WO2007141361A1

WO2007141361A1 - Remotely adjustable prosthetic ring for mitral and tricuspid valve repair

Info

Publication number: WO2007141361A1
Application number: PCT/ES2007/070103
Authority: WO
Inventors: Ignacio RADA MARTÍNEZ
Original assignee: Rada Martinez Ignacio
Priority date: 2006-06-02
Filing date: 2007-05-30
Publication date: 2007-12-13
Also published as: ES2310092A1; ES2310092B1

Abstract

Remotely adjustable prosthetic ring for mitral and tricuspid valve repair, which consists of a ring of biocompatible material composed of three elements: a tubular element of rigid material (1), a further element of semi-rigid material (2) that slides via either of its ends or via both simultaneously inside the first element, and a further element consisting of a device provided with an energy source (4), capable of receiving and translating orders from an external unit with a view to sliding the semi-rigid element of the ring in a controlled manner inside the rigid tubular element, by means of an opening, closure and fastening system, it being possible, once surgery has been completed, to reduce or to increase its perimeter length and therefore its cross-section area.

Description

TELE-ADJUSTABLE PROSTHETIC RING FOR MITRAL AND TRICUSSIDE VALVE REPAIR

OBJECT OF THE INVENTION

The present invention relates to a tele-adjustable prosthetic ring for the repair of the inlet heart valves, that is to say a ring of those that are inserted at the level of the orifices of the heart valves in order to correct the incompetence thereof and in this way try to guarantee the maintenance of a physiological hemodynamic state, avoiding the problems derived from an alteration of the closure of these valves that ultimately leads to heart failure.

The object of the invention is to achieve better functional performance of the ring from the point of view of maintaining valvular competence, allowing its modification from the outside once the surgery is performed, its progressive adjustment being possible, avoiding situations of heart failure postoperative and managing to eliminate to a large extent - if not completely - valvular insufficiency, problems that are often associated with the use of conventional rings of fixed size.

BACKGROUND OF THE INVENTION The insufficiency or defect of closure of the mitral and tricuspid valves is a pathology that presents an increasing frequency in the population, whose evolution implies a deterioration of the function of the heart with the establishment of the heart failure syndrome, thus representing a pathology with long or short term adverse prognosis - depending on the cause that motivates it - and with high prevalence in the population. The surgical treatment of this pathology basically offers two alternatives: the replacement of the valve with a complete prosthesis that mimics the valve function or its repair. This last treatment is preferable given its greater degree of preservation of the valvular apparatus and lower morbidity and mortality associated with the intervention, achieving a more physiological correction of the valvular defect. Today, repair surgery tends to be carried out early in cases of severe valvular insufficiency, without waiting for incipient signs of ventricular involvement with what seems to favor the prognosis of patients. For the performance of valvular repairs, the use of ring-shaped devices, which are implanted by surgery, is frequent Cardiac, consisting of different materials and presenting different shapes and sizes. These rings are generally covered with silicone and elastic material, biocompatible, usually polyester, which allows their insertion, by suture, at the level of the hole or natural ring of the native cardiac, mitral or tricuspid valve, thus achieving a cerclage of the same, since in general the closing defect they present is due to an insufficient coaptation of the valvular veils, frequently produced by dilatation of the native ring.

The insufficiency of the inlet heart valves (mitral and tricuspid) can be described as acute (of rapid establishment) or chronic (of slow and progressive establishment). Most of the cases that undergo repair are due to chronic type insufficiency, that is to say that it has occurred slowly, generally over the course of years, becoming severe. During this slow evolution, the heart finds a path (pathological) of less resistance to eject the blood through the insufficient valve, which, by not closing properly, allows that blood to escape through it with each cardiac contraction. That volume of blood ejected pathologically by the insufficient valve returns to the heart during the next cycle assuming a volumetric overload that gradually dilates the ventricles until it causes them to fail. At the same time, the dilatation of the ventricles causes the natural rings of the valves to dilate and therefore increases the difficulty of closing or coaptation of the valvular veils, thus generating a vicious circle with increasing valvular insufficiency.

The rings intended for valve repairs that currently exist on the market are made of rigid or semi-rigid materials, and have a fixed size. As mentioned, a cardiac surgery procedure with opening of the chest and cardiac chambers is required for insertion. It is of crucial importance the choice of the size of the ring to be inserted, which today can only be made at the time of surgery and depending on certain measures of the patients' anatomy. The fact that there is a wide variety of rings on the market for mitral and tricuspid valve repair indicates in some way the existence of a complex problem, still not well resolved.

After surgery, complications arising from the new hemodynamic situation that may be created with valve repair may occur. This is especially serious in the case of mitral valve, during Immediate postoperative, since the fact of repairing the valve abruptly eliminating the closing defect that served as an escape for a more comfortable ejection of blood means that the ventricle must adapt abruptly to the new situation created, which represents an increase Sudden resistance to emptying, a situation that can cause it to fail, thus significantly limiting the effectiveness of surgical treatment.

Another problem of great importance that can occur after the implantation of the currently existing prosthetic rings is that there is some degree of residual valve insufficiency, that is to say, with the surgery performed, it is possible to pass from a severe grade to a light grade valve insufficiency or moderate. This situation is ominous because the post-surgical residual insufficiency is progressive in nature and tends to increase over time, and may again become severe and require new cardiac surgery for correction. That is why it has been proposed to perform the repair with the choice of small rings through what is known as "restrictive annuloplasty", although this technique does not guarantee the definitive correction of the valvular defect. Therefore, as already mentioned, the size of the ring to be implanted can be a crucial determinant of the result of the intervention and therefore of the patient's prognosis. DESCRIPTION OF THE INVENTION

The tele-adjustable ring for valve repair that the invention proposes could satisfactorily solve a large part of the above-mentioned problem, in each and every one of the aspects mentioned.

For this and more specifically, said ring, based on the basic structuring of conventional rings that currently exist on the market, that is, devices made of rigid or semi-rigid biocompatible materials, of fixed size, adapted to the valve anatomy that the patient presents at the time of surgery, focuses the characteristics on the innovative fact that incorporates a mechanism capable of allowing a modification "a posteriori" and from the outside of the body, the shape and size of the ring, once the valve repair surgery.

The ring proposed by the invention is basically composed of three elements:

• Element 1: made of rigid, cylindrical and hollow biocompatible material (titanium or similar), of tubular structure, whose internal section is divided in two subsections throughout it to allow sliding through each of the mentioned subsections of element 2 described below, thus serving as a guide to that element. • Element 2: of biocompatible material (elgiloy, nitinol or similar) semi-rigid, with each of its ends inserted in each of the subsections of element 1, delimiting along with it, the area of the ring, and thus mimicking the native valvular anatomy . The ends of this element that are inserted into the element 1, reach the central portion thereof, where the element 3 mentioned below is located.

• Element 3: constituted by a device that incorporates a source of energy capable of translating orders received from an external unit in the sense of progressively and in a controlled way sliding the ends of element 2 into element 1 in order to close the valve hole, in such a way that each end can slide independently within its corresponding subsection of element 1, or both together, controlling at all times the magnitude of the order sent through an opening, closing and fixing system. The reverse order could also be executed, removing or sliding out the ends of the 2 element if necessary to increase the area of the ring and therefore the valve hole.

Element 1, in the case of mitral valve repair, must be inserted into the intertrigonal zone, which constitutes the stiffer portion - less deformable - of the fibrous skeleton of the native valve ring. Element 2 must cover the rest of the annular perimeter.

The entire prosthetic ring proposed by the invention, similar to the current rings in use, incorporates a silicone coating and a biocompatible elastic material, such as polyester, which allows insertion by suture to the native valve ring, constituted from the point anatomically, by the fibrous skeleton of the heart.

Given the exposed characteristics of the ring object of the invention, the following advantages can be expected with respect to the rings currently available on the market: 1. The ring model presented as an invention, being able to be regulated from the outside once the surgery is performed, it allows to adjust properly and controlled, gradually reducing its perimeter and therefore the area of the valvular orifice, by introducing the semi-rigid element in the rigid, achieving adequate coaptation of the veils Valves and thus correcting valvular insufficiency in a progressive manner, similar to how it originated, allowing an adaptation of the heart (ventricles) also progressive and physiological to the repair of the valvular closure defect.

2. It eliminates the need to perform what is known as "restrictive annuloplasty" which involves implanting small rings for fear of leaving residual valvular insufficiency that can evolve to more severe degrees.

The use of non-invasive diagnostic techniques such as Doppler echocardiography will help to progressively adjust the ring object of the present invention until correcting valvular insufficiency and achieving a hemodynamic state as physiological as possible. 3. The possibility of reducing the section delimited by the ring by acting independently for each of the ends of the semi-rigid element, element 2, would allow to correct more physiologically certain types of valve insufficiency in which the valve failure is found more circumscribed to a portion thereof. This aspect is especially interesting when it comes to the mitral valve, where day-to-day progress is made in the anatomical diagnosis of valvular dysfunction through Doppler echocardiography, trying to discern which portion of the valve is responsible for the insufficiency or incompetence of the same to act more specifically on it and thus provide a more appropriate and effective treatment.

4. This ring model could be valid to treat different types of valvular insufficiency and can be implanted in all degrees of dilation of the native ring without having to choose rings of different sizes and morphologies depending on the cause of the valvular defect. DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention and its operation, in accordance with an example of practical realization thereof, two integral sheets are attached as an integral part of said description. planes in which with an illustrative and non-limiting nature, they have been represented schematic, plan, sections and perspective (Figures 1, 2, 3 and 4) of the tele-adjustable prosthetic ring for mitral and tricuspid valve repair performed in accordance with the object of the present invention, as well as the external unit (Figure 5) for remote regulation. A more detailed explanation of the invention is given in the following description based on the attached figures in which: Figure 1 shows in a plan view of the prosthetic ring according to the invention, Figure 2 shows in a sectional view of the prosthetic ring according to the invention, figure 3 shows in an elevation view the prosthetic ring according to the invention, figure 4 shows in a perspective view of the prosthetic ring according to the invention and, figure 5 shows a perspective view of a remote control according to the invention.

PREFERRED EMBODIMENT OF THE INVENTION

In view of the figures described, which represent a ring for insertion in the mitral valve, it can be seen how the ring object of the invention is constituted by a rigid non-deformable element 1 in which each of the two ends of the element are inserted. semi-rigid 2 to which it serves as a guide, both elements being composed of biocompatible material, similar to that used in current rings for use, both elements forming a morphology that mimics the native valvular anatomy. A device is incorporated in the central part of the rigid element 1

4 which is provided with a power source 3 and an opening, closing 5-1 and fixing 5-2 system with what is achieved, upon receiving the appropriate order issued from an external unit 5, namely, remote control, that the ends of the semi-rigid element 2 move, in the magnitude deemed necessary, within the rigid tubular element 1 that serves as a guide, both ends being superimposed within this element and thus reducing the perimeter and area of the ring, in order to obtain a better coaptation of the valvular veils and the elimination of valvular insufficiency. It is also possible, if necessary, to slide out the ends of the semi-rigid element 2 in order to increase the perimeter of the ring and therefore the area thereof.

According to Figure 3, the element 1 is formed from a rigid metal structure 1-2, cylindrical and hollow of titanium or the like, externally coated with biocompatible materials such as polyester 1-1, silicone 1-2 or the like.

The tubular structure, whose inner section is divided into two subsections 3-1, 3-2 along its entire length to allow sliding through each of the mentioned subsections of element 2 described below, thus serving of guidance to that element 2.

Element 2 is formed from a rigid metal structure 2-1, cylindrical coated externally with biocompatible materials such as polyester 2-3, silicone 2-2 or the like. The materials used in the manufacture of the components of the ring presented will be independent of the object of the invention, as well as all the accessory details that may arise, as long as they do not affect their essentiality.

Claims

R E IV I N D I C A C I O N E S

I ^a . Teleajustable prosthetic ring suitable for mitral and tricuspid valve repair, equipped with a device with a mechanism that allows its regulation from the outside with remote control (5), once the surgery has been performed, to reduce or increase its perimeter length and therefore Your section area.

2 ^a . Teleajustable prosthetic ring suitable for mitral and tricuspid valve repair according to claim 1, consisting of three elements: a tubular element of rigid material (1), another element of semi-rigid material (2) that is introduced by each of its ends in the element (1) mentioned above, forming the morphology and section of the ring and another element consisting of a device (4) provided with a power source (3), capable of receiving and translating orders from the external unit (5) in the sense to slide in a controlled way the semi-rigid element (2) of the ring into the rigid tubular element, by means of an opening, closing and fixing system.

3 ^a . Teleajustable prosthetic ring suitable for mitral and tricuspid valve repair according to claims 1 and 2, characterized in that it allows the modification of both the morphology and the section thereof by allowing simultaneous or independent sliding of both ends of the semi-rigid element ( 2) inside the rigid element (1).