Heart valve treatment devices and delivery devices therefor

Abstract

Systems and methods for implanting medical devices are disclosed. In some implementations, a system and method for locking and unlocking clasp control members that control the clasps of an implantable medical device are provided. In some implementations, systems and methods for controlling the tension or stresses of one or more clasp actuator lines is provided. In some implementations, systems and methods for providing a catheter or lumen assembly for an implantable medical device are provided. In some implementations, clasp actuation lines are provided that are pre-stretched and / or are woven. In some implementations, the handle includes a clutch limits expansion and / or contraction of an expandable portion of a valve repair device. In some implementations, the handle includes an indicator that indicates a size of an expandable portion of a valve repair device. In some implementations, the handle includes an expansion portion that flexes to accommodate pressure spikes.

Description

Attorney Docket No: TMTTEER-14077W001HEART VALVE TREATMENT DEVICES AND DELIVERY DEVICES THEREFORCROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present application claims priority to US Provisional Patent Application No. 63 / 682,742 to Eltal et al., filed on August 13, 2024, and US Provisional Patent Application No. 63 / 769,981 to Eltal et al., filed on March 11, 2025, both of which are incorporated herein by reference in their entirety.BACKGROUND

[0002] The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves may be damaged, and thus rendered less effective, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such damage to the valves may result in serious cardiovascular compromise or death. Damaged valves can be surgically repaired or replaced during open heart surgery. However, open heart surgeries are highly invasive, and complications may occur. Transvascular techniques can be used to introduce and implant devices to treat a heart in a manner that is much less invasive than open heard surgery. As one example, a transvascular’ technique useable for accessing the native mitral and aortic valves is the trans-septal technique. The trans-septal technique comprises advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium). The septum is then punctured, and the catheter passed into the left atrium. A similar transvascular technique can be used to implant a device within the tricuspid valve that begins similarly to the trans-septal technique but stops short of puncturing the septum and instead turns the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the leftAttorney Docket No: TMTTEER-14077W001 ventricle. The mitral valve annulus may form a “D”-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet may be larger than the posterior leaflet, forming a generally “C”-shaped boundary between the abutting sides of the leaflets when they are closed together.

[0004] When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as “ventricular diastole” or “diastole”), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as “ventricular systole” or “systole”), the increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.

[0005] Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation may have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and thus the valve does not close, and regurgitation is present. Tricuspid regurgitation may be similar, but on the right side of the heart.Attorney Docket No: TMTTEER-14077W001SUMMARY

[0006] This summary is meant to provide some examples and is not intended to be limiting of 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 recite the feature. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

[0007] Devices for treating a native valve of a subject (e.g., a living subject, a simulation, etc.) arc disclosed. The devices can be valve treatment devices, valve repair devices, implantable devices, valve treatment devices, implants, etc. While sometimes described as an implantable device for illustration purposes in various examples herein, similar configurations can be used on other devices, e.g., valve treatment devices, valve repair devices, etc., that are not necessarily implanted and may be removed after treatment.

[0008] In some implementations, there is provided a valve treatment device, which can be an implantable device or implant (e.g., implantable device, etc.), that is configured to be positioned within a native heart valve to help the native heart valve to form a more effective seal. In some implementations, the valve treatment device is part of a valve treatment system including a delivery system having a catheter and a control handle wherein the valve treatment device is coupled to the delivery system.

[0009] In some implementations, a valve treatment device (such as an implantable device or implant) includes an anchor portion. Each anchor includes one or more of paddles that are moveable between an open position and a closed position.

[0010] In some implementations, a valve treatment device (e.g., an implantable device or implant) includes a coaptation element, a first anchor assembly configured to grasp a first leaflet of a native heart valve, and a second anchor assembly configured to grasp a second leaflet of the native heart valve.Attorney Docket No: TMTTEER-14077W001

[0011] In some implementations, the first anchor assembly is connected to a first side of the coaptation element, and the second anchor assembly is connected to a second side of an optional coaptation element.

[0012] Some implementations described herein relate to an apparatus and / or system (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) that includes a plurality of movable clasps. In some implementations, the apparatus and / or system includes first and second clasp control members. In some implementations, the apparatus and / or system includes a locking system.

[0013] In some implementations, the plurality of moveable clasps are configured to secure native leaflets of a heart valve. The first and second clasp control members arc coupled to the moveable clasps.

[0014] In some implementations, the locking system includes a channel. In some implementations, the locking system includes a first half ring and a second half ring. In some implementations, the first half ring and the second half ring are at least partially received in the channel. In some implementations, the first half ring is configured to engage and move the second half ring when the first half ring is moved between a locked position and an unlocked position. In some implementations, the second half ring is configured to engage and move the first half ring when the second half ring is moved between a locked position and an unlocked position.

[0015] In some implementations, a plurality of projections are disposed on the clasp control members. A plurality of recesses can be disposed on the first half ring and the second half ring for at least partially receiving at least one projection.

[0016] In some implementations, the channel comprises an arcuate shape.

[0017] In some implementations, the first half ring and the second half ring comprise an arcuate shapes.

[0018] In some implementations, the first half ring and the second half ring are configured to move within the channel.Attorney Docket No: TMTTEER-14077W001

[0019] In some implementations, the first and second clasp control members can move independently when the first half ring and the second half ring are in the unlocked positions.

[0020] In some implementations the first and second clasp control members move together when the first half ring and the second half ring are in the locked positions.

[0021] In some implementations the first half ring and the second half ring are configured to slide within the channel.

[0022] In some implementations the first half ring and the second half ring comprise a raised portion outside of the channel.

[0023] Some implementations described herein relate to an apparatus and / or system (which can be used with a valve of a heart, c.g., of a living subject or of a simulation) that includes a plurality of movable clasps. In some implementations, the plurality of movable clasps are configured to secure native leaflets of a heart valve.

[0024] In some implementations, the apparatus and / or system includes at least first a first clasp control member. In some implementations, the apparatus and / or system includes at least a second clasp control member. The at least first and / or second clasp control members are coupled to the movable clasps. For instance, the first clasp control member can be coupled to a first movable clasp of the plurality of movable clasps. The second clasp control member can be coupled to a second movable clasp of the plurality of movable clasps.

[0025] In some implementations, the first and / or second clasp control member includes a head portion and a rod portion connected to the head portion. In some implementations, the first and / or second clasp control member includes a chamber having a first section configured to allow movement of the head portion. In some implementations, the first and / or second clasp control member includes a second section configured to allow movement of the rod portion. In some implementations, the first and / or second clasp control member includes a biasing member disposed in the chamber between the head portion and the second section.

[0026] In some implementations, the biasing member at least partially encircles the rod portion. In some implementations, the biasing member is configured to compress between the headAttorney Docket No: TMTTEER-14077W001 portion and the second section of the chamber. In some implementations, the biasing member is configured to decompress between the head portion and the second section of the chamber.

[0027] In some implementations, the chamber rod portion is smaller than the chamber head portion.

[0028] In some implementations, the chamber head portion includes a first bearing surface and the chamber rod portion includes a second bearing surface. In some implementations, the biasing element is disposed in contact with the first and second bearing surfaces.

[0029] In some implementations, the system and / or apparatus further includes at least one clasp actuation line connecting the clasp control members to the movable clasps. For instance, at least one clasp actuation line can connect the first clasp control member to a first movable clasp. In some implementations, at least one clasp actuation line can connect a second claps control member to a second movable clasp.

[0030] In some implementations, the system and / or apparatus further includes at least one clasp actuation line connecting the chamber rod portion to the movable clasps.

[0031] In some implementations, the biasing member is configured to reduce tension generated on a clasp actuation line connected to at least one clasp control member.

[0032] In some implementations, the biasing member includes a spring pre-load between the head portion and the chamber second portion receiving the rod portion.

[0033] Some implementations described herein relate to a catheter apparatus and / or system for a medical device that includes a central tube. In some implementations, the catheter apparatus and / or system includes a first side tube. In some implementations, the catheter apparatus and / or system includes a second side tube. In some implementations, the central tube has a central tube body comprising a first coiled material. In some implementations, the first side tube has a first side tube body comprising a second coiled material. In some implementations, the second side tube has a second side tube body comprising a third coiled material.Attorney Docket No: TMTTEER-14077W001

[0034] In some implementations, the first coiled material, second coiled material and third coiled material are connected as single continuous coiled material.

[0035] In some implementations, the first, second and third coiled material comprises a metal material. In some implementations, the first, second and third coiled material comprises a stainless steel material. In some implementations, the first, second and third coiled material comprise one or more of a Nitinol material and a titanium material.

[0036] Some implementations described herein relate to a catheter apparatus and / or system for a medical device that includes an outer sheathing. The outer sheathing defines and inner space. In some implementations, the catheter apparatus and / or system includes a central tube. In some implementations, the central tube is disposed in the inner space. In some implementations, the catheter apparatus and / or system includes at least first and second side tubes. In some implementations, the at least first and second side tubes are disposed in the inner space.

[0037] In some implementations, the central tube has a central tube body including a first coiled material. In some implementations, the first side tube has a first side tube body including a second coiled material. In some implementations, the second side tube has a second side tube body including a third coiled material.

[0038] In some implementations, the first coiled material, second coiled material and third coiled material are connected as single continuous coiled material.

[0039] In some implementations, the catheter system further includes at least one spacer having a central portion for spacing the central tube and a plurality of outer portions for spacing the first and second side tubes.

[0040] In some implementations, the catheter system further includes one or more sensors disposed in the inner space. In some implementations, the one or more sensors can be disposed the first and second side tubes.

[0041] In some implementations, the first, second and third coiled material includes a metal material. In some implementations, the first, second and third coiled material includes a stainless steel material. In some implementations, the first, second and third coiled material includes aAttorney Docket No: TMTTEER-14077W001Nitinol material. In some implementations, the first, second and third coiled material includes a titanium material.

[0042] In some implementations, the outer sheath includes a fourth coiled material.

[0043] In some implementations, the outer sheath includes a cut pattern having a plurality of openings in the outer sheath.

[0044] In some implementations, the outer sheath includes a proximal section including a first metal material and a distal section including a second metal material, and wherein the first and second metal materials include different flexibilities.

[0045] In some implementations, a catheter system for a medical device includes an outer sheathing, a center tube, and at least first and second side tubes. The outer sheathing defines and inner space. The central tube and the at least first and second side tubes are disposed in the inner space. The central tube has a central tube body including a first coiled material. The first side tube has a first side tube body including a second coiled material. The second side tube has a second side tube body including a third coiled material.

[0046] In some implementations, a clasp actuation line for actuating a clasp of a valve repair device includes an elongated body extending between a first end and a second end. In some implementations, the clasp actuation line includes a closed loop formed in each of the first end and the second end.

[0047] In some implementations, the clasp of the valve repair device is actuated via a clasp control member and the clasp control member is operatively coupled to the elongated body of the clasp actuation line between the closed loops formed in the first end and the second end of the clasp actuation line.

[0048] In some implementations, the elongated body can comprise and / or be formed from a continuous line. In some implementations, the elongated body can be cut from the continuous line.Attorney Docket No: TMTTEER-14077W001

[0049] In some implementations, a pattern of bifurcated sections and unitary sections is formed in the continuous line. In some implementations, the pattern comprises two bifurcated sections separated by one unitary section.

[0050] In some implementations, the continuous line is cut between two adjacent bifurcated sections to form the clasp actuation line.

[0051] In some implementations, the continuous line is formed by braiding first braid yams and second braid yarns in a braid direction. In some implementations, the first braid yams and the second braid yarns are braided at a braid angle with respect to the braid direction.

[0052] In some implementations, the continuous line is stretched before the continuous line is cut to form the clasp actuation line and wherein the braid angle is reduced by the stretching.

[0053] In some implementations, the continuous line is routed around Godet rollers to be stretched.

[0054] In some implementations, the continuous line is heated to a temperature of 50 degrees Celsius to 100 degrees Celsius before the continuous line is cut to form the clasp actuation line.

[0055] In some implementations, the continuous line is formed by weaving warp yams and weft yams in a weaving direction, and wherein the warp yarns are aligned with the weaving direction.

[0056] In some implementations, the warp yarns and the weft yarns are woven together in a plain weave pattern. In some implementations, the warp yams and the weft yarns are woven together in one of a twill weave pattern, a stain weave pattern, and a sateen weave pattern.

[0057] In some implementations, a tail between the closed loop and the end of the clasp actuation line is not more than 1 millimeter long.

[0058] In some implementations, the clasp actuation line does not stretch more than 0.28 percent of a total length of the clasp actuation line subjected to a 3 newton tensile force. In some implementations, the clasp actuation line does not stretch more than 0.18 percent of a total length of the clasp actuation line subjected to a 3 newton tensile force.Attorney Docket No: TMTTEER-14077W001

[0059] In some implementations, a method of forming a clasp actuation line for actuating a clasp of a valve repair device includes steps of braiding an elongated body. In some implementations, the method includes forming a closed loop in each of a first end and a second end of the elongated body. In some implementations, the method includes stretching the elongated body.

[0060] In some implementations, the elongated body is routed around Godet rollers to be stretched.

[0061] In some implementations, the method includes a further step of heating the elongated body during the step of stretching the elongated body.

[0062] In some implementations, the elongated body is heated to a temperature of 50 degrees Celsius to 100 degrees Celsius during the step of stretching the elongated body.

[0063] In some implementations, the step of braiding comprises braiding first braid yams and second braid yarns in a braid direction, wherein the first braid yams and the second braid yarns are braided at a braid angle with respect to the braid direction, and wherein the braid angle is reduced by the step of stretching the elongated body.

[0064] In some implementations, after the stretching of the elongated body the clasp actuation line does not stretch more than 0.28 percent of a total length of the clasp actuation line subjected to a 3-newton tensile force. In some implementations, after the stretching of the elongated body the clasp actuation line docs not stretch more than 0.18 percent of a total length of the clasp actuation line subjected to a 3-newton tensile force.

[0065] In some implementations, a method of forming a clasp actuation line for actuating a clasp of a valve repair device includes braiding a continuous line, wherein the continuous line comprises a plurality of bifurcated sections separated by unitary sections. In some implementations, the method includes stretching the continuous line. In some implementations, the method includes cutting the continuous line between adjacent bifurcated sections to form an elongated member.

[0066] In some implementations, the continuous line is routed around Godet rollers to be stretched.Attorney Docket No: TMTTEER-14077W001

[0067] In some implementations, the method includes a further step of heating the continuous line during the step of stretching the continuous line.

[0068] In some implementations, the continuous line is heated to a temperature of 50 degrees Celsius to 100 degrees Celsius during the step of stretching the continuous line.

[0069] In some implementations, the step of braiding comprises braiding first braid yams and second braid yarns in a braid direction, wherein the first braid yams and the second braid yarns are braided at a braid angle with respect to the braid direction, and wherein the braid angle is reduced by the step of stretching the elongated body.

[0070] In some implementations, the elongated body does not stretch more than 0.28 percent of a total length of the clasp actuation line subjected to a 3-newton tensile force. In some implementations, the elongated body does not stretch more than 0.18 percent of a total length of the clasp actuation line subjected to a 3-newton tensile force.

[0071] In some implementations, a method of forming a clasp actuation line for actuating a clasp of a valve repair device includes weaving an elongated body. In some implementations, the method includes forming a closed loop in each of a first end and a second end of the elongated body.

[0072] In some implementations, the continuous line is formed by weaving warp yams and weft yams in a weaving direction, and wherein the warp yarns arc aligned with the weaving direction.

[0073] In some implementations, the warp yarns and the weft yarns are woven together in a plain weave pattern. In some implementations, the warp yams and the weft yarns are woven together in one of a twill weave pattern, a stain weave pattern, and a sateen weave pattern.

[0074] In some implementations, a tail between the closed loop and the end of the clasp actuation line is not more than 1 millimeter long.

[0075] In some implementations, a method of forming a clasp actuation line for actuating a clasp of a valve repair device includes weaving a continuous line, wherein the continuous line comprises a plurality of bifurcated sections separated by unitary sections. In someAttorney Docket No: TMTTEER-14077W001 implementations, the method includes cutting the continuous line between adjacent bifurcated sections to form an elongated member.

[0076] In some implementations, the continuous line is formed by weaving warp yams and weft yams in a weaving direction, and wherein the warp yarns are aligned with the weaving direction.

[0077] In some implementations, the warp yarns and the weft yarns are woven together in a plain weave pattern. In some implementations, the warp yarns and the weft yarns are woven together in one of a twill weave pattern, a stain weave pattern, and a sateen weave pattern.

[0078] In some implementations, a tail between the closed loop and the end of the clasp actuation line is not more than 1 millimeter long.

[0079] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes control handle of a delivery system. The delivery system can be configured to deliver a valve repair device into a heart of a subject.

[0080] In some implementations, the valve repair device can include a plurality of paddles movable between an open position and a closed position. The plurality of paddles can be used to attach the valve repair device to a native heart valve. The plurality of paddles can have a width that is adjustable between a first width and a second width.

[0081] In some implementations, the control handle can include a retractor. The retractor can be configured for moving a paddle width adjustment element. The paddle width adjustment element can be used to change the width of the plurality of paddles of the valve repair device.

[0082] In some implementations the control handle can include a paddle width control element. The paddle width control element can be used for moving the retractor in a proximal direction and / or a distal direction. In some implementations the control handle can include a clutch. The clutch can be used to restricts movement of the retractor when an actuation force applied to the paddle width control element exceeds a predetermined limit.

[0083] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes a valve repair deviceAttorney Docket No: TMTTEER-14077W001 for attaching to a native heart valve. In some implementations, system and / or apparatus includes a delivery system for delivering the valve repair device into a heart of a subject.[00841 In some implementations, the valve repair device includes a plurality of paddles that can be moved between an open position and a closed position. In some implementations, the plurality of paddles have a width that is adjusted between a first width and a second width.

[0085] In some implementations, the delivery system includes a control handle that includes a retractor for moving a paddle width adjustment element to change the width of the plurality of paddles of the valve repair device. In some implementations, the delivery system includes a paddle width control element that moves the retractor. For example, the paddle width control element can be actuated to move the retractor in a proximal direction and / or a distal direction.

[0086] In some implementations, the delivery system includes a clutch that prohibits movement of the retractor. For instance, the retractor can be prohibited from moving in the proximal direction or the distal direction when an actuation force applied to the paddle width control element exceeds a predetermined limit.

[0087] In some implementations, the paddle width control element includes a knob. In some implementations the knob can be used for applying a torque to an internally threaded drive tube that engages an externally threaded drive head of the retractor. Application of torque via the knob can cause the retractor to move, e.g., in the proximal direction and / or the distal direction.

[0088] In some implementations, the clutch includes a plurality of detents. The detents are configured for engaging a plurality of corresponding grooves in the internally threaded drive tube. The detents can be biased into the grooves by biasing members.

[0089] In some implementations, the detents are moved out of the grooves when an actuation force exceeds the predetermined threshold.

[0090] In some implementations, the biasing members include a plurality of arms extending radially inward from an annular body of the clutch. In some implementations, the plurality of arms extend radially inward in a spiral pattern. In some implementations, the plurality of arms are formed as flat springs.Attorney Docket No: TMTTEER-14077W001

[0091] In some implementations, the clutch is formed by additive manufacturing. In some implementations, the clutch is cut from a sheet of material.

[0092] In some implementations, the detents include ball detents. The ball detents can be disposed in radially extending channels of an annular body of the clutch. In some implementations, openings of the channels have a diameter that is less than a diameter of the ball detents. In some implementations, the biasing members include springs extending from the ball detents to an outer housing that surrounds the annular body.

[0093] In some implementations, the retractor includes a release knob. The release knob can rotate the paddle width adjustment element to release the paddle width adjustment element from the valve repair device.

[0094] In some implementations, a position indicator is attached to the release knob.

[0095] In some implementations, a cover for covering the release knob is attached to the retractor. In some implementations, the cover is rotatably attached to the retractor. In some implementations, the cover includes an indicator window to provide visibility as to the position of the position indicator.

[0096] In some implementations, the indicator window tapers in the proximal direction. In some implementations, the indicator window has a distal end that is wider than a proximal end.

[0097] In some implementations, a visible portion of the position indicator that is visible through the indicator window is largest when the retractor is in a maximum distal position. In some implementations, a visible portion of the position indicator that is visible through the indicator window is smallest when the retractor is in a maximum proximal position. In some implementations, the position indicator is formed with a contrasting color.

[0098] In some implementations, the cover is attached to the retractor via a friction ring. In some implementations, the friction ring is an O-ring. In some implementations, the friction ring is attached to the retractor via an annular carrier to enable the rotation of the cover relative to the retractor.

[0099] In some implementations, the valve repair device includes a clasp attached to each of the paddles. In some implementations, the delivery system includes a fluid body housing enclosingAttorney Docket No: TMTTEER-14077W001 an interior space. In some implementations, the delivery system includes a clasp control element for moving a clasp actuation line to cause the clasps to open and close. roiooi In some implementations, the delivery system includes a line-engaging member that is attached to and moved by the clasp control element through an orifice of the fluid body housing into the interior space. In some implementations, the delivery system includes an expansion portion of the fluid body housing.

[0101] In some implementations, the expansion portion can comprise and / or be formed from an elastic material. In some implementations, the expansion portion is disposed in an opening of the fluid body housing. In some implementations, the expansion portion comprises a silicone grommet.

[0102] In some implementations, the expansion portion is integrally formed with the fluid body housing. In some implementations, the expansion portion is attached to the fluid body housing via over molding.

[0103] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes control handle of a delivery system. The delivery system can be configured to deliver a valve repair device into a heart of a subject.

[0104] In some implementations, the valve repair device can include a plurality of paddles movable between an open position and a closed position. The plurality of paddles can be used to attach the valve repair device to a native heart valve. The plurality of paddles can have a width that is adjustable between a first width and a second width. In some implementations, the valve repair device can include a spacer. The spacer can have an adjustable width, such that a width of the spacer is adjustable between a first width and a second width.

[0105] In some implementations, the control handle can include a retractor. The retractor can be configured for moving a spacer width adjustment element. The spacer width adjustment element can be used to change the width of the spacer.

[0106] In some implementations the control handle can include a spacer width control element. The spacer width control element can be used for moving the retractor in a proximal direction and / or a distal direction.Attorney Docket No: TMTTEER-14077W001

[0107] In some implementations the control handle can include a clutch. The clutch can be used to restricts movement of the retractor when an actuation force applied to the spacer width control element exceeds a predetermined limit.

[0108] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes a valve repair device. In some implementations, the system and / or apparatus includes a control handle.

[0109] In some implementations, the valve repair device is configured for attaching to a native heart valve. In some implementations, the valve repair device includes a plurality of paddles that can be moved between an open position and a closed position. In some implementations, the valve repair device includes a spacer disposed between the pair of paddles. In some implementations, the spacer has a width that is adjusted between a first width and a second width.

[0110] In some implementations, the control handle includes a retractor for moving a spacer width adjustment element to change the width of the spacer of the valve repair device. In some implementations, the control handle includes a spacer width control element that moves the retractor. For example, the spacer width control element can be actuated to move the retractor in a proximal direction and / or a distal direction.

[0111] In some implementations, the control handle includes a clutch that prohibits movement of the retractor. For instance, the retractor may be prohibited from moving in the proximal direction or the distal direction when an actuation force applied to the spacer width control element exceeds a predetermined limit.

[0112] In some implementations, the spacer width control element comprises a knob. In some implementations, the knob can be used for applying a torque to an internally threaded drive tube that engages an externally threaded drive head of the retractor. Application of torque via the knob cause the retractor to move, e.g., in the proximal direction and / or the distal direction.Attorney Docket No: TMTTEER-14077W001

[0113] In some implementations, the clutch comprises a plurality of detents. The detents are configured for engaging a plurality of corresponding grooves in the internally threaded drive tube. The detents can be biased into the grooves by biasing members.

[0114] In some implementations, the detents are moved out of the grooves when an actuation force exceeds the predetermined threshold.

[0115] In some implementations, the biasing members comprise a plurality of arms extending radially inward from an annular body of the clutch. In some implementations, the plurality of arms extend radially inward in a spiral pattern. In some implementations, the plurality of arms are formed as flat springs.

[0116] In some implementations, the clutch is formed by additive manufacturing. In some implementations, the clutch is cut from a sheet of material.

[0117] In some implementations, the detents include ball detents. The ball detents can be disposed in radially extending channels of an annular' body of the clutch. In some implementations, openings of the channels have a diameter that is less than a diameter of the ball detents. In some implementations, the biasing members include springs extending from the ball detents to an outer housing that surrounds the annular body.

[0118] In some implementations, the delivery system includes a release knob of the retractor. The release knob is configured for rotating a spacer width control element to release the spacer width control element from the valve repair device.

[0119] In some implementations, the delivery system includes a position indicator is attached to the release knob.

[0120] In some implementations, the delivery system includes a cover for covering the release knob. In some implementations, the cover is attached to the retractor. In some implementations, the cover is rotatably attached to the retractor.

[0121] In some implementations, the cover comprises an indicator window to provide visibility as to the position of the position indicator. In some implementations, the indicator windowAttorney Docket No: TMTTEER-14077W001 tapers in the proximal direction. In some implementations, the indicator window has a distal end that is wider than a proximal end.

[0122] In some implementations, a visible portion of the position indicator that is visible through the indicator window is largest when the retractor is in a maximum distal position. In some implementations, a visible portion of the position indicator that is visible through the indicator window is smallest when the retractor is in a maximum proximal position. In some implementations, the position indicator is formed with a contrasting color.

[0123] In some implementations, the cover is attached to the retractor via a friction ring. In some implementations, the friction ring is an O-ring. In some implementations, the friction ring is attached to the retractor via an annular carrier to enable the rotation of the cover relative to the retractor.

[0124] In some implementations, the valve repair device comprises a clasp attached to each of the paddles. In some implementations, the delivery system comprises a fluid body housing enclosing an interior space. In some implementations, the delivery system comprises a clasp control element for moving a clasp actuation line to cause the clasps to open and close. In some implementations, the delivery system comprises a line-engaging member that is attached to and moved by the clasp control element through an orifice of the fluid body housing into the interior space.

[0125] In some implementations, the delivery system comprises an expansion portion of the fluid body housing. In some implementations, the expansion portion can comprise and / or be formed from an elastic material.

[0126] In some implementations, the expansion portion is disposed in an opening of the fluid body housing. In some implementations, the expansion portion comprises a silicone grommet.

[0127] In some implementations, the expansion portion is integrally formed with the fluid body housing. In some implementations, the expansion portion is attached to the fluid body housing via over molding.Attorney Docket No: TMTTEER-I4077WO0I

[0128] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes a heart valve repair device. In some implementations, the system and / or apparatus includes a control handle.

[0129] In some implementations, the valve repair device can attach to a native heart valve. In some implementations, the valve repair device comprises a plurality of paddles that can be moved between an open position and a closed position. In some implementations, the plurality of paddles have a width that can be adjusted between a first width and a second width.

[0130] In some implementations, the control handle includes a retractor for moving a paddle width adjustment element. The paddle width adjustment element can be moved to change the width of the plurality of paddles of the valve repair device.

[0131] In some implementations, the control handle includes a paddle width control element. The paddle width control element can be used to move the retractor. For instance, the paddle width control element can be actuated to move the retractor in a proximal direction and / or a distal direction.

[0132] In some implementations, the control handle includes a release knob of the retractor. The release knob can be used for rotating a paddle control element. In some implementations, rotation of the paddle control element can release the paddle control element from the valve repair device.

[0133] In some implementations, the control handle includes a position indicator disposed on the release knob.

[0134] In some implementations, the control handle includes a cover for covering the release knob. The cover can be attached to the retractor. In some implementations, the cover is rotatably attached to the retractor.

[0135] In some implementations, the cover comprises an indicator window to provide visibility as to the position of the position indicator. In some implementations, the indicator window tapers in the proximal direction. In some implementations, the indicator window has a distal end that is wider than a proximal end.Attorney Docket No: TMTTEER-14077W001

[0136] In some implementations, a visible portion of the position indicator that is visible through the indicator window is largest when the retractor is in a maximum distal position. In some implementations, a visible portion of the position indicator that is visible through the indicator window is smallest when the retractor is in a maximum proximal position.

[0137] In some implementations, the cover is attached to the retractor via a friction ring. In some implementations, the friction ring is an O-ring. In some implementations, the friction ring is attached to the retractor via an annular carrier to enable the rotation of the cover relative to the retractor.

[0138] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, c.g., of a living subject or of a simulation) includes a valve repair device. In some implementations the system and / or apparatus includes a control handle.

[0139] In some implementations, the valve repair device comprises a pair of paddles that can be moved between an open position and a closed position and a spacer disposed between the pair of paddles. In some implementations, the spacer has a width that is adjusted between a first width and a second width.

[0140] In some implementations, the control handle is for delivering the valve repair device into a heart of a subject. In some implementations, the control handle includes a retractor for moving a spacer width adjustment element to change the width of the spacer of the valve repair device.

[0141] In some implementations, the control handle includes a spacer width control element. The spacer width control element can move the retractor. For example, the spacer width control element can be actuated to move the retractor in a proximal direction and / or a distal direction.

[0142] In some implementations, the control handle can include a release knob of the retractor. The release knob can be used for rotating a paddle control element. Rotating the paddle control element can release the paddle control element from the valve repair device.

[0143] In some implementations, the control handle includes a position indicator disposed on the release knob.Attorney Docket No: TMTTEER-14077W001

[0144] In some implementations, the control handle includes a cover for covering the release knob, where the cover is attached to the retractor. In some implementations, the cover is rotatably attached to the retractor.

[0145] In some implementations, the control handle includes the cover comprises an indicator window to provide visibility as to the position of the position indicator. In some implementations, the indicator window tapers in the proximal direction. In some implementations, the indicator has a distal end that is wider than a proximal end.

[0146] In some implementations, a visible portion of the position indicator that is visible through the indicator window is largest when the retractor is in a maximum distal position. In some implementations, a visible portion of the position indicator that is visible through the indicator window is smallest when the retractor is in a maximum proximal position.

[0147] In some implementations, the cover is attached to the retractor via a friction ring. In some implementations, the friction ring is an O-ring. In some implementations, the friction ring is attached to the retractor via an annular carrier to enable the rotation of the cover relative to the retractor.

[0148] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes a valve repair device. In some implementations the system and / or apparatus includes a control handle.

[0149] In some implementations, the valve repair device includes a plurality of paddles that can be moved between an open position and a closed position. In some implementations, the valve repair device includes a pair of movable clasp arms that are movable relative to the pair of paddles.

[0150] In some implementations, the control handle includes a fluid body housing enclosing an interior space. In some implementations, the control handle includes a clasp control element for moving a clasp actuation line to cause the clasps to open and close. In some implementations, the control handle includes a line-engaging member that is attached to and moved by the claspAttorney Docket No: TMTTEER-14077W001 control element through an orifice of the fluid body housing into the interior space. In some implementations, the control handle includes an expansion portion of the fluid body housing.

[0151] In some implementations, the expansion portion can comprise and / or be formed from an elastic material. In some implementations, the expansion portion is disposed in an opening of the fluid body housing. In some implementations, the expansion portion comprises a silicone grommet.

[0152] In some implementations, the expansion portion is integrally formed with the fluid body housing. In some implementations, the expansion portion is attached to the fluid body housing via over molding. In some implementations, the expansion portion is disposed in a flush port of the fluid body housing.

[0153] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes an implant catheter, a first movable clasp, a second movable clasp, a first clasp control member, a second clasp control member, a first releasable connection, and a second releasable connection.

[0154] In some implementations, the first movable clasp is configured to secure a first native heart valve leaflet. In some implementations, the second movable clasp configured to secure a second native heart valve leaflet.

[0155] In some implementations, the first clasp control member extends through the implant catheter and through a first clasp opening that is connected to the first clasp. In some implementations, the first clasp control member extends through a first clasp loop that is connected to the first clasp. In some implementations, the second clasp control member extends through the implant catheter and through a second clasp opening. In some implementations, the second clasp control member extends through a second clasp loop that is connected to the first clasp.

[0156] In some implementations, the first releasable connection is connected to and / or couplable to the first clasp control member. In some implementations, the second releasable connection is connected to and / or couplable to the second clasp control member.Attorney Docket No: TMTTEER-14077W001

[0157] In some implementations the first releasable connection and the second releasable connection are configured to release the clasp control members sequentially without pulling the first clasp control member and the second clasp control member through the implant catheter. That is, the first releasable connection and the second releasable connection are configured to sequentially decouple from the first clasp control member and the second clasp control member while a distal portion of the first clasp control member and a distal portion of the second clasp control member remain out the distal portion of the implant catheter (e.g., remain distal to the distal portion of the implant catheter).

[0158] In some implementations, the first releasable connection is a breakable connection. In some implementations, the first releasable connection is configured to break when the first clasp control member is pulled a predetermined distance. In some implementations, the first releasable connection is configured to break when a predetermined force is applied to the first clasp control member.

[0159] In some implementations, the system further comprises a pair of paddles and a paddle actuation element. In some implementations, movement of the paddle actuation element moves the pair of paddles between an open position and a closed position. In some implementations, the first releasable connection comprises a first loop disposed around the paddle actuation element. In some implementations, the second releasable connection comprises a second loop disposed around the paddle actuation element. In some implementations, the first loop is distal to the second loop.

[0160] In some implementations, retraction of the paddle actuation element allows the first loop to slide off of the paddle actuation element and additional retraction of the paddle actuation element allows the second loop to slide off of the paddle actuation element.

[0161] In some implementations, the first releasable connection comprises a first tube, a first slidable member disposed in the first tube, and a first actuation element configured to move the first slidable member in the tube.

[0162] In some implementations, the first clasp control member is coupled to the first tube when the first slidable member is in a distal position. In some implementations, the first clasp control member is released when the first actuation element moves the first slidable member distally in the tube.Attorney Docket No: TMTTEER-14077W001

[0163] In some implementations, the first releasable connection comprises a first lumen, a first plug movable against an opening of the first lumen, and a first actuation element configured to move the first plug relative to the first lumen.

[0164] In some implementations, the first clasp control member is coupled to the first lumen when the first plug is pulled against the opening of the first lumen.

[0165] In some implementations, the first clasp control member is released when the first actuation element is slackened to allow movement of the first plug away from the first lumen.

[0166] In some implementations, the first releasable connection comprises a first lumen, a first eye member movable into an opening of the first lumen, and a first actuation element configured to move the first eye member relative to the first lumen.

[0167] In some implementations, the first clasp control member is coupled to the first lumen when the first eye member is pulled into the opening of the first lumen.

[0168] In some implementations, the first clasp control member is released when the first actuation element moves the first eye member out of the first lumen.

[0169] In some implementations, the eye member is flexible. In some implementations, the eye member is rigid.

[0170] In some implementations, the first releasable connection is releasably connected to a sensor. The sensor can be a leaflet depth sensor. In some implementations, the sensor can detect bioimpedance indicative of the depth of the leaflet in the secured in the first movable clasp. In some implementations, the first releasable connection comprises a loop disposed around the sensor. In some implementations, the first releasable connection is released by expanding the loop and pulling the leaflet depth sensor through the loop. The sensor can be a leaflet depth sensor. In some implementations, the sensor can detect bioimpedance indicative of the depth of the leaflet in the secured in the first movable clasp.

[0171] In some implementations, the first releasable connection comprises a loop attached to the first clasp control member and disposed around a retractable release element. In some implementations, the release element comprises a wire, a tube, or a shaft.Attorney Docket No: TMTTEER-14077W001

[0172] In some implementations, the first clasp is coupled to a bushing and wherein the release element extends into the bushing. In some implementations, the first clasp control member is released by pulling the release element out of the bushing.

[0173] In some implementations, the system further comprises a pair of paddles and a paddle actuation element. In some implementations, movement of the paddle actuation element moves the pair of paddles between an open position and a closed position. In some implementations, the paddle actuation element comprises a narrow portion. In some implementations, the first releasable connection comprises a first ring disposed around the paddle actuation element. In some implementations, the first clasp control member is released by moving the narrow portion into alignment with the first ring.

[0174] In some implementations, the system further comprises a pair of paddles and a paddle actuation element. In some implementations, movement of the paddle actuation element moves the pair of paddles between an open position and a closed position. In some implementations, the paddle actuation element comprises tube and a narrow shaft extending through the tube. In some implementations, the first releasable connection comprises a first ring disposed around the paddle actuation element. In some implementations, the first clasp control member is released by retracting the tube to expose the narrow shaft in the first ring.

[0175] In some implementations, the first releasable connection comprises a loop attached to the first clasp control member. In some implementations, the first clasp control member is wrapped around a release element. In some implementations, the loop is disposed around a projection of the release element.

[0176] In some implementations, the release element comprises a wire, a tube, or a shaft.

[0177] In some implementations, the first clasp control member is released by rotating the release element to unwind the first clasp control member.

[0178] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes an implant catheter, a first paddle, a second paddle, and a paddle actuation element. In some implementations the system canAttorney Docket No: TMTTEER-14077W001 include a first movable clasp, a second movable clasp, a single clasp control member, and a single releasable connection.

[0179] In some implementations, the first movable clasp is coupled to the first paddle. In some implementations, the first movable clasp is configured to secure a first native heart valve leaflet. In some implementations, the second movable clasp is coupled to the second paddle. In some implementations, the second movable clasp is configured to secure a second native heart valve leaflet.

[0180] In some implementations, the single clasp control member extends through the implant catheter, through a first clasp opening or through a second clasp loop that is connected to the first clasp, and through a second clasp opening or through a second clasp loop that is connected to the first clasp. In some implementations, the single releasable connection is connected to the single clasp control member. In some implementations, the paddle actuation element is configured to move the pair of paddles between an open position and a closed position. In some implementations, the single releasable connection comprises a single loop disposed around the paddle actuation element.

[0181] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes an implant catheter, a first movable clasp, a second movable clasp, a first clasp control member, and a second clasp control member. In some implementations, the first movable clasp is configured to secure a first native heart valve leaflet. In some implementations, the second movable clasp is configured to secure a second native heart valve leaflet.

[0182] In some implementations, the first clasp control member extends through the implant catheter. In some implementations, the first clasp control member is configured to move the first movable clasp to an open position. In some implementations, the first clasp control member is configured to push the first movable clasp to an open position. In some implementations, the second clasp control member is configured to move the second movable clasp to an open position. In some implementations, the second clasp control member is configured to push the second movable clasp to an open position.

[0183] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes a catheter, an implant, a controlAttorney Docket No: TMTTEER-14077W001 handle, and a rotary travel limiter. In some implementations, the implant is valve repair device or a replacement valve. In some implementations, the implant is coupled to the catheter. In some implementations, the control handle is coupled to the catheter.

[0184] In some implementations, the control handle is configured to move one or more movable components of the implant. In some implementations, the rotary travel limiter is disposed in the control handle. In some implementations, the rotary travel limiter is configured to limit one or more of a flex of the catheter and movement of one or more of the one or more movable components of the valve repair device or the replacement valve.

[0185] In some implementations, the rotary travel limiter comprises a rotatable input, one or more female receptacles, a slidable male member, and a slotted drive member. In some implementations, the rotatable input rotates the slotted drive member. In some implementations, the slidable male member is slidably disposed in both the one or more female receptacles and the slotted drive member.

[0186] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes an implant catheter having a distal portion and a proximal portion, a first movable clasp, a second movable clasp, a first clasp control member, and a second clasp control member. In some implementations, the system includes a first releasable connection couplable to the first clasp control member and a second releasable connection couplable to the second clasp control member.

[0187] In some implementations the first clasp control member extends through the proximal portion and out the distal portion of the implant catheter. The first clasp control member can have a distal portion couplable to the first clasp. In some implementations, the second clasp control member extends through the proximal portion and out the distal portion of the implant catheter. The second clasp control member can have a distal portion couplable to the second clasp.

[0188] In some implementations, the first releasable connection and the second releasable connection are configured to sequentially decouple from the first clasp control member and the second clasp control member while the distal portion of the first clasp control member and the distal portion of the second clasp control member remain out the distal portion of the implant catheter.Attorney Docket No: TMTTEER-14077W001

[0189] In accordance with some applications, a system and / or an apparatus (which can be used with a valve of a heart, e.g., of a living subject or of a simulation) includes an implant catheter having a distal portion and a proximal portion, a first movable clasp, a second movable clasp, a first clasp control member, and a second clasp control member. In some implementations, the system includes a first releasable connection couplable to the first clasp control member and a second releasable connection couplable to the second clasp control member.

[0190] In some implementations the first clasp control member extends through the proximal portion and out the distal portion of the implant catheter. The first clasp control member can have a distal portion couplable to the first clasp. In some implementations, the second clasp control member extends through the proximal portion and out the distal portion of the implant catheter. The second clasp control member can have a distal portion couplable to the second clasp.

[0191] In some implementations, the system includes a first releasable connection couplable to the first clasp control member and a second releasable connection couplable to the second clasp control member. In some implementations, the first releasable connection and the second releasable connection are configured to sequentially decouple from the first clasp control member and the second clasp control member while the distal portion of the first clasp control member and the distal portion of the second clasp control member remain out the distal portion of the implant catheter.

[0192] In some implementations the system comprises a locking system. The locking system can comprise: a channel, a first half ring at least partially received in the channel, and a second half ring at least partially received in the channel. In some implementations, at least one of the first half ring and the second half ring can be moved between a locked and unlocked position. In some implementations, the first half ring and the second half ring are engaged and configured to move together while in the locked position.

[0193] In some implementations, each clasp control member comprises: a rod having a head portion and a rod portion, a chamber, and a biasing member. In some implementations, the chamber has a first section configured to allow movement of the head portion and a second section configured to allow movement of the rod portion. In some implementations the biasing member is disposed in the chamber between the head portion and the second section. In someAttorney Docket No: TMTTEER-14077W001 implementations, each clasp control member comprises a clasp actuation line extending from the rod portion toward a movable clasp.

[0194] In some implementations, the system comprises a catheter system. The catheter system can comprise a central tube, a first side tube, and a second side tube. In some implementations, the central tube has a central tube body comprising a first coiled material. In some implementations, the first side tube has a first side tube body comprising a second coiled material. In some implementations, the second side tube has a second side tube body comprising a third coiled material.

[0195] In some implementations, the system comprises a catheter system. The catheter system can comprise an outer sheath having an inner space, a central tube, a first side tube, and a second side tube. In some implementations, the first side tube and the second side tube are disposed in the inner space of the outer sheath. In some implementations, the central tube has a central tube body comprising a first coiled material. In some implementations, the first side tube has a first side tube body comprising a second coiled material. In some implementations, the second side tube has a second side tube body comprising a third coiled material.

[0196] In some implementations, the system comprises a clasp actuation line. The clasp actuation line can comprise an elongated body extending between a first end and a second end. The clasp actuation line can comprise a closed loop formed in each of the first end and the second end.

[0197] In some implementations, the system comprises a valve repair device and a control handle. The valve repair device can comprise the first movable clasp and the second movable clasp, and a plurality of paddles movable between an open position and a closed position. The plurality of paddles can have a width that is adjustable between a first width and a second width.

[0198] The control handle can be provided for implanting the valve repair device. The control handle can comprise a retractor and a paddle width control element. The retractor can move a paddle width adjustment element to change the width of the plurality of paddles of the valve repair device. The paddle width control element can move the retractor in a proximal direction and / or a distal direction. The control handle can also include a clutch that restricts movement of the retractor when an actuation force applied to the paddle width control element exceeds a predetermined limit.Attorney Docket No: TMTTEER-14077W001

[0199] In some implementations, the system comprises a valve repair device and a control handle. The valve repair device can comprise the first movable clasp and the second movable clasp, a plurality of paddles movable between an open position and a closed position, and a spacer. The spacer can be positioned between the paddles of the plurality of paddles. For instance, the spacer can be positioned between two or more paddles of the plurality of paddles.

[0200] The control handle can be provided for implanting the valve repair device. The control handle can comprise a retractor and a spacer width control element. The retractor can move a spacer width adjustment element to change the width of the spacer. The spacer width control element can move the retractor in a proximal direction and / or a distal direction. The control handle can also include a clutch that restricts movement of the retractor when an actuation force applied to the spacer width control element exceeds a predetermined limit.

[0201] In some implementations, the system comprises a delivery system. The delivery system can comprise a fluid body housing enclosing an interior space. The delivery system can comprise a first line-engaging member that is attached to and moved by the first clasp control member through an orifice of the fluid body housing into the interior space. In some implementations, the delivery system can comprise an expansion portion of the fluid body housing.

[0202] In some implementations, the system comprises the system comprises an implant. The implant (e.g., valve repair device or valve replacement device) and a control handle. The implant can comprise the first movable clasp and the second movable clasp. In some implementations, the implant can comprise a plurality of paddles movable between an open position and a closed position.

[0203] The control handle can be configured to move one or more movable components (e.g., the first and second movable clasp and / or a paddle of the plurality of paddles) of the implant. In some implementations, the control handle includes a rotary travel limiter disposed in the control handle. The rotary travel limiter is configured to limit one or more of a flex of the catheter and movement of one or more of the movable components of the implant.

[0204] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulatedAttorney Docket No: TMTTEER-14077W001 heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0205] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with subjects, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0206] A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.BRIEF DESCRIPTION OF THE DRAWINGS

[0207] To further clarify various aspects of examples in the present disclosure, a more particular description of certain examples and implementations will be made by reference to various aspects of the appended drawings. These drawings depict only example implementations of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0208] FIG. 1 illustrates a cutaway view of the human heart in a diastolic phase;

[0209] FIG. 2 illustrates a cutaway view of the human heart in a systolic phase;

[0210] FIG. 3 illustrates a cutaway view of the human heart in a systolic phase showing valve regurgitation;

[0211] FIG. 4 is the cutaway view of FIG. 3 annotated to illustrate a natural shape of mitral valve leaflets in the systolic phase;Attorney Docket No: TMTTEER-14077W001

[0212] FIG. 5 illustrates a healthy mitral valve with the leaflets closed as viewed from an atrial side of the mitral valve;

[0213] FIG. 6 illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve;

[0214] FIG. 7 illustrates a tricuspid valve viewed from an atrial side of the tricuspid valve;

[0215] FIGS. 8-14 show an example of a valve treatment device, in various stages of deployment;

[0216] FIG. 15 shows an example of a valve treatment device that is similar to the device illustrated by FIGS. 8-14, but where the paddles are independently controllable;

[0217] FIGS. 16-21 show the example device of FIGS. 8-14 being delivered and deployed within a native valve;

[0218] FIG. 22 shows a perspective view of an example device or implant in a closed position;

[0219] FIG. 23 shows a perspective view of an example device or implant in a closed position;

[0220] FIG. 24 illustrates an example valve treatment device with paddles in an open position;

[0221] FIG. 25A illustrates an example valve treatment device with paddles in a closed position;

[0222] FIG. 25B illustrates a top view of an example valve treatment device;

[0223] FIG. 26 illustrates a perspective view of an example device having paddles of adjustable widths;Attorney Docket No: TMTTEER-14077W001

[0224] FIG. 27 is a cross-section of the example device of FIG. 26 in which the device is bisected;

[0225] FIG. 28 is another cross-section of the device of FIG. 26 in which the device is bisected along a plane perpendicular to the plane illustrated in FIG. 28;

[0226] FIG. 29 is a schematic illustration of an example implant catheter assembly coupled to a valve treatment device in which an actuation element is coupled to a paddle actuation control and to a driver head of the device;

[0227] FIG. 30 is an illustration of the assembly of FIG. 29 with the device rotated 90 degrees to show the paddle width adjustment element coupled to an inner end of the connector of the device and coupled to a paddle width control;

[0228] FIG. 31 illustrates a distal end of an example delivery assembly including a delivery apparatus and a device.

[0229] FIG. 32 illustrates a proximal end of the example delivery assembly of FIG. 31.

[0230] FIG. 33 is an example catheter assembly that can be used in conjunction with the handles of any of the examples described herein.

[0231] FIG. 34 is a schematic illustration of an example catheter assembly coupled to a device, in which each of the clasp actuation lines is coupled to a clasp control member positioned on the handle and the actuation element is coupled to a knob positioned on the handle.

[0232] FIG. 35 is a perspective view of an example handle of a catheter assembly.

[0233] FIG. 36 is a cross-section of the handle of FIG. 35 perpendicular to the plane defined by line A — A, in which one of the clasp control tubes is bisected.

[0234] FIG. 37 is another cross-section of the handle of FIG. 35 perpendicular to the plane defined by line B — B, in which the release knob is bisected.

[0235] FIG. 38 is an enlarged portion of FIG. 37.Attorney Docket No: TMTTEER-14077W001

[0236] FIG. 39 is another cross-section of the handle of FIG. 35 perpendicular to the plane defined by line C — C, in which the release knob and the suture locks are bisected.

[0237] FIG. 40 is another perspective view of the handle of FIG. 35 in which the housing includes a pair of detents for fixing the clasp control members into position.

[0238] FIG. 41 is a partial cross-section view of the portion of the handle of FIG. 40 showing the clasp control members.

[0239] FIG. 42 is a cross-section view of the portion of the handle of FIG. 41.

[0240] FIG. 43 is a cross-section view of the portion of the handle of FIG. 41.

[0241] FIGS. 44, 45 and 46 illustrate one example of a clasp control member slider assembly.

[0242] FIGS. 47, 48 and 49 illustrate various views of one example of the unlocked position or state of a clasp control member slider assembly.

[0243] FIGS. 50 and 51 show perspective and front views of a clasp member slider assembly in the locked position or state.

[0244] FIGS. 52, 53, and 54 show views of an example of a lockable and unlockable clasp control member slider assembly.

[0245] FIG. 55 is a cross-section view of a portion of the handle showing the handle when an example device is an elongated or fully open condition.

[0246] FIG. 56 is a perspective view of the example device in an elongated or fully open condition.

[0247] FIG. 57 is a cross-section view of a portion of the handle showing the handle when the device is transitioning from the fully open condition to a fully closed position.

[0248] FIG. 58 is a perspective view of the device in a partially open position.Attorney Docket No: TMTTEER-14077W001

[0249] FIG. 59 is a perspective view of the device in a fully closed condition.

[0250] FIG. 60 is a cross-section view of a portion of the handle showing the handle when the paddles of the device are in an expanded position.

[0251] FIG. 61 is a perspective view of the device with the paddles in the expanded position.

[0252] FIG. 62 is a cross-section view of a portion of the handle showing the handle when the paddles of the device are in a narrowed position.

[0253] FIG. 63 is a perspective view of the device with the paddles in the narrowed position.

[0254] FIG. 64 is a schematic illustration of a device attached to a delivery system.

[0255] FIG. 65 illustrates an example of a device or implant shown in a partially open, graspready condition with the clasps in a fully open position.

[0256] FIG. 66 illustrates the device or implant of FIG. 65 with the clasps in a drooped position.

[0257] FIG. 67 illustrates an example of a device or implant shown in an elongated condition with the clasps in a fully open position.

[0258] FIG. 68 illustrates the device or implant of FIG. 67 with the clasps in a drooped position.

[0259] FIG. 69 is a schematic illustration of an example catheter assembly coupled to a device, in which each of the clasp actuation lines is coupled to a clasp control member that is biased to eliminate clasp droop.

[0260] FIG. 70 is a schematic illustration of an example catheter assembly coupled to a device, in which each of the clasp actuation lines includes an elastic portion.

[0261] FIG. 71 illustrates an example clasp actuation portion of a catheter assembly device in which example clasp control members are in a first position.

[0262] FIG. 72 illustrates an example clasp actuation portion of a catheter assembly device in which example clasp control members are in a second position.Attorney Docket No: TMTTEER-14077W001

[0263] FIG. 73 schematically illustrates a clasp line tensioning arrangement in a situation when a clasp is in a closed or initial delivery configuration.

[0264] FIG. 74 schematically illustrates the clasp line tensioning arrangement in a situation when a clasp has been moved from the closed to the open configuration and is, for example, leaflet capture ready.

[0265] FIG. 75 schematically illustrates the clasp line tensioning arrangement in a situation when the clasp has been moved to the open configuration, but some stretch has occurred in a clasp actuation line and / or delivery tubing or catheters.

[0266] FIGS. 76, 77, and 78 schematically illustrate one example of a system for slack or droop compensation.

[0267] FIGS. 79, 80, and 81 illustrate another example of a system for slack and droop compensation.

[0268] FIG. 82 is a perspective view of one example of a multi-lumen catheter system having lumens or tubes made from a coiled material.

[0269] FIG. 83 illustrates one example wherein the multiple tubes of FIG. 82 are within a catheter system having an outer sheathing or outer tube provided with a coupler.

[0270] FIG. 84 is a sectional view taken along section line C-C in FIG. 83.

[0271] FIG. 85 is a sectional view taken along section line D-D in FIG. 83.

[0272] FIG. 86 illustrates one example of the multi-lumen catheter system having a proximal section and distal section.

[0273] FIG. 87 illustrates one example of an interrupted spiral laser cut pattern.

[0274] FIG. 88 illustrates a partial perspective view of one example multi-lumen catheter system with portions of outer tube removed for clarity.Attorney Docket No: TMTTEER-14077W001

[0275] FIG. 89 illustrates an end view of one example of a multi-lumen catheter system having a four outer lumen configuration.

[0276] FIG. 90 illustrates an end view of one example of a multi-lumen catheter system having a two outer lumen configuration with lumen-like spaces therebetween.

[0277] FIG. 91 is a perspective view of a valve repair device in an elongated position illustrating an example of a capture mechanism and clasp control member routing.

[0278] FIG. 92 is a side view of an example clasp actuation line.

[0279] FIG. 93 is a schematic illustration of the device attached to the delivery system showing routing of the clasp actuation lines.

[0280] FIG. 94 is the schematic illustration of FIG. 93 where the device is decoupled from the delivery system.

[0281] FIGS . 95-97 are schematic illustrations of a valve repair device attached to the delivery system showing various stages of release of the valve repair device.

[0282] FIGS. 98-100 are perspective views of an example of a capture mechanism in various stages of release of a valve repair device.

[0283] FIGS. 101- 103 illustrate an example of a valve repair system configured to release clasp control lines from the clasps one at a time;

[0284] FIGS. 104-108 illustrate an example of a valve repair system configured to release clasp control lines from the clasps one at a time;

[0285] FIGS. 109- 111 illustrate an example of a valve repair system configured to release clasp control lines from the clasps one at a time;

[0286] FIGS. 112-113 illustrate an example of a valve repair system with a single clasp control line with a single loop coupled to a plurality of clasps;Attorney Docket No: TMTTEER-14077W001

[0287] FIGS. 114-117 illustrate an example a valve repair system configured to release clasp control lines from the clasps one at a time;

[0288] FIGS. 118-119 illustrate an example of components a valve repair system configured to release clasp control lines from the clasps one at a time;

[0289] FIGS. 120-121 illustrate an example of components a valve repair system configured to release clasp control lines from the clasps one at a time;

[0290] FIGS. 122-124 illustrate an example of components of a valve repair system having a sensor assemblies used to couple and decouple clasp controls elements from clasps of a valve repair device;

[0291] FIGS. 125-126 illustrate an example of components a valve repair system configured to release clasp control lines from the clasps one at a time;

[0292] FIG. 127 illustrates an example of components a valve repair system configured to release clasp control lines from the clasps one at a time;

[0293] FIGS. 128-131 illustrate an example of components a valve repair system configured to release clasp control lines from the clasps one at a time;

[0294] FIG. 130A illustrates an example of a bushing of a valve repair device;

[0295] FIGS. 132-133 illustrate an example of components a valve repair system configured to release clasp control lines from the clasps one at a time;

[0296] FIGS. 134-135 illustrate an example of components of a valve repair system configured to release clasp control lines from the clasps one at a time;

[0297] FIGS. 134-135 illustrate an example of components of a valve repair system configured to release clasp control lines from the clasps one at a time;

[0298] FIGS. 136-137 illustrate an example of components a valve repair system configured to release clasp control lines from the clasps one at a time;Attorney Docket No: TMTTEER-14077W001

[0299] FIGS. 138-139 illustrate an example of components a valve repair system configured to release clasp control lines from the clasps one at a time;

[0300] FIGS. 140-141 illustrate an example of components a valve repair system configured to release clasp control lines from the clasps one at a time;

[0301] FIGS. 142-143 illustrate an example of components of a valve repair system configured to release clasp control lines from the clasps one at a time;

[0302] FIGS. 144-145 illustrate an example of a valve repair system configured to independently push movable clasp arms of a valve repair device;

[0303] FIG. 146 is a side view of an example of a clasp actuation line.

[0304] FIG. 147 is a side view of an example of a clasp actuation line.

[0305] FIGS. 148-149 are side views of an example of a clasp actuation line.

[0306] FIGS. 150-151 are side views of an example of a clasp actuation line.

[0307] FIGS. 152-153 are side views of an example of a clasp actuation line.

[0308] FIGS. 154-155 are side views of an example of a clasp actuation line;

[0309] FIG. 156 is a side view of an example of a clasp actuation line;

[0310] FIG. 157 is an enlarged view of a braided material of an example of a clasp actuation line;

[0311] FIG. 158 is an enlarged view of the braided material of FIG. 157 after stretching;

[0312] FIGS. 159-160 are schematic illustrations of processes of stretching an example of a continuous braided line;

[0313] FIG. 161 is an enlarged view of a woven material of an example of a clasp actuation line;Attorney Docket No: TMTTEER-14077W001

[0314] FIG. 162 is a perspective view of an example of a control handle and its aesthetic features;

[0315] FIG. 163 is a side-view of the control handle;

[0316] FIG. 164 is a top cross-sectional view of a proximal portion of the control handle;

[0317] FIG. 165 is a side cross-sectional view of a proximal portion of the control handle;

[0318] FIG. 166 is an exploded view of the control handle from a bottom perspective viewpoint;

[0319] FIG. 167 is a top perspective view of the control handle;

[0320] FIG. 168 is a perspective view of a retractor assembly with the knob removed;

[0321] FIG. 169 is a perspective view of a clutch of the retractor assembly;

[0322] FIG. 170 is a front view of the clutch;

[0323] FIG. 171 is a perspective view of a retractor assembly;

[0324] FIG. 172 is a front view of a clutch of the retractor assembly;

[0325] FIG. 173 is an exploded view of the clutch;

[0326] FIG. 174 is a side view of a retractor assembly with a position indicator in a fully proximal condition;

[0327] FIG. 175 is a cross-sectional view of the retractor assembly;

[0328] FIG. 176 is a side view of the retractor assembly of FIG. 174 with a position indicator in a fully distal condition;

[0329] FIG. 177 is a cross-sectional view of the retractor assembly;Attorney Docket No: TMTTEER-14077W001

[0330] FIG. 178 is a top perspective view of the retractor assembly of FIG. 176 with a cover;

[0331] FIG. 179 is a perspective view of the retractor assembly with the retractor in the fully proximal condition;

[0332] FIG. 180 is an exploded view of the retractor assembly;

[0333] FIG. 181 is a bottom perspective view of the release knob of the retractor assembly;

[0334] FIG. 182 is an exploded view of an O-ring assembly of the retractor assembly;

[0335] FIG. 183 is a cross-sectional view of the control handle of FIG. 162 showing a distal portion of a clasp control section of the control handle and its aesthetic features;

[0336] FIG. 184 is a top perspective view of an example of a fluid body housing of the control handle;

[0337] FIG. 185 is a bottom perspective view of the fluid body housing;

[0338] FIG. 186 is an exploded view of the fluid body housing from a top perspective viewpoint;

[0339] FIG. 187 is a cross-sectional view of the fluid body housing taken through an actuation line port and a flushing port of the fluid body housing;

[0340] FIG. 188 is a cross-sectional view of the fluid body housing taken through an expansion portion of the fluid body housing;

[0341] FIGS. 189-192 illustrate an example of a rotational movement stop mechanism;

[0342] FIGS. 193-195 illustrate an example of a valve repair device delivery handle with a rotational input stop mechanism; and

[0343] FIG. 196 illustrates an example of a rotational movement stop mechanism;Attorney Docket No: TMTTEER-14077W001DETAILED DESCRIPTION

[0344] The following description refers to the accompanying drawings, which illustrate example implementations of the present disclosure. Other implementations having different structures and operation do not depart from the scope of the present disclosure.

[0345] Example implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing a defective heart valve. For example, various examples of valve treatment devices, valve repair devices, implantable devices, implants, and systems (including systems for delivery of the valve treatment devices, valve repair devices, implantable devices, and implants) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.

[0346] Further, the techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0347] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a "member," “component,” or “portion” shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms “substantially” and “about” areAttorney Docket No: TMTTEER-14077W001 defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of). The terms “clasp” and “clasp arm” are often used herein with respect to specific examples, but the terms “gripping member” and / or “gripper arm” can be used in place of and function in the same or similar ways, even if not configured in the same way as a typical clasp.

[0348] FIGS. 1 and 2 are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV, i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in FIGS. 3-6 and leaflets 30, 32, 34 shown in FIG. 7) extending inward across the respective orifices that come together or “coapf ’ in the flow stream to form the one-way, fluid-occluding surfaces. The native valve repair systems of the present application are frequently described and / or illustrated with respect to the mitral valve MV. Therefore, anatomical structures of the left atrium LA and left ventricle LV will be explained in greater detail. However, the devices described herein can also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0349] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in FIG. 1, the blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in FIG. 2, the left ventricle LV contracts to force the blood through the aortic valve AV and ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent the blood from regurgitating from the left ventricle LV and back into the left atrium LA and blood is collected in the left atrium from the pulmonary vein. In some implementations, the devices described by the present application are used to repair the function of a defective mitral valve MV. That is, the devices are configured to help close the leaflets of the mitral valve to prevent, inhibit or reduce blood from regurgitating from the left ventricle LV and back into the left atrium LA. Many of the devices described in the present application are designed to easily grasp and secure the nativeAttorney Docket No: TMTTEER-14077W001 leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant orifice to prevent or inhibit back flow or regurgitation during systole, though this is not necessary.

[0350] Referring now to FIGS. 1-7, the mitral valve MV includes two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see Fig. 5), which is a variably dense fibrous ring of tissues that encircles the leaflets 20, 22. Referring to FIGS. 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., the muscles located at the base of the chordae tendineae CT and within the walls of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM serve to limit the movements of leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from being reverted. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressure needed to circulate blood throughout the body. Together the papillary muscles PM and the chordae tendineae CT arc known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As seen from a Left Ventricular Outflow Tract (LVOT) view shown in FIG. 3, the anatomy of the leaflets 20, 22 is such that the inner sides of the leaflets coapt at the free end portions and the leaflets 20, 22 start receding or spreading apart from each other. The leaflets 20, 22 spread apart in the atrial direction, until each leaflet meets with the mitral annulus.

[0351] Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow’s Disease, fibroelastic deficiency, etc.), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) may distort a native valve’s geometry, which may cause the nativeAttorney Docket No: TMTTEER-14077W001 valve to dysfunction. However, the majority of subjects undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets 20, 22) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.

[0352] Generally, a native valve may malfunction in different ways: including (1) valve stenosis; and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium).

[0353] There are three main mechanisms by which a native valve becomes regurgitant — or incompetent — which include Carpentier’ s type I, type II, and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier’s type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaptation. A Carpentier’s type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease or dilation of a ventricle.

[0354] Referring to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV is displaced into the left atrium LA during systole so that the edges of the leaflets 20, 22 are not in contact with each other. This failure to coapt causes a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back into the left atrium LA from the left ventricle LV during systole, as illustrated by the mitral regurgitation MR flow path shown inAttorney Docket No: TMTTEER-14077W001FIG. 3. Referring to FIG. 6, the gap 26 may have a width W between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some situations, the gap 26 may have a width W greater than 15 mm or even 17.5 mm. As set forth above, there are several different ways that a leaflet (e.g., leaflets 20, 22 of mitral valve MV) may malfunction which may thereby lead to valvular regurgitation.

[0355] In any of the above-mentioned situations, a valve treatment device or valve repair device (e.g., an implantable device, implant, treatment device, etc.) is desired that is capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit regurgitation of blood through the mitral valve MV. As can be seen in FIG. 4, an abstract representation of a valve treatment device / valve repair device, an implantable device, or implant 10 is shown implanted between the leaflets 20, 22 such that regurgitation does not occur during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation element (e.g., spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) of the device 10 has a generally tapered or triangular shape that naturally adapts to the native valve geometry and to its expanding leaflet nature (toward the annulus). In this application, the terms spacer, coaptation element, coaptation element, gap filler, plug, etc. are used interchangeably and refer to an element that fills a portion of the space between native valve leaflets and / or that is configured such that the native valve leaflets engage or “coapt” against (e.g., such that the native leaflets coapt against the coaptation element, coaptation element, spacer, etc. instead of only against one another).

[0356] Although stenosis or regurgitation may affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating the flow of blood throughout the body.Attorney Docket No: TMTTEER-14077W001Accordingly, because of the substantially higher pressures on the left side heart dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening.

[0357] Malfunctioning native heart valves can either be repaired or replaced. Repair typically involves the preservation and correction of the subject’s native valve. Replacement typically involves replacing the subject’s native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, treatments for a stenotic aortic valve or stenotic pulmonary valve can be removal and replacement of the valve with a surgically implanted heail valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and / or surrounding tissue, which, as described above, may prevent the mitral valve MV or tricuspid valve TV from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA as shown in FIG. 3). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency.Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation may occur due to the chordae tcndincac CT becoming dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which allows the anterior leaflet 20 and the posterior leaflet 22 to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae CT can be repaired by repairing the chordae tendineae CT or the structure of the mitral valve MV (e.g., by securing the leaflets 20, 22 at the affected portion of the mitral valve).

[0358] The devices and procedures disclosed herein often make reference to repairing the structure of a mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or inhibit regurgitation of blood from the right ventricle into the right atrium. In addition, any of theAttorney Docket No: TMTTEER-14077W001 devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent or inhibit regurgitation of blood from the right ventricle to the right atrium. That is, the valve treatment devices or implants provided herein can be centrally located between the three leaflets 30, 32, 34.

[0359] An example device or implant can optionally have a coaptation element (e.g., spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, a valve treatment device / valve repair device (e.g., implantable device, implant, removable treatment device, temporary treatment device, etc.) can have any combination or subcombination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) is configured to be positioned within the native heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting regurgitation described above. The coaptation element can have a structure that is impervious to blood (or that resists blood flow therethrough) and that allows the native leaflets to close around the coaptation element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native valve leaflets; that is, the device can be used in the native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill a space between improperly functioning native leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely.

[0360] The optional coaptation element (e.g., spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) can have various shapes. In some implementations, the coaptation element can have an elongated cylindrical shape having a round cross-sectional shape. In some implementations, the coaptation element can have an oval cross-sectional shape, an ovoid cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation element can have an atrial portion positioned in orAttorney Docket No: TMTTEER-14077W001 adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a side surface that extends between the native leaflets. In some implementations configured for use in the tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, and the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the side surfaces extend between the native tricuspid leaflets.

[0361] In some implementations, the anchor can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between the two native leaflets. In some implementations configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between the three native leaflets. In some implementations, the anchor can attach to the coaptation element at a location adjacent the ventricular portion of the coaptation element. In some implementations, the anchor can attach to an actuation element (e.g., an actuation shaft, actuation tube, actuation wire, etc.) to which the coaptation element is also attached. In some implementations, the anchor and the coaptation element can be positioned independently with respect to each other by separately moving each of the anchor and the coaptation element along the longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchor and the coaptation element can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the actuation element (e.g., shaft, actuation wire, etc.). The anchor can be configured to be positioned behind a native leaflet when implanted such that the leaflet is grasped by the anchor.

[0362] The device or implant can be configured to be implanted via a delivery system or other means for delivery. The delivery system can comprise one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, tube, combinations of these, etc. The coaptation element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released. The device can be configured for the anchor to be expanded radially away from the still compressed coaptation element initially in order to create a gap between the coaptation element and the anchor. A native leaflet can then be positioned in the gap. The coaptation element can be expanded radially, closing the gap between the coaptation element and the anchor and capturingAttorney Docket No: TMTTEER-14077W001 the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element arc optionally configured to sclf-cxpand. The implantation methods for various examples can be different and are more fully discussed below with respect to each example. Additional information regarding these and other delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, and PCT patent application publication Nos. W02020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. These method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc. mutatis mutandis.

[0363] The disclosed devices or implants can be configured such that the anchor is connected to a leaflet, taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor.

[0364] Referring now to FIGS. 8-15, a schematically illustrated device or implant 100 (e.g., a prosthetic device, a valve treatment device, a valve repair device, implantable device, etc.) is shown in various stages of deployment. The device or implant 100 and other similar devices / implants are described in more detail in PCT patent application publication Nos. WO2018 / 195215, W02020 / 076898, and WO 2019 / 139904, which are incorporated herein by reference in their entirety. The device 100 can include any other features for another device or implant discussed in the present application or the applications cited above, and the device 100 can be positioned to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application or the applications cited above).

[0365] The device or implant 100 is deployed from a delivery system 102. The delivery system 102 can comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, aAttorney Docket No: TMTTEER-14077W001 pathway, combinations of these, etc. The device or implant 100 includes a coaptation portion 104 and an anchor portion 106.

[0366] In some implementations, the coaptation portion 104 of the device or implant 100 includes a coaptation element 110 that is adapted to be implanted between leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets during implantation. The actuation element 112 (as well as other actuation elements disclosed herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the coaptation portion 104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the coaptation portion 104.

[0367] The anchor portion 106 and / or anchors of the device 100 include outer paddles 120 and inner paddles 122 that are, in some implementations, connected between a cap 114 and a coaptation element 110 by portions 124, 126, 128. The portions 124, 126, 128 can be jointed and / or flexible to move between all of the positions described below. The interconnection of the outer paddles 120, the inner paddles 122, the coaptation element 110, and the cap 114 by the portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[0368] In some implementations, the delivery system 102 includes a steerable catheter, implant catheter, and the actuation element 112 (e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation clement 112 extends through a delivery catheter and the coaptation element 110 to the distal end (e.g., a cap 114 or other attachmentAttorney Docket No: TMTTEER-14077W001 portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the coaptation clement 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element (e.g., clamp, clip, lock, sutures, friction fit, buckle, snap fit, lasso, etc.) removably attaches the coaptation element 110 to the delivery system 102, either directly or indirectly, so that the actuation element 112 slides through the collar or other attachment element and, in some implementations, through a coaptation element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106 and / or anchors 108.

[0369] In some implementations, the anchor portion 106 and / or anchors 108 can include attachment portions or gripping members (e.g., gripping arms, clasp arms, etc.). The illustrated gripping members can comprise clasps 130 that include a base or fixed arm 132, a moveable arm 134, optional friction-enhancing elements, other securing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 138. The fixed arms 132 are attached to the inner paddles 122. In some implementations, the fixed arms 132 are attached to the inner paddles 122 with the joint portion 138 disposed proximate the coaptation element 110. The joint portion 138 provides a spring force between the fixed and moveable arms 132, 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 138 is a flexible piece of material integrally formed with the fixed and moveable arms 132, 134. The fixed arms 132 are attached to the inner paddles 122 and remain stationary or substantially stationary relative to the inner paddles 122 when the moveable arms 134 are opened to open the clasps 130 and expose the optional barbs or other friction-enhancing elements 136.

[0370] In some implementations, the clasps 130 are opened by applying tension to actuation lines 116 attached to the moveable arms 134, thereby causing the moveable arms 134 to articulate, flex, or pivot on the joint portions 138. The actuation lines 116 extend through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.Attorney Docket No: TMTTEER-14077W001

[0371] The actuation line 116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps 130 can be spring loaded so that in the closed position the clasps 130 continue to provide a pinching force on the grasped native leaflet. Optional barbs or other friction-enhancing elements 136 of the clasps 130 can grab, pinch, and / or pierce the native leaflets to further secure the native leaflets.

[0372] During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and a coaptation element 110 (e.g., a spacer, plug, membrane, etc.). The clasps 130 can be used to grasp and / or further secure the native leaflets by engaging the leaflets with optional barbs or other friction-enhancing elements 136 and pinching the leaflets between the moveable and fixed arms 134, 132. The optional barbs or other frictionenhancing elements 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps 130 increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines 116 can be actuated separately so that each clasp 130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 130 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.

[0373] Referring now to FIG. 8, the device 100 is shown in an elongated or fully open condition for deployment from an implant delivery catheter of the delivery system 102. The device 100 is disposed at the end of the catheter of the delivery system 102 in the fully open position. In the elongated condition the cap 114 is spaced apart from the coaptation element 110 such that the paddles 120, 122 are fully extended. In some implementations, an angle formed between the interior of the outer and inner paddles 120, 122 is approximately 180 degrees. The clasps 130 can be kept in a closed condition during deployment through the delivery system. The actuation lines 116 can extend and attach to the moveable arms 134.Attorney Docket No: TMTTEER-14077W001

[0374] Referring now to FIG. 9, the device 100 is shown in an elongated condition, similar to FIG. 8, but with the clasps 130 in a fully open position, ranging from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees between fixed and moveable arms 132, 134 of the clasps 130.

[0375] Referring now to FIG. 10, the device 100 is shown in a shortened or fully closed condition. To move the device 100 from the elongated condition to the shortened condition, the actuation element 112 is retracted to pull the cap 114 towards the coaptation element 110. The connection portion(s) 126 (e.g., joint(s), flexible connection(s), etc.) between the outer paddle 120 and inner paddle 122 are constrained in movement such that compression forces acting on the outer paddle 120 from the cap 114 being retracted towards the coaptation element 110 cause the paddles or gripping elements to move radially outward. During movement from the open position to the closed position, the outer paddles 120 maintain an acute angle with the actuation element 112. The outer paddles 120 can optionally be biased toward a closed position. The inner paddles 122 during the same motion move through a considerably larger angle as they arc oriented away from the coaptation element 110 in the open condition and collapse along the sides of the coaptation element 110 in the closed condition.

[0376] Referring now to FIGS. 11-13, the device 100 is shown in a partially open, grasp-ready condition. To transition from the fully closed to the partially open condition, the actuation element (e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling on the outer paddles 120, which in turn pull on the inner paddles 122, causing the anchors or anchor portion 106 to partially unfold. The actuation lines 116 are also retracted to open the clasps 130 so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation element 112. Also, the positions of the clasps 130 are dependent on the positions of the paddles 122, 120. For example, referring to FIG. 10 closing the paddles 122, 120 also closes the clasps. In some implementations, the paddles 120, 122 can be independently controllable. In the example illustrated by FIG. 15, the device 100 can have two actuation elements 111, 113 and two independent caps 115, 117 (or other attachment portions), such that one independent actuation element (e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.) and cap (or otherAttorney Docket No: TMTTEER-14077W001 attachment portion) are used to control one paddle, and the other independent actuation element and cap (or other attachment portion) arc used to control the other paddle.

[0377] Referring now to FIG. 12, one of the actuation lines 116 is extended to allow one of the clasps 130 to close. Referring now to FIG. 13, the other actuation line 116 is extended to allow the other clasp 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0378] Referring now to FIG. 14, the device 100 is shown in a fully closed and deployed condition. The delivery system 102 and actuation element 112 are retracted and the paddles 120, 122 and clasps 130 remain in a fully closed position. Once deployed, the device 100 can be maintained in the fully closed position with a mechanical latch or can be biased to remain closed through the use of spring materials, such as steel, other metals, plastics, composites, etc. or shape-memory alloys such as Nitinol. For example, the connection portions 124, 126, 128, the joint portions 138, and / or the inner and outer paddles 122, and / or an additional biasing component (not shown) can be formed of metals such as steel or shape-memory alloy, such as Nitinol — produced in a wire, sheet, tubing, or laser sintered powder — and are biased to hold the outer paddles 120 closed around the coaptation element 110 and the clasps 130 pinched around native leaflets. Similarly, the fixed and moveable arms 132, 134 of the clasps 130 are biased to pinch the leaflets. In some implementations, the attachment or connection portions 124, 126, 128, joint portions 138, and / or the inner and outer paddles 122, and / or an additional biasing component (not shown) can be formed of any other suitably elastic material, such as a metal or polymer material, to maintain the device 100 in the closed condition after implantation.

[0379] FIG. 15 illustrates an example where the paddles 120, 122 are independently controllable. The device 101 illustrated by FIG. 15 is similar to the device illustrated by FIG. 11, except the device 100 of FIG. 15 includes an actuation element that is configured as two independent actuation elements 111, 113 that are coupled to two independent caps 115, 117. To transition a first inner paddle 122 and a first outer paddle 120 from the fully closed to the partially open condition, the actuation element 111 is extended to push the cap 115 away from the coaptation clement 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the first anchor 108 to partially unfold. To transition a second inner paddle 122 andAttorney Docket No: TMTTEER-14077W001 a second outer paddle 120 from the fully closed to the partially open condition, the actuation element 113 is extended to push the cap 115 away from the spacer or coaptation element 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the second anchor 108 to partially unfold. The independent paddle control illustrated by FIG. 15 can be implemented on any of the devices disclosed by the present application. For comparison, in the example illustrated by FIG. 11, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation element 112.

[0380] Referring now to FIGS. 16-21, the device 100 of FIGS. 8-14 is shown being delivered and deployed within the native mitral valve MV of the heart H. Referring to FIG. 16, a delivery sheath / catheter is inserted into the left atrium LA through the septum and the implant / device 100 is deployed from the delivery catheter / sheath in the fully open condition as illustrated in FIG. 16. The actuation element 112 is then retracted to move the implant / device into the fully closed condition shown in FIG. 17.

[0381] As can be seen in FIG. 18, the implant / device is moved into position within the mitral valve MV into the ventricle LV and partially opened so that the leaflets 20, 22 can be grasped. For example, a steerable catheter can be advanced and steered or flexed to position the steerable catheter as illustrated by FIG. 18. The implant catheter connected to the implant / device can be advanced from inside the steerable catheter to position the implant as illustrated by FIG. 18.

[0382] Referring now to FIG. 19, the implant catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 in the clasps 130. An actuation line 116 is extended to close one of the clasps 130, capturing a leaflet 20. FIG. 20 shows the other actuation line 116 being then extended to close the other clasp 130, capturing the remaining leaflet 22. Lastly, as can be seen in FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuation element 112 and actuation lines 116 are then retracted and the device or implant 100 is fully closed and deployed in the native mitral valve MV.

[0383] Any of the features disclosed by the present application can be used in a wide variety of different valve treatment devices. FIGS. 22-24 illustrate examples of valve treatment devices that can be modified to include any of the features disclosed by the present application. Any combination or sub-combination of the features disclosed by the present application can beAttorney Docket No: TMTTEER-14077W001 combined with, substituted for, and / or added to any combination or sub-combination of the features of the valve treatment devices illustrated by FIGS. 8-24.

[0384] Referring now to FIG. 22, an example of a valve treatment device described for illustrative purposes as an implantable device or implant 200 is shown. The device 200 is one of the many different configurations that the device 100 that is schematically illustrated in FIGS. 8- 14 can take. The device 200 can include any other features for a device or implant discussed in the present application, and the device 200 can be positioned to engage valve tissue of leaflets 20, 22 as part of any suitable valve treatment system or valve repair system (e.g., any valve treatment system or repair system disclosed in the present application). The device / implant 200 can be a prosthetic spacer device, valve treatment device, or another type of implant that attaches to leaflets of a native valve.

[0385] In some implementations, the device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaptation element, plug, membrane, sheet, gap filler, plug, wedge, balloon, etc.) for implantation between leaflets of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in a variety of ways. In some implementations, each anchor 208 includes outer paddles 220, inner paddles 222, paddle extension members or paddle frames 224, and clasps 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging with a capture mechanism of a delivery system. A delivery system for the device 200 can be the same as or similar to delivery system 102 described above and can comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The capture mechanism can be configured in a variety of ways and, in some implementations, can comprise one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.

[0386] In some implementations, the coaptation clement 210 and paddles 220, 222 arc formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed inAttorney Docket No: TMTTEER-14077W001 any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire — such as Nitinol — to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.

[0387] An actuation element (e.g., actuation wire, shaft, tube, hypotube, line, suture, braid, etc.) can extend from a delivery system (not shown) to engage and enable actuation of the device or implant 200. In some implementations, the actuation element extends through the proximal collar 211, and spacer or coaptation element 210 to engage a cap 214 of the distal portion 207. The actuation element can be configured to removably engage the cap 214 with a threaded connection, or the like, so that the actuation element can be disengaged and removed from the device 200 after implantation.

[0388] The coaptation element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddles 222. In some implementations, the coaptation element 210 has a generally elongated and round shape, though other shapes and configurations arc possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above and has a tapered shape or cross-section when seen from a front view and a round shape or cross-section when seen from a side view. A blend of these three geometries can result in the three-dimensional shape of the illustrated coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 can also be seen, when viewed from above, to substantially follow or be close to the shape of the paddle frames 224.

[0389] The size and / or shape of the coaptation element 210 can be selected to minimize the number of implants that a single subject will require (preferably one), while at the same time maintaining low transvalvular gradients. In some implementations, the anterior-posterior distance at the top of the coaptation element is about 5 mm, and the medial-lateral distance of the coaptation element at its widest is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior- posterior distance and medial-lateral distance as starting points for the device will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions.Attorney Docket No: TMTTEER-14077W001

[0390] In some implementations, the outer paddles 220 are jointably attached to the cap 214 of the distal portion 207 by connection portions 221 and to the inner paddles 222 by connection portions 223. The inner paddles 222 are jointably attached to the coaptation element by connection portions 225. In this manner, the anchors 208 are configured similar to legs in that the inner paddles 222 are like upper portions of the legs, the outer paddles 220 are like lower portions of the legs, and the connection portions 223 are like knee portions of the legs.

[0391] In some implementations, the inner paddles 222 are stiff, relatively stiff, rigid, have rigid portions and / or are stiffened by a stiffening member or a fixed portion of the clasps 230. The inner paddle 222, the outer paddle 220, and the coaptation element can all be interconnected as described herein.

[0392] In some implementations, the paddle frames 224 are attached to the cap 214 at the distal portion 207 and extend to the connection portions 223 between the inner and outer paddles 222, 220. In some implementations, the paddle frames 224 are formed of a material that is more rigid and stiff than the material forming the paddles 222, 220 so that the paddle frames 224 provide support for the paddles 222, 220.

[0393] The paddle frames 224 can provide additional pinching force between the inner paddles 222 and the coaptation element 210 and assist in wrapping the leaflets around the sides of the coaptation element 210. That is, the paddle frames 224 can be configured with a round three- dimensional shape extending from the cap 214 to the connection portions 223 of the anchors 208. The connections between the paddle frames 224, the outer and inner paddles 220, 222, the cap 214, and the coaptation element 210 can constrain each of these parts to the movements and positions described herein. In particular the connection portion 223 is constrained by its connection between the outer and inner paddles 220, 222 and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connection portion 223 (and thus the inner and outer paddles 222, 220) and to the cap 214.

[0394] The wide configuration of the paddle frames 224 provides increased surface area compared to the inner paddles 222 alone. The increased surface area can distribute the clampingAttorney Docket No: TMTTEER-14077W001 force of the paddles 220 and paddle frames 224 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue.

[0395] Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO 2018 / 195215). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No.PCT / US2018 / 028189 (International Publication No. WO 2018 / 195215). Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO 2018 / 195215) is incorporated herein by reference in its entirety.

[0396] Referring now to FIG. 23, an example of a device or implant 300 is shown. The device 300 is one of the many different configurations that the device 100 that is schematically illustrated in FIGS. 8-14 can take. The device 300 can include any other features for a device or implant discussed in the present application, and the device 300 can be positioned to engage valve tissue of leaflets 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).

[0397] The device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a coaptation portion 304, and the coaptation portion 304 can optionally include a coaptation element 310 (e.g., spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, e.g., outer paddles 320, inner paddles 322, paddle extension members or paddle frames 324. The anchors can also include and / or be coupled to clasps 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism of a delivery system.

[0398] The anchors 308 can be attached to the other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, welding, sutures, adhesive, links, latches,Attorney Docket No: TMTTEER-14077W001 integrally formed, a combination of some or all of these, etc.). In some implementations, the anchors 308 arc attached to a coaptation element 310 by connection portions 325 and to a cap 314 by connection portions 321.

[0399] The anchors 308 can comprise first portions or outer paddles 320 and second portions or inner paddles 322 separated by connection portions 323. The connection portions 323 can be attached to paddle frames 324 that are hingeably attached to a cap 314 or other attachment portion. In this manner, the anchors 308 are configured similar to legs in that the inner paddles 322 are like upper portions of the legs, the outer paddles 320 are like lower portions of the legs, and the connection portions 323 are like knee portions of the legs.

[0400] In implementations with a coaptation element 310, the coaptation element 310 and the anchors 308 can be coupled together in various ways. As shown in the illustrated example, the coaptation element 310 and the anchors 308 can be coupled together by integrally forming the coaptation element 310 and the anchors 308 as a single, unitary component. This can be accomplished, for example, by forming the coaptation element 310 and the anchors 308 from a continuous strip 301 of a braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the coaptation element 310, the outer paddle portions 320, the inner paddle portions 322, and the connection portions 321, 323, 325 are formed from a continuous strip 301.

[0401] Like the anchors 208 of the device or implant 200 described above, the anchors 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar' 311 or other attachment element, etc.) of the device.

[0402] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connection portions 323 of the anchors 308 are adjacent the longitudinal axis of the spacer or coaptation element 310. From the straight configuration, the anchors 308Attorney Docket No: TMTTEER-14077W001 can be moved to a fully folded configuration (e.g., FIG. 23), e.g., by moving the proximal end and distal end toward each other and / or toward a midpoint or center of the device.

[0403] In some implementations, the clasps comprise a moveable ami coupled to an anchor. In some implementations, the clasps 330 include a base or fixed arm 332, a moveable arm 334, optional barbs / friction-enhancing elements 336, and a joint portion 338. The fixed arms 332 are attached to the inner paddles 322, with the joint portion 338 disposed proximate the coaptation element 310. The joint portion 338 is spring-loaded so that the fixed and moveable arms 332, 334 are biased toward each other when the clasp 330 is in a closed condition.

[0404] The fixed arms 332 are attached to the inner paddles 322 through holes or slots with sutures. The fixed arms 332 can be attached to the inner paddles 322 with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms 332 remain substantially stationary relative to the inner paddles 322 when the moveable arms 334 arc opened to open the clasps 330 and expose the optional barbs 336. The clasps 330 are opened by applying tension to actuation lines attached to the moveable arms 334, thereby causing the moveable arms 334 to articulate, pivot, and / or flex on the joint portions 338.

[0405] In short, the device or implant 300 is similar in configuration and operation to the device or implant 200 described above, except that the coaptation element 310, outer paddles 320, inner paddles 322, and connection portions 321, 323, 325 are formed from the single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frames 324 by being woven or inserted through openings in the proximal collar 311, cap 314, and paddle frames 324 that are configured to receive the continuous strip of material 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of the strip of material 301 and other portions are formed from multiple overlapping or overlying layers of the strip of material 301.

[0406] For example, FIG. 23 shows a coaptation element 310 and inner paddles 322 formed from multiple overlapping layers of the strip of material 301. The single continuous strip of material 301 can stall and end in various locations of the device 300. The ends of the strip ofAttorney Docket No: TMTTEER-14077W001 material 301 can be in the same location or different locations of the device 300. For example, in the illustrated example of FIG. 23, the strip of material 301 begins and ends in the location of the inner paddles 322.

[0407] As with the device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants that a single subject will require (preferably one), while at the same time maintaining low transvalvular gradients. In particular, forming many components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance of the device 300 (i.e., the width of the paddle frames 324 which are wider than the coaptation element 310) at its widest is about 5 mm.

[0408] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system arc disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO 2020 / 076898). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO 2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO 2020 / 076898) is incorporated herein by reference in its entirety.

[0409] FIG. 24 illustrates an example of one of the many valve treatment systems or valve repair systems 400 for treating or repairing a native valve of a subject that the concepts of the present application can be applied to. The valve treatment system or valve repair system 400 includes a delivery device 401 and a valve treatment device or valve repair device 402.

[0410] The valve treatment device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408 (e.g., clasps, clasp arms, grippers, gripping arms, latches, etc.). In one example, the paddles 406 can be integrally formed with the base assembly. For example, the paddles 406 can be formed as extensions of links of the base assembly. In the illustrated example, the base assembly 404 of the valve treatment device 402 has a shaft 403, a coupler 405Attorney Docket No: TMTTEER-14077W001 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406, such that movement of the coupler 405 along the shaft 403 causes the paddles to move between an open position and a closed position. In this way, the coupler 405 serves as a means for mechanically coupling the paddles 406 to the shaft 403 and, when moving along the shaft 403, for causing the paddles 406 to move between their open and closed positions.

[0411] In some implementations, the gripping members 408 are pivotally connected to the base assembly 404 (e.g., the gripping members 408 can be pivotally connected to the shaft 403, or any other suitable member of the base assembly), such that the gripping members can be moved to adjust the width of the opening 414 between the paddles 406 and the gripping members 408. The gripping member 408 can include a barbed portion 409 for attaching the gripping members to valve tissue when the valve treatment device 402 is attached to the valve tissue. When the paddles 406 are in the closed position, the paddles engage the gripping members 408, such that, when valve tissue is attached to the barbed portion 409 of the gripping members, the paddles secure the valve treatment device 402 to the valve tissue. In some implementations, the gripping members 408 are configured to engage the paddles 406 such that the barbed portion 409 engages the valve tissue member and the paddles 406 to secure the valve treatment device 402 to the valve tissue member. For example, it can be advantageous to have the paddles 406 maintain an open position and have the gripping members 408 move outward toward the paddles 406 to engage valve tissue and the paddles 406.

[0412] While the example shown in FIG. 24 illustrates a pair of paddles 406 and a pair of gripping members 408, it should be understood that the valve treatment device 402 can include any suitable number of paddles and gripping members.

[0413] In some implementations, the valve treatment system 400 includes a placement shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the valve treatment device 402. After the valve treatment device 402 is secured to valve tissue, the placement shaft 413 is removed from the shaft 403 to remove the valve treatment device 402 from the remainder of the valve treatment system 400, such that the valve treatment device 402 can remain attached to the valve tissue, and the delivery device 401 can be removed from a patient’s body.

[0414] The valve treatment system 400 can also include a paddle control mechanism 410, a gripper control mechanism 411, and a lock control mechanism 412. The paddle controlAttorney Docket No: TMTTEER-14077W001 mechanism 410 is mechanically attached to the coupler 405 to move the coupler along the shaft, which causes the paddles 406 to move between the open and closed positions. The paddle control mechanism 410 can take any suitable form, and can comprise, for example, a shaft, wire, tube, hypotube, rod, suture, line, etc. For example, the paddle control mechanism can comprise a hollow shaft, a catheter tube or a sleeve that fits over the placement shaft 413 and the shaft 403 and is connected to the coupler 405.

[0415] The gripper control mechanism 411 is configured to move the gripping members 408 such that the width of the opening 414 between the gripping members and the paddles 406 can be altered. The gripper control mechanism 411 can take any suitable form, such as, for example, a line, a suture or wire, a rod, a catheter, a tube, a hypotube, etc.

[0416] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 locks the coupler 405 in a stationary position with respect to the shaft 403 and can take a wide variety of different forms and the type of lock control mechanism 412 can be dictated by the type of lock used. In examples in which the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to move the plate between the tilted and substantially non-tilted positions. The lock control mechanism 412 can be, for example, a rod, a suture, a wire, or any other member that is capable of moving a pivotable plate of the lock 407 between a tilted and substantially non-tilted position.

[0417] The valve treatment device 402 is movable from an open position to a closed position. The base assembly 404 includes links that are moved by the coupler 405. The coupler 405 is movably attached to the shaft 403. In order to move the valve treatment device from the open position to the closed position, the coupler 405 is moved along the shaft 403, which moves the links.

[0418] The gripper control mechanism 411 is moves the gripping members 408 to provide a wider or a narrower gap at the opening 414 between the gripping members and the paddles 406. In the illustrated example, the gripper control mechanism 411 includes a line, such as a suture, a wire, etc. that is connected to an opening in an end of the gripping members 408. When the line(s) is pulled, the gripping members 408 move inward, which causes the opening 414 between the gripping members and the paddles 406 to become wider.Attorney Docket No: TMTTEER-14077W001

[0419] In order to move the valve treatment device 402 from the open position to the closed position, the lock 407 is moved to an unlocked condition by the lock control mechanism 412. Once the lock 407 is in the unlocked condition, the coupler 405 can be moved along the shaft 403 by the paddle control mechanism 410.

[0420] After the paddles 406 are moved to the closed position, the lock 407 is moved to the locked condition by the lock control mechanism 412 to maintain the valve treatment device 402 in the closed position. After the valve treatment device 402 is maintained in the locked condition by the lock 407, the valve treatment device 402 is removed from the delivery device 401 by disconnecting the shaft 403 from the placement shaft 413. In addition, the valve treatment device 402 is disengaged from the paddle control mechanism 410, the gripper control mechanism 411, and the lock control mechanism 412.

[0421] Additional features of the device 402, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904) is incorporated herein by reference in its entirety.

[0422] Clasps or leaflet gripping devices disclosed herein can take a wide variety of different forms. Examples of clasps are disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201) is incorporated herein by reference in its entirety.Attorney Docket No: TMTTEER-I4077W001

[0423] Referring to FIGS. 25A-25B, an example of a valve treatment device 402 has a coaptation element 3800. The valve treatment device 402 can have the same configuration as the valve treatment device illustrated by FIG. 24 with the addition of the coaptation element. The coaptation element 3800 can take a wide variety of different forms. The coaptation element 3800 can be compressible and / or expandable. For example, the coaptation element can be compressed to fit inside one or more catheters of a delivery system, can expand when moved out of the one or more catheters, and / or can be compressed by the paddles 406 to adjust the size of the coaptation element. In the example illustrated by FIGS. 25 A and 25B, the size of the coaptation element 3800 can be reduced by squeezing the coaptation element with the paddles 406 and can be increased by moving the paddles 406 away from one another. The coaptation element 3800 can extend past outer edges 4001 of the gripping members or clasps 408 as illustrated for providing additional surface area for closing the gap of a mitral valve.

[0424] The coaptation element 3800 can be coupled to the valve treatment device 402 in a variety of different ways. For example, the coaptation clement 3800 can be fixed to the shaft 403, can be slidably disposed around the shaft, can be connected to the coupler 405, can be connected to the lock 407, and / or can be connected to a central portion of the clasps or gripping members 408. In some implementations, the coupler 405 can take the form of the coaptation element 3800. That is, a single element can be used as the coupler 405 that causes the paddles 406 to move between the open and closed positions and the coaptation element 3800 that closes the gap between the leaflets 20, 22 when the valve treatment device 402 is attached to the leaflets.

[0425] The coaptation element 3800 can be disposed around one or more of the shafts or other control elements of the valve treatment system 400. For example, the coaptation element 3800 can be disposed around the shaft 403, the shaft 413, the paddle control mechanism 410, and / or the lock control mechanism 412.

[0426] The valve treatment device 402 can include any other features for a valve treatment device or valve repair device discussed in the present application, and the valve repair device 402 can be positioned to engage valve tissue as part of any suitable valve treatment system or valve repair system (e.g., any valve treatment system or valve repair system disclosed in the present application). Additional features of the device 402, modified versions of the device, deliveryAttorney Docket No: TMTTEER-I4077W001 systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No.PCT / US2019 / 012707 (International Publication No. WO 2019139904).

[0427] FIGS. 26-30 illustrate an example of one of the many valve treatment systems or valve repair systems for repairing a native valve of a patient that the concepts of the present application can be applied to. Referring to FIGS. 29 and 30, the valve treatment system includes an implant catheter assembly 1611 and an implantable valve treatment device 8200. Referring to FIGS. 26- 28, the device 8200 includes a proximal or attachment portion 8205, paddle frames 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frames 8224 can be configured in a variety of ways.

[0428] In the example illustrated in FIG. 26, the paddle frames 8224 can be symmetric along longitudinal axis YY. However, in some implementations, the paddle frames 8224 are not symmetric about the axis YY. Moreover, referring to FIG. 26, the paddle frames 8224 include outer frame portions 8256 and inner frame portions 8260.

[0429] In some implementations, the connector 8266 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) attaches to the outer frame portions 8256 at outer ends of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 (see FIG. 28). Between the connector 8266 and the attachment portion 8205, the outer frame portions 8256 form a curved shape. For example, in the illustrated example, the shape of the outer frame portions 8256 resembles an apple shape in which the outer frame portions 8256 are wider toward the attachment portion 8205 and narrower toward the distal portion 8207. In some implementations, however, the outer frame portions 8256 can be otherwise shaped.

[0430] The inner frame portions 8260 extend from the attachment portion 8205 toward the distal portion 8207. The inner frame portions 8260 then extend inward to form retaining portions 8272Attorney Docket No: TMTTEER-14077W001 that are attached to the actuation cap 8214. The retaining portions 8272 and the actuation cap 8214 can be configured to attach in any suitable manner.

[0431] In some implementations, the inner frame portions 8260 are rigid frame portions, while the outer frame portions 8256 are flexible frame portions. The proximal end of the outer frame portions 8256 connect to the proximal end of the inner frame portions 8260, as illustrated in FIG. 26.

[0432] The width adjustment element 8211 (e.g., width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move the outer frame portions 8256 from the expanded position to the narrowed position by pulling the inner end 8968 (FIG. 28) and portions of the connector 8266 into the actuation cap 8214. The actuation element 8102 is configured to move the inner frame portions 8260 to open and close the paddles in accordance with some implementations disclosed herein.

[0433] As shown in FIGS. 27 and 28, the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a cylinder, tracks, etc.) to move the outer frame portions 8256 between a narrowed position and an expanded position. In the illustrated example, the inner end 8968 includes a post 8970 that attaches to the outer frame portions 8256 and a coupler 8972 that extends from the post 8970. The coupler 8972 is configured to attach and detach from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a wide variety of different forms. For example, the coupler 8972 can include one or more of a threaded connection, features that mate with threads, detent connections, such as outwardly biased arms, walls or other portions. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. When the coupler 8972 is detached from the width adjustment element 8211, the coupler is secured to the receiver. The inner end 8968 of the connector can, however, be configured in a variety of ways. Any configuration that can suitably attach the outer frame portions 8256 to the coupler to allow the width adjustment element 8211 to move the outer frame portions 8256Attorney Docket No: TMTTEER-14077W001 between the narrowed position and the expanded position can be used. The coupler can be configured in a variety of ways as well and can be a separate component or be integral with another portion of the device, e.g., of the connector or inner end of the connector.

[0434] The width adjustment element 8211 allows a user to expand or contract the outer frame portions 8256 of the device 8200. In the example illustrated in FIGS. 27 and 28, the width adjustment element 8211 includes an externally threaded end that is threaded into the coupler 8972. The width adjustment element 8211 moves the coupler in the receiver 8912 to adjust the width of the outer frame portions 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame portions 8256.

[0435] In some implementations, the receiver 8912 can be integrally formed with a distal cap 8214. Moving the cap 8214 relative to a body of the attachment portion 8205 opens and closes the paddles. In the illustrated example, the receiver 8912 slides inside the body of the attachment portion. When the coupler 8972 is detached from the width adjustment element 8211, the width of the outer frame portions 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to a body of the attachment portion 8205. Movement of the cap can open and close the device in the same manner as the other examples disclosed above.

[0436] In the illustrated example, a driver head 8916 is disposed at a proximal end of the actuation element 8102. The driver head 8916 releasably couples the actuation element 8102 to the receiver 8912. In the illustrated example, the width adjustment element 8211 extends through the actuation element 8102. The actuation element is axially advanced in the direction opposite to direction Y to move the distal cap 8214. Movement of the distal cap 8214 relative to the attachment portion 8205 is effective to open and close the paddles, as indicated by the arrows in FIG. 27. That is, movement of the distal cap 8214 in the direction Y closes the device and movement of the distal cap in the direction opposite to direction Y opens the device.

[0437] Also illustrated in FIGS. 27 and 28, the width adjustment element 8211 extends through the actuation element 8102, the driver head 8916, and the receiver 8912 to engage the coupler 8972 attached to the inner end 8968. The movement of the outer frame portions 8256 to the narrowed position can allow the device or implant 8200 to maneuver more easily into positionAttorney Docket No: TMTTEER-14077W001 for implantation in the heart by reducing the contact and / or friction between the native structures of the heart — c.g., chordae — and the device 8200. The movement of the outer frame portions 8256 to the expanded position provides the anchor portion of the device or implant 8200 with a larger surface area to engage and capture leaflet(s) of a native heart valve.

[0438] Referring to FIGS. 29 and 30, an example of an implant catheter assembly 1611 in which clasp actuation lines 624 extend through a handle 1616, the actuation element 8102 is coupled to a paddle actuation control 1626, and the width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of the shaft or catheter of the implant catheter assembly 1611 can be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter can be coupled to the device 8200. The actuation element 8102 can extend distally from the paddle actuation control 1626, through the handle 1616, through the delivery shaft or catheter of the implant catheter assembly 1611, and through the proximal end of the device 8200, where it couples with the driver head 8916. The actuation element 8102 can be axially movable relative to the outer shaft of the implant catheter assembly 1611 and the handle 1616 to open and close the device.

[0439] The width adjustment element 8211 can extend distally from the paddle width control 1628, through the paddle actuation control 1626 and through the actuation element 8102 (and, consequently, through the handle 1616, the outer shaft of the implant catheter assembly 1611, and through the device 8200), where it couples with the movable coupler 8972. The width adjustment element 8211 can be axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611, and the handle 1616. The clasp actuation lines 624 can extend through and be axially movable relative to the handle 1616 and the outer shaft of the implant catheter assembly 1611. The clasp actuation lines 624 can also be axially movable relative to the actuation element 8102.

[0440] Referring to FIGS. 29 and 30, the width adjustment element 8211 can be releasably coupled to the coupler 8972 of the device 8200. Advancing and retracting the width adjustment element 8211 with the paddle width control 1628 widens and narrows the paddles. Advancing and retracting the actuation clement 8102 with the paddle actuation control 1626 opens and closes the paddles of the device.Attorney Docket No: TMTTEER-14077W001

[0441] In the examples of FIGS. 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongate shaft extending axially between the proximal end portion 1622a, which is coupled to the handle 1616, and the distal end portion 1622b, which is coupled to the device 8200. The outer shaft of the implant catheter assembly 1611 can also include an intermediate portion 1622c disposed between the proximal and distal end portions 1622a, 1622b.

[0442] In various examples, a delivery apparatus is configured to make it easier to move the device or implant between its various configurations and / or to implant (and / or deliver) the device or implant in the native heart valve. For example, controls on a handle used in a delivery assembly can be configured to enable improved control of the device or implant, as will be described.

[0443] Figures 31-32 show an example of a delivery assembly 600 and its components. Referring to Figure 31, the delivery assembly 600 can comprise the delivery apparatus 602 and a device 604 (e.g., a treatment device, a repair device, an implant, an implantable device, a valve repair device, etc.). The delivery apparatus 602 can comprise a plurality of catheter assemblies and optional catheter stabilizers (not shown in Figures 31 and 32). For example, in the illustrated example, the delivery apparatus 602 includes a delivery catheter assembly 606, a steerable catheter assembly 608, and a device / implant catheter assembly 610 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.). The steerable catheter assembly 608 extends coaxially through the delivery catheter assembly 606, and the device / implant catheter assembly 610 extends coaxially through the steerable catheter assembly 608 and the delivery catheter assembly 606. The device 604 can be releasably coupled to a distal portion of the device / implant catheter assembly 610, as further described below. It should be appreciated that the device 604 can be any device described herein.

[0444] As shown in Figure 32, each of the delivery catheter assembly 606, the steerable catheter assembly 608, and the device / implant catheter assembly 610 includes a sheath or shaft 607, 609, 611 extending from a handle 612, 614, 616, respectively. The handles 612, 614, 616 are located at a proximal end of each of the corresponding sheaths or shafts, and include one or more control members to enable a user to manipulate the catheter assembly (e.g., bend or rotate the sheath or shaft of the catheter assembly) or control a component coupled to the corresponding catheter assembly (e.g., a control wire extending through the shaft of the catheter assembly).Attorney Docket No: TMTTEER-14077W001

[0445] The delivery catheter assembly 606 and the steerable catheter assembly 608 can be used, for example, to access an implantation location (e.g., a native mitral valve region of a heart) and / or to position the device / implant catheter assembly 610 at the implantation location. Accordingly, in various examples, the delivery catheter assembly 606 and the steerable catheter assembly 608 are configured to be steerable. Features of catheter assemblies disclosed by U.S. Patent No. 10,653,862 and U.S. Patent No. 10,646,342 can be used in the catheter assemblies 606, 608, 610. U.S. Patent No. 10,653,862 and U.S. Patent No. 10,646,342 arc hereby incorporated by reference in their entireties.

[0446] Figure 34 illustrates an example of a device / implant catheter assembly 610. Figure 34 illustrates a generalized device / implant catheter assembly 610. In the example illustrated by Figure 34, the device / implant catheter assembly 610 can comprise the inner or actuation element 112, a coupler, an outer shaft 611, a handle 616 (shown schematically), and clasp actuation lines 624. A proximal end portion 622a of the outer shaft 611 can be coupled to extend distally from the handle 616, and a distal end portion 622b of the outer shaft 611 can be coupled to the coupler. The actuation element 112 can extend distally from the actuation control or knob 626 (shown schematically in Figure 76), through the handle 616, through the outer shaft 611, and through the coupler 620. The actuation element 112 can be movable (e.g., axially and / or rotationally) relative to the outer shaft 611 and the handle 616. The clasp actuation lines 624 can extend through and be axially movable relative to the handle 616 and the outer shaft 611. The clasp actuation lines 624 can also be axially movable relative to the actuation element 112.

[0447] As shown in Figure 34, the actuation element 112 (e.g., actuation rod, actuation tube, actuation shaft, actuation wire, etc.) of the device / implant catheter assembly 610 can be releasably coupled to the cap 114 of the device 604. The actuation element extends from a proximal end portion 112a to a distal end portion 112b. In some implementations, the distal end portion 112b of the actuation element 112 can comprise external threads configured to releasably engage interior threads of the cap 114 of the device 604. As such, rotating the actuation element 112 in a first direction (e.g., clockwise) relative to the cap 114 of the device 604 releasably secures the actuation element 112 to the cap 114, while rotating the actuation element 112 in a second direction (e.g., counterclockwise) relative to the cap 114 of the device 604 releases the actuation element 112 from the cap 114.Attorney Docket No: TMTTEER-14077W001

[0448] In the example of Figure 34, the outer shaft 611 of the device / implant catheter assembly 610 is an elongate shaft extending axially between the proximal end portion 622a, which is coupled to the handle 616, and the distal end portion 622b, which is coupled to the coupler 620. The outer shaft 611 can also include an intermediate portion 622c disposed between the proximal and distal end portions 622a, 622b. The outer shaft 611 can be formed from various materials, including metals and polymers. For example, in one particular example, the proximal end portion 622a can comprise stainless steel and the distal and intermediate portions 622b, 622c can comprise polyether block amide (PEBA). The outer shaft 611 can also comprise an outer covering or coating, such as a polymer that is reflowed over the portions 622a, 622b, and 622c.

[0449] As shown in Figure 34, the clasp actuation lines 624 are coupled to the clasps 130 through holes 235 in the clasps 130 and extend axially through the outer shaft 611 between the clasps 130 and the handle 616. In some implementations, the clasp actuation lines 624 are each coupled to a clasp control member 628 at the proximal end of the clasp actuation lines 624. Each clasp control member 628 can be, for example, an axially-moving control or slider coupled to a corresponding clasp actuation line 624 to axially move the clasp actuation line 624 relative to the outer shaft 611 and the actuation element 112. Each of the clasp control members 628 can be operated independently of the other clasp control member such that each clasp actuation line 624 is moved relative to the outer shaft 611, the actuation element 112, and the other clasp actuation line 624, or the clasp control members 628 can be fixed with respect to one another (c.g., locked) such that the clasp actuation lines 624 are axially moved together relative to the outer shaft 611 and the actuation element 112. Additional information on example clasp control members 628 and device / implant catheter assemblies including the same can be found, for example, in US Provisional Application Serial No. 63 / 181,120, filed on Apr 28, 2021, which is incorporated herein by reference in its entirety.

[0450] In various examples, the handle 1616 including the controls for adjusting the width of the paddle frames can be incorporated into a control system having a variety of forms. For example, the handle 1616 can be incorporated into the control system 1000 shown in Figure 33. Features of the control system illustrated in Figure 33 can be found in U.S. Patent No. 10,820,998, filed April 8, 2020, and entitled “Valve Repair Device,” the entire contents of which is incorporated by reference herein.Attorney Docket No: TMTTEER-14077W001

[0451] Turning now to Figure 35, an example of a handle 616 of a device / implant catheter assembly 610 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) is shown. In Figure 35, the handle 616 includes a housing 632 to which the various controls are coupled. The housing 632 can be formed from various materials, including polymers such as polycarbonate, and can be formed as a unitary body (e.g., through injection molding) or fastened together in any one of a variety of manners, including fasteners, pins, adhesives, or the like. As shown in Figures 36-39, the housing 632 comprises a plurality of lumens, through which the clasp actuation lines 624 and the actuation element (e.g., actuation rod, actuation tube, actuation wire, actuation shaft, etc.) 112 extend.

[0452] The handle 616 further comprises a flush port 638, as shown in Figures 35-37. The flush port 638 is configured for flushing (e.g., with a saline solution) the outer shaft 611 prior to inserting the outer shaft 611 into a patient’s vasculature. Additionally, the flush port 638 enables air present in the outer shaft 611 to be removed as fluid is drawn into the proximal end of the outer shaft 611. Additional information regarding a flush port that can be used in the handle 616 can be found in, for example, International Publication No. WO 2020 / 112622, the entire contents of which is incorporated by reference herein.

[0453] As shown in Figures 35-37, the housing 632 comprises an aperture for receiving a marking pin 640. The marking pin 640 can be removably coupled with the aperture of the housing 632 for storage of the marking pin 640. During use, the marking pin 640 can be removed from the aperture of the housing and inserted into an aperture 641 (shown in Figure 35) on one of the clasp control members 628. For example, the marking pin 640 can be inserted into an aperture 641 on the clasp control member 628 that controls the clasp to be coupled to a posterior leaflet of the mitral valve. Accordingly, in the event that the handle 616 is rotated during use, the user can readily identify the clasp control member 628 for control of the clasp to be coupled to the posterior leaflet (e.g., the marked clasp control member 628) and the clasp control member 628 for control of the clasp to be coupled to the anterior leaflet (e.g., the unmarked clasp control member 628). Although the marking pin 640 is described as being coupled to the clasp control member 628 that controls the clasp to be coupled to the posterior leaflet, it is contemplated that the marking pin 640 can be coupled to either of the clasp control members 628 to indicate any particular orientation of the device / implant catheter assembly.Attorney Docket No: TMTTEER-14077W001

[0454] Also included on the handle 616 is a slide lock 642 that is configured to slide between a first position, in which the slide lock 642 is coupled to one of the clasp control members 628, to a second position, in which the slide lock 642 is coupled to both clasp control members 628. For example, each of the clasp control members 628 can include a flange 643 to which the slide lock642 is slidably coupled. Accordingly, the slide lock 642 can be moved to the first position (as indicated by the arrow shown in Figure 35) in which the slide lock is engaged with the flange643 of one of the clasp control members 628 (c.g., to enable independent movement of each clasp actuation line relative to the other) and the second position (shown in the Figure 35) in which the slide lock 642 is engaged with the flange 643 of both of the clasp control members 628 (e.g., to enable simultaneous movement of the clasp actuation lines) in order to selectively control relative movement between the clasp control members 628. When the slide lock is in the first position, each of the clasp control members is axially movable independently of the other clasp control member, and when the slide lock is in the second position, the clasp control members are axially movable together. Although not shown in the figures, in examples, each flange 643 can include a stop to limit the position of the slide lock 642 along the flange 643.

[0455] In some implementations, each of the clasp control members 628 can include one or more tactile or visual indicators to enable the user to differentiate one clasp control member from the other with improved accuracy. For example, one clasp control member 628 can have a different color and / or texture (c.g., ribbed, smooth) than the other clasp control member 628. As shown in the figures, in some implementations, each of the clasp control members 628 is wrapped approximately 180 degrees around the circumference of the housing 632 such that together the clasp control members 628 surround and encircle the housing 632. Such an arrangement can, for example, enable the clasp control members 628 to be accessible to the user from any angle with a single hand. Moreover, in the example depicted in Figure 68, the clasp control members 628 include a depressed region 644 that is generally shaped to receive and cradle the thumb of the user. Although the inclusion of such a depressed region is optional in some implementations, it can provide comfort for the user and improve the ease of use of the clasp control members 628 when it is included.

[0456] Each clasp control member 628 can further comprise one or more keyed projections or tongues that are configured to be received by and slide along a corresponding groove or slot in the housing 632. As best shown in Figure 40, in examples, the housing 632 further includes a pair of detents 645. A first detent 645 is located at a first axial position along a path of one of theAttorney Docket No: TMTTEER-14077W001 clasp control members 628, and a second detent 645 is located at a second axial position along the path of the clasp control member 628. For example, in Figure 40, one of the detents 645 projects from the housing 632 at a location that places the clasp control member 628 in a fully proximal position (e.g., a fully open position), thereby maintaining the clasp control member 628 in the fully proximal position (e.g., a fully open position) and preventing or inhibiting the clasp control member 628 from moving distally without intention of the user. A second one of the detents 645 projects from the housing 632 at a location that places the clasp control member 628 in a fully distal position (e.g., a fully closed position), thereby maintaining the clasp control member 628 in the fully distal position (e.g., a fully closed position) and preventing or inhibiting the clasp control member 628 from moving proximally without intention of the user. To release the clasp control member 628 for operation of the clasps, the user simply presses the clasp control member 628 with enough force to depresses the detent 645 and slide over the detent 645. When the clasp control member 628 moved to either the proximal position (open) or distal position (closed), the corresponding detent 645 provides tactile and audible feedback to the user indicative that the clasp control member 628 is in the open or closed position.

[0457] Referring to Figure 40, the clasp control member 628 can comprise a coupler 646 configured to attach the clasp control member 628 to a clasp control tube 648. As described in more detail below, the clasp control tube 648 is releasably coupled to the clasp control lines 624. Sliding movement of the clasp control member 628 along the housing moves the clasp control tube 648 relative to the housing 632 to open and close the clasps.

[0458] In the example illustrated by Figures 35 and 36, the coupler 646 includes at least one aperture 647, in which the clasp control tube 648 is connected. The clasp control member 628 is slidably coupled to the housing 632, such as by the mating channels 629 of the housing 632 and the projections 631 of the clasp control member 628 (see Figure 35) and / or by the clasp control tube 648 extending through a guide passage 649 formed in the housing (see Figure 39). The clasp control member, the coupler 646, and the clasp control tube 648 can slide together axially (i.e., distally and proximally) with respect to the housing 632 to open and close the clasp. Only a single coupler 646 and clasp control tube 648 can be seen in Figures 35 and 36. Figure 39 shows that each clasp control member 628 is fixedly coupled and slides in conjunction with a corresponding clasp control tube 648 in the same manner. The clasp control tube 648 can be fixed at a proximal end to a suture lock 650 that is used to secure the clasp control line 624 to the to the clasp control tube 648.Attorney Docket No: TMTTEER-14077W001

[0459] In some implementations, each clasp control tube 648 can comprise one or more optional keying features 671 at various positions or all along the axial length of the clasp control tube 648. In some implementations, no keying features are included. When included, the optional keying features 671 are complementary to corresponding keying features 675 formed in one or more components of the handle 616, such as in the housing 632 of the handle. These keying features 671, 675 can prevent or inhibit rotation of the clasp control tube 648 in the housing and thereby limit movement of the clasp control tube to linear movement along the length of the housing 632. For example, the optional keying feature 671 of the clasp control tube 648 can comprise a wire welded to the external surface of the clasp control tube 648 (see Figure 36). In such implementations, one or more portions of the axial path defined by the handle for the clasp control tube 648, can include a corresponding groove configured to receive the wire and provide a path along which the wire can slide. The optional keying features 671, 675 can enhance stabilization of the clasp control member 628 by preventing or inhibiting rotation or torquing of the clasp control tube 648 within the handle 616. For example, the optional features 671, 675 can prevent or inhibit rotation or torquing of the clasp control tube 648 within the handle 616 when the control lines are pulled by the clasp control tube 648 to open the clasps and / or the control lines are pulled through the clasp control tube 648 to release the clasps.

[0460] Returning to Figure 36, as the clasp control member 628 is moved in a proximal direction, the clasp control tube 648 also moves in the proximal direction, pushing the suture lock 650 in the proximal direction with respect to the handle 616. As the suture lock 650 moves in the proximal direction, the loop of the clasp actuation line 624 extending from the distal end of the outer shaft 611 moves proximally, pulling the clasp 130. To release the clasp 130, such as to grasp the leaflet, the clasp control member 628 is moved in a distal direction, which in turn moves the clasp control tube 648 and suture lock 650 in the distal direction, thereby moving the loop of the clasp actuation line 624 in the distal direction, enabling the clasp 130 to move toward the inner paddles 122, grasping the leaflet between the clasp 130 and the inner paddle 122.

[0461] As previously mentioned, the handle 616 further comprises a knob 626 (or other control, e.g., button, switch, gears, etc.) that is configured to control the position of the actuation element 112 relative to the handle 616 and outer shaft 611. In some implementations, the knob 626 is configured to rotate about an axis of the handle 616. As can be seen in Figures 36-39, the knob 626 can be fixedly coupled to an internally threaded tube 652 positioned within the housing 632 of the handle 616.Attorney Docket No: TMTTEER-14077W001

[0462] In some implementations, when the knob 626 is rotated about the axis of the handle 616, the internally threaded tube 652 rotates with respect to the housing 632. An externally threaded nut or retractor 654 is positioned within and engaged with the internally threaded tube 652. The externally threaded nut or retractor 654 and is rotationally fixed with respect to the housing 632. The externally threaded nut or retractor 654 can be rotationally fixed in a wide variety of different ways. In the example illustrated by Figure 37, a pair of guide rods 661 extend axially within the handle 616, and each of the pair of guide rods 661 is fixed to the housing 632 at both ends of the guide rod 661. A mounting bracket 663 couples the pair of guide rods 661 to the housing 632 at the distal end of each of the pair of guide rods 661. Accordingly, as the internally threaded tube 652 is rotated, the externally threaded retractor 654 is advanced linearly in an axial direction (i.e., distally and proximally) along the pair of guide rods 661.

[0463] The externally threaded retractor 654 is connected to the actuation element 112 such that linear movement of the externally threaded retractor 654 causes linear movement of the actuation element 112, thereby moving the device between a fully elongated configuration, an open configuration, and a closed configuration, as described herein. The translation of the rotational movement of the knob 626 into linear motion of the actuation element 112 can result in improved control and precision, thereby leading to improved precision during the opening and closing of the device.

[0464] The internally threaded tube 652 includes and unthreaded portion 657. A clutch spring 656 is positioned around an unthreaded proximal portion 659 of the retractor 654. The clutch spring presses against a proximal end surface 655 of the threaded portion of the retractor 654. Proximal movement of the actuation element 112 after closure of the device 604 can result in overclosure or compression of the valve repair device or treatment device. The position of the unthreaded portion 657 is selected to prevent or inhibit over-retraction of the actuation element 112 and thereby prevent or inhibit over-closing of the valve repair device. That is, the externally threaded retractor 654 is no longer driven proximally when the externally threaded nut or retractor 654 reaches the unthreaded portion 657. The clutch spring is configured to bias the externally threaded retractor 654 distally (e.g., toward the threads of the internally threaded tube 652) when the externally threaded retractor 654 has reached the end of the threads of the internally threaded tube 652. Continued rotation of the knob 626 following disengagement of the external threads of the externally threaded retractor 654 and the internal threads of the internally threaded tube 652 results in an audible indication that the device is in a closed position. TheAttorney Docket No: TMTTEER-14077W001 biasing of the externally threaded retractor 654 can also reduce slop in the threaded connection, thereby improving stability of the paddle angle. The biasing of the externally threaded retractor 654 towards the internal threads of the internally threaded tube 652 ensures that the externally threaded retractor 654 will be re-engaged by the internally threaded tube 652 when the knob 626 is rotated in an opposite direction that corresponds to advancement of the actuation element 112.

[0465] As shown in Figures 37, 38, and 39, the externally threaded retractor 654 includes a central passage 683. A crimp assembly 668 is coupled in the passage 683. The crimp assembly attaches the actuation element 112 (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.) that is in an actuation tube 669 to the paddle release knob 630. The crimp assembly 668 can take a variety of different forms. In the illustrated example, the crimp assembly 668 comprises a collet 687 and a nut 670. The collet 687 includes external threads and the nut includes internal threads. The collet and nut each have a central bore that is sized to receive the actuation tube 669 which surrounds the actuation element 112. The actuation element 112 can be fixed to the actuation tube 669 near the proximal end of the actuation tube 669. The actuation tube 669 is fixed to the crimp assembly 668, which is fixed to the externally threaded retractor 654. The external threads on the outer surface of the collet 687 engage with the internal threads of the nut 670. When tightened, the collet 687 and nut 670 fix the crimp assembly to both the actuation tube 669 and a shoulder 689 at the proximal end of the retractor 654. The nut is positioned within the central bore 683 of the externally threaded retractor 654. A spring 672 is also positioned within the central bore 683 of the externally threaded retractor 654 such that the nut 670 is biased against the shoulder 689. The positioning of the nut 670 against the shoulder 689 allows the collet 687 to be easily attached to the nut 670.

[0466] In some implementations, in use, the knob 626 is rotated, which rotates the internally threaded tube 652 to rotate with respect to the housing 632, thereby driving the externally threaded retractor 654 axially. The axial movement of the externally threaded retractor 654 causes axial movement of the actuation element 112, which moves the device between a fully elongated configuration, an open configuration, and a closed configuration. Axial movement of the externally threaded retractor 654 also causes axial movement of the release knob 630 between a proximal, or extended, position and a distal, or retracted, position. Accordingly, in implementations, the axial position of the release knob 630 with respect to the housing 632 is a visual indicator of the configuration of the device 604.Attorney Docket No: TMTTEER-14077W001

[0467] Figures 41-43 illustrate an example clasp actuation portion 3631 of the handle 3616. The illustrated clasp actuation portion 3631 includes the clasp control members 3628 which are configured to move the clasps (e.g., 130) of the device via clasp actuation lines (e.g., 624). The clasps 130 can be configured in the same manner as any of the clasps described herein. The clasp actuation portion 3631 can be configured in a variety of ways. In some implementations, the device / implant catheter assembly 3610 includes two clasp actuation lines (e.g., 624), each coupled to a corresponding clasp control member 3628 at the proximal end of the clasp actuation lines (e.g., 624). Each clasp control member 3628 can be, for example, an axially movable control or slider coupled to a corresponding clasp actuation line (e.g., 624) to axially move the clasp actuation line relative to the actuation element 8102. Each of the clasp control members 3628 can be operated independently of the other clasp control member such that each clasp actuation line (e.g., 624) is moved relative to the actuation element 8102 and the other clasp actuation line. The clasp control members 3628 can also be fixed with respect to one another (e.g., locked) such that the clasp actuation lines (e.g., 624) are axially moved together relative to the actuation element 8102.

[0468] The clasp control members 3628 can be configured in a variety of ways, including similar to any clasp control member disclosed herein. In the example depicted in Figure 41, the clasp control members 3628 are similar to the clasp control members 628 of Figure 35, and thus the previous description of the clasp control members 3628 applies equally to the clasp control members 3628 shown in Figure 41. The handle 3616 includes a pair of line-engaging members 3730 configured to engage the clasp actuation lines 3624 to move the lines in response to movement of the clasp control members 3628. The line-engaging members 3730 can be configured in a variety of ways. In the illustrated example, each line-engaging member 3730 is configured as an elongated rod having a proximal end fixed to a corresponding clasp control member 3628 and a distal end configured to engage a corresponding clasp actuation line 3624. In the illustrated example, the distal end of each line-engaging member 3730 includes a laterally extending passage 3732 through which a clasp actuation line 3624 can extend.

[0469] In some implementations, the handle 3616 can include a fluid body housing 3734 positioned within the housing 3632 of the handle 3616. The fluid body housing includes a distal stem 3736 defining a passage 3738, a main body portion 3740 defining an interior space 3742, and a proximal cap 3744. The proximal cap 3744 includes a plurality of orifices 3746 configured to allow the actuation element 8102 and the width adjustment element 8211 to extend throughAttorney Docket No: TMTTEER-14077W001 proximal cap 3744. In addition, each of the pair of line-engaging members 3730 extends distally from the clasp control members 3628 through a corresponding orifice 3746 in the proximal cap 3744 and into the interior space 3742. The main body portion 3740 further includes a line anchor 3748 to which the proximal ends of the clasp actuation lines 3624 attach. The line anchor 3748 can be configured in a variety of ways, including location, orientation, and anchoring means. In the illustrated example, the line anchor 3748 includes a passage 3750 from the interior space 3742 to the exterior of the main body portion 3740 and a boss 3752 surround the passage 3750 to which the clasp actuation lines 3624 attach.

[0470] Figures 44, 45 and 46 illustrate components of an example slider assembly. Figure 44 illustrates one example of one half of a locking ring 4400 for a slider assembly. In some implementations, two of the locking ring 4400 halves are included. In some implementations, each half of the locking ring 4400 includes a body 4402 having an inner surface 4404 and an outer surface 4406.

[0471] Body 4402 is shown in FIG. 44 having a generally arcuate, such as circular, shape, but other shapes are also contemplated such as for example, linear and / or partially polygonal. Outer surface 4406 is shown arcuate in shape. In some implementations, the outer surface 4406 includes a raised portion 4408. Raised portion 4408 can be located anywhere on outer surface 4406. In the example shown, raised portion 4408 can be a tab-like projection located near’ one end portion of outer surface 4406. The location of raised portion 4408 on outer surface 4406 is not critical.

[0472] In some implementations, a recess in outer surface 4406 can be used in the alternative to a raised portion. Further yet, in some implementations, a portion of outer surface 4406 can be textured with grooves, stippling, or other surface features to allow that portion to be differentiated from the rest of outer surface 4406. Raised portion 4408 (or alternative structure) functions as an actuating structure that when pushed against moves locking ring 4400 from, for example, a locking position to an unlocked position (or vice-versa).

[0473] In some implementations, locking ring 4400 further includes a mounting extension 4410 and mounting aperture 4412. Mounting extension 4410 and mounting aperture 4412 are both shown as arcuate in order allow for locking ring 4400 to move along an arcuate surface or direction. In some implementations where the locking ring 4400 has a non-arcuate shape, the mounting extension and mounting aperture may have a corresponding non-arcuate shape (e.g.,Attorney Docket No: TMTTEER-14077W001 linear and / or partially polygonal). Locking ring 4400 is configured to be movably connected to a clasp control member such as, for example, clasp control member 4500 shown in Figure 45.

[0474] Referring now to Figure 45, an example of a clasp control member 4500 is shown. Clasp control member 4500 includes a body 4502 having a channel base surface 4504 and an extension 4506 forming a channel side wall. In some implementations, extension 4506 includes a notched portion 4514 at one end where there is no sidewall or substantially no sidewall.

[0475] In some implementations, a projection 4508 is can also be provided. Projection 4508 can be, for example, a raised wedge, bump out, spring-loaded detent mechanism (such as a spring- loaded ball bearing) or similar assembly that forms an interference fit with the locking ring(s). Projection 4508 can be located anywhere along channel base surface 4504. In the example shown, projection 4508 is located near one end of channel base surface 4504. In some implementations, a second projection 4508 can be included and located near the other end of channel base surface 4504.

[0476] In some implementations, projection 4508 interacts with locking ring 4400, which includes an interference portion such as, for example, recess or space 4414 (Figure 44), wedge, bump or other structure for at least partially receiving or interacting with projection 4508 to form an interference fit that temporarily locks locking ring 4400 in position with respect to clasp control member 4500. In other examples, the location and arrangement of the interference fit structures (e.g., 4508 and 4414) can be reversed with respect to their locations vis-a-vis clasp control member 4500 and locking ring 4400. The exact form of interference fit or locking / unlocking structures is not critical so long as locking ring 4400 and clasp control member 4500 can be locked and unlocked with respect to each other. Further, the interference fit structures are optional and in some implementations are not included on the half rings 4400 or the clasp control member 4500.

[0477] Body 4502 further includes a connecting rod 4510 for connection to a clasp actuation line that controls the position of clasp members. In the example shown, body 4502 has an arcuate shape from which connecting rod 4510 projects. In other examples, body 4502 can have other shapes include linear and / or partially polygonal. Body 4502 also includes mounting holes 4512 for connecting a cover plate such as, for example, the cover plate shown in Figure 46.Attorney Docket No: TMTTEER-14077W001

[0478] Figure 46 shows one example of a cover plate 4600. Cover plate 4600 is connected to clasp control member 4500 and forms a second channel side wall. Cover plate 4600 includes a body 4602 having a wall 4604 that, when connected to clasp control member 4500, forms the second channel sidewall. Wall 4604 can include an optional notched portion 4608 on one end where a portion of wall 4604 has been removed. Mounting holes 4606 are provided for connecting cover plate 4600 to clasp control member 4500. Body 4602 has a generally arcuate shape, which can be made from a partially polygonal shape shown having three substantially linear or slightly arched sections (as shown in Figure 46). The exact shape of body 4602 is not critical so long as it provides a second channel sidewall for clasp control member 4500 when attached thereto.

[0479] Figures 47, 48 and 49 illustrate an example of the unlocked position or state of the slider assembly. Figure 47 shows a perspective view of an example having two clasp control member assemblies according to the examples of Figures 44-46. As shown, a round or circular arrangement is provided that, as will be described more fully, provides locking ring halves 4400a and 4400b with an arcuate or rotational movement that can lock or unlock the two control members 4500a and 4500b from each other. In the unlocked state or position, each control member 4500a and 4500b can move independently. In the locked state or position, the control members 4500a and 4500b move together.

[0480] In some implementations, movement of the locking ring halves 4400a and / or 4400b is facilitated by pushing against raised portions 4408a and / or 4408b to cause arcuate or rotational movement (either clockwise or counterclockwise) of locking ring halves 4400a and 4400b. This movement locks and unlocks the assembly. The movement occurs within a channel formed by control member 4500a and base plate 4600a and control member 4500b and base plate 4600b. A guide base 4702 is provided having guide grooves that guide the movement of control members 4500a and 4500b.

[0481] Figure 48 shows a rear view of assembly 4700. In the example shown, which is the unlocked position, the locking ring halves 4400a and 4400b are optionally held in the unlocked position by one or more of the illustrated optional projections 4508a, 4508b, 4508c, and 4508d. That is, locking ring 4400a can optionally be maintained in the unlocked position by optional projections 4508a and 4508b by being at least partially received within optional recesses in mounting aperture (e.g., 4412, not shown) in locking ring 4400a. Similarly, locking ring 4400bAttorney Docket No: TMTTEER-14077W001 can be maintained in the unlocked position by optional projections 4508c and 4508d by being at least partially received within optional recesses in mounting aperture 4412 in locking ring half 4400b. In the unlocked position or state, each clasp control member 4500a and 4500b (along with their connecting rods 4510a and 4510b) can move independently. Notched portions 4514a and 4514b can provide a clearance space so that locking members 4400a and 4400b have some positional tolerance when in the unlocked position or state.

[0482] As seen in Figure 48, in the unlocked position or state, locking ring 4400a does not interact with control member 4500b because it does not extend into the channel formed in the body of control member 4500b. As previously described, the notched portion 4514b cuts away a portion of the channel sidewall in control member 4500b thus not causing locking ring 4400a to interact therewith. Similarly, notched portion 4514a cuts away a portion of the channel sidewall in control member 4500a thus not causing locking ring 4400b to interact with control member 4500b. This allows each control member 4500a and 4500b to move independently of the other.

[0483] Figure 49 illustrates the unlocked position or state 4900 whereby each control member 4500a and 4500b can move independent of the other. Arrow 4902 illustrates that control member 4500a can move in a first direction (e.g. distally) independent of control member 4500b.Similarly, arrow 4904 illustrates that control member 4500b can move in a second direction (e.g., proximally) independent of control member 4500a. The direction of the movements can also be reversed independent of each control member.

[0484] Figures 50 and 51 show perspective and front views of the assembly in the locked position or state 5000. In the locked position or state 4900, both control members 4500a and 4500b move together. Arrow 5002 indicates movement together in a first direction (e.g., proximally) and arrow 5004 indicated movement together in a second direction (e.g., distally).

[0485] Referring now to Figure 51, locked position or state 5000 is achieved by moving either locking ring 4400a or 4400b from its unlocked position shown in e.g., Figure 48 to the position shown in Figure 51. In the locked position, movement of either locking ring 4400a or 4400b causes the other locking ring to move. This is because the end portion of locking ring halves 4400a and 4400b are positioned to contact each other such than when one moves so does the other. In the example shown, the end portions of each locking ring abut or very nearly abut each other so that movement of one locking ring causes it to come into contact with the other locking ring and to accordingly move it as well.Attorney Docket No: TMTTEER-14077W001

[0486] The movement of the locking ring can be done by pushing on raised portion 4408a and / or 4408b. This causes locking ring 4400a and 4400b to move along an arc with the channel of control member 4500a and 4500b. This action causes optional projections 4508a, 4508b, 4508c, and 4508d to be released from the optional locking ring recesses 4414, which then allow the locking ring halves to move or rotate freely. The locking ring halves 4400a and 4400b are rotated until they hit a stop and / or encounter a second set of optional projections, which then lock the locking ring halves in a second position.

[0487] For example, pushing raised portions 4408a can release locking ring 4400a from optional projections 4508a and 4508b, which can maintain locking ring 4400a in its unlocked position or state. Similarly, locking ring 4400b can move and be released from assemblies 4508c and 4508d. Each locking ring can be moved until it encounters a projection assembly on the other control member. For example, locking ring 4400a can encounter projection 4508c on control member 4500b. Control member 4500b can encounter projection 4508b on control member 4500a. This arrangement places and maintains a portion of locking member 4400a within the channel of control member 4500b and places and maintains a portion of locking ring 4400b within the channel of control member 4500a. So arranged, each of the control members 4500a and 4500b are now locked together. This locking arrangement causes control member 4500a and 4500b to move together.

[0488] Figures 52, 53, and 54 show another example of a lockable and unlockable clasp control member assembly 5200. In these figures, the clasp control members (e.g., 4500a and 4500b (Figure 45) are not shown so that the housing and locking ring halves are more visible. Figure 52 is a perspective view and Figure 54 is an exploded perspective view. Figure 53 is a sectional view taken along the section lines shown in Figure 52.

[0489] The clasp control member assembly 5200 includes first and second housings 5202 and 5204. In this example, locking ring halves 4400a and 4400b include raised portions 4408a and 4408b, respectively, at one end that include a knurled, grooved, or channeled top surface to enhance grip contact when being pushed or pulled upon. Locking ring halves 4400a and 4400b also include, on the other end, an expanded end section 5206a and 5206b, respectively, that are flanged or flared to, for example, increase their contact areas. This assists as a movement or positional stop when contacting the end walls of apertures or cutouts 5208a and 5208b.Attorney Docket No: TMTTEER-14077W001

[0490] Figure 53 shows the unlocked position or state wherein each of the locking ring halves 4400a and 4400b are within the channel of their respective clasp control member (e.g., 4500a and 4500b, respectively). As previously described, in the unlocked state, each clasp control member can move independently of the other. Thee locked position or state is achieved by pushing on raised portions 4408a and / or 4408. This moves locking ring halves 4400a and 4400b with the channel of its respective clasp control member until a portion of locking ring 4400a and 4400b is within the channel associated with the other clasp control member (e.g., sec Figure 51).

[0491] Figure 54 shows an exploded perspective view of the components of Figure 52. The channel is shown having channel side walls 5400a and 5406a and channel surface 5404a. A similarly arranged channel exists in second housing 5202. Also shown are optional projections 5408a and 5408b for creating an optional interference fit locking / unlocking arrangement with portions of the clasp control members (as previously described). The exact structure, arrangement, and location of the optional interference fit components and structures is not critical. When included, the optional interference fit components can perform the maintain and hold and release functions described herein.

[0492] In some implementations, first and second housings 5202 and 5204 and their internal channels can form a head portion of respective clasp control members. In this regard, first and second housings 5202 and 5204 can be either integrally formed into the body 4502 of respective clasp control members or attached thereto.

[0493] In operation, a clasp control member assembly is provided having locked and unlocked positions or states. Locking ring halves (4400a and 4400b) are moved between the locked and unlocked positions. The unlocked position allows each clasp control member (4500a and 4500b) to move independently of the other. To change positions or states, the locking ring halves (4400a and 4400b) are moved or slidably rotated until they reach the locked position. In this position, the clasp control members (4500a and 4500b) move together.Channels are provided or associated with the clasp control members (4500a and 4500b) that allow the locking ring halves (4400a and 4400b) to move therein between the positions or states. Holding mechanisms such as interference fit components can optionally be provided to hold and release the locking ring halves (4400a and 4400b) from each position or state.Attorney Docket No: TMTTEER-14077W001

[0494] Figures 55-63 illustrate various stages of an example deployment of an example device 8200 by the handle 3616. The handle 3616 can be used to deploy any of the devices disclosed herein, such as the repair device or treatment device 8200, 100, 200, 300, 402, 9100, etc. As shown in Figure 55, when the device 200 is in the fully open position, the externally threaded retractor 3654 is in a distal most position within the first internally threaded tube 3652, the radial flange 3698 is positioned near or adjacent the collar 3666, and the release control 3630 is positioned within the cavity 3706 of the barrel 3700.

[0495] To move the device 200 through the partially closed condition (Figure 58) and to the fully closed condition (Figure 59), the actuation element 8102 is retracted causing the paddles to move radially outward, and, in the fully closed position, be positioned alongside the clasps 8134.

[0496] To retract the actuation element 8102, the paddle actuation control 3626 is rotated, which rotates the first internally threaded tube 3652 to rotate with respect to the housing 3632, thereby driving the externally threaded retractor 3654 axially in the proximal direction, as shown in Figure 57. The axial movement of the externally threaded retractor 3654 causes axial movement of the actuation element 8102, which moves the device 8200 between the fully extended configuration (Figure 56) and the closed configuration (Figure 59).

[0497] Axial movement of the externally threaded retractor 3654 also causes axial movement of the second internally threaded tube 3708 via the link 3688. Axial movement of the second internally threaded tube 3708 causes axial movement of the release control 3630 between a position within the cavity 3706 of the barrel 3700 (shown in Figure 55) to an extended position where the release control 3630 extends proximately from the cavity 3706 of the barrel 3700 (shown in Figure 57). Accordingly, in some implementations, the axial position of the release control 3630 with respect to the housing 3632 is a visual indicator of the configuration of the device 8200.

[0498] As shown in Figure 61, the device 8200 is in the fully closed position and the outer paddles 8120 are in the expanded or widened position. In this position, as shown in Figure 60, the link 3688, the release control 3630, the second internally threaded tube 3708, and the components within the second internally threaded tube 3708 (e.g., the externally threaded drive member 3714) have moved axially such that the radial flange 3698 of the link 3688 is position within the distal end 3702 of the barrel 3700.Attorney Docket No: TMTTEER-14077W001

[0499] To move the outer paddles 8120 from the expanded position (Figure 61) to the narrowed position (as shown by arrows N in Figure 63), the width adjustment element 8211 is retracted. While Figures 60 and 62 illustrate the device 8200 in the fully closed position when the outer paddles 8120 are moved from the expanded position to the narrowed position, the outer paddles 8120 can also be moved between the expanded and narrowed positions while the device 8200 is in the fully extended position, the open position or any partially closed position. Retracting the width adjustment clement 8211 causes the inner end 8968 of the paddle frames 8224 and portions of the connector 8266 to be pulled into the actuation cap 8214 (as shown by arrow C in Figure 63).

[0500] To retract the width adjustment element 8211, the width control 3629 is rotated, which rotates the barrel 3700 and the second internally threaded tube 3708 relative to the housing 3632, thereby driving the externally threaded drive member 3714 axially in the proximal direction, as shown in Figure 62. The axial movement of the externally threaded drive member 3714 causes axial movement of the release control 3630 via the stem 3736. Since the width adjustment element 8211 is attached to the release control 3630, the axial movement of the release control 3630 causes axial movement of the width adjustment element 8211 to move the outer paddles 8120 of the device 8200 to the narrowed position. With the axial movement of the width adjustment element 8211, the annular stop 3686 moves axially within the central longitudinal passage 3683 of the externally threaded retractor 3654 (c.g., axial movement relative to the externally threaded retractor 3654).

[0501] Figure 64 illustrates an example of a device / implant catheter assembly 610 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.). In the example illustrated by Figure 64, the device / implant catheter assembly 610 can comprise an inner or actuation element 112, a coupler or capture mechanism 620, an outer shaft 611, a handle 616 (shown schematically), and clasp actuation lines 624. A proximal end portion 622a of the outer shaft 611 can be coupled to extend distally from the handle 616, and a distal end portion 622b of the outer shaft 611 can be coupled to the coupler or capture mechanism 620. The actuation element 112 can extend distally from the actuation control 626 (shown schematically in Figure 64), through the handle 616, through the outer shaft 611, and through the coupler or capture mechanism 620. The actuation element 112 can be movable (c.g., axially and / or rotationally) relative to the outer shaft 611 and the handle 616. The clasp actuation lines 624 can extend through and be axially movable relative to theAttorney Docket No: TMTTEER-14077W001 handle 616 and the outer shaft 61 1 . The clasp actuation lines 624 can also be axially movable relative to the actuation element 112.[05021 As shown in Figure 64, the actuation element 112 (e.g., actuation rod, actuation tube, actuation shaft, actuation wire, etc.) of the device / implant catheter assembly 610 can be releasably coupled to the cap 114 of the device 604. The actuation element 112 extends from a proximal end portion 112a to a distal end portion 112b. In some implementations, the distal end portion 112b of the actuation element 112 can comprise external threads configured to releasably engage interior threads of the cap 114 of the device 604. As such, rotating the actuation element 112 in a first direction (e.g., clockwise) relative to the cap 114 of the device 604 releasably secures the actuation element 112 to the cap 114, while rotating the actuation element 112 in a second direction (e.g., counterclockwise) relative to the cap 114 of the device 604 releases the actuation element 112 from the cap 114.

[0503] In the example of Figure 64, the outer shaft 611 of the device / implant catheter assembly 610 is an elongate shaft extending axially between the proximal end portion 622a, which is coupled to the handle 616, and the distal end portion 622b, which is coupled to the coupler 620. The outer shaft 611 can also include an intermediate portion 622c disposed between the proximal and distal end portions 622a, 622b. The outer shaft 611 can be formed from various materials, including metals and polymers. For example, in one particular example, the outer shaft can comprise stainless steel, polyether block amide (PEBA) and / or an outer covering or coating, such as a polymer that is reflowed over outer portions.

[0504] As shown in Figure 64, the clasp actuation lines 624 are coupled to the clasps 130a, 130b on the device 604 through holes 235 in the clasps 130a, 130b and extend axially through the outer shaft 611 between the clasps 130a, 130b and the handle 616. In some implementations, the clasp actuation lines 624 are each coupled to a clasp control member 628a, 628b at the proximal end of the clasp actuation lines 624. Each clasp control member 628a, 628b can be, for example, an axially moving control or slider coupled to a corresponding clasp actuation line 624 to axially move the clasp actuation line 624 relative to the outer shaft 611 and the actuation element 112. Each of the clasp control members 628a, 628b can be operated independently of the other clasp control member such that each clasp actuation line 624 is moved relative to the outer shaft 611, the actuation element 112, and the other clasp actuation line 624, or the clasp control membersAttorney Docket No: TMTTEER-14077W001628a, 628b can be fixed with respect to one another (e.g., locked) such that the clasp actuation lines 624 are axially moved together relative to the outer shaft 611 and the actuation element 112.[05051 In the illustrated example of Figure 64, each clasp control member 628a, 628b is movable between a first position, as shown by clasp control member 628b, and a second position, as shown by clasp control member 628a in Figure 64. The first position of each clasp control member 628a, 628b is associated with an open position of the corresponding clasp 130 and the second position is associate with a closed position of the corresponding clasp 130. For example, in the illustrated example, moving one of the clasp control members 628a, 628b to the first position pulls the corresponding clasp 130 to the open position and moving one of the clasp control members 628a, 628b to the second position releases the corresponding clasp 130 to allow the clasp to move to a closed position.

[0506] In the illustrated example of Figure 64, each clasp control member 628a, 628b is biased to the second position. Each clasp control member 628a, 628b can be biased to the second position in a variety of ways, such as springs, magnets, and elastic materials. In the illustrated example of Figure 64, each clasp control member 628a, 628b is spring-loaded. In particular, the handle 616 includes a pair of springs 627. Each spring 627 is coupled to a corresponding one of the clasp control member 628a, 628b in such a way to bias the clasp control members 628a, 628b to the second position. Each of the clasp control members 628a, 628b can further have a releasable retaining device 633, such as for example, a locking mechanism, associated with each clasp control members 628a, 628b. The releasable retaining devices 633 can be configured in any suitable manner capable of holding the corresponding clasp control member 628a, 628b in the first position against the bias of the spring 627 until being released. Each of the retaining device 633 can include a manual interface for a user to actuate in order to release the clasp control member 628a, 628b and allow the spring 627 to move the clasp control member 628a, 628b to the second position.

[0507] The clasp control member 628a, 628b can be biased to the second position with sufficient force to rapidly move the clasp control member 628a, 628b from the first position to the second position to rapidly close the clasps. In some implementations, the clasp control member 628a, 628b moves from the first position to the second position in less than 500 milliseconds (ms), less than 100 ms, less than 75 ms, or less than 50 ms.Attorney Docket No: TMTTEER-14077W001

[0508] Referring now to Figure 65, a schematically illustrated device or implant 9100 (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, a treatment device, etc.) is shown in a partially open, grasp-ready condition. The device or implant 9100 corresponds to the previously described device 100 of Figures 8-14 and the description of the device 100 applies equally to the device 9100. However, the device 9100 can be any of the valve repair devices or treatment devices disclosed herein. The device or implant 9100 is deployed from a delivery system 9102. The delivery system 9102 can comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, a device / implant catheter, a tube, a channel, a pathway, combinations of these, etc. The device or implant 9100 includes an optional coaptation portion / coaptation region 9104 and an anchor portion / anchor region 9106.

[0509] In some implementations, the coaptation portion 9104 of the device or implant 9100 includes a coaptation element 9110 (e.g., a spacer, coaptation element, plug, membrane, sheet, etc.) that is adapted to be implanted between leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and is slidable relative to an actuation element 9112 (e.g., actuation wire, actuation shaft, actuation tube, etc.).

[0510] The anchor portion 9106 includes one or more anchors 9108 that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 9112 opens and closes the anchor portion 9106 of the device 9100. The actuation element 9112 (as well as other means for actuating and actuation elements disclosed herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 9106 relative to the coaptation portion 9104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 9112 moves the anchor portion 9106 relative to the coaptation portion 9104.

[0511] The anchor portion 9106 and / or anchors of the device can take a variety of different forms. For example, the anchor portion 9106 can have any of the features of any of the anchor portions disclosed herein. In the illustrated example, the anchor portion 9106 and / or anchors of the device 9100 include outer paddles 9120 and inner paddles 9122 that are, in someAttorney Docket No: TMTTEER-14077W001 implementations, connected between a cap 91 14 and coaptation element 91 10 by portions 9124, 9126, 9128. The portions 9124, 9126, 9128 can be jointed and / or flexible to move between all of the positions described below. The interconnection of the outer paddles 9120, the inner paddles 9122, the coaptation element 9110, and the cap 9114 by the portions 9124, 9126, and 9128 can constrain the device to the positions and movements illustrated herein.

[0512] In some implementations, the delivery system 9102 includes a steerable catheter, device / implant catheter, and the actuation element 9112 (e.g., actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation element 9112 extends through a delivery catheter and to or through the coaptation element 9110. Extending and retracting the actuation element 9112 increases and decreases the spacing between the coaptation element 9110 and the distal end of the device (e.g., the cap 9114 or other attachment portion), respectively. In some implementations, a collar or other attachment element removably attaches the coaptation element 9110 to the delivery system 9102, either directly or indirectly, so that the actuation element 9112 slides through the collar' or other attachment element and, in some implementations, through a coaptation element 9110 during actuation to open and close the paddles 9120, 9122 of the anchor portion 9106 and / or anchors 9108.

[0513] In some implementations, the anchor portion 9106 and / or anchors 9108 can include attachment portions or gripping members. The gripping members can take a variety of different forms. For example, the gripping members can have any of the features of any of the gripping members disclosed herein. The illustrated gripping members can comprise clasps 9130 that include a base or fixed arm 9132, a moveable aim 9134, optional friction-enhancing elements or other securing structures 9136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 9138. The fixed arms 9132 are attached to the inner paddles 9122. In some implementations, the fixed arms 9132 are attached to the inner paddles 9122 with the joint portion 9138 disposed proximate the coaptation element 9110. The joint portion 9138 provides a spring force between the fixed and moveable arms 9132, 9134 of the clasp 9130. The joint portion 9138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 9138 is a flexible piece of material integrally formed with the fixed and moveable arms 9132, 9134. The fixed arms 9132 are attached to the inner paddles 9122 and remain stationary or substantially stationary relative to theAttorney Docket No: TMTTEER-14077W001 inner paddles 9122 when the moveable arms 9134 are opened to open the clasps 9130 and expose the optional barbs, friction-enhancing elements, or securing structures 9136.[05141 In some implementations, the clasps 9130 are opened by applying tension to actuation lines 9116 attached to the moveable arms 9134, thereby causing the moveable arms 9134 to articulate, flex, or pivot on the joint portions 9138. The actuation lines 9116 extend through the delivery system 9102 (e.g., through a steerable catheter and / or a device / implant catheter). Other actuation mechanisms are also possible.

[0515] The actuation lines 9116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps 9130 can be spring loaded so that in the closed position the clasps 9130 continue to provide a pinching force on the grasped native leaflet. Optional barbs, friction-enhancing elements, or securing structures 9136 of the clasps 9130 can grab, pinch, and / or pierce the native leaflets to further secure the native leaflets.

[0516] During implantation, the paddles 9120, 9122 can be opened and closed, for example, to press the native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles 9120, 9122 and / or between the paddles 9120, 9122 and the coaptation clement 9110 (e.g., a spacer, plug, membrane, gap filler, etc.). The clasps 9130 can be used to grasp and / or further secure the native leaflets by engaging the leaflets with optional barbs, friction-enhancing elements, or securing structures 9136 and pinching the leaflets between the fixed and moveable arms 9132, 9134. The optional barbs or other friction-enhancing elements 9136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps 9130 increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines 9116 can be actuated separately so that each clasp 9130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 9130 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps 9130 can be opened and closed relative to the position of the inner paddle 9122 (if the inner paddle is in an open or at least partially open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.

[0517] In Figure 65, the device 9100 is shown in a partially open, grasp-ready condition with the clasps 9130 in a fully open position such that the moveable arms 9134 of the clasps 9130 are in contact with an outer surface 9135 of the coaptation element 9110. Referring to Figure 66, the device 9100 is shown in the partially open, grasp-ready condition but the clasps 9130 are in aAttorney Docket No: TMTTEER-14077W001 drooped position. The drooped position is an undesired clasp position that can occur in some devices. In the drooped position, the clasps 9130 are actuated to be in the fully open position shown in Figure 65, but instead of being in, or remaining in, the fully open position, the moveable arms 9134 are positioned, or prematurely move, away from the outer surface of the coaptation element 9110 (e.g., the angle between the fixed arm 9132 and the movable arm 9134 is less in the drooped position than in the fully open position). In the drooped position, there can be slack in the actuation lines 9116 such that the actuation lines 9116 do not hold the clasps 9130 in the fully open position. The clasps 9130 can be positioned at, or prematurely lower to, the drooped position if, for example, the actuation element 9112 stretches during implant elongation, the implant elongation length setting procedure is incorrect, or the length of the actuation lines 9116 is incorrect.

[0518] Referring to Figure 67, the device 9100 is shown in an elongated condition with the clasps 9130 in a fully open position (e.g., approximately 180 degrees between fixed and moveable arms 9132, 9134 of the clasps 9130). Figure 68 illustrates that the clasps 9130 can be in a drooped position when the device 9100 is also in the elongated condition. As shown in Figure 68, instead of being in the fully open position, the moveable arms 9134 are positioned or move away from the coaptation element 9110 (e.g., the angle between the fixed arm 9132 and the movable arm 9134 is less in the drooped position than in the fully open position).

[0519] Figure 69 is a schematic illustration of an example device / implant catheter assembly 9610 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) configured to compensate for clasp droop. The device / implant catheter assembly can take a variety of different forms. For example, the device / implant catheter assembly can have any of the features of any of the device / implant catheter assemblies disclosed herein. In the illustrated example, the device / implant catheter assembly 9610 corresponds to the previously disclosed device / implant catheter assembly 610 and the description of the device / implant catheter assembly 9610 applies equally to the device / implant catheter assembly 9610. The device / implant catheter assembly 9610 can include any feature for a device / implant catheter assembly 9610 discussed in the present application or the applications cited above.

[0520] In the example illustrated by Figure 68, the device / implant catheter assembly 9610 can comprise an inner or actuation element 9112, a coupler or capture mechanism 9620, an outerAttorney Docket No: TMTTEER-14077W001 shaft 9611 , a handle 9616 (shown schematically), and clasp actuation elements 9624 (e.g., clasp actuation line, clasp actuation wire, clasp actuation shaft, clasp actuation rod, clasp actuation tube, etc.). A proximal end portion 9622a of the outer shaft 9611 can be coupled to extend distally from the handle 9616, and a distal end portion 9622b of the outer shaft 9611 can be coupled to the coupler or capture mechanism 9620. The actuation element 9112 can extend distally from an actuation control 9626 (shown schematically in Figure 69), through the handle 9616, through the outer shaft 9611, and through the coupler or capture mechanism 9620. The actuation element 9112 can be movable (e.g., axially and / or rotationally) relative to the outer shaft 9611 and the handle 9616. The clasp actuation elements 9624 can extend through and be axially movable relative to the handle 9616 and the outer shaft 9611. The clasp actuation elements 9624 can also be axially movable relative to the actuation element 9112.

[0521] As shown in Figure 69, the actuation element 9112 (e.g., actuation rod, actuation tube, actuation shaft, actuation wire, etc.) of the device / implant catheter assembly 9610 can be releasably coupled to the cap 9114 of the device 9604, either directly or through one or more intermediate components. The actuation element 9112 extends from a proximal end portion 9112a to a distal end portion 9112b. In some implementations, the distal end portion 9112b of the actuation element 9112 can comprise external threads configured to releasably engage interior threads of the cap 9114 or an intermediate component of the device 9604. As such, rotating the actuation element 9112 in a first direction (e.g., clockwise) relative to the cap 9114 of the device 9604 releasably secures the actuation element 9112 to the cap 9114 or intermediate component, while rotating the actuation element 9112 in a second direction (e.g., counterclockwise) relative to the cap 9114 of the device 9604 releases the actuation element 9112 from the cap 9114 or intermediate component. However, the actuation element 9112 can be coupled to the cap or intermediate component in a wide variety of different ways. For example, the actuation element can be coupled to the cap or intermediate component in any manner that any of the actuation elements disclosed in this application are coupled.

[0522] In the example of Figure 69, the outer shaft 9611 of the device / implant catheter assembly 9610 is an elongate shaft extending axially between the proximal end portion 9622a, which is coupled to the handle 9616, and the distal end portion 9622b, which is coupled to the coupler 9620. The outer shaft 9611 can also include an intermediate portion 9622c disposed between the proximal and distal end portions 9622a, 9622b. The outer shaft 9611 can be formed from various materials, including metals and polymers. In some implementations, the outer shaft can compriseAttorney Docket No: TMTTEER-14077W001 stainless steel, polyether block amide (PEBA) and / or an outer covering or coating, such as a polymer that is reflowed over outer portions.[05231 As shown in Figure 69, the clasp actuation elements 9624 are coupled to the clasps 9130a, 9130b on the device 9604 through holes 9235 in the clasps 9130a, 9130b and extend axially through the outer shaft 9611 between the clasps 9130a, 9130b and the handle 9616. In some implementations, the clasp actuation elements 9624 are each coupled to a clasp control member 9628a, 9628b at the proximal end of the clasp actuation elements 9624. Each clasp control member 9628a, 9628b can be, for example, an axially moving control or slider coupled to a corresponding clasp actuation element 9624 to axially move the clasp actuation element 9624 relative to the outer shaft 9611 and the actuation element 9112. Each of the clasp control members 9628a, 9628b can be operated independently of the other clasp control member such that each clasp actuation element 9624 is moved relative to the outer shaft 9611, the actuation element 9112, and the other clasp actuation element 9624, or the clasp control members 9628a, 9628b can be fixed with respect to one another (e.g., locked) such that the clasp actuation elements 9624 are axially moved together relative to the outer shaft 9611 and the actuation element 9112.

[0524] In the illustrated example of Figure 69, each clasp control member 9628a, 9628b is moveable proximally to a first position to pull the corresponding clasp 9130a, 9130b to the open position and distally to a second position to release the corresponding clasp 9130a, 9130b to allow the clasp to move to a closed position. In the illustrated example of Figure 69, the handle 9616 includes a droop compensation mechanism 9630 configured to prevent or reduce drooping of the clasps 9130a, 9130b. The droop compensation mechanism 9630 can prevent or reduce clasp droop in a variety of ways.

[0525] In the illustrated example of Figure 69, the droop compensation mechanism 9630 includes one or more biasing elements 9632 configured to apply a force to each of the clasp actuation elements 9624, to each of the clasp control members 9628a, 9628b, or to both, such that the clasp actuation elements 9624 move the clasps 9130a, 9130b to the fully open position. For example, in some implementations, the one or more biasing elements 9632 can engage each of the clasp actuation elements 9624 and / or clasp control member 9628a, 9628b to cause each of the clasp actuation elements 9624 to pull the clasps 9130a, 9130b from the drooped position to the fully open position.Attorney Docket No: TMTTEER-14077W001

[0526] In some implementations, the one or more biasing elements 9632 are configured to remove slack from the clasp actuation elements 9624 (e.g., when the clasp actuation elements 9624 are configured as suture lines). The one or more biasing elements 9632 can be configured to apply the force during movement of the clasp control members 9628a, 9628b from the second position to the first position and after the clasp control members 9628a, 9628b are in the fully proximal first position. Thus, even when the clasp control members 9628a, 9628b have reached the fully proximal first position (c.g., the clasp control members cannot further pull on the clasp actuation elements 9624 to move the clasps), the one or more biasing elements 9632 continue to apply a force to pull the first clasp toward the open position. For example, the one or more biasing elements 9632 can be configured to take-up (e.g., elastically stretch and return to its original length) a distance that is greater than or equal to an anticipated maximum clasp droop. For example, the one or more biasing elements 9632 can be configured to take-up 0.1mm to 10mm of droop, such as 0.2-5mm of droop, such as 0.3-2mm of droop, or any subrange of these ranges.

[0527] The one or more biasing elements 9632 can be configured in a variety of ways. In some examples, the one or more biasing elements 9632 can be springs, elastic elements capable of applying a suitable force to the clasp actuation elements 9624 and / or clasp control member 9628a, 9628b, elastic portion(s) of the clasp actuation elements 9624, clasp actuation elements 9624 made entirely of an clastic material, a clasp control member 9628a and / or 9628b having a spring or elastic element, etc. In some examples, the droop compensation mechanism 9630 can correct droop in one clasp 9130a independent of the other clasp 9130b (e.g., can move the clasp actuation element and / or clasp control member associated with one clasp independently from the clasp actuation control and / or clasp actuation element associated with the other clasp).

[0528] Figure 70 is a schematic illustration of an example device / implant catheter assembly 9710 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) configured to compensate for clasp droop. The device / implant catheter assembly 9710 corresponds to the previously disclosed device / implant catheter assembly 9610 and the description of the device / implant catheter assembly 9610 applies equally to the device / implant catheter assembly 9710 with reference numbers of like elements kept the same. The device / implant catheter assembly 9710 can include any feature of any device / implant catheter assembly discussed in the present application or the applications cited above. In the example illustrated by Figure 70, the droop compensationAttorney Docket No: TMTTEER-14077W001 mechanism 9630 incorporates the one or more biasing elements 9632 as part of each of the clasp actuation elements 9624.[05291 In some examples, each clasp actuation element 9624 can be made to be elastic, along the entire clasp actuation element 9624 or along one or more sections of the clasp actuation element 9624. For example, an entire elastic clasp actuation line or an elastic portion of a clasp actuation line can be configured to take-up (e.g., elastically stretch and return to its original length) a distance that is greater than or equal to an anticipated maximum clasp droop. For example, an entire elastic clasp actuation line or an elastic portion of a clasp actuation line can be configured to take-up 0.1mm to 10mm of droop, such as 0.2-5mm of droop, such as 0.3mm-2mm of droop, or any subrange of these ranges. The elastic clasp actuation element 9624, or portions thereof, can function as the one or more biasing elements 9632. For example, each clasp actuation element 9624 can include a portion near or adjacent each corresponding clasp control member 9628a, 9628b within the handle 9616 that functions as a biasing element 9632. The elastic portion or portions of the clasp actuation element 9624 can, however, be located along the clasp actuation element 9624 at any suitable location.

[0530] The clasp actuation element 9624, when configured as a suture line in some examples, can be made as a braided suture line. To increase the elasticity of the braided suture line or a portion of the suture line, the suture line or elastic portion of the suture line can be made with higher picks per inch of current suture material or from elastic materials. In some examples, one or more biasing elements 9632 can be separate elements from the clasp actuation element 9624 but attached inline. For example, the biasing elements 9632 can be springs or other suitable elastic elements that are separate from, but attached in-line with, the clasp actuation element 9624. The biasing elements 9632 can attach in-line with the clasp actuation element 9624 in any suitable manner. For example, a spring or elastic element can have suture lines attached to either end of the spring or elastic element with the combined spring / elastic element and suture lines functioning as the clasp actuation element 9624.

[0531] An example method of utilizing the elastic clasp actuation elements 9624 in the device / implant catheter assembly 9710 can include setting or selecting a length of the elastic clasp actuation elements 9624 when the device 9604 is in the fully elongated position, as shown in Figure 67 and the clasp control members 9628a, 9628b are in a fully forward position, as shown in Figure 71 (e.g., the clasps are in the first closed or fully forward position). ThisAttorney Docket No: TMTTEER-14077W001 provides the minimum length of the clasp actuation element 9624 required to allow the clasps to move to the fully forward position at the fully elongated configuration. Thus, the biasing elements 9632 are in a non-stretched or natural condition so that little or no tension is applied to the clasps so that the clasps can move to the closed position without interference. When the clasp control members 9628a, 9628b are retracted to move the clasps up against the coaptation element 9110, the travel of the clasp control members can be configured to be greater than the travel when not using the biasing elements 9632. In this way, the biasing elements 9632 are stretched, which provides a pulling force on the clasps. As a result, if conditions that can result in clasp droop are present, the pulling force of the stretched biasing elements 9632 pulls the clasps to the fully open position.

[0532] Figures 71-72 illustrate an example clasp actuation portion 9831 of a handle 9816 of a device / implant catheter assembly 9810 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.). The clasp actuation portion 9831 corresponds to the previously disclosed clasp actuation portion 3631 of the handle 3616 and the description of the clasp actuation portion 3631 applies equally to the clasp actuation portion 9831. The clasp actuation portion 9831 can include any feature of any clasp actuation portion of any handle discussed in the present application or the applications cited above.

[0533] The clasp actuation portion 9831 can include first and second clasp control members 9828a, 9828b which are configured to move the clasps (e.g., clasps 9130 of device 9100) of the device via clasp actuation elements 9824. The clasps can be configured in the same manner as any of the clasps described herein. The clasp actuation portion 9831 can be configured in a variety of ways. In some implementations, the device / implant catheter assembly 9810 includes two clasp actuation elements 9824 each coupled to a corresponding clasp control member 9828a, 9828b at the proximal end of the clasp actuation elements 9824. For ease of illustration, only one clasp actuation element 9824 is shown in Figure 71. In the illustrated example, the clasp actuation element 9824 is configured as a clasp actuation line. In some implementations, the clasp actuation element 9824 can be configured as a clasp actuation wire, a clasp actuation shaft, a clasp actuation rod, a clasp actuation tube, etc.

[0534] Each clasp control member 9828a, 9828b can be, for example, an axially-moving control or slider coupled to a corresponding clasp actuation element 9824 to axially move the claspAttorney Docket No: TMTTEER-14077W001 actuation element 9824 relative to the actuation element 8102. Each of the clasp control members 9828a, 9828b can be operated independently of the other clasp control member such that each clasp actuation element 9824 is moved relative to the actuation element 8102 and the other clasp actuation element 9824. The clasp control members 9828a, 9828b can also be fixed with respect to one another (e.g., locked) such that the clasp actuation elements 9824 are axially moved together relative to the actuation element 8102.

[0535] The clasp control members 9828a, 9828b can be configured in a variety of ways, including similar to any clasp control member disclosed herein. In the implementation depicted in Figures 71-72, the clasp control members 9828a, 9828b are similar to the clasp control members 3628 of Figures 42-43, and thus the previous description of the clasp control members 628 applies equally to the clasp control members 9828a, 9828b shown in Figures 71-72. The handle 9816 includes a first and second line-engaging member 9833a, 9833b configured to engage the clasp actuation elements 9824 to move the elements in response to movement of the clasp control members 9828a, 9828b. The line-engaging members 9833a, 9833b can be configured in a variety of ways. In the illustrated example, each line-engaging member 9833a, 9833b is configured as an elongated projection having a proximal end fixed to a corresponding clasp control member 9828a, 9828b and a distal end configured to engage a corresponding clasp actuation element 9824. In the illustrated example, the distal end of each line-engaging member 9833a, 9833b includes a passage 9837 through which a clasp actuation element 9824 can extend.

[0536] The handle 9816 includes a housing 9834 having a distal stem 9836 defining a passage 9838, a main body portion 9840 defining an interior space 9842, and a proximal cap 9844 through which the actuation element 8102 extends. In addition, each of the line-engaging members 9833a, 9833b extend distally from the respective clasp control members 9828a, 9828b through the proximal cap 9844 and into the interior space 9842. The main body portion 9840 further includes a line anchor, similar to line anchor 3748 of Figures 42-43, to which the proximal ends of the clasp actuation elements 3624 attach.

[0537] In the example illustrated by Figure 71-72, the clasp actuation portion 9831 includes a droop compensation mechanism 9830 configured to prevent or reduce drooping of the clasps of a device or implant. The droop compensation mechanism 9830 has features of the previously disclosed droop compensation mechanism of the release control 3630 of Figure 70 and the description of the compensation mechanism of the release control 3630 applies to the droopAttorney Docket No: TMTTEER-14077W001 compensation mechanism 9830. The droop compensation mechanism 9830 can include any feature of any droop compensation mechanism discussed in the present application.[05381 In the illustrated example of Figures 71-72, the droop compensation mechanism 9830 includes a first biasing element 9832a and a second biasing element 9832b configured to apply a force to a corresponding clasp actuation element 9824 such that the clasp actuation elements 9624 move the clasps to the fully open position if conditions that can result in clasp droop are present. The biasing elements 9832a, 9832b can be configured in a variety of ways. In the illustrated example, the first biasing element 9832a is associated with the first clasp control member 9828a and the second biasing element 9832b is associated with the second clasp control member 9828b.

[0539] In the example illustrated by Figures 71 and 72, the first biasing element 9832a has an elongated body 9850 having a proximal end 9852 and a free distal end 9854. The proximal end 9852 is fixed relative to the housing 9834. For example, the proximal end 9852 can be fixedly attached to the proximal cap 9844 or another suitable portion of the handle 9816. The elongated body 9850 has an outward bowed or semi-elliptical shape resembling a band or leaf (e.g., a thin body with generally parallel inner and outer faces). A slot or opening 9856 can extend along a portion of the elongated body 9850 through which the corresponding clasp actuation element 9824 extends. In some examples, the slot or opening 9856 is positioned in a distal portion, such as a distal half, of the elongated body 9850. In some examples, the slot or opening 9856 extends along a majority of the distal half of the elongated body 9850.

[0540] The second biasing element 9832b can be identical to the first biasing element 9832a and arranged in mirror image to the first biasing element 9832a about a central longitudinal axis Z. Thus, the description of the first biasing element 9832a applies equally to the second biasing element 9832b. The biasing elements 9832a, 9832b are configured to be biased outward away from each other to a wide first position, as shown in Figure 72.

[0541] Each clasp control member 9828a, 9828b is moveable between a first position (e.g., fully proximal), as shown in Figure 72, and a second position (e.g., fully distal), as shown in Figure 71. The first position of each clasp control member 9828a, 9828b is associated with an open position of the corresponding clasp (e.g., the clasp position shown in Figures 65 and 67) and the second position is associated with a closed position of the corresponding clasp (e.g., the clasp position shown in Figure 8). For example, in the illustrated example, moving one of the claspAttorney Docket No: TMTTEER-14077W001 control members 9828a, 9828b to the first position pulls the corresponding clasp to the open position and moving one of the clasp control members 9828a, 9828b to the second position releases the corresponding clasp to allow the clasp to move to a closed position.

[0542] As shown in Figure 71, when the clasp control members 9828a, 9828b are in the second position, each of the first and second line-engaging members 9833a, 9833b extends outward of and along a length of the respective first and second biasing elements 9832a, 9832b to engage and move the distal ends 9854 of the first and second biasing elements 9832a, 9832b toward each other such that the first and second biasing elements 9832a, 9832b are in the narrow second position, as shown in Figure 71. In the narrow second position, the clasp actuation elements 9824 extend through the openings 9856 without the first and second biasing elements 9832a, 9832b applying any force onto the clasp actuation elements 9824. Thus, the clasps can close without disruption from any force from the first and second biasing elements 9832a, 9832b being applied to the clasp actuation elements 9824.

[0543] As shown in Figure 72, when the clasp control members 9828a, 9828b are in the first position, the first and second line-engaging members 9833a, 9833b are retracted and do not engage the first and second biasing elements 9832a, 9832b. In addition, a portion of the clasp actuation elements 9824 are pulled by the first and second line-engaging members 9833a, 9833b to be along and outward of the first and second biasing elements 9832a, 9832b. With the clasp control members 9828a, 9828b retracted, the first and second biasing elements 9832a, 9832b are free to expand outward to the wide first position. When expanding outward toward the wide position, the first and second biasing elements 9832a, 9832b engage (e.g., an outer face of each biasing members can contact a corresponding clasp actuation elements) and apply a force to the clasp actuation elements 9824. The outward force applied to the clasp actuation elements 9824 by the first and second biasing elements 9832a, 9832b can take up any slack in the clasp actuation elements 9824 and cause the clasp actuation elements 9824 to pull the clasps to the fully open position, thus eliminating or reducing any droop in the clasp.

[0544] Depending on the amount of slack in the clasp actuation elements 9824, the first and second biasing elements 9832a, 9832b can expand to a position less than the wide first position (e.g., once all slack has been removed, the clasp actuation elements 9824 can prevent or inhibit the first and second biasing elements 9832a, 9832b from fully expanding). The first clasp control member 9828a and associated first biasing element 9832a can work independent of the secondAttorney Docket No: TMTTEER-14077W001 clasp control member 9828b and associated second biasing element 9832b. Thus, droop in one clasp can be addressed independent of droop in the other clasp. Further, if clasp droop is asymmetric (e.g., one clasp droops more than the other clasp), since each biasing element 9832a, 9832b is independent of the other, each biasing member can correct and compensate for the amount of droop present in the clasp associated with the biasing member.

[0545] Figures 73, 74 and 75 schematically illustrate an example of slack control 7300 for one or more clasp actuation lines. In some implementations, a tensioner or bias member such as, for example, one or more coil springs, are provided to take up slack that may develop in a clasp actuation line.

[0546] Figure 73 schematically represents the situation when the clasp member is in the down or closed configuration. Some implementations include clasp control member 628, clasp actuation line 624, and a bias member or tensioner 7302. In the clasp down position, there is substantially no stretch or slack in clasp actuation line 624.

[0547] Figure 74 schematically represents the situation 7400 when the clasp member has been moved from the closed to the open configuration and is, for example, leaflet capture ready. In this open position, clasp control member 628 has been retracted to cause the positional change relative to 7300. Also in this scenario, bias member or tensioner 7302 will be engaged (e.g., by extension) to balance the retraction force against the clasp actuation force necessary to move the clasp. Bias member 7302 in effect controls or reduces the stretch or tensile force acting on clasp actuation lines 624 as a result of these movements by elongating under spring force. This maintains the tautness of clasp actuation line 624 and reduces or eliminates any stretch of the clasp actuation line and resulting droop that may occur.

[0548] Figure 75 schematically represents the situation 7500 when the clasp member has been moved back to the closed configuration but the catheter leading to the clasps has bent and / or elongated. This will increase the length of clasp actuation line 624 needed for the clasp to move to the closed position. In this scenario, bias member or tensioner 7302 will be engaged (e.g., by extension) to reduce and / or eliminate the force acting on clasp actuation line 624 to prevent stretching of the clasp actuation line. That is, the spring stretches instead of the clasp actuation line 624. This maintains the tautness of clasp actuation line 624 in the open position and reduces or eliminates any stretch of the clasp actuation line and any resulting clasp droop that may occur.Attorney Docket No: TMTTEER-14077W001

[0549] Figures 76, 77, and 78 show an example of slack control for one or more clasp actuation lines. Figure 76 schematically represents the situation when the clasp member is in the down / closed configuration and the paddles are in the elongated or initial delivery configuration. The example 7600 includes clasp control member 628, clasp actuation line 624, and a bias member 7612.

[0550] In some implementations, clasp control member 628 includes a body having a chamber 7602 that includes a first chamber section 7604 and a second chamber section 7606. A connecting rod having a head portion 7608 connected to a rod portion 7610 is disposed in chamber 7602, along with biasing member 7612. In some implementations, head portion 7608 includes a bearing surface 7614 for contacting one end of biasing member 7612, which can be a compression coil spring or equivalent device / structure. In some implementations, the chamber 7602 can include a second bearing surface for contacting the other end of biasing member 7612. In some implementations, the second bearing surface 7616 can include a section of the wall(s) dividing chamber 7602 into first chamber section 7604 and second chamber section 7606. So arranged, biasing member 7612 is disposed in chamber 7602 and between bearing surface 7614 and second bearing surface 7616.

[0551] As will be described in more detail, biasing member 7612 compresses and decompresses within first chamber section 7604 to control and / or reduce the tension force acting on clasp actuation line 624. This, in return, maintains the tautness of clasp actuation line 624 as it is used to position the clasp, or is subject to stretching forces caused by bending and / or stretching of the delivery tubes or catheters used for device implantation.

[0552] Figure 76 illustrates the initial delivery or closed position of the clasp (e.g., 9130a and / or 9130b) and paddles. As shown in the figure, biasing member 7612 is configured to be in the rest position (e.g., not compressed along the direction of arrow 7618.

[0553] Figure 77 illustrates movement of the clasps (9130a and 9130b) to the open or capture ready position with the paddles also moved to the capture ready position. The clasps are moved to this position by moving clasp control member 628 in the direction of arrow 7620. The force required to move the clasps will be translated to connecting rod portion 7610 and head portion 7608 by clasp actuation line 624. This force will cause movement of rod portion 7610 and biasing member 7612 to thereby compress biasing member 7612 between bearing surfaces 7614Attorney Docket No: TMTTEER-14077W001 and 7616. If there is slack or droop in clasp actuation line 624, biasing member 7612 can (slightly) uncompress from the position shown in Figure 77 to take up the slack or droop and maintain tautness.

[0554] Figure 78 illustrates the scenario where the clasps are in the open configuration and the paddles are in the extended position. This configuration can be used to release the device from native tissue, such as leaflet tissue, chorded tendinea, etc. The movement of clasp control member 628 in the direction of arrow 7800 places the clasp (9130a) in the open or tissue release position and has caused some compression of biasing member 7612 (as described above). In the case where the delivery tube(s) may have experienced elongation or stretch, and imparted such force on clasp actuation line 624, biasing member 7612 can compress further to relieve some or all of that force. This again assists in reducing or preventing stretch or droop which may occur in clasp actuation line 624 by these forces.

[0555] Figures 79, 80, and 81 illustrate another example 7900 of a clasp control assembly having slack or droop compensation. In this example, the slack or droop compensation can be included into clasp control member (e.g., 4500a and 4500b). Figure 79 shows a side view of the example having first and second housings 5202 and 5204 (e.g., see Figure 52) that house first and second clasp control members, from which their connecting rods 4510a and 4510b extend.

[0556] Figure 81 is a sectional view taken along the section lines shown in Figure 80, which is a left side view of the example. In this section view, clasp control member 628a and 628b are similarly constructed and include chamber 7602a and 7602b, respectively. Each chamber 7602a and 7602b includes first chamber sections 7604a and 7604b and second chamber sections 7606a and 7606b. Chambers 7602a and 7602b include connecting rods having head portions 7608a and 7608b and rod portions 7610a and 7610b, respectively. First bearing surfaces 7614a and 7614b and second bearing surfaces 7616a and 7616b are provided. Between these bearing surfaces, biasing members 7612a and 7612b are positioned, as shown. Thus, construction mirrors the arrangement shown in Figures 76-78 and mirrors the operation described as well, which is hereby incorporated by reference herein.

[0557] In some implementations, biasing member 7612 and the size of chamber 7602 should be selected with the expected amount of slack or droop in clasp actuation line 624 for at least these scenarios, or more in the case of using a safety factor. Thus, the amount of compression and decompression for biasing member 7612 under these circumstances should be taken into accountAttorney Docket No: TMTTEER-14077W001 when sizing chamber 7602 to allow biasing member 7612 to compress and decompress within chamber 7602 when required. While biasing member 7612 has been described as a compression coil spring, any suitable spring or biasing member, element, or assembly that behaves similarly can be used including, for example, leaf springs and elastomeric members.

[0558] As shown in Figures 79, 80, and 81, slack or droop compensation for clasp actuation lines (e.g., 624) is provided by a biasing member (e.g., 7612) in association with a connecting rod (e.g., 4510) structure. The connecting rod structure compresses and decompresses the biasing member as the clasp actuation line experience varying degrees of tension forces, which can otherwise cause slack or droop in the clasp actuation lines. When the clasp actuation lines experience excessive tension forces, the biasing member can compress to relieve some or all of the forces. When the tension forces lessen, the biasing member can decompress to account for the lessened force. Thus, the biasing member reduces the tension forces on the clasp actuation line and also compensates for any slack and resulting droop caused by these forces by maintaining the tautness of the clasp actuation line.

[0559] Referring now to Figure 82, an example of a multiple lumen catheter assembly 8280 is made of a metal coil material. The multiple lumen catheter assembly 8280 can be used in a variety of different applications. In some implementations, the catheter assembly 8280 can be used as the implant catheter for implanting any of the devices disclosed herein. Some implementations include a central tube 8282 and side tubes 8284, 8286, 8288, and 8290. In one example, each tube is made of a metal coil material. The metal coil material can take a variety of different forms and the different coils can be made from different materials. In some implementations, the metal coil material can be a coiled wire and / or a spiral cut tube, such as a spiral laser cut hypotube. When made from a wire, the metal coil material can be made from a flat wire or a round wire.

[0560] In some implementations, central tube 8282 is made of a metal coil material 8292 and side tubes 8284, 8286, 8288, and 8290 are made from metal coil materials 8294, 8296, 8298, and 8299, respectively. The metal coil materials need not be of the same construction of materials. For example, metal coil material 8292 of the central tube 8282 may be made of a thicker or stronger material to improve stiffness and robust tensile strength for the overall assembly. So formed, side tubes 8284, 8286, 8288, and 8290 can be connected in one or more places to central tube 8282 such as by, for example, welding, soldering, adhesives, etc. to form the overallAttorney Docket No: TMTTEER-14077W001 assembly. Each of the tubes can carry within them structures for one or more of the following functions: implant elongation, implant closure, implant rotation, and clasp actuation / control, etc. and combinations thereof.

[0561] In some implementations, the assembly 8280 can be made from a single continuous metal coil material, instead of separate metal coil materials. In this example, the single coil material can begin by coiling one coil of a first side tube (e.g., 8294), then one coil of a spaced second side tube (e.g., 8286), then one coil of a spaced third side tube (e.g., 8288), and then one coil of a spaced fourth side tube (e.g., 8299), and then returning to the first side tube (e.g., 8294) to complete a second coil, and so one. The center coil 8292 is formed as the coil material is moved to the four outer coils. In this manner, the 5 tubes shown in Figure 82 can be constructed of a single continuous metal coil material. The metal coil material can be made from metal such as, for example, stainless steel, Nitinol, titanium, etc. The metal coil material can be a round or flat strip of material having one or more bends of any appropriate configuration to allow for a flexible metal coil tube that can bend and return to its original position.

[0562] Figure 83 illustrates one example 8300 wherein the multiple tubes of Figure 82 are within a catheter system 8302 having an optional outer sheathing or outer tube 8304 provided with an optional coupler 8306. The outer tube can take a variety of different forms. For example, the outer tube 8304 can be made from a plastic material, a metal material, and / or can comprise a coil and / or a braid. The coupler can take a wide variety of different forms. For example, the coupler can be configured to couple with and release any of the valve repair devices disclosed herein and / or can be any of the couplers disclosed herein. Figure 84 is a sectional view taken along section line C-C in Figure 83. At this section, catheter system 8302 includes central tube 8282 and side tubes 8284, 8286, 8288, and 8290, which are spaced about 90 degrees apart.

[0563] In some implementations, spacers 8402 can be provided between side tubes 8284, 8286, 8288, and 8290 to orient and / or maintain the side tubes in position. Spacer 8402 can be made of any suitable material including polymer(s) and / or metal(s) and can be solid (e.g., as shown or, alternatively, for example, rod-like) or hollow (e.g., having an outer wall and a hollow inner space). In the case of spacers 8402 being hollow, they can resemble mandrels, tubes or tube-like arrangements, which can function as lumens. Thus, the spacers 8402 can perform an alignment function with respect to, for example, aligning and positioning the side tubes, but also act as additional tubes or lumens themselves.Attorney Docket No: TMTTEER-14077W001

[0564] Figure 85 is a sectional view taken along section line D-D in Figure 83. At this section, catheter system 8302 includes central tube 8282 and side tubes 8284, 8286, 8288, and 8290. However, there are no spacers 8402 between the side tubes. Instead, open spaces 8502 are provided. In some implementations, there can also be spacers 8402 in that location.

[0565] Figure 86 illustrates an example 8600 of the system having a proximal section 8602 and distal section 8604 (with coupler 8306). Outer tube (e.g., 8304) in each of these sections can have a different arrangement / compo sition. For example, proximal section 8602 can include an outer tube (e.g., 8304) comprising an interrupted spiral laser cut pattern (e.g., see Figure 87 and related text), which controls the flexibility and / or rigidity of the outer tube. In some examples, the interrupted spiral laser cut pattern can transition from a low to a high pitch rate as it approaches the distal section 8604 such that the pitch rate along the length of the proximal section varies. In some implementations, distal section 8604 can maintain the high pitch rate (for flexibility) or can have a different or modified pitch rate to customize or establish its own flexibility characteristic.

[0566] In some implementations, proximal section 8602 can be made of a metal tube such as, for example, a stainless steel hypotube or similar material / structure. In some implementations, distal section 8604 (and coupler 8306) can be made of a similar or different material including, for example, Nitinol. In some implementations, a region of flexibility can be formed at the interface between proximal section 8602 and distal section 8604.

[0567] Figure 87 illustrates an example 8700 of an interrupted spiral laser cut pattern 8702 on outer tube 8304 and / or one or more of the tubes 8204, 8206, 8208, 8210 (when made from tubes). The general pattern can include several specifications including, for example, pitch distance DI, kerf width D2, cut length or degree length D3, and uncut length or degree length D4. As previously described, each of these parameters can be varied to form one or more laser cut patterns in outer tube 8304, which impact the flexibility and strength of outer tube outer tube 8304.

[0568] Figure 88 illustrates a partial perspective view with portions of outer tube 8304 removed for clarity. In this example 8800, spacers 8402 do not extend through the entire length of the catheter system, but only partially. For example, spacers 8402 can be used where necessary to maintain the position of the tubes. In other examples, they can extend any distance from theAttorney Docket No: TMTTEER-14077W001 beginning to the end of the catheter system and distances therebetween. This includes, for example, only at the beginning and / or end of the catheter system.

[0569] Figure 89 illustrates an end view of an example 8900 having a four outer lumen configuration with lumens or tubes 8284, 8286, 8288, 8290 made according to any of the implementations or examples disclosed herein.

[0570] Figure 90 illustrates an end view of an example 9000 having a two outer lumen configuration with lumens or tubes 8286 and 8290 made according to any of the implementations or examples disclosed herein. In this example, even though there are no third or fourth individual lumens, the spaces between lumens or tubes 8286 and 8290 is further bound by outer tube 8304 and central tube 8282 so as to create lumen-like spaces 9002 and 9004 that can act as individual lumens in this arrangement. The lumen-like spaces 9002 and 9004 can carry any structure or devices (including sensors) therein that typical lumens can carry. Lumen-like spaces 9002 and 9004 can be any shape and do not have to be the same shape or size. One can be larger or smaller than the other and can be of different shapes.

[0571] So arranged, an all or partial metal lumen catheter system is provided. The system can be arranged with multiple lumens and / or lumen-like spaces to facilitate device implantation. The lumens can be constructed of a single continuous metal coil material or individual metal coil materials. The outer sheathing of the system can include one or more laser cut patterns including, for example, one or more interrupted spiral laser cut patterns to control the flexibility and strength characteristics of the system.

[0572] Figure 91 illustrates the valve repair device 8200 coupled to the implant catheter assembly by a capture mechanism 3760. The actuation element 8102 extends through the implant catheter assembly, through the capture mechanism 3760, and is attached to the device 8200 by a coupler 8213. In Figure 91, the device 8200 is illustrated in the open condition to provide an unobstructed view of the coupler 8213. During release of the device 8200, however, the device 8200 will be in the fully closed position. In the illustrated example of Figure 91, the distal end of the actuation element 8102 is received within the coupler 8213 and include two longitudinally extending legs 8215 separated by a slot 8216. The longitudinally extending legs 8215 can be configured (e.g., shape-set) to be biased inward toward each other. The width adjustment element (not shown in Figure 91) extends coaxially within the actuation element 8102 and presses the longitudinally extending legs 8215 outward away from each other, which couples the actuationAttorney Docket No: TMTTEER-14077W001 element 8102 to the coupler 8213. Various different capture mechanisms are possible that function in similar or different ways, e.g., threaded portions, snap-fit connections, locks, clasps, suture, loops, etc.

[0573] In some implementations, after a release screw and the width adjustment element are pulled axially in the proximal direction, the width adjustment element is withdrawn relative to the actuation element 8102. Once the width adjustment element is withdrawn past the coupler 8213, the two longitudinally extending legs 8215 move inward to decouple the actuation element 8102 from the coupler 8213. The actuation element 8102 can be pulled until a proximal end of the actuation element clears the coupler or capture mechanism 3760 to release the coupler from the device.

[0574] Figure 92 illustrates an example clasp actuation line 3624. The clasp actuation line 3624 can be configured in a variety of ways, including, but not limited to, the materials used, the construction (e.g., braiding), the length, and the diameter. In the illustrated example of Figure 92, the clasp actuation line 3624 includes a proximal or terminal end 3754, a distal end 3756 opposite the proximal terminal end 3754, and a closed opening 3758, such as a loop or eyelet, formed at the distal end 3756. The distance between the proximal terminal end 3754 and the distal end 3756 define a length L of the clasp actuation line 3624. In some implementations, the length L is less than 100 inches or is less than 80 inches. In some implementations, the length is in the range of 65 inches to 75 inches, or 68 inches to 72 inches.

[0575] Figures 93-97 illustrate a simplified or schematic view (Figures 93-94) and a more detailed view (Figures 95-97) of the example implant catheter assembly 3610 coupled to the valve repair device 8200, in which each of the clasp actuation lines 3624 is coupled to a corresponding clasp control member 3628 positioned on the handle 3616. The valve repair device 8200 is coupled to the implant catheter assembly 3610 by the capture mechanism 3760 through which the actuation element 8102 (e.g., Figure 93) extends.

[0576] In some implementations, the proximal end of each clasp actuation line 3624 is attached to the line anchor 3748. Each clasp actuation line 3624 extends from the line anchor 3748, passes through the passage 3732 at the distal end of each line-engaging member 3730, and extends distally through the implant catheter assembly 3610 (e.g., into a catheter / sheath) to the device 8200. At the device, each clasp actuation line 3624 extends through an opening 8235 in a corresponding one of the clasps 8134 of the device 8200 and the closed loop 3758 attaches to theAttorney Docket No: TMTTEER-14077W001 capture mechanism 3760. The capture mechanism 3760 is configured to releasably attach the device 8200 to the implant catheter assembly 3610. The closed loops 3758 can attach to any suitable portion of the capture mechanism 3760 that allows the clasp actuation lines 3624 to be released when the capture mechanism 3760 releases the device 8200.

[0577] The capture mechanism 3760 can be configured in a variety of ways. In the example illustrated in Figures 93-97, the capture mechanism 3760 includes a plurality of flexible arms 8228 that are configured to pivot between a first or release configuration (Figures 94, 96-97) and a second or coupled configuration (Figures 93 and 95). The flexible arms 8228 are held in the coupled configuration by the actuation element 8102. When the actuation element 8102 is retracted from the capture mechanism 3760, the flexible arms 8228 pivot open to release the device 8200 from the implant catheter assembly 3610 (Figures 94 and 96-97). When the flexible arms 3672 pivot open, the closed loops 3758 at the distal ends 3756 of the clasp actuation lines 3624 are released from the capture mechanism 3760 allowing the clasp actuation lines 3624 to be withdrawn through the openings 8235 in the clasps 8134 and removed with the implant catheter assembly 3610.

[0578] Figures 98-100 illustrate the example capture mechanism 3760 through various stages of releasing the device 8200. The capture mechanism 3760 can be releasably coupled to a proximal collar’ 8251 of the device 8200. The capture mechanism 3760 includes the plurality of flexible arms 8228 and a plurality of stabilizer members 8230. The flexible arms 8228 and the stabilizer members 8230 can be configured in a variety of ways. In the illustrated example, the stabilizer members 8230 are formed as longitudinally projecting fingers or prongs having a distal terminal end. The flexible arms 8228 can comprise apertures 8232 and eyelets 8234. The flexible arms 8228 can be configured to pivot between a first or release configuration (Figures 99-100) and a second or coupled configuration (Figure 98). In the first configuration, the flexible arms 8228 extend radially outwardly relative to the stabilizer members 8230. In the second configuration, the flexible arms 8228 extend axially parallel to the stabilizer members 8230 and the eyelets 8234 radially overlap. The flexible arms 8228 can be configured (e.g., shape-set) to be biased to the first configuration.

[0579] The proximal collar 8251 of the device 8200 can include a central opening 8252 configured to slidably receive the actuation element 8102. The proximal collar 8251 can also include a plurality of bosses or projections 8254 and a plurality of guide openings 8255. TheAttorney Docket No: TMTTEER-14077W001 projections 8254 can extend radially outwardly and can be circumferentially offset (e.g., by about 90 degrees) relative to the guide openings 8255. The guide openings 8255 can be disposed radially outwardly from the central opening 8252. The projections 8254 and the guide openings 8255 of the proximal collar 8251 can be configured to releasably engage the capture mechanism 3760, as shown in Figure 98, to attach the device 8200 to the implant catheter assembly. In particular, as shown in Figure 98, when the capture mechanism 3760 is in the coupled configuration, the plurality of bosses or projections 8254 are received in the apertures 8232 of the flexible arms 8228, the plurality of stabilizer extensions or stabilizer members 8230 are received in the guide openings 8255, and the actuation element 8102 is received through the radially overlapping eyelets 8234. In addition, the clasp actuation lines 3624 are attached to the capture mechanism 3760 by receiving each of the stabilizer extensions / members 8230 through the closed loop 3758 of a corresponding clasp actuation line 3624 before the stabilizer extension / member 8230 is received in the guide openings 8255. Thus, the closed loop 3758 is captured between the proximal collar 8251 of the device 8200 and the capture mechanism 3760.

[0580] Referring to Figures 99-100, in some implementations, the device 8200 can be released from the implant catheter assembly by retracting the actuation shaft 8102 proximally relative to the capture mechanism 3760 such that the distal end portion of the actuation shaft 8102 withdraws from the eyelets 8234 of the capture mechanism 3760. This allows the flexible arms 8228 of the capture mechanism 3760 to move radially outwardly away from the projections 8254 of the proximal collar 8251. The stabilizer extensions or stabilizer members 8230 of the capture mechanism 3760 can then be withdrawn from the guide openings 8255 of the proximal collar 8251 by pulling the capture mechanism 3760 proximally, as shown by arrow Y in Figure 99. With the stabilizer members 8230 withdrawn from the guide openings 8255, the closed loops 3758 are no longer trapped on the stabilizer extensions / members 8230 by the proximal collar 8251. As a result of pulling the capture mechanism 3760 proximally, the stabilizer members 8230 withdraw from the closed loops 3758 freeing the clasp actuation lines 3624. The clasp actuation lines 3624 can then be retracted through the opening 8235 in the clasps 8134 thereby releasing the device 8200 from the implant catheter assembly 1611 as shown in Figure 100.

[0581] In some implementations, the clasp actuation lines 3624 can be released from the clasps 8134 of the device 8200 (or any of the devices described herein) one at a time (e.g., sequentially) or at the same time, while also not needing to “unfloss” or pull each clasp actuation line 3624 (or one-half of a doubled back clasp actuation line) through the implant catheter assembly 1611.Attorney Docket No: TMTTEER-14077W001This can be accomplished in a variety of different ways. Figures 101-111 and 114-143 illustrate some examples of configurations that can release the clasp actuation lines 3624 one at a time, while also not needing to “unfloss” or pull each clasp actuation line 3624 through the implant catheter assembly 1611.

[0582] Figures 101-103 schematically illustrate an example of a valve repair system 10100 that includes an implant catheter assembly 1611 coupled to a valve repair device 8200. The implant catheter assembly 1611 can include any of the components and / or features of any of the implant catheter assemblies shown and / or described herein. The valve repair device 8200 can include any of the components and / or features of any of the valve repair devices shown and / or described herein. In some implementations, the clasp actuation lines 3624 are attached to the gripping members or clasps 8134 by connections 10102 that are configured to release when a predetermined force is applied to the connections 10102 and / or when the clasp actuation lines are pulled a predetermined distance.

[0583] The connections 10102 can take a variety of forms. In some implementations, the connections 10102 can be configured to break when a predetermined force is applied to the connections 10102 and / or when the clasp actuation lines are pulled a predetermined distance. In some implementations, the connections 10102 can comprise two parts that are configured to decouple or separate when a predetermined force is applied to the connections 10102 and / or when the clasp actuation lines are pulled a predetermined distance.

[0584] The connections 10102 can be coupled to the gripping members or clasps 8134 in a variety of ways. In some implementations, the connections 10102 are connected directly to a movable portion, such as an arm, of a gripping member or clasp 8134. In some implementations, the clasp actuation lines 3624 are routed through loops or openings 8235 in the gripping members or clasps or formed by rings or sutures attached to the gripping members or clasps. In some implementations, the connections 10102 are connected to another portion of the valve repair device. For example, the connections 10102 can be connected to a closed end of the clasp, a paddle, such as the inner paddle, the spacer (when included), a central member or bushing, etc. In some implementations, the clasp actuation lines 3624 are routed through openings 8235 in the gripping members or clasps and the connections 10102 are connected to the implant catheter assembly 1611. For example, the connections 10102 can be connected to a coupler or capture mechanism 3760 or a catheter 10104 of the implant catheter assembly 1611.Attorney Docket No: TMTTEER-14077W001

[0585] In some implementations, the connections 10102 can be configured to release in a variety of different ways. In some implementations, the connections 10102 are configured to release when a predetermined force is applied to the clasp actuation lines 3624 that is higher than the force required to be applied to the clasp actuation lines 3624 to open the gripping members or clasps 8134. In some implementations, the connections 10102 are configured to release when a force is applied to the clasp actuation lines 3624 that is two times higher, five times higher, ten times higher, twenty times higher, or more than twenty times higher than the force required to be applied to the clasp actuation lines 3624 to open the gripping members or clasps 8134.

[0586] In some implementations, the connections 10102 are configured to release when a predetermined force is applied to the clasp actuation lines 3624 that is significantly higher than the force required to be applied to the clasp actuation lines 3624 to open the gripping members or clasps 8134. In some implementations, the connections 10102 are configured to release when a force is applied to the clasp actuation lines 3624 that is two times higher, five times higher, ten times higher, twenty times higher, or more than twenty times higher than the force required to be applied to the clasp actuation lines 3624 to open the gripping members or clasps 8134.

[0587] In some implementations, the connections 10102 can be configured to release when the clasp actuation lines 3624 are pulled a greater distance than is required to open the gripping members or clasps 8134. In some implementations, the connections 10102 are configured to release when the clasp actuation lines 3624 are pulled a distance that is 10% greater, 25% greater, 50% greater, 75% greater, 100% greater, or more than 100% greater than the distance that is required to open the gripping members or clasps 8134.

[0588] In some implementations, the implant catheter assembly 1611 can include an optional stop 10108 or stops that prevent or inhibit the clasp actuation lines 3624 from being pulled a greater distance than is required to open the gripping members or clasps 8134. The stop can allow the clasp actuation lines 3624 to open and close the gripping members or clasp, but prevents or inhibits the connections 10102 from being released. Once the valve repair device is attached to the native valve leaflets, the optional stop 10108 can be disengaged and / or removed to allow the clasp actuation lines 3624 to be pulled far enough to release the connections.

[0589] In the example illustrated by Figures 101-103, the implant catheter assembly 1611 includes a control handle 3616 and a catheter 10104. In some implementations, the controlAttorney Docket No: TMTTEER-14077W001 handle 3616 includes clasp control members 3628 that are connected to clasp actuation lines 3624. In some implementations, the handle 3616 includes optional stops 10108. The clasp control lines 3624 can be pulled by the clasp control members 3628 to open the gripping members or clasps.

[0590] In the example illustrated by Figures 101-103, each of the connections 10102 are connected to a closed end of the clasps 8134. In some implementations, the clasp control lines 3624 extend from the connections 10102, through openings 8235 in the clasps, through the catheter 10104, and connect to the clasp control members 3628.

[0591] In Figure 101, the clasp control members 3628 are in a distal position on the handle 3616 to close the clasps 8134. In Figure 102, one of the clasp control members 3628 is in a distal position on the handle 3616 to close one of the clasps 8134, while the other clasp control member 3628 is in a more proximal position on the handle 3616 to open the other clasp 8134. Figure 102 illustrates that the optional stops 10108 prevent or inhibit the clasp control members 3628 from moving far enough to release the connections 10102.

[0592] In Figure 103, an actuation clement 8102 has been moved to close paddles 9120, 9122 of the valve repair device 8200. One of the stops 10108 is released and one of the clasp control members 3628 is moved past the stop to release the connection 10102. Once the connections 10102 are released, the actuation element 8102 can also be released. In some implementations, the actuation element 8102 can be released before one or both of the connections 10102 are released. In some implementations, the device 8200 can be released from the implant catheter assembly by retracting the actuation shaft 8102 proximally. With the connections released, the clasp actuation lines 3624 can then be retracted through the openings 8235 of the clasps 8134 thereby releasing the device 8200 from the implant catheter assembly.

[0593] Figures 104-108 schematically illustrate an example of a valve repair system 10400 that includes an implant catheter assembly 1611 coupled to a valve repair device 8200. The implant catheter assembly 1611 can include any of the components and / or features of any of the implant catheter assemblies shown and / or described herein. The valve repair device 8200 can include any of the components and / or features of any of the valve repair devices shown and / or described herein. In some implementations, the clasp actuation lines 3624 are attached to the gripping members or clasps 8134 by connections 10402 that are configured to sequentially release orAttorney Docket No: TMTTEER-14077W001 release one at a time when the actuation element 8102 (e.g., wire, rod, tube, shaft, etc.) is disconnected and retracted from the device 8200.[05941 The connections 10402 can take a variety of forms. In some implementations, the connections 10402 are loops that are disposed around the actuation element 8102. In some implementations, the loops are configured to slide off the actuation element 8102 as the actuation element is retracted from the device 8200. In some implementations, the connections 10402 can have configurations other than loops. For example, the connections 10402 can comprise hooks, clamps, etc. that are configured to disconnect from the actuation element 8102 as the actuation element is retracted from the device 8200.

[0595] The connections 10402 can be coupled to the actuation element 8102 in a variety of ways. In some implementations, the clasp control lines 3624 and / or the connections 10402 extend through a component of the valve repair device 8200 and then the actuation element 8102 extends through the connections 10402. In some in some implementations, the clasp control lines 3624 and / or the connections 10402 extend through an optional coaptation element 9110 (e.g., a spacer, plug, membrane, gap filler, etc.), a cap 114, a coupler 3760, a bushing or receiver 8912, and / or an implant catheter and then the actuation element 8102 extends through the connections 10402. In some implementations, the clasp actuation lines 3624 are routed through loops or openings 8235 in the gripping members or clasps or formed by rings or sutures attached to the gripping members or clasps.

[0596] The connections 10402 can be configured to release in a variety of different ways. In some implementations, the connections 10402 are configured to release when the actuation element 8102 is retracted through the connection 10402 of the actuation line 3624.

[0597] In the example illustrated by Figures 104-108, the implant catheter assembly 1611 includes a control handle 3616 and a catheter 10104. In some implementations, the control handle 3616 includes clasp control members 3628 that are connected to clasp actuation lines 3624. The clasp control lines 3624 can be pulled by the clasp control members 3628 to open the gripping members or clasps.

[0598] In the example illustrated by Figures 104-108, each of the connections 10402 extend through openings or slots 10404 in the cap 114 and are disposed around the actuation element 8102. In some implementations, the clasp control lines 3624 extend from the connections 10402,Attorney Docket No: TMTTEER-14077W001 through the openings or slots 10404 in the cap 114, through openings 8235 in the clasps, through the catheter 10104, and connect to the clasp control members 3628.[05991 In Figure 104, the clasp control members 3628 are in a distal position on the handle 3616 to close the clasps 8134. In some implementations, the connections 10402 extend through the openings or slots 10404 in the cap 114. In Figure 105, one of the clasp control members 3628 is in a distal position on the handle 3616 to close one of the clasps 8134, while the other clasp control member 3628 is in a more proximal position on the handle 3616 to open the other clasp 8134.

[0600] In Figure 106, an actuation element 8102 has been moved by an optional actuation control 9626 (e.g., rotatable knob, push / pull knob, etc.) to close paddles 9120, 9122 of the valve repair device 8200. In some implementations, once the paddles 9120, 9122 are closed, the actuation element 8102 can be decoupled from the cap 114 (e.g., by unthreading or otherwise releasing).

[0601] In Figure 107, the actuation element 8102 is moved by the optional actuation control 9626 to release one of the connections 10402, while the other connection 10402 remains coupled to the actuation element 8102. In some implementations, the connections 10402 comprise loops of the clasp control members 3628 (e.g., lines or sutures). In some implementations, the actuation element 8102 is moved by the optional actuation control 9626 to allow one of the loops to slide off the actuation element 8102, while the other loop remains disposed around the actuation element 8102.

[0602] In Figure 108, the actuation element 8102 is moved by the optional actuation control 9626 to release the second of the connections 10402. In some implementations, the actuation element 8102 is moved by the optional actuation control 9626 to allow the second loop to slide off the actuation element 8102.

[0603] Once the connections 10402 are released, the actuation element 8102 can be fully released (i.e., pulled completely out of the device 8200). With the connections 10402 released, the clasp actuation lines 3624 can then be retracted through the openings 8235 of the clasps 8134 thereby releasing the device 8200 from the implant catheter assembly. The clasp actuation lines 3624 can be retracted through the openings 8235 of the clasps 8134 by pulling the implant catheter 10104 proximally.Attorney Docket No: TMTTEER-14077W001

[0604] Figures 109-111 schematically illustrate an example of a valve repair system 10900 that includes an implant catheter assembly 1611 coupled to a valve repair device 8200. The implant catheter assembly 1611 can include any of the components and / or features of any of the implant catheter assemblies shown and / or described herein. The valve repair device 8200 can include any of the components and / or features of any of the valve repair devices shown and / or described herein. In some implementations, the clasp actuation lines 3624 are threaded through openings 8235 or loops of the gripping members or clasps 8134 and arc secured to releasable connections 10902 or line locks that are configured to sequentially release the actuation lines 3624 or release the actuation lines one at a time.

[0605] The releasable connections 10902 or locks can take a variety of forms. In some implementations, the releasable connections 10902 comprise a shaft or tube 10904, a slidable member 10906, and an actuation element 10908. The shaft or tube 10904 can take a variety of forms. In some implementations, the shaft or tube 10904 includes a passage 10910 and a pocket 10912 or capture area.

[0606] The slidable member 10906 can take a variety of forms. In some implementations, the slidable member 10906 can be a plate, pin, rod, etc. that is configured to slide in the passage 1910 and into and out of the pocket 10912 or capture area.

[0607] The pocket 10912 or capture area can take a variety of forms. In some implementations, the pocket 10912 or capture area is sized and / or shaped such that the actuation line 3624 (e.g., suture) is secured (e.g., due to compression) when the slidable member 10906 is in the pocket 10912 or capture area.

[0608] The actuation element 10908 can take a variety of different forms. In some implementations, the actuation element 10908 is a line, such as a suture, a wire, a rod, a tube, etc. In some implementations, the actuation element 10908 is configured to move the slidable member 10906. In some implementations, the actuation element 10908 is configured to move the slidable member 10906 into and out of the pocket 10912 or capture area. In some implementations, the actuation element 10908 is configured to only pull the slidable member 10906 out of the pocket 10912 or capture area, and is not able to move the slidable member 10906 into the pocket 10912 or capture area.Attorney Docket No: TMTTEER-14077W001

[0609] In some implementations, the actuation lines 3624 are configured to slip or slide out of the pocket 10912 when the slidable member 10906 is retracted from the pocket 10912. In some implementations, the actuation lines 3624 can have knots, other stops, or loops that prevent or inhibit the lines 3624 from being pulled out of the pocket 10912 when the slidable member 10906 is disposed in the pocket.

[0610] The releasable connections 10902 can be configured to release in a variety of different ways. Referring to Figures 110 and 111, in some implementations the releasable connections 10902 are configured to release the actuation lines 3624 when the actuation element 10908 retracts the slidable member 10906 out of the pocket 10912 or capture area.

[0611] In the example illustrated by Figures 109- 111 , the implant catheter assembly 1611 includes a control handle 3616 and a catheter 10104. In some implementations, the control handle 3616 includes clasp control members 3628 that are connected to clasp actuation lines 3624 and clasp release members 10920 that are connected to the actuation elements 10908. The clasp control lines 3624 can be pulled by the clasp control members 3628 to open the gripping members or clasps. The actuation elements 10908 can be pulled by the clasp release members 10920 to pull the slidable members 10906 out of the pocket 10912 or capture area to release...

Claims

Attorney Docket No: TMTTEER-14077W001CLAIMSWhat is claimed is:

1. A system comprising: an implant catheter; a first movable clasp configured to secure a first native heart valve leaflet; a second movable clasp configured to secure a second native heart valve leaflet; a first clasp control member that extends through the implant catheter and through a first clasp opening or through a second clasp loop that is connected to the first clasp; a second clasp control member that extends through the implant catheter and through a second clasp opening or through a second clasp loop that is connected to the first clasp; a first releasable connection connected to the first clasp control member; a second releasable connection connected to the second clasp control member; and wherein the first releasable connection and the second releasable connection are configured to release the clasp control members one at a time without pulling the first clasp control member and the second clasp control member through the implant catheter.

2. The system of claim 1 wherein the first releasable connection comprises a loop attached to the first clasp control member and disposed around a retractable release element.

3. The system of claim 2 wherein the first clasp is coupled to a bushing and wherein the release element extends into the bushing.

4. The system of any one of claims 2-3 wherein the first clasp control member is released by pulling the release element out of the bushing.

5. A system comprising: a plurality of moveable clasps for securing a native leaflets of a heart valve; at least first and second clasp control members coupled to the moveable clasps; a locking system comprising: a channel;Attorney Docket No: TMTTEER-14077W001 a first half ring at least partially received in the channel; a second half ring at least partially received in the channel; wherein the first half ring is configured to engage and move the second half ring when the first half ring is moved between a locked position and an unlocked position; and wherein the second half ring is configured to engage and move the first half ring when the second half ring is moved between a locked position and an unlocked position.

6. The system of claim 5 further comprising: a plurality of projections disposed on the clasp control members; and a plurality of recesses disposed on the first half ring and the second half ring for at least partially receiving at least one projection.

7. A system comprising: a plurality of movable clasps for securing a native leaflets of a heart valve; at least first and second clasp control members coupled to the moveable clasps, each clasp control member comprising: a rod having a head portion and a rod portion, a chamber having a first section configured to allow movement of the head portion and having a second section configured to allow movement of the rod portion; and a biasing member disposed in the chamber between the head portion and the second section.

8. The system of claim 7 wherein the biasing member comprises a spring pre-load between the head portion and the second section of the chamber receiving the rod portion.

9. A catheter system for a medical device comprising: a central tube and at least a first side tube and a second side tube; the central tube having a central tube body comprising a first coiled material; the first side tube having a first side tube body comprising a second coiled material; and the second side tube having a second side tube body comprising a third coiled material.Attorney Docket No: TMTTEER-14077W00110. The catheter system of claim 9 wherein the first coiled material, the second coiled material and the third coiled material arc connected as single continuous coiled material.

11. A catheter system for a medical device comprising: an outer sheath defining an inner space; a central tube and at least a first side tube and a second side tube disposed in the inner space of the outer sheath; the central tube having a central tube body comprising a first coiled material; the first side tube having a first side tube body comprising a second coiled material; and the second side tube having a second side tube body comprising a third coiled material.

12. The catheter system of claim 11 wherein the first coiled material, second coiled material and third coiled material are connected as single continuous coiled material.

13. A clasp actuation line for actuating a clasp of a valve repair device, the clasp actuation line comprising: an elongated body extending between a first end and a second end; and a closed loop formed in each of the first end and the second end.

14. The clasp actuation line of claim 13, wherein the clasp of the valve repair device is actuated via a clasp control member and wherein the clasp control member is operatively coupled to the elongated body of the clasp actuation line between the closed loops formed in the first end and the second end of the clasp actuation line.

15. A method of forming a clasp actuation line for actuating a clasp of a valve repair device, the method comprising: braiding an elongated body; forming a closed loop in each of a first end and a second end of the elongated body; and stretching the elongated body.

16. The method of claim 15, wherein stretching the elongated body comprises routing the elongated body around Godet rollers.Attorney Docket No: TMTTEER-14077W00117. A method of forming a clasp actuation line for actuating a clasp of a valve repair device, the method comprising: braiding a continuous line, wherein the continuous line comprises a plurality of bifurcated sections separated by unitary sections; stretching the continuous line; and cutting the continuous line between adjacent bifurcated sections to form an elongated member.

18. The method of any of claim 17, further comprising heating the continuous line during the step of stretching the continuous line.

19. A method of forming a clasp actuation line for actuating a clasp of a valve repair device, the method comprising: weaving an elongated body; and forming a closed loop in each of a first end and a second end of the elongated body.

20. The method of claim 19, wherein the line is formed by weaving warp yarns and weft yams in a weaving direction, and wherein the warp yarns are aligned with the weaving direction.

21. A method of forming a clasp actuation line for actuating a clasp of a valve repair device, the method comprising: weaving a continuous line, wherein the continuous line comprises a plurality of bifurcated sections separated by unitary sections; and cutting the continuous line between adjacent bifurcated sections to form an elongated member.

22. The method of claim 21, wherein the continuous line is formed by weaving warp yams and weft yams in a weaving direction, and wherein the warp yams are aligned with the weaving direction.

23. A system comprising: a plurality of moveable clasps for securing native leaflets of a heart valve; a first clasp control member coupled to a first clasp of the moveable clasps; a second clasp control member coupled to a second clasp of the movable clasps; a locking system comprising:Attorney Docket No: TMTTEER-14077W001 a channel; a first half ring at least partially received in the channel; a second half ring at least partially received in the channel; and wherein the first half ring is configured to engage and move the second half ring when the first half ring is moved between a locked position and an unlocked position.

24. The system of claim 1, wherein the second half ring is configured to engage and move the first half ring when the second half ring is moved between a locked position and an unlocked position.

25. A system comprising: a plurality of movable clasps for securing a native leaflets of a heart valve; a first clasp control member coupled to a first clasp of the moveable clasps, the first clasp control member comprising: a rod having a head portion and a rod portion, a chamber having a first section configured to allow movement of the head portion and having a second section configured to allow movement of the rod portion; and a biasing member disposed in the chamber between the head portion and the second section.

26. The system of any of claim 25, wherein the biasing member is configured to compress between the head portion and the second section of the chamber.

27. A heart valve repair system comprising: a valve repair device for attaching to a native heart valve, the valve repair device comprising a plurality of paddles that can be moved between an open position and a closed position; wherein the plurality of paddles have a width that is adjusted between a first width and a second width; a control handle of a delivery system for delivering the valve repair device into a heart of a subject, the control handle comprising:Attorney Docket No: TMTTEER-14077W001 a retractor for moving a paddle width adjustment element to change the width of the plurality of paddles of the valve repair device; a paddle width control element for moving the retractor in a proximal direction and / or a distal direction; and a clutch that restricts movement of the retractor when an actuation force applied to the paddle width control element exceeds a predetermined limit.

28. The heart valve repair system of claim 27, wherein the paddle width control element comprises a knob for applying a torque to an internally threaded drive tube that engages an externally threaded drive head of the retractor to cause the retractor to move.

29. A heart valve repair system comprising: a valve repair device for attaching to a native heart valve, the valve repair device comprising a plurality of paddles that can be moved between an open position and a closed position and a spacer disposed between the plurality of paddles; wherein the spacer has a width that is adjusted between a first width and a second width; a control handle of a delivery system for delivering the valve repair device into a heart of a subject, the control handle comprising: a retractor configured to move a spacer width adjustment element to change the width of the spacer of the valve repair device; a spacer width control element configured to move the retractor in a proximal direction and / or a distal direction; and a clutch configured to prohibit movement of the retractor when an actuation force applied to the spacer width control element exceeds a predetermined limit.

30. The heart valve repair system of claim 29, wherein the clutch comprises a plurality of detents for engaging a plurality of corresponding grooves in an internally threaded drive tube, wherein the detents are biased into the grooves by biasing members.

31. A heart valve repair system comprising:Attorney Docket No: TMTTEER-14077W001 a valve repair device for attaching to a native heart valve, the valve repair device comprising a plurality of paddles that can be moved between an open position and a closed position; wherein the plurality of paddles have a width that is adjusted between a first width and a second width; a control handle of a delivery system for delivering the valve repair device into a heart of a subject, the control handle comprising: a retractor for moving a paddle width adjustment element to change the width of the plurality of paddles of the valve repair device; a paddle width control element that is actuated to move the retractor in a proximal direction and a distal direction; and a release knob of the retractor for rotating a paddle control element to release the paddle control element from the valve repair device.

32. The heart valve repair system of claim 31, further comprising a position indicator disposed on the release knob.

33. The heart valve repair system of claim 32, wherein a cover is rotatably attached to the retractor and wherein the cover comprises an indicator window to provide visibility as to the position of the position indicator.

34. A heart valve repair system comprising: a valve repair device for attaching to a native heart valve, the valve repair device comprising a pair of paddles that can be moved between an open position and a closed position and a spacer disposed between the pair of paddles; wherein the spacer has a width that is adjusted between a first width and a second width; a control handle of a delivery system for delivering the valve repair device into a heart of a subject, the control handle comprising: a retractor for moving a spacer width adjustment element to change the width of the spacer of the valve repair device;Attorney Docket No: TMTTEER-14077W001 a spacer width control element that is actuated to move the retractor in a proximal direction and a distal direction; and a release knob of the retractor for rotating the spacer width control element to release the spacer width control element from the valve repair device.

35. The heart valve repair system of claim 34, further comprising a position indicator disposed on the release knob.

36. The heart valve repair system of claim 35, further comprising a cover for covering the release knob, wherein the cover is attached to the retractor, wherein the cover is rotatably attached to the retractor, and wherein the cover comprises an indicator window to provide visibility as to the position of the position indicator.

37. A heart valve repair system comprising: a valve repair device for attaching to a native heart valve, the valve repair device comprising: a plurality of paddles that can be moved between an open position and a closed position; a pair of movable clasp arms that are movable relative to the plurality of paddles; a control handle of a delivery system for delivering the valve repair device into a heart of a patient, the control handle comprising: a fluid body housing enclosing an interior space; a clasp control element for moving a clasp actuation line to cause the movable clasp amis to open and close; a line-engaging member that is attached to and moved by the clasp control element through an orifice of the fluid body housing into the interior space; and an expansion portion of the fluid body housing.

38. The heart valve repair system of claim 37, wherein the expansion portion is formed from an elastic material.Attorney Docket No: TMTTEER-14077W00139. The heart valve repair system of any of claims 37-38, wherein the expansion portion is disposed in an opening of the fluid body housing.

40. The heart valve repair system of any one of claims 37-39, wherein the expansion portion comprises a silicone grommet.

41. The heart valve repair system of any of claims 37-40, wherein the expansion portion is integrally formed with the fluid body housing.

42. A heart valve repair system comprising: a control handle of a delivery system for delivering a valve repair device into a heart of a subject, the valve repair device comprising a plurality of paddles movable between an open position and a closed position for attaching to a native heart valve, the plurality of paddles having a width that is adjustable between a first width and a second width; the control handle comprising: a retractor for moving a paddle width adjustment element to change the width of the plurality of paddles of the valve repair device; a paddle width control element for moving the retractor in a proximal direction and / or a distal direction; and a clutch that restricts movement of the retractor when an actuation force applied to the paddle width control element exceeds a predetermined limit.

43. The heart valve repair system of claim 42, wherein the paddle width control element comprises a knob for applying a torque to an internally threaded drive tube that engages an externally threaded drive head of the retractor to cause the retractor to move.

44. A heart valve repair system comprising: a control handle of a delivery system for delivering a valve repair device into a heart of a subject, the valve repair device comprising a plurality of paddles that can be moved between an open position and a closed position for attaching to a native heart valve, and an adjustable width spacer disposed between the plurality of paddles;Attorney Docket No: TMTTEER-14077W001 the control handle comprising: a retractor configured to move a spacer width adjustment clement to change a width of the adjustable width spacer between a first width and a second width; a spacer width control element configured to move the retractor in a proximal direction and / or a distal direction; and a clutch configured to prohibit movement of the retractor when an actuation force applied to the spacer width control element exceeds a predetermined limit.

45. The heart valve repair system of claim 44, wherein the spacer width control element comprises a knob for applying a torque to an internally threaded drive tube that engages an externally threaded drive head of the retractor to cause the retractor to move.

46. A system comprising: an implant catheter; a first paddle; a first movable clasp coupled to the first paddle, wherein the first movable clasp is configured to secure a first native heart valve leaflet; a second paddle; a second movable clasp coupled to the second paddle, wherein the second movable clasp is configured to secure a second native heart valve leaflet; a single clasp control member that extends through the implant catheter, through a first clasp opening or through a second clasp loop that is connected to the first clasp, and through a second clasp opening or through a second clasp loop that is connected to the first clasp; a single releasable connection connected to the single clasp control member; a paddle actuation element configured to move the first and second paddles between an open position and a closed position; and wherein the single releasable connection comprises a single loop disposed around the paddle actuation element.

47. A system comprising: an implant catheter;Attorney Docket No: TMTTEER-14077W001 a first movable clasp configured to secure a first native heart valve leaflet; a second movable clasp configured to secure a second native heart valve leaflet; a first clasp control member that extends through the implant catheter; a second clasp control member that extends through the implant catheter; wherein the first clasp control member is configured to push the first movable clasp to an open position; and wherein the second clasp control member is configured to push the second movable clasp to an open position.

48. A system comprising: a catheter; a valve repair device or a replacement valve coupled to the catheter; a control handle coupled to the catheter, wherein the control handle is configured to move one or more movable components of the valve repair device or the replacement valve; a rotary travel limiter disposed in the control handle; and wherein the rotary travel limiter is configured to limit one or more of a flex of the catheter and movement of one or more of the one or more movable components of the valve repair device or the replacement valve.

49. The system of claim 48 wherein the rotary travel limiter comprises a rotatable input, one or more female receptacles, a slidable male member, and a slotted drive member.

Images