Systems and methods for delivering annuloplasty devices

Abstract

The present invention relates to a system for delivering an annuloplasty device for restoring a heart valve annulus from a dysfunctional configuration to a working configuration wherein the annuloplasty device is configured to expand from a preset configuration corresponding to the working configuration of the valve annulus, the system comprising a delivery device, a delivery device is configured to be removably coupled to an annuloplasty device, where the delivery device includes a structure configured to expand from a first configuration to a second configuration, where the second configuration is substantially equal to or greater than a predetermined configuration of the annuloplasty device.

Description

Technical Field

[0001] The present invention relates to systems and methods for delivering medical devices such as implants. More particularly, the present invention relates to systems and methods for delivering annuloplasty devices. Background Art

[0002] Annuloplasty is a procedure that repairs a heart valve by tightening or strengthening the annulus surrounding the valve. Annuloplasty surgery is often used to treat heart valve regurgitation. For example, the mitral valve regulates blood flow from the left atrium to the left ventricle and prevents blood from flowing back from the left ventricle into the left atrium. Mitral regurgitation is a condition that occurs when blood flows backward into the left atrium through a so-called "leaky heart valve." This backflow is caused by a malfunctioning heart valve, which may be malfunctioning due to injury, malformation, and / or disease.

[0003] If the condition is mild, little or no treatment is needed. However, in some cases, the backflow of blood puts stress on the heart and causes it to work harder to make up for the amount that is leaking. A common and effective surgical method for treating this condition is the use of an annuloplasty band or ring, which reduces the size of the annulus surrounding the leaking valve to restore normal working function.

[0004] In recent years, alternative surgeries - particularly using transcatheter techniques - have been developed to treat patients who are not suitable for surgical intervention. Transcatheter or percutaneous procedures are minimally invasive and therefore cause little trauma.

[0005] A major challenge of transcatheter surgery is accessibility, including the delivery of medical tools and devices to the target site and their precise and safe manipulation at the target site. Despite great progress in this field, it is still difficult to implant microdevices in areas hindered by the patient's anatomy. In addition, for successful implantation, medical practitioners must consider the specific anatomical landscape of the target area (such as shape, size, damage and condition).

[0006] While appropriately shaped and sized annuloplasty devices can be manipulated, positioned, and attached directly to the dysfunctional annulus during surgery, transcatheter implantation requires imaging equipment to visualize the device delivery path and target site. Additional complexity is added by accessibility of the target area, lack of direct visualization, and reduced size of transcatheter tools and devices.

[0007] In transcatheter surgery, the annuloplasty device (and the medical tools it operates) is delivered via a catheter, which is routinely advanced through the patient's circulatory system. Therefore, due to size limitations, it is difficult, if not impossible, to deliver an annuloplasty device with a fixed configuration. The fixed configuration would be the configuration of the device required to return the annulus to a working configuration, and the lumen of the delivery catheter would need to be large enough to not only accommodate this final configuration, but also to provide unobstructed space for the surgeon to operate the tools and device. Such a large catheter would not be able to advance through the patient's circulatory system. Thus, transcatheter annuloplasty devices are retractable or collapsible so as to be delivered via a catheter.

[0008] Most established transcatheter annuloplasty procedures involve the use of a flexible or semi-flexible band or ring. Once in the target area, the surgeon positions the band or ring, sutures, screws, or otherwise anchors it to the degenerated annulus to form the desired final working configuration, and then tightens it to narrow the annulus.

[0009] Therefore, there is a requirement for transcatheter annuloplasty devices to be collapsible in order to be delivered via a catheter, and a consequence of this requirement is that the surgeon must recreate the working configuration of the annuloplasty device in situ.

[0010] The anatomy of heart valves is inherently complex, and so is repairing them with currently available technology. Developing new annuloplasty devices and corresponding delivery tools is costly, and medical practitioners require extensive and intensive training for each device type before they can be fitted to a patient. Therefore, the process of establishing each new device in current medical practice is highly resource-intensive.

[0011] Furthermore, even with sophisticated devices and tools, intensive training, and expert surgical intervention, there are so many variables at play that the outcome of the procedure is unpredictable. Until the band is tightened, it is difficult to predict whether the band has been properly positioned and anchored so that regurgitation can be significantly minimized. At this stage, the device has been sutured to the annulus and can only be retrieved surgically, if at all. It is also difficult to predict whether the restoration of the valve will be permanent. Furthermore, repeated attempts at successful implantation, as well as trial and error, can cause damage and trauma to the patient's anatomy. Despite all efforts, the band may still fail to successfully restore the valve.

[0012] It is an object of the present invention to alleviate problems such as those discussed above and to provide an improved alternative to existing products.

[0013] In particular, there is a need for a simpler, more standardized, less resource-intensive, and less invasive system and method for repairing leaking heart valves.

[0014] There is also a need for a system and method for easy handling, efficient delivery, and accurate positioning of annuloplasty devices. There is also a need for a system and method that can reposition annuloplasty devices wherever they are needed. Summary of the invention

[0015] According to a first aspect of the invention, a system for delivering an annuloplasty device for restoring a heart valve annulus from a dysfunctional configuration to a working configuration is provided. The annuloplasty device is configured to expand from a preset configuration corresponding to a working configuration of the valve annulus. The system includes a delivery device configured to be removably coupled to the annuloplasty device. The delivery device includes a structure configured to expand from a first configuration to a second configuration, wherein the dimensions of the second configuration are substantially the same as or greater than the dimensions of the preset configuration of the annuloplasty device.

[0016] The delivery system is constructed and arranged to expand so that the annuloplasty device can be positioned on and around the annulus adjacent to the associated anchoring locations. Once the annuloplasty device is properly positioned, it can be released to revert to its preset configuration, which restores the annulus to its working configuration. The annuloplasty device can also be constructed and arranged to be folded to fit into a delivery sheath. The system according to the present invention has been specifically developed and adapted for delivering such annuloplasty devices. In particular, the delivery system is constructed and arranged to grasp the annuloplasty device, expand it beyond its preset configuration for positioning, release it, and thereby allow the annuloplasty device to revert to its preset configuration and anchor to the annulus.

[0017] The expandable structure of the delivery device may include a shaft and one or more arms. The arm(s) may be movably connected to the shaft. The arm(s) may, for example, be pivotally connected to the shaft. The arm(s) may have a proximal end and a distal end, and the proximal end may be connected to the shaft. Preferably, the proximal end of the arm is fixedly connected to the shaft (i.e., at a connection point on the shaft) so that the arm can move or pivot about the connection between the proximal end of the arm and the shaft.

[0018] The arms can be configured to fold radially inwardly into a first configuration. In other words, the arms can be folded inwardly toward the shaft (e.g., radially inwardly relative to the longitudinal axis of the shaft), i.e., the distance between the distal ends of the arms and the shaft is reduced. The first configuration can be referred to as a "folded configuration," which allows the delivery system to fit within a delivery sheath, e.g., for delivery, release, and / or re-retrieval of the delivery system.

[0019] The arms can be configured to expand radially outward into a second configuration. In other words, the arms can expand away from the shaft (e.g., radially outward relative to the longitudinal axis of the shaft), i.e., the distance between the distal ends of the arms and the shaft increases. The second configuration can be referred to as an "expanded configuration," which allows the delivery system to expand beyond its preset configuration. Thus, the annuloplasty device can be manipulated, positioned, and / or repositioned prior to release.

[0020] The delivery system may include an actuator for controlling the expansion of the expandable structure. The actuator allows adjustment and control of the degree of expansion of the expandable structure. Where the expandable structure includes multiple arms, the actuator may control the expansion of individual arms and / or one or more groups of arms, or control the expansion of all arms simultaneously. The actuator may be constructed and arranged such that the distal expansion of the arms (at the patient end) is controlled from the proximal side (user side) of the delivery system.

[0021] The actuator may include an actuator rod. The rod may slide relative to the longitudinal axis of the shaft. The actuator may include one or more tensioners.

[0022] The stretcher may be coupled to the arm and the actuating rod. The stretcher(s) may be movably coupled to the arm(s) and / or the actuating rod. For example, the stretcher(s) may be pivotally coupled to the arm(s) and / or the actuating rod.

[0023] The stretcher may have a proximal end and a distal end. The distal end of the stretcher may be coupled to an actuating rod, and the proximal end of the stretcher may be coupled to an arm (or arms). Preferably, the proximal end of the arm is fixedly connected to the arm (or arms) and / or the actuating rod (i.e., at one connection point) so that the stretcher may move or pivot about the connection between the proximal and distal ends of the stretcher and the arm (or arms) or the actuating rod, respectively.

[0024] The actuation rod may have a proximal end and a distal end. The tensioner may be coupled to the distal end of the actuation rod or adjacent to the distal end of the actuation rod.

[0025] Each arm includes a proximal end, a distal end, and a middle portion extending therebetween. In some embodiments, the stretcher is coupled to the middle portion of the arm. In some embodiments, the stretcher is coupled to the proximal end of the adjacent arm.

[0026] The stretcher may extend between the actuation rod and one arm, thereby allowing individual expansion or collapse of the arms. The stretcher may extend between the actuation rod and two or more arms, thereby allowing simultaneous expansion or collapse of the two or more arms.

[0027] In some embodiments, the shaft includes one or more lumens. The actuating rod can be housed in a lumen of the shaft. The actuating rod can be constructed and arranged to slide within the lumen of the shaft. The actuating rod can be constructed and arranged to slide beyond the distal end of the shaft, thereby radially expanding the arm.

[0028] In some embodiments, the actuator may include an actuation sleeve. The actuation sleeve may be slidable relative to the longitudinal axis of the shaft. The actuator may include one or more tensioners coupled to the arm and the actuation sleeve.

[0029] The stretcher(s) may be movably coupled to the arm(s) and / or the actuating sleeve. For example, the stretcher(s) may be pivotally coupled to the arm(s) and / or the actuating sleeve.

[0030] The stretcher has a proximal end and a distal end. The proximal end of the stretcher can be coupled to an actuating sleeve, and the distal end of the stretcher can be coupled to (one or more) arms. Preferably, the proximal end of the arm is fixedly connected to (one or more) arms and / or the actuating sleeve (i.e., at one connection point) so that the stretcher can move or pivot around the connection between the distal end or proximal end of the stretcher and (one or more) arms or the actuating sleeve, respectively.

[0031] The actuation sleeve may have a proximal end and a distal end. The tensioner may be coupled to the distal end of the actuation sleeve or adjacent to the distal end of the actuation sleeve.

[0032] Each arm includes a proximal end, a distal end, and a middle portion extending therebetween. In some embodiments, the stretcher is coupled to the middle portion of the arm. In some embodiments, the stretcher is coupled adjacent to the proximal end of the arm.

[0033] The stretcher may extend between the actuation sleeve and one arm, thereby allowing individual expansion or collapse of the arms. The stretcher may extend between the actuation sleeve and two or more arms, thereby allowing simultaneous expansion or collapse of the two or more arms.

[0034] The actuation sleeve may include one or more lumens. The shaft may be received in a lumen of the actuation sleeve.

[0035] The shaft may be constructed and arranged to slide within the lumen of the actuation sleeve.The shaft may be constructed and arranged to slide beyond the distal end of the actuation sleeve, thereby radially expanding the arms.

[0036] The delivery device may include one or more connectors for removably coupling the expandable structure to the annuloplasty device. The connector may include a removable ring connector or a hook connector.

[0037] The ring may include one or more severable segments. The ring may surround a portion of the annuloplasty device, thereby securing the annuloplasty device. The ring may be severed (e.g., by breaking, rupturing, dissolving, or by other suitable means) to release the annuloplasty device.

[0038] The hook connector can be made of a shape memory material so that in its preset configuration, the connector forms a hook. In its preset configuration, the hook can partially surround a portion of the annuloplasty device to secure the annuloplasty device. The hook can be deformed to release the annuloplasty device.

[0039] In some embodiments, the connector may include one or more ribs constructed and arranged to receive a connector control line.The rib may include a distal end coupled to or adjacent to the distal end of the arm.

[0040] In some embodiments, one or more arms are constructed and arranged to receive a connector control line.

[0041] The rib and / or arm may include a connector outlet. The connector outlet may be located at the distal end of the rib and / or arm to allow the loop connector or hook connector to extend beyond the distal end of the rib and / or arm. The connector outlet may be pivotally coupled to the rib and / or arm.

[0042] The connector outlet may advantageously be configured to protect surrounding tissue of the patient from damage by providing an atraumatic surface.

[0043] The connector outlet can be pivotally, resiliently or otherwise movably coupled to the rib and / or arm relative to the rib and / or arm to provide a surface that aligns with the patient's surrounding anatomy. The surface can be substantially flat or curved, and / or include or consist of a flexible or soft material that will not injure the patient.

[0044] In some embodiments, the delivery system further comprises an annuloplasty device.

[0045] In some embodiments, the delivery device further comprises a positioning device for positioning the annulus in an anchored configuration.

[0046] According to a second aspect of the present invention, a method for restoring a heart valve annulus is provided, comprising the steps of delivering an annuloplasty device for restoring the heart valve annulus from a dysfunctional structure to a working structure, wherein the annuloplasty device is configured to expand from a preset structure corresponding to the working structure of the valve annulus, the system comprising a delivery device configured to be detachably connected to the annuloplasty device using a delivery system according to the present disclosure.

[0047] The method may include the step of coupling the annuloplasty device to an expandable structure of a delivery device.

[0048] The method may include the step of inserting the delivery system into the delivery sheath with the expandable structure in a collapsed configuration.

[0049] The method may include the step of expanding the expandable structure into a second configuration.

[0050] The method may include the step of placing the annulus in an anchoring configuration.

[0051] The method may include the step of releasing the annuloplasty device into its preset configuration.

[0052] In some embodiments, the heart valve is a tricuspid valve and the annulus is an anterior annulus, a posterior annulus and / or a septal annulus.

[0053] It is contemplated that the annuloplasty devices, delivery systems, and other components and corresponding methods described in the present disclosure are used to resize, reconfigure, and / or support any anatomical opening. The anatomical opening may be a natural opening (such as the tricuspid valve, aortic valve, or mitral valve) or an artificial valve.

[0054] In a third aspect of the present disclosure, there is provided a positioning device as described below for positioning a valve annulus in an anchoring configuration. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] The details of one or more embodiments are set forth in the accompanying drawings and the following description. Other features, aspects, and advantages of the present disclosure will become apparent from the description, drawings, and claims, in which:

[0056] Figure 1 is a schematic diagram of an annuloplasty device in its preset configuration (a "band-type" or "ring-type" annuloplasty device);

[0057] Figure 1A Is in extended configuration Figure 1 Schematic diagram of the annuloplasty device;

[0058] Figure 1B It is in a compressed structure Figure 1 Schematic diagram of the annuloplasty device;

[0059] Figure 1C yes Figure 1 Schematic diagram of an annuloplasty device illustrating an anchoring member;

[0060] Figure 2 is a schematic diagram of an annuloplasty device in its preset configuration;

[0061] Figure 2A yes Figure 2 Schematic diagram of an expanded configuration of annuloplasty device;

[0062] Figure 2B yes Figure 1 Schematic diagram of a compressed configuration of an annuloplasty device;

[0063] Figure 2C yes Figure 2 Schematic diagram of an annuloplasty device illustrating an anchoring member;

[0064] Figure 3 is a schematic diagram of an annuloplasty device in its preset configuration;

[0065] Figure 3A yes Figure 3 Schematic diagram of a compressed configuration of an annuloplasty device;

[0066] Figure 4A is a schematic top view of a working mitral valve;

[0067] Figure 4B is a schematic diagram of the three-dimensional shape of a working mitral valve;

[0068] Figure 5 is a schematic top view of a working tricuspid valve;

[0069] FIG. 6A to FIG. 6J is a schematic top view of the shape of annuloplasty device;

[0070] 7A to 7C is a schematic diagram of an annuloplasty device (a "crown-type" annuloplasty device) in its delivery configuration, its expanded configuration, and its preset configuration, respectively;

[0071] Fig. 8A and Figure 8B An annuloplasty device having an inwardly extending anchoring member is shown;

[0072] Fig.9A and Fig. 9B is a schematic diagram of an annuloplasty device (a "bridge" annuloplasty device);

[0073] Fig. 9C is a schematic diagram of an anchoring member for use in an annuloplasty device according to the present invention;

[0074] Fig. 10A , Fig. 10B , Fig. 10C is a schematic diagram of a delivery system according to the present invention;

[0075] Fig.11A , Fig. 11B , Fig. 11C is a schematic diagram of a delivery system according to the present invention;

[0076] Fig. 12A and Fig. 12B is a schematic diagram of a delivery system according to the present invention;

[0077] FIG12 is a schematic diagram of a delivery device coupled to an annuloplasty device;

[0078] Fig.13 is a schematic diagram of a portion of a delivery device 100 coupled to a "crown-type" annuloplasty device 20;

[0079] Fig.14 and Fig.15 are schematic diagrams of an annuloplasty device in its expanded configuration and in its preset configuration, respectively (a "crown-type" annuloplasty device);

[0080] FIG. 16A to FIG. 16E is a schematic diagram of the positioning device; and

[0081] Fig.17 is a schematic diagram of the positioning device during the annulus positioning step.

[0082] The embodiments described herein are provided as exemplary and non-limiting embodiments of the invention. DETAILED DESCRIPTION

[0083] The present disclosure relates to a system for delivering an annuloplasty device for restoring a heart valve annulus from a dysfunctional configuration to a working configuration, wherein the annuloplasty device is configured to expand from a preset configuration corresponding to the working configuration of the valve annulus. The delivery system is interchangeably referred to as an annuloplasty system. The annuloplasty device will be described first, and then the delivery system and method will be described with reference to the annuloplasty device.

[0084] Annuloplasty devices

[0085] The disclosed system is constructed and arranged to deliver an annuloplasty device. The annuloplasty device is constructed and arranged to restore a heart valve annulus from a dysfunctional configuration to a working configuration. The annuloplasty device is constructed and arranged to expand from a preset configuration corresponding to the working configuration of the valve annulus.

[0086] Within the context of the present disclosure, a valve annulus may have a "dysfunctional configuration" in which the valve annulus partially or completely loses its functional activity, which is to provide structural support to the valve so that the valve allows flow from a first compartment to a second compartment and minimizes backflow from the second compartment to the first compartment. A dysfunctional valve annulus may be degenerated (genetically or pathologically), and these terms are used interchangeably herein. For example, the degeneration may result from injury, deformity, or damage, and is often manifested as a loose or dilated valve annulus. In contrast, a "working configuration" is a configuration in which the valve annulus provides sufficient and adequate structural support to minimize or avoid valve regurgitation.

[0087] Exemplary types of annuloplasty devices that may be used with or in the systems and methods of the present invention are described below. A first exemplary annuloplasty device may be interchangeably referred to as a "band-type" or "ring-type" annuloplasty device. A second exemplary annuloplasty device may be referred to as a "crown-type" annuloplasty device. A third exemplary annuloplasty device may be referred to as a "bridge-type" annuloplasty device.

[0088] According to a first example, an annuloplasty device may include a band expandable from a preset configuration, wherein the preset configuration of the band corresponds to a working configuration of the annulus.

[0089] The delivery system can apply a suitable external force to the annuloplasty device to expand from its preset working configuration, thereby enabling it to anchor to the dysfunctional annulus, and when the force ceases, the annuloplasty device automatically contracts or recovers back to its preset working configuration. This contraction mechanism is a key aspect of the annuloplasty device because it helps to simplify and standardize the annuloplasty procedure. This is superior to previous transcatheter annuloplasty systems, which had to be adjusted in situ at the target site in the patient's body by a trained professional surgeon using remotely controlled tools and imaging equipment. In contrast, in the present system, minimal intervention, estimation, and adjustment by the surgeon is required before (e.g., during the grasping and fixation phase) or after releasing the device.

[0090] The preset configuration is the configuration that restores a dysfunctional annulus to a working annulus. Although different patients may differ in size, the overall average three-dimensional shape of the working heart valve annulus of the patients is similar and well known. Therefore, the preset configuration of the annuloplasty device can be converted into a configuration suitable for restoring one or more segments of the dysfunctional annulus and / or restoring the three-dimensional shape of its overall configuration. For the purpose of standardization, the annuloplasty device is preferably manufactured with a preset configuration that corresponds to the average three-dimensional shape of a working human heart valve, but can also be manufactured with modifications to treat specific defects and / or specific patient populations. Annuloplasty devices can be supplied in different sizes.

[0091] Generally speaking, "restoring" the annulus refers to the reduction of one or more dimensions of a pathological (large) annulus. Annuloplasty devices and systems seek to restore the annulus from a dysfunctional or degenerated configuration to a working configuration, and may also be used in the context of preventive and palliative procedures where it is desirable to maintain or preserve one or more dimensions or shapes of the annulus.

[0092] As used herein, "expandable" or "expanded" means that one or more dimensions of the expanded annuloplasty device are larger than one or more corresponding dimensions of the annuloplasty device in a preset configuration. The expanded band has a configuration that allows it to be secured to a degenerated or dilated annulus.

[0093] As used herein, the term "means" may be equivalently expressed as or replaced by any of the following terms: device, instrument, structure, part, sub-part, assembly, subassembly, machine, mechanism, article, medium, material, apparatus, equipment, system, body or similar expressions.

[0094] As used herein, the "proximal" side refers to the side closest to the medical practitioner and the exterior of the patient; the "distal" side refers to the side closest to the target valve annulus.

[0095] The system does not require extensive in situ manipulation and adjustment. Once delivered to the target area, the annuloplasty device is positioned and the band is expanded to reach the attachment site of the dilated annulus. Upon release, the expanded band collapses, contracts, or recovers to its preset configuration, thereby automatically contracting the annulus to its working configuration to prevent large amounts of blood from flowing back through the heart valve.

[0096] The band may be further compressible from a preset configuration. As used herein, "compressible" or "compressed" means that one or more dimensions of the compressed annuloplasty device are smaller than one or more corresponding dimensions of the annuloplasty device in the preset configuration. The band may be deformable, foldable, or collapsible to achieve an expanded configuration and / or a compressed configuration. The compressed band has a configuration such that it can fit within an inner lumen of a delivery catheter or a delivery sheath. The compressed band may be slidably fit within an inner lumen of a delivery catheter or a delivery sheath.

[0097] Compared to surgery, transcatheter procedures are minimally invasive and allow patients to experience less discomfort and recover in a shorter time. However, transcatheter procedures involve smaller devices and instruments, which are more difficult to operate, and further the surgeon's movements are limited by obstructions and obstacles in the patient's own anatomy. Access is not a problem in the case of surgery, and therefore there is little need for additional complex insertion, delivery, viewing and implantation instruments. Annuloplasty devices can be both expandable and compressible, and require minimal manipulation in situ.

[0098] The overall (or some) dimensions of the annulus in the working configuration are the same as or smaller than the annulus in the degenerated configuration. Thus, the annuloplasty device may have a preset configuration with overall (or some) dimensions that are smaller than the dimensions of the expanded device in the deployed configuration; and / or the annuloplasty device may have a preset configuration with overall (or some) dimensions that are larger than the dimensions of the collapsed or compressed annuloplasty device in the delivery configuration.

[0099] The size of the band in the expanded configuration is equal to or greater than the size of the degenerated annulus. Thus, the band can be expanded to reach the attachment site of the annulus and secure the band there.

[0100] The band may be substantially rigid in its preset configuration. The preset configuration of the band is the configuration that supports the annulus in the working configuration. Since the working configuration is the configuration that significantly minimizes regurgitation, there may be more than one working configuration of the annulus.

[0101] The band in its preset configuration may be sufficiently rigid to act as a support, stent or framework for the annulus. When the band is attached to the annulus in its preset configuration, it not only narrows the circumference of the expanded annulus, but also reshapes the annulus. The three-dimensional shape of the annulus will be discussed in further detail below.

[0102] The band in the preset configuration can be substantially saddle-shaped. "Saddle-shaped" includes a band having two or more bends with apexes facing a first direction and two or more bends facing a second direction, the second direction being opposite to the first direction. A saddle-shaped band may include two bends facing upward and two bends facing downward. This preset configuration is particularly beneficial because it defines the anatomical contours of the working annulus. Most advantageously, the annuloplasty device is a substantially elliptical saddle-shaped ring or band.

[0103] Other suitable shapes, contours or portions of the band that allow the annulus to be reshaped into a working configuration are contemplated, including but not limited to elongated members, partial or complete rings, partial or complete ellipses, and the like. Angled shapes, contours or portions may be included, but curved or linear shapes are preferred to avoid tissue trauma and facilitate delivery of the device to the target site.

[0104] The belt may be open or closed. An open belt may be substantially linear, C-shaped, U-shaped, V-shaped, L-shaped, and the like. A closed belt may be substantially circular, oval, rectangular, D-shaped, and the like. Other shapes, such as polygonal, are contemplated. A belt may include one or more segments, and each segment may have the same or different shapes.

[0105] Preferably, the intended overall configuration of the band may be three-dimensional, just like a valve annulus.

[0106] Annuloplasty devices, in particular bands, may include or consist of one or more plastic, rubber or metal materials. The one or more plastic, rubber or metal materials are elastic or have elastic properties. For example, the band may consist of one or more elastic materials, enabling it to expand and / or compress from its preset configuration. Alternatively, the band may include one or more sections consisting of one or more elastic materials.

[0107] Examples of materials include plastics such as silicon-containing materials, rubber, fabrics, metals such as shape memory materials, and alloys (particularly Nitinol).

[0108] The annuloplasty device may include or consist of one or more bioabsorbable materials. Bioabsorbable materials are particularly advantageous because once the annuloplasty device is implanted, fibrous connective tissue will form around the annuloplasty device and will itself serve as a natural support for the annulus. As the bioabsorbable material is slowly absorbed, the newly formed tissue maintains the annulus in its working configuration.

[0109] The annuloplasty device may include a compressible and / or expandable structure. The compression and / or expansion is achieved by a mechanical component.

[0110] The belt may include an expandable and / or compressible mesh or structure. For example, the belt, mesh or structure may have a grid, diamond, serrated, crenellated, sinusoidal, vortex, spiral and / or other pattern. The belt may be integrally formed.

[0111] The strap may include mechanical components, such as hinged connections, elastic connections, springs, pivotable and / or rotatable connections, to achieve expansion and / or compression.

[0112] An annuloplasty device may include a tubular band, ring, or crown comprising or consisting of any one or more of the above-mentioned materials, meshes, or structures.

[0113] The outer surface of the band includes a protective covering, such as a material layer and / or coating. The covering may be provided to enhance contact and interaction with surrounding tissue, thereby promoting fibrosis and tissue growth. The covering may include or consist of a mesh or a woven fabric.

[0114] The covering may comprise or consist of a flexible material that is flexible enough to allow expansion and compression of the band. Examples of materials include polymers such as polyester and polytetrafluoroethylene (PTF).

[0115] The protective covering may include one or more compounds to minimize the risk of thrombosis or inflammation. Examples of compounds include anticoagulants, anti-inflammatory compounds, antibacterial compounds, antiviral compounds, and the like. The protective covering may include one or more healing promoting compounds or compositions, i.e., compounds or compositions that promote healing.

[0116] The band may be anchored in a conventional manner by means of sutures.However, in order to provide a simple and standardized annuloplasty device, method and system, the annuloplasty device preferably comprises means for anchoring the band to the annulus.

[0117] The anchoring member may be a mechanical anchoring member such as a barb, a peg, a hook, a spike and the like. The anchoring member may be connected to, adhered to or glued to the band. It is preferably integrally formed with the band to provide a safer device that is less resource intensive and simpler to manufacture. The use of an integrally formed anchoring member also results in an annuloplasty device that is easier to implant with fewer independently movable elements.

[0118] Bio-glue and bio-adhesives are also contemplated in the context of the present disclosure, and the tape or its covering (where applicable) may be coated with one or more adhesives in lieu of, or preferably in addition to, mechanical anchoring members.

[0119] The annuloplasty device includes means for automatically deploying anchoring members. The anchoring members are automatically deployed and / or secured to the annulus when the band is released from its expanded configuration. The anchoring members may be connected to the band such that the anchoring members are in their anchored configuration in a preset configuration of the band.

[0120] The band may include an anchoring member that is deployed and / or secured to the annulus by rotation of the band about its longitudinal axis (if the band is elongated) and / or by application of pressure (e.g., by pressing the anchoring member into tissue of the annulus).

[0121] According to a second example, the annuloplasty device may include a support structure including a distal ostium. The support structure may be expanded from a preset configuration, wherein the preset configuration of the ostium corresponds to a working configuration of the annulus. The annuloplasty device may also include a member for anchoring the ostium to the annulus.

[0122] In this second example, the band of the first exemplary annuloplasty device is replaced by the stoma of an expandable (and retractable) support structure, and the preset configuration of the stoma of the support structure corresponds to the working configuration of the annulus. In other words, the band and / or stoma are the portion of the annuloplasty device that surrounds and interacts with the annulus to support the annulus in its working configuration.

[0123] The ostium may be defined by an orifice of the annuloplasty device at a distal end or a proximal end thereof, such as by the periphery of the orifice.

[0124] The support structure performs the dual functions of providing structural support to the annuloplasty device and defining the ostium.

[0125] Structural support is advantageous because it allows the ostium to return to and remain in its preset configuration. In other words, it helps retract the ostium to the preset configuration during the implantation process and minimizes or prevents deformation of the ostium once it is implanted on the annulus. The structural support can increase the inward force required to return the ostium to its preset configuration against the outward force exerted by the expanded annulus.

[0126] Structural support can be provided, for example, by the selection of materials, shapes and / or sizes of mechanical members, structural supports. These features can be selected and adjusted to impart the desired support. For example, a material can be selected to provide desired properties, including but not limited to expansion, retraction, resilience, rigidity and flexibility.

[0127] The structural structure includes a mesh structure that may include a diamond pattern. The diamond pattern is a simple structure that allows control and adjustment of the expansion and retraction forces of the device while providing structural rigidity to the device. The shape and size of the diamonds and the pattern are not particularly limited. However, two rows have been shown to provide sufficient support.

[0128] The structural support may include one or more resilient components which may define a substantially sinusoidal, crenellated or sawtooth pattern.One or more components may be provided having the same or different patterns.

[0129] The mouth has a preset configuration corresponding to the working configuration of the annulus, as defined above with respect to annuloplasty using a band. The mouth of the device can be defined by an orifice (e.g., a distal orifice) of the support structure. The orifice may or may not include a band as described above with respect to annuloplasty using a band.

[0130] In the context of the present delivery systems and methods, it is envisaged to use an annuloplasty device according to the first example comprising a structural support as described with respect to the annuloplasty device according to the second example. In other words, the annuloplasty device may comprise a band and a structural support.

[0131] The annuloplasty device may include a member for anchoring the ostium to the annulus. The anchoring member may be the same as or different from the anchoring member described with respect to annuloplasty using a band. Preferably, the anchoring member extends from the ostium of the support structure. The anchoring member may extend substantially longitudinally from the ostium of the support structure, or extend inwardly at an angle relative to the ostium of the support structure.

[0132] According to a third example, an annuloplasty device may include: a bridge structure having a first end and a second end; a first member for anchoring the annuloplasty device to the annulus at the first end of the bridge structure; and a second member for anchoring the annuloplasty device to the annulus at the first end of the bridge structure; wherein the annuloplasty device is expandable from a preset configuration, wherein the preset configuration of the annuloplasty device is configured to support the annulus in its working configuration.

[0133] refer to Figure 1 , which illustrates an annuloplasty device 1 for restoring a heart valve annulus A from a dysfunctional structure to a working structure, wherein the device 1 comprises a band 2 that can be expanded from a preset structure, wherein the preset structure of the band 2 corresponds to the working structure of the annulus A.

[0134] exist Figure 1 In the example shown in FIG. 1 , the annuloplasty device 1 comprises an occlusive band 2 which is tubular and formed of a mesh. The mesh structure can be expanded (e.g. Figure 1 a) and can also be compressed (as shown in Figure 1 b). The structure may have a pattern such as a grid, diamond, zigzag, crenelated, sinusoidal, vortex, spiral and / or other pattern. Alternatively, the band 2 may be a solid band. The band 2 may include an elastic material or a shape memory alloy such as Nitinol.

[0135] With 2 in Figure 1 , which corresponds to the working configuration of the valve ring A. Figure 1 In a, the band 2 is shown in an expanded anchoring configuration, wherein the size of the band 2 can be expanded in directions d1 and / or d2 to reach the attachment site of the annulus A. Figure 1 In b, the band 2 is shown in a compressed delivery configuration, wherein the band 2 is compressed into the delivery catheter 3 so that the band 2 can be pushed along the inner lumen of the delivery catheter 3. Figure 1 In c, the belt 2 comprises an exemplary anchoring member 4 in the form of a peg. The anchoring member 4 is connected to the belt 2 partially or completely along the belt 2.

[0136] exist Figure 2 In the example illustrated in , the annuloplasty device 1 comprises an open band 2 which is tubular and formed of a mesh. Figure 2 The band in is shown in an exemplary curved preset configuration that corresponds to the working configuration of valve ring A.

[0137] exist Figure 2 In a, the band 2 is shown in an expanded anchored configuration, wherein the size of the band 2 can be expanded in direction d1. Upon release of the expanded band 2, the band 2 retracts to its preset configuration in direction d3.

[0138] exist Figure 2 In b, the band 2 is shown in a compressed delivery configuration, wherein the band 2 is compressed into the delivery catheter 3 so that the band 2 can be pushed along the inner lumen of the delivery catheter 3. The band 2 can be compressed so that its radial dimension is reduced, or the band 2 can be folded upon itself to reduce its overall longitudinal dimension. Figure 2 In c, the strap 2 comprises an exemplary anchoring member 4 in the form of a hook. The anchoring member 4 is connected to the strap 2 partially or completely along the strap 2.

[0139] exist Figure 3 In the preferred example illustrated in , the annuloplasty device 1 includes a substantially saddle-shaped band 2. The shape of the band 2 in its preset configuration corresponds to the working configuration of the annulus A and restores the annulus A to its working configuration. As described above, due to the material and / or structure of the band 2, the band 2 can be expanded in any direction (not shown). In the expanded configuration, the band 2 reaches and anchors to the attachment site of the degenerated or dilated annulus A. When the band 2 is released from its expanded configuration, the band 2 returns to its preset configuration, thereby reshaping the annulus A to its working configuration.

[0140] 6a to 6h are top views of exemplary preset working configurations of the annuloplasty device 1. The device 1 is preferably three-dimensionally shaped to correspond to the three-dimensional shape of a working valve ring and / or to restore a dysfunctional valve ring to a working configuration. The device 1 can have a closed shape (as shown in FIGS. 6i to 6c) to surround the valve. Alternatively, the device 1 can have an open shape (as shown in FIGS. 6d to 6h) to partially surround the valve and restore the valve.

[0141] 7a to 7c are provided to illustrate additional or alternative features of annuloplasty devices as described above (reference to "crown-type" annuloplasty devices). Annuloplasty device 20 is provided with: a support structure 21 including a distal ostium 22, wherein the support structure 21 is expandable from a preset configuration (FIG. 7b), wherein the preset configuration of the ostium 22 corresponds to the working configuration of the annulus; and means 23 for anchoring the ostium to the annulus.

[0142] In Fig. 7a, the annuloplasty device 20 is illustrated in its delivery configuration, folded to fit within the delivery catheter 3. In this embodiment, the annuloplasty device 20 is in its folded configuration having smaller outer dimensions than those of the preset configuration.

[0143] In Fig. 7b, annuloplasty device 20 is shown in its expanded configuration. During the implantation procedure, support structure 21 is expanded (with the aid of a delivery device not shown) so that the size of ostium 22 is larger than the size of the annulus and larger than the size of ostium 22 in the preset configuration.

[0144] Once properly positioned, the device 20 is released to allow the anchoring members 23 (comprising barbs in this embodiment) to grasp and anchor to or in the peri-annular tissue. The mouth 22 returns to its preset configuration, as shown in FIG. 7c, thereby returning the annulus to the working configuration.

[0145] In Figures 7a to 7c, the anchoring member 23 extends longitudinally from the support structure 21. However, the anchoring member 23 can extend inwardly relative to the mouth and / or the support structure, as shown in Figures 8a and 8b. This inward angle has the advantage of improving the grip and anchoring of the patient's tissue.

[0146] In situ, the support structure 21 may extend away from the annulus, or may be positioned partially or completely through the annulus.

[0147] Fig.14 and Fig.15Additional or alternative features of an annuloplasty device as described above with reference to another crown-type annuloplasty device 20 including an anchoring member 23 are illustrated. In this embodiment, the annuloplasty device 20 can be integrally formed of a resilient material, such as a shape memory material. The annuloplasty device 20 can also include an attachment portion 40 that can extend longitudinally from the direction of the anchoring member 23, but in a direction opposite to the direction of the anchoring member 23. The annuloplasty device 20 can include a lever portion that can extend inwardly from the body (e.g., the crown) of the annuloplasty device 20. In Fig.14 In the expanded configuration shown in FIG, the lever portion can be pushed downward or in the distal direction so that the anchor member 23 expands outward. Fig.15 In the preset configuration illustrated in , the lever portion is constructed and arranged to not block the orifice of the annuloplasty device. The annuloplasty device may include a reinforcing portion (illustrated as a handle between the anchoring portion and the attachment portion) to provide rigidity and thus stability to the annuloplasty device when the annuloplasty device is expanded.

[0148] FIG. 9 is provided to illustrate additional or alternative features of annuloplasty devices as described above. Annuloplasty device 30 is provided with a bridge structure 31. Annuloplasty device 30 has a first band 32A and a second band 32B. Annuloplasty device 30 has a first member 33A for anchoring the first band 32A to the annulus and a second member 33B for anchoring the second band 32B to the annulus, wherein the annuloplasty device 30 is expandable from a preset configuration, wherein the preset configuration of the annuloplasty device 30 is configured to support the annulus in its working configuration.

[0149] The bridge structure 31 may include or be composed of a resilient material, such as a shape memory material (e.g., Nitinol), in the form of one or more ribbons or wires, or a mesh (which may be an expandable mesh structure as illustrated with respect to a "crown-type" annuloplasty device.

[0150] In some embodiments, the bridge may include a plurality of straps or wires connected to each other by means of ridges 34 .

[0151] The annuloplasty device 30 may include a resilient bridge structure 31 including at least one anchor at each end thereof. The annuloplasty device 30 may be folded for delivery through a sheath. The annuloplasty device 30 may be deployed when out of the sheath. The annuloplasty device 30 may be expanded or stretched beyond its preset configuration. The annuloplasty device 30 may be anchored to the annulus with the aid of an anchoring member and released into its preset configuration.

[0152] The anchoring members 33A, 33B may be the same or different than the anchoring members described with respect to the previous annuloplasty devices. In a preferred embodiment, the anchoring members 33A, 33B include a pin portion 34 for anchoring into the patient's tissue and an attachment portion 35 for attaching the annuloplasty device to a delivery device. The pin portion 34 and the attachment portion 35 may be integrally formed. The anchoring members 33A, 33B may be integrally formed with their corresponding bands 32A, 33A, or may be mechanically coupled to them.

[0153] Fig. 9C A preferred anchoring member for use in the context of the present disclosure is illustrated, and may be used with any annuloplasty device as described herein.

[0154] The anchoring member includes an attachment portion 40 to removably couple the annuloplasty device to a delivery device. The attachment portion 40 may include a substantially elongated member and may have a circular cross-section (although other cross-sectional configurations are contemplated).

[0155] The anchoring member comprises an anchoring portion 41 intended to penetrate patient tissue. The anchoring portion 41 may be substantially pin-shaped, for example, may comprise a substantially tapered (sharp) end. The pin shape is preferred over, for example, a barb or a screw, because during the anchoring process, anchoring portions comprising barbs or screws tend to dig holes around themselves when entering patient tissue, making them tend to hold less securely. In contrast, a pin is less traumatic and is held due to the inward force of the expandable annuloplasty device.

[0156] The attachment portion 40 and the anchoring portion 41 may be integrally formed or may be mechanically coupled to each other. In a preferred embodiment, the attachment portion 40 and the anchoring portion 41 are integrally formed. The attachment portion 40 and the anchoring portion 41 may form an angle α of 135° or 180°. The angle α may be comprised between 90° and 180°, preferably between 135° and 180°. The value of the angle α depends on the amount of expansion required to provide optimal access to the tissue and optimal grasping of the tissue.

[0157] In the context of the present disclosure, anchoring members can be configured in a preset configuration such that they extend vertically inwardly or outwardly from the body (e.g., band, ring, crown, and / or support) of the annuloplasty device. The anchoring members can be positioned along the body of the annuloplasty device in a symmetrical, concentric, asymmetrical, or non-concentric manner.

[0158] An annuloplasty device can be used to minimize or prevent further degeneration of the annulus, to improve or restore function of the annulus and / or for palliative support. The device is simple and standardizable. Development of the device and implantation in a patient becomes less resource intensive than conventional devices. The annuloplasty device can be delivered and implanted using a minimally invasive transcatheter approach according to the present disclosure. The annuloplasty device is easily attached to a dysfunctional annulus to restore it to a healthy working configuration. As will be described below, the annuloplasty device can be conveniently and accurately delivered using systems and methods according to the present disclosure, which requires minimal in situ manipulation, positioning and adjustment. The training required for medical practitioners is not as extensive as that required to implant a conventional annuloplasty device. Importantly, the annuloplasty device does not simply reduce the opening of the valve, but rather restores the shape of the annulus, particularly the three-dimensional shape.

[0159] Delivery System

[0160] Referring to Figure 10, a system 100 for delivering annuloplasty devices 1, 20, 30 for restoring a heart valve annulus from a dysfunctional structure to a working structure is illustrated, wherein the annuloplasty devices 1, 20, 30 are configured to expand from a preset structure corresponding to the working structure of the valve annulus, and the system 100 includes a delivery device 101, which is configured to be detachably connected to the annuloplasty devices 1, 20, 30, wherein the delivery device 101 includes a structure 102, which is configured to expand from a first structure to a second structure, wherein the size of the second structure is substantially equal to or greater than the size of the preset structure of the annuloplasty devices 1, 20, 30.

[0161] exist Fig. 10A , Fig. 10B , Fig. 10C In the embodiment illustrated in , the delivery system 100 includes a delivery device 101 including an expandable structure 102 positioned at or adjacent to a distal end 103a of a shaft 103 .

[0162] The expandable structure 102 includes a plurality of arms 104. Each arm 103 includes a proximal end and a distal end. Fig. 10A , Fig. 10B , Fig. 10C , the proximal end of the arm 104 is coupled to the shaft 103 (e.g., adjacent to or at the distal end 103 of the shaft 103). The proximal end of the arm 104 is pivotally coupled to the shaft 103 and is constructed and arranged to pivot about the distal end 103a (e.g., about the point where the proximal end of the arm 104 is connected to the shaft 103).

[0163] Fig. 10AThe arms 104 in FIG. 1 are shown in a first substantially folded configuration suitable for fitting the delivery device 101 through a delivery sheath (not shown).

[0164] exist Fig. 10B , arms 104 are shown in a second configuration, wherein the dimensions of the second configuration are substantially the same as the dimensions of the preset configuration of the annuloplasty device. In other words, the expandable structure (more particularly, the distal ends of arms 104) define a space that is substantially the same as the dimensions of the preset configuration of the annuloplasty device 1, 20, 30.

[0165] exist Fig. 10C , arms 104 are shown in a second configuration, wherein the dimensions of the second configuration are larger than the dimensions of the preset configuration of the annuloplasty device. In other words, the expandable structure (more particularly, the distal ends of arms 104) define a space that is larger than the dimensions of the preset configuration of the annuloplasty device 1, 20, 30.

[0166] The delivery device 102 includes an actuation rod 105 and a plurality of stretchers 106. The actuation rod 105 is slidably received in the lumen of the shaft 103, and a distal end of the actuation rod 105 extends beyond a distal opening of the lumen of the shaft 103.

[0167] Each stretcher 106 has a proximal end and a distal end. In this example, the distal end of the stretcher 106 is pivotally connected to the actuating rod 105 adjacent to the distal end of the actuating rod 105. The distal end of the stretcher 106 can be directly connected to the actuating rod 105, or can be connected to a slider or connector, which is attached to the actuating rod 105. The proximal end of the stretcher 106 is connected to one or more arms 104. Each arm 104 includes a proximal end, a distal end, and a middle portion extending therebetween. In this example, the proximal end of the stretcher 106 is connected to the middle portion of the arm 104 adjacent to the midpoint of the arm 104.

[0168] Alternative or additional expansion mechanisms are contemplated involving, for example, a balloon positioned between the arms 104 that can be selectively inflated and deflated to expand or collapse the arms 104, or involving resilient or shape memory arms 104 that are constructed and arranged to automatically deploy upon exiting the delivery sheath. In the latter embodiment, a retraction mechanism is required to collapse the arms and / or release the annuloplasty device. However, it should be noted that balloon expansion mechanisms are less preferred because they tend to block blood flow through the annulus during the delivery process.

[0169] exist Fig.11A , Fig. 11B , Fig. 11CIn the embodiment illustrated in FIG. 1 , the delivery system 100 may include a delivery device 101 including an expandable structure 102, a shaft 103, an arm 104, an actuator rod 105, and a stretcher 106, such as Fig. 10A , Fig. 10B , Fig. 10C As described in the embodiments.

[0170] The arm 104 may include a recess 107 that is constructed and arranged to receive the stretcher 10, particularly when the expandable structure 102 is in a folded configuration, such as Fig.11A As shown in the figure.

[0171] Delivery device 101 includes one or more connectors for removably coupling expandable structure 102 to annuloplasty device 1, 20, 30. These connectors may include a removable ring connector 110 or a hook connector 111, such as Fig. 12A and Figure 1B As shown in the figure.

[0172] The connector structure includes a plurality of ribs 108. The ribs 108 include a proximal end and a distal end, and in this example, the proximal end of the ribs 108 is coupled to the shaft 103. The distal end of the ribs 108 can be coupled to the distal end of the arm 104 directly or via a connector outlet 109.

[0173] The ribs 108 are constructed and arranged so as not to impede the movement of the arm 104. For example, the ribs 108 may include or consist of a flexible material.

[0174] One or more ribs 108 may include a channel (not shown) for accommodating a connector control line (not shown). The channel and connector control line may extend from the proximal user side to the connector outlet 109.

[0175] The connector outlet 109 may include a lumen (not shown) that is constructed and arranged to receive an anchor member, or more specifically, an attachment portion 40 of an anchor member.

[0176] The lumen of the connector outlet 109 can have a size that is (slightly) larger than the outer dimensions of the anchoring member or its attachment portion 40. In this configuration, the attachment portion 40 is retained in the lumen due to the relative dimensions of the lumen and the lumen of the connector outlet 109. The attachment portion 40 can be removed from the connector outlet 109 due to the relative dimensions of the lumen and the lumen of the connector outlet 109. In other words, the anchoring member or its attachment portion 40 is retained (by relative construction or by friction) because the internal dimensions of the lumen are only slightly larger than the internal dimensions of the anchoring member or its attachment portion 40. Other retaining members can be envisioned, including but not limited to tabs, clips, screws, hooks and the like. The delivery device may include a member for pushing the anchoring member out of the lumen of the connector outlet 109.

[0177] The connector outlet 109 can be configured to allow, for example, a hook connector 111 or a loop connector 110 to pass therethrough. The connector outlet 109 can be movable, for example, pivotable, relative to the arm 104. The connector outlet 109 can include a substantially flat surface or a substantially curved surface to prevent the distal end of the arm 104 from injuring the patient.

[0178] The delivery device 100 may include a rail (not shown) extending from the arm 104. The rail may be coupled to or coupleable to the arm 104. The rail may slide along or be received within the arm 104 so as to extend beyond the distal end of the arm 104.

[0179] In the context of the present disclosure, a control device for a delivery device as described herein is also provided. The control device includes a control unit and a catheter extending therefrom. The catheter may be constructed and arranged to receive the delivery device 100 and an annuloplasty device.

[0180] The catheter of the control device may include support rods (preferably made of a relatively rigid material) to facilitate alignment and positioning of the delivery device, and thus improve alignment and positioning of the annuloplasty device. The catheter of the control device may include bends or curvatures to facilitate maneuverability.

[0181] The control unit may include components for controlling rotation, extension and / or retraction of the delivery device, components for controlling folding and / or expansion of the delivery device, components for controlling extension and / or retraction of the guide rails, components for controlling release of the annuloplasty device, and the like.

[0182] The delivery system may be provided with a positioning device.The positioning device may be provided as a separate tool, which may be coupled to one or more elements of the delivery system or simply used in combination with a delivery system as described in the present disclosure.

[0183] The positioning device is constructed and arranged to modify the configuration of the annulus before and during implantation of the annuloplasty device. Thus, the annulus is optimally configured to receive the annuloplasty device.

[0184] The positioning device may include an expandable structure that may be self-expanding or controllably expandable. In the expanded state, an outer contour of the positioning device contacts and / or applies pressure to an inner contour of the annulus. In a passive reconfiguration step, the positioning device may act as a stabilizer by substantially preventing movement of the annulus during implantation of the annuloplasty device. In an active reconfiguration step, the positioning device may be used to adjust and / or maintain the annulus in a desired configuration. Thus, an expanded or degenerated annulus may be arranged and stabilized in a receiving configuration to receive the annuloplasty device.

[0185] The self-expandable positioning device may include a shape memory material (such as Nitinol) and / or a resilient element (such as a spring).

[0186] Additionally or alternatively, the positioning device may include multiple arms or pedicles that can be radially extended relative to the central column. The positioning device may have a configuration substantially as depicted in any one of Figures 10 to 12 and as described above with respect to the delivery system. In one embodiment, the delivery system may be used as the positioning device.

[0187] In one embodiment, a separate positioning device may be provided. For example, the positioning device may be inserted first to configure or reconfigure the annulus into a receiving configuration, and the delivery system may then be used to position and anchor the annuloplasty device. In one embodiment, the delivery device and the positioning device share the same shaft 103 or post. In one embodiment, the post of the positioning device is longitudinally aligned, e.g., concentrically aligned, with the shaft 103 of the delivery device. In one embodiment, the shaft 103 of the delivery device is arranged to slidably receive the unexpanded positioning device. Alternatively, the positioning device may be delivered to the implantation site via a separate catheter or sheath.

[0188] In one embodiment, the positioning device comprises a cage, which may be spherical, elliptical, hourglass, conical or bell-shaped. The cage may be open or closed.

[0189] The cage may include an exoskeleton for contacting the annulus. The exoskeleton may include or be configured as a guide rail for guiding the annuloplasty device into an anchoring position on the annulus. In one embodiment, the exoskeleton includes a substantially smooth and / or flat outer surface for atraumatically contacting the annulus.

[0190] In one embodiment, the positioning device may include a plurality of feet or pads. The feet or pads may be coupled to the pedicles and may pivot relative to each corresponding pedicle.

[0191] In one embodiment, the positioning device or cage is tapered, for example in the shape of a frustoconical cone or bell. In one embodiment, the tapered shape is open ended. The tapered profile is a simple solution for gradual reconfiguration of the annulus and / or for guidance of an annuloplasty device. The tapered shape may include a plurality of stops, notches or tabs to gradually and safely reconfigure the annulus and / or guide an annuloplasty device.

[0192] The cage may include a mesh or a covering. However, an open structure is preferred to allow blood flow during delivery and / or implantation surgery. In addition, a non-obstructive structure is preferred to avoid snagging and tangling during the annuloplasty device implantation process.

[0193] In one embodiment, the positioning device comprises or has a symmetrical outer profile. Such symmetry evenly distributes the pressure applied by the positioning device to the valve annulus, thereby minimizing the risk of tissue trauma or damage.

[0194] Delivery Method

[0195] The present disclosure also relates to a method for restoring a heart valve annulus, comprising the steps of delivering an annuloplasty device for restoring the heart valve annulus from a dysfunctional configuration to a working configuration, wherein the annuloplasty device is configured to expand from a preset configuration corresponding to the working configuration of the valve annulus, the system comprising a delivery device configured to be removably coupled to the annuloplasty device using a delivery system as described herein.

[0196] The method may include any one or more of the following steps:

[0197] - The step of coupling the annuloplasty device to the expandable structure of the delivery device.

[0198] - The step of compressing the annuloplasty device by means of a delivery device to slidably fit within the lumen of a delivery catheter or sheath, thereby delivering the device to the target area.

[0199] - The step of inserting the delivery system into the delivery sheath with the expandable structure in a collapsed configuration.

[0200] - The step of expanding the expandable structure into a second configuration.

[0201] - The step of expanding or deforming the annuloplasty device to a size equal to or greater than the size of the heart valve annulus so as to contact the anchoring site on the dilated annulus.

[0202] - A step of anchoring the annuloplasty device by releasing the expanded band to its preset configuration.

[0203] - The step of releasing the annuloplasty device into its preset configuration.

[0204] Preferably, the heart valve is a mitral valve, and the annulus is an anterior annulus, a posterior annulus, a lateral commissure, and / or a medial commissure. Most annuloplasty procedures are intended to reduce the size of the posterior annulus. However, it is also known that the portion between the anterior and posterior annulus (the commissure) will elongate over time and can be reshaped using an annuloplasty device as described herein. Preferably, the heart valve is a tricuspid valve, and / or the annulus is an anterior annulus, a posterior annulus, and / or a septal annulus.

[0205] In the context of the present disclosure, annuloplasty devices, delivery devices, and corresponding methods may be used for repair of the aortic valve or the pulmonary valve.

[0206] In the context of the present disclosure, annuloplasty devices, delivery devices, and corresponding methods can be used for repair of the valve annulus, including any structural degeneration through the valve annulus and adjacent to the valve annulus. For example, annuloplasty devices, delivery devices, and corresponding methods can be used in the context of paravascular leak (PVL).

[0207] A method for repairing a heart valve using a Figure 3 Annuloplasty device 1 is illustrated in FIG. 1 . It should be noted here that the method and system according to the present invention can be used with any annuloplasty device as described herein.

[0208] The annuloplasty device 1 is removably connected to the delivery system 100 .

[0209] In a preferred embodiment, the annuloplasty device includes an anchoring member having an attachment portion 40. The attachment portion 40 slides into the lumen of the connector outlet 109 (or directly into the lumen of the arm 104, for example, if the delivery device does not include a connector outlet 109).

[0210] Additionally or alternatively, the ring connector 110 can be coupled to the annuloplasty device 1 so as to encompass the diameter of the band or rings 2. Alternatively, the hook connector 111 can be coupled to the annuloplasty device 1 so as to partially encompass the diameter of the band or rings 2. The annuloplasty device 1 can be coupled to the delivery system 1 when the expandable structure 102 is in the second configuration, e.g., as Fig. 10B as shown in .

[0211] Other types of annuloplasty devices, such as a “crown-type” annuloplasty device 20 and a “bridge-type” annuloplasty device 30 may be coupled to the delivery device 101 in a similar manner.

[0212] The actuation rod 105 of the delivery device 101 extends in a proximal to distal direction. The expandable structure 102 may be, for example, Fig. 10Aand Fig.11A folded as shown in , thereby compressing the annuloplasty device into a folded configuration. The annuloplasty device 1 connected to the delivery device 101 is ready for insertion into the delivery catheter 3. The delivery catheter 3 may be connected to a control device (not shown).

[0213] When the distal end of the catheter is adjacent to the annulus, the annuloplasty device 1 is pushed by the delivery device along the length of the catheter 3. The distal end of the delivery catheter 3 is positioned adjacent to the pathologically degenerated annulus A.

[0214] The annuloplasty device 1 may naturally return to its preset configuration when the device 1 exits the delivery catheter 3. Additionally or alternatively, the actuation rod 105 of the delivery device 101 is retracted through the lumen of the shaft 103 in a distal-to-proximal direction, thereby expanding the expandable structure 102.

[0215] The proximal end of the arm 104 is pivotally connected to the shaft 103. The proximal end of the tensioner 106 is pivotally connected to the shaft 103. When the actuation rod 105 is retracted, the arm 104 and the tensioner 106 are pushed against each other so that the arm 104 and the tensioner 106 expand radially outward and away from the actuation rod 106.

[0216] The expansion structure 104 expands to its second configuration, the size of which is larger than the size of the preset configuration of the annuloplasty device 1. That is, the expansion structure 104 and, for example, the distal ends of the arms 104 define a space whose size is larger than the size of the preset configuration of the annuloplasty device 1 in order to expand the annuloplasty device 1 from its preset configuration.

[0217] The annuloplasty device 1 is positioned so that its contour corresponds to the overall contour of the annulus (eg Figure 3 For example, finer adjustments may be made by extending one or more arms 104 of the delivery device 101.

[0218] For a better understanding of the present invention, refer to FIG. 4a, FIG. 4b and FIG. Figure 5 , which illustrates the anatomical structure of the mitral valve 5 and the tricuspid valve 6.

[0219] The mitral valve 5 includes an anterior leaflet 7, a posterior leaflet 8, an outer leaflet 9 and an inner leaflet 10. The tricuspid valve 6 includes an anterior leaflet 11, a posterior leaflet 12 and a septal leaflet 13.

[0220] The mitral valve 5 and the tricuspid valve 6 do not have a planar configuration, but rather a curved and saddle-shaped configuration. Figure 5 A relatively high region H and a relatively low region L are shown. The annuloplasty device 1 preferably does not have a substantially planar configuration. Instead, the device 1 is curved and preferably saddle-shaped so as to follow the natural configuration of the annulus A.

[0221] The device 1 is positioned adjacent to the annulus A so that the device 1 is located above the annular region to be reshaped. The region may be the entire periphery of the annulus A, or one or more portions of the annulus A. For example, a saddle-shaped device 1 may be used to reshape the entire annulus, or an open band device 1 may be used to reshape only the posterior leaflets 8, 12, for example.

[0222] From this position, and using the delivery device 101, the annuloplasty device 1 is expanded from its preset configuration so that the anchoring member 4 reaches the attachment site of the degenerated annulus. The attachment sites are preferably such that the configuration they outline has a larger size than the preset configuration of the annuloplasty device 1. Thus, in order to grasp and anchor to the attachment site of the annulus A, the annuloplasty device 1 is expanded.

[0223] If the delivery device 101 includes rails, the rails may extend beyond the distal ends of the arms 104 until the distal ends of the rails contact the patient's tissue. Thus, the user may assess the anchoring site of the annuloplasty device 1 before releasing the annuloplasty device 1 .

[0224] Once the annuloplasty device 1 is properly positioned, it can be released. This can be achieved, for example, by pushing or pulling the anchoring member out of the connection outlet 109.

[0225] If the delivery device 101 includes a rail, the annuloplasty device 1 may be slid along the rail to reach the target anchoring location.

[0226] Upon release of the annuloplasty device 1, as the annuloplasty device 1 returns to its preset configuration, the anchoring member 4 is pressed into and secured to the tissue of the annulus A. Alternatively or additionally, the delivery device 101 may be used to press on the anchoring member 4, and / or the arm 104 may be used to manipulate and / or rotate the band 2 so that the anchoring member 4 (e.g., hook) grasps the annulus A and secures to the annulus A.

[0227] Once the annuloplasty device 1 is properly positioned and expanded, the anchoring member 4 is anchored to the attachment site of the annulus A. The annuloplasty device 1 may be sutured to the attachment site. However, it is preferred to avoid such a complicated and irreversible procedure by providing the annuloplasty device 1 with an anchoring member. The anchoring member 4 may be a hook or a peg or other member that can be pushed into the tissue of the annulus A.

[0228] It is also contemplated that the annuloplasty device 1 is anchored to the "back" of the annulus, for example on the ventricular side of the annulus. In this embodiment, the delivery sheath 3 is pushed through the annulus until the distal end of the sheath 3 is positioned beyond the annulus. The annuloplasty device 1 is pushed forward and deployed upon exiting the delivery sheath 3. The annuloplasty device 1 is expanded beyond its preset configuration and appropriately positioned to capture the annulus. The annuloplasty device 1 is anchored to the back of the annulus and released into its preset configuration.

[0229] Providing structural support to the back of the annulus may be advantageous if the back of the annulus is better defined, has better tissue integrity, and provides a more suitable anchoring site. In addition, the anchoring step can be improved by using traction (from the proximal to distal direction) on the annuloplasty device 1 to provide greater anchoring force.

[0230] A problem with conventional annuloplasty rings is that their implantation is difficult to reverse. In other words, in the event of an unsuccessful implantation, the ring cannot be easily removed and repositioned. In the present invention, an anchoring member 4 can be used that is secured to the annulus by pressure from the annuloplasty device 1 (due to its pre-configuration) so that if the annuloplasty device 1 needs to be repositioned, expansion of the device 1 will release the anchoring member 4. The annuloplasty device 1 can be repositioned with minimal trauma to the annulus A.

[0231] Furthermore, when the annuloplasty device 1 is first released, the annuloplasty device 1 is still coupled to the delivery device 101 by means of the ring 110 or the hook 111. If the annuloplasty device 1 is not positioned correctly, the annuloplasty device 1 can be re-retrieved by pulling back the ring 110 to which the annuloplasty device 1 is coupled.

[0232] Once the annuloplasty device 1 is securely anchored to the annulus, it can be detached from the delivery device 101. Where the annuloplasty device 1 is connected by means of a ring connector 110, the connector 110 can be detached by pulling on one end of the connector wire to release the annuloplasty device 1. Alternatively, the ring can be severed simply by pulling on the connector wire to break the ring and release the annuloplasty device 1, or by other mechanical or chemical means. Where the annuloplasty device 111 is connected by means of a resilient or shape memory hook connector 111, the connector wire can be pulled to retract the hook 111 through the connector outlet 109.

[0233] The expandable structure 102 can be collapsed by extending the actuation rod 105 in the proximal to distal direction. The delivery device 101 can be retracted into the delivery catheter 3.

[0234] In one embodiment, an expanded and / or degenerated annulus may be (re)configured with the aid of a positioning device prior to implantation of an annuloplasty device.

[0235] The positioning device can be inserted into the delivery sheath and positioned adjacent to the annulus. Alternatively, the positioning device can be inserted into the shaft 103 of the delivery system and pushed into position adjacent to the annulus.

[0236] The positioning device can be delivered in an antegrade or retrograde manner. The positioning device can be delivered from a first side of the annulus, pushed through the annulus and beyond the annulus, and pulled back toward the annulus for positioning.

[0237] The positioning device is positioned in the opening of the valve annulus and expanded. The expansion can be self-expanding or expansion controlled and adjusted by a medical professional outside the body.

[0238] The expansion can make the shape of the valve ring be stabilized and effectively held by the expanded positioning device. In this case, little or no pressure is applied to the valve ring, and the positioning device acts as a stabilizer.

[0239] The expansion can cause the shape of the annulus to be reconfigured into a desired configuration. The reconfiguration can be planar (e.g., expansion of the inner diameter of the annulus) or non-planar (e.g., three-dimensional reconfiguration). In this case, pressure can be applied to the annulus by increasing and / or controlling the expansion of the positioning device. If the positioning device includes arms or pedicles, the arms of the pedicles can be adjusted together or independently of each other.

[0240] Once the annulus is disposed in its anchored configuration, ready to receive the annuloplasty device, the annuloplasty device may be positioned, expanded and released as described above. The positioning device may be arranged and configured to guide the annuloplasty device to a pre-release configuration and position.

[0241] For example, the positioning device may be frustoconical or bell-shaped. A positioning device comprising an expandable cage may be positioned within a cone or bell-shaped member to control the extent of expansion of the cage. Where the positioning device comprises a plurality of arms, each arm may slide along a guide rail on an exoskeleton of the positioning device so as to be guided to a suitable pre-release position.

[0242] Once the annuloplasty device is anchored to the annulus, the positioning device may be removed. This may be before or after the annuloplasty device is released into its working configuration.

[0243] The positioning device prepares the annulus to receive the annuloplasty device. The annulus is stabilized in that movement of the annular tissue is minimized during anchoring. The annulus is braced so that a stable anchoring region is available that can be targeted, clamped, and / or penetrated. This can be achieved, for example, by imparting tension to the annular anchoring region. The annulus can be reconfigured into a shape that substantially corresponds to or is complementary to the shape of the annuloplasty device.

[0244] The positioning device may also be used as a guide device for positioning the annuloplasty device.

[0245] Although the present invention is described in the context of heart valves, and in particular annuloplasty procedures, it is contemplated that the present invention may have other advantageous embodiments involving the reshaping of anatomical structures.

[0246] The present invention is particularly beneficial in the context of transcatheter surgery and / or in the cardiovascular field. For example, in transcatheter surgery, an access point is formed through tissue and / or a blood vessel. Annuloplasty devices can be used to restore a blood vessel to its working configuration by partially or completely closing the access point(s), thereby minimizing or preventing blood from flowing outside the blood vessel.

[0247] The present invention can be used in the setting of an atrial septal defect (ASD), i.e., a hole in the atrial septum. An ASD may be congenital or may be the desired result of a medical procedure designed to relieve pressure between the two atrial chambers of the heart. Annuloplasty devices can be used to partially or completely close the hole to minimize or prevent blood flow between the atrial chambers.

[0248] Importantly, the present invention provides systems and methods that are particularly well suited for convenient delivery and accurate positioning of annuloplasty devices.

Claims

1. A system for delivering an annuloplasty device for restoring a heart valve annulus from a dysfunctional configuration to a working configuration, wherein the annuloplasty device is configured to expand from a preset configuration corresponding to the working configuration of the valve annulus, The system includes a delivery device configured to be removably coupled to the annuloplasty device, The delivery device comprises a structure configured to expand from a first configuration to a second configuration, wherein a dimension of the second configuration is substantially the same as or greater than a dimension of the pre-set configuration of the annuloplasty device.

2. The system of claim 1, wherein the expandable structure comprises a shaft and one or more arms, each arm being movably connected to the shaft.

3. The system of claim 2, wherein the arms are configured to fold radially inwardly into the first configuration.

4. The system of claim 2 or 3, wherein the arms are configured to expand radially outwardly into the second configuration.

5. The system of any one of claims 2 to 4, comprising an actuator for controlling expansion of the expandable structure.

6. The system of claim 5, wherein the actuator comprises an actuation rod slidable relative to a longitudinal axis of the shaft, and a plurality of tensioners coupled to the arm and the actuation rod.

7. The system of claim 6, wherein the shaft comprises one or more lumens, the actuator rod being received in a lumen of the shaft.

8. The system of claim 5, wherein the actuator comprises an actuation sleeve slidable relative to a longitudinal axis of the shaft, and a plurality of tensioners coupled to the arm and the actuation sleeve.

9. The system of claim 8, wherein the actuation sleeve comprises one or more lumens, the shaft being received in a lumen of the actuation sleeve.

10. The system of any preceding claim, wherein the delivery device comprises one or more connectors for removably coupling the expandable structure to the annuloplasty device.

11. The system of claim 10, wherein the connector comprises a detachable loop connector or a hook connector.

12. The system of claim 11, wherein the connector includes one or more ribs constructed and arranged to receive a connector control line.

13. The system of claim 12, wherein the expandable structure comprises a shaft and one or more arms movably connected to the shaft, and wherein the rib comprises a distal end coupled to or adjacent to a distal end of the arm.

14. The system of claim 11, wherein the expandable structure comprises a shaft and one or more arms movably connected to the shaft, wherein the one or more arms are constructed and arranged to receive a connector control line.

15. The system of any one of claims 12 to 14, wherein the rib and / or arm comprises a connector outlet pivotably coupled to the rib and / or arm.

16. A system according to any preceding claim, further comprising a control device comprising a control unit and a conduit extending therefrom.

17. The system of claim 16, wherein the catheter comprises a support rod.

18. A system according to any preceding claim, further comprising the annuloplasty device.

19. A system according to any preceding claim, further comprising a positioning device for setting the valve ring in an anchoring configuration.

20. A method for restoring a heart valve annulus, comprising the step of delivering an annuloplasty device for restoring the heart valve annulus from a dysfunctional configuration to a working configuration, wherein the annuloplasty device is configured to expand from a preset configuration corresponding to the working configuration of the valve annulus, the system comprising a delivery device configured to be detachably coupled to the annuloplasty device using a delivery system according to any one of claims 1 to 16.

21. The method of claim 19, comprising the step of coupling the annuloplasty device to an expandable structure of the delivery device.

22. The method of claim 19 or 20, comprising the step of inserting the delivery system into a delivery sheath with the expandable structure in a collapsed configuration.

23. A method according to any one of claims 19 to 21, comprising the step of expanding the expandable structure into the second configuration.

24. A method according to any one of claims 19 to 22, comprising the step of releasing the annuloplasty device to its preset configuration.

25. The method according to claim 24, further comprising: Prior to releasing the annuloplasty device into its preset configuration, the step of placing the annulus into an anchored configuration.

26. The method according to any one of claims 19 to 24, wherein the heart valve is a tricuspid valve and the valve annulus is an anterior valve annulus, a posterior valve annulus and / or a septal valve annulus.

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