JP5695213B2 - Apparatus and method for treating a heart valve with regurgitation - Google Patents

Description

  The present invention primarily relates to an apparatus and method for treating a dysfunctional heart valve, particularly not only supporting the leaflets under the valve as an aid in passively preventing or reducing reflux in the heart valve. , Apparatus and related methods for supporting subvalvular tissue.

  The opening and closing of the heart valve occurs mainly due to a pressure difference. For example, the opening and closing of the mitral valve is caused by a pressure difference between the left atrium and the left ventricle. During ventricular diastole, pulmonary venous return of blood returning to the left atrium causes the pressure in the atrium to be higher than the pressure in the left ventricle. As a result, the mitral valve opens and blood can flow into the left ventricle. When the left ventricle contracts during the ventricular systole, the intraventricular pressure rises above the pressure in the atrium and the mitral valve is pushed back and closed.

  If the high pressure caused by the left ventricular contraction pushes the leaflet too much, the leaflet will deflect outward and a deviation will occur. Normally, this is prevented by contraction of the papillary muscle in the left ventricle connected to the leaflet of the mitral valve by a chord. Papillary muscle contraction is concurrent with left ventricular contraction and serves to maintain a healthy mitral leaflet closed at maximum systolic pressure.

  Mitral valve dysfunction can result from a variety of etiologies. For example, mitral regurgitation can be caused by an intrinsic disease of the valve leaflets (eg, mainly due to degenerative disease in patients with mitral valve prolapse), but anatomically normal, but by tethering or annulus enlargement It can extend to functional mitral regurgitation (FMR) in which the valve is pulled. Mitral regurgitation in an endogenous disease initially occurs as a leaflet disease in the majority of patients, and then annulus enlargement occurs by the time treatment continues. Mitral regurgitation includes a high proportion of FMR patients without an intrinsic disease of the leaflets.

  Surgical correction of FMR is a concomitant annuloplasty using a small, full and rigid prosthetic annulus intended to reduce the mitral annulus diameter and enhance valve leaflet joints Is based on overcorrection. Although mitral regurgitation has been surgically proven to be completely corrected, mitral regurgitation after annuloplasty repair generally has significant recurrence (25% ). This is because the left ventricle continues to dilate or remodel, resulting in further tethering of the mitral leaflets.

  According to one aspect of the invention, an apparatus is provided for treating regurgitation of blood flow through a diseased heart valve. A diseased heart valve includes an annulus, an anterior leaflet, and a posterior leaflet. The apparatus includes a substantially annular support member and at least one sub-annular support member connected thereto. The substantially annular support member has at least a first intermediate portion, a second intermediate portion, and a rear end portion extending between the first intermediate portion and the second intermediate portion. . The posterior end is dimensioned to attach to the posterior part of the annulus of the diseased heart valve. At least one sub-annular support member is securely connected to the substantially annular support member in the first position. The at least one sub-annular support member is dimensioned to extend below the posterior and anterior cusps and to extend across or behind the at least one sub-valve structure.

  In accordance with another aspect of the present invention, an apparatus is provided for treating regurgitation of blood flow through a diseased heart valve. A diseased heart valve includes an annulus, an anterior leaflet, and a posterior leaflet. The apparatus includes a substantially annular support member, a first sub-annular support member, and a second sub-annular support member. The substantially annular support member has at least a first intermediate portion, a second intermediate portion, and a rear end portion extending between the first intermediate portion and the second intermediate portion. . The posterior end is dimensioned to attach to the posterior part of the annulus of the diseased heart valve. The first sub-annular support member is securely connected to the substantially annular support member in the first position. The second annulus support member is firmly connected to the substantially annular support member at the second position. The first sub-annular support member and the second sub-annular support member extend below at least one of the posterior leaflet and the front leaflet and traverse at least behind the at least one sub-valve structure. It is made to dimension to extend to.

  According to another aspect of the invention, a method is provided for treating regurgitation of blood flow through a diseased heart valve. A diseased heart valve includes an annulus, an anterior leaflet, and a posterior leaflet. One step of the method includes providing an apparatus that includes a substantially annular support member and at least one sub-annular support member secured thereto. The substantially annular support member includes at least a first intermediate portion, a second intermediate portion, and a rear end portion extending between the first intermediate portion and the second intermediate portion. . Next, at least one sub-annular support member extends under at least one of the posterior leaflet and anterior leaflet to prevent or substantially reduce backflow of blood flow through the diseased heart valve And a substantially annular support member is attached to the annulus of the diseased heart valve so as to extend across or behind the at least one subvalvular structure.

== Cross-reference to related applications ==
This application claims the benefit of priority of US Provisional Patent Application No. 61 / 429,543 filed Jan. 4, 2011, the subject matter of which is incorporated herein by reference.

These and other features of the present invention will become apparent to those skilled in the art to which the present invention relates upon reading the following description with reference to the accompanying drawings.
1 is a perspective view of an apparatus for treating regurgitation of blood flow through a mitral valve constructed in accordance with an aspect of the present invention. FIG. FIG. 1B is a top view of the device of FIG. 1A implanted around a diseased mitral valve. 1B is a top view of the device of FIG. 1A showing a marker to facilitate attachment of the device 10 to the mitral annulus. FIG. 1B is a side view of the apparatus of FIG. 1A. FIG. It is sectional drawing cut | disconnected by line 1E-1E of FIG. 1D. It is a top view which shows another structure of the apparatus of FIG. 1B. It is a top view which shows another structure of the apparatus of FIG. 1F. 1B is a perspective view showing an adjustment mechanism included as part of the apparatus of FIG. 1A. FIG. FIG. 1H is a side view of the apparatus of FIG. 1H showing operation of the adjustment mechanism of FIG. 1H. FIG. 2 is a top view of the apparatus of FIG. 1I illustrating the operation of the adjustment mechanism. FIG. 2 is a cross-sectional view of the human heart showing percutaneous adjustment of the device of FIG. 1J. It is sectional drawing which shows the left side of a human heart. It is a perspective view which shows another structure of the apparatus of FIG. 1A. FIG. 3B is a top view of the device of FIG. 3A implanted around a diseased mitral valve. It is a perspective view which shows another structure of the apparatus of FIG. 3A. 3D is a top view of the device of FIG. 3C implanted around a diseased mitral valve. FIG. FIG. 1B is a top view of another configuration of the device of FIG. 1A implanted around a diseased mitral valve. FIG. 4B is a perspective view of the apparatus of FIG. 4A. 5 is a cross-sectional view of the device of FIGS. 4A-4B implanted around a diseased mitral valve. FIG. FIG. 5 is a perspective view of the device of FIGS. 4A-4B implanted around a diseased mitral valve. 4D is a schematic diagram illustrating the annulus level and levels that do not reach the annulus level for the mitral valve remodeling of FIGS. 4C-4D. FIG. FIG. 4 is a perspective view showing another configuration of the apparatus of FIGS. 4A to 4B. It is a perspective view which shows another structure of the apparatus of FIG. 5A. It is a perspective view which shows another structure of the apparatus of FIG. 1A. It is a perspective view which shows another structure of the apparatus of FIG. 6A. It is a perspective view which shows another structure of the apparatus of FIG. 6A. It is a top view which shows another structure of the apparatus of FIG. 1A. FIG. 7B is a perspective view of the apparatus of FIG. 7A. 7B is a side view of the apparatus of FIGS. 7A-7B. FIG. FIG. 3 is a perspective view of a sizing device configured in accordance with another aspect of the present invention. FIG. 8B is an enlarged side view showing the distal portion of the sizing device of FIG. 8A. It is a top view of the sizing member containing the sizing apparatus of FIG. 8A. 1B is a top view of the device of FIG. 1A coupled to a delivery device or holder. FIG. 1C is an enlarged perspective view showing a portion of a delivery device or holder (FIG. 8D) coupled to the device of FIG. 1A. FIG. 7B is a perspective view showing the device of FIG. 7A implanted around a diseased mitral valve. FIG. 9B is a cross-sectional view of the apparatus of FIG. 9A. 9B is a cross-sectional view of the lower annulus posterior support member of the apparatus of FIG. 9B extending around the lower free edge of the mitral posterior leaflet. FIG. 8 is a perspective view showing another configuration of the apparatus of FIGS. 7A to 7B. FIG. 10B is a perspective view of the device of FIG. 10A implanted around a diseased mitral valve. FIG. 8 is a perspective view showing another configuration of the apparatus of FIGS. 7A to 7B. FIG. 11B is a perspective view of the device of FIG. 11A implanted around a diseased mitral valve. FIG. 8 is a perspective view showing another configuration of the apparatus of FIGS. 7A to 7B. FIG. 12B is a side view of the device of FIG. 12A. FIG. 13 is a perspective view of the device of FIGS. 12A-12B implanted around a diseased mitral valve. FIG. 8 is a plan view showing another configuration of the apparatus of FIGS. 7A to 7B. FIG. 13B is a side view of the device of FIG. 13A. FIG. 6 is a top view of an apparatus for treating regurgitation of blood flow through a tricuspid valve constructed in accordance with another aspect of the present invention. FIG. 14B is a perspective view of the apparatus of FIG. 14A. FIG. 14B is a side view of the device of FIG. 14A. FIG. 14B is a perspective view showing another configuration of the apparatus of FIG. 14A. It is a perspective view which shows another structure of the apparatus of FIG. 14A. It is sectional drawing of a human heart. FIG. 14B is a perspective view of the device of FIG. 14A implanted around a diseased tricuspid valve. It is a perspective view which shows the lower surface of the tricuspid valve of FIG. 16A. FIG. 14B is a perspective view showing another configuration of the apparatus of FIG. 14A. FIG. 17B is a perspective view of the device of FIG. 17A implanted around a diseased tricuspid valve. It is a perspective view which shows the lower surface of the tricuspid valve of FIG. 17B. It is a perspective view which shows another structure of the apparatus of FIG. 17A. It is a perspective view which shows another structure of the apparatus of FIG. 17A. FIG. 14B is a perspective view showing another configuration of the apparatus of FIG. 14A. It is a perspective view which shows another structure of the apparatus of FIG. 18A. FIG. 19 is a perspective view showing still another configuration of the apparatus of FIG. 18B.

  The present invention primarily relates to an apparatus and method for treating a dysfunctional heart valve, particularly not only supporting the leaflets under the valve as an aid in passively preventing or reducing reflux in the heart valve. , Apparatus and related methods for supporting subvalvular tissue. The present invention primarily provides a prosthetic annulus system having an annulus, a free leaflet edge and a subtissue support mechanism that prevents leaflet tethering and backflow during systole. Conveniently, the present invention corrects and corrects the height and angle of the leaflet junction to prevent leaflet tethering and to solve the problem of valve recurrent recurrence over time. Ventricular remodeling (mitral and tricuspid) is achieved simultaneously at the annulus level and not to the annulus level. As a result, the present invention can treat not only reflux (such as functional mitral regurgitation) but also reflux caused by dilated cardiomyopathy and ischemic cardiomyopathy.

  As a representative example of one aspect of the present invention, FIGS. 1A through 1E show an apparatus 10 for coping with blood regurgitation when a valve, such as a heart mitral valve 12 (FIG. 2) is diseased. As shown in FIG. 2, the mitral valve 12 is located between the left atrium 14 and the left ventricle 16 and functions to prevent backflow of blood from the left ventricle to the left atrium during contraction. The mitral valve 12 has a D-shaped annulus 18. The annulus 18 defines an opening between the left atrium 14 and the left ventricle 16 and includes an anterior portion 20 and a posterior portion 22 that face each other. The mitral valve 12 is formed by two leaflets, an anterior leaflet 24 and a posterior leaflet 26. Each of these leaflets includes an upper surface 28 and a lower surface 30 that face each other. The anterior leaflet 24 extends along the generally flat base of the D-shaped annulus 18 between two fiber triangles (not shown). The posterior leaflet 26 extends arcuately around the curved portion of the D-shaped annulus 18 of the mitral valve 12. The chords 32 and 32 'connect with the papillary muscles 38 and 38' of the left ventricle 16 between the lower free edge 34 of the anterior mitral valve leaflet 24 and the lower free edge 36 of the mitral valve leaflet 26, respectively. ing.

  Referring to FIGS. 1A-1E, the apparatus 10 includes a substantially annular support member 40 and at least one sub-annular support member. The lower annulus support member is, for example, the lower annulus rear support member 42 fixed to the support member 40. The device 10 has a three dimensional (3D) shape corresponding to the saddle shape of the mitral annulus 18. Because of this 3D shape, the device 10 can assist in the 3D shape of the mitral valve 12 during complex physiological movements associated with the cardiac cycle. This eliminates the need for valvectomy and / or annuloplasty. Because the device 10 is implanted near the mitral valve 12 (eg, within or on the annulus 18), it can help passively support the leaflets without deformation during the cardiac cycle. is there.

  The substantially annular support member 40 includes at least a first intermediate portion 44, a second intermediate portion 46, and a rear end portion extending between the first intermediate portion and the second intermediate portion. 48. As used herein, the expression “substantially annular” can be used to describe an annular support member 40 configured in a circular or semi-circular shape. Thus, the expression “substantially annular” may refer to an annular support member 40 that is fully annular, fully circular, elliptical, partially circular, C-shaped, D-shaped, U-shaped, or the like. As used herein, the expression “substantially” can be said to be complete or nearly complete in degree or degree of movement, feature, characteristic, state, structure, matter or result. For example, an annular support member 40 that is “substantially” annular will mean that the support member is completely annular or nearly completely annular. Exactly how much deviation from an absolute circle is allowed depends on the individual context in some cases. However, in general terms, it will be close to a ring so that the overall result is the same as if it were an absolute and perfect ring.

  As shown in FIGS. 1A to 1C, the substantially annular support member 40 is completely annular and includes a first intermediate portion 44, a second intermediate portion 46, a first intermediate portion, and a second intermediate portion. A rear end portion 48 extending between the first intermediate portion and the second intermediate portion, and a front end portion 50 extending between the first intermediate portion and the second intermediate portion. You may prepare. Alternatively, as shown in FIGS. 1F to 1G, the substantially annular support member 40 is partially annular and includes a first intermediate portion 44, a second intermediate portion 46, and a first intermediate portion. And a rear end portion 48 extending between the second intermediate portion and the second intermediate portion.

  The front end 50 is dimensioned to be attached to the front 20 of the mitral annulus 18 and the rear end 48 is attached to the rear 22. For example, the rear end 48, the first intermediate portion 44, and the second intermediate portion 46 form a continuous arc such that the rear end is concave with respect to the front end 50. Similarly, the front end portion 50, the first intermediate portion 44, and the second intermediate portion 46 form a continuous arc so that the front end portion is convex with respect to the rear end portion 48. As shown in FIG. 1D, the substantially annular support member 40 also includes a longitudinal axis LA. The substantially annular support member 40 may have a rigid configuration or a semi-rigid configuration.

  The apparatus 10 also includes at least one sub-annular rear support member 42 that is directly and securely connected to the substantially annular support member at the first position 52. As shown in FIGS. 1A to 3B, for example, the device 10 includes only one sub-annular rear support member 42. The sub-annular posterior support member 42 extends below or behind the mitral valve leaflet 26 and across or behind the mitral valve leaflet 26 when the device 10 is implanted over or around the mitral valve annulus 18. It is made in the size, shape and configuration as it exists. The valve structure connected to the mitral valve 12 includes a lower surface of the rear leaflet 26 such as the lower free edge 36 of the rear leaflet, a lower surface of the front leaflet 24 such as the lower free edge 34 of the front leaflet, and a chord 32 connected to the rear leaflet. A chord 32 'connected to the anterior apex, one or more papillary muscles 38 connected to the chord of the posterior apex, one or more papillary muscles 38' connected to the chord of the front apex, These combinations may be included, but are not limited to these.

  The sub-annular rear support member 42 may be a single whole sub-structure, two or more sub-sub structures, a part of a single sub-structure or two or more sub-structures. It may be made in a shape, configuration, or dimension that extends across or behind a portion. For example, the sub-annular posterior support member 42 extends below or behind the mitral valve leaflet 26 and a portion of the lower free edge 36 of the mitral valve leaflet or behind it, or the mitral valve It may be configured to extend across or behind only a portion of the lower free edge of the posterior leaflet. Further, the sub-annular posterior support member 42 may be the entire chord 32 and / or one or more papillary muscles 38 connected to the posterior mitral valve leaflet and the mitral valve posterior leaflet, or the mitral valve. It may be configured to extend across or behind a portion of the posterior apical chord. In one or both of these cases, in order to prevent or reduce restriction of movement of the mitral posterior leaflet and thus prevent or reduce backflow of blood through the mitral valve 12, The shape faithfully reflects the 3D shape of the mitral posterior leaflet 26, particularly its lower free edge 26.

  As shown in FIG. 1D, the lower annulus rear support member 42 extends from the longitudinal axis LA of the substantially annular support member 40 at an angle A and a distance D below this axis. Yes. The angle A of the lower annulus rear support member 42 is such that the lower annulus rear support member facilitates optimal leaflet jointing. In one embodiment of the invention, angle A may be between about 10 ° and about 60 ° (eg, about 30 °). Similarly, the distance D is such that the sub-annular posterior support member 42 extends below the mitral posterior leaflet 26 to facilitate optimal valve leaflet joints with the sub-annular posterior support member. .

  The annulus lower rear support member 42 may have a rigid configuration or a semi-rigid configuration. If the lower annulus rear support member 42 has a semi-rigid configuration, for example, the lower annulus rear support member may be bendable or adjustable to various positions. In addition or optionally, the annulus lower rear support member 42 may include an adjustment mechanism 54 (FIGS. 1H to 1K) for selectively adjusting its position relative to the longitudinal axis LA. As shown in FIG. 1I, the adjustment mechanism 54 is used to allow the angle A and / or distance D and / or lateral direction of the sub-annular posterior support member 42 before, during and / or after implantation of the device 10. The position LP can be selectively adjusted.

  To optimize leaflet joints, anatomical leaflet configurations, subvalvular tissue configurations (eg, chordae 32 and 32 'and papillary muscles 38 and 38'), and / or free edge leaflet joints Depending on the angle, the angle A and / or the distance D and / or the lateral position LP of the lower annulus rear support member 42 can be selectively adjusted. The lateral position LP is the relative position of the lower annulus rear support member 42 to the rear end 48 of the substantially annular support member 40 and parallel (or substantially parallel) to the longitudinal axis LA. ) A position along the axis. As shown in FIG. 1J, the adjusting mechanism 54 is operable to adjust the lateral position LP of the lower annulus rear support member 42 to a preset position (indicated by an arrow and a dotted line). For example, the device 10 may include three preset positions (indicated by “1”, “2”, “3”). It will be apparent that the adjustment mechanism 54 may be operable to adjust the angle A and / or distance D of the lower annulus rear support member 42 to a preset position.

  In one embodiment of the present invention, the adjustment mechanism 54 is a screw (e.g., ratchet-like) that is at least partially disposed within the substantially annular support member 40 and operatively connected to the lower annulus rear support member 42. ) And other actuating members 56 (FIGS. 1H and 1J). The actuation member 56 is selectively manipulated (eg, rotated, pushed, pulled, etc.) to adjust (eg, increase or decrease) the angle A and / or distance D and / or the lateral position LP of the annulus rear support member 42. Can be reduced).

  The actuating member 56 can be selectively operated by an adjuster 58 (FIGS. 1I to 1K). The configuration of the adjuster 58 depends on the point in time at which the position of the lower annulus rear support member 42 is to be adjusted. If adjustment is required during thoracotomy, for example, the adjuster 58 can be configured like a screwdriver or other similar device that can be easily held and operated by the surgeon (FIG. 1J). Alternatively, if adjustment is required after implantation of the device 10, the adjuster 58 can be configured as a catheter to allow percutaneous adjustment of the subannular posterior support member 42 (FIGS. 1I and 1K).

  In general terms, the actuating member 56 may be used under direct vision during direct cardiac surgery using percutaneous septal myocardial cauterization (FIG. 1K), using electromagnetic force (discussed below) and / or by echocardiographic guidance. Can be selectively operated. For example, after removal from cardiopulmonary bypass, the actuating member is manipulated to adjust the sub-annular posterior support member 42 (eg, under echocardiographic guidance) to achieve an optimal leaflet junction angle, thereby providing a mitral valve And / or adjuster 58 can be magnetically attached to the left of actuating member 56 and out through the left atrial wall so that tricuspid regurgitation can be eliminated. Thereafter, the magnetic force is released and the adjustment tool 58 is retracted.

  It will be appreciated that the adjustment mechanism 54 may take other configurations that allow for selective adjustment of the lower annulus rear support member 42. For example, the whole or part of the lower annulus rear support member 42 may be made of a shape memory material that can be adjusted in shape (and orientation) by selectively applying energy. If recurrent reflux of the mitral and / or tricuspid valve occurs over time, the adjustment mechanism 54 advantageously allows the sub-annular posterior support member 42 to be used without further direct cardiac surgery. You can adjust the position.

  The lower annulus rear support member 42 (FIG. 1C) includes an engagement portion 60 and an integral neck portion 62 that extends from the engagement portion to a first position 52. The engagement portion 60 is configured to contact at least one sub-valve structure and typically has an elongated S-shaped configuration. The engagement portion 60 may have a circular cross-section, may be V-shaped, may be oval or square, and may have any other geometric cross-section. The engaging part 60 may be configured in an arc shape. As shown in FIG. 1C, for example, the engagement portion 60 may be convex with respect to the rear end 48 of the substantially annular support member 40.

  The neck portion 62 is formed integrally with the engaging portion 60. The neck 62 is dimensioned to extend between, or approximately between, one of the commissures of the respective mitral leaflets 24 and 26. As such, the first location 52 is generally adjacent to one of the commissures, but this is not necessarily so. As shown in FIGS. 1B-1C, the neck 62 is disposed opposite one another, formed integrally with the substantially annular support member 40 and the engagement portion 60 (at the first position 52). It has a first end 64 and a second end 66. For example, the first end 64 of the neck 62 is formed integrally with the second intermediate portion 46 of the substantially annular support member 40.

  The whole or part of the device 10 may be made of a rigid material and can be deformed by hand, but can remain undeformed after implantation (ie when exposed to normal physiological stress). It may be made of a semi-rigid material having the following rigidity. Non-limiting examples of materials for constructing device 10 include biocompatible, medical grade metals such as metal alloys, plastics, nitinol, stainless steel, titanium, pyrolytic carbon, cobalt chrome, and the like.

  The whole or part of the device 10 may be covered with a layer 68 of biocompatible material (FIG. 1E). The layer of biocompatible material 68 may comprise a synthetic material such as DACRON, velor fabric, polyurethane, PTFE, ePTFE or heparin coated fabric. Alternatively, layer 68 may comprise biological material such as bovine or equine pericardium, co-graft, patient graft or cell seeded tissue. Layer 68 may cover the inner surface of substantially annular support member 40 and / or lower annulus rear support member 42, the outer surface of substantially annular support member and / or the lower annulus rear support member, You may wrap both the inner and outer surfaces. As shown in FIG. 1E, for example, the layer 68 may be attached to the entire outer periphery of the substantially annular support member 40. Note that layer 68 may cover any portion of device 10.

  As also shown in FIG. 1C, layer 68 may include at least one marker 70 to facilitate attaching device 10 to mitral annulus 18. The marker 70 may include a pre-formed hole for facilitating placement with the suture and / or a color mark indicating where the suture should be placed to stabilize the device 10 in vivo. . By including an additional biocompatible layer around one or more desired portions, a portion of the device 10 is placed at the height of a fiber triangle (not shown) to facilitate implantation and leaflet junctions. Note that it may be magnified or reinforced.

  At least a portion of the device 10 may be treated with one or a combination of therapeutic agents that can elute into the ventricles and / or heart tissue. The therapeutic agent may be capable of preventing a wide variety of pathological conditions including, but not limited to, arrhythmia, thrombosis, stenosis, apoptosis, inflammation. For this reason, therapeutic agents are antiarrhythmic agents, anticoagulants, antioxidants, thrombolytic agents, steroids, anti-apoptotic agents, anti-proliferative agents (ie, can prevent abnormal proliferation of epithelial cells) and / or anti-arrhythmic agents. At least one of the inflammatory agents may be included. Optionally or in addition, the therapeutic agent may be one that can treat or prevent other diseases or disease processes such as microbial infection and heart failure. In these cases, the therapeutic agent may include an antimicrobial agent (eg, an antimicrobial agent, etc.), a cardiotonic agent, a chronotropic agent, and / or a biological agent (eg, a cell or protein).

Another embodiment of the present invention is shown in FIGS. 3A-3D. The device 10 shown in FIGS. 3A to 3D is configured in the same manner as the device 10 shown in FIGS. 1A to 1I except as described below. 3A to 3D, the same reference numerals are used for the same structures as those of FIGS. 1A to 1I, but similar structures that are similar but not identical are denoted by the suffix “a”. The device _10a may be composed of any of the materials described above, and the device may include a layer 68 of biocompatible material and / or one or more therapeutic agents as also described above. Please be careful.

Figures 3A 3B, the subannular rear support member 42 _a may have a bifurcated configuration including a first engagement portion 72 and the second engagement portion 74 away from each other . The first engaging portion 72 and the second engaging portion 74 may be separated from each other by a distance D1 (FIG. 3A) and shifted in the axial direction (based on the central axis CA). In general, the distance D1 can be varied depending on factors such as the anatomy of the mitral valve and the dysfunctional state of the individual valve affected by the subject. In particular, the distance D1 can be changed to facilitate contact of the first engagement portion 72 and the second engagement portion 74 with one or more sub-valve structures. For example, the distance D1 is such that the first engaging portion 72 contacts a part of the lower free edge 36 of the mitral valve posterior leaflet 26 and the second engaging portion 74 is connected to the mitral valve posterior leaflet. It can be modified to contact a portion of the chord 32 and / or one or more papillary muscles 38.

  As shown in FIGS. 3C to 3D, the lower annulus rear support member 42 may have an arcuate and loop configuration with an opening 134 extending therethrough. The engagement portion 60 of the lower annulus rear support member 42 may have a concave shape with respect to the front end 50 of the substantially annular support member 40. Further, the engagement portion 60 of the lower annulus rear support member 42 may extend across or behind the whole or a part of at least one sub-valve structure.

Another embodiment of the present invention is shown in FIGS. 4A-4E. 10 _b shown in Figure 4E from Figure 4A, except as described below, are configured the same as the device 10 shown in FIG. 1I from Figure 1A. In FIGS. 4A-4E, the same reference numerals are used for the same structures as those of FIGS. 1A-1I, but similar structures that are similar but not identical are denoted by the suffix “b”. Device 10 _b may be constituted by any material as described above, similarly to may comprise a layer 68 and / or one or more therapeutic agents of biocompatible material as described above, it is noted.

As shown in FIGS. 4A to 4B, the lower annulus rear support member 42 _b may have a bifurcated branch configuration including a first engagement portion 72 and a second engagement portion 74 that are separated from each other. . The first engaging portion 72 and the second engaging portion 74 may be separated from each other by a distance D2 (based on the central axis CA) and shifted in the radial direction. Usually, the distance D2 can be varied depending on factors such as the anatomy of the mitral valve and the dysfunctional state of the individual valve the subject is suffering from. In particular, the distance D2 can be changed to facilitate contact between the first engaging portion 72 and the second engaging portion 74 and one or more subordinate structures. For example, the distance D2 can be defined as a chord 32 '(and / or one or more papillae) in which the first engagement portion 72 is connected to the lower free edge 34 of the mitral valve leaflet 24 and / or the mitral valve leaflet. The chord 32 (and / or 1) in contact with a portion of the muscle 38 ') and the second engagement portion 74 connected to the lower free edge 36 of the mitral valve leaflet 26 and / or the mitral valve leaflet. It can be changed to contact a part of more than papillary muscles 38 '). Two levels of ventricular remodeling can occur when device _10b is firmly implanted, as shown in FIGS. 4C-4E and described in detail below.

Another embodiment of the present invention is shown in FIGS. 5A-5B. 10 _c shown in FIG. 5B from FIG. 5A, except as described below, are configured the same as the device 10 shown in Figure 1B from Figure 1A. 5A to 5B, the same reference numerals are used for the same structures as those of FIGS. 1A to 1B, but similar structures that are similar but not identical are denoted by the suffix “c”. Device 10 _c may be composed of any material as described above, similarly to may comprise a layer 68 and / or one or more therapeutic agents of biocompatible material as described above, it is noted.

  The apparatus includes a Y-shaped or fork-shaped sub-annular support member 76. The annulus lower support member 76 includes an annulus lower front support portion 78 provided to face the lower annulus rear support portion 80. The lower annulus front support 78 and the lower rear annulus support 80 are integrally connected via a common neck 82 at a first position 52 of the substantially annular support 40 member. The first position 52 may be in either the first intermediate portion 44 or the second and 46 and may be located adjacent to the mitral valve commissure.

  As shown in FIG. 5A, the lower annulus front support part 78 and the lower annulus rear support part 80 each have a first engagement part 72 and a second engagement part 74 that are separated from each other. The first engaging portion 72 and the second engaging portion 74 may be separated from each other by a distance D1 (based on the central axis CA) and shifted in the axial direction. Alternatively, the lower annulus front support portion 78 and the lower annulus rear support portion 80 may each have an elongated loop-shaped configuration (FIG. 5B). The lower annulus front support portion 78 is separated from the lower annulus rear support portion 80 in the radial direction by a distance D2. It will be apparent that the distance D1 and / or the distance D2 can be varied to optimize leaflet junctions.

Another embodiment of the present invention is shown in FIGS. 6A-6C. 10 _d shown in Figure 6C from Figure 6A, except as described below, it is configured the same as the device 10 shown in FIG. 1I from Figure 1A. 6A to 6C, the same reference numerals are used for the same structures as those of FIGS. 1A to 1I, but similar structures that are similar but not identical are denoted by the suffix “d”. Device 10 _d may be constituted by any material as described above, similarly to may comprise a layer 68 and / or one or more therapeutic agents of biocompatible material as described above, it is noted.

As shown in FIGS. 6A to 6C, the device 10 _d has a substantially annular support member 40 and a sub-annular front and rear support member 180 firmly connected thereto. The substantially annular support member 40 is generally annular and includes a first intermediate portion 44, a second intermediate portion 46, and a rear end extending between the first intermediate portion and the second intermediate portion. The part 48 may include a front end portion 50 that faces the rear end portion and extends between the first intermediate portion and the second intermediate portion. Alternatively, the substantially annular support member 40 is partially annular and extends between the first intermediate portion 44, the second intermediate portion 46, and the first intermediate portion and the second intermediate portion. The rear end portion 48 may be included.

The front end 50 and the rear end 48 are sized to be attached to the front 20 and rear 22 of the mitral annulus 18, respectively. For example, the rear end portion 48, the first intermediate portion 44, and the second intermediate portion 46 form a continuous arc so that the rear end portion is concave with respect to the front end portion 50. . Similarly, the front end portion 50, the first intermediate portion 44, and the second intermediate portion 46 form a continuous arc so that the front end portion is convex with respect to the rear end portion 48. . Like the device 10 shown in FIG. 1D, device 10 _d substantially annular support member 40 also includes a shaft LA longitudinal. The substantially annular support member 40 may be rigid or semi-rigid.

The sub-annular anteroposterior support member 180 is located below the mitral valve anterior end 26 and the mitral valve anterior leaflet 24 and at least one sub-valve when the device 10 _d is implanted on or around the mitral annulus 18. It is sized, shaped, and configured to extend across or behind the structure. The sub-annular front and rear support member 180 is directly and securely connected to the substantially annular support member 40 at the first position 52. As shown in FIG. 6A, for example, the front and rear annulus support member 180 is directly and firmly connected to the second intermediate portion 46. Although not shown, it will be obvious that the annulus front and rear support member 180 may be directly and securely connected to the first intermediate portion 44.

  The sub-annular front and rear support member 180 includes a hook-shaped engagement portion 182 that is integrally and directly connected to the substantially annular support member 40 via the neck portion 62. The engaging portion 182 further includes a first engaging portion 184, a second engaging portion 186, and a bent portion 188 extending between the first engaging portion and the second engaging portion. Including. The first engagement portion 184 and the second engagement portion 186 each have a continuous, arcuate (or arcuate) configuration configured to extend across or behind at least one subvalve structure. Have. The first engagement portion 184 and the second engagement portion 186 may have a concave shape and a convex shape (respectively) with respect to the front end portion 50 of the substantially annular support member 40. .

  The first engaging portion 184 includes a lower surface of the posterior leaflet 26 (such as the lower free edge 36 of the posterior leaflet), a chord 32 connected to the posterior leaflet, and one or more papillae connected to the chords of the posterior leaflet. The muscles 38, combinations thereof, etc. are configured to extend across or behind the at least one subvalvular structure. The second engaging portion 186 includes the lower surface of the anterior leaflet 24 (such as the lower free edge 34 of the anterior leaflet), the chord 32 'connected to the anterior leaflet, and one or two connected to the chordae of the anterior leaflet. The papillary muscles 38 ', combinations thereof, etc. are configured to extend across or behind at least one subvalvular structure.

  The first engaging portion 184 and the second engaging portion 186 are in the same plane as viewed in the lateral direction (that is, a surface extending below or parallel to or substantially parallel to the longitudinal axis LA). They may be positioned or may be shifted from each other with respect to the central axis CA. Thus, the 1st engaging part 184 and the 2nd engaging part 186 may be located so that the same or different corresponding under-valve structure may be contacted. When the first engagement portion 184 and the second engagement portion 186 are displaced from each other, for example, the first engagement portion is provided on the lower surface of the rear leaflet 26 (for example, the lower free edge 36 of the rear leaflet). The second engagement portion may be configured to extend across or behind the chord 32 'connected to the anterior leaflet 24. Also good.

  Another configuration of the annulus front and rear support member 180 is shown in FIGS. 6B to 6C. As shown in FIG. 6B, the engaging portion 182 of the annulus lower front and rear support member 180 may have a bifurcated branch configuration including a first engaging member 190 and a second engaging member 192 that are separated from each other. Good. The first engagement member 190 and the second engagement member 192 may be separated from each other by a distance D1 (based on the central axis CA) and shifted in the axial direction. In general, the distance D1 can be varied depending on factors such as the anatomy of the mitral valve and the dysfunctional state of the individual valve affected by the subject. In particular, the distance D1 can be changed to facilitate contact of the first engagement member 190 and the second engagement member 192 with one or more sub-valve structures. As described above, the first engagement member 190 and the second engagement member 192 include the first engagement portion 184 and the second engagement portion 186, respectively.

  As shown in FIG. 6C, the engaging portion 182 of the front and rear annulus support member 180 may have an arcuate and loop configuration in which the opening 134 extends. The loop-shaped engagement portion 182 may include a first engagement member 190 and a second engagement member 192 that are joined at a common arcuate bend 194. The first engagement member 190 and the second engagement member 192 may be separated from each other by a distance D1 (based on the central axis CA) and shifted in the axial direction. In general, the distance D1 can be varied depending on factors such as the anatomy of the mitral valve and the dysfunctional state of the individual valve affected by the subject.

10 _d may additionally or optionally thereto, it may include other features as well as other features described above such as the device 10 shown in Figure 1B from Figure 1A, it will be obvious. For example, device 10 _d are adjustable mechanism 54, one of the at least one marker 70 and / or therapeutic agents for the layer 68 of biocompatible material, the device easily attached to the mitral valve annulus 18 or Combinations may be included.

Another embodiment of the present invention is shown in FIGS. 7A-7C. 10 _e shown in FIG. 7C Figures 7A, except that will be described later, it is configured the same as the device 10 shown in FIG. 1I from Figure 1A. 7A to 7C, the same reference numerals are used for the same structures as those of FIGS. 1A to 1I, but similar structures that are similar but not identical are denoted by the subscript “e”. Device 10 _e may be formed by any material as described above, similarly to may comprise a layer 68 and / or one or more therapeutic agents of biocompatible material as described above, it is noted.

As shown in FIGS. 7A-7C, the device _10e includes a substantially annular support member 40, a first lower annulus rear support member 42 ′, and a second lower annulus rear support member 42 ″. Including. The substantially annular support member 40 is completely annular and extends between the first intermediate portion 44, the second intermediate portion 46, and the first intermediate portion and the second intermediate portion. You may provide the side edge part 48 and the front side edge part 50 extended between a 1st intermediate part and a 2nd intermediate part, and facing a rear side edge part. Alternatively, the substantially annular support member 40 is partially annular and extends between the first intermediate portion 44, the second intermediate portion 46, and the first intermediate portion and the second intermediate portion. An existing rear end 48.

  The front end 50 is dimensioned to be attached to the front 20 of the mitral annulus 18 and the rear end 48 is attached to the rear 22. For example, the rear end 48, the first intermediate portion 44, and the second intermediate portion 46 form a continuous arc such that the rear end is concave with respect to the front end 50. Similarly, the front end portion 50, the first intermediate portion 44, and the second intermediate portion 46 form a continuous arc so that the front end portion is convex with respect to the rear end portion 48. As shown in FIG. 7C, the substantially annular support member 40 also includes a longitudinal axis LA. The substantially annular support member 40 may have a rigid configuration or a semi-rigid configuration.

First subannular rear support member 42 'and the second subannular rear support member 42''is, when porting device 10 _e on or around the mitral valve annulus 18, leaflet mitral valve 26, and is sized, shaped and configured to traverse or behind at least one subvalve structure. The first sub-annular rear support member 42 ′ is directly and securely connected to the substantially annular support member 40 at the first position 52, and the second sub-annular rear support member 42 ″ is A second position 84, different from the first position, is directly and securely connected to the substantially annular support member. As shown in FIG. 7A, for example, the first lower annulus rear support member 42 ′ is directly connected to the first intermediate part 44 directly, and the second lower annulus rear support member 42 ″ is The second intermediate part 46 is directly and firmly connected.

  Each of the first lower annulus rear support member 42 ′ and the second lower annulus rear support member 42 ″ are angled from the longitudinal axis LA of the substantially annular support member 40 by angles A 1 and A 2 ( In FIG. 7C), it extends down by distances D3 and D4. The angles A1 and A2 of the first lower annulus rear support member 42 ′ and the second lower annulus rear support member 42 ″ correspond to the first lower annulus rear support member and the second lower annulus support. Each member is such that it facilitates optimal leaflet jointing. In one embodiment of the present invention, the angles A1 and A2 of one or both of the first sub-annular rear support member 42 ′ and the second sub-annular rear support member 42 ″ are from about 10 ° to about It may be between 60 ° (eg about 30 °). It will be apparent that the angles Al and A2 may be the same or different. Similarly, distances D3 and D4 indicate that a portion of each of the first sub-annular back support member 42 ′ and the second sub-annular back support member 42 ″ extends below the mitral valve leaflet 26. Thus, the first and second lower annulus rear support members can facilitate optimal valve leaflet joining. It will also be apparent that the distances D3 and D4 may be the same or different.

  The first lower annulus support member 42 ′ and the second lower annulus support member 42 ″ are each configured similarly to the lower annulus rear support member 42 described above with reference to FIGS. 1A to 1B. Or they may be configured in the same way. For example, the first lower annulus rear support member 42 ′ and the second lower annulus support member 42 ″ each extend from the engagement portion 60 (FIG. 7A) to the first position 52 from the engagement portion. And an integral neck 62. Each of the engaging portions 60 of the first lower annulus rear support member 42 ′ and the second lower annulus rear support member 42 ″ has a front end portion of the substantially annular support member 40. An arcuate shape that is concave with respect to 50 may be used.

It will be appreciated that the device 10 _e may include other features such as the device 10 shown in FIGS. 1A-1B as well as those described above. For example, the device 10 _e may include one or more of an adjustable mechanism 54, a layer of biocompatible material 68, at least one marker 70 and / or a therapeutic agent to facilitate attachment of the device to the mitral annulus 18. Combinations may be included.

Another embodiment of the present invention is shown in FIGS. 8A-9C. This aspect includes a method for treating regurgitation of blood flow through a mitral valve 12 with regurgitation. Hereinafter, how Figures 7A will be described a method of the present invention using the apparatus 10 _e shown in FIG. 7B, to treat backflow of blood flow through the mitral valve with a disease, as described herein Note that a device may be used. For example, the device 10 _f shown in FIGS. 13A-13B may be used to treat an anterior mitral valve leaflet 24 that is dysfunctional (eg, limited mobility, etc.).

As described above, the device 10 _e (FIGS. 7A-7B) includes a D-shaped annular support member 40 that is saddle-shaped and that allows a 3D configuration to be attached to the mitral annulus 18. In addition, the device _10e is disposed opposite to each other, and each of the first lower annulus rear part formed integrally with the first intermediate part 44 and the second intermediate part 46 of the substantially annular support member 40, respectively. It includes a support member 42 'and a second lower annulus rear support member 42''. Although not shown in FIGS. 7A-7B, the whole or only part of device _10e (eg, substantially annular support member 40, etc.) is covered with a layer 68 of biocompatible material, such as a suture ring. It may be obvious that it may be.

In order to treat the mitral valve 12 with regurgitation, the mitral valve dimensions are first obtained to determine the optimal dimensions for the device _10e . The mitral valve 12 can be sized using a valve sizing device. Examples of valve sizing devices are known in the prior art and may include commercially available sizers such as the ATS OPEN PIVOT STANDARD SIZER series (ATS Medical, Inc. Minneapolis, Minn.). In one embodiment of the present invention, the dimensions of the mitral valve 12 are measured using the valve sizing device 86 disclosed in Navia's US Patent Application Publication No. 2009/0132036 (A1) (hereinafter “the '036 application”). The entire contents of which are incorporated herein by reference.

  As shown in FIGS. 8A-8C, the sizing device 86 includes a handle member 88 that is securely attached to the sizing member 90. The handle member 88 includes a handle 92 that is fluidly connected to the distal mounting portion 94. The handle 92 is for guiding the sizing device 86, and the distal attachment 94 is for connecting the handle to the sizing member 90. 8B to 8C, the sizing member 90 includes a front end portion 98, a rear end portion 100, and a first intermediate portion facing each other and extending between the front end portion and the rear end portion. An annular support member 96 having a portion 102 and a second intermediate portion 104 is included. The annular support member 96 has a flat configuration (FIG. 8B) and may be a 3D or saddle configuration.

  The sizing member 90 includes a brazing portion 108 that defines a longitudinal axis 106 (FIG. 8B) and has an attachment mechanism 110, such as an opening for mating with the distal attachment portion 94 of the handle member 88. As shown in FIG. 8B, the brazing portion 108 extends over the longitudinal axis 106 of the annular support member 96. The sizing member 90 further includes the leaflets of the heart valve (eg, the lower surface of the posterior leaflet 26 (eg, the lower free edge 36)) and the valve tissue (eg, chordae 32 and 32 ′ and / or one or more papillary muscles 38). And 38 '), a sub-annular support member 112 is included. As shown in FIG. 8B, the sub-annular support member 112 extends below the longitudinal axis 106 of the annular support member 96. In one embodiment of the present invention, the sub-annular support member 112 may be dimensioned to extend below the mitral posterior leaflet 26 and engage at least one sub-valve structure.

  In order to determine the dimensions of the mitral valve 12 using the sizing device 86, the mitral valve is reached in a thoracotomy. During this operation, the mitral valve 12 is visualized so that the sizing device 86, particularly the sizing member 90, can be positioned around the upper surface of the mitral valve 12. Using the handle 92 to guide the sizing member 90 to the left atrium 14, the annular support member 96 contacts the mitral valve annulus 18, and the sub-annular support member 112 from behind is at least one subvalve. A sizing device 86 is positioned around the mitral valve 12 so as to contact or engage the structure.

The blood flow through the mitral valve 12 is then monitored to assess the junction between the mitral anterior leaflet 24 and the posterior leaflet 26. Multiple sizing members 90 of different dimensions may be placed on the mitral valve 12 until a substantially normal junction of the mitral valve is observed. “Normal blood flow” can refer to the movement of blood through a mammalian valve or vasculature that travels continually under physiologically normal pressure and at a physiologically normal rate. Once substantially normal blood flow is observed through the mitral valve 12, the size of the sizing member 90 is recorded and a device _10e having a size corresponding to the size of the sizing member is selected for implantation. Note that alternatively or in addition, a saline test may be used to assess blood flow through the mitral valve 12 and appropriate leaflet junction.

After selecting the device 10 _e of suitable size, mounting the device, (FIGS. 8D FIG. 8E) delivery device 114 or holder, such as' 036 those disclosed in filed. As shown in FIGS. 8D-8E, the delivery device 114 or holder extends from the front end 118, the rear end 120, opposite each other and between the front end and the rear end. A ring-shaped support member 116 having a first intermediate portion 122 and a second intermediate portion 124 is included. The delivery device 114 or holder includes an attachment mechanism 126 such as an opening for connection to (or close to) the distal attachment 94 of the sizing device 86. The ring-shaped support member 116 has a C-shaped cross section that defines a channel 128 (FIG. 8E). Channel 128 includes a plurality of extensions 130 for extending around the periphery of the ring-shaped supporting member 116 easily attach the apparatus 10 _e to the delivery device 114 or holder. The delivery device 114 or holder also includes a plurality of suture attachment points 132 through which the suture passes to attach the device _10e to the delivery device or holder. By cutting the suture at different points 132, it can be removed device 10 _e.

In starting the grafting of the device 10 _e, the silicone tube (not shown) through the at least one commissure of the mitral valve 12, chordae 32 and 32 'and / or one that is connected with mitral valve after leaflet 26 Located behind at least one subvalvular structure, such as more than papillary muscles 38 and 38 '. Once device 10 _e is securely attached to delivery device 114, a suture (not shown) is placed on mitral valve annulus 18. Thereafter, the delivery device 114 is positioned around the upper surface of the mitral valve 12. Then, while passing the suture in one or more markers 70 (for example holes, etc.), the delivery device engaged to the mitral valve 12, substantially mitral annulus the annular support member 40 of the device 10 _e Advance towards 18 Subsequently, the tube is manipulated such that the open end of the silicone tube engages at least one distal end of the first sub-annular rear support member 42 ′ and the second sub-annular rear support member 42 ″. To do. Thereafter, the tube is gently pulled from the non-engaged end so that the first lower annulus rear support member 42 ′ and the second lower annulus rear support member 42 ″ pass through the commissure. And then engages at least one subvalve structure from behind. Then, after disengaging the tube, the handle 88 is removed and the suture is tightened so that the device 10 _e is firmly positioned around the mitral valve 12. Once the suture has been tightened, the suture is cut so that the delivery device 114 or holder can be removed from the device 10 _e and removed from the left atrium 14.

If the device 10 _e in a state of being placed firmly in position (FIGS. 9A 9C), 2 levels of ventricular remodeling may occur simultaneously. At levels that do not reach the annulus level, the first sub-annular posterior support member 42 ′ and the second sub-annular posterior support member 42 ″ have one or more sub-valve structures during heart contraction. By moving forward, at least one subvalve structure (eg, the lower free edge 36 of the mitral posterior leaflet 26, the chords 32 and 32 'connected to the posterior leaflet and / or one or more connected to the posterior leaflet) The papillary muscles 38 and 38 'of the mitral valve, thereby reducing movement limitations of the mitral valve leaflet and preventing or reducing blood backflow through the mitral valve 12. In addition, left ventricular remodeling caused by ischemic cardiomyopathy and dilated cardiomyopathy is prevented by pushing (or moving) the posterior left ventricular wall forward (or inward) (ie, reverse remodeling mechanism). Or reduced. At the same time, at the annulus level, not only to achieve ventricular remodeling caused by dilated cardiomyopathy and ischemic cardiomyopathy, but also to prevent or reduce the recurrence frequency of mitral regurgitation over time Push part of the left ventricular wall forward. Further, in the annulus level, device 10 _e of the 3D geometry is therefore mitral valve annulus 18 saddle in is remodeling, annular diameter decreases, leaflets junction is improved. When appropriate implant device 10 _e, it is possible to finish the procedure to be able restore normal blood flow through the mitral valve 12.

  FIGS. 10A-12C illustrate other geometric variations of the apparatus 10 shown in FIGS. 1A-1D. As shown in FIG. 10A, for example, the engaging portion 60 of each of the first lower annulus rear support member 42 ′ and the second lower annulus rear support member 42 ″ is configured as a fork. Also good. In particular, each of the engaging portions 60 is separated from each other by a distance D1 (with respect to the central axis CA) and is offset in the axial direction. A portion 74 may be included. The distance D1 depends on factors such as the anatomical structure of the subject's mitral valve 12 and the dysfunction of the individual valve that the subject is suffering from, such as the first sub-annular back support member 42 'and the second It may be the same or different from the lower annulus rear support member 42 ''. The first engaging portion 72 and the second engaging portion 74 may each have a concave shape with respect to the front end portion 50 of the substantially annular support member 40. Further, each of the first engaging portion 72 and the second engaging portion 74 may extend across or behind the whole or a part of at least one subvalve structure (FIG. 10B).

  As shown in FIGS. 11A-11B, the first sub-annular rear support member 42 ′ and the second sub-annular rear support member 42 ″ each have an arcuate and loop-like shape with an opening 134 extending therethrough. It may have a configuration. The engaging portion 60 of each of the first lower annulus rear support member 42 ′ and the second lower annulus rear support member 42 ″ is concave with respect to the front end 50 of the substantially annular support member 40. It may have. In addition, the engaging portion 60 of each of the first sub-annular rear support member 42 ′ and the second sub-annular rear support member 42 ″ may traverse all or only part of at least one sub-valve structure or It may extend behind it (FIG. 11B).

  As shown in FIGS. 12A to 12C, the first lower annulus rear support member 42 ′ and the second lower annulus rear support member 42 ″ are respectively the first valve shown in FIGS. 7A to 7B. It can comprise similarly to an under-wheel rear part support member and a 2nd annulus rear part support member. However, as shown in FIG. 12B, the first lower annulus rear support member 42 ′ is shorter than the second distance D ″ corresponding to the second lower annulus rear support member 42 ″. It is dimensioned to extend by a distance D ′. In other words, the first lower annulus rear support member 42 ′ and the second lower annulus support member 42 ″ are axially displaced from the central axis CA (FIG. 12A) so that the first The distance D ′ is shorter than the second distance D ″.

  As can be further seen in FIG. 12A, the length L1 of the first lower annulus support member 42 ′ is dimensioned to overlap the corresponding length L2 of the second lower annulus support member 42 ″. ing. The engaging portion 60 of each of the first lower annulus rear support member 42 ′ and the second lower annulus rear support member 42 ″ is concave with respect to the front end 50 of the substantially annular support member 40. It may have. In addition, the engaging portion 60 of each of the first sub-annular rear support member 42 ′ and the second sub-annular rear support member 42 ″ may traverse all or only part of at least one sub-valve structure or It may extend behind it (FIG. 12C).

Another embodiment of the present invention is shown in FIGS. 13A-13B. The device 10 _f shown in FIGS. 13A to 13B is configured in the same manner as the device 10 _e shown in FIGS. 7A to 7B except for the points described below. In FIGS. 13A to 13B, the same reference numerals are used for the same structures as those shown in FIGS. 7A to 7B, but similar but not identical structures are denoted by the suffix “f”. Device 10 _f may be constituted by any material as described above, similarly to may comprise a layer 68 and / or one or more therapeutic agents of biocompatible material as described above, it is noted.

As shown in FIGS. 13A-13B, the device 10 _f includes a substantially annular support member 40, a first sub-annular front support member 136, and a second sub-annular front support member 138. . The substantially annular support member 40 is generally annular and includes a first intermediate portion 44, a second intermediate portion 46, and a rear end extending between the first intermediate portion and the second intermediate portion. The part 48 may include a front end portion 50 that faces the rear end portion and extends between the first intermediate portion and the second intermediate portion. Alternatively, the substantially annular support member 40 is partially annular and extends between the first intermediate portion 44, the second intermediate portion 46, and the first intermediate portion and the second intermediate portion. The rear end portion 48 may be included.

  The front end 50 (FIGS. 13A-13B) and the rear end 48 are sized to attach to the front 20 and rear 22 of the mitral annulus 18, respectively. For example, the rear end portion 48, the first intermediate portion 44, and the second intermediate portion 46 form a continuous arc so that the rear end portion is concave with respect to the front end portion 50. . Similarly, the front end portion 50, the first intermediate portion 44, and the second intermediate portion 46 form a continuous arc so that the front end portion is convex with respect to the rear end portion 48. . As shown in FIG. 13B, the substantially annular support member 40 also includes a longitudinal axis LA. The substantially annular support member 40 may have a rigid configuration or a semi-rigid configuration.

The first sub-annular support member 136 and the second sub-annular support member 138 may be used to implant the device 10 _f on or around the mitral valve annulus 18. And is sized, shaped and configured to extend across or behind at least one subvalve structure. The first annulus front support member 136 is directly and securely connected to the substantially annular support member 40 at the first position 52, and the second annulus front support member 138 is At a second position 84 different from the first position, it is directly and securely connected to the substantially annular support member. As shown in FIG. 13A, for example, the first lower annulus support member 136 is directly connected to the first intermediate portion 44, and the second lower annulus support member 138 is 2 is directly and securely connected to the middle part 46 of the two.

  As shown in FIG. 13B, the first sub-annular front support member 136 and the second sub-annular front support member 138 are separated from the longitudinal axis LA of the substantially annular support member 40, respectively. Extends down by distances D3 and D4 at angles A1 and A2. The angles A1 and A2 of the first sub-annular front support member 136 and the second sub-annular front support member 138 correspond to the first sub-annular front support member and the second sub-annular front member, respectively. Each of the support members is such as to facilitate optimal leaflet jointing. In one embodiment of the present invention, the angles A1 and A2 of one or both of the first sub-annular front support member 136 and the second sub-annular support member 138 are about 20 ° to about 40. It may be between ° (eg, about 30 °). It will be apparent that the angles Al and A2 may be the same or different. Similarly, the distances D3 and D4 are such that a portion of each of the first annulus anterior support member 136 and the second annulus anterior support member 138 extends below the anterior mitral valve leaflet 24. Thus, the first and second lower annulus front support members can facilitate optimal valve leaflet joining. It will also be apparent that the distances D3 and D4 may be the same or different.

  The first lower annulus support member 136 and the second lower annulus support member 138 are each configured similarly to the lower annulus rear support member 42 shown in FIGS. 1A to 1B and described above. Also good. For example, the first lower annulus support member 136 and the second lower annulus support member 138 (FIG. 13A) each extend from the engagement portion 140 to the first position 52 from the engagement portion. And an integral neck 142. The engagement portions 140 of each of the first sub-annular front support member 136 and the second sub-annular front support member 138 are arcuate (eg, with respect to the front end 50 of the substantially annular support member 40). Or a convex shape.

Device 10 _f may additionally or optionally thereto, it may include other features as well as other features described above such as the device 10 _e shown in FIG. 7B from Figure 7A, will be obvious. For example, the device 10 _f may include one or more of an adjustable mechanism 54, a layer 68 of biocompatible material, at least one marker 70 and / or a therapeutic agent to facilitate attachment of the device to the mitral annulus 18. Combinations may be included.

Another embodiment of the present invention is shown in FIGS. 14A-14C. 10 _g shown in FIG 14A~14C, except that will be described later, and is configured the same as the device 10 _f shown in Figure 13B from the apparatus 10 and 13A shown in Figure 1E from Figure 1A. 14A to 14C, the same reference numerals are used for the same structures as those of FIGS. 1A to 1E and FIGS. 13A to 13B, but the similar but not identical structures are denoted by the suffix “g ". Device 10 _g may be constituted by any material as described above, similarly to may comprise a layer 68 and / or one or more therapeutic agents of biocompatible material as described above, it is noted.

  As shown in FIG. 15, the tricuspid valve 144 is located between the right atrium 146 and the right ventricle 148. The tricuspid valve 144 is composed of three leaflets (described later), annulus 150, support chords (shown as a whole by 152), and papillary muscles (shown as a whole by 154). Since the tricuspid valve 144 itself is slightly inclined from the vertical, the peripheral edge of the valve is the front upper part, the lower part, and the septum, and the name of each valve leaflet is derived from these binding sites. The anterior leaflet 156 is the largest leaflet and is sandwiched between the atrioventricular mouth (not shown) and the arterial cone (not shown). The posterior leaflet 158 is the next largest leaflet, and the name is derived from the relative position and relationship to the right ventricle 148 periphery. The third smallest leaflet is the septal leaflet 160, which is connected to the left and right fiber triangles (not shown), the atrial septum and the ventricular septum. The tricuspid subvalvular tissue consists of an anterior, posterior, septal papillary muscle 154 and its true chordae 152. A pseudo chord (not shown) may connect two papillary muscles 154, connect the papillary muscles to the ventricular wall, or connect points on the ventricular wall. The true tendon 152 usually exits from the third apex of the papillary muscle 154, but may exit the ventricular wall as in the case of the septal apex 160.

Referring to Figure 14C Figures 14A again, device 10 _g includes a support member 40 _g of substantially annular, and at least one subannular front support member 162 connected thereto may comprise. Support member 40 _g of substantially annular, tricuspid annulus 150 may have a 3D shape corresponding to the 3D shape (Figure 15). Substantially support member 40 _g of cyclic defines a longitudinal axis LA (Fig. 14C), the front end portion 50 _g, and the rear side edge portions 48 _g, are opposed to each other, the front end portion a first intermediate portion 44 _g and the second 46 _g extending between the rear end portion, may include a. Front end 50 _g and the rear end portion 48 _g is sized to be mounted, respectively front and the rear of the tricuspid annulus 150 (Figure 15). Although the substantially annular support member 40 _g (FIGS. 14A-14C) is shown as having a C-shaped or partial ring configuration, the substantially annular support member may be a fully annular ring. It will be apparent that other configurations, such as configurations, may be used.

As shown in FIGS. 14A to 14C, the device 10 _g includes a sub-annular front support member 162. However, the device 10 _g may include two or more sub-annular anterior support members 162 (FIGS. 14D to 14E) and / or one or more sub-annular support members (for supporting the septal cusps 160). It will be apparent that FIGS. 17A-17E) and / or the posterior leaflet 158 of the tricuspid valve may be included. The annulus front support member 162 is dimensioned to extend below or behind the front leaflet 156 and across all or only a portion of at least one subvalve structure. The lower annulus front support member 162 shown in FIGS. 14A to 14C includes the entire lower free edge (not shown) of the anterior leaflet 156, only a portion of the lower free edge of the anterior leaflet of the tricuspid valve, and the tricuspid valve. Dimensioned to extend across or behind only the whole or part of the chordae 152 connected to the front leaflet and / or the whole or part of the papillary muscle 154 connected to the front leaflet of the tricuspid valve It may be made.

  The sub-annular anterior support member 162 includes the entire lower free edge (not shown) of the tricuspid valve septum 160, only a portion of the lower free edge of the tricuspid valve. The lower free edge (not shown) of the posterior leaflet 158 of the tricuspid valve, only the whole or part of the chordae 152 connected to the septum, only the whole or part of the papillary muscle 154 connected to the mesocusp of the tricuspid valve ) Whole, only part of the lower free edge of the tricuspid posterior leaflet, all or part of the chordae connected to the posterior leaflet of the tricuspid valve and / or papillary muscle connected to the posterior leaflet of the tricuspid valve It will be apparent that it may be shaped, configured, or dimensioned to extend across or behind other sub-valescent structures, such as in whole or in part.

The lower annulus front support member 162 may have a rigid configuration or a semi-rigid configuration. When the lower annulus front support member 162 has a semi-rigid configuration, for example, the first lower annulus support member may be bendable or adjustable to various positions. Additionally or optionally to, subannular front support member 162 is substantially as selectively to modulate the (above relative to the longitudinal axis LA of the support member 40 _g of cyclic its position ) An adjustment mechanism 54 may be included.

As shown in FIG. 14C, subannular front support member 162 extends down from the longitudinal axis LA of the substantially annular support member 40 _f by an angle A3 and distance D5. The angle A3 of the annulus front support member 162 is such that the first annulus front support member facilitates optimal leaflet jointing. In one embodiment of the present invention, the angle A3 of the lower annulus front support member 162 may be between about 20 ° and about 40 ° (eg, about 30 °). Similarly, the distance D5 is such that a portion of the lower annulus front support member 162 extends below the anterior leaflet 156 of the tricuspid valve to facilitate optimal leaflet jointing.

The lower annulus front support member 162 has an elongated, substantially U-shaped configuration and includes a neck 164 (FIG. 14A) formed integrally with the engagement portion 166. The neck 164 is dimensioned to extend between or approximately between one of the commissures of each of the tricuspid leaflets 156, 158, 160. As shown in FIGS. 14A to 14B, the necks 164 are arranged opposite to each other, and each of the first end 168 and the first end 168 formed integrally with the substantially annular support member _40g and the engaging part 166, respectively. Two ends 170 are included. For example, first end 168 of the neck 164 can be substantially formed in the first intermediate portion 44 _g and the integral of the annular support member 40 _f.

The engagement portion 166 of the subannular front support member 162 has a substantially concave with respect to side edge 48 _g after the support member 40 _g cyclic. The whole or only part of the engaging part 166 is dimensioned so that only the whole or part of the subvalve structure contacts at the time of implantation. The annulus front support member 162 has any one or combination of the configurations shown in FIGS. 4A to 4B, FIGS. 5 to 6, FIGS. 14D to 14E, and FIGS. 17D to 17E. which may be a (of course with the engaging portion 166, a condition that is concave with respect to any of the substantially annular support member 40 _g of the front end portion 50 _g or rear end portion 48 _g It will be self-evident.

Another embodiment of the present invention is shown in FIGS. 16A-16B. This aspect includes a method for treating regurgitation of blood flow through a tricuspid valve 144 with regurgitation. It will be described below, but the method of the present invention using the apparatus 10 _g shown in Figure 14C Figures 14A, for treating regurgitation of blood flow through the tricuspid valve 144 having the disease, as described herein Note that geometric variations may be used in any one or combination.

As described above, the device 10 _g (FIGS. 14A-14C) includes a partially ring-shaped annular support member 40 _g having a 3D configuration sized for attachment to the tricuspid annulus 150. . The device 10 _g includes a substantially annular support member 40 _g first intermediate portion 44 _f and subannular front support member 162 formed integrally with the. Although not shown in FIGS. 14A-14C, all or only a portion of device 10 _f (eg, annular support member 40 _f, etc.) is attached to a layer 68 of biocompatible material, such as a suture ring, at least one It will be apparent that one or a combination of markers 70 and / or therapeutic agents may be covered.

This method can be implemented in substantially the same manner as described above for treating the mitral valve 12 with regurgitation. For example, the dimensions of the tricuspid valve 144 is first obtained to determine the optimum dimensions for device 10 _g. Tricuspid valve 144 can be sized using a valve sizing device such as sizing device 86 described above. After dimensioning the tricuspid valve 144, blood flow through the tricuspid valve can be monitored to assess the junction between the anterior leaflet 156, the posterior leaflet 158, and the septal leaflet 160 (as described above). . Multiple sizing members 90 of different sizes may be placed over the tricuspid valve 144 until a substantially normal fluid flow (eg, blood or saline) through the tricuspid valve is observed. Once substantially normal blood flow through the tricuspid valve 144 is observed, the size of the sizing member 90 is recorded and a device _10g having a size corresponding to the size of the sizing member is selected for implantation. Note that alternatively or in addition, a saline test may be used to assess fluid flow through the tricuspid valve 144 and proper leaflet junction.

After selecting apparatus 10 _g of suitable size, as described above, mounting the device on the delivery device 114 or holder. To initiate the implantation, a silicone tube (not shown) is passed through at least one commissure of the tricuspid valve 144 and the chordae 152 and / or one or more papillary muscles 154 connected to the anterior leaflet 156 of the tricuspid valve. Or the like behind at least one subordinate structure. When the apparatus 10 _g securely attached to the delivery device 114, a suture (not shown) disposed in tricuspid annulus 150. Thereafter, the delivery device 114 is positioned around the top surface of the tricuspid valve 144. Next, the delivery device 114 is engaged with the tricuspid valve 144 while passing the suture through one or more markers 70 (eg, holes, etc.), and the substantially annular support member 40 _g of the device 10 _g is tricuspid. Advance toward the annulus 150.

After doing so, the tube is manipulated so that the open end of the silicone tube engages the distal end of the sub-annular front support member 162. Thereafter, the tube is gently pulled from its non-engaged end so that the annulus front support member 162 moves through commissure and engages at least one subvalve structure. And after releasing the engagement of the tube, removed the handle member 88, tighten the suture so device 10 _g is firmly positioned around the tricuspid 144. Once the suture has been tightened, the suture is cut so that the delivery device 114 or holder can be removed from the device 10 _g and removed from the right atrium 146.

In the state in which the apparatus 10 _g securely in place (FIGS. 16A 16B), 2 levels of ventricular remodeling may occur simultaneously. At a level that does not reach the annulus level, the annulus anterior support member 162 moves at least one sub-valve structure (eg, Supporting the lower free edge of the anterior leaflet 156 of the tricuspid valve, the chordae 152 connected to the front leaflet and / or one or more papillary muscles 154 connected to the front leaflet, thereby restricting the movement of the front leaflet 24 And blood backflow through the tricuspid valve 144 is prevented or reduced. Furthermore, ventricular remodeling caused by ischemic cardiomyopathy and dilated cardiomyopathy is prevented by pushing (or moving) the anterior and posterior walls of the right ventricle 148 forward (or inward) (ie, a reverse remodeling mechanism). Or reduced. Further, in the annulus level, device 10 _g saddle geometry is therefore tricuspid annulus 150 in 3D of the remodeling, annular diameter decreases, leaflets junction is improved. When appropriate implant device 10 _g, it is possible to finish the procedure to be able restore normal blood flow through the tricuspid valve 144.

Another embodiment of the present invention is shown in FIGS. 18A-18C. Device 10 _h as shown in Figure 18C from Figure 18A, except as described below, and is configured the same as the apparatus 10 _g shown in Figure 14C from Figure 14A. 18A to 18C, the same reference numerals are used for the same structures as those of FIGS. 14A to 14C, but similar structures that are similar but not identical are denoted by the suffix “h”. Note that device 10 _h may be composed of any of the materials described above, and may also include a layer 68 of biocompatible material and / or one or more therapeutic agents as described above.

The device 10 _h may include a substantially annular support member 40 _g and at least one arcuate tristructure support member 200 securely connected thereto. Support member 40 _g of substantially annular, tricuspid annulus 150 may have a 3D shape corresponding to the 3D shape (Figure 15). Substantially support member 40 _g of annular (as shown in FIG. 14C) defining a longitudinal axis LA, and the front end portion 50 _g, and the rear side edge portions 48 _g, are arranged opposite to each other, a first intermediate portion 44 _g and the second 46 _g extending between the front end and the rear end portion may include a. Front end 50 _g and the rear end portion 48 _g is sized to be mounted, respectively front and the rear of the tricuspid annulus 150 (Figure 15). Although the substantially annular support member _40g is shown as having a C-shaped or partial ring configuration, the substantially annular support member can be in other configurations, such as a fully annular ring configuration. It may be obvious that it may be.

The arcuate tristructure support member 200 provides for the implantation of the device 10 _h on or around the tricuspid annulus 150, below the anterior leaflet 156, the posterior leaflet 158, the septal leaflet 160, and at least one subvalvular structure. Are sized, shaped and configured to extend across or behind. Support member 200 pointed arch three structures valve is in a first position 202, which is substantially directly firmly connected to the support member 40 _g cyclic. As shown in FIG. 6A, for example, the support member 200 pointed arch three structures valve is directly rigidly connected to the first intermediate portion 44 _g. Although not shown, the arcuate three structural support member 200, it may also be directly firmly connected to the second intermediate portion 46 _g, will be obvious.

The arcuate tristructure support member 200 has a hook-shaped engagement portion 182 _h that is integrally and directly connected to a substantially annular support member 40 _g via a neck portion 164. The engaging portion 182 _h further includes a first engaging portion 184 _h , a second engaging portion 186 _h, and a bent portion extending between the first engaging portion and the second engaging portion. 188 _h . The first engagement portion 184 _h and the second engagement portion 186 _h are each a continuous arcuate (or arcuate) configured to extend across or behind the at least one subvalve structure. It has a configuration. The first engaging portion 184 _h and the second engaging portion 186 _h have a concave shape and a convex shape (respectively) with respect to the front end portion 50 _g of the substantially annular support member 40 _g. May be.

The first engaging portion 184 _h includes a lower surface of the posterior leaflet 158 (such as a lower free edge of the posterior leaflet (not shown)), a chord 152 connected to the posterior leaflet, Two or more papillary muscles 154, combinations thereof, etc. are configured to extend across or behind at least one subvalvular structure. The second engaging portion 186 _h is connected to the lower surface of the front leaflet 156 (the lower free edge (not shown) of the front leaflet), the chord 152 connected to the front leaflet, and the chord 1 of the front leaflet 1 One or more papillary muscles 154, the lower surface of the septal apex 160 (the lower free edge of the septal apex (not shown), etc.), the chordae connected to the septal apex, and the chordae chordae One or more papillary muscles, combinations thereof, etc. are configured to extend across or behind at least one subvalvular structure. In one embodiment of the present invention, the second engagement portion 186 _h extends across or behind the subvalvular structure connected to (or including) the anterior leaflet 156 and the septal leaflet 160. It is configured.

The first engaging portion 184 _h and the second engaging portion 186 _h are in the same plane when viewed in the lateral direction (that is, a surface extending below or parallel to or substantially parallel to the longitudinal axis LA). ) Or may be offset from each other with respect to a central axis CA (not shown in FIGS. 18A to 18C). As described above, the first engagement portion 184 _h and the second engagement portion 186 _h may be positioned so as to contact with the corresponding same valve structure, or with different corresponding valve structures. You may be located so that it may contact. When the first engaging portion 184 _h and the second engaging portion 186 _h are displaced from each other, for example, the first engaging portion is a lower surface of the rear leaflet 158 (for example, a lower free edge of the rear leaflet). The second engagement portion may be configured to extend across or behind the anterior leaflet 156 and the chordae 152 connected to the septal leaflet 160. It may be configured.

  Another configuration of the annulus front and rear support member 180 is shown in FIGS. 6B to 6C. As shown in FIG. 6B, the engaging portion 182 of the annulus lower front and rear support member 180 may have a bifurcated branch configuration including a first engaging member 190 and a second engaging member 192 that are separated from each other. Good. The first engagement member 190 and the second engagement member 192 may be separated from each other by a distance D1 (based on the central axis CA) and shifted in the axial direction. In general, the distance D1 can be varied depending on factors such as the anatomy of the mitral valve and the dysfunctional state of the individual valve affected by the subject. In particular, the distance D1 can be changed to facilitate contact of the first engagement member 190 and the second engagement member 192 with one or more sub-valve structures. As described above, the first engagement member 190 and the second engagement member 192 include the first engagement portion 184 and the second engagement portion 186, respectively.

  As shown in FIG. 6C, the engaging portion 182 of the front and rear annulus support member 180 may have an arcuate and loop configuration in which the opening 134 extends. The loop-shaped engagement portion 182 may include a first engagement member 190 and a second engagement member 192 that are joined at a common arcuate bend 194. The first engagement member 190 and the second engagement member 192 may be separated from each other by a distance D1 (based on the central axis CA) and shifted in the axial direction. In general, the distance D1 can be varied depending on factors such as the anatomy of the mitral valve and the dysfunctional state of the individual valve affected by the subject.

10 _d, it may also include other features as well as other features described above such as the device 10 shown in Figure 1B from Figure 1A, will be obvious. For example, device 10 _d are adjustable mechanism 54, one of the at least one marker 70 and / or therapeutic agents for the layer 68 of biocompatible material, the device easily attached to the mitral valve annulus 18 or Combinations may be included.

  From the above description of the invention, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes and modifications are within the skill of the artisan.

Claims (8)

A device for treating regurgitation of blood flow through a diseased heart valve comprising an annulus, anterior leaflet, posterior leaflet, and subvalvular structure,
A first intermediate part, a second intermediate part, extending between the first intermediate part and the second intermediate part and attached to the rear part of the annulus of the diseased heart valve; A substantially annular support member having at least a rear end dimensioned;
At least one sub-annular support member that is securely connected to the substantially annular support member in a first position and has a free end under the at least one of the rear leaflet and the front leaflet It extends, and extend into or behind the crossing of at least one valve under construction and dimensioned to contact the lower free edge of the leaflet mitral valve, the at least one subannular A support member;
Including the device. The at least one sub-annular support member comprises:
An arcuate engagement portion configured to contact the at least one subvalve structure from behind;
An integral neck extending from the engagement portion to the first position;
The apparatus of claim 1, wherein the engagement portion has a convex shape with respect to the rear end of the substantially annular support member.   The apparatus of claim 1, wherein the at least one sub-annular support member has a bifurcated bifurcation configuration including a first engagement portion and a second engagement portion that are spaced apart from each other.   The apparatus according to claim 3, wherein the first engagement portion and the second engagement portion are axially offset from each other.   The apparatus of claim 3, wherein the first engagement portion and the second engagement portion are radially offset from each other.   The apparatus of claim 1, wherein the at least one sub-annular support member has an elongated, loop-shaped configuration.   The apparatus of claim 1, further comprising a second sub-annular support member that is securely connected to the substantially annular support member in the first position.   The at least one sub-annular support member is an adjustment mechanism for selectively adjusting the position of the at least one sub-annular support member with respect to a longitudinal axis of the substantially annular support member. The apparatus of claim 1, comprising:

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