Heart valve repair device and delivery device therefor

Abstract

An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The implantable device or implant can expand and contract. For example, the implantable device or implant can be constricted during delivery and can expand when implanted onto the native heart valve.

Description

Technical Field

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 354,617, filed Jun. 22, 2022, which is hereby incorporated by reference in its entirety.

Background Art

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) play important functions in ensuring the forward flow of blood properly supplied through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus their effectiveness can be reduced. When such damage occurs to the valve, it can lead to severe cardiovascular disorders or death. A damaged valve can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can cause complications. Transvascular techniques can be used to introduce and implant artificial devices in a much less invasive manner than open-heart surgery. As one example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, advancing it up the inferior vena cava, and into the right atrium). Thereafter, the septum is punctured and the catheter is passed into the left atrium. Similar transvascular techniques can be used, starting in the same manner as the transseptal technique but not reaching the puncture of the septum. Instead, a delivery catheter is rotated towards the tricuspid valve within the right atrium and an artificial device is implanted inside the tricuspid valve.

[0003] A healthy heart has a generally conical shape that tapers towards the apex and base. The heart has a four-chamber structure, including a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly 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 anatomical structure from other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of native valve tissue surrounding the opening of the mitral valve, and a pair of cardiac valve leaflets or cusps that extend downward from the annulus into the left ventricle. The annulus of the mitral valve can form a "D" shape, an elliptical shape, or some other non-circular cross-sectional shape with a major axis and a minor axis. The anterior cusp may be larger than the posterior cusp, and when these are closed together, a generally "C" shaped boundary is formed between the contacting sides of the cusps.

[0004] When functioning properly, the anterior and posterior cusps function together as a one-way valve that allows blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as the "ventricular diastole" or "diastole"), the oxygen-rich blood 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 the "ventricular systole" or "systole"), the blood pressure in the left ventricle rises, causing the sides of the two cusps to be biased together so that the blood cannot flow back into the left atrium. Instead, the one-way mitral valve closes so that the blood is ejected from the left ventricle out through the aortic valve. To prevent the two cusps from prolapsing under pressure and folding back through the mitral annulus towards the left atrium, a plurality of fibrous cords called chordae tendineae tether the cusps to the papillary muscles within the left ventricle.

[0005] Valvular regurgitation involves the valve inappropriately allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the native mitral valve fails to close properly during systole of cardiac contraction and blood flows from the left ventricle into the left atrium. Mitral regurgitation is one of the most common conditions among valvular heart diseases. Mitral regurgitation can have many different causes, such as prolapse of the valve leaflets, dysfunction of the papillary muscles, dilation of the mitral valve annulus due to left ventricular dilation, or a combination of these. Mitral regurgitation at the central part of the valve leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one commissure (i.e., the position where the valve leaflets abut) of the valve leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the valve leaflets do not abut in the middle, so the valve does not close and there is regurgitation. Tricuspid regurgitation can be similar, except that it occurs on the right side of the heart.

Summary of the Invention

Means for Solving the Problems

[0006] The summary of the present invention is intended to provide some embodiments and is not intended to limit the scope of the present invention in any way. For example, any feature included in an embodiment of the summary of the present invention does not become a requirement according to the claims unless the claims explicitly list those features. Also, the features, components, steps, concepts, etc. described in the embodiments in the summary of the present invention and other parts of the present disclosure can be combined in various ways. The various features and steps described in the corresponding parts of the present disclosure may be included in the embodiments summarized herein.

[0007] An implantable device or implant (e.g., an implantable device, etc.) is configured to be positioned inside a native heart valve so that the native heart valve can form a more effective seal.

[0008] In some embodiments, an implantable device or implant includes an anchor portion that includes one or more anchors configured to attach to one or more leaflets of a native heart valve. Each anchor includes a plurality of paddles, each of which is movable between an open position and a closed position.

[0009] In some embodiments, an implantable device or implant includes a bonding element (e.g., a spacer, a gap filler, a contact surface, a wedge, a membrane, etc.), a cap, and an anchor portion. In some embodiments, the anchor portion includes one or more anchors coupled to the bonding element and the cap. In some embodiments, the cap is movable relative to the bonding element.

[0010] In some embodiments, each of the anchors includes a plurality of paddle members. The paddle members are configured to move between an open position and a closed position by moving the cap relative to the bonding element.

[0011] In some embodiments, an implantable device or implant includes an anchor that includes a paddle frame. In some embodiments, the paddle frame has an inner frame member and an outer frame member or portion having at least two outer arms. In some embodiments, each of the outer arms is connected to the inner frame member at a corresponding or respective distal connection point and extends proximally towards the proximal portion of the device.

[0012] In some embodiments, an implantable device or implant includes an anchor that includes a paddle frame. The paddle frame includes a rigid inner frame member and a flexible outer member or portion.

[0013] In some embodiments, an implantable device or implant includes an anchor that includes a paddle frame having an inner frame portion and at least two outer arms. In some embodiments, each of the outer arms is connected to the inner frame member at a corresponding or respective distal connection point and extends proximally towards the proximal portion of the device.

[0014] In some embodiments, one or more actuation lines can be connected to the paddle frame so that a user can provide tension to the actuation line to move the paddle frame from an extended position having an extended width to a constricted position having a constricted width, where the extended width is greater than the constricted width.

[0015] In some embodiments, one or more actuation lines extend from a proximal portion, through a joining element to a distal portion, along each of the outer arms from the distal portion to the proximal portion, and radially inwards from the proximal portion to connect to a fixed position on the device relative to the outer arm.

[0016] In some embodiments, an implantable device or implant (e.g., an implantable device, etc.) is configured to be positioned within a native heart valve by a delivery catheter.

[0017] In some embodiments, a method for repairing a patient's native valve includes delivering an implantable repair device to the native valve. In some embodiments, the implantable device or implant includes a joining element, a distal portion comprising a cap, and an anchor portion comprising one or more anchors coupled to the joining element and the cap.

[0018] In some embodiments, the anchor comprises a paddle frame having an inner paddle, an outer paddle, and at least two outer arms connected to an inner frame member at corresponding or respective distal connection points and extending proximally to the proximal portion of the device.

[0019] In some embodiments, the implantable repair device includes one or more actuation lines connected to the paddle frame.

[0020] In some embodiments, one or more actuation lines extend from the proximal portion, through the engagement element to the distal portion, along each of the outer arms from the distal portion to the proximal portion, and radially inwardly from the proximal portion to connect to a fixed position on the device relative to the outer arm.

[0021] In some embodiments, the method includes moving a cap relative to the engagement element to move an anchor from an open position to a closed position to capture a native valve leaflet between the engagement element and the inner and outer paddles, and applying tension to an actuation line to move a paddle frame from an expanded position having an expanded width to a constricted position having a constricted width.

[0022] The above-described methods and any methods using the systems, assemblies, devices, apparatuses, etc. described herein can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, cadaver heart, virtual person, simulator, etc.). In a simulation, body parts can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can optionally include a computerized and / or physical representation.

[0023] In some embodiments, an implantable device includes an anchor portion having one or more anchors configured to attach to one or more leaflets of a native heart valve. In some embodiments, each of the one or more anchors includes a plurality of paddles and a paddle frame.

[0024] In some embodiments, the paddle frame has an inner frame member and at least two outer arms. In some embodiments, each of the outer arms is connected to the inner frame member at respective distal connection points and extends proximally relative to the proximal portion of the implantable device.

[0025] In some embodiments, one or more actuation lines can be connected to the paddle frame so that a user can provide tension to the one or more actuation lines to move the paddle frame from an extended position having an extended width to a constricted position having a constricted width.

[0026] In some embodiments, one or more actuation lines extend from a proximal portion to a distal portion, from the distal portion to the proximal portion along each of the outer arms, and radially inwardly from the proximal portion to connect to a fixed position on an embedded device relative to the outer arm. One or more anchors are configured to move between an open position and a closed position.

[0027] In some embodiments, the embedded device can be used in a valve repair system that includes a delivery device having a lumen. The embedded device can be used in a method for repairing a patient's native valve.

[0028] In some embodiments, the fixed position can be on an inner frame member. The fixed position can be an opening on the inner frame member at the proximal portion of the embedded device. The opening can connect the inner frame member to a paddle among a plurality of paddles. The fixed position can be on a paddle clip.

[0029] In some embodiments, providing tension to one or more actuation lines pivots, articulates, or bends each of the outer arms inwardly about a distal connection point.

[0030] In some embodiments, each outer arm has a first portion that extends distally from a respective distal connection point, a second portion that extends proximally toward a proximal portion, and a winding portion that connects the first portion to the second portion.

[0031] In some embodiments, by providing tension to one or more actuation lines, each of the outer arms can move by hinges at the turn portion and at respective distal connection points.

[0032] In some embodiments, when the paddle frame moves from the extended position to the constricted position, a first distance between the first portion and the inner frame member and a second distance between the second portion and the first portion are reduced.

[0033] In some embodiments, in the constricted position, the second portion can overlap the inner frame member.

[0034] In some embodiments, each of the outer arms can have a proximal tip. In the constricted position, the proximal tip can be adjacent to the fixed position.

[0035] In some embodiments, each of the outer arms has a length, and the plurality of openings are spaced along the length for receiving one of the one or more actuation lines. One of the plurality of openings can be located at the proximal tip.

[0036] In some embodiments, a biasing member is associated with each of the outer arms. In some embodiments, the biasing member can be configured to bias the outer arms outwardly.

[0037] In some embodiments, the biasing member can be positioned around one or more actuation lines. In some embodiments, the biasing member can comprise a coil. In some embodiments, the biasing member can comprise a fabric material. In some embodiments, the biasing member can comprise a cell design. The biasing member can be integrally formed with the paddle frame.

[0038] In some embodiments, a strain relief feature is incorporated within the paddle frame. In some embodiments, the strain relief feature can comprise one or more cutouts within the paddle frame. In some embodiments, the paddle comprises a shape memory alloy.

[0039] In some embodiments, each of the plurality of paddles can include an inner paddle and an outer paddle. In some embodiments, each of the one or more anchors can include at least one clasp corresponding to the paddle.

[0040] The above systems, assemblies, devices, apparatuses, components, etc. can all be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safe use on patients, and the methods herein can include (or additional methods can include or consist of) the sterilization (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more systems, devices, apparatuses, components, etc. described herein.

[0041] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts are designated by like reference numerals.

[0042] To further clarify various aspects of the embodiments of the present disclosure, certain specific examples and embodiments will be described in more detail by reference to various aspects of the accompanying drawings. These drawings depict only examples of the embodiments of the present disclosure and are not to be considered as limiting the scope of the present disclosure. Further, although the drawings may be shown to scale for some embodiments, they are not necessarily shown to scale for all embodiments. The embodiments of the present disclosure, as well as other features and advantages, will be described and explained with additional specificity and detail through the use of the accompanying drawings.

Brief Description of the Drawings

[0043]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

Figure 25

Figure 26

Figure 27

Figure 28A

Figure 28B

Figure 29

Figure 30

Figure 31

Figure 32

Figure 33

Figure 34

Figure 35

Figure 36

Figure 37

Figure 38

Figure 39

Figure 40

Figure 41

Figure 42

Figure 43

Figure 44

Figure 45

Figure 46

Figure 47

Figure 48

Figure 49

Figure 50

Figure 51

Figure 52

Figure 53

Figure 54

Figure 55

Figure 56A

Figure 56B

Figure 56C

Figure 56D

Figure 56E

Figure 56F

Figure 56G

Figure 56H

Figure 57

Figure 58

Figure 59

Figure 60

Figure 61

Figure 62

Figure 63

Figure 64

Figure 65

Figure 66

Figure 67

Figure 68

Figure 69

Figure 70

Figure 71

Figure 72

Figure 73

Figure 74

Figure 75

Figure 76

Figure 77

Figure 78

Figure 79

Figure 80

Figure 81

Figure 82

Figure 83

Figure 84

Figure 85

Figure 86A

Figure 86B

Figure 87A

Figure 87B

Figure 88

Figure 89

Figure 90

Figure 91

Figure 92

Figure 93

Figure 94

Figure 95

Figure 96

Figure 97

Figure 98

Figure 99

Figure 100

Figure 101

Figure 102

Figure 103

Figure 104

Figure 105

Figure 106

Figure 107

Figure 108

Figure 109

Figure 110

Figure 111

Figure 112

Figure 113

Figure 114

Figure 115

Figure 116

Figure 117

Figure 118

Figure 119

Figure 120

Figure 121

Figure 122

Figure 123

Figure 124

Figure 125

Figure 126

Figure 127

Figure 128

Figure 129

Figure 130

Figure 131

Figure 132

Figure 133

Figure 134

Figure 135

Figure 136

Figure 137

Figure 138

Figure 139

Figure 140

Figure 141

Figure 142

Figure 143

Figure 144

Figure 145

Figure 146

Figure 147

Figure 148

Figure 149

Figure 150

Figure 151

Figure 152

Figure 153

Figure 154

Figure 155

Figure 156

Figure 157

Figure 158

Figure 159

Figure 160

Figure 161

Figure 162

Figure 163

Figure 164

Figure 165

Figure 166

Figure 167

Figure 168

Figure 169

Figure 170

Figure 171

Figure 172

Figure 173

Figure 174

Figure 175

Figure 176

Figure 177

Figure 178

Figure 179

Figure 180

Figure 181

Figure 182

Figure 183

Figure 184

Figure 185

Figure 186

Figure 187

Figure 188

Figure 189

Figure 190

Figure 191

Figure 192

Figure 193

Figure 194

Figure 195

Figure 196

Figure 197

Figure 198

Figure 199

Figure 200

Figure 201

Figure 202

Figure 203

Figure 204

Figure 205

Figure 206

Figure 207

Figure 208

Figure 209

Figure 210

Figure 211

Figure 212

Figure 213

Figure 214

Figure 215

Figure 216

Figure 217

Figure 218

Figure 219

Figure 220

Figure 221

Figure 222

Figure 223

Figure 224

Figure 225

Figure 226

Figure 227

Figure 228

Figure 229

Figure 230

Figure 231

Figure 232

Figure 233

Figure 234

Figure 235

Figure 236

Figure 237

Figure 238

Figure 239

Figure 240

Figure 241

Figure 242

Figure 243

Figure 244

Figure 245

Figure 246

Figure 247

Figure 248

Figure 249

Figure 250

Figure 251

Figure 252

Figure 253

Figure 254

Figure 255

Figure 256

Figure 257

Figure 258

Figure 259

Figure 260

Figure 261

Figure 262

Figure 263

Figure 264

Figure 265

Figure 266

Figure 267

Figure 268

Figure 269

Figure 270

Figure 271

Figure 272

Figure 273

Figure 274

Figure 275

Figure 276

Figure 277

Figure 278

Figure 279

Figure 280

Figure 281

Figure 282

Figure 283

Figure 284

Figure 285

Figure 286

Figure 287

Figure 288

Figure 289

Figure 290

Figure 291

Figure 292

Figure 293

Figure 294

Figure 295

Figure 296

Figure 297

Figure 298

Figure 299

Figure 300

Figure 301

Figure 302

Figure 303

Figure 304

Figure 305

Figure 306

Figure 307

Figure 308

Figure 309

Figure 310

Figure 311

Figure 312

Figure 313

Figure 314

Figure 315

Figure 316

Figure 317

Figure 318

Figure 319

Figure 320

Figure 321

Figure 322

Figure 323

Figure 324

Figure 325

Figure 326

Figure 327

Figure 328

Figure 329

Figure 330

Figure 331

Figure 332

Figure 333

Figure 334

Figure 335

Figure 336

Figure 337

Figure 338

Figure 339

Figure 340

Figure 341

Figure 342

Figure 343

Figure 344

Figure 345

Figure 346

Figure 347

Figure 348

Figure 349

Figure 350

Figure 351

Figure 352

Figure 353

Figure 354

Figure 355

Figure 356

Figure 357

Figure 358

Figure 359

Figure 360

Figure 361

Figure 362

Figure 363

Figure 364

Figure 365

Figure 366

Figure 367

Figure 368

Figure 369

Figure 370

Figure 371

Figure 372

Figure 373

Figure 374

Figure 375

Figure 376

Figure 377

Figure 378

Figure 379

Figure 380

Figure 381

Figure 382

Figure 383

Figure 384

Figure 385

Figure 386

Figure 387

Figure 388

Figure 389

Figure 390

Figure 391

Figure 392

Figure 393

Figure 394

Figure 395

Figure 396

Figure 397

Figure 398

Figure 399

Figure 400

Figure 401

Figure 402

Figure 403

Figure 404

Figure 405

Figure 406

Figure 407A

Figure 407B

Figure 407C

Figure 408A

Figure 408B

Figure 408C

Figure 408D

Figure 408E

Figure 408F

Figure 408G

Figure 409A

Figure 409B

Figure 409C

Figure 410A

Figure 410B

Figure 410C

Figure 410D

Figure 410E

Figure 410F

Figure 410G

Figure 410H

Figure 411A

Figure 411B

Figure 411C

Figure 411D

Figure 411E

Figure 412A

Figure 412B

Figure 412C

Figure 412D

Figure 412E

Figure 412F

Figure 412G

Figure 412H

Figure 412I

Figure 412J

Figure 412K

Figure 412L

Figure 413A

Figure 413B

Figure 414A

Figure 414B

Figure 415A

Figure 415B

Figure 415C

Figure 415D

Figure 416A

Figure 416B

Figure 416C

Figure 416D

Figure 417

Figure 418

Figure 419

Figure 420

Figure 421

Figure 422

Figure 423

Figure 424

Figure 425

Figure 426

Figure 427

Figure 428

Figure 429

Figure 430

Figure 431

Figure 432

Figure 433

Figure 434

Figure 435

Figure 436

Figure 437

Figure 438

Figure 439

Figure 440

Figure 441

Figure 442

Figure 443

Figure 444

Figure 445

Figure 446

Figure 447

Figure 448

Figure 449

Figure 450

Figure 451

Figure 452

Figure 453

Figure 454

Figure 455

Figure 456

DETAILED DESCRIPTION OF THE INVENTION

[0044] In the following description, reference is made to the accompanying drawings that illustrate some implementations of the present disclosure. Some implementations having different structures and operations do not depart from the scope of the present disclosure.

[0045] Some implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing defective heart valves. For example, implementations of implantable devices, valve repair devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, the individual components of the disclosed devices and systems can be combined unless they are mutually exclusive or physically impossible otherwise. Techniques, methods, operations, steps, etc. described or suggested in this specification or in reference materials incorporated herein can be implemented on living subjects (e.g., humans, other animals, etc.) or on simulations such as cadavers, cadaver hearts, simulators, virtual humans, etc. When implemented in a simulation, body parts, such as the heart, tissue, valves, etc., can be assumed to be simulated or, optionally, can be referred to as "simulated" (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can include computerized and / or physical representations of body parts, tissues, etc. The term "simulation" encompasses its use on cadavers, computer simulators, virtual humans (e.g., when simply demonstrated in air on a virtual heart), etc.

[0046] As described herein, when one or more components are described as being interconnected in a connection, joining, fixing, coupling, attachment, or other manner, such an interconnection can be direct as between the components or can be indirect, such as by using one or more intermediate components. Also, references herein to "member", "component", or "portion" are not limited to a single structural member, component, or element, but can include an assembly consisting of components, members, or elements. Also, the terms "substantially" and "about" as used herein are defined as being at least near to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0047] Figures 1 and 2 are cross-sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV, respectively, i.e., by the atrioventricular valves. In addition, 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 valve leaflets (e.g., leaflets 20, 22 shown in FIGS. 3-6 and leaflets 30, 32, 34 shown in FIG. 7) that extend inwardly across their respective valve openings to form a one-way fluid occluding surface by coming together or "engaging" in the flow. The native valve repair system of the present application is described and / or illustrated frequently with respect to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and the left ventricle LV are described in more detail. However, the devices described herein can also be used in the repair of other native valves, e.g., the devices can be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0048] The left atrium LA receives oxygen-rich blood from the lungs. During the diastolic phase, i.e., the diastolic period as seen in Figure 1, the blood that has already been collected in the left atrium LA (during the systolic phase) moves into the left ventricle LV through the mitral valve MV due to the expansion of the left ventricle LV. During the systolic phase, i.e., the systolic period as seen in Figure 2, the contraction of the left ventricle LV pumps the blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV into the left atrium LA, and the blood is collected into the left atrium from the pulmonary veins. In some implementations, the devices described by this application are used to repair the function of a defective mitral valve MV. That is, the device is configured to help close the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle LV into the left atrium LA. Many of the devices described in this application are designed to easily grip and fix the native leaflets around a junction element (e.g., spacer, gap filler, contact surface, wedge, membrane, etc.) that serves as a filler within the regurgitation orifice and is beneficial in preventing or suppressing systolic backflow or regurgitation, but this is not essential.

[0049] Referring now to FIGS. 1-7, the mitral valve MV includes two valve leaflets, a front leaflet 20 and a rear leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense fibrous annular tissue surrounding 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 within the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from inverting. The mitral valve MV opens and closes in response to pressure changes within the left atrium LA and the left ventricle LV. The papillary muscles PM do not open and close the mitral valve MV. Rather, the papillary muscles PM support or reinforce the leaflets 20, 22 against the high blood pressure required to circulate blood throughout the body. The papillary muscles PM and the chordae tendineae CT together are known as subvalvular tissue, which functions to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) view shown in FIG. 3, the anatomical structure of the leaflets 20, 22 is such that the inner surfaces of the leaflets join at the free end portions and the leaflets 20, 22 begin to move apart or spread away from each other. The leaflets 20, 22 spread apart in the atrial direction until each leaflet contacts the annulus of the mitral valve.

[0050] Various disease processes can impair one or more of the favorable functions of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastin 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 right ventricle RV due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) can distort the geometry of the native valves, which can cause dysfunction of the native valves. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that result in prolapse and regurgitation due to dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV).

[0051] Generally, native valves can malfunction in different ways, including (1) valvular stenosis and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not open fully, thereby causing an obstruction to blood flow. Typically, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which thickens the leaflets and impairs the valve's ability to open fully and allow forward blood flow. Valvular regurgitation occurs when the valve leaflets do not close fully, thereby allowing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0052] There are three main mechanisms by which native valves become regurgitant or insufficient, and these mechanisms include Carpentier's type I, II, and III insufficiencies. Carpentier's type I insufficiency involves dilation of the annulus, as a result of which the normally functioning leaflets move apart and are unable to form a tight seal (i.e., the leaflets do not appose properly). Included in type I mechanism insufficiencies are perforations of the leaflets, such as those present in endocarditis. Carpentier's type II insufficiency involves one or more of the native valve leaflets prolapsing above the coaptation plane. Carpentier's type III insufficiency involves restriction of the motion of one or more of the native valve leaflets, such that the leaflets are abnormally constrained below the plane of the annulus. The restriction of the leaflets can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0053] Referring to FIG. 5, when a healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 are joined, thereby preventing 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 are displaced into the left atrium LA during systole, and as a result, the edges of the leaflets 20, 22 do not contact each other. If such a joining cannot be achieved, a gap 26 is formed between the anterior leaflet 20 and the posterior leaflet 22, whereby blood may flow backward from the left ventricle LV into the left atrium LA during systole, as shown by the mitral regurgitation MR flow path shown in FIG. 3. Referring to FIG. 6, the gap 26 can have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some situations, the gap 26 can have a width W greater than 15 mm. As described above, there are several different ways in which valve leaflets (e.g., leaflets 20, 22 of the mitral valve MV) can malfunction and cause valve regurgitation.

[0054] In any of the situations described above, a valve repair device or implant that can engage the anterior leaflet 20 and the posterior leaflet 22, close the gap 26, and prevent or suppress the backflow of blood through the mitral valve MV is desirable. As can be seen from FIG. 4, an abstract depiction of an implantable device, valve repair device, or implant 10 is shown embedded between the leaflets 20, 22 so that backflow does not occur during systole (compare FIG. 3 with FIG. 4). In some implementations, the joining elements (e.g., spacers, gap fillers, contact surfaces, wedges, membranes, etc.) of the device 10 have a generally tapered or triangular shape that naturally conforms to the geometry of the native valve and the nature of the leaflets that expand (toward the annulus). In this application, terms such as spacer, coaption element, joining element, and gap filler are used interchangeably and refer to elements that fill a portion of the space between the native valve leaflets and / or are configured such that the native valve leaflets engage or "coapt" (e.g., such that the native valve leaflets coapt not only with each other but also with the coaption element, joining element, spacer, etc.).

[0055] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the burden on the heart H, and if left untreated, can lead to extremely serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. This is because the left side of the heart (i.e., the left atrium LA, left ventricle LV, mitral valve MV, and aortic valve AV) is primarily responsible for circulating blood throughout the body. Therefore, due to the substantially higher pressure on the left side of the heart, dysfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening.

[0056] In the case of dysfunction of a native heart valve, either repair or replacement can be performed. Repair typically involves preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Since the stenotic lesion sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or stenotic pulmonary valve can remove the valve and replace it with a surgically implanted valve, or the valve can be replaced with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to deformation of the valve leaflets and / or surrounding tissues, and as described above, by interfering with the proper closure of the mitral valve MV or tricuspid valve TV, it allows retrograde or backflow of blood from the ventricle into the atrium (for example, when the mitral valve MV is deformed, it can allow retrograde or backflow from the left ventricle LV to the left atrium LA as shown in FIG. 3). Retrograde or backflow of blood from the ventricle into the atrium results in valvular insufficiency. Deformation of the structure or shape of the mitral valve MV or tricuspid valve TV is often repairable. In addition, backflow can occur due to dysfunction of the chordae tendineae CT (for example, the chordae tendineae CT can stretch or rupture), which allows the anterior leaflet 20 and posterior leaflet 22 to invert such that blood flows retrograde into the left atrium LA. The problems caused by dysfunctional chordae tendineae CT can be improved by repairing the structure of the chordae tendineae CT or mitral valve MV (for example, by fixing the valve leaflets 20, 22 at the affected part of the mitral valve).

[0057] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it will be understood that the devices and concepts provided herein can be used to repair any natural valve and any component of a natural valve. Such a device can be used between the leaflets 20, 22 of the mitral valve MV to prevent or arrest the backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any device and concept herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit the backflow of blood from the right ventricle into the right atrium. Additionally, any device and concept provided herein can be used together for all three of the leaflets 30, 32, 34 to prevent or arrest the backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally positioned between the three leaflets 30, 32, 34.

[0058] An exemplary implantable device (e.g., an implantable device, etc.) or implant may optionally have a joining element (e.g., a spacer, a healing element, a gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, the implantable device or implant can have any combination or any partial combination of the features disclosed herein without having a joining element. When included, the joining element (e.g., a healing element, a spacer, etc.) is configured to be positioned inside the natural heart valve opening to assist in filling the space between the valve leaflets and to form a more effective seal, thereby reducing or preventing the backflow described above. The joining element may have a structure that is impermeable to blood (or resistant to blood flow therethrough) and may have a structure that blocks blood from returning from the left ventricle into the left atrium and also from the right ventricle into the right atrium by allowing the natural valve leaflets to occlude around the joining element during ventricular systole. The device or implant can be configured to seal against two or three natural valve leaflets, i.e., the device can be used with the natural mitral valve and the natural tricuspid valve. Since the joining element can fill the space between appropriately functioning native valve leaflets that do not close completely (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34), the joining element is sometimes also referred to herein as a spacer.

[0059] Optional joining elements (e.g., spacers, healing elements, etc.) can have various shapes. In some implementations, the joining element can have an elongate cylindrical shape with a circular cross-sectional shape. In some implementations, the joining element can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the joining element can have an atrial portion positioned within or adjacent to the atrium, a ventricular portion or a lower portion positioned within or adjacent to the ventricle, and a side surface extending between native valve leaflets. In some implementations configured for use with the tricuspid valve, the atrial portion or upper portion is positioned within or adjacent to the right atrium, the ventricular portion or lower portion is positioned within or adjacent to the right ventricle, and the side surface extends between native tricuspid valve leaflets.

[0060] In some embodiments, the anchor can be configured to secure the device to one or both of the native valve leaflets such that the engagement element is positioned between the two native valve leaflets. In some embodiments configured for use in a tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid valve leaflets such that the engagement element is positioned between the three native valve leaflets. In some embodiments, the anchor can be attached to the engagement element at a location adjacent to the ventricular portion of the engagement element. In some embodiments, the anchor can be attached to an actuating element such as a shaft or an actuating wire to which the engagement element is also attached. In some embodiments, the anchor and the engagement element can be positioned independently of each other by moving each of the anchor and the engagement element separately along the longitudinal axis of the actuating element (e.g., an actuating shaft, an actuating rod, an actuating tube, an actuating wire, etc.). In some embodiments, the anchor and the engagement element can be positioned simultaneously by moving the anchor and the engagement element together along the longitudinal axis of the actuating element (e.g., a shaft, an actuating wire, etc.). The anchor can be configured to be positioned behind the native valve leaflet when implanted such that the valve leaflet is gripped by the anchor.

[0061] The device or implant can be configured to be implanted via a delivery system or other delivery means. The delivery system can comprise one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, etc. The engagement element and the anchor can be compressible to a radially compressed state and can be self-expanding to a radially expanded state when the compression pressure is released. The device can be configured such that the anchor radially expands away from the engagement element which is initially still compressed, to create a gap between the engagement element and the anchor. Thereafter, the native valve leaflet can be positioned within the gap. The engagement element can be radially expanded to close the gap between the engagement element and the anchor and capture the valve leaflet between the engagement element and the anchor. In some implementations, the anchor and the engagement element are optionally configured to self-expand. The implantation methods for the various implementations can vary and are more fully described hereinafter for each implementation. Additional information regarding these delivery methods and other available delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, and PCT Patent Application Publication No. 2020 / 076898, each of which is hereby incorporated by reference in its entirety for all purposes. These methods can be performed with the necessary modifications on a simulation such as a living animal, or a cadaver, a cadaver heart, an anthropomorphic phantom, a simulator (e.g., where a body part, heart, tissue, etc. is simulated).

[0062] The disclosed device or implant can be configured such that the anchor is connected to the valve leaflet and utilizes the tension from the native chordae tendineae to resist the high systolic pressure that biases the device towards the left atrium. During diastole, the device can rely on the compressive and holding forces exerted on the valve leaflet gripped by the anchor.

[0063] Referring now to FIGS. 8-15, an exemplary implanted device or implant 100 (e.g., an artificial spacer device, a valve repair device, etc.) is shown at various stages of deployment. Device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publications Nos. 2018 / 195215, 2020 / 076898, and 2019 / 139904, which are hereby incorporated by reference in their entirety. Device 100 can include any other features of the implanted device or implant described in this application or the applications cited above, and device 100 can be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0064] Device or implant 100 is deployed from a delivery system or other delivery means 102. 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, a pathway, combinations thereof, and the like. Device or implant 100 includes a junction portion 104 and an anchor portion 106.

[0065] In some embodiments, the junction portion 104 of the device or implant 100 is adapted to be embedded between the valve leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes a junction element or junction means 110 (e.g., spacer, plug, filler, foam, sheet, membrane, healing element, etc.) slidably attached to an actuating element 112 (e.g., actuating wire, actuating shaft, actuating tube, etc.). The anchor portion 106 includes one or more anchors 108, which are operable between an open state and a closed state and can take a variety of forms, such as paddles, gripping elements, or the like. Actuation of the actuating means or actuating element 112 causes the anchor portion 106 of the device 100 to open and close, gripping the native valve leaflets during implantation. The actuating means or actuating element 112 (as well as other actuating means and actuating elements herein) can take a variety of different forms (e.g., wire, rod, shaft, tube, screw, suture, line, strip, combinations thereof, etc.), can be made of a variety of different materials, and can have a variety of configurations. As one example, the actuating element can be threaded so that rotation of the actuating element causes the anchor portion 106 to move relative to the junction portion 104. Alternatively, the actuating element can be non-threaded such that pushing or pulling on the actuating element 112 causes the anchor portion 106 to move relative to the junction portion 104.

[0066] The anchor portion 106 and / or the anchors of the device 100, in some embodiments, include an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the junction means or junction element 110 by portions 124, 126, 128. The portions 124, 126, 128 can be articulated and / or flexible to move between all of the positions described hereinafter. Interconnection of the outer paddle 120, inner paddle 122, junction element 110, and cap 114 by the portions 124, 126, 128 can constrain the device to the positions and movements illustrated herein.

[0067] In some implementations, the delivery system 102 includes an actuatable catheter, an implant catheter, and an actuating means or element 112 (e.g., an actuating wire, an actuating shaft, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating means or element 112 extends through the delivery catheter and further through a coupling means or element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). The extension and retraction of the actuating element 112 increase and decrease, respectively, the distance between the coupling element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion). In some implementations, a collar or other attachment element removably attaches the coupling element 110 directly or indirectly to the delivery system 102, whereby the actuating means or element 112 slides through the collar or other attachment element and, in some implementations, through the coupling means or element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106 and / or the anchor 108.

[0068] In some implementations, the anchor portion 106 and / or the anchor 108 can include an attachment portion or a gripping member. The exemplary gripping member can include a clasp 130 that includes a base or fixed arm 132, a movable arm 134, an optional return, a friction enhancing element, or other securing means 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the joint portion 138 disposed proximate to the joining means or joining element 110. In some implementations, the clasp (e.g., optionally, a clasp with a return, etc.) has a flat surface and does not fit within the recess of the inner paddle. Rather, the flat portion of the clasp is disposed against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 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 member made of a material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary with respect to the inner paddle 122 when the movable arm 134 opens to open the clasp 130 and expose the optional return, friction enhancing element, or securing means 136.

[0069] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, flex, or pivot on the joint portion 138. The actuation line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.

[0070] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be given a spring load, whereby the clasp 130 continues to provide a clamping force against the grasped native valve tip in the closed position. This clamping force remains constant regardless of the position of the inner paddle 122. Optional returns, friction enhancing elements, or other securing means 136 of the clasp 130 can grip, clamp, and / or puncture the native valve tip to further secure it.

[0071] During implantation, the paddles 120, 122 can open and close to grip a native valve tip (e.g., a native mitral valve tip, etc.) between, for example, the paddles 120, 122 and / or between the paddles 120, 122 and the joining means or joining element 110. The clasp 130 can be used to grip and / or further secure the native valve tip by engaging the optional return, friction enhancing element, or securing means 136 with the valve tip and sandwiching the valve tip between the movable and fixed arms 134, 132. Optional returns, friction enhancing members, or other securing means 136 of the clasp 130 (e.g., optional returns, protrusions, ridges, grooves, textured surfaces, adhesives, etc.) can increase friction with the valve tip or can partially or fully puncture the valve tip. The actuation line 116 can be actuated separately so that each clasp 130 can be opened and closed separately. By operating separately, it is permitted to grip one valve tip at a time or to reposition the clasp 130 onto a valve tip that was not fully grasped without changing the good grip on the other valve tip. The clasp 130 can open and close relative to the position of the inner paddle 122 (as long as the inner paddle is within the open position or at least a partially open position), thereby permitting the valve tip to be gripped at various positions required by the particular situation.

[0072] Referring now to FIG. 8, device 100 is shown in an extended or fully deployed state for deployment from an implant delivery catheter of delivery system 102. Device 100 is disposed at the end of the catheter of delivery system 102 within the fully deployed position because it occupies a minimum amount of space in the fully deployed position and because it is permissible to use a minimum catheter (or to use a maximum device 100 for a given catheter size) in the fully deployed position. In the extended state, cap 114 is spaced from engagement means or engagement element 110 such that paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of outer paddle 120 and inner paddle 122 is about 180 degrees. Clasp 130 is maintained in a closed state during deployment through delivery system 102 such that optional return, friction enhancement member or other securing means 136 (FIG. 9) do not capture or damage delivery system 102 or tissue within the patient's heart. Actuation line 116 extends and can be attached to movable arm 134.

[0073] Referring now to FIG. 9, device 100 is shown in an elongated, unentangled state as in FIG. 8, but with clasp 130 in a fully open position within a range of about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130. It has been found that the complete opening of paddles 120, 122 and clasp 130 improves ease of detachment from a patient's anatomical structures such as chordae tendineae CT during implantation of device 100.

[0074] Referring now to FIG. 10, device 100 is shown in a retracted or fully closed state. The compact size of device 100 in the retracted state allows for easier manipulation and placement within the heart. To move device 100 from the extended state to the retracted state, actuating means or element 112 is retracted, pulling cap 114 towards joining means or element 110. Connection portion 126 (e.g., joint, flexible connection, etc.) between outer paddle 120 and inner paddle 122 is constrained such that the compressive force acting from cap 114 onto outer paddle 120 causes the paddle or gripping member to retract towards joining means or element 110 and move radially outwards. During movement from the open position to the closed position, outer paddle 120 maintains an acute angle with respect to actuating means or element 112. Outer paddle 120 can optionally be biased towards the closed position. During the same movement, inner paddle 122 is oriented away from joining means or element 110 in the open state and falls along the side of joining means or element 110 in the closed state, thus moving through a relatively large angle. In some implementations, inner paddle 122 is thinner and / or narrower than outer paddle 120, and connection portions 126, 128 (e.g., joints, flexible connections, etc.) connecting to inner paddle 122 can be made thinner and / or more flexible. For example, this increased flexibility can allow for greater movement than connection portion 124 connecting outer paddle 120 to cap 114. In some implementations, outer paddle 120 is narrower than inner paddle 122. Connection portions 126, 128 connected to inner paddle 122 can be made more flexible to allow for greater movement, for example, than connection portion 124 connecting outer paddle 120 to cap 114. In some implementations, inner paddle 122 can be the same width as or substantially the same width as the outer paddle.

[0075] Referring now to FIGS. 11 - 13, device 100 is shown in a partially open, grippable state. To transition from the fully closed state to the partially open state, by extending an actuating means or actuating element (e.g., an actuating wire, an actuating shaft, etc.), cap 114 is pushed away from the joining means or joining element 110, thereby pulling outer paddle 120 and, in turn, pulling inner paddle 122 to partially expand anchor or anchor portion 106. Actuating line 116 is also retracted, thereby opening clasp 130 so that the valve tip can be gripped. In some implementations, the pair of inner and outer paddles 122, 120 are moved integrally rather than independently by a single actuating means or a single actuating element 112. Also, the position of clasp 130 depends on the position of paddles 122, 120. For example, referring to FIG. 10, when paddles 122, 120 are closed, the clasp is also closed. In some implementations, paddles 120, 122 can be controllable independently. For example, device 100 can have two actuating elements and two independent caps (or other attachment portions), whereby one independent actuating element (e.g., a wire, a shaft, etc.) and a cap (or other attachment portion) are used to control one paddle, and the other independent actuating element and a cap (or other attachment portion) are used to control the other paddle.

[0076] Referring now to FIG. 12, extending one of the actuating lines 116 allows one of the clasps 130 to be closed. Referring now to FIG. 13, the other actuating line 116 is extended to allow the other clasp 130 to be closed. Either or both of the actuating lines 116 can be actuated repeatedly to open and close the clasp 130 repeatedly.

[0077] Referring now to FIG. 14, device 100 is shown in a fully closed and deployed state. Delivery system or means 102 and actuation means or element 112 are retracted, and paddles 120, 122 and clasp 130 are left in the fully closed position. When deployed, device 100 can be maintained in the fully closed position by a mechanical latch or biased to remain closed by the use of a spring material such as steel, other metals, plastics, composite materials, or a shape memory alloy such as nitinol. For example, connection portions 124, 126, 128, joint portion 138, and / or inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal such as steel or a shape memory alloy such as nitinol, where it can be manufactured from wire, sheet, tube, or laser sintered powder, and further biased to hold outer paddle 120 in a closed state around joining means or element 110 and to clamp clasp 130 around the natural valve tip. Similarly, the fixed arm 132 and movable arm 134 of clasp 130 are biased to clamp the valve tip. In some implementations, attachment or connection portions 124, 126, 128, joint portion 138, and / or inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from any other suitable elastic material such as a metal or polymer material to maintain device 100 in a closed state after implantation.

[0078] Figure 15 illustrates an embodiment in which paddles 120, 122 are independently controllable. The device 101 illustrated in Figure 15 is similar to the device illustrated in Figure 11, except that the device 100 of Figure 15 includes actuation elements configured as two independent actuation elements 111, 113 coupled to two independent caps 115, 117. To move the first inner paddle 122 and the first outer paddle 120 from the fully closed state to the partially open state, the actuation means or actuation element 111 is extended to push the cap 115 away from the joining means or joining element 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122 to partially expand the first anchor 108. To move the second inner paddle 122 and the second outer paddle 120 from the fully closed state to the partially open state, the actuation means or actuation element 113 is extended to push the cap 115 away from the joining means or joining element 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122 to partially expand the second anchor 108. The independent paddle control illustrated in Figure 15 can be implemented in any device disclosed in the present application. For comparison, in the embodiment illustrated in Figure 11, a pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation means or actuation element 112.

[0079] Referring now to FIGS. 16 - 21, the manner in which the implantable device 100 of FIGS. 8 - 14 is delivered and implanted within the native mitral valve MV of the heart H is shown. Referring to FIG. 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the delivery catheter / sheath in the fully open state as illustrated in FIG. 16. Thereafter, the implant / device is moved to the fully closed state shown in FIG. 17 by retracting the actuation means or actuation element 112.

[0080] As seen in FIG. 18, the implant / device is moved to a position within the ventricle LV in the mitral valve MV and is partially opened to enable grasping of the valve leaflets 20, 22. For example, as illustrated in FIG. 18, a steerable catheter can be advanced and maneuvered, or bent to position the steerable catheter. The implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant, as illustrated in FIG. 18.

[0081] Here, referring to FIG. 19, the implant catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasp 130. The actuating line 116 is extended to close one of the clasps 130 and capture the valve leaflet 20. FIG. 20 shows that by then extending the other actuating line 116, the other clasp 130 is closed to capture the remaining valve leaflet 22. Finally, as seen in FIG. 21, the delivery system 102 (e.g., a steerable catheter, an implant catheter, etc.), the actuating means or element 112, and the actuating line 116 are then retracted, and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0082] Here, referring to FIGS. 22 - 27, an example of an implantable device or implant or implant 200 is shown. The implantable device 200 is one of many different configurations that the device 100 schematically shown in FIGS. 8 - 14 could take. The device 200 can include any other features for the implantable devices or implants discussed in this application, and the device 200 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The device / implant 200 can be an artificial spacer device, a valve repair device, or another type of implant attached to the valve leaflets of a native valve.

[0083] In some embodiments, the implantable device or implant 200 includes a junction portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some embodiments, the junction portion 204 of the device optionally includes a junction element 210 (e.g., a spacer, a healing element, a plug, a membrane, a sheet, etc.) for implantation between the leaflets of a native valve. In some embodiments, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in a variety of ways. In some embodiments, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some embodiments, the attachment portion 205 includes a first collar or proximal collar 211 (or other attachment member) for engaging a capture mechanism 213 (FIGS. 43-49) of a delivery system 202 (FIGS. 38-42 and FIG. 49). The delivery system 202 can be the same as or similar to the delivery system 102 described elsewhere and can include 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 thereof, etc.

[0084] In some embodiments, the junction element 210 and the paddles 220, 222 are formed from a mesh, a woven fabric, a braid, or a metallic cloth formed in some other suitable manner, or a flexible material cut by laser cutting or some other method. The material can be a cloth, a shape memory alloy wire such as nitinol to provide shape setting capabilities, or any other flexible material suitable for implantation into the human body.

[0085] The actuating element 212 (e.g., an actuating shaft, an actuating rod, an actuating tube, an actuating wire, an actuating line, etc.) extends from the delivery system 202 to engage the implantable device or implant 200 and enable its actuation. In some implementations, the actuating element 212 extends through the capture mechanism 213, the proximal collar 211, and the engagement element 210 and engages the cap 214 of the distal portion 207. The actuating element 212 can be configured to removably engage the cap 214 by a screw connection or the like, such that the actuating element 212 can be disengaged from and removed from the device 200 after implantation.

[0086] The engagement element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddle 222. In some implementations, the engagement element 210 has an overall elongate and round shape, although other shapes and configurations are possible. In some implementations, the engagement element 210 has an oval shape or cross-section when viewed from above (e.g., FIG. 51), a tapered shape or cross-section when viewed in front (e.g., FIG. 23), and a round shape or cross-section when viewed in side (e.g., FIG. 24). The combination of these three geometries can result in a three-dimensional shape of the engagement element 210 that exemplifies the advantages described herein. The round shape of the engagement element 210 can also be seen to substantially follow or approximate the shape of the paddle frame 224 when viewed from above.

[0087] The size and / or shape of the engagement element 210 can be selected to minimize (preferably to one) the number of implants required for a patient while maintaining a low transvalvular gradient. In some embodiments, the anterior-posterior distance at the top of the engagement element is about 5 mm, and the medial-lateral distance at the widest position of the engagement element is about 10 mm. In some embodiments, the overall geometry of the device 200 can be based on these two dimensions and the overall shape plan described above. As a starting point for the device, it will be readily apparent that the device can have different dimensions by using other anterior-posterior distances and medial-lateral distances. Additionally, by using other dimensions and the shape plan described above, the device will have different dimensions.

[0088] In some embodiments, the outer paddle 220 is pivotally attached to the cap 214 of the distal portion 207 by the connection portion 221 and to the inner paddle 222 by the connection portion 223. The inner paddle 222 is pivotally attached to the engagement element by the connection portion 225. Thus, the anchor 208 is configured to be similar to a leg in that the inner paddle 222 is like the upper portion of the leg, the outer paddle 220 is like the lower portion of the leg, and the connection portion 223 is like the knee portion of the leg.

[0089] In some embodiments, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is reinforced by a reinforcing member such as a plate, rod, or the fixing portion 232 of the clasp 230. The hardening of the inner paddle allows the device to be moved to various different positions illustrated and described herein. The inner paddle 222, the outer paddle 220, and the junctions can all be interconnected as described herein to constrain the device 200 to the movements and positions shown and described herein.

[0090] In some implementations, paddle frame 224 is attached to cap 214 of distal portion 207 and extends to connection portion 223 between inner paddle 222 and outer paddle 220. In some implementations, paddle frame 224 is formed from a more rigid and harder material compared to the material forming paddles 222, 220 such that paddle frame 224 provides support for paddles 222, 220.

[0091] As seen in FIG. 51, paddle frame 224 provides an additional clamping force between inner paddle 222 and joint element 210 and assists in wrapping the valve tip around the side surface of joint element 210 for better sealing between joint element 210 and the valve tip. That is, paddle frame 224 can be configured to have a rounded three-dimensional shape extending from cap 214 to connection portion 223 of anchor 208. The connections between paddle frame 224, outer paddle 220 and inner paddle 222, cap 214, and joint element 210 can constrain each of these components to the movements and positions described herein. In particular, connection portion 223 is constrained by its connection between outer paddle 220 and inner paddle 222 and by its connection to paddle frame 224. Similarly, paddle frame 224 is constrained by its attachment to connection portion 223 (and thus inner paddle 222 and outer paddle 220) and by its attachment to cap 214.

[0092] By configuring the paddle frame 224 in this way, the surface area is increased as compared to only the outer paddle 220. Thereby, for example, it is possible to more easily grip and fix the natural valve leaflet. The increased surface area can also disperse the clamping force of the paddles 220 and the paddle frame 224 against the natural valve leaflet onto a relatively large surface of the natural valve leaflet in order to further protect the natural valve leaflet tissue. Referring again to FIG. 51, the increased surface area of the paddle frame 224 can also allow the natural valve leaflet to be clamped against the implant device or implant 200 such that the natural valve leaflet joins integrally around the joining member or joining element 210. This can, for example, improve the sealing of the natural valve leaflets 20, 22 and thus prevent or further reduce mitral regurgitation.

[0093] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 230 includes a base or fixed arm 232, a movable arm 234, an optional return 236, and a joint portion 238. The fixed arm 232 is attached to the inner paddle 222 with the joint portion 238 disposed in proximity to the joining element 210. The joint portion 238 carries a spring force such that when the clasp 230 is in the closed state, the fixed arm 232 and the movable arm 234 are biased towards each other. In some implementations, the clasp 230 includes friction enhancing elements or fixing means such as optional returns, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0094] In some embodiments, the fixed arm 232 is attached to the inner paddle 222 through a hole or slot 231 by a suture (not shown). The fixed arm 232 can be attached to the inner paddle 222 using any suitable means, such as screws or other fastening members, crimp sleeves, mechanical latches or snaps, welding, adhesives, clamps, latches, or the like. The fixed arm 232 is substantially stationary with respect to the inner paddle 222 when the clasp 230 is opened by releasing the movable arm 234, exposing an optional return or other friction enhancing element 236. The clasp 230 is opened by applying tension to an actuating line 216 (e.g., as shown in FIGS. 43-48) attached to a hole 235 in the movable arm 234, thereby causing the movable arm 234 to articulate, pivot, and / or flex on a joint portion 238.

[0095] Referring now to FIG. 29, an enlarged view of one of the valve tips 20, 22 gripped by a clasp such as clasp 230 is shown. The valve tips 20, 22 are gripped between the movable arm 234 and the fixed arm of the clasp 230. The tissue of the valve tips 20, 22 is not punctured by the optional barb or friction enhancing element 236, although in some implementations the optional barb 236 can partially or fully puncture the valve tips 20, 22. The angle and height of the optional barb or friction enhancing element 236 relative to the movable arm 234 assist in securing the valve tips 20, 22 within the clasp 230. In particular, the force to pull the implant away from the natural valve tips 20, 22 will encourage the optional barb or friction enhancing element 236 to engage further with the tissue, thereby ensuring better retention. The retention of the valve tips 20, 22 within the clasp 230 is further improved by the position of the fixed arm 232 located near the optional barb / friction enhancing element 236 when the clasp 230 is closed. In this configuration, the tissue is shaped into an S-shaped distortion path by the fixed arm 232, the movable arm 234, and the optional barb / friction enhancing element 236. Therefore, the force to pull the valve tips 20, 22 away from the clasp 230 will encourage the tissue to engage further with the optional barb / friction enhancing element 236 before the valve tips 20, 22 can escape. For example, the tension of the valve tip during diastole can encourage the optional barb 236 to pull towards the ends of the valve tips 20, 22. Therefore, the S-shaped path can utilize the tension of the valve tip during diastole and engage the valve tips 20, 22 more tightly with the optional barb / friction strengthening member 236.

[0096] Referring to FIG. 25, the device or implant 200 can also include a cover 240. In some implementations, the cover 240 can be disposed on the engagement element 210, the outer paddles 220 and the inner paddles 222, and / or the paddle frame 224. The cover 240 can be configured to prevent or reduce blood flow through the device or implant 200 and / or can be configured to promote ingrowth into natural tissue. In some implementations, the cover 240 can be a cloth or fabric such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to the fabric, the cover 240 can include a coating (e.g., a polymer) applied to the implantable device or implant 200.

[0097] Upon implantation, by opening and closing the paddles 220, 222 of the anchor 208, the natural valve leaflets 20, 22 can be gripped between the paddles 220, 222 and the engagement element 210. The anchor 208 is moved between a closed position (FIGS. 22-25) and various open positions (FIGS. 26-37) by extending and retracting the actuating element 212. The extension and retraction of the actuating element 212 increase and decrease the spacing between the engagement element 210 and the cap 214, respectively. Since the proximal collar 211 (or other attachment element) and the engagement element 210 slide along the actuating element 212 during actuation, by changing the spacing between the engagement element 210 and the cap 214, the paddles 220, 220 move between different positions to grip the mitral valve leaflets 20, 22 during implantation.

[0098] When opening and closing the device 200, a pair of inner and outer paddles 222, 220 are moved together, rather than independently, by a single actuating element 212. Also, the position of the clasp 230 depends on the position of the paddles 222, 220. For example, the clasp 230 is arranged such that closing of the anchor 208 simultaneously closes the clasp 230. In some implementations, the device 200 can be configured to have paddles 220, 222 that are controllable independently in the same manner (e.g., the device 100 illustrated in FIG. 15).

[0099] In some implementations, the clasp 230 further secures the natural valve tips 20, 22 by engaging the valve tips 20, 22 against an optional return and / or other friction enhancing element 236 and, further, by sandwiching the valve tips 20, 22 between the movable arm 234 and the fixed arm 232. In some implementations, the clasp 230 is a clasp with a return that increases friction with the valve tips 20, 22 and / or can partially or fully puncture the valve tips 20, 22. The actuation lines 216 (FIGS. 43 - 48) can be actuated individually to open and close each clasp 230 individually. By operating separately, it is allowed to grip one valve tip 20, 22 at a time, or to reposition the clasp 230 onto a valve tip 20, 22 that was not fully gripped without changing the good grip on the other valve tips 20, 22. The clasp 230 can open and close fully when the inner paddle 222 is not occluded, thereby allowing the valve tips 20, 22 to be gripped in a variety of positions required by a particular situation.

[0100] Referring now to FIGS. 22 - 25, device 200 is shown in a closed position. When closed, inner paddle 222 is disposed between outer paddle 220 and engagement element 210. Clasp 230 is disposed between inner paddle 222 and engagement element 210. When natural valve leaflets 20, 22 are successfully captured, device 200 is moved to and held in its closed position such that valve leaflets 20, 22 are fixed within device 200 by clasp 230 and pressed against engagement element 210 by paddles 220, 222. Outer paddle 220 can have a wide, curved shape that conforms to the curved shape of engagement element 210 (e.g., as seen in FIG. 51) to more securely grip valve leaflets 20, 22 when device 200 is occluded. The curved shape and circular edge of outer paddle 220 also prevent or inhibit tearing of valve leaflet tissue.

[0101] Referring now to FIGS. 30 - 37, the above-described implantable device or implant 200 is shown in various positions and configurations ranging from partial opening to full opening. Paddles 220, 222 of device 200 transition between each of the positions shown in FIGS. 30 - 37 from the closed position shown in FIGS. 22 - 25 to upward extension of activation element 212 from a fully retracted position to a fully extended position.

[0102] Referring now to FIGS. 30 and 31, device 200 is shown in a partially open position. Device 200 is moved into the partially open position by extending operating element 212. The extension of operating element 212 causes the bottoms of outer paddles 220 and paddle frame 224 to be pulled down. Outer paddles 220 and paddle frame 224 pull down inner paddle 222, and inner paddle 222 is connected to outer paddles 220 and paddle frame 224. Since proximal collar 211 (or other attachment element) and engagement element 210 are held in place by capture mechanism 213, inner paddle 222 can be articulated, pivoted, and / or flexed in the direction of the opening. Inner paddle 222, outer paddle 220, and the paddle frame all flex to the positions shown in FIGS. 30 and 31. By opening paddles 222, 220, and frame 224, a gap is formed between engagement element 210 and inner paddle 222 that can receive and grip natural valve tips 20, 22. This movement also exposes clasp 230, which can move between a closed position (FIG. 30) and an open position (FIG. 31) and can form a second gap for gripping natural valve tips 20, 22. The range of the gap between fixed arm 232 and movable arm 234 of clasp 230 is limited to the range in which inner paddle 222 spreads apart from engagement element 210.

[0103] Referring now to FIGS. 32 and 33, device 200 is shown in a laterally extended position or a laterally open position. Device 200 is moved to the laterally extended position or the laterally open position by continuing the extension of the actuating element 212 described above, thereby increasing the distance between the engaging element 210 and the cap 214 of the distal portion 207. By continuing the extension of the actuating element 212, the outer paddles 220 and the paddle frames 224 are pulled down, thereby spreading the inner paddles 222 further away from the engaging element 210. In the laterally extended position or the laterally open position, the inner paddles 222 extend horizontally more than at other positions of the device 200 and form an angle of approximately 90 degrees with the engaging element 210. Similarly, the paddle frames 224 are in their most expanded position when the device 200 is in the laterally extended position or the laterally open position. The increased gap formed at the laterally extended position or the laterally open position between the engaging element 210 and the inner paddles 222 allows the clasp 230 to open further (FIG. 33) before engaging the engaging element 210, thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0104] Referring now to FIGS. 34 and 35, an exemplary device 200 is shown in a three-quarter extended position. The device 200 is moved to the three-quarter extended position by continuing the extension of the actuating element 212 described above, thereby increasing the distance between the engaging element 210 and the cap 214 of the distal portion 207. By continuing the extension of the actuating element 212, the outer paddle 220 and the paddle frame 224 are pulled down, thereby spreading the inner paddle 222 further away from the engaging element 210. At the three-quarter extended position, the inner paddle 222 is open at an angle of greater than 90 degrees to about 135 degrees with respect to the engaging element 210. The paddle frame 224 spreads less than in the lateral extended position or the lateral open position and begins to move inwardly toward the actuating element 212 as the actuating element 212 extends further. The outer paddle 220 also bends rearwardly toward the actuating element 212. Similar to the lateral extended position or the lateral open position, the increased gap formed at the lateral extended position or the lateral open position between the engaging element 210 and the inner paddle 222 allows the clasp 230 to still open further (FIG. 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0105] Referring now to FIGS. 36 and 37, exemplary device 200 is shown in a fully extended position. Device 200 is moved to the fully extended position by continuing the extension of operating element 212 described above, thereby increasing the distance between engagement element 210 and cap 214 of distal portion 207 to the maximum distance allowable by device 200. By continuing the extension of operating element 212, outer paddle 220 and paddle frame 224 are pulled down, thereby spreading inner paddle 222 further away from engagement element 210. Outer paddle 220 and paddle frame 224 move to a position where they approach the operating element. In the fully extended position, inner paddle 222 is opened to an angle of approximately 180 degrees with respect to engagement element 210. Inner paddle 222 and outer paddle 220 are straight and extended in the fully extended position, forming an angle of approximately 180 degrees between paddles 222, 220. The fully extended position of device 200 provides the maximum size of the gap between engagement element 210 and inner paddle 222 and, in some implementations, also allows clasp 230 to fully open to approximately 180 degrees between fixed arm 232 and movable arm 234 of clasp 230 (FIG. 37). The position of device 200 is the longest and narrowest configuration. Thus, the fully extended position of device 200 can be a desired position for bailing device 200 out of a tried implantation or can be a desired position for placement within, for example, the delivery catheter of the device.

[0106] Configuring the implant 200 such that the anchor 208 can extend to a linear or substantially linear configuration (e.g., about 120 degrees to 180 degrees with respect to the engagement element 210) can provide several advantages. For example, this configuration can reduce the radially crimped profile of the implant 200. Also, by providing a large opening between the engagement element 210 and the inner paddle 222 to grip the natural valve leaflets 20, 22, it can be easier to grip the natural valve leaflets 20, 22. Additionally, the relatively narrow and linear configuration can prevent or reduce the possibility that the implant 200 becomes entangled within the natural anatomical structure (e.g., the chordae CT shown in FIGS. 3 and 4) when positioning and / or retrieving the implant 200 within the delivery system 202.

[0107] Referring now to FIGS. 38 - 49, an exemplary implantable device 200 is shown being delivered and implanted into the natural mitral valve MV of the heart H. As described above, the device 200 shown in FIGS. 38 - 49 includes an engagement element 210, a clasp 230, an inner paddle 222 and / or an outer paddle 220, and an optional cover 240 (e.g., FIG. 25) thereover. The device 200 is deployed from a delivery system 202 (which can include, for example, a steerable catheter and / or an implant catheter extendable from a guide sheath) and is held by a capture mechanism 213 (see, e.g., FIGS. 43 and 48), and is further actuated by extending or retracting an actuation element 212. The fingers of the capture mechanism 213 removably attach the collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held in a closed state around the collar 211 by the actuation element 212, and removing the actuation element 212 allows the fingers of the capture mechanism 213 to open and release the collar 211, enabling the capture mechanism 213 to be detached from the device 200 after the device 200 has been properly implanted.

[0108] Referring now to FIG. 38, the delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA, and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons described above with respect to device 100 (e.g., the implant catheter holding the device / implant can expand to deploy the device / implant from the steerable catheter). Thereafter, by retracting the actuating element 212, the device 200 is moved through a partially closed state (FIG. 39) to the fully closed state shown in FIGS. 40 and 41. The delivery system or catheter then maneuvers the device / implant 200 toward the mitral valve MV as shown in FIG. 41. Referring now to FIG. 42, when the device 200 is aligned with the mitral valve MV, the actuating element 212 extends to open the paddles 220, 222 to a partially open position and the actuating line 216 (FIGS. 43-48) is retracted to open the clasp 230 in preparation for grasping the valve leaflets. Next, as shown in FIGS. 43 and 44, the partially opened device 200 is inserted through the native valve until the valve leaflets 20, 22 are properly positioned between the inner paddle 222 and the engagement element 210 and further inside the open clasp 230 (e.g., by advancing the implant catheter from the steerable catheter).

[0109] FIG. 45 shows the device 200 with both clasps 230 in the closed state, but an optional return 236 of one of the clasps 230 disengages one of the valve tips 22. As seen in FIGS. 45 - 47, the misaligned clasp 230 is reopened and closed again to properly grip the escaped valve tip 22. When both valve tips 20, 22 are properly gripped, the device 200 is moved into the fully closed position shown in FIG. 48 by retracting the actuating element 212. When the device 200 is fully closed and embedded within the native valve, the actuating element 212 can be disengaged from and withdrawn from the cap 214 to release the capture mechanism 213 from the proximal collar 211 (or other attachment element), whereby the capture mechanism 213 can be withdrawn into the delivery system 202 (e.g., into a catheter / sheath) as shown in FIG. 49. Once deployed, the device 200 can be maintained in the fully closed position by mechanical means such as a latch, or biased to remain in the closed state by the use of a spring material such as steel and / or a shape memory alloy such as nitinol. For example, the outer paddles 220, 222 can be formed from steel or nitinol shape memory alloy manufactured in wire, sheet, tube or laser sintered powder, and are biased to hold the outer paddle 220 in a closed state around the inner paddle 222, joining element 210, and / or to hold the clasps 230 in a clamped state around the native valve tips 20, 22.

[0110] Referring to FIGS. 50 - 54, after the device 200 is implanted within the native valve, the joining element 210 functions as a gap filler within a valvular regurgitation orifice such as gap 26 within the mitral valve MV illustrated in FIG. 6 or within a gap within another native valve. In some implementations, when the device 200 is deployed between two opposing valve leaflets 20, 22, the valve leaflets 20, 22 no longer join with each other in the region of the joining element 210, but instead join with the joining element 210. This reduces the distance that the valve leaflets 20, 22 need to approach in order to close the mitral valve MV during systole, thereby facilitating the repair of functional valve disease that can cause mitral valve regurgitation. The reduction in the valve leaflet approach distance can also provide several other advantages. For example, the stress on the native valve is reduced or minimized by the reduction in the required approach distance of the valve leaflets 20, 22. Reducing the approach distance of the valve leaflets 20, 22 may require a reduction in the approach force, which can result in less tension on the valve leaflets 20, 22 and allow for a smaller reduction in the diameter of the valve annulus. The smaller or no reduction in the valve annulus can result in less reduction in the valvular orifice area compared to devices without joining elements or spacers. In this way, the joining element 210 can reduce the transvalvular gradient.

[0111] To fully fill the gap 26 between the valve leaflets 20, 22, the device 200 and its components can have a wide variety of different shapes and sizes. For example, the outer paddles 220 and paddle frames 224 can be configured to conform to the shape or geometry of the joining element 210, as shown in FIGS. 50 - 54. As a result, the outer paddles 220 and paddle frames 224 can engage both the joining element 210 and the native valve leaflets 20, 22. In some implementations, when the leaflets 20, 22 are joined to the joining element 210, the leaflets 20, 22 completely surround or "envelop" the entire joining element 210, thereby preventing or suppressing small leaks at the lateral and inner surfaces 201, 203 of the joining element 210. The interaction between the leaflets 20, 22 and the device 200 is revealed in FIG. 51, which shows a schematic atrial view or a surgeon's view showing the paddle frame 224 (which may not actually be visible from a true atrial view such as in FIG. 52) that conforms to the shape of the joining element 210. The opposing leaflets 20, 22 (the ends of which also may not be visible from a true atrial view, e.g., from FIG. 52) are brought closer together by the paddle frame 224 to completely surround or "envelop" the joining element 210.

[0112] This such joining of the leaflets 20, 22 to the lateral and inner surfaces 201, 203 of the joining element 210 (shown from the atrial side in FIG. 52 and from the ventricular side in FIG. 53) may seem to contradict the above description that the presence of the joining element 210 minimizes the distance that the leaflets need to be approximated. However, if the joining element 210 is accurately positioned in the regurgitant gap 26 and the regurgitant gap 26 is smaller than the width (inner - outer) of the joining element 210, the distance that the leaflets 20, 22 need to be approximated is still minimized.

[0113] FIG. 50 illustrates the geometric shapes of the junction element 210 and the paddle frame 224 from the perspective of the LVOT. As can be seen from this figure, the junction element 210 has a tapered shape that is small in the region near the region where the inner surfaces of the valve leaflets 20, 22 need to be joined, and becomes larger as the junction element 210 extends toward the atrium. Therefore, the shape of the depicted native valve is corresponded by the shape of the tapered junction element. Still referring to FIG. 50, the geometry of the tapered junction element, in combination with the shape of the expanded paddle frame 224 (toward the valve annulus) as shown, can assist in achieving capture at the lower ends of the valve leaflets, reducing stress, and minimizing the transvalvular gradient.

[0114] Referring to FIG. 54, the shapes of the junction element 210 and the paddle frame 224 can be defined based on the internal connectivity map of the native valve and the device 200. Two factors of these shapes are the junction of the valve leaflets to the junction element 210 and the reduction of the stress on the valve leaflets caused by the junction. Referring to FIGS. 54 and 24, for both joining the valve leaflets 20, 22 to the junction element 210 and reducing the stress applied by the junction element 210 and / or the paddle frame 224 to the valve leaflets 20, 22, the junction element 210 can have a circular shape or a rounded shape, and the paddle frame 224 can have an overall radius that extends substantially throughout the paddle frame 224. The rounded shape of the junction element 210 and / or the illustrated fully rounded shape of the paddle frame 224 disperses the stress on the valve leaflets 20, 22 over a largely curved engagement region 209. For example, in FIG. 54, the force on the valve leaflets 20, 22 by the paddle frame spreads along the full rounded length of the paddle frame 224 because the valve leaflet 20 attempts to open during diastole.

[0115] Referring now to FIG. 55, an example of an implantable device or implant 300 is shown. Implantable device 300 is one of many different configurations that device 100, schematically illustrated in FIGS. 8-14, can take. Device 300 can include any other optional features for the implantable devices or implants described in this application, and device 300 can be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0116] Implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, device / implant 300 includes a junction portion 304, which can optionally include a junction element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the valve tips 20, 22 of the native valve. In some implementations, anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, such as outer paddle 320, inner paddle 322, paddle extension member or paddle frame 324. The anchors can also include, and / or be coupled to, a clasp 330. In some implementations, attachment portion 305 includes a first collar or proximal collar 311 (or other attachment member) for engaging a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 43-49) of a delivery system (e.g., a delivery system such as the systems shown in FIGS. 38-42 and FIG. 49).

[0117] Anchors 308 can be attached to other parts of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, by welding, suturing, adhesives, links, latches, integrally formed, combinations of some or all of these, etc.). In some implementations, anchors 308 are attached to junction member or junction element 310 by connection portion 325 and to cap 314 by connection portion 321.

[0118] The anchor 308 can include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connection portion 323. The connection portion 323 can be attached to a paddle frame 324 that is hingedly attached to the cap 314 or other attachment portion. In this way, the anchor 308 is configured to be similar to a leg in that the inner paddle 322 is like the upper portion of the leg, the outer paddle 320 is like the lower portion of the leg, and the connection portion 323 is like the knee portion of the leg.

[0119] In an embodiment with a joining member or joining element 310, the joining member or joining element 310 and the anchor 308 can be joined together in various ways. For example, as shown in the illustrated embodiment, the joining element 310 and the anchor 308 can be joined together by integrally forming the joining element 310 and the anchor 308 as a single integral component. This can be achieved, for example, by forming the joining element 310 and the anchor 308 from a continuous piece 301 of braided material or woven material such as braided or woven nitinol wire. In the illustrated embodiment, the joining element 310, the outer paddle portion 320, the inner paddle portion 322, and the connection portions 321, 323, 325 are formed from a continuous piece of fabric 301.

[0120] Similar to the anchor 208 of the above-described implantable device or implant 200, the anchor 308 can be configured to transition between various configurations by axially moving the distal end of the device (e.g., the cap 314, etc.) relative to the proximal end of the device (e.g., the proximal collar 311 or other attachment member, etc.), and thus, the anchor 308 moves relative to the midpoint of the device. This movement can be along the longitudinal axis extending between the distal end (e.g., the cap 314, etc.) and the proximal end (e.g., the collar 311 or other attachment member, etc.) of the device. For example, the anchor 308 can be positioned in a fully extended configuration or a linear configuration (similar to the configuration of the device 200 shown in FIG. 36) by separating the distal end (e.g., the cap 314, etc.) from the proximal end of the device.

[0121] In some implementations, in the linear configuration, the paddle portions 320, 322 are aligned or linear in the direction of the longitudinal axis of the device. In some implementations, the connection portion 323 of the anchor 308 is adjacent to the longitudinal axis of the joining element 310 (similar to the configuration of the device 200 shown in FIG. 36). From the linear configuration, the anchor 308 can move to a fully folded configuration (e.g., FIG. 55) by, for example, moving the proximal and distal ends towards each other and / or towards the midpoint or center of the device. Initially, as the distal end (e.g., the cap 314, etc.) moves towards the proximal end and / or towards the midpoint or center of the device, the anchor 308 bends at the connection portions 321, 323, 325, and the connection portion 323 moves radially outward relative to the longitudinal axis of the device 300 and axially towards the midpoint and / or towards the proximal end of the device (similar to the configuration of the device 200 shown in FIG. 34). When the cap 314 continues to move towards the midpoint and / or towards the proximal end of the device, the connection portion 323 moves radially inward relative to the longitudinal axis of the device 300 and axially towards the proximal end of the device (similar to the configuration of the device 200 shown in FIG. 30).

[0122] In some embodiments, the clasp comprises a movable arm coupled to the anchor. In some embodiments, the clasp 330 (as shown in detail in FIG. 28B) comprises a base or fixed arm 332, a movable arm 334, an optional return / friction enhancing member 336, and a joint portion 338. The fixed arm 332 is attached to the inner paddle 322 with the joint portion 338 disposed proximate the engagement element 310. The joint portion 338 is provided with a spring force such that when the clasp 330 is in the closed state, the fixed arm 332 and the movable arm 334 are biased towards each other.

[0123] The fixed arm 332 is attached to the inner paddle 322 through a hole or slot 331 using a suture (not shown). The fixed arm 332 can be attached to the inner paddle 322 by any suitable means such as a screw or other fastening member, a crimp sleeve, a mechanical latch or snap, welding, an adhesive, or the like. The fixed arm 332 remains substantially stationary with respect to the inner paddle 322 when opening the clasp 330 by opening the movable arm 334 to expose the optional return 336. The clasp 330 is opened by applying tension to an actuation line (e.g., actuation line 216 shown in FIGS. 43 - 48) attached to the hole 335 of the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or flex on the joint portion 338.

[0124] In summary, the implantable device or implant 300 is similar in configuration and operation to the implantable device or implant 200 described above, except that the bonding element 310, the outer paddle 320, the inner paddle 322, and the connection portions 321, 323, 325 are formed from a single strip 301 of material. In some implementations, the piece of material 301 is woven or inserted through openings in the proximal collar 311, within the cap 314, and within the paddle frame 324 configured to receive the continuous piece of material 301, thereby attaching to the proximal collar 311, the cap 314, and the paddle frame 324. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, a portion of the device 300 has a single layer of the piece of material 301, and other portions are formed from multiple overlapping layers or stacked layers of the piece of material 301.

[0125] For example, FIG. 55 shows the bonding element 310 and the inner paddle 322 formed from multiple overlapping layers of the piece of material 301. The single continuous piece of material 301 can start and end at various locations of the device 300. The ends of the piece of material 301 can be located at the same or different locations of the device 300. For example, in the embodiment illustrated in FIG. 55, the piece of material 301 starts and ends at the location of the inner paddle 322.

[0126] Similar to the implantable device or implant 200 described above, the size of the bonding element 310 can be selected to minimize the number of implants (preferably one) required for a patient while maintaining a low transvalvular gradient. In particular, by forming many components of the device 300 from the piece of material 301, the device 300 can be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the bonding element 310 is less than 2 mm, and the inner-outer distance of the device 300 (i.e., the width of the paddle frame 324 wider than the bonding element 310) is approximately 5 mm at its widest.

[0127] The concepts disclosed in this application can be used in conjunction with a wide variety of different valve repair devices. FIGS. 56A-56H illustrate another example of one of a number of valve repair systems 40056 for repairing a patient's native valve to which the concepts of this application can be applied. The valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0128] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856 such as arms with optional returns. In one embodiment, the paddles 40656 can be integrally formed with the base assembly. For example, the paddles 40656 can be formed as an extension of a link of the base assembly. In the illustrated embodiment, the base assembly 40456 of the valve repair device 40256 has a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft. The coupler 40556 is mechanically connected to the paddles 40656 such that when the coupler 40556 moves along the shaft 40356, the paddles move between an open position and a closed position. Thus, the coupler 40556 is a means for mechanically coupling the paddles 40656 to the shaft 40356 and functions as a means for moving the paddles 40656 between their open and closed positions when moving along the shaft 40356.

[0129] In some implementations, the grasping member 40856 is pivotally connected to the base assembly 40456 (e.g., the grasping member 40856 can be pivotally connected to a shaft 40356 or any other suitable member of the base assembly), such that the grasping member can be moved to adjust the width of the opening 41456 between the paddle 40656 and the grasping member 40856. The grasping member 40856 can include an optional return portion 40956 for attaching the grasping member to the valve tissue when the valve repair device 40256 is attached to the valve tissue. The grasping member 40856 forms means for grasping the valve tissue (particularly the tissue of the valve leaflet) by means of an attachment means or attachment portion such as the optional return portion 40956. When the paddle 40656 is in the closed position, the paddle engages the grasping member 40856, such that when the valve tissue is attached to the return portion 40956 of the grasping member, the paddle acts as a retaining means or fixing means to hold the valve tissue in the grasping member and to fix the valve repair device 40256 to the valve tissue. In some implementations, the grasping member 40856 is configured to engage the paddle 40656, such that the return portion 40956 engages the valve tissue member and the paddle 40656 to fix the valve repair device 40256 to the valve tissue member. For example, in certain situations, it may be advantageous to maintain the paddle 40656 in the open position and move the grasping member 40856 outwardly towards the paddle 40656 to engage the valve tissue with the paddle 40656.

[0130] In the embodiments illustrated in FIGS. 56A-56H, a pair of paddles 40656 and a pair of grasping members 40856 are illustrated, but it will be understood that the valve repair device 40256 can include any suitable number of paddles and grasping members.

[0131] In some implementations, the valve repair system 40056 includes a placement shaft 41356 removably attached to the shaft 40356 of the base assembly 40456 in the valve repair device 40256. The placement shaft 41356 is removed from the shaft 40356 after the valve repair device 40256 is fixed to the valve tissue, removing the valve repair device 40256 from the rest of the valve repair system 40056. As a result, the valve repair device 40256 can remain attached to the valve tissue, and the delivery device 40156 can be removed from the patient's body.

[0132] The valve repair system 40056 can also include a paddle control mechanism 41056, a gripper control mechanism 41156, and a lock control mechanism 41256. The paddle control mechanism 41056 is mechanically attached to the coupler 40556 to move the coupler along the shaft, causing the paddle 40656 to move between an open position and a closed position. The paddle control mechanism 41056 can take any suitable form, such as a shaft or rod, for example. For example, the paddle control mechanism can include a hollow shaft and a catheter tube or sleeve that fits over the placement shaft 41356 and the shaft 40356 and is connected to the coupler 40556.

[0133] The gripper control mechanism 41156 is configured to move the gripping member 40856 so that the width of the opening 41456 between the gripping member and the paddle 40656 can be changed. The gripper control mechanism 41156 can take any suitable form, such as a line, suture, or wire, rod, catheter, etc.

[0134] The locking control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 functions as a locking means for locking the coupler 40556 in a stationary position relative to the shaft 40356 and can take a variety of different forms, and the type of the locking control mechanism 41256 can be indicated by the type of the lock used. In one embodiment, the lock 40756 takes the form of a lock that is often used in a caulking gun. That is, the lock 40756 includes a pivotable plate having a hole, and the shaft 40356 of the valve repair device 40256 is disposed inside the hole of the pivotable plate. In this embodiment, when the pivotable plate is in the inclined position, the pivotable plate engages with the shaft 40356 to maintain its position on the shaft 40356, but when the pivotable plate is in a substantially non-inclined position, the pivotable plate can move along the shaft (thereby allowing the coupler 40556 to move along the shaft 40356). In other words, the coupler 40556 is prevented or restricted from moving in the direction Y (as shown in FIG. 56E) along the shaft 40356 when the pivotable plate of the lock 40756 is in the inclined position (or the locked position), and the coupler can move in the direction Y along the shaft 40356 when the pivotable plate is in a substantially non-inclined position (or the unlocked position). In an embodiment where the lock 40756 includes a pivotable plate, the locking control mechanism 41256 is configured to engage with the pivotable plate to move the plate between the inclined position and the substantially non-inclined position. The locking control mechanism 41256 can be, for example, a rod, a suture, a wire, or any other member that can move the pivotable plate of the lock 40756 between the inclined position and the substantially non-inclined position. In some implementations, the pivotable plate of the lock 40756 is biased to the inclined position (or the locked position), and by using the locking control mechanism 41256, the plate can be moved from the inclined position to the substantially non-inclined position (or the unlocked position).In some implementations, the pivotable plate of the lock 40756 is biased to a substantially non-inclined position (or unlocked position), and by using the lock control mechanism 41256, the plate can be moved from the substantially non-inclined position to an inclined position (or locked position).

[0135] Figures 56E - 56F illustrate a valve repair device 40256 that is moved from an open position (shown in Figure 56E) to a closed position (shown in Figure 56F). The base assembly 40456 includes a first link 102156 extending from point A to point B, a second link 102256 extending from point A to point C, a third link 102356 extending from point B to point D, a fourth link 102456 extending from point C to point E, and a fifth link 102556 extending from point D to point E. The coupler 40556 is movably attached to the shaft 40356, and the shaft 40356 is fixed to the fifth link 102556. The first link 102156 and the second link 102256 are pivotably attached to the coupler 40556 at point A, such that movement of the coupler 40556 along the shaft 40356 moves the position of point A, and as a result, moves the first link 102156 and the second link 102256. The first link 102156 and the third link 102356 are pivotably attached to each other at point B, and the second link 102256 and the fourth link 102456 are pivotably attached to each other at point C. One paddle 40656a is attached to the first link 102156 such that movement of the first link 102156 moves the paddle 40656a, and the other paddle 40656b is attached to the second link 102256 such that movement of the second link 102256 moves the paddle 40656b. In some implementations, the paddles 40656a, 40656b can be connected to the links 102356, 102456 or can be extensions of the links 102356, 102456.

[0136] To move the valve repair device from the open position (shown in FIG. 56E) to the closed position (shown in FIG. 56F), the coupler 40556 is moved along the shaft 40356 in the direction Y, thereby moving the pivot point A with respect to the first link 102156 and the second link 102256 to a new position. By moving the coupler 40556 (and the pivot point A) in the direction Y, the portion located near point A of the first link 102156 is moved in the direction H, and the portion located near point B of the first link 102156 is moved in the direction J. The paddle 40656a is attached to the first link 102156 such that moving the coupler 40556 in the direction Y causes the paddle 40656a to move in the direction Z. Additionally, the third link 102356 is pivotally attached to the first link 102156 at point B, whereby moving the coupler 40556 in the direction Y causes the third link 102356 to move in the direction K. Similarly, by moving the coupler 40556 (and the pivot point A) in the direction Y, the portion located near point A of the second link 102256 is moved in the direction L, and the portion located near point C of the second link 102256 is moved in the direction M. The paddle 40656b is attached to the second link 102256 such that moving the coupler 40556 in the direction Y causes the paddle 40656b to move in the direction V. Additionally, the fourth link 102456 is pivotally attached to the second link 102256 at point C, whereby moving the coupler 40556 in the direction Y causes the fourth link 102456 to move in the direction N. FIG. 56F illustrates the final position of the valve repair device 40256 after the coupler 40556 has been moved as shown in FIG. 56E.

[0137] Referring to FIG. 56B, the valve repair device 40256 is shown in the open position (similar to the position shown in FIG. 56E), and the gripping member control mechanism 41156 is shown in a state where, by moving the gripping member 40856, a wider gap is provided at the opening 41456 between the gripping member and the paddle 40656. In the illustrated embodiment, the gripping member control mechanism 41156 includes a line such as a suture, a wire, etc., which is mounted through an opening in the end of the gripping member 40856. Both ends of the line extend through the delivery opening 51656 of the delivery device 40156. When the line is pulled in the direction Y through the delivery opening 51656, the gripping member 40856 is moved inward in the direction X, so that the opening 41456 between the gripping member and the paddle 40656 becomes wider.

[0138] Referring to FIG. 56C, the valve repair device 40256 is shown with the valve tissues 20, 22 disposed within the opening 41456 between the gripping member 40856 and the paddle 40656. Referring to FIG. 56D, after the valve tissues 20, 22 are disposed between the gripping member 40856 and the paddle 40656, the width of the opening 41456 between the gripping member and the paddle is made narrower by using the gripping member control mechanism 41156. That is, in the illustrated embodiment, when the line of the gripping member control mechanism 41156 is released or pushed out in the direction H from the opening 51656 of the delivery member, the gripping member 40856 can be moved in the direction D, whereby the width of the opening 41456 can be made narrower. Although the gripping member control mechanism 41156 is shown as widening the width of the opening 41456 between the gripping member and the paddle 40656 by moving the gripping member (FIG. 56C), it will be understood that there may be cases where it is not necessary to move the gripping member when positioning the valve tissue within the opening 41456. However, in certain situations, the opening 41456 between the paddle 40656 and the gripping member 40856 can become wider to receive the valve tissue.

[0139] Referring to FIG. 56G, the valve repair device 40256 is in a closed position and is fixed to the valve tissues 20, 22. The valve repair device 40256 is fixed to the valve tissue 20 by paddles 40656a, 40656b and gripping members 40856a, 40856b. In particular, the valve tissues 20, 22 are attached to the valve repair device 40256 by optional return portions 40956 of the gripping members 40856a, 40856b, and the paddles 40656a, 40656b engage the gripping members 40856 to fix the valve repair device 40256 to the valve tissues 20, 22.

[0140] To move the valve repair device 40256 from the open position to the closed position, the lock 40756 is moved to the unlocked state by a lock control mechanism 41256 (as shown in FIG. 56G). After the lock 40756 is in the unlocked state, the coupler 40556 can be moved along the shaft 40356 by a paddle control mechanism 41056. In the illustrated embodiment, the paddle control mechanism 41056 moves the coupler 40556 along the shaft in the direction Y, moving one paddle 40656a in the direction X and the other paddle 40656b in the direction Z. By moving the paddle 40656a in the direction X and the paddle 40656b in the direction Z, the paddles are engaged with the gripping members 40856a, 40856b and the valve repair device 40256 is fixed to the valve tissues 20, 22.

[0141] Referring to FIG. 56H, after fixing the valve repair device 40256 to the valve tissues 20, 22 by moving the paddle 40656 to the closed position (as shown in FIG. 56G), the lock 40756 is moved to the locked state by the lock control mechanism 41256 (FIG. 56G) to maintain the valve repair device 40256 in the closed position. After the valve repair device 40256 is maintained in the locked state by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by disconnecting the shaft 40356 from the placement shaft 41356 (FIG. 56G). In addition, the valve repair device 40256 is disconnected from the paddle control mechanism 41056, the gripping member control mechanism 41156, and the lock control mechanism 41256 (FIG. 56G). By removing the valve repair device 40256 from the delivery device 40156, it is possible to keep the valve repair device fixed to the valve tissues 20, 22 when removing the delivery device 40156 from the patient.

[0142] When implanting an implantable device or implant into a native heart valve, the movement of the device to the implantation position may be impeded or obstructed by the native heart structure. For example, the articulation portion of the implantable device or implant (such as the paddle portion of the anchor used to fix the device to the native heart valve tissue) may be rubbed, temporarily caught, or temporarily blocked by the chordae tendineae CT (shown in FIGS. 3 and 4) extending to the valve leaflets. Exemplary implantable devices or implants can be configured to reduce the likelihood that the device or implant will be temporarily caught or blocked by the CT. For example, an implantable device or implant can be configured to actively or passively constrict to reduce the width of the paddle frame at the anchor portion of the device, and as a result, reduce the surface area of the device, allowing the device / implant to move over and / or through the CT in a variety of different configurations.

[0143] Referring to FIGS. 57-68, various configurations of an implantable device or implant 400 are shown. The device / implant 400 is configured to be more easily maneuvered into a position for implantation within the heart, for example, by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device / implant 400. The device / implant 400 can include any other features related to implantable devices or implants as described in this application or as described in applications or patent documents incorporated herein by reference, and the device 400 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any device or implant described herein can incorporate the features of the device / implant 400.

[0144] The device / implant 400 can include a junction portion or junction portion 404 and an anchor portion 406. The anchor portion can include two or more anchors 408. In some implementations, the junction portion 404 can optionally include one or more junction elements 410 (e.g., spacers, junction elements, gap fillers, etc.). The spacers, junction elements, junction elements, etc. 410 can take any suitable form, such as any form described in this application.

[0145] Each of the anchors 408 includes a plurality of paddles 420 (e.g., three in each of the illustrated embodiments) and one or more clasps 430 (e.g., three in the illustrated embodiments shown in FIGS. 57-59). The clasps 430 can take any suitable form, such as any form described in this application.

[0146] In the illustrated embodiments, anchors 408 each including three paddles 420 are shown, but it will be understood that the anchors 408 can include any suitable number of paddles 420, such as two or more paddles, three or more paddles, four or more paddles, five or more paddles, etc.

[0147] In some implementations, each of the anchors 408 can include a clasp 430 corresponding to each of the paddles 420 (as shown in FIGS. 57-59), or each anchor 408 can include only a single clasp 430 corresponding to only a single paddle of a plurality of paddles 420 (e.g., as shown in FIGS. 60-68). However, it will be understood that each anchor 408 can include any number of paddles 420 that include a corresponding clasp 430 and any number of paddles 420 that do not include a corresponding clasp 430.

[0148] The joining element 410 and the anchor 408 can be joined in various ways. For example, as shown in the illustrated example, the joining element 410 and the anchor 408 can be joined to each other, optionally, by integrally forming the joining element 410 and the anchor 408 as a single integral component. This can be accomplished, for example, by forming the joining element 410 and the anchor 408 from a continuous strip of braided material or woven material such as braided or woven nitinol wire. In some implementations, the plurality of components are formed individually and attached to each other.

[0149] The device or implant 400 can also include an attachment portion 405 for attaching the device 400 to a delivery system 402 (Figs. 69 - 73). The delivery system 402 can be the same as or similar to other delivery systems described herein, such as 102, 202, etc., and can comprise one or more of a catheter, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, pathway, combinations thereof, etc. The attachment portion 405 can include a proximal collar 411 for engaging the delivery system 402 (e.g., with respect to the implant catheter of the delivery system). For example, the proximal collar 411 can be configured to engage a capture mechanism of the delivery system 402 (e.g., the capture mechanism 213 shown in Figs. 43 - 49) (e.g., the capture mechanism of the implant catheter).

[0150] The anchor 408 is configured to allow for easier maneuvering of the device or implant 400 into position within the heart by reducing contact and / or friction between the native structure of the heart, such as a cord, and the anchor 408. The anchor 408 includes a plurality of paddles 420 such that one or more gaps G are formed between the paddles 420. Contact between the native structure of the heart and the anchor 408 is reduced because the native structure of the heart can extend into the gap G as the device 400 is moved through the heart. This allows for easier maneuvering of the device or implant 400 within the heart. Additionally, the gap G allows the paddles to flex towards each other when in contact with the native structure of the heart, such as a cord. This flexing also allows for easier maneuvering of the device / implant 400 through the heart. The device / implant can also be configured to move the paddles towards each other by opening and closing the paddles 420. This movement of the paddles towards each other can also allow for easier maneuvering of the device / implant 400 through the heart.

[0151] The anchor 408 can have an overall width TW of 4 mm to 20 mm, such as 6 mm to 15 mm, such as 8 mm to 12 mm, such as about 10 mm. Each of the paddles 420 can have a width W of 0.2 mm to 2 mm, such as 0.3 mm to 1.5 mm, such as 0.5 mm to 1 mm. Although each of the paddles 420 is shown as having the same width W, it will be understood that the width W of any paddle 420 may not be equal to the width W of other paddles 420. The ratio of the overall width TW to the width W can be 5 / 1 to 20 / 1, such as 7 / 1 to 15 / 1, such as about 10 / 1. The ratio of the overall width to the sum of the widths W of the paddles 420 can be about 2 / 1 to 15 / 1, such as 3 / 1 to 10 / 1, such as about 4 / 1.

[0152] In the illustrated embodiment, the inner paddle axis IPA of the inner paddles 420 of the plurality of paddles 420 is substantially aligned with the central axis CA of the device 400, and the outer paddle axis OPA of one or more outer paddles 420 extends at an angle α spaced from the inner paddle axis IPA of the inner paddles 420. The angle α can be 5 degrees to 60 degrees, such as 15 degrees to 45 degrees, such as 20 degrees to 35 degrees.

[0153] Referring to FIGS. 57 to 62, each of the paddles 420 has a length L of 6 mm to 18 mm, such as 8 mm to 16 mm, such as 10 mm to 14 mm, such as about 12 mm. Although each of the paddles 420 is shown as having the same length L, it will be understood that the length L of any paddle 420 may not be equal to the length L of other paddles (see, for example, FIGS. 63 to 68).

[0154] Figures 60-62 illustrate exemplary implementations of the implantable device or implant 400 shown in FIGS. 57-59. In this example, the device or implant 400 is the same as the example shown in FIGS. 57-59, except that each anchor 408 includes only a single clasp 430 connected to one of the plurality of paddles 420. In the illustrated embodiment, the clasp 430 is connected to the inner paddle 420 of each anchor 408, and the outer paddle of each anchor 408 does not include a corresponding clasp. In some implementations, each of the outer paddles 420 can include a corresponding clasp 430, and the inner paddles 420 may not include a corresponding clasp. It will be understood that any number of paddles 420 can include a corresponding clasp 430 and any number of paddles 420 may not include a corresponding clasp 430.

[0155] Figures 63-65 illustrate exemplary implementations of the implantable device or implant 400 shown in FIGS. 60-62. In this example, the device 400 is the same as the example shown in FIGS. 60-62, except that the inner paddle 420 of each anchor 408 has a length IL that is longer than the length OL of the outer paddle 420. The length IL can be, for example, 8 mm to 16 mm, such as 10 mm to 14 mm, such as about 12 mm, 6 mm to 18 mm. The length OL can be, for example, 6 mm to 14 mm, such as 8 mm to 12 mm, such as about 10 mm, 4 mm to 16 mm. The ratio of the length IL to the length OL can be, for example, 8 / 7 to 3 / 2, such as about 6 / 5, 10 / 9 to 2 / 1.

[0156] Figures 66-68 illustrate exemplary implementations of the implantable device or implant 400 shown in Figures 60-62. In this example, the device 400 is the same as the example shown in Figures 60-62, except that the inner paddle 420 of each anchor 408 has a length IL that is shorter than the length OL of the outer paddle 420. The length OL can be, for example, from 6 mm to 18 mm, such as from 8 mm to 16 mm, such as from 10 mm to 14 mm, such as about 12 mm. The length IL can be, for example, from 4 mm to 16 mm, such as from 6 mm to 14 mm, such as from 8 mm to 12 mm, such as about 10 mm. The ratio of the length OL to the length IL can be, for example, from 10 / 9 to 2 / 1, such as from 8 / 7 to 3 / 2, such as about 6 / 5.

[0157] In the embodiments shown in Figures 63-68, each anchor 408 having a single clasp 430 corresponding to the inner paddle 420 is illustrated, although each paddle 420 of the anchor 408 can include the corresponding clasp 430 (e.g., as shown in Figures 57-59), or it will be understood that any number of paddles 420 can include the corresponding clasp 430 and any number of paddles 420 may not include the corresponding clasp 430.

[0158] Referring to Figures 69-73, the device 400 is shown at various stages during deployment from the delivery system 402. The delivery system 402 can take any suitable form, such as any form described in this application. Although the embodiment of the device / implant 400 illustrated in Figures 57-59 is shown with reference to Figures 69-73, it will be understood that the deployment of the device / implant 400 from the delivery system 402 is also applicable to the embodiments of the device / implant 400 shown in Figures 60-68.

[0159] Referring to FIG. 69, the device / implant 400 is shown in a compressed position within the delivery system 402. The engagement element 410 and the paddles 420 are made of a compressible material that allows the device 400 to assume a compressed position as the device 400 is moved to a desired location within the patient's heart. While the device / implant 400 is positioned within the delivery system 402, the capture mechanism 413 is connected to the collar 411 of the device / implant 400 until the device / implant 400 is deployed from the delivery system 402 and implanted onto a native heart valve (e.g., native mitral valve, native tricuspid valve, etc.).

[0160] FIG. 70 shows the device or implant 400 in a deployed closed position. Upon deployment of the device / implant 400 from the delivery system 402, the engagement element 410 expands in an outward direction M, and the outer paddles 420 of each anchor 408 pivot or articulate outwardly in a direction N to a normal position, thereby creating a gap G (FIGS. 57 and 59) between the inner paddle 420 and each outer paddle 420.

[0161] The actuating shaft 412 extends from the delivery system 402 to engage the paddles 420 and move the paddles 420 from a closed position to an open position. Referring to FIG. 71, by moving the actuating shaft 412 in a direction Y, the actuating shaft 412 engages the paddles 420 and provides a force to the paddles 420 to move the paddles 420 in an outward direction X to an open position. That is, the paddles 420 can be pivotally or flexibly connected to the engagement element 410 at the connection point 470 such that when a force is provided to the paddles 420, the paddles 420 can pivot, bend, and / or articulate outwardly with respect to the engagement element 410. Referring again to FIG. 71, the clasp 430 is maintained in an open position with respect to the paddles 420 by applying a tension F to the corresponding actuating line 416 onto the clasp 430 such that a tissue capture region exists between the paddles 420 and the clasp 430.

[0162] Referring to FIG. 72, after the valve tip tissue is positioned within the tissue capture region between the clasp 430 and the paddle 420, the clasp 430 is moved in the Z direction to capture the tissue and fix the device 400 to the tissue. The clasp 430 can be biased towards the closed position so that the clasp 430 can be moved to the closed position by releasing the tension F (FIG. 71) from the activation line 416, or the user can actively control the activation line 416 to move the clasp 430 to the closed position.

[0163] Referring to FIG. 73, after the device 400 is fixed to the valve tip tissue by the paddle 420 and the clasp 430, the activation shaft 412 is disengaged from the paddle 420 and retracted into the delivery system 402, whereby the paddle 420 is moved back to its normally closed position. After the device 400 is fixed to the tissue and further the anchor 408 is in the closed position, the capture mechanism 413 is removed from the collar 411 so that the device 400 is no longer attached to the delivery system 402, and the delivery system 402 can be removed from the patient.

[0164] Referring to FIGS. 74 - 85, various configurations of an implantable device or implant 500 are shown. The device or implant 500 is configured to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device or implant 500 and natural structures of the heart, such as cords. The device or implant 500 can include any other features related to implantable devices or implants, as described in this application or as described in applications or patent documents incorporated herein by reference. The device 500 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any device or implant described herein can incorporate the features of the device / implant 500.

[0165] The implantable device or implant 500 includes a junction portion 504, a proximal or attachment portion 505, an anchor portion 506, and a distal portion 507. In some implementations, the junction portion 504 includes a junction element 510 (e.g., a spacer, a healing element, a gap filler, etc.) that can be used, for example, to be implanted between the valve leaflets 20, 22 in the native mitral valve MV. The junction element 510 can take any suitable form, such as any form described in this application. The attachment portion 205 includes a first collar or proximal collar 511 for engaging a capture mechanism 513 of a delivery sheath or delivery system 202 (see FIGS. 86A, 86B, 87A, 87B, 88, and 89). The proximal collar 511 can take any suitable form, such as any form described in this application.

[0166] The anchor portion 506 can include two or more anchors 508, and each anchor 508 includes a plurality of paddle members 519 (e.g., three in each of the illustrated embodiments) and one or more clasps 530 (e.g., three in the illustrated examples shown in FIGS. 74 - 76). The clasp 530 can take any suitable form, such as any form described in this application. The distal portion 507 includes a cap 514 attached to the paddle member 519 such that moving the cap 514 can move the paddle member 519 between an open position and a closed position. The cap 514 can take any suitable form, such as any form described in this application.

[0167] Each paddle member 519 can include an outer paddle 520 and an inner paddle 522. The paddle member 519 can be formed of, for example, a metallic cloth such as mesh, a woven fabric, a braid, or any other suitable manner, or a flexible material cut by laser cutting or other means. The material can be a cloth, a shape memory alloy wire such as nitinol, or any other flexible material suitable for implantation into the human body to provide shape setting ability. In some implementations, the paddle member 519 further includes a paddle frame (not shown) that supports the inner paddle 522 and the outer paddle 520. The paddle frame can take any suitable form, such as any form of the paddle frame described in this application.

[0168] The joining element 510 is optional. In the illustrated embodiment, the joining element 510 and the paddle member 519 are formed from a continuous strip of material. The material can be, for example, any material described in this application with respect to the paddle member 519. In some implementations, the plurality of components are formed individually and attached to each other. The joining element 510 extends from the proximal collar 511 to the inner paddle 522.

[0169] The engagement element 510 has an overall elongated and rounded shape. In particular, the engagement element 510 has an elliptical shape or cross-section when viewed from above (e.g., as shown in FIG. 74), a tapered shape or cross-section when viewed in a front view (e.g., as shown in FIG. 75), and a rounded shape or cross-section when viewed in a side view (e.g., as shown in FIG. 76). This combination of these three geometries can result in the three-dimensional shape of the illustrated engagement element 510 that achieves the advantages described herein.

[0170] In the illustrated embodiment, an anchor 508 is shown that includes three paddle members 519 each, although it will be understood that the anchor 508 can include any suitable number of paddle members 519, such as two or more paddle members, three or more paddle members, four or more paddle members, five or more paddle members, etc. Additionally, each of the anchors 508 can include a clasp 530 corresponding to each of the paddle members 519 (as shown in FIGS. 74-76), or each anchor 508 can include only a single clasp 530 corresponding to only a single one of the paddle members of the plurality of paddle members 519 (e.g., as shown in FIGS. 77-79). However, it will be understood that each anchor 508 can include any number of paddle members 519 that include corresponding clasps 530 and any number of paddle members 519 that do not include corresponding clasps 530.

[0171] The anchor 508 is configured to more easily maneuver the device 500 into a position for implantation within the heart by reducing contact and / or friction between the native structure of the heart, such as a cord, and the anchor 508. The anchor 508 includes a plurality of paddles 520 such that one or more gaps G are formed between the paddles 520. Contact between the native structure of the heart and the anchor 508 is reduced because the native structure of the heart can extend into the gap G when the device 500 is moved through the heart. Thereby, the device 500 can be more easily maneuvered within the heart. Additionally, the gap G allows the paddles to flex towards each other when contacting the native structure of the heart, such as a cord, and the anchor 508. This flexing also allows the device 500 to be more easily maneuvered through the heart. The device can also be configured to move the paddles 520, 522 towards each other by opening and closing the paddles. This movement of the paddles towards each other also allows the device 500 to be more easily maneuvered through the heart.

[0172] The anchor 508 can have an overall width TW of 4 mm to 20 mm, such as 6 mm to 15 mm, such as 8 mm to 12 mm, such as about 10 mm. Each of the paddles 519 can have a width W of 0.2 mm to 2 mm, such as 0.3 mm to 1.5 mm, such as 0.5 mm to 1 mm. Although each of the paddles 519 is shown as having the same width W, it will be understood that the width W of any paddle 519 may not be equal to the width W of other paddles 519. The ratio of the overall width TW to the width W can be 5 / 1 to 20 / 1, such as 7 / 1 to 15 / 1, such as about 10 / 1. The ratio of the overall width to the sum of the widths W of the paddles 519 can be about 2 / 1 to 15 / 1, such as 3 / 1 to 10 / 1, such as about 4 / 1.

[0173] Referring to FIGS. 74-79, each of the inner paddles 522 has a length L of 6 mm to 18 mm, such as 8 mm to 16 mm, such as 10 mm to 14 mm, such as about 12 mm. Although each of the inner paddles 522 is shown as having the same length L, it will be appreciated that the length L of any one inner paddle 522 may not be equal to the length L of other inner paddles (see, for example, FIGS. 63-68).

[0174] FIGS. 77-79 illustrate an embodiment of the implantable device or implant 500 shown in FIGS. 74-76. In this embodiment, the device 500 is identical to the embodiment shown in FIGS. 74-76, except that each anchor 508 includes only a single clasp 530 attached to one of the plurality of paddle members 519. In the illustrated embodiment, the clasp 530 is aligned with one of the centers in the inner paddle 522 of each anchor 508, and the outer ones in the inner paddle members 522 do not include corresponding clasps. In some implementations, the outer ones in the paddle members 519 can include corresponding clasps 530, and the inner ones in the paddle members 519 may not include corresponding clasps. It will be appreciated that any number of the paddle members 519 may include corresponding clasps 530, and any number of the paddle members 519 may not include corresponding clasps 530.

[0175] Figures 80 to 82 illustrate exemplary implementation forms of the embedded device or implant 500 shown in Figures 77 to 79. In this embodiment, the device / implant 500 is the same as the embodiment shown in Figures 77 to 79, except that the inner part of the paddle 519 of the anchor 508 has a length IL that is greater than the length OL of the outer part of the paddle 519. The length IL can be, for example, 8 mm to 16 mm, such as 10 mm to 14 mm, such as about 12 mm, 6 mm to 18 mm. The length OL can be, for example, 6 mm to 14 mm, such as 8 mm to 12 mm, such as about 10 mm, 4 mm to 16 mm. The ratio of the length IL to the length OL can be, for example, 8 / 7 to 3 / 2, such as about 6 / 5, 10 / 9 to 2 / 1.

[0176] Figures 83 to 85 illustrate exemplary implementation forms of the embedded device or implant 500 shown in Figures 77 to 79. In this example, the device 500 is the same as the example shown in Figures 77 to 79, except that the inner paddle member 522 of each anchor 508 has a length IL that is shorter than the length OL of the outer paddle member 520. The length OL can be, for example, 8 mm to 16 mm, such as 10 mm to 14 mm, such as about 12 mm, 6 mm to 18 mm. The length IL can be, for example, 6 mm to 14 mm, such as 8 mm to 12 mm, such as about 10 mm, 4 mm to 16 mm. The ratio of the length OL to the length IL can be, for example, 8 / 7 to 3 / 2, such as about 6 / 5, 10 / 9 to 2 / 1.

[0177] In the examples shown in Figures 80 to 85, each anchor 508 having a single clasp 530 corresponding to the inner paddle member 522 is illustrated. However, it should be understood that each paddle member 519 of the anchor 508 may include the corresponding clasp 530 (for example, as shown in Figures 74 to 76), or any number of paddle members 519 may include the corresponding clasp 530 and any number of paddle members 519 may not include the corresponding clasp 530.

[0178] Referring to FIGS. 86A, 87A, and 88-90, device or implant 500 is shown at various stages during deployment from delivery system 502. Delivery system 502 can take any suitable form and can be the same as or similar to other delivery systems herein, such as 102, 202, 402, etc., and can further comprise one or more of a catheter, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, pathway, combinations thereof, etc. Although the examples of device or implant 500 illustrated in FIGS. 74-76 are shown with reference to FIGS. 86A, 87A, and 88-90, it will be understood that the deployment of device / implant 500 from delivery system 502 is also applicable to the examples of device / implant 500 shown in FIGS. 77-85.

[0179] Referring to FIG. 86A, device or implant 500 is shown in a compressed position within delivery system 502. Joining element 510 and paddle member 519 are made of a compressible material that allows device 500 to be in a compressed position as device 500 is moved to a desired location within a patient's heart. While device 500 is located within delivery system 502 and also until device 500 is implanted onto the native mitral valve MV (or other native heart valve) after device 500 is deployed from delivery system 502, capture mechanism 513 is connected to collar 511 of device 500.

[0180] FIG. 87A shows device 500 in a deployed closed position. Upon deployment of device 500 from delivery system 502, joining element 510 expands in an outward direction M, and the outer member 520 of each anchor 508 pivots outwardly in a direction N to a normal position, whereby a gap G (FIGS. 74 and 76) is assumed to exist between inner paddle member 522 and each outer paddle member 520.

[0181] FIG. 86B shows an embodiment similar to the embodiment of FIG. 86A, where the paddle member 519 is in the extended position inside the delivery system 502. As a result, since the paddle is not disposed around the outside of the engagement element 510, compared with the example of FIG. 86A, the device / implant 500 can be compressed to a smaller size. Consequently, in the embodiment illustrated in FIG. 86B, by using a smaller delivery system 502 (compared with the delivery system used in the embodiment illustrated in FIG. 86A), a device of the same size can be delivered.

[0182] FIG. 87B shows the device or implant 500 configured as in FIG. 86B being withdrawn from the delivery system 502. When the device / implant 500 is deployed from the delivery system 502, the engagement element 510 expands in the outward direction M, and the paddle member 519 remains in the extended state. After being withdrawn from the delivery system, the paddle member 519 can be closed (i.e., can move to the position illustrated in FIG. 87A).

[0183] An actuating element 512 (e.g., an actuating wire, an actuating shaft, etc.) extends from the delivery system 502 to engage with the cap 514 and move the paddle member 519 from the closed position to the open position. Referring to FIG. 88, by moving the actuating element 512 to engage with the cap 514 and moving the cap 514 in the direction Y, the paddle member 519 is moved in the outward direction X to the open position (e.g., similar to the engagement between the actuating element 212 and the cap 214 for moving the anchor 208 shown in FIGS. 22 - 37). The clasp 530 is maintained in the open position with respect to the paddle member 519 by applying a tension F to the corresponding actuating line 516 on the clasp 530 such that the tissue capture region exists between the paddle member 519 and the clasp 530.

[0184] Referring to FIG. 89, after the valve tip tissue is positioned within the tissue capture region between the clasp 530 and the paddle member 519, the clasp 530 is moved in the Z direction to capture the tissue and fix the device / implant 500 to the tissue. The clasp 530 can be biased towards the closed position such that the clasp 530 can be moved to the closed position by releasing the tension F (FIG. 88) from the actuation line 516, or the actuation line 516 can be actively controlled by the user to move the clasp 530 to the closed position.

[0185] Referring to FIG. 90, after the device or implant 500 is fixed to the valve tip tissue by the paddle member 519 and the clasp 530, the actuating element 512 moves the paddle member 519 to the closed position by moving the cap 514 back in the D direction to the normal position. Further, the actuating element 512 is detached from the cap 514 and retracted into the delivery system 502. After the device 500 is fixed to the tissue and the anchor 508 is in the closed position, the capture mechanism 513 is removed from the collar 511 so that the device 500 is no longer attached to the delivery system 502, and the delivery system 502 can be removed from the patient.

[0186] Referring to FIGS. 91 - 95, an exemplary implementation of an implantable device or implant 600 (FIG. 94) includes an anchor portion 606 having one or more paddle frames 624. The paddle frames 624 are configured to more easily maneuver the device or implant 600 into position for implantation within the heart, for example, by reducing contact and / or friction between the natural structures of the heart, such as cord-like structures, and the device 600. That is, the paddle frames 624 are configured to move between an expanded position (when the device 600 is in the closed position) and a constricted position (when the device 600 is in the open position), and when the paddle frames 624 are in the constricted position, contact between the natural structures of the heart and the device 600 is reduced. The device or implant 600 can include any other features for implantable devices or implants contemplated in this application or in applications and patents incorporated herein by reference, and the device 600 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any device or implant described herein can incorporate the features of the device or implant 600.

[0187] Referring to FIG. 94, the device or implant 600 includes a junction portion 604, a proximal or attachment portion 605, an anchor portion 606, and a distal portion 607. The junction portion 604, the attachment portion 605, and the distal portion can take any suitable form, such as, for example, the form of these portions in the device 200 shown in FIGS. 22 - 37, or any other form described in this application. In some implementations, the junction portion 604 optionally includes a junction element 610 (e.g., a spacer, a healing element, a gap filler, etc.) that can be used, for example, to be implanted between the valve leaflets 20, 22 in the native mitral valve MV. The junction element 610, such as, can take any suitable form, such as any form described in this application.

[0188] The attachment portion 605 includes a first or proximal collar 611 for engaging with a delivery sheath or a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 44-49) of a delivery system (e.g., delivery system 202 shown in FIGS. 38-49). The proximal collar 611 can take any suitable form, such as any form described in this application, for example.

[0189] The distal portion 607 includes a cap 614 attached to the anchor 608 of the anchor portion 606 such that by moving the cap 614, the anchor 608 can be moved between an open position and a closed position. The cap 614 can take any suitable form, such as any form described in this application, for example. The cap 614 can be moved (e.g., as described in this application with respect to the device 200 and the actuating element 212 shown in FIGS. 22-37) by extending and retracting an actuating element 612 such as an actuating wire or an actuating shaft.

[0190] The anchor portion 606 of the device 600 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in FIGS. 22-37 (except that the paddle frame 224 is replaced by a paddle frame 624 as shown in FIGS. 91-95 and described in more detail below), or any other form described in this application that can include a paddle frame 624, for example. The anchor portion 606 can include a plurality of anchors 608, and each anchor 608 includes an outer paddle 620, an inner paddle 622, a paddle extension member or paddle frame 624, and a clasp (e.g., clasp 230 shown in FIGS. 22-37).

[0191] The outer paddle 620 is attachable to the inner paddle 622 and to the cap 614 of the distal portion 607 by a connection portion 623, and the inner paddle 622 is attachable to the joining element 610. Thus, the anchor 608 is configured similarly to a leg in that the inner paddle 622 is like the upper portion of the leg, the outer paddle 620 is like the lower portion of the leg, and the connection portion 623 is like the knee portion of the leg.

[0192] The paddle frame 624 has a first connecting member 601 (Figs. 91 and 95) for attaching the paddle frame 624 to the cap 614 at the distal portion 607 such that the paddle frame 624 is fixedly connected to the cap 614. The connecting member 601 can be, for example, a notch that engages a corresponding notch in the cap. The paddle frame 624 has one or more second connecting members 603 (Figs. 91 and 95) that connect to the connection portion 623 between the inner paddle 622 and the outer paddle 620 such that the paddle frame 624 is fixedly connected to the anchor 608. The connecting member 603 can be, for example, a stop that allows the paddle frame 624 to be sewn to the cover and also allows the paddle frame 624 to be sewn to the inner and outer paddles 622, 620. In some implementations, the paddle frame 624 is formed from a more rigid and harder material compared to the material forming the paddles 622, 620 such that the paddle frame 624 provides support for the paddles 622, 620.

[0193] The paddle frame 624 provides additional clamping force between the inner paddle 622 and the joining element 610. The paddle frame assists in wrapping the valve tip around the perimeter of the side surface of the joining element 610 for better sealing between the joining element 610 and the valve tip. That is, the paddle frame 624 can be configured to have a round three-dimensional shape that extends from the cap 614 to the connection portion 623 of the anchor 608. The connections between the paddle frame 624, the outer paddle 620 and the inner paddle 622, the cap 614, and the joining element 610 can restrict the movement of each of these parts (e.g., to the movements and positions described with reference to FIGS. 22 - 37). In particular, the connection portion 623 is restricted by its connection between the outer paddle 620 and the inner paddle 622 and by its connection to the paddle frame 624. Similarly, the paddle frame 624 is restricted by its attachment to the connection portion 623 (and thus the inner paddle 622 and the outer paddle 620) and by its attachment to the cap 614.

[0194] By configuring the paddle frame 624 in this way, the surface area is increased compared to the inner paddle 622 alone. This can, for example, make it easier to grip and fix the native valve tip. The increased surface area can also disperse the clamping force of the paddles 620 and the paddle frame 624 against the native valve tip over a relatively large surface of the native valve tip to further protect the native valve tip tissue. In some implementations, the increased surface area of the paddle frame 624 can also enable clamping the native valve tip against the implantable device or implant 200 such that the native valve tip fully joins around the joining element 610. This can, for example, improve the sealing of the native valve tip and thus prevent or further reduce mitral regurgitation.

[0195] The paddle frame 624 is configured to move between an expanded position (e.g., as shown in FIG. 91) and a constricted position (e.g., as shown in FIGS. 92 and 95). When in the expanded position, the paddle frame 624 has an increased surface area that provides the aforementioned advantages for fixing the device 600 to the native valve of the heart. When in the constricted position, the paddle frame 624 has a reduced width compared to the paddle frame in the expanded position, thereby allowing the device 600 to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the native structures of the heart, such as cords, and the device 600. Moving the anchor 608 between an open position and a closed position moves the paddle frame 624 between the expanded position and the constricted position.

[0196] In the illustrated embodiment, an actuating element 612 (e.g., an actuating wire, an actuating shaft, etc.) extends from a delivery system (e.g., any delivery system described in this application) and engages the cap 614 to move the cap 614 in the direction Y relative to the joining element or spacer 610, thereby enabling movement of the device 600. The actuating element 612 can engage the cap and move the cap by any suitable means, such as any means provided in this application. Moving the cap 614 away from the joining element 610 moves the anchor 608 to the open position (as shown in FIG. 94), and moving the joining element 610 toward the joining element 610 moves the anchor to the closed position.

[0197] Based on the configuration of the paddle frame 624 and the connection of the paddle frame 624 to the cap 614 and the connection portion 623 of the anchor 608, the paddle frame 624 is in an extended position when the anchor 608 is in the closed position and in a constricted position when the anchor 608 is in the open position. That is, referring to FIG. 91, when the anchor 608 is moved to the open position, since the cap 614 is moved away from the engaging element 610 in the direction Y (FIG. 94), and since the paddle frame 624 is fixedly connected to the cap 614 and to the connection portion 623 of the anchor 608, a tension F is applied to the paddle frame 624.

[0198] Referring to FIGS. 91 and 92, the paddle frame 624 has a width W and a thickness T greater than the width W. Since the thickness T is greater than the width W, when a tension F is applied to the paddle frame 624, the degree to which the paddle frame 624 is compressed in the direction X increases. This is because the stiffness of the paddle frame in the direction of the width W is smaller than the stiffness in the direction of the thickness T. In some implementations, the ratio of the thickness T to the width W is, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, 10 / 9 to 3 / 1.

[0199] Referring to FIG. 95, when in the constricted position, the paddle frame 624 has a length L2 and an overall width W2. The length L2 can be, for example, 12 mm to 18 mm, for example, about 15 mm, 9 mm to 21 mm. The width W2 can be, for example, 5 mm to 10 mm, for example, 7 mm to 9 mm, for example, about 8 mm, 3 mm to 12 mm. The ratio of the overall width (not shown) of the paddle frame 624 in the extended position to the overall width W2 can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, 10 / 9 to 3 / 1. The ratio of the length (not shown) of the paddle frame 624 in the extended position to the length L2 of the paddle frame 624 can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, 10 / 9 to 3 / 1.

[0200] Referring to FIG. 93, paddle frame 624 is shown in a compressed position inside delivery system 602. Delivery system 602 can take any suitable form and can be the same as or similar to other delivery systems herein, such as, for example, 102, 202, 402, 502, etc., and can further include one or more of a catheter, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, path, combinations thereof, etc. The configuration of paddle frame 624 enables the paddle frame to more easily maintain the compressed position inside delivery system 602. That is, since paddle frame 624 has a thickness T (FIG. 91) that is greater than its width W (FIG. 91), paddle frame 624 can be more easily compressed because the stiffness of the paddle frame in the direction of width W is less than the stiffness in the direction of thickness T.

[0201] Referring to FIGS. 96 - 98, 101, and 104, an embodiment of paddle frame 724 for an implantable device or implant (e.g., device 200 shown in FIGS. 22 - 37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 785, a first connection member 701 for attachment to a cap of the implantable device or implant, a second connection member 703 for attachment to an anchor of the device, and a transition section 771 located between the first connection member 701 and the main support section 785. Paddle frame 724 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91 - 95), or the width can be greater than the thickness.

[0202] The connecting member 701 of the paddle frame 724 includes an extension portion 773 configured to connect the paddle frame 724 to a cap by extending into a cap of an implantable device or implant. In this example, the outer surface 775 of the main support section 785, the outer surface 777 of the transition section 771, and the outer surface 779 of the connecting member 701 are substantially aligned such that each of these outer surfaces faces the same direction Z (FIG. 104).

[0203] Referring to FIG. 98, the paddle frame 724 is shown in a closed position relative to a bonding element or spacer 710 of an implantable device or implant. Referring to FIGS. 101 and 104, the paddle frame is shown in an open position relative to the bonding element 710. The bonding element 710 can take any suitable form, such as any of the forms described in this application.

[0204] Referring to FIGS. 99, 102, and 105, an example of a paddle frame 824 for an implantable device or implant (e.g., device 200 shown in FIGS. 22 - 37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 885, a first connecting member 801 for attachment to a cap of the implantable device or implant, a second connecting member (e.g., connecting member 603 shown in FIG. 91) for attachment to an anchor of the device, and a transition section 871 located between the first connecting member 801 and the main support section 885. The paddle frame 824 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91 - 95), or the width can be greater than the thickness.

[0205] The connecting member 801 of the paddle frame 824 includes an extension portion 873 configured to connect the paddle frame 824 to a cap by extending into a cap of an implantable device or implant. In this example, the outer surface 879 of the connecting member 801 is disposed at an angle of approximately 45 degrees from the outer surface 875 of the main support section 885 such that the transition portion 871 is twisted about its axis.

[0206] The paddle frame can be shaped with the twists illustrated in FIGS. 99 and 102. In some implementations, the paddle frame can be shaped in the shapes shown in FIGS. 96, 98, and 101, and the connecting member 801 can be twisted to the positions illustrated in FIGS. 99 and 102 and held in the twisted direction by attachment to the cap. In some implementations, the paddle frame 824 can be shaped with the connecting member 801 set to the positions illustrated in FIGS. 99 and 102, but can be shaped in a twisted state that returns to the positions illustrated in FIGS. 96, 98, and 101 by connection to the cap.

[0207] Referring to FIG. 99, the paddle frame 724 is shown in a closed position relative to a bonding element or spacer 810 of an implantable device or implant. Referring to FIGS. 102 and 105, the paddle frame is shown in an open position relative to the bonding element 810. The bonding element 810 can take any suitable form, such as any of the forms described in this application, for example.

[0208] Due to the angle between the outer surface 879 of the connecting member 801 and the outer surface 875 of the main support section 885 (and the corresponding twisted transition portion 871), when the paddle frame is moved from the closed position to the open position, torque increases within the material forming the paddle frame 824 and stress is generated within the material. This increase in torque and generation of stress within the material forming the paddle frame is due to the paddle frame being fixedly connected to both the inner paddle and the outer paddle (at the transition portion between the two) and to the cap of the implantable device or implant. When the cap pulls on the outer paddle, the twist of the transition portion 871 spreads along the length of the paddle frame. As a result, the paddle frame 824 becomes narrower when the cap pulls the paddle to the open position as compared to a paddle frame that does not include the twisted translation portion 871. This additional decrease in the width of the paddle frame allows the implantable device or implant to be more easily maneuvered into a position for implantation within the heart, for example, by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device.

[0209] In the illustrated embodiment, although it is shown that the outer surface 879 is disposed at an angle of approximately 45 degrees from the outer surface 875, it will be understood that the outer surface 879 can be disposed at any other suitable angle relative to the outer surface 875 such that it moves with torque to a narrower position when the paddle frame is moved from the closed position to the open position (as compared to a paddle frame that does not have a twisted translation portion).

[0210] Generally, the greater the amount of twist, the greater the torque and stress generated, and the greater the narrowing of the paddle. For example, in FIGS. 100, 103, and 106, embodiments of the paddle frame 924 have a 90-degree twist. In the embodiments illustrated in FIGS. 100, 103, and 106, an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 985, a first connection member 901 for attachment to the cap of the implantable device or implant, a second connection member (e.g., connection member 603 shown in FIG. 91) for attachment to the anchor of the device, and a transition section 971 located between the first connection member 901 and the main support section 985. The paddle frame 924 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0211] The connection member 901 of the paddle frame 924 includes an extension portion 973 configured to connect the paddle frame 924 to the cap by extending into the cap of the implantable device or implant. In this example, the outer surface 979 of the connection member 901 is disposed at an angle of approximately 90 degrees from the outer surface 975 of the main support section 985 such that the transition section 971 is twisted about its axis.

[0212] The paddle frame can be shaped to have the twists illustrated in FIGS. 100 and 103. In some implementations, the paddle frame can be shaped in the shapes shown in FIGS. 96, 98, and 101, and the connecting member 901 can be twisted to the positions illustrated in FIGS. 100 and 103 and held in the twisted direction by attachment to the cap. In some implementations, the paddle frame 924 can be shaped with the connecting member 901 set to the positions illustrated in FIGS. 100 and 103, but can be shaped in a twisted state to return to the positions illustrated in FIGS. 96, 98, and 101 by connection to the cap.

[0213] Referring to FIG. 100, the paddle frame 924 is shown in the closed position relative to the bonding element or spacer 910 of the implantable device or implant. Referring to FIGS. 103 and 106, the paddle frame is shown in the open position relative to the bonding element 910. The bonding element 910 can take any suitable form, such as any form described in this application, for example.

[0214] Due to the angle between the outer surface 979 of the connecting member 901 and the outer surface 975 of the main support section 985 (and the corresponding twisted transition portion 971), when the paddle frame is moved from the closed position to the open position, torque increases within the material forming the paddle frame 924 and stress is generated within the material. This increase in torque and generation of stress within the material forming the paddle frame are due to the paddle frame being fixedly connected both to both the inner paddle and the outer paddle (at the transition portion between the two) and to the cap of the implantable device or implant. When the cap pulls on the outer paddle, the twist of the transition portion 971 spreads along the length of the paddle frame. As a result, the paddle frame 924 becomes narrower when the cap pulls the paddle to the open position compared to a paddle frame that does not include the twisted translation portion 971. This additional reduction in the width of the paddle frame allows the implantable device or implant to be more easily maneuvered into position for implantation within the heart, for example, by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device.

[0215] Referring to FIGS. 107 and 108, an example of a paddle frame 1024 for an implantable device or implant (e.g., device 200 shown in FIGS. 22 - 37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1085, a first connecting member 1001 for attachment to the cap of the implantable device or implant, and a second connecting member 1003 for attachment to the anchor of the device. The paddle frame 1024 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91 - 95), or the width can be greater than the thickness.

[0216] The main support section 1085 includes an inner portion 1072 and an outer portion 1074. The inner portion 1072 is connected to the connecting member 1001 at the connection point 1076 and is also connected to the connecting member 1003 at the connection point 1078. The inner portion 1072 is configured to move the paddle frame 1024 from a normal expanded position (FIG. 107) when the anchor of the implantable device or implant is in the closed position to a narrowed position (FIG. 108) when the anchor of the device is moved to the open position. The outer portion 1074 is connected to the inner portion at the connection point 1080, and the outer portion 104 defines the full width of the paddle frame 1024 (e.g., the expanded width EW shown in FIG. 107 and the narrowed width NW shown in FIG. 108).

[0217] In the illustrated embodiment, the inner portion 1072 of the main support section 1085 is diamond-shaped. Referring to FIG. 108, when the anchor of the implantable device or implant is moved to the open position, the paddle frame 1024 is subjected to a tension force F because the paddle frame 1024 is fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension force F applied to the paddle frame 1024 moves the connection points 1076, 1078 in the outward direction OD, thereby moving the connection point 1080 in the inward direction ID. By moving the connection point 1080 in the inward direction ID, the outer portion 1074 is moved in the inward direction ID, whereby the full width of the paddle frame 1024 is moved from the expanded width EW (FIG. 107) to the narrowed width NW (FIG. 108). By moving the paddle frame 1024 to the narrowed position, for example, by reducing the contact and / or friction between the natural structure of the heart, such as a cord, and the device, the implantable device or implant can be more easily maneuvered into position for implantation within the heart.

[0218] The expansion width EW of the paddle frame 1024 can be, for example, 7 mm to 12 mm, for example, 9 mm to 11 mm, for example, about 10 mm, 5 mm to 15 mm. The narrowing width NW of the paddle frame 1024 can be, for example, 5 mm to 10 mm, for example, 7 mm to 9 mm, for example, about 8 mm, 3 mm to 12 mm. The ratio of the expansion width EW to the narrowing width NW can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, 10 / 9 to 3 / 1.

[0219] In the illustrated embodiment, although the inner portion 1072 of the main support section 1085 is shown as being diamond-shaped, it will be understood that the inner portion 1072 can take any form that can move the paddle frame 1024 to the narrowed position when a tension F is applied to the paddle frame 1024, so as to make it possible for the paddle frame to more easily maneuver an implantable device or implant into a position for implantation within the heart.

[0220] Referring to FIGS. 109 and 110, an embodiment of a paddle frame 1124 for an implantable device or implant (e.g., device 200 shown in FIGS. 22 - 37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1185, a first connection member 1101 for attachment to a cap of the implantable device or implant, and a second connection member 1103 for attachment to an anchor of the device. The paddle frame 1124 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91 - 95), or the width can be greater than the thickness.

[0221] The main support section 1185 includes an inner portion 1172 and an outer portion 1174. The inner portion 1172 is connected to the connecting member 1103 at the connection point 1178. The outer portion 1174 is connected to the inner portion 1172 at the connection point 1180, and the outer portion 1174 extends to the connecting member 1101. The outer portion 1174 defines the full width of the paddle frame 1124 (e.g., the extended width EW shown in FIG. 109 and the narrowed width NW shown in FIG. 110). The inner portion 1172 is configured to move the paddle frame 1124 from the normal extended position (FIG. 109) when the anchor of the implantable device or implant is in the closed position to the narrowed position (FIG. 110) when the anchor of the device is moved to the open position.

[0222] In the illustrated embodiment, the inner portion 1172 of the main support section 1185 includes arms 1182 that extend inwardly from the connection point 1180 and converge with each other at the connection point 1178 such that the inner portion 1172 has a triangular shape. Referring to FIG. 110, when the anchor of the implantable device or implant is moved to the open position, the paddle frame 1124 is subjected to a tension force F because the paddle frame 1124 is fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension force F applied to the paddle frame 1124 moves the connection point 1178 and the connecting member 1101 in the outward direction OD, thereby moving the connection point 1080 in the inward direction ID. By moving the connection point 1080 in the inward direction ID, the outer portion 1174 is moved in the inward direction ID, whereby the full width of the paddle frame 1124 is moved from the extended width EW (FIG. 109) to the narrowed width NW (FIG. 110). By moving the paddle frame 1124 to the narrowed position, for example, by reducing the contact and / or friction between the natural structures of the heart, such as cords, and the device, the implantable device or implant can be more easily maneuvered into position for implantation within the heart.

[0223] The expansion width EW of the paddle frame 1124 of the paddle frame 1024 can be, for example, 7 mm to 12 mm, for example, 9 mm to 11 mm, for example, about 10 mm, 5 mm to 15 mm. The narrowing width NW of the paddle frame 1124 can be, for example, 5 mm to 10 mm, for example, 7 mm to 9 mm, for example, about 8 mm, 3 mm to 12 mm. The ratio of the expansion width EW to the narrowing width NW can be, for example, 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2, 10 / 9 to 3 / 1.

[0224] In the illustrated embodiment, although the inner portion 1172 of the main support section 1185 is shown having arms 1182 that extend inwardly from the connection point 1180 and converge with each other at the connection point 1178 such that the inner portion 1172 has a triangular shape, it will be understood that the inner portion 1072 can take any form that can move the paddle frame 1124 to the narrowed position when a tension F is applied to the paddle frame 1124, so as to make it easier to maneuver an implantable device or implant to the position for implantation within the heart.

[0225] In the illustrated embodiment, the inner portion 1172 of the main support section 1185 includes arms 1182 that extend inwardly from connection point 1180 and converge with each other at connection point 1178 such that the inner portion 1172 has a triangular shape. Referring to FIG. 110, when the anchor of the implantable device or implant is moved to the open position, the paddle frame 1124 receives a tension force F because the paddle frame 1124 is fixedly connected to the cap and to the anchor of the device. This tension force F applied to the paddle frame 1124 moves the connection point 1178 and the connecting member 1101 in the outward direction OD, thereby moving the connection point 1180 in the inward direction ID. By moving the connection point 1180 in the inward direction ID, the outer portion 1174 is moved in the inward direction ID, whereby the overall width of the paddle frame 1124 is moved from the expanded width EW (FIG. 109) to the narrowed width NW (FIG. 110). By moving the paddle frame 1124 to the narrowed position, the implantable device or implant can be more easily maneuvered into position for implantation within the heart, for example, by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device.

[0226] Although the inner portion 1172 of the main support section 1185 is shown in the illustrated embodiment as having arms 1182 that extend inwardly from connection point 1180 and converge with each other at connection point 1178 such that the inner portion 1172 has a triangular shape, it will be understood that the inner portion 1172 can take any form that can move the paddle frame 1124 to the narrowed position when a tension force F is applied to the paddle frame 1124, enabling the paddle frame to more easily maneuver the implantable device or implant into position for implantation within the heart.

[0227] Referring to FIG. 111, an example of a paddle frame 1224 for an implantable device or implant (e.g., device 200 shown in FIGS. 22 - 37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1285, a first connection member 1201 for attachment to a cap of the implantable device or implant, and a second connection member 1203 for attachment to an anchor of the device. The paddle frame 1224 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91 - 95), or the width can be greater than the thickness.

[0228] The main support section 1285 includes an inner portion 1272 and an outer portion 1274. The inner portion 1272 is connected to the connection member 1203 at connection point 1278. The outer portion 1274 is connected to the inner portion 1272 at connection point 1280 and extends to the connection member 1201. The outer portion 1274 defines the total width TW of the paddle frame 1224. The inner portion 1272 is configured to move the paddle frame 1224 from a normal expanded position (FIG. 111) when the anchor of the implantable device or implant is in a closed position to a constricted position when the anchor of the device is moved to an open position.

[0229] In the illustrated embodiment, the inner portion 1272 of the main support section 1185 includes an arm 1282 and a rounded member 1284. The arm 1282 extends inwardly from the connection point 1280, and the rounded member 1284 is connected to each of the arms 1282 and is also connected to the connection point 1278. When the anchor of the implantable device or implant is moved to the open position, the paddle frame 1224 is subjected to a tension (e.g., the tension F shown in FIGS. 108 and 110) because the paddle frame 1224 is fixedly connected to the cap and to the anchor of the device. This tension F applied to the paddle frame 1224 moves the connection point 1278 and the connecting member 1201 outwardly, thereby moving the connection point 1280 inwardly. By moving the connection point 1280 inwardly, the outer portion 1274 is moved inwardly, whereby the overall width TW of the paddle frame 1224 is moved to the constricted position, thereby making it easier to maneuver the implantable device or implant into a position for implantation within the heart by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device.

[0230] When in the normal expanded position, the overall width TW of the paddle frame 1224 can be, for example, 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The constricted width of the paddle frame 1124 can be, for example, 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as about 8 mm. The ratio of the overall width TW to the constricted width can be, for example, 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2, 10 / 9 to 3 / 1.

[0231] In the illustrated embodiment, an inner portion 1272 of the main support section 1285 is shown having an arm 1282 that extends inwardly from connection point 1280 and is connected to a round member 1284 that is connected to connection point 1278. However, it will be appreciated that the inner portion 1272 can take any form that can move the paddle frame 1224 to a constricted position when a tension F is applied to the paddle frame 1224, such that the paddle frame can more easily manipulate an implantable device or implant into a position for implantation within the heart.

[0232] Referring to FIGS. 112-114, an example of a paddle frame 1324 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1385, a first connection member 1301 for attaching to a cap of the implantable device or implant, and a second connection member 1303 for attaching to an anchor of the device. The paddle frame 1324 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0233] The main support section 1385 includes an inner portion 1372 and an outer portion 1374. The inner portion 1372 is connected to the connecting member 1303 at the connection point 1378. The outer portion 1374 is connected to the inner portion 1372 at the connection point 1380 and extends to the connecting member 1301. The outer portion 1374 defines the full width TW of the paddle frame 1324. The inner portion 1372 is configured to move the paddle frame 1324 from its normal extended position (Figs. 112 - 114) when the anchor of the implantable device or implant is in the closed position to a constricted position when the anchor of the device is moved to the open position.

[0234] In the illustrated embodiment, the inner portion 1372 of the main support section 1385 includes an arm 1382 and a rounded member 1384. The arm 1382 extends inwardly from the connection point 1380, and the rounded member 1384 is connected to each of the arms 1382 and is connected to the connection point 1378. The configurations of the paddle frame 1324 shown in Figs. 112 - 114 are similar to each other except that the connection point 1380 between the inner portion 1372 and the outer portion 1374 of the paddle frame 1324 is disposed at a different position from the connecting member 1301 for each of these configurations. For example, the connection point 1380 for the configuration of the paddle frame 1324 shown in Fig. 112 is located farther from the connecting member 1301 compared to the configuration of the paddle frame shown in Fig. 113, and the connection point 1380 in the configuration of the paddle frame 1324 shown in Fig. 113 is located farther from the connecting member 1301 compared to the configuration of the paddle frame shown in Fig. 114. These different configurations result in the width Z between the connection points 1380 being different for each configuration. For example, the width Z in the configuration of the paddle 1324 shown in Fig. 112 is made larger compared to the width Z in the configuration of the paddle 1324 shown in Fig. 113, and the width Z in the configuration of the paddle 1324 shown in Fig. 113 is made larger compared to the width Z in the configuration of the paddle 1324 shown in Fig. 114.

[0235] When the anchor of the implantable device or implant is moved to the release position, the paddle frame 1324 receives a tension (e.g., the tension F shown in FIGS. 108 and 110) because the paddle frame 1324 is fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension F applied to the paddle frame 1324 moves the connection point 1378 and the connecting member 1301 outward, thereby moving the connection point 1380 inward. By moving the connection point 1380 inward, the outer portion 1374 is moved inward, whereby the overall width TW of the paddle frame 1324 is moved to the constricted position, thereby reducing the contact and / or friction between the natural structure of the heart, such as a cord, and the device, so that the implantable device or implant can be more easily maneuvered into a position for implantation within the heart.

[0236] When in the normal expanded position, the overall width TW of the paddle frame 1324 can be, for example, 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The constricted width of the paddle frame 1124 can be, for example, 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as about 8 mm. The ratio of the overall width TW to the constricted width can be, for example, 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2, 10 / 9 to 3 / 1.

[0237] In the illustrated embodiment, while showing the inner portion 1372 of the main support section 1385 having an arm 1382 that extends inwardly from the connection point 1380 and is connected to a round member 1384 that is connected to the connection point 1378, it will be understood that the inner portion 1372 can take any form that can move the paddle frame 1324 to the constricted position when a tension F is applied to the paddle frame 1324, so as to enable the paddle frame to more easily maneuver the implantable device or implant into a position for implantation within the heart.

[0238] Referring to FIGS. 115 - 116, an embodiment of a paddle frame 1424 for an implantable device or implant (e.g., device 200 shown in FIGS. 22 - 37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1485, a first connection member 1401 for attachment to a cap of the implantable device or implant, and a second connection member 1403 for attachment to an anchor of the device. The paddle frame 1424 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91 - 95), or the width can be greater than the thickness.

[0239] The main support section 1485 includes an inner portion 1472 and an outer portion 1474. The inner portion 1472 of the main support section 1485 includes an arm 1482 that extends inwardly from connection point 1480 and is connected to connection point 1478. The outer portion 1474 is connected to the inner portion 1472 at connection point 1480 and is connected to connection point 1478 via a biasing member 1484, and the outer portion 1474 extends to connection member 1401. The biasing member 1484 curves at least a portion of the outer portion 1474 such that the paddle has a curved lateral edge 1486 (FIG. 16). The curved lateral edge 1486 can be configured to abut against the outer shape of a spacer or bonding element (e.g., any bonding element described in this application) in the implantable device or implant. The biasing member 1484 can be, for example, a spring member, or any other member that can cause the paddle frame 1424 to have a curved lateral edge 1486.

[0240] The outer portion 1474 defines the full width TW of the paddle frame 1424. The inner portion 1472 and the biasing member 1484 are configured to move the paddle frame 1424 from its normal expanded position (Figs. 115 - 116) when the anchor of the implantable device or implant is in the closed position to a narrowed position when the anchor of the device is moved to the open position.

[0241] When the anchor of the implantable device or implant is moved to the open position, the paddle frame 1424 is subjected to a tension (e.g., the tension F shown in Figs. 108 and 110) because the paddle frame 1424 is fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension F applied to the paddle frame 1424 moves the connection point 1478 and the connecting member 1401 outwardly, thereby moving the connection point 1480 inwardly. By moving the connection point 1380 inwardly, the outer portion 1474 is moved inwardly, whereby the full width TW of the paddle frame 1424 is moved to the narrowed position. Additionally, by moving the connection point 1478 outwardly, the biasing member 1484 curves the curved side edge 1486 in the direction B (Fig. 116), whereby the full width TW of the paddle frame 1424 is moved to the narrowed position. By moving the paddle frame 1424 to the narrowed position, the implantable device or implant can be more easily maneuvered into a position for implantation within the heart, for example, by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device.

[0242] When in the normal extended position, the overall width TW of the paddle frame 1424 can be, for example, from 5 mm to 15 mm, such as from 7 mm to 12 mm, such as from 9 mm to 11 mm, such as about 10 mm. The narrowed width of the paddle frame 1124 can be, for example, from 3 mm to 12 mm, such as from 5 mm to 10 mm, such as from 7 mm to 9 mm, such as about 8 mm. The ratio of the overall width TW to the narrowed width can be, for example, from 5 / 4 to 2 / 1, such as from 4 / 3 to 3 / 2, from 10 / 9 to 3 / 1.

[0243] In some implementations, the biasing member 1484 can passively allow an implantable device or implant anchor to be more open when needed and, when the implantable device or implant is attached to the natural valve leaflet of the heart, can assist in the engagement in cooperation with the movement of the valve leaflet.

[0244] In the illustrated embodiment, although the inner portion 1472 of the main support section 1485 is shown having an arm 1482 that extends inwardly from the connection point 1480 and is connected to the connection point 1478, it will be understood that the inner portion 1472 can take any form that can move the paddle frame 1424 to the narrowed position when a tension F is applied to the paddle frame 1424, so as to enable the paddle frame to more easily maneuver the implantable device or implant to the position for implantation within the heart.

[0245] Referring to FIGS. 117-121, an embodiment of an implantable device or implant 1500 includes an anchor portion 1506 having one or more paddle frames 1524. The paddle frames 1524 are configured to enable easier manipulation of the device 1500 into a position for implantation within the heart by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device 1500. That is, the paddle frames 1524 are configured to move between an expanded position (when the device 1500 is in the closed position) and a constricted position (when the device 1500 is in the open position), and / or the paddle frames may include flexible outer portions that bend inwardly to reduce the width of the paddles when the flexible outer portions contact a natural structure of the heart, such as a cord.

[0246] When the paddle frames 1524 are in the constricted position, the friction between the natural structures of the heart and the device 1500 is reduced. The device 1500 may include any other mechanism related to an implantable device or implant as described in this application or in applications or patent documents incorporated herein by reference. The device 1500 may be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any device described herein may incorporate the mechanism of the device 1500.

[0247] The implantable device or implant 1500 includes a junction portion 1504, a proximal or attachment portion 1505, an anchor portion 1506, and a distal portion 1507. The junction portion 1504, the attachment portion 1505, and the distal portion 1507 can take any suitable form, such as the form of these portions in the device 200 shown in FIGS. 22-37, or any other form described in this application. In some implementations, the junction portion 1504 optionally includes a junction element 1510 (e.g., a spacer, a healing element, a gap filler, etc.) that can be used, for example, to be implanted between the leaflet tips 20, 22 of the native mitral valve MV. The junction element 1510 and the like can take any suitable form, such as any form described in this application. In the illustrated embodiment, the junction element is made from woven wire.

[0248] The attachment portion 1505 includes a first collar or proximal collar 1511 for engaging a capture mechanism 1513 (FIG. 119) of a delivery system (e.g., the delivery system 502 shown in FIGS. 86A, 87A, 88, and 89). The proximal collar 1511 can take any suitable form, such as any form described in this application. The capture mechanism 1513 can take any suitable form, such as any form described in this application.

[0249] The distal portion 1507 includes a cap 1514 attached to the anchor 1508 of the anchor portion 1506 such that moving the cap 1514 causes the anchor 1508 to move between an open position and a closed position. The cap 1514 can take any suitable form, such as any of the forms described in this application. In the illustrated embodiment, an actuating element 1512 (e.g., an actuating wire, an actuating shaft, etc.) extends from a delivery system (e.g., any of the delivery systems described in this application) and engages the cap 1514 to move the cap 1514 relative to a joining element or spacer 1510, thereby enabling operation of the device 1500. The actuating element 1512 can engage and move the cap by any suitable means, such as any of the means provided in this application.

[0250] The anchor portion 1506 of the device 1500 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in FIGS. 22-37 (except that the paddle frame 224 is replaced by the paddle frame 1524 as shown in FIGS. 91-95 and described in more detail below), or any other form described in this application that can include the paddle frame 1524. The anchor portion 1506 can include a plurality of anchors 1508, and each anchor 1508 includes an outer paddle 1520, an inner paddle 1522, a paddle extension member or paddle frame 1524, and a clasp 1530.

[0251] The paddle frame 1524 includes a main support section 1585, a first connection member for attachment to a cap of an embedded device or implant (e.g., connection member 601 shown in FIGS. 91-95, or any other connection member described in this application), and a second connection member for attachment to an anchor of the device (connection member 603 shown in FIGS. 91-95, or any other connection member described in this application). The paddle frame 1524 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0252] The main support section 1585 includes a rigid inner portion 1572 and a flexible outer portion 1574. The rigid inner portion 1572 has a first end 1581 connected to the cap 1514 and a second end 1583 connected to the anchor 1508. Referring to FIGS. 120 and 121, the rigid inner portion is configured to support the paddles 1520, 1522 of the anchor and to provide sufficient force to facilitate the engagement of the natural valve tips 20, 22 with the engagement element 1510 when the anchor 1508 is in the closed position. The rigid inner portion 1572 can be formed, for example, from metal, plastic, or the like.

[0253] Referring again to FIGS. 117 - 121, the flexible outer portion 1574 is connected to the rigid inner portion and defines the full width of the paddle frame 1524. That is, the flexible outer portion 1574 has a greater full width than the rigid inner portion 1572. The flexible outer portion 1574 is configured to be bent by a force (e.g., a force from the flexible outer portion 1574 that contacts the suture during implantation of the device 1500) and to more easily maneuver the device 1500 into a position for implantation in the heart. Referring to FIGS. 120 and 121, when the anchor 1508 is in the closed position and the valve tip is joined to the joining element 1510, the flexible outer portion 1574 provides a larger surface area (compared to the rigid inner portion 1572) that contacts the valve tip to hold the valve tip against the joining element 1510 by maintaining its normal full width. The flexible outer portion 1574 can be formed, for example, from metal and plastic.

[0254] The full width of the flexible outer portion 1574 can be, for example, 5 mm - 15 mm, such as 7 mm - 12 mm, such as 9 mm - 11 mm, such as about 10 mm. The width of the inner portion 1572 can be, for example, 2 mm - 8 mm, such as 4 mm - 6 mm, such as about 5 mm.

[0255] In some implementations, the flexible outer portion 1574 is shaped inwardly such that when the anchor 1508 is in the open position, the full width of the outer portion 1574 is reduced, and when the anchor 1508 is moved to the closed position, the outer portion moves back to its normal full width.

[0256] While the illustrated embodiment shows a rigid inner portion 1572 and a flexible inner portion 1574 having a round shape, it will be appreciated that the inner portion 1572 and the outer portion 1574 can take any form that allows the device 1500 to be more easily maneuverable into a position for implantation within the heart while providing sufficient support to facilitate joining the leaflets of the native heart valve to the joining element 1510.

[0257] Referring to FIGS. 122 - 124, an exemplary implementation of an implantable device or implant 1600 includes a junction portion 1604, a proximal or attachment portion 1605, an anchor portion 1606, and a distal portion 1607. The implantable device or implant 1600 is configured to more easily maneuver the device 1600 into a position for implantation within the heart by moving the paddle frame 1624 of the anchor portion 1606 to a constricted position (FIG. 124), thereby reducing contact and / or friction between a natural structure of the heart, such as a cord, and the device 1600. That is, the paddle frame 1624 is configured to move between an expanded position (FIG. 122) when the device 1600 is in the closed position and a constricted position (FIG. 123) when the device 1600 is in the open position, and when the paddle frame 1624 is in the constricted position, contact between the natural structure of the heart and the device 1600 is reduced. The device 1600 can include any other features related to implantable devices or implants as described in this application or as described in applications or patent documents incorporated herein by reference, and the device 1600 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any device described herein can incorporate the features of the device 1600.

[0258] The attachment portion 1605 includes a first or proximal collar 1611 for engaging with a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 44-49) of a delivery system (e.g., delivery system 202 shown in FIGS. 38-49). The proximal collar 1611 can take any suitable form, such as any form described in this application for example. The distal portion 1607 includes a cap 1614 attached to an outer paddle 1620 of an anchor 1608 so that by moving the cap 1614, the anchor 1608 can be moved between an open position and a closed position. The cap 1614 can take any suitable form, such as any form described in this application for example.

[0259] The anchor portion 1606 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in FIGS. 22-37 for example, or any other form described in this application that can include a paddle frame 1524. The anchor portion 1606 can include a plurality of anchors 1608, and each anchor 1608 includes an outer paddle 1620, an inner paddle 1622, a paddle extension member or paddle frame 1624, and a clasp 1630. In the illustrated embodiment, the inner paddle 1622 is formed from a material having a greater hardness compared to the material of the outer paddle 1620.

[0260] Referring to FIG. 124, the paddle frame 1624 includes a main support section 1685, a first connecting member 1601 for attachment to the cap 1614 of the device 1600, and a second connecting member 1603 for attachment to a connecting portion 1623 between the inner paddle 1622 and the outer paddle 1620 of the anchor 1608. The paddle frame 1624 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91 - 95), or the width can be greater than the thickness. However, the paddle frame 1624 can take any suitable form, such as any of the forms described in this application.

[0261] In some implementations, the joining portion 1604 includes a joining element 1610 (e.g., a joining element 1610 that can be used to embed between the valve tips 20, 22 in the original mitral valve MV). The joining element 1610 and the like can take any suitable form, such as any of the forms described in this application. The joining element 1610 is connected to the connecting portion 1623 of the inner paddle 1622 in the anchor 1608. In the illustrated embodiment, the joining element 1610 includes one or more flexible portions 1687 that are connected to the inner paddle 1622. The flexible portion 1687 can be formed from a woven fabric material having a loose weave compared to the inner paddle portion and / or the remainder of the joining element 1610, or can be formed from a more elastic elastic material compared to the inner paddle portion and / or the remainder of the joining element 1610, or can be formed in any other manner that makes the flexible portion 1687 more flexible and / or more stretchable compared to the inner paddle portion and / or the remainder of the joining element 1610.

[0262] When implanting, by opening and closing paddles 1620, 1622 of anchor 1608, the natural valve leaflet tip can be gripped between paddles 1620, 1622 and engagement element 1610. Anchor 1608 is moved between a closed position (Figure 122) and various open positions (e.g., the position shown in Figure 123) by extending and retracting actuation element 1612 (e.g., an actuation wire, an actuation shaft, etc.). By extending and retracting actuation element 1612, the spacing between engagement element 1610 and cap 1614 increases and decreases, respectively. Proximal collar 1611 and engagement element 1610 slide along actuation element 1612 during movement, whereby the spacing between engagement element 1610 and cap 1614 changes, causing paddles 1620, 1622 to move between different positions, thereby gripping the natural valve leaflet tip during implantation.

[0263] In the illustrated embodiment, the actuating element 1612 includes a wide portion 1689 for easily moving the paddle frame 1624 to the constricted position. Referring to FIG. 123, when the anchor 1608 is moved from the closed position to the open position by moving the actuating element 612 downward through the joining element 610 in the direction Y, the wide portion 1689 of the actuating element 1612 engages the flexible portion 1687 of the joining element 1610, causing the flexible portion 1687 to move in the outward direction Z. This movement of the flexible portion 1687 in the outward direction Z causes the connecting portion 1625 of the inner paddle 1622 to move in the outward direction D relative to the cap 1614, and thereby the connecting portion 1623 of the anchor 1608 (to which the paddle frame 1624 is connected) is also moved in the direction D. The rigid stiffness of the inner paddle 1622 aids in facilitating the movement of the connecting portion 1623. Due to the paddle frame 1624 being connected to the cap 1614 and to the connecting portion 1623 of the anchor 1608, this movement of the connecting portion 1623 in the direction D applies a tension force F (FIG. 124) to the paddle frame 1624, causing the paddle frame 1624 to move to the constricted position (FIG. 124). In the illustrated embodiment, the wide portion 1689 of the actuating element 1612 has a tapered shape to easily move the paddle frame 1624 to the constricted position by engaging the flexible portion 1687 of the joining element 1610. In some implementations, the wide portion 1689 can have a spherical shape or any other suitable shape.

[0264] In some implementations, the wide portion 1689 is configured to widen the transition portion 1625 for a small portion of the movement of the actuating element. For example, the movement path of the actuating element can include a movement path from a start corresponding to a full occlusion of the device to an end corresponding to a full occlusion of the device. The wide portion 1689 can be configured to keep the transition portion 1625 at its original width along the start portion of the movement path, to move the transition portion 1625 to a wider width between the middle portions of the movement path, and further to return the transition portion 1625 to its original width along the end portion of the movement path.

[0265] Referring to FIG. 124, when in the narrowed position, the paddle frame 1624 has a length L2 and an overall width W2. The width of the paddle frame 1424 when in the normal extended position can be, for example, 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as approximately 10 mm. The narrowed width W2 of the paddle frame 1124 can be, for example, 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as approximately 8 mm. The ratio of the normal width to the narrowed width W2 can be, for example, 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2, 10 / 9 to 3 / 1.

[0266] Referring to FIGS. 125 and 126, an embodiment of the paddle frame 1724 for an implantable device or implant (e.g., device 200 shown in FIGS. 22 - 37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1785, a first connecting member 1701 for attachment to the cap of the implantable device or implant, and a second connecting member (e.g., connecting member 603 shown in FIGS. 91 - 95, or any other connecting member described in this application) for attachment to the anchor of the device. The paddle frame 1724 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91 - 95), or the width can be greater than the thickness.

[0267] The main support section 1785 includes an inner portion 1772 and an outer portion 1774. The inner portion 1772 is connected to the outer portion 1774 at the connection points 1780, and the outer portion 1774 extends to the connecting member 1701. In the illustrated embodiment, the inner portion 1772 includes arms 1782 that extend inwardly from each connection point 1780 and converge with each other at the connection portion 1778 such that the arm 1782 has a V-shape when the paddle frame 1724 is in the extended position (FIG. 126). The connection portion 1780 between the inner portion 1772 and the outer portion 1774 can include an opening 1773 for receiving a holding device (e.g., suture, pin, or other suitable device) for connecting the openings 1773 to each other to maintain the paddle frame 1724 in the narrowed position (FIG. 125). When the holding device is removed from the opening 1773 such that the openings 1773 are no longer connected, the paddle frame 1724 is configured to move outwardly in the direction Z towards its normal extended position. That is, the paddle frame 1724 can be formed from pre-formed material to the extended position (the position as shown in FIG. 126). By using the holding device, the openings 1773 can be connected at the connection points 1780, whereby the paddle frame 1724 is maintained in the folded and narrowed position (the position as shown in FIG. 125). Thereafter, by removing the holding device, the paddle frame 1724 will return to its normal extended position by the spring force.

[0268] When moving an implantable device or implant to a position embedded on the native valve leaflet of a patient (e.g., mitral valve leaflets 20, 22, tricuspid valve leaflets 30, 32, 34, or other leaflets), the paddle frame 1724 is maintained in a constricted position, thereby enabling easier maneuvering of the implantable device or implant to a position for implantation within the heart by reducing contact and / or friction between natural structures of the heart, such as cords, and the device. After the device is positioned for implantation, the holding device is removed from the opening 1773, whereby the paddle frame 1724 is moved to an expanded position to have a larger surface area for the anchors of the device to capture the leaflets of the native valve.

[0269] The outer portion 1774 defines the overall width of the paddle frame 1724 (e.g., the expanded width EW shown in FIG. 126 and the constricted width NW shown in FIG. 125). The expanded width EW of the paddle frame 1424 when in its normal expanded position can be, for example, 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The constricted width NW of the paddle frame 1124 can be, for example, 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as about 8 mm. The ratio of the normal width to the constricted width W2 can be, for example, 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2, 10 / 9 to 3 / 1.

[0270] In the illustrated embodiment, although the inner portion 1772 of the main support section 1785 is shown as having the strut arms 1782 forming a V - shape, it is understood that the inner portion 1772 can take any form that enables folding the paddle frame 1724 to a constricted position and maintaining it in that constricted position when engaged by the holding device, and further enables moving the paddle frame 1724 to an expanded position when releasing the holding device from the paddle frame 1724.

[0271] Referring to FIGS. 127 - 130, an exemplary implementation of an implantable device or implant 1800 includes an anchor portion 1806 having one or more paddle frames 1824 movable to a constricted position to more easily maneuver the device 1800 into position for implantation within the heart by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device 1800. That is, when the device 1800 is positioned to be implanted onto the natural leaflets of a native valve, an actuation line 1890, when controlled by a user, generates a compressive force C (FIG. 128) on the paddle frame 1824, moving the paddle frame 1824 to the constricted position, thereby reducing contact and / or friction between the natural structures of the heart and the device 1800. The device 1800 can include any other features related to implantable devices or implants as described in this application or as described in applications or patent documents incorporated herein by reference. The device 1800 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any of the devices described herein can incorporate the mechanisms of the device 1800.

[0272] The implantable device or implant 1800 includes a junction portion 1804, a proximal or attachment portion 1805, an anchor portion 1806, and a distal portion 1807. The junction portion 1804, the attachment portion 1805, and the distal portion 1807 can take any suitable form, such as the form of these portions in the device 200 shown in FIGS. 22 - 37, or any other form described in this application. In some implementations, the junction portion 1804 includes a junction element 1810 (e.g., a spacer, a healing element, a gap filler, etc.) that can be used, for example, to be implanted between the leaflets 20, 22 of the native mitral valve MV. The junction element 1810 can take any suitable form, such as any form described in this application.

[0273] The attachment portion 1805 includes a first or proximal collar 1811 for engaging with a capture mechanism (e.g., the capture mechanism 213 shown in FIGS. 44-49) of a delivery system (e.g., the delivery system 202 shown in FIGS. 38-49). The proximal collar 1811 can take any suitable form, such as any form described in this application.

[0274] The distal portion 1807 includes a cap 1814 attached to an anchor 1808 of the anchor portion 1806 such that movement of the cap 1814 causes the anchor 1508 to move between an open position and a closed position. The cap 1814 can take any suitable form, such as any form described in this application. In the illustrated embodiment, an actuating element 1812 (e.g., an actuating wire, an actuating shaft, etc.) extends from a delivery system (e.g., any delivery system described in this application) and engages the cap 1814 to move the cap 1814 relative to a joining element or spacer 1810, enabling operation of the device 1800. The actuating element 1812 can engage and move the cap by any suitable means, such as any means provided in this application.

[0275] The anchor portion 1806 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in FIGS. 22 to 37, or any other form described in the present application. The anchor portion 1806 can include a plurality of anchors 1808, and each anchor 1808 includes an outer paddle 1820, an inner paddle 1822, a paddle extension member or paddle frame 1824, and a clasp 1830. The paddle frame 1824 can include a main support section 1885, a first connecting member for attaching to the cap 1814, and a second connecting member for attaching to the connecting portion 1823 of the anchor 1808. The paddle frame 1824 can be attached to the connecting portion of the anchor and the cap by any suitable means, such as any of the means described in the present application. The thickness and width of the paddle frame 1824 can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be larger than the width (as shown in FIGS. 91 to 95), or the width can be larger than the thickness.

[0276] The paddle frame 1824 includes an end 1801 configured to be attached to the cap 1814 and a free end 1803. The paddle frame 1824 includes a first opening 1891 and a second opening 1892 for receiving one or more operating lines 1890 of the delivery system. Referring to FIGS. 127-129, in some examples, a single operating line 1890 extends into the delivery system through the first opening 1891 and the second opening 1892 of each paddle frame 1824, whereby a user can move the paddle frame 1824 to the constricted position by pulling on the operating line 1890. Referring to FIG. 129, the operating line 1890 can also extend through the opening 1893 of the clasp 1830 of each paddle before extending into the delivery system. Referring to FIG. 128, when the user pulls on the operating line 1890, a force is generated in the direction Y at each end of the operating line 1890 based on the operating line extending through the openings 1891, 1892, whereby a compressive force C is applied to the paddle frame 1824. The compressive force C causes the paddle frame 1824 to be moved to the constricted position.

[0277] Referring to FIG. 129, the operating line 1890 can also extend through the opening 1893 of the clasp 1830 of each paddle before extending into the delivery system. When the user pulls on the operating line 1890, the clasp 1830 is released and the paddle frame 1824 is moved to the constricted position.

[0278] Referring to FIG. 130, in some examples, the connection operation line 1889 extends as a closed loop between the first opening 1891 and the second opening 1892 of each paddle frame 1824, and a single operation line 1890 extends through the closed loop formed by each connection line 1889, so that the user can move both paddle frames 1824 to the narrowed position by simply pulling the single operation line 1890. That is, by pulling the single operation line 1890, a compressive force (for example, a compressive force similar to the compressive force C shown in FIG. 128) is generated on each of the paddle frames 1824, and at the same time, the paddle frame 1824 is moved to the narrowed position. In the illustrated embodiment, the single operation line 1890 extends through the joining element 1810 before extending into the delivery system. Referring to FIGS. 127 to 130, the operation lines 1889, 1890 can be, for example, sutures.

[0279] Referring to FIG. 128, when in the narrowed position, the paddle frame 1824 has a length L2 and an overall width W2. The width of the paddle frame 1424 in the normal extended position can be, for example, 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The narrowed width W2 of the paddle frame 1124 can be, for example, 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as about 8 mm. The ratio of the normal width to the narrowed width W2 can be, for example, 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2, 10 / 9 to 3 / 1. Although the dimensions described above for the paddle frame 1824 in the narrowed and extended positions are made with reference to the examples shown in FIGS. 127 to 129, it will be understood that the same dimensions can be applied to the example shown in FIG. 130.

[0280] Referring to FIGS. 131 - 136, an exemplary implementation of an implantable device or implant 1900 includes an anchor portion 1906 having one or more paddle frames 1924 that are movable to a constricted position to more easily maneuver the device 1900 into position for implantation within the heart, for example, by reducing contact and / or friction between the natural structures of the heart, such as chordae tendineae, and the device 1900. That is, when the device 1900 is positioned for implantation on the leaflets of a native valve, an actuation line 1990, when controlled by a user, generates a compressive force (e.g., a compressive force similar to compressive force C of FIG. 128) on the paddle frame 1924, moving the paddle frame 1924 to the constricted position, thereby reducing contact and / or friction between the natural structures of the heart and the device 1900. The device 1900 can include any other features related to implantable devices or implants, as described in this application or as described in applications or patent documents incorporated herein by reference. The device 1900 can be positioned to engage valve tissue (e.g., leaflets 20, 22, etc.) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any device described herein can comprise the features of the device 1900.

[0281] The device or implant 1900 includes a junction portion 1904, a proximal or attachment portion 1905, an anchor portion 1906, and a distal portion 1907. The junction portion 1904, the attachment portion 1905, and the distal portion 1907 can take any suitable form, such as the form of these portions in device 200 shown in FIGS. 22 - 37, or any other form described in this application. In some implementations, the junction portion 1904 includes a junction element 1910 (e.g., a spacer, a healing element, a gap filler, etc.) that can be used, for example, for implantation between leaflets 20, 22 of a native mitral valve MV. The junction element 1910, etc., can take any suitable form, such as any form described in this application.

[0282] The attachment portion 1905 includes a first or proximal collar 1911 for engaging with a capture mechanism (e.g., the capture mechanism 213 shown in FIGS. 44-49) of a delivery system (e.g., the delivery system 202 shown in FIGS. 38-49). The proximal collar 1911 can take any suitable form, such as any form described in this application.

[0283] The distal portion 1907 includes a cap 1914 attached to the anchor 1908 of the anchor portion 1906 such that moving the cap 1914 can move the anchor 1908 between an open position and a closed position. The cap 1914 can take any suitable form, such as any form described in this application. In the illustrated embodiment, an actuating element 1912 (e.g., an actuating wire, an actuating shaft, etc.) extends from a delivery system (e.g., any delivery system described in this application) and engages with the cap 1914 to move the cap 1914 relative to a joining element or spacer 1910, thereby enabling movement of the device 1900. The actuating element 1912 can engage with the cap and move the cap by any suitable means, such as any means provided in this application.

[0284] The anchor portion 1906 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in FIGS. 22 to 37, or any other form described in the present application. The anchor portion 1906 can include a plurality of anchors 1908, and each anchor 1908 includes an outer paddle 1920, an inner paddle 1922, a paddle extension member or paddle frame 1924, and a clasp 1930. The paddle frame 1924 can include a main support section 1985, a first connection member 1901 for attachment to the cap 1914, and a second connection member 1903 for attachment to the connection portion 1923 of the anchor 1908. The paddle frame 1924 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described in the present application. The thickness and width of the paddle frame 1924 can take any suitable form. For example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91 to 95), or the width can be greater than the thickness.

[0285] The main support section 1985 includes an inner portion 1972 and an outer portion 1974 that are connected to the connecting member 1901. In the illustrated embodiment, the inner portion 1972 has a pair of arms 1982 that extend from the connecting member 1901 to the connecting member 1903, and the arms 1982 provide support for the anchor 1908. The outer portion 1974 has a pair of arms 1980 that extend outwardly from the connecting member 1901 beyond the arms 1982 of the inner portion 1972, whereby the arms 1980 define the full width of the paddle frame 1924 (e.g., the full width W2 shown in FIG. 128). Referring to FIG. 131, each of the arms 1980 includes an opening 1992 for receiving one or more operating lines 1990 (FIGS. 132-136) of the delivery system. The arms 1982 can also include an opening 1991 for receiving one or more operating lines 1990. The opening 1991 can be an opening for connecting to the connection portion 1923 of the anchor 1908 at the connecting member 1903 (as shown in the illustrated example), or the opening 1991 can be a separate opening from the connecting member 1903.

[0286] Referring to FIGS. 132 and 133, in some examples, a single actuation line 1990 corresponds to each paddle frame 1924 to move the paddle frame 1924 to a constricted position. In the illustrated embodiment, the actuation line 1990 extends through openings 1991, 1992 of the paddle frame 1924, whereby a user can move the paddle frame 1924 to the constricted position by applying a tensile force to the actuation line 1990. Each actuation line 1990 has a first end 1993 and a second end 1994. The first end 1993 extends from the delivery system through an opening 1991 of one arm 1982 in the inner portion 1972, through an opening 1992 of one arm 1980 in the outer portion 1974, through an opening 1992 of the other arm 1980 in the outer portion 1974, and through an opening 1991 of the other arm 1982 in the inner portion 1972, and the second end 1994 of the actuation line 1990 extends into the delivery system. In the example shown in FIG. 132, the tensile forces on both ends 1993, 1994 of the actuation line 1990 generate a compressive force on the arm 1980 of the outer portion 1974 (FIG. 131) to move the arm 1980 toward the inner portion 1972 of the paddle frame 1924, thereby moving the paddle frame to the constricted position.

[0287] Referring to FIG. 133, the actuation line 1990 can also extend through an opening 1931 of the clasp 1930 of each paddle before extending into the delivery system. In the example shown in FIG. 132, the tensile forces on both ends 1993, 1994 of the actuation line 1990 move the paddle frame to the constricted position and release the clasp.

[0288] Referring to FIG. 134, a single actuating line 1990 corresponds to each paddle frame 1924 to move the paddle frame 1924 to the narrowed position. Each actuating line 1990 extends from a delivery system, through a joining element 1910, through an opening 1992 of one arm 1980 in the outer portion 1974, through an opening 1991 of one arm 1982 in the inner portion 1972, through an opening 1991 of the other arm 1982 in the inner portion 1972, through an opening 1992 of the other arm 1980 in the outer portion 1974, and has a first end (not shown) and a second end (not shown) of the actuating line 1990 that extends into the delivery system through the joining element 1910. The tensile forces on both ends of the actuating line 1990 generate a compressive force on the arm 1980 of the outer portion 1974 (FIG. 131) to move the arm 1980 toward the inner portion 1972 of the paddle frame 1924, thereby moving the paddle frame 1924 to the narrowed position.

[0289] Referring to FIGS. 135 and 136, in some implementations, a connecting actuating line 1989 is connected to each paddle frame 1924, and the actuating line 1990 is connected to the connecting actuating line 1989, whereby the user can move the paddle frame 1924 to the narrowed position by pulling the actuating line 1990. Referring to FIG. 135, in some implementations, the connecting actuating line 1989 extends as a closed loop between the opening 1991 in the inner portion 1972 of the paddle frame 1924 and the opening 1992 in the outer portion 1974. Referring to FIG. 136, in some implementations, the connecting actuating line 1989 extends as a closed loop between the openings 1992 in the outer portion 1974 of the paddle frame 1924, but the connecting actuating line 1989 does not extend through the opening 1991 in the inner portion 1972.

[0290] In both examples shown in FIGS. 135 and 136, the tensile force on the operating line 1990 generates a compressive force on the arm 1980 of the outer portion 1974 (FIG. 131), moving the arm 1980 toward the inner portion 1972 of the paddle frame 1924, thereby moving the paddle frame to the narrowed position. In the examples shown in FIGS. 135 and 136, while separate operating lines 1990 attached to the movement connection lines 1989 of each paddle frame 1924 are shown, in some implementations, a single operating line (e.g., an operating line similar to the line 1890 shown in FIG. 130) can be attached to the connection operating lines 1989 of each paddle frame 1924 to move both paddle frames 1924 to the narrowed position by pulling on the end of the single operating line. Referring to FIGS. 131 - 136, the operating lines 1989, 1990 can be, for example, sutures.

[0291] Still referring to FIGS. 131 - 136, the overall width of the paddle frame 1924 (defined by the outer portion 1974 of the paddle frame 1924) when in the normal expanded position can be, for example, 5 mm - 15 mm, such as 7 mm - 12 mm, such as 9 mm - 11 mm, such as about 10 mm. The narrowed width of the paddle frame 1124 can be, for example, 3 mm - 12 mm, such as 5 mm - 10 mm, such as 7 mm - 9 mm, such as about 8 mm. The ratio of the normal width to the narrowed width can be, for example, 5 / 4 - 2 / 1, such as 4 / 3 - 3 / 2, 10 / 9 - 3 / 1.

[0292] Referring to FIGS. 137-148, an exemplary implementation of an implantable device or implant 2000 (FIGS. 139-144) includes an anchor portion 2006 having one or more paddle frames 2024. The paddle frames 2024 are configured to enable the device 2000 to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device 2000. For example, the actuation line is controlled by the user to cause a compressive force (e.g., compressive force C shown in FIG. 128) on the paddle frame 2024 to move the paddle frame 2024 from its normal expanded position (FIGS. 140 and 142) to its constricted position (FIGS. 139 and 141) when the device 2000 is positioned for implantation on the leaflet of a native valve such that the friction between the natural structure of the heart and the device 2000 is reduced. The device 2000 can include any other features related to implantable devices or implants as described in this application or as described in applications or patent documents incorporated herein by reference, and the device 2000 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any device described herein can incorporate the features of the device 2000.

[0293] Referring to FIGS. 143 - 144, the implantable device or implant 2000 includes a junction portion 2004, a proximal or attachment portion 2005, an anchor portion 2006, and a distal portion 2007. The junction portion 2004, the attachment portion 2005, and the distal portion 2007 can take any suitable form, such as the form of these portions in the device 200 shown in FIGS. 22 - 37, or any other form described in this application. In some embodiments, the junction portion 2004 optionally includes a junction element 2010 (such as a spacer, a healing element, a gap filler, etc.) that can be used, for example, to be embedded between the cusp tips 20, 22 of the native mitral valve MV. The junction element 2010 can take any suitable form, such as any form described in this application.

[0294] The attachment portion 2005 includes a first collar or proximal collar 2011 for engaging a capture mechanism (such as the capture mechanism 213 shown in FIGS. 44 - 49) of a delivery system (such as the delivery system 202 shown in FIGS. 38 - 49). The proximal collar 2011 can take any suitable form, such as any form described in this application.

[0295] The distal portion 2007 includes a cap 2014 attached to the anchor 2008 of the anchor portion 2006 such that when the cap 2014 moves, the anchor 2008 moves between an open position and a closed position. The cap 2014 can take any suitable form, such as any form described in this application. An actuating element (such as an actuating element identical or similar to the actuating element 212 shown in FIGS. 22 - 37) extends from a delivery system (such as any delivery system described in this application), through the junction element 2010 via an opening 2009 (FIG. 143), and engages the cap 2014 to move the cap 2014 relative to the junction element 2010, thereby enabling movement of the device 2000. The actuating element can engage and move the cap by any suitable means, such as any means provided in this application.

[0296] The anchor portion 2006 can take any suitable form, such as the form of the anchor portion 206 in the device 200 shown in FIGS. 22 to 37, or any other form described in the present application. The anchor portion 2006 can include a plurality of anchors 2008, and each anchor 2008 includes an outer paddle 2020, an inner paddle 2022, a paddle extension member or paddle frame 2024, and a clasp (such as the clasp 230 shown in FIGS. 22 to 37). Referring to FIGS. 137 and 138, the paddle frame 2024 can include a main support section 2085 and a connecting member 2003 for attachment to the cap 2014. The paddle frame 2024 can be attached to the cap 2014 by any suitable means, such as any means described in the present application. Referring to FIGS. 145 to 148, in the illustrated embodiment, both anchors 2008 are defined by a paddle ribbon 2001 that includes the inner paddle 2022 and the outer paddle 2020 of each anchor 2008. The inner paddle 2022 of each anchor 2008 is attached by a connection portion 2025 configured to connect the inner paddle 2022 to the joining element 2010 (as shown in FIG. 148). In the illustrated embodiment, the connection portion 2025 includes an opening 2094 for receiving the distal portion of the joining element 2010. The outer paddle 2020 of each anchor 2008 is attached by a connection portion 2021 configured to connect the outer paddle 2020 to the cap 214 (as shown in FIG. 148). In the illustrated embodiment, the connection portion 2021 includes an opening 2096 for receiving a portion of the cap 2014. Each inner paddle 2022 is attached to the corresponding outer paddle 2020 by a connection portion 2023.

[0297] Referring to FIGS. 137 and 138, the paddle frame 2024 includes two or more arms 2080 that define the full width TW of the anchor 2008, where at least some of the arms 2080 are connected at the distal portion of the paddle frame 2024 (e.g., the portion of the paddle frame 2024 proximate to the connecting member 2003). Each of the arms 2080 includes one or more openings 2091, 2092 for receiving one or more actuation lines (e.g., the actuation lines 1890 shown in FIGS. 127-130), such that by the user pulling on the actuation lines, the paddle frame 2024 can be moved to the constricted position. The illustrated embodiment includes two arms 2080, each including a proximal opening 2091 and a distal opening 2092. In some implementations, a single actuation line can extend through each opening 2091, 2092 such that the paddle frame 2024 can be moved to the constricted position by a single actuation line. However, it will be understood that any suitable number of actuation lines can extend through the openings 2091, 2092 when moving the paddle frame 2024 to the constricted position.

[0298] Referring to FIG. 137, the arms 2080 are connected to each other at the distal portion of the paddle frame 2024 via the connection link 2083. When a user applies a tension F to the paddle frame 2024 by pulling one or more operating lines extending through the openings 2091, 2092, the connection between the two arms 2080 causes the arms 2080 to pivot, bend, and / or articulate inwardly in the Z direction about the connection link 2083. This pivoting, bending, and / or articulating of the arms 2080 causes the main support section 2085 of the arms 2080 to move inwardly in the X direction, thereby placing the paddle frame 2024 in the narrowed position. In the illustrated embodiment, the connection link 2083 includes a first member 2087 attached to one arm 2080, a second member 2089 attached to the other arm 2080, and a thin arch-shaped member 2086 connecting the first member 2087 to the second member 2089. However, the connection link 2083 can take any suitable form that can pivot, bend, and / or articulate the arms in the inward Z direction when the tension F is applied to the paddle frame 2024. In some implementations, the connection link 2083 is integral with the arms 2080 of the paddle frame 2024.

[0299] Still referring to FIG. 137, the overall width TW of the paddle frame 1924 in the normal extended position can be, for example, 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The narrowed width of the paddle frame 1124 can be, for example, 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as about 8 mm. The ratio of the normal width to the narrowed width W2 can be, for example, 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2, 10 / 9 to 3 / 1.

[0300] Figures 149 - 156 illustrate examples of paddle frames 2024 that can be used with the implantable device or implant 2000 shown in FIGS. 139 - 144. Referring to FIG. 149, device 2000 can include a paddle frame 2124 having an inner portion 2172 and an outer portion 2174. The outer portion 2174 has two arms 2180 each including an opening 2192 for receiving one or more actuation lines (e.g., actuation line 1890 shown in FIGS. 27 - 30) such that a user can move the paddle frame to a constricted position by pulling on the actuation line. The arms 2180 define the overall width TW of the anchors in device 2000.

[0301] The arms 2180 are connected to each other at the distal portion of the paddle frame 2124 via a connection link 2183. This connection between the two arms 2180 causes the arms 2180 to pivot, flex, and / or articulate inwardly in the Z direction about the connection link 2183 when a user applies a tension force F to the paddle frame 2024 by pulling on one or more actuation lines extending through the openings 2192. This pivoting, flexing, and / or articulating of the arms 2180 causes the main support sections 2185 of the arms 2180 to move in the inward X direction, thereby positioning the paddle frame 2124 in a constricted position. In the illustrated embodiment, the connection link 2183 has a first member 2187 attached to one arm 2180, a second member 2189 attached to the other arm 2180, and a thin arched member 2186 connecting the first member 2187 to the second member 2189. The connection link 2183 can take any suitable form, such as any of the forms described with respect to the connection link 2083 shown in FIG. 137.

[0302] The inner portion 2172 of the paddle frame 2124 has two arms 2182 that extend inwardly and downwardly from the proximal portion of the arm 2180 and assist in easily moving the paddle frame 2124 to the narrowed position. The arms 2182 are connected to the arm 2180 at the connection point 2197. In some implementations, the connection point 2197 includes a thin arched portion that assists in easily moving the arms 2180, 2182 in the inward direction X. The arms 2182 are connected to each other at the connection point 2198. The connection point 2198 can include a thin rounded portion that further assists in easily moving the arms 2180, 2182 in the inward direction X.

[0303] Referring to FIG. 150, in some implementations, the device 2000 can include a paddle frame 2224 having an inner portion 2272 and an outer portion 2274. The outer portion 2274 has two arms 2280 each including an opening 2292 for receiving one or more actuation lines (e.g., the actuation line 1890 shown in FIGS. 27 - 30) such that a user can move the paddle frame to the narrowed position by pulling the actuation line. The arms 2280 define the total width TW of the anchor in the device 2000.

[0304] The arms 2280 are connected to each other at the distal portion of the paddle frame 2224 via the connection link 2283. When a user applies a tension F to the paddle frame 2224 by pulling one or more operating lines extending through the opening 2292, this connection between the two arms 2280 causes the arms 2280 to pivot, bend, and / or articulate inwar...

Claims

1. It is an implantable device, An anchor portion comprising one or more anchors configured to be attached to one or more leaflets of a natural heart valve, Each of the one or more anchors comprises a plurality of paddles and paddle frames, The paddle frame has an inner frame portion and at least two outer arms, each of which is connected to the inner frame portion at a distal connection point and extends proximal to the proximal portion of the implantable device, with an anchor portion. The paddle frame comprises one or more actuation lines connected to the paddle frame, thereby allowing the user to move the paddle frame from an extended position having an extended width to a constricted position having a constricted width by applying tension to the one or more actuation lines, wherein the extended width is greater than the constricted width. The one or more operating lines extend from the proximal portion to the distal portion, along each of the outer arms from the distal portion to the proximal portion, and radially inward from the proximal portion, and are connected to a fixed position on the implantable device relative to the outer arm. An implantable device in which one or more of the aforementioned anchors are configured to move between an open position and a closed position.

2. The embedded device according to claim 1, wherein the fixing position is located on the inner frame member.

3. The implantable device according to claim 2, wherein the fixed position includes an opening on the inner frame member in the proximal portion of the implantable device, and the opening connects the inner frame member to one of the plurality of paddles.

4. The embedded device according to claim 1, wherein the fixing position is on a paddle clip.

5. The implantable device according to claim 1, wherein providing the tension to one or more operating lines causes each of the outer arms to pivot or bend inward around the distal connection point.

6. The implantable device according to claim 1, wherein each outer arm has a first portion extending distally from the distal connection point, a second portion extending proximal toward the proximal portion, and a winding portion connecting the first portion to the second portion.

7. The embedded device according to claim 6, wherein providing the tension to one or more working lines causes each of the outer arms to be hinged at the winding portion and at the distal connection point.

8. A valve repair system for repairing a patient's natural valve, A delivery device having a lumen, An implantable device configured to deliver through the lumen, The anchor portion comprises one or more anchors connected to the joint element and the cap, The one or more anchors are configured to attach to one or more leaflets of a natural heart valve, Each of the anchors comprises a plurality of paddles and paddle frames, The implantable device comprises a paddle frame having an inner frame portion and at least two outer arms, each of which is connected to the inner frame portion at its respective distal connection point and extends proximal to the proximal portion of the device. The paddle frame comprises one or more actuation lines connected thereto, thereby allowing the user to move the paddle frame from an extended position having an extended width to a constricted position having a constricted width by applying tension to the actuation lines, thereby pivoting, articulating, or inwardly bending each of the at least two arms of the paddle frame at or around their respective distal connection points, wherein the extended width is greater than the constricted width. The one or more operating lines extend from the proximal portion through the connecting element to the distal portion, along each of the outer arms from the distal portion to the proximal portion, and radially inward from the proximal portion, and connect to a fixed position on the device relative to the outer arm, A valve repair system in which the anchor is configured to move between an open position and a closed position.

9. The valve repair system according to claim 8, wherein the fixing position is located on the inner frame portion.

10. The valve repair system according to claim 9, wherein the fixed position comprises an opening on the inner frame portion in the proximal portion of the device, and the opening connects the inner frame portion to one of the plurality of paddles.

11. The valve repair system according to claim 8, wherein the aforementioned fixing position is located on a paddle clip.

12. The implantable device according to claim 8, wherein providing the tension to the operating line causes each of the outer arms to pivot or bend inward around each of the distal connection points.

13. The valve repair system according to claim 8, wherein each outer arm has a first portion extending distally from the respective distal connection point, a second portion extending proximal toward the proximal portion, and a winding portion connecting the first portion to the second portion.

14. The valve repair system according to claim 13, wherein providing the tension to the operating line causes each of the outer arms to be hinged at the winding portion and at each of the distal connection points.

Images