WO2007009609A1

WO2007009609A1 - Prosthetic ring for heart surgery

Info

Publication number: WO2007009609A1
Application number: PCT/EP2006/006605
Authority: WO
Inventors: José Manuel BERNAL MARCO
Original assignee: Individual
Current assignee: Individual
Priority date: 2005-07-15
Filing date: 2006-07-06
Publication date: 2007-01-25
Anticipated expiration: 2008-01-15
Also published as: ES2286925A1; ES2286925B1

Abstract

A prosthetic ring for heart surgery particularly for the reconstruction of the mitral valve and the tricuspid valve, made up of a prosthetic ring (1) of a flexible material, a closed and pre-formed contour, that when implanted carries out the anuloplasty or reduction of the dilated natural ring (2) to its normal size, and having a net or mesh (3) on its inside that is extended throughout the area defined by the perimeter of the prosthetic ring (1) and prevents the prolapse of one or several vela towards the auricular cavity, allowing the passage of blood from the auricle to the ventricle.

Description

Prosthetic ring for heart surgery

DESCRIPTION

OBJECT OF THE INVENTION

The object of the present Invention is a prosthetic ring for heart surgery that includes significant innovations and advantages compared to other rings used for the same purpose .

More specifically the prosthetic ring of the invention simultaneously repairs two of the main causes of physio- pathological cardio valvular insufficiency of: the dilation of the natural ring and the prolapse of the valvular vela.

BACKGROUND TO THE INVENTION

The heart is made up of four cavities that are connected to each other via some cardiac valves whose job is to allow the passage of blood in a single direction, not allowing the passage of blood in the opposite direction.

The malfunction of the stated valves brings about the incomplete closure of same allowing a return of blood in the opposite direction to that which is physiological. The most frequent illnesses of the cardiac valves are aortic stenosis and mitral insufficiency. Aortic stenosis must presently be treated surgically by means of the use of a replacement with a valvular prosthesis.

The most frequent causes of mitral insufficiency are: degenerative illness or Barlow's Syndrome, it causes secondary ischemia to cardiopathic ischemia from lesions of the coronary arteries or through a myocardial infarction, rheumatic illness, infectious endocarditis, cardiac traumas and congenital disease of the heart. Another cardiac valve, the tricuspid valve, can also suffer from illnesses of differing causes (rheumatic, degenerative, functional, congenital, infectious endocarditis, traumatic) and is also capable of surgical repair.

Both the mitral valve and egually the tricuspid valve can suffer from a disease that brings about malfunction that is characterised by the reflow of blood from the ventricle to the auricle. This lesion is called mitral insufficiency or regurgitation and/or tricuspid, in accordance with the malfunctioning valve.

The blood that flows back pathologically towards the auricle brings about a progressive pathological lesion with fatigue on making an effort or even whilst at rest that is called cardiac insufficiency. On many occasions it requires a surgical operation of open heart surgery to solve the :::cle^~. Of the differing therapeutic surgical options that exist the repair of the diseased valve is, without any doubt, the best option for the sick patient, with the least risk of death both immediate and equally in the long term, a lesser risk of cardiac complications and a better quality of life after the operation.

The valvular insufficiency or regurgitation can be produced by multiple mechanism or lesions that overall causes the valve no to work properly and a part of the blood that the ventricle pumps returns to the auricle. This is because the valve does not completely close to a greater or lesser degree. This incomplete closure can be produced by differing mechanisms but the two most frequent mechanisms and that bring about the highest percentage regurgitation are:

1. The dilation of the natural ring where the vela of the mitral valve (two vela) are anchored or the tricuspid valve (three vela) . When the ring dilates, the vela are separated and produce a lack of coaptation in the half way line where the blood flows back in an anomalous manner.

2. The prolapse of the vela. In addition to the frequent dilation of the ring in the cardio- valvular insufficiencies, the disease itself affects the rest of the valve (vela, tendinous cords, papillary muscles, commisurae) and with great frequency causes a prolapse of one or several vela towards the corresponding auricle.

The vela are not held on the closure plane but because of an excess of movement protrude or prolapse or are anomalously directed towards the auricle. The space that remains between the valvular closure plane and the prolapse of the vela allows the anomalous passage (reflow) of blood towards the auricle bringing about valvular insufficiency and illness.

The surgical repair of the regurgitation lesions or valvular insufficiency, both mitral and equally tricuspid, are carried out using a prosthetic ring. There are a multitude of prosthetic rings of differing forms (without shape, pre-shaped) , of differing flexibilities (flexible, semi-rigid, rigid) and of differing contours (closed, open) .

The prosthetic rings aimed at the reconstruction of the mitral ring generally have a ^ΛD' shaped form, whilst the rings aimed at tricuspid reconstructions have a more or less ovoid form.

All of them try to reduce the size of the natural ring of the valve, which is dilated, until reaching the size that should be that which is normal. In this way, the dilation of the ring is surgically reduced and the separation of the vela, which go back together and to make contact, correcting the regurgitation lesion.

The use of these rings was started in 1968, hence we have more than 30 years experience. This surgical technigue of mitral and tricuspid valve repair is not always effective on its own and is completely insufficient and inadequate on its own if there is a prolapse of one or several of the valvular vela.

In these circumstances, which are very frequent, the prosthetic ring on its own does not solve the problem and surgeons need to carry out other repair techniques to the vela, the cords, the papillary muscles or the ventricle itself.

There are many techniques described to collaborate in the solving of the prolapse of the vela but none of them constitute the ^Λgold standard' and on numerous occasions the valvular repair fails because of the incapacity to correct the prolapse of the valvular vela and the consequent production of the leak. If the repair fails, the only option consists of replacing the valve with an artificial prosthesis.

Taking into account that the repair of the cardiac valves is a complex and very demanding procedure for the surgeon and requires a high degree of operating time the failure of the repair carries with it an increased risk for the patient.

Without doubt, the key to the successful repair of the heart valves consists of a system that allows a surgical correction of the two causes involved in the valvular insufficiency or regurgitation, the dilation of the ring and the prolapse of one or several of the vela.

DESCRIPTION OF THE INVENTION

The prosthetic ring for heart surgery of this present registration solves the previously stated disadvantages, moreover, providing other advantages that will become clear from the description which is attached below.

In order to do this and to be more specific, the prosthetic ring for heart surgery of the invention is particularly for the reconstruction of the mitral valve and the tricuspid valve, it is made up of a prosthetic ring of a flexible material, a closed and pre-formed contour, that when implanted carries out the anuloplasty or reduction of the dilated natural ring to its normal size, and is characterised because on the inside said ring has a net or mesh that is extended throughout the area defined by the perimeter of the ring and prevents the prolapse of one or several vela towards the auricular cavity, allowing the passage of blood from the auricle to the ventricle. The stated net or mesh is interwoven in such a way that it holds itself in an immovable position during the cardiac cycle. Likewise, the tension of the net or mesh is small allowing the absorption of the inertial impact of the vela of the heart valve. Likewise, the net or mesh can be made with materials such as expanded polytetrafluorethylene or prolone®.

In accordance with another aspect of the invention, the prosthetic ring is a tubular structure of a textile nature that encloses a flexible tube that forces the ring to take a predetermined shape, which in general is ^XD' or kidney shaped, the shape that the cardiac valves have when they are closed.

The external tube is made out of a fabric material that allows the prosthetic ring to be connected to the natural ring by means of sutures, the passage of the needles with thread, which is connected to the diseased cardiac ring.

On the other hand, the prosthetic ring that has been developed can be fitted with a support that allows easy handling of same during the surgical procedure. Once the prosthetic ring is implanted in the diseased heart the said support can be released on cutting the sutures, linking device, that connect it to the support. In accordance with the particulars described, the prosthetic ring of the invention surgically corrects the main causes of insufficiency or regurgitation of the heart valves, especially the mitral valve and the tricuspid valve, completely correcting the pathological motives that cause the valvular insufficiency, the dilation of the valvular ring and the prolapse of the vela.

Likewise, it not only attempts to immediately correct the valvular deficiency by dilation of the ring and the prolapse of the vela, but prevents the repaired diseased valve from continuing its natural evolution in the future and reproducing valvular insufficiency because of the diseased vela or the sub-valvular devices that cause the prolapse of same. In order to complete the description that will be made below and for the purpose of providing a better understanding of its characteristics, a set of drawings is attached to this present description in which the figures being by way of illustration and are not by way of limitation on the invention, in which the most significant details of the invention are shown:

BRIEF DESCRIPTION QF THE DRAWINGS

Figure 1 shows a schematic view of the prosthetic ring of the invention; and Figure 2 shows a schematic view of the application of the above prosthetic ring;

DESCRIPTION OF A PREFERRED EMBODIMENT

In view of the figures commented on, and in accordance with the numbering adopted, a preferred embodiment of the invention can be seen in same that is not by way of limitation on the invention, which consists of a prosthetic ring for heart surgery.

As and how can be seen in figures 1 and 2, the prosthetic ring for heart surgery, and particularly for the reconstruction of the mitral valve and the tricuspid valve is made up from a flexible prosthetic ring (1), closed and pre-formed, that once implanted carries out the anuloplasty or reduction of the natural ring (2) dilated to its natural size, and that internally has a net or mesh (3) that is extended throughout the area defined by the perimeter of the prosthetic ring (1) and that prevents the prolapse of one or several vela towards the cavity of the auricle, allowing the passage of blood from the auricle towards the ventricle.

The stated net or mesh (3) is interwoven in such a way that it keeps itself in an immovable position during the cardiac cycle.

The material of the net or mesh can be made with materials such as expanded polytetrafluorethylene or prolone®.

Likewise, the tension of the net or mesh (3) has a predetermined value that allows the absorption of the inertial impact of the vela of the heart valve. In accordance with another aspect of the invention, the prosthetic rung (1) is a tubular structure of a textile nature that encloses a flexible tube that forces the ring to take a predetermined shape, which in general is ^XD' or kidney shaped, the shape that the cardiac valves have when they are closed (not shown) .

The external tube is made out of a fabric material that allows the prosthetic ring to be connected to the natural ring (2) to be made by means of sutures, the passage of the needles with thread (4), which is connected to the diseased cardiac ring.

On the other hand, the prosthetic ring that has been developed can be fitted with a support that allows easy handling of same during the surgical operation. Once the prosthetic ring is implanted in the diseased heart the said support can be released by cutting the sutures, linking device, that connect it to the support (not shown) .

In accordance with the particulars described, the prosthetic ring of the invention surgically corrects the main causes of insufficiency or regurgitation of the heart valves, especially the mitral valve and the tricuspid valve, completely correcting the pathological motives that cause the valvular insufficiency, the dilation of the valvular ring and the prolapse of the vela.

The details, shapes, sizes and other accessorial elements, likewise the materials used for the construction of the prosthetic ring of the invention can suitably be substituted for others that are technically equivalent and do not deviate from the essentials of the invention or the scope defined by the claims which are included below.

Claims

1.- A prosthetic ring for heart surgery particularly for the reconstruction of the mitral valve and the tricuspid valve, it is made up of a prosthetic ring (1) of a flexible material, a closed and pre-formed contour, that when implanted carries out the anuloplasty or reduction of the dilated natural ring (2) to its normal size, and characterised in that on the inside said prosthetic ring

(1) has a net or mesh (3) on the inside that is extended throughout the area defined by the perimeter of the prosthetic ring (1) and prevents the prolapse of one or several vela towards the auricular cavity, allowing the passage of blood from the auricle to the ventricle.

2.- A prosthetic ring for heart surgery, according to the previous claim, characterised in that the net or mesh

(2) material is polytetrafluorethylene.

3.- A prosthetic ring for heart surgery, according to the previous claim, characterised in that the net or mesh (2) material is prolone®.

4.- A prosthetic ring for heart surgery, according to the first claim, characterised in that the tightness of the net or mesh (3) has a predetermined value that allows the absorption of the inertial impact of the vela of the heart valve

5.- A prosthetic ring for heart surgery, according to the first claim, characterised in that the prosthetic ring

(1) has a tubular structure, by preference from a textile material, which has a flexible tube on the inside that gives the prosthetic ring (1) a determined shape.

6.- A prosthetic ring for heart surgery, according to the first claim, characterised in that the prosthetic ring (1) has a configuration that is in general ^ΛD' or kidney shaped.

7.- A prosthetic ring for heart surgery, according to the fifth claim, characterised in that the external tubular structure is connected to the natural ring (2) by sutures.

8.- A prosthetic ring for heart surgery, according to the first claim, characterised in that it is fitted with a removable support that makes its handling easier during the surgical procedure.