ES2682544A1 - Artificial venous or cardiac valve (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

The artificial heart or venous valve consists of a one-piece check valve constituted by a cylindrical or cylindrical ovoid tubular element which internally carries an ovo-spherical or ogival obturator element with a hydrodynamic or hemodynamic profile divided into at least two triangular leaves in one end. shape of ovo-spherical helmets or sectors arranged longitudinally, whose outermost end oscillates perpendicular to the axis of symmetry, creating a variable opening nozzle, which opens allowing the passage of blood flow in a sense to be pressed or sucked by the same and it avoids its recoil when the pressure or suction is stopped, the leaves joining and adapting laterally to each other, the ends of the tubular elements are beveled and/or rounded. (Machine-translation by Google Translate, not legally binding)

Description

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DESCRIPTION

Artificial cardiac or venous valve.

Field of the Invention

In the replacement or complementation of cardiac valves, venous valves and those of artificial hearts.

State of the art

It can be considered continuation of the patent P200800426 with which the inconveniences of implantation of the current valves are eliminated or reduced.

Objective of the invention

Provide single-piece, simple, economical valves that do not produce noise (avoiding turbulence and knocking), durable, safe and of great hemodynamics with rubber-based materials, latex, silicones, polymers, etc., in addition to those already used, preferably biocompatible . Not needing high specialization for its manufacture.

Provide some valves, which due to their small dimensions and being compressible, allows them to be introduced by catheterization through veins and arteries, applying them and depositing them at points outside the heart and in series with the cardiac valves or in the place of the deteriorated venous valves , avoiding the opening of the thorax, diaphragm, thorax membranes, pericarp, myocardium, etc., or heart surgery. These application points do not show movement, which makes them safer and is valid to replace all the valves.

Provide valid valves for artificial hearts.

To be able to place the 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 of periodic replacement.

Allow external use to the heart of valves of a smaller diameter and more elongated. Due to their small size, several valves can be placed in series, increasing safety. Also of greater flow if necessary.

Use the valves in case of leaks, strictures or obstructions. In mild heart failure its solution is more feasible by not having to perform complex operations.

Make it easier to see the operation of the valves both radiographically and sonographically, because the shutter elements carry a metal part. For this, the materials used may carry mixtures of powder or metal particles.

To be able to place the valves in the veins or arteries of the members, in cases where there are great limitations for transplants or cardiac operations, because although some veins or arteries do not receive the irrigation correctly, it would be sufficient to improve the limit state or exceptional patient.

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Problem to solve

The current valves are complex, expensive and difficult to implant, you have to open the heart. Also in delicate diseases or in people of high age it is not possible to make such changes because it is very dangerous.

Description of the invention

The artificial cardiac or venous valve of placement in the veins and / or arteries external to the heart, in the place of the venous valve or in series with the damaged cardiac, consists of a single-piece retention valve constituted by a cylindrical or cylindrical cylindrical tubular element which carries an ovo-spherical or ogival sealing element of hydrodynamic or hemodynamic profile divided into at least two triangular sheets in the form of helmets or longitudinally arranged ovo-spherical sectors, whose outermost end oscillates perpendicular to the axis of symmetry, creating a variable opening nozzle, which opens allowing the passage of the blood flow in a direction when it is pressed or sucked by it and prevents its recoil when the pressure or suction ceases, joining and adapting the leaves laterally to each other . Said valve is placed in the veins and / or external arteries and near the heart or in the damaged veins. It has the ends of the bevelled and / or rounded tubular elements. They are also valid for artificial hearts.

The tubular element can be cylindrical with its central ovoidal zone.

The valves can be placed as follows: a) performing resection or internal removal of the valve if there is obstruction, b) introducing the valves that are very flexible or elastic by catheterization from the outside, compressing them and sending them through the veins or arteries , c) opening the thorax and introducing the valves into said veins or arteries, opening or sectioning them, d) fixing the valve to the inner wall of the veins or arteries by means of suture or subject and blocked by pressure and e) applying it as a bypass over a vein or artery. Point a) can be eliminated if there is no obstruction and the problem with the valve is the rupture of the valve leaflets and therefore the existence of leaks or regurgitation.

The ducts or tubular elements allow the total opening of the triangular blades of the ovo-spherical end.

The spherical ovo sheets may be covered by at least one layer or membrane of elastic, resistant and durable material. Some of the sheets may be reinforced internally or laterally with a mesh or fabric of natural or synthetic fibers. The surface of the ovo-spherical sheet and inside the duct is smooth. The ovo-spherical sheets may have at least one flange at its periphery, preferably two or three, to facilitate sealing. The sheets and the tubular elements can have in their composition a mixture of powder or metal particles to facilitate the observation of their operation.

Helmet-shaped sheets or ovo-spherical sectors, can be elastic, flexible, rigid and semi-rigid, have an oval end with rounded corners, can oscillate on the longitudinal axis by means of wires, strips or flexible internal reinforcing steel bands which also serve as support and allow to see its operation both radiographically and sonographically.

Rigid sheets inevitably need strapping at one end. Biocompatible and antithrombotic capacity materials should be used: Pyroltic carbon, stainless steel, cobalt and titanium alloys, graphene, polyester, acrylic, fluorocarbons (teflon), some silicones, polyamides, polyurethanes and polyethylenes. To suture an external band or tube of

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dacron velvet (polyethylene terephthalate or ethylene polyterephthalate). Other flexible or elastic materials based on rubber, polymers, latex, etc., and those already used, preferably biocompatible, can be used. The edge of the ovo-spherical sheets can be made of soft material, very elastic, resistant and durable.

Double valves can be placed with two shutter elements in series.

Flexible valves will be placed by catheterization, through 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 are not excessively brittle. They can also be placed inside the veins or arteries, without having to open the heart only the thorax and related membranes. They can be placed inside the heart, but this solution is less appropriate.

The lateral junctions of the ovo-spherical leaves with the duct are rounded, in this way the blood is never trapped at the junction corners between them.

The spherical ovo sheets can be joined to the duct forming a single piece, by gluing, suturing, rivets, bolts, thymes, tongue and groove, molded or thermally cast.

The spherical ovo sheets admit different thicknesses along their length, the most convenient being a decrease towards its end.

The tubular elements act of resistant and insulating shell of the valves, their inner walls can also 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. The widening prevents flow restriction. You can also place sausages or sutures at the ends of the arteries or veins. The suture is made inside the veins and arteries by a soft outer layer, mesh or biocompatible tissue of the tubular element.

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.

A variant presents the ovo-spherical end with at least two inverted leaflets, with the concavity outward, arranged longitudinally, whose outermost end extends with the blood pressure and retracts by coupling laterally to each other, when the pressure disappears, avoiding the Reflux.

In case of using two triangular blades or two leaflets, the anterior area of these may have transverse grooves that facilitate opening.

The valve can be divided into two halves and joined by threading, gluing, thermal melting, etc.

Flexible, but not elastic, valves carry an external stent so that once placed in place they extend and adapt to the veins or arteries.

To be able to introduce the valve by catheterization it is necessary that the tubular element and even the ovo-spherical sheet be elastic, compressible and expandable. The catheter transports the imprisoned and compressed valve by means of a fluted or internally grooved tubular element at its end acting as a clamp. The imprisoned valve is inserted and the valve is placed in its place inside the vein or artery with the catheter, and it is released or discharged by means of a rod and a knob that drive a plunger by pressing and pushing on the innermost end of the valve.

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Advantages: They are very simple, they supplement the heart's valvular functions, they do not produce the breakage of the red blood cells, they do not have internal axes of rotation in contact with the blood, friction does not occur. They are practical, very simple, economical, safe and allows duplicating the system to make them even safer. It allows very small sizes, only limited by the amount of flow to be sent. Some can be applied without having to open the chest, heart, etc. They can be used when operations have to be avoided which, due to their complication, are not advisable.

Brief description of the drawings

Figure 1 shows a schematic and sectioned view of the ovo-spherical leaf valve of the invention.

Figures 2 through 9 show schematic and sectioned views of variants of the valve of the invention.

Figure 10 shows a schematic and partially sectioned view of a valve of the invention with a portion of vein or artery.

Figure 11 shows a schematic perspective view of a valve variant.

Figure 11a shows a bypass valve applied over a vein or artery.

Figure 12 shows a schematic and partially sectioned view of a catheter applying a valve.

Figures 13 through 15 show schematic and partially sectioned views of hearts with variants of valves incorporated.

More detailed description of the invention

Figure 1 shows a form of realization of the invention, with the valve constituted by the tubular cylindrical element (1), which integrates the sealing element, of hydrodynamic profile, integrated internally by one end, with the other end divided into two or more triangular leaflets or blades in the form of helmets or ovo-spherical sectors (2) arranged longitudinally. The outermost ends of said leaflets can oscillate perpendicular to the axis of symmetry of the duct, creating a variable opening nozzle, which opens allowing the passage of the blood flow in one direction when pressed by it and prevents its recoil when the press and join and adapt the leaves laterally to each other. Optionally you can use the straps, sheets or steely reinforcing wires (60). The material may have a mixture of powder or metal particles.

Figure 2 shows the valve constituted by the tubular element (1 and 1a), which carries the ovo-spherical end integrated into its inner wall, divided into at least two triangular sheets in the form of helmets or ovo-spherical sectors (2) , creating the variable opening nozzle, with the steely reinforcing wires or sheets (6). The oval bulge (3) on the tubular element facilitates its attachment to the inside of the veins and arteries.

Figure 3 shows the valve constituted by the tubular element (1 and 1a), which carries the ovo-spherical end integrated into its inner wall, divided into two or more triangular sheets in the form of helmets or ovo-spherical sectors (2) , creating the variable opening nozzle, shows the steely reinforcing wires or sheets (6) and the assembly cover (7). The oval bulge (3) on the tubular element facilitates its attachment to the interior of the veins and arteries.

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Figure 4 shows the valve constituted by the tubular element (1 and 1a), which carries the ovo-spherical end integrated into its inner wall, divided into two or more triangular sheets in the form of helmets or ovo-spherical sectors (2) , creating the variable opening nozzle, shows the steel strips (6a) in the anterior area and the recesses (8). The hoops or optional springs (11), allow its extension. The oval bulge (3) on the tubular element facilitates its attachment to the interior of the veins and arteries.

Figure 5 shows the valve constituted by the tubular element (1 and 1a), which carries the ovo-spherical end integrated into its inner wall, divided into two or more triangular sheets in the form of helmets or ovo-spherical sectors (2) , creating the variable opening nozzle, shows the steely reinforcing wires or sheets (6) and the assembly cover (7). The oval bulge (3) on the tubular element facilitates its attachment to the interior of the veins and arteries.

Figure 6 shows the valve constituted by the tubular element (1 and 1a), which carries the ovo-spherical end integrated into its inner wall, divided into two or more triangular sheets in the form of helmets or ovo-spherical sectors (2) , creating the variable opening nozzle, shows the reinforcing steel strips or plates (6b) and the vein or artery (9) that covers the valve. The oval bulge (3) on the tubular element facilitates its attachment to the interior of the veins and arteries.

Figure 7 shows the valve constituted by the tubular element (1 and 1a), which carries the ovo-spherical end integrated into its inner wall, divided into two or more triangular sheets in the shape of helmets or oval sectors (2), creating The variable opening nozzle shows the cover of the assembly (7). The oval bulge (3) on the tubular element facilitates its attachment to the interior of the veins and arteries.

Figure 8 shows the double valve constituted by the tubular element (1), which carries the ovo-spherical end integrated into its inner wall, divided into two or more triangular sheets in the form of helmets or ovo-spherical sectors (2 and 2a ) of two valves. This can be covered in turn by an overlapping tubular element.

Figure 9 shows the valve constituted by the tubular element (1), which carries the ovo-spherical end integrated into its inner wall, divided into two or more triangular sheets in the form of helmets or ovo-spherical sectors, creating a nozzle of variable opening Add the straps, wires or steel reinforced reinforcement (6) and (60).

Figure 10 shows the valve constituted by the tubular element (1), which carries the ovo-spherical end integrated into its inner wall divided into two or more triangular sheets in the form of helmets or ovo-spherical sectors (2), creating the Variable opening nozzle adapted inside the vein or artery (9).

Figure 11 shows the valve constituted by the tubular element (1) portion of the tubular element or conduit and the leaflets (10) with the concavity outwards.

Figure 11a shows a section of duct (1b) which acts as a bypass and is embedded with its flute tip ends in a vein or artery (9) and carries inside it the valve of valves (2).

Figure 12 shows a flexible valve (14), compressed and held by its lateral faces by the cylindrical end (15) of the catheter (19), grooved or ribbed inside. Once the valve is placed in its place inside the vein or artery (9), it is released or discharged by means of the rod (17) and the control (18) that drive the plunger (16) by pressing and pushing on one end of the valve.

Figure 13 shows the valves (14 and 14a) constituted by cylindrical tubular elements which have the ovo-spherical sealing element divided into two or more triangular sheets in the form of hulls or oval-spherical sectors (2 and 2a), creating the variable opening nozzles, arranged inside the upper and lower cava veins 5 (9 and 9a), in series with the tricuspid valve, which it replaces without the need to eliminate it. If it were due to obstruction, it would be necessary to eliminate the valves of said valve by resection.

Figure 14 shows a heart with the valves (14 and 14a) with sealing elements of type 10 of helmets or ovo-spherical sectors, which are placed in the pulmonary arteries in series with the pulmonary sigmoid valve, without the need to cancel it . If it were due to obstruction, it would be necessary to eliminate the valves of said valve by resection.

Figure 15 shows a heart with the valve formed by the tubular element (1), which carries the ovo-spherical end integrated into its inner wall, divided into two or more triangular sheets in the form of helmets or ovo-spherical sectors ( 2), with the oval bulge (3) creating the variable opening nozzle, placed in the aorta (9) in series with the aortic sigmoid valve, without the need to cancel it. If it were due to obstruction, it would be necessary to eliminate the valves of said valve by resection.

Claims (23)

5 10 fifteen twenty 25 30 35 40 Four. Five fifty 1. Artificial cardiac or venous valve for placement in veins and / or arteries external to the heart, in the place of the venous valve or in series with the damaged cardiac, which consists of a single-piece retention valve constituted by a cylindrical tubular element or ovoidal cylindrical which carries at one end an ovo-spherical or ogival sealing element of hydrodynamic or hemodynamic profile divided into at least two triangular sheets in the form of helmets or longitudinally arranged ovo-spherical sectors, whose outermost end oscillates perpendicular to the axis of symmetry , creating a variable opening nozzle, which opens allowing the passage of the blood flow in one direction when it is pressed or sucked by it and prevents its recoil when the pressure or suction ceases, joining and adapting the leaves laterally to each other, ends of the tubular elements are beveled and / or rounded. 2. Valve according to claim 1, characterized in that the tubular element is cylindrical. 3. Valve according to claim 1, characterized in that the tubular element is cylindrical at the ends and ovoidal in the central area. 4. Valve according to claim 1, characterized in that the shell-shaped sheets or ovo-spherical sectors are covered by at least one layer or membrane of elastic, resistant and durable material. 5. Valve according to claim 4, characterized in that the sheets in the form of helmets or ovo-spherical sectors are reinforced internally or laterally with a mesh or fabric of natural or synthetic fibers. 6. Valve according to claim 1, characterized in that the hull-shaped leaves or ovo-spherical sectors have at least one flange on their periphery. 7. Valve according to claim 1, characterized in that the ovo-spherical sheets are flexible or semi-rigid elastic and are reinforced internally and longitudinally by means of flexible steel wires, strips or bands that serve as support and allow to see their operation both radiographically and sonographically. 8. Valve according to claim 1, characterized in that the leaves of the valve are rigid and have a strap in their anterior area that joins them to a support or conduit. 9. Valve according to claim 1, characterized in that the valve is made of biocompatible, stainless and antithrombotic capacity materials: pyrolytic carbon, stainless steel, cobalt and titanium alloys, or based on polyester, acrylic, fluorocarbon (teflon) polymers, some silicones , polyamides, polyurethanes and polyethylenes, rubber, latex, graphene or metal alloys. 10. Valve according to claim 1, characterized in that the edge of the leaves in the form of ovo-spherical sectors is made of soft, elastic, resistant and durable material. 11. Valve according to claim 1, characterized in that double valves consisting of two sealing elements in series are placed. 12. Valve according to claim 1, characterized in that the tubular element acts as a resistant and insulating housing of the valve and its inner wall is resistant and elastic. 5 10 fifteen twenty 25 30 35 13. Valve according to claim 1, characterized in that the fastening of the valve is effected by suturing inside the veins and arteries by means of an external band or tube of dacron velvet (polyethylene terephthalate or ethylene polyterephthalate). 14. Valve according to claim 1, characterized in that the lateral joints of the hull-shaped leaves or ovo-spherical sectors with the tubular element are rounded. 15. Valve according to claim 1, characterized in that the hull-shaped leaves or ovo-spherical sectors are joined to the tubular element forming a single piece, by gluing, suturing, rivets, bolts, thymes, tongue and groove, molded or thermally cast. 16. Valve according to claim 1, characterized in that the valve assembly is coated with a layer of elastic and / or protective material, resulting externally in a single piece element. 17. Valve according to claim 1, characterized in that the tubular element has strips, sheets or steely reinforcing wires inside. 18. Valve according to claim 1, characterized in that the shell-shaped sheets or ovo-spherical sectors admit different thicknesses along their length. 19. Valve according to claim 1, characterized in that the tubular element is formed by two halves and is joined by threading, gluing or thermal melting. 20. Valve according to claim 1, characterized in that a catheter is used to transport the compressed and compressed elastic valve at the cylindrical end thereof which is grooved or grooved internally, carrying a rod and a release knob that drive a plunger by pressing and pushing on the inner end of the valve. 21. Valve according to claim 1, characterized in that the valve is flexible, but not elastic, carries an external stent so that once placed in its place it extends and adapts. 22. Valve according to claim 1, characterized in that the leaves and tubular elements of the valve have in their composition a mixture of powder or metal particles. 23. Valve according to claim 1, characterized in that the valve of helmets or ovo-spherical sectors (2) is mounted in a duct (1b) that acts as a bypass over a section of vein or artery, in which it is embedded with its ends in flute tip