Percutaneous aortic valve replacement

[0002] This invention relates to aortic heart valves and, in particular, to a percutaneous aortic heart valve that is placed by a catheter or other means and held in place with a stent system without the need for surgery.

[0003] The aortic valve undergoes a series of changes based upon the initial structure at birth and the normal dynamic daily stresses. The trileaflet aortic valve normally will not become stenotic until the seventh decade of a person's life unless infectious processes are introduced earlier. The incidence of aortic stenosis can reach between two and nine percent of the people in this age range. The average mortality rate at all ages is nine percent a year which also increases as a population ages. Coupled with these facts is the likelihood that as a person ages and becomes symptomatic with aortic stenosis, he is less likely to be an operative candidate due to being physically unable to withstand the stresses of surgery. The mortality of octogenarians has been reported as high as 20% for aortic valve replacement which can preclude a reasonable attempt at the therapy of choice, e.g., surgical replacement of the aortic valve using the traditional method of open heart surgery.

[0004] It is therefore the primary object of the present invention to provide an aortic valve that can be placed nonsurgically.

[0005] Another object of the present invention as aforesaid is to provide an aortic valve which may be anchored in the ascending aorta by a stent system.

[0006] Yet another important object of the present invention is to provide an aortic valve as aforesaid which may be placed percutaneously.

[0007] Still another object of the present invention is to provide an aortic valve as aforesaid which functions without removal of the native aortic valve.

[0008] Another important object of the present invention is to provide an aortic valve as aforesaid which reduces regurgitation of a native aortic valve.

[0009] Yet another important object of the present invention is to provide an aortic valve as aforesaid which increases the effective aortic valve orifice area while minimizing the resultant aortic regurgitation.

[0010] Still another important object of the present invention is to provide an aortic valve as aforesaid which reduces left ventricle energy expenditure from aortic regurgitation.

[0011] Yet another important object of the present invention is to provide an aortic valve as aforesaid which reduces long-term ventricular and aortic sequelae from pressure overload caused by aortic regurgitation.

[0012] Another important object of the present invention is to provide an aortic valve as aforesaid which can be placed nonsurgically so as to minimize the health risk to a patient during the procedure.

[0013] These and other objects and advantages of this invention are achieved by an artificial biomechanical aortic valve integrated with a stent system, which may be placed nonsurgically so as to minimize the risk to the patient during the procedure. The aortic valve is anchored in the ascending aorta with further support supplied in branch vessels or descending aorta as necessary due to the stress forces placed on the artificial valve by the normal hemodynamic pressures in the aorta. The valve is connected to the stent system by serially connected rods. Because of the relatively large surface area of the stent system, this design displaces the forces placed upon the artificial valve across this large surface area. Placing the device nonsurgically eliminates the need for a bypass pump or sternotomy and the associated postoperative risks.

[0014] These and other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein is set forth by way of illustration and example, a now preferred embodiment of this invention.

[0015] FIG. 1 is a diagrammatic sectional view of a catheter containing aortic valve and stents of the present invention in the descending portion of an aorta.

[0016] FIG. 2 is a diagrammatic view of FIG. 1 with the catheter advanced to the ascending portion of the aorta.

[0017] FIG. 3 is a diagrammatic view of FIG. 2 with the aortic valve and stents being deployed into the aorta and the stents being expanded by inflation of a balloon.

[0018] FIG. 4 is a diagrammatic view of FIG. 3 with the stents expended and in place and the catheter removed.

[0019] FIG. 5 is a diagrammatic view of FIG. 4 showing the relationship between the placement of the stent system and valve to the aortic valve and left ventricle.

[0020] FIG. 6 is an umbrella aortic valve in a closed position.

[0021] FIG. 7 is a plan view of the umbrella aortic valve of FIG. 5.

[0022] FIG. 8 is the umbrella aortic valve of FIG. 5 in an open position.

[0023] FIG. 9 is a plan view of the umbrella aortic valve of FIG. 7.

[0024] FIG. 10 is a diagrammatic view of a cone-shaped aortic valve in a closed position.

[0025] FIG. 11 is a plan view of the cone-shaped valve of FIG. 10.

[0026] FIG. 12 is the cone-shaped valve of FIG. 10 in an open position.

[0027] FIG. 13 is a plan view of the cone-shaped valve of FIG. 12.

[0028] FIG. 14 is a diagrammatic view of another cone-shaped aortic valve in a closed position.

[0029] FIG. 15 is a plan view of the cone-shaped valve of FIG. 14.

[0030] FIG. 16 is the cone-shaped aortic valve of FIG. 14 in an open position.

[0031] FIG. 17 is a plan view of the cone-shaped valve of FIG. 16.

[0032] FIG. 18 is a diagrammatic view of a cadaver/porcine incorporated valve and stent system.

[0033] FIG. 19 is a plan view of the cadaver/porcine valve of FIG. 18.

[0034] Turning more particularly to the drawings, FIG. 1 illustrates a sectional diagrammatic view of a cannular catheter 20 in the descending portion 22 of aorta 24. Cannular catheter 20 contains a balloon catheter 26 which is surrounded by a wire mesh tube or stent system 28 connected to artificial valve 30.

[0035] The stent system 28 is made up of a small slotted stainless steel tube or series of interconnected rods which form an expandable cylindrical lattice or scaffolding. The stent system 28 is initially collapsed to a small diameter around an angioplasty balloon 29 so that it and valve 30 may be guided into place using an antegrade approach through the fermoral artery (not shown) to the ascending aorta 32 (FIG. 2).

[0036] Once cannular catheter 20 is located in ascending aorta 32 above native aortic valve 34, the balloon catheter 26 is deployed (FIG. 3) to place the valve/stent combination 36 in the correct anatomical position so that valve 30 is above aortic valve 34 (FIG. 4) and below coronary arteries 38 so that the openings to coronary arteries 38 are unobstructed. When the valve/stent combination 36 is correctly placed, the balloon 29 is inflated to expand the stent scaffolding 28 and force the stent system 28 against the inner walls of ascending aorta 32 to anchor valve 30 in place. After balloon 29 is deflated and balloon catheter 26 is removed, the stent 28 remains locked in place. The stent lattice 28 may extend into descending aorta 32 or branch vessels (not shown) to further support and secure valve 30 in place.

[0037] Once the valve and stent combination 36 is in place, the balloon 29 is deflated and balloon catheter 26 is retracted into cannular catheter 20. Both catheters 26 and 20 are removed from aorta 24 through the fermoral artery (not shown).

[0038] Simultaneously with placement of the valve/stent combination 36, the fermoral vein would be accessed and cannulated to guide a balloon catheter into the left ventricle using a retrograde approach to perform a valvoplasty by inflating the balloon within the aortic valve. The purpose of the valvoplasty is to force the aortic valve open to relieve the pressure gradient between the left ventricle 40 (FIG. 5) and aorta 24. Visualization to place the catheters within the aorta 24 and left ventricle 40 would be accomplished using continuous roentgenogram and ultrasound techniques, such as intracardiac echocardiography (ICE) or fluoroscopy, which are known in the art.

[0039] Use of this valve/stent combination 36 precludes removal of the native aortic valve 34. The focus would instead be upon debulking of the native aortic valve 34. The main purpose is abolition of the resting gradient. The techniques employed would attempt to achieve a large effective aortic valve area regardless of the functioning of the native aortic valve 34 post-procedure because an artificial aortic valve 30 designed to prevent aortic regurgitation would be in place. Aortic valve 30 is designed not to hinder the ejection of blood from the left ventricle, and to minimize the aortic regurgitant volume. The techniques used to debulk the native aortic valve may include positioning of an Er-YSGG percutaneous laser to decalcify the valve and repeat balloon aortic valvuloplasty. If this is not effective then high frequency ultrasound percutaneously applied to the aortic valve may be necessary.

[0040] These techniques have been shown to be highly effective at producing debulking and preventing restenosis and increasing the effective aortic valve orifice area. However, they produce tremendous aortic regurgitation. This would not be a problem for the unattached valve 30 which would work as disclosed below for aortic regurgitation.

[0041] If these techniques do not produce the desired result of increasing the effective aortic valve orifice area then a host of options are still available. For example, two rings may be guided onto both the aortic and ventricular sides of the native aortic valve and pneumatically sealed together. Then expandable and retractable biotomes may be percutaneously placed for controlled dissection of the native aortic valve. The biotomes may be used for primary resection without stabilizing rings, but there would need to be a stabilization mechanism for the native aortic valve. Another such mechanism could employ the use of a micro screw into the native valve, which would act as an anchor to guide a biotome onto the native valve. Then the biotomes would take small snips in a controlled fashion off of the native valve. This would gradually increase the effective orifice area. Because the artificial valve is not anchored or dependent upon the native valve for its function, this technique could be easily reapplied, if the native valve were to restenose, without comprising the artificial valve. A tremendous advantage of this procedure would be its independence from a need for a percutaneous bypass pump.

[0042] Referring to FIGS. 6-9, an inverted generally umbrella-shaped valve 30 is shown. Umbrella valve 30 has a generally pear or bulb-shaped main body 52 and a neck 54 which extends from the body. Extending from neck 54 is connecting rod 56 which secures stent struts 58 to umbrella valve 30. Frame members or ribs 60 extend radially from and are hingedly attached to body 52. Hinges 61 permit ribs 60 to move between a folded position (FIGS. 6-7) where the ribs extend generally parallel to neck 54, and an unfolded position (FIGS. 8-9) where the ribs extend generally radially from an perpendicular to body 52. Hinges 61 prevent ribs 60 from overextending when unfolded. A generally circular canopy 62 is secured to the lower sides of each of the frame members 60 and the lower side 64 of body 52. Canopy 62 may be made of a biocompatible, flexible material such as an elastomeric sheet or a Dacron® reinforced polymer, for example. Frame members 60 may be made of stainless steel or a plastic polymer that is able to withstand the shear stresses during folding of valve 30.

[0043] In FIGS. 6-9 frame members 60 are shown generally straight. However, frame members 60 may be curved inwardly toward neck 54 when valve 30 is in the folded or collapsed position (FIG. 6) and generally tangentially to the inner wall of the aorta and toward the stent system 28 (FIG. 4) when valve 30 is in the unfolded position (FIG. 8). Additionally, canopy 62 may extend beyond the ends of frame members 60 to help reduce or eliminate peri-valvular leaks by sealing the valve against the inner wall of the aorta.

[0044] The end 64 of valve body 52 is generally hemispherical which permits the desired laminar blood flow characteristics of the native aortic valve in the aorta around valve 30. Generally, any rounded shape, such as a rounded cone or hemi-ellipse, will produce satisfactory laminar flow.

[0045] Generally, umbrella-shaped valve 30 is placed in a position above the native aortic valve and below the openings of the coronary arteries 28 (FIG. 4). The structure of valve 30 collapses to a folded (FIG. 6) position wherein the ribs extend along the neck such that the canopy does not traverse the aortic channel. Thus, during systolic contraction of the left ventricle the blood from the left ventricle may be expelled unimpeded into the aorta (FIGS. 6-7) as the valve is folded. During diastolic filling of the left ventricle, the pressure in the aorta becomes greater than the pressure in the left ventricle and the blood attempts to flow from the aorta into the left ventricle or regurgitate. This backflow is caught in the canopy 62 which causes valve structure 30 to unfold (FIGS. 8-9) and prevents aortic regurgitation as the opening between the aorta 24 and the left ventricle is sealed. At this position ribs 60 extend radially and generally perpendicular from body 52.

[0046] Referring to FIGS. 10-13 a second embodiment of an artificial aortic valve is shown which may be placed percutaneously. Conical valve 66 consists of two to 32 interconnected plates or fingers 68 and a generally ring-shaped base 70 and a ring 72 secured to the base 70. The fingers 68 are generally wedge or bowling pin-shaped and are hingedly secured together by ring 72 extending through the base 74 of each finger 68 and interconnected by a biocompatible, durable, flexible generally conically-shaped fabric 75 membrane secured to the inside surfaces 69 of the fingers. The fingers 68 extend generally radially inwardly and away from the base 70. Fingers 68 may be constructed of stainless steel, plastic or other biocompatible material.

[0047] In the closed position (FIGS. 10-11), the tops 76 of the fingers contact each adjacent fingertip 76 to prevent regurgitation. It should be understood that if the number of fingers is increased, contact with the adjacent fingers may be along the entire length of the finger 68. If contact is along the entire side length of each adjacent finger when conical valve 66 is in the closed position, a membrane 75 may not be necessary to prevent regurgitation. To minimize components and to aid in miniaturizing the device for delivery, the number of fingers 68 may be reduced to two to four interconnecting fingers 68.

[0048] During systole valve 66 expands or opens as shown in FIGS. 12-13 to allow blood ejected from the left ventricle to flow through the center of valve 66. Fingers 68 pivot on ring 72 and tips 76 separate to allow blood to flow through the center of valve 66. Membrane 75 prevents fingers from overextending to block coronary arteries 38 (FIG. 4).

[0049] Valve 66 and the combined stent 28 is guided into position as shown in FIGS. 1-4, and placed over the native aortic valve 34. Base 70 is seated against the root of the aortic valve 34 next to the inner wall of the aorta 24 below coronary arteries 38. The rim 78 of base 70 is made of a pliable biocompatible material which seals against the root of the native aortic valve 34 to reduce peri-valvular leaks. Valve 66 is anchored along the root of the aortic valve with connecting rods 80 which are connected to the ascending aortic stents 28 (see FIG. 4). Valve 66 is placed such that rods 80 are positioned between the right and left coronary ostia tangentially along the sinus of valsalva. In this embodiment, there are no intraluminal connecting rods 58 within the ascending aorta as with umbrella valve 30 (see FIG. 4).

[0050] Conical valve 66 centralizes the blood ejection jet from the left ventricle providing improved laminar flow characteristics through the valve 66 and minimizes hematologic sequelae.

[0051] Referring to FIGS. 14-17, a third embodiment of an artificial aortic valve is shown which may be placed percutaneously. Trihedral valve 82 is similar in structure and operation to conical valve 66 (FIGS. 10-13). Arms 84 are hingedly attached to ring 86 of base 88 and extend upwardly and radially inwardly from base 88 to generally form a trihedron or cone. Each rod 84 has a crescent-shaped pad 90 at its free end. A cone-shaped membrane 92 of fibrous polymer is secured to each arm 84 and base 88 (not shown in FIG. 14).

[0052] During diastole, back flow of blood from the aorta to the left ventricle causes valve 82 to close preventing regurgitation (FIGS. 14-15). During systole, blood is ejected from the left ventricle to force valve 82 open and allow blood to flow into the ascending aorta through the center of valve 82. Valve 82 is anchored along the aortic valve root wall with connecting rods (not shown; see connecting rods 80, FIG. 10) which are connected to ascending aortic stents 28 (FIG. 4). Valve 82 is placed so that the connecting rods are positioned between the right and left coronary ostia tangentially along the sinus of valsalva. In this embodiment, as in the conical valve 66, there are no interluminal connecting rods 58 within the ascending aorta as with umbrella valve 30 (see FIG. 4).

[0053] Base 88 of valve 82 is constructed as disclosed above for base 70 of conical valve 62. Arms 84 may be constructed of stainless steel or other structural biocompatible material such as plastic. Crescent-shaped pads 90 may be constructed of stainless steel for durability or of softer biocompatible materials to better seal the valve 82 when in the closed position (FIGS. 14-15), and reduce regurgitation.

[0054] Other valvular designs which may prove valuable to this technique include the usage of biological tissue incorporated valves, such as cadaver/porcine valves, placed within a percutaneously stented system the benefits of favorable flow and hematologic characteristics (see FIGS. 18 and 19). Cadaver/porcine valve 100 is retained in a base ring 102. Ring 102 is made of a pliable biocompatible material which seals against the root of the native aortic valve 34 (see FIG. 4) to reduce peri-valvular leaks. Valve 100 is anchored along the root of the aortic valve with connecting rods 104 which are connected to the ascending aortic stents 28 shown in FIG. 4. Valve 100 is placed such that rods 104 are positioned between the right and left coronary ostia tangentially along the sinus of valsalva.

[0055] The central themes involve increasing the effective aortic valve orifice area while minimizing the resultant aortic regurgitation. Thus, the goals in reducing left ventricular energy expenditure and its resultant long-term sequelae of pressure overload would be met with this system of percutaneously delivered aortic valves.