ES2357061B1 - ARTIFICIAL CARDIAC VALVE. - Google Patents

Abstract

The artificial cardiac valve consists of a portion of a 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. placed 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 tubular element can be of semi-oval, semicircular or rectangular-semicircular section and all of them with rounded corners. The tongues may be covered by at least one membrane of elastic material, resistant and durable. Some of them may be reinforced internally or laterally with a mesh or fabric of natural or synthetic fibers. The tabs can be flexible, rigid semi-rigid and have a semi-oval or semi-oval rectangle shape with their rounded corners.

Description

rectangle with a semi-oval end, with its es-

Arti fi cial heart valve.

Field of the Invention

In the replacement or complementation of heart valves and in artificial hearts. State of the art

Currently, the arti fi cial valves are complicated, they destroy the 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. Object of the invention

Simultaneously provide a simple, economical, durable and safe valve.

Provide a valve with a longitudinally 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 smallness, 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 suf fi cient to improve the limit or exceptional state of the patient.

Provide a tongue with two floating axes 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 arti fi cial heart valve of the invention consists of a portion of tubular element, or conduit, which carries an oscillating tongue or tongue, longitudinally positioned, inclined with respect to the internal or attached wall by its flat or anterior end. 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 may 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 elastic, rounded kin, and can be slightly curved transversely, can oscillate around the peripheral, straight or large curvature anterior end by means of internal reinforcing steel fl axis or fl exible bands 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 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 arteries 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 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 least 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. Catheter

3 EN 2357061A1 4

transport the compressed valve for 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 wall of the duct 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, chrome-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, 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 internal carrier, and secured by the front end, the oscillating tongue (2) positioned inclined, of longitudinally hydrodynamic profile, the which allows the flow of blood flow in one direction and prevents it in the opposite direction, the fi laments

or steel wires (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 fl axis-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 and inclined tongue (2), 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 duct widening (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 inserted 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 hoops

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 and inclined tongue portion (2c), which oscillates around the axis (15) with the opposition of the fl axis 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 arcuate tongue (2).

Figure 12 shows the semicircular section duct (1) and the tongue (2) adapted to the walls of the duct and in the closed position, rotates around the 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 on the front edge) ) 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 hydrodynamic profile longitudinally. 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) on the axis of the duct.

Figure 16 shows the duct (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 valves.

5 EN 2357061A1 6

Claims (23)

one.

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 (1), which carries integrated to its inner wall or held by the anterior end, at least one tongue or oscillating tongue (2), of longitudinally hydrodynamic profile, positioned inclined with respect to the longitudinal axis of the conduit, which allows the passage of the blood fl ow in one direction when pressed by it and prevents its recoil when adapting to the interior of the conduit.

2.

Valve according to claim 1, characterized in that the tongues oscillate around the straight front end or of great curvature by means of a fl axis

or fl exible band of internal reinforcing steel (5a) that also serves as support.

3.

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

Four.

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 section with a rectangular end and the other semicircular.

6.

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

7.

Valve according to claim 6, characterized in that the tongues are covered with at least one membrane and are reinforced internally or laterally with a natural or synthetic mesh or fabric.

8.

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

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 curved transversely.

eleven.

Valve according to claim 1, characterized in that the tabs are rigid and oscillate around the straight front end or of great curvature by means of an axis (22).

12.

Valve according to claim 1, characterized in that the tabs are semi-rigid and oscillate around the straight front end or of great curvature by means of an axis (15).

13.

Valve according to claim 1, characterized in that the valve is constituted with at least one of the following biocompatible materials, with antithrombotic capacity, metal alloys, cobalt and titanium alloys, steel, polyester, acrylics, fluorocarbons (teflon), some silicones,

It is because the face of the tongue that contacts the conduit when closed is made of soft, elastic material, and has at least one flange along its periphery.

fifteen.

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 grasped and compressed by means of a catheter in three or more external 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 base of 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 in that the duct has a widening at the height of the tongue so that the blood flow is greater.

twenty.

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

twenty-one.

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 conduit is coated externally with a fabric of natural or synthetic fibers to facilitate sewing to veins and arteries.

2. 3.

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 the 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 in which a semi-oval or rectangle-shaped tongue with a semioval end, has an eccentric anterior area of the Tongue a shaft with two very bulky ends which move very loosely in two 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 blood.

 ES 2 357 061 A1    ES 2 357061 A1    ES 2 357 061 A1    ES 2 357061 A1   SPANISH OFFICE OF THE PATENTS AND BRAND Application no .: 200800426 SPAIN Date of submission of the application: 13.02.2008 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: A61F2 / 24 (01.01.2006) RELEVANT DOCUMENTS

Category

Documents cited Claims Affected

X

US 2003055492 A1 (SHAOLIAN et al.) 20.03.2003, paragraphs [40-88]; figures. 1-24

X

US 2004 260390 A1 (SARAC et al.) 23.12.2004, paragraphs [133-170]; Figures 14-28. 2. 3

TO

1-8,10,13,16,20-22

X

US 3926215 A (MACLEOD) 16.12.1975, the entire document. 1,3-5,8-13,18-19

X

US 2006058889 A1 (CASE et al.) 16.03.2006, paragraphs [28-69]; figures. 1,3-5,8,13,16,20

X

US 5358518 A (CAMILLI) 25.10.1994, column 1, line 50 - column 2, line 62; Figures 1-2B. 1.3-9.13.20

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the date of priority submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of realization of the report 04.03.2011

Examiner J. Square Prados Page 1/2

REPORT OF THE STATE OF THE TECHNIQUE Application number: 200800426 Minimum documentation sought (classification system followed by classification symbols) A61F Electronic databases consulted during the search (name of the database and, if possible, terms of search used) INVENES, EPODOC, WPI, PAJ, ECLA. State of the Art Report Page 2/2