Mitral valve spacer device

Abstract

To provide improved devices and methods for treating mitral valve regurgitation. [Solution] The implantable artificial spacer device comprises an inflatable spacer having a plurality of inflatable members, and a frame, the frame may include one or more anchors and one or more clasps. The inflatable spacer may be configured to be positioned between the natural valve leaflets of the heart. The implantable artificial spacer may be positioned in a symmetrical or asymmetrical configuration. The inflatable spacer may be inflatable between a non-inflatable configuration and an inflatable configuration.

Description

[Technical Field]

[0001] This disclosure generally relates to artificial devices and associated methods for assisting the sealing of natural heart valves to prevent or reduce regurgitation, and to devices and associated methods for implanting such artificial devices. [Background technology]

[0002] Natural heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) play a vital role in ensuring an adequate supply of blood in the forward flow of blood through the cardiovascular system. These valves can be damaged and therefore impaired due to congenital malformations, inflammatory processes, infections, or diseases. Such damage to the valves can result in significant cardiovascular impairment or even death. For many years, the most reliable treatment for such damaged valves was surgical valve repair or replacement under open-heart surgery. However, open-heart surgery is highly invasive and prone to numerous complications. Consequently, elderly and frail patients with heart valve defects were often left untreated. More recently, transvascular techniques have been developed to introduce and implant prosthetic devices in a far less invasive manner than open-heart surgery. One specific transvascular technique used to access natural mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein, advancing it through the inferior vena cava, and guiding it into the right atrium. The septum is then punctured, and the catheter is guided into the left atrium, where the procedure can be performed within the left side of the heart. Such transvascular techniques are becoming increasingly popular due to their high success rate.

[0003] A healthy heart has a roughly conical shape that tapers towards the lower apex. The heart consists of four chambers: the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural 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 natural heart valves. The mitral valve comprises an annular portion, which is the ring-shaped part of the natural valve tissue surrounding the mitral valve orifice, and a pair of leaflets, which extend downward from the annular portion into the left ventricle. The mitral annular can form a "D" shape, oval, or other non-circular cross-sectional shape with long and short axes. The anterior leaflet may be larger than the posterior leaflet, and when they close together, a roughly "C" shaped boundary is formed between the abutting free edges of the leaflets.

[0004] When functioning correctly, both the anterior and posterior leaflets function as a one-way valve, allowing blood flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygenated 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 called "ventricular systole" or "systole"), the increased blood pressure in the left ventricle energizes the two leaflets to fuse together, thereby closing the one-way mitral valve. This prevents blood from flowing back into the left atrium and instead pushes it out of the left ventricle through the aortic valve. To prevent these two leaflets from dislocating under pressure and folding back towards the left atrium through the mitral annulus, several fibrous cords called chordae tendineae anchor the leaflets to the papillary muscles of the left ventricle.

[0005] Mitral regurgitation occurs when the natural mitral valve fails to close properly, allowing blood to flow from the left ventricle into the left atrium during the systolic phase of cardiac contraction. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation can have various causes, including leaflet prolapse, papillary muscle dysfunction, and / or stretching of the mitral annulus as a result of left ventricular dilation. Mitral regurgitation in the central portion of the leaflets may be called central jet mitral regurgitation, while mitral regurgitation closer to one of the leaflets' commissures (i.e., where the leaflets meet) may be called eccentric jet mitral regurgitation. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] U.S. Patent Application Publication No. 2018 / 0126124 [Patent Document 2] U.S. Patent No. 10076638 [Patent Document 3] U.S. Patent Application Publication No. 2018 / 0325661 [Patent Document 4] U.S. Patent Application No. 16 / 208,264 [Patent Document 5] U.S. Patent No. 8758432 [Patent Document 6] U.S. Patent No. 8968395 [Patent Document 7] U.S. Patent No. 9414918 [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] Some prior arts for treating mitral regurgitation involve directly suturing portions of the natural mitral valve leaflets together. Other prior arts involve the use of spacers implanted between the natural mitral valve leaflets. Despite these prior arts, there remains a demand for improved devices and methods for treating mitral regurgitation. [Means for solving the problem]

[0008] This specification describes embodiments of artificial devices primarily intended to be implanted in one of the mitral, aortic, tricuspid, or pulmonary valve regions of the human heart, as well as apparatus and methods for implanting such devices. These artificial devices may be used to assist in restoring and / or replacing the function of a defective natural valve.

[0009] An implantable prosthesis may comprise one or more inflatable spacers and a frame having one or more anchors. The inflatable spacers may be configured to be positioned between the natural valve leaflets of the heart. The anchors may be coupled to the inflatable spacers and configured to fix the natural valve leaflets to the inflatable spacers.

[0010] In some embodiments, the frame may further comprise a plurality of clasps. These clasps may be configured to connect to their respective anchors and to secure the natural valve leaflets to the anchors. These clasps may be independently movable between open and closed configurations.

[0011] In a typical embodiment, the implantable prosthesis comprises an inflatable spacer having an internal cavity, the inflatable spacer being inflatable between a non-inflatable configuration and an inflatable configuration, in which the inflatable spacer is positioned between natural heart valve leaflets to reduce regurgitation between them. The implantable prosthesis also comprises a frame comprising at least one anchor configured to be positioned on one side of one of the natural valve leaflets, and a clasp coupled to the anchor and configured to be positioned on the other side of the natural valve leaflet. The clasp is movable between an open position and a closed position. When in the closed position, the clasp is configured to hold a portion of one natural valve leaflet relative to the anchor, and the inflatable spacer is configured to expand from a non-inflatable configuration to an inflatable configuration by filling the internal cavity of the inflatable spacer with an expansion medium.

[0012] In some embodiments, the inflatable spacer is a balloon or other type of inflatable or fillable element (e.g., a fabric pocket). In such embodiments, the inflatable spacer may be inflatable between a non-inflatable configuration and a fully inflated or partially inflated configuration. In some embodiments, the inflatable spacer may be inflated by inflating the internal cavity of the inflatable spacer with an expansion medium. The expansion medium can be fluid and / or non-fluid. Various fluids can be used, such as saline solution, epoxy, blood, and / or other fluids configured to expand. In some embodiments, the fluid can be a gaseous fluid, such as an inert gas (e.g., a gas that does not undergo a chemical reaction or at least an undesirable chemical reaction with the body or components of the artificial spacer device under delivery conditions or after implantation). Suitable gases may include nitrogen, carbon dioxide, helium, and argon, and mixtures thereof. Other gases, such as oxygen, may be included in a gas mixture such as air. Non-fluids can be, for example, a plurality of microbeads, a plurality of pellets, and / or other non-fluid media configured to expand. In some embodiments, both fluid and non-fluid media may be used in combination to inflate the inflatable spacer.

[0013] In some embodiments, the implantable artificial device may further include a source of an inflatable medium. In some embodiments, the inflatable medium can be saline solution. In other embodiments, the inflatable spacer may be configured to inflate from a non-inflatable configuration to an inflatable configuration upon receiving blood.

[0014] In some embodiments, the inflatable spacer may comprise a plurality of inflatable members each having an internal cavity. The plurality of inflatable members can be of separate structures or can be of a single structure having a plurality of chambers. The inflatable members can be individually movable between a fully inflated configuration or a partially inflated configuration and a non-inflated configuration. The inflatable members can be inflated in a symmetric configuration or an asymmetric configuration.

[0015] In some embodiments, the inflatable spacer may comprise a first inflatable member and a second inflatable member. In such embodiments, an asymmetric configuration may include, for example, inflating the first inflatable member to a fully inflated configuration and leaving the second inflatable member in a non-inflated configuration. A symmetric configuration may include, for example, inflating both the first inflatable member and the second inflatable member to a fully inflated configuration.

[0016] In some embodiments, the inflatable spacer may have a substantially cylindrical shape (i.e., having a circular cross-sectional shape in a plane perpendicular to an axis extending from a proximal end portion to a distal end portion of the artificial spacer device). In other embodiments, the inflatable spacer can have a substantially rectangular, annular, semi-circular shape or another shape configured to form a surface against which natural valve leaflets can abut for joining. In some embodiments, the inflatable spacer can have a non-uniform shape configured to fill a space between natural valve leaflets that do not function properly and do not fully join. In some embodiments, the inflatable spacer can have a tapered end portion.

[0017] In some embodiments, the inflatable spacer can include one or more inflation valves through which an inflation medium can enter and / or exit an internal cavity of the inflatable spacer and / or an internal cavity of the inflatable member to inflate or deflate the inflatable spacer and / or the inflatable member.

[0018] In some embodiments, the expansion valve can be a slit valve. The slit valve may have a flexible annular seal through which the expansion shaft of the delivery system can extend. When the expansion shaft is removed from the flexible annular seal, the seal can be biased to a closed state to prevent the expansion medium from exiting and / or entering the internal cavity of the expandable spacer.

[0019] In other embodiments, the expansion valve may be a check valve. The check valve may be configured to prevent the expansion medium from entering the internal cavity of the expandable spacer when the external pressure of the check valve exceeds the opening pressure (or "cracking pressure") of the check valve. When the external pressure exceeds the cracking pressure of the check valve, the valve opens, allowing the medium to enter the internal cavity of the expandable spacer.

[0020] In other embodiments, the expansion valve may be a ball valve, a diaphragm valve, a swing valve, an inline valve, or other types of valves.

[0021] In some embodiments, the inflatable spacer may be formed from a variety of materials, including polymers such as nylon, polyester, polypropylene, polytetrafluoroethylene, stretched polytetrafluoroethylene, silicone, urethane, polycarbonate-based thermoplastic polyurethane, and / or polyether-based thermoplastic polyurethane (TPU).

[0022] In some embodiments, the internal cavity of the inflatable spacer may contain a matrix material. For example, the internal cavity may contain a gel foam, sponge, coagulant, hemostatic matrix, and / or spun collagen hemostatic granules. In such embodiments, the matrix material may expand and / or harden when it comes into contact with the material used to expand the inflatable spacer.

[0023] In some embodiments, the implantable artificial device may further comprise an expandable cover that covers the outer surface of the inflatable spacer. The expandable cover may include a material configured to promote tissue internal growth. In other embodiments, instead of or in addition to the material configured to promote tissue internal growth, the expandable cover may include a material configured to delay or prevent tissue internal growth. In some embodiments, the cover can be elastic. In other embodiments, the inflatable spacer can be inelastic, and the cover can stretch in at least one direction when one of the inflatable members is inflated.

[0024] In some embodiments, the inflatable spacer of an implantable artificial device may have a longitudinal axis extending from the upstream end to the downstream end of the spacer, and the spacer may be configured to form an asymmetric shape with respect to the longitudinal axis when at least partially inflated.

[0025] In another representative embodiment, the implantable prosthesis may include an inflatable spacer positioned between natural heart valve leaflets and configured to reduce regurgitation between them. This spacer comprises a plurality of inflatable members, each having an internal cavity, and each inflatable member is inflatable between a non-inflatable configuration and an inflatable configuration. The implantable prosthesis may also include at least one anchor configured to anchor the inflatable spacer to the natural valve leaflets. Each inflatable member can be independently inflated to its respective inflatable configuration.

[0026] In some embodiments, the inflatable members may include a first inflatable member and a second inflatable member. The first and second inflatable members may be different in size and / or shape when fully inflated.

[0027] In some embodiments, the expandable spacers may form an asymmetrical shape when these expandable members are each expanded with different amounts of expansion medium.

[0028] In some embodiments, the inflatable members may comprise a first inflatable member and a second inflatable member extending radially outward from the longitudinal axis, located on both diametrically aligned sides of the central longitudinal axis of the spacer. In some embodiments, each inflatable member may comprise a first and second main surface located on the opposing side, configured to engage with the natural valve leaflets when the spacer is implanted between the valve leaflets, and each inflatable member has a width measured from the first main surface to the second main surface, and each inflatable member is configured to increase in width upon expansion.

[0029] In some embodiments, the inflatable spacer may comprise a first medium passage and a second medium passage. The first medium passage may be adapted to receive a pressurized expansion medium and allow the medium to flow into a first inflatable member, and the second medium passage may be adapted to receive a pressurized expansion medium and allow the medium to flow into a second inflatable member.

[0030] In some embodiments, the anchor of the inflatable prosthesis may comprise at least two anchors configured to anchor to the natural valve leaflets.

[0031] In another representative embodiment, the implantable prosthesis comprises an inflatable spacer, a plurality of anchors, and a plurality of clasps. The inflatable spacer is configured to be positioned between the natural valve leaflets of the heart. The anchors are coupled to the inflatable spacer and are configured to anchor the inflatable spacer to the natural valve leaflets. The clasps are configured to secure the natural valve leaflets to the anchors and have a fixed end portion and a free end portion. The fixed end portion is coupled to the anchors. The free end portion has a barb. The free end portion is pivotable relative to the fixed end portion between an open configuration and a closed configuration. In the open configuration, the free end portion is axially movable from a first position in which the barb engages with the tissue of the natural valve leaflet to a second position in which the barb is disengaged from the tissue of the natural valve leaflet.

[0032] In another representative embodiment, the assembly comprises an implantable artificial spacer device and a delivery device. The implantable artificial device has an inflatable spacer and a frame having a plurality of anchors, a plurality of clasps, a first collar, and a second collar. The first end portion of the anchors is coupled to the first end portion of the inflatable spacer, and the second end portion of the anchors is coupled to the first collar. The second collar is coupled to the second end portion of the inflatable spacer, and the clasps are coupled to the anchors. The delivery device has a first shaft, a second shaft, and a plurality of clasp control members. The clasp control members are removably coupled to the clasps of the artificial device. The clasp control members move the clasps between an open configuration and a closed configuration.

[0033] In some embodiments, the delivery device further comprises one or more expansion shafts for inflating an inflatable spacer and / or an inflatable member. The expansion shafts are removably coupled to the inflatable spacer and configured to allow a medium used to inflate the inflatable spacer to enter the internal cavity of the inflatable spacer.

[0034] In some embodiments, the delivery device may further include a medium supply source, and the expansion shaft may be removably coupled to the medium supply source. The medium supply source may be configured to supply and / or collect a medium to expand and / or deflate the expandable spacer.

[0035] In some embodiments, the delivery device is configured to move the artificial device between a first configuration in which the anchor is radially compressed and a second configuration in which the anchor is radially expanded and axially compressed, at least partially superimposed on an inflatable spacer to capture the natural valve leaflets between the anchor and the inflatable spacer, by moving a first shaft and a second shaft relative to each other.

[0036] In some embodiments, the delivery device further comprises a clasp control mechanism, to which a clasp control member is removably coupled. The clasp control mechanism is configured such that the clasp control members can be operated simultaneously or independently.

[0037] In another representative embodiment, the assembly comprises an artificial spacer device and a delivery device. The delivery device comprises an outer shaft, an actuating shaft, and a plurality of tethers. The outer shaft comprises a first lumen and a plurality of second lumens arranged radially outward from the first lumen. The actuating shaft extends through the first lumen. The actuating shaft is axially movable relative to the outer shaft and is detachably coupled to the artificial device. The tethers extend through the second lumens and are detachably coupled to the artificial device. By applying tension to these tethers, the implantable artificial device and the outer shaft are moved toward each other. By releasing these tethers, the implantable artificial device and the outer shaft can be separated from each other.

[0038] In some embodiments, each tether is positioned within two of a second lumen, which are circumferentially offset by approximately 180 degrees.

[0039] In some embodiments, the artificial spacer device further comprises a plurality of clasps. These clasps are configured to be coupled to their respective anchors and to secure the natural valve leaflets to the anchors. These clasps are movable between an open configuration and a closed configuration. The outer shaft of the delivery device further comprises a plurality of third lumens arranged radially outward from the first lumen. The delivery device further comprises a plurality of control members extending through the third lumens and detachably coupled to the clasps of the artificial device. By applying tension to the control members, the clasps are moved to the open configuration. By releasing the control members, the clasps can be moved to the closed configuration.

[0040] In some embodiments, each control member is positioned within two of a third lumen, which are offset circumferentially by approximately 180 degrees.

[0041] In another representative embodiment, the assembly comprises an implantable artificial spacer device and a delivery device. The implantable artificial spacer device has an inflatable spacer comprising a plurality of inflatable members, a plurality of anchors, a plurality of clasps, a first collar, and a second collar. The first end portion of the anchor is coupled to the first end portion of the inflatable spacer, and the second end portion of the anchor is coupled to the first collar. The second collar is coupled to the second end portion of the inflatable spacer, and the clasps are coupled to the anchors and are independently movable between open and closed configurations. The delivery device has a first shaft, a second shaft, a plurality of tethers, and a plurality of clasp control members. The first shaft is detachably coupled to the first collar of the artificial device by tethers, the second shaft is detachably coupled to the second collar of the artificial device, and the clasp control members are detachably coupled to the clasps of the artificial device. By acting on the clasp control members, the clasps are moved between open and closed configurations. By applying tension to these tethers, the artificial device and the first shaft can be moved toward each other, and by relaxing these tethers, the artificial device and the first shaft can be moved toward each other.

[0042] In a typical embodiment, a method for implanting an artificial spacer device to improve the jointing of natural heart valve leaflets may include the steps of advancing a delivery device and an implantable prosthesis into the patient's body. The implantable prosthesis comprises an inflatable spacer having at least a first inflatable member and a second inflatable member. The method includes the steps of positioning the inflatable spacer between the natural heart valve leaflets and inflating at least the first inflatable member at least partially with an inflation medium so that the spacer takes on an asymmetric configuration that allows the natural valve leaflets to face each other for jointing.

[0043] In some embodiments, the method may further include the step of anchoring the prosthetic device to the tissue in the heart with anchors of the prosthetic device to support spacers between the natural valve leaflets.

[0044] In some embodiments, the asymmetric configuration of the spacer can be asymmetric with respect to the central longitudinal axis of the spacer extending from the upstream end to the downstream end of the spacer. In some embodiments, the asymmetric configuration can be asymmetric with respect to the transverse axis of the spacer. In some embodiments, the method may further include inflating a second expandable member to form a symmetric configuration that can be faced by natural valve leaflets for joining.

[0045] The various novel features of this disclosure can be used in combination or separately. This summary is provided to introduce in a simplified form one of the concepts that will be further described in the following detailed description. This summary is not intended to identify any important or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The aforementioned and other purposes, features, and advantages of the present invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures. [Brief explanation of the drawing]

[0046] [Figure 1] This figure shows one exemplary embodiment of a delivery assembly comprising a delivery device and an artificial spacer device. [Figure 2] This figure shows one example embodiment of an artificial spacer device. [Figure 3] Figure 2 is a side elevation view of the artificial spacer device, showing the attached cover. [Figure 4A] This is a side elevation view of one embodiment illustrating an artificial spacer device in an asymmetrical expansion configuration. [Figure 4B] Figure 4A is a plan view of the artificial spacer device. [Figure 5A]Figure 4A is a side elevation view of the artificial spacer device in a symmetrical expansion configuration. [Figure 5B] Figure 5A is a plan view of the artificial spacer device. [Figure 6] Figure 2 is a partial cross-sectional view of the artificial spacer device. [Figure 7] Figure 1 is a perspective view of the distal end portion of the delivery assembly, showing an artificial spacer device detachably coupled to the delivery device. [Figure 8] Figure 1 is a perspective view of the distal end portion of the delivery assembly, showing the artificial spacer device removed from the delivery device. [Figure 9] This is a perspective view of the distal end portion of another exemplary delivery assembly, showing an artificial spacer device detachably coupled to a delivery device. [Figure 10] Figure 1 is a plan view of the shaft of the delivery device. [Figure 11] Figure 11, partially illustrated, shows an exemplary procedure in which a delivery assembly is used to repair a natural mitral valve in the heart. [Figure 12] Figure 11, partially illustrated, shows an exemplary procedure in which a delivery assembly is used to repair a natural mitral valve in the heart. [Figure 13] Figure 11, partially illustrated, shows an exemplary procedure in which a delivery assembly is used to repair a natural mitral valve in the heart. [Figure 14] Figure 11, partially illustrated, shows an exemplary procedure in which a delivery assembly is used to repair a natural mitral valve in the heart. [Figure 15] Figure 11, partially illustrated, shows an exemplary procedure in which a delivery assembly is used to repair a natural mitral valve in the heart. [Figure 16] This is a plan view of the artificial spacer device implanted in the natural mitral valve, as shown in Figure 5A. [Figure 17] This is a plan view of the artificial spacer device implanted in the natural mitral valve, as shown in Figure 4A. [Figure 18]This is a side elevation view of one embodiment of an artificial spacer device in an asymmetrical expansion configuration. [Figure 19] Figure 18 is a plan view of the artificial spacer device. [Modes for carrying out the invention]

[0047] General Overview For the purposes of this description, several aspects, advantages, and novel features of embodiments of the disclosure are described therein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects of the various embodiments disclosed, individually and in various combinations and subcombinations. These methods, apparatus, and systems are not limited to any specific aspects or features or combinations thereof, and the disclosed embodiments do not necessarily imply the existence of one or more specific advantages or the resolution of any problem.

[0048] Some operations in the disclosed embodiments are described in a specific sequence for convenience of presentation, but please understand that this style of description is inclusive of reordering unless a specific order is required by the specific wording shown below. For example, operations described sequentially may, in some cases, be performed in a different order or simultaneously. Furthermore, for the sake of simplification, the accompanying diagrams may not show various ways in which the methods disclosed may be used in combination with other methods. In addition, this description sometimes uses terms such as “achieve” or “achieve” to describe the methods disclosed. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and will be readily apparent to those skilled in the art.

[0049] In this application and claims, the singular forms “a, an” and “the” include the plural unless otherwise explicitly stated in the context. Furthermore, the term “includes” means “equipped with.” Furthermore, the term “combined” broadly means physically, mechanically, chemically, magnetically, and / or electrically combined or linked, and does not exclude the presence of intermediate elements between the combined or associated items unless a specific antonym is used.

[0050] In this specification, the term “proximal” refers to a location, orientation, or part of the device that is closer to the user and further from the implantation site. In this specification, the term “distal” refers to a location, orientation, or part of the device that is further from the user and closer to the implantation site. For example, proximal motion of the device is the movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), and distal motion of the device is the movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms “longitudinal” and “axial” refer to axes extending in the proximal and distal directions, respectively, unless otherwise specified.

[0051] In this specification, the term “approximately” means any number given and any number within 10% of a given number. For example, “approximately 100 degrees” means any number between 90 and 110 degrees (including 90 and 110 degrees).

[0052] Exemplary Embodiments This specification describes embodiments of artificial spacer devices primarily intended for implantation in one of the mitral, aortic, tricuspid, or pulmonary valve regions of the human heart, as well as apparatus and methods for implanting such artificial spacer devices. These artificial spacer devices may be used to assist in restoring and / or replacing the function of a defective natural valve.

[0053] The artificial spacer device may form a delivery assembly by being coupled to a delivery device. The delivery device may be used to percutaneously deliver, position, and / or fix the artificial spacer device within the patient's natural heart valve region.

[0054] Figure 1 shows one exemplary embodiment of a delivery assembly 100 and its components. The delivery assembly 100 may comprise an artificial spacer device 102 and a delivery device 104. The delivery device 104 may comprise a plurality of catheters and catheter stabilizers. For example, in the illustrated embodiment, the delivery device 104 comprises a first catheter 106, a second catheter 108, a third catheter 110, and a catheter stabilizer 112. The second catheter 108 extends coaxially through the first catheter 106, and the third catheter 110 extends coaxially through the first catheter 106 and the second catheter 108. The artificial spacer device 102 may be removably coupled to the distal end portion of the third catheter 110 of the delivery device 104, as will be further described below.

[0055] In the illustrated embodiment, the delivery device 104 is configured to implant the artificial spacer device 102 within the natural mitral valve, for example, via a transseptal delivery approach. In other embodiments, the delivery device 104 may be configured to implant the artificial spacer device 102 in the aortic valve region, tricuspid valve region, or pulmonary valve region of the human heart. The delivery device 104 may also be configured for various delivery methods, including transseptal, transaortic, transventricular, and so on.

[0056] The first catheter 106 and the second catheter 108 may be used, for example, to access the implantation site (e.g., the natural mitral valve region of the heart) and / or to position the third catheter 110 at the implantation site.

[0057] The first catheter 106 and the second catheter 108 may each comprise a first sheath 114 and a second sheath 116, respectively. The first catheter 106 and the second catheter 108 may be configured such that these sheaths 114 and 116 are maneuverable. Further details regarding the first catheter 106 can be found, for example, in Patent Document 1. Further details regarding the second catheter 108 can be found, for example, in Patent Document 2.

[0058] Referring further to Figure 1, the delivery device 104 may also include a third catheter 110 as described above. The third catheter 110 may be used, for example, to deliver, manipulate, position, and / or deploy the artificial spacer device 102 at the implantation site. The third catheter 110 may include an internal shaft or operating shaft 118, a coupler 120, an external shaft 122, a handle 124, and a clasp control member 126. The proximal end portion 122a of the external shaft 122 may be coupled to the handle 124 and extend distally from the handle 124. The distal end portion 122b of the external shaft 122 may be coupled to the coupler 120, which may be detachably coupled to the proximal end portion of the artificial spacer device 102. The proximal end portion 118a of the operating shaft 118 may be coupled to the operating knob 128. The actuation shaft 118 extends distally from the knob 128, passes through the handle 124, the outer shaft 122, and the coupler 120. The actuation shaft 118 can be movable relative to the outer shaft 122 and the handle 124 (e.g., axially and / or rotationally). The distal end portion of the actuation shaft 118 can be detachably coupled to the distal end portion of the artificial spacer device 102. The clasp control member 126 extends through the handle 124 and the outer shaft 122 and can be axially movable relative to them. The clasp control member 126 can also be axially movable relative to the actuation shaft 118. The clasp control member 126 can be detachably coupled to the artificial spacer device 102.

[0059] In a particular embodiment, the delivery device 104 may include one or more expansion shafts (not shown). These expansion shafts can be removably coupled to the artificial spacer device 102 and be in fluid communication. This allows an expansion medium (e.g., saline solution) to flow from a medium source (e.g., a reservoir) through the expansion shafts to the artificial spacer device 102 to expand the artificial spacer device 102, and / or flow from the artificial spacer device 102 through the expansion shafts back to the medium source to deflate the artificial spacer device 102. In some embodiments, the expansion shafts can extend through and / or be integrally formed with the third catheter 110.

[0060] The components of the delivery device 104 can be formed from a variety of materials, including metals and polymers. For example, in a particular embodiment, the proximal end portion 122a of the outer shaft 122 may be made of stainless steel, while the distal and intermediate portions may be made of PEBA (e.g., PEBAX®). The outer shaft 122 may also be provided with an outer cover or coating, such as a reflowed polymer, covering these portions.

[0061] The delivery device 104 can be removably coupled to the artificial spacer device 102. In some embodiments, such as those shown in Figure 1, a coupler 120 may be used to couple the artificial spacer device 102 to a portion of the outer shaft 122. In other embodiments, the artificial spacer device 102 may be coupled to the delivery device 104 by a plurality of tethers. Couplers and tethers will be described in more detail later.

[0062] Generally, an artificial spacer device comprises a frame having one or more anchors and an inflatable spacer. In some embodiments, the inflatable spacer may comprise multiple inflatable members, as will be described in more detail later. In some embodiments, the frame may further comprise at least one clasp and at least one collar. In some embodiments, the frame may comprise multiple anchors and / or multiple clasps.

[0063] Figures 1 to 3 show an exemplary embodiment of the artificial spacer device 102 and its components. Referring next to Figure 2, the artificial spacer device 102 may include a frame 130 coupled to an inflatable spacer 132.

[0064] Referring to Figure 6, the frame 130 may comprise one or more anchors 134 (for example, two in the illustrated embodiment). In some embodiments, the frame 130 may further comprise a plurality of clasps 136 (for example, two in the illustrated embodiment), a first collar 138 located at the distal end of the artificial spacer device 102, and a second collar 140 located at the proximal end of the artificial spacer device 102. In some embodiments, the frame 130 may omit one or more of these elements, for example, the clasps 136 and / or the first collar 138 and the second collar 140 may be omitted.

[0065] The anchors 134 and / or clasps 136 of the frame 130 may be configured to secure the artificial spacer device 102 to one or more of the natural valve leaflets so that the inflatable spacer 132 is positioned between the natural valve leaflets (see, for example, Figure 13). The anchors 134 may be configured to be positioned behind the natural valve leaflets (e.g., on the ventricular side) when implanted so that the anchors 134 anchor the inflatable spacer 132 to the natural valve leaflets (see, for example, Figure 14). In some embodiments, the anchors 134 and the inflatable spacer 132 may be configured so that the natural valve leaflets are trapped between the anchors 134 and the inflatable spacer 132.

[0066] The anchor 134 can be configured to move between various configurations by axially moving the first collar 138 and therefore the anchor 134 relative to the inflatable spacer 132 along a longitudinal axis extending between the first end portion 132a and the second end portion 132b of the inflatable spacer 132. For example, the anchor 134 can be positioned in a substantially linear, non-folding configuration where the joint portion 134c of the anchor is located adjacent to the longitudinal axis of the inflatable spacer 132 (e.g., Figure 11). Alternatively, the anchor 134 can be positioned in a fully folded configuration by moving the first collar 138 toward the inflatable spacer 132 (e.g., Figure 9).

[0067] In some embodiments, the clasp 136 is attached to the anchor 134. The clasp 136 may be configured to capture natural valve leaflets and secure them to the anchor 134, for example, as shown in Figure 13. In some embodiments, the clasp 136 is operable independently or separately so that each natural valve leaflet can be captured in succession.

[0068] Referring again to Figure 6, the clasp 136 may comprise a mounting portion 136a and an arm portion 136b. The mounting portion 136a may be attached to the anchor 134 in various ways, such as by using sutures, adhesives, fasteners, welding, and / or coupling means. The arm portion 136b is pivotable between an open configuration and a closed configuration. In the open configuration, the mounting portion 136a and the arm portion 136b pivot away from each other so that the natural valve leaflet can be positioned between the mounting portion 136a and the arm portion 136b. In the closed configuration, the mounting portion 136a and the arm portion 136b pivot toward each other, thereby clamping the natural valve leaflet between the mounting portion 136a and the arm portion 136b.

[0069] In some embodiments, the clasp 136 may be formed from a shape memory material such as nitinol, stainless steel, and / or a shape memory polymer. In some embodiments, the clasp 136 may be formed by laser cutting a flat sheet material (e.g., nitinol) and then shaping the clasp 136.

[0070] Referring again to Figure 2, in some embodiments the artificial spacer device 102 may further comprise anchor extension members 142 (two in Figure 2, for example). The anchor extension member 142 may be configured as a loop having a first end portion, i.e., a fixed end portion 142a, coupled to the first collar 138 and extending from the first collar 138, and a second end portion, i.e., a free end portion 142b, disposed on the opposite side of the fixed end portion 142a. The anchor extension member 142 may be configured to extend circumferentially around the inflatable spacer 132 further than the anchor 134.

[0071] The anchor extension member 142 may be further configured such that, when the artificial spacer device 102 is in a folded configuration, its free end portion 142b is positioned adjacent to the joint portion 134c of the anchor 134 in the axial direction and between the first portion 134a and the second portion 134b of the anchor 134 in the radial direction (for example, Figure 2).

[0072] By configuring the anchor extension member 142 in this way, the surface area is increased compared to the case with only the anchor 134. This can make it easier to capture and fix the natural valve leaflets, for example. Furthermore, the increased surface area allows the clamping force of the anchor 134 and the anchor extension member 142 to be distributed over a relatively wider surface area of ​​the natural valve leaflets, thereby further protecting the natural valve leaflet tissue.

[0073] In some embodiments, the second collar 140 and / or inflatable spacer 132 may include a hemostatic sealing member (not shown) configured to reduce or prevent blood from passing through the second collar 140 and / or into the inflatable spacer 132. For example, in some embodiments, the sealing member may include a plurality of flexible flaps. These flaps may be configured to pivot from a sealed configuration to an open configuration, thereby allowing a delivery device to extend through the second collar 140. When the delivery device is removed, the flaps may be configured to return from the open configuration to a sealed configuration.

[0074] In other embodiments, the artificial device may include a third collar 144 coupled to the distal end portion of the inflatable spacer 132 (see, for example, Figure 7), as shown in Figures 7 and 8. The anchor 134 may be coupled to the third collar 144 by integrally forming the third collar 144 and the anchor 134 as a single integral component (see, for example, Figures 7 and 8). In other embodiments, the third collar 144 and the anchor 134 may be joined together by welding, fasteners, adhesives, and / or other bonding means. In yet another embodiment, the third collar 144 may be omitted, and the anchor 134 may be directly coupled to the first end portion 132a of the inflatable spacer 132.

[0075] Referring again to Figure 2, the frame 130 may be coupled to the inflatable spacer 132. The frame 130 may be coupled to the inflatable spacer 132 by fasteners, adhesives, sutures, and / or other means of coupling. In some embodiments, the first end portion 134a of the anchor 134 may be coupled to the first end portion 132a of the inflatable spacer 132 and extending from this first end portion 132a, and the second end portion 134b of the anchor 134 may be coupled to the first collar 138. The second collar 140 may be coupled to the second end portion 132b of the inflatable spacer 132.

[0076] The inflatable spacer 132 may be configured to be positioned within the natural valve orifice to fill the space between improperly functioning natural valve leaflets that do not naturally align completely. Thus, the inflatable spacer 132 may provide a more effective seal between the natural valve leaflets and help prevent or minimize regurgitation (e.g., mitral regurgitation). In some embodiments, the inflatable spacer 132 may have a shape and / or structure that allows the natural valve leaflets to close around the sides of the inflatable spacer 132, thereby preventing regurgitation of blood (e.g., blood flowing back from the left ventricle into the left atrium during ventricular systole).

[0077] The inflatable spacer 132 can expand and contract between a non-expandable configuration and an expandable configuration. The non-expandable configuration may be used, for example, to reduce the radial profile of the artificial spacer device 102 as it is advanced through the patient's blood vessel to the implantation site. The expandable configuration may be used, for example, to prevent regurgitation through the natural valve leaflets.

[0078] In some embodiments, the inflatable spacer 132 can be expanded by introducing an expansion medium, such as an expansion fluid and / or a non-fluid. The expansion fluid can be, for example, saline solution, curable epoxy, blood, and / or other materials configured to expand. In contrast, the spacer 132 can be deflated by removing the fluid from the spacer. In some embodiments, if the material for fabricating the inflatable spacer 132 is sufficiently robust, the expansion fluid can be a gaseous fluid, such as an inert gas (a gas that does not undergo chemical reactions or at least undesirable chemical reactions with the body or components of the artificial spacer device, for example, under delivery conditions or after implantation). Suitable gases may include nitrogen, carbon dioxide, helium, and argon, and mixtures thereof. Other gases, such as oxygen, may be included in a gas mixture such as air. The non-fluid can be, for example, a plurality of pellets and / or microbeads. Embodiments using a non-fluid to expand the inflatable spacer 132 may, for example, allow for the use of a relatively simple seal. This is because the seal does not need to maintain fluid pressure and / or hemostasis of the expansion fluid in order to hold the expandable spacer 132 in the expansion configuration. Fluid combinations (e.g., saline and curable epoxy), non-fluid combinations (e.g., microbeads and pellets), and / or fluid and non-fluid combinations (e.g., saline and microbeads) can be used to expand the expandable spacer 132.

[0079] In some embodiments, the inflatable spacer 132 may be impermeable to blood. In other embodiments, the inflatable spacer 132 may be partially or completely permeable to blood in order to fill the internal cavity or internal chamber 146 (see Figure 6) of the inflatable spacer 132 with blood.

[0080] In some embodiments, the inflatable spacer 132 can be a balloon or other type of inflatable or fillable element. The inflatable spacer 132 can be made of any suitable material. In some embodiments, these materials are expandable, flexible, shape-conforming, and / or stretchable, because the amount of medium placed in the hollow interior portion of the inflatable spacer is increased. Suitable materials include polymers such as nylon, polyester, polypropylene, polytetrafluoroethylene (PTFE), stretched polytetrafluoroethylene, silicone, urethane, polycarbonate-based thermoplastic polyurethane (TPU), and / or polyether-based thermoplastic polyurethane (TPU).

[0081] In some embodiments, the inflatable spacer 132 may be composed of a cloth or fabric such as polyethylene terephthalate (PET), velour, and / or other suitable fabric or textile. In some examples, the cloth or fabric can form pockets configured to fill and thus expand the inflatable spacer 132 by receiving a non-fluid expansion medium (e.g., microbeads and pellets).

[0082] In certain embodiments, the spacer 132 is formed from a single material layer 133 (e.g., a polymer layer) shaped to define an internal cavity 146. In some embodiments, this layer 133 is substantially inelastic, such that it does not stretch when filled with an expanding medium. In other embodiments, the layer 133 is elastic and can stretch when inflated with an expanding medium. In alternative embodiments, the spacer 132 may comprise multiple layers forming a laminate structure.

[0083] The use of the inflatable spacer 132 allows the artificial spacer device 102 to be inserted with a minimum profile (e.g., diameter) and then inflated once placed in a selected location (e.g., within the heart). For example, the use of the inflatable spacer may create a better sealing surface against the natural valve leaflets and / or reduce mitral regurgitation.

[0084] The degree to which the inflatable spacer 132 is inflated can be changed. For example, the inflatable spacer 132 can be inflated from a non-inflated configuration to a diameter of 2 mm to 20 mm, and in some embodiments to a diameter of 5 mm to 15 mm. In certain embodiments, the inflatable spacer 132 can be inflated to 5 mm, 7.5 mm, 10 mm, and / or 12 mm. For example, this adjustable inflatability allows the inflatable spacer 132 to be adjusted within the patient's body during the implantation procedure to accommodate the anatomical variability of a particular patient. Furthermore, this reduces the need to remove and / or replace an improperly sized artificial spacer device during the delivery procedure of larger or smaller devices. Also, because the spacer can be adjusted to various sizes, a tighter fit is possible. For example, the inflatable spacer 132 of this artificial spacer device 102 can be inflated to 8 mm, while other devices are only available in sizes of 5 mm or 10 mm, and the latter devices are either too small or too large for an 8 mm backflow port. In some embodiments, the size of the spacer 132 can be adjusted by adding or removing expansion medium in a later procedure. For example, if the reflux opening enlarges over the patient's lifetime, the spacer 132 can be further expanded in a later procedure.

[0085] Furthermore, the adjustable properties of the expandable spacer 132 alleviate the need to use multiple prosthetic devices in a single backflow position. For example, using only one prosthetic spacer device can make the implantation procedure relatively easier, reduce the risk of device displacement, and / or mitigate undesirable interference with the anterograde flow passing through the valve.

[0086] In some embodiments configured for implantation within the natural mitral valve, the inflatable spacer 132 may have an atrial end portion, i.e., an upper end portion, positioned within or adjacent to the left atrium of the heart; a ventricular end portion, i.e., a lower end portion, positioned within or adjacent to the left ventricle of the heart; and a central portion extending between the natural mitral valve leaflets.

[0087] Referring to Figure 6, the inflatable spacer 132 may have an internal cavity 146, and the operating shaft 118 may extend through this internal cavity 146. In another embodiment, the inflatable spacer 132 may include an internal shaft extending through the cavity 146 from a first end 132a to a second end 132b of the inflatable spacer 132, which defines an internal lumen through which the operating shaft 118 may extend.

[0088] As shown in Figures 1 to 3, in some embodiments, the inflatable spacer 132 may have a symmetrical shape (e.g., oval, cylindrical, rectangular, etc.) with respect to the transverse and / or longitudinal axis of the artificial spacer device 102 when fully or partially inflated. In other embodiments, the inflatable spacer 132 may have an asymmetrical shape with respect to the transverse and / or longitudinal axis of the artificial spacer device 102 when fully or partially inflated. In a partially inflated state, the inflatable spacer 132 may be partially filled with the expansion medium, allowing the shape of the inflatable spacer 132 to change in its original location, such as when the natural mitral valve leaflets join around the inflatable spacer.

[0089] The inflatable spacer 132 can have a variety of shapes. In some embodiments, the inflatable spacer 132 may have a cylindrical shape (i.e., a circular cross-sectional shape in a plane perpendicular to the longitudinal axis of the artificial spacer device 102). In other embodiments, the inflatable spacer 132 may be substantially rectangular, elliptical, annular, semicircular, or have another shape configured to form a surface that natural valve leaflets can come into contact with for joining. In some embodiments, the inflatable spacer 132 may have a heterogeneous shape configured to fill the space between improperly functioning natural valve leaflets that do not fully join. In some embodiments, the inflatable spacer may have tapered end portions and / or tapered side portions. In certain embodiments, when the spacer 132 is inflated, the spacer has a variable width or diameter along its length, with the maximum diameter or maximum width located in the intermediate portion 132c between the first end 132a and the second end 132b of the spacer. The spacer is tapered from the intermediate portion 132c toward the first and second ends, and these ends have a diameter or width smaller than the diameter of the intermediate portion.

[0090] Referring to Figures 4A to 5B, typical embodiments of an artificial spacer device 102 for improving the joining of natural or artificial heart valve leaflets are shown. This artificial spacer device 102 may comprise an inflatable spacer 132 comprising a plurality of inflatable members 200 (e.g., two to four members), each inflatable member 200 having an internal cavity or internal chamber that can be filled with an expansion medium. These inflatable members 200 may be separate structures or may be a single structure having a plurality of chambers. The inflatable members 200 may be coupled to a frame 130, and in some embodiments, the inflatable members may be coupled together. In Figures 4A to 5B, the anchor extension member 142 is not shown in order to better illustrate the inflatable members.

[0091] For example, in Figures 4A to 5B, the artificial spacer device 102 has an inflatable spacer comprising two inflatable members 200a and 200b. The first inflatable member 200a and the second inflatable member 200b can be part of a single inflatable body or inflatable structure, such as a balloon. For example, the single body may be formed from a single polymer layer or thin structure, and then fluidly separated into multiple chambers by joining the two sides of the body together (e.g., by welding, or by bonding using an adhesive such as epoxy). In other embodiments, the first inflatable member 200a and the second inflatable member 200b may comprise a separate inflatable body or inflatable structure (e.g., a separate balloon), which can be appropriately fixed to each other (e.g., by mechanical means and / or by the use of adhesives and / or other types of bonding mechanisms). The spacer device in the illustrated configuration comprises two inflatable members, but in other embodiments, the spacer device can have any number of inflatable members, such as three, four, five, six, or more.

[0092] In some embodiments, these inflatable members can be in fluid communication with each other, regardless of whether they are different parts of the same inflatable structure or separate inflatable structures; however, in other embodiments, the inflatable members can be fluidly separated or sealed from each other. When the inflatable members are in fluid communication with each other, they can be shaped or configured to expand to different volumes to achieve an overall asymmetrical shape, as will be discussed further below.

[0093] In some embodiments, the spacer 132 defines a longitudinally extending opening or lumen between the inflatable members 200, extending from collar 140 to collar 138, and the actuarial shaft 118 may extend through this longitudinally extending opening or lumen. In some embodiments, the inflatable members 200 may be coupled to a centrally positioned shaft or sleeve 206 (Figure 4A), and the actuarial shaft 118 may extend through this shaft or sleeve 206. The shaft 206 may be coupled to the inflatable members 200 in various ways, such as using fasteners, sutures, adhesives, and / or other bonding means. The shaft 206 may extend axially from one collar 138 to the other collar 140.

[0094] Referring further to Figures 4A to 5B, the inflatable members 200 can extend laterally from both sides of the shaft 206 and collars 138 and 140 when inflated, and can be flush with or at least substantially flush with the shaft 206 when not inflated. For example, in Figures 4A to 4B, the inflatable member 200a is inflated and extends from the shaft 206 in length dimension L (measured from the center or midpoint of the artificial spacer device 102 to the outer edge 210 of the inflatable member 200) and width dimension W (measured between the two main surfaces 202 and 204), while the inflatable member 200b is not inflated and is substantially flush with the shaft 206. In Figures 5A to 5B, both inflatable members 200a and 200b are inflated. These inflatable members 200a, 200b may be configured such that the degree to which each inflatable member 200a, 200b expands in length L, width W, and / or height H differs between the expanded and non-expanded configurations from those shown in Figures 4A to 5B. For example, one or more of the inflatable members may expand to a greater or lesser degree than the inflatable member 200a shown in Figures 4A to 4B when expanded, and one or more of the inflatable members may expand to a greater or lesser degree than the inflatable member 200b shown in Figures 4A to 4B when non-expanded.

[0095] The inflatable members 200 can be partially inflated, fully inflated, and / or deflated independently of each other. In some embodiments, each inflatable member 200 can be deflated and / or partially or fully inflated independently of each other to form various symmetrical or asymmetrical configurations. Figures 4A and 4B show an exemplary asymmetrical configuration achieved by inflating the first inflatable member 200a into an inflated configuration and keeping the second inflatable member 200b in a non-inflated configuration.

[0096] Figures 5A and 5B show the device in an exemplary symmetrical configuration achieved by inflating both the first inflatable member 200a and the second inflatable member 200b into an inflatable configuration. Figures 4 and 5 show the first inflatable member 200a and the second inflatable member 200b having substantially the same size and shape, although in other embodiments, the first inflatable member 200a may have a different shape and / or configuration from the second inflatable member 200b. For example, this may provide further adjustability to the artificial spacer device 102.

[0097] Referring to Figures 4A and 4B, when fully inflated, each member 200a, 200b may have a height H (measured from the upstream end to the downstream end of the member), a length L (measured radially from the center or midpoint of the artificial spacer device 102 to the outer edge of the member), and a width W (measured between the two main surfaces 202, 204 of the member). In embodiments where one or more of these dimensions H, L, and / or W are not constant, these dimensions may be nominal values ​​or average values, or may be measured at a specific location. For example, if the width W is smaller at the outer edge than at one or more other locations, the width W may be measured at the midpoint of the length (i.e., L / 2).

[0098] In some embodiments, members 200a and 200b have the same size and shape when fully expanded. In some embodiments, members 200a and 200b have the same shape when fully expanded, but one or more of the dimensions H, L, or W of one of these members differ from the other. For example, one of the members may be longer, wider, and / or taller than the other. In yet another embodiment, members 200a and 200b may each have different shapes when fully expanded. For example, one of these members may have the shape shown in Figures 4A to 5B, while the other member may have a different shape, such as a circular or elliptical cross-section.

[0099] In embodiments configured for implantation within the natural mitral valve, the height H may correspond approximately to the superior / inferior anatomical direction, the length L to the medial / lateral anatomical direction, and the width W to the anterior / posterior anatomical direction. In embodiments configured for implantation at other locations, the height H, length L, and width W may correspond to other anatomical directions.

[0100] In certain embodiments, the height H can be in the range of approximately 2.5 mm to approximately 20 mm, more specifically in the range of approximately 5 mm to approximately 15 mm, and in specific cases, 11 mm; the length L can be in the range of approximately 1 mm to approximately 20 mm, more specifically in the range of approximately 2.5 mm to approximately 15 mm, and in specific cases, 10 mm; and the width W can be in the range of approximately 1 mm to approximately 15 mm, more specifically in the range of approximately 2 mm to approximately 10 mm, and in specific cases, 5 mm.

[0101] In some embodiments, the length L can be greater than the width W when the expandable member 200 is expanded.

[0102] The symmetrical and asymmetrical shapes and configurations of the inflatable spacers provide variability in the positioning of the artificial spacer device 102 along the natural valve leaflet. Based on intracellular ultrasound imaging, a physician can determine whether symmetrical or asymmetrical inflation of the artificial spacer device 102 is more advantageous for the patient. In patients where anatomical considerations limit the possible implantation positions, the ability to asymmetrically inflate the inflatable spacer (e.g., by inflating one or more inflatable members 200) can reduce the need for additional implants and thus mitigate the associated risks. For example, a physician can implant the artificial spacer device 102 relative to the natural valve leaflet at an offset position from the regurgitation position (e.g., toward the A1 / P1 position of the natural valve leaflet when implanted in the mitral valve) (e.g., toward the A1 / P1 position of the natural valve leaflet when implanted within the mitral valve), and asymmetrically inflate the inflatable spacer, thereby allowing the inflatable spacer to block regurgitation at the A2 / P2 position but not at the A1 / P1 position. Furthermore, the adjustable nature of the expandable spacer allows for repositioning and / or readjustment of the artificial spacer device 102 during implantation, as will be described in more detail below. This also makes it possible to adjust the artificial spacer device 102 after the initial implantation (for example, during a later procedure).

[0103] By inflating the inflatable members 200a and 200b to different sizes, an asymmetry with respect to the longitudinal axis of the artificial device is created. In other embodiments, the artificial device 102 may have inflatable members configured perpendicular to the longitudinal axis (an axis parallel to the height H) to provide an asymmetry with respect to the transverse axis (an axis parallel to the length L) instead of, or in addition to, having longitudinal asymmetry. For example, in some embodiments, the artificial device may have an inflatable member at the upstream end of the device and a separate inflatable member at the downstream end of the device. These inflatable members located at the upstream and downstream ends may each be inflated to different volumes to achieve an asymmetry with respect to the transverse axis that bisects the artificial device midway between the upstream and downstream ends of the device.

[0104] As described above, the spacer device can be removably coupled to the delivery device 104. In some embodiments, the delivery device 104 can be used to inflate and / or deflate the expandable spacer.

[0105] In some embodiments, a second collar 140 may facilitate the inflation of the artificial spacer device 102 by a delivery device 104. Referring to Figure 6, the second collar may have a central opening configured to slidably receive, for example, an operating shaft 118, which may be used to deliver an inflation medium to inflate the inflatable spacer 132 during the implantation procedure. For example, the proximal end portion of the operating shaft 118 may be fluidly coupled to a medium supply source and may have one or more lateral openings 147 spaced apart along the length of the portion of the shaft located within the internal cavity 146 of the spacer. The pressurized inflation medium may flow from the medium supply source through the lumen of the operating shaft 118, through the openings 147, and into the inflatable spacer 132.

[0106] In such embodiments, the second collar 140 may include a sealing member (not shown), such as a hemostatic sealing member. In a particular example, the sealing member may be a slit valve formed from an elastomer (e.g., rubber) or other self-sealing material, defining a central opening for receiving the working shaft 118. The slit valve may be housed within the outer ring of the collar 140. If formed from an elastomer material, the central bore of the slit valve may expand to accommodate the passage of the working shaft 118 (or a separate expansion shaft of the delivery device) into the artificial device 102. Once inserted into the central bore, the slit valve may seal around the outer surface of the shaft. When the shaft is withdrawn from the artificial device 102, the central bore of the slit valve closes under the elasticity of the elastomer material.

[0107] In embodiments where the inflatable spacer comprises multiple inflatable members (e.g., two), the operating shaft may be formed having a first lumen and a second lumen, each separately delivering an expansion medium to, for example, a first inflatable member and a second inflatable member. The first lumen may extend through the operating shaft from its proximal end to a first side opening formed in the shaft at a certain position within the first inflatable member. The second lumen may extend through the operating shaft from its proximal end to a side opening formed in the shaft at a certain position within the second inflatable member. In this way, the expansion medium may be delivered simultaneously or sequentially to the first and second inflatable members through separate medium passages. Alternatively, the expansion medium may be delivered to the first and second inflatable members via separate conduits or tubes extending through or away from the collar.

[0108] Referring next to Figure 4A, in some embodiments, another part of the second collar 140 and / or artificial spacer device 102 may be equipped with an expansion valve 151, which may be used to control the flow of expansion medium into the inflatable members 200a, 200b. The expansion valve 151 may be a slit valve, a check valve, and / or another type of valve configured to adjust or control the expansion and / or contraction of the inflatable members.

[0109] In embodiments where the inflatable spacer comprises multiple inflatable members, each inflatable member may have a corresponding expansion valve 151. For example, as shown in Figure 4A, the collar 140 houses a first expansion valve 151a and a second expansion valve 151b, and each expansion valve 151a, 151b controls the flow of expansion medium to each inflatable member 200a, 200b via media passages 153a, 153b which may be formed in the central shaft 206. In some embodiments, the expansion valves 151 may be elastomer slit valves as described above, and may be configured so that each expansion shaft can be inserted through these valves into the media passages 153a, 153b for the delivery of expansion medium to the inflatable members 200a, 200b. In other embodiments, the expansion valves 151a, 151b may be check valves configured to form removable connections to each expansion shaft. For example, each inflation shaft may be screwed into the inflation valve during the delivery and deployment of the artificial valve, and then screwed out of the inflation valve and removed from the patient after the deployment of the artificial device 102.

[0110] In other embodiments, the inflatable spacer of the artificial spacer device 102 may be inflated by regulating blood flow into the spacer rather than introducing an external inflation medium into the body. For example, the inflation valve 151 of the inflatable spacer may be a one-way valve including a check valve, a hemostatic valve, and / or other suitable valves configured to regulate blood flow into the member.

[0111] For example, the inflatable spacer may include a check valve (such as one indicated by a valve 151) housed within, for example, a second collar 140, which is configured to allow blood flow in only one direction through the check valve into the internal cavity / lumen of the inflatable spacer. When the pressure at the inlet end of the check valve reaches a minimum threshold (also called the "cracking pressure"), the check valve may move to an open position, allowing blood to pass through the valve into the internal cavity of the inflatable spacer. For example, the check valve may be configured to have a cracking pressure substantially equivalent to the blood pressure of the patient in whom the spacer device is implanted. In this way, the check valve allows the inflatable spacer to be filled with blood when the check valve is exposed to blood (for example, when the artificial spacer device 102 is exposed from the sheath 116 of the delivery device 104 in the patient's left atrium).

[0112] For implantation of a spacer device within the natural mitral valve, a one-way valve (e.g., a check valve) may be positioned at or near the upstream end of the spacer (e.g., within collar 140) and may have a cracking pressure (e.g., 4 mmHg to 12 mmHg) substantially equivalent to the blood pressure in the left atrium, so that the spacer can be filled with blood flowing from the left atrium to the left ventricle during diastole. Alternatively, a one-way valve (e.g., a check valve) may be positioned at or near the downstream end of the spacer (e.g., within collar 138) and may have a cracking pressure (e.g., 100 mmHg to 140 mmHg) substantially equivalent to the blood pressure in the left ventricle, so that the spacer can be filled with blood flowing from the left atrium to the left ventricle during systole.

[0113] In some embodiments, the check valve can be a ball check valve, a diaphragm check valve, a swing check valve, an inline check valve, or another type of check valve.

[0114] In some embodiments, the inflatable spacer may comprise a structure-forming material and / or gel disposed inside an internal cavity (for example, this material may be an internal coating layer that can fill or partially fill the internal cavity and / or line the outer layer) so that when a medium (e.g., a fluid such as blood, saline solution, epoxy, or gas) enters the internal cavity of the inflatable spacer, the medium comes into contact with the gel, causing the gel to expand and / or harden within the cavity of the inflatable spacer.

[0115] In other embodiments, the internal cavity of the inflatable spacer may be coated and / or filled with a coagulant so that when blood enters the internal cavity of the inflatable spacer, the blood comes into contact with the coagulant and coagulates within the inflatable spacer. For example, the internal cavity 146 of the inflatable spacer 132 may be coated and / or filled with gel foam (e.g., Baxter Gel Foam Plus), hydrogel, sponge (e.g., gelatin or other suitable material), thrombin powder (e.g., Baxter Thrombin powder), hemostatic matrix (e.g., Baxter FloSeal), spun collagen hemostatic granules, and / or any other suitable material. The use of a material that subsequently forms a solid material (or at least a more rigid material) may help to give the inflatable spacer further structural integrity, including resistance to changes (deformation) caused by cardiac contraction and fluid flow around the artificial spacer device 102.

[0116] Referring next to Figure 3, in some embodiments the artificial spacer device 102 may include a cover 152. In some embodiments, the cover 152 may be positioned over the inflatable spacer 132, the anchor 134, and / or the anchor extension member 142. The cover 152 may be configured to prevent and / or reduce blood flow through the artificial spacer device 102, and / or to promote and / or prevent or slow down internal growth of natural tissue. In some embodiments, the cover 152 may be a cloth or fabric such as PET, velour, or other suitable fabric. In some embodiments, the cover 152 may consist of an elastic and / or dynamic material that can stretch in one or two directions to expand and / or contract when the size of the inflatable spacer is adjusted, an expandable and / or contractible knitted material, or a folded or pleated material.

[0117] In other embodiments, instead of or in addition to the fabric, the cover 152 may comprise a coating (e.g., a polymer coating) applied to the artificial spacer device 102. In some embodiments, the cover 152 may comprise an elastomer fabric cover that forms a smooth, biocompatible outer surface to promote tissue growth. This elastomer fabric covering the inflatable spacer 132 can adhere relatively tightly to the spacer when the inflatable spacer 132 is in an uninflated state, and can stretch and expand when the spacer is inflated. In this way, the elastomer fabric provides a smooth outer surface without creases or wrinkles around the spacer when the spacer is not fully inflated or is completely uninflated.

[0118] In some embodiments, a first portion of the cover 152 may be configured to promote tissue internal growth, while a second portion of the cover may be configured to prevent or slow down tissue internal growth. For example, the cover may include a material configured to promote tissue internal growth at a location along the outer surface of the inflatable spacer 132, and a material configured to slow down and / or prevent tissue internal growth near and / or around the anchor 134. In another embodiment, the cover may include a material configured to promote tissue internal growth near and / or around the anchor 134, and a material configured to slow down and / or prevent tissue internal growth along the outer surface of the inflatable spacer 132. This configuration allows the artificial spacer device 102 to be fixed in place by internal growth covering the anchor 134, while internal growth covering the central portion of the artificial spacer device is prevented or minimized, thereby reducing the possibility of mitral stenosis. An artificial spacer device 102 according to one embodiment is shown without a cover in Figure 2 and with a cover 152 in Figure 3.

[0119] In embodiments in which the artificial spacer device 102 includes a cover 152, the cover 152 may be configured to expand by the expansion of the inflatable spacer 132 and the movement of the anchor 134, clasp 136, and anchor extension member 142 so that the cover 152 remains in a position adjacent to the artificial spacer device 102 and does not swarm or otherwise become entangled with the components of the artificial spacer device.

[0120] As described above, the artificial spacer device 102 can be detachably coupled to the delivery device 104 by various means. For example, the delivery device can be detachably coupled to the delivery device by one or more of the following: an operating shaft, an expansion shaft, a clasp control member, a coupler, and / or a number of tethers.

[0121] Referring to Figure 10, the outer shaft 122 of the delivery device 104 may comprise a plurality of axially extending lumens, each consisting of an operating shaft lumen 154, a plurality of control member lumens 156 (for example, four in the illustrated embodiment), and one or more expansion shaft lumens 158 (for example, two in the illustrated embodiment). In some embodiments, the outer shaft 122 may comprise five or more (e.g., six) or three or fewer (e.g., two) control member lumens 156. In some embodiments, the outer shaft may comprise three or more (e.g., three) or one or fewer (e.g., one) expansion shaft lumens 158.

[0122] The actuation shaft lumen 154 may be configured to receive the actuation shaft 118, the control member lumen 156 may be configured to receive one or more clasp control members 126, and the expansion shaft lumen 158 may be configured to receive one or more expansion shafts (not shown). These lumens 154, 156, and 158 may be configured such that the actuation shaft 118, the clasp control members 126, and the expansion shafts can move relative to each lumen 154, 156, and 158 (e.g., axially and / or rotationally). In certain embodiments, the lumens 154, 156, and 158 may have liners or coatings configured to reduce friction within these lumens. For example, the lumens may have liners made of PTFE.

[0123] In some embodiments, as shown in Figures 7-8, the actuarial shaft 118 of the third catheter 110 may be removably coupled to the first collar 138 of the artificial spacer device 102. For example, the distal end portion 118b of the actuarial shaft may have a male thread configured to removably engage with the female thread of the first collar 138. Thus, the actuarial shaft 118 is removably fixed to the first collar 138 by rotating the actuarial shaft 118 in a first direction (e.g., clockwise) relative to the first collar 138. The actuarial shaft 118 is removed from the first collar 138 by rotating the actuarial shaft 118 in a second direction (e.g., counterclockwise) relative to the first collar 138.

[0124] Referring next to Figure 7, in some embodiments, the third catheter 110 may be removably coupled to the second collar 140 of the artificial spacer device 102 by a coupler 120. The coupler 120 may comprise a plurality of flexible arms 160 and a plurality of stabilizers 162. The coupler 120 may be removably coupled to the artificial spacer device 102 by inserting the stabilizers 162 of the coupler into the opening 141 (Figure 8) of the tab 143 of the second collar 140. The flexible arms 160 may be configured to removably couple the tab 143. Further details regarding the coupler 120 can be found, for example, in Patent Documents 3 and 4.

[0125] In some embodiments in which the delivery device comprises separate expansion shafts for delivering an expansion medium to multiple expansion members, the distal end portion of the expansion shaft may be used instead of or in addition to the stabilizer member 162, and the sealing member in the collar 140 that receives the shaft may be used instead of or in addition to the opening in the second collar 140.

[0126] In other embodiments, as shown in Figure 9, the artificial spacer device 102 may be detachably coupled to the delivery device 104 using a plurality of tethers 164. These tethers 164 may extend through a plurality of tether lumens 166 (e.g., two in Figure 10) of the outer shaft. The tethers 164 may be detachably coupled to the artificial spacer device 102. The second collar 140 may have connector members (not shown) for receiving the tethers 164. These connector members may have, for example, openings, holes, and / or other suitable means for connecting the tethers 164 to the second collar 140. By applying tension to the tethers 164, the artificial spacer device 102 and the outer shaft 122 are moved in the direction of each other. By releasing the tethers 164, the artificial spacer device 102 and the outer shaft 122 can be separated from each other.

[0127] Figures 11–17 show a delivery device 104 used, for example, to implant an artificial spacer device 102 within the natural mitral valve 300 of the heart 302 using a transseptal delivery approach. Although not shown, a guidewire may be inserted into the patient's blood vessel (e.g., femoral vein) via a guide sheath. The guidewire may advance through the femoral vein, through the inferior vena cava, into the right atrium, through the atrial septum 304 (e.g., via the fossa ovalis), and into the left atrium 306. As shown in Figure 11, the first sheath 114 of the first catheter 106 may be advanced along the guidewire so that the distal end portion of the first sheath 114 is positioned within the left atrium 306.

[0128] With the artificial spacer device 102 coupled to the third catheter 110 (for example, as shown in Figure 7) and configured in a radially compressed delivery configuration, the artificial spacer device 102 can be loaded into the second sheath 116 of the second catheter 108, thereby holding the artificial spacer device 102 in the delivery configuration. In some embodiments, the radially compressed delivery configuration can be an axially extended configuration (similar to the configuration shown in Figure 11, for example). In other embodiments, the radially compressed delivery configuration can be an axially shortened configuration (similar to the configuration shown in Figure 9, for example). The second catheter 108 can then be advanced through the first catheter 106 together with the artificial spacer device 102 and the third catheter 110, as shown in Figure 11, so that the distal end portion of the second sheath 116 is exposed from the distal end portion of the first sheath 114 and positioned in the left atrium 306.

[0129] Referring further to Figure 11, the artificial spacer device 102 can be exposed from the second sheath 116 by advancing the outer shaft 122 and working shaft 118 of the third catheter 110 distally relative to the second sheath 116 and / or retracting the second sheath 116 relative to the outer shaft 122 and working shaft 118, thereby pushing the anchor 134 out of the second sheath 116. Once exposed from the second sheath 116, the anchor 134 can be folded by retracting the working shaft 118 of the third catheter 110 relative to the outer shaft 122 and / or advancing the outer shaft 122 relative to the working shaft 118, thereby bending the anchor 134 into the configuration shown in Figure 12. At any point during the procedure, the physician can lock the relative positions of the actuation shaft 118 and the outer shaft 122, and therefore the position of the anchor 134, by activating an actuation locking mechanism (not shown) on the handle 124 of the delivery device 104.

[0130] Next, the artificial spacer device 102 can be positioned coaxially with respect to the natural mitral valve 300 by manipulating (e.g., steering and / or bending) the second sheath 116 of the second catheter 108. The artificial spacer device 102 can also be rotated relative to the natural mitral valve 300 so that the anchor 134 aligns with the natural valve leaflets 308 of the natural mitral valve 300.

[0131] Next, the anchor 134 can be partially opened to the configuration shown in Figure 12 (i.e., moved radially outward relative to the inflatable spacer 132 in its non-inflated state). The artificial spacer device 102 can then be advanced through the annulus of the natural mitral valve 300 and at least partially into the left ventricle 310. The artificial spacer device 102 is then partially retracted so that the anchor 134 is positioned behind the ventricular portion of the natural valve leaflet 308 and the inflatable spacer 132 is positioned on the atrial side of the natural valve leaflet 308.

[0132] During the implantation procedure, the inflatable spacer 132 can be initially inflated from its non-inflated configuration at various points in time. For example, in some situations, the inflatable spacer 132 can be inflated after the artificial spacer device 102 has been exposed from the second sheath 116 and before the anchors 134 of the artificial spacer device 102 are connected to the natural valve leaflets 308 and / or before the inflatable spacer 132 is positioned between the natural valve leaflets 308. In other situations, the inflatable spacer 132 can be inflated after the artificial spacer device 102 has been exposed from the second sheath 116 and after the anchors 134 of the artificial spacer device 102 have been connected to the natural valve leaflets 308 and / or after the inflatable spacer 132 has been positioned between the natural valve leaflets 308.

[0133] Referring next to Figure 13, the natural valve leaflets 308 can be fixed to the anchor 134 by capturing them with the clasp 136. The natural valve leaflets 308 can be captured simultaneously or separately. For example, Figure 13 shows separate leaflet capture. Further details regarding the implantation of the artificial spacer device can be found, for example, in Patent Document 3.

[0134] Once clasp 136 is closed, the physician can reopen it to adjust the position of the clasp. When the clasp is reopened, clasp 136 moves radially inward toward the inflatable spacer 132 until it contacts the inflatable spacer 132. With both natural valve leaflets 308 fixed within clasp 136, anchor 134 (and therefore natural valve leaflets 308) can be pulled radially inward toward the inflatable spacer 132 as shown in Figure 14. The inflatable spacer 132 can then be inflated. The physician can then observe the positioning and / or reduction of regurgitation.

[0135] The internal and / or external surfaces of the artificial spacer device 102 may have additional features. For example, a portion of the artificial spacer device 102, such as the central portion, may accommodate or support a radiopaque (fluorescent) marker or a reflective marker, which can be used to assist in locating and positioning the artificial spacer device 102 during implantation. If the inflatable spacer 132 is inflated asymmetrically, the marker may be used to ensure that the inflatable spacer is positioned in the desired configuration.

[0136] For illustrative purposes, Figures 11 to 14 show an artificial spacer device 102 comprising a single inflatable spacer 132, but the implantation method described herein may have substantially the same steps as in embodiments in which the artificial spacer device 102 comprises multiple inflatable members.

[0137] In embodiments having multiple inflatable members, the physician may inflate or deflate each inflatable member based on the patient's anatomical considerations. In embodiments having multiple inflatable members (e.g., a first inflatable member 200a and a second inflatable member 200b), the physician may begin by partially or completely inflating one of the inflatable members (e.g., the first inflatable member 200a). The physician may then monitor the patient's mitral valve regurgitation. If further sealing of the mitral valve is required, the physician may further inflate the first inflatable member 200a and / or the second inflatable member 200b (e.g., as shown in Figure 16) so that both members are at least partially inflated.

[0138] If the positioning and / or regurgitation reduction of the artificial spacer device is not desired, the physician may adjust the position of the artificial spacer device 102 within the mitral valve by reopening the anchor 134 and / or clasp 136, releasing the natural valve leaflet 308, and removing and / or repositioning the artificial spacer device 102. Furthermore, the physician may adjust the level of mitral valve regurgitation and / or other considerations by inflating / deflating the inflatable member.

[0139] The physician can then re-evaluate the positioning and / or function of the artificial spacer device and make additional adjustments as desired. The artificial spacer device can be adjusted to various configurations. For example, Figure 15 shows one embodiment of the artificial spacer device 102 having two inflatable members 200 implanted in a symmetrical configuration with both the first inflatable member 200a and the second inflatable member 200b in a non-inflated configuration. Figure 16 shows the same embodiment in a symmetrical configuration with both the first inflatable member 200a and the second inflatable member 200b in a fully inflated configuration, and Figure 17 shows the same embodiment in an asymmetrical configuration with the first inflatable member 200a in an inflated configuration and the second inflatable member 200b in a non-inflated configuration. With respect to these inflatable spacers, any combination of non-inflated, partially inflated, and / or fully inflated configurations is available.

[0140] In embodiments in which the artificial spacer device 102 is removably coupled to the delivery device using a coupler 120 (see, for example, Figures 7-8), when the actuarial shaft 118 is retracted proximal, the stabilizer member 162 is withdrawn from the guide opening in the second collar, thereby allowing the artificial spacer device 102 to be removed from the delivery device 104. The clasp control member 126 and the expansion shaft can then be retracted proximal into the lumens 156, 158 of the outer shaft 122, and the outer shaft, together with the actuarial shaft 118, can be retracted proximal through the first and second catheters and removed from the patient's body.

[0141] In embodiments in which the artificial spacer device is coupled to a delivery device using multiple tethers 164, the delivery device may be implanted in a manner similar to that described above and as shown in Figures 11 to 15. However, once positioned, the physician can slacken the tethers 164, the clasp control members 126, and the inflation shaft so that the outer shaft 122 can be separated from the proximal end portion of the artificial spacer device 102. In this way, the artificial spacer device can be partially removed from the delivery device 104, but the tethers 164, the clasp control members 126, and the inflation shaft remain coupled to the artificial spacer device 102. The flexibility and slack of the tethers, clasp control members, and inflation shaft allow the artificial spacer device to move and / or function as if it were completely removed from the delivery device. As a result, for example, a partial removal configuration may allow physicians to better evaluate the function and / or positioning of the artificial spacer device 102 before complete removal of the device, to reposition and / or remove the device, or to deflate / inflate the inflatable spacer 132 as needed for functional improvement. This is because the outer shaft 122 and / or actuating shaft 118 have relatively higher rigidity than the clasp control member 126, tether 164, and inflation shaft, and therefore allow for changes in the position and / or hemodynamic action of the artificial spacer device 102 compared to when the artificial spacer device 102 is partially or completely removed from the delivery device 104.

[0142] If the physician wishes to adjust the positioning of the artificial spacer device 102, the tether 164 can be tightened, and the distal end portion 122b of the outer shaft 122 can be advanced distally on the tether 164 so as to abut against the proximal end portion of the artificial spacer device. The actuarial shaft 118 can be advanced distally through the central lumen of the outer shaft 122 and reconnected to the first collar 138. The artificial spacer device 102 can then be moved relative to the natural valve leaflet by acting on the actuarial shaft 118 and / or the clasp control member 126 to operate the anchor 134 and / or the clasp 136, respectively. The artificial spacer device can then be moved relative to the natural valve leaflet by acting on the actuarial shaft 118 and / or the clasp 136, respectively. The physician can then re-evaluate the positioning and / or function of the artificial spacer device and make further adjustments as desired.

[0143] Once the desired positioning and / or backflow reduction is achieved, the physician may remove the artificial spacer device 102 from the delivery device 104. The clasp 136 may be removed from the delivery device 104 by removing the clasp control member 126 and releasing the clasp control member 126 from the opening of the clasp. The first collar 138 of the artificial spacer device 102 may be removed from the delivery device 104 by rotating the knob 128 in a second direction (e.g., counterclockwise) to retract the actuarial shaft 118 proximal to the first collar 138. The actuarial shaft 118 may then be retracted proximal to the artificial spacer device 102. The second collar 140 of the artificial spacer device may then be removed from the delivery device by retracting the actuarial shaft 118 proximal to the second collar 140.

[0144] Next, the clasp control member, expansion shaft, and tether can be retracted proximal to the lumens 156, 158, and 166 of the outer shaft 122, and the outer shaft, together with the working shaft 118, can be retracted proximal to the first and second catheters and removed from the patient's body.

[0145] In some embodiments, when an artificial spacer device is implanted at the A2 / P2 position and the delivery device is removed, the natural mitral valve is able to have a double orifice during ventricular diastole. During ventricular systole, the natural valve leaflets 308 can join together and / or to the artificial spacer device to prevent or reduce mitral regurgitation (see, for example, Figures 15-17). As shown in Figures 15-17, various expansion configurations of the artificial spacer device form various surfaces that the natural valve leaflets 308 can come into contact with for joining.

[0146] In some embodiments, the anchor may move radially outward relative to the expandable spacer to a partially open configuration during ventricular diastole, so that the natural mitral valve has a single continuous orifice. By configuring the artificial spacer device in this way, the natural valve leaflets 308 can move naturally. For example, this can promote forward blood flow during ventricular diastole while still reducing or preventing backward blood flow during ventricular systole. It can also reduce or prevent natural tissue damage to the natural valve leaflets 308.

[0147] In other embodiments, any of the artificial spacer devices disclosed herein may comprise an inflatable spacer (having one or more inflatable members) and a frame configured to be mounted on only one natural valve leaflet, such as one of the natural mitral valve leaflets. In such embodiments, the frame may comprise one anchor and optionally one clasp mounted on one natural valve leaflet. Once mounted, the artificial spacer device may move with the thus mounted natural valve leaflet during the cardiac cycle, while another natural valve leaflet may be joined to the artificial spacer device. Furthermore, the artificial spacer device does not need to be directly implanted on one or more natural valve leaflets, but may instead comprise any suitable anchor configured to hold the inflatable spacer between the natural valve leaflets of the heart valve. For example, the anchor may comprise a structure configured to engage with a portion of the heart wall, such as a portion of the left ventricular wall, or with a portion of the annulus of a natural heart valve. For example, the artificial spacer device may comprise an inflatable spacer mounted on an anchor in the form of a shaft configured to engage with the heart wall. In one particular implementation, the inflatable spacer is mounted on the upper end of a shaft, and the lower end of the shaft is configured to be anchored to the left ventricular wall, such as at the apex of the heart. In another example, the inflatable spacer may have a barb or other means of fastening for attachment to the surface of the natural valve leaflet. In yet another example, a frame is configured to engage with the inner wall of the left atrium and support the inflatable spacer in the natural mitral valve downstream of the frame. Further details regarding anchors for anchoring to various parts of the heart and which may be implanted within the artificial spacer device are disclosed in Patent Documents 5 and 6. In all such examples, the inflatable spacer and / or inflatable member can be inflated and / or deflated in the manner described above.

[0148] The repair devices described herein (e.g., artificial spacer device 102) have been described in connection with the repair of the natural mitral valve. However, it should be understood that these repair devices can also be used to repair other natural heart valves or artificial heart valves or artificial heart valve components (e.g., artificial leaflets), including the use of various transcatheter techniques (e.g., transatrial, transventricular, etc.). For example, the artificial spacer device 102 may be used to reduce or improve valve regurgitation by improving the connection between heart valve leaflets. In the case of artificial heart leaflets, after implantation of such leaflets, the leaflets may change over time in terms of mechanical or structural properties (e.g., loosening), or the shape of the heart or its components may change, thereby preventing the heart valve leaflets (e.g., artificial leaflets and one or more natural leaflets, or optionally multiple artificial leaflets with natural leaflets) from connecting to the desired degree. The repair devices of this disclosure may be implanted to reposition an artificial leaflet to improve its connection with one or more other leaflets.

[0149] While transseptal delivery techniques have been described in detail above, any of the various other delivery techniques may be used for the delivery of positioning devices via the patient's blood vessels. In transfemoral procedures, the delivery device may be inserted retrogradely into the heart via the femoral and aortic arteries. Alternatively, the delivery device may be inserted antegradely into the right side of the heart via the femoral and vena cava veins, for example, to implant the positioning device on one of the leaflets of the tricuspid valve. In transventricular procedures, the delivery device may be inserted through surgical incisions formed in the chest and at some location above the left or right ventricle to access the valves on the left and right sides of the heart. For example, the delivery device may be inserted through an incision formed in an exposed portion on the lower anterior ventricular wall to access the left ventricle. Similarly, the delivery device may be inserted through a surgical incision on the right ventricular wall to access the pulmonary or tricuspid valve. In transatrial procedures, the delivery device may be inserted through surgical incisions formed in the wall of the left or right atrium to access the respective natural valve leaflets on the left or right side of the heart. In transaortic procedures, the delivery device can be inserted through a surgical incision made in the ascending aorta and advanced toward the heart. Further details of delivery techniques for accessing the natural valves of the heart are disclosed in Patent Document 7.

[0150] Figures 18-19 show an exemplary artificial spacer device 400. The artificial spacer device 400 is substantially the same as that of Embodiment 102, except for the non-inflatable configuration. The artificial spacer device 400 comprises a frame 402, an anchor 404, and an inflatable spacer 406 having a plurality of inflatable members 408 (for example, two, 408a and 408b, in the illustrated embodiment).

[0151] As shown in the illustrated embodiment, the expandable members 408a and 408b have respective lengths L a , L b , width W a , W b , and height H a H bIt may have. The expandable members 408a and 408b are configured such that when the expandable members are moved between the expanded configuration and the non-expanded configuration, one or more of the length dimension, width dimension, and / or height dimension of these expandable members are fixed so that the expandable members do not change (at least do not substantially change) in these predetermined dimensions.

[0152] The expandable members 408a and 408b can be configured such that one or more of the length dimension, width dimension, and / or height dimension of these expandable members are variable so that the expandable members change when the expandable members are moved between the expanded configuration and the non-expanded configuration. For example, in the embodiments of FIGS. 18 to 19, the expandable members 408a and 408b are configured such that when the expandable members are moved between the expanded configuration (e.g., expandable member 408a) and the non-expanded configuration (e.g., expandable member 408b), the length dimension and height dimension of the expandable members do not change, and the width dimension changes. In some embodiments, the predetermined fixed dimensions of both expandable members can be the same dimension (e.g., L a and L b ) and / or the same size (e.g., L a =L b ). In other embodiments, the predetermined fixed dimensions of the expandable spacers can be different dimensions (e.g., L a and W a ) and / or different sizes (e.g., L a ≠L b ).

[0153] The inflatable members 408a and 408b can be partially inflated, fully inflated, and / or deflated independently of each other. In some embodiments, each inflatable member 200 can be independently deflated and / or partially or fully inflated to form various symmetrical or asymmetrical configurations. Figures 18-19 show an exemplary asymmetrical configuration achieved by inflating the first inflatable member 408a into an inflated configuration and maintaining the second inflatable member 408b in a non-inflated configuration. In this illustrated embodiment, the width W is achieved by inflating the inflatable members 408a and 408b. a This increases the amount of space located between the opposing valve leaflets of the backflow valve, and also increases the height H a and length L a To keep it constant or substantially constant during expansion.

[0154] In other respects (e.g., expansion and / or contraction, implantation, and repositioning), the artificial spacer device 400 may be configured to function substantially similarly to the artificial spacer device 102.

[0155] Unless otherwise indicated, any feature described in relation to any example herein may be combined with any other feature described in one or more of the other examples.

[0156] In view of the numerous possible embodiments to which the principles of the invention of this disclosure may be applied, it should be understood that the illustrated embodiments are merely preferred examples of the invention and should not be construed as limiting the scope of the claims. Rather, the scope of the claimed subject matter is defined by the appended claims and their equivalents. [Additional note 1] An implantable artificial device, An expandable spacer having an internal cavity, wherein the expandable spacer is expandable between a non-expandable configuration and an expandable configuration, and in the expandable configuration, the expandable spacer is configured to be positioned between natural heart valve leaflets to reduce regurgitation between the natural heart valve leaflets, A frame comprising at least one anchor configured to be positioned on one side of one of the natural heart valve leaflets, and a clasp coupled to the anchor and configured to be positioned on the other side of the one natural heart valve leaflet, wherein the clasp is movable between an open position and a closed position, Equipped with, The clasp is configured to hold a portion of the one natural heart valve leaflet relative to the anchor when in the closed position. An implantable artificial device wherein the expandable spacer is configured to expand from a non-expandable configuration to an expandable configuration by filling the internal cavity of the expandable spacer with an expansion medium. [Additional note 2] The implantable artificial device according to Appendix 1, further comprising a source of the expansion medium, wherein the expansion medium comprises physiological saline. [Additional note 3] The implantable artificial device according to Appendix 1, wherein the expandable spacer is configured to expand from the non-expandable configuration to the expandable configuration upon receiving blood. [Additional note 4] The inflatable spacer comprises an expansion valve, as described in any one of the appendices 1 to 3, for the implantable artificial device. [Additional note 5] The aforementioned expansion valve is a check valve, as described in Appendix 4, for the implantable artificial device. [Additional note 6] The internal cavity contains a matrix material, as described in any one of the appendices 1 to 5, for implantable artificial devices. [Additional note 7] An implantable artificial device according to any one of the appendices 1 to 6, further comprising an expandable cover that covers the outer surface of the expandable spacer. [Additional note 8] The implantable artificial device according to Appendix 7, wherein the stretchable cover comprises a material configured to promote internal tissue growth. [Additional note 9] The implantable artificial device according to any one of the appendices 1 to 8, wherein the inflatable spacer has a longitudinal axis extending from the upstream end to the downstream end of the inflatable spacer, and the inflatable spacer is configured to form an asymmetric shape with respect to the longitudinal axis when at least partially inflated. [Additional Note 10] An implantable artificial device, An inflatable spacer, positioned between natural heart valve leaflets and configured to reduce regurgitation between the natural heart valve leaflets, wherein the inflatable spacer comprises a plurality of inflatable members, each having an internal cavity, and each inflatable member is expandable between a non-inflatable configuration and an inflatable configuration. At least one anchor configured to anchor and fix the inflatable spacer to the natural heart valve leaflet, wherein each inflatable member can be independently inflated to its respective expansion configuration, An implantable artificial device equipped with the following features. [Additional Note 11] The implantable artificial device according to appendix 10, wherein the expandable spacer can form an asymmetric shape when the expandable members are each expanded with different amounts of expansion medium. [Additional Note 12] The implantable artificial device according to appendix 10 or 11, wherein the plurality of inflatable members comprises a first inflatable member and a second inflatable member that are located on both sides in the diametrical direction of the central longitudinal axis of the inflatable spacer and extend radially outward from the central longitudinal axis. [Additional Note 13] The implantable artificial device according to Appendix 12, wherein each inflatable member comprises a first main surface and a second main surface located on the opposite side, configured to join with the natural heart valve leaflets when the inflatable spacer is implanted between the natural heart valve leaflets, and each inflatable member has a width measured from the first main surface to the second main surface, and each inflatable member is configured to increase in width when inflated. [Additional Note 14] The implantable artificial device according to any one of appendices 10 to 13, wherein the inflatable spacer comprises a first medium passage and a second medium passage, the first medium passage being adapted to receive a pressurized inflatable medium and to allow the inflatable medium to flow into the first inflatable member, and the second medium passage being adapted to receive the pressurized inflatable medium and to allow the inflatable medium to flow into the second inflatable member. [Additional Note 15] The implantable artificial device according to any one of the appendices 10 to 14, comprising at least two anchors configured to be anchored to the natural heart valve leaflets. [Additional Note 16] An implantable artificial device according to any one of appendices 10 to 15, further comprising an elastic cover that covers the outer surface of the inflatable spacer. [Additional Note 17] The implantable artificial device according to Appendix 16, wherein the expandable spacer is inelastic, and the elastic cover stretches in at least one direction when one of the expandable members expands. [Additional Note 18] The implantable artificial device according to any one of appendices 10 to 17, wherein the plurality of inflatable members comprises a first inflatable member and a second inflatable member, the first inflatable member and the second inflatable member being of different sizes and / or shapes when fully inflated. [Explanation of Symbols]

[0157] 100 Delivery Assembly 102 Artificial Spacer Devices 104 Delivery device 106 First catheter 108 Second catheter 110 Third catheter 112 Catheter stabilizer 114 The First Sheath 116 The Second Sheath 118 Inner shaft, operating shaft 118a Proximal end portion 118b Distal end portion 120 Coupler 122 Outer shaft 122a Proximal end portion 122b Distal end section 124 Handle 126 Clasp control member 128 Operating knob 130 frames 132 Expandable Spacer 132a First end portion, first end 132b Second end portion, second end 132c middle part 133 Material layer 134 Anchors 134a First part, first end part 134b Second part, second end part 134c Joint section 136 Clasp 136a Mounting part 136b Arm section 138 First Color 140 Second Color 141 Aperture 142 Anchor extension member 142a Fixed end part 142b Free end section 143 tabs 144 The third color 146 Internal chamber, internal cavity 147 Side opening 151 Expansion valve 151a First expansion valve 151b Second expansion valve 152 Cover 153a Media path 153b Media path 154 Lumens of operating shaft 156 control element lumens 158 expansion shaft lumens 160 Flexible Arm 162 Stabilizer, stabilizer component 164 Tether 166 tether lumens 200 Expandable member 200a First expandable member 200b Second expandable member 202 Main surface 206 Shaft, Sleeve 210 Outer edge 300 Natural Mitral Valve 302 Heart 304 Atrial septum 306 Left atrium 308 Natural valve apex 310 Left ventricle 400 Artificial Spacer Devices 402 frames 404 Anchor 406 Expandable Spacer 408 Expandable member 408a First expandable member 408b Second expandable member

Claims

1. An implantable artificial device, A spacer positioned between the leaflets of a natural heart valve to reduce regurgitation between the leaflets and to form a double opening in the natural heart valve during ventricular diastole, A spacer that is expandable between a non-expandable configuration and an expandable configuration, At least one anchor configured to anchor the spacer to at least one of the natural heart valve leaflets, An elastic cover that covers the outer surface of the spacer, The elastic cover is configured such that the spacer can prevent and / or reduce blood flow through the spacer. The elastic cover stretches in at least one direction when the spacer expands, A clasp that is movable between the open and closed positions, Equipped with, The clasp is configured to hold the at least one portion of the natural heart valve leaflet with respect to the anchor when in the closed position. The spacer is configured to be adjusted between the non-expanded configuration and the expanded configuration within the patient's body during the implantation procedure to accommodate the anatomical variability of a particular patient. Implantable artificial devices.

2. The implantable artificial device according to claim 1, wherein the shape of the spacer is one of elliptical, egg-shaped, cylindrical, and rectangular.

3. The implantable artificial device according to claim 1, wherein the dimensions of the spacer can be adjusted from 5 mm to 15 mm.

4. The implantable artificial device according to claim 3, wherein the dimension is the width of the spacer.

5. An implantable artificial device, An adjustable spacer having an internal cavity, The adjustable spacer is adjustable between an extended configuration and a non-extended configuration. The adjustable spacer is positioned between the natural heart valve leaflets to reduce regurgitation between the natural heart valve leaflets and to form a double opening in the natural heart valve during ventricular diastole. The spacer includes a cover configured such that the spacer can reduce blood flow through the spacer. The cover extends in at least one direction when the spacer is expanded, and the spacer and At least two anchors, each configured to fix a leaflet of the natural heart valve to the spacer, A clasp that is movable between an open position and a closed position, The clasp is configured to hold a portion of the natural heart valve leaflet to at least one of the at least two anchors when the clasp is in the closed position, Equipped with, An implantable artificial device in which the adjustable spacer is configured to adjust from the non-expanded configuration to the expanded configuration by pushing the internal cavity outward.

6. The implantable artificial device according to claim 5, wherein the shape of the spacer is one of elliptical, egg-shaped, cylindrical, and rectangular.

7. The implantable artificial device according to claim 5, wherein the width of the spacer can be adjusted from 5 mm to 15 mm.

8. The implantable artificial device according to claim 7, wherein the width of the spacer can be adjusted to 5 mm, 7.5 mm, and 10 mm.

9. The implantable artificial device according to claim 5, wherein the diameter of the spacer can be adjusted from 5 mm to 15 mm.

10. The implantable artificial device according to claim 5, wherein the spacer is configured to change shape in its original location.

11. An implantable artificial device, A spacer positioned between natural heart valve leaflets and configured to reduce regurgitation between the natural heart valve leaflets, The spacer comprises a plurality of members, each having an internal cavity, Each component is expandable between a non-expandable configuration and an expandable configuration, with spacers, At least one anchor configured to anchor the spacer to the natural heart valve leaflet, Each component can be independently extended to its respective extension configuration, including an anchor, An elastic cover that covers the outer surface of the spacer, An elastic cover that stretches in at least one direction when one of the plurality of members is expanded, An implantable artificial device equipped with the following features.

12. The implantable artificial device according to claim 11, wherein the shape of the spacer is one of elliptical, egg-shaped, cylindrical, and rectangular.

13. The implantable artificial device according to claim 12, wherein the width of the spacer can be adjusted from 5 mm to 15 mm.

14. The implantable artificial device according to claim 13, wherein the width of the spacer can be adjusted to 5 mm, 7.5 mm, and 10 mm.

15. The implantable artificial device according to claim 11, wherein the diameter of the spacer can be adjusted from 5 mm to 15 mm.

16. The implantable artificial device according to claim 11, wherein the spacer is configured to change shape in its original location.

Images