RU2314041C2 - Aortic valve cusps replacement method and pattern for performing the same - Google Patents

Abstract

FIELD: medicine, in particular, cardiac surgery.

SUBSTANCE: method involves using patches of synthetic cloths or xenopericardium as cusps patterns; cutting patches according to pattern for forming of aortic valve cusps; initiating cusps replacement process in the region between lowermost point of cusp pattern and lowermost point of fibrous semilunar region; continuing fixing of cusp pattern from the bottom to the top up to the site 5 mm spaced from upper point of semilunar region and to protruding part of neocusps; forming three new aortic valve commissures. Pattern for cutting of aortic valve cusps is formed as 155-deg segment of circle having radius of 1.7-1.9 cm and made from stainless steel. Pattern is provided with protruding parts for fixing of cusps. Apparatus for measuring length of fibrous semilunar region is manufactured from stainless steel and made in the form of inverted Ω. It is equipped with 0-62 mm scale. There is opening at position corresponding to "0" for attaching pattern to upper point of commissure.

EFFECT: simplified replacement of aortic valve cusps, reduced probability for degrading of autopericardium, provision for predictable procedure and standardized operation steps.

4 cl, 8 dwg, 1 ex

Description

The invention relates to cardiac surgery and relates to devices for prosthetics of aortic valve cusps and a method for its implementation.

A known method of prosthetics of aortic valve cusps, which includes excising aortic valve cusps, preparing an autopericardium using a 0.5% glutaraldehyde solution, and cutting out cusps from it according to a previously available complex pattern that is performed in three sizes, depending on the diameter of the aortic valve . The aortic valve leaflet prosthesis prepared in this way is fixed with six sutures, three at the deepest point of the fibrous half moon and three to each of the commissures. Then they finish by sequentially sewing all the leaves (Duran CMG (AORTIC VALVE REPLACEMENT WITH FREEHAND AUTOLOGOUS PERICARDIUM, J Thoras Cardiovasc Surg 1995; 110: 511-516, prototype).

The disadvantages of the method are: the lack of pre-prepared material for reconstruction, the need to prepare the valves during surgery, autopericardium treated with a solution of glutaraldehyde, often undergoes calcification and deregulation in the long term, which leads to aortic insufficiency, unpredictability of the result of the operation due to the complex structure of the aortic root and its some asymmetry, because of which it is not always possible to stitch the prepared identical strings to fibrous half moons having initial spread in their length.

A complex template for sash cutting is known, which is made in three sizes depending on the diameter of the aortic valve (Duran CMG (AORTIC VALVE REPLACEMENT WITH FREEHAND AUTOLOGOUS PERICARDIUM, J Thoras Cardiovasc Surg 1995; 110: 511-516, prototype).

The disadvantage of this template is the complexity of its shape and the difficulty of its manufacture.

In the known method of prosthetics of the valves of the aortic valve, a mold for measuring the length of the fibrous crescent is not used, because the authors were not asked to measure it. However, measuring the length of the fibrous crescent moon is the cornerstone for solving the issue of prosthetics of the valves of the aortic valve, because the leaflets made according to the template are symmetrical, and the fibrous crescent to which they are sewn with symmetrical forms in the natural aortic valve are not, i.e. the length of the three fibrous half moon differs from each other. In principle, it is possible to carry out a similar procedure if the difference in the lengths of the fibrous half moon does not differ by more than 4 mm. Otherwise, the prosthesis of the valves can lead to insufficiency of the aortic valve due to the poor closure of new valves, i.e. makes this procedure unpredictable. In the known world literature there is no data on the instrument for measuring the length of the fibrous half moon.

The aim of the proposed method and devices is to simplify the prosthetics of the valves of the aortic valve, predict the result of the operation, as well as reduce the likelihood of degeneration of the autopericardium by replacing it with synthetic material or xenopericardium.

This goal is achieved by the fact that in the method 1) first, the affected leaves are excised; 2) the diameter of the aortic valve is measured with standard gauges of the diameter of the fibrous ring, and if the diameter is in the range of 21-26 mm, this operation is possible; 3) impose three seam-holders with synthetic thread through the upper points of each commissure; 4) measure the length of the three fibrous half moon using a device for measuring their length, which is mounted on one seam-holder to the upper point of each commissure, which is the reference point, that is, "0" and to the next adjacent seam-holder according to paragraph (3) thus, measuring the length of three populions, and if the difference in lengths does not exceed 4 mm, then operations are possible; 5) determine the middle lowest point on each fibrous crescent by dividing the length of the fibrous crescent, found in paragraph (4), by two and measuring it; 6) the sash prosthesis is sutured - (non-stop), made in the form of a universal sash from synthetic material or xenopericardium, starting from the lowest point of the sash prosthesis and the point outlined in paragraph (5) in two directions towards the commissures, not reaching 5 mm to the upper point of the crescent moon and up to the protruding part of the neo-outbreaks 7) sew three imperfections according to paragraph (6) with synthetic threads; 8) form commissures by sewing on them two adjacent neuromuscles located next to them, both one and the second with synthetic threads, creating a cross in the commissures of the seam crosswise so that the upper edges of the prosthetic folds coincide; 9) close the incision of the aorta with a double-row suture.

The goal is achieved in that the template for cutting out the valves of the aortic valve according to the invention has the shape of a 155 degree circle segment, a radius of 1.7-1.9 cm, made of stainless steel and provided with protruding parts for fixing the valves in the area of the valve commissures.

This goal is achieved in that the device for measuring the length of the fibrous crescent moon, which is a template made of stainless steel and having the shape of an inverted letter "Ω", with a scale from 0 to 62 mm applied to the template, and a hole for attaching the template to the upper point of the commissure when measuring the length of the fibrous hemunia from the zero position of the scale to the upper point of the adjacent commissure.

It is with the help of the claimed templates for cutting the aortic valve cusps and for measuring the length of the fibrous crescent according to the method that simplifies the prosthetics of the aortic valve cusps, the predictability of the result of the operation, and also reduces the likelihood of degeneration of the autopericardium by replacing it with synthetic material or xenopericardium

This allows us to conclude that the claimed invention are interconnected by a single inventive concept.

The essence of the proposed invention lies in the fact that after measuring the diameter of the fibrous ring and the length of the fibrous crescent with a special length meter, the possibility of performing an operation is determined, the essence of which is in prosthetics of the aortic valve leaflets with leaf prostheses made of synthetic material / or xenopericardium cut out in the shape of a universal leaf . A special device for measuring the length of the fibrous crescent moon allows you to determine the length of an elastic structure that is quite complex in shape; it is almost impossible to do this with other known meters. Measurement of the length of the fibrous half moon allows you to avoid errors in the fixation of the omissions, which can be caused by different lengths of the fibrous half moon among themselves and the standardly identical omissions (one standard element). Using a template for cutting out the shape of a universal sash allows you not to waste time on the introoperative production of sashes and make the operation easily repeatable. The use of synthetic material or xenopericardium allows counting on the long functioning of the valves without the risk of their degenerative changes and the development of aortic valve insufficiency in the long term.

Comparison of the claimed technical solutions with the prototype made it possible to establish compliance with their criterion of "novelty."

When studying other well-known technical solutions in this technical field, the features that distinguish the claimed solution from the prototype were not identified and therefore provide the claimed technical solution with the criterion of "inventive step".

The combination of the above tricks allows you to: prepare the valves in advance by cutting using a template that has the shape of a universal valve, avoid calcification of new valves in the long term, minimize this probability, and reduce the likelihood of developing aortic insufficiency in the long term associated with degenerative processes in the leaf. The use of a length meter for fibrous crescents with the condition that the difference in their lengths should not exceed 4 mm makes it possible to exclude asymmetric valves from the prosthetics process, which is extremely important when using the same aortic valve leaf prostheses, and also allows you to standardize the stages of the aortic valve leaf prosthetics operation and make this procedure easy to repeat.

The implementation of the proposed method of prosthetics of the valves of the aortic valve using templates will be explained in more detail with reference to the accompanying drawings.

In Fig.1 - a template for cutting out the valves of the aortic valve - the shape of a universal valve.

In Fig.2 - a device for measuring the length of the fibrous crescent - the shape of the meter length of the fibrous crescent.

Figure 3 - technique for measuring the length of the fibrous crescent.

Figure 4 - suturing the sash to the fibrous half moon.

Figure 5 - the beginning of the formation of the commissure.

Figure 6 - formed commissure.

In Fig.7 is a view of the stitched sashes in closed form.

On Fig is a view of the stitched sashes in open form.

A device for implementing the method of prosthetics of the aortic valve flaps includes a template for cutting out the aortic valve flaps, which consists of the shape of a universal flap 1 (Fig. 1) having the shape of a 155 degree segment of a circle 2 with a radius of 1.7-1.9 cm (Fig. 1) made of stainless steel and provided with a protruding part 3 of 5 mm length for fixing the flaps in the region of the valve commissure (FIG. 5), as well as a device for measuring the length of the fibrous crescent 4 (FIG. 2), made with a scale of 5 from 0 to 62 mm and hole 6 which has a diameter tr of 1.5 mm and corresponds to a point "0" of the scale of reference.

To implement the method of prosthetics of the valves of the aortic valve, the commissures 7 (Fig. 5), the fibrous ring 8 (Fig. 4), which includes three fibrous semilunar 9 (Fig. 3), the middle of the lower semicircle of the valve 10 are the lowest point of the valve prosthesis (figure 1), the middle of the fibrous crescent 11 - the lowest point of the fibrous crescent (figure 3), the left coronary valve 12 (Fig.7, 8), the right coronary valve 13 (Fig.7, 8), point 14 (Fig .1) - the starting point of the protruding part 3 (Fig. 1), non-coronary flaps 15 (Figs. 7, 8), a new commissure 16 (Fig. 6) of the upper edges rock 17 (Fig.6), seams-holders 18 (Fig.3), which are located at the upper points of each half moon or at the upper points of each commissure, thread 19 (Fig.5) of node 20 (Fig.6), non-stop 21 - prosthesis sash (figure 4 and figure 5).

Using a device for measuring the length of the fibrous crescent 4 (figure 2) measure each crescent 9 (figure 3). The length meter of the fibrous crescent 4 is a special shape resembling the inverted letter “Ω” with marking 5 at the end (Fig. 2), and the beginning of the marking is the point “0”, made in the form of a hole 6. Using alternately stitch-holders on commissures 7 ( 4), find the length of each fibrous crescent 9 to the upper point 18 of the next commissure 7, along the way find the middle of the fibrous crescent 11 by dividing the distance found in half and marking it with a separate seam with synthetic thread. If the lengths of the fibrous half moon 9 (FIG. 3) do not differ from each other more than 4 mm, then the operation is feasible. The prosthesis of the sash is made in operation by cutting them in the form of a universal sash 1 (Fig. 1) - non-sash 21 (Fig. 4) of synthetic material or xenopericardium with a mark in the middle of the lower semicircle of the sash 10 (Fig. 1). Due to the simplicity of the shape of the universal leaf 1 (Fig. 1), this procedure takes 3-5 minutes.

The method is as follows.

At a level of 1 cm above the discharge of the right coronary artery, the ascending aorta is intersected by 3/4 of its diameter. Two suture-holders are placed on the upper part of the dissected aorta (not shown in the drawing), two holders on the lower part of the aorta (not shown in the drawing) and three suture-holders 18 (Fig. 3) for each commissure 7 (Fig. 5). Excised aortic valve leaves are excised. The operation is feasible under two conditions: firstly, the diameter of the fibrous ring 8 (figure 4) should be from 21 to 26 mm, and secondly, it is necessary that the lengths of the three fibrous half moon 9 (figure 3) do not differ from each other more than 4 mm After finding the middle of each fibrous semilunar 11 (Fig. 3), marking them with separate sutures, they start prosthetics of the sashes with the help of non-stoppers 21 (we are talking about one element - the sash) (Fig. 4), cut out according to the template of the universal sash 1 (Fig. 1) ) Start with the left coronary valve 12 (Fig.7, 8). The sash prosthesis is fixed to the middle of the fibrous half moon 11 (Fig. 3) by flashing the middle of the lower semicircle of the sash 10 (Fig. 1). Next, the prosthesis is fixed from the bottom up in two directions, not reaching 5 mm to the upper points of the crescent moon 18 (Fig. 3) from the fibrous crescent moon 9 (Fig. 3) and to point 14 (Fig. 1) on the non-stop 21 (Fig. 4) ), where the protruding part 3 (Fig. 1) begins. Then, the same manipulations are performed with the prosthesis of the right coronary valve 13 (Figs. 7, 8). The third is fixed non-coronary leaf 15 (Fig.7, 8). Next, new commissures 16 are formed (Fig. 6) by stitching two adjacent neo-remnants 21

An example implementation of the method, performed on a human corpse.

On the human corpse was produced:

1. Sternotomy.

2. Pericardiotomy.

3. Pinch the aorta just below the discharge of the brachiocephalic trunk

4. Cross the aorta 1 cm above the site of discharge of the right coronary artery 3/4 of its diameter.

5. Apply three suture-holders to the commissures (suture thread 4/0), two to the edges of the aortic incision (p-shaped with capture of two walls of the aorta, on Teflon pads, suture thread 4/0) and two to the upper part of the dissected aorta and two on its lower part (etibond thread 3/0).

6. Excised aortic valve leaves are excised.

7. Using aortic patterns, measure the diameter of the fibrous ring of the aortic valve, if the diameter of the latter is 21-26 mm, continue to work further, if not, use either mechanical or biological valves.

8. A seam-holder between the coronary flaps is stitched with a length meter for the fibrous crescent through the hole “0” and fixed with one seam.

9. The meter is placed along the fibrous crescent and find the distance to the stitch-seam between the right coronary and non-coronary cusps; on the fibrous crescent, mark the place of the middle of the distance found by dividing the length of the crescent by two.

10. The procedures of claim 9 are performed with a commissure between the left coronary and non-coronary leaflets, and then with a commissure between the non-coronary and right coronary leaflets.

11. If the length of the fibrous half moon, determined according to paragraphs 9 and 10, does not differ from each other by more than 4 mm, then the operation of prosthetics of the valves is continued.

12. Take pre-cut according to the template universal flap of synthetic material with a thickness of 0.1-0.3 mm or xenopericardium of the flap of the aortic valve (nevostoriki) with the middle of the semicircular part marked.

13. A non-stop is fixed in the position of the left coronary, starting from the first suture passing through the middle of the non-stop and marked according to claim 9-10, the middle of the fibrous crescent (proline 5/0 thread, 13 mm needle).

14. The seam is continued from the bottom upwards in both directions, not reaching 5 mm to the edge of the commissures and to the protruding part of the omission.

15. Repeat the procedure according to PP.13-14 in relation to the right coronary leaf

16. Repeat the procedure according to claims 13-14 with respect to the non-coronary leaf.

17. A commissure is formed between the left and right coronary cusps by stitching the neo-remnants and commissures according to the scheme - left unlabeling - commissure - right unlatching with thread from the left unlatching and according to the scheme of right unlatching - commissure - left unlatching with thread from the side of the right coronary unlatching so that at the level of the formed new commissure, the seams went crosswise, paying special attention to the equal distance of the injections on both nevostok from their upper edge, which should coincide exactly after the formation of commissures s.

18. Sutures puncture the aorta and tie on a teflon pad.

19. The techniques of paragraphs 17-18 are repeated with respect to the formation of a commissure between the left coronary and non-coronary neuromuscular.

20. Repeat the techniques of claims 17-18 with respect to the formation of a commissure between the right coronary and non-coronary neuromuscular.

21. Check the cooptation of the imperfections of the aortic valve using a hydraulic test.

22. Use sutures-holders at the corners of the aortic incision, the latter is sutured with a two-row suture.

23. Remove the clamp from the aorta.

The results obtained allow us to expect that the proposed method will find wide application in aortic valve surgery.

The proposed method of prosthetics of the valves of the aortic valve and device for its implementation allow:

1. Prepare the sash in advance by cutting out using the shape of the universal sash.

2. Avoid calcification of new valves in the long term due to their manufacture from synthetic material or minimize the likelihood of calcification when using xenopericardium.

3. To reduce the likelihood of developing in the long-term period of aortic insufficiency associated with degenerative processes in the leaflet.

4. To make this procedure predictable through the use of a meter for the length of the fibrous crescent moon, which allows it to be performed only in patients with almost the same length of fibrous crescent moon, ie identical in shape nevostroki are sewn to the same length of fibrous semilunar moons.

5. To standardize the stages of the operation of prosthetics of the valves of the aortic valve, to make this procedure easily repeatable.

Claims (3)

1. The method of prosthetics of the valves of the aortic valve, including excision of the affected valves, measurement, cutting the valves, sewing them to fibrous crescents and the formation of commissures, characterized in that as prosthetic valves use flaps made of synthetic fabrics or xenopericardium, which are cut according to the pattern according to p .2, where the leaf prosthesis starts between the lowest point of the leaf prosthesis and the lowest point of the fibrous crescent, continuing to fix the leaf prosthesis from the bottom up up to 5 mm to the top It points to a half moon, and the protruding portion neostvorok then form three new commissures of the aortic valve by sewing neostvorok and adjacent commissures of the aortic valve. 2. A template for cutting out the valves of the aortic valve, characterized in that it has the shape of a 155-degree circle segment with a radius of 1.7-1.9 cm, made of stainless steel and equipped with protruding parts of the fixation of the valves in the area of the valve commissures. 3. A device for measuring the length of the fibrous crescent moon, which is a template made of stainless steel and having the shape of an inverted letter “Ω”, with a scale from 0 to 62 mm applied to the template, and a hole for attaching the template to the top point commissure when measuring the length of the fibrous crescent from the zero position of the scale to the upper point of the adjacent commissure.

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