Patent Application
20210154014
The present disclosure relates generally to the field of implantable medical devices and more particularly to implantable devices, systems, and methods for adjusting heart features.
Mitral regurgitation (MR) (also referred to as mitral insufficiency, or mitral incompetence) is a form of valvular heart disease in which the leaflets of the mitral valve fail to properly coapt, or close. When the mitral valve does not close properly, blood may be regurgitated; e.g. flow backwards from the left ventricle to the left atrium, leading to cardiac deformation wherein the mitral annulus and/or chambers of the heart may thicken and/or become enlarged, further exacerbating regurgitation. Atrial fibrillation, congestive heart failure, cardiogenic shock, and other adverse events may occur as a result.
Mitral valve repair may include a combination of annular and sub-valvular procedures intended to restore the physiological form and function of the mitral valve. For example, annuloplasty procedures may involve surgically implanting a ring around the mitral annulus to restore a diameter of the patient's mitral annulus to that of a healthy state where the valve leaflets properly coapt and mitral regurgitate flow is minimized. Additionally, sub-valvular repair procedures such as repositioning of papillary muscles or repairing chordae within the left ventricle may be performed.
Due to the invasive nature of the surgical approaches to mitral valve repair, several transcatheter techniques have been developed to emulate surgical approaches. Because delivery catheters that carry mitral valve or sub-valvular components may extend up to 52″ in length, it can be challenging to transport and accurately place repair components at a treatment site.
According to one aspect, a delivery system includes a visualization catheter including a proximal end, a distal end, and an elongate tubular body extending from the proximal end to the distal end of the visualization catheter, the visualization catheter including an imaging device coupled to a distal portion of the visualization catheter. An anchor lumen extends from the proximal end of the visualization catheter through an anchor port disposed on a distal wall of the visualization catheter. The delivery system includes an adjustment mechanism, translatably disposed within a lumen of the visualization catheter, the adjustment mechanism configured to align the anchor port with a tissue target based on feedback provided by the imaging device.
In various embodiments, the imaging device includes an ultrasound transducer. In one embodiment, the adjustment mechanism includes a distal anchor. The delivery system may further include a retention mechanism, disposed about the visualization catheter, the retention mechanism including a linear configuration where the retention mechanism may be flush with the visualization catheter and an expanded configuration where the retention mechanism extends radially from the visualization catheter towards cardiac tissue. In some embodiments, the retention mechanism may include a balloon, and the balloon may be coupled to an inflation lumen of the visualization catheter. In some embodiments, the retention mechanism may include a plurality of expandable splines. In some embodiments, the retention mechanism may include an expandable stent. In various embodiments, the retention mechanism may be disposed proximate to or about at least a portion of the imaging device. In some embodiments, the delivery system may further include a needle, translatably disposed within the anchor lumen, the needle including a sharpened distal tip and having a needle lumen extending therethrough, an anchor delivery catheter, translatably disposed within the needle lumen, an anchor, disposed within the anchor delivery catheter and a push rod, translatably disposed within the anchor delivery catheter proximally of the anchor, the push rod configured to advance the anchor through the distal end of the anchor delivery catheter into the tissue target. In some embodiments, the anchor may be one of a plurality of anchors, disposed within the anchor lumen, where each anchor may be coupled to a distal end of one of a plurality of sutures, the proximal end of the sutures extending proximally through the anchor lumen, where the visualization catheter is rotatable about the adjustment mechanism to direct the anchor port towards a plurality of different tissue targets to embed the plurality of anchors within the different tissue targets, and where the delivery system includes a clamping mechanism, translatably disposed within a working channel of the visualization catheter, the clamping mechanism configured to join at least two of the plurality of sutures.
According to another embodiment, a system for delivering repair components to a cardiac cavity includes a visualization catheter including a proximal end, a distal end, and an elongate tubular body extending from the proximal end to the distal end of the visualization catheter, the visualization catheter including an imaging device coupled to a distal portion of the visualization catheter. The system includes at least one stabilization mechanism for positioning a distal end of the visualization catheter within the cardiac cavity and an anchor delivery system, disposed within an anchor lumen of the visualization catheter. In some embodiments, the anchor lumen extends from the proximal end of the visualization catheter through an anchor port disposed on a distal wall of the visualization catheter and the anchor delivery system includes a hollow needle, translatably disposed within the anchor lumen. The anchor delivery system includes an anchor delivery catheter, translatably disposed within the hollow needle, and an anchor having a sharpened distal end and a proximal coupler coupled to a suture, the anchor translatably disposed within the anchor delivery catheter. The system also includes an actuator configured to expel the anchor from the anchor delivery catheter to embed the anchor into tissue.
In various embodiments, the visualization catheter further includes a working channel and a clamp tool disposed within the working channel. The stabilization mechanism may include a retention mechanism such as a balloon, a spline, a stent or a combination thereof. In some embodiments, the retention mechanism includes a linear configuration where the retention mechanism lies flush against an external surface of the visualization catheter and an expanded configuration where at least a portion of the retention mechanism extends radially from the external surface of the visualization catheter. In some embodiments, the stabilization mechanism includes a depth adjustment mechanism, translatably disposed within a lumen of the visualization catheter and configured to extend distally of the visualization catheter to control a depth of the anchor port.
In some embodiments, the anchor lumen may be one of a plurality of anchor lumens, each anchor lumen of the plurality of anchor lumens extending from one of a plurality of ports disposed on the distal portion of the visualization catheter to the proximal end of the visualization catheter. The plurality of ports may include at least two ports disposed along a common longitudinal path or along different longitudinal paths or both. In some embodiments, the system further includes a radio opaque marker disposed upon the distal portion of the visualization catheter or the hollow needle or the anchor delivery catheter or a combination thereof.
According to another aspect, a method of papillary approximation includes advancing a distal portion of a visualization catheter into a heart chamber, the visualization catheter including a stabilization mechanism disposed within a lumen and activating the stabilization mechanism to secure the distal portion of the visualization catheter within the heart chamber. The method includes imaging the heart chamber to identify a first tissue target and adjusting the stabilization mechanism to align a port extending through a wall of the distal portion of the visualization catheter with the first tissue target. The method includes advancing a hollow needle through the port into the first tissue target and forwarding a first anchor through the hollow needle into the first tissue target, the first anchor coupled at a proximal end to a first suture. The method includes rotating the visualization catheter, imaging the heart chamber to identify a second tissue target and advancing the hollow needle through the port into the second tissue target. The method includes forwarding a second anchor through the hollow needle into the second tissue target, the second anchor coupled at a proximal end to a second suture, pulling together the first suture and the second suture to pull the first anchor and first tissue target towards the second anchor and second tissue target to provide a modified heart chamber configuration and clamping the first suture to the second suture to retain the modified heart chamber configuration.
In various embodiments, the port is one of a plurality of ports disposed along and through the distal portion of the visualization catheter, and advancing the hollow needle into the first tissue target and advancing the hollow needle into the second tissue target uses different ones of the plurality of ports. In other embodiments, the first anchor may be one of a first pair of anchors, the second anchor may be one of a second pair of anchors, and the method includes forwarding the first pair of anchors through a pair of ports into the first tissue target, rotating the visualization catheter and forwarding the second pair of anchors through the pair of ports into the second tissue target. With such an arrangement, an implant and method of delivery is disclosed which enables non-invasive accurate placement of sub-valvular repair components.
Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying figures, which are schematic and not intended to be drawn to scale. In the figures, each identical or nearly identical illustrated component is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. In the figures:
A device, system, and method enabling sub-valvular repair of papillary and/or other myocardial structure to an approximately healthy configuration is described herein. For example, such a device, system, and method may be used when mitral valve regurgitation (MR) enlarges the chambers of the heart, displacing papillary muscles and impairing the function of the mitral valve. According to one embodiment a system for controlled delivery of sub-valvular restructuring components includes a visualization catheter supporting an imaging device, such as an ultrasound transducer, that may be used to visualize sub-valvular placement of anchors to improve restructuring accuracy. The visualization catheter may include one or more anchor lumens, extending from a proximal end of the visualization catheter through a port disposed on a distal wall of the visualization catheter, proximate to the imaging device. The imaging device may be used to identify a tissue target, for example in the papillary muscles, ventricle wall, and/or other myocardial tissue, and to guide the deployment of the anchor into the tissue target with increased accuracy. In some embodiments, the visualization catheter may also include one or more stabilization mechanisms that secure the visualization catheter within the heart chamber during anchor deployment. The stabilization mechanism may include, for example, a depth adjustment mechanism, which can be controlled to align the port of the visualization catheter with one or more tissue targets. The ability to control the depth of anchor placement using such an alignment mechanism may reduce vector offsets between pairs of deployed anchors, thereby increasing anchoring accuracy and producing a more natural structure. In some embodiments, the stabilization mechanism may include a retention mechanism. The retention mechanism may include an expandable member that may be disposed about the distal portion of the visualization catheter and may act to anchor the distal portion of the visualization catheter between tissue structures of the ventricle. The retention mechanism may also serve to reduce entanglement with the chordae tendinea and other structures within the ventricle.
These and other beneficial aspects of a system for sub-valvular repair are described in more detail below. It should be noted that, although embodiments of the present disclosure may be described with specific reference to papillary muscles, the principles disclosed herein may be readily adapted to benefit any other dilatation, valve incompetency, valve leakage, and other similar heart failure conditions.
As used herein, the term “distal” refers to the end farthest away from the medical professional when introducing a medical device into a patient, while the term “proximal” refers to the end closest to the medical professional when introducing a medical device into a patient.
In a diseased heart, one or more of the chordae tendineae 132a, 132b may be stretched or ruptured, resulting in a flailing leaflet 122a, 122b that no longer effectively closes, resulting in regurgitation. The papillary muscles 134a, 134b may become spaced apart, for example due to enlargement of the heart. Alternatively, or in conjunction, the mitral annulus 115 may become stretched or deformed, and the valves may also fail to close as a result.
To repair the heart failure condition, repair components may be transluminally deployed to the heart 100. In
In one embodiment, the delivery system 150 may include a plurality of nested catheters including a visualization catheter 160 having a steerable distal end 155 to facilitate navigation of repair components into the left ventricle. In some embodiments, initial delivery of the system 150 may be performed with assistance of a guidewire 156, which may be translatably disposed within a working channel of the visualization catheter 160. According to one aspect, as described in more detail below, the visualization catheter 160 comprises an elongate, generally tubular body having a plurality of lumens extending at least partially from a proximal end to a distal end, and an imaging device 170 disposed proximate to its the distal end. The visualization catheter may also include one or more ports, such as port 180, extending through a wall in the distal portion of the visualization catheter into an anchor lumen that extends through the visualization catheter. In the illustrated embodiment, the ports 180 are shown disposed about the imaging device 170 although the disclosure is not so limited. For example, in other embodiments, the ports may all be disposed proximal or distal to the imaging device 170. As described below, anchors may be driven through the anchor lumen(s) of the visualization catheter, out of the ports and into heart tissue.
In some embodiments, the elongate body 210 of the visualization catheter 160 may comprise a composite of layers of thermoplastic elastomer (TPE), for example PEBAX provided by ARKEMA corporation of Colombes France. Alternatively, nylon, polyurethanes, polyester, silicone, or other similar materials may be used to provide thin walls that may be extruded and layered over braided wires or coils for tensile and hoop strength, although the disclosed system is not limited to any particular material composition. In some embodiments, the length of the visualization catheter 160 may range from between 24″-52″, and more particularly between 42″-46″.
The visualization catheter 160 is shown to include an imaging device 170 disposed proximate to its distal end. The imaging device 170 may comprise, for example, an ultrasound transducer. The ultrasound transducer may be directly coupled to the visualization catheter, for example, attached to an external surface or formed at least partially within the visualization catheter. Alternatively, the ultrasound transducer may be indirectly coupled to the visualization catheter, for example coupled to or disposed upon a stabilization mechanism, adjustment mechanism and/or retention mechanism of the visualization catheter as described in more detail below. In some embodiments, the ultrasound transducer may be introduced through a channel of the visualization catheter towards the distal end to enable visualization during sub-valvular repair.
The imaging device may operate using any number of scanning modes, including electronic curved linear array, forward-viewing, electronic curved linear array, electronic 360° radial array, mechanical radial, and/or mechanical helical for dual plane reconstruction (DPR). Other ultrasound imaging methods may be substituted herein by those of skill in the art and are considered to be within the scope of this disclosure.
Although one imaging device 170 is shown, in some embodiments multiple imaging devices, such as ultrasound transducers, may be used to enable 3D imaging of the heart cavity. In some embodiments, multiple different types of imaging sensors may be disposed on, within or proximate to the distal end of the visualization catheter, and the image data may be combined to provide an anatomical map with increased detail and complexity. Such imaging devices include, but are not limited to, biopotential or impedance sensors, electromagnetic sensors, intracardiac echocardiography (ICE) imaging sensors, etc. For example, if a 6 degree-of-freedom electromagnetic sensor is incorporated into the catheter, if also coupled with a pre-operative scan such as CT or MR, the catheter position and orientation may be tracked relative to anatomical features as the catheter is advanced and positioned in the heart. When positioned in the heart near expected anatomical landmarks such as the papillary muscle, the ultrasound sensor may be activated, providing real-time anatomical information. All data sources may be combined or fused to provide increased detail and accuracy for positioning of anchors.
In one embodiment the visualization catheter 160 includes one or more stabilization mechanisms which operate to retain the visualization catheter in a relatively consistent position and orientation within the ventricle during sub-valvular reconstruction. For example, a depth adjustment mechanism 175 is translatably disposed within a lumen of the visualization catheter 160. In one embodiment, the depth adjustment mechanism 175 is configured for distal advancement past the distal end 205 of the visualization catheter 160, to enable the distal end 174 of the depth adjustment mechanism 175 to contact the apex (or other interior surface of the heart), to adjust the height of the ports 180 within the heart chamber. Thus, the depth adjustment mechanism 175 may be used to align the ports 180 with target tissue within the heart for anchoring purposes.
In some embodiments, the distal end 174 of the depth adjustment mechanism 175 may include an anchor 176, to further secure the catheter 160 within the heart chamber. Other methods of securing the depth adjustment, such as suction or the like, are considered within the scope of this disclosure. In some embodiments, the distal end 174 may be formed of or include a flexible material and/or a cushion, configured to control the interaction of the anchor with the heart features to reduce risks of perforation or other damage to cardiac tissue.
In some embodiments, once ports are aligned with target tissue, the position of the depth adjustment mechanism may be locked (for example, using a clamp, threaded collar, etc.) by a lock mechanism (not shown) at the proximal end of the visualization catheter. One advantage provided by the depth adjustment mechanism is that it enables radial deployment of anchors through a common port to align along an axis perpendicular to the visualization catheter. For example, a first anchor may be deployed through a port, the visualization catheter may be rotated, and a second anchor may be deployed through the same port. By maintaining the same depth adjustment for each deployed anchor, the anchors may be aligned along a common circumference, minimizing vector offsets that could reduce the efficacy of the sub-valvular repair procedure.
In some embodiments, a distal end of the depth adjustment mechanism 175 may include one or more markers, such as markers 179 which may be formed, for example, from metal, calcium or other material that is visible via ultrasound for example echogenic coatings or textured surfaces that reflect under echo, such as the Sono-coat™ coating provided by Encapson BV of Institutenweg, Enschede, The Netherlands, or other suppliers of echogenic coatings. Such markers may be used, for example, to provide information to the surgeon regarding the height of the ports. Alternatively, or in addition, markings may be provided proximate to, around or partially around ports 180 to further assist with alignment of the ports with tissue targets.
In one embodiment, the stabilization mechanisms of the visualization catheter 160 may also include a retention mechanism 190, such as the balloon illustrated in
An anchor delivery system may be used to forward an anchor through an anchor lumen of the visualization catheter 160 and out of a port 180 into target tissue, under visualization using the ultrasound imaging device 170. One such anchor delivery system 300 is shown in cross section in
A method for using the embodiment of the delivery system as described above for sub-valvular repair will now be described with regard to
In
Referring briefly to
In
Referring now to
In some embodiments, as described above, the visualization catheter may include multiple ports distributed longitudinally along the distal portion of the visualization catheter. Providing multiple ports may allow deployment of multiple parallel cinching structures that may improve the integrity of cardiac restructuring, although the present disclosure is not so limited.
By way of example, In
As shown in
Although
Various embodiments of the disclosed system for delivery of sub-valvular repair components have included a balloon-based retention mechanism, although it is appreciated that various alternative methods for retention mechanisms may be substituted herein by one of skill in the art. For example,
Accordingly, a system and method for sub-valvular repair has been shown and described. 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 an “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.
It will be understood by those within the art that, in general, terms used herein are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”
The devices and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While various embodiments of the devices and methods of this disclosure have been described, it may be apparent to those of skill in the art that variations can be applied to the devices and/or methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosure as defined by the appended claims.
The present application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application 62/941,006, filed Nov. 27, 2019, which application is incorporated herein by reference in its entirety for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 62941006 | Nov 2019 | US |
