条带并绕回。当缝合线施加拉力时，细长条带围绕组织折叠。Other anchoring systems are also known from, for example, US2009/0076547, which discloses a tissue anchor comprising a single elongated strip having a folded portion. The elongated strip is delivered from a tubular member that passes through the tissue. A suture extends through the elongated strip and wraps back. When tension is applied by the suture, the elongated strip folds around the tissue.
虽然WO2016/042022和WO2020/109588的装置在该领域取得了重大进展，但人们发现进一步的改进设计可能会更有优势。本公开涉及在各个方面基于WO2016/042022和WO2020/109588中公开的装置的设计的新特征。Although the devices of WO2016/042022 and WO2020/109588 have made significant progress in this field, it has been found that further improved designs may be more advantageous. The present disclosure relates to novel features based on the designs of the devices disclosed in WO2016/042022 and WO2020/109588 in various aspects.
发明内容Summary of the invention
本发明的目的是提供一种用于植入身体软组织、更优选地是心脏组织中的改进的锚固系统。It is an object of the present invention to provide an improved anchoring system for implantation in soft body tissue, more preferably cardiac tissue.
根据本发明，在此提供了如第一方面中所述的软组织锚固系统、如第四和第五方面中所述的导管装置、如第六方面中讨论的将软组织锚固系统植入身体组织的方法以及如第七方面中讨论的制造软组织锚固系统的方法。According to the present invention, there is provided a soft tissue anchoring system as described in the first aspect, a catheter device as described in the fourth and fifth aspects, a method of implanting a soft tissue anchoring system into body tissue as discussed in the sixth aspect, and a method of manufacturing a soft tissue anchoring system as discussed in the seventh aspect.
从本发明的第一方面来看，提供了一种用于植入身体软组织中以固定人造线的软组织锚固系统，该锚固系统包括：线；和管状盖构件；其中，线的一端固定到管状盖构件并从其中央部分延伸，使得在使用中，管状盖构件被配置为，当被植入身体软组织中并且当线在沿远离组织的表面的方向穿过组织时在线的拉力作用下，该管状盖构件在与身体软组织的表面平行的平面中延伸；并且其中，管状盖构件包括开口，该开口被配置为接收丝线引导构件，用于使管状盖构件在植入期间穿过身体软组织。From the first aspect of the present invention, there is provided a soft tissue anchoring system for implanting in soft body tissue to fix an artificial wire, the anchoring system comprising: a wire; and a tubular cover member; wherein one end of the wire is fixed to the tubular cover member and extends from a central portion thereof, so that in use, the tubular cover member is configured to, when implanted in the soft body tissue and when the wire passes through the tissue in a direction away from the surface of the tissue, under the action of the tension of the wire, the tubular cover member extends in a plane parallel to the surface of the soft body tissue; and wherein the tubular cover member comprises an opening configured to receive a wire guide member for allowing the tubular cover member to pass through the soft body tissue during implantation.
通过提供包括被构造成接收丝线引导构件以用于在植入期间使管状盖构件穿过身体软组织的开口的管状盖构件，可以操纵管状盖构件，使得其能够以窄的构造穿过身体软组织。例如，丝线引导构件可以在插入的方向上推动管状盖构件，使得其以窄的构造穿过身体软组织。换句话说，开口可以便于丝线引导构件和管状盖构件之间的接合，使得管状盖构件能够在端部被保持，然后沿平行于其轴线的方向穿过身体软组织。以这种方式使管状盖构件穿过身体软组织可以最小化软组织锚固系统植入部位处的创伤。By providing a tubular cover member including an opening configured to receive a wire guide member for passing the tubular cover member through body soft tissue during implantation, the tubular cover member can be manipulated so that it can pass through body soft tissue with a narrow structure. For example, the wire guide member can push the tubular cover member in the direction of insertion so that it passes through body soft tissue with a narrow structure. In other words, the opening can facilitate the engagement between the wire guide member and the tubular cover member so that the tubular cover member can be held at the end and then passed through body soft tissue in a direction parallel to its axis. Passing the tubular cover member through body soft tissue in this way can minimize the trauma at the soft tissue anchoring system implantation site.
此外，通过使用丝线引导构件来促使管状盖构件穿过身体组织，而不是使用穿过软组织锚部署位置处的身体组织的递送导管或针，管状盖构件所穿过的身体组织中的孔不需要与针或包含软组织锚固系统的其他导管穿过所需的孔一样大。也就是说，身体组织中的植入部位(即植入期间形成的开口)的尺寸仅受管状盖构件的几何形状或穿过身体软组织的软组织锚固系统的其他部分的限制。相比之下，通过针植入所需的开口的尺寸将总是受针的尺寸限制，针的尺寸始终大于要部署的构件。这可以减少植入部位处的创伤。Furthermore, by using a wire guide member to cause the tubular cover member to pass through body tissue, rather than using a delivery catheter or needle that passes through body tissue at the soft tissue anchor deployment location, the hole in the body tissue through which the tubular cover member passes does not need to be as large as the hole required for the needle or other catheter containing the soft tissue anchor system to pass through. That is, the size of the implantation site in the body tissue (i.e., the opening formed during implantation) is limited only by the geometry of the tubular cover member or other parts of the soft tissue anchor system that pass through the body soft tissue. In contrast, the size of the opening required for implantation by a needle will always be limited by the size of the needle, which is always larger than the member to be deployed. This can reduce trauma at the implantation site.
一旦管状盖构件穿过身体软组织，可以撤回丝线引导构件。在使用中，当通过穿过身体软组织(管状盖构件从此处穿过身体软组织)的线施加拉力时，管状盖构件被拉靠身体软组织，使得管状盖构件在与身体软组织平行的平面中延伸。然后，线可以延伸穿过身体软组织，管状盖构件以最大的表面积接触身体软组织，以防止管状盖构件被从植入部位拉回。Once the tubular cover member passes through the body soft tissue, the wire guide member can be withdrawn. In use, when a pulling force is applied by the wire passing through the body soft tissue (the tubular cover member passes through the body soft tissue from here), the tubular cover member is pulled against the body soft tissue so that the tubular cover member extends in a plane parallel to the body soft tissue. Then, the wire can be extended through the body soft tissue, and the tubular cover member contacts the body soft tissue with the largest surface area to prevent the tubular cover member from being pulled back from the implantation site.
因此，该方面的软组织锚固系统可植入身体软组织中，使得人造腱索线通过管状盖构件和身体软组织之间产生的接触力固定到身体软组织，由此使得植入部位的尺寸最小化，从而最小化植入过程中产生的任何创伤。Therefore, the soft tissue anchoring system of this aspect can be implanted in the soft tissue of the body so that the artificial tendon cord is fixed to the soft tissue of the body through the contact force generated between the tubular cover member and the soft tissue of the body, thereby minimizing the size of the implantation site and thus minimizing any trauma generated during the implantation process.
因此，提供了一种布置，其中，当丝线引导构件与管状盖构件接合时，管状盖构件将伸直并与线共线地延伸。这可以有助于将管状盖构件植入身体软组织中。当线随后受到力时，由于其居中地与管状盖构件固定，线可以使管状盖构件转动以与身体组织的表面平行。这可以有助于将管状盖构件固定到身体软组织，因为在拉力作用下，管状盖构件将被转动而以“T”构型垂直于线，该线垂直于身体组织的表面，并且管状盖构件的长度平行于身体组织的表面，从而防止管状盖构件穿过身体软组织的移动(类似于国库标签在使用中保持固定的方式)。Thus, an arrangement is provided wherein when the wire guide member engages the tubular cover member, the tubular cover member will straighten and extend co-linearly with the wire. This can assist in implanting the tubular cover member into soft body tissue. When the wire is subsequently subjected to a force, the wire can cause the tubular cover member to rotate parallel to the surface of the body tissue due to its central fixation to the tubular cover member. This can assist in securing the tubular cover member to the soft body tissue because under tension the tubular cover member will be rotated perpendicular to the wire in a "T" configuration, the wire being perpendicular to the surface of the body tissue and the length of the tubular cover member being parallel to the surface of the body tissue, thereby preventing movement of the tubular cover member through the soft body tissue (similar to the way a treasury tag remains fixed during use).
鉴于管状盖构件与线的组合呈“T”形部署，因此可将其视为“T形杆”锚。Given that the combination of the tubular cover member and the wire is deployed in a "T" shape, it can be considered a "T-bar" anchor.
管状盖构件可以是细长的管状体，包括用于接收丝线引导构件的空心。开口/空心可以完全沿着管状盖构件的整个长度延伸，或者可以替代地包括盲开口/空心。The tubular cover member may be an elongated tubular body comprising a hollow for receiving the wire guiding member. The opening/hollow may extend completely along the entire length of the tubular cover member, or may alternatively comprise a blind opening/hollow.
管状盖构件可以包括第一端、远离第一端的第二端以及在第一端和第二端之间延伸的侧壁。开口可位于管状盖构件的第一端处。管状盖构件的第二端可限定管状盖构件的末端，该末端被配置成用于插入身体软组织中。The tubular cover member may include a first end, a second end distal to the first end, and a sidewall extending between the first end and the second end. The opening may be located at the first end of the tubular cover member. The second end of the tubular cover member may define a distal end of the tubular cover member configured to be inserted into soft body tissue.
管状盖构件的中央部分可以被认为是管状盖构件的位于管状盖构件的几何中心(即，沿管状盖构件的纵向轴线的中心点)周围的部分，该部分包括：小于管状盖构件的长度的30％；小于管状盖构件的长度的40％；小于管状盖构件的长度的50％；或小于管状盖构件的长度的60％。管状盖构件的中央部分可被认为包括管状盖构件的长度的“中间三分之一”。换句话说，管状盖构件的中央部分可包括管状盖构件上的比第一端或第二端更靠近管状盖构件的几何中心的任意点。The central portion of the tubular cover member can be considered to be the portion of the tubular cover member located around the geometric center of the tubular cover member (i.e., the center point along the longitudinal axis of the tubular cover member) that includes: less than 30% of the length of the tubular cover member; less than 40% of the length of the tubular cover member; less than 50% of the length of the tubular cover member; or less than 60% of the length of the tubular cover member. The central portion of the tubular cover member can be considered to include the "middle third" of the length of the tubular cover member. In other words, the central portion of the tubular cover member can include any point on the tubular cover member that is closer to the geometric center of the tubular cover member than the first end or the second end.
管状盖构件可以由能够保持其形状的适当的刚性生物相容性材料制成，例如不锈钢、钛、工程塑料或镍钛诺。The tubular cover member may be made of a suitably rigid biocompatible material capable of retaining its shape, such as stainless steel, titanium, engineered plastics, or nitinol.
所述线可被认为是拉伸线，因为在使用中，在植入时，该线向管状盖构件施加拉力。The wire may be considered a stretch wire because, in use, upon implantation, the wire applies a tensile force to the tubular cover member.
线可以由缝合材料形成。线可以是人造线。或者，线可以通过任何合适的紧固装置(例如，结或环形接合)固定到人造线上。The thread may be formed of suture material. The thread may be an artificial thread. Alternatively, the thread may be secured to an artificial thread by any suitable fastening means (e.g., a knot or annular joint).
如上所述，线的一端固定至管状盖构件，并且线从管状盖构件的中央部分延伸。使得线从管状盖构件延伸的点沿着管状盖构件的中央部分定位可以提供稳定的布置，以在植入时保持“T”形构型。As described above, one end of the wire is fixed to the tubular cover member and the wire extends from the central portion of the tubular cover member. Positioning the point where the wire extends from the tubular cover member along the central portion of the tubular cover member can provide a stable arrangement to maintain a "T" configuration when implanted.
在一些示例中，该线可以基本上居中地延伸，即，基本上从管状盖构件的中心居中地延伸(例如，与管状盖构件的几何中心一致)。In some examples, the line can extend substantially centrally, ie, substantially centrally from the center of the tubular cover member (eg, coincident with the geometric center of the tubular cover member).
在其它示例中，该线可以不对称地延伸，并且因此可以从沿着管状盖构件的一点向着管状盖构件的第一端或第二端延伸(但仍在管状盖部分的中央部分内)。In other examples, the line may extend asymmetrically, and thus may extend from a point along the tubular cover member toward the first end or the second end of the tubular cover member (but still within the central portion of the tubular cover portion).
例如，非对称布置可将线从管状盖构件延伸处的点定位的远离开口(即朝向管状盖构件的末端)。使线从接近管状盖构件的末端的点延伸可便于对管状盖构件施加扭矩以将其置于“T”形构型中。然而，在其他优选示例中，线从管状盖构件延伸的点可靠近管状盖构件的开口(即，比接近末端更靠近管状盖构件的开口)。使线从接近管状盖构件的开口的点延伸可更好地分配当管状盖构件在被植入且在线的拉力下在与身体组织的表面平行的平面中延伸时，由管状盖构件施加的接触力。越靠近其末端，端盖可具有越小的投影面积(例如由于末端的锥度和/或斜面)，并且越靠近开口，管状盖构件可具有越大的投影面积(例如由于缺乏锥度/管状盖构件朝向开口变得较宽)。因此，将线从管状盖构件延伸处的点布置成靠近开口可以使得，当管状盖构件在与身体组织的表面平行的平面内延伸时，由管状盖构件的轮廓施加的接触力的分布更加均衡。For example, an asymmetric arrangement may position the point where the line extends from the tubular cover member away from the opening (i.e., toward the end of the tubular cover member). Extending the line from a point near the end of the tubular cover member may facilitate applying torque to the tubular cover member to place it in a "T" configuration. However, in other preferred examples, the point where the line extends from the tubular cover member may be close to the opening of the tubular cover member (i.e., closer to the opening of the tubular cover member than near the end). Extending the line from a point near the opening of the tubular cover member may better distribute the contact force applied by the tubular cover member when the tubular cover member is implanted and extends in a plane parallel to the surface of the body tissue under the tension of the line. The closer to its end, the end cap may have a smaller projected area (e.g., due to the taper and/or bevel of the end), and the closer to the opening, the tubular cover member may have a larger projected area (e.g., due to the lack of taper/the tubular cover member becomes wider toward the opening). Thus, arranging the point where the line extends from the tubular cover member close to the opening may provide a more even distribution of contact forces applied by the profile of the tubular cover member when the tubular cover member extends in a plane parallel to the surface of body tissue.
因此，如上所述的，所述线可以从其固定到的管状盖构件的中央部分：基本上在管状盖构件的中心处；朝向管状盖构件的第一端；或者朝向管状盖构件的第二端而延伸。Thus, as described above, the wire may extend from a central portion of the tubular cover member to which it is secured: substantially at the center of the tubular cover member; towards the first end of the tubular cover member; or towards the second end of the tubular cover member.
线的一端固定到管状盖部分的方式可以覆盖管状盖构件的一定长度。例如，线的一端的一定长度可以周向地缠绕在管状盖构件或其一部分周围，并且该长度的线还沿着管状盖构件的轴向长度延伸(即以螺旋或盘绕的方式)。从管状盖构件延伸的线可以从该盘绕的线部分延伸。或者，固定到管状盖构件或其一部分的线的一端的一定长度可以基本沿着管状盖构件或其一部分轴向延伸。从管状盖构件延伸的线可以从该长度的线延伸。The way in which one end of the wire is fixed to the tubular cover portion can cover a certain length of the tubular cover member. For example, a certain length of one end of the wire can be circumferentially wrapped around the tubular cover member or a portion thereof, and the wire of this length also extends along the axial length of the tubular cover member (i.e., in a spiral or coiled manner). The wire extending from the tubular cover member can extend from the coiled wire portion. Alternatively, a certain length of one end of the wire fixed to the tubular cover member or a portion thereof can extend substantially axially along the tubular cover member or a portion thereof. The wire extending from the tubular cover member can extend from the wire of this length.
线的该端可以固定到管状盖构件的中央部分。但是，只要线从管状盖构件的中央部分延伸，线的该端不必局限于固定到管状盖构件的中央部分。因此，换言之，可以认为软组织锚固系统具有固定到管状盖构件的中央部分的线的一端，具体地，线的该端指的是线的最初从管状盖构件延伸的部分(即，是线的确定沿着管状盖构件的、在使用中由线给管状盖构件施加拉力的位置的“端”部)。This end of the wire can be fixed to the central portion of the tubular cover member. However, as long as the wire extends from the central portion of the tubular cover member, this end of the wire does not have to be limited to being fixed to the central portion of the tubular cover member. Therefore, in other words, it can be considered that the soft tissue anchoring system has one end of the wire fixed to the central portion of the tubular cover member, specifically, this end of the wire refers to the portion of the wire that initially extends from the tubular cover member (that is, it is the "end" portion of the wire that determines the position along the tubular cover member where the wire applies tension to the tubular cover member during use).
开口接收的丝线引导构件适合于在植入过程中使管状盖构件穿过身体软组织。换句话说，丝线引导构件适合于在植入过程中通过使管状盖构件穿过身体软组织从而将软组织锚固系统固定在体组织中。管状盖构件穿过身体软组织导致软组织锚固系统植入身体组织中，以固定人造线。The wire guide member received by the opening is suitable for passing the tubular cover member through the body soft tissue during implantation. In other words, the wire guide member is suitable for fixing the soft tissue anchoring system in the body tissue by passing the tubular cover member through the body soft tissue during implantation. Passing the tubular cover member through the body soft tissue causes the soft tissue anchoring system to be implanted in the body tissue to fix the artificial thread.
管状盖构件可以是单个部件(例如，空心管)，其中，线被系绑或以其他方式固定到管状盖构件。管状盖构件可以通过激光切割或加工镍钛诺或不锈钢而形成为单个部件。The tubular cover member can be a single component (eg, a hollow tube) to which the wires are tied or otherwise secured. The tubular cover member can be formed as a single component by laser cutting or machining nitinol or stainless steel.
替代地，管状盖构件可包括外管状构件和内管状构件，其中，外管状构件被配置成接收内管状构件。也就是说，内管状构件可嵌套在外管状构件内和/或与外管状构件同心。内管状构件可限定被配置成接收丝线引导构件的开口。Alternatively, the tubular cover member may include an outer tubular member and an inner tubular member, wherein the outer tubular member is configured to receive the inner tubular member. That is, the inner tubular member may be nested in the outer tubular member and/or concentric with the outer tubular member. The inner tubular member may define an opening configured to receive the wire guide member.
内管状构件可包括喇叭形入口，该喇叭形入口界定被构造用于接收丝线引导构件的开口。喇叭形入口应理解为内管状构件的界定开口的部分，其中，内管状构件的圆周范围相对于内管状构件的其余部分增大。The inner tubular member may comprise a flared inlet defining an opening configured for receiving the wire guiding member.A flared inlet is understood to be a portion of the inner tubular member defining an opening, wherein the circumferential extent of the inner tubular member is increased relative to the remainder of the inner tubular member.
优选地，喇叭形入口包括倾斜面，以便于将丝线引导构件引导到内管状构件中。在丝线引导构件在植入前未被管状盖构件的开口接收的情况下，这种布置可能是优选的。Preferably, the flared inlet comprises an inclined surface to facilitate guiding the wire guiding member into the inner tubular member. This arrangement may be preferred in cases where the wire guiding member is not received by the opening of the tubular cover member prior to implantation.
喇叭形入口可配置为与丝线引导构件的相应部分匹配。也就是说，喇叭形入口可以例如与丝线引导构件的肩部区域或凸起部分的形状互补。喇叭形入口的倾斜面可与丝线引导构件的肩部区域或凸起部分互补。喇叭形入口可在植入织物体期间改善丝线引导构件与管状盖构件之间的接触。The trumpet-shaped inlet can be configured to match the corresponding part of the wire guide member. That is, the trumpet-shaped inlet can be, for example, complementary to the shape of the shoulder area or the raised portion of the wire guide member. The inclined surface of the trumpet-shaped inlet can be complementary to the shoulder area or the raised portion of the wire guide member. The trumpet-shaped inlet can improve the contact between the wire guide member and the tubular cover member during implantation of the fabric body.
内管状构件可通过压配合和/或匹配凹口保持在外管状构件内。内管状盖构件还可或可替代地通过压接操作保持在外管状构件内。The inner tubular member may be retained within the outer tubular member by a press fit and/or matching recesses. The inner tubular cover member may also or alternatively be retained within the outer tubular member by a crimping operation.
喇叭形入口可配置为将内管状构件定位在外管状构件内。内管状构件的靠近开口的一端可通过匹配凹口、压配合和/或压接连接与外管状构件匹配。喇叭形入口可在内管状构件和外管状构件之间提供压配合。内管状构件的远离开口的一端也可经由匹配凹口、压配合和/或压接连接与外管状构件配合。提供至少两个保持区域或点可提高内管状构件在外管状构件内的保持强度。The flared inlet can be configured to position the inner tubular member within the outer tubular member. The end of the inner tubular member near the opening can be matched with the outer tubular member by matching notches, press fits and/or crimp connections. The flared inlet can provide a press fit between the inner tubular member and the outer tubular member. The end of the inner tubular member away from the opening can also be matched with the outer tubular member via matching notches, press fits and/or crimp connections. Providing at least two holding areas or points can increase the retention strength of the inner tubular member within the outer tubular member.
外管状构件可包括肩部区域，该肩部区域构造成与内管状构件配合，远离开口。这可便于将内管状构件定位在外管状构件内，使得由内管状构件限定的开口适当地定位在管状盖构件的端部。The outer tubular member may include a shoulder region configured to cooperate with the inner tubular member, away from the opening. This may facilitate positioning the inner tubular member within the outer tubular member so that the opening defined by the inner tubular member is properly positioned at the end of the tubular cover member.
管状盖构件可构造成接收内管构件和外管构件之间的线。可通过压接、锻造、夹紧、粘合和/或将线夹在内管构件和外管构件之间来将线固定到管状盖构件。还可通过将线缝合或系绑在管状构件上来固定线。The tubular cover member may be configured to receive the wire between the inner and outer tubular members. The wire may be secured to the tubular cover member by crimping, swaging, clamping, bonding, and/or clamping the wire between the inner and outer tubular members. The wire may also be secured by sewing or tying the wire to the tubular member.
外管状构件可包括侧壁和形成在该侧壁中的孔口(即开口)，其中，该孔口接收线。线的端部可在外管状构件和内管状构件之间固定在管状盖构件上。开口可形成在外管状构件的中心区域，从而便于线从管状盖构件的中央部分延伸，并且可选地便于将线的端部固定到管状盖构件的中央部分。The outer tubular member may include a sidewall and an aperture (i.e., an opening) formed in the sidewall, wherein the aperture receives the wire. The end of the wire may be fixed to the tubular cover member between the outer tubular member and the inner tubular member. The opening may be formed in a central region of the outer tubular member to facilitate the wire to extend from the central portion of the tubular cover member, and optionally to facilitate the end of the wire to be fixed to the central portion of the tubular cover member.
外管状构件可包括从孔口向开口延伸的凹槽。凹槽可构造成在植入期间接收线。因此，植入期间线的轮廓可沉入管状盖构件中，从而至少部分地包含在管状盖构件的轮廓内，使得植入部位的尺寸最小化，并且植入期间的创伤可进一步减少。The outer tubular member may include a groove extending from the orifice to the opening. The groove may be configured to receive the wire during implantation. Thus, the contour of the wire may sink into the tubular cover member during implantation, thereby being at least partially contained within the contour of the tubular cover member, minimizing the size of the implantation site and further reducing trauma during implantation.
管状盖构件可包括被构造用于刺穿身体组织的尖头末端，其中，该尖头末端位于管状盖构件的远离被构造成接收丝线引导构件的开口的一端。尖头末端可被构造成当丝线引导构件向管状盖构件施加动力时刺穿身体组织。The tubular cover member may include a pointed tip configured to pierce body tissue, wherein the pointed tip is located at an end of the tubular cover member away from an opening configured to receive the wire guide member. The pointed tip may be configured to pierce body tissue when the wire guide member applies power to the tubular cover member.
尖头末端末端可包括锥形末端，即，具有绕管状盖构件的纵向轴线的旋转对称性的尖头末端。The pointed tip may comprise a tapered tip, ie a pointed tip having rotational symmetry about the longitudinal axis of the tubular cover member.
或者，尖头末端可具有绕管状盖构件的纵向轴线的旋转非对称几何形状。使用用于尖头末端的旋转非对称末端几何形状可有助于尖头末端具有用于其尖头的平面(即，其剪切边缘的平面)的较高的拔模角。使用具有较高拔模角的尖头末端可减小尖头末端刺穿身体软组织所需的力，从而减少植入期间在植入部位处经历的创伤。Alternatively, the pointed tip may have a rotationally asymmetric geometry about the longitudinal axis of the tubular cover member. Using a rotationally asymmetric tip geometry for the pointed tip may help the pointed tip have a higher draft angle for the plane of its tip (i.e., the plane of its shearing edge). Using a pointed tip with a higher draft angle may reduce the force required for the pointed tip to penetrate soft body tissue, thereby reducing the trauma experienced at the implantation site during implantation.
为此，尖头末端可包括斜面。斜面应被理解为定义单个平面，即，在其中斜面的面被磨削(例如，研磨面)或以其他方式形成的平面。To this end, the pointed tip may include a bevel. A bevel is understood to define a single plane, ie a plane in which the face of the bevel is ground (eg, a lapped surface) or otherwise formed.
斜面可限定尖头末端的面。斜面相对于管状盖构件的径向平面的拔模角可大于50°、大于60°、大于70°或大于80°。斜面相对于管状盖构件的纵向轴线的拔模角可小于10°、小于20°、小于30°或小于40°。The bevel may define a face of a pointed tip. The draft angle of the bevel relative to a radial plane of the tubular cover member may be greater than 50°, greater than 60°, greater than 70°, or greater than 80°. The draft angle of the bevel relative to the longitudinal axis of the tubular cover member may be less than 10°, less than 20°, less than 30°, or less than 40°.
尖头末端可包括单个斜面，并可描述为斜面末端或凿子末端(chisel tip)。The pointed tip may include a single bevel and may be described as a bevel tip or a chisel tip.
或者，除了斜面外，尖头末端还可包括两个尖拱平面(lancet plane)。尖拱平面可与该斜面相接，优选是对称地。斜面和每个尖拱平面应被理解为限定各自的平面(例如，研磨平面)。这种末端几何形状可被描述为尖拱状尖头末端。因此，尖头末端可以是尖拱状尖头末端。Alternatively, the pointed end may include two lancet planes in addition to the bevel. The lancet planes may be connected to the bevel, preferably symmetrically. The bevel and each lancet plane should be understood to define a respective plane (e.g., a grinding plane). This end geometry can be described as a lancet-shaped pointed end. Therefore, the pointed end can be a lancet-shaped pointed end.
在被构造为接收丝线引导构件的开口包括盲孔或盲洞的布置中，尖头末端可被视为尖端探针。在被构造为接收丝线引导构件的开口完全延伸穿过管状盖构件的布置中(在这种情况下，这种布置便于制造管状盖构件)，尖头末端可被视为尖端套管。In an arrangement where the opening configured to receive the wire guide member comprises a blind hole or blind aperture, the pointed end may be considered a tip probe. In an arrangement where the opening configured to receive the wire guide member extends completely through the tubular cover member (in this case, such an arrangement facilitates the manufacture of the tubular cover member), the pointed end may be considered a tip cannula.
尖头末端可为可伸缩的尖头末端。管状盖构件的末端：可以具有第一位置，在该第一位置中，末端为尖头末端，即，末端被部署；并且可以具有第二位置，在该位置中，末端为钝化和/或圆形，即末端缩回。第二位置可以是可伸缩的尖头末端的静置位置。可以通过丝线引导构件与管状盖构件的接合将可伸缩的尖头末端从第二位置推至第一位置。The pointed tip may be a retractable pointed tip. The tip of the tubular cover member may have a first position in which the tip is a pointed tip, i.e., the tip is deployed, and may have a second position in which the tip is blunted and/or rounded, i.e., the tip is retracted. The second position may be a resting position of the retractable pointed tip. The retractable pointed tip may be pushed from the second position to the first position by engagement of the wire guide member with the tubular cover member.
外管状构件可限定尖头末端。如果尖头末端永久存在，则内管状构件可包括接收丝线引导构件的盲孔。如果尖头末端是可伸缩的尖头末端，则内管状构件可以是空心的，使得丝线引导构件可致动可伸缩的尖头末端和/或任何合适的部署机构。The outer tubular member may define a pointed end. If the pointed end is permanent, the inner tubular member may include a blind hole to receive the wire guide member. If the pointed end is a retractable pointed end, the inner tubular member may be hollow so that the wire guide member can actuate the retractable pointed end and/or any suitable deployment mechanism.
替代地，管状盖构件可以包括钝的和/或圆形的末端，其中，该钝的和/或圆形的末端位于管状盖构件的远离被构造为接收丝线引导构件的开口的端部处。Alternatively, the tubular cover member may comprise a blunt and/or rounded tip, wherein the blunt and/or rounded tip is located at an end of the tubular cover member distal from the opening configured to receive the wire guiding member.
通过具有钝的和/或圆形的末端，减轻了在植入时或以其它方式由管状盖构件引起的身体组织撕裂和/或进一步创伤的风险。By having a blunt and/or rounded tip, the risk of tearing and/or further trauma to body tissue upon implantation or otherwise caused by the tubular cover member is mitigated.
外管状构件和内管状构件各自限定了沿其整个长度延伸的开口，即，它们沿它们的整个长度是空心的。内管状构件可以被构造为允许丝线引导构件的刺穿部分穿过其中，并且还可以构造为抵接丝线引导构件的肩部或凸起部分。包括刺穿部分的丝线引导构件可以被视为刺穿丝线引导构件，该刺穿部分被构造成在植入锚固系统期间刺穿身体组织。The outer tubular member and the inner tubular member each define an opening extending along their entire length, that is, they are hollow along their entire length. The inner tubular member can be configured to allow the piercing portion of the wire guide member to pass therethrough, and can also be configured to abut against the shoulder or raised portion of the wire guide member. The wire guide member including the piercing portion can be regarded as a piercing wire guide member, which is configured to pierce body tissue during implantation of the anchoring system.
通过使刺穿丝线引导构件能够穿过内管状构件，管状盖构件可包括钝的和/或圆形的末端，同时仍能够在植入锚固系统期间刺穿身体组织。此外，通过提供被构造成抵接丝线引导构件的肩部或凸起部分的内管状构件，可实现通过刺穿丝线引导构件操纵臂部的适当接触。By enabling the piercing wire guide member to pass through the inner tubular member, the tubular cover member can include a blunt and/or rounded end while still being able to pierce body tissue during implantation of the anchoring system. In addition, by providing an inner tubular member configured to abut the shoulder or raised portion of the wire guide member, appropriate contact of the manipulation arm by the piercing wire guide member can be achieved.
此外，使用适合与刺穿丝线引导构件一起使用的管状盖构件可以进一步减少植入部位所经受的创伤，因为丝线引导构件的刺穿部分可以具有例如比产生用于植入的切口的空心针构件的直径小的直径。Furthermore, using a tubular cover member adapted for use with a piercing wire guiding member may further reduce trauma experienced by the implantation site, as the piercing portion of the wire guiding member may have a smaller diameter, for example, than the diameter of the hollow needle member making the incision for implantation.
内管状构件可延伸出外管状构件，并可限定管状盖构件的末端。这种布置导致内管状构件和外管状构件之间位于管状盖构件的末端处的阶梯过渡，这可便于管状盖构件在植入期间更平稳地穿过身体组织。The inner tubular member can extend out of the outer tubular member and can define the end of the tubular cover member. This arrangement results in a stepped transition between the inner tubular member and the outer tubular member at the end of the tubular cover member, which can facilitate smoother passage of the tubular cover member through body tissue during implantation.
或者，外管状构件可包括位于管状盖构件的末端处的锥形部分。也就是说，管状盖构件的末端可由外管状构件限定，而内管状构件的端部可容纳在外管状构件内。这种布置导致管状盖构件的末端与外管状构件之间在管状盖构件的末端处的连续过渡，这可便于管状盖构件在植入期间更平稳地穿过身体组织。Alternatively, the outer tubular member may include a tapered portion at the end of the tubular cover member. That is, the end of the tubular cover member may be defined by the outer tubular member, and the end of the inner tubular member may be contained within the outer tubular member. This arrangement results in a continuous transition between the end of the tubular cover member and the outer tubular member at the end of the tubular cover member, which may facilitate smoother passage of the tubular cover member through body tissue during implantation.
软组织锚固系统可以包括具有基部和从基部延伸的臂部的织物体；其中，臂部构造成朝向基部以折叠的方式塌缩，使得在使用中，身体组织被夹置在基部和臂部之间；其中，管状盖构件固定在臂部的远离基部的端部处。A soft tissue anchoring system may include a fabric body having a base and an arm extending from the base; wherein the arm is configured to collapse toward the base in a folded manner so that, in use, body tissue is clamped between the base and the arm; wherein a tubular cover member is fixed at the end of the arm away from the base.
换句话说，从本发明的另一个方面来看，提供了一种用于植入身体软组织以固定人造线的软组织锚固系统，该锚固系统包括：织物体，包括基部和从基部延伸的臂部；其中，臂部被构造为以折叠的方式朝向基部塌缩，使得在使用中，身体组织被夹在基部和臂部之间；其中，臂部包括管状盖构件，该管状盖构件固定在臂部的远离基部的一端；其中，线的一端固定到管状盖构件并从其中央部分延伸，使得在使用中，该管状盖构件构造成：当被植入身体软组织中并且在线沿远离组织的表面的方向穿过组织时在线的拉力作用下，管状盖构件在平行于身体软组织的表面的平面中延伸；并且其中，管状盖构件构造成接收丝线引导构件，用于在植入期间将锚植入身体组织中并且将臂部拉动通过身体组织。In other words, from another aspect of the present invention, there is provided a soft tissue anchoring system for implanting in body soft tissue to fix an artificial thread, the anchoring system comprising: a fabric body comprising a base and an arm extending from the base; wherein the arm is constructed to collapse toward the base in a folded manner so that, in use, the body tissue is clamped between the base and the arm; wherein the arm comprises a tubular cover member fixed to one end of the arm away from the base; wherein one end of the thread is fixed to the tubular cover member and extends from a central portion thereof, so that, in use, the tubular cover member is constructed such that: when implanted in the body soft tissue and under the action of the tension of the thread as the thread passes through the tissue in a direction away from the surface of the tissue, the tubular cover member extends in a plane parallel to the surface of the body soft tissue; and wherein the tubular cover member is constructed to receive a wire guide member for implanting the anchor into the body tissue and pulling the arm through the body tissue during implantation.
通过提供与管状盖构件相结合的织物体，锚固系统在植入时能够接触更大的身体组织表面积，因此在植入时可以具有更好的稳定性和/或更好的组织内生长。此外，通过提供经由基部附接的可塌缩的臂部，基部本身还可以提供更大的侧表面，以通过该侧表面在植入时连接锚固系统和软身体组织。By providing a fabric body in combination with a tubular cover member, the anchoring system can contact a larger surface area of body tissue when implanted, and thus can have better stability and/or better tissue ingrowth when implanted. In addition, by providing a collapsible arm portion attached via the base, the base itself can also provide a larger side surface through which to connect the anchoring system and soft body tissue when implanted.
此外，与金属体等刚性体相比，使用织物体可减少植入期间和/或植入后锚对身体组织的损伤。织物可以更好地补足其所接触的身体组织得表面，从而将施加在身体组织上的力分散到更大的区域，并减少植入部位处的身体组织所经受的创伤。In addition, the use of a fabric body can reduce damage to body tissue by the anchor during and/or after implantation compared to a rigid body such as a metal body. The fabric can better complement the surface of the body tissue it contacts, thereby distributing the forces applied to the body tissue over a larger area and reducing the trauma experienced by the body tissue at the implantation site.
臂部以折叠的方式向基部塌缩可被视为是手风琴式运动。因此，臂部也可被构造为向基部手风琴式运动，使得在使用中身体组织被夹在基部和臂部之间。The arm portion collapses towards the base portion in a folded manner which can be considered as an accordion-like movement. Therefore, the arm portion can also be configured to accordion-like move towards the base portion so that in use the body tissue is sandwiched between the base portion and the arm portion.
织物体由织物材料制成，由于织物的顺应性，织物体可以自然地设置成折叠和/或像手风琴一样。然而，在一些布置中，臂部可以包括被配置成有助于折叠和/或使得臂部成手风琴状的折叠线、变窄部分和/或弱化部分。The fabric body is made of a fabric material that can naturally be arranged to fold and/or accordion-like due to the conformability of the fabric. However, in some arrangements, the arm portion may include fold lines, narrowed portions, and/or weakened portions configured to facilitate folding and/or accordion-like formation of the arm portion.
应当理解，由于管状盖构件固定在臂部的远离基部的端部，因此在植入期间，当管状盖构件穿过身体软组织时，臂部被布置成被拉过身体软组织。It will be appreciated that, because the tubular cover member is secured to the end of the arm distal to the base, the arm is arranged to be pulled through the soft body tissue as the tubular cover member is passed through the soft body tissue during implantation.
管状盖构件可被视为“端盖”，例如，就管状盖构件如何形成臂部的盖端而言。The tubular cover member may be considered an "end cap", for example, in terms of how the tubular cover member forms the cap end of the arm portion.
臂部可以固定于管状盖构件的开口处和/或朝向管状盖构件的开口而固定，即，固定于管状盖构件的远离管状盖构件的末端(即，管状盖构件的在植入期间在插入方向上的端部)的端部处。The arm portion may be fixed at and/or towards the opening of the tubular cover member, i.e., fixed at the end of the tubular cover member away from the end of the tubular cover member (i.e., the end of the tubular cover member in the insertion direction during implantation).
外管状构件和内管状构件可被构造成将相应臂部的远端部夹置在、压接和/或夹在它们之间，从而将管状盖构件固定到臂部。可另外或替代地使用粘合剂来将管状盖构件固定到臂部。The outer tubular member and the inner tubular member may be configured to sandwich, crimp and/or clamp the distal end of the corresponding arm portion therebetween, thereby securing the tubular cover member to the arm portion. An adhesive may additionally or alternatively be used to secure the tubular cover member to the arm portion.
外管状构件可包括凹槽、通道、孔口或其他合适的特征，用于在外管状构件和内管状构件之间引导臂部。该凹槽、通道、孔口或其他合适的特征可形成为与用于线的孔口周向对齐，并且还可形成在被构造成接收丝线引导构件的开口处或朝向改开口。使线和臂部彼此对齐可提高软组织锚固系统在植入身体软组织中时的稳定性。The outer tubular member may include a groove, channel, orifice or other suitable features for guiding the arm between the outer tubular member and the inner tubular member. The groove, channel, orifice or other suitable features may be formed to circumferentially align with the orifice for the wire, and may also be formed at or toward the opening configured to receive the wire guide member. Aligning the wire and the arm with each other may improve the stability of the soft tissue anchoring system when implanted in the body soft tissue.
将臂部朝向管状盖构件的开口固定并且使线位于管状盖构件的中央部分处可以便于线在受到拉力时对管状盖构件施加扭矩，从而使管状盖构件在植入时平靠着身体软组织。Securing the arms toward the opening of the tubular cover member and locating the wire at the central portion of the tubular cover member may facilitate the wire applying torque to the tubular cover member when under tension, thereby causing the tubular cover member to lie flat against soft body tissue when implanted.
将臂部固定在管状盖构件的开口处和/或朝向管状盖构件的开口而固定也可便于管状盖构件的回收。例如，在回收管状盖构件时，可放松线中的拉力。然后可拉动臂部/织物体以施加拉力。该拉力可导致扭矩被施加到管状盖构件，从而导致管状盖构件旋转，使得其在垂直于身体软组织的表面的平面中延伸(例如，使得其与线共线延伸)。然后可拉动和/或引导管状盖构件穿过身体软组织。因此，这种布置可便于回收管状盖构件，同时还使得最大程度地减小回收过程中身体组织所经受的任何创伤。Fixing the arm at the opening of the tubular cover member and/or towards the opening of the tubular cover member can also facilitate the recovery of the tubular cover member. For example, when the tubular cover member is recovered, the tension in the line can be relaxed. The arm/fabric body can then be pulled to apply the tension. The tension can cause a torque to be applied to the tubular cover member, thereby causing the tubular cover member to rotate so that it extends in a plane perpendicular to the surface of the body soft tissue (for example, so that it extends in line with the line). The tubular cover member can then be pulled and/or guided through the body soft tissue. Therefore, this arrangement can facilitate the recovery of the tubular cover member while also minimizing any trauma to the body tissue during the recovery process.
或者，形成在外管状构件的侧壁中的用于容纳线的孔口也可容纳臂部。因此，臂部和线都可固定到管状盖构件上。Alternatively, the aperture formed in the side wall of the outer tubular member for accommodating the wire may also accommodate the arm. Thus, both the arm and the wire may be fixed to the tubular cover member.
或者，并且如在植入前丝线引导构件由端盖的开口接收的布置中优选的，外管状构件可以不包括用于在外管状构件和内管状构件之间引导臂部的通道和/或限定用于接收丝线引导构件的开口的喇叭形入口。对于不需要在植入期间将丝线引导构件引导到与管状盖构件接合的布置，这可能导致管状盖构件变短和/或更薄(即直径地变窄)，因此更紧凑。Alternatively, and as is preferred in arrangements where the wire guide member is received by an opening in the end cap prior to implantation, the outer tubular member may not include a channel for guiding the arm between the outer tubular member and the inner tubular member and/or a flared inlet defining an opening for receiving the wire guide member. For arrangements where the wire guide member does not need to be guided into engagement with the tubular cover member during implantation, this may result in the tubular cover member being shorter and/or thinner (i.e., diametrically narrower), and therefore more compact.
织物体可以由单层织物或多层织物形成。在这种情况下，织物可以被认为是由细丝或细丝状物形成的编织物。一种可能的材料是聚酯织物，其他材料包括PET、UHMPE、EPTFE、PTFE和类似物。织物体可以由任何合适的柔性、顺应性和生物相容性材料制成。织物体可以通过激光切割现有材料或任何其他合适的制造技术来形成。The fabric body can be formed by a single layer of fabric or a multilayer of fabric. In this case, the fabric can be considered to be a braid formed by filaments or filaments. One possible material is polyester fabric, and other materials include PET, UHMPE, EPTFE, PTFE and the like. The fabric body can be made of any suitable flexible, compliant and biocompatible material. The fabric body can be formed by laser cutting existing materials or any other suitable manufacturing technology.
当线被固定到人造线时，线将在基部后面固定到人造线，即远离管状盖构件而不是在管状盖部分和基部之间。换句话说，线的长度至少可以大于织物体的长度，其第一端连接到管状盖构件，第二端从基部延伸。该第二端位于基部后面，然后可以固定到人造线上。When the cord is secured to the artificial cord, the cord will be secured to the artificial cord behind the base, i.e. away from the tubular cover member and not between the tubular cover portion and the base. In other words, the cord may be at least longer than the length of the fabric body, with a first end connected to the tubular cover member and a second end extending from the base. This second end is located behind the base and may then be secured to the artificial cord.
臂部可被构造为通过穿过臂部和基部的线的作用而朝向基部以折叠的方式塌缩。因此，线可被配置为当拉力施加到线上时，致使臂部朝向基部以折叠的方式塌缩。The arm portion may be configured to collapse in a folded manner toward the base portion by the action of a wire passing through the arm portion and the base portion. Thus, the wire may be configured to cause the arm portion to collapse in a folded manner toward the base portion when tension is applied to the wire.
由于线固定到管状盖构件并且以穿线的方式穿过臂部，因此当对线施加拉力时，在线的拉力下，整个臂部可以朝向基部以折叠方式塌缩。Since the wire is fixed to the tubular cover member and passes through the arm portion in a threaded manner, when tension is applied to the wire, the entire arm portion can collapse toward the base portion in a folded manner under the tension of the wire.
线的穿线定位可便于臂部折叠而塌缩。例如，当拉动线时，线可拖拽臂部中的孔——拉伸线被穿线通过这些孔。因此，臂部可被偏压以相对于拉伸线被穿线通过臂部的每个位置折叠。The threading position of the wire can facilitate the folding and collapse of the arm. For example, when the wire is pulled, the wire can drag on the holes in the arm-the tension wire is threaded through these holes. Therefore, the arm can be biased to fold relative to each position where the tension wire is threaded through the arm.
优选地，锚固系统被配置成使得拉力施加到线的穿过基部的部分。这种布置可便于臂部的整体塌缩。Preferably, the anchoring system is configured so that tension is applied to the portion of the line that passes through the base.Such an arrangement can facilitate the overall collapse of the arm.
线可最多穿过臂部和基部三次或四次。这种布置可便于将织物体中线所穿过的孔进一步分开，和/或使用较短的织物体。相对于锚的尺寸，这些布置中的每一个均可提供织物体的较宽的折叠部分，从而为锚固系统在植入时提供更好的稳定性。使用较短的织物体还可以减小整个软组织锚固系统的尺寸，从而改善其在植入用的递送装置/系统中的封装。The wire can pass through the arm and base up to three or four times. This arrangement can facilitate further separation of the holes through which the wire passes in the fabric body, and/or the use of a shorter fabric body. Each of these arrangements can provide a wider folded portion of the fabric body relative to the size of the anchor, thereby providing better stability for the anchoring system when implanted. Using a shorter fabric body can also reduce the size of the entire soft tissue anchoring system, thereby improving its packaging in the delivery device/system for implantation.
另外，或者作为替代，臂部可以被构造为由于存在由弹性材料形成的支柱而朝向基部折叠地塌缩。弹性材料可以是形状记忆金属，例如镍钛合金。支柱可以至少与每个臂部接触，并且可以进一步与基部接触。支柱可以嵌入或交织在织物体中，和/或可以夹在织物体的各层之间。Additionally, or alternatively, the arms may be configured to collapse foldably toward the base due to the presence of struts formed of an elastic material. The elastic material may be a shape memory metal, such as a nickel titanium alloy. The struts may be in contact with at least each arm, and may further be in contact with the base. The struts may be embedded or interwoven in the fabric body, and/or may be sandwiched between layers of the fabric body.
支柱可包括折叠构型和展开构型。通过施加约束力，支柱可保持在展开构型中。在展开构型中，臂部可延离开基部。在移除约束力后，支柱可返回折叠部分，在该折叠构型中，支柱包括一个或更多个折叠。由于臂部与支柱之间的接触，臂部将具有与支柱相同的形状。因此，支柱可以是被弹性地偏置的支柱，其构造成将折叠中的臂部推向基部。The support column may include a folded configuration and an expanded configuration. By applying a restraining force, the support column may be maintained in the expanded configuration. In the expanded configuration, the arm portion may extend away from the base. After removing the restraining force, the support column may return to a folded portion, in which the support column includes one or more folds. Due to the contact between the arm portion and the support column, the arm portion will have the same shape as the support column. Therefore, the support column can be a resiliently biased support column, which is configured to push the folded arm portion towards the base.
当采用支柱时，线可以仅穿过臂部，或者可以延伸至臂部折叠时形成的褶层附近。When struts are used, the wires may pass only through the arms, or may extend to near the folds formed when the arms are folded.
如上所述的(i)线穿线通过臂部；和(ii)基部和支柱由弹性材料形成中的每一种布置都可以被认为是用于将臂部朝向基部折叠地塌缩的不同的装置。Each of the arrangements described above of (i) threading the wire through the arm; and (ii) forming the base and struts from a resilient material may be considered to be a different means for folding the arm toward the base.
换句话说，从本发明的另一方面来看，提供了一种用于植入身体软组织以固定人造线的软组织锚固系统，该锚固系统包括：织物体，包括基部和从基部延伸的臂部；以及用于使臂部朝向基部以折叠的方式塌缩使得在使用中身体组织被夹在基部和臂部之间的装置；其中，臂部包括管状盖构件，该管状盖构件固定在臂部的远离基部的一端；线的一端固定到管状盖构件并从其中央部分延伸，使得在使用时，管状盖构件被构造成：当被植入身体软组织中、并且当其在远离身体软组织的表面的方向穿行通过组织时在线的拉力作用下，管状盖构件在平行于身体软组织的表面的平面中延伸；并且其中，管状盖构件被构造成接收丝线引导构件，该丝线引导构件用于将锚植入身体组织中，并且在植入期间将臂部拉过身体组织。In other words, from another aspect of the present invention, there is provided a soft tissue anchoring system for implanting into body soft tissue to fix an artificial thread, the anchoring system comprising: a fabric body comprising a base and an arm extending from the base; and a device for causing the arm to collapse toward the base in a folded manner so that the body tissue is clamped between the base and the arm during use; wherein the arm comprises a tubular cover member fixed to one end of the arm away from the base; one end of the thread is fixed to the tubular cover member and extends from a central portion thereof, so that when in use, the tubular cover member is configured such that: when implanted into body soft tissue and when it passes through the tissue in a direction away from the surface of the body soft tissue, under the action of the tension of the thread, the tubular cover member extends in a plane parallel to the surface of the body soft tissue; and wherein the tubular cover member is configured to receive a wire guide member, which is used to implant the anchor into body tissue and to pull the arm through the body tissue during implantation.
换言之，用于使臂部朝向基部以折叠方式塌缩的装置可被等同地认为是用于使臂部朝向基部以折叠方式塌缩的机构和/或被构造为使臂部朝向基部以折叠方式塌缩的塌缩机构，其包括以下布置中的至少一种：(i)线穿过臂部；和(ii)基部和支柱由弹性材料形成；而不脱离上述方面。In other words, the device for causing the arm to collapse in a folding manner toward the base may be equivalently considered as a mechanism for causing the arm to collapse in a folding manner toward the base and/or a collapsing mechanism constructed to cause the arm to collapse in a folding manner toward the base, which includes at least one of the following arrangements: (i) a wire passes through the arm; and (ii) the base and the support are formed of an elastic material; without departing from the above aspects.
管状盖构件可被构造为在植入和/或收回织物体期间与臂部共线地延伸。管状盖构件还可被构造为：在对线施加拉力时平行于臂部的每个褶层的平面延伸。The tubular cover member may be configured to extend in-line with the arm portion during implantation and/or retrieval of the fabric body.The tubular cover member may also be configured to extend parallel to the plane of each fold of the arm portion when tension is applied to the wire.
如上所述，臂部可以固定在管状盖构件的靠近臂部的一端(例如，开口所在的一端)，并且线从管状盖构件的中央区域延伸。因此，在植入期间由于臂部和/或线而施加的拉力可以导致扭矩作用在管状盖构件上，从而促进管状盖构件从其与臂部共线延伸的布置过渡到其在与臂部的每个褶层和/或身体软组织的表面平行的平面中延伸的布置。As described above, the arm portion can be fixed to an end of the tubular cover member near the arm portion (e.g., the end where the opening is located), and the wire extends from the central region of the tubular cover member. Therefore, the tension applied by the arm portion and/or the wire during implantation can cause a torque to act on the tubular cover member, thereby facilitating the transition of the tubular cover member from an arrangement in which it extends in line with the arm portion to an arrangement in which it extends in a plane parallel to the surface of each fold of the arm portion and/or the body soft tissue.
因此，当丝线引导构件与管状盖构件接合时，管状盖构件将伸直并与臂部共线延伸。这可有助于将织物体的臂部植入身体组织中。当线受到拉力并因此使臂部折叠而塌缩时，拉力可使管状盖构件转动以与臂部的褶层平行，并因此与臂部所折叠抵靠的身体组织的表面平行。这可有助于将臂部固定到身体组织，并且还可最小化在植入期间从身体组织突出的管状盖构件的轮廓。例如，管状盖构件可转动而在上述“T”形构型中垂直于拉伸线，使得线垂直于身体组织的表面，并且管状盖构件的长度平行于身体组织的表面，从而防止管状盖构件穿过身体组织而移动。当从身体组织中收回织物体部分时，例如通过从远离管状盖构件的方向拉动，作用于臂部的拉力可使管状盖构件从平行位置自动复位，使得其在收回过程中与臂部共线地延伸。因此，通过将臂部在其一端处联接到管状盖构件，来自臂部的拉力将倾向于拉直管状盖构件(例如从上述的“T”形构型)，使其与臂部对齐，从而与穿过身体组织的孔对齐。这可便于取出并尽量减少取出过程中身体组织所经受的任何创伤。Therefore, when the thread guide member is engaged with the tubular cover member, the tubular cover member will straighten and extend in line with the arm. This can help implant the arm of the fabric body into the body tissue. When the line is subjected to tension and the arm is folded and collapsed, the tension can rotate the tubular cover member to be parallel to the fold of the arm, and therefore parallel to the surface of the body tissue against which the arm is folded. This can help fix the arm to the body tissue, and can also minimize the profile of the tubular cover member protruding from the body tissue during implantation. For example, the tubular cover member can rotate and be perpendicular to the stretch line in the above-mentioned "T" configuration, so that the line is perpendicular to the surface of the body tissue, and the length of the tubular cover member is parallel to the surface of the body tissue, thereby preventing the tubular cover member from moving through the body tissue. When the fabric body part is retracted from the body tissue, for example, by pulling from a direction away from the tubular cover member, the tension acting on the arm can automatically reset the tubular cover member from a parallel position, so that it extends in line with the arm during the retraction process. Thus, by coupling the arm portion at one end thereof to the tubular cover member, the tension from the arm portion will tend to straighten the tubular cover member (e.g., from the "T" configuration described above) so that it is aligned with the arm portion and thus with the hole through the body tissue. This can facilitate removal and minimize any trauma to the body tissue during removal.
织物体可任选地包括加强构件，该加强构件限定多个孔，拉伸线穿线通过这些孔。加强构件例如可被实施为拉伸构件，从而为织物体提供增加的拉伸强度。加强构件可被视为织物体的支柱，并且优选地可包括与织物体互补的形状。除了织物体之外，拉伸线优选地还穿线通过加强构件。加强构件可限定孔，拉伸线穿线通过这些孔。The fabric body may optionally include a reinforcing member defining a plurality of holes through which the tensile wires are threaded. The reinforcing member may, for example, be implemented as a tensile member, thereby providing the fabric body with increased tensile strength. The reinforcing member may be considered as a support for the fabric body, and may preferably include a shape complementary to the fabric body. In addition to the fabric body, the tensile wires are preferably threaded through the reinforcing member. The reinforcing member may define holes through which the tensile wires are threaded.
所述加强构件可以嵌入织物体中。所述加强构件可以与织物体交织在一起。所述加强构件可以夹在织物体的各层之间。The reinforcing member may be embedded in the fabric body. The reinforcing member may be interwoven with the fabric body. The reinforcing member may be sandwiched between layers of the fabric body.
加强构件可以是至少一条交织在织物中的高抗拉强度线，以承受在植入、缩回或在其生命周期内可能施加在织物上的过大的拉伸负载。The reinforcing member may be at least one high tensile strength thread interwoven into the fabric to withstand excessive tensile loads that may be imposed on the fabric during implantation, retraction or during its life cycle.
加强构件可加固织物体，并在拉伸线穿过织物体的点处以及可选地在管状盖构件附接的位置处以及在织物沿其长度变窄的任何点处提供额外的支撑。因此，加强构件可改善织物体的结构完整性。The reinforcing member can reinforce the fabric body and provide additional support at the points where the tensile wire passes through the fabric body and optionally at the location where the tubular cover member is attached and at any point where the fabric narrows along its length. Thus, the reinforcing member can improve the structural integrity of the fabric body.
所述织物体可以为U形织物体，包括基部和从基部延伸的至少两个臂部；其中，每个臂部包括固定在臂部的远离基部的端部处的管状盖构件。The fabric body may be a U-shaped fabric body including a base and at least two arms extending from the base; wherein each arm includes a tubular cover member fixed at an end of the arm away from the base.
换句话说，从另一方面来看，提供了一种用于植入身体软组织中以保持人造线的软组织锚固系统，该锚固系统包括：线；U形织物体，其包括基部和从基部延伸的至少两个臂部；其中，每个臂部构造成朝向基部以折叠的方式塌缩，使得在使用中，身体组织夹在基部和每个臂部之间；以及管状盖构件，固定在每个臂部的远离基部的端部处；其中，线的一端固定到每个管状盖构件并从其中央部分延伸使得在使用中，每个管状盖构件构造成在植入身体软组织中时以及在线沿远离身体软组织的表面的方向穿过组织时在线的拉力作用下，在与身体软组织的表面平行的平面中延伸；并且其中，每个管状盖构件包括开口，该开口被构造成接合丝线引导构件以将U形织物体植入身体组织中。In other words, from another aspect, a soft tissue anchoring system for implanting into body soft tissue to hold an artificial thread is provided, the anchoring system comprising: a thread; a U-shaped fabric body comprising a base and at least two arms extending from the base; wherein each arm is configured to collapse toward the base in a folded manner so that, in use, body tissue is clamped between the base and each arm; and a tubular cover member fixed at the end of each arm away from the base; wherein one end of the thread is fixed to each tubular cover member and extends from a central portion thereof so that, in use, each tubular cover member is configured to extend in a plane parallel to the surface of the body soft tissue under the action of the tension of the thread when implanted into the body soft tissue and when the thread passes through the tissue in a direction away from the surface of the body soft tissue; and wherein each tubular cover member comprises an opening configured to engage a wire guide member to implant the U-shaped fabric body into the body tissue.
通过提供包括从同一基部延伸的至少两个臂部的织物体，锚固系统能够在植入时接触更大的身体组织表面积，因此在植入时可以具有更好的稳定性和/或更好的组织内生长。此外，通过提供经由基部附接的可塌缩的臂部，基部本身还可以提供更大的侧表面，通过该侧表面在植入时连接锚固系统和瓣叶。U形锚固系统(即，具有至少两个臂部的选项)与单个臂部相比可以提供增强的性能。By providing a fabric body comprising at least two arms extending from the same base, the anchoring system is able to contact a larger surface area of body tissue when implanted, and therefore may have better stability and/or better tissue ingrowth when implanted. In addition, by providing a collapsible arm attached via the base, the base itself may also provide a larger lateral surface through which to connect the anchoring system and the leaflet when implanted. A U-shaped anchoring system (i.e., the option of having at least two arms) may provide enhanced performance compared to a single arm.
因此，与包括单个臂部和/或固定构件和/或使用不同设计特征的已知锚固系统相比，上述软组织锚固系统可以具有提高的固定强度。Thus, the soft tissue anchor system described above may have improved fixation strength compared to known anchor systems that include a single arm and/or fixation member and/or utilize different design features.
在本实施例中，使用至少两个臂部，U形体之所以被称为U形体，是因为基部和两个臂部形成了U形。然而，应理解，这仅指具有两个臂部的织物体的单元结构，如果存在更多臂部，形状将有所不同。例如，包括三个臂部的织物体可被视为是W形体，其中,W形体包括两个U形单元。因此，锚固系统可以包括具有多个U形单元的织物体，从而获得适合软组织锚固系统所需用途的尺寸的织物体。In the present embodiment, at least two arms are used, and the U-shaped body is called a U-shaped body because the base and the two arms form a U-shape. However, it should be understood that this only refers to the unit structure of the fabric body with two arms, and if there are more arms, the shape will be different. For example, a fabric body including three arms can be regarded as a W-shaped body, wherein the W-shaped body includes two U-shaped units. Therefore, the anchoring system can include a fabric body with multiple U-shaped units, thereby obtaining a fabric body of a size suitable for the desired use of the soft tissue anchoring system.
基部可限定U形织物体的最大宽度。也就是说，基部可以是织物体的最宽部分。The base may define the maximum width of the U-shaped fabric body. That is, the base may be the widest part of the fabric body.
基部可包括一对翼部。翼部可延伸得比臂部的最外边缘宽。The base may include a pair of wings. The wings may extend wider than the outermost edges of the arms.
通过提供宽度增大的基部，或者至少比臂部宽的基部，基部可被构造为在植入身体组织时为织物体提供更大的侧向支撑。By providing a base portion of increased width, or at least a base portion that is wider than the arm portions, the base portion can be configured to provide greater lateral support to the fabric body when implanted in body tissue.
当使用锚固系统时，基部可以植入瓣叶的心房侧，在心跳期间需要保持该侧。在这种情况下，增加用于心房侧定位的侧向支撑有利于实现瓣叶的宽阔支撑区域。如果基部位于心房侧，则臂部位于心室侧。它们的作用是将锚固系统保持到位并提供一些支撑，而心房侧部分(基部)在心脏收缩(收缩期)期间更积极地承受血流对瓣叶施加的力。When using an anchoring system, the base can be implanted on the atrial side of the leaflet, which side needs to be maintained during the heartbeat. In this case, the addition of lateral support for atrial-side positioning is beneficial to achieve a wide support area for the leaflet. If the base is located on the atrial side, the arms are located on the ventricular side. Their role is to hold the anchoring system in place and provide some support, while the atrial-side part (base) more actively bears the forces exerted by blood flow on the leaflet during heart contraction (systole).
基部可包括形状保持构件。形状保持构件可被构造为增加基部的侧向刚度。形状保持构件可被构造为保持基部的平面范围，或与瓣叶/解剖结构的形状相符的3D形状。The base may include a shape-retaining member. The shape-retaining member may be configured to increase the lateral stiffness of the base. The shape-retaining member may be configured to maintain the planar extent of the base, or a 3D shape that conforms to the shape of the leaflets/anatomy.
通过使用形状保持构件来加固基部，基部可能能够为植入有织物体的身体组织提供更大的侧向支撑。此外，当提供了形状保持构件时，植入过程中织物体在保持人造线时所经受的拉力可以更均匀地分布在基部上。这可以提高植入时织物体的稳定性。By reinforcing the base with a shape-retaining member, the base may be able to provide greater lateral support to the body tissue in which the fabric body is implanted. In addition, when a shape-retaining member is provided, the tension experienced by the fabric body when holding the artificial thread during implantation can be more evenly distributed on the base. This can improve the stability of the fabric body when implanted.
形状保持构件可以由弹性材料形成。基部可以包括折叠构型和展开构型，其中，形状保持构件被构造成在移除约束力时将基部从折叠构型推至展开构型。基部在展开构型中可以是基本平坦的。The shape-retaining member may be formed of an elastic material. The base may include a folded configuration and an expanded configuration, wherein the shape-retaining member is configured to urge the base from the folded configuration to the expanded configuration when the restraining force is removed. The base may be substantially flat in the expanded configuration.
形状保持构件可以嵌入、与基部的各层交织和/或夹在基部的各层之间。The shape-retaining member may be embedded in, interwoven with, and/or sandwiched between the layers of the base.
基部可以通过将织物体的一部分向后折叠于其自身之上并将形状保持构件夹在其中来形成。形状保持构件和/或织物体的折叠部分可通过粘合剂、超声波焊接、缝合或其他合适的固定方式固定到位。The base can be formed by folding a portion of the fabric body back on itself and sandwiching the shape-retaining member therebetween. The shape-retaining member and/or the folded portion of the fabric body can be fixed in place by adhesive, ultrasonic welding, sewing or other suitable fixing means.
形状保持构件可包括荧光标记。荧光标记可在植入和/或收回期间通过成像帮助定位织物体。The shape-retaining member may include a fluorescent marker. The fluorescent marker may aid in locating the fabric body by imaging during implantation and/or retrieval.
形状保持构件可以由诸如不锈钢、钛或镍钛合金之类的形状保持金属形成。形状保持构件可以通过激光切割形成，或者通过对由类似材料制成的线材进行整形而形成。The shape-retaining member may be formed of a shape-retaining metal such as stainless steel, titanium, or nickel-titanium alloy. The shape-retaining member may be formed by laser cutting, or by shaping a wire made of a similar material.
基部可以提供用于在植入后收回织物体的表面。可以通过抓握住基部来将臂部从身体组织中拉出并将基部拉离身体组织而收回织物体。形状保持构件可提高收回的容易度，因为形状保持构件可帮助分散收回期间基部所经受的拉力。The base can provide a surface for retracting the fabric body after implantation. The fabric body can be retracted by grasping the base to pull the arms out of the body tissue and pull the base away from the body tissue. The shape-retaining member can increase the ease of retraction because the shape-retaining member can help distribute the tension experienced by the base during retraction.
基部中的形状保持构件还可以防止臂部在被部署时过度延伸穿过瓣叶，因为它可以在臂被导丝拉过组织时充当止动件，这样，基部与形状保持构件相结合可以限制部署丝线在部署过程中可以延伸的距离。The shape-retaining member in the base can also prevent the arms from overextending through the leaflets when deployed because it can act as a stop as the arms are pulled through tissue by the guidewire, thus, the base in combination with the shape-retaining member can limit the distance the deployment wire can extend during deployment.
基部可被构造为由圈套抓握，并且可选地可使用荧光标记来定位基部。例如，圈套可在臂部最初从基部延伸的位置处环绕臂部，在植入时与基部位于身体组织的同一侧。然后，可收紧圈套，使得在收回时，圈套抓握住基部。一对翼部可提供基部的加宽表面，通过该加宽表面，基部可被圈套抓握。The base can be configured to be grasped by a snare, and fluorescent markings can optionally be used to locate the base. For example, the snare can be wrapped around the arm at the location where the arm initially extends from the base, on the same side of the body tissue as the base when implanted. The snare can then be tightened so that when retracted, the snare grasps the base. A pair of wings can provide a widened surface of the base by which the base can be grasped by the snare.
与形状保持构件组合的基部可帮助将软组织锚固系统放置在瓣叶的更宽区域(窄而深)的位置，同时仍实现瓣叶支撑。The base in combination with the shape retaining member can help position the soft tissue anchoring system in a wider area of the leaflets (narrow and deep) while still achieving leaflet support.
织物体可包括在基部和(每个)臂部之间延伸的窄腰部。在植入后，窄腰部可与身体软组织对齐，使得窄腰部在植入部位处被身体软组织包围。窄腰部可被配置为比软组织锚固系统将植入的身体软组织的厚度更长。例如，窄腰部的长度可以是：大于至少1毫米；大于至少2毫米；或大于至少3毫米。窄腰部的长度可在1毫米至3毫米之间。窄腰部可同样被视为臂部的一部分，使得臂部包括在臂部的靠近基部的端部处的窄腰部，或者可替代地被视为如上所述的其相应的部分。窄腰部可稳定基部在身体组织附近的植入。此特征还可有助于在拉紧线之前将臂部保持到位。The fabric body may include a narrow waist extending between the base and (each) arm. After implantation, the narrow waist may be aligned with body soft tissue so that the narrow waist is surrounded by body soft tissue at the implantation site. The narrow waist may be configured to be longer than the thickness of the body soft tissue into which the soft tissue anchoring system is to be implanted. For example, the length of the narrow waist may be: greater than at least 1 mm; greater than at least 2 mm; or greater than at least 3 mm. The length of the narrow waist may be between 1 mm and 3 mm. The narrow waist may also be considered as part of the arm, such that the arm includes the narrow waist at the end of the arm near the base, or may alternatively be considered as its corresponding part as described above. The narrow waist may stabilize the implantation of the base near body tissue. This feature may also help to keep the arm in place before tightening the wire.
每个臂部可设有各自的线。每条线可以是人造线，即充当可植入索的线。该线可如上所述固定到每个管状盖构件的中央区域。Each arm may be provided with a respective line. Each line may be an artificial line, ie a line acting as an implantable cable. The line may be fixed to the central region of each tubular cover member as described above.
例如，在软组织锚包括至少两个臂部的一些布置中，人造线可以是用于其中一个臂部的线，并且对于其余的臂部，可以采用附加的线，每个附加的线都固定到人造线(滑动接合或稳固接合)。另外，或者替代地，两个臂部可以包括共同的线，该线连接到邻近基部的另一臂部的线/人造线。线的第一端可以连接到第一臂部的管状盖构件，并且线的第二端可以连接到第二臂部的管状盖构件。然后，线的中央部分可以固定到人造线/任何其他线上。For example, in some arrangements where the soft tissue anchor includes at least two arms, the artificial wire can be the wire for one of the arms, and for the remaining arms, additional wires can be employed, each of which is secured to the artificial wire (either sliding engagement or secure engagement). Additionally, or alternatively, the two arms can include a common wire that is connected to the wire/artificial wire of the other arm adjacent to the base. The first end of the wire can be connected to the tubular cover member of the first arm, and the second end of the wire can be connected to the tubular cover member of the second arm. The central portion of the wire can then be secured to the artificial wire/any other wire.
在线穿线经过臂部的情况下，对于每个臂部，可以提供：基部中的孔；窄腰部中的孔；以及臂部中的至少一个孔。窄腰部中的孔可以定位的更靠近基部而不是臂部(即，该孔可以被定位在基部附近)。这种布置可以改善织物体在身体软组织周围的压缩，因为在靠近基部的窄腰部中布置孔促使了基部朝向身体软组织/朝向塌缩的臂部塌缩。因此，可以改善植入后锚固系统的稳定性。In the case where the thread is threaded through the arm, for each arm, there may be provided: a hole in the base; a hole in the narrow waist; and at least one hole in the arm. The hole in the narrow waist may be positioned closer to the base than the arm (i.e., the hole may be positioned near the base). This arrangement may improve the compression of the fabric body around the body soft tissue, because the arrangement of the hole in the narrow waist near the base causes the base to collapse towards the body soft tissue/towards the collapsed arm. Thus, the stability of the anchoring system after implantation may be improved.
当不设置窄腰部时，针对每个臂部，可以提供：基部中的孔；以及臂部中的至少两个孔。When no narrow waist is provided, for each arm portion there may be provided: a hole in the base portion; and at least two holes in the arm portion.
应当理解，臂部和基部的上述特征可适用于包括一个臂部的软组织锚固系统以及包括至少两个臂部的软组织锚固系统。It should be understood that the above-described features of the arm and base are applicable to soft tissue anchor systems including one arm as well as soft tissue anchor systems including at least two arms.
如上所述，人造线可以连接到线的远离固定到中央部分的端部的部分。在一些布置中，人造线可以可滑动地连接到线的穿线通过基部的部分。人造线可被布置成将拉力施加到线上。As described above, the artificial line may be connected to a portion of the line away from the end fixed to the central portion. In some arrangements, the artificial line may be slidably connected to a portion of the line threaded through the base. The artificial line may be arranged to apply tension to the line.
人造线可通过任何合适的结(例如,系绳结)可滑动地连接到线上。或者，人造线可通过中间构件(例如,连接到人造线的孔眼，拉伸线穿过该孔眼)可滑动地连接到线上。The artificial line can be slidably connected to the line by any suitable knot (e.g., a tether knot). Alternatively, the artificial line can be slidably connected to the line by an intermediate member (e.g., an eyelet connected to the artificial line, through which the tensile line passes).
通过使人造线能够相对于拉伸线滑动，拉力被施加到拉伸线上的点可以随着拉力的施加而自然地调节。这可以帮助将拉力分布在每个臂部上，使得每个臂部被适当地收回。此外，这种布置可以便于将织物体相对于人造线成角度地植入身体组织中。By enabling the artificial wire to slide relative to the stretch wire, the point at which the tension is applied to the stretch wire can naturally adjust as the tension is applied. This can help distribute the tension on each arm so that each arm is properly retracted. In addition, this arrangement can facilitate implanting the fabric body into body tissue at an angle relative to the artificial wire.
或者，人造线可以固定地连接至线，使得线和人造线的相对位置不会改变。Alternatively, the artificial line may be fixedly connected to the wire so that the relative positions of the wire and artificial line do not change.
替代于包括U形织物体，软组织锚固系统可以包括多个如上所述的“T形杆”锚。例如，软组织锚固系统可以包括至少两个T形杆锚，每个都配置为接收丝线引导构件。T形杆锚以连接到共同的线，从而将它们连接起来。Instead of including a U-shaped fabric body, the soft tissue anchoring system may include a plurality of "T-bar" anchors as described above. For example, the soft tissue anchoring system may include at least two T-bar anchors, each configured to receive a wire guide member. The T-bar anchors are connected to a common wire, thereby connecting them.
换句话说，从本发明的另一方面来看，提供了一种用于植入身体软组织中以固定人造线的软组织锚固系统，该锚固系统包括：线；和多个管状盖构件；其中，线的一端固定到每个管状盖构件并从其中央部分延伸，使得在使用中，每个管状盖构件被配置成在植入身体软组织中时并且在线沿远离身体软组织的表面的方向穿过组织时在线的拉力作用下，在与身体软组织的表面平行的平面中延伸；并且其中，每个管状盖构件包括开口，该开口被配置成接收丝线引导构件，以在植入期间使管状盖构件穿过身体软组织。In other words, from another aspect of the present invention, a soft tissue anchoring system for implanting in body soft tissue to fix an artificial wire is provided, the anchoring system comprising: a wire; and a plurality of tubular cover members; wherein one end of the wire is fixed to each tubular cover member and extends from a central portion thereof, so that in use, each tubular cover member is configured to extend in a plane parallel to the surface of the body soft tissue under the action of the tension of the wire when implanted in the body soft tissue and when the wire passes through the tissue in a direction away from the surface of the body soft tissue; and wherein each tubular cover member comprises an opening configured to receive a wire guide member to enable the tubular cover member to pass through the body soft tissue during implantation.
在使用中，每个开口可被构造为接收相应的丝线引导构件，使得每个管状盖构件被同时植入身体组织中。或者，在使用中，每个开口可被构造为依次接收共同的丝线引导构件，使得每个管状盖构件依次植入身体组织中。In use, each opening can be configured to receive a corresponding wire guide member so that each tubular cover member is implanted in body tissue at the same time. Alternatively, in use, each opening can be configured to receive a common wire guide member in sequence so that each tubular cover member is implanted in body tissue in sequence.
每个T形杆锚可配备有自己的线。每条线可以是人造线，即充当可植入索的线。或者，线可以固定到每个管状盖构件/T形杆锚上。Each T-bar anchor may be provided with its own line. Each line may be a synthetic line, i.e. a line that acts as an implantable cable. Alternatively, a line may be fixed to each tubular cover member/T-bar anchor.
例如，在软组织锚至少包括T形杆锚的某些布置中，人造线可以是用于T形杆锚之一的线，而对于其余的T形杆锚，可以采用附加的线，每条附加的线都固定到人造线上(滑动接合或稳固接合)。此外，或者作为替代，两个T形杆锚可以包括共同的线，该线连接到人造线/另一T形杆锚的线。该共同的线的第一端可以连接到第一个T形杆锚的管状盖构件，并且共同的线的第二端可以连接到第二个T形杆锚的管状盖构件。然后，可以将线的中央部分固定到人造线/任何其他线上。该共同的线也可以被视为也连接到管状盖构件的任何线之间的固定件。For example, in certain arrangements where the soft tissue anchor includes at least a T-bar anchor, the artificial line can be the line for one of the T-bar anchors, while for the remaining T-bar anchors, additional lines can be employed, each of which is secured to the artificial line (either in a sliding engagement or a secure engagement). In addition, or as an alternative, two T-bar anchors can include a common line that is connected to the artificial line/line of the other T-bar anchor. The first end of the common line can be connected to the tubular cover member of the first T-bar anchor, and the second end of the common line can be connected to the tubular cover member of the second T-bar anchor. The central portion of the line can then be secured to the artificial line/any other line. The common line can also be considered a fixture between any lines that are also connected to the tubular cover member.
拉伸线可包括多条系绳线，每条系绳线与相应的管状盖构件相关联(即，每条系绳线的端部固定至相应的管状盖构件)。The tension line may include a plurality of tether lines, each tether line being associated with a respective tubular cover member (ie, an end of each tether line being secured to a respective tubular cover member).
每条系绳线优选连接到公共的系绳点，其中，系绳点被配置成当软组织锚固系统植入身体软组织中并且系绳点本身处于拉力下时使每条系绳线处于拉力下。也就是说，系绳点被配置成当每条系绳线在远离身体软组织的表面的方向穿过组织并且系绳点本身处于拉力下时使每条系绳线处于拉力下。Each tether line is preferably connected to a common tether point, wherein the tether point is configured to place each tether line under tension when the soft tissue anchor system is implanted in the body soft tissue and the tether point itself is under tension. That is, the tether point is configured to place each tether line under tension when each tether line passes through the tissue in a direction away from the surface of the body soft tissue and the tether point itself is under tension.
通过提供包括多条系绳线的布置，每条系绳线由于共同的系绳点而处于拉力之下，软组织锚的管状盖构件可以各自受到拉力，从而将它们拉向与系绳点相交的平面或轴线，并沿着施加到系绳点的拉力的方向。这可以导致每个管状盖构件被朝向彼此推动，并且进而在植入时捕获、聚集和/或夹紧位于管状盖构件之间的任何多余身体组织。因此，这种布置可以恢复身体软组织的形状和/或为身体组织提供额外的结构支撑。By providing an arrangement including a plurality of tether lines, each tether line being under tension due to a common tether point, the tubular cover members of the soft tissue anchor can each be subjected to tension, thereby pulling them toward a plane or axis intersecting the tether point and in the direction of the tension applied to the tether point. This can result in each tubular cover member being urged toward each other and thereby capturing, gathering and/or clamping any excess body tissue located between the tubular cover members when implanted. Thus, this arrangement can restore the shape of soft body tissue and/or provide additional structural support to the body tissue.
当身体软组织是心脏瓣膜瓣叶时，包括多条分别连接到公共系绳点的系绳线的布置可能特别有利。如上所述，通过捕获多余的瓣叶组织而导致的瓣叶组织的重塑形已被发现提供了与瓣叶切除相似的结果。切除是现有心脏瓣膜修复方法中的常见手术步骤，其中，外科医生切除心脏瓣膜的受损部分并将剩余组织的边缘缝合在一起。切除通常在存在过多瓣叶组织的情况下进行。然而，通过提供包括系绳点和多条系绳线的线布置，可以避免切除步骤的需要。这可以简化整个手术过程。When the soft body tissue is a heart valve leaflet, an arrangement comprising multiple tether lines each connected to a common tether point may be particularly advantageous. As described above, reshaping of the leaflet tissue by capturing excess leaflet tissue has been found to provide similar results to leaflet resection. Resection is a common surgical step in existing heart valve repair methods, in which the surgeon resects the damaged portion of the heart valve and sutures the edges of the remaining tissue together. Resection is typically performed in the presence of excess leaflet tissue. However, by providing a line arrangement comprising a tether point and multiple tether lines, the need for a resection step can be avoided. This can simplify the entire surgical procedure.
在所述实施例中，所述线可被认为是一种系绳装置，其中，该系绳装置包括多条系绳线。每条系绳线的一端(即第一端)将固定到相应的管状盖构件并从其中央部分延伸，使得在使用中，每个管状盖构件被配置成在植入身体软组织中时并且在系绳线沿远离组织的表面的方向穿过组织时在系绳线的拉力作用下，在与身体软组织的表面平行的平面中延伸。每条系绳线将在第二端处进一步固定到系绳点，或者固定到另一管状盖构件，其中系绳线的中央部分连接到公共系绳点。In the described embodiments, the line can be considered as a tether device, wherein the tether device includes a plurality of tether lines. One end (i.e., the first end) of each tether line will be fixed to the corresponding tubular cover member and extend from its central portion, so that in use, each tubular cover member is configured to extend in a plane parallel to the surface of the body soft tissue when implanted in the body soft tissue and under the tension of the tether line when the tether line passes through the tissue in a direction away from the surface of the tissue. Each tether line will be further fixed to a tether point at the second end, or fixed to another tubular cover member, wherein the central portion of the tether line is connected to the common tether point.
系绳点可以是固定的系绳点，使得系绳线在连接处不能相对于系绳点移动。系绳点可以是固定的结、眼板或其他合适的紧固件。The tether point may be a fixed tether point such that the tether line cannot move relative to the tether point at the point of connection. The tether point may be a fixed knot, eye plate or other suitable fastener.
或者，系绳点可以是可滑动的系绳点，使得系绳线可以相对于连接处的系绳点移动。系绳线可以以上述方式自行调节。系绳点可以是系绳结，并通过一条共同的线提供多条系绳线。Alternatively, the tether point may be a slidable tether point so that the tether line can move relative to the tether point at the connection. The tether line may be self-adjusting in the manner described above. The tether point may be a tether knot and provide multiple tether lines through a common line.
人造线可以连接到系绳点，并且可以配置为对系绳点施加拉力，即，使系绳点处于拉力作用下。The artificial line may be connected to the tether point and may be configured to apply tension to the tether point, ie, to place the tether point under tension.
人造线可以构成其中一条系绳线。其余系绳线可以在沿着人造线定位的系绳点处与人造线连接。The artificial line may constitute one of the tether lines. The remaining tether lines may be connected to the artificial line at tether points located along the artificial line.
优选地，所述系绳点被布置成在系绳点的第一侧上提供多个系绳线中的每一条，其中单个拉力和/或人造线位于系绳点的与第一侧相对的第二侧上。这样的配置可以提供从系绳点到每条系绳线的更稳定的拉力分布。Preferably, the tether point is arranged to provide each of the plurality of tether lines on a first side of the tether point, wherein a single tension and/or artificial line is located on a second side of the tether point opposite the first side. Such a configuration may provide a more stable tension distribution from the tether point to each tether line.
所述多条系绳线可以由两条系绳线组成，在这种情况下，系绳装置可以包括Y形配置。所述多条系绳线可以由三条系绳线组成，在这种情况下，系绳装置可以包括三叉形配置。The plurality of tether lines may consist of two tether lines, in which case the tether arrangement may comprise a Y-shaped configuration. The plurality of tether lines may consist of three tether lines, in which case the tether arrangement may comprise a trident-shaped configuration.
从本发明的第二方面来看，提供了一种软组织锚固系统，用于植入身体软组织中以固定人造线。锚固系统包括：U形织物体，包括基部和从基部延伸的至少两个臂部；其中，每个臂部被配置成朝向基部以折叠方式塌缩，使得在使用时，身体组织被夹在基部和每个臂部之间。From a second aspect of the present invention, a soft tissue anchoring system is provided for implantation in body soft tissue to fix an artificial thread. The anchoring system comprises: a U-shaped fabric body, comprising a base and at least two arms extending from the base; wherein each arm is configured to collapse toward the base in a folded manner, so that in use, body tissue is sandwiched between the base and each arm.
通过提供包括两个或更多个从同一基部延伸的臂部的织物体，锚固系统在植入时能够接触更大的身体组织表面积，因此在植入时可以具有更好的稳定性和/或更好的组织内生长。此外，通过提供通过基部连接的可塌缩的臂部，基部本身还可以提供更大的侧表面，通过该更大的侧表面在植入时连接锚固系统和瓣叶。U形锚固系统(即具有至少两个臂部)与单个臂部相比可以提供增强的性能。By providing a fabric body comprising two or more arms extending from the same base, the anchoring system can contact a larger surface area of body tissue when implanted, and thus can have better stability and/or better tissue ingrowth when implanted. In addition, by providing collapsible arms connected by the base, the base itself can also provide a larger side surface through which to connect the anchoring system and the leaflet when implanted. A U-shaped anchoring system (i.e., having at least two arms) can provide enhanced performance compared to a single arm.
因此，与包括单个臂部和/或固定构件和/或使用不同设计特征的已知锚固系统相比，上述软组织锚固系统可以具有提高的固定强度。Thus, the soft tissue anchor system described above may have improved fixation strength compared to known anchor systems that include a single arm and/or fixation member and/or utilize different design features.
此外，与金属体等刚性体相比，使用织物体可减少植入期间和/或植入后锚对身体组织的损伤。织物可更好地与其接触的身体组织表面互补，从而将施加在身体组织上的力分散到更大的区域，并减少植入部位处的身体组织所经受的创伤。In addition, the use of a fabric body can reduce damage to body tissue by the anchor during and/or after implantation compared to a rigid body such as a metal body. The fabric can better complement the surface of the body tissue it contacts, thereby distributing the forces applied to the body tissue over a larger area and reducing the trauma experienced by the body tissue at the implantation site.
臂部向基部以折叠方式的塌缩可视为手风琴式运动。因此，臂部也可被配置为朝向基部手风琴式运动，使得在使用中身体组织被夹在基部和臂部之间。The collapse of the arm portion toward the base portion in a folded manner can be regarded as an accordion-like movement. Therefore, the arm portion can also be configured to accordion-like move toward the base portion so that in use, body tissue is clamped between the base portion and the arm portion.
织物体由织物材料制成，由于织物的顺应性，织物体可以自然地设置成折叠和/或成手风琴状。然而，在一些布置中，臂部可以包括折叠线、变窄部分和/或弱化部分，这些部分被配置成有助于折叠臂部和/或使臂部成手风琴状。The fabric body is made of a fabric material that can naturally be arranged to fold and/or accordion-like due to the conformability of the fabric. However, in some arrangements, the arm portion may include a fold line, a narrowed portion, and/or a weakened portion that is configured to facilitate folding and/or accordion-like the arm portion.
在一种布置中，每个臂部可以配置为通过穿过臂部和基部的拉伸线的作用而朝向基部以折叠方式塌缩。当使用两个臂部时，每个臂部可以具有自己的拉伸线。因此，当拉力施加到拉伸线上时，拉伸线可以有利地配置为将臂部朝向基部以折叠方式塌缩。可以理解的是，每个拉伸线都可以充当可植入的腱索(即，拉伸线可以是人造线)。In one arrangement, each arm may be configured to collapse in a folding manner toward the base by the action of a stretch wire passing through the arm and the base. When two arms are used, each arm may have its own stretch wire. Thus, when tension is applied to the stretch wire, the stretch wire may advantageously be configured to collapse the arm in a folding manner toward the base. It will be appreciated that each stretch wire may act as an implantable chordae tendineae (i.e., the stretch wire may be an artificial wire).
优选地，拉伸线在臂部的远离基部的一端固定到臂部。因此，当拉力施加到拉伸线上时，整个臂部可以被配置为朝向基部以折叠方式塌缩。Preferably, the stretch wire is fixed to the arm at one end of the arm away from the base. Therefore, when a tensile force is applied to the stretch wire, the entire arm can be configured to collapse in a folding manner toward the base.
拉伸线的穿线定位可便于臂部以折叠方式塌缩。例如，当拉动拉伸线时，拉伸线可以拉拽臂部中的孔——拉伸线被穿线通过这些孔。因此，臂部可相对于拉伸线被穿线通过臂部的每个位置被偏压而折叠。The threading position of the tension wire can facilitate the arm to collapse in a folded manner. For example, when the tension wire is pulled, the tension wire can pull on the holes in the arm through which the tension wire is threaded. Therefore, the arm can be biased to fold relative to each position where the tension wire is threaded through the arm.
优选地，锚固系统被配置成使得拉力施加到拉伸线的穿线通过基部的一部分。这种布置可便于臂部的整体塌缩。Preferably, the anchoring system is configured so that tension is applied to a portion of the base through which the tension line is threaded. This arrangement can facilitate the overall collapse of the arm.
线可以被穿线通过臂部和基部最多三次或四次。这种布置可便于将线所穿线通过的织物体中的孔进一步分开，和/或使用较短的织物体。相对于锚的尺寸，这些布置中的每一个均可提供较宽的织物体折叠部分，从而为锚系统在植入时提供更好的稳定性。使用较短的织物体还可以减小整个软组织锚固系统的尺寸，从而改善其在用于植入的递送装置/系统中的包装。The wire can be threaded through the arm and base up to three or four times. This arrangement can facilitate further separation of the holes in the fabric body through which the wire is threaded, and/or the use of a shorter fabric body. Each of these arrangements can provide a wider fabric body fold relative to the size of the anchor, thereby providing better stability for the anchor system when implanted. Using a shorter fabric body can also reduce the size of the entire soft tissue anchoring system, thereby improving its packaging in a delivery device/system for implantation.
软组织锚固系统可包括人造线，即，织物体可与人造线结合。The soft tissue anchoring system may comprise an artificial thread, ie the fabric body may be combined with the artificial thread.
人造线可以固定地连接到线上，使得线和人造线的相对位置不会改变。The artificial line may be fixedly connected to the wire so that the relative position of the wire and the artificial line does not change.
人造线可以可滑动地连接到拉伸线的穿线通过基部的部分。人造线可布置成将拉力施加到拉伸线上。The synthetic wire may be slidably connected to the portion of the tensile wire threaded through the base. The synthetic wire may be arranged to apply tension to the tensile wire.
或者，人造线可以通过任何合适的结(例如系绳结)可滑动地连接到拉伸线上。或者，人造线可以通过中间构件(例如，连接到人造线的孔眼，拉伸线穿过该孔眼)可滑动地连接到拉伸线上。Alternatively, the artificial line may be slidably connected to the tensile line by any suitable knot (e.g., a tether knot). Alternatively, the artificial line may be slidably connected to the tensile line by an intermediate member (e.g., an eyelet connected to the artificial line through which the tensile line passes).
通过使人造线能够相对于拉伸线滑动，施加拉力到拉伸线上的点可以随着施加的拉力而自然地调节。这可以帮助将拉力分布在每个臂部上，使得每个臂部被适当地收回。此外，这种布置可以便于将织物体相对于人造线成角度地植入身体组织中。By enabling the artificial wire to slide relative to the stretch wire, the point at which the tension is applied to the stretch wire can naturally adjust with the tension applied. This can help distribute the tension on each arm so that each arm is properly retracted. In addition, this arrangement can facilitate implanting the fabric body into body tissue at an angle relative to the artificial wire.
可选地，织物体可包括加强构件，该加强构件限定多个孔，拉伸线穿过这些孔。加强构件例如可实现为拉伸构件，从而为织物体提供增加的拉伸强度。加强构件可被视为织物体的支柱，并且优选地可包括与织物体互补的形状。除了织物体之外，拉伸线优选地还穿线通过加强构件。加强构件可限定孔，拉伸线穿过这些孔。Alternatively, the fabric body may include a reinforcing member defining a plurality of holes through which the tensile wires pass. The reinforcing member may be implemented, for example, as a tensile member, thereby providing the fabric body with increased tensile strength. The reinforcing member may be considered as a support for the fabric body and may preferably include a shape complementary to the fabric body. In addition to the fabric body, the tensile wires are preferably threaded through the reinforcing member. The reinforcing member may define holes through which the tensile wires pass.
所述加强构件可以嵌入织物体中。所述加强构件可以与织物体交织在一起。所述加强构件可以夹在织物体的各层之间。The reinforcing member may be embedded in the fabric body. The reinforcing member may be interwoven with the fabric body. The reinforcing member may be sandwiched between layers of the fabric body.
加强构件可以是至少一条高抗拉强度线，交织在织物中，以承受在植入、收回或在其生命周期内可能施加在织物上的过大的拉伸负载。The reinforcing member may be at least one high tensile strength thread interwoven into the fabric to withstand excessive tensile loads that may be imposed on the fabric during implantation, retrieval or during its life cycle.
加强构件可加固织物体，并在拉伸线穿线通过织物体的点处以及可选地在端盖附接处和织物沿其长度变窄的任何点处提供额外支撑。因此，加强构件可改善织物体的结构完整性。The reinforcing members may reinforce the fabric body and provide additional support at the points where the tensile wires are threaded through the fabric body and optionally at the end cap attachments and at any points where the fabric narrows along its length. Thus, the reinforcing members may improve the structural integrity of the fabric body.
另外或替代地，由于存在由弹性材料形成的支柱，臂部可以配置为朝向基部以折叠方式塌缩。弹性材料可以是形状记忆金属，例如镍钛合金。支柱可以与至少每个臂部接触，并且可以进一步与基部接触。支柱可以嵌入或交织在织物体中，和/或可以夹在织物体的各层之间。Additionally or alternatively, the arm portion may be configured to collapse in a folded manner toward the base portion due to the presence of a strut formed of an elastic material. The elastic material may be a shape memory metal, such as a nickel titanium alloy. The strut may be in contact with at least each arm portion, and may further be in contact with the base portion. The strut may be embedded or interwoven in the fabric body, and/or may be sandwiched between layers of the fabric body.
支柱可包括折叠构型和展开构型。通过施加约束力，支柱可保持在展开构型中。在展开构型中，臂部可从基部延伸开来。在移除约束力后，支柱可返回折叠构型，其中，支柱包括一个或多个褶层。由于臂部与支柱之间的接触，臂部将具有与支柱相同的形状。因此，支柱可以是弹性偏置支柱，其构造成将臂部以折叠方式推向基部。The strut may comprise a folded configuration and an expanded configuration. The strut may be maintained in the expanded configuration by applying a restraining force. In the expanded configuration, the arm may extend away from the base. Upon removal of the restraining force, the strut may return to a folded configuration, wherein the strut comprises one or more folds. Due to contact between the arm and the strut, the arm will have the same shape as the strut. Thus, the strut may be a resiliently biased strut configured to urge the arm towards the base in a folded manner.
当使用支柱时，线可以穿线通过臂部。When a brace is used, the wire may be threaded through the arm.
如上所述的(i)线穿线通过臂部；和(ii)基部和支柱由弹性材料形成中的每一种布置都可以被认为是用于使臂部朝向基部以折叠方式塌缩的不同的装置。Each of the arrangements described above of (i) threading the wire through the arm; and (ii) forming the base and struts from a resilient material may be considered to be a different means for causing the arm to collapse in an accordion fashion towards the base.
换句话说，从本发明的另一方面来看，提供了一种软组织锚固系统，用于植入身体软组织中以保持线。锚固系统包括：U形织物体，其包括基部和从基部延伸的至少两个臂部；以及用于使每个臂部朝向基部以折叠方式塌缩，从而使得在使用中，身体组织被夹在基部和每个臂部之间的装置。In other words, from another aspect of the invention, there is provided a soft tissue anchoring system for implantation in body soft tissue to hold a line. The anchoring system comprises: a U-shaped fabric body comprising a base and at least two arms extending from the base; and means for causing each arm to collapse in a folded manner towards the base so that, in use, body tissue is sandwiched between the base and each arm.
换言之，用于使臂部朝向基部以折叠方式塌缩的装置可同样被认为是用于使臂部朝向基部以折叠方式塌缩的机构和/或配置为将臂部朝向基部以折叠方式塌缩的折叠机构，其包括以下布置中的至少一种：(i)线穿线通过臂部；和(ii)基部和支柱由弹性材料形成；而不脱离上述方面。In other words, the device for causing the arm to collapse toward the base in a folding manner may also be considered as a mechanism for causing the arm to collapse toward the base in a folding manner and/or a folding mechanism configured to collapse the arm toward the base in a folding manner, which includes at least one of the following arrangements: (i) a wire is threaded through the arm; and (ii) the base and the support are formed of an elastic material; without departing from the above aspects.
可以使用任何合适的紧固装置，将人造线通过基部连接到织物体。Any suitable fastening means may be used to connect the synthetic thread to the fabric body through the base.
拉伸线和/或人造线可以由缝合材料形成。The stretch threads and/or artificial threads may be formed from suture material.
每个臂部可包括端盖，端盖固定在每个臂部的远离基部的一端。每个端盖可包括开口，该开口构造成接合用于将织物体植入身体组织中的丝线引导构件。端盖可视为管状盖构件。Each arm may include an end cap fixed to an end of each arm away from the base. Each end cap may include an opening configured to engage a wire guide member for implanting the fabric body into body tissue. The end cap may be considered a tubular cap member.
通过提供包括被构造成接合丝线引导构件用于植入织物体的开口的端盖，可以操纵臂部，使其能够被植入通过身体组织。例如，丝线引导构件可以沿他们的接合方向推动臂部，使得臂部穿过身体组织。By providing an end cap including an opening configured to engage a wire guide member for implanting the fabric body, the arm can be manipulated so that it can be implanted through body tissue. For example, the wire guide member can push the arm along their engagement direction so that the arm passes through body tissue.
此外，通过使用引导臂部穿过身体组织的丝线引导构件，而不是使用从其部署臂部的针，每个臂部所穿过的身体组织中的孔不需要与针或包含臂部的其他导管穿过所需的孔一样大。也就是说，开口的尺寸仅受织物体的几何形状的限制。相比之下，通过针植入所需的开口的尺寸将始终受针的尺寸限制，而针的尺寸始终大于要部署的构件。这可以减少植入部位的创伤。Furthermore, by using a wire guide member to guide the arm through body tissue, rather than a needle from which the arm is deployed, the hole in the body tissue through which each arm passes does not need to be as large as the hole required for the needle or other conduit containing the arm to pass through. That is, the size of the opening is limited only by the geometry of the fabric body. In contrast, the size of the opening required for implantation by needle will always be limited by the size of the needle, which is always larger than the member to be deployed. This can reduce trauma to the implantation site.
锚固系统可包括拉伸线(例如如上所述)。拉伸线可固定到端盖并从其中央部分延伸，使得在使用中，端盖被配置成在植入身体软组织中时并且在线沿远离组织的表面的方向穿过组织时在拉力的作用下，在与身体组织的表面平行的平面中延伸。The anchoring system may include a tension wire (e.g., as described above). The tension wire may be secured to the end cap and extend from a central portion thereof such that, in use, the end cap is configured to extend in a plane parallel to the surface of the body tissue when implanted in soft body tissue and under tension as the wire passes through the tissue in a direction away from the surface of the tissue.
端盖可包括第一端、远离第一端的第二端以及在第一端和第二端之间延伸的侧壁。开口可位于端盖的第一端处。端盖的第二端可限定管状盖构件的末端，该末端被配置成用于插入身体软组织中。The end cap may include a first end, a second end distal to the first end, and a sidewall extending between the first end and the second end. The opening may be located at the first end of the end cap. The second end of the end cap may define a distal end of the tubular cover member configured for insertion into soft body tissue.
端盖的中央部分可被认为是端盖的位于端盖的几何中心(即，沿端盖的纵向轴线的中心点)周围的部分，该部分包括：小于端盖长度的30％；小于端盖长度的40％；小于端盖长度50％；或小于端盖长度的60％。端盖的中央部分可以被被认为包括端盖长度的“中间三分之一”。换句话说，端盖的中央部分可以包括端盖上的比第一端或第二端更靠近端盖的几何中心的任意点。The central portion of the end cap may be considered to be the portion of the end cap located about the geometric center of the end cap (i.e., the center point along the longitudinal axis of the end cap) that includes: less than 30% of the length of the end cap; less than 40% of the length of the end cap; less than 50% of the length of the end cap; or less than 60% of the length of the end cap. The central portion of the end cap may be considered to include the "middle third" of the length of the end cap. In other words, the central portion of the end cap may include any point on the end cap that is closer to the geometric center of the end cap than the first end or the second end.
在一些示例中，该线可以基本上居中延伸，即，基本上从端盖的中心居中延伸(例如，与端盖的几何中心一致)。In some examples, the line may extend substantially centrally, ie, extend substantially centrally from the center of the end cap (eg, coincident with the geometric center of the end cap).
在其他示例中，该线可以不对称地延伸，并且因此可以从沿着端盖的点更朝向端盖的第一端或第二端延伸(但仍在端盖的中央部分内)。In other examples, the line may extend asymmetrically, and thus may extend from a point along the end cap more toward the first end or the second end of the end cap (but still within the central portion of the end cap).
例如，非对称布置可以将线从端盖延伸的点定位在远离开口的位置(即朝向端盖的末端)。使线从位于朝向端盖的末端的点延伸可以便于对端盖施加扭矩以将其置于“T”构型中。然而，在其他优选示例中，线从端盖延伸的点定位在靠近开口的位置(即朝向端盖的开口)。当端盖在线的拉力下在与身体组织的表面/褶层平行的平面中延伸时，使线从位于朝向端盖的开口的点延伸可以更好地分配端盖施加的接触力。端盖可以具有越靠近末端越小的投影面积(例如，由于末端的锥度和/或斜面)。端盖可以具有越靠近开口越大的投影面积(例如由于缺乏锥度/端盖朝向开口较宽)。因此，将线从端盖延伸的点布置成靠近于开口可以使得，当管状盖构件在与身体组织的表面/褶层平行的平面中延伸时，由管状盖构件的轮廓施加的接触力被更均衡地分布。For example, an asymmetric arrangement can position the point from which the line extends from the end cap away from the opening (i.e., toward the end of the end cap). Extending the line from a point located toward the end of the end cap can facilitate applying torque to the end cap to place it in a "T" configuration. However, in other preferred examples, the point from which the line extends from the end cap is positioned near the opening (i.e., toward the opening of the end cap). When the end cap extends in a plane parallel to the surface/fold of the body tissue under the tension of the line, extending the line from a point located toward the opening of the end cap can better distribute the contact force applied by the end cap. The end cap can have a smaller projected area closer to the end (e.g., due to the taper and/or bevel of the end). The end cap can have a larger projected area closer to the opening (e.g., due to the lack of taper/the end cap is wider toward the opening). Therefore, arranging the point from which the line extends from the end cap close to the opening can make it possible for the contact force applied by the profile of the tubular cover member to be more evenly distributed when the tubular cover member extends in a plane parallel to the surface/fold of the body tissue.
因此，如上所述，该线可以从其所固定到的端盖的中央部分延伸：基本上在端盖的中心处；朝向端盖的第一端；或者朝向端盖的第二端。Thus, as described above, the wire may extend from a central portion of the end cap to which it is secured: substantially at the center of the end cap; towards the first end of the end cap; or towards the second end of the end cap.
线的端部固定到端盖的方式可以覆盖端盖的长度。例如，线的端部的一定长度可以周向缠绕在端盖或其一部分周围，并且该长度线的还沿着端盖的轴向长度延伸(即以螺旋或盘绕的方式)。从端盖延伸的线可以从该盘绕的线部分延伸。或者，固定到端盖或其一部分的线的端部的一定长度可以基本沿着端盖或其一部分轴向延伸。从端盖延伸的线可以从该长度的线延伸。The end of the wire may be secured to the end cap in a manner that covers the length of the end cap. For example, a length of the end of the wire may be wrapped circumferentially around the end cap or a portion thereof, and this length of wire may also extend along the axial length of the end cap (i.e. in a spiral or coiled manner). The wire extending from the end cap may extend from the coiled wire portion. Alternatively, a length of the end of the wire secured to the end cap or a portion thereof may extend substantially axially along the end cap or a portion thereof. The wire extending from the end cap may extend from this length of wire.
线的端部可以固定到端盖的中央部分。但是，只要线从端盖的中央部分延伸，线的该端部不必被限制为固定到端盖的中央部分。因此，替代地，软组织锚固系统可以被认为使得线的一端被固定到端盖的中央部分，这里提到的线的一端是指线的最初从端盖延伸的部分(即，是线的确定在使用中线可以将拉力施加到端盖的沿着端盖的位置的“端部”部分)。The end of the wire can be secured to the central portion of the end cap. However, as long as the wire extends from the central portion of the end cap, the end of the wire is not necessarily limited to being secured to the central portion of the end cap. Therefore, alternatively, the soft tissue anchoring system can be considered such that one end of the wire is secured to the central portion of the end cap, where the one end of the wire referred to here refers to the portion of the wire that initially extends from the end cap (i.e., the "end" portion of the wire that determines the position along the end cap where the wire can apply tension to the end cap in use).
每个端盖可包括外管状构件和内管状构件，其中，内管状构件被配置成由外管状构件接收。也就是说，内管状构件可嵌套在外管状构件内和/或与外管状构件同心。内管状构件可限定被配置成接合丝线引导构件的开口。Each end cap may include an outer tubular member and an inner tubular member, wherein the inner tubular member is configured to be received by the outer tubular member. That is, the inner tubular member may be nested in the outer tubular member and/or concentric with the outer tubular member. The inner tubular member may define an opening configured to engage the wire guide member.
外管状构件和内管状构件可构造成将相应臂部的远端夹置、压接和/或夹紧在其间，从而将端盖固定到臂部。可另外或替代地使用粘合剂以将端盖固定到臂部。The outer tubular member and the inner tubular member may be configured to sandwich, crimp and/or clamp the distal ends of the respective arms therebetween, thereby securing the end cap to the arms. An adhesive may additionally or alternatively be used to secure the end cap to the arms.
在一种布置中，外管状构件和内管状构件各自限定了沿其整个长度延伸的开口，即它们沿其整个长度是空心的。内管状构件可以配置为允许丝线引导构件的刺穿部分穿过其中，并且还可以配置为抵接丝线引导构件的肩部或凸起部分。包括刺穿部分的丝线引导构件可以被视为刺穿丝线引导构件，该刺穿部分配置为在植入锚固系统期间刺穿身体组织。In one arrangement, the outer tubular member and the inner tubular member each define an opening extending along their entire length, i.e., they are hollow along their entire length. The inner tubular member can be configured to allow the piercing portion of the wire guide member to pass therethrough, and can also be configured to abut against a shoulder or raised portion of the wire guide member. The wire guide member including the piercing portion can be considered as a piercing wire guide member, which is configured to pierce body tissue during implantation of the anchoring system.
通过使刺穿丝线引导构件能够穿过内管状构件，端盖可包括钝的和/或圆形的末端，同时仍能够在植入锚固系统期间刺穿身体组织。此外，通过提供构造成抵接丝线引导构件的肩部或凸起部分的内管状构件，可实现通过刺穿丝线引导构件操纵臂部的适当接触。By enabling the piercing wire guide member to pass through the inner tubular member, the end cap may include a blunt and/or rounded tip while still being able to pierce body tissue during implantation of the anchoring system. In addition, by providing an inner tubular member configured to abut a shoulder or raised portion of the wire guide member, appropriate contact of the manipulation arm by the piercing wire guide member may be achieved.
此外，使用适合与刺穿丝线引导构件一起使用的端盖可以进一步减少植入部位处经受的创伤，因为丝线引导构件的刺穿部分可以具有比例如用于形成用于植入的切口的空心针构件小的直径。Additionally, use of an end cap adapted for use with a piercing wire guiding member may further reduce trauma experienced at the implantation site, as the piercing portion of the wire guiding member may have a smaller diameter than, for example, a hollow needle member used to make an incision for implantation.
内管状构件可延伸出外管状构件，并可限定端盖的末端。这种布置导致在内管状构件和外管状构件之间，在端盖末端处形成阶梯过渡，这可便于端盖在植入过程中更平稳地穿过身体组织。The inner tubular member can extend out of the outer tubular member and can define the end of the end cap. This arrangement results in a stepped transition between the inner tubular member and the outer tubular member at the end of the end cap, which can facilitate smoother passage of the end cap through body tissue during implantation.
或者，外管状构件可包括位于端盖的末端处的锥形部分。也就是说，端盖的末端可由外管状构件限定，而内管状构件的端部可包含在外管状构件内。这种布置导致端盖的末端与外管状构件之间、在端盖的末端处的连续过渡，这可便于端盖在植入过程中更平稳地穿过身体组织。Alternatively, the outer tubular member may include a tapered portion at the end of the end cap. That is, the end of the end cap may be defined by the outer tubular member, and the end of the inner tubular member may be contained within the outer tubular member. This arrangement results in a continuous transition between the end of the end cap and the outer tubular member at the end of the end cap, which may facilitate smoother passage of the end cap through body tissue during implantation.
内管状构件可包括喇叭形入口，该入口界定了开口，该开口构造成与丝线引导构件接合。喇叭形入口应理解为内管状构件的限定开口的一部分，在该部分中，内管状构件的圆周范围相对于内管状构件的其余部分增大。The inner tubular member may comprise a flared inlet defining an opening configured to engage with the wire guiding member.A flared inlet is understood to be a portion of the inner tubular member defining an opening in which the circumferential extent of the inner tubular member is increased relative to the remainder of the inner tubular member.
优选地，喇叭形入口包括倾斜面，以便于将丝线引导构件引导到内管状构件中。当丝线引导构件在植入之前未被管状盖构件的开口接收时，这种布置可能是优选的。Preferably, the flared inlet comprises an inclined surface to facilitate guiding the wire guiding member into the inner tubular member.Such an arrangement may be preferred when the wire guiding member is not received by the opening of the tubular cover member prior to implantation.
喇叭形入口可配置为与丝线引导构件的相应部分配合匹配。也就是说，喇叭形入口可与穿刺丝线引导构件的肩部区域或凸起部分的形状互补。喇叭形入口的倾斜面可与丝线引导构件的肩部区域或凸起部分互补。喇叭形入口可在植入织物体期间改善丝线引导构件与端盖之间的接触。The trumpet-shaped inlet can be configured to match the corresponding part of the wire guide member. In other words, the trumpet-shaped inlet can complement the shape of the shoulder area or the raised part of the puncture wire guide member. The inclined surface of the trumpet-shaped inlet can complement the shoulder area or the raised part of the wire guide member. The trumpet-shaped inlet can improve the contact between the wire guide member and the end cap during the implantation of the fabric body.
内管状构件可通过压配合和/或匹配凹口保持在外管状构件内。内管状盖构件还可或可替代地通过压接操作保持在外管状构件内。The inner tubular member may be retained within the outer tubular member by a press fit and/or matching recesses. The inner tubular cover member may also or alternatively be retained within the outer tubular member by a crimping operation.
喇叭形入口可配置为将内管状构件定位在外管状构件内。内管状构件靠近开口的一端可通过匹配凹口、压配合和/或压接连接与外管状构件配合。喇叭形入口可在内管状构件和外管状构件之间提供压配合。内管状构件远离开口的一端也可经由匹配凹口、压配合和/或压接连接与外管状构件配合。提供至少两个保持区域或点可提高内管状构件在外管状构件内的保持强度。The flared inlet can be configured to position the inner tubular member within the outer tubular member. The end of the inner tubular member near the opening can be mated with the outer tubular member via a matching notch, a press fit, and/or a crimp connection. The flared inlet can provide a press fit between the inner tubular member and the outer tubular member. The end of the inner tubular member away from the opening can also be mated with the outer tubular member via a matching notch, a press fit, and/or a crimp connection. Providing at least two retention areas or points can increase the retention strength of the inner tubular member within the outer tubular member.
外管状构件可包括肩部区域，该肩部区域构造成与内管状构件配合，远离开口。这可便于将内管状构件定位在外管状构件内，使得由内管状构件限定的开口适当地定位在管状盖构件的端部。The outer tubular member may include a shoulder region configured to cooperate with the inner tubular member, away from the opening. This may facilitate positioning the inner tubular member within the outer tubular member so that the opening defined by the inner tubular member is properly positioned at the end of the tubular cover member.
端盖的远离基部的末端可以是钝的和/或圆形的末端。通过具有钝的和/或圆形的末端，一旦植入或以其它方式，由端盖引起的身体组织撕裂和/或进一步创伤的风险被减轻。The end of the end cap away from the base can be a blunt and/or rounded end. By having a blunt and/or rounded end, once implanted or otherwise, the risk of body tissue tearing and/or further trauma caused by the end cap is mitigated.
端盖的末端可以位于端盖的远离臂部的端部处(即，位于端盖的远离被构造成接合丝线引导构件的开口的端部处)。The tip of the end cap may be located at an end of the end cap distal to the arm portion (ie, at an end of the end cap distal to the opening configured to engage the wire guiding member).
在替代布置中，每个端盖可包括尖头末端。尖头末端可配置为刺穿身体组织，例如，当丝线引导构件向端盖施加动力时，尖头末端可刺穿身体组织。In an alternative arrangement, each end cap may include a pointed tip. The pointed tip may be configured to pierce body tissue, for example, when the wire guiding member applies power to the end cap, the pointed tip may pierce body tissue.
端盖的末端可以位于端盖的远离臂部的端部处(即，位于端盖的远离被构造成接合丝线引导构件的开口的端部处)。The tip of the end cap may be located at an end of the end cap distal to the arm portion (ie, at an end of the end cap distal to the opening configured to engage the wire guiding member).
尖头末端末端可包括锥形末端，即，具有绕管状盖构件的纵向轴线旋转对称性的尖头末端。The pointed tip may comprise a tapered tip, ie a pointed tip having rotational symmetry about the longitudinal axis of the tubular cover member.
或者，尖头末端可具有绕管状盖构件的纵向轴线的旋转非对称几何形状。使用用于尖头末端的旋转非对称的末端几何形状可使尖头末端具有用于其尖头的平面(即，其剪切边缘的平面)的较高的拔模角。使用具有较高拔模角的尖头末端可减小尖头末端刺穿身体软组织所需的力，从而减小植入期间在植入部位处经历的创伤。Alternatively, the pointed tip may have a rotationally asymmetric geometry about the longitudinal axis of the tubular cover member. Using a rotationally asymmetric tip geometry for the pointed tip may allow the pointed tip to have a higher draft angle for the plane of its tip (i.e., the plane of its shearing edge). Using a pointed tip with a higher draft angle may reduce the force required for the pointed tip to penetrate soft body tissue, thereby reducing the trauma experienced at the implantation site during implantation.
为此，尖头末端可包括斜面。斜面应理解为限定单个平面，即斜面的面被磨削(例如，研磨面)或以其他方式形成的平面。To this end, the pointed tip may include a bevel. A bevel is understood to define a single plane, ie a plane where the face of the bevel is ground (eg, lapped) or otherwise formed.
斜面可限定尖头末端的面。斜面相对于管状盖构件的径向平面的拔模角可大于50°、大于60°、大于70°或大于80°。斜面相对于管状盖构件的纵向轴线的拔模角可小于10°、小于20°、小于30°或小于40°。The bevel may define a face of a pointed tip. The draft angle of the bevel relative to a radial plane of the tubular cover member may be greater than 50°, greater than 60°, greater than 70°, or greater than 80°. The draft angle of the bevel relative to the longitudinal axis of the tubular cover member may be less than 10°, less than 20°, less than 30°, or less than 40°.
尖头末端可包括单个斜面，并可描述为斜面末端或凿子末端。The pointed end may include a single bevel and may be described as a bevel end or a chisel end.
或者，尖头末端除了斜面外还可包括两个尖拱平面。尖拱平面可与斜面侧面相接，优选是对称地。斜面和每个尖拱平面应理解为限定各自的平面(例如研磨平面)。这种末端几何形状可描述为尖拱状尖头末端。因此，尖头末端可以是尖拱状尖头末端。Alternatively, the pointed end may include two pointed arch planes in addition to the bevel. The pointed arch planes may be connected to the bevel side, preferably symmetrically. The bevel and each pointed arch plane should be understood to define a respective plane (e.g., a grinding plane). This end geometry can be described as a pointed arch-shaped pointed end. Therefore, the pointed end can be a pointed arch-shaped pointed end.
在配置为接收丝线引导构件的开口包括盲孔或盲洞的布置中，尖头末端可被视为尖端探针。在配置为接收丝线引导构件的开口完全延伸穿过管状盖构件的布置中(这种布置便于制造管状盖构件)，尖头末端可被视为尖端套管。In an arrangement where the opening configured to receive the wire guide member comprises a blind hole or blind aperture, the pointed tip may be considered a tip probe. In an arrangement where the opening configured to receive the wire guide member extends completely through the tubular cover member (such an arrangement facilitates the manufacture of the tubular cover member), the pointed tip may be considered a tip cannula.
尖头末端可为可伸缩的尖头末端。端盖的末端可具有：第一位置，在该位置中，末端为尖头末端，即，尖头末端被部署；并且可具有第二位置，在该位置中，末端为钝头和/或圆头末端，即，尖头末端被收回。第二位置可为可伸缩的尖头末端的静止位置。可通过丝线引导构件与端盖的接合将可伸缩的尖头末端从第二位置推至第一位置。The pointed tip may be a retractable pointed tip. The tip of the end cap may have a first position in which the tip is a pointed tip, i.e., the pointed tip is deployed, and a second position in which the tip is a blunt and/or rounded tip, i.e., the pointed tip is retracted. The second position may be a rest position of the retractable pointed tip. The retractable pointed tip may be pushed from the second position to the first position by engagement of the wire guide member with the end cap.
外管状构件可以限定尖头末端。如果尖头末端永久存在，则内管状构件可以包括接收丝线引导构件的盲孔。如果尖头末端是可伸缩的尖头末端，则内管状构件可以是空心的，使得丝线引导构件可以致动可伸缩的尖头末端和/或任何合适的部署机构。The outer tubular member may define a pointed end. If the pointed end is permanent, the inner tubular member may include a blind hole to receive the wire guide member. If the pointed end is a retractable pointed end, the inner tubular member may be hollow so that the wire guide member can actuate the retractable pointed end and/or any suitable deployment mechanism.
拉伸线可固定到端盖上。每个端盖可配置为在内管状构件和外管状构件之间接收拉伸线。拉伸线可以通过压接、压模、夹紧、粘合和/或将拉伸线夹在内管状构件和外管状构件之间来固定到每个端盖。拉伸线也可通过将拉伸线缝合或系在管状构件上来固定。The stretch wire may be secured to the end caps. Each end cap may be configured to receive the stretch wire between the inner tubular member and the outer tubular member. The stretch wire may be secured to each end cap by crimping, compression molding, clamping, bonding, and/or sandwiching the stretch wire between the inner tubular member and the outer tubular member. The stretch wire may also be secured by sewing or tying the stretch wire to the tubular member.
外管状构件可以包括形成在侧壁中的开口，该开口构造成接收拉伸线。该开口可形成在端盖的中央区域，并且更优选地，该开口可形成在朝向端盖的末端处。The outer tubular member may include an opening formed in the side wall, the opening being configured to receive the tensile wire. The opening may be formed in a central region of the end cap, and more preferably, the opening may be formed at a distal end toward the end cap.
每个端盖可配置为在植入和/或收回U形织物体期间与相应的臂部共线延伸。每个端盖可配置为在拉力施加到拉伸线上时与相应的臂部的每个褶层的平面平行延伸。Each end cap may be configured to extend in line with the corresponding arm during implantation and/or retrieval of the U-shaped fabric body. Each end cap may be configured to extend parallel to the plane of each fold of the corresponding arm when tension is applied to the tension wire.
由于臂部可以固定在端盖的靠近臂部的一端，并且由于拉伸线可以固定在端盖的远离臂部的中心区域和/或朝向端盖的末端，因此由于臂部和/或拉伸线而施加的拉力可以导致扭矩作用在端盖上。Since the arm may be fixed to one end of the end cap proximal to the arm, and since the tension wire may be fixed to a central region of the end cap away from the arm and/or toward the end of the end cap, the tension applied by the arm and/or the tension wire may cause a torque to act on the end cap.
因此，当丝线引导构件与端盖接合时，端盖将伸直并与臂部共线地延伸。这可有助于将织物体的臂部植入身体组织中。当拉伸线受到拉力并因此使臂部折叠而塌缩时，拉伸线可转动端盖使之与臂部的褶层平行，从而与臂部所折叠靠着的身体组织的表面平行。这可有助于将臂部固定到身体组织，并且还可最小化植入期间从身体组织突出的端盖的轮廓。例如，端盖可转动成垂直于拉伸线而处于“T”形构型，在该构型中，拉伸线垂直于身体组织的表面，并且端盖的长度平行于身体组织的表面，从而防止端盖穿过身体组织的移动。当从身体组织回收织物体部分时，例如通过从远离端盖的方向拉动，作用于臂部的拉力可使端盖从平行位置自动复位，使得它们在回收过程中与臂部共线延伸。因此，通过将臂部在其端部处联接到端盖，来自臂部的拉力将倾向于(例如从上述的“T”形构型)拉直端盖，使其与臂部对齐，从而与穿过身体组织的孔对齐。这可便于回收并尽量减少回收过程中身体组织受到的任何创伤。Therefore, when the wire guide member is engaged with the end cap, the end cap will straighten and extend in line with the arm. This can help implant the arm of the fabric body into the body tissue. When the stretch line is subjected to tension and thus folds and collapses the arm, the stretch line can rotate the end cap to make it parallel to the fold of the arm, thereby parallel to the surface of the body tissue against which the arm is folded. This can help fix the arm to the body tissue, and can also minimize the profile of the end cap protruding from the body tissue during implantation. For example, the end cap can be rotated to be perpendicular to the stretch line and in a "T" configuration, in which the stretch line is perpendicular to the surface of the body tissue, and the length of the end cap is parallel to the surface of the body tissue, thereby preventing the end cap from moving through the body tissue. When the fabric body portion is recovered from the body tissue, for example, by pulling from a direction away from the end cap, the tension acting on the arm can automatically reset the end cap from a parallel position, so that they extend in line with the arm during the recovery process. Thus, by coupling the arms at their ends to the end caps, the pulling force from the arms will tend to straighten the end caps (e.g., from the "T" configuration described above) into alignment with the arms and thus with the holes through the body tissue. This can facilitate retrieval and minimize any trauma to the body tissue during the retrieval process.
端盖可以由能够保持其形状的合适的刚性生物相容性材料制成，例如不锈钢、钛、工程塑料或镍钛合金。端盖可以是单个部件(例如，空心管)，其中，拉伸线被系绑或固定至管。端盖可以通过激光切割或加工镍钛合金或不锈钢而形成为单个部件。The end cap can be made of a suitable rigid biocompatible material that can retain its shape, such as stainless steel, titanium, engineered plastics, or nitinol. The end cap can be a single component (e.g., a hollow tube) with the tensile wire tied or secured to the tube. The end cap can be formed as a single component by laser cutting or machining nitinol or stainless steel.
每个端盖的外管状构件可以包括凹槽、通道、孔口或其他合适的特征，用于在外管状构件和内管状构件之间引导臂部。该凹槽、通道、孔口或其他合适的特征可与用于线的孔口或开口周向对齐地形成，并且还可以在构造成接收丝线引导构件的开口处或朝向该开口而形成。使线和臂部彼此对齐可提高软组织锚固系统在植入身体软组织中时的稳定性。The outer tubular member of each end cap may include a groove, channel, orifice or other suitable feature for guiding the arm between the outer tubular member and the inner tubular member. The groove, channel, orifice or other suitable feature may be formed in circumferential alignment with the orifice or opening for the wire, and may also be formed at or toward the opening configured to receive the wire guide member. Aligning the wire and the arm with each other may improve the stability of the soft tissue anchoring system when implanted in the body soft tissue.
将臂部朝向端盖的开口固定并且将线固定在管状盖构件的中央部分处可以便于线在拉力作用下向端盖施加扭矩，从而使端盖在植入时平放靠着身体软组织。Securing the arms toward the opening of the end cap and securing the wire at the central portion of the tubular cap member may facilitate the wire applying torque to the end cap under tension, thereby causing the end cap to lie flat against soft body tissue when implanted.
将臂部固定在端盖的开口处和/或接近端盖的开口处也可便于端盖的回收。例如，在回收软组织锚固系统时，可放松线中的拉力。然后可拉动臂部/织物体以施加拉力。该拉力可导致扭矩被施加到端盖，从而使得端盖转动，使得端盖在垂直于身体软组织的表面的平面中延伸(例如，使得其与线共线地延伸)。然后可拉动和/或引导管状盖构件穿过身体软组织。因此，这种布置可便于在回收软组织锚固系统期间回收端盖，同时还可以最大程度地减少回收期间身体组织所经受的任何创伤。Securing the arm at the opening of the end cap and/or near the opening of the end cap can also facilitate the recovery of the end cap. For example, when recovering the soft tissue anchoring system, the tension in the line can be relaxed. The arm/fabric body can then be pulled to apply the tension. The tension can cause a torque to be applied to the end cap, thereby causing the end cap to rotate so that the end cap extends in a plane perpendicular to the surface of the body's soft tissue (for example, so that it extends colinearly with the line). The tubular cover member can then be pulled and/or guided through the body's soft tissue. Therefore, this arrangement can facilitate the recovery of the end cap during the recovery of the soft tissue anchoring system, while also minimizing any trauma to the body tissue during the recovery.
或者，形成于外管状构件的侧壁中的用于接收线的孔口也可接收臂部。因此，臂部和线到端盖的固定可同时进行。Alternatively, the aperture formed in the side wall of the outer tubular member for receiving the wire may also receive the arm. Thus, the fixing of the arm and the wire to the end cap may be performed simultaneously.
替代地，并且如在植入前丝线引导构件由端盖的开口接收的布置中可能是优选的，外管状构件可以不包括用于在外管状构件和内管状构件之间引导臂部的通道和/或限定被构造成用于接收丝线引导构件的开口的喇叭形入口。这可以使得端盖变得更短和/或更薄(即直径更窄)，因此更紧凑，适用于在植入期间不需要将丝线引导构件引导到与端盖接合的布置。Alternatively, and as may be preferred in arrangements where the wire guide member is received by an opening in the end cap prior to implantation, the outer tubular member may not include a passage for guiding the arm portion between the outer tubular member and the inner tubular member and/or define a trumpet-shaped inlet configured to receive an opening of the wire guide member. This may allow the end cap to be shorter and/or thinner (i.e., narrower in diameter), and therefore more compact, suitable for arrangements where the wire guide member does not need to be guided into engagement with the end cap during implantation.
织物体可以由单层织物或多层织物形成。在这种情况下，织物可以被认为是由细丝或细丝状物编织而成的材料。一种可能的材料是聚酯织物，其他材料包括PET、UHMPE、EPTFE、PTFE和类似材料的织物。织物体可以由任何合适的柔性、顺应性和生物相容性材料制成。织物体可以通过激光切割现有材料或任何其他合适的制造技术来形成。The fabric body can be formed of a single layer of fabric or a multilayer of fabric. In this case, the fabric can be considered to be a material woven from filaments or filaments. One possible material is polyester fabric, and other materials include fabrics of PET, UHMPE, EPTFE, PTFE and similar materials. The fabric body can be made of any suitable flexible, compliant and biocompatible material. The fabric body can be formed by laser cutting existing materials or any other suitable manufacturing technology.
在本实施例中，使用至少两个臂部，U形体之所以被称为U形体，是因为基部和两个臂部形成了U形。然而，应理解，这仅指具有两个臂部的织物体的单元结构，如果存在更多臂部，形状将有所不同。例如，包括三个臂部的织物体可被认为是W形体，其中，W形体包括两个U形单元。因此，锚固系统可以包括具有多个U形单元的织物体，从而获得适用于软组织锚固系统的所需用途的尺寸的织物体。In the present embodiment, at least two arms are used, and the U-shaped body is so called because the base and the two arms form a U-shape. However, it should be understood that this refers only to the unit structure of the fabric body with two arms, and if there are more arms, the shape will be different. For example, a fabric body including three arms can be considered as a W-shaped body, wherein the W-shaped body includes two U-shaped units. Therefore, the anchoring system can include a fabric body with a plurality of U-shaped units, thereby obtaining a fabric body of a size suitable for the desired use of the soft tissue anchoring system.
基部可以是织物体的最宽部分。也就是说，基部可以限定织物体的最大宽度。The base can be the widest part of the fabric body. In other words, the base can define the maximum width of the fabric body.
基部可以包括一对翼部。翼部可延伸得比臂部的最外边缘宽。The base may include a pair of wings. The wings may extend wider than the outermost edges of the arms.
通过提供宽度增大的基部，或者至少比臂部宽的基部，基部可以被配置为在植入身体组织时为织物体提供更大的侧向支撑。By providing a base portion of increased width, or at least a base portion that is wider than the arm portions, the base portion may be configured to provide greater lateral support to the fabric body when implanted in body tissue.
当使用锚时，基部可以植在瓣叶的心房侧上，心跳期间需要保持该侧。在这种情况下，增加用于心房侧位置的侧向支撑有利于实现瓣叶的宽阔支撑区域。如果基部位于心房侧，则臂部位于心室侧。它们的作用是将锚固系统保持到位并提供一些支撑，而心房侧部分(基部)在心脏收缩(心缩期)期间更积极地承受血流对瓣叶施加的力。When using the anchor, the base can be implanted on the atrial side of the leaflet, which side needs to be maintained during the heartbeat. In this case, the addition of lateral support for the atrial side position is beneficial to achieve a wide support area for the leaflet. If the base is located on the atrial side, the arms are located on the ventricular side. Their role is to hold the anchoring system in place and provide some support, while the atrial side part (base) is more actively subjected to the forces exerted by the blood flow on the leaflet during the contraction of the heart (systole).
基部可以包括形状保持构件。形状保持构件可被配置为增加基部的刚度。形状保持构件可配置为保持基部的平面范围，或与瓣叶/解剖结构的形状相符的3D形状。The base may include a shape-retaining member. The shape-retaining member may be configured to increase the stiffness of the base. The shape-retaining member may be configured to maintain the planar extent of the base, or a 3D shape that conforms to the shape of the leaflets/anatomical structure.
通过使用形状保持构件加固基部，基部能够为植入有织物体的身体组织提供更大的侧向支撑。此外，当提供有形状保持构件时，植入过程中织物体在保持人造线时所经受的拉力可以更均匀地分布在基部上。这可以提高植入时织物体的稳定性。By reinforcing the base with a shape-retaining member, the base can provide greater lateral support to the body tissue in which the fabric body is implanted. In addition, when provided with a shape-retaining member, the tensile force experienced by the fabric body when holding the artificial thread during implantation can be more evenly distributed on the base. This can improve the stability of the fabric body when implanted.
形状保持构件可以由弹性材料形成。基部可以包括折叠构型和展开构型，其中，形状保持构件被配置成在移除约束力时将基部从折叠构型推至展开构型。基部在展开构型中可以是基本平坦的。The shape-retaining member may be formed of an elastic material. The base may include a folded configuration and an expanded configuration, wherein the shape-retaining member is configured to urge the base from the folded configuration to the expanded configuration when the restraining force is removed. The base may be substantially flat in the expanded configuration.
形状保持构件可以嵌入基部的层中、与基部的各层交织和/或夹在基部的各层之间。The shape-retaining member may be embedded in, interwoven with, and/or sandwiched between layers of the base.
基部可以通过将织物体的一部分向后折叠在其自身上并将形状保持构件夹在它们中间来形成。形状保持构件和/或织物体的折叠部分可以通过粘合剂、超声波焊接、缝合或其他合适的固定方式固定到位。The base can be formed by folding a portion of the fabric body back on itself and sandwiching the shape-retaining member between them. The shape-retaining member and/or the folded portion of the fabric body can be fixed in place by adhesive, ultrasonic welding, sewing or other suitable fixing means.
形状保持构件可以包括荧光标记。荧光标记可以在植入和/或回收期间通过成像帮助定位织物体。The shape-retaining member may include a fluorescent marker. The fluorescent marker may aid in locating the fabric body by imaging during implantation and/or retrieval.
形状保持构件可以由诸如不锈钢、钛或镍钛合金之类的形状保持金属形成。形状保持构件可以通过激光切割形成，或者通过对由类似材料制成的丝线进行成形而形成。The shape-retaining member may be formed of a shape-retaining metal such as stainless steel, titanium, or nickel-titanium alloy. The shape-retaining member may be formed by laser cutting, or by shaping a wire made of a similar material.
基部可以提供用于在植入后收回织物体的表面。可以通过抓住基部并将基部拉离身体组织而将臂部从身体组织中拉出来收回U形织物体。形状保持构件可以提高收回的简易性，因为形状保持构件可帮助分散收回期间基部所经受的拉力。The base can provide a surface for retracting the fabric body after implantation. The U-shaped fabric body can be retracted by grasping the base and pulling the base away from the body tissue and pulling the arms out of the body tissue. The shape-retaining member can improve the ease of retraction because the shape-retaining member can help distribute the tension experienced by the base during retraction.
基部中的形状保持构件还可以防止臂部在部署时过度延伸穿过瓣叶，因为它可以在臂部被导丝拉过组织时充当止动件-这样，基部与形状保持构件相结合可以限制部署线在部署过程中可以延伸的距离。The shape-retaining member in the base can also prevent the arms from overextending through the leaflets during deployment because it can act as a stop as the arms are pulled through tissue by the guidewire - thus, the base in combination with the shape-retaining member can limit the distance the deployment wire can extend during deployment.
基部可被配置为由圈套夹持，并且可选地可使用荧光标记来定位基部。例如，圈套可在臂部最初从基部延伸的位置环绕臂部，在植入时与基部位于身体组织的同一侧。然后，可收紧圈套，使得在收回时，圈套夹持基部。该对翼部可提供基部的加宽表面，基部可通过该加宽表面被圈套夹持。The base can be configured to be gripped by a snare, and fluorescent markings can optionally be used to locate the base. For example, the snare can be wrapped around the arm at the location where the arm initially extends from the base, on the same side of the body tissue as the base when implanted. The snare can then be tightened so that when retracted, the snare grips the base. The pair of wings can provide a widened surface of the base by which the base can be gripped by the snare.
臂部可以包括在基部和每个臂部之间延伸的窄腰部。在植入时，窄腰部可与身体软组织对准，使得窄腰部在植入部位处被身体软组织环绕。窄腰部可被构造的比软组织锚固系统将植入的身体软组织的厚度长。例如，窄腰部的长度可以是：大于至少1毫米；大于至少2毫米；或大于至少3毫米。窄腰部的长度可以在1毫米至3毫米之间。每个窄腰部可同样被视为相应臂部的一部分，使得每个臂部在臂部的靠近基部的端部处包括窄腰部，或者可替代地被视为其自身的相应部分，如上所述。窄腰部可稳定基部在身体组织附近的植入。该特征还可有助于在拉紧拉伸线之前将臂部保持就位。The arm portion may include a narrow waist extending between the base and each arm portion. When implanted, the narrow waist may be aligned with body soft tissue so that the narrow waist is surrounded by body soft tissue at the implantation site. The narrow waist may be constructed to be longer than the thickness of the body soft tissue into which the soft tissue anchoring system is to be implanted. For example, the length of the narrow waist may be: greater than at least 1 mm; greater than at least 2 mm; or greater than at least 3 mm. The length of the narrow waist may be between 1 mm and 3 mm. Each narrow waist may also be considered as a part of the corresponding arm portion, such that each arm portion includes a narrow waist at the end of the arm portion near the base, or may alternatively be considered as its own corresponding part, as described above. The narrow waist may stabilize the implantation of the base portion near body tissue. This feature may also help to keep the arm portion in place before tightening the stretch line.
每个臂部可被提供有各自相应的线。例如，在软组织锚包括至少两个臂部的某些布置中，人造线可以是用于其中一个臂部的线，而对于其余的臂部，可以采用附加的线，每个附加的线均固定到人造线上(滑动接合或稳固接合)。另外，或替代地，两个臂部可以包括共同的线，该线连接到人造线/邻近基部的另一臂部的线。该线的第一端可连接到第一臂部的端盖，该线的第二端可连接到第二臂部的端盖。然后，该线的中央部分可以固定到人造线/任何其他线。Each arm may be provided with a respective wire. For example, in certain arrangements where the soft tissue anchor comprises at least two arms, the artificial wire may be the wire for one of the arms, and for the remaining arms, additional wires may be employed, each of which is secured to the artificial wire (either in a sliding engagement or in a secure engagement). Additionally, or alternatively, the two arms may comprise a common wire that is connected to the artificial wire/wire of the other arm adjacent the base. The first end of the wire may be connected to the end cap of the first arm, and the second end of the wire may be connected to the end cap of the second arm. The central portion of the wire may then be secured to the artificial wire/any other wire.
在线被穿线通过臂部的情况下，对于每个臂部，可以提供：基部中的孔；窄腰部中的孔；以及臂部中的至少一个孔。窄腰部中的孔可以定位的更靠近基部而不是相应的臂部(即，孔可以位于基部附近)。这种布置可以改善织物体周围的身体软组织的压缩，因为在靠近基部的窄腰部中布置的孔促使了基部朝向身体软组织/朝向塌缩的臂部的塌缩。因此，可以改善植入后锚固系统的稳定性。In the case where the wire is threaded through the arm, for each arm, there may be provided: a hole in the base; a hole in the narrow waist; and at least one hole in the arm. The hole in the narrow waist may be positioned closer to the base than the corresponding arm (i.e., the hole may be located near the base). This arrangement may improve the compression of the body soft tissue surrounding the fabric body, because the holes arranged in the narrow waist near the base promote the collapse of the base towards the body soft tissue/towards the collapsed arm. Therefore, the stability of the anchoring system after implantation may be improved.
在不设置窄腰部的情况下，针对每个臂部，可以设置：基部中的孔；以及臂部中的至少两个孔。In the absence of a narrow waist, for each arm portion there may be provided: a hole in the base; and at least two holes in the arm portion.
结合有形状保持构件的基部可帮助将软组织锚固系统放置在瓣叶的更宽区域(窄而深)的位置中，同时仍实现瓣叶支撑。The base incorporating the shape retaining member may help position the soft tissue anchoring system in a wider area of the leaflets (narrow and deep) while still achieving leaflet support.
拉伸线可以包括多条系绳线，每条系绳线与相应的臂部相关联(即，穿线通过基部和臂部)。The tension line may include a plurality of tether lines, each tether line being associated with a respective arm portion (ie, threaded through the base portion and the arm portion).
每条系绳线优选地连接到公共系绳点，其中，系绳点配置为当拉力施加到系绳点上时使每条系绳线处于拉力作用下。也就是说，系绳点配置为当系绳点本身处于拉力作用下时将拉力施加到每条系绳线上。Each tether line is preferably connected to a common tether point, wherein the tether point is configured to place each tether line under tension when tension is applied to the tether point. That is, the tether point is configured to apply tension to each tether line when the tether point itself is under tension.
通过提供包括多条系绳线的装置，每条系绳线由于共同的系绳点而处于拉力之下，软组织锚的臂部(和/或端盖，如果存在)可以各自受到拉力，该拉力沿着施加到系绳点的拉力的方向将它们拉向与系绳点相交的平面或轴线。这可以使得每个臂部被朝向彼此推动，进而在植入时捕获、聚集和/或夹紧位于臂部之间的任何多余身体组织。因此，这种装置可以恢复身体软组织的形状和/或为身体组织提供额外的结构支撑。By providing a device including multiple tether lines, each tether line being under tension due to a common tether point, the arms (and/or end caps, if present) of the soft tissue anchor can each be subjected to tension that pulls them toward a plane or axis that intersects the tether point in the direction of the tension applied to the tether point. This can cause each arm to be urged toward each other, thereby capturing, gathering and/or clamping any excess body tissue located between the arms when implanted. Thus, such a device can restore the shape of soft body tissue and/or provide additional structural support to body tissue.
当身体软组织是心脏瓣膜瓣叶时，包括多条分别连接到公共系绳点的系绳线的布置可能特别有利。如上所述，由于捕获多余的瓣叶组织而导致的瓣叶组织重塑形已被发现提供与瓣叶切除相似的结果。切除是现有心脏瓣膜修复方法中的常见手术步骤，其中，外科医生切除心脏瓣膜的受损部分并将剩余组织的边缘缝合在一起。切除通常在存在过多瓣叶组织的情况下进行。然而，通过提供包括系绳点和多条系绳线的线布置，可以避免切除步骤的需要。这可以简化整个手术过程。When the soft body tissue is a heart valve leaflet, an arrangement comprising multiple tether lines each connected to a common tether point may be particularly advantageous. As described above, reshaping of the leaflet tissue due to capture of excess leaflet tissue has been found to provide similar results to leaflet resection. Resection is a common surgical step in existing heart valve repair methods, in which the surgeon resects the damaged portion of the heart valve and sutures the edges of the remaining tissue together. Resection is typically performed in the presence of excess leaflet tissue. However, by providing a line arrangement comprising a tether point and multiple tether lines, the need for a resection step can be avoided. This can simplify the entire surgical procedure.
在所描述的实施例中，该线可被认为是一种系绳装置，其中，系绳装置包括多条系绳线。每条系绳线将穿线通过每个臂部和基部(并且每条系绳线的一端可固定到相应的端盖)，其中，每条系绳线配置为当拉力通过系绳点施加到系绳线上时，将每个臂部折叠成朝向基部塌缩。每条系绳线将在基部的与臂部相对侧上的位置处连接到系绳点。In the described embodiments, the line can be considered a tethering device, wherein the tethering device includes a plurality of tether lines. Each tether line will be threaded through each arm and the base (and one end of each tether line can be fixed to a corresponding end cap), wherein each tether line is configured to fold each arm to collapse toward the base when tension is applied to the tether line through the tether point. Each tether line will be connected to the tether point at a location on the opposite side of the base from the arm.
系绳点可以是固定的系绳点，使得系绳线在连接处不能相对于系绳点移动。系绳点可以是固定的结、眼板或其他合适的紧固件。The tether point may be a fixed tether point such that the tether line cannot move relative to the tether point at the point of connection. The tether point may be a fixed knot, eye plate or other suitable fastener.
或者，系绳点可以是可滑动的系绳点，使得系绳线能够相对于连接处的系绳点移动。系绳线可以以上述方式自行调节。系绳点可以是系绳结，通过一条共同的线提供多条系绳线。Alternatively, the tether point may be a slidable tether point, so that the tether line can move relative to the tether point at the connection. The tether line may be self-adjusting in the manner described above. The tether point may be a tether knot, providing multiple tether lines through a common line.
人造线可以连接到系绳点，并且可以配置为对系绳点施加拉力，即使系绳点处于拉力之下。The artificial line may be connected to the tether point and may be configured to apply tension to the tether point, even if the tether point is under tension.
人造线可以构成其中一条系绳线。其余系绳线可以在沿着人造线定位的系绳点处与人造线连接。The artificial line may constitute one of the tether lines. The remaining tether lines may be connected to the artificial line at tether points located along the artificial line.
优选地，所述系绳点被布置成在系绳点的第一侧上提供多个系绳线中的每一条，而单个拉力和/或人造线位于系绳点的与第一侧相对的第二侧上。这样的配置可以提供从系绳点到每条系绳线的更稳定的拉力分布。Preferably, the tether point is arranged to provide each of the plurality of tether lines on a first side of the tether point, while a single tension and/or artificial line is located on a second side of the tether point opposite the first side. Such a configuration may provide a more stable tension distribution from the tether point to each tether line.
多条系绳线可以由两条系绳线组成，在这种情况下，系绳装置可以包括Y形构型。多条系绳线可以由三条系绳线组成，在这种情况下，系绳装置可以包括三叉形构型。The plurality of tether lines may consist of two tether lines, in which case the tether arrangement may include a Y-shaped configuration. The plurality of tether lines may consist of three tether lines, in which case the tether arrangement may include a trident-shaped configuration.
在第二方面的软组织锚固系统的变型中，软组织锚固系统可以仅包括一个臂部，而不是至少两个臂部。可以理解的是，即使仅具有一个臂部，并使用其他特征(例如端盖)，也可以实现某些益处，如上所述。In a variation of the soft tissue anchoring system of the second aspect, the soft tissue anchoring system may include only one arm, rather than at least two arms. It is understood that certain benefits may be achieved even with only one arm and using other features (eg, end caps), as described above.
因此，从另一方面来看，提供了一种用于植入身体软组织中以保持线的软组织锚固系统，所述锚固系统包括：织物体，所述织物体包括基部和从所述基部延伸的至少一个臂部；其中，每个臂部构造成朝向所述基部折叠而塌缩，使得在使用中身体组织被夹在基部和每个臂部之间；其中，每个臂部包括端盖，所述端盖固定在每个臂部的远离基部的一端，其中，每个端盖构造成接收用于将锚植入身体组织中并在植入期间将臂部拉过身体组织的丝线引导构件。Therefore, from another aspect, there is provided a soft tissue anchoring system for implanting into body soft tissue to hold a wire, the anchoring system comprising: a fabric body comprising a base and at least one arm extending from the base; wherein each arm is configured to fold and collapse toward the base so that in use the body tissue is clamped between the base and each arm; wherein each arm comprises an end cap fixed at an end of each arm away from the base, wherein each end cap is configured to receive a wire guide member for implanting the anchor into body tissue and pulling the arm through the body tissue during implantation.
上述任一方面的软组织锚固系统可以是瓣膜锚固系统，用于植入心脏瓣膜瓣叶中，以固定人造腱索线。心脏瓣膜瓣叶可以是二尖瓣瓣叶或三尖瓣瓣叶。The soft tissue anchoring system of any aspect above can be a valve anchoring system, which is used for implantation in a heart valve leaflet to fix an artificial tendon cord. The heart valve leaflet can be a mitral valve leaflet or a tricuspid valve leaflet.
从本发明的第三方面来看，提供了一种用于植入身体软组织中以固定人造线的软组织锚固系统，所述锚固系统包括：多个锚固构件；以及包括多条系绳线和公共系绳点的系绳装置；其中，每条系绳线与相应的锚固构件相关联并且连接到公共系绳点；其中，系绳点被配置为当软组织锚固系统植入身体软组织中并且系绳点本身处于拉力下时使每条系绳线处于拉力下，使得每个锚固构件被朝向与系绳点相交的轴线和向系绳点施加拉力的方向推动。From the third aspect of the present invention, there is provided a soft tissue anchoring system for implanting in the soft tissue of the body to fix an artificial thread, the anchoring system comprising: a plurality of anchoring members; and a tethering device comprising a plurality of tether lines and a common tethering point; wherein each tether line is associated with a corresponding anchoring member and connected to the common tethering point; wherein the tethering point is configured to put each tether line under tension when the soft tissue anchoring system is implanted in the soft tissue of the body and the tethering point itself is under tension, so that each anchoring member is pushed toward an axis intersecting the tethering point and in a direction in which tension is applied to the tethering point.
通过提供包含多条系绳线的系绳装置，每条系绳线由于共同的系绳点而处于拉力之下，软组织锚固系统的锚固构件可以各自受到拉力，该拉力将它们沿着施加到系绳点的拉力的方向拉向与系绳点相交的平面或轴线。这可以导致每个锚固构件被推向彼此，进而在植入时捕获、聚集和/或夹紧位于锚固构件之间的任何多余身体组织。因此，这种布置可以恢复身体软组织的形状和/或为身体组织提供额外的结构支撑。By providing a tether arrangement comprising a plurality of tether lines, each tether line being under tension due to a common tether point, the anchor members of the soft tissue anchoring system can be individually subjected to tension that pulls them in the direction of the tension applied to the tether point toward a plane or axis intersecting the tether point. This can result in each anchor member being urged toward each other, thereby capturing, gathering and/or clamping any excess body tissue located between the anchor members when implanted. Thus, this arrangement can restore the shape of body soft tissue and/or provide additional structural support to body tissue.
当身体软组织是心脏瓣膜瓣叶时，包括多条分别连接到公共系绳点的系绳装置可能特别有利。如上所述，通过捕获多余的瓣叶组织而导致的瓣叶组织重塑已被发现提供与瓣叶切除相似的结果。切除是现有心脏瓣膜修复方法中的常见手术步骤，其中，外科医生切除心脏瓣膜的受损部分并将剩余组织的边缘缝合在一起。切除通常在存在过多瓣叶组织的情况下进行。然而，通过提供包括系绳点和多条系绳线的线装置，可以避免切除步骤。这可以简化整个手术程序。When the soft body tissue is a heart valve leaflet, a tether device comprising multiple tether lines each connected to a common tether point may be particularly advantageous. As described above, leaflet tissue remodeling caused by capturing excess leaflet tissue has been found to provide similar results to leaflet resection. Resection is a common surgical step in existing heart valve repair methods, in which the surgeon resects the damaged portion of the heart valve and sutures the edges of the remaining tissue together. Resection is typically performed in the presence of excess leaflet tissue. However, by providing a line device comprising a tether point and multiple tether lines, the resection step can be avoided. This can simplify the entire surgical procedure.
软组织锚固系统可以是瓣叶锚固系统。身体软组织可以是瓣叶心脏瓣膜。人造线可以是人造腱索线。The soft tissue anchoring system may be a leaflet anchoring system. The body soft tissue may be a leaflet heart valve. The artificial line may be an artificial chord line.
每个锚固构件可被配置为穿过身体软组织，其中，系绳线穿过身体软组织。因此，系绳点可配置为当每条系绳线以远离身体组织表面的方向穿过组织时以及当系绳点本身处于拉力下时，使每条系绳线处于拉力下。Each anchoring member can be configured to pass through soft body tissue, wherein the tether line passes through the soft body tissue. Thus, the tether point can be configured to place each tether line under tension when it passes through the tissue in a direction away from the surface of the body tissue and when the tether point itself is under tension.
系绳点可以是固定系绳点，使得系绳线在连接处不能相对于系绳点移动。系绳点可以是固定结、眼板或其他合适的紧固件。The tether point may be a fixed tether point such that the tether line cannot move relative to the tether point at the point of connection. The tether point may be a fixed knot, eye plate or other suitable fastener.
或者，系绳点可以是可滑动的系绳点，使得系绳线就可以在连接处相对于系绳点移动。系绳线可以以上述方式自行调节。系绳点可以是系绳结，通过一条共同的线提供多条系绳线。Alternatively, the tether point may be a slidable tether point so that the tether line can move relative to the tether point at the connection. The tether line can be self-adjusting in the manner described above. The tether point may be a tether knot, providing multiple tether lines through a common line.
人造线可以连接到系绳点，并且可以配置为对系绳点施加拉力，即使系绳点处于拉力之下。The artificial line may be connected to the tether point and may be configured to apply tension to the tether point, even if the tether point is under tension.
人造线可以构成其中一条系绳线。其余系绳线可以在沿着人造线定位的系绳点处与人造线连接。The artificial line may constitute one of the tether lines. The remaining tether lines may be connected to the artificial line at tether points located along the artificial line.
优选地，所述系绳点被布置成在系绳点的第一侧上提供多个系绳线中的每一条，而单个拉力和/或人造线位于系绳点的与第一侧相对的第二侧上。这样的配置可以提供从系绳点到每条系绳线的更稳定的拉力分布。Preferably, the tether point is arranged to provide each of the plurality of tether lines on a first side of the tether point, while a single tension and/or artificial line is located on a second side of the tether point opposite the first side. Such a configuration may provide a more stable tension distribution from the tether point to each tether line.
所述多条系绳线可以由两条系绳线组成，在这种情况下，系绳装置可以包括Y形构型。所述多条系绳线可以由三条系绳线组成，在这种情况下，系绳装置可以包括三叉形构型。The plurality of tether lines may consist of two tether lines, in which case the tether device may comprise a Y-shaped configuration. The plurality of tether lines may consist of three tether lines, in which case the tether device may comprise a trident-shaped configuration.
每个锚固构件可以是管状盖构件。管状盖构件可以是如上所述的形式，例如根据第一方面所述的形式。Each anchoring member may be a tubular cover member. The tubular cover member may be of the form described above, for example according to the first aspect.
每个锚固构件可以是臂部和/或端盖。臂部和/或端盖可以是如上所述的形式，例如根据第二方面所述的形式。Each anchoring member may be an arm and/or an end cap. The arm and/or the end cap may be of the form described above, for example according to the second aspect.
所述多个锚固构件可以包括管状盖构件和臂部和/或端盖。The plurality of anchoring members may include a tubular cover member and arms and/or end caps.
虽然上述方面所讨论的软组织锚固系统在心脏的治疗中可能具有特定优势和应用，但除非另有说明，否则它们的应用不应被认为局限于心脏软组织的治疗。Although the soft tissue anchoring systems discussed in the above aspects may have particular advantages and applications in the treatment of the heart, their use should not be considered limited to the treatment of cardiac soft tissue unless otherwise specified.
软组织锚固系统可以通过合适的部署装置(有利地为导管装置)部署。部署装置可以包括锚部署机构，其在部署期间(例如在刺穿身体组织和植入织物体的臂部期间)保持和/或引导软组织锚固系统。锚部署机构或保持锚部署机构的导管装置的另一部分还可用于移除丝线引导构件和/或拉伸拉伸线，以便将臂部和端盖放置到其最终位置，例如，将臂部折叠并将端盖转动以沿着身体组织的表面放置。The soft tissue anchoring system can be deployed by a suitable deployment device (advantageously a catheter device). The deployment device may include an anchor deployment mechanism that holds and/or guides the soft tissue anchoring system during deployment (e.g., during piercing body tissue and implanting the arm of the fabric body). The anchor deployment mechanism or another portion of the catheter device that holds the anchor deployment mechanism can also be used to remove the wire guide member and/or stretch the stretch wire so that the arm and end cap are placed in their final position, for example, folding the arm and rotating the end cap to place along the surface of the body tissue.
因此，从本发明的第四方面来看，提供了一种用于在心脏组织中植入软组织锚固系统的导管装置，该导管装置包括：壳体部分，其中，壳体部分从导管装置的远端沿着导管装置的长度向导管装置的近端延伸；以及位于壳体部分内的如前述任一方面所述的软组织锚。Therefore, from the fourth aspect of the present invention, a catheter device for implanting a soft tissue anchoring system in cardiac tissue is provided, the catheter device comprising: a shell portion, wherein the shell portion extends from the distal end of the catheter device along the length of the catheter device to the proximal end of the catheter device; and a soft tissue anchor as described in any of the preceding aspects located within the shell portion.
第四方面的导管装置可具有与本发明前述方面的软组织锚固系统的特征相对应的一个或更多个特征。因此，前述方面的软组织锚固系统的上述描述，包括但不限于所有技术优点和替代实施例，可同样适用于第四方面的导管装置。The catheter device of the fourth aspect may have one or more features corresponding to the features of the soft tissue anchoring system of the previous aspect of the present invention. Therefore, the above description of the soft tissue anchoring system of the previous aspect, including but not limited to all technical advantages and alternative embodiments, may also apply to the catheter device of the fourth aspect.
导管装置可包括用于从壳体部分部署软组织锚固系统的丝线引导构件。当软组织锚固系统包括端盖时，导管装置可包括与开口接合的丝线引导构件。The catheter device may include a wire guiding member for deploying the soft tissue anchor system from the housing portion.When the soft tissue anchor system includes an end cap, the catheter device may include a wire guiding member engaged with the opening.
丝线引导构件可包括肩部。壳体部分可包括止动部分，该止动部分构造成与肩部配合，从而限制丝线引导构件在壳体部分中的远端平移。The wire guiding member may comprise a shoulder.The housing portion may comprise a stop portion configured to cooperate with the shoulder so as to limit distal translation of the wire guiding member in the housing portion.
通过限制丝线引导构件的远端平移，可以防止在软组织锚固系统植入期间发生丝线引导构件的过度延伸。例如，当导管装置在递送到植入部位期间经历弯曲时，丝线引导构件的路径可以相对于导管装置的纵向轴线缩短或延长。因此，通过限制丝线引导构件在壳体部分中的远端平移，可以更好地控制丝线引导构件的最终部署长度。这可能特别有利于确保在使用多个丝线引导构件的情况下，丝线引导构件延伸到相同的最终长度，以促进端盖和/或臂部在身体组织中的稳定和对称植入。By limiting the distal translation of the wire guide member, it is possible to prevent the overextension of the wire guide member during the implantation of the soft tissue anchoring system. For example, when the catheter device undergoes bending during delivery to the implantation site, the path of the wire guide member can be shortened or extended relative to the longitudinal axis of the catheter device. Therefore, by limiting the distal translation of the wire guide member in the housing portion, the final deployment length of the wire guide member can be better controlled. This may be particularly helpful to ensure that when using multiple wire guide members, the wire guide member extends to the same final length to promote the stable and symmetrical implantation of the end cap and/or arm in the body tissue.
因此，丝线引导构件可以包括用于限制丝线引导构件在壳体部分中的远端平移范围的肩部(即，第一肩部)，以及配置为与端盖配合/接合以将锚固系统植入身体组织中的对应部分/肩部区域(即，第二肩部)。Thus, the wire guide member may include a shoulder (i.e., a first shoulder) for limiting the distal translation range of the wire guide member in the shell portion, and a corresponding portion/shoulder area (i.e., a second shoulder) configured to cooperate/engage with the end cap to implant the anchoring system into body tissue.
从本发明的第五个方面来看，提供了一种用于在心脏组织中植入软组织锚固系统的导管装置，该导管装置包括：壳体部分，其中，该壳体部分从导管装置的远端沿着导管装置的长度向导管装置的近端延伸；软组织锚固系统，其包括多个锚固构件；以及From a fifth aspect of the present invention, there is provided a catheter device for implanting a soft tissue anchoring system in cardiac tissue, the catheter device comprising: a housing portion, wherein the housing portion extends from a distal end of the catheter device along a length of the catheter device toward a proximal end of the catheter device; a soft tissue anchoring system comprising a plurality of anchoring members; and
部署系统，其被配置为同时将每个锚固构件植入心脏组织中；其中，部署系统包括多个丝线引导构件，其中，每个丝线引导构件包括位于丝线引导构件远端处的导引部分，并且其被配置为接合相应的锚固构件；并且其中，部署系统被配置为在植入锚固构件期间保持多个丝线引导构件的导引部分之间的共面对准。A deployment system configured to simultaneously implant each anchoring member into cardiac tissue; wherein the deployment system includes a plurality of wire guide members, wherein each wire guide member includes a guide portion located at a distal end of the wire guide member and configured to engage a corresponding anchoring member; and wherein the deployment system is configured to maintain coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the anchoring members.
发明人认识到，当在心脏组织中植入包含多个锚固构件的软组织锚固系统时，期望的是将每个锚固构件同时植入心脏组织中。同时植入锚固构件可以提高植入的系统的稳定性，因为锚固构件可以以相同且更好控制的方式部署。此外，同时植入锚固构件可以降低植入过程的复杂性。The inventors have recognized that when implanting a soft tissue anchoring system comprising multiple anchoring members in cardiac tissue, it is desirable to implant each anchoring member into the cardiac tissue simultaneously. Simultaneous implantation of the anchoring members can improve the stability of the implanted system because the anchoring members can be deployed in the same and better controlled manner. In addition, simultaneous implantation of the anchoring members can reduce the complexity of the implantation process.
然而，发明人还认识到，在通过导管装置将软组织锚固系统递送到心脏的过程中，导管装置的递送轴可能会因导管装置所通行穿过的血管的曲度而发生弯曲。这种弯曲可能导致导管装置的各个部件不得不根据它们在递送到心脏过程中经历的曲率半径而穿行通过不同的距离。这可能会给用于将软组织锚固系统的锚固构件植入心脏组织的丝线引导构件带来问题。如果一个丝线引导构件比另一个丝线引导构件穿行的距离大，则各自由相应的丝线引导构件部署的锚固构件可能无法同时植入心脏组织中，因为丝线引导构件在被递送到心脏的过程中可能会变得不对称地拉伸或定位。这可能会影响部署系统同时将锚固构件植入心脏组织的能力。However, the inventors also recognize that in the process of delivering the soft tissue anchoring system to the heart by the catheter device, the delivery axis of the catheter device may be bent due to the curvature of the blood vessel through which the catheter device passes. This bending may cause the various components of the catheter device to have to travel through different distances according to the radius of curvature they experience during delivery to the heart. This may cause problems for the wire guide member used to implant the anchoring member of the soft tissue anchoring system into the heart tissue. If the distance traveled by one wire guide member is larger than that of another wire guide member, the anchoring members deployed by the corresponding wire guide member may not be implanted in the heart tissue at the same time, because the wire guide member may become asymmetrically stretched or positioned during delivery to the heart. This may affect the ability of the deployment system to implant the anchoring member into the heart tissue at the same time.
因此，部署系统被配置成在植入锚固构件期间保持所述多个丝线引导构件的导引部分之间的共面对准。这样，无论丝线引导构件在递送期间各自独立经历的曲率如何，最终在植入期间操纵锚固构件的丝线引导构件的端部将保持对准，使得锚固构件将同时植入。通过控制丝线引导构件的导引部分的共面对准，在丝线引导构件与相应的锚固构件接合之前，可以恢复由于曲率不同而导致的丝线引导构件的任何可能的偏转。Therefore, the deployment system is configured to maintain coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the anchoring member. In this way, regardless of the curvature that the wire guide members experience independently during delivery, the ends of the wire guide members that manipulate the anchoring members during implantation will remain aligned so that the anchoring members will be implanted simultaneously. By controlling the coplanar alignment of the guide portions of the wire guide members, any possible deflection of the wire guide members caused by different curvatures can be restored before the wire guide members engage with the corresponding anchoring members.
应当理解，通过同时植入，锚固构件本身被同时植入心脏组织中，并且还在相同动作或运动期间被植入心脏组织中。It should be understood that by simultaneous implantation, the anchoring members themselves are implanted into the cardiac tissue simultaneously and also during the same action or movement.
当导引部分的等同点或等同部分(例如，丝线引导构件本身的端部)位于彼此基本相同的平面中时，导引部分将被理解为共面地对齐，所述平面被限定为垂直于导管装置或丝线引导构件本身的纵向轴线。当导引构件与同一平面重合时，或者当它们位于同一平面内且公差小于0.5毫米、小于1.0毫米或小于1.5毫米时，导引构件可被视为共面对齐。The guide portions will be understood to be coplanarly aligned when equivalent points or equivalent portions of the guide portions (e.g., the ends of the wire guide member itself) lie in substantially the same plane as one another, the plane being defined as being perpendicular to the longitudinal axis of the catheter device or the wire guide member itself. The guide members may be considered coplanarly aligned when they coincide with the same plane, or when they lie in the same plane with a tolerance of less than 0.5 mm, less than 1.0 mm, or less than 1.5 mm.
每个丝线引导构件包括近端和远端。位于远端的部分是导引部分，其被配置成接合相应的锚固构件，如上所述。每个丝线引导构件还可以包括控制部分，其从导引部分延伸并且位于近端处和/或靠近近端。Each wire guide member includes a proximal end and a distal end. The portion located at the distal end is a guide portion, which is configured to engage a corresponding anchoring member, as described above. Each wire guide member may also include a control portion, which extends from the guide portion and is located at and/or near the proximal end.
导引部分可包括尖头末端，其被配置为在植入期间刺穿心脏组织。或者，导引部分可配置为由锚固构件的开口接收，使得导引部分向锚固构件提供动力，锚固构件本身刺穿心脏组织。The guide portion may include a pointed tip configured to pierce cardiac tissue during implantation. Alternatively, the guide portion may be configured to be received by an opening of an anchoring member so that the guide portion provides power to the anchoring member, which itself pierces cardiac tissue.
控制部分可以比导引部分厚，即具有较大的直径。控制部分通常从导管装置的壳体延伸并穿过导管装置的递送轴。控制部分可以延伸到导管装置的递送手柄，递送手柄位于导管装置的近端。The control portion may be thicker than the guide portion, ie, have a larger diameter. The control portion typically extends from the housing of the catheter device and through the delivery shaft of the catheter device. The control portion may extend to a delivery handle of the catheter device, which is located at the proximal end of the catheter device.
导引部分的直径(即外径)可以为大约0.3毫米。控制部分的直径(即外径)可以为大约0.5毫米。The diameter (ie, outer diameter) of the guide portion may be approximately 0.3 mm. The diameter (ie, outer diameter) of the control portion may be approximately 0.5 mm.
每个丝线引导构件可以包括凸起部分。Each wire guiding member may comprise a raised portion.
凸起部分优选位于引导部分与控制部分之间，且其直径大于引导部分和控制部分的直径。The raised portion is preferably located between the guide portion and the control portion, and has a diameter greater than the diameters of the guide portion and the control portion.
凸起部分的直径(即外径)可以为大约0.8毫米。凸起部分的直径可以为0.6至0.9毫米之间。The diameter (ie, outer diameter) of the raised portion may be approximately 0.8 mm. The diameter of the raised portion may be between 0.6 and 0.9 mm.
凸起部分的长度可以约等于其直径。凸起部分的长度可以约为0.8毫米。The length of the raised portion may be approximately equal to its diameter. The length of the raised portion may be approximately 0.8 mm.
凸起部分具有球状形状。球状形状优选包括限定凸起部分的最大直径的中央部分，以及位于中央部分两侧的两个锥形/过渡部分。The raised portion has a spherical shape. The spherical shape preferably comprises a central portion defining the maximum diameter of the raised portion, and two tapered/transition portions located on either side of the central portion.
每个丝线引导构件可在第一构型和第二构型之间移动，其中，在第一构型中，凸起部分被配置为接合第一障碍物，该第一障碍物被配置为限制丝线引导构件在近端方向上的平移，并且在第二构型中，丝线引导构件被配置为接合相应的锚固构件。Each wire guide member is movable between a first configuration and a second configuration, wherein, in the first configuration, the raised portion is configured to engage a first obstacle configured to limit translation of the wire guide member in a proximal direction, and in the second configuration, the wire guide member is configured to engage a corresponding anchoring member.
通过限制丝线引导构件在近端方向的平移，防止了丝线引导构件在部署期间不对称地缩回导管装置的递送轴中(例如，由于递送期间的弯曲而经历的拉力延伸)。第一障碍物还提供了参考点，通过该参考点，可以恢复或维持在将导管装置递送到心脏期间，丝线引导构件的共面对准。例如，当凸起部分抵靠第一障碍物时，丝线引导构件的导引部分可以彼此共面对准。丝线引导构件的导引部分的共面对准可以通过自动或手动将每个丝线引导构件移动到第一构型来恢复。因此，可以理解，第一障碍物本身彼此共面对准。By limiting the translation of the wire guide member in the proximal direction, the wire guide member is prevented from asymmetrically retracting into the delivery shaft of the catheter device during deployment (for example, due to the extension of the tension experienced by the bending during delivery). The first obstacle also provides a reference point, by which the coplanar alignment of the wire guide member can be restored or maintained during the delivery of the catheter device to the heart. For example, when the protruding portion abuts against the first obstacle, the guiding portion of the wire guide member can be coplanarly aligned with each other. The coplanar alignment of the guiding portion of the wire guide member can be restored by automatically or manually moving each wire guide member to the first configuration. Therefore, it is understood that the first obstacle itself is coplanarly aligned with each other.
第一障碍物可以限定通道或凹槽，控制部分可以通过该通道或凹槽，但导引部分不能通过该通道或凹槽。The first obstacle may define a passage or a groove through which the control portion may pass but through which the guide portion may not pass.
第一障碍物可以是位于壳体部分的近端部分的抵接部分。The first obstacle may be an abutment portion located at a proximal portion of the housing portion.
通过将第一个障碍物放置在壳体的近端部分，可以维持或恢复共面对准的点位于在递送过程中可能经历弯曲的丝线引导构件的任何部分的远端。By placing the first obstruction at the proximal portion of the housing, the point at which coplanar alignment may be maintained or restored is distal to any portion of the wire guiding member that may experience bending during delivery.
所述多个丝线引导构件的导引部分被配置为当凸起部分抵靠第一障碍物时共面对齐。The guide portions of the plurality of wire guiding members are configured to be coplanarly aligned when the raised portions abut against the first obstacle.
抵接部分可以与凸起部分的形状互补，使得凸起部分被配置为在第一构型中与抵接部分匹配。The abutment portion may be complementary in shape to the raised portion such that the raised portion is configured to mate with the abutment portion in the first configuration.
在第二构型中，凸起部分可以配置为抵接锚固构件的互补部分。In the second configuration, the raised portion may be configured to abut a complementary portion of the anchor member.
互补部分可以是凸起部分的锥形/过渡部分。The complementary portion may be a tapered/transitional portion of the raised portion.
因此，凸起部分可以提供一表面或部分，通过该表面或部分，丝线引导构件可以向锚固构件提供动力。Thus, the raised portion may provide a surface or portion through which the wire guiding member may provide power to the anchoring member.
凸起部分本身可以充当肩部，其被构造成与管状盖构件或端盖的喇叭形入口接合，如分别在第一和第二方面以及任何相关方面中所述。The raised portion itself may act as a shoulder configured to engage with a flared inlet of a tubular cover member or end cap as described in the first and second aspects respectively and any related aspects.
替代地，在第二构型中，凸起部分可以被配置为邻接位于壳体部分的远端部分中的第二抵接部分，其中，第二抵接部分被配置为限制丝线引导构件在远端方向上的平移。Alternatively, in the second configuration, the raised portion may be configured to abut a second abutment portion located in a distal portion of the housing portion, wherein the second abutment portion is configured to limit translation of the wire guiding member in the distal direction.
在壳体部分的远端部分中设置第二抵接部分可以防止在软组织锚固系统植入过程中丝线引导构件的过度延伸。Providing a second abutment portion in the distal portion of the housing portion may prevent overextension of the wire guiding member during implantation of the soft tissue anchoring system.
第二抵接部分可以包括通道或凹槽，控制部分和导引部分可以通过该通道或凹槽，但凸起部分不能通过该通道或凹槽。The second abutment portion may include a channel or a groove through which the control portion and the guide portion may pass, but through which the protruding portion may not pass.
在这种布置中，凸起部分可以位于控制部分内，而不是位于控制部分和导引部分之间。In this arrangement, the raised portion may be located within the control portion rather than between the control portion and the guide portion.
丝线引导构件可以包括延伸在控制部分和导引部分之间的肩部。肩部可在控制部分和导引部分之间形成倾斜过渡。肩部可构造成抵靠或接合锚固构件的互补部分，从而在植入期间向锚固构件提供动力。The wire guide member may include a shoulder extending between the control portion and the guide portion. The shoulder may form an inclined transition between the control portion and the guide portion. The shoulder may be configured to abut or engage a complementary portion of the anchoring member, thereby providing power to the anchoring member during implantation.
部署系统可以配置为通过手动将导引部分恢复到共同平面来被动地保持导引部分之间的共面对齐。例如，用户可以在将导管装置递送到心脏组织时拉动每个丝线引导构件，其中，每个第一障碍物提供用于恢复共面对齐的表面。The deployment system can be configured to passively maintain coplanar alignment between the guide portions by manually restoring the guide portions to a common plane. For example, a user can pull each wire guide member when delivering the catheter device to cardiac tissue, wherein each first obstacle provides a surface for restoring coplanar alignment.
或者，部署系统可以被配置为通过自动将导引部分恢复到公共平面来主动维持导引部分之间的共面对准。Alternatively, the deployment system may be configured to actively maintain coplanar alignment between the guide portions by automatically restoring the guide portions to a common plane.
部署系统可以包括弹簧装置。每个丝线引导构件可以连接到弹簧装置。弹簧装置可以配置为在将导管装置递送到心脏期间自动恢复多个丝线引导构件的导引部分之间的共面对准。弹簧装置可以是配置为主动保持导引部分之间的共面对准的装置的一个示例。The deployment system may include a spring device. Each wire guide member may be connected to the spring device. The spring device may be configured to automatically restore the coplanar alignment between the guide portions of the plurality of wire guide members during delivery of the catheter device to the heart. The spring device may be an example of a device configured to actively maintain the coplanar alignment between the guide portions.
弹簧装置可以向所述多个丝线引导构件提供一个或更多个控制输入。The spring arrangement may provide one or more control inputs to the plurality of wire guiding members.
优选地，弹簧装置被配置成将每个丝线引导构件偏压至第一构型。Preferably, the spring arrangement is configured to bias each wire guiding member to the first configuration.
通过提供配置为将每个丝线引导构件偏向第一构型的弹簧装置，部署系统可以在将导管装置递送到心脏期间自动恢复丝线引导构件的导引部分之间的共面对准。By providing a spring device configured to bias each wire guiding member toward the first configuration, the deployment system can automatically restore co-planar alignment between the guiding portions of the wire guiding members during delivery of the catheter device to the heart.
弹簧装置可包括多个弹簧构件，每个弹簧构件选择性地连接至相应的丝线引导构件。每个弹簧构件可配置为向相应的丝线引导构件提供恢复力。The spring arrangement may comprise a plurality of spring members, each spring member being selectively connected to a respective wire guiding member.Each spring member may be configured to provide a restoring force to a respective wire guiding member.
弹簧装置可配置为调节各个丝线引导构件之间的相对拉力。调节各个丝线引导构件之间的相对拉力可以保持导引部分的共面对齐，而不管控制部分在导管装置递送期间发生任何偏转或错位或其他情况。The spring device may be configured to adjust the relative tension between the wire guide members. Adjusting the relative tension between the wire guide members may maintain coplanar alignment of the guide portions regardless of any deflection or misalignment of the control portion or other conditions during delivery of the catheter device.
弹簧装置可包括：拉伸调节机构，用于放松每个丝线引导构件中的拉伸；以及拉伸恢复器，用于放松或平衡各个丝线引导构件之间的相对拉伸。拉伸调节机构可放松任何丝线引导构件因偏转或弯曲而受到拉伸时所经受的拉力，这种拉伸可能由于第一障碍物阻止丝线引导构件缩回递送轴而体现为拉拽力。拉伸恢复器可通过调节每个丝线引导构件上的横向力(即，沿垂直于弹簧装置中的丝线的纵向延伸的方向施加的力)来缓解拉伸。因此，拉伸恢复器可通过弓形拉伸原理(principle of bow tens ion)缓解任何拉伸，其中，丝线的横向位移的变化会增加或减少丝线引导构件中的纵向拉伸。The spring device may include: a tension adjustment mechanism for relaxing the tension in each wire guide member; and a tension restorer for relaxing or balancing the relative tension between the wire guide members. The tension adjustment mechanism can relax the tension experienced by any wire guide member when it is stretched due to deflection or bending, and this stretch may be manifested as a pulling force due to the first obstacle preventing the wire guide member from retracting the delivery axis. The tension restorer can relieve the stretch by adjusting the lateral force on each wire guide member (i.e., the force applied in a direction perpendicular to the longitudinal extension of the wire in the spring device). Therefore, the tension restorer can relieve any stretch by the principle of bow tension, wherein the change in the lateral displacement of the wire can increase or decrease the longitudinal stretch in the wire guide member.
弹簧装置可位于导管装置的递送手柄中。The spring device may be located in a delivery handle of the catheter device.
所述多个丝线引导构件可配置为通过单个控制输入同时平移。单个控制输入可配置为选择性地接合所述多个丝线引导构件。一旦在导管装置的递送期间恢复丝线引导构件的共面对准(或假设保持丝线引导构件的共面对准)，相等和/或对称的纵向平移将对丝线引导构件进行相等且因此同时的操作，以同时植入锚固构件。The multiple wire guide members can be configured to translate simultaneously by a single control input. The single control input can be configured to selectively engage the multiple wire guide members. Once the coplanar alignment of the wire guide members is restored during the delivery of the catheter device (or the coplanar alignment of the wire guide members is assumed to be maintained), equal and/or symmetrical longitudinal translations will operate the wire guide members equally and therefore simultaneously to simultaneously implant the anchoring member.
单个控制输入可以包括配置为传送平移输入的第一组齿轮和配置为平移每个丝线引导构件的第二组齿轮。第一组齿轮与第二组齿轮互补，并且可选择性地接合。在导管装置被递送到心脏组织后，在植入之前，这些齿轮优选彼此接合。第一组齿轮可同时操作，使得各个丝线引导构件通过所述单个控制输入同时地平移。The single control input may include a first set of gears configured to transmit a translation input and a second set of gears configured to translate each wire guide member. The first set of gears is complementary to the second set of gears and can be selectively engaged. After the catheter device is delivered to the cardiac tissue, before implantation, the gears are preferably engaged with each other. The first set of gears can be operated simultaneously so that each wire guide member is translated simultaneously by the single control input.
弹簧装置可被配置为在控制和/或接合所述单个控制输入之前选择性地与所述多个丝线引导构件断开。弹簧装置可配置为选择性地重新连接，例如在导管装置缩回之前。The spring arrangement may be configured to selectively disconnect from the plurality of wire guiding members prior to controlling and/or engaging the single control input.The spring arrangement may be configured to selectively reconnect, for example prior to retraction of the catheter arrangement.
弹簧装置可以作为所述单个控制输入的一部分提供。Spring means may be provided as part of said single control input.
每个锚固构件可以是软组织锚固系统的管状盖构件。Each anchor member may be a tubular cover member of the soft tissue anchor system.
软组织锚固系统可以是根据第一方面的软组织锚固系统。因此，第五方面的导管装置可以具有与第一方面和本发明的其他相关方面的软组织锚固系统的特征相对应的一个或更多个特征。The soft tissue anchoring system may be the soft tissue anchoring system according to the first aspect.Thus, the catheter device of the fifth aspect may have one or more features corresponding to the features of the soft tissue anchoring system of the first aspect and other related aspects of the invention.
每个锚固构件可以是软组织锚固系统的端盖。Each anchoring member may be an end cap of a soft tissue anchoring system.
软组织锚固系统可以是根据第二方面的软组织锚固系统。因此，第五方面的导管装置可以具有与第二方面和本发明的其他相关方面的软组织锚固系统的特征相对应的一个或更多个特征。The soft tissue anchoring system may be the soft tissue anchoring system according to the second aspect.Thus, the catheter device of the fifth aspect may have one or more features corresponding to the features of the soft tissue anchoring system of the second aspect and other related aspects of the invention.
软组织锚固系统可以是根据第三方面的软组织锚固系统。因此，第五方面的导管装置可以具有与第三方面和本发明的其他相关方面的软组织锚固系统的特征相对应的一个或更多个特征。The soft tissue anchoring system may be the soft tissue anchoring system according to the third aspect.Thus, the catheter device of the fifth aspect may have one or more features corresponding to the features of the soft tissue anchoring system of the third aspect and other related aspects of the invention.
因此，前述方面的软组织锚固系统的上述描述，包括但不限于所有技术优点和替代实施例，可同样适用于第五方面的导管装置。Therefore, the above description of the soft tissue anchoring system of the previous aspect, including but not limited to all technical advantages and alternative embodiments, may also apply to the catheter device of the fifth aspect.
以下特征可以是本发明第四方面和/或第五方面的导管装置的特征。The following features may feature the catheter device of the fourth and/or fifth aspects of the invention.
导管装置可以包括锚部署机构，其在部署期间(例如在刺穿身体组织和植入织物体的臂部期间)保持和/或引导软组织锚固系统。锚部署机构或保持锚部署机构的导管装置的另一部分还可用于移除丝线引导构件和/或拉伸拉伸线，以便将臂部和/或端盖放置到其最终位置，例如使得臂部被折叠和/或端盖被转动以沿着身体组织的表面放置。The catheter device may include an anchor deployment mechanism that holds and/or guides the soft tissue anchoring system during deployment (e.g., during penetration of body tissue and implantation of the arm of the fabric body). The anchor deployment mechanism or another portion of the catheter device that holds the anchor deployment mechanism may also be used to remove the wire guide member and/or stretch the stretch wire so as to place the arm and/or end cap into its final position, such as so that the arm is folded and/or the end cap is rotated to be placed along the surface of body tissue.
软组织锚固系统可以被保持在导管装置中的帘或护套内。护套可配置为在部署期间偏转或皱缩，以帮助从导管装置部署软组织锚固系统。护套可在从导管装置部署软组织锚固系统期间减少软组织锚固系统和导管装置之间的摩擦。The soft tissue anchor system can be retained within a curtain or sheath in the catheter device. The sheath can be configured to deflect or collapse during deployment to assist in deploying the soft tissue anchor system from the catheter device. The sheath can reduce friction between the soft tissue anchor system and the catheter device during deployment of the soft tissue anchor system from the catheter device.
该护套可以是薄管状护套。The sheath may be a thin tubular sheath.
当软组织锚固系统包括织物体时，护套可用于保持织物体。当软组织锚固系统包括管状盖构件/端盖时，所述构件/盖可被保持在护套外部或内部。When the soft tissue anchoring system comprises a fabric body, a sheath may be used to retain the fabric body.When the soft tissue anchoring system comprises a tubular cover member/end cap, the member/cap may be retained outside or inside the sheath.
该护套可以容纳在锚部署机构内。The sheath may be housed within the anchor deployment mechanism.
护套可以附接或固定到锚部署机构，使得其在从导管装置部署软组织锚固系统期间不会从导管装置释放。The sheath may be attached or secured to the anchor deployment mechanism so that it is not released from the catheter device during deployment of the soft tissue anchor system from the catheter device.
锚部署机构可以包括锚部署管，该锚部署管用于保持和引导软组织锚固系统的各部分(例如臂部和/或端盖)，以及丝线引导构件。The anchor deployment mechanism may include an anchor deployment tube for holding and guiding portions of the soft tissue anchor system (eg, arms and/or end caps), and a wire guiding member.
在使用多个臂部的情况下，例如使用U形织物体和两个臂部，则锚部署管可以包括一对管，每个用于每个臂部及其各自的丝线引导构件，管之间有连接，从而允许臂部之间的基部织物连接桥部跨在管之间。例如，沿着管可以具有狭槽，用于连接桥部沿其滑动。Where multiple arms are used, such as a U-shaped fabric body and two arms, the anchor deployment tube may include a pair of tubes, one for each arm and its respective wire guide member, with connections between the tubes to allow a base fabric bridge between the arms to span between the tubes. For example, there may be slots along the tubes for the bridge to slide along.
类似地，在使用包括两个管状盖构件/T形杆锚的软组织锚固系统的情况下，每个管状盖构件/T形杆锚通过共同的线连接(例如，在两个管状盖构件的相应中央部分之间延伸的单条线，其连接到该线的中央部分处的人造线；或者两条线，例如，每条线连接到相应的管状盖构件的中央部分并且在其端部的远端处彼此固定)，则锚部署管可以类似地包括一对管，每个管用于一个管状盖构件(即T形杆锚)及其相应的丝线引导构件。管之间还可以有连接，从而允许两个T形杆锚之间的两条线之间的固定件/共同的线跨越在管之间。例如，沿着管可以有槽，用于共同的线/固定件沿其滑动。Similarly, in the case of a soft tissue anchoring system using two tubular cover members/T-bar anchors, each tubular cover member/T-bar anchor is connected by a common line (e.g., a single line extending between the respective central portions of the two tubular cover members, which is connected to an artificial line at the central portion of the line; or two lines, for example, each line is connected to the central portion of the respective tubular cover member and fixed to each other at the distal ends of their ends), then the anchor deployment tube can similarly include a pair of tubes, each tube for a tubular cover member (i.e., T-bar anchor) and its corresponding wire guide member. There can also be connections between the tubes, allowing a fixing/common line between the two lines between the two T-bar anchors to span between the tubes. For example, there can be grooves along the tubes for the common line/fixing member to slide along.
护套可以保持在锚部署管内，并且可以延伸至容纳端盖/管状盖构件的管。The sheath may be retained within the anchor deployment tube and may extend to the tube housing the end cap/tubular cover member.
软组织锚固系统可以是通过导管装置部署的瓣叶锚。一种可能的导管装置是配置为通过植入人造腱索线来修复心脏的装置，其中软组织锚固系统充当瓣叶锚，用于将人造腱索线连接到心脏瓣叶。在一个示例中，导管装置包括：壳体部分，其从导管装置的远端沿着导管装置的长度向导管装置的近端延伸；瓣叶锚(包括软组织锚固系统)，用于放置在心脏瓣膜的瓣叶中，其中，瓣叶锚被布置为与人造腱索线联接；以及瓣叶锚部署机构，用于部署瓣叶锚以将其附接到心脏的瓣叶。The soft tissue anchoring system can be a leaflet anchor deployed by a catheter device. One possible catheter device is a device configured to repair the heart by implanting artificial chords, wherein the soft tissue anchoring system acts as a leaflet anchor for connecting the artificial chords to the heart valve leaflets. In one example, the catheter device includes: a housing portion extending from the distal end of the catheter device along the length of the catheter device to the proximal end of the catheter device; a leaflet anchor (including a soft tissue anchoring system) for placement in the leaflet of a heart valve, wherein the leaflet anchor is arranged to be coupled to the artificial chords; and a leaflet anchor deployment mechanism for deploying the leaflet anchor to attach it to the leaflet of the heart.
瓣叶锚部署机构可以包括用于夹持心脏瓣膜的瓣叶的机械夹持装置，以及用于在部署到身体组织中之前容纳瓣叶锚的瓣叶锚管；夹持装置和瓣叶锚被布置成使得当在使用中夹持装置抓紧瓣叶时，软组织锚固系统可被推出瓣叶锚管以刺穿瓣叶并部署锚，如本文其他地方所述的，从而它将织物体固定在瓣叶中。The leaflet anchor deployment mechanism may include a mechanical clamping device for clamping the leaflets of a heart valve, and a leaflet anchor tube for accommodating the leaflet anchor prior to deployment into body tissue; the clamping device and the leaflet anchor are arranged so that when the clamping device grasps the leaflet during use, the soft tissue anchoring system can be pushed out of the leaflet anchor tube to pierce the leaflet and deploy the anchor, as described elsewhere herein, so that it fixes the fabric body in the leaflet.
机械夹持装置可以包括可旋转地联接到导管装置的主体的夹持臂，使得夹持臂可以相对于导管装置旋转，以将夹持臂的外端移离导管装置的主体。The mechanical clamping device may include a clamping arm rotatably coupled to the body of the catheter device such that the clamping arm may be rotated relative to the catheter device to move an outer end of the clamping arm away from the body of the catheter device.
夹持臂可以包括形成于夹持臂的基座中的狭槽。夹持臂可通过该狭槽可旋转地联接到主体，使得夹持臂配置为远离导管装置的主体平移。此平移将包括在上述夹持臂的旋转运动中/在上述旋转运动之外。The clamp arm may include a slot formed in a base of the clamp arm. The clamp arm may be rotatably coupled to the body via the slot such that the clamp arm is configured to translate away from the body of the catheter device. This translation will be included in/in addition to the rotational movement of the clamp arm.
通过允许夹持臂平移远离主体，可以提供并调节导管装置的主体和夹持臂之间的空间。这可以提供对所夹持的瓣叶的更好的抓握。例如，人类的瓣叶的厚度可能在1至3毫米之间，因此能够将夹持臂平移远离导管装置的主体以适应不同厚度的瓣叶可以改善导管装置的主体和夹持臂之间的瓣叶接触。By allowing the clamping arms to translate away from the body, a space between the body of the catheter device and the clamping arms can be provided and adjusted. This can provide a better grip on the clamped leaflets. For example, the thickness of human leaflets may be between 1 and 3 mm, so being able to translate the clamping arms away from the body of the catheter device to accommodate leaflets of varying thicknesses can improve leaflet contact between the body of the catheter device and the clamping arms.
此外，通过提供一种使夹持臂可平移离开导管装置的主体的装置，由于整个夹持臂表面可在一次平移运动中松开所夹持的瓣叶，因此瓣叶/身体软组织可更平稳地与夹持臂脱离；然后旋转以将瓣叶从导管装置的主体和夹持臂之间完全释放。In addition, by providing a device that allows the clamping arm to translate away from the body of the catheter device, the leaflet/soft body tissue can be more smoothly disengaged from the clamping arm because the entire surface of the clamping arm can release the clamped leaflet in one translational movement; and then rotate to completely release the leaflet from between the body of the catheter device and the clamping arm.
瓣叶锚管可形成在导管装置的主体中。因此，瓣叶锚可配置为从导管装置的主体并朝向夹持瓣叶的夹持臂部署。The leaflet anchor tube may be formed in the body of the catheter device. Thus, the leaflet anchor may be configured to be deployed from the body of the catheter device and toward the clamping arms that clamp the leaflets.
夹持臂可包括多个锯齿，所述锯齿被构造用于增加瓣叶与夹持臂之间的接触面积。锯齿可位于：夹持臂的第一部分上，该第一部分被构造为面向瓣叶锚管的开口；以及位于夹持臂的第二部分上，该第二部分被构造为面向导管装置的主体。The clamp arm may include a plurality of serrations configured to increase the contact area between the leaflet and the clamp arm. The serrations may be located on: a first portion of the clamp arm configured to face the opening of the leaflet anchor tube; and on a second portion of the clamp arm configured to face the body of the catheter device.
通过以这种方式提供围绕夹持臂的锯齿，夹持臂可以提供其自身与瓣叶之间的改进的抓握接触。例如，锯齿可以有效地沿圆周围绕夹持臂的被配置为接触瓣叶的表面。因此，瓣叶可以更好地由夹持臂支撑。By providing serrations around the clamp arm in this manner, the clamp arm can provide an improved gripping contact between itself and the leaflet. For example, the serrations can effectively circumferentially surround the surface of the clamp arm that is configured to contact the leaflet. Thus, the leaflet can be better supported by the clamp arm.
主体还可以包括形成在被构造成面向夹持臂的表面上的多个锯齿。在夹持臂和导管装置的主体上都设置锯齿可进一步提高夹持臂夹持瓣叶的力度。The main body may further include a plurality of serrations formed on a surface configured to face the clamping arm. Arranging serrations on both the clamping arm and the main body of the catheter device can further increase the strength of the clamping arm in clamping the valve leaflet.
锯齿优选是钝的，以尽量减少瓣叶被夹持时所遭受的创伤。锯齿可以是夹持臂的表面和/或导管装置的主体中不均匀和/或均匀分布的起伏，与例如平坦/平面表面相比，其增加了其表面积。The serrations are preferably blunt to minimize trauma to the leaflets when they are clamped. The serrations may be uneven and/or evenly distributed undulations in the surface of the clamping arms and/or the body of the catheter device, increasing their surface area compared to, for example, a flat/planar surface.
夹持臂可以包括内部空间，该内部空间被配置成接收从形成在导管装置的主体中的瓣叶锚管部署的丝线引导构件和/或臂部以及端盖。该内部空间可向夹持臂的被配置成接触瓣叶、并由夹持臂的侧壁界定的面敞开。The clamp arm may include an interior space configured to receive a wire guide member and/or arm and an end cap deployed from a leaflet anchor tube formed in the body of the catheter device. The interior space may be open to a face of the clamp arm configured to contact the leaflet and defined by a side wall of the clamp arm.
内部空间可有利于丝线引导构件的完全延伸，使得臂部和/或端盖完全穿过瓣叶并因此可靠地植入身体软组织中。The interior space may facilitate full extension of the wire guiding member so that the arms and/or end caps fully penetrate the leaflets and are thereby securely implanted in the body's soft tissue.
内部空间可包括配置为接收第一丝线引导构件的第一内部空间和配置为接收第二丝线引导构件的第二内部空间。第一和第二内部空间的开口可由配置为接触瓣叶的夹持部分隔开。提供夹持部分可增加瓣叶与夹持臂接触的表面积，从而增加在将多个臂部和/或端盖植入瓣叶期间瓣叶的稳定性。The interior space may include a first interior space configured to receive a first wire guide member and a second interior space configured to receive a second wire guide member. The openings of the first and second interior spaces may be separated by a clamping portion configured to contact the leaflet. Providing the clamping portion may increase the surface area of the leaflet in contact with the clamping arm, thereby increasing the stability of the leaflet during implantation of multiple arms and/or end caps into the leaflet.
在示例实施例中，瓣叶锚管被布置成通过从瓣叶的心房侧刺穿瓣叶来将瓣叶锚植入心脏瓣叶中。瓣叶可以是二尖瓣瓣叶或三尖瓣瓣叶。In an example embodiment, the leaflet anchor tube is arranged to implant the leaflet anchor in the heart valve leaflet by piercing the leaflet from the atrial side of the leaflet.The leaflet may be a mitral valve leaflet or a tricuspid valve leaflet.
该装置允许瓣叶被容易地夹住，并将新的索牢固地附接到瓣叶上。无需像WO2008/101113中那样使用真空和缝合线的复杂程序。如果需要，机械夹持装置可以多次打开和关闭，以释放和重新接合瓣叶，直到其处于放置锚所需的位置。The device allows the leaflet to be easily clamped and a new cable to be securely attached to the leaflet. There is no need for a complicated procedure using vacuum and sutures as in WO2008/101113. If necessary, the mechanical clamping device can be opened and closed multiple times to release and re-engage the leaflet until it is in the desired position for anchor placement.
WO2016/042022和WO2020/109596中所述的先前的导管装置通常设想通过从瓣叶的心室侧而不是心房侧刺穿瓣叶来将瓣叶锚植入心脏瓣叶中。然而，本申请人认识到，从瓣叶的心房侧植入瓣叶锚的导管装置提供了许多优点，而当从心脏瓣叶的心室侧植入瓣叶锚时，这些优点不会存在。Prior catheter devices described in WO2016/042022 and WO2020/109596 generally contemplate implanting the leaflet anchor in the heart valve leaflet by piercing the leaflet from the ventricular side of the leaflet rather than the atrial side. However, the present applicants have recognized that catheter devices that implant the leaflet anchor from the atrial side of the leaflet provide a number of advantages that would not exist when the leaflet anchor is implanted from the ventricular side of the heart valve leaflet.
当从瓣叶的心室侧植入时，瓣叶锚可能需要位于瓣叶的边缘附近，以便为扇动的瓣叶提供足够的支撑。相反，当从瓣叶的心房侧植入时，当瓣叶锚靠近于瓣叶的边缘或瓣叶环植入时，瓣叶锚可为瓣叶的边缘提供足够的支撑。When implanted from the ventricular side of the leaflet, the leaflet anchor may need to be located near the edge of the leaflet in order to provide adequate support for the flapping leaflet. Conversely, when implanted from the atrial side of the leaflet, the leaflet anchor may provide adequate support for the edge of the leaflet when implanted close to the edge of the leaflet or the leaflet annulus.
瓣叶锚植入位置的选择可能取决于多种因素，并且可能因患者而异。将瓣叶锚植入瓣叶的心房侧可为外科医生提供更大的灵活性，让他们能够选择将瓣叶锚植入何处，即能够将瓣叶锚植入瓣叶的边缘附近、瓣叶环附近或两者之间。The choice of leaflet anchor placement may depend on a variety of factors and may vary from patient to patient. Implanting the leaflet anchor on the atrial side of the leaflet provides the surgeon with greater flexibility in choosing where to implant the leaflet anchor, with the ability to implant the leaflet anchor near the edge of the leaflet, near the leaflet annulus, or in between.
靠近瓣环而非靠近瓣叶的边缘的瓣叶组织可能更不容易遭受与瓣叶锚植入相关的创伤。例如，靠近瓣叶环的组织可能比靠近瓣叶边缘的组织厚。当线被拉紧时，靠近瓣叶的瓣环的组织可能更能承受心动周期期间与人造腱索线相关的拉伸。Leaflet tissue near the annulus rather than near the edge of the leaflets may be less susceptible to trauma associated with leaflet anchor implantation. For example, tissue near the leaflet annulus may be thicker than tissue near the edge of the leaflets. Tissue near the annulus of the leaflets may be more able to withstand the stretching associated with the artificial chordal wires during the cardiac cycle when the wires are tightened.
通过从心房侧植入瓣叶锚，瓣叶锚能够被植入得更靠近心脏瓣叶的环，同时仍为瓣叶的边缘提供足够的支撑。By implanting the leaflet anchor from the atrial side, the leaflet anchor can be implanted closer to the annulus of the heart valve leaflet while still providing adequate support to the edges of the leaflet.
当使用人造腱索线来防止瓣叶反流(即二尖瓣反流或三尖瓣反流)时，该线通常会在两端被固定，一端位于心脏的乳头肌处/中，另一端位于瓣叶锚处。因此，如果瓣叶锚(软组织锚固系统)从心室侧植入瓣叶，则该线将延伸至乳头肌，而不会为瓣叶的边缘(即瓣叶的扇动端)提供任何支撑。然而，当从心房侧植入瓣叶时，该线可沿瓣叶的心房侧表面延伸，并在瓣叶的边缘之上延伸，然后下降到心室内到乳头肌中的植入位置。因此，通过将锚植入的靠近瓣叶的瓣环，该线可为瓣叶的扇动的边缘提供支撑。这也可以更好地复制位于心脏瓣膜的瓣叶的边缘附近的腱索的动作。When an artificial chord wire is used to prevent leaflet regurgitation (i.e., mitral regurgitation or tricuspid regurgitation), the wire is typically secured at both ends, with one end located at/in the papillary muscle of the heart and the other end located at the leaflet anchor. Therefore, if the leaflet anchor (soft tissue anchoring system) is implanted into the leaflet from the ventricular side, the wire will extend to the papillary muscle without providing any support for the edge of the leaflet (i.e., the flapping end of the leaflet). However, when the leaflet is implanted from the atrial side, the wire can extend along the atrial surface of the leaflet, extend over the edge of the leaflet, and then descend into the ventricle to the implantation position in the papillary muscle. Therefore, by implanting the anchor close to the annulus of the leaflet, the wire can provide support for the flapping edge of the leaflet. This can also better replicate the action of the chordae that are located near the edge of the leaflet of a heart valve.
瓣叶锚(软组织锚固系统)可被布置成展开，使得人造腱索线将在瓣叶锚和心脏瓣膜的瓣叶的边缘之间与心脏的瓣叶的心房侧接触。The leaflet anchor (soft tissue anchoring system) can be arranged to be deployed so that the artificial chord wire will contact the atrial side of the leaflet of the heart between the leaflet anchor and the edge of the leaflet of the heart valve.
当瓣叶锚从心房侧植入时，可以理解的是，当人造腱索线植入瓣叶的心房侧时，其可为扇动的边缘提供支撑，因为当线被植入时，该线将从心房侧通过瓣叶瓣膜在瓣叶边缘之上下降到心室侧。这在治疗扇动的的瓣叶(flai ling leaflet)时可能特别有益。When the leaflet anchor is implanted from the atrial side, it is appreciated that when the artificial chord wire is implanted on the atrial side of the leaflet, it can provide support for the flapping edge because when the wire is implanted, the wire will pass from the atrial side through the leaflet flap and drop over the leaflet edge to the ventricular side. This may be particularly beneficial when treating a flapping leaflet.
WO2016/042022和WO2020/109596所公开的先前的导管装置通常需要精确地将瓣叶锚(软组织锚固系统)植入瓣叶中，以便为瓣叶的边缘提供足够的支撑。由于瓣叶锚除了其自身的植入外，不会为瓣叶的边缘提供任何额外的支撑，因此锚的植入位置决定了为瓣叶的边缘提供多少支撑。因此，瓣叶锚的植入可能需要更精确，以确保为瓣叶的边缘提供足够的支撑。Previous catheter devices disclosed in WO2016/042022 and WO2020/109596 typically require precise implantation of leaflet anchors (soft tissue anchoring systems) into the leaflets in order to provide adequate support to the edges of the leaflets. Since the leaflet anchors do not provide any additional support to the edges of the leaflets other than their own implantation, the implantation location of the anchors determines how much support is provided to the edges of the leaflets. Therefore, implantation of the leaflet anchors may need to be more precise to ensure adequate support is provided to the edges of the leaflets.
然而，由于当瓣叶锚植入瓣叶的，心房侧时人造腱索与瓣叶的边缘接触，因此本发明的瓣叶锚的植入位置无需如此精确，因为无论瓣叶锚是靠近于瓣叶的边缘植入还是靠近于瓣叶的心房环植入，都会为瓣叶的边缘提供额外支撑。这可使瓣叶锚的植入更有效，因为瓣叶在心动周期中的运动(其可能会改变瓣叶锚的植入位置)对瓣叶锚提供的整体支撑的损害较小。However, since the artificial chordae are in contact with the edge of the leaflet when the leaflet anchor is implanted on the atrial side of the leaflet, the implantation position of the leaflet anchor of the present invention does not need to be so precise, because whether the leaflet anchor is implanted close to the edge of the leaflet or close to the atrial annulus of the leaflet, additional support is provided to the edge of the leaflet. This can make the implantation of the leaflet anchor more effective, because the movement of the leaflet during the cardiac cycle (which may change the implantation position of the leaflet anchor) will less impair the overall support provided by the leaflet anchor.
人造腱索线可具有不同的横截面积。人造腱索线可在远离瓣叶锚和/或被配置为位于乳头肌处/内的一端处具有第一横截面积。人造腱索线可在靠近和/或附接到瓣叶锚(软组织锚固系统)的一端处具有第二横截面积。The artificial chords may have different cross-sectional areas. The artificial chords may have a first cross-sectional area at one end distal to the leaflet anchor and/or configured to be located at/in the papillary muscle. The artificial chords may have a second cross-sectional area at one end proximal to and/or attached to the leaflet anchor (soft tissue anchoring system).
第一横截面积和第二横截面积可以不同。第二横截面积可以是矩形横截面积。第二横截面积可以是椭圆形横截面积。第二横截面积的长轴可以配置为与瓣叶锚的心房表面平行。第二横截面积可以大于第一横截面积。第一横截面积可以是圆形的。The first cross-sectional area and the second cross-sectional area may be different. The second cross-sectional area may be a rectangular cross-sectional area. The second cross-sectional area may be an elliptical cross-sectional area. The major axis of the second cross-sectional area may be configured to be parallel to the atrial surface of the leaflet anchor. The second cross-sectional area may be larger than the first cross-sectional area. The first cross-sectional area may be circular.
通过提供包含如讨论的第二横截面积的人造腱索线，可以增加人造线的与瓣叶的心房侧接触的表面积。因此，人造腱索线在植入时可以为扇动的瓣叶提供更大程度的支撑。By providing an artificial tendon line comprising a second cross-sectional area as discussed, the surface area of the artificial line in contact with the atrial side of the valve leaflet can be increased. Therefore, the artificial tendon line can provide a greater degree of support for the flapping valve leaflet when implanted.
人造腱索线可包括多条缝合线。所述多条缝合线可增加人造腱索线与瓣叶的心房侧之间的接触面积，从而由人造腱索线为扇动的瓣叶提供更大程度的支撑。此外，如果所述多条缝合线中的一条失效，则引入冗余，使得所述多条缝合线中的一条或更多条仍可成功植入。The artificial chords may include a plurality of sutures. The plurality of sutures may increase the contact area between the artificial chords and the atrial side of the leaflets, thereby providing a greater degree of support for the flapping leaflets by the artificial chords. In addition, if one of the plurality of sutures fails, redundancy is introduced so that one or more of the plurality of sutures may still be successfully implanted.
导管装置包括从导管装置的远端向近端延伸的壳体部分。导管装置的最远端可以是人造腱索线通常从其被植入的位置，而近端可以位于导管装置的相对端。导管装置通常可以沿着与从导管装置的近端到远端的延伸方向对齐的方向插入体内。The catheter device includes a housing portion extending from a distal end to a proximal end of the catheter device. The distal-most end of the catheter device may be the location from which the artificial chord wire is typically implanted, while the proximal end may be located at the opposite end of the catheter device. The catheter device may generally be inserted into the body in a direction aligned with the direction of extension from the proximal end to the distal end of the catheter device.
瓣叶锚(软组织锚固系统)可被布置成通过将其推出瓣叶锚管端部处的开口而进行部署，其中，该开口被布置成在部署期间与心脏瓣叶的心房侧接触。The leaflet anchor (soft tissue anchoring system) may be arranged to be deployed by pushing it out of an opening at the end of a leaflet anchor tube, wherein the opening is arranged to contact the atrial side of the heart valve leaflet during deployment.
使得在部署期间瓣叶锚管的开口被置于与心脏瓣叶的心房侧接触可以便于从瓣叶的心房侧植入瓣叶锚。例如，将开口置于与心房侧接触可以确保锚从其弹性折叠构型变为展开构型时的正确放置、定位和部署。Placing the opening of the leaflet anchor tube in contact with the atrial side of the heart valve leaflet during deployment can facilitate implantation of the leaflet anchor from the atrial side of the leaflet. For example, placing the opening in contact with the atrial side can ensure proper placement, positioning, and deployment of the anchor from its elastically folded configuration to its expanded configuration.
瓣叶锚(软组织锚固系统)可被布置成从导管装置的近端朝向导管装置的远端被推出瓣叶锚部署机构。The leaflet anchor (soft tissue anchor system) may be arranged to be pushed out of the leaflet anchor deployment mechanism from the proximal end of the catheter device toward the distal end of the catheter device.
导管装置可以包括用于部署瓣叶锚的线性杆。该线性杆可配置为将瓣叶锚推出瓣叶锚部署机构。线性杆可以是丝线引导构件。The catheter device may include a linear rod for deploying the leaflet anchor. The linear rod may be configured to push the leaflet anchor out of the leaflet anchor deployment mechanism. The linear rod may be a wire guide member.
WO2016/042022和WO2020/109596中公开的先前装置均教导了一种U形杆，其用于将瓣叶锚从瓣叶锚部署机构中推出。由于瓣叶锚部署在瓣叶的心室侧，即瓣叶下方，因此这些现有技术装置中的每一个都需要U形杆。然而，对于本装置，瓣叶锚(软组织锚固系统)可以配置为在瓣叶的心房侧植入。因此，从上方接近瓣叶，因此瓣叶锚在导管装置的远端方向上进行部署。换句话说，瓣叶锚的部署方向与导管装置接近心脏瓣叶的方向相同。Previous devices disclosed in WO2016/042022 and WO2020/109596 both teach a U-shaped rod for pushing the leaflet anchor out of the leaflet anchor deployment mechanism. Since the leaflet anchor is deployed on the ventricular side of the leaflet, i.e., below the leaflet, each of these prior art devices requires a U-shaped rod. However, with the present device, the leaflet anchor (soft tissue anchoring system) can be configured to be implanted on the atrial side of the leaflet. Therefore, the leaflet is approached from above, and thus the leaflet anchor is deployed in the distal direction of the catheter device. In other words, the deployment direction of the leaflet anchor is the same as the direction in which the catheter device approaches the heart leaflet.
因此，可以使用线性杆。线性杆是线性的，通常更容易制造。线性杆还可以更容易地沿着任何其他数量的丝线、杆等布置在导管装置中，以操作位于导管装置远端的其他组件。因此，线性杆可以简化导管装置的制造，特别是与之前的U形杆设计相比。丝线引导构件可以用作线性杆。Thus, a linear rod may be used. A linear rod is linear and generally easier to manufacture. A linear rod may also be more easily arranged in a catheter device along with any other number of wires, rods, etc. to operate other components at the distal end of the catheter device. Thus, a linear rod may simplify the manufacture of a catheter device, particularly compared to previous U-shaped rod designs. A wire guide member may be used as a linear rod.
导管装置通常可以从心脏的心房侧接近植入位置而不是由于导管装置插入心脏的已知技术而从心室侧接近植入位置。也就是说，在接近时，导管装置的远端将朝向心脏瓣叶的心房侧定向。因此，为了便于瓣叶锚在瓣叶的心房侧(其表面将被定向成朝向导管装置的近端)中的部署，瓣叶锚可以从导管装置的近端向导管装置的远端地被推出瓣叶锚部署机构。The catheter device can generally approach the implantation site from the atrial side of the heart rather than from the ventricular side due to known techniques for inserting the catheter device into the heart. That is, upon approach, the distal end of the catheter device will be oriented toward the atrial side of the heart valve leaflet. Therefore, to facilitate deployment of the leaflet anchor in the atrial side of the leaflet (whose surface will be oriented toward the proximal end of the catheter device), the leaflet anchor can be pushed out of the leaflet anchor deployment mechanism from the proximal end of the catheter device toward the distal end of the catheter device.
瓣叶锚管可形成于导管装置的主体中。瓣叶锚管可不形成于夹持装置中。瓣叶锚管的开口可位于导管装置的主体的表面上，使得瓣叶锚可从导管装置的主体部署。开口可定位成使得瓣叶锚从导管装置的圆周表面和/或侧面部署。The leaflet anchor tube may be formed in the body of the catheter device. The leaflet anchor tube may not be formed in the clamping device. The opening of the leaflet anchor tube may be located on the surface of the body of the catheter device so that the leaflet anchor can be deployed from the body of the catheter device. The opening may be positioned so that the leaflet anchor is deployed from the circumferential surface and/or the side of the catheter device.
如上所述，夹持臂可包括内部空间，该内部空间被配置成接收从形成在导管装置的主体中的瓣叶锚管部署的臂部和/或端盖以及丝线引导构件。该内部空间可向夹持臂的被配置成接触瓣叶、并由夹持臂的侧壁界定的面敞开。As described above, the clamp arm may include an interior space configured to receive an arm portion and/or an end cap and a wire guide member deployed from a leaflet anchor tube formed in the body of the catheter device. The interior space may be open to a face of the clamp arm configured to contact the leaflet and defined by a side wall of the clamp arm.
瓣叶锚管通常可沿导管装置的主体的长度延伸。瓣叶锚管还可具有沿导管装置的半径延伸的部件，使得瓣叶锚可从导管装置的圆周表面上的位置从导管装置部署。The leaflet anchor tube may generally extend along the length of the body of the catheter device. The leaflet anchor tube may also have a portion extending along a radius of the catheter device so that the leaflet anchor may be deployed from the catheter device from a location on the circumferential surface of the catheter device.
本申请人已经意识到，在导管装置的主体中而不是在夹持装置中形成瓣叶锚管可以带来许多以前未知的优点。Applicants have appreciated that forming the leaflet anchoring tubes in the body of the catheter device rather than in the clamping device may provide a number of previously unknown advantages.
在WO2020/109596和WO2016/042022中设想了一种导管装置，该导管装置包括夹持臂，其中瓣叶锚管形成在该装置的夹持臂中。为了能够将瓣叶锚管容纳在夹持臂内，夹持臂因此比现有技术装置中的瓣叶锚更长。夹持臂为容纳瓣叶锚而延长的长度以及从夹持臂部署的位置会有效减少瓣叶锚可以植入瓣叶的深度范围。In WO2020/109596 and WO2016/042022, a catheter device is envisioned, which includes a clamping arm, wherein the leaflet anchor tube is formed in the clamping arm of the device. In order to be able to accommodate the leaflet anchor tube within the clamping arm, the clamping arm is therefore longer than the leaflet anchor in the prior art device. The extended length of the clamping arm to accommodate the leaflet anchor and the position from which the clamping arm is deployed effectively reduce the depth range at which the leaflet anchor can be implanted in the leaflet.
当瓣叶锚管形成在导管装置的主体中时，夹持臂的长度可能比处于折叠构型时的瓣叶锚短。这是可能的，因为瓣叶锚(软组织锚固系统)不容纳在夹持臂内。当对夹持臂施加相同的力时，较短的夹持臂可能能够比较长的夹持臂更用力地抓住瓣叶。当瓣叶锚在瓣叶中靠近夹持臂的大致远端的位置部署时，使用较短的夹持臂可以减小与部署锚相关的力矩。因此，在植入锚期间，瓣叶可以更牢固地被保持就位。When the leaflet anchor tube is formed in the body of the catheter device, the length of the clamping arm may be shorter than the leaflet anchor when in the folded configuration. This is possible because the leaflet anchor (soft tissue anchoring system) is not contained within the clamping arm. When the same force is applied to the clamping arm, the shorter clamping arm may be able to grasp the leaflet more forcefully than the longer clamping arm. When the leaflet anchor is deployed in the leaflet near the approximately distal end of the clamping arm, the use of a shorter clamping arm can reduce the torque associated with deploying the anchor. Therefore, the leaflet can be held in place more securely during implantation of the anchor.
另外，或者作为替代，瓣叶锚的长度可以不受夹持臂长度的限制。因此，当瓣叶锚管形成在导管装置的主体中时，可以使用比夹持臂长度更长的瓣叶锚。与较短的锚相比，较长的瓣叶锚在植入时能够固定和/或支撑心脏瓣叶的较大部分。Additionally, or alternatively, the length of the leaflet anchor may not be limited by the length of the clamping arm. Thus, when the leaflet anchor tube is formed in the body of the catheter device, a leaflet anchor that is longer than the length of the clamping arm may be used. A longer leaflet anchor may be able to secure and/or support a larger portion of a heart valve leaflet when implanted than a shorter anchor.
夹持臂可布置成与瓣叶锚管的开口相接。瓣叶锚管可形成在主体中，使得当夹持臂被保持抵靠导管的主体时，夹持臂的表面与瓣叶锚管的开口相接。瓣叶锚管的开口可与夹持臂的远端相接。瓣叶锚管的开口可夹持臂的与位于夹持臂远端的表面相接。The clamp arm may be arranged to interface with the opening of the leaflet anchor tube. The leaflet anchor tube may be formed in the body so that when the clamp arm is held against the body of the catheter, a surface of the clamp arm interfaces with the opening of the leaflet anchor tube. The opening of the leaflet anchor tube may interface with the distal end of the clamp arm. The opening of the leaflet anchor tube may interface with a surface of the clamp arm located at the distal end of the clamp arm.
通过将夹持臂布置成与瓣叶锚管的开口相接，瓣叶锚可以更可靠地部署在心脏中的所需位置。例如，当夹持臂抓住瓣叶时，瓣叶可以保持在夹持臂和瓣叶锚管之间，使得瓣叶锚(软组织锚固系统)可以在夹持的位置处部署到瓣叶中。定位成靠着瓣叶的近端侧的夹持臂可以在部署锚时提供抵靠瓣叶的阻力，使得瓣叶在部署期间受到适当的约束。By arranging the clamping arms to interface with the openings of the leaflet anchor tubes, the leaflet anchors can be more reliably deployed at a desired location in the heart. For example, when the clamping arms grasp the leaflets, the leaflets can be held between the clamping arms and the leaflet anchor tubes so that the leaflet anchors (soft tissue anchoring systems) can be deployed into the leaflets at the clamped location. The clamping arms positioned against the proximal side of the leaflets can provide resistance against the leaflets when deploying the anchors so that the leaflets are properly constrained during deployment.
或者，瓣叶锚管可容纳在夹持臂内。瓣叶锚管的开口可位于夹持臂的端部并朝向导管的远端定向。Alternatively, the leaflet anchor tube may be housed within the clamping arm. The opening of the leaflet anchor tube may be located at the end of the clamping arm and oriented toward the distal end of the catheter.
在此布置中，应理解，夹持臂可以铰接在导管装置的近端，而夹持臂的远端朝向导管装置的远端。因此，与WO2016/042022和WO2020/109596中公开的夹持臂相反，夹持臂可以定向成使得瓣叶锚(软组织锚固系统)被配置为沿导管的远端方向而不是近端方向部署。In this arrangement, it will be appreciated that the clamp arm may be hinged at the proximal end of the catheter device, with the distal end of the clamp arm facing the distal end of the catheter device. Thus, in contrast to the clamp arms disclosed in WO2016/042022 and WO2020/109596, the clamp arm may be oriented such that the leaflet anchor (soft tissue anchoring system) is configured to be deployed in the distal direction of the catheter rather than in the proximal direction.
位于夹持臂中的瓣叶锚管的开口可配置为与导管装置的主体的互补表面相接。这样，当瓣叶被夹持臂抓住时，导管装置的主体可在锚(软组织锚固系统)部署时对瓣叶提供阻力，使得瓣叶在部署期间受到适当的约束。The opening of the leaflet anchor tube in the clamping arm can be configured to engage with a complementary surface of the body of the catheter device. In this way, when the leaflet is grasped by the clamping arm, the body of the catheter device can provide resistance to the leaflet when the anchor (soft tissue anchoring system) is deployed, so that the leaflet is properly constrained during deployment.
夹持臂可配置为抓紧瓣叶，使得瓣叶锚管布置成将瓣叶锚靠近于瓣叶的瓣环植入。当瓣叶锚管形成在导管装置或夹持臂的主体中时，夹持臂可按这种方式配置。The clamping arms can be configured to grasp the leaflets so that the leaflet anchoring tube is arranged to implant the leaflet anchors proximate to the annulus of the leaflets. The clamping arms can be configured in this manner when the leaflet anchoring tube is formed in the body of the catheter device or the clamping arms.
例如，夹持臂可以夹持瓣叶，使得瓣叶锚管的开口靠近于瓣叶的瓣环而定位。当瓣叶锚管位于导管装置的主体中时，夹持臂可以从心室侧夹持瓣叶，使得夹持臂的远端在瓣叶的心室环处或接近于瓣叶的心室环与瓣叶接触，并且瓣叶锚管的开口在心房侧位于瓣叶的瓣环处或接近于瓣叶的瓣环。当瓣叶锚管位于夹持臂中时，夹持臂可以从心房侧夹持瓣叶，使得夹持臂的远端在瓣叶的心房环处或接近于瓣叶的心房环而与瓣叶接触，并且因此瓣叶锚管的开口位于瓣叶的心房环处或接近于瓣叶的心房环。For example, the clamping arm can clamp the leaflet so that the opening of the leaflet anchoring tube is positioned close to the annulus of the leaflet. When the leaflet anchoring tube is located in the body of the catheter device, the clamping arm can clamp the leaflet from the ventricular side so that the distal end of the clamping arm contacts the leaflet at or close to the ventricular annulus of the leaflet, and the opening of the leaflet anchoring tube is located at or close to the annulus of the leaflet on the atrial side. When the leaflet anchoring tube is located in the clamping arm, the clamping arm can clamp the leaflet from the atrial side so that the distal end of the clamping arm contacts the leaflet at or close to the atrial annulus of the leaflet, and the opening of the leaflet anchoring tube is therefore located at or close to the atrial annulus of the leaflet.
夹持臂可以另外或替代地配置为夹持瓣叶，使得瓣叶锚管布置成将瓣叶锚靠近于瓣叶的边缘植入。当瓣叶锚管形成在导管装置或夹持臂的主体中时，夹持臂可以以这种方式配置。The clamping arm may additionally or alternatively be configured to clamp the leaflet such that the leaflet anchoring tube is arranged to implant the leaflet anchor proximate to the edge of the leaflet. The clamping arm may be configured in this manner when the leaflet anchoring tube is formed in the body of the catheter device or the clamping arm.
导管装置可以包括用于夹持臂的铰链机构，其中，铰链机构与主体的材料一体地形成并且通过该材料的弹性变形而旋转离开主体。The catheter device may comprise a hinge mechanism for the clamping arm, wherein the hinge mechanism is formed integrally with the material of the body and is rotated away from the body by elastic deformation of the material.
可以提供单根丝线来致动夹持臂，通过弯曲铰链机构来使夹持臂的端部旋转离开主体，并且如果没有力施加到丝线上，则夹持臂弹性地返回到其静止位置。A single wire may be provided to actuate the clamping arm, the end of the clamping arm being rotated away from the body by bending the hinge mechanism, and the clamping arm being resiliently returned to its rest position if no force is applied to the wire.
夹持臂可用单根丝线或多根丝线致动。如果夹持臂的铰链机构与主体的材料一体形成并通过该材料的弹性变形而旋转离开主体，则可以获得优势。夹持臂以及铰链机构可与主体的材料一体形成。或者，夹持臂可包括单独形成的臂段，例如铣削件或激光切割件，其中，该单独的臂段通过例如胶合或焊接附接到主体的铰链机构。The clamping arm may be actuated by a single thread or by a plurality of threads. Advantages may be obtained if the hinge mechanism of the clamping arm is formed integrally with the material of the body and is swiveled away from the body by elastic deformation of the material. The clamping arm as well as the hinge mechanism may be formed integrally with the material of the body. Alternatively, the clamping arm may comprise a separately formed arm segment, e.g. a milled or laser cut piece, wherein the separate arm segment is attached to the hinge mechanism of the body by, e.g. gluing or welding.
在一些示例中，导管装置的主体可以由弹性金属(例如镍钛合金)制成，铰链由弹性金属中形成的弹性接合部提供。在这种情况下，可以使用单根丝线来使夹持臂弹性地变形：通过弯曲与主体的弹性接合部，使夹持臂的端部远离主体而旋转，一旦没有力施加到丝线上，夹持臂就弹性地返回到其静止位置。这样做的优点之一是，当丝线上的力释放时，夹持臂的弹力可以将其保持抵靠导管装置的主体，而无需拉动单独的丝线来保持对瓣叶的牢固抓握。但是，如果需要，可以使用第二根丝线作为备用。In some examples, the body of the catheter device can be made of a resilient metal (e.g., nickel-titanium alloy), and the hinge is provided by a resilient joint formed in the resilient metal. In this case, a single wire can be used to elastically deform the clamping arm: by bending the resilient joint with the body, the end of the clamping arm is rotated away from the body, and once no force is applied to the wire, the clamping arm elastically returns to its resting position. One of the advantages of this is that when the force on the wire is released, the elastic force of the clamping arm can hold it against the body of the catheter device without having to pull a separate wire to maintain a firm grip on the leaflet. However, if necessary, a second wire can be used as a backup.
在其他示例中，导管装置的主体可以由复合材料制成，例如碳或玻璃增强PEEK。然后可以使用销接合部将夹持臂连接到导管装置的主体，其中，销形成夹持臂的旋转轴线。本文提到的销接合部可以是旋转接合部或铰链接合部，即，包括相互匹配的特征，销或圆柱形构件连接所述构件，销形成接合部的旋转轴线。In other examples, the body of the catheter device can be made of a composite material, such as carbon or glass reinforced PEEK. The clamp arm can then be connected to the body of the catheter device using a pin joint, wherein the pin forms the axis of rotation of the clamp arm. The pin joint referred to herein can be a rotational joint or a hinge joint, i.e., comprising mutually matching features, a pin or cylindrical member connecting the members, the pin forming the axis of rotation of the joint.
可选地或另外地，夹持臂可以热定型为“超过闭合(more than closed)”配置。这将允许夹持臂将组织抓向装置的主体。Alternatively or additionally, the clamping arms may be heat set to a "more than closed" configuration. This will allow the clamping arms to grasp tissue toward the body of the device.
为了将夹持臂和铰链与导管装置的主体一体成型，导管的主体可以包括外管，夹持臂形成为外管的铰接部分。可在管中形成多种形式的狭缝和/或图案，以提供弱化的铰链部分，从而允许弯曲而不会使夹持臂塑性变形。In order to form the clamping arm and hinge integrally with the body of the catheter device, the body of the catheter may include an outer tube with the clamping arm formed as a hinged portion of the outer tube. Various forms of slits and/or patterns may be formed in the tube to provide a weakened hinge portion to allow bending without plastic deformation of the clamping arm.
在替代布置中，可以使用铰接夹持臂。在这种情况下，夹持臂可以是铣削的，在这种情况下，可以用弹簧致动进行闭合，用丝线来打开，或反之亦然，或者用两根丝线(一根用于打开，一根用于闭合)进行致动。装置中的滑轮切口可用于改变拉线的拉力方向。In an alternative arrangement, an articulated clamping arm may be used. In this case, the clamping arm may be milled, in which case actuation may be spring-actuated for closing and wire-actuated for opening, or vice versa, or actuated by two wires (one for opening and one for closing). Pulley cutouts in the device may be used to change the direction of the wire pull.
夹持臂的夹持表面可布置成利用摩擦力保持瓣叶。例如，夹持表面可使用具有高摩擦系数的材料和/或夹持表面可具有用于增加摩擦力的纹理或表面轮廓，例如脊状或锯齿状轮廓。The gripping surface of the gripping arm may be arranged to retain the leaflet using friction. For example, the gripping surface may use a material with a high coefficient of friction and/or the gripping surface may have a texture or surface profile for increasing friction, such as a ridged or serrated profile.
壳体部分可以是两部分式壳体部分。导管装置可以包括：两部分式壳体部分，其从导管装置的远端沿着导管装置的长度向导管装置的近端延伸，两部分式壳体部分包括位于导管装置的远端处的远端部分和位于远端部分的近端侧的近端部分；瓣叶锚部署机构位于壳体部分的近端部分处；乳突锚部署机构位于壳体部分的远端部分处，用于部署乳突锚以附接至乳头肌，其中，乳突锚部署机构布置用于通过相对于远端部分沿远端方向向外移动乳突锚来部署乳突锚；以及位于两部分式壳体部分的近端部分和远端部分之间的柔性接合部，其中，柔性接合部允许远端部分的中心线相对于近端部分的中心线成一定角度。The housing portion may be a two-part housing portion. The catheter device may include: a two-part housing portion extending from a distal end of the catheter device along the length of the catheter device to a proximal end of the catheter device, the two-part housing portion including a distal portion located at the distal end of the catheter device and a proximal portion located on the proximal side of the distal portion; a leaflet anchor deployment mechanism located at the proximal portion of the housing portion; a mastoid anchor deployment mechanism located at the distal portion of the housing portion for deploying the mastoid anchor for attachment to the papillary muscle, wherein the mastoid anchor deployment mechanism is arranged to deploy the mastoid anchor by moving the mastoid anchor outwardly in a distal direction relative to the distal portion; and a flexible joint located between the proximal portion and the distal portion of the two-part housing portion, wherein the flexible joint allows a centerline of the distal portion to be angled relative to a centerline of the proximal portion.
可将两部分式壳体部分布置成在使用导管装置期间被同时放置在乳头肌和心脏的瓣叶之间。The two-part housing portion may be arranged to be placed simultaneously between a papillary muscle and a valve leaflet of the heart during use of the catheter device.
夹持臂可设置在两部分式壳体部分的近端部分中，并可旋转地联接到导管装置。夹持臂可由上述任何一种机构旋转地联接。The clamp arm may be disposed in the proximal portion of the two-part housing portion and rotatably coupled to the catheter device. The clamp arm may be rotatably coupled by any of the mechanisms described above.
两部分式壳体部分可以由任何合适材料(即医学上合适的材料)的两个管状部分形成。可以使用不锈钢或镍钛合金。或者，可以使用复合材料，例如碳纤维或玻璃纤维增强PEEK。导管装置可以通过此类材料的组合而形成，其中，装置不同部分的材料的选择取决于这些部分所需的特性。优选允许超声波穿过且同时具有足够强度的材料，碳增强PEEK可以很好地满足这些要求，并且还可以对组件进行注塑成型，从而降低制造成本。纤维增强塑料通常在X射线下不可见，因此可以使用策略性地放置在所有组件中的不透射线标记来确定装置组件在X射线上相对于彼此的位置和方向，作为超声成像的补充信息。The two-part housing portion can be formed by two tubular portions of any suitable material (i.e., medically suitable material). Stainless steel or nickel-titanium alloys can be used. Alternatively, composite materials such as carbon fiber or glass fiber reinforced PEEK can be used. The catheter device can be formed by a combination of such materials, wherein the selection of materials for different parts of the device depends on the properties required for these parts. It is preferred to allow ultrasound to pass through and at the same time have a material of sufficient strength, and carbon reinforced PEEK can meet these requirements well, and the components can also be injection molded, thereby reducing manufacturing costs. Fiber-reinforced plastics are generally not visible under X-rays, so non-transmissive markers strategically placed in all components can be used to determine the position and orientation of the device components relative to each other on X-rays as supplementary information for ultrasound imaging.
柔性接合部可包括铰链元件，例如，两部分式壳体部分的远端部分通过枢转机构或弹性变形元件与近端部分联接。例如，壳体部分的两部分可以是通过铰链元件联接在一起的复合材料或金属部件。The flexible joint may comprise a hinge element, for example, the distal portion of the two-part housing portion is coupled to the proximal portion via a pivot mechanism or an elastically deformable element. For example, the two parts of the housing portion may be composite or metal components coupled together via a hinge element.
乳突锚在部署之前可以容纳在壳体部分的远端部分内。乳突锚可以具有与壳体部分的远端部分类似的横截面。例如，当锚保持在远端部分中时，两者可以具有管状形式。如上所述，锚可以具有折叠和展开构型，从而允许锚的销在部署乳突锚期间在身体组织内形成钩。乳突锚部署机制可以采用与WO2016/042022或WO2020/109596中类似的形式。The mastoid anchor can be housed within the distal portion of the housing portion prior to deployment. The mastoid anchor can have a similar cross-section to the distal portion of the housing portion. For example, when the anchor is retained in the distal portion, both can have a tubular form. As described above, the anchor can have a folded and unfolded configuration, allowing the pin of the anchor to form a hook within body tissue during deployment of the mastoid anchor. The mastoid anchor deployment mechanism can take a form similar to that in WO2016/042022 or WO2020/109596.
在一个示例中，乳突锚部署机构包括第一丝线或杆，用于将乳突锚相对于两部分式壳体部分的远端部分推向远端方向。此外，还可以有第二丝线或杆，用于将乳突锚从乳突锚部署机构释放，以便在将乳突锚植入身体组织(即乳头肌的组织和/或乳头肌附近的组织)后将乳突锚从导管装置脱开。In one example, the mastoid anchor deployment mechanism includes a first wire or rod for pushing the mastoid anchor in a distal direction relative to the distal portion of the two-part housing portion. In addition, there may be a second wire or rod for releasing the mastoid anchor from the mastoid anchor deployment mechanism so as to disengage the mastoid anchor from the catheter device after implanting the mastoid anchor in body tissue (i.e., tissue of the papillary muscle and/or tissue near the papillary muscle).
乳突锚可具有附接于其上的腱索线，并且可包括锁定机构，例如WO2016/042022或WO2020/109596中的锁定环，该锁定机构用于在未对锁定机构施加力时夹紧腱索线。锁定环可以能够弹性变形以将线从锁定机构释放，从而调整腱索线的长度。乳突锚部署机构可包括锁定环支架，用于将锁定环保持在其弹性变形的位置，其中乳突锚部署机构布置成选择性地将锁定环支架从锁定环撤出，使得在部署乳突锚之后以及在对腱索线的长度进行任何必要的调整之后，腱索线可锁定就位。The mastoid anchor may have a chord line attached thereto and may include a locking mechanism, such as a locking ring in WO2016/042022 or WO2020/109596, for clamping the chord line when no force is applied to the locking mechanism. The locking ring may be capable of elastically deforming to release the line from the locking mechanism, thereby adjusting the length of the chord line. The mastoid anchor deployment mechanism may include a locking ring bracket for maintaining the locking ring in its elastically deformed position, wherein the mastoid anchor deployment mechanism is arranged to selectively withdraw the locking ring bracket from the locking ring so that the chord line can be locked in place after the mastoid anchor is deployed and after any necessary adjustment to the length of the chord line.
瓣叶锚部署机构可允许在通过具有抓握装置的弹出单元将锚署到瓣叶之后收回并重新定位瓣叶锚(软组织锚固系统)，该抓握装置具有：第一构型，该第一构型被布置成允许瓣叶锚部署到瓣叶中而无需瓣叶锚脱离弹出单元；以及第二构型，在该第二构型中，瓣叶锚可逆地从弹出单元释放；其中，在第一构型中，弹出单元的抓握装置抓住瓣叶锚的近端，同时瓣叶锚的远端不受抓握装置的阻碍，以使其能够植入瓣叶中；并且其中，在第二构型中，弹出单元的夹持装置与瓣叶锚脱离。The leaflet anchor deployment mechanism allows the leaflet anchor to be retracted and repositioned (soft tissue anchoring system) after being deployed to the leaflet by a pop-up unit having a grasping device, the grasping device having: a first configuration, which is arranged to allow the leaflet anchor to be deployed into the leaflet without the leaflet anchor being detached from the pop-up unit; and a second configuration, in which the leaflet anchor is reversibly released from the pop-up unit; wherein, in the first configuration, the grasping device of the pop-up unit grasps the proximal end of the leaflet anchor, while the distal end of the leaflet anchor is not obstructed by the grasping device to enable it to be implanted into the leaflet; and wherein, in the second configuration, the clamping device of the pop-up unit is detached from the leaflet anchor.
可以通过拉动腱索使瓣叶锚折叠到收回管内，从而将瓣叶锚(软组织锚系统)收回到收回管/导管内。收回管可以放置在仅附接到瓣叶(装置被移除)的腱索的顶部，或放置在位置不佳(部分接合、自由浮动、缠绕等)的瓣叶锚的顶部。收回管可以是可偏转的轴，其末端有或没有柔性部分(允许末端找到瓣叶锚基部，以允许收回)。或者，收回轴可以是柔性管，其布置成与瓣叶锚的基部接合。The leaflet anchor (soft tissue anchor system) can be retracted into the retrieval tube/catheter by pulling on the chords to cause the leaflet anchor to fold into the retrieval tube. The retrieval tube can be placed on top of the chords that are only attached to the leaflets (the device is removed), or on top of a leaflet anchor that is poorly positioned (partially engaged, free floating, entangled, etc.). The retrieval tube can be a deflectable shaft with or without a flexible portion at the end (allowing the end to find the base of the leaflet anchor to allow retrieval). Alternatively, the retrieval shaft can be a flexible tube that is arranged to engage with the base of the leaflet anchor.
从本发明的第六方面来看，提供了一种植入根据第一方面的软组织锚固系统的方法，该方法包括：使用丝线引导构件接合管状盖构件；使用丝线引导构件将管状盖构件推过身体组织；拉出丝线引导构件；并且当线沿远离组织的表面的方向穿过组织时对线施加拉力，使得管状盖构件抵靠在身体软组织上。From the sixth aspect of the present invention, a method for implanting a soft tissue anchoring system according to the first aspect is provided, the method comprising: engaging a tubular cover member using a wire guide member; pushing the tubular cover member through body tissue using the wire guide member; pulling out the wire guide member; and applying tension to the wire as the wire passes through the tissue in a direction away from the surface of the tissue so that the tubular cover member rests against the soft body tissue.
本发明第六方面的方法可具有与本发明第一方面的软组织锚固系统的特征相对应的一个或更多个特征。因此，上述第一方面的软组织锚固系统的描述，包括但不限于所有技术优点和替代实施例，可同样适用于第六方面的方法。The method of the sixth aspect of the present invention may have one or more features corresponding to the features of the soft tissue anchoring system of the first aspect of the present invention. Therefore, the description of the soft tissue anchoring system of the first aspect above, including but not limited to all technical advantages and alternative embodiments, may also apply to the method of the sixth aspect.
从本发明的第七方面来看，提供了一种制造根据第一方面的软组织锚固系统的方法，该方法包括：制造管状盖构件；以及将线固定到管状盖构件上，使线从其中央部分延伸。From a seventh aspect of the invention, there is provided a method of manufacturing the soft tissue anchoring system according to the first aspect, the method comprising: manufacturing a tubular cover member; and securing a wire to the tubular cover member so that the wire extends from a central portion thereof.
制造管状盖构件可以包括：加工外管状构件；加工内管状构件；将线固定在外管状构件和内管状构件之间；以及将内管状构件装配在外管状构件中。Manufacturing the tubular cover member may include: machining the outer tubular member; machining the inner tubular member; fixing the wire between the outer tubular member and the inner tubular member; and fitting the inner tubular member into the outer tubular member.
或者，当管状盖构件为单个整体式部件时，制造管状盖构件可包括用激光切割或加工由单块镍钛诺或不锈钢制成的管状盖构件。Alternatively, when the tubular cover member is a single, unitary component, manufacturing the tubular cover member may include laser cutting or machining the tubular cover member from a single piece of Nitinol or stainless steel.
本发明第七方面的方法可具有与本发明第一方面的软组织锚固系统的特征相对应的一个或更多个特征。因此，上述第一方面的软组织锚固系统的描述，包括但不限于所有技术优点和替代实施例，可同样适用于第七方面的方法。The method of the seventh aspect of the present invention may have one or more features corresponding to the features of the soft tissue anchoring system of the first aspect of the present invention. Therefore, the description of the soft tissue anchoring system of the first aspect above, including but not limited to all technical advantages and alternative embodiments, may also apply to the method of the seventh aspect.
从本发明的第八方面来看，提供了一种根据第二方面将软组织锚固系统植入身体软组织中的方法，该方法包括：使用相应的丝线引导构件接合每个臂部；使用相应的丝线引导构件将每个臂部推动通过身体组织；拉出每个丝线引导构件；以及将每个臂部折叠成朝向基部塌缩，使得身体组织被夹在基部和每个臂部之间。From the eighth aspect of the present invention, a method for implanting a soft tissue anchoring system into body soft tissue according to the second aspect is provided, the method comprising: engaging each arm using a corresponding wire guide member; pushing each arm through body tissue using a corresponding wire guide member; pulling out each wire guide member; and folding each arm to collapse toward a base so that body tissue is clamped between the base and each arm.
本发明的第八方面的方法可具有与本发明第二方面的软组织锚固系统的特征相对应的一个或更多个特征。因此，上述第二方面的软组织锚固系统的描述，包括但不限于所有技术优点和替代实施例，可同样适用于第八方面的方法。The method of the eighth aspect of the present invention may have one or more features corresponding to the features of the soft tissue anchoring system of the second aspect of the present invention. Therefore, the description of the soft tissue anchoring system of the second aspect above, including but not limited to all technical advantages and alternative embodiments, may also apply to the method of the eighth aspect.
从本发明的第九方面来看，提供了一种制造根据第二方面的软组织锚固系统的方法，该方法包括：制造U形织物体；以及将每个臂部配置为以折叠方式塌缩。From a ninth aspect of the present invention, there is provided a method of manufacturing the soft tissue anchoring system according to the second aspect, the method comprising: manufacturing a U-shaped fabric body; and configuring each arm to collapse in a folded manner.
制作U形织物体可以包括激光切割织物。织物可以从包括以下项的组中选择：聚酯；PET；UHMPE；EPTFE；PTFE等。Making the U-shaped fabric body may include laser cutting the fabric.The fabric may be selected from the group consisting of: polyester; PET; UHMPE; EPTFE; PTFE, and the like.
本发明第九方面的方法可具有与本发明第二方面的软组织锚固系统的特征相对应的一个或更多个特征。因此，上述第二方面的软组织锚固系统的描述，包括但不限于所有技术优点和替代实施例，可同样适用于第九方面的方法。The method of the ninth aspect of the present invention may have one or more features corresponding to the features of the soft tissue anchoring system of the second aspect of the present invention. Therefore, the description of the soft tissue anchoring system of the second aspect above, including but not limited to all technical advantages and alternative embodiments, may also apply to the method of the ninth aspect.
从本发明的第十方面来看，提供了一种在身体软组织中植入根据第三方面的软组织锚固系统的方法，该方法包括：将每个锚固构件植入身体软组织中；以及通过对公共系绳点施加拉力来对每条系绳线施加拉力。From the tenth aspect of the present invention, a method of implanting the soft tissue anchoring system according to the third aspect in body soft tissue is provided, the method comprising: implanting each anchoring member in the body soft tissue; and applying tension to each tether line by applying tension to a common tether point.
从本发明的第十一方面来看，提供了一种根据第三方面的软组织锚固系统的制造方法，该方法包括：将每条系绳线连接到相应的锚固构件；以及将每条系绳线连接到公共系绳点。From an eleventh aspect of the present invention, there is provided a method of manufacturing the soft tissue anchoring system according to the third aspect, the method comprising: connecting each tether line to a corresponding anchoring member; and connecting each tether line to a common tether point.
从本发明的第十二方面来看，提供了一种通过植入人造腱索线来修复心脏的方法，该方法包括：利用第三或第四方面的导管装置植入软组织锚固系统。From the twelfth aspect of the present invention, there is provided a method for repairing a heart by implanting artificial chords, the method comprising: implanting a soft tissue anchoring system using the catheter device of the third or fourth aspect.
本发明的第十二方面的方法可具有与本发明第三或第四方面的导管装置的特征相对应的一个或更多个特征。因此，上述第三和/或第四方面的导管装置的描述，包括但不限于所有技术优点和替代实施例，可同样适用于第十二方面的方法。The method of the twelfth aspect of the present invention may have one or more features corresponding to the features of the catheter device of the third or fourth aspect of the present invention. Therefore, the description of the catheter device of the third and/or fourth aspects above, including but not limited to all technical advantages and alternative embodiments, may also apply to the method of the twelfth aspect.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
现在将仅通过示例并参考附图来描述本发明的某些示例实施例，附图中：Certain example embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:
图1示出了通过二尖瓣插入导管装置的过程；FIG1 illustrates the process of inserting a catheter device through the mitral valve;
图2至图6示出了采用两个夹持臂的机械夹持机构的动作；Figures 2 to 6 illustrate the action of a mechanical clamping mechanism using two clamping arms;
图7示出了利用一个夹持臂夹持二尖瓣的瓣叶；FIG7 shows a mitral valve leaflet being clamped using a clamping arm;
图8至图12示出了利用弹出装置在装置中部署瓣叶锚定件；8 to 12 illustrate deployment of leaflet anchors in a device using an ejection device;
图13示出了在放置锚期间瓣膜的近距离视图，该锚联接至人造腱索线；FIG13 shows a close-up view of the valve during placement of anchors coupled to the synthetic chordal wires;
图14示出了导管装置的远端部向乳头肌的运动，以放置乳突锚；FIG14 illustrates movement of the distal end of the catheter device toward the papillary muscle to place the mastoid anchor;
图15示出了撤回装置的治疗导管部分以及利用可选的调节导管来调节索长；FIG15 illustrates withdrawing the treatment catheter portion of the device and adjusting the cable length using an optional adjustment catheter;
图16和图17示出了用于穿有缝合线的锚的钩的示例；16 and 17 show examples of hooks for anchors threaded with sutures;
图18和图19示出了乳突锚的一种示例的折叠和展开构型；18 and 19 illustrate an example folded and unfolded configuration of a mastoid anchor;
图20示出了在将瓣叶锚植入心脏瓣膜的瓣叶的心房表面之后，导管装置的取出；FIG20 illustrates removal of the catheter device after implantation of the leaflet anchors into the atrial surface of the leaflets of the heart valve;
图21示出了被布置用于将瓣叶锚植入心脏瓣膜的瓣叶的心房表面的导管装置；FIG21 shows a catheter device arranged for implanting a leaflet anchor into the atrial surface of a leaflet of a heart valve;
图22示出了导管装置的替代布置，其被布置用于将瓣叶锚植入心脏瓣膜的瓣叶的心房表面中；FIG. 22 shows an alternative arrangement of a catheter device arranged for implanting a leaflet anchor into the atrial surface of a leaflet of a heart valve;
图23示出了改进的夹持装置，用于在未展开构型中夹持心脏瓣膜的瓣叶；FIG23 shows an improved clamping device for clamping leaflets of a heart valve in an undeployed configuration;
图24示出了改进的夹持装置，用于在展开构型中夹持心脏瓣膜的瓣叶；FIG24 shows an improved clamping device for clamping leaflets of a heart valve in an expanded configuration;
图25示出了一种织物体锚固系统；FIG25 shows a fabric body anchoring system;
图26示出了一种织物体锚固系统的端盖的详细视图；FIG26 shows a detailed view of an end cap of a fabric body anchoring system;
图27A示出了在二尖瓣瓣叶的植入过程中的织物体锚固系统；FIG27A shows a fabric body anchoring system during implantation of a mitral valve leaflet;
图27B从心室侧视角示出了植入二尖瓣瓣叶之后的织物体锚固系统；FIG27B shows the fabric body anchoring system after implantation of the mitral valve leaflets from a ventricular side perspective;
图27C从心房侧视角示出了植入二尖瓣瓣叶后的织物体锚固系统；FIG27C shows the fabric anchoring system after implantation into the mitral valve leaflets from an atrial perspective;
图28示出了织物体锚固系统的端盖，每个端盖均与丝线引导构件接合；FIG28 shows the end caps of the fabric body anchoring system, each end cap being engaged with a wire guide member;
图29A示出了在二尖瓣瓣叶中的植入过程中织物体锚固系统的替代端盖布置；FIG29A illustrates an alternative end cap arrangement for a fabric body anchoring system during implantation in a mitral valve leaflet;
图29B示出了图29A中所示的织物体锚固系统的端盖布置的详细视图；FIG. 29B shows a detailed view of the end cap arrangement of the fabric body anchoring system shown in FIG. 29A ;
图30A和图30B示出了织物体锚固系统的一种替代端盖布置；30A and 30B illustrate an alternative end cap arrangement for the fabric body anchoring system;
图31A和图31B示出了织物体锚固系统的一种替代端盖布置；31A and 31B illustrate an alternative end cap arrangement for the fabric body anchoring system;
图32A和图32B示出了织物体锚固系统的一种替代端盖布置；32A and 32B illustrate an alternative end cap arrangement for the fabric body anchoring system;
图33A示出了处于第一构型中的织物体锚固系统的一种替代端盖布置；FIG33A shows an alternative end cap arrangement for the fabric body anchoring system in a first configuration;
图33B示出了图33A中的端盖布置处于第二构型中；FIG33B shows the end cap arrangement of FIG33A in a second configuration;
图34示出了与织物体锚固系统的端盖接合的丝线引导构件；FIG34 shows a wire guide member engaged with an end cap of a fabric body anchoring system;
图35A至图35I示出了植入过程中处于各个阶段的原型织物体锚固系统；35A to 35I illustrate a prototype fabric body anchoring system at various stages during implantation;
图36A示出了U形织物体锚固系统的示意图；FIG36A shows a schematic diagram of a U-shaped fabric body anchoring system;
图36B和图36C以平面图示出了图36A中所示的织物体锚定系统的原型；36B and 36C show in plan view a prototype of the fabric body anchoring system shown in FIG. 36A ;
图37A至图37C示出了容纳在导管装置的递送轴内的软组织锚固系统的各种示意图；37A-37C show various schematic views of a soft tissue anchoring system housed within a delivery shaft of a catheter device;
图38示出了用于织物体锚固系统的回收机构；Fig. 38 shows a retrieval mechanism for a fabric body anchoring system;
图39A至图39D示出了织物体锚固系统的回收的步骤；39A to 39D illustrate the steps of recovering the fabric body anchoring system;
图40示出了一种替代端盖布置方式；Figure 40 shows an alternative end cap arrangement;
图41示出了一种原型软组织锚固系统的平面图；FIG41 shows a plan view of a prototype soft tissue anchoring system;
图42示出了另一种端盖布置方式；Figure 42 shows another end cap arrangement;
图43A至图43D示出了在植入身体软组织的步骤中的替代软组织锚固系统；43A to 43D illustrate an alternative soft tissue anchoring system in the steps of implantation into soft body tissue;
图44示出了具有凸起部分的丝线引导构件被管状盖构件接收；FIG44 shows a wire guiding member having a raised portion being received by a tubular cover member;
图45示意性地呈现了用于植入一对锚固构件的部署系统；FIG45 schematically presents a deployment system for implanting a pair of anchor members;
图46A示出了植入二尖瓣瓣叶中的软组织锚固系统；以及FIG. 46A shows a soft tissue anchoring system implanted in a mitral valve leaflet; and
图46B示出了处于线的拉力下的图46A的软组织锚固系统。46B shows the soft tissue anchor system of FIG. 46A under tension of the wire.
具体实施方式DETAILED DESCRIPTION
以下描述详述了与上述锚固系统的描述一致且可与之结合的一个或更多个特征。本文讨论的以下实施例不应被孤立地看待，也不意在是限制性的，而应在本公开内容的整个上下文的情况下来看待，同时考虑附图。The following description details one or more features consistent with and combinable with the above description of the anchoring system.The following embodiments discussed herein should not be viewed in isolation nor are they intended to be limiting, but rather should be viewed in the context of the entire disclosure while considering the drawings.
本文介绍的导管装置用于非手术(血管内)插入二尖瓣索，以解决瓣膜的瓣叶12脱垂引起的二尖瓣反流。图中示出了用于此目的的不同形式的导管装置2，但应理解，在植入瓣叶锚10和乳突锚9方面，每种装置的一般原理是相同的，瓣叶锚可以用下文进一步描述的、根据本发明的任何软组织锚固系统来替代，乳突锚9用于将一个或更多个人造腱索线14插入心脏。人造腱索线14固定到脱垂的瓣叶12和乳头肌26上，从而重建正常的身体结构。单个导管装置2用于放置瓣叶锚10(或如下文进一步描述的软组织锚固系统)和乳突锚9。可以再次使用相同的导管装置2来调整索14的长度，以消除二尖瓣反流。因此，这种导管装置使得能够使用单个微创血管内手术来修复二尖瓣，与需要更多侵入性手术和/或多次操作的早期系统相比具有显著优势。The catheter device described herein is used for non-surgical (intravascular) insertion of mitral valve chords to address mitral valve regurgitation caused by prolapse of the valve leaflets 12 of the valve. The figure shows different forms of catheter devices 2 for this purpose, but it should be understood that the general principles of each device are the same in terms of implanting the leaflet anchors 10 and mastoid anchors 9, and the leaflet anchors can be replaced by any soft tissue anchoring system according to the present invention as further described below, and the mastoid anchors 9 are used to insert one or more artificial tendon chords 14 into the heart. The artificial tendon chords 14 are fixed to the prolapsed leaflets 12 and the papillary muscles 26, thereby reconstructing the normal body structure. A single catheter device 2 is used to place the leaflet anchors 10 (or the soft tissue anchoring system as further described below) and the mastoid anchors 9. The same catheter device 2 can be used again to adjust the length of the chord 14 to eliminate mitral valve regurgitation. Therefore, this catheter device enables the use of a single minimally invasive endovascular procedure to repair the mitral valve, which has significant advantages over earlier systems that require more invasive surgery and/or multiple operations.
应当注意的是，尽管血管内方法是优选的并且因此装置能够使用这种方法，但是该装置当然可以用于不同的手术，包括更具侵入性的手术。许多优点将保留，并且在需要更具侵入性的手术的情况下使用该装置可能是有益的。此外，如上所述，可以设想，乳突锚9或下文描述的软组织锚固系统的设计的各方面可以用于针对其他目的的锚，并且本公开内容不意在在这方面受到限制。It should be noted that while the endovascular approach is preferred and the device is therefore capable of using this approach, the device can certainly be used for different procedures, including more invasive procedures. Many of the advantages will be retained, and it may be beneficial to use the device in situations where a more invasive procedure is required. In addition, as described above, it is contemplated that aspects of the design of the mastoid anchor 9 or the soft tissue anchoring system described below can be used for anchors for other purposes, and the present disclosure is not intended to be limited in this regard.
下文描述的导管装置2可用于通过静脉系统、从腹股沟中的股静脉开始插入二尖瓣索。导管被推进至右心房。然后通过所谓的房间隔穿刺进入左心房，随后将较大的导引导管推进至左心房。然后通过导引导管将用于心脏修复的导管装置2引入左心房。The catheter device 2 described below can be used to insert the mitral valve cord through the venous system, starting from the femoral vein in the groin. The catheter is advanced to the right atrium. The left atrium is then entered through a so-called transseptal puncture, and a larger guiding catheter is subsequently advanced to the left atrium. The catheter device 2 for cardiac repair is then introduced into the left atrium through the guiding catheter.
使用X射线和超声引导来定位该装置，如下文更详细地解释的，抓住二尖瓣瓣叶12，并使用自膨胀的瓣叶锚10或下文所述的任何软组织锚固系统附接人造腱索线14。然后使用乳突锚9将人造腱索线14附接到乳头肌26。现在可以调节索的长度以消除任何二尖瓣反流。然后切断多余的索并取出所有的导管。使用超声和多普勒成像来执行该过程并监测结果。成功使用这种血管内技术将大大降低二尖瓣修复的侵入性、并发症和成本。Using X-ray and ultrasound guidance to position the device, as explained in more detail below, the mitral valve leaflets 12 are grasped and the artificial chords 14 are attached using the self-expanding leaflet anchors 10 or any of the soft tissue anchoring systems described below. The artificial chords 14 are then attached to the papillary muscles 26 using the mastoid anchors 9. The length of the cord can now be adjusted to eliminate any mitral regurgitation. The excess cord is then cut and all catheters are removed. Ultrasound and Doppler imaging are used to perform the procedure and monitor the results. Successful use of this endovascular technique will greatly reduce the invasiveness, complications, and cost of mitral valve repair.
下面将结合附图详细说明该装置的结构和功能。该装置的一种形式的使用过程可概括如下：The structure and function of the device will be described in detail below with reference to the accompanying drawings. The use process of one form of the device can be summarized as follows:
1)采用标准Seldinger技术进入股静脉并引入导引导管。1) The femoral vein was accessed and a guiding catheter was introduced using the standard Seldinger technique.
2)在X射线的引导下将导引导管推进至右心房。2) Under X-ray guidance, the guide catheter is advanced into the right atrium.
3)在X线和经食管超声的引导下，穿过房间隔后进入左心房。3) Under the guidance of X-ray and transesophageal ultrasound, the atrial septum is penetrated and the left atrium is entered.
4)确认左心房中的入口位置正确，以确保正确对准，用于插入导引导管和治疗导管。扩张房间隔的入口孔，并将导引导管推进到左心房中。4) Confirm that the entry point in the left atrium is correct to ensure proper alignment for insertion of the guide catheter and treatment catheter. The entry hole in the atrial septum is dilated and the guide catheter is advanced into the left atrium.
5)治疗导管装置2通过导引导管推进并定位在二尖瓣上方的左心房中。5) The treatment catheter device 2 is advanced through the guide catheter and positioned in the left atrium above the mitral valve.
6)利用超声波定位二尖瓣瓣叶12的脱垂部分，并将治疗导管装置2推进到左心室中，将治疗导管装置2的夹持器6放置到位以夹持住该脱垂部分。6) Using ultrasound to locate the prolapsed portion of the mitral valve leaflet 12, the treatment catheter device 2 is advanced into the left ventricle, and the clamp 6 of the treatment catheter device 2 is placed in place to clamp the prolapsed portion.
7)夹持住脱垂部分，在确保位置正确后，将瓣叶锚10推动通过瓣叶12，使其打开并固定瓣叶12，或者部署下面描述的软组织锚固系统。7) Clamp the prolapsed portion and, after ensuring the correct position, push the leaflet anchor 10 through the leaflet 12 to open and fix the leaflet 12, or deploy the soft tissue anchoring system described below.
8)可以在瓣叶通过弹出单元36保持与导管装置2附接的同时，测试瓣叶与锚的连接，并且如果连接充分，则将导管的远端部进一步推进到左心室中。8) The connection of the leaflets to the anchors can be tested while the leaflets remain attached to the catheter device 2 via the ejection unit 36, and if the connection is adequate, the distal end of the catheter is advanced further into the left ventricle.
9)将乳突锚9推入乳头肌26区域并推出其壳体8，从而使乳突锚9在乳头肌26内打开。9) Push the mastoid anchor 9 into the papillary muscle 26 area and push out its housing 8 , so that the mastoid anchor 9 opens inside the papillary muscle 26 .
10)如果夹持器6仍然夹持着瓣叶12，则将其释放，例如通过将瓣叶锚12从弹出单元36释放。10) If the gripper 6 still holds the leaflet 12 , it is released, for example by releasing the leaflet anchor 12 from the ejection unit 36 .
11)调整人造腱索线14的长度，直至二尖瓣反流消除。11) Adjust the length of the artificial chordae 14 until the mitral valve regurgitation is eliminated.
12)将导管装置2从乳突锚9拉回，并通过超声心动图再次确认二尖瓣反流的消除。12) Pull the catheter device 2 back from the mastoid anchor 9 and reconfirm the elimination of mitral regurgitation by echocardiography.
13)人造腱索线14的位置锁定在乳突锚9处。13) The position of the artificial chord 14 is locked at the mastoid anchor 9.
14)剪断多余的腱索线14。14) Cut off the excess tendon 14.
15)如果需要，可以放置额外的人造腱索线。15) Additional synthetic chordae can be placed if necessary.
16)导管装置完全撤出并从血管系统中移除。16) The catheter device is completely withdrawn and removed from the vascular system.
图1至图19示出了WO2020/109596公开的示例性导管装置2。虽然WO2020/109596中公开的导管装置2被用于从二尖瓣瓣叶12的心室侧植入瓣叶锚9和人造腱索线14，但示例性导管装置12的许多特征和/或部件可与本发明的导管装置102兼容，或者可根据本发明的教导进行修改，使得瓣叶锚110和人造腱索线114可从瓣叶12的心房侧植入瓣叶12中，如图20至图22所示。1 to 19 show an exemplary catheter device 2 disclosed in WO2020/109596. Although the catheter device 2 disclosed in WO2020/109596 is used to implant the leaflet anchor 9 and the artificial chord line 14 from the ventricular side of the mitral valve leaflet 12, many features and/or components of the exemplary catheter device 12 may be compatible with the catheter device 102 of the present invention, or may be modified according to the teachings of the present invention so that the leaflet anchor 110 and the artificial chord line 114 may be implanted into the leaflet 12 from the atrial side of the leaflet 12, as shown in FIGS. 20 to 22.
图1示出了导引导管22，其被用于引导导管装置2至心脏内的所需位置，邻近延伸穿过二尖瓣，因此位于两个瓣叶12之间。导管装置2由四个不同的主要部分组成；可操纵导管、夹持壳体4、夹持装置6和乳突锚壳体8，该乳突锚壳体8保持乳突锚9。夹持壳体4和乳突锚壳体8可形成两部分式壳体部分的近端部分4和远端部分8，该两部分式壳体部分具有中央柔性和可伸缩的接合部34，如图2至图6、图14和图20至图22所示。因此，应当理解，图1中所示的过程(以及图7、图13和图15中所示的过程)可将该布置用于夹持壳体(近端部分)4和乳突锚壳体(远端部分)8。可操纵导管可以用替代布置来替换，该替代布置使用围绕可操纵导管的可操纵护套和可操纵导管内的柔性管。FIG. 1 shows a guide catheter 22 which is used to guide a catheter device 2 to a desired location within the heart, proximal to extend through the mitral valve and therefore between the two leaflets 12. The catheter device 2 is comprised of four distinct main parts; a steerable catheter, a clamp housing 4, a clamp device 6 and a mastoid anchor housing 8 which holds a mastoid anchor 9. The clamp housing 4 and mastoid anchor housing 8 may form a proximal portion 4 and a distal portion 8 of a two-part housing portion having a central flexible and retractable joint 34 as shown in FIGS. 2 to 6, 14 and 20 to 22. It should therefore be understood that the process shown in FIG. 1 (as well as the processes shown in FIGS. 7, 13 and 15) may use this arrangement for the clamp housing (proximal portion) 4 and the mastoid anchor housing (distal portion) 8. The steerable catheter may be replaced with an alternative arrangement using a steerable sheath surrounding the steerable catheter and a flexible tube within the steerable catheter.
图1示出了夹持装置6闭合的一个示例性导管装置的前视图。一些布置的夹持装置6使用单个夹持臂30，该夹持臂30将瓣叶12夹持靠在夹持壳体部分4上，如图7所示。在其他布置中，夹持装置6使用两个夹持臂30、32，如图2至图6所示，以便允许瓣叶12在与导管装置主体间隔开的点处被夹持在两个夹持臂30、32之间。夹持装置6是瓣叶锚部署机构的一部分，用于部署瓣叶锚10或下文讨论的软组织锚固系统，以将其附接到心脏的瓣叶12。在图中的示例中，夹持装置6包括瓣叶锚管38，用于在部署之前以折叠构型容纳瓣叶锚10。在示例实施例中，瓣叶锚管38位于(第一)夹持臂30中，例如，如图2和图4所示。当夹持装置6抓住瓣叶12时，瓣叶锚10可被推出瓣叶锚管38以刺入瓣叶12并使瓣叶锚10形成为展开构型，使得瓣叶锚10的钩状结构40将其固定在瓣叶12中。或者，如下文所述，可以通过穿刺瓣叶来植入软组织锚固系统，如后面的图中所示。FIG1 shows a front view of an exemplary catheter device with the clamping device 6 closed. Some arrangements of the clamping device 6 use a single clamping arm 30 that clamps the leaflet 12 against the clamping housing portion 4, as shown in FIG7 . In other arrangements, the clamping device 6 uses two clamping arms 30, 32, as shown in FIGS. 2 to 6 , so as to allow the leaflet 12 to be clamped between the two clamping arms 30, 32 at a point spaced apart from the catheter device body. The clamping device 6 is part of a leaflet anchor deployment mechanism for deploying the leaflet anchor 10 or the soft tissue anchoring system discussed below to attach it to the leaflet 12 of the heart. In the example in the figure, the clamping device 6 includes a leaflet anchor tube 38 for accommodating the leaflet anchor 10 in a folded configuration prior to deployment. In an exemplary embodiment, the leaflet anchor tube 38 is located in the (first) clamping arm 30, for example, as shown in FIGS. 2 and 4 . When the clamping device 6 grasps the leaflet 12, the leaflet anchor 10 can be pushed out of the leaflet anchor tube 38 to penetrate the leaflet 12 and form the leaflet anchor 10 into an expanded configuration so that the hook structure 40 of the leaflet anchor 10 fixes it in the leaflet 12. Alternatively, as described below, the soft tissue anchoring system can be implanted by puncturing the leaflet, as shown in the following figures.
瓣叶锚10或下文讨论的软组织锚固系统连接到人造腱索线14，该人造腱索线14可位于沿第一夹持臂30的表面延伸的窄通道内(例如，如图8至图12所示)，并通过乳突锚壳体8到达乳突锚9(例如，如图20至图22所示)。通道可略小于人造腱索线14的直径和/或具有薄的屏蔽结构(未示出)。这使得人造腱索线14由于摩擦配合而就位。人造腱索线14进入乳突锚壳体8并通过乳突锚锁定部分，通过锁定和切割件。人造腱索线14可附接到沿导管向后一直延伸到外部的丝线(以使调节更平稳)。由于丝线可以被推动通过导管，因此在手术过程中可以通过拉动来缩短索的长度，或者延长索。The leaflet anchor 10 or the soft tissue anchoring system discussed below is connected to an artificial chord line 14, which may be located in a narrow channel extending along the surface of the first clamping arm 30 (e.g., as shown in Figures 8 to 12) and reaches the mastoid anchor 9 through the mastoid anchor housing 8 (e.g., as shown in Figures 20 to 22). The channel may be slightly smaller than the diameter of the artificial chord line 14 and/or have a thin shielding structure (not shown). This allows the artificial chord line 14 to be in place due to friction fit. The artificial chord line 14 enters the mastoid anchor housing 8 and passes through the mastoid anchor locking portion, through the locking and cutting piece. The artificial chord line 14 can be attached to a silk thread that extends all the way back along the catheter to the outside (to make the adjustment smoother). Since the silk thread can be pushed through the catheter, the length of the cable can be shortened or extended by pulling during the operation.
具有夹持壳体(近端部分)4和乳突锚壳体(远端部分)8的该两部分式壳体部分的直径可约为6-7毫米，长度约为30毫米。The two-part housing portion with the clamp housing (proximal portion) 4 and the mastoid anchor housing (distal portion) 8 may be approximately 6-7 mm in diameter and approximately 30 mm in length.
图2至图6示出了在具有如上所述的两个夹持臂30、32的示例中，夹持机构6移动过程中的步骤。该夹持机构6是壳体部分的一部分，该壳体部分还包括柔性和可伸缩的接合部，使得乳突锚壳体8(远端部分)在瓣叶12被夹持机构6抓住后能够朝向乳头肌26移动。在该示例中，为了抓握住瓣叶12，第一夹持臂30旋转以使其端部42远离导管装置的主体，该旋转通过主体的管状形式的薄弱区域44实现。可以看出，瓣叶锚管38位于第一夹持臂30内，瓣叶锚管38的端部在第一夹持臂30的端部42处具有开口。当第一夹持臂30打开时，第二夹持臂32可自由旋转以将其端部46移出主体。在此示例中，第二夹持臂32围绕由销48形成的铰链旋转，销48位于两部分式壳体部分的近端部分4中的孔中，但应理解，其端部46的类似最终放置可通过滑动运动实现。当第二夹持臂32向外折叠时，第一夹持臂30可闭合，使得两个端部42、46在与装置的主体隔开的点处接触。这允许抓握住瓣叶12。当瓣叶12就位时，瓣叶锚10可从瓣叶锚管38中移出以进行植入，例如通过如下文关于图8至图12描述的带有弹出单元36的机构，瓣叶锚10的最终定位与图13中所示的类似。2 to 6 show the steps during the movement of the clamping mechanism 6 in an example with two clamping arms 30, 32 as described above. The clamping mechanism 6 is part of a housing portion which also includes a flexible and retractable joint, allowing the mastoid anchor housing 8 (distal portion) to be moved towards the papillary muscle 26 after the leaflet 12 has been grasped by the clamping mechanism 6. In this example, in order to grasp the leaflet 12, the first clamping arm 30 is rotated so that its end 42 is away from the body of the catheter device, the rotation being achieved by a weakened area 44 of the tubular form of the body. It can be seen that the leaflet anchor tube 38 is located inside the first clamping arm 30, the end of which has an opening at the end 42 of the first clamping arm 30. When the first clamping arm 30 is open, the second clamping arm 32 is free to rotate to move its end 46 out of the body. In this example, the second clamping arm 32 rotates about a hinge formed by a pin 48 located in a hole in the proximal portion 4 of the two-part housing portion, but it will be appreciated that a similar final placement of its end 46 may be achieved by a sliding motion. When the second clamping arm 32 is folded outwardly, the first clamping arm 30 may be closed so that the two ends 42, 46 are in contact at a point spaced from the body of the device. This allows the leaflets 12 to be grasped. When the leaflets 12 are in place, the leaflet anchor 10 may be removed from the leaflet anchor tube 38 for implantation, for example by a mechanism with an ejection unit 36 as described below with respect to FIGS. 8 to 12 , the final positioning of the leaflet anchor 10 being similar to that shown in FIG. 13 .
图7示出了夹持机构6的替代形式，其利用单个夹持臂抓住瓣叶12，并将瓣叶保持靠在夹持壳体4上。这也可以使用图8至图12中的弹出单元36机构。Figure 7 shows an alternative form of clamping mechanism 6 which utilizes a single clamping arm to grasp the leaflet 12 and hold it against the clamping housing 4. This can also be used with the ejection unit 36 mechanism of Figures 8 to 12.
可以提供夹持臂30、32上的脊状表面以帮助其夹持瓣叶12。可以使用3D超声波和/或其他可用源来确认夹持机构6已抓住瓣叶12的正确部分。Ridged surfaces on the gripping arms 30, 32 may be provided to assist them in gripping the leaflets 12. 3D ultrasound and/or other available sources may be used to confirm that the gripping mechanism 6 has grasped the correct portion of the leaflets 12.
夹持机构6可以根据需要多次打开和关闭，以抓住瓣叶12的正确部分。打开和关闭可以通过允许一根丝线拉开夹持机构6并且一根丝线将其拉动闭合的系统来实现。可以使用不同的丝线和/或杆布置来控制如上所述的具有两个夹持臂30、32的示例。一旦确认了夹持机构6的位置，就可以将瓣叶锚10推出瓣叶锚管38的端部，例如通过拉动导管另一端中的丝线。图13示出了放置在瓣叶12中的瓣叶锚10的近视图，其中，钩状结构40与瓣叶12接合。The clamping mechanism 6 can be opened and closed as many times as necessary to grasp the correct portion of the leaflet 12. Opening and closing can be achieved by a system that allows one wire to pull the clamping mechanism 6 open and one wire to pull it closed. Different wire and/or rod arrangements can be used to control the example with two clamping arms 30, 32 as described above. Once the position of the clamping mechanism 6 is confirmed, the leaflet anchor 10 can be pushed out of the end of the leaflet anchor tube 38, for example by pulling on the wire in the other end of the catheter. Figure 13 shows a close-up view of the leaflet anchor 10 placed in the leaflet 12, wherein the hook structure 40 is engaged with the leaflet 12.
如上所述，可以使用如图8至图12所示的弹出单元36。使用弹出单元36，瓣叶锚部署机构允许在将锚10部署到瓣叶12中之后缩回和重新定位瓣叶锚10。这是通过弹出单元36实现的，弹出单元36包括具有第一构型(如图8和图9所示)和第二构型(如图10和图11所示)的抓握装置50。As described above, a pop-up unit 36 as shown in Figures 8 to 12 may be used. Using the pop-up unit 36, the leaflet anchor deployment mechanism allows the leaflet anchor 10 to be retracted and repositioned after the anchor 10 is deployed into the leaflet 12. This is achieved by the pop-up unit 36, which includes a grasping device 50 having a first configuration (as shown in Figures 8 and 9) and a second configuration (as shown in Figures 10 and 11).
如果医生对测试过程中的连接不满意(例如，如果锚10移动的过多和/或对线上的力的阻力不足)，则可以收回瓣叶锚10并将其放置在另一个位置。If the physician is not satisfied with the connection during testing (eg, if the anchor 10 moves too much and/or provides insufficient resistance to forces on the wire), the leaflet anchor 10 may be retrieved and placed in another location.
在瓣叶锚管38的壁中设有凹槽52，用于引导弹出单元36。凹槽52确保弹出单元36在沿管移动时相对于管38保持单一方向。凹槽52可以对弹出单元36的移动范围设定最大限制，从而可以防止其在任一方向过远地移出或移入瓣叶锚管38。弹出单元36具有用于与凹槽52接合的导销56。凹槽52中的缩窄部54用作指示器，以让操作员知道弹出单元36何时到达某个位置。导销56的尺寸和缩窄部54的宽度被设定为使得销56与凹槽52中的缩窄部54的接合将需要更大的力才能进行进一步移动，从而为操作的医生提供触觉反馈。A groove 52 is provided in the wall of the leaflet anchoring tube 38 for guiding the ejection unit 36. The groove 52 ensures that the ejection unit 36 maintains a single orientation relative to the tube 38 as it moves along the tube. The groove 52 can set a maximum limit to the range of movement of the ejection unit 36, thereby preventing it from moving too far out of or into the leaflet anchoring tube 38 in either direction. The ejection unit 36 has a guide pin 56 for engaging with the groove 52. The narrowing 54 in the groove 52 serves as an indicator to let the operator know when the ejection unit 36 has reached a certain position. The size of the guide pin 56 and the width of the narrowing 54 are set so that the engagement of the pin 56 with the narrowing 54 in the groove 52 will require more force for further movement, thereby providing tactile feedback to the operating physician.
图8至图12中的瓣叶锚部署机构还包括线推进器58，用于在部署锚10期间引导人造腱索线14离开和远离瓣叶锚管38。线推进器58引导人造腱索线离开瓣叶锚管38，以便更容易地对其进行后续操作，例如，用于收紧线14或用于拉动植入的瓣叶锚10以测试连接。线推进器58在瓣叶锚10的部署动作期间被致动，当瓣叶锚10从弹出单元36释放时触发该致动。因此，当弹出单元36从植入的瓣叶锚10撤回时，线推进器50被释放。The leaflet anchor deployment mechanism of Figures 8 to 12 also includes a wire pusher 58 for guiding the artificial chord wire 14 out of and away from the leaflet anchor tube 38 during the deployment of the anchor 10. The wire pusher 58 guides the artificial chord wire out of the leaflet anchor tube 38 to make it easier to perform subsequent operations on it, for example, for tightening the wire 14 or for pulling the implanted leaflet anchor 10 to test the connection. The wire pusher 58 is actuated during the deployment action of the leaflet anchor 10, and the actuation is triggered when the leaflet anchor 10 is released from the pop-up unit 36. Therefore, when the pop-up unit 36 is withdrawn from the implanted leaflet anchor 10, the wire pusher 50 is released.
在所示示例中，线推进器58从受约束状态过渡到不受约束状态，并径向向外移动以将线14推出，一旦来自瓣叶锚10的约束被解除，这种径向向外移动被允许，并且线推进器被释放。线推进器58是一种臂，该臂从弹出单元轴向向前且朝向瓣叶锚10延伸，并且当该臂处于静置状态且未被施加任何力时，其径向向外延伸出瓣叶锚管38。In the example shown, the wire pusher 58 transitions from a constrained state to an unconstrained state and moves radially outward to push the wire 14 out, and once the constraint from the leaflet anchor 10 is released, this radial outward movement is allowed and the wire pusher is released. The wire pusher 58 is an arm that extends axially forward from the ejection unit and toward the leaflet anchor 10, and when the arm is in a rest state and no force is applied to it, it extends radially outward from the leaflet anchor tube 38.
当瓣叶锚10或下文讨论的软组织锚固系统被植入瓣叶12中后，将治疗导管端部处的乳突锚壳体8放置在乳头肌26上。可以使用柔性和可伸缩的接合部34完成此操作，如图14所示。在此示例中，柔性和可伸缩的接合部34由切割成主体的管状形式的柔性弯曲部分形成。柔性和可伸缩的接合部36与管状远端部分8和管状近端部分4一体地形成，管状远端部分8提供乳突锚壳体8，管状近端部分4提供夹持壳体4。此外，管状夹持壳体4可以包括一体形成的夹持臂30，管的弱化部分44提供铰接部。柔性和可伸缩的接合部34可通过丝线和/或杆60延伸(或通过调节导管21，其也可推出乳突锚9)，这可施加力以延伸接合部34的弹性元件。该延伸用于移动在其壳体部分8内的乳突锚9，以将其抵靠或靠近乳头肌26放置，因为当接合部34延伸时，丝线/杆连同远端壳体部分8内的乳突锚8一起随壳体8移动。这可能是由于乳突锚9(或乳突锚推管)与壳体部分的远端部分8的内表面之间的摩擦。该位置可通过3D超声和/或其他可用源确认。After the leaflet anchor 10 or the soft tissue anchoring system discussed below is implanted in the leaflet 12, the mastoid anchor housing 8 at the end of the treatment catheter is placed on the papillary muscle 26. This operation can be accomplished using a flexible and retractable joint 34, as shown in Figure 14. In this example, the flexible and retractable joint 34 is formed by a flexible curved portion cut into the tubular form of the body. The flexible and retractable joint 36 is formed integrally with the tubular distal portion 8 and the tubular proximal portion 4, the tubular distal portion 8 providing the mastoid anchor housing 8 and the tubular proximal portion 4 providing the clamping housing 4. In addition, the tubular clamping housing 4 may include an integrally formed clamping arm 30, and the weakened portion 44 of the tube provides a hinge. The flexible and retractable joint 34 can be extended by a wire and/or rod 60 (or by adjusting the catheter 21, which can also push out the mastoid anchor 9), which can apply a force to extend the elastic element of the joint 34. This extension serves to move the mastoid anchor 9 within its housing portion 8 to place it against or near the papillary muscle 26 because the wire/rod moves with the housing 8 along with the mastoid anchor 8 within the distal housing portion 8 as the junction 34 extends. This may be due to friction between the mastoid anchor 9 (or mastoid anchor push tube) and the inner surface of the housing portion's distal portion 8. This position may be confirmed by 3D ultrasound and/or other available sources.
当远端部分8的远端部与身体组织接触时，随着进一步施加力，来自身体组织的反作用力最终超过将乳突锚9保持在适当位置的力，此时，组织被推平在远端部分8的基部下方，从而使得乳突锚9的所有销62能够最大可能地被正确地置入组织中，并且可以对乳突锚9施加力，使得销62的端部移动超过远端部分8的远端部以与身体组织接触。这可以通过来自杆或丝线60的施加在乳突锚9上的额外的力或延伸调节导管21来实现，或者可以通过对乳突锚9施加预拉力(或调节导管21和远端部分8之间的摩擦)来实现，该预拉力通过与远端部分的摩擦保持，直到来自身体组织在远端部分8上的力充分改变力与摩擦力的平衡，使得乳突锚9以类似于纸钉书机的方式弹出。当乳突锚9被弹出时，销62向外折叠并形成为不受约束的乳突锚9的钩形，从而与身体组织26接合。此时，操作人员可以对连接进行拉动测试，和/或通过X射线和/或超声波进行目视确认。如果连接不令人满意，可以将乳突锚9拉回到远端部分8并重新放置，以尝试改善锚9与身体组织26的联接。When the distal end of the distal portion 8 contacts the body tissue, as further force is applied, the reaction force from the body tissue eventually exceeds the force holding the mastoid anchor 9 in place, at which point the tissue is pushed flat below the base of the distal portion 8, thereby enabling all of the pins 62 of the mastoid anchor 9 to be properly placed in the tissue to the greatest extent possible, and force can be applied to the mastoid anchor 9 so that the ends of the pins 62 move beyond the distal end of the distal portion 8 to contact the body tissue. This can be achieved by additional force from the rod or wire 60 applied to the mastoid anchor 9 or extending the adjustment catheter 21, or by applying a pre-tension to the mastoid anchor 9 (or friction between the adjustment catheter 21 and the distal portion 8), which is maintained by friction with the distal portion until the force from the body tissue on the distal portion 8 sufficiently changes the balance of force and friction so that the mastoid anchor 9 pops out in a manner similar to a paper stapler. When the mastoid anchor 9 is popped out, the pins 62 fold outward and form into the hook shape of the unconstrained mastoid anchor 9, thereby engaging the body tissue 26. At this point, the operator can pull test the connection and/or visually confirm it via X-ray and/or ultrasound. If the connection is not satisfactory, the mastoid anchor 9 can be pulled back to the distal portion 8 and repositioned to try to improve the connection between the anchor 9 and the body tissue 26.
图15示出了可能的后续步骤。收回装置的主要部分4、8，以最小化对移动的瓣叶12的影响。调节导管21可保留在乳突锚9处。人造腱索线14的长度可以用来自外部的丝线进行调节。继续调节长度，并监测瓣叶12的功能。通过将索丝线通过导管回拉，可以减小人造腱索线14的长度。还可以通过推动索丝线来增加长度，这将松弛人造腱索线14，并允许瓣叶12移动以将其拉出调节导管21。调节导管21的尺寸小意味着装置对瓣叶12功能的影响最小化。使用3D超声和/或其他可用源确认人造腱索线14的适当长度。Figure 15 shows possible subsequent steps. The main parts 4, 8 of the device are retracted to minimize the impact on the moving leaflets 12. The adjustment catheter 21 can remain at the mastoid anchor 9. The length of the artificial chords 14 can be adjusted with a silk thread from the outside. Continue to adjust the length and monitor the function of the leaflets 12. The length of the artificial chords 14 can be reduced by pulling the silk threads back through the catheter. The length can also be increased by pushing the silk threads, which will relax the artificial chords 14 and allow the leaflets 12 to move to pull them out of the adjustment catheter 21. The small size of the adjustment catheter 21 means that the device has minimal impact on the function of the leaflets 12. Confirm the appropriate length of the artificial chords 14 using 3D ultrasound and/or other available sources.
当确认长度适当后，装置便会从乳突锚9脱离接合。此过程还会将人造腱索线14锁定在适当位置，并切断任何多余部分，这些多余部分会保留在导管中，并在移除导管时从体内取出。乳突锚9的锁定部段28通过切割件(未示出)保持打开。锁定部段28是乳突锚9的可以弯曲以打开一间隙用于人造腱索线14通过的一段。在乳突锚9的自然形状下，当未施加力时，此锁定部段28与锚9的其余部分紧密配合，因此它将人造腱索线14保持就位。锁定部段28被保持打开，直到人造腱索线14达到恰当的长度。切割件切割人造腱索线14，人造腱索线14在调节过程完成时被拉靠刀片。Once the proper length is confirmed, the device is disengaged from the mastoid anchor 9. This process also locks the artificial chord 14 in place and cuts off any excess, which will remain in the catheter and be removed from the body when the catheter is removed. The locking section 28 of the mastoid anchor 9 is held open by a cutting piece (not shown). The locking section 28 is a section of the mastoid anchor 9 that can be bent to open a gap for the artificial chord 14 to pass through. In the natural shape of the mastoid anchor 9, when no force is applied, this locking section 28 fits tightly with the rest of the anchor 9, so it holds the artificial chord 14 in place. The locking section 28 is held open until the artificial chord 14 reaches the proper length. The cutting piece cuts the artificial chord 14, which is pulled against the blade when the adjustment process is complete.
图16至图19包括乳突锚9的更多细节，其包括由弯曲的销62形成的钩62。图8和图9示出了钩62的一种可能形式，其具有中心狭缝64和一系列孔66，孔66上穿有缝合线68。如上所述，该缝合线68和孔66可使钩62在愈合期间更好地与身体组织接合，并且在发生断裂时保持钩62的材料与乳突锚9的主体连接。图16示出了钩62的折起/受约束形状，其也是在制造锚9期间、在热定形以形成曲形轮廓之前在管状部分中形成的尖齿的形状。图17示出了钩62的弯曲形式，即展开/不受约束的形式。FIGS. 16-19 include further details of the mastoid anchor 9, which includes a hook 62 formed from a bent pin 62. FIGS. 8 and 9 show one possible form of the hook 62, which has a central slit 64 and a series of holes 66 through which sutures 68 are threaded. As described above, the sutures 68 and holes 66 allow the hook 62 to better engage with body tissue during healing and to keep the material of the hook 62 connected to the body of the mastoid anchor 9 in the event of a break. FIG. 16 shows the folded/constrained shape of the hook 62, which is also the shape of the tines formed in the tubular portion during manufacture of the anchor 9, prior to heat setting to form the curved profile. FIG. 17 shows the hook 62 in a curved form, i.e., an unfolded/unconstrained form.
图18和图19示出了完整的乳突锚9的示例，再次示出了折起(图18)和展开(图19)构型。该乳突锚9包括具有狭缝64形式的开口的钩62，这可以在愈合期间导致与身体更好地接合以及增加表面积而不损失灵活性。Figures 18 and 19 show an example of a complete mastoid anchor 9, again showing a folded (Figure 18) and unfolded (Figure 19) configuration. The mastoid anchor 9 includes a hook 62 with an opening in the form of a slit 64, which can result in better engagement with the body and increased surface area without loss of flexibility during healing.
WO2016/042022和WO2020/109596中公开的导管装置2从瓣叶12的心室侧植入瓣叶锚10。如图15所示，因此，人造腱索线14从瓣叶12的心室表面从瓣叶下降到乳头肌26。如WO2016/042022和WO2020/109596中所述，在瓣叶12的心室侧植入瓣叶锚10或下文讨论的软组织锚固系统以及人造腱索线14具有许多益处。The catheter device 2 disclosed in WO2016/042022 and WO2020/109596 implants the leaflet anchor 10 from the ventricular side of the leaflet 12. As shown in Figure 15, the artificial chord 14 thus descends from the leaflet to the papillary muscle 26 from the ventricular surface of the leaflet 12. As described in WO2016/042022 and WO2020/109596, implanting the leaflet anchor 10 or the soft tissue anchoring system discussed below and the artificial chord 14 on the ventricular side of the leaflet 12 has many benefits.
然而，在某些情况下，从瓣叶12的心房侧植入瓣叶锚110或下文讨论的软组织锚固系统，从而植入人造腱索线114是有利的。例如，如在图15中可以看出，人造腱索线14下降至乳头肌26，未给瓣叶12的边缘13提供任何额外的支撑。当从瓣叶12的心室侧植入时，人造腱索线14不向瓣叶12的边缘13提供额外的支撑。因此，植入的人造腱索线14可能无法如期望那样精确地复制朝向瓣叶12的边缘13定位的腱索的动作。However, in certain circumstances, it may be advantageous to implant the leaflet anchor 110, or a soft tissue anchoring system discussed below, and thereby the artificial chords 114, from the atrial side of the leaflet 12. For example, as can be seen in FIG. 15 , the artificial chords 14 descend to the papillary muscles 26 without providing any additional support to the edges 13 of the leaflets 12. When implanted from the ventricular side of the leaflets 12, the artificial chords 14 do not provide additional support to the edges 13 of the leaflets 12. As a result, the implanted artificial chords 14 may not replicate the action of chordae positioned toward the edges 13 of the leaflets 12 as accurately as desired.
从瓣叶12的心室侧植入瓣叶锚10或下文讨论的软组织锚固系统还需要更精确地放置瓣叶锚10。由于没有为瓣叶12的边缘13提供额外的支撑，因此瓣叶锚10的放置将决定瓣叶12的边缘13由瓣叶锚12支撑和/或固定的程度。相比之下，从瓣叶12的心房侧植入瓣叶锚110或下文讨论的软组织锚固系统的放置可以不那么精确，因为人造腱索线114将在从心脏的心房进入心室时为瓣叶12的边缘13提供额外的支撑。Implanting the leaflet anchor 10, or the soft tissue anchoring system discussed below, from the ventricular side of the leaflet 12 also requires more precise placement of the leaflet anchor 10. Because no additional support is provided to the edge 13 of the leaflet 12, the placement of the leaflet anchor 10 will determine the degree to which the edge 13 of the leaflet 12 is supported and/or secured by the leaflet anchor 12. In contrast, implanting the leaflet anchor 110, or the soft tissue anchoring system discussed below, from the atrial side of the leaflet 12 may be less precisely placed because the artificial chords 114 will provide additional support to the edge 13 of the leaflet 12 as it passes from the atrium of the heart into the ventricle.
图20示出了在利用乳突锚109将人造腱索线114植入乳头肌26中，以及利用瓣叶锚110或下文讨论的软组织锚固系统将人造腱索线114植入心脏的瓣叶12之后，导引导管122和导管装置102的远端部分108的撤回。调节导管121被示出为在其撤回之前处于适当位置。在图示配置中，可以根据需要调整人造腱索线114的长度。FIG. 20 shows the withdrawal of the distal end portion 108 of the guide catheter 122 and the catheter device 102 after the artificial chord 114 is implanted in the papillary muscle 26 using the mastoid anchor 109 and the artificial chord 114 is implanted in the heart's valve leaflet 12 using the leaflet anchor 110 or the soft tissue anchoring system discussed below. The adjustment catheter 121 is shown in position before its withdrawal. In the illustrated configuration, the length of the artificial chord 114 can be adjusted as needed.
图20与图15所示的布置类似，但示出了从瓣叶12的心房侧而不是心室侧植入的瓣叶锚110。如图2所示，人造腱索线114从瓣叶锚110的基部延伸，其在此处朝向瓣叶的边缘13附接。由于人造腱索线114在拉力下或其他情况下将采取最短的可能的路径到达其另一端被植入的乳头肌26，因此人造腱索线114将与瓣叶12的心房侧表面接触，并将以接触的方式在瓣叶12的边缘13上下降。因此，植入瓣叶12的心房侧的人造腱索线114将为瓣叶12的边缘13提供额外的支撑。FIG20 is similar to the arrangement shown in FIG15 , but shows the leaflet anchor 110 implanted from the atrial side rather than the ventricular side of the leaflet 12. As shown in FIG2 , the artificial chord 114 extends from the base of the leaflet anchor 110, where it is attached toward the edge 13 of the leaflet. Since the artificial chord 114 will take the shortest possible path to the papillary muscle 26 where its other end is implanted under tension or otherwise, the artificial chord 114 will contact the atrial side surface of the leaflet 12 and will descend in a contacting manner over the edge 13 of the leaflet 12. Thus, the artificial chord 114 implanted on the atrial side of the leaflet 12 will provide additional support to the edge 13 of the leaflet 12.
人造腱索线114可包含沿其长度变化的横截面积区域。通过增加人造腱索线114在某些部分的横截面积，人造腱索线114可以具有与心脏的瓣叶12的增加的接触面积。这样，人造腱索线114施加到瓣叶12上的力可更均匀地分布，并且可以避免人造腱索线114可能导致的对瓣叶12的任何挤夹。The artificial chord 114 may include a cross-sectional area that varies along its length. By increasing the cross-sectional area of the artificial chord 114 at certain portions, the artificial chord 114 may have an increased contact area with the heart's leaflets 12. In this way, the forces applied by the artificial chord 114 to the leaflets 12 may be more evenly distributed, and any pinching of the leaflets 12 that may be caused by the artificial chord 114 may be avoided.
人造腱索线114包括靠近瓣叶12的扁平横截面，即，使得人造腱索线114的横截面积的长轴与瓣叶12的表面平行。在替代布置中，人造腱索线114可以由多个缝合线形成，使得人造腱索线114与瓣叶12的心房表面之间的接触面积增加。The artificial chords 114 include a flat cross-section near the leaflets 12, i.e., such that the major axis of the cross-sectional area of the artificial chords 114 is parallel to the surface of the leaflets 12. In an alternative arrangement, the artificial chords 114 may be formed from a plurality of sutures such that the contact area between the artificial chords 114 and the atrial surface of the leaflets 12 is increased.
为了将瓣叶锚110从心房侧植入心脏的瓣叶12中，导管装置102的夹持壳体106和瓣叶锚部署机构被布置成如图21或图22所示。In order to implant the leaflet anchor 110 into the leaflet 12 of the heart from the atrial side, the clamp housing 106 and the leaflet anchor deployment mechanism of the catheter device 102 are arranged as shown in FIG. 21 or FIG. 22 .
图21示出了导管装置102，其包括夹持壳体106、夹持臂130和人造腱索线114，人造腱索线114附接至瓣叶锚110或下文讨论的软组织锚固系统并延伸过导管装置102的主体。在这些图的示例中，瓣叶锚110容纳在导管装置102的主体中，并通过将其推出位于导管装置102的主体中的瓣叶锚管138而被部署。瓣叶锚管138的功能类似于上述的瓣叶锚管38。瓣叶锚管138位于导管装置102的主体中，使得当瓣叶12被抓握在夹持臂130和导管装置102的主体之间时(类似于图7所示)，瓣叶锚110可以从锚管138部署到瓣叶12的心房侧。因此，瓣叶锚110将部署在瓣叶12中，如图20所示。通过使用下面讨论的软组织锚固系统，导管装置102可以适于用替代的锚部署机构(例如用于在织物体的臂部被植入瓣叶时保持和引导它们的不同设计的管)来替换这些图中的瓣叶锚管138。FIG. 21 shows a catheter device 102 including a clamp housing 106, a clamp arm 130, and an artificial chord line 114, which is attached to a leaflet anchor 110 or a soft tissue anchoring system discussed below and extends through the body of the catheter device 102. In the example of these figures, the leaflet anchor 110 is housed in the body of the catheter device 102 and is deployed by pushing it out of a leaflet anchor tube 138 located in the body of the catheter device 102. The function of the leaflet anchor tube 138 is similar to the leaflet anchor tube 38 described above. The leaflet anchor tube 138 is located in the body of the catheter device 102 so that when the leaflet 12 is grasped between the clamp arm 130 and the body of the catheter device 102 (similar to that shown in FIG. 7), the leaflet anchor 110 can be deployed from the anchor tube 138 to the atrial side of the leaflet 12. Thus, the leaflet anchor 110 will be deployed in the leaflet 12, as shown in FIG. 20. By using the soft tissue anchoring system discussed below, the catheter device 102 can be adapted to replace the leaflet anchor tubes 138 of these figures with alternative anchor deployment mechanisms, such as tubes of different designs for holding and guiding the arms of the fabric body as they are implanted into the leaflets.
图22示出了导管装置102的替代布置，其包括夹持壳体106、夹持臂130和附接到瓣叶锚110的人造腱索线114。虽然未示出，但是人造腱索线将被穿行通过夹持臂130和导管装置102的主体，使得一旦在植入后调整线114，人造腱索线114就可以从导管装置102中展开。瓣叶锚110容纳在位于夹持臂130中的瓣叶锚管110中，瓣叶锚管138的开口位于夹持臂130的远端部。为了使瓣叶锚110能够如图20所示部署在瓣叶12的心房侧，夹持臂130从导管装置102的近端部旋转，使得瓣叶锚管138的开口将位于瓣叶12的心房侧表面附近。这也可以适用于下面讨论的软组织锚固系统的部署布置。FIG. 22 shows an alternative arrangement of the catheter device 102, which includes the clamp housing 106, the clamp arm 130, and the synthetic chord wire 114 attached to the leaflet anchor 110. Although not shown, the synthetic chord wire will be threaded through the clamp arm 130 and the body of the catheter device 102 so that once the wire 114 is adjusted after implantation, the synthetic chord wire 114 can be deployed from the catheter device 102. The leaflet anchor 110 is housed in the leaflet anchor tube 110 located in the clamp arm 130, and the opening of the leaflet anchor tube 138 is located at the distal end of the clamp arm 130. In order to enable the leaflet anchor 110 to be deployed on the atrial side of the leaflet 12 as shown in FIG. 20, the clamp arm 130 is rotated from the proximal end of the catheter device 102 so that the opening of the leaflet anchor tube 138 will be located near the atrial side surface of the leaflet 12. This can also be applied to the deployment arrangement of the soft tissue anchor system discussed below.
在图21和图22所示的两种布置中，导管装置102的部件的功能可类似于关于图1至图19所描述的部件的功能。瓣叶锚管138的操作通常类似于关于图6至图12所讨论的瓣叶锚管38。夹持装置106的功能类似于关于图2至图6所讨论的夹持装置6的功能。乳突锚109类似于上述的瓣叶锚9。In both arrangements shown in Figures 21 and 22, the functions of the components of the catheter device 102 may be similar to the functions of the components described with respect to Figures 1 to 19. The operation of the leaflet anchor tube 138 is generally similar to the leaflet anchor tube 38 discussed with respect to Figures 6 to 12. The function of the clamp device 106 is similar to the function of the clamp device 6 discussed with respect to Figures 2 to 6. The mastoid anchor 109 is similar to the leaflet anchor 9 described above.
在图21和图22所示的两种布置中，并且如上所述，瓣叶锚管138沿导管装置102的主体或夹持臂130的方向延伸，使得瓣叶锚管138的开口朝向导管装置102的远端部打开。当导管装置102从瓣叶12和乳头肌上方(即如上所述的从左心房)接近瓣叶12和乳头肌26时，瓣叶锚管138的开口因此布置为与瓣叶12的心房表面相遇，使得瓣叶锚110可以植入瓣叶12的心房表面中。21 and 22 , and as described above, the leaflet anchor tube 138 extends in the direction of the body or clamp arm 130 of the catheter device 102, such that the opening of the leaflet anchor tube 138 opens toward the distal end of the catheter device 102. When the catheter device 102 approaches the leaflets 12 and papillary muscles 26 from above the leaflets 12 and papillary muscles (i.e., from the left atrium as described above), the opening of the leaflet anchor tube 138 is thus arranged to meet the atrial surface of the leaflets 12, so that the leaflet anchor 110 can be implanted in the atrial surface of the leaflets 12.
WO2016/042022和WO2020/109596中教导的导管装置使用U形杆来部署瓣叶锚。然而，导管装置102采用线性杆来部署瓣叶锚110。这种布置也可以用于部署下文讨论的软组织锚固系统。线性杆将从导管装置102的近端部延伸到瓣叶锚管138中，使得瓣叶锚110或下文讨论的软组织锚固系统可以部署到瓣叶12的心房侧。线性杆可以通过使用线性杆的位于瓣叶锚管138中的端部将锚固系统推出瓣叶锚管138的面向远端的开口来部署锚固系统。线性杆是柔性的，使得它可以弯曲或弯折，例如，当弯曲时，从图22中所示的导管装置102的主体弯曲到夹持臂130中，并且是可拉伸的，使得它可以被推入瓣叶锚管138和从瓣叶锚管138收回而不会变长。当瓣叶锚管138位于夹持臂130中时(如图22所示)，线性杆的弹性特性可以帮助将夹持臂130恢复到闭合位置，即与导管装置的主体齐平。线性杆由具有高弹性变形能力的材料制成，以便允许可弯曲部分的弯曲。合适的材料包括形状记忆材料，例如形状记忆金属，如镍钛合金。使用形状记忆金属还意味着线性杆可以变得坚硬，这使得通过线性杆的力传递更有效率。或者，线性杆可以由几种类型的材料制成，以实现所需的特性。The catheter devices taught in WO2016/042022 and WO2020/109596 use a U-shaped rod to deploy the leaflet anchor. However, the catheter device 102 uses a linear rod to deploy the leaflet anchor 110. This arrangement can also be used to deploy the soft tissue anchor system discussed below. The linear rod will extend from the proximal end of the catheter device 102 into the leaflet anchor tube 138 so that the leaflet anchor 110 or the soft tissue anchor system discussed below can be deployed to the atrial side of the leaflet 12. The linear rod can deploy the anchor system by using the end of the linear rod located in the leaflet anchor tube 138 to push the anchor system out of the distal-facing opening of the leaflet anchor tube 138. The linear rod is flexible so that it can bend or bend, for example, when bent, from the body of the catheter device 102 shown in Figure 22 to the clamping arm 130, and is stretchable so that it can be pushed into the leaflet anchor tube 138 and retracted from the leaflet anchor tube 138 without becoming longer. When the leaflet anchor tube 138 is located in the clamp arm 130 (as shown in Figure 22), the elastic properties of the linear rod can help restore the clamp arm 130 to a closed position, i.e., flush with the body of the catheter device. The linear rod is made of a material with a high elastic deformation ability to allow bending of the bendable portion. Suitable materials include shape memory materials, such as shape memory metals, such as nickel titanium alloy. The use of shape memory metals also means that the linear rod can be made rigid, which makes the force transmission through the linear rod more efficient. Alternatively, the linear rod can be made of several types of materials to achieve the desired properties.
虽然将结合如关于图20至图22讨论的导管装置102来讨论以下特征，但应当理解，以下特征类似地与结合图1至图19讨论的以及在WO2016/042022和WO2020/109596中公开的导管装置2兼容。Although the following features will be discussed in conjunction with the catheter device 102 as discussed with respect to Figures 20 to 22, it should be understood that the following features are similarly compatible with the catheter device 2 discussed in conjunction with Figures 1 to 19 and disclosed in WO2016/042022 and WO2020/109596.
图23和图24示出了替代布置的夹持装置106。夹持装置106包括夹持臂130和夹持杆132。夹持杆132被偏置，使得在静止状态，即在未部署构型中，夹持杆将与导管装置102的主壳体齐平，如图41所示。夹持杆132位于夹持臂130和导管装置102的主体之间，使得如果不先打开夹持臂130，夹持杆132就不能被致动离开导管装置102的主体(如图24所示)。23 and 24 show an alternative arrangement of the clamping device 106. The clamping device 106 includes a clamping arm 130 and a clamping rod 132. The clamping rod 132 is biased so that in a rest state, i.e., in an undeployed configuration, the clamping rod will be flush with the main housing of the catheter device 102, as shown in FIG41. The clamping rod 132 is located between the clamping arm 130 and the body of the catheter device 102 so that the clamping rod 132 cannot be actuated away from the body of the catheter device 102 without first opening the clamping arm 130 (as shown in FIG24).
夹持杆132固定在夹持臂130进行旋转的位置附近的一端。夹持杆132的另一端可相对于导管装置102的主体自由移动。夹持杆132的自由端附接到丝线或杆134，丝线或杆134穿过导管装置102的主体并推动夹持杆132的自由端。因此，当被推动时，杆134会致动夹持杆132，使其处于展开构型。在展开构型中，夹持杆132的自由端布置成与夹持臂130接触。因此，在使用时，瓣叶12可被抓握在夹持臂130和夹持杆132之间。The clamping rod 132 is fixed at one end near the position where the clamping arm 130 rotates. The other end of the clamping rod 132 can move freely relative to the body of the catheter device 102. The free end of the clamping rod 132 is attached to a wire or rod 134, which passes through the body of the catheter device 102 and pushes the free end of the clamping rod 132. Therefore, when pushed, the rod 134 actuates the clamping rod 132 to put it in the expanded configuration. In the expanded configuration, the free end of the clamping rod 132 is arranged to contact the clamping arm 130. Therefore, when in use, the leaflet 12 can be grasped between the clamping arm 130 and the clamping rod 132.
夹持臂130和夹持杆132的组合抓握动作可帮助确保正确地抓握瓣叶12。夹持臂130可被打开，使得夹持臂130的夹持表面136与瓣叶12接触。没有额外的支撑，由于瓣叶12在心动周期期间的运动，瓣叶12可能会在夹持臂130闭合时移动离开夹持臂130。然而，夹持装置106的当前布置在夹持臂130闭合之前展开夹持杆132。因此，瓣叶12在夹持臂130闭合之前被固定在夹持杆132和夹持臂130之间。最后，可以收回夹持杆132和夹持臂130，而瓣叶12仍然被固定，使得当夹持臂130处于闭合位置时，瓣叶12被固定在夹持臂130和导管装置102的主体之间的所需位置。然后，瓣叶锚110可以被部署在所需位置。因此，夹持杆132的设置可以帮助增加成功地抓握瓣叶12的可能性，并且可以确保瓣叶锚110或下文进一步讨论的软组织锚固系统在瓣叶12中的正确定位。The combined grasping action of the clamp arms 130 and clamp rods 132 can help ensure that the leaflets 12 are properly grasped. The clamp arms 130 can be opened so that the clamping surfaces 136 of the clamp arms 130 are in contact with the leaflets 12. Without additional support, the leaflets 12 may move away from the clamp arms 130 as the clamp arms 130 close due to movement of the leaflets 12 during the cardiac cycle. However, the current arrangement of the clamp device 106 deploys the clamp rods 132 before the clamp arms 130 close. Therefore, the leaflets 12 are secured between the clamp rods 132 and the clamp arms 130 before the clamp arms 130 close. Finally, the clamp rods 132 and clamp arms 130 can be retracted while the leaflets 12 are still secured so that when the clamp arms 130 are in the closed position, the leaflets 12 are secured in a desired position between the clamp arms 130 and the body of the catheter device 102. The leaflet anchors 110 can then be deployed in the desired position. Thus, provision of the clamping rod 132 may help increase the likelihood of successfully grasping the leaflet 12 and may ensure proper positioning of the leaflet anchor 110 or a soft tissue anchoring system discussed further below within the leaflet 12 .
夹持杆132可以包括沿着其长度的多个凹口或齿，这可以有助于抓握瓣叶12。凹口或齿增加了夹持杆132的摩擦保持力，使得瓣叶12在被抓握时不太可能意外地从夹持臂130和夹持杆132松开。夹持杆132通常是柔性的，使得可将其保持在夹持臂130进行旋转的位置处的端部处，并可由杆134推动其自由端以与夹持臂130接触。夹持杆132和杆134可各自由合适的弹性但可拉伸的材料(例如，镍钛合金或不锈钢)制成。可以通过将部件粘合或焊接在一起来将夹持杆132固定到导管装置102的主体和杆134上。The clamping rod 132 may include a plurality of notches or teeth along its length, which may assist in grasping the leaflet 12. The notches or teeth increase the frictional retention of the clamping rod 132, making it less likely that the leaflet 12 will accidentally loosen from the clamping arm 130 and the clamping rod 132 when being grasped. The clamping rod 132 is generally flexible so that it can be held at its end at a position where the clamping arm 130 is rotated and its free end can be pushed by the rod 134 to contact the clamping arm 130. The clamping rod 132 and the rod 134 may each be made of a suitable elastic but stretchable material (e.g., a nickel titanium alloy or stainless steel). The clamping rod 132 may be secured to the body of the catheter device 102 and the rod 134 by gluing or welding the parts together.
尽管本文描述了夹持杆132在不受约束时与导管装置102的主体齐平，并且在杆134被致动时接触夹持表面136，但是夹持杆132也可以替换地在不受约束时与夹持臂130的夹持表面136齐平。因此，当杆134拉动夹持杆132的自由端时，夹持杆132将被张开而远离夹持臂130。然后，可以在张开的夹持杆132和张开的夹持臂130之间抓握瓣叶12。因此，释放杆134将导致夹持杆132返回到其不受约束的位置，从而将瓣叶12抓握在其自身和夹持臂130之间。夹持杆132被偏压以在没有施加力时抓握瓣叶12，这可以更牢固且/或可靠地握住瓣叶12。Although the clamping rods 132 are described herein as being flush with the body of the catheter device 102 when unconstrained and contacting the clamping surface 136 when the rods 134 are actuated, the clamping rods 132 may alternatively be flush with the clamping surface 136 of the clamping arms 130 when unconstrained. Thus, when the rods 134 pull the free ends of the clamping rods 132, the clamping rods 132 will be opened away from the clamping arms 130. The leaflets 12 may then be grasped between the opened clamping rods 132 and the opened clamping arms 130. Thus, releasing the rods 134 will cause the clamping rods 132 to return to their unconstrained position, thereby grasping the leaflets 12 between themselves and the clamping arms 130. The clamping rods 132 are biased to grasp the leaflets 12 when no force is applied, which may more securely and/or reliably grasp the leaflets 12.
如上文简要所述，本发明的实施例涉及如本文现在描述的软组织锚固系统。本文描述的软组织锚固系统可用于上文结合图1至图24描述的类型的导管装置2，为此，这些图中所示的瓣叶锚10、110可由下文所述并结合其余图讨论的软组织锚固系统代替，本领域技术人员可以理解其他修改。As briefly described above, embodiments of the present invention relate to soft tissue anchoring systems as now described herein. The soft tissue anchoring systems described herein may be used with catheter devices 2 of the type described above in conjunction with FIGS. 1 to 24, for which the leaflet anchors 10, 110 shown in these figures may be replaced by the soft tissue anchoring systems described below and discussed in conjunction with the remaining figures, and other modifications may be understood by those skilled in the art.
其余图中所示或与之相关地讨论的软组织锚固系统用于植入身体软组织中，更具体地说，可以用作瓣叶锚固系统，用于二尖瓣瓣叶的外科修复，瓣叶锚固系统用于在修复过程中将人造线附接到心脏的瓣叶。这种修复类型在WO2016/042022和WO2020/109588中均有讨论，并且如上文关于图1至图24所述。The soft tissue anchoring systems shown in or discussed in connection with the remaining figures are for implantation in soft tissue of the body and, more particularly, can be used as leaflet anchoring systems for surgical repair of mitral valve leaflets, the leaflet anchoring systems being used to attach artificial threads to the leaflets of the heart during the repair procedure. This type of repair is discussed in both WO2016/042022 and WO2020/109588 and as described above with respect to FIGS. 1 to 24 .
然而，与WO2016/042022和WO2020/109588中公开的概念相反，在一些实施例中，本锚固系统采用织物型布置，其中，U形织物体的两个臂穿过身体组织，然后以手风琴状的方式折叠以将身体组织夹在U形织物体的基部和U形织物体的每个臂部之间。However, contrary to the concepts disclosed in WO2016/042022 and WO2020/109588, in some embodiments, the present anchoring system adopts a fabric-type arrangement, wherein the two arms of the U-shaped fabric body pass through the body tissue and then are folded in an accordion-like manner to clamp the body tissue between the base of the U-shaped fabric body and each arm of the U-shaped fabric body.
图25示出了根据本发明的包括U形织物体201的软组织锚固系统200。U形织物体201包括基部202和从基部202延伸的两个臂部204。窄腰部203在基部202和每个相应的臂部204之间延伸。包括由单个基部202连接的多个臂部204的软组织锚固系统200可在与身体组织接合时在身体组织的两侧增加锚固系统200的表面积。这可提高锚固系统200在植入身体组织时的稳定性。FIG. 25 shows a soft tissue anchoring system 200 including a U-shaped fabric body 201 according to the present invention. The U-shaped fabric body 201 includes a base 202 and two arms 204 extending from the base 202. A narrow waist 203 extends between the base 202 and each corresponding arm 204. The soft tissue anchoring system 200 including multiple arms 204 connected by a single base 202 can increase the surface area of the anchoring system 200 on both sides of the body tissue when engaged with the body tissue. This can improve the stability of the anchoring system 200 when implanted in the body tissue.
U形织物体201用于将朝向基部202定位的人造腱索线214锚固到身体组织。作为织物体，可以理解的是，U形织物体201主要由软质材料形成。U形织物体201的功能可与棉纱相媲美。在一些实施例中，并且如图25所示，基部202包括嵌入其中的形状保持特征205，例如镍钛合金丝框架等。形状保持特征205可帮助基部202随时间保持其形状和/或在植入时为身体组织提供额外的侧向支撑。臂部204还可以可选地设有加强元件206。The U-shaped fabric body 201 is used to anchor the artificial tendon line 214 positioned toward the base 202 to the body tissue. As a fabric body, it is understandable that the U-shaped fabric body 201 is mainly formed by soft materials. The function of the U-shaped fabric body 201 is comparable to cotton yarn. In certain embodiments, and as shown in Figure 25, the base 202 includes a shape-retaining feature 205 embedded therein, such as a nickel-titanium alloy wire frame, etc. The shape-retaining feature 205 can help the base 202 to maintain its shape over time and/or provide additional lateral support for body tissue when implanted. The arm 204 can also be optionally provided with a reinforcing element 206.
U形织物体201还包括拉伸线214'。每个臂部204包括拉伸线214'的穿线通过臂部204和基部202的部分，该穿线从臂部204的远离基部202的一端延伸到基部102。拉伸线214’的每个部分都朝向臂部204的远端部固定，但可以相对于沿臂部204和在基部202中形成的穿线孔207自由移动。The U-shaped fabric body 201 also includes a tensile wire 214'. Each arm 204 includes a portion of the tensile wire 214' threaded through the arm 204 and the base 202, and the threading extends from the end of the arm 204 away from the base 202 to the base 102. Each portion of the tensile wire 214' is fixed toward the distal end of the arm 204, but can move freely relative to the threading hole 207 formed along the arm 204 and in the base 202.
每个臂部204被配置成通过穿线通过臂部204的拉伸线214'的作用而以折叠方式朝向基部202塌缩。也就是说，当拉力施加到拉伸线214'时，拉伸线214'可以使臂部204以折叠方式朝向基部202塌缩。换句话说，穿线通过臂部204的拉伸线214'是用于使每个臂部204以折叠方式向基部202塌缩而使得在使用中身体组织被夹在基部202和每个臂部204之间的装置的示例。由于U形织物体201主要由柔软材料形成，因此从远离线214'的部分被固定到臂部204的位置的端部致动拉伸线214'会导致臂部204以手风琴方式塌缩(即向基部202折叠而塌缩)。Each arm 204 is configured to collapse toward the base 202 in a folding manner by the action of a stretch wire 214' threaded through the arm 204. That is, when a tensile force is applied to the stretch wire 214', the stretch wire 214' can cause the arm 204 to collapse toward the base 202 in a folding manner. In other words, the stretch wire 214' threaded through the arm 204 is an example of a means for causing each arm 204 to collapse toward the base 202 in a folding manner so that body tissue is sandwiched between the base 202 and each arm 204 in use. Since the U-shaped fabric body 201 is mainly formed of a soft material, actuating the stretch wire 214' from the end of the position where the portion away from the wire 214' is fixed to the arm 204 causes the arm 204 to collapse in an accordion manner (i.e., collapse by folding toward the base 202).
位于臂部204的远离基部202的端部处的还有端盖208。端盖208是刚性结构，其有助于将U形织物体201植入身体组织中，并且还有助于维持U形织物体201与身体组织的接合。Also located at the end of the arm 204 away from the base 202 is an end cap 208. The end cap 208 is a rigid structure that helps implant the U-shaped fabric body 201 into body tissue and also helps maintain engagement of the U-shaped fabric body 201 with the body tissue.
图26以较近的视角示出了图25的细节A'。穿线通过臂部204的线214'的部分通过端盖208固定到臂部214'的远端部。在图25和图26所示的实施例中，拉伸线214'的每个相应端部由每个相应的端盖208的开口211接收并固定在其中。每个端盖208还包括用于接收丝线引导构件218的开口210，如下文进一步详细讨论的。使用接收丝线引导构件218以植入锚固系统200的端盖208可以方便植入，因为织物体201不需要从空心针内植入。因此，对植入部位的创伤将减少，因为可以使用较窄的穿刺构件来部署软组织锚固系统200。Figure 26 shows the detail A' of Figure 25 with a closer perspective. The part of the line 214' threaded through the arm 204 is fixed to the distal end of the arm 214' by the end cap 208. In the embodiment shown in Figures 25 and 26, each corresponding end of the stretch line 214' is received and fixed therein by the opening 211 of each corresponding end cap 208. Each end cap 208 also includes an opening 210 for receiving a wire guide member 218, as discussed in further detail below. Using the end cap 208 that receives the wire guide member 218 to implant the anchoring system 200 can facilitate implantation, because the fabric body 201 does not need to be implanted from the hollow needle. Therefore, the trauma to the implantation site will be reduced, because the soft tissue anchoring system 200 can be deployed using a narrower puncture member.
图27A、图27B和图27C示出了植入心脏的二尖瓣瓣叶12中的软组织锚固系统200。基部202被布置成接触瓣叶12的心房表面12a，而手风琴式臂部204(如图27B和图27C所示)布置成接触瓣叶12的心室表面12b。因此，在使用中，瓣叶12夹在基部202和臂部204之间。27A, 27B and 27C show a soft tissue anchoring system 200 implanted in a mitral valve leaflet 12 of a heart. The base 202 is arranged to contact the atrial surface 12a of the leaflet 12, while the accordion-type arm 204 (as shown in FIGS. 27B and 27C) is arranged to contact the ventricular surface 12b of the leaflet 12. Thus, in use, the leaflet 12 is sandwiched between the base 202 and the arm 204.
如图27B和图27C所示，人造腱索线214为拉伸线214'提供如箭头T所示的拉力，从而将其固定端拉向基部202。这导致臂部204以折叠方式塌缩到手风琴式位置中。27B and 27C, the synthetic chord wire 214 provides tension to the tension wire 214' as indicated by arrow T, thereby pulling its fixed end toward the base 202. This causes the arm 204 to collapse in a folded manner into an accordion-like position.
人造腱索线214可通过任何合适的紧固装置(例如结或孔眼)连接到拉伸线214'。在图27B所示的实施例中，人造线214通过结215连接到拉伸线214'。The synthetic chord wire 214 may be connected to the tensile wire 214' by any suitable fastening means, such as a knot or an eyelet. In the embodiment shown in FIG. 27B , the synthetic wire 214 is connected to the tensile wire 214' by a knot 215 .
现在参考图27A以及图29A和图29B，为了植入U形织物体201，采用了一对丝线引导构件218。丝线引导构件218各自由端盖208的开口210接收。丝线引导构件218用于推动端盖208与瓣叶12形成穿刺接合，并穿过瓣叶12，使得U形织物体201与瓣叶12接合。在这种配置中，端盖208与臂部204共线地延伸。一旦U形织物体201植入瓣叶12中，丝线引导构件218即可收回。丝线引导构件218的收回可导致端盖208返回到与静置的臂部204垂直的取向，或者当臂部204塌缩时(例如，如图27B和图27C中所示)与臂部204的褶层的平面平行的取向。Now referring to FIG. 27A and FIG. 29A and FIG. 29B, in order to implant the U-shaped fabric body 201, a pair of wire guide members 218 are used. The wire guide members 218 are each received by the opening 210 of the free end cap 208. The wire guide member 218 is used to push the end cap 208 to form a puncture engagement with the leaflet 12, and pass through the leaflet 12 so that the U-shaped fabric body 201 engages with the leaflet 12. In this configuration, the end cap 208 extends in line with the arm 204. Once the U-shaped fabric body 201 is implanted in the leaflet 12, the wire guide member 218 can be retracted. The retraction of the wire guide member 218 can cause the end cap 208 to return to an orientation perpendicular to the stationary arm 204, or when the arm 204 collapses (e.g., as shown in FIG. 27B and FIG. 27C) and the orientation parallel to the plane of the fold of the arm 204.
图28更详细地示出了端盖208与丝线引导构件218接合时的情况。端盖208具有末端209，在图25至图28中，末端209为钝的或圆形的末端209。提供钝的或圆形的末端209可降低端盖208在植入瓣叶12后撕裂或磨损瓣叶12的风险。FIG28 shows in more detail the engagement of the end cap 208 with the wire guide member 218. The end cap 208 has a tip 209, which in FIG25 to FIG28 is a blunt or rounded tip 209. Providing a blunt or rounded tip 209 can reduce the risk of the end cap 208 tearing or abrading the leaflet 12 after implantation.
图27A和图28中所示的丝线引导构件218穿过端盖208，并且其本身用于刺穿瓣叶12，同时将端盖208推动穿过瓣叶12。在图27A和图28所示的布置中，丝线引导构件218包括刺穿部分219。刺穿部分219包括远端末端，其被配置成在植入软组织锚固系统200期间刺穿瓣叶12。因此，在图27A和图28所示的布置中，丝线引导构件218可被视为刺穿丝线引导构件218。端盖208的开口210沿端盖208的整个长度可察觉地延伸，以使刺穿丝线引导构件218能够穿过其中。为了帮助操作端盖208，丝线引导构件218包括较厚的控制部分220。肩部221位于较薄的刺穿部分219和较厚的控制部分220之间，并且被配置为与端盖208的互补部分接合。以这种方式，将力传递到端盖208导致臂部204被拉动穿过由丝线引导构件218的相应刺穿部分219创建的植入部位。The wire guide member 218 shown in Figures 27A and 28 passes through the end cap 208, and is itself used to pierce the leaflet 12 while pushing the end cap 208 through the leaflet 12. In the arrangement shown in Figures 27A and 28, the wire guide member 218 includes a piercing portion 219. The piercing portion 219 includes a distal end that is configured to pierce the leaflet 12 during implantation of the soft tissue anchoring system 200. Therefore, in the arrangement shown in Figures 27A and 28, the wire guide member 218 can be regarded as piercing the wire guide member 218. The opening 210 of the end cap 208 extends perceptibly along the entire length of the end cap 208 so that the piercing wire guide member 218 can pass therethrough. In order to help operate the end cap 208, the wire guide member 218 includes a thicker control portion 220. Shoulder 221 is located between thinner piercing portion 219 and thicker control portion 220 and is configured to engage with a complementary portion of end cap 208. In this way, transmitting force to end cap 208 causes arm 204 to be pulled through the implantation site created by corresponding piercing portion 219 of wire guide member 218.
然而，在未示出的其他布置中，丝线引导构件218可以包括用于推动端盖208的第一空心轴，第二穿刺丝线穿过空心轴，用于刺穿组织。这种配置将提供更多的自由度，但也包括更多的部件。However, in other arrangements not shown, the wire guide member 218 may include a first hollow shaft for pushing the end cap 208, and a second puncture wire passes through the hollow shaft for puncturing tissue. This configuration will provide more degrees of freedom, but also includes more components.
如图29A和图29B所示，在一些实施例中，端盖208的远离臂部204的末端209是尖头的，使得端盖208能够刺穿瓣叶12。当端盖208的末端209是尖头的时，丝线引导构件218用于将力传递到端盖208，以刺穿瓣叶12并拉动臂部204穿过由端盖208的尖头末端209在瓣叶12中产生的植入部位。As shown in Figures 29A and 29B, in some embodiments, the tip 209 of the end cap 208 away from the arm portion 204 is pointed so that the end cap 208 can pierce the leaflet 12. When the tip 209 of the end cap 208 is pointed, the wire guide member 218 is used to transmit a force to the end cap 208 to pierce the leaflet 12 and pull the arm portion 204 through the implantation site created in the leaflet 12 by the pointed tip 209 of the end cap 208.
图30至图32示出了具有钝化或圆形末端209的端盖208的各种布置。在每种布置中，端盖208包括外管状构件208a和内管状构件208b。内管状构件208b由外管状构件208a接收，使得内管状构件208b同心地嵌套在外管状构件208a内。外管状构件208a和内管状构件208b各自限定沿它们的长度延伸的开口，使得所得的端盖208可以接收丝线引导构件218，并且在图30至图32所示的每种布置中，使得刺穿部分219可以完全穿过端盖208。内管状构件208b限定用于接收丝线引导构件218的开口210。Figures 30 to 32 show various arrangements of end caps 208 with blunt or rounded ends 209. In each arrangement, end cap 208 includes an outer tubular member 208a and an inner tubular member 208b. The inner tubular member 208b is received by the outer tubular member 208a so that the inner tubular member 208b is concentrically nested in the outer tubular member 208a. The outer tubular member 208a and the inner tubular member 208b each define an opening extending along their length so that the resulting end cap 208 can receive the wire guide member 218, and in each arrangement shown in Figures 30 to 32, the piercing portion 219 can pass through the end cap 208 completely. The inner tubular member 208b defines an opening 210 for receiving the wire guide member 218.
外管状构件208a限定了用于接收拉伸线214’的开口211，以及用于便于将U形织物体201的臂部204连接到端盖208的凹口或凹槽212。凹口212可帮助将臂部204相对于端盖208定位，使得端盖208的开口210不会被端盖208遮挡或阻塞。The outer tubular member 208a defines an opening 211 for receiving a tensile wire 214', and a notch or groove 212 for facilitating connection of the arm 204 of the U-shaped fabric body 201 to the end cap 208. The notch 212 can help position the arm 204 relative to the end cap 208 so that the opening 210 of the end cap 208 is not blocked or obstructed by the end cap 208.
如图30至图32所示，拉伸线214’和臂部204被接收在外管状构件208a和内管状构件208b之间。臂部204沿内管状构件208b延伸，而拉伸线214'缠绕在内管状构件208a周围。拉伸线214’和臂部204通过压接外管状构件208a固定在外管状构件208a和内管状构件208b之间。因此，外管状构件208a由可压接材料制成，例如不锈钢、钛等。内管状构件208b由形状保持材料形成，例如镍钛合金、不锈钢、钛等。在当前示出的实施例中，外管状构件208a具有1.0至1.1毫米的外直径和3毫米的长度。As shown in Figures 30 to 32, the tension wire 214' and the arm 204 are received between the outer tubular member 208a and the inner tubular member 208b. The arm 204 extends along the inner tubular member 208b, and the tension wire 214' is wrapped around the inner tubular member 208a. The tension wire 214' and the arm 204 are fixed between the outer tubular member 208a and the inner tubular member 208b by crimping the outer tubular member 208a. Therefore, the outer tubular member 208a is made of a crimpable material, such as stainless steel, titanium, etc. The inner tubular member 208b is formed of a shape-retaining material, such as nickel-titanium alloy, stainless steel, titanium, etc. In the embodiment currently shown, the outer tubular member 208a has an outer diameter of 1.0 to 1.1 mm and a length of 3 mm.
在图30至图32中，进一步详细地示出了丝线引导构件218的形状。如上所述，丝线引导构件218包括：控制部分220，用于将动力传递到端盖208；刺穿部分219，用于刺穿瓣叶12；以及延伸在控制部分220和刺穿部分219之间的肩部221。在当前示出的实施例中，控制部分220的直径为0.4毫米，刺穿部分219的直径为0.3毫米。肩部221是倾斜的，因此限定了控制部分220和刺穿部分221之间的过渡。In Figures 30 to 32, the shape of the wire guide member 218 is further shown in detail. As described above, the wire guide member 218 includes: a control portion 220 for transmitting power to the end cap 208; a piercing portion 219 for piercing the leaflet 12; and a shoulder 221 extending between the control portion 220 and the piercing portion 219. In the embodiment currently shown, the diameter of the control portion 220 is 0.4 mm and the diameter of the piercing portion 219 is 0.3 mm. The shoulder 221 is inclined, thereby defining the transition between the control portion 220 and the piercing portion 221.
具体转到图30A和图30B中所示的第一布置，端盖208具有钝的末端209。内管状构件208b和外管状构件208a未对准，使得内管状构件208b延伸出外管状构件208a的末端209，并且位于外管状构件208a的开口下方。因此，在端盖208的开口210处，在内管状构件208b和外管状构件208a之间限定了阶梯过渡。该过渡提供了用于与丝线引导构件218的肩部221对接的表面，从而将动力或推力传递到端盖208。Specifically turn to the first arrangement shown in Figure 30A and Figure 30B, end cap 208 has a blunt end 209. Inner tubular member 208b and outer tubular member 208a are misaligned so that inner tubular member 208b extends out of the end 209 of outer tubular member 208a and is positioned below the opening of outer tubular member 208a. Therefore, at the opening 210 of end cap 208, a stepped transition is defined between inner tubular member 208b and outer tubular member 208a. This transition provides a surface for docking with the shoulder 221 of wire guide member 218, thereby power or thrust is transmitted to end cap 208.
在图31A和图31B所示的第二种布置中，端盖208包括圆形末端209。因此，外管状构件208a的末端209本身是锥形或圆形的。为外管状构件208a的末端209提供锥形或喇叭形可以有助于提供过盈配合，以将内管状构件208b保持在外管状构件208a内。此外，内管状构件208a包括限定开口210的喇叭形入口208c，并与外管状构件208a的开口齐平。喇叭形入口208c具有与丝线引导构件218的肩部221互补的形状，以方便丝线引导构件218与端盖208对接。In the second arrangement shown in Figure 31A and Figure 31B, end cap 208 includes circular end 209.Therefore, the end 209 of outer tubular member 208a itself is tapered or circular.Providing tapered or trumpet-shaped for the end 209 of outer tubular member 208a can help to provide interference fit, so that inner tubular member 208b is maintained in outer tubular member 208a.In addition, inner tubular member 208a includes trumpet-shaped inlet 208c that limits opening 210, and is flush with the opening of outer tubular member 208a.Trumpet-shaped inlet 208c has a shape complementary to the shoulder 221 of wire guide member 218, so that wire guide member 218 and end cap 208 docking are convenient.
在图32A和图32B所示的第三种布置中，内管状构件208b还包括与外管状构件208a的开口齐平的喇叭形入口208c。然而，在该第三种布置中，内管状构件208a不延伸出外管状构件208a的末端209。相反，内管状构件208b抵靠外管状构件209a的末端209的内表面。因此，端盖208的末端完全由外管状构件208a的末端209限定。因此，端盖208具有流畅的末端209，以在植入期间利用该末端穿过瓣叶12。In the third arrangement shown in Figures 32A and 32B, the inner tubular member 208b also includes a trumpet-shaped inlet 208c that is flush with the opening of the outer tubular member 208a. However, in this third arrangement, the inner tubular member 208a does not extend beyond the end 209 of the outer tubular member 208a. Instead, the inner tubular member 208b abuts against the inner surface of the end 209 of the outer tubular member 209a. Therefore, the end of the end cap 208 is completely defined by the end 209 of the outer tubular member 208a. Therefore, the end cap 208 has a smooth end 209 to use the end to pass through the leaflet 12 during implantation.
图33A和图33B示出了另一种替代布置的端盖208。图33A示出了端盖208的第一构型，其中，丝线引导构件218未与端盖208对接或接合。在该第一构型中，端盖208的末端209是钝的或圆形的。然而，当丝线引导构件218通过开口208接合端盖208时，端盖208的末端209是尖的，使得其可以刺穿瓣叶12。因此，在图33A和图33B所示的布置中，端盖208的末端209是可伸缩的的尖头末端209。Figures 33A and 33B show another alternative arrangement of the end cap 208. Figure 33A shows a first configuration of the end cap 208, wherein the wire guide member 218 is not docked or engaged with the end cap 208. In this first configuration, the end 209 of the end cap 208 is blunt or rounded. However, when the wire guide member 218 engages the end cap 208 through the opening 208, the end 209 of the end cap 208 is pointed so that it can pierce the leaflet 12. Therefore, in the arrangement shown in Figures 33A and 33B, the end 209 of the end cap 208 is a retractable pointed end 209.
图34示出了另一实施例，其中，丝线引导构件218’与刺穿丝线构件219’是分开的。刺穿丝线构件219’布置成穿行通过端盖208和丝线引导构件218'两者。刺穿丝线构件219’被推动穿过瓣叶12以刺穿瓣叶，并充当用于端盖208和与端盖208接合的丝线引导构件218’的导向件。因此，丝线引导构件218’用于将端盖208推过较细的刺穿丝线构件219'，使得端盖208和附接于其上的臂部204穿过瓣叶12并因此被植入。Figure 34 shows another embodiment, wherein the wire guide member 218' is separate from the piercing wire member 219'. The piercing wire member 219' is arranged to pass through both the end cap 208 and the wire guide member 218'. The piercing wire member 219' is pushed through the leaflet 12 to pierce the leaflet, and acts as a guide for the end cap 208 and the wire guide member 218' engaged with the end cap 208. Therefore, the wire guide member 218' is used to push the end cap 208 through the thinner piercing wire member 219', so that the end cap 208 and the arm 204 attached thereto pass through the leaflet 12 and are therefore implanted.
图35A至图35I示出了软组织锚固系统200在瓣叶12中植入期间的各个阶段。虽然所示的软组织锚固系统200包括端盖208，端盖208具有丝线引导构件218，丝线引导构件218包括穿过其中的刺穿部分219，但将容易地理解的是，本文讨论的植入的一般阶段适用于本文描述的软组织锚固系统200的各种实施例。35A-35I illustrate various stages during implantation of the soft tissue anchoring system 200 in the leaflet 12. Although the illustrated soft tissue anchoring system 200 includes an end cap 208 having a wire guide member 218 including a piercing portion 219 extending therethrough, it will be readily appreciated that the general stages of implantation discussed herein are applicable to the various embodiments of the soft tissue anchoring system 200 described herein.
首先，丝线引导构件218与软组织锚固系统200的每个端盖208接合。通过施加力，使得丝线引导构件218刺穿瓣叶12，并拉动臂部204穿过瓣叶12。在本实施例中，丝线引导构件218的刺穿部分219最初刺穿瓣叶12，并且端盖208在控制部分220的作用下被推动通过植入部位。图35A示出了织物锚固体201的臂部204最初从心房侧穿过瓣叶1。First, the wire guide member 218 is engaged with each end cap 208 of the soft tissue anchor system 200. By applying force, the wire guide member 218 pierces the leaflet 12 and pulls the arm 204 through the leaflet 12. In this embodiment, the piercing portion 219 of the wire guide member 218 initially pierces the leaflet 12, and the end cap 208 is pushed through the implantation site under the action of the control portion 220. FIG. 35A shows that the arm 204 of the fabric anchor 201 initially passes through the leaflet 1 from the atrial side.
然后操纵丝线引导构件218，使得臂部204完全穿过瓣叶12，如图35B所示。当基部202位于瓣叶12附近或与瓣叶12接触时，臂部204完全穿过瓣叶12，如图35C和图35D所示。当臂部204完全植入瓣叶12中时，臂部204的窄腰部203与瓣叶12对齐。The wire guide member 218 is then manipulated so that the arm 204 is completely passed through the leaflet 12, as shown in Figure 35B. When the base 202 is located near the leaflet 12 or in contact with the leaflet 12, the arm 204 is completely passed through the leaflet 12, as shown in Figures 35C and 35D. When the arm 204 is fully implanted in the leaflet 12, the narrow waist 203 of the arm 204 is aligned with the leaflet 12.
一旦臂部204被植入瓣叶12中，便收回丝线引导构件218，使得它们不再接合端盖208，并且经由臂部204的植入部位返回穿过瓣叶12。Once arms 204 are implanted in leaflets 12 , wire guiding members 218 are retracted so that they no longer engage end caps 208 and pass back through leaflets 12 via the implantation site of arms 204 .
随着丝线引导构件218被收回，然后通过拉动人造线214向拉伸线214’施加拉力T。如图35C和图35D所示，人造线214通过系绳结215固定到拉伸线214’。系绳结允许人造线214和拉伸线214’之间的相对移动。拉力T在远离瓣叶12的表面的方向上施加。As the wire guide member 218 is retracted, a tension T is then applied to the stretch wire 214' by pulling the artificial wire 214. As shown in Figures 35C and 35D, the artificial wire 214 is fixed to the stretch wire 214' by a tether knot 215. The tether knot allows relative movement between the artificial wire 214 and the stretch wire 214'. The tension T is applied in a direction away from the surface of the leaflet 12.
施加拉力T导致拉伸线214'被通过瓣叶12回拉。结215相对于瓣叶12的位置将相应地改变，使得结215移动离开基部202(如图35E中所示)。Applying tension T causes tension wire 214' to be pulled back through leaflet 12. The position of knot 215 relative to leaflet 12 will change accordingly, causing knot 215 to move away from base 202 (as shown in FIG35E).
当收回拉伸线214’时，其使臂部204以折叠的方式朝向基部202塌缩，使得瓣叶12被夹在折叠的臂部204和基部202之间。臂部204的手风琴式运动如图35F至图35H所示。由于拉伸线214’经由形成在端盖208的壁中的中心开口211附接到端盖208，并且由于臂部204接近于用于接收丝线引导构件218的开口210连接到端盖208，因此端盖208被推动到与瓣叶12的表面12b/褶层平行的平面中，从而进一步帮助臂部204以折叠的方式塌缩。When the tension wire 214' is retracted, it causes the arm 204 to collapse in a folded manner toward the base 202, so that the leaflet 12 is sandwiched between the folded arm 204 and the base 202. The accordion-like movement of the arm 204 is shown in Figures 35F to 35H. Because the tension wire 214' is attached to the end cap 208 via the central opening 211 formed in the wall of the end cap 208, and because the arm 204 is connected to the end cap 208 close to the opening 210 for receiving the wire guide member 218, the end cap 208 is urged into a plane parallel to the surface 12b/fold of the leaflet 12, thereby further assisting the arm 204 in collapsing in a folded manner.
最后，如图35I所示，端盖208和臂部204的褶层本身位于与瓣叶12的表面12b平行的平面内。Finally, as shown in Figure 35I, the folds of the end cap 208 and the arm portion 204 themselves lie in a plane parallel to the surface 12b of the leaflet 12.
图36A至图36C用于说明包括U形织物体201的软组织锚固系统200的不同构造。图36A是软组织锚固系统200的示意图，并与图36B和图36C形成有用的对比，图36B和图36C分别示出了包括U形织物体201的软组织锚固系统200的原型。36A to 36C are used to illustrate different configurations of a soft tissue anchoring system 200 including a U-shaped fabric body 201. Fig. 36A is a schematic diagram of a soft tissue anchoring system 200 and is usefully contrasted with Figs. 36B and 36C, which respectively illustrate a prototype of a soft tissue anchoring system 200 including a U-shaped fabric body 201.
U形织物体201(如图36B所示)可由一块织物形成，其限定臂部204、窄腰部203和基部202。为了形成基部202，织物体201的一部分可向后折叠在其自身上，并且可以可选地将形状保持构件205夹在其间，如图36B所示。The U-shaped fabric body 201 (as shown in FIG. 36B ) may be formed from a piece of fabric that defines arm portions 204, a narrow waist portion 203, and a base portion 202. To form the base portion 202, a portion of the fabric body 201 may be folded back on itself, and a shape-retaining member 205 may be optionally sandwiched therebetween, as shown in FIG. 36B .
图36C示出了根据本发明的实施例的两个原型软组织锚固系统200。一个锚固系统200包括形状保持构件205(参见原型A)，而另一个锚固系统不包括形状保持构件205(参见原型B)。原型B的长度较短，约为16毫米，而原型A的长度较长。因此，臂部204的长度可以在制造U形织物体201期间改变。FIG36C shows two prototype soft tissue anchoring systems 200 according to an embodiment of the present invention. One anchoring system 200 includes a shape-retaining member 205 (see prototype A), while the other anchoring system does not include a shape-retaining member 205 (see prototype B). Prototype B has a shorter length of approximately 16 mm, while prototype A has a longer length. Therefore, the length of the arm 204 can be changed during the manufacture of the U-shaped fabric body 201.
图37A至图37C示意性地示出了根据本发明的实施例的软组织锚固系统200如何容纳在导管装置中并从导管装置部署。图37A至图37C中的每一个仅示出了导管装置的近端部分1004，但很容易理解的是，这种近端部分1004可以在导管装置中实现，如关于图1至图24中的任何一个所讨论的。37A to 37C schematically illustrate how a soft tissue anchoring system 200 according to an embodiment of the present invention is contained in and deployed from a catheter device. Each of FIG. 37A to 37C shows only a proximal portion 1004 of the catheter device, but it is readily understood that such a proximal portion 1004 may be implemented in a catheter device as discussed with respect to any of FIG. 1 to 24.
图37A示出了软组织锚固系统200的端盖208被容纳在通道或凹槽1208中，用于从导管装置的近端部分1004进行部署。近端部分1004用作夹持壳体1006，因此通道1208面向夹持臂1030，使得当瓣叶12被夹持臂1030抓住时(如图37B所示)，端盖208可以通过致动相应的丝线引导构件218从通道1208部署。37A shows that the end cap 208 of the soft tissue anchoring system 200 is received in the channel or groove 1208 for deployment from the proximal portion 1004 of the catheter device. The proximal portion 1004 serves as the clamp housing 1006, so that the channel 1208 faces the clamp arm 1030, so that when the leaflet 12 is grasped by the clamp arm 1030 (as shown in FIG. 37B), the end cap 208 can be deployed from the channel 1208 by actuating the corresponding wire guide member 218.
导管装置的近端部分1004还提供了用于U形织物体201的壳体1201。图37C示出了当U形织物体201被存放在壳体1201中时的状态。U形织物体壳体1201还面向夹持臂1030，使得U形织物体201能够被植入到所抓握的瓣叶12中。The proximal end portion 1004 of the catheter device also provides a housing 1201 for the U-shaped fabric body 201. Fig. 37C shows the state when the U-shaped fabric body 201 is stored in the housing 1201. The U-shaped fabric body housing 1201 also faces the clamping arm 1030 so that the U-shaped fabric body 201 can be implanted into the grasped leaflet 12.
U形织物体201被放置在壳体1201中的薄管状护套或帘中。护套的作用是减少在从导管装置部署软组织锚固系统200期间U形织物体201与壳体1201之间的摩擦。护套可以在部署期间偏转或皱褶，以协助部署织物体201。The U-shaped fabric body 201 is placed in a thin tubular sheath or curtain in the housing 1201. The function of the sheath is to reduce friction between the U-shaped fabric body 201 and the housing 1201 during deployment of the soft tissue anchor system 200 from the catheter device. The sheath can deflect or wrinkle during deployment to assist in deploying the fabric body 201.
U形织物体壳体1201向用于端盖208的通道1208敞开，使得臂部204能够在端盖通道1208和U形织物体壳体1201之间延伸。因此，这种布置便于软组织锚固系统200从导管装置的近端部分1004顺利部署到所抓握的瓣叶12中。The U-shaped fabric body shell 1201 is open to the channel 1208 for the end cap 208, so that the arm 204 can extend between the end cap channel 1208 and the U-shaped fabric body shell 1201. Therefore, this arrangement facilitates smooth deployment of the soft tissue anchor system 200 from the proximal portion 1004 of the catheter device into the grasped leaflet 12.
图38示出了用于包括U形织物体201的软组织锚200的回收机构。回收机构包括回收轴1300和圈套(snare)1302。回收轴穿线在人造线214上，圈套1302用于通过圈套住基部202来捕获织物体201。圈套1302可以是定制的，也可以是现成的部件。荧光标记(未示出)用于定位圈套1302。一旦基部202被捕获，拉伸线214’中的拉力就会放松，使得可以通过拉动基部202回收软组织锚固系统200，从而在臂部204被通过瓣叶12拉回时展开臂部204。Figure 38 shows a retrieval mechanism for a soft tissue anchor 200 including a U-shaped fabric body 201. The retrieval mechanism includes a retrieval shaft 1300 and a snare 1302. The retrieval shaft is threaded on the artificial line 214, and the snare 1302 is used to capture the fabric body 201 by snare the base 202. The snare 1302 can be customized or an off-the-shelf component. A fluorescent marker (not shown) is used to locate the snare 1302. Once the base 202 is captured, the tension in the stretch line 214' is relaxed, so that the soft tissue anchoring system 200 can be retrieved by pulling the base 202, thereby deploying the arm 204 when the arm 204 is pulled back through the leaflet 12.
图39A至图39D示出了原型软组织锚固系统20的回收步骤。当没有通过拉伸线214’施加拉力时，基部202可以从瓣叶12拉开。因此，臂部204被通过瓣叶12拉回，并随之展开。臂部204的伸展开导致端盖208自复位，使得它们与臂部204共线地延伸并且优选地垂直于瓣叶12的表面12b。最后，端盖208穿过瓣叶12。39A to 39D illustrate the retrieval steps of the prototype soft tissue anchoring system 20. When no tension is applied by the tension wire 214', the base 202 can be pulled away from the leaflet 12. As a result, the arm 204 is pulled back through the leaflet 12 and then unfolds. The extension of the arm 204 causes the end caps 208 to self-reset so that they extend colinearly with the arm 204 and preferably perpendicular to the surface 12b of the leaflet 12. Finally, the end caps 208 pass through the leaflet 12.
图40示出了替代布置的端盖208，端盖208包括尖头末端209。端盖208包括外管状构件208a，外管状构件208a包括形成在其壁中、用于接收拉伸线214’的开口211和凹口212，该凹口用于方便将端盖208附接到织物体201的臂部204。内管状构件208b嵌套在外管状构件208a内，内管状构件208b限定用于接收丝线引导构件218的开口。FIG40 shows an alternative arrangement of an end cap 208, which includes a pointed tip 209. The end cap 208 includes an outer tubular member 208a, which includes an opening 211 formed in its wall for receiving a tension wire 214' and a notch 212, which is used to facilitate attachment of the end cap 208 to the arm 204 of the fabric body 201. An inner tubular member 208b is nested within the outer tubular member 208a, and the inner tubular member 208b defines an opening for receiving a wire guide member 218.
尖头末端209包括斜面209a。斜面209a限定了其中形成有尖头末端209的斜面的面。尖头末端209还包括两个尖拱平面(lancet plane)209b，这两个尖拱平面对称地位于斜面209a的两侧。尖头末端209的这种构造可以减少在植入软组织锚固系统200期间刺穿瓣叶12所需的力，从而减少植入期间经历的创伤。The pointed tip 209 includes a bevel 209a. Bevel 209a defines a surface in which the bevel of the pointed tip 209 is formed. The pointed tip 209 also includes two lancet planes 209b, which are symmetrically located on both sides of the bevel 209a. This configuration of the pointed tip 209 can reduce the force required to pierce the leaflet 12 during implantation of the soft tissue anchoring system 200, thereby reducing the trauma experienced during implantation.
图41以平面图示出了原型软组织锚固系统200。端盖208包括尖头末端209，用于将拉伸线214’固定至人造线215的结215是固定结215，从而防止拉伸线214’相对于人造线215移动。根据该实施例的软组织锚固系统200不具有形状保持构件205和加强元件206，但在不同实施例中，这种软组织锚固系统200可以具有这些特征。Fig. 41 shows a prototype soft tissue anchoring system 200 in a plan view. The end cap 208 includes a pointed end 209, and the knot 215 for fixing the tensile wire 214' to the artificial wire 215 is a fixed knot 215, thereby preventing the tensile wire 214' from moving relative to the artificial wire 215. The soft tissue anchoring system 200 according to this embodiment does not have a shape retaining member 205 and a reinforcing element 206, but in different embodiments, such a soft tissue anchoring system 200 may have these features.
针对每个臂部204，拉伸线214’穿线通过形成在臂部204中的孔207’、形成在窄腰部203中的孔207”以及形成在基部中的孔207”'。这种布置可以改善织物体201在身体软组织周围的压缩，因为在窄腰部203中设置孔207”(该孔207”朝向基部202定位)可以促使基部202和臂部204朝向身体软组织塌缩，从而改善软组织锚固系统200在植入时的稳定性。For each arm 204, a stretch wire 214' is threaded through a hole 207' formed in the arm 204, a hole 207" formed in the narrow waist 203, and a hole 207"' formed in the base. This arrangement can improve the compression of the fabric body 201 around the soft tissue of the body, because the hole 207" (the hole 207" is positioned toward the base 202) in the narrow waist 203 can cause the base 202 and the arm 204 to collapse toward the soft tissue of the body, thereby improving the stability of the soft tissue anchoring system 200 during implantation.
图42示出了端盖208的替代布置。在这种布置中，端盖208包括外管状构件208a，该外管状构件包括尖头末端209、用于接收拉伸线214’的开口211和用于接收织物体201的臂部204的凹口212。端盖208还包括嵌套在外管状构件208a内的内管状构件208b。内管状构件208b包括喇叭形入口208c，该喇叭形入口限定用于接收丝线引导构件218的开口210。FIG. 42 shows an alternative arrangement of the end cap 208. In this arrangement, the end cap 208 includes an outer tubular member 208a, which includes a pointed end 209, an opening 211 for receiving a tension wire 214', and a notch 212 for receiving the arm 204 of the fabric body 201. The end cap 208 also includes an inner tubular member 208b nested within the outer tubular member 208a. The inner tubular member 208b includes a flared inlet 208c, which defines an opening 210 for receiving a wire guide member 218.
在本实施例中，外管状构件208a被配置成通过压配合保持内管状构件208b。内管状构件208b的远离喇叭形入口208c的一端被配置成与外管状构件208a的互补凹口配合，使得内管状构件208b通过过盈配合保持。此外，内管状构件208b的喇叭形入口208c被布置成抵靠外管状构件208a的内壁或表面，从而再次加强压配合配合。In this embodiment, the outer tubular member 208a is configured to retain the inner tubular member 208b by a press fit. The end of the inner tubular member 208b away from the flared inlet 208c is configured to mate with a complementary recess of the outer tubular member 208a, so that the inner tubular member 208b is retained by an interference fit. In addition, the flared inlet 208c of the inner tubular member 208b is arranged to abut against the inner wall or surface of the outer tubular member 208a, thereby again strengthening the press fit.
根据本发明的实施例，上述端盖208本身可用作软组织锚固系统200的一部分。当端盖208本身用作锚固构件时，可将其视为管状盖构件208。因此，根据本发明的软组织锚固系统200可并非必需设有U形织物体201，或者根本不设有织物体。According to an embodiment of the present invention, the end cap 208 itself may be used as a part of the soft tissue anchoring system 200. When the end cap 208 itself is used as an anchoring member, it may be regarded as a tubular cap member 208. Therefore, the soft tissue anchoring system 200 according to the present invention may not necessarily be provided with the U-shaped fabric body 201, or may not be provided with a fabric body at all.
图43A至图43D示出了软组织锚固系统200，其包括管状盖构件208和拉伸线214’，处于其在瓣叶12中植入的不同步骤中。虽然图43A至图43D中所示的管状盖构件208(并且如本文所述)具有与图42相关的结构，但可以容易地理解，植入管状盖构件208的一般原理和教导可以应用于上述任何端盖208。43A-43D illustrate the soft tissue anchoring system 200, including the tubular cover member 208 and the tension wire 214', at various stages of its implantation in the leaflet 12. Although the tubular cover member 208 illustrated in FIGS. 43A-43D (and as described herein) has the structure associated with FIG. 42, it can be readily appreciated that the general principles and teachings of implanting the tubular cover member 208 can be applied to any of the end caps 208 described above.
在本实施例中，软组织锚固系统200仅包括单个管状盖构件208和与管状盖构件208结合的拉伸线214’。然而，在其他实施例中，管状盖构件208可设有包括臂部和基部的织物体。也可使用多个管状盖构件208作为同一软组织锚固系统的一部分，而不偏离关于图43A至图43D讨论的安装步骤。In this embodiment, the soft tissue anchoring system 200 includes only a single tubular cover member 208 and a tensile wire 214' coupled to the tubular cover member 208. However, in other embodiments, the tubular cover member 208 may be provided with a fabric body including an arm portion and a base portion. Multiple tubular cover members 208 may also be used as part of the same soft tissue anchoring system without deviating from the installation steps discussed with respect to FIGS. 43A to 43D.
为了将软组织锚固系统200植入瓣叶12中，丝线引导构件218通过开口210与管状盖构件208接合。然后使用丝线引导构件218将管状盖构件208推入瓣叶12中，使得管状盖构件208刺穿瓣叶12，如图43A所示。To implant soft tissue anchor system 200 into leaflets 12, wire guide member 218 engages tubular cover member 208 through opening 210. Wire guide member 218 is then used to push tubular cover member 208 into leaflets 12 so that tubular cover member 208 pierces leaflets 12, as shown in FIG. 43A.
丝线引导构件218继续对管状盖构件208施加动力，使得管状盖构件208完全穿过瓣叶12，如图43B所示。Wire guide member 218 continues to apply power to tubular cover member 208 so that tubular cover member 208 passes completely through leaflet 12, as shown in FIG. 43B.
随后，丝线引导构件218被拉出，管状盖构件208自其被植入的位置处悬置于瓣叶12的相对侧上(见图43C)。拉伸线214’仍延伸穿过植入部位12c。Subsequently, the wire guide member 218 is pulled out and the tubular cover member 208 is suspended from the position where it was implanted on the opposite side of the leaflet 12 (see FIG. 43C ). The tension wire 214 'still extends through the implantation site 12c.
最后，将拉力T施加到拉伸线214'，该拉力在远离管状盖构件208被植入其中的表面12a的方向上施加。施加该拉力T导致管状盖构件208在与瓣叶的表面12b平行的平面中延伸，并且在本实施例中直接抵靠该表面12b，如图43D所示。Finally, a tension T is applied to the stretch wire 214' in a direction away from the surface 12a in which the tubular cover member 208 is implanted. Applying this tension T causes the tubular cover member 208 to extend in a plane parallel to the surface 12b of the leaflet and, in this embodiment, directly against the surface 12b, as shown in Figure 43D.
如图42和图43A至图43D所示，拉伸线214’从其延伸的开口211更靠近于用于接收丝线引导构件218的开口210而定位，而不是靠近于管状盖构件208的末端209。靠近末端209，管状盖构件208由于较窄而具有较小的投影面积。因此，通过将拉伸线214’靠近开口210(在此处，管状盖构件208由于较宽而具有较大的投影面积)布置，管状盖构件208能够以拉伸线214’两侧相等的投影面积接触瓣叶12的表面12b，从而导致管状盖构件208与瓣叶表面12b的更稳定抵接。As shown in Figures 42 and 43A to 43D, the opening 211 from which the stretch wire 214' extends is positioned closer to the opening 210 for receiving the wire guide member 218, rather than closer to the end 209 of the tubular cover member 208. Close to the end 209, the tubular cover member 208 has a smaller projected area due to being narrower. Therefore, by arranging the stretch wire 214' close to the opening 210 (where the tubular cover member 208 has a larger projected area due to being wider), the tubular cover member 208 can contact the surface 12b of the leaflet 12 with equal projected areas on both sides of the stretch wire 214', thereby resulting in a more stable abutment of the tubular cover member 208 with the leaflet surface 12b.
图44示出了根据本发明的实施例，用于植入锚固构件的丝线引导构件218被锚固构件接收。在图示的实施例中，锚固构件是管状盖构件208。但是，锚固构件也可以是臂部204的端盖208。丝线引导构件218包括导引部分(其在当前图示的实施例中是刺穿部分219)和控制部分220。然而，在其他实施例中，导引部分可以只是较细的丝线部分，其被配置成被管状盖构件208接收，该管状盖构件具有尖头末端209，用于刺穿软组织。控制部分220比刺穿部分219厚。控制部分220与刺穿部分219之间设有凸起部分221'。凸起部分221'的直径比控制部分220和刺穿部分219的直径都大。Figure 44 shows an embodiment of the present invention, and a wire guide member 218 for implanting an anchoring member is received by the anchoring member. In the illustrated embodiment, the anchoring member is a tubular cover member 208. However, the anchoring member can also be the end cap 208 of the arm 204. The wire guide member 218 includes a guide portion (which is a piercing portion 219 in the current illustrated embodiment) and a control portion 220. However, in other embodiments, the guide portion can be only a thinner wire portion, which is configured to be received by the tubular cover member 208, and the tubular cover member has a pointed end 209 for piercing soft tissue. The control portion 220 is thicker than the piercing portion 219. A raised portion 221' is provided between the control portion 220 and the piercing portion 219. The diameter of the raised portion 221' is larger than the diameter of the control portion 220 and the piercing portion 219.
凸起部分221’被配置成与管状盖构件208的喇叭形入口208c接合，使得丝线引导构件218可在软组织锚固系统200的植入期间向管状盖构件208提供动力。凸起部分221’还被配置成与位于用于植入软组织锚固系统200的导管装置中的互补抵接部分1021接合，如下面关于图45的讨论。The raised portion 221' is configured to engage with the flared inlet 208c of the tubular cover member 208 so that the wire guide member 218 can provide power to the tubular cover member 208 during implantation of the soft tissue anchor system 200. The raised portion 221' is also configured to engage with a complementary abutment portion 1021 located in a catheter device for implanting the soft tissue anchor system 200, as discussed below with respect to FIG.
图45示意性地示出了用于在瓣叶12中植入软组织锚固系统200的部署系统300。部署系统300属于导管装置2，例如关于图1至图24中任一个讨论的导管装置。软组织锚固系统200包括多个锚固构件，在当前示出的实施例中，这些锚固构件是包括U形织物体201的软组织锚固系统200的端盖208。然而，在其他实施例中，它们可以是如关于图43A至图43D所述的管状盖构件208。FIG45 schematically illustrates a deployment system 300 for implanting a soft tissue anchoring system 200 in a leaflet 12. The deployment system 300 pertains to a catheter device 2, such as the catheter device discussed with respect to any of FIGS. 1 to 24. The soft tissue anchoring system 200 comprises a plurality of anchoring members, which in the presently illustrated embodiment are end caps 208 of the soft tissue anchoring system 200 comprising a U-shaped fabric body 201. However, in other embodiments, they may be tubular cap members 208 as described with respect to FIGS. 43A to 43D.
在将导管装置递送到植入部位(例如瓣叶12)期间，丝线引导构件218可能由于导管装置的递送轴的弯曲而经历弯曲。位于该弯曲内侧的第一丝线引导构件218将经历第一曲率半径R1。位于该弯曲外侧的第二丝线引导构件218将经历不同的第二曲率半径R2。第二曲率半径R2大于第一曲率半径R1。因此，第二丝线引导构件218必须比第一丝线引导构件218横穿更大的距离才能到达其各自的端盖208。During delivery of the catheter device to the implantation site (e.g., leaflet 12), the wire guide member 218 may experience a bend due to the curvature of the delivery shaft of the catheter device. The first wire guide member 218 located on the inner side of the bend will experience a first radius of curvatureR1 . The second wire guide member 218 located on the outer side of the bend will experience a different second radius of curvatureR2 . The second radius of curvatureR2 is greater than the first radius of curvatureR1 . Therefore, the second wire guide member 218 must traverse a greater distance than the first wire guide member 218 to reach its respective end cap 208.
在本发明的优选实施例中，单个织物体201的每个端盖208将被同时地植入身体软组织12中。但是，如果一个丝线引导构件218比另一个丝线引导构件穿行过的距离大，则端盖208可能不会同时植入身体软组织12中。因此，在当前示出的实施例中，导管装置包括被配置为同时将每个端盖208部署在瓣叶12中的部署系统300。In a preferred embodiment of the present invention, each end cap 208 of a single fabric body 201 will be implanted simultaneously in the body soft tissue 12. However, if one wire guide member 218 travels a greater distance than another wire guide member, the end caps 208 may not be implanted simultaneously in the body soft tissue 12. Therefore, in the presently illustrated embodiment, the catheter device includes a deployment system 300 configured to deploy each end cap 208 in the leaflet 12 simultaneously.
部署系统300包括多个丝线引导构件218和抵接部分1021。抵接部分1021的作用是防止每个丝线引导构件218被拉入导管装置超过一定距离，因此当丝线引导构件218被拉向近端(即进入递送轴)时，通过抵接凸起部分221’来提供限制丝线引导构件218在近端方向上的平移的障碍物。The deployment system 300 includes a plurality of wire guide members 218 and an abutment portion 1021. The function of the abutment portion 1021 is to prevent each wire guide member 218 from being pulled into the catheter device beyond a certain distance, so that when the wire guide member 218 is pulled proximally (i.e., into the delivery shaft), an obstacle is provided to limit the translation of the wire guide member 218 in the proximal direction by abutting the raised portion 221'.
抵接部分1021位于导管装置的壳体的近端部分1004中。因此，它们位于递送轴内的丝线引导构件218发生任何可能的偏转之后，因此能够恢复丝线引导构件218的共面对准。The abutment portions 1021 are located in the proximal portion 1004 of the housing of the catheter device. Therefore, they are located after any possible deflection of the wire guiding member 218 within the delivery shaft, thus enabling the coplanar alignment of the wire guiding member 218 to be restored.
本实施例的部署系统300还包括弹簧装置230。在本实施例中，弹簧装置230位于导管装置的递送手柄中，但在其他实施例中，它可以位于其他地方。弹簧装置230被配置为将丝线引导构件218朝向递送轴/近端方向偏置。因此，弹簧装置230将凸起部分221’朝向抵接部分1021偏压。The deployment system 300 of the present embodiment also includes a spring device 230. In the present embodiment, the spring device 230 is located in the delivery handle of the catheter device, but in other embodiments, it can be located elsewhere. The spring device 230 is configured to bias the wire guide member 218 toward the delivery axis/proximal direction. Therefore, the spring device 230 biases the raised portion 221 'toward the abutment portion 1021.
由于丝线引导构件218在远端(即，与端盖构件208接合的端部)处处于共面对准，而不管丝线引导构件218在递送轴内的偏转如何，所以各丝线引导构件218可以通过同一平移输入被同时地操作，以实现它们各自接合的端盖208的同时植入。Because the wire guide members 218 are in coplanar alignment at the distal end (i.e., the end that engages with the end cap member 208), regardless of the deflection of the wire guide members 218 within the delivery axis, each wire guide member 218 can be simultaneously operated by the same translation input to achieve simultaneous implantation of the end caps 208 to which they are respectively engaged.
图46A示出了植入在心脏的二尖瓣瓣叶12中的软组织锚固系统200。软组织锚固系统200从心房侧植入，使得软组织锚固系统200的基部202邻近瓣叶12的心房表面。因此，软组织锚固系统200的线214、214'在瓣叶12的自由边缘上下落。在这种配置中，线214、214可为瓣叶边缘提供支撑。46A shows a soft tissue anchoring system 200 implanted in a mitral valve leaflet 12 of a heart. The soft tissue anchoring system 200 is implanted from the atrial side so that the base 202 of the soft tissue anchoring system 200 is adjacent to the atrial surface of the leaflet 12. Thus, the wires 214, 214' of the soft tissue anchoring system 200 fall over the free edge of the leaflet 12. In this configuration, the wires 214, 214 can provide support for the leaflet edge.
图46B示出了从瓣叶12的心室侧观察的软组织锚固系统200。臂部204邻近瓣叶12的心室表面12b，由于线214’处于拉力之下，因此端盖208位于与心室表面12b平行的平面中。Fig. 46B shows the soft tissue anchoring system 200 as viewed from the ventricular side of the leaflet 12. The arm portion 204 is adjacent to the ventricular surface 12b of the leaflet 12, and because the wire 214' is under tension, the end cap 208 lies in a plane parallel to the ventricular surface 12b.
图46B更详细地示出了作用在线214、214'上的拉力。可以认为拉伸线214’包括多条系绳线。每条系绳线214’穿线通过相应的臂部204，并连接到相应的端盖208。然后，每条系绳线214’以固定方式连接到公共系绳点215，如图46B所示，该公共系绳点是固定的结215。人造线214也连接到系绳点215，并沿远离瓣叶12的方向延伸。FIG. 46B shows the tension acting on the lines 214, 214' in more detail. It can be considered that the tension line 214' includes multiple tether lines. Each tether line 214' is threaded through the corresponding arm 204 and connected to the corresponding end cap 208. Each tether line 214' is then connected to a common tether point 215 in a fixed manner, as shown in FIG. 46B, which is a fixed knot 215. The artificial line 214 is also connected to the tether point 215 and extends in a direction away from the leaflet 12.
单一的拉力F1被施加到人造线214上。为了便于解释，可以认为拉力F1在单一的垂直方向上施加拉力。施加拉力F1使系绳点215处于拉力之下。由于系绳点215连接到多条系绳线214’，因此该拉力也施加到每条系绳线214’上。但是，由于系绳点215提供了每条系绳线214’分叉的共同位置，最终作用在每条系绳线214’上的拉力F2具有水平分量和垂直分量。这是系绳点215将拉力F1分布在每条系绳线214’上的结果，也是人造线214和拉伸线214’的整体Y形配置的结果。A single tension F1 is applied to the artificial line 214. For ease of explanation, it can be considered that the tension F1 applies tension in a single vertical direction. The application of tension F1 puts the tether point 215 under tension. Since the tether point 215 is connected to multiple tether lines 214', the tension is also applied to each tether line 214'. However, since the tether point 215 provides a common location for each tether line 214' to branch off, the tension F2 that ultimately acts on each tether line 214' has a horizontal component and a vertical component. This is the result of the tether point 215 distributing the tension F1 on each tether line 214', and is also the result of the overall Y-shaped configuration of the artificial line 214 and the tensile line 214'.
由于拉力F2具有沿与施加到系绳点215的单一的拉力F1垂直的方向上的拉力分量，因此臂部204和端盖208受到作用在水平方向上的拉力F3。该拉力F3用于将臂部204和端盖208拉向与系绳点215和施加该单一的拉力F1的方向都相交的平面。因此，臂部204和端盖208可以用于以挤压的方式将瓣叶12的组织拉在一起。因此，拉力F3的整体作用可以“捕获”瓣叶12的位于臂部204和端盖208之间的多余组织，从而恢复瓣叶12的形状和/或为瓣叶结构12提供额外的结构支撑。Since the tension F2 has a tension component in a direction perpendicular to the single tension F1 applied to the tether point 215, the arm 204 and the end cap 208 are subjected to a tension F3 acting in the horizontal direction. The tension F3 is used to pull the arm 204 and the end cap 208 toward a plane that intersects both the tether point 215 and the direction in which the single tension F1 is applied. Therefore, the arm 204 and the end cap 208 can be used to pull the tissue of the leaflet 12 together in a compressive manner. Therefore, the overall effect of the tension F3 can "capture" excess tissue of the leaflet 12 located between the arm 204 and the end cap 208, thereby restoring the shape of the leaflet 12 and/or providing additional structural support to the leaflet structure 12.
已发现如上所述的由于捕获多余的瓣叶组织而对瓣叶12的组织进行重塑提供了类似于瓣叶切除术的结果。切除术是现有的心脏瓣膜修复方法中的常见手术步骤，其中，外科医生切除心脏瓣膜的受损部分并将剩余的组织的边缘缝合在一起。切除术通常在存在多余的瓣叶组织的情况下进行。然而，通过提供包括系绳点215和多条系绳线214’的线布置，可以避免对切除步骤的需要。这可以简化整个手术过程。It has been found that remodeling the tissue of the leaflet 12 as described above due to capturing excess leaflet tissue provides results similar to leaflet resection. Leaflet resection is a common surgical step in existing heart valve repair methods, in which a surgeon removes a damaged portion of the heart valve and sutures the edges of the remaining tissue together. Resection is typically performed in the presence of excess leaflet tissue. However, by providing a line arrangement including a tether point 215 and a plurality of tether lines 214', the need for a resection step can be avoided. This can simplify the entire surgical procedure.
软组织锚固系统200的织物体201的设计可在制造之前改变，例如通过调整基部202和臂部204的尺寸，或者通过调整设计中包含的臂部204和相应端盖208的数量，以便于捕获所需量的瓣叶组织，从而提供合适的“切除”效果。The design of the fabric body 201 of the soft tissue anchoring system 200 can be changed prior to manufacturing, for example by adjusting the size of the base 202 and the arms 204, or by adjusting the number of arms 204 and corresponding end caps 208 included in the design, so as to capture the desired amount of leaflet tissue to provide a suitable "resection" effect.
以下项列出了本发明的特征和实施例，这些特征和实施例当前可能在本申请中被要求保护也可能没有，但是它们可以形成将来的权利要求、权利要求修改或分案申请的基础。The following items list features and embodiments of the invention which may or may not be presently claimed in the present application, but which may form the basis for future claims, claim amendments, or divisional applications.
1.一种软组织锚固系统，用于植入身体软组织中以保持人造线，所述软组织锚固系统包括：1. A soft tissue anchoring system for implantation in body soft tissue to hold an artificial thread, the soft tissue anchoring system comprising:
U形织物体，其包括基部和从基部延伸的至少两个臂部；以及A U-shaped fabric body including a base and at least two arms extending from the base; and
用于使每个臂部以折叠方式朝向基部塌缩，使得在使用中身体组织被夹在基部和各个臂部之间的装置。Means for collapsing each arm towards the base in a folded manner such that in use body tissue is sandwiched between the base and each arm.
2.在根据项1所述的软组织锚固系统中，用于使每个臂部以折叠方式朝向基部塌缩的装置包括穿线通过每个臂部和基部的拉伸线；2. In the soft tissue anchoring system according to item 1, the means for causing each arm to collapse toward the base in a folded manner comprises a tensile wire threaded through each arm and the base;
其中，该拉伸线被配置为当对拉伸线施加拉力时，使每个臂部以折叠方式朝向基部塌缩。The stretch line is configured to cause each arm to collapse toward the base in a folded manner when tension is applied to the stretch line.
3.在根据项2所述的软组织锚固系统中，拉伸线固定到每个臂部，位于臂部的远离基部的端部处。3. In the soft tissue anchoring system according to item 2, the tension wire is fixed to each arm at the end of the arm away from the base.
4.根据项2或3所述的软组织锚固系统包括：4. The soft tissue anchoring system according to item 2 or 3 comprises:
人造线；Man-made lines;
其中，人造线可滑动地连接至拉伸线的穿线通过基部的部分；并且wherein the synthetic line is slidably connected to the portion of the tensile line through which the line is threaded through the base; and
其中，人造线被配置为将拉力施加到拉伸线上。Therein, the artificial line is configured to apply tension to the tensile line.
5.在根据项2、3或4所述的软组织锚固系统中，织物体包括加强构件。5. In the soft tissue anchoring system according to item 2, 3 or 4, the fabric body includes a reinforcing member.
6.在根据前述任一项所述的软组织锚固系统中，每个臂部包括固定在每个臂部的远离基部的一端处的端盖；6. In the soft tissue anchoring system according to any of the preceding claims, each arm comprises an end cap fixed at an end of each arm away from the base;
其中，每个端盖包括配置为接合丝线引导构件的开口，用于将U形织物体植入身体组织中。Each end cap includes an opening configured to engage a wire guiding member for implanting the U-shaped fabric body into body tissue.
7.在根据项6所述的软组织锚固系统中，每个端盖包括外管状构件和内管状构件，其中，外管状构件被配置成接收内管状构件；并且7. In the soft tissue anchoring system according to item 6, each end cap comprises an outer tubular member and an inner tubular member, wherein the outer tubular member is configured to receive the inner tubular member; and
其中，内管状构件限定了配置为接合丝线引导构件的开口。Therein, the inner tubular member defines an opening configured to engage the wire guiding member.
8.在根据项6或7所述的软组织锚固系统中，内管状构件包括喇叭形入口，该喇叭形入口限定被构造成与丝线引导构件接合的所述开口；8. In the soft tissue anchoring system according to item 6 or 7, the inner tubular member comprises a trumpet-shaped inlet defining the opening configured to engage with the wire guiding member;
可选地，其中，喇叭形入口被配置为与丝线引导构件的相应部分配合。Optionally, wherein the trumpet-shaped inlet is configured to cooperate with a corresponding part of the wire guiding member.
9.在根据项6、7或8的软组织锚固系统中，外管状构件包括位于端盖的末端处的锥形部分。9. In the soft tissue anchoring system according to item 6, 7 or 8, the outer tubular member includes a tapered portion at the distal end of the end cap.
10.在根据项6至9中任一项的软组织锚固系统中，端盖的远离基部的末端是钝的和/或圆形末端。10. In the soft tissue anchoring system according to any one of items 6 to 9, the end of the end cap away from the base is a blunt and/or rounded end.
11.在根据项6至9中任一项的软组织锚固系统中，端盖的远离基部的末端是配置为刺穿身体组织的尖头末端；11. In the soft tissue anchoring system according to any one of items 6 to 9, the end of the end cap away from the base is a pointed end configured to pierce body tissue;
可选地，其中，该尖头末端包括斜面；或者Optionally, wherein the pointed end comprises a bevel; or
可选地，其中，该尖头末端是可伸缩的尖头末端，使得端盖的末端在静止时是钝的和/或圆形，并且其中，当丝线引导构件接合端盖时，该末端是尖头的。Optionally, wherein the pointed tip is a retractable pointed tip such that the tip of the end cap is blunt and/or rounded when at rest, and wherein the tip is pointed when the wire guiding member engages the end cap.
12.根据项6至11中任一项的软组织锚固系统中，外管状构件包括侧壁和形成在侧壁中的孔口，其中，所述孔口接收所述线；和/或12. The soft tissue anchoring system according to any one of items 6 to 11, wherein the outer tubular member comprises a side wall and an aperture formed in the side wall, wherein the aperture receives the wire; and/or
其中，拉伸线通过将拉伸线压接、夹紧和/或夹在外管状构件和内管状构件之间而固定到每个端盖。Therein, the tensile wire is secured to each end cap by crimping, clamping and/or sandwiching the tensile wire between the outer tubular member and the inner tubular member.
13.根据项6至12中任一项的软组织锚固系统中，拉伸线在端盖的中央区域处和/或接近于端盖的远离基部的末端固定至每个端盖。13. In the soft tissue anchoring system according to any one of items 6 to 12, the tension wire is fixed to each end cap at a central region of the end cap and/or close to an end of the end cap distal to the base.
14.如项13所述的软组织锚固系统中，每个端盖被配置为在U形织物体的植入和/或收回过程中与相应的臂部共线延伸；并且14. In the soft tissue anchoring system of claim 13, each end cap is configured to extend colinearly with the corresponding arm during implantation and/or retrieval of the U-shaped fabric body; and
其中，每个端盖被配置为在拉力施加到拉伸线时平行于相应的臂部的每个褶层的平面延伸。Wherein each end cap is configured to extend parallel to a plane of each pleat of the corresponding arm when tension is applied to the tension line.
15.根据前述任一项所述的软组织锚固系统中，基部限定了U形织物体的最大宽度。15. In the soft tissue anchoring system according to any of the preceding items, the base defines a maximum width of the U-shaped fabric body.
16.根据前述任一项所述的软组织锚固系统，其中，基部包括形状保持构件，该形状保持构件被配置成增加基部的侧向刚度。16. A soft tissue anchor system according to any of the preceding claims, wherein the base comprises a shape retaining member configured to increase the lateral stiffness of the base.
17.根据前述任一项所述的软组织锚固系统，其中，所述软组织锚固系统是用于植入心脏瓣膜瓣叶中以保持人造腱索的瓣叶锚固系统；17. The soft tissue anchoring system according to any of the preceding claims, wherein the soft tissue anchoring system is a leaflet anchoring system for implantation in a heart valve leaflet to hold an artificial chordae tendineae;
可选地，其中，心脏瓣膜是二尖瓣。Optionally, wherein the heart valve is a mitral valve.
18.一种用于在心脏组织中植入软组织锚固系统的导管装置，该导管装置包括：18. A catheter device for implanting a soft tissue anchoring system in cardiac tissue, the catheter device comprising:
壳体部分，其中，壳体部分从导管装置的远端沿导管装置的长度向导管装置的近端延伸；以及a housing portion, wherein the housing portion extends from a distal end of the catheter device along the length of the catheter device to a proximal end of the catheter device; and
位于壳体部分内的根据前述权利要求中任一项所述的软组织锚固系统。A soft tissue anchoring system according to any one of the preceding claims located within a housing portion.
19.根据第18项所述的导管装置，包括：19. The catheter device according to item 18, comprising:
用于部署软组织锚固系统的丝线引导构件。A wire guide member for deploying a soft tissue anchoring system.
20.根据项19所述的导管装置，其中，丝线引导构件包括肩部；以及20. The catheter device of clause 19, wherein the wire guiding member comprises a shoulder; and
其中，壳体部分包括止动部分，该止动部分被配置为与肩部配合，从而限制丝线引导构件在壳体部分中的远端平移。Therein, the housing portion comprises a stop portion configured to cooperate with the shoulder portion to limit distal translation of the wire guiding member in the housing portion.
21.根据项20所述的导管装置，包括：21. The catheter device of claim 20, comprising:
用于放置在心脏瓣膜的瓣叶中的瓣叶锚，其中，瓣叶锚是前述项中任一项的软组织锚，其中，瓣叶锚布置成与人造线联接；以及A leaflet anchor for placement in a leaflet of a heart valve, wherein the leaflet anchor is a soft tissue anchor as in any of the preceding items, wherein the leaflet anchor is arranged to couple with an artificial thread; and
瓣叶锚部署机构，用于部署瓣叶锚，将其附着到心脏的瓣叶上。The leaflet anchor deployment mechanism is used to deploy the leaflet anchor to attach it to the leaflet of the heart.
22.如权利要求21所述的导管装置，包括：22. The catheter device of claim 21, comprising:
用于抓握心脏瓣膜的瓣叶的机械夹持装置；以及Mechanical gripping devices for grasping leaflets of heart valves; and
瓣叶锚管，用于在瓣叶锚部署到身体组织之前容纳瓣叶锚；a leaflet anchor tube for receiving the leaflet anchor prior to deployment of the leaflet anchor into body tissue;
其中，夹持装置和瓣叶锚被布置成使得当在使用中夹持装置抓握住瓣叶时，瓣叶锚固系统可以被推出瓣叶锚管以刺穿瓣叶并部署锚，使得其被植入瓣叶中。Therein, the clamping device and the leaflet anchor are arranged so that when the clamping device grasps the leaflet in use, the leaflet anchoring system can be pushed out of the leaflet anchor tube to pierce the leaflet and deploy the anchor so that it is implanted in the leaflet.
23.如权利要求22所述的导管装置，其中，夹持装置包括夹持臂，其可旋转地联接到导管装置的主体，使得夹持臂被配置为相对于导管装置旋转，以使夹持臂的外端部被移离导管装置的主体。23. A catheter device as described in claim 22, wherein the clamping device includes a clamping arm which is rotatably connected to the body of the catheter device, so that the clamping arm is configured to rotate relative to the catheter device so that the outer end of the clamping arm is moved away from the body of the catheter device.
24.如权利要求23所述的导管装置，其中，夹持臂包括形成于夹持臂的基部的狭槽，并且其中，夹持臂通过所述狭槽可旋转地联接到主体，使得夹持臂被配置为远离导管装置的主体平移。24. A catheter device as described in claim 23, wherein the clamping arm includes a narrow slot formed at the base of the clamping arm, and wherein the clamping arm is rotatably connected to the body via the narrow slot so that the clamping arm is configured to translate away from the body of the catheter device.
25.在身体软组织中植入根据项1至17中任一项的软组织锚固系统的方法，该方法包括：25. A method of implanting a soft tissue anchoring system according to any one of items 1 to 17 in a body soft tissue, the method comprising:
使用相应的丝线引导构件接合每个臂部；engaging each arm portion with a respective wire guiding member;
使用相应的丝线引导构件将每个臂部推过身体组织；advancing each arm through body tissue using a corresponding wire guide member;
拉出各个相应的丝线引导构件；以及pulling out each corresponding wire guiding member; and
将每个臂部以折叠方式朝向基部塌缩，使得身体组织被夹在基部和每个臂部之间。Each arm is collapsed toward the base in a folded manner such that body tissue is sandwiched between the base and each arm.
26.一种用于植入身体软组织中以保持线的软组织锚固系统，所述软组织锚固系统包括：26. A soft tissue anchoring system for implantation in body soft tissue to hold a wire, the soft tissue anchoring system comprising:
U形织物体，包括基部和从基部延伸的至少两个臂部；以及A U-shaped fabric body including a base and at least two arms extending from the base; and
用于使每个臂部以折叠方式朝向基部塌缩使得在使用中身体组织被夹在基部和每个臂部之间的装置。Means for collapsing each arm towards the base in a folded manner such that in use body tissue is sandwiched between the base and each arm.
27.如项26所述的软组织锚固系统，其中，每个臂部包括固定在臂部的远离基部一端的端盖，其中，每个端盖配置为接收丝线引导构件，其用于将锚植入身体组织中并在植入期间拉动臂部通过身体组织。27. A soft tissue anchoring system as described in claim 26, wherein each arm includes an end cap fixed to an end of the arm away from the base, wherein each end cap is configured to receive a wire guide member for implanting the anchor into body tissue and pulling the arm through the body tissue during implantation.
28.一种用于植入身体软组织中以保持线的软组织锚固系统，所述软组织锚固系统包括：28. A soft tissue anchoring system for implantation in body soft tissue to hold a wire, the soft tissue anchoring system comprising:
织物体，包括基部和从基部延伸的至少一个臂部；以及a fabric body including a base portion and at least one arm portion extending from the base portion; and
用于使每个臂部以折叠方式朝向基部塌缩使得在使用中身体组织被夹在基部和每个臂部之间的装置；means for collapsing each arm towards the base in a folded manner such that in use body tissue is sandwiched between the base and each arm;
其中，每个臂部包括固定在每个臂部的远离基部的端部处的端盖，其中，每个端盖被配置为接收用于将锚植入身体组织中并且在植入期间拉动臂部通过身体组织的丝线引导构件。Wherein each arm includes an end cap secured at an end of each arm distal from the base, wherein each end cap is configured to receive a wire guide member for implanting the anchor into body tissue and pulling the arm through the body tissue during implantation.
29.根据项28所述的软组织锚固系统，其中，织物体是U形织物体，其包括基部和从基部延伸的至少两个臂部。29. The soft tissue anchoring system of item 28, wherein the fabric body is a U-shaped fabric body comprising a base and at least two arms extending from the base.
30.如项27、28或29所述的软组织锚固系统，其中，每个端盖包括构造成接收丝线引导构件的开口，该开口位于端盖的靠近臂部的端部。30. The soft tissue anchoring system of clause 27, 28 or 29, wherein each end cap includes an opening configured to receive a wire guide member, the opening being located at an end of the end cap proximal to the arm portion.
31.根据项27至30中任一项所描述的软组织锚固系统，其中，每个端盖包括位于端盖的远离臂部的端部处的尖头末端，该尖头末端构造成刺穿身体组织。31. A soft tissue anchoring system as described in any one of items 27 to 30, wherein each end cap includes a pointed tip located at the end of the end cap away from the arm, the pointed tip being configured to pierce body tissue.
32.如项31所述的软组织锚固系统，其中，端盖由弹性材料制成，并且配置为在接收丝线引导构件时从静止构型移动到接合构型；32. The soft tissue anchoring system of item 31, wherein the end cap is made of an elastic material and is configured to move from a rest configuration to an engaged configuration upon receiving the wire guiding member;
其中，在静止构型中，所述尖头末端缩回，使得端盖的远离臂部的端部变钝；并且wherein, in the rest configuration, the pointed tip is retracted such that the end of the end cap distal to the arm is blunt; and
其中，在接合构型中，所述尖头末端延伸，使得端盖的远离臂部的端部是尖头的。Therein, in the engaged configuration, the pointed tip extends such that an end of the end cap remote from the arm is pointed.
33.根据项27至29中任一项所描述的软组织锚固系统，其中，每个端盖包括延伸穿过其的空心导管，其中，空心导管被配置成接收用于将锚植入身体组织中的刺穿丝线引导构件。33. A soft tissue anchoring system as described in any one of items 27 to 29, wherein each end cap includes a hollow conduit extending therethrough, wherein the hollow conduit is configured to receive a piercing wire guide member for implanting the anchor into body tissue.
34.如项33所述的软组织锚固系统，其中，空心导管包括定位成靠近臂部的第一部分和定位成远离臂部的第二部分；34. The soft tissue anchoring system of item 33, wherein the hollow catheter comprises a first portion positioned proximal to the arm and a second portion positioned distal to the arm;
其中，第一部分的半径大于第二部分的半径，并且其中，在第一部分和第二部分之间限定有肩部；并且wherein the radius of the first portion is greater than the radius of the second portion, and wherein a shoulder is defined between the first portion and the second portion; and
其中，空心导管被配置为接收刺穿丝线引导构件，其中，肩部被配置为与刺穿丝线引导构件对接，并且其，中第二部分被配置为允许刺穿丝线引导构件的刺穿末端穿过其中。wherein the hollow catheter is configured to receive a piercing wire guiding member, wherein the shoulder is configured to interface with the piercing wire guiding member, and wherein the second portion is configured to allow a piercing end of the piercing wire guiding member to pass therethrough.
35.根据项27至30、33和34中任一项的软组织锚固系统，其中，端盖的远离臂部的端部是钝的和/或圆形的。35. A soft tissue anchoring system according to any one of items 27 to 30, 33 and 34, wherein the end of the end cap remote from the arm is blunt and/or rounded.
36.根据项27至35中任一项所描述的软组织锚固系统，其中，每个端盖被配置为在接收丝线引导构件时与臂部共线地延伸；并且36. A soft tissue anchoring system as described in any one of clauses 27 to 35, wherein each end cap is configured to extend co-linearly with the arm when receiving the wire guide member; and
其中，每个端盖被配置为当臂部塌缩时，与相应臂部的每个褶层基本位于同一平面。Each end cap is configured to be substantially located in the same plane as each fold of the corresponding arm when the arm is collapsed.
37.根据项26至36中任一项的软组织锚固系统，其中，用于使每个臂部以折叠方式塌缩的所述装置包括穿线通过每个臂部和基部的相应线和/或线的相应部分；37. A soft tissue anchoring system according to any one of clauses 26 to 36, wherein said means for causing each arm to collapse in a folded manner comprises threading a respective wire and/or respective portions of a wire through each arm and the base;
其中，每条线和/或线的部分固定在相应臂部的远离基部的一端；并且wherein each wire and/or portion of a wire is fixed to an end of the corresponding arm remote from the base; and
其中，每条线和/或线的分被配置为当拉力施加到所述线和/或线的部分时，使相应的臂部以折叠的方式朝向基部塌缩。Therein, each wire and/or portion of the wire is configured to cause the corresponding arm portion to collapse towards the base in a folded manner when a tensile force is applied to the wire and/or portion of the wire.
38.根据项37所述的锚固系统，其中，织物体包括嵌入其中的支柱部分，其中，支柱部分在臂部中限定孔，线的相应部分穿线通过该孔。38. An anchoring system according to clause 37, wherein the fabric body includes a strut portion embedded therein, wherein the strut portion defines an aperture in the arm portion through which a corresponding portion of the wire is threaded.
39.根据项26至38中任一项描述的锚固系统，其中，锚是用于植入二尖瓣瓣叶中以保持人造腱索线的瓣叶锚。39. An anchoring system as described in any one of items 26 to 38, wherein the anchor is a leaflet anchor for implantation in a mitral valve leaflet to retain an artificial chordae tendineae.
40.根据项26至39中任一项所描述的锚固系统，其中，基部包括嵌入其中的丝线框架，其中，基部限定了拭子的最宽部分。40. An anchoring system as described in any one of items 26 to 39, wherein the base includes a wire frame embedded therein, wherein the base defines the widest part of the pledget.
41.一种植入如项26至40中任一项所描述的锚固系统的方法，该方法包括：41. A method of implanting an anchoring system as described in any one of items 26 to 40, the method comprising:
使用相应的丝线引导构件推动每个臂部通过身体组织；advancing each arm through body tissue using a corresponding wire guide member;
拉出各个相应的丝线引导构件；以及pulling out each corresponding wire guiding member; and
将每个臂部以折叠方式朝向基部塌缩，使得身体组织被夹在基部和每个臂部之间。Each arm is collapsed toward the base in a folded manner such that body tissue is sandwiched between the base and each arm.
42.一种用于植入身体软组织中以固定人造线的软组织锚固系统，所述锚固系统包括：42. A soft tissue anchoring system for implantation in body soft tissue to fix an artificial thread, the anchoring system comprising:
线；和line; and
管状盖构件；a tubular cover member;
其中，所述线的一端固定到管状盖构件并从其中央部分延伸，使得在使用中所述管状盖构件被配置为，当被植入身体软组织中时并且当线沿远离身体软组织的表面的方向穿过组织时在线的拉力作用下，在与身体软组织的表面平行的平面中延伸；并且wherein one end of the wire is fixed to the tubular cover member and extends from a central portion thereof, such that in use the tubular cover member is configured to extend in a plane parallel to the surface of the soft body tissue under the tension of the wire when implanted in the soft body tissue and when the wire passes through the tissue in a direction away from the surface of the soft body tissue; and
其中，管状盖构件包括开口，该开口构造成接收丝线引导构件，用于在植入期间使管状盖构件穿过身体软组织。Therein, the tubular cover member includes an opening configured to receive a wire guide member for passing the tubular cover member through soft body tissue during implantation.
43.如项42所述的软组织锚固系统，其中，管状盖构件包括外管状构件和内管状构件，其中，外管状构件被配置成接收内管状构件；并且43. The soft tissue anchoring system of clause 42, wherein the tubular cover member comprises an outer tubular member and an inner tubular member, wherein the outer tubular member is configured to receive the inner tubular member; and
其中，内管状构件限定了被配置为接收丝线引导构件的开口。Therein, the inner tubular member defines an opening configured to receive the wire guiding member.
44.如项43所述的软组织锚固系统，其中，内管状构件包括喇叭形入口，所述喇叭形入口限定被构造成接收丝线引导构件的所述开口。44. The soft tissue anchoring system of clause 43, wherein the inner tubular member comprises a flared inlet defining the opening configured to receive the wire guide member.
45.如项44所述的软组织锚固系统，其中，喇叭形入口被配置成与丝线引导构件的对应部分配合。45. The soft tissue anchoring system of item 44, wherein the trumpet-shaped inlet is configured to cooperate with a corresponding portion of the wire guide member.
46.如项43、44或45所述的软组织锚固系统，其中，外管状构件包括侧壁和形成在侧壁中的孔口，其中，孔接收线；并且46. The soft tissue anchoring system of clause 43, 44 or 45, wherein the outer tubular member comprises a sidewall and an aperture formed in the sidewall, wherein the aperture receives the wire; and
其中，所述线的一端部在外管状构件和内管状构件之间固定到管状盖构件。One end of the wire is fixed to the tubular cover member between the outer tubular member and the inner tubular member.
47.根据项42至26中任一项所描述的软组织锚固系统，其中，管状盖构件包括配置成刺穿身体组织的尖头末端，其中，所述尖头末端位于管状盖构件的远离被配置成接收丝线引导构件的开口的端部。47. A soft tissue anchoring system according to any one of items 42 to 26, wherein the tubular cover member includes a pointed end configured to pierce body tissue, wherein the pointed end is located at an end of the tubular cover member away from the opening configured to receive the wire guide member.
48.如项47所述的软组织锚固系统，其中，所述尖头末端包括斜面。48. The soft tissue anchoring system of claim 47, wherein the pointed tip comprises a bevel.
49.根据项42至46中任一项所描述的软组织锚固系统，其中，管状盖构件包括钝的和/或圆形的末端，其中，所述钝的和/或圆形的末端位于管状盖构件的远离被配置为接收丝线引导构件的开口的端部处。49. A soft tissue anchoring system according to any one of items 42 to 46, wherein the tubular cover member includes a blunt and/or rounded end, wherein the blunt and/or rounded end is located at the end of the tubular cover member away from the opening configured to receive the wire guide member.
50.根据项42至49中任一项的软组织锚固系统，包括具有基部和从基部延伸的臂部的织物体；50. A soft tissue anchoring system according to any one of items 42 to 49, comprising a fabric body having a base and an arm extending from the base;
其中，臂部被配置为以折叠方式朝向基部塌缩，使得在使用中身体组织被夹在基部和臂部之间；wherein the arm portion is configured to collapse towards the base portion in a folded manner such that in use body tissue is sandwiched between the base portion and the arm portion;
其中，管状盖构件固定在臂部的远离基部的一端。The tubular cover member is fixed to an end of the arm away from the base.
51.根据项42至50中任一项的软组织锚固系统，其中，臂部被配置为通过穿线通过臂部和基部的线的作用而朝向基部折叠而塌缩；51. A soft tissue anchoring system according to any one of clauses 42 to 50, wherein the arms are configured to collapse toward the base by folding through the action of a wire threaded through the arms and the base;
其中，线被配置为当对线施加拉力时，使臂部以折叠方式朝向基部塌缩。Therein, the wire is configured to cause the arm portion to collapse toward the base in a folded manner when tension is applied to the wire.
52.如项50或51所述的软组织锚固系统，其中，管状盖构件被配置成在织物体的植入和/或回收过程中与臂部共线地延伸；并且52. A soft tissue anchoring system as described in item 50 or 51, wherein the tubular cover member is configured to extend in line with the arm portion during implantation and/or retrieval of the fabric body; and
其中，管状盖构件被配置为当拉力施加到线时平行于臂部的每个褶层的平面延伸。Therein, the tubular cover member is configured to extend parallel to a plane of each pleat of the arm portion when a tensile force is applied to the wire.
53.如项50、51或52所述的软组织锚固系统，其中，织物体为U形织物体，包括基部和从基部延伸的至少两个臂部；53. The soft tissue anchoring system of item 50, 51 or 52, wherein the fabric body is a U-shaped fabric body comprising a base and at least two arms extending from the base;
其中，每个臂部包括固定在臂部的远离基部的一端的管状盖构件。Each arm portion includes a tubular cover member fixed to an end of the arm portion away from the base portion.
54.根据项42至53中的任一项所述的软组织锚固系统，其中，基部限定了U形织物体的最大宽度。54. A soft tissue anchoring system according to any one of items 42 to 53, wherein the base defines a maximum width of the U-shaped fabric body.
55.根据项42至54中任一项的软组织锚固系统，其中，线是人造线。55. A soft tissue anchoring system according to any one of items 42 to 54, wherein the thread is a synthetic thread.
56.根据项42至54中任一项的软组织锚固系统，包括人造线；56. A soft tissue anchoring system according to any one of items 42 to 54, comprising an artificial thread;
其中，所述人造线连接至所述线的远离被固定于中央部分的端部的部分；并且wherein the artificial wire is connected to a portion of the wire remote from an end portion fixed to the central portion; and
其中，人造线被配置为对线施加拉力。Therein, the artificial line is configured to apply tension to the line.
57.根据项42至57中任一项所描述的软组织锚固系统，其中，设置有多个管状盖构件；57. A soft tissue anchoring system according to any one of items 42 to 57, wherein a plurality of tubular cover members are provided;
其中，拉伸线包括多条系绳线，其中，每条系绳线与相应的管状盖构件相关联；并且wherein the tension line comprises a plurality of tether lines, wherein each tether line is associated with a respective tubular cover member; and
其中，每条系绳线都连接到公共的系绳点，其中，所述系绳点被配置为当每条系绳线以远离身体软组织的表面的方向穿过组织时以及当系绳点本身处于拉力之下时，使每条系绳线处于拉力之下。wherein each tether line is connected to a common tether point, wherein the tether point is configured to place each tether line under tension when the tether line passes through the tissue in a direction away from the surface of the soft body tissue and when the tether point itself is under tension.
58.根据项42至57中任一项描述的软组织锚固系统，其中，软组织锚固系统是用于植入心脏瓣膜瓣叶以固定人造腱索线的瓣叶锚固系统。58. A soft tissue anchoring system according to any one of items 42 to 57, wherein the soft tissue anchoring system is a leaflet anchoring system for implanting a heart valve leaflet to fix an artificial chord line.
59.一种用于将软组织锚固系统植入心脏组织中的导管装置，该导管装置包括：59. A catheter device for implanting a soft tissue anchoring system into cardiac tissue, the catheter device comprising:
壳体部分，其中，壳体部分从导管装置的远端沿导管装置的长度向导管装置的近端延伸；以及a housing portion, wherein the housing portion extends from a distal end of the catheter device along the length of the catheter device to a proximal end of the catheter device; and
位于壳体部分内的如项42至58中任一项所描述的软组织锚固系统。A soft tissue anchoring system as described in any one of items 42 to 58 located within a shell portion.
60.如项59所述的导管装置，其中，软组织锚固系统包括多个管状盖构件；导管装置包括：60. The catheter device of claim 59, wherein the soft tissue anchoring system comprises a plurality of tubular cover members; the catheter device comprising:
部署系统，其被配置为将各个管状盖构件同时植入心脏组织中；a deployment system configured to simultaneously implant the individual tubular cover members into cardiac tissue;
其中，部署系统包括多个丝线引导构件，其中，每个丝线引导构件包括位于丝线引导构件的远端处并配置为接合相应的管状盖构件的导引部分；并且wherein the deployment system comprises a plurality of wire guide members, wherein each wire guide member comprises a guide portion located at a distal end of the wire guide member and configured to engage a corresponding tubular cover member; and
其中，部署系统被配置为在植入管状盖构件期间保持所述多个丝线引导构件的导引部分之间的共面对齐。Therein, the deployment system is configured to maintain coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the tubular cover member.
61.根据项60所述的导管装置，其中，每个丝线引导构件包括凸起部分；并且61. The catheter device of clause 60, wherein each wire guiding member comprises a raised portion; and
其中，每个丝线引导构件能够在第一构型和第二构型之间移动，其中，在第一构型中，凸起部分被配置为接合第一障碍物，该第一障碍物被配置为限制丝线引导构件在近端方向上的平移，并且其中，在第二构型中，丝线引导构件被配置为接合相应的管状盖构件。Wherein, each wire guide member is capable of moving between a first configuration and a second configuration, wherein, in the first configuration, the raised portion is configured to engage a first obstacle configured to limit translation of the wire guide member in a proximal direction, and wherein, in the second configuration, the wire guide member is configured to engage a corresponding tubular cover member.
62.如项61所述的导管装置，其中，所述第一障碍物是位于壳体部分的近端部分中的抵接部分。62. A catheter device as described in claim 61, wherein the first obstacle is an abutment portion located in the proximal portion of the shell portion.
63.如项61或62所述的导管装置，其中，在第二构型中，凸起部分被配置成抵接管状盖构件的互补部分。63. The catheter device of claim 61 or 62, wherein, in the second configuration, the raised portion is configured to abut a complementary portion of the tubular cover member.
64.如项61、62或63所述的导管装置，其中，部署系统包括弹簧装置，该弹簧装置被配置成将每个丝线引导构件偏压到第一构型中。64. The catheter device of clause 61, 62 or 63, wherein the deployment system comprises a spring device configured to bias each wire guide member into the first configuration.
65.如项59所述的导管装置，包括：65. The catheter device of claim 59, comprising:
与开口接合的丝线引导构件。A wire guiding member engages the opening.
66.根据项65所述的导管装置，其中，所述丝线引导构件包括肩部；以及66. The catheter device of clause 65, wherein the wire guiding member comprises a shoulder; and
其中，壳体部分包括止动部分，该止动部分被配置为与肩部配合，从而限制丝线引导构件在壳体部分中的远端平移。Therein, the housing portion comprises a stop portion configured to cooperate with the shoulder portion to limit distal translation of the wire guiding member in the housing portion.
67.根据项59至66中任一项所描述的导管装置，包括：67. A catheter device according to any one of items 59 to 66, comprising:
用于放置在心脏瓣膜的瓣叶中的瓣叶锚，其中，该瓣叶锚是前述权利要求中任一项的软组织锚，其中，瓣叶锚布置成与人造线联接；以及A leaflet anchor for placement in a leaflet of a heart valve, wherein the leaflet anchor is a soft tissue anchor according to any one of the preceding claims, wherein the leaflet anchor is arranged to couple with an artificial thread; and
瓣叶锚部署机构，用于部署瓣叶锚，将其附着到心脏的瓣叶上。The leaflet anchor deployment mechanism is used to deploy the leaflet anchor to attach it to the leaflet of the heart.
68.如项67所述的导管装置，包括：68. The catheter device of claim 67, comprising:
用于抓握心脏瓣膜的瓣叶的机械夹持装置；以及Mechanical gripping devices for grasping leaflets of heart valves; and
瓣叶锚管，用于在瓣叶锚部署到身体组织之前容纳瓣叶锚；a leaflet anchor tube for receiving the leaflet anchor prior to deployment of the leaflet anchor into body tissue;
其中，夹持装置和瓣叶锚被布置成使得在使用中，当夹持装置抓住瓣叶时，瓣叶锚固系统可以被推出瓣叶锚管以刺穿瓣叶并部署锚，使得其被植入瓣叶中。Therein, the clamping device and the leaflet anchor are arranged so that in use, when the clamping device grasps the leaflet, the leaflet anchoring system can be pushed out of the leaflet anchor tube to pierce the leaflet and deploy the anchor so that it is implanted in the leaflet.
69.如项68所述的导管装置，其中，夹持装置包括夹持臂，其可旋转地联接到导管装置的主体，使得夹持臂被配置为相对于导管装置旋转，以使夹持臂的外端部移离导管装置的主体。69. A catheter device as described in claim 68, wherein the clamping device includes a clamping arm which is rotatably connected to the body of the catheter device, so that the clamping arm is configured to rotate relative to the catheter device to move the outer end of the clamping arm away from the body of the catheter device.
70.如项69所述的导管装置，其中，夹持臂包括形成于夹持臂基部中的狭槽，并且其中，夹持臂通过所述狭槽可旋转地联接至主体，使得夹持臂被配置为远离导管装置的主体平移。70. A catheter device as described in claim 69, wherein the clamp arm includes a narrow slot formed in the base of the clamp arm, and wherein the clamp arm is rotatably connected to the body via the narrow slot so that the clamp arm is configured to translate away from the body of the catheter device.
71.一种植入如项42至58中任一项所描述的软组织锚固系统的方法，该方法包括：71. A method of implanting a soft tissue anchoring system as described in any one of items 42 to 58, the method comprising:
使用丝线引导构件接合管状盖构件；engaging the tubular cover member using the wire guide member;
使用丝线引导构件推动管状盖构件穿过身体组织；advancing the tubular cover member through body tissue using the wire guide member;
拉出丝线引导构件；以及pulling out the wire guiding member; and
当线沿远离组织的表面的方向穿过组织时对线施加拉力，使得管状盖构件靠着身体软组织。Tension is applied to the wire as it passes through the tissue in a direction away from the surface of the tissue, causing the tubular cover member to rest against the soft body tissue.
72.一种制造如项42至58中任一项所述的软组织锚固系统的方法，该方法包括：72. A method of manufacturing a soft tissue anchoring system as described in any one of items 42 to 58, the method comprising:
制造管状盖构件；以及manufacturing a tubular cover member; and
将线固定到管状盖构件上，线从其中央部分延伸。A wire is secured to the tubular cover member, the wire extending from a central portion thereof.
73.一种用于植入身体软组织中以保持人造线的软组织锚固系统，所述锚包括：73. A soft tissue anchor system for implantation in body soft tissue to hold an artificial thread, the anchor comprising:
U形织物体，其包括基部和从基部延伸的至少两个臂部；a U-shaped fabric body comprising a base and at least two arms extending from the base;
其中，每个臂部被配置为以折叠方式朝向基部塌缩，使得在使用中身体组织被夹在基部和每个臂部之间。Therein, each arm is configured to collapse towards the base in a folded manner such that in use body tissue is sandwiched between the base and each arm.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US63/316,062 | 2022-03-03 | ||
| US202363440766P | 2023-01-24 | 2023-01-24 | |
| US63/440,766 | 2023-01-24 | ||
| PCT/EP2023/055514WO2023166217A1 (en) | 2022-03-03 | 2023-03-03 | Soft tissue anchor system for heart repair |
| Publication Number | Publication Date |
|---|---|
| CN118785856Atrue CN118785856A (en) | 2024-10-15 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202380024098.1APendingCN118785857A (en) | 2022-03-03 | 2023-03-03 | Soft tissue anchoring system for cardiac repair |
| CN202380024061.9APendingCN118785855A (en) | 2022-03-03 | 2023-03-03 | Soft tissue anchoring system for cardiac repair |
| CN202380024069.5APendingCN118785856A (en) | 2022-03-03 | 2023-03-03 | Soft tissue anchoring system for cardiac repair |
| CN202380024076.5APendingCN118946317A (en) | 2022-03-03 | 2023-03-03 | Soft tissue anchoring system for cardiac repair |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202380024098.1APendingCN118785857A (en) | 2022-03-03 | 2023-03-03 | Soft tissue anchoring system for cardiac repair |
| CN202380024061.9APendingCN118785855A (en) | 2022-03-03 | 2023-03-03 | Soft tissue anchoring system for cardiac repair |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202380024076.5APendingCN118946317A (en) | 2022-03-03 | 2023-03-03 | Soft tissue anchoring system for cardiac repair |
| Country | Link |
|---|---|
| CN (4) | CN118785857A (en) |
| Publication number | Publication date |
|---|---|
| CN118785855A (en) | 2024-10-15 |
| CN118785857A (en) | 2024-10-15 |
| CN118946317A (en) | 2024-11-12 |
| Publication | Publication Date | Title |
|---|---|---|
| US20220192656A1 (en) | Device for heart repair | |
| AU2019386315B2 (en) | Device for heart repair | |
| US20240023951A1 (en) | Device for heart repair | |
| US20250177137A1 (en) | Soft tissue anchor system for heart repair | |
| CN118785856A (en) | Soft tissue anchoring system for cardiac repair | |
| GB2581545A (en) | Device for heart repair | |
| GB2579420A (en) | Device for heart repair | |
| GB2580994A (en) | Device for heart repair | |
| GB2579387A (en) | Device for heart repair | |
| GB2634009A (en) | Device for heart repair | |
| GB2581863A (en) | Device for heart repair |
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |