WO2004014260A2

WO2004014260A2 - Device of a divisible prosthetic mechanical heart valve

Info

Publication number: WO2004014260A2
Application number: PCT/GR2003/000030
Authority: WO
Inventors: Michail Kantartzis
Original assignee: Michail Kantartzis
Priority date: 2002-08-08
Filing date: 2003-07-18
Publication date: 2004-02-19
Also published as: WO2004014260A3; EP1578312A2; GR1004327B

Abstract

Device of a divisible prosthetic mechanical heart valve, consisting of two structural elements: A. An external stationary ring (1) consisting in turn of two subsequent elements (1 i, 1 ii), and B. An internal moving part (2), which are connected with a connecting wire (3). The external part consists of an annular metallic ring with female groove and an opening (1 i), and of a second ring made out of cloth (1 ii). The internal part (2) consists of a metallic ring and of moving semicircular wings, which can be clamped after implantation of the external ring (1). The advantage of this device is that during valve implantation, initially the external ring is placed and then the internal. Also, in case of post operational implication, total valve removal is not needed, but only the internal part can be removed and then its replacement or implantation can follow.

Description

Device of a Divisible Prosthetic Mechanical Heart Naive

The invention relates to a prosthetic heart valve assembly, which is consisting of two parts.

Usually, heart valves (mechanical valves) form an integral part, which has an external ring and a rotating internal part. This last part, in turn, includes a metallic ring and the valve's wings.

Frequently, when the aortic or mitral ring has a small diameter, the replacement of the mechanical valve with another valve of the largest possible diameter is difficult. Besides, when a valve malfunction is encountered, a total valve replacement is required, something that increases the operational risk.

The device is a heart valve, consisting of two structural elements: the external ring (1) and the internal part (2) (with metallic ring and wings, which can be clamped after mounting the external ring).

The design of the two parts allows for independent manipulation. The external ring (1) is stationary, while the internal part (2) is removable.

This means that the external ring (1) is implanted in the patient in an independent way from the internal one. Also, it remains in the patient without any obligation for removal. Besides, the internal part (2), which represents the main valve mechanism, can rotate in relation to the external ring (1), and can be removed and replaced upon requirement. The connection of the two parts is secured with a connecting element, which can be a wire (3).

With the divisible mechanical valve and the ability of implantation of the external ring initially and of the internal ring in the sequel, the clinical procedures are reduced substantially and a more accurate operational control is achieved during implantation, especially in relation to the leaks in the area of the valve and the proper implantation in the aortic or mitral ring. Also, possible problems appearing during valve implantation can be adjusted, as for example excessive tissues obstructing the proper valve function. Besides, the time needed for valve implantation is substantially reduced, because the possibilities for manipulations are much easier. Finally, in case of post operational implications, as for example in the case of paravalvular leak or valve thrombosis, the internal ring can be removed, the problem can be cured and the same or another internal ring can be implanted.

The external part of the mechanical valve (1) refers to an external construction, which serves as a basis mounted in a stationary way on the patient, and additionally as a basis enabling the support of the main valve mechanism. It is the part of the mechanical valve that is first implanted in the patient, in a way independent of the rest elements of the device. It consists of two elements:

The first (1 i), which is shown in Figure 1, is a circular metallic ring, which has on its inner surface a female groove, ready to serve as nest for the connecting wire, thus holding in firm contact the inner and outer parts. It also has an opening permitting the inlet of the wire. The ring and the connecting wire are shown in Figure 2.

The second element of the external part (1 ii), which surrounds the metallic ring, is also a ring, made out of a cloth of certain type. Its presence assures the assembly of the whole structure, enables the inlet of the connecting wire through an opening provided on its external surface, and also permits the suturing of the valve in the area of replacement. The two rings (made out of metal and cloth) of the external part are shown in Figure 3.

The second part of the mechanical valve (2) refers to the internal construction of the device, which is the main valve mechanism. It is implanted in the patient after completion of the implantation of the external part of the mechanical valve. It can be connected to the external part, and may be replaced without obligatory replacement of the external part. It is characterized as moving part. It consists of an annular element, which also has on its external surface a female groove, especially designed to serve as a nest for the wire connecting the two parts (internal - external). Additionally, on its internal surface, the annular element, that is shown in Figure 4, has two special receptors placed the one opposite to the other in the same diameter, which form a structural support for the moving semicircular wings which perform the main valve function, that is the valve opening and closing, according to the pressure value applied.

The device as an integral, including the external and internal parts, as well as the connecting wire, is shown in Figures 5-7.

The replacement of the internal part is achieved by the following way. Assuming that replacement for a specific patient has been decided only for the internal part, the surgeon must apply the following protocol:

The wire connecting permanently the internal and external parts is untied .

The wire is pulled out. The internal part is removed.

Special local cleaning is applied (according to each case) or repairs of possible problems.

The internal part is replaced by a new one.

Keeping the two parts (internal - external) in contact, the connecting wire is inserted through the indicative point on the outer surface of the external ring of the external part.

The wire is pushed to transverse the groove formed between the external and internal parts.

The other end of the wire is hold. The two ends of the wire are secured.

Claims

Device of a divisible prosthetic mechanical heart valve, consisting of two structural elements, implanted separately and not as an integral unit. These elements are: first, an external part (1) which is stationary, and consists of two elements, that is an annular metallic ring, on the outer surface of which there is a female groove, and an opening enabling the inlet of the connecting wire (1 i, 3) and from one more ring, made out of a cloth of specific type (1 ii), and second, an internal part (2) which is moving and consists of an annular element, which has on its outer surface a female groove, specifically designed to receive the wire connecting the two parts (3), and the internal part of which has two specific receptors placed in an opposite way in the same diameter, which form a structural basis supporting the moving semicircular wings which open and close the aorta regarding the applied pressure value.