Valve leaflet treatment system and method

Abstract

The implant (550) includes a downstream assembly (700) including a patch (610), a patch anchor (640), a winch (720) coupled to a winch anchor (710), and a tether (560) connecting the winch to the patch. The delivery tool (800) includes a shaft (810), a clasp (830), a driver (850), and one or more drive shafts (880, 882) extending through the shaft. The clasp is configured to grasp the leaflets of a valve of a subject's heart. The driver is configured to secure the patch to the leaflets by forcing the patch anchor through the leaflets while a portion of the leaflets is grasped by the clasp. The drive shaft is operably coupled to the downstream assembly to apply a securing force to the winch anchor to secure the winch anchor to ventricular tissue of the heart and to actuate the winch independently of applying the securing force.

Description

Technical Field

[0001] Cross - reference to related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 113,430, filed November 13, 2020, entitled "Valve leaflet treatment systems and methods" by Tennenbaum et al., which is incorporated herein by reference in its entirety for all purposes.

Background Art

[0002] Ischemic heart disease can cause mitral valve regurgitation due to a combination of ischemic dysfunction of the papillary muscle and left ventricular dilation seen in ischemic heart disease, followed by displacement of the papillary muscle and dilation of the mitral annulus.

[0003] Dilation of the mitral annulus prevents the leaflets from fully meeting when the valve is closed. Mitral valve regurgitation of blood from the left ventricle to the left atrium results in an increase in total cardiac output and a decrease in cardiac output, as well as subsequent left ventricular failure secondary to volume overload and pressure overload of the left atrium.

[0004] Chronic or acute left ventricular dilation can increase leaflet tethering and cause displacement of the papillary muscle due to chordal tension and annular dilation.

Summary of the Invention

Problems to be Solved by the Invention

[0005] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims unless the claims explicitly list those features. Also, the features described can be combined in various ways. The various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

Means for Solving the Problems

[0006] In some applications, systems and devices are provided that include leaflet patches (e.g., leaflet dilation patches), chordal tendineae tissue for repair, and / or delivery tools for their implantation. The system / device may also include subvalvular devices and / or components. In some applications, systems / devices are provided that facilitate leaflet dilation.

[0007] In some applications, the systems, apparatus, and methods described herein can be used to provide artificial chordae tendineae and / or leaflet expansion to the left side of the heart. In some applications, the systems, apparatus, and methods described herein can be used to provide artificial chordae tendineae and / or leaflet expansion to the right side of the heart. In some applications, the systems, apparatus, and methods described herein can be used to adjust the length between two portions of the heart wall.

[0008] In some applications, a system is provided for use in a valve located between the atria and ventricles of a person's heart, comprising an implant with a patch (e.g., a leaflet widening patch). In some applications, the patch includes a flexible sheet and a patch anchor.

[0009] The system may also include a downstream assembly that may include a winch coupled to a winch anchor. The system may also include a tether connecting the winch to a patch.

[0010] In some applications, the system further includes a delivery tool having a distal portion that can be transcatheterally advanced into the heart while coupled to an implant. In some applications, the delivery tool includes a shaft that defines the longitudinal axis of the delivery tool. In some applications, the delivery tool may include a clasp which may include an upstream support and a downstream support. In some applications, the clasp is transitionable between an open and a closed position.

[0011] In some applications, the open state is configured such that the upstream and downstream supports are positioned spaced apart from each other, and the clasp is configured to receive a portion of the valve leaflet between the upstream and downstream supports. In some applications, the closed state is a gripping state. In some applications, the clasp is configured to grip a portion of the valve leaflet that is received between the upstream and downstream supports by transitioning from the open state to the gripping state, while the portion of the valve leaflet remains positioned between the upstream and downstream supports.

[0012] In some applications, the system further includes a driver configured to secure a patch to a valve leaflet by pushing a patch anchor through the leaflet while a portion of the leaflet is gripped by a clasp.

[0013] In some applications, the system (e.g., a delivery tool) further includes a drive shaft subassembly that extends through a shaft and is operably coupled to a downstream assembly, the drive shaft subassembly being configured to (1) fix the winch anchor to the ventricular tissue of the heart by applying a fixing force to the winch anchor, and (2) operate the winch independently of the application of the fixing force.

[0014] In some applications, the tether extends from the downstream assembly along the shaft, through the clasp, and into the patch.

[0015] In some applications, the driver is positioned along the shaft, parallel to the shaft.

[0016] In some applications, the clasp is positioned laterally from the shaft in both the open and gripped positions.

[0017] In some applications, the driver is configured to secure the patch to the valve leaflet by pushing the patch anchor through a portion of the leaflet that is gripped by the clasp.

[0018] In some applications, the clasp is transitionable toward an open position, after which the patch is secured to the valve leaflet, and a portion of the valve leaflet is released from the clasp while the patch remains secured there.

[0019] In some applications, the upstream and downstream supports are closer to each other in the gripping state than in the open state.

[0020] In some applications, the drive shaft subassembly includes a reference force tube extending through the shaft and engaging with a downstream assembly, and one or more drive shafts extend to the downstream assembly through the reference force tube, and the drive shaft subassembly is configured to actuate the winch by applying torque to the winch, while the reference force tube provides a reference force to the downstream assembly.

[0021] In some applications, the downstream assembly and delivery tool are configured to allow the delivery tool to smoothly rotate the winch anchor relative to the shaft without activating the winch.

[0022] In some applications, the winch anchor includes a helical tissue engagement element, the fixing force includes torque, and the delivery tool is configured to fix the winch anchor to the ventricular tissue by screwing the helical tissue engagement element into the ventricular tissue by applying that torque to the winch anchor.

[0023] In some applications, the distal portion of the delivery tool is coupled to the implant such that the drive shaft subassembly is configured to screw the helical tissue engagement element into the ventricular tissue by applying torque to the winch anchor without rotating the winch against the ventricular tissue.

[0024] In some applications, the distal portion of the delivery tool is coupled to the implant such that the drive shaft subassembly is configured to screw the helical tissue engagement element into the ventricular tissue by applying torque to the winch anchor without rotating the winch relative to the shaft.

[0025] In some applications, the delivery tool includes a capsule coupled to the distal end of the shaft, and the distal portion of the delivery tool is tubally advanceable into the heart while the downstream assembly is housed within the capsule. In some applications, the capsule and winch are shaped to prevent rotation of the winch relative to the shaft while the drive shaft subassembly screws the helical tissue engagement element into the ventricular tissue.

[0026] In some applications, the capsule defines a track for the winch to engage while being contained by the capsule. In some applications, the capsule and downstream assembly are configured such that the drive shaft subassembly causes the downstream assembly to advance distally from the capsule while sliding linearly along the track to screw the helical tissue engagement element into the ventricular tissue.

[0027] In some applications, the track is a lateral opening within the capsule, and the winch defines an opening through which a tether passes from the winch to the patch. In some applications, the projection of the opening into the lateral opening causes the drive shaft subassembly to be configured such that the downstream assembly advances distally from the capsule while sliding linearly along the lateral opening to screw the helical tissue engagement element into the ventricular tissue.

[0028] In some applications, the capsule includes a housing that houses the winch and defines the lateral opening.

[0029] In some applications, the capsule includes an elastic shroud covering the housing. In some applications, the shroud defines the window of the capsule, covering the distal region of the lateral opening while leaving the proximal region of the lateral opening exposed, allowing the distal portion of the delivery tool to advance transcatheterally into the heart while it is housed within the capsule at the opening with the downstream assembly exposed at the window.

[0030] In some applications, the shroud extends distally from the window and defines a slit aligned with the lateral opening.

[0031] In some applications, the drive shaft subassembly is configured such that the opening protrudes into the lateral opening, causing the opening to slide linearly along the lateral opening, and the downstream assembly advances distally from the capsule, while the winch opening temporarily separates the shroud at the slit, thereby screwing the helical tissue engagement element into the ventricular tissue.

[0032] In some applications, the implant includes an upstream assembly that contains a patch anchor bonded to the patch.

[0033] In some application examples, the upstream assembly further includes the code to which the patch anchor is joined to the patch.

[0034] In some applications, the patch anchor has a sharp tip and is configured to be pushed through the valve leaflet by a driver, with the sharp tip penetrating the leaflet.

[0035] In some applications, the delivery tool further includes a hollow needle, and the patch anchor is configured such that a driver is pushed through the valve leaflet while it is positioned within the hollow needle.

[0036] In some applications, the delivery tool further includes a hollow needle configured to puncture the valve leaflet, and a driver is configured to push a patch anchor out of the hollow needle while the hollow needle extends through the valve leaflet.

[0037] In some applications, the patch anchor includes a toggle that partially defines an eyelet along the toggle, and the cord is attached to the patch anchor at the eyelet.

[0038] In some applications, the toggle is a first toggle, and the patch anchor further includes a second toggle that partially defines an eyelet along the second toggle. In some applications, the cord extends from the patch, through the eyelet of the second toggle, to the eyelet of the first toggle. In some applications, the first and second toggles are shaped so that the tension of the cord aligns the first and second toggles in a cross shape.

[0039] In some applications, the toggle generally has a cylindrical outer surface, and the eyelet generally recesses downward from the cylindrical outer surface.

[0040] In some applications, the eyelet extends across the entire toggle.

[0041] In some applications, the toggle is substantially tubular and has side walls that define the lumen.

[0042] In some applications, the eyelet is a cord eyelet, the toggle defines a lateral eyelet on the side wall, and the cord eyelet protrudes laterally from the lateral eyelet.

[0043] In some applications, the cord eyelet is defined by a wire.

[0044] In some applications, the wire is a spring wire, and it is secured to the toggle by the spring function of the spring wire.

[0045] In some applications, the wire is secured to the toggle by a bead fixed to the end of the wire and positioned within the lumen.

[0046] In some applications, the upstream assembly further includes a spring configured to tension the code.

[0047] In some applications, the spring is a compression spring.

[0048] In some applications, the spring is a cantilever spring.

[0049] In some applications, the spring is virtually flat against the patch.

[0050] In some applications, the spring extends beyond the patch sheet.

[0051] In some applications, the spring extends from a plane defined by the patch.

[0052] In some applications, the spring is configured to allow the driver to smoothly push the patch anchor through the valve leaflet by temporarily deforming in response to the tension applied to the cord when the driver pushes the patch anchor through the valve leaflet away from the patch.

[0053] In some applications, when the spring is temporarily deformed, the patch is bonded to the sheet in such a way that it temporarily contracts linearly.

[0054] In some applications, when the spring is temporarily deformed, it is coupled to the sheet so that the spring slides across the sheet.

[0055] In some applications, the patch has a lip side and a root side. In some applications, the driver is configured to secure the root of the patch to the valve leaflet such that the lip of the patch extends toward the opposing leaflet of the valve. In some applications, the patch includes at least one frame defining a lip brace on the lip of the patch and a root brace on the root side of the patch.

[0056] In some applications, the spring is configured such that its temporary strain substantially corresponds to the temporary compression of the spring between the lip brace and the root brace.

[0057] In some applications, the tether is attached to the lip brace and slidably coupled to the root brace, so that the tension applied to the cord temporarily compresses the spring between the lip brace and the root brace by temporarily pulling the lip brace toward the root brace.

[0058] In some applications, the patch defines a root-to-lip axis between the lips along the midline of the patch, and the spring is configured such that its temporary strain substantially provides a deflection of the spring relative to the root-to-lip axis.

[0059] In some applications, the spring is configured such that its temporary deformation effectively provides a deflection of the spring from the root to the lip axis.

[0060] In some applications, the spring is a first spring, and the upstream assembly further includes a second spring, and the first and second springs are configured such that the temporary strain is substantially due to the tension between the first and second springs.

[0061] In some applications, the cord extends back and forth between the first and second springs.

[0062] In some applications, at least one frame defines a patch anchor support connected to a root brace, and a cord extends from the spring, through the patch anchor support, to the patch anchor.

[0063] In some application examples, the tether is connected to the lip brace.

[0064] In some applications, the spring is attached to the base brace.

[0065] In some applications, the spring is configured such that its transient deformation substantially provides for the transient deformation of the spring relative to the root brace.

[0066] In some applications, the spring extends from the root brace to the lip brace.

[0067] In some applications, the spring extends along the midline of the patch, from the root brace to the lip brace.

[0068] In some application examples, The spring is a first spring that extends along the first lateral edge of the patch from the root brace to the lip brace, At least one frame defines a second spring that extends from the root brace to the lip brace along the second lateral edge of the patch.

[0069] In some applications, the spring does not extend to the lip brace.

[0070] In some applications, the clasp is configured to define a slot, and the driver is configured to secure the patch to the valve leaflet by pushing the patch anchor through the leaflet and the slot.

[0071] In some applications, the slot is defined by the downstream support of the clasp.

[0072] In some applications, the clasp defines a slot guard configured to prevent cardiac tissue from entering the slot.

[0073] In some applications, the patch is connected to a patch anchor via a cord. In some applications, the slot guard is elastic and has a resting position that covers the entrance to the slot, thereby preventing cardiac tissue from entering the slot. In some applications, the slot guard is temporarily deflectable away from the slot by the cord, allowing the cord to exit the slot smoothly.

[0074] In some applications, the patch is connected to the patch anchor via a cord. In some applications, the slot guard prevents cardiac tissue from entering the slot by having a closed position that covers the entrance to the slot, and is reversibly retractable from the entrance to the slot, thereby allowing the cord to exit the slot smoothly.

[0075] In some applications, the delivery tool is configured to further include a capsule at the distal end of the shaft, which houses the downstream assembly.

[0076] In some applications, the capsule includes a shroud formed from an elastic polymer.

[0077] In some applications, the capsule is molded to define a side window within it.

[0078] In some applications, the capsule is molded to define a narrow slit extending between the lateral window and the open distal end of the capsule.

[0079] In some applications, the delivery tool has an extracorporeal proximal portion that includes a clasp controller operably coupled to the clasp, so that the clasp transitions between an open state and a gripping state by manipulating the clasp controller.

[0080] In some applications, the clasp controller is operably coupled to the upstream support of the clasp, and as a result, by operating the clasp controller, the clasp transitions between an open state and a gripped state via the movement of the upstream support relative to the shaft.

[0081] In some applications, the proximal portion further includes a driver controller operably coupled to the driver, thereby inducing the driver to screw a patch anchor into the valve leaflet by operating the driver controller.

[0082] In some applications, within the distal portion of the delivery tool, the shaft has a proximal portion and a distal portion, and the proximal portion of the delivery tool further includes a shaft extension device operably coupled to the shaft, so that by operating the shaft extension device, the distal portion of the shaft is reversibly extended distally from the proximal portion of the shaft.

[0083] In some applications, the clasp is connected to the shaft such that as the distal portion of the shaft extends distally from the proximal portion of the shaft, it deflects the downstream support relative to the shaft.

[0084] In some applications, the delivery tool includes a frame that defines the downstream support. In some applications, a first part of the frame is attached to the proximal part of the shaft and a second part of the frame is attached to the distal part of the shaft, so that the frame folds in such a way that the downstream support is deflected relative to the shaft by extending the distal part of the shaft distally from the proximal part of the shaft.

[0085] In some applications, the clasp is connected to the shaft such that as the distal portion of the shaft extends distally from the proximal portion of the shaft, it deflects both the downstream and upstream supports relative to the shaft.

[0086] In some applications, the clasp is connected to the shaft such that, as the distal portion of the shaft extends distally from the proximal portion of the shaft, it deflects both the downstream and upstream supports relative to the shaft without changing the arrangement between them.

[0087] In some applications, the clasp is attached to the shaft such that, as the distal portion of the shaft extends distally from the proximal portion of the shaft, it deflects both the downstream and upstream supports relative to the shaft while the clasp remains in a gripping position.

[0088] In some applications, the proximal portion further includes an anchor controller, which is configured such that, in at least one state of the delivery tool, the drive shaft subassembly operably connects the anchor controller to the winch anchor, and the operation of the anchor controller applies a fixing force to the winch anchor.

[0089] In some applications, the proximal portion further includes a winch controller, and the drive shaft subassembly is operable-coupled to the winch, so that the winch is operated by the operation of the winch controller.

[0090] In some applications, the drive shaft subassembly includes a winch control drive shaft, through which a winch controller is operably coupled to the winch. In some applications, the drive shaft subassembly includes an anchor control drive shaft routed through the winch control drive shaft, through which an anchor controller is operably coupled to the anchor.

[0091] In some applications, the drive shaft subassembly includes a downstream assembly control drive shaft. In some applications, the drive shaft subassembly has a fixed state in which the anchor controller is operably coupled to the winch anchor via the downstream assembly control drive shaft, and as a result, operation of the anchor controller applies a fixing force to the winch anchor.

[0092] In some applications, the drive shaft subassembly has a hoisted state in which the downstream assembly control drive shaft is operably disconnected from the hoisting anchor so that operation of the anchor controller does not apply a fixing force to the winch anchor, and the rotation of the downstream assembly control drive shaft is operably coupled to the winch so that the winch is activated.

[0093] In some applications, in the fixed state, the downstream assembly control drive shaft is positioned at a first axial position relative to the downstream assembly. In some applications, in the hoisted state, the downstream assembly control drive shaft is positioned at a second, different axial position relative to the downstream assembly. In some applications, the delivery tool is transitionable between the fixed and hoisted states via the axial movement of the downstream assembly control drive shaft relative to the downstream assembly.

[0094] In some applications, the first axial position is distal to the second axial position, and the delivery tool can transition from a fixed state to a wound state via movement in the direction of the downstream assembly control drive shaft proximal to the downstream assembly.

[0095] In some applications, the delivery tool further includes a mount configured to support a patch attached thereon and to carry the patch toward the clasp while the clasp is in a gripping state.

[0096] In some applications, the mount is configured to carry the patch by moving distally toward the clasp toward the clasp toward the upstream support of the clasp, with the patch attached thereto, while the clasp is in a gripping state.

[0097] In some applications, the mount is configured to carry the patch toward the upstream support of the clasp by moving distally and laterally toward the clasp toward the clasp, with the patch attached thereto, while the clasp is in a gripping state.

[0098] In some applications, the mount has a retracted position, and the distal portion of the delivery tool can be advanced transcatheterally into the heart while the mount is in the retracted position and the patch is attached to the mount. In some applications, the mount has a ready position in which the mount is positioned closer to the clasp than in the retracted position. In some applications, the driver is configured to push the patch anchor through the valve leaflet to secure the patch to the valve leaflet while the mount is in the ready position with the patch attached to the mount.

[0099] In some applications, the clasp can transition between open and closed positions while the mount remains in the retracted position.

[0100] In some applications, the delivery tool has an extracorporeal proximal portion that includes a mount controller operably coupled to the mount, allowing the mount to be moved between a retracted position and a ready position by operating the mount controller.

[0101] In some applications, the delivery tool further includes a mount control rod to which the mount controller is operably coupled to the mount.

[0102] In some applications, the proximal portion further includes a driver controller operably coupled to the driver, and by operating the driver controller, the driver is guided to screw a patch anchor into the valve leaflet.

[0103] In some applications, the mount control rod is tubular, and the driver extends from the driver controller through the mount control rod.

[0104] In some applications, the extracorporeal proximal portion of the delivery tool further includes a clasp controller operably coupled to the clasp, so that the clasp transitions between an open state and a gripping state by manipulating the clasp controller.

[0105] In some applications, the delivery tool further includes a clasp control wire, through which the clasp controller is operably coupled to the mount.

[0106] In some applications, the mount controller is configured to move the mount between a retracted position and a ready position by sliding the mount toward the clasp on and along the clasp control wire while the clasp is in a gripping position.

[0107] In some applications, the clasp controller is configured to transition the clasp from a gripped state to an open state by retracting a clasp control wire through the mount while the mount is in a retracted position.

[0108] In some applications, the delivery tool further includes one or more wraps, and the distal portion of the delivery tool can be advanced transcatheterally to the heart while the mount is in a retrace position with the patch held relative to the mount by one or more wraps wrapped around the patch and mount.

[0109] In some applications, the distal portion of the delivery tool can be advanced transcatheterally into the heart while the mount is in a retrace position with the patch held in place by one or more wraps wrapped around the patch, mount, and shaft.

[0110] In some applications, the delivery tool further includes one or more spring-loaded brackets configured to hold the wrap taut.

[0111] In some applications, the delivery tool further includes a rod that works in conjunction with a spring-loaded bracket to tighten the wrap and is retractable to release the wrap.

[0112] In some applications, when retracted, the mount is partially curved in an arc around the shaft.

[0113] In some applications, the mount has a convex outer surface, and the patch is attached to the mount such that the patch curves against the convex outer surface of the mount.

[0114] In some applications, the mount is molded to accommodate the patch anchor while the patch is attached to the mount.

[0115] In some applications, the patch anchor is attached to the patch, and the system is configured such that the patch is secured to the mount by the mounting of the patch anchor.

[0116] In some applications, the patch is secured to the surface of the mount by being connected to a patch anchor via a cord, and the patch anchor being positioned in a groove defined on the surface of the mount, the groove being shaped to allow the patch anchor to slide easily along the groove, while preventing the patch anchor from moving laterally out of the groove.

[0117] In some applications, the driver is configured to secure the patch to the valve leaflet by pushing the patch anchor along the groove, out of the end of the groove, and through the valve leaflet, while the mount is in the ready position and the patch is attached to the mount.

[0118] In some applications, the code extends laterally from the patch anchor, through the groove, and toward the patch.

[0119] In some applications, the shaft is retractable within the distal portion of the delivery tool, and the delivery tool has a delivery configuration in which the shaft is retractable, the clasp faces distally, and the distal portion of the delivery tool can be advanced transcatheterally into the heart.

[0120] In some applications, the downstream support is deflected distally in the delivery state compared to the open state.

[0121] In some applications, in the delivery configuration, the downstream support is positioned adjacent to the shaft and substantially parallel to it.

[0122] In some application examples, the clasp is closed during delivery.

[0123] In some applications, the delivery tool has a shaft that is retractable and expandable, and the clasp faces proximal in the retracted state.

[0124] In some applications, the distal portion of the delivery tool is configured to advance downstream through a valve while in a retracted state.

[0125] In some applications, the clasp is closed when the device is contracted.

[0126] In some applications, in the contracted state, the downstream support is deflected in the proximal direction compared to the open state.

[0127] In some applications, when retracted, the clasp extends further laterally from the shaft than when open.

[0128] In some applications, the proximal portion of the delivery tool further includes a shaft extension device operably coupled to the shaft, thereby reversibly extending the distal portion of the shaft distally from the proximal portion by operating the shaft extension device.

[0129] In some applications, the clasp is connected to the shaft such that, as the distal portion of the shaft extends distally from the proximal portion of the shaft, it deflects the downstream support relative to the shaft.

[0130] In some applications, the flexible sheet comprises a first woven layer containing weft and warp threads, and a second woven layer also containing weft and warp threads, with the first woven layer attached to the second woven layer such that the weft threads of the first woven layer are offset relative to the weft threads of the second woven layer.

[0131] In some applications, the second woven layer is attached to the first woven layer such that the weft threads of the first woven layer are offset by 5 to 30 degrees relative to the weft threads of the second woven layer.

[0132] In some applications, the patch has a lip and a root side, and the driver is configured to fix the root side of the patch to the valve leaflet such that the lip of the patch extends toward the leaflet of the opposing valve, and the patch defines a root-to-lip axis along the midline of the patch from the root side to the lip. In some applications, the wefts of the first weave layer and the wefts of the second weave layer are offset from each other and by 5 to 40 degrees with respect to the root-to-lip axis.

[0133] In some application examples, the patch is essentially trapezoidal.

[0134] In some applications, the patch has a lip and a root end, and the driver is configured to secure the root end of the patch to the valve leaflet, so that the lip of the patch extends toward the opposing leaflet of the valve, and the lip is longer than the root end.

[0135] In some applications, the patch anchor is positioned approximately midway along the base of the patch, and the patch further includes auxiliary anchors at the lateral corners of the patch base. In some applications, each auxiliary anchor has a support area attached to the patch and an arm area that is elastically deflectable away from the support area. In some applications, the arm area is configured to puncture and / or clamp the valve leaflet relative to the support area.

[0136] In some applications, the driver is configured to secure the patch to the valve leaflet by pushing the patch anchor through both the patch and the valve leaflet, while the portion of the leaflet remains gripped by the clasp.

[0137] In some applications, the patch anchor includes a tubular staple having a central tubular portion and two lateral tubular portions, with one of the lateral tubular portions of the central tubular portion located at one end of the central tubular portion.

[0138] In some applications, the driver includes two parallel needles, one of which is positioned inside each of the lateral tubular portions, thereby constraining the lateral tubular portions to be parallel to each other. In some applications, the driver is configured to secure the patch to the valve leaflet by advancing the needle and the lateral tubular portions through both the patch and the valve leaflet while the lateral tubular portions are parallel to each other, and to deploy the tubular staple by retracting the needle from the lateral tubular portions.

[0139] In some applications, a patch anchor includes a frame attached to the patch and an arm flexibly coupled to the frame. In some applications, the driver is configured to advance the arm through the valve leaflet while the arm is constrained in a fixed position, and then release the arm so that the patch is secured to the valve leaflet by the arm moving toward the frame in response to the valve leaflet.

[0140] In some applications, the delivery tool further includes a retrieval thread, which is releasably coupled to the anchor, thereby returning the arm to its fixed position by tensioning the retrieval thread.

[0141] In some applications, the arm is flexibly coupled to the frame such that the axis of rotation of the arm relative to the frame traverses the long axis of the frame.

[0142] In some applications, the arm is flexibly coupled to the frame such that the axis of rotation of the arm relative to the frame is parallel to the long axis of the frame.

[0143] In some applications, the delivery tool further includes a retrieval thread that is releasably attached to the anchor, thereby allowing for smooth removal of the patch anchor from the valve leaflet by tensioning the retrieval thread.

[0144] In some applications, the retrieval thread is releasably attached to the anchor, and as a result, by tensioning the retrieval thread, the orientation of the patch anchor can be changed, allowing for smooth removal of the patch anchor from the valve leaflet.

[0145] In some applications, the retrieval thread is releasably attached to the anchor, and as a result, tensioning the retrieval thread allows the patch anchor to be reshaped, facilitating its removal from the valve leaflet.

[0146] In some applications, the winch anchor includes a helical structure engagement element.

[0147] In some applications, the winch anchor further includes a head, a flange, and a return. In some applications, a helical structure engaging element is screwable through the flange so that the head moves toward the flange. In some applications, the return is articulately coupled to the head so that the return slides on the flange, causing the flange to progressively bias the return radially outward as the head moves toward the flange.

[0148] In some applications, the winch anchor includes a tissue engagement element that includes a return structure with a barb and a lance structure with a lance, and the barb extends radially due to relative axial movement between the return structure and the lance structure.

[0149] In some applications, the tissue engagement element further includes an overtube, within which the return structure and lance structure are axially slidable.

[0150] In some applications, the lance structure is effectively located within the return structure.

[0151] In some applications, the return structure is effectively located within the lance structure.

[0152] In some applications, the winch anchor includes a tissue engagement element comprising multiple lances configured to advance into ventricular tissue and automatically deflect laterally within the ventricular tissue. In some applications, the tissue engagement element comprises multiple sleeves, each configured to advance within the ventricular tissue along a corresponding one of the multiple lances.

[0153] In some applications, the lance is more rigid than the sleeve.

[0154] In some applications, a system and / or device is provided for use with a valve located between the atria and ventricles of a subject's heart, wherein the valve has a first leaflet and a second leaflet. The system / device includes an implant comprising a patch (e.g., a leaflet expansion patch), a patch anchor, and a cord. In some applications, the patch comprises a flexible sheet and a frame supporting the flexible sheet and defining a spring. In some applications, the cord connects to the patch anchor to the patch, thereby positioning the patch to junction with the second leaflet during ventricular systole by fixing the patch anchor to the first leaflet, and the spring is configured to tension the cord.

[0155] In some applications, the implant includes an upstream assembly containing a patch and a patch anchor. In some applications, the implant further includes a downstream assembly containing a winch coupled to a winch anchor configured to secure the downstream assembly to ventricular tissue, and a tether connecting the winch to the patch.

[0156] In some applications, the spring is a compression spring.

[0157] In some applications, the spring is a cantilever spring.

[0158] In some application examples, the spring is virtually flat against the patch.

[0159] In some applications, the spring extends from a plane defined by the patch.

[0160] In some applications, the spring extends beyond the patch sheet.

[0161] In some applications, the patch anchor has a sharp tip and is configured to be pushed through the valve leaflet with the sharp tip penetrating the leaflet.

[0162] In some applications, the patch anchor is configured to be pushed through the valve leaflet while it is positioned within the hollow needle.

[0163] In some applications, the spring is configured to smoothly push the patch anchor through the valve leaflet by temporarily deforming in response to tension applied to the cord, pushing the patch anchor away from the patch and through the valve leaflet.

[0164] In some applications, when the spring is temporarily deformed, the patch is bonded to the sheet in such a way that it temporarily contracts linearly.

[0165] In some applications, when the spring is temporarily deformed, it is coupled to the sheet so that the spring slides across the sheet.

[0166] In some applications, the patch has a lip and a root, and a cord connects the patch anchor to the patch by fixing a patch anchor to the first leaflet, thereby positioning the patch so that the lip of the patch extends toward the second leaflet. In some applications, the frame defines a lip brace on the lip of the patch and a root brace on the root side of the patch.

[0167] In some applications, the spring is configured such that its temporary strain substantially corresponds to the temporary compression of the spring between the lip brace and the root brace.

[0168] In some applications, the patch defines a root-to-lip axis between the lips along the midline of the patch, and the spring is configured such that its temporary strain substantially provides a deflection of the spring relative to the root-to-lip axis.

[0169] In some applications, the spring is configured such that its temporary deformation effectively provides a deflection of the spring from the root to the lip axis.

[0170] In some applications, the spring is a first spring, and the frame further includes a second spring, and the first and second springs are configured such that the transient strain is substantially due to the mutual deflection of the first and second springs.

[0171] In some applications, the cord extends back and forth between the first and second springs.

[0172] In some applications, at least one frame defines a patch anchor support connected to a root brace, and a cord extends from the spring, through the patch anchor support, to the patch anchor.

[0173] In some applications, the spring is attached to the base brace.

[0174] In some applications, the spring is configured such that the temporary strain is substantially due to the temporary deflection of the spring relative to the root brace.

[0175] In some applications, the spring extends from the root brace to the lip brace.

[0176] In some applications, the spring extends along the midline of the patch, from the root brace to the lip brace.

[0177] In some applications, the spring is a first spring extending from the root brace to the lip brace along the first lateral edge of the patch, and at least one frame defines a second spring extending from the root brace to the lip brace along the second lateral edge of the patch.

[0178] In some applications, the spring does not extend to the lip brace.

[0179] In some applications, the patch anchor includes a toggle that defines a substantially intermediate eyelet along the toggle, and the cord is attached to the patch anchor at the eyelet.

[0180] In some applications, the system / device further includes a retrieval thread that is coupled to a patch anchor at the substantial upper end of the toggle and configured to release the patch anchor from the first valve leaflet when the retrieval thread is tensioned.

[0181] In some applications, the toggle is a first toggle, and the patch anchor further includes a second toggle that defines an eyelet partially along the second toggle, and the cord extends from the patch through the eyelet of the second toggle to the eyelet of the first toggle, and the first and second toggles are formed to cross each other by tensioning the cord.

[0182] In some applications, the toggle generally has a cylindrical outer surface, and the eyelet generally recesses downward from the cylindrical outer surface.

[0183] In some applications, the eyelet extends across the entire toggle.

[0184] In some applications, the toggle is substantially tubular and has side walls that define the lumen.

[0185] In some applications, the outer wall defines two adjacent lateral holes, and the eyelet is defined by a portion of the lateral wall positioned between the two lateral holes.

[0186] In some applications, a system is provided for use with a valve located between the atria and ventricles of a subject's heart, comprising an implant and a delivery tool. In some applications, the implant includes a tether, a winch, and a winch anchor coupled to the winch. In some applications, the winch includes a housing and a spool disposed therein. In some applications, the tether extends from the winch, and the spool is operably coupled to the tether, so that the tether becomes tensioned when the winch is activated.

[0187] In some applications, the delivery tool has a distal portion that can be advanced transcatheterally into the heart while coupled to the implant. In some applications, the delivery tool includes a drive shaft subassembly that includes a reference force tube coupled to the housing and drive shaft. In some applications, the drive shaft extends through the reference force tube.

[0188] In some applications, the drive shaft has both a fixed and a hoisted state. In some applications, in the fixed state, the drive shaft is operablely coupled to the winch anchor so that the rotation of the drive shaft applies a fixed force to the winch anchor, and is operablely disconnected from the winch so that the rotation of the drive shaft does not actuate the winch. In some applications, in the hoisted state, the drive shaft is operablely disconnected from the winch anchor so that the rotation of the drive shaft does not apply a fixed force to the winch anchor, and is operablely coupled to the winch so that the rotation of the drive shaft actsuate the winch.

[0189] In some applications, in the stationary position, the drive shaft is positioned in a first axial position relative to the winch. In some applications, in the hoisted position, the drive shaft is positioned in a second, different axial position relative to the winch. In some applications, the delivery tool is transitionable between the stationary and hoisted positions via axial movement of the drive shaft relative to the winch.

[0190] In some applications, the first axial position is distal to the second axial position, and the delivery tool can transition from a fixed state to a hoisted state via movement in the direction of the drive shaft proximal to the winch.

[0191] A method is provided for manufacturing a leaflet-like expanding patch for implantation in the heart of a subject, according to some applications, comprising: connecting the root brace to the lip brace of a temporary frame assembly comprising a root brace, a lip brace, and one or more splints; (i) fixing a flexible sheet such that the root edge of the flexible sheet is fixed to the root brace and (ii) the edge of the flexible sheet is fixed to the lip brace; and then removing the splint from the temporary frame assembly.

[0192] In some applications, the splint is connected to the root brace and lip brace via a flangable connection, and removing the splint from the temporary frame assembly involves disconnecting the flangable connection.

[0193] In some applications, this method further includes attaching a flexible tie between the root brace and the lip brace before removing the splint from the temporary frame assembly.

[0194] In some applications, the flexible sheet is a first flexible sheet, and securing the flexible sheet to the temporary frame assembly includes securing the flexible sheet to a first side of the temporary frame assembly. In some applications, the method further includes sandwiching the temporary frame assembly between the first and second flexible sheets by securing a second flexible sheet to a second side of the temporary frame assembly before removing the splint from the temporary frame assembly. In some applications, removing the splint from the temporary frame assembly includes removing the splint between the first and second flexible sheets.

[0195] In some applications, securing the second flexible sheet to the temporary frame assembly includes securing the second flexible sheet to the temporary frame assembly such that (i) the root side edge of the second flexible sheet is secured to the root brace and the root side edge of the first flexible sheet, and (ii) the lip side edge of the second flexible sheet is secured to the lip brace and the lip side edge of the second flexible sheet.

[0196] In some applications, removing a splint from a temporary frame assembly involves removing the splint from between the lateral edge of the first flexible sheet and the lateral edge of the second flexible sheet.

[0197] In some applications, the method further includes removing the splint from between the lateral edge of the first flexible sheet and the lateral edge of the second flexible sheet, and fixing the lateral edge of the first flexible sheet to the lateral edge of the second flexible sheet.

[0198] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0199] In some applications, a system is provided for use in a valve located between the atria and ventricles of a subject's heart, comprising an implant and a delivery system or delivery tool. In some applications, the delivery system / tool ​​includes a shaft, clasp, rail, mount, and driver in the distal portion of the delivery system / tool.

[0200] In some applications, the shaft defines (or extends along) the longitudinal axis of the delivery tool.

[0201] In some applications, the clasp includes a first support and a second support. In some applications, the clasp has an open state in which the first support and the second support are positioned spaced apart from each other, and the clasp is configured to receive a portion of the valve leaflet between the first support and the second support. In some applications, the clasp has a gripping state, and the clasp is configured to grip the portion of the valve leaflet that is to be received between the first support and the second support by transitioning from the open state to the gripping state while a portion of the valve leaflet is positioned between the first support and the second support.

[0202] In some applications, the rail is coupled to the clasp in such a way that it transitions between an open state and a gripped state by changing the tension within the rail.

[0203] In some applications, the implant is mounted on a mount, and the mount is slidable on and along a rail.

[0204] In some applications, the distal portion of the delivery tool can be advanced transcatheterally into the heart while the implant is mounted.

[0205] In some applications, the delivery tool is configured to grip a portion of the valve leaflet by changing the tension within the rail, thereby transitioning the clasp into a gripping position.

[0206] In some applications, the delivery tool is further configured to slide the mount along and on the rail to the clasp while the portion of the valve leaflet is gripped by the clasp, thereby carrying the implant to the clasp and securing the implant to the valve leaflet while the mount is positioned on the clasp.

[0207] In some applications, the delivery tool is configured to subsequently release a portion of the valve leaflet by reversing the change in tension within the rail.

[0208] In some applications, the rail is coupled to a first support. In some applications, the clasp is configured to move into a gripping position due to deflection of at least the first support away from the shaft, so that the rail extends to the clasp in a direction obliquely away from the shaft. In some applications, the delivery tool is configured to slide the mount along the rail obliquely away from the shaft, so that the mount carries the implant to the clasp in a direction obliquely away from the shaft.

[0209] A method is provided comprising using a leaflet grasping element to grasp the leaflets of an atrioventricular valve in a patient's heart, according to some applications. The leaflet grasping element may include a long helical coil. In some applications, the leaflets are grasped by helically advancing the long helical coil to the edge of the leaflet so that the length of the long helical coil matches the edge of the leaflet.

[0210] In some applications, the method also includes extending at least one longitudinal member downward from the valve leaflet gripping element through the ventricle of the patient's heart. In some applications, the method includes connecting the longitudinal member to the papillary muscle of the heart.

[0211] In some applications, the long helical coils contain nitinol.

[0212] In some applications, positioning a pad at the edge of the valve leaflet and advancing a long helical coil in a spiral manner includes advancing the long helical coil in a spiral manner through the pad and through the tissue at the edge of the valve leaflet.

[0213] In some applications, the method further includes stabilizing the valve leaflets before grasping them.

[0214] In some applications, stabilizing the valve leaflets involves supporting them from the ventricular surface by using a branched structure to press them against the ventricular surface.

[0215] In some applications, stabilizing the valve leaflets involves clamping them from the atrial and ventricular surfaces by positioning a first clamping element on the atrial surface and a second clamping element on the ventricular surface.

[0216] In some applications, positioning the first and second clamping elements involves using hinges to pivot the first and second clamping elements into a predetermined position.

[0217] In some applications, positioning the first and second clamping elements involves sliding them longitudinally toward each other.

[0218] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0219] A method is provided comprising grasping the leaflets of an atrioventricular valve in a patient's heart using a leaflet grasping element, according to some applications. In some applications, the leaflet grasping element includes a first snap element and a second snap element. In some applications, grasping the leaflets is performed by (a) positioning the first snap element on the atrial surface of the leaflet and (b) positioning the second snap element on the ventricular surface of the leaflet, and by snapping the leaflet in this arrangement.

[0220] In some applications, the method further includes extending at least one longitudinal member downward from the valve leaflet gripping element through the ventricle of the patient's heart. In some applications, the method further includes connecting the longitudinal member to the papillary muscle of the heart.

[0221] In some applications, snapping the valve leaflets involves snapping them by trapping a portion of the leaflet between first and second snapping elements.

[0222] In some applications, snapping the valve leaflet involves puncturing the leaflet with a portion of the first snap element and passing a portion of the first snap element through a space defined by the second snap element.

[0223] In some applications, a portion of the first snap element is (a) compressible in response to a force applied to the first and second legs by the wall of the second snap element defining the space, and (b) expandable when the distal portions of the first and second legs emerge from the space. In some applications, passing through a portion of the first snap involves facilitating the compression and expansion of the first and second legs. In some applications, snapping the valve leaflets involves locking the first snap element in place relative to the second snap element in response to the extension of the first and second legs of the first snap element.

[0224] In some applications, a portion of the first snap element includes a return, and the second snap element is shaped to define a wall that defines space. In some applications, the wall is (a) expandable in response to the movement of the return through space, and (b) compressible once the distal end of the return emerges from space. In some applications, passing through a portion of the first snap includes facilitating the expansion and compression of the wall of the second snap element.

[0225] In some applications, snapping the valve leaflets involves locking the first snap element into place relative to the second snap element, in correspondence with compressing the wall of the second snap element relative to the first and second legs of the first snap element.

[0226] In some applications, the method further includes stabilizing the valve leaflets before grasping them.

[0227] In some applications, stabilizing the valve leaflets involves supporting them from the ventricular surface by using a branched structure to press them against the ventricular surface.

[0228] In some applications, leaflet stabilization involves clamping the leaflet from the atrial surface and the ventricular surface of the leaflet by positioning a first clamping element on the atrial surface and a second clamping element on the ventricular surface.

[0229] In some applications, positioning the first and second clamping elements involves using hinges to pivot the first and second clamping elements into a predetermined position.

[0230] In some applications, positioning the first and second clamping elements involves sliding the first clamping element longitudinally toward the second clamping element.

[0231] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0232] In some applications, a system and / or apparatus is provided for repairing the leaflets of a patient's atrioventricular valve, comprising a primary longitudinal member configured at a first end to connect to the ventricle of the patient's heart and to the tissue surrounding two or more secondary longitudinal members. In some applications, each of the two or more secondary longitudinal members has a first end configured to connect to the respective positions of the valve leaflets.

[0233] In some applications, the force distribution member is attached to the second end of the main longitudinal member and to the second end of each of two or more secondary longitudinal members, in which case the force distribution member is positioned between the valve leaflets and the tissue surrounding the ventricles of the heart.

[0234] In some applications, the force distribution member is configured to distribute tension between a primary longitudinal member and two or more secondary longitudinal members.

[0235] In some application examples, the force distribution member includes a planar force distribution member.

[0236] In some applications, the force distribution member includes a symmetrical force distribution member.

[0237] In some applications, the force distribution member is formed to define two or more vertices for joining each of the second ends of two or more secondary longitudinal members, and the two or more vertices are spaced apart such that a distance corresponding to the distance between the first ends of the two or more secondary longitudinal members is maintained at the valve leaflets.

[0238] In some applications, the system / device further includes a clamping device coupled to a main longitudinal member, the clamping device configured to control the tension of the main longitudinal member.

[0239] In some applications, the force-distributing member is molded such that it defines openings at connection points where it is joined (a) to the second end of a primary longitudinal member and (b) to the second end of each of two or more secondary longitudinal members.

[0240] In some applications, the main longitudinal member and two or more secondary longitudinal members pass through their respective openings such that a sliding connection is formed between the force distribution member and (1) the main longitudinal member and (2) the two or more secondary longitudinal members.

[0241] In some applications, the main longitudinal member and two or more secondary longitudinal members are locked in place to the force distribution member using respective locks that can be coupled to the second end of the main longitudinal member and the second end of each of the two or more secondary longitudinal members.

[0242] In some applications, a sliding joint allows for easy distribution of tension between the main longitudinal member and two or more secondary longitudinal members.

[0243] A method is provided for repairing the leaflets of a patient's atrioventricular valve, according to some applications, comprising: connecting the first end of a principal longitudinal member to the tissue surrounding the ventricle of the patient's heart; connecting the first ends of two or more secondary longitudinal members to the respective positions of the valve leaflets; and using force-distributing members to distribute tension between the principal longitudinal member and the two or more secondary longitudinal members.

[0244] In some applications, the force distribution members are coupled to the second end of the main longitudinal member and to the second end of each of two or more secondary longitudinal members, so that they are positioned between the valve leaflets and the tissue surrounding the ventricles of the heart.

[0245] In some applications, connecting the major longitudinal member to the tissue at the first end surrounding the ventricle includes connecting the first end of the major longitudinal member to the papillary muscle.

[0246] In some applications, connecting the first end of the main longitudinal member to the tissue surrounding the valve leaflets surrounding the ventricle includes connecting the first end of the main longitudinal member to the ventricular wall.

[0247] In some application examples, the force distribution member includes a planar force distribution member.

[0248] In some applications, the force distribution member includes a symmetrical force distribution member.

[0249] In some applications, the force distribution member is formed to define two or more vertices for joining each of the second ends of two or more secondary longitudinal members, and the two or more vertices are spaced apart such that a distance corresponding to the distance between the first ends of the two or more secondary longitudinal members is maintained at the valve leaflets.

[0250] In some applications, the method further includes tightening the main longitudinal members and controlling the tension of the main longitudinal members by tightening them.

[0251] In some applications, the force-distributing member is molded such that it defines openings at connection points where it is joined (a) to the second end of a primary longitudinal member and (b) to the second end of each of two or more secondary longitudinal members.

[0252] In some applications, the main longitudinal member and two or more secondary longitudinal members pass through their respective openings such that a sliding connection is formed between the force distribution member and (1) the main longitudinal member and (2) the two or more secondary longitudinal members.

[0253] In some applications, the main longitudinal member and two or more secondary longitudinal members are locked in place to the force distribution member using respective locks that can be coupled to the second end of the main longitudinal member and the second end of each of the two or more secondary longitudinal members.

[0254] In some applications, distributing tension between a primary longitudinal member and two or more secondary longitudinal members includes facilitating the smooth operation of a sliding joint.

[0255] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0256] A method is provided, according to some applications, comprising implanting a tube into the ventricular muscle of a patient's heart, passing a longitudinal member through the tube, fixing the longitudinal member to itself, and thereby facilitating a slidable connection between a first portion of the longitudinal member and the tube, and between the longitudinal member and the first portion of the muscle.

[0257] In some applications, the method also includes fastening a second portion of the longitudinal member to the leaflet of the patient's heart valve.

[0258] In some applications, implanting a tube in the ventricular muscle includes implanting a tube in the papillary muscle.

[0259] In some applications, securing a longitudinal member to itself includes securing the longitudinal member with a lock.

[0260] In some applications, securing a longitudinal member to itself includes securing the longitudinal member by crimping, and the method further includes adjusting the tension of the longitudinal member using crimping.

[0261] In some applications, the method further includes adjusting the tension of the longitudinal members before fixing them in place.

[0262] In some applications, the method further includes adjusting the tension of the longitudinal members after fixing them in place.

[0263] In some applications, tube implantation includes implanting a tube with a free end after the initial implantation.

[0264] In some applications, the method includes transplanting a tube and transplanting a tube with a free end, and further includes joining the free ends of the tubes to form a closed loop.

[0265] In some applications, transplanting a tube involves transplanting a tube that has a free end, the tube having shape memory so that the tube can form a closed loop, and transplanting a tube involves enabling the free end to close so that the tube can form a closed loop.

[0266] In some applications, tube implantation involves delivering the tube in a linear configuration within the overtube, passing the overtube through the muscle, and removing the overtube to leave the tube inside the muscle.

[0267] In some applications, the tube has shape memory, and removing the overtube allows the tube to take on a predetermined shape.

[0268] In some applications, enabling the tube to take on a predetermined shape includes enabling the tube to take on a curved shape.

[0269] In some applications, enabling the tube to take on a predetermined shape includes enabling the tube to form a closed loop.

[0270] In some applications, enabling the tubes to take on a predetermined shape includes enabling the free ends of the tubes to be locked together.

[0271] In some applications, enabling the tube to take on a predetermined shape includes enabling the free end of the tube to deform, and enabling the free end of the tube to deform includes enabling the free end to form an anchor to the outer surface of the muscle.

[0272] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0273] A method is provided, according to some applications, comprising helically suturing the central portion of a longitudinal member to the edge of a single valve leaflet of an atrioventricular valve in a patient's heart.

[0274] In some applications, the method subsequently includes extending the first portion of the longitudinal member into the ventricle of the heart, wherein the first portion is downstream of the central portion of the longitudinal member.

[0275] In some applications, this method involves connecting the first end of a longitudinal member to the tissue surrounding the ventricle.

[0276] In some applications, connecting the first end of a longitudinal member to the tissue surrounding the ventricle includes connecting the first end of a longitudinal member to the papillary muscle.

[0277] In some applications, the method further includes connecting the second end of the longitudinal member to the valve leaflet.

[0278] In some application examples, this method

[0279] Extending the second portion of the longitudinal member into the ventricle of the heart, wherein the second portion is located upstream of the central portion of the longitudinal member,

[0280] The method further includes joining the second end of the longitudinal member to the tissue surrounding the memory ventricle.

[0281] In some applications, connecting the second end of a longitudinal member to the tissue surrounding the ventricle includes connecting the second end of a longitudinal member to the papillary muscle.

[0282] In some applications, the first end of a longitudinal member is joined to a helical tissue anchor. In some applications, helical suturing includes passing the helical tissue anchor helically through the leaflet tissue. In some applications, joining the first end of a longitudinal member to the tissue surrounding the ventricle includes advancing the helical tissue anchor helically into the tissue surrounding the ventricle.

[0283] In some applications, connecting the first end of a longitudinal member to the tissue surrounding the ventricle involves spiraling a helical tissue anchor into the papillary muscle.

[0284] In some applications, the method further includes connecting the second end of the longitudinal member to the valve leaflet.

[0285] In some applications, the method further includes extending a second portion of a longitudinal member into the ventricles of the heart, wherein the second portion is upstream of the central portion of the longitudinal member, and connecting the second end of the longitudinal member to the tissue surrounding the ventricles.

[0286] In some applications, connecting the second end of a longitudinal member to the tissue surrounding the ventricle includes connecting the second end of a longitudinal member to the papillary muscle.

[0287] In some applications, connecting the second end of a longitudinal member to the tissue surrounding the ventricle involves using tissue anchors to secure the second end of the longitudinal member.

[0288] In some applications, securing the second end of a longitudinal member using tissue anchors includes securing the second end of a longitudinal member using helical tissue anchors.

[0289] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0290] A method is provided, according to certain applications, comprising passing at least a portion of a leaflet tissue anchor through the leaflet tissue of an atrioventricular heart valve in a patient's heart, wherein the leaflet tissue anchor is coupled to a longitudinal member. In some applications, the free end of the longitudinal member is positioned outside the patient during passage.

[0291] In some applications, the method includes passing a ventricular tissue anchor through the leaflet tissue anchor, then along the longitudinal member, and toward the tissue surrounding the ventricles of the heart.

[0292] In some applications, this method involves attaching ventricular tissue anchors to the tissue surrounding the ventricles.

[0293] In some applications, the method includes adjusting the tension of a longitudinal member.

[0294] In some applications, passing a leaflet tissue anchor through the leaflet tissue includes piercing the leaflet.

[0295] In some applications, piercing the leaflet includes piercing the leaflet with a portion of the leaflet tissue anchor.

[0296] In some applications, piercing the leaflet includes advancing a needle through the leaflet prior to passing the leaflet tissue anchor through the leaflet tissue.

[0297] The above method can be carried out in a living animal or in a simulation, for example, on a cadaver, a cadaver heart, a simulator (e.g., a simulated part of the body, heart tissue), etc.

[0298] According to some applications, a system and / or device is provided that includes a long tool for facilitating leaflet expansion and chordae repair.

[0299] In some applications, the long tool includes a central tube shaped to define at least one needle slidable within the lumen of a lateral slot and the central tube. In some applications, the long tool includes a lower structural element configured to be positioned on the ventricular side surface of the leaflet of a patient's heart. In some applications, the long tool includes at least one needle stabilization element movable along the longitudinal axis of the central tube, abutting the atrial side surface of the leaflet, and gripping a portion of the leaflet between the at least one needle stabilization element and the lower structural element.

[0300] In some applications, the system / device includes a leaflet expansion patch that can be delivered through a central tube. The leaflet expansion patch may be identical or similar to any of the leaflet expansion patches described herein. In some applications, the leaflet expansion patch includes a flap (e.g., a planar flap, a non-planar flap, a flat flap, a thin flap, a long flap, etc.) configured to emerge from a lateral slot of the central tube. In some applications, the leaflet expansion patch includes at least one tensioning member coupled to the flap.

[0301] In some applications, the leaflet expansion patch includes at least one locking element, which includes a proximal end and a distal end. In some applications, the at least one locking element is coupled to the first end of at least one tension member. In some applications, the at least one locking element is deliverable through one of the needles of at least one long tool to lock the flap in place relative to the leaflet.

[0302] In some applications, at least one locking element includes a "T"-shaped locking element that is compressible within at least one needle and expandable when unfolded from within the needle.

[0303] In some applications, at least one tension member is configured to be attached to the tissue surrounding the ventricles of the heart.

[0304] In some applications, the system / device further includes at least one longitudinal member coupled to at least one tension member, the at least one longitudinal member being coupled at its first end to the at least one tension member, and the second end of the at least one longitudinal member being coupled to the tissue surrounding the ventricles of the heart.

[0305] In some applications, at least one tension member is passed through the flap.

[0306] In some applications, at least one tension member has shape memory, and at least one tension member deforms the flap from a compressed configuration to an expanded configuration.

[0307] In some applications, at least one locking element includes a long rod-shaped (tubular) locking element, and at least one rod-shaped locking element is configured to rotate laterally from the vertical direction in which it is positioned within the at least one needle, so that its longitudinal axis is parallel to the ventricular surface of the valve leaflet, when it is deployed from within the at least one needle and pressed against the ventricular surface of the valve leaflet.

[0308] In some applications, at least one tensioning member includes a cloth or polymer thread.

[0309] In some applications, the leaflet enlargement patch further includes a support frame attached to the flap.

[0310] In some applications, the support frame has shape memory and is configured to deform the flap from a compressed configuration to an expanded configuration.

[0311] In some applications, at least one needle includes an angled tip, which includes a sharp distal tip portion and a blunt proximal tip portion.

[0312] In some applications, the system / device further includes at least one tension member extending through a central tube and releasably coupled to at least one locking element.

[0313] In some applications, at least one locking element includes an eyelet, and at least one tension member is looped through the eyelet of at least one locking element, so that one stand of the tension member extends from one side of the eyelet and another stand of the tension member extends from the other side of the eyelet.

[0314] In some applications, the system / apparatus includes a U-shaped loop, at least one locking element further includes a first and a second locking element, the U-shaped loop is attached to the first and second locking elements at the end of its tail, at least one tension member is looped through the U-shaped loop, such that one strand of the tension member extends from one side of the U-shaped loop and another strand of the tension member extends from the other side of the U-shaped loop.

[0315] In some applications, at least one locking element includes an expandable locking element configured to transition from its free-state elongated configuration to an expanded configuration when the distal end of the locking element approaches the proximal end of the locking element.

[0316] In some applications, the system / apparatus further includes at least one longitudinal member, and at least one tension member is coupled to the distal end of the locking element at its first end and to at least one longitudinal member at its second end.

[0317] In some applications, the system / apparatus further includes a tension member that extends through a central tube and is releasably coupled to a flap at an end of the flap that faces the second end of at least one tension member.

[0318] In some applications, the proximal end of the locking element is tapered radially inward in the proximal direction.

[0319] In some applications, the locking element further includes a constriction attached to the proximal end of the locking element, and the constriction is tapered radially inward in the proximal direction.

[0320] According to some applications, a method is provided that includes positioning a portion of an elongated tool between the leaflets of an atrioventricular valve of a patient's heart to facilitate smooth advancement of leaflet expansion and chordae tendineae repair.

[0321] In some applications, the elongated tool includes a central tube molded to define a lateral slot and at least one needle slidable within the lumen of the central tube. In some applications, the elongated tool includes a lower structural element configured to position itself on the ventricular surface of the valve leaflet of a patient's heart valve. In some applications, the elongated tool includes at least one needle stabilizing element movable along the longitudinal axis of the central tube.

[0322] In some applications, this method includes positioning the substructure elements on the ventricular surface of the valve leaflets.

[0323] In some applications, the method includes moving at least one needle stabilizing element along its longitudinal axis to grasp a valve leaflet between at least one needle stabilizing element and a lower structural element, and moving the element to bring the atrial surface of the valve leaflet into contact with at least one needle stabilizing element.

[0324] In some applications, the method includes delivering a leaflet expansion patch through a central tube. The leaflet expansion patch may be identical or similar to any of the leaflet expansion patches described herein. In some applications, the leaflet expansion patch includes a flap (e.g., a planar flap, a non-planar flap, a flat flap, a thin flap, a long flap, etc.) configured to emerge from a lateral slot of the central tube. In some applications, the leaflet expansion patch includes at least one tension member coupled to the flap. In some applications, the leaflet expansion patch includes at least one locking element coupled to the first end of each of the at least one tension member.

[0325] In some applications, this method involves passing a flap through a lateral slot in the central tube and out of the tube, thereby allowing the flap to deform into an expanded configuration.

[0326] In some applications, the method involves locking a flap to a valve leaflet by delivering at least one locking element through at least one needle of a long tool.

[0327] In some applications, at least one locking element includes a "T" shaped locking element, and delivery of at least one locking element includes delivering the "T" shaped locking element in a compressed state within at least one needle and allowing the "T" shaped locking element to expand by pushing it out of the needle.

[0328] In some applications, at least one tension member has shape memory, and enabling the flap to deform into an extended configuration includes enabling the flap to deform via the shape memory of at least one tension member.

[0329] In some applications, the method further includes extending at least one longitudinal member from the flap into the ventricle of the heart, and connecting at least one longitudinal member to the tissue surrounding the ventricle.

[0330] In some applications, extending at least one longitudinal member includes applying tension to at least one longitudinal member, and enabling the flap to deform into an extended configuration includes enabling the flap to deform by applying tension.

[0331] In some applications, connecting at least one longitudinal member to the tissue surrounding the ventricle includes connecting at least one longitudinal member to the papillary muscle.

[0332] In some applications, attaching at least one longitudinal member to the tissue surrounding the ventricle includes attaching at least one longitudinal member to the ventricular wall.

[0333] In some applications, the method further includes extending at least one tension member from the flap into the ventricle of the heart and attaching at least one tension member to the tissue surrounding the ventricle.

[0334] In some applications, extending at least one tension member includes applying tension to at least one tension member, and enabling the flap to deform into an extended configuration includes enabling the flap to deform by applying tension.

[0335] In some applications, attaching at least one tension member to the tissue surrounding the ventricle includes attaching at least one tension member to the papillary muscle.

[0336] In some applications, attaching at least one tension member to the tissue surrounding the ventricle includes attaching at least one tension member to the ventricular wall.

[0337] In some applications, at least one locking element includes a long, rod-shaped locking element, and delivering at least one locking element includes delivering the rod-shaped locking element vertically within at least one needle and unfolding the rod-shaped locking element from within the needle so that the rod-shaped locking element can be oriented laterally.

[0338] In some applications, the leaflet expansion patch includes a support frame with shape memory, allowing the flap to deform into an expanded configuration, which further includes allowing the flap to deform via the shape memory of the support frame.

[0339] In some applications, the method further includes simultaneously pulling two stands of at least one tension member that are looped through the eyelets of at least one locking element.

[0340] In some applications, the method further includes pulling one strand of at least one tension member looped through an eyelet of at least one locking element, while another strand extending from the opposite side of the eyelet moves toward the eyelet, thereby releasing the at least one tension member from the eyelet.

[0341] In some applications, at least one locking element comprises a first and a second locking element, and the method further comprises simultaneously pulling two stands of a tensioning member looped through a U-shaped loop, the U-shaped loop being coupled to the first and second locking elements.

[0342] In some applications, at least one locking element comprises first and second locking elements, and the method further includes pulling one twisted thread of a tension member looped through a U-shaped loop coupled to the first and second locking elements, while another twisted thread of the tension member extending from the opposite side of the U-shaped loop moves toward the U-shaped loop to release the tension member from the U-shaped loop.

[0343] In some applications, the locking element includes an expandable locking element, and delivery of the at least one locking element includes delivering the expandable locking element in a free state within the at least one needle, and unfolding the expandable locking element from within the needle so that the expandable locking element can be extended when tension is applied to the at least one tension member attached to the distal end of the locking element.

[0344] In some applications, the method further includes allowing at least one expandable locking element to move to a free state by pulling at least one longitudinal member coupled to at least one tension member in a proximal direction until the leaflet expansion patch moves to a folded state.

[0345] In some applications, the method involves simultaneously pulling both the tension member and at least one longitudinal member in the proximal direction.

[0346] In some applications, the method further includes pulling one twisted thread of a tensioning member coupled to a flap, while allowing the other twisted thread of the tensioning member to move toward the flap, thereby releasing the tensioning member from the flap.

[0347] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0348] A method is provided, according to some applications, comprising delivering a long tool between the leaflets of an atrioventricular valve in a patient's heart such that a lateral slot in the long tool is positioned between the leaflets, and positioning the long tool such that a single leaflet is moved within the lateral slot of the long tool.

[0349] In some applications, the method involves passing the two ends of a longitudinal member through at least one lumen of a longitudinal tool within a section of the tool that is positioned inside the ventricle of the heart.

[0350] In some applications, the method involves puncturing the valve leaflet from the ventricular surface of the valve leaflet and passing the two ends of the longitudinal member through the valve leaflet toward the atrium of the heart such that the curved portion of the longitudinal member is positioned toward the ventricular surface of the valve leaflet.

[0351] In some applications, the method involves using a tool to pull the two ends of a longitudinal member from the atrial surface of the valve leaflet and toward the ventricle.

[0352] In some applications, the method involves joining the two ends of a longitudinal member to the tissue surrounding the ventricle.

[0353] In some applications, connecting the two ends of a longitudinal member to the tissue surrounding the ventricle includes connecting the two ends of the longitudinal member to the papillary muscle.

[0354] In some applications, attaching two ends of a longitudinal member to the tissue surrounding the ventricle includes attaching two ends of a longitudinal member to the ventricular wall.

[0355] In some applications, each of the two ends of a longitudinal member is connected to its respective needle, and each needle passes through its respective lumen in the tool.

[0356] In some applications, the tool is shaped to define the respective lumen of each part of the longitudinal member, and passing through the two ends of the longitudinal member includes passing each end of the longitudinal member through the respective lumen of the tool.

[0357] In some applications, each of the two ends of a longitudinal member is connected to a needle, and each needle passes through the respective lumen of the tool.

[0358] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0359] A method is provided, according to some applications, comprising delivering a long docking element delivery tool between the leaflets of the atrioventricular valves of a patient's heart and bonding the docking element to the tissue surrounding the ventricles of the heart. In some applications, the docking element is shaped to define a receptacle.

[0360] In some applications, the method involves delivering a tissue anchor delivery tool to the atrial surface of one of the leaflets of the atrioventricular valve.

[0361] In some applications, this method involves puncturing the tissue of the valve leaflet.

[0362] In some applications, the method includes (a) a tissue anchor coupled to the first end of a longitudinal member, and (b) the first portion of the longitudinal member being passed through the valve leaflet into the ventricle via a tissue anchor delivery tool.

[0363] In some applications, the method involves advancing the tissue anchor further into the receptacle of the docking element to connect the tissue anchor and the first end of the longitudinal member to the docking element.

[0364] In some applications, the method includes locking the second end of a longitudinal member to the valve leaflet.

[0365] In some applications, the tissue anchor includes one or more expandable projections that are compressed during passage through the tissue anchor, and the docking element is formed to define one or more openings.

[0366] In some applications, connecting the tissue anchor and the first end of the longitudinal member to the docking element includes aligning one or more expandable projections of the tissue anchor with one or more openings of the docking element, thereby allowing the one or more projections to expand through the one or more openings and lock the tissue anchor to the docking element.

[0367] In some applications, attaching the docking element to the tissue surrounding the ventricle includes attaching the docking element to the papillary muscle.

[0368] In some applications, attaching the docking element to the tissue surrounding the ventricle includes attaching the docking element to the ventricular wall.

[0369] In some applications, this method further includes adjusting the tension of the longitudinal members.

[0370] In some applications, adjusting the tension involves adjusting the tension to the valve leaflet by locking the second end of the longitudinal member.

[0371] In some applications, adjusting the tension involves engaging the longitudinal member with a tension adjustment tool, pulling the longitudinal member with the tension adjustment tool, and then adjusting the tension by locking the longitudinal member in place to fix the tension applied to the longitudinal member, thereby locking the second end of the longitudinal member with the valve leaflet.

[0372] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0373] A system and / or apparatus is provided comprising at least one curved rigid element having a distally sharp tip configured to puncture cardiac tissue from the atrial surface of the atrioventricular valve of the patient's heart toward the ventricular surface of the atrioventricular valve, and then from the ventricular surface toward the atrial surface of the original valve leaflet of the atrioventricular valve.

[0374] In some applications, the system / device includes an artificial leaflet patch configured to enlarge the natural leaflet, and the artificial leaflet patch is configured to bond to the distal sharp tip of a curved rigid element.

[0375] In some applications, the system / device includes at least one longitudinal member configured to extend from a portion of the artificial valve leaflet patch at its first end and to connect at its second end to the tissue surrounding the ventricle of the heart.

[0376] In some applications, at least one longitudinal member includes multiple longitudinal members.

[0377] In some applications, at least one of the curved rigid elements is made of metal.

[0378] In some applications, at least one curved stiff element includes two curved stiff elements joined together by a bridge.

[0379] In some applications, the distal, sharp tip includes multiple barbs designed to hook onto the artificial valve leaflets.

[0380] In some applications, the distal sharp tip includes multiple barbs, and the artificial valve leaflet patch includes a connecting portion configured to engage with and bond to the multiple barbs.

[0381] In some applications, the distal sharp tip includes multiple barbs, and the artificial valve leaflet patch includes a socket configured to surround the multiple barbs.

[0382] In some applications, the system / device further includes a tissue anchor connected to a second end of a longitudinal member.

[0383] In some applications, the tissue anchor includes a sharp tip configured to penetrate the tissue surrounding the ventricle.

[0384] In some applications, tissue anchors include rings configured to surround the tissue surrounding the ventricles.

[0385] In some applications, the tissue anchor includes a cuff configured to surround the tissue surrounding the ventricle.

[0386] A method is provided, according to some applications, comprising: puncturing cardiac tissue from the atrial surface of a patient's atrioventricular valve with the distal end of at least one curved rigid element; passing the distal sharp tip toward the ventricular surface of the atrioventricular valve; puncturing the ventricular surface of the original valve leaflet of the atrioventricular valve with the distal sharp tip; and passing the distal sharp tip from the ventricular surface of the original valve leaflet toward the atrial surface of the original valve leaflet.

[0387] In some applications, this method involves enlarging the original valve leaflets by attaching an artificial leaflet patch to the distal, sharp tip.

[0388] In some applications, the method includes extending at least one longitudinal member, joined at its first end, into the ventricle of the patient's heart, onto an artificial valve leaflet patch.

[0389] In some applications, the method includes connecting the second end of at least one longitudinal member to the tissue surrounding the ventricle.

[0390] In some applications, puncturing cardiac tissue from the atrial surface includes puncturing the tissue of the atrioventricular valve annulus.

[0391] In some applications, attaching the second end of at least one longitudinal member to the tissue surrounding the ventricle includes attaching the second end of the longitudinal member to the tissue of the ventricular wall.

[0392] In some applications, connecting the second end of a longitudinal member to the tissue surrounding the ventricle includes connecting the second end of a longitudinal member to the papillary muscle tissue.

[0393] In some applications, at least one of the curved rigid elements is made of metal.

[0394] In some applications, at least one curved rigid element comprises two curved rigid elements joined together by a bridge, each of the two curved rigid elements having a distal sharp tip, puncturing cardiac tissue comprises puncturing cardiac tissue with the distal sharp tips of the two curved rigid elements, and attaching an artificial valve leaflet patch comprises attaching an artificial valve leaflet patch to the distal sharp tips of the two curved rigid elements.

[0395] In some applications, attaching the leaflet patch of the prosthesis to the distal sharp tip involves surrounding the leaflet patch of the prosthesis with multiple barbs attached to the distal sharp tip.

[0396] In some applications, attaching the prosthetic leaflet patch to its distal end involves attaching the attachment portion of the prosthetic leaflet patch to a number of barbs attached to the sharp distal end.

[0397] In some applications, extending at least one longitudinal member includes extending multiple longitudinal members into the ventricle, and connecting the second end of each longitudinal member to the tissue surrounding the ventricle includes connecting the second end of each of the multiple longitudinal members to the tissue surrounding the ventricle.

[0398] In some applications, connecting the second end of a longitudinal member to the tissue surrounding the ventricle involves connecting the second end of the longitudinal member using tissue anchors connected to the second end of the longitudinal member.

[0399] In some applications, joining the second end of a longitudinal member involves penetrating the tissue surrounding the ventricle with the sharp tip of a tissue anchor.

[0400] In some applications, joining the second end of a longitudinal member involves surrounding the tissue surrounding the ventricle with tissue anchors.

[0401] In some applications, joining the second end of a longitudinal member involves surrounding the tissue surrounding the ventricle with the cuff of the tissue anchor.

[0402] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0403] In accordance with some applications, a system and / or apparatus is provided comprising a frame formed to define a central ring coupled to a plurality of circumferentially arranged pillars with respect to a central ring, and tissue anchors coupled to the central ring of the frame, wherein the tissue anchors are configured to be coupled to a portion of the patient's cardiac tissue.

[0404] In some applications, the system / device also includes polymer sheets bonded to the frame, configured to increase the contact area between the frame and the portion of cardiac tissue.

[0405] In some applications, the system / device includes a frame that is expandable from within a sheath used to deliver the frame and is collapsible around the tissue anchor in order to reinforce the bond between the tissue anchor and the portion of cardiac tissue.

[0406] In some applications, each of the multiple supports is shaped to define the petal shape.

[0407] In some applications, tissue anchors include helical tissue anchors.

[0408] In some applications, the frame includes a shape-memory material, and the frame is self-destructible due to its shape memory.

[0409] In some applications, the frame is collapsible around the tissue anchor in response to the force applied to the frame within a vector toward the tissue anchor.

[0410] In some applications, the frame is crushable around the tissue anchors in a vector toward the tissue anchors due to the force applied to the frame by the polymer sheet.

[0411] In some applications, the frame is collapsible when tension is applied to the central ring.

[0412] In some applications, the system / device further includes at least one longitudinal element coupled to a central ring at its first end, and the frame is collapsible in response to tension applied to the longitudinal members.

[0413] In some applications, the central ring is shaped to define a loop that extends away from the periphery of the central ring, and the first end of the longitudinal member is joined to the loop.

[0414] In some applications, the system / device further includes a leaflet tissue anchor coupled to a second end of a longitudinal member, the second end of the longitudinal member being configured to bond to the leaflet tissue of the patient's heart via the leaflet tissue anchor.

[0415] A method is provided for delivering a distal end portion of a sheath into the ventricles of a patient's heart, comprising a central ring coupled to a plurality of circumferentially arranged supports relative to the central ring, and a frame molded to define tissue anchors coupled to the central ring of the frame, according to some applications. In some applications, the sheath also contains a polymer sheet coupled to the frame, configured to increase the contact area between the frame and the portion of cardiac tissue. In some applications, the frame and polymer sheet are compressed during delivery.

[0416] In some applications, the method involves exposing the frame, tissue anchors, and polymer sheet from within the sheath so that the frame and polymer sheet expand from a compressed state to an expanded state.

[0417] In some applications, this method involves attaching tissue anchors to a portion of cardiac tissue and thereby facilitating the collapse of the frame and polymer sheet around the portion of cardiac tissue.

[0418] In some applications, each of the multiple supports is shaped to define the petal shape.

[0419] In some applications, attaching tissue anchors to portions of cardiac tissue includes attaching tissue anchors to papillary muscles.

[0420] In some applications, attaching a tissue anchor to a portion of cardiac tissue includes attaching a tissue anchor to a portion of the ventricular wall.

[0421] In some applications, the tissue anchor includes a helical tissue anchor, and attaching the tissue anchor to a portion of cardiac tissue involves pushing the helical tissue anchor into the portion of cardiac tissue.

[0422] In some applications, the frame includes a shape-memory material, and exposing the frame allows the frame to self-expand.

[0423] In some applications, the frame includes a shape-memory material, and facilitating the collapse of the frame involves allowing the frame to self-collapse around portions of the heart tissue.

[0424] In some applications, facilitating frame collapse involves facilitating the exposure of the frame to forces applied to it within a vector toward tissue anchors.

[0425] In some applications, facilitating frame collapse involves facilitating the exposure of the frame to forces applied to it by polymer sheets within a vector toward tissue anchors.

[0426] In some applications, facilitating the collapse of the frame involves applying tension to the central ring.

[0427] In some applications, at least one longitudinal element is connected to a central ring at its first end, and promoting frame collapse involves applying tension to the central ring by applying tension to the longitudinal member.

[0428] In some applications, the central ring is shaped to define a loop that extends away from the periphery of the central ring, and the first end of the longitudinal member is joined to the loop.

[0429] In some applications, the method further includes joining the second end of the longitudinal member to the tissue of the valve leaflet of the patient's heart.

[0430] The above methods can be carried out on living animals or in simulations, for example, on cadavers, cadaveric hearts, or simulators (e.g., a simulated part of the body, heart tissue).

[0431] The present invention will be better understood from the following embodiments for carrying out the invention, along with the drawings. [Brief explanation of the drawing]

[0432] [Figure 1] Figures 1A and 1B are schematic diagrams of examples of valve leaflet gripping elements in some application examples. [Figure 2] Figures 2A and 2B are schematic diagrams of embodiments of valve leaflet gripping elements, each comprising a first snap element and a second snap element, according to some application examples. [Figure 3] Figures 3A to 3C are schematic diagrams of embodiments of valve leaflet gripping elements, each comprising a first snap element and a second snap element, according to some application examples. [Figure 4] Figures 4A to 4C are schematic diagrams of examples of valve leaflet gripping elements, which include hourglass-shaped elements, based on some application examples. [Figure 5] Figures 5A and 5B are schematic diagrams of examples of valve leaflet gripping elements, which include multiple secondary sutures attached to a primary suture, based on some application examples. [Figure 6] Figures 6A to 6C are schematic diagrams of examples of valve leaflet gripping elements comprising multiple secondary sutures attached to a primary suture, based on some application examples. [Figure 7]Figures 7A and 7B are schematic diagrams of examples of valve leaflet gripping elements equipped with clamps, based on some application examples. [Figure 8] Figure 8 is a schematic diagram of an example of a valve leaf gripping element equipped with a force distribution member, based on some application examples. [Figure 9] Figure 9 is a schematic diagram of various examples of ventricular muscle tubes configured to facilitate the smooth sliding connection of longitudinal members, based on some application examples. [Figure 10] Figures 10A to 10E are schematic diagrams of examples of valve leaflet gripping elements equipped with staples, based on some application examples. [Figure 11] Figures 11A and 11B are schematic diagrams illustrating an example of spiral suturing of the edges of the valve leaflets, according to some application examples. [Figure 12] Figures 12A to 12C are schematic diagrams of an example in which the edges of the valve leaflets are sutured in a spiral pattern, according to some application examples. [Figure 13] Figure 13 is a schematic diagram of an embodiment of a valve leaflet gripping element equipped with a stent, based on some application examples. [Figure 14] Figures 14A to 14C are schematic diagrams of various examples of leaflet gripping elements configured to pass through the leaflet tissue, based on some application examples. [Figure 15] Figures 15A and 15B are schematic diagrams of various examples of leaflet gripping elements configured to pass through the leaflet tissue, based on some application examples. [Figure 16] Figures 16A to 16C are schematic diagrams of various examples of leaflet gripping elements configured to pass through the leaflet tissue, based on some application examples. [Figure 17] Figures 17A and 17B are schematic diagrams of various examples of valve leaflet stabilization elements configured to hold and stabilize valve leaflets, based on some application examples. [Figure 18] Figures 18A and 18B are schematic diagrams of various examples of valve leaflet stabilization elements configured to hold and stabilize valve leaflets, based on some application examples. [Figure 19]Figures 19A and 19B are schematic diagrams of various examples of valve leaflet stabilization elements configured to hold and stabilize valve leaflets, based on some application examples. [Figure 20] Figures 20A to 20I are schematic diagrams of examples of valve leaflet enlargement and chordae tendineae repair devices, respectively, based on some application examples. [Figure 21] Figures 21A to 21C are schematic diagrams of examples of valve leaflet enlargement and chordae tendineae repair devices, respectively, based on some application examples. [Figure 22] Figures 22A and 22B are schematic diagrams of examples of valve leaflet enlargement and chordae tendineae repair devices, respectively, based on some application examples. [Figure 23] Figures 23A to 23E are schematic diagrams of examples of valve leaflet enlargement and chordae tendineae repair devices, respectively, based on some application examples. [Figure 24] Figures 24A to 24D are schematic diagrams of examples of valve leaflet enlargement and chordae tendineae repair devices, respectively, based on some application examples. [Figure 25] Figures 25A to 25F are schematic diagrams of examples of valve leaflet enlargement and chordae tendineae repair devices, respectively, based on some application examples. [Figure 26] Figures 26A to 26E are schematic diagrams of examples of artificial chordae tendineae transplantation, based on some application examples. [Figure 27] Figures 27A to 27D are schematic diagrams of examples of artificial chordae tendineae transplantation using docking elements, according to some application examples. [Figure 28] Figures 28A to 28C are schematic diagrams of examples of curved cardiac tissue penetration elements, based on some application examples. [Figure 29] Figures 29A to 29C are schematic diagrams of papillary muscle anchors, based on some application examples. [Figure 30] Figures 30A to 30C are schematic diagrams of examples of valve leaflet gripping elements, which include clamps configured to grip and puncture valve leaflets, according to some application examples. [Figure 31] Figures 31A and 31B are schematic diagrams of systems and techniques for treating the heart of a subject, based on some application examples. [Figure 32] Figures 32A to 32Q are schematic diagrams of systems and techniques for treating the heart of a subject, based on some application examples. [Figure 33] Figures 33A and 33B are schematic diagrams of systems and techniques for treating the heart of a subject, based on some application examples. [Figure 34] Figures 34A to 34C are schematic diagrams of systems and techniques for treating the heart of a subject, based on some application examples. [Figure 35] Figures 35A and 35B are schematic diagrams of upstream assemblies in some application examples. [Figure 36] Figures 36A to 36K are schematic diagrams of various patches based on some application examples. [Figure 37] Figures 37A to 37G are schematic diagrams of various patches based on some application examples. [Figure 38] Figure 38 is a schematic diagram of a sheet for a valve leaflet enlargement patch, based on some application examples. [Figure 39] Figure 39 is a schematic diagram of various patch anchors and the techniques used with them, based on some application examples. [Figure 40] Figure 40 is a schematic diagram of various patch anchors and the techniques used with them, based on some application examples. [Figure 41] Figures 41A and 41B are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 42] Figures 42A to 42D are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 43] Figures 43A to 43C are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 44] Figure 44 is a schematic diagram of various patch anchors and the techniques used with them, based on some application examples. [Figure 45]Figures 45A to 45C are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 46] Figures 46A and 46B are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 47] Figures 47A to 47C are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 48] Figures 48A and 48B are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 49] Figures 49A to 49D are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 50] Figures 50A to 50C are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 51] Figures 51A to 51E are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 52] Figures 52A and 52B are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 53] Figures 53A and 53B are schematic diagrams of various patch anchors and the techniques used with them, based on some application examples. [Figure 54] Figures 54A and 54B are schematic diagrams of various winch anchors and the technologies used with them, based on some application examples. [Figure 55] Figures 55A to 55C are schematic diagrams of various winch anchors and the technologies used with them, based on some application examples. [Figure 56] Figures 56A and 56B are schematic diagrams of various winch anchors and the technologies used with them, based on some application examples. [Figure 57]Figures 57A and 57B are schematic diagrams of various winch anchors and the technologies used with them, based on some application examples. [Figure 58] Figures 58A to 58C are schematic diagrams of various winch anchors and the technologies used with them, based on some application examples. [Figure 59] Figures 59A to 59C are schematic diagrams of various winch anchors and the technologies used with them, based on some application examples. [Figure 60] Figure 60 is a schematic diagram of a downstream assembly in some application examples. [Figure 61] Figures 61A and 61B are schematic diagrams of downstream assemblies in several application examples. [Figure 62] Figures 62A and 62B are schematic diagrams of downstream assemblies in several application examples. [Figure 63] Figure 63 is a schematic diagram of a downstream assembly in several application examples. [Figure 64] Figure 64 is a schematic diagram of a downstream assembly in several application examples. [Figure 65] Figures 65A and 65B are schematic diagrams of downstream assemblies in several application examples. [Figure 66] Figures 66A to 66D are schematic diagrams of clasps in several application examples. [Modes for carrying out the invention]

[0433] Refer here to Figures 1A-1B, schematic diagrams of a system 20 comprising a leaflet gripping element 22, which may comprise a long helical coil 24 according to some applications. The leaflet gripping element 22 is shown as a helical coil 24, not as an example but as an example, and may comprise staples, clips, spring anchors, or other tissue anchors known in the art. The leaflet gripping element 22 is configured to grip the leaflets 10 of the atrioventricular valve of the patient's heart. In some applications, the atrioventricular valve includes a prosthetic valve. In some applications, the atrioventricular valve includes a tricuspid valve.

[0434] The helical coil 24 comprises a flexible material (e.g., a metal such as Nitinol, or a fabric such as braided cloth). In some applications, the tip of the helical coil 24 is provided with a sharp tip configured to puncture the tissue of the valve leaflet 10. The helical coil 24 is helical to the edge 12 of the valve leaflet 10, such that the length L1 of the elongated helical coil 24 is aligned with the edge 12 of the valve leaflet 10, for example, extending along the edge 12 of the valve leaflet 10 or being substantially parallel to the edge 12.

[0435] At least one longitudinal member 28 extends downward from the valve leaflet gripping element 22 through the ventricle of the heart and is coupled to cardiac ventricular tissue such as the papillary muscle 14 or the ventricular wall using any suitable tissue anchor known in the art, such as cotton splices, knots, clips, helical tissue anchors, or barbs. In some applications, the longitudinal member 28 is coupled to a helical coil 24. The longitudinal member 28 may function as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises a suture. In some applications, the longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE). In some applications, the longitudinal member 28 comprises at least one portion comprising at least one wire / suture portion and an elongated tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0436] In some applications, a support pad 26 is coupled to the edge 12 of the valve leaflet 10 before the helical coil 24 advances helically. The coil 24 advances helically relative to the pad 26. The pad 26 is configured to distribute the force of the coil 24 onto the edge 12 of the valve leaflet 10. The pad 26 may be made of fabric, synthetic material, rubber, or a metal such as nitinol.

[0437] In some applications, the system 20 does not include a helical coil 24. Instead, a support pad 26 and a coiled needle are used to deliver the suture in a coil to the edge 12 of the valve leaflet 10. In this method, the suture can be helically sutured to the valve leaflet 10. After the valve leaflet is helically sutured with the suture, the helical needle can be removed from the patient's body. The support pad 26 distributes the force of the helically arranged suture to the edge 12 of the valve leaflet 10. In this way, the support pad 26 prevents tearing of the valve leaflet 10 tissue.

[0438] Hereinafter, we refer to Figures 2A to 2B, schematic diagrams of a system 30 comprising a leaflet gripping element 32 having a first snap element 34 and a second snap element 36, according to some applications. The leaflet gripping element 32 is shown as a snap clasp, not limiting it to examples, and may comprise staples, clips, spring anchors, or other tissue anchors known in the art. The leaflet gripping element 32 is configured to grip the leaflets 10 of the atrioventricular valve of the patient's heart. In some applications, the atrioventricular valve includes a prosthetic valve. In some applications, the atrioventricular valve includes a tricuspid valve.

[0439] The first snap element 34 and the second snap element 36 are made of a biocompatible metal such as nitinol or stainless steel.

[0440] The first snap element 34 is positioned on the atrial surface of the valve leaflet 10, and the second snap element 36 is positioned on the ventricular surface of the valve leaflet 10. The positioning of elements 34 and 36 causes the tissue of the valve leaflet 10 to be grasped or snapped between elements 34 and 36. In some applications, by snapping elements 34 and 36 together, the tissue of the valve leaflet 10 is trapped between the first snap element 34 and the second snap element 36 without, for example, puncturing the tissue of the valve leaflet 10.

[0441] The longitudinal member 28 extends downward from the valve leaflet gripping element 32 through the ventricle of the heart and is coupled to the papillary muscle 14 of the heart using, for example, any suitable tissue anchor known in the art. The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, as shown, the longitudinal member 28 is coupled to a first snap element 34. In some applications, the longitudinal member 28 is coupled to a second snap element 36.

[0442] The first snap element 34 comprises an upper element or upper planar element that provides fixation to the element 34 when the upper element contacts the tissue of the valve leaflet 10. As shown in the figure, the snap element 34 punctures the valve leaflet 10 having a portion of the first snap element 34 having first legs 37 and second legs 37 that are passable through a space 35 defined by the second snap element 36. The second snap element 36 is shown as an example substantially cylindrical element, but is not limited thereto. Each leg 37 is shaped to define a distal portion 38 that is positioned at an angle to the leg 37. The legs 37 are (a) compressible in response to the force applied to the first leg 37 and second leg 37 by the wall of the second snap element 36 defining the space 35, and (b) expandable once the distal portions 38 of the first leg 37 and second leg 37 have emerged from the space 35. Due to the angular arrangement of portion 38 relative to leg portion 37, portion 38 slides within space 35 and when no force is applied to it by the wall of the second snap element 36, and leg portion 37 expands so that the distal portion is larger than space 35, as shown in Figure 2B, to lock the first snap element 34 into place relative to the second snap element 36.

[0443] Herein, according to some applications, we refer to Figures 3A to 3B, schematic diagrams of a system 40 comprising a leaflet gripping element 42 having a first snap element 44 and a second snap element 46. The leaflet gripping element 42 is shown as a snap clasp, not limitingly but exemplifyingly, and may comprise staples, clips, spring anchors, or other tissue anchors known in the art. The leaflet gripping element 42 is configured to grip the leaflets 10 of the atrioventricular valve of the patient's heart. In some applications, the atrioventricular valve includes a prosthetic valve. In some applications, the atrioventricular valve includes a tricuspid valve.

[0444] The first snap element 44 and the second snap element 46 are made of a biocompatible metal such as nitinol or stainless steel.

[0445] The first snap element 44 is positioned on the atrial surface of the valve leaflet 10, and the second snap element 46 is positioned on the ventricular surface of the valve leaflet 10. The positioning of elements 44 and 46 causes the tissue of the valve leaflet 10 to be grasped or snapped between elements 44 and 46. In some applications, by snapping elements 44 and 46 together, the tissue of the valve leaflet 10 is trapped between the first snap element 44 and the second snap element 46 without, for example, puncturing the tissue of the valve leaflet 10.

[0446] The longitudinal member 28 extends downward from the valve leaflet gripping element 42 through the ventricle of the heart and is coupled to the papillary muscle 14 of the heart using, for example, any suitable tissue anchor known in the art. The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 is coupled to a first snap element 44 as shown. In some applications, the longitudinal member 28 is coupled to a second snap element 46.

[0447] The first snap element 44 comprises an upper element or upper planar element that provides fixation to the element 44 when the upper element contacts the tissue of the valve leaflet 10. As shown, the snap element 44 punctures the leaf valve leaflet 10, having a portion of the first snap element 44 with a return that is passable through a space 47 defined by the second snap element 46. The second snap element 46 is shown, without limitation, as a substantially disc-shaped element having an internal structure with a wall formed as a spiral or coil. As the return of the snap element 44 passes through the space 47, the wall of the second snap element 46 expands to accommodate the width of the return while the return is moving relative to the second snap element 46. Once the return of the first snap element 44 has passed through the second snap element and the return has emerged from the space 47, the wall of the second snap element 46 presses to fix the first snap element in place relative to the second snap element.

[0448] Refer to Figures 4A to 4C, schematic diagrams of a system 50 comprising a valve leaflet gripping element 52 having an hourglass-shaped element made of a blade-like flexible material (e.g., metal such as Nitinol, or fabric such as braided cloth). In the stationary state of element 52, the element is shaped as shown in Figure 4C, that is, element 52 is shaped to define an upper disk 54 and a lower disk 56. When no force is applied to element 52, the element has the shape shown in Figure 4C. When the element is pulled linearly by the braided material of element 52 and constrained within the needle 58, element 52 becomes thinner and longer than in its stationary state. In some applications, the valve leaflet gripping element 52 self-expands to the configuration shown in Figure 4C.

[0449] As shown in Figure 4A, element 52 is deployable from within the needle 58 after the sharp end of the needle 58 has punctured the valve leaflet 10. The valve leaflet 10 can be punctured from the ventricular surface by delivering the needle 58 from within the ventricle and the punctured valve leaflet 10 so that the upper disc 54 is deployed, expanded, and positioned against the atrial surface of the valve leaflet 10 as shown. Once the upper disc 54 is positioned, the needle 58 retracts and is slightly pulled on the disc 54, as a result, it remains in place. Next, the needle 58 retracts further to expose the lower disc 56, as a result, the lower disc 56 is deployed, expanded, and positioned against the ventricular surface of the valve leaflet 10. Note that the needle 58 can also be approached from within the atrium. In this way, the lower disc 56 is delivered first to the ventricular surface of the valve leaflet 10 by analogy.

[0450] A crimp can be attached to the lower disc 56 to lock the final shape of element 52 in place. Alternatively, or additionally, element 52 can be held in place by a chock.

[0451] The positioning of discs 54 and 56 causes the tissue of the valve leaflet 10 to be grasped between discs 54 and 56.

[0452] The longitudinal member 28 extends downward from the valve leaflet gripping element 52 through the ventricle of the heart and is coupled to the papillary muscle 14 of the heart using, for example, any suitable tissue anchor known in the art. The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, as illustrated, the longitudinal member 28 is coupled to the lower disk 56.

[0453] Herein, we refer to Figures 5A to 5B, schematic diagrams of a system 60 comprising a valve leaflet gripping element 62 having a plurality of longitudinal members 64 distributed along the edge 12 of the valve leaflet, according to some applications. In some applications, each of the plurality of longitudinal members 64 is sutured to the tissue of the valve leaflet 10. Each of the plurality of longitudinal members 64 is joined at a first end to a portion of the tissue of the valve leaflet 10 using a suture knot or a respective locking element 66, such as a bead or crimp. The second ends of each of the plurality of longitudinal members 64 are joined together using a connector 68, such as a bead that connects the plurality of longitudinal members 64 to a longitudinal member 28. Thus, the longitudinal member 28 defines the primary longitudinal member, while the plurality of longitudinal members 64 define secondary longitudinal members 64.

[0454] Each of the multiple longitudinal members 64 is coupled to the respective portion of the valve leaflet 10 such that the multiple longitudinal members 64 of the valve leaflet gripping element 62 spread out in a fan shape and the force is distributed along the edge 12 of the valve leaflet 10.

[0455] Refer to Figures 1A-1B and 5A-5B here. Note that the valve leaflet gripping element 62 can be used in combination with the support pads 26 shown in Figures 1A-1B to distribute the force of multiple longitudinal members 64 on the edge 12 of the valve leaflet 10. The pads 26 may be made of fabric, synthetic material, rubber, or metal such as nitinol.

[0456] At least one longitudinal member 28 extends from a lower valve leaflet gripping element 62 through the ventricle of the heart and is coupled to the papillary muscle 14 of the heart using, for example, any suitable tissue anchor known in the art. The longitudinal member 28 functions as an artificial chordae tendineae. The longitudinal member 28 and the secondary longitudinal member 64 are made of a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 and the secondary longitudinal member 64 are coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 and the secondary longitudinal member 64 are made of sutures. In some applications, the longitudinal member 28 is made of at least one portion comprising at least one wire / suture portion and an elongated tension-applying coil. For example, the longitudinal member 28 may have an elongated coil between two wire / suture portions.

[0457] Refer here to Figures 6A to 6C, schematic diagrams of a system 70 comprising a leaflet gripping element 72 having multiple longitudinal members 64 distributed along the edge 12 of the valve leaflet 10, according to some applications. As shown, the element 72 comprises two longitudinal members 64. Note that any suitable number of longitudinal members 64 can be used. The leaflet gripping element 72 comprises a first snap element 74 and a second snap element 76. In some applications, as shown, the first snap element 74 and the second snap element 76 each comprise a plate. In some applications, the plate includes a metal plate, and in some applications, the metal plate is covered with cloth. The leaflet gripping element 72 is shown as a snap fastener, not limitingly but exemplifyingly, and may comprise staples, clips, spring anchors, or other tissue anchors known in the art. The leaflet gripping element 72 is configured to grip the leaflets 10 of the atrioventricular valve of a patient's heart. In some applications, the atrioventricular valve includes a prosthetic valve. In some application examples, the atrioventricular valves include the tricuspid valve.

[0458] The first snap element 74 is positioned on the atrial surface of the valve leaflet 10, and the second snap element 76 is positioned on the ventricular surface of the valve leaflet 10. The positioning of elements 74 and 76 allows the tissue of the valve leaflet 10 to be grasped or snapped between elements 74 and 76. In some applications, by snapping elements 74 and 76 together, the tissue of the valve leaflet 10 is trapped between the first snap element 74 and the second snap element 76 without, for example, puncturing the tissue of the valve leaflet 10.

[0459] The first snap element 74 and the second snap element 76 are made of a biocompatible metal such as nitinol or stainless steel.

[0460] The first snap element 74 comprises an upper element or upper planar element that provides fixation to the element 74 when the upper element or upper planar element contacts the tissue of the valve leaflet 10. As shown in the figure, the second snap element 76 punctures the valve leaflet 10 with each projection 77 of the second snap element 76. The projections 77 are passable through the respective spaces 75 defined by the first snap element 74. As shown in Figure 6B, when the projections 77 of the second snap element 76 engage with the space 75 of the first snap element 74, the first snap element 74 locks into place relative to the second snap element 76.

[0461] It should be noted that the first snap element 74 may have a projection 77, and the second snap element 76 can be shaped to define a space 75.

[0462] It should be noted that in some applications, the projection 77 does not puncture the tissue of the valve leaflet 10, but rather punctures the projection 77 trapping tissue of the valve leaflet 10 between the first snap element 74 and the second snap element 76.

[0463] Each of the multiple longitudinal members 64 is connected at a first end to a second snap element 76. The second ends of each of the multiple longitudinal members 64 are then joined together using a connector 68, for example, a bead that connects the multiple longitudinal members 64 to a longitudinal member 28. In this way, the longitudinal member 28 defines the main longitudinal member, while the multiple longitudinal members 64 define the secondary longitudinal members 64.

[0464] Each of the multiple longitudinal members 64 is coupled to the respective portion of the valve leaflet 10 such that the multiple longitudinal members 64 of the valve leaflet gripping element 62 spread out in a fan shape and the force is distributed along the edge 12 of the valve leaflet 10.

[0465] At least one longitudinal member 28 extends from a lower valve leaflet gripping element 62 through the ventricle of the heart and is coupled to the papillary muscle 14 of the heart using, for example, any suitable tissue anchor known in the art. The longitudinal member 28 functions as an artificial chordae tendineae. The longitudinal member 28 and the secondary longitudinal member 64 are made of a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 and the secondary longitudinal member 64 are coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 and the secondary longitudinal member 64 are made of sutures. In some applications, the longitudinal member 28 is made of at least one portion comprising at least one wire / suture portion and an elongated tension-applying coil. For example, the longitudinal member 28 may have an elongated coil between two wire / suture portions.

[0466] Herein, we refer to Figures 7A to 7B, schematic diagrams of a system 80 comprising a leaflet gripping element 82 having multiple longitudinal members 64 distributed along the edge 12 of the leaflet, according to some applications. As shown, the element 82 comprises three longitudinal members 64. Note that any appropriate number of longitudinal members 64 can be used. The leaflet gripping element 82 comprises a clamp 81 comprising an upper jaw 84 and a lower jaw 86. The leaflet gripping element 82 is shown as a clamp, but not limited to examples, and may comprise staples, clips, spring anchors, or other tissue anchors known in the art. The leaflet gripping element 82 is configured to grip the leaflets 10 of the atrioventricular valve of a patient's heart. In some applications, the atrioventricular valve includes a prosthetic valve. In some applications, the atrioventricular valve includes a tricuspid valve.

[0467] Each of the maxilla 84 and mandible 86 is provided with a plurality of teeth 85 configured to grasp the tissue of the valve leaflet 10 with or without puncturing the tissue of the valve leaflet 10. The teeth 85 increase friction between the clamp 81 and the tissue of the valve leaflet 10.

[0468] The upper jaw 84 of the clamp 81 is positioned on the atrial surface of the valve leaflet 10, and the lower jaw 86 is positioned on the ventricular surface of the valve leaflet 10. The positioning of the jaws 84 and 86 causes the tissue of the valve leaflet 10 to be grasped or snapped between the jaws 84 and 86. In some applications, by closing the jaws 84 and 86 together, a portion of the tissue of the valve leaflet 10 is trapped between the first jaw 84 and the second jaw 86, for example, without puncturing the valve leaflet 10.

[0469] The clamp 81 is made of a biocompatible metal such as nitinol or stainless steel.

[0470] The maxilla 84 includes broad elements or broad planar elements that provide fixation to the maxilla 84 when the broad elements or broad planar elements abut against the tissue of the valve leaflet 10. The mandible 86 includes broad elements or broad planar elements that provide fixation to the mandible 86 when the broad elements or broad planar elements abut against the tissue of the valve leaflet 10. Because the clamp 81 is wide, the force from the longitudinal members 64 and 28 is distributed along the edge 12 of the valve leaflet 10. When the maxilla 84 and 86 close and the teeth 85 of the valve leaflet 10 grip the tissue, the clamp 81 locks into place relative to the valve leaflet 10.

[0471] In some applications, it should be noted that tooth 85 does not puncture the tissue of the valve leaflet 10, but rather tooth 85 traps the tissue of the valve leaflet 10 between the maxillary 84 and the mandibular 86.

[0472] Each of the multiple longitudinal members 64 is joined at its first end in the mandible 86. The second ends of each of the multiple longitudinal members 64 are joined together using a connector 68, for example, a bead that connects the multiple longitudinal members 64 to the longitudinal member 28. In this way, the longitudinal member 28 defines the main longitudinal member, while the multiple longitudinal members 64 define the secondary longitudinal members 64.

[0473] Each of the multiple longitudinal members 64 is coupled to the respective portion of the valve leaflet 10 such that the multiple longitudinal members 64 of the valve leaflet gripping element 62 spread out in a fan shape and the force is distributed along the edge 12 of the valve leaflet 10.

[0474] At least one longitudinal member 28 extends from a lower valve leaflet gripping element 62 through the ventricle of the heart and is coupled to the papillary muscle 14 of the heart using, for example, any suitable tissue anchor known in the art. The longitudinal member 28 functions as an artificial chordae tendineae. The longitudinal member 28 and the secondary longitudinal member 64 are made of a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 and the secondary longitudinal member 64 are coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 and the secondary longitudinal member 64 are made of sutures. In some applications, the longitudinal member 28 is made of at least one portion comprising at least one wire / suture portion and an elongated tension-applying coil. For example, the longitudinal member 28 may have an elongated coil between two wire / suture portions.

[0475] Herein, we refer to Figure 8, a schematic diagram of a system 90 comprising a valve leaflet gripping element 92, which includes a plurality of longitudinal members 64 distributed along the edge 12 of the valve leaflet and a force distribution member 96, according to some applications. As shown, the element 92 comprises three longitudinal members 64. Note that any suitable number of longitudinal members 64, for example, two or more members 64, can be used. The force distribution member 96 is made of a biocompatible metal such as nitinol or stainless steel. In some applications, the force distribution member 96 is made of plastic or rubber.

[0476] A longitudinal member 28 defines the primary longitudinal member, while a plurality of longitudinal members 64 define secondary longitudinal members 64. Each of the plurality of longitudinal members 64 is coupled at a first end to the valve leaflet 10 using, for example, a locking element 66, such as beads, cotton thread, or crimp, which connects the plurality of longitudinal members 64 to the valve leaflet 10. The second end of each of the plurality of longitudinal members 64 is coupled to the force distribution member 96 using, for example, their respective locking elements 93, such as beads, cotton thread, or crimp. The first end of the longitudinal member 28 is coupled to the tissue surrounding the ventricle, such as the papillary muscle 14, using, for example, any suitable tissue anchor known in the art, as shown in the figure. In some applications, the second end of the longitudinal member 28 is coupled to the tissue of the ventricular wall, using, for example, any suitable tissue anchor known in the art. The second end of the longitudinal member 28 is coupled to the force distribution member 96. The force distribution member 96 is positioned within the ventricle between the valve leaflet 10 and the tissue surrounding the ventricle of the heart. The force distribution member 96 is configured to distribute tension between the main longitudinal member 28 and the secondary longitudinal member 64.

[0477] In some applications, the force distribution member 96 comprises a force distribution member (e.g., a planar force distribution member). In some applications, the force distribution member 96 is symmetrical. In some applications, the force distribution member 96 is shaped to define two or more vertices 95 for joining each of the second ends of the secondary longitudinal members 64. The two or more vertices 95 are spaced apart such that a corresponding distance is maintained between the first ends of the secondary longitudinal members 64 at the valve leaflets 10. As shown, the force distribution member 96 is formed as a triangle having three vertices 95.

[0478] The force distribution member 96 is shaped to define an opening 91 at a coupling site (e.g., the center of the force distribution member 96) that is coupled to the second end of the main longitudinal member 28. A locking element 97, such as a bead or cotton thread, is used to lock the longitudinal member 28 to the force distribution member 96. In some applications, the system 90 includes a clamping device, crimp, or latch coupled to the longitudinal member 28, for example, on the longitudinal member 28 or instead of a locking element 97. The tension of the longitudinal member 28 is controlled by the clamping device, crimp, or latch so that the longitudinal member 28 functions as an artificial chordae tendineae. The force distribution member 96 is shaped to define an opening 99 at a coupling site (e.g., vertex 95) that is coupled to the second end of each of the secondary longitudinal members 64.

[0479] The primary longitudinal member 28 and the secondary longitudinal member 64 pass through their respective openings 91 and 99 such that a slidable connection is formed between the force distribution member 96 and (i) the primary longitudinal member 28 and (ii) the secondary longitudinal member 64. The slidable connection facilitates the distribution of tension between the primary longitudinal member 28 and the secondary longitudinal member 64, and as a result, the force is also distributed along the valve leaflet 10. The slidable connection allows the force distribution member 96 to compensate for the different tensions of each of the longitudinal members 64. That is, the force distribution member 96 compensates for slack in one of the members 64 while the second member 64 may be more taut. In this way, the force distribution member 96 enhances the durability of the longitudinal members 28 and 64 over time because the force is evenly distributed over the longitudinal members 28 and 64, and as a result, no one longitudinal member 28 or 64 is subjected to greater tension than the other.

[0480] Here, refer to the details in Figures 1A-1B and Figure 8. Note that the valve leaflet locking element 66 can be used in combination with the support pad 26 shown in Figures 1A-1B to distribute the forces of multiple longitudinal members 64 to the edges 12 of the valve leaflet 10. The pad 26 may be made of fabric, synthetic material, rubber, or metal such as nitinol.

[0481] Each of the multiple longitudinal members 64 is coupled to the respective portion of the valve leaflet 10 such that the multiple longitudinal members 64 of the valve leaflet gripping element 92 spread out in a fan shape and the force is distributed along the edge 12 of the valve leaflet 10.

[0482] The locking element 66 is shown as a bead, not as an example, and may comprise a staple, clip, spring anchor, or other tissue anchor known in the art. The leaflet gripping element 92 is configured to grip the leaflets 10 of the atrioventricular valve of the patient's heart. In some applications, the atrioventricular valve includes a prosthetic valve. In some applications, the atrioventricular valve includes a tricuspid valve.

[0483] The multiple secondary longitudinal members 64, together with the force distribution member 96, collectively define a positional distribution element 94 that can distribute the multiple secondary longitudinal members 64 at their respective positions along the edge 12 of the valve leaflet 10 so that the tension on the valve leaflet 10 is distributed.

[0484] The longitudinal members 64 and 28 extend downward from the valve leaflet 10 through the ventricle. The longitudinal member 28 functions as an artificial chordae tendineae. The longitudinal member 28 and the secondary longitudinal member 64 are made of a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 and the secondary longitudinal member 64 are coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 and the secondary longitudinal member 64 are made of sutures. In some applications, the longitudinal member 28 is made of at least one portion comprising at least one wire / suture portion and an elongated tension-applying coil. For example, the longitudinal member 28 may have an elongated coil between two wire / suture portions.

[0485] Refer here to Figure 9, a schematic diagram of a system 100 in which each tube is implanted in the ventricular muscle of a patient's heart, for example, the papillary muscle 14, according to some applications, and the tube facilitates a slidable connection between a first portion of a longitudinal member 28 and the tube, and between the first portion of the longitudinal member 28 and the papillary muscle 14. The second end of the longitudinal member 28 (not shown) is coupled to the valve leaflet 10, for example, using any coupling described herein. The tension of the longitudinal member 28 can be adjusted in the direction between the valve leaflet 10 and the papillary muscle 14.

[0486] As shown in the figure, the longitudinal member 28 is fixed to itself using a lock 104 that facilitates a smooth sliding connection between the longitudinal member 28 and the tube, while preventing the longitudinal member 28 from disengaging from the tube. In some applications, the lock 104 comprises a bead. In some applications, the lock 104 comprises a stopper or crimp that allows for easy adjustment of the tension of the longitudinal member 28. In some applications, the tension of the longitudinal member 28 is adjusted before the longitudinal member 28 is fixed. In some applications, the tension of the longitudinal member 28 is adjusted after the longitudinal member 28 is fixed, for example, at a later stage than the initial implantation.

[0487] An overtube (not shown) is used to deliver the tube to the muscle 14 in a linear configuration. The overtube passes through the muscle 14, delivering the tube in a linear configuration. Once the tube is implanted in the muscle 14, the overtube is removed, leaving the tube in the muscle. Upon detachment from the overtube, the tube forms its final shape, as shown in Figure 9. The overtube approaches the papillary muscle 14 from the side, i.e., from above, and in this way the implantation of the tube within the muscle 14 does not interfere with the innate chordae tendineae. Furthermore, by implanting from the side and not using a helical anchor at the top of the muscle 14, the torque on the muscle 14 is reduced and eliminated. Furthermore, the slidable connection between the longitudinal member 28 and the tube provides flexibility to the system 100, allowing for (i) initial adjustment of the tension of the longitudinal member 28, (ii) subsequent adjustment of the tension of the longitudinal member 28, and (iii) reduction of stress on the tissue of the muscle 14 during the tensile force of the longitudinal member 28 on the muscle 14 in a vector defined between the muscle 14 and the valve leaflet 10. That is, the angle of the implantation is different from the vector of the tensile force of the longitudinal member 28 on the muscle 14.

[0488] When the longitudinal member 28 is connected to the valve leaflet 10, the tension in the longitudinal member 28 is adjusted in the direction between the valve leaflet 10 and the papillary muscle 14. That is, the implantation angle of the tube is a non-zero angle, e.g., perpendicular, to the direction of the tension applied to the longitudinal member 28. Furthermore, once the longitudinal member 28 is fixed to the muscle 14 via the tube implanted therein, the longitudinal member 28 is slidably connected to the muscle 14 via the tube, so that forces can be applied to the longitudinal member 28 and the muscle 14 from any direction.

[0489] In some applications, the tube is formed into a predetermined final shape as illustrated in the various embodiments of Figure 9. In some applications, the tube includes a shape memory material, such as nitinol, which allows the tube to take on a predetermined final shape, as shown in the various embodiments of Figure 9. That is, once the overtube is removed, the tube can take on a predetermined shape.

[0490] As shown in the figure, the longitudinal member 28 is looped around the papillary muscle 14 by passing through the tube. In this way, a loop is created in the first part of the longitudinal member 28. The loop of the longitudinal member 28 reduces the tension of the longitudinal member 28 on the tissue of the papillary muscle 14.

[0491] In some applications, the tube comprises a partial ring tube 102 having free ends 103 and 105 and shaped to define a lumen. During implantation, the tube 102 is implanted into the tissue of muscle 14. The tube 102 is delivered in a linear configuration and, once detached from the overtube used to deliver the tube 102, the tube 102 bends into a predetermined curved shape. When the free ends 103 and 105 are exposed from within the muscle 14, the free ends deform so that anchors, such as wings 106 and 108, contact the outer surface of the muscle 14.

[0492] In some applications, the tube comprises a tube 112 having ends 114 and 116 that close to form a closed loop. In some applications, ends 114 and 116 are manually closed by distribution. In some applications, the tube 112 has shape memory that allows ends 114 and 116 to close to form a closed loop in the tube 112. During implantation, the tube 112 is implanted into the tissue of muscle 14. The tube 112 is delivered in a linear configuration and, once removed from the overtube used to deliver the tube 112, the tube 112 bends into a predetermined curved shape. When ends 114 and 116 are exposed from within the muscle 14, ends 114 and 116 deform so that these ends 114 and 116 embrace each other, and the tube 112 self-locks. The ends 114 and 116 form an embrace lock. In some applications, a longitudinal member 28 slides within the lumen of the tube 112. In some applications, the longitudinal member 28 is wound in a loop around a portion of the tube 112.

[0493] In some applications, the tube comprises a tube 120 having ends 122 and 124 that close to form a closed loop. In some applications, ends 122 and 124 are manually closed by the surgeon. In some applications, the tube 120 has shape memory that allows ends 122 and 124 to close to form a closed loop in the tube 120. During implantation, the tube 120 is implanted within the tissue of the muscle 14. The tube 120 is delivered in a straight configuration and, once detached from the overtube used to deliver the tube 120, the tube 120 bends into a predetermined curved shape. When ends 122 and 124 are exposed from within the muscle 14, ends 122 and 124 deform so that they embrace each other, and the tube 120 self-locks. The ends 122 and 124 form an overlap lock, and the ends 122 and 124 are positioned adjacent to each other like a keyring. In some applications, the longitudinal member 28 slides within the lumen of the tube 120. In some applications, the longitudinal member 28 is wrapped in a loop around a portion of the tube 120.

[0494] In some applications, the tube comprises a tube 130 having ends 132 and 134 that close to form a closed loop. In some applications, ends 132 and 134 are closed manually by the surgeon. In some applications, the tube 130 has shape memory that allows ends 132 and 134 to close to form a closed loop of the tube 130. During implantation, the tube 130 is implanted into the tissue of muscle 14. The tube 130 is delivered in a straight configuration and, once detached from the overtube used to deliver the tube 130, the tube 130 bends into a predetermined curved shape. When ends 132 and 134 are exposed from within the muscle 14, ends 132 and 134 deform so that these ends 132 interlock with each other and lock the tube 130. The ends 132 and 134 form a pushable lock and are arranged adjacent to each other like a carabiner or shackle. In some applications, the longitudinal member 28 slides within the lumen of the tube 130. In some applications, the longitudinal member 28 is wrapped in a loop around a portion of the tube 130.

[0495] In some applications, the tube comprises a tube 140 having ends 142 and 144 that close to form a closed loop. In some applications, ends 142 and 144 are manually closed by the surgeon. In some applications, the tube 140 has shape memory that allows ends 142 and 144 to close to form a closed loop in the tube 140. During implantation, the tube 140 is implanted into the tissue of the muscle 14. The tube 140 is delivered in a straight configuration and, once removed from the overtube used to deliver the tube 140, the tube 140 bends into a predetermined curved shape. When ends 142 and 144 are exposed from within the muscle 14, ends 142 and 144 deform so that these ends 142 interlock with each other, and the tube 140 self-locks. End 142 has a post 146 that interlocks into a ring 148 of end 144. In some applications, a longitudinal member 28 slides within the lumen of the tube 140. In some applications, the longitudinal member 28 is wrapped in a loop around a portion of the tube 140.

[0496] In some applications, the tube comprises a tube 150 having ends 152 and 154 that close to form a closed loop. In some applications, ends 152 and 154 are closed manually by the surgeon. In some applications, the tube 150 has shape memory that allows ends 152 and 154 to close to form a closed loop of the tube 150. During implantation, the tube 150 is implanted into the tissue of muscle 14. The tube 150 is delivered in a straight configuration and, once released from the overtube used to deliver the tube 150, the tube 150 bends into a predetermined curved shape. When ends 152 and 154 are exposed from within the muscle 14, ends 152 and 154 deform so that these ends 152 interlock with each other, and the tube 150 self-locks. End 152 has a thread 156 that screws into and interlocks with the housing 158 of end 154. In some applications, the end portion 152 is provided with a barb (not shown) that hooks onto the inner surface of the housing 158. In some applications, the longitudinal member 28 slides within the lumen of the tube 150. In some applications, the longitudinal member 28 is wound in a loop around a portion of the tube 150.

[0497] Refer here to Figures 10A to 10E, schematic diagrams of a system 160 comprising a leaflet gripping element 162 having projections 168 that function as staples, according to some applications. The leaflet gripping element 162 is coupled to a longitudinal member 28. The leaflet gripping element 162 is configured to be coupled to the edge 12 of the leaflet 10. The leaflet gripping element 162 comprises a first snap element 164 and a second snap element 166. In some applications, as shown, the first snap element 164 and the second snap element 166 each comprise a plate. In some applications, the plate includes a metal plate, and in some applications, the metal plate is covered with cloth. The leaflet gripping element 162 is shown as a snap clasp, not limiting it, but exemplifying it, and may comprise staples, clips, spring anchors, or other tissue anchors known in the art. The leaflet gripping element 162 is configured to grip the leaflets 10 of the atrioventricular valves of a patient's heart. In some applications, the atrioventricular valve includes an artificial valve. In some applications, the atrioventricular valve includes a tricuspid valve.

[0498] The first snap element 164 is positioned on the atrial surface of the valve leaflet 10, and the second snap element 166 is positioned on the ventricular surface of the valve leaflet 10. The positioning of elements 164 and 166 causes the tissue of the valve leaflet 10 to be grasped or snapped between elements 164 and 166. In some applications, snapping elements 164 and 166 together traps a portion of the tissue of the valve leaflet 10 between the first snap element 164 and the second snap element 166.

[0499] In some applications, the first snap element 164 and the second snap element 166 are made of a biocompatible metal such as nitinol or stainless steel.

[0500] The delivery tool 170 is used to deliver the first snap element 164 and the second snap element 166 to the edge 12 of the valve leaflet 10. The delivery tool 170 comprises a long tube having a static tubular element 172 and a movable tubular element 174 connected to each other by longitudinal elements, for example, a track, which allows the movable tubular element 174 to move easily relative to the static tubular element 172. The static tubular element 172 holds the first snap element 164, and the movable tubular element 174 holds the second snap element 166. As shown in Figure 10A, the static tubular element 172 and the movable tubular element 174 are spaced apart from each other so that the tubular elements 172 and 174, and the snap elements 164 and 166, can be positioned at the edge 12 of the valve leaflet 10. Furthermore, the separation of tubular elements 172 and 174 holds the first snap element 164 and the second snap element 166 apart. As shown in Figure 10B, the movable tubular element 174 is moved closer to the static account element 172 so that it can grip the edge 12 of the valve leaflet 10 between tubular elements 172 and 174, and between snap elements 164 and 166. In some applications, the movement of the movable tubular element 174 joins the first snap element 164 and the second snap element 166 so that they snap together.

[0501] The first snap element 164 comprises an upper element or an upper planar element, which, when the upper element or upper planar element contacts the tissue of the valve leaflet 10, secures the element 164. As shown, the first snap element 164 punctures the valve leaflet 10 with each projection 168 of the first snap element 164. The projections 168 are passable through each space 167 defined by the second snap element 166. As shown in Figure 10B, when the projections 168 of the first snap element 164 engage with the space 167 of the second snap element 166, the first snap element 164 locks into place relative to the second snap element 166.

[0502] In some applications, the second snap element 166 may have a projection 168, and the second first element 164 may be molded to define a space 167.

[0503] As shown in Figure 10C, when the projection 168 of the valve leaflet 10 punctures the tissue and engages within the space 167, the excess portion of the projection 168 downstream of the second snap element 166 deforms and curves toward the second snap element 166 to lock the first snap element 164 and the second snap element 166 into place. In this way, the valve leaflet gripping element 162 functions as a staple. In some applications, the surgeon manually deforms the projection 168 so that it curves upward. In some applications, the projection 168 is made of a shape-memory material that curves upward when no force is applied to the projection 168.

[0504] In some applications, the longitudinal member 28 is coupled to a first snap element 164 at its first end. Note that the longitudinal member 28 may also be coupled to a second snap element 166 instead. The longitudinal member 28 extends upstream of the valve so that its second end is accessible from the outside of the body (Figure 10C). The anchor delivery tool 176 is passed along the longitudinal member 28 as shown in Figure 10D to deliver the tissue anchor 175 to the papillary muscle 14. The anchor 175 includes an anchor head 177 shaped to define an eyelet 179 for advancing the anchor 175 against the longitudinal member 28. The anchor driver 178 is reversibly coupled to the anchor 175 to deploy the anchor into the papillary muscle 14. As shown, the anchor 175 includes a helical anchor, not limiting it, but exemplifying it. The anchor 175 may comprise any suitable anchor, for example, the tube described herein with reference to Figure 9. Once the longitudinal member 28 is fixed to the muscle 14, the tension of the member 28 can be adjusted, and the longitudinal member 28 is locked in place against the muscle 14, for example, using beads, locks, or crimps.

[0505] In some applications, at least one longitudinal member 28 extends from a lower valve leaflet gripping element 162 through the ventricle of the heart and is coupled to the papillary muscle 14 of the heart using, for example, any suitable tissue anchor known in the art. The longitudinal member 28 functions as an artificial chordae tendineae. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises a suture. In some applications, the longitudinal member 28 comprises at least one portion comprising at least one wire / suture portion and an elongated tension-applying coil. For example, the longitudinal member 28 may comprise an elongated coil between two wire / suture portions.

[0506] Hereinafter, we refer to Figures 11A-11B, schematic diagrams of a system 180 for generating a helical stitch on the edge of a single valve leaflet 10, according to some application examples. As shown in Figure 11B, the central portion 182 of the longitudinal member 28 is helically sutured to the edge 12 of the valve leaflet 10. Thus, the central portion 182 defines the leaflet gripping element. The helical stitch is made using a suture needle or any other rigid element coupled to the first end 185 of the longitudinal member 28 and is helically sutured to the edge 12 of the valve leaflet 10 multiple times. As the rigid element or suture needle helically passes through the tissue of the valve leaflet 10, it helically sutures the longitudinal member 28 to the valve leaflet 10 by screwing the portion of the longitudinal member 28 through the valve leaflet 10. After suturing the central portion 182, the first portion 184 of the longitudinal member 28 is then extended into the ventricle. The first portion 184 is downstream of the central portion 182 of the longitudinal member 28. Next, the first end 185 of the longitudinal member 28 is connected to the tissue surrounding the ventricle, for example, the papillary muscle 14, as shown in Figure 11A. For example, the first end 185 is tied to the muscle 14 or held in place by locking or crimping. In some applications, the first end 185 is connected to a tissue anchor, for example, a barbed or helical tissue anchor, or any other suitable tissue anchor known in the art.

[0507] In some applications, the second end 187 of the longitudinal member 28 is connected to the valve leaflet 10, for example, by tying it to the leaflet 10, or by being held in place by beads, locks, or crimping (configurations not shown). Optionally, the second portion 186 of the longitudinal member 28 upstream of the central portion 182 then extends into the ventricle. The second end 187 of the longitudinal member 28 is then connected to the tissue surrounding the ventricle, for example, the second papillary muscle 14, as shown in Figure 11B. For example, the second end 187 is tied to the muscle 14 or held in place by locks or crimping. In some applications, the second end 187 is connected to a tissue anchor, for example, a barbed or helical tissue anchor, or any other suitable tissue anchor known in the art. In some applications, a tissue anchor, such as a barbed or helical tissue anchor, or any other suitable tissue anchor known in the art, is screwed along the second portion 186 to bond the second end 187 to the muscle tissue 14.

[0508] Before securing the second end 187, the longitudinal member 28 is pulled to adjust the tension on it. The tension on the longitudinal member 28 is maintained by locking the second end 187 of the longitudinal member 28.

[0509] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0510] Herein, we refer to Figures 12A-C, schematic diagrams of a system 190 for generating a helical stitch on the edge of a single valve leaflet 10, according to some application examples. The central portion 194 of the longitudinal member 28 is helically sutured to the edge 12 of the valve leaflet 10, as shown in Figure 12B. In this way, the central portion 194 defines a valve leaflet gripping element. The helical stitch is made using a suture needle coupled to the first end 197 of the longitudinal member 28, or any other rigid element such as a helical tissue anchor 192 that is helically sutured multiple times to the edge 12 of the valve leaflet 10. The helical anchor 192 passes helically through the tissue of the valve leaflet 10 (as shown in Figure 12A), so that the longitudinal member 28 is helically sutured to the valve leaflet 10 by the portion of the longitudinal member 28 being helically sutured through the valve leaflet 10. After suturing the central portion 194, the first portion 196 of the longitudinal member 28 is extended into the ventricle. The first portion 196 is downstream of the central portion 194 of the longitudinal member 28. Next, the first end 197 of the longitudinal member 28 is joined to the tissue surrounding the ventricle, for example, the papillary muscle 14, using a helical anchor 192, as shown in Figure 12B.

[0511] In some applications, the second end 199 of the longitudinal member 28 is coupled to the valve leaflet 10, for example, by tying it to the leaflet 10, or by being held in place by beads, locks, or crimps (configurations not shown). Optionally, the second portion 195 of the longitudinal member 28 upstream of the central portion 194 then extends into the ventricle. The second end 199 of the longitudinal member 28 is then coupled to the tissue surrounding the ventricle, for example, the second papillary muscle 14 as shown in Figure 12C. For example, the second end 199 is tied to the muscle 14 or held in place by locks or crimps (configurations not shown). In some applications, the second end 199 is coupled to a tissue anchor, for example, a barbed or helical tissue anchor 198, or any other suitable tissue anchor known in the art. In some applications, a tissue anchor, such as a barbed or helical tissue anchor 198, or any other suitable tissue anchor known in the art, is screwed along the second portion 195 to bond the second end 199 to the muscle tissue 14.

[0512] Before securing the second end 199, the longitudinal member 28 is pulled to adjust the tension on it. The tension on the longitudinal member 28 is maintained by locking the second end 199 of the longitudinal member 28.

[0513] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0514] Herein, we refer to Figure 13, a schematic diagram of a system 200 for grasping a valve leaflet 10 using a leaflet grasping element 202, which includes a stent element 204 configured to surround the junction 203 between the innate chordae tendineae and the valve leaflet 10, in some application examples. The stent element 204 comprises struts that are collectively formed such that the more the stent element 204 is pulled along its longitudinal axis, the stronger its gripping force on the tissue becomes. As the stent element 204 is pulled along its longitudinal axis, its length increases, its width decreases, and its gripping force on the tissue increases. The stent element 204 is connected at the first end of each longitudinal member 28 to one or more (e.g., multiple, as shown) longitudinal members 28. The second end of each longitudinal member 28 is connected to a second stent element 206 configured to surround the papillary muscle 14. The stent element 206 comprises struts that are collectively formed such that the more the stent element 206 is pulled along its longitudinal axis, the stronger its gripping force on the tissue becomes. As the stent element 206 is pulled along its longitudinal axis, its length increases and its width decreases, thereby increasing its grip on the tissue.

[0515] In this way, stent elements 204 and 206 grasp the tissue without puncturing or damaging it. In some applications, stent elements 204 and 206 function as latch-end effectors.

[0516] In some applications, each of the stent elements 204 and 206 is molded as a semi-tubular stent with a "C"-shaped cross-section so that the stent elements 204 and 206 can be positioned around the tissue. In some applications, each of the stent elements 204 and 206 is provided with a cuff. The stent elements 204 and 206 are then secured in place using a chock or any appropriate lock. In some applications, the stent elements 204 and 206 have overlapping elements that lock into place once the elements 204 and 206 surround the tissue. In some applications, the stent elements 204 and 206 are provided with a return to help secure the stent elements 204 and 206 to the tissue.

[0517] Stent elements 204 and 206 may be positioned on a fractured or intact natural chordae tendineae. A longitudinal member(s) 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member(s) 28 comprises sutures. The longitudinal member(s) 28 comprises a flexible and / or superelastic material, e.g., ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member(s) 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member(s) 28 comprises at least one portion comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member(s) 28 may have a long coil between two wire / suture portions.

[0518] The tension of the longitudinal member 28 is controlled by pulling distally on the second stent element 206.

[0519] Herein, refer to Figures 14A to 14C, schematic diagrams of a system 210 for gripping a valve leaflet 10 by passing a valve leaflet tissue anchor 212 through the valve leaflet 10, according to some applications. The valve leaflet tissue anchor 212 defines a valve leaflet gripping element. As shown, the valve leaflet tissue anchor 212 is molded to define an upper element or planar upper element 214 coupled to a long longitudinal element 216. The long longitudinal element 216 is positioned at a non-zero angle, e.g., perpendicular, to the upper element or planar upper element 214. The distal end of the long longitudinal element 216 is molded to define a sharp distal tip 218 configured to puncture the tissue of the valve leaflet 10. The valve leaflet tissue anchor 212 may be made of a rigid biocompatible material, such as nitinol or stainless steel. In some applications, the valve leaflet tissue anchor 212 may be made of plastic.

[0520] The leaflet tissue anchor 212 is initially fixed to the leaflet 10 by puncturing it from the atrial surface using its tip 218. A portion of the leaflet tissue anchor 212, namely the long longitudinal element 216, passes through the tissue of the leaflet 10.

[0521] As illustrated, the leaflet tissue anchor 212 is shaped to define a long lumen for the longitudinal member 28 to pass through. Note that in some applications, the leaflet tissue anchor 212 is not shaped to define a lumen; for example, the leaflet tissue anchor 212 is solid, and the longitudinal member 28 is coupled to the leaflet tissue anchor 212 by a long longitudinal element 216. In any application, following the fixation of the leaflet tissue anchor 212 to the leaflet 10, the longitudinal member 28 extends upstream of the valve so that the end of the longitudinal member 28 is accessible from outside the body. The anchor delivery tool 176 is passed along the longitudinal member 28 to deliver the tissue anchor 175 (e.g., a ventricular tissue anchor) to the papillary muscle 14, as shown in Figure 14A and as described above herein with reference to Figure 10D. The anchor 175 includes an anchor head 177 shaped to define an eyelet 179 for advancing the anchor 175 into the longitudinal member 28. An anchor driver 178 is reversibly coupled to the anchor 175 to deploy the anchor into the papillary muscle 14. As shown, the anchor 175 includes a helical anchor, not limiting it, but exemplifying it. The anchor 175 may include any suitable anchor, for example, the tube described herein with reference to Figure 9.

[0522] Once the longitudinal member 28 is fixed to the muscle 14, the tension of the member 28 can be adjusted, and the longitudinal member 28 can be locked in place against the muscle 14, for example, using a lock, such as a bead or a lock or crimp, and against the valve leaflet 10, using a lock 215, for example, a bead or a lock or crimp. As shown in Figure 14B, the tension adjustment tool 217 is then introduced into the ventricle and, for example, uses a snare to grasp the longitudinal member 28 and facilitates pulling, tightening, and crimping of the longitudinal member 28. The longitudinal member is then locked in place with a lock 219, for example, a bead or crimp.

[0523] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0524] Hereinafter, refer to Figures 15A-15B, schematic diagrams of a system 220 for gripping a valve leaflet 10 by passing a valve leaflet tissue anchor 222 through the valve leaflet 10, according to some applications. The valve leaflet tissue anchor 222 defines the valve leaflet gripping elements. As shown in Figure 15B, in its stationary state, the valve leaflet tissue anchor 222 is shaped to define an upper element or planar upper element 226 and a long longitudinal element 228. The long longitudinal element 228 is positioned at a non-zero angle, e.g., perpendicular, to the upper element or planar upper element 226. In some applications, the valve leaflet tissue anchor 222 includes a biocompatible metal, e.g., nitinol or stainless steel, which comprises a plurality of struts arranged to impart flexibility, compressibility, and expandability to the valve leaflet tissue anchor 222. In some applications, the valve leaflet tissue anchor 222 comprises a fabric comprising a plurality of twisted yarns. In some applications, the leaflet tissue anchor 222 comprises a plastic having a woven yarn of multiple twisted threads. In some applications, in its stationary state, the leaflet tissue anchor 222 may be molded to define an hourglass shape, that is, the leaflet tissue anchor 222 may have an upper element or a lower planar lower element similar to the planar upper element 226.

[0525] The leaflet tissue anchor 222 is compressible within the delivery tube 221, as shown in Figure 15A. The needle 224 is positioned distal to the leaflet tissue anchor 222 and is exposed from within the tube 221, so that the needle 224 punctures and penetrates the leaflet 10. As the tube 221 passes through the hole in the leaflet 10, the tube passes through the leaflet 10 and through a portion of the leaflet tissue anchor 222, such as the long longitudinal element 228. The tube 221 then retracts completely to expose the upper element or planar upper element 226 on the atrial surface of the leaflet 10, so that the upper element or planar upper element 226 expands against the atrial surface.

[0526] In some applications, the needle 224 passes through the ventricle and reaches the papillary muscle 14, where it punctures the muscle 14 and delivers a tissue anchor, such as a ventricular tissue anchor, to the muscle 14. In some applications, the needle 224 itself is the anchor, such as a barb, and remains implanted.

[0527] In some applications, the leaflet tissue anchor 222 is shaped to define a long lumen for the passage of the longitudinal member 28. Note that in some applications, the leaflet tissue anchor 222 is not shaped to define a lumen, and the longitudinal member 28 is connected to the leaflet tissue anchor 222 by a long longitudinal element 228.

[0528] In some applications, after the valve leaflet tissue anchor 222 is fixed to the valve leaflet 10, the longitudinal member 28 is fixed to the tissue surrounding the ventricle, for example, the papillary muscle 14. In some applications, the longitudinal member extends upstream of the valve so that the end of the longitudinal member 28 is accessible from outside the body, and an anchor delivery tool can be passed along the longitudinal member 28 to deliver the tissue anchor to the papillary muscle 14, as described above with reference to Figure 14A and Figure 10D. The anchor in the muscle 14 may include, but not limited to, a helical anchor. The anchor may include any suitable anchor, for example, the tube shown above here with reference to Figure 9.

[0529] Once the longitudinal member 28 is fixed to the muscle 14, the tension of the longitudinal member 28 can be adjusted, and to maintain the tension of the longitudinal member 28, the longitudinal member 28 is locked in place using, for example, beads, locks, or crimps.

[0530] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0531] Here, we refer to Figures 16A to 16C, schematic diagrams of a system 230 for gripping a valve leaflet 10 by passing a valve leaflet tissue anchor 232 through the valve leaflet 10, in some applications. The valve leaflet tissue anchor 232 defines the valve leaflet gripping element. As shown in Figure 16B, in its stationary state, the valve leaflet tissue anchor 232 is shaped to define an upper element or planar upper element 234, a long longitudinal element 236 positioned distal to the upper element or planar upper element 234, and a distal structural element 238. The long longitudinal element 236 is positioned at a non-zero angle, e.g., perpendicular, to the upper element or planar upper element 234. The distal structural element 238 is shaped to define a tapered element, e.g., a cone with a distal sharp tip. In some applications, the distal structural element 238 is configured to puncture and pass through the tissue of the valve leaflet 10. Alternatively, or additionally, the valve leaflet 10 can be punctured using a needle (e.g., a needle 224, as shown in Figures 15A-15B and as described herein with reference to Figure 10D) before the distal structural element 238 is passed through the valve leaflet 10. In applications where the needle is used before passing the anchor 232 through the valve leaflet 10, the distal structural element 238 and anchor 232 can be shaped into any other shape, for example, a planar disc, to form an hourglass configuration.

[0532] In some applications, the leaflet tissue anchor 232 comprises a biocompatible metal such as nitinol or stainless steel, which comprises multiple supports arranged to impart flexibility, compressibility, and expandability to the leaflet tissue anchor 232. In some applications, the leaflet tissue anchor 232 comprises a fabric comprising a plurality of twisted yarns. In such applications, the distal structural element 238 may comprise a rigid material that can be punctured and passed through the leaflet 10. Alternatively or additionally, a needle can be used to puncture the leaflet 10 before passing the distal structural element 238 through the leaflet 10. In some applications, the leaflet tissue anchor 232 comprises a plastic comprising a plurality of twisted yarns. In some applications, in its stationary state, the leaflet tissue anchor 232 may be molded to define an hourglass shape, i.e., the leaflet tissue anchor 232 may comprise an upper element or a lower or lower plane element similar to a planar upper element 234.

[0533] As shown in Figure 16A, the leaflet tissue anchor 232 is compressible within the delivery tube 231. As shown, the distal structural element 238 of the leaflet tissue anchor 232 is exposed from within the tube 231, and as a result, the distal structural element 238 punctures and penetrates the leaflet 10. The tube 231 penetrates the hole in the leaflet 10, and as a result, the tube passes through the leaflet 10 and through a portion of the leaflet tissue anchor 232, such as the distal structural element 238 and the elongated longitudinal element 236, etc. The tube 231 then retracts completely so that the upper element or planar upper element 234 is exposed on the atrial surface of the leaflet 10, so that the upper element or planar upper element 234 expands against the atrial surface.

[0534] As shown in the figure, the longitudinal member 28 is connected to the leaflet tissue anchor 232 by the distal structural element 238. In some applications, the leaflet tissue anchor 232 is shaped to define a long lumen for passing through the longitudinal member 28 (configuration not shown).

[0535] Following the fixation of the valve leaflet tissue anchor 232 to the valve leaflet 10, the longitudinal member 28 extends upstream of the valve, so that the end of the longitudinal member 28 is accessible from outside the body. The anchor delivery tool 176 passes along the longitudinal member 28, as shown in Figure 16B and as described herein with reference to Figure 10D, to deliver the tissue anchor 175 (e.g., a ventricular tissue anchor) to the papillary muscle 14. The anchor 175 comprises an anchor head 177 shaped to define an eyelet 179 for screwing the anchor 175 into the longitudinal member 28. The anchor driver 178 is reversibly coupled to the anchor 175 to deploy the anchor into the papillary muscle 14. As shown, the anchor 175 comprises a helical anchor, not limiting, but illustrative. The anchor 175 may comprise any suitable anchor, e.g., a tube as described herein with reference to Figure 9.

[0536] Once the longitudinal member 28 is fixed to the muscle 14, the tension of the longitudinal member 28 can be adjusted, and to maintain the tension of the longitudinal member 28, the longitudinal member 28 is locked in place using, for example, beads, locks, or crimps.

[0537] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0538] Refer here to Figures 17A-17B, schematic diagrams of a system 240 comprising a leaflet stabilization element 242 configured to hold and stabilize a valve leaflet 10, according to some application examples. The leaflet stabilization element 242 is configured to pass between the leaflet of the atrioventricular valve and the leaflet gripping edge 12 to hold and stabilize the leaflet 10 when procedures are performed, such as grasping the leaflet 10, pinching the leaflet, puncturing the leaflet, and / or puncturing the leaflet using any of the leaflet gripping elements described herein or any other tool used with a leaflet 10 known in the art. The leaflet stabilization element 242 is configured to provide a reaction force to the leaflet 10 during the procedure, for example, by applying temporary tension and / or adjustment to the leaflet 10. Once the procedure on the leaflet 10 is complete, the grip of the leaflet stabilization element 242 on the leaflet 10 is released, and the leaflet stabilization element 242 is removed from the patient's body.

[0539] The leaflet stabilization element 242 comprises a long tube having, for example, a static tubular element 244 and a movable tubular element 246 connected to each other by a longitudinal element 248, so that the movable tubular element 246 can easily move relative to the static tubular element 244. As shown in Figure 17A, the static tubular element 244 and the movable tubular element 246 are spaced apart from each other to allow positioning of the edge 12 of the leaflet 10 between the tubular elements 244 and 246. As shown in Figure 17B, the movable tubular element 246 moves closer to the static compensating element 244 so that it can grasp the edge 12 of the leaflet 10 between the tubular elements 244 and 246. This movement can be controlled by the surgeon who is outside the patient's body. The gripping of the leaflet stabilization element 242 is reversible. In some applications, the movable tubular element 246 is slidable along its longitudinal axis toward the static compensating element 244.

[0540] Refer here to Figures 18A-18B, schematic diagrams of a system 250 comprising a leaflet stabilization element (e.g., a clasp) 252 configured to hold and stabilize the leaflet 10, according to some application examples. The leaflet stabilization element 252 is configured to pass between the leaflets of the atrioventricular valve and grip the edge 12 to hold and stabilize the leaflet 10 when procedures are performed, such as grasping the leaflet 10, pinching the leaflet, puncturing the leaflet, and / or puncturing the leaflet using any of the leaflet grasping elements described herein or any other tool used on the leaflet 10 known in the art. The leaflet stabilization element 252 is configured to provide a reaction force to the leaflet 10 during the procedure, for example, by applying temporary tension and / or adjustment to the leaflet 10. Once the procedure on the leaflet 10 is complete, the grip of the leaflet stabilization element 252 on the leaflet 10 is released and the leaflet stabilization element 252 is removed from the patient's body.

[0541] The leaflet stabilization element 252 comprises a long tube having an upper clamping element (e.g., an upstream support) 254 and a lower clamping element 256 (e.g., a downstream support), connected to each other by a hinge 258, which facilitates the movement of the upper clamping element 254 and the lower clamping element 256, for example, by swirling. As shown in Figure 18A, the upper clamping element 254 and the lower clamping element 256 are spaced apart from each other to allow positioning of the edge 12 of the leaflet 10 between the upper clamping element 254 and the lower clamping element 256. As shown in Figure 18B, the upper clamping element 254 and the lower clamping element 256 move together to allow gripping of the edge 12 of the leaflet 10 between the upper clamping element 254 and the lower clamping element 256. This movement can be controlled by the surgeon outside the patient's body. The gripping of the leaflet stabilization element 252 is reversible.

[0542] Refer here to Figures 19A-19B, schematic diagrams of a system 260 comprising a leaflet stabilization element (e.g., a clasp) 262 configured to hold and stabilize the leaflet 10, according to some applications. The leaflet stabilization element 262 is configured to pass between the leaflet of the atrioventricular valve and the leaflet gripping edge 12 to hold and stabilize the leaflet 10 when procedures are performed, such as grasping the leaflet 10, pinching the leaflet, puncturing the leaflet, and / or puncturing the leaflet using any of the leaflet gripping elements described herein or any other tool used on the leaflet 10 known in the art. The leaflet stabilization element 262 is configured to provide a reaction force to the leaflet 10 during the procedure, for example, by applying temporary tension and / or adjustment to the leaflet 10. Once the procedure on the leaflet 10 is complete, the grip of the leaflet stabilization element 262 on the leaflet 10 is released, and the leaflet stabilization element 262 is removed from the patient's body.

[0543] The valve leaflet stabilization element 262 comprises a long wire 268 coupled to an expandable support 264 at its distal end. The long wire 268 extends outside the patient's body, and its proximal end is accessible from outside the patient's body by a surgeon who controls the movement of the wire 268 to properly position the expandable support 264. In some applications, the expandable support 264 and wire 268 are deliverable to the valve within a delivery tube. In such applications, the expandable support 264 is compressible within the delivery tube. The expandable support 264 comprises a flexible material such as plastic, nitinol, or stainless steel. The expandable support 264 is molded to define a plurality of fingers 266 that fan out relative to each other, configured to increase the contact area between the expandable support 264 and the valve leaflet 10.

[0544] The wire 268 is delivered between the valve leaflets, thereby positioning the expandable support 264 within the ventricle. In applications where the expandable support 264 can be delivered within a tube, the tube retracts to expose the expandable support 264 within the ventricle. In either application, once inside the ventricle, the fingers 266 of the expandable support fan are curved relative to each other, as shown in Figure 19A. The surgeon then pulls the wire 268 proximal to draw the expandable support toward the ventricular surface of the valve leaflet 10, as shown in Figure 19B. Maintaining a grip on the wire 268, the fingers 266 are pressed against the ventricular surface of the valve leaflet 10 to provide stability to the valve leaflet 10 from the ventricular surface side. When the fingers 266 are pressed against the ventricular surface of the valve leaflet 10, the fingers 266 straighten out. As long as the wire 268 is pulled in a proximal direction, the support 264 supports the valve leaflet 10. Once the procedure on the valve leaflet 10 is complete, the surgeon releases the tension on the wire 268, releasing the grip on the ventricular surface of the valve leaflet 10. Next, the wire 268 is pulled, and the support 264 removes the wire 268 from the patient's body.

[0545] Herein, we refer to Figures 20A to 20I, schematic diagrams of a system 270 comprising an elongated tool 272 for facilitating valve leaflet installation in some application examples. The tool 272 comprises a central tube (271) having a central longitudinal axis. The central tube (271) is shaped to define a lateral slot 277. The tool 272 comprises at least one needle 278 that is slidable within the lumen of the central tube (271). Figure 20C shows an exemplary implementation of the tool 272 comprising two needles, namely a first needle 278 and a second needle 278 that are slidable within the lumen of the central tube (271). The tool 272 comprises a lower structural element 274 (i.e., a downstream support) on the ventricular surface of the valve leaflet 10, configured to position the valve leaflet 10 so that it is placed within the lateral slot 277. The tool 272 comprises at least one needle stabilizing element 276 (e.g., an upstream support) that is movable along the longitudinal axis of the central tube (271). Figure 20C shows an exemplary implementation of the tool 272 comprising a first needle stabilizing element 276 and a second needle stabilizing element 276 that are movable along the longitudinal axis of the central tube (271).

[0546] Figure 20A shows the tool 272 approaching the valve leaflet 10. In Figure 20B, the first needle stabilizing element 276 and the second needle stabilizing element 276 are moved distally by pushing their respective distal shafts, which are coupled to the first and second needle stabilizing elements 276, distally. In Figure 20C, the first and second needle stabilizing elements 276 are pushed in sufficiently so that a portion of the edge of the valve leaflet 10 is gripped between the first and second needle stabilizing elements 276 and the lower structural element 274. Thus, the needle stabilizing elements 276 and the lower structural element 274 collectively define a clasp configured to grip a portion of the valve leaflet 10 so that an anchor can be easily secured to the portion of the valve leaflet. At this point, the needle 278 has not yet moved distally.

[0547] Each needle 278 has a sharp distal tip. In some implementations, each needle 278 includes a slanted tip 400 (see, for example, Figure 23A) which includes a sharp distal tip portion 402 and a proximal tip portion 404.

[0548] In Figure 20D, the needle 278 moves distally by sliding within the lumen of the central tube (271). The distal tip portion 402 of the needle 278 passes through the openings 279 (shown in Figure 20A) of the first and second needle stabilizing elements 276, which loosely surround and stabilize the needle 278 as the needle 278 passes through them. The distal tip portion 402 of the needle 278 is the punctured tissue of the valve leaflet 10. As the needle 278 is continuously pressed distally, the needle 278 passes through the tissue of the valve leaflet 10 and the respective slots 273 (shown in Figure 20A) of the substructure element 274.

[0549] The central tube (271) is configured to easily deliver the flap 281 of the leaflet dilating patch 280 (e.g., a planar flap, a non-planar flap, a flat flap, a thin flap, a long flap, etc.) to the leaflet 10. The flap 281 is coupled to the needle 278 by pushing the needle 278 distally, so that the flap 281 moves distally and is carried to the lateral slot 277 of the tube 271. The patch 280 (e.g., its flap 281) is then exposed from inside the tube 271 through the lateral slot 277 (Figure 20D).

[0550] Figure 20E is a cross-sectional side view of tool 272 as shown in the configuration in Figure 20D.

[0551] The flap 281 comprises a flexible sheet of biocompatible material that mechanically resembles or mimics the innate tissue of the valve leaflet 10, so that the flap 281 can expand the valve leaflet 10 and enhance the function of the valve leaflet 10 and the junction of the valve leaflet 10 with the opposing valve leaflet 10. In some applications, the flap 281 comprises tissue, for example, pericardial tissue. In some applications, the flap 281 comprises a sheet of polymer, such as polyethylene, expanded polytetrafluoroethylene, or polyethylene terephthalate, for example, a sheet of such polymer fabric. In some applications, the flap 281 comprises an organic and / or inorganic material that collectively provides the characteristics of flexibility, shape memory durability, impermeability, and peri-implant tissue growth stimulation.

[0552] In Figure 20F, the flap 281 is moved distally and folded at the edge 12 of the valve leaflet 10. The patch 280 comprises at least one tension member coupled to the flap 281. Figure 20H shows an exemplary implementation of the patch 280 comprising two tension members (e.g., cords) 284, i.e., first and second flap deformation elements coupled to the flap 281. In some applications, the tension members 284 are screwed into the flap 281. The tension members 284 can pass through the flap 281 according to various stitching or sewing patterns, such as threading through at least one penetration point through the thickness of the flap 281, or stitching in an in-and-out stitching pattern. In some applications, the tension members 284 extend through a channel formed within the flap 281. In some applications, the tension members 284 comprise a fiber or polymer thread.

[0553] The tension members 284 are coupled at their respective ends to the joints 286, i.e., the edges of the flap 281, to the respective first ends of the longitudinal members 28 (e.g., tethers). In some applications, each joint 286 includes a coupling member, such as an eyelet or ring, to which both the tension members 284 and the respective longitudinal members 28 are attached. In some applications, the tension members 284 are either tied to the flap 281 at the joints 286 or loosely tied. In some applications, both tension members 284 are coupled to a single longitudinal member 28. The longitudinal member 28 is pulled into the ventricle, and the respective second ends of the longitudinal member 28 are coupled to the surrounding tissue of the ventricle, such as the wall of the ventricle or papillary muscle 14, as shown in Figure 20I.

[0554] In some applications, the tension member 284 can be further utilized to help the flap 281 transition from the folded state shown in Figures 20F to 20G to the extended configuration shown in Figure 20H, thus acting as a flap deformation element. In some applications, the tension member 284 comprises a shape memory material, such as nitinol, which has shape memory to help the flap 281 self-expand and transition from the folded state shown in Figures 20F to 20G to the extended configuration shown in Figure 20H. In some applications, the tension member 284 comprises a wire.

[0555] In some applications, tension is applied to the tension member 284 by pulling the longitudinal member 28, helping the flap 281 deform in an expanded configuration. In some applications, the tension member extends beyond the joint 286 and functions as the longitudinal member 28. That is, the tension member 284 is longer than the patch 280 and is drawn into the ventricle. Each second end of the tension member 284 is connected to the tissue surrounding the wall of the ventricle, for example, the ventricular or papillary muscle 14. By pulling the tension member 284, tension is applied to the flap 281 by the tension member 284, helping the flap 281 deform in an expanded configuration. At least one locking element (e.g., a patch anchor or stopper) can pass at least one needle 278 toward the ventricular surface of the valve leaflet 10. The at least one locking element can be of various shapes and is configured to press against the ventricular surface of the valve leaflet 10 and prevent spontaneous disengagement between the at least one locking element and the valve leaflet 10. In some applications, the locking element 282 may have any suitable anchor and may have any suitable crimping or crushing function. In some applications, the at least one locking element includes a rod-shaped locking element 282 (e.g., a toggle anchor), as shown in Figures 20F to 20G, and shows two rod-shaped elements, i.e., a first and a second locking element 282. The rod-shaped locking element 282 may be tubular.

[0556] In Figures 20F to 20G, the first and second locking elements 282 are pushed against the ventricular surface of the valve leaflet 10 by passing through the needle 278. Each of the locking elements 282 is coupled to the respective first ends of the first and second tension members 284. In some applications, the rod-shaped locking element 282 comprises a long element configured such that its longitudinal axis is substantially perpendicular to the atrial or ventricular surface of the valve leaflet 10 and reverses from a substantially perpendicular orientation parallel to the longitudinal axis of the needle 278, while the locking element 282 is positioned within the needle 278 during penetration through the valve leaflet 10, and when the locking element 282 unfolds from within the needle 278 and is pressed against the ventricular surface of the valve leaflet 10, its longitudinal axis becomes substantially upper lateral in orientation substantially parallel to the ventricular surface of the valve leaflet 10.

[0557] In some applications, the locking element 282 is compressible when delivered into each lumen of the hollow needle 278, and once pushed out of the needle 278 and exposed therefrom, it comprises a T-shaped locking element that expands into a T shape. When expanded on the ventricular surface of the valve leaflet 10, at least one locking element, such as the rod-shaped locking element 282, locks the flap or planar flap 281 into place relative to the valve leaflet 10. For example, at least one locking element can be helical once it has expanded from a linear configuration when the at least one locking element is positioned within the needle 278.

[0558] Next, as shown in Figure 20H, the tool 272 is pulled away from the valve leaflet 10, thereby pulling the longitudinal member 28, which in some applications allows for smoother straightening and expansion of the flap 281. Then, the tool 272 is moved inside the ventricle to draw the longitudinal member 28 into the ventricle. Next, as shown in Figure 20I, the longitudinal member 28 is attached to the ventricle, for example, the tissue surrounding the papillary muscle 14.

[0559] The flap 281 is illustrated, not as an example but as an illustration, as substantially rectangular. For example, as described below herein with respect to patch 610, the flap 281 may be substantially trapezoidal. In some applications, the flap 281 has an inner edge 390 of the flap (e.g., root lateral edge) defined as an edge positioned over the leaflet 10 facing the valve annulus, and a free edge 394 of the flap (e.g., lip) which may be defined as an opposing edge of the flap 281 positioned spaced apart from (e.g., beyond) the edge 12 of the leaflet 10. The flap 281 may further define a lateral edge 392 of the flap (i.e., a lateral edge) extending between the inner edge 390 and the free edge 394 of the flap. In some applications, the joint 286 is located at or near the free edge 394 of the flap. In some applications, the joint 286 is coupled to the free edge 394 of the flap. Ultimately, the system 270 provides a non-traumatic device that facilitates leaflet dilation, aimed at making it easier to join and attach or strengthen the valve leaflets to treat regurgitation. Furthermore, the system 270 provides artificial chordae tendineae, i.e., longitudinal members 28 and / or tension members 284. The combination of leaflet dilation, such as via the attachment of the leaflet dilation pathway 280 to the leaflet 10, provided by a single system 270, and artificial chordae tendineae such as the longitudinal member 28, may be advantageous over partial solutions that provide only the leaflet dilation function of artificial chordae tendineae, or systems that require separate procedures performed for each, and systems that utilize different systems.

[0560] It should be noted that the suture can be sutured to the valve leaflet 10, and the patch 280 can be slid over the suture. For example, using tool 272, the suture positioned on the valve leaflet 10 can first be attached to the valve leaflet 10, and the patch 280 can be slid along the suture to either the atrial or ventricular surface of the valve leaflet 10.

[0561] Refer here to Figures 21A–21C, schematic diagrams illustrating additional exemplary configurations and applications of the leaflet expansion patch 280 of system 270. In some applications, the leaflet expansion patch 280 comprises a support frame 380 preferably coupled to the edge of the flap 281 and then to the flap 281. In some applications, the support frame may include a polymer wire frame or a stainless steel wire frame that provides additional support to the flap 281. In some applications, the support frame 380 acts as a flap deformation element by transitioning the flap 281 from a folded state (Figures 20F–20G) to an expanded configuration (such as the configuration shown in Figure 21A). In some applications, the support frame 380 comprises a shape memory material, such as nitinol, which has shape memory to help the flap 281 self-expand and transition from a folded state (also called a compressed configuration) to an expanded configuration. The support frame 380 is illustrated, not as an example but as an example, as a substantially rectangular frame. In some applications, the support frame 380 comprises an inner edge 382 of the frame coupled to the flap 281 along the inner edge 390 of the flap, and a free edge 386 of the frame coupled to the flap 281 along the free edge 394 of the flap. The frame 380 may further define a lateral edge 384 of the frame extending between the inner edge 382 and the free edge 386 of the frame. In some applications, the joint 286 is located at or near the free edge 386 of the frame. In some applications, the joint 286 is coupled to the free edge 386 of the frame.

[0562] As described herein, at least one tension member 284 can be coupled to the flap 281 in a variety of ways. In some applications, as shown in Figures 21A-21C, the tension member 284 extends through channels 396 formed within and along the flap 281. In some applications, the at least one tension member 284 may be suture (e.g., single-filament or multi-filament suture), flexible wire (e.g., metal wire formed from stainless steel, nitinol or other suitable metal), cable (e.g., braided cable formed from metal or polymer strands), a piece of material (e.g., polymer or metal piece), or other similar material that can be bent and rest under stress (e.g., under tension) between a joint 286 where the tension member 284 is coupled to a longitudinal member 28 and at the opposite end is coupled to a locking element 282.

[0563] As shown in Figure 21B, when the longitudinal member 28 is pulled distally, tension is applied to the tension member 284, which then transmits that tension to the locking element 282, pressing them against the ventricular surface of the valve leaflet 10. This works to the advantage of reducing the tension on the longitudinal member 28 from the flap 281.

[0564] In some applications, the leaflet expansion patch 280 may include a spring configured to compress and shorten any excess length of the leaflet expansion patch 280 and / or tension member 284. In some applications, the support frame 380 further serves as a spring-type biasing member configured to compress and shorten any excess length of the leaflet expansion patch 280 and / or tension member 284.

[0565] Figure 21C shows a leaflet expansion patch 280 attached to a leaflet having a greater thickness than the leaflet thickness illustrated in Figure 21C. Each tension member 284 is placed under tension between its ends (i.e., between the attachment to the longitudinal member 28 and the attachment to the locking element at the joint 286), so its overall length does not change regardless of the thickness of the leaflet 10 through which it extends. Therefore, if the leaflet is thicker, the proportion of the length of the tension member 284 that passes through or extends along the flap 281 becomes smaller. This can result in a shorter flap 281 between the joint 286 of the leaflet 10 and the atrial surface compared to the length of the flap 281 in Figure 21B, as shown in Figure 21C. The support frame 380 can shorten the flap 281 when the joint 286 and the tension member 284 are subjected to a compressive force between the region extending through the valve leaflet 10 and the flap 281, and can extend or enable the extension of the flap 281 when such force is absent. For example, the support frame 380 may include a compression spring.

[0566] Here, Figures 22A and 22B are schematic diagrams of additional exemplary applications of the system 270 and the configuration of the leaflet expansion patch 280. In some applications, at least one tension member comprises a single locking element 282, as shown in Figure 22A. In such applications, the elongated tool 272 may include a single needle 278 through which the tension member 284 can be advanced, a single needle stabilizing element 276, and a single tension member 284 with one end coupled to the locking element 282 and the other end coupled to a single longitudinal member 28 (e.g., at a single joint 286). Any other implementations of the system 270 and the leaflet expansion patch 280 disclosed with respect to Figures 20A to 21C, 23A to 26E, and 31A to 66D can be implemented by means of a single locking element (i.e., a single patch anchor) as well as two or more locking elements (i.e., two or more patch anchors).

[0567] Figures 22A to 22B further illustrate, not limitingly but exemplifying, another configuration for connecting the tension member 284 to the flap 281, the tension member 284 extending from the locking element, through the valve leaflet 10, toward the flap 281, through the flap 281, and further extending from there along its upper surface over a portion of the flap 281, and then penetrating through the flap 281 toward the underside of the flap 281, to be connected to the longitudinal member 28 at the joint 286. It should be understood that any connection configuration between the tension member 284 and the flap 281, comprising the front-to-back stitching shown in Figures 22A to 22B, or the extension through the channel 396 shown in Figures 21A to 21C, can be used in combination with any other example of the system 270 or the valve leaflet expansion patch 280 disclosed by means of Figures 20A to 25F.

[0568] The attachment of the leaflet enlargement patch 280 to the leaflet 10 can be performed and observed under fluoroscopy or other imaging methods. During such a procedure, it may be desirable to retrieve the leaflet enlargement patch 280, for example, if its position is unsuitable for the leaflet 10. In some applications, the system 270 further includes a patch retrieval mechanism configured to facilitate the retrieval of the leaflet enlargement patch 280 after it has been coupled to the leaflet 10 via at least one locking element, for example, locking element 282.

[0569] Herein, we refer to Figures 23A to 23E, schematic diagrams of a system 270 equipped with a patch retrieval mechanism for facilitating the retrieval of a valve leaflet dilation patch 280, according to some applications. According to some applications, the system 270 further comprises at least one tension member (e.g., retrieval thread) 388 that is directly or indirectly releasably coupled to at least one locking element. The at least one tension member 388 may comprise a polymer or fibrous thread, a flexible wire, or a flexible cable.

[0570] As shown in Figure 22, the tension member 388 extends through the lumen of the central tube (271) and is movable along its central longitudinal axis through the central tube (271). In some applications, each locking element, such as a rod-shaped locking element 282, is equipped with an eyelet 289 attached to one end thereof, through which each tension member 388 is looped (see Figure 23B).

[0571] According to some applications, the central tube (271) is a multi-lumen tube having at least two lumens, one of which a longitudinal member 28 may extend, and another of which a tension member 388 may extend, in order to avoid any potential entanglement between the longitudinal member 28 and the tension member 388 which extends longitudinally through the central tube (271).

[0572] While the locking element 282 is held within the needle 278, the tension member 388 extends backward from the eyelet 289 of the locking element 282, over the edge of the inclined tip 400 of the needle 278, and through the lumen of the central tube (271), so that it extends to the outside of the patient's body, for example, so that the proximal end of the tension member 388 is accessible from outside the patient's body by the surgeon controlling the movement of the tension member 388. In some applications, the distal tip portion 402 of each inclined tip 400 of the needle 278 is sharp, while the proximal tip portion 404 remains blunt, thereby reducing or eliminating the risk of accidentally cutting off a portion of the tension member 388 folded over it.

[0573] Figure 23C shows the expanded configuration in which the valve leaflet expansion patch 280 is coupled to the valve leaflet 10, while the tension member 388 and longitudinal member 28 still extend toward the central tube (271). The longitudinal tool 272 and central tube (271) are not shown in Figure 23C, but it should be understood that at the stage shown in Figure 23C, the longitudinal tool 272 and central tube (271) are moving toward the valve leaflet 10 to a position similar to that shown, for example, in Figure 20H. As shown, each of the tension members 388 is looped through its respective eyelet 289, with one twisted thread 389 of each tension member 388 extending from one side of its respective eyelet 289 and the other twisted thread 389 extending from the other side of the same eyelet 289. All of the twisted sutures 389 extend from the eyelet 289 through the leaflet 10 toward the central tube (271) between the atrial surface of the leaflet 10 and the lower surface of the flap 281.

[0574] Figure 23D shows a potential follow-up step to retrieve the leaflet enlargement patch 280 if, for example, the position on the leaflet 10 is determined to be inappropriate. As shown, both strands 389 of each tension member 388 are pulled in the proximal direction, thereby reorienting the locking element 282 from the locking direction shown in Figure 23C to a non-parallel direction, i.e., at an angle or perpendicular to the leaflet 10. Applying further tension to the tension members 388, more specifically to both strands 389 of each tension member 388, pulls the locking element 282 through the leaflet 10, and ultimately pulls the patch 280 along it toward and potentially into the elongated tool 272. Applying the proximal-oriented tension to the longitudinal member 28 parallel to the tension applied to the tension member 388 facilitates patch retrieval.

[0575] Figure 23E shows an alternative tracking step compared to Figure 23C, where, if the position of the patch 280 on the valve leaflet 10 is appropriate, the tension member 388 may be detached from the locking element 282 and retrieved, although such retrieval is not mandatory. In such a case, one twist 389 of each tension member 388 can be pulled out proximal, while the other twist can move freely distally toward the eyelet 289 until it is released from the eyelet 289, so that the pull member 388 is no longer looped through the eyelet 289 and can be retrieved from there.

[0576] Herein, we refer to Figures 24A to 24C, schematic diagrams of alternative retrieval mechanisms for facilitating the retrieval of the valve leaflet enlargement patch 280 in some applications. According to some embodiments, as shown in Figure 24A, a single tension member 388 can be joined by a U-shaped loop 406 attached to a first locking element 282 and a second locking element 282. As shown, the U-shaped loop 406 may have a first tail portion 408 attached at its ends to the first locking element 282 and the second locking element 282, and a central curved portion 410 defined between the second tail portion 408, over which the tension member 388 is looped. In this configuration, one twisted thread 389 extends from one side of the U-shaped loop 406, and the other twisted thread extends from the other side of the U-shaped loop 406.

[0577] The first U-shaped tail portion 408 and the second U-shaped tail portion 408 may be coupled to the first and second locking elements via eyelets 289, or may be directly attached thereto by any number of methods known in the art, such as suturing, bonding, or welding. The first and second tail portions 408 and the second tail portion 408 extend from the locking element 282 through the thickness of the valve leaflet 10 and toward the central tube (271) between the atrial surface of the valve leaflet 10 and the lower surface of the flap or planar flap 281.

[0578] Figure 24B shows a potential follow-up step to retrieve the leaflet enlargement patch 280 if, for example, its position on the leaflet 10 is determined to be inappropriate. As shown, both strands 389 are pulled simultaneously in the proximal direction, pulling the U-shaped loop 406 along it, and acting to reorient the locking element 282 from the locking orientation shown in Figure 24A to a non-parallel, i.e., angled or orthogonal orientation with respect to the leaflet 10. Applying further tensile force on the pulling member 388, more specifically on both strands 389, pulls the locking element 282 through the leaflet 10, and ultimately acts to pull the patch 280 along it toward and potentially into the elongated tool 272. To further facilitate patch retrieval, a tensile force oriented proximal to the longitudinal member 28 can be applied parallel to the tensile force applied to the pulling member 388.

[0579] Figure 24C shows an alternative tracking step compared to Figure 24A, where, if the position of patch 280 on the valve leaflet 10 is appropriate, the tension member 388 may be detached from the U-shaped loop 406 and retrieved, although such retrieval is not mandatory. In this case, one twisted thread 389 can be pulled proximal, while the other twisted thread moves freely distally toward the rotating portion 410 of the U-shaped loop 406 until it is released from there, so that the tension member 388 is no longer looped through the U-shaped loop 406 and can be retrieved from there.

[0580] Figure 24D shows the leaflet expansion patch 280 coupled to the leaflet 10 after the retrieval of the tension member 388. Preferably, the U-shaped loop 406 is dimensioned such that the central curved portion 410 does not extend beyond the free edge 394 of the flap 281, so that the entire U-shaped loop 406 is hidden beneath the flap 281.

[0581] In implementations utilizing multiple locking elements 282, the configurations shown in Figures 24A to 24C may be more advantageous than those shown in Figures 23A to 23E because the number of tension members 388 required is less than the number required to be manipulated during the procedure. For example, when a patch 280 connected to a valve leaflet 10 via two locking elements 282 uses a U-shaped loop 406 as shown in Figures 24A to 24, only one tension member 388 is required instead of the two tension members 388 that need to be pulled simultaneously in the configurations shown in Figures 23A to 23E.

[0582] Herein, we refer to Figures 25A to 25F, schematic diagrams of another type of system 270 having a retrieval mechanism for facilitating the retrieval of the valve leaflet expansion patch 280 in some applications. According to some applications, at least one locking element is provided in the form of at least one expandable locking element 283. The expandable locking element 283 may include a braided member.

[0583] As shown in Figure 25A, the expandable locking element 283 is molded in its stationary state to define a long, longitudinal (e.g., tubular) element. When deployed within the needle 278, the expandable locking element 283 is in its free state and may not expand due to the limitations of the inner wall surrounding the needle 278. In some applications, the expandable locking element 283 comprises a biocompatible metal, such as nitinol or stainless steel, with a plurality of supports arranged to impart flexibility, compressibility, and expandability to the expandable locking element 283. In some applications, the expandable locking element 283 comprises a fabric comprising a plurality of twisted yarns. In some applications, the expandable locking element 283 comprises a plastic comprising a plurality of twisted yarns.

[0584] Each type of locking element, comprising a rod-shaped locking element 282 and an expandable locking element 283, includes a proximal end 285 and a distal end 287.

[0585] Each tension member 284 is coupled at one end to the respective distal end 287 of the locking element 283, and at the opposite end to the longitudinal member 28 at the joint 286. In the illustrated example, the tension members are shown to be sutured through the flap 281 at two penetration points. However, it is clear that any other coupling configuration between the tension members 284 and the flap 281 is also intended.

[0586] The length of each tension member 284 is such that when the flap or planar flap 281 is in the expanded configuration shown in Figure 25B, the distal end 287 of the locking element is pulled proximal toward the ventricular surface of the visceral valve leaflet 10 by the tension member 284 that applies tensile force thereto, causing the expandable locking element 283 to assume an expanded orientation or configuration (e.g., any substantially flat, expanded, disk-like orientation / configuration) having a maximum outer diameter larger than the diameter of the expandable locking element 283 in its free state.

[0587] In some applications, the ends of the tension member 284 may be directly joined to the distal end 287 of the locking element, for example, by welding, suturing, or bonding. In some applications, the ends of the tension member 284 include a biasing element 275 that extends beyond the diameter of the distal end 287 of the locking element when the expandable locking element 283 is free, so that when the tension member 284 is subjected to tension, the biasing element 275 is pressed against the distal end 287 of the locking element while being pulled in the proximal direction, thereby causing the expandable locking element 283 to transition to an expanded orientation or configuration (e.g., substantially planar, disc-like orientation / configuration) that is pressed between the biasing element 275 and the ventricular-side surface of the valve leaflet 10. The biasing element 275 may take the form of an elongated rod, disc, washer, plate, etc., which may be attached to the distal end 287 of the locking element (e.g., suture, bond, and / or weld), or may be positioned below (i.e., distally) the distal end 287 of the locking element.

[0588] According to some embodiments, the system 270 further comprises a tension member 388 which is releasably coupled to a portion of the flap 281, for example, near the inner edge 390 of the flap, or to a portion of the flap 281 facing the joint 286. In some applications, the tension member 388 is sutured through the portion of the flap 281 facing the joint 286, for example, by being sutured through the thickness of the flap 281 near the inner edge 390 of the flap.

[0589] Figure 25D shows a potential follow-up step where, if the position of the patch 280 on the valve leaflet 10 is appropriate, the tension member 388 may be detached from the flap 281 and retrieved, although such retrieval is not mandatory. In such an example, one end of the twisted thread 389 can be pulled proximal, while the other end can move freely distally toward the flap 281 until it is released from there, so that the tension member 388 no longer passes through the flap 281 and can be retrieved from there. Figure 25E shows the leaflet expansion patch 280 attached to the valve leaflet 10 after the tension member 388 has been removed therefrom.

[0590] Figure 25F shows an alternative follow-up step for retrieving the leaflet expansion patch 280 if, for example, its position on the leaflet 10 is determined to be inappropriate. By pulling the first longitudinal member 28 proximal, for example, toward a long tool 272, as shown in the figure, the flap 281 transitions to the folded U-shaped state shown in Figure 25E. In some applications, the long tool 272 can be repositioned so that when a proximal tensile force is applied to the longitudinal member 28, the flap 281 transitions to the desired folded state on the leaflet 10.

[0591] By moving the flap 281 to a folded state, the free edge 394 of the flap approaches the inner edge 390, and as a result, there is no longer any tension between the tension members 284, and the expandable locking element 283 can freely assume a free state and transition to its elongated longitudinal shape. In this state, both ends of the flap 281 can be pulled toward the elongated tool 272 by simultaneously applying proximal oriented tensile forces on the tension members 284 and the pulling member 388, while the locking element 283 is pulled through the valve leaflet 10, allowing for the retrieval of the valve leaflet expansion patch 280.

[0592] Figure 25F further illustrates two embodiments of an expandable locking element 283 in which the proximal end 285 of the locking element is formed to have a tapered shape that allows for smooth retraction of the locking element 283 through the valve leaflet 10. In some applications, the proximal end 285 of the locking element is formed to be a conical or frustoconical shape that tapers in the proximal direction. This can be achieved by shaping the support of the proximal end 287 of the locking element by heat treatment or other means to make it tapered radially inward in the proximal direction. In some applications, the locking element 283 includes a shrinkage portion 288 attached to the proximal end 287 of the locking element. The shrinkage portion 288 is formed as a conical or frustoconical ring and is tapered radially inward in the proximal direction.

[0593] Although illustrated with the expandable locking element 283, it should be understood that any other type of locking element having a rod-shaped locking element 282 may have a tapered proximal end by means of a shape-forming locking element or by connecting a contraction portion (288) to it. As the tapered locking element follows its proximal end, the proximal end of the locking element acts as an expansion wedge mechanism that pulls the locking element through the thickness of the valve leaflet 10, allowing for the smooth retrieval of the leaflet expansion patch (280) by any mechanism described by means of Figures 23A-23D, 24A-24D, and / or 25A-F.

[0594] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0595] Herein, refer to Figures 26A-E, schematic diagrams of a system 290 for implanting artificial chordae tendineae using an elongated implantation tool 292, in some application examples. The elongated implantation tool 292 comprises an upper tubular portion 294 and a lower tubular portion 296. The tool 292 is molded to define a lateral slot 297 between the upper tubular portion 294 and the lower tubular portion 296. The tool 292 is delivered between the leaflets of the atrioventricular valve so that the lateral slot 297 is positioned between the leaflets. As shown in Figure 26A, the tool 292 is positioned and manipulated so that a single leaflet 10 moves within the lateral slot 297 of the tool 292, with the upper tubular portion 294 positioned in the atrium and the lower tubular portion 296 positioned in the ventricle.

[0596] The tool 292 is supported within a longitudinal member 28 that functions as an artificial chordae tendineae within its lumen. The longitudinal member 28 extends through the tool 292 such that a first end 301 and a second end 303 are disposed within a lower tubular section 296. Each end 301 and 303 of the longitudinal member 28 is coupled to the respective needles 304 and 306. The lower tubular section 296 is shaped to define needle holders 305 and 307, each configured to hold the respective needles 304 and 306. Each portion 300 and 302 of the longitudinal member 28 extends from the respective ends 301 and 303 of the longitudinal member 28. In some applications, the tool 292 is shaped to define a respective lumen (not shown) for passing through each portion 300 and 302 of the longitudinal member and / or for passing through the respective needles 304 and 306.

[0597] The tool 292 includes a needle receptacle 298 disposed within the lumen of the upper tubular portion 294 and slidable therewith. The needle receptacle 298 may be made of plastic or rubber through which the needles 304 and 306 can pass. In some applications, the needle receptacle 298 is molded to define the respective lumens for receiving the needles 304 and 306, respectively. The needle receptacle 298 is movable within the lumen of the upper tubular portion 294 by a rod 299 coupled to the needle receptacle 298. As shown in Figure 26B, the needle receptacle 298 is moved by the rod 299 toward the distal end of the upper tubular portion 294 and toward the atrial surface of the valve leaflet 10.

[0598] As shown in Figure 26C, the tool 292 moves the needles 304 and 306 upward by moving the needle holders 305 and 307 proximal and parallel to the ventricular surface of the valve leaflet 10, so that the needles 304 and 306 puncture the valve leaflet 10 from the ventricular surface and travel through the valve leaflet 10 toward the atrium of the heart. The needle receiver 298 receives the needles 304 and 306. As shown in Figure 26D, the needle receiver 298 then moves proximal to suture the suture portions 300 and 302 of the longitudinal member 28 through the valve leaflet 10, so that the curved portion 308 of the longitudinal member 28 is positioned toward the ventricular surface of the valve leaflet 10.

[0599] Next, the tool 292 is pulled away from the valve leaflet 10, and the longitudinal member 28 is pulled along with it, so that portions 300 and 302 overlap the lip of the valve leaflet 10, as shown in Figure 26E. The ends 301 and 303 are attached to the tissue surrounding the ventricle, for example, the papillary muscle 14, as shown. The longitudinal member 28 is attached to the muscle 14 via a tissue anchor 175, as shown. The anchor 175 may comprise any suitable anchor, for example, the tube described herein with reference to Figure 9. Once the longitudinal member 28 is fixed to the muscle 14, the tension of the member 28 can be adjusted, and the longitudinal member 28 is locked in place against the muscle 14, for example, using beads, locks, or crimps. In some applications, the longitudinal member 28 may be sutured to the muscle 14 or tied to the muscle 14.

[0600] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0601]

[0001] The systems and leaflet enlargement patches described in relation to Figures 20A to 26E (individually or as subassemblies), as well as their features and components, can be used in combination with or mutatis mutandis to replace the systems and leaflet enlargement patches described in relation to Figures 31A to 66D. Furthermore, the systems and leaflet enlargement patches described in relation to Figures 20A to 26E (individually or as subassemblies), as well as their features and components, can be adapted to include the features and / or components of the systems and leaflet enlargement patches described in relation to Figures 31A to 66D.

[0602] Herein, refer to Figures 27A–27D, schematic diagrams of the system 310 or artificial chordae tendineae implantation using the docking element 312 in some application examples. A long docking element delivery tool 313 is delivered between the leaflets of the atrioventricular valve. The tool 313 includes an oversheath 311 formed to define a lumen to accommodate the docking element 312 while delivering the docking element 312 to the tissue surrounding the ventricle, enabling non-traumatic delivery of the docking element 312 to the tissue. As shown, the docking element 312 is bound to the papillary muscle 14 tissue. Note that the docking element 312 may be bound to the ventricular wall tissue.

[0603] The docking element 312 is molded to define a tubular element that defines a receptacle having a lumen through its interior. In some applications, the docking element 312 is molded to define a receptacle having any suitable shape. The docking element 312 is molded to define a sharp distal tip 314 that penetrates the tissue of the muscle 14. It should be noted that the docking element 312 may have any suitable tissue anchors, such as helical anchors, clips, or barbs. In some applications, a portion of the docking element 312 can surround the papillary muscle 14, for example, as described above herein with reference to Figure 13. The docking element 312 is molded to define one or more openings 316.

[0604] As shown in Figure 27B, the tissue anchor delivery tool 322 is delivered to the atrial surface of the valve leaflet 10. The tool 322 carries a tissue anchor 320 in its lumen, which is formed to define a tubular element and a sharp distal tip 321. The tip 321 is configured to puncture and pass through the tissue of the valve leaflet 10. The tissue anchor 320 is coupled to the first tip of a longitudinal member 28. As the tissue anchor 320 passes through the valve leaflet 10, the first portion of the longitudinal member 28 passes through the valve leaflet 10 via the tissue anchor delivery tool 322 and enters the ventricle. The tissue anchor 320 advances via the tissue anchor delivery tool 322 toward the docking element 312 implanted in the muscle 14. The tissue anchor delivery tool 322 comprises an oversheath 323. The tissue anchor 320 comprises one or more expandable projections 324 that are compressed within the oversheath 323 while the tissue anchor 320 is passed toward the docking element 312.

[0605] The docking element 312 has an outer diameter at least 1.2 times larger than the outer diameter of the tissue anchor 320. In some applications, the docking element 312 has an outer diameter at least 1.5 times larger than the outer diameter of the tissue anchor 320. In this way, the docking element 312 and the tissue anchor 320 are delivered to the papillary muscle 14 at each stage in such a way that damage to the tissue of the valve leaflet 10 is minimized. That is, because the outer diameter of the docking element 312 is larger than the outer diameter of the tissue anchor 320, the docking element 312 is not delivered through the tissue of the valve leaflet 10, but rather the docking element 312 is delivered between the valve leaflets to avoid passing a larger diameter element through the tissue of the valve leaflet 10. Only the element with a smaller diameter, i.e., the tissue anchor 320, is delivered through the tissue of the valve leaflet 10. As shown in Figure 27B, the tissue anchor 320 approaches the docking element 312 that has already been implanted in the papillary muscle 14.

[0606] In Figure 27C, the tissue anchor 320 advances within the receptacle of the docking element 312. By advancing the tissue anchor 320 within the docking element 312, the tissue anchor 320 and the first end of the longitudinal member 28 connect to the docking element 312. During connection, one or more projections 324 of the tissue anchor 320 align with one or more openings 316 of the docking element 312. Once aligned, the projections 324 expand through the one or more openings 316, allowing the tissue anchor 320 to be secured to the docking element 312. Once expanded, the projections 324 function as a return to facilitate the fixation of the tissue anchor 320 to the muscle 14 tissue.

[0607] The second end of the longitudinal member 28 is connected to the valve leaflet 10. As shown in the figure, the second end of the longitudinal member 28 is connected to the atrial surface of the valve leaflet 10 using a locking element 326, for example, cotton thread. Note that the locking element 326 may have any suitable locking, such as beads or crimping. In some applications, the longitudinal member 28 is sutured or tied to the valve leaflet 10. In some applications, the tension of the longitudinal member 28 is adjusted by connecting and locking the longitudinal member 28 to the valve leaflet 10. For example, the longitudinal member 28 is pulled until a desired tension is reached, and that tension is maintained by locking the longitudinal member 28 in place using the locking element 326.

[0608] In some applications, the tension of the longitudinal member 28 is adjusted following its locking into place relative to the valve leaflets 10. As shown in Figure 27C, the tension adjustment tool 331 advances between the valve leaflets and engages with the longitudinal member 28, for example, the snare. The tension adjustment tool 331 is used to pull the longitudinal member 28 until the desired tension level of the longitudinal member 28 is reached. The tension adjustment tool 331 tightens and compresses the longitudinal member 28.

[0609] Figure 27D shows how the longitudinal member 28 is secured in place and the tension applied to the longitudinal member 28 is ensured. As shown in the figure, the longitudinal member 28 is secured in place using the crimp 328.

[0610] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0611] Hereinafter, we refer to Figures 30A to 30C, schematic diagrams of a system 370 comprising a leaflet gripping element 372 configured to hold and grip the leaflet 10, according to some application examples. The leaflet gripping element 372 is configured to pass between the leaflets of the atrioventricular valve to hold and grip the leaflet 10, for example, by pinching and / or puncturing the leaflet, and to grip the edge of the leaflet 12. The leaflet gripping element 372 consists of an upper gripping element 374 and a lower gripping element 376 connected to each other by a hinge 373 that allows the upper gripping element 374 and the lower gripping element 376 to move easily. As shown in Figure 30A, the upper gripping element 374 and the lower gripping element 376 are spaced apart from each other so that the edge 12 of the leaflet 10 can be positioned between the upper gripping element 374 and the lower gripping element 376. As shown in Figure 30B, the upper and lower clamping elements 374 and 376 move together to allow the edge 12 of the valve leaflet 10 to be grasped between them. This movement can be controlled by the surgeon outside the patient's body.

[0612] The upper clamping element 374 is equipped with a sharp post 375, which has a sharp distal end and is configured to puncture and pass through the tissue of the valve leaflet 10. The lower clamping element 376 is molded to define an opening or receiving element configured to receive the sharp post 375. Note that the lower clamping element 376 may be equipped with a sharp post 375, but the upper clamping element 374 is molded to define an opening or receiving element to receive the sharp post 375.

[0613] The hinge 373 is operably controlled by a control structure 378 coupled to the tube 379. The control structure 378 is positioned to maintain the clamping elements 374 and 376 in an open state, as shown in Figure 25A. When the tube 379 is withdrawn, the control structure 378 is pulled to operate the hinge 373 to close the clamping elements 374 and 376, as shown in Figure 30B.

[0614] The longitudinal member 28 is connected at its first end to the leaflet gripping element 372. As shown in Figure 25C, when the leaflet gripping element 372 is clamped onto the leaflet 10 to grip it, the longitudinal member 28 is retracted into the ventricle, and the second end of the longitudinal member 28 is connected to the tissue surrounding the ventricle, for example, the papillary muscle 14, as shown. The second end of the longitudinal member 28 is connected to the muscle 14 using any suitable anchor, for example, a helical anchor or a barb. By pulling the longitudinal member 28, tension is applied to the longitudinal member 28. Once sufficient tension is applied, the connection of the second end of the longitudinal member 28 to the muscle 14 maintains the tension applied to the longitudinal member 28. As the tension in the longitudinal member 28 is maintained, it holds the leaflet gripping element 372 in a clamped closed state, as shown in Figure 30C. By applying tension to the longitudinal member 28, the tension is applied to and maintained in the longitudinal member, thereby preventing the valve leaflet gripping element 372 from opening.

[0615] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0616] Refer here to Figures 28A to 28C, schematic diagrams of a system 330 comprising a curved cardiac tissue penetration element 332 configured to facilitate leaflet dilation and chordae tendineae repair in some applications. The curved cardiac tissue penetration element 332 comprises at least one curved rigid element 336. As shown, the curved cardiac tissue penetration element 332 comprises two curved rigid elements 336 joined to each other by a bridge 334. Each curved rigid element 336 has a distal sharp tip 338 with a plurality of ribs 340. In some applications, the curved rigid element 336 is shaped to define an "S"-shaped curve. In some applications, the curved rigid element 336 is shaped to define an elongated "S"-shaped curve. In some applications, the curved cardiac tissue penetration element 332 includes a metal, such as nitinol or stainless steel, and is rigid.

[0617] As shown in Figure 28A, the curved cardiac tissue penetration element 332 punctures cardiac tissue from the atrial surface of the atrioventricular valve in the patient's heart, with the distal sharp tip 338 of the curved rigid element 336. In some applications, the distal sharp tip 338 of the curved rigid element 336 punctures the tissue of the valve annulus 16. Since the annulus 16 is thicker than the tissue of the valve leaflets 10 and can withstand the tension of the curved cardiac tissue penetration element 332 on the annulus 16, puncturing the tissue of the annulus 16 allows for smoother and more efficient bonding of the curved cardiac tissue penetration element 332.

[0618] The distal, sharp tip 338 passes through the tissue of the annulus 16 toward the ventricular surface of the atrioventricular valve.

[0619] As shown in Figure 28B, the ventricular surface of the valve leaflet 10 is punctured by the sharp distal tip 338, and as a result, the tip 338 penetrates the valve leaflet 10, for example, from the ventricular and atrial surfaces of the atrioventricular valve, as shown, toward the atrial surface of the valve leaflet 10. In some applications, the surgeon manually manipulates the curved cardiac tissue penetration element 332 through the cardiac tissue according to the curved shape of the curved cardiac tissue penetration element 332. In some applications, the curved cardiac tissue penetration element 332 has shape memory that allows the tip 338 of the curved cardiac tissue penetration element 332 to self-penetrate the atrial surface of the atrioventricular valve, pass through the ventricular surface, penetrate the ventricular surface of the valve leaflet 10, and emerge at the atrial surface of the valve leaflet 10.

[0620] As shown in Figure 28B, a portion of the curved cardiac tissue penetration element 332 passes through the valve annulus 16, enabling a firm connection between the curved cardiac tissue penetration element 332 and the cardiac tissue. Furthermore, the tissue of the valve annulus 16 can withstand the tensile force exerted by the curved cardiac tissue penetration element 332. Once curved, the cardiac tissue penetration element 332 is fixed to the valve annulus 16, and multiple barbs 340 are exposed on the atrial surface of the valve leaflet 10.

[0621] In Figure 28C, the artificial valve leaflet patch 344 is coupled to the return 340 and sharp tip 338 of the curved cardiac tissue penetration element 332. The patch 344 comprises a biocompatible material that resembles the innate tissue of the valve leaflet 10, allowing the patch 344 to expand the valve leaflet 10 and enhance the function of the valve leaflet 10 and the junction of the valve leaflet 10 with adjacent valve leaflets. In some applications, the patch 344 comprises tissue, e.g., pericardial tissue. In some applications, the patch 344 comprises a sheet of polyethylene, expanded polytetrafluoroethylene, or polyethylene terephthalate. In some applications, the patch 344 comprises an organic and / or inorganic material that collectively provides the characteristics of flexibility, shape memory durability, impermeability, and periimplant tissue growth stimulation.

[0622] In some applications, the return 340 hooks onto the material of the artificial valve leaflet patch 344. In some applications, the patch 344 includes a coupling 342 that is hooked onto by the return 340. In some applications, the coupling 342 includes sockets surrounding the sharp distal tip 338 of each curved rigid element 336 and the return 340.

[0623] The first end of at least one longitudinal member 28, for example, the first end of each of multiple longitudinal members 28, is connected to the edge of the patch 344. The longitudinal member 28 extends from the patch 344 into the ventricles of the patient's heart. The second end of at least one longitudinal member 28, for example, the second end of each of multiple longitudinal members 28, is connected to the tissue surrounding the ventricles. As shown, the second end of the longitudinal member 28 is connected to the papillary muscle 14. Note that the second end of the longitudinal member 28 may be connected to the tissue of the ventricular wall. The second end of the longitudinal member 28 is connected to a tissue anchor 346 which is connected to the papillary muscle 14. The tissue anchor 346 connects all ends of each of the multiple longitudinal members 28. As shown, the tissue anchor 346 surrounds the muscle 14. For example, the tissue anchor 346 has a cuff surrounding the muscle 14. In some applications, the tissue anchor 346 has a sharp tip that penetrates the tissue surrounding the ventricle.

[0624] The anchor 346 may comprise any suitable anchor, for example, the tube shown above herein with reference to Figure 9. Once the longitudinal member 28 is fixed to the muscle 14, the tension of the member 28 can be adjusted, and the longitudinal member 28 is locked in place against the muscle 14, for example, using beads, locks, or crimps. Thus, the system 330 provides a device, apparatus, and method for leaflet expansion and chordae tendineae repair / replacement. The curved cardiac tissue penetration element 332 can be viewed under imaging guidance, which helps to facilitate the proper positioning of the element of the system 330. By coupling the element 332 to the annulus 16, a system is provided that can be easily imaged and does not require grasping the leaflet 10 from the edge of the leaflet 10. By coupling the element 332 to the annulus 16, a system is provided that has increased capacity to withstand the tension of the patch 344 and the longitudinal member 28 on the cardiac tissue. Furthermore, the "S" shape of the element 332 prevents the element 332 from damaging the surrounding vascular system during implantation. The shape of element 332 and the joint portion 342 minimize the force acting on the valve leaflet 10, allowing the valve leaflet 10 to generally maintain its natural orientation and curve.

[0625] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one portion comprising at least one wire / suture portion and an elongated tension-applying coil. For example, each longitudinal member 28 may comprise an elongated coil between two wire / suture portions.

[0626] Figures 29A to 29C are schematic diagrams of a system 350 comprising a papillary muscle anchor 352 having a frame 351 bonded to a flexible sheet (e.g., cloth and / or polymer) 358, according to some applications. As shown in Figure 29A, the frame 351 of the papillary muscle anchor 352 comprises a central ring 354 bonded to a plurality of supports 356 arranged circumferentially with respect to a central ring 354. As shown, each support 356 is shaped to define a petal shape. As shown, the frame 351 is shaped to define a star or star shape. In some applications, the frame 351 comprises a metal, e.g., nitinol or stainless steel. In some applications, the frame 351 has shape memory. In some applications, the frame 351 has shape memory for being in a collapsed state. In some applications, the frame 351 has shape memory for being in an expanded state. The central ring 354 is shaped to define or to define a plurality of loops 355 that extend outward from the periphery of the central ring 354, for joining one or more longitudinal members 28 to the central ring 354.

[0627] In some applications, the polymer sheet 358 may include, for example, an absorbent material around the sheet 358, which helps to facilitate the sealing of the sheet 358 into the tissue and prevent blood from entering beneath the sheet 358.

[0628] As shown in Figure 29B, the polymer sheet 358 is bonded to the frame 351, for example, by sewing it to the frame 351 or by other means of bonding or attachment. The polymer sheet 358 comprises a non-porous, biocompatible polymer, such as a fabric. The braided and porous outlay of the polymer sheet 358 facilitates tissue growth to allow for further bonding between the papillary muscle anchor 352 and the cardiac tissue.

[0629] As shown in Figure 29C, a papillary muscle anchor 352 is specified to bond to the papillary muscle 14. However, it should be noted that the anchor 352 can bond to any suitable tissue other than the papillary muscle 14. For example, the anchor 352 can bond to a portion of the ventricular wall. The papillary muscle anchor 352 comprises a tissue anchor 362, or a tissue engaging member that bonds to cardiac tissue. As shown, the anchor 362 comprises helical tissue, not limiting it, but exemplifying it. The anchor 362 may comprise a return or any other suitable anchor known in the art. The anchor 362 is bonded to the central ring 354.

[0630] Anchor 352 is delivered into the ventricle within the sheath, with the frame 351 and sheet 358 in a collapsed state, causing the anchor 352 to collapse. The anchor 352 can be deployed and expanded from within the sheath. In some applications, the frame 351 has shape memory such that it self-expands once the anchor 352 is exposed from within the sheath. In some applications, the frame 351 tends to collapse and is manually opened during the implantation of anchor 362, after which it is allowed to self-collapse to cradle the tissue to which the anchor 362 is implanted. In the collapsed state, the frame 351 and polymer sheet 358 sandwich (i) the anchor 362 and (ii) the tissue between the frame 351 and the polymer sheet 358. The sheet 358 increases the contact area between the frame 351 and the papillary muscle 14.

[0631] The frame 351 and sheet 358 together function as a parasol, cradle the tissue to which the anchor 362 is implanted.

[0632] In any example where the frame 351 tends to expand or collapse, the porosity of the polymer sheet 358 is sufficiently low to promote tissue growth and endothelialization, while also providing resistance to intraventricular blood in such a way that the pressure from intraventricular blood helps to facilitate the force acting on the sheet 358 and frame 351 in a vector toward the tissue anchor 362. That is, the frame 351 and sheet 358 are maintained downward, i.e., perpendicular to the surface of the tissue to which the anchor 362 is implanted, in a configuration that continuously cradles the muscle 14 due to the pressure of the blood and ventricular pressure.

[0633] As shown in Figure 29C, when the anchor 352 is implanted in the papillary muscle 14, a longitudinal member 28, which is coupled to the ring 354 of the anchor 352, extends upward at its first end, and the second end of the longitudinal member 28 is coupled to the leaflet 10 by, for example, a leaflet tissue anchor 360 coupled to the second end of the longitudinal member 28. It should be noted that the leaflet tissue anchor 360 may comprise any leaflet gripping element described herein, or any other leaflet anchor known in the art. In some applications, the longitudinal member 28 is sutured or tied to the leaflet 10. It should be noted that the anchor 352 may be coupled to multiple longitudinal members 28. For such applications, the central ring 354 comprises multiple loops 355 (shown in Figure 29A) around its circumference, and each longitudinal member 28 is coupled to its respective loop 355. In some applications, the longitudinal members 28 are dispersed with respect to the valve leaflets 10, as referred herein with reference to Figures 5A-5B, 6A-6C, and 7A-7B.

[0634] The frame 351 is collapsible around tissue anchors in response to a force applied to the frame 351 by a vector toward the tissue anchors, for example, by a sheet 358. Alternatively, or additionally, the frame 351 is foldable by applying tension to the central ring 354. In some applications, tension is applied to the ring 354 by a longitudinal member 28. In some applications, tension is applied to the longitudinal member 28 when it is coupled to the valve leaflet 10, which helps to apply force to the ring 354 to help fold the frame 351 further around the muscle 14. Once tension is applied to the longitudinal member 28, it is locked in place and maintained by, for example, using an anchor 360. In some applications, tension can be applied to the longitudinal member 28 by, for example, crimping or chocks following coupling the longitudinal member 28 to the valve leaflet 10.

[0635] The longitudinal member 28 functions as an artificial chordae tendineae. In some applications, the longitudinal member 28 comprises sutures. The longitudinal member 28 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the longitudinal member 28 is coated with polytetrafluoroethylene (PTFE) or PTFE. In some applications, the longitudinal member 28 comprises at least one part comprising at least one wire / suture portion and a long tension-applying coil. For example, the longitudinal member 28 may have a long coil between two wire / suture portions.

[0636] The anchor 352 eliminates the need to penetrate deeply into the cardiac tissue because the frame 351 and sheet 358 reinforce the bond between the anchor 352 and the tissue. Furthermore, downward forces acting on the frame 351 and sheet 358, such as ventricular pressure during systole, cause the frame 351 and sheet 358 to continuously grip the cardiac tissue, minimizing the possibility of the anchor 352 detaching from the tissue.

[0637] Refer again to Figures 1A to 30C. Note that the systems described herein with reference to grasping the valve leaflets in Figures 1A to 8, 10A to 16C, 20A to 28C, and 30A to 30C can be used in combination with any anchors used to grasp the tissue surrounding the ventricle, for example, with reference to Figures 9, 11A to 14C, and 29A to 29C.

[0638] Refer again to Figures 1A to 30C. Note that the systems described herein with reference to gripping the valve leaflets in Figures 1A to 8, Figures 10A to 16C, and Figures 20A to 30C can be used in combination with any of the valve leaflet stabilization elements described herein with reference to Figures 17A to 19B.

[0639] Refer again to Figures 1A to 30C. Note that the tensions of the longitudinal members 28 and 64 can be adjusted using tension adjustment tools 217 and 331, or any other tension adjustment tools known in the art that follow during and / or after the transplantation of longitudinal members 28 and 64.

[0640] Hereinafter, refer to Figures 31A-31B, 32A-32Q, 33A-33B, and 34A-34C, which are schematic diagrams of the system 500 and the techniques for using the system to treat the heart 4 of a subject, according to some application examples. In particular, the system 500 is used to reduce (e.g., eliminate) regurgitation through the atrioventricular valve 7 of the heart, which is caused by suboptimal jointing of the valve leaflets. The system 500 comprises an implant 550 and a delivery tool 800 for delivering and implanting the implant.

[0641] Figure 31A shows system 500 having an implant 550 separate from the delivery tool 800, along with an exploded view of the delivery tool. Figure 31B shows system 500 assembled with the implant 550 mounted on the delivery tool 800. The implant 550 comprises a patch 610 and at least one patch anchor 640. The patch 610 and patch anchor 640 can be considered components of the upstream assembly 600 of the implant 550. The implant 550 further comprises a downstream assembly 700 and a tether 560 connecting the downstream assembly to the upstream assembly 600. Thus, in some applications, system 500 (e.g., its implant 550) has several features in common with system 270 described herein.

[0642] In some applications, the Tether 560 is equipped with sutures. In some applications, the Tether 560 is equipped with a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium. In some applications, the Tether 560 is coated with polytetrafluoroethylene (PTFE).

[0643] Inset A in Figure 31B is a perspective view showing the frame 630 within patch 610, but for clarity, inset B is not a perspective view. Inset B is a view of the opposite side of the apparatus shown inset A. Inset C in Figure 31B shows a cross-section of tool 800. For simplification, this cross-section of shaft 810 is shown as solid, although it is tubular, and it should be noted that other components, such as the drive shaft subassembly 890 (e.g., the drive shaft of the drive shaft subassembly), extend through its interior.

[0644] The patch 610 comprises a flexible sheet 620 and may further comprise at least one frame 630 to which the sheet is attached. The frame 630 can provide the patch 610 with mechanical properties that cannot be obtained with the sheet 620 alone. These properties will be described in more detail below. While this disclosure generally refers to a single sheet 620, the patch 610 may comprise multiple sheets arranged in layers, for example, by placing the frame 630 between the sheets. (This can be alternatively described as a sheet 620 comprising multiple layers, i.e., a multilayer sheet.)

[0645] In some applications, patch 610 shares characteristics with patch 280 and / or its flap 281 by analogy.

[0646] The implant 550 (for example, its upstream assembly 600) may comprise, for example, at least one patch anchor 640 coupled to the patch 610 as shown. However, in some applications (for example, some variants and / or systems 500 of the implant 550), the fixation of the patch may include coupling the patch anchor to the patch (for example, pushing the patch anchor through the patch), as described elsewhere in this specification.

[0647] The downstream assembly 700 comprises a winch 720 and a winch anchor 710 coupled to the winch. The winch anchor 710 has a tissue engagement element 712 configured to press into the tissue along the anchor axis ax2 of the winch anchor. In the illustrated example, the tissue engagement element 712 is a helical tissue engagement element configured to screw into the tissue along axis ax2. However, it should be noted that the winch anchor 710 may also be provided with other types of tissue engagement elements, such as darts, staples, and / or those described below herein with reference to Figures 54A to 59C.

[0648] The winch 720, equipped with a spool 722 (see, for example, Figures 33A-34C), can be mounted so that it and / or its axis of rotation are collinear with the anchor axis ax2, as shown. However, other spool orientations are also possible, as described with reference to, for example, Figure 60.

[0649] The tether 560 can tether the winch to the patch by being coupled to the patch 610 and extending from there to the winch 720. As shown, the tether 560 can enter the winch 720 through a lateral opening 726 of the winch housing 721 and / or reach the spool 722 in an orientation substantially orthogonal to the anchor axis ax2. Although the housing 721 is referred to as the housing of the winch 720, in some applications it can be considered the housing of the downstream assembly 700.

[0650] The tether 560 is operablely coupled to the winch 720 so that the operation of the winch can adjust the effective length of the tether, i.e., the length of the tether between the winch and the patch 610.

[0651] The delivery tool 800 has a transcatheter (e.g., transfemoral) distal portion 804 that can be advanced into the heart, and through thereafter, it may have an extracorporeal proximal portion 802 that may have a handle and / or control unit through which an operator (e.g., a physician) can control (e.g., orient, actuate, etc.) the components of the distal portion of the tool to deliver, for example, an implant 550. The delivery tool 800 comprises a shaft 810, a clasp 830, and at least one driver 850. In some applications, the shaft 810 may have features and / or functions similar to those of the tube 271 of the system 270 by analogy.

[0652] The delivery tool 800 may include an overtube 806 that defines a primary lumen 807 through which the shaft 810 extends and passes. The overtube 806 may also define one or more auxiliary lumens 808 that communicate with a distal portion 804 for one or more other components of the delivery tool 800 to extend inside.

[0653] The shaft 810 defines the longitudinal axis ax1 of the delivery tool 800. In some applications, as illustrated, the shaft 810 (and the lumen 807 on which it extends) may also be eccentric with respect to the overtube 806, and therefore, even if the longitudinal axis ax1 is centered with respect to the shaft 810, it may not be centered with respect to the entire delivery tool 800. In the shown embodiments, the auxiliary lumens 808 are generally located on one side of the primary lumen 807, and for example, they are circumferentially distributed around the primary lumen over a range of less than 220 degrees (e.g., less than 200 degrees, such as 180 degrees). This arrangement is advantageous in that it is easier to efficiently contain the clasp 830 within the overall diameter of the delivery tool 800. For example, as also illustrated, the clasp 830 may also be located on the same side of the shaft 810 on which the secondary lumen 808 is located.

[0654] The shaft 810 (e.g., its distal end) is advancing into the ventricle 8 downstream of the valve 7 (e.g., as will be described in more detail below). As shown in Figure 31B, the shaft 810 (e.g., its distal end) is coupled to the downstream assembly 700 of the implant 550. As will be described in more detail below, this coupling constitutes a delivery tool 800 that (i) fixes the winch anchor 710 to the ventricular tissue of the heart, and (ii) applies a fixing force to the winch anchor to actuate the winch 720. That is, the shaft 810 can remain coupled to the downstream assembly 700 throughout the fixation of the winch anchor 710 and the actuatement of the winch 720. Furthermore, as will be described in more detail below, the delivery tool 800 and the coupling of the shaft 810 to the downstream assembly 700 are configured so that the delivery tool can actuate the winch 720 independently of applying a fixing force to the winch anchor 710.

[0655] The clasp 830 comprises an upstream support 832 and a downstream support 834. The clasp 830 is transitionable between (i) an open state and (ii) a gripping state (e.g., a closed state). In the open state, the upstream support 832 and the downstream support 834 are positioned spaced apart from each other, so that the clasp is configured to receive a portion of the valve leaflet (e.g., valve leaflet 10) of the valve 7 between the upstream and downstream supports. The clasp 830 is configured to grip a portion of the valve leaflet between the upstream support 832 and the downstream support 834 by transitioning from the open state to the gripping state while the portion of the valve leaflet is positioned between the upstream and downstream supports. In the gripping state, the upstream support 832 and the downstream support 834 can be closer to each other than in the open state. In some applications, in the gripping state, if there is no obstruction (e.g., a portion of the valve leaflet), the upstream support 832 and the downstream support 834 are in contact with each other, for example, by pushing against each other.

[0656] The driver 850 is configured to fix the patch 610 to the valve leaflet by pushing the patch anchor 640 through the leaflet (for example, to fix it to a portion of the valve leaflet gripped between the upstream support 832 and the downstream support 834). The patch anchor 640 and the driver 850 can be configured in various ways, some of which are described below herein. Figures 31A to 35B show a configuration in which (i) the patch anchor 640 is a toggle anchor having a sharp tip, and (ii) the driver 850 is configured to push the patch anchor through the valve leaflet by pushing the lower end of the patch anchor distally while the patch anchor is substantially collinear with the driver and / or the pressing vector, for example, without locating the patch anchor within a needle. However, the scope of this disclosure includes by analogy to examples in which a needle is employed (e.g., a modification of system 500), as described with reference to Figures 20A to 25F.

[0657] In some applications, the tool 800 includes a capsule 870 at the distal end of the shaft 810. The capsule 870 is configured to house the downstream assembly 700 of the implant 550 during implant delivery and implantation. In some applications, the capsule 870 is sized to conceal the tissue engagement element 712 to reduce the possibility of the tissue engagement element inadvertently engaging with and / or damaging tissue while the distal portion 804 of the tool 800 is advancing tubewise.

[0658] The capsule 870 has an opening distal end 871 through which the downstream assembly 700 can be deployed. In an application where the winch 720 (e.g., its housing 721) has a lateral opening 726 through which the tether 560 passes, the capsule 870 may define the lateral window 874 so that the tether can reach the winch by housing the capsule in an orientation such that the lateral window 874 aligns with the opening 726.

[0659] The capsule 870 may be a single element, or it may comprise a housing 872 and a shroud 876, as shown. The shroud 876 may cover the distal portion of the housing 872 and may extend distally beyond the housing to form a rim 877. The shroud 876 may be formed from a material that is more flexible and / or more flexible than that of the housing 872 to reduce the likelihood of tissue damage (for example, the shroud may comprise an elastic material such as polymer or silicon). Thus, in applications where the shroud 876 extends distally beyond the housing to form a rim 877, the rim may function as a non-traumatic tip, which can be particularly advantageous when positioning the capsule 870 against the ventricular tissue while pressing the tissue engagement element 712 of the anchor 710 into the ventricular tissue.

[0660] In some applications where the capsule 870 comprises a housing 872 and a shroud 876, the housing may define an elongated lateral opening 875 extending proximal to the distal opening of the housing, for example, an elongated lateral opening 875 that is open to the distal opening of the housing. In such applications, and as shown in the figure, the shroud 876 can substantially cover the distal region of the elongated lateral opening 875, and as a result, the window 874 is defined proximal to the region of the elongated lateral opening, i.e., proximal to the shroud. In some such applications, the shroud 876 defines a narrow slit 878 extending between the distal opening of the shroud (which may function as the open distal end 871 of the capsule 870) and the window 874. The slit 878 may be aligned with the elongated lateral opening 875.

[0661] The elongated lateral openings 875 and / or slits 878 can be substantially parallel to the axis ax1.

[0662] The narrow slit 878 is configured to allow the tether 560 to pass smoothly through its interior while the downstream assembly 700 is deployed from the capsule 870, but it is also assumed that it reduces the possibility of harmful interactions with tissue during the capsule's advance into the ventricle, such as accidental capture of chordae tendineae within the elongated lateral opening 875, compared to a similar capsule having only a longitudinal lateral opening 875.

[0663] The narrow slit 878 is narrower than the elongated lateral opening 875 and may be less than 1 mm wide. In some applications, the narrow slit 878 is configured to be closed when stationary, for example, with its sides touching each other, and to temporarily widen as the tether 560 passes between them while the capsule 870 is being deployed to the downstream assembly 700.

[0664] While the implant 550 is loaded onto the delivery tool 800, the upstream assembly 600 may be positioned proximal to the downstream assembly 700 and fixed along the side of the shaft 810. In some applications, the upstream assembly 600 may also be mounted on a mount 840 which may be positioned from the side of the shaft 810, as shown. In such applications, the mounting of this upstream assembly 600 may be such that the patch 610 is pressed against the surface of the mount 840. In some such applications, the mount 840 may have a convex outer surface (for example, the mount may be a curved semicircle that is partially substantially arc-shaped around the shaft 810, and the patch 610 may be curved and spread along the convex outer surface of the mount, for example, as shown). In some applications, the patch 610 is thus held against the mount 840 by one or more wraps 842 wrapped around the patch and the mount. In some such applications, as illustrated, the wrap 842 also holds the patch 610 to the axis by wrapping around the shaft 810. As will be described in more detail below, the mount 840 is configured to carry the patch 610 toward the clasp 830.

[0665] In some applications, as shown (for example, in inset B of Figure 31B), each wrap 842 comprises (i) a pair of longitudinal portions 842L extending around the patch, and (ii) a flexible loop (e.g., a closed loop) which itself loops around the patch 610 to form two curved portions 842B, each curved portion connecting one end of the pair of longitudinal portions to the end of the other longitudinal portion of the pair. For each wrap 842, one of the curved portions is fixed to a bracket 844, and a rod 846 extends through the other curved portion to hold the looped wrap around the patch. The bracket 844 is spring-loaded, allowing the wrap 842 to be attached. In some applications, the orientation in which the wraps 842 and bracket 844 are positioned is also alternating, as shown, so that the rod 846 is held in place. To release the wrap 842 (for example, to release the patch 610 from being held against the mount 840 by the wrap), the rod 846 is retracted. This will be described in relation to the implantation of implant 550, with reference to Figure 32I.

[0666] As illustrated, the tether 560 can be attached to the lip region of the patch 610, for example, to the lip 611 of the patch, or in close proximity to the lip 611 of the patch (e.g., fixedly attached). As will be described in more detail below, the lip 611 is the edge of the patch that is located furthest from the root of the valve leaflet to which the patch will be fixed after implantation. For example, the lip 611 may be close to the lip of the valve leaflet to which the patch will be fixed, or it may extend beyond the lip of the valve leaflet (e.g., it may be located in the ventricle downstream of the valve being treated). The patch 610 can also be thought of to have a root region, for example, of the root edge 612 of the patch, or in close proximity to the root edge 612 of the patch. The root edge 612 is the edge of the patch opposite the lip 611 and is located in close proximity to the root of the valve leaflet to which the patch will be fixed after implantation, as will be described in more detail below. The patch 610 may also have two lateral edges 613a and 613b on the opposite side of the patch, extending between the lip 611 and the root lateral edge 612.

[0667] In some applications, as also shown, patch 610 is wider toward lip 611 (e.g., at lip 611) than toward root lateral edge 612 (e.g., at root lateral edge 612) (e.g., the distance between lateral edges 613a and 613b is greater). For example, patch 610 may approximate the shape of a trapezoid (e.g., an isotrapezoid), with lip 611 being the longer side of the trapezoid and root 612 being the shorter side of the trapezoid.

[0668] While the implant 550 is loaded onto the delivery tool 800, the patch 610 can be oriented such that the lip 611 is proximal to the root 612, for example, as shown. In this orientation, in applications where the tether 560 is attached to the marginal region of the patch 610, the tether may extend beyond the root lateral margin 612 along the patch to the lip region. For example, as also shown, a portion 561 of the tether 560 may extend along the patch on the side of the patch facing the shaft 810 (e.g., the concave side of the patch). In applications where the delivery tool 800 includes a mount 840, the portion 561 of the tether 560 may be positioned between the match and the mount (e.g., sandwiched), for example, as shown in Figure 31B.

[0669] In some applications, instead of, or in addition to, examples where the patch 610 is held against the surface of the mount 840 (e.g., by a wrap 842), the patch may be secured to the mount by a patch anchor 640. For example, the mount 840 may be molded to accommodate (or have one or more components configured to engage with) the patch anchor 640. In the illustrated example, the mount 840 is molded to define a groove 848 molded to receive the patch anchor 640 (e.g., one groove per patch anchor). As shown, the groove 848 may be defined on the side / convex surface of the mount 840, i.e., the surface on which the patch 610 is typically disposed. The groove 848 may be molded to allow the patch anchor 640 to slide along the groove, but to prevent the patch anchor from moving laterally out of the groove. Thus, in applications where the implant 550 provides a patch anchor 640 coupled to the patch 610, the patch is secured to the mount 840 by providing the patch anchor 640 within the groove 848. This relationship will be explained below with reference to Figures 32I to 32K.

[0670] In some applications where the implant 550 provides patch anchors 640 coupled to patch 610, this coupling is provided by codes 642, for example, each patch anchor is coupled to the patch by its respective code. In some such applications where the patch anchors 640 are positioned in grooves 848 and the grooves are shaped to prevent the patch anchors from protruding laterally from the groove, each code 642 secures the patch 610 to the mount 840 by extending to patch 610 in a direction away from the patch anchor and outward from the groove. This can be seen in Figure 32I. This can be done smoothly by making each groove 848 narrower at the surface of the mount than deep within the mount. For example, each groove 848 may have a substantially circular cross-sectional shape, with a portion of it open at the surface of the mount, as shown.

[0671]

[0002] In some applications, and as shown in the figures, the patch anchor 640 may be provided with a retrieval eyelet portion 641 to which a retrieval thread (not shown) can be releasably attached. The retrieval thread, and its use, can be applied mutatis mutandis as described for the tension member 388 of the system 270 and / or as described for the retrieval thread 908.

[0672] In some applications, the delivery tool 800 is configured such that the mount 840 is movable between a retracted position and a ready position. Figure 31B shows the mount 840 in the retracted position, which is also typically the position of the mount while the distal portion 804 of the tool 800 is advancing transductally, as shown, for example, in Figure 32A. In the ready position (Figure 32J), the mount 840 is closer to the clasp 830 than in the retracted position and may be in contact with the clasp (for example, with its upstream support 832). As will be described in more detail below, the driver 850 may be configured to screw the patch anchor 640 through the valve leaflet while the mount is in the ready position, as shown, for example, in Figure 32K.

[0673] In applications where wrap 842 is used, the wrap can hold patch 610 against mount 840 while the mount is in its retracted position. In some applications, as shown in Figure 32I, wrap 842 is released before mount 840 moves to its ready position.

[0674] In some applications, the groove 848 is substantially parallel to the axis ax1, as shown in Figure 32B with the tool 800 loaded.

[0675] In some applications where the patch anchor 640 is positioned within the groove 848, the driver 850 is configured to secure the patch to the valve leaflet (described below) by pushing the patch anchor outward from the distal end of the groove. In some of these applications, the driver 850 enters the groove via the proximal end of the groove. In some applications, the delivery tool 800 is provided with the distal end of the driver 850 (e.g., the driver head) already positioned within the groove 848. In some applications, the driver 850 simply contacts the patch anchor 640, while in other applications, the driver head is configured to engage and / or grip the anchor (e.g., the driver head and / or anchor have features that facilitate engagement and / or gripping of the anchor by the driver head).

[0676] As described above in this specification, the delivery tool 800 comprises at least one driver 850. In the illustrated example, the tool 800 comprises patch anchors 640, one driver 850 per anchor, for example, two drivers.

[0677] The extracorporeal proximal portion 802 may comprise one or more controllers. The representation of these controllers in Figure 31A is purely schematic, and each of these controllers may comprise knobs, wheels, levers, sliders, or other control elements or interfaces through which an operator (e.g., a physician) can operate the tool 800 to deliver and implant the implant 550, for example, using the techniques described herein.

[0678] In some applications, the proximal portion 802 includes a clasp controller 510 which is operablely coupled to the clasp 830 (e.g., to its upstream support 832), so that by operating the clasp controller, the clasp transitions between its open and gripped states (e.g., closed states). This operable coupling may be provided by a wire 530 coupled to the upstream support 832. In the illustrated example, two wires (e.g., parallel to each other) are used, but as illustrated, they can be formed from a single length wire that loops through the upstream support 832 and returns itself. The operation of pulling the wire 530 on the clasp controller 510 transitions the clasp 830 between its open and gripped states by moving (e.g., deflecting) the upstream support 832 relative to the upstream support 834 and typically the shaft 810.

[0679] In some applications, the proximal portion 802 includes a driver controller 512 operably coupled to the driver 850, and as a result, by operating the driver controller, the driver is guided to screw the patch anchors 640 into the valve leaflets to which the upstream assembly 600 is fixed. In the illustrated example, by operating the driver controller 512, the driver 850 is pushed distally, and as a result, each driver pushes the lower end of its respective patch anchor 640 distally.

[0680] The proximal portion 802 may include a mount controller 516 operably coupled to a mount controller 840, so that operation of the mount controller moves the mount between its retracted position and its ready position. This operable coupling can be provided by one or more mount control rods 536, the distal ends of which can be fixed to the mount 840. In some applications, the mount control rods 536 extend through a dedicated auxiliary lumen 808. In some applications, each mount control rod 536 may be tubular, and the auxiliary lumen can be shared with other control components of the tool 800, for example, another control component extending through a tubular mount control rod. For example, as shown, the driver 850 may also extend through the mount control rod 536.

[0681] In some applications, within the distal portion 804, the shaft 810 has a proximal portion 810a and a distal portion 810b, which are axially slidable relative to each other, for example in an extendable arrangement, as shown in the figure. In some such applications, the proximal portion 802 includes a shaft controller 514 (e.g., a shaft extension device) operablely coupled to the shaft 810, so that the distal portion of the shaft can be reversibly extended distally from the proximal portion of the shaft by operating the shaft controller. Note that the distal portion 810b may extend proximally at least to the proximal portion 810a, but is nevertheless referred to as the distal portion because it extends further distally than the proximal portion.

[0682] It should be noted that the various controller functions of the proximal portion 802 may be separated into single-function controllers or combined into a multi-function controller.

[0683] The proximal portion 810a may be tubular and, for example, accommodates the distal portion 810b. The distal portion 810b may be tubular and, for example, accommodates one or more drive shafts that control the distal assembly 700, as described below.

[0684] In some applications, a clasp 830 (e.g., its downstream support 834) is coupled to a shaft 810 such that extension of the distal portion 810b from the proximal portion 810a distally moves (e.g., deflects) the downstream support 834 relative to the axis. For example, a delivery tool 800 may include one or more frame elements 836 coupled to a shaft 810 and cooperating with the shaft to define a mechanical coupling that moves (e.g., deflects) the downstream support 834 relative to the shaft. In the illustrated example, a single frame element 836 pre-configured to bend or articulate in a special way (e.g., by the use of a flexion joint) provides this function. One end of the frame element is coupled to the proximal portion 810a of the shaft, and the other end of the frame element is coupled to the distal portion 810b of the shaft. Note that a similar effect can be achieved by using multiple frame elements that are articulate (e.g., hinged) with respect to each other.

[0685] In some applications, as illustrated, a single stock material piece also defines the upstream support 832, the downstream support 834, and the flex joint 833 that articulates the upstream support to the downstream support. In such applications, and as further illustrated, the downstream support 834 is fixed to a region 835 of the frame element 836. However, in other applications, the downstream support 834 may be defined simply by the region 835, and it should be understood that, for example, a single stock material may define the frame element 836 and the downstream support 834. In these other applications, the upstream support 832 may be formed from a separate material piece and articulately coupled to the downstream support 834.

[0686] In some applications, when the wire 530 is not under tension, moving the distal portion 810b axially relative to the proximal portion 810a causes both the downstream support 834 and the upstream support 832 to move (e.g., deflect) relative to the shaft 810. For example, the clasp 830 can be biased into its gripping state, and once the downstream support moves (e.g., deflects) relative to the shaft 810, it can remain in that state (e.g., the arrangement between the upstream support 832 and the downstream support 834 remains unchanged).

[0687] In some applications, as illustrated, the clasp 830 also defines one or more slots 837, and the driver 850 is configured to screw in patch anchors 640 through them (e.g., one slot per patch anchor). In some applications, it is a downstream support 834 that defines the slots 837 (whether it is part of a single stock material that also defines an upstream support 832, or defined by part of a frame element 836). That is, the downstream support 834 provides a counterforce while the patch anchor 640 is being pushed through the valve leaflet, and the patch anchor is positioned to pass through the downstream support in the slot 837, as will be described in more detail with reference to Figures 32K to 32L, for example. As a result, the code 642 passes through the slot 837, as will also be described in more detail later herein. While the cord 642 allows the cord to exit the slot 837 laterally, the clasp 830 (e.g., its downstream support 834) may define or include a slot guard 838 to prevent tissue (e.g., chordae tendineae) from entering the slot and becoming trapped. In some applications, the slot guard 838 is also elastic, as illustrated, and prevents cardiac tissue from entering the slot by covering the entrance to the slot, and is temporarily deflected away from the slot by the cord, so that the cord can exit the slot smoothly, as illustrated, for example, as described with reference to Figures 32L and 63. Examples of other slot guards that can be used are described with reference to Figures 64 and 65A–65B.

[0688] It should be noted that the scope of this disclosure includes (i) a delivery tool 800 comprising one or more needles similar to and / or generally corresponding to the needle 278 described herein, (ii) a patch anchor 640 not having a sharp tip, and (iii) a variant of the system 500 in which the patch anchor is not pushed directly through the valve leaflet, but rather the needle penetrates the valve leaflet and then the patch anchor advances outside the needle.

[0689] Herein, refer to Figures 32A–32Q, schematic diagrams illustrating at least some steps in a technique for treating a patient's heart valve 7 in some application examples. Although this technique is shown for use with System 500, in some application examples of System 500 (e.g., with a variant of the implant 550 and / or tool 800), and / or other systems can be used instead. In each of the frame Figures 32A–32P, the left-hand diagram shows the position and / or interaction of System 500 with respect to the heart, and the right-hand diagram highlights the state of the system itself.

[0690] With the implant 550 loaded on the distal portion 804 of the delivery tool 800, the distal portion is advanced transcatheterally to the subject's heart 4, for example, to the atrium 6 upstream of the valve 7. For example, as shown, the distal portion 804 can also be advanced transcatheterally and transseptally to the left atrium of the heart (Figure 32A).

[0691] In the illustrated example, the transcatheter advancement of the tool 800 is facilitated by one or more catheters 502, 504, one or more of which may be steerable (i.e., actively, for example, using pull wires or other components known in the art). For example, catheter 502 and / or catheter 504 may advance into the atrium, after which the tool 800 may advance through the catheter(s). In the illustrated example, the tool 800 is advanced transcatheter while in the delivery state.

[0692] In the delivery state, the patch 610 is held against the mount 840 and / or shaft 810 by the wrap 842, which may, for example, facilitate smooth forward movement and / or protect the patch. In some applications, as illustrated, the clasp 830 is also in a thin state in the delivery state. In such applications, the thin clasp 830 is typically closed (i.e., in its gripping state) but deflected distally (i.e., the clasp faces distally, and both the upstream support 832 and the downstream support 834 are deflected distally), so that, for example, the downstream support 834 is positioned adjacent to the shaft 810 (e.g., its distal portion 810b) and substantially parallel to it. As described herein, this is achieved by extending the distal portion 810b of the shaft 810 from the proximal portion 810a (i.e., extending the shaft telescopically) to straighten the frame element 836. In some applications, when the device is thin, the clasp 830 can be excessively opened, for example, by extending the distal portion 810b while applying tension to the wire 530, so that the upstream support 832 is substantially collinear with the downstream support 834.

[0693] While a thin configuration is advantageous for transcatheter advancement, in some cases the relatively large length of the distal portion 804 can be disadvantageous for intracardiac manipulation. Therefore, in some applications, once the distal portion 804 is positioned in the atrium 6 (e.g., the entire portion is positioned), the distal portion 804 is moved into a contracted state by, for example, operating the shaft controller 514 (Figure 32B), drawing the distal portion 810b of the shaft 810 into the proximal portion 810a (i.e., retracting the shaft). The clasp 830 is also typically closed when the distal portion 804 is in a contracted state, but is deflected proximally (i.e., the clasp faces proximally). Therefore, although the widest part of the distal portion 804 in a contracted state (at the level of the clasp 830) is wider than the widest part in a thin configuration, a shorter length of the distal portion is advantageous because it makes it easier to create a smaller "circle of rotation" when the distal portion is steered within the heart.

[0694] Next, the distal portion 804 (for example, in its contracted state) is deflected toward the valve 7 (Figure 32C) and enters the ventricle 8 (Figure 32D) downstream of the valve through the valve. Note that in this position, the leaflets of the valve 7 may join with the distal portion 804. Subsequently, the clasp 830 transitions to an open state in which the upstream support 832 and the downstream support 834 are positioned apart from each other, and the clasp is configured to receive a portion of the valve leaflets between the upstream and downstream supports.

[0695] In some applications, this is carried out as the following separate steps: (i) with the clasp closed, deflect the entire clasp (e.g., downstream) so that the clasp (or at least its downstream support 834) is substantially perpendicular to the shaft 810 and therefore protrudes as far to the side as possible, for example by operating the shaft controller 514 (Figure 32E); and (ii) then, with the downstream support 834 stationary, deflect the upstream support 832 and operate the clasp controller 510 (Figure 32F) to move the clasp into the open state. However, it should be understood that the scope of this disclosure includes other methods for moving the clasp 830 into its open state within the ventricle 8, such as deflecting the downstream support 834 downstream while the upstream support 832 is fixed.

[0696] The deflection of clasp 830 in the transition between Figure 32E and Figure 32F indicates that the clasp is deflected by partially extending the distal portion 810b of shaft 810, thereby maintaining the capsule 870 substantially stationary relative to the anatomical structure and retracting patch 610 proximal / upstream relative to the anatomical structure. However, it should be understood that this deflection can also be achieved by substantially stationing patch 610 relative to the anatomical structure and advancing capsule 870 distally / deeper into the ventricle.

[0697] While the clasp 830 remains open, the distal portion 804 is operated to move the clasp and receive a portion of the valve leaflet 10 (Figure 32G). For example, as shown, the distal portion 804 can also move proximal until the valve leaflet 10 settles on the downstream support 834. The portion of the valve leaflet 10 remains between the upstream support 832 and the downstream support 834, but the clasp closes (by transitioning toward its gripping state) to grip the portion of the valve leaflet (Figure 32H).

[0698] In applications where tool 800 includes a wrap 842, the wrap can be released at this stage if it has not been released previously. The insert in Figure 32H shows the wrap 842 securely holding patch 610 against mount 840 (not shown). As described above herein and as shown in Figure 32H, in some applications the wrap 842 may extend around shaft 810. In such applications, the wrap 842 should be released to facilitate subsequent processes in which patch 610, carried by mount 840, is moved away from shaft 810. Figure 32I shows the wrap 842 released by the retraction of rod 846 and patch 610 with the wrap released in response to the release of tension around shaft 810. Bracket 844 is shown as having changed shape in response to the release of tension on the wrap 842.

[0699] In some applications, the removal of such a wrap of patch 610 may be passive, for example, in response to the movement of blood following its release. In some applications, where patch 610 comprises a frame 630, the frame may be equipped with a spring or biased to open the pa...

Claims

1. A valve and device for use between the atria and ventricles of a subject's heart, wherein the valve has a first leaflet and a second leaflet, and the device comprises an implant, the implant being, Regardless of which of the valve leaflet dilation patches (610, 610a, 610b, 610c, 610d, 610e, 610f, 610g, 610h, 610i, 610j, 610k) is used, Flexible sheet (620) and A valve leaflet enlargement patch comprising: a frame (630) that supports the flexible sheet and defines springs (634, 650, 652, 654, 658, 660, 666, 668, 670, 672, 674); Patch anchors (640, 640a, 640b, 640c, 640d) are attached to the valve leaflet enlargement patch so as to fix the patch anchor to the first valve leaflet, thereby positioning the valve leaflet enlargement patch to join with the second valve leaflet during ventricular systole, A device comprising: a cord (642) through which the patch anchor is connected to the leaflet enlargement patch, the cord being connected to a spring, the spring being configured to tension the cord so as to pull the patch anchor toward the leaflet enlargement patch.

2. The implant comprises an upstream assembly having the leaflet enlargement patch and the patch anchor, The aforementioned implant, A downstream assembly comprising a winch coupled to a winch anchor configured to fix the downstream assembly to the tissue of the ventricle, The apparatus according to claim 1, further comprising a tether for connecting the winch to the valve leaflet enlargement patch.

3. The apparatus according to claim 1 or 2, wherein the spring is a compression spring.

4. The apparatus according to claim 1 or 2, wherein the spring is a cantilever spring.

5. The apparatus according to any one of claims 1 to 4, wherein the spring is substantially flat with respect to the valve leaflet expansion patch.

6. The apparatus according to any one of claims 1 to 4, wherein the spring extends outward from the plane defined by the valve leaflet expansion patch.

7. The apparatus according to any one of claims 1 to 6, wherein the spring extends beyond the flexible sheet of the valve leaflet expansion patch.

8. The apparatus according to any one of claims 1 to 7, wherein the patch anchor has a sharp tip and is configured to be pushed through the valve leaflet so that the sharp tip penetrates the valve leaflet.

9. The apparatus according to any one of claims 1 to 7, wherein the patch anchor is configured to be pushed through the valve leaflet while it is disposed within the hollow needle.

10. The apparatus according to any one of claims 1 to 9, wherein the spring is configured to push the patch anchor away from the valve leaflet expansion patch and through the valve leaflet, thereby temporarily deforming in response to the tension applied to the cord, and thereby enabling the patch anchor to be smoothly pushed through the valve leaflet.

11. The apparatus according to claim 10, wherein when the spring is temporarily deformed, the spring is coupled to the flexible sheet such that the valve leaflet expansion patch temporarily contracts linearly.

12. The apparatus according to claim 10, wherein when the spring is temporarily deformed, the spring is coupled to the flexible sheet so that the spring slides across the flexible sheet.

13. The aforementioned valve leaflet enlargement patch A lip, wherein the frame forms a lip brace, The base of the end of the valve leaflet expansion patch opposite to the lip, wherein the frame forms a base brace, and the spring is attached to the base brace, The apparatus according to claim 10, wherein the code connects the patch anchor to the valve leaflet enlargement patch by fixing the patch anchor to the first valve leaflet, thereby positioning the valve leaflet enlargement patch such that the lip of the valve leaflet enlargement patch extends toward the second valve leaflet.

14. The apparatus according to claim 13, wherein the spring is configured such that the temporary strain substantially results from temporarily compressing the spring between the lip brace and the root brace.

15. The apparatus according to claim 13, wherein the leaflet enlargement patch defines a root-to-lip axis between the lip and the root along the midline of the leaflet enlargement patch, and the spring is configured such that the temporary strain is substantially due to the deflection of the spring with respect to the root-to-lip axis.

16. The apparatus according to claim 15, wherein the spring is configured such that the temporary distortion substantially consists of a deflection of the spring toward the lip axis.

17. The apparatus according to claim 15, wherein the spring is a first spring, the frame further comprises a second spring, and the first spring and the second spring are configured such that the temporary strain is substantially due to the mutual deflection of the first spring and the second spring.

18. The apparatus according to claim 17, wherein the cord extends front to back between the first spring and the second spring.

19. The apparatus according to claim 13, wherein at least one of the frames defines a patch anchor support coupled to the root brace, and the cord extends from the spring to the patch anchor through the patch anchor support.

20. The apparatus according to claim 13, wherein the spring is configured such that the temporary distortion substantially consists of a temporary deflection of the spring relative to the root brace.

21. The apparatus according to claim 13, wherein the spring extends from the base brace to the lip brace.

22. The apparatus according to claim 21, wherein the spring extends along the midline of the valve leaflet expansion patch from the root brace to the lip brace.

23. The spring is a first spring that extends along the first lateral edge of the valve leaflet expansion patch from the root brace to the lip brace, The apparatus according to claim 21, wherein at least one of the frames defines a second spring extending from the root brace to the lip brace along a second lateral edge of the leaflet expansion patch.

24. The apparatus according to claim 13, wherein the spring does not extend to the lip brace.

25. The apparatus according to any one of claims 1 to 24, wherein the patch anchor comprises a toggle, the toggle defines a substantially intermediate eyelet along the toggle, and the cord is attached to the patch anchor at the eyelet.

26. The apparatus according to claim 25, further comprising a retrieval thread, which is coupled to the patch anchor at substantially the upper end of the toggle and configured to detach the patch anchor from the first valve leaflet when the retrieval thread is tensioned.

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