US-12622782-B2 - Prosthetic device for implantation in the aortic valve region of a heart

US12622782B2US 12622782 B2US12622782 B2US 12622782B2US-12622782-B2

Abstract

The present invention relates to a prosthetic device for deployment in the native aortic valve region of a heart, comprising a tubular spacer element, the spacer element being configured for placement within the native aortic valve region of a heart without contacting to the native aortic annulus; the prosthetic device further comprises at least one anchoring element designed for anchoring the prosthetic device within the heart, and at least one connecting element, coupling the spacer element to the at least one anchoring element; in the prosthetic device, the tubular spacer element further comprises a coaptation skirt element being connected to the outer surface of the spacer element, such, that the coaptation skirt element is inflatable during diastole.

Inventors

Maximilian KUETTING
Steffen Westermann

Assignees

NVT AG

Dates

Publication Date: 20260512
Application Date: 20221027
Priority Date: 20200429

Claims (12)

1 . A prosthetic device for deployment in the native aortic valve region of a heart, the native aortic valve region comprising the native aortic valve having a native annulus and native valve leaflets, the prosthetic device comprising: a tubular spacer element comprising an outer surface, an inner surface, a length, a proximal inflow end, a distal outflow end and a lumen defined there between, the spacer element being configured for placement within the native aortic valve region of a heart without contacting to the native aortic annulus, and comprising a valve element being attached within the lumen to the spacer element's inner surface at the proximal inflow end; at least one anchoring element, wherein the anchoring element is spatially separate from the tubular spacer element, and wherein the anchoring element is designed for and capable to anchor the prosthetic device within the native aortic valve region of a heart; and at least one connecting element, coupling the spacer element to the at least one anchoring element, such, that spacer element is co-axially aligned and suspended inside the native aortic valve without contact to the aortic annulus, wherein the tubular spacer element comprises a coaptation skirt element, having a distal end and proximal end, the coaptation skirt element being attached, solely via its distal outflow end and its proximal inflow end, to the outer surface of the spacer element, such, that the portion between the proximal and distal end of the coaptation skirt element is not fixedly attached to the outer surface of the tubular spacer element, and that the coaptation skirt element is inflatable during diastole, such, that the coaptation skirt element, with the portion not fixedly attached to the outer surface of the spacer element is detached from the outer surface during diastole in a ballon-like fashion.
2 . The prosthetic device of claim 1 , wherein the coaptation skirt element, starting from the proximal inflow end of the spacer element, circumferentially covers the spacer element's outer surface up to 30%, 40%, 50%, 60%, 70%, 80%, 90%, or up to 100%.
3 . The prosthetic device of claim 1 , wherein the coaptation skirt element comprises or consists of a material selected from the group of biocompatible artificial material or biocompatible natural material, and in particular is selected from human or animal pericardium, polytetrafluoroethylene (PTFE), polyurethane and polyester.
4 . The prosthetic device of claim 1 , wherein the tubular spacer element comprises or consists of a tubular stent frame, and has a cross section that is selected from substantially round, oval, and triangular.
5 . The prosthetic device of claim 1 , wherein the anchoring element consists of a cylindrical stent element.
6 . The prosthetic device of claim 1 , wherein the anchoring element consists of a cylindrical stent element, and that the at least one connecting element consists of one or more singular non-tubular, straight flexible connecting element, the connecting element comprising a first end, a second end and a length extending there between, wherein the connecting element, via its respective first end is coupled to the spacer element, and, via its respective second end, is coupled to the anchoring element, wherein the length of the connecting elements is such, that when the anchoring element is placed downstream of the coronary arteries, the spacer element is suspended within the native aortic valve region of the heart without contacting to the native aortic annulus.
7 . The prosthetic device of claim 1 , wherein the anchoring element consists of a cylindrical stent element, and that the at least one connecting element consists of one or more singular non-tubular, curved flexible connecting element, the connecting element comprising a first end, a second end and a length extending there between, wherein the connecting element via its respective first end is coupled to the spacer element, and, via its respective second end, is coupled to the anchoring element, wherein the length and shape of the connecting elements is such, that when the anchoring element is placed in the aortic root, the spacer element is suspended within the native aortic valve region of the heart without contacting to the native aortic annulus.
8 . The prosthetic device of claim 1 , wherein the at least one connecting elements consist of one or more U-shaped lengthy attachment arm elements, the attachment arm elements comprising a first end, a second end and a length extending there between, wherein the attachment arm elements, via its respective first end is coupled to the spacer element, and, at its respective second end, comprises the at least one anchoring element, wherein the anchoring element consists of attachment means for anchoring the device in tissue surrounding the native aortic annulus, the attachment means being selected from one or more of a hook, a spike or an arrow.
9 . The prosthetic device of claim 1 , comprising a combination of one or more of the following anchoring elements (i) to (iii): (i) an anchoring element consisting of a cylindrical stent element; (ii) an anchoring element consisting of a cylindrical stent element, and the at least one connecting element consisting of one or more singular non-tubular, straight flexible connecting element, the connecting element comprising a first end, a second end and a length extending there between, wherein the connecting element, via its respective first end is coupled to the spacer element, and, via its respective second end, is coupled to the anchoring element, wherein the length of the connecting elements is such, that when the anchoring element is placed downstream of the coronary arteries, the spacer element is suspended within the native aortic valve region of the heart without contacting to the native aortic annulus; (iii) an anchoring element consisting of a cylindrical stent element, and the at least one connecting element consisting of one or more singular non-tubular, curved flexible connecting element, the connecting element comprising a first end, a second end and a length extending there between, wherein the connecting element via its respective first end is coupled to the spacer element, and, via its respective second end, is coupled to the anchoring element, wherein the length and shape of the connecting elements is such, that when the anchoring element is placed in the aortic root, the spacer element is suspended within the native aortic valve region of the heart without contacting to the native aortic annulus.
10 . A method for treating aortic valve regurgitation, the method comprising the steps of providing the prosthetic device of claim 1 , and deploying the prosthetic device in the aortic valve region of a heart in a patient in need thereof in order to replace in its function or support the native aortic valve of said patient.
11 . A method for treating aortic valve regurgitation the method comprising the following steps: providing the prosthetic device of claim 1 , the device comprising a stent element as anchoring element, introducing the prosthetic device in the aortic valve region of a heart of a patient in need of treatment, deploying the anchoring element downstream of the coronary arteries, preferably in the ascending aorta, thereby suspending the spacer element inside the native aortic annulus.
12 . A method for treating aortic valve regurgitation the method comprising the following steps: providing the prosthetic device of claim 1 , the prosthetic device comprising a stent element as anchoring element, introducing the prosthetic device in the aortic valve region of a heart of a patient in need of treatment, deploying the anchoring element in the aortic root behind native aortic leaflets, i.e. upstream of the coronary arteries, thereby suspending the spacer element inside the native aortic annulus.

Description

CROSS REFERENCES TO RELATED APPLICATIONS This application is a continuation of International Patent Application No. PCT/EP2021/060330, filed on Apr. 21, 2021, which claims priority to German patent application DE102020111681.0, filed on Apr. 29, 2020. The entire contents of each of these priority applications is incorporated herein by reference. BACKGROUND The present invention concerns an implantable prosthetic device for implantation in the native aortic valve region of a heart, in particular for treating aortic valve regurgitation, as well as the use of such a device for treating diseased or otherwise dysfunctional aortic valves. Nowadays, prosthetic aortic valve devices are used as a possible treatment of aortic valve insufficiency, also referred to as aortic regurgitation. Such prosthetic valves are delivered by traditional surgical implantation methods, or by less invasive percutaneous catheter or minimally invasive methods. The mammalian heart comprises four chambers, i.e. two atria, which are the filling chambers, and two ventricles, which are the pumping chambers. In a mammalian heart, there are four heart valves present which normally allow blood to flow in only one direction through the heart, whereby a heart valve opens or closes depending on the differential blood pressure on each side. The four main valves in the heart are the mitral valve, representing a bicuspid valve, and the tricuspid valve, which are between the upper atria and the lower ventricles, respectively, and thus are called atrioventricular (AV) valves. Further, there are the aortic valve and the pulmonary valve which are in the arteries leaving the heart. The mitral valve and the aortic valve are in the left heart and the tricuspid valve and the pulmonary valve are in the right heart. The valves incorporate leaflets or cusps, wherein each valve has three cusps, except for the mitral valve, which only has two. The aortic valve, which normally has three cusps, is situated between the left ventricle and the aorta. The aortic valve is the last structure in the heart the blood travels through before stopping the flow through the systemic circulation. The aortic valve—like to pulmonary valve—is also called “semilunar valve”, permitting blood to be forced into the aorta, and prevents backflow from the aorta into the ventricle during diastole. During ventricular systole, pressure rises in the left ventricle and when it is greater than the pressure in the aorta, the aortic valve opens, allowing blood to exit the left ventricle into the aorta. When ventricular systole ends, pressure in the left ventricle rapidly drops and the pressure in the aorta forces aortic valve to close. Several different kinds of valve disorders are known, such as stenosis, which occurs when a heart valve doesn't fully open due to stiff or fused leaflets preventing them from opening properly, or prolapse, where the valve flaps do not close smoothly or evenly but collapse backwards into the heart chamber they are supposed to be sealing off. Valve regurgitation (backward flow) is also a common problem, and occurs when a heart valve doesn't close tightly, as a consequence of which the valve does not seal and blood leaks backwards across the valve. This condition—also called valvular insufficiency—reduces the heart's pumping efficiency: When the heart contracts blood is pumped forward in the proper direction but is also forced backwards through the damaged valve. As the leak worsens, the heart has to work harder to make up for the leaky valve and less blood may flow to the rest of the body. Depending on which valve is affected, the condition is called tricuspid regurgitation, pulmonary regurgitation, mitral regurgitation, or aortic regurgitation. Aortic regurgitation, i.e. the abnormal leaking of blood from the aorta through the aortic valve and into the left ventricle when the left ventricle contracts, is a common valvular abnormality. A dysfunction of the valve results in left ventricular hypertrophy and heart failure. Common causes of aortic regurgitation include vasodilation of the aorta, previous rheumatic fever, infection such as infective endocarditis, degeneration of the aortic valve, and Marfan's syndrome. Aortic stenosis can also be caused by rheumatic fever and degenerative calcification. The most common congenital abnormality of the heart is the bicuspid aortic valve, i.e. the fusion of two cusps. Surgical intervention is recommended for symptomatic severe aortic regurgitation or asymptomatic severe aortic regurgitation with left ventricular dysfunction or enlargement. Meanwhile, as already mentioned at the outset, aortic valve repair and replacement has also been achieved using minimally invasive procedures. The desire for less invasive approaches is linked with the fact that a significant proportion of patients, especially elderly persons or those with significant comorbidities or severe left ventricular dysfunction, are not referred for (open heart) surg