WO2009060103A1

WO2009060103A1 - Artificial cardiac valve

Info

Publication number: WO2009060103A1
Application number: PCT/ES2008/000167
Authority: WO
Inventors: Manuel Muñoz Saiz
Original assignee: Munoz Saiz Manuel
Priority date: 2007-11-05
Filing date: 2008-03-27
Publication date: 2009-05-14

Abstract

The invention relates to an artifical cardiac valve consisting of a tubular element part, or a line, carrying an oscillating tongue or lug, which is built into the inner wall of the tubular element or line or is attached by the plane or anterior end thereof, said tubular element or line having a longitudinally hydrodynamic profile and placed in such a way that it is inclined in relation to the longitudinal axis of the line, enabling the blood flow to pass through in one direction in such a way that it is compressed by same, and preventing the flow from backflowing by adapting it to the inside of the line. The line or tubular element can have a circular, semi-circular, semi-oval or rectangular-semicircular cross-section, with rounded corners. The lugs can be covered by at least one resistant and hard-wearing elastic layer or membrane. One of said lugs can be reinforced inside or laterally with a mesh or a fabric of natural or synthetic fibres. The lugs can be elastic, flexible, rigid and semi-rigid, and have a semi-oval or rectangular form with a semi-oval end and rounded corners.

Description

ARTIFICIAL CARDIAC VALVE.

FIELD OF THE INVENTION.- In the replacement or complementation of the heart valves and in artificial hearts.

STATE OF THE TECHNIQUE.- Currently, artificial valves are complicated, destroy red blood cells due to the turbulence used, friction of their shafts and the heart must be opened for installation. With the present invention, said drawbacks are eliminated or reduced.

OBJECTIVE OF THE INVENTION

Simultaneously provide a simple, economical, durable and safe valve. Provide a valve with a longitudinally profiled hydrodynamic profile tab. The only one that is single piece, resistant and without turning axes.

Provide a valve that, due to its small dimensions and because it is compressible, allows it to be introduced by catheterization through veins and arteries, applying it and depositing it in external points to the heart and in series with the damaged valves, avoiding the opening of the thorax, diaphragm, membranes of the thorax, pericarp, myocardium, etc. These points do not show movement, which makes them safer and is valid to replace all valves.

Allow, due to its small size, to put several valves in series, increasing safety. Be able to place the valve or valves, with the single thoracic opening, diaphragm, etc. and of the corresponding veins or arteries, without having to open the heart.

To be able to use valves of easy replacement or periodic replacement if so desired.

Being able to place the valves in the veins or arteries of the limbs, in those cases in which there are great limitations for transplants or operations, because although some veins or arteries between the valve placed and the heart would not receive the irrigation correctly, it could be sufficient to improve the limit or exceptional state of the patient.

Provide a tongue with two floating shafts whose ends, arranged with great slack in cavities, allow the tongue to oscillate. This would be the only valve formed by two pieces.

DESCRIPTION OF THE INVENTION.- The artificial heart valve of the invention consists of a portion of tubular element, or conduit, which carries integrated to its inner wall or held by the flat or anterior end, a swinging tongue or tongue, of longitudinally hydrodynamic profile, positioned inclined with respect to the longitudinal axis of the duct, which allows the passage of blood flow in one direction when pressed by it and prevents its recoil by adapting to the inside of the duct.

The conduit or tubular element can be of circular, semicircular, semi-oval or rectangular-semicircular section and all of them with rounded corners.

The tabs may be covered by at least one layer or membrane of elastic material, resistant and durable. Some of them can be reinforced internally or laterally with a mesh or fabric of natural or synthetic fibers. The surface of the tongue and the inside of the duct is smooth. The tabs may have at least one flange on their periphery, preferably two or three, to facilitate sealing.

The tabs, can be flexible, rigid and semi-rigid elastic, have a semi-oval or rectangle shape with a semi-oval end, with their rounded corners, and can be slightly curved transversely, can oscillate around the peripheral, straight or large curvature anterior end by means of internal filaments, strap or flexible steel reinforcement band that also serve as support. It can also oscillate around an axis. In the latter case, the tongue can be rigid using more resistant and durable materials. Biocompatible and antithrombotic capacity materials, steel, cobalt and titanium alloys, polyester, acrylics, fluorocarbons (Teflon), some silicones, polyamides, polyurethanes and polyethylenes should be used. Other materials, polymers or metal alloys having similar characteristics can also be used. The rigid tabs can be made of graphite with a layer of pyrolytic carbon coated with stainless steel or titanium. The face of the tongue that contacts the conduit when closed can be made of soft material, very elastic, resistant and durable. Swing double fin valves can be used on a support in the duct shaft. Several tabs can be placed in series that provide more security.

The duct acts as a resistant and insulating valve housing, its inner wall can be resistant and elastic. Due to its simplicity and small dimensions the valves can be placed in the arteries or veins in areas outside the heart, being subject to compression of the same and / or by a widening of the duct and some rings or springs. Sausages or stitches can also be placed at the ends of the arteries or veins. For sewing to the artery or veins the valve will be covered with a soft layer or tissue

The valves can be placed by catheterization, in this case they will be flexible, from the large veins or arteries that circulate through the limbs, tablets can be introduced leaving them to expand in the desired place, when said veins or arteries they are not excessively brittle, they can also be placed, inside the veins or arteries, without having to open the heart only the chest and related membranes, thirdly they can also be placed inside the heart, but this solution is the less appropriate The lateral joints of the tabs with the duct are rounded, in this way blood is never trapped in the junction corners between them.

The inclination of the tongues is approximately twenty to forty degrees with respect to the axis of the conduit and can be attached to the conduit: forming a single piece, by gluing, sewing, rivets, bolts, screws, tongue and groove, etc. A widening of the duct can be used in place of the tongue so that the blood flow is greater and in turn to prevent its displacement. This next to the type of tongue very inclined allows the passage of great amount of blood.

The valve assembly consisting of several elements can be covered with a layer of elastic and / or protective material resulting externally in a single piece element. To be able to introduce the valve by catheterization it is necessary that the conduit and even the tongue be elastic, compressible and expandable. The catheter transports the compressed valve by three or four of its generatrices to the corresponding place.

Another variant can use the tongue in a semi-oval or rectangle shape with a semi-oval end, of longitudinally hydrodynamic profile, which has in the anterior edge or in an eccentric area an axis with two very bulky ends which move very loosely on paths cavities in the duct wall, allowing the opening and closing of the valve to a stop by turning. The tongue should have a density similar to that of the blood in which it will float. The cavities in the duct wall can be internal to it or be located in external bulges, in the latter case the restriction of blood flow is minimal. To avoid friction, either the shaft or the cavities must have a very smooth and resistant surface, chromium-cobalt or similar, the opposite can be made of a soft material covered with dracon or Teflon or similar material.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows a schematic and sectioned view of the oscillating tongue valve of the invention.

Figures 2 through 9, 13 and 15 show schematic and sectioned views of variants of the valve of the invention. All of them are covered with a layer of material not shown in the figure that transforms them externally into single pieces.

Figures 10 and 11 show sectional views of tongue variants. Figure 12 shows a schematic and partially cross-sectional view of the valve of the invention.

Figure 14 shows a schematic and partially sectioned plan view of a variant of the valve of the invention. Figure 16 shows a schematic and sectioned view of a heart incorporating the valves of the invention.

MORE DETAILED DESCRIPTION OF THE INVENTION

The system of the invention, figure 1, shows the valve constituted by the tubular element or conduit (1) in whose integrated inner holder, and held by the front end, the oscillating tongue (2) positioned inclined, of longitudinally hydrodynamic profile, the which allows the passage of blood flow in one direction and avoids it in the opposite direction, the steel filaments or threads (5) are optional and reinforce, support and increase the duration of the tongue and therefore of the valve. The lateral joints of the tongue with the conduit (3 and 4) are rounded. The arrow indicates the direction of blood circulation. Figure 2 shows the valve constituted by the tubular element (1), the oscillating tongue (2) positioned inclined, which carries inside the strap-support (5a) and the rounded sides of the tongue (3 and 4).

Figure 3 shows the valve constituted by the tubular element (1), the oscillating tongue (2) and inclined, placed in the widening (6) that prevents the flow restriction and the displacement of the valve, and the rounded sides of the tab (3 and 4).

Figure 4 shows the valve constituted by the tubular element (1), the oscillating tongue (2) positioned inclined, glued and secured by means of the screw and nut (19). placed in front of the widening of the duct (6) and its rounded sides (3 and 4).

Figure 5 shows the valve constituted by the tubular element (1), the oscillating tongue portion (2a) and inclined, whose end (8) is introduced into the support section (7) and the rounded sides of the tongue (3 and 4).

Figure 6 shows the valve constituted by the tubular element (1), the oscillating and inclined tongue (2), the end of which (10) is inserted or covered by the duct wall, the tongue is covered with the layers (11, 12 and 13) and the rounded sides of the tongue (3 and 4). The widening (6a) and the rings or spring (21) allow to compress and expand by holding inside the veins and arteries.

Figure 7 shows the valve constituted by the tubular element (1), the oscillating and inclined tongue (2), the end of which (10) is inserted or covered by the duct wall, the rounded sides of the tongue (3 and 4 ) and is introduced into the vein or artery (14).

Figure 8 shows the valve constituted by the tubular element (1), the oscillating tabs in series (2) and inclined the rounded sides of the tabs (3 and 4).

Figure 9 shows the valve constituted by the tubular element (1), the oscillating tongue portion (2c) and inclined, which oscillates around the axis (15) with the opposition of the strip or spring (17) and which is connected to the duct along the section or support (16) that carries the rounded sides (3 and 4).

Figure 10 shows the cross section of a tongue (2) in the form of a segment with rounded corners. Figure 11 shows the cross section of an tongue (2) in an arcuate shape.

Figure 12 shows the semicircular section duct (1) and the tongue (2) adapted to the walls of the duct and in closed position, rotates around edge (20).

Figure 13 shows the semicircular section duct (1) and the tongue of semi-oval or rectangle shape with a semi-oval end (2d), of longitudinally hydrodynamic profile, which has an axis with two very bulky ends (22) ) which travel very easily in two cavities (23) in the duct wall allowing the valve to open and close until it stops (24). The axis with the bulky ends could be located anywhere in the eccentric area of the anterior half of the tongue. Figure 14 shows the duct (1) and the oval-rectangular tongue (2) with the clamping end of greater curvature and of a longitudinally hydrodynamic profile. Optionally, the tongue can be rotated around the eccentric shaft (15a).

Figure 15 shows the double tongue valve (2 and 2a), which oscillate on or around the support (25) in the axis of the duct. Figure 16 shows the conduit (1) valves (18 and 18a) placed by catheterization, in an area outside the heart, in this case inside the vena cava. It replaces the operation of the tricuspid valve without the need for a major intervention. It would be valid for rupture of the valves of said valve or in case of stenosis of the same, in the latter case it would have to have widened the valve or started its leaflets.

Claims

1. Artificial cardiac valve of the type that allows the passage of blood in one direction consisting of a portion of tubular element, or conduit, which carries integrated to its inner wall or held by the flat or anterior end, a tongue or oscillating tongue, of longitudinally hydrodynamic profile, positioned inclined with respect to the longitudinal axis of the duct, which allows the passage of blood flow in one direction when pressed by it and prevents its recoil when adapting to the inside of the duct

2. Valve according to claim 1, characterized in that the tongues oscillate around the peripheral, straight or large curvature anterior end by means of filaments, strapping or flexible band of internal reinforcing steel that also serves as support.

3. Valve according to claim 1, characterized in that the tubular element is semi-oiled.

4. Valve according to claim 1, characterized in that the tubular element is of semicircular section.

5. Valve according to claim 1, characterized in that the tubular element is of rectangular-semicircular section.

6. Valve according to claim 1, characterized in that the tongues and / or the valve assembly are coated with at least one membrane or layer of elastic material, resistant and durable, resulting externally in a single piece assembly.

7. Valve according to claim 6, characterized in that at least one membrane is reinforced internally or laterally with a mesh or fabric of natural or synthetic fibers.

8. Valve according to claim 1, characterized in that the tongues are flexible or semi-rigid elastic.

9. Valve according to claim 1, characterized in that the tabs are rigid.

10. Valve according to claim 1, characterized in that the tongues have a semi-oval or semi-oval rectangle shape at one end, with their rounded corners, and are slightly transversely curved.

11. Valve according to claim 1, characterized in that the tongues are rigid and oscillate around the peripheral, straight or large curvature anterior end by means of an axis.

12. Valve according to claim 1, characterized in that the tongues are semi-rigid and oscillate around the peripheral, straight or large curvature anterior end by means of an axis.

13. Valve according to claim 1, characterized in that the valve is constituted of biocompatible materials and antithrombotic capacity, metal alloys, cobalt and titanium alloys, steel, polyester, acrylics, fluorocarbons (Teflon), some silicones, polyamides, polyurethanes and polyethylenes.

14. Valve according to claim 1, characterized in that the face of the tongue that contacts the conduit when closed is made of soft, very elastic, resistant and durable material and has at least one flange on its periphery.

15. Valve according to claim 1, characterized by using several tabs in series.

16. Valve according to claim 1, characterized in that the valves can be compressed by means of a catheter in three or more generating lines of the duct, transporting them and allowing them to expand in the appropriate place of the vein or artery.

17. Valve according to claim 1, characterized in that the lateral joints of the tongues with the conduit are rounded.

18. Valve according to claim 1, characterized in that the tongues are positioned inclined between twenty and forty degrees approximately with respect to the axis of the duct.

19. Valve according to claim 1, characterized by using a widening in the place of the tongue so that the blood flow is greater.

20. Valve according to claim 1, characterized in that the tongue is fixed to the inside of the duct by gluing, sewing, rivets, bolts, screws and / or tongue and groove.

21. Valve according to claim 1, characterized in that the valve is covered with a layer of soft material for sewing to veins and arteries.

22. Valve according to claim 1, characterized in that the valve is covered with a fabric of natural or synthetic fibers for sewing to veins and arteries.

23. Artificial cardiac valve of the type that allows the passage of blood in one direction consisting of a portion of tubular element, which carries inside a double oscillating tongue on a support in the axis of the duct which allow the passage of blood flow in one direction when pressed by it and prevents its recoil by adapting to the inside of the duct.

24. Artificial cardiac valve of the type that allows the passage of blood in a single direction consisting of a portion of tubular element or conduit inside which a semi-oval or rectangle-shaped tongue with a semi-oval end, has an anterior eccentric zone of the tongue an axis with two very bulky ends which move very easily in both cavities in the duct wall, allowing the valve to open and close the valve to a stop, the tongue having a density similar to that of the blood.