JPWO2019177909A5 - - Google Patents

Description

(Mutual reference of related applications)
This application applies to 35 U.S. of US Provisional Application No. 62 / 641,612 filed on March 12, 2018. S. C. It asserts the benefits under Section 119 (e), all of which are incorporated herein by reference for all purposes. This application is also a partial continuation of U.S. Patent Application No. 15 / 858,671 filed December 29, 2017, which is U.S. Patent Application No. 15 / filed June 29, 2017. Claims priority over US Provisional Application No. 62 / 441,031 filed on December 30, 2016, which is a partial continuation application of US Pat. No. 638,176, now US Pat. No. 9,877,833. All of these applications are incorporated herein by reference for all purposes. All applications with foreign or domestic priority claims specified in the application datasheets submitted with this application are incorporated herein by reference under Section 37 CFR 1.57.

The present disclosure relates to mitral valve repair or mitral valve replacement, and more generally, mitral valve chordae tendineae remodeling and repair to restore proper functioning of the mitral valve from a condition of mitral valve regurgitation. And / or the method and method and device for replacement.

The heart has four heart valves that allow blood to pass through the four chambers of the heart in one direction. The four valves are the tricuspid valve, the mitral valve, the lung valve and the aortic valve. The four rooms are the left and right ventricles (upper chamber) and the left and right ventricles (lower chamber).

The mitral valve is formed by two leaflets called the anterior and posterior leaflets, which open and close according to the pressure applied to the valve leaflets by the pumping of the heart. With regard to the mitral valve, some problems occur or can occur. One such problem is mitral regurgitation (MR), which can lead to leakage of the mitral valve due to improper closure of the mitral valve leaflet. Severe mitral regurgitation adversely affects cardiac function and can impair a patient's quality of life and longevity.

Several techniques have been developed to correct mitral regurgitation. These include heart transplantation, valve replacement or valve repair, chordae tendineae shortening or chordae tendineae replacement, and mitral annuloplasty, also known as annuloplasty, depending on the disease and the underlying etiology.

Certain surgical and trans-apical approaches have been proposed in connection with chordae tendineae replacement or repair. However, despite these efforts, there remains a need for a transvascular approach for chordae tendineae replacement or chordae tendineae repair in order to reduce or eliminate MR.

Aspects of the invention include a method of transplanting a transvascular artificial tendon cord, the method comprising a step of allowing the catheter to enter the left atrium and into the left ventricle through the mitral valve and from the catheter to the left ventricle. A step of deploying a ventricular anchor in the wall of the heart, leaving a ventricular suture that is attached to the ventricular anchor and extends proximally through the catheter, and a valve through the catheter through the upper surface of the mitral leaflet from the atrial side. The step of advancing the apex anchor and placing the apex anchor with respect to the lower (ventricular) side of the apex with a leaflet suture extending proximally through the apex and ventricular suture of the apex suture from the apex of the apex. Includes a step of fixing to the thread and limiting the range of movement of the leaflet toward the left ventricle.

Another aspect of the present disclosure comprises a catheter having proximal and distal ends, a valvular anchor located at the distal end of the catheter, and a needle that can be advanced through the valvular anchor, wherein the needle is pre-loaded. A valvular anchor deployment system that is loaded and releasably carries a radially expandable valvular anchor with sutures extending proximally through the catheter.

According to another aspect of the present invention, a method for transplanting a transvascular artificial chordae tendineae is provided. This method involves the step of inserting the catheter into the left atrium and entering the left ventricle through the mitral valve, and deploying the ventricular anchor from the catheter into the wall of the left ventricle, which is attached to the ventricular anchor to attach the catheter. With the step of leaving a ventricular suture extending proximally through the ventricle, and fixing the leaflet anchor catheter to the mitral valve leaflet from the atrial side and fixing the valve leaflet anchor catheter to the valve leaflet, the catheter is passed through the mitral valve leaflet. Advance the valve leaflet anchor from, secure the mitral valve leaflet to the valve leaflet suture extending proximally through the catheter, and secure the valve leaflet suture to the ventricular suture to the left atrioventricular direction of the valve leaflet. Includes steps that limit the range of movement.

The step of advancing the leaflet anchor from the catheter through the mitral valve leaflet to secure the mitral valve leaflet can include advancing the needle preloaded with the valve leaflet anchor through the upper surface of the mitral valve leaflet. The step of fixing the leaflet anchor catheter to the mitral valve leaflet can include the use of a leaflet connector. The valve leaflet connector may include a spiral anchor or tissue hook.

According to another aspect of the present invention, there is provided a method of fixing the valve leaflet anchor to the mitral valve leaflet. In this method, the step of advancing the catheter into the left atrium, the step of fixing the leaflet connector connected to the catheter from the atrial side of the valve leaflet to the mitral valve leaflet from the atrial side, and the step of fixing the valve leaflet connector to the mitral valve leaflet are performed. After fixation to the valve leaflet, the step includes advancing the valve leaflet anchor through the mitral valve leaflet to secure the mitral valve leaflet to the valve leaflet suture.

The step of advancing the valve leaflet anchor through the mitral valve leaflet to secure the mitral valve leaflet to the leaflet suture may include advancing the needle preloaded with the valve leaflet anchor from the atrial side through the mitral valve leaflet. can. The needle can also be advanced from the valve leaflet connector. The valve leaflet connector may include a spiral anchor.

According to another aspect of the invention, a valve leaflet anchor deployment system is provided. The system includes a catheter with proximal and distal ends, a valvular connector located at the distal end of the catheter, and a needle that can be advanced through the valvular connector, the needle pre-existing there. Includes a radially expandable valvular anchor with sutures loaded and extending proximally through the catheter. The valve leaflet connector may include a spiral anchor.

According to another aspect of the invention, a new chordae tendineae deployment system is provided. The system has a catheter with proximal and distal ends, a spiral ventricular anchor subassembly that extends proximally through the catheter, and a spiral ventricular anchor subassembly that extends through the catheter, and a leaflet anchor deployment that extends through the catheter. A system with a subassembly, the valvular anchor deployment subassembly has a valvular anchor that expands radially within it and a valvular suture that extends proximally through the catheter.

Radially expandable flap anchors can include pledgets. This pledget can be transformed from an elongated strip shape to a radially expanding axially retracted shape by the proximal contraction of the suture. Radially expandable leaflet anchors can include leaflet sutures placed between two sheets of material. Radially expandable valvular anchors can be carried within a needle with a sharp tip for piercing the valvular tip. The valvular anchor deployment subassembly can include an elongated tube with a distal end and a central lumen, and a valvular connector on the distal end. The valvular connector can include a spiral valvular anchor. The needle can move axially with respect to the spiral valve leaflet anchor. The system can further advance through a catheter and include a suture lock subassembly configured to connect the ventricular suture to the leaflet suture.

According to another aspect of the invention, a valve leaflet anchor delivery subsystem is provided. This subsystem consists of an elongated flexible tubular body with proximal, distal and central lumens, an axially movable deployable needle through the central lumen, and a valve carried within the deployable needle. It includes a cusp anchor and a valvular connector carried by the distal end of the tubular body. The valve leaflet anchor can include a spiral element. The unfolding needle may be axially extendable through a helical element.

According to another aspect of the invention, a tissue anchor is provided. Tissue anchors are hubs, sutures extending proximally from the hub, spiral anchors extending distally from the hub, and core wires that extend concentrically over the distal end of the spiral anchor through the spiral anchor. And include.

Tissue anchors can further include suture anchor guides that extend proximally from the hub. The tissue anchor can further include a tubular sleeve having a length of about 10 cm or less extending proximally from the hub. Tissue anchors can further include radiodensity markers carried by the sleeve. Tissue anchors can further include radiation opaque markers that are axially mobile and movably carried by the core wire. Tissue anchors can further include springs carried by core wires. The tissue anchor further includes a tissue perforation point on the distal end of the spiral anchor and a spine on the spiral anchor configured to resist rotation of the spiral anchor from engagement with the tissue. May be good.

According to another aspect of the invention, a tissue anchor with a dynamic depth indicator is provided. This tissue anchor is distant from the hub, the tissue anchor extending distally from the hub, the core wire extending distally from the hub, the radiation opaque marker movably carried by the hub, and the radiation opaque marker. The radiation impermeable marker, including a spring urging in the orientation direction, advances proximally to the tissue anchor in response to the tissue anchor advancing into the tissue.

According to another aspect of the invention, an intravascular suture lock is provided. The suture lock responds to the rotation of the body with the suture path extending through it, the movable wall in the housing to reduce the cross-sectional dimension of the suture path, the rotatable joint on the housing, and the joint. Includes a drive mechanism for advancing the movable wall.

The suture lock can further include a friction-enhancing surface exposed in the suture path. The friction-enhancing surface may be on a movable wall. The suture lock has an angled surface and can include a push wedge that is axially movable within the housing. The rotation of the joint can advance the movable wall laterally and axially advance the push wedge that changes the cross-sectional dimensions of the suture path. The movable wall can include a suture gripping surface on the first side and an inclined surface on the second side, and the inclined surface is configured to be in sliding contact with an angled surface on the push wedge.

The aforementioned features and other features of the present disclosure, together with the accompanying drawings, will become more fully apparent from the following description and the appended claims. It should be understood that these figures depict only a few embodiments in accordance with the disclosure and are not considered to be limiting in scope.

FIG. 1 shows the placement of ventricular anchors through a transcranial approach to the mitral valve. FIG. 2A shows a ventricular anchor. FIG. 2B shows a ventricular anchor. FIG. 2C is a perspective view of the ventricular anchor on the distal end of the ventricular anchor deployment tool. FIG. 2D is a perspective view of the proximal end of the ventricular anchor deployment tool. FIG. 2E is a partially exploded perspective view of the ventricular anchor and the distal end of the ventricular anchor deployment tool. FIG. 3 shows the deployed end of a catheter placed to connect with the mitral valve apex. FIG. 4 shows a valve leaflet captured by a spiral valve leaflet anchor and a needle that crosses the valve leaflet from the atrium to the ventricle. FIG. 5 shows a prejet-type valve leaflet anchor that extends from the needle into the ventricle. FIG. 6A shows proximal traction on the leaflet suture to fold the prejet with respect to the ventricular side of the leaflet. FIG. 6B shows the details of the prejet type valve leaflet anchor. FIG. 6C shows the details of the Pledget type valve leaflet anchor. FIG. 6D shows the details of the Pledget type valve leaflet anchor. FIG. 7 shows the deployed valve leaflet anchor and suture, as well as the deployed ventricular anchor and suture ready for tension and attachment of the suture lock. FIG. 8 shows a perspective view of the distal end of the leaflet anchor delivery subsystem. FIG. 9 shows a perspective view of the proximal end of the leaflet anchor delivery subsystem. FIG. 10 shows an exploded view of the distal end of the leaflet anchor delivery subsystem. FIG. 11 shows how the suture lock is advanced beyond the valve leaflet anchor suture and the ventricular anchor suture through the suture lock delivery subsystem to connect the valve leaflet anchor to the ventricular anchor. FIG. 12 shows a suture lock that is in the locked position after the tension has been adjusted and the suture end has been cut. FIG. 13 shows a perspective view of the distal end of the suture lock delivery subsystem. FIG. 14 shows a perspective view of the proximal end of the suture lock delivery subsystem. FIG. 15 shows a partially exploded view of the distal end of the suture lock delivery subsystem. FIG. 16 shows a perspective view of the distal end of the suture cutting assembly. FIG. 17 shows a side view of the cutting assembly portion of the suture lock delivery subsystem in a configuration in which the cutting head has not yet advanced to hold the suture before it is cut. FIG. 18 shows a side view of the cutting assembly portion of the suture lock delivery subsystem in a configuration in which the cutting head is advanced to cut the suture. FIG. 19 shows a suture lock and a side view of the distal end of a torque drive configured to be coupled to the suture lock. FIG. 20 shows a view of the proximal end of the suture lock. FIG. 21 shows a view of the distal end of the suture lock.

US Patent Application 15 / 858,671 filed December 29, 2017, which is incorporated herein by reference in its entirety, discloses a system and method for transvascular artificial chordae tendineae transplantation. One embodiment is to allow the catheter to enter the left atrium, through the mitral valve into the left ventricle, deploy the ventricular anchor from the catheter, place it in the wall of the left ventricle, and attach to the ventricular anchor. A leaflet anchor is inserted into the mitral valve leaflet to secure the mitral valve leaflet to the proximal valve leaflet suture through the catheter, leaving a ventricular suture extending proximally through the catheter. Extends to the superior surface of the leaflet and secures the leaflet suture to the ventricular suture, limiting the range of movement of the leaflet toward the left atrial. Specific embodiments are further developed herein.

The approach to the mitral valve can be achieved by a standard transseptal approach that provides access to the left atrium. This access allows the first step to secure the mitral valve apex catheter to the mitral valve apex at a position determined to best compensate for regurgitation. Examining the surface of the leaflet from the surface of the superior atrium can provide advantageous and immediate feedback regarding the optimal position for adding the mitral valve chordae tendineae. In another embodiment of the invention, the ventricular anchor is first deployed, followed by the valve leaflet anchor.

Referring to FIG. 1, a ventricular anchor such as a spiral anchor 32 is deployed near the apex 20 of the left ventricle 24. In the figure below, the spiral anchor 32 is located near the apex 20, but the anchor 32 can also be attached in a position offset from the thin tissue of the apex, or between two papillary muscles, etc. It can also be implanted in the generally thicker adjacent wall of the ventricle. This allows the transplanted chordae tendineae construct (suture, any new papillary muscle, and / or spiral anchor) to be substantially parallel or concentric with the original path of the original chordae tendineae. Is aligned. In certain embodiments, the transplanted chordae tendineae construct is 5 degrees, 10 degrees, or 15 degrees from a line parallel to the original path of the original chordae tendineae and / or the path adjacent to the path of the original chordae tendineae. Aligned along the vertical axis within degrees. Further, while the spiral anchor is illustrated, the anchor can have different structures for engaging the tissue of the heart and therefore various known piercings, hooks or or for engaging the tissue. Other tissue anchor structures can be used in place of the helical structure, which includes a radially expandable structure.

Referring to FIGS. 2A and 2B, one embodiment of a tissue anchor suitable for use as a ventricular anchor according to the present invention is shown. The anchor assembly 50 is described primarily in the context of chordae tendineae repair applications of the present application, but anchors can be utilized in any of a wide range of other applications where soft tissue or bone anchors may be desired.

The anchor assembly 50 generally includes a coil 54 which may include any of a variety of materials such as stainless steel or nitinol. The coil 54 extends spirally between the proximal end 56 and the distal end 58. The distal end 58 comprises a sharp tip 59 and also carries a retaining spine 61 configured to resist reverse rotation of the coil and detachment from tissue. The proximal end 56 of the coil 54 is carried by a hub 57, which is discussed in more detail below (either attached to the hub or formed integrally with the hub).

Extending distally from the hub 57 and into the coil 54 is an elongated core wire 62 having a distal end 64 that is pierced by sharp tissue. The distal end 64 is located distal to the distal end 58 of the coil 54. This allows the sharp distal end 64 to perforate the tissue to embed the coil 54 in the target tissue at the time of contact and before the coil 54 begins to rotate. Engaging the tip 64 prior to the rotation of the anchor stabilizes the anchor against lateral movement and places the anchor 50 in one place with respect to the tissue, thereby as understood by those skilled in the art. In addition, the coil 54 can be rotated to engage the tissue without the anchor "shaking" from the desired target site. The proximal end of the core wire 62 is hubbed in a variety of ways, including, for example, soldering, brazing, adhesive, and / or mechanical interference means such as inserting into the sidewall or other surface opening of the hub 57. Can be attached to.

The radiation opaque depth marker 66 comprises an opening 68 and is carried axially movably on the core wire 62. Distal stops 70, such as radially outwardly extending protrusions or ring-shaped protrusions, are carried by the core wire 62, spaced proximally from the sharp distal end 64, with the marker 66 being the distal tip. A core wire lead segment 72 is provided distal to the stop 70 so as not to impair the tissue fixation function of 64. The stop 70 functions to limit the distal movement of the marker 66. The marker 66 may have an annular structure, such as a circular disc, with a central opening for receiving the core wire 62.

The coil spring 71 is concentrically carried on the core wire 62 and urges the radiodensity marker 66 in the distal direction. Therefore, the radiodensity marker 66 is held in position with respect to the proximal side surface of the stop 70. At the time of use, the marker 66 rides on the surface of the tissue at the target attachment site. As the spiral coil anchor 54 rotates and advances distally into the tissue, the marker 66 rides proximally on the core wire 62 with the tissue surface, the tissue anchor is completely embedded and the marker 66 is proximal to the hub. Compress the coil spring 71 until it recedes to the side. It completes the progress of the coil into the tissue and the implantation of the coil 54 into the target tissue by observing the varying distance between the marker 66 and a reference such as a hub 57 or other radiodensity marker. Enables fluoroscopic visualization of the end point fitted in.

The hub 57 includes a proximal connector for engagement with a rotary drive, as discussed elsewhere herein. In one embodiment, the connector comprises an opening, such as a hexagonal opening, for removable engagement with a complementary surface structure on the distal end of the drive. The suture 74 is secured to the anchor assembly 50, for example, the hub 57, the coil 54 or the core wire 62. In the illustrated embodiment, the suture 74 is attached to a cross pin 76 that is inserted across the central hub lumen through one or two openings in the side wall of the hub. The suture can additionally carry one or more radiodensity markers 82 away from the hub 57 and laterally through the proximal connector of the rotational drive and the central lumen. Can be extended.

A suture lock guide, such as the tubular sleeve 78, extends at least about 2 mm or 4 mm or 8 mm proximal to the hub 57, but is generally no more than about 5 cm or 2 cm depending on the desired performance. The guide sleeve 78 may contain a flexible material such as ePTFE. Preferably, the radiation impermeable marker band 80 is carried by the proximal end of the sleeve 78, placed axially away from the marker 82 on the suture 74 and advanced distally on the suture 74. Facilitates fluoroscopic visualization of suture locks. The marker band 80 may be located between the inner and outer layers of the ePTFE sleeve by placing the band on the sleeve and flipping the sleeve over it to wrap the ring.

After withdrawal from the deployment catheter, the suture lock guide extends proximally from the sleeve or hub as shown to maintain the orientation of the suture lock and is received into the lumen within the suture lock. It may contain any of various structures such as alignment pins. Suture tension is optimized while the suture lock is held in place by the deployable catheter, so any change in suture lock orientation after release from the catheter affects suture apical tension. Or can potentially have a negative impact on the therapeutic value of the implant. The suture lock guide helps maintain a constant maximum distance between the ventricular anchor and the leaflet anchor both before and after deployment from the catheter. In this way, the maximum tension of the leaflet suture (in systole) does not change either before or after withdrawal of the catheter after the suture lock is locked.

The spiral anchor assembly 50 can be delivered by the ventricular anchor delivery subsystem 300. 2C-2E show various diagrams of the ventricular anchor delivery subsystem 300 and its components. FIG. 2C shows a perspective view of the distal end of the subsystem 300. FIG. 2D shows a perspective view of the proximal end of the subsystem 300. FIG. 2E shows a partially exploded view of the distal end of the subsystem 300.

The subsystem 300 can be delivered through the delivery catheter 100. The delivery catheter 100 can access the left atrium via conventional techniques such as atrial transseptal puncture. The delivery catheter 100 can be maintained in a substantially constant position throughout the procedure while various subsystems are placed and removed from the delivery catheter 100. For example, the distal end of the delivery catheter 100 is located in the left atrium. In other embodiments, the distal end of the delivery catheter 100 may be placed in the left ventricle throughout the procedure.

As shown in FIGS. 2C-2E, the ventricular anchor delivery subsystem 300 may include an outer sheath 304, a drive unit (including shaft 307 and head 306), anchor hub 308, and anchor 302. The anchor may be a spiral anchor 302, and the drive head 306 can be configured to rotate the spiral anchor 302. The spiral anchor 302 can include an inner diameter configured to be received on the outer diameter of the anchor hub 308. The spiral anchor 302 may be securely fastened to the anchor hub 308 by a tight fit or other frictional engagement, soldering or other known mounting technique. The anchor hub 308 may remain embedded with the spiral anchor 302.

The anchor hub 308 may include a lumen substantially along the central axis of the anchor hub 308 to receive the suture 74 (FIG. 2A) and attach the suture 74 to the spiral anchor 302. can. In some embodiments, the suture 74 comprises an adhesive element (eg, nodule or washer) having a diameter sized to prevent the suture 74 from being pulled proximally through the lumen of the anchor hub 308. You may. For example, the suture 74 can be tied to the distal side of the lumen. In some embodiments, the suture 74 can be tied to the anchor hub 308 (eg, through the lumen and wrapped around an outer surface or a structure such as a crosspin 76 as shown in FIG. 2B. Rare and tied to itself).

The spiral anchor 302 can include a distal portion of the winding and a proximal portion of the winding. The proximal portion of the winding may be narrower than the distal portion of the winding and may be configured to secure the spiral anchor 302 to the anchor hub 308. The distal portion of the winding may be placed more spaced than the proximal portion of the winding and may be configured for insertion into ventricular tissue. The anchor hub 308 is configured to contact the spiral anchor 302 and / or prevent the spiral anchor 302 from traveling proximally beyond the proximal end of the anchor hub 308. It can have a cross section with an enlarged position. Other spiral anchors described elsewhere herein may be configured for use with the ventricular anchor delivery subsystem 300 described herein as well.

The proximal surface of the spiral anchor 308 can include a recess for receiving the extension portion 306'of the drive head 306. The recess may be non-circular (eg, a polygon such as a rectangle or a hexagon) so that it is configured to transmit torque from the drive to the anchor hub 308 as the drive rotates. The recess may be located around the central lumen of the anchor hub 308.

In other embodiments, the anchor hub 308 can include an extension portion and the drive unit 306 can have opposing recesses. The drive head 306 may be substantially cylindrical with a distally facing post or opening having a complementary configuration for rotational engagement with the corresponding component on the anchor. The drive head 306 may be fixedly connected to the drive shaft 307. The drive unit may include a central lumen through the drive head 306 and the drive shaft 307 configured to receive the suture 74. The central lumen of the drive may be configured to align with the central lumen of the anchor hub 308. The drive shaft 307 may be received within the guide shaft 305. The diameter of the drive head 306 may be larger than the inner diameter of the guide shaft 305. The outer sheath 304, along with the drive head 306, the anchor hub 308, and the spiral anchor 302, can be sized to accommodate the guide shaft 305.

The outer sheath 304 can be delivered via the delivery catheter 100 to the left ventricle and proximal to the ventricular attachment site. In some embodiments, the outer sheath 304 can be delivered without a delivery catheter. In some embodiments, the outer sheath 304 is placed proximal to the ventricular attachment site and then pushed distally through the outer sheath 304, or the outer sheath 304 retracts proximally and is a spiral anchor. The spiral anchor 302 may be hidden within the outer sheath 304 until the 302 is exposed. The spiral anchor 302 can be brought into contact with the ventricular tissue. Rotation of the drive shaft 307 causes the drive head 306, anchor hub 308, and spiral anchor 302 to rotate, thereby screwing the ventricular anchor 302 into the ventricular tissue. The rotation of the drive unit 309 can cause the drive unit 309, the anchor hub 308, and the spiral screw 302 to be axially advanced distally to the outer sheath 304.

The drive shaft 307 can be manually rotated by the user using the drive handle 312, as shown in FIG. 2D. As shown in FIG. 2D, the proximal end of the ventricular anchor delivery subsystem 300 can include first and second hemostatic valves 314, 316. The first hemostatic valve 314 may be located distal to the drive handle 312 and may provide access to the guide shaft 305. The second hemostatic valve 316 may be located proximal to the drive handle 312 and may provide access to the central lumen of the drive. The ventricular anchor suture (not shown) may extend through the second hemostatic valve 316.

In some embodiments, the insertion portion 306'of the drive head 306 and the recess of the anchor hub 308 may have a frictional engagement that temporarily holds the two components together. The frictional engagement can be released upon insertion of the spiral anchor 302 by reaction forces from the ventricular tissue during proximal retraction of the drive. In some embodiments, the proximal tension on the suture 74 can provide an engaging force between the proximal hub 308 and the drive head 306, which is released upon retraction of the drive unit 309. Can be done. The drive head 306 may be retracted proximally into the outer sheath 304 before the outer sheath 304 is drawn into the delivery catheter 100.

The non-embedded component of the ventricular anchor delivery subsystem 300 can be removed from the delivery catheter 100 and subsequent subsystems can be placed in the delivery catheter 100 to complete the implantation of the new chordae tendineae. In a modified embodiment, subsequent subsystems such as the ventricular anchor delivery subsystem 300 and the valve leaflet anchor delivery subsystem 330 may be simultaneously placed within the delivery catheter 100, in some arrangements the tissue and valve leaflets. Both anchors can be preloaded into the delivery catheter. In an alternative embodiment, the transplantation of ventricular anchors may be performed in a different order (eg, after transplantation of the leaflet anchors). The ventricular anchor delivery component may be retracted proximally beyond the proximal end of the suture 74 that remains extended through the delivery catheter 100 to the ventricular anchor 302.

FIGS. 3-6 show the deployment of the leaflet anchor. Referring to FIG. 3, the ventricular anchor 32 is unfolded and connected to the catheter 100 by the ventricular anchor suture 74 and the ventricular anchor subsystem is removed. The valve leaflet anchor is carried into the needle 338 directed at the target site on the atrial side of the valve leaflet. The needle 338 is axially carried back and forth within the catheter 100, such as within a tubular sleeve 332 that can be advanced through the catheter 100. Additional details of the needle and needle drive will be discussed below.

As shown in FIG. 3, in the arrangement shown in the figure, the needle can pass through the leaflet from the atrium to the ventricle and advance the preloaded suture into the ventricle. The suture can then be used to fold the prejet against the ventricular side of the valve leaflet and secure the suture to the valve leaflet as shown in FIG. Therefore, the prejet forms a radially expandable valve leaflet anchor. In certain embodiments, other forms of radially expandable valvular anchors can be used.

The leaflet anchors and sutures can then be used in combination with ventricular anchors, sutures and suture locks to effectively create new mitral chordae tendineae as shown in FIG. As mentioned above, the leaflet anchors and sutures are included in US Patent Application No. 15 / 858,671 (which is incorporated herein by reference in its entirety) and the ventricular anchors, sutures and sutures disclosed therein. It can be used in combination with the systems and methods for transvascular artificial chordae tendineae disclosed in various embodiments of thread lock.

Preferably, the valvular anchor deployment subassembly is provided with a temporary anchor for capturing and stabilizing the valvular tip, while the needle tip 338 advances through it on the target side. As shown in FIGS. 3 and 4, the distal end 400 of the delivery tube 332 or other system component has a temporary tissue anchor, such as a spiral tissue anchor 402. The anchor 402 does not have a distal spine because the temporary anchor 402 is intended to engage only temporarily with the leaflet, except that it is similar to the leaflet anchor 54. It can be anything. Thus, the anchor 402 includes a helical element 406 ending at the distal tip 408.

In use, the distal tip 408 is placed at the target site on the valve leaflet surface, and the helical element 406 rotates about an axis to engage and penetrate the valve leaflet. The needle tip 338 may optionally engage the valve leaflet prior to rotation of the helical element 406, in response to rotation in a manner similar to that described in connection with the ventricular anchor and FIGS. 2A and 2B. It may be used to stabilize the anchor moving against the target site.

After the spiral element 406 captures the leaflet from the atrial side and engages to secure the leaflet to the catheter, the needle is advanced distally through the central lumen defined by the spiral element 406. The needle tip 338 can be completely passed through the valve leaflet and exit from the ventricular side of the valve leaflet as seen in FIG. Anchor deployment actuators, such as pushers that extend through the needle, can be used to deploy the anchor from the needle into the ventricle.

Referring to FIG. 5, the valve leaflet anchor may be a Prejet 340 similar to that described elsewhere herein. The Prejet 340 may be attached or attached to the distal end of the leaflet anchor suture 344. The pledget may include a soft and / or flexible material such as cloth (fabric) . The suture 344 may extend through the needle 336. The Prejet 340 is folded or compressed in a form that includes a reduced radial cross section so that it can be placed within the needle 336 for delivery, as shown in FIGS. 8 and 10 discussed below. be able to. As shown in FIG. 5, the Prejet 340 can be expanded from a reduced cross section in order to assume a larger radial cross section when deployed from the distal end of the needle tip 338. In some embodiments, the Prejet 340 can be pushed through the needle 336 via a push wire or a release wire (not shown). When delivered through the needle tip 338, the proximal retraction of the leaflet suture 344, as shown in FIG. 6, is a form in which the leaflet anchor is axially folded and radially expanded. It can be taken, which prevents the apex anchor from retracting through the apex puncture, thereby fixing the apex suture 344 to the apex, as shown in FIG.

6A-6D schematically show the Prejet 340 connected to the distal end of the leaflet suture 344. The Prejet 340 may include two wings 341, 342, which are rolled / folded and shrunk around the vertical axis of the Prejet 340 (eg, both clockwise or counterclockwise). It is possible to form a cross-sectional shape. In some embodiments, the leaflet suture 344 may be integrally formed with the Prejet 340. To produce a foldable configuration, the suture 344 extends distally through the prejet, loops around the distal end of the prejet, returns proximally, as shown in FIG. 6A. , May be unscrewed through one or more openings formed within the Prejet 340 (eg, two openings, three openings, four openings, etc.). In some embodiments, the openings may be aligned along the center of the Prejet 340.

The opening can extend through the Prejet 340 and through the portion of the embedded portion of the suture 344 that is integrated with the Prejet 340. The embedded portion of the suture 344 may be partially flattened at least within the prejet 340. In some embodiments, the openings may be located substantially near the center of the prejet (eg, in the immediate vicinity of the left or right of the embedded suture 344, or with the left side of the suture 344. It may be arranged alternately between the right side). When unfolded, the suture 344 can be effectively coupled to the distal end of the Prejet 340 (eg, the suture 344 can return the loop to a position where it is inserted between the Prejet sheets). ..

6B-6D schematically show examples of prejets as described elsewhere herein. FIG. 6B schematically shows a Prejet 340 formed by affixing the distal end (indicated by a dashed line) of suture 344 between two flat sheets, resulting in left and right wings 341, 342. A sheet is formed for. FIG. 6C shows a cross section of the Prejet 340 along the axis of BB illustrated in FIG. 6B. In some embodiments, the suture 344 is inserted between the two sheets (eg, substantially downward in the middle of the sheets) to join the three components together (eg, heat). And / or under pressure) and / or can be laminated. At least one layer can be partially sintered. The suture 344 can be flattened and / or densified to improve resistance to suture rupture. The sheet may be a flat polytetrafluoroethylene (PTFE) sheet (eg, a thin uncured extended PTFE (ePTFE) sheet) or other suitable material. In some embodiments, the leaflet suture 344 may be placed between the sheets in a different configuration, such as a zigzag or S-shaped shape. FIG. 6D shows Prejet 340 of FIG. 6B including a plurality of openings 343 for sewing the proximal tail end of suture 344.

In some embodiments, to form a foldable structure configured to secure the suture 344 to the mitral valve leaflet, as described elsewhere herein. One or more openings 343 can be formed through the prejet in various forms. FIG. 6D alternately shows openings 343 around both sides of the suture 344. In some embodiments, the opening 343 may be formed on the same side of the suture 344 (eg, wing 341 or wing 342). In some embodiments, the opening 343 can be formed through the suture 344. The openings 343 may be aligned along the center of the Prejet 340. The openings 343 may be aligned along the length of the suture 344 (eg, may form a straight line). The suture 344 can be at least partially flattened between the two opposing sheets, which facilitates the placement of the opening 343 via the suture 344. Various combinations of openings 343 can be used, including the above arrangements.

The Prejet 340 may be formed so that the wings 341 and 342 are approximately the same size, or may be formed to be different sizes. Upon retreating the valve leaflet suture 344 to the proximal side, the Prejet 340 may be folded into an accordion-like form, as shown in FIG. 6A. The pledge 340 may include a proximal surface of a substantially plane perpendicular to the major axis of the leaflet suture 344. This form may facilitate the fixation of the suture 344 to the valve leaflet. Once the leaflet suture 344 is secured in the leaflet, the leaflet anchor delivery subsystem 340 is withdrawn from the delivery catheter 100. The valvular anchor delivery component, along with the ventricular anchor suture 74, may retract proximally beyond the proximal end of the suture 344 that remains extending through the delivery catheter 100 to the valvular anchor 340.

8-10 show various diagrams of the leaflet anchor delivery subsystem 330 and its components. FIG. 8 shows a perspective view of the distal end of the subsystem 330. FIG. 9 shows a perspective view of the proximal end of the subsystem 330. FIG. 10 shows an exploded view of the distal end of the subsystem 330.

As shown in FIGS. 8 and 10, the leaflet anchor delivery subsystem 330 can include an outer delivery tube 332. The tube 332 may optionally include a deflection zone, such as by retreating one or more pull wires (not shown) proximally along the various sides of the flexible tube 332. It may be configured so that the operator can operate it. As shown in FIG. 9, the operator controls the flexion of the flexible tube via a knob 352 or lever or other actuating mechanism located on the handle 350 at the proximal end of the valve leaflet anchor delivery subsystem 330. can do.

An inner tubular shaft or needle 336 ending at the distal end at the needle tip 338 can extend through the delivery tube 332. The internal needle 336 may include a hypo tube, extruded tube or braided tube or catheter that is flexible enough to fit the shape of any flexible tube 332. The needle tip 338 may be coupled to the distal end of the medial flexibility shaft 336. The flexible jacket 333 may surround the flexible tube 332 and the delivery shaft 334.

As shown in FIG. 9, the proximal end of the inner tubular shaft 336 may be connected to the needle handle 354. The needle handle 354 can include a hemostatic valve 356. The leaflet suture 344 can be inserted through the valve 356. The valve 356 may be a tuohy-borst valve. The needle handle 354 can include an additional port 358 for accessing the lumen of the inner flexible shaft 336. The needle handle 354 may be located proximal to the handle 350 such that the inner flexible shaft 336 extends through the handle 350 into the lumen of the delivery shaft 334. The handle 350 may be provided with a hemostatic valve for receiving the inner flexible shaft 336 and sealing the internal components of the handle, including the opening to the delivery shaft 334, from the ambient environment.

The needle tip 338 may be telescopic by extending the needle handle 354 toward the handle 350 or retracting the needle handle 354 from the handle 350. Distal advancement of the needle 336 can be achieved by manually advancing the handle 354. Alternatively, the distal advance of the needle may be assisted by a mechanical or electromechanical mechanism that produces a relatively fast, short stroke length distal advance.

As shown in FIG. 4, the needle tip 338 extends to the opposite side of the valve tip (for example, the atrial side) due to the generation of pressure on the valve leaflet when the needle tip 338 extends distally beyond the tube 332. As such, the needle tip 338 may be punctured into the valve leaflet. This pressure can be generated by extending the needle tip 338 and / or retracting the entire delivery device 330 proximally with the needle tip 338 in the extended position.

The ventricular anchor suture 74 and the leaflet anchor suture 344 are tensioned together to form a new chordae tendineae implant or to connect two sections of the new chordae tendineae implant together. As a result, the new chordae tendineae extend across the atrial side of the coaptive edge of the valve leaflet between the ventricular anchor 302 and the valve leaflet anchor 340. The total length of the new chordae tendineae is adjusted by pulling to the proximal side of one or both of the sutures 74 and 344 prior to engaging the suture lock 376 so that moderate tension is applied to the valve leaflets. The tension is maintained by the ventricular anchor 302. The sutures 74 and 344 may extend proximally through the delivery catheter 100 to the lateral position of the body. In some embodiments, the proximal end of the suture 74, 344 is the handle or proximal portion of the suture lock delivery system 370 to facilitate the placement of the suture lock and the cutting of the suture 74, 344. May be supplied to. In some embodiments, the proximal end may remain free or may be connected or secured by other means.

FIG. 11 shows the advance of the suture lock 376 over the ventricular anchor suture 74 and the valve leaflet suture 344. The suture lock delivery subsystem 370 can be advanced through the delivery catheter 100 and the tubular pusher catheter 372 can push the suture lock 376 along the distal direction of the suture 74, 344. Once the suture lock 376 reaches the ventricle, proximal traction on the suture 74 allows the suture lock 376 to continue to be pushed along the ventricular suture 74, while the suture lock 376 is distal to the ventricular anchor. If necessary to proceed to, a leaflet suture 344 can be supplied distally through a catheter. As further discussed below, FIG. 12 shows the final configuration in which the leaflet anchor and the ventricular anchor are connected to form an artificial chordae tendineae. The proximal tail of the two sutures was cut and the catheter retracted proximally from the ventricle through the mitral valve.

13-14 show various diagrams of the suture lock delivery subsystem 370 and its components. FIG. 13 shows a perspective view of the distal end of the subsystem 370. FIG. 14 shows a perspective view of the proximal end of the subsystem 370. FIG. 15 shows a partially exploded view of the distal end of the subsystem 370. FIG. 16 shows a perspective view of the distal end of the cutting assembly. 17 and 18 show side views of the cutting assembly portion of the subsystem 370. FIG. 19 shows a side view of the suture lock 376 and the distal end of the torque drive unit 388 configured to engage the suture lock 376. 20 and 21 show the proximal and distal end views of the suture lock 376, respectively.

The suture lock delivery subsystem 370 may be configured to advance (eg, slide) the suture lock 376 across both sutures 74, 344 (or additional three or four or additional sutures). .. The sutures 74 and 344 respectively tension the sutures 74 and 344 and adjust the length of each suture 74 and 344 between the suture lock 376 and the corresponding tissue anchors 302 and 340. It may retract proximal to the suture lock 376. When the tension and length of the new chordae tendineae implant are optimized, the suture lock 376 sets the length of the suture 74,344 so that the suture 74, 344 can no longer move with respect to the suture lock 376. It may be locked to secure. The sutures 74 and 344 can then be cut at a point proximal to the suture lock 376. The sutures 74 and 344 can be cut by the same suture lock delivery subsystem 370 that delivered the suture lock 376. In other embodiments, a separate cutting device may be inserted into the delivery catheter 100 after the suture lock has been locked in place.

The suture lock allows one or more sutures to be advanced and adjusted through it, after which the ePTFE suture is used under normal conditions of use (eg, at least about 60 suture breaking strength without slipping). Lock with sufficient clamping efficiency that can prevent slipping from the suture lock under conditions of use that can withstand% or 80% or more tension. The lock can be re-released to readjust the tension of the mitral valve leaflet and retightened until the desired result is obtained. After that, the tightening tool may be removed while the suture is fixed.

The suture lock 376 can be advanced along the suture by the retention catheter 373. The distal end of the retention catheter 373 may be coupled to the retention element 377 (FIG. 15). The retaining element can include a flange 371 or other mechanical feature configured to engage the suture lock 376. For example, the flange 371 can be inserted into the recess at the proximal end of the suture lock 376. In some embodiments, the retention catheter 373 can be disengaged from the suture lock 376 by rotation of the retention catheter 373 and / or movement approximately perpendicular to the axis of the retention catheter 373.

The sutures 74 and 344 extend from their respective tissue anchors, pass through the suture lock 376, enter through the distal opening 395 of the distal surface of the suture lock 376 shown in FIG. 21, and enter the suture lock 395 shown in FIG. A proximal opening 394 in the proximal plane of the 376 can exit into the suture path. The sutures 74 and 344 can extend through the channel in the cutter head 375 proximal to the suture lock 376, along the outside of the retention catheter 373 and through the delivery catheter 100. The cutter head 375 can be coupled to the distal end of the cutter catheter 372. The retention catheter 373 can extend through the internal lumen of the cutter catheter 372 such that the two catheters 372, 373 can extend or contract with each other.

Once the sutures 74 and 344 are locked (tightly fixed) within the suture lock 376, the proximal end of the sutures 74 and 344 can be cut next to the proximal surface of the suture lock. The sutures 74 and 344 can be cut by advancing the cutter catheter 372 connected to the cutter head 375 toward the proximal surface of the suture lock 376. As schematically shown in FIGS. 17-18, as the cutter head 375 advances along the retention catheter 373 towards the retention element 377, the cutter head cuts sutures 74, 344 placed on the retention element 377. Close to blade 379. The cutter head 375 is configured to advance over the holding element 377 so that the channels in the cutter head 375 holding the sutures 74 and 344 are gradually occupied spatially by the blade 379. When the blade 379 is pushed into the channel of the cutter head 375, the blade 379 shears the sutures 74 and 344. The application of proximal tension to the sutures 74 and 344 can facilitate the cutting of the sutures 74 and 344. In other embodiments, different actions (eg, rotation of the cutting catheter) can be configured to cut the sutures 74, 344.

In some embodiments, two or more sutures can be used, locked within the suture lock 376 and cut in a similar manner by the suture lock delivery subsystem 370. In some embodiments, the advancement of the cutter head 375 on the retention element 377 can facilitate the removal of the retention catheter 373 from the suture lock 376. For example, the cutter head 375 can advance to a distal position configured to stabilize the suture lock 376 and detach the retention catheter 373 axially and / or rotationally from the suture lock 376. can.

FIG. 19 shows a side view of an example of a suture lock 376 (showing its outer casing / shell removed). The suture can pass through the suture lock 376 from the distal end to the proximal end, as described elsewhere herein. The suture lock 376 can include a screw 382 configured to advance or retract the push wedge 384 distally or proximally, depending on the direction of rotation. The screw 382 may be rotated by a torque shaft 388. The torque shaft 388 has a recess 381 (eg, a polygonal recess or the like, as shown in FIG. 20) located at the proximal end of the suture lock 376 so that the rotation of the torque shaft 388 causes the rotation of the screw 382. A drive head configured to fit into a non-circular recess) can be provided. The torque shaft 388 can extend through the internal lumen of the retention catheter 373. The torque shaft 388 can be rotated at the proximal end by a knob 398 or other actuating mechanism located at the proximal end of the subsystem handle 396. The handle 396 can include a hemostatic valve 397. In some embodiments, sutures 311 and 344 can pass through the hemostatic valve 397.

The advance of the push wedge 384 by the torque shaft 388 allows the angled surface 386 to gradually compress one or more springs, such as the spring pin 388. The spring urges the clamp upward to open the suture path until it is forcibly closed by the rotation of the torque shaft 388. The compressive force of one or more springs 388 pushes the clamp 390 downward onto the sutures 311 and 344, compressing the sutures 311 and 344 between the two opposing surfaces. In some embodiments, the clamp 390 and the facing surface 392 may have notched surfaces configured to fit together in individual augmentations. The fitted notch surface can provide enhanced friction, and in some embodiments, the sutures 311 and 344 are pulled out either proximally or distally from the suture lock 376. It can provide mechanical interference to hold the suture between the facing surfaces so that it cannot. In some embodiments, tightening may be reversible by rotating the torque shaft in opposite directions.

Once the suture lock is properly placed on the suture 74, 344 and locked in place, the suture 74, 344 can be cut as described elsewhere herein. FIG. 12 shows the storage of the suture lock delivery subsystem 370 after the sutures 74 and 344 have been cut. When the suture lock delivery subsystem 370 is removed from the delivery catheter 100, the delivery catheter 100 can be withdrawn from the body.

Although the present disclosure describes specific embodiments and examples, many aspects of the above systems and methods are combined differently to form yet another embodiment or acceptable example, and / Or can be modified. All such modifications and variations are intended to be included herein within the scope of this disclosure. In fact, a wide variety of designs and approaches are possible and are within the scope of this disclosure.

Moreover, the particular features described in the present disclosure as the content of a separate embodiment can also be implemented in combination in a single embodiment. Conversely, the various features described as the content of a single embodiment can also be implemented separately in multiple embodiments or in any suitable subcombination. Further, a feature described as acting in a particular combination may also have one or more features of the claimed combination removed from the combination in some cases, such a combination being a sub. A patent may be claimed as a combination or a modification thereof.

Disclosures herein of any particular feature, aspect, method, characteristic, characteristic, quality, attribute, element, etc. associated with various embodiments are used in all other embodiments set forth herein. be able to. Also, any of the methods described herein can be performed using any device suitable for performing the described steps.

Further, parts and actions are depicted in the drawings or described in the specification in a particular arrangement or order, but in order to obtain the desired result, such parts and actions are specified as shown in the drawings. It does not have to be sequenced and practiced in sequence and order, nor is it a continuous sequence, nor does it need to include all parts and operations. Other components and actions not shown or described can be incorporated into embodiments and embodiments. For example, one or more additional actions can be performed before, after, simultaneously with, or in between any of the described actions. Furthermore, the operation may be reorganized or re-implemented in other embodiments. Also, the separation of the various system components in the above embodiments should not be understood as requiring such separation in all embodiments, and the described components and systems are generally a single product. It should be understood that it can be integrated into or packaged into multiple products.

In summary, various exemplary embodiments and examples are described herein. Although the systems and methods are disclosed as their embodiments and examples, this disclosure goes beyond the specifically disclosed embodiments to other embodiments and / or other uses of the embodiments. , As well as their specific modifications and equivalents. The present disclosure expressly intends that the various features and embodiments of the disclosed embodiments may be combined or replaced with each other. Therefore, the scope of the present disclosure should not be limited by the particular disclosed embodiments described above, but should be determined only by the fair reading of the claims and the full range of their equivalents.

Clause 1. It is a method of transplanting transvascular artificial chordae tendineae.
A step of inserting a catheter into the left atrium and entering the left ventricle through the mitral valve.
A step of deploying a ventricular anchor from the catheter into the wall of the left ventricle, leaving a ventricular suture attached to the ventricular anchor and extending proximally through the catheter.
From the atrial side, the step of fixing the valve leaflet anchor to the mitral valve leaflet,
In order to secure the mitral valve leaflet to the valve leaflet suture extending proximally through the catheter, the valve leaflet anchor was provided with the valve leaflet anchor catheter fixed to the valve leaflet. The step of entering from the catheter through the mitral valve leaflet,
A method comprising: fixing the leaflet suture to the ventricular suture to limit the range of movement of the leaflet toward the left atrium.
Clause 2. In the step of advancing the valve leaflet anchor from the catheter through the mitral valve leaflet to fix the mitral valve leaflet to the valve leaflet suture, a needle preloaded with the valve leaflet anchor is placed on the upper surface of the mitral valve leaflet. The method described in Clause 1, including the steps to proceed through.
Clause 3. The method of clause 2, wherein the step of fixing the leaflet anchor catheter to the mitral valve leaflet comprises the step of using a valve leaflet connector.
Clause 4. The method of clause 3, wherein the valve leaflet connector comprises a spiral anchor.
Clause 5. The method of clause 3, wherein the valve leaflet connector comprises a hook.
Clause 6. A method of fixing the valve leaflet anchor to the mitral valve leaflet,
The step of inserting the catheter into the atrium and
From the atrial side, the step of fixing the valve leaflet connector coupled to the catheter from the atrial side of the valve leaflet to the mitral valve leaflet,
A method comprising the step of fixing the mitral valve tip to the mitral valve leaflet and then allowing the valve leaflet anchor to enter through the mitral valve leaflet in order to fix the mitral valve leaflet to the valve leaflet suture.
Clause 7. The step of advancing the valve leaflet anchor through the mitral valve leaflet to fix the mitral valve leaflet to the valve leaflet suture is a step of advancing the needle preloaded with the valve leaflet anchor from the atrial side through the mitral valve leaflet. The method described in Clause 6, including.
Clause 8. The method of clause 7, wherein the needle is advanced through the valve leaflet connector.
Clause 9. The method of clause 8, wherein the valve leaflet connector comprises a spiral anchor.
Clause 10. The method of clause 8, wherein the valve leaflet connector comprises a hook.
Clause 11. Valve tip anchor deployment system,
A catheter with a proximal end and a distal end,
A valvular connector located at the distal end of the catheter,
With a needle that can enter through the valve leaflet connector,
A valve leaflet anchor deployment system in which the needle is contained within a preloaded, radially expandable valve leaflet anchor and has a suture extending proximally through the catheter.
Clause 12. The valve leaflet anchor deployment system according to clause 11, wherein the valve leaflet connector is a spiral anchor.
Clause 13. A new chordae tendineae deployment system
A catheter with a proximal end and a distal end,
A spiral ventricular anchor subassembly that is extendable through the catheter and has a ventricular suture extending proximally through the catheter.
A neoplasia with a valvular anchor deployment subassembly that is extendable through the catheter and is internally radially expandable and has a valvular anchor suture extending proximally through the catheter. Chordae tendineae deployment system.
Clause 14. 13. The neo-chordae tendineae deployment system according to clause 13, wherein the radially expandable valve leaflet anchor comprises a prejet.
Clause 15. 12. The neo-chordae tendineae deployment system according to Clause 14, wherein the prejet can be transformed from an elongated strip structure into an axially shortened structure that expands radially by contraction of the suture to the proximal side.
Clause 16. The neoplastic chordae tendineae deployment system according to Clause 13, wherein the radially expandable leaflet anchor comprises a leaflet suture placed between two sheets of material.
Clause 17. The neo-chordae tendineae deployment system according to clause 13, wherein the radially expandable valve leaflet anchor is carried into a needle having a sharp tip for drilling the leaflet.
Clause 18. 25. The neo-chordae tendineae deployment system according to Clause 17, wherein the flap anchor deployment subassembly comprises an elongated tube with a distal end and a central lumen and a flap connector at the distal end.
Clause 19. The neo-chordae tendineae deployment system according to clause 18, wherein the leaflet connector comprises a spiral leaflet anchor.
Clause 20. 19. The neo-chordae tendineae deployment system according to clause 19, wherein the needle is axially movable with respect to the spiral valve leaflet anchor.
Clause 21. The new chordae tendineae deployment system according to clause 13, further comprising a suture lock subassembly that is advanceable through the catheter and is configured to connect the ventricular suture to the leaflet suture.
Clause 22. Valve tip anchor delivery subsystem
An elongated flexible tubular body with proximal, distal and central lumens,
A deployable needle that can move forward axially through the central lumen,
A foldable prejet valve tip anchor carried into the unfolding needle,
A valvular anchor delivery subsystem comprising a valvular connector carried by the distal end of the tubular body.
Clause 23. The valve leaflet anchor delivery system according to clause 22, wherein the valve leaflet anchor comprises a spiral element.
Clause 24. 23. The valve leaflet anchor delivery system according to clause 23, wherein the unfolding needle is axially extendable through the spiral element.
Clause 25. An organization anchor
With a hub
A suture extending proximally from the hub,
A spiral anchor extending distally from the hub,
A tissue anchor comprising a core wire that extends concentrically beyond the distal end of the helical anchor through the helical anchor.
Clause 26. The tissue anchor according to clause 25, further comprising a suture anchor guide extending proximally from the hub.
Clause 27. The tissue anchor according to clause 25, further comprising a tubular sleeve having a length of about 10 cm or less extending proximally from the hub.
Clause 28. In addition, the tissue anchor according to clause 27, comprising a radiodensity marker carried by the sleeve.
Clause 29. The tissue anchor according to clause 25, further comprising a radiation opaque marker that is axially movably carried by the core wire.
Clause 30. In addition, the tissue anchor according to clause 29, comprising a spring carried by the core wire.
Clause 31. Further comprising a tissue perforation point on the distal end of the spiral anchor and a spine on the spiral anchor configured to resist rotation of the spiral anchor to disengage from tissue. 25. Tissue anchor.
Clause 32. A tissue anchor with a dynamic depth indicator,
With a hub
A tissue anchor extending distally from the hub,
A core wire extending distally from the hub,
A radiation opaque marker that is movably carried by the hub,
A spring, which urges the radiodensity marker distally, is provided.
The radiodensity marker is a tissue anchor that advances proximally to the tissue anchor in response to the tissue anchor advancing into the tissue.
Clause 33. Intravascular suture lock,
A body with a suture path that extends through the interior,
A movable wall in the housing for reducing the cross-sectional dimension of the suture path,
With the rotatable joint in the housing,
An intravascular suture lock comprising a driving mechanism that advances the movable wall in response to rotation of the joint.
Clause 34. The intravascular suture lock according to clause 33, comprising an exposed friction-enhancing surface in the suture path.
Clause 35. The intravascular suture lock according to clause 34, wherein the friction-enhancing surface is on a movable wall.
Clause 36. The intravascular suture lock according to clause 33, which has an angled surface and comprises a push wedge that is axially movable within the housing.
Clause 37. The intravascular suture lock according to clause 36, wherein the rotation of the coupling causes the push wedge, which advances the movable wall laterally, to advance axially to change the cross-sectional dimension of the suture path.
Clause 38. The movable wall includes a suture gripping surface on the first side and an inclined surface on the second side, and the inclined surface is configured to be in sliding contact with an angled surface on the push wedge. 37. Intravascular suture lock.

Claims (15)

Valve tip anchor deployment system,
A catheter with a proximal end and a distal end,
A valvular connector located at the distal end of the catheter,
With a needle that can enter through the valve leaflet connector,
Equipped with
The needle is characterized by having a preloaded, radially expandable valve leaflet anchor internally and a suture extending proximally through the catheter. .. The valve leaflet anchor deployment system according to claim 1, wherein the valve leaflet connector has a sharp tip for drilling the valve leaflet. The valve leaflet anchor deployment system according to claim 1 or 2, wherein the valve leaflet connector has a spiral tissue anchor . The radially expandable valve leaflet anchor is characterized in that it can be expanded from an axially extending structure in the needle to an axially shortened and radially expanding structure with respect to the valve leaflet. The valve leaflet anchor deployment system according to claim 1 . 4. The radially expandable valve leaflet anchor comprises a fabric prejet having a plurality of transverse folds forming a plurality of stacked panels in the axially shortened structure. Described valve leaflet anchor deployment system . The valve tip anchor deployment system according to any one of claims 1 to 5, further comprising a push wire for pushing out the radially expandable valve tip anchor from the needle . The valve leaflet anchor deployment system according to claim 4 , wherein the conversion to the structure shortened in the axial direction and expanded in the radial direction is performed by retracting the valve leaflet anchor suture in the proximal direction. .. 5. The fifth aspect of claim 5 , wherein the fabric prejet has two wings configured to fold around a longitudinal axis of the fabric prejet to form a reduced cross-sectional morphology. Valve tip anchor deployment system . The valve leaflet anchor deployment system according to claim 5 , wherein the fabric prejet comprises two sheets and a distal portion of the leaflet anchor suture is attached between the two sheets . The valve leaflet anchor deployment system according to claim 9 , wherein the distal portion of the valve leaflet anchor suture is flattened between the two sheets . The valve leaflet anchor deployment system according to any one of claims 5 or 8 to 10, wherein the fabric prejet comprises ePTFE . The valve leaflet anchor deployment according to claim 9 , wherein the two sheets have a plurality of openings, and the valve leaflet anchor suture extends slidably through the plurality of openings. system. The valve leaflet anchor deployment system according to claim 3, wherein the needle is axially movable with respect to the spiral valve leaflet anchor . Further equipped with a valvular anchor deployment subassembly extending through the catheter,
The valve leaflet anchor deployment system according to any one of claims 1 to 13, wherein the valve leaflet anchor deployment subassembly has an elongated tube having a distal end and a central lumen . The valve leaflet anchor deployment system according to claim 14, wherein the needle is axially movable through the central lumen of the elongated tube .