RU2393817C2 - External support for competence recovery of venous valve by intracommisure wall dilatation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine and can be used for competence recovery of venous valve. A support comprises a back, or a recessed wall, and a front, or a surface wall; its external support consists of a pattern of two arched frame enclosures with longitudinal sides made of an elastic and flexible extensible material. The back enclosure includes two branches passing through to insert said back frame enclosure behind the posterior venous wall by two canals and has the eared tops. The front enclosure has a proximal eared fold and a distal eared fold. Each frame enclosure includes a free-ended longitudinal side working in tension and consisting of straight branches. The frame enclosures with their longitudinal sides form a junction surrounding the vein ensured by passage of the branches working in tension with the free end of said back frame enclosure through the ears of said front frame enclosure and by passage of the branches working in tension with the free end of the front enclosure through the ears of said back enclosure.

EFFECT: enabled treatment within vein fusion.

3 dwg

Description

The invention relates to a device for restoring the competence of venous valves.

A device for restoring the competence of venous valves is known from international application No. WO 97/40755 (author Zhukovsky), published November 6, 1997 under the name “Device for restoring the competence of venous valves”, which is the closest prototype.

Zhukovsky’s device is based on the discovery that an external force applied to a vein at the level of the approaching surfaces of an incompetent, weakened valve of such a vein smooths the vein in order to extend the valve flaps to the sides, thus choosing weakness and bringing them together, restoring, thus the vein competence.

Thus, Zhukovsky’s device acts as a support, providing a compressive corrective force to an incompetent vein.

Zhukovsky discloses a support having a pair of identical, usually rectangular compression-mounted membranes installed on opposite sides. The membranes may be oval or arched in shape or may be flat with curved ends; they form a connection with the help of an intermediate hinge part which is integral with them, which, after placing the support around the valve, generally stretches axially relative to the vein and is placed next to one of the adhesions where the valve flaps attached to the opposite walls of the vein meet; the compression force applied by the support to the valve is determined by the width of the hinge. The device is implanted by stitching the free edges of two rectangular elements. The joints perform the same function as the hinge, and they can adjust the compression force of the device on the venous walls by the degree of their contraction.

There are problems with the Zhukovsky device.

Zhukovsky’s device has two compression membranes that are continuous surfaces. Due to this continuity, for their implantation, it is necessary to completely clear the posterior wall of the vein from surrounding tissues and from all possible collateral veins. In addition, for the same reason, due to the asymmetry and anatomical variability of the merger itself, it is inconvenient to treat an incompetent valve located at the confluence with another vein.

In addition, the external compression provided by the Zhukovsky device does not actually guarantee a simultaneous increase in the interspike diameter. The disadvantage of Zhukovsky’s device is that its compressive effect is virtually unreliable in terms of its corrective action.

In fact, there is no certainty that the application of anteroposterior compressive forces while decreasing the anteroposterior diameter of the vein necessarily determines an increase in the lateral-lateral interspike diameter of the venous valve because it occurs in vivo: depending on the usually occurring contraction of the muscle component of the venous wall during surgical cutting of the vein from the surrounding tissues; depending on the blood pressure inside the vein and depending on whether the contraction of the muscle component of the venous wall is caused by a hormone or a medicine, the vein is not in its final state, as the essence of Zhukovsky’s device actually suggests, so its calibration is difficult and probably incorrect.

In addition, the venous spasm immediately following the surgical intervention reduces the diameter of the blood vessel around the circumference, so that it is impossible to approximate the two valve cusps in the best way and therefore it is impossible to verify the competence of the valve intraoperatively, i.e. during surgery.

The aim of the present invention is a device for restoring the competence of venous valves, which solves such problems.

This goal is achieved using an external support.

Among the main differences between the support of the present invention and the Zhukovsky device is that (a) the support claimed in the present invention works in tension and not in compression; (b) this device is made in the form of a frame shell, and not in the form of continuous membranes; (c) its really working parts in tension are the sutures made by the surgeon, in contrast to the Zhukovsky device, which only requires that the sutures be closed.

Preferred embodiments of the present invention are set forth in the dependent claims.

An advantage of the external support of the present invention is that it can be inserted after extremely simple dissection with the implementation of a rear or in-depth passage tunnel. The surgeon only has to prepare two canals without dissecting the vein over the entire length of the device. The device can be inserted into these channels with easily inserted elongated branches. Since the size of the dissection is smaller than in Zhukovsky’s device, the accompanying venous spasm is also smaller. This increases the significance of the known manipulation of milking, which with spasm is less reliable or not feasible at all.

The invention will be easier to understand based on the following detailed description of preferred embodiments of the present invention, given with reference to the accompanying drawings.

Figure 1 and Figure 1A respectively show the rear and front frame shells of the claimed external support according to a preferred embodiment of the present invention.

Figure 2 shows two frame shells according to figures 1 and 1A, which together form a connection with each other with the formation of an ellipsoidal inner tunnel forming a vein.

Figure 3 schematically shows a vein restored to its competent state by stretching the inter-spike walls of its valve by means of the declared external support, drawn by sutures to the same inter-spike walls.

The external support includes two arcuate frame shells of extendable material, respectively, the rear or in-depth frame shell 1 (see Figure 1), and the front or surface frame shell 1A (see Figure 2). The external support is intended for implantation around the vein in the longitudinal direction, that is, along the length of the vein.

Two frame shells must perform different functions.

The posterior skeleton sheath 1 includes proximal and distal through branches of extendable material for easy insertion of the posterior skeleton sheath behind the posterior venous wall through two channels prepared by the surgeon, without the need for ligatures on possible collateral veins. Easily inserted branches according to the preferred embodiment of the present invention depicted in the drawings are made in the form of proximal and distal narrow bends 2, 3 of an elongated material with vertices made in the form of ears 2 ', 3'. Narrow bends 2, 3 continuously pass one into another with the formation of a central bend 4.

The front frame shell 1A has the same structure as the rear frame shell 1, with a proximal bend 2A with the eyelet 2'A; distal bend 3A with the eye 3'A and the central bend 4A, but the proximal and distal bends should not be through.

The arcuate configuration of the two frame shells has a corresponding longitudinal tensile side. Such tensile parties include corresponding longitudinal rectilinear lateral branches operating in tension from elongate material. According to a preferred embodiment of the present invention, as shown in Figures 1 and 1A, the tensile branches are branches with free ends 5, 5 ′ for the rear frame shell 1 and 5A, 5′A for the front frame shell 1A. Tensile branches with free ends 5; 5A; 5 ', 5'A, respectively, are formed as a continuation of the proximal branches 2p; 2Ar and distal branches 3d; 3Ad proximal 2, 2A and distal 3, 3A bends of the front 1 and rear 1A frame shells, respectively. The central bends 4, 4A reach the level of the longitudinal side working in tension, the arcuate configuration of the frame shells. The configuration with the free ends of the branches working in tension serves to provide elasticity in order to increase flexibility in the longitudinal direction.

Two skeleton shells should form a connection with each other around the vein, the defect of which will be eliminated by the sides of the arched configurations of the shells by turning their concave sections to each other to obtain support in the assembly, as shown in Figure 3, with the formation of an ellipsoid tunnel around the vein V. In the Figure 2 shows the outer support S assembly. In accordance with this preferred embodiment of the present invention, the carcass shells are assembled by passing tensile branches with the free ends 5, 5 ′ of the rear carcass shell 1, through the ears 2'A, 3'A of the front carcass shell 1A, and passing the branches, working in tension, with the free ends 5A, 5'A of the front frame shell 1A through the ears 2 ', 3' of the rear frame shell 1. Thus, the ears form a mechanical relationship of the frame shells.

The external support has a proximal portion formed by the proximal branches 2p, 2Ar, and a distal portion formed by the distal branches 3d, 3Ad, and a central portion between them. The front-back diameter of the support can be reduced from the central portion to the proximal and distal portions to emulate the normal anatomical shape of the natural valves, which contributes to the hemodynamic closure of the valves.

The proximal branch 2p of the posterior frame shell 1 may be curved outward, as shown in Figure 1, while the proximal branch 2Ar of the anterior framework 1A may be curved outwardly, as shown in Figure 1A. Thus, the external support assembled from the frame shells 1, 1A, as shown in Figure 2, has an inclined neck 2p, 2Ap, which can adapt to the confluence of two veins at the proximal section.

Figure 3 shows that the claimed external support is installed around the vein V with longitudinal sides working in tension of two frame shells located respectively from opposite interspike valve walls iw1, iw2. It regulates the restoration of the correct convergence of incompetent valve flaps, choosing their weakness by stretching. A tensile force is applied to the interspike walls iw1, iw2 of the venous valve bulb through the known surgical sutures s1, s2 and exerts pressure along the interspike diameter, i.e. along the cusps of the valve c1, c2, in order to expand it, stretching the cusps and choosing their slack. Surgical sutures s1, s2 respectively attract tensile branches, 5, 5 '; 5A, 5'A to the opposite interspike walls iw1, iw2. Surgical sutures can also attract the central bends 4, 4A of the frame shells, extending to the longitudinal sides of the frame shells, working in tension. In Figure 3, the eccentric ellipsoidal configuration of the vein V, which usually has a circular cross section, under the action of the claimed support presents the effect of stretching the latter, once drawn by sutures to the same interspike walls.

Hooks can be provided on the sides of one frame shell or both frame shells to ensure that the venous wall contacts the opposing interspike valve walls to increase the spike diameter by stretching. Hooks perform the same function as the seams, that is, they provide tension.

In another embodiment of the present invention, the carcass shells can be integrally formed by forming a joint with a hinge along the longitudinal side.

A metal wire with good flexibility and elasticity, such as Nitinol®, or medical grade AISI 316 steel, can be used as an extendible material.

However, biologically compatible plastic, for example tetrafluoroethylene such as Teflon®, polypropylene, polyethylene, can also be used as an extendable material.

This invention is disclosed with the help of certain variants of its implementation, but it should be understood that changes can be made to it, which are not deviations from the scope of its protection, which can be limited only by the attached claims.

Claims (1)

Tensile external support (S) to restore valvular competency of the veins, including weakened venous valves with leaflets, interspike walls and interspike diameter, for implantation around the vein (V) along its length; a vein includes a posterior or recessed wall and an anterior or superficial wall; its external support consists of a combination of two arcuate frame shells (1, 1A) with longitudinal sides of elastic and flexible extendable material, while the frame shells are, respectively, the rear or recessed frame shell (1), and the front or surface frame shell ( 1A), wherein said posterior carcass sheath (1) includes two passing through branches (2, 3) of said extendable material for inserting this posterior carcass sheath (1) behind the posterior venous wall (V) in two channels llama and has the tops in the form of ears (2 ′, 3 ′), while the aforementioned front frame shell (1A) has a proximal fold (2A) with the eyelet (2′A) and a distal fold (3A) with the eyelet (3′A) and each frame shell (1, 1A) includes a corresponding side working in tension, consisting of working in tension rectilinear branches of the longitudinal side with a free end (5, 5 ′; 5A, 5′A), while the two frame the shells (1, 2) form a connection with each other around the vein (V) with their longitudinal sides, due to the passage of workers on astyazhenie branches of the free end above the rear casing frame through eyelets aforementioned front frame shell, as well as by passing the tensile branches of the free end of the front casing frame through the rear frame tabs above the shell; said stretching parties are configured to come into contact with a vein (V) in the region of opposing interspike valve walls (iw1, iw2) by means of surgical sutures (s1, s2) to increase the interspike diameter of the vein (V) by stretching to select a weakened incompetent venous valve with the possibility of stretching its valves (c1, c2).

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