Patent Grant
11938022
The heart pumps blood through the body via blood vessels of the circulatory system. The pumped blood carries oxygen and nutrients to the body, and carries metabolic waste, such as carbon dioxide, to the lungs. The heart includes four distinct chambers. The right side of the heart includes the right atrium and the right ventricle, and is responsible for receiving de-oxygenated blood from the body, and then pumping the de-oxygenated blood to the lungs in order to oxygenate the blood. The left side of the heart includes the left atrium and left ventricle, and is responsible for receiving oxygenated blood from the lungs, and then pumping the oxygenated blood to various parts of the body. Four valves regulate the movement of blood within the chambers of the heart: the aortic valve, the mitral valve, the pulmonic valve, and the tricuspid valve. These valves open and close repeatedly, and therefore, can be subject to wear and tear and other challenges that affect their performance.
Indeed, heart valve diseases affect approximately 300,000 people worldwide each year. Those diseases may include abnormal leaflet tissue, for example, excess tissue growth, tissue degradation/rupture, or tissue hardening/calcifying. Those diseases may also include abnormal tissue position through the cardiac cycle of the heart, for example, annular dilation or ventricular reshaping (e.g., valve prolapse). Such abnormal leaflet tissue and abnormal tissue position may lead to degradation in valve function including leakage/blood backflow (valve insufficiency and regurgitation) or a resistance to blood forward flow (valve stenosis).
A valve treatment procedure is an invasive or minimally invasive surgical or interventional procedure in which a patient's defective heart valve is repaired or replaced. Thus, the abnormal leaflet tissue or the abnormal tissue position may be repaired in order to restore operability of the heart valve. In a valve replacement procedure, a valve prosthesis is delivered to the patient's native heart valve without removing the patient's native heart valve. Instead, the valve prosthesis replaces the functions of the native heart valve so as to regulate blood flow through the chambers of the heart. The valve prosthesis should be implanted in a manner that avoids obstructing blood flow or disrupting the natural flow path and natural hemodynamics.
Disclosed herein are a transcatheter valve prosthesis and a method for implanting the prosthesis in a heart of a patient. The prosthesis includes a tubular body coupled to a prosthetic valve. A fabric may be disposed on an outer surface of the tubular body.
The method includes partially deploying the tubular body from a catheter to a position distal of a distal edge of a native valve leaflet, and moving the catheter such that the deployed outflow end portion of the tubular body engages the distal edge of the native valve leaflet and lifts the native valve leaflet in the proximal direction towards an atrial chamber of the heart. Then, the tubular body can be fully deployed such that the native valve leaflet is captured between the outflow end portion and the inflow end portion.
In the drawings, like reference characters generally refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments are described with reference to the following drawings, in which:
The following detailed description refers to the accompanying drawings that show, by way of illustration, specific details in which the disclosed embodiments may be practiced. Other embodiments may be utilized and structural and logical changes may be made without departing from the scope of the present disclosure. The various embodiments are not necessarily mutually exclusive, as some aspects of embodiments can be combined with one or more aspects of other embodiments to form additional embodiments.
The prosthesis and methods of implantation described herein are for functional replacement of a native atrioventricular heart valve 5, such as a native mitral valve or tricuspid valve, connecting an atrial chamber 15 with a ventricular chamber 10 (see
In addition to functional replacement of the native valve, the disclosed prostheses and methods are designed to reduce the likelihood of partial or complete obstruction of blood flow through the left ventricular outflow tract (LVOT) or right ventricular outflow tract (RVOT). For instance, the disclosed prosthesis and methods can reduce the risk of partial or complete obstruction of blood flow from the left ventricle to the aorta or from the right ventricle to the pulmonary artery.
In transcatheter valve replacement (e.g., of the native mitral or tricuspid valve), some patients are currently screened out and are not eligible to the treatment because of the increased or prohibitive risk of obstruction of the LVOT or RVOT by the ventricular part of prosthesis (e.g., the outflow end portion). After implantation of a mitral or tricuspid valve, blood should flow from the atrial chamber (e.g., left or right atrium) through the valve to the ventricular chamber (e.g., left or right ventricle) and out through the aortic valve or pulmonic valve without obstruction. However, in some patients, blood flows from the atrial chamber through the valve, but is obstructed from flowing from the ventricular chamber to the aorta or pulmonary artery by the outflow end of a fabric-covered tubular body forming part of the prosthesis and/or is obstructed by the native valve leaflet (e.g., anterior valve leaflet). Risk factors for obstruction of the LVOT or RVOT may be related to the anatomy of the patient's native heart tissue. For example, such risk factors include septal hypertrophy or bulge, small left or right ventricular cavity size, and anterior leaflet angle or length.
The prostheses and implantation methods disclosed herein are designed to reduce the likelihood of partially or completely obstructing blood flow through the LVOT or RVOT. Even though some portions of the prosthesis (e.g., outflow end portion) are designed to be implanted in the ventricular chamber of the heart, the sub-annular or ventricular portion of the prosthesis is designed to permit blood flow there through. Additionally, the implantation methods disclosed herein are designed to lift the native valve leaflets to avoid obstruction by the native leaflets covering a sub-annular portion of the prosthesis. In some embodiments, the patient treated by the disclosed prosthesis and implantation method is at risk of obstruction of a left ventricular outflow tract or a right ventricular outflow tract by the anterior mitral valve leaflet or the anterior or septal tricuspid valve leaflet.
When implanted, the tubular body 30 may be disposed in the interior of the native heart valve 5 (see
The tubular body 30 is coupled to a prosthetic heart valve 40 such that the valve 40 is arranged within a central lumen 34 of the tubular body 30, as shown in
The tubular body 30 may be formed of a mesh-like structure, which can be delivered within a patient via a delivery catheter 60 inserted over the antegrade route (trans-septal or trans-atrial delivery for the mitral valve, or superior/inferior vena cava delivery for the tricuspid valve) or over the retrograde route (trans-apical or through the aortic/pulmonic valve) (see
As shown in
The tubular body 30 may be generally cylindrical in shape. As shown in
The outer diameter of the inflow end portion 301 may increase along a direction from the groove 45 to the inflow end 33. The inflow end portion 301 may be designed to be large enough to provide an effective paravalvular leakage seal. For example, as shown in
The cross sections of the inflow end portion 301 and outflow end portion 302 may be or contain non-circular shapes such as elliptical or D-shaped cross sections. In addition, the direction of curvature in the axial profile (seen in an axial section along the tubular body 30) between the groove 45 and the inflow end 33 and/or between the groove 45 and outflow end 35 may change (e.g., from concave curvature of the groove 45 to a convex curvature at the transition between groove 45 and the inflow end 33 or outflow end 35).
In
The tubular body 30 may be implanted in the native valve so that the groove 45 is located at the same level of or on the ventricular side of the native annulus of a natural valve, e.g., having a distance from the natural valve annulus (see
The circumferential groove 45 may be an indentation in the tubular body 30 that is recessed radially inward so as to define a shoulder 47 on an outflow side of the groove 45, as shown in
Similar to the groove 45, the shoulder 47 may extend entirely around the circumference of the tubular body 30 or may only partially extend around the circumference of the tubular body 30. For instance, the shoulder 47 may be a continuous (i.e., non-interrupted) shoulder, or may be an interrupted shoulder 47 having, for example, two or more circumferential shoulder portions 47 that are interrupted by areas in which no shoulder portion (e.g., convex portion or bulge) is formed. The two or more circumferential shoulder portions 47 may be provided, for example, on the same axial level of the tubular body 30 or may be provided at different axial levels of the tubular body 30.
The groove and/or shoulder may be positioned at an axial height of the prosthetic leaflets of the prosthetic valve or may be positioned proximal of the prosthetic leaflets. For instance, the groove and/or shoulder may be formed in the outer surface of the tubular at an axial position at or adjacent to an axial position at which prosthetic leaflets of the valve 40 is coupled to an inner surface of the tubular body 30. Alternatively, the prosthetic valve leaflets 40 may be coupled to the tubular body 30 at a position closer to an outflow end than the groove and/or shoulder.
In
The groove 45 and/or shoulder 47 can form a leaflet engagement mechanism for engaging the native valve leaflets 12a and/or 12b during the method of implantation. For example, the shoulder 47 and/or groove 45 may be used to engage the native valve leaflets 12a, 12b during the method of implanting the prosthetic valve 1 so as to lift one or more of the native leaflets 12a, 12b in a proximal direction towards an atrial chamber of the heart, e.g., the left atrium 15 (in the case of the mitral valve) or the right atrium (in the case of the tricuspid valve). As a result, the native leaflets 12a, 12b may be in an at least partially folded up state on the shoulder 47 and/or in the groove 45. This can reduce the likelihood of blockage of the LVOT or RVOT by the native valve leaflets 12a, 12b.
Alternatively, instead of being an indentation in the tubular body 30 that is recessed radially inward so as to form a shoulder 47, the groove 45 may be a portion of the tubular body 30 from which the inflow end portion 301 flares radially outward such that the groove 45 does not define a shoulder 47. Alternatively, the tubular body 30 may not include a groove 45 at all. Instead, the tubular body 30 may be a substantially cylindrical tubular body. In such embodiments, the tubular body 30 or the prosthetic heart valve system 1 may include other means for engaging the native valve leaflets 12a, 12b (i.e., other than the groove 45 and/or shoulder 47). For instance, as described below, one or more capturing elements, such as arms 48, clips, hooks or barbs 49, tethers, clips 46, a ring 80, or the like (see
As used herein, “leaflet engagement mechanism,” “engagement mechanism,” “leaflet engagement means,” or “engagement means” may refer to any one or more of a groove, recess, indentation, slit, gash, concave portion, convex portion, shoulder (with or without a proximal-facing recess), bulge, ridge, jut, ledge, hook, barb, arm, clip, tether, fastener, catch, snare, spike, flange, or the like formed on a surface of the tubular body 30 that can facilitate engagement with the native valve leaflets during the implantation method disclosed herein and/or after the prosthesis has been implanted.
Any of the engagement mechanisms may further include an outer surface with increased friction (e.g., relative to a remainder of the prosthesis) for facilitating engagement with the native valve leaflets and retention of the native leaflets in the desired position (e.g., to avoid or reduce obstruction of the LVOT or RVOT). For instance, a part or all of the outer surface of engagement mechanism (e.g., a groove, recess, indentation, slit, gash, concave portion, convex portion, shoulder, bulge, ridge, jut, ledge, hook, barb, arm, clip, tether, fastener, catch, snare, spike, flange, or the like in the tubular body may be roughened or covered with a biocompatible adhesive or sticky pad for increased friction. The increased friction may be provided on an outer surface of the tubular body at the engagement mechanism, or the increased friction may be provided on an outer surface of a fabric covering the engagement mechanism of the tubular body.
The engagement mechanism may be positioned at an axial height of the prosthetic leaflets of the prosthetic valve or may be positioned proximal of the prosthetic leaflets. For instance, the valve leaflets of the valve 40 may be coupled to an inner surface of the tubular body at an axial position at or adjacent to an axial position at which the engagement mechanism is formed in the outer surface or coupled to the outer surface of the tubular body 30. Alternatively, the prosthetic valve leaflets 40 may be coupled to the tubular body 30 at a position closer to an outflow end than the engagement mechanism.
As discussed above,
The arms 48 may be curved in a proximal direction (i.e., in a direction towards in the inflow end 33 of the tubular body), as shown in
The arms 48 may be attached to the tubular body at the outflow end portion 302, as shown in
The tubular body 30 may additionally or alternatively include arms 48 coupled to the inflow end portion 301 of the tubular body (not illustrated). The arms 48 coupled to the inflow end portion 301 may project radially outwardly from the outer surface of the inflow end portion 301 so as to extend in the radial direction or may be inclined in a direction toward the outflow end 35. Alternatively, the arms 48 may extend substantially axially (e.g., substantially parallel to the longitudinal axis L of the tubular body 30). The arms 48 coupled to the inflow end portion 301 may extend from a first end to a second free end or may have both ends coupled to the tubular body 30 in the same manner described above for the arms 48 coupled to the outflow end portion 302.
The tubular body 30 may include first and second sets of arms 48 that respectively extend from the outflow end portion 302 and the inflow end portion 301. The first set of arms 48 may extend from the outflow end portion 302 in a direction towards the second set of arms 48 extending from the inflow end portion 301. The first and/or second set of arms 48 may extend so as to at least partially or completely overlap the groove 45 in the radial direction.
The arms 48 may further include barbs or hooks (e.g., at the second, free ends) for penetrating the native heart tissue, such as the native leaflets 12a, 12b. Alternatively, the arms 48 may include blunt, flat, or rounded free ends so as to not penetrate the native heart tissue, e.g., to avoid damaging the native heart tissue.
The tubular body 30 may include one or more arms 48. For example, the tubular body may include two arms 48 on opposite sides of the tubular body for engaging the anterior and posterior leaflets 12a, 12b when implanted. Alternatively, in the case of functionally replacing the native tricuspid valve (with three valve leaflets), the tubular body 30 may include three arms 48 spaced for engaging the three native valve leaflets. Alternatively, the tubular body 30 may only include a single arm 48 positioned for engaging the native anterior leaflet 12a of the mitral or tricuspid valve so as to reduce or avoid obstruction of blood flow from the ventricular chamber to the aorta or pulmonary artery by the anterior leaflet 12a. In yet another embodiment, the tubular body 30 may include a plurality of arms 48 spaced at equal or non-equal intervals around the circumference of the tubular body.
The arms 48 may be covered by the fabric 42 disposed on an outer surface of the tubular body 30 so as to form a pocket for capturing the native valve leaflets 12a, 12b. Alternatively, the arms 48 may project through the fabric 42 or may be otherwise uncovered by the fabric 42.
With reference to
With reference to
The transcatheter valve prosthesis 1 may include a fabric 42 disposed at least partially around the tubular body 30. The fabric 42 can function as a buffer to limit erosion in the contact areas of the native anatomy or as a matrix favoring native tissue ingrowth or as a sealing member to occlude or fill gaps between the perimeter of a tubular body 30 and the native valve annulus 11 and leaflets 12a, 12b, thereby reducing, minimizing, or eliminating leaks there-through. As shown in
When the tubular body 30 includes an engagement mechanism, such as arms 48, the fabric 42 may extend over a free end of the arms 49. For example, the arms 48 may project from a position near the shoulder 47, and the fabric 42 may extend from the inflow end portion 301 over the groove 45 and/or shoulder 47 and over a free end of the arms 48. The fabric 42 may further extend in the distal direction to a position near the attachment of the arms 48 to the tubular body 30 or may terminate just below (e.g. distal of) the free end of the arms 48. In such embodiments, a pocket or channel may be formed by the fabric 42 extending over the free end of the arms 48 in between the arms 48 and the outer surface of the tubular body 30, e.g., an outer surface of the groove 45 and/or shoulder 47. The pocket may further facilitate engagement and retention of the native valve leaflets 12a, 12b on the engagement means.
As shown in
In
The fabric 42 covering the inflow end portion 301 may also include one or more lateral openings 421. The lateral opening(s) 421 may have any of the configurations discussed above.
When one or more grooves 45 extend only partially around the circumference of the tubular body 30 (e.g., when the tubular body includes an interrupted groove that is interrupted by areas in which no groove or recessed portion is formed), the groove 45 (e.g., recessed portion) may be formed on a side of the tubular body 30 where one or more lateral openings 421 are present. For instance, the partial circumference groove 45 or recessed portion may be substantially aligned with a lateral opening 421 in the fabric 42 or may at least partially overlap a lateral opening 421 in the fabric 42 in the axial direction (along axis L) of the tubular body 30. The partially circumference groove 45 (e.g., recessed portion) may thus form a partially circumferential shoulder 47 that is aligned with or at least partially overlaps a lateral opening 421 in the fabric 42 in the axial L direction of the tubular body 30. The tubular body 30 may be implanted inside the native mitral or tricuspid valve 5 such that at least one lateral opening 421, at least one groove (e.g., recessed) portion 45, and at least one shoulder 47 portion are disposed so as to face in a direction of the anterior leaflet and/or the aortic valve (in the case of the mitral valve) or the pulmonic valve (in the case of the tricuspid valve).
As a result, the leaflet engagement mechanism, including the groove portion 45 and/or the shoulder portion 47, can engage the native anterior leaflet 12a of the mitral or tricuspid valve 5 so as to lift the native leaflet 12a in the proximal direction (e.g., toward the atrial chamber) to avoid obstruction of the LVOT or RVOT by the native leaflet 12a. Obstruction of the opening(s) 421 in the fabric 42 on the anterior side can be avoided or reduced so as to permit blood flow there through towards the aortic valve (in the case of the mitral valve) or the pulmonic valve (in the case of the tricuspid valve) to further reduce or avoid obstruction of the LVOT or RVOT.
The fabric 42 may include one or more segments of material. For instance, the fabric 42 may include one segment of material that completely or partially circumscribes the tubular body 30. Alternatively, the fabric 42 may include multiple segments, for example, two, four, or six segments. The segments may be overlapping or may be spaced apart so as to provide gaps between adjacent segments. The gaps between adjacent segments may provide the lateral openings 421 for facilitating blood flow through the outflow end portion 302 of the tubular body 30. The fabric 42 may be continuous with, for example, liner (not shown) disposed on an inner surface of the tubular body 30. The fabric 42 may include one layer of material or multiple layers of materials.
Suitable materials for the fabric include, but are not limited to, a low-porosity woven fabric, such as a polyester, DACRON® fabric, or other PTFE graft material, or the fabric 42 may include pericardial tissue, and/or a metal mesh material (e.g., a metal mesh formed of Nitinol). Porous materials can provide a medium for tissue ingrowth, and bioabsorbable materials and/or polyurethane foam with low density and optimal porosity promote sealing of the prosthesis 1 to the anatomy. Woven or knit materials can also provide a medium for tissue ingrowth and have the ability to stretch to conform to a curved surface.
The fabric 42 may be attached to tubular body 30 through any known securing mechanism. For example, the fabric 42 and the tubular body 30 may be secured through an adhesive, sutures, clips, barbs, metal or plastic bands, or any other suitable coupling element. The fabric 42 may be configured to assume a deployed, expanded configuration and a contracted, reduced configuration with the tubular body 30. Thus, the fabric 42 may be expanded and contracted based on the state of the tubular body 30.
The prosthesis 1 may further include a support member 80 to further secure the tubular body in the native valve and facilitate engagement with the native valve leaflets (see
The support member 80 may comprise a tubular structure having a longitudinal axis that may be arranged so as to extend in the circumferential groove 45 in a circumferential direction of the tubular body 30. The support member 80 may be in contact with the groove shoulder 47 of the circumferential groove 45. The support member 80 may extend around a whole circumference of the tubular body 30 or only partially around the tubular body 30. The clamping member 80 may extend, e.g., around an angle of 10 to 30 degrees or any other angle in the circumferential groove 45. The clamping member 80 may extend around the whole circumference of groove 45, e.g., around 360 degrees.
Thus, the support member 80 may trap or clamp portions of native valve leaflets 12a, 12b in preformed groove 45 or against a surface of the tubular body 30. This may help secure the tubular body 30 in a patient. The support member 80 can be introduced around the native valve leaflets 12a, 12b either before or after the tubular body 30 has been introduced inside the native heart valve 5. The support member 80 may include an outer surface with increased friction for facilitating engagement with the native valve leaflets and retention of the native leaflets in the desired position (e.g., to avoid or reduce obstruction of the LVOT or RVOT. For instance, an outer surface of the support member 80 may be roughened, or provided with a biocompatible adhesive or sticky pad to increase friction for better retention of the native valve leaflets. Alternatively, a fabric, such as that discussed above, may cover all or part of the support member 80. An outer surface of the fabric may be provided with increased friction for the same reason.
The support member 80 may include a full or partial loop. Additionally, the support member 80 may be moved around the tubular body 30 after the tubular body 30 is fully expanded or when the tubular body 30 is only partially expanded. The support member 80 may be loosely disposed within the preformed groove 45 such that an interference fit between the trapping member support member 80 and the preformed groove 45 secures the tubular body 30 in place. Alternatively, the support member 80 may clamp or pinch the native valve leaflets in the groove 45 or otherwise against an outer surface of the tubular body 30 to secure the tubule body in the native valve. Thus, the support member 80 may serve to anchor the valve prosthesis 1 within the patient. In other embodiments, the support member 80 may exert an inward, radial force on the tubular body 30 in order to anchor valve prosthesis 1 within the patient. Alternatively or additionally, the support member 80 may exert a frictional force on the native valve leaflets 12a, 12b.
The support member 80 may include a delivery configuration within a delivery catheter and a deployment configuration in which the support member 80 is deployed from the delivery catheter. In embodiments, the support member 80 may be biased to the deployment configuration. For example, the support member 80 may include a shape-memory alloy such as a Nitinol or a Nitinol-based alloy. Alternatively, the support member 80 may be introduced over an elongate member 75, such as a guidewire, as discussed below. The elongate member 75 may be removed from the patient after implanting the prosthesis 1 in the native heart. Alternatively, the elongate member 75 may be part of the prosthesis and thus may remain in the patient after implantation. The support member 80 and/or elongate member 75 can be introduced around the native valve leaflets 12a, 12b either before or after the tubular body 30 has been introduced inside the native heart valve 5.
The ring formed by the support member 80 after the prosthesis has been implanted in the native heart may be larger in circumference than a groove 45 in the tubular body 30, but smaller in circumference than a shoulder 47 in the tubular body 30. The support member 80 may have a cross-sectional diameter transverse to its longitudinal axis. The cross-sectional diameter may be selectively changeable to a larger or smaller diameter. That is, the support member 80 may be compressible (so as to be insertable via a catheter) and/or expandable (for example, re-expandable after being compressed) in a radial direction of its diameter, whereby the inner and outer circumferences of the support member 80 are correspondingly decreased/expanded and expanded/decreased, respectively, in a radial direction of the tubular body 30. The cross sectional diameter of the support member 80 may be smaller than the cross sectional diameter of the tubular body 30. In embodiments, the diameter of the support member 80 may be smaller than the width of the outer circumferential groove 45. The support member 80 may be provided in order to clamp heart tissue that is located inside the circumferential groove 45 outwards in a direction from the axis L towards the pluralities of projections 50, 55.
All embodiments of valve prosthesis 1 may include positioning and/or orientation devices (not shown) to facilitate relative and/or absolute positioning of the tubular body 30. These devices may include passive markers that are fixedly attached to the tubular body 30. The passive markers may be made from materials different from the materials of the tubular body 30 in order to improve contrast during medical imaging, e.g., using magnetic resonance or X-ray based imaging techniques. The passive markers may, for example, be made of highly radio-opaque materials thereby allowing one to precisely acquire the relative and/or absolute position of the components of valve prosthesis 1 with respect to the patient's body.
The prosthesis 1 can be delivered and deployed within the left ventricle of the heart to limit or prevent LVOT obstruction or can be delivered and deployed within the right ventricle of the heart to limit or prevent RVOT obstruction. With the prosthesis 1 implanted and radially expanded within native mitral or tricuspid valve, the tubular body 30 creates and/or expands a passageway in the LVOT or RVOT, and limits or prevents a native leaflet 12a, 12b (e.g., native anterior mitral leaflet or native anterior or septal tricuspid leaflet) from occluding the passageway. For instance, blood can flow through the lateral openings 421 in the fabric 42 at the outflow end portion 302 of the tubular body 30. Additionally, the leaflet engagement mechanism and implantation technique help move at least one of the leaflets (e.g., at least the anterior leaflet) in the proximal direction (e.g., towards the left or right atrium) so as to reduce or eliminate LVOT or RVOT obstruction by the native valve leaflets (e.g., anterior leaflet).
The first delivery catheter 50 may include a first delivery sheath and a second delivery sheath that each include inner lumens and are housed within and can be advanced through the inner lumen of the first delivery catheter 50. An elongate member 75, such as a guidewire, may be advanced from the first delivery catheter 50 around the native valve leaflets 12a, 12b. The elongate member 75 may contact and deflect from a wall defining the left ventricle 10 so as to curve around the native leaflets 12a, 12b, for example, at a position near the native valve annulus 11. Alternatively, the elongate member 75 may be pre-shaped to curve around native leaflets 12a, 12b, or the deliver catheter 50 or a delivery sheath housed therein may be pre-shaped so as to curve around the native valve lefts 12a, 12b once advanced from a distal end of the first delivery catheter 50. The elongate member 75 is guided around the native leaflets 12a, 12b and not around the chordae tendinae 13, which could otherwise undesirably result in elongate member 75 being caught on or placed between chordae tendinae 13. The elongate member 75 may form a contractible loop (e.g., like a lasso) around the native valve leaflets 12a, 12b having a greater diameter than an outer diameter of the leaflets 12a, 12b, as shown in
The elongate member 75 may form the loop shown in
Then, as shown in
The technique for introducing the support member 80 around the native valve leaflets by being guided over the elongate member 75 is not limited to the exemplary embodiment illustrated in
As shown in
The second delivery catheter 60 includes the tubular body 30 in a compressed state. For example, the tubular body 30 may be disposed inside an inner lumen of the second delivery catheter, and can be radially compressed to facilitate delivery of the prosthesis 1 to the native valve. The second delivery catheter 60 is advanced through the left atrium 15 inside the native leaflets 12a, 12b (e.g., anterior and posterior leaflets) of the native mitral valve, and into the left ventricle 10. The catheter 60 can be positioned in the left ventricle 10 such that the shoulder 47 of the compressed tubular body 30 or a proximal end of the outflow end section 302 is positioned distal of the support member 80 in an axial direction. That is, the shoulder 47 the proximal end of the outflow end section 302 can be distally spaced from the support member 80 in a direction away from the native valve 5 (e.g., further into the left ventricle 10). The second delivery catheter 60 may be positioned in the left ventricle 10 such that the shoulder 47 or proximal end of the outflow end portion 302 is distal of the a distal edge 121a, 121b of at least one of the native leaflets 12a, 12b in the axial direction. For instance, the second delivery catheter 60 may be positioned in the left ventricle 10 such that the shoulder 47 or proximal end of the outflow end portion 302 is distal of the distal edge 121a of at least the anterior leaflet 12a of the mitral valve 5, and/or a distal edge 121b of the posterior leaflet 12b of the native mitral valve 5.
Likewise, when the prosthesis 1 is implanted into the native tricuspid valve, the second delivery catheter 60 may be position such that the shoulder 47 and/or proximal end of the outflow end portion 302 of the tubular body 30 is distal of the support member 80, which is disposed around the native tricuspid valve leaflets in between the native annulus and papillary muscles, and/or is distal of a distal edge of one, two, or all three of the native leaflets (e.g., the anterior, septal, and/or posterior leaflets) of the native tricuspid valve.
The “distal edge” of the leaflets as used herein may refer to an edge of the leaflets where the chordae tendinae 13 attach to the native leaflets, and/or may refer to an edge of the native valve leaflets that extends farther into a ventricular chamber of the heart (e.g., in a direction away from an atrial chamber and/or the native valve annulus) than a remaining part of the native leaflet. For instance, for the native mitral valve 5, a distal edge 121a, 121b may be an outer edge of the native valve leaflets 12a, 12b that extends deeper into the left ventricle 10 in a direction away from the left atrium 15, e.g., during diastole. For the native tricuspid valve, a distal edge may be an outer edge of the native valve leaflets that extends deeper into the right ventricle in a direction away from the right atrium, e.g., during diastole.
Once the second delivery catheter 60 has been positioned in the left ventricle 10, the tubular body 30 can be partially deployed from the second delivery catheter 60, as illustrated in
The tubular body 30 may be partially deployed such that the leaflet engagement mechanism (e.g., clips 46, shoulder 47, groove 45, arms 48, barbs or hooks 49) or a proximal end of the outflow end portion 302 is positioned distal of the distal edge 121a, 121b of at least one of the native leaflets 12a, 12b. For example, in
The leaflet engagement mechanism may be spaced in the distal direction from the distal edge 121a of at least the anterior leaflets 12a and/or may be spaced in the distal direction from the distal edge 121b of the posterior leaflet 12b of the native mitral or tricuspid valves (and/or the septal leaflet of the native tricuspid valve). By deploying the outflow end portion 302 of the tubular body 30 such that the leaflet engagement mechanism is distal of the distal edge 121a, 121b of the native valve leaflets 12a, 12b, the native leaflets can be at least partially captured and moved by the leaflet engagement mechanism to a position less likely to obstruct the LVOT or RVOT.
The tubular body 30 can be partially deployed from the second delivery catheter 60 by, for example, retracting a sheath of the second delivery catheter 60 until the engagement mechanism (e.g., clips 46, shoulder 47, arms 48, barbs or hooks 49) or a proximal end of the outflow end portion 302 deploys from the catheter 60. Thus, in the partially deployed state, the outflow end portion 302 radially expands to an expanded stated, as shown in
Then, as shown in
As shown in
As a result, the native leaflets 12a, 12b do not block or entirely block the LVOT or RVOT such that blood can flow from the ventricular chamber to the aorta or pulmonary artery. Additionally, the native leaflets 12a, 12b do not cover or entirely block the lateral openings 421 in the fabric 42 on the outflow end portion 301 of the tubular body 30. Thus, the lateral openings 421 in the fabric 42 may remain mostly or entirely free of obstruction by the leaflets 12a, 12b. This permits blood flow through the lateral openings 421 and avoids or reduces obstruction of the LVOT or RVOT.
In some embodiments, just one of the leaflets 12a, 12b may be engaged by the engagement means and lifted in the proximal direction so as to be positioned between the engagement means and the support member 80. For instances, just the anterior leaflet 12a may be engaged by the engagement means, e.g., shoulder 47, and lifted in the proximal direction so as to be sandwiched between the engagement means and the support member 80. As such, a lateral opening 421 in the fabric 42 on the anterior side of the outflow end portion 302 of the tubular body can be substantially or entirely uncovered by the native anterior leaflet 12a so as to permit blood flow therethrough to the aorta 20. Alternatively, just the posterior leaflet 12b may be engaged and lifted by the engagement means in the proximal direction so as to be sandwiched between the engagement means and the support member 20.
Once the leaflet(s) 12a, 12b have been captured by the engagement means and lifted in the proximal direction, the inflow end portion 301 of the tubular body 30 can be deployed from the second delivery catheter 60.
After the tubular body 30 is fully deployed, the at least one native valve leaflet 12a, 12b can be captured by the engagement mechanism in a folded up state proximal of the outflow end 35 of the tubular body 30, for example on a proximal side of the outflow end portion 302. Upon implantation of the prosthesis, the leaflets can thus be immobilized in an at least partially folded up or bunched up state. The may avoid undesirable leaflet motion, such as systolic anterior motion in the LVOT. Additionally, the immobilized native leaflets 12a, 12b in the at least partially folded up or bunched up state between the inflow end portion 301 and the outflow end portion 302 can facilitate sealing around the valve. The at least one native valve leaflet 12a, 12b can be captured by the engagement mechanism at a position proximal of a lateral opening 421 in the fabric 42 such that the at least one native valve leaflet 12a, 12b does not obstruct the lateral opening 421.
When a support member 80 is used in combination with the tubular body 30, the leaflets 12a, 12b can also be sandwiched between the engagement mechanism and the support member 80. For example, in
Although the exemplary method for implanting the prosthesis 1 and the support member 80 described above utilizes arterial retrograde approach through a patient's aortic arch (for delivering the support member 80) and a trans-septal approach for delivering the tubular body 30, any other suitable technique may be used. For instance, the valve prosthesis 1 and support member 80 may be implanted within the patient's heart valve by any one or more of the following approaches: (1) an arterial retrograde approach entering the heart cavity over the aorta, (2) through a venous access and through a puncture through the inter atrial septum (trans-septal approach), (3) over a puncture through the apex of the heart (trans-apical approach), (4) over a puncture through the atrial wall from outside the heart, (5) arterial access (e.g., from the femoral artery through a puncture in the groin), (6) directly through the vena cava and into the right atrium (for a tricuspid valve replacement, for example), or (7) any other approach known to a skilled person.
In the above exemplary method, the support member 80 was delivered around the native valve leaflets 12a, 12b before the tubular body 30 was delivered inside the native valve 5. Alternatively, the tubular body 30 could be delivered inside the native valve 5 in between the leaflets 12a, 12b before the support member is introduced around the native valve leaflets 12a, 12b. In such embodiments, the tubular body 30 may be first partially deployed from the delivery catheter 60 such that only the outflow end portion 302 is deployed. The outflow end portion 302 may be moved in the proximal direction (e.g., by moving the catheter 60) to engage and lift the native leaflets 12a, 12b via the engagement means. The support member 80 may be introduced either before or after the inflow end portion 301 of the tubular body 30 is deployed from the delivery catheter. After circumventing the native leaflets 12a, 12b, the diameter of the support member 80 and/or elongate member 75 may be reduced to help secure the leaflets 12a, 12b into engagement with the engagement means, such as the shoulder 47 and/or the groove 45 on the tubular body 30.
In the above exemplary method, two delivery catheters 50, 60 were used to implant the support member 80 and the tubular body 30. However, the method is not limited to this, and may involve only a single delivery catheter for both of the support member 80 and the tubular body 30, or may be include more than two delivery catheters 50, 60.
The disclosed methods of implanting valve prosthesis 1 may result in fixation of the tubular body 30 in the patient's native valve with minimal or no obstruction of the LVOT or RVOT.
The illustrated exemplary embodiments of the prosthesis and method of implantation as set forth above are intended to be illustrative and not limiting and can be combined. Various changes may be made without departing from the spirit and scope of the disclosure.
This nonprovisional application claims the benefit of U.S. Provisional Application No. 63/044,534 filed Jun. 26, 2020. The entire content of the prior application is hereby incorporated herein by reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 6120534 | Ruiz | Sep 2000 | A |
| 7806927 | Styrc | Oct 2010 | B2 |
| 8236049 | Rowe et al. | Aug 2012 | B2 |
| 8323335 | Rowe et al. | Dec 2012 | B2 |
| 8449605 | Lichtenstein et al. | May 2013 | B2 |
| 8597348 | Rowe et al. | Dec 2013 | B2 |
| 8623079 | Savage et al. | Jan 2014 | B2 |
| 8956404 | Bortlein et al. | Feb 2015 | B2 |
| 9358108 | Bortlein et al. | Jun 2016 | B2 |
| 9375312 | Weber | Jun 2016 | B2 |
| 9387075 | Bortlein et al. | Jul 2016 | B2 |
| 9662206 | Bortlein et al. | May 2017 | B2 |
| 9687343 | Bortlein et al. | Jun 2017 | B2 |
| 9763779 | Bortlein et al. | Sep 2017 | B2 |
| 9889003 | Bortlein et al. | Feb 2018 | B2 |
| 9931206 | Weber | Apr 2018 | B2 |
| 10064719 | Börtlein | Sep 2018 | B2 |
| 10080651 | Bortlein et al. | Sep 2018 | B2 |
| 10828157 | Bortlein et al. | Nov 2020 | B2 |
| 20010039450 | Pavcnik | Nov 2001 | A1 |
| 20020055774 | Liddicoat | May 2002 | A1 |
| 20020099438 | Furst | Jul 2002 | A1 |
| 20020193871 | Beyersdorf et al. | Dec 2002 | A1 |
| 20030070683 | Deem et al. | Apr 2003 | A1 |
| 20030125798 | Martin | Jul 2003 | A1 |
| 20040015232 | Shu et al. | Jan 2004 | A1 |
| 20040044406 | Woolfson et al. | Mar 2004 | A1 |
| 20040186565 | Schreck | Sep 2004 | A1 |
| 20040210304 | Seguin | Oct 2004 | A1 |
| 20040243227 | Starksen et al. | Dec 2004 | A1 |
| 20050049681 | Greenhalgh | Mar 2005 | A1 |
| 20050055082 | Ben Muvhar et al. | Mar 2005 | A1 |
| 20050060029 | Le | Mar 2005 | A1 |
| 20050113910 | Paniagua | May 2005 | A1 |
| 20050137686 | Salahieh et al. | Jun 2005 | A1 |
| 20050182486 | Gabbay | Aug 2005 | A1 |
| 20060058872 | Salahieh et al. | Mar 2006 | A1 |
| 20070027534 | Bergheim | Feb 2007 | A1 |
| 20070129795 | Hill et al. | Jun 2007 | A1 |
| 20070142906 | Figulla et al. | Jun 2007 | A1 |
| 20070142907 | Moaddeb et al. | Jun 2007 | A1 |
| 20070213813 | Von Segesser et al. | Sep 2007 | A1 |
| 20080071361 | Tuval et al. | Mar 2008 | A1 |
| 20080071369 | Tuval et al. | Mar 2008 | A1 |
| 20080077234 | Styrc | Mar 2008 | A1 |
| 20080077236 | Letac et al. | Mar 2008 | A1 |
| 20090319037 | Rowe et al. | Dec 2009 | A1 |
| 20100094411 | Tuval et al. | Apr 2010 | A1 |
| 20100145438 | Barone | Jun 2010 | A1 |
| 20100256751 | Rowe et al. | Oct 2010 | A1 |
| 20100298931 | Quadri et al. | Nov 2010 | A1 |
| 20100312333 | Navia et al. | Dec 2010 | A1 |
| 20110137397 | Chau et al. | Jun 2011 | A1 |
| 20110218620 | Meiri et al. | Sep 2011 | A1 |
| 20110224785 | Hacohen | Sep 2011 | A1 |
| 20110238168 | Pellegrini et al. | Sep 2011 | A1 |
| 20110264196 | Savage et al. | Oct 2011 | A1 |
| 20110313515 | Quadri et al. | Dec 2011 | A1 |
| 20110319988 | Schankereli et al. | Dec 2011 | A1 |
| 20120022640 | Gross et al. | Jan 2012 | A1 |
| 20120035722 | Tuval | Feb 2012 | A1 |
| 20120053682 | Kovalsky et al. | Mar 2012 | A1 |
| 20120078353 | Quadri et al. | Mar 2012 | A1 |
| 20120215303 | Quadri et al. | Aug 2012 | A1 |
| 20130090726 | Rowe et al. | Apr 2013 | A1 |
| 20130116779 | Weber | May 2013 | A1 |
| 20130211508 | Lane et al. | Aug 2013 | A1 |
| 20130226289 | Shaolian et al. | Aug 2013 | A1 |
| 20130253642 | Brecker | Sep 2013 | A1 |
| 20130261741 | Accola | Oct 2013 | A1 |
| 20130274873 | Delaloye et al. | Oct 2013 | A1 |
| 20130289718 | Tsukashima et al. | Oct 2013 | A1 |
| 20130310928 | Morriss et al. | Nov 2013 | A1 |
| 20130325114 | McLean et al. | Dec 2013 | A1 |
| 20140018915 | Biadillah et al. | Jan 2014 | A1 |
| 20140052237 | Lane et al. | Feb 2014 | A1 |
| 20140243966 | Garde et al. | Aug 2014 | A1 |
| 20140277390 | Ratz et al. | Sep 2014 | A1 |
| 20140277411 | Bortlein et al. | Sep 2014 | A1 |
| 20140277412 | Bortlein et al. | Sep 2014 | A1 |
| 20140277424 | Oslund | Sep 2014 | A1 |
| 20140277427 | Ratz et al. | Sep 2014 | A1 |
| 20140296969 | Tegels | Oct 2014 | A1 |
| 20140324164 | Gross et al. | Oct 2014 | A1 |
| 20140358224 | Tegels | Dec 2014 | A1 |
| 20150127093 | Hosmer et al. | May 2015 | A1 |
| 20150142100 | Morriss et al. | May 2015 | A1 |
| 20150148896 | Karapetian | May 2015 | A1 |
| 20160120642 | Shaolian et al. | May 2016 | A1 |
| 20170189177 | Schweich, Jr. et al. | Jul 2017 | A1 |
| 20170266003 | Hammer | Sep 2017 | A1 |
| 20180125647 | Nasr | May 2018 | A1 |
| 20180193140 | Weber | Jul 2018 | A1 |
| 20200078170 | Weber | Mar 2020 | A1 |
| 20200078171 | Weber | Mar 2020 | A1 |
| 20200093596 | Weber | Mar 2020 | A1 |
| 20210015605 | Bortlein et al. | Jan 2021 | A1 |
| Number | Date | Country |
|---|---|---|
| 697 30 840 | Sep 2005 | DE |
| 102005052628 | May 2007 | DE |
| 10 2011 054 172 | Mar 2013 | DE |
| 2009053497 | Apr 2009 | WO |
| 2009155561 | Dec 2009 | WO |
| 2010008548 | Jan 2010 | WO |
| 2011111047 | Sep 2011 | WO |
| 2011137531 | Nov 2011 | WO |
| 2013037519 | Mar 2013 | WO |
| 2013120181 | Aug 2013 | WO |
| 2014080339 | May 2014 | WO |
| Entry |
|---|
| Boudjemline et al. “Steps Toward Percutaneous Aortic Valve Replacement,” Circulation, vol. 105, Feb. 2002, pp. 775-778. |
| Lee et al. “Survival and recurrence after acute pulmonary embolism treated with pulmonary embolectomy or thrombolysis in New York State, 1999 to 2013,” The Journal of Thoracic and Cardiovascular Surgery, vol. 155, No. 3, Mar. 2018, pp. 1084-1090. |
| Liang et al., “Double-crowned valved stents for off-pump mitral valve replacement,” European Journal of Cardio-thoracic Surgery, vol. 28, 2005, pp. 194-199. |
| Number | Date | Country | |
|---|---|---|---|
| 20210401572 A1 | Dec 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| 63044534 | Jun 2020 | US |
