Transcatheter treatment of atrioventricular valves to treat leaflet prolapse

Abstract

Methods and apparatus for treating atrioventricular valve prolapse. An implant (30) configured to connect to the native chordae tendineae (20) and to shorten the functional length of the native chordae tendineae is delivered into the heart through a catheter (32).

Description

Technical Field

[0001] The present invention relates to the field of transcatheter treatment of atrioventricular heart valves. Some non-limiting aspects relate to treating prolapse of native valve leaflets. Background Art

[0002] The mammalian heart has two atrioventricular (AV) valves, which internally regulate blood flow between the atria and ventricles. Proper AV valve function is essential to maintaining the heart's efficient pumping of blood. In a healthy heart, each AV valve opens during diastole to allow blood to enter the ventricles from the atria, and closes during systole to prevent backflow. However, many patients suffer from AV valve insufficiency, when the valve leaflets do not close properly, a life-degrading and potentially life-threatening condition. Backflow of blood through the valves reduces the efficiency of the heart, requiring the heart muscle to work harder to compensate. Backflow not only reduces blood flow from the heart to circulate to the organs, but also exposes the atria to abnormal increases in blood pressure. Excessive atrial pressure can negatively affect the atria and the veins that flow into the heart, and can also hinder the free flow of blood into the heart.

[0003] There are many possible causes of atrioventricular valve insufficiency. A common cause is prolapse of one or both native valve leaflets. If the patient is a candidate for open-heart surgery, prolapse can be treated with a variety of surgical techniques, such as mitral annuloplasty, chordal shortening by surgically embedding the chordae in the papillary muscle trench, and more recently, surgical implantation of artificial chordae. However, a large number of patients are not suitable for open-heart surgery, for example, due to age or frailty or other risk factors and comorbidities.

[0004] Minimally invasive treatment of atrioventricular valve prolapse has long been pursued, but current technology has great limitations. Minimally invasive options include transcatheter implantation of prosthetic replacement valves, and transcatheter implantation of devices that modify native valve devices (native valve apparatus), such as leaflet clips, leaflet coaptation surfaces, artificial chords, and annuloplasty devices. However, current replacement of atrioventricular valves is expensive, relatively large in size and has special anchoring, and requires large diameter catheters, which limits the accessibility of apical approaches. Leaflet clips and coaptation modification devices limit the ability of the valve to open completely, and therefore the treatment may have undesirable side effects. Artificial chords are problematic because they must be anchored to native tissue at either end, which is difficult to achieve reliably using only catheter tools. In addition, unlike native chords (natural chords), it is impossible to connect artificial chords to the movable area of ​​the leaflets. Therefore, artificial chords cannot play the full function of native chords. Transcatheter annuloplasty devices can improve valve function to some extent but are best used in combination with another treatment.

[0005] Some examples of current technology are described in US2005 / 021057, US2018 / 206992 and US2007 / 255396. Summary of the invention

[0006] It would be desirable to address and / or mitigate one or more of the above-identified problems.

[0007] In summary, a first aspect of the invention provides a device for treating atrioventricular valve (AV valve) prolapse, the device comprising an implant deliverable by a catheter, the implant being configured to connect (attach) to native chordae tendineae (natural chordae tendineae) and shorten the functional length of the chordae tendineae.

[0008] As used herein, the term "chordae tendineae" or hereinafter "chordae" refers to any bundle of tissue cords that connect the native atrioventricular valve leaflets to the papillary muscles. Optionally, an implant can be connected to a single native chord and shorten the functional length of the corresponding single chord. Thus, the term "chord" can refer to a single cord (cord-like tissue) or a plurality of cords, where appropriate.

[0009] By shortening the functional length, existing native chordae can better limit the range of motion of the native leaflets and correct leaflet prolapse without the many limitations and inconveniences of the prior art discussed above. The shortening of the functional length can also maintain or reestablish the correct anatomical function of the native chordae, a consideration that many prior art techniques overlook. For example, the native chordae can maintain or reestablish tension between the native leaflets and the ventricular papillary muscles, which may be beneficial to cardiac function and ventricle modeling behavior.

[0010] Shortening the functional length of a chord (e.g., a single chord) may in particular include shortening the functional length independently of at least one other chord. Additionally or alternatively, shortening the functional length of a chord (e.g., a single chord) associated with a first leaflet may in particular include shortening the functional length independently of a chord associated with a second leaflet that is coapted with the first leaflet (e.g., an opposing leaflet of a bileaflet).

[0011] In some embodiments, the implant is configured to shorten the functional length by diverting a portion of the native chordae tendineae along a circuitous path. The circuitous path can optionally be a path into the implant, for example, into the implant lumen and / or into a space at least partially defined by the implant. Optionally, the implant at least partially defines a circuitous path along which the diverted portion of the native chordae tendineae extends, optionally at least most of the circuitous path, optionally substantially all of the circuitous path. By using the implant to define the circuitous path, at least most of the diverted portion of the native chordae tendineae is controlled and supported by the implant without freely swinging or trembling in an uncontrolled manner, which otherwise may be unnatural and / or undesirable from a surgical point of view. The circuitous path defined by the implant can produce or be equivalent to producing folds or wrinkles in the native chordae tendineae.

[0012] In some embodiments, the device includes a hook element for hooking native chordae. The hook can form a portion of an implant or a portion of a delivery catheter for delivering the implant to a target site in the heart. The hook can be configured to pull the native chordae in a proximal direction, the proximal direction being defined relative to the catheter. In addition or as an alternative, the hook can be configured to pull a portion of the native chordae into and / or through a portion of the implant, for example, into and / or through (i) the cavity of the implant, and / or (ii) the space defined by the implant, in response to relative motion between the implant portion and the hook.

[0013] In some embodiments, the hook element has a permanent hook configuration. In other embodiments, the hook element can be configured to change configuration. The hook element can change configuration between at least any two of the following: a hooked configuration for selectively hooking native chordae tendineae; a non-hooked and / or released configuration for releasing (or allowing release) native chordae tendineae from hooked engagement; and a closed configuration in which the cavity of the hook element is closed. Hook elements with variable configurations are subsequently described below.

[0014] In addition or as an alternative to any of the above, in some embodiments, the device includes a puller element for pulling a portion of the native chordae tendineae from a first end of the space defined by the implant into / and through the space from a second end of the space.

[0015] The retractor may form part of the implant or part of a delivery catheter for delivering the implant to a target site in the heart.The retractor may optionally be configured to pull the native chordae in a proximal direction, the proximal direction being defined relative to the catheter.

[0016] In some embodiments, the retractor element has a hook configuration, for example, as described above. In addition or alternatively, the retractor element can be configured to change configurations. The retractor element can change configurations between at least any two of the following: an engagement configuration for selectively hooking or accepting (admit) native chordae tendineae; a release configuration for releasing (or allowing release) native chordae tendineae from engagement; and a closed configuration in which the lumen of the retractor element is closed.

[0017] In some embodiments, the implant is configured to keep at least a portion of the chordae tendineae pulled into (or pulled through) the segment. For example, at least a portion of the implant can be configured to contract around the pulled-in (or pulled-through) portion. In addition or as an alternative, a retainer (e.g., at least one retainer element, optionally at least two retainer elements, optionally at least three retainer elements) can be configured to prevent the pull-out of the pulled-in (or pulled-through) portion.

[0018] The retainer (e.g., retainer element) may include a projection that projects into the interior space and / or inwardly projects from the wall of the implant. The wall may be formed as one or more of a ring, a collar, a sleeve, a tube (whether or not the wall has an opening therein). In addition or as an alternative, the projection may be integrally formed with the wall. For example, the projection may be a tab or a finger that (i) may be folded into a gap and / or plane of the wall from which the projection extends, and / or (ii) extends from the periphery of the wall.

[0019] In some embodiments, the implant can be configured to change configuration between a non-deployed configuration for delivery to a target site in the heart and a deployed configuration for attachment to native chordae tendineae.

[0020] For example, the implant can include a first portion and a second portion, one portion being configured to expand around or relative to and / or fold around the other portion when the implant is changed from a non-expanded configuration to a deployed configuration.

[0021] Additionally or alternatively, the implant can be configured to compress and / or squeeze around native chordae tendineae when the implant is changed from a non-deployed configuration to a deployed configuration.

[0022] In some embodiments, the implant includes a curved surface configured to define a circuitous path that is at least partially curved by the native chord. Optionally, the curved surface defines a major part of the circuitous path as a curved path. Providing a curved path can provide atraumatic contact with native chord tissue and increase path length.

[0023] In addition or as another option, the implant includes an extended (elongated, elongated, slender, elongate) clamping surface, which is configured to provide a spread clamping contact (spread) along a portion of the length of the native chordae tendineae. The extended clamping surface can optionally be any one or more of the following: curved; straight; curvilinear; defined by interlocking toothed profiles (interlocking toothed profiles, interlaced toothed profiles).

[0024] Additionally or alternatively to any of the above, the implant may have a streamlined shape, and in some instances, a bead shape (optionally a spherical shape). The streamlined shape may reduce any tendency of the implant to be affected by blood flow around the implant.

[0025] In addition or as an alternative, the implant can have less than 6mm, optionally less than 5mm, optionally less than (for example, maximum) transverse dimension (transverse dimension) (for example, diameter) of 4mm. For example, size can be in the scope of 2 to 5mm, optionally in the scope of 2 to 4mm, optionally in the scope of 2 to 3mm.

[0026] In addition or as an alternative to any of the above, the above implant may include and / or be made of one or more lightweight materials, such as one or more of the following: titanium; titanium-containing alloys; polyetheretherketone (PEEK); pyrolytic carbon (pyloric carbon). Lightweight materials can reduce the load on the native chordae tendineae and can also reduce the risk of the native chordae tendineae being completely disconnected at both ends, even if the diseased or damaged native chordae tendineae are broken at a certain point.

[0027] In addition or as an alternative to any of the above, the implant may include a mesh and / or braided structure. Such a structure may combine flexibility with a sufficiently strong predetermined shape, for example, in an expanded configuration, to maintain a secure and atraumatic connection with native tendon chordae.

[0028] In addition or as an alternative to any of the above, the implant may include one or more surfaces that are at least partially limited to accommodate and press the passages of native tendon chords extending therethrough. At least one surface may include and / or be coated with and / or carry (e.g., as a liner) a compressible and / or flowable material that can conform at least partially around the native tendon chord contour while frictionally engaging the native tendon chords. Example materials include silicone, polyurethane foam, and biocompatible rubber. This arrangement can provide a firm but non-traumatic engagement with native tendon chords.

[0029] A closely related second aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a hook for hooking onto the native chordae tendineae, the hook being positioned internally relative to a portion of the implant.

[0030] A closely related third aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a hook for hooking onto the native chordae tendineae, the hook being movable within a portion of the implant.

[0031] A closely related fourth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a structure configured to divert a portion of the native chordae tendineae along a circuitous path, at least a majority of which is defined by the implant.

[0032] A closely related fifth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a first portion and a second portion, the second portion being configured to expand around and / or relative to the first portion when the implant is changed from a non-expanded configuration to an expanded configuration.

[0033] A closely related sixth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a first portion and a second portion, the second portion being configured to fold around and / or relative to the first portion when the implant is changed from a non-expanded configuration to an expanded configuration.

[0034] A closely related seventh aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a structure defining a path for accommodating native chordae tendineae, the structure being configured to compress and / or squeeze around the path when the implant is changed from a non-deployed configuration to a deployed configuration.

[0035] A closely related eighth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a structure defining a path for accommodating native chordae tendineae, the structure being configured to squeeze the native chordae tendineae and / or squeeze around the native chordae tendineae when the implant is changed from a non-deployed configuration to a deployed configuration.

[0036] A closely related ninth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of the native chordae tendineae), the implant comprising an elongated clamping surface configured to provide distributed clamping contact along the native chordae tendineae, the elongated clamping surface being curved, straight or curvilinear.

[0037] A closely related tenth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a curved surface defining an at least partially curved circuitous path for receiving native chordae tendineae. The curved surface may optionally define a majority of the circuitous path as a curved path.

[0038] A closely related eleventh aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a first part pivotally coupled to a second part, the first and second parts together defining a tortuous path of the native chordae tendineae. The portions of the first and second parts defining the tortuous path may optionally define a curved, straight, or curvilinear surface.

[0039] A closely related twelfth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising structure defining a circuitous path of native chordae tendineae that alternates between opposing portions and / or sides of the implant. For example, the structure may define a button-like structure for guiding native chordae tendineae in a meandering and / or undulating path.

[0040] A closely related thirteenth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a first and a second portion having confronting surfaces for capturing (trapping) the native chordae tendineae between them, at least one of the confronting surfaces of the first and second portions comprising at least one projecting tooth, and at least another confronting surface comprising a recess for accommodating the tooth. Optionally, the confronting surfaces of both the first and second portions comprise interfitting toothed profiles, optionally interlocking toothed profiles. In some embodiments, the confronting surfaces are curved. The first and second portions may define a curved, circuitous path that winds around the toothed profile along the length of the curve.

[0041] A closely related fourteenth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a ring structure. The ring structure may optionally include a removable door for allowing native chordae tendineae to enter the interior space of the ring structure. In addition or as an alternative, the ring structure may optionally be configured to fold around a portion of the implant.

[0042] A closely related fifteenth aspect of the invention provides a device for treating atrioventricular valve prolapse (e.g., by shortening the functional length of at least one native chord), the device comprising a plurality of implants (each of which is connectable to the native chord or native chords, respectively), and a delivery catheter having a housing area at or near the distal end for housing the plurality of implants together. In some embodiments, at least two of the plurality of implants can typically be deployed simultaneously via the delivery catheter, e.g., for connection to the same native chord. In addition or alternatively, in other embodiments, the implants can be deployed separately, e.g., for connection to different individual chords and / or different individual chord portions.

[0043] A closely related sixteenth aspect of the invention provides a device for treating atrioventricular valve prolapse (e.g., by shortening the functional length of at least one native chord), the device comprising a delivery catheter packaged in a sterile package, the delivery catheter preloaded with at least one implant deployable by the catheter, e.g., for connection to a native chord. Optionally, the catheter is preloaded with a plurality of implants.

[0044] A closely related seventeenth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of the native chordae tendineae), the implant comprising a mesh and / or woven structure configured to change shape so as to at least partially define the tortuous path of the native chordae tendineae.

[0045] A closely related eighteenth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising at least one part having a shape that is concave in a first direction and convex in a second direction substantially perpendicular to the first direction.

[0046] A closely related nineteenth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising first and second components that, in the deployed state of the implant, are optionally curved around each other in first and second different directions (e.g., perpendicular directions). The implant may have a generally bead or bulb shape. The shape may optionally be generally spherical.

[0047] A closely related twentieth aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant having a generally bead shape at least in the expanded configuration of the implant. The bead shape may optionally be generally spherical.

[0048] A closely related twenty-first aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising, at least in an expanded configuration, one or more surfaces that at least partially define a channel for accommodating and compressing native chordae tendineae extending therethrough. At least one surface may include and / or be coated with and / or carry (e.g., as a cushion) a compressible and / or flowable material that is capable of conforming at least partially around the contours of the native chordae tendineae while frictionally engaging the native chordae tendineae. Example materials include silicone, polyurethane foam, and biocompatible rubber. This arrangement can provide a secure yet non-traumatic engagement with the native chordae tendineae.

[0049] A closely related twenty-second aspect of the invention provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of native chordae tendineae), the implant comprising a spool element for at least partially wrapping a portion of the native chordae tendineae around it.

[0050] The spool element may be configured to rotate about the axis of the spool.

[0051] In some embodiments, the bobbin includes an engagement profile for applying a winding torque to the native chordae tendineae, for at least partially winding the chordae tendineae around the bobbin. In addition or alternatively, the bobbin may include a (e.g., a second) engagement profile for maintaining the bobbin in a set rotational orientation relative to the native chordae tendineae and / or relative to a non-rotating portion of the implant. At least one such engagement profile may include a resiliently biased lug.

[0052] A closely related twenty-fourth embodiment provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of the native chordae tendineae), the implant being configured to draw a portion of the native chordae tendineae into and / or through a portion of the implant and / or at least partially around a portion of the implant, the degree of shortening of the functional length being dependent upon, and optionally being the same as, the length of the portion drawn into and / or through and / or around it.

[0053] A closely related twenty-fifth embodiment provides a catheter-deliverable implant for treating atrioventricular valve prolapse (e.g., by shortening the functional length of the native chordae tendineae), wherein the implant is configured to provide different (variable) degrees of shortening of the functional length of the native chordae tendineae, the degree of shortening corresponding to the length of the native chordae tendineae that are pulled into and / or through the implant and / or around the implant.

[0054] In some embodiments, the implant has a plurality of configurable configurations, each configuration providing a corresponding degree of shortening of the functional length of the native chordae tendineae.

[0055] A closely related twenty-sixth aspect of the invention provides a method of treating an atrioventricular heart valve, the method comprising introducing an implant into the heart on a target side using a delivery catheter, and connecting the implant to native chordae tendineae to functionally shorten the native chordae tendineae.

[0056] The catheter can be introduced into the heart using a transvascular route. In some embodiments, the transvascular route can be a transvenous transseptal route. In other embodiments, the transvascular route can be an arterial route.

[0057] A closely related twenty-seventh aspect of the invention provides a method of treating an atrioventricular heart valve, the method comprising:

[0058] Use medical imaging to observe a patient's beating heart,

[0059] determining, based on the observations, at least one target treatment feature associated with shortening of at least one native chordae tendineae for treating prolapse of one or more leaflets of an atrioventricular valve of a beating heart,

[0060] introducing the catheter into the target site in the patient's beating heart, and

[0061] The catheter is manipulated to connect the implant to the native chordae tendineae, thereby functionally shortening the native chordae tendineae.

[0062] For example, the observing step may include using imaging, such as transesophageal (transesophageal) ultrasound imaging.

[0063] The treatment characteristics may be any one or more of the following: the location of the target chord to be shortened; the degree of shortening of the target chord; the location on the target chord where the implant is to be placed; the number of chords on which one or more implants are to be placed; the number of implants to be implanted.

[0064] The implant may be deployed from and / or through a catheter to connect the implant to the native chordae tendineae.

[0065] The method may be effective to improve the function of a dysfunctional atrioventricular heart valve.The method may act to at least partially correct valve leaflet prolapse.

[0066] The above first to twenty-second aspects may be used independently of each other, or any two or more of the above aspects may be combined together. All possible permutations and / or combinations of the various aspects are expressly contemplated.

[0067] Based on the foregoing it will be appreciated that the techniques of the present invention enable leaflet prolapse to be corrected while preserving the native functionality of the sub-valvular apparatus. Shortening the functional length of native chordae is also distinct from implanting artificial chordae and adjusting the length of the artificial chordae during or after implantation. Artificial chordae are artificial strands or filaments that are less susceptible to damage than native chordae, particularly native chordae that have been extended beyond their normal length and caused leaflet prolapse. In contrast to native chordae, artificial chordae are typically not connected to the movable leaflet region. Special considerations are applied in the design of implants for native chordae to avoid the implant from damaging or wearing out the native tendon tissue of the chordae during repeated opening and closing movements of the movable leaflet portion from which the native chordae extend.

[0068] Although certain features, concepts and advantages have been emphasized above, this is only to help understand certain principles of the present invention, rather than to limit the entire scope. Any novel features or concepts described herein and / or shown in the accompanying drawings, whether or not emphasized, are required to be protected. BRIEF DESCRIPTION OF THE DRAWINGS

[0069] Figure 1 is a schematic cross-sectional view of a ventricle showing a dysfunctional atrioventricular valve with leaflet prolapse.

[0070] Figure 2 is similar to Figure 1 Schematic cross-sectional view showing the correction of prolapse by shortening the functional length of the native chordae tendineae.

[0071] Figure 3a and 3b is a schematic cross-sectional view showing a first example of an apparatus for treating prolapse.

[0072] Figure 4 is a schematic cross-sectional view showing in greater detail the tip of the device shown in FIG. 3 carrying an implant in its non-deployed configuration with the hooks of the device retracted in preparation for deployment of the implant.

[0073] Figure 5 is a schematic side view showing the implant of the first example in its deployed configuration connected to native chordae tendineae.

[0074] Figure 6 is a schematic cross-sectional view of a second example of an implant in its expanded configuration.

[0075] Figure 7 is a schematic cross-sectional view of a third example of an implant.

[0076] Figure 8 is a schematic plan view of a fourth example of an implant.

[0077] Fig. 9 is a schematic side view of a fourth example of an implant.

[0078] Fig.10 is a schematic side view of a fifth example of an implant in an expanded configuration.

[0079] Fig.11 is a schematic side view of a fifth example of an implant in a non-deployed configuration.

[0080] Fig.12 is a schematic side view of a fifth example of an implant connected to native chordae tendineae.

[0081] Fig.13 is a schematic side view of a sixth example of an implant in an expanded configuration.

[0082] Fig.14 is a schematic side view of a seventh example of an implant in a non-deployed configuration.

[0083] Fig.15 is a schematic side view of a seventh example of an implant in a deployed configuration connected to native chordae tendineae.

[0084] Fig.16 is a schematic cross-sectional view of an eighth example of an implant carried by a catheter in a non-expanded configuration.

[0085] Fig.17 is a schematic side view showing the implant being eversioned between its different configurations.

[0086] Fig.18 is a schematic cross-sectional view of an eighth example of an implant in its deployed configuration connected to native chordae tendineae.

[0087] Fig.19 is a schematic side view of a ninth example of an implant in a non-deployed configuration.

[0088] Fig. 20 is a schematic side view of a ninth example of an implant in a deployed configuration connected to native chordae tendineae.

[0089] Fig.21 is a schematic lateral view of a ninth example of an implant.

[0090] Fig. 22 is a schematic side elevational view of a tenth example of an implant in a non-deployed, open configuration carried by a catheter.

[0091] Fig.23 is a schematic side elevational view of a tenth example of an implant in an expanded, closed configuration carried by a catheter.

[0092] Fig.24 is similar to Fig.23 Schematic cross-sectional view of the chordae tendineae, but showing the connection to the native chordae tendineae.

[0093] Fig.25 is a schematic side view of a tenth example of an implant released from a catheter.

[0094] Fig.26 is a schematic perspective view of an eleventh example of an implant in a partially deployed (folded) configuration.

[0095] Fig. 27 is a schematic perspective view of the eleventh example in a non-deployed (opened) configuration.

[0096] Fig.28 is a schematic cross-sectional view of an eleventh example in an expanded (fully folded) configuration connected to native chordae tendineae.

[0097] Fig.29 is a schematic cross-sectional view of a twelfth example of an implant in a delivery catheter in a non-expanded configuration.

[0098] Fig.30 is a schematic cross-sectional view of a twelfth example connected to a native chord.

[0099] Fig.31 is a schematic cross-sectional view of a thirteenth example of an implant in a non-expanded configuration within a delivery catheter.

[0100] Fig.32 is a schematic side elevational view of a fourteenth example of an implant comprising first and second components nested together.

[0101] Fig.33 is a schematic cross-sectional view of a fourteenth example of an implant in an expanded configuration.

[0102] Fig.34 is a schematic cross-sectional view of a fourteenth example of an implant in a non-expanded configuration connected to a delivery catheter.

[0103] Fig.35 is a schematic cross-sectional view of the fourteenth example when connected to native chordae tendineae and released from a delivery catheter.

[0104] Fig.36 is a schematic cross-sectional view showing a delivery catheter of a fourteenth example.

[0105] Fig.37is a schematic cross-sectional view of a fifteenth example of an implant in a deployed configuration connected to native chordae tendineae.

[0106] Fig.38 is a schematic perspective view of a sixteenth example of an implant having a retainer protrusion.

[0107] Fig.39 yes Fig.38 Schematic side view of an implant.

[0108] Fig.40 Yes Display Fig.38 and 39 Schematic side view of a first deployment stage of an implant.

[0109] Fig.41 Yes Display Fig.38 and 39 Schematic side view of the second deployment stage of the implant.

[0110] Fig.42 is a schematic side view of an implant connected to native chordae tendineae.

[0111] Fig.43 is a front perspective view of a seventeenth example of an implant similar to the sixteenth example.

[0112] Fig.44 Is displayed using Fig.43 A schematic perspective side view of a first deployment stage of an implant is shown.

[0113] Fig.45 is a schematic perspective side view showing the implant connected to the native chordae tendineae.

[0114] Fig.46 is a perspective view of other configurations of the hook element in the eighteenth example.

[0115] Fig.47 Yes Display Fig.46 A schematic side view of how a hook element may cooperate with an implant is shown.

[0116] Fig.48 is a schematic side view of a nineteenth example of an implant having a single retainer projection extending from opposite sides of the mouth.

[0117] Fig.49 is a schematic side elevational view of a twentieth example of an implant having a single retainer projection extending from adjacent the mouth.

[0118] Fig.50 is a schematic side elevational view of a twenty-first example hook element, wherein the hook element forms a portion of an implant.

[0119] Fig.51 is similar to Fig.50 , but showing the hook element coupled to the catheter shaft.

[0120] Fig.52 is a schematic cross-sectional view of the assembled implant in the implanted state.

[0121] Fig.53 is similar to Fig.50 , but showing the modifications in the twenty-second example.

[0122] Fig.54 is similar to Fig.53 Schematic side view of a catheter, but showing the hook element connected to the catheter shaft.

[0123] Fig.55 is a schematic cross-sectional view of the assembled implant in the implanted state.

[0124] Fig.56 is a schematic cross-sectional illustration of a twenty-third example of an implant carried by a delivery catheter.

[0125] Fig.57 is a schematic cross-sectional view of the twenty-third example at the first stage during implantation to hook the native chordae tendineae.

[0126] Fig.58 is a schematic cross-sectional view of the twenty-third example showing the implant body being advanced toward a retractor.

[0127] Fig.59 is similar to Fig.58 , but showing a retractor passing through the implant body.

[0128] Fig.60 is a schematic diagram of the implant in its implanted state.

[0129] Fig.61 is similar to Fig.56 , but showing a modification of the twenty-fourth example.

[0130] Fig.62 is a schematic cross-sectional view during an implantation procedure, with the retractor components being pulled together.

[0131] Fig.63 is a schematic diagram showing the implant in its implanted state and separated from the delivery catheter.

[0132] Fig.64is a schematic cross-sectional view showing a variable configuration hook element in the twenty-fifth example described herein.

[0133] Fig.65 is a schematic sectional view showing a modified configuration of the hook element in the twenty-sixth example.

[0134] Fig.66 is a schematic cross-sectional view of a modified configuration of the hook element in the twenty-seventh example shown in a relaxed state.

[0135] Fig.67 is a schematic cross-sectional view of the twenty-seventh embodiment in a tensioned state.

[0136] Fig.68 is a schematic perspective view showing a hook element and a concave member of a twenty-eighth example of an implant.

[0137] Fig.69 is a schematic perspective view of an implant in its implanted state.

[0138] Fig.70 is a schematic perspective view from the side of a twenty-ninth example implant having a collapsible hub.

[0139] Fig.71 is similar to Fig.70 Schematic side view of , but with an expanded hub.

[0140] Fig.72 yes Fig.71 Top view of the .

[0141] Fig.73 is a schematic perspective view of a thirtieth example in a staple form.

[0142] Fig.74 yes Fig.73 Schematic diagram of the staples after "stapling".

[0143] Fig.75 is a schematic side view of a stapler unit integrated into a delivery catheter.

[0144] Fig.76 is a schematic side elevational view of a thirty-first example of an implant in the form of a bobbin element.

[0145] Fig.77 yes Fig.76 A schematic perspective view of a spool element is shown.

[0146] Fig.78 is a schematic side view of a spool element mounted on a delivery catheter illustrating a deployment technique for connection to native chordae tendineae.

[0147] Fig.79 is a schematic side elevational view of a thirty-second example of an implant in the form of a bobbin element.

[0148] Fig.80 is a schematic exploded view of the components of the delivery catheter of the thirty-second example.

[0149] Fig.81 is a schematic cross-sectional view showing the deployment of an implant from a delivery catheter.

[0150] Fig.82 is a schematic exploded view of certain components of a thirty-third embodiment of a spool element-based implant and delivery system.

[0151] Fig.83 is with Fig.82 The components shown (including the bobbin element) are schematic side views of other components that work together.

[0152] Fig.84 is a schematic cross-sectional view showing the deployment phase during deployment of the implant.

[0153] Fig.85 is a schematic cross-sectional view showing an implant connected to native chordae tendineae.

[0154] Fig.86 is a schematic flow chart showing the processing (treatment) steps using the implant in the thirty-fourth example. DETAILED DESCRIPTION

[0155] With reference now to the accompanying drawings, non-limiting embodiments of the present invention will be described by way of example. In the accompanying drawings, the same reference numerals designate the same or equivalent features, whether or not explicitly described.

[0156] refer to Figure 1 , shows a portion of a heart 10 having a ventricle 12, an atrium 14, an outflow tract valve (outflow tract valve) 16 leading from the heart to the arteries, and an atrioventricular valve 18 between the ventricle 12 and the atrium 14. The ventricle 12 may be the left ventricle, the outflow valve 16 may be the aortic valve, and the atrioventricular valve 18 may be the mitral valve. Alternatively, the ventricle 12 may be the right ventricle, the outflow valve 16 may be the pulmonary valve, and the atrioventricular valve 18 may be the tricuspid valve.

[0157] The chordae tendineae 20 (hereinafter referred to as chordae) connect the leaflets 22 of the atrioventricular valve 18 to the papillary muscles 24 in the ventricle 12 to control the range of motion of the leaflets 22. Figure 1 In the example of FIG. 1 , at least one leaflet 22' of the atrioventricular valve 18 is shown to be prolapsed, wherein the chordae tendineae 20 do not properly restrain the leaflet 22' within the ventricle during contraction, thereby causing the leaflet 22' to be pushed out of its proper position and at least partially into the atrium. Leaflet prolapse is a major cause of valve insufficiency and atrioventricular regurgitation, as indicated by the white blood flow arrows.

[0158] Figures 2 to 4 A technique of the present invention for treating prolapse via a transcatheter procedure is shown. An implant 30 (optionally, a plurality of implants 30) is delivered into the ventricle 12 via a delivery catheter (32 in FIG. 3). The implant 30 is configured to connect to a native chord 20, optionally a single native chord 20, to shorten the functional length of the native chord 20. By shortening the functional length, the chord 20 can better constrain the leaflets 22', correct prolapse, and restore or improve valve function (e.g., Figure 2 The implant 30 and the delivery catheter 32 may be referred to as a therapeutic device.

[0159] The catheter may be introduced into the ventricle 12 and / or the target site in the atrioventricular valve 18 via a variety of access routes, including transvascular routes. For example, the catheter may be introduced via an arterial route through the outflow valve 16, e.g., a transfemoral or transbrachial / transsubclavian route. Additionally or alternatively, the catheter may be passed through the femoral vein and / or through the septum between the left and right atria 14, i.e., a transseptal route.

[0160] Multiple examples of implants are described below. In some embodiments, implant 30 is configured to be changed from a non-expanded structure for delivery to an expanded structure for connection to native chordae tendineae. When released from a delivery catheter, implant 30 can be self-expanded, and / or the catheter can apply an expansion force to the implant to change the structure. Implant 30 can optionally be made of shape memory material and / or superelastic material, for example, shape memory alloy. A type of such alloy can include at least nickel and titanium, for example, Nitinol alloy. Other suitable materials include one or more of titanium, PEEK and / or pyrolytic carbon (pyloric carbon).

[0161] In some cases, implant 30 can limit a circuitous path, and this path shortens the functional length of native tendon chord by at least 1mm, optionally shortens at least 2mm, optionally shortens at least 3mm, optionally shortens at least 4mm, optionally shortens at least 5mm or about 5mm, optionally shortens at least 10mm, optionally shortens 15-20mm. Optionally, multiple implants 30 can be connected to the same tendon chord to accumulate shortening effect and achieve greater shortening than a single implant. In some embodiments, implant is lightweight, to avoid adding significant load to native tendon chord, especially if the diseased tendon chord breaks at a certain point. In addition, in some embodiments, implant has a streamlined profile in implantation or deployment configuration.

[0162] Implant 30 can be optionally pre-connected to or pre-loaded into a delivery catheter as a sterile assembly. The assembly can be optionally packaged and supplied in a sterile package. Alternatively, the implant can be supplied separately from the catheter and connected to and / or loaded into the catheter shortly before the patient's procedure.

[0163] In some embodiments, the device includes a retractor element, for example, in the form of a hook (e.g., 34). The retractor element can form a portion of the catheter and / or a portion of the implant. The retractor element can be configured to: (i) pull a portion of the native chord in a proximal direction relative to the catheter; and / or (ii) pull a portion of the native chord into and / or through a lumen or space defined by the implant; and / or (iii) pull a portion of the native chord from a first end of the implant through a mouth of the implant at a second (e.g., opposite) end of the implant.

[0164] The hook configuration of the retractor element can provide the advantage of being able to engage around a portion of the native chord to pull the native chord with confidence that the chord will not accidentally slip out of the state of engagement with the hook. In the following embodiments, a hook is shown, but it should be understood that the hook can be replaced by other forms of retractor elements depending on the desired implementation.

[0165] Refer to Figure 3 to Figure 5In a first example, the catheter 32 may include a hook 34 configured to hook the native chord 20 to pull the native chord 20 proximally, i.e., in the proximal direction of the catheter 32 or proximally relative to the catheter 32. In the illustrated example, the catheter includes a plurality of tubes nested in one tube within another tube. The hook 34 is carried by a shaft 36, which is extendable from the interior bore of a hollow carrier tube 38 carrying the implant 30 and / or the shaft 36 is retractable (retracted) to the interior bore. The carrier tube 38 itself is slidable in the hole of a pusher tube 40. In this example, the implant 30 has the form of a narrow-bore elongate coil. In the non-expanded configuration, the coil mounted on the outside of the carrier tube 38 remains in a widened state. When released, the coil self-contracts to its narrow-bore, expanded state.

[0166] When using ( Figure 3a ), the catheter 32 is advanced to the target site near the native chordae tendineae 20 to be shortened, and the hook 34 is extended to hook the native chordae tendineae 20. The hook 32 is retracted ( Figure 3b ) to turn a portion 20a of the hooked tendon 20 toward the carrier tube and finally into the carrier tube 38 ( Figure 4 ). The relative contraction of the carrier tube 38 and / or the advancement of the push tube 40 gradually pushes the coil implant 30 away from the free end of the carrier tube 38 and onto the chordal portion 20a.

[0167] refer to Figure 5 , the implant coil 30 contracts toward its narrow bore configuration, thereby clamping the chord portion 20a therein. A portion 20b of the chord forms a free loop at one end of the coil implant 30, but the majority of the chord portion 20a is captured (restricted) in a circuitous hairpin path defined by the bore of the coil implant 30. The clamping force is distributed over a relatively long majority of the chord portion 20a.

[0168] refer to Figure 6 A second embodiment of the implant 30 similar to the first example includes a self-closing clip that captures at least a majority, and optionally substantially all, of the diverted chord portion 20a within its interior. The interior also defines a circuitous path in the form of a hairpin.

[0169] Despite Figure 5 and Figure 6 In the embodiment, the implant has a substantially straight configuration, but reference Figure 7, a third example of the implant 30 can have a curved configuration to define a wavy and / or tortuous path within the implant 30. The tortuous path can provide a longer circuitous path length and thus increase the shortening effect of the implant 30, as well as help prevent the chord portion 20a from sliding out of the implant 30.

[0170] Figure 8 and Fig. 9 Shows something like Figure 7 A fourth example is shown, except that the implant 30 has a buckle profile through which the native chordae tendineae can be pulled. Figure 8 and Fig. 9 The folded chordae tendineae are shown to be pulled through to create a double pass. Figure 4 The same principles shown in FIG. 4 are used to connect the button implant 30 to the chordae tendineae.

[0171] Figure 10-12 A fifth example of an implant 30 is shown, wherein a hook 34 forms part of the implant. The implant comprises, for example, a (e.g., continuous) wire mesh 44 made of a shape memory material. The hook 34 is integrally mounted to one side, and a handle or grip 46 in the form of a second hook is typically mounted oppositely (at an opposite location) (shown as an example herein, but other connection / disconnection principles may be used). The handle (e.g., second hook) 46 enables the implant 30 to be connected to and manipulated by the catheter 32. Alternatively, the implant comprises a continuous filamentary loop.

[0172] In its natural expanded configuration ( Fig.10 ), the wire mesh and / or wire loop defines a cup and / or channel 48 around the hook 34, wherein the hook 34 is generally located at the base of the cup / channel 48. The second hook 46 can optionally be received in a smaller recess 50 ( Fig.12 and 13 ).

[0173] In use, the implant 30 opens to a substantially low-profile, elongated, undeployed configuration ( Fig.11 ), wherein the implant is delivered to the target site by a catheter (not shown). For example, the implant 30 is constrained in a non-expanded configuration by a constraining sheath. In the non-expanded configuration, the hook 34 is exposed to hook onto the native chordal portion 20a.

[0174] refer to Fig.12When the restraining sheath is removed, the implant 30 returns to its expanded configuration, thereby expanding and / or folding around the hook 34 and pulling the native chord portion 20 to divert the chord portion 20a into the lumen of the channel 48, thereby shortening the functional length of the chord 20.

[0175] Fig.13 A sixth example is shown which is similar to the fifth example, but in which the wire mesh and / or wireform 44 has a more streamlined or curved shape folded around the hook 34 and defines a narrower and more rounded mouth of the channel 48. Fig.12 and Fig.13 and the following Figure 14-15 In , the details of the mesh are omitted to avoid cluttering the figure.

[0176] Fig.14 and 15 A seventh example is shown which is similar to the fifth and sixth examples above, but in which the hook 34 has a three-dimensional profile. For example, the hook 34 provides a concave hook-shaped groove in the lateral and / or transverse direction to allow for lateral / lateral hooking of the chordae tendineae ( Fig.14 In addition, the hook 34 has a convex profile in the vertical direction to define a curved hub surface 52 ( Fig.15 Alternatively, hook 34 can be configured to extend from the implant 30 to the non-deployed configuration ( Fig.14 ) becomes an expanded structure ( Fig.15 ) when the configuration is changed. The hook 34 has arms that close to form a curved hub surface 52 around which the deviated chord portion 20a extends and around which the wire mesh and / or wire form 44 of the implant 30 is folded. By using the curved surface 52, the circuitous path around the hub can be extended compared to a straight hairpin path. In addition, the chords are clamped on a relatively long contact surface. In addition or alternatively, with Figures 10 to 13 The central portion of hook 34 may be made thicker than the hook of FIG. 1 to achieve a similar effect.

[0177] Figure 16-18 An eighth example of an implant 30 is shown, which includes a hook 34 similar to the sixth example hook, which has a three-dimensional profile and / or is configured to change configuration to a curved hub surface 52 when the implant is deployed. A coiled shell 54 extends from the hook / hub surface 52 and forms a cup around the hook / hub surface 52 to define a circuitous deviation path (circumventive deflection path) for a portion of the native chordae tendineae.

[0178] like Fig.16As shown, in the non-expanded configuration of the implant 30, the coiled shell 54 is drawn proximally away from the hooks 34 to an everted condition 54' and is captured within the sheath of the delivery catheter 32. The hooks 34 are exposed to aid in hooking onto the native chordae tendineae.

[0179] like Fig.17 As schematically shown, when the everted coil 54' is released from the sheath, the coil 54 returns distally to its original configuration. Fig.18 , the coil 54 forms a cup around the hook 32 / hub 52 and clamps the native chordae tendineae in a circuitous path extending around the curved surface of the hub 52.

[0180] Figure 19-21 A ninth example of an implant 30 is shown that includes a hub 52 connecting first and second arms 56 carrying lobes or posts 58. Fig.21 It can be seen that the transverse dimensions of the hub 52 and the leaves / fingers 58 are greater than the transverse dimensions of the arms 56 to define a surface on which the native chordae are guided in a circuitous path. In the non-deployed configuration, the arms 56 are pulled proximally away from the hub 52 into a delivery catheter sheath (not shown), allowing the hub 52 to hook around the native chordae 20. When the implant is released, the arms 56 are folded relative to the hub 52, for example, folded around the hub 52, so that the posts 58 divert the native chordae in a circuitous path around the hub 52. The implant also includes a second hook 46 similar to the previous embodiment.

[0181] Figure 22-25 A tenth embodiment of an implant 30 is shown, which includes first and second pivoting members (pivoting parts) 60 and 62 controlled by an actuator 64 of a delivery catheter 32. The first and second members 60 and 62 are arranged to be nested one within the other and have matching curved profiles to define a circuitous path between them around the tip of the inner member. The inner member acts as a curved head around which the outer member can pivot. In the non-deployed configuration of the implant 30, in order to deliver to the target site ( Fig. 22 ), the outer member (e.g., the second member 62) is pivoted open away from the inner member to allow a portion of the native chordae tendineae to enter between the two members. By actuating the implant 30 into the expanded configuration ( Fig.23 and 24 ), the outer member pivots into close engagement with the inner member, thereby diverting the tendons along a circuitous path defined between the two members 60 and 62. The first and second members 60 and 62 may be maintained in the expanded configuration by any of the following means: friction; and / or resilient bias (e.g., Fig. 22After the implant 30 has been connected to the native chordae tendineae 20, the delivery catheter 32 is detached from the implant and retracted ( Fig.25 ).

[0182] Figure 26-28 An eleventh embodiment of an implant 30 is shown, which includes first and second limbs 70 and 72 that pivot relative to each other about a transverse hinge axis 74. The limbs 70 and 72 and / or the trapping fingers 76 carried by the limbs 70 are also folded in a longitudinal direction generally perpendicular to the hinge axis 74 to define a clamping channel for receiving the native chordae tendineae 20. Once clamped, the first and second limbs 70 and 72 pivot closed like jaws to define a multi-fold clamp ( Fig.28 ), thereby defining a generally hairpin-shaped circuitous path. The implant 30 may be maintained in an expanded configuration by any of the following means: friction; and / or a resilient biasing member (not shown); and / or a locking mechanism (not shown).

[0183] Fig.29 and 30 A twelfth embodiment of an implant 30 and delivery catheter 32 is shown, which is similar in some respects to the first embodiment (FIGS. 3-5). The implant 30 comprises a self-contracting tube or coil configured to be extended from an expanded state for delivery ( Fig.29 ) self-contracts into a collapsed configuration (30), wherein the tube accommodates a portion of the native chordae tendineae 20 in a hairpin shape. In addition, the delivery catheter 32 includes a hook 34 that is extendable to hook onto the native chordae tendineae 20 ( Fig.29 ) and is retractable to pull the native chordae tendineae proximally into the implant 30.

[0184] However, the twelfth example has other features. Fig.29 , no carrier tube is required to hold the implant 30 in its expanded configuration for delivery, instead the implant 30 is directly supported (supported) by the shaft 80 on which the hook 34 is mounted. The dimensions of the shaft 80 are designed to hold the implant 30 in its expanded, non-expanded configuration for delivery. The shaft 80 is extendable to expose the hook 34, and is retractable to pull the hook 34 into the interior of the catheter 32. The catheter 32 also includes a stop to axially limit the implant 30 during movement of the shaft 80, despite the friction between the implant 30 and the shaft 80. In this example, the distal stop includes an inwardly turned lip 82 of the outer cover tube 84, and the proximal stop includes a blocking end surface 86 of the intermediate tube 88 (the shaft 80 slides inside it).

[0185] In use, the shaft 80 is extended to expose the hook 42 for hooking the native chordae 20. Then, the shaft 80 is retracted to pull the native chordae into the interior of the catheter 32. Once the shaft 80 and hook 42 have cleared the implant 30, the implant 30 is free to retract to its expanded configuration ( Fig.30 ) to connect around a portion of the native chordae that has been pulled through the implant. The expanded configuration has a smaller diameter, wherein the implant is no longer constrained by the edge 82 and is therefore free to separate from the catheter 32. The catheter 32 can be withdrawn (removed) from the expanded implant 30, or the shaft 80 can be advanced distally to eject (eject) the implant 30 using the hook 34 as a pusher.

[0186] Another feature of the implant 30 of this example is the provision of a self-expanding protrusion 90 (eg, to act as a retainer). Fig.29 ), the protrusions 90 are folded into the wall of the implant 30. In the deployed configuration ( Fig.30 ), the protrusion 90 is deployed toward and / or through the internal passage of the implant 30 to define a surface behind the tight bend of the native chordae tendineae 20, thereby retaining the pulled-in portion of the chordae tendineae 20, and / or preventing the native chordae tendineae 20 from being pulled out of the implant once the protrusion 90 is deployed. In the illustrated example, the protrusion 90 extends diagonally from one end. In alternative embodiments, the protrusion can swing more laterally from the opposite end.

[0187] Fig.31 A thirteenth example similar to the twelfth example above is shown. The main difference is that the catheter is configured to accommodate multiple implants 30 loaded in a straight line (side by side with each other) at the tip. The implant 30 is deployed by manipulating the shaft 80. For example, multiple implants 30 can be connected to the same native chord 20 by fully retracting the shaft 80 proximally to clear (remove, release, clear) the appropriate number of implants 30 to be deployed together. Alternatively, each implant 30 can be deployed individually by only retracting the shaft 80 to the extent of clearing the most distal implant 30. The most distal implant 30 is retracted onto the chord 20 and separated from the catheter 32, while the other implants 30 are stored in the catheter 32 and maintained in a non-deployed state by the shaft 80. A spring-biased pusher 92, such as a coil spring, pushes the implant 30 distally to replace the deployed implant at the tip to prepare for subsequent deployment. This catheter 32 allows multiple implants 30 to be connected without having to retract and reinsert the catheter each time. Such a multi-application catheter 32 may greatly increase versatility of use and reduce the duration and invasiveness of the procedure.

[0188] Figure 32 to Figure 36A fourteenth example similar to the tenth example above is shown, wherein the implant 30 includes complementary first and second components 100 and 102 having curved profiles to define a circuitous path between them. In this example, the first and second components 100 and 102 are slidably movable relative to each other. The spring 104 biases the components 100 and 102 toward each other into an expanded configuration, thereby capturing a portion of the native chordae tendineae 20 between the components 100, 102 ( Fig.35 ).

[0189] One component 102 includes a handle 46 in the form of a nipple, which can be gripped by the jaws 106 of the catheter 32, and a through hole 108 through which a push rod 110 of the catheter 32 can be advanced to push the components 100 and 102 away from each other. The other component 100 optionally includes a slot 112 for receiving the tip of the push rod 110. The through hole 108 is aligned with the center of the nipple 46. The catheter 32 includes an outer sleeve 114, and a hollow tube 116 carrying the jaws 106 is slidable in the outer sleeve 114. The jaws 106 are biased open, but by retracting the tube 116 relative to the sleeve 114, the jaws 106 are closed inwardly so that the nipple 46 can be gripped by the catheter 32 until the implant 30 is ready to be released.

[0190] The push rod 110 is slidable in the hole of the tube 116. In use, by advancing the push rod 110, while keeping the tube 116 contracted to grasp the nipple 46, the parts 100 and 102 of the implant are pushed away from each other against the bias of the spring 104. In order to connect the implant 30 to the native chord 20, the parts 100 and 102 are hooked around the native chord 20 and the push rod 110 is contracted. The spring 104 pulls the parts 100 and 102 toward each other to capture the native chord 20 in a circuitous path between the curved contours of the parts 100 and 102. If the operating physician wishes to adjust the position of the implant 30, this is possible when the implant 30 is still connected to the jaws 106. The push rod 110 can be advanced again to open the parts 100 and 102 and allow repositioning. Once the implant 30 has been properly positioned and securely attached, the tube 116 can be advanced to allow the jaws 106 to spring open and release the implant's nipple 46. Thereafter, the catheter is withdrawn.

[0191] By comparison Fig.32 and Fig.35As best seen, in the illustrated example, components 100 and 102 define a bubble or spherical shape. Components 100 and 102 can be bent around each other in different directions (e.g., generally vertical directions), for example, in a manner similar to the curved surface profile of a tennis ball, or in a manner similar to a person crossing his or her palms together. When components 100 and 102 are brought together, this form can help components 100 and 102 self-align (self-alignment), while also providing a smooth outer surface. It can also provide complementary hook-type surfaces on both components 100 and 102, which work in different directions. In other examples, the components 100 and 102 can have more male-female configurations, so that one component 102 fits into the convex hollow of another component 100.

[0192] In the fourteenth example, the opposing surfaces of the first and second components 100 and 102 are generally smoothly curved with a large radius of curvature, defining a circuitous path.

[0193] Fig.37 A fifteenth example is shown in which the opposing surfaces have interlocking and / or toothed profiles. Such profiles increase the length of the circuitous path by additional meandering compared to a smooth profile. In addition or as an alternative, the profiles may define a snap-fit. The snap-fit ​​may be due to the angles of the teeth not all being aligned with the direction of motion. Alternatively, some teeth may be configured to be oversized relative to the mouth of the opposing groove, thereby forming a snap when the teeth enter the groove. The snap-fit ​​may add an additional degree of security to the connection already provided by the spring 104.

[0194] Figures 38 to 49 Another example using a retainer 90 similar in function to the retainer of the twelfth embodiment described above is shown. Implant 30 includes a collar (or sleeve or tubular) body 120 having a mouth 122 at one axial end and retainer 90. Figures 38 to 42 In the sixteenth example shown, the retainer 90 is disposed at the axial end of the body 120 opposite to the mouth 122. This configuration can enable a relatively short implant body. Figure 43 to Figure 49 In the seventeenth to twentieth examples, the retainer is disposed at an intermediate (intermediate) position between the axial ends of the main body 120. This configuration enables the retainer 90 to be covered by the main body 120 and, if necessary, avoids exposure of the retainer 90.

[0195] In these examples, the retainer 90 may include one or more protrusions that protrude inwardly (e.g., radially inwardly), or are bent or inclined from the wall of the body 120. In the current example, the protrusions are formed integrally (integrally) with the wall of the body. Integral forming can help manufacturing and compact size. However, in other embodiments, the retainer can be separated / independent from the body 120. (One or more) protrusions can be elastically biased inwardly (e.g., self-biased) and can be temporarily displaceable outwardly to allow the hook 34 and the tendon to pass through. For example, (one or more) protrusions can be folded back into the gap in the wall of the body 120. The elastic bias can avoid the need for external influence to move the protrusions inwardly. In other examples, using an externally applied deformation force, (one or more) protrusions can be plastically deformed to move from an outward configuration to an inward protruding configuration.

[0196] When using, refer to Fig.40 , Fig.44 and Fig.46 , the catheter hook 34 (as previously described) is positioned to extend through the implant body 120, or extends through the implant body 120. For example, by pushing outward against its resilient bias, the retainer 90 can be displaced outward to accommodate the passage of the hook 34. The device is manipulated to engage the target chordae tendineae with the hook 34. While the body 120 is restrained by the catheter 32, the hook 34 is retracted (e.g., Fig.41 ) Pull a portion of the tendon through the mouth 122 of the body 120 and into and / or through the internal space defined by the body 120 to reach the retainer 90.

[0197] The retainer 90 is used to prevent the pulled-in (or pulled-through) portion of the tendon 20 from being pulled out through the mouth 122 when the hook 34 is disengaged from the tendon and removed (e.g., Fig.42 and Fig.45 ). The chordae tendineae 20 pass around the protrusion(s) and a sharp bend in the chordae tendineae is retained behind the protrusion(s).

[0198] The retainer may optionally include a single protrusion 90 positioned toward the mouth 122 of the implant body 120 or toward an opposite end of the implant body 120 (eg, Fig.48 and Fig.49 ). A single protrusion is sized to extend substantially across the space defined by the body 120. Alternatively, the retainer may include a plurality of protrusions (eg, first and second protrusions 90a, 90b, e.g., Fig.38 and 39). The protrusions 90a, 90b together define an obstacle in or across the space defined by the body 120 shown. Where two protrusions 90a and 90b are used, the protrusions may together extend substantially along a diameter. Where three or more protrusions (not shown) are used, the protrusions may together form a star shape (e.g., a tristar configuration).

[0199] Optionally, the distal ends of the plurality of protrusions 90a and 90b may have mutually mating profiles 124a and 124b to guide each other and / or enhance engagement between the distal ends of the protrusions. For example, the mutually mating profiles may include male and female profile shapes.

[0200] Regardless of how many protrusions are used, the protrusions may generally be straight, or curved, or otherwise bent along their extension. The curved shape may avoid stress concentrations, and / or increase the strength and resilience of the protrusions.

[0201] The hook 34 may have any desired form. Figure 38-47 Two preferred forms are shown in Figures 38 to 45 In the embodiment, hook 34 has a relatively thin profile, such as a wire hook. The thinner profile avoids the need for significant displacement of the retainer, and for some implementations, this may be preferred. Fig.46 and Fig.47 In the embodiment of the present invention, the hook 34 has a thicker crochet-hook profile. The crochet-hook profile has an atraumatic nose and a generally uniform diameter, thereby reducing exposure of the free edge of the hook, which may be advantageous in some embodiments. Other examples of hooks are described subsequently.

[0202] The orientation of the hook 34 relative to the retainer 90 can be selected to (i) help the hook pass through the retainer 90, and / or (ii) help the retainer engage the hooked chordae. For example, the hook 34 can be oriented with a principal plane parallel or perpendicular to the axis of the retainer 90.

[0203] The configuration of the retainer 90 described above can also be used in the twelfth example to directly replace the protrusion 90 of that example.

[0204] In the sixteenth to twentieth examples described above, the retainer 90 of the implant 30 is different from the hook 34 used to pull the chord into and / or through the implant 30, for example, the hook 34 is part of the catheter, not part of the implant. In contrast, the twenty-first and twenty-second examples described below show the hook 34 also acting as a retainer that is part of the implant 30. The implant can therefore include the hook 34 and the body 120, optionally as two separate elements.

[0205] In more detail, in the twenty-first and twenty-second examples, the hook element 34 is connected to the manipulation shaft 36 of the delivery catheter 32 via a detachable coupling 126. Figure 50-52 In the example of , the removable connector 126 is formed by interengaging profiles held together by a relatively tight fitting outer sheath 38. When the outer sheath 38 overlaps an area of ​​the connector, an applied force (e.g., axial force and / or torque) can be transmitted from the shaft 36 to the hook 34. Contraction of the outer sheath 38 allows the hook 34 to be separated (e.g., permanently separated) from the shaft 36. Figure 53-55 In the example of , the threaded connection forms the removable connector 126. The retractable outer sheath 38 prevents accidental unscrewing of the removable connector 126 until the outer sheath 38 is retracted. Other types of removable connectors (such as jaws and nipples; or hooks) are also described herein.

[0206] The location of the removable connection 126 is shown to be on one side of the hook 34, but this is by way of example only and depends on the type of hook 34 used. For example, in the case of a crochet type of hook 34, the removable connection may be towards the center.

[0207] The hook element 34 is initially positioned in front of the mouth 122 of the implant body 120. For example, the hook element 34 can be pre-positioned in front of the mouth 122. Alternatively, for example, the body 120 can be initially axially separated from the hook 34 and advanced toward the hook element on the shaft 34 when appropriate. In a manner similar to that described above, after the hook has been positioned to engage the native chordae tendineae, the hook 34 is retracted relative to the body 120 by relative movement therebetween (e.g., by pulling and / or advancing the body 120 backward on the shaft 36). Thus, the hook element pulls a portion of the chordae tendineae into a circuitous path inside the body 120.

[0208] The retaining mechanism 128 allows the hook element 34 to be retracted into the body 120, but prevents the hook element 34 from being pushed out of the mouth 122, thereby preventing the pulled-in portion of the tendon cord from being pulled out. The retaining mechanism 128 may include a ratchet (ratchet) structure that allows one-way relative movement between the hook element 34 and the body 34, while preventing relative movement in the opposite direction. Figure 50-52 In the example shown, the retaining mechanism includes a barb 128a on (at least) one of the hook element 34 and the body 120, the barb 128a protruding in one direction to embed into the opposing surface, thereby achieving one-way relative movement. Figure 53 to Figure 55In the example shown, the retaining mechanism 128 includes one or more stoppers 128b formed on (at least) one of the hook element 34 and the body 120, which engage with a protrusion 128c formed on (at least) the other of the hook element 34 and the body 120. The protrusion 128c is configured to pass over the stopper 128b and be caught behind it.

[0209] Once the hook element 34 is pulled to the desired position within the body 120 and retained by the retaining mechanism 128, the hook 34 can be detached from the catheter 32. The implant 30 consisting of the hook 34 stuck in the body 120 remains connected to the native chordae tendineae, and the catheter 30 is removed.

[0210] The retaining device 128 can define a single position at which the hook element 34 is retained, or it can define a plurality of possible retaining positions. The plurality of retaining positions can be any of: for example, predetermined positions defined by a plurality of different axial positions of the stop 128c; or, for example, variable positions defined by the barbs 128a, which can be embedded in any position along the relative surface. Based on the implementation, a single retaining position may be preferred in order to simplify implantation and / or achieve an axially short body 120, and / or achieve a uniform degree of shortening. For implementations that allow the operator to select or control the degree of shortening achieved by a single implant, multiple retaining positions may be preferred.

[0211] Figure 56-63 Shown are twenty-third and twenty-fourth examples, wherein hook element 34 (also referred to as retractor element) is used as the retainer of implant. In these examples, retractor element 34 is configured to expand and / or open to a larger size than the internal space of implant body 120, for hooking native chordae tendineae, and close and / or contract to a smaller size for entering and / or passing through implant body 120.

[0212] The retractor element 34 includes first and second jaws (jaws) 130a, 130b connected (eg, hinged) together at one end. Fig.57 and Fig.61 ), the jaws 130a and 130b define an open hook configuration for hooking native chordae tendineae. In a closed configuration (e.g., Fig.58 , 5962), the jaws 130a, 130b define a closed hinge or retractor structure for pulling the chord into and / or through the implant body 120. At least one of the jaws 130a, 130b can optionally have at least one groove 132 for guiding the chord through when the jaws are closed. Initially, the retractor element 34 is connected to the first and second shafts 36 and 38 of the catheter. One shaft can hold the retractor element 34, while the other shaft can change the configuration of the retractor element.

[0213] exist Figure 56-60 In the example of, the jaws 130a and 130b are biased closed. The catheter shaft 36 is configured to open the jaws by applying pressure to at least one jaw by advancing from the inside. After hooking the native chordae, the shaft 38 is retracted to allow the jaws to close and capture the chordae. The retractor element 34 and the implant body 120 move relative to each other to pull the retractor element 34 and the chordae from one side of the implant body to the other side. Before being detached from the catheter, the retractor element 34 rotates or is rotated to extend laterally to the implant body 120, thereby capturing the retractor element 34 by being pulled through the chordae of the implant body in a circuitous path in a manner similar to a transverse pledget.

[0214] exist Figures 61 to 63 In the example of the embodiment of the present invention, the jaws 130a, 130b are biased open and initially retained within the sleeve of the catheter shaft 38. When released from the sleeve, the jaws 130a, 130b diverge open to form an open hook. The jaws 130a and 130b are controlled by the tension in the control cable 36, which can retract the jaws 130a and 130b in response to the applied tension. Once the tendon cord has been hooked by the jaws, the jaws 130a and 130b are retracted and closed, and the retractor element 34 is pulled from one side of the implant body 120 to the other side in a manner similar to that described above. Once released from the catheter, the jaws 130a and 130b are elastically opened to define a lateral configuration, thereby capturing the retractor element 34 and the tendon cord that has been pulled through the implant body 120.

[0215] Figures 64 to 67 Other configurations of hook and / or retractor elements 34 are shown that may be used in any of the above embodiments where appropriate. Fig.64In the twenty-fifth example, in a hook-like manner, the hook element 34 includes a shaft 140 having an atraumatic tip 142 and a receiving cavity 144 near the tip 142. The cavity 144 has a tapered profile at at least one end, optionally at both ends. When the cavity 144 is open, the tapered profile allows the chordae tendineae to be released from the cavity 144 substantially unimpeded. The movable door portion 146 is displaceable to extend at least partially through the mouth of the cavity 144. The movable door portion 146 can, for example, have a relatively narrow strip or wire form that slides in a channel 148 within the shaft 140. For example, the advancing wire advances the door portion 146 through the mouth of the cavity 144; the retracting wire retracts the door portion. In this example, the door portion 146 can protrude from the distal end of the shaft 140 and can be retracted into the distal end of the shaft 140. This enables the element 34 to define a hook structure for hooking native chordae tendineae in a manner similar to the examples described above. This is aided by a channel 148 extending in a U-shape within the tip 142. The wire or strip has sufficient flexibility to follow the U-shaped path while maintaining sufficient stiffness to provide an effective gate portion 146 at its exposed end. The wire or strip may be pre-shaped so that after passing through the U-shaped path, the wire returns to a straight configuration. For example, the wire or strip may be a shape memory material, such as a Nitinol alloy.

[0216] As a modification of the above, the tip 142 may be omitted and, instead, the shape of the hook may be defined by a preformed strip or wire 146 that is advanceable from the shaft 140 and adopts its own U-shape once it is freed from the shape of the channel 148. As described above, the wire or strip may be made of a shape memory material, such as Nitinol.

[0217] Fig.65 A twenty-sixth example is shown that is similar to the twenty-fifth example, except that an additional sheath or sleeve 150 is slidable relative to the shaft to at least partially cover the cavity. A stop 152 can limit the extent to which the sleeve 150 can be advanced over the cavity. Despite the presence of the housing cavity 144, the sleeve can enable the retractor 34 to have a more uniform outer dimension (e.g., diameter).

[0218] Fig.66 and 67Shown is the twenty-seventh example, in which the hook element 34 is made of a flexible coil or a segment connected together. The coil / segment defines a hollow flexible body (hollow flexible body) or assembly (assembly), which, for example, can have a generally straight structure when relaxed, or a loosely curved structure. A tensioning member 154 extends in the body (and / or optionally outside the body) and is connected to one or more segments or coil loops. When tension is applied via member 154, the segment or coil loop is squeezed and adopts a predetermined hook shape. For example, the tensioning member 154 is connected to one side of the segment or coil loop to cause squeezing on the side to form an inner curvature of the hook shape without hindering the outer curvature of the hook shape formed on the other side. In the form shown, the segment or coil loop has a uniform cross-sectional size and shape. However, in other forms, the segments or coil loops may have an asymmetric form that is thinner on one side and / or that facilitates relative assembly into a curved shape when the segments or coil loops are pushed closely relative to each other.

[0219] Fig.68 and 69 A twenty-eighth embodiment is shown in which the implant 30 includes a hook element 34 in the form of a circular, e.g., generally cylindrical, hub 160 defining a waist region between enlarged ends or ridges 162. The hook element 34 is connected to a catheter shaft 36 by a removable connector (not shown), e.g., which may be similar to the removable connector 126 described above. A female gripping element 164 is pushable on the shaft 36 toward the hub 160 by a pusher shaft 38. The gripping element 164 is configured to form a resilient snap fit around the hub 160.

[0220] In use, the hub 160 is positioned spaced from and in front of the clamp 164. The hub acts as a hook element 34 for hooking the native chordae tendineae. Once hooked, the ridges 162 stabilize the chordae tendineae on the hub 160, thereby preventing the chordae tendineae from slipping off. The shaft 36 is then retracted, and / or the shaft 38 is advanced to move the clamp 164 and the hub 160 relative to each other until the clamp 164 is clamped around the hub 160 to hold the chordae tendineae in a generally curved circuitous path around the hub 160 (e.g., Fig.69 ). Thereafter, the catheter shaft is detached from the hub 160 and the clamp 164, leaving the assembled implant in place.

[0221] Although in this example, the clamp 164 is biased to form a snap fit around the hub 160, in other examples, the clamp 164 may initially be larger than the hub 160 and may be plastically deformed around the hub 160, such as by jaws of a catheter (not shown).

[0222] Figure 70-72 A twenty-ninth example is shown, which also includes a hub 160 and a concave clamping surface 164. In this example, the concave clamping surface 164 is permanently connected to one end (e.g., distal end) of the hub 160 by a connecting arm 166. The hub 160 is moved from an expanded configuration (e.g., Fig.71 ) is reversibly contractible into a contracted configuration (e.g., Fig.70 ). In the contracted state, the hub 160 is spaced apart from the clamping surface 164, thereby leaving a gap 172 for hooking the native chordae tendineae 20. When the sheath 170 is contracted to expose the hub 160, the hub 160 can be expanded into an expanded configuration. For example, the hub 160 can be self-expanding and made of an elastic material. The material can be, for example, a shape memory material, such as Nitinol alloy. The hub 160 can optionally have a wire frame structure to facilitate contraction and expansion.

[0223] In an extended construct (e.g., Fig.71 and 72 ), the hub 160 expands toward the concave clamping surface 164, and optionally expands against the concave clamping surface 164, thereby clamping the native tendon in a circuitous path between the hub 160 and the clamping surface 164.

[0224] Although in the present example, the hub 160 is self-expanding from a collapsed configuration, in other examples, the hub 160 may be made of a plastically expandable material and the catheter may include a forcible expansion member, such as an inflatable balloon, for plastically expanding the hub 160 .

[0225] Figures 73 to 75 A thirtieth example is shown, in which the implant 30 includes a hollow staple 180. Fig.73 , the staple 180 may initially have an open channel shape, for example, a circular channel base 182, and a protruding wing 184 located at the channel mouth. In addition or alternatively, the staple may initially be substantially straight. Such a configuration allows the native chordae 20 to easily enter the open staple 180. Thereafter, referring to Fig.74 , the staple 180 is deformed to close the passage and form a curved shape that defines the circuitous path of the chordae tendineae. Other types and shapes of staples 180 may also be used as desired.

[0226] Fig.75A stapler unit 186 integrated at the tip of the delivery catheter 30 is shown for delivering and assembling the staple 180. The stapler 186 has the form of a hook and supports the staple 180 in the hollow portion of the hook shape, wherein the opening of the staple faces the open region of the hook, so that the chordae enter the staple by a simple hooking action. The stapler 186 is configured to squeeze the staple 180 closed, for example, to bend the staple 180 closed, and to deform the staple 180 into a curved shape, for example, assisted by pressure from an inflatable balloon 188. Thereafter, the catheter 30 and the integrated stapler 186 can be removed.

[0227] Figures 76 to 85 Other examples are shown that include a spool element 200 for wrapping a portion of a native chordae at least partially around the spool element 200 .

[0228] Figures 76 to 78 A thirty-first example is shown, in which the implant 30 includes a bobbin element 200 having first and second engagement profiles 202 and 204 (e.g., arms or lugs). In the form shown, the engagement profiles are diametrically opposed to each other. Also in the form shown, the engagement profiles extend from opposite ends of the bobbin element 200 relative to each other. Each engagement profile 202, 204 generally has the form of an elastic S-shaped curve. Each engagement profile 202, 204 is self-biased into such a configuration, in which the engagement profiles together with the surface of the bobbin element 200 define a substantially closed loop around the space 202a, 204a, respectively, and the engagement profile has a free end bent away from the bobbin element 200.

[0229] In use, one engagement profile (eg, arm) 202 is used to apply torque to wind the tendons (at least partially) around the spool element 200, and the other engagement profile 204 is then used to hold the spool in a set rotational orientation relative to the native tendons.

[0230] refer to Fig.78, each engagement profile (e.g., arm) 202, 204 is displaceable and / or can be lifted at least a short distance from the surface of the spool element 200 to allow the native chordae to be guided into the space 202a, 204a defined by the corresponding engagement profile. In this state, the engagement profile can act as a hook element. The delivery catheter 32 may include one or more shafts 206 that abut against the engagement profiles 202, 204 from within the spool element 200 and lift the engagement element as described above. The engagement profile may have a shape that is radially slightly below the level of the surface of the spool element 200 and may be radially displaced outward by one or more shafts that are advanced through the interior of the spool element 200. (One or more) shafts 206 may act together on the engagement profiles 202, 204, or a separate shaft or shaft component may selectively or individually act on the corresponding engagement profile 202 or 204. For example, multiple shafts may be nested together or may extend side by side.

[0231] Fig.78 A technique for implanting a bobbin element 200 is shown. By slightly lifting the first engagement profile 202, the catheter is manipulated to hook the chordae below the free edge of the first engagement profile 202 and enter the space 202a, as indicated by arrow 208. Thereafter, the catheter is manipulated to turn and / or rotate the bobbin element 200, for example, by one or more rotations. The chordae captured by the first engagement element are at least partially wrapped around the bobbin element 200. When the desired degree of chordae shortening has been achieved, the second engagement profile 204 is manipulated to engage and capture the chordae within the space 204a. This stabilizes the bobbin element on the chordae and prevents the chordae from unwinding from the bobbin element 200.

[0232] exist Fig.78 In the example shown, the second engagement profile can optionally be folded back to disengage from the spool element 200. This can reduce the risk of the second engagement profile interfering with the winding of the tendons around the spool element 200. For example, the second engagement profile 204 can be held in the folded back position by a restraining sheath (not shown). When the sheath is retracted, the second engagement profile 204 is free to spring back to its normal position biased toward the spool element 200.

[0233] Although the joining profile is shown as having a generally curved profile, a variety of other shapes of joining profiles may be used as desired.

[0234] Figures 79 to 81 A thirty-second example of an implant in the form of a bobbin element 200 is shown, which includes first and second engagement profiles 202 and 204 having similar functions to those described above. However, in this example, the first engagement profile is biased to a recessed position, such as Fig.79As shown, in this position the engagement profile does not substantially protrude towards the outside of the bobbin element 200 .

[0235] refer to Fig.80 , the delivery catheter comprises a control sheath 210 and an internal push shaft 214 slidable within the sheath 210. In use, the bobbin element 200 is loaded at the distal end of the control sheath, the first engagement profile 202 is aligned with the hole 212 of the sheath, and the second engagement profile 204 is folded back away from the bobbin element 200. The sheath 201 restrains the second engagement profile 204 in the folded back condition.

[0236] To deploy the implant, the push rod 214 is advanced into the interior of the bobbin element 200, thereby forcing the first engagement profile to expand outwardly through the aperture 212 of the sheath (eg, Fig.81 In this configuration, the first engagement profile 202 can be hooked onto the native chord and the assembly rotated one or more times to wrap the native chord at least partially around the spool element 200. Once the chord is shortened by the desired amount, the sheath 210 is retracted, thereby releasing the second engagement profile 204 to fold toward the spool element 200 to its normal position (e.g., Fig.79 ). Then, the push shaft 214 is retracted. The first engagement profile 202 is biased inwardly into the interior of the bobbin element, thereby firmly anchoring the tendon to the bobbin element 200, while the second engagement profile stabilizes the bobbin element relative to the other side of the tendon and prevents the tendon from unwinding from the bobbin element 200.

[0237] In addition to the implementation of the second joining profile 204, Figure 82 to Figure 85 A thirty-third example is shown which is very similar to the thirty-second example described above. Where features are the same or similar, these features will not be described again, but reference may be made to the previous description.

[0238] In the present example, the second engagement profile 204 is a separate element from the bobbin element 200. The second engagement profile 204 is shaped as a clip or clamp, which forms a snap around the bobbin element 200 after the tendon is at least partially wound around the bobbin element 200. The second engagement profile 204 is initially carried outside the control sheath 210, spaced apart from the bobbin element 200. Fig.84 Once the tendons have been shortened by the desired amount, a pusher sleeve 216 pushes the second engagement profile 204 toward the bobbin element 200 until the second engagement profile 204 is clamped around the bobbin element 200 by a snap fit. Fig.85Once assembled to the spool element 200, the second engagement profile 204 firmly anchors the tendon 20 and stabilizes the spool element 200 against rotation relative to the tendon 20. If desired, the second engagement profile 204 may interlock with one or more features of the spool element 200 to define a unitary structure.

[0239] If desired, the spool element 200 of any example can be optionally mounted in a frame or housing (not shown) that remains fixed and rotates therein. This arrangement can provide additional protection for the spool element. The frame or housing can also provide some or all of the functions of the first and / or second engagement profiles 202 and 204. The frame or housing can be used to limit the rotation of the spool element 200, for example, only in the winding direction, and prevent reversal in the unwinding direction.

[0240] In all of the foregoing embodiments, different portions of the conduit 32 may optionally have a fixed rotational alignment. Fixed rotational alignment may be achieved, for example, by mechanical keying, such as non-circular surfaces of the nested components. For example, the nested components may have an elliptical or polygonal (e.g., triangular or square) cross-sectional shape. Alternatively, one or more of the nested components may be rotatable relative to each other when desired.

[0241] While some embodiments show handle 46 on the implant in the form of a hook and other embodiments show handle 46 in the form of a nipple that can be grasped by a jaw, these example forms of handles may be interchanged in any of the above examples and other forms of handles are also contemplated.

[0242] Although not specifically shown in the accompanying drawings, any of the above embodiments may optionally include at least one surface that includes and / or is coated with and / or carries (e.g., as a cushion) a compressible and / or flowable material that is capable of conforming at least partially around the contours of the native chordae tendineae while frictionally engaging the native chordae tendineae. Example materials include silicone, polyurethane foam, and biocompatible rubber. This arrangement can provide a secure yet atraumatic engagement with the native chordae tendineae.

[0243] Fig.86 The steps of a method for treating atrioventricular valve prolapse using an implant, for example, an implant according to any of the above examples are shown. The method comprises one or more or any combination of the following steps:

[0244] Step S1: observing the patient's beating heart using medical imaging (e.g., transesophageal ultrasound imaging, which has been shown to provide good images of valve leaflet motion and valve condition);

[0245] Step S2: determining at least one target treatment feature from the observation results, the target treatment feature being related to shortening of at least one native chord for treating prolapse of one or more valve leaflets of a beating atrioventricular valve (e.g., any one or more of the following: the location of the target chord to be shortened; the degree of shortening of the target chord; the location of the implant to be placed on the target chord; the number of chords on which one or more implants are to be placed; the number of implants to be implanted);

[0246] Step S3: introducing a catheter into a target site in the patient's beating heart for delivery of the implant to the native chordae tendineae, and

[0247] Step S4: operating the catheter to connect the implant to the native chordae tendineae, thereby functionally shortening the native chordae tendineae.

[0248] It will be understood that the above description is only illustrative of preferred examples and that various modifications and equivalents may be used within the scope and principles of the invention.

Claims

1. A device for treating atrioventricular valve prolapse, the device comprising an implant (30) deliverable via a catheter (32), the implant being configured to connect to native chordae tendineae (20) and shorten the functional length of the native chordae tendineae.

2. The device according to claim 1, wherein the implant (30) is connectable to a single native chord (20) and is configured to shorten the functional length of the corresponding single chord.

3. The device according to any preceding claim further comprising a catheter (32) for delivering the implant to a target site in the heart, and a hook (34; 52) configured to hook the native chordae tendineae.

4. The apparatus of claim 3, wherein the hook is configured to pull the native chordae in a proximal direction relative to the catheter.

5. The apparatus of claim 3 or 4, wherein the hook is configured to pull the native chordae tendineae through the mouth of the implant and into the interior space of the implant.

6. The apparatus of claim 3, 4 or 5, wherein the hook is configured to pull the native chordae tendineae from within the implant, optionally from an interior space of the implant for accommodating the native chordae tendineae.

7. A device according to claim 3, 4, 5 or 6, wherein the implant includes a body having a first region and a second region, the first region having a mouth, the second region having an opening opposite to the mouth, and the hook is configured to pull the native tendon toward the second region through the mouth.

8. The apparatus of claim 7, wherein the hook is configured to pull the native chordae tendineae through the opening in the second region.

9. Apparatus according to any one of claims 3 to 8, further comprising a retainer for preventing the pull-in region of the chordae tendineae from being pulled out of the implant, optionally wherein the retainer is distinct from the hook.

10. Device according to any one of claims 3 to 9, wherein the hook (34; 52) is positioned internally with respect to a portion of the implant (30).

11. Device according to any one of claims 3 to 10, wherein the hook (34; 52) moves inside a portion of the implant (30).

12. Device according to any one of claims 3 to 11, wherein the hook (34; 52) forms part of the implant (30).

13. Apparatus according to any one of claims 3 to 12, wherein the hook (34) forms part of the conduit (32).

14. A device according to any one of claims 3 to 13, wherein the hook (34) is configured to change its structure between any two of the following structures: a hooking structure for hooking native tendon chordae; a releasing structure for allowing release of the tendon chordae; a contracting structure having a relatively small transverse profile; an expanding structure having a relatively large transverse profile.

15. Apparatus according to any preceding claim, wherein the implant (30) is configured to divert a portion of the native chordae tendineae along a circuitous path, at least a majority of which is defined by the implant.

16. The apparatus of claim 15, wherein the implant (30) defines substantially the entirety of the circuitous path along which a portion of the native chordae tendineae is diverted.

17. The apparatus of any preceding claim, wherein the implant (30) is configured to change configuration between a non-deployed configuration for delivery to a target site in the heart and a deployed configuration for connection to native chordae tendineae.

18. The device according to claim 17, wherein the implant (30) comprises a first part (34; 52; 60) and a second part (44; 54; 56; 58; 62), the second part being configured to unfold and / or fold around the first part when the implant is changed from the non-expanded structure to the expanded structure.

19. The device according to claim 17 or 18, wherein the implant (30) is configured to squeeze the native chordae tendineae and / or squeeze around the native chordae tendineae when the implant is changed from the non-deployed configuration to the deployed configuration.

20. A device according to any preceding claim, wherein the implant (30) includes a clamping surface, optionally an extended clamping surface, configured to provide distributed clamping contact along the native chordae tendineae, the clamping surface being any one or more of: curved; straight; curvilinear; meandering; defined by interlocking teeth.

21. A device according to any preceding claim, wherein the implant (30) comprises a curved surface (52; 60) configured to define an at least partially curved, optionally at least partially serpentine, circuitous path of the native chordae tendineae.

22. Apparatus according to any preceding claim, wherein the curved surface (52; 60) is configured to define a substantial portion of the circuitous path as a curved path.

23. Apparatus according to any preceding claim, wherein the implant comprises a bobbin element for at least partially winding a portion of the native chordae tendineae around it.

24. The apparatus of claim 23, wherein the spool element is configured to rotate about a spool axis.

25. Apparatus according to claim 23 or 24, wherein the spool comprises an engagement profile for applying a winding torque to the native chord for winding the chord at least partially around the spool.

26. The apparatus of claim 23, 24 or 25, further comprising a second engagement profile for maintaining the spool in a set rotational orientation relative to the native chordae and / or relative to a non-rotational portion of the implant.

27. Apparatus according to claim 25 or 26, wherein at least one engagement profile comprises a resiliently biased lug.

28. An apparatus according to any preceding claim, wherein the implant is configured to pull a portion of the native chordae into and / or through a portion of the implant and / or at least partially around a portion of the implant, the degree of shortening of the functional length depending on, and optionally being the same as, the length of the portion pulled into and / or through and / or around the portion pulled.

29. A device according to any preceding claim, configured to provide different degrees of shortening of the functional length of the native chordae tendineae, the degrees of shortening corresponding to the length of the native chordae tendineae pulled into and / or through the implant and / or around the implant.

30. The apparatus of claim 29, wherein the implant has a plurality of settable configurations, each configuration providing a corresponding degree of shortening of the functional length of the native chordae tendineae.

31. A method of treating an atrioventricular heart valve, the method comprising introducing an implant into a target side of the heart using a delivery catheter, and connecting the implant to native chordae tendineae to functionally shorten the native chordae tendineae.

32. A method according to claim 31, wherein the connecting step includes manipulating the implant to at least partially pull a portion of the native chord into and / or at least partially pull through a portion of the implant and / or at least partially pull around a portion of the implant.

33. The method of claim 32, wherein the degree of shortening corresponds to the length of the portion of the native chordae tendineae.

34. A method according to any one of claims 31 to 33, wherein the connecting step comprises connecting to a single chordae tendineae.

35. The method of any one of claims 31 to 34, wherein the connecting step comprises pulling a hooking element to pull the native chordae relative to a portion of the implant.

36. The method according to any one of claims 31 to 35, further comprising the following steps at least before the connecting step: Using medical imaging to observe the patient's beating heart, At least one target treatment feature associated with shortening of at least one native chord is determined based on the observations for treating prolapse of one or more leaflets of an atrioventricular valve of the beating heart.

37. A method according to claim 36, wherein at least one treatment feature includes one or more selected from the following: the positioning of the target chord to be shortened; the degree of shortening of the target chord; the location on the target chord where the implant is to be placed; the number of chords on which one or more implants are to be placed; the number of implants to be implanted.

38. A method according to any one of claims 31 to 37, wherein an apparatus as defined in any one of claims 1 to 30 is used.

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