Patent Application
20240207045
The present invention relates to medical apparatus and methods, and specifically to apparatus and methods for implanting a prosthetic valve at a tricuspid valve.
The human heart is a muscular organ that pumps deoxygenated blood through the lungs to oxygenate the blood and pumps oxygenated blood to the rest of the body by contractions of four chambers.
After having circulated in the body, deoxygenated blood from the body enters the right atrium through the vena cava(s). In a healthy subject, the right atrium contracts, pumping the blood through the tricuspid valve into the right ventricle. The right ventricle contracts, pumping the blood through the pulmonary semi-lunar valve into the pulmonary artery which splits to two branches, one for each lung. The blood is oxygenated while passing through the lungs, and reenters the heart via the left atrium. The left atrium contracts, pumping the oxygenated blood through the mitral valve into the left ventricle. The left ventricle contracts, pumping the oxygenated blood through the aortic valve into the aorta to be distributed to the rest of the body. The tricuspid valve closes during right ventricle contraction, so that backflow of blood into the right atrium is prevented. Similarly, the mitral valve closes during left ventricle contraction, so that backflow of blood into the left atrium is prevented. The mitral valve and the tricuspid valve are known as atrioventricular valves, each of these valves controlling the flow of blood between an atrium and a ventricle.
The tricuspid valve includes three leaflets: the septal leaflet, the anterior leaflet, and the posterior leaflet. Each of the valve leaflets is attached to the tricuspid valve annulus, which defines the tricuspid valve orifice. The leaflets are connected to papillary muscles within the right ventricle and/or to the right ventricular wall, by chords. In a healthy subject the tricuspid valve controls the direction of blood flow from the right atrium to the right ventricle, as described above. Tricuspid valve regurgitation occurs when the tricuspid valve fails to close properly. This can cause blood to flow back up into the right atrium when the right ventricle contracts. Tricuspid valve regurgitation is most commonly caused by right ventricle dilation, which leads to the tricuspid valve annulus dilating, resulting in the valve leaflets failing to coapt properly.
In accordance with some applications of the present invention, prosthetic tricuspid valve leaflets are disposed within a prosthetic tricuspid valve frame. The prosthetic tricuspid valve frame is typically delivered to a subject's native tricuspid valve through the subject's inferior or superior vena cava. Typically, the tricuspid valve frame includes an anchoring arm at a circumferential region corresponding to the septal leaflet of the native tricuspid valve and includes a plurality of chord-recruiting arms at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve. For some applications, the prosthetic tricuspid valve frame includes a valve-frame body that defines a ventricular portion (which upon deployment is configured to be disposed within the subject's right ventricle), and an atrial portion (which upon deployment is configured to be disposed within the subject's right atrium). The prosthetic tricuspid valve frame typically supports a plurality of prosthetic tricuspid valve leaflets (e.g., two leaflets, or three leaflets, as shown), which are sutured or otherwise coupled to the valve-frame body.
Typically, in a non-constrained configuration of the prosthetic tricuspid valve frame, the chord-recruiting arms extend radially from a portion of valve-frame body that is configured to be placed within the subject's ventricle. For some applications, in a non-radially-constrained configuration of the valve frame, the chord-recruiting arms encompass more than 40 percent of the circumference of the valve-frame body (e.g., more than 60 percent of the circumference of the valve-frame body), and/or less than 80 percent of the of the circumference of the valve-frame body (e.g., less than 70 percent of the circumference of the valve-frame body). Typically, the chord-recruiting arms are configured to be disposed at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve, and are configured to recruit the chords of the aforementioned leaflets, as described in further detail hereinbelow. Typically, the chord-recruiting arms are configured to extend radially from the valve-frame body, in addition to extending axially from a ventricular end of the valve-frame body (i.e., the end of the valve-frame body that is configured to be placed within the ventricle) toward an atrial end of the valve-frame body (i.e., the end of the valve-frame body that is configured to be placed within the atrium). Further typically, the chord-recruiting arms curve around the outside of the valve-frame body in a given circumferential direction of curvature (i.e., clockwise or counterclockwise). For some applications, the chord-recruiting arms are configured to have concavely rounded leading edges facing in the given circumferential direction.
Typically, there are no chord-recruiting arms disposed at a circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve. For example, in the non-radially-constrained configuration of the valve frame, the valve frame may include no chord-recruiting arms (or any portions thereof) around at least 20 percent (or at least 30 percent) of the circumference of the valve-frame body, in a non-radially-constrained configuration of the valve frame. For some applications, in the non-radially-constrained configuration of the valve frame, the valve frame does not include any arms (or any portions thereof) around at least 20 percent (or at least 30 percent) of the circumference of the valve-frame body, in a non-radially-constrained configuration of the valve frame. For some applications, at the circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve, the anchoring arm extends radially from the portion of the valve-frame body that is configured to be placed within the subject's ventricle. Typically, the anchoring arm has a different shape and/or length, and a different function from chord-recruiting arms, as described in further detail hereinbelow. For some applications, the valve frame does not include any arms (i.e., it does not include an anchoring arm or chord-recruiting arms) at the circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve.
For some applications, the tricuspid valve frame includes a coronary-sinus anchor that is configured to become anchored within the subject's coronary sinus. Typically, the coronary-sinus anchor is an elongate anchor that is configured, in a non-constrained configuration thereof, to extend radially from the atrial portion of the valve-frame body. Further typically, the anchor is configured be curved circumferentially with respect to the atrial portion of the valve-frame body, such as to conform with the curved shape of the coronary sinus. The coronary-sinus anchor is configured to be inserted into the ostium of the coronary sinus within the right atrium, and to then be advanced into the coronary sinus by rotation of the valve frame. The coronary sinus is typically situated in the vicinity of the septal leaflet. As such, the coronary-sinus anchor typically provides anchoring of the valve frame with respect to the native tricuspid valve at the circumferential region corresponding to the septal leaflet. Typically, the coronary-sinus anchor is constructed from a shape-memory material (e.g., a shape-memory alloy, such as nitinol and/or copper-aluminum-nickel), which is covered with a covering material, e.g., a fabric and/or a polymer (such as expanded polytetrafluoroethylene (ePTFE), or woven, knitted and/or braided polyester).
There is therefore provided, in accordance with some applications of the present invention, apparatus for use with a native tricuspid valve of a heart of a mammalian subject, the native tricuspid valve including an anterior leaflet, a posterior leaflet, and a septal leaflet, and chords extending to each of the leaflets, the apparatus including:
In some applications, the valve-frame body further includes an atrial portion configured to be deployed in a right atrium of the subject, and the valve frame further includes a coronary-sinus anchor that extends radially from the atrial portion of the valve-frame body, the coronary-sinus anchor being configured to be inserted into a coronary sinus of the subject and to thereby anchor the valve frame with respect to the native tricuspid valve.
In some applications, the apparatus further includes a delivery catheter configured to:
In some applications, the delivery catheter is configured to cause the valve-frame body to radially expand, such as to trap the anterior and posterior leaflets in a partially closed and twisted configuration, to thereby at least partially seal a space between the native tricuspid valve and the valve frame.
In some applications, the anchoring arm is not configured to manipulate a shape of the septal leaflet in a manner in which the chord-recruiting arms are configured to manipulate shapes of the anterior and posterior leaflets by the portion of the valve frame being rotated.
In some applications, in a non-radially-constrained configuration of the valve frame, the chord-recruiting arms encompass less than 80 percent of a circumference of the valve-frame body.
In some applications, in the non-radially-constrained configuration of the valve frame, the chord-recruiting arms encompass more than 40 percent of the circumference of the valve-frame body.
In some applications, the anchoring arm and the chord-recruiting arms are configured to assume chord-deployment configurations by being released from their radially constrained configurations while a portion of the valve frame from which the arms extend is still maintained in a radially-constrained configuration, and the anchoring arm is configured to become deployed among chords that extend to the septal leaflet by assuming its chord-deployment configuration, and the chord-recruiting arms are configured to become deployed among chords that extend to the anterior leaflet and among chords that extend to the posterior leaflet by assuming their chord-deployment configurations.
In some applications, in the chord-deployment configurations of the arms, a ratio of the length of the anchoring arm to lengths of each of the chord recruiting arms when measured along a center of each of the arms from a base of the arm to a tip of the arm is greater than 4:3.
In some applications, in the chord-deployment configurations of the arms, a ratio of the length of the anchoring arm to lengths of each of the chord recruiting arms when measured along the center of each of the arms from the base of the arm to the tip of the arm is greater than 2:1.
There is further provided, in accordance with some applications of the present invention, apparatus for use with a native tricuspid valve of a heart of a mammalian subject, the native tricuspid valve including an anterior leaflet, a posterior leaflet, and a septal leaflet, and chords extending to each of the leaflets, the apparatus including:
In some applications, the valve-frame body includes an atrial portion configured to be deployed in a right atrium of the subject, and the valve frame further includes a coronary-sinus anchor that extends radially from the atrial portion of the valve-frame body, the coronary-sinus anchor being configured to be inserted into a coronary sinus of the subject and to thereby anchor the valve frame with respect to the native tricuspid valve.
In some applications, the apparatus further includes a delivery catheter configured to: deliver the valve frame to the native tricuspid valve;
In some applications, in a non-radially-constrained configuration of the valve frame, the chord-recruiting arms encompass less than 80 percent of a circumference of the valve-frame body.
In some applications, in a non-radially-constrained configuration of the valve frame, the chord-recruiting arms encompass more than 40 percent of the circumference of the valve-frame body.
In some applications, in a non-radially-constrained configuration of the valve frame, the valve frame does not include any chord-recruiting arms extending from the valve-frame body around at least 20 percent of a circumference of the valve-frame body
In some applications, in the non-radially-constrained configuration of the valve frame, the valve frame does not include any chord-recruiting arms extending from the valve-frame body around at least 30 percent of the circumference of the valve-frame body
In some applications, the chord-recruiting arms are configured to extend from a longitudinal location along the valve-frame body and in a non-radially-constrained configuration of the valve frame, at the longitudinal location along the valve-frame body, the valve frame does not include any chord-recruiting arms around at least 20 percent of a circumference of the valve-frame body.
In some applications, in the non-radially-constrained configuration of the valve frame, at the longitudinal location along the valve-frame body, the valve frame does not include any chord-recruiting arms around at least 30 percent of a circumference of the valve-frame body.
In some applications, the valve-frame body includes a ventricular portion configured to be deployed in a right ventricle of the subject, and the chord-recruiting arms are configured to extend from a distal end of the ventricular portion of the valve-frame body.
There is further provided, in accordance with some applications of the present invention, apparatus for use with a native tricuspid valve of a heart of a mammalian subject, the native tricuspid valve including an anterior leaflet, a posterior leaflet, and a septal leaflet, and chords extending to each of the leaflets, the apparatus including:
In some applications, the valve frame further includes:
In some applications, in a non-radially-constrained configuration of the valve frame, the chord-recruiting arms encompass less than 80 percent of a circumference of the valve-frame body.
In some applications, the anchoring arm and the chord-recruiting arms are configured to assume chord-deployment configurations by being released from their radially constrained configurations while a portion of the valve frame from which the arms extend is still maintained in a radially-constrained configuration, and the anchoring arm is configured to become deployed among chords that extend to the septal leaflet by assuming its chord-deployment configuration, and the chord-recruiting arms are configured to become deployed among chords that extend to the anterior leaflet and among chords that extend to the posterior leaflet by assuming their chord-deployment configurations.
In some applications, in the chord-deployment configurations of the arms, a ratio of the length of the anchoring arm to lengths of each of the chord recruiting arms when measured along a center of each of the arms from a base of the arm to a tip of the arm is greater than 4:3.
In some applications, in the chord-deployment configurations of the arms, a ratio of the length of the anchoring arm to lengths of each of the chord recruiting arms when measured along the center of each of the arms from the base of the arm to the tip of the arm is greater than 2:1.
In some applications, the valve frame further includes chord-recruiting arms that are configured to extend from the valve-frame body at circumferential regions corresponding to the anterior leaflet and the posterior leaflet of the native tricuspid valve, and the valve frame does not include any arms extending from the valve-frame body at a circumferential region corresponding to the septal leaflet of the native tricuspid valve
In some applications, in a non-radially-constrained configuration of the valve frame, the chord-recruiting arms encompass less than 80 percent of a circumference of the valve-frame body.
In some applications, in the non-radially-constrained configuration of the valve frame, the chord-recruiting arms encompass more than 40 percent of the circumference of the valve-frame body.
In some applications, in a non-radially-constrained configuration of the valve frame, the valve frame does not include any chord-recruiting arms extending from the valve-frame body around at least 20 percent of a circumference of the valve-frame body.
In some applications, in the non-radially-constrained configuration of the valve frame, the valve frame does not include any chord-recruiting arms extending from the valve-frame body around at least 30 percent of the circumference of the valve-frame body.
In some applications, the chord-recruiting arms are configured to extend from a longitudinal location along the valve-frame body and, in a non-radially-constrained configuration of the valve frame, at the longitudinal location along the valve-frame body, the valve frame does not include any chord-recruiting arms around at least 20 percent of a circumference of the valve-frame body.
In some applications, in the non-radially-constrained configuration of the valve frame, at the longitudinal location along the valve-frame body, the valve frame does not include any chord-recruiting arms around at least 30 percent of a circumference of the valve-frame body.
In some applications, the valve-frame body includes a ventricular portion configured to be deployed in a right ventricle of the subject, and the chord-recruiting arms are configured to extend from a distal end of the ventricular portion of the valve-frame body.
The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:
Reference is now made to
Typically, tricuspid valve frame 22 is made of a shape-memory material 40 (e.g., a shape-memory alloy, such as nitinol and/or copper-aluminum-nickel), which is covered on one or both sides with a covering material 42, e.g., a fabric and/or a polymer (such as expanded polytetrafluoroethylene (ePTFE), or woven, knitted and/or braided polyester). Typically, the shape-memory material of the valve frame is shaped into a stent-like structure that comprises struts and/or cells of the shape-memory material. The covering material is typically coupled to the shape-memory material via stitches.
Typically, in a non-constrained configuration of prosthetic tricuspid valve frame 22, chord-recruiting arms 30 extend radially from a portion of valve-frame body 32 that is configured to be placed within the subject's ventricle. For some applications, in a non-radially-constrained configuration of the valve frame, the chord-recruiting arms encompass more than 40 percent of the circumference of the valve-frame body (e.g., more than 60 percent of the circumference of the valve-frame body), and/or less than 80 percent of the of the circumference of the valve-frame body (e.g., less than 70 percent of the circumference of the valve-frame body). Typically, the chord-recruiting arms are configured to be disposed at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve, and are configured to recruit the chords of the aforementioned leaflets, as described in further detail hereinbelow. Typically, the chord-recruiting arms are configured to extend radially from the valve-frame body, in addition to extending axially from a ventricular end of the valve-frame body (i.e., the end of the valve-frame body that is configured to be placed within the ventricle) toward an atrial end of the valve-frame body (i.e., the end of the valve-frame body that is configured to be placed within the atrium). Further typically, the chord-recruiting arms curve around the outside of the valve-frame body in a given circumferential direction of curvature (i.e., clockwise or counterclockwise). For some applications, the chord-recruiting arms are configured to have concavely rounded leading edges facing in the given circumferential direction.
Typically, there are no chord-recruiting arms disposed at a circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve. For example, the valve frame may include no chord-recruiting arms (or any portions thereof) around at least 20 percent (or at least 30 percent) of the circumference of the valve-frame body, in a non-radially-constrained configuration of the valve frame. For some applications, in the non-radially-constrained configuration of the valve frame, the valve frame does not include any arms (or any portions thereof) around at least 20 percent (or at least 30 percent) of the circumference of the valve-frame body, in a non-radially-constrained configuration of the valve frame. (As noted above, the chord-recruiting arms typically curve around the outside of the valve-frame body. For some applications, at the longitudinal location along the valve-frame body from which the chord-recruiting arms extend from the valve frame body (e.g., at the distal end of the ventricular portion of the valve-frame body) the valve frame includes no chord-recruiting arms (or any arms, or any portions thereof) around at least 20 percent (or at least 30 percent) of the circumference of the valve-frame body. However, owing to the curvature of the chord-recruiting arms around the outside of the valve-frame body, at a different location along the valve-frame body, the chord-recruiting arms may extend around a greater portion of the circumference of the valve-frame body.) For some applications, at the circumferential region of the valve frame corresponding to the septal leaflet of the native tricuspid valve, anchoring arm 28 extends radially from the portion of valve-frame body 32 that is configured to be placed within the subject's ventricle, as shown in
Typically, prosthetic tricuspid valve frame 22 is delivered to the native tricuspid valve, using a delivery catheter 50 (shown in
It is noted that the term “distal” and related terms, when used with reference to a device or a portion thereof, should be interpreted to mean an end of the device or the portion thereof that, when inserted into a subject's body, is typically further from the location through which the device is inserted into the subject's body. The term “proximal” and related terms, when used with reference to a device or a portion thereof, should be interpreted to mean an end of the device or the portion thereof that, when inserted into a subject's body, is typically closer to the location through which the device is inserted into the subject's body. It is further noted that the enlarged portions of
Reference is now made to
Typically, anchoring arm 28 and chord-recruiting arms 30 are released from their radially constrained configurations while a portion of the valve frame from which the arms extend (which is typically ventricular portion 34) is still maintained in a radially-constrained configuration, as shown in
As described in the Background section, the tricuspid valve includes three leaflets: the septal leaflet, the anterior leaflet, and the posterior leaflet. Each of the valve leaflets is attached to the tricuspid valve annulus, which defines the tricuspid valve orifice. The leaflets are connected to papillary muscles within the right ventricle, by chords. Typically, the native tricuspid valve apparatus is structured such that chords 70 extending to the anterior leaflet from the anterior papillary muscle as well as chords 72 extending to the posterior leaflet from the posterior papillary muscle are relatively long and flexible, whereas chords 74 extending to the septal leaflet from the septal papillary muscle (or from the wall of the right ventricle) are relatively short and stiff. As described hereinabove, chord-recruiting arms 30 are configured to be disposed at circumferential regions corresponding to the anterior and posterior leaflets of the native tricuspid valve. Typically, upon being released from their radially-constrained configurations (i.e., the stage of the deployment shown in
Typically, subsequent to anchoring arm 28 and chord-recruiting arms 30 being deployed among respective sets of chords (and while anchoring arm 28 and chord-recruiting arms 30 are still in their chord-deployment configurations), at least a portion of the valve frame is rotated. For some applications, the valve frame is rotated in the circumferential direction in which anchoring arm 28 and chord-recruiting arms 30 circumferentially curve around the valve frame. Typically, the rotation of the valve frame causes chord-recruiting arms 30 to (a) pull the anterior and posterior leaflets radially inward toward the valve frame, and (b) twist the anterior and posterior leaflets around the valve frame, by recruiting and deflecting at least a portion of chords 70 and 72. Further typically, the rotation of the valve frame causes anchoring arm 28 to become anchored with respect to chords 74. It is noted that the septal leaflet is typically less flexible and smaller than the anterior and posterior leaflets. Therefore, the anchoring arm typically is not used to manipulate the shape of the septal leaflet in the manner in which the chord-recruiting arms are configured to manipulate the shapes of the anterior and posterior leaflets.
Subsequent to anchoring arm 28 and chord-recruiting arms 30 being deployed among respective sets of chords and the valve frame having been rotated, valve-frame body 32 (i.e., ventricular portion 34 and atrial portion 36 of the valve-frame body) is allowed to assume its non-radially-constrained configuration. For some applications, the atrial portion is allowed to assume its non-radially-constrained configuration by releasing the atrial portion from the delivery catheter, e.g., by further retracting proximal capsule portion 56. For some applications, the ventricular portion is allowed to assume its non-radially-constrained configuration by releasing the ventricular portion from the delivery catheter, e.g., by further advancing distal capsule portion 58. Alternatively, the valve frame may be housed in a delivery catheter having a different housing component (e.g., a one-piece capsule), and the release of ventricular portion 34 and atrial portion 36 of the valve-frame body from their radially constrained configurations may be modified accordingly.
For some applications, the release of the valve-frame body causes the shapes of the anchoring arm and/or the chord-recruiting arms to change from their chord-deployment configurations to configurations that are referred to herein as the “deployed configurations” of anchoring arm 28 and chord-recruiting arms 30. (It is noted that the deployed configurations of the anchoring arm and the chord-recruiting arms are typically the same as their non-radially-constrained configurations.) For example, as shown in the transition from
Reference is now made to
Reference is now made to
As described hereinabove with reference to
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present application claims priority from U.S. Provisional Patent Application 63/211,602 to Orlov, filed Jun. 17, 2021, entitled “Valve frame for prosthetic tricuspid valve,” which is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2022/055593 | 6/16/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63211602 | Jun 2021 | US |
