WO2008044958A1

WO2008044958A1 - Frameless aortic root prosthesis

Info

Publication number: WO2008044958A1
Application number: PCT/RU2006/000525
Authority: WO
Inventors: Yevgeniy Vladimirovich Rosseykin
Original assignee: Rosseykin Yevgeniy Vladimirovi
Priority date: 2006-10-11
Filing date: 2006-10-11
Publication date: 2008-04-17

Abstract

The invention relates to cardiosurgery, in particular to the aortic root. The aim of said invention is to produce a frameless aortic root prosthesis made of a plastic material which is devoid of negative properties of biomaterials and the shape of which is closest to the shape of the natural aortic root. The inventive frameless aortic root prosthesis comprises a tubular body which is provided with a bulging and is formed by rigidly connecting three modules, to the top and lower ends of which synthetic vascular implants are fastened. Each module consists of internal and external elements, wherein the external element is made of a synthetic material, the thickness of which ranges from 0.6 to1.0 mm and the shape and the size of said element correspond to the shape and size of the aortic root sinus, the external element is provided with two halves of a sub-commissural region and one third of the fibrous base of the aortic root, the internal element is sutured to the internal wall of the external element along a line which corresponds to the line of fixation of cusps of the aortic root to the line of a fibrous ring and is made of a synthetic material, the thickness of which ranges from 0.1 to 0.3 mm, and the vascular implant is sutured to the lower end and has the diameter of 22-26 mm and the width of 5 mm. The modules and the elements thereof are connected to each other by suturing technique.

Description

Frameless prosthesis of the aortic root.

The invention relates to cardiac surgery and relates to the aortic root.

Known aortic roots (KA) used in cardiac surgery, taken either from animals - a xenograft (KG), or from a human corpse - a homograph (GG). (Ross DN. Nomograft rlacemet of of the aortis valve. Lappet 1962; 2: 447).

The disadvantages of CG and GG are: complex search and procurement, requiring large personnel and material costs, the use of expensive equipment for high-tech processes to give CG and GG immunoneutrality and anticalcium processing, special refinement of CG and GG to a form that can be used in the clinic, the difficulty of creating KG and GG cans of the required size, limited shelf life, high degree of calcification when used, limited use in children and young people due to the extremely HIGH-risk of severe calcification, high reoperation to replace them, associated with dysfunction of the valve due to calcification and development of aortic valve insufficiency

Known frameless bioprosthesis of the aortic valve, made of the valve of the aortic complex of a mammal, containing a tubular body and a locking multi-leaf element adjacent to the end of the tubular body (see US patent JN ^* 2 4443895, 1984)

The disadvantages of the known bioprosthesis should include the fact that it is difficult to create a bank of bioprostheses of the required size, as well as high calcification when using them.

Known frameless bioprosthesis of the aortic valve, made from the valve-aortic complex of a mammal, containing a tubular body with ends, locking a multifold element adjacent to the end of the tubular body, while the valve flaps are made symmetrical due to excision of the muscle shaft of the right coronary leaf of the complex, the base of the right coronary leaf and the lower third of the right coronary sinus of the prosthesis made of fibrous tissue, which is their inner and outer layer, and the lower third of the right coronary sinus additionally has an outer skin made of one layer of biocompatible material (see Pat. 2175858 A61F2 / 24 2001).

The disadvantages of the known frameless bioprosthesis are the difficulty of creating, a limited shelf life, a high probability of calcification and repeated operations in the long term.

The basis of the invention is the task of creating a frameless prosthesis of the aortic root from a synthetic material that does not have negative properties of biomaterials, and the shape of which is as close as possible to the shape of the natural aortic root of a person. This goal is achieved by the fact that the frameless prosthesis of the aortic root, including a tubular body with protrusions, formed by a rigid connection of three modules, to the upper and lower ends of which vascular prostheses made of synthetic material are fixed. Moreover, each module consists of external (NEM) and internal (VEM) elements. The external element of the module is made of synthetic material with a thickness of 0.6 - 1.0 mm, and the shape and size of the external element of the module corresponds to the shape and size of the sinus of the aortic root with two halves of the subcommissural space and 1/3 of the fibrous base of the aortic root. The internal element of the module ^"is hemmed to the inner wall of the external element of the module along the line corresponding to the line of attachment of the valves of the aortic root to the line

SUBSTITUTE SHEET (RULE 26) fibrous ring and is made of synthetic material with a thickness of 0.1-0.3 mm. The vascular prosthesis hemmed to the upper end has a diameter of 26 mm and a length L of 25 mm (Fig. 1), and the vascular prosthesis hemmed to the lower end has a diameter of 22-26 mm and a width (length I) of 5 mm (Fig. 1) ) The connection of modules and module elements between themselves is carried out by stitching. Thus, the claimed frameless prosthesis of the aortic root meets the criteria of the invention of "novelty."

A comparison of the claimed frameless prosthesis of the aortic root with the known ones shows that the biological material has been replaced with synthetic material and sashes and sinuses of the aortic root have been found with which it is only possible to construct a frameless prosthesis of the aortic root, which eliminates the degeneration of biological tissue. The technical result is expressed in an increase in the operating life due to the lack of calcification of the frameless prosthesis of the aortic root due to the use of synthetic materials, in contrast to the valve-aortic complex of a mammal. In adjacent areas, no solutions have been identified that have signs that match the distinguishing features of the claimed frameless prosthesis of the aortic root, and the influence of the distinguishing features on the technical result indicated by the applicant is confirmed, and therefore, satisfies the criterion of "inventive step".

The invention is illustrated by drawings: In Fig.1 - a General view of a frameless prosthesis of the aortic root In Fig. 2 - the external element of the module (NEM) - corresponds to the shape and size of the sinus of the aortic root.

In Fig.Z - the internal element of the module (VEM) - corresponds to the shape of the leaflet of the aortic root

In FIG. 4 - frameless prosthesis of the aortic root from above

SUBSTITUTE SHEET (RULE 26) In FIG. 5 - frameless prosthesis of the aortic root from below

Figure 6 - form of the sinus of the aortic root

The frameless prosthesis of the aortic root is a tubular body 1 with protrusions (Fig. 1), formed by a rigid connection of three modules, each of which consists of two elements: external (Fig. 2) and internal (Fig. 3). The external element of the module is made in the form of a rectangle 2 (Fig. 2) of synthetic material, 0.6-1.0 mm thick with an internal marking line 3 (Fig. 2), which is the line of the fibrous ring, i.e. the line of attachment of the leaflet of the aortic root and it is applied in the form of a sine 4 of the aortic root (Fig.6). The lower point 5 (figure 2) of the internal marking line 3 (figure 2) is located at a distance of 5 mm from the lower edge 6 (figure 2) of the rectangle 2 (figure 2). The extreme lateral point 7, the internal marking line 3, is 2 mm from the lateral edge 8, rectangle 2. The rectangular part 9, rectangle 2, which is lower than the internal marking line 3, is 1/3 of the fibrous base 10 of the aortic root (Fig. 1 ) The rest of the rectangle 2, under the internal marking line 3 is two Vg (half) 11 (Fig.2) of the subcommissural space 12 (Fig.l) and two Vg (halves) 13 (Fig.2) of the commissure 14 (Fig.l).

The internal element of the module is made in the form of the sash 15 (Fig.Z) of a synthetic material with a thickness of 0.1-0.3 mm.

Assembly of the same type of modules of a frameless prosthesis of the aortic root.

We superimpose the internal element of the module (Fig. 3) on the external element of the module (Fig. 2) and connect them by stitching using synthetic threads. We sew in such a way that points 5, 16 are aligned with each other; 18, 20; 17, 19. The internal element of the module (Fig. 3) is connected to the external (Fig. 2) along the internal marking line 3

SUBSTITUTE SHEET (RULE 26) (Fig. 2), starting from the lowest point 5 (Fig. 2), which should correspond to the lowest point 16 (Fig. 3) of the sash 15.

Then we proceed to the assembly of a frameless prosthesis of the aortic root from three modules of the same type.

Combine the two modules so that the internal element of the module (Fig.Z) is inside. We sew the modules together along the outer edge 8 (Fig. 2) so as to combine points 23, 24 with points 21, 22 and points 20, 18 and 19, 17, respectively, of two stitched modules, i.e. points 18, 23 and 20.24 of one module must correspond to points 17, 21 and 19, 22 of the second module. In this way, a commissure 14 is formed (FIG. 1). Next, the modules are stitched along the line of points 20, 26 (figure 2) of one module corresponding to the line of points 19, 25 of the second module.

Similarly, the edges of the first and third and second and third modules are stitched together.

The remains of the external elements of the modules are cut off along the dashed line 27 (Fig. 2), which will be the upper edge of the connected modules (Fig. 1) and corresponds to 1/3 of the sinotubular crest (Fig. 1) - the upper end 28 (Fig. 1). To the lower edge of the formed form by connecting the modules, i.e. to the lower end 29 (Fig. 1), a vascular prosthesis 30 (Fig. 1) is sutured with a diameter of 22-26 mm and a width of 5 mm (length /) (Fig. 1), starting with three fixing sutures, connecting the lower points of the joints of the NEM and VEM modules 31 (FIG. 1) with three points located on the vascular prosthesis 30 (FIG. 1) at an equal distance from each other. Hemming of every third goes from the junction of the NEM and the VEM modules 31 (Fig. 1) to the center from two sides, taking into account the difference in lengths of the objects being sewn together.

SUBSTITUTE SHEET (RULE 26) Similarly, to the upper edge of the connected modules 28 (FIG. 1), i.e. a vascular prosthesis 32 (Fig. 1) with a diameter of 26 mm is hemmed to the upper end 28 (Fig. 1), starting with three fixing sutures connecting the upper points of the joints of the modules 33 (Fig. 1) and three points on the vascular prosthesis 32 (Fig. 1) equally spaced from each other. The length of the vascular prosthesis 32 (Fig. 1) is 25 mm (length L).

The result is a tubular body with three protrusions 34 (Fig.l).

The frameless prosthesis of the aortic root is completely cut out of synthetic material and all connections are made with synthetic thread.

The use of synthetic material, which has proven itself in various positions of the cardiovascular system (vascular prostheses, patches during reconstructive operations inside the heart), avoids calcification of the frameless prosthesis of the aortic root.

The use of the forms of the leaflet and sinus of the aortic roots, as well as the modular approach to create a prosthesis of the aortic root, made it possible to construct a symmetrical prosthesis of the aortic root, which in its form was as close as possible to the shape of the natural aortic root of a person. The maximally approximate form of the aortic root allows one to count on the hemodynamic characteristics of a given prosthesis of the aortic root close to the work of the human aortic root.

SUBSTITUTE SHEET (RULE 26)

Claims

Claim

1. Frameless prosthesis of the aortic root, including a tubular body with protrusions, formed by a rigid connection of three modules, to the upper and lower ends of which vascular prostheses of synthetic material are fixed, each module consisting of external and internal elements, the external element is made of synthetic material with a thickness 0.6 - 1.0 mm, the shape and size of the outer element corresponds to the shape and size of the sinus of the aortic root, with two halves of the subcommissural space and one third of the fibrous base of the aortic root, the inner element is hemmed to the inner wall of the outer element along the line corresponding to the line of attachment of the leaflets of the aortic root to the line of the fibrous ring and is made of synthetic material with a thickness of 0.1 - 0.3 mm, the vascular prosthesis sewn to the upper end has a diameter 26 mm and a length of 25 mm., And the vascular prosthesis hemmed to the lower end has a diameter of 22 - 26 mm. and a width of 5 mm.

2. Frameless prosthesis of the aortic root according to claim 1, characterized in that the connection of the modules and their elements is carried out by stitching.

SUBSTITUTE SHEET (RULE 26)