Directionally convertible cardiac valve treatment member

Abstract

The device (30) for disrupting calcification in a heart valve includes a first heart valve treatment element (12) extending from a first shaft (20) and having a scoring portion (16). A second heart valve treatment element (32) extends from a second shaft (36) and has a reaction member (34). The second heart valve treatment element (32) and the reaction member (34) are coupled to the second shaft (36) by a brace (35) positioned to withstand the force exerted by the scoring portion (16) on the reaction member (34).

Description

Technical Field

[0001] The present invention generally relates to an apparatus and method for crushing calcification of heart valves such as aortic valve leaflets.

Background Art

[0002] The aortic valve is generally tricuspid. Bicuspid aortic valve (BAV) is the most common congenital heart malformation. BAV may occur alone or in combination with other congenital malformations such as coarctation of the aorta (CoA).

[0003] Among isolated BAVs, there are patients who are asymptomatic throughout their lives, but there are also patients who develop severe heart complications such as aortic valve stenosis, aortic insufficiency, and / or endocarditis from childhood.

[0004] There are various types of BAVs, which are distinguished by the presence or number of raphes. Raphes are the junctions of two leaflets and are generally the abnormal connections between the two leaflets. When there are no raphes, the valve is strictly called bicuspid. Most BAVs are composed of one free leaflet and two (or leaflets that could not be separated during embryogenesis) joined leaflets. The morphologies of BAVs include type 1 in which the left and right coronary cusps are fused, type 2 in which the right and non-coronary cusps are fused, and the rare type 3 in which the left and non-coronary cusps are fused.

[0005] When raphes are present, problems arise in dealing with stenotic valves. For example, as shown in FIG. 1, in BAV, calcification may be seen in valve leaflet L or raphe R. These calcifications may impair the function of the valve. Furthermore, the presence of calcification poses problems in the implementation of transcatheter aortic valve replacement (TAVR).

Summary of the Invention

[0006] The present invention aims to provide an additional shock wave device that can be used to disrupt the calcification of the aortic valve leaflets in order to enhance the flexibility and mobility of the aortic valve leaflets, either as a sole treatment, a bridging treatment, or for preparing a "landing zone" for transcatheter valve implantation.

[0007] "Disrupt" means reducing the size or changing the shape or form, and includes, for example but not limited to, crushing, pulverizing, breaking, grinding, chopping, etc.

[0008] According to an embodiment of the present invention, there is provided an apparatus for disrupting the calcification of a heart valve, which comprises a first heart valve treatment member extending from a first shaft and having a scoring portion, and a second heart valve treatment member extending from a second shaft and having a reaction member. The first and second heart valve treatment members are arranged to sandwich a part of the valve tissue between the scoring portion and the reaction member. The first heart valve treatment member is movable relative to the second heart valve treatment member, and the position and orientation of the scoring portion are changeable from being parallel or perpendicular to the commissure of the valve.

Brief Description of the Drawings

[0009] The present invention will be more fully understood by reading the following detailed description in conjunction with the drawings.

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[0010] Referring now to FIG. 2, which shows a heart valve treatment device 10 according to a non-limiting embodiment of the present invention.

[0011] The device 10 comprises first and second heart valve treatment members 12, 14. The first heart valve treatment member 12 can include a scoring portion 16 extending from a frame 18, and this scoring portion can extend from a first shaft 20 that can be delivered through a catheter 22. "Scoring" means reducing the size or changing the shape or form, and includes, for example but not limited to, scoring, excision, fragmentation, pulverization, destruction, grinding, chopping, etc.

[0012] In the illustrated embodiment, the scoring portion 16 is arcuate and extends from the two arms of the frame 18. Thus, the scoring portion 16 and the frame 18 form a closed arcuate structure (e.g., loop-shaped) extending from the first shaft 20.

[0013] The second heart valve treatment member 14 may include a reaction member 24 extending from the second shaft 26. The reaction member 24 may be bent or curved so as to be aligned with the scoring portion 16. Both heart valve treatment members can be made of, but are not limited to, stainless steel alloys, titanium alloys, chromium cobalt alloys, shape memory alloys, and the like. The first and second heart valve treatment members 12, 14 can be delivered through the catheter 22 on the guide wire 28. The portion of the anatomical structure of the heart valve to be treated is sandwiched between the reaction member 24 of the second heart valve treatment member 14 and the scoring portion 16 of the first heart valve treatment member 12. Then, one or both of the first and second heart valve treatment members 12, 14 can be moved to apply force and reaction force to score the calcification or excise that portion of the anatomical structure of the valve.

[0014] In a non-limiting example, the guide wire 28 can pass through a blood vessel such as a peripheral artery using a retrograde approach, enter the ascending aorta through the aortic arch, and then move into the left ventricle through the aortic valve. Next, the delivery catheter 22 is moved on the guide wire 28 to deliver the second heart valve treatment member 14 from the ascending aorta to the aortic root, through the aortic annulus, into the left ventricle, and below the aortic valve. The first heart valve treatment member 12 passes through the ascending aorta via the same guide wire 28, then through the atrioventricular junction, and into the aortic sinus of Valsalva at the aortic root, just above the aortic valve leaflets. As a result, the first heart valve treatment member 12 is above the valve leaflets and the second heart valve treatment member 14 is below the valve leaflets. However, other approaches may be used such that the first heart valve treatment member 12 is below the valve leaflets and the second heart valve treatment member 14 is above the valve leaflets. In other embodiments, as will be described later, they may be on the same side of the valve leaflets.

[0015] Figures 4A and 4B show examples of scoring of calcification of valve leaflets and sutures. The position and orientation of the scoring portion 16 of the first heart valve treatment member 12 may be changed from being parallel to the commissure of the valve leaflet (to create a vertical scoring line like the suture as shown in Figure 4A), may be changed from being perpendicular thereto (to create a horizontal scoring line like the valve leaflets on both sides of the commissure as shown in Figure 4A), or may be in between.

[0016] Next, refer to FIGS. 3A and 3B showing a heart valve treatment device 30 according to another non-limiting embodiment of the present invention. The device 30 is similar to the device 10, and like elements are numbered the same. The device 30 differs from the device 10 in the structure and orientation of the second heart valve treatment member 32 (all other structural features described for the device 10 also apply to the device 30). The second heart valve treatment member 32 may comprise a reaction member 34 extending from a second shaft 36. In the illustrated embodiment, the upper portion 37 of the second shaft 36 is coupled to the lower portion 33 of the second shaft 36 by a link member 31, and the link member 31 is an elongated backbone member. The advantage of this structure is that the guide wire 28 can be visually recognized between the upper and lower portions of the second shaft 36. Alternatively, the link member 31 may be a complete or partially complete cylinder. In any case, the second shaft 36 extends to the illustrated position of the lower portion 33. The second heart valve treatment member 32 and the reaction member 34 may be coupled to the second shaft 36 (e.g., its lower portion) by a brace 35. The brace 35 withstands the force applied by the scoring portion 16 to the reaction member 34. The reaction member 34 and the scoring portion 16 of the first heart valve treatment member 12 are not parallel to the guide wire 28. The brace 35 may be inclined with respect to the reaction member 34.

[0017] Accordingly, even in the device 30, the portion of the anatomical structure of the heart valve that is scored or excised is sandwiched between the first heart valve treatment member 12 and the second heart valve treatment member 32. However, both the first heart valve treatment member 12 and the second heart valve treatment member 32 are delivered to the same side of the anatomical structure of the valve, unlike the device 10 that is delivered to the opposite side of the anatomical structure of the valve. By moving the first heart valve treatment member 12 and the second heart valve treatment member 32 towards each other along the guide wire 28, the scoring portion 16 scores the tissue located between the first heart valve treatment member 12 and the second heart valve treatment member 32. Moving the first heart valve treatment member 12 and the second heart valve treatment member 32 towards each other along the guide wire 28 includes the first heart valve treatment member 12 moving with the second heart valve treatment member 32 stationary, the second heart valve treatment member 32 moving with the first heart valve treatment member 12 stationary, and both the first heart valve treatment member 12 and the second heart valve treatment member 32 moving towards each other.

[0018] Next, reference is made to FIGS. 5A and 5B showing a heart valve treatment device 40 according to yet another non-limiting embodiment of the present invention.

[0019] The device 40 comprises first and second heart valve treatment members 42, 44. The first heart valve treatment member 42 may include one or more positioning arms 46 extending from a shaft 48 that can be delivered through the catheter 22. The second heart valve treatment member 44 may include a blade 49. As shown in FIG. 5B, the blade 49 tears or incises the suture R, at which time the suture is supported or held by the positioning arm 46 that functions as a reaction member against the blade 49.

[0020] Next, refer to FIGS. 6A, 6B, and 6C, which show a heart valve treatment device 50 that is similar to device 40 but has structural modifications. In FIG. 6A, the positioning arm 46 can be connected by a cross member 52 parallel to the blade 49. In FIG. 6B, the relative positions (distal and proximal) of the first and second heart valve treatment members 42, 44 are reversed. In FIG. 6C, the blade 49 is arcuate and can operate without cutting with respect to the first heart valve treatment member 42.

[0021] Next, refer to FIGS. 7A, 7B, and 7C. Any of the devices of the present invention can be used to create different tears or incisions in the anatomical structure of the valve, for example, radially within the suture (FIG. 7A), radially adjacent to the suture (FIG. 7B), or circumferentially near the periphery of the suture (FIG. 7C), etc. Next, referring to FIGS. 8A - 8E, a method of tearing the suture and introducing a replacement valve in a TAVR procedure according to a non - limiting embodiment of the present invention is shown.

[0022] FIG. 8A shows the valve before tearing. In FIG. 8B, a tear or scoring can be seen near the base of the suture (the connection of the two leaflets) and on another valve leaflet. In FIG. 8C, the valve leaflets and the suture can be folded to create space for valve replacement. In FIG. 8D, the TAVR replacement valve is placed in the native valve annulus and pressed against the folded valve leaflets and suture. FIG. 8E shows the state where the calcification scoring of the valve leaflets and suture and the TAVR replacement valve are fixed (similar to a conventional TAVR procedure).

Claims

1. A heart valve treatment device (30), comprising a first heart valve treatment member (12) extending from a first shaft (20) and including a scoring portion (16), and a second heart valve treatment member (32) extending from a second shaft (36) and including a reaction force member (34). The first and second heart valve treatment members (12, 32) are configured to be delivered via a guide wire (28). The second heart valve treatment member (32) and the reaction force member (34) are coupled to the second shaft (36) by a brace (35) arranged to withstand the force applied to the reaction force member (34) by the scoring portion (16). A heart valve treatment device (30), characterized in that an upper portion (37) of the second shaft (36) is connected to a lower portion (33) of the second shaft (36) by a link member (31), and the guide wire (28) is configured to be visible between the upper portion (37) and the lower portion (33) of the second shaft (36).

2. The heart valve treatment device (30) according to claim 1, wherein the brace (35) is inclined with respect to the reaction force member (34).

3. The heart valve treatment device (30) according to claim 1, wherein the link member (31) has an elongated backbone member.

4. The heart valve treatment device (30) according to claim 1, wherein the scoring portion (16) is arc-shaped.

5. The heart valve treatment device (30) according to claim 1, wherein the scoring portion (16) extends from an arm of a frame (18) extending from the first shaft (20).

6. The heart valve treatment device (30) according to claim 5, wherein the scoring portion (16) and the frame (18) form a closed arc-shaped structure.

7. The reaction force member (34) is bent or can be bent so as to be aligned with the scoring portion (16), the heart valve treatment device (30) according to claim 1.

8. The first and second heart valve treatment members (12, 32) are disposed on the guide wire (28), the heart valve treatment device (30) according to claim 1.

9. The reaction force member (34) and the scoring portion (16) are not parallel to the guide wire (28), the heart valve treatment device (30) according to claim 6.

10. One of the first and second heart valve treatment members includes a blade, the heart valve treatment device (30) according to claim 1.

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