JP7185604B2 - Devices, medical systems, and methods for collection of chordae and/or leaflets - Google Patents

Description

RELATED APPLICATIONS This application is based on European Patent Application No. EP 13152774 and US Provisional Patent Application No. 61/756,633 entitled "A medical device and method for facilitating selection of an annuloplasty" filed on Jan. 25, 2013. implant", European Patent Application No. EP 13152770 and US Provisional Patent Application No. 61/756,649, patent application "A valve for short time replacement for taking over the function of, and /or for temporary or partial support of, a native valve in a heart”, European Patent Application No. EP 13152771 and U.S. Provisional Patent Application No. 61/756,663, filed Jan. 25, 2013, “ and related to patent application "A system for cardiovascular valve repair", filed Jan. 25, 2013, European Patent Application No. EP 13152768 and U.S. Provisional Patent Application No. 61/756,670. . The above application is incorporated herein by reference in its entirety for all purposes.

FIELD OF THE INVENTION The present invention relates generally to medical devices, as well as tools and methods, for the improvement of heart valves, such as mitral, aortic, or tricuspid valves. More specifically, the present invention provides a medical system for the rapid replacement, support, and/or repair of tissue valves, chordae tendineae and/or tendons to hold and/or stabilize a prosthetic valve in a desired position. or to instruments for collecting and placing valve leaflets and methods of delivering prosthetic valves for short-term replacement of heart tissue valves.

2. Description of the Prior Art During cardiac surgery, the heart is frequently stopped and not perfused, so it is important to reduce the time used for valve replacement and repair.

Therefore, during repair or replacement, it would be very useful to have a prosthetic valve that temporarily replaces the tissue valve being repaired or replaced.

Further, the emphasis is on reducing the amount of time to replace and/or repair valves, so there is not much time to make decisions, prepare for and/or perform surgical/medical interventions. Therefore, it would also be useful to have more time to make decisions regarding the preparation and/or execution of surgery or medical intervention. This is important, especially as it leads to an improved quality of replacement or repair.

The use of prosthetic valves was disclosed in US20070219630 A1. However, a temporary valve is placed away from the mitral valve, as seen, for example, in FIG. 5 and [0129] in this document. Further, as seen at [0075] of this document, a mitral valve isolation unit is required for proper function. Further, in the embodiments described herein, flow is directed through the conduits (see, eg, conduits 130, 140, 330, 340, 430, 440), thus reducing the tissue valve. Through, not oriented.

Therefore, the structure of the temporary valve function as a whole is rather complicated. Furthermore, since the prosthetic valve is placed remotely from the tissue valve, it cannot utilize parts of the tissue valve, eg for positioning and fixation of the prosthetic valve.

In WO2012/095159 A2, a ring prosthetic valve is disclosed for permanently replacing an atrioventricular heart valve comprising an annulus to which the leaflets are anchored for insertion into the annulus of the heart. ing.

In US 2007/255396 A1 a girdle is disclosed for encircling the chordae tendinae of a heart valve.

In US 2007/038293 A1 an apparatus and method for endoscopic annuloplasty is disclosed. The opposing leaflets may be temporarily grasped and held in place prior to permanent union. A replacement valve is not disclosed in US2007/038293 A1.

Therefore, it can be useful to have a temporary valve that is of simple and cost effective construction. It may further be useful to have a means for quick and easy immobilization and stabilization of prosthetic valves for temporary use. Additionally, it may be useful to have a means for quick and/or easy temporary replacement of a tissue valve. Additionally, it may be useful to have a means for quick and easy positioning of a temporary prosthetic valve. Additionally, it may be useful to have means for collecting and positioning the chordae tendineae to hold and/or stabilize the prosthetic valve in a desired position.

Accordingly, improved systems or devices, particularly systems or devices for tissue valve repair and/or replacement that allow for increased flexibility and cost effectiveness, would be useful.

Accordingly, examples of the present invention preferably, in accordance with the appended claims, by providing a medical system, an apparatus for collecting chordae tendineae, and a method, may be applied to the art, such as the foregoing alone or in any combination thereof. Seek to mitigate, alleviate or eliminate one or more defects, shortcomings or problems in the field.

According to the disclosed aspects, devices, medical systems, and methods of delivery thereof for collection of chordae and/or leaflets are disclosed, thereby providing rapid and easy replacement of tissue valves, rapid replacement of temporary prosthetic valves. Easy positioning and improved quality of tissue valve repair and/or replacement can be achieved.

According to one aspect of the disclosure, a medical system for rapid replacement and repair of tissue valves is provided. Systems include prosthetic valves and devices for collecting and positioning chordae and/or leaflets to hold and/or stabilize the prosthetic valve in a desired position. The device includes a unit for grasping multiple chordae and/or leaflets.

According to another aspect of the disclosure, a device is provided for collecting and positioning chordae and/or leaflets to hold and/or stabilize a prosthetic valve in a desired position. The device includes a unit for grasping multiple chordae and/or leaflets.

According to yet another aspect of the disclosure, a method of delivering a prosthetic valve for rapid replacement of a tissue valve, such as a mitral or aortic valve in the heart, is provided. The method includes positioning a prosthetic valve within a tissue valve. The method further includes pulling a plurality of chordae and/or leaflets toward the prosthetic valve for fixation of the prosthetic valve. The method also includes placing a clip to surround the prosthetic valve and/or to maintain the chordae and/or leaflets in place toward the prosthetic valve. The method can also include obtaining trans-apical access to the heart. Additionally, the method may include advancing a catheter into the left ventricle of the heart via a transapical route. Alternatively, the method may include advancing a catheter into the ascending aorta of said heart (12) via the aortic pathway. Further, the method includes passing the catheter at least partially through the tissue valve. Additionally, the method may include removing the catheter.

Further examples of the disclosure are defined in the dependent claims, wherein features of the second and subsequent aspects of the disclosure relate to the first aspect mutatis mutandis.

Some examples of the present disclosure provide more time to make decisions about surgical procedures.

Some examples of the present disclosure provide more time to prepare for surgery.

Some examples of the present disclosure provide more time for performing surgery or for medical interventions.

Some examples of the present disclosure provide for quality improvement of tissue valve repair or replacement.

Some examples of the present disclosure provide for simple and/or reliable temporary valve functionality.

Some examples of the present disclosure provide that the tube does not interfere with annuloplasty

Some examples of the present disclosure provide for secure fixation of temporary valves.

Some examples of the present disclosure provide quick and/or easy replacement of tissue valves.

Some examples of the present disclosure provide for quick and/or easy positioning of temporary valves.

Some examples of the present disclosure provide that simple and/or rapid clip deployment is enabled.

Some examples of the present disclosure provide for quick and easy collection of chordae tendineae.

Some examples of the present disclosure provide for quick and easy fixation of temporary valves.

Some examples of the present disclosure provide quick and easy tightening to minimize paravalvular leakage.

Some examples of the present disclosure provide a less error-prone procedure and thus quick and easy fixation of the valve.

Some examples of the present disclosure provide for secure fixation of the valve and the chordae tendineae.

Some examples of the present disclosure allow for accurate positioning of anatomically correct implants or valves.

Some examples of the present disclosure provide that procedures or surgeries are performed with high precision.

Some examples of the present disclosure provide facile and/or minimally invasive delivery methods.

Some examples of the present disclosure provide for quick and easy collection of chordae tendineae.

Some examples of the present disclosure provide a quick and easy method of delivering, positioning and/or securing a temporary valve from outside the patient's body.

Some examples of the present disclosure provide for secure fixation of the temporary valve and the chordae tendineae.

Some examples of the present disclosure enable beating heart surgery.

Some examples of the present disclosure provide for reduced leakage.

Some examples of the present disclosure provide for minimizing reflux during beating heart surgery, for example.

The term "comprises/comprising," as used herein, is taken to identify the specified feature, integer, step, or element, but not one or more other features, integers, steps, It should be emphasized that nothing precludes the presence or addition of elements or groups thereof.

These and other aspects, features, and advantages of which examples of the invention are possible will be apparent and apparent from the reference made to the following description of examples of the invention, the accompanying drawings.

1 is a schematic cross-sectional view of a patient with a heart; FIG. 1 is a schematic perspective view of mitral and aortic valves; FIG. 1 is a schematic cross-sectional view of a mitral valve; FIG. 1 is a schematic cross-sectional view of a mitral valve with a catheter inserted into the left ventricle; FIG. 1 is a schematic cross-sectional view of an aortic valve with a catheter inserted into the aortic arch and partially into the ascending aorta; FIG. 1 is a schematic cross-sectional view of a mitral valve with a catheter partially in the left atrium; FIG. 1 is a schematic cross-sectional view of an aortic valve with a catheter partially in the ascending aorta; FIG. 1 is a schematic cross-sectional view of a mitral valve with a valve delivered; FIG. 1 is a schematic cross-sectional view of an aortic valve with a valve being delivered; FIG. 1 is a schematic cross-sectional view of a mitral valve with a valve for short-term replacement of the mitral valve; FIG. 1 is a schematic cross-sectional view of an aortic valve with a valve for short-term replacement of an aortic valve; FIG. 1 is a schematic illustration of the valve principle for short-term replacement of a biological valve; FIG. 1 is a schematic illustration of the valve principle for short-term replacement of a biological valve; FIG. 1 is a schematic illustration of the valve principle for short-term replacement of a biological valve; FIG. Fig. 10 is a schematic perspective view of a collection unit for collecting and positioning the chordae tendineae towards the valve; FIG. 10 is a schematic diagram of a clip used to secure the valve; 1A-1D are perspective views of various collection units for collecting and placing chordae tendineae toward a valve; 1A-1D are perspective views of various collection units for collecting and placing chordae tendineae toward a valve; Fig. 2 is a perspective view of a collection unit for collecting and placing chordae tendineae toward the valve, the unit including two hooks, arms or balloons; Fig. 2 is a perspective view of a collection unit for collecting and placing chordae tendineae toward the valve, the unit including two hooks, arms or balloons; FIG. 4 is a schematic perspective view in partial cross-section showing contraction of the chordae tendineae; FIG. 4 is a schematic perspective view in partial cross-section showing contraction of the chordae tendineae;

Description of Preferred Examples Specific examples of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the examples set forth herein. Rather, these examples are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the examples illustrated in the accompanying drawings is not intended to be limiting of the invention. In the figures, like numbers refer to like elements.

The following description focuses on examples of the present disclosure applicable to heart tissue valves, and in particular to mitral and aortic valves. However, it should be understood that the present disclosure is not limited to this application, but may also be applied to many other tissue valves, including, for example, tricuspid or pulmonary valves.

FIG. 1A illustrates a patient (10) with a heart (12) shown in cross-section including left ventricle (14) and right ventricle (16). The concepts of the present disclosure are suitable, for example, for application to the mitral valve (18), which supplies the left ventricle (14) or the aortic valve (34). The tricuspid valve (15) and pulmonary valve (17) are also shown in FIG. 1A. A native mitral valve (18), also shown in FIG. there is The leaflets 22 and 24 are for adhesion by chordae tendinae, i.e. chordae or chords (26, 28), extending upward from their respective papillary muscles (30, 32). supported. Blood enters the left ventricle 14 through the mitral valve (18) and is expelled during contraction of the heart 12 through the aortic valve 34. Aortic valve 34 controls blood flow to the aorta and organs connected to the aorta. It will be appreciated that the present disclosure may also be applicable to tricuspids (15).

Figure 2 is a cross-sectional view of the mitral valve (18) and surroundings; left atrium (44), left ventricle (14), chordae tendineae (26, 28) and mitral valve (18) are visible in this view. be able to.

FIG. 3A shows a catheter 310 that is utilized to deliver a valve for short term replacement of a biological valve such as the mitral valve (18). Catheter 310 may be inserted into left ventricle 14 of the heart in any known manner. Catheter 310 is inserted via a transapical route in some instances. In these examples, trans-apical access to the heart is obtained and the catheter 310 will be advanced to the left ventricle 14 of the heart via the trans-apical route.

Once the catheter is in the left ventricle (14), it is advanced so that it is at least partially passed through the mitral valve (18) and partially into the left atrium, as illustrated in FIG. 4A. be done. Catheter 310 may be the delivery system for all instruments used during the procedure. Thus, catheter 310 may also be utilized for delivery of chordae collectors, commissure locating tools, and/or annuloplasty devices for long-term use. A short-term replacement valve 502, which may be a prosthetic valve, is then positioned inside the native mitral valve (18). This is shown in FIG. 5A. To facilitate delivery of valve (502) and allow positioning of valve (502), valve (502) may be collapsible for delivery and/or expandable after delivery. This may be accomplished through the use of at least partially flexible valves. As an example, the flange of valve 502 may be flexible during delivery. Once the valve 502 is inside the tissue valve, multiple chordae tendineae may be grouped together and pulled toward the valve (502) for fixation of the valve (502).

Grouping multiple chordae tendineae is done in some instances to create a temporary space between at least one chordae tendineae and the ventricular wall of the heart. Within this temporary space, an annuloplasty device may be passed for delivery. Thus, by grouping multiple chordae tendineae, additional space may be created, for example, between at least two chordae tendineae and the ventricular wall of the heart. Insertion of the annuloplasty device preferably occurs after the valve (502) is positioned through which the annuloplasty device may be advanced into position through the additional space.

Multiple chordae may be brought together by rotation or twisting of valve (502) in some examples. Rotation of the valve (502) to gather the chordae tendineae is preferably specified in one direction, such as counter-clockwise rotation. Rotation of valve (502) may be accomplished by rotating the catheter. As an example, a biaxial steerable catheter (5) may be used to effect rotation of valve (502).

A clip may then be placed around valve (502) and/or to keep the chordae tendineae in place toward valve (502). In some instances, the clip is pushed out of catheter (310) and put in place by an extruder or pusher catheter. Alternatively or additionally, clips may be delivered by specialized clip guide tubes. Catheter (310) may then be removed or utilized for insertion of further implants or devices, such as an annuloplasty device. The valve (502) may remain inside the biological valve during positioning of the annuloplasty device. Once the annuloplasty device is inserted, positioned and secured for permanent implantation, the temporary, short-term valve (502) is removed.

FIG. 3B shows a catheter 310 that has been utilized to deliver a valve for short term replacement of a biological valve such as the aortic valve 34 . Catheter 310 may be inserted into ascending aorta 52 via the aortic arch. In these examples, the catheter enters transfemorally from the groin and enters the ascending aorta 52 at least partially through the aorta, eg, for valve delivery at the aortic valve 34 .

Once the catheter is in the ascending aorta (52), it is advanced so that it is at least partially threaded through the aortic valve 34 and partially into the left atrium (14), as illustrated in FIG. 4B. be done. Catheter 310 may be the delivery system for all instruments used during the procedure. Accordingly, catheter 310 may also be utilized for delivery of chordae harvesters, commissure locating tools, and/or annuloplasty devices for long-term use. A valve 502 for short-term replacement, which may be a prosthetic valve, is then positioned inside the native aortic valve (34). This is illustrated in FIG. 5B. To facilitate delivery of valve (502) and allow positioning of valve (502), valve (502) may be collapsible for delivery and/or expandable after delivery. This may be accomplished through the use of at least partially flexible valves. As an example, the flange of valve 502 may be flexible during delivery. Once the valve 502 is inside the tissue valve, multiple chordae tendineae may be gathered and pulled toward the valve (502) for fixation of the valve (502).

Grouping multiple chordae tendineae is done in some instances to create a temporary space between at least one chordae tendineae and the ventricular wall of the heart. Within this temporary space, an annuloplasty device may be passed for delivery. Thus, by grouping multiple chordae tendineae, additional space may be created, for example, between at least two chordae tendineae and the ventricular wall of the heart (12).
Through additional space, the annuloplasty device (30) may be advanced into position

Insertion of the annuloplasty device (30) preferably occurs after the valve (502) is positioned. Multiple chordae may be brought together by rotation or twisting of valve (502) in some examples. Rotation of the valve (502) to gather the chordae tendineae is preferably specified in one direction, such as counter-clockwise rotation. Rotation of valve (502) may be accomplished by rotating catheter (5). As an example, a biaxial steerable catheter (5) may be used to effect rotation of valve (502).

A clip may then be placed around valve (502) and/or to keep the chordae tendineae in place toward valve (502). In some instances, the clip is pushed out of catheter (310) and put in place by an extruder or pusher catheter. Alternatively or additionally, clips may be delivered by specialized clip guide tubes. Catheter (310) may be removed or alternatively utilized for insertion of further implants or devices, such as an annuloplasty device. The valve (502) may remain inside the biological valve during positioning of the annuloplasty device. Once the annuloplasty device is inserted, positioned and secured, the valve (502) is removed.

The valve (502) shown in FIGS. 6A and 6B is for short-term replacement of a heart tissue valve, and the valve 502 may be positioned through the tissue valve upon implantation. Valve (502) comprises an at least partially collapsible and/or at least partially expandable tube (602). Further, valve (502) comprises a flange (604). Flange (604) may be flexible during delivery, preferably becoming somewhat rigid once valve (502) is implanted. Flange (604) prevents migration of valve (502) from locations such as the left atrium to left ventricle (14) if the valve is of the mitral valve (18) and prevents the valve from migrating from the aortic valve (14), for example. block movement of the valve (502) from a location, for example, from the ascending aorta to the aortic arc.

In some examples, valve (502) is a one-way valve that includes a tube (602) having an inlet side (704) and an outlet side (706). This is illustrated in Figures 7A-C. Tube (602) may be flexible. This may be advantageous as the use of flexible tubing prevents interference between tubing (602) and other annuloplasty devices. Alternatively, tube (602) may be rigid, or at least somewhat rigid. Valve (502) may further comprise a flexible inner sleeve (702) attached to inlet side (704) of tube (602) and positioned inside tube (602). This is shown in FIG. 7A. Flexible inner sleeve (702) may be made of a flexible material such as rubber. In FIG. 7A, the pressure inside tube (602) is similar to the pressure on the inlet side (704) of tube (602). Thus, the flexible inner sleeve (702) is more or less directed against the interior of the sleeve (702) bordering the inlet side (704) as against the outside of the flexible inner sleeve (702) bordering the outlet side (705). It has more or less the same pressure, thus leaving the valve partially open. In FIG. 7B, the pressure inside the tube (602), the pressure outside the flexible inner sleeve (702), and the pressure at the left ventricle (14) are equal to the pressure at the entrance of the tube (602), the flexible inner sleeve ( 702) and the pressure inside the tube (602) increased to be greater than the pressure in the left atrium (44). When the pressure inside the tube (602) becomes greater than the pressure at the tube inlet and/or outside it, the valve (502) closes with the flexible inner sleeve (702) contracting together. In FIG. 7C, the pressure inside tube (602) and the pressure outside flexible inner sleeve (702) are the pressure at or outside the inlet of tube (704) and the pressure at the inlet of flexible inner sleeve (702). less than the internal pressure. When the pressure inside the tube (602) becomes less than the pressure at the inlet of the tube or outside it, the valve (502) and flexible inner sleeve (702) open. Thus, a simple yet reliable replacement valve is obtained by constructing the valve (502) as illustrated in FIGS. 7A-7C. A flange (708) can also be seen in FIG. 7A. Flange 708 may be expandable. In one example, flange (708) is an expandable balloon.

FIG. 8A shows an example where the collection unit (802) is used to collect and place the chordae tendineae toward the valve (502). Collection unit (802) may form one integral part with tube (602). Alternatively, collection unit (802) may be attachable to or attached to tube (602). In some examples, collection unit (802) comprises a single arm or a single hook. Alternatively or additionally, the collection unit (802) comprises a ring and/or a fluid-filled balloon. A collection unit (802) comprising a fluid-fillable or fluid-filled balloon (804) is shown in FIG. 8B. The collection unit (802) comprises a single arm in addition to a fluid-fillable or fluid-filled balloon (804).

In some examples, valve (502) comprises a collection unit (802) for collecting and placing chordae toward valve (502). The valve may be fixed, held and/or stabilized in a desired position by collecting and placing the chordae tendineae toward the valve (502). Thus, secure fixation of valve (502) may be achieved.

Through the use of the collection unit (802), quick and easy replacement of the tissue valve can be achieved. Furthermore, quick and easy positioning of the temporary valve may be obtained. Therefore, use of the collection unit provides more time to make decisions related to surgery, more time to prepare for surgery, and/or more time to perform surgery or medical intervention. May contribute to giving. Therefore, the overall performance of valve replacement or repair may be improved. Chordal valves, along with the shape of the valve (502) and accurate sizing of the valve (502), as a properly sized valve anchored by the chordae does not exert pressure against any ventricular wall. It may be convenient to fix the . Hence there is no damage to the ventricular wall. There may be a small leak outside valve (502), but this may be acceptable for short periods of time, such as minutes, hours, or days.

The valve may therefore, in certain instances, comprise a collection unit for collecting and placing the chordae tendineae towards the valve. The valve can thus be fixed, held and/or stabilized in a desired position by means of the collecting unit and by placing the chordae tendineae towards said valve. In one example, the collection unit comprises clips, and the chordae and/or leaflets are held in place towards the valve by said clips. The clip may form a helix. The clip, especially if it is helical, may be integral with or connected to the collection unit and is not a separate piece. Accordingly, in some examples, collection unit (802) may comprise a clip. FIG. 9 illustrates such a clip (902). The chordae tendineae are held in place toward valve (502) by clips (902). Clip (902) may be formed as a ring or ring-like structure. Alternatively, clip (902) may be formed or shaped as a spiral. Clip (902) can thereby be easily rotated into place. Rotation is preferably done with the valve when a collection unit, such as a clip, is integrated with the collection unit, especially if it is helical. Chordae and/or leaflets are kept in place towards the valve by the collection unit and secured by the clip. This may be advantageous as it allows for simple and/or rapid placement of clip (902). Furthermore, a secure fixation, simple and/or quick placement of the clip is made possible. Alternatively, if the clip is a separate piece, especially if it is helical, and is not integral with or connected to the valve, the collection unit may rotate separately into place. . Clips can then be applied to the collection unit for the later fixation in place at the chordae and/or leaflets.

FIG. 10 illustrates valve (502) having a collection unit for collecting and placing chordae tendineae toward valve (502), according to some examples. In these examples, the collection unit is shaped as a ring or ring-like structure. The ring-like unit (1002) may be extended to a rod-like structure for delivery and convertible to a ring-like structure for delivery or implantation. Therefore, it may be advantageous to have the collection unit shaped as a ring, as it facilitates delivery.

FIG. 11 illustrates valve (502) having a collection unit for collecting and placing chordae tendineae toward valve (502), according to some examples. In these examples, the collection unit is a fluid-filled balloon (1102). The fluid-filled balloon (1102) may be ring-shaped. The use of a fluid-filled balloon (1102) as a collection unit, as the use of a balloon facilitates delivery and the fluid may be used to stabilize the balloon and/or provide some stiffness to the balloon. Use may be convenient. In one example, the balloon is filled with fluid during or after delivery with a tissue valve.

FIG. 12A shows a collection unit for collecting and placing chordae tendineae toward valve (502), according to some examples. In these examples, the collection unit comprises two hooks (802, 1202) or arms. Alternatively, the collection unit comprises multiple (such as four) hooks or arms. The hooks or arms are preferably positioned equidistantly around the valve (502), ie the hooks or arms are preferably positioned equidistantly and externally along the valve (502). A collection unit including two fluid-fillable or fluid-filled balloons (804, 1206) is shown in FIG. 12B. The collection unit comprises two arms in addition to a fluid-fillable or fluid-filled balloon (804, 1206). Alternatively, the chordae collection unit comprises multiple (eg, four) fluid-fillable or fluid-filled balloons. The fluid-fillable or fluid-filled balloons are preferably positioned equidistant around the valve (502), i. are placed externally equidistant along.

In some examples, the collection unit collects and positions the chordae toward valve (502) during rotation of valve (502). The rotation is preferably counterclockwise rotation. Rotation of valve (502) may be actuated by rotating a catheter, such as a dual axis steerable catheter. A quick and easy collection of the chordae tendineae can thus be achieved. Furthermore, quick and easy fixation of the valve can be achieved. Additionally, with a steerable catheter, rapid and easy collection of the chordae tendineae from outside the patient's body can be accomplished. Furthermore, by specifying a direction of rotation, such as clockwise or counterclockwise, a less error-prone procedure and thus a quicker and easier fixation of the valve may be obtained. Additionally, secure fixation of the valve (502) and chordae can be achieved.

In some examples, valve (502) comprises a collection unit for collecting and placing leaflets toward valve (502). In these examples, valve (502) may be fixed, held, and/or stabilized in a desired position by collecting and positioning leaflets toward valve (502). In one example, the valve (502) is made by collecting and placing the leaflets toward the valve (502) and by collecting and placing the chordae tendineae toward the valve (502). is fixed, held and/or stabilized in position. In some examples, the valve comprises a collection unit for collecting and placing the chordae and leaflets towards the valve (502).

Figures 13A and 13B illustrate contraction of the chordae tendineae. FIG. 13A illustrates retraction of the chordae tendineae by collection units including hooks, arms, or wires. A first end of the steerable catheter or wire (1310) exits side lumens (1302) of the delivery catheter (310). Steerable catheter (1310) is then moved and manipulated by the user to encircle chordae tendineae (1340) without touching any ventricular wall (1320). As the end of catheter (1310) is advanced and/or rotated, it moves radially away from delivery catheter (310) and toward ventricular wall (1320).
Once the catheter (1310) has encircled all the chordae tendineae (1340) and 360 degree coverage of the space is achieved, the steering catheter or end unit of the wire (1310) is moved, It brings together the chordae (1340). The movement may involve rotation of the catheter or valve (502), where the curvature of the end of the catheter that grips the chordae tendineae pulls them together towards the valve. The delivery catheter (310) is held stationary during the entire deployment of the steerable catheter or wire (310).

FIG. 13B illustrates contraction of the chordae (1340) by a collection unit comprising two fluid-fillable or fluid-filled balloons. Delivery catheter (310) has two secondary lumens, which are equidistant (ie, 180 degrees apart) around delivery catheter (310). Two balloon catheters (1330, 1332) exit secondary lumens of delivery catheter (310). The balloon catheters (1330, 1332) are then manipulated and moved past the chordae tendineae (1340) towards the ventricular wall (1320).
Once the two balloon catheters are in position between the ventricular wall (1320) and the chordae tendineae (1340), the balloons may be inflated or filled with fluid. When the balloon is inflated or filled with fluid, it fills the space between the ventricular wall (1320) and the chordae tendineae (1340), pushing the tendons away from the ventricular wall toward the center and toward each other. Pushing the chordae (1340), ie the balloon traps the chordae tendineae (1340), tightens the tissue valve and brings the chordae tendineae (1340) towards the delivery catheter (310). The surface of the balloon is provided with grooves that form hollow channels when the balloon is fully inflated or filled with liquid. These channels can then guide rings or replacement valves during deployment. Described below are medical systems for short-term replacement and repair of tissue valves. The medical system includes a valve (502). Valve (502) in these examples is a prosthetic valve. Additionally, the medical system includes devices for collecting and positioning the chordae tendineae to hold and/or stabilize the prosthetic valve in the desired position. The device includes a unit for grasping multiple chordae and/or leaflets. Quick and easy replacement of tissue valves can be accomplished with the medical system. Furthermore, quick and easy positioning of the temporary prosthetic valve can be achieved. Additionally, use of the medical system provides more time to make decisions related to surgery, more time to prepare for surgery, and/or more time to perform surgery or medical intervention. may contribute to that.
Overall performance, eg valve replacement, may thus be improved.

In some instances, the medical system includes a steerable catheter for delivering a prosthetic valve; an annuloplasty device (for performing annuloplasty, i.e., reshaping the annulus of the valve, to improve the function of the valve); with a location valve expander and/or clip to lock the chordae tendineae in position toward the prosthetic valve. This may allow quick and easy replacement of the tissue valve. Furthermore, it may allow quick and easy positioning of the temporary prosthetic valve.

Described below are devices for collecting and positioning chordae tendineae to hold and/or stabilize a prosthetic valve in a desired position. The device may be a medical device and includes a unit for grasping multiple chordae tendineae. With the device, rapid and easy replacement of tissue valves can be achieved. Furthermore, quick and easy positioning of temporary prosthetic valves may be achieved. Additionally, use of the medical system provides more time to make decisions related to surgery, more time to prepare for surgery, and/or more time to perform surgery/medical interventions. may contribute to that. Thus, for example, the overall performance of valve replacement surgery may be improved.

In some examples, the unit for grasping multiple chordae tendineae includes arms, hooks, rings, and/or fluid-filled balloons. These examples provide an easy way to grasp and/or collect the chordae tendineae.

In some instances, the prosthetic valve is collapsible for delivery. Alternatively or additionally, the prosthetic valve may be expandable after delivery. Additionally, the device may be attachable to or integratable with the prosthetic valve. Therefore, the device can be attached to or integrated with a prosthetic valve. These examples provide for easier and less invasive delivery.

In some examples, a unit for grasping multiple chordae tendineae includes a number of hooks. The number of hooks may be 3, 4 or any other suitable number. Preferably, the hooks are positioned on opposite sides of the prosthetic valve. The hooks are also equidistantly or symmetrically placed externally along the prosthetic valve.

In some instances, catheter (310) is entered through the groin and advanced transseptally to right atrium (44) via a venous route to deliver valve (502).

The medical systems described herein may be utilized for short-term replacement of tissue valves and/or for temporary use during beating heart surgery. The devices described herein may be utilized for short-term replacement of tissue valves and/or for temporary use during beating heart surgery. Valve (502) may be utilized during beating heart surgery. Thus, the system, device and/or valve (502) may enable surgery on a beating heart. In addition, valve (502) may be utilized during interventions in life saving interventions, acute leaflet and/or chordae rupture.

The system, device, and/or valve (502) may provide reduced leakage and/or minimized regurgitation during beating heart surgery, for example. Additionally, the system, device, and/or valve (502) may allow for precise positioning of the implant or valve (502) at anatomically correct locations. Further, the procedures used to deliver the valve (502) described herein allow for highly precise delivery, positioning and fixation of the temporary valve body (502).

Within this disclosure, the terms "short-time" or "short-time replacement" have been used. Short term replacement and/or repair of a biological valve is considered a temporary replacement. Such temporary replacement may be replacement that lasts for minutes, hours, or possibly up to days. Short-term replacement includes devices and methods described herein that are non-intrinsic, ie, not permanently implanted. Short-term replacement devices are intended to be removed from the body after use. Long-term replacement, as used herein, means replacement that lasts for days, weeks, months, or longer. Such long-term replacement may be performed with a device that is intended to be permanently implanted and not removable from the body, such as an endogenous annuloplasty device. The structural requirements for such devices are therefore different for short-term and long-term use. As used herein, the singular forms "a," "an," and "the" are intended to include the plural as well, unless expressly defined otherwise. The terms "includes," "comprises," "including," and/or "comprising," as used herein, refer to the specified features, integers, steps, operations, , elements and/or constituents, does not preclude the presence or addition of one or more other features, integers, steps, operations, elements, constituents and/or groups thereof. Yo. When an element is referred to as being “connected” or “coupled” to another element, it does not mean that it is directly connected or coupled to another element or to intervening elements, or that there are intervening elements. , will be understood. Further, as used herein, "connected" or "coupled" may include wirelessly connected or coupled. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Unless defined otherwise, all terms (including technical and scientific terms) used in this disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Terms, as defined in commonly used dictionaries, are to be construed to have meanings consistent with their meaning in the context of the relevant art, and are expressly defined herein as such. is not to be construed in an idealized or overly formal sense, unless defined in

The present disclosure has been described above with respect to particular examples. However, examples other than those described above are equally possible within the scope of this disclosure. Different method steps, or different sequences thereof other than those described above, may be provided within the scope of the present disclosure. Different features and steps of the disclosure may be combined in other combinations than those described. The scope of the disclosure is limited only by the appended claims.

Claims (6)

A medical system for replacement and/or repair of a bioprosthetic heart valve, comprising:
an artificial valve;
a catheter;
an extruder;
a device for collecting and positioning the chordae and/or leaflets to hold and/or stabilize the prosthetic valve;
said prosthetic valve is an elongated cylinder and is delivered by a catheter and positioned at least partially within a native heart valve;
The device
a helical clip, the helical clip comprising:
A helical clip deployable from a catheter as a separate component not integral with the prosthetic valve by an pusher configured to push the helical clip into place from the catheter, comprising:
Here, the helical clip surrounds the prosthetic valve and positions the chordae tendineae toward the prosthetic valve, thereby securing the chordae tendineae in place toward the prosthetic valve and preventing movement. , configured to retain and/or stabilize the prosthetic valve;
medical system. 2. The medical system of claim 1, wherein the helix includes at least two turns. 2. The medical system of claim 1, wherein the helix includes at least three turns. 2. The medical system of claim 1, wherein the prosthetic valve is expandable and/or collapsible. 3. The medical system of claim 1, further comprising a steerable catheter for carrying the prosthetic valve. 2. The medical system of claim 1, wherein the clip is configured to pull the chordae tendineae toward the prosthetic valve, thereby creating a space between the chordae tendineae and the ventricular wall of the heart.

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