Patent Application
20220378577
The present disclosure relates generally to the field of implantable medical devices and imaging thereof. In particular, the present disclosure relates to medical devices, systems, and methods for cardiac treatment.
Various diseases or defects affect proper functioning of the heart. Heart disease can cause the chambers of the heart and/or the valves therebetween to expand and weaken, dangerously affecting proper cardiac function such as blood flow. As a result of aging or disease, the chambers, such as the left ventricle, may dilate and the cardiac muscles, such as the papillary muscles, may be displaced. Heart valve incompetency is a serious problem. As a result of aging or disease, the left ventricle may dilate and the papillary muscles may be displaced, causing the mitral heart valve annulus to dilate excessively. In this state of dilation, the valve leaflets no longer effectively close, or coapt, during systolic contraction. Consequently, regurgitation (i.e., retrograde flow back across the valve that should be closed) of blood occurs during ventricular contraction, and cardia output may decrease as a result, with various associated risks of morbidity and mortality due to stroke, thrombosis, heart attack and extended recovery time.
Various devices are known for addressing heart valve incompetency, such as annuloplasty devices which reshape the valve annulus to bring together the valve leaflets to restore proper coaptation. In particular, various cardiovascular devices are available for minimally-invasive (such as transluminal, e.g., transcatheter) procedures, in contrast with invasive (such as open-surgery), for delivery and deployment of the device. For instance, various annuloplasty devices are configured for delivery and deployment transfemorally and transeptally to the mitral valve. Various components of the devices may be at different angles with respect to one another or with respect to the implant site (e.g., the heart valve annulus). Accordingly, various challenges exist with regard to providing visualization equipment with respect to such devices and to maintaining non-skewed, unblocked, and focused view of the device and/or the anatomy at the treatment site/implant site, such as by maintaining the viewing equipment substantially centered/concentric/coaxial or otherwise positioned as desired relative to the device and/or the anatomy to which the device is to be implanted. Another significant procedural challenge is the ability to image the device, the implant site (e.g., mitral valve annulus), and the specific target locations for anchor placement.
This summary of the disclosure is given to aid understanding, and one of skill in the art will understand that each of the various aspects and features of the disclosure may advantageously be used separately in some instances, or in combination with other aspects and features of the disclosure in other instances. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, or the like in this summary.
In one general aspect, an implant system formed in accordance with various principles of the present disclosure, includes an implantable device, a delivery/deployment system configured to deliver the implantable device to a deployment site, a visualization/imaging system, and an access sheath defining a common access lumen through which the implantable device, the delivery/deployment system, and the visualization/imaging system are delivered to the deployment site. In some embodiments, the delivery/deployment system includes a flexible elongate member. In some embodiments, at least one imaging element is positioned on a portion of the flexible elongate member. In some embodiments, the portion of the flexible elongate member on which the imaging element is positioned is movable with respect to the longitudinal axis of the flexible elongate member to alter the position of the imaging element relative to at least one of the implantable device or the implant site.
In some embodiments, the at least one imaging element is positioned on the distal end of the flexible elongate member, and the distal end of the flexible elongate member is deflectable into a bent configuration with respect to the longitudinal axis of the flexible elongate member upon exiting the access lumen of the delivery catheter to alter the position of the at least one imaging element.
In some embodiments, the at least one imaging element is positioned on the distal end of the flexible elongate member, and the distal end of the flexible elongate member is flexible and steerable.
In some embodiments, more than one imaging elements are positioned circumferentially about the flexible elongate member.
In some embodiments, more than one imaging elements are positioned longitudinally along the flexible elongate member. Optionally, at least one imaging element is positioned on the distal end of the flexible elongate member, and the distal end of the flexible elongate member is bendable to adjust the relative angle between the more than one imaging elements.
In some embodiments, the flexible elongate member includes first and second flexible elongate members each having a distal end with at least one imaging element positioned thereon.
In some embodiments, the flexible elongate member has a bifurcated distal end forming first and second distal ends with at least one imaging element positioned on each of the first and second distal ends.
In some embodiments, the implant system further includes a delivery catheter defining a delivery lumen therethrough through which the delivery/deployment system and the visualization/imaging system are delivered to the implant site.
In some embodiments, the implantable device circumscribes an area, and the visualization/imaging system is positioned within the circumscribed area.
In some embodiments, the visualization/imaging system includes an intracardiac echocardiography catheter.
In one general aspect, an implant system formed in accordance with various principles of the present disclosure includes a tubular implantable device circumscribing an area, and a visualization/imaging system positioned within the circumscribed area and including a flexible elongate member with a distal end carrying at least one imaging element. In some embodiments, the distal end of the flexible elongate member is movable with respect to the longitudinal axis of the flexible elongate member to alter the position of the at least one imaging element relative to at least one of the implantable device and/or the implant site.
In some embodiments, the implant system further including a delivery/deployment system configured to deliver the implantable device to a deployment site, where the visualization/imaging system is positioned within the delivery/deployment system.
In some embodiments, at least a section of the distal end of the flexible elongate member is formed of a shape memory material which deflects the distal end into a bent configuration.
In some embodiments, the distal end of the flexible elongate member is flexible, the implant system further including a steering mechanism coupled to the flexible distal end of the flexible elongate member to bend the flexible distal end of the flexible elongate member to alter the position of the at least one imaging element.
In one general aspect, a method of deploying an implant system includes delivering an implantable device and a visualization/imaging system through a common lumen defined through an access sheath to an implant site, and causing a distal end of a flexible elongate member of the visualization/imaging system to move with respect to the longitudinal axis of the flexible elongate member to move an imaging element on the distal end of the visualization/imaging system relative to the implantable device and/or the implant site.
In some embodiments, the distal end of the flexible elongate member is moved to exit the common lumen and allowed to deflect into a bent configuration.
In some embodiments, the distal end of the flexible elongate member is steered with a steering system.
In some embodiments, the implantable device circumscribes an area, and the visualization/imaging system is delivered into the circumscribed area.
In some embodiments, the implantable device is delivered with a delivery/deployment system delivered with a delivery catheter through which the visualization/imaging system is also delivered.
These and other features and advantages of the present disclosure, will be readily apparent from the following detailed description, the scope of the claimed invention being set out in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be appreciated that individual aspects can be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.
Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for purposes of illustration only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may vary. For example, devices may be enlarged so that detail is discernable, but is intended to be scaled down in relation to, e.g., fit within a working channel of a delivery catheter or endoscope. In the figures, identical or nearly identical or equivalent elements are typically represented by the same reference characters, and similar elements are typically designated with similar reference numbers differing in increments of 100, with redundant description omitted. For purposes of clarity and simplicity, not every element is labeled in every figure, nor is every element of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure.
The detailed description will be better understood in conjunction with the accompanying drawings, wherein like reference characters represent like elements, as follows:
The following detailed description should be read with reference to the drawings, which depict illustrative embodiments. It is to be understood that the disclosure is not limited to the particular embodiments described, as such may vary. All apparatuses and systems and methods discussed herein are examples of apparatuses and/or systems and/or methods implemented in accordance with one or more principles of this disclosure. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles but are merely examples. Thus, references to elements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the present subject matter. For instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.
It will be appreciated that the present disclosure is set forth in various levels of detail in this application. In certain instances, details that are not necessary for one of ordinary skill in the art to understand the disclosure, or that render other details difficult to perceive may have been omitted. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless defined otherwise, technical terms used herein are to be understood as commonly understood by one of ordinary skill in the art to which the disclosure belongs. All of the devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.
As used herein, “proximal” refers to the direction or location closest to the user (medical professional or clinician or technician or operator or physician, etc., such terms being used interchangeably herein without intent to limit, and including automated controller systems or otherwise), etc., such as when using a device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and “distal” refers to the direction or location furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery). “Longitudinal” means extending along the longer or larger dimension of an element. “Central” means at least generally bisecting a center point and/or generally equidistant from a periphery or boundary, and a “central axis” means, with respect to an opening, a line that at least generally bisects a center point of the opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a strut, a channel, a cavity, or a bore.
In accordance with various principles of the present disclosure, devices, systems, and methods for delivering and/or deploying an implantable device within a body include a visualization and/or imaging system which is integrated with the system used to deliver and/or deploy the implantable device to the intended treatment site/implant site. As used herein, such terms as treatment site or implant site may be used interchangeably, without intent to limit, to refer to the location within the body to which an implantable device is delivered and to be implanted. More particularly, the visualization and/or imaging system may be navigated with, delivered with, coupled to, or otherwise associated with the system used to deliver and/or deploy the implantable device to be integrated therewith. Integration of a visualization and/or imaging system with an implantable device provides various advantages over current visualization and imaging systems. For instance, in contrast with transesophageal echocardiography (“TEE”), integration of a visualization and/or imaging system with an implantable device allows imaging from the treatment site (e.g., within or adjacent the implantable device), thereby allowing clearer, more accurate imaging. Further, a visualization and/or imaging system which allows movement of the imaging element (e.g., the component of the visualization and/or imaging system receiving images, such as the distal end or tip or free end of a fiber optic, or a transducer of an ultrasound imaging device) relative to the implantable device and/or the implant site provides even further benefits over prior devices, systems, and methods. Reference is made herein to a delivery/deployment device generically to reference a system used to deliver and/or deploy an implantable device. As used herein, reference may be made to deploy, implant, anchor, affix, fix, etc. (and various conjugations and other grammatical forms thereof) interchangeably without intent to limit.
As may be appreciated by those of ordinary skill in the art, visualization systems and imaging systems may have overlapping or common features and functions, such as the ability to determine the position, location, shape, size, configuration, etc. of an object in the field of view of the visualization or imaging system. A visualization system may or may not also generate images, and an imaging system may generate images or data which are not direct visual images of what is in the field of view thereof. For instance, fiber optics may be used as a conductor of a signal for visualizing, and may not be a transducer or emitter generating further images or data. Imaging instruments, such as intracardiac echocardiography (“ICE”), may be used to generate images which may not necessarily be considered visual images (not visual images representing the appearance such as to the human eye). It will be appreciated that reference is made to either or both a visualization system or an imaging system without intent to limit, reference being made to a visualization/imaging system for the sake of convenience and without intent to limit to either. The principles of the present disclosure are applicable to either system and are not limited to one or the other system. It will further be appreciated that such references are to be understood as including other similar systems known or heretofore known in the art useful for providing information with regard to the position, location, shape, size, geometry, configuration, features, etc. of an implantable device in vivo to facilitate deployment of the device to implant the device at the treatment site. It will further be appreciated that terms such as deploy and implant (and conjugations and other grammatical forms thereof) may be used interchangeably herein with terms such as anchor, affix, fix, secure, couple, engage, hold, retain, etc., (and conjugations and other grammatical forms thereof) without intent to limit.
In accordance with various principles of the present disclosure, a visualization and/or imaging system is delivered and deployed with an implantable device, or with a common delivery component. For instance, a common access sheath or catheter may be configured to deliver both the implantable device as well as the visualization and/or imaging system. Reference is made herein to a delivery/deployment system generically to reference a system used to deliver and/or deploy an implantable device. In some embodiments, a delivery sheath or catheter is used in conjunction with the delivery/deployment system, such as to navigate and/or deliver and/or control the delivery/deployment system. It will be appreciated that the terms sheath, catheter, tubular element, etc., may be used interchangeably herein without intent to limit. The devices, systems, and methods described herein allow bending of sheaths used therewith to occur without kinking or wrinkling to allow unimpeded transport and delivery of the implantable device through tortuous pathways through the body. Various configurations of a flexible sheath or portion or region thereof are within the scope and spirit of the present disclosure, such as described in (but not limited to) U.S. Pat. No. 10,335,275, issued on Jul. 2, 2019.
In some embodiments, the implantable device circumscribes an area (not necessarily circular), and the visualization and/or imaging system is positioned within such circumscribed area. In some embodiments, the visualization and/or imaging system is delivered with the implantable device, such as within such circumscribed area. In some embodiments, the visualization and/or imaging system is extended into such circumscribed area upon (e.g., after) delivery of the implantable device to the treatment site.
In accordance with various further principles of the present disclosure, the position and/or orientation of the visualization and/or imaging system is adjustable relative to the implantable device and/or the treatment site. For instance, in some embodiments the imaging element (e.g., the component of the visualization and/or imaging system receiving images, such as the distal end or tip or free end of a fiber optic, or a transducer of an ultrasound imaging device) is movable with respect to the implantable device. In some embodiments, the imaging element is provided at or along or adjacent or on a flexible elongate member (such as an imaging catheter), at least a portion of the flexible elongate member being movable to move the imaging element with respect to the implantable device and/or implant site. It will be appreciated that terms such as at, along, adjacent, on, etc. are used interchangeably herein to cover specifically “at” as well as immediately adjacent as well as adjacent and spaced apart from and other such terms or spatial relationships. In some embodiments, the imaging element is moved to adjust the distance or spacing between the imaging element and the implantable device and/or the implant site. In some embodiments, the imaging element is moved to adjust the angular position thereof relative to the implantable device and/or the implant site, such as by rotating the imaging element. Additionally or alternatively, in some embodiments, the imaging element is moved to adjust the angular position thereof relative to the implantable device and/or the implant site, such as by adjusting the angle of the imaging element relative to the longitudinal axis of the flexible elongate member delivering or moving the imaging element. For instance, it may be desirable to position an imaging element relative to the implantable device and/or implant site to optimize visualization and/or imaging of the implantable device and/or implant site. In some embodiments, it may be desirable to align an imaging element with (e.g., to be parallel to) a portion of the implant (e.g., a strut or anchor) to enhance visualization and/or imaging. For the sake of convenience, and without intent to limit, reference may be made to the distal end of the flexible elongate member as the portion on which the imaging element is positioned.
In some embodiments, the imaging element is provided on a deflectable or steerable element, such as a flexible elongate member. At least a distal end of the deflectable flexible elongate member may be formed of a flexible material allowing flexing or bending of the flexible elongate member to deflect the imaging element carried by the flexible elongate member to a desired position for imaging an implantable device and/or implant site. It will be appreciated that terms such as deflect, flex, bend, curve, etc., and conjugations and other grammatical forms thereof, may be used interchangeably herein without intent to limit. One or more bends may be made or formed in the flexible elongate member, references to “a” bend being understood as not limited to a single bend. As such, a multidirectional, compound curve is contemplated.
In some embodiments, the flexible elongate member is a deflectable flexible elongate member formed of a shape memory or heat formable material (reference being made to simply shape memory for the sake of convenience and without intent to limit) which is delivered in a substantially straight or extended configuration (such as to facilitate transluminal delivery) and which bends to a deflected configuration once positioned adjacent the implantable device and/or the implant site. More particularly, an end region of the deflectable flexible elongate member carrying an imaging element may be preshaped or preformed from a shape memory material that bends from a generally straight delivery configuration to a deflected configuration, such as transverse to the longitudinal axis of the deflectable flexible elongate member (i.e., the longitudinal axis of the proximally extending portion of the deflectable flexible elongate member). Such bending modifies the position of the imaging element with respect to the longitudinal axis of the deflectable flexible elongate member and with respect to the implantable device and/or implant site. The use of a shape memory material allows such bending to occur without the application of an external force. In other words, the bending occurs generally on its own (automatically) such as a result of internal forces in the material. In some embodiments, a compliant material may be used in conjunction with the shape memory material to facilitate bending of the deflectable flexible elongate member. Generally, the shape memory material overpowers the compliant material (e.g., the compliant material has a lower durometer or is less stiff than the shape memory material) to flex the deflectable flexible elongate member into the desired configuration. Additionally or alternatively, the deflectable flexible elongate member may include an elastomeric material under tension, optionally in combination with a compliant material. It will be appreciated that other suitable materials, such as electroactive polymers or metals to actuate bending or deflection, as known or heretofore known in the art may be used within the scope of the present disclosure.
In some embodiments, a portion of the flexible elongate member (whether or not deflectable on its own accord as described above) is moved by an external force. For example, a steering mechanism may be arranged and configured and coupled with the flexible elongate member, and to steer the flexible elongate member to position the imaging element as desired with respect to the implantable device and/or the implant site. It will be appreciated that terms such as steer, maneuver, navigate, deflect, manipulate, control, etc., and conjugations and other grammatical forms thereof, may be used interchangeably herein without intent to limit. The steering system may bend or simply move (without bending, such as translate laterally) or rotate (e.g., about the longitudinal axis of the deflectable elongate member) the flexible elongate member to a desired position with respect to the implantable device and/or the implant site. It will be appreciated that the flexible elongate member steered by the steering system need not include or be formed of a shape memory material. More particularly, a steering system may steer a flexible elongate member which is deflected upon actuation of the steering system but which does not deflect in a selected direction on its own. Alternatively, a steering system may steer a flexible elongate member which deflects on its own, and which further deflects in a desired direction upon actuation of the steering system.
Various configurations of steering systems are contemplated to facilitate steering of the flexible elongate member to alter the position and/or orientation of the imaging element preferably from a location proximal to the implantation site, such as outside the patient. For instance, one or more pull wires or steering wires (such terms being interchangeable, the term “steering” wire being used herein for the sake of convenience and without intent to limit) may be coupled to the flexible elongate member and extend proximally to a steering handle which may be controllable outside the patient's body (in which the implantable device is being implanted). In some embodiments, a pull ring couples the one or more wires to the flexible elongate member. In some embodiments, the steering handle is rotatable or slidable to move the steering wires to effect movement of the flexible elongate member to adjust the position and/or orientation of the imaging element.
It will be appreciated that a steerable flexible elongate member formed in accordance with various principles of the present disclosure need not be deflectable in the sense that an element or portion or region thereof is formed of a memory material which deflects such element or portion or region without external forces applied thereto (i.e., the element or portion or region as a result of the properties, such as internal forces, of the material). An element or portion or region of a visualization/imaging system formed in accordance with various principles of the present disclosure may be flexible without necessarily moving to a particular configuration on its own. A steering system may be used to adjust the position of such element or portion or region.
In accordance with various principles of the present disclosure, more than one imaging element may be provided. In some embodiments, the more than one imaging elements are positioned at different angular positions with respect to a flexible elongate member carrying the imaging elements. In some embodiments, the more than one imaging elements are positioned at different positions along the longitudinal axis and/or about the circumference of a flexible elongate member carrying the imaging elements. In some embodiments, the position and/or orientation of at least one imaging element is adjustable relative to the implantable device and/or the implant site. In some embodiments, the position and/or orientation of at least one imaging element is adjustable relative to at least another imaging element. In some embodiments, the flexible elongate member carrying the one or more imaging elements is a deflectable elongate member. Such deflectable elongate member may be capable of being deflected to modify the position of at least one imaging element relative to the implantable device and/or the implant site and/or another imaging element. In some embodiments, the deflectable member is formed of a shape memory material which deflects to adjust the position and/or orientation at least one of the imaging elements. In some embodiments, the deflectable elongate member is steerable and optionally includes a shape memory material. In some embodiments, the elongate member is simply flexible without the use of a shape memory material.
In some embodiments, the distal end of the flexible elongate member includes a first distal end carrying a first imaging element and a second distal end carrying a second imaging element. For instance, in some embodiments, the flexible elongate member includes a primary flexible elongate member and a secondary flexible elongate member, such as a dual monorail flexible elongate member. The primary flexible elongate member may be a “mother” flexible elongate member with a lumen through which the secondary flexible elongate member or “child” flexible elongate member is extendable. Either or both flexible elongate members are rotatable to adjust the position and/or orientation of the associated imaging elements with respect to the implantable device and/or the implant site. Either or both flexible elongate members are deflectable and/or steerable. For instance, the primary flexible elongate member may be deflectable so that it deflects upon reaching the desired site. The primary flexible elongate member may additionally or alternatively be steerable. The secondary flexible elongate member generally is longitudinally translatable relative to the primary flexible elongate member and may be deflectable and/or steerable. In some embodiments, the flexible elongate member is bifurcated into a first distal end carrying a first imaging element and a second distal end carrying a second imaging element. Either or both distal ends may be deflectable. In some embodiments, the first distal end extends distally of the second distal end and is deflectable, and the second distal end may be compliant and steerable, but may not deflect upon deployment.
Various principles of the present disclosure may be advantageously applied in delivering and deploying (e.g., position and place) an implantable device or component thereof (such as anchor). Various principles of the present disclosure may further advantageously be applied to adjust the configuration of the implantable device before or during or after implantation, such as to reshape and/or to replace a heart valve annulus. For instance, various principles of the present disclosure are particularly advantageously applied in delivering and deploying an implantable device (such as an annuloplasty device, with or without a replacement valve component) with multiple anchor points (points at which the device is anchored or otherwise secured to tissue). Various principles of the present disclosure are also particularly advantageously applied in delivering and deploying an implantable device which is adjusted or manipulated once secured to tissue, such as to modify the shape, position, configuration, etc. of the tissue. However, it will be appreciated that principles of the present disclosure are applicable to other implantable devices, systems, and methods as well.
It will further be appreciated that various methods of using a device and/or system in accordance with various principles of the present disclosure are disclosed in co-pending U.S. patent application Ser. No. ______, filed concurrently herewith [ATTORNEY DOCKET 2001.2692101], which application is hereby incorporated by reference herein in its entirety for all purposes.
Various embodiments of a visualization and/or imaging system will now be described with reference to examples illustrated in the accompanying drawings. Reference in this specification to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. indicates that one or more particular features, structures, and/or characteristics in accordance with principles of the present disclosure may be included in connection with the embodiment. However, such references do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics, or that an embodiment includes all features, structures, and/or characteristics. Some embodiments may include one or more such features, structures, and/or characteristics, in various combinations thereof. Moreover, references to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. When particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used in connection with other embodiments whether or not explicitly described, unless clearly stated to the contrary. It should further be understood that such features, structures, and/or characteristics may be used or present singly or in various combinations with one another to create alternative embodiments which are considered part of the present disclosure, as it would be too cumbersome to describe all of the numerous possible combinations and subcombinations of features, structures, and/or characteristics. Moreover, various features, structures, and/or characteristics are described which may be exhibited by some embodiments and not by others. Similarly, various features, structures, and/or characteristics or requirements are described which may be features, structures, and/or characteristics or requirements for some embodiments but may not be features, structures, and/or characteristics or requirements for other embodiments. Therefore, the present disclosure is not limited to only the embodiments specifically described herein.
Turning now to the drawings, it will be appreciated that common features are identified by common reference elements and, for the sake of brevity and convenience, and without intent to limit, the descriptions of the common features are generally not repeated. For purposes of clarity, not all components having the same reference number are numbered. Moreover, a group of similar elements may be indicated by a number and letter, and reference may be made generally to one or such elements or such elements as a group by the number alone (without including the letters associated with each similar element). It will be appreciated that, in the following description, elements or components similar among the various illustrated embodiments with reference numbers greater than 1000 are generally designated with the same reference numbers increased by a multiple of 1000 and redundant description is generally omitted for the sake of brevity. Moreover, certain features in one embodiment may be used across different embodiments and are not necessarily individually labeled when appearing in different embodiments.
An example of an embodiment of an implantable device 100 being delivered by a delivery/deployment system 200 to a heart valve annulus VA (e.g., a mitral valve) in accordance with various principles of the present disclosure is illustrated in
It is understood that a variety of different implantable devices may be delivered with a delivery system and methods described herein, only one example of which is illustrated and described herein. The embodiment of an implantable device 100 illustrated herein includes a frame 110 having a generally tubular shape circumscribing an area A, with the visualization/imaging system 1000 positioned within the circumscribed area A. The term “tubular” is to be understood herein to include circular as well as other rounded or otherwise closed shapes. The frame 110 may be configured to change shape, size, dimension, and/or configuration. For example, the frame 110 may assume various shapes, sizes, dimensions, configurations, etc. during different phases of deployment such as during pre-delivery, delivery, tissue engagement, anchoring, cinching, etc. The frame 110 may be formed from one or more struts 112 that may form all or part of the frame 110. The struts 112 may include elongated structural members formed of a metal alloy, a shape memory material, such as an alloy of nickel titanium or other metals, metal alloys, plastics, polymers, composites, other suitable materials, or combinations thereof. In one embodiment, the struts 112 may be formed from the same, monolithic piece of material (e.g., tube stock). Thus, reference to struts 112 may refer to different portions of the same, coextensive component. Alternatively, reference to struts 112 may refer to components that are formed separately and attached together (optionally permanently, such as by welding or other methods). In some embodiments, the struts 112 may be separate components that are detachably coupled to form distal apices 114 (which may alternately be referenced as distal/lower crowns 114) and proximal apices 116 (which may alternately be referenced as proximal/upper crowns 116). Alternatively, if formed from a monolithic piece of material, the material may be cut or otherwise formed to define distal apices 114 and proximal apices 116. The frame 110 carries a plurality of anchors 120 coupled to the distal apices 114 along a lower or distal portion 111 of the frame 110 and extending distally therefrom. Sliders 130 may extend over the proximal apices 116 along the upper or proximal portion 113 of the frame 110. The sliders 130 are slidable over the proximal apices 116 to adjust the relative position of the struts 112 forming the apices 116 to adjust the size, shape, or configuration of the frame 110. It will be appreciated that only some of the distal apices 114, proximal apices 116, struts 112, anchors 120, and sliders 130 are labelled for the sake of simplicity and clarity. The sliders may be referenced or otherwise known as collars or sleeves or cinch sleeves or nuts, and such terms may be used interchangeably herein without intent to limit, reference being made generally to sliders for the sake of convenience.
To adjust the size, shape, or configuration of the frame 110, and/or to anchor and position the implantable device 100, one or more driver shafts 140 may extend through the delivery catheter 310 to be extended from the distal end 311 of the delivery catheter 310 and coupled with the implantable device 100. The term driver shaft may be used interchangeably herein with terms such as driver, driver tube, actuator, etc., without intent to limit. The driver shafts 140 may include driver shafts 140 coupled to the anchors 120 and driver shafts 140 coupled to the sliders 130 in any desired manner known or heretofore known to permit movement (e.g., rotation or translation) of a driver shaft 140 to move a component (e.g., anchor 120 or slider 130) coupled thereto. Movement (e.g., rotation or translation) of driver shafts 140 engaged with the anchors 120 causes the anchors to move (e.g., rotate or translate) relative to the implant site, such as to engage and to penetrate into the tissue at the implant site to cause the frame 110 to be secured to the implant site. The anchors 120 may be advanced singly, one at a time (sequentially or in any desired order), or one or more anchors 120 may be advanced at the same time. Movement (e.g., translation or rotation) of driver shafts 140 engaged with the sliders 130 causes movement (e.g., translation or rotation) of the sliders 130 relative to the apices 116 to which the sliders 130 are coupled to move the orientations of the struts 112 to adjust the size, shape, and configuration of the frame 110. For the sake of simplicity, only the driver shafts 140 coupled to the sliders 130 are illustrated (to avoid the complexity of illustrating driver shafts 140 coupled to the anchors 120). The driver shafts 140 may extend through a delivery lumen 315 defined within the delivery catheter 310. In some embodiments, the delivery catheter 310 is formed with a multi-lumen extrusion 312 defining multiple longitudinally-extending lumens, such as device manipulation lumens 317 (through which the driver shafts 140 for adjusting the anchors 120 and/or the sliders 130 may extend) and/or steering control lumens 319 (through which steering wires described in further detail below may extend).
In the example of an embodiment illustrated in
The visualization/imaging system 1000 may include one or more fiber optics, an ultrasound catheter, an ICE catheter, or any other suitable device capable of transmitting an image to the operator of the delivery/deployment system 200 to facilitate delivery and/or deployment of the implantable device 100. Fiber optics may simply transmit visual signals or may replace wires carrying ultrasound signals to an imaging device for viewing by a medical professional. The visualization/imaging system 1000 may include a flexible elongate member 1010 and one or more transducers or imaging elements 1020 provided on or along a distal end 1011 of the flexible elongate member 1010. The imaging elements 1020 may be one or more linear imaging elements 1020 or one or more phased arrays of imaging elements 1020. Generally, a phased array of imaging elements 1020 is smaller and may be preferable for certain applications/environments. The one or more imaging elements 1020 may be arranged longitudinally along the longitudinal axis LA of the flexible elongate member 1010, and may include longitudinally spaced apart imaging elements 1020. Additionally or alternatively, the imaging elements 1020 may be arranged circumferentially about the perimeter of the flexible elongate member 1010, and may include circumferentially spaced apart imaging elements 1020. In some embodiments, rotation of the visualization/imaging system 1000 around the inside of the valve annulus, allows viewing of the relative position of the frame 110, and the implant site, such as the heart valve annulus, and/or any of the valve leaflets, for accurate positioning of the device and anchors 120 thereof relative to (e.g., around and above) the valve annulus VA. An indexing feature (not shown) on the visualization/imaging system 1000 may be provided such that actuation of the indexing feature causes the visualization/imaging system 1000 to move (e.g, rotate), optionally automatically, to the next position (such as from one anchor position to another anchor position).
The visualization/imaging system 1000 may thus be configured to generate/transmit a radial image, such as to position the one or more anchors 120 for insertion into a heart valve annulus VA, and/or a circumferential image, such as to position the frame 110 in a plane above the heart valve annulus VA and its leaflets. It will be appreciated that the devices and features shown and described herein may be used to deliver various other implantable devices, such as other resizing devices or heart valve replacement valves.
In some embodiments, software or electronic controls can be effective to cycle through the radial cross sectional images around the valve annulus perimeter, relieving the need to physically move (e.g., via rotation, translation, or deflection) the visualization/imaging system 1000. A larger circumferential transducer array or imaging element array could also be placed distal of the annulus to not interfere with space limitations of the delivery catheter 310, further decreasing the profile of the delivery catheter 310. In another embodiment, the visualization/imaging system 1000 may generate a three dimensional image of the heart valve annulus VA and/or of the frame 110. The medical professional may then more readily see the relative alignment of the valve annulus, valve leaflets, and the implant device 100 (such as anchor points, e.g., anchor 120, thereof).
In accordance with various principles of the present disclosure, the flexible elongate member 1010 of a visualization/imaging system 1000 formed in accordance with various principles of the present disclosure may be sufficiently flexible to allow bending of the distal end 1011 thereof to adjust the position of the one or more imaging elements 1020 carried by the flexible elongate member 1010 relative to the implantable device 100 and/or the implant site. The resulting increased visualization may be used to verify the positioning of an anchor with respect to the heart valve annulus VA, the condition of the tissue of the heart valve V, the depth of insertion of an anchor, etc. In some embodiments, at least a portion of the distal end 1011 of the flexible elongate member 1010 is formed of a shape memory material causing the distal end 1011 to deflect to a preset configuration upon exiting the delivery lumen 315 of the delivery catheter 310. Such movement of the distal end 1011 of the flexible elongate member 1010 without external forces (i.e., movement caused by the internal forces of the material of the element itself) may be considered to form a self-deflecting, or, more simply, a deflectable visualization/imaging system 1000. Additionally or alternatively, in some embodiments, the flexible elongate member 1010 is steerable by a steering system (e.g., including a mechanism separately formed from the flexible elongate member 1010 to control or otherwise affect movement thereof). A steerable flexible elongate member 1010 optionally includes a shape memory material as well (to be deflectable), though need not include such material. A deflectable flexible elongate member 1010 formed at least in part from a shape memory material may include a compliant material positioned to facilitate flexing of the flexible elongate member 1010, but without itself necessarily moving or returning the flexible elongate member 1010 to a pre-selected/predetermined configuration. Various examples of embodiments and configurations of deflectable and/or steerable visualization/imaging systems will now be described with reference to
In the example of an embodiment illustrated in
To adjust the view of the visualization/imaging system 2000 relative to the implantable device 100 and/or the heart valve annulus VA, the deflectable flexible elongate member 2010 may be moved, such as rotated (such as generally described above) or shifted laterally. As illustrated in
In accordance with various principles of the present disclosure, as noted above, a visualization/imaging system may include one or more imaging elements for visualizing or imaging an implantable device and/or implant site. A deflectable visualization/imaging system 2000 such as illustrated in
Additionally or alternatively, a visualization/imaging system formed in accordance with various principles of the present disclosure may include two or more imaging elements longitudinally spaced apart from one another. For instance, in the example of an embodiment illustrated in
As noted above, a visualization/imaging system formed in accordance with various principles of the present disclosure may be steerable in addition to or instead of being deflectable on its own accord (e.g., formed from a shape memory material to be self-deflecting without external forces). Any of a variety of steering systems such as described in further detail below may be used to steer a flexible elongate member of a visualization/imaging system formed in accordance with various principles of the present disclosure. It will be appreciated that, as described above, one or more imaging elements may be provided along the distal end of the flexible elongate member, such as longitudinally or circumferentially with respect to one another, and optionally spaced apart from one another.
An example of an embodiment of a steerable visualization/imaging system 4000 is illustrated in
In accordance with various principles of the present disclosure, more than one imaging element may be provided on a distal end of a visualization/imaging system by being provided on more than one distal end of the visualization/imaging system. More particularly, the visualization/imaging system may have more than one distal end, each distal end carrying one or more imaging elements. The distal ends may be movable independently of or together with one another to vary the viewable area of the visualization/imaging system (e.g., the imaging elements thereof) relative to the implantable device 100 and/or the heart valve annulus VA. One or more of the distal ends may be deflectable and/or steerable. Examples of visualization/imaging systems with more than one distal end are illustrated in
In the example of an embodiment illustrated in
In the example of an embodiment illustrated in
The above-described steering of a visualization/imaging system formed in accordance with various principles of the present disclosure may be achieved by any of a variety of known or heretofore known steering systems The steering system preferably allows the visualization/imaging system to be maneuvered as desired from a convenient location proximal to the implantable device, and preferably outside the patient. The steering system may be controlled manually or automatically (such as computer-controlled). Embodiments are not limited in this context. Various examples of steering systems which may be used to steer a flexible elongate member (and particularly the distal end thereof) of a visualization/imaging system formed in accordance with various principles of the present disclosure will now be described with reference to
An example of an embodiment of a visualization/imaging system 1000 with a steering system 1100 having a rotatable controller 1110 is illustrated in
In the examples of embodiments illustrated in
Rotation of the controller 1110 in a first rotational direction R1, as illustrated in
A rotatable controller 1110, as in the examples of embodiments illustrated in
It will be appreciated that steering systems formed in accordance with various principles of the present disclosure may include any of a variety of other types of controllers. For example, instead of having a controller which rotates about a rotational axis substantially parallel to the longitudinal axis LA of the steerable flexible elongate member 1010, a steering system controller may be rotatable about a rotational axis RA transverse to (e.g., perpendicular to) the longitudinal axis LA of the steerable flexible elongate member 1010. For instance, in the example of an embodiment of a steering system 3100 illustrated in
Another example of an embodiment of a steering system 4100 with a rotatable controller 4110 actuated by rotating about a rotational axis RA transverse to the longitudinal axis LA of the steerable flexible elongate member 1010 is illustrated in
As an alternative to a rotatable controller, as in the examples of embodiments illustrated in
As may be appreciated, the ability of a visualization/imaging system 1000 to be moved with respect to an implantable device 100 in accordance with any one or more of the various principles of the present disclosure described herein increasing the visualization/imaging field of the visualization/imaging system 1000. Improved or enhanced visualization/imaging may be used to verify the positioning of an anchor with respect to the heart valve annulus VA, the condition of the tissue of the heart valve VA, the depth of insertion of an anchor, etc., and thus facilitates proper placement and anchoring of the implantable device 100 in manners not as readily achievable previously.
Various additional features of an implantable device as illustrated herein, as well as related delivery systems and methods of use may be appreciated with reference to the following patents and patent applications, each of which is incorporated herein by reference in its entirety for all purposes: U.S. Pat. No. 9,180,005, issued Nov. 10, 2015, and titled “ADJUSTABLE ENDOLUMINAL MITRAL VALVE RING”; U.S. Pat. No. 10,335,275, issued Jul. 2, 2019, and titled “METHODS FOR DELIVERY OF HEART VALVE DEVICES USING INTRAVASCULAR ULTRASOUND IMAGING”; U.S. Pat. No. 9,848,983, issued Dec. 26, 2017, and titled “VALVE REPLACEMENT USING ROTATIONAL ANCHORS”; U.S. Pat. No. 10,555,813, issued Feb. 11, 2020, and titled “IMPLANTABLE DEVICE AND DELIVERY SYSTEM FOR RESHAPING A HEART VALVE ANNULUS”; U.S. Pat. No. 10,548,731, issued Feb. 4, 2020, and titled “IMPLANTABLE DEVICE AND DELIVERY SYSTEM FOR RESHAPING A HEART VALVE ANNULUS”; U.S. Pat. No. 9,192,471, issued Nov. 24, 2015, and titled “DEVICE FOR TRANSLUMENAL RESHAPING OF A MITRAL VALVE ANNULUS”; U.S. Patent Application Publication No. 2010/0249920, published Sep. 30, 2010, and titled “DEVICE FOR TRANSLUMENAL RESHAPING OF A MITRAL VALVE ANNULUS”; U.S. Pat. No. 9,795,480, issued Oct. 24, 2017, and titled “RECONFIGURING TISSUE FEATURES OF A HEART ANNULUS”; U.S. Pat. No. 9,610,156, issued Apr. 4, 2017, and titled “MITRAL VALVE INVERSION PROSTHESES”; U.S. Pat. No. 10,321,999, issued Jun. 18, 2019, and titled “SYSTEMS AND METHODS FOR RESHAPING A HEART VALVE”; U.S. Patent Application Publication No. 2020/0022811, published Jan. 23, 2020; and/or U.S. Patent Application Publication No. 2020/0121461, published Apr. 23, 2020.
Although embodiments of the present disclosure may be described with specific reference to an implantable device for use with mitral valves, it is appreciated that various other implantable devices may similarly benefit from the devices, systems, and methods disclosed herein.
Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the disclosure is not intended to be limited to the implementations shown herein, but is to be accorded the widest scope consistent with the claims, the principles and the novel features disclosed herein. The word “example” is used exclusively herein to mean “serving as an example, instance, or illustration.” Any implementation described herein as “example” is not necessarily to be construed as preferred or advantageous over other implementations, unless otherwise stated.
Certain features that are described in this specification in the context of separate implementations also can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation also can be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features can be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination can be directed to a sub-combination or variation of a sub-combination.
Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Additionally, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.
In view of the above, it should be understood that the various embodiments illustrated in the figures have several separate and independent features, which each, at least alone, has unique benefits which are desirable for, yet not critical to, the presently disclosed devices, systems, and methods. Therefore, the various separate features described herein need not all be present in order to achieve at least some of the desired characteristics and/or benefits described herein. Only one of the various features described herein may be present in an embodiment in accordance with various principles of the present disclosure. Alternatively, one or more of the features described with reference to one embodiment can be combined with one or more of the features of any of the other embodiments provided herein. That is, any of the features described herein can be mixed and matched to create hybrid designs, and such hybrid designs are within the scope of the present disclosure. Moreover, throughout the present disclosure, reference numbers are used to indicate a generic element or feature of the disclosed embodiment. The same reference number may be used to indicate elements or features that are not identical in form, shape, structure, etc., yet which provide similar functions or benefits. Additional reference characters (such as letters, as opposed to numbers) may be used to differentiate similar elements or features from one another.
All apparatuses and methods discussed herein are examples of apparatuses and/or methods implemented in accordance with one or more principles of this disclosure. These examples are not the only way to implement these principles but are merely examples, not intended as limiting the broader aspects of the present disclosure. Thus, references to elements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure.
The foregoing discussion has broad application and has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be clear to those skilled in the art that principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the concept, spirit, or scope, or characteristics thereof. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of the certain aspects, embodiments, or configurations of the disclosure may be combined in alternate aspects, embodiments, or configurations. While the disclosure is presented in terms of embodiments, it should be appreciated that the various separate features of the present subject matter need not all be present in order to achieve at least some of the desired characteristics and/or benefits of the present subject matter or such individual features. One skilled in the art will appreciate that the disclosure may be used with many modifications or modifications of structure, arrangement, proportions, materials, components, and otherwise, used in the practice of the disclosure, which are particularly adapted to specific environments and operative requirements without departing from the principles or spirit or scope of the present disclosure. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of elements may be reversed or otherwise varied, the size or dimensions of the elements may be varied. Similarly, while operations or actions or procedures are described in a particular order, this should not be understood as requiring such particular order, or that all operations or actions or procedures are to be performed, to achieve desirable results. Additionally, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims, and not limited to the foregoing description or particular embodiments or arrangements described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and can be claimed separately or in combination with features of that embodiment or any other embodiment, the scope of the subject matter being indicated by the appended claims, and not limited to the foregoing description.
In the foregoing description and the following claims, the following will be appreciated. The phrases “at least one”, “one or more”, and “and/or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a”, “an”, “the”, “first”, “second”, etc., do not preclude a plurality. For example, the term “a” or “an” entity, as used herein, refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and/or the like) are only used for identification purposes to aid the reader's understanding of the present disclosure, and/or serve to distinguish regions of the associated elements from one another, and do not limit the associated element, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority, but are used to distinguish one feature from another.
The following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term “comprises/comprising” does not exclude the presence of other elements or steps. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.
This application claims the benefit of priority of U.S. Provisional Application No. 63/193,236, filed May 26, 2021, the entire disclosure is incorporated herein for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63193236 | May 2021 | US |
